AMAG PHARMACEUTICALS INC. (Form: 10-Q, Received: 05/06/2010 16:09:14)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

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

For the quarterly period ended March 31, 2010

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

For the transition period from to

Commission File Number 0-14732

AMAG PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware		04-2742593
(State or Other Jurisdiction of		(IRS Employer
Incorporation or Organization)		Identification No.)

100 Hayden Avenue
Lexington, Massachusetts		02421
(Address of Principal Executive Offices)		(Zip Code)

(617) 498-3300

(Registrant’s Telephone Number, Including Area Code)

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes o No o

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer x		Accelerated filer o

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

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

As of May 3, 2010 there were 21,011,472 shares of the registrant’s Common Stock, par value $.01 per share, outstanding.

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AMAG PHARMACEUTICALS, INC.

FORM 10-Q

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PART I.	FINANCIAL INFORMATION (Unaudited)
Item 1.	Financial Statements
	Condensed Consolidated Balance Sheets as of March 31, 2010 and December 31, 2009	4
	Condensed Consolidated Statements of Operations for the three months ended March 31, 2010 and 2009	5
	Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2010 and 2009	6
	Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2010 and 2009	7
	Notes to Condensed Consolidated Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	26
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	45
Item 4.	Controls and Procedures	45

PART II.	OTHER INFORMATION
Item 1.	Legal Proceedings	46
Item 1A.	Risk Factors	46
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	70
Item 6.	Exhibits	71

SIGNATURES

CERTIFICATIONS

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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements.

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AMAG PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA)

( Unaudited )

	March 31, 2010			December 31, 2009
*ASSETS*
Current assets:
Cash and cash equivalents	$	212,747		$	50,126
Short-term investments	21,044			29,578
Settlement rights	788			788
Accounts receivable, net	15,004			27,350
Inventories	12,041			9,415
Receivable from collaboration	60,000			—
Prepaid and other current assets	4,900			5,472
Total current assets	326,524			122,729
Property, plant and equipment, net	12,064			12,417
Long-term investments	48,432			49,013
Restricted cash	460			460
Total assets	$	387,480		$	184,619
*LIABILITIES AND STOCKHOLDERS’ EQUITY*
Current liabilities:
Accounts payable	$	4,146		$	5,432
Accrued expenses	20,515			21,931
Deferred revenues	14,258			10,198
Total current liabilities	38,919			37,561
Long-term liabilities:
Deferred revenues	55,000			1,000
Other long-term liabilities	3,011			3,081
Total liabilities	96,930			41,642
Commitments and contingencies (Note K & L)
Stockholders’ equity:
Preferred stock, par value $0.01 per share, 2,000,000 shares authorized; none issued	—			—
Common stock, par value $0.01 per share, 58,750,000 shares authorized; 20,993,285 and 17,362,710 shares issued and outstanding at March 31, 2010 and December 31, 2009, respectively	210			174
Additional paid-in capital	603,140			432,414
Accumulated other comprehensive loss	(8,061		)	(7,925		)
Accumulated deficit	(304,739		)	(281,686		)
Total stockholders’ equity	290,550			142,977
Total liabilities and stockholders’ equity	$	387,480		$	184,619

The accompanying notes are an integral part of the condensed consolidated financial statements.

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AMAG PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(IN THOUSANDS, EXCEPT PER SHARE DATA)

( Unaudited )

	Three Months Ended March 31,
	2010			2009
Revenues:
Product sales, net	$	13,295		$	393
License fees	—			516
Royalties	11			47
Total revenues	13,306			956
Costs and expenses:
Cost of product sales	1,010			61
Research and development expenses	12,368			11,072
Selling, general and administrative expenses	23,456			17,750
Total costs and expenses	36,834			28,883
Other income (expense):
Interest and dividend income, net	471			1,256
Gains on investments, net	4			992
Fair value adjustment of settlement rights	—			(923		)
Total other income (expense)	475			1,325
Net loss before income taxes	(23,053		)	(26,602		)
Income tax benefit	—			179
Net loss	$	(23,053	)	$	(26,423	)

Net loss per share:
Basic and diluted	$	(1.15	)	$	(1.55	)

Weighted average shares outstanding used to compute net loss per share:
Basic and diluted	19,985			17,021

The accompanying notes are an integral part of the condensed consolidated financial statements.

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AMAG PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(IN THOUSANDS)

( Unaudited )

	Three Months Ended March 31,
	2010			2009

Net loss	$	(23,053	)	$	(26,423	)
Other comprehensive income (loss):
Unrealized gains (losses) on securities:
Holding (losses) gains arising during period, net of tax	(136		)	2,201
Reclassification adjustment for losses and gains, net, included in net loss	—			4
Net unrealized (losses) gains	(136		)	2,205
Total comprehensive loss	$	(23,189	)	$	(24,218	)

The accompanying notes are an integral part of the condensed consolidated financial statements.

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AMAG PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(IN THOUSANDS)

( Unaudited )

	Three Months Ended March 31,
	2010			2009
Net loss	$	(23,053	)	$	(26,423	)
Cash flows from operating activities:
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation	570			442
Non-cash equity-based compensation expense	4,301			3,502
Amortization of premium/discount on purchased securities	33			204
Fair value adjustment of settlement rights	—			923
Gains on investments, net	(4		)	(992		)
Changes in operating assets and liabilities:
Accounts receivable	12,346			171
Inventories	(2,500		)	38
Prepaid and other current assets	572			1,396
Accounts payable and accrued expenses	(2,702		)	(1,283		)
Deferred revenues	(1,940		)	(403		)
Other long-term liabilities	(70		)	—
Total adjustments	10,606			3,998
Net cash used in operating activities	(12,447		)	(22,425		)

Cash flows from investing activities:
Proceeds from sales or maturities of available-for-sale investments	8,950			26,595
Purchase of available-for-sale investments	—			(310		)
Capital expenditures	(217		)	(192		)
Change in restricted cash	—			61
Net cash provided by investing activities	8,733			26,154

Cash flows from financing activities:
Proceeds from the exercise of stock options	776			77
Proceeds from the issuance of common stock, net of underwriting discount and other expenses	165,559			—
Net cash provided by financing activities	166,335			77

Net increase in cash and cash equivalents	162,621			3,806
Cash and cash equivalents at beginning of the period	50,126			64,182
Cash and cash equivalents at end of the period	$	212,747		$	67,988

The accompanying notes are an integral part of the condensed consolidated financial statements.

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AMAG PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

MARCH 31, 2010

( Unaudited )

A. Description of Business

AMAG Pharmaceuticals, Inc., a Delaware corporation, was founded in 1981. We are a biopharmaceutical company that utilizes our proprietary technology for the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia, or IDA, and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease. We currently manufacture and sell two approved products, Feraheme ® (ferumoxytol) Injection for intravenous, or IV, use and GastroMARK ® .

GastroMARK, our oral contrast agent used for delineating the bowel in magnetic resonance imaging, is approved and marketed in the U.S., Europe and other countries through our marketing partners.

We are subject to risks common to companies in the pharmaceutical industry including, but not limited to, our sole dependence on the success of Feraheme , development by us or our competitors of new technological and product innovations, uncertainty regarding market acceptance of our products, uncertainties related to insurance coverage, coding and third-party reimbursement for our products, our limited experience commercializing and distributing a pharmaceutical product, our reliance on Takeda to commercialize Feraheme in certain territories outside of the U.S., our potential inability to operate our manufacturing facility in compliance with current good manufacturing practices, our potential inability to obtain raw materials and manufacture sufficient quantities of our products, the potential fluctuation of our operating results, potential differences between actual future results and the estimates or assumptions used by us in preparation of our condensed consolidated financial statements, the volatility of our stock price, our potential inability to become profitable in the future, our potential inability to obtain additional financing, if necessary, on acceptable terms, the current credit and financial market conditions, our potential inadvertent failure to comply with reporting and payment obligations under government pricing programs, our potential inadvertent failure to comply with the regulations of the FDA or other government agencies, uncertainty of the regulatory approval process for our other Feraheme indications or for any indications outside of the U.S., uncertainty of the results of our clinical trials, our ability to manage growth, our ability to enter into and successfully maintain favorable collaborations and in-licensing arrangements, our dependence on key personnel, and uncertainties related to the protection of proprietary technology, product liability, potential legislative and regulatory changes, and potential costs and liabilities associated with currently pending or future litigation.

Throughout this Quarterly Report on Form 10-Q, AMAG Pharmaceuticals, Inc. and our consolidated subsidiaries are collectively referred to as “the Company,” “we,” “us,” or “our.”

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B. Basis of Presentation and Summary of Significant Accounting Policies

Basis of Presentation

These condensed consolidated financial statements are unaudited and, in the opinion of management, include all adjustments necessary for a fair statement of the financial position and results of operations of the Company for the interim periods presented. Such adjustments consisted only of normal recurring items. The year-end condensed consolidated balance sheet data was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the United States of America.

In accordance with accounting principles generally accepted in the United States of America for interim financial reports and the instructions for Form 10-Q and the rules of the Securities and Exchange Commission, certain information and footnote disclosures normally included in annual financial statements have been condensed or omitted. Our accounting policies are described in the Notes to the Financial Statements in our Annual Report on Form 10-K for the year ended December 31, 2009. Interim results are not necessarily indicative of the results of operations for the full year. These interim financial statements should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2009.

Use of Estimates and Assumptions

The preparation of condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent assets and liabilities. The most significant estimates and assumptions are used in, but are not limited to, revenue recognition and related sales allowances, assessing investments for potential other-than-temporary impairment and determining values of investments, reserves for doubtful accounts, accrued expenses, income taxes and equity-based compensation expense. Actual results could differ materially from those estimates.

Principles of Consolidation

The accompanying condensed consolidated financial statements include our accounts and the accounts of our wholly-owned subsidiaries, AMAG Securities Corporation and AMAG Europe Limited. AMAG Europe Limited was incorporated in October 2009 in London, England. AMAG Securities Corporation is a Massachusetts corporation that was formed in August 2007. All significant intercompany account balances and transactions between the companies have been eliminated.

Fair Value of Financial Instruments

Under current accounting standards, fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.

In January 2010, we adopted a newly issued accounting standard which requires additional disclosure about the amounts of and reasons for significant transfers in and out of Level 1 and Level 2 fair value measurements. This standard also clarifies existing disclosure requirements related to the level of disaggregation of fair value measurements for each class of assets and liabilities and disclosures about inputs and valuation techniques used to measure fair value for both recurring and nonrecurring Level 2 and Level 3 measurements. As this newly issued accounting standard only requires enhanced disclosure, the adoption of this standard did not impact our financial position or results of operations. In addition, effective for interim and annual periods beginning after December 15, 2010, this standard will require

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additional disclosure and require an entity to present disaggregated information about activity in Level 3 fair value measurements on a gross basis, rather than as one net amount.

Current accounting guidance establishes a hierarchy used to categorize how fair value is measured and which is based on three levels of inputs, of which the first two are considered observable and the last unobservable, as follows:

Level 1 - Quoted prices in active markets for identical assets or liabilities.

Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

We hold certain assets that are required to be measured at fair value on a recurring basis, including our cash equivalents, short- and long-term investments and our Settlement Rights, as defined below. The following tables represent the fair value hierarchy for those assets that we measure at fair value on a recurring basis as of March 31, 2010 and December 31, 2009 (in thousands):

	Fair Value Measurements at March 31, 2010 Using:
			Quoted Prices in Active Markets for Identical Assets		Significant Other Observable Inputs		Significant Unobservable Inputs
	Total		(Level 1)		(Level 2)		(Level 3)
Money market funds	$	207,168	$	207,168	$	—	$	—
Corporate debt securities	3,855		—		3,855		—
U.S. treasury and government agency securities	8,657		—		8,657		—
Auction rate securities	56,964		—		—		56,964
Settlement rights	788		—		—		788
	$	277,432	$	207,168	$	12,512	$	57,752

	Fair Value Measurements at December 31, 2009 Using:
			Quoted Prices in Active Markets for Identical Assets		Significant Other Observable Inputs		Significant Unobservable Inputs
	Total		(Level 1)		(Level 2)		(Level 3)
Money market funds	$	46,451	$	46,451	$	—	$	—
Corporate debt securities	9,804		—		9,804		—
U.S. treasury and government agency securities	11,247		—		11,247		—
Auction rate securities	57,540		—		—		57,540
Settlement rights	788		—		—		788
	$	125,830	$	46,451	$	21,051	$	58,328

With the exception of our ARS and Settlement Rights, which are valued using Level 3 inputs, as discussed below, the fair value of our non-money market fund investments is primarily determined from independent pricing services which use Level 2 inputs for the determination of fair value. Independent pricing services normally derive security prices from recently reported trades for identical or similar

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securities, making adjustments based upon other significant observable market transactions at fair value. At each reporting period, we perform quantitative and qualitative analyses on prices received from third parties to determine whether prices are reasonable estimates of fair value. After completing our analyses, we did not adjust or override any fair value measurements provided by our pricing services as of March 31, 2010. In addition, there were no transfers or reclassifications of any securities between Level 1 and Level 2 during the three months ended March 31, 2010.

We also analyze when the volume and level of activity for an asset or liability have significantly decreased and when circumstances indicate that a transaction may not be considered orderly. In order to determine whether the volume and level of activity for an asset or liability have significantly decreased, we assess current activity with normal market activity for the asset or liability. We rely on many factors such as trading volume, trading frequency, the levels at which market participants indicate their willingness to buy and sell our securities, as reported by market participants, and current market conditions. Using professional judgment and experience, we evaluate and weigh the relevance and significance of all applicable factors to determine if there has been a significant decrease in the volume and level of activity for an asset or group of similar assets. Similarly, in order to identify transactions that are not orderly, we take into consideration the activity in the market which can influence the determination and occurrence of an orderly transaction. Also, we inquire as to whether there may have been restrictions on the marketing of the security to a single or limited number of participants. Where possible, we assess the financial condition of the seller to determine whether observed transactions may have been forced. If the trading price for a security held by us is significantly out of line when compared to the trading prices of similar recent transactions, we consider whether this disparity is an indicator of a disorderly trade. Using professional judgment and experience, we evaluate and weigh the relevance and significance of all applicable factors to determine if the evidence suggests that a transaction or group of similar transactions is not orderly. Based upon these procedures, we determined that market activity for our non-ARS assets appeared normal and that transactions did not appear disorderly as of March 31, 2010.

In November 2008, we elected to participate in a rights offering by UBS AG, or UBS, one of our securities brokers, which provided us with rights to sell to UBS $9.3 million in par value of our ARS portfolio, at par value, at any time during a two-year sale period beginning June 30, 2010, or the Settlement Rights. In November 2008, we elected the fair value option with respect to our Settlement Rights in accordance with accounting guidance related to the fair value option for financial assets and financial liabilities. We are required to assess the fair value of both the Settlement Rights and our ARS subject to Settlement Rights and record changes each period until the Settlement Rights are exercised and our ARS subject to Settlement Rights are redeemed. Although the Settlement Rights represent the right to sell the securities back to UBS at par, we are required to periodically assess the ability of UBS to meet that obligation in assessing the fair value of the Settlement Rights.

The following table presents assets measured at fair value on a recurring basis using significant unobservable inputs (Level 3) as of March 31, 2010 (in thousands):

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	Three Months Ended March 31, 2010
Balance at beginning of period	$	58,328
Transfers to Level 3	—
Total gains (losses) (realized or unrealized):
Included in earnings	4
Included in other comprehensive income (loss)	(30		)
Purchases (settlements), net	(550		)
Balance at end of period	$	57,752
The amount of total gains (losses) for the period included in earnings attributable to the change in unrealized gains (losses) relating to assets still held at end of period	$	4

Gains and losses (realized and unrealized) included in earnings in the table above are reported in other income (expense) in our condensed consolidated statement of operations.

Revenue Recognition

Net Product Sales

We recognize net product sales in accordance with current accounting guidance related to the recognition, presentation and disclosure of revenue in financial statements, which outlines the basic criteria that must be met to recognize revenue. We recognize revenue when:

· persuasive evidence of an arrangement exists;

· delivery of product has occurred or services have been rendered;

· the sales price charged is fixed or determinable; and

· collection is reasonably assured.

We record product sales allowances and accruals related to prompt payment discounts, chargebacks, governmental and other rebates, distributor, wholesaler and group purchasing organization, or GPO, fees, and product returns as a reduction of revenue in our condensed consolidated statement of operations at the time product sales are recorded. Calculating these gross-to-net sales adjustments involves estimates and judgments based primarily on actual Feraheme sales data and forecasted customer buying patterns blended with historical experience of products similar to Feraheme sold by others. In addition, we also monitor our distribution channel to determine the level of additional allowances or accruals required based on inventory in our sales channel. There were no product sales allowances or accruals for the three months ended March

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31, 2009. An analysis of our product sales allowances and accruals for the three months ended March 31, 2010 is as follows (in thousands):

	March 31, 2010
Product sales allowances and accruals:
Discounts and chargebacks	$	742
Government and other rebates	3,001
Returns	244
Total product sales allowances and accruals	$	3,987

Total net product sales	$	13,295

Total gross product sales	$	17,282

Total product sales allowances and accruals as a percent of total gross product sales	23		%

Product sales allowances and accruals are primarily comprised of both direct and indirect fees, discounts and rebates and provisions for estimated product returns. Direct fees, discounts and rebates are contractual fees and price adjustments payable to wholesalers, specialty distributors and other customers that purchase products directly from us. Indirect fees, discounts and rebates are contractual price adjustments payable to healthcare providers and organizations, such as certain dialysis organizations, physicians, clinics, hospitals, and GPOs that typically do not purchase products directly from us but rather from wholesalers and specialty distributors. In accordance with guidance related to accounting for fees and consideration given by a vendor to a customer (including a reseller of a vendor’s products), these fees, discounts and rebates are presumed to be a reduction of the selling price of Feraheme . Product sales allowances and accruals are based on definitive contractual agreements or legal requirements (such as Medicaid laws and regulations) related to the purchase and/or utilization of the product. Allowances and accruals are recorded in the same period that the related revenue is recognized and are estimated using either historical, actual and/or other data, including estimated patient usage, applicable contractual rebate rates, contract performance by the benefit providers, other current contractual and statutory requirements, historical market data based upon experience of other similar products to Feraheme , specific known market events and trends such as competitive pricing and new product introductions and current and forecasted customer buying patterns and inventory levels, including the shelf life of our products. As part of this evaluation, we also review changes to federal legislation, changes to rebate contracts, changes in the level of discounts, and changes in product sales trends. Reserve estimates are evaluated quarterly and may require adjustments to better align our estimates with actual results. During the three months ended March 31, 2010, our allowances for government and other rebates reflected a decrease of $0.3 million relating to sales in the prior year. This adjustment was primarily the result of a reduction in our estimates of Medicaid utilization across Feraheme customer classes resulting from additional data, including information regarding Medicaid claims experience for comparable products, partially offset by an increase in estimated Medicaid allowances associated with the increase in statutory minimum rebate rates included in recent healthcare legislation. Although allowances and accruals are recorded at the time of product sale, certain rebates are typically paid out, on average, up to six months or longer after the sale. If actual future results vary from our estimates, we may need to adjust our previous estimates, which would affect our earnings in the period of the adjustment.

Deferred Revenue - Launch Incentive Program

During the third quarter of 2009, certain dialysis organizations purchased Feraheme from us under our Launch Incentive Program. These purchases were made under agreements which provided these customers

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with an opportunity to purchase Feraheme through September 30, 2009 at discounted pricing and further provided for extended payment terms and expanded rights of return. As a result, in accordance with current accounting guidance which requires that we defer recognition of revenues until we can reasonably estimate returns related to those purchases, we have deferred the recognition of revenues associated with these purchases until our customers report to us that such inventory has been utilized in their operations. Any purchases returned to us will not be recorded as revenue. Accordingly, as of March 31, 2010, we have a remaining balance of $8.3 million in deferred revenues, which represents product purchased under the Launch Incentive Program which remained held by the dialysis organizations at March 31, 2010, net of any applicable discounts and estimated rebates, which are included in our commercial rebate accruals as of March 31, 2010. In addition, we have deferred the related cost of product sales of approximately $0.2 million and recorded such amount as finished goods inventory held by others as of March 31, 2010. Because we are unable to reasonably estimate the amount of inventory that may be returned under this program, if any, we cannot provide any assurance that amounts reported as deferred revenue and associated with this program will be utilized by our customers and thereby recorded by us as product revenues in our future condensed consolidated statements of operations.

License Fee and Other Collaboration Revenues

The terms of product development agreements entered into between us and our collaborative partners may include non-refundable license fees, payments based on the achievement of certain milestones and performance goals and royalties on any product sales derived from those collaborations. We recognize license fee and research and development revenue under collaborative arrangements over the term of the applicable agreements on a straight-line basis or through the application of a proportional performance model where revenue is recognized equal to the lesser of the amount due under the agreements or the amount based on the proportional performance to date. In cases where project costs or other performance metrics are estimable, we recognize nonrefundable payments and fees for the licensing of technology or intellectual property rights over the related performance period or when there are no remaining performance obligations. In cases where project costs or other performance metrics are not estimable but there is an established contract period, revenues are recognized on a straight line basis over the term of the relevant agreement. Nonrefundable payments and fees are recorded as deferred revenue upon receipt and may require deferral of revenue recognition to future periods.

Multiple Element Arrangements

We evaluate revenue from arrangements that have multiple elements to determine whether the components of the arrangement represent separate units of accounting as defined in the accounting guidance related to revenue arrangements with multiple deliverables, which provides that an element of a contract can be accounted for separately if the delivered elements have stand-alone value and the fair value of any undelivered elements is determinable. If an element is considered to have standalone value but the fair value of any of the undelivered items cannot be determined, all elements of the arrangement are recognized as revenue over the period of performance for such undelivered items or services.

Concentrations and Significant Customer Information

As of March 31, 2010 we had approximately $163.9 million of our total $212.7 million cash and cash equivalents balance invested in a single institutional money market fund, which is collateralized solely by U.S. Treasury and U.S. government agency securities.

Our operations are located solely within the U.S. We are focused principally on developing, manufacturing and commercializing an IV iron replacement therapeutic agent and novel imaging agents.

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We perform ongoing credit evaluations of our customers and generally do not require collateral. The following table sets forth customers who represented 10% or more of our revenues for the three months ended March 31, 2010 and 2009.

	Three Months Ended March 31,
	2010	2009
Metro Medical Supply, Inc.	36%	—
AmerisourceBergen Drug Corporation	29%	—
Guerbet S.A.	< 10%	33%
Covidien, Ltd.	< 10%	13%
Bayer Healthcare Pharmaceuticals	—	54%

Revenues from customers outside of the U.S., principally in Europe, amounted to less than 10.0% and 33.0% of our total revenues for the three months ended March 31, 2010 and 2009, respectively.

Subsequent Events

We did not have any material recognizable subsequent events.

C. Investments

At March 31, 2010 and December 31, 2009, the combined total of our short- and long-term investments was $69.5 million and $78.6 million, respectively, and consisted of securities classified as trading and available-for-sale in accordance with accounting standards which provide guidance related to accounting and classification of certain investments in debt and equity securities.

The following is a summary of our available-for-sale and trading securities at March 31, 2010 and December 31, 2009 (in thousands):

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	March 31, 2010
			Gross		Gross			Estimated
	Amortized		Unrealized		Unrealized			Fair
	Cost		Gains		Losses			Value
Short-term investments:
Corporate debt securities
Due in one year or less	$	3,485	$	54	$	—		$	3,539
Due in one to three years	305		11		—			316
U.S. treasury and government agency securities
Due in one year or less	4,272		43		—			4,315
Due in one to three years	4,255		87		—			4,342
Auction rate securities - trading
Due in one year or less	—		—		—			—
Due after five years	8,532		—		—			8,532
Total short-term investments	$	20,849	$	195	$	—		$	21,044

Long-term investments:
Auction rate securities - available for sale
Due in one year or less	$	55,600	$	—	$	(7,168	)	$	48,432
Due after five years	—		—		—			—
Total long-term investments	$	55,600	$	—	$	(7,168	)	$	48,432

Total short and long-term investments	$	76,449	$	195	$	(7,168	)	$	69,476

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	December 31, 2009
			Gross		Gross			Estimated
	Amortized		Unrealized		Unrealized			Fair
	Cost		Gains		Losses			Value
Short-term investments:
Corporate debt securities
Due in one year or less	$	8,580	$	61	$	—		$	8,641
Due in one to three years	1,117		46		—			1,163
U.S. treasury and government agency securities
Due in one year or less	8,532		136		—			8,668
Due in one to three years	2,521		58		—			2,579
Auction rate securities - trading
Due in one year or less	—		—		—			—
Due after five years	8,527		—		—			8,527
Total short-term investments	$	29,277	$	301	$	—		$	29,578

Long-term investments:
Auction rate securities - available for sale
Due in one year or less	$	—	$	—	$	—		$	—
Due after five years	56,150		—		(7,137		)	49,013
Total long-term investments	$	56,150	$	—	$	(7,137	)	$	49,013

Total short and long-term investments	$	85,427	$	301	$	(7,137	)	$	78,591

Auction Rate Securities and UBS Settlement Rights

At March 31, 2010, we held a total of $56.9 million in fair market value of ARS, reflecting a decline in value of approximately $8.0 million compared to the par value of these securities of $64.9 million. Of the $8.0 million decline in value, approximately $7.2 million was considered a temporary impairment and was reported as an unrealized loss in accumulated other comprehensive loss at March 31, 2010. The remaining $0.8 million represented a trading loss associated with our UBS ARS, the recording of which is described below. Of our total ARS, $48.4 million in fair market value are not subject to Settlement Rights and are classified as available-for-sale. The remaining $8.5 million are subject to Settlement Rights and are classified as trading securities. At March 31, 2010, all of our ARS were municipal bonds with an auction reset feature. The substantial majority of our ARS portfolio was rated AAA as of March 31, 2010 by at least one of the major securities rating agencies and was primarily collateralized by student loans substantially guaranteed by the U.S. government under the Federal Family Education Loan Program. In February 2008, our ARS began to experience failed auctions and have continued to experience failed auctions. As a result of the lack of observable ARS market activity since that time, we use a discounted cash flow analysis to value these securities as opposed to valuing them at par value. Our valuation analysis considers, among other items, assumptions that market participants would use in their estimates of fair value, such as the collateral underlying the security, the creditworthiness of the issuer and any associated guarantees, credit ratings of the security by the major securities rating agencies, the ability or inability to sell the investment in an active market, the timing of expected future cash flows, and the expectation of the next time the security will have a successful auction or when call features may be exercised by the issuer. Based upon this methodology, we have estimated the fair value of our ARS

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subject to Settlement Rights to be $8.5 million at March 31, 2010 and, accordingly, we recorded realized gains of approximately $4,000 during the three months ended March 31, 2010. In addition, based upon this methodology, we have estimated the fair value of our remaining ARS not subject to Settlement Rights to be $ 48.4 million at March 31, 2010, and have recorded a $7.2 million unrealized loss to accumulated other comprehensive loss as of March 31 , 2010. As discussed in greater detail below, for all available-for-sale debt securities with unrealized losses, management performs an analysis to assess whether we intend to sell or whether we would more likely than not be required to sell the security before the expected recovery of the amortized cost basis. Where we intend to sell a security, or may be required to do so, the security’s decline in fair value is deemed to be other-than-temporary and the full amount of the unrealized loss is recorded in our condensed consolidated statement of operations as an impairment loss. Regardless of our intent to sell a security, we perform additional analyses on all securities with unrealized losses to evaluate whether there could be a credit loss associated with the security. We did not recognize any credit losses related to our securities during the three months ended March 31, 2010. As of March 31, 2010, all of our ARS continue to pay interest according to their stated terms.

In November 2008, we elected to participate in a rights offering by UBS which provided us with the right to sell to UBS $9.3 million in par value of our ARS portfolio, at par value, at any time during a two-year sale period beginning June 30, 2010. By electing to participate in the rights offering, we granted UBS the right, exercisable at any time prior to June 30, 2010 or during the two-year sale period, to purchase or cause the sale of our ARS at par value, or the Call Right. UBS has stated that it will only exercise the Call Right for the purpose of restructurings, dispositions or other solutions that will provide its clients with par value for their ARS. UBS has agreed to pay its clients the par value of their ARS within one day of settlement of any Call Right transaction. Notwithstanding the Call Right, we are permitted to sell the ARS to parties other than UBS, which would extinguish the Settlement Rights.

Due to our belief that the market for ARS may take in excess of twelve months to fully recover, we have classified our portfolio of ARS not subject to Settlement Rights as long-term investments in our condensed consolidated balance sheet at March 31, 2010. As discussed in greater detail below, we believe that the temporary impairment related to our ARS not subject to Settlement Rights is primarily attributable to the lack of liquidity of these investments, coupled with the ongoing turmoil in the credit and capital markets, and we have no reason to believe that any of the underlying issuers of our ARS are presently at risk of default. Any future fluctuation in fair value related to our ARS not subject to Settlement Rights that we deem to be temporary, including any recoveries of previous write-downs, would be recorded to accumulated other comprehensive loss. If we determine that any future unrealized loss is other-than-temporary, we will record a charge to our condensed consolidated statement of operations. In the event that we need to access our investments in these securities, we will not be able to do so until a future auction is successful, the issuer calls the security pursuant to a mandatory tender or redemption prior to maturity, a buyer is found outside the auction process, or the securities mature. For all of our ARS, the underlying maturity date is in excess of one year, and the majority have final maturity dates of 30 to 40 years in the future. We believe we will ultimately be able to liquidate our investments without significant loss prior to the maturity dates noted above primarily due to the collateral securing most of our ARS. However, it could take until final maturity of the ARS to realize our investments’ par value. In addition, as part of our determination of the fair value of our investments, we consider credit ratings provided by independent investment rating agencies as of the valuation date. These ratings are subject to change, and we may be required to adjust our future valuation of these ARS which may adversely affect the value of these investments.

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Impairments and Unrealized Gains and Losses on Investments

The following is a summary of the fair value of our investments with unrealized losses that are deemed to be temporarily impaired and their respective gross unrealized losses aggregated by investment category and length of time that individual securities have been in a continuous unrealized loss position at March 31, 2010 and December 31, 2009 (in thousands):

	March 31, 2010
	Less than 12 Months				12 Months or Greater					Total
	Fair		Unrealized		Fair		Unrealized			Fair		Unrealized
	Value		Losses		Value		Losses			Value		Losses
Auction rate securities	$	—	$	—	$	48,432	$	(7,168	)	$	48,432	$	(7,168	)
	$	—	$	—	$	48,432	$	(7,168	)	$	48,432	$	(7,168	)

	December 31, 2009
	Less than 12 Months				12 Months or Greater					Total
	Fair		Unrealized		Fair		Unrealized			Fair		Unrealized
	Value		Losses		Value		Losses			Value		Losses
Auction rate securities	$	—	$	—	$	49,013	$	(7,137	)	$	49,013	$	(7,137	)
	$	—	$	—	$	49,013	$	(7,137	)	$	49,013	$	(7,137	)

As noted above, for available-for-sale debt securities with unrealized losses, we perform an analysis to assess whether we intend to sell or whether we would more likely than not be required to sell the security before the expected recovery of the amortized cost basis. Where we intend to sell a security, or may be required to do so, the security’s decline in fair value is deemed to be other-than-temporary and the full amount of the unrealized loss is recorded in our condensed consolidated statement of operations as an impairment loss. Regardless of our intent to sell a security, we perform additional analyses on all securities with unrealized losses to evaluate whether there could be a credit loss associated with the security.

Based upon our evaluation, we did not consider the unrealized losses on our available-for-sale investments at March 31, 2010 and December 31, 2009 to be other-than-temporary impairments. Accordingly, no impairment losses were recognized in our condensed consolidated statement of operations related to available-for-sale securities during the three months ended March 31, 2010.

Future events may occur, or additional information may become available, which may cause us to identify credit losses where we do not expect to receive cash flows sufficient to recover the amortized cost basis of a security and which may necessitate the recording of future realized losses on securities in our portfolio. Significant losses in the estimated fair values of our investments could have a material adverse effect on our earnings in future periods.

Realized Gains and Losses

Gains and losses are determined on the specific identification method and, accordingly, during the three months ended March 31, 2010 and 2009 we recorded gains of approximately $4,000 and $1.0 million, respectively, to our condensed consolidated statement of operations principally related to our estimated valuation of ARS subject to Settlement Rights. We did not record any realized gains or losses related to the fair value adjustment of our Settlement Rights during the three months ended March 31, 2010. We recorded a realized loss related to the fair value adjustment of our Settlement Rights of $0.9

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million to our condensed consolidated statement of operations during the three months ended March 31, 2009.

D. Accounts Receivable

Our accounts receivable were $15.0 million and $27.4 million at March 31, 2010 and December 31, 2009, respectively. At March 31, 2010 and December 31, 2009, our accounts receivable primarily represented amounts due from wholesalers and distributors to whom we sell Feraheme directly and customers who participated in the Launch Incentive Program . Accounts receivable are recorded net of reserves for estimated chargeback obligations, prompt payment discounts and any allowance for doubtful accounts. Reserves for other sales related allowances such as rebates, distribution and other fees, and product returns are included in accrued expenses in our condensed consolidated balance sheet.

Included within our accounts receivable balance at March 31, 2010 are $2.1 million in receivables, which represent amounts due from dialysis organizations to whom we shipped Feraheme under the 2009 Launch Incentive Program. These shipments were made under agreements which provided these customers with an opportunity to purchase Feraheme through September 30, 2009 at discounted pricing and further provided for extended payment terms and expanded rights of return. As of March 31, 2010, we have a remaining balance of $8.3 million in deferred revenues related to product purchased under the Launch Incentive Program which remained held by the dialysis organizations at March 31, 2010, net of any applicable discounts and estimated rebates.

As part of our credit management policy, we perform ongoing credit evaluations of our customers and we have not required collateral from any customer. To date, we have not experienced significant bad debts. Accordingly, we have not established an allowance for doubtful accounts at either March 31, 2010 or December 31, 2009. If the financial condition of any of our significant customers was to deteriorate and result in an impairment of their ability to make payments owed to us, an allowance for doubtful accounts may be required which could have a material affect on earnings in the period of any such adjustment. Customers which represented greater than 10% of our accounts receivable balance at March 31, 2010 and December 31, 2009 were as follows:

	March 31, 2010		December 31, 2009
Metro Medical Supply, Inc.	34	%	20	%
AmerisourceBergen Drug Corporation	30	%	29	%
Dialysis Clinics, Inc.	14	%	15	%
Liberty Dialysis, LLC	—		10	%
Satellite Healthcare, Inc.*	—		10	%

* During 2009, our Chief Executive Officer was a member of the Board of Directors of Satellite Healthcare, Inc. but resigned from that position during the three months ended March 31, 2010.

E. Inventories

Our major classes of inventories were as follows at March 31, 2010 and December 31, 2009 (in thousands):

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	March 31, 2010		December 31, 2009

Raw materials	$	1,496	$	1,584
Work in process	1,678		1,169
Finished goods	8,620		6,326
Finished goods held by others	247		336
Total inventories	$	12,041	$	9,415

Finished goods inventory held by others primarily relates to inventories held by dialysis organizations to which we have shipped Feraheme under the Launch Incentive Program. Agreements entered into under this program provided certain customers with extended payment terms and expanded rights of return. As a result, in accordance with current accounting and reporting standards related to revenue recognition, we have deferred both the recognition of revenues and the costs of the inventory sold under this program and presented inventories held by others as a separate component of our overall inventory as of March 31, 2010 and December 31, 2009.

Equity-based compensation of $0.2 million was capitalized into inventory for the three months ended March 31, 2010. There was no equity-based compensation capitalized into inventory for the three months ended March 31, 2009.

F. Property, Plant and Equipment

Property, plant and equipment consisted of the following at March 31, 2010 and December 31, 2009 respectively (in thousands):

	March 31, 2010			December 31, 2009

Land	$	360		$	360
Buildings and improvements	10,892			10,356
Laboratory and production equipment	6,917			6,839
Furniture and fixtures	4,409			4,345
Construction in process	833			1,294
Total property, plant and equipment	23,411			23,194
Less - accumulated depreciation	(11,347		)	(10,777		)
Property, plant and equipment, net	$	12,064		$	12,417

G. Income Taxes

Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax basis of assets and liabilities using future enacted rates. A valuation allowance is recorded against deferred tax assets if it is more likely than not that some or all of the deferred tax assets will not be realized.

For the three months ended March 31, 2010 we did not recognize any tax expense or benefit due to our continued net operating loss position. For the three months ended March 31, 2009, we recognized a current federal income tax benefit of $0.2 million associated with U.S. research and development tax credits against which we had previously provided a full valuation allowance, but which became refundable as a result of

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legislation passed in February 2009. Due to the uncertainty surrounding realization of favorable tax attributes in future tax returns, we have recorded a full valuation allowance against our otherwise recognizable net deferred tax assets.

H. Net Loss per Share

We compute basic net loss per share by dividing net loss by the weighted average number of common shares outstanding during the relevant period. The following table sets forth the potential common shares issuable upon the exercise of outstanding options and the vesting of restricted stock units (prior to consideration of the treasury stock method), the total of which was excluded from our computation of diluted net loss per share because such options and restricted stock units were anti-dilutive due to a net loss in the relevant periods (in thousands):

	Three Months Ended March 31,
	2010	2009
Options to purchase shares of common stock	2,845	2,671
Shares of common stock issuable upon the vesting of restricted stock units	273	217
Total	3,118	2,888

The components of basic and diluted net loss per share were as follows (in thousands, except per share data):

	Three Months Ended March 31,
	2010			2009
Net loss	$	(23,053	)	$	(26,423	)
Weighted average common shares outstanding	19,985			17,021
Net loss per share:
Basic and diluted	$	(1.15	)	$	(1.55	)

I. Equity-Based Compensation

We maintain several equity compensation plans, including our Amended and Restated 2007 Equity Incentive Plan, or the 2007 Plan, our Amended and Restated 2000 Stock Plan, or the 2000 Plan, and our 2006 Employee Stock Purchase Plan.

2007 Plan

As of March 31, 2010, we have granted options and restricted stock units covering 2,720,575 shares of common stock under our 2007 Plan, of which 321,013 stock options and 10,000 restricted stock units have expired or terminated, and of which 23,766 options have been exercised and 1,250 shares of common stock were issued pursuant to restricted stock units that became fully vested. The number of options and restricted stock units outstanding under this plan as of March 31, 2010 was 2,103,715 and 260,831, respectively. The remaining number of shares available for future grants as of March 31, 2010 was 395,023, not including shares subject to outstanding awards under the 2000 Plan, which will be added to the total number of shares available for issuance under the 2007 Plan to the extent that such awards expire or terminate for any reason prior to exercise. All outstanding options granted under our

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2007 Plan have an exercise price equal to the closing price of our common stock on the grant date and a ten-year term.

2000 Plan

As of March 31, 2010, we have granted options and restricted stock units covering 2,182,700 shares of common stock under the 2000 Plan, of which 402,825 stock options and 750 restricted stock units have expired or terminated, and of which 994,268 stock options have been exercised and 31,000 shares of common stock were issued pursuant to restricted stock units that became fully vested. The remaining number of shares underlying outstanding options and restricted stock units pursuant to the 2000 Plan as of March 31, 2010 was 741,607 and 12,250, respectively. All outstanding options granted under the 2000 Plan have an exercise price equal to the closing price of our common stock on the grant date. In November 2007, the 2000 Plan was succeeded by our 2007 Plan and, accordingly, no further grants may be made under this plan. Any shares that remained available for issuance under the 2000 Plan as of the date of adoption of the 2007 Plan are included in the number of shares that may be issued under the 2007 Plan. Any shares subject to outstanding awards granted under the 2000 Plan that expire or terminate for any reason prior to exercise will be added to the total number of shares available for issuance under the 2007 Plan.

Equity-based compensation expense

Equity-based compensation expense, net of amounts capitalized into inventory, was as follows (in thousands):

	Three Months Ended March 31,
	2010		2009
Cost of product sales	$	75	$	—
Research and development	1,205		1,095
Selling, general and administrative	3,021		2,407
Total equity-based compensation expense	$	4,301	$	3,502

Equity-based compensation of $0.2 million was capitalized into inventory for the three months ended March 31, 2010. Capitalized equity-based compensation is recognized into cost of product sales when the related product is sold.

J. Common Stock Transactions

In January 2010, we sold 3.6 million shares of our common stock, $0.01 par value per share, in an underwritten public offering at a price to the public of $48.25 per share, resulting in gross proceeds of approximately $173.7 million. Net proceeds to us after deducting fees, commissions and other expenses related to the offering were approximately $165.6 million. The shares were issued pursuant to a shelf registration statement on Form S-3 which became effective upon filing.

K. Commitments and Contingencies

Legal Proceedings

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al. , Civil Action No. 1:10-CV-10470-NMG. The complaint alleges that the defendants violated the federal securities laws, specifically Section 11 of the Securities Act of 1933, as amended, by making certain alleged false and misleading statements and omissions in a registration statement filed in January 2010. The plaintiff seeks unspecified damages on behalf of a purported class of purchasers of our common stock pursuant to our common stock offering on or about January 21, 2010. No trial date has been scheduled. We believe that the allegations contained in the complaint are without merit and intend to defend the case vigorously. We have not recorded an estimated liability associated with this legal proceeding as we do not believe that such a liability is probable or estimable.

We may periodically become subject to legal proceedings and claims arising in connection with on-going business activities, including claims or disputes related to patents that have been issued or that are pending in the field of research on which we are focused. Other than the complaint described above, we are not aware of any material claims against us at March 31, 2010.

L. Collaborative Agreements

On March 31, 2010, we entered into a License, Development and Commercialization Agreement, or the Takeda Agreement, with Takeda Pharmaceutical Company Limited, or Takeda. Under the Takeda Agreement, we granted exclusive rights to Takeda to develop and commercialize Feraheme as a therapeutic agent in Europe, Asia-Pacific countries (excluding Japan, China and Taiwan), the Commonwealth of Independent States, Canada, India and Turkey, or collectively, the Licensed Territory. As provided for under the Takeda Agreement, except under limited circumstances, we have retained the right to manufacture Feraheme and, accordingly, are responsible for supply of the product to Takeda. We are also responsible for conducting, and bearing the costs related to, certain predefined clinical studies with the costs of future modifications or additional studies to be allocated between the parties according to an agreed upon cost-sharing mechanism, which provides for a cap on such costs. We will receive a combination of upfront, regulatory approval and performance-based milestone payments, as well as defined payments for supply of the drug product and royalties on net product sales by Takeda in the Licensed Territory. The milestone payments may total over time up to approximately $220.0 million, primarily dependent upon regulatory approvals and the attainment of specified annual sales levels. In accordance with the terms of the Takeda Agreement, in April 2010 we received a $60.0 million upfront payment from Takeda which we have recorded as a receivable from collaboration in our condensed consolidated balance sheet as of March 31, 2010. We will recognize the upfront payment into revenues on a straight-line basis over ten years, which is our best estimate of the period over which we will perform our obligations under the Takeda Agreement. In addition, we are eligible to receive tiered double-digit royalties on net sales of Feraheme in the Licensed Territory. As of March 31, 2010, we have not recognized any significant revenues under the Takeda Agreement. In October 2009, the Financial Accounting Standards Board, or FASB, issued Accounting Standard Update, or ASU, No. 2009-13, Multiple-Deliverable Revenue Arrangements, or ASU 2009-13. ASU 2009-13 amends existing revenue recognition accounting pronouncements. We are currently evaluating the potential impact of this standard on our condensed consolidated financial statements, specifically with respect to our accounting and disclosures related to the Takeda collaboration.

In 2008, we entered into Collaboration and Exclusive License Agreement, or the 3SBio License Agreement, and a Supply Agreement, or the 3SBio Supply Agreement, with 3SBio Inc., or 3SBio, with respect to the development and commercialization of Feraheme as an IV iron replacement therapeutic agent in China. The 3SBio License Agreement grants 3SBio an exclusive license for an initial term of thirteen years to develop and commercialize Feraheme as a therapeutic agent in China for an initial indication for the treatment of IDA in patients with CKD, and an option to expand into additional therapeutic indications. In consideration of the grant of the license, we received an upfront payment of $1

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million, the recognition of which has been deferred and is being recognized under the proportional performance methodology as we supply Feraheme to 3SBio over the thirteen year initial term of the agreement. We are eligible to receive certain other specified milestone payments upon regulatory approval of Feraheme in China for CKD and other indications. We are also entitled to receive tiered royalties of up to 25% based on sales of Feraheme by 3SBio in China. We retained all manufacturing rights for Feraheme . In addition, pursuant to the 3SBio Supply Agreement, 3SBio has agreed to purchase from us, and we have agreed to supply to 3SBio, Feraheme at a predetermined supply price for clinical and commercial use in connection with 3SBio’s development and commercialization obligations described above for so long as the 3SBio License Agreement is in effect. To date we have not provided 3SBio with any product under the 3SBio Supply Agreement.

M. Recently Issued and Proposed Accounting Pronouncements

In February 2010, the FASB issued ASU No. 2010-09, Subsequent Events: Amendments to Certain Recognition and Disclosure Requirements, or ASU 2010-09, which amends Accounting Standards Codification, or ASC, 855 to address certain implementation issues related to an entity’s requirement to perform and disclose subsequent events procedures. The amendments in ASU 2010-09 remove the requirement for an SEC filer to disclose a date through which subsequent events have been evaluated in both issued and revised financial statements. We adopted this guidance as of its issuance date and because this guidance only amends required disclosures in our condensed consolidated financial statements, it did not have an effect upon our financial position or results of operations.

In January 2010, the FASB issued ASU No. 2010-06, Improving Disclosures About Fair Value Measurements, or ASU 2010-06, which also amends ASC 820. ASU 2010-06 requires additional disclosure related to transfers in and out of Levels 1 and 2 and the activity in Level 3. This guidance requires a reporting entity to disclose separately the amounts of significant transfers in and out of Level 1 and Level 2 fair value measurements and describe the reasons for the transfers. In addition, this guidance requires a reporting entity to present separately information about purchases, sales issuances, and settlements in the reconciliation for fair value measurements using significant unobservable inputs (Level 3). This accounting standard was effective for interim and annual reporting periods beginning after December 31, 2009 other than for disclosures about purchases, sales, issuances and settlements in the roll forward of activity in Level 3 fair value measurements. Those disclosures will be effective for fiscal years beginning after December 31, 2010 and for interim periods within those fiscal years. We adopted all provisions of this pronouncement, except for those related to the disclosure of disaggregated Level 3 activity, during the first quarter of 2010 and because this guidance only amends required disclosures in our condensed consolidated financial statements, it did not have an effect upon our financial position or results of operations. We do not expect the adoption of the remaining provisions of this amendment to have a significant impact on our consolidated financial statements.

In October 2009, the FASB issued ASU No. 2009-13. ASU 2009-13 amends existing revenue recognition accounting pronouncements that are currently within the scope of FASB ASC Subtopic 605-25 (previously included within Emerging Issues Task Force, or EITF, No. 00-21, Revenue Arrangements with Multiple Deliverables, or EITF 00-21). The consensus to EITF Issue No. 08-1, Revenue Arrangements with Multiple Deliverables, or EITF 08-1, provides accounting principles and application guidance on whether multiple deliverables exist, how the arrangement should be separated, and the consideration allocated. This guidance eliminates the requirement to establish the fair value of undelivered products and services and instead provides for separate revenue recognition based upon management’s estimate of the selling price for an undelivered item when there is no other means to determine the fair value of that undelivered item. EITF 00-21 previously required that the fair value of the undelivered item be the price of the item either sold in a separate transaction between unrelated third parties or the price charged for each item when the item is sold separately by the vendor. This was

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difficult to determine when the product was not individually sold because of its unique features. Under EITF 00-21, if the fair value of all of the elements in the arrangement was not determinable, then revenue was deferred until all of the items were delivered or fair value was determined. This new approach is effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. Early adoption is permitted; however, adoption of this guidance as of a date other than January 1, 2011 will require us to apply this guidance retrospectively to January 1, 2010 and will require disclosure of the effect of this guidance as applied to all previously reported interim periods in the fiscal year of adoption. We are currently evaluating the potential impact of this standard on our condensed consolidated financial statements, specifically with respect to our accounting and disclosures related to the Takeda collaboration.

In December 2009, the FASB issued ASU No. 2009-16, Accounting for Transfers of Financial Assets, or ASU 2009-16. ASU 2009-16 relates to the accounting and disclosure requirements related to the servicing and transfer of financial assets. ASU 2009-16 enhances information reported to users of financial statements by providing greater transparency about transfers of financial assets and an entity’s continuing involvement in transferred financial assets, including securitization transactions, where entities have continuing exposure to the risks related to transferred financial assets. It eliminates the concept of a “qualifying special-purpose entity,” changes the requirements for de-recognizing financial assets, and requires additional disclosures. This amendment is effective for fiscal years beginning after November 15, 2009. We adopted this pronouncement during the first quarter of 2010 which did not have a significant impact on our condensed consolidated financial statements.

In December 2009, the FASB issued ASU No. 2009-17, Improvements to Financial Reporting by Enterprises Involved with Variable Interest Entities, or ASU 2009-17. ASU 2009-17 relates to the accounting and disclosure requirements related to the consolidation of variable interest entities and changes how a reporting entity determines when an entity that is insufficiently capitalized or is not controlled through voting (or similar rights) should be consolidated. The determination of whether a reporting entity is required to consolidate another entity is based on, among other things, the other entity’s purpose and design and the reporting entity’s ability to direct the activities of the other entity that most significantly impact the other entity’s economic performance. The reporting entity will be required to provide additional disclosures about its involvement and will be required to disclose how its involvement with a variable interest entity affects the reporting entity’s financial statements. This amendment is effective for fiscal years beginning after November 15, 2009. We adopted this pronouncement during the first quarter of 2010 which did not have a significant impact on our condensed consolidated financial statements.

Item 2. Management’s Discussion And Analysis Of Financial Condition And Results Of Operations.

The following information should be read in conjunction with the unaudited financial information and the notes thereto included in this Quarterly Report on Form 10-Q and the audited financial information and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2009.

Except for the historical information contained herein, the matters discussed in this Quarterly Report on Form 10-Q may be deemed to be forward-looking statements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. In this Quarterly Report on Form 10-Q, words such as “may,” “will,” “expect,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this report include statements regarding the following: our expectations regarding our intended development and commercialization of

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Feraheme ® (ferumoxytol) Injection, our expectations regarding the success of our collaboration with Takeda Pharmaceutical Company Limited, the expected timing of the filing of our Marketing Authorization Application for Feraheme with the European Medicines Agency, our plan to conduct four pediatric studies and the expected timing and design of these studies, our plan to conduct and the intended timing and design of our planned global studies of Feraheme for the treatment of iron deficiency anemia in a broad range of patients, our plan to complete our Phase II study of Feraheme in vascular-enhanced magnetic resonance imaging later in 2010, our statement that our partner in China, 3SBio Inc., plans to conduct a Feraheme clinical study in China, our expectation that sales of GastroMARK will not change materially, our expectation regarding our future revenues, including expected Feraheme, Takeda Pharmaceutical Company Limited and 3SBio Inc. revenues and our expectation to partly fund our future operations with Feraheme revenues, our expectation that our reserves as a percentage of gross sales will increase during the remainder of 2010, our expectation regarding milestone payments we may receive from Takeda Pharmaceutical Company Limited, our expectation that during 2010 and into the future our net sales as a percentage of gross sales will be negatively affected as a result of recently enacted healthcare legislation, our expectation that our costs of product sales will increase, our expectation regarding our research and development expenses for the remainder of 2010, our expectations regarding the amount of external expenses and the timing of our planned research and development projects, our expectation regarding our selling, general and administrative expenses for the remainder of 2010, our expectation regarding our dividend and interest income, our expectations regarding our short- and long-term liquidity and capital requirements and our ability to finance our operations, our expectation regarding our future cash flows, our belief that the decline in the value of our auction rate securities not subject to settlement right agreements is temporary and that we will ultimately be able to liquidate these investments without significant loss, our intention to sell our auction rate securities subject to settlement right agreements to UBS AG, our belief that the allegations asserted against us in the class action lawsuit are without merit, and information with respect to any other plans and strategies for our business. Our actual results and the timing of certain events may differ materially from the results discussed, projected, anticipated or indicated in any forward-looking statements. Any forward-looking statement should be considered in light of the factors discussed in this Quarterly Report on Form 10-Q. We caution readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. We disclaim any obligation, except as specifically required by law and the rules of the United States Securities and Exchange Commission to publicly update or revise any such statements to reflect any change in company expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Overview

On June 30, 2009, Feraheme was approved for marketing in the U.S. by the U.S. Food and Drug Administration, or the FDA, for use as an IV iron replacement therapy for the treatment of IDA in adult patients with chronic kidney disease, or CKD. We market and sell Feraheme through our own commercial organization, including a specialized sales force and account management and reimbursement teams. We sell Feraheme primarily to authorized wholesalers and specialty distributors and began commercial sale of Feraheme in the U.S. in July 2009.

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For the three months ended March 31, 2010, we recognized net product sales of Feraheme of $13.1 million, including approximately $2.2 million of previously deferred product revenues. During the third quarter of 2009, shortly after the launch of Feraheme , we implemented a Launch Incentive Program under which certain dialysis organizations purchased Feraheme directly from us. This program provided certain customers with, among other things, discounted pricing and expanded rights of return. As a result, we deferred revenues associated with this program which we recognize as revenues as the participating organizations utilize their Feraheme inventory.

In December 2009, we submitted draft protocols for two proposed clinical trials to meet our FDA post-approval Pediatric Research Equity Act requirement to support pediatric labeling of Feraheme. In 2010, we intend to initiate these two randomized, active controlled pediatric studies in children with CKD and IDA. One study will be in dialysis dependent CKD patients, and the other will be in CKD patients not on dialysis. Each study will assess the safety and efficacy of Feraheme treatment as compared to oral iron in approximately 144 children.

We also plan to advance our Feraheme clinical development program in adults by initiating two Phase III multi-center clinical trials in mid-2010 to assess Feraheme for the treatment of IDA in a broad range of patients, which may include women with abnormal uterine bleeding, or AUB, patients with cancer and gastrointestinal diseases and postpartum women, for whom oral iron is unsatisfactory. One study will assess the efficacy and safety of two doses of 510 milligrams each of Feraheme compared to placebo in a total of approximately 800 patients with IDA. A second study will assess the efficacy and safety of two doses of 510 milligrams each of Feraheme compared to a total dose of 1,000 milligrams of an IV iron sucrose product in a total of approximately 600 patients with IDA. Further, we intend to initiate an open label extension study enrolling patients from the placebo controlled study who will be followed for six months and will be eligible to receive two doses of 510 milligrams each of Feraheme whenever they meet treatment criteria.

In connection with our responsibilities under the Takeda Agreement, we expect to file a Marketing Authorization Application, or MAA, in mid-2010 for Feraheme for the treatment of IDA in CKD patients with the European Medicines Agency, or EMA. In the fourth quarter of 2009, we received approval from the EMA for our Pediatric Investigation Plan, which is a prerequisite for the submission of our Feraheme MAA. Our Pediatric Investigation Plan includes the two pediatric studies required to meet our Pediatric Research Equity Act requirement and two additional pediatric studies requested by the EMA. To further support our MAA, we have initiated a global, randomized, Phase IV multi-center, active controlled trial with approximately 150 adult CKD patients both on dialysis and not on dialysis. This study will assess the safety and efficacy of two doses of 510 milligrams each of Feraheme compared to a total dose of 1,000 milligrams of an IV iron sucrose product.

In addition, as part of our obligation under the Takeda Agreement, we are planning to advance our Feraheme clinical development program in adult patients with CKD by initiating a Phase IV multi-center

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clinical trial. This study will assess the safety and efficacy of repeat, episodic Feraheme administration for the treatment of persistent or recurrent IDA over a 12 month period. Subjects will receive an initial course of two doses of 510 milligrams each of Feraheme , and will receive subsequent courses of two doses of 510 milligrams of Feraheme whenever they meet treatment criteria. The study is expected to enroll a total of approximately 300 CKD patients with IDA including patients on dialysis (hemodialysis or peritoneal dialysis) and those not on dialysis, including post-kidney transplant recipients.

In December 2009, we filed a New Drug Submission for Feraheme to treat IDA in patients with CKD with the Therapeutic Products Directorate of Health Canada, the federal authority that regulates pharmaceutical drugs and medical devices for human use in Canada. This filing has been accepted and is currently under review. In addition, in December 2009, our partner in China, 3SBio Inc., or 3SBio, filed an application with the Chinese State Food and Drug Administration, or the SFDA, to obtain approval to begin a registrational clinical trial necessary to file for marketing approval in China. Once approved by the SFDA, 3SBio plans to commence a multi-center randomized efficacy and safety study in China involving approximately 200 CKD patients.

In addition to its use for the treatment of IDA, Feraheme may also be useful as a vascular enhancing agent in magnetic resonance imaging, or MRI. The FDA has granted Fast Track designation to Feraheme with respect to its development as a diagnostic agent for vascular-enhanced MRI for the assessment of peripheral arterial disease, or PAD, in patients with known or suspected CKD. We have enrolled over 90% of our 108 patient Phase II study of Feraheme in vascular-enhanced MRI for the detection of clinically significant arterial stenosis or occlusion, or the narrowing or blocking of arteries. We plan to complete the Phase II study later this year and will assess next steps for development based on the Phase II data.

GastroMARK , our oral contrast agent used for delineating the bowel in MRI, is approved and marketed in the U.S., Europe, and other countries through our marketing partners. Sales of GastroMARK by our marketing partners have been at their current levels for the last several years, and we do not expect sales of GastroMARK to change materially.

In the past, we have devoted substantially all of our resources to our research and development programs and, more recently, we have also incurred substantial costs related to the commercialization of Feraheme . Prior to the commercial launch of Feraheme , we financed our operations primarily from the sale of our equity securities, cash generated by our investing activities, and payments from our strategic partners. At March 31, 2010, our accumulated deficit was approximately $304.7 million. We expect to continue to incur significant expenses to manufacture, market and sell Feraheme as an iron replacement therapeutic in CKD patients in the U.S. and to further develop Feraheme for additional indications and in additional countries outside of the U.S. In the second half of 2009, we began to derive revenues from product sales of Feraheme . We currently expect to fund our future operations in part from the sale of Feraheme in addition to the sale of our equity securities, cash generated by our investing activities, and payments from our strategic partners.

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Results of Operations for the Three Months Ended March 31, 2010 as Compared to the Three Months Ended March 31, 2009

Revenues

Total revenues were $13.3 million and $1.0 million for the three months ended March 31, 2010 and 2009, respectively, representing an increase of approximately $12.3 million, or greater than 100%. The increase in revenues was primarily due to product sales of Feraheme following its FDA approval and commercial launch in mid-2009.

The following table sets forth customers who represented 10% or more of our revenues for the three months ended March 31, 2010 and 2009. No other company accounted for more than 10% of our total revenues for the three months ended March 31, 2010 and 2009.

	Three Months Ended March 31,
	2010		2009
Metro Medical Supply, Inc.	36	%	—
AmerisourceBergen Drug Corporation	29	%	—
Guerbet S.A.	< 10	%	33	%
Covidien, Ltd.	< 10	%	13	%
Bayer Healthcare Pharmaceuticals	—		54	%

Our revenues for the three months ended March 31, 2010 and 2009 consisted of the following (in thousands):

	Three Months Ended March 31,
	2010		2009		$ Change			% Change
Product sales, net	$	13,295	$	393	$	12,902		>100	%
License fees	—		516		(516		)	-100	%
Royalties	11		47		(36		)	-77	%
Total	$	13,306	$	956	$	12,350		>100	%

Net Product Sales

Net product sales for the three months ended March 31, 2010 and 2009 consisted of the following (in thousands):

	Three Months Ended March 31,
	2010		2009		$ Change			% Change
Feraheme	$	13,056	$	—	$	13,056		N/A
GastroMARK	239		393		(154		)	-39	%
Total	$	13,295	$	393	$	12,902		>100	%

The $12.9 million, or greater than 100%, increase in net product sales was primarily due to the FDA approval and subsequent U.S. commercial launch of Feraheme in mid-2009 . Included in Feraheme product sales is $2.2 million of product sales related to previously deferred revenues recorded under our Launch Incentive Program .

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Our product sales may fluctuate from period to period as a result of factors such as wholesaler demand forecasts and buying decisions as well as end user demand, which can create uneven purchasing patterns by our customers. Our product sales may also fluctuate as the result of changes or adjustments to our reserves or changes in government or customer rebates. For example, in March 2010, U.S. healthcare reform legislation was enacted which contains several provisions that impact our business. Although many provisions of the new legislation do not take effect immediately, several provisions became effective in the first quarter of 2010, including the following:

· an increase in the minimum statutory Medicaid rebate to states participating in the Medicaid program from 15.1% to 23.1%;

· an extension of the Medicaid rebate to drugs dispensed to Medicaid beneficiaries enrolled with managed care organizations; and

· an expansion of the 340(B) Public Health Services drug pricing program, which provides drugs at reduced rates, to include additional hospitals, clinics, and healthcare centers in an outpatient setting.

Beginning in 2011, we may incur our share of a new fee assessed on all branded prescription drug manufacturers and importers. This fee will be calculated based upon Feraheme’s percentage share of total branded prescription drug sales to U.S. government programs (such as Medicare, Medicaid and VA and PHS discount programs) made during the previous year. The aggregated industry wide fee is expected to total $28 billion through 2019, ranging from $2.5 billion to $4.1 billion annually. Presently, uncertainty exists as many of the specific determinations necessary to implement this new legislation have yet to be decided and communicated to industry participants. For example, determinations as to how the annual fee on branded prescription drugs will be calculated and allocated remain to be clarified, though, as noted above, this provision will not be effective until 2011.

We expect that during 2010 and into the future, our net sales as a percentage of gross sales will be negatively affected as a result of certain aspects of the recently enacted healthcare legislation, specifically, the increase in the minimum Medicaid rebates and the expansion to whom the rebates may potentially apply. It is possible that the effect of this legislation could further adversely impact our future revenues, however, we are still assessing the full extent of this legislation’s future impact on our business.

· persuasive evidence of an arrangement exists;

· delivery of product has occurred or services have been rendered;

· the sales price charged is fixed or determinable; and

· collection is reasonably assured.

We record product sales allowances and accruals related to prompt payment discounts, chargebacks, governmental and other rebates, distributor, wholesaler and group purchasing organization, or GPO, fees, and product returns as a reduction of revenue in our condensed consolidated statement of operations at the time product sales are recorded. Calculating these gross-to-net sales adjustments involves estimates and judgments based primarily on actual Feraheme sales data, forecasted customer buying patterns blended with historical experience of products similar to Feraheme sold by others, and other market research. In addition,

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we also monitor our distribution channel to determine the level of additional allowances or accruals required based on inventory in our sales channel. There were no product sales allowances or accruals for the three months ended March 31, 2009. For further details related to our revenue recognition and related sales allowances policy refer to our critical accounting policies included in Part II, Item 7 “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our Annual Report on Form 10-K for the year ended December 31, 2009.

An analysis of our product sales allowances and accruals for the three months ended March 31, 2010 is as follows (in thousands):

	March 31, 2010
Product sales allowances and accruals:
Discounts and chargebacks	$	742
Government and other rebates	3,001
Returns	244
Total product sales allowances and accruals	$	3,987

Total net product sales	$	13,295

Total gross product sales	$	17,282

Total product sales allowances and accruals as a percent of total gross product sales	23		%

An analysis of the amount of, and change in, reserves for the three months ended March 31, 2010 is as follows (in thousands):

	Discounts			Rebates and Fees			Returns			Total
Balance at January 1, 2010	$	499		$	5,194		$	463		$	6,156
Current provisions relating to sales in current year	742			3,284			294			4,320
Other provisions relating to deferred revenue	—			(383		)	—			(383		)
Adjustments relating to sales in prior year	—			(283		)	(50		)	(333		)
Payments/returns relating to sales in current year	(158		)	(34		)	—			(192		)
Payments/returns relating to sales in prior year	(495		)	(2,105		)	—			(2,600		)
Balance at March 31, 2010	$	588		$	5,673		$	707		$	6,968

Product sales allowances and accruals are primarily comprised of both direct and indirect fees, discounts and rebates. Direct fees, discounts and rebates are contractual fees and price adjustments payable to wholesalers, specialty distributors and other customers that purchase products directly from us. Indirect fees, discounts and rebates are contractual price adjustments payable to healthcare providers and organizations, such as certain dialysis organizations, physicians, clinics, hospitals, and GPOs that typically do not purchase products directly from us but rather from wholesalers and specialty distributors. In accordance with guidance related to accounting for fees and consideration given by a vendor to a customer (including a reseller of a vendor’s products), these fees, discounts and rebates are presumed to be a reduction of the selling price of Feraheme . Product sales allowances and accruals are based on definitive contractual agreements or legal requirements (such as Medicaid laws and regulations) related to the purchase and/or utilization of the product by these entities. Allowances and accruals are generally recorded in the same period that the related revenue is recognized and are estimated using either historical, actual and/or other data, including estimated patient

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usage, applicable contractual rebate rates, contract performance by the benefit providers, other current contractual and statutory requirements, historical market data based upon experience of other similar products to Feraheme , specific known market events and trends such as competitive pricing and new product introductions and current and forecasted customer buying patterns and inventory levels, including the shelf life of our products. As part of this evaluation, we also review changes to federal legislation, changes to rebate contracts, changes in the level of discounts, and changes in product sales trends. Reserve estimates are evaluated quarterly and may require adjustments to better align our estimates with actual results. During the three months ended March 31, 2010, our allowances for government and other rebates reflected a reduction in prior year Medicaid allowances which was primarily the result of a reduction in our estimates of Medicaid utilization across Feraheme customer classes resulting from additional data, including information regarding Medicaid claims experience for comparable products. This reduction was partially offset by an increase in estimated Medicaid allowances associated with the increase in statutory minimum rebate rates included in the legislation described above. Although allowances and accruals are recorded at the time of product sale, certain rebates are typically paid out, on average, up to six months or longer after the sale. If actual future results vary from our estimates, we may need to adjust our previous estimates, which would affect our earnings in the period of the adjustment.

There are several factors that make it difficult to predict future changes in our sales allowances and accruals as a percentage of gross product sales including, but not limited to, the following:

· variations in, and the success of, fee, rebate and discount structures implemented in our efforts to increase adoption of Feraheme ;

· variations in our future customer mix;

· changes in legislation, such as the healthcare legislation discussed above;

· the percentage of total revenues in each period which are the result of utilization by customers who purchased Feraheme directly from us at the discounted pricing under our Launch Incentive Program; and

· adjustments and refinements to prior estimates and assumptions.

Overall, we expect that our reserves as a percent of gross sales will increase during the remainder of 2010 due primarily to our efforts to increase adoption and utilization of Feraheme , the increase in statutory minimum rebate rates noted above as well as customer mix assumptions, which will negatively affect our future net product sales.

Because we only recently launched Feraheme in the U.S. there are a number of factors that make it particularly difficult to predict the magnitude of future Feraheme sales, including the magnitude and timing of adoption of Feraheme by physicians, dialysis clinics, hospitals and other healthcare payors and providers, the inventory levels maintained by Feraheme wholesalers, distributors and other customers, the frequency of re-orders by existing customers, and the pricing of products that compete with Feraheme and other actions taken by our competitors. Accordingly, our Feraheme net product revenues in previous quarters may not be indicative of future Feraheme net product revenues. As a result of these and other factors, future Feraheme sales could vary significantly from quarter to quarter.

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Deferred Revenue - Launch Incentive Program

During the third quarter of 2009 certain dialysis organizations purchased Feraheme from us under our Launch Incentive Program. These purchases were made under agreements which provided these customers with an opportunity to purchase Feraheme through September 30, 2009 at discounted pricing and further provided for extended payment terms and expanded rights of return. As a result, in accordance with current accounting guidance which requires that we defer recognition of revenues until we can reasonably estimate returns related to those purchases, we have deferred the recognition of revenues associated with these purchases until our customers report to us that such inventory has been utilized in their operations. Any purchases returned to us will not be recorded as revenue . Accordingly, as of March 31, 2010, we have a remaining balance of $8.3 million in deferred revenues, which represents product purchased under the Launch Incentive Program which remained held by the dialysis organizations at March 31, 2010, net of any applicable discounts and estimated rebates, which are included in our commercial rebate accruals as of March 31, 2010. In addition, we have deferred the relat ed cost of product sales of approximately $0.2 million and recorded such amount as finished goods inventory held by others as of March 31, 2010. Because we are unable to reasonably estimate the amount of inventory that may be returned under this program, if any, we cannot provide any assurance that amounts reported as deferred revenue and associated with this program will be utilized by our customers and thereby recorded by us as product revenues in our future condensed consolidated statements of operations.

License Fee and Other Collaboration Revenues

There were no license fee revenues for the three months ended March 31, 2010. The $0.5 million license fee revenues for the three months ended March 31, 2009 consisted solely of deferred revenues that were being amortized in connection with our agreements with Bayer Healthcare Pharmaceuticals, or Bayer, which were terminated in November 2008. In 1995, we entered into a License and Marketing Agreement and a Supply Agreement, or the Bayer Agreements, granting Bayer a product license and exclusive marketing rights to Feridex I.V. ® in the U.S. and Canada. In connection with our decision to cease manufacturing Feridex I.V ., the Bayer Agreements were terminated in November 2008 by mutual agreement. Prior to the termination of the Bayer Agreements, we accounted for the revenues associated with the Bayer Agreements on a straight line basis over their 15 year contract term. Pursuant to the termination agreement, Bayer continued to sell any remaining Feridex I.V. inventory in its possession through April 1, 2009. As a result of the termination of these agreements, during the three months ended March 31, 2009 we recognized the remaining $0.5 million of deferred revenues under the Bayer Agreements. No further significant obligation exists by either party.

On March 31, 2010, we entered into the Takeda Agreement. Under the Takeda Agreement, we granted exclusive rights to Takeda to develop and commercialize Feraheme as a therapeutic agent in the Licensed Territory. As provided for under the Takeda Agreement, except under limited circumstances, we have retained the right to manufacture Feraheme and, accordingly, are responsible for supply of the product to Takeda. We are also responsible for conducting, and bearing the costs related to, certain predefined clinical studies with the costs of future modifications or additional studies to be allocated between the parties according to an agreed upon cost-sharing mechanism, which provides for a cap on such costs. We will receive a combination of upfront, regulatory approval and performance-based milestone payments, as well as defined payments for supply of the drug product and royalties on net product sales by Takeda in the Licensed Territory. The milestone payments may total over time up to approximately $220.0 million, primarily dependent upon regulatory approvals and the attainment of specified annual sales levels. In accordance with the terms of the Takeda Agreement, in April 2010 we received a $60.0 million upfront payment from Takeda which we will recognize into revenues on a straight-line basis over ten years, which is our best estimate of the period over which we will perform our obligations under the Takeda Agreement. In addition, we are eligible to receive tiered double-digit royalties on net sales of Feraheme in the Licensed Territory. As of March 31, 2010, we have not recognized any significant

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revenues under the Takeda Agreement and have recorded $6.0 million as short-term deferred revenue representing the amount of fees that will be amortized into revenues over the next twelve months. In October 2009, the Financial Accounting Standards Board, or FASB, issued Accounting Standard Update, or ASU, No. 2009-13, Multiple-Deliverable Revenue Arrangements, or ASU 2009-13. ASU 2009-13 amends existing revenue recognition accounting pronouncements. We are currently evaluating the potential impact of this standard on our condensed consolidated financial statements, specifically with respect to our accounting and disclosures related to the Takeda collaboration.

In May 2008, we entered into a Collaboration and Exclusive License Agreement with 3SBio with respect to the development and commercialization of Feraheme as an IV iron replacement therapeutic agent in China. In consideration of the grant of the license, we received an upfront payment of $1 million, the recognition of which has been deferred and is being recognized under the proportional performance methodology as we supply Feraheme to 3SBio over the thirteen year initial term of the agreement. We do not expect license revenues under our agreement with 3SBio to be significant in 2010.

Costs and Expenses

Cost of Product Sales

We incurred costs of $1.0 million and less than $0.1 million associated with product sales, or 8% and 16% of net product sales, during the three months ended March 31, 2010 and 2009, respectively. Our cost of product sales for the three months ended March 31, 2010 was comprised primarily of manufacturing costs associated with Feraheme . Based on our policy to expense costs associated with the manufacture of our products prior to regulatory approval, certain of the costs of Feraheme sold during the three months ended March 31, 2010 were expensed prior to the June 2009 FDA approval, and therefore are not included in the cost of product sales during this period. We continue to hold Feraheme inventory that has been previously expensed, and once such inventory has been fully depleted, we expect our cost of product sales as a percentage of net product sales will increase, reflecting the full manufacturing cost of our inventory. We cannot predict when such previously expensed materials will be exhausted, as this will be dependent on the timing and magnitude of Feraheme sales in the U.S. We also anticipate that costs of product sales will increase as sales volume increases.

In addition, as of March 31, 2010, we deferred approximately $0.2 million of costs associated with product sales made under our Launch Incentive Program. These costs have been recorded as finished goods inventory held by others on our condensed consolidated balance sheet as of March 31, 2010. We recognize the cost of product sold under the Launch Incentive Program as, and to the extent that, inventory is utilized by our customers.

Research and Development Expenses

Research and development expenses include external expenses, such as costs of clinical trials, contract research and development expenses, certain manufacturing research and development costs, consulting and professional fees and expenses, and internal expenses, such as compensation of employees engaged in research and development activities, the manufacture of product needed to support research and development efforts, related costs of facilities, and other general costs related to research and development. As discussed below, where possible, we track our external costs by major project. To the extent that external costs are not attributable to a specific project or activity, they are included in other external costs. Prior to the June 2009 regulatory approval of Feraheme , costs associated with manufacturing process development and the manufacture of the drug product were recorded as research

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and development expenses. Subsequent to FDA approval, costs associated with the manufacture of Feraheme to be made commercially available in the U.S. are capitalized.

Research and development expenses for the three months ended March 31, 2010 and 2009 consisted of the following (in thousands):

	Three Months Ended March 31,
	2010		2009		$ Change			% Change
External Research and Development Expenses
Feraheme to treat IDA regardless of the underlying cause	$	1,894	$	—	$	1,894		N/A
Feraheme to treat IDA in CKD patients	1,989		—		1,989			N/A
Feraheme as a therapeutic agent in AUB patients	—		1,287		(1,287		)	-100	%
Feraheme as a therapeutic agent, general	293		1,425		(1,132		)	-79	%
Feraheme as an imaging agent in PAD patients	582		323		259			80	%
Feraheme manufacturing and materials	1,637		1,154		483			42	%
Other external costs	327		216		111			51	%
Total	$	6,722	$	4,405	$	2,317		53	%

Internal Research and Development Expenses
Compensation, payroll taxes, benefits and other expenses	4,441		5,572		(1,131		)	-20	%
Equity-based compensation expense	1,205		1,095		110			10	%
Total	$	5,646	$	6,667	$	(1,021	)	-15	%

Total Research and Development Expenses	$	12,368	$	11,072	$	1,296		12	%

Total research and development expenses incurred in the three months ended March 31, 2010 amounted to $12.4 million, an increase of $1.3 million, or 12%, from the three months ended March 31, 2009. The $1.3 million increase reflects the costs incurred as we prepared and initiated new clinical trials and increased spending on ongoing clinical trials. The increase in total research and development expenses was partially offset by a reduction in costs associated with our then planned AUB trial, a reduction in expense related to the manufacture of Feraheme prior to approval for commercial sale, and a reduction in pre-approval costs incurred in the first quarter of 2009 to ready our manufacturing capabilities at our Cambridge, Massachusetts manufacturing facility.

Our external research and development expenses increased by $2.3 million, or 53%, for the three months ended March 31, 2010 as compared to the three months ended March 31, 2009. The increase in our external expenses was due primarily to costs incurred as we began preparations for our Phase III clinical development program for Feraheme to treat IDA regardless of the underlying cause, which we plan to initiate in mid-2010, costs associated with the initiation of a global clinical study to support our MAA in Europe for the treatment of IDA in CKD patients, costs incurred as we progressed our Phase II study of Feraheme as a diagnostic agent for vascular-enhanced MRI for the assessment of PAD, and costs associated with research and development for new manufacturing processes. These increased external research and development expenses were partially offset by a reduction of costs associated with our AUB trial, which was discontinued in 2009, a reduction in costs incurred in connection with our efforts to address the manufacturing observations noted by the FDA during a 2008 inspection of our Cambridge, Massachusetts manufacturing facility and the capitalization to inventory of certain external Feraheme manufacturing and materials costs incurred post FDA approval.

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Our internal research and development expenses decreased by $1.0 million, or 15%, for the three months ended March 31, 2010 as compared to the three months ended March 31, 2009. The decrease in internal costs was due primarily to the allocation of internal manufacturing costs to inventory in the three months ended March 31, 2010, whereas such costs were expensed in the three months ended March 31, 2009 because Feraheme had not been approved for sale by the FDA. At March 31, 2010, we had 57 full-time equivalents, or FTEs, in research and development as compared to 94 FTEs at March 31, 2009, a decrease of 39% due primarily to the reallocation of manufacturing personnel out of research and development following FDA approval of Feraheme in June 2009. The $0.1 million increase in equity-based compensation expense was primarily attributable to increased equity awards to both new and existing employees.

We expect research and development expenses to increase as compared to current levels for the remainder of 2010 primarily as a result of our continued advancement and the initiation of our clinical development programs, including studies and activities required under the Takeda Agreement, as well as other research and development related functions and activities in support of Feraheme . Factors which will impact 2010 research and development expenses include the timing of initiation and pace of enrollment of our pediatric studies of Feraheme , our trial of Feraheme to support our MAA filing with the EMA, our safety and efficacy trial of repeat, episodic Feraheme administration for the treatment of persistent or recurrent IDA, and the design, timing and pace of enrollment of our other clinical trials of Feraheme, including our planned development program for Feraheme in a broad range of patients with IDA.

We do not track our internal costs by project since our research and development personnel work on a number of projects concurrently and much of our fixed costs benefit multiple projects or our operations in general. We track our external costs on a major project by major project basis, in most cases through the later of the completion of the last trial in the project or the last submission of a regulatory filing to the FDA or applicable foreign regulatory body. We have commenced or anticipate commencing the following two major research and development projects during 2010:

· Feraheme to treat IDA regardless of the underlying cause . This project currently includes: (1) a Phase III clinical study evaluating Feraheme treatment compared to treatment with placebo; (2) a second Phase III clinical study evaluating Feraheme treatment compared to treatment with another IV iron; and (3) an extension study.

· Feraheme to treat IDA in CKD patients . This project includes: (1) a clinical study currently underway evaluating Feraheme treatment compared to treatment with another IV iron which will support our planned CKD MAA; (2) two pediatric studies to be conducted as part of our Phase IV Pediatric Research Equity Act requirement to support pediatric CKD labeling of Feraheme ; (3) two additional pediatric studies in accordance with our approved Pediatric Investigation Plan to support our planned CKD MAA; and (4) a Phase IV multi-center clinical trial assessing the safety and efficacy of repeat, episodic Feraheme administration for the treatment of persistent or recurrent IDA over a 12 month period.

During the three months ended March 31, 2010, we incurred aggregate external research and development expenses of approximately $1.9 million related to the development of Feraheme to treat IDA regardless of the underlying cause. We currently estimate that the total external costs associated with the efforts needed to complete this development project will be in the range of approximately $55.0 to $65.0 million over the next several years. This represents a decrease of approximately $15.0 million from our expected range at December 31, 2009, which reflects the finalization of clinical study contracts with

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third-parties as well as actual expenses incurred during the three months ended March 31, 2010 in connection with this project.

During the three months ended March 31, 2010, we incurred aggregate external research and development expenses of approximately $2.0 million related to the development of Feraheme to treat IDA in CKD patients. We currently estimate that the external costs associated with this development project will be in the range of approximately $45.0 to $55.0 million over the next several years. This represents an increase of approximately $15.0 million from our expected range at December 31, 2009, which primarily reflects the addition of a Phase IV multi-center clinical trial assessing the safety and efficacy of repeat, episodic Feraheme administration for the treatment of persistent or recurrent IDA over a 12 month period partially offset by actual expenses incurred during the three months ended March 31, 2010 in connection with this project.

Conducting clinical trials involves a number of uncertainties, many of which are out of our control. Our estimates of external costs associated with our research and development projects could therefore vary from our current estimates for a variety of reasons including but not limited to the following: significant delays in our clinical trials due to slow enrollment, unexpected results from our clinical sites that affect our ability to complete the studies in a timely manner, inadequate performance or errors by third-party service providers, any deficiencies in the design or oversight of these studies by us, the need to conduct additional clinical trials or a delay in the submission of any applicable regulatory filing.

Selling, General and Administrative Expenses

Our selling, general and administrative expenses include costs related to our commercial personnel, including our specialized sales force, medical education professionals, and other commercial support personnel, administrative personnel costs, external and facilities costs required to support the marketing and sale of Feraheme and other costs associated with our corporate-related activities.

Selling, general and administrative expenses for the three months ended March 31, 2010 and 2009 consisted of the following (in thousands):

	Three Months Ended March 31,
	2010		2009		$ Change		% Change
Compensation, payroll taxes and benefits	$	10,052	$	8,421	$	1,631	19	%
Professional and consulting fees and other expenses	10,383		6,922		3,461		50	%
Equity-based compensation expense	3,021		2,407		614		26	%
Total	$	23,456	$	17,750	$	5,706	32	%

The $5.7 million, or 32%, increase in selling, general and administrative expenses for the three months ended March 31, 2010 as compared to the three months ended March 31, 2009 was due primarily to increased costs associated with the expansion of our commercial operations function and our general administrative infrastructure to support our growth as a commercial entity, including compensation and benefits costs related to increased headcount and increased advertising and promotion costs associated with the July 2009 U.S. commercial launch of Feraheme. In addition, during the three months ended March 31, 2010 we incurred legal and other consulting and professional fees in connection with our collaboration with Takeda. At March 31, 2010 we had 179 employees in our selling, general and administrative departments as compared to 171 employees at March 31, 2009, a 5% increase. The $0.6 million increase in equity-based compensation expense was due primarily to increased equity awards to both new and existing employees.

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We expect selling, general and administrative expenses to remain generally consistent with current levels for the remainder of 2010 as we continue our U.S. commercialization efforts related to Feraheme, execute our marketing and promotional programs, and maintain our commercial and administrative infrastructure to support the commercialization of Feraheme .

Other Income (Expense)

Other income (expense) for the three months ended March 31, 2010 and 2009 consisted of the following (in thousands):

	Three Months Ended March 31,
	2010		2009			$ Change			% Change
Interest and dividend income, net	$	471	$	1,256		$	(785	)	-63	%
Gains on investments, net	4		992			(988		)	-100	%
Fair value adjustment of settlement rights	—		(923		)	923			-100	%
Total	$	475	$	1,325		$	(850	)	-64	%

Other income (expense) for the three months ended March 31, 2010 decreased by $0.9 million, or 64%, as compared to the three months ended March 31, 2009. The $0.9 million decrease was primarily attributable to a $0.8 million decrease in interest and dividend income as the result of lower interest rates in the three months ended March 31, 2010 as compared to the three months ended March 31, 2009.

In November 2008, we elected to participate in a rights offering by UBS AG, or UBS, one of our securities brokers, which provided us with the right to sell to UBS $9.3 million in par value of our auction rate securities, or ARS, at par value, at any time during a two-year sale period beginning June 30, 2010, or the Settlement Rights. As a result of the lack of either quoted market prices or other observable market data, we estimate the value of our ARS and Settlement Rights using discounted cash flow analyses using Level 3 inputs as defined by the accounting guidance related to fair value measurements. We elected the fair value option with respect to the Settlement Rights in accordance with current accounting guidance related to the fair value option for financial assets and financial liabilities. We have recorded an asset equal to our estimated fair value of the Settlement Rights of approximately $0.8 million in our condensed consolidated balance sheet as of both March 31, 2010 and December 31, 2009, representing no change to the estimated fair value of our Settlement Rights from the estimated fair value at December 31, 2009. In addition, with the opportunity provided by the Settlement Rights, we have designated the ARS subject to the Settlement Rights with a par value of $9.3 million and an estimated fair value of $8.5 million as of March 31, 2010 as trading securities. Accordingly, as of March 31, 2010, we have adjusted our estimated value of these trading securities by $4,000 from the estimated value at December 31, 2009, which we have recorded as a gain on investments in other income (expense) in our condensed consolidated statement of operations.

We expect interest and dividend income to increase for the remainder of 2010 as a result of the investment of excess cash balances, principally as the result of our January 2010 sale of 3.6 million shares of our common stock at a public offering price of $48.25 per share and which resulted in net proceeds to us of approximately $165.6 million.

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Income Tax Benefit

During the three months ended March 31, 2010 we recognized no tax expense or benefit due to our continued net operating loss position as compared to a $0.2 million tax benefit recognized during the three months ended March 31, 2009 associated with U.S. research and development tax credits against which we had previously provided a valuation allowance, but which became refundable as a result of legislation passed in February 2009.

Net Loss

For the reasons stated above, we incurred a net loss of $23.1 million, or $1.15 per basic and diluted share, for the three months ended March 31, 2010 as compared to a net loss of $26.4 million, or $1.55 per basic and diluted share, for the three months ended March 31, 2009.

Liquidity and Capital Resources

General

We finance our operations primarily from the sale of Feraheme , the sale of our common stock, cash generated from our investing activities, and payments from our strategic partners. Our long-term capital requirements will depend on many factors, including, but not limited to, the following:

· Our ability to successfully commercialize Feraheme in the U.S. as an IV iron replacement therapeutic agent;

· The magnitude of Feraheme sales and the timing of the receipt of cash from such sales;

· Our ability to achieve the various milestones and receive the associated payments under the Takeda Agreement;

· Costs associated with the U.S. commercialization of Feraheme , including costs associated with maintaining our commercial infrastructure, executing our promotional and marketing strategy for Feraheme and conducting post-marketing clinical studies;

· Costs associated with our development of additional indications for Feraheme in the U.S.;

· Costs associated with our pursuit of approval for Feraheme as an IV iron replacement therapeutic agent outside of the U.S.;

· Costs associated with commercial-scale manufacturing of Feraheme , including costs of raw materials and costs associated with maintaining commercial inventory and qualifying additional manufacturing capacities and second source suppliers;

· Costs associated with potential business development and in-licensing activities;

· Our ability to liquidate our investments in ARS, in a timely manner and without significant loss;

· The impact of the current state of the credit and capital markets upon the investments in our portfolio;

· Our ability to maintain successful collaborations with our partners and/or to enter into additional alternative strategic relationships, if necessary; and

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· Our ability to raise additional capital on terms and within a timeframe acceptable to us, if necessary.

As of March 31, 2010, our investments consisted of corporate debt securities, U.S. treasury and government agency securities, and ARS. We place our cash and investments in instruments that meet high credit quality standards, as specified in our investment policy. Our investment policy also limits the amount of our credit exposure to any one issue or issuer and seeks to manage these assets to achieve our goals of preserving principal, maintaining adequate liquidity at all times, and maximizing returns.

Cash and cash equivalents and investments at March 31, 2010 and December 31, 2009 consisted of the following (in thousands):

	March 31, 2010		December 31, 2009		$ Change			% Change
Cash and cash equivalents	$	212,747	$	50,126	$	162,621		>100	%
Short-term investments	21,044		29,578		(8,534		)	-29	%
Long-term investments	48,432		49,013		(581		)	-1	%
Total cash, cash equivalents and investments	$	282,223	$	128,717	$	153,506		119	%

The increase in cash and cash equivalents and investments as of March 31, 2010 as compared to December 31, 2009 is primarily the result of net proceeds of $165.6 million from our January 2010 public offering, cash received from Feraheme sales and interest income partially offset by cash used in operations.

As of March 31, 2010, we believe that our cash, cash equivalents, and short-term investments, combined with the $60 million we received in April 2010 as an upfront payment pursuant to the Takeda Agreement, and the cash we currently expect to receive from sales of Feraheme and earnings on our investments, will be sufficient to satisfy our future cash flow needs for at least the next twelve months, including projected operating expenses related to our ongoing development and commercialization programs for Feraheme .

The ongoing uncertainty in the global financial markets has had an adverse impact on financial market activities world-wide, resulting in, among other things, volatility in security prices, diminished liquidity and credit availability, ratings downgrades of certain investments and declining valuations of others. Although we invest our excess cash in investment grade securities, there can be no assurance that changing circumstances will not affect our future financial position, results of operations or liquidity.

Cash flows from operating activities

During the three months ended March 31, 2010, our use of $12.4 million of cash in operations was due principally to our net loss of approximately $23.1 million adjusted for the following:

· Approximately $10.0 million received in connection with sales deferred under our Launch Incentive Program;

· Additional costs of $2.5 million capitalized to inventory as of March 31, 2010;

· A decrease of $2.4 million in accounts receivable, excluding sales deferred under our Launch Incentive Program;

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· A decrease of $2.7 million in accounts payable and accrued expenses, including an increase of $0.7 million of reserves for commercial discounts and rebates;

· Non-cash operating items of $4.9 million including equity-based compensation expense, depreciation and amortization, income tax benefit, and other non-cash items; and

· Changes in other operating assets and liabilities of $1.4 million, which reflect timing differences between the receipt and payment of cash associated with certain transactions and when such transactions are recognized in our results of operations.

Our net loss for the three months ended March 31, 2010 was primarily the result of commercialization costs, including advertising and promotion costs, compensation and other expenses, research and development costs, including clinical trials, and general and administrative costs partially offset by net product revenues.

Cash flows from investing activities

Cash provided by investing activities was $8.7 million during the three months ended March 31, 2010 and was primarily attributable to net proceeds from the sales and maturities of our investments.

Cash flows from financing activities

Cash provided by financing activities was $166.3 million during the three months ended March 31, 2010. In January 2010, we sold 3.6 million shares of our common stock at a public offering price of $48.25 per share and which resulted in net proceeds to us of approximately $165.6 million.

Contractual Obligations

Our contractual obligations primarily consist of our obligations under non-cancellable operating leases and other purchase obligations as described in our Annual Report on Form 10-K for the year ended December 31, 2009. Other than as described below, there have been no significant changes in our contractual obligations since December 31, 2009.

Legal Proceedings

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Off-Balance Sheet Arrangements

As of March 31, 2010, we did not have any off-balance sheet arrangements as defined in Regulation S-K, Item 303(a)(4)(ii).

Critical Accounting Policies

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make certain estimates and assumptions that affect the reported amount of assets, liabilities, revenues and expenses, and the related disclosure of contingent assets and liabilities. The most significant estimates and assumptions are used in, but are not limited to, revenue recognition and related sales allowances, assessing investments for potential other-than-temporary impairment and determining values of investments, reserves for doubtful accounts, accrued expenses, income taxes and equity-based compensation expense. Actual results could differ materially from those estimates. In making these estimates and assumptions, management employs critical accounting policies. Our critical accounting policies and estimates are discussed in our Annual Report on Form 10-K for the year ended December 31, 2009. There have been no significant changes to these critical accounting policies and estimates since December 31, 2009.

Impact of Recently Issued and Proposed Accounting Pronouncements

In February 2010, the Financial Accounting Standards Board, or FASB, issued Accounting Standard Update, or ASU, No. 2010-09, Subsequent Events: Amendments to Certain Recognition and Disclosure Requirements, or ASU 2010-09, which amends Accounting Standards Codification, or ASC, 855 to address certain implementation issues related to an entity’s requirement to perform and disclose subsequent events procedures. The amendments in ASU 2010-09 remove the requirement for an SEC filer to disclose a date through which subsequent events have been evaluated in both issued and revised financial statements. We adopted this guidance as of its issuance date and because this guidance only amends required disclosures in our condensed consolidated financial statements, it did not have an effect upon our financial position or results of operations.

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and because this guidance only amends required disclosures in our condensed consolidated financial statements, it did not have an effect upon our financial position or results of operations. We do not expect the adoption of the remaining provisions of this amendment to have a significant impact on our consolidated financial statements.

In October 2009, the FASB issued ASU No. 2009-13, Multiple-Deliverable Revenue Arrangements, or ASU 2009-13. ASU 2009-13 amends existing revenue recognition accounting pronouncements that are currently within the scope of FASB ASC Subtopic 605-25 (previously included within Emerging Issues Task Force, or EITF, No. 00-21, Revenue Arrangements with Multiple Deliverables, or EITF 00-21). The consensus to EITF Issue No. 08-1, Revenue Arrangements with Multiple Deliverables, or EITF 08-1, provides accounting principles and application guidance on whether multiple deliverables exist, how the arrangement should be separated, and the consideration allocated. This guidance eliminates the requirement to establish the fair value of undelivered products and services and instead provides for separate revenue recognition based upon management’s estimate of the selling price for an undelivered item when there is no other means to determine the fair value of that undelivered item. EITF 00-21 previously required that the fair value of the undelivered item be the price of the item either sold in a separate transaction between unrelated third parties or the price charged for each item when the item is sold separately by the vendor. This was difficult to determine when the product was not individually sold because of its unique features. Under EITF 00-21, if the fair value of all of the elements in the arrangement was not determinable, then revenue was deferred until all of the items were delivered or fair value was determined. This new approach is effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. Early adoption is permitted; however, adoption of this guidance as of a date other than January 1, 2011 will require us to apply this guidance retrospectively to January 1, 2010 and will require disclosure of the effect of this guidance as applied to all previously reported interim periods in the fiscal year of adoption. We are currently evaluating the potential impact of this standard on our condensed consolidated financial statements, specifically with respect to our accounting and disclosures related to the Takeda collaboration.

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first quarter of 2010 which did not have a significant impact on our condensed consolidated financial statements.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

As of March 31, 2010, our short- and long-term investments totaled $69.5 million and were invested in corporate debt securities, U.S. treasury and government agency securities, and ARS. These investments are subject to interest rate risk and will fall in value if market interest rates increase. However, even if market interest rates for comparable investments were to increase immediately and uniformly by 50 basis points, or one-half of a percentage point, from levels at March 31, 2010, this would have resulted in a hypothetical decline in fair value of our investments, excluding ARS, which are described below, of less than $0.1 million.

At March 31, 2010, we held a total of $56.9 million in fair market value of ARS, reflecting a decline in value of approximately $8.0 million compared to the par value of these securities of $64.9 million. In February 2008, our ARS began to experience failed auctions and have continued to experience failed auctions. As a result of the lack of observable ARS market activity since that time, we use a discounted cash flow analysis to value these securities as opposed to valuing them at par value. Our valuation analysis considers, among other items, assumptions that market participants would use in their estimates of fair value, such as the collateral underlying the security, the creditworthiness of the issuer and any associated guarantees, credit ratings of the security by the major securities rating agencies, the ability or inability to sell the investment in an active market, the timing of expected future cash flows, and the expectation of the next time the security will have a successful auction or when call features may be exercised by the issuer. Based upon this methodology, we have recorded a $7.2 million unrealized loss related to our ARS, other than those subject to Settlement Rights, to accumulated other comprehensive loss as of March 31, 2010. In November 2008, we elected to participate in a rights offering by UBS which provides us with rights to sell to UBS $9.3 million in par value of our ARS portfolio, at par value, at any time during a two-year sale period beginning June 30, 2010. In accordance with current accounting guidance related to the fair value option for financial assets and financial liabilities, we have recorded an asset equal to the estimated fair value of the Settlement Rights of approximately $0.8 million in our condensed consolidated balance sheet at March 31, 2010.

We believe there are several significant assumptions that are utilized in our valuation analysis, the two most critical of which are the discount rate and the average expected term. Holding all other factors constant, if we were to increase the discount rate utilized in our valuation analysis by 50 basis points, or one-half of a percentage point, this change would have the effect of reducing the fair value of our ARS by approximately $1.2 million as of March 31, 2010. Similarly, holding all other factors constant, if we were to increase the average expected term utilized in our fair value calculation by one year, this change would have the effect of reducing the fair value of our ARS by approximately $1.5 million as of March 31, 2010.

Item 4. Controls and Procedures.

Managements’ Evaluation of our Disclosure Controls and Procedures

Our principal executive officer and principal financial officer, after evaluating the effectiveness of our “disclosure controls and procedures” (as defined in the Exchange Act Rule 13a-15(e), or Rule 15d-15(e)), with the participation of our management, have each concluded that, as of the end of the period covered by this Quarterly Report on Form 10-Q, our disclosure controls and procedures were effective and were designed to ensure that information we are required to disclose in the reports that we file or submit under the Securities Exchange Act of 1934, as amended, is accumulated and communicated to management, including our principal executive officer and principal financial officer, as appropriate, to allow timely

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decisions regarding required disclosure, and is recorded, processed, summarized and reported within the time periods specified in the U.S. Securities and Exchange Commission’s rules and forms. It should be noted that any system of controls is designed to provide reasonable, but not absolute, assurances that the system will achieve its stated goals under all reasonably foreseeable circumstances. Our principal executive officer and principal financial officer have each concluded that our disclosure controls and procedures as of the end of the period covered by this report are effective at a level that provides such reasonable assurances.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting that occurred during the three months ended March 31, 2010 that materially affected, or that are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

Item 1. Legal Proceedings

Item 1A. Risk Factors

The following is a summary description of some of the material risks and uncertainties that may affect our business, including our future financial and operational results. In addition to the other information in this Quarterly Report on Form 10-Q, the following statements should be carefully considered in evaluating us.

We are solely dependent on the success of Feraheme.

Our ability to generate future revenues is solely dependent on our successful commercialization and development of Feraheme. We currently sell only one other product, GastroMARK , in the U.S. and in certain foreign jurisdictions through our marketing partners. However, sales of GastroMARK have been at their current levels for the last several years, and we do not expect sales of GastroMARK to materially increase. Accordingly, if we are unable to generate sufficient revenues from sales of Feraheme , we may never be profitable, our financial condition will be materially adversely affected, and our business prospects will be limited.

We intend to dedicate significant resources to our Feraheme development efforts; however, we may not be successful in expanding the potential indications or developing new applications for Feraheme . Although we are pursuing or have commenced additional clinical trials for Feraheme in indications other than chronic kidney disease, or CKD, and as an imaging agent, we are not currently conducting or sponsoring research to

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expand our product development pipeline beyond Feraheme and therefore our revenues and operations will not be as diversified as some of our competitors which have multiple products or product candidates. Any failure by us to acquire, develop and commercialize additional products and product candidates or gain approval for additional indications or uses for Feraheme could limit long-term shareholder value and would adversely affect the future prospects of our business.

Competition in the pharmaceutical and biopharmaceutical industries is intense. If our competitors are able to develop and market products that are or are perceived to be more effective, safer, more convenient or have more favorable pricing, insurance coverage, coding and reimbursement than Feraheme, the commercial opportunity for Feraheme will be adversely impacted.

The pharmaceutical and biopharmaceutical industries are subject to intense competition and rapid technological change. We have competitors both in the U.S. and internationally, and many have greater financial and other resources, and more experienced trade, sales, and manufacturing organizations, than we do. In addition, many of our competitors have name recognition, established positions in the market and long-standing relationships with customers and distributors. Our Feraheme commercial opportunity will be reduced or eliminated if our competitors develop, commercialize or acquire or license technologies and drug products that are or are perceived to be safer, more effective, and/or easier to administer, or have more favorable pricing, insurance coverage, coding and reimbursement than Feraheme .

There are currently two options for treating iron deficiency anemia, or IDA, in CKD patients: oral iron supplements and intravenous, or IV, iron. Feraheme primarily competes with two other IV iron replacement therapies, including Venofer ® , which is marketed in the U.S. by Fresenius Medical Care North America, or Fresenius, and American Regent Laboratories, Inc., a subsidiary of Luitpold Pharmaceuticals, Inc., or Luitpold, and Ferrlecit ® , which is marketed by Sanofi-Aventis U.S. LLC. Feraheme may not receive the same level of market acceptance as these competing iron replacement therapy products, especially since these products have been on the market longer and are currently widely used by physicians. We may not be able to convince physicians and other healthcare providers or payors to switch from using the other marketed IV iron therapeutic products to Feraheme . The iron replacement therapy market is highly sensitive to several factors including, but not limited to, the actual and perceived safety profile of the available products, the ability to obtain appropriate insurance coverage, coding and reimbursement, price competitiveness, and product characteristics such as convenience of administration and dosing regimens. To date, we have not completed any head-to-head clinical studies comparing Feraheme to other IV iron replacement products.

In addition to the foregoing currently marketed products, there are several iron replacement therapy products in various stages of clinical and commercial development in the U.S. and abroad, including Monofer ® (iron isomaltoside 1000), an injectable iron preparation which in December 2009 received a positive recommendation in 22 European countries and a final marketing authorization in Denmark, Iceland and the Netherlands for the treatment of IDA, Injectafer ® , which is known as Ferinject ® in Europe and is approved for marketing in 19 European Union countries, and soluble ferric pyrophosphate, a form of iron given as part of the hemodialysis procedure.

In addition to competition from other marketed products and products known by us to be currently under development, the market opportunity for Feraheme could be negatively affected if generic IV iron replacement therapy products were to be approved and achieve commercial success. For example, in July 2009, Watson Pharmaceuticals, Inc. announced that it entered into a license agreement with GeneraMedix, Inc. for the exclusive U.S. marketing rights to a generic version of Ferrlecit ® , which is indicated for the treatment of IDA in hemodialysis patients receiving supplemental erythropoiesis stimulating agent therapy. GeneraMedix, Inc. has filed an Abbreviated New Drug Application, or NDA,

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with the U.S. Food and Drug Administration, or FDA, which is under expedited review. Companies that manufacture generic products typically invest far less resources in research and development than the manufacturer of a branded product and can therefore price their products significantly lower than those already on the market. It remains unclear if and when a generic product will enter this market.

If any of these product candidates are approved for marketing and sale by the FDA, our efforts to market and sell Feraheme and our ability to generate additional revenues and achieve profitability could be adversely affected.

Feraheme may not be widely adopted by physicians, patients, healthcare payors, and the major operators of dialysis clinics in the U.S.

The commercial success of Feraheme depends upon its level of market adoption by physicians, patients, and healthcare payors or providers, including dialysis clinics. If Feraheme does not achieve an adequate level of market adoption for any reason, our potential profitability and our future business prospects would be severely adversely impacted. Feraheme represents an alternative to other products and might not be adopted by the medical community if perceived to be no safer, no more effective, or no more convenient than currently available products. The degree of market acceptance of Feraheme depends on a number of factors, including but not limited to:

· Our ability to demonstrate to the medical community, particularly nephrologists, hematologists, dialysis clinics, hospitals and others who may purchase or prescribe Feraheme , the clinical efficacy and safety of Feraheme as an alternative to current treatments for IDA in both dialysis and non-dialysis CKD patients;

· The ability of physicians and other providers to be adequately reimbursed for Feraheme in a timely manner from payors, including government payors, such as Medicare and Medicaid, and private payors, particularly in light of the expected “bundling” of costs of providing care to dialysis patients;

· The relative price of Feraheme as compared to alternative iron replacement therapeutic agents;

· The actual or perceived convenience and ease of administration of Feraheme as compared to alternative iron replacement therapeutic agents;

· The effectiveness of our sales and marketing organizations and our distribution network; and

· The development of unanticipated adverse reactions to Feraheme resulting in safety concerns among prescribers.

We market and sell Feraheme for use by both dialysis and non-dialysis CKD patients. The dialysis market is the largest and most established market for IV iron replacement therapies, with two companies serving a significant majority of all dialysis patients in the U.S. Fresenius and DaVita, Inc., or DaVita, together treat approximately two-thirds of the U.S. dialysis population. If we are unable to successfully market and sell Feraheme to physicians who treat dialysis dependent CKD patients in clinics controlled by either or both of Fresenius and DaVita, our ability to realize and grow revenues from sales of Feraheme could be limited. In addition, if we are unable to successfully market and sell Feraheme to a significant number of the dialysis clinics that treat the remaining one-third of the U.S. dialysis population, our potential profitability and our future business prospects could be materially adversely impacted.

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In September 2008, Fresenius finalized an exclusive sublicense agreement with Luitpold, the U.S. licensing partner of Vifor Pharma, a subsidiary of Galenica Ltd., to manufacture, sell and distribute Venofer ® to independent outpatient dialysis clinics in the U.S. Luitpold retains the right to sell Venofer ® in the U.S. to any other customer. In addition, Galenica Ltd., Vifor Pharma and Fresenius entered into a strategic joint-venture, which became effective on January 1, 2009, to market and distribute the IV iron products Venofer ® and Ferinject ® in the dialysis market in Europe, the Middle East, Africa and Latin America. Fresenius has significant experience selling and distributing dialysis equipment and supplies to outpatient dialysis clinics which, together with these agreements, make it difficult for us to penetrate the dialysis market, particularly at its clinics.

Another key component of our commercialization strategy is to market and sell Feraheme for use by non-dialysis CKD patients. The current non-dialysis market is comprised primarily of three segments: hospitals, hematology clinics and nephrology clinics. Our ability to effectively market and sell Feraheme in the hospital market depends in part upon our ability to achieve acceptance of Feraheme onto hospital formularies. In addition, since many hospitals are members of group purchasing organizations, which leverage the purchasing power of a group of entities to obtain discounts based on the collective bargaining power of the group, our ability to attract customers in the hospital market also depends in part on our ability to effectively promote Feraheme within group purchasing organizations. In addition, IV iron therapeutic products are not currently widely used by certain physicians who treat non-dialysis CKD patients due to safety concerns and the inconvenience and often impracticability of administering IV iron therapeutic products. It is often difficult to change physicians’ existing treatment paradigms even when supportive clinical data is available. If we are not successful in securing and maintaining formulary coverage for Feraheme or are significantly delayed in doing so or if we are not successful in effectively promoting Feraheme to physicians who treat non-dialysis CKD patients, we will have difficulty achieving market acceptance of Feraheme in the non-dialysis market and our ability to generate revenues and achieve and maintain profitability, and our long-term business prospects, could be adversely affected.

Our ability to generate future revenues from Feraheme depends heavily on the ability of end-users to receive adequate reimbursement for the use of Feraheme in a timely manner.

The commercial success of Feraheme substantially depends on the availability and extent of reimbursement for Feraheme from third-party payors, including governmental payors, such as Medicare and Medicaid, and private payors. Feraheme is purchased by hospitals, clinics, dialysis centers, physicians and other users, each of which generally relies on third-party payors to reimburse them or their patients for pharmaceutical products administered in the hospital, clinic, dialysis center and physician-office settings. Public and private insurance coverage and reimbursement plans are therefore central to new product acceptance, with customers unlikely to use Feraheme if they do not receive adequate reimbursement in a timely manner. If Feraheme is not reimbursed at an adequate level, our ability to generate revenues from sales of Feraheme , our potential profitability and our future business prospects would be adversely affected .

In the U.S. there have been, and we expect there will continue to be, a number of federal and state proposals to reform the healthcare system in ways that could adversely impact the available reimbursement for, and therefore our ability to sell Feraheme profitably.

In the U.S., both federal and state agencies continue to promote efforts to reduce healthcare costs. For example, among other things, the recently enacted federal healthcare legislation requires pharmaceutical manufacturers to be responsible for higher minimum Medicaid rebates owed to state Medicaid agencies, extends the rebate provisions to Medicaid managed care organizations, and expands the 340(b) Public Health Services drug pricing program. As a result of these and other reimbursement and legislative proposals, and the trend toward managed health care in the U.S., third-party payors, including government

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and private payors, are also increasingly attempting to contain health care costs by limiting the coverage and the level of reimbursement of new drugs. These cost-containment methods may include, but are not limited to, using formularies, which are lists of approved or preferred drugs, requiring prior authorization or step therapy, which is a program to encourage using lower cost alternative treatments, basing payment amounts on the least costly alternative treatment, or refusing to provide coverage of approved products for medical indications other than those for which the FDA has granted marketing approval. Cost control initiatives could adversely affect the commercial opportunity or decrease the price of Feraheme and may impede the ability of potential Feraheme users to obtain reimbursement, any of which could have a material adverse effect on our profitability and future business prospects.

Medicare currently reimburses for physician-administered drugs in the hospital outpatient, dialysis center and physician clinic settings at a rate of 106% of the drug’s average selling price, or ASP. If the Centers for Medicare & Medicaid Services, or CMS, or one of its local contractors, believe that Feraheme ’s ASP is too high, it may attempt to initiate one or more of the cost-containment methods discussed above at either the national or local level. In addition, in July 2008, Congress enacted the Medicare Improvements for Patients and Providers Act of 2008, or MIPPA, which created a Medicare-expanded bundled payment system for the treatment of end stage renal disease, or ESRD, to be implemented by January 1, 2011. MIPPA requires CMS to move from a system in which it pays separately for physician-administered drugs for dialysis patients to a system in which all costs of providing care to dialysis patients are bundled together into a single capitated payment. The ESRD expanded bundle is to be phased in beginning on January 1, 2011, and the phase-in must be completed by January 1, 2014. In September 2009, in compliance with the statutory requirements of MIPPA, CMS proposed a new prospective payment system for dialysis services provided to Medicare beneficiaries who have ESRD. CMS has stated that it intends to issue a final rule on the prospective payment system later in 2010 in order to meet the legislative requirements of implementation by January 1, 2011. This bundled approach to reimbursement may lower utilization of physician-administered drugs in the ESRD market. In addition, the bundled approach to reimbursement in the dialysis setting may lower the amount of reimbursement available for Feraheme and consequently put downward pressure on the price we can charge for Feraheme . Therefore, we may be limited in our ability to successfully market and sell Feraheme in the dialysis setting. While the MIPPA ESRD provisions apply only to Medicare, Medicare payment policy can also influence pricing and reimbursement in the non-Medicare markets, as private third-party payors and state Medicaid plans frequently adopt Medicare principles in setting reimbursement methodologies, particularly in the ESRD setting. Any change in the Medicare reimbursement rate would, therefore, likely result in changes to payment rates from non-Medicare payors as well, further limiting our ability to successfully market and sell Feraheme .

To the extent we sell our products internationally, market acceptance may also depend, in part, upon the availability of reimbursement within existing healthcare payment systems. Generally, in Europe and other countries outside of the U.S., the government sponsored healthcare system is the primary payor of healthcare costs of patients and therefore enjoys significant market power. Some foreign countries also set prices for pharmaceutical products as part of the regulatory process, and we cannot guarantee that the prices set by such governments will be sufficient to generate substantial revenues in those countries.

Significant safety or drug interaction problems could arise with respect to Feraheme, resulting in recalls, restrictions in Feraheme’s label, withdrawal of Feraheme from the market, or cause us to alter or terminate future Feraheme clinical development programs.

Discovery of previously unknown problems with an approved product may result in recalls, restrictions on the product’s permissible uses, or withdrawal of the product from the market. The data submitted to the FDA as part of our NDA was obtained in controlled clinical trials of limited duration. New safety or drug interaction issues may arise as Feraheme is used over longer periods of time by a wider group of patients

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taking numerous other medicines and with additional underlying health problems. In addition, as we conduct additional clinical trials for Feraheme , new safety problems may be identified which could negatively impact both our ability to successfully complete these studies and the use and/or regulatory status of Feraheme for the treatment of IDA in patients with CKD. These new safety or drug interaction issues may require us to provide additional warnings on the Feraheme label, directly alert healthcare providers of new safety information, narrow our approved indications, or alter or terminate future trials planned for additional uses of Feraheme , any of which could reduce the market acceptance of Feraheme . In addition, if significant safety or drug interaction issues arise, FDA approval for Feraheme could be withdrawn, and the FDA could require the recall of all existing Feraheme in the marketplace. The FDA also has the authority to require the recall of our products if there is contamination or other problems with manufacturing, transport or storage of the product. A government-mandated recall or a voluntary recall could divert managerial and financial resources, could be difficult and costly to correct, could result in the suspension of sales of Feraheme , and could have a severe adverse impact on our potential profitability and the future prospects of our business.

We may also be required to conduct certain post-approval clinical studies to assess known or suspected significant risks associated with Feraheme . The Food and Drug Administration Amendments Act of 2007 expanded the FDA’s authority. Under the Food and Drug Administration Amendments Act of 2007, the FDA may: (i) require manufacturers to conduct post-approval clinical studies to assess known risks or signals of serious risks, or to identify unexpected serious risks; (ii) mandate labeling changes to a product based on new safety information; or (iii) require sponsors to implement a Risk Evaluation Management Strategy, or REMS, where necessary to assure safe use of the drug. If we are required to conduct post-approval clinical studies or implement a REMS, or if the FDA changes the label for Feraheme to include additional discussion of potential safety issues, such requirements or restrictions could have a material adverse impact on our ability to generate revenues from sales of Feraheme , or require us to expend significant additional funds on clinical studies.

We have limited experience independently commercializing a pharmaceutical product, and any failure on our part to effectively execute our Feraheme commercial plans would have a severe adverse impact on our business.

Prior to our commercialization of Feraheme , we have never independently marketed or sold a drug product as we had relied on our corporate partners to market and sell our previously approved products. We have established an internal sales and marketing infrastructure to market and sell Feraheme , and if we are unsuccessful in maintaining an effective sales and marketing function or experience a high level of turnover, then the commercialization of Feraheme could be severely impaired. Any failure by us to successfully execute our commercialization plans for Feraheme could have a material adverse impact on our ability to generate revenues, our ability to achieve profitability, and the future prospects for our business.

We have limited experience independently distributing a pharmaceutical product, and our Feraheme commercialization plans could suffer if we fail to effectively manage and maintain our supply chain and distribution network.

We do not have significant experience in managing and maintaining a supply chain and distribution network, and we are placing substantial reliance on third-parties to perform product supply chain services for us. Such services include packaging, warehousing, inventory management, storage and distribution of Feraheme . We have contracted with Integrated Commercialization Services, Inc., or ICS, to be our exclusive third party logistics provider to perform a variety of functions related to the sale and distribution of Feraheme , including services related to warehousing and inventory management, distribution, chargeback processing, accounts receivable management and customer service call center management. As

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a result, most of our inventory is stored at a single warehouse maintained by ICS. In addition, we have contracted with Catalent Pharma Solutions, LLC, or Catalent, to provide certain labeling and packaging services for final Feraheme drug product. If ICS or Catalent are unable to provide uninterrupted supply chain services or labeling and packaging services, respectively, we may incur substantial losses of sales to wholesalers or other purchasers of Feraheme .

In addition, the packaging, storage and distribution of Feraheme requires significant coordination among our manufacturing, sales, marketing and finance organizations and multiple third parties including our third party logistics provider, packaging and labeling provider, distributors, and wholesalers. In most cases, we do not currently have back-up suppliers or service providers to perform these tasks. If any of these third-parties experience significant difficulties in their respective processes, fail to maintain compliance with applicable legal or regulatory requirements, fail to meet expected deadlines or otherwise do not carry out their contractual duties to us, or encounter physical or natural damages at their facilities, our ability to deliver Feraheme to meet commercial demand would be significantly impaired. The loss of any of our third party providers, together with a delay or inability to secure an alternate distribution source for end users, could cause the distribution of Feraheme to be delayed or interrupted, which would have an adverse effect on our business, financial condition and results of operation.

We may not be able to operate our manufacturing facility in compliance with current good manufacturing practices and other FDA regulations, which could result in a suspension of our ability to manufacture Feraheme, the loss of our Feraheme inventory, our inability to manufacture sufficient quantities of Feraheme to meet demand, or other unanticipated compliance costs.

Our Cambridge, Massachusetts manufacturing facility is subject to current good manufacturing practices, or cGMP, regulations enforced by the FDA through periodic inspections to confirm such compliance. We must continually expend time, money and effort in production, record-keeping and quality assurance and control to ensure that our manufacturing facility meets the FDA’s regulatory requirements. Failure to maintain ongoing compliance with cGMP regulations and other applicable manufacturing requirements of various regulatory agencies could result in the FDA’s issuance of Warning Letters, fines, the withdrawal or recall of Feraheme from the marketplace, total or partial suspension of Feraheme production, the loss of our Feraheme inventory, suspension of the FDA’s review of any future supplemental NDAs, enforcement actions, injunctions or criminal prosecution. If the FDA inspects our manufacturing facility and determines that we are not in compliance with cGMP regulations or we otherwise determine that we are not in compliance with these regulations, we could experience an inability to manufacture sufficient quantities of Feraheme to meet demand or incur unanticipated compliance expenditures, either of which could have an adverse impact on Feraheme sales, our potential profitability and the future prospects of our business.

We currently manufacture Feraheme at one manufacturing facility without a qualified second source manufacturer, and if we experience any difficulties, disruptions or delays in the manufacturing process, we may not be able to produce sufficient quantities of Feraheme to meet commercial demand or continue our Feraheme development efforts.

We currently manufacture Feraheme for commercial use and for use in human clinical trials in our Cambridge, Massachusetts manufacturing facility. Although we are working to establish and qualify second source manufacturing facilities, we currently have only one facility at which we produce Feraheme . Our ability to manufacture Feraheme in sufficient quantities to meet commercial demand and our clinical development needs at acceptable costs is dependent on the uninterrupted and efficient operation of our manufacturing facility. If there are any difficulties, disruptions or delays in the Feraheme manufacturing process, including quality control problems, we may experience manufacturing failures which could result

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in product defects or shipment delays, recall or withdrawal of products previously shipped for commercial or clinical purposes, inventory write-offs or the inability to meet commercial demand for Feraheme in a timely and cost-effective manner. Furthermore, if we fail to continue to attract and retain key members of our manufacturing or quality departments, we may be unable to manufacture sufficient quantities of Feraheme in a timely manner, which could delay or impair our product sales and development efforts.

If we cannot produce sufficient quantities of Feraheme at our manufacturing facility, we will need to rely on third party manufacturers, which may expose us to a number of risks.

If we are unable to produce sufficient quantities of Feraheme to meet demand or we experience any manufacturing difficulties at our Cambridge, Massachusetts manufacturing facility, we will be required to enter into arrangements with third-party manufacturers. We are currently working to establish and qualify second source manufacturing facilities for Feraheme , however we may not be able to enter into agreements with manufacturers whose facilities and procedures comply with cGMP, regulations and other regulatory requirements on terms that are favorable to us, if at all. Even if we were to reach agreement, the transition of the manufacturing process to a third party could take a significant amount of time. Any prolonged interruption in our manufacturing operations could result in cancellations of orders or loss of product in the manufacturing process. Furthermore, use of second-source manufacturing facilities may increase the risk of certain problems, including cost overruns, process reproducibility, stability issues, the inability to deliver required quantities of product that conform to specifications in a timely manner, or the inability to manufacture Feraheme in accordance with cGMP. If we are unable to consistently manufacture our products on a timely basis because of these or other factors, we may not be able to meet commercial demand or our clinical development needs for Feraheme . As a result, we may lose sales and fail to generate increased revenues and our clinical development programs may be delayed, which could have an adverse impact on our potential profitability and future business prospects.

Our inability to obtain raw materials and our reliance on sole source suppliers could adversely impact our ability to manufacture sufficient quantities of Feraheme, which would have a severe adverse impact on our business.

We currently purchase certain raw materials used to manufacture Feraheme from third-party suppliers. We do not have any long-term supply contracts with these third parties. Some of these raw materials are procured from a single source with no qualified alternative supplier. We are in the process of identifying and qualifying additional third-party suppliers for these raw materials used to manufacture Feraheme . Third-party suppliers may cease to produce the raw materials used in Feraheme or otherwise fail to supply these raw materials to us or fail to supply these raw materials to us in sufficient quantities for a number of reasons, including but not limited to the following:

· Unexpected demand for or shortage of raw materials;

· Labor disputes or shortages;

· Manufacturing difficulties;

· Regulatory requirements or action;

· Adverse financial developments at or affecting the supplier; or

· Import or export problems.

If any of our third-party suppliers cease to supply our raw materials for any reason, we will be unable to manufacture Feraheme or unable to manufacture Feraheme in sufficient quantities until we are able to

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qualify an alternative source, which would adversely affect our ability to satisfy commercial demand and our clinical development needs for Feraheme .

The qualification of an alternative source may require repeated testing of the new materials and generate greater expenses to us if materials that we test do not perform in an acceptable manner. In addition, we sometimes obtain raw materials from one vendor only, even where multiple sources are available, to maintain quality control and enhance working relationships with suppliers, which could make us susceptible to price inflation by the sole supplier, thereby increasing our production costs. As a result of the high quality standards imposed on our raw materials, we may not be able to obtain raw materials of the quality required to manufacture Feraheme from an alternative source on commercially reasonable terms, or in a timely manner, if at all.

Even if we are able to obtain raw materials from an alternative source, if these raw materials are not available in a timely manner or on commercially reasonable terms, we would be unable to manufacture Feraheme , both for commercial sale and for use in our clinical trials, on a timely and cost-effective basis. Any such difficulty in obtaining raw materials would severely hinder our ability to manufacture Feraheme and would have a material adverse impact on our ability to generate additional revenues and to achieve profitability.

Our ability to grow revenues from sales of Feraheme will be limited if we do not obtain approval, or if we experience significant delays in our efforts to obtain approval, to market Feraheme for additional indications in the U.S.

We have commenced or are pursuing additional clinical trials and plan to seek regulatory approval to market Feraheme in indications other than CKD in the U.S. There is no guarantee that we will be successful in completing any clinical trials for additional indications in a timely manner or that, if completed, the results of such clinical trials will demonstrate Feraheme to be safe and effective in such uses and/or patient populations.

The FDA imposes substantial requirements on the development and production of all drug products. Before obtaining regulatory approval for the commercial marketing and sale of Feraheme for additional indications, we must demonstrate through extensive human clinical trials that Feraheme is safe and efficacious for these new uses and in these new patient populations. Conducting clinical trials is a complex, time-consuming and expensive process that requires adherence to a wide range of regulatory requirements. The FDA has substantial discretion in the approval process and may decide that the results of our clinical trials are insufficient for approval or that Feraheme is not effective or safe in indications other than CKD. Clinical and other data is often susceptible to varying interpretations, and many companies that have believed their product candidates performed satisfactorily in clinical trials have nonetheless failed to obtain FDA approval for their products.

The FDA could also determine that our clinical trials and/or our manufacturing processes were not properly designed, were not conducted in accordance with federal laws and regulations, or were otherwise not properly managed. In addition, under the FDA’s current good clinical practices regulations, or cGCP, we are responsible for conducting, recording and reporting the results of clinical trials to ensure that the data and results are credible and accurate and that the trial participants are adequately protected. The FDA may conduct inspections of clinical investigator sites which are involved in our clinical development programs to ensure their compliance with cGCP regulations. If the FDA determines that we, our contract research organizations or our study sites fail to comply with applicable cGCP regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA may disqualify certain data generated from those sites or require us to perform additional clinical trials before approving our marketing applications,

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which could adversely impact our ability to obtain approval for Feraheme in indications other than CKD . Any such deficiency in the design, implementation or oversight of our clinical development programs could cause us to incur significant additional costs, experience significant delays in our efforts to obtain regulatory approval for Feraheme in indications other than CKD, or even prevent us from obtaining regulatory approval for Feraheme for additional indications. This would, in turn, materially adversely impact our cash position, our ability to increase revenues, our ability to achieve profitability, and the future prospects of our business.

In addition, our ability to complete our planned clinical trials in a timely manner depends on a number of factors, including:

· Our ability to identify and enter into contracts with prospective clinical sites in a timely manner;

· The rate of patient enrollment; and

· The ability of our contract research organizations to perform their oversight responsibilities and meet expected deadlines.

Any failure by us to obtain approval for additional Feraheme indications in the U.S. in a timely manner may limit the commercial success of Feraheme and our ability to grow our revenues.

We are substantially dependent upon our collaboration with Takeda Pharmaceutical Company Limited, or Takeda, to commercialize Feraheme in certain regions outside of the U.S., and if Takeda fails to fulfill its obligations or our collaboration is terminated, our plans to commercialize Feraheme outside of the U.S. may be adversely affected.

On March 31, 2010, we entered into a License, Development and Commercialization Agreement, or the Takeda Agreement, with Takeda. Under the Takeda Agreement, we granted exclusive rights to Takeda to develop and commercialize Feraheme as a therapeutic agent in Europe, Asia-Pacific countries (excluding Japan, China and Taiwan), the Commonwealth of Independent States, Canada, India and Turkey, or collectively, the Licensed Territory. We are highly dependent on Takeda for the commercialization and certain regulatory filings outside of the U.S. for Feraheme . If Takeda fails to perform its obligations under the Takeda Agreement or is ineffective in its commercialization of Ferahame in the Licensed Territory or if we fail to effectively manage our relationship with Takeda, our ability to and the extent to which we commercialize and obtain certain regulatory approvals of Feraheme outside of the U.S. would be significantly harmed. Further, if we fail to fulfill certain of our obligations under the Takeda Agreement, Takeda has the right to assume the responsibility of clinical development of Feraheme in the Licensed Territory, which would increase the cost of and delay the Feraheme development program outside of the U.S.

In addition, Takeda has the right to terminate the agreement under certain conditions. If Takeda terminates the Takeda Agreement, we would be required to either enter into alternative arrangements with third parties to develop and commercialize Feraheme in the Licensed Territories, which we may be unable to do, or to increase our internal sales and marketing infrastructure, both of which would likely result in significant additional expense and delay or termination of our Feraheme clinical development programs outside of the U.S.

Our ability to grow revenues from sales of Feraheme will be limited if we do not obtain approval, or if we experience significant delays in our efforts to obtain approval to market Feraheme in countries outside of the U.S.

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In order for Takeda, 3SBio Inc., or us to market and sell Feraheme in any country outside of the U.S, it will be necessary to obtain regulatory approval from the appropriate regulatory authorities. The requirements for regulatory approval vary widely from country to country and may in some cases be more rigorous than requirements in the U.S. Certain foreign regulatory authorities may require additional studies or studies designed with different clinical endpoints and/or comparators than those which we have already completed. The time required for approval may also be longer or shorter than in the U.S. In addition, in order to increase the number of patients available for enrollment in our clinical trials, we will conduct trials in geographies outside the U.S. We have no experience conducting clinical trials outside the U.S., and, therefore, we will need to expend substantial time and resources to identify and familiarize ourselves with the regulatory requirements of such foreign countries.

Any failure by us, Takeda or 3SBio Inc. to obtain approval for Feraheme in any countries outside of the U.S. in a timely manner may limit the commercial success of Feraheme and our ability to grow our revenues.

We rely on third parties in the conduct of our clinical trials, and if they fail to fulfill their obligations, our development plans may be adversely affected.

We rely on independent clinical investigators, contract research organizations and other third-party service providers to assist us in managing, monitoring and otherwise carrying out our clinical trials. We have and we plan to continue to contract with certain third-parties to provide certain services, including site selection, enrollment, monitoring and data management services. Although we depend heavily on these parties, we do not control them and, therefore, we cannot be assured that these third-parties will adequately perform all of their contractual obligations to us. If our third-party service providers cannot adequately fulfill their obligations to us in a timely manner and on a satisfactory basis or if the quality and accuracy of our clinical trial data is compromised due to failure to adhere to our protocols or regulatory requirements or if such third-parties otherwise fail to adequately discharge their responsibilities or meet deadlines, our development plans both in the U.S. and outside of the U.S. may be delayed or terminated, which would adversely impact our ability to generate revenues from Feraheme sales in additional indications and/or outside of the U.S.

Our operating results will likely fluctuate so you should not rely on the results of any single quarter to predict how we will perform over time.

Our future operating results will likely vary from quarter to quarter depending on a number of factors, some of which we cannot control, including but not limited to:

· The timing and magnitude of our recognition of revenues from sales of Feraheme;

· The timing and magnitude of our recognition of revenues from sales of Feraheme associated with purchases made under our Launch Incentive Program, and the possibility that such purchases will be returned and never recognized as revenue by us;

· The timing and magnitude of costs associated with the commercializati on of Feraheme in the U.S., including costs associated with maintaining our commercial infrastructure and executing our promotional and marketing strategy;

· Changes in buying patterns and inventory levels of our wholesalers or distributors;

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· The timing and magnitude of costs associated with our ongoing and planned clinical studies of Feraheme in connection with our pursuit of additional indications and our development of Feraheme in countries outside of the U.S;

· The timing and magnitude of milestone payments received under the Takeda Agreement;

· The timing and magnitude of costs associated with commercial-scale manufacturing of Feraheme , including costs of raw materials and costs associated with maintaining commercial inventory and qualifying additional manufacturing capacities and second source suppliers;

· Actual or anticipated difficulties, disruptions or delays associated with our manufacturing facility, packager, or supply chain and distribution network;

· Changes in laws and regulations concerning reimbursement for Feraheme , from government health administration authorities, private health insurers and other third-party payors;

· The outcome of any material litigation to which we are a party; and

· Implementation of new or revised accounting or tax rules or policies.

As a result of these and other factors, our quarterly operating results could fluctuate, and this fluctuation could cause the market price of our common stock to decline. Results from one quarter should not be used as an indication of future performance.

Wholesaler and distributor buying patterns and other factors may cause our quarterly results to fluctuate, and these fluctuations may adversely affect our short-term results.

Our results of operations, including, in particular, product sales revenues, may vary from period to period due to a variety of factors, including the buying patterns of our wholesalers and distributors, which vary from quarter to quarter. In the event wholesalers and distributors with whom we do business determine to limit their purchases of our products, sales of our products could be adversely affected. For example, in advance of an anticipated price increase, customers may order Feraheme in larger than normal quantities which could cause sales of Feraheme to be lower in subsequent quarters than they would have been otherwise. Further, any changes in purchasing patterns, inventory levels, increases in returns of Feraheme, delays in purchasing products or delays in payment for products by one of our distributors could also have a negative impact on our revenue and results of operations.

If the estimates we make, or the assumptions on which we rely, in preparing our condensed consolidated financial statements prove inaccurate, our actual results may vary from those reflected in our projections and accruals .

Our condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of our assets, liabilities, revenues and expenses, the amounts of charges accrued by us, and the related disclosure of contingent assets and liabilities. On an ongoing basis, our management evaluates our critical and other significant estimates and judgments, including among others, those related to revenue recognition and related sales allowances, investments, reserves for doubtful accounts, equity-based compensation, accrued expenses and income taxes. We base our estimates on market data, our observance of trends in our industry, and on various other assumptions that we believe to be reasonable under the circumstances. If

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actual results differ from these estimates, there could be a material adverse effect on our financial results and the performance of our stock. For instance, the recently enacted federal healthcare legislation requires pharmaceutical manufacturers to be responsible for higher minimum Medicaid rebates owed to state Medicaid agencies, extends the rebate provisions to Medicaid managed care organizations, and expands the 340(b) Public Health Services drug pricing program. We are still assessing the full extent of this legislation’s future impact on our business.

As part of our revenue recognition policy, our estimates of product returns, rebates and chargebacks, fees and other discounts require subjective and complex judgments due to the need to make estimates about matters that are inherently uncertain. Any significant differences between our actual results and our estimates could negatively affect our financial position, results of operations and cash flows. In addition, to determine the required quantities of our products and the related manufacturing schedule, we also need to make significant judgments and estimates based on inventory levels, current market trends, anticipated sales, and other factors. Because of the inherent nature of estimates, there could be significant differences between our estimates and the actual amount of product need. For example, the level of our access to wholesaler and distributor inventory levels and sales data, which varies based on the wholesaler or distributor, affects our ability to accurately estimate certain reserves included in our financial statements. Any difference between our estimates and the actual amount of product demand could result in unmet demand or excess inventory, each of which would adversely impact our financial results and results of operation.

Our stock price has been and may continue to be volatile, and your investment in our stock could decline in value or fluctuate significantly.

The market price of our common stock has been, and may continue to be, volatile, and your investment in our stock could decline in value or fluctuate significantly. Our stock price has ranged between $31.90 and $58.23 in the fifty-two week period through May 3, 2010. The stock market has from time to time experienced extreme price and volume fluctuations, particularly in the biotechnology and pharmaceuticals sectors, which have often been unrelated to the operating performance of particular companies. Various factors and events, many of which are beyond our control, may have a significant impact on the market price of our common stock. Factors which may affect the market price of our common stock include, among others:

· Our ability to successfully commercialize Feraheme in the U.S.;

· The timing and magnitude of Feraheme revenue and actual or anticipated fluctuations in our operating results;

· Changes in or our failure to meet financial estimates published by securities analysts;

· The availability of reimbursement coverage for Feraheme or changes in the reimbursement policies of governmental or private payors;

· Public announcements of regulatory actions with respect to Feraheme or products or product candidates of our competitors;

· Actual or perceived safety concerns related to Feraheme or products or product candidates of our competitors;

· General market conditions;

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· Sales of large blocks of our common stock;

· The status or results of clinical trials for Feraheme or products or product candidates of our competitors;

· The acquisition or development of technologies, product candidates or products by us or our competitors;

· Developments in patents or other proprietary rights by us or our competitors;

· The outcome of any material litigation to which we are a party; and

· Significant collaboration, acquisition, joint venture or similar agreements by us or our competitors.

Thus, as a result of events both within and beyond our control, our stock price could fluctuate significantly or lose value rapidly.

If securities analysts downgrade our stock, cease coverage of us, or if our operating results do not meet analysts’ forecasts and expectations, our stock price could decline.

The trading market for our common stock relies in part on the research and reports that industry or financial analysts publish about us and our business. Currently, ten financial analysts publish reports about us and our business. We do not control these or any other analysts. Furthermore, there are many large, well-established, publicly traded companies active in our industry and market, which may mean that it is less likely that we will receive widespread analyst coverage. In addition, our future operating results are subject to substantial uncertainty, and our stock price could decline significantly if we fail to meet or exceed analysts’ forecasts and expectations, especially with respect to the timing and magnitude of Feraheme revenues, including the recognition of net product revenues associated with purchases made under our Launch Incentive Program, which were initially deferred as of September 30, 2009. If any of the analysts who cover us downgrade our stock or issue commentary or observations that are perceived by the market to be adverse to us or our stock, our stock price would likely decline rapidly. If these analysts cease coverage of our company, we could lose visibility in the market, which in turn could cause our stock price to decline.

We have a history of net losses, and we may not be able to generate sufficient revenues to achieve and maintain profitability in the future.

We have a history of significant operating losses, and we may not be profitable in the future or if we attain profitability, it may not be sustainable. In the past, we have financed our operations primarily from the sale of our equity securities, cash generated by our investing activities, and payments from our strategic partners. As of March 31, 2010, we had an accumulated deficit of approximately $304.7 million. Our losses are primarily the result of costs incurred in research and development, including costs associated with our Feraheme and other development programs, costs associated with establishing and maintaining our sales and marketing infrastructure, and other selling, general and administrative costs. We expect to continue to incur significant expenses to manufacture, market and sell Feraheme as an IV iron replacement therapeutic in CKD patients in the U.S. and to further develop Feraheme for additional indications and in additional countries outside of the U.S. As a result, we will need to generate sufficient revenues in future periods to achieve and maintain profitability. We anticipate that the vast majority of any revenue we generate in the near future will be from sales of Feraheme as an IV iron replacement therapeutic agent for CKD patients in the U.S. We have never independently marketed or sold any products, and we may not be successful in marketing or selling Feraheme . If we are not successful in marketing and selling Feraheme , if revenues grow more slowly than we anticipate or if our operating expenses exceed our expectations, our business,

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results of operations and financial condition could be materially adversely affected. In addition, if we are unable to achieve, maintain or increase profitability on a quarterly or annual basis, the market price of our common stock may decline.

We may need additional capital to achieve our business objectives.

We have expended and will continue to expend substantial funds to successfully commercialize and develop Feraheme . As a result, we anticipate that our expenses will increase and that our cash-burn rate will continue to increase in the near- and long-term. Our long-term capital requirements will depend on many factors, including, but not limited to:

· The magnitude of Feraheme sales and the timing of our receipt of cash from such sales;

· Our ability to achieve the various milestones and receive the associated payments under the Takeda Agreement;

· Costs associated with the U.S. commercialization of Feraheme , including costs associated with maintaining our commercial infrastructure and distribution network and executing our promotional and marketing strategy for Feraheme ;

· Costs associated with our development of additional indications for Feraheme in the U.S.;

· Costs associated with our pursuit of approval for Feraheme as an IV iron replacement therapeutic agent outside of the U.S.;

· Costs associated with potential business development and in-licensing activities;

· Our ability to liquidate our investments in a timely manner and without significant loss;

· The impact of the current state of the credit and capital markets upon the investments in our portfolio;

· Our ability to maintain successful collaborations with our partners and/or to enter into additional alternative strategic relationships, if necessary; and

· Our ability to raise additional capital on terms and within a timeframe acceptable to us, if necessary.

We estimate that our cash resources at March 31, 2010, combined with the $60.0 million upfront payment we received from Takeda in April 2010, cash we currently expect to receive from sales of Feraheme and from earnings on our investments, will be sufficient to finance our currently planned operations for at least the next twelve months. Thereafter, we may require additional funds or need to establish additional alternative strategic arrangements to execute our business plans. We may seek needed funding through additional arrangements with collaborative partners or through public or private equity or debt financings. We may not be able to obtain financing or to secure alternative strategic arrangements on acceptable terms or within an acceptable timeframe, if at all.

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Any additional equity financings or alternative strategic arrangements would be dilutive to our stockholders. In addition, the terms of any debt financing could greatly restrict our ability to raise additional capital and may provide rights and preferences to the investors in any such financing which are not available to current stockholders. Our inability to raise additional capital on terms and within a timeframe acceptable to us when needed could force us to dramatically reduce our expenses and delay, scale back or eliminate certain of our activities and operations, including our commercialization and development activities, any of which would have a material adverse effect on our business, financial condition and future business prospects.

The investment of our cash is subject to risks, which may cause losses or adversely affect the liquidity of these investments.

At March 31, 2010, we had $212.7 million in cash and cash equivalents, $21.0 million in short-term investments, $48.4 million in long-term investments, and $0.8 million in Settlement Rights with respect to certain of our auction rate securities, or ARS. These investments are subject to general credit, liquidity, market and interest rate risks, which have been and may continue to be exacerbated by the U.S. sub-prime mortgage defaults and the ensuing fallout. The recent disruptions in the credit and financial markets have negatively affected many industries, including those in which we invest, and we may realize losses in the fair value of certain of our investments or a complete loss of these investments, which would have an adverse effect on our results of operations, liquidity and financial condition.

At March 31, 2010, we held a total of $56.9 million in fair market value of ARS, reflecting a decline in value of approximately $8.0 million compared to the par value of these securities of $64.9 million. Of the $8.0 million decline in value, approximately $7.2 million was considered a temporary impairment and was reported as an unrealized loss in accumulated other comprehensive loss at March 31, 2010. The remaining $0.8 million represented a trading loss which was recognized in our consolidated statements of operations. In February 2008, our ARS began to experience failed auctions and have continued to experience failed auctions. Since that time, the continued uncertainty in the credit markets has caused almost all additional auctions with respect to our ARS to fail and prevented us from liquidating certain of our holdings of ARS because the amount of these securities submitted for sale has exceeded the amount of purchase orders for these securities. These auctions may continue to fail indefinitely, and there could be a further decline in value of these securities or any other securities, which may ultimately be deemed to be other-than-temporary. In the future, should we determine that these declines in value of ARS are other-than-temporary, we will recognize the credit-related portion of the loss to our consolidated statement of operations, which could be material. In addition, failed auctions will adversely impact the liquidity of our investments. Based on our ability to access our cash and other short-term investments, our expected operating cash flows, and our other sources of cash, we do not anticipate that the current lack of liquidity with respect to these securities will materially affect our ability to operate our business in the ordinary course in the short term, however, we are uncertain when the current liquidity issues relating to ARS will improve, if at all.

The condition of the credit markets remains dynamic and unpredictable. As a result, we may experience a reduction in value or loss of liquidity with respect to our investments. In addition, should our investments cease paying or reduce the amount of interest paid to us, our interest income would suffer. Further, as part of our determination of the fair value of our investments, we consider credit ratings provided by independent investment rating agencies as of the valuation date. These ratings are subject to change. For example, in February 2009 three of our ARS with a total par value of $8.7 million and one of our ARS with a par value of $5.0 million were downgraded by one of the major credit rating agencies to A3 and Baa1, respectively, from their previous rating of Aaa. In contrast, the ARS having a par a value of $5.0 million was re-affirmed as AAA by a different major rating agency in January 2009. As the ratings

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of our ARS change we may be required to adjust our future valuation of our ARS which may adversely affect the value of these investments. These market risks associated with our investment portfolio may have an adverse effect on our results of operations, cash position, liquidity and overall financial condition.

Our ability to use net operating loss carryforwards and tax credit carryforwards to offset future taxable income may be limited as a result of the sale of shares of our common stock in our January 2010 public offering or other past or future transactions involving our common stock.

In general, under Section 382 of the Internal Revenue Code of 1986, as amended, a corporation that undergoes an ‘‘ownership change’’ is subject to limitations on its ability to utilize its pre-change net operating losses and certain other tax assets to offset future taxable income. In general, an ownership change occurs if the aggregate stock ownership of certain stockholders increases by more than 50 percentage points over such stockholders’ lowest percentage ownership during the testing period, which is generally three years. An ownership change could limit our ability to utilize our net operating loss and tax credit carryforwards for taxable years including or following such ‘‘ownership change.’’ It is possible that the issuance of shares of our common stock in our January 2010 public offering, together with certain other transactions involving our common stock within the testing period, will result in an ownership change. Even if the issuance of our common stock in our recent offering does not result in an ownership change, this offering would significantly increase the likelihood that there would be an ownership change in the future (which ownership change could occur as a result of transactions involving our common stock that are outside of our control, such as sales by existing stockholders). Limitations imposed on the ability to use net operating losses and tax credits to offset future taxable income could require us to pay U.S. federal income taxes earlier than we have estimated would otherwise be required if such limitations were not in effect and could cause such net operating losses and tax credits to expire unused, in each case reducing or eliminating the benefit of such net operating losses and tax credits and potentially adversely affecting our financial position. Similar rules and limitations may apply for state income tax purposes.

The current credit and financial market conditions may exacerbate certain risks affecting our business.

Over the past two years, the U.S. and global economies have taken a dramatic downturn as a result of the volatility of the credit markets and related financial crisis, as well as a variety of other factors including, among other things, extreme volatility in security prices, severely diminished liquidity and credit availability, ratings downgrades of certain investments and declining valuations of others. The U.S. and certain foreign governments have taken unprecedented actions in an attempt to address and rectify these extreme market and economic conditions by providing liquidity and stability to the financial markets. If the actions taken by the U.S. and other governments are not successful, the continued economic decline may continue to negatively affect the liquidity of our investments, significantly impact our ability to raise capital, if needed, on a timely basis and on acceptable terms or at all, and cause our investments to substantially decline in value. Any of these could have a material adverse effect on our liquidity, cash position and the potential future prospects of our business.

In addition, we rely and intend to continue to rely on third-parties, including clinical research organizations, third-party manufacturers, third-party logistics providers, packaging and labeling providers, wholesale distributors and certain other important vendors and consultants. As a result of the current volatile and unpredictable global economic situation, there may be a disruption or delay in the performance or satisfaction of commitments to us by our third-party contractors and suppliers. For example, as a result of the current economic climate, our distributors, customers or suppliers may experience difficulty in obtaining the liquidity necessary to purchase inventory or raw materials, may begin to maintain lower inventory levels or could become insolvent. If such third-parties are unable to adequately satisfy their contractual commitments to us in a timely manner, our business could be severely adversely affected.

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If we fail to comply with our reporting and payment obligations under governmental pricing programs, we could be required to reimburse government programs for underpayments and could be required to pay penalties, sanctions and fines which could have a material adverse effect on our business, financial condition and results of operation.

As a condition of reimbursement by various federal and state healthcare programs, we are required to calculate and report certain pricing information to federal and state healthcare agencies. For example, we are required to provide ASP information to CMS on a quarterly basis in order to compute Medicare payment rates. Price reporting and payment obligations are highly complex and vary among products and programs. Our processes for estimating amounts due under these governmental pricing programs involve subjective decisions, and as a result, our price reporting calculations remain subject to the risk of errors and our methodologies for calculating these prices could be challenged under the Federal False Claims Act or other laws. If we become subject to investigations or other inquiries concerning our compliance with price reporting laws and regulations, we could be required to pay or be subject to additional reimbursements, penalties, sanctions or fines, which could have a material adverse effect on our business, financial condition and results of operation.

We are subject to ongoing regulatory review of Feraheme, and if we fail to comply with such continuing regulations, we could be subject to penalties up to and including the suspension of the manufacturing, marketing and sale of Feraheme.

We are subject to ongoing FDA regulatory requirements and review pertaining to Feraheme’s manufacture, labeling, packaging, adverse event reporting, storage, advertising, promotion and record keeping. Failure to comply with such regulatory requirements or the later discovery of previously unknown problems with Feraheme or our manufacturing facility may result in restrictions on our ability to market and sell Feraheme , including its withdrawal from the market. We may also be subject to additional sanctions, including but not limited to:

· FDA Warning Letters;

· Civil or criminal penalties;

· Suspension or withdrawal of regulatory approvals;

· Temporary or permanent closing of our manufacturing facilities;

· Requirements to communicate with physicians and other customers about concerns related to actual or potential safety, efficacy, or other issues involving Feraheme;

· FDA-imposed label changes;

· Implementation of an FDA-mandated REMS;

· Restrictions on our continued manufacturing, marketing or sale of Feraheme; or

· Recalls or a refusal by the FDA to consider or approve applications for additional indications.

Any of these sanctions would have a material adverse impact on our ability to generate revenues and to achieve profitability.

If we market or distribute our products in a manner that violates federal or state healthcare fraud and abuse laws, marketing disclosure laws or other federal or state laws and regulations, we may be subject to civil or criminal penalties.

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In addition to FDA and related regulatory requirements, we are subject to extensive federal and state healthcare regulation, including but not limited to, the federal false claims act and the federal anti-kickback statute. False claims laws prohibit anyone from knowingly presenting, or causing to be presented for payment to third-party payors, including Medicare and Medicaid, false or fraudulent claims for reimbursed drugs or services, claims for items or services not provided as claimed, or claims for medically unnecessary items or services. Anti-kickback laws make it illegal to solicit, offer, receive or pay any remuneration in exchange for, or to induce, the referral of business, including the purchase or prescription of a particular drug, that is reimbursed by a state or federal program. We have developed and implemented a corporate compliance program based on what we believe are current best practices in the pharmaceutical industry, but we cannot guarantee that we, our employees, our consultants or our contractors are or will be in compliance with all federal and state regulations and/or laws. If we or our representatives fail to comply with any of these laws or regulations, a range of fines, penalties and/or other sanctions could be imposed on us, including, but not limited to, restrictions on how we market and sell Feraheme , significant fines, exclusions from government healthcare programs, including Medicare and Medicaid, litigation, or other sanctions. Even if we are not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative publicity, which could also have an adverse effect on our business, financial condition and results of operation.

In recent years, several states and localities have enacted legislation requiring pharmaceutical companies to establish marketing and promotional compliance programs or codes of conduct and/or file periodic reports with the state or make periodic public disclosures on sales, marketing, pricing, clinical trials, and other activities. Similar legislation is being considered by additional states and by Congress. Many of these requirements are new and uncertain, and the penalties for failure to comply with these requirements are unclear. Compliance with these laws is difficult and time consuming, and if we are found to not be in full compliance with these laws, we may face enforcement actions, fines and other penalties, and we could receive adverse publicity which could have an adverse effect on our business, financial condition and results of operation.

If we fail to comply with any federal or state laws or regulations governing our industry, we could be subject to a range of regulatory actions that could adversely affect our ability to commercialize Feraheme , harm or prevent sales of Feraheme , or substantially increase the costs and expenses of commercializing and marketing Feraheme, all of which could have a material adverse effect on our business, financial condition and results of operation.

We may enter into collaborations, in-licensing arrangements, or acquisition agreements that could disrupt our business, decrease our profitability, result in dilution to stockholders or cause us to incur debt or significant additional expense.

As part of our business strategy, we intend to pursue collaboration and in-licensing opportunities, acquisitions of products or businesses, and/or strategic alliances that we believe would be complementary to our existing business. We have limited experience with respect to these business development activities. Any such strategic transactions by us could result in large and immediate write-offs or the incurrence of debt and contingent liabilities, any of which would adversely impact our operating results. Management of a license arrangement, collaboration, or other strategic arrangement and/or integration of an acquired asset or company may also disrupt our ongoing business, require management resources that otherwise would be available for ongoing development of our existing business and our U.S. commercialization of Feraheme . We may not identify or complete any such transactions in a timely manner, on a cost-effective basis, or at all, and we may not realize the anticipated financial benefits of any such transaction. In addition, to finance any such strategic transactions, we may choose to issue shares of our common or preferred stock as consideration, which would result in dilution to our stockholders. Alternatively, it may be necessary for us

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to raise additional funds through public or private financings, and such additional funds may not be available on terms that are favorable to us, if at all. In addition, proposing, negotiating and implementing collaborations, in-licensing arrangements or acquisition agreements may be a lengthy and complex process. Other companies, including those with substantially greater financial, marketing and sales resources, may compete with us for these arrangements, and we may not be able to enter into such arrangements on acceptable terms or at all.

If we do not effectively manage our growth, our ability to commercialize Feraheme, pursue opportunities and expand our business could be adversely affected .

We have experienced significant growth, which has placed and may continue to place a substantial strain on our management, employees, facilities and resources. In anticipation of the approval and U.S. commercialization of Feraheme , we rapidly expanded our marketing, sales, manufacturing, regulatory, medical affairs, finance, development, and compliance capabilities. As our operations continue to expand, we will also need to manage additional relationships with various collaborative partners, suppliers and other third parties. In addition, we will need to continue to improve our operational and financial systems, train and manage our expanding workforce, and maintain close coordination among our various departments. We may not be able to accomplish these tasks, and our failure to accomplish any one of them could prevent us from successfully commercializing Feraheme , pursuing new business opportunities, or expanding our business, any one of which could adversely impact our future business prospects.

Our success depends on our ability to attract and retain key employees.

Because of the specialized nature of our business, our success depends to a significant extent on the continued service of our Chief Executive Officer and President, Brian J.G. Pereira, MD, our other executive officers and on our ability to continue to attract, retain and motivate qualified managerial, scientific, medical and sales personnel. We have entered into employment agreements with our senior executives but such agreements do not guarantee that these executives will remain employed by us for any significant period of time, or at all. If we are unable to retain these personnel, or we lose the services of our key personnel for any reason, our Feraheme development and commercialization efforts could be adversely impacted.

Furthermore, our expansion into areas and activities requiring additional expertise, such as commercial-scale manufacturing, marketing and sales, and late-stage development has required the addition of new management personnel and the development of additional expertise by existing management personnel. There is intense competition for qualified personnel in the areas of our activities, and we may not be able to continue to attract and retain the qualified personnel necessary for the development of our business. Our failure to attract and retain such personnel or to develop such expertise could impose significant limits on our business operations and hinder our ability to successfully and efficiently commercialize Feraheme and complete our development projects.

Our success depends on our ability to maintain the proprietary nature of our technology.

We rely on a combination of patents, trademarks, copyrights and trade secrets in the conduct of our business. The patent positions of pharmaceutical and biopharmaceutical firms are generally uncertain and involve complex legal and factual questions. We may not be successful or timely in obtaining any patents for which we submit applications. The breadth of the claims obtained in our patents may not provide significant protection for our technology. The degree of protection afforded by patents for licensed technologies or for future discoveries may not be adequate to protect our proprietary technology. The patents issued to us may not provide us with any competitive advantage. In addition, there is a risk that

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others will independently develop or duplicate similar technology or products or circumvent the patents issued to us.

Our U.S. Feraheme patents are currently scheduled to expire in 2020. These and any other patents issued to us may be contested or invalidated. Future patent interference proceedings involving our patents may harm our ability to commercialize Feraheme . Claims of infringement or violation of the proprietary rights of others may be asserted against us. If we are required to defend against such claims or to protect our own proprietary rights against others, it could result in substantial costs to us and the distraction of our management. An adverse ruling in any litigation or administrative proceeding could prevent us from marketing and selling Feraheme , limit our development and commercialization of Feraheme , or harm our competitive position and result in additional significant costs. In addition, any successful claim of infringement asserted against us could subject us to monetary damages or injunction preventing us from making or selling Feraheme . We also may be required to obtain licenses to use the relevant technology. Such licenses may not be available on commercially reasonable terms, if at all.

The laws of foreign countries may not protect our intellectual property rights to the same extent as do the laws of the U.S. In countries where we do not have or have not applied for patents on Feraheme , we may be unable to prevent others from developing or selling similar products. In addition, in jurisdictions outside the U.S. where we have patent rights, we may be unable to prevent unlicensed parties from selling or importing products or technologies derived elsewhere using our proprietary technology.

We also rely upon unpatented trade secrets and improvements, unpatented know-how and continuing technological innovation to develop and maintain our competitive position, which we seek to protect, in part, by confidentiality agreements with our corporate partners, collaborators, employees and consultants. These agreements, however, may be breached. We may not have adequate remedies for any such breaches, and our trade secrets might otherwise become known or might be independently discovered by our competitors. In addition, we cannot be certain that others will not independently develop substantially equivalent or superseding proprietary technology, or that an equivalent product will not be marketed in competition with Feraheme , thereby substantially reducing the value of our proprietary rights.

If we identify a material weakness in our internal controls over financial reporting, our ability to meet our reporting obligations and the trading price of our stock could be negatively affected.

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. Accordingly, a material weakness increases the risk that the financial information we report contains material errors.

We regularly review and update our internal controls, disclosure controls and procedures, and corporate governance policies. In addition, we are required under the Sarbanes-Oxley Act of 2002 to report annually on our internal control over financial reporting. Any system of internal controls, however well designed and operated, is based in part on certain assumptions and can provide only reasonable, not absolute, assurances that the objectives of the system are met. If we, or our independent registered accounting firm, determine that our internal controls over our financial reporting are not effective, or we discover areas that need improvement in the future, these shortcomings could have an adverse effect on our business and financial results, and the price of our common stock could be negatively affected.

If we cannot conclude that we have effective internal control over our financial reporting, or if our independent registered accounting firm is unable to provide an unqualified opinion regarding the effectiveness of our internal control over financial reporting, investors could lose confidence in the

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reliability of our financial statements, which could lead to a decline in our stock price. Failure to comply with reporting requirements could also subject us to sanctions and/or investigations by the Securities and Exchange Commission, NASDAQ or other regulatory authorities.

An adverse determination, if any, in the class action lawsuit in which we are a defendant could have a material adverse affect on us.

A purported class action complaint was filed on March 18, 2010 in the United States District Court for the District of Massachusetts against us and our President and Chief Executive Officer, and Executive Vice President and Chief Financial Officer, entitled Silverstrand Investments v. AMAG Pharm., Inc., et. al. , Civil Action No. 1:10-CV-10470-NMG. The complaint alleges that the defendants violated the federal securities laws, specifically Section 11 of the Securities Act of 1933, as amended, by making certain alleged false and misleading statements and omissions in our registration statement filed in January 2010. The plaintiff seeks unspecified damages on behalf of a purported class of purchasers of our common stock pursuant to our common stock offering on or about January 21, 2010. We believe that the allegations contained in the complaint are without merit and intend to defend the case vigorously. However, whether or not the plaintiff’s claims are successful, this type of litigation is often expensive and diverts management’s attention and resources, which could adversely affect the operation of our business. If we are ultimately required to pay significant defense costs, damages or settlement amounts, such payments could adversely affect our operations. We maintain liability insurance, however, if any costs or expenses associated with this litigation exceed the insurance coverage, we may be forced to bear some or all of these costs and expenses directly, which could be substantial.

We are exposed to a number of different potential liability claims.

The administration of our products to humans, whether in clinical trials or after approved commercial usage, may expose us to liability claims. Although we maintain product liability insurance coverage for claims arising from the use of our products in clinical trials and commercial use, coverage is expensive and we may not be able to maintain sufficient insurance at a reasonable cost, if at all. Product liability claims, whether or not they have merit, could decrease demand for Feraheme , subject us to product recalls or harm our reputation, all of which could damage our position in the stock market at a time when the market in general has experienced extreme price and volume fluctuations.

Further, the market prices of securities of companies in the biopharmaceutical industry have been extremely volatile and have experienced fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. These fluctuations could adversely affect the market price of our common stock. In the past, securities class action litigation has often been brought against companies following periods of volatility in the market prices of their securities. For example, a purported class action complaint was filed on March 18, 2010 against us and our President and Chief Executive Officer, and Executive Vice President and Chief Financial Officer alleging that the defendants violated the federal securities laws, specifically Section 11 of the Securities Act of 1933, as amended, by making certain alleged false and misleading statements and omissions in our registration statement filed in January 2010. We may be the target of similar litigation in the future. Securities litigation could result in substantial costs and divert our management’s attention and resources, which could cause serious harm to our business, operating results and financial condition.

Our shareholder rights plan, certain provisions in our charter and by-laws, certain contractual relationships and certain Delaware law provisions could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders, and may prevent attempts by our stockholders to replace or remove our current members of our Board of Directors.

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In 2009 we adopted a shareholder rights plan, the provisions of which are intended to deter a hostile takeover by making any proposed hostile acquisition of us more expensive and less desirable to a potential acquirer by enabling our shareholders (other than the potential hostile acquiror) to purchase significant amounts of additional shares of our common stock at dilutive prices. The rights issued pursuant to our shareholder rights plan become exercisable generally upon the earlier of 10 days after a person or group acquires 20% or more of our outstanding common stock or 10 business days after the announcement by a person or group of an intention to acquire 20% of our outstanding common stock via tender offer or similar transaction. The shareholder rights plan could delay or discourage transactions involving an actual or potential change in control of us or our management, including transactions in which stockholders might otherwise receive a premium for their shares over then current prices.

In addition, certain provisions in our certificate of incorporation and our by-laws may discourage, delay or prevent a change of control or takeover attempt of our company by a third-party as well as substantially impede the ability of our stockholders to benefit from a change of control or effect a change in management and board of directors. These provisions include:

· The ability of our Board of Directors to increase or decrease the size of the Board without stockholder approval;

· Advance notice requirements for the nomination of candidates for election to our Board of Directors and for proposals to be brought before our annual meeting of stockholders;

· The authority of our Board of Directors to designate the terms of and issue new series of preferred stock without stockholder approval;

· Non-cumulative voting for directors; and

· Limitations on the ability of our stockholders to call special meetings of stockholders.

As a Delaware corporation, we are subject to the provisions of Section 203 of the Delaware General Corporation Law which prevents us from engaging in any business combination with any “interested stockholder,” which is defined generally as a person that acquires 15% or more of a corporation’s outstanding voting stock, 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. These provisions could have the effect of delaying or preventing a change of control, whether or not it is desired by, or beneficial to, our stockholders.

In addition to the above factors, an acquisition of our company could be made more difficult by employment agreements we have in place with our executive officers, as well as a company-wide change of control policy which provide for severance benefits as well as the full acceleration of vesting of any outstanding options or restricted stock units in the event of a change of control and subsequent termination of employment. Further, our Amended and Restated 2007 Equity Incentive Plan generally permits our Board of Directors to provide for the acceleration of vesting of options granted under that plan in the event of certain transactions that result in a change of control.

We are subject to environmental laws and potential exposure to environmental liabilities.

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Because we use certain hazardous materials in the production of our products, we are subject to various federal, state and local environmental laws and regulations that govern our operations, including the import, handling and disposal of non-hazardous and hazardous wastes, and emissions and discharges into the environment. Failure to comply with these laws and regulations could result in costs for corrective action, penalties or the imposition of other liabilities. We also are subject to laws and regulations that impose liability and clean-up responsibility for releases of hazardous substances into the environment. Under certain of these laws and regulations, a current or previous owner or operator of property may be liable for the costs of remediating the release or spill of hazardous substances or petroleum products on or from its property, without regard to whether the owner or operator knew of, or caused, the contamination, and such owner or operator may incur liability to third parties impacted by such contamination. The presence of, or failure to remediate properly the release or spill of, these substances could adversely affect the value of, and our ability to transfer or encumber, our real property.

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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

There were no purchases by us, or any affiliated purchaser, of our equity securities which are registered pursuant to Section 12 of the Exchange Act during the three months ended March 31, 2010.

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Item 6. Exhibits.

(a) List of Exhibits

Exhibit Number		Description

3.1, 4.1	+	Restated Certificate of Amendment of the Company.
10.1	+	License, Development and Commercialization Agreement by and between AMAG Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited, dated March 31, 2010 (portions of this exhibit have been omitted and filed separately with the Commission pursuant to a request for confidential treatment).
31.1	+	Certification Pursuant to Rule 13a-14(a)/15d-14(a) of the Exchange Act, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2	+	Certification Pursuant to Rule 13a-14(a)/15d-14(a) of the Exchange Act, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1	++	Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2	++	Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

+ Exhibits marked with a plus sign (“+”) are filed herewith.

++ Exhibits marked with a double plus sign (“++”) are furnished herewith.

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SIGNATURES

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	AMAG PHARMACEUTICALS, INC.


	By:	/s/ Brian J.G. Pereira
		Brian J.G. Pereira,
		Chief Executive Officer and President

	Date: May 6, 2010

	AMAG PHARMACEUTICALS, INC.


	By:	/s/ David A. Arkowitz
		David A. Arkowitz,
		Executive Vice President, Chief Financial Officer and Chief Business Officer

	Date: May 6, 2010

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EXHIBIT INDEX

Exhibit Number		Description

3.1, 4.1	+	Restated Certificate of Amendment of the Company.
10.1	+	License, Development and Commercialization Agreement by and between AMAG Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited, dated March 31, 2010 (portions of this exhibit have been omitted and filed separately with the Commission pursuant to a request for confidential treatment).
31.1	+	Certification Pursuant to Rule 13a-14(a)/15d-14(a) of the Exchange Act, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2	+	Certification Pursuant to Rule 13a-14(a)/15d-14(a) of the Exchange Act, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1	++	Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2	++	Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

+ Exhibits marked with a plus sign (“+”) are filed herewith.

++ Exhibits marked with a double plus sign (“++”) are furnished herewith.

EXHIBIT 3.1, 4.1

RESTATED CERTIFICATE OF INCORPORATION

AMAG PHARMACEUTICALS, INC.

(Pursuant to Section 245 of the
General Corporation Law of the State of Delaware)

AMAG PHARMACEUTICALS, INC. , a corporation organized and existing under and by virtue of the provisions of the General Corporation Law of the State of Delaware (the “ General Corporation Law ”),

DOES HEREBY CERTIFY:

1. That the name of this corporation is AMAG Pharmaceuticals, Inc., and that this corporation was originally incorporated pursuant to the General Corporation Law on November 9, 1981 under the name BioClinical Group, Inc.

2. That this corporation filed with the Secretary of State of the State of Delaware its original certificate of incorporation on November 9, 1981 (the “ Original Certificate ”). The Original Certificate was (a) renewed by that certain Certificate of Renewal on December 13, 1983, (b) amended to change the corporation’s name from “BioClinical Group, Inc.” to “Advanced Magnetics, Inc.” by that certain Certificate of Amendment on December 13, 1983, (c) amended by that certain Certificate of Amendment on April 28, 1986, (d) amended by that certain Certificate of Amendment on February 12, 1987, (e) amended by that certain Certificate of Ownership and Merger on November 30, 1990, (f) amended by that certain Certificate of Amendment on March 10, 1992, (g) amended by that certain Certificate of Amendment on February 8, 2006, (h) amended to change the corporation’s name from “Advanced Magnetics, Inc.” to “AMAG Pharmaceuticals, Inc.” by that certain Certificate of Ownership and Merger on July 24, 2007, (i) amended by that certain Certificate of Amendment on May 7, 2008, and (j) supplemented by that certain Certificate of Designation on September 4, 2009 which designated forty-five thousand (45,000) shares of the Corporation’s Preferred Stock as Series A Junior Participating Preferred Stock, pursuant to section 151(f) of the General Corporation Law, with the rights, preferences, privileges, and restrictions of such shares of Series A Junior Participating Preferred Stock as set forth in EXHIBIT A hereto (such certificate of incorporation, as so amended, renewed and supplemented, the “ Current Certificate of Incorporation ”).

3. The Current Certificate of Incorporation, as so amended and renewed to date, is hereby restated as set forth in this Restated Certificate of Incorporation hereinafter provided for.

4. That this Restated Certificate of Incorporation has been duly adopted in accordance with the provisions of Sections 245 of the General Corporation Law of the State of Delaware and (a) only restates and integrates the provisions of the Current Certificate of Incorporation, (b) does not further amend the provisions of the Current Certificate of Incorporation as heretofore amended, and (c) there are no discrepancies between the provisions of the Current Certificate of Incorporation and the provisions of this Restated Certificate of Incorporation.

5. The Current Certificate of Incorporation, as restated herein, shall at the effective time of this Restated Certificate of Incorporation, read as follows:

FIRST : The name of this corporation is AMAG Pharmaceuticals, Inc. (the “ Corporation ”).

SECOND : The address of its registered office in the State of Delaware is No. 100 West Tenth Street, in the City of Wilmington, County of New Castle. The name of its registered agent at such address is The Corporation Trust Company.

THIRD: The nature of the business or purposes to be conducted or promoted is as follows:

To engage in any lawful act or activity for which corporations may be organized under the General Corporation Law of Delaware.

FOURTH: (A) This Corporation is authorized to issue two classes of stock to be designated, respectively, “Common Stock” and “Preferred Stock.” The total number of shares which the Corporation is authorized to issue is 60,750,000 shares, $.01 par value per share, of which 58,750,000 shares shall be Common Stock and 2,000,000 shares shall be Preferred Stock.

(B) The Preferred Stock may be issued from time to time in one or more series. The Board of Directors of the Corporation is hereby authorized, within the limitation and restrictions stated in this Restated Certificate of Incorporation to determine or alter the rights, preferences, powers, privileges and the restrictions, qualifications and limitation granted to or imposed upon any wholly unissued series of Preferred Stock, and the number of shares constituting any such series and the designation thereof; and to increase or decrease the number of shares constituting any such series; and to increase or decrease the number of shares of any series subsequent to the issue of shares of that series, but not below the number of shares of any series shall be so decreased, the shares then constituting such decrease shall resume the status which they had prior to the adoption of the resolution originally fixing the number of shares of such series. As of September 4, 2009, the Board of Directors of the Corporation has designated forty-five thousand (45,000) shares of the Corporation’s Preferred Stock as Series A Junior Participating Preferred Stock, pursuant to section 151(f) of the Delaware General Corporation Law, with the rights, preferences, privileges, and restrictions of such shares of Series A Junior Participating Preferred Stock as set forth in EXHIBIT A hereto.

FIFTH: In furtherance of and not in limitation of powers conferred by statute, it is further provided:

Election of directors need not be by written ballot.

The Board of Directors is expressly authorized to adopt, amend or repeal the By-Laws of the Corporation.

SIXTH: Whenever a compromise or arrangement is proposed between this Corporation and its creditors or any class of them and/or between this Corporation and its stockholders or any class of them, any court of equitable jurisdiction within the State of Delaware may, on the application in a summary way of this Corporation or of any creditor or stockholder thereof, or on the application of any receiver or receivers appointed for this Corporation under the provisions of section 291 of Title 8 of the Delaware Code or on the application of trustees in dissolution or of any receiver or receivers appointed for this Corporation under the provisions of section 279 of Title 8 of the Delaware Code order a meeting of the creditors or class of creditors, and/or of the stockholders or class of stockholders of this Corporation, as the case may be, to be summoned in such manner as the said court directs. If a majority in number representing three-fourths in value of the creditors or class of creditors, and/or of the stockholders or class of stockholders of this Corporation, as the case may be, agree to any compromise or arrangement and to

any reorganization of this Corporation as consequence of such compromise or arrangement, the said compromise or arrangement and the said reorganization shall, if sanctioned by the court to which the said application has been made, be binding on all the creditors or class of creditors, and/or on all the stockholders or class of stockholders, of this Corporation, as the case may be, also on this Corporation.

SEVENTH: The Corporation shall, to the fullest extent permitted by Section 145 of the General Corporation Law of Delaware, as that Section may be amended and supplemented from time to time, indemnify any director or officer which it shall have power to indemnify under that Section against any expenses, liabilities or other matters referred to in or covered by that Section. The indemnification provided for in this Article (i) shall not be deemed exclusive of any other rights to which those indemnified may be entitled under any by-law, agreement or vote of stockholders or disinterested directors or otherwise, both as to action in their official capacities and as to action in another capacity while holding such office, (ii) shall continue as to a person who has ceased to be a director or officer and (iii) shall inure to the benefit of the heirs, executors and administrators of such a person. To assure indemnification under this Article of all such persons who are determined by the Corporation or otherwise to be or to have been “fiduciaries” of any employee benefit plan of the Corporation which may exist from time to time and which is governed by the Act of Congress entitled “Employee Retirement Income Security Act of 1974,” as amended from time to time, such Section 145 shall, for the purposes of this Article, be interpreted as follows: an “other enterprise” shall be deemed to include such an employee benefit plan; the Corporation shall be deemed to have requested a person to serve an employee benefit plan where the performance by such person of his duties to the Corporation also imposes duties on, or otherwise involves services by, such person to the plan or participants or beneficiaries of the plan; excise taxes assessed on a person with respect to an employee benefit plan pursuant to such Act of Congress shall be deemed “fines;” and action taken or omitted by a person with respect to an employee benefit plan in the performance of such person’s duties for a purpose reasonably believed by such person to be in the interest of the participants and beneficiaries of the plan shall be deemed to be for a purpose which is not opposed to the best interests of the Corporation.

EIGHTH: The Corporation reserves the right to amend, alter, change or deal any provision contained in this Restated Certificate of Incorporation, in the now or hereafter prescribed by statute, and all rights conferred upon stockholders herein are granted subject to this reservation.

NINTH: (A) Each person who was or is made a party or is threatened to be made a party to or is involved in any action, suit or proceeding, whether civil, criminal, administrative or investigative, and whether initiated by or in the right of the Corporation or by a third party (hereinafter a “proceeding”), by reason of the fact that he or she, or a person for whom he or she is the legal representative, is or was a director or officer of the Corporation or is or was serving at the request of the Corporation as a director, officer, employee or agent of another corporation or of a partnership, joint venture, trust or other enterprise, including service with respect to employee benefit plans, whether the basis of such proceeding is alleged action in an official capacity as a director, officer, employee or agent or n any other capacity while serving as a director, officer, employee or agent, shall be indemnified and held harmless by the Corporation to the fullest extent authorized by the Delaware General Corporation Law, as the same exists or may hereafter by amended (in the case of any such amendment, only to the extent that such amendment either (i) permits the Corporation to provide broader indemnification rights than said law permitted prior to such amendment or (ii) prohibits or limits any of the indemnification rights previously set forth in said law, against all expense, liability and loss (including attorneys’ fees, judgments, fines, ERISA excise taxes or penalties and amounts paid or to be paid in settlement) reasonably incurred or suffered by such person in connection therewith and such indemnification shall continue as to a person who has ceased to be a director, officer, employee or agent and shall inure to the benefit of his or her heirs, executors and administrators; provided , however , that, except with respect to a proceeding under paragraph (C) hereof, the Corporation shall indemnify any such person seeking indemnification in connection with a proceeding

(or part thereof) initiated by such person only if such proceeding (or part thereof) was authorized by the Board of Directors of the Corporation. The right to indemnification conferred in this Article shall include the right to be paid by the Corporation the expenses incurred in defending any such proceeding in advance of its final disposition; provided , however , that the payment of such expenses incurred by a director or officer in advance of the final disposition of a proceeding shall be made only upon delivery to the Corporation of an undertaking, by or on behalf of such director or officer, to repay all amounts so advanced if it shall ultimately be determined that such director or officer is not entitled to be indemnified that such director or officer is not entitled to be indemnified under this Article or otherwise. The Corporation may, by action of its Board of Directors, provide indemnification to employees and agents of the Corporation with the same scope and effect as the foregoing indemnification of directors and officers.

(B) Indemnification or advancement of expenses pursuant to paragraph (A) of this Article shall be made no later than 45 days after receipt by the Corporation of the written request of the claimant, unless a determination is made that the claimant has not met the applicable standard of conduct set forth in the Delaware General Corporation Law. Any such determination shall be made (1) by the Board of Directors of the Corporation by a majority vote of a quorum consisting of directors who are not parties to such proceeding, or (2) if such a quorum is not obtainable or, even if obtainable a majority of disinterested directors so directs, by independent legal counsel in a written opinion.

(C) If a claim under paragraph (A) of this Article is not paid in full by the Corporation within the 45-day period specified in paragraph (B), the claimant may at any time thereafter bring suit against the Corporation to recover the unpaid amount of the claim and, if successful in whole or in part, the claimant shall be entitled to be paid also the expense of prosecuting such claim. It shall be a defense to any such action (other than an action brought to force a claim for expenses incurred in defending any proceeding in advance of the final disposition where the required undertaking, if any is required, has been tendered to the Corporation) that the claimant has not met the standards of conduct which make it permissible under the Delaware General Corporation Law for the Corporation to indemnify the claimant for the amount claimed, but the burden of proving such defense shall be on the Corporation. Neither the failure of the Corporation (including its Board of Directors, independent legal counsel, or its stockholders) to have made a determination prior to the commencement of such action that indemnification of the claimant is proper in the circumstances because he or she has met the applicable standard of conduct set forth in the Delaware General Corporation Law, nor an actual determination by the Corporation including its Board of Directors, independent legal counsel, or its stockholders) that the claimant has not met such applicable standard of conduct, shall be a defense to the action or create a presumption that the claimant has not met the applicable standard of conduct.

(D) If a claimant is entitled under any provision of this Article to indemnification by the Corporation for some or a portion of the expenses, judgments, fines or penalties actually and reasonably incurred by him in the investigation, defense, appeal or settlement of any proceeding but not, however, for the total amount thereof, the Corporation shall nevertheless indemnify the claimant for the portion of such expenses, judgments, fines or penalties to which such claimant is entitled.

(E) The right to indemnification and the payment of expenses incurred in defending a proceeding in advance of its final disposition conferred in this Article shall not be exclusive of any other right which any person may have or hereafter acquire under any statute, provision of the Certificate of Incorporation, by-law, agreement, vote of stockholders or disinterested directors or otherwise. Without limiting the generality of the foregoing, the Corporation, acting through its Board of Directors, may enter into agreements with any director, officer, employee or agent of the Corporation providing for indemnification rights equivalent to or greater than the indemnification rights set forth in this Article.

(F) The Corporation may purchase and maintain insurance, at its expense, to protect itself and any director, officer, employee or agent of the Corporation or another corporation, partnership, joint venture, trust or other enterprise against any expense, liability or loss incurred by him in any such Corporation would have the power to indemnify such person against such expense, liability or loss under the Delaware General Corporation Law.

(G) Without the consent of a person entitled to the indemnification and other rights provided in this Article (unless otherwise required by the Delaware General Corporation Law), no amendment modifying or terminating such rights shall adversely affect such person’s rights with respect to the period prior to such amendment.

(H) If the Corporation is merged into or consolidated with another corporation and the Corporation is not the surviving corporation, or if substantially all of the assets or stock of the Corporation is acquired by any other corporation, or in the event of any other similar reorganization involving the Corporation, the Board of Directors of the Corporation or the board of directors of any corporation assuming the obligations of the Corporation shall assume the obligations of the Corporation under this Article, through the date of such merger, consolidation or reorganization, with respect to each person who was entitled to indemnification rights under this Article as of such date.

TENTH: To the fullest extent permitted by Delaware law, as it may be amended from time to time, a director of the Corporation shall not be liable to any Corporation or its stockholders for monetary damages for breach of fiduciary as a director.

IN WITNESS WHEREOF , this Restated Certificate of Incorporation has been executed by a duly authorized officer of this corporation on this day of April, 2010.

	AMAG PHARMACEUTICALS, INC.


	By:	/s/ Joseph L. Farmer
		Joseph L. Farmer
		General Counsel, Senior Vice President of Legal Affairs and Secretary

EXHIBIT A

AMAG PHARMACEUTICALS, INC.

CERTIFICATE OF DESIGNATION

SERIES A JUNIOR PARTICIPATING PREFERRED STOCK

(Pursuant to Section 151 of the

Delaware General Corporation Law)

AMAG PHARMACEUTICALS, INC., a corporation organized and existing under the General Corporation Law of the State of Delaware (hereinafter called the “ Company ”), hereby certifies that the following resolution was adopted by the Board of Directors of the Corporation as required by Section 151 of the General Corporation Law at a meeting duly called and held on September 3, 2009:

RESOLVED, that pursuant to the authority granted to and vested in the Board of Directors of the Company in accordance with the provisions of its Certificate of Incorporation, as amended, the Board of Directors hereby creates a series of Preferred Stock, par value $0.01 per share, of the Company and hereby states the designation and number of shares, and fixes the relative designations and the powers, preferences and rights, and the qualifications, limitations and restrictions thereof (in addition to the provisions set forth in the Certificate of Incorporation of the Company, which are applicable to the Preferred Stock of all classes and series), as follows:

Series A Junior Participating Preferred Stock:

Section 1. Designation and Amount. Forty-Five Thousand (45,000) shares of Preferred Stock, par value $0.01 per share, are designated “ Series A Junior Participating Preferred Stock ” with the designations and the powers, preferences and rights, and the qualifications, limitations and restrictions specified herein (the “ Junior Preferred Stock ”). Such number of shares may be increased or decreased by resolution of the Board of Directors; provided, that no decrease shall reduce the number of shares of Junior Preferred Stock to a number less than the number of shares then outstanding plus the number of shares reserved for issuance upon the exercise of outstanding options, rights or warrants or upon the conversion of any outstanding securities issued by the Company convertible into Junior Preferred Stock.

Section 2. Dividends and Distributions.

(A) Subject to the rights of the holders of any shares of any series of Preferred Stock (or any similar stock) ranking prior and superior to the Junior Preferred Stock with respect to dividends, the holders of shares of Junior Preferred Stock, in preference to the holders of Common Stock, par value $0.01 per share (the “ Common Stock ”), of the Company, and of any other junior stock, shall be entitled to receive, when, as and if declared by the Board of Directors out of funds legally available for the purpose, quarterly dividends payable in cash on the first day of April, July, October and January in each year (each such date being referred to herein as a “ Quarterly Dividend Payment Date ”), commencing on the first Quarterly Dividend Payment Date after the first issuance of a share or fraction of a share of

Junior Preferred Stock, in an amount per share (rounded to the nearest cent) equal to the greater of (a) $l.00 or (b) subject to the provision for adjustment hereinafter set forth, 1,000 times the aggregate per share amount of all cash dividends, and 1,000 times the aggregate per share amount (payable in kind) of all non-cash dividends or other distributions, other than a dividend payable in shares of Common Stock or a subdivision of the outstanding shares of Common Stock (by reclassification or otherwise), declared on the Common Stock since the immediately preceding Quarterly Dividend Payment Date or, with respect to the first Quarterly Dividend Payment Date, since the first issuance of any share or fraction of a share of Junior Preferred Stock. In the event the Company shall at any time declare or pay any dividend on the Common Stock payable in shares of Common Stock, or effect a subdivision or combination or consolidation of the outstanding shares of Common Stock (by reclassification or otherwise than by payment of a dividend in shares of Common Stock) into a greater or lesser number of shares of Common Stock, then in each such case the amount to which holders of shares of Junior Preferred Stock were entitled immediately prior to such event under clause (b) of the preceding sentence shall be adjusted by multiplying such amount by a fraction, the numerator of which is the number of shares of Common Stock outstanding immediately after such event and the denominator of which is the number of shares of Common Stock that were outstanding immediately prior to such event.

(B) The Company shall declare a dividend or distribution on the Junior Preferred Stock as provided in paragraph (A) of this Section immediately after it declares a dividend or distribution on the Common Stock (other than a dividend payable in shares of Common Stock); provided , that in the event no dividend or distribution shall have been declared on the Common Stock during the period between any Quarterly Dividend Payment Date and the next subsequent Quarterly Dividend Payment Date, a dividend of $1.00 per share on the Junior Preferred Stock shall nevertheless be payable on such subsequent Quarterly Dividend Payment Date.

(C) Dividends shall begin to accrue and be cumulative on outstanding shares of Junior Preferred Stock from the Quarterly Dividend Payment Date next preceding the date of issue of such shares, unless the date of issue of such shares is prior to the record date for the first Quarterly Dividend Payment Date, in which case dividends on such shares shall begin to accrue from the date of issue of such shares, or unless the date of issue is a Quarterly Dividend Payment Date or is a date after the record date for the determination of holders of shares of Junior Preferred Stock entitled to receive a quarterly dividend and before such Quarterly Dividend Payment Date, in either of which events such dividends shall begin to accrue and be cumulative from such Quarterly Dividend Payment Date. Accrued but unpaid dividends shall not bear interest. Dividends paid on the shares of Junior Preferred Stock in an amount less than the total amount of such dividends at the time accrued and payable on such shares shall be allocated pro rata on a share-by-share basis among all such shares at the time outstanding. The Board of Directors may fix a record date for the determination of holders of shares of Junior Preferred Stock entitled to receive payment of a dividend or distribution declared thereon, which record date shall be not more than 60 days prior to the date fixed for the payment thereof.

Section 3. Voting Rights. The holders of shares of Junior Preferred Stock shall have the following voting rights:

(A) Subject to the provision for adjustment hereinafter set forth, each share of Junior Preferred Stock shall entitle the holder thereof to 1,000 votes on all matters submitted to a vote of the stockholders of the Company. In the event the Company shall at any time declare or pay any dividend on the Common Stock payable in shares of Common Stock, or effect a subdivision or combination or consolidation of the outstanding shares of Common Stock (by reclassification or otherwise than by payment of a dividend in shares of Common Stock) into a greater or lesser number of shares of Common Stock, then in each such case the number of votes per share to which holders of shares of Junior Preferred Stock were entitled immediately prior to such event shall be adjusted by multiplying such number by a

fraction, the numerator of which is the number of shares of Common Stock outstanding immediately after such event and the denominator of which is the number of shares of Common Stock that were outstanding immediately prior to such event.

(B) Except as otherwise provided herein, in any other Certificate of Designation creating a series of Preferred Stock or any similar stock, or by law, the holders of shares of Junior Preferred Stock and the holders of shares of Common Stock and any other capital stock of the Company having general voting rights shall vote together as one class on all matters submitted to a vote of stockholders of the Company.

(C) Except as set forth herein, or as otherwise provided by law, holders of Junior Preferred Stock shall have no special voting rights and their consent shall not be required (except to the extent they are entitled to vote with holders of Common Stock as set forth herein) for taking any corporate action.

Section 4. Certain Restrictions.

(A) Whenever quarterly dividends or other dividends or distributions payable on the Junior Preferred Stock as provided in Section 2 are in arrears, thereafter and until all accrued and unpaid dividends and distributions, whether or not declared, on shares of Junior Preferred Stock outstanding shall have been paid in full, the Company shall not:

(i) declare or pay dividends, or make any other distributions, on any shares of stock ranking junior (either as to dividends or upon liquidation, dissolution or winding up) to the Junior Preferred Stock;

(ii) declare or pay dividends, or make any other distributions, on any shares of stock ranking on a parity (either as to dividends or upon liquidation, dissolution or winding up) with the Junior Preferred Stock, except dividends paid ratably on the Junior Preferred Stock and all such parity stock on which dividends are payable or in arrears in proportion to the total amounts to which the holders of all such shares are then entitled;

(iii) redeem or purchase or otherwise acquire for consideration shares of any stock ranking junior (either as to dividends or upon liquidation, dissolution or winding up) to the Junior Preferred Stock, provided that the Company may at any time redeem, purchase or otherwise acquire shares of any such junior stock in exchange for shares of any stock of the Company ranking junior (either as to dividends or upon dissolution, liquidation or winding up) to the Junior Preferred Stock; or

(iv) redeem or purchase or otherwise acquire for consideration any shares of Junior Preferred Stock, or any shares of stock ranking on a parity (either as to dividends or upon liquidation, dissolution or winding up) with the Junior Preferred Stock, except in accordance with a purchase offer made in writing or by publication (as determined by the Board of Directors) to all holders of such shares upon such terms as the Board of Directors, after consideration of the respective annual dividend rates and other relative rights and preferences of the respective series and classes, shall determine in good faith will result in fair and equitable treatment among the respective series or classes.

(B) The Company shall not permit any subsidiary of the Company to purchase or otherwise acquire for consideration any shares of stock of the Company unless the Company could, under paragraph (A) of this Section 4, purchase or otherwise acquire such shares at such time and in such manner.

Section 5. Reacquired Shares. Any shares of Junior Preferred Stock purchased or otherwise acquired by the Company in any manner whatsoever shall be retired and cancelled promptly after the acquisition thereof. All such shares shall upon their cancellation become authorized but unissued shares of Preferred Stock and may be reissued as part of a new series of Preferred Stock subject to the conditions and restrictions on issuance set forth herein, in the Certificate of Incorporation, as amended, or in any other Certificate of Designation creating a series of Preferred Stock or any similar stock or as otherwise required by law.

Section 6. Liquidation, Dissolution or Winding Up. Upon any liquidation, dissolution or winding up of the Company, no distribution shall be made (1) to the holders of shares of stock ranking junior (either as to dividends or upon liquidation, dissolution or winding up) to the Junior Preferred Stock unless, prior thereto, the holders of shares of Junior Preferred Stock shall have received $250 per share, plus an amount equal to accrued and unpaid dividends and distributions thereon, whether or not declared, to the date of such payment, provided that the holders of shares of Junior Preferred Stock shall be entitled to receive an aggregate amount per share, subject to the provision for adjustment hereinafter set forth, equal to 1,000 times the aggregate amount to be distributed per share to holders of shares of Common Stock, or (2) to the holders of shares of stock ranking on a parity (either as to dividends or upon liquidation, dissolution or winding up) with the Junior Preferred Stock, except distributions made ratably on the Junior Preferred Stock and all such parity stock in proportion to the total amounts to which the holders of all such shares are entitled upon such liquidation, dissolution or winding up. In the event the Company shall at any time declare or pay any dividend on the Common Stock payable in shares of Common Stock, or effect a subdivision or combination or consolidation of the outstanding shares of Common Stock (by reclassification or otherwise than by payment of a dividend in shares of Common Stock) into a greater or lesser number of shares of Common Stock, then in each such case the aggregate amount to which holders of shares of Junior Preferred Stock were entitled immediately prior to such event under the proviso in clause (1) of the preceding sentence shall be adjusted by multiplying such amount by a fraction the numerator of which is the number of shares of Common Stock outstanding immediately after such event and the denominator of which is the number of shares of Common Stock that were outstanding immediately prior to such event.

Section 7. Consolidation, Merger, Etc. In case the Company shall enter into any consolidation, merger, combination or other transaction in which the shares of Common Stock are exchanged for or changed into other stock or securities, cash and/or any other property, then in any such case each share of Junior Preferred Stock shall at the same time be similarly exchanged or changed into an amount per share, subject to the provision for adjustment hereinafter set forth, equal to 1,000 times the aggregate amount of stock, securities, cash and/or any other property (payable in kind), as the case may be, into which or for which each share of Common Stock is changed or exchanged. In the event the Company shall at any time declare or pay any dividend on the Common Stock payable in shares of Common Stock, or effect a subdivision or combination or consolidation of the outstanding shares of Common Stock (by reclassification or otherwise than by payment of a dividend in shares of Common Stock) into a greater or lesser number of shares of Common Stock, then in each such case the amount set forth in the preceding sentence with respect to the exchange or change of shares of Junior Preferred Stock shall be adjusted by multiplying such amount by a fraction, the numerator of which is the number of shares of Common Stock outstanding immediately after such event and the denominator of which is the number of shares of Common Stock that were outstanding immediately prior to such event.

Section 8. No Redemption. The shares of Junior Preferred Stock shall not be redeemable.

Section 9. Rank. The Junior Preferred Stock shall rank, with respect to the payment of dividends and the distribution of assets, junior to all series of any other class of the Company’s Preferred Stock.

Section 10. Amendment. The Certificate of Incorporation of the Company, as amended, shall not be amended in any manner which would materially alter or change the powers, preferences or special rights of the Junior Preferred Stock so as to affect them adversely without the affirmative vote of the holders of at least two-thirds of the outstanding shares of Junior Preferred Stock, voting together as a single class.

EXHIBIT 10.1

EXECUTION COPY

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

BY AND BETWEEN

AMAG PHARMACEUTICALS, INC.

AND

TAKEDA PHARMACEUTICAL COMPANY LIMITED

MARCH 31, 2010

LICENSE, DEVELOPMENT AND COMMERCIALIZATION

AGREEMENT

This LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (the “Agreement” ) is entered into as of March 31, 2010 (the “Effective Date” ) by and between AMAG PHARMACEUTICALS, INC. , a Delaware corporation with its principal place of business at 100 Hayden Ave, Lexington, MA 02421, USA ( “AMAG” ), and TAKEDA PHARMACEUTICAL COMPANY LIMITED , a company incorporated under the laws of Japan, with its principal place of business at 1-1, Doshomachi 4-chome, Chuo-ku, Osaka, 540-8645, Japan ( “Takeda” ). AMAG and Takeda are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties ”.

RECITALS

WHEREAS , AMAG has launched in the United States and i s developing its proprietary Feraheme® (ferumoxytol) Injection product for the treatment and diagnosis of certain human diseases and conditions in and outside the United States ;

WHEREAS , Takeda possesses resources and expertise in the development, marketing, and commercialization of pharmaceutical products in the Licensed Territory (as defined below); and

WHEREAS , Takeda desires to collaborate with AMAG on the further development of the Product (as defined below) in the Field (as defined below) through regulatory approval in the Licensed Territory, and to obtain commercialization rights to the Product in the Field in the Licensed Territory, and AMAG is willing to so collaborate and to grant such rights on the terms and conditions hereof.

NOW, THEREFORE , in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in this Agreement, the Parties agree as follows:

ARTICLE 1

DEFINITIONS

1.1 “Acquiror” has the meaning set forth in Section 16.5.

1.2 “Affiliate” means, with respect to a particular Party or a Takeda sublicensee set forth in Section 2.1(c), a person, corporation, partnership, or other entity that controls, is controlled by or is under common control with such Party or sublicensee. 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 or cause the direction of the management and policies of such entity, whether by the ownership of fifty percent (50%) or more of the voting

stock of such entity, or by contract or otherwise. Notwithstanding the foregoing, Takeda Thailand Ltd. shall be deemed to be an Affiliate of Takeda.

1.3 [***] has the meaning set forth in Section 4.9(b)(ii).

1.4 “AMAG House Marks” means the AMAG names and logo as set forth on Exhibit D .

1.5 “AMAG Indemnitees” has the meaning set forth in Section 11.2.

1.6 “AMAG Know-How” means all Information that is Controlled by AMAG or its Affiliates as of the Effective Date or during the Term and is necessary or useful for the Development, Manufacture or Commercialization of the Product in the Field in accordance with the terms of this Agreement. For clarity, AMAG Know-How excludes Information claimed in any AMAG Patent. For avoidance of doubt, AMAG Know-How shall exclude the Information of any Third Party that becomes an Acquiror of AMAG, except for any Information included within the definition of “AMAG Know-How” that is developed by such Acquiror after the closing of such acquisition in the course of conducting activities on behalf of AMAG under this Agreement.

1.7 “AMAG Opt-In Study” has the meaning set forth in Section 4.6.

1.8 “AMAG Patent” means any Patent that (a) is Controlled by AMAG or its Affiliates as of the Effective Date or at any time during the Term, and (b) claims the composition of matter, use or Manufacture of the Product in the Field . A list of AMAG Patents in existence as of the Effective Date is attached hereto as Exhibit C-1 , and AMAG shall update such list from time to time to include additional AMAG Patents, including patents issuing from any listed application or claiming priority thereto or otherwise continuing therefrom. For the avoidance of doubt, AMAG Patents shall include Product Patents, and shall exclude the Takeda Patents and the Patents of any Third Party that becomes an Acquiror of AMAG, except for (i) any Patents claiming inventions that are included within the definition of an “AMAG Patent” that are developed by such Acquiror in the course of conducting activities on behalf of AMAG under this Agreement, or (ii) any Patents Controlled by such Acquiror at the closing of the acquisition of AMAG that claim the composition, use or manufacture of the Product as in existence as of the Effective Date.

1.9 “AMAG Product Marks” means all trademarks in the Licensed Territory related to the Product that are Controlled by AMAG or its Affiliates during the Term. The AMAG Product Marks i n existenc e (or for which AMAG or its Affiliates has submitted an application) a s of the Effective Date are set forth on Exhibit D , and shall be updated from time to time.

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

1.10 “AMAG Technology” means the AMAG Patents and AMAG Know-How.

1.11 “Asia-Pacific” means the countries shown in Part II of Exhibit B attached hereto, including any successor country and jurisdiction of any of such countries .

1.12 “Best Knowledge” means, as applied to a Party, that such Party shall be deemed to have knowledge of a particular fact or other matter to the extent that a reasonably prudent person with experience in the pharmaceutical industry and with primary responsibility for t he applicable subject matter would or should know of such fact or other matter upon diligent inquiry.

1.13 “CEE” means the countries shown in Part III of Exhibit B attached hereto , including any successor countr y or jurisdiction of any of such countries .

1.14 “CIS” means the countries shown in Part IV of Exhibit B attached hereto, including any successor countr y or jurisdiction of any of such countries .

1.15 “Claims” has the meaning set forth in Section 11.1.

1.16 “CMC” means chemistry, manuf acturing and contr ols as specified by the FDA.

1.17 “Commercialization,” with a correlative mean ing for “Commerci alize” and “Commercializing,” means all activities undertaken before and after obt aining Regulatory Approvals relating spe cifically to the pre-launch, launch, promotion, detailing, medical education and medical liaison activities, marketing, pricing, reimbursement, sale, distribution , and other commercialization related activities to be detailed in the Commercialization Plan of the Product, including but not limited to: (a) strategic marketing, sales force detailing, advertising, medical education and liaison, and market and Product support; (b) all customer support, Product distribution, invoicing and sales activities; and (c) Phase 4 Clinical Trials and other post-approval clinical studies other than those studies required by a Regulatory Authority or otherwise intended to be used to support the continued Regulatory Approval of a Product in a given indication in the Field in a country in the Licensed Territory .

1.18 “Commercialization Plan” has the meaning set forth in Section 6.2.

1.19 “Commercially Reasonable Efforts” means, with respect to the efforts to be expended, or considerations to be undertaken, by a Party and its Affiliates with respect to any objective, activity or decision to be undertaken hereunder, reasonable, good faith efforts to accomplish such objective, activity or decision as such Party would normally use to accomplish a similar objective, activity or decision under similar circumstances in connection with an active development , manufacturing or commercialization program, it being understood and agreed that with respect to the Development , Manufacture or Commercialization of the Product, such efforts shall be similar to those efforts and resources commonly used by such Party for a similar pharmaceutical product owned by it or to which it has similar rights (and not less than the efforts that would be applied by a similarly situated company using normal and customary level of efforts within the pharmaceutical industry for a comparable product), which product is at a

similar stage in its development or product life and is of similar market potential, taking into account efficacy, safety, approved labeling, the competitiveness of alternative products sold by Third Parties in the marketplace, the patent and other proprietary position of the Product, the likelihood of Regulatory Approval given the regulatory structure involved, and the profitability of the Product taking into consideration, among other factors, Third Party costs and expenses including the royalties, milestone and other payments payable to licensors of patent or other intellectual property rights, the Manufacturing cost of the Product , and the pricing and reimbursement relating to the Product. Commercially Reasonable Efforts shall be determined on a market-by-market and indication-by-indication basis for the Product, and it is anticipated that the level of effort may change over time, reflecting changes in the status of the Product and the market(s) involved.

1.20 “Committee” has the meaning set forth in Section 3.3(a).

1.21 “Confidential Information” means, with respect to a Party, all reports and other Information of such Party that are disclosed to the other Party under this Agreement, whether in oral, written, graphic, or electronic form. In addition, the terms of this Agreement shall be deemed the Confidential Information of both Parties. All Information disclosed by either Party pursuant to the Mutual Confidential ity Agreement between the Parties dated May 19, 2009 shall be deemed to be such Party’s Confidential Information disclosed hereunder.

1.22 “Control” means, with respect to any material, Information, or intellectual property right, that a Party (a) owns or (b) has a license to such material, Information, or intellectual property right and, in each case, has the ability to grant to the other Party access, a license, or a sublicense (as applicable) to the foregoing on the terms and conditions set forth in this Agreement without violating the terms of any then-existing agreement or other arrangement with any Third Party.

1.23 “ Designated Executive ” has the meaning set forth in Section 3.1(b).

1.24 “ Designated Second Source Supplier ” or “ DSS ” means a Third Party manufacturer of the Product designated in the Second Source Plan or designated by AMAG and reasonably acceptable to Takeda.

1.25 “Develop” or “Development” means all activities relating to preparing and conducting non-clinical studies, human clinical studies (other than the studies which are included in the definition of Commercialization) , regulatory activities ( e.g. , regulatory applications) and other development-related activities to be detailed in the Development Plan with respect to the Product, but excluding in each case any activities relating to the Manufacture of the Product.

1.26 “Development Plan” means that certain mutually agreed written development plan of all clinical studies to be performed for the Product for the Licensed Territory, titled “Feraheme Initial Clinical Development Plan,” dated March 31, 2010 and delivered to Takeda prior to the Effective Date, which Development Plan is incorporated herein by this reference, as amended in accordance with Section 4.3(b).

1.27 “Dollar” means a U.S. dollar, and “$” shall be interpreted accordingly.

1.28 “ EMA ” means the European Medicines Agency or any successor entity.

1.29 “Europe” means the countries shown in Part I of Exhibit B attached hereto, including any successor countr y or jurisdiction of any such countries .

1.30 “EU-5” means the countries of France, Germany, Italy, Spain, and United Kingdom.

1.31 “EU-15” means the countries of Austria, Belgium, Denmark, Finland, Ireland, Netherlands, Portugal, Norway, Sweden and Switzerland (i.e., Europe excluding the EU-5 and EU-30) .

1.32 “EU-30” means the countries of Bulgaria, Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Luxembourg, Malta, Poland, Romania, Slovakia, Slovenia, and Iceland (i.e., Europe excluding the EU-5 and EU-15) .

1.33 “FD&C Act” means the U.S. Federal Food, Drug and Cosmetic Act, as amended.

1.34 “FDA” means the U.S. Food and Drug Administration or any successor entity.

1.35 “Field” means the prevention, diagnosis and treatment of all human diseases and conditions , excluding the Imaging Field.

1.36 “Finish” means to label and package vials or other containers of the Product suitable for distribution to final users.

1.37 “First Commercial Sale” means the first sale to a Third Party of the Product in a given regulatory jurisdiction after Regulatory Approval has been obtained in such jurisdiction. For clarity, sales for test marketing, sampling and promotional or clinical trial purposes or compassionate or similar use shall not be considered to constitute a First Commercial Sale.

1.38 “Fiscal Year” means the twelve (12) consecutive month period beginning April 1 and ending March 31.

1.39 “ FTE ” means the equivalent of a full-time individual’s work time for a twelve (12)-month period of scientific, technical or managerial work under the Development Plan. The portion of an FTE year devoted by an individual to work under the Development Plan shall equal the average over twelve (12) consecutive months of the percent of maximum potential working time in a given month that such individual reported that he or she devoted to the Development Plan, which shall not be greater than one hundred percent (100%), according to Takeda’s then-current reporting practices.

1.40 “FTE Costs” means the internal costs incurred by Takeda, at the FTE Rate, for activities conducted under the Development Plan.

1.41 “FTE Rate” means the annual rate of [***] per FTE for Takeda’s personnel conducting activities under the Development Plan. Upon each anniversary of the Effective Date, the FTE Rate may be adjusted upon request of either Party in accordance with the change in the applicable government consumer price index for the most recent twelve-month period for which such information has been published in a relevant country(ies).

1.42 “Future Required Studies” has the meaning set forth in Section 4.4(c)(ii).

1.43 “ Generic Product” means, with respect to a particular Product, on a country-by-country basis, any pharmaceutical product that (i) contains substantially the same chemical composition, approximate chemical formula, and apparent molecular weight as the Product and has the same pharmaceutical form as the Product, (ii) obtains regulatory approval by reference to the Product pursuant to Article 10 (as applicable) of Directive 2001/83/EC and Article 3(3) of Regulation EC/726/2004 of the European Parliament and of the Council on the Community code relating to medicinal products for human use, as amended, or any similar approval in any country of the Licensed Territory that is based on reference to the Regulatory Approval for such Product in such country and a demonstration of therapeutic equivalence or similarity to such Product, and (iii) is sold in the same country as such Product by a Third Party that is not a sublicensee of Takeda or its Affiliates and did not purchase such product in a chain of distribution that included any of Takeda or its Affiliates or sublicensees.

1.44 “Good Clinical Practices” or “GCP” means the then-current standards, practices and procedures promulgated or endorsed by the FDA as set forth in the guidelines entitled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” including related regulatory requirements imposed by the FDA and comparable regulatory standards, practices and procedures promulgated by the EMA or other Regulatory Authority applicable to the Licensed Territory, as they may be updated from time to time, including applicable quality guidelines promulgated under the International Conference on Harmonization (“ ICH ”).

1.45 “Good Laboratory Practices” or “GLP” means the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and comparable regulatory standards promulgated by the EMA or other Regulatory Authority applicable to the Licensed Territory, as they may be updated from time to time, including applicable quality guidelines promulgated under the ICH.

1.46 “Good Manufacturing Practices,” “cGMP” or “GMP” means the then-current good manufacturing practices required by the FDA, as set forth in the FD&C Act and the regulations promulgated thereunder, for the manufacture and testing of pharmaceutical materials, and comparable laws or regulations applicable to the manufacture and testing of pharmaceutical materials promulgated by the EMA or other Regulatory Authority applicable to the Licensed

Territory , as they may be updated from time to time, including applicable quality guidelines promulgated under the ICH.

1.47 “Good Pharmacovigilance Practices” or “cGPvP” means the then-current good pharmacovigilance practices recommended by the FDA, EMA (including Volume 9A of The Rules Governing Medicinal Products in the European Union — Guidelines on Pharmacovigilance for Medicinal Products for Human Use), or other Regulatory Authority applicable to the Licensed Territory, as they may be updated from time to time, including applicable guidelines under the ICH.

1.48 “Governmental Authority” means any multi-national, federal, state, local, municipal, provincial or other government authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).

1.49 “Group” shall mean a group of Persons whose beneficial ownership of AMAG securities would be aggregated for purposes of Section 13(d) of the U.S. Securities and Exchange Act of 1934, as amended, and the rules promulgated thereunder.

1.50 “ IDA Indication ” is an indication for the treatment of iron deficiency anemia generally without limit to a specific patient population or sub-population.

1.51 “ Imaging Field ” means any use of the Product as an imaging agent (including use as a reagent) detected by magnetic resonance technology, including, for clarity, the use of such imaging agent for diagnostic purposes.

1.52 “Increase in Scope” has the meaning set forth in Section 4.9(b)(i).

1.53 “IND” means (a) an Investigational New Drug application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, or (b) the equivalent application to the equivalent Governmental Authority in any other regulatory jurisdiction outside the U.S., the filing of which is necessary to commence or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.

1.54 “Indemnified Party” has the meaning set forth in Section 11.3.

1.55 “Indemnifying Party” has the meaning set forth in Section 11.3.

1.56 “Indication” means any human disease or condition which can be treated, prevented or cured or the progression of which can be delayed and for which a Product is specifically developed in order to obtain Regulatory Approval.

1.57 “Information” means any data, results, technology, business or financial information or information of any type whatsoever, in any tangible or intangible form, including know-how, trade secrets, practices, techniques, methods, processes, inventions, developments, specifications, formulations, formulae, materials or compositions of matter of any type or kind (patentable or otherwise), software, algorithms, marketing reports, expertise, technology, test

data (including pharmacological, biological, chemical, biochemical, clinical test data and data resulting from non-clinical studies), CMC information, stability data and other study data and procedures.

1.58 “Initial Studies” has the meaning set forth in Section 4.4(a)(i).

1.59 “Insolvency Event” means, with respect to a Party, except for the event of a solvent reorganization or amalgamation, (a) the filing by such Party in court or agency pursuant to any applicable statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of such Party or of its assets, or (b) the filing by a Third Party against such Party of an involuntary petition in bankruptcy or seeking reorganization, liquidation, dissolution, winding up arrangement, composition or readjustment of such Party’s debts or any other relief under any bankruptcy, insolvency, reorganization or other similar act or law of any jurisdiction now or hereafter in effect, or the issuance of a warrant of attachment, execution or similar process against a Party, and, in each case, only if the applicable petition, warrant of attachment, execution or similar process is not dismissed within ninety (90) days after the filing thereof, or (c) that such Party proposes or is a party to any dissolution or liquidation under applicable law, or makes an assignment for the benefit of creditors, or (d) with respect to AMAG, issuance of a going concern opinion and a reasonable good faith determination by Takeda that the current financial condition of AMAG, as reflected in such opinion, is likely to have a material and adverse effect on AMAG’s ability to supply Product to Takeda in accordance with the terms of this Agreement and the Supply Agreement.

1.60 “Joint Development Committee” or “JDC” means the committee formed by the Parties as described in Section 3.2(a).

1.61 “Joint Steering Committee” or “JSC” means the committee formed by the Parties as described in Section 3.1(a).

1.62 “Laws” means all laws, statutes, rules, regulations, guidelines, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision, domestic or foreign.

1.63 “Licensed Territory” means Europe, CEE, CIS, Asia-Pacific and the countries shown in Part V of Exhibit B attached hereto, but excluding any country or territory in which this Agreement has been terminated under Article 13.

1.64 “Loss of Meaningful Exclusivity” means, with respect to a particular country and Product, the end of the [***] consecutive calendar month during which one or more T hird Parties sells a number of equivalent units of a Generic Product of such Product in such country

comprising, during each such month, at least [***] of the aggregate combined number of equivalent units of such Product and such Generic Product(s) sold in such month in such country. All such determinations of unit volume shall be based upon a mutually acceptable calculation method and using market share (calculated on unit number basis) data provided by a reputable and mutually agreed upon provider, such as IMS Health .

1.65 “ Manufacture ” with a correlative meaning for “ Manufacturing ,” means all activities related to the manufacturing of a pharmaceutical product, or any ingredient thereof, including manufacturing Product in finished form for Development, manufacturing finished Product for Commercialization, 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.

1.66 “Marketing Authorization Application” or “MAA” means an application to the appropriate Regulatory Authority for approval to market the Product (but excluding pricing approvals) in any particular jurisdiction.

1.67 “Net Sales” means the gross amounts invoiced by Takeda, its Affiliates and their respective sublicensees for sales of Product made to unaffiliated Third Parties, less the following deductions to the extent reasonable and customary provided to unaffiliated entities and actually allowed with respect to such sales:

(a) reasonable cash, trade or quantity discounts, charge-back payments, and rebates actually granted or administrative fees actually booked to trade customers, patients (including those in the form of a coupon or voucher), managed health care organizations, pharmaceutical benefit managers, group purchasing organizations and national, state, or local governments, and to the agencies, purchasers and reimbursers of managed health organizations, pharmaceutical benefit managers, group purchasing organizations, or federal, state or local governments; provided, however, that in each case such amounts shall be applied in a normal and customary manner with respect to other similarly situated products of the selling party and not applied disproportionately to the Product. The selling Party shall notify the other Party of any exceptional circumstances in order to adequately maintain the competitive position of the Product and the Parties shall confer in good faith regarding any deviation from such normal and customary practice;

(b) credits or allowances actually allowed upon prompt payment or on account of claims, damaged goods, rejections or returns of such Product, including in connection with recalls;

(c) freight, postage, shipping, transportation and insurance charges, in each case actually allowed or paid for delivery of Product, to the extent billed or recognized; and

(d) taxes (other than income taxes), duties, tariffs or other governmental charges levied on the sale of such Product, including value-added and sales taxes.

(e) Notwithstanding the foregoing, amounts received or invoiced by Takeda, its Affiliates, or their sublicensees for the sale of Product among Takeda, its Affiliates or their respective sublicensees for resale shall not be included in the computation of Net Sales hereunder. For purposes of determining Net Sales, the Product shall be deemed to be sold and booked when invoiced. Net Sales shall be accounted for in accordance with standard Takeda practices for operation by Takeda, its Affiliates or sublicensees, as practiced in the relevant country in the Licensed Territory, but in any event in accordance with respective local generally accepted accounting principles, consistently applied in such country in the Licensed Territory.

(f) Takeda, its Affiliates, and their respective sublicensees will not sell Product in combination with or as part of a bundle with other products or offer packaged arrangements to customers that include the Product in such a manner as to disproportionately discount the selling price of the Product, as compared with the weighted-average discount applied to the other products, as a percent of the respective list prices (or if not available, a good faith estimate thereof) of such products and the Product prior to applying the discount.

1.68 “New Product Marks” has the meaning set forth in Section 6.7(a).

1.69 “Non-Field Product” has the meaning set forth in Section 6.6(a).

1.70 “Off-label Use of Non-Field Product” has the meaning set forth in Section 6.6(a).

1.71 “Opt-In Study” has the meaning set forth in Section 4.9(c).

1.72 “Other AMAG Studies” has the meaning set forth in Section 4.5.

1.73 “Out-of-Pocket Costs” means any amounts paid by a Party to Third Parties in connection with activities or services conducted by such Third Parties, including clinical trial materials, contract research, laboratory services, consulting services, shipping and distribution. For clarity, Out-of-Pocket Costs for any Initial Studies, New Retreatment Study or New Pediatric Studies conducted by Takeda pursuant to Sections 4.4(a)(ii) and 4.4(b)(ii) and (iii), respectively, shall include Takeda’s payments to AMAG or to a Designated Second Source Supplier for Product used in such studies.

1.74 “Patent Challenge” has the meaning set forth in Section 13.4.

1.75 “Patent Term Extension” means any term extensions, supplementary protection certificates and equivalents thereof offering patent protection beyond the initial term with respect to any issued Patents.

1.76 “Patents” means (a) pending patent applications (and patents issuing therefrom), issued patents, utility models and designs; and (b) reissues, substitutions, confirmations, registrations, validations, re-examinations, additions, continuations, continued prosecution applications, continuations-in-part, or divisions of or to any patents, patent applications, utility models or designs, in each case being enforceable within the applicable territory.

1.77 “Pediatric Studies” has the meaning set forth in Section 4.4(b)(i).

1.78 “Person” shall mean a natural person, corporation, partnership, trust, joint venture, limited liability company, Regulatory Authority or any other entity or organization.

1.79 “Phase 3 Clinical Trial” means a clinical trial of a pharmaceutical product on patients, which trial(s) are designed to (a) establish that a drug is safe and efficacious for its intended use; (b) establish the dosage range to be prescribed; and (c) support approval of an application to a Regulatory Authority for the commercial marketing of such drug.

1.80 “Phase 4 Clinical Trial” means a clinical trial on patients, possibly including pharmacokinetic studies, which trial is (a) not required to obtain Regulatory Approval of the initial indication(s) for the Product, (b) not required by the Regulatory Authority as mandatory to be conducted on or after the Regulatory Approval of the initial indication(s), and (c) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product ( e.g. , providing additional drug profile, safety data or marketing support information, or supporting expansion of product labeling) (other than for Regulatory Approval). For clarity, Phase 4 Clinical Trials are the responsibility of Takeda as a Takeda Study and are not subject to the terms of Section 4.9(b).

1.81 “Product” means a pharmaceutical composition that (a) contains AMAG’s ferumoxytol described on Exhibit A or (b) is claimed by one of the following AMAG Patents: [***] or any patent issuing from [***], in any dosage form, formulation and form of administration.

1.82 “Product Complaint” means any written, verbal or electronic expression of dissatisfaction regarding the Product, including reports of actual or suspected product tampering, contamination, mislabeling or inclusion of improper ingredients.

1.83 “Product Infringement” has the meaning set forth in Section 9.5(b)(i).

1.84 “Product Inventions” has the meaning set forth in Section 9.1.

1.85 “Product Patent” has the meaning set forth in Section 9.1.

1.86 “Regulatory Approval” means all approvals necessary for the commercial sale of the Product for the Field, in a given country or regulatory jurisdiction, including a price and/or reimbursement permit, if required for commercial sale of the Product, and including approval of the MAA.

1.87 “Regulatory Authority” means, in a particular country or jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval in such country or jurisdiction.

1.88 “Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights (other than a patent right) conferred by any Governmental Authority with respect to the Product in a country in the Licensed Territory, including rights similar to those conferred in the U.S. under the Hatch-Waxman Act or the FDA Modernization Act of 1997.

1.89 “Regulatory Lead” has the meaning set forth in Section 5.2(a).

1.90 “Regulatory Materials” means regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Governmental Authority in order to Develop, Manufacture, market, sell or otherwise Commercialize the Product in a particular country, territory or possession. Regulatory Materials include INDs and MAAs.

1.91 “Royalty Term” means, with respect to a particular country in the Licensed Territory, the period of time beginning upon the date of First Commercial Sale of the Product for the Field in such country and continuing until the Loss of Meaningful Exclusivity for the Product in such country.

1.92 “SOPs” or “Standard Operating Procedures” has the meaning set forth in Section 7.4.

1.93 “Supply Agreement” has the meaning set forth in Section 7.2.

1.94 [***] has the meaning set forth in Section 4.9(b)(i).

1.95 “Takeda Indemnitees” has the meaning set forth in Section 11.1.

1.96 “Takeda Know-How” means all Information that (a) is Controlled by Takeda or its Affiliates as of the Effective Date and applied or used in connection with the Development, Manufacture or Commercialization by Takeda of the Product, or (b) arises from Takeda’s activities under this Agreement, but excluding any and all Product Inventions. For clarity, Takeda Know-How excludes Information claimed in any Takeda Patent. For the avoidance of doubt, Takeda Know-How shall exclude the Information of any Third Party that becomes an Acquiror of Takeda, except for any Information included within the definition of “Takeda Know-How” that is developed by such Acquiror after the closing of such acquisition in the course of conducting activities on behalf of Takeda under this Agreement.

1.97 “Takeda Marks” has the meaning set forth in Section 6.7(b).

1.98 “Takeda Opt-In Study” has the meaning set forth in Section 4.5.

1.99 “Takeda Patent” means any Patent that (a) is Controlled by Takeda or its Affiliates as of the Effective Date and applied or used in connection with the Development, Manufacture or Commercialization by Takeda of the Product hereunder, or (b) claims any inventions made by Takeda, other than the Product Inventions, in the course of conducting its activities under this Agreement. A list of the Takeda Patents in existence as of the Effective Date, if any, is as attached hereto as Exhibit C-2 , and Takeda shall update such list from time to time to include additional Takeda Patents, including patents issuing from any listed application or claiming priority thereto or otherwise continuing therefrom. For the avoidance of doubt, Takeda Patents shall exclude the Patents of any Third Party that becomes an Acquiror of Takeda, except for (i) any Patents claiming inventions that are included within the definition of a “Takeda Patent” that are developed by such Acquiror in the course of conducting activities on behalf of Takeda under this Agreement, or (ii) any Patents Controlled by such Acquiror at the closing of the acquisition of Takeda that claim the composition, use or manufacture of the Product as in existence as of the Effective Date.

1.100 “Takeda Studies” has the meaning set forth in Section 4.6.

1.101 “Takeda Technology” means the Takeda Patents and Takeda Know-How.

1.102 “Term” means the term of this Agreement, as determined in accordance with Article 13.

1.103 “Third Party” means any entity other than AMAG or Takeda or an Affiliate of either of them.

1.104 “Transfer Event” has the meaning set forth in Schedule 7.2.

1.105 [***] has the meaning set forth in Section 4.9(a)(ii).

1.106 “U.S. Studies” has the meaning set forth in Section 4.4(b).

1.107 “Withdrawal Notice” has the meaning set forth in Section 3.3(d).

ARTICLE 2

LICENSES AND EXCLUSIVITY

2.1 Licenses to Takeda under AMAG Technology

(a) Licenses to Takeda .

(i) Subject to the terms and conditions of this Agreement, AMAG hereby grants Takeda an exclusive (even as to AMAG except as provided in Section 2.1(b) below), royalty-bearing license, with the right to sublicense directly or through multiple tiers as provided in Section 2.1(c), under the AMAG Technology, to research, Develop, Finish, use, sell, offer for sale, distribute, import, export and otherwise Commercialize the Product in the Field in the Licensed Territory. In addition, for any Development or Commercialization activities permitted under Article 4, AMAG hereby grants Takeda a non-exclusive, royalty-bearing license, with the right to sublicense directly or through multiple tiers as provided in Section 2.1(c), under the AMAG Technology, to Develop, use, import and export the Product in the Field outside the Licensed Territory to conduct any such permitted activities solely to the extent for the Development or Commercialization of the Product in the Licensed Territory pursuant to the license granted in the immediately preceding sentence. Takeda’s right to use and access certain AMAG Know-How is subject to Takeda’s payment of certain Development expenses, as described in Section 4.11. For clarity, the foregoing licenses exclude the right to Manufacture or have Manufactured the Product, except for the right to Finish the Product, subject to the following subsection (ii).

(ii) Subject to the terms and conditions of this Agreement and the Supply Agreement, and effective only upon a Transfer Event and for so long thereafter as provided in the Supply Agreement, AMAG hereby grants Takeda a co-exclusive (with AMAG and the Designated Second Source Suppliers) license under the AMAG Technology to have Manufactured the Product by a Designated Second Source Supplier for Development and Commercialization of the Product by Takeda or its Affiliates or sublicensees pursuant to the license granted in Section 2.1(a)(i).

(b) AMAG Retained Rights . Notwithstanding the rights granted to Takeda in Section 2.1(a) and without limiting the generality of Section 2.5, AMAG retains the following: (i) subject to Section 4.5, the right to conduct or have conducted clinical trials and other studies in the Licensed Territory for the generation of data in support of any regulatory submissions to (x) any Regulatory Authority outside the Licensed Territory or (y) the Regulatory Authorities within the Licensed Territory only to the extent as provided in Article 4; and (ii) the right to Manufacture or have Manufactured Product anywhere in the Licensed Territory, in each case together with the right to import and export the Product in such territories for such purposes.

(c) Sublicense Rights . Takeda shall have the right, directly or through multiples tiers, to (i) grant sublicenses of the licenses granted in Section 2.1(a)(i) to one or more of its Affiliates at any time; (ii) upon written notice to the JSC, grant sublicenses of the license granted under Section 2.1(a)(i) to one or more Third Parties; provided, however, that the right to sublicense the right to Develop the Product under this Section 2.1(c)(ii) may be granted only to a sublicensee of the right to Commercialize the Product, and such Development shall be limited to clinical studies required to obtain or maintain Regulatory Approval in a particular country, subject to Section 4.4(c); and (iii) grant sublicenses under its Development rights under Section 2.1(a)(i) (A) in the EU-5 to Third Parties upon the written consent of AMAG, at AMAG’s sole discretion, and (B) in the Licensed Territory outside the EU-5 to Third Parties upon the written

consent of AMAG, not to be unreasonably withheld. Takeda shall provide all information reasonably requested by the JSC prior to entering into any such Third Party arrangement and shall, within thirty (30) days after granting a Third Party a sublicense under the licenses granted in Section 2.1(a)(i), notify AMAG of the grant of such sublicense and provide AMAG with a true and complete copy of the sublicense agreement (provided that Takeda may redact any information contained therein that is not necessary to disclose to ensure compliance with this Agreement). Each sublicense agreement shall be consistent with the terms and conditions of this Agreement. Takeda shall, in each agreement under which it grants a sublicense under the license set forth in Section 2.1(a)(i) (each, a “Takeda Sublicense Agreement” ), require the sublicensee (A) to provide Information to Takeda to the extent necessary for Takeda and AMAG to comply with their obligations under Article 5, and (B) to provide the following to AMAG, if this Agreement terminates, or to Takeda, if only such Takeda Sublicense Agreement terminates: (x) the assignment and transfer of ownership and possession of all Regulatory Materials (including Regulatory Approvals) held or possessed by such sublicensee (which assignment could also be directly to Takeda prior to any such termination), and (y) the assignment of all intellectual property Controlled by such sublicensee that covers a Product or its respective use, manufacture, sale, or importation and was created by or on behalf of such sublicensee during the exercise of its rights or fulfillment of its obligations pursuant to such Takeda Sublicense Agreement. In addition, Takeda will include provisions in each Takeda Sublicense Agreement providing that if the sublicensee or any of its Affiliates undertakes a Patent Challenge, Takeda may terminate all sublicenses under the AMAG Patents granted to such sublicensee. If a sublicensee (or an Affiliate of such sublicensee) undertakes a Patent Challenge, then Takeda, upon receipt of notice thereof from AMAG, will terminate all sublicenses under the AMAG Patents granted to such sublicensee in the applicable sublicense agreement. Takeda shall be responsible for ensuring that its sublicensees comply with the terms of this Agreement, and the operations of all such sublicensees with respect to Takeda’s rights or obligations hereunder shall be deemed to be the operations of Takeda, for which Takeda shall be responsible.

2.2 License to AMAG . Subject to the terms and conditions of this Agreement, Takeda hereby grants to AMAG (a) a non-exclusive, royalty-free license (with the right to sublicense as provided below) in the Field under the Takeda Technology to Develop, use, make, and have made the Product in the Licensed Territory pursuant to the terms of this Agreement and the Supply Agreement, and (b) a non-exclusive, royalty-free, perpetual, irrevocable license, with the right to grant sublicenses through multiple tiers, under the Takeda Technology to develop, make, have made, use, sell, offer for sale and import the Product in the Field outside the Licensed Territory; provided, however, that upon any material breach of this Agreement by AMAG, and notwithstanding AMAG’s timely cure of such breach, the foregoing license under this subsection 2.2(b) shall become a royalty-bearing license, which shall start to accrue on the date of such material breach, subject to a commercially reasonable royalty rate to be negotiated in good faith by the Parties and, if not agreed by the Parties within sixty (60) days after commencing negotiations, determined by the panel of neutrals pursuant to Section 14.4. In addition, upon AMAG’s written request, Takeda shall, in good faith, negotiate with AMAG the terms and conditions under which Takeda would grant to AMAG (c) a non-exclusive, royalty-bearing, worldwide license, with the right to grant sublicenses through multiple tiers, under the Takeda Technology to research, develop, make, have made, use, sell, offer for sale and import

the Product outside the Field. AMAG’s right to use and access certain Takeda Know-How is subject to AMAG’s payment of certain Development expenses, as described in Section 4.11. If AMAG desires to sublicense the rights granted by Takeda under subsection (b) or (c) above, AMAG shall notify Takeda in advance and provide any information reasonably requested by Takeda with respect to such proposed sublicensee. AMAG shall be responsible for ensuring that its sublicensees comply with the terms of this Agreement, and the operations of all such sublicensees with respect to AMAG’s rights or obligations hereunder shall be deemed to be the operations of AMAG, for which AMAG shall be responsible.

2.3 Negative Covenant . Each Party covenants that it will not use or practice any of the other Party’s intellectual property rights licensed to it under this Article 2 except for the purposes expressly permitted in the applicable license grant.

2.4 Right of First Negotiation. AMAG shall not commercialize the Product in the Imaging Field in the Licensed Territory, whether by itself or through its Affiliates or a Third Party, without first offering such commercialization right to Takeda as set forth in this Section 2.4. [***]

2.5 No Implied Licenses . Except as explicitly set forth in this Agreement, neither Party grants any license, express or implied, under its intellectual property rights to the other Party.

2.6 Exclusivity.

(a) Takeda hereby covenants that, [***] in any country or countries terminated under this Agreement, neither it nor its Affiliates will, directly or indirectly, by itself or with a Third Party, commercialize any pharmaceutical product in the Licensed Territory and in the Field: (i) containing or comprising iron as the primary active pharmaceutical ingredient formulated for delivery by parenteral means and (ii) indicated for the treatment of anemia, including iron deficiency anemia (except for any Product under this Agreement during the Term). Notwithstanding the foregoing, if [***], Takeda acquires a Third Party that is commercializing a product in the Field in the Licensed Territory that would constitute a breach of the immediately preceding sentence, Takeda shall divest or otherwise cease to commercialize such product in the Field in the Licensed Territory [***].

(b) AMAG hereby covenants that during the Term, neither it nor its Affiliates will, directly or indirectly, by itself or with a Third Party, commercialize in the Licensed Territory and in the Field any pharmaceutical product containing or comprising iron as the primary active pharmaceutical ingredient formulated for delivery by parenteral means. Notwithstanding the foregoing, if during the Term, AMAG acquires a Third Party (and such acquisition does not result in a Change of Control of AMAG) that is commercializing a product

in the Field in the Licensed Territory that would constitute a breach of the immediately preceding sentence, AMAG shall divest or otherwise cease to commercialize such product in the Field in the Licensed Territory [***].

(c) Notwithstanding Section 2.6(b), if an Acquiror of AMAG is conducting human clinical trials for or commercializing, at the closing of the acquisition of AMAG, a product that would constitute a breach of Section 2.6(b), the Acquiror may elect one of the following by written notice to Takeda [***]: (1) to divest or otherwise cease to clinically develop or commercialize such product in the Field in the Licensed Territory [***], in which case such product will not be deemed a breach of Section 2.6(b), or (2) to continue the clinical development or commercialization of such product, in which case this Section 2.6 would immediately be of no further force and effect. In addition, notwithstanding Section 2.6(b), an Acquiror of AMAG shall have the right to conduct research and preclinical development in the Field of a pharmaceutical product containing or comprising iron as the primary active pharmaceutical ingredient formulated for delivery by parenteral means, provided that such product does not use any AMAG Know-How and is not claimed by any AMAG Patent. Commencing upon the Acquiror’s initiating human clinical trials for such product, this Section 2.6 would be of no further force and effect.

2.7 Cross-Territorial Restrictions.

(a) Takeda hereby covenants and agrees that it shall not, and will ensure that its Affiliates and sublicensees will not, either directly or indirectly, actively promote, market, distribute, import, sell or have sold Product into countries outside the Licensed Territory. As to such countries outside the Licensed Territory: (i) Takeda shall not, and will ensure that its Affiliates and sublicensees will not, engage in any advertising or promotional activities relating to the Product directed primarily to customers or other buyers or users of the Product located in such countries; and (ii) Takeda shall not, and will ensure that its Affiliates and sublicensees will not, solicit orders from any prospective purchaser located in such countries. If Takeda receives any order from a prospective purchaser located in a country outside the Licensed Territory from which re-imports into the Licensed Territory are unlikely, Takeda shall immediately refer that order to AMAG. Takeda shall not accept any such orders. Takeda may not deliver or tender (or cause to be delivered or tendered) any Product into a country outside of the Licensed Territory from which re-imports into the Licensed Territory are unlikely. Takeda shall not, and will ensure that its Affiliates and sublicensees will not, restrict or impede in any manner AMAG’s exercise of its retained rights outside the Licensed Territory, provided that any such exercise of rights by AMAG shall comply with the terms of this Agreement.

(b) Unless otherwise permitted herein, AMAG hereby covenants and agrees that it shall not, and will ensure that its Affiliates or its sublicensees will not, either directly or indirectly, promote, market, distribute, import, sell or have sold Product in the Field into any

countries in the Licensed Territory. As to such countries in the Licensed Territory, (i) AMAG shall not, and will ensure that its Affiliates and sublicensees will not, engage in any advertising or promotional activities relating to the Product in the Field directed primarily to customers or other buyers or users of the Product located in such countries; and (ii) AMAG shall not, and will ensure that its Affiliates and sublicensees will not, solicit orders from any prospective purchaser located in such countries. If AMAG receives any order from a prospective purchaser located in a country in the Licensed Territory from which re-imports to a country outside the Licensed Territory are unlikely, AMAG shall immediately refer that order to Takeda. AMAG shall not accept any such orders. AMAG may not deliver or tender (or cause to be delivered or tendered) any Product in the Field into a country in the Licensed Territory from which re-imports into a country outside the Licensed Territory are unlikely. AMAG shall not, and will ensure that its Affiliates and sublicensees will not, restrict or impede in any manner Takeda’s exercise of its rights granted under this Agreement in the Licensed Territory, provided that any such exercise of rights by Takeda shall comply with the terms of this Agreement.

ARTICLE 3

MANAGEMENT

3.1 Joint Steering Committee .

(a) Formation and Role . The Parties agree to establish a Joint Steering Committee (or “ JSC ”) for the overall coordination and oversight of the Parties’ activities under this Agreement, promptly after the Effective Date. The JSC shall operate by the procedures set forth in Section 3.3. Subject to Section 14.2(b), the role of the Joint Steering Committee shall be:

(i) to review and discuss the overall strategy for the Development, Manufacture, and Commercialization of the Product for the Licensed Territory in the Field;

(ii) to review, discuss and approve the Development Plan (and any proposed amendments or revisions to such plan) and the overall strategy for Regulatory Approval (including the initial approval and any supplements and expansions thereof);

(iii) to review and discuss the Commercialization Plan (and any proposed amendments or revisions to such plan); and

(iv) to establish such subcommittees and to perform such other functions as appropriate to further the purposes of this Agreement, as determined by the Parties in writing.

(b) JSC Decisions and Actions . Actions to be taken by the Joint Steering Committee shall be taken only following unanimous vote, with each Party having one (1) vote. If the Joint Steering Committee fails to reach unanimous agreement on a matter before it for decision for a period in excess of ten (10) business days, either Party may submit the matter to a senior executive officer designated in writing by each Party having sufficient decision making

authority over the particular matter and not serving on any Committee (a “ Designated Executive ”) for resolution in accordance with the decision-making procedures described in Section 14.2, including the specific decision-making rights of each Party as described in such section.

3.2 Joint Development Committee

(a) Formation and Role . The Parties agree to establish a Joint Development Committee (or “ JDC ”), which will monitor and coordinate communication and operations regarding the Parties’ efforts with respect to the Development and Regulatory Approval of the Product in the Field in the Licensed Territory, including creation, amendment and oversight of the Development Plan and operational Development activities. Each Party shall have an equal number of representatives on the Joint Development Committee. The JDC shall operate by the procedures set forth in Section 3.3. The role of the JDC shall be:

(i) to facilitate the exchange of Information between the Parties under this Agreement with respect to their Product-related activities, including as and to the extent necessary for each Party to perform its obligations under this Agreement;

(ii) to review and discuss the Development Plan and all amendments and updates thereto; and

(iii) to establish such working teams or subcommittees and to perform such other functions as appropriate to further the purposes of this Agreement, as determined by the Parties in writing.

(b) JDC Decisions and Actions . Actions to be taken by the JDC shall be taken only following unanimous vote, with each Party having one (1) vote. If the JDC fails to reach unanimous agreement on a matter before it for decision for a period in excess of ten (10) business days from the date first presented to the JDC in writing, the matter shall be referred immediately to the JSC.

(c) Protocols Review . If (i) Takeda desires to conduct a Takeda Study as permitted under Article 4, or any Development activity assumed by Takeda under Section 4.4, or (ii) AMAG desires to conduct an Other AMAG Study as permitted under Article 4, or Phase 4 Clinical Trials in the Licensed Territory for the purpose of obtaining Regulatory Approval for or Commercializing the Product outside the Licensed Territory, then in each case (i) and (ii) such Party shall notify the JDC at the first JDC meeting following such Party’s decision to conduct any such activities. With respect to any proposed clinical trial, the proposing Party shall provide to the JDC, as soon as available (if not available prior to such meeting), the protocol, primary and secondary endpoints, inclusion and exclusion criteria, comparators, estimated number of patients, and statistical power for such trial, and the countries in which such trial will be conducted, as well and any other material matters pertaining to such study.

(d) AMAG Budgets . For each clinical trial that AMAG conducts under this Agreement and that Takeda has the right to assume under Section 4.4(a)(ii), 4.4(b)(ii), 4.4(b)(iii)

or 4.4(c)(iii), AMAG shall provide the JDC with a reasonably detailed budget of the Out-of-Pocket Costs for such clinical trial at the first JDC meeting after the Effective Date, and shall provide updates thereafter on an annual basis or upon material changes to the budget by AMAG. AMAG shall respond to Takeda’s reasonable requests for detailed information supporting any such budget.

3.3 Committee Membership and Procedures.

(a) Membership. AMAG and Takeda shall each designate an equal number of representatives (each of whom shall be in a management position of the applicable Party) to serve on the JSC and JDC (each a “Committee” ) by written notices to the other Party. Representatives selected for the JDC shall have appropriate expertise/experience in clinical development of pharmaceutical products. Initially, each Party shall designate three (3) representatives for each Committee. Each Committee may elect to vary the number of representatives from time to time during the Term. Either Party may designate substitutes for its representatives if one (1) or more of such Party’s designated representatives is unable to be present at a meeting. From time to time each Party may replace its representatives by written notice to the other Party specifying the prior representative(s) and their replacement(s). Each Committee will have a chairperson, to be designated as described below. The chairperson shall be responsible for (i) calling meetings, (ii) preparing and issuing minutes of each such meeting within ten (10) business days thereafter, and (iii) preparing and circulating an agenda for the upcoming meeting, but shall have no special authority over the other members of the Committee, and shall have no additional voting rights or powers beyond those held by the other members of the Committee.

(b) Chairperson

(i) The initial chairperson of the JSC shall be appointed by Takeda. On each anniversary of the Effective Date, the Parties shall alternate designation of the chairperson of the JSC for the commencing year.

(ii) The initial chairperson of the JDC shall be appointed by AMAG. On each anniversary of the Effective Date, the Parties shall alternate designation of the chairperson of the JDC for the commencing year.

(c) Meetings. Meetings of a Committee shall be held at least quarterly during the first eighteen (18) months after the Effective Date and twice per year thereafter during the Term, unless the Parties mutually agree in writing to a different frequency for such meetings. No later than ten (10) business days prior to any regularly scheduled meeting of a Committee, the chairperson shall prepare and circulate an agenda for such meeting and, as soon as practicable, materials for the meeting; provided, however, that either Party may propose additional topics to be included on such agenda, prior to such meeting. A Committee may meet in person, by videoconference or by teleconference, provided that at least one meeting during each calendar year is in person. With the prior consent of the other Party’s representatives (such consent not to be unreasonably withheld or delayed), each Party may invite non-members to participate in the discussions and meetings of a Committee, provided that such participants shall have no voting

rights or powers and shall be subject to the confidentiality provisions set forth in Article 12. Each Party will bear the expense of its respective members’ participation in Committee meetings. Meetings of a Committee shall be effective only if at least two (2) representatives of each Party are present or participating in such meeting. The chairperson of a Committee will be responsible for preparing reasonably detailed written minutes of all Committee meetings that include material decisions made at such meetings. The chairperson shall send draft meeting minutes to each member of the Committee for review and approval within ten (10) business days after each Committee meeting. Such minutes will be deemed approved unless one or more members of the Committee objects to the accuracy of such minutes within ten (10) business days of receipt.

(d) Discontinuation of Participation in a Committee . At any time during the Term and for any reason, either Party shall have the right to withdraw from participation in a Committee upon written notice to the other Party, which notice shall be effective immediately upon receipt (“ Withdrawal Notice ”). Following the issuance of a Withdrawal Notice and subject to this Section 3.3(d), the applicable Committee shall be disbanded and all decisions expressly delegated to such Committee shall be made by a representative of the Parties subject to the escalation procedures in Section 14.2. If, at any time following the issuance of a Withdrawal Notice, such Party wishes to resume participating in the Committee, such Party shall notify the other Party in writing, and after thirty (30) days from the date of such notice, the Committee shall be reinstated and the terms of this Article 3 shall apply to such Committee from and after such date. For clarity, the withdrawal by a Party under this Section 3.2(d) shall only limit such Party’s rights and obligations under this Article 3 with respect to participation and decision-making in the Committee. Notwithstanding the foregoing, a Party may not withdraw from or rejoin a Committee more than once during any Fiscal Year.

(e) Authority . The JSC and JDC shall each perform its responsibilities and make decisions under this Agreement based on the principles of prompt and diligent Development and Commercialization of Product in the Licensed Territory with Commercially Reasonable Efforts, consistent with good pharmaceutical practices and commercially reasonable consideration of the optimal balance of maximizing long-term profits derived from the sale of the Product in the Licensed Territory in the context of the estimated costs for Development and Commercialization of the Product in the Licensed Territory. The JSC and the JDC shall each have only the powers assigned expressly to it in this Article 3 and elsewhere in this Agreement, and shall not have any power to amend, modify or waive compliance with this Agreement. The JSC and JDC shall be responsible for setting overall strategic direction relating to and the Development Plan and Commercialization Plan as set forth in this Article 3, but day-to-day, tactical or operational matters with respect to the Development and Commercialization of the Product in the Licensed Territory will be decided, in accordance with the terms of this Agreement, by the Party responsible hereunder for the execution of such matters.

3.4 Alliance Managers . Promptly following the Effective Date, each Party shall designate in writing an individual as its alliance manager to facilitate communication and coordination of the Parties’ activities under this Agreement relating to the Product.

3.5 Collaboration Guidelines . Subject to the terms of this Agreement, the activities and resources of each Party shall be managed by such Party, acting independently and in its individual capacity.

ARTICLE 4

PRODUCT DEVELOPMENT

4.1 Overview of Product Development . The Parties desire and intend to collaborate with respect to the Development of the Product in the Licensed Territory in the Field, as and to the extent set forth in this Agreement. In general, AMAG shall be responsible for conducting the Development activities for the Product for the Licensed Territory contemplated as of the Effective Date and any additional studies required by a Regulatory Authority in the Licensed Territory for Regulatory Approval, unless otherwise agreed by the Parties.

4.2 Principles of Product Development . Each Party’s Development of the Product in the Field for the Licensed Territory shall be conducted in a manner consistent with the following principles: (1) seeking Regulatory Approval that includes the appropriate label for such Product in light of the clinical data, and (2) obtaining Regulatory Approval for such Product consistent with the preceding clause and in a timely manner in accordance with the terms of this Agreement.

4.3 Development Plan .

(a) Initial Development Plan . All Development of the Product in the Field for the Licensed Territory shall be conducted pursuant to the Development Plan. The Development Plan shall specify (i) the plans and timeline for preparing the necessary Regulatory Materials and for obtaining Regulatory Approval for the Product in the Licensed Territory, (ii) the Development activities of each Party and (iii) clinical supply for the Product. Each Party shall conduct its Development activities in accordance with the then-current Development Plan and the terms of this Agreement.

(b) Amendments . From time to time and, on at least an annual basis, the JDC shall update and amend, as appropriate, the then-current Development Plan, including to address any changes to the Initial Studies that the JSC deems necessary to ensure the commercial viability of the Product. If either Party desires to materially change a study then set forth in the Development Plan or to conduct a study or other activity not then set forth in the Development Plan, such Party shall notify the JDC, and the JDC shall discuss such proposed changes and corresponding amendment to the Development Plan. In addition, if a Regulatory Authority in the Licensed Territory communicates to a Party that additional studies or material changes to then-contemplated studies may be required as a condition of approval of the MAA by such Regulatory Authority, or for appropriate reimbursement for the Product, the Parties shall immediately notify the JDC, and the JDC shall promptly meet to discuss a response to such Regulatory Authority decision. Within ninety (90) days after such meeting, the Parties shall prepare an amendment to the Development Plan to reflect the JDC’s discussion and decision, subject to Section 4.9. The JDC shall submit each amendment to the JSC for review and

approval. If the JSC fails to agree on any amendment to the Development Plan, the matter shall be submitted to the Designated Executives pursuant to Section 3.1(b) for resolution in accordance with Section 14.2. For clarity, notwithstanding anything to the contrary in this Agreement, each Party shall have the right to suspend, terminate or modify any Development activities conducted by such Party as reasonably necessary to ensure the health, safety or welfare of a subject in any clinical trial.

4.4 AMAG Development Responsibilities.

(a) Initial Studies.

(i) AMAG shall be responsible for conducting, at its sole cost and expense, subject to Sections 4.9(a)(ii), 4.9(a)(iii) and 4.9(b), the Development activities reasonably necessary to perform the studies set forth on Schedule 4.4(a) (the “ Initial Studies ”), as described in the Development Plan. AMAG shall have the right to use any and all data and results generated from the Initial Studies for any and all purposes outside the Licensed Territory. For the avoidance of doubt, Takeda shall have the right to use data and all other Information from the Initial Studies included in the AMAG Technology for the purposes of obtaining and maintaining Regulatory Approval for the Product in the Field in the Licensed Territory in accordance with the terms of this Agreement. AMAG shall in all material respects timely conduct all Development activities for the Initial Studies as set forth in the then-current Development Plan.

(ii) In the event that AMAG materially fails to perform the Initial Studies consistent with the then-current Development Plan (such failure referred to herein as an “ Initial Studies Failure ”), Takeda shall have the right to allege an Initial Studies Failure by written notice to AMAG, such notice to set forth the basis for such alleged failure in reasonable detail. AMAG shall have a period of [***] to cure such failure to Takeda’s reasonable satisfaction. If AMAG does not so cure such failure, then Takeda shall have the right to conduct the Initial Studies to which the material failure pertains in accordance with the then-current Development Plan as reasonably amended by Takeda, consistent with its obligation to use Commercially Reasonable Efforts under Section 4.7, to mitigate the consequences of such failure. Takeda shall provide such amended Development Plan to the JDC promptly after preparation thereof. Upon Takeda’s exercise of such right, AMAG shall provide Takeda with its then-current budget for the Out-of-Pockets Costs for the applicable study and any supporting material reasonably requested by Takeda to the extent necessary or useful for Takeda to conduct such studies. If Takeda conducts such studies, AMAG shall, at its expense, take all actions reasonably required to transfer such studies to Takeda in a timely, efficient and effective manner, including procurement of manufacture and supply of the necessary Product for the studies and/or the management of the studies, which AMAG shall facilitate by introducing Takeda to AMAG’s Third Party vendors, including CROs, and, upon Takeda’s request, using reasonable efforts to

assign to Takeda or amend as appropriate any Third Party contracts to the extent related to such studies, [***]. Upon the [***] of an Initial Studies Failure, Takeda shall have the right to assume responsibility for and conduct the Initial Studies to which such failure pertains as provided above in this Section 4.4(a)(ii), notwithstanding AMAG’s timely cure of such Initial Studies Failure.

(b) U.S. Studies and Pediatric Studies.

(i) AMAG shall use Commercially Reasonable Efforts to conduct, at its sole cost and expense, subject to Sections 4.9(a)(ii), 4.9(a)(iii) and 4.9(b), (x) a placebo-controlled Phase 3 Clinical Trial of the Product for iron deficiency anemia and a long-term retreatment study, for the purpose of generating data to submit to the FDA to support Regulatory Approval of the Product in the U.S. (the “ U.S. Studies ”) and (y) four (4) pediatric Phase 4 Clinical Trials set forth in the pediatric investigation plan approved by the Pediatric Committee of the EMA (the “ Pediatric Studies ”). A list of the U.S. Studies and Pediatric Studies is set forth on Schedule 4.4(b) . For the avoidance of doubt, Takeda shall have the right to use data and all other Information from the U.S. Studies and the Pediatric Studies included in the AMAG Technology for the purposes of obtaining and maintaining Regulatory Approval for the Product in the Licensed Territory in accordance with the terms of this Agreement. AMAG shall use Commercially Reasonable Efforts to timely conduct all Development activities for the U.S. Studies and Pediatric Studies as set forth in the then-current Development Plan.

(ii) In the event that (x) AMAG does not complete the long-term retreatment study for iron deficiency anemia included in the U.S. Studies ( “U.S. Retreatment Study” ) as described in the Development Plan as of the Effective Date, [***] as set forth in the Development Plan as of the Effective Date, or (y) AMAG discontinues the U.S. Retreatment Study prior to its planned completion date, upon the occurrence of which AMAG shall immediately notify Takeda, then AMAG shall, at its expense, conduct an additional study ( “New Retreatment Study” ) to generate equivalent data in all material respects for Takeda to submit to the EMA. In such event, AMAG shall initiate (i.e., first dosing of the first patient) the New Retreatment Study [***], and shall use Commercially Reasonable Efforts to complete the New Retreatment Study on a timely basis. Notwithstanding the foregoing, Takeda shall have the right to conduct the New Retreatment Study upon written notice to AMAG [***], in accordance with the then-current Development Plan as reasonably amended by the JDC and approved by the JSC to mitigate the consequences of such failure, if AMAG has not then initiated such study. Upon Takeda’s exercise of such right, AMAG shall provide Takeda with its then-current budget for the Out-of-Pockets Costs for the applicable study and any supporting material reasonably requested by Takeda to the extent necessary or useful for Takeda to conduct such studies. If Takeda conducts such study, AMAG shall be relieved of its obligation to conduct such study and shall, at its expense, take all actions reasonably required to transfer the study to Takeda in a timely,

efficient and effective manner, including procurement of manufacture and supply of the necessary Product for such study and/or the management of such study, which AMAG shall facilitate by introducing Takeda to AMAG’s Third Party vendors, including CROs, and, upon Takeda’s request, using reasonable efforts to assign or amend as appropriate any Third Party contracts to the extent related to such study, and [***].

(iii) In the event that (x) AMAG does not complete the Pediatric Studies as described in the Development Plan as of the Effective Date, [***], or (y) AMAG discontinues the Pediatric Studies prior to their planned completion date, upon the occurrence of which AMAG shall immediately notify Takeda, then AMAG shall, at its expense, conduct additional studies ( “New Pediatric Studies” ) to generate equivalent data in all material respects for Takeda to submit to the EMA. In such event, AMAG shall initiate (i.e., first dosing of the first patient) the New Pediatric Studies [***], and shall use Commercially Reasonable Efforts to complete the New Pediatric Studies on a timely basis. Notwithstanding the foregoing, Takeda shall have the right to conduct the New Pediatric Studies upon written notice to AMAG [***], in accordance with the then-current Development Plan as reasonably amended by the JDC and approved by the JSC to mitigate the consequences of such failure, if AMAG has not then initiated such study. Upon Takeda’s exercise of such right, AMAG shall provide Takeda with its then-current budget for the Out-of-Pockets Costs for the applicable study and any supporting material reasonably requested by Takeda to the extent necessary or useful for Takeda to conduct such studies. If Takeda conducts such studies, AMAG shall be relieved of its obligation to conduct such studies and shall, at its expense, take all actions reasonably required to transfer such studies to Takeda in a timely, efficient and effective manner, including procurement of manufacture and supply of the necessary Product for such studies and/or the management of such studies, which AMAG shall facilitate by introducing Takeda to AMAG’s Third Party vendors, including CROs, and, upon Takeda’s request, using reasonable efforts to assign or amend as appropriate any Third Party contracts to the extent related to the clinical trials, and [***].

(iv) For clarity, if AMAG conducts the U.S. Retreatment Study and Pediatric Studies in accordance with the Development Plan, and the EMA or other Regulatory Authority in the Licensed Territory determines that such study is insufficient for approval of the MAA and an additional study is required, then such additional required study shall be a Future Required Study subject to Section 4.4(c) below and shall not be a New Retreatment Study or New Pediatric Study (as the case may be) subject to this Section 4.4(b).

(c) Future Required Studies .

(i) In addition to the Initial Studies, U.S. Studies and Pediatric Studies, AMAG shall be responsible for using Commercially Reasonable Efforts to conduct (1) all studies that are required after the Effective Date by a Regulatory Authority in the Licensed Territory as a condition for approval of the MAA for iron deficiency anemia associated with

chronic kidney disease and/or for the IDA Indication or for appropriate reimbursement of the Product, and (2) to the extent agreed by the JDC and approved by the JSC, subject to Section 14.2, all studies that are recommended after the Effective Date by a Regulatory Authority in the Licensed Territory for approval of the MAA for the Product ((1) and (2), collectively, the “ Future Required Studies ”), subject to Sections 4.4(c)(ii) and (iii) and 4.9(b), unless agreed otherwise by the Parties. For clarity, an MAA for a patient population for which a previous MAA was not filed will be considered to be an MAA for a distinct Indication. AMAG shall have the right to use any and all data and results generated from the Future Required Studies for any and all purposes outside the Licensed Territory. For the avoidance of doubt, Takeda shall have the right to use data from the Future Required Studies included in the AMAG Technology for the purposes of obtaining and maintaining Regulatory Approval for the Product in the Licensed Territory in accordance with the terms of this Agreement. AMAG shall use Commercially Reasonable Efforts to timely conduct all Development activities for the Future Required Studies as set forth in the then-current Development Plan.

(ii) If Takeda desires to conduct any Future Required Studies in a country outside of Europe through its sublicensee of commercial rights in such country, Takeda shall notify AMAG, and the Parties shall meet and discuss in good faith the qualifications of such sublicensee to conduct such activities and a budget for such activities, as well as AMAG’s qualifications and budget for such activities. Takeda shall have the right to conduct such activities through such sublicensee if such sublicensee is reasonably qualified (based on local requirements and capabilities) and if such budget is reasonably similar to AMAG’s budget for such activities.

(iii) In the event that AMAG materially fails to perform a Future Required Study consistent with the then-current Development Plan (such failure referred to herein as a “ Future Required Study Failure ”) Takeda shall have the right to allege a Future Required Study Failure by written notice to AMAG, such notice to set forth the basis for such alleged failure in reasonable detail. AMAG shall have a period of [***] to cure such failure to Takeda’s reasonable satisfaction. If AMAG does not so cure such failure, then Takeda shall have the right to conduct the Future Required Study to which the material failure pertains in accordance with the then-current Development Plan as reasonably amended by Takeda, consistent with its obligation to use Commercially Reasonable Efforts under Section 4.7, to mitigate the consequences of such failure. Takeda shall provide such amended Development Plan to the JDC promptly after preparation thereof. Upon Takeda’s exercise of such right, AMAG shall provide Takeda with its then-current budget for the Out-of-Pockets Costs for the applicable study and any supporting material reasonably requested by Takeda to the extent necessary or useful for Takeda to conduct such studies. If Takeda conducts such studies, AMAG shall, at its expense, take all actions reasonably required to transfer such responsibility to Takeda in a timely, efficient and effective manner, including the responsibility for procuring the

manufacture and supply of the necessary Product for the clinical trials and/or the management of the related clinical trials, which AMAG shall facilitate by introducing Takeda to AMAG’s Third Party CROs and, upon Takeda’s request, using reasonable efforts to assign to Takeda any Third Party contracts to the extent related to the clinical trials. Upon the [***] of a Future Required Study Failure, Takeda shall have the right to assume responsibility for and conduct the Future Required Study to which such failure pertains as provided above in this Section 4.4(c)(iii), notwithstanding AMAG’s timely cure of such Future Required Study Failure.

4.5 Other AMAG Studies . AMAG may not conduct any studies of the Product for use outside the Licensed Territory that would be likely to have a material adverse impact on the product profile, safety or efficacy of the Product in the Field in the Licensed Territory. As provided in Section 3.2(c), AMAG shall notify the JDC of its intent to conduct any studies of the Product (other than the Initial Studies, Future Required Studies, U.S. Studies or Pediatric Studies) that AMAG intends to use in obtaining or maintaining Regulatory Approval outside the Licensed Territory in the Field and under which AMAG may grant Takeda rights (the “ Other AMAG Studies ”), at the first JDC meeting following AMAG’s decision to conduct such studies. Takeda shall have the right to use data from an Other AMAG Study included in the AMAG Technology only if Takeda bears a share of the costs and expenses for such study as provided in Section 4.9(c). Upon Takeda’s request, AMAG shall provide Takeda with a reasonably detailed plan and budget for the conduct of such Other AMAG Study. At any time between receipt of such plan and budget and completion (i.e., delivery of the final study report) of the Other AMAG Study, Takeda shall have the right to elect to opt in to such Other AMAG Study by providing written notice to AMAG. Upon such election, Takeda shall [***], such Other AMAG Study shall be a “ Takeda Opt-In Study ”, and such Takeda Opt-In Study shall be included in the Development Plan. AMAG shall use Commercially Reasonable Efforts to conduct such Takeda Opt-In Study in accordance with the Development Plan.

4.6 Takeda Product Development . Takeda may, in its sole discretion, conduct studies of the Product for the purpose of obtaining or maintaining Regulatory Approval or for Commercializing the Product in the Licensed Territory that are not Future Required Studies, such as Phase 4 Clinical Trials in the Licensed Territory, in which it may grant AMAG rights (the “ Takeda Studies ”); provided, however, that Takeda may not conduct any such studies that would be likely to have a material adverse impact on the product profile, safety or efficacy of the Product in the Field outside the Licensed Territory. AMAG shall have the right to use data from a Takeda Study only if AMAG bears a share of the costs and expenses for such study as provided in Section 4.9(c). As provided in Section 3.2(c), Takeda shall notify the JDC of its intent to conduct a Takeda Study at the first JDC meeting following Takeda’s decision to conduct such study. Upon AMAG’s request, Takeda shall provide AMAG with a reasonably detailed plan and budget for the conduct of such Takeda Study. At any time between receipt of such plan and budget and completion (i.e., delivery of the final study report) of the Takeda Study, AMAG shall

have the right to elect to opt in to such Takeda Study, by providing written notice to Takeda. Upon such election, AMAG shall [***], such Takeda Study shall be an “ AMAG Opt-In Study ”, and such AMAG Opt-In Study shall be included in the Development Plan. Takeda shall use Commercially Reasonable Efforts to conduct such AMAG Opt-In Study in accordance with the Development Plan.

4.7 Development Diligence . Takeda shall use Commercially Reasonable Efforts to Develop (either through AMAG, a Third Party sublicensee or by Takeda or its Affiliates with respect to a study that Takeda conducts or assumes) and seek Regulatory Approval of the Product for use in the Field throughout the Licensed Territory in accordance with the terms and conditions of this Agreement. Takeda shall conduct all Development activities that Takeda assumes in accordance with the then-current Development Plan. With respect to any country in the Licensed Territory for which Takeda has not initiated Development activities or the Development Plan has not included activities for such country, Takeda shall use Commercially Reasonable Efforts to determine whether to conduct Development activities and seek Regulatory Approval for the Product in such country.

4.8 Reports. The Parties shall discuss the status, progress and results of each Party’s Development activities under the Development Plan at meetings of the JDC. In addition, each Party shall update the JDC at each meeting on all Development activities such Party is conducting for the Product outside the scope of the Development Plan. Upon any discontinuation of the JDC pursuant to Section 3.3(d), each Party shall keep the other party informed as to progress of the Development activities for the Product by providing such other Party with written quarterly reports summarizing the work performed and the timelines regarding such activities.

4.9 Development Costs.

(a) Initial Studies, U.S. Studies, Pediatric Studies .

(i) Subject to Sections 4.9(a)(ii), 4.9(a)(iii) and 4.9(b)(i), AMAG shall be solely responsible for all costs and expenses it incurs to conduct the Initial Studies, U.S. Studies and Pediatric Studies. AMAG acknowledges that based on Regulatory Authority communications as of the Effective Date, the Initial Studies are highly beneficial to support Regulatory Approval and Commercialization in the Field in the Licensed Territory. AMAG shall keep complete and accurate records of all Out-of-Pocket Costs it incurs to conduct the Initial Studies.

(ii) If Takeda assumes responsibility for an Initial Study pursuant to Section 4.4(a)(ii), [***], Within thirty (30) days after the end of each calendar quarter during which Takeda is conducting an Initial Study, Takeda shall provide the JDC with a reasonably detailed statement setting forth all [***].

(iii) [***]

(b) Changes to Initial Studies, U.S. Studies, Pediatric Studies; Future Required Studies .

(i) [***] All Development activities conducted by a Party for an Increase in Scope shall be in accordance with the Development Plan, and the other Party shall have the right to use the resulting data pursuant to the licenses granted in this Agreement.

(ii) Within thirty (30) days after the end of each calendar quarter during which AMAG, Takeda and/or Takeda’s sublicensee is conducting Development activities resulting from an Increase in Scope, AMAG and/or Takeda, as applicable, shall provide the JDC with a reasonably detailed statement setting forth [***].

(c) Opt-In Studies . Within thirty (30) days after the end of each calendar quarter in which an AMAG Opt-In Study or Takeda Opt-In Study (each, an “ Opt-In Study ”) is conducted, the Party conducting such Opt-In Study shall provide the other Party with a reasonably detailed statement setting forth all Out-of-Pocket Costs it incurred in such calendar quarter to conduct such Opt-In Study, and an invoice for such other Party’s share of such costs. In addition, if such invoice is the first invoice for such Opt-In Study following the non-funding Party’s election to opt in to such study, the Party conducting the Opt-In Study shall include in such invoice the other Party’s share of all Out-of-Pocket Costs previously incurred to conduct such Opt-In Study. The other Party shall pay each such invoice within thirty (30) days after receipt thereof; provided, however, that [***].

4.10 Delayed Opt-In. If Takeda fails to elect to pay a portion of the Out-of-Pocket Costs for the conduct of any Other AMAG Study under Section 4.5, or if AMAG fails to elect to pay a portion of the Out-of-Pocket Costs for the conduct of any Takeda Study under Section 4.6, in each case within the applicable time period, then within thirty (30) days after completing any such study, the Party conducting such study shall provide the other Party with (a) a summary of all data and results generated from such study, and (b) a reasonably detailed statement setting forth all Out-of-Pocket Costs incurred to conduct such study (the “ Opt-In Costs ”). Within sixty (60) days after receiving such summary and statement, the non-funding Party shall have the right to opt in to such study, upon which such study shall become a Takeda Opt-In Study or AMAG Opt-In Study, as applicable, by providing irrevocable written notice to the funding Party and [***]. Upon such opt in, the Party opting in shall have the right to use all results, data and other

Information generated under such study for all purposes relating to Development and Commercialization of the Product in its respective territory (i.e., the Licensed Territory in the case of Takeda under the licenses granted herein and outside the Licensed Territory in the case of AMAG), and such data and results shall thereafter be included within the definition of the other Party’s Know-How for purposes of the licenses granted in Article 2.

4.11 Data Exchange and Use.

(a) Initial Studies, U.S. Studies, Pediatric Studies and Future Required Studies . AMAG shall promptly provide Takeda with copies of all data and reports with respect to the conduct of each Initial Study, U.S. Study, Pediatric Study and Future Required Study as such data and reports become available. Takeda acknowledges and agrees that AMAG may share any and all such Information with AMAG’s Affiliates and Third Party collaborators and that AMAG and such Affiliates and collaborators may use, free of charge, any such data for developing and commercializing the Product outside the Licensed Territory or outside the Field, including associated regulatory activities, subject to the rights granted to Takeda under this Agreement for the Product in the Field and in the Imaging Field (subject to Section 2.4) in the Licensed Territory. Takeda shall have the right to use all results, data and other Information generated under each such study for all purposes relating to Development and Commercialization of the Product in the Field in the Licensed Territory, and such data and results shall be AMAG Know-How subject to the licenses granted to Takeda in Section 2.1, subject to [***]. For the avoidance of doubt, if Takeda conducts any such study, AMAG shall have the right to use all results, data and other Information generated under such study for all purposes relating to Development, Manufacture and Commercialization of the Product outside the Licensed Territory, and such data and results shall, to the extent not included in the Product Inventions, be Takeda Know-How subject to the licenses granted to AMAG in Section 2.2.

(b) Takeda Studies and Other AMAG Studies . With respect to the Takeda Studies and the Other AMAG Studies, notwithstanding the licenses granted in Sections 2.1 and 2.2, the non-funding Party shall have no rights to use any data resulting from, or reference any Regulatory Materials relating to, any such study (and it shall not be included within the definition of the funding Party’s Know-How or Patents), except with respect to safety or other information necessary to support such non-funding Party’s adverse event reporting requirements with Regulatory Authorities in its respective territory (i.e., outside the Licensed Territory for AMAG, and the Licensed Territory for Takeda), unless and until such non-funding Party opts in under the terms of Section 4.5, 4.6 or 4.10. Following an opt-in, the Party opting in shall have the right to use all results, data and other Information generated under the applicable Opt-In Study for all purposes relating to Development and Commercialization of the Product in its territory (i.e., the Licensed Territory for Takeda, and outside the Licensed Territory for AMAG),

and such data and results shall thereafter be included within the definition of such Party’s Information and Patents for purposes of the licenses granted in Article 2.

(c) Ownership of Information . All data and reports disclosed by one Party to the other under this Agreement shall be deemed Confidential Information of the disclosing Party, subject to Articles 9 and 12 and the permitted uses and disclosures described in this Section 4.11 and disclosure to any Regulatory Authority in connection with a Party’s obligations under Article 5.

4.12 Cooperation; Compliance with Laws. Each Party shall conduct its activities under this Agreement in good scientific manner and in compliance in all material respects with all applicable Laws, including applicable national and international ( e.g. , ICH, GCP, GLP, GPvP, and GMP) guidelines.

4.13 Records, Reports and Information . Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other Information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner appropriate for regulatory purposes. Each Party shall document all non-clinical Studies and clinical trials in formal written study reports according to applicable national and international ( e.g. , ICH, GCP, GLP, GPvP, and GMP) guidelines. Subject to restrictions on data access under Section 4.11, each Party shall have the right to review such records, including trial management files, maintained by the other Party at reasonable times, upon written request, which shall not exceed once a year.

ARTICLE 5

REGULATORY MATTERS

5.1 Data and Information Transfer.

(a) Initial Data Transfer. As soon as practicable but not later than three (3) months after the Effective Date, AMAG shall provide Takeda (i) copies of all filings contained within the Regulatory Materials of AMAG generated as of the Effective Date and relating to the Product in the Field and relevant to the Licensed Territory, and (ii) access to the clinical databases and copies of the study reports from those clinical trials set forth on Schedule 5.1 , including any updates to such databases and reports as such updates become available to AMAG, to the extent that they relate to the Product in the Field.

(b) CMC Information. Notwithstanding anything to the contrary in this Agreement or the Supply Agreement, AMAG shall disclose Information related to CMC for the Product and necessary to support Regulatory Approvals (“ CMC Information ”) to Takeda only to the extent that Takeda requires such CMC Information to comply with applicable Laws, and only to those certain individuals designated to receive CMC Information on behalf of Takeda (the “ CMC Recipients ”). The CMC Recipients shall not have the right to disclose CMC Information to any other Takeda personnel. To the extent applicable in any regulatory

jurisdiction in the Licensed Territory, AMAG shall have the right to timely file or otherwise provide CMC Information directly to a Regulatory Authority, and Takeda shall reasonably cooperate with AMAG in any such filing. If a regulatory jurisdiction does not provide a procedure whereby AMAG may directly submit such CMC Information, then AMAG shall provide to the CMC Recipients the relevant CMC Information, and Takeda shall have the right to file any such CMC Information to the extent required by applicable Laws, subject to the terms of this Section 5.1(b). To the extent that Takeda provides any such CMC Information to a Regulatory Authority, Takeda shall disclose only what is required to be disclosed, shall take reasonable measures to protect the confidentiality of such Information to the extent permitted by a Regulatory Authority, and shall not disclose any such Information without AMAG’s prior written approval of the form and content of such disclosure except to the extent required by a Regulatory Authority. In addition, notwithstanding Article 12, Takeda shall not have the right to disclose such CMC Information as provided in Section 12.1, and instead shall have the right to disclose such information only to a Regulatory Authority under the terms of this Section 5.1(b).

5.2 Regulatory Responsibilities.

(a) The Party with primary responsibility for preparing, filing and holding Regulatory Materials for the Product in a particular country or territory in the Licensed Territory with respect to the Product shall be referred to as the “ Regulatory Lead ”. Subject to Section 14.2(b)(ii), AMAG shall be the Regulatory Lead for the Product with respect to the EMA, Swissmedic and Health Canada, unless and until Takeda elects to assume such responsibility pursuant to Section 5.2(b). Takeda, or its sublicensee(s), pursuant to Section 2.1(c)(ii) and (iii), shall be the Regulatory Lead for the Product in all other countries in the Licensed Territory, unless the Parties mutually agree that AMAG shall be the Regulatory Lead in any such country. Except as provided in Section 5.2(f), the Regulatory Lead with respect to a particular territory shall be the sole owner of and shall hold in its name all Regulatory Materials for the Product in such territory; provided, however, that Takeda shall solely own all promotional materials for the Product throughout the Licensed Territory. The Regulatory Lead shall cooperate with the other Party, through the JDC or other committee or subcommittee formed by the Parties, in conducting its activities under this Article 5.

(b) Takeda shall have the right, upon reasonable advance written notice to AMAG, but in no event less than [***] written notice, to become the Regulatory Lead for the Product with respect to the EMA, Swissmedic and/or Health Canada; provided that Takeda shall become the Regulatory Lead for the Product with respect to the EMA, Swissmedic and Health Canada as soon as reasonably practicable but not later than First Commercial Sale of the Product in Europe. Upon Takeda’s becoming Regulatory Lead, the Parties shall establish a timeframe for AMAG to transfer and assign to Takeda all Regulatory Materials for the Product with respect to the EMA, Swissmedic and/or Health Canada, including the IND for the Product with respect to

the EMA, Swissmedic and/or Health Canada. In accordance with such timeframe, the Parties shall execute such documents and take such actions as are reasonably necessary to effectuate the foregoing transfer and assignment of such Regulatory Materials. Takeda shall be responsible for all reasonable Out-of-Pocket Costs incurred for such transfer and assignment.

(c) Takeda and AMAG shall, through the JDC, establish the regulatory strategy for the Product in the Licensed Territory, including a plan and schedule of regulatory activities to be performed by the Parties in connection with obtaining approval for the initial MAA for the Product in the Licensed Territory and for amendments or supplements thereto. In establishing such strategy, the JDC shall discuss each Party’s interpretation of applicable regulatory guidance, regulatory precedents, scientific advice and study data. Each Party shall assist and cooperate with the other Party as such other Party may reasonably request in connection with the preparation and filing of such Regulatory Materials in a timely manner.

(d) The Regulatory Lead shall provide the other Party with copies of any proposed Regulatory Materials to be submitted (other than routine correspondence) at least ten (10) business days in advance of submission and shall reasonably consider any comments thereto provided by the other Party, to the extent practicable.

(e) The Regulatory Lead shall inform each applicable Regulatory Authority in the Licensed Territory that two (2) representatives of the other Party will attend and, to the extent permitted by applicable Laws, participate in all major meetings between the Regulatory Lead and such Regulatory Authority, subject to the confidentiality provisions set forth under Article 12. The Regulatory Lead shall timely inform the other Party of any such scheduled meetings, as soon as practicably possible.

(f) AMAG, in consultation with Takeda, shall be primarily responsible for the preparation of any components of Regulatory Materials to be filed by Takeda that relate to the Manufacture of Product and for communicating with Regulatory Authorities in the Licensed Territory regarding Manufacture of Product. Takeda shall provide AMAG with at least [***] notice of any intended filing date of Regulatory Materials containing components to be prepared by AMAG. Takeda shall cooperate with AMAG and take such actions as AMAG may reasonably request in connection with the foregoing activities and communications as related to the Manufacture of Product for the Licensed Territory.

5.3 Regulatory Costs and Expenses . [***]

5.4 Preparation of Regulatory Materials. The Parties shall use Commercially Reasonable Efforts, in compliance with applicable Laws and other regulatory obligations related to Development and Regulatory Approval in the Licensed Territory, to prepare and file the

appropriate Regulatory Materials for those countries for which Regulatory Approval is sought under this Agreement.

5.5 Rights of Reference to Regulatory Materials . Each Party hereby grants to the other Party a right of reference to all Regulatory Materials filed by such Party for the Product subject to the scope of the licenses granted under Sections 2.1 and 2.2, including, for the avoidance of doubt, all such Regulatory Materials filed by AMAG for Regulatory Approval of the Product in the United States and all supplemental filings related thereto, and all “Certificate(s) of Pharmaceutical Product” and/or “Certificate(s) of Free Sales” resulting from Regulatory Approval of such Product, solely for the purpose of seeking, obtaining and maintaining Regulatory Approvals for, and the Commercialization of, the Product in the Licensed Territory and the Field, consistent with the roles of the Parties set forth in this Agreement; provided, however, that such right of reference shall not include any Regulatory Materials to the extent related to an Other AMAG Study that is not a Takeda Opt-In Study. In addition, Takeda hereby grants to AMAG a right of reference to all Regulatory Materials filed by Takeda in the Licensed Territory for the purpose of AMAG, its Affiliates or any Third Party partners or licensees developing and obtaining and/or maintaining regulatory approvals anywhere in the world for the Product in the Field outside the Licensed Territory; provided, however, that such right of reference shall not include any Regulatory Materials to the extent related to a Takeda Study that is not an AMAG Opt-In Study.

5.6 Adverse Event Reporting and Safety Data Exchange . The Parties agree that each Party will be responsible for the monitoring of all clinical experiences for any clinical trial it conducts. AMAG will be responsible for maintaining the global safety database and filing all required reports for the Product to Regulatory Authorities outside the Licensed Territory throughout the Development of the Product. Takeda will be responsible for filing all required reports for the Product to the Regulatory Authorities in the Licensed Territory throughout the Development of the Product, and if AMAG is the Regulatory Lead, AMAG shall cooperate with Takeda as necessary for Takeda to comply with applicable regulatory requirements. Each Party shall have the right to review all such information and reports prepared or maintained by the other Party at reasonable times, upon prior written request. The Parties shall cooperate to develop methods and/or procedures for sharing safety information relating to such clinical experiences in accordance with safety reporting requirements of the respective Regulatory Authorities and as necessary for a Party to comply with applicable Laws. In connection with such discussions, the Parties may convene any joint working groups in the subject matter to provide recommendations to the Parties. Specific details regarding the sharing and management of information of adverse events related to the Development and the Commercialization of the Product both within and outside the Licensed Territory will be delineated in a separate pharmacovigilance and safety data exchange agreement (the “ Pharmacovigilance Agreement ”) that shall be agreed to by the Parties by the earlier of three (3) months after the Effective Date or one (1) month from the IND. Until the Pharmacovigilance Agreement is signed, AMAG shall provide Takeda with AMAG’s quarterly summary, when prepared by AMAG, of AMAG’s monitoring of all clinical experiences for trials of the Products, and such additional related details as reasonably requested by Takeda to evaluate the information contained in the summary. The Parties agree that the Pharmacovigilance Agreement shall set forth the procedures by which each Party shall report

and maintain safety data and prescription events monitoring, and shall contain customary terms for such an agreement no less stringent than those required by ICH guidelines, applicable Laws and applicable local regulatory requirements.

5.7 Regulatory Authority Communications Received by a Party . Each Party shall keep the other Party informed in a timely manner compliant with the reporting requirements of Regulatory Authorities in the Licensed Territory, but in any event within five (5) business days or such shorter time period set forth in the Pharmacovigilance Agreement and/or SOPs, of notification of any action by, or notification or other information which it receives (directly or indirectly) from, any Regulatory Authority that: (i) raises any material concerns regarding the safety or efficacy of the Product; (ii) indicates or suggests a potential material liability of either Party to Third Parties in connection with the Product; (iii) is reasonably likely to lead to a recall or market withdrawal of the Product or a discontinuation of clinical studies for the Product; or (iv) relates to expedited and periodic reports of adverse events with respect to the Product, or Product Complaints, and in each case which may have a material impact on Regulatory Approval or the continued Commercialization of the Product anywhere in the world. The other Party will fully cooperate with and assist such Party in complying with regulatory obligations and communications, including by providing to such Party, in a timely manner after a request, such information and documentation in the other Party’s possession as may be necessary or helpful for the Party to prepare a response to an inquiry from a Regulatory Authority. Each Party will provide the other Party in a timely manner with a copy of all correspondence received from a Regulatory Authority specifically regarding the matters referred to above. The Pharmacovigilance Agreement shall set forth the procedures by which each Party shall report and maintain safety data and prescription events monitoring. In addition to the foregoing and subject to applicable Laws, AMAG shall promptly provide Takeda with a copy of all material correspondence received from the FDA and any material reply correspondence by AMAG, in each case that is reasonably likely to have a material impact on the Development, Manufacture and/or Commercialization of the Product in the Licensed Territory; provided that AMAG may redact AMAG’s Confidential Information (including CMC Information) from any such correspondence provided to Takeda, and if required by a Regulatory Authority in the Licensed Territory, AMAG shall submit any such redacted correspondence, without redactions, directly to such Regulatory Authority and not to Takeda The Parties shall determine as soon as reasonably practicable after the Effective Date what types of regulatory correspondence shall be considered “material”. In the event a material correspondence relating to CMC Information occurs, the Parties shall cooperate to adequately and appropriately address the matter and, if and only to the extent necessary, AMAG shall disclose the subject CMC information to the CMC Recipients, who shall not disclose it to any other Takeda personnel.

5.8 Regulatory Safety Reporting . Each Party shall be permitted, and have the right, to perform pharmacovigilance activities and/or make such safety reports to applicable Regulatory Authorities, to comply with applicable Laws, international best practices for pharmacovigilance activities and/or other activities that the Party, in its reasonable and good faith judgment, believes necessary for the health, safety and protection of patients and/or clinical trial subjects. The Parties shall use good faith efforts to agree to one opinion with respect to safety issues and to report said opinion to safety boards of any nature, investigators, and to applicable

Regulatory Authorities; provided, however, nothing in this Section 5.8 shall limit either Party’s right to report safety matters to Regulatory Authorities in its applicable territory.

5.9 Audit . If a Regulatory Authority desires to conduct an inspection or audit of a Party’s facility or a facility under contract with such Party with regard to the Product, then the audited Party shall notify the other Party within [***] days, or if not possible within such time period, then as soon as practicably possible, after receipt of such notification of such audit or inspection and provide copies of any materials provided to it by the applicable Regulatory Authority; provided, that the audited Party shall not be required to notify the other Party of audits or inspections that are of a routine nature or that do not relate to the Product or the Field, except where such audits result in communications or actions of such Regulatory Authority which have an impact upon the Product. The audited Party shall cooperate, and shall use reasonable efforts to cause the contract facility, if any, to cooperate, with such Regulatory Authority and the other Party during such inspection or audit. Following receipt of the inspection or audit observations of such Regulatory Authority (a copy of which the audited Party will immediately provide to the other Party), the audited Party will also provide the other Party with copies of any written communications received from Regulatory Authorities with respect to such facilities in a timely manner after receipt, to the extent such written communications relate to the Product or the Manufacture thereof, and will prepare the response to any such observations; provided that AMAG may redact CMC Information from any such written communications provided to Takeda. The audited Party will provide the other Party with a copy of any proposed response to such communications and will implement such other Party’s reasonable comments with respect to such proposed response; provided that AMAG may redact CMC Information from any such proposed response provided to Takeda. The audited Party agrees to conform its activities under this Agreement to any commitments made in such a response. In the event a Product Complaint relating to CMC Information occurs, the Parties shall cooperate to adequately and appropriately resolve the Product Complaint and, if and only to the extent necessary, AMAG shall disclose the subject CMC information to the CMC Recipients, who shall not disclose it to any other Takeda personnel.

ARTICLE 6

COMMERCIALIZATION

6.1 Overview of Commercialization in the Licensed Territory . Subject to the terms and conditions of this Article 6, as between the Parties, Takeda will be responsible for all aspects of the Commercialization of the Product in the Field in the Licensed Territory, including but not limited to: (a) developing and executing a commercial launch and pre-launch plan, (b) marketing and promotion; (c) booking sales and distribution and performance of related services; (d) handling all aspects of order processing, invoicing and collection, inventory and receivables;

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

(e) providing customer support, including handling medical queries, and performing other related functions; and (f) conforming its practices and procedures in all material respects to applicable Laws relating to the marketing, detailing and promotion of the Product in the Field in the countries of the Licensed Territory. Takeda shall bear all of the costs and expenses incurred in connection with all such Commercialization activities.

6.2 Commercialization Plan for Licensed Territory . Takeda shall prepare and submit to the JSC for review and comment a detailed plan for Commercialization of the Product in the Licensed Territory (the “ Commercialization Plan ”). The Commercialization Plan will include projections, timelines and a reasonably detailed description of Takeda’s Commercialization activities, including Product life cycle management, market research, sales training, distribution channels, customer service and sales force matters related to the launch and sale of the Product in the Field and in the Licensed Territory, but excluding Manufacturing. The initial Commercialization Plan shall be delivered to the JSC not later than [***]. On at least an annual basis, Takeda shall update and amend, as appropriate, the then-current Commercialization Plan. Takeda shall submit all updates and amendments to the Commercialization Plan to the JSC for review and comment. AMAG, at its sole discretion, shall assist Takeda, if reasonably requested by Takeda, in preparing and developing the strategy for commercial Product positioning and messaging for the Product for the Licensed Territory, under oversight by the JSC.

6.3 Pricing. Takeda shall have the sole right to determine all pricing of the Product in the Licensed Territory in the Field. Notwithstanding anything in this Agreement express or implied to the contrary, AMAG shall not have any right to direct, control, or approve Takeda’s pricing of the Product for the Licensed Territory in the Field. The provision to AMAG of any pricing data in connection with the Commercialization Plan, which shall occur only if permitted by applicable Laws, is for informational purposes only.

6.4 Commercial Diligence .

(a) Takeda shall use Commercially Reasonable Efforts to Commercialize the Product in the Field in each country in the Licensed Territory in accordance with this Agreement following Regulatory Approval of the Product in such country.

(b) Without limiting Takeda’s obligation under subsection (a), Takeda shall achieve First Commercial Sale of the Product in each country of [***]; provided that failure to achieve such First Commercial Sale within such time shall not be a breach of this Agreement to the extent directly attributable to existence of the following conditions and only for so long as such conditions remain in effect: (i) AMAG’s breach of its obligations under this Agreement; (ii) a determination by Takeda in its discretion in good faith (and after consultation with AMAG)

to delay the First Commercial Sale of the Product [***] if the Product label is impaired or restricted, or if price reimbursement is deemed to be not commercially viable; or (iii) force majeure events as and to the extent set forth in Section 16.2.

6.5 Reports . In addition to Takeda’s obligations under Section 6.2, Takeda shall update the JSC at each meeting with respect to lifecycle management of the Product and its significant Commercialization activities with the Product in the Licensed Territory. Each such update shall be in a form to be agreed by the JSC and shall summarize Takeda’s significant Commercialization activities with respect to the Product in the Licensed Territory pursuant to this Agreement, include a forecast for the following year’s sales of the Product in the Licensed Territory, and describe major activities with respect to the distribution and sales channels for the Product.

6.6 Tracking Sales of Product in the Field and Outside the Field.

(a) Measurement; Payment . The Parties recognize the possibility that customers or other Third Parties may purchase a Product sold by AMAG or a Third Party that has received Regulatory Approval in the Licensed Territory for use outside the Field and is sold for use outside the Field (a “ Non-Field Product ”) and use such Non-Field Product off-label in the Field in the Licensed Territory (such use being the “ Off-label Use of Non-Field Product ”). If Takeda believes that Off-label Use of Non-Field Product is occurring in any country in the Licensed Territory, Takeda may notify the JSC, providing reasonable evidence for such belief (such as data from a commercially available prescription claims database). The JSC shall promptly thereafter meet to discuss such evidence and establish a mechanism to track sales of such Non-Field Product in the Licensed Territory [***].

(b) Dispute Resolution . If the JSC cannot agree on: (i) the process and methodology to be implemented by the Parties in tracking sales of Non-Field Products in the Licensed Territory, (ii) the extent of Off-label Use of Non-Field Product, or [***], then in each such case, at the election of either Party, the Parties shall resolve such dispute in accordance with the provisions of Exhibit F .

6.7 Product Trademarks and House Marks.

(a) Product Trademarks . The JSC shall determine the Product-related trademarks to be used in connection with Commercializing the Product in the Licensed Territory, and shall give due consideration to the AMAG Product Marks. Takeda may submit to the JSC for review, comment, and approval proposed trademarks different from or in addition to the AMAG Product Marks for use in a country or region in the Licensed Territory. Subject to JSC approval, Takeda shall amend the Commercialization Plan to include any such new trademarks. Takeda shall own all right, title, and interest in and to all trademarks developed by either Party

under this Agreement after the Effective Date for use in connection with Commercializing the Product in the Licensed Territory (the “New Product Marks” ). Takeda shall be solely responsible, at its expense, for filing, prosecuting, maintaining, defending and enforcing the New Product Marks, provided, however, that Takeda shall provide AMAG reasonable opportunity to review and comment on such prosecution, maintenance, defense and enforcement of the New Product Marks. AMAG shall be solely responsible, at its expense, for filing, prosecuting, and maintaining the AMAG Product Marks, provided, however, that AMAG shall provide Takeda reasonable opportunity to review and comment on such prosecution, maintenance, defense and enforcement of the AMAG Product Marks with respect to the Licensed Territory.

(b) House Marks . To the extent allowable by applicable Laws, Product packaging, promotional materials and Product labeling for use in the Licensed Territory shall carry, (i) one or more of the AMAG House Marks, subject to Takeda’s reasonable approval of the size, position, and location thereof, and (ii) at Takeda’s sole discretion, one or more of Takeda’s trademarks or trade names (the “Takeda Marks” ). The Parties agree that the Takeda Marks and the AMAG House Marks shall be displayed under a general principle of co-prominence. AMAG shall own all right, title and interest in the AMAG House Marks and shall be solely responsible, at its expense, for filing, prosecuting, and maintaining the AMAG House Marks. Takeda shall own all right, title and interest in the Takeda Marks and shall be solely responsible, at its expense, for filing, prosecuting, and maintaining the Takeda Marks. Subject to the terms of this Agreement, AMAG hereby grants to Takeda a royalty-free, non-exclusive license to use and display the AMAG House Marks solely in connection with the Commercialization of the Product in the Field in the Licensed Territory. If pursuant to Section 6.7(a) AMAG Product Marks are selected by Takeda to be used in connection with Commercializing the Product in the Licensed Territory, AMAG hereby grants to Takeda a royalty-free, exclusive license to use and display such AMAG Product Marks solely in connection with the Commercialization of the Product in the Field in the Licensed Territory, subject to the terms of this Agreement. Such licenses may be sublicensed by Takeda to an Affiliate or a Third Party sublicensee of Takeda’s right to Commercialize the Product granted in Section 2.1(a)(i).

(c) Inspection . From time to time during the Term, upon AMAG’s reasonable request, Takeda shall provide AMAG with samples of the final finished Product sold by Takeda or its Affiliates or sublicensees in the Licensed Territory. AMAG shall use such Product samples solely to inspect the quality of such Products and use of the AMAG Product Marks and AMAG House Marks.

(d) No Inconsistent Acts. Takeda acknowledges AMAG’s exclusive ownership of the AMAG Product Marks and AMAG House Marks and agrees not to take any action inconsistent with such ownership. Takeda shall not use any AMAG Product Mark or AMAG House Mark in a way that would adversely affect its value. Takeda covenants that it shall not use any trademark confusingly similar to any AMAG Product Mark or AMAG House Mark in connection with any products (including the Product). Takeda shall comply with reasonable policies provided by AMAG from time to time to maintain the goodwill and value of the AMAG Product Marks and AMAG House Marks. AMAG acknowledges Takeda’s exclusive ownership of the New Product Marks and agrees not to take any action inconsistent with such

ownership and covenants that it shall not use in the Licensed Territory any trademark confusingly similar to any AMAG Product Mark and/or the New Product Mark used in connection with the Commercialization of the Product in or outside the Field in the Licensed Territory.

ARTICLE 7

MANUFACTURE AND SUPPLY

7.1 General Supply Terms . AMAG shall, itself or through one or more Third Party contract manufacturers, Manufacture the Product in finished form in unlabeled vials in accordance with the terms of Section 7.2, including the performance of all manufacturing process development and scale-up for the Product (and associated regulatory activities), and shall supply to Takeda, and Takeda shall purchase from AMAG, all of all of Takeda and its Affiliates’ and its/their sublicensees’ requirements of the Product for Development and Commercial activities as and to the extent set forth in this Agreement and the Supply Agreement. Takeda shall be responsible for labelling and packaging all Product supplied by AMAG to Takeda under the Supply Agreement.

7.2 Supply Agreement . On or before a date to be established by the JSC, the Parties shall enter into a supply agreement and quality agreement governing the supply of Product to Takeda in unlabeled finished form for clinical and commercial use, as well as the quality control and quality assurance procedures thereon (collectively the “ Supply Agreement ”) and any other operational agreements and procedures as deemed necessary by the Parties for such supply of the Product. The terms of such Supply Agreement shall be negotiated in good faith by the Parties in accordance with the terms of Schedule 7.2 .

7.3 Second Source. As of the Effective Date, the Parties have agreed to a summary plan for sourcing Product attached hereto as Schedule 7.3 (the “ Second Source Plan ”) for clinical and commercial use in the Licensed Territory from a Designated Second Source Supplier. AMAG shall perform its activities under the Second Source Plan on a timely basis. The Parties may amend the Second Source Plan from time to time upon mutual written agreement, with such agreement not to be unreasonably withheld. Takeda shall have the right under the Supply Agreement to obtain Product for use in the Licensed Territory in accordance with Schedule 7.2 .

7.4 Recalls and Voluntary Withdrawals . The Parties shall exchange their internal standard operating procedures (“ SOPs ”) for conducting product recalls reasonably in advance of the First Commercial Sale of Product in the Licensed Territory, and shall discuss and resolve any conflicts between such SOPs and issues relating thereto promptly after such exchange. If either Party becomes aware of information relating to any released Product that indicates that a unit or batch of Product may not conform to the specifications thereof, or that potential adulteration, misbranding, and/or other issues have arisen that relate to the safety or efficacy of such released Product, it shall promptly so notify the other Party. To the extent Takeda requires such information to comply with applicable Laws or to determine whether to conduct a recall, AMAG shall promptly disclose to the CMC Recipients any CMC Information related to such

nonconformance, adulteration, misbranding or other related issue. Takeda shall have the right, at its expense (except as provided herein), to control any Product recall, field correction, or withdrawal of any released Product in the applicable jurisdiction in the Licensed Territory; provided that prior to Takeda’s becoming Regulatory Lead with respect to EMA, Swissmedic and Health Canada, and for each country that the Parties agree that AMAG shall be the Regulatory Lead, in each case pursuant to Section 5.2, AMAG shall have the right to control any Product recall, field correction, or withdrawal of any released Product in the applicable jurisdiction and AMAG shall have the right to notify Takeda and request that such action be taken as a result of the manufacture of the Product. AMAG shall have the right, at its expense, to control any Product recall, field correction, or withdrawal of any released Product outside the Licensed Territory. AMAG shall be responsible for all costs incurred for any recall, field correction, or withdrawal of any released Product for the Licensed Territory to the extent such event of recall, field correction, or withdrawal is due to the breach by AMAG of this Agreement or the Supply Agreement. Takeda shall be responsible for all other costs incurred for any recall, field correction, or withdrawal of any released Product for the Licensed Territory. The procedures and consequences of such recalls shall be defined in the Supply Agreement. The Party having the right to control such recall pursuant to this Section 7.4 may, at its sole discretion, take appropriate courses of action, which shall be consistent with the internal SOPs of such Party; provided, however, that such controlling Party shall promptly notify the other Party of any recall action being considered and where practicable, consider the views of the non-controlling Party prior to taking any recall action. Takeda shall maintain complete and accurate records of any recall according to its then current SOPs in the Licensed Territory for such periods as may be required by applicable Laws, but in no event for less than three (3) years.

ARTICLE 8

COMPENSATION

8.1 Upfront Fee . Within [***] after the Effective Date and in partial consideration for the prior and future cost of developing the Product and Takeda’s rights in and to the AMAG Technology licensed hereunder, Takeda shall pay to AMAG a one-time upfront fee of sixty million Dollars ($60,000,000). Such fee shall be nonrefundable and non-creditable against any other payments due hereunder.

8.2 Development Milestone Payments . Takeda shall make milestone payments to AMAG based on achievement of certain milestone events for the Product as set forth in this Section 8.2, in partial consideration for the prior and future cost of developing the Product. Takeda shall pay to AMAG the amounts set forth below within [***] following the achievement of the corresponding milestone event. Except with respect to [***], each milestone payment by Takeda to AMAG hereunder shall be payable only once, regardless of the number of times

achieved by the Product. Each such payment is nonrefundable and non-creditable against any other payments due hereunder.

Milestone Event		Milestone Payment
[***]		[***]
[***]		[***]
[***]		[***]
[***]		[***]
[***]		[***]
[***]		[***]
[***]		[***]
[***]		[***]

[***]

8.3 Commercialization Milestone Payments in the Licensed Territory . Takeda shall make the following one-time, nonrefundable, non-creditable milestone payments to AMAG [***]. Takeda shall pay to AMAG such amount within [***]. For clarity, the milestone payments in this Section 8.3 shall be additive [***].

Milestone Event		Milestone Payment
[***]		[***]
[***]		[***]
[***]		[***]
[***]		[***]

8.4 Royalties .

(a) Royalty Rates during Royalty Term . Subject to Sections 8.4(b) and 8.4(d) below, and during the applicable Royalty Term, Takeda shall pay to AMAG a running royalty at the following incremental royalty rates on aggregate Net Sales of the Product during a Fiscal Year in the Licensed Territory.

Net Sales in the Licensed Territory		Tier Royalty Rate
For that portion of Net Sales in a Fiscal Year less than or equal to [***] (Tier 1)		[***]

For that portion of Net Sales in a Fiscal Year greater than [*] but less than or equal to [*] (Tier 2)		[***]

For that portion of Net Sales in a Fiscal Year greater than [*] but less than or equal to [*] (Tier 3)		[***]

For that portion of Net Sales in a Fiscal Year greater than [***] (Tier 4)		[***]

(b) [***]

(i) [***]

(ii) [***]

(iii) [***]

(iv) [***]

(v) [***]

(c) Clarification . Takeda acknowledges that it will continue to benefit from its license under, and the transfer to Takeda of certain elements of, the AMAG Technology and AMAG Product Marks pursuant to this Agreement (including the AMAG Know-How licensed to Takeda, and the regulatory data to be provided to Takeda pursuant to this Agreement) as well as from Takeda’s own development of Takeda Know-How derived from the practice of such license and Takeda’s use of such AMAG Technology, even after the expiration of all AMAG Patents claiming the Product in a particular country of the Licensed Territory. In addition, Takeda acknowledges that the application of a uniform royalty structure for the Licensed Territory throughout the Royalty Term, followed by a reduced royalty after the expiration of the Royalty Term pursuant to Section 8.4(e), is more convenient to the Parties, facilitates the payment of royalties, and reduces accounting burdens on the Parties, as compared with a royalty structure dependent on the expiration of AMAG Patents and use of AMAG Product Marks during and after the Royalty Term. Accordingly, the Parties have agreed to apply the same

royalty rate in the Licensed Territory throughout the Royalty Term, subject to Sections 8.4(b) and 8.4(d), and a reduced royalty following the Royalty Term. For the avoidance of doubt, the Net Sales of the Product in a country after the Royalty Term expires in such country shall not be included in the aggregate annual Net Sales for the calculation of a royalty pursuant to Section 8.4(a) or 8.4(b) and shall be used only to determine the royalty set forth in Section 8.4(e).

(d) Reduction of Royalty Following Entry of Generic Product . During the applicable Royalty Term, the royalty rates set forth in Section 8.4(a) for Net Sales in such country for a particular Product shall be reduced by [***] at the end of the first to occur [***] during which one or more Third Parties sells a number of equivalent units of a Generic Product of the applicable Product in such country of the Licensed Territory comprising, [***] of the aggregate combined number of equivalent units of such Product and such Generic Product(s) sold in such month in such country (“ Generic Entry ”). If in any month thereafter the number of equivalent units of Generic Product(s) sold decreases to [***] of the aggregate combined number of equivalent units of such Product and such Generic Product(s) sold in such month in such country, the royalty rate reduction set forth in this Section 8.4(d) shall no longer apply (unless and until the criteria set forth in the first sentence of this Section 8.4(d) again applies). All such determinations of unit volume shall be based upon a mutually acceptable calculation method and using market share (on unit number basis) data provided by a reputable and mutually agreed upon provider, such as IMS Health. By way of example, if [***], then the above mentioned royalty reduction shall apply.

(e) After Royalty Term . Following the expiration of the Royalty Term in any country of the Licensed Territory, Takeda shall pay to AMAG a royalty of [***] of Net Sales of such Product in such country.

8.5 Third Party Royalties.

(a) AMAG Obligations. AMAG will be responsible for all amounts owed to Third Parties after the Effective Date pursuant to agreements with Third Parties regarding the Product entered into prior to the Effective Date. AMAG also will be solely responsible for all amounts owed to Third Parties after the Effective Date (A) pursuant to any future license or technology acquisition agreement under which AMAG obtains rights to Third Party Patents or Information (i) claiming the composition of matter, use or manufacture of the Product as in existence as of the Effective Date; or (ii) covering AMAG’s Manufacture of the Product and (B) paid in settlement or final judgement of a claim that the composition of matter, use or manufacture of the Product as in existence as of the Effective Date or AMAG’s Manufacture of the Product infringes the Patent of such Third Party.

(b) Takeda Obligations . Except as provided in Section 8.5(a), Takeda will be solely responsible for all amounts owed to Third Parties after the Effective Date pursuant to

any future license or technology acquisition agreement under which Takeda obtains rights to Third Party Patents or Information related to the Development and Commercialization of the Product by Takeda, its Affiliates and their respective sublicensees in the Licensed Territory under this Agreement.

8.6 Royalty Reports and Payment . Within [***], Takeda shall provide AMAG with a report containing the following information for the applicable calendar month: the amount of gross sales of Product in the Licensed Territory, an itemized calculation of Net Sales in the Licensed Territory showing deductions, to the extent practicable, provided for in the definition of “Net Sales,” a calculation of the royalty payment due on such sales, an accounting of the number of units and prices for Product sold, the exchange rate for each country in which Product was sold, and [***] made in accordance with the terms of Section 8.4(b). Within [***], AMAG shall review and record such information as it determines necessary under its internal financial reporting procedures. Within [***], Takeda shall provide AMAG with a report containing the information described above in respect of such calendar quarter for AMAG’s review. In the event that either Party determines that the calculation of Net Sales for a calendar quarter deviates from the amounts previously reported to AMAG for any reason (such as, on account of additional amounts collected or Product returns), Takeda shall reasonably cooperate with AMAG to reconcile any such deviations to the extent necessary under applicable legal or financial reporting requirements. Within [***], Takeda shall pay all amounts due to AMAG pursuant to Section 8.4 with respect to Net Sales by Takeda, its Affiliates and their respective sublicensees for such calendar quarter. AMAG understands that some of the reductions may need annual review, so at the end of the each Fiscal Year, necessary reconciliation, if any, for true-up shall be made.

8.7 Foreign Exchange . The rate of exchange to be used in computing the amount of currency equivalent in Dollars owed to a Party under this Agreement shall be the quarterly average exchange rate between each currency of origin and Dollars as reported by Bloomberg on the last business day of the calendar quarter for which the relevant royalty payment applies.

8.8 Payment Method; Late Payments . All payments due to a Party hereunder shall be made in Dollars by wire transfer of immediately available funds into an account designated by such Party. If such Party does not receive payment of any sum due to it on or before the due date, simple interest shall thereafter accrue on the sum due to such Party until the date of payment at the per annum rate of [***].

8.9 Records; Audits . Each Party will maintain complete and accurate records in sufficient detail to permit (a) AMAG to confirm the accuracy of the calculation of royalty payments, and (b) with respect to any Increase in Scope, Takeda Opt-In Studies and AMAG Opt-In Studies, Takeda and AMAG to confirm the accuracy of the calculation of Out-of-Pocket Costs under this Agreement. Upon reasonable prior notice, such records shall be available during

regular business hours for a period of three (3) years from the end of the Fiscal Year to which they pertain for examination at the expense of the auditing Party, and not more often than once each calendar year, by an independent certified public accountant selected by the auditing Party and reasonably acceptable to the audited Party, for the sole purpose of verifying the accuracy of the financial reports and/or invoices furnished by the audited Party pursuant to this Agreement. Any such auditor shall not disclose the audited Party’s Confidential Information, except to the extent such disclosure is necessary to verify the accuracy of the financial reports furnished by such Party or the amount of payments due by or to such Party under this Agreement. Any amounts shown to be owed but unpaid shall be paid within thirty (30) days from the accountant’s report, plus interest (as set forth in Section 8.8) from the original due date. Any amounts shown to have been overpaid shall be refunded within thirty (30) days from the accountant’s report. The auditing Party shall bear the full cost of such audit unless such audit discloses an underpayment by the audited Party of more than five percent (5%) of the amount due, in which case the audited Party shall bear the full cost of such audit.

8.10 Taxes .

(a) Cooperation and Coordination . The Parties acknowledge and agree that it is their mutual objective and intent to appropriately calculate, to the extent feasible and legal, taxes payable with respect to their collaborative efforts under this Agreement and that they shall use all commercially reasonable efforts to cooperate and coordinate with each other to achieve such objective.

(b) Payment of Tax . A Party receiving a payment pursuant to this Article 8 shall pay any and all taxes levied on such payment. If applicable Laws require that taxes be deducted and withheld from a payment made pursuant to this Article 8, the remitting Party shall (i) deduct those taxes from the payment; (ii) pay the taxes to the proper taxing authority; and (iii) send evidence of the obligation together with proof of payment to the other Party within ninety (90) days following that payment.

(c) Tax Residence Certificate . A Party (including any entity to which this Agreement may be assigned, as permitted under Section 16.5) receiving a payment pursuant to this Article 8 shall provide the remitting Party appropriate certification from relevant revenue authorities that such Party is a tax resident of that jurisdiction, if such receiving Party wishes to claim the benefits of an income tax treaty to which that jurisdiction is a party. Upon the receipt thereof, any deduction and withholding of taxes shall be made at the appropriate treaty tax rate.

(d) Assessment . Either Party may, at its own expense, protest any assessment, proposed assessment, or other claim by any Governmental Authority for any additional amount of taxes, interest or penalties or seek a refund of such amounts paid if permitted to do so by applicable Laws. The Parties shall cooperate with each other in any protest by providing records and such additional information as may reasonably be necessary for a Party to pursue such protest.

ARTICLE 9

INTELLECTUAL PROPERTY MATTERS

9.1 Ownership of Inventions; Assignment. Each Party shall own all right, title, and interest in and to any inventions made solely by such Party’s employees, agents, independent contractors and sublicensees in the course of conducting its activities under this Agreement during the Term, together with all intellectual property rights therein, including any rights to applications or other protections for any of the foregoing. The Parties shall jointly own all inventions made jointly by the employees, agents, independent contractors or sublicensees of each Party, in accordance with joint ownership interests of co-inventors under U.S. patent laws (that is, each Party shall have full rights to license, assign and exploit such joint inventions (and any patents arising therefrom) anywhere in the world, without any requirement of gaining the consent of, or accounting to, the other Party), subject to the licenses granted herein and subject to any other intellectual property held by such other Party; provided, however, that Takeda shall not have the right to practice any jointly owned invention in any activities related to a product that competes with the Product. The Parties shall determine which Party will file, prosecute and maintain the Patents claiming or covering such jointly owned inventions. Inventorship shall be determined in accordance with U.S. patent laws. Notwithstanding the foregoing, Takeda agrees to assign and hereby assigns and transfers to AMAG all of its right, title and interest in and to any such solely owned or jointly owned inventions that relate to the composition of matter, manufacture or use of the Product (“ Product Inventions ”), and agrees to take, and to cause its employees, agents, consultants and sublicensees to take, all further acts reasonably required to evidence such assignment and transfer to AMAG, at AMAG’s reasonable expense. Takeda hereby appoints AMAG as its attorney-in-fact to sign such documents as AMAG deems necessary for AMAG to obtain ownership and to apply for, secure, and maintain patent or other proprietary protection of such Product Inventions if AMAG is unable, after reasonable inquiry, to obtain Takeda’s (or its employee’s or agent’s) signature on such a document. Takeda hereby waives, on behalf of itself, its parent, subsidiaries, Affiliates and partners as well as all of its employees and independent contractors, any rights of first refusal it, he, or she may have with respect to any contemplated technology transfer, in whole or in part, of the Product Inventions or any related patent, patent application, copyright or copyright application related thereto as well as any right accorded to it, him, or her, by statute or otherwise, to use any Product Invention or any Patent or copyright related thereto. All Patents claiming or covering any Product Invention shall be referred to herein as “ Product Patents .”

9.2 Disclosure of Inventions . Takeda shall, and shall cause its sublicensees to, promptly disclose to AMAG any invention disclosures, or other similar documents, submitted to it by its employees, agents or independent contractors describing inventions that may be Product Inventions, and all Information relating to such inventions to the extent necessary for the preparation, filing and maintenance of any Patent with respect to such invention.

9.3 Prosecution of Patents.

(a) AMAG Patents . AMAG shall have the sole right to prepare, file, prosecute and maintain the AMAG Patents at AMAG’s own costs and expenses. AMAG shall

provide Takeda reasonable opportunity to review and comment on such efforts regarding such AMAG Patents in the Licensed Territory, including by providing Takeda with a copy of material communications from any patent authority in the Licensed Territory regarding such AMAG Patent(s), and by providing drafts of any material filings or responses to be made to such patent authorities in advance of submitting such filings or responses. AMAG shall reasonably consider such comments by Takeda in connection with the prosecution of the AMAG Patents in the Licensed Territory. If AMAG determines in its sole discretion to abandon all claims in any AMAG Patent in the Licensed Territory, then AMAG shall provide Takeda with written notice of such determination within a period of time reasonably necessary to allow Takeda to determine its interest in such AMAG Patent(s). In the event Takeda provides written notice expressing its interest in obtaining such AMAG Patent(s), AMAG shall assign and transfer to Takeda the ownership of, and interest in, such AMAG Patent(s) in the Licensed Territory, such transfer to be at Takeda’s reasonable expense (but without payment to AMAG). Thereafter, Takeda shall bear [***] , and AMAG shall bear [***] of the costs of preparation, filing, prosecution and maintenance of such assigned and transferred Patents, which shall not be treated as AMAG Patents and shall be treated as Takeda Patents, and Takeda may prosecute such Takeda Patents at its sole discretion; provided, however, in the event that Takeda decides to abandon or not maintain any such Patent(s), Takeda shall promptly provide AMAG with written notice of such decision.

(b) Takeda Patents . Takeda shall be solely responsible to file, prosecute and maintain Takeda Patents. With respect to Takeda Patents under which AMAG receives a royalty-bearing license pursuant to Section 2.2 hereof, Takeda shall provide AMAG reasonable opportunity to review and comment on such prosecution efforts regarding such Takeda Patents, including by providing AMAG with a copy of material communications from any patent authority in the Licensed Territory regarding such Takeda Patent(s), and by providing drafts of any material filings or responses to be made to such patent authorities in advance of submitting such filings or responses. Takeda shall reasonably consider such comments by AMAG in connection with the prosecution of Takeda Patents.

9.4 Patent Term Extensions in the Licensed Territory . The JSC will discuss and recommend for which, if any, of the Patents within the AMAG Patents and Takeda Patents in the Licensed Territory the Parties should seek Patent Term Extensions in the Licensed Territory. AMAG, in the case of the AMAG Patents, and Takeda in the case of the Takeda Patents, shall have the final decision-making authority with respect to applying for any such Patent Term Extensions in the Licensed Territory, and will act with reasonable promptness in light of the development stage of the Product to apply for any such Patent Term Extensions, where it so elects; provided, however, that if in a particular country or jurisdiction in the Licensed Territory only one such Patent can obtain a Patent Term Extension, then the Parties will consult in good faith to determine which such Patent should be the subject of efforts to obtain a Patent Term Extension, and in any event AMAG’s decision on such matter will control in the case of a

disagreement. The Party that does not apply for an extension hereunder will cooperate fully with the other Party in making such filings or actions, for example and without limitation, by making available all required regulatory data and information and executing any required authorizations to apply for such Patent Term Extension. All expenses incurred in connection with activities of each Party with respect to the Patent(s) for which such Party seeks Patent Term Extensions pursuant to this Section 9.4 shall be entirely borne by such Party.

9.5 Infringement of Patents by Third Parties.

(a) Notification . Each Party shall promptly notify the other Party in writing of any existing or threatened infringement in the Licensed Territory of the AMAG Patents or Takeda Patents of which it becomes aware, and shall provide all evidence in such Party’s possession demonstrating such infringement.

(b) Infringement of AMAG Patents.

(i) If a Third Party infringes any AMAG Patent in the Licensed Territory by making, using, importing, offering for sale or selling the Product or a competitive product in the Field (a “ Product Infringement ”), each Party shall share with the other Party all Information available to it regarding such alleged infringement. Takeda shall have the first right, but not the obligation, to bring an appropriate suit or other action against any person or entity engaged in such Product Infringement in the Licensed Territory, subject to Sections 9.5(b)(ii) through 9.5(b)(v), below.

(ii) Takeda shall have a period of ninety (90) days after the first notice under Section 9.5(a) to elect to enforce such AMAG Patent against such Product Infringement. In the event Takeda does not so elect, Takeda shall so notify AMAG in writing, and AMAG shall have the right to commence a suit or take action to enforce the applicable Patent against such Third Party perpetrating such Product Infringement in the Licensed Territory at its own cost and expense. If one Party elects to bring suit or take action against the Product Infringement, then the other Party shall have the right, prior to commencement of the trial, suit or action, to join any such suit or action.

(iii) Each Party shall provide to the Party enforcing any such rights under this Section 9.5(b) reasonable assistance in such enforcement, at such enforcing Party’s request and expense, including joining such action as a party plaintiff if required by applicable Laws to pursue such action. The enforcing Party shall keep the other Party regularly informed of the status and progress of such enforcement efforts, shall reasonably consider the other Party’s comments on any such efforts, and shall seek consent of the other Party in any important aspects of such enforcement, including determination of litigation strategy and filing of important papers to the competent court, which shall not be unreasonably withheld or delayed.

(iv) Each Party shall bear all of its own internal costs incurred in connection with its activities under this Section 9.5(b).

(v) The Party not bringing an action with respect to a Product Infringement in the Licensed Territory under this Section 9.5(b) shall be entitled to separate representation in such matter by counsel of its own choice and at its own expense, but such Party shall at all times cooperate fully with the Party bringing such action.

(c) Infringement of Takeda Patents . For any and all infringement of any Takeda Patent anywhere in the Licensed Territory, Takeda shall have the sole and exclusive right, but not the obligation, to bring, at Takeda’s expense and in its sole control, an appropriate suit or other action against any person or entity engaged in such infringement of the Takeda Patent.

(d) Settlement . Each Party shall not settle any claim, suit or action that it brought under this Section 9.5 involving AMAG Patents without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed; provided that AMAG shall have the sole discretion to withhold consent in the event it determines that such settlement would restrict in any material respect the scope of the AMAG Patents or its rights or interests therein.

(e) Allocation of Proceeds . If either Party recovers monetary damages from any Third Party in a suit or action brought under Section 9.5(b), 9.5(c), or 9.8(b) with respect to AMAG Patents or Takeda Patents, including in a settlement, such recovery shall be allocated first to the reimbursement of any expenses incurred by the Parties in such litigation (including, for this purpose, a reasonable allocation of expenses of internal counsel), and any remaining amounts shall be split as follows: (i) the portion of such amounts that represents recovery for lost sales in the Licensed Territory shall be retained by Takeda and treated as Net Sales, on which Takeda shall make a royalty payment pursuant to Section 8.4 (without applying any reduction under Section 8.4(d) to such portion), and (ii) any remaining amounts shall be allocated [***].

9.6 Infringement of Third Party Rights in the Licensed Territory.

(a) Notice . If any Product used or sold by either Party, its Affiliates, licensees or sublicensees becomes the subject of a Third Party’s claim or assertion of infringement of a Patent granted by a jurisdiction within the Licensed Territory, the Party first having notice of the claim or assertion shall promptly notify the other Party, the Parties shall agree on and enter into an “identity of interest agreement” wherein such Parties agree to their shared, mutual interest in the outcome of such potential dispute, and thereafter, the Parties shall promptly meet to consider the claim or assertion and the appropriate course of action.

(b) Defense . Takeda shall have the first right, but not the obligation, to defend any such Third Party threatened or asserted claim of infringement of a Patent as described in Section 9.6(a) above, at Takeda’s expense. If Takeda does not commence actions to defend

such claim within thirty (30) days after it receives notice thereof (or within thirty (30) days after it should have given notice thereof to AMAG as required by Section 9.6(a)), then to the extent allowed by applicable Laws, AMAG shall have the right, but not the obligation, to control the defense of such claim by counsel of its choice, at AMAG’s expense. The non-defending Party shall reasonably cooperate with the Party conducting the defense of the claim or assertion, including, if required to conduct such defense, furnishing a power of attorney.

(c) Participation. Each Party shall have the right to participate or otherwise be involved in any such action controlled by the other Party, in each case at the participating Party’s sole cost and expense. If a Party elects to so participate or be involved, the controlling Party shall provide the participating Party and its counsel with an opportunity to consult with the controlling Party and its counsel regarding the prosecution of such action (including reviewing the contents of any correspondence, legal papers or other documents related thereto), and the controlling Party shall take into account reasonable requests of the participating Party regarding such enforcement or defense.

(d) Settlement; Licenses . Neither Party shall enter into any settlement of any claim described in this Section 9.6 that affects the other Party’s rights or interests or the scope of any AMAG Patent and/or Takeda Patent in any material respect without such other Party’s written consent. Each Party shall have the right to decline to defend or to tender defense of any such claim to the other Party upon reasonable notice, including if the other Party fails to agree to a settlement that such Party proposes. If a Party desires to take a license under any applicable Third Party intellectual property rights for the purpose of Developing or Commercializing the Product in the Field, then such Party shall submit the terms of such license to the JSC for review and approval. Any such license agreement will require the applicable Third Party to grant licenses to both Takeda and AMAG for performing their respective obligations and exercising their respective rights in the Licensed Territory under this Agreement, will contain a release of any liabilities accrued prior to the effective date of such license agreement, and will be subject to the mutual agreement of the Parties.

9.7 Patent Marking . Takeda (or its Affiliate or sublicensee) shall mark Product marketed and sold by Takeda (or its Affiliate or sublicensee) hereunder with appropriate patent numbers or indicia; provided, however, that Takeda shall only be required to so mark such Product to the extent such markings or such notices (i) would affect recoveries of damages or equitable remedies available under applicable Laws with respect to infringements of patents in the Licensed Territory and (ii) would not incur unreasonable cost considering the market, patent or other circumstances of the Product in such Licensed Territory, subject to consultation with AMAG.

9.8 Patent Oppositions and Other Proceedings.

(a) Third-Party Patent Rights . If either Party desires to bring an opposition, action for declaratory judgment, nullity action, interference, declaration for non-infringement, reexamination or other attack upon the validity, title or enforceability of a Patent owned or controlled by a Third Party and having one or more claims that covers the Product, or the use, sale, offer for sale or importation of the Product (except insofar as such action is a counterclaim

to or defense of, or accompanies a defense of, a Third Party’s claim or assertion of infringement under Section 9.6, in which case the provisions of Section 9.6 shall govern), such Party shall so notify the other Party and the Parties shall promptly confer to determine whether to bring such action or the manner in which to settle such action. Takeda shall have the exclusive right, but not the obligation, to bring at its own expense and in its sole control any such action in the Licensed Territory. If Takeda does not bring such an action in the Licensed Territory, within ninety (90) days of notification thereof pursuant to this Section 9.8(a) (or earlier, if required by the nature of the proceeding), then AMAG shall have the right, but not the obligation, to bring, at AMAG’s sole expense, such action. The Party not bringing an action under this Section 9.8(a) shall be entitled to separate representation in such proceeding by counsel of its own choice and at its own expense, and shall cooperate fully with the Party bringing such action. Any awards or amounts received in bringing any such action shall be retained by the Party initiating such action.

(b) Parties’ Patent Rights . If any AMAG Patent or Takeda Patent or Patent Term Extension related thereto becomes the subject of any proceeding commenced by a Third Party within the Licensed Territory in connection with an opposition, reexamination request, action for declaratory judgment, nullity action, interference or other attack upon the validity, title or enforceability thereof (except insofar as such action is a counterclaim to or defense of, or accompanies a defense of, an action for infringement against a Third Party under Section 9.5, in which case the provisions of Section 9.5 shall govern), then the Party responsible for filing, preparing, prosecuting and maintaining such Patent or Patent Term Extension as set forth in Sections 9.3 or 9.4 hereof shall control such defense at its own cost and expense. The controlling Party shall permit the non-controlling Party to participate in the proceeding to the extent permissible under applicable Laws, and to be represented by its own counsel in such proceeding, at the non-controlling Party’s expense. If either Party decides that it does not wish to defend against such action, then the other Party shall have the right to assume defense of such Third-Party action at its own expense. Any awards or amounts received in defending any such Third-Party action shall be allocated between the Parties as provided in Section 9.5(e).

(c) Compendial Listing and Register of Exclusive License . Upon request of Takeda, AMAG shall cooperate with Takeda to (i) file appropriate information with the applicable Regulatory Authority listing any AMAG Patents in the patent listing source in such country in the Licensed Territory that is equivalent or similar to the Orange Book in the U.S., if any, and (ii) register Takeda’s license granted hereunder to the applicable Regulatory Authority, a patent and trademark office or other relevant governmental agency or offices in the Licensed Territory, if any.

ARTICLE 10

REPRESENTATIONS AND WARRANTIES; COVENANTS

10.1 Mutual Representations and Warranties . Each Party hereby represents and warrants to the other Party as follows:

(a) Corporate Existence . As of the Effective Date, it is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated.

(b) Corporate Power, Authority and Binding Agreement . As of the Effective Date, (i) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (iii) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms.

10.2 Additional Representations and Warranties of AMAG . AMAG represents and warrants to Takeda as follows:

(a) Non-Infringement of AMAG Technology by Third Parties . As of the Effective Date, to AMAG’s Best Knowledge, there are no ongoing activities by Third Parties that would constitute infringement or misappropriation of the AMAG Technology within the Licensed Territory;

(b) Right to Grant Licenses. As of the Effective Date, AMAG has the full legal right, power and authority to grant the license rights set forth in Article 2;

(c) Ownership of AMAG Technology . As of the Effective Date, AMAG is the sole and exclusive owner of the AMAG Technology, all of which is free and clear of any liens, charges and encumbrances, and, to AMAG’s Best Knowledge, no other Person has any claim of ownership whatsoever with respect to the AMAG Technology or the Product;

(d) AMAG Patents Not Invalid or Unenforceable . As of the Effective Date, the AMAG Patents listed on Exhibit C-1 exist, and the issued patents in the AMAG Patents have not been held invalid or unenforceable, in whole or in part, by a court or other governmental agency of competent jurisdiction;

(e) Manufacturing Process Patent . As of the Effective Date, Product is produced materially in accordance with [***], would infringe the intellectual property rights of any Third Party.

(f) Legal Actions . As of the Effective Date, (i) there are no pending, or, to AMAG’s Best Knowledge, threatened legal actions, nor has AMAG received any written notice regarding any pending or threatened legal actions, with respect to the AMAG Technology or the Product; and (ii) except as disclosed to Takeda in writing prior to the Effective Date, AMAG has

not received written notice regarding any other pending legal action which would reasonably be expected to have a material adverse effect on the operations of AMAG as a whole.

(g) Patent Litigation . As of the Effective Date, AMAG has not received written notice of any pending or threatened claims or litigation seeking to invalidate any AMAG Patents or claiming that the practice of the AMAG Technology infringes the intellectual property rights of any Third Party;

(h) Third Party Agreements . As of the Effective Date, AMAG has not breached in any material respect, any agreements with Third Parties to which AMAG is a party existing as of the Effective Date relating to the Product ;

(i) Sufficiency of Licenses . As of the Effective Date, to AMAG’s Best Knowledge, AMAG Technology and the licenses granted by AMAG under Article 2 are sufficient for Takeda to Develop, seek Regulatory Approvals, Commercialize and Finish the Product in the Field in the Licensed Territory as contemplated by this Agreement;

(j) Provision of Information . AMAG has made available to Takeda the AMAG Patents and, to AMAG’s Best Knowledge, all written information in AMAG’s possession or Control as of the Effective Date requested by Takeda in writing relating to the Development or Commercialization of the Products in the Field in the Licensed Territory as contemplated by this Agreement;

(k) Safety Data . As of the Effective Date, AMAG has provided Takeda with the opportunity to review (i) any and all non-clinical safety data regarding the Product that is in AMAG’s possession or Control and (ii) any and all human subject safety data (life-threatening adverse drug experience, Serious Adverse Drug Experience, Unexpected Adverse Drug Experience, Adverse Event, Serious Adverse Event, Adverse Drug Reaction, Serious Adverse Drug Reaction, Unexpected Adverse Drug Reaction, as each is defined in 21 CFR 312 and/or ICH Guidance (ICH-E6)) regarding the Product that is in AMAG’s possession or Control;

(l) Conduct of Activities . As of the Effective Date, to AMAG’s Best Knowledge, each of AMAG, its contractors and its consultants has conducted all Development of Product and all Manufacturing of Product prior to the Effective Date in accordance with: (i) all material provisions of applicable Laws; (ii) the known or published standards of the FDA or other applicable Regulatory Authorities in the Licensed Territory; (iii) the prevailing scientific standards applicable to the conduct of such studies and activities in the Licensed Territory; and (iv) applicable regulatory materials, where the failure to do so would have a material adverse effect on the Development, Manufacturing and/or Commercialization of the Products in the Field for the Licensed Territory as contemplated by this Agreement;

(m) Audit of Contractors . Prior to the Effective Date, AMAG has conducted audits and/or assessments of its contract manufacturer organizations and contract research organizations, which organizations are or have been involved in activities with respect to the Product in accordance with the prevailing pharmaceutical industry standards and, as of the Effective Date, to AMAG’s Best Knowledge, there are no circumstances with respect to such

organizations that could reasonably be expected to have a material adverse effect on the Development, Manufacturing and/or Commercialization of the Product in the Field for the Licensed Territory as contemplated by this Agreement;

(n) Regulatory Authority Communications . As of the Effective Date, to AMAG’s Best Knowledge, neither AMAG nor any officer, employee or agent of AMAG has knowingly made an untrue statement of a material fact to any Regulatory Authority in or outside the Licensed Territory with respect to the Product or knowingly failed to disclose a material fact required to be disclosed to any Regulatory Authority in or outside the Licensed Territory with respect to the Product; and

(o) Government Funding . As of the Effective Date, none of the United States Government, any agency of the United States Government, any foreign government, or any agency of a foreign government has provided funding or support for any work performed in the conception or reduction to practice of any AMAG Patents.

10.3 Covenants .

(a) No Debarment . In the course of the Development of the Product, each Party shall not use, during the Term, any employee or consultant who has been debarred by any Regulatory Authority, or, to such Party’s Best Knowledge, is the subject of debarment proceedings by a Regulatory Authority. Each Party shall notify the other Party promptly upon becoming aware of any employee or consultant who has been debarred or is the subject of debarment proceedings by any Regulatory Authority.

(b) Compliance . Each Party and its Affiliates shall, to the extent applicable to its performance hereunder, comply in all material respects with all applicable Laws in the Development, Manufacture and Commercialization of the Product for the Licensed Territory and performance of its obligations under this Agreement, including the statutes, regulations and written directives of the FDA, the EMA and any Regulatory Authority having jurisdiction in the Licensed Territory, the FD&C Act, the Prescription Drug Marketing Act, the Federal Health Care Programs Anti-Kickback Law, 42 U.S.C. 1320a-7b(b), the statutes, regulations and written directives of Medicare, Medicaid and all other health care programs, as defined in 42 U.S.C. § 1320a-7b(f), and the Foreign Corrupt Practices Act of 1977, each as may be amended from time to time.

10.4 Disclaimer . Takeda understands that the Product is the subject of ongoing clinical research and development and that AMAG cannot assure the safety or usefulness of the Product. In addition, AMAG makes no warranties except as set forth in this Article 10 concerning the AMAG Technology.

10.5 No Other Representations or Warranties . EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL

PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY, AND ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.

ARTICLE 11

INDEMNIFICATION

11.1 Indemnification by AMAG . AMAG shall defend, indemnify, and hold Takeda and its Affiliates and their respective officers, directors, employees, and agents (the “Takeda Indemnitees” ) harmless from and against any and all Third Party claims, suits, proceedings, damages, expenses (including court costs and reasonable attorneys’ fees and expenses), and recoveries (collectively, “Claims” ) to the extent that such Claims arise out of, are based on, or result from (a) the Development, storage, handling, Manufacture (unless and to the extent liability for Manufacturing activities are covered by separate indemnification pursuant to the Supply Agreement, which in such event will control), distribution, use, promotion, sale, offer for sale, and importation of Product by or on behalf of AMAG or its Affiliates or its or their distributors (other than Takeda), licensees (other than Takeda), contract research organizations, contract manufacturers or other Third Party service providers (the “AMAG Group” ), or (b) the breach of any obligation, representation, warranty or covenant of AMAG in this Agreement, or (c) the willful misconduct or negligent acts of AMAG, its Affiliates, or the officers, directors, employees, or agents of AMAG or its Affiliates. The foregoing indemnity obligation shall not apply to the extent that (i) the Takeda Indemnitees fail to comply with the indemnification procedures set forth in Section 11.3 and AMAG’s defense of the relevant Claims is materially prejudiced by such failure, or (ii) any Claim arises from, is based on, or results from any activity for which Takeda is obligated to indemnify the AMAG Indemnitees under Section 11.2.

11.2 Indemnification by Takeda . Takeda shall defend, indemnify, and hold AMAG and its Affiliates and their respective officers, directors, employees, and agents (the “ AMAG Indemnitees ”) harmless from and against any and all Claims to the extent that such Claims arise out of, are based on, or result from (a) the Development, storage, handling, Manufacture (unless and to the extent liability for Manufacturing activities are covered by separate indemnification pursuant to the Supply Agreement or the agreed upon terms and conditions, if any, governing Takeda’s purchase of clinical supplies of the Product prior to the Parties’ execution of the Supply Agreement, which in such event will control), distribution, use, promotion, sale, offer for sale, and importation of Product by or on behalf of Takeda or its Affiliates or its or their sublicensees, distributors, contract research organizations, contract manufacturers or other Third Party service providers, or (b) the breach of any obligation, representation, warranty or covenant of Takeda in this Agreement, or (c) the willful misconduct or negligent acts of Takeda, its Affiliates, or the officers, directors, employees, or agents of Takeda or its Affiliates. The foregoing indemnity obligation shall not apply to the extent that (i) the AMAG Indemnitees fail to comply with the indemnification procedures set forth in Section 11.3 and Takeda’s defense of the relevant Claims is materially prejudiced by such failure, or (ii) any Claim arises from, is based on, or results from any activity for which AMAG is obligated to indemnify the Takeda Indemnitees under Section 11.1.

11.3 Indemnification Procedures . The Party claiming indemnity under this Article 11 (the “ Indemnified Party ”) shall give written notice to the Party from whom indemnity is being sought (the “ Indemnifying Party ”) in a reasonably timely manner after learning of such Claim. The Indemnified Party shall provide the Indemnifying Party with reasonable assistance, at the Indemnifying Party’s expense, in connection with the defense of the Claim for which indemnity is being sought. The Indemnified Party may participate in and monitor such defense with counsel of its own choosing at its sole expense; provided, however, the Indemnifying Party shall have the right to assume and conduct the defense of the Claim with counsel of its choice. The Indemnifying Party shall not settle any Claim without the prior written consent of the Indemnified Party, not to be unreasonably withheld or delayed, unless the settlement involves only the payment of money. The Indemnified Party shall not settle any such Claim without the prior written consent of the Indemnifying Party. If the Indemnifying Party does not assume and conduct the defense of the Claim as provided above, (a) the Indemnified Party may defend against, and consent to the entry of any judgment or enter into any settlement with respect to, the Claim in any manner the Indemnified Party may deem reasonably appropriate (and the Indemnified Party need not consult with, or obtain any consent from, the Indemnifying Party in connection therewith), and (b) the Indemnifying Party will remain responsible to indemnify the Indemnified Party as provided in this Article 11.

11.4 Limitation of Liability . NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 11.4 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 11.1 OR 11.2, OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS IN ARTICLE 12.

11.5 Insurance . Each Party shall procure and maintain insurance or self-insurance, including human clinical trial liability insurance and product liability insurance, adequate to cover its obligations hereunder and consistent with local statutory requirements and customary business practices of prudent companies similarly situated at all times during which any Product is being clinically tested in human subjects or commercially distributed or sold by such Party. Each Party shall maintain such product liability insurance or self-insurance for a period of [***] after the Term of this Agreement. It is understood that such insurance shall not be construed to create a limit of either Party’s liability with respect to its indemnification obligations under this Article 11. Each Party shall provide the other Party with written evidence of such insurance upon request. Each Party shall provide the other Party with written notice within thirty (30) days

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

after the cancellation, non-renewal or material change in such insurance or self-insurance which materially adversely affects the rights of the other Party hereunder.

ARTICLE 12

CONFIDENTIALITY

12.1 Confidentiality . Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties during a period that is the longer of (i) [***], each Party agrees that it shall keep confidential and shall not publish or otherwise disclose and shall not use for any purpose other than as provided for in this Agreement any Confidential Information furnished to it by the other Party pursuant to this Agreement or the Mutual Confidentiality Agreement between the Parties dated May 19, 2009, except for that portion of such information or materials that the receiving Party can demonstrate by competent written proof:

(a) was already known to the receiving Party or its Affiliate, other than under an obligation of confidentiality, at the time of disclosure by the other Party;

(b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;

(c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement;

(d) was disclosed to the receiving Party or its Affiliate by a Third Party who has a legal right to make such disclosure; or

(e) was independently discovered or developed by or on behalf of the receiving Party or its Affiliate without the aid, application, or use of the disclosing Party’s Confidential Information, as evidenced by a contemporaneous writing.

12.2 Authorized Disclosure . Each Party may disclose Confidential Information belonging to the other Party to the extent such disclosure is reasonably necessary in the following situations:

(a) regulatory filings and other filings with Governmental Authorities, including filings with the Securities and Exchange Commission or other relevant exchange on which such Party is listed;

(b) prosecuting or defending litigation;

(c) complying with applicable Laws;

(d) disclosure to its employees, agents, consultants, and any bona fide Third Party potential (sub)-licensees (including potential Third Party partners) only on a need-to-know basis and solely as necessary in connection with the performance of or as otherwise contemplated by this Agreement, provided that in each case the recipient of such Confidential Information must agree to be bound by similar obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Article 12 prior to any such disclosure; and

(e) disclosure of the material terms of this Agreement to any bona fide potential investor, investment banker, acquiror, merger partner, licensees, sublicensees or other potential or actual financial or commercial partner; provided that in connection with such disclosure, the disclosing Party shall use all reasonable efforts to inform each recipient of the confidential nature of such Confidential Information and cause each recipient of such Confidential Information to treat such Confidential Information as confidential.

Notwithstanding the foregoing, in the event a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to clause (a) through (c) of this Section 12.2, it will, except where impracticable, give reasonable advance notice to the other Party of such disclosure and use diligent efforts to secure confidential treatment of such information. In any event, the Parties agree to take all reasonable action to avoid disclosure of Confidential Information hereunder. Each Party will be responsible for any acts or omissions of any Third Party to which such Party discloses Confidential Information in accordance with this Section 12.2.

12.3 Publicity .

(a) The Parties shall make a joint public announcement of the execution of this Agreement in the form attached as Exhibit E , which shall be issued at a time to be mutually agreed by the Parties.

(b) After release of such press release, if either Party desires to make a public announcement concerning the material terms of this Agreement, such Party shall give reasonable prior advance notice of the proposed text of such announcement to the other Party for its prior review and approval (except as otherwise provided herein), such approval not to be unreasonably withheld. A Party commenting on such a proposed press release shall use Commercially Reasonable Efforts to provide its comments, if any, within three (3) business days after receiving the press release for review. In addition, where required by law or by the regulations of the applicable securities exchange upon which a Party may be listed, such Party shall have the right to make a press release announcing the achievement of each milestone under this Agreement as it is achieved, and the achievements of Regulatory Approvals in the Licensed Territory as they occur, subject only to the review procedure set forth in the preceding sentence. In relation to the other Party’s review of such an announcement, such other Party may make specific, reasonable comments on such proposed press release within the prescribed time for commentary, but shall not withhold its consent to disclosure of the information that the relevant milestone has been achieved and triggered a payment hereunder. Neither Party shall be required to seek the permission of the other Party to repeat any information regarding the terms of this Agreement

that has already been publicly disclosed by such Party, or by the other Party, in accordance with this Section 12.3.

ARTICLE 13

TERM AND TERMINATION

13.1 Term . This Agreement shall become effective on the Effective Date and, unless earlier terminated pursuant to this Article 13, shall remain in effect on a Product-by-Product and on a country-by-country basis until the cessation of all commercial sales of the Product in the Licensed Territory.

13.2 Unilateral Termination by Takeda.

(a) Termination Notice . Takeda may terminate this Agreement in its entirety, following: (i) [***] consultation with AMAG followed by [***] prior written notice, if such termination is effective prior to the First Commercial Sale of the Product anywhere in the Licensed Territory, or (ii) [***] consultation with AMAG followed by [***] prior written notice if such termination is effective after the First Commercial Sale of the Product anywhere in the Licensed Territory. Notwithstanding the foregoing, Takeda may terminate this Agreement in its entirety, following [***] consultation with AMAG followed by [***] prior written notice, if Takeda has determined in good faith that the continued Development or Commercialization of the Product would not be in the best interest of patient welfare. In addition, Takeda may terminate this Agreement on a country-by-country basis at any time after expiration of the Royalty Term in a country by giving [***] prior written notice.

(b) Effect of Unilateral Termination . If Takeda terminates this Agreement in its entirety pursuant to Section 13.2(a), then:

(i) Takeda shall not, during such applicable notice period, take any action that could reasonably be expected to have a material adverse impact on the further Development and Commercialization of the Product in or outside the Licensed Territory; provided, however, that Takeda shall have the right to take any actions it deems reasonably necessary or appropriate to avoid any human health or safety problems;

(ii) Takeda shall be required to perform (and bear all costs and expenses of) any outstanding obligations of Takeda that accrued prior to the effective date of termination, but Takeda shall be released from any other obligations after the effective date of termination, unless otherwise specifically set forth in this Section 13.2;

(iii) Takeda shall be responsible for any reasonable and non-cancelable costs incurred by AMAG prior to the effective date of termination in connection with its supply of Product to Takeda under this Agreement or the Supply Agreement, provided, however, that upon receipt of notice from Takeda, AMAG shall use Commercially Reasonable Efforts to minimize such non-cancelable costs; and

(iv) the JSC shall coordinate the wind-down of Takeda’s efforts under this Agreement, and the provisions of Section 13.6 shall apply.

13.3 Termination for Breach . AMAG shall have the right to terminate this Agreement upon written notice to Takeda for material breach by Takeda of its obligations under this Agreement if, after receiving written notice identifying such material breach, Takeda fails to cure such material breach within [***] from the date of such notice (or within [***] in the event such breach is solely based upon Takeda’s failure to pay any undisputed amounts due AMAG hereunder); provided, however, that AMAG shall not have the right to terminate this Agreement for Takeda’s breach of its obligations under Section 4.7 to use Commercially Reasonable Efforts to conduct any Development activities that Takeda assumes pursuant to Section 4.4(a)(ii), 4.4(b)(ii), 4.4(b)(iii) or 4.4(c)(iii). Takeda shall have the right to terminate this Agreement upon written notice to AMAG for material breach by AMAG of its obligations under this Agreement if, after receiving written notice identifying such material breach, AMAG fails to cure such breach within [***] from the date of such notice (or within [***] in the event such breach is solely based upon AMAG’s failure to pay any undisputed amounts due Takeda hereunder). If a material breach affects and relates only to one or more of [***], then such termination right (a) shall be only with respect to the Region(s) affected by such material breach or to which such material breach relates, [***], and (b) shall be subject to any other express provisions of this Agreement providing for notice and cure of a Party’s alleged breach hereunder. No payment or agreement to pay under this Agreement (including those referred to as nonrefundable or non-creditable) shall in any way preclude or limit the rights of either Party to seek the full recovery of its damages or to seek equitable relief for breach of this Agreement by the other Party.

13.4 Termination for Patent Challenge . AMAG shall have the right to terminate this Agreement upon written notice to Takeda, effective upon receipt, if (a) Takeda or any of its Affiliates, directly or indirectly: (i) initiates or requests an interference, opposition proceeding or request for ex parte or inter parties reexamination with respect to any AMAG Patent, or (ii) makes, files or maintains any claim, demand, lawsuit or cause of action to challenge the validity or enforceability of any an AMAG Patent (each, a “ Patent Challenge ”), or (b) a sublicensee of Takeda (or an Affiliate of such sublicensee) undertakes a Patent Challenge and Takeda fails to terminate the applicable sublicenses in accordance with Section 2.1(c), provided that for any such proceeding that can be terminated by Takeda after initiation, AMAG provides Takeda with

a notice of termination at least [***] prior to such termination and Takeda does not within such [***] period withdraw and terminate such Patent Challenge. If Takeda or its Affiliates or sublicensees withdraw such Patent Challenge and such proceeding is terminated within such [***] period, then AMAG shall have no right to terminate under this Section 13.4.

13.5 Termination for Bankruptcy . A Party may terminate this Agreement in its entirety upon written notice to the other Party upon or after the time that such other Party makes a general assignment for the benefit of creditors, files an insolvency petition in bankruptcy, petitions for or acquiesces in the appointment of any receiver, trustee or similar officer to liquidate or conserve its business or any substantial part of its assets, 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 or becomes a party to any proceeding or action of the type described above and such proceeding or action remains un-dismissed or un-stayed for a period of more than [***].

13.6 AMAG Rights upon Termination of the Agreement . Upon the early termination of this Agreement by Takeda under Section 13.2(a), by either Party under Section 13.3 due to the other Party’s material uncured breach, or by AMAG under Section 13.4 for Patent Challenge, the following shall apply (in addition to any other rights and obligations under Section 13.2, 13.3 or 13.4 or otherwise under this Agreement with respect to such termination). For the avoidance of doubt, in case of termination for a particular Region(s), the following provisions shall apply solely for such Region(s):

(a) Regulatory Materials; Data; Trademarks . To the extent permitted by applicable Laws, Takeda shall transfer and assign to AMAG all Regulatory Materials, Regulatory Approvals, and related data relating to the Product existing as of the date of such termination throughout the Licensed Territory as and to the extent owned or Controlled by Takeda, and shall assign to AMAG all of its right, title and interest in the New Product Marks.

(b) Takeda License . Takeda hereby grants to AMAG, effective only in event of such termination, an exclusive, irrevocable, transferable, royalty-free license, with the right to grant multiple tiers of sublicenses, under the Takeda Technology existing and actually used and applied as of the date of such termination to Develop, make, have made, use, sell, offer for sale, have sold, import and otherwise Commercialize the Product in the Licensed Territory, which license shall be effective as of the date of such termination.

(c) Transition Assistance . For one (1) year following the effective date of such termination, Takeda shall provide such assistance, [***] as may be reasonably necessary or useful for AMAG to commence or continue Developing, Manufacturing or Commercializing Product in the Licensed Territory, to the extent Takeda is then performing or having performed

such activities, including transferring or amending as appropriate, upon request of AMAG, any agreements or arrangements with Third Party vendors to Develop, Manufacture, distribute or sell Product in the terminated Regions of the Licensed Territory. To the extent that any such contract between Takeda and a Third Party is not assignable to AMAG, then Takeda shall reasonably cooperate with AMAG to arrange to continue to provide such services from such entity for so long as may be reasonably necessary to transition such services, provided, however, this cooperation shall not be construed as an obligation and/or promise of Takeda to ensure that any new arrangement between AMAG and a Third Party vendor is established. In addition, upon any termination of this Agreement under Section 13.2(a), Takeda shall pay its share (if any) of costs for (i) the completion of any ongoing clinical trial of the Product to the extent such costs are incurred for those patients already enrolled in the trial at the time of giving the termination notice and (ii) uncancellable obligations incurred to Third Parties as a direct result of cancellation of such trial.

13.7 Rights in Bankruptcy . All rights and licenses granted under or pursuant to this Agreement by AMAG are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code. The Parties agree that Takeda, as the licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the U.S. Bankruptcy Code. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against AMAG under the U.S. Bankruptcy Code, Takeda shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, which, if not already in Takeda’s possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon Takeda’s written request therefor, unless AMAG elects to continue to perform all of its obligations under this Agreement or (b) if not delivered under clause (a), following the rejection of this Agreement by AMAG upon written request therefor by Takeda.

13.8 Survival . The following provisions shall survive any expiration or termination of this Agreement for the period of time specified: Sections 2.2(b), 2.6, 5.1(b), 8.9, 9.1, 9.2, 10.5, 13.2(b), 13.6, 13.8, 14.3, 14.4, 14.5, 14.6 and 14.7 and Articles 11, 12, 15 and 16. For clarity and notwithstanding anything to the contrary in the Agreement, termination of this Agreement shall be in addition to, and shall not prejudice, the Parties’ remedies at law or in equity, including the Parties’ ability to receive legal damages and/or equitable relief with regard to any breach of this Agreement, regardless of whether or not such breach was the reason for the termination.

ARTICLE 14

DISPUTE RESOLUTION

14.1 Disputes . The Parties recognize that disputes as to certain matters may from time to time arise during the Term which relate to either Party’s rights and/or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in

this Article 14 to resolve any controversy or claim arising out of, relating to or in connection with any provision of this Agreement, if and when a dispute arises under this Agreement.

14.2 Referred from JSC .

(a) General . With respect to disputes arising from matters delegated to the JSC pursuant to the terms of Article 3, either Party may, by written notice to the other Party, have such dispute referred to each Party’s Designated Executive for attempted resolution by good faith negotiations within thirty (30) days after such notice is received. If the Designated Executives are not able to resolve such dispute within such thirty (30) day period, then if such dispute does not relate to a matter described in Section 14.2(b), either Party may at any time thereafter pursue any legal or equitable remedy available to it in accordance with this Article 14.

(b) Specific Decision-Making Rights . If the Designated Executives of the Parties are not able to resolve a dispute within the thirty (30) day period described above, and the matter is related to one of the areas listed below as delegated to the JSC, then AMAG or Takeda, as the case may be, shall have the unilateral right to cast the deciding vote for the JSC as provided below. Except as otherwise provided in subsections (i) or (ii) below, neither Party (including its JDC and JSC members and Designated Executive) shall have the right to change the Development Plan with respect to the Initial Studies, including their scope and time schedules, without the other Party’s prior written consent, not to be unreasonably withheld.

(i) AMAG Decisions . The Designated Executive of AMAG shall have the right to make the final decision with respect to the following: [***] and (4) the Commercialization of the Product outside the Licensed Territory. Notwithstanding the foregoing, the Designated Executive of AMAG shall not make any decision (without obtaining the prior written consent of Takeda not to be unreasonably withheld) that [***]. In addition, nothing in this Section 14.2(b) shall (X) be construed to limit AMAG’s ability to carry out day-to-day decisions related to its Development activities as set forth in the Development Plan, or (Y) limit AMAG’s compliance with applicable Laws, reporting requirements to Regulatory Authorities or its internal policies or decisions regarding matters affecting the health, safety or welfare of a patient.

(ii) Takeda Decisions . The Designated Executive of Takeda shall have the right to make the final decision with respect to any matters not listed in subsection (i) above, including matters involving: [***]. Notwithstanding the foregoing, the Designated Executive of Takeda shall not make any decision (without obtaining the prior written consent of AMAG not to be unreasonably withheld) that [***]. In addition, nothing in this Section 14.2(b) shall limit Takeda’s compliance with applicable Laws, reporting requirements to Regulatory Authorities or its internal policies or decisions regarding matters affecting the health, safety or welfare of a patient.

14.3 Arising Between the Parties . Except as provided in Section 14.2, with respect to all other disputes arising between the Parties and not from the JSC, including any alleged failure to perform or breach of this Agreement, or any issue relating to the interpretation or application of this Agreement, if the Parties are unable to resolve such dispute within thirty (30) days after such dispute is first identified by either Party in writing to the other, the Parties shall refer such dispute to the Designated Executive for each Party for attempted resolution by good faith negotiations within thirty (30) days after such notice is received. If any such dispute is not resolved by such Designated Executives within such period, either Party may at any time thereafter invoke the provisions of Section 14.4.

14.4 ADR.

(a) Any dispute, controversy or claim arising out of or relating to the validity, construction, interpretation, enforceability, breach, performance, application or termination of this Agreement that is not resolved pursuant to Section 14.3, except for matters subject to Section 14.2 or a dispute, claim or controversy under Section 14.5, shall be resolved by the Alternative Dispute Resolution (“ ADR ”) provisions set forth in Exhibit F attached hereto, the result of which shall be binding upon the Parties. The Parties shall have the right to be represented by counsel in such a proceeding.

(b) Survivability. Any duty to engage in ADR under this Agreement shall remain in effect and be enforceable after termination of this Agreement for any reason.

14.5 Patent and Trademark Disputes. Any dispute, controversy or claim relating to the scope, validity, enforceability or infringement of any Patents or trademarks covering the manufacture, use, importation, offer for sale or sale of Products shall be submitted to a court of competent jurisdiction in the country in which such patent or trademark rights were granted or arose.

14.6 Injunctive Relief . Nothing herein may prevent either Party from seeking a preliminary injunction or temporary restraining order or other equitable remedy if necessary to protect the interests of such Party or to preserve the status quo pending the arbitration proceeding, including preservation of Confidential Information .

14.7 WAIVER OF RIGHT TO JURY TRIAL . In connection with the Parties’ rights under Sections 14.5 and 14.6, EACH PARTY, TO THE EXTENT PERMITTED BY LAW, KNOWINGLY, VOLUNTARILY, AND INTENTIONALLY WAIVES ITS RIGHT TO A TRIAL BY JURY IN ANY ACTION OR OTHER LEGAL PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT AND THE TRANSACTIONS IT CONTEMPLATES. THIS WAIVER APPLIES TO ANY ACTION OR LEGAL PROCEEDING, WHETHER SOUNDING IN CONTRACT, TORT, OR OTHERWISE.

ARTICLE 15

STANDSTILL

15.1 Standstill Agreement . During the [***] (the “ Standstill Period ”), none of Takeda, Takeda’s Affiliates, nor any of their respective directors, officers, employees, agents or representatives (provided such person is acting on behalf of Takeda or is in possession of Confidential Information of AMAG) will, in any manner, directly or indirectly, without the prior express written consent of AMAG:

(a) acquire, offer to acquire or agree to acquire, alone or in concert with any other Person, by purchase, tender offer, exchange offer, agreement or business combination or any other manner: (i) more than [***] of the beneficial ownership of any securities of AMAG or any securities of any Affiliate of AMAG; or (ii) any assets of AMAG or any assets of any Affiliate of AMAG other than non-material acquisitions in the ordinary course of business;

(b) initiate, participate in or enter into any merger, business combination, recapitalization, restructuring, liquidation, dissolution or other extraordinary transaction involving AMAG or any Affiliate of AMAG, or involving any securities or assets of AMAG or any securities or assets of any Affiliate of AMAG;

(c) “solicit” “proxies” (as those terms are used in the proxy rules of the Securities and Exchange Commission) or consents with respect to any securities of AMAG;

(d) form, join or participate in a Group with respect to the beneficial ownership of any securities of AMAG;

(e) act, alone or in concert with others, to seek to control or influence the management, board of directors or policies of AMAG;

(f) take any action that would reasonably be expected to require AMAG to make a public announcement regarding any of the types of matters set forth in clause (a), (b), (c) or (d) of this Section 15.1;

(g) agree, offer to take, propose, assist, induce or encourage any other Person to take, publicly or otherwise, any action of the type referred to in clause (a), (b), (c), (d), (e) or (f) of this Section 15.1;

(h) enter into any discussions, negotiations, arrangements or agreements with any other Person relating to any of the foregoing; or

(i) request or propose that AMAG or any of AMAG’s representatives amend, waive or consider the amendment or waiver of any of the provisions set forth in this Section 15.1.

15.2 Exceptions to Standstill.

(a) Notwithstanding the foregoing restrictions, the provisions of Section 15.1 shall not apply to:

(i) the exercise by Takeda of any of its rights under this Agreement;

(ii) the exercise by Takeda as an AMAG stockholder, if applicable, of any voting rights available to AMAG stockholders generally pursuant to any transaction described Section 15.1(a)(ii) or (b) above, provided that Takeda has not then either directly, indirectly, or as a member of a Group made, effected, initiated or caused such transaction to occur;

(iii) any activity by Takeda after AMAG has made any public announcement of its intent to solicit or engage in any transaction which would result in a Change of Control of AMAG, or after any such Change of Control of AMAG shall have occurred;

(iv) making any communication to AMAG executive management on a confidential basis that Takeda would be interested in engaging in discussions with AMAG that could result in a negotiated transaction described in Section 15.1(a) or (b) so long as Takeda does not propose any such transaction without AMAG’s prior consent.

(v) any investment by Takeda or an Affiliate of Takeda in third-party mutual funds or other similar passive investment vehicles that hold interests in securities of AMAG or any of its Affiliates (and any such interests in securities shall not be taken into account for the purpose of Section 15.1(a)), provided that the provisions of this clause (v) shall apply with respect to any such fund or vehicle only for so long as such fund or vehicle satisfies the requirements of paragraphs (i) and (ii) of Rule 13d-1(b)(1) promulgated under the Securities Exchange Act of 1934, as amended, with respect to any AMAG securities held by such fund or vehicle; or

(vi) Takeda’s engagement and/or discussions with legal, accounting, or financial advisors for the limited purposes of evaluating any of the transactions contemplated in subparagraphs (a), (b), (c), (d), (e) or (f) of Section 15.1.

(b) Except as provided in Section 15.3 below, the restrictions of Section 15.1 no longer shall be applicable in the event of the occurrence of any of the following:

(i) AMAG enters into a definitive written merger, sale or other business combination agreement pursuant to which fifty percent (50%) or more of the outstanding common stock of AMAG would be converted into cash or securities of another Person or Group or, immediately after the consummation of such transaction, fifty percent (50%) or more of the then outstanding common stock of AMAG would be owned by Persons other than the holders of common stock of AMAG immediately prior to the consummation of such transaction, or which would result in all or substantially all of AMAG’s assets being sold to any Person or Group;

(ii) AMAG becomes the subject of any bankruptcy, insolvency or similar proceeding (except for an involuntary proceeding that is dismissed within sixty (60) days);

(iii) AMAG engages in the public solicitation of one (1) or more Third Party bids for any transaction which would result in a Change of Control of AMAG.

AMAG shall inform Takeda in writing within 48 hours after the occurrence of any of the foregoing events listed in this Section 15.2(b).

15.3 Reinstatement of Standstill . The provisions of Section 15.1 shall again be applicable if: (a) AMAG or such Third Party, Person or Group, as applicable, terminates or announces its intent not to proceed with any transaction referred to in Sections 15.2(a)(iii) and 15.2(b)(i) or (iii) above, as applicable, or, in the case of Section 15.2(b)(ii) above, AMAG shall cease to be the subject of any such bankruptcy, insolvency or similar proceeding, as applicable; and (b) either (1) Takeda has not made any public announcement of its intent to acquire AMAG, or (2) in the event such a public announcement has been made by Takeda, Takeda has terminated or announced its intent to terminate such transaction.

15.4 Most Favored Nations Treatment . If, during the Standstill Period, AMAG enters into any development and commercialization agreement with a Third Party that is similar in size and scope to this Agreement (the “Third Party Agreement” ), which does not contain provisions restricting the activities of such Third Party that, taken as a whole (the “Third Party Standstill Provisions” ), are at least as onerous to the Third Party as the provisions of Section 15.1, then, upon the effective date of the Third Party Agreement, the provisions of Section 15.1 shall automatically be deemed modified without further action so as to conform to the Third Party Standstill Provisions. For the avoidance of doubt, the Parties agree that if the Third Party Agreement contains no standstill provision, Article 15 shall terminate in its entirety upon the effective date of the Third Party Agreement.

The expiration of the Standstill Period will not terminate or otherwise affect any other provisions of this Agreement.

ARTICLE 16

MISCELLANEOUS

16.1 Entire Agreement; Amendment . This Agreement, including the Exhibits and Schedules hereto, sets forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto with respect to the subject matter hereof and supersedes, as of the Effective Date, all prior and contemporaneous agreements and understandings between the Parties with respect to the subject matter hereof; provided, that the Mutual Confidentiality Agreement between the Parties dated May 19, 2009 (the “ CDA ”) shall continue in full force and effect in accordance with its terms. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth

herein and in the CDA. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.

16.2 Force Majeure . Both Parties shall be excused from the performance of their obligations under this Agreement to the extent that such performance is prevented by force majeure and the nonperforming Party promptly provides notice of the prevention to the other Party. Such excuse shall be continued so long as the condition constituting force majeure continues and the nonperforming Party takes reasonable efforts to remove the condition. For purposes of this Agreement, force majeure shall include conditions beyond the control of the Parties, including an act of God, war, civil commotion, terrorist act, labor strike or lock-out, epidemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe, and failure of plant or machinery (provided that such failure could not have been prevented by the exercise of skill, diligence, and prudence that would be reasonably and ordinarily expected from a skilled and experienced person engaged in the same type of undertaking under the same or similar circumstances). If a force majeure persists for more than [***], then the Parties will discuss in good faith the modification of the Parties’ obligations under this Agreement in order to mitigate the delays caused by such force majeure.

16.3 Notices . Any notice required or permitted to be given under this Agreement shall be in writing, shall specifically refer to this Agreement, and shall be addressed to the appropriate Party at the address specified below or such other address as may be specified by such Party in writing in accordance with this Section 16.3, and shall be deemed to have been given for all purposes (a) when received, if hand-delivered or sent by a reputable courier service, or (b) five (5) business days after mailing, if mailed by first class certified or registered airmail, postage prepaid, return receipt requested.

If to AMAG:		AMAG Pharmaceuticals, Inc.
		100 Hayden Ave.
		Lexington, MA 02421
		USA
		Attn: General Counsel

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

If to Takeda:		Takeda Pharmaceutical Company Limited
		1-1, Doshomachi 4-chome, Chuo-ku, Osaka, 540-8645, Japan
		Attn: General Manager, Global Licensing and Business Development Department

With copies to:		Takeda Pharmaceutical Company Limited
		1-1, Doshomachi 4-chome, Chuo-ku, Osaka, 540-8645, Japan
		Attn: General Manager, Legal Department

		Takeda Pharmaceuticals International Inc.
		One Takeda Parkway
		Deerfield, IL 60015
		Attn: Vice President, Global Licensing and Business Development

		Takeda Pharmaceuticals North America, Inc.
		One Takeda Parkway
		Deerfield, IL 60015
		Attention: General Counsel

16.4 No Strict Construction; Headings . This Agreement has been prepared jointly by the Parties and shall not be strictly construed against either Party. Ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision. The headings of each Article and Section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular Article or Section. Except where the context otherwise requires, the use of any gender shall be applicable to all genders, and the word “or” is used in the inclusive sense (and/or). The term “including” as used herein means including, without limiting the generality of any description preceding such term.

16.5 Assignment . Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other, except that a Party may make such an assignment without the other Party’s consent to its Affiliates or to a Third Party successor to substantially all of the business of such Party in connection with a Change of Control of such Party (such Third Party, an “ Acquiror ”). Any successor or assignee of rights and/or obligations permitted hereunder shall, in writing to the other Party, expressly

assume performance of such rights and/or obligations. Any permitted assignment shall be binding on the successors of the assigning Party. Any assignment or attempted assignment by either Party in violation of the terms of this Section 16.5 shall be null, void and of no legal effect. A “ Change of Control ” of a Party shall occur if: (i) any Third Party acquires directly or indirectly the beneficial ownership of any voting security of such Party, or if the percentage ownership of such person or entity in the voting securities of such Party is increased through stock redemption, cancellation or other recapitalization, and immediately after such acquisition or increase such Third Party is, directly or indirectly, the beneficial owner of voting securities representing more than fifty percent (50%) of the total voting power of all of the then-outstanding voting securities of such Party; (ii) a merger, consolidation, recapitalization, or reorganization of such Party is consummated, other than any such transaction which would result in stockholders or equity holders of such Party or an Affiliate of such Party immediately prior to such transaction owning at least fifty percent (50%) of the outstanding securities of the surviving entity (or its parent entity) immediately following such transaction; or (iii) the stockholders or equity holders of such Party approve a plan of complete liquidation of such Party, or an agreement for the sale or disposition by such Party of all or a substantial portion of such Party’s assets, other than to an Affiliate.

16.6 Performance by Affiliates . Each Party may discharge any obligations and exercise any right hereunder through any of its Affiliates. Each Party hereby guarantees the performance by its Affiliates of such Party’s obligations under this Agreement, and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. Any breach by a Party’s Affiliate of any of such Party’s obligations under this Agreement shall be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first proceed against such Party’s Affiliate.

16.7 Further Actions . Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

16.8 Severability . If any one or more of the provisions of this Agreement is held to be invalid or unenforceable by any court of competent jurisdiction from which no appeal can be or is taken, the provision shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof. The Parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.

16.9 No Waiver . Any delay in enforcing a Party’s rights under this Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement, except with respect to an express written and signed waiver relating to a particular matter for a particular period of time.

16.10 Independent Contractors . Each Party shall act solely as an independent contractor, and nothing in this Agreement shall be construed to give either Party the power or authority to act for, bind, or commit the other Party in any way. Nothing herein shall be

construed to create the relationship of partners, principal and agent, or joint-venture partners between the Parties.

16.11 English Language; Governing Law . This Agreement was prepared in the English language, which language shall govern the interpretation of, and any dispute regarding, the terms of this Agreement. This Agreement and all disputes arising out of or related to this Agreement or any breach hereof shall be governed by and construed under the laws of the State of New York, United States of America, without giving effect to any choice of law principles that would require the application of the laws of a different state.

16.12 Counterparts . This Agreement may be executed in one (1) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

[Signature Page Follows]

IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate originals by their duly authorized officers as of the Effective Date.

TAKEDA PHARMACEUTICAL COMPANY LIMITED		AMAG PHARMACEUTICALS, INC.


By:	/s/ Yasuchika Hasegawa	By:	/s/ Brian J.G. Pereira, M.D.

Name:	Yasuchika Hasegawa	Name:	Brian J.G. Pereira, M.D.

Title:	President and Chief Executive Officer	Title:	President and Chief Executive Officer

Exhibits

Exhibit A	Product Description
Exhibit B	Licensed Territory
Exhibit C-1	AMAG Patents
Exhibit C-2	Takeda Patents
Exhibit D	AMAG House Marks and AMAG Product Marks
Exhibit E	Joint Press Release
Exhibit F	Dispute Resolution

Schedules

Schedule 4.4(a)	Initial Studies
Schedule 4.4(b)	U.S. Studies and Pediatric Studies
Schedule 5.1	Clinical Trials of the Product
Schedule 7.2	Supply Agreement Terms
Schedule 7.3	Second Source Plan

[***]

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

EXHIBIT A
PRODUCT DESCRIPTION

[***]

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

EXHIBIT B
LICENSED TERRITORY

Part I (Europe)

Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom, Norway, Iceland and Switzerland

Part II (Asia Pacific)

Australia, Brunei, Cambodia, Fiji, Indonesia, Kiribati, North Korea, South Korea, Laos, Malaysia, Marshall Islands, Federated States of Micronesia, Nauru, New Zealand, Palau, Papua New Guinea, Philippines, Samoa, Singapore, Solomon Islands, Thailand, Timor-Leste, Tonga, Tuvalu, Vanuatu, Vietnam, American Samoa, Guam and Northern Mariana Islands

Part III (CEE)

Albania, Croatia, Bosnia and Herzegovina, Serbia, Montenegro and Macedonia

Part IV (CIS)

Georgia, Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Ukraine and Uzbekistan

Party V

Canada, India and Turkey

EXHIBIT C-1
AMAG PATENTS

[***]

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

EXHIBIT C-2
TAKEDA PATENTS

None

EXHIBIT D
AMAG HOUSE MARKS AND AMAG PRODUCT MARKS

AMAG HOUSE MARKS

AMAG PHARMACEUTICALS and all formulations of this name, including any stylized representation of the letter “A”

AMAG PRODUCT MARKS

FERAHEME, PROHEMA, PROHEME, WELFEROX and ZENFEROX

MARK	COUNTRY	APPLICATION/ REGISTRATION NO.	HISTORY & CURRENT STATUS
FERAHEME	Canada	Application No. 1422447	Filed 12/19/08, Allowed 1/15/10
FERAHEME	European Union	Registration No. 7480916	Filed 12/19/08, Registered 6/9/09
FERAHEME	India	Application No. 1766038	Filed 12/19/08
FERAHEME	Switzerland	Registration No. 586630	Filed 12/19/08, Registered 5/15/09

EXHIBIT E
JOINT PRESS RELEASE

AMAG Pharmaceuticals and Takeda Pharmaceutical Company Announce Strategic Collaboration for Feraheme® in All Therapeutic Indications in Select Ex-US Territories, Including Europe

LEXINGTON, MA and Osaka, Japan (April 1, 2010) — AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) and Takeda Pharmaceutical Company Limited (TSE: 4502) today jointly announced that the companies have entered into a license, development and commercialization agreement related to Feraheme® (ferumoxytol) Injection for intravenous (IV) use in all therapeutic indications.

Agreement Highlights

· Takeda receives an exclusive license to Feraheme for all therapeutic applications in 5 regions, including Europe, Canada, Turkey, the Commonwealth of Independent States and Asia Pacific countries, excluding Japan, China and Taiwan.

· AMAG receives a $60 million upfront payment and is eligible to receive up to $220 million in development and commercial milestones. Additionally, AMAG will receive tiered, double-digit royalties based on net sales of Feraheme in the licensed territories.

· AMAG will execute and fund the global clinical development of Feraheme in all potential therapeutic indications. AMAG will also be initially responsible for the filing of regulatory applications for Feraheme in Europe and Canada, with Takeda responsible for the regulatory filings in all other regions covered by the agreement. Takeda will eventually hold all marketing authorizations in the licensed territories.

· Takeda will be responsible for commercializing Feraheme in all regions included in the licensed territories.

“One of our primary goals is to expand the reach of Feraheme to patients around the world with iron deficiency anemia,” said Brian J.G. Pereira, MD, President and Chief Executive Officer of AMAG Pharmaceuticals, Inc. “Takeda’s global presence, their pipeline that includes complementary products to Feraheme and their strength in the marketing and commercialization of therapeutics across many specialties where iron deficiency anemia is present makes them the ideal partner for Feraheme .”

“This partnership provides an exciting opportunity to combine AMAG’s unique development abilities with Takeda’s global commercialization capabilities,” said Alan MacKenzie, Executive Vice President, International Operations & CEO, Takeda Pharmaceuticals International, Inc. “Takeda is poised to maximize Feraheme ’s entry into the selected countries following approval.”

Currently , Feraheme is approved in the United States for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease. AMAG plans to submit a marketing authorization application to the European Medicines Agency (EMA) for Feraheme for the treatment of IDA in adult patients with chronic kidney disease in Europe in mid-2010. Additionally, AMAG plans to initiate a broad global registrational program for Feraheme for the treatment of IDA regardless of the underlying cause in mid-2010.

AMAG Conference Call and Webcast Access

AMAG Pharmaceuticals, Inc. will host a webcast and conference call today at 8:00 a.m. ET to discuss this announcement.

To access the conference call via telephone, please dial (877) 412-6083 from the United States or (702) 495-1202 for international access. A telephone replay will be available from approximately 11:00 a.m. ET on April 1, 2010 through midnight April 2, 2010. To access a replay of the conference call, dial (800) 642-1687 from the United States or (706) 645-9291 for international access. The passcode for the live call and the replay is 64493010.

The call will be webcast with slides and accessible through the Investors section of the Company’s website at www.amagpharma.com. The webcast replay will be available from approximately 11:00 a.m. ET on April 1, 2010 through midnight April 15, 2010.

About AMAG Pharmaceuticals, Inc.

AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its proprietary technology for the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease. On June 30, 2009, AMAG received approval from the U.S. Food and Drug Administration to market Feraheme® (ferumoxytol) Injection for intravenous (IV) use for the treatment of iron deficiency anemia in adult chronic kidney disease patients. For additional company and product information, please visit www.amagpharma.com.

About Takeda

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

Forward Looking Statements Related to AMAG

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to, statements regarding our plans to submit a market authorization application for Feraheme for the treatment of IDA in chronic kidney disease patients in the European Union and the timing of such submission and our plans to initiate a broad global registrational program for Feraheme for the treatment of IDA regardless of the underlying cause and the timing of such program initiation, the fact that Takeda will eventually hold all Marketing Authorization applications in the licensed territories, and our obligations under the agreement with Takeda are forward looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward looking statements. Such risks and uncertainties include: (1) uncertainties regarding our ability to successfully and timely complete our clinical development programs and obtain regulatory approval for Feraheme and compete in the intravenous iron replacement market outside of the U.S., (2) the fact that we have limited experience developing and commercializing a pharmaceutical product on our own or with a partner like Takeda, particularly outside of the U.S., (3) uncertainties regarding our ability to ensure favorable coverage, pricing and reimbursement for Feraheme , (4) uncertainties regarding our ability to manufacture Feraheme , (5) uncertainties relating to our patents and proprietary rights, (6) the fact that significant safety or drug interaction problems could arise with respect to Feraheme, and (7) other risks identified in our Securities and Exchange Commission filings, including our Annual Report on Form 10-K for the year ended December 31, 2009. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

Important Safety Information about Feraheme

Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with evidence of iron overload, known hypersensitivity to Feraheme or any of its components, and patients with anemia not caused by iron deficiency.

In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme . Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of subjects. Patients should be observed for signs and symptoms of hypersensitivity for at least 30 minutes following Feraheme injection and the drug should only be administered when personnel and therapies are

readily available for the treatment of hypersensitivity reactions. 1.9% (33/1,726) of Feraheme -treated subjects experienced hypotension. Please monitor for signs and symptoms of hypotension following each Feraheme injection. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy, noting that lab assays may overestimate iron and transferrin bound iron values in the 24 hours after administration of Feraheme . As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, (CT, PET, SPECT, ultrasound, or nuclear imaging.

In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients reported in > 2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%), nausea (3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs. 0.4%), constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs. 3.2%). In clinical trials, adverse reactions leading to treatment discontinuation and occurring in 2 or more Feraheme -treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.

Feraheme is a registered trademark of AMAG Pharmaceuticals, Inc.

AMAG Pharmaceuticals Contacts:

Amy Sullivan: +1-617-498-3303

Carol Miceli: +1-617-498-3361

Takeda Pharmaceuticals Contacts:

Seizo Masuda: +81 3 3278 2037

Nick Francis: +44 20 3116 8861

###

EXHIBIT F
DISPUTE RESOLUTION

All references to “days” in this ADR provision are to calendar days.

1. To begin an ADR proceeding, a Party shall provide written notice to the other Party of the issues to be resolved by ADR. Within [***] after its receipt of such notice, the other Party may, by written notice to the Party initiating the ADR, add additional issues to be resolved within the same ADR.

2. Within twenty-one (21) days following receipt of the original ADR notice, the Parties shall select a mutually acceptable panel of three (3) neutrals to preside in the resolution of any disputes in this ADR proceeding. If the Parties are unable to agree on a mutually acceptable panel of three (3) neutrals within such period, either Party may request the President of the International Institute for Conflict Prevention and Resolution (“CPR”), 575 Lexington Avenue, 21 st floor New York, New York 10022, to select a panel of three (3) neutrals pursuant to the following procedures:

(a) The CPR shall submit to the Parties a list of not less than nine (9) candidates within [***] after receipt of the request, along with a Curriculum Vitae for each candidate. No candidate shall be an employee, director, or shareholder of either Party or any of their Affiliates.

(b) Such list shall include a statement of disclosure by each candidate of any circumstances likely to affect his or her impartiality.

(c) Each Party shall number the candidates in order of preference (with the number one (1) signifying the greatest preference) and shall deliver the list to the CPR within [***] following receipt of the list of candidates. If a Party believes a conflict of interest exists regarding any of the candidates, that Party shall provide a written explanation of the conflict to the CPR along with its list showing its order of preference for the candidates. Any Party failing to return a list of preferences on time shall be deemed to have no order of preference.

(d) If the Parties collectively have identified fewer than four (4) candidates deemed to have conflicts, the CPR immediately shall designate as the panel of three (3) neutrals the three candidates for whom the Parties collectively have indicated the greatest preference. If a tie should result between two candidates, the CPR may designate either candidate. If the Parties collectively have identified four (4) or more candidates deemed to have conflicts, the CPR shall review the explanations regarding conflicts and, in its sole discretion, may either (i) immediately designate

as the neutral the candidate for whom the Parties collectively have indicated the greatest preference, or (ii) issue a new list of not less than nine (9) candidates, in which case the procedures set forth in subparagraphs 2(a) - 2(d) shall be repeated.

3. No earlier than [***] after selection, the panel shall hold a hearing to resolve each of the issues identified by the Parties. The ADR proceeding shall take place at a location agreed upon by the Parties. If the Parties cannot agree, the panel shall designate a location other than the principal place of business of either Party or any of their Affiliates. Commencing on the date [***] after receipt of the initial ADR notice described in paragraph 1 above, the Parties shall be entitled to engage in reasonable discovery under procedures of the Federal Rules of Civil Procedure; provided, however, that a party may not submit more than fifty (50) written interrogatories or take more than six (6) depositions. There shall not be any, and the panel shall not permit any, discovery [***]. The panel shall decide any disputes between the Parties related to discovery, including ruling on reasonable requests to expedite discovery, taking into account the applicable period of time for discovery.

4. At least [***] prior to the hearing, each Party shall submit the following to the other Party and the panel:

(a) a copy of all exhibits on which such Party intends to rely in any oral or written presentation to the panel;

(b) a list of any witnesses such Party intends to call at the hearing, and a short summary of the anticipated testimony of each witness;

(c) a proposed ruling on each issue to be resolved, together with a request for a specific damage award or other remedy for each issue. The proposed rulings and remedies shall not contain any recitation of the facts or any legal arguments and shall not exceed [***].

(d) a brief in support of such Party’s proposed rulings and remedies, provided that the brief shall not exceed [***]. This page limitation shall apply regardless of the number of issues raised in the ADR proceeding.

5. The hearing shall be conducted on [***] and shall be governed by the following rules:

(a) Each Party shall be entitled to [***] of hearing time to present its case. The panel shall determine whether each Party has had [***] to which it is entitled.

(b) Each Party shall be entitled, but not required, to make an opening statement, to present regular and rebuttal testimony, documents or other evidence, to cross-examine witnesses, and to make a closing argument. Cross-examination of witnesses shall occur immediately after their direct testimony, and cross-examination time shall be charged against the Party conducting the cross-examination.

(c) The Party initiating the ADR shall begin the hearing and, if it chooses to make an opening statement, shall address not only issues it raised but also any issues raised by the responding Party. The responding Party, if it chooses to make an opening statement, also shall address all issues raised in the ADR. Thereafter, the presentation of regular and rebuttal testimony and documents, other evidence, and closing arguments shall proceed in the same sequence.

(d) Except when testifying, witnesses shall be excluded from the hearing until closing arguments.

(e) Settlement negotiations, including any statements made therein, shall not be admissible under any circumstances. Affidavits prepared for purposes of the ADR hearing also shall not be admissible. As to all other matters, the panel shall have sole discretion regarding the admissibility of any evidence.

6. Within [***] following completion of the hearing, each Party may submit to the other Party and the panel a post-hearing brief in support of its proposed rulings and remedies, provided that such brief shall not contain or discuss any new evidence and shall not exceed [***]. This page limitation shall apply regardless of the number of issues raised in the ADR proceeding.

7. The panel shall rule on each disputed issue in writing within [***] following completion of the hearing. Such ruling shall adopt in its entirety the proposed ruling and remedy of one of the Parties on each disputed issue but may adopt one Party’s proposed rulings and remedies on some issues and the other Party’s proposed rulings and remedies on other issues. The panel shall not issue any written opinion or otherwise explain the basis of the ruling.

8. The panel shall be paid a reasonable fee plus expenses. These fees and expenses, along with the reasonable legal fees and expenses of the prevailing Party (including all expert witness fees and expenses), the fees and expenses of a court reporter, and any expenses for a hearing room, shall be paid as follows:

(a) If the panel rules in favor of one Party on all disputed issues in the ADR, the losing Party shall pay 100% of such fees and expenses.

(b) If the panel rules in favor of one Party on some issues and the other Party on other issues, the panel shall issue with the rulings a written determination as to how such fees and expenses shall be allocated between the Parties. The panel shall allocate fees and expenses in a way that bears a reasonable relationship to the outcome of the ADR, with the Party prevailing on more issues, or on issues of greater value or gravity, recovering a relatively larger share of its legal fees and expenses.

9. The rulings of a majority of the panel and the allocation of fees and expenses shall be binding, non-reviewable, and non-appealable, and may be entered as a final judgment in any court having jurisdiction.

10. Except as provided in paragraph 9 or as required by law, the existence of the dispute, any settlement negotiations, the ADR hearing, any submissions (including exhibits, testimony, proposed rulings, and briefs), and the rulings shall be deemed Confidential Information. The panel shall have the authority to impose sanctions for unauthorized disclosure of Confidential Information.

SCHEDULE 4.4(a)
Initial Studies

FER-CKD-201		Ferumoxytol Compared to Iron Sucrose Trial (FIRST): A Randomized, Multicenter, Trial of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects with Chronic Kidney Disease

[***]		[***]

AMAG-FER-IDA-302		A Phase III, Randomized, Open-label, Active-Controlled, Trial Comparing Ferumoxytol with Iron Sucrose for the Treatment of Iron Deficiency Anemia

SCHEDULE 4.4(b)
U.S. Studies and Pediatric Studies

AMAG-FER-CKD-251		A Randomized, Open-Label, Active-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of Ferumoxytol Compared with Oral Iron for the Treatment of Iron Deficiency Anemia in Pediatric Subjects with Dialysis-dependent Chronic Kidney Disease

AMAG-FER-CKD-252		A Randomized, Open-Label, Active-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of Ferumoxytol Compared with Oral Iron for the Treatment of Iron Deficiency Anemia in Pediatric Subjects with Nondialysis-dependent Chronic Kidney Disease

AMAG-FER-CKD-253		An Open-Label Extension Study of the Safety and Efficacy of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia in Pediatric Subjects with Chronic Kidney Disease

AMAG-FER-IDA-301		A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia

AMAG-FER-IDA-303		A Phase III, Open-Label Extension Trial of the Safety and Efficacy of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia

AMAG-FER-IDA-251		A Randomized, Open-Label, Active-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of Ferumoxytol Compared With Oral Iron for the Treatment of Iron Deficiency Anemia in Pediatric Subjects

SCHEDULE 5.1

Clinical Trials of the Product

STUDIES IN HEALTHY VOLUNTEERS

Type of Study		Phase I, PK and safety

Study Identifier		7228-01, “A Phase I clinical investigation of Code 7228” Start date: 09-June-1999; Completion date: 04-August-1999

Location of Study Report		Module 5.3.3.1

Objective(s) of the Study		To evaluate the PK and safety of ferumoxytol at increasing dose levels and at various rates of administration

Study Design and Type of Control		Randomized, double-blind, placebo-controlled, single center, ascending dose

Test Product(s): Dosage Regimen; Route of Administration		Ferumoxytol:1 mg Fe/kg, 2 mg Fe/kg, 4 mg Fe/kg; IV

Number of Subjects		N=41 (randomized): Ferumoxytol- 35; Placebo - 6

Healthy Subjects or Diagnosis of Patients		Healthy volunteers: M: 22; F: 19

Duration of Treatment		Single dose

Study Status; Type of Report		Complete; Full report CSR 7228-01

Type of Study		Phase 1, Thorough QTc and PK

Study Identifier		62,745-9, “A Phase I active and placebo-controlled study of the electrocardiogram effects and pharmacokinetics of ferumoxytol in healthy men and women” Start date: 22-May-2006; Completion date: 4-September-2006

Location of Study Report		Module 5.3.4.1

Objective(s) of the Study		To define the effect of ferumoxytol on the QT interval; to assess PK and tolerability

Study Design and Type of Control		Active- and placebo-controlled, randomized, double-blind (with respect to ferumoxytol and placebo), parallel group, single-center

Test Product(s): Dosage Regimen; Route of Administration		Ferumoxytol: Two 510 mg doses of ferumoxytol administered on two consecutive days Placebo (saline); IV Moxifloxacin (400 mg) as active control; Oral

Number of Subjects		174 Total (randomized): Ferumoxytol -58; Moxifloxacin -58; Placebo-58

Healthy Subjects or Diagnosis of Patients		Healthy volunteers: M:102, F:72

Duration of Treatment		2 x 510 mg doses of ferumoxytol administered on two consecutive days

Study Status; Type of Report		Complete; Full report CSR-62745-9

STUDIES IN PATIENTS WITH CHRONIC KIDNEY DISEASE

Type of Study		Phase I, PK and safety

Study Identifier		62,745-2, “A Phase I open-label, rate administration, pharmacokinetic study of the safety of Code 7228 as an iron replacement therapy in chronic hemodialysis patients who are receiving supplemental EPO therapy” Start date: 26-Sep-2001; Completion date: 10-Apr-2002

Location of Study Report		Module 5.3.3.2

Objective(s) of the Study		The objective of this study was to evaluate the safety and PK of two doses (125 and 250 mg) of ferumoxytol in subjects with CKD stage 5D who were on HD and receiving supplemental EPO therapy

Study Design and Type of Control		Open-label, single center; Uncontrolled

Test Product(s): Dosage Regimen; Route of Administration		Ferumoxytol: 1 x 125 mg, 1 x 250 mg; IV

Number of Subjects		20 Total (enrolled): Ferumoxytol 125 mg — 10; Ferumoxytol 250 mg - 10

Healthy Subjects or Diagnosis of Patients		Patients with CKD stage 5D on hemodialysis; M: 10, F: 10

Duration of Treatment		Single dose

Study Status; Type of Report		Complete; Full report CSR-62745-2

Type of Study		Phase II, Safety/Efficacy

Study Identifier		62,745-3, “A Phase II, Open-Label Study of the Safety and Efficacy of Two Parenteral Dose Regimens of Code 7228 (Compared With Oral Iron) as an Iron Replacement Therapy in Chronic Hemodialysis Patients Who Are Receiving Supplemental EPO Therapy” Start date: 20-Jan-2003; Completion date: 19-June-2003

Location of Study Report		Module 5.3.5.1

Objective(s) of the Study		To evaluate the safety and efficacy of two parenteral dose regimens of ferumoxytol compared with oral iron

Study Design and Type of Control		Multicenter, open label; Active control

Test Product(s): Dosage Regimen; Route of Administration		Ferumoxytol: 8 x 128 mg, 2 x 510 mg; IV Oral iron: 325 mg per day

Number of Subjects		36 Total (enrolled): Ferumoxytol 8 x 128 mg - 15; Ferumoxytol 2 x 510 mg — 11; Oral iron - 10

Healthy Subjects or Diagnosis of Patients		Patients with CKD stage 5D on hemodialysis: M: 21, F: 15

Duration of Treatment		8 x 128 mg doses of ferumoxytol within 4 weeks; 2x 510 mg of ferumoxytol within 2 weeks; daily oral iron for 8 sequential dialysis sessions (approx. 3 weeks)

Study Status; Type of Report		Complete; Full report CSR-62745-3

Type of Study		Phase II, Safety/Efficacy

Study Identifier		62,745-4, “A Phase II, Open-Label Study of the Safety and Efficacy of Two Parenteral Dose Regimens of Code 7228 (Ferumoxytol) as an Iron Replacement Therapy in Chronic Kidney Disease Patients or Patients on Peritoneal Dialysis” Start date: 07-Oct-2002; Completion date: 27-Dec-2002

Location of Study Report		Module 5.3.5.2

Objective(s) of the Study		To evaluate the safety and efficacy of two parenteral dose regimens of ferumoxytol in subjects with chronic renal failure (not on dialysis), or who were on PD

Study Design and Type of Control		Multicenter, open label; Uncontrolled

Test Product(s): Dosage Regimen; Route of Administration		Ferumoxytol: 4 x 255 mg, 2 x 510 mg; IV

Number of Subjects		21 Total (enrolled): Ferumoxytol 4 x 255 mg - 10; Ferumoxytol 2 x 510 mg - 11

Healthy Subjects or Diagnosis of Patients		Patients with CKD stages 1-5 not on hemodialysis; M: 9, F: 12

Duration of Treatment		4 x 255 mg of ferumoxytol each separated by 2-3 days; 2 x 510 mg doses of ferumoxytol each separated by 2-3 days

Study Status; Type of Report		Completed; Full report CSR-62745-4

Type of Study		Phase III, Safety/Efficacy

Study Identifier		62,745-5, “A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared with Oral Iron) as an Iron Replacement Therapy in Hemodialysis Patients who are Receiving Supplemental Erythropoietin Therapy” Start date: 09-Aug-2004; Completion date: 24-Apr-2007

Location of Study Report		Module 5.3.5.1

Objective(s) of the Study		To evaluate the safety and efficacy of ferumoxytol versus oral iron as an iron replacement therapy in subjects with CKD stage 5D on HD who were receiving supplemental ESA therapy

Study Design and Type of Control		Randomized, multicenter, open label; Active control

Test Product(s): Dosage Regimen; Route of Administration		Ferumoxytol: Post-amendment: 2 x 510 mg; Pre-amendment: 4 x 255 and 2 x 510 mg; IV Oral iron: 200 mg per day

Number of Subjects		378 Total (randomized): Post-amendment: 230 Total; Ferumoxytol -114; Oral Iron-116 Pre-amendment: 148 Total; Ferumoxytol 4x255 mg — 62; Ferumoxytol -2x510 mg - 64; Oral Iron - 22

Healthy Subjects or Diagnosis of Patients		Patients with CKD stage 5D on hemodialysis; Post- amendment: M: 130, F: 100; Pre-amendment: M: 63, F: 85

Duration of Treatment		2 x 510 mg doses ferumoxytol within 7 days; 4 x 255 mg doses of ferumoxytol, within 14 days; or oral iron for 21 consecutive days

Study Status; Type of Report		Complete; Full report CSR 62745-5

Type of Study		Phase III, Safety/Efficacy

Study Identifier		62,745-6, “A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared with Oral Iron) as an Iron Replacement Therapy in chronic kidney disease patients not on dialysis” Start date: 10-May-2004; Completion date: 25-Sep-2006

Location of Study Report		Module 5.3.5.1

Objective(s) of the Study		To evaluate the safety and efficacy of ferumoxytol versus oral iron for iron replacement therapy in subjects with CKD stages 1-5

Study Design and Type of Control		Randomized, multicenter, open label; Active control

Test Product(s): Dosage Regimen; Route of Administration		Ferumoxytol; 2 x 510 mg; IV; Oral iron: 200 mg per day

Number of Subjects		304 Total (randomized): Ferumoxytol - 228; Oral Iron - 76

Healthy Subjects or Diagnosis of Patients		Patients with CKD stages 1-5: M: 118, F: 186

Duration of Treatment		2 x 510 mg doses of ferumoxytol within 5±3 days, or 21 consecutive days of oral iron

Study Status; Type of Report		Complete; Full report CSR-62745-6

Type of Study		Phase III, Safety/Efficacy

Study Identifier		62,745-7, “A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared with Oral Iron) as an Iron Replacement Therapy in chronic kidney disease patients not on dialysis” Start date: 02-June-2004; Completion date: 20-Dec-2006

Location of Study Report		Module 5.3.5.1

Objective(s) of the Study		To evaluate the safety and efficacy of ferumoxytol versus oral iron for iron replacement therapy in subjects with CKD stages 1-5

Study Design and Type of Control		Randomized, multicenter, open label; Active control

Test Product(s): Dosage Regimen; Route of Administration		Ferumoxytol: 2 x 510 mg; IV Oral iron: 200 mg per day

Number of Subjects		304 Total (randomized): Ferumoxytol - 227; Oral Iron — 77

Healthy Subjects or Diagnosis of Patients		Patients with CKD stages 1-5; M: 125, F: 179

Duration of Treatment		Two IV doses of ferumoxytol within 5±3 days, or 21 consecutive days of oral iron

Study Status; Type of Report		Complete; Full report CSR-62745-7

Type of Study		Phase III, Safety

Study Identifier		62,745-8, “A Double Blind, Placebo Controlled, Crossover Design, Multicenter Study of Intravenous Ferumoxytol Compared with Placebo” Start date: 27-Jan-2005; Completion date: 6-Sep-2006

Location of Study Report		Module 5.3.5.1

Objective(s) of the Study		To compare the safety of a single 510 mg dose of IV ferumoxytol versus a single dose of IV saline placebo in subjects with all stages of CKD

Study Design and Type of Control		Randomized, multicenter, double-blind, placebo controlled, crossover design

Test Product(s): Dosage Regimen; Route of Administration		Ferumoxytol; 1 x 510 mg; IV Placebo (saline); IV

Number of Subjects		N=750 (randomized)

Healthy Subjects or Diagnosis of Patients		Patients with CKD stages 1-5 and 5D: M: 347, F: 403

Duration of Treatment		A single dose, followed by the crossover dose 7±2 days later

Study Status; Type of Report		Complete; Full report CSR-62745-8

STUDIES IN MEDICAL IMAGING SUBJECTS (PATIENTS AND HEALTHY VOLUNTEERS)

Type of Study		Phase I/IIA, Safety

Study Identifier		58,254-2, “ A Phase I/IIa Pilot Investigation Of Code 7228 As A Magnetic Resonance Angiography Contrast Agent” Start date: 01-Nov-2001; Completion date: 11-May-2002

Location of Study Report		Module 5.3.5.4

Objective(s) of the Study		To evaluate the safety and imaging feasibility of ferumoxytol

Study Design and Type of Control		Open label, single center; Uncontrolled

Test Product(s): Dosage Regimen; Route of Administration		Ferumoxytol; < 4 mg Fe/kg; IV

Number of Subjects		17 Total (enrolled): Healthy volunteers — 10; Imaging patients - 7

Healthy Subjects or Diagnosis of Patients		Healthy volunteers and imaging patients: M: 12, F: 5

Duration of Treatment		Single dose

Study Status; Type of Report		Complete; Abbreviated report CSR-58254-2

Type of Study		Phase II, Safety

Study Identifier		58,254-5, “A Phase 2 Investigation of Code 7228 as a Magnetic Resonance Angiography Contrast Agent” Start date: 7-Aug-2002; Completion date: 6-Sep-2005

Location of Study Report		Module 5.3.5.4

Objective(s) of the Study		To evaluate the safety and imaging feasibility of ferumoxytol

Study Design and Type of Control		Open label, single center; Uncontrolled

Test Product(s): Dosage Regimen; Route of Administration		Ferumoxytol: < 4 mg Fe/kg; IV

Number of Subjects		49 Total (enrolled): Healthy volunteers - 15; Imaging patients - 34

Healthy Subjects or Diagnosis of Patients		Healthy volunteers and imaging patients; M: 29, F: 20

Duration of Treatment		Single or incremental dose within the same imaging session

Study Status; Type of Report

Complete; Abbreviated report CSR-58254-5

CKD: Chronic kidney disease; HD: Hemodialysis; PK: Pharmacokinetics; IV: Intravenous; M: Male; F: Female; ESA: Erythropoiesis stimulating agent; PD: Peritoneal dialysis; CSR: Clinical study report; N/A: Not applicable.

SCHEDULE 7.2

SUPPLY AGREEMENT TERMS

This Schedule 7.2 describes the basic scope and principles to be included in the Supply Agreement, which will govern supply of Takeda’s requirements of both clinical and commercial quantities of the Product pursuant to the terms of Article 7 of the License, Development and Commercialization Agreement (the “Agreement”).

Scope

1) Each Party shall appoint appropriate representatives to negotiate the Supply Agreement.

2) This Schedule 7.2 is not intended to include all terms and conditions anticipated to be included in the Supply Agreement. The Supply Agreement will describe and define the procedures, terms and conditions for forecasting, manufacture, quality assurance, delivery, price, payment and appropriate other activities relating to the supply of the Product in the Field and in the Licensed Territory consistent with the terms described below and will contain such other terms and conditions customarily contained in supply agreements in the pharmaceutical industry, including without limitation warranties and indemnities.

General

1) Takeda shall purchase exclusively from AMAG, and AMAG shall supply, all of Takeda’s and its Affiliates’ and its/their sublicensees’ requirements of the Product, except as otherwise provided in this Schedule 7.2 and the Agreement. AMAG shall supply Takeda (either by itself or through its Designated Second Source Suppliers (each, a “ DSS ”)) with the Product in unlabeled finished form for use under the Agreement and in accordance with the terms of the Supply Agreement.

2) The term of the Supply Agreement shall be coextensive with the Term of the Agreement.

3) AMAG shall use Commercially Reasonable Efforts to manage Takeda’s supply needs (e.g., volumes and unit costs) for the Licensed Territory in a manner proportionate to AMAG’s supply needs outside the Licensed Territory.

Price/ Payment

1) The purchase price for commercial and clinical supply shall be [***].

[***]

2) The Supply Agreement will include a mechanism for applying annual volume-based pricing, which may include an annual true-up or other adjustment mechanism agreed by the Parties.

3) “Fully Burdened Manufacturing Cost” means the consolidated fully burdened cost incurred by AMAG in the Manufacture of Product (calculated in accordance with GAAP) of the following items: (i) direct and indirect cost of any materials; (ii) direct labor costs (including benefits); (iii) factory overhead (fixed and variable); (iv) operating costs of facilities and equipment (including idle plant capacity); (v) a charge for depreciation and repairs and maintenance costs of facilities and equipment; (vi) quality and in-process control costs; and (vii) charges for spoilage and scrap. Each such cost described in items (i) through (vii) above shall be determined in accordance with AMAG’s accounting practices applied on a normal and customary basis by AMAG consistent with its practices. Notwithstanding the foregoing, Fully Burdened Manufacturing Cost shall not include any costs for unusable batches resulting from AMAG’s failure to conduct its manufacturing activities in accordance with the terms of the Supply Agreement or any profit related to inter-company transfer pricing. To the extent that a Product, or any component thereof, is Manufactured for AMAG by a Third Party, amounts paid by AMAG to such Third Party directly for Manufacture will be added, without mark up, to the aggregate amount of the foregoing items. The Parties acknowledge and agree that [***].

4) Payment terms are [***] from receipt of invoice (invoice will not be issued prior to shipment).

5) [***]

6) AMAG shall consult with Takeda regarding any capital equipment proposed to be acquired for use in supplying Product to Takeda and for which Takeda would bear all or some portion of the costs. Takeda will be responsible to AMAG for any capital equipment expenditures made after the Effective Date to the extent attributable to AMAG’s supply of Product to Takeda for the Licensed Territory where Takeda agrees to such expenditures or to the extent that such capital equipment purchase is reasonably necessary to the manufacture of the Product for

the Licensed Territory. If any such equipment is attributable to both the Licensed Territory and outside the Licensed Territory, the Parties will use good faith efforts to agree on a reasonable allocation of such expenditures to the Licensed Territory and outside the Licensed Territory, based on the volumes supplied for each such territory. The Supply Agreement will include a mechanism for resolving any disagreement between the Parties as to the acquisition of any such equipment and/or the allocation between the Parties of the expenditure.

Forecasting and Ordering

1) Commencing twelve (12) months prior to the anticipated First Commercial Sale of the Product in the Licensed Territory, and at the beginning of each calendar quarter thereafter, Takeda shall provide AMAG with twelve (12) month rolling forecasts of its requirements of the Product for the Licensed Territory, [***] of which shall be binding. Each such forecast shall be consistent with Takeda’s projected commercial sales of the Product in the Licensed Territory on a quarterly basis. If the First Commercial Sale of the Product is delayed, upon Takeda’s request, AMAG will use Commercially Reasonable Efforts to utilize outside of the Licensed Territory those quantities of Product representing the binding portion of such forecasts.

2) If Takeda places an order exceeding its forecast for the period to which the purchase order applies, AMAG shall supply up to [***] of Takeda’s forecasted quantities for such period. AMAG shall use Commercially Reasonable Efforts to supply Takeda with any quantities of Product over [***] of the relevant forecast for such period. For clarity, any capital expenditure required for such increased amounts shall be addressed through the mechanism above in Price/Payment (item 6).

3) The Supply Agreement will contain mutually agreed information sharing and planning procedures with respect to the forecasting, supply and quality of the Product, including a mechanism for addressing increases and decreases to the non-binding portion of Takeda’s forecast.

Delivery

Delivery requirements, location and Incoterms shall be defined in the Supply Agreement.

Manufacture and Quality Control

1) Product shall be manufactured in compliance with cGMP, as defined by Regulatory Authorities within the Licensed Territory. The Product shall be manufactured according to specifications for the Product set forth in the Supply Agreement (“Specifications”), which initially shall be the specifications for Product supplied by AMAG for the U.S. as of the Effective Date.

2) The Supply Agreement will contain change control procedures for the Specifications and other related matters. Change requests will be made pursuant to a written change request process agreed by both parties. The change request process will also document any changes to estimated timelines and costs. The parties must mutually agree to any changes to the Specifications, including any changes that require prior approval by a Regulatory Authority. Takeda will bear the cost of any approved changes to the extent requested by it or implemented in connection with any change to comply with regulatory requirements or any Regulatory Approval in the Licensed Territory; provided that AMAG shall use Commercially Reasonable Efforts to implement such changes in a cost-effective manner.

3) The Supply Agreement shall define a procedure for notification of each party in the event of a product complaint from the field or product recall.

4) The Supply Agreement shall define a procedure for resolution of any disputes regarding product quality.

5) The Supply Agreement shall define safety and waste handling procedures relating to the Product and its Manufacture.

6) Some or all of items (1)-(5) may be included in the quality agreement (as described below).

7) Each Party will have a reciprocal audit right allowing, during regular business hours, reasonable access by the other Party’s quality assurance, quality control, compliance and other relevant personnel (including the other Party’s consultants who are under the same confidentiality and limited use obligations under this Agreement), upon reasonable notice, to audit its facilities and/or its contract manufacturing/laboratory sites where the Product is manufactured, packaged, labeled and/or tested, and shall allow reasonable access to related documentation; provided that AMAG shall have the right to redact CMC Information from any documentation provided to Takeda. The purpose of such audit shall be to assess compliance with the cGMP and applicable Laws in the country of manufacture.

Transfer of Analytical Methods (QA)

The Supply Agreement will contain mutually acceptable provisions regarding release testing of the Product and, if applicable, the transfer of information necessary for Takeda to perform required quality testing, as applicable.

Quality Agreement

The parties will work in good faith to complete a quality agreement on a mutually agreed time frame prior to First Commercial Sale of the Product, or as soon as practicable following the Effective Date if the Parties determine a quality agreement is necessary with respect to clinical supply of Product.

Second Source / Safety Stock

1) The Supply Agreement will contain detailed procedures for implementing the Second Source Plan in accordance with Section 7.3 of the Agreement and this Schedule 7.2.

2) AMAG shall pay all costs associated with qualifying, initiating and maintaining each DSS as set forth in the Second Source Plan as of the Effective Date. Costs for additional qualification, initiation and maintenance of such DSSs or additional designated second source suppliers will be allocated between AMAG and Takeda to the extent attributable to outside the Licensed Territory and the Licensed Territory, respectively. The Parties shall use good faith efforts to agree on a reasonable allocation, based on the volumes supplied for each such territory.

3) AMAG and/or its DSS shall manufacture and maintain at a designated facility at AMAG’s expense a safety stock of Product inventory exclusive to Takeda in an amount equal to [***] in accordance with the terms of the Supply Agreement. On a quarterly basis, AMAG shall inform Takeda of the then-current inventory and other relevant information for the safety stock. AMAG shall have the right to supply Takeda Product from the safety stock. AMAG shall use Commercially Reasonable Efforts to restore safety stock as soon as reasonably practicable. The Supply Agreement will include a mechanism to address the situation where AMAG is unable to restore safety stock to the required level within a mutually agreed time period.

4) AMAG shall have the right to use a DSS for the supply of Product to Takeda for the Licensed Territory (e.g., to supplement existing capacity, to purchase safety stock, or to obtain more favorable pricing for AMAG and Takeda). AMAG shall notify and consult with Takeda regarding any such decision and keep Takeda reasonably informed of its use of the DSS. AMAG will consider Takeda’s comments to such arrangement in good faith and use Commercially Reasonable Efforts to ensure that Takeda’s current and anticipated demand of the Product, consistent with amounts forecasted by Takeda, will be met in accordance with the terms of the Supply Agreement, and that any incremental cost for supply of

Product from the DSS is reasonably allocated to the Licensed Territory and outside the Licensed Territory, based on the volume demands of each such territory. In the event AMAG sources Product to supply to Takeda from a DSS, AMAG shall provide such Product to Takeda [***].

5) If Takeda anticipates specific Product sourcing needs in a Product configuration not in existence as of the Effective Date (e.g., package size or dosage form specific to the Licensed Territory), Takeda shall notify AMAG, and the Parties shall meet to discuss such needs in good faith and a reasonable means for satisfying Takeda’s request for Product. The Parties anticipate that AMAG shall be the supplier of such Product. AMAG shall use Commercially Reasonable Efforts to satisfy Takeda’s new Product supply needs itself or through one or more DSS, subject to the Parties’ mutual written consent, not to be unreasonably withheld. [***] If any such expenses are attributable to both the Licensed Territory and outside the Licensed Territory, the Parties will use good faith efforts to agree on a reasonable allocation of such expenses to the Licensed Territory and outside the Licensed Territory, based on the volumes supplied for each such territory.

6) As to be further detailed in the Supply Agreement, Takeda shall have the right to obtain Product for use in the Licensed Territory from a DSS through a contract to which AMAG is a party upon the following events: (A) an Insolvency Event of AMAG, (B) a failure by AMAG, in any calendar quarter, to supply in accordance with the terms of the Supply Agreement at least [***] (C) a failure by AMAG, in each of two (2) consecutive calendar quarters, to supply in accordance with the terms of the Supply Agreement [***] (each of (A) through (C), a “ Transfer Event ”). Upon the occurrence of a Transfer Event, Takeda shall notify AMAG of its intent to source from the DSS and shall have the right to purchase from the DSS that amount of Product that AMAG failed to supply based upon Takeda’s binding purchase orders, plus any additional amount that takes into consideration the current deficit (if any) in safety stock, Takeda’s customer’s orders for the applicable calendar quarter, and minimum batch sizes or other minimum supply requirements imposed by a DSS. For clarity, Takeda’s rights under this item (6) (and the licenses granted in Section 2.1(a) of the Agreement) are limited solely to obtaining Product from a DSS, and Takeda shall have no right to receive (or provide to any Third Party) any AMAG Know-How related to Manufacturing of the Product except for the CMC Information expressly provided in the Agreement or to the extent that disclosure of AMAG Know-How is reasonably required for Takeda to Finish the Product. The Supply Agreement shall detail AMAG’s obligations to make all reasonably necessary arrangements with its DSS, which

may include, but is not limited to, amendment of its supply agreement with a DSS, to ensure that Takeda has the right and ability to fully exercise its rights under the Supply Agreement, to purchase its requirements of Product (including drug substance) from a DSS upon the occurrence of a Transfer Event.

7) If Takeda purchases Product from a DSS following a Transfer Event as provided above, [***]. So long as AMAG uses Commercially Reasonable Efforts to meet Takeda’s forecasted purchase of Product under the Supply Agreement and uses Commercially Reasonable Efforts to work with the DSS to supply Product to Takeda in accordance with the Second Source Plan (including using Commercially Reasonable Efforts to manage demand and supply of the Product, taking into consideration the demand for Product for the Licensed Territory and outside the Licensed Territory), such right to purchase Product from a DSS [***] shall not be applicable if such failure to supply is caused by AMAG’s or its DSS’s (i) failure to comply with applicable Laws relating to the Manufacture of the Product or (ii) gross negligence or wilful misconduct.

8) Following a Transfer Event, Takeda shall resume purchasing all of its requirements for the Product from AMAG (and cease purchasing from a DSS), exercising Commercially Reasonable Efforts, within a reasonable time frame after AMAG’s: (A) reasonably demonstrating that it is able to supply Product in accordance with the terms of the Supply Agreement and Takeda’s forecast and (B) manufacturing and maintaining a [***] of safety stock of drug substance for the Product exclusive to Takeda (in addition to its safety stock of Product), taking into account any residual Product purchase and other obligations to the DSS.

9) If, after [***], AMAG is unable to meet Takeda’s forecasted demand for the Product, then Takeda shall obtain, at its expense, the Product from the DSS [***]. In such event, AMAG shall no longer be obligated to supply Product directly to Takeda (and Takeda shall no longer be obligated to purchase Product directly from AMAG), and Takeda will have the right to purchase all of its requirements of the Product directly from a DSS as Takeda’s primary source of supply of the Product. AMAG will reasonably cooperate with Takeda in the transition to the DSS. In addition, AMAG shall undertake promptly, using Commercially Reasonable Efforts, to identify, qualify and maintain a new Designated Second Source Supplier reasonably acceptable to the Parties for drug substance and Product. The Supply Agreement will include a mechanism for allocating costs for such activities with respect to such new Designated Second Source Supplier between the Parties.

10) Notwithstanding anything in this Schedule 7.2 to the contrary, [***], if the Acquiror is conducting human clinical studies with or commercializing in the Licensed Territory any pharmaceutical product containing or comprising iron as the primary active pharmaceutical ingredient formulated for delivery by parenteral means at the closing of the acquisition of AMAG, then:

(a) the conditions under clauses (B) and (C) in item (6) above shall be modified as follows: (i) [***]

(b) AMAG’s requirement to maintain safety stock of Product inventory shall [***].

Product Warranty

AMAG will provide standard warranties applicable in the pharmaceutical industry, including warranties that all Product Manufactured by or on behalf of AMAG:

i) shall be manufactured and tested in accordance with all applicable laws, rules, regulations or guidelines of any relevant Regulatory Authority, and GMPs applicable to, without limitation, the manufacturing, storage, and shipment of Product,

ii) shall not be adulterated or misbranded within the meaning of the United States Food, Drug and Cosmetic Act, 21 U.S.C. Section 301c et. seq., or other applicable laws, rules, regulations or guidelines of any relevant Regulatory Authority,

iii) at the time of delivery to Takeda will meet the Specifications, and

iv) will have a shelf life of a commercially viable period of [***].

SCHEDULE 7.3

SECOND SOURCE PLAN

The following plan outlines AMAG’s current plan for the availability of primary and secondary manufacturers of API (drug substance) and drug product for the Licensed Territory.

[***]

Secondary Supply Source

AMAG has developed a plan to provide for alternative (secondary) sources for both drug substance and drug product for the EU (see attachment 1).

[***]

[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

TABLE OF CONTENTS

		PAGE

ARTICLE 1	DEFINITIONS	1

ARTICLE 2	LICENSES AND EXCLUSIVITY	13

2.1	Licenses to Takeda under AMAG Technology	13

2.2	License to AMAG	15

2.3	Negative Covenant	16

2.4	Right of First Negotiation	16

2.5	No Implied Licenses	16

2.6	Exclusivity	16

2.7	Cross-Territorial Restrictions	17

ARTICLE 3	MANAGEMENT	18

3.1	Joint Steering Committee	18

3.2	Joint Development Committee	19

3.3	Committee Membership and Procedures	20

3.4	Alliance Managers	21

3.5	Collaboration Guidelines	22

ARTICLE 4	PRODUCT DEVELOPMENT	22

4.1	Overview of Product Development	22

4.2	Principles of Product Development	22

4.3	Development Plan	22

4.4	AMAG Development Responsibilities	23

4.5	Other AMAG Studies	27

4.6	Takeda Product Development	27

4.7	Development Diligence	28

4.8	Reports	28

4.9	Development Costs	28

4.10	Delayed Opt-In	29

4.11	Data Exchange and Use	30

4.12	Cooperation; Compliance with Laws	31

4.13	Records, Reports and Information	31

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(CONTINUED)

		PAGE

ARTICLE 5	REGULATORY MATTERS	31

5.1	Data and Information Transfer	31

5.2	Regulatory Responsibilities	32

5.3	Regulatory Costs and Expenses	33

5.4	Preparation of Regulatory Materials	33

5.5	Rights of Reference to Regulatory Materials	34

5.6	Adverse Event Reporting and Safety Data Exchange	34

5.7	Regulatory Authority Communications Received by a Party	35

5.8	Regulatory Safety Reporting	35

5.9	Audit	36

ARTICLE 6	COMMERCIALIZATION	36

6.1	Overview of Commercialization in the Licensed Territory	36

6.2	Commercialization Plan for Licensed Territory	37

6.3	Pricing	37

6.4	Commercial Diligence	37

6.5	Reports	38
38
6.6	Tracking Sales of Product in the Field and Outside the Field	38

6.7	Product Trademarks and House Marks	38

ARTICLE 7	MANUFACTURE AND SUPPLY	40

7.1	General Supply Terms	40

7.2	Supply Agreement	40

7.3	Second Source	40

7.4	Recalls and Voluntary Withdrawals	40

ARTICLE 8	COMPENSATION	41

8.1	Upfront Fee	41

8.2	Development Milestone Payments	41

8.3	Commercialization Milestone Payments in the Licensed Territory	42

8.4	Royalties	43

8.5	Third Party Royalties	44

8.6	Royalty Reports and Payment	45

TABLE OF CONTENTS

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		PAGE

8.7	Foreign Exchange	45

8.8	Payment Method; Late Payments	45

8.9	Records; Audits	45

8.10	Taxes	46

ARTICLE 9	INTELLECTUAL PROPERTY MATTERS	47

9.1	Ownership of Inventions; Assignment	47

9.2	Disclosure of Inventions	47

9.3	Prosecution of Patents	47

9.4	Patent Term Extensions in the Licensed Territory	48

9.5	Infringement of Patents by Third Parties	49

9.6	Infringement of Third Party Rights in the Licensed Territory	50

9.7	Patent Marking	51

9.8	Patent Oppositions and Other Proceedings	51

ARTICLE 10	REPRESENTATIONS AND WARRANTIES; COVENANTS	52

10.1	Mutual Representations and Warranties	52

10.2	Additional Representations and Warranties of AMAG	53

10.3	Covenants	55

10.4	Disclaimer	55

10.5	No Other Representations or Warranties	55

ARTICLE 11	INDEMNIFICATION	56

11.1	Indemnification by AMAG	56

11.2	Indemnification by Takeda	56

11.3	Indemnification Procedures	57

11.4	Limitation of Liability	57

11.5	Insurance	57

ARTICLE 12	CONFIDENTIALITY	58

12.1	Confidentiality	58

12.2	Authorized Disclosure	58

12.3	Publicity	59

iii

TABLE OF CONTENTS

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		PAGE

ARTICLE 13	TERM AND TERMINATION	60

13.1	Term	60

13.2	Unilateral Termination by Takeda	60

13.3	Termination for Breach	61

13.4	Termination for Patent Challenge	61

13.5	Termination for Bankruptcy	62

13.6	AMAG Rights upon Termination of the Agreement	62

13.7	Rights in Bankruptcy	63

13.8	Survival	63

ARTICLE 14	DISPUTE RESOLUTION	63

14.1	Disputes	63

14.2	Referred from JSC	64

14.3	Arising Between the Parties	65

14.4	ADR	65

14.5	Patent and Trademark Disputes	65

14.6	Injunctive Relief	65

14.7	WAIVER OF RIGHT TO JURY TRIAL	65

ARTICLE 15	STANDSTILL	66

15.1	Standstill Agreement	66

15.2	Exceptions to Standstill	67

15.3	Reinstatement of Standstill	68

15.4	Most Favored Nations Treatment	68

ARTICLE 16	MISCELLANEOUS	68

16.1	Entire Agreement; Amendment	68

16.2	Force Majeure	69

16.3	Notices	69

16.4	No Strict Construction; Headings	70

16.5	Assignment	70

16.6	Performance by Affiliates	71

16.7	Further Actions	71

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		PAGE

16.8	Severability	71

16.9	No Waiver	71

16.10	Independent Contractors	71

16.11	English Language; Governing Law	72

16.12	Counterparts	72

Exhibit 31.1

CERTIFICATIONS

I, Brian J.G. Pereira, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of AMAG Pharmaceuticals, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 6, 2010

	/s/ Brian J.G. Pereira
	Brian J.G. Pereira
	Chief Executive Officer and President
	(principal executive officer)

Exhibit 31.2

CERTIFICATIONS

I, David A. Arkowitz, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of AMAG Pharmaceuticals, Inc.;

3. Based on my knowledge, the financial statements, and other financial information included in this quarterly 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;

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 6, 2010
	/s/ David A. Arkowitz
	David A. Arkowitz
	Executive Vice President, Chief Financial Officer and Chief Business Officer
	(principal financial and accounting officer)

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 of AMAG Pharmaceuticals, Inc., or the Company, on Form 10-Q for the period ended March 31, 2010 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Brian J.G. Pereira, Chief Executive Officer and President of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:

(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.

	/s/ Brian J.G. Pereira
	Brian J.G. Pereira
	Chief Executive Officer and President
May 6, 2010

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 of AMAG Pharmaceuticals, Inc., or the Company, on Form 10-Q for the period ended March 31, 2010 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, David A. Arkowitz, Executive Vice President, Chief Financial Officer and Chief Business Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:

(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.

	/s/ David A. Arkowitz
	David A. Arkowitz
	Executive Vice President, Chief Financial Officer and Chief
	Business Officer
May 6, 2010