AMAG PHARMACEUTICALS INC. (Form: 10-Q, Received: 08/07/2013 16:09:27)

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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 June 30, 2013

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

For the transition period from to

Commission file number 001-10865

AMAG Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Its Charter)

Delaware		04-2742593
(State or Other Jurisdiction of		(I.R.S. 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 x No o

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

Large accelerated filer o

Accelerated filer x

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 Act). Yes o No x

As of July 31, 2013, there were 21,687,442 shares of the registrant’s common stock, par value $0.01 per share, outstanding.

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AMAG PHARMACEUTICALS, INC.
FORM 10-Q

TABLE OF CONTENTS

PART I.	FINANCIAL INFORMATION (Unaudited)
Item 1.	Financial Statements
	Condensed Consolidated Balance Sheets as of June 30, 2013 and December 31, 2012	4
	Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2013 and 2012	5
	Condensed Consolidated Statements of Comprehensive Loss for the three and six months ended June 30, 2013 and 2012	6
	Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2013 and 2012	7
	Notes to Condensed Consolidated Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	28
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	52
Item 4.	Controls and Procedures	52

PART II.	OTHER INFORMATION
Item 1.	Legal Proceedings	53
Item 1A.	Risk Factors	54
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	83
Item 6.	Exhibits	84

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)

	June 30, 2013			December 31, 2012
*ASSETS*
Current assets:
Cash and cash equivalents	$	27,802		$	46,293
Investments	184,611			180,750
Accounts receivable, net	8,490			6,410
Inventories	13,474			12,451
Receivable from collaboration	368			263
Assets held for sale	1,934			2,000
Prepaid and other current assets	5,658			6,213
Restricted cash	460			460
Total current assets	242,797			254,840
Property and equipment, net	1,913			3,297
Intangible assets, net	17,192			—
Restricted cash	400			—
Total assets	$	262,302		$	258,137
*LIABILITIES AND STOCKHOLDERS’ EQUITY*
Current liabilities:
Accounts payable	$	2,443		$	3,515
Accrued expenses	18,256			20,338
Deferred revenues	9,269			9,104
Total current liabilities	29,968			32,957
Long-term liabilities:
Deferred revenues	46,402			50,350
Acquisition-related contingent consideration, net of current portion	13,044			—
Other long-term liabilities	1,806			2,033
Total liabilities	91,220			85,340
Commitments and contingencies (Notes M & N)
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; 21,652,941 and 21,506,754 shares issued and outstanding at June 30, 2013 and December 31, 2012, respectively	217			215
Additional paid-in capital	637,261			632,487
Accumulated other comprehensive loss	(3,935		)	(3,247		)
Accumulated deficit	(462,461		)	(456,658		)
Total stockholders’ equity	171,082			172,797
Total liabilities and stockholders’ equity	$	262,302		$	258,137

The accompanying notes are an integral part of these 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 June 30,						Six Months Ended June 30,
	2013			2012			2013			2012
Revenues:
U.S. Feraheme product sales, net	$	17,456		$	14,094		$	33,034		$	27,720
License fee and other collaboration revenues	2,055			16,592			4,058			18,345
Other product sales and royalties	138			326			437			427
Total revenues	19,649			31,012			37,529			46,492
Costs and expenses:
Cost of product sales	3,145			3,224			6,087			5,870
Research and development expenses	4,049			7,671			9,453			20,133
Selling, general and administrative expenses	15,211			15,101			29,216			28,282
Restructuring expenses	—			1,058			—			1,058
Total costs and expenses	22,405			27,054			44,756			55,343
Other income (expense):
Interest and dividend income, net	256			338			527			731
Gains on sale of assets	566			—			865			—
Gains (losses) on investments, net	26			(1,471		)	32			(1,471		)
Total other income (expense)	848			(1,133		)	1,424			(740		)
Net (loss) income before income taxes	(1,908		)	2,825			(5,803		)	(9,591		)
Income tax benefit	—			494			—			494

Net (loss) income	$	(1,908	)	$	3,319		$	(5,803	)	$	(9,097	)

Net (loss) income per share:
Basic	$	(0.09	)	$	0.16		$	(0.27	)	$	(0.43	)
Diluted	$	(0.09	)	$	0.15		$	(0.27	)	$	(0.43	)

Weighted average shares outstanding used to compute net (loss) income per share:
Basic	21,603			21,370			21,574			21,359
Diluted	21,603			21,649			21,574			21,359

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

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AMAG PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME

(IN THOUSANDS)

(Unaudited)

	Three Months Ended June 30,						Six Months Ended June 30,
	2013			2012			2013			2012

Net (loss) income	$	(1,908	)	$	3,319		$	(5,803	)	$	(9,097	)
Other comprehensive (loss) income :
Unrealized gains (losses) on securities:
Holding gains (losses) arising during period, net of tax	(612		)	(31		)	(709		)	46
Reclassification adjustment for (gains) losses included in net income (loss)	17			1,471			21			1,471
Net unrealized gains (losses) on securities	(595		)	1,440			(688		)	1,517
Total comprehensive (loss) income	$	(2,503	)	$	4,759		$	(6,491	)	$	(7,580	)

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

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AMAG PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(IN THOUSANDS)

(Unaudited)

	Six Months Ended June 30,
	2013			2012
Cash flows from operating activities:
Net loss	$	(5,803	)	$	(9,097	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	1,339			1,422
Amortization of premium/discount on purchased securities	1,369			1,463
Write-off of inventory	502			598
Non-cash equity-based compensation expense	4,221			3,262
Non-cash income tax benefit	—			(494		)
Gains on sale of assets	(865		)	—
(Gains) losses on investments, net	(32		)	1,471
Changes in operating assets and liabilities:
Accounts receivable, net	(2,080		)	154
Inventories	695			1,678
Receivable from collaboration	(105		)	(14,705		)
Prepaid and other current assets	555			2,086
Accounts payable and accrued expenses	(6,089		)	(6,546		)
Deferred revenues	(3,783		)	(3,048		)
Other long-term liabilities	(227		)	(199		)
Total adjustments	(4,500		)	(12,858		)
Net cash used in operating activities	(10,303		)	(21,955		)

Cash flows from investing activities:
Proceeds from sales or maturities of investments	63,767			85,234
Purchase of investments	(69,653		)	(96,178		)
Acquisition of MuGard Rights and inventory	(3,434		)	—
Proceeds from sale of assets	977			—
Change in restricted cash	(400		)
Capital expenditures	—			(47		)
Net cash used in investing activities	(8,743		)	(10,991		)

Cash flows from financing activities:
Proceeds from the exercise of stock options	379			—
Proceeds from the issuance of common stock under ESPP	176			150
Net cash provided by financing activities	555			150

Net decrease in cash and cash equivalents	(18,491		)	(32,796		)
Cash and cash equivalents at beginning of the period	46,293			63,474
Cash and cash equivalents at end of the period	$	27,802		$	30,678

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

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AMAG PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

JUNE 30, 2013

(Unaudited)

A. Description of Business

AMAG Pharmaceuticals, Inc., a Delaware corporation, was founded in 1981. We are a specialty pharmaceutical company that markets Feraheme ® (ferumoxytol) Injection for Intravenous, or IV, use to treat iron deficiency anemia, or IDA, and MuGard™ Mucoadhesive Oral Wound Rinse for the management of oral mucositis.

Currently, our principal source of revenue is from the sale of Feraheme , which was approved for marketing in the U.S. in June 2009 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 began selling Feraheme in the U.S. in July 2009 through our own commercial organization, including a specialty sales force. We sell Feraheme to authorized wholesalers and specialty distributors, who in turn, sell Feraheme to healthcare providers who administer Feraheme primarily within hospitals, hematology and oncology centers, and nephrology clinics.

Outside of the U.S., ferumoxytol has been granted marketing approval in Canada, Switzerland and the European Union, or EU, for use as an IV iron replacement therapy for the treatment of IDA in adult patients with CKD. The European marketing authorization is valid in the current EU member states as well as in Iceland and Norway. Under our amended agreement with Takeda Pharmaceutical Company Limited, or Takeda, Takeda has an exclusive license to market and sell ferumoxytol in Canada, the EU and Switzerland, as well as certain other geographic territories. In Canada, Takeda promotes ferumoxytol under the trade name Feraheme and in the EU and Switzerland, Takeda promotes ferumoxytol under the trade name Rienso ® 30mg/ml solution for Injection.

We are working to continue to grow Feraheme in the U.S. CKD market and to drive additional growth of Feraheme through both international and label expansion. In addition, to further build our business, we intend to continue to expand our portfolio through the in-license or purchase of additional commercialized specialty pharmaceutical products. In particular, we are seeking complementary products that will leverage our commercial infrastructure and focus on hematology and oncology centers, hospital infusion centers or other sites of care where IV iron is administered or where IDA patients are diagnosed or treated. We are also looking at the potential addition of products outside of our current sales force’s call points through increased referrals from certain physician specialists, such as gastroenterologists, which could be synergistic with the potential label expansion of Feraheme , if regulatory approval is obtained.

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Rights. In addition, Access has assigned us all of its right, title and interest in MuGard -related internet and social media outlets and other sales, marketing and promotional materials currently owned or controlled by Access, because, pursuant to the Access License Agreement, Access will no longer commercialize, market, promote, sell or make public communications relating to MuGard in the U.S Territory, except as may be agreed to by us. We sell MuGard to wholesalers and specialty and retail pharmacies. Additional details regarding the Access License Agreement and the MuGard Rights can be found in Note G.

We are subject to risks common to companies in the pharmaceutical industry including, but not limited to, our primary dependence on the success of Feraheme/Rienso , uncertainties related to the protection of our proprietary technology related to Feraheme , our dependence on third parties to manufacture Feraheme/Rienso and MuGard , the potential development of significant safety or drug interaction problems with respect to Feraheme/Rienso , uncertainty of the regulatory approval process for the broader Feraheme/Rienso indication or for potential alternative manufacturing facilities and processes, uncertainties related to potential collaborations, in-licensing arrangements or acquisition agreements, competition in our industry, uncertainties regarding market acceptance of Feraheme/Rienso or MuGard , our reliance on a limited number of customers for Feraheme , uncertainties related to patient insurance coverage and third-party reimbursement rates and terms for Feraheme/Rienso or MuGard , our reliance on Takeda to commercialize Feraheme/Rienso in certain territories outside of the U.S., the potential inability of our or Access’ third-party manufacturers to operate their facilities in compliance with current good manufacturing practices and manufacture sufficient quantities of Feraheme/Rienso or MuGard , uncertainties related to the impact of current and future healthcare initiatives and legislation, our third-party manufacturers, or Access’ potential inability to obtain raw or other materials, our potential inadvertent failure to comply with reporting and payment obligations under government pricing programs, our potential inability to become profitable in the future, our limited experience commercializing and distributing a pharmaceutical product, our dependence on key personnel, 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, our potential inadvertent failure to comply with the regulations of the FDA or other federal, state or foreign government agencies, the volatility of our stock price, uncertainties related to the actions of activist stockholders, potential product liability, potential legislative and regulatory changes, and potential costs and liabilities associated with pending or future litigation or patent challenges.

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.”

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. Beginning on June 6, 2013, the date we acquired the MuGard Rights, our financial statements include the assets, liabilities, operating results and cash flows related to those rights.

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

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Statements in our Annual Report on Form 10-K for the year ended December 31, 2012. 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, 2012.

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 related to product sales and collaboration agreements, product sales allowances and accruals, assessing investments for potential other-than-temporary impairment and determining values of investments, the fair value of our assets held for sale, contingent consideration, the impairment of long-lived assets, including intangible assets, 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 Europe Limited and AMAG Securities Corporation. AMAG Europe Limited was incorporated in October 2009 in London, England. AMAG Securities Corporation is a Massachusetts corporation which was incorporated in August 2007. All intercompany account balances and transactions between the companies have been eliminated.

Fair Value Measurements

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.

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 third 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 and liabilities that are required to be measured at fair value on a recurring basis, including our cash equivalents, investments, and contingent consideration. The following tables represent the fair value hierarchy as of June 30, 2013 and December 31, 2012 for those assets and liabilities that we measure at fair value on a recurring basis (in thousands):

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	Fair Value Measurements at June 30, 2013 Using:
			Quoted Prices in Active Markets for Identical Assets		Significant Other Observable Inputs		Significant Unobservable Inputs
	Total		(Level 1)		(Level 2)		(Level 3)
Assets:
Money market funds	$	19,934	$	19,934	$	—	$	—
Corporate debt securities	127,419		—		127,419		—
U.S. treasury and government agency securities	54,691		—		54,691		—
Commercial paper	2,501		—		2,501		—
Liabilities:
Acquisition-related contingent consideration	14,000		—		—		14,000
	$	218,545	$	19,934	$	184,611	$	14,000

	Fair Value Measurements at December 31, 2012 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	$	24,058	$	24,058	$	—	$	—
Corporate debt securities	111,690		—		111,690		—
U.S. treasury and government agency securities	59,569		—		59,569		—
Commercial paper	9,491		—		9,491		—
	$	204,808	$	24,058	$	180,750	$	—

With the exception of our money market funds and our acquisition-related contingent consideration, the fair value of our investments is primarily determined from independent pricing services which use Level 2 inputs to determine fair value. Independent pricing services normally derive security prices from recently reported trades for identical or similar securities, making adjustments based upon other significant observable market transactions. At the end of each reporting period, we perform quantitative and qualitative analyses of 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 either June 30, 2013 or December 31, 2012. In addition, there were no transfers or reclassifications of any securities between Level 1 and Level 2 during the three months ended June 30, 2013.

We are accounting for the acquisition of the MuGard Rights as a business combination under the acquisition method of accounting. Additional details regarding the Access License Agreement and the MuGard Rights can be found in Note G. The fair value measurements of contingent consideration obligations and the related intangible asset arising from business combinations is determined using unobservable, or Level 3, inputs. These inputs include (i) the estimated amount and timing of projected cash flows; (ii) the probability of the achievement of the factors on which the contingency is based; and (iii) the risk-adjusted discount rate used to present value the probability-weighted cash flows. Significant increases (decreases) in any of those inputs in isolation could result in a significantly lower (higher) fair value measurement.

The following table presents a reconciliation of contingent consideration obligations related to our acquisition of the MuGard Rights measured on recurring basis using Level 3 inputs for the three and six months ended June 30, 2013 (in thousands):

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	Three Months Ended June 30, 2013		Six Months Ended June 30, 2013
Balance at beginning of period	$	—	$	—
Acquisition-date fair value of contingent consideration	14,000		14,000
Balance at end of period	$	14,000	$	14,000

The fair value of the contingent consideration was determined to be $14.0 million as of June 6, 2013, or the Acquisition Date. As of June 30, 2013, we estimate that the undiscounted royalty amounts we could pay under the Access License Agreement may range from $28.0 million to $34.0 million over a ten year period, which is our best estimate of the period over which we expect the majority of the asset’s cash flows to be derived. This measure is based on significant Level 3 inputs not observable in the market. Key assumptions include a discount rate of 15%. As of June 30, 2013, the assumptions used for determining fair value of the contingent consideration have not changed significantly from those used at the Acquisition Date.

In addition, we measure our intangible assets, which currently consist of $17.2 million related to the acquisition of the MuGard Rights, on a non-recurring basis. This measurement is based on significant Level 3 inputs not observable in the market. Key assumptions include a discount rate of 19%. We believe the fair values assigned to the MuGard Rights are based on reasonable assumptions, however, we cannot provide assurance that the underlying assumptions used to forecast the cash flows will materialize as we estimated and thus, our actual results may vary significantly from the estimated results. Intangible assets are reviewed for impairment at least annually and whenever facts or circumstances suggest that the carrying value of these assets may not be recoverable. Our policy is to identify and record impairment losses, if necessary, on intangible assets when events and circumstances indicate that the assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amounts of those assets.

Assets Held for Sale

During 2012, we determined that certain assets related to our Cambridge, Massachusetts manufacturing facility, including the related land, building and certain equipment, met the criteria established by current accounting guidance for classifying assets as held for sale. As a result, during 2012, we reclassified these assets from property and equipment to assets held for sale in our condensed consolidated balance sheet. In anticipation of a future sale, we valued these assets at the lower of their carrying amount or fair value less cost to sell to arrive at the estimated fair value of $2.0 million as of December 31, 2012. During the first half of 2013, we sold $0.5 million of equipment related to our Cambridge, Massachusetts manufacturing facility. In connection with these sales, we recorded a gain of $0.4 million during the six months ended June 30, 2013 and reduced the carrying value of our assets held for sale by $0.1 million to $1.9 million at June 30, 2013. The fair values of the land, building, and equipment were estimated using Level 3 inputs, which included offers received from potential purchasers, real estate appraisals and other estimates from third-parties.

Revenue Recognition and Related Sales Allowances and Accruals

An analysis of our product sales allowances and accruals for the three and six months ended June 30, 2013 and 2012 is as follows (in thousands):

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	Three Months Ended June 30,
	2013			2012
Provision for U.S. Feraheme sales allowances and accruals
Discounts and chargebacks	$	9,227		$	6,846
Government and other rebates	2,732			1,672
Returns	239			(292		)
Total provision for U.S. Feraheme sales allowances and accruals	$	12,198		$	8,226

Total gross U.S. Feraheme sales	$	29,654		$	22,320

Total provision for U.S. Feraheme sales allowances and accruals as a percent of total gross U.S. Feraheme sales	41		%	37		%

	Six Months Ended June 30,
	2013			2012
Provision for U.S. Feraheme sales allowances and accruals
Discounts and chargebacks	$	16,720		$	12,738
Government and other rebates	5,119			3,132
Returns	432			(558		)
Total provision for U.S. Feraheme sales allowances and accruals	$	22,271		$	15,312

Total gross U.S. Feraheme sales	$	55,305		$	43,032

Total provision for U.S. Feraheme sales allowances and accruals as a percent of total gross U.S. Feraheme sales	40		%	36		%

We generally offer our wholesalers, specialty distributors and other customers a limited right to return Feraheme purchased directly from us, principally based on the product’s expiration date which, once packaged, is currently five years in the U.S. Reserves for Feraheme returns for U.S. sales are recorded in the period the related revenue is recognized, resulting in a reduction to product sales. We evaluate our estimated product returns rate each period based on the historical return patterns and known or expected changes in the marketplace. We did not significantly adjust our reserve for product returns during the six months ended June 30, 2013. During the six months ended June 30, 2012, we reduced our reserve by approximately $1.1 million of previously reserved Feraheme returns allowance due to the lapse of the product return period on certain manufactured Feraheme lots that carried a two year expiration period. The product returns provision applied to gross product sales for the six months ended June 30, 2013 was $0.4 million as compared to a credit of $0.6 million for the six months ended June 30, 2012.

In addition, as part of our sales allowances and accruals, we reserve for estimated Medicaid rebates associated with instances where Medicaid will act as the insurer and for which we are required to pay a statutory rebate to Medicaid. We regularly assess our Medicaid reserve balance and the rate at which we accrue for claims against product sales. If we determine in future periods that our actual rebate experience is not indicative of expected claims, if our actual claims experience changes, or if other factors affect estimated claims rates, we may be required to adjust our current Medicaid accumulated reserve estimate, which would affect our earnings in the period of the adjustment and could be significant. For example, we currently have $0.5 million included in our Medicaid reserve balance related to sales of Feraheme from 2009 to 2011. As a result, if we determine that this reserve is in excess of actual claims experience, we will be required to release all or a portion of the reserve to our condensed consolidated statement of operations.

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Acquisitions

We account for acquired businesses using the acquisition method of accounting, which requires, with limited exceptions, that assets acquired and liabilities assumed be recognized at their estimated fair values as of the acquisition date. Transaction costs are expensed as incurred. Any excess of the consideration transferred over the assigned values of the net assets acquired is recorded as goodwill.

Intangible Assets

Intangible assets with definite useful lives are amortized to their estimated residual values over their estimated useful lives and reviewed for impairment if certain events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. We have estimated the fair value of the intangible asset related to the acquisition of the MuGard Rights to be $17.2 million as of the date of the acquisition.

Contingent Consideration

Contingent consideration arising from a business combination is included as part of the acquisition cost and is recognized at fair value as of the acquisition date. Any liability resulting from contingent consideration is remeasured to fair value at each reporting date until the contingency is resolved. These changes in fair value are recognized in our condensed consolidated statements of operations. We have estimated the fair value of the contingent consideration related to the acquisition of the MuGard Rights to be $14.0 million as of the date of the acquisition.

Concentrations and Significant Customer Information

Financial instruments which potentially subject us to concentrations of credit risk consist principally of cash, investments, and accounts receivable. As of June 30, 2013, our cash, cash equivalents and investments amounted to approximately $212.4 million. We currently invest our excess cash primarily in U.S. government and agency money market funds, and investments in corporate debt securities, U.S. treasury and government agency securities and commercial paper. As of June 30, 2013, we had approximately $19.9 million of our total $27.8 million cash and cash equivalents balance invested in institutional money market funds, of which $12.3 million was invested in a single fund, which is collateralized solely by U.S. treasury and government agency securities.

Our operations are located solely within the U.S. We are focused principally on developing, manufacturing, and commercializing Feraheme/Rienso and commercializing MuGard . 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 total revenues for the six months ended June 30, 2013 and 2012:

	Six Months Ended June 30,
	2013		2012
AmerisourceBergen Drug Corporation	43	%	30	%
McKesson Corporation	23	%	14	%
Cardinal Health, Inc.	15	%	10	%
Takeda Pharmaceuticals Company Limited	11	%	40	%

In addition, approximately 33% and 32% of our end-user demand during the six months ended June 30, 2013 and 2012, respectively, was generated by members of a single group purchasing organization with which we have contracted. Revenues from customers outside of the U.S. amounted to approximately 12% and 40% of our total revenues for the six months ended June 30, 2013 and 2012, respectively, and were

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primarily related to collaboration revenue recognized in connection with our collaboration agreement with Takeda, which is based in Japan.

We are currently solely dependent on a single supply chain for our Feraheme/Rienso drug substance and finished drug product. We are exposed to a significant loss of revenue from the sale of Feraheme/Rienso if our suppliers and/or manufacturers cannot fulfill demand for any reason.

C. Investments

As of June 30, 2013 and December 31, 2012, our investments equaled $184.6 million and $180.8 million, respectively, and consisted of securities classified as 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 investments as of June 30, 2013 and December 31, 2012 (in thousands):

	June 30, 2013
			Gross		Gross			Estimated
	Amortized		Unrealized		Unrealized			Fair
	Cost		Gains		Losses			Value
Corporate debt securities
Due in one year or less	$	54,636	$	76	$	(12	)	$	54,700
Due in one to three years	73,115		35		(431		)	72,719
U.S. treasury and government agency securities
Due in one year or less	24,683		32		(2		)	24,713
Due in one to three years	30,018		42		(82		)	29,978
Commercial paper
Due in one year or less	2,500		1		—			2,501
Total investments	$	184,952	$	186	$	(527	)	$	184,611

	December 31, 2012
			Gross		Gross			Estimated
	Amortized		Unrealized		Unrealized			Fair
	Cost		Gains		Losses			Value
Corporate debt securities
Due in one year or less	$	52,332	$	88	$	(6	)	$	52,414
Due in one to three years	59,176		137		(37		)	59,276
U.S. treasury and government agency securities
Due in one year or less	24,795		86		—			24,881
Due in one to three years	34,606		84		(2		)	34,688
Commercial paper
Due in one year or less	9,494		1		(4		)	9,491
Total investments	$	180,403	$	396	$	(49	)	$	180,750

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Impairments and Unrealized Losses on Investments

We did not recognize any unrealized other-than-temporary impairment losses in our condensed consolidated statements of operations related to our securities during any of the three or six months ended June 30, 2013 and 2012. 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 entire 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 on Investments

Gains and losses are determined on the specific identification method. Realized gains were insignificant during both the three and six months ended June 30, 2013. During both the three and six months ended June 30, 2012 we recorded realized losses of $1.5 million to our condensed consolidated statements of operations related to the sale of our then-remaining auction rate securities portfolio.

D. Accounts Receivable, Net

Our net accounts receivable were $8.5 million and $6.4 million as of June 30, 2013 and December 31, 2012, respectively, and primarily represented amounts due from wholesalers and distributors to whom we sell Feraheme directly. 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 sheets.

Customers which represented greater than 10% of our accounts receivable balances as of June 30, 2013 and December 31, 2012 were as follows:

	June 30, 2013		December 31, 2012
AmerisourceBergen Drug Corporation	49	%	48	%
McKesson Corporation	25	%	28	%
Cardinal Health, Inc.	18	%	18	%

E. Inventories

Our major classes of inventories were as follows as of June 30, 2013 and December 31, 2012 (in thousands):

	June 30, 2013		December 31, 2012
Raw materials	$	4,735	$	2,652
Work in process	2,876		2,524
Finished goods	5,863		7,275
Total inventories	$	13,474	$	12,451

In May 2013, Takeda recalled one specific batch of Rienso from the Swiss market. The batch was only distributed to and sold in Switzerland and the recall was limited to the specific batch and specifically in Switzerland. During the three months ended June 30, 2013, we expensed $0.5 million of inventory related to this batch of Rienso which we no longer believed was suitable for sale and which was the subject of the voluntary recall by Takeda in the Swiss market.

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In connection with the Access License Agreement, we purchased the entire MuGard inventory held by Access, at cost. As of June 30, 2013, we recorded $0.2 million of MuGard inventory, which represented its full fair value in our condensed consolidated balance sheet.

F. Property and Equipment, Net

Property and equipment consisted of the following as of June 30, 2013 and December 31, 2012, respectively (in thousands):

	June 30, 2013			December 31, 2012
Buildings and improvements	$	5,138		$	5,373
Laboratory and production equipment	343			115
Furniture and fixtures	4,963			5,326
Construction in process	—			228
	10,444			11,042
Less - accumulated depreciation	(8,531		)	(7,745		)
Property and equipment, net	$	1,913		$	3,297

During the six months ended June 30, 2013, we recorded $1.3 million of depreciation expense. This included accelerated depreciation expense of approximately $0.4 million of leasehold improvements and furniture and fixtures associated with a portion of our principal executive offices to reflect our current estimate of useful lives of these assets.

G. Business Combinations

As part of our strategy to expand our portfolio with additional commercial-stage specialty products, on June 6, 2013, we entered into the Access License Agreement pursuant to which Access granted us an exclusive, royalty-bearing license, with the right to grant sublicenses, to certain intellectual property rights, including know-how, patents and trademarks, to use, import, offer for sale, sell, manufacture and commercialize MuGard in the U.S. Territory for the management of all diseases or conditions of the oropharyngeal cavity, including mucositis.

Access is a company that develops and commercializes proprietary pharmaceutical products for the treatment and supportive care of cancer patients. MuGard was launched by Access in 2010 after receiving 510(k) clearance from the FDA. It is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces.

Access will continue to manufacture MuGard and we have agreed to enter into separate quality and supply agreements with Access under which we will purchase MuGard inventory from Access. Our inventory purchases will be at the price actually paid by Access to purchase it from a third-party plus a mark-up to cover administration, handling and overhead.

In consideration for the license, we paid Access an upfront payment of $3.3 million in June 2013. We will also pay Access royalties on future net sales of MuGard until the later of (i) the expiration of the licensed patents or (ii) the tenth anniversary of the first commercial sale of MuGard under the Access License Agreement in the U.S. Territory, or the Royalty Term. These tiered, double-digit royalty rates decrease for any part of the Royalty Term occurring after the expiration of the licensed patents and are subject to off-set against certain of our expenses. After the expiration of the Royalty Term, the license

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shall become a fully paid-up, royalty-free and perpetual license in the U.S. Territory. In addition to the $3.3 million upfront payment we also acquired $0.2 million of MuGard inventory from Access, which we have included in our condensed consolidated balance sheet.

We did not assume any pre-existing liabilities related to the MuGard business, contingent or otherwise, arising prior to the Acquisition Date. We are accounting for the acquisition of the MuGard Rights as a business combination under the acquisition method of accounting since we acquired the U.S. commercial rights for MuGard and inventory, and obtained access to certain related regulatory assets, employees and other assets, including certain patent and trademark rights, contracts, and related books and records, held by Access which are exclusively related to MuGard (inputs), including the infrastructure to sell, distribute and market MuGard (processes) and net sales of MuGard (outputs). In addition, during the term of the Access License Agreement, we will have control over sales, distribution and marketing of MuGard in the U.S. as Access has assigned to us all of its right, title and interest in MuGard -related internet and social media outlets and other sales, marketing and promotional materials currently owned or controlled by Access. Access will no longer commercialize, market, promote, sell or make public communications relating to MuGard in the U.S Territory, except as may be agreed to by us. Access has also agreed to not, directly or indirectly, research, develop, market, sell or commercialize any medical devices that directly compete with MuGard for the treatment of any diseases or conditions of the oropharyngeal cavity in the U.S. Territory.

We estimated the fair value of the acquired MuGard Rights using the income approach. The income approach uses valuation techniques to convert future amounts to a single present amount (discounted). This approach begins with a forecast of the net cash flows expected to be generated by the asset over its estimated useful life. These cash flows are then adjusted to present value by applying an appropriate discount rate that reflects the risk factors associated with the cash flow streams. Some of the more significant estimates and assumptions inherent in the income approach include the following:

· The amount and timing of projected future cash flows, adjusted for the probability of marketing success;

· The discount rate selected to measure the risks inherent in the future cash flows; and

· An assessment of the asset’s life-cycle and the competitive trends impacting the asset.

The following table summarizes the total consideration for the MuGard Rights (in thousands):

Consideration:
Cash	$	3,434
Acquisition-related contingent consideration	14,000
Total consideration	$	17,434

The $17.4 million total consideration includes the estimated fair value of the contingent consideration. The Acquisition Date fair value of the contingent consideration was determined based on various market factors, including an analysis of estimated sales using a discount rate of 15%. As of June 30, 2013, we estimated that the undiscounted royalty amounts we could pay under the Access License Agreement may range from $28.0 million to $34.0 million over a ten year period, which is our best estimate of the period over which we expect the majority of the asset’s cash flows to be derived. This measure is based on significant Level 3 inputs not observable in the market. There were no changes in the estimated fair value of the contingent liability for the three and six months ended June 30, 2013. We have classified $1.0 million of the contingent consideration as a short-term liability, which was included in accrued expenses in our condensed consolidated balance sheet as of June 30, 2013.

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The following table summarizes the estimated fair values of the assets acquired related to the business combination as of the Acquisition Date (in thousands):

Assets Acquired:
MuGard intangible asset	$	17,193
Inventory	241
Net identifiable assets acquired	$	17,434

The Acquisition Date fair value of the intangible asset was determined based on various market factors, including an analysis of estimated sales using a discount rate of 19%. This measure is based on significant Level 3 inputs not observable in the market. There were no changes in the estimated fair value of the intangible asset for the three and six months ended June 30, 2013.

Commencing from the Acquisition Date, our condensed consolidated financial statements include the assets, liabilities, operating results and cash flows from the acquired product. As a result, our condensed consolidated financial statements for the quarter ended June 30, 2013 reflect less than a month of MuGard activity. Revenues related to MuGard sales for the three months ended June 30, 2013 were not material.

Transaction costs are not included as a component of consideration transferred and are expensed as incurred. We incurred approximately $0.8 million of acquisition-related costs during the three months ended June 30, 2013. These costs were primarily related to legal and professional fees and are included in selling, general and administrative expenses in our condensed consolidated statements of operations for the three and six months ended June 30, 2013.

Pro forma results of operations would not be materially different as a result of the acquisition of the MuGard Rights and therefore are not presented.

H. Intangible Assets, Net

On June 6, 2013, we acquired the MuGard Rights from Access and recorded $17.2 million to finite-lived intangible assets based on the estimated fair value of the MuGard Rights as of the Acquisition Date. Such valuations require significant estimates and assumptions including but not limited to: estimating future cash flows from product sales and developing appropriate discount and probability rates. We believe the fair values assigned to the MuGard Rights are based on reasonable assumptions, however, we cannot provide assurance that the underlying assumptions used to forecast the cash flows will materialize as we estimated and thus, our actual results may vary significantly from the estimated results.

We will amortize the MuGard Rights using an economic consumption model over ten years, which represents our best estimate of the period over which we expect the majority of the asset’s cash flows to be derived. We believe this is the best approximation of the period over which we will derive the majority of value of the MuGard Rights. We recorded an insignificant amount of amortization related to the MuGard Rights in cost of product sales in our condensed consolidated statements of operations for each of the three and six months ended June 30, 2013.

Intangible assets are reviewed for impairment at least annually and whenever facts or circumstances suggest that the carrying value of these assets may not be recoverable. Our policy is to identify and record impairment losses, if necessary, on intangible assets when events and circumstances indicate that the assets might be impaired and the undiscounted cash flows estimated to be generated by those assets are less than the carrying amounts of those assets.

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We expect future annual amortization expense related to our intangible asset to be as follows (in thousands):

Period	Estimated Amortization Expense

Year Ended December 31, 2013	$	254
Year Ended December 31, 2014	659
Year Ended December 31, 2015	913
Year Ended December 31, 2016	1,213
Year Ended December 31, 2017	1,613
Year Ended December 31, 2018	2,100
Thereafter	10,440
Total	$	17,192

I. 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 and six months ended June 30, 2013, we did not recognize any tax expense or benefit due to our continued net operating loss position. For the three and six months ended June 30, 2012, we recognized a $0.5 million current federal income tax benefit, which was primarily the result of a decrease in unrealized losses associated with the sale of our then-remaining auction rate securities portfolio in June 2012. Due to the uncertainty surrounding the realization of favorable tax attributes in future tax returns, we have recorded a full valuation allowance against our otherwise recognizable net deferred tax assets.

J. Accumulated Other Comprehensive Loss

In February 2013, the Financial Accounting Standards Board issued an amendment to the accounting guidance for the reporting of amounts reclassified out of accumulated other comprehensive loss, or AOCI. The amendment expands the existing disclosure by requiring entities to present information about significant items reclassified out of AOCI by component. In addition, an entity is required to provide information about the effects on net income of significant amounts reclassified out of each component of AOCI to net income either on the face of the income statement or as a separate disclosure in the notes of the financial statements. The amendment is effective for annual or interim reporting periods beginning after December 31, 2012. The adoption of this accounting pronouncement did not have a material impact on our financial statement disclosures.

The changes in AOCI, net of tax, for the three and six months ended June 30, 2013 consisted of the following (in thousands):

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	Three Months Ended June 30, 2013			Six Months Ended June 30, 2013

Beginning Balance	$	(3,340	)	$	(3,247	)
Other comprehensive income (loss) before reclassifications	(622		)	(709		)
Gain (loss) reclassified from other accumulated comprehensive loss	27			21
Ending Balance	$	(3,935	)	$	(3,935	)

The amounts reclassified from other comprehensive loss for the six months ended June 30, 2013 primarily represented realized gains on investments, which are included in our condensed consolidated statement of operations under “Gains (losses) on investments, net.” The amounts reclassified from other comprehensive loss for the six months ended June 30, 2012, primarily represented realized losses on the sale of our then-remaining auction rate securities.

K. Net (Loss) Income per Share

We compute basic net (loss) income per share by dividing net (loss) income by the weighted average number of common shares outstanding during the relevant period. The components of basic and diluted net (loss) income per share were as follows (in thousands, except per share data):

	Three Months Ended June 30,					Six Months Ended June 30,
	2013			2012		2013			2012
Net (loss) income	$	(1,908	)	$	3,319	$	(5,803	)	$	(9,097	)
Weighted average common shares outstanding	21,603			21,370		21,574			21,359
Effect of dilutive securities:
Stock options and restricted stock units	—			279		—			—
Shares used in calculating dilutive net (loss) income per share	21,603			21,649		21,574			21,359

Net (loss) income per share:
Basic	$	(0.09	)	$	0.16	$	(0.27	)	$	(0.43	)
Diluted	$	(0.09	)	$	0.15	$	(0.27	)	$	(0.43	)

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), that were excluded from our computation of diluted net (loss) income per share because such options and restricted stock units were anti-dilutive (in thousands):

	Three Months Ended June 30,		Six Months Ended June 30,
	2013	2012	2013	2012
Options to purchase shares of common stock	2,763	3,044	2,763	2,873
Shares of common stock issuable upon the vesting of restricted stock units	491	142	491	484
Total	3,254	3,186	3,254	3,357

L. Equity-Based Compensation

We currently maintain two equity compensation plans, including our Third Amended and Restated 2007 Equity Incentive Plan, or the 2007 Plan, and our Amended and Restated 2000 Stock Plan, or the 2000 Plan.

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Third Amended and Restated 2007 Equity Incentive Plan

Our 2007 Plan was originally approved by our stockholders in November 2007. In each of May 2009, May 2010 and May 2013, our stockholders approved proposals to amend and restate our 2007 Plan to, among other things, increase the number of shares authorized for issuance thereunder by 600,000, 800,000 and 1,100,000 shares, respectively.

As of June 30, 2013, we have granted options and restricted stock units covering 6,142,775 shares of common stock under our 2007 Plan, of which 2,466,736 stock options and 621,313 restricted stock units have expired or terminated, and of which 56,524 options have been exercised and 423,822 shares of common stock have been issued pursuant to restricted stock units that became fully vested. The number of options and restricted stock units outstanding under this plan as of June 30, 2013 was 2,228,884 and 345,496, respectively. The remaining number of shares available for future grants as of June 30, 2013 was 2,075,954, 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 stock options granted under our 2007 Plan have an exercise price equal to the closing price of a share of our common stock on the grant date and have either a seven or ten-year term.

Amended and Restated 2000 Stock Plan

As of June 30, 2013, the number of shares underlying outstanding options which were issued pursuant to our 2000 Plan was 109,491. There were no restricted stock units outstanding as of June 30, 2013. 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.

Other Equity Compensation Grants

In June 2013, to induce him to accept employment with us and as provided in his employment agreement, our Board of Directors, or Board, granted our Chief Development and Regulatory Affairs Officer an option to purchase 60,000 shares of our common stock at an exercise price equal to the fair market value of a share of our common stock on the date of grant. The option will be exercisable in four equal annual installments beginning on the first anniversary of the grant date. Our Chief Development and Regulatory Affairs Officer was also granted 35,000 restricted stock units to induce him to accept employment with us, as provided in his employment agreement, which will vest in four equal annual installments beginning on the first anniversary of the grant date. The foregoing grants were made pursuant to an inducement grant outside of our 2007 Plan as permitted under the NASDAQ Global Market rules. We assessed the terms of these awards and determined there was no possibility that we would have to settle these awards in cash and therefore, equity accounting was applied.

In February 2013, we granted restricted stock units to certain members of our senior management covering a maximum of 82,500 shares of common stock, which are subject to a performance condition tied to the price of our common stock. These restricted stock units vest, if at all, at the end of the three-year period ending December 31, 2015 based on the achievement of a minimum, target or maximum stock price range. In the event that the minimum stock price range is not achieved at the measurement date, none of the restricted stock units will vest. The maximum total fair value of these restricted stock

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units is $0.7 million, which we are recognizing to expense over a period of three years from the date of grant, net of any estimated and actual forfeitures.

In January 2013, to induce him to accept employment with us and as provided in his employment agreement, our Board granted our Chief Commercial Officer, an option to purchase 75,000 shares of our common stock at an exercise price equal to the fair market value of a share of our common stock on the date of grant. The option will be exercisable in four equal annual installments beginning on the first anniversary of the grant date. Our Chief Commercial Officer was also granted 35,000 restricted stock units to induce him to accept employment with us, as provided in his employment agreement, which will vest in four equal annual installments beginning on the first anniversary of the grant date. The foregoing grants were made pursuant to an inducement grant outside of our 2007 Plan as permitted under the NASDAQ Global Market rules. We assessed the terms of these awards and determined there was no possibility that we would have to settle these awards in cash and therefore, equity accounting was applied.

Equity-based compensation expense

Equity-based compensation expense, for the three and six months ended June 30, 2013 and 2012 consisted of the following (in thousands):

	Three Months Ended June 30,				Six Months Ended June 30,
	2013		2012		2013		2012
Cost of product sales	$	35	$	68	$	58	$	146
Research and development	365		525		1,297		947
Selling, general and administrative	1,539		984		2,866		2,169
Total equity-based compensation expense	$	1,939	$	1,577	$	4,221	$	3,262

We reduce the equity-based compensation expense being recognized to account for estimated forfeitures, which we estimate based primarily on historical experience, adjusted for unusual events such as our corporate restructuring in 2012, which resulted in higher than expected turnover and forfeitures in that year. Under current accounting guidance, forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

M. Commitments and Contingencies

Facility Lease Obligations

On June 10, 2013, we entered into a lease agreement with BP Bay Colony LLC, or the Landlord, for the lease of certain real property located at 1100 Winter Street, Waltham, Massachusetts, or the Premises, for use as our principal executive offices. The Landlord has agreed to build out the Premises, which is expected to be completed in September 2013. The initial term of the lease is five years and two months with one five-year extension term at our option. During the extension period, the base rent will be an amount agreed upon by us and the Landlord. In addition to base rent, we are also required to pay a proportionate share of the Landlord’s operating costs. The lease requires us to pay base rent during the initial term as follows:

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Period	Minimum Lease Payments

Year Ended December 31, 2013	$	128,734
Year Ended December 31, 2014	1,127,595
Year Ended December 31, 2015	1,127,595
Year Ended December 31, 2016	1,127,595
Year Ended December 31, 2017	1,127,595
Thereafter	1,033,629
Total	$	5,672,743

The Landlord has agreed to pay for certain agreed-upon improvements and we will pay for any increased costs due to changes by us in the agreed-upon plans. We will record all tenant improvements paid by us as leasehold improvements and will amortize these improvements over the shorter of the estimated useful life of the improvement or the remaining life of the initial lease term. Amortization of leasehold improvements is included in depreciation expense.

In addition, in connection with our new facility lease, in June 2013 we delivered to the Landlord a security deposit of approximately $0.4 million in the form of an irrevocable letter of credit. This security deposit will be reduced to $0.3 million on the second anniversary of the Commencement Date. The cash securing this letter of credit is classified on our balance sheet as a long-term asset and is restricted in its use.

On June 10, 2013 , we also entered into an Assignment and Assumption of Lease, or the Assignment Agreement, with Shire Human Genetic Therapies, Inc., or Shire, effecting the assignment to Shire of the right to occupy our current office space located at 100 Hayden Avenue, Lexington, Massachusetts, or the Current Space. Under the Assignment Agreement, the assignment to Shire will be effective on the later of September 1, 2013 or the date of our departure from the Current Space, and Shire will assume all of our obligations as the tenant of the Current Space. The Assignment Agreement also provides for the conveyance of furniture and other personal property by us to Shire. As a result, we anticipate that our lease obligations will decrease by an aggregate of approximately $3.2 million through August 31, 2016, the date on which the lease on our Current Space is set to expire.

Legal Proceedings

We accrue a liability for legal contingencies when we believe that it is both probable that a liability has been incurred and that we can reasonably estimate the amount of the loss. We review these accruals and adjust them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel and other relevant information. To the extent new information is obtained and our views on the probable outcomes of claims, suits, assessments, investigations or legal proceedings change, changes in our accrued liabilities would be recorded in the period in which such determination is made. For the matters referenced below, the liability is not probable or the amount cannot be reasonably estimated and, therefore, accruals have not been made. In addition, in accordance with the relevant authoritative guidance, for any matters in which the likelihood of material loss is at least reasonably possible, we will provide disclosure of the possible loss or range of loss. If a reasonable estimate cannot be made, however, we will provide disclosure to that effect.

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former President and Chief Executive Officer, former Chief Financial Officer, the then-members of our Board, and certain underwriters in our January 2010 offering of common stock violated certain federal securities laws, specifically Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended, and that our former President and Chief Executive Officer and former Chief Financial Officer violated Section 15 of such Act, respectively, by making certain alleged false and misleading statements and omissions in a registration statement filed in January 2010. The plaintiffs sought 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. On August 11, 2011, the District Court issued an Opinion and Order dismissing the SAC in its entirety for failure to state a claim upon which relief could be granted. A separate Order of Dismissal was filed on August 15, 2011. On September 14, 2011, the plaintiffs filed a Notice of Appeal to the U.S. Court of Appeals for the First Circuit, or the Court of Appeals. After briefing was completed by all parties, the Court of Appeals heard oral argument on May 11, 2012. On February 4, 2013, the Court of Appeals affirmed in part and reversed in part the District Court’s Opinion and Order, and remanded the case to the District Court. On February 19, 2013, we filed a Petition for Panel Hearing Rehearing or Rehearing En Banc , asking the Court of Appeals to reconsider its decision. On March 15, 2013, the Court of Appeals denied this petition. On March 22, 2013, we filed a Motion to Stay the Mandate remanding the case to the District Court pending review of the Court of Appeals’ February 4, 2013 decision by the U.S. Supreme Court. The Court of Appeals granted this Motion to Stay the Mandate on April 8, 2013. On June 13, 2013, we filed an appeal to the U.S. Supreme Court, or a writ of certiorari , seeking review of the First Circuit’s decision and to have that decision overturned. The plaintiffs have until August 16, 2013 to file their response. We are currently unable to predict the outcome or reasonably estimate the range of potential loss associated with this matter, if any, and have therefore not recorded any potential estimated liability as we do not believe that such a liability is probable nor do we believe that a range of loss is currently estimable.

In July 2010, Sandoz GmbH, or Sandoz, filed with the European Patent Office, or the EPO, an opposition to our previously issued patent which covers ferumoxytol in the EU. In October 2012, at an oral hearing, the Opposition Division of the EPO revoked our European ferumoxytol patent. In December 2012, our notice of appeal was recorded with the EPO, which suspended the revocation of our patent. We will continue to defend the validity of this patent throughout the appeals process, which we expect to take two to three years. However, in the event that we do not experience a successful outcome from the appeals process, under EU regulations ferumoxytol would still be entitled to eight years of data protection and ten years of market exclusivity from the date of approval, which we believe would create barriers to entry for any generic version of ferumoxytol into the EU market until sometime between 2020 and 2022. This decision had no impact on our revenues for the six months ended June 30, 2013. However, any future unfavorable outcome in this matter could negatively affect the magnitude and timing of future revenues, including royalties and milestone payments we may receive from Takeda pursuant to our collaboration agreement with Takeda. We do not expect to incur any related liability regardless of the outcome of the appeal and therefore have not recorded any liability as of June 30, 2013. We continue to believe the patent is valid and intend to vigorously appeal the decision.

We may periodically become subject to other legal proceedings and claims arising in connection with ongoing business activities, including claims or disputes related to product liability matters or related to patents that have been issued or that are pending in the field of research on which we are focused. Other than the above actions, we are not aware of any material claims against us as of June 30, 2013. We expense legal costs as they are incurred.

Acquisition-related Contingent Consideration

In connection with the acquisition of the MuGard Rights, we have agreed to pay Access royalties on future sales of MuGard . We have estimated the fair value of the contingent consideration related to the acquisition of the MuGard Rights to be $14.0 million as of the date of the acquisition. The fair value of

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these contingent payments was calculated based on estimated sales and were discounted using a rate of 15%. Changes in contingent consideration expense result from changes in the assumptions regarding probabilities of the estimated timing and amount of royalty payments to Access and the discount rate used to estimate the fair value of the liability. Contingent consideration expense may change significantly as we gain more information related to sales of MuGard , impacting our assumptions. The assumptions used in estimating fair value require significant judgment. The use of different assumptions and judgments could result in a materially different estimate of fair value.

N. Collaborative Agreements

Our commercial strategy includes the formation of collaborations with other pharmaceutical companies to facilitate the sale and distribution of Feraheme/Rienso , primarily outside of the U.S, as well as expanding our portfolio through the in-license or purchase of additional commercialized specialty pharmaceutical products. In addition to our collaborative agreements described in Note N to the Financial Statements in our Annual Report on Form 10-K for the year ended December 31, 2012, we were a party to the collaboration arrangements described below as of June 30, 2013.

Takeda

In March 2010, we entered into a License, Development and Commercialization Agreement, or the Takeda Agreement, with Takeda under which we granted exclusive rights to Takeda to develop and commercialize Feraheme/Rienso as a therapeutic agent in Europe, certain Asia-Pacific countries (excluding Japan, China and Taiwan), the Commonwealth of Independent States, Canada, India and Turkey. In June 2012, we entered into an amendment to the Takeda Agreement, or the Amended Takeda Agreement, which removed the Commonwealth of Independent States from the territories under which Takeda has the exclusive rights to develop and commercialize Feraheme/Rienso. In addition, the Amended Takeda Agreement modified the timing and pricing arrangements for a supply agreement to be entered into between us and Takeda in the future, the terms related to primary and secondary manufacturing for drug substance and drug product, certain patent related provisions, and the re-allocation of certain of the agreed-upon milestone payments. We analyzed the Amended Takeda Agreement and determined that the amended terms did not result in a material modification of the original Takeda Agreement (and thus did not require us to change our accounting model) because (i) there were no changes to the deliverables under the original Takeda Agreement as a result of the amendment, and (ii) the change in arrangement consideration as a result of the amendment was not quantitatively material in relation to the total arrangement consideration.

Under the Amended Takeda Agreement, except under limited circumstances, we have retained the right to manufacture Feraheme/Rienso and, accordingly, are responsible for supply of Feraheme/Rienso to Takeda at a fixed price per unit, which is capped for a certain period of time. We are also responsible for conducting, and bearing the costs related to, certain pre-defined 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. We have determined that our obligations under the Amended Takeda Agreement have not changed from those under the original Takeda Agreement and include the following four deliverables: the license, access to future know-how and improvements to the Feraheme/Rienso technology, regulatory and clinical research activities, and the manufacturing and supply of product. Pursuant to the accounting guidance in effect in March 2010, when we signed the original Takeda Agreement and which governed revenue recognition on multiple element arrangements, we evaluated the four deliverables under the original Takeda Agreement and determined that our obligation to provide manufacturing supply of product meets the criteria for separation and is therefore treated as a single unit of accounting, which we refer to as the supply unit of accounting. Further, we concluded that the license is not separable from the undelivered future know-how and technological improvements or the undelivered regulatory and clinical research activities. Accordingly, these deliverables are being

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combined and also treated as a single unit of accounting, which we refer to as the combined unit of accounting. With respect to the combined unit of accounting, our obligation to provide access to our future know-how and technological improvements is the final deliverable and is an obligation which exists throughout the term of the Amended Takeda Agreement.

In connection with the execution of the original Takeda Agreement, we received a $60.0 million upfront payment from Takeda in April 2010, which we recorded as deferred revenue, as well as approximately $1.0 million reimbursed to us during 2010 for certain expenses incurred prior to entering the agreement, which we considered an additional upfront payment. Because we cannot reasonably estimate the total level of effort required to complete the obligations under the combined deliverable, we are recognizing the entire $60.0 million upfront payment, the $1.0 million reimbursed to us in 2010, as well as any non-substantive milestone payments that are achieved into revenues on a straight-line basis over a period of ten years from March 31, 2010, the date on which we originally entered the Takeda Agreement, which represented the then-current patent life of Feraheme/Rienso and our best estimate of the period over which we will substantively perform our obligations. We continue to believe that the then-current patent life of Feraheme/Rienso is our best estimate of the period over which we will substantively perform our obligations under this agreement.

In addition, the remaining milestone payments we may be entitled to receive under the agreement could over time equal up to $186.0 million. For any milestone payments we may receive based upon the approval by certain regulatory agencies, we have determined that these will be deemed substantive milestones and, therefore, will be accounted for as revenue in the period in which they are achieved. In June 2012, we earned a $15.0 million milestone payment from Takeda based on the European Commission marketing authorization for ferumoxytol. We deemed the $15.0 million milestone payment as a substantive milestone and therefore recognized the full amount as revenue in the three and six months ended June 30, 2012 in our condensed consolidated statements of operations. We have also determined that any non-substantive milestone payments will be accounted for in accordance with our revenue attribution method for the upfront payment, as described above. During 2012, we received an aggregate of $18.0 million in milestone payments from Takeda associated with the commercial launches of Feraheme/Rienso in Canada and the EU, which we deemed to be non-substantive milestone payments. Revenues related to the combined unit of accounting are recorded in license fee and other collaboration revenues in our condensed consolidated statement of operations. During the three and six months ended June 30, 2013, we recorded $1.5 million and $3.0 million in revenues, respectively, associated with the upfront payment. In addition, during the three and six months ended June 30, 2013, we recorded $0.5 million and $0.9 million, respectively associated with the $18.0 million in non-substantive milestone payments we received in 2012. Any potential non-substantive milestone payments that may be received in the future will be recognized as revenue on a cumulative catch up basis when they become due and payable.

We have received and may also receive additional regulatory approval and performance-based milestone payments, reimbursement of certain out-of-pocket regulatory and clinical supply costs, defined payments for supply of Feraheme/Rienso, and tiered double-digit royalties on net product sales in the agreed-upon territories under the Amended Takeda Agreement.

Under the terms of the Amended Takeda Agreement, Takeda is responsible for reimbursing us for certain out-of-pocket regulatory and clinical trial supply costs associated with carrying out our regulatory and clinical research activities under the collaboration agreement. Because we are acting as the principal in carrying out these services, any reimbursement payments received from Takeda are recorded in license fee and other collaboration revenues in our condensed consolidated statement of operations to match the costs that we incur during the period in which we perform those services. During each of the three and six months ended June 30, 2013, we recorded $0.1 million associated with other reimbursement revenues received from Takeda.

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At the time of shipment, we defer recognition of all revenue for Feraheme/Rienso sold to our licensees in our condensed consolidated balance sheets. We recognize revenues from product sales to our licensees, the related cost of goods sold, and any royalty revenues due from our licensees, in our condensed consolidated statement of operations at the time our licensees report to us that sales have been made to its customers. During the three and six months ended June 30, 2013, we recognized $0.1 million and $0.2 million, respectively, in product sales and royalty revenue related to the Amended Takeda Agreement and we have included this revenue in other product sales and royalties in our condensed consolidated statement of operations. As of June 30, 2013, we had approximately $1.4 million in deferred revenue related to product shipped to Takeda but not yet sold through to Takeda’s customers, and $1.2 million in deferred cost of product sales, which are included in our condensed consolidated balance sheet.

O. Restructuring

During 2012 and 2011, we initiated corporate restructurings, including a workforce reduction plan for which we recorded $2.2 million and $3.5 million, respectively, of restructuring related costs, primarily related to employee severance and benefits. The majority of the workforce reduction plan in 2012 was associated with our manufacturing and development infrastructure, including our decision to divest our Cambridge, Massachusetts manufacturing facility. Of the $2.2 million in restructuring expense in 2012, approximately $1.5 million was related to employee severance and benefits, and approximately $0.7 million was related to the write-down of primarily raw material inventory that was no longer usable due to the closure of the facility. The workforce reductions were substantially completed by the end of 2012 and the majority of the related expenses were paid by the end of 2012.

The following table outlines the components of our restructuring expenses which were recorded in operating expenses and current liabilities for the three and six months ended June 30, 2013 and 2012 (in thousands):

	Three Months Ended June 30,
	2013			2012
Accrued restructuring, beginning of period	$	608		$	1,763
Employee severance, benefits and related costs	11			493
Payments	(290		)	(518		)
Inventory and other adjustments	—			(10		)
Accrued restructuring, end of period	$	329		$	1,728

	Six Months Ended June 30,
	2013			2012
Accrued restructuring, beginning of period	$	1,383		$	2,366
Employee severance, benefits and related costs	50			578
Payments	(1,104		)	(1,127		)
Inventory and other adjustments	—			(89		)
Accrued restructuring, end of period	$	329		$	1,728

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

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information and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2012, or our Annual Report.

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 plan to grow Feraheme in the U.S. chronic kidney disease market and through international and label expansion; the expansion of our portfolio through the in-license or purchase of additional specialty pharmaceutical products; expectations regarding our supplemental New Drug Application for Feraheme; the timing of the response from the EMA regarding Takeda Pharmaceutical Company Limited’s Type II variation; our expectations regarding the timing for enrollment in and commencement of our pediatric studies and post-approval trials; our plans for a post-approval trial to assess the safety and efficacy of repeat doses of Feraheme for the treatment of iron deficiency anemia; our expectation that 3SBio, Inc. will begin a clinical trial if approved by the Chinese State Food and Drug Administration; our expectation of costs to be incurred in connection with and revenue sources to fund our future operations; our expectation for the patient population for Feraheme in the U.S.; our expectations regarding the success of our collaboration with Takeda Pharmaceutical Company Limited, including any potential milestone payments, product sales or royalties we may receive; plans and expectations for our Cambridge, Massachusetts manufacturing facility and our new facility in Waltham, Massachusetts; our expectations regarding the manufacture of all Feraheme/Rienso drug substance and drug product at our third-party manufacturers; our expectations regarding customer returns and related reserves and accruals; our expectations regarding the validity of our European ferumoxytol patent and timing of the appeals process; our expectations regarding the Branded Drug Fee under the Health Care Reform Act and the Medicare reimbursement rate for Feraheme; our expectations regarding our license fee and other collaboration revenues; the effect of price increases; expected customer mix and utilization rates; expectations regarding MuGard and our license arrangement with Access Pharmaceuticals, Inc.; the valuation of certain intangible assets and other assets and liabilities, including our methodology and assumptions regarding fair value measurements; our gross-to-net sales adjustments; our Citizen’s Petition; our expectation for our costs of product sales as a percentage of net product sales and royalties, our research and development expenses, external expenses and the timing of our planned research and development projects, and selling, general and administrative expenses; our belief regarding the potential impact of the adoption of newly issued and future accounting guidance on our financial statements; our expectations for our cash, cash equivalents and investments balances 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 Part II, Item 1A below under “Risk Factors” in this Quarterly Report on Form 10-Q and in Part I, Item 1A in our Annual Report. 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 U.S. 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.

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Overview

On June 6, 2013, we entered into a License Agreement with Access Pharmaceuticals, Inc., or Access, under which we acquired the U.S. commercial rights to MuGard , or the Access License Agreement. Access is a company focused on developing a range of pharmaceutical products primarily based upon its polymer chemistry technologies and other drug delivery technologies. MuGard was launched by Access in 2010 after receiving 510(k) clearance from the FDA. It is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. Under the Access License Agreement, Access granted us an exclusive, royalty-bearing license, with the right to grant sublicenses, to certain intellectual property rights, including know-how, patents and trademarks, to use, import, offer for sale, sell, manufacture and commercialize MuGard in the U.S. and its territories, or the U.S. Territory, for the management of all diseases or conditions of the oropharyngeal cavity, including mucositis, or the MuGard Rights. In addition, Access has assigned us all of its right, title and interest in MuGard -related internet and social media outlets and other sales, marketing and promotional materials currently owned or controlled by Access, because, pursuant to the Access License Agreement, Access will no longer commercialize, market, promote, sell or make public communications relating to MuGard in the U.S. Territory, except as may be agreed to by us. We sell MuGard to wholesalers and specialty and retail pharmacies. See Note G to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for additional information regarding the Access License Agreement and the MuGard Rights .

International Expansion of Ferumoxytol

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well as in Iceland and Norway. Under our amended agreement with Takeda Pharmaceutical Company Limited, or Takeda, Takeda has an exclusive license to market and sell ferumoxytol in Canada, the EU and Switzerland, as well as certain other geographic territories. In Canada, Takeda promotes ferumoxytol under the trade name Feraheme and in the EU and Switzerland, Takeda promotes ferumoxytol under the trade name Rienso ® 30mg/ml solution for Injection.

Label Expansion of Ferumoxytol

We believe that a significant opportunity exists in the U.S. for Feraheme beyond the treatment of IDA in adult patients with CKD. In the U.S., approximately 800,000 grams of IV iron were administered for the treatment of non-dialysis patients with IDA in 2012. We believe that approximately half, or 400,000 grams, of the IV iron administered in the U.S. was for the treatment of non-dialysis patients with CKD and the other half was for non-CKD patients with IDA due to other causes, including patients with gastrointestinal diseases or disorders, abnormal uterine bleeding, inflammatory diseases, and chemotherapy-induced anemia.

In 2012, we completed a phase III clinical program for Feraheme in patients with IDA who had failed to or could not use oral iron. The IDA program consisted of two controlled, multi-center phase III clinical trials, or IDA-301 and IDA-302, including more than 1,400 patients, which evaluated the safety and efficacy of ferumoxytol for the treatment of IDA in this broader patient population. Both studies met the primary efficacy endpoints related to improvements in hemoglobin. In these studies no new safety signals were observed with Feraheme treatment and the types of reported adverse events were consistent with those seen in previous studies and those contained in the approved U.S. package insert for Feraheme . In addition, patients from IDA-301 were eligible to enroll in an open-label extension study, or IDA-303, and receive treatment with Feraheme, as defined in the protocol.

In December 2012, we submitted a supplemental new drug application, or sNDA, to the FDA, seeking approval for Feraheme for the treatment of IDA in adult patients who have failed to or could not use oral iron. The sNDA submission was primarily based on the data from IDA-301 and IDA-302. In addition, the sNDA included data from an interim analysis of IDA-303 and a previously completed post-approval clinical study evaluating Feraheme treatment compared to treatment with another IV iron. We believe that approval for Feraheme for this expanded indication would effectively double the market opportunity for Feraheme , by allowing us to access the half of the non-dialysis IV iron market that is beyond our current approved indication to treat IDA in adult patients with CKD. In March 2013, the FDA accepted our sNDA for review. Under the guidelines of the Prescription Drug User Fee Act, or PDUFA, the FDA has set October 21, 2013 as a target date for completion of their review.

In June 2013, Takeda filed a Type II Variation, which is the EU equivalent of a U.S. sNDA, with the European Medicines Agency, or EMA, seeking marketing approval for Rienso for the treatment of IDA in adult patients. Takeda expects a response from the EMA in the first half of 2014.

Takeda Collaboration

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had approximately $1.4 million in deferred revenue related to product shipped to Takeda, but not yet sold through to Takeda’s customers and $1.2 million in deferred cost of product sales.

Clinical Development of Feraheme

We have amended and combined into one study the two previously initiated randomized, active-controlled pediatric studies of Feraheme for the treatment of IDA in pediatric CKD patients to meet our FDA post-approval Pediatric Research Equity Act requirement to support pediatric labeling of Feraheme in the U.S . The amended study covers both dialysis-dependent and non-dialysis dependent CKD pediatric patients. The combined study will assess the safety and efficacy of Feraheme treatment as compared to oral iron in approximately 288 pediatric patients.

Our pediatric investigation plan, which was a requirement for submission of the Marketing Authorization Application, or MAA, for ferumoxytol, was approved by the EMA in December 2009 and amended in 2012, and includes the pediatric studies as amended and described above, and two additional pediatric studies requested by the EMA. These studies include a rollover extension study in pediatric CKD patients and a study in pediatric patients with IDA regardless of the underlying cause. The rollover study is open for enrollment. The pediatric IDA study will commence once the appropriate dose of Feraheme is determined from the study data resulting from the amended pediatric studies of Feraheme , described above.

As part of our obligations under the Amended Takeda Agreement and as part of our post-approval commitments to the EMA, we initiated a multi-center clinical trial to determine the safety and efficacy of repeat doses of ferumoxytol for the treatment of IDA in patients with hemodialysis dependent CKD. As part of the post-approval commitment we made to the EMA as a condition of the approval of the MAA for ferumoxytol in the EU, this study includes a treatment arm with iron sucrose using a magnetic resonance imaging, or MRI, sub-analysis to evaluate the potential for iron to accumulate in the body following treatment with IV iron, specifically in the heart and liver, and, where possible, other major organs following repeated IV iron administration over a two year period. Clinical sites were activated for enrollment in the second quarter of 2013. The costs related to the MRI portion of this study are subject to our established cost-sharing arrangement with Takeda.

From time to time, we or our licensees may sponsor pilot clinical studies or collaborate with investigators on their research ideas to evaluate the safety and efficacy of Feraheme in new indications or alternative dosing regimens.

In addition, certain clinical trials may be necessary to secure desired pricing in various European markets. If so, the cost of any future trials may be allocated between us and Takeda according to the cost-sharing arrangement under the Amended Takeda Agreement.

Our licensee 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 clinical trial necessary to file for marketing approval of Feraheme in China. If approved by the SFDA, 3SBio plans to commence a multi-center randomized efficacy and safety study of Feraheme in China involving approximately 200 CKD patients with IDA.

Results of Operations — Three Months Ended June 30, 2013 and 2012

Revenues

Total revenues for the three months ended June 30, 2013 and 2012 consisted of the following (in thousands):

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	Three Months Ended June 30,
	2013		2012		$ Change			% Change
U.S. Feraheme product sales, net	$	17,456	$	14,094	$	3,362		24	%
License fee and other collaboration revenues	2,055		16,592		(14,537		)	-88	%
Other product sales and royalties	138		326		(188		)	-58	%
Total	$	19,649	$	31,012	$	(11,363	)	-37	%

Total revenues during the three months ended June 30, 2013 decreased by $11.4 million as compared to the same period in 2012, primarily as the result of our receipt of a $15.0 million milestone payment from Takeda earned by us in June 2012, partially offset by a $3.4 million increase in U.S. net Feraheme product sales and a $0.5 million increase in license fee and other collaboration revenues associated with our collaboration agreement with Takeda during the three months ended June 30, 2013.

U.S. Feraheme Sales, Net

U.S. Feraheme sales and our product sales allowances and accruals for the three months ended June 30, 2013 and 2012 consisted of the following (in thousands):

	Three Months Ended June 30,
	2013		Percent of gross U.S. Feraheme product sales		2012			Percent of gross U.S. Feraheme product sales		$ Change		% Change
Gross U.S. Feraheme product sales	$	29,654			$	22,320				$	7,334	33	%
Less provision for product sales allowances and accruals
Discounts and chargebacks	9,227		31	%	6,846			31	%
Government and other rebates	2,732		9	%	1,672			7	%
Returns	239		1	%	(292		)	-1	%
Total	12,198		41	%	8,226			37	%

Net U.S. Feraheme product sales	$	17,456			$	14,094				$	3,362	24	%

Our gross U.S. Feraheme product sales increased by $7.3 million during the three months ended June 30, 2013 as compared to the same period in 2012. Of the $7.3 million increase, $5.4 million was due to increased units sold and $1.9 million was due to price increases. This increase was partially offset by $3.4 million of additional allowances and accruals in 2013 excluding a $0.6 million credit related to changes in estimated product return reserves that we recorded in the three months ended June 30, 2012. As a result of these factors, total U.S. net Feraheme product sales increased by $3.4 million during the three months ended June 30, 2013 as compared to the same period in 2012.

Total discounts and chargebacks in the three months ended June 30, 2013 were $9.2 million, or 31% of total gross U.S. Feraheme product sales, remaining stable as compared to $6.8 million, or 31%, in the same period of 2012.

Total government and other rebates were $2.7 million, or 9% of total gross U.S. Feraheme product sales, in the three months ended June 30, 2013 as compared to $1.7 million, or 7%, in the three months ended June

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30, 2012. The increase in total government and other rebates as a percentage of gross U.S. Feraheme product sales was related primarily to increased volumes of sales that are covered by volume or market share rebates offered in the three months ended June 30, 2013 as compared to the same period in 2012.

As noted above, during the three months ended June 30, 2012, we reduced our reserve for product returns by approximately $0.6 million due to the lapse of the product return period on certain manufactured Feraheme lots that carried a two year expiration. As a result, the product returns provision applied to gross U.S. Feraheme product sales for the three months ended June 30, 2012 was a credit of $0.3 million resulting in an increase to product sales during that period. We did not make any adjustment to our reserve for product returns during the three months ended June 30, 2013. Actual returns to date have been limited. In future periods, we may be required to adjust our estimates based on additional experience or other changes in expectations, which would result in a corresponding change to our net product sales in the period in which the change is made and could be significant. If actual future results vary from any of our estimates, we may need to adjust our previous estimates, which would also affect our earnings in the period of the adjustment.

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 and Note B to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

Overall, we expect that our reserves as a percentage of gross sales of Feraheme will increase slightly during the remainder of 2013 as compared to the six months ended June 30, 2013 due primarily to our efforts to continue to increase adoption and utilization of Feraheme , our efforts to address continuing reimbursement pressures, our entry into new volume or market share based contracts which offer discounts and rebates, and the expected customer mix and utilization rates. We recently implemented gross price increases for Feraheme, some of which were discounted back to customers under volume or market share based contracts. We anticipate that the effect of these price increases should offset the impact of the widening gross to net adjustment and that the average net revenue per gram of Feraheme should continue to increase in future periods. However, this trend could be negatively affected based on recent sequestration required by the Budget Control Act of 2011, as amended by the American Taxpayer Relief Act of 2012, as discussed below.

There are a number of factors that make it difficult to predict the magnitude of future Feraheme sales, including but not limited to, the following:

· The magnitude and timing of adoption of Feraheme by physicians, hospitals and other healthcare payors and providers;

· Any expansion or contraction of the overall size of the IV iron market, which could result from a number of factors including but not limited to, changes in treatment guidelines or practices related to IDA;

· The introduction of new competitive products in the iron replacement therapeutic market, such as the recent approval of Injectafer ® or potential generic versions of new or currently available drug therapies;

· The effect of federal and other legislation such as The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or the Health Care Reform Act, and the Budget Control Act of 2011, including the effect of the recent federal budget sequester on Medicare reimbursement rates which may cause a shift in where patients are treated to sites of care that have a lower mandated price for Feraheme , such as 340B institutions;

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· The inventory levels maintained by Feraheme wholesalers, distributors and other customers;

· The frequency of re-orders by existing customers;

· The fees charged, and reserves required, related to fees for services provided to wholesalers, distributors, group purchasing organizations and others involved in the purchase or distribution of Feraheme ;

· The impact of any actual or perceived safety or efficacy issues with Feraheme and any related product recalls ;

· The impact of any difficulties, disruptions or delays in the manufacturing process for Feraheme/Rienso ; and

· The impact of and any actions taken by us or our competitors to address pricing and reimbursement considerations related to Feraheme or products that compete with Feraheme .

As a result of these and other factors, future Feraheme sales could vary significantly from quarter to quarter and, accordingly, our Feraheme net product revenues in current or previous quarters may not be indicative of future Feraheme net product revenues.

Recent Healthcare Reform Legislation

The Health Care Reform Act was enacted in the U.S. in March 2010 and includes certain cost containment measures including an increase to the minimum rebates for products covered by Medicaid programs and the extension of such rebates to drugs dispensed to Medicaid beneficiaries enrolled in Medicaid managed care organizations as well as the expansion of the 340B Drug Discount Program under the Public Health Service Act. This legislation contains provisions that can affect the operational results of companies in the pharmaceutical industry, including us, and other healthcare related industries by requiring them to pay additional rebate costs. For example, in the first quarter of 2010, the minimum statutory Medicaid rebate to states participating in the Medicaid program increased from 15.1% to 23.1%. Given the relatively small portion of our sales that are subject to Medicaid claims, this increase in the minimum Medicaid rebate did not materially reduce our product revenues during the three or six months ended June 30, 2013.

The Health Care Reform Act also requires pharmaceutical manufacturers to pay a prorated share of the overall Branded Drug Fee, based on the dollar value of its branded prescription drug sales to certain federal programs identified in the legislation. The amount of our annual share of the Branded Drug Fee for each of 2013 and 2012 was less than $0.1 million and these payments were non-deductible for income tax purposes. We have included these amounts in selling, general and administrative expense in our condensed consolidated statements of operations. The amount of this annual payment could increase in future years due to both higher eligible Feraheme sales and the increasing amount of the overall fee assessed across manufacturers, but any such increases are not expected to be material to our results of operations or financial condition.

In addition, the number of 340B institutions, which provide drugs at reduced rates, was expanded by the Health Care Reform Act to include additional hospitals. The volume of Feraheme business sold to 340B eligible entities is growing faster than the volume of Feraheme business sold to other customers to which we sell, partially as the result of the expansion of 340B eligible entities under the Health Care Reform Act. Feraheme demand within 340B institutions has grown 29% since the second quarter of 2012 as compared to 25% growth in total Feraheme demand during the same period. Because of the federal

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pricing discounts granted to these 340B institutions, the revenue realized per unit of Feraheme sold to 340B institutions is lower than from other customers.

Further, under the sequestration required by the Budget Control Act of 2011, as amended by the American Taxpayer Relief Act of 2012, Medicare payments for all items and services under Parts A and B incurred on or after April 1, 2013 have been reduced by up to 2%. Therefore, after adjustment for deductible and co-insurance, the reimbursement rate for physician-administered drugs including Feraheme , under Medicare Part B has been reduced from average selling price, or ASP, plus 6% to ASP plus 4.3%. Because the majority of our business is through hematology/oncology clinics and out-patient hospital infusion centers, this reduction in the Medicare reimbursement payment for Feraheme may adversely impact our future revenues. We have not determined the magnitude of the impact of this reduction in the Medicare reimbursement rate on our net sales; however, beginning in April 2013, we amended certain of our customer contracts to try to partially address the impact of sequestration on our customers and their patients. These changes could cause our discounts and rebates to rise in future periods and negatively impact our net sales.

License Fee and Other Collaboration Revenues

License fee and other collaboration revenues for the three months ended June 30, 2013 and 2012 consisted of the following (in thousands):

	Three Months Ended June 30,
	2013		2012		$ Change			% Change
Milestone revenues recognized from Takeda	$	—	$	15,000	$	(15,000	)	-100	%
Deferred license fee revenues recognized from Takeda	1,974		1,524		450			30	%
Reimbursement revenues primarily from Takeda	81		68		13			19	%
Total	$	2,055	$	16,592	$	(14,537	)	-88	%

Our license fee and other collaboration revenues in the three months ended June 30, 2013 decreased by $14.5 million as compared to the same period in 2012 primarily as the result of the $15.0 million milestone payment earned in June 2012 under the Amended Takeda Agreement upon the marketing authorization granted for ferumoxytol by the European Commission. The $15.0 million decrease was partially offset by $0.5 million of revenue recognized during the three months ended June 30, 2013, which represents the amortized portion of an aggregate of $18.0 million in milestone payments we received from Takeda during the second half of fiscal 2012 related to the commercial launches of Feraheme/Rienso in Canada and the EU. At the time of receipt, we determined that the $18.0 million milestone payments were considered non-substantive milestones and are amortizing them into revenue using the proportional performance method extended over the original life of the Takeda Agreement. We did not receive any non-substantive milestone payments prior to or during the three months ended June 30, 2012. As of June 30, 2013, we had approximately $12.2 million remaining in deferred revenues related to the $18.0 million milestone payments received from Takeda in 2012.

In addition, during each of the three months ended June 30, 2013 and 2012, we recorded $1.5 million of revenues associated with the amortization of $61.0 million of deferred revenues recorded in connection with the original Takeda Agreement. As of June 30, 2013, we had approximately $41.1 million remaining in deferred revenues related to the $61.0 million upfront payments received from Takeda.

Under the terms of the Amended Takeda Agreement, Takeda is responsible for reimbursing us for certain out-of-pocket regulatory and clinical trial supply costs we incur in the conduct of certain regulatory and clinical research activities we manage under the agreement. Because we are acting as the principal in carrying out these activities, any reimbursement payments received from Takeda are recorded in license fee and other collaboration revenues in our condensed consolidated statement of operations and

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offset the costs that we incur during the period in which we perform those activities. During each of the three months ended June 30, 2013 and 2012, we recorded $0.1 million of revenues associated with the reimbursement of out-of pocket regulatory and clinical supply costs in connection with the Amended Takeda Agreement.

We anticipate that our license fee and other collaboration revenues will remain relatively stable for the remainder of 2013 as compared to the six months ended June 30, 2013.

Other Product Sales and Royalties

Other product sales and royalties include product sales of Feraheme/Rienso and GastroMARK ® to our licensees, product sales of MuGard and royalties received from our licensees’ sales of Feraheme/Rienso and GastroMARK . The $0.2 million decrease in our other product sales and royalties in the three months ended June 30, 2013 as compared to the three months ended June 30, 2012 was due to decreased GastroMARK sales as a result of our 2012 termination of our agreements with our GastroMARK licensees, which resulted in no GastroMARK sales during the three months ended June 30, 2013. We have since ceased commercially manufacturing and selling GastroMARK .

We record all product sales and royalties for Feraheme/Rienso sold to Takeda in deferred revenues in our condensed consolidated balance sheet. We recognize these deferred revenues, and the associated cost of product sales, in our condensed consolidated statement of operations at the time Takeda reports to us that sales have been made to its customers. As of June 30, 2013, we had approximately $1.4 million in deferred revenue related to product shipped to Takeda, but not yet sold through to Takeda’s customers and $1.2 million in deferred cost of product sales, which are included in our condensed consolidated balance sheet.

We expect other product sales and royalties to increase for the remainder of the year as compared to the first half of the year due to increased MuGard sales as we continue to commercialize MuGard .

Costs and Expenses

Cost of Product Sales

Cost of product sales are primarily comprised of manufacturing costs, costs of managing our contract manufacturers, and costs for quality assurance and quality control associated with our sales of Feraheme in the U.S., sales of Feraheme/Rienso to Takeda, and MuGard sales. Cost of product sales, for the three months ended June 30, 2013 and 2012 consisted of the following (in thousands):

	Three Months Ended June 30,
	2013			2012			$ Change			% Change
Cost of Product Sales	$	3,145		$	3,224		$	(79	)	-2	%
Percentage of Net Product Sales and Royalties	18		%	22		%

The changes in our cost of product sales from the three months ended June 30, 2012 to the three months ended June 30, 2013 included the following factors:

· $0.8 million decrease in cost of product sales due to the 2012 closure of our Cambridge, Massachusetts manufacturing facility and other related production costs;

· $0.5 million increase in cost of product sales due to a write-off of inventory that was affected by a voluntary recall of a specific batch of Rienso from the Swiss market in May 2013;

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· $0.3 million increase in cost of product sales due to the sale of pre-approval validation lots in the three months ended June 30, 2012, which in accordance with our capitalization policy, excluded costs that had been expensed prior to FDA approval of the manufacturing process;

· $0.1 million increase in cost of product sales due to the higher volume of Feraheme vials sold in the three months ended June 30, 2013 as compared to the same period in 2012, partially offset by a lower average cost per vial sold; and

· $0.2 million decrease for costs related to sales of Feraheme/Rienso to Takeda and GastroMARK sales.

We expect our cost of product sales as a percentage of net product sales and royalties to decrease for the remainder of 2013 as compared to the first half of 2013 due primarily to the non-recurring nature of the $0.5 million inventory write-off related to the Swiss recall.

Research and Development Expenses

Research and development expenses include external expenses, such as costs of clinical trials, contract research and development expenses, investigator-sponsored research, certain manufacturing research and development costs, manufacturing process improvement costs, regulatory filing fees, 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. 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 initial regulatory approval of our products or development of new manufacturing processes, costs associated with manufacturing process development and the manufacture of drug product are recorded as research and development expenses. Subsequent to initial regulatory approval, costs associated with the manufacture of our products for commercial sale are capitalized in inventory and recorded as cost of product sales when sold.

Research and development expenses for the three months ended June 30, 2013 and 2012 consisted of the following (in thousands):

	Three Months Ended June 30,
	2013			2012		$ Change			% Change
External Research and Development Expenses
Feraheme to treat IDA in CKD patients	$	745		$	1,265	$	(520	)	-41	%
Feraheme to treat IDA regardless of the underlying cause	(398		)	2,241		(2,639		)	<(100	)%
Feraheme as a therapeutic agent, general	244			84		160			>100	%
Feraheme manufacturing process development and materials	667			335		332			99	%
Other external costs	197			22		175			>100	%
Total	$	1,455		$	3,947	$	(2,492	)	-63	%

Internal Research and Development Expenses
Compensation, payroll taxes, benefits and other expenses	2,229			3,199		(970		)	-30	%
Equity-based compensation expense	365			525		(160		)	-30	%
Total	$	2,594		$	3,724	$	(1,130	)	-30	%

Total Research and Development Expenses	$	4,049		$	7,671	$	(3,622	)	-47	%

Total research and development expenses incurred in the three months ended June 30, 2013 decreased by $3.6 million, or 47%, as compared to the three months ended June 30, 2012. The $3.6 million decrease was primarily due to reduced external research and development costs of $2.5 million in the three months

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ended June 30, 2013. In addition, internal research and development costs decreased by $1.1 million in the three months ended June 30, 2013 as compared to the same period in 2012.

The $2.5 million decrease in our external research and development expenses for the three months ended June 30, 2013 as compared to the three months ended June 30, 2012, was due primarily to a $2.6 million decrease in costs incurred in connection with our Phase III clinical development program for Feraheme to treat IDA regardless of the underlying cause, which was completed in 2012. In addition, during the three months ended June 30, 2013, we received a credit from our third-party vendor of $0.5 million related to the close-out of our Feraheme IDA program. The decrease in our external research and development costs was also due to a $0.5 million decrease in costs associated with our CKD-related clinical trials. These decreases were partially offset by a $0.3 million increase in manufacturing process development and material costs and a $0.3 million increase in general Feraheme -related and other external costs.

The $1.1 million, or 30%, decrease in internal research and development expenses in the three months ended June 30, 2013 as compared to the three months ended June 30, 2012 was primarily attributable to the decrease in compensation and related benefits following our 2012 corporate restructurings, which resulted in lower headcount in our research and development departments. In addition, equity-based compensation expense decreased by $0.2 million, or 30%, primarily as a result of the reduction of headcount, partially offset by additional equity awards to new and existing employees.

Research and Development Activities

We expect research and development expenses to fluctuate for the remainder of 2013 as compared to the three months ended June 30, 2013 and to decrease overall during 2013 as compared to 2012. The quarterly fluctuations will primarily be due to the costs associated with our pediatric studies as well as our post-approval commitment related to the 2012 approval of the Rienso MAA by the EMA, manufacturing process development costs in support of our Feraheme/Rienso development programs, as well as other miscellaneous research- and development-related activities. If enrollment in these clinical studies progresses faster than planned or the development of certain manufacturing process improvements proceeds as planned, we could experience an increase in our research and development expenses for the remainder of the year as compared to the six months ended June 30, 2013. If enrollment in the clinical studies is slower or the manufacturing process improvements proceed slower, then our research and development expenses for the remainder of 2013 will be more consistent with those incurred in the six months ended June 30, 2013. Overall, we expect research and development expenses during 2013 to decrease, as compared to 2012, primarily due to the 2012 completion of our Phase III clinical development program for Feraheme to treat IDA regardless of the underlying cause and also due to lower compensation and related benefits costs in 2013 following our 2012 corporate restructurings, which resulted in lower headcount in our research and development departments.

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 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. The following two major research and development projects are currently ongoing:

· Feraheme to treat IDA regardless of the underlying cause . This project was completed in the second quarter of 2013 and consisted of the following studies: (1) a completed Phase III clinical study evaluating Feraheme treatment as compared to treatment with placebo; (2) a completed Phase III clinical study evaluating Feraheme treatment as compared to treatment with another IV iron; and (3) a completed extension study.

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· Feraheme to treat IDA in CKD patients . This project currently includes: (1) a completed clinical study evaluating Feraheme treatment as compared to treatment to another IV iron to support the 2010 MAA submission; (2) a pediatric study that is being conducted as part of our post-approval Pediatric Research Equity Act requirement to support pediatric CKD labeling of Feraheme ; (3) two additional pediatric studies to be completed in accordance with our approved pediatric investigation plan to support the MAA submission; (4) an ongoing multi-center clinical trial to determine the safety and efficacy of repeat doses of Feraheme for the treatment of IDA in patients with hemodialysis dependent CKD, including a treatment arm with iron sucrose using an MRI sub-analysis to evaluate the potential for iron to accumulate in the body following repeated IV iron administration.

Through June 30, 2013, we have incurred aggregate external research and development expenses of approximately $57.8 million related to our current program for the development of Feraheme to treat IDA regardless of the underlying cause. We track our external costs by major project, in most cases through the final regulatory submission. In July 2013, Takeda submitted a Type II variation with the EMA seeking marketing approval for Rienso for the treatment of IDA in adult patients and therefore because we do not expect to incur additional costs related to this project we do not intend to continue to track external costs for this project.

Through June 30, 2013, we have incurred aggregate external research and development expenses of approximately $25.4 million related to our current program for the development of Feraheme to treat IDA in CKD patients. We currently estimate that the total remaining external costs associated with this development project will be in the range of approximately $22.0 to $32.0 million over the next several years.

Selling, General and Administrative Expenses

Selling, general and administrative expenses include costs related to our commercial personnel, including our specialty sales force, medical education professionals, pharmacovigilance and safety monitoring and other commercial support personnel, costs related to our administrative personnel, including our legal, finance, business development, human resources, information technology, investor relations and executive personnel, external and facilities costs required to support the marketing and sale of Feraheme and MuGard and other costs associated with our corporate activities.

Selling, general and administrative expenses for the three months ended June 30, 2013 and 2012 consisted of the following (in thousands):

	Three Months Ended June 30,
	2013		2012		$ Change			% Change
Compensation, payroll taxes and benefits	$	5,709	$	6,151	$	(442	)	-7	%
Sales and marketing consulting, professional fees, and other expenses	3,219		3,494		(275		)	-8	%
General and administrative consulting, professional fees and other expenses	4,744		4,472		272			6	%
Equity-based compensation expense	1,539		984		555			56	%
Total	$	15,211	$	15,101	$	110		1	%

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Total selling, general and administrative expenses incurred in the three months ended June 30, 2013 remained relatively stable as compared to the three months ended June 30, 2012 for the following reasons:

· $0.4 million decrease in compensation, payroll taxes and benefits during the three months ended June 30, 2013 as compared to the same period in 2012 due to reduced headcount in our sales and marketing functions primarily related to the realignment of our sales territories during 2012;

· $0.3 million decrease in sales and marketing consulting, professional fees, and other expenses during the three months ended June 30, 2013 as compared to the same period in 2012 primarily due to costs associated with a reduced headcount in our sales and marketing functions, partially offset by increased costs related to advertising and marketing materials and certain other general marketing costs incurred in connection with the preparation of the potential commercial launch of Feraheme in the broader IDA market;

· $0.3 million increase in general and administrative consulting, professional fees and other expenses during the three months ended June 30, 2013 as compared to the same period in 2012 primarily due to $0.8 million of transaction and other costs related to the acquisition of the MuGard Rights, $0.3 million of increased consulting and other legal activities, including costs relating to the Physician Payment Sunshine Act and related regulations, $0.4 million of increased accelerated depreciation expense related to certain leasehold improvements and furniture and fixtures associated with a portion of our principal executive offices to reflect our current estimate of useful lives of these assets, and $0.3 million of expense related to the closure of our Cambridge, Massachusetts manufacturing facility. Additional accelerated depreciation expense related to leasehold improvements and furniture and fixtures could be possible in future periods. These increased costs were partially offset by $1.6 million in termination fees which we paid during the three months ended June 30, 2012 to our GastroMARK licensees in connection with the termination of our license agreements with them.

· $0.6 million increase in equity-based compensation expense for the three months ended June 30, 2013 as compared to the three months ended June 30, 2012 due primarily to the expense associated with equity awards to new and existing employees.

We expect total selling, general and administrative expenses will increase slightly for the remainder of the year as compared to the first half of 2013 due to costs associated with the preparing for a potential launch of Feraheme in the broader IDA market, updating our product label and marketing materials and increasing our marketing costs in support of a larger physician and patient opportunity if regulatory approval is obtained, and marketing materials and costs associated with the commercialization of MuGard .

Other Income (Expense)

Other income (expense) for the three months ended June 30, 2013 and 2012 consisted of the following (in thousands):

	Three Months Ended June 30,
	2013		2012			$ Change			% Change
Interest and dividend income, net	$	256	$	338		$	(82	)	-24	%
Gains on sale of assets	566		—			566			N/A
Gains (losses) on investments, net	26		(1,471		)	1,497			<(100	)%
Total	$	848	$	(1,133	)	$	1,981		<(100	)%

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Other income (expense) for the three months ended June 30, 2013 increased by $2.0 million as compared to the three months ended June 30, 2012. This increase was primarily attributable to non-recurring nature of the June 2012 $1.5 million loss realized on the sale of our then-remaining auction rate securities. Additionally, during the three months ended June 30, 2013, we recognized $0.5 million of gains in connection with the sale of Combidex ® , a molecular imaging agent for which we were not actively pursuing development, and $0.1 million gains on the sale of fixed assets related to our Cambridge, Massachusetts manufacturing facility. These increases in other income (expense) were partially offset by a decrease in interest and dividend income primarily as the result of lower average cash balances during the three months ended June 30, 2013 as compared to the same period in 2012.

We expect interest and dividend income for the remainder of 2013 to remain relatively consistent as compared to the first half of 2013.

Net (Loss) Income

For the reasons stated above, we incurred a net loss of $1.9 million, or $0.09 per basic and diluted share, for the three months ended June 30, 2013 as compared to net income of $3.3 million, or $0.16 per basic share and $0.15 per diluted share, for the three months ended June 30, 2012.

Results of Operations - Six Months Ended June 30, 2013 and 2012

Revenues

Total revenues for the six months ended June 30, 2013 and 2012 consisted of the following (in thousands):

	Six Months Ended June 30,
	2013		2012		$ Change			% Change
U.S. Feraheme product sales, net	$	33,034	$	27,720	$	5,314		19	%
License fee and other collaboration revenues	4,058		18,345		(14,287		)	-78	%
Other product sales and royalties	437		427		10			2	%
Total	$	37,529	$	46,492	$	(8,963	)	-19	%

Total revenues during the six months ended June 30, 2013 decreased by $9.0 million as compared to the same period in 2012, primarily as the result of our receipt of a $15.0 million milestone payment earned by us in June 2012, partially offset by a $5.3 million increase in U.S. net Feraheme product sales and a $0.7 million increase in license fee and other collaboration revenues associated with our collaboration agreement with Takeda during the six months ended June 30, 2013.

U.S. Feraheme Product Sales, Net

U.S. Feraheme product sales and our product sales allowances and accruals for the six months ended June 30, 2013 and 2012 consisted of the following (in thousands):

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	Six Months Ended June 30,
	2013		Percent of gross U.S. Feraheme product sales		2012			Percent of gross U.S. Feraheme product sales		$ Change		% Change
Gross U.S. Feraheme product sales	$	55,305			$	43,032				$	12,273	29	%
Less provision for product sales allowances and accruals
Discounts and chargebacks	16,720		30	%	12,738			30	%
Government and other rebates	5,119		9	%	3,132			7	%
Returns	432		1	%	(558		)	-1	%
Total	22,271		40	%	15,312			36	%

Net U.S. Feraheme product sales	$	33,034			$	27,720				$	5,314	19	%

Our gross U.S. Feraheme product sales increased by $12.3 million during the six months ended June 30, 2013 as compared to the same period in 2012. Of the $12.3 million increase, $8.4 million was due to increased units sold and $3.9 million was due to price increases. This increase was partially offset by $5.9 million of additional allowances and accruals in 2013, excluding a $1.1 million credit related to changes in estimated product return reserves that we recorded in the six months ended June 30, 2012. As a result of these factors, total net U.S. Feraheme product sales increased by $5.3 million during the six months ended June 30, 2013 as compared to the same period in 2012.

Total discounts and chargebacks in the six months ended June 30, 2013 were $16.7 million, or 30% of total gross U.S. Feraheme product sales, remaining stable as compared to $12.7 million, or 30%, in the same period of 2012.

Total government and other rebates were $5.1 million, or 9% of total gross U.S. Feraheme product sales, in the six months ended June 30, 2013 as compared to $3.1 million, or 7%, in the six months ended June 30, 2012. The increase in total government and other rebates as a percentage of gross U.S. Feraheme product sales was related primarily to increased volumes of sales that are covered by volume or market share rebates offered in the six months ended June 30, 2013 as compared to same period in 2012.

As noted above, during the six months ended June 30, 2012, we reduced our reserve for product returns by approximately $1.1 million due to the lapse of the product return period on certain manufactured Feraheme lots that carried a two year expiration. As a result, the product returns provision applied to gross U.S . Feraheme product sales for the six months ended June 30, 2012 was a credit of $0.6 million resulting in an increase to product sales during that period. We did not make any adjustment to our reserve for product returns during the six months ended June 30, 2013. Actual returns to date have been limited. In future periods, we may be required to adjust our estimates based on additional experience or other changes in expectations, which would result in a corresponding change to our net product sales in the period in which the change is made and could be significant. If actual future results vary from any of our estimates, we may need to adjust our previous estimates, which would also affect our earnings in the period of the adjustment.

An analysis of the amount of, and change in, reserves for the six months ended June 30, 2013 and 2012 is as follows (in thousands):

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	Discounts			Rebates and Fees			Returns		Total
Balance at January 1, 2013	$	1,771		$	2,430		$	1,018	$	5,219
Current provisions relating to sales in current year	16,720			5,119			432		22,271
Payments/returns relating to sales in current year	(15,521		)	(2,268		)	—		(17,789		)
Payments/returns relating to sales in prior years	(310		)	(1,511		)	—		(1,821		)
Balance at June 30, 2013	$	2,660		$	3,770		$	1,450	$	7,880

	Discounts			Rebates and Fees			Returns			Total
Balance at January 1, 2012	$	1,822		$	3,101		$	2,842		$	7,765
Current provisions relating to sales in current year	12,738			3,226			531			16,495
Adjustments relating to sales in prior years	—			(94		)	(1,089		)	(1,183		)
Payments/returns relating to sales in current year	(10,644		)	(1,574		)	—			(12,218		)
Payments/returns relating to sales in prior years	(1,859		)	(1,584		)	(290		)	(3,733		)
Balance at June 30, 2012	$	2,057		$	3,075		$	1,994		$	7,126

During the six months ended June 30, 2012, we decreased our product sales allowances and accruals by approximately $1.2 million for changes in estimates relating to sales in prior years. The $1.2 million adjustments in the six months ended June 30, 2012 were primarily caused by the reduction of our reserve by $1.1 million for previously reserved returns, as discussed above. We did not record any changes in estimates relating to sales in prior years during the six months ended June 30, 2013.

License Fee and Other Collaboration Revenues

License fee and other collaboration revenues for the six months ended June 30, 2013 and 2012 consisted of the following (in thousands):

	Six Months Ended June 30,
	2013		2012		$ Change			% Change
Milestone revenues recognized from Takeda	$	—	$	15,000	$	(15,000	)	-100	%
Deferred license fee revenues recognized from Takeda	3,948		3,048		900			30	%
Reimbursement revenues primarily from Takeda	110		297		(187		)	-63	%
Total	$	4,058	$	18,345	$	(14,287	)	-78	%

Our license fee and other collaboration revenues in the six months ended June 30, 2013 decreased by $14.3 million as compared to the same period in 2012 primarily as the result of the $15.0 million milestone payment earned in June 2012 under the Amended Takeda Agreement upon the marketing authorization granted for ferumoxytol by the European Commission. This $15.0 million decrease was partially offset by $0.9 million of revenue recognized during the six months ended June 30, 2013 as the result of the amortization of the $18.0 million milestone payments we received from Takeda during 2012, as discussed above. We did not receive any non-substantive milestone payments prior to or during the six months ended June 30, 2012. In addition, during each of the six months ended June 30, 2013 and 2012, we recorded $3.0 million of revenues associated with the amortization of $61.0 million of deferred revenues recorded in connection with the original Takeda Agreement, as discussed above.

During the six months ended June 30, 2013 and 2012, we also recorded $0.1 million and $0.3 million, respectively, of revenues associated with the reimbursement of out-of pocket regulatory and clinical supply costs in connection with the Amended Takeda Agreement.

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Other Product Sales and Royalties

Our other product sales and royalties in the six months ended June 30, 2013 remained relatively constant as compared to the six months ended June 30, 2012 and consisted of GastroMARK sales to our licensees and sales and royalty revenue related to the Amended Takeda Agreement.

Costs and Expenses

Cost of Product Sales

Cost of product sales, for the six months ended June 30, 2013 and 2012 consisted of the following (in thousands):

	Six Months Ended June 30,
	2013			2012			$ Change		% Change
Cost of Product Sales	$	6,087		$	5,870		$	217	4	%
Percentage of Net Product Sales and Royalties	18		%	21		%

The changes in our cost of product sales from the six months ended June 30, 2012 to the six months ended June 30, 2013 included the following factors:

· $1.7 million decrease in cost of product sales due to the 2012 closure of our Cambridge, Massachusetts manufacturing facility and other related production costs;

· $0.5 million increase in cost of product sales due to a write-off of inventory that was affected by a voluntary recall of a specific batch of Rienso from the Swiss market in May 2013;

· $1.0 million increase in cost of product sales due to the sale of pre-approval validation lots in the six months ended June 30, 2012, which in accordance with our capitalization policy, excluded costs that had been expensed prior to FDA approval of the manufacturing process;

· $0.4 million increase in cost of product sales due to the higher volume of Feraheme vials sold in the six months ended June 30, 2013 as compared to the same period in 2012, partially offset by a lower average cost per vial sold; and

· $0.6 million increase due to higher average production cost of certain vials sold in the six months ended June 30, 2013 as compared to the same period in 2012.

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Research and Development Expenses

Research and development expenses for the six months ended June 30, 2013 and 2012 consisted of the following (in thousands):

	Six Months Ended June 30,
	2013		2012		$ Change			% Change
External Research and Development Expenses
Feraheme to treat IDA in CKD patients	$	1,565	$	1,995	$	(430	)	-22	%
Feraheme to treat IDA regardless of the underlying cause	98		9,022		(8,924		)	-99	%
Feraheme as a therapeutic agent, general	348		172		176			>100	%
Feraheme manufacturing process development and materials	940		1,218		(278		)	-23	%
Other external costs	301		78		223			>100	%
Total	$	3,252	$	12,485	$	(9,233	)	-74	%

Internal Research and Development Expenses
Compensation, payroll taxes, benefits and other expenses	4,904		6,701		(1,797		)	-27	%
Equity-based compensation expense	1,297		947		350			37	%
Total	$	6,201	$	7,648	$	(1,447	)	-19	%

Total Research and Development Expenses	$	9,453	$	20,133	$	(10,680	)	-53	%

Total research and development expenses incurred in the six months ended June 30, 2013 decreased by $10.7 million, or 53%, as compared to the six months ended June 30, 2012. The $10.7 million decrease was primarily due to reduced external research and development costs of $9.2 million in the six months ended June 30, 2013. In addition, internal research and development costs decreased by $1.4 million in the six months ended June 30, 2013 as compared to the same period in 2012.

The $9.2 million decrease in our external research and development expenses for the six months ended June 30, 2013 as compared to the six months ended June 30, 2012, was due primarily to a $8.9 million decrease in costs incurred in connection with our Phase III clinical development program for Feraheme to treat IDA regardless of the underlying cause, which was completed in 2012 and a $0.4 million decrease in costs associated with our CKD-related clinical trials. In addition, manufacturing process development and material costs decreased by $0.3 million in the six months ended June 30, 2013 as compared to the six months ended June 30, 2012. During the six months ended June 30, 2012, we wrote-off pre-approval inventory which we no longer believed was suitable for sale.

The $1.4 million, or 19%, decrease in internal research and development expenses in the six months ended June 30, 2013 as compared to the six months ended June 30, 2012 was primarily attributable to the decrease in compensation and related benefits following our 2012 corporate restructurings, which resulted in lower headcount in our research and development departments, partially offset by incremental equity-based compensation expense for additional equity awards to new and existing employees.

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Selling, General and Administrative Expenses

Selling, general and administrative expenses for the six months ended June 30, 2013 and 2012 consisted of the following (in thousands):

	Six Months Ended June 30,
	2013		2012		$ Change			% Change
Compensation, payroll taxes and benefits	$	11,736	$	12,958	$	(1,222	)	-9	%
Sales and marketing consulting, professional fees, and other expenses	6,166		6,026		140			2	%
General and administrative consulting, professional fees and other expenses	8,448		7,129		1,319			19	%
Equity-based compensation expense	2,866		2,169		697			32	%
Total	$	29,216	$	28,282	$	934		3	%

Total selling, general and administrative expenses incurred in the six months ended June 30, 2013 increased by $0.9 million, or 3%, as compared to the six months ended June 30, 2012 for the following reasons:

· $1.2 million decrease in compensation, payroll taxes and benefits during the six months ended June 30, 2013 as compared to the same period in 2012 due to reduced headcount in our sales and marketing functions primarily related to the realignment of our sales territories during 2012;

· $0.1 million increase in sales and marketing consulting, professional fees, and other expenses during the six months ended June 30, 2013 as compared to the same period in 2012 primarily due to increased costs related to advertising and marketing materials and certain other general marketing costs incurred in connection with the preparation of the potential commercial launch of Feraheme in the broader IDA market, partially offset by decreased costs associated with a reduced headcount in our sales and marketing functions;

· $1.3 million increase in general and administrative consulting, professional fees and other expenses during the six months ended June 30, 2013 as compared to the same period in 2012 primarily due to $0.8 million of transaction and other costs related to the acquisition of the MuGard Rights, $0.7 million of increased consulting and legal activities, including costs relating to the Physician Payment Sunshine Act and related regulations, $0.6 million of increased accelerated depreciation expense related to certain leasehold improvements and furniture and fixtures associated with a portion of our principal executive offices to reflect our current estimate of useful lives of these assets, and $0.5 million of costs related to the closure of our Cambridge, Massachusetts manufacturing facility. These increased costs were partially offset by $1.6 million in termination fees which we paid during the second quarter of 2012 to our GastroMARK licensees in connection with the termination our license agreements with them; and

· $0.7 million increase in equity-based compensation expense for the six months ended June 30, 2013 as compared to the six months ended June 30, 2012 due primarily to the expense associated with equity awards to new and existing employees.

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Other Income (Expense)

Other income (expense) for the six months ended June 30, 2013 and 2012 consisted of the following (in thousands):

	Six Months Ended June 30,
	2013		2012			$ Change			% Change
Interest and dividend income, net	$	527	$	731		$	(204	)	-28	%
Gains on sale of assets	865		—			865			N/A
Gains (losses) on investments, net	32		(1,471		)	1,503			<(100	)%
Total	$	1,424	$	(740	)	$	2,164		<(100	)%

Other income (expense) for the six months ended June 30, 2013 increased by $2.2 million as compared to the six months ended June 30, 2012. This increase was primarily attributable to the non-recurring nature of the June 2012 $1.5 million loss realized on the sale of our then-remaining auction rate securities. Additionally, during the six months ended June 30, 2013, we recognized $0.5 million of gains in connection with the sale of Combidex ®, a molecular imaging agent which we are not actively pursuing development and $0.4 million gains on the sale of fixed assets related to our Cambridge, Massachusetts manufacturing facility. These increases in other income (expense) were partially offset by a decrease in interest and dividend income as the result of lower average cash balances during the first half of 2013 as compared to the same period in 2012.

Net Loss

For the reasons stated above, we incurred a net loss of $5.8 million, or $0.27 per basic and diluted share, for the six months ended June 30, 2013 as compared to a net loss of $9.1 million, or $0.43 per basic and diluted share, for the six months ended June 30, 2012.

Liquidity and Capital Resources

General

We finance our operations primarily from the sale of Feraheme/Rienso , including payments from our licensees, cash generated from our investing activities and the sale of our common stock. We expect to continue to incur significant expenses as we continue to manufacture, market and sell Feraheme/Rienso as an IV iron replacement therapeutic for use in adult CKD patients in the U.S., Canada, Switzerland and the EU, as we market and sell MuGard in the U.S. and as we further develop and seek regulatory approval for Feraheme/Rienso for the treatment of IDA in a broad range of patients in and outside of the U.S.

As of June 30, 2013, our investments consisted of corporate debt securities, U.S. treasury and government agency securities and commercial paper. We place our cash, cash equivalents and investments in instruments that meet high credit quality and diversification standards, as specified in our investment policy. Our investment policy also limits the amount of our credit exposure to any one issue or issuer, excluding U.S. government entities, and seeks to manage these assets to achieve our goals of preserving principal, maintaining adequate liquidity at all times, and maximizing returns.

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Cash, cash equivalents and investments as of June 30, 2013 and December 31, 2012 consisted of the following (in thousands):

	June 30, 2013		December 31, 2012		$ Change			% Change
Cash and cash equivalents	$	27,802	$	46,293	$	(18,491	)	-40	%
Short-term investments	184,611		180,750		3,861			2	%
Total	$	212,413	$	227,043	$	(14,630	)	-6	%

The $14.6 million decrease in cash, cash equivalents and investments as of June 30, 2013 from December 31, 2012 was primarily due to cash expended to fund our operations and working capital and cash used to purchase the MuGard Rights, partially offset by cash received from Feraheme sales, product sales and royalty payments from Takeda and interest income.

We expect that our cash, cash equivalents and investments balances, in the aggregate, will decrease slightly from their current balances during the remainder of 2013. Our expectation assumes our continued investment in the development of Feraheme and the commercialization of Feraheme and MuGard . We believe that our cash, cash equivalents and investments as of June 30, 2013 and the cash we currently expect to receive from sales of Feraheme , earnings on our investments, product sales and royalty payments from Takeda, and net product sales of MuGard will be sufficient to satisfy our cash flow needs for at least the next twelve months, including projected operating expenses related to our ongoing development and commercialization programs for Feraheme.

Cash flows from operating activities

During the six months ended June 30, 2013, our use of $10.3 million of cash in operations was attributable principally to our net loss of approximately $5.8 million, adjusted for the following:

· Non-cash operating items of $6.5 million including equity-based compensation expense, depreciation and amortization, amortization of premium/discount on purchased securities, gains on the sale of assets, a write-off of inventory, net gains (losses) on investments, and other non-cash items;

· An aggregate decrease in deferred revenues and other long-term liabilities of $4.0 million;

· An aggregate increase of $0.9 million in accounts receivable, prepaid assets and inventories; and

· An aggregate decrease of $6.1 million in accounts payable and accrued expenses.

Our net loss of $5.8 million was primarily the result of compensation and other expenses, commercialization expenses, including marketing and promotion costs, research and development costs, including costs associated with our clinical trials, and general and administrative costs, partially offset by net product sales and collaboration revenues.

Cash flows from investing activities

Cash used in investing activities in the six months ended June 30, 2013 was $8.8 million and was primarily attributable to the purchases of investments, partially offset by proceeds from the sales and maturities of our investments. In addition, in June 2013, we used $3.4 million of available cash and cash equivalents to purchase the MuGard Rights and related inventory.

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Contractual Obligations

On June 10, 2013, we entered into a lease agreement with BP Bay Colony LLC, or the Landlord, for the lease of certain real property located at 1100 Winter Street, Waltham, Massachusetts, or the Premises, for use as our principal executive offices. The initial term of the lease is five years and two months with one five-year extension term at our option. During the extension period, the base rent will be an amount agreed upon by us and the Landlord. In addition to base rent, we are also required to pay a proportionate share of the Landlord’s operating costs. The Landlord has agreed to pay for certain agreed-upon improvements (which we expect to be completed by September) and we will pay for any increased costs due to changes by us in the agreed-upon plans.

See Note M to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for additional information regarding our new facility-related agreements, including payment obligations under the initial term of our lease with the Landlord.

Off-Balance Sheet Arrangements

As of June 30, 2013, we did not have any off-balance sheet arrangements as defined in Regulation S-K, Item 303(a)(4)(ii).

Critical Accounting Policies

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements 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 related to product sales and collaboration agreements, product sales allowances and accruals, assessing investments for potential other-than-temporary impairment and determining values of investments, the fair value of our assets held for sale, contingent consideration, the impairment of long-lived assets, including intangible assets, accrued expenses 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 include revenue recognition and related sales allowances, valuation of investments, business combinations, intangible assets, contingent consideration, and equity-based compensation. For a detailed description, 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 and Note B to our condensed consolidated financial statements

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included in this Quarterly Report on Form 10-Q. Other than the following, there have been no material changes to our critical accounting policies discussed in our Annual Report.

Business Combination

On June 6, 2013, or the Acquisition Date, we acquired the MuGard Rights and inventory for total consideration of $17.4 million, consisting of a cash payment of $3.4 million and contingent consideration with an estimated fair value of $14.0 million. The transaction was accounted for as a business combination under the acquisition method of accounting, which requires, with limited exceptions, that assets acquired and liabilities assumed be recognized at their estimated fair values as of the Acquisition Date. Transaction costs are expensed as incurred. Any excess of the consideration transferred over the assigned values of the net assets acquired is recorded as goodwill.

The following table summarizes the estimated fair values of the assets acquired related to the MuGard Rights (in thousands):

Assets Acquired:
MuGard intangible asset	$	17,193
Inventory	241
Net identifiable assets acquired	$	17,434

We recorded $17.2 million of finite-lived intangible assets related to the MuGard Rights, which is being amortized using an economic consumption model over ten years, which represents our best estimate of the period over which we expect the majority of the asset’s cash flows to be derived. The fair value of the acquired MuGard intangible asset was determined using an income approach, including a discount rate of 19%. This approach begins with a forecast of the net cash flows expected to be generated by the asset over its estimated useful life. These cash flows are then adjusted to present value by applying an appropriate discount rate that reflects the risk factors associated with the cash flow streams. Some of the more significant estimates and assumptions inherent in the income approach include the following:

· The amount and timing of projected future cash flows, adjusted for the probability of marketing success;

· The discount rate selected to measure the risks inherent in the future cash flows; and

· An assessment of the asset’s life-cycle and the competitive trends impacting the asset.

Estimating the fair value of assets acquired in a business combination requires significant judgment. We believe the fair values assigned to the assets acquired are based on reasonable assumptions, however, these assumptions may be incomplete or inaccurate, and unanticipated events and circumstances may occur.

Intangible Assets and Impairment

Intangible assets represent the fair value of the MuGard Rights. We will amortize these assets using an economic consumption model over ten years. We believe this is the best approximation of the period over which we will derive the majority of value of the MuGard Rights. Intangible assets are reviewed for impairment at least annually and whenever facts or circumstances suggest that the carrying value of these assets may not be recoverable. Our policy is to identify and record impairment losses, if necessary, on intangible assets when events and circumstances indicate that the assets might be impaired and the

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undiscounted cash flows estimated to be generated by those assets are less than the carrying amounts of those assets.

Acquisition—Related Contingent Consideration

The acquisition of the MuGard Rights included contingent consideration to be paid to Access based on the occurrence of future events, in particular the payment of royalties to Access. Acquisition-related contingent consideration is initially recognized at fair value and then remeasured each reporting period, with changes in fair value recorded in our condensed consolidated statements of operations. We have estimated the fair value of the contingent consideration related to the acquisition of the MuGard Rights to be $14.0 million as of the date of the acquisition. The fair value of these contingent payments was calculated based on estimated sales and were discounted using a rate of 15%. Each quarter we will revalue the contingent consideration obligations associated with the acquisition of the MuGard Rights to their then fair value and record increases in the fair value as contingent consideration expense and record decreases in their fair value as a reduction of contingent consideration expense. Changes in contingent consideration expense result from changes in the assumptions regarding probabilities of the estimated timing and amount of royalty payments to Access and the discount rate used to estimate the fair value of the liability. Contingent consideration expense may change significantly as we gain more information related to sales of MuGard , impacting our assumptions. The assumptions used in estimating fair value require significant judgment. The use of different assumptions and judgments could result in a materially different estimate of fair value.

Impact of Recently Issued and Proposed Accounting Pronouncements

In February 2013, the Financial Accounting Standards Board issued an amendment to the accounting guidance for the reporting of amounts reclassified out of accumulated other comprehensive income, or AOCI. The amendment expands the existing disclosure by requiring entities to present information about significant items reclassified out of AOCI by component. In addition, an entity is required to provide information about the effects on net income of significant amounts reclassified out of each component of AOCI to net income either on the face of the income statement or as a separate disclosure in the notes of the financial statements. The amendment is effective for annual or interim reporting periods beginning after December 31, 2012. The adoption of this accounting pronouncement did not have a material impact on our financial statement disclosures. See Note J to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for additional information regarding AOCI.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

There have been no material changes with respect to the information appearing in Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk,” of our Annual Report.

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 decisions regarding required disclosure, and is recorded, processed, summarized and reported within the

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time periods specified in the Securities and Exchange Commission 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 (as such term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) that occurred during the three months ended June 30, 2013 that have materially affected, or that are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

Item 1. Legal Proceedings

A purported class action complaint was originally filed on March 18, 2010 in the U.S. District Court for the District of Massachusetts, entitled Silverstrand Investments et. al. v. AMAG Pharm., Inc., et. al., Civil Action No. 1:10-CV-10470-NMG, and was amended on September 15, 2010 and on December 17, 2010. The second amended complaint, or SAC, filed on December 17, 2010 alleged that we and our former President and Chief Executive Officer, former Chief Financial Officer, the then-members of our Board of Directors, and certain underwriters in our January 2010 offering of common stock violated certain federal securities laws, specifically Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended, and that our former President and Chief Executive Officer and former Chief Financial Officer violated Section 15 of such Act, respectively, by making certain alleged false and misleading statements and omissions in a registration statement filed in January 2010. The plaintiffs sought 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. On August 11, 2011, the District Court issued an Opinion and Order dismissing the SAC in its entirety for failure to state a claim upon which relief could be granted. A separate Order of Dismissal was filed on August 15, 2011. On September 14, 2011, the plaintiffs filed a Notice of Appeal to the U.S. Court of Appeals for the First Circuit, or the Court of Appeals. After briefing was completed by all parties, the Court of Appeals heard oral argument on May 11, 2012. On February 4, 2013, the Court of Appeals affirmed in part and reversed in part the District Court’s Opinion and Order, and remanded the case to the District Court. On February 19, 2013, we filed a Petition for Panel Hearing Rehearing or Rehearing En Banc , asking the Court of Appeals to reconsider its decision. On March 15, 2013, the Court of Appeals denied this petition. On March 22, 2013, we filed a Motion to Stay the Mandate remanding the case to the District Court pending review of the Court of Appeals’ February 4, 2013 decision by the U.S. Supreme Court. The Court of Appeals granted this Motion to Stay the Mandate on April 8, 2013. On June 13, 2013, we filed an appeal to the U.S. Supreme Court, or a writ of certiorari, seeking review of the First Circuit’s decision and to have that decision overturned. The plaintiffs have until August 16, 2013 to file their response.

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any generic version of ferumoxytol into the EU market until sometime between 2020 and 2022. This decision had no impact on our revenues for the year ended December 31, 2012. However, any future unfavorable outcome in this matter could negatively affect the magnitude and timing of future revenues, including royalties and milestone payments we may receive from Takeda pursuant to our collaboration agreement with Takeda. We continue to believe the patent is valid and intend to vigorously appeal the decision.

In July 2013, we submitted a Citizen Petition to the FDA regarding its December 2012 draft guidance providing product-specific bioequivalence recommendations for generic versions of ferumoxytol injection. In the Citizen Petition, we requested that the FDA (i) refrain from approving any abbreviated new drug application referencing Feraheme until certain post-market contract studies on Nulecit™, the only U.S. approved generic IV iron product, have been completed and have demonstrated that the FDA’s proposed pre-market approval standards for generic IV iron formulations are sufficient to ensure therapeutic equivalence, including comparable tissue distribution and no more in vivo labile iron leakage than the reference listed drug, or RLD; and (ii) require that any sponsors of proposed generic versions of Feraheme show that their products are equivalent to the RLD using (a) a comparative study in patients using clinical endpoints and (b) the additional assays that FDA has described for the proposed Nulecit™ post-market contract studies. We cannot predict when or if the FDA will respond to, or otherwise take any action with respect to, the Citizen Petition.

See Note M to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for additional information regarding our legal proceedings, including how we accrue liabilities for legal contingencies.

Item 1A. Risk Factors:

We are primarily dependent on the success of Feraheme/Rienso.

We currently derive and expect to continue to derive substantially all of our revenue from sales of Feraheme/Rienso by us in the U.S. and by our licensees, including Takeda Pharmaceutical Company Limited, or Takeda, outside of the U.S. and, therefore, our ability to become profitable is primarily dependent on our and our licensees’ successful commercialization and development of Feraheme/Rienso. Accordingly, if we are unable to generate sufficient revenues from sales of Feraheme/Rienso, or from milestone payments and royalties we may receive related to Feraheme /Rienso , we may never be profitable, our financial condition will be materially adversely affected, and our business prospects will be limited.

We intend to continue to dedicate significant resources to the development and commercialization of Feraheme/Rienso . However, we or Takeda may not be successful in our efforts to successfully commercialize Feraheme/Rienso in its current chronic kidney disease, or CKD, indication or to expand the approved indication of Feraheme/Rienso to include additional indications. Although we filed a supplemental New Drug Application, or sNDA, in the U.S. in December 2012 for Feraheme in patients with iron deficiency anemia, or IDA, who had failed to or could not use oral iron, the U.S. Food and Drug Administration, or the FDA, may not accept or approve our sNDA, or may require that we narrow the scope of our proposed indication. In addition, in June 2013, Takeda filed a Type II Variation, which is the European Union, or EU, equivalent of a U.S. sNDA, with the European Medicines Agency, or EMA, seeking marketing approval for Rienso for the treatment of IDA in adult patients. However, we have no control over Takeda’s interactions with the European regulatory agencies and we cannot be assured when and if the EMA will approve the filing. Any failure by us or Takeda to gain marketing approval for Feraheme/Rienso for the treatment of IDA regardless of the underlying cause could limit long-term shareholder value and adversely affect the future prospects of our business.

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We are not currently conducting or sponsoring research to expand our product development pipeline beyond Feraheme/Rienso. However, we are seeking additional business development transactions, such as in-licensing, acquisitions or collaborations that would be complementary to our business. For example, in June 2013, we acquired the rights to market and sell MuGard™ Mucoadhesive Oral Wound Rinse for the management of oral mucositis. Even if we continue to expand our product portfolio, our revenues and operations may not be as diversified as some of our competitors who may have numerous products or product candidates.

Competitors could file applications seeking a path to U.S. approval of a generic ferumoxytol.

Under Sections 505(c)(3)(E)(ii) and 505(j)(5)(F)(ii) of the Federal Food, Drug, and Cosmetic Act, or FDC Act, as amended by The Drug Price Competition and Patent Term Restoration Act of 1984, as amended, or the Hatch-Waxman Act, a new chemical entity, or NCE, that is granted regulatory approval may be eligible for five years of marketing exclusivity in the U.S. following regulatory approval. A drug can be classified as an NCE if the FDA has not previously approved any other drug containing the same active moiety, which is the molecule or ion responsible for the action of the drug substance. In 2009, the FDA determined that ferumoxytol did not qualify as an NCE and instead granted Feraheme a three-year “new use” market exclusivity, which expired in June 2012. In March 2010 and December 2012, we formally requested that the FDA reconsider its determination with respect to Feraheme’s NCE status. The FDA may deny our request for reconsideration of NCE status for Feraheme , in which case Feraheme may be subjected to early generic competition.

NCE status, if granted, would preclude approval during the exclusivity period of certain applications made under Section 505(b)(2) of the FDC Act, as amended by the Hatch-Waxman Act, or a Section 505(b)(2) new drug application, or NDA, and abbreviated new drug application, or ANDA, submitted by another company for another version of the subject drug; however, under governing law an application may be submitted four years after approval of the subject drug (even with a five year exclusivity period prohibiting approval) if it contains a certification of patent invalidity or non-infringement pursuant to Paragraph IV of the Hatch-Waxman Act, or the “Paragraph IV” certification procedure. In recent years, generic manufacturers have used Paragraph IV certifications extensively to challenge the applicability of Orange Book-listed patents on a wide array of innovative pharmaceuticals, and we expect this trend to continue. If we are not able to gain or exploit marketing exclusivity beyond the initial three year exclusivity period that expired in June 2012, we may face significant future competitive threats to our commercialization of Feraheme from other manufacturers, including the manufacturers of generic alternatives through the submission of Section 505(b)(2) NDAs and ANDAs. Further, even if Feraheme is granted NCE status and we are able to gain marketing exclusivity until June 2014, another company could challenge that decision and seek to overturn the FDA’s determination. Although costly, another company could also gain such marketing exclusivity under the provisions of the FDC Act, as amended by the Hatch-Waxman Act, if such company can, under certain circumstances, complete a human clinical trial process and obtain regulatory approval of its product.

In addition, in December 2012, the FDA published draft guidance regarding new draft product-specific bioequivalence for drug products containing ferumoxytol. The FDA generally publishes product-specific bioequivalence guidance after it has received an inquiry from a generic drug manufacturer about submitting an ANDA for the product in question; thus, it is possible that a generic drug manufacturer has approached the FDA requesting guidance about submitting an ANDA for ferumoxytol, the active ingredient in Feraheme , and that such an ANDA may be filed in the near future. Because the FDA may deny our request for reconsideration of NCE status for Feraheme and because the published bioequivalence guidance could encourage a generic entrant seeking a path to approval of a generic ferumoxytol to file an ANDA, we could face generic competition in the near-term or have to engage in extensive litigation with a generic competitor to protect our patent rights, either of which could adversely affect our business and results of operations. In July 2013, we filed a Citizen Petition in response to the

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FDA regarding its December 2012 draft guidance, however we cannot predict when or if the FDA will respond to, or otherwise take any action with respect to, the Citizen Petition. Companies that manufacture generic products typically invest far fewer resources in research and development than the manufacturers of branded products and can therefore price their products significantly lower than those branded products already on the market. Therefore, competition from generic IV iron products could limit our U.S. sales and any royalties we may receive from Takeda, which would have an adverse impact on our business and results of operations.

We are completely dependent on third parties to manufacture Feraheme/Rienso and any difficulties, disruptions or delays in the Feraheme/Rienso manufacturing process, including any transition to alternative source manufacturing facilities, could increase our costs, impact our ability to meet our or Takeda’s demand forecasts, or adversely affect our profitability and future business prospects.

In 2012, we ceased our manufacturing operations at our Cambridge, Massachusetts manufacturing facility. Consequently, we currently rely solely on our third-party contract manufacturers to manufacture Feraheme/Rienso for our commercial and clinical use in the U.S., the EU and Switzerland. We do not currently have an alternative manufacturer for our Feraheme/Rienso drug substance and finished drug product and we may not be able to enter into agreements with second source manufacturers whose facilities and procedures comply with current good manufacturing practices, or cGMP, regulations and other regulatory requirements on a timely basis and with terms that are favorable to us, if at all. Prior to ceasing our manufacturing operations in 2012, we manufactured Feraheme drug substance and drug product for use in the Canadian market at our Cambridge facility. Although we and Takeda are working to obtain regulatory approval of the manufacturing facilities at our current third-party contract manufacturers to produce Feraheme for sale in Canada, we do not currently have manufacturing facilities for this geography.

Our ability to have Feraheme/Rienso manufactured in sufficient quantities and at acceptable costs to meet our commercial demand and clinical development needs is dependent on the uninterrupted and efficient operation of our third-party contract manufacturing facilities. Any difficulties, disruptions or delays in the Feraheme/Rienso manufacturing process could result in product defects or shipment delays, recall or withdrawal of product previously shipped for commercial or clinical purposes, inventory write-offs or the inability to meet commercial demand for Feraheme/Rienso in a timely and cost-effective manner. Furthermore, our current third-party manufacturer does not manufacture for us exclusively and may exhaust some or all of its resources meeting the demand of other customers. Any potential manufacturing delays resulting from insufficient manufacturing capacity due to scheduling conflicts at our third-party manufacturers to produce sufficient quantities of Feraheme/Rienso to meet our demand forecasts or any other difficulties in our manufacturing process could result in our inability to meet our commercial demand for Feraheme/Rienso .

In addition, securing additional third-party contract manufacturers for Feraheme/Rienso will require significant time for transitioning the necessary manufacturing processes and for appropriate oversight and 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/Rienso in accordance with cGMP. If we are unable to have Feraheme/Rienso manufactured on a timely or sufficient basis because of these or other factors, we may not be able to meet commercial demand or our clinical development needs for Feraheme/Rienso or may not be able to manufacture Feraheme/Rienso in a cost-effective manner, particularly in light of the fixed price at which we are required to supply Feraheme/Rienso to Takeda under our License, Development and Commercialization Agreement, as amended in June 2012, or the Amended Takeda Agreement. As a result, we may lose sales, fail to generate increased revenues, suffer regulatory setbacks and/or we may lose money on our supply of Feraheme/Rienso to Takeda, any of which could have an adverse impact on our potential profitability and future business prospects.

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Our contract manufacturers may not be able to operate their manufacturing facilities in compliance with current good manufacturing practices, release specifications and other FDA and equivalent foreign regulations, which could result in a suspension of our contract manufacturers’ ability to manufacture Feraheme/Rienso, the loss of Feraheme/Rienso inventory, an inability to manufacture sufficient quantities of Feraheme/Rienso to meet U.S. or foreign demand, or other unanticipated compliance costs.

Our third-party contract manufacturing facilities are subject to cGMP regulations enforced by the FDA and equivalent foreign regulatory regulations and agencies through periodic inspections to confirm such compliance. Our contract manufacturers must continually expend time, money and effort in production, record-keeping and quality assurance and control to ensure that these manufacturing facilities meet applicable regulatory requirements. Failure to maintain ongoing compliance with cGMP or similar regulations and other applicable manufacturing requirements of various U.S. or foreign regulatory agencies could result in, among other things, the issuance of warning letters, fines, the withdrawal or recall of Feraheme/Rienso from the marketplace, total or partial suspension of Feraheme/Rienso production, the loss of Feraheme/Rienso inventory, suspension of the review of our current or any future sNDAs or equivalent foreign filings, enforcement actions, injunctions or criminal prosecution. 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/Rienso , and could have a severe adverse impact on our potential profitability and the future prospects of our business. If any U.S. or foreign regulatory agency inspects any of these manufacturing facilities and determines that they are not in compliance with cGMP or similar regulations or our contract manufacturers otherwise determine that they are not in compliance with these regulations, our contract manufacturers could experience an inability to manufacture sufficient quantities of Feraheme/Rienso to meet U.S. or foreign demand or incur unanticipated compliance expenditures.

We have also established certain testing and release specifications with the FDA and other foreign regulatory agencies. This release testing must be performed in order to allow the finished product to be used for commercial sale. If our finished product does not meet these release specifications or if the release testing is variable, we may not be able to supply product to meet our projected demand. In addition, variations in the regulatory approval of Feraheme/Rienso in the currently approved territories require that our third-party manufacturers follow different manufacturing processes and analytical testing methods. If we are unable to develop, validate, transfer or gain regulatory approval for the new release test, our ability to supply product to the EU will be adversely affected. Such setbacks could have an adverse impact on Feraheme/Rienso sales, our potential profitability and the future prospects of our business.

Significant safety or drug interaction problems could arise with respect to Feraheme/Rienso, which could result in restrictions in the Feraheme/Rienso label, recalls, withdrawal of Feraheme/Rienso from the market, an adverse impact on Feraheme/Rienso sales, or our need to alter or terminate current or future Feraheme development programs, any of which would adversely impact our future business prospects.

Significant safety or drug interaction problems could arise with respect to Feraheme/Rienso , including an increase in the severity or frequency of known problems or the discovery of previously unknown problems, and may result in a variety of adverse regulatory actions. In the U.S., under the Food and Drug Administration Amendments Act of 2007, the FDA has broad authority to force drug manufacturers to take any number of actions if safety or drug interaction problems arise, including, but not limited to the following:

· Requiring manufacturers to conduct post-approval clinical studies to assess known risks or signals of serious risks, or to identify unexpected serious risks;

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· Mandating labeling changes to a product based on new safety information; or

· Requiring manufacturers to implement a Risk Evaluation Mitigation Strategy where necessary to assure safe use of the drug.

Similar laws and regulations exist in countries outside of the U.S. In addition, previously unknown safety or drug interaction problems could result in product recalls, restrictions on the product’s permissible uses, or withdrawal of the product from the U.S. and/or foreign markets.

For example, in November 2010, following discussions with the FDA, we revised the Feraheme package insert, which includes essential information regarding the FDA-approved use of Feraheme , including, among other things, the approved indication, side effects, and dosage instructions, to include bolded warnings and precautions that describe events that have been reported during post-marketing review after Feraheme administration, including life-threatening hypersensitivity reactions and clinically significant hypotension. We directly alerted healthcare providers of the changes to the Feraheme package insert. In June 2011, we made further changes to the Feraheme package insert based on additional post-marketing data. These or any future changes to the Feraheme package insert could adversely impact our or Takeda’s ability to successfully compete in the IV iron market and could have an adverse impact on potential sales of Feraheme and our future business prospects.

The data submitted to both the FDA as part of our NDA and to the EMA as part of the Marketing Authorization Application for Feraheme/Rienso in the CKD indication was obtained in controlled clinical trials of limited duration. New safety or drug interaction issues may arise as Feraheme/Rienso is used over longer periods of time by a wider group of patients, some of whom may be taking numerous other medicines or by patients with additional underlying health problems. In addition, as we conduct and complete other clinical trials for Feraheme , new safety issues may be identified which could negatively impact our ability to successfully complete these studies, the use and/or regulatory status of Feraheme/Rienso for the treatment of IDA in patients with CKD in the U.S., EU or other territories, and the prospects for approval of future sNDAs, such as our December 2012 sNDA submission for Feraheme for the treatment of IDA regardless of the underlying cause. For example, the FDA may determine that our sNDA for our IDA global registrational program does not establish a sufficiently acceptable safety profile for the approval of a broader Feraheme label.

As more data become available and an increased number of patients are treated with Feraheme/Rienso , new safety or drug interaction issues may arise and require us to, among other things, provide additional warnings and/or restrictions on the Feraheme/Rienso package insert, including a boxed warning in the U.S. or similar warnings outside of the U.S., directly alert healthcare providers of new safety information, narrow our approved indications, alter or terminate current or future trials for additional uses of Feraheme , or even remove Feraheme/Rienso from the market, any of which could have a significant adverse impact on potential sales of Feraheme/Rienso or require us to expend significant additional funds. For example, in May 2013, Takeda recalled a single batch of Rienso from the Swiss market after becoming aware of four post-marketing adverse event reports relating to potential anaphylaxis/hypersensitivity reactions of varying severity following the administration of Rienso . One of these cases included a report of a fatality. The marketing authorization for Rienso and other IV iron formulations include, among their special warnings and precautions for use, an indication that the products may cause hypersensitivity reactions including serious and life-threatening anaphylactic/anaphylactoid reactions. The recalled batch was only distributed to and sold in Switzerland and the recall is limited to the specific batch in Switzerland. We and Takeda have completed an investigation regarding the specific Swiss batch of Rienso and the reported adverse events and Takeda has filed a report with the Swiss Agency for Therapeutic Products, commonly known as SwissMedic and the EMA. We are currently unable to predict when or if Rienso will be reintroduced into the Swiss market.

Our and Takeda’s ability to grow revenues from sales of Feraheme/Rienso could be limited if we or Takeda do not obtain approval, or if we or Takeda experience significant delays in our or Takeda’s

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efforts to obtain approval to market and sell Feraheme/Rienso for the treatment of IDA in a broad range of patients.

In December 2012, we submitted a sNDA to the FDA for Feraheme for the treatment of IDA in a broad range of patients. In addition, we expect that Takeda will file a Type II Variation with the EMA in 2013 seeking marketing approval for Feraheme/Rienso for the treatment of IDA in adult patients. Before applying for regulatory approval in the U.S. or foreign countries for the commercial marketing and sale of Feraheme/Rienso for the broad IDA indication, we have to demonstrate, through extensive human clinical trials, that Feraheme/Rienso is safe and effective for use in this broader patient population. Conducting these and other clinical trials is a complex, time-consuming and expensive process that requires adherence to a wide range of regulatory requirements. The FDA and foreign regulatory agencies have substantial discretion in the approval process and may decide that the results of our recently completed clinical trials are insufficient for approval or that Feraheme/Rienso is not effective or safe in indications other than the treatment of IDA in adult patients with CKD. For example, in our Phase III clinical trial in the broader patient population, Feraheme -treated patients experienced a 0.6% rate of related serious adverse events, or SAEs, as compared to a 0.2% rate of related SAEs from our current Feraheme label for the treatment of IDA in adult patients with 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 or EMA approval for their products. There is no guarantee that the FDA or EMA will determine that the results of our clinical trials in our global registrational program for Feraheme/Rienso in a broad range of patients with IDA will adequately demonstrate that Feraheme/Rienso is safe and effective in such a patient population to grant approval.

The FDA or EMA could also determine that our clinical trials and/or our manufacturing processes were not properly designed, were not conducted in accordance with applicable 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 clinical research organizations, or CROs, 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 application, which could adversely impact our ability to obtain marketing approval in the U.S. for Feraheme/Rienso in the broad IDA indication. 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 or prevent us from obtaining marketing approval for Feraheme/Rienso for the broad IDA indication. In addition, any failure by us or Takeda to obtain approval for the broad IDA indication could adversely affect the commercialization of Feraheme /Rienso in its current indication. If, for any of these or other reasons, we or Takeda do not obtain approval, or if we or Takeda experience significant delays in our or Takeda’s efforts to obtain approval to market and sell Feraheme /Rienso for the treatment of IDA in a broad range of patients, our cash position, our ability to increase revenues, our ability to achieve profitability, and the future prospects of our business could be materially adversely affected.

We may not be able to further expand our product portfolio by entering into additional business development transactions, such as in-licensing arrangements, acquisitions, or collaborations or if such arrangements are entered into they could disrupt our business, decrease our profitability, result in dilution to our stockholders or cause us to incur debt or significant additional expense.

As part of our business strategy to expand our product portfolio and achieve profitability, we are seeking to acquire or in-license other products that we believe would be complementary to our existing business. For example, in June 2013, we entered into a license agreement with Access Pharmaceuticals,

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Inc., or Access, under which we acquired the U.S. commercial rights to MuGard™ Mucoadhesive Oral Wound Rinse for the management of oral mucositis, or the MuGard Rights. We have limited experience with respect to these business development activities and there can be no assurance that we will be able to identify or complete any such transaction 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. We may not be successful in acquiring or in-licensing a product or product candidate that will provide us with commercial, development and/or financial synergies with Feraheme and our current organization such that we will be able to eliminate expenses either from our existing operations or from the cost structure of the acquired product.

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. Further, 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 could 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 . 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 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. If we are unable to successfully obtain rights to suitable products or if any acquisition or in-license arrangement we make is not successful, our business, financial condition and prospects for growth could suffer.

We may not realize the anticipated benefits of the acquisition of the MuGard Rights or any future acquisitions or product licenses and the integration of the MuGard Rights or any future acquisitions and any products or product candidates acquired or licensed may disrupt our business and management.

We have and we may in the future acquire or in-license additional commercialized specialty pharmaceutical products. For example, in June 2013, we entered into a license agreement with Access under which we acquired the MuGard Rights. The integration of the operations of acquired products or businesses, including MuGard , requires significant efforts, including the coordination of information technologies, sales and marketing, operations, manufacturing and finance. These efforts result in additional expenses and involve significant amounts of management’s time. In addition, we rely on Access, and may in the future have to rely on such other parties with whom we may enter into a future agreement, to perform certain regulatory filings, oversee certain functions, such as pharmacovigilance or the manufacture of the product we license from them, and any failure of Access or any other party to perform these functions for any reason, including ceasing doing business, could have a material effect on our ability to commercialize MuGard or any other future product we may acquire. We may not realize the anticipated benefits of the MuGard Rights or any future acquisition, license or collaboration, any of which involves numerous risks including the following:

· Difficulty in integrating the products or product candidates into our business;

· Entry into markets in which we have no or limited direct prior experience, including device markets, and where competitors in such markets have stronger market positions;

· Failure to achieve our strategic objectives, including successfully commercializing and marketing MuGard or any other products we may acquire;

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· Our ability to train our sales force, and the ability of our sales force, to incorporate successfully new products and devices, including MuGard , into their call points;

· Additional legal and/or compliance risk associated with the acquisition of MuGard or any other future product;

· Potential write-offs related to estimates we make in the accounting of acquisitions or product licenses, including MuGard , and any impact that may have on our quarterly financial results; and

· Disruption of our ongoing business and distraction of our management and employees from other opportunities or our core business functions, including Feraheme/Rienso .

If we cannot successfully integrate the MuGard business into our company, we may experience material negative consequences to our business, financial condition or results of operations. We cannot assure you that, following any such acquisitions, including MuGard , we will achieve the expected synergies to justify the transaction.

The success of Feraheme in the U.S. depends on our ability to maintain the proprietary nature of our technology.

We rely on a combination of patents, trademarks and copyrights 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 sufficient protection for our technology. The degree of protection afforded by patents for proprietary or licensed technologies or for future discoveries may not be adequate to preserve our ability to protect or commercially exploit those technologies or discoveries. The patents issued to us may provide us with little or no competitive advantage. In addition, there is a risk that others will independently develop or duplicate similar technology or products or circumvent the patents issued to us.

Our U.S. ferumoxytol patents are currently scheduled to expire in 2020. These and any other patents issued to us may be contested or invalidated. There has been substantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical and biotechnology industries. We may become a party to patent litigation and other proceedings, including interference and reexamination proceedings declared by the United States Patent and Trademark Office.

In addition, 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 financial and business costs, including the business cost attributable to the resulting distraction of our management. An adverse ruling in any litigation or administrative proceeding could prevent us from marketing and selling Feraheme , increase the risk that a generic version of Feraheme could enter the market to compete with Feraheme , limit our development and commercialization of Feraheme , or otherwise 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 an 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. Frequently, the unpredictable nature and significant costs of patent litigation leads the parties to settle to remove this uncertainty. Settlement agreements between branded companies and generic applicants may allow, among other things, a generic product to enter the market prior to the expiration of any or all of the applicable patents covering the branded product, either through the introduction of an authorized generic or by providing a license to the applicant for the patents in suit.

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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 licensees, collaborators, contract manufacturers, 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. Our inability to protect Feraheme through our patents and other intellectual property rights prior to their expiration could have a material adverse effect on our business, financial condition and prospects.

The success of Feraheme/Rienso abroad depends on our ability to protect our intellectual property rights and the laws of foreign countries may not provide the same level of protection as do the laws of the U.S.

The laws of foreign countries may not protect our intellectual property rights to the same extent as do the laws of the U.S. and therefore, in addition to similar risks to those describe above under the heading “ The success of Feraheme in the U.S. depends on our ability to maintain the proprietary nature of our technology, ” our intellectual property rights may be subject to increased risk abroad, including opposition proceedings before the patent offices for other countries, such as the European Patent Office, or the EPO, or similar adversarial proceedings, regarding intellectual property rights with respect to Feraheme/Rienso . For example, in July 2010, Sandoz GmbH, or Sandoz, filed with the EPO an opposition to one of our previously issued patents which covers ferumoxytol in the EU. In October 2012, at an oral hearing, the Opposition Division of the EPO revoked our European ferumoxytol patent. In December 2012, our notice of appeal was recorded with the EPO. The appeals process is costly and time-consuming and if it results in an unfavorable outcome to us, it could result in a loss of proprietary rights in the EU and may allow Sandoz or other companies to use our proprietary technology without a license from us, which may also result in a loss of future royalty or milestone payments to us, as well as the possibility that Takeda may determine that the terms of our agreement are no longer viable. We cannot predict the outcome of our appeal of the EPO decision. This or any future patent interference proceedings involving our patents may result in substantial costs to us, distract our management from day-to-day business operations and responsibilities, prevent us or Takeda from marketing and selling Feraheme/Rienso or increase the risk that a generic version of Feraheme/Rienso could enter the market to compete with Feraheme/Rienso . In countries where we do not have or have not applied for patents for ferumoxytol, such as in China, where we license certain development and commercial rights to Feraheme to 3SBio, Inc., 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. Any such limitation on our intellectual property rights would cause substantial harm to our competitive position and to our ability to develop and commercialize Feraheme/Rienso. Our inability to protect Feraheme/Rienso through our patents and other intellectual property rights in any territory prior to their expiration could have a material adverse effect on our business, financial condition and prospects.

Competition in the pharmaceutical and biopharmaceutical industries is intense. If we fail to compete effectively, our business and market position will suffer.

The pharmaceutical and biopharmaceutical industry is intensely competitive and subject to rapid technological change. Many of our competitors are large, well-known pharmaceutical companies and may benefit from significantly greater financial, sales and marketing capabilities, greater technological or competitive advantages, and other resources. Our competitors may develop products that are more widely accepted than ours and may receive patent protection that dominates, blocks or adversely affects our product development or business.

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The markets for our current products are highly sensitive to several factors including, but not limited to the following:

· The actual and perceived safety and efficacy profile of the available products;

· The ability to obtain appropriate insurance coverage and reimbursement rates and terms;

· Price competitiveness; and

· Product characteristics such as convenience of administration and dosing regimens.

The introduction by our competitors of alternatives to Feraheme/Rienso that would be, or are perceived to be, more efficacious, safer, cheaper, easier to administer, or provide more favorable insurance coverage or reimbursement could reduce our revenues and the value of our product development efforts.

Feraheme/Rienso may not receive the same level of market acceptance as competing iron replacement therapy products, in part because most of these products have been on the market longer and are currently widely used by physicians in the U.S. and abroad. In addition, certain of the IV iron products that we compete with are approved for the treatment of IDA in a broader group of patients than Feraheme/Rienso . We or Takeda may not be able to convince physicians and other healthcare providers or payers to switch from using the other IV iron therapeutic products to Feraheme/Rienso . If we or Takeda are not able to differentiate Feraheme/Rienso from other marketed IV iron products, our ability to maintain a premium price, our ability to generate revenues and achieve and maintain profitability, and our long-term business prospects could be adversely affected.

Feraheme currently competes with several IV iron replacement therapies in the U.S. In July 2013, Injectafer ® , which is known as Ferinject ® in Europe and is discussed below, was approved by the FDA for the treatment of IDA in adult patients who have an unsatisfactory response to oral iron or who have intolerance to oral iron, which is a broader indication than our current Feraheme indication. Injectafer’s U.S. approval or the approval of any other iron replacement product for a broader IDA indication than Feraheme , could adversely affect our efforts to market and sell Feraheme in the U.S. and our ability to generate additional revenues and achieve profitability.

Feraheme/Rienso also competes with a number of branded IV iron replacement and certain other iron dextran and iron sucrose products outside of the U.S., such as Ferinject ® (ferric carboxymaltose injection), which is an IV iron replacement therapy currently approved for marketing in 46 countries worldwide for the treatment of iron deficiency anemia where oral iron is ineffective or cannot be used. If Takeda is unable to convince physicians and other healthcare providers to switch from using the competing IV iron products to Feraheme/Rienso, our ability to generate revenues from royalties we may receive from Takeda will be limited and our operating results will be negatively affected. In addition, all other IV iron products currently approved and marketed and sold in the EU are approved for marketing to a broader group of patients with IDA. Feraheme/Rienso was approved only for use in adult CKD patients, which could put Feraheme/Rienso at a competitive disadvantage unless and until it receives approval for a broader indication outside of the U.S.

There are other companies commercializing products for the management or treatment of oral mucositis that may compete with MuGard including two marketed products: Kepivance ® (palifermin) an IV human growth factor which is marketed by Swedish Orphan Biovitrum, and Caphosol ® a supersaturated calcium phosphate artificial saliva used as an adjunct to other oral care which is marketed by Jazz Pharmaceuticals, PLC. In addition, there are several marketed products available which are indicated for the management of pain associated with oral mucositis including (i) Gelclair ® , which is

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marketed by DARA BioSciences, (ii) GelX Oral Gel which is marketed by Praelia Pharmaceuticals, Inc., and (iii) Episil which is marketed by Cangene BioPharma, Inc.

Our products may not be widely adopted by physicians, hospitals, patients, or healthcare payors, which would adversely impact our potential profitability and future business prospects.

The commercial success of our products depends upon the level of market adoption by physicians, hospitals, patients, and healthcare payors, including managed care organizations and group purchasing organizations, or GPOs. If our products do not achieve or maintain an adequate level of market adoption for any reason, our potential profitability and our future business prospects will be adversely impacted. Feraheme/Rienso and MuGard represent an alternative to other products and might not be adopted if perceived to be no safer, less safe, no more effective, less effective, no more convenient, or less convenient than currently available products. In addition, the pricing and/or reimbursement rates and terms of our products may not be viewed as advantageous to potential prescribers and payors as the pricing and/or reimbursement rates and terms of alternative products.

The degree of market acceptance of Feraheme/Rienso in the U.S. and abroad depends on a number of factors, including but not limited to the following:

· Our and Takeda’s ability to demonstrate to healthcare providers, particularly hematologists, oncologists, hospitals, nephrologists, and others who may purchase or prescribe Feraheme/Rienso , the clinical efficacy and safety of Feraheme/Rienso as an alternative to currently marketed IV iron products which treat IDA in CKD patients;

· Our and Takeda’s ability to convince physicians and other healthcare providers to use IV iron, and Feraheme/Rienso in particular, rather than oral iron, which is the current treatment of choice of most physicians for treating IDA in CKD patients;

· The actual or perceived safety and efficacy profile of Feraheme/Rienso as compared to alternative iron replacement therapeutic agents, particularly if unanticipated adverse reactions to Feraheme/Rienso result in further changes to or restrictions in the Feraheme/Rienso package insert, voluntary or involuntary product recalls and/or otherwise create safety concerns among potential prescribers;

· The relative level of available reimbursement in the U.S. for Feraheme from payors, including government payors, such as Medicare and Medicaid, and private payors as compared to the level of available reimbursement for alternative IV iron products;

· The relative price and/or level of reimbursement of Feraheme/Rienso outside of the U.S. as compared to alternative iron replacement therapeutic agents;

· The actual or perceived convenience and ease of administration of Feraheme/Rienso as compared to alternative iron replacement therapeutic agents, including iron administered orally; and

· The effectiveness of our and Takeda’s commercial organizations and distribution networks in marketing, selling and supplying Feraheme/Rienso .

The key component of our U.S. commercialization strategy is to market and sell Feraheme for use in non-dialysis adult CKD patients. The current U.S. non-dialysis CKD market is comprised primarily of three sites of care where a substantial number of CKD patients are treated: hematology and oncology centers, hospitals, and nephrology clinics. IV iron therapeutic products are not currently widely used by certain physicians who treat non-dialysis CKD patients in the U.S., particularly nephrologists, due to safety

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concerns and the inconvenience and often impracticability of administering IV iron therapeutic products in their offices. It is often difficult to change physicians’ existing treatment paradigms even when supportive clinical data is available. In addition, our ability to effectively market and sell Feraheme in the U.S. hospital market depends in part upon our ability to achieve acceptance of Feraheme onto hospital formularies. Since many hospitals and hematology, oncology and nephrology practices are members of GPOs, 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 these sites of care also depends in part on our ability to effectively promote Feraheme to and enter into pricing agreements with GPOs. If we are not successful in capturing a significant share of the U.S. non-dialysis CKD market or if we are not successful in securing and maintaining formulary coverage for Feraheme , our potential profitability as well as our long-term business prospects could be adversely affected.

We derive a substantial amount of our Feraheme revenue from a limited number of customers and the loss of one or more of these customers, a change in their fee structure, or a decline in revenue from one or more of these customers could have an adverse impact on our results of operations and financial condition.

In the U.S., we sell Feraheme primarily to wholesalers and specialty distributors and therefore a significant portion of our revenues is generated by a small number of customers. Four customers accounted for 92% of our total revenues during the six months ended June 30, 2013, and three customers accounted for 92% of our accounts receivable balance as of June 30, 2013. We pay these wholesalers and specialty distributors a fee for the services that they provide to us. Because our business is concentrated with such a small number of wholesalers and specialty distributors, we could be forced to accept increases in their fees in order to maintain the current distribution networks through which Feraheme is sold. Any increase in fees could have a negative impact on our current and future sales of Feraheme in the U.S. and could have a negative impact on the reimbursement rate an individual physician, hospital or clinic would realize upon using Feraheme . In addition, a significant portion of our U.S. Feraheme sales are generated through a small number of contracts with GPOs. For example, approximately 33% of our end-user demand during the period ended June 30, 2013 was generated by members of a single GPO with which we have contracted. As a result of the significant percentage of our end-user demand being generated by a single GPO, we may be at a disadvantage in future contract or price negotiations with such GPO and that GPO may be able to influence the demand for Feraheme from its members in a particular quarter through communications they make to their customers. In addition, the loss of, material reduction in sales volume to, or a significant adverse change in our relationship with any of our key wholesalers, distributors or GPOs could have a material adverse effect on our revenue in any given period and may result in significant annual or quarterly revenue fluctuations.

We depend, to a significant degree, on the availability and extent of reimbursement from third-party payors for the use of our products, and a reduction in the availability or extent of reimbursement could adversely affect our sales revenues and results of operations.

Our ability to successfully commercialize our products is dependent, in significant part, on the availability and extent of reimbursement to end-users from third-party payors for the use of our products, including governmental payors, managed care organizations and private health insurers. Reimbursement by third-party payors depends on a number of factors, including the third-party’s determination that the product is competitively priced, safe and effective, appropriate for the specific patient, and cost-effective. Third-party payors are increasingly challenging the prices charged for pharmaceutical products and have instituted and continue to institute cost containment measures to control or significantly influence the purchase of pharmaceutical products. If these entities do not provide coverage and reimbursement for our products or provide an insufficient level of coverage and reimbursement, physicians and other healthcare providers may choose to use alternative products, which would have an adverse effect on our ability to generate revenues.

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In addition, U.S. and many foreign governments continue to propose and pass legislation designed to reduce the cost of health care for patients. In the U.S., the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or the Health Care Reform Act, was enacted in March 2010 and includes certain cost containment measures including an increase to the minimum rebates for products covered by Medicaid programs, the extension of such rebates to drugs dispensed to Medicaid beneficiaries enrolled in Medicaid managed care organizations and the expansion of the 340B Drug Discount Program under the Public Health Service Act. In addition, the heightened focus on the health care industry by the federal government could result in the implementation of significant federal spending cuts, including cuts in Medicare and other health related spending in the near-term. For example, under the sequestration required by the Budget Control Act of 2011, as amended by the American Taxpayer Relief Act of 2012, Medicare payments for all items and services under Parts A and B incurred on or after April 1, 2013 have been reduced by up to 2%. Therefore, after adjustment for deductible and co-insurance, the reimbursement rate for physician-administered drugs including Feraheme , under Medicare Part B has been reduced from average selling price, or ASP, plus 6% to ASP plus 4.3%. Because the majority of our Feraheme business is through hematology/oncology clinics and out-patient hospital infusions centers, this reduction in the Medicare reimbursement payment for Feraheme may adversely impact our future revenues. The magnitude of the impact of these laws on our business is uncertain. Further, in recent years some states have also passed legislation to control the prices of drugs as well as begun a move toward managed care to relieve some of their Medicaid cost burden. While Medicare is the predominant payor for treatment of patients with CKD, Medicare payment policy, in time, 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. These and any future changes in government regulation or private third-party payors’ reimbursement policies may reduce the extent of reimbursement for our products and adversely affect our future operating results.

In January 2011, a prospective payment system for dialysis services provided to Medicare beneficiaries who have end-stage renal disease, or ESRD, became effective under which all costs of providing dialysis services are bundled together into a single prospective payment per treatment. This bundled approach to reimbursement has and will likely continue to alter the utilization of physician-administered drugs in the ESRD market as well as put downward pressure on the prices pharmaceutical companies can charge ESRD facilities for such drugs, particularly where alternative products are available. In the U.S., Feraheme is sold at a price that is substantially higher than alternative IV iron products in the dialysis setting, and as a result, the demand for Feraheme in the dialysis setting has largely disappeared. In addition, it is also possible that this “bundled” approach may be applied to specific disease states other than ESRD. For example, one large insurer in the U.S has attempted to bundle certain costs related to the treatment of cancer patients. Further changes in the Medicare reimbursement rate, which result in lower payment rates from payors, including Medicare payors, would further limit our ability to successfully market and sell our products in the U.S. In addition, in the U.S. hospital in-patient setting, Feraheme is reimbursed by Medicare under a diagnosis-related group payment system, which provides a per discharge reimbursement based on the diagnosis and/or procedure rather than actual costs incurred in patient treatments, thereby increasing the incentive for a hospital to limit or control expenditures. As a result, Feraheme has not been nor do we expect it to be broadly used in the hospital in-patient setting.

In countries outside of the U.S., market acceptance of Feraheme/Rienso 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 or allow sales of Feraheme/Rienso to be profitable in those countries. Any such limitations on the reimbursement for Feraheme/Rienso in countries outside of the U.S. would have an adverse impact on Takeda’s ability to

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generate product sales of Feraheme/Rienso in such territories, which would, in turn, limit the amount of royalties we may receive under our amended agreement with Takeda.

We are substantially dependent upon our collaboration with Takeda to commercialize Feraheme/Rienso in certain regions outside of the U.S., including Canada, Switzerland and the EU, and if Takeda fails to successfully fulfill its obligations, or is ineffective in its commercialization of Feraheme/Rienso in its licensed territories, or if our collaboration is terminated, our plans to commercialize Feraheme/Rienso outside of the U.S. may be adversely affected.

In March 2010, we entered into our initial agreement with Takeda, which was amended in June 2012, under which we granted exclusive rights to Takeda to develop and commercialize Feraheme/Rienso as a therapeutic agent in Europe, certain Asia-Pacific countries (excluding Japan, China and Taiwan), Canada, India and Turkey. We are highly dependent on Takeda for certain regulatory filings outside of the U.S. with respect to Feraheme/Rienso and the commercialization of Feraheme/Rienso outside of the U.S., including in Canada, Switzerland and the EU. If Takeda fails to perform its obligations under the Amended Takeda Agreement or is ineffective in its commercialization of Feraheme/Rienso in the agreed-upon territories, or if we fail to effectively manage our relationship with Takeda, our ability to and the extent to which we obtain regulatory approvals for Feraheme/Rienso and our Feraheme /Rienso commercialization efforts outside of the U.S. would be significantly harmed, which would have an adverse effect on milestone payments and royalties we may receive under the Amended Takeda Agreement. Further, if we fail to fulfill certain of our obligations under the Amended Takeda Agreement, Takeda has the right to assume the responsibility of clinical development and manufacturing of Feraheme/Rienso in the agreed-upon territories, which would increase the cost of and delay the Feraheme/Rienso development program outside of the U.S.

Takeda has the unilateral right to terminate the Amended Takeda Agreement under certain conditions, including without cause. If Takeda terminates the agreement and we chose to continue to commercialize Feraheme/Rienso in Takeda’s territories, we would be required to either enter into alternative arrangements with third parties to commercialize Feraheme/Rienso in Takeda’s territories, which we may be unable to do, or to increase our internal infrastructure, both of which would likely result in significant additional expense and the disruption or failure of commercial efforts outside of the U.S. In addition, such a termination would prevent us from receiving the milestone payments and royalties we may receive under the Amended Takeda Agreement.

In the U.S. there have been, and we expect there will continue to be, a number of federal and state legislative initiatives implemented to reform the healthcare system in ways that could adversely impact our business and our ability to sell our products profitably.

In the U.S., there have been, and we expect there will continue to be, a number of legislative and regulatory proposals aimed at changing the U.S. healthcare system. For example, the Health Care Reform Act contains a number of provisions that significantly impact the pharmaceutical industry and may negatively affect our potential product revenues. Among other things, the Health Care Reform Act increased the minimum Medicaid drug rebates for pharmaceutical companies, extended the rebate provisions to Medicaid managed care organizations, and expanded the 340B Drug Discount Program under the Public Health Service Act. Substantial new provisions affecting compliance have also been added, which may require us to modify our business practices with healthcare providers and potentially incur additional costs. While we are continuing to evaluate these laws on and their potential impact on our business, these laws may adversely affect the pricing for our products in the U.S. or cause us to incur additional expenses and therefore adversely affect our financial position and results of operations.

In addition, various healthcare reform proposals have emerged at the state level in the U.S. We cannot predict the impact that newly enacted laws or any future legislation or regulation will have on us. We expect

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that there will continue to be a number of U.S. federal and state proposals to implement governmental pricing controls and limit the growth of healthcare costs. These efforts could adversely affect our business by, among other things, limiting the prices that can be charged for our products or the amount of reimbursement rates and terms available from governmental agencies or third-party payors, limiting the profitability of our products, increasing our rebate liability or limiting the commercial opportunity for our products , including their acceptance by healthcare payors.

Wholesaler, distributor and customer buying patterns, particularly those who are members of a GPO, 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 U.S. wholesalers and distributors, which vary from quarter to quarter. In addition, our contracts with GPOs require certain performance from the members of the GPOs such as growth over prior periods or certain market share attainment goals in order to qualify for discounts off the list price of our products and a GPO may be able to influence the demand for our products from its members in a particular quarter through communications they make to their customers. In the event wholesalers and distributors with whom we do business in the U.S. determine to limit their purchases of our products our product sales could be adversely affected. For example, in advance of an anticipated price increase, following the publication of our quarterly average selling price which affects the rate at which Feraheme is reimbursed, or a reduction in expected rebates or discounts, customers may order Feraheme in larger than normal quantities which could cause Feraheme sales to be lower in subsequent quarters than they would have been otherwise. Further, any changes in purchasing patterns, inventory levels, increases in product returns , delays in purchasing products or delays in payment for products by one of our distributors or GPOs could also have a negative impact on our revenue and results of operations.

Our inability to obtain raw and other materials used in the manufacture of Feraheme /Rienso could adversely impact our ability to manufacture sufficient quantities of Feraheme/Rienso, which would have an adverse impact on our business.

We and our third-party manufacturers currently purchase certain raw and other materials used to manufacture Feraheme/Rienso from third-party suppliers and at present do not have long-term supply contracts with most of these third parties. These third-party suppliers may cease to produce the raw or other materials used in Feraheme/Rienso or otherwise fail to supply these materials to us or our third-party manufacturers or fail to supply sufficient quantities of these materials to us or our third-party manufacturers in a timely manner for a number of reasons, including but not limited to the following:

· Unexpected demand for or shortage of raw or other materials;

· Adverse financial developments at or affecting the supplier;

· Regulatory requirements or action;

· An inability to provide timely scheduling and/or sufficient capacity;

· Manufacturing difficulties;

· Labor disputes or shortages; or

· Import or export problems.

If any of our third-party suppliers cease to supply certain raw or other materials to us or our third-party manufacturers for any reason we could be unable to manufacture Feraheme/Rienso in sufficient quantities, on a timely basis, or in a cost-effective manner until we are able to qualify an alternative source. For

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example, one of the key components in ferumoxytol is produced specifically for us by a third-party supplier and if our third-party supplier is no longer able to supply it to us we will be unable to manufacture Feraheme/Rienso until we are able to identify and qualify an alternative supplier. This or any other interruption in our third-party supply chain could adversely affect our ability to satisfy commercial demand and our clinical development needs for Feraheme/Rienso .

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 or our third-party manufacturers sometimes obtain raw or other 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 or other materials, we or our third-party manufacturers may not be able to obtain such materials of the quality required to manufacture Feraheme/Rienso from an alternative source on commercially reasonable terms, or in a timely manner, if at all.

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

If we or Takeda market or distribute Feraheme/Rienso or if we market or distribute MuGard in a manner that violates federal, state or foreign healthcare fraud and abuse laws, marketing disclosure laws or other federal, state or foreign laws and regulations, we may be subject to civil or criminal penalties.

In addition to FDA and related regulatory requirements in the U.S. and abroad, we are subject to extensive additional federal, state and foreign healthcare regulation, which includes but is not limited to, the Federal False Claims Act, the Federal Anti-Kickback Statute, the Foreign Corrupt Practices Act, and their state analogues, and similar laws in countries outside of the U.S., laws governing sampling and distribution of products, and government price reporting laws. 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. The Foreign Corrupt Practices Act and similar foreign anti-bribery laws generally prohibit companies and their intermediaries from making improper payments to non-U.S. officials for the purpose of obtaining or retaining business. Similar laws and regulations exist in many other countries throughout the world in which we intend to commercialize Feraheme /Rienso through Takeda and our other licensees. 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, state and foreign regulations. If we, our representatives, or our licensees, including Takeda, fail to comply with any of these laws or regulations, a range of fines, penalties and/or other sanctions could be imposed on us and/or Takeda, including, but not limited to, restrictions on how we and/or Takeda market and sell Feraheme /Rienso and how we market and sell MuGard , 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 operations.

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In recent years, several U.S. states have enacted legislation requiring pharmaceutical companies to establish marketing and promotional compliance programs or codes of conduct and/or to 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 foreign governments. In addition, as part of the Health Care Reform Act, the federal government has enacted the Physician Payment Sunshine Act and related regulations. Beginning in August 2013, manufacturers of drugs are required to capture information to allow for the public reporting of gifts and payments made to physicians and teaching hospitals. 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, time consuming and costly, 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 operations.

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

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

As a condition of reimbursement by various U.S. federal and state healthcare programs for Feraheme , we are required to calculate and report certain pricing information to U.S. federal and state healthcare agencies. For example, we are required to provide ASP information to the Centers for Medicare and Medicaid Services on a quarterly basis in order to compute Medicare Part B payment rates. Price reporting and payment obligations are highly complex and vary among products and programs. The calculation of ASP includes a number of inputs from our contracts with wholesalers, specialty distributors, GPOs and other customers. It also requires us to make an assessment of whether these agreements are deemed to be for bona fide services and that the services are deemed to be at fair market value in our industry and for our products. Our processes for estimating amounts due under these governmental pricing programs involve subjective decisions. 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. In addition, the Health Care Reform Act modified the rules related to certain price reports and expanded the scope of pharmaceutical product sales to which Medicaid rebates apply, among other things. 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. This uncertainty in the interpretation of the legislation increases the chances of an error in price reporting, which could in turn lead to a legal challenge, restatement or investigation. If we become subject to investigations, restatements, 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 operations.

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, we may not be profitable in the future, and if we do attain profitability, such profitability may not be sustainable. In the past, we have financed our operations primarily from the sale of our equity securities, cash from sales of Feraheme/Rienso , cash generated by our

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investing activities, and payments from our licensees. As of June 30, 2013, we had an accumulated deficit of approximately $462.5 million. Our losses were primarily the result of costs incurred in our efforts to manufacture, market and sell Feraheme/Rienso , including costs associated with maintaining our commercial infrastructure and marketing and promotion costs, research and development costs, such as costs associated with our clinical trials, and selling, general and administrative costs. We expect to continue to incur significant expenses as we continue to manufacture, market and sell Feraheme as an IV iron replacement therapeutic for use in adult CKD patients in the U.S., market and sell MuGard and as we further develop and seek marketing approval for Feraheme for the treatment of IDA in a broad range of patients. As a result, we will need to generate sufficient revenues in future periods to achieve and maintain profitability. We anticipate that the majority of any revenue we generate in the next twelve months will be from sales of Feraheme/Rienso as an IV iron replacement therapeutic agent for use in adult CKD patients in the U.S., royalties we may receive with respect to sales of Feraheme/Rienso in Canada, Switzerland and the EU under the Amended Takeda Agreement, and from sales of MuGard . We have never independently marketed or sold any products prior to Feraheme , and we may not be successful in marketing or selling Feraheme or MuGard and Takeda may not be successful in marketing or selling Feraheme/Rienso . If we or Takeda are not successful in marketing and selling Feraheme/Rienso , if revenues grow more slowly than we anticipate or if our operating expenses exceed our expectations, or if we are otherwise unable to achieve, maintain or increase profitability on a quarterly or annual basis, our business, results of operations and financial condition could be materially adversely affected and the market price of our common stock may decline.

We have limited experience independently commercializing a pharmaceutical product and no experience independently commercializing multiple products, and any failure on our part to effectively execute our Feraheme or MuGard commercial plans in the U.S. would have an adverse impact on our business.

Prior to our commercialization of Feraheme in the U.S., we had never independently marketed or sold a product as we had relied on our licensees to market and sell our previously approved products. We have an internal commercial infrastructure to market and sell Feraheme and MuGard in the U.S., and if we are unsuccessful in maintaining an effective commercial function with multiple products, integrating MuGard into our existing sales infrastructure, or experience a high level of employee turnover, then the commercialization of Feraheme or MuGard could be severely impaired. For example, we reduced our workforce in 2011 as part of an overall corporate restructuring, including certain positions within our commercial function, with further restructuring occurring in 2012. These workforce reductions or any future reductions or departures, could harm our ability to attract and retain qualified personnel, which could prevent us from successfully commercializing Feraheme or MuGard in the U.S., impair our ability to maintain sales levels and/or impair our ability to support potential sales growth and sales of Feraheme for any additional indications we may commercialize in the future. Any failure by us to successfully commercialize Feraheme or MuGard in the U.S. could have a material adverse impact on our ability to generate revenues, our ability to achieve profitability, and the future prospects for our business.

Our success depends on our ability to attract and retain key employees, and any failure to do so may be disruptive to our operations.

Because of the specialized nature of our business, our success depends to a significant extent on the continued service of our executive officers and on our ability to continue to attract, retain and motivate qualified executive, sales, technical operations, managerial, scientific, and medical personnel. We have entered into employment agreements with most of our current 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. 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.

Previously implemented workforce reductions could residually harm our ability to attract and retain qualified personnel. In addition, any restructuring plans we may initiate in the future may be disruptive to

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our operations and could harm our ability to attract and retain qualified key personnel. For example, cost saving measures may distract management from our core business, harm our reputation, or yield unanticipated consequences, such as attrition beyond planned reductions in workforce, increased difficulties in our day-to-day operations, reduced employee productivity and a deterioration of employee morale. Any workforce reductions could also harm our ability to attract and retain qualified executive, sales, technical operations, managerial, scientific, and medical personnel who are critical to our business. Furthermore, because we are currently operating with fewer employees and service providers, any further turnover, whether occurring as part of a restructuring plan or otherwise, could cause significant disruption if we are unable to implement or maintain a sufficient succession plan for certain personnel or departments. Any failure to attract, retain or replace qualified personnel could prevent us from successfully commercializing and developing our products, impair our ability to maintain sales levels and/or support potential sales growth.

Moreover, although we believe it is necessary to reduce the cost of our operations to improve our performance, these initiatives may preclude us from making potentially significant expenditures that could improve our competitiveness over the longer term. We cannot guarantee that any cost reduction measures, or other measures we may take in the future, will result in the expected cost savings, or that any cost savings will be unaccompanied by these or other unintended consequences.

We have limited experience independently distributing a pharmaceutical product, and our 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/Rienso and MuGard . We have contracted with Packaging Coordinators, Inc. (formerly Catalent Pharma Solutions, LLC to provide certain labeling, packaging and storage services for final U.S. and Canadian Feraheme drug product. In addition, we have contracted with Integrated Commercialization Services, Inc to be our exclusive third-party logistics provider to perform a variety of functions related to the sale and distribution of Feraheme in the U.S., including services related to warehousing and inventory management, distribution, chargeback processing, accounts receivable management and customer service call center management. If these or any future third-parties are unable to provide uninterrupted labeling, packaging and storage services or supply chain services, respectively, we may incur substantial losses of sales to wholesalers or other purchasers of our products.

In addition, the packaging, storage and distribution of our products in the U.S. and abroad requires significant coordination among our, Takeda, and Access’ manufacturing, sales, marketing and finance organizations and multiple third parties including our third-party logistics providers, packaging, labeling and storage 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 our products to meet U.S. or foreign commercial demand could 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 in a timely manner, could cause the distribution of our products to be delayed or interrupted, which would have an adverse effect on our business, financial condition and results of operations.

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

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We rely and intend to continue to rely on third parties, including CROs, third-party manufacturers, third-party logistics providers, packaging and labeling providers, wholesale distributors and certain other important vendors and consultants in the conduct of our business. 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 or suppliers. For example, our distributors, customers or suppliers may experience difficulty in obtaining the financial resources necessary to purchase inventory or raw or other materials, may begin to maintain lower inventory levels or may 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.

In addition, we have contracted and plan to continue to contract with certain third parties to provide certain services, including site selection, enrollment, monitoring, data management and other services, in connection with the conduct of our clinical trials and the preparation and filing of our regulatory applications. We have limited experience conducting clinical trials outside the U.S., and, therefore, we are also largely relying on third parties such as CROs to manage, monitor and carry out these clinical trials. 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 and satisfactory manner, if the quality and accuracy of our clinical trial data or our regulatory submissions are compromised due to poor quality or 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 and planned regulatory submissions both in and outside of the U.S may be delayed or terminated, which would adversely impact our ability to generate revenues from Feraheme/Rienso 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 magnitude of U.S. Feraheme and MuGard sales;

· The loss of a key customer or GPO;

· The impact of any pricing strategies we have implemented or may implement related to our products , including the magnitude of rebates and/or discounts we may offer, or changes in pricing by our competitors or a new entrant into the market;

· The introduction of new competitive products, such as Injectafer or generic versions of new or currently available drug therapies;

· Any expansion or contraction of the overall size of the IV iron market, which could result from a number of factors including but not limited to changes in treatment guidelines or practices related to IDA;

· Any changes to the mix of our business;

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

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· The timing and magnitude of Feraheme/Rienso milestone payments, product sales revenues and royalties we may receive from Takeda under the Amended Takeda Agreement;

· The initiation or outcome of any material litigation or patent challenges to which we are or become a party and the magnitude of costs associated with such litigation;

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

· The magnitude of costs incurred in connection with business development activities or business development transactions into which we enter;

· Changes in accounting estimates related to reserves on revenue, returns, or other accruals or changes in the timing and availability of government or customer discounts, rebates and incentives;

· Further asset write-downs related to property and equipment or assets held for sale;

· Changes in the actual or perceived safety or efficacy profile of our products, or products that compete with Feraheme/Rienso or MuGard that could cause customers to increase, reduce or discontinue their use of our products;

· The timing and magnitude of costs associated with the manufacture of Feraheme/Rienso , including costs of raw and other materials and costs associated with maintaining commercial inventory and qualifying additional manufacturing capacities and alternative suppliers;

· The timing and magnitude of costs associated with our ongoing and planned clinical studies of Feraheme/Rienso in connection with our pediatric program, our post-marketing commitments for the EMA and other regulatory agencies, our pursuit of additional indications and our development of Feraheme/Rienso in countries outside of the U.S;

· The costs associated with manufacturing batch failures or inventory write-offs due to out-of-specification release testing or ongoing stability testing that results in a batch no longer meeting specifications;

· Changes in reimbursement practices and laws and regulations affecting our products from federal, state and foreign legislative and regulatory authorities, government health administration authorities, private health insurers and other third-party payors; and

· The 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.

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 U.S. The preparation of these condensed consolidated financial

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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 associated with revenue recognition related to product sales and collaboration agreements, product sales allowances and accruals, assessing investments for potential other-than-temporary impairment and determining the values of investments, the fair value of our assets held for sale, contingent consideration, the impairment of long-lived assets, including intangible assets, accrued expenses, income taxes and equity-based compensation expense. We base our estimates on market data, our observance of trends in our industry, and various other assumptions that we believe to be reasonable under the circumstances. If actual results differ from these estimates, there could be a material adverse effect on our financial results and the performance of our stock.

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 materially affect our financial position and results of operations. For example during 2012, we revised our estimated Medicaid reserve rate, which resulted in a reduction of our estimated Medicaid rebate reserve related to prior Feraheme sales of $0.6 million. Further, during 2012, we reduced our reserve for product returns by approximately $2.2 million due to a lower than expected actual returns rate since the 2009 launch of Feraheme as well as a reduction in our expected rate of product returns in the future.

In addition, to determine the required quantities of Feraheme and the related manufacturing schedule, we also need to make significant judgments and estimates based on inventory levels, current market trends, anticipated sales, forecasts from our licensees, including Takeda, and other factors. Because of the inherent nature of estimates, there could be significant differences between our and Takeda’s estimates and the actual amount of product need. For example, the level of our access to wholesaler and distributor inventory levels and sales data in the U.S., 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 operations.

In connection with our June 2013 acquisition of the MuGard Rights we were and will continue to be required to make estimates related to the fair value of the asset and the related contingent consideration. These estimates require significant judgment and assumptions including but not limited to: estimating future cash flows from product sales and developing appropriate discount and probability rates. If these or any other related estimates made in connection with the acquisition of the MuGard Rights or any future acquisitions require adjustment in the future, our operating results could be negatively affected.

We and/or Takeda are subject to ongoing U.S. and foreign regulatory obligations and oversight of Feraheme/Rienso and MuGard, and any failure by us to maintain compliance with applicable regulations may result in several adverse consequences including the suspension of the manufacturing, marketing and sale of our products, the incurrence of significant additional expense and other limitations on our ability to commercialize our products.

We and/or Takeda are subject to ongoing regulatory requirements and review both in the U.S. and in foreign jurisdictions pertaining to the manufacture, labeling, packaging, adverse event reporting, storage, marketing, promotion and record keeping related to our products. Failure to comply with such regulatory requirements or the later discovery of previously unknown problems with our products or our third-party contract manufacturing facilities or processes by which we manufacture our products may result in restrictions on our ability to manufacture, market or sell our products, including potential withdrawal from

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the market. Any such restrictions could result in a decrease in our product sales, damage to our reputation or the initiation of lawsuits against us, Takeda, or our third-party contract manufacturers. We and/or Takeda may also be subject to additional sanctions, including but not limited to:

· Warning letters;

· Civil or criminal penalties;

· Suspension or withdrawal of regulatory approvals;

· Temporary or permanent closing of the facilities of our third-party contract manufacturers;

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

· Changes to the package insert of our products, such as potential limitations on the current dosage and administration of Feraheme/Rienso or IV irons as a class;

· Implementation of risk mitigation programs;

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

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

Any of the above sanctions could have a material adverse impact on our ability to generate revenues and to achieve profitability and cause us to incur significant additional expenses.

The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products. If we are found to have improperly promoted off-label uses, we may become subject to significant fines and other liability.

The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products. In particular, a product may not be promoted for uses that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. If we are found to have promoted such off-label uses, we may become subject to significant government fines and other related liability. For example, the U.S. government has levied large civil and criminal fines against companies for alleged improper promotion and has enjoined several companies from engaging in off-label promotion. The government has also required companies to enter into complex corporate integrity agreements and/or non-prosecution agreements that can impose significant restrictions and other burdens on the affected companies.

In addition, incentives exist under applicable U.S. law that encourage employees and physicians to report violations of rules governing promotional activities for pharmaceutical products. These incentives could lead to so called whistleblower lawsuits as part of which such persons seek to collect a portion of moneys allegedly overbilled to government agencies due to, for example, promotion of pharmaceutical products beyond labeled claims. Such lawsuits, whether with or without merit, are typically time consuming and costly to defend. Such suits may also result in related shareholder lawsuits, which are also costly to defend.

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

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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 $13.85 and $25.67 in the fifty-two week period through July 31, 2013. 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. and Takeda’s ability to successfully commercialize Feraheme/Rienso in licensed territories outside of the U.S.;

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

· Changes in or our failure to meet financial estimates published by securities analysts or our own publicly disclosed financial guidance;

· Increases or decreases in our operating expenses or our gross margin on our products;

· Developments in patents or other proprietary rights by or for the benefit of us or our competitors, such as the recent decision by the EPO regarding our European ferumoxytol patent or decisions regarding Feraheme’s NCE status or an ANDA filing by a generic entrant;

· The availability of reimbursement coverage for our products or changes in the reimbursement policies of U.S. or foreign governmental or private payors;

· Public announcements of U.S. or foreign regulatory actions with respect to our products or products or product candidates of our competitors;

· Actual or perceived safety concerns related to our products or products or product candidates of our competitors, including any actions taken by U.S. or foreign regulatory authorities in connection with such concerns, or any voluntary or involuntary product recalls;

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

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

· Cash milestones earned, if any, under the Amended Takeda Agreement;

· The initiation or outcome of any material litigation or patent challenges to which we are or may become a party;

· Significant collaboration, product or business acquisitions, joint venture or similar agreements by us or our competitors;

· Shareholder activism and attempts to disrupt our strategy by activist investors;

· General market conditions; and

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· Sales of large blocks of our common stock.

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, seven 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. If any of the analysts who cover us downgrade our stock or issue commentary or observations about us or our stock that are perceived by the market as negative, our stock price would likely decline rapidly. In addition, if these analysts cease coverage of our company, we could lose visibility in the market, which in turn could also cause our stock price to decline.

If our operating results do not meet our own publicly disclosed financial guidance our stock price could decline.

In 2013, we publicly provided financial guidance, including expected 2013 Feraheme/Rienso product sales, total revenue, estimated operating expenses, estimated cost of goods sold as a percent of sales, quarterly cash flow trajectory throughout 2013 and estimated year-end cash and cash equivalents balance. If, for any reason, we are unable to realize our expected revenue growth in 2013 and beyond, including as the result of a lower-than-anticipated impact of our 2013 Feraheme price increases, we may fail to realize our publicly announced revenue and year-end cash and cash equivalents balance guidance. If we fail to realize or if we change or update any element of our publicly disclosed financial guidance or other expectations about our business, our stock price could decline in value.

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 . Our long-term capital requirements will depend on many factors, including, but not limited to:

· Our ability to successfully commercialize Feraheme in the U.S. and Takeda’s ability to successfully commercialize Feraheme/Rienso in its licensed territories outside of the U.S.;

· The magnitude of U.S. Feraheme sales;

· The magnitude of Feraheme/Rienso sales and royalties we may receive from Takeda outside of the U.S.;

· Our ability to obtain regulatory approval for Feraheme/Rienso to treat IDA regardless of the underlying cause both within the U.S. and outside of the U.S., particularly in the EU;

· The success, costs and structure of any business or corporate development initiatives to bring additional products into our portfolio;

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· The outcome of and costs associated with any material litigation or patent challenges to which we are or may become a party;

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

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

· The timing and magnitude of costs associated with qualifying additional manufacturing capacities and alternative suppliers;

· Our ability to maintain successful collaborations with our licensees 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 as of June 30, 2013, combined with cash we currently expect to receive from sales of Feraheme/Rienso and MuGard, from earnings on our investments, and royalty payments we may receive from Takeda will be sufficient to finance our currently planned operations for at least the next twelve months. We may require additional funds or need to establish additional alternative strategic arrangements to execute a business development transaction. We may at any time seek funding through additional arrangements with collaborators 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.

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 senior to those of, and 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 and our results of operations, liquidity and financial condition.

As of June 30, 2013, we had $27.8 million in cash and cash equivalents and $184.6 million in investments. These investments are subject to general credit, liquidity, market and interest rate risks, which have been and may, in the future, be exacerbated by a U.S. and/or global financial crisis. We may realize losses in the fair value of certain of our investments or a complete loss of these investments if the credit markets tighten, which would have an adverse effect on our results of operations, liquidity and financial condition.

The condition of the credit markets remains 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

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investment rating agencies as of the valuation date. These ratings are subject to change. 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.

We are subject to increasingly complex corporate governance, public disclosure and accounting requirements that could adversely affect our business and financial results.

We are subject to changing rules and regulations of U.S. federal and state government as well as the stock exchange on which our common stock is listed. These entities, including the Public Company Accounting Oversight Board, the NASDAQ Stock Market, or NASDAQ, and the Securities and Exchange Commission, or SEC, have issued a significant number of new and increasingly complex requirements and regulations over the last several years and continue to develop additional regulations and requirements in response to laws enacted by Congress. Our efforts to comply with these requirements have resulted in, and are likely to continue to result in, an increase in our expenses and a diversion of management’s time from other business activities.

Our ability to use net operating loss carryforwards and tax credit carryforwards to offset future taxable income may be limited as a result of 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.” 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.

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

Proxy contests have been waged against many companies in the biopharmaceutical industry over the last few years. For example, in 2011, MSMB Capital Management LLC, or MSMB Capital, filed a preliminary consent solicitation statement with the SEC seeking to remove and replace most of our then-current directors with MSMB Capital’s nominees. The review, consideration and response to efforts by activist shareholders may require the expenditure of significant time and resources by us and may be a significant distraction for our management and employees. The impact of activist shareholders’ efforts due to these or other factors may undermine our business and have a material adverse effect on our results of operations. If faced with a proxy contest, we may not be able to successfully defend against the contest, which would be disruptive to our business.

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.

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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 public accounting firm, determine that our internal controls over our financial reporting are not effective, or we discover areas that need improvement in the future, or we experience high turnover of our personnel in our financial reporting functions, 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 public 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 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 SEC, NASDAQ or other regulatory authorities.

An adverse determination in any current or future lawsuits in which we are a defendant, including the class action lawsuit to which we are currently a party, could have a material adverse effect on us.

A purported class action complaint was originally filed on March 18, 2010 in the U.S. District Court for the District of Massachusetts, entitled Silverstrand Investments et. al. v. AMAG Pharm., Inc., et. al., Civil Action No. 1:10-CV-10470-NMG, and was amended on September 15, 2010 and on December 17, 2010. The second amended complaint, or SAC, filed on December 17, 2010 alleged that we and our former President and Chief Executive Officer, former Chief Financial Officer, the then-members of our Board of Directors, or Board, and certain underwriters in our January 2010 offering of common stock violated certain federal securities laws by making certain alleged false and misleading statements and omissions in a registration statement filed in January 2010. The plaintiffs sought 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. On August 11, 2011, the District Court issued an Opinion and Order dismissing the SAC in its entirety for failure to state a claim upon which relief could be granted. On September 14, 2011, the plaintiffs filed a Notice of Appeal to the U.S. Court of Appeals for the First Circuit, or the Court of Appeals. After briefing was completed by all parties, the Court of Appeals heard oral argument on May 11, 2012, and took the matter under advisement. On February 4, 2013, the Court of Appeals affirmed in part and reversed in part the District Court’s Opinion and Order, and remanded the case to the District Court. On February 19, 2013, we filed a Petition for Panel Hearing Rehearing or Rehearing En Banc , asking the Court of Appeals to reconsider its decision. On March 15, 2013, the Court of Appeals denied this petition. On March 22, 2013, we filed a Motion to Stay the Mandate remanding the case to the District Court pending review of the Court of Appeals’ February 4, 2013 decision by the U.S. Supreme Court. The Court of Appeals granted this Motion to Stay the Mandate on April 8, 2013. On June 13, 2013, we filed an appeal to the U.S. Supreme Court, or a writ of certiorari, seeking review of the First Circuit’s decision and to have that decision overturned. The plaintiffs have until August 16, 2013 to file their response. Whether or not the plaintiff’s appeal is 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 may also be the target of similar litigation in the future. Any future 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. Though we maintain liability insurance, if any costs or expenses associated with this or any other litigation exceed our insurance coverage, we may be forced to bear some or all of these costs and expenses directly, which could be substantial.

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Product liability lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our products.

The administration of our products to humans, whether in clinical trials or after approval for commercial use, may expose us to liability claims, whether or not our products are actually at fault for causing an injury. As Feraheme /Rienso is used over longer periods of time by a wider group of patients taking numerous other medicines or by patients with additional underlying health problems, the likelihood of adverse drug reactions or unintended side effects, including death, may increase. 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 also decrease demand for our products, subject us to product recalls or harm our reputation, cause us to incur substantial costs, and divert management’s time and attention.

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.

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 stockholders (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 our Board. These provisions include:

· The ability of our Board 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 and for proposals to be brought before our annual meeting of stockholders;

· The authority of our Board 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, or Section 203, 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

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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 Third Amended and Restated 2007 Equity Incentive Plan generally permits our Board 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.

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.

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

The following table provides certain information with respect to our purchases of shares of our stock during the three months ended June 30, 2013:

Period	Total Number of Shares Purchased (1)	Average Price Paid per Share		Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs (2)	Maximum Number of Shares that May Yet Be Purchased Under the Plans or Programs (2)

April 1, 2013 through April 30, 2013	96	$	21.68	—	—

May 1, 2013 through May 31, 2013	8,162	$	25.03	—	—

June 1, 2013 through June 30, 2013	67	$	20.57	—	—

Total	8,325	$	24.96	—	—

(1) Represents shares of our common stock withheld by us to satisfy the minimum tax withholding obligations in connection with the vesting of restricted stock units held by our employees.

(2) We do not currently have any publicly announced repurchase programs or plans.

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Item 6. Exhibits

(a) List of Exhibits

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Exhibit Number		Description

10.1	+	License Agreement between the Company and Access Pharmaceuticals, Inc. dated as of June 6, 2013 (Certain confidential information contained in this exhibit was omitted by means of redacting a portion of the text and replacing it with [***]. This exhibit has been filed separately with the SEC without the redaction pursuant to a Confidential Treatment Request under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended).
10.2	+	Quality Agreement between the Company and Packaging Coordinators, Inc. (formerly Catalant Pharma Solutions LLC) dated as of June 5, 2013 (which amends and supersedes the Quality Agreement filed as Exhibit C to the Commercial Packaging Services Agreement, dated May 29, 2009, by and between the Company and Catalent Pharma Solutions LLC, filed as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed July 1, 2009, file number 000-14732).
10.3	+*	Form of Incentive Stock Option Agreement for Company Employees under the Company’s Third Amended and Restated Equity Incentive Plan.
10.4	+*	Form of Non-Qualified Stock Option Agreement for Company Employees under the Company’s Third Amended and Restated Equity Incentive Plan.
10.5	+*	Form of Restricted Stock Unit Agreement for Company Employees under the Company’s Third Amended and Restated Equity Incentive Plan.
10.6	*	Form of Non-Qualified Stock Option Agreement - Non-Plan Inducement Grant by and between the Company and Greg Madison (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-8, filed August 7, 2013).
10.7	*	Form of Restricted Stock Unit Agreement - Non-Plan Inducement Grant by and between the Company and Greg Madison (incorporated by reference to Exhibit 4.2 to the Company’s Registration Statement on Form S-8, filed August 7, 2013).
10.8	*	Form of Non-Qualified Stock Option Agreement - Non-Plan Inducement Grant (incorporated by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-8, filed August 7, 2013).
10.9	*	Form of Restricted Stock Unit Agreement - Non-Plan Inducement Grant (incorporated by reference to Exhibit 4.4 to the Company’s Registration Statement on Form S-8, filed August 7, 2013).
10.10	+*	Form of Non-Qualified Stock Option Agreement for Non-Employee Directors under the Company’s Third Amended and Restated Equity Incentive Plan.
10.11	+*	Form of Restricted Stock Unit Agreement for Non-Employee Directors under the Company’s Third Amended and Restated Equity Incentive Plan.
10.12	+*	Employment Agreement dated June 20, 2013 between the Company and Steven Caffe, M.D.
10.13	+*	Employment Agreement dated July 22, 2013 between the Company and Carol Ann Satler, M.D., Ph.D.
10.14		Lease Agreement, dated as of June 10, 2013, by and between AMAG Pharmaceuticals, Inc. and BP BAY COLONY LLC (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed June 13, 2013, File No. 001-10865).
10.15		Assignment and Assumption of Lease, dated as of June 10, 2013, by and among AMAG Pharmaceuticals, Inc., Mortimer B. Zuckerman and Edward H. Linde, Trustees of 92 Hayden Avenue Trust under Declaration of Trust dated August 18, 1983 and Shire Human Genetic Therapies, Inc. (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed June 13, 2013, File No. 001-10865).
10.16	*	AMAG Pharmaceuticals, Inc. Third Amended and Restated Equity Incentive Plan (incorporated herein by reference to Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A, filed April 19, 2013, File No. 001-10865).

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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.
101	++	The following materials from AMAG Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, formatted in Extensible Business Reporting Language (XBRL), (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Operations, (iii) Consolidated Statements of Comprehensive Loss, (iv) Consolidated Statements of Cash Flows, and (v) Notes to Consolidated Financial Statements.

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

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

* Exhibits marked with a single asterisk reference management contracts, compensatory plans or arrangements.

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SIGNATURES

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

	AMAG PHARMACEUTICALS, INC.

	By:	/s/ William K. Heiden
		William K. Heiden
		President and Chief Executive Officer

	Date: August 7, 2013

	AMAG PHARMACEUTICALS, INC.

	By:	/s/ Scott A. Holmes
		Scott A. Holmes
		Chief Accounting Officer,
		Vice President of Finance and Treasurer

	Date: August 7, 2013

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EXHIBIT INDEX

Exhibit Number		Description

10.1	+	License Agreement between the Company and Access Pharmaceuticals, Inc. dated as of June 6, 2013 (Certain confidential information contained in this exhibit was omitted by means of redacting a portion of the text and replacing it with [***]. This exhibit has been filed separately with the SEC without the redaction pursuant to a Confidential Treatment Request under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended).
10.2	+	Quality Agreement between the Company and Packaging Coordinators, Inc. (formerly Catalant Pharma Solutions LLC) dated as of June 5, 2013 (which amends and supersedes the Quality Agreement filed as Exhibit C to the Commercial Packaging Services Agreement, dated May 29, 2009, by and between the Company and Catalent Pharma Solutions LLC, filed as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed July 1, 2009, file number 000-14732).
10.3	+*	Form of Incentive Stock Option Agreement for Company Employees under the Company’s Third Amended and Restated Equity Incentive Plan.
10.4	+*	Form of Non-Qualified Stock Option Agreement for Company Employees under the Company’s Third Amended and Restated Equity Incentive Plan.
10.5	+*	Form of Restricted Stock Unit Agreement for Company Employees under the Company’s Third Amended and Restated Equity Incentive Plan.
10.6	*	Form of Non-Qualified Stock Option Agreement - Non-Plan Inducement Grant by and between the Company and Greg Madison (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form S-8, filed August 7, 2013).
10.7	*	Form of Restricted Stock Unit Agreement - Non-Plan Inducement Grant by and between the Company and Greg Madison (incorporated by reference to Exhibit 4.2 to the Company’s Registration Statement on Form S-8, filed August 7, 2013).
10.8	*	Form of Non-Qualified Stock Option Agreement - Non-Plan Inducement Grant (incorporated by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-8, filed August 7, 2013).
10.9	*	Form of Restricted Stock Unit Agreement - Non-Plan Inducement Grant (incorporated by reference to Exhibit 4.4 to the Company’s Registration Statement on Form S-8, filed August 7, 2013).
10.10	+*	Form of Non-Qualified Stock Option Agreement for Non-Employee Directors under the Company’s Third Amended and Restated Equity Incentive Plan.
10.11	+*	Form of Restricted Stock Unit Agreement for Non-Employee Directors under the Company’s Third Amended and Restated Equity Incentive Plan.
10.12	+*	Employment Agreement dated June 20, 2013 between the Company and Steven Caffe, M.D.
10.13	+*	Employment Agreement dated July 22, 2013 between the Company and Carol Ann Satler, M.D., Ph.D.
10.14		Lease Agreement, dated as of June 10, 2013, by and between AMAG Pharmaceuticals, Inc. and BP BAY COLONY LLC (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed June 13, 2013, File No. 001-10865).
10.15		Assignment and Assumption of Lease, dated as of June 10, 2013, by and among AMAG Pharmaceuticals, Inc., Mortimer B. Zuckerman and Edward H. Linde, Trustees of 92 Hayden Avenue Trust under Declaration of Trust dated August 18, 1983 and Shire Human Genetic Therapies, Inc. (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed June 13, 2013, File No. 001-10865).
10.16	*	AMAG Pharmaceuticals, Inc. Third Amended and Restated Equity Incentive Plan (incorporated herein by reference to Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A, filed April 19, 2013, File No. 001-10865).

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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.
101	++	The following materials from AMAG Pharmaceuticals, Inc.’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, formatted in Extensible Business Reporting Language (XBRL), (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Operations, (iii) Consolidated Statements of Comprehensive Loss, (iv) Consolidated Statements of Cash Flows, and (v) Notes to Consolidated Financial Statements.

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

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

* Exhibits marked with a single asterisk reference management contracts, compensatory plans or arrangements.

Exhibit 10.1

[***] 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.

LICENSE AGREEMENT

This License Agreement (the “ Agreement ”), is made and entered into on June 6, 2013 (the “ Effective Date ”) by and between (i) AMAG Pharmaceuticals, Inc., a Delaware corporation, with its principal place of business located at 100 Hayden Ave., Lexington, MA 02421 (“ AMAG ”) and (ii) Access Pharmaceuticals, Inc., a Delaware corporation, with its principal place of business located at 2600 Stemmons Freeway, Suite 176, Dallas TX 75207 (“ Access ”) (AMAG and Access are each a “ Party ,” and collectively the “ Parties ”).

WHEREAS, Access has developed and owns or otherwise controls certain intellectual property rights related to the Device (as defined below);

WHEREAS, AMAG desires to obtain the rights and licenses set forth herein pertaining to the Device;

NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

ARTICLE 1
DEFINITIONS

1.1 Certain Defined Terms . Capitalized terms shall have the meaning set forth on Schedule A attached hereto.

ARTICLE 2
LICENSE

2.1 License Grant . Subject to the terms and conditions of this Agreement, Access, on behalf of itself and its Affiliates, hereby grants to AMAG and its Affiliates (i) an exclusive (even as to Access and its Affiliates), royalty-bearing license, with the right to grant sublicenses, to the Access Intellectual Property Rights in the Territory to use, import, have imported, offer for sale, sell, manufacture and Commercialize the Device for the treatment of all diseases or conditions of the oropharyngeal cavity, including but not limited to, mucositis (such uses are the “ Field ”), in the Territory and (ii) solely upon the occurrence of a Specified Event, a non-exclusive license, with the right to grant sublicenses, to make and have made the Devices anywhere in the world solely for sale and use in the Territory. The right of AMAG to grant sublicenses under this Section 2.1 is subject to the requirement that each such sublicense shall be in writing and shall include provisions (i) acknowledging that such sublicense is subject to the applicable license(s) granted hereunder, (ii) requiring each sublicensee to perform all applicable obligations of AMAG hereunder in the applicable portion of the Territory ( specifically including the obligation to make reports and keep and maintain records of sales to at least the same extent as required under this Agreement), (iii) allowing Access the same access and audit rights with respect to such records as permitted with respect to AMAG’s records hereunder, and (iv) prohibiting further sublicensing by the sublicensee. AMAG shall at all times remain responsible for the

performance of any of its sublicensees. AMAG shall provide an un-redacted copy of each sublicense it enters into to Access promptly following execution. This Agreement does not convey to AMAG any rights in any Access Intellectual Property Rights, Access Patent Rights or any other intellectual property rights of Access by implication, estoppel or otherwise except for the rights expressly granted in this Section 2.1. Title to the Access Intellectual Property Rights, Access Patent Rights and any other intellectual property rights of Access shall at all times remain vested in Access.

2.2 Ancillary Rights . Access hereby assigns to AMAG all of its right, title and interest (including the right to control access or content) in and to any and all (i) Device-related internet or social media portals or accounts including the domain names www.mugard.com, www.mugard.net, www.mugard.org and the MuGard Facebook page and (ii) intellectual property rights Controlled by Access and its Affiliates, including copyrights, in any and all sales training, and sales, marketing and promotional materials, samples, reprints, speaker kits and product labeling and packaging related to the Device in the Territory. For avoidance of doubt, as of the Effective Date, Access shall cease all Commercialization, marketing, promotion, sales and other public communication relating to the Device in the Territory, by whatever means or media, except as expressly agreed to in advance by AMAG.

2.3 Covenant Not to Compete . Each Party and its Affiliates hereby covenant and agree that during the Term, they will not, directly or indirectly, research, develop, market, sell or Commercialize, or assist in the development, marketing, sale or Commercialization of, any medical devices that directly compete with the Device for the treatment of any diseases or conditions of the oropharyngeal cavity, including but not limited to, Mucositis (a “ Competitive Device ”) in the Territory; including, providing consultative services, owning, managing, operating, participating in, controlling or being connected as a majority stockholder, partner, or otherwise with any Person that creates, develops, markets, sells or Commercializes a Competitive Device, within the Territory.

2.4 Exclusivity . Access hereby agrees that it shall not and it shall cause its Affiliates to not provide the Device to any Third Party if Access or such Affiliate knows or has reason to believe that the units of Device provided to such Third Party have been sold for use or used in the Territory. I n the event that Access learns or is notified that the Device is being imported into the Territory by any Third Party to whom Access or any of its Affiliates have directly or indirectly supplied Device without prior written authorization from AMAG (“ Diverted Product ”), Access and its Affiliates shall take such actions as are necessary to cease such importation, including by terminating agreements with any Third Party involved in the purchase, sale or distribution of such units of Diverted Product. Access further agrees that it shall not and it shall cause its Affiliates to not manufacture, offer for sale, sell or otherwise commercialize, alone or with or through a Third Party, within the Territory, a product that [***], that can be used (whether or not such use is in compliance with applicable permits, licenses, authorizations, and clearances required by any Governmental Authority) within the Field. For avoidance of doubt, the foregoing limitation shall not prevent or limit Access’s right to manufacture, offer for sale, sell or otherwise commercialize products that [***], for the treatment of diseases or conditions outside of the Field.

2.5 Diligence . AMAG shall use Commercially Reasonable Efforts to Commercialize the Device throughout the Territory during the Term in accordance with the terms and conditions set forth in this Agreement. Notwithstanding the foregoing, AMAG shall provide Access the opportunity to provide commercially reasonable input and suggestions into matters relating to the Commercialization of the Device in the Territory, and AMAG shall not unreasonably refuse to consider such input and suggestions. AMAG shall provide Access with a commercialization plan detailing AMAG’s projected activities to Commercialize the Device in the Territory (each, a “ Commercialization Plan ”) within ten (10) days after the end of the [***] with updated Commercialization Plans for each calendar year to be provided thereafter not later than March 1 of each such calendar year.

ARTICLE 3
LICENSE FEES AND ROYALTIES

3.1 Upfront Payments

(a) Effective Date Payment . In consideration of the rights, licenses, representations and warranties granted or made by Access herein, AMAG shall make aggregate payments to Access in the amount of Three Million Three Hundred Thousand U.S. Dollars ($3,300,000) within five (5) Business Days after receipt of an invoice from Access, such invoice to be delivered on or after the Effective Date.

3.2 Royalties . As consideration for the rights granted pursuant to Section 2.1, AMAG shall pay to Access royalties on aggregate Net Sales of the Device in the Territory for each [***] as set forth below:

[]Net Sales in the Territory*		Royalty Rate

	[***]

For illustrative purposes, if [***], there are Net Sales of the Device in the amount of [***], AMAG will pay tiered royalties to Access, in the aggregate amount of [***].

3.3 Royalty Term . Royalties shall be payable on Net Sales of the Device beginning on the Effective Date and ending on the last to occur of (i) the expiration or termination of the

last Valid Claim of the Access Patent Rights to expire or terminate and (ii) the tenth (10 th ) anniversary of the First Commercial Sale of the Device in the Territory (the “ Royalty Term ”). After the expiration of the Royalty Term, the license granted pursuant to Section 2.1 herein shall become a fully paid-up, royalty-free and perpetual license in the Territory .

3.4 Royalty Reduction . The royalty rates shall be reduced to [***] of the rates set forth in Section 3.2 above on Net Sales of the Device in the Territory for any part of the Royalty Term occurring after the expiration or termination of the last Valid Claim of the Access Patent Rights to expire or terminate.

3.5 Royalty Off-Set . AMAG will be entitled to a royalty off-set equal to [***] of any amounts actually paid by AMAG to Third Parties in settlement (including a settlement by license) or final judgment of a Third Party claim that the composition of matter, use, manufacture or importation of the Device infringes the patent rights of such Third Party; provided that the application of such offset shall not reduce the royalties owed by AMAG to Access by more than [***] of the amount of any royalty payment due hereunder in any calendar quarter (excluding reductions taken in accordance with Section 5.1(a) and with any excess amount that is not recovered pursuant to this Section 3.5 being [***]. AMAG shall notify Access if AMAG’s royalty obligation is reduced pursuant to this Section 3.5 and AMAG shall include an explanation of the reduction in the applicable royalty report delivered pursuant to Section 3.6.

3.6 Royalty Reports; Payments . The royalty described in Section 3.2 shall be calculated and paid on a calendar quarter basis during the Term. AMAG shall furnish to Access a written report, within forty five (45) days after the end of each calendar quarter (or portion thereof, if this Agreement terminates during a calendar quarter), showing (a) the Net Sales of all Devices sold by AMAG and its Affiliates and Sublicensees in the Territory during the reporting period; (b) the calculation of royalties thereon; (c) the then aggregate Net Sales for Devices for [***]; and (d) the calculation of royalties payable under this Agreement for such calendar quarter (or portion thereof). Royalties shown to have accrued by each royalty report shall be due and payable on the date such royalty report is due. All payments to be made by AMAG hereunder will be made in U.S. dollars by wire transfer to such bank account as Access may designate. AMAG shall keep complete and accurate records in sufficient detail to enable the royalties payable hereunder to be determined for a period of at least three (3) years from the date of each payment of royalties.

3.7 Late Payments . In the event that any payment due under this Agreement is not made when due, the amount due shall accrue interest beginning on the [***] following the final date on which such payment was due, calculated at the annual rate equal to the prime interest rate reported in the Wall Street Journal for the due date, or, if lower, the maximum rate permitted by law, calculated from the due date until paid in full. Such payment when made shall be accompanied by all interest so accrued. Said interest and the payment and acceptance thereof shall not negate or waive the right of the party to whom payment is due to any other remedy, legal or equitable, to which it may be entitled because of the delinquency of the payment.

3.8 Inspections .

(a) During the term of the Agreement and for a period of three (3) years thereafter, AMAG, its Affiliates and Sublicensees will keep complete and accurate records in sufficient detail to permit Access to confirm the completeness and accuracy of the information presented in each report delivered pursuant to Section 3.6 and all payments due hereunder. AMAG, its Affiliates and Sublicensees will permit an independent, certified public accountant selected by Access and reasonably acceptable to AMAG, which acceptance will not be unreasonably withheld or delayed (the “ Auditor ”) to audit or inspect those records of AMAG that relate to Net Sales for one or more annual periods, for the sole purpose of verifying the: (i) accuracy of the reports required under Section 3.6 and royalties payable in respect of Net Sales for the period under review; and (ii) withholding taxes, if any, required by law to be deducted as a payment by AMAG in respect of such Net Sales. Such inspections shall be limited to the three (3) preceding calendar years and no period may be subject to such an inspection more than one time hereunder. Such inspections will be conducted during AMAG’s normal business hours at such place where such records are customarily kept, no more than once in any twelve (12) month period and upon at least thirty (30) days prior written notice by Access to AMAG. The Auditor will execute a reasonable written confidentiality agreement with AMAG and will disclose to Access only the amount and accuracy of payments reported and actually paid or otherwise payable under this Agreement and the specific details concerning any discrepancies. The Auditor will send a copy of the report to AMAG at the same time such report is sent to Access.

(b) In the event that the Auditor concludes that additional royalties were required for the annual period under review, the additional royalty payment will be paid within thirty (30) days of the date the Auditor delivers its report to the Parties so concluding that such payments were underpaid. The payment of additional royalties to Access shall bear interest as described in Section 3.7. The fees charged by the Auditor will be paid by Access unless the audit discloses an underpayment of royalties paid or payable by AMAG for the annual period under review by more than the greater of (i) [***] or (ii) [***], in which case AMAG shall pay (or reimburse Access for) the reasonable and documented fees and expenses charged by the Auditor.

ARTICLE 4

REGULATORY AND PATENT MATTERS

4.1 Governmental Clearance s .

(a) Access shall obtain and maintain all Governmental Clearances in the Territory concerning the Device and AMAG shall have the right to use and reference all such Governmental Clearances incident to and as an integral part of the License Grant set forth in Article 2 hereof.

(b) Access shall make determinations of whether additional regulatory submissions are necessary to be made to FDA. Access shall provide AMAG with a copy of any additional regulatory submission, including 510(k) premarket notifications submitted for modifications to the Device or other correspondence with FDA exploring whether a 510(k) notice is required for a given Device modification, for AMAG’s review and comment prior to submission. AMAG shall provide such comments to Access within

fifteen (15) days following its receipt of such materials from Access. Access shall provide AMAG with a copy of the final submission promptly after it is submitted to FDA.

(c) Access and its Affiliates hereby grant to AMAG a [***], right of use and reference for any and all data and information contained in any FDA Approvals or filings with FDA, including non-clinical data, and any other data and information required by AMAG in connection with the Commercialization of the Device in the Territory; provided that AMAG shall not seek to utilize such right of reference unless and until [***] and AMAG shall not thereafter seek to alter the scope and terms of the Regulatory Clearance for the Device within the Territory without Access’s prior written consent, not to be unreasonably withheld or delayed.

(d) Within five (5) Business Days after the Effective Date, Access and AMAG shall enter into an escrow agreement in substantially the form attached hereto as Schedule H (the “ Escrow Agreement ”). Subject to the terms and conditions set forth in the Escrow Agreement, Access will [***] and deposit with the escrow agent identified in the Escrow Agreement (the “ Escrow Agent ”) [***] attached hereto as Schedule F [***] to release from escrow [***] if a Release Event occurs pursuant to Section 4.9 of this Agreement. [***] .

4.2 Compliance with Applicable Laws - General.

(a) Each Party shall comply in all material respects with all Applicable Laws that relate to the performance of such Party’s obligations under this Agreement and, except as provided for herein, shall bear their own cost and expense of complying therewith.

(b) The termination or expiration of this Agreement shall not relieve either Party of its responsibility to comply in all material respects with any statutory or regulatory requirements associated with the Device(s).

(c) Each Party shall be responsible for compliance, as applicable, with FDA’s establishment registration and device listing requirements set forth in 21 C.F.R. Section 807.25.

(d) Access shall be responsible for compliance, as applicable, with FDA’s medical device reporting requirements set forth in 21 C.F.R. Part 803.25.

(e) Each Party shall be responsible for compliance, as applicable, with FDA’s corrections and removals requirements as set forth in 21 C.F.R. Part 806.

4.3 Good Manufacturing Practices.

(a) Access shall ensure that all Devices are designed and manufactured in material compliance with (i) FDA’s Good Manufacturing Practices,

which are codified in the Quality System Regulation (“ QSR ”) set forth in 21 C.F.R. Part 820, (ii) the Quality Agreement and (iii) the Supply Agreement.

(b) AMAG shall ensure that it conducts any QSR-related activities in substantial compliance with FDA’s requirements, as necessary. Without limiting the generality of the foregoing, such activities may include, among others, incoming inspections, warehousing and storage, Device handling and maintenance of distribution records. All Device Returns which are to be quarantined and marked in such a fashion as to not be confused with inventory for sale, and warehousing in a manner that prevents damage to Devices.

4.4 Device Complaints.

(a) Access shall be responsible for handling all complaints, inquiries and any medical or non-medical device reporting requirements associated with the Devices. Access or its Affiliates will be responsible for maintaining Device complaint files and for submitting reports to the FDA regarding such complaints. Access is responsible for complying with all Applicable Laws pertaining to the reporting of adverse device events or malfunctions, including FDA’s Medical Device Reporting requirements, as set forth at 21 C.F.R Part 803. AMAG shall cooperate fully with Access to enable Access to fulfill such requirements. Access shall provide AMAG with a copy of any response related to a request for information from FDA’s Office of Surveillance and Biometrics for AMAG’s review and comment prior to submission of the response. Access shall provide AMAG with a copy of the final response promptly after it is submitted to FDA.

(b) If AMAG receives any information regarding real or potential adverse reactions or malfunctions of the Device(s) or any information that might otherwise constitute a complaint about the Device(s), AMAG shall promptly provide to Access all information that it has concerning same. AMAG shall, at Access’s request, assist with the investigation of complaints by requesting reasonably obtainable follow-up information from its customers. Upon the request of AMAG, AMAG and Access shall promptly enter into a separate agreement to further specify the allocation of responsibilities set forth in this Section 4.4(b).

(c) In the event and to the extent that [***] manufacture, handling, storage or testing of the Devices facilities, [***], Access shall delegate to AMAG it responsibilities for complaint handling and MDR reporting under 21 C.F.R. Part 803, until [***]. Access shall cooperate fully with AMAG to enable AMAG to fulfill such requirements and shall promptly provide access to existing complaint files and MDRs. Once AMAG [***], all complaint handling and MDR reporting shall [***] with respect to Devices manufactured [***] but not with respect to Devices manufactured [***].

4.5 Quality Inspections By AMAG.

(a) Routine . Access and its Affiliates shall permit and facilitate AMAG (or an independent quality control auditor reasonably acceptable to Access), once each calendar year, for a period not to exceed three (3) days, during regular business hours and upon at least five (5) Business Days notice, access to inspect Access and the facilities where the Devices were managed or are manufactured, handled, stored or tested.

(b) For Cause . In addition, AMAG or its auditor shall have the right to inspect Access and the facilities where the Devices were managed or are manufactured, handled, stored or tested for a period not to exceed three (3) days, during reasonable business hours and upon at least four (4) Business Days notice where a substantial question concerning the quality of the Devices or manufacturing facilities or process has been raised by FDA or as a result of Device defect or Device-related claims of injury, including a follow up inspection to ensure implementation of any needed corrective action.

(c) During such inspections, AMAG or its auditor may observe all processes relating to the management or manufacture, storage, handling or testing of the Devices and all management, manufacturing, handling, storage and test records regarding the Devices to the extent necessary for, and for the sole purpose of, assessing Access’s compliance with the provisions of Sections 4.2, 4.3 and the product warranty set forth in Schedule E to this Agreement . Access shall provide reasonable and customary assistance during such inspections.

(d) AMAG and its auditor shall observe all rules applicable to visitors while on site at Access and its Affiliates. AMAG shall use reasonable efforts to ensure that such inspections do not unreasonably disrupt operations of the applicable facility, and acknowledges that in complying with its inspection obligations Access and its designees shall be entitled to protect the confidentiality of records, facilities and processes not related to the Device or the manufacturing or quality control processes relating to the Device .

(e) AMAG shall only be permitted to use an auditor who first executes a confidentiality agreement reasonably acceptable to Access and its Affiliates or designated third party manufacturers, as applicable.

(f) AMAG shall cause the auditor to provide Access and its Affiliates with a copy of any written materials reporting on the results and conclusions of such inspection contemporaneously with any such submission to AMAG.

(g) If an inspection pursuant to this Section 4.5 reveals that the facility used to manufacture Devices does not satisfy the requirements of Section 4.2 and Section 4.3 in all material respects, then AMAG will promptly provide to Access written notice of such fact, which notice will contain in reasonable detail the deficiencies alleged in the manufacturing facilities and, if practicable, those steps AMAG believes Access should undertake in order to remedy such deficiencies. Access will remedy such deficiencies

according to a mutually agreed plan to be established within [***] days after receipt of such written notice .

(h) In the event and to the extent that [***] manufacture, handling, storage or testing of the Devices facilities, whether directly or indirectly, then the provisions of Section 4.5(a)-(g) shall thereafter [***].

4.6 Device Recalls .

(a) If either Party (i) becomes aware of an event, incident or circumstance that has occurred which may result in the need for a recall or other removal of the Device or any lot or lots thereof from the market; (ii) becomes aware that a Governmental Authority is threatening or has initiated an action to remove the Device from the market; or (iii) is required by any Governmental Authority to distribute a “Dear Doctor” letter or its equivalent, regarding use of the Device, such Party shall promptly advise the other Party in writing with respect thereto, and shall provide to such other Party copies of all relevant correspondence, notices, and the like . The Parties will promptly confer to discuss such circumstances and to consider appropriate courses of action. The Parties shall mutually agree upon any corrective action with respect to the Device in the Territory; provided that in the event that they are unable to agree then Access shall have final authority to make all decisions relating to any recall, market withdrawal or other corrective action with respect to the Device in the Territory and shall be responsible for conducting any recalls or taking such other remedial action, and AMAG agrees, upon reasonable request by Access and [***], to assist with respect to such recalls or remedial actions .

(b) If Access decides to conduct a recall, market withdrawal or other corrective action with respect to the Device in the Territory Access will provide written notice to AMAG within twenty-four (24) hours of such decision, and a summary of the reason for and implementation of such action. Access shall provide such information as AMAG may reasonably require to prepare any additional customer notification of such recall, which notification shall be issued by AMAG.

(c) Any such recall shall be handled in accordance with the policies and procedures maintained by the recalling party. The recalling party shall submit to FDA, any necessary reports, as required under 21 C.F.R. Part 806, and shall be responsible for drafting any recall notifications with respect to the Devices. Access shall provide AMAG with a copy of any report for AMAG’s review and comment prior to submission. Access shall provide AMAG with a copy of the final report promptly after it is submitted to FDA.

(d) In the event of a recall, market withdrawal or other corrective action with respect to the Device in the Territory in accordance with Section 4.6, [***] shall be responsible for all costs and expenses of such recall, market withdrawl or other corrective action to the extent such recall, market withdrawal or other corrective action is caused by a breach of this Agreement or the Supply Agreement [***] or the failure of

[***], its Affiliates or contractors to comply with any FDA requirement and [***] shall, at its option, either [***] the Devices that are the subject of such action or [***] the Devices that are the subject of such action [***] within a reasonable time at its expense . [***] shall be responsible for the cost and expenses of any recall, market withdrawal or other corrective action with respect to the Device in the Territory to the extent that such recall, market withdrawal or other corrective action is caused by a breach of this Agreement by [***] or the failure of [***], its Affiliates or contractors to comply with any FDA requirement.

(e) During the term of this Agreement, AMAG shall maintain records of all sales of the Devices, including Devices sold, quantities and shipment dates, and customer information sufficient to adequately administer a recall, market withdrawal or correction and provide Access with such materials in the event and to the extent necessary to implement a recall, market withdrawal or correction. Immediately upon termination or expiration of this Agreement, AMAG shall provide Access with a copy of all distribution records relating to the Devices.

4.7 Governmental Inspections and Inquiries .

(a) Access and its Affiliates shall promptly, and in any event within [***] after the date of receipt of notice, notify AMAG in writing of, and shall provide AMAG with copies of, any correspondence and other documentation received or prepared by Access in connection with any of the following events to the extent necessary to meet the requirements of FDA or other Governmental Authority:

i. receipt of a regulatory letter, warning, recall notice, notice of FDA or other Governmental Authority in connection with the design, manufacture, storage, marketing, advertisement, sale and/or distribution of the Devices; and

ii. any FDA or other Governmental Authority comments relating to the Devices that may require a response or action by Access or its Affiliates.

(b) Without limiting the generality of the foregoing, in the event that AMAG or any of its agents receives a letter or comments from FDA or other Governmental Authority in connection with any of the Devices that requires a response or action by AMAG, Access shall promptly provide to AMAG any data or information required in preparing such response that relates to storage, marketing, advertising, sale or distribution of the Devices, and Access will cooperate fully with AMAG in preparing such response.

(c) In the event any facility that is used by Access or Affiliates to manufacture, store, market, advertise, distribute or sell any of the Devices is inspected by FDA or other Governmental Authority, Access shall notify AMAG promptly upon learning of such inspection and shall supply AMAG with copies of any correspondence

that relates to such inspection. AMAG may, at its election, send representatives to such facility and may observe any portion of such inspection that relates to the Device and provide input to Access. Access shall provide AMAG with a copy of any response related to such visit or inspection for AMAG’s review and comment prior to submission of the response. Access shall provide AMAG with a copy of the final response promptly after it is submitted to FDA or such other Governmental Authority.

4.8 AMAG Regulatory Requirements . AMAG shall at all times promote, advertise, market, distribute and sell the Device in accordance with all Applicable Laws.

4.9 Specified Events .

(a) In the event that a Specified Event occurs, (i) AMAG shall have the right, but not the obligation, to certify to the Escrow Agent that a Specified Event that is a Release Event has occurred and [***] and/or (ii) AMAG shall have the right, but not the obligation, [***]. Access shall promptly take such other actions as AMAG may reasonably request to assist AMAG in [***], including without limitation by providing the following:

[***]

(b) Access shall also grant AMAG the rights to [***] in cooperation with any Third Party manufacturer, including [***], for the manufacture of the Device, and shall issue a corresponding release to such Third Party to release it of any obligations that would interfere with [***]. Upon [***], the exclusive US license for [***] shall continue in effect for the full Term. Upon [***] the provisions of [***] shall continue in effect with all references in such Sections [***] being deemed [***] and all references in such Sections [***] being deemed [***] . For the avoidance of doubt, if AMAG exercises [***] rights in accordance with [***] then [***] shall not bear any obligations under this Agreement or the Supply Agreement in respect of [***].

· Access [***] addressed to Access or its Affiliates or its Third Party contract manufacturer within the time period established in a [***] (or any extension of such time period [***]) (“[***]”);

· Access or its Affiliates or its Third Party contract manufacturer [***] according to a [***] that is the subject of a notice delivered to Access pursuant to [***];

· [***];

· Access acquiesces to any [***], or if Access contests such action, such case is not dismissed within 60 days of its initial filing (“[***]”); or

· [***] and together with the [***], each a “ Release Event ” and collectively, the “ Release Events ”).

4.10 Patent Matters .

(a) Patent Maintenance . Access shall be responsible for the preparation, prosecution (excluding, any interferences, reissue proceedings and reexaminations) and maintenance of the Access Patent Rights [***]. Upon request by AMAG, Access shall provide AMAG with an update of the filing, prosecution and maintenance status for each of the Access Patent Rights. Access shall reasonably consult with, and will accommodate requests made by, AMAG with respect to the preparation, prosecution and maintenance of the Access Patent Rights in the Territory. Access shall provide to AMAG copies of any papers relating to the filing, prosecution or maintenance of the Access Patent Rights in the Territory promptly upon their being filed or received. Access shall not knowingly take any action during prosecution and maintenance of the Access Patent Rights that would materially adversely affect them (including abandonment or any reduction in claim scope), without AMAG’s prior consent. [***].

(b) Patent Enforcement . In the event that Access or AMAG becomes aware of a suspected infringement in the Territory of any Access Patent Right exclusively licensed to AMAG under this Agreement, or any such Access Patent Right is challenged in any action or proceeding (including any interferences, reissue proceedings or reexaminations), such Party shall notify the other Party promptly, and following such notification, the Parties shall confer. [***] shall have the first right, but shall not be obligated, to bring an infringement action with respect to such infringement at its own expense, in its own name, provided , that [***] keeps [***] reasonably informed of its progress and provides [***] with copies of any substantive documents related to such proceedings and reasonable notice of all such proceedings. [***] shall make reasonable efforts to assist [***], at [***] request and expense, in any action or proceeding being prosecuted if so requested, and shall lend its name to such actions or proceedings if reasonably requested by [***] or required by Applicable Law. If [***] recovers any damages or other sums in any such action, suit or proceeding or in settlement thereof, such damages or other sums recovered shall first be applied to all out-of-pocket costs and expenses incurred by the Parties in connection therewith, including, without limitation, attorney’s fees. If such recovery is insufficient to cover all such costs and expenses of both Parties, it shall be shared in proportion to the total of such costs and expenses incurred by each Party. If after such reimbursement any funds shall remain from such damages or other sums recovered, such funds shall be retained by [***], provided that

[***] shall receive out of any such remaining recovery received by[***] an amount equivalent to [***]. [***] shall notify [***] of its decision to exercise its right to enforce or defend the [***] as soon as possible, but not later than [***] following its discovery or receipt of notice of the alleged infringement. If (i) [***] notifies [***] that it will not [***] in accordance with this Section 4.4(b); (ii) [***] has exhausted all legal appeals with respect to causing the alleged infringement to cease or causing the Person alleging the infringement to forebear or (iii) [***] fails to bring an infringement action within [***] following its discovery or receipt of notice of the alleged infringement; or (iv) [***] is not reasonably diligent in pursuing an infringement action or diligently defending the validity or enforceability of [***] at issue and, after notice from [***], fails to exercise reasonable diligence in connection with such activities , then [***] shall have the right to pursue the alleged infringer or take control of any action initiated by, or being defended by, [***] at [***] own expense. Notwithstanding the foregoing, if [***] has not initiated an infringement or misappropriation action as described under (iii) above, or ceased to pursue such action, on the advice of outside patent counsel, then [***] agrees not to initiate such an action without [***] prior consent not to be unreasonably withheld or delayed (with the determination of reasonableness taking into account the costs of such litigation, its likelihood for success, the potential damages or settlement recovery) . In any such case, [***] will, wherever possible under Applicable Law, substitute [***] as party plaintiff for purposes of pursuing any alleged infringer, or as defendant for defending any [***]. If [***] recovers any damages or other sums in any such action, suit or proceeding or in settlement thereof, such damages or other sums recovered shall first be applied to all out-of-pocket costs and expenses incurred by the Parties in connection therewith, including, without limitation, attorneys fees. If such recovery is insufficient to cover all such costs and expenses of both Parties, it shall be shared in proportion to the total of such costs and expenses incurred by each Party. If after such reimbursement any funds shall remain from such damages or other sums recovered, such funds shall be retained by [***]. No settlement, consent judgment or other voluntary final disposition of any suit regarding [***] in the Territory may be entered into by AMAG or Access without the consent of the other Party, which consent shall not be unreasonably withheld or delayed.

ARTICLE 5
TRANSITION PERIOD

5.1 Transition Period . Access will perform the transition activities described in this Section 5.1 as soon as reasonably possible after the Effective Date. AMAG shall use reasonable efforts to support Access’s performance of such activities and shall otherwise cooperate in good faith with Access in connection therewith.

(a) Retained Sales; Retained Liabilities .

(i) For avoidance of doubt, as between the Parties, Access shall retain all rights and liabilities associated with Devices sold by or on behalf of Access either outside of the Territory at any time or within the Territory but prior to the

Effective Date (“ Retained Sales ”). Without limiting the foregoing, Access shall have the sole right to collect any and all amounts that are due and payable from Third Parties in connection with Retained Sales. Access shall retain sole responsibility for all costs, expenses, claims and liabilities associated with the manufacture, marketing, distribution, sale or use of the Device prior to the Effective Date (such amounts are collectively, the “ Retained Liabilities ”), including, liability for fees, services and claims arising under or related to any Third Party Agreements (including and such liability relating to Third Party Agreements that are assigned to AMAG to the extent incurred or accrued prior to such assignment), liability for all returns, rebates, credits, chargebacks, administrative fees, price adjustment claims and liabilities and all liabilities for damage or personal injury, including product liability claims, arising out of or relating to Retained Sales or the research, development and Commercialization of the Device by or on behalf of Access or any of its Affiliates.

(ii) AMAG Right to Cure and Offset. Notwithstanding the allocation of responsibility in Section 5.1(a)(i), in order to avoid confusion within the Territory, AMAG shall have the right, to be exercised if at all in AMAG’s sole discretion, to accept returns and to honor rebates, credits, price adjustments and similar claims and liabilities made or requested in connection with Retained Sales and Access hereby agrees (A) that Access shall reimburse AMAG for such costs incurred by AMAG in connection with such activities, including the amounts of such rebates, credits, price adjustments and other similar claims within thirty (30) days after receipt of an invoice therefor from AMAG and (B) that as an alternative to such reimbursement, AMAG shall be permitted to offset such costs against payments that become due hereunder from AMAG to Access.

(iii) Excess Load In. To the extent that Access (directly or with or through any Third Parties) shipped, distributed or sold a quantity of Devices within the Territory during the [***] period ending on the Effective Date that has an aggregate gross invoiced price in excess of [***] (such excess amount is the “ Excess Load In Charge ”) and will be subject to reimbursement or offset as set forth in this Section 5.1(a)(iii). Access hereby agrees (A) that Access shall reimburse AMAG in an amount equal to [***] of the Excess Load In Charge within [***] after receipt of an invoice therefor from AMAG and (B) that as an alternative to such reimbursement, AMAG shall be permitted to offset such costs against payments that become due hereunder from AMAG to Access.

(b) Commercial Agreements. Beginning on the Effective Date, and for a period of [***] thereafter, the Parties shall cooperate in good faith to (1) negotiate and effectuate the assignment of such Third Party Agreements to AMAG as AMAG may request, (2) to terminate such Third Party Agreements as AMAG may direct, and (3) to either maintain in effect for the benefit of AMAG (including that Access will exercise rights thereunder at AMAG’s direction) provided that AMAG performs any obligations thereunder or compensates Access for the cost of its performance, or make reasonable efforts to facilitate AMAG negotiation and entry into agreements with such Third Parties as AMAG may request, including that Access shall agree to terminate or waiver or modify its rights under any Third Party Agreements with such Third Parties with respect

to the Territory as necessary or convenient to facilitate such entry by AMAG. The Parties further agree that Access shall use reasonable efforts to maintain in effect the arrangement pursuant to which [***] provides [***] services for the Device in the Territory on behalf of Access in the same manner as such services have been provided for Access with only such modifications as AMAG shall direct, until the earlier of [***] or [***] after AMAG notifies Access of its desire to terminate such services (the “ [***] Transition Period ”); provided that: (1) such performance shall be for the benefit of AMAG and provided subject to AMAG’s policies and procedures provided to Access in writing, (2) Access receives a written commitment from [***] on or before the Effective Date in the form attached hereto as Schedule G ; and (3) Access shall promptly provide invoices for such services that are provided by [***] to Access and AMAG shall pay such invoices [***]. Notwithstanding anything herein to the contrary, to the extent that AMAG determines during the [***] Transition Period, that any of the Third Party Agreements identified in Schedule D to be assigned to AMAG or maintained by Access for the benefit of AMAG (as set forth in this Section 5.1(b)), could result in an actual or potential violation of the Healthcare Law, AMAG shall have the right to forego such assignment or maintenance of such Third Party Agreements, and AMAG and Access shall cooperate fully to facilitate the modification of such Third Party Agreement(s), or cancellation/termination and renegotiation of such Third Party Agreement(s). In no event shall AMAG be bound to accept assignment or maintenance (by Access) of any Third Party Agreement where it reasonably believes that such Third Party Agreement could result in an actual or potential violation of the Healthcare Law.

(c) Inventory. Access shall transfer to AMAG [***] of the Devices (not to exceed an aggregate of [***]) held by Access or its Affiliates (the “ Inventory ”); provided that such Inventory is in good, salable condition, has been manufactured, packaged, shipped and stored in compliance with all applicable regulations, the Regulatory Clearance and specifications and has no less than [***] of remaining shelf life. The price for such Inventory shall be [***]. AMAG shall pay Access for such Inventory within [***] Business Days after receipt of an invoice from Access, such invoice to be delivered on or after the Effective Date.

(d) Employees and Consultants. Access will identify employees and consultants retained by Access that have been involved in the research, development and Commercialization of the Device prior to the Effective Date and will facilitate introductions as requested by AMAG and will waive any non-compete or other restrictions or rights that Access has to limit or block AMAG from retaining or employing any such individuals as of and after the Effective Date in connection with its performance hereunder

(e) Further Assurances . Access agrees to take such actions, including executing and delivering such documents, as AMAG shall reasonably request on or after the Effective Date, to give effect to the terms set forth in this Agreement, including this Section 5.1. Access agrees to make its employees and advisors reasonably available to answer questions from and otherwise provide assistance and information to AMAG as AMAG may request to facilitate AMAG’s performance of its obligations hereunder.

(f) Quality Agreement and Supply Agreement . Within [***] after the Effective Date, the Parties shall enter into a supply agreement (the “ Supply Agreement ”) governing the supply of Product to AMAG in finished form for commercial use and for use as samples and within [***] after the Effective Date, the Parties shall enter quality agreement governing the quality control and quality assurance procedures thereon (the “ Quality Agreement ” and collectively the “ Quality and Supply Agreements ”) and a ny other operational agreements and procedures as deemed necessary by the Parties for such supply of the Product by Access or its designated Third Party contract manufacturer(s) to AMAG. The terms of such Quality and Supply Agreements shall be negotiated in good faith by the Parties in accordance with the terms of Schedule E . The Quality and Supply Agreements shall include, in addition to those terms specified in Schedule E , provisions that provide that if Access is unable to supply the Devices ordered by AMAG in accordance with the terms of the Quality and Supply Agreements, then Access shall use Commercially Reasonable Efforts to remedy the problem or secure an alternative source of supply within a reasonable time at no cost to AMAG, and any such alternative source of supply shall be on terms substantially similar with the terms of the Quality and Supply Agreements. If Access is unable to remedy the problem or secure an alternative source of supply in time to avoid an out of stock situation, then Access shall consult with AMAG and the Parties shall work together to remedy the problem. At that time, AMAG may at its option, and upon notice to Access, have the right to work directly with the existing source of the supply to remedy the problem or manufacture the Devices itself or through a Third Party. If AMAG notifies Access that AMAG will make the Devices itself or through a Third Party, Access shall (i) deliver to AMAG within ten (10) days media embodying or disclosing all technology and proprietary or intellectual property rights necessary to enable AMAG or its designee to manufacture Devices conforming with the Specifications; (ii) provide AMAG or its designee, upon request, with assistance in establishing a manufacturing line, and (iii) file as required any documentation with the FDA to be provided by AMAG to allow for the distribution of Devices produced by the Third Party in the Territory. AMAG shall continue to pay to Access the royalty due under Section 3.2 for all Devices manufactured by AMAG (or any Third Party selected by AMAG) and sold by AMAG pursuant to this Section 5.1(f); provided that if Access desires to make use of a Second Source for supply needs outside the Territory, the Parties shall use good faith efforts to agree [***], based on the volumes supplied for each such territory. AMAG shall require any Third Party AMAG designates to manufacture Devices pursuant to this Section 5.1(f) to agree in writing to observe the terms of the Quality and Supply Agreements relating to confidentiality and the manufacture of Devices. Notwithstanding any provision of this Section 5.1(f) to the contrary, in no case shall Access be required to pay AMAG in respect of any Devices purchased by AMAG from a Third Party operating a back-up manufacturing line established pursuant to this Section 5.1(f) or manufactured by AMAG or its Affiliates pursuant to this Section 5.1(f).

(g) Credits of Certain [***] Payments. [***]. In the event that [***] then Access shall be entitled to payment by the relevant [***] in respect of sales of the Device to the [***] covered by the [***]. In the event and to the extent that AMAG receives payments from such [***] in respect of sales of the Device to such [***] during

the period prior to the Effective Date, then AMAG shall credit and pay such amounts to Access . In the event and to the extent that Access receives chargebacks from third-party wholesalers relating to such [***] in respect of sales of the Device on behalf of AMAG to such [***] during the period after the Effective, Date then Access shall invoice AMAG and AMAG shall credit and pay such amounts to Access.

ARTICLE 6
TERM AND TERMINATION

6.1 Term . The term of this Agreement shall take effect as of the Effective Date and shall expire at the end of the Royalty Term unless sooner terminated as provided herein (the “ Term ”).

6.2 Termination . Notwithstanding anything in Section 6.1, this Agreement may be terminated at any time as follows:

(a) By either Party upon delivery of written notice to the other Party in the event of any breach by such other Party of any of such other Party’s material obligations under this Agreement, provided that such breach has not been cured within [***] after written notice thereof is given by the non-breaching Party to the breaching Party specifying the nature of the alleged, provided that, if a cure is not feasible within such [***] period, the cure period shall be extended (i) if the Parties agree that the breaching Party is using good faith reasonable efforts to cure such breach; or (ii) the existence of a material breach is the subject of an Arbitration Request.

(b) By AMAG at any time and without cause by providing at least one hundred and eighty (180) days prior notice of termination to Access or immediately upon written notice to Access if the FDA or any other Governmental Authority within the Territory enjoins on a permanent basis, the marketing, sale or use of the Device within the Field.

(c) By either Party at any time during the Term by providing written notice with immediate effect in the event that: (i) the other Party files in any court or agency pursuant to any statute or regulation of any state, country or jurisdiction, a petition in bankruptcy or insolvency or for reorganization or for a similar arrangement or for the appointment of a receiver or trustee of that Party or of its assets, other than the commencement of a proceeding under the Bankruptcy Code (11 U.S.C. § 101, et seq) or the appointment of a trustee in such a proceeding , or (ii) if the other Party proposes a written agreement of composition or extension of its debts generally, or (iii) if the other Party proposes or is a party to any voluntary dissolution or liquidation or is served with an involuntary petition for dissolution or liquidation under the Bankruptcy Code (11 U.S.C. § 101, et seq) that is not dismissed within sixty (60) days after the filing thereof, or (iv) if the other Party makes an assignment for the benefit of its creditors.

(d) At any time upon mutual written agreement of the Parties .

6.3 Effect of Termination . Upon termination of this Agreement pursuant to Section 6.2 herein:

(a) all rights and licenses granted to AMAG and its Affiliates under this Agreement will terminate, and AMAG and its Affiliates and Sublicensees will cease all use of Access Intellectual Property Rights; all agreements with Sublicensees shall provide that such sublicense agreements shall terminate upon any termination of this Agreement;

(b) AMAG shall, at Access’s written request and [***] promptly assign and transfer to Access all of AMAG’s right, title and interest in and to all Governmental Clearances, regulatory filings, clinical trial agreements and other data relating to the use, sale, offer for sale or importation of the Device in the Territory, including (1) data, materials, and information relating to non-clinical, pre-clinical and clinical activities and clinical trials; (2) samples of promotional, sales, marketing, and educational materials for the Device that describe the features or benefits of the Device, as such materials then currently exist that are related exclusively to the use, sale, offer for sale or importation of the Device (“ Promotional Materials ”) (each of which shall be transferred in any event within ninety (90) days after AMAG’s receipt of such request), in each case solely to the extent directly related to, and actually used by AMAG in connection with, the Device as of the effective date of termination. AMAG shall cooperate with Access in the assignment and transfer pursuant to this Section 6.3(b) to support ongoing Commercialization with minimal disruption and to the extent any materials described in this Section 6.3(b) are not transferable, AMAG shall use Commercially Reasonable Efforts to make such materials available to Access. Upon termination by Access pursuant to Section 6.2(a) or by AMAG pursuant to Section 6.2(b), (A) Access shall continue to have the right to use all aspects of the Promotional Materials (other than AMAG house marks) and to make derivative works based thereon, solely in connection with the Commercialization of the Device in the Territory; and (B) AMAG shall assign to Access those trademarks (if any) owned by AMAG and used solely in connection with the Commercialization of the Device and on the Promotional Materials as of the effective date of termination (excluding AMAG house marks) at Access’s cost, solely for the purpose of making, using, selling, offering for sale and importing such Devices in the Territory. AMAG shall own all right, title, and interest in and to any such Promotional Materials, including applicable copyrights and AMAG housemarks, but excluding trademarks assigned to Access as provided above ;

(c) AMAG shall have the right to sell its remaining supply of Devices in the Territory [***] following any such termination, subject to the payment of royalties due under Article 3 hereof;

(d) Nothing herein shall be construed to release either Party of any obligation that matured prior to the effective date of any termination. Either Party’s

liability for any uncontested charges, payments or expenses due to the other Party that accrued prior to the termination date shall not be extinguished by termination, and such amounts (if not otherwise due on an earlier date) shall be immediately due and payable on the termination date;

(e) Sections 1, 2.1 (with respect only to the conversion of the license granted on expiration of the Royalty Term as described in Section 3.3), 3.3 (with respect only to the conversion of the license granted in Section 2.1), 3.5, 3.8, 5.1(a), 6.3 (and the Sections referenced therein), 7.3, 7.4, 7.5, 8, 9.3, 9.5, 9.6 and 9.8 - 9.15 (inclusive) shall survive any termination or expiration of this Agreement .

6.4. AMAG’s Rights in Bankruptcy. All rights and licenses granted pursuant to any section of this Agreement are, and will be deemed to be, licenses of rights to “intellectual property” (as defined in Section 101(35A) of title 11 of the United States Code, 11 U.S.C. § 101, et seq (the “ Bankruptcy Code ”)) and of any similar provisions of applicable Laws under any other jurisdiction. Access agrees that AMAG, as a licensee of such rights and licenses under this Agreement, will retain and may fully exercise all of its rights and elections under the Bankruptcy Code (including under Section 365(n) of the Bankruptcy Code).

(a) Embodiments of Intellectual Property . AMAG will have all rights to embodiments of the intellectual property licensed to AMAG under this Agreement, as set forth in Section 365(n) of the Bankruptcy Code. AMAG’s rights to use and reference Governmental Clearances are essential to its rights to intellectual property and AMAG will retain and may fully exercise all such rights.

(b) Effect of Bankruptcy Filing . The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against Access under the Bankruptcy Code or analogous provisions of applicable law outside of the United States, then unless or until this Agreement is rejected or deemed rejected, Access or its trustee, pursuant to Section 365(n) of the Bankruptcy Code and upon the written request of AMAG:

(i) will perform this Agreement; or

(ii) will deliver all embodiments of such intellectual property, which, if not already in AMAG’s possession, will be promptly delivered to it upon AMAG’s written request therefor, to the full extent required by Section 365(n)(4) of the Bankruptcy Code.

(c) Reservation of Rights . Nothing in this Section 3.8 will limit or restrict, or will be construed to limit or restrict, the rights of AMAG under Section 365(n) of the Bankruptcy Code, all of which rights are hereby expressly reserved.

ARTICLE 7
REPRESENTATIONS, WARRANTIES, COVENANTS, LIMITATION OF LIABILITY, INDEMNIFICATION

7.1 Access Representations and Warranties . Access represents, warrants and covenants to AMAG as follows:

(a) Access is a corporation duly organized, validly existing and in good standing under the laws of state or jurisdiction in which it is incorporated, and it has full right and authority to enter into this Agreement and to grant the licenses and other rights to AMAG as herein described.

(b) This Agreement has been duly authorized by all requisite corporate action, and when executed and delivered will become a valid and binding contract of Access enforceable against Access in accordance with its terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium and other law affecting creditors’ rights generally from time to time if effect, and to general principles of equity.

(c) The execution, delivery and performance of this Agreement does not conflict with any other agreement, contract, instrument or understanding, oral or written, to which Access is a party, or by which it is bound, nor will it violate any law applicable to Access.

(d) All necessary consents, approvals and authorizations of all regulatory and governmental authorities and other persons or entities required to be obtained by Access in connection with the execution and delivery of this Agreement and the performance of its obligations hereunder have been obtained.

(e) The Patents identified on Schedule B are all of the Patent Rights Controlled by Access and its Affiliates as of the Effective Date that are necessary or useful for the Manufacture or Commercialization of the Device in the Territory. Access covenants that it will provide updated versions of Schedule B as needed so that such Schedule B is current and complete throughout the Term.

(f) Access and its Affiliates have disclosed or provided to AMAG and its Affiliates access to true and correct copies of all (i) all Governmental Clearances in the Territory, (ii) all safety data relevant to the Device, including all complaints, MedWatch reports and Medical Device Reports (“ MDRs ”), correction and removal reports and records, and recall records, (iii) all reports, warnings or notices from any and all Governmental Authorities related to the Device in the Territory, (iv) any and all notices from Third Parties regarding infringement or misappropriation of any intellectual property, (v) all non-clinical and clinical data related to the Device, including clinical data from completed, terminated or ongoing clinical trials, whether sponsored by Access or a Third Party, (vi) sales data, including the dates, quantities and prices for which the Device has been sold by or on behalf of Access in the Territory, customer lists, customer contracts, wholesale agreements, distribution agreement, Device Return rates, rebate agreements or policies, standard operating procedures, written policies, Promotional

Materials, training materials, forms and other relevant commercial records relevant to the Commercialization of the Device in the Territory, and (vii) any other information that would be material to assessing the clinical or commercial potential, or risks of Commercialization of the Device in the Territory.

(g) Neither Access nor any of its Affiliates has previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the Access Intellectual Property Rights in a manner inconsistent with the terms hereof. There is no agreement to which Access or any of its Affiliates is a party and by which it is bound that would conflict with or be breached by Access granting AMAG the licenses in Section 2.1 or assigning AMAG the rights assigned under Section 2.2 to AMAG.

(h) Neither Access nor any of its Affiliates are parties to any agreements with any Third Party relating to the Device (“ Third Party Agreement(s) ”), other than the Third Party Agreements expressly disclosed in Schedule D attached hereto, true and complete copies of which have been provided to AMAG, (i) except as provided in the Third Party Agreements, no Third Party has any right, title or interest in or to, or any license under, any Access Intellectual Property Rights, (ii) no rights granted by or to Access or its Affiliates or any requirements or obligations set forth under any Third Party Agreement conflict with this Agreement or any right or license granted to AMAG or its Affiliates hereunder, (iii) Access and its Affiliates are and at all times have been in compliance in all material respects with all Third Party Agreements, (iv) the Third Party Agreements are in full force and effect and, to its best knowledge, represent valid and enforceable obligations of the applicable Third Parties party thereto, (v) Access will, as set forth in Section 5.1(b): (1) assign to AMAG all of Access’s rights under those Third Party Agreements that are designated “To be Assigned to AMAG” on Schedule D , subject to Access retaining responsibility for any Retained Liabilities associated with such agreements, (2) terminate those Third Party Agreements that are designated “To be Terminated” on Schedule D and (3) continue in effect and for the benefit of AMAG those Third Party Agreements that are designated “To be Maintained” on Schedule D.

(i) Access has no knowledge of any (i) claims, judgments or settlements against Access or its Affiliates pending, or threatened, that invalidate or seek to invalidate the Access Patent Rights; (ii) pending litigation against Access or any Affiliate of Access that alleges that any of Access’s activities relating to the Device have violated or would violate, any of the intellectual property rights of any Third Party (nor has it received any written communication threatening such litigation.

(j) Access has no knowledge of any (i) claim, demand, suit, proceeding, arbitration, inquiry, investigation or other legal action of any nature, civil, criminal, regulatory or otherwise, pending or, threatened against Access or any of its Affiliates or (ii) judgment, injunction, consent decree, seizure, detention or settlement against or owed by Access or any of its Affiliates, in each case in connection with the Access Intellectual Property Rights, the Device, Commercialization activities related to

the Device, Third Party Agreements, or relating to the transactions contemplated by this Agreement.

(k) No royalty, milestone or other payment are or will become payable to any Third Party under any agreement entered into by and among Access or its Affiliates, and any Third Party, in connection with the development, Commercialization or use of the Device under and in accordance with this Agreement by AMAG or its Affiliates or Sublicensees or agents or distributors.

(l) Access and its Affiliates will (i) not amend or otherwise modify any Third Party Agreement or consent or waive rights with respect thereto in any manner that adversely affects (A) the rights granted to AMAG or AMAG’s Affiliates or Sublicensees hereunder or (B) Access’s ability to fully perform its obligations hereunder without the prior written consent of AMAG (such consent not to be unreasonably withheld or delayed); (ii) promptly furnish AMAG with true and complete copies of all amendments to the Third Party Agreements executed following the Effective Date; (iii) remain, and cause its Affiliates to remain, in compliance in all material respects with all Third Party Agreements; (iv) not terminate, take any action that would result in termination of (or fail to take any action the absence of which would result in termination of) any Third Party Agreement without the prior written consent of AMAG (such consent not to be unreasonably withheld or delayed); and (v) furnish AMAG with copies of all notices received by Access or its Affiliates relating to any alleged breach or default by Access or its Affiliates under any Third Party Agreement within five (5) Business Days after receipt thereof.

(m) Neither Access nor any of its Affiliates shall, directly or with or through any Third Parties, engage in any research and development activities, including any clinical development activities, concerning the Device in the Field: (1) inside the Territory or (2) outside of the Territory to the extent such activities could reasonably be anticipated to have a negative impact on the sale of Device within the Territory, the value of the rights granted hereunder to AMAG or AMAG’s ability to exercise such rights.

(n) Access hereby certifies that neither Access, nor any of its employees or agents involved in the research, development or Commercialization of the Device, has (1) ever been, is currently, or is the subject of a proceeding that has lead or could lead to that party becoming, as applicable, a Debarred Entity or Individual, an Excluded Entity or Individual or a Convicted Entity or Individual or (2) to the knowledge of Access, has engaged in any activities which are prohibited, or are cause for civil penalties, or grounds for mandatory or permissive exclusion, debarment or suspension by any Governmental Authority.

(o) Access is, has been and during the [***] Transition Period shall remain in compliance in all material respects with applicable Healthcare Laws and with the applicable policies of healthcare payers and insurers.

(p) Any and all samples of the Device have been distributed by Access exclusively for purposes of distribution as samples (not for sale or resale) to physicians or other health care professionals permitted to accept and/or receive samples in accordance with the legal requirements applicable to the distribution and provision of samples of the Device, and for no other purpose, and the distribution of such samples has been appropriately documented in compliance with all Applicable Laws. During the [***] Transition Period, any and all samples of the Device distributed by Access shall be exclusively for purposes of distribution as samples (not for sale or resale) to physicians or other health care professionals permitted to accept and/or receive samples in accordance with the legal requirements applicable to the distribution and provision of samples of the Device, and for no other purpose, and the distribution of such samples by Access shall be appropriately documented in compliance with all Applicable Laws.

(q) Access has not committed, engaged in or had committed on its behalf or authorized, any activities that would be reportable to any governmental authority under the so-called “sunshine provisions” in the Patient Protection and Affordable Health Care Act. During the [***] Transition Period, Access will not commit, engage in or authorize any activities that would be reportable to any governmental authority under the so-called “sunshine provisions” in the Patient Protection and Affordable Health Care Act.

(r) [***].

7.2 AMAG Representations and Warranties . AMAG covenants, represents and warrants to Access that as of the Effective Date:

(a) AMAG is a corporation duly organized, validly existing and in good standing under the laws of state in which it is incorporated, and it has full right and authority to enter into this Agreement and to accept the rights and licenses granted as herein described.

(b) This Agreement has been duly authorized by all requisite corporate action, and when executed and delivered will become a valid and binding contract of AMAG enforceable against AMAG in accordance with its terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium and other laws affecting creditors’ rights generally from time to time if effect, and to general principles of equity.

(c) The execution, delivery and performance of this Agreement does not conflict with any other agreement, contract, instrument or understanding, oral or written, to which AMAG is a party, or by which it is bound, nor will it violate any law applicable to AMAG.

(d) All necessary consents, approvals and authorizations of all regulatory and governmental authorities and other persons or entities required to be obtained by AMAG in connection with the execution and delivery of this Agreement and the performance of its obligations hereunder have been obtained.

(e) AMAG hereby certifies that neither AMAG, nor any of its employees or agents that will be involved in the Commercialization of the Device , has ever been, is currently, or is the subject of a proceeding that could lead to that party becoming, as applicable, a Debarred Entity or Individual, an Excluded Entity or Individual or a Convicted Entity or Individual.

7.3 Disclaimer . EXCEPT AS EXPRESSLY SET FORTH HEREIN, NEITHER ACCESS NOR AMAG MAKES ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT. THE REPRESENTATIONS AND WARRANTIES OF EACH OF ACCESS AND AMAG EXTEND ONLY TO THE OTHER PARTY. NEITHER PARTY WILL BE LIABLE FOR ANY CLAIM OR DEMAND AGAINST SUCH OTHER PARTY BY A THIRD PARTY, EXCEPT TO THE EXTENT PROVIDED IN SECTION 7.5.

7.4 Limitation of Liability . NOTWITHSTANDING ANYTHING IN THIS AGREEMENT OR OTHERWISE, NEITHER PARTY WILL BE LIABLE TO THE OTHER OR ANY THIRD PARTY WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT FOR ANY INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES HOWEVER CAUSED, UNDER ANY THEORY OF LIABILITY ; PROVIDED, HOWEVER, THAT THIS SECTION 7.4 WILL NOT APPLY TO (a) THE PARTIES’ INDEMNIFICATION RIGHTS AND OBLIGATIONS UNDER SECTIONS 7.5(a) AND 7.5(b) or BREACH OF CONFIDENTIALITY OBLIGATIONS UNDER ARTICLE 8 .

7.5 Indemnification .

(a) AMAG Indemnity . AMAG hereby agrees to indemnify and hold Access and its Affiliates, and their respective employees, directors, agents and contractors, and their respective successors, heirs and assigns and representatives (“ Access Indemnitees ”) harmless from and against all claims, liability, threatened claims, damages, expenses (including reasonable attorneys’ fees), suits, proceedings, losses or judgments, whether for money or equitable relief, of any kind, including death, personal injury, illness, product liability or property damage or the failure to comply with Applicable Law (collectively, “ Losses ”), arising from any Third Party claim to the extent due to (i) the Manufacture, Commercialization use or other disposition of the Device by AMAG [***], (ii) AMAG’s negligence or willful misconduct, or (iii) AMAG’s breach of this Agreement, except in each case in the event and to the extent that such Losses arise from (A) the negligence or willful misconduct of Access or (B) any breach of this Agreement by Access.

(b) Access Indemnity . Access hereby agrees to indemnify and hold AMAG, its Affiliates and Sublicensees, and their respective employees, directors, agents and contractors, and their respective successors, heirs and assigns and representatives (“ AMAG Indemnitees ”) harmless from and against all Losses arising from any Third Party claims to the extent due to (i) the Manufacture, Commercialization use or other disposition of the Device by Access [***], (ii) the negligence, or willful misconduct of

Access or (iii) any breach of this Agreement by Access, except in each case in the event and to the extent that such Losses arise from (A) the negligence or willful misconduct of AMAG or (B) any breach of this Agreement by AMAG.

(c) Indemnification Procedure . A claim to which indemnification applies under Section 7.5(a) or Section 7.5(b) will be referred to herein as a “ Claim ”. If any person or entity (each, an “ Indemnitee ”) intends to claim indemnification under this Section 7.5, the Indemnitee will notify the other Party (the “ Indemnitor ”) in writing promptly upon becoming aware of any claim that may be a Claim (it being understood and agreed, however, that the failure by an Indemnitee to give such notice will not relieve the Indemnitor of its indemnification obligation under this Agreement except and only to the extent that the Indemnitor is actually prejudiced as a result of such failure to give notice). The Indemnitor will have the right to assume and control the defense of such Claim at its own expense with counsel selected by the Indemnitor and reasonably acceptable to the Indemnitee; provided, however, that an Indemnitee will have the right to retain its own counsel, with the fees and expenses to be paid by the Indemnitee, if representation of such Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential differing interests between such Indemnitee and any other party represented by such counsel in such proceedings. If the Indemnitor does not assume the defense of such Claim as aforesaid, the Indemnitee may defend such Claim but will have no obligation to do so. The Indemnitee will not settle or compromise any Claim without the prior written consent of the Indemnitor, and the Indemnitor will not settle or compromise any Claim in any manner which would require any admission by the Indemnitee or impose any obligation on the Indemnitee , without the prior written consent of the Indemnitee, which consent, in each case, will not be unreasonably withheld. The Indemnitee will reasonably cooperate with the Indemnitor at the Indemnitor’s expense and will make available to the Indemnitor all pertinent information under the control of the Indemnitee, which information will be subject to Article 8.

ARTICLE 8
CONFIDENTIALITY

8.1 Confidentiality .

(a) Confidential Information . Except as expressly provided herein, each of the Parties agrees that, for itself and its Affiliates, and for as long as this Agreement is in effect and for a period of [***] thereafter, a Party and its Affiliates (the “ Receiving Party ”) receiving Confidential Information of the other Party or its Affiliates (the “ Disclosing Party ”) will (i) not disclose such Confidential Information to any Third Party without the prior written consent of the Disclosing Party, except for disclosures expressly permitted below, and (ii) not use such Confidential Information for

any purpose except those licensed or otherwise authorized or permitted by this Agreement.

(b) Exceptions . The obligations in Section 8.1(a) will not apply with respect to any portion of the Confidential Information that the Receiving Party can show by competent proof:

(i) is publicly disclosed by the Disclosing Party, either before or after it is disclosed to the Receiving Party hereunder;

(ii) was known to the Receiving Party or any of its Affiliates, without any obligation to keep it confidential or any restriction on its use, prior to disclosure by the Disclosing Party;

(iii) is subsequently disclosed to the Receiving Party or any of its Affiliates by a Third Party lawfully in possession thereof and without any obligation to keep it confidential or any restriction on its use;

(iv) is published by a Third Party or otherwise becomes publicly available or enters the public domain, either before or after it is disclosed to the Receiving Party; or

(v) has been independently developed by employees or contractors of the Receiving Party or any of its Affiliates without the aid, application or use of Confidential Information of the Disclosing Party.

(c) Authorized Disclosures . The Receiving Party may disclose Confidential Information belonging to the Disclosing Party to the extent (and only to the extent) such disclosure is reasonably necessary in the following instances:

(i) subject to Section 8.2, by either Party in order to comply with Applicable Law (including any regulations promulgated by the FDA, any securities laws or regulations or the rules of a securities exchange) and with judicial process, if in the reasonable opinion of the Receiving Party’s counsel, such disclosure is necessary for such compliance;

(ii) by either Party, in connection with prosecuting or defending litigation, making regulatory filings, and filing, prosecuting and enforcing patent applications and patents; and

(iii) by AMAG, to its Affiliates, potential and future collaborators (including Sublicensees), permitted acquirers or assignees under Section 9.1, subcontractors, investment bankers, investors, lenders, and each of their respective directors, employees, contractors and agents;

provided that (1) with respect to Section 8.1(c)(i) or 8.1(c)(ii), where reasonably possible and to the extent not prohibited by Applicable Law, the Receiving Party will notify the Disclosing Party of the Receiving Party’s intent to make any disclosure pursuant thereto sufficiently prior to making such disclosure so as to allow the Disclosing Party adequate time to take whatever action it may deem appropriate to protect the confidentiality of the information to be disclosed, and (2) with respect to Section 8.1(c)(iii), each of those named people and entities must be bound prior to disclosure by confidentiality and non-use restrictions at least as restrictive as those contained in this Article 8 (other than investment bankers, investors and lenders, who must be bound prior to disclosure by commercially reasonable obligations of confidentiality).

8.2 Terms of this Agreement . The Parties agree that the terms of this Agreement shall be treated as Confidential Information of both Parties, and thus may be disclosed only as permitted by Section 8.1(c) (i) or as otherwise provided herein .

8.3 Clinical Trial Results . Notwithstanding any other provision of this Agreement, the Parties agree that AMAG may publish summaries of the results of all non-clinical and clinical trials conducted by or on behalf of either Party, pertaining to the Device, and that Access shall not make, and shall not permit any other Person to make, any such publications or disclosure, without the prior written consent of AMAG, such consent not to be unreasonably withheld. AMAG shall provide Access with an advance copy of any such publication and will consider in good faith any comments relating thereto provided by Access within seven (7) Business Days after receipt by Access of the advance copy from AMAG.

8.4 Press Releases and Public Disclosures . Each Party agrees to coordinate timing of and not to issue any press release or other public statement disclosing information relating to this Agreement or the transactions contemplated hereby without the prior written consent of the other Party, other than with respect to the terms and conditions of this Agreement in accordance with Section 8.4, provided, however, that any disclosure which is required by Applicable Law (including the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended), or the rules of a securities exchange or the Securities and Exchange Commission or the securities regulators of any state or other jurisdiction, as reasonably advised by the disclosing Party’s counsel, may be made subject to the following. The Parties agree that any such required disclosure will not contain confidential business or technical information and, if disclosure of confidential business or technical information is required by Applicable Law or such rules or regulators, the Parties will use appropriate diligent efforts to minimize such disclosure and obtain confidential treatment for any such information which is disclosed to a governmental agency.

Each Party agrees to provide to the other Party a copy of any public announcement regarding this Agreement or the subject matter thereof as soon as reasonably practicable under the circumstances prior to its scheduled release. Except under extraordinary circumstances, each Party shall provide the other with an advance copy of any such announcement at least two (2) Business Days prior to its scheduled release. Each Party shall have the right to expeditiously review and recommend changes to any such announcement and, except as otherwise required by Applicable Law or such rules or regulators, the Party whose announcement has been reviewed shall remove any Confidential Information of the reviewing Party that the reviewing Party reasonably deems to be inappropriate for disclosure. The contents of any announcement or similar publicity that has been reviewed and approved by the reviewing Party can be re-released by either Party without a requirement for pre-approval.

ARTICLE 9
GENERAL PROVISIONS

9.1 Assignment . Neither Party may assign this Agreement, delegate its obligations or otherwise transfer licenses or other rights created by this Agreement, without the prior written consent of the other Party, which consent will not be unreasonably withheld; provided that each Party may assign this Agreement as a whole without such consent in connection with the acquisition (whether by merger, consolidation, sale or otherwise) of such Party, provided that such Party provides written notice to the other Party of such assignment and the assignee thereof agrees in writing to be bound as such Party hereunder. Any assignment or transfer in violation of this Section 9.1 will be void. This Agreement will inure to the benefit of, and be binding upon, the legal representatives, successors and permitted assigns of the Parties.

9.2 Force Majeure . Neither Party will be held liable or responsible to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term or condition of this Agreement if, but only to the extent that, such failure or delay results from causes beyond the reasonable control of the affected Party, potentially including fire, floods, embargoes, terrorism, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, acts of God or acts, omissions or delays in acting by any Governmental Authority or any other Party; provided that the Party affected will promptly notify the other of the force majeure condition and will exert reasonable efforts to eliminate, cure or overcome any such causes and to resume performance of its obligations as soon as possible.

9.3 Severability . If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein will not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties will in such an instance use their reasonable best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.

9.4 Amendment; Waiver . This Agreement may not be modified, amended or rescinded, in whole or part, except by a written instrument signed by the Parties; provided that

any unilateral undertaking or waiver made by one Party in favor of the other will be enforceable if undertaken in a writing signed by the Party to be charged with the undertaking or waiver. No delay or omission by either Party hereto in exercising any right or power occurring upon any noncompliance or default by the other Party with respect to any of the terms of this Agreement will impair any such right or power or be construed to be a waiver thereof. A waiver by either of the Parties of any of the covenants, conditions or agreements to be performed by the other will not be construed to be a waiver of any succeeding breach thereof or of any other covenant, condition or agreement herein contained.

9.5 Notices . Except as otherwise provided herein, all notices under this Agreement will be sent by certified mail or by overnight courier service, postage prepaid, to the following addresses of the respective Parties:

If to AMAG, to: AMAG Pharmaceuticals, Inc.

100 Hayden Ave.

Lexington, MA 02421

Attn.: Chief Executive Officer

With a required copy to: AMAG Pharmaceuticals, Inc.

100 Hayden Ave.

Lexington, MA 02421

Attn.: General Counsel

If to Access, to: Access Pharmaceuticals, Inc.

2600 Stemmons Freeway

Suite 176

Dallas TX 75207

Attn.: Chief Executive Officer

or to such address as each Party may hereafter designate by notice to the other Party. A notice will be deemed to have been given on the date it is received by all required recipients for the noticed Party.

9.6 Applicable Law, Venue . This Agreement will be governed by and construed in accordance with the laws of the New York, without reference to conflicts of laws principles. Notwithstanding the foregoing, with respect to any dispute relating to the determination of scope, validity or enforceability of any Patents, the Parties consent to the exclusive jurisdiction of the Federal courts of the United States, and the dispute shall be determined according to the laws of the United States. The Parties hereby expressly agree that the U.N. Convention on Contracts for the International Sale of Goods will not apply. Subject to Section 9.15, the Parties hereby agree to the exclusive jurisdiction of the competent courts sitting in the New York.

9.7 Further Assurances . Each Party agrees to do and perform all such further acts and things and will execute and deliver such other agreements, certificates, instruments and documents necessary or that the other Party may deem advisable in order to carry out the intent

and accomplish the purposes of this Agreement and to evidence, perfect or otherwise confirm its rights hereunder.

9.8 Relationship of the Parties . Each Party is an independent contractor under this Agreement. Nothing contained herein is intended or is to be construed so as to constitute Access and AMAG as partners, agents or joint venturers. Neither Party will have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement or undertaking with any Third Party. There are no express or implied third party beneficiaries hereunder.

9.9 Entire Agreement . This Agreement (along with the Exhibits) contains the entire understanding of the Parties with respect to the subject matter hereof and supersedes and replaces any and all previous or contemporaneous arrangements and understandings, whether oral or written, between the Parties with respect to the subject matter hereof.

9.10 Headings . The captions to the several Sections hereof are not a part of this Agreement, but are merely guides or labels to assist in locating and reading the several Sections hereof.

9.11 Waiver of Rule of Construction . Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement will be construed against the drafting party will not apply.

9.12 Interpretation . Whenever any provision of this Agreement uses the term “including” (or “includes”), such term will be deemed to mean “including without limitation” (or “includes without limitations”). “Herein,” “hereby,” “hereunder,” “hereof” and other equivalent words refer to this Agreement as an entirety and not solely to the particular portion of this Agreement in which any such word is used. All definitions set forth herein will be deemed applicable whether the words defined are used herein in the singular or the plural. Unless otherwise provided, all references to Sections and Exhibits in this Agreement are to Sections and Exhibits of this Agreement. References to any Sections include Sections and subsections that are part of the related Section ( e.g ., a section numbered “Section 3(a )” would be part of “Article 3”, and references to “Section 3” would also refer to material contained in the subsection described as “Section 3(a) “).

9.13 Counterparts; Facsimiles . This Agreement may be executed in two or more counterparts, each of which will be deemed an original and all of which together will constitute one and the same instrument. Facsimile execution and delivery of this Agreement by either Party will constitute a legal, valid and binding execution and delivery of this Agreement by such Party

9.14 Issue Resolution . Unless otherwise set forth in this Agreement or the Escrow Agreement, in the event of a dispute arising under this Agreement between the Parties (but not including a dispute relating to the Escrow Agreement which shall be governed by such Escrow Agreement), the Parties shall refer such dispute to the Chief Business Officer of AMAG (or other executive designated by the Chief Executive Officer of AMAG) and the Chief Executive Officer of Access (the “ Executive Officer(s) ”), and such Executive Officers shall attempt in good faith to resolve such dispute. If the Parties are unable to resolve a given dispute pursuant to this Section 9.14 within sixty (60) days of referring such dispute to the Executive Officers, such dispute shall be resolved by binding arbitration in the manner described in Section 9.15.

9.15 Arbitration .

(a) If a Party intends to begin an arbitration to resolve a dispute arising under this Agreement after the provisions of Section 9.14 have been exhausted (but not including a dispute relating to the Escrow Agreement which shall be governed by such Escrow Agreement) , such Party shall provide written notice (the “ Arbitration Request ”) to the other Party of such intention and the issues for resolution. From the date of the Arbitration Request and until such time as the dispute has become finally settled, the running of the time periods as to which a Party must cure a breach of this Agreement becomes suspended as to the subject matter of the dispute. Unless the Parties otherwise agree in writing, during the period of time that any arbitration proceeding is pending under this Agreement, the Parties shall continue to comply with all those terms and provisions of this Agreement that are not the subject of the pending arbitration proceeding. The arbitration proceeding shall be conducted in accordance with the Commercial Arbitration Rules and Supplementary Procedures for Large Complex Disputes of the American Arbitration Association (the “ AAA ”) and otherwise as set forth in this Section 9.15.

(b) Within ten (10) Business Days after the receipt of the Arbitration Request, the other Party may, by written notice, add additional issues for resolution; provided, that such issues have been subject to Section 9.14 and relate directly to the matter that is the subject of the applicable Arbitration Request.

(c) The arbitration shall be conducted by one arbitrator selected in accordance with the AAA Commercial Arbitration Rules and Supplementary Procedures for Large Complex Disputes as modified below, unless the matter in dispute has a value of at least [***] and either Party wishes to have the arbitration conducted by a panel of three (3) arbitrators. The arbitrator(s) shall be experienced in the subject matter of the Arbitration Request as it applies to the biotechnology or pharmaceutical business. The Parties shall cooperate to attempt to select the arbitrator(s) by agreement within twenty (20) days of the initiation of arbitration. If agreement cannot be reached within such twenty (20) days, then that AAA will submit a list of twenty (20) qualified arbitrators from which each Party shall strike unacceptable entries; provided that each Party shall not strike more than thirty-five percent (35%) of the names without cause, and rank

the remaining names. The AAA shall appoint the arbitrator(s) with the highest combined ranking(s). If these procedures fail to result in selection of the required number of arbitrators, the AAA shall appoint the arbitrator(s), allowing each side challenges for cause. The arbitrator(s) shall apply the law of New York and the arbitration shall be held in New York, New York. The Parties shall each use their best efforts to have the arbitration hearing held as soon as practicable and in any event within sixty (60) days after the selection of the arbitrator(s). At least five (5) Business Days prior to the arbitration hearing, each Party shall submit to the other Party and the arbitrator(s) a copy of all exhibits on which such Party intends to rely at the hearing, a pre-hearing brief (up to 20 pages), and a proposed ruling (up to 5 pages). The proposed ruling shall be limited to proposed rulings and remedies on each issue, and shall contain no argument on or analysis of the facts or issues. Within five (5) Business Days after close of the hearing, each Party may submit a post-hearing brief (up to 5 pages) to the arbitrator(s).

(d) Either Party may apply first to the arbitrators for interim injunctive relief until the arbitration decision is rendered or the arbitration matter is otherwise resolved; provided, that if such Party determines that such injunctive relief cannot be awarded in a timeframe adequate to protect such Party’s interests, then a Party may, without waiving any right or remedy under this Agreement, seek from any court having jurisdiction any injunctive or provisional relief necessary to protect the rights or property of that Party pending resolution of the arbitration matter pursuant to this Section 9.15. The arbitrators shall have no authority to award punitive or any other type of damages not measured by a Party’s compensatory damages. The Parties further agree that the decision of the arbitrators shall be the sole, exclusive and binding remedy between them regarding determination of arbitration matters presented.

(e) The Parties hereby agree that any disputed performance or suspended performance pending the resolution of an arbitration matter that the arbitrators determine to be required to be performed by a Party must be completed within a reasonable time period following the final decision of the arbitrators.

(f) [***].

(g) Except to the extent necessary to confirm an award or decision or as may be required by Applicable Laws, neither a Party nor an arbitrator may disclose the existence, content, or results of an arbitration without the prior written consent of both Parties.

(h) The Parties agree that, in the event of an arbitration matter involving the alleged breach of this Agreement, neither Party may terminate this Agreement until resolution of such matter pursuant to this Section 9.15, and any time period for cure will only commence after such resolution.

(i) By agreeing to this binding arbitration provision, the Parties understand that they are waiving certain rights and protections which may otherwise be available if a dispute between the Parties were determined by litigation in court, including the right to seek or obtain certain types of damages precluded by this provision, the right to a jury trial, certain rights of appeal, and a right to invoke formal rules of procedure and evidence.

(j) For avoidance of doubt, any dispute between the Parties relating to the Escrow Agreement or the [***] shall be governed by the dispute resolution provisions set forth in the Escrow Agreement.

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SIGNATURE PAGE TO LICENSE AGREEMENT

IN WITNESS WHEREOF, this Agreement has been executed by the Parties as of the Effective Date.

AMAG PHARMACEUTICALS, INC.		ACCESS PHARMACEUTICALS, INC.

By:	/s/ William K. Heiden	By:	s/ Jeffrey B. Davis

Name: William K. Heiden		Name: Jeffrey B. Davis

Title: President and Chief Executive Officer		Title: Chief Executive Officer

SCHEDULE A

Defined Terms

(b) “ AAA ” has the meaning ascribed to it in Section 9.15

(d) “ Access Know-How ” means all Technology, now existing or hereafter arising that is Controlled by Access, and that is related to the Device or that is necessary or useful for the Manufacture or Commercialization of the Device.

(e) “ Access Indemnitees ” has the meaning provided in Section 7.5(a).

(f) “ Access Intellectual Property Rights ” means, collectively, the Access Know-How, the Access Patent Rights, and the Access Trademarks.

(g) “ Access Patent Rights ” means Patents Controlled by Access during the Term that are necessary or useful for the Manufacture or Commercialization of the Device. The Access Patent Rights in existence as of the Effective Date are identified in Schedule B , attached hereto.

(h) “ Access Trademarks ” means the marks identified in Schedule C , attached hereto.

(i) “ Affiliates ” means any entity controlling, controlled by or under common control with a Party, but only as long as such control continues, where “control” means the ownership of at least fifty percent (50%) of the equity or beneficial interest of such entity, or the right to vote for or appoint a majority of the board of directors or other governing body of such entity.

(j) “ Agreement ” has the meaning provided in the introductory paragraph above.

(k) “ AMAG ” has the meaning provided in the introductory paragraph above.

(l) “ AMAG Indemnitees ” has the meaning provided in Section 7.5(b).

(m) “ Applicable Law ” means any supra-national, federal, state, provincial, commonwealth, cantonal or local government laws, treaties, statutes (including the Food, Drug and Cosmetic Act of 1938, as amended), rules and regulations, including any rules, regulations, guidance or guidelines having the binding effect of law,

or requirements of Governmental Authorities, national securities exchanges or securities listing organizations, courts, tribunals, legislative bodies and commissions that may be in effect from time to time.

(n) “ Arbitration Request ” has the meaning ascribed to it in Section 9.15

(o) “ [***] ” has the meaning provided in [***].

(p) “ Auditor ” has the meaning ascribed to it in Section 3.8.

(q) “ Bankruptcy Code ” has the meaning provided in Section 6.4.

(r) “ Business Day ” means a day other than Saturday, Sunday or any day on which commercial banks located in New York, New York are authorized or obligated by Applicable Law to close.

(s) “ Claim ” has the meaning provided in Section 7.5(c).

(t) “ Commercially Reasonable Efforts ” means, with respect to any objective related to the Manufacturing and Commercialization of the Device, efforts and resources that a company within the same industry would reasonably devote to a medical device owned by it which is of similar market potential at a similar stage in the development or life of such product, taking into account issues of safety and efficacy, device profile, the proprietary position of the device, the then current competitive environment for such medical device, the likely timing of such medical device’s entry into the market, the regulatory environment and status of such medical device, the profitability of the medical device and other relevant commercial factors.

(u) “ Commercialization ” or “ Commercialize ” means activities directed to the marketing, promoting, distributing, importing, exporting, offering for sale or selling a Device.

(v) “ Commercialization Plan ” has the meaning ascribed to it in Section 2.5.

(w) “ Competitive Device ” has the meaning provided in Section 2.3.

(x) “ Confidential Information ” means all confidential or proprietary information including information comprising or relating to the activities conducted pursuant to this Agreement, that is disclosed or provided by a Party or its Affiliates to the other Party or its Affiliates, regardless of whether any of the foregoing are marked “confidential” or “proprietary” or communicated to the other by the disclosing Party or its Affiliates in oral, written, graphic, or electronic form.

(y) “ [***] ” has the meaning ascribed to it in [***].

(z) “ Control ” means, with respect to any material, information or intellectual property right, that a Party owns or has a license or other legal right and ability to grant to the other Party an option, access, a license or a sublicense (as applicable) on the terms and conditions set forth herein without violating the terms of any agreement or other arrangement with any Third Party applicable to such material, information or intellectual property right and existing at the time such option, access, license or sublicense, as applicable, is granted.

(aa) “ Convicted Individual ” or “ Convicted Entity ” means an individual or entity, as applicable, who has been convicted of a criminal offense that falls within the ambit of 21 U.S.C. §335a (a) or 42 U.S.C. §1320a — 7(a), but has not yet been excluded, debarred, suspended or otherwise declared ineligible.

(bb) “ Customer ” means Third Parties (e.g., wholesalers, specialty pharmacies, etc.) to whom Access or its Affiliates or Sublicensees have sold Devices.

(cc) “ Debarred Individual ” means an individual who has been debarred by the U. S. Food and Drug Administration (“ FDA ”) pursuant to 21 U.S.C. §335a (a) or (b) from providing services in any capacity to a person that has an approved or pending drug product application.

(dd) “ Debarred Entity ” means a corporation, partnership or association that has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from submitting or assisting in the submission of any abbreviated drug application, or a subsidiary or affiliate of a Debarred Entity.

(ee) “ Device ” means the MuGard TM device, a viscous, mucoadhesive rinse that is based on Access Intellectual Property Rights, in any dosage form, formulation and form of administration for use in the Field.

(ff) “ Device Returns ” means any Devices that have been sold or otherwise used and that have been sent back to AMAG for any reason.

(gg) “ Disclosing Party ” has the meaning provided in Section 8.1(a).

(hh) “ Diverted Product ” has the meaning provided in Section 2.4.

(ii) “ Effective Date ” has the meaning provided in the introductory paragraph above.

(jj) “ Escrow Agent ” has the meaning provided in Section 4.1(d).

(kk) “ Escrow Agreement ” has the meaning provided in Section 4.1(d).

(ll) “ Excess Load In Charge ” has the meaning ascribed to it in Section 5.1(a) .

(mm) “ Excluded Individual ” or “ Excluded Entity ” means (i) an individual or entity, as applicable, who has been excluded, debarred, suspended or is otherwise ineligible to participate in federal health care programs such as Medicare or Medicaid by the Office of the Inspector General (OIG/HHS) of the U.S. Department of Health and Human Services, or (ii) an individual or entity, as applicable, who has been excluded, debarred, suspended or is otherwise ineligible to participate in federal procurement and non-procurement programs, including those produced by the U.S. General Services Administration.

(nn) “ Executive Officers ” has the meaning ascribed to it in Section 9.14 .

(oo) “ FDA ” means the United States Food and Drug Administration of the Department of Health and Human Services, or any successor agency(ies).

(pp) “ [***] ” has the meaning ascribed to it in [***].

(qq) “ [***] ” has the meaning ascribed to it in [***].

(rr) “ Field ” has the meaning ascribed to it in Section 2.1.

(ss) “ First Commercial Sale ” means, with respect to the Device, the first transfer by AMAG or any of its Affiliates or Sublicensees for value in an arms’-length transaction to an independent Third Party distributor, agent or end user in the Territory after obtaining [***] necessary for such transfer and to commence regular commercial sales in the United States.

(tt) “ [***] ” has the meaning ascribed to it in [***].

(uu) “ Governmental Authority ” means any and all governmental and regulatory authorities having jurisdiction over the Device in the Territory, or over any performance or obligations associated with this Agreement, including but not limited to the FDA or any other successor entities thereto.

(vv) “ Governmental Clearances ” means any and all permits, licenses, authorizations, and clearances, including Regulatory Clearances required by any Governmental Authority for the manufacture, importation, marketing and selling of the Device in the Territory.

(ww) “ Healthcare Law ” means the laws, codes, policies and guidelines of all Governmental Authorities relating to the production, preparation, propagation, compounding, conversion, pricing, marketing, promotion, sale, distribution, coverage, or reimbursement of a drug, device, biological or other medical item, supply or service, including, without limitation, the federal Food, Drug and Cosmetic Act (21 U.S.C. § 321 et seq.), the federal False Claims Act (31 U.S.C. §§ 3729 et seq.), the federal healthcare program anti-kickback statute (42 U.S.C. § 1320a-7b), the healthcare fraud, false statement and health information privacy and security provisions of the Health Insurance

Portability and Accountability Act of 1996 (“ HIPAA ”), as amended by the Health Information Technology for Economic and Clinical Health (“ HITECH ”) Act, the Foreign Corrupt Practices Act, the U.K. Anti-Bribery Act, the federal healthcare program civil money penalty and exclusion authorities, the applicable requirements of Medicare, Medicaid and other Governmental Body healthcare programs, including the Veterans Health Administration and U.S. Department of Defense healthcare and contracting programs, and the analogous Laws of any state or country applicable to the Agreement.

(xx) “ Indemnitee ” has the meaning provided in Section 7.5(c).

(yy) “ Indemnitor ” has the meaning provided in Section 7.5(c).

(zz) “ [***] ” has the meaning ascribed to it in [***].

(aaa) “ Inventory ” has the meaning provided in Section 5.1(c).

(bbb) “ Losses ” has the meaning provided in Section 7.5(a).

(ccc) “ Manufacturing ” means any and all activities related to the production of a Device Commercialized under this Agreement. Manufacturing shall include: (i) technical and process development activities in connection with development of the manufacturing or production process for the Device; (b) manufacturing and production activities; (iii) quality assurance activities; (d) testing activities, including stability testing and conformance testing; and (v) any and all other activities required to release manufacturing lots of Devices. When used as a verb, Manufacture means to engage in Manufacturing.

(ddd) “ [***] Transition Period ” has the meaning ascribed to it in Section 5.1(b).

(eee) “ MDRs ” has the meaning ascribed to it in Section 7.1(f).

(fff) “ Net Sales ” means the gross amount invoiced for sales of the Device by AMAG, its Affiliates and any Sublicensees to a Third Party distributor or agent (in each case, who is not a Sublicensee), or end user less the following amounts, to the extent actually incurred or accrued, related to the Device:

[***] .

(ggg) “ Parties ” has the meaning provided in the introductory paragraph above.

(hhh) “ Party ” has the meaning provided in the introductory paragraph above.

(iii) “ Patent ” means patents and patent applications Controlled by Access or its Affiliates and licensed to AMAG hereunder, in the Territory, including any divisionals, continuations, continuations-in-part, substitutions, reissues, re-examinations, revalidations, patent term extensions, and renewals of any such patents or patent applications, that claim or cover the Device or Commercialization thereof.

(jjj) “ Person ” means any individual, firm, corporation, partnership, limited liability company, trust, joint venture, Governmental Authority, or other entity or organization.

(kkk) “ Promotional Materials ” has the meaning provided in Section 6.3(b).

(lll) “ Quality Agreement ” has the meaning provided in Section 5.1(f).

(mmm) “ Quality and Supply Agreements ” has the meaning provided in Section 5.1(f).

(nnn) “ QSR ” has the meaning provided in Section 4.3(a).

(ooo) “ Receiving Party ” has the meaning provided in Section 8.1(a).

(ppp) “ Regulatory Clearance ” means the 510(k) clearance for the Device, and any other clearance or approval that is necessary to allow the Device to be marketed and sold in the Territory.

(qqq) “ Release Event ” has the meaning ascribed to it in Section 4.9(c).

(rrr) “ Retained Sales ” has the meaning provided in Section 5.1(a).

(sss) “ Retained Liabilities ” has the meaning provided in Section 5.1(a).

(ttt) “ Royalty Term ” has the meaning provided in Section 3.3.

(uuu) “ Second Source” has the meaning provided in Schedule E.

(vvv) “ [***] ” has the meaning provided in [***] .

(www) “ Specifications ” has the meaning provided in Schedule E .

(xxx) “ Specified Event ” has the meaning provided in Section 4.9.

(yyy) “ Sublicensee ” means any Person to whom AMAG grants a sublicense of the rights and licenses granted to AMAG by Access under Section 2.1, excluding Persons that are granted such a sublicense solely to perform services for the benefit of AMAG or an Affiliate of AMAG and are not granted any rights to make use or sell Devices to any other Person, including contract manufacturers.

(zzz) “ Supply Agreement ” has the meaning provided in Section 5.1(f).

(aaaa) “ Technology ” means know-how, trade secrets, chemical and biological materials, formulations, information, documents, studies, results, data and regulatory approvals, data, filings and correspondence, including biological, chemical, pharmacological, toxicological, pre-clinical, clinical and assay data, manufacturing processes and data, specifications, sourcing information, assays, and quality control and testing procedures, whether or not patented or patentable.

(bbbb) “ Term ” has the meaning provided in Section 6.1.

(cccc) “ Territory ” means the fifty states of the United States of America, its territories and possessions, including the Commonwealth of Puerto Rico, and the District of Columbia.

(dddd) “ Third Party ” means any Person other than AMAG, Access and their Affiliates.

(eeee) “ Third Party Agreements ” has the meaning provided in Section 7.1(h).

(ffff) “ Valid Claim ” means any claim of an issued and unexpired Patent that (a) has not been held permanently revoked, unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction, which decision is unappealable or unappealed within the time allowed for appeal and (b) has not been abandoned, disclaimed, surrendered or declared invalid or unenforceable in a final, unappealable or unappealed decision of a judicial or administrative court, government agency or patent office of appropriate jurisdiction.

(gggg) “ [***] ” has the meaning ascribed to it in Section 4.9(c).

[ Remainder of this page is intentionally left blank ]

SCHEDULE B

Access Patent Rights

U.S. Patent #7,547,433

U.S. Patent #7,544,348

SCHEDULE C

Access Trademarks

Word Mark		MUGARD

Goods and Services		IC 005. US 006 018 044 046 051 052. G & S: Pharmaceutical preparations for the prevention and treatment of disorders of the nervous system, the immune system, the cardio-vascular system, the metabolic system, the respiratory system, the musculo-skeletal system, the genitourinary system; for the treatment of inflammatory disorders; for use in dermatology, oncology, hematology and in tissue and organ transplantation, in ophthalmology and for gastroenterological disorders; Pharmaceutical preparations for the prevention and treatment of ocular disorders or diseases, for the treatment of bacteria-based diseases, and for the treatment of diabetes, and anti-infective preparations, antiviral preparations, antibiotics, antifungal preparations and vaccines; Pharmaceutical preparations for the treatment and prevention of oral and esophageal mucositis; drug delivery agents consisting of compounds that facilitate delivery of a wide range of active pharmaceuticals to the oral mucosa. FIRST USE: 20061225. FIRST USE IN COMMERCE: 20061225

Standard Characters Claimed

Mark Drawing Code		(4) STANDARD CHARACTER MARK

Serial Number		85116721

Filing Date		August 26, 2010

Current Basis		1A

Original Filing Basis		1A

Published for Opposition		February 8, 2011

Registration Number		3950832

Registration Date		April 26, 2011

Owner		(REGISTRANT) Access Pharmaceuticals CORPORATION DELAWARE 2600 Stemmons Parkway, Suite 176 Dallas TEXAS 75207

Type of Mark		TRADEMARK

Register		PRINCIPAL

Live/Dead Indicator		LIVE

SCHEDULE D

Third Party Agreements

A. To be Assigned to AMAG

[***]

B. To be Assigned Upon Amendment signed by Counter-Party

[***]

C. To be Maintained by Access

[***]

D. To be Terminated by Access

[***]

SCHEDULE E

QUALITY AND SUPPLY AGREEMENTS TERMS

This Schedule E describes the basic scope and principles to be included in the Quality and Supply Agreements, which will govern supply of AMAG requirements of the Device pursuant to the terms of Article 5.1(f) of the License Agreement. Capitalized terms used but not defined in this Schedule E shall have the meanings provided in the Agreement.

Scope

1) This Schedule E is not intended to include all terms and conditions anticipated to be included in the Quality and Supply Agreements. The Quality and Supply Agreement will describe and define the procedures, terms and conditions for forecasting, manufacture, analytical testing, quality assurance, delivery, price, payment and appropriate other activities relating to the supply of the Device in the Field and in the 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

2) AMAG shall purchase from and Access shall supply to AMAG the Device in finished form for use under the Agreement and in accordance with the terms of the Supply Agreement and the Quality Agreement.

3) The term of the Supply Agreement and the Quality Agreement shall be coextensive with the Term of the Agreement.

4) Access shall use Commercially Reasonable Efforts to manage AMAG’s supply needs (e.g., volumes and unit costs) for the Territory in a manner proportionate to Access’ supply needs outside the Territory.

Price/ Payment

5) The purchase price for supply of Device shall be the cost thereof actually paid by Access to its Third Party supplier(s) plus [***] . Access shall use Commercially Reasonable Efforts to manage purchase price for supply of Device in accordance with its existing agreement with the contract manufacturing organization.

6) Payment terms are net [***] from receipt of invoice to be issued after shipment.

7) Access shall obtain AMAG’s prior written consent regarding any capital equipment proposed to be acquired for use in supplying Device to AMAG and for which AMAG would bear all or some portion of the costs. If any such equipment

is attributable to both the Territory and outside the Territory, the Parties will use good faith efforts to agree on a reasonable allocation of such expenditures to the Territory and outside the Territory, based on the volumes supplied for each such territory. The Supply and Quality Agreements 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

8) The Supply Agreement will contain mutually agreed information sharing and planning procedures with respect to the forecasting and supply of the Device.

Delivery

9) Delivery requirements, location and applicable Incoterms shall be defined in the Supply Agreement.

Quality Agreement and Manufacture and Quality Control

10) The parties will enter into a quality agreement within one month after the Effective Date in accordance with the Agreement.

11) Device shall be manufactured in compliance with cGMP, as defined by regulatory authorities within the Territory. The Device shall be manufactured according to specifications for the Device set forth in the Quality Agreement (“ Specifications ”).

12) The Quality Agreement will contain change control procedures for the Specifications and other related matters.

13) The Quality Agreement shall define a procedure for resolution of any disputes regarding product quality.

14) In accordance with Section 4.5 of the Agreement, 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 Device is manufactured, packaged, labeled and/or tested, and shall allow reasonable access to related documentation. The purpose of such audit shall be to assess compliance with the cGMP and applicable Laws in the country of manufacture in accordance with Section 4.5 of the Agreement.

Second Source / Safety Stock

15) The Supply Agreement will contain procedures for implementing a second source of supply (a “ Second Source ”).

16) AMAG shall [***] associated with qualifying, initiating and maintaining the second source of supply (the “ [***] ”). If Access desires to make use of the Second Source for supply needs outside the Territory, the Parties shall use good faith efforts to agree on a [***] , based on the volumes supplied for each such territory.

Product Warranty

17) Access will provide standard warranties including warranties that all Devices:

i) shall be manufactured and tested (while in the possession or control of Access, including its third party contract manufacturer) in accordance with all applicable laws, rules, regulations or guidelines of any relevant Regulatory Authority in the United States or any jurisdiction where Access is having Devices manufactured for AMAG, and GMPs applicable to the manufacture, storage, and shipment of Devices,

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 in the United States or any jurisdiction where Access is having Devices manufactured for AMAG,

iii) conforms to the Specifications, and

iv) will have a shelf life of no less than [***] from the date of shipment.

This warranty does not apply to any non-conformity of the Device resulting from (i) alteration, misuse, negligence, abuse, accident, mishandling or storage in an improper environment in each case by any party other than Access or its agents or (ii) use, handling, storage or maintenance other than in accordance with the Specifications. THE FOREGOING WARRANTY IS THE SOLE AND EXCLUSIVE WARRANTY GIVEN BY ACCESS WITH RESPECT TO THE DEVICE, AND ACCESS GIVES AND MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT.

SCHEDULE F

Form of [***] Letter

(attached)

[***]

SCHEDULE G

Form of [***] Letter

[***]

SCHEDULE H

Form of Escrow Agreement

(attached)

Three-Party Escrow Service Agreement

1. Introduction

This Three-Party Escrow Service Agreement (the “ Agreement ”) is entered into by and between Access Pharmaceuticals, Inc. (the “ Depositor ”), AMAG Pharmaceuticals, Inc. (the “ Beneficiary ”) and (“ Escrow Agent ”). Depositor, Beneficiary, and Escrow Agent may be referred to individually as a “Party” or collectively as the “Parties” throughout this Agreement.

(a) The use of the term services in this Agreement shall refer to Escrow Agent services that facilitate the creation, management, and enforcement of escrow accounts as described in Exhibit A attached hereto (“ Services ”). A Party shall request Services under this Agreement by submitting a work request for certain Escrow Agent Services (“ Work Request ”) via written instruction or the online portal maintained at the website located at .com or other websites owned or controlled by Escrow Agent that are linked to that website (collectively the “ Escrow Agent Website ”).

(b) The Beneficiary and Depositor have entered into a License Agreement dated June , 2013 (the “License Agreement” ). The License Agreement conveys certain licenses and rights to the Beneficiary, and the Parties intend this Agreement to be considered as supplementary to the License Agreement, pursuant to Title 11 United States Code, Section 365(n).

2. Depositor Responsibilities and Representations

(a) Depositor shall make a deposit of [***] (“ Deposit Material ”) to Escrow Agent within [***] of the Effective Date.

(b) Depositor represents that it lawfully possesses all Deposit Material provided to Escrow Agent under this Agreement and that any current or future liens or encumbrances will not prohibit, limit, or alter the rights and obligations of Escrow Agent under this Agreement. Depositor warrants that with respect to the Deposit Material, Escrow Agent’s proper administration of this Agreement will not violate the rights of any third parties.

3. Beneficiary Acknowledgement

(a) Beneficiary acknowledges that, as between Escrow Agent and Beneficiary, Escrow Agent’s obligation is to maintain the Deposit Material as delivered by the Depositor.

4. Escrow Agent Responsibilities and Representations

(a) Escrow Agent will follow the provisions of Exhibit C attached hereto in administering the release of Deposit Material.

(b) Escrow Agent will hold and protect Deposit Material in physical vaults that are either owned or under the control of Escrow Agent, unless otherwise agreed to by all the Parties.

(c) Should transport of Deposit Material be necessary in order for Escrow Agent to perform services requested by Depositor or Beneficiary under this Agreement, Escrow Agent will use a commercially recognized overnight carrier such as Federal Express or United Parcel Service. Escrow Agent will not be responsible for any loss or destruction of, or damage to, such Deposit Material while in the custody of the common carrier.

5. Payment

Beneficiary shall pay to Escrow Agent all Service Fees as set forth herein. [Description of fees to be inserted here (the “Service Fees” ).] All Service Fees are due within thirty (30) calendar days from the date of invoice in U.S. currency and are non-refundable.

6. Term and Termination

(a) The term of this Agreement is for a period of one (1) year from the Effective Date (“ Initial Term ”) and will automatically renew for additional one (1) year terms (“ Renewal Term ”) (collectively the “ Term ”). This Agreement shall continue in full force and effect until one of the following events occurs : (i) Depositor and Beneficiary provide Escrow Agent with sixty (60) days’ prior written notice pursuant to a document that is executed by both Beneficiary and Depositor indicating their intent to terminate this Agreement; (ii) Beneficiary provides Escrow Agent and Depositor with sixty (60) days’ prior written notice of Beneficiary’s intent to terminate this Agreement; or (iii) the Agreement terminates under another provision of this Agreement.

7. Warranties

(a) ESCROW AGENT WARRANTS ANY AND ALL SERVICES PROVIDED HEREUNDER SHALL BE PERFORMED IN A WORKMANLIKE MANNER AND IN A MANNER CONSISTENT WITH THE MEASURES ESCROW AGENT TAKES TO PROTECT ITS OWN INFORMATION OF A SIMILAR NATURE, BUT IN NO CASE LESS THAN A REASONABLE LEVEL OF CARE. EXCEPT AS SPECIFIED IN THIS SECTION, ALL CONDITIONS, REPRESENTATIONS, AND WARRANTIES INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OR CONDITIONS OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, SATISFACTORY QUALITY, OR ARISING FROM A COURSE OF DEALING, USAGE, OR TRADE PRACTICE, ARE HEREBY EXCLUDED TO THE EXTENT ALLOWED BY APPLICABLE LAW. AN AGGRIEVED PARTY MUST NOTIFY ESCROW AGENT PROMPTLY UPON LEARNING OF ANY CLAIMED BREACH OF ANY WARRANTY AND, TO THE EXTENT ALLOWED BY APPLICABLE LAW, SUCH PARTY’S REMEDY FOR BREACH OF THIS WARRANTY SHALL BE SUBJECT TO THE LIMITATION OF LIABILITY AND CONSEQUENTIAL DAMAGES WAIVER IN THIS AGREEMENT. THIS DISCLAIMER AND EXCLUSION SHALL APPLY EVEN IF THE EXPRESS WARRANTY AND LIMITED REMEDY SET FORTH ABOVE FAILS OF ITS ESSENTIAL PURPOSE.

(b) Depositor warrants that all Depositor information provided hereunder is accurate and reliable.

8. Confidential Information

Escrow Agent shall have the obligation to implement and maintain safeguards designed to protect the confidentiality of the Deposit Material. Except as provided in this Agreement Escrow Agent shall not use, disclose, transfer or otherwise make available the Deposit Material. Escrow Agent shall not disclose the terms of this Agreement to any third party other than its financial, technical, or legal advisors, or its administrative support service providers. Any such third party shall be bound by the same confidentiality obligations as Escrow Agent. If Escrow Agent receives a subpoena or any other order from a court or other judicial tribunal pertaining to the disclosure or release of the Deposit Material, Escrow Agent

will promptly notify the Parties to this Agreement unless prohibited by law. After notifying the Parties, Escrow Agent may comply in good faith with such order. It shall be the responsibility of Depositor or Beneficiary to challenge any such order; provided, however, that Escrow Agent does not waive its rights to present its position with respect to any such order. Escrow Agent will cooperate with the Depositor or Beneficiary, as applicable, to support efforts to quash or limit any subpoena, at such Party’s expense. Any Party requesting additional assistance shall pay Escrow Agent’s standard charges or as quoted upon submission of a detailed request.

9. Limitation of Liability

EXCEPT FOR: (I) LIABILITY FOR DEATH OR BODILY INJURY; (II) PROVEN GROSS NEGLIGENCE OR WILLFUL MISCONDUCT; OR (III) BREACH BY ESCROW AGENT OF THE CONFIDENTIALITY OBLIGATIONS SET FORTH IN SECTION 8, ALL OTHER LIABILITY RELATED TO THIS AGREEMENT, IF ANY, WHETHER ARISING IN CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, OF ANY PARTY TO THIS AGREEMENT SHALL BE LIMITED TO THE AMOUNT EQUAL TO ONE YEAR OF FEES PAID TO ESCROW AGENT UNDER THIS AGREEMENT. IF CLAIM OR LOSS IS MADE IN RELATION TO A SPECIFIC DEPOSIT OR DEPOSITS, SUCH LIABILITY SHALL BE LIMITED TO THE FEES RELATED SPECIFICALLY TO SUCH DEPOSITS.

10. Consequential Damages Waiver

EXCEPT FOR (I) A GROSSLY NEGLIGENT BREACH BY ESCROW AGENT OF THE CONFIDENTIALITY OBLIGATIONS SET FORTH IN SECTION 8 OR (II) ANY ACTS OF WILLFUL MISCONDUCT, IN NO EVENT SHALL ANY PARTY TO THIS AGREEMENT BE LIABLE TO ANOTHER PARTY FOR ANY INCIDENTAL, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES, LOST PROFITS, ANY COSTS OR EXPENSES FOR THE PROCUREMENT OF SUBSTITUTE SERVICES (EXCLUDING SUBSTITUTE ESCROW SERVICES), OR ANY OTHER INDIRECT DAMAGES, WHETHER ARISING IN CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE EVEN IF THE POSSIBILITY THEREOF MAY BE KNOWN IN ADVANCE TO ONE OR MORE PARTIES.

11. General

(a) Choice of Law . The validity, interpretation, and performance of this Agreement shall be controlled by and construed under the laws of New York, as if performed wholly within the state and without giving effect to the principles of conflicts of laws.

(b) Authorized Person(s ). Depositor and Beneficiary must each authorize and designate one person whose actions will legally bind such Party (“Authorized Person” who shall be identified in the Authorized Person(s) Notices Table of this Agreement or such Party’s legal representative) and who may manage the Escrow Agent escrow account through the Escrow Agent website or written instruction. The Authorized Person for each the Depositor and Beneficiary will maintain the accuracy of their name and contact information provided to Escrow Agent during the Term of this Agreement.

(c) Right to Rely on Instructions . With respect to release of Deposit Material or the destruction of Deposit Material, Escrow Agent shall rely on instructions from a Party’s Authorized Person(s); provided, that in the case of a release of the Deposit Material, such instructions are in accordance with the requirements in Exhibit C. In all other cases,

Escrow Agent may act in reliance upon any instruction, instrument, or signature reasonably believed by Escrow Agent to be genuine and from an Authorized Person(s), officer, or other employee of a Party. Escrow Agent may assume that such representative of a Party to this Agreement who gives any written notice, request, or instruction has the authority to do so. Escrow Agent will not be required to inquire into the truth of, or evaluate the merit of, any statement or representation contained in any notice or document reasonably believed to be from such representative.

(d) Force Majeure . No Party shall be liable for any delay or failure in performance due to events outside the defaulting Party’s reasonable control, including without limitation acts of God, earthquake, labor disputes, shortages of supplies, riots, war, acts of terrorism, fire, epidemics, or delays of common carriers or other circumstances beyond its reasonable control. The obligations and rights of the excused Party shall be extended on a day-to-day basis for the time period equal to the period of the excusable delay.

(e) Notices . All notices regarding Exhibit A (Release of Deposit Material) shall be sent by commercial express mail or other commercially appropriate means that provide prompt delivery and require proof of delivery. All other correspondence, including invoices, payments, and other documents and communications, may be sent electronically or via regular mail. The Parties shall have the right to rely on the last known address of the other Parties. Any correctly addressed notice to the last known address of the other Parties that is relied on herein, that is refused, unclaimed, or undeliverable shall be deemed effective as of the first date that said notice was refused, unclaimed, or deemed undeliverable by electronic mail, the postal authorities, or through messenger or commercial express delivery service.

(f) No Waiver . No waiver of any right under this Agreement by any Party shall constitute a subsequent waiver of that or any other right under this Agreement.

(g) Assignment . No assignment of this Agreement by Depositor or Beneficiary or any rights or obligations of Depositor or Beneficiary under this Agreement is permitted without the written consent of Escrow Agent, which shall not be unreasonably withheld or delayed; provided that (1) Depositor may assign this Agreement without the consent of Beneficiary or Escrow Agent in connection with a permitted assignment of all of the License Agreement, to the same person or entity successor; and (2) Beneficiary may assign this Agreement without the consent of Depositor or Escrow Agent in connection with a permitted assignment of all of the License Agreement, to the same person or entity successor. Escrow Agent shall have no obligation in performing this Agreement to recognize any successor or assign of Depositor or Beneficiary unless Escrow Agent receives clear, authoritative and conclusive written evidence of the change of Parties.

(h) Severability . In the event any of the terms of this Agreement become or are declared to be illegal or otherwise unenforceable by any court of competent jurisdiction, such term(s) shall be null and void and shall be deemed deleted from this Agreement. All remaining terms of this Agreement shall remain in full force and effect. If this paragraph becomes applicable and, as a result, the value of this Agreement is materially impaired for any Party, as determined by such Party in its sole discretion, then the affected Party may terminate this Agreement by written notice to the other Parties.

(i) Independent Contractor Relationship . Depositor and Beneficiary understand, acknowledge, and agree that Escrow Agent’s relationship with Depositor and Beneficiary

will be that of an independent contractor and that nothing in this Agreement is intended to or should be construed to create a partnership, joint venture, or employment relationship.

(j) Attorneys’ Fees . Any costs and fees incurred by Escrow Agent in the performance of obligations imposed upon Escrow Agent solely by virtue of its role as escrow service provider including, without limitation, compliance with subpoenas, court orders, and discovery requests shall, unless adjudged otherwise, be divided equally and paid by Depositor and Beneficiary. In any suit or proceeding between the Parties relating to this Agreement, the prevailing Party will have the right to recover from the other(s) its costs and reasonable fees and expenses of attorneys, accountants, and other professionals incurred in connection with the suit or proceeding, including costs, fees and expenses upon appeal, separately from and in addition to any other amount included in such judgment. This provision is intended to be severable from the other provisions of this Agreement, and shall survive and not be merged into any such judgment.

(k) No Agency . No Party has the right or authority to, and shall not, assume or create any obligation of any nature whatsoever on behalf of the other Parties or bind the other Parties in any respect whatsoever.

(l) Disputes . Any dispute, difference or question relating to or arising among (a) Escrow Agent and (b) either or both of Depositor or Beneficiary concerning the construction, meaning, effect or implementation of this Agreement or the rights or obligations of any Party hereof will be submitted to, and settled by arbitration by a single arbitrator chosen by the corresponding Regional Office of the American Arbitration Association in accordance with the Commercial Rules of the American Arbitration Association. The Depositor and Beneficiary shall both us commercially reasonable efforts to conclude the dispute resolution process within 15 business days. The Parties shall submit briefs of no more than 10 pages and the arbitration hearing shall be limited to two (2) days maximum. The arbitrator shall apply New York law. Unless otherwise agreed by the Parties, arbitration will take place in New York, New York , U.S.A. Any court having jurisdiction over the matter may enter judgment on the award of the arbitrator. Service of a petition to confirm the arbitration award may be made by regular mail or by commercial express mail, to the attorney for the Party or, if unrepresented, to the Party at the last known business address. If however, Depositor or Beneficiary refuse to submit to arbitration, the matter shall not be submitted to arbitration and Escrow Agent may submit the matter to any court of competent jurisdiction for an interpleader or similar action.

(m) No Third Party Rights . This Agreement is made solely for the benefit of the Parties to this Agreement and their respective permitted successors and assigns, and no other person or entity shall have or acquire any right by virtue of this Agreement unless otherwise agreed to by all the Parties hereto.

(n) Counterparts . This Agreement may be executed in any number of counterparts, each of which shall be an original, but all of which together shall constitute one instrument.

(balance of this page left intentionally blank — signature page follows)

SIGNATURE PAGE to

Three-Party Escrow Service Agreement

IN WITNESS WHEREOF, the Parties have duly executed this Agreement as of the Signing Date by their authorized representatives:

DEPOSITOR: ACCESS PHARMACEUTICALS, INC.				BENEFICIARY: AMAG PHARMACEUTICALS, INC.

Signature				Signature
Print Name				Print Name
Title				Title
Date				Date
Email Address				Email Address

ESCROW AGENT

Signature
Print Name
Title
Date
Email Address

Authorized Person(s) Notices Table

Please provide the name(s) and contact information of the Authorized Person(s) under this Agreement. Please complete all information as applicable. Incomplete information may result in a delay of processing.

DEPOSITOR (Required information)				BENEFICIARY (Required information)

Print Name				Print Name
Title				Title
Email Address				Email Address
Street Address				Street Address
Province/City/State				Province/City/State
Postal/Zip Code				Postal/Zip Code
Phone Number				Phone Number
Fax Number				Fax Number

Billing Contact Information Table

Please provide the name and contact information of the Billing Contact under this Agreement. All Invoices will be sent to this individual at the address set forth below.

Email Address				Email Address
Street Address				Street Address
Province/City/State				Province/City/State
Postal/Zip Code				Postal/Zip Code
Phone Number				Phone Number
Fax Number				Fax Number
Purchase Order #				Purchase Order #

Exhibit A

Release of Deposit Material

Deposit Account
Number

Escrow Agent will use the following procedures to process any Beneficiary request to release Deposit Material.

1. Release Conditions .

Depositor and Beneficiary agree that a request for the release of the Deposit Material may only be issued by Beneficiary if such request satisfies the following condition (defined as the “ Release Condition ”):

In the form attached as Annex A-1 , Beneficiary represents and warrants that a Release Event (as defined in the License Agreement) has occurred and Depositor has failed to [***] .

2. Beneficiary’s Demand Release Work Request for Release of Deposit Material .

Beneficiary may submit a request for release of the Deposit Material if Beneficiary believes in good faith that the Release Condition has occurred (a “ Demand Release Work Request ”). The Beneficiary’s Demand Release Work Request will be in the form attached as Annex A-1 .

3. Demand Release of Deposit Material .

A. [***]

Upon receipt of such Demand Release Work Request for (i) [***] (ii) [***] and (iii) [***] , Escrow Agent Escrow Agent shall provide a copy of the notice to Access, by certified mail, return receipt requested, or by commercial express mail. From the date Escrow Agent mails the notice requesting release of the Deposit Material, Depositor shall have five (5) business days to deliver to Escrow Agent Contrary Instructions. For purposes of this Agreement, “ Contrary Instructions ” shall mean the written representation by Depositor that a Release Condition has not occurred or has been cured. Upon receipt of Contrary Instructions, Escrow Agent shall send a copy to Beneficiary by certified mail, return receipt requested, or by commercial express mail. Additionally, Escrow Agent shall notify both Depositor and Beneficiary that there is a dispute to be resolved pursuant to the Dispute Resolution section of this Agreement. Escrow Agent will continue to store the Deposit Material without release pending (a) joint instructions from Depositor and Beneficiary, (b) resolution pursuant to the Dispute Resolution provisions, or (c) order of a court. If Escrow Agent does not receive Contrary Instructions from the Depositor, Escrow Agent is authorized to release the Deposit Material to the Beneficiary. Escrow Agent is entitled to receive any undisputed, unpaid Service Fees due Escrow Agent from the Parties before fulfilling the Demand Release Work Request for release of the Deposit Material covered under this Agreement. Any Party may cure a default of payment of Service Fees.

B. Demand Release for [***]

Upon receipt of such Demand Release Work Request for a [***] , Escrow Agent shall provide a copy of the notice to Access, by certified mail, return receipt requested, or by commercial express mail. In the case of a [***] , Depositor shall not have any right or ability to deliver to Escrow Agent Contrary Instructions. Accordingly, Escrow Agent is authorized to release the Deposit Material to the Beneficiary upon receipt of such Demand Release Work Request for a [***] . Escrow Agent is entitled to receive any undisputed, unpaid Service Fees due Escrow Agent from the Parties before fulfilling the Demand Release Work Request for release of the Deposit Material covered under this Agreement. Any Party may cure a default of payment of Service Fees.

4. Termination of Agreement Upon Release .

This Agreement will terminate upon the release of Deposit Material held by Escrow Agent.

5. Rights Following Release .

Following release of the Deposit Material, Depositor and Beneficiary shall be entitled to exercise their respective rights and obligations under the License Agreement as provided therein.

Annex 1 to Exhibit A (Release of Deposit Material)

Beneficiary Certificate

Deposit Account Number

[ Date ]

Escrow Agent

[Address]

Re: AMAG Beneficiary Certificate — Deposit Account Number [ ]

Dear [ ]:

Reference is hereby made to the Three Party Escrow Services Agreement (the “ Escrow Agreement ”), dated June [ ], 2013, by and among Access Pharmaceuticals, Inc. (“ Depositor ”), AMAG Pharmaceuticals, Inc. (“ Beneficiary ”) and [Escrow Agent] (the “ Escrow Agent ”). Except as otherwise provided below, capitalized terms used herein but not otherwise defined herein shall have the meanings assigned to them in the Escrow Agreement.

Beneficiary hereby represents and warrants that that a Release Event (as defined in the License Agreement) has occurred and Depositor has failed to deliver to Beneficiary [***] .

As such, Beneficiary hereby represents that the Release Condition has been satisfied. Accordingly, Beneficiary hereby instructs the Escrow Agent to release the Deposit Material to Beneficiary as soon as practicable in accordance with Exhibit A of the Escrow Agreement.

		Sincerely,

AMAG PHARMACEUTICALS, INC.


By:
	(Signature)

Name:

Title:

Exhibit 10.2

Date: 28 May 2013

QUALITY AGREEMENT

Quality Agreement for the Product/Service:

This document constitutes the Quality Agreement (“Agreement”) between Packaging Coordinators, Inc. (“PCI”) and AMAG Pharmaceuticals, Inc. (“AMAG”) for product storage and commercial packaging and labeling services, more specifically with regard to 20mL 1ct and 10ct (WIP, FG) Feraheme (“Services”).

This Agreement defines the individual responsibilities of PCI and AMAG. Specifically, this Agreement defines which party is responsible for the cGMP aspects of packaging, storage and release, as applicable. Furthermore, this Agreement specifies the way in which the batches will be released to ensure compliance with the approved product specifications.

This Agreement is composed of a detailed checklist of the activities associated with contract packaging, storage, release, distribution and certain other regulatory requirements. This Agreement shall be incorporated within and constitute a part of the Commercial Packaging Services Agreement, dated May 29, 2009, as such agreements may be amended from to time to time (“Service Agreement”). Responsibility for each activity is assigned to either or PCI to AMAG in the appropriate tick box.

In the event of a conflict between this Agreement and the Service Agreement, then such Service Agreement shall control, except with respect to quality assurance requirements which shall be controlled by this Agreement. This Quality Agreement will be minimally reviewed and re-approved by AMAG and PCI on a biennial basis.

Packaging Coordinators, Inc.		AMAG Pharmaceuticals, Inc
		100 Hayden Ave
3001 Red Lion Road		Lexington, MA 02421
Philadelphia, PA 19114


Quality Head- PCI		Quality Head- AMAG

Jeannie Metzinger, Vice President of Quality		Michelle Anastasi, Director, Quality Assurance

/s/ Jeannie Metzinger 5/13/2013		/s/ Michelle Anastasi 6/5/2013
Signature/Date		Signature/Date

For purposes of this Quality Agreement, the following definitions shall apply:

A. “API” shall mean the active pharmaceutical ingredient used in the manufacture of the Product as identified in the Specifications.

B. “Applicable Laws” means all laws, ordinances, rules and regulations within the Territory applicable to the Processing of the Product and the obligations of PCI or AMAG, as the context requires, including, without limitation, (i) all applicable federal, state and local laws and regulations of each Territory; (ii) the U.S. Federal Food, Drug and Cosmetic Act, and (iii) the “GMPs.” Applicable Laws shall also include all laws, ordinances, rules and regulations applicable in Territories added to this Quality Agreement after the Effective Date of this Agreement, solely to the extent AMAG or its designee has provided written copies of such laws to PCI prior to PCI’s Processing Product under this Quality Agreement. Copies of all laws shall be in the English language.

C. “Facility” means the PCI facilities located at:

3001 Red Lion Road	2200 Lake Shore Drive
Philadlephia, PA 19114	Woodstock, IL 60098

D. “FDA” shall mean the United States Food and Drug Administration, and any successor entity thereto.

E. “GMPs” mean the current Good Manufacturing Practices for Finished Pharmaceuticals promulgated by the FDA, as amended from time to time. GMPs shall also include good manufacturing practice regulations promulgated by a Regulatory Authority in a Territory added to this Agreement after the Effective Date of this Agreement, solely to the extent AMAG or its designee has provided written copies of such regulations to PCI prior to PCI’s Processing Product under this Quality Agreement. Copies of all laws shall be in the English language.

F. “Marketing Application” shall mean an application for marketing authorization which has not yet been approved by the FDA or other Regulatory Authority, including without limitation, FDA New Drug Application, FDA Abbreviated New Drug Application, and other similar marketing applications promulgated by Regulatory Authorities.

G. “Marketing Authorizations” shall mean any approved application for marketing authorization including without limitation, FDA New Drug Application, FDA Abbreviated New Drug Application, and other similar marketing applications promulgated by Regulatory Authorities.

H. “Packaging” means packaging the Product according to the Specifications.

I. “Process” or “Processing” means the sterile compounding, filling, producing and/or packaging of the Raw Materials into Product in accordance with the Specifications and the terms and conditions set forth in the Supply Agreement and this Quality Agreement.

J. “Product” shall mean the Product identified on the first page of this Quality Agreement.

K. “Regulatory Authority” shall mean the FDA and any other Regulatory Authority within a Territory involved in regulating any aspect of the development, manufacture, market approval, sale, distribution, packaging or use of the Product.

L. “Specifications” means the procedures, requirements, standards, quality control testing, other data and scope of services set forth in this Agreement.

M. “Standard Operating Procedures” shall mean the standard operating procedures in effect at PCI which have been approved by PCI Quality Assurance department and which are applicable to the Processing.

N. “Territories” shall mean the Unites States of America and any other country which the parties agree in writing to add to this Quality Agreement from time to time.

	Responsibilities	PCI	AMAG
1	COMPLIANCE REQUIREMENT
1.1	Package and hold the product (s) in accordance with cGMP, all applicable FDA requirements and/or applicable Regulatory Authorities	X
1.2	Welcome audits conducted by AMAG or its Partners at mutually agreed upon times of relevant premises, procedures and documentation as well as inspections by Regulatory Authorities	X
1.3	Refrain from subcontracting any of the work to a third party without AMAG’s prior written agreement	X
1.4	Will prepare, maintain and update the Marketing Authorization in accordance with all Applicable Laws and will communicate any changes affecting Packaging of the Product and otherwise as appropriate.		X
1.5	Will provide copies of those portions of the Marketing Application which are applicable to the Packaging of the Product prior to implementation or submission of such Marketing Application to the applicable Regulatory Authority.		X
1.6	Will promptly notify the other party in writing of any FDA or other Regulatory Authority investigation relating to Product manufacturing or Packaging at the Facilities.	X	X
1.7	Provide information in support of regulatory requirements in accordance with the terms of the applicable Service Agreement.	X
1.8	Notify AMAG and seek prior written approval of any proposed changes to the facilities, equipment, materials or testing that may directly impact the Services	X
1.9	Provide copies of any FDA Form 483, Warning Letter or other official communication from applicable regulatory agencies directly relating to the Services, Product or the facilities used to package or hold the Product within 3 business days of receipt as well as all subsequent responses	X
1.10	Notify PCI within 48 hours (2 business days) of any recall and/or confirmed stability failure of the Product that might be attributed to the packaging or storage of the product.		X
1.11	Reserves the right to recommend a recall to AMAG should a problem or issue become known that would affect the safety and efficacy of the Product.	X
1.12	Will be responsible for decision to initiate a recall or Product withdrawal after consultation with PCI.		X
1.13	Notify AMAG in writing within 48 hours (2 business days) of any applicable regulatory agency request for product samples, batch records, notice of inspections for any products supplied to AMAG and provide AMAG with daily summary reports of applicable	X

	Responsibilities	PCI	AMAG
	aspects of inspection.
1.14	Will be entitled to conduct quality audits of listed facilities any time Products are found to have significant quality issues. Max routine/requalification audits shall not exceed once per year.		X
1.15	Will conduct internal audit of quality control and quality assurance systems in accordance with the cGMP and applicable Standard Operating Procedures.	X
1.16	Warrant that it is not debarred under the U.S. Generic Drug Enforcement Act of 1992 and will not knowingly employ or use the services of any individual who is debarred or who has engaged in activities that could lead to being debarred.	X	X
1.17	Perform and maintain validations relevant to the Services in accordance with cGMP requirements and PCI requirements, including process and cleaning validations.	X
1.18	Mutually agree upon and approve all product specific protocols and validations.	X	X
1.19	Conduct operations in compliance with applicable environmental, occupational health and safety laws and regulations.	X
1.20	Assist AMAG in the investigation and resolution of medical and non-medical product complaints related to the Services within thirty days.	X
1.21	Notify AMAG of any requests for information, notices of violations or other communication from any government agency relating to environmental, occupational health and safety compliance, to the extent it may directly impact the Services.	X
1.22	Notify AMAG of any incident affecting compliance with environmental, occupational health and safety laws, to the extent they may directly impact Services.	X
1.23	Pull samples when requested for stability testing as defined in the approved Master Packaging Instructions.	X
1.24	Issue and follow up on FDA Field Alerts (commercial stability testing only). AMAG will notify PCI of the decision to initiate a regulatory action prior to notification to the agency whenever possible.		X
1.25	Perform the following responsibilities with regard to Complaints relating to Product or Services
	a. Collection and logging	X	X
	b. Investigation	X	X
	c. Issue of reports and follow-up corrective action	X	X
	d. Communicates decision to recall product to PCI		X
	e. Responsible for notification to appropriate regulatory agencies		X
	f. Responsible for management of product recall		X
	g. Responsible for reconciliation of returned product		X
1.26	Perform the following responsibilities to Regulatory Authorities
	Will act as primary liaison with appropriate Regulatory Authorities.		X
	Maintains relevant safety/hazard and handling data, if applicable.	X	X

	Responsibilities	PCI	AMAG
	Liaison with health and safety authorities	X	X
	Liaison with environmental protection authorities (pollution prevention)	X	X
1.27	Will meet all drug listing-filing requirements as communicated by AMAG to PCI for the Packaging of Product processed at the Facilities.	X
1.28	Will prepare and submit post-marketing annual reports to the FDA and the other Regulatory Authorities in accordance with Applicable Laws.		X
1.29	Will prepare an annual Product review and provide it to AMAG in support of AMAG’s annual Product report. The annual Product review shall be provided within 60 days of request and shall contain the following information: · Change control information for all changes implemented during the preceding year pertaining to the Product · List of Deviations · List of Customer Complaints · List of Quarantine Notices · List of Validations performed · Recommendations · Other information that may be reasonably required	X
1.30	Will review and approve the original Packaging (as applicable) master batch record for the Product.	X	X
1.31	Will provide supporting documentation for the NDA as requested.	X
1.32	Will review and approve change control documents for Packaging (as applicable) batch records prior to implementation.	X	X
2	PACKAGING
2.1	Will ensure that all specifications contained in the master batch record comply with the Marketing Authorization, as amended from time to time, and will certify such in writing to PCI.		X
2.2	Draft the Master Packaging Instructions (MPI) for product(s) in accordance with the product specifications and/or AMAG instructions. PCI will receive AMAG approval of the MPI from at least one AMAG Quality Assurance representative.	X	X
2.3	Utilize specification(s) developed for the product.	X
2.4	Will submit any changed proposed changes to the Specifications to the other appropriate party for review and approval prior to the implementation of such changes and the submission of any changes to the Regulatory Authorities.	X	X
2.5	Responsible for batch identification system for packaging product.	X	X
2.6	Responsible for qualification and approval of packaging components.		X
2.7	Responsible for approval of Packaging component suppliers. Responsibility will be assigned based on who is selecting the supplier for use.	X	X
2.8	Will be responsible for labeling the Product in accordance with the Specifications and applicable portions of 21 CFR 211.122 through 211.130.	X

	Responsibilities	PCI	AMAG
2.9	Will audit and qualify Packaging material suppliers providing Packaging material for the Product to ensure full compliance with the Specifications, cGMP Applicable Laws and Standard Operating Procedures.	X
2.10	PCI is responsible for maintenance of specifications, procurement, storage, sampling and testing and release of the packaging components and for obtaining AMAG approval of all documentation revisions.	X
2.11	Responsible for retaining reference samples of labeling, and packaging components, for at least (1) year beyond expiration date assigned to the batch.	X
2.12	Will pull and store retain samples during Packaging as required in the approved Packaging batch records. PCI will pull and send Product reserve samples as directed by AMAG. AMAG is responsible for determining the amount of reserve samples required and communicating the quantity to PCI	X	X
2.13	Responsible to perform maintenance, qualification and validation of the facility, equipment and processes associated with the packaging of the product.	X
2.14	May be present during Process validation activities.		X
2.15	PCI is responsible to perform sampling and release of packaged Product in accordance with the Product specification and to supply a Certificate of Release to AMAG. AMAG is responsible for final product release to market.(Responsibility will be defined as per specifics of the contract.)	X	X
2.16	Will assign Product lot codes and expiration dates as appropriate to Packaging, on a lot-by-lot basis, in accordance with Standard Operating Procedures.		X
2.17	Responsible for investigation, resolution and documentation of all events not conforming to approved MPI or specifications. All such investigations shall be recorded and approved within thirty days unless PCI notifies AMAG that such investigation will exceed thirty days. All such investigations shall be reviewed and approved by AMAG.	X	X
2.18	Will review and approve all deviation reports for Packaging (as applicable). Copies of the deviation reports will be provided with the batch documentation.	X	X
2.19	Will promptly notify AMAG of any deviations or failures related to Packaging (as applicable) within 2 business days. If there is a confirmed deviation, processing of additional lots shall be discontinued until a common agreement is reached regarding the impact and approach to be followed.	X
2.20	Maintain batch records for the minimum period required by applicable laws and supply a copy of such batch records to AMAG at time of release.	X
2.21	Will maintain safety/hazard and handling data for new products and materials in accordance with the Specifications.	X	X
2.22	Validation batch production and testing records shall be kept for	X

	Responsibilities	PCI	AMAG
	the minimum period required by applicable laws.
2.23	Will perform all appropriate in-process testing as agreed upon and required by the Packaging master batch record pertaining to the Packaging of the Product.	X
2.24	Will be responsible for releasing of the Product to PCI’s Packaging Facilities.		X
2.25	Will be responsible for releasing the Product to the market in accordance with the Specifications.		X
2.26	Will provide all necessary support and documents as may be appropriate to issue and follow up on FDA Field Alerts or similar matters from applicable Regulatory Authorities.	X
3	STORAGE AND TRANSPORTATION OF BULK PRODUCT AND WASTE DISPOSAL
3.1	Provide PCI with authorized ship “from” location(s). Provide PCI with authorized ship “to” delivery location(s).		X
3.2	Provide PCI with shipping conditions to PCI (temperature/RH, as applicable) and other special shipping requirements i.e.: receiving instructions, usage of dataloggers, etc.		X
3.3	Provide PCI with shipping conditions to specified delivery location(s) (temperature/RH, as applicable) and other special shipping requirements i.e.: receiving instructions, usage of dataloggers, etc.		X
3.4	Define Product storage and in-process Packaging requirements(temperature/RH, as applicable) within warehouse and production areas and agreed to by PCI.	X	X
3.5	Arrange for transportation of Product as requested by AMAG.	X	X
3.6	Provide for customs formalities and freight forwarding.		X
3.7	Insurance for transportation of Product		X
3.8	Will be responsible for handling all Product returns in accordance with AMAG standard operating procedures.		X
4	DOCUMENTATION
4.1	Provide complete batch documentation with all associated deviations and a QA representative signed Certificates of Release and cGMP Compliance.	X
4.2	Reconciliation and accountability for all labeling and specified Packaging components as required by the MPI after all critical process steps. Any reconciliation outside pre-established limits must be investigated and a copy of the investigation included in the batch record.	X

Exhibit 10.3

AMAG PHARMACEUTICALS, INC.

INCENTIVE STOCK OPTION AGREEMENT

FOR COMPANY EMPLOYEES

Name of Optionee:

No. of Option Shares:

Option Exercise Price per Share:	$
	[FMV on Grant Date ]

Grant Date:	, 2013

Expiration Date:
	[up to 10 years]

Pursuant to the AMAG Pharmaceuticals, Inc. Third Amended and Restated 2007 Equity Incentive Plan as amended through the date hereof (the “Plan”), AMAG Pharmaceuticals, Inc. (the “Company”) hereby grants to the Optionee named above an option (the “Stock Option”) to purchase on or prior to the Expiration Date specified above all or part of the number of shares of Common Stock, par value $0.01 per share (the “Stock”), of the Company specified above at the Option Exercise Price per Share specified above subject to the terms and conditions set forth herein and in the Plan.

1. Exercisability Schedule . No portion of this Stock Option may be exercised until such portion shall have become exercisable. Except as set forth below, and subject to the discretion of the Administrator (as defined in Section 2 of the Plan) to accelerate the exercisability schedule hereunder, this Stock Option shall be exercisable with respect to the following number of Option Shares on the dates indicated so long as the Optionee remains in a Business Relationship (as defined in Section 3 below) on such dates:

Incremental Number of Option Shares Exercisable*		Exercisability Date
(	)%
(	)%
(	)%
(	)%

* Max. of $100,000 per yr.

Once exercisable, this Stock Option shall continue to be exercisable at any time or times prior to the close of business on the Expiration Date, subject to the provisions hereof and of the Plan.

2. Manner of Exercise .

(a) The Optionee may exercise this Stock Option only in the following manner: from time to time on or prior to the Expiration Date of this Stock Option, the Optionee may give written or electronic notice to the Company to the attention of the Company’s Treasurer or his or her designee of his or her election to purchase some or all of the Option Shares purchasable at the time of such notice. This notice shall specify the number of Option Shares to be purchased.

Payment of the purchase price for the Option Shares may be made by one or more of the following methods: (i) in cash, by certified or bank check or other instrument acceptable to the Company; (ii) subject to the Company’s approval, through the delivery (or attestation to the ownership) of shares of Stock that have been purchased by the Optionee on the open market or that are beneficially owned by the Optionee and are not then subject to any restrictions under any Company plan and that otherwise satisfy any holding periods as may be required by the Administrator; (iii) by the Optionee delivering to the Company a properly executed exercise notice together with irrevocable instructions to a broker to promptly deliver to the Company cash or a check payable and acceptable to the Company to pay the option purchase price, provided that in the event the Optionee chooses to pay the option purchase price as so provided, the Optionee and the broker shall comply with such procedures and enter into such agreements of indemnity and other agreements as the Company shall prescribe as a condition of such payment procedure; or (iv) a combination of (i), (ii) and (iii) above. Payment instruments will be received subject to collection.

The transfer to the Optionee on the records of the Company or of the transfer agent of the Option Shares will be contingent upon (i) the Company’s receipt from the Optionee of the full purchase price for the Option Shares, as set forth above, (ii) the fulfillment of any other requirements contained herein or in the Plan or in any other agreement or provision of laws, and (iii) the receipt by the Company of any agreement, statement or other evidence that the Company may require to satisfy itself that the issuance of Stock to be purchased pursuant to the exercise of Stock Options under the Plan and any subsequent resale of the shares of Stock will be in compliance with applicable laws and regulations. In the event the Optionee chooses to pay the purchase price by previously-owned shares of Stock through the attestation method, the number of shares of Stock transferred to the Optionee upon the exercise of the Stock Option shall be net of the Shares attested to.

(b) The shares of Stock purchased upon exercise of this Stock Option shall be transferred to the Optionee on the records of the Company or of the transfer agent upon compliance to the satisfaction of the Company with all requirements under applicable laws or regulations in connection with such transfer and with the requirements hereof and of the Plan. The determination of the Company as to such compliance shall be final and binding on the Optionee. The Optionee shall not be deemed to be the holder of, or to have any of the rights of a holder with respect to, any shares of Stock subject to this Stock Option unless and until this Stock Option shall have been exercised pursuant to the terms hereof, the Company or the transfer

agent shall have transferred the shares to the Optionee, and the Optionee’s name shall have been entered as the stockholder of record on the books of the Company. Thereupon, the Optionee shall have full voting, dividend and other ownership rights with respect to such shares of Stock.

(c) Notwithstanding any other provision hereof or of the Plan, no portion of this Stock Option shall be exercisable after the Expiration Date hereof.

(d) Without derogating from the foregoing, “statutory option stock” (as defined below) may be tendered in payment of the exercise price of this Stock Option even if the stock to be so tendered has not, at the time of tender, been held by the Optionee for the applicable minimum statutory holding period required to receive the tax benefits afforded under Section 421(a) of the Code with respect to such stock. The Optionee acknowledges that the tender of such “statutory option stock” may have adverse tax consequences to the Optionee. As used above, the term “statutory option stock” means stock acquired through the exercise of an incentive stock option or an option granted under an employee stock purchase plan. The tender of statutory option stock in payment of the exercise price of this Option shall be accompanied by written representation (in form satisfactory to the Company) stating whether such stock has been held by the Optionee for the applicable minimum statutory holding period.

3. Termination of Business Relationship .

(a) If the Optionee’s Business Relationship (as defined below) is terminated, the period within which to exercise the Stock Option may be subject to earlier termination as follows:

(i) If the Optionee’s Business Relationship is terminated by reason of the Optionee’s death or disability (as determined by the Company) or, if the Optionee dies or becomes disabled within the three-month period following the date the Optionee’s Business Relationship terminates for any other reason, any portion of this Stock Option outstanding on the date of termination, may be exercised, to the extent exercisable on such date, for a period of twelve months from the date of death or disability or until the Expiration Date, if earlier. Any portion of this Stock Option that is not exercisable on the date the Optionee’s Business Relationship is terminated shall terminate immediately and be of no further force or effect.

(ii) If the Optionee’s Business Relationship is terminated for any reason other than death or disability, any portion of this Stock Option outstanding on such date may be exercised, to the extent exercisable on the date of termination, for a period of three months from the date of termination or until the Expiration Date, if earlier. Any portion of this Stock Option that is not exercisable on the date the Optionee’s Business Relationship is terminated shall terminate immediately and be of no further force or effect.

(iii) Notwithstanding the foregoing, if the Optionee, prior to the termination date of this Stock Option, (i) violates any provision of any employment agreement or any confidentiality or other agreement between the Optionee and the Company, (ii) commits any felony or any crime involving moral turpitude under the laws of the United States or any state thereof, (iii) attempts to commit, or participate in, a fraud

or act of dishonesty against the Company, or (iv) commits gross misconduct, the right to exercise this Stock Option shall terminate immediately upon written notice to the Optionee from the Company describing such violation or act.

The Company’s determination of the reason for termination of the Optionee’s Business Relationship shall be conclusive and binding on the Optionee and his or her representatives or legatees. Notwithstanding the foregoing, under certain circumstances set forth in the Employment Agreement dated as of , 2013 by and between the Company and the Grantee (the “Employment Agreement”), and subject to compliance by the Grantee with the requirements of the Employment Agreement related to such circumstances, the vesting of unvested Restricted Stock Units may be accelerated as provided in and subject to the terms of the Employment Agreement.

(b) For purposes hereof, “Business Relationship” means service to the Company or any of its Subsidiaries, or its or their successors, in the capacity of an employee, officer, director, consultant or advisor. For purposes hereof, a Business Relationship shall not be considered as having terminated during any military leave, sick leave, or other leave of absence if approved in writing by the Company and if such written approval, or applicable law, contractually obligates the Company to continue the Business Relationship of the Optionee after the approved period of absence (an “Approved Leave of Absence”). In the event of an Approved Leave of Absence, vesting of this Stock Option shall be suspended (and all subsequent vesting dates shall be postponed by the length of the period of the Approved Leave of Absence) unless otherwise provided in the Company’s written approval of the leave of absence. For purposes hereof, a Business Relationship shall include a consulting arrangement between the Optionee and the Company that immediately follows termination of employment, but only if so stated in a written consulting agreement executed by the Company.

4. Incorporation of Plan . Notwithstanding anything herein to the contrary, this Stock Option shall be subject to and governed by all the terms and conditions of the Plan, including the powers of the Administrator set forth in Section 2(b) of the Plan. Capitalized terms in this Agreement shall have the meaning specified in the Plan, unless a different meaning is specified herein.

5. Transferability . This Agreement is personal to the Optionee, is non-assignable and is not transferable in any manner, by operation of law or otherwise, other than by will or the laws of descent and distribution. This Stock Option is exercisable, during the Optionee’s lifetime, only by the Optionee, and thereafter, only by the Optionee’s legal representative or legatee. Notwithstanding the foregoing, this Stock Option may be transferred pursuant to a domestic relations order; provided, however, that an “incentive stock option” under Section 422 of the Internal Revenue Code of 1986, as amended (the “Code”) may be deemed to be a nonqualified stock option as a result of such transfer.

6. Status of the Stock Option . This Stock Option is intended to qualify as an “incentive stock option” under Section 422 of the Code, but the Company does not represent or warrant that this Stock Option qualifies as such. The Optionee should consult with his or her own tax advisors regarding the tax effects of this Stock Option and the requirements necessary to obtain favorable income tax treatment under Section 422 of the Code, including, but not limited to, holding period requirements. To the extent any portion of this Stock Option does not so

qualify as an “incentive stock option,” such portion shall be deemed to be a non-qualified stock option. If the Optionee intends to dispose or does dispose (whether by sale, gift, transfer or otherwise) of any Option Shares within the one-year period beginning on the date after the transfer of such shares to him or her, or within the two-year period beginning on the day after the grant of this Stock Option, he or she will so notify the Company within 30 days after such disposition.

7. Tax Withholding . The Optionee shall, not later than the date as of which the exercise of this Stock Option becomes a taxable event for Federal income tax purposes, pay to the Company or make arrangements satisfactory to the Company for payment of any Federal, state, and local taxes required by law to be withheld on account of such taxable event. The Company shall have the authority to cause the minimum required tax withholding obligation to be satisfied, in whole or in part, by withholding from shares of Stock to be issued to the Optionee a number of shares of Stock with an aggregate Fair Market Value that would satisfy the minimum withholding amount due.

8. No Obligation to Continue Business Relationship . Neither the Company nor any Subsidiary is obligated by or as a result of the Plan or this Agreement to continue the Optionee’s Business Relationship, and neither the Plan nor this Agreement shall interfere in any way with the right of the Company or any Subsidiary to terminate the Business Relationship of the Optionee at any time.

9. Integration . This Agreement constitutes the entire agreement between the parties with respect to this Stock Option and supersedes all prior agreements and discussions between the parties concerning such subject matter.

10. Data Privacy Consent . In order to administer the Plan and this Agreement and to implement or structure future equity grants, the Company, its subsidiaries and affiliates and certain agents thereof (together, the “Relevant Companies”) may process any and all personal or professional data, including but not limited to Social Security or other identification number, home address and telephone number, date of birth and other information that is necessary or desirable for the administration of the Plan and/or this Agreement (the “Relevant Information”). By entering into this Agreement, the Optionee (i) authorizes the Company to collect, process, register and transfer to the Relevant Companies all Relevant Information; (ii) waives any privacy rights the Optionee may have with respect to the Relevant Information; (iii) authorizes the Relevant Companies to store and transmit such information in electronic form; and (iv) authorizes the transfer of the Relevant Information to any jurisdiction in which the Relevant Companies consider appropriate. The Optionee shall have access to, and the right to change, the Relevant Information. Relevant Information will only be used in accordance with applicable law.

11. Notices . Notices hereunder shall be mailed or delivered to the Company at its principal place of business to the attention of the Company’s Treasurer and shall be mailed or delivered to the Optionee at the address on file with the Company or, in either case, at such other address as one party may subsequently furnish to the other party in writing.

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

SIGNATURE PAGE TO AMAG PHARMACEUTICALS, INC.

INCENTIVE STOCK OPTION AGREEMENT

AMAG PHARMACEUTICALS, INC.


By:
	Name:	William K. Heiden
	Title:	President and CEO

The foregoing Agreement is hereby accepted and the terms and conditions thereof hereby agreed to by the undersigned, and the undersigned acknowledges receipt of a copy of this entire Agreement, a copy of the Plan, and a copy of the Plan’s related prospectus. Electronic acceptance of this Agreement pursuant to the Company’s instructions to the Optionee (including through an online acceptance process) is acceptable.

Dated:	, 2013
		Optionee’s Signature

		Optionee’s name and address:

Exhibit 10.4

AMAG PHARMACEUTICALS, INC.

NON-QUALIFIED STOCK OPTION AGREEMENT
FOR COMPANY EMPLOYEES

Name of Optionee:

No. of Option Shares:

Option Exercise Price per Share:	$
	[FMV on Grant Date]

Grant Date:	, 2013

Expiration Date:
	[ up to 10 years ]

Pursuant to the AMAG Pharmaceuticals, Inc. Third Amended and Restated 2007 Equity Incentive Plan as amended through the date hereof (the “Plan”), AMAG Pharmaceuticals, Inc. (the “Company”) hereby grants to the Optionee named above an option (the “Stock Option”) to purchase on or prior to the Expiration Date specified above all or part of the number of shares of Common Stock, par value $0.01 per share (the “Stock”) of the Company specified above at the Option Exercise Price per Share specified above subject to the terms and conditions set forth herein and in the Plan. This Stock Option is not intended to be an “incentive stock option” under Section 422 of the Internal Revenue Code of 1986, as amended.

Incremental Number of Option Shares Exercisable		Exercisability Date
(	)%
(	)%
(	)%
(	)%

Once exercisable, this Stock Option shall continue to be exercisable at any time or times prior to the close of business on the Expiration Date, subject to the provisions hereof and of the Plan.

2. Manner of Exercise .

Stock Option shall have been exercised pursuant to the terms hereof, the Company or the transfer agent shall have transferred the shares to the Optionee, and the Optionee’s name shall have been entered as the stockholder of record on the books of the Company. Thereupon, the Optionee shall have full voting, dividend and other ownership rights with respect to such shares of Stock.

(c) Notwithstanding any other provision hereof or of the Plan, no portion of this Stock Option shall be exercisable after the Expiration Date hereof.

3. Termination of Business Relationship .

(a) If the Optionee’s Business Relationship (as defined below) is terminated, the period within which to exercise the Stock Option may be subject to earlier termination as follows:

Company, (ii) commits any felony or any crime involving moral turpitude under the laws of the United States or any state thereof, (iii) attempts to commit, or participate in, a fraud or act of dishonesty against the Company, or (iv) commits gross misconduct, the right to exercise this Stock Option shall terminate immediately upon written notice to the Optionee from the Company describing such violation or act.

The Company’s determination of the reason for termination of the Optionee’s Business Relationship shall be conclusive and binding on the Optionee and his or her representatives or legatees. Notwithstanding the foregoing, under certain circumstances set forth in the Employment Agreement dated as of , 2013 by and between the Company and the Optionee (the “Employment Agreement”), and subject to compliance by the Optionee with the requirements of the Employment Agreement related to such circumstances, the vesting of the unvested portion of this Stock Option may be accelerated as provided in and subject to the terms of the Employment Agreement.

6. Tax Withholding . The Optionee shall, not later than the date as of which the exercise of this Stock Option becomes a taxable event for Federal income tax purposes, pay to the Company or make arrangements satisfactory to the Company for payment of any Federal, state, and local taxes required by law to be withheld on account of such taxable event. The Company shall have the authority to cause the minimum required tax withholding obligation to

be satisfied, in whole or in part, by withholding from shares of Stock to be issued to the Optionee a number of shares of Stock with an aggregate Fair Market Value that would satisfy the minimum withholding amount due.

7. No Obligation to Continue Business Relationship . Neither the Company nor any Subsidiary is obligated by or as a result of the Plan or this Agreement to continue the Optionee’s Business Relationship, and neither the Plan nor this Agreement shall interfere in any way with the right of the Company or any Subsidiary to terminate the Business Relationship of the Optionee at any time.

8. Integration . This Agreement constitutes the entire agreement between the parties with respect to this Stock Option and supersedes all prior agreements and discussions between the parties concerning such subject matter.

9. Data Privacy Consent . In order to administer the Plan and this Agreement and to implement or structure future equity grants, the Company, its subsidiaries and affiliates and certain agents thereof (together, the “Relevant Companies”) may process any and all personal or professional data, including but not limited to Social Security or other identification number, home address and telephone number, date of birth and other information that is necessary or desirable for the administration of the Plan and/or this Agreement (the “Relevant Information”). By entering into this Agreement, the Optionee (i) authorizes the Company to collect, process, register and transfer to the Relevant Companies all Relevant Information; (ii) waives any privacy rights the Optionee may have with respect to the Relevant Information; (iii) authorizes the Relevant Companies to store and transmit such information in electronic form; and (iv) authorizes the transfer of the Relevant Information to any jurisdiction in which the Relevant Companies consider appropriate. The Optionee shall have access to, and the right to change, the Relevant Information. Relevant Information will only be used in accordance with applicable law.

10. Notices . Notices hereunder shall be mailed or delivered to the Company at its principal place of business to the attention of the Company’s Treasurer and shall be mailed or delivered to the Optionee at the address on file with the Company or, in either case, at such other address as one party may subsequently furnish to the other party in writing.

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SIGNATURE PAGE TO AMAG PHARMACEUTICALS, INC.

NON-QUALIFIED STOCK OPTION AGREEMENT

AMAG PHARMACEUTICALS, INC.


By:
	Name:	William K. Heiden
	Title:	President and CEO

Dated:	, 2013
		Optionee’s Signature


		Optionee’s name and address:

Exhibit 10.5

AMAG PHARMACEUTICALS, INC.

RESTRICTED STOCK UNIT AWARD AGREEMENT
FOR COMPANY EMPLOYEES

Name of Grantee:

No. of Restricted Stock Units:

Grant Date:	, 2013

Pursuant to the AMAG Pharmaceuticals, Inc. Third Amended and Restated 2007 Equity Incentive Plan as amended through the date hereof (the “Plan”), AMAG Pharmaceuticals, Inc. (the “Company”) hereby grants an award of the number of Restricted Stock Units listed above (an “Award”) to the Grantee named above. Each Restricted Stock Unit shall relate to one share of Common Stock, par value $0.01 per share (the “Stock”) of the Company.

1. Restrictions on Transfer of Award . This Award may not be sold, transferred, pledged, assigned or otherwise encumbered or disposed of by the Grantee, and any shares of Stock issuable with respect to the Award may not be sold, transferred, pledged, assigned or otherwise encumbered or disposed of until (i) the Restricted Stock Units have vested as provided in Section 2 of this Agreement and (ii) shares of Stock have been issued to the Grantee in accordance with the terms of the Plan and this Agreement.

2. Vesting of Restricted Stock Units . The restrictions and conditions of Section 1 of this Agreement shall lapse on the Vesting Date or Dates specified in the following schedule so long as the Grantee remains in a Business Relationship (as defined in Section 3 below) on such Dates. If a series of Vesting Dates is specified, then the restrictions and conditions in Section 1 shall lapse only with respect to the number of Restricted Stock Units specified as vested on such date.

Incremental Number of Restricted Stock Units Vested		Vesting Date
(	)%
(	)%
(	)%
(	)%

The Administrator may at any time accelerate the vesting schedule specified in this Section 2.

3. Termination of Business Relationship .

(a) If the Grantee’s Business Relationship terminates for any reason (including death or disability) prior to the satisfaction of the vesting conditions set forth in Section 2 above, any Restricted Stock Units that have not vested as of such date shall automatically and without notice terminate and be forfeited, and neither the Grantee nor any of his or her successors, heirs, assigns, or personal representatives will thereafter have any further rights or interests in such unvested Restricted Stock Units. Notwithstanding the foregoing, under certain circumstances set forth in the Employment Agreement dated as of , 2013 by and between the Company and the Grantee (the “Employment Agreement”), and subject to compliance by the Grantee with the requirements of the Employment Agreement related to such circumstances, the vesting of unvested Restricted Stock Units may be accelerated as provided in and subject to the terms of the Employment Agreement.

(b) “Business Relationship” means service to the Company or any of its Subsidiaries, or its or their successors, in the capacity of an employee, officer, director, consultant or advisor. For purposes hereof, a Business Relationship shall not be considered as having terminated during any military leave, sick leave, or other leave of absence if approved in writing by the Company and if such written approval, or applicable law, contractually obligates the Company to continue the Business Relationship of the Grantee after the approved period of absence (an “Approved Leave of Absence”). In the event of an Approved Leave of Absence, vesting of Restricted Stock Units shall be suspended (and all subsequent vesting dates shall be postponed by the length of the period of the Approved Leave of Absence) unless otherwise provided in the Company’s written approval of the leave of absence. For purposes hereof, a Business Relationship shall include a consulting arrangement between the Grantee and the Company that immediately follows termination of employment, but only if so stated in a written consulting agreement executed by the Company.

4. Issuance of Shares of Stock . As soon as practicable following each Vesting Date (but in no event later than two and one-half months after the end of the year in which the Vesting Date occurs), the Company shall issue to the Grantee the number of shares of Stock equal to the aggregate number of Restricted Stock Units that have vested pursuant to Section 2 of this Agreement on such date and the Grantee shall thereafter have all the rights of a stockholder of the Company with respect to such shares.

5. Incorporation of Plan . Notwithstanding anything herein to the contrary, this Agreement shall be subject to and governed by all the terms and conditions of the Plan, including the powers of the Administrator set forth in Section 2(b) of the Plan. Capitalized terms in this Agreement shall have the meaning specified in the Plan, unless a different meaning is specified herein.

6. Tax Withholding . The Grantee shall, not later than the date as of which the receipt of this Award becomes a taxable event for Federal income tax purposes, pay to the Company or make arrangements satisfactory to the Company for payment of any Federal, state, and local taxes required by law to be withheld on account of such taxable event. The Company shall have the authority to cause the minimum required tax withholding obligation to be satisfied, in whole or in part, by withholding from shares of Stock to be issued to the Grantee a number of shares of Stock with an aggregate Fair Market Value that would satisfy the minimum withholding amount due.

7. Section 409A of the Code. This Agreement shall be interpreted in such a manner that all provisions relating to the settlement of the Award are exempt from the requirements of Section 409A of the Code as “short-term deferrals” as described in Section 409A of the Code.

8. No Obligation to Continue Business Relationship . Neither the Company nor any Subsidiary is obligated by or as a result of the Plan or this Agreement to continue the Grantee’s Business Relationship, and neither the Plan nor this Agreement shall interfere in any way with the right of the Company or any Subsidiary to terminate the Business Relationship of the Grantee at any time.

9. Integration . This Agreement constitutes the entire agreement between the parties with respect to this Award and supersedes all prior agreements and discussions between the parties concerning such subject matter.

10. Data Privacy Consent . In order to administer the Plan and this Agreement and to implement or structure future equity grants, the Company, its subsidiaries and affiliates and certain agents thereof (together, the “Relevant Companies”) may process any and all personal or professional data, including but not limited to Social Security or other identification number, home address and telephone number, date of birth and other information that is necessary or desirable for the administration of the Plan and/or this Agreement (the “Relevant Information”). By entering into this Agreement, the Grantee (i) authorizes the Company to collect, process, register and transfer to the Relevant Companies all Relevant Information; (ii) waives any privacy rights the Grantee may have with respect to the Relevant Information; (iii) authorizes the Relevant Companies to store and transmit such information in electronic form; and (iv) authorizes the transfer of the Relevant Information to any jurisdiction in which the Relevant Companies consider appropriate. The Grantee shall have access to, and the right to change, the Relevant Information. Relevant Information will only be used in accordance with applicable law.

11. Notices . Notices hereunder shall be mailed or delivered to the Company at its principal place of business to the attention of the Company’s Treasurer and shall be mailed or delivered to the Grantee at the address on file with the Company or, in either case, at such other address as one party may subsequently furnish to the other party in writing.

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SIGNATURE PAGE TO AMAG PHARMACEUTICALS, INC.

RESTRICTED STOCK UNIT AWARD AGREEMENT

AMAG PHARMACEUTICALS, INC.


By:
	Name:	William K. Heiden
	Title:	President and CEO

The foregoing Agreement is hereby accepted and the terms and conditions thereof hereby agreed to by the undersigned, and the undersigned acknowledges receipt of a copy of this entire Agreement, a copy of the Plan, and a copy of the Plan’s related prospectus. Electronic acceptance of this Agreement pursuant to the Company’s instructions to the Grantee (including through an online acceptance process) is acceptable.

Dated:	, 2013
		Grantee’s Signature


		Grantee’s name and address:

Exhibit 10.10

AMAG PHARMACEUTICALS, INC.

NON-QUALIFIED STOCK OPTION AGREEMENT
FOR NON-EMPLOYEE DIRECTORS

Name of Optionee:

No. of Option Shares:

Option Exercise Price per Share:	$
	[FMV on Grant Date]

Grant Date:	, 2013

Expiration Date:
	[No more than 10 years]

Pursuant to the AMAG Pharmaceuticals, Inc. Third Amended and Restated 2007 Equity Incentive Plan as amended through the date hereof (the “Plan”), AMAG Pharmaceuticals, Inc. (the “Company”) hereby grants to the Optionee named above, who is a Director of the Company but is not an employee of the Company, an option (the “Stock Option”) to purchase on or prior to the Expiration Date specified above all or part of the number of shares of Common Stock, par value $0.01 per share (the “Stock”), of the Company specified above at the Option Exercise Price per Share specified above subject to the terms and conditions set forth herein and in the Plan. This Stock Option is not intended to be an “incentive stock option” under Section 422 of the Internal Revenue Code of 1986, as amended.

1. Exercisability Schedule . No portion of this Stock Option may be exercised until such portion shall have become exercisable. Except as set forth below, and subject to the discretion of the Administrator (as defined in Section 2 of the Plan) to accelerate the exercisability schedule hereunder, this Stock Option shall be exercisable with respect to the following number of Option Shares on the dates indicated so long as the Optionee maintains a Business Relationship with the Company (as defined below) on such dates:

Incremental Number of Option Shares Exercisable		Exercisability Date

[1/12 of [Number]]		June 1, 20XX
[1/12 of [Number]]		July 1, 20XX
[1/12 of [Number]]		August 1, 20XX
[1/12 of [Number]]		September 1, 20XX
[1/12 of [Number]]		October 1, 20XX
[1/12 of [Number]]		November 1, 20XX
[1/12 of [Number]]		December 1, 20XX

[1/12 of [Number]]		January 1, 20XX
[1/12 of [Number]]		February 1, 20XX
[1/12 of [Number]]		March 1, 20XX
[1/12 of [Number]]		April 1, 20XX
[1/12 of [Number]]		May 1, 20XX

Once exercisable, this Stock Option shall continue to be exercisable at any time or times prior to the close of business on the Expiration Date, subject to the provisions hereof and of the Plan.

“Business Relationship” means service to the Company or its successor in the capacity of an employee, officer, director, consultant, or advisor.

2. Manner of Exercise .

of shares of Stock transferred to the Optionee upon the exercise of the Stock Option shall be net of the Shares attested to.

(c) Notwithstanding any other provision hereof or of the Plan, no portion of this Stock Option shall be exercisable after the Expiration Date hereof.

3. Termination of Business Relationship .

(a) If the Optionee ceases to maintain a Business Relationship with the Company, the period within which to exercise the Stock Option may be subject to earlier termination as follows:

(i) If the Optionee ceases to maintain a Business Relationship with the Company by reason of the Optionee’s death or disability (as determined by the Company) or, if the Optionee dies or becomes disabled within the three-month period following the date the Optionee ceases to maintain a Business Relationship with the Company, any portion of this Stock Option outstanding on the date the Optionee ceases to maintain a Business Relationship with the Company, may be exercised, to the extent exercisable on such date, for a period of three years from the date of death or disability or until the Expiration Date, if earlier. Any portion of this Stock Option that is not exercisable on the date the Optionee ceases to maintain a Business Relationship with the Company shall terminate immediately and be of no further force or effect.

(ii) If the Optionee ceases to maintain a Business Relationship with the Company for any reason other than death or disability, any portion of this Stock Option outstanding on such date may be exercised, to the extent exercisable on such date, for a period of three years from the date the Optionee ceased to maintain a Business Relationship with the Company or until the Expiration Date, if earlier. Any portion of this Stock Option that is not exercisable on the date the Optionee ceases to maintain a Business Relationship with the Company shall terminate immediately and be of no further force or effect.

(iii) Notwithstanding the foregoing, if the Optionee, prior to the termination date of this Stock Option, (i) violates any provision of any confidentiality, consulting or other agreement between the Optionee and the Company, (ii) commits any

felony or any crime involving moral turpitude under the laws of the United States or any state thereof, (iii) attempts to commit, or participate in, a fraud or act of dishonesty against the Company, or (iv) commits gross misconduct, the right to exercise this Stock Option shall terminate immediately upon written notice to the Optionee from the Company describing such violation or act.

6. No Obligation to Continue Service . Neither the Plan nor this Stock Option confers upon the Optionee any rights with respect to continued service as a member of the Board or to the Company.

7. Integration . This Agreement constitutes the entire agreement between the parties with respect to this Stock Option and supersedes all prior agreements and discussions between the parties concerning such subject matter.

8. Data Privacy Consent . In order to administer the Plan and this Agreement and to implement or structure future equity grants, the Company, its subsidiaries and affiliates and certain agents thereof (together, the “Relevant Companies”) may process any and all personal or professional data, including but not limited to Social Security or other identification number, home address and telephone number, date of birth and other information that is necessary or desirable for the administration of the Plan and/or this Agreement (the “Relevant Information”). By entering into this Agreement, the Optionee (i) authorizes the Company to collect, process, register and transfer to the Relevant Companies all Relevant Information; (ii) waives any privacy rights the Optionee may have with respect to the Relevant Information; (iii) authorizes the Relevant Companies to store and transmit such information in electronic form; and (iv) authorizes the transfer of the Relevant Information to any jurisdiction in which the Relevant Companies consider appropriate. The Optionee shall have access to, and the right to change, the Relevant Information. Relevant Information will only be used in accordance with applicable law.

9. Notices . Notices hereunder shall be mailed or delivered to the Company at its principal place of business to the attention of the Company’s Treasurer and shall be mailed or delivered to the Optionee at the address on file with the Company or, in either case, at such other address as one party may subsequently furnish to the other party in writing.

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	AMAG PHARMACEUTICALS, INC.


	By:
		Name:	William K. Heiden
		Title:	President and CEO

Dated:	, 2013
		Optionee’s Signature


		Optionee’s name and address:

Exhibit 10.11

AMAG PHARMACEUTICALS, INC.

RESTRICTED STOCK UNIT AWARD AGREEMENT
FOR NON-EMPLOYEE DIRECTORS

Name of Grantee:

No. of Restricted Stock Units:

Grant Date:		, 2013

Pursuant to the AMAG Pharmaceuticals, Inc. Third Amended and Restated 2007 Equity Incentive Plan as amended through the date hereof (the “Plan”), AMAG Pharmaceuticals, Inc. (the “Company”) hereby grants an award of the number of Restricted Stock Units listed above (an “Award”) to the Grantee named above. Each Restricted Stock Unit shall relate to one share of Common Stock, par value $0.01 per share (the “Stock”) of the Company.

2. Vesting of Restricted Stock Units . The restrictions and conditions of Section 1 of this Agreement shall lapse on the Vesting Date or Dates specified in the following schedule so long as the Grantee maintains a Business Relationship with the Company (as defined below) on such Dates. If a series of Vesting Dates is specified, then the restrictions and conditions in Section 1 of this Agreement shall lapse only with respect to the number of Restricted Stock Units specified as vested on such date.

Incremental Number of Restricted Stock Units Vested		Vesting Date

[1/12 of [Number]]		June 1, 20XX
[1/12 of [Number]]		July 1, 20XX
[1/12 of [Number]]		August 1, 20XX
[1/12 of [Number]]		September 1, 20XX
[1/12 of [Number]]		October 1, 20XX
[1/12 of [Number]]		November 1, 20XX
[1/12 of [Number]]		December 1, 20XX
[1/12 of [Number]]		January 1, 20XX
[1/12 of [Number]]		February 1, 20XX
[1/12 of [Number]]		March 1, 20XX

[1/12 of [Number]]		April 1, 20XX
[1/12 of [Number]]		May 1, 20XX

The Administrator may at any time accelerate the vesting schedule specified in this Section 2.

“Business Relationship” means service to the Company or its successor in the capacity of an employee, officer, director, consultant, or advisor.

3. Termination of Business Relationship . If the Grantee ceases to maintain a Business Relationship with the Company for any reason (including death or disability) prior to the satisfaction of the vesting conditions set forth in Section 2 above, any Restricted Stock Units that have not vested as of such date shall automatically and without notice terminate and be forfeited, and neither the Grantee nor any of his or her successors, heirs, assigns, or personal representatives will thereafter have any further rights or interests in such unvested Restricted Stock Units.

4. Issuance of Shares of Stock . The Company shall issue to the Grantee, on the earlier of (a) the third anniversary of the Grant Date or (b) as soon as practicable (but not later than 90 days) following the date of termination of the Grantee’s service, provided that such termination constitutes a “separation from service” as such term is defined in Treasury Regulation Section 1.409A-1(h), (in either case, the “ Delivery Date ”), the number of shares of Stock equal to the aggregate number of Restricted Stock Units that have vested pursuant to Section 2 of this Agreement, provided that, if the Delivery Date shall occur during either a regularly scheduled or special “blackout period” of the Company wherein Grantee is precluded from selling shares of the Company’s Stock, the receipt of the shares of Stock pursuant to this Agreement shall be deferred until immediately after the expiration of such blackout period, unless such shares are covered by a previously established Company-approved 10b5-1 plan of the Grantee, in which case the shares shall be issued in accordance with the terms of such 10b5-1 plan. The shares the receipt of which was deferred as provided above shall be issued to the Grantee as soon as practicable after the expiration of the blackout period. Notwithstanding the above, in no event may the shares be issued to the Grantee later than the later of: (i) December 31st of the calendar year in which the Delivery Date occurs, or (ii) the 75 th day following the Delivery Date; provided that the Grantee acknowledges and agrees that if the shares are issued to the Grantee pursuant to this sentence while either a regularly scheduled or special “blackout period” is still in effect with respect to the Company or the Grantee, neither the Company nor the Grantee may sell any shares of the Company’s Stock to satisfy any tax obligations except in compliance with the Company’s insider trading policies and requirements and applicable laws; provided further, that the Grantee acknowledges that the exact date of issuance of the shares shall be at the sole and exclusive discretion of the Company in accordance with this Section 4. The form of such issuance ( e.g. , a stock certificate or electronic entry evidencing such shares) shall be determined by the Company. Upon such issuance, the Grantee shall thereafter have all the rights of a stockholder of the Company with respect to such shares.

5. Incorporation of Plan . Notwithstanding anything herein to the contrary, this Agreement shall be subject to and governed by all the terms and conditions of the Plan, including

the powers of the Administrator set forth in Section 2(b) of the Plan. Capitalized terms in this Agreement shall have the meaning specified in the Plan, unless a different meaning is specified herein.

6. Section 409A of the Code. The parties intend that this Award will be administered in accordance with Section 409A of the Code. To the extent that any provision of this Award is ambiguous as to its compliance with Section 409A of the Code, the provision shall be read in such a manner so that all payments and provisions hereunder comply with Section 409A of the Code. Anything in this Agreement to the contrary notwithstanding, if at the time of the Grantee’s separation from service within the meaning of Section 409A of the Code, the Company determines that the Grantee is a “specified employee” within the meaning of Section 409A(a)(2)(B)(i) of the Code, then to the extent the shares of Stock that the Grantee becomes entitled to receive under this Agreement on account of the Grantee’s separation from service would be considered deferred compensation otherwise subject to the 20 percent additional tax imposed pursuant to Section 409A(a) of the Code as a result of the application of Section 409A(a)(2)(B)(i) of the Code, such shares of Stock shall not be issued until the date that is the earlier of (a) six months and one day after the Grantee’s separation from service, or (b) the Grantee’s death. The determination of whether and when a separation from service has occurred shall be made in accordance with the presumptions set forth in Treasury Regulation Section 1.409A-1(h).

7. No Obligation to Continue Service . Neither the Plan nor this Award confers upon the Grantee any rights with respect to continued service as a member of the Board or to the Company.

8. Integration . This Agreement constitutes the entire agreement between the parties with respect to this Award and supersedes all prior agreements and discussions between the parties concerning such subject matter.

9. Data Privacy Consent . In order to administer the Plan and this Agreement and to implement or structure future equity grants, the Company, its subsidiaries and affiliates and certain agents thereof (together, the “Relevant Companies”) may process any and all personal or professional data, including but not limited to Social Security or other identification number, home address and telephone number, date of birth and other information that is necessary or desirable for the administration of the Plan and/or this Agreement (the “Relevant Information”). By entering into this Agreement, the Grantee (i) authorizes the Company to collect, process, register and transfer to the Relevant Companies all Relevant Information; (ii) waives any privacy rights the Grantee may have with respect to the Relevant Information; (iii) authorizes the Relevant Companies to store and transmit such information in electronic form; and (iv) authorizes the transfer of the Relevant Information to any jurisdiction in which the Relevant Companies consider appropriate. The Grantee shall have access to, and the right to change, the Relevant Information. Relevant Information will only be used in accordance with applicable law.

10. Notices . Notices hereunder shall be mailed or delivered to the Company at its principal place of business to the attention of the Treasurer of the Company and shall be mailed or delivered to the Grantee at the address on file with the Company or, in either case, at such other address as one party may subsequently furnish to the other party in writing.

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AMAG PHARMACEUTICALS, INC.


By:
	Name:	William K. Heiden
	Title:	President and CEO

The foregoing Agreement is hereby accepted and the terms and conditions thereof hereby agreed to by the undersigned, and the undersigned acknowledges receipt of a copy of this entire Agreement, a copy of the Plan, and a copy of the Plan’s related prospectus. Electronic acceptance of this Agreement pursuant to the Company’s instructions to the Grantee (including through an online acceptance process) is acceptable.

Dated:	, 2013
		Grantee’s Signature


		Grantee’s name and address:

Exhibit 10.12

EMPLOYMENT AGREEMENT

This Employment Agreement (the “ Agreement ”) is entered into as of June 20, 2013 (the “ Effective Date ”) by and between (i) AMAG Pharmaceuticals, Inc., a Delaware corporation with offices at 100 Hayden Avenue, Lexington, MA 02421 (together with its subsidiaries and affiliates, the “ Company ”), and (ii) Steven Caffe, M.D., an individual residing at [address] (“ you ”).

Now therefore, in consideration of the premises and mutual agreements hereinafter set forth, and intending to be legally bound hereby, the parties hereto agree as follows:

1. Start Date ; Position; Duties .

a) Start Date . Your first day of employment with the Company shall be June 20, 2013 unless another date is agreed to in writing by the Company. For purposes of this Agreement, the actual first day of your employment shall be the “ Start Date ”. Your employment is contingent on (i) your submission of satisfactory proof of your identity and your legal authorization to work in the United States of America, (ii) satisfactory background and reference checks on you conducted after you provide authorization for such checks, (iii) your execution of the Company’s then current form of Non-Disclosure, Non-Competition, Non-Solicitation and Invention Assignment Agreement, (iv) your completion of federal and state tax withholding forms, (v) your certification that you have read and understood the Company’s Employee Handbook and certain of the Company’s corporate policies, and (vi) your certification that you have not been debarred or otherwise banned by any federal or state governmental agency, including, but not limited to, the Office of Inspector General of the U.S. Health and Human Services. All payments and benefits pursuant to this Agreement are contingent on you commencing employment with the Company.

b) Position; Duties . You shall perform for the Company the duties customarily associated with the office of Senior Vice President and Chief Development & Regulatory Officer and such other duties as may be assigned to you from time to time by the Company’s Chief Executive Officer or the Company’s Board of Directors (the “ Board ”) that are consistent with the duties normally performed by those performing the role of the most senior executives of similar entities. You shall devote substantially your full business time and best efforts to the performance of your duties hereunder and the business and affairs of the Company and will not undertake or engage in any other employment, occupation or business enterprise; provided, however, that you may participate as a member of the board of directors or advisory board of other entities and in professional organizations and civic and charitable organizations; provided further, that any such positions are disclosed to and approved in writing by the Chief Executive Officer and/or the Board or the Audit Committee thereof and do not materially interfere with your duties and responsibilities to the Company. Your office shall be based in the Company’s principal offices, which currently are in Lexington, Massachusetts.

2. Term . The term of this Agreement shall be for a three (3) year period commencing on the Effective Date unless terminated earlier pursuant to Section 4 below (the “ Initial Term ”). The term of this Agreement shall automatically renew for additional three-year terms (each, a “ Renewal Term ”) following the Initial Term and any Renewal Term unless either party provides written notice to the other party at least sixty (60) days before the end of the Initial Term or any Renewal Term, as applicable, that it does not desire to renew this Agreement, in which case this Agreement shall expire at the end of the Initial Term or any Renewal Term, as applicable. The Initial Term and any Renewal Term are referred to herein collectively as the “ Term .”

3. Compensation and Benefits . The Company shall pay you the following compensation and benefits for all services rendered by you under this Agreement:

a) Base Salary . The Company will pay you a base salary at the annualized rate of $375,000 (“ Base Salary ”), minus withholdings as required by law and other deductions authorized by you, which amount shall be paid in equal installments at the Company’s regular payroll intervals, but not less often than monthly. Your base salary may be increased annually by the Board or the Compensation Committee in their sole discretion.

b) Annual Performance Bonus . You will be eligible to receive an annual performance bonus (the “ Annual Bonus ”) of up to 40% of Base Salary for each fiscal year during the Term of this Agreement beginning with the fiscal year ending December 31, 2013 based on the extent to which, in the discretion of the Board or the Compensation Committee in consultation with the Chief Executive Officer and/or your supervisor you achieve or exceed specific and measurable individual and Company performance objectives established by the Board or the Compensation Committee in consultation with the Chief Executive Officer and/or your supervisor and communicated to you in advance. Notwithstanding the foregoing, your bonus opportunity with respect to the 2013 fiscal year shall be pro-rated based on the Start Date and length of your employment during such fiscal year. The exact amount of the bonus for any year during the Term shall be determined by the Board or the Compensation Committee in its sole discretion and may be more than the target bonus in the event you achieve all of your personal and Company performance objectives or less than the target bonus if you do not achieve all of your personal and Company performance objectives. The Company shall pay the Annual Bonus no later than two and a half months after the end of the fiscal year to which the applicable bonus relates. Unless otherwise provided herein, no bonus shall be deemed to have been earned by you for any year in which you are not actively employed by the Company on the last day of the fiscal year to which the bonus relates.

1986, as amended (the “ Code ”). These equity incentive grants shall vest in equal annual installments over a four year period commencing on the Start Date. You shall be eligible to receive stock options or other equity compensation in the future under the Company’s equity incentive plans as determined by the Board or the Compensation Committee from time to time.

d) Vacation . You will receive four (4) weeks of paid vacation per calendar year which shall accrue ratably on a monthly basis, and this accrual will be pro-rated in the first year of employment.

e) Benefits . You will be eligible to participate in all group health, dental, 401(k), and other insurance and/or benefit plans that the Company may offer to similarly situated executives of the Company from time to time on the same terms as offered to such other executives.

f) Business Expenses . The Company will reimburse you for all reasonable and usual business expenses incurred by you in the performance of your duties hereunder in accordance with the Company’s expense reimbursement policy.

g) Moving Expenses . You will relocate your domicile to the Boston area within ninety (90) days of the Start Date. In connection therewith, the Company will also provide you with relocation assistance as described in the attached document entitled “AMAG Pharmaceuticals Relocation Policy Tier 1” and marked as Exhibit A to this Agreement. MoveTrek Mobility will be your single point of coordination for all relocation related services. In order to be eligible for reimbursement within the relocation allowance/program outlined, you must work through MoveTrek Mobility. Please do not contact any real estate agents or van lines before speaking with MoveTrek. The lump sum payments described in the policy will be paid on the next payroll date following your Start Date. All of the described relocation amounts must be incurred by you within 12 months of your Start Date or they will not be eligible for payment or reimbursement. If you voluntarily terminate your employment with the Company prior to the first anniversary of your Start Date, you shall reimburse the Company 100% of all relocation assistance payments and reimbursements. If you voluntarily terminate your employment with the Company after the first but prior to the second anniversary of your Start Date, you shall reimburse the company 50% of these amounts.

4. Termination . Your employment with the Company may be terminated prior to the expiration of the Term as follows:

a) Death . This Agreement shall terminate automatically upon your death.

b) Disability . The Company may terminate your employment in accordance with applicable laws in the event that you shall be prevented, by illness, accident, disability or any other physical or mental condition (to be determined by means of a written opinion of a competent medical doctor chosen by mutual agreement of the Company and you or your personal representative(s)) from substantially performing your duties and responsibilities hereunder for one or more periods totaling one hundred and twenty (120) days in any twelve (12) month period.

c) By the Company for Cause . The Company may terminate your employment for “Cause” upon written notice to you. For purposes of this Agreement, “ Cause ” shall mean any of: (i) fraud, embezzlement or theft against the Company or any of its affiliates; (ii) you are convicted of, or plead guilty or no contest to, a felony; (iii) willful nonperformance by you (other than by reason of illness) of your material duties hereunder and failure to remedy such nonperformance within ten (10) business days following written notice from the Chief Executive Officer, the Board and/or your supervisor identifying the nonperformance and the actions required to cure it; or (iv) you commit an act of gross negligence, engage in willful misconduct or otherwise act with willful disregard for the Company’s best interests, and you fail to remedy such conduct within ten (10) business days following written notice from the Chief Executive Officer, the Board and/or your supervisor identifying the gross negligence, willful misconduct or willful disregard and the actions required to cure it (if such conduct can be cured).

d) By the Company Other Than For Death, Disability or Cause . The Company may terminate your employment other than for Cause, disability or death upon thirty (30) days prior written notice to you.

e) By You For Good Reason or Any Reason . You may terminate your employment at any time with or without Good Reason upon thirty (30) days prior written notice to the Company. For purposes of this Agreement, “ Good Reason ” shall mean that any of the following occurs without your prior written consent: (i) a material adverse change in your title, position, duties or responsibilities; (ii) a material reduction by the Company in your Base Salary or your target Annual Bonus opportunity in the total annual amount that you are then eligible to receive, unless such reduction is in connection with a proportionate reduction of compensation applicable to all other executive officers; (iii) any relocation of your principal place of business to a location more than 50 miles from the Company’s current executive offices in Lexington, MA; or (iv) a material breach by the Company of any of the terms or provisions of this Agreement and failure to remedy such breach within thirty (30) days following written notice from you identifying the breach.

5. Payment Upon Termination . In the event that your employment with the Company terminates, you will be paid the following:

a) Termination for Any Reason. In the event that your employment terminates for any reason, the Company shall pay you for the following items that were earned and accrued but unpaid as of the date of your termination: (i) your Base Salary; (ii) a cash payment for all accrued, unused vacation calculated at your then Base Salary rate; (iii) reimbursement for any unpaid business expenses; and (iv) such other benefits and payments to which you may be entitled by law or pursuant to the benefit plans of the Company then in effect. In addition, if your employment terminates due to your death, the Board or the Compensation Committee, in consultation with the Chief Executive Officer and/or your supervisor, shall determine the extent to which any of the individual performance objectives established pursuant to Section 3(b) above were met as of the time of your death. If, based on that determination, the Board or the Compensation Committee determines that a bonus is due,

the Company shall pay your estate an amount equal to such bonus, pro-rated for the portion of the fiscal year elapsed as of the time of your death.

b) Termination Without Cause or for Good Reason . In addition to the payments provided for in Section 5(a), in the event that (i) the Company terminates your employment other than for death, disability or Cause pursuant to Section 4(d) or you terminate your employment for Good Reason pursuant to Section 4(e); (ii) you comply fully with all of your obligations under all agreements between the Company and you; and (iii) you execute, deliver to the Company, within 60 days of the termination of your employment, and do not revoke a general release (in a form acceptable to the Company) releasing and waiving any and all claims that you have or may have against the Company, its directors, officers, employees, agents, successors and assigns with respect to your employment (other than any obligation of the Company set forth herein which specifically survives the termination of your employment), then the Company will provide you with twelve (12) months of severance pay based on your then current Base Salary. The foregoing severance shall be paid in equal installments over the severance period in accordance with the Company’s usual payroll schedule, commencing on the date that the release referred to above may no longer be revoked. This Section 5(b) shall not apply during the one year period following a Change of Control (as defined below), in which case Section 5(c) shall apply. Notwithstanding anything to the contrary herein, if any of the payments and benefits provided for in this Section 5(b) constitute non-qualified deferred compensation subject to Section 409A and the sixty (60) day period in which you must execute the release begins in one calendar year and ends in another, the payments and benefits provided for in this Section 5(b) shall commence, be made or become effective in the later calendar year.

c) Change of Control . Upon a Change of Control, subject to the terms of any other agreements that exist between you and the Company, fifty percent (50%) of the unvested portion of any options to purchase common stock, restricted stock units and other equity incentives then held by you shall become immediately vested and the remaining unvested amount shall continue to vest after the closing of the Change of Control on the same vesting schedule but at 50% of the number of shares that were to vest on each vesting date prior to the Change of Control. Further, in the event that (i) within one year from the date a Change of Control (as defined below) of the Company occurs, the Company (for purposes of this Section, such term to include its successor) terminates your employment other than for Cause pursuant to Section 4(c), death or disability or you terminate your employment with Good Reason; (ii) you comply fully with all of your obligations under all agreements between the Company and you; and (iii) within 60 days of termination of your employment you execute and deliver to the Company and do not revoke a general release (in a form acceptable to the Company) releasing and waiving any and all claims that you have or may have against the Company and its directors, officers, employees, agents, successors and assigns with respect to your employment (other than any obligation of the Company set forth herein which specifically survives the termination of your employment), then:

· the Company will pay you twelve (12) months of severance pay based on your then current Base Salary, with such severance to be paid in equal installments over the severance period in accordance with the Company’s usual payroll

schedule, commencing on the date that the release referred to above may no longer be revoked;

· the Company will pay you, promptly after the revocation period of the release set forth above expires, in a lump sum, one times your target annual bonus amount for the year in which the Change of Control occurs;

· the Company will pay or reimburse you for the premiums for continued coverage for you and your eligible dependents in the same amounts and for the same coverage in effect immediately prior to your termination from employment, under the Company’s group health and dental plans until the earlier of: (i) twenty four (24) months from the date of termination of your employment; or (ii) the date you are provided with health and dental coverage by another employer’s health and dental plan (and, for purposes of clarity, if the Company is unable to extend coverage to you under its group health and dental plans due to your termination from active employment status, then, to receive this benefit, you must elect continuation coverage under COBRA and/or purchase an individual insurance policy, and the Company shall have no obligation to pay or reimburse insurance premiums or otherwise provide coverage if you fail to elect COBRA or obtain an individual policy); and

· all unvested outstanding stock options, restricted stock units and other equity incentives that were granted to you before the Change of Control occurred shall immediately without further action become vested in full.

For purposes of this Agreement, “ Change of Control ” shall mean the first to occur of any of the following: (a) any “person” or “group” (as defined in the Securities Exchange Act of 1934, as amended) becomes the beneficial owner of a majority of the combined voting power of the then outstanding voting securities with respect to the election of the Board of Directors of the Company; (b) any merger, consolidation or similar transaction involving the Company, other than a transaction in which the stockholders of the Company immediately prior to the transaction hold immediately thereafter in the same proportion as immediately prior to the transaction not less than 50% of the combined voting power of the then voting securities with respect to the election of the Board of Directors of the resulting entity; (c) any sale of all or substantially all of the assets of the Company; or (d) any other acquisition by a third party of all or substantially all of the business or assets of the Company, as determined by the Board of Directors, in its sole discretion. The payments, benefits and acceleration of vesting of stock options, restricted stock units and other equity incentives provided in this Section 5(c) shall override and replace with respect to you any Company wide policy with respect to payments, benefits and/or acceleration of vesting upon a Change of Control. After the one year period following a Change of Control, this Section 5(c) shall no longer apply, and Section 5(b) shall continue to apply. In the event that upon a Change of Control, the Company or the successor to or acquiror of the Company’s business (whether by sale of outstanding stock, merger, sale of substantially all the assets or otherwise) elects not to assume all the then unvested outstanding stock options, restricted stock units and other equity incentives that were granted to you before the Change of Control occurred, such securities shall immediately without further action become vested in full effective no later than the effective date of the Change of Control and you shall receive the value of such stock options, restricted stock units and other equity incentives as provided in the applicable acquisition agreement (or if no such provision is made, in the applicable equity incentive plan).

Notwithstanding anything to the contrary herein, if any of the payments and benefits provided for in this Section 5(c) constitute non-qualified deferred compensation subject to Section 409A and the sixty (60) day period in which you must execute the release begins in one calendar year and ends in another, the payments and benefits provided for in this Section 5(c) shall commence, be made or become effective in the later calendar year.

d) Death/Disability . In addition to the payments provided for in Section 5(a), in the event of your death or the termination of your employment due to your disability in accordance with Section 4(b) above, all unvested outstanding stock options, restricted stock units and other equity incentives that were held by you at the time of your death or termination of employment due to disability shall immediately become fully vested and exercisable by you or your personal representatives, heirs or legatees, as the case may be, at any time prior to the expiration of one (1) year from the date of your death or disability, but in no event after the expiration of the term of the applicable equity award agreement.

6. Nonsolicitation Covenant; Non-Competition; Injunctive Relief. In exchange for the consideration provided by this Agreement, you shall not, for a period of one year following the termination of your employment with the Company for any reason, directly or indirectly, whether through your own efforts, or in any way assisting or employing the assistance of any other person or entity (including, without limitation, any consultant or any person employed by or associated with any entity with which you are employed or associated), recruit, solicit or induce (or in any way assist another in recruiting, soliciting or inducing) any employee or consultant of the Company to terminate his or her employment or other relationship with the Company. In further exchange for the consideration provided by this Agreement, you shall not, for a period of one year following the termination of your employment with the Company for any reason, directly or indirectly, as an officer, director, employee, consultant, owner, partner, or in any other capacity solicit, perform, or provide, or attempt to perform or provide any services to any person or entity with respect to a Competing Product, nor will you assist another person or entity to solicit, perform or provide or attempt to perform or provide services with respect to a Competing Product. For purposes of this Agreement, “ Competing Product ” shall mean (i) an intravenous iron replacement therapeutic, (ii) a mucoadhesive oral wound rinse or other device is indicated for the management of oral mucositis/stomatitis, or (iii) other therapeutic products acquired, developed or researched by the Company during the Term. You agree that these restrictions are reasonable and have been specifically agreed upon based on the consideration set forth in this Agreement. Any breach of this Agreement is likely to cause the Company substantial and irrevocable damage and therefore, in the event of such breach, the Company, in addition to such other remedies which may be available, will be entitled to specific performance and other injunctive relief, without the posting of a bond.

7. Assignment . This Agreement and the rights and obligations of the parties hereto shall bind and inure to the benefit of any successor of the Company by reorganization, merger or consolidation and any assignee of all or substantially all of its business and properties. Neither this Agreement nor any rights or benefits hereunder may be assigned by you, except that, upon your death, your earned and unpaid economic benefits will be paid to your heirs or beneficiaries.

8. Interpretation and Severability . It is the express intent of the parties that (a) in case any one or more of the provisions contained in this Agreement shall for any reason be held to be excessively broad as to duration, geographical scope, activity or subject, such provision shall be construed by limiting and reducing it as determined by a court of competent jurisdiction, so as to be enforceable to the fullest extent compatible with applicable law; and (b) in case any one or more of the provisions contained in this Agreement cannot be so limited and reduced and for any reason is held to be invalid, illegal or unenforceable, such invalidity, illegality or unenforceability shall not affect the other provisions of this Agreement, and this Agreement shall be construed as if such invalid, illegal or unenforceable provision had never been contained herein.

9. Notices . Any notice that you or the Company are required to give the other under this Agreement shall be given by personal delivery, recognized overnight courier service, or registered or certified mail, return receipt requested, addressed in your case to you at your last address of record with the Company, or at such other place as you may from time to time designate in writing, and, in the case of the Company, to the Company at its principal office to the attention of the President and Chief Executive Officer, or at such other office as the Company may from time to time designate in writing. The date of actual delivery of any notice under this Section 9 shall be deemed to be the date of receipt thereof.

10. Waiver . No consent to or waiver of any breach or default in the performance of any obligation hereunder shall be deemed or construed to be a consent to or waiver of any other breach or default in the performance of any of the same or any other obligations hereunder. No waiver hereunder shall be effective unless it is in writing and signed by the waiving party.

11. Complete Agreement; Modification; Acknowledgement . This Agreement sets forth the entire agreement of the parties with respect to the subject matter hereof, and supersedes any previous oral or written communications, negotiations, representations, understandings, or agreements between them, including, without limitation, your Employment Offer Letter dated March 27, 2013. Any modification of this Agreement shall be effective only if set forth in a written document signed by you and a duly authorized officer of the Company.

12. Headings . The headings of the Sections hereof are inserted for convenience only and shall not be deemed to constitute a part, or affect the meaning, of this Agreement.

13. Counterparts . This Agreement may be signed in two (2) counterparts, each of which shall be deemed an original and both of which shall together constitute one agreement.

14. Choice of Law; Jurisdiction . This Agreement shall be deemed to have been made in the Commonwealth of Massachusetts, and the validity, interpretation and performance of this Agreement shall be governed by, and construed in accordance with, the laws of Massachusetts, without regard to conflict of law principles. You hereby consent and submit without limitation to the jurisdiction of courts in Massachusetts in connection with any action arising out of this Agreement, and waive any right to object to any such forum as inconvenient or to object to venue in Massachusetts. You agree that, in any action arising out of this Agreement, you will accept service of process by registered mail or the equivalent directed to your last known address or by such other means permitted by such court.

15. Advice of Counsel; No Representations . You acknowledge that you have been advised to review this Agreement with your own legal counsel, that prior to entering into this Agreement, you have had the opportunity to review this Agreement with your attorney, and that the Company has not made any representations, warranties, promises or inducements to you concerning the terms, enforceability or implications of this Agreement other than as are contained in this Agreement.

16. I.R.C. § 409A . Notwithstanding anything to the contrary set forth herein, any payments and benefits provided under this Agreement that constitute “deferred compensation” within the meaning of Section 409A of the Code and the regulations and other guidance thereunder and any state law of similar effect (collectively, the “ Section 409A ”) shall not commence in connection with your termination of employment unless and until you have also incurred a “separation from service” (as such term is defined in Treasury Regulation Section 1.409A-1(h) (the “ Separation From Service ”), unless the Company reasonably determines that such amounts may be provided to you without causing you to incur the additional 20% tax under Section 409A.

It is intended that each installment of severance pay provided for in this Agreement is a separate “payment” for purposes of Treasury Regulation Section 1.409A-2(b)(2)(i). For the avoidance of doubt, it is intended that severance payments set forth in this Agreement satisfy, to the greatest extent possible, the exceptions from the application of Section 409A provided under Treasury Regulation Sections 1.409A-1(b)(4), 1.409A-1(b)(5), and 1.409A-1(b)(9).

If the Company (or, if applicable, the successor entity thereto) determines that any payments or benefits constitute “deferred compensation” under Section 409A and you are, on the termination of service, a “specified employee” of the Company or any successor entity thereto, as such term is defined in Section 409A(a)(2)(B)(i) of the Code, then, solely to the extent necessary to avoid the incurrence of the adverse personal tax consequences under Section 409A, the timing of the payments and benefits shall be delayed until the earlier to occur of: (a) the date that is six months and one day after your Separation From Service, or (b) the date of your death (such applicable date, the “ Specified Employee Initial Payment Date ”). On the Specified Employee Initial Payment Date, the Company (or the successor entity thereto, as applicable) shall (i) pay to you a lump sum amount equal to the sum of the payments and benefits that you would otherwise have received through the Specified Employee Initial Payment Date if the commencement of the payment of such amounts had not been so delayed pursuant to this Section and (ii) commence paying the balance of the payments and benefits in accordance with the applicable payment schedules set forth in this Agreement.

17. Survival . Provisions of this Agreement which by their terms must survive the termination of this Agreement in order to effectuate the intent of the parties will survive any such termination, whether by expiration of the Term, termination of your employment, or otherwise, for such period as may be appropriate under the circumstances. Such provisions include, without limitation, Sections 5 and 6 of this Agreement.

then such Payment shall be adjusted so that it would equal the Reduced Amount. The “Reduced Amount” shall be either (i) the largest portion of the Payment that would result in no portion of the Payment being subject to the Excise Tax or (ii) the total Payment, whichever amount of (i) or (ii), after taking into account all applicable federal, state and local employment taxes, income taxes, and the Excise Tax (all computed at the highest applicable marginal rate), results in your receipt, on an after-tax basis, of the greater amount of the Payment notwithstanding that all or some portion of the Payment may be subject to the Excise Tax. If a reduction in payments or benefits constituting “parachute payments” is necessary so that the Payment equals the Reduced Amount, any such reduction will occur in a manner necessary to provide you with the greatest post-reduction economic benefit. If more than one manner of reduction of Payments necessary to arrive at the Reduced Amount yields the greatest economic benefit to you, the Payments will be reduced pro rata.

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SIGNATURE PAGE TO EMPLOYMENT AGREEMENT

IN WITNESS WHEREOF , the Company and you have executed this Agreement as of the Effective Date.

	AMAG PHARMACEUTICALS, INC.


	By:	/s/ William K. Heiden
	Name:	William K. Heiden
	Title:	President and CEO


	/s/ Steve Caffe
	Steven Caffe, M.D

Exhibit 10.13

EMPLOYMENT AGREEMENT

This Employment Agreement (the “ Agreement ”) is entered into as of July 22, 2013 (the “ Effective Date ”) by and between (i) AMAG Pharmaceuticals, Inc., a Delaware corporation with offices at 100 Hayden Avenue, Lexington, MA 02421 (together with its subsidiaries and affiliates, the “ Company ”), and (ii) Carol Ann Satler, M.D., Ph.D., an individual residing at [address] (“ you ”).

Now therefore, in consideration of the premises and mutual agreements hereinafter set forth, and intending to be legally bound hereby, the parties hereto agree as follows:

1. Start Date ; Position; Duties .

a) Start Date . Your first day of employment with the Company shall be July 22, 2013 unless another date is agreed to in writing by the Company. For purposes of this Agreement, the actual first day of your employment shall be the “ Start Date ”. Your employment is contingent on (i) your submission of satisfactory proof of your identity and your legal authorization to work in the United States of America, (ii) satisfactory background and reference checks on you conducted after you provide authorization for such checks, (iii) your execution of the Company’s then current form of Non-Disclosure, Non-Competition, Non-Solicitation and Invention Assignment Agreement, (iv) your completion of federal and state tax withholding forms, (v) your certification that you have read and understood the Company’s Employee Handbook and certain of the Company’s corporate policies, and (vi) your certification that you have not been debarred or otherwise banned by any federal or state governmental agency, including, but not limited to, the Office of Inspector General of the U.S. Health and Human Services. All payments and benefits pursuant to this Agreement are contingent on you commencing employment with the Company.

b) Position; Duties . You shall perform for the Company the duties customarily associated with the office of Senior Vice President of Medical and Scientific Affairs and such other duties as may be assigned to you from time to time by the Company’s Chief Executive Officer or the Company’s Board of Directors (the “ Board ”) that are consistent with the duties normally performed by those performing the role of the most senior executives of similar entities. You shall devote substantially your full business time and best efforts to the performance of your duties hereunder and the business and affairs of the Company and will not undertake or engage in any other employment, occupation or business enterprise; provided, however, that you may participate as a member of the board of directors or advisory board of other entities and in professional organizations and civic and charitable organizations; provided further, that any such positions are disclosed to and approved in writing by the Chief Executive Officer and/or the Board or the Audit Committee thereof and do not materially interfere with your duties and responsibilities to the Company. Your office shall be based in the Company’s principal offices, which currently are in Lexington, Massachusetts.

terms (each, a “ Renewal Term ”) following the Initial Term and any Renewal Term unless either party provides written notice to the other party at least sixty (60) days before the end of the Initial Term or any Renewal Term, as applicable, that it does not desire to renew this Agreement, in which case this Agreement shall expire at the end of the Initial Term or any Renewal Term, as applicable. The Initial Term and any Renewal Term are referred to herein collectively as the “ Term .”

3. Compensation and Benefits . The Company shall pay you the following compensation and benefits for all services rendered by you under this Agreement:

a) Base Salary . The Company will pay you a base salary at the annualized rate of $340,000 (“ Base Salary ”), minus withholdings as required by law and other deductions authorized by you, which amount shall be paid in equal installments at the Company’s regular payroll intervals, but not less often than monthly. Your base salary may be increased annually by the Board or the Compensation Committee in their sole discretion.

b. Annual Performance Bonus . You will be eligible to receive an annual performance bonus (the “ Annual Bonus ”) of up to 40% of Base Salary for each fiscal year during the Term of this Agreement beginning with the fiscal year ending December 31, 2013 based on the extent to which, in the discretion of the Board or the Compensation Committee in consultation with the Chief Executive Officer and/or your supervisor you achieve or exceed specific and measurable individual and Company performance objectives established by the Board or the Compensation Committee in consultation with the Chief Executive Officer and/or your supervisor and communicated to you in advance. Notwithstanding the foregoing, your bonus opportunity with respect to the 2013 fiscal year shall be pro-rated based on the Start Date and length of your employment during such fiscal year. The exact amount of the bonus for any year during the Term shall be determined by the Board or the Compensation Committee in its sole discretion and may be more than the target bonus in the event you achieve all of your personal and Company performance objectives or less than the target bonus if you do not achieve all of your personal and Company performance objectives. The Company shall pay the Annual Bonus no later than two and a half months after the end of the fiscal year to which the applicable bonus relates. Unless otherwise provided herein, no bonus shall be deemed to have been earned by you for any year in which you are not actively employed by the Company on the last day of the fiscal year to which the bonus relates.

c) Equity Compensation . Promptly after the first day of your employment with the Company, subject to approval by the Compensation Committee of the Company’s Board (the “ Compensation Committee ”), you shall be granted (i) an option with respect to 45,000 shares of Common Stock of the Company with an exercise price equal to the then fair market value of the Common Stock, and (ii) restricted stock units with respect to 15,000 shares of Common Stock. The foregoing equity incentive awards shall be granted pursuant to the inducement grant exception set forth in NASDAQ Listing Rule 5635(c)(4). Such equity incentive awards will not be issued under Section 422 of the Internal Revenue Code of 1986, as amended (the “ Code ”). These equity incentive grants shall vest in equal annual installments over a four year period commencing on the Start Date. You shall be eligible to receive stock options or other equity compensation in the future under the Company’s equity incentive plans as determined by the Board or the Compensation Committee from time to time.

d) Vacation . You will receive four (4) weeks of paid vacation per calendar year which shall accrue ratably on a monthly basis, and this accrual will be pro-rated in the first year of employment.

4. Termination . Your employment with the Company may be terminated prior to the expiration of the Term as follows:

a) Death . This Agreement shall terminate automatically upon your death.

d) By the Company Other Than For Death, Disability or Cause . The Company may terminate your employment other than for Cause, disability or death upon thirty (30) days prior written notice to you.

following occurs without your prior written consent: (i) a material adverse change in your title, position, duties or responsibilities; (ii) a material reduction by the Company in your Base Salary or your target Annual Bonus opportunity in the total annual amount that you are then eligible to receive, unless such reduction is in connection with a proportionate reduction of compensation applicable to all other executive officers; (iii) any relocation of your principal place of business to a location more than 50 miles from the Company’s current executive offices in Lexington, MA; or (iv) a material breach by the Company of any of the terms or provisions of this Agreement and failure to remedy such breach within thirty (30) days following written notice from you identifying the breach.

5. Payment Upon Termination . In the event that your employment with the Company terminates, you will be paid the following:

outstanding voting securities with respect to the election of the Board of Directors of the Company; (b) any merger, consolidation or similar transaction involving the Company, other than a transaction in which the stockholders of the Company immediately prior to the transaction hold immediately thereafter in the same proportion as immediately prior to the transaction not less than 50% of the combined voting power of the then voting securities with respect to the election of the Board of Directors of the resulting entity; (c) any sale of all or substantially all of the assets of the Company; or (d) any other acquisition by a third party of all or substantially all of the business or assets of the Company, as determined by the Board of Directors, in its sole discretion. The payments, benefits and acceleration of vesting of stock options, restricted stock units and other equity incentives provided in this Section 5(c) shall override and replace with respect to you any Company wide policy with respect to payments, benefits and/or acceleration of vesting upon a Change of Control. After the one year period following a Change of Control, this Section 5(c) shall no longer apply, and Section 5(b) shall continue to apply. In the event that upon a Change of Control, the Company or the successor to or acquiror of the Company’s business (whether by sale of outstanding stock, merger, sale of substantially all the assets or otherwise) elects not to assume all the then unvested outstanding stock options, restricted stock units and other equity incentives that were granted to you before the Change of Control occurred, such securities shall immediately without further action become vested in full effective no later than the effective date of the Change of Control and you shall receive the value of such stock options, restricted stock units and other equity incentives as provided in the applicable acquisition agreement (or if no such provision is made, in the applicable equity incentive plan).

any reason, directly or indirectly, as an officer, director, employee, consultant, owner, partner, or in any other capacity solicit, perform, or provide, or attempt to perform or provide any services to any person or entity with respect to a Competing Product, nor will you assist another person or entity to solicit, perform or provide or attempt to perform or provide services with respect to a Competing Product. For purposes of this Agreement, “ Competing Product ” shall mean (i) an intravenous iron replacement therapeutic, (ii) a mucoadhesive oral wound rinse or other device is indicated for the management of oral mucositis/stomatitis, or (iii) other therapeutic products acquired, developed or researched by the Company during the Term. You agree that these restrictions are reasonable and have been specifically agreed upon based on the consideration set forth in this Agreement. Any breach of this Agreement is likely to cause the Company substantial and irrevocable damage and therefore, in the event of such breach, the Company, in addition to such other remedies which may be available, will be entitled to specific performance and other injunctive relief, without the posting of a bond.

11. Complete Agreement; Modification; Acknowledgement . This Agreement sets forth the entire agreement of the parties with respect to the subject matter hereof, and supersedes

any previous oral or written communications, negotiations, representations, understandings, or agreements between them. Any modification of this Agreement shall be effective only if set forth in a written document signed by you and a duly authorized officer of the Company.

12. Headings . The headings of the Sections hereof are inserted for convenience only and shall not be deemed to constitute a part, or affect the meaning, of this Agreement.

13. Counterparts . This Agreement may be signed in two (2) counterparts, each of which shall be deemed an original and both of which shall together constitute one agreement.

necessary to avoid the incurrence of the adverse personal tax consequences under Section 409A, the timing of the payments and benefits shall be delayed until the earlier to occur of: (a) the date that is six months and one day after your Separation From Service, or (b) the date of your death (such applicable date, the “ Specified Employee Initial Payment Date ”). On the Specified Employee Initial Payment Date, the Company (or the successor entity thereto, as applicable) shall (i) pay to you a lump sum amount equal to the sum of the payments and benefits that you would otherwise have received through the Specified Employee Initial Payment Date if the commencement of the payment of such amounts had not been so delayed pursuant to this Section and (ii) commence paying the balance of the payments and benefits in accordance with the applicable payment schedules set forth in this Agreement.

18. Excise Tax-Related Provisions . If any payment or benefit you would receive pursuant to this Agreement or any other agreement (“ Payment ”) would (a) constitute a “parachute payment” within the meaning of Section 280G of the Code, and (b) but for this sentence, be subject to the excise tax imposed by Section 4999 of the Code (the “ Excise Tax ”), then such Payment shall be adjusted so that it would equal the Reduced Amount. The “Reduced Amount” shall be either (i) the largest portion of the Payment that would result in no portion of the Payment being subject to the Excise Tax or (ii) the total Payment, whichever amount of (i) or (ii), after taking into account all applicable federal, state and local employment taxes, income taxes, and the Excise Tax (all computed at the highest applicable marginal rate), results in your receipt, on an after-tax basis, of the greater amount of the Payment notwithstanding that all or some portion of the Payment may be subject to the Excise Tax. If a reduction in payments or benefits constituting “parachute payments” is necessary so that the Payment equals the Reduced Amount, any such reduction will occur in a manner necessary to provide you with the greatest post-reduction economic benefit. If more than one manner of reduction of Payments necessary to arrive at the Reduced Amount yields the greatest economic benefit to you, the Payments will be reduced pro rata.

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SIGNATURE PAGE TO EMPLOYMENT AGREEMENT

IN WITNESS WHEREOF , the Company and you have executed this Agreement as of the Effective Date.

AMAG PHARMACEUTICALS, INC.

By:	/s/ William K. Heiden
Name:	William K. Heiden
Title:	President and CEO


/s/ Carol Ann Satler
Carol Ann Satler, M.D., Ph.D.

Exhibit 31.1

CERTIFICATIONS

I, William K. Heiden, 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(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 7, 2013

	/s/ William K. Heiden
	William K. Heiden
	President and Chief Executive Officer (Principal Executive Officer)

Exhibit 31.2

CERTIFICATIONS

I, Scott A. Holmes, certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of AMAG Pharmaceuticals, Inc.;

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: August 7, 2013

	/s/ Scott A. Holmes
	Scott A. Holmes
	Chief Accounting Officer, Vice President of Finance and Treasurer
	(Principal Financial 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. (the “Company”) on Form 10-Q for the period ended June 30, 2013 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, William K. Heiden, President and Chief Executive 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 the best of 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/ William K. Heiden
	William K. Heiden
	President and Chief Executive Officer
	(principal executive officer)

August 7, 2013

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. (the “Company”) on Form 10-Q for the period ended June 30, 2013 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Scott A. Holmes, Chief Accounting Officer, Vice President of Finance and Treasurer 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 the best of 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/ Scott A. Holmes
	Scott A. Holmes
	Chief Accounting Officer, Vice President of Finance and Treasurer
	(principal financial officer)


August 7, 2013