10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

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

For the quarterly period ended September 30, 2020

or
☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from                        to

Commission file number 001-10865

AMAG Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Its Charter)

Delaware			04-2742593
(State or Other Jurisdiction of Incorporation or Organization)			(I.R.S. Employer Identification No.)
1100 Winter Street,	Waltham,	Massachusetts	02451
(Address of Principal Executive Offices)			(Zip Code)

(617) 498-3300

(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.01 per share	AMAG	NASDAQ Global Select Market

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 ☒  No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒  No ☐

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

Large accelerated filer	☐	Accelerated filer	☒
Non-accelerated filer	☐	Smaller reporting company	☐
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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

As of November 4, 2020, there were 34,725,063 shares of the registrant’s Common Stock, par value $0.01 per share, outstanding.

AMAG PHARMACEUTICALS, INC.

FORM 10-Q

FOR THE QUARTER ENDED SEPTEMBER 30, 2020

TABLE OF CONTENTS

PART I.	FINANCIAL INFORMATION (Unaudited)	3
Item 1.	Financial Statements	3
	Condensed Consolidated Balance Sheets as of September 30, 2020 and December 31, 2019	4
	Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2020 and 2019	5
	Condensed Consolidated Statements of Comprehensive Income (Loss) for the Three and Nine Months Ended September 30, 2020 and 2019	6
	Condensed Consolidated Statements of Stockholders’ Equity for the Three and Nine Months ended September 30, 2020 and 2019	7
	Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2020 and 2019	9
	Notes to Condensed Consolidated Financial Statements	10
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	31
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	44
Item 4.	Controls and Procedures	44
PART II.	OTHER INFORMATION	44
Item 1.	Legal Proceedings	45
Item 1A.	Risk Factors	45
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	52
Item 5.	Other Information	53
Item 6.	Exhibits	54
Signatures		55

2

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements:

3

AMAG PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA)

(Unaudited)

	September 30, 2020		December 31, 2019
ASSETS
Current assets:
Cash and cash equivalents	$	97,984	$	113,009
Marketable securities	70,917		58,742
Accounts receivable, net	67,608		94,163
Inventories	22,906		31,553
Prepaid and other current assets	23,959		19,100
Total current assets	283,374		316,567
Property and equipment, net	2,415		4,116
Goodwill	422,513		422,513
Intangible assets, net	1,973		23,620
Operating lease right-of-use asset	21,063		23,286
Deferred tax assets	—		630
Restricted cash	495		495
Other long-term assets	2,523		—
Total assets	$	734,356	$	791,227
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	9,742	$	27,021
Accrued expenses	146,597		183,382
Current portion of deferred revenue	2,477		—
Current portion of operating lease liability	3,161		4,077
Current portion of acquisition-related contingent consideration	—		17
Total current liabilities	161,977		214,497
Long-term liabilities:
Convertible notes, net	289,334		277,034
Long-term operating lease liability	18,726		19,791
Long-term deferred revenue	7,662		—
Other long-term liabilities	635		89
Total liabilities	478,334		511,411
Commitments and contingencies (Note 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, 117,500,000 shares authorized; 34,503,435 and 33,999,081 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively	345		339
Additional paid-in capital	1,305,412		1,297,917
Accumulated other comprehensive loss	(3,068)		(3,239)
Accumulated deficit	(1,046,667)		(1,015,201)
Total stockholders’ equity	256,022		279,816
Total liabilities and stockholders’ equity	$	734,356	$	791,227

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

4

AMAG PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(IN THOUSANDS, EXCEPT PER SHARE DATA)

(Unaudited)

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Revenues:
Product sales, net	$	73,229	$	83,784	$	190,702	$	236,831
Collaboration revenue	19,838		—		19,838		—
Other revenues	39		24		97		231
Total revenues	93,106		83,808		210,637		237,062
Costs and expenses:
Cost of product sales	13,340		21,105		55,426		63,871
Research and development expenses	7,115		15,330		26,558		48,377
Acquired in-process research and development	—		—		—		74,856
Selling, general and administrative expenses	35,656		65,720		127,922		217,727
Impairment of intangible assets	—		—		—		77,358
Loss on disposal of assets, net	35,400		—		20,956		—
Restructuring expenses	—		—		8,197		7,420
Total costs and expenses	91,511		102,155		239,059		489,609
Operating income (loss)	1,595		(18,347)		(28,422)		(252,547)
Other income (expense):
Interest expense	(6,798)		(6,419)		(20,101)		(19,199)
Interest and dividend income	246		840		1,050		3,650
Other income	14,606		218		15,894		561
Total other income (expense), net	8,054		(5,361)		(3,157)		(14,988)
Income (loss) before income taxes	9,649		(23,708)		(31,579)		(267,535)
Income tax (benefit) expense	(53)		232		(113)		(26)
Net income (loss)	$	9,702	$	(23,940)	$	(31,466)	$	(267,509)
Net income (loss) per share:
Basic	$	0.28	$	(0.71)	$	(0.92)	$	(7.85)
Diluted	$	0.28	$	(0.71)	$	(0.92)	$	(7.85)
Weighted average shares outstanding used to compute net income (loss) per share:
Basic	34,484		33,906		34,314		34,058
Diluted	34,720		33,906		34,314		34,058

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

5

AMAG PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(IN THOUSANDS)

(Unaudited)

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Net income (loss)	$	9,702	$	(23,940)	$	(31,466)	$	(267,509)
Other comprehensive loss:
Unrealized (losses) gains on securities, net of tax	(104)		(167)		171		786
Total comprehensive income (loss)	$	9,598	$	(24,107)	$	(31,295)	$	(266,723)

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

6

AMAG PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(IN THOUSANDS, EXCEPT SHARES)

(Unaudited)

	Common Stock
	Shares	Amount		Additional Paid-in Capital		Accumulated Other Comprehensive Loss		Accumulated Deficit		Total Stockholders' Equity
Balance at July 1, 2020	34,463,373	$	344	$	1,303,095	$	(2,964)	$	(1,056,369)	$	244,106
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings	40,062	1		94		—		—		95
Non-cash equity based compensation	—	—		2,223		—		—		2,223
Unrealized losses on securities, net of tax	—	—		—		(104)		—		(104)
Net income	—	—		—		—		9,702		9,702
Balance at September 30, 2020	34,503,435	$	345	$	1,305,412	$	(3,068)	$	(1,046,667)	$	256,022

	Common Stock
	Shares	Amount		Additional Paid-in Capital		Accumulated Other Comprehensive Loss		Accumulated Deficit		Total Stockholders' Equity
Balance at January 1, 2020	33,999,081	$	339	$	1,297,917	$	(3,239)	$	(1,015,201)	$	279,816
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings	408,152	5		(1,237)		—		—		(1,232)
Issuance of common stock under employee stock purchase plan	96,202	1		630		—		—		631
Non-cash equity based compensation	—	—		8,102		—		—		8,102
Unrealized gains on securities, net of tax	—	—		—		171		—		171
Net loss	—	—		—		—		(31,466)		(31,466)
Balance at September 30, 2020	34,503,435	$	345	$	1,305,412	$	(3,068)	$	(1,046,667)	$	256,022

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

7

AMAG PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(IN THOUSANDS, EXCEPT SHARES)

(Unaudited)

	Common Stock
	Shares	Amount		Additional Paid-in Capital		Accumulated Other Comprehensive Loss		Accumulated Deficit		Total Stockholders' Equity
Balance at July 1, 2019	33,899,954	$	339	$	1,287,553	$	(3,032)	$	(791,109)	$	493,751
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings	15,555	—		(69)		—		—		(69)
Non-cash equity based compensation	—	—		4,974		—		—		4,974
Unrealized losses on securities, net of tax	—	—		—		(167)				(167)
Net loss	—	—		—		—		(23,940)		(23,940)
Balance at September 30, 2019	33,915,509	$	339	$	1,292,458	$	(3,199)	$	(815,049)	$	474,549

	Common Stock
	Shares	Amount		Additional Paid-in Capital		Accumulated Other Comprehensive Loss		Accumulated Deficit		Total Stockholders' Equity
Balance at January 1, 2019	34,606,760	$	346	$	1,292,736	$	(3,985)	$	(547,540)	$	741,557
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings	278,474	3		(1,790)		—		—		(1,787)
Issuance of common stock under employee stock purchase plan	105,075	1		850		—		—		851
Repurchase of common stock pursuant to the share repurchase program	(1,074,800)	(11)		(13,719)		—		—		(13,730)
Non-cash equity based compensation	—	—		14,381		—		—		14,381
Unrealized gains on securities, net of tax	—	—		—		786		—		786
Net loss	—	—		—		—		(267,509)		(267,509)
Balance at September 30, 2019	33,915,509	$	339	$	1,292,458	$	(3,199)	$	(815,049)	$	474,549

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

8

AMAG PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(IN THOUSANDS)

(Unaudited)

	Nine Months Ended September 30,
	2020		2019
Cash flows from operating activities:
Net loss	$	(31,466)	$	(267,509)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	22,276		13,871
Impairment of intangible assets	—		77,358
Provision for bad debt expense	230		(12)
Amortization of premium/discount on purchased securities	94		(64)
Write-down of inventory	1,916		4,872
Loss on disposal of property & equipment	273		—
Non-cash equity-based compensation expense	8,100		14,381
Non-cash IPR&D expense	—		18,029
Amortization of debt discount and debt issuance costs	12,300		11,332
Gains on marketable securities, net	(10)		(263)
Change in fair value of contingent consideration	—		(16)
Deferred income taxes	630		408
Non-cash lease expense	1,416		—
Gain on sale of assets	7,047		—
Changes in operating assets and liabilities:
Accounts receivable, net	26,328		(2,229)
Inventories	(676)		(6,824)
Prepaid and other current assets	(5,797)		(24,075)
Accounts payable and accrued expenses	(58,258)		54,073
Deferred revenues	9,461		(101)
Other assets and liabilities	(627)		1,038
Net cash used in operating activities	(6,763)		(105,731)
Cash flows from investing activities:
Proceeds from sales or maturities of marketable securities	43,675		85,321
Purchase of marketable securities	(55,763)		(14,815)
Milestone payment for Vyleesi developed technology	—		(60,000)
Net proceeds from the sale of assets	4,920		—
Capital expenditures	(475)		(2,098)
Net cash (used in) provided by investing activities	(7,643)		8,408
Cash flows from financing activities:
Payments to settle convertible notes	—		(21,417)
Payments of contingent consideration	(17)		(50)
Payments for repurchases of common stock	—		(13,730)
Proceeds from the issuance of common stock under the ESPP	630		851
Proceeds from the exercise of common stock options	168		30
Payments of employee tax withholding related to equity-based compensation	(1,400)		(1,817)
Net cash used in financing activities	(619)		(36,133)
Net decrease in cash, cash equivalents, and restricted cash	(15,025)		(133,456)
Cash, cash equivalents, and restricted cash at beginning of the period	113,504		253,751
Cash, cash equivalents, and restricted cash at end of the period	$	98,479	$	120,295
Supplemental data for cash flow information:
Cash (refunded) paid for taxes	$	(254)	$	456
Cash paid for interest	$	5,200	$	5,467
Non-cash investing and financing activities:
Settlement of note receivable in connection with Perosphere acquisition	$	—	$	10,000
Right-of-use assets obtained in exchange for lease liabilities	$	—	$	918

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

9

AMAG PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

A.     DESCRIPTION OF BUSINESS

AMAG Pharmaceuticals, Inc., a Delaware corporation, was founded in 1981. Throughout this Quarterly Report on Form 10-Q, AMAG Pharmaceuticals, Inc. and our consolidated subsidiaries are collectively referred to as “the Company,” “AMAG,” “we,” “us,” or “our.” We are a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs by leveraging our development and commercial expertise to invest in and grow our pharmaceutical products and product candidates across a range of therapeutic areas. As of September 30, 2020, we marketed products that support the health of patients in the areas of hematology and maternal health, including Feraheme® (ferumoxytol injection) for intravenous use and Makena® (hydroxyprogesterone caproate injection) auto-injector. In addition to our approved products, our portfolio includes ciraparantag, a product candidate that is being studied as an anticoagulant reversal agent.

In December 2019, we completed a review of our product portfolio and strategy. This strategic review resulted in our intention to divest our women’s health assets, as announced in January 2020, and as previously disclosed, we completed the divestiture of Intrarosa® (prasterone) during the second quarter of 2020. We completed the divestiture of our remaining women’s health asset, Vyleesi® (bremelanotide injection), in July 2020, which we determined did not meet the criteria for presentation as a discontinued operation, as it did not represent a strategic shift to our business as described above. For additional details on our divestiture of Vyleesi, refer to Note O, “Acquisitions, Collaboration, License and other Strategic Agreements”.

In July 2020, we also decided to stop the AMAG-423 Phase 2b/3a study based, primarily, on the results of an interim analysis conducted by the study’s independent Data Safety Monitoring Board (“DSMB”). For additional details on our decision to stop the AMAG 423 study, refer to Note O, “Acquisitions, Collaboration, License and other Strategic Agreements”.

On October 1, 2020, we entered into an Agreement and Plan of Merger with Covis Group S.à r.l., a Luxembourg company (“Covis”), Covis Mergerco Inc., a Delaware corporation and an indirect wholly owned subsidiary of Covis (“Merger Sub”), and (in respect of specific matters) Covis Finco S.à r.l., a Luxembourg company (the “Merger Agreement”), pursuant to which Merger Sub launched a cash tender offer (the “Offer”) to acquire all of the issued and outstanding shares of common stock of AMAG at a price per share of $13.75, net to the seller in cash, without interest. The Offer commenced on October 15, 2020 and will remain open for a minimum of 20 business days. The completion of the Offer is subject to customary closing conditions. For additional information, see Note T, “Subsequent Events”.

On October 5, 2020, we received notice of the FDA’s Center for Drug Evaluation and Research proposal to withdraw marketing approval of Makena and notice of our opportunity to request a hearing. For additional information, refer to Note T, “Subsequent Events”.

COVID-19

The global spread of COVID-19 has created significant volatility, uncertainty and economic disruption on a global scale, including in the United States, where we market our products, where our operations and employees reside and where we conduct clinical trials. The COVID-19 pandemic did not significantly impact our financial results during the three months ended September 30, 2020. The extent to which the COVID-19 pandemic impacts our business, operations and financial results in the future will depend on numerous evolving factors that we may not be able to accurately predict. While there have been no material impairments to date, any prolonged material disruptions to our sales, supply, research and development efforts and/or operations could negatively impact the Company’s business, operations and/or financial results.

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 our financial position and results of operations 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 (“GAAP”).

In accordance with GAAP 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 Consolidated Financial Statements in our

10

Annual Report on Form 10-K for the year ended December 31, 2019, as amended (our “Annual Report”). 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.

Principles of Consolidation

The accompanying condensed consolidated financial statements include our accounts and the accounts of our wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.

Use of Estimates and Assumptions

The preparation of our condensed consolidated financial statements in conformity with GAAP requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent liabilities. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity and the amount of revenues and expenses. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including product sales revenue; product sales allowances and accruals; allowance for expected credit losses; marketable securities; inventory; fair value estimates used to assess impairment of long-lived assets, including goodwill and other intangible assets; debt obligations; certain accrued liabilities, including clinical trial accruals; equity-based compensation expense; and income taxes, inclusive of valuation allowances, will depend on future developments that are highly uncertain, including new information that may emerge concerning COVID-19 and the actions taken to contain or treat its impact, as well as the economic impact on local, regional and national customers and markets. We have made estimates of the impact of COVID-19 within our financial statements and there may be changes to those estimates in future periods. Actual results could differ materially from these estimates.

Concentrations and Significant Customer Information

Financial instruments which potentially subject us to concentrations of credit risk consist principally of cash and cash equivalents, marketable securities, and accounts receivable. As of September 30, 2020, we held our excess cash primarily in institutional money market funds, corporate debt securities, commercial paper, U.S. treasury and government agency securities and certificates of deposit. As of September 30, 2020, we did not have a material concentration in any single investment.

Our operations are located entirely within the U.S. We focus primarily on developing, manufacturing, and commercializing our products and product candidates. The following table sets forth customers who represented 10% or more of our total revenues for the three and nine months ended September 30, 2020 and 2019:

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
McKesson Corporation	36	%	38	%	36	%	37	%
AmerisourceBergen Drug Corporation	32	%	28	%	33	%	27	%
Cardinal Health	12	%	11	%	11	%	12	%

Our net accounts receivable primarily represent amounts due for products sold directly to wholesalers, distributors and specialty pharmacies. Accounts receivable for our products are recorded net of reserves for estimated chargeback obligations, prompt payment discounts and any allowance for expected credit losses. At September 30, 2020, two customers accounted for 10% or more of our accounts receivable balances, representing approximately 76% in the aggregate of our total accounts receivable. At December 31, 2019, three customers accounted for 10% or more of our accounts receivable balances, representing approximately 85% in the aggregate of our total accounts receivable.

We are currently dependent on a single supplier for certain of our manufacturing processes, including for Feraheme drug substance (produced in two separate facilities) and for our Makena auto-injector product. We have been and may continue to be exposed to a significant loss of revenue from the sale of our products in the event that our suppliers and/or manufacturers are not able to fulfill demand for any reason.

11

Recently Adopted Accounting Pronouncements

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“Topic 326”). We adopted Topic 326 effective January 1, 2020 using a modified retrospective approach. The adoption of Topic 326 did not have a material impact on our condensed consolidated financial statements and accordingly, no transition adjustment was recorded at the adoption date. Under Topic 326, we estimate expected credit losses for our trade receivables held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. We also evaluate any impaired marketable securities against the new impairment model within Topic 326 to determine whether any loss or allowance for credit loss should be recorded at the reporting date.

In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”) as part of its Simplification Initiative to reduce the cost and complexity in accounting for income taxes. ASU 2019-12 removes certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. ASU 2019-12 also amends other aspects of the guidance to help simplify and promote consistent application of GAAP. The guidance is effective for interim and annual periods beginning after December 15, 2020, with early adoption permitted. We adopted ASU 2019-12 effective January 1, 2020. The adoption of ASU 2019-12 did not have a material impact on our condensed consolidated financial statements.

C.     REVENUE RECOGNITION

Product Revenue and Allowances and Accruals

The following table provides information about disaggregated revenue by product for the three and nine months ended September 30, 2020 and 2019 (in thousands):

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Product sales, net
Feraheme	$	46,718	$	44,205	$	120,786	$	126,294
Makena	25,860		33,949		66,079		95,483
Intrarosa	37		5,607		4,423		14,898
Other	614		23		(586)		156
Total product sales, net	$	73,229	$	83,784	$	190,702	$	236,831

Total gross product sales were offset by product sales allowances and accruals for the three and nine months ended September 30, 2020 and 2019 as follows (in thousands):

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Gross product sales	$	218,739	$	254,073	$	633,475	$	704,976
Provision for product sales allowances and accruals:
Contractual adjustments	129,966		144,108		383,003		381,633
Governmental rebates	15,544		26,181		59,770		86,512
Total	145,510		170,289		442,773		468,145
Product sales, net	$	73,229	$	83,784	$	190,702	$	236,831

The following table summarizes the product revenue allowance and accrual activity for the three and nine months ended September 30, 2020 (in thousands):

12

	Contractual		Governmental
	Adjustments		Rebates		Total
Balance at December 31, 2019	$	95,221	$	47,623	$	142,844
Provisions related to current period sales	147,235		20,982		168,217
Adjustments related to prior period sales	(4,060)		976		(3,084)
Payments/returns relating to current period sales	(95,284)		—		(95,284)
Payments/returns relating to prior period sales	(37,969)		(29,646)		(67,615)
Balance at March 31, 2020	$	105,143	$	39,935	$	145,078
Provisions related to current period sales	111,508		21,904		133,412
Adjustments related to prior period sales	(634)		378		(256)
Payments/returns relating to current period sales	(112,821)		(13,913)		(126,734)
Payments/returns relating to prior period sales	(19,484)		(10,240)		(29,724)
Balance at June 30, 2020	$	83,712	$	38,064	$	121,776
Provisions related to current period sales	129,402		17,410		146,812
Adjustments related to prior period sales	565		(1,867)		(1,302)
Payments/returns relating to current period sales	(115,634)		(14,259)		(129,893)
Payments/returns relating to prior period sales	(5,803)		(830)		(6,633)
Balance at September 30, 2020	$	92,242	$	38,518	$	130,760

Collaboration Revenue

In July 2020, we entered into a License and Commercialization Agreement with Norgine B.V. (“Norgine”, and such agreement, the “Norgine Agreement”), pursuant to which we granted Norgine an exclusive license to develop and commercialize ciraparantag in certain countries in Europe, Australia and New Zealand (the “Norgine Territory”). We received a $30.0 million upfront payment upon signing. In addition, pursuant to the terms and conditions of the Norgine Agreement (a) Norgine will pay us one-third of the actual and reasonable out-of-pocket costs of the Phase 3 program, pursuant to a mutually agreed upon budget, (b) we are eligible to receive up to $70.0 million upon the achievement of certain regulatory milestones (of which we will pay $40.0 million to the former equity holders of Perosphere pursuant to the terms of the Perosphere Agreement (described below), (c) we are eligible to receive up to $190.0 million contingent upon meeting certain sales milestones, and (d) Norgine will pay us tiered double-digit royalties on net sales in the licensed territory. Norgine will be responsible for the regulatory filings and any clinical trials specifically required for approval of the Product in the Norgine Territory and will hold all marketing authorizations in the Norgine Territory. We will be responsible for manufacturing and supplying Norgine with its requirements of clinical and commercial product pursuant to supply agreement(s) to be entered into by the parties.

In accordance with ASC 808, we considered the nature and contractual terms of the arrangement and the nature of our business operations to determine the classification of payments under the Norgine Agreement and concluded that Norgine meets the definition of a customer. As a result, the Norgine Agreement was accounted for under ASC 606. We determined that the Norgine Agreement contains three distinct performance obligations: (i) delivery of a license granting rights to clinical data developed to date and rights to develop and commercialize ciraparantag in the Norgine Territory (the “License”), (ii) research and development services, and (iii) participation on the joint development and steering committees.

We allocated the upfront consideration to each performance obligation using the standalone selling prices based on our estimate of selling price for the License, research and development services and participation on the joint development and steering committees. To determine the standalone selling price for the License and for the participation on the joint development and joint steering committees, we used an adjusted market approach. For the License, the adjusted market approach included an assessment of the likelihood of achievement of certain regulatory milestones using third party evidence and the likelihood of regulatory approval of ciraparantag and the expected future cash flows assuming regulatory approval in the Norgine Territory, discounting these cash flows using a risk adjusted discount rate of approximately 27%. For the research and development services we determined the standalone selling pricing using a cost plus margin approach. For the joint development and joint steering committees, the adjusted market approach included an assessment of consulting rates prevalent in the marketplace.

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Under Topic 606, we allocated the $30.0 million upfront payment as follows: $19.8 million to the License and $10.2 million to the research and development services. No consideration was allocated to the performance obligation related to participation on the joint development and steering committees, as its standalone selling price was not material. The amounts allocated to the licenses were recognized upon delivery of the licenses during the three months ended September 30, 2020. The amount allocated to the development services will be recognized over the course of the development work using an input method in the form of development effort relative to expected total development effort at the completion of the development services. This is based on the relative costs of the development activities incurred and expected to be incurred in the future to satisfy the performance obligation. The estimated period of performance to satisfy the performance obligation and project cost will be reviewed periodically and adjusted, as needed, to reflect our current expectations regarding the costs and timing of the deliverable. These estimates are subject to a number of assumptions and actual results could differ materially from our assumptions in future periods.

We determined that the future regulatory and sales-based milestone and sales-based royalty payments that we may be entitled to receive are variable consideration. We are using a most likely amount method for estimating the variable consideration to be received related to regulatory milestones under this arrangement. All future potential regulatory milestones were fully constrained at September 30, 2020. The sales-based milestones and royalties are subject to the sales-and-usage-based royalty exception related to a license of intellectual property and will be recorded in the period when the corresponding sale occurs.

As of September 30, 2020, deferred revenue related to the development services performance obligation amounted to $10.2 million, of which $2.5 million was included in current liabilities.

In addition, the Company incurred approximately $2.0 million of contract acquisition costs related to the Norgine Agreement. These costs are expensed as selling, general and administrative expense based on the transfer of control of the underlying performance obligations, as determined on a relative standalone selling price basis. As of September 30, 2020, the Company recorded approximately $1.3 million in selling, general and administrative expense and deferred $0.7 million as a component of other long-term assets.

D.    MARKETABLE SECURITIES

As of September 30, 2020 and December 31, 2019, our marketable securities 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 marketable securities.

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The following is a summary of our marketable securities as of September 30, 2020 and December 31, 2019 (in thousands):

	September 30, 2020
			Gross		Gross		Estimated
	Amortized		Unrealized		Unrealized		Fair
	Cost		Gains		Losses		Value
Securities maturing within one year:
Corporate debt securities	$	23,861	$	145	$	(1)	$	24,005
Certificates of deposit	14,300		—		—		14,300
Commercial paper	9,488		—		—		9,488
Total securities maturing within one year	$	47,649	$	145	$	(1)	$	47,793
Securities maturing between one and three years:
Corporate debt securities	$	16,809	$	319	$	(2)	$	17,126
U.S. treasury and government agency securities	4,998		—		—		4,998
Certificates of deposit	1,000		—		—		1,000
Total securities maturing between one and three years	$	22,807	$	319	$	(2)	$	23,124
Total marketable securities	$	70,456	$	464	$	(3)	$	70,917

	December 31, 2019
			Gross		Gross		Estimated
	Amortized		Unrealized		Unrealized		Fair
	Cost		Gains		Losses		Value
Securities maturing within one year:
Corporate debt securities	$	46,186	$	140	$	(2)	$	46,324
U.S. treasury and government agency securities	2,750		—		—		2,750
Certificates of deposit	1,500		—		—		1,500
Total securities maturing within one year	$	50,436	$	140	$	(2)	$	50,574
Securities maturing between one and three years:
Corporate debt securities	$	8,016	$	152	$	—	$	8,168
Total securities maturing between one and three years	8,016		152		—		8,168
Total marketable securities	$	58,452	$	292	$	(2)	$	58,742

E.     FAIR VALUE MEASUREMENTS

The following tables present information about our assets and liabilities that we measure at fair value on a recurring basis and indicate the level within the fair value hierarchy of the valuation techniques utilized to determine such fair value as of September 30, 2020 and December 31, 2019 (in thousands):

	Fair Value Measurements at September 30, 2020 Using:
			Quoted Prices in				Significant
			Active Markets for		Significant Other		Unobservable
			Identical Assets		Observable Inputs		Inputs
	Total		(Level 1)		(Level 2)		(Level 3)
Assets:
Cash equivalents	$	2,750	$	2,750	$	—	$	—
Corporate debt securities	41,131		—		41,131		—
U.S. treasury and government agency securities	4,998				4,998		—
Certificates of deposit	15,300		—		15,300		—
Commercial paper	9,488				9,488		—
Total assets	$	73,667	$	2,750	$	70,917	$	—

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	Fair Value Measurements at December 31, 2019 Using:
			Quoted Prices in				Significant
			Active Markets for		Significant Other		Unobservable
			Identical Assets		Observable Inputs		Inputs
	Total		(Level 1)		(Level 2)		(Level 3)
Assets:
Cash equivalents	$	13,732	$	13,732	$	—	$	—
Corporate debt securities	54,492		—		54,492		—
U.S. treasury and government agency securities	2,750		—		2,750		—
Certificates of deposit	1,500		—		1,500		—
Total assets	$	72,474	$	13,732	$	58,742	$	—
Liabilities:
Contingent consideration - MuGard	$	17	$	—	$	—	$	17
Total liabilities	$	17	$	—	$	—	$	17

Cash Equivalents

Our cash equivalents are classified as Level 1 assets under the fair value hierarchy as these assets have been valued using quoted market prices in active markets and do not have any restrictions on redemption. As of September 30, 2020 and December 31, 2019, cash equivalents were primarily comprised of funds in money market accounts.

Marketable Securities

Our marketable securities are classified as Level 2 assets under the fair value hierarchy as the values of these assets are primarily determined from independent pricing services, which 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 a quantitative and qualitative analysis of prices received from third parties to determine whether prices are reasonable estimates of fair value. After completing our analysis, we did not adjust or override any fair value measurements provided by our pricing services as of September 30, 2020. In addition, there were no transfers or reclassifications of any securities between Level 1 and Level 2 during the nine months ended September 30, 2020.

Debt

We estimate the fair value of our debt obligations using quoted market prices obtained from third-party pricing services, which are classified as Level 2 inputs. As of September 30, 2020, the estimated fair value of our 2022 Convertible Notes (as defined in Note P, “Debt” below) was $289.7 million, which differed from its carrying value. See Note P, “Debt” for additional information on our debt obligations.

F.     INVENTORIES

Our major classes of inventories were as follows as of September 30, 2020 and December 31, 2019 (in thousands):

	September 30, 2020		December 31, 2019
Raw materials	$	3,424	$	5,211
Work in process	6,495		6,248
Finished goods	12,987		20,094
Total inventories	$	22,906	$	31,553

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G.     PROPERTY AND EQUIPMENT, NET

Property and equipment, net consisted of the following as of September 30, 2020 and December 31, 2019 (in thousands):

	September 30, 2020		December 31, 2019
Computer equipment and software	$	1,568	$	1,568
Furniture and fixtures	1,714		1,714
Leasehold improvements	4,985		4,984
Laboratory and production equipment	6,281		6,570
Construction in progress	361		656
	14,909		15,492
Less: accumulated depreciation	(12,494)		(11,376)
Property and equipment, net	$	2,415	$	4,116

H.     GOODWILL AND INTANGIBLE ASSETS, NET

Goodwill

As of September 30, 2020, we had no accumulated impairment losses related to goodwill.

Intangible Assets

As of September 30, 2020 and December 31, 2019, our intangible assets consisted of the following (in thousands):

	September 30, 2020								December 31, 2019
			Accumulated		Cumulative						Accumulated		Cumulative
	Cost		Amortization		Impairments		Net		Cost		Amortization		Impairments		Net
Amortizable intangible assets:
Makena auto-injector developed technology	$	79,100	$	21,701	$	55,426	$	1,973	$	79,100	$	15,782	$	55,426	$	7,892
Intrarosa developed technology	—		—		—		—		77,655		16,798		56,881		3,976
Vyleesi developed technology	—		—		—		—		60,000		9,264		38,984		11,752
Total intangible assets	$	79,100	$	21,701	$	55,426	$	1,973	$	216,755	$	41,844	$	151,291	$	23,620

In May 2020, we sold all of our rights to Intrarosa and accordingly, wrote off the related developed technology intangible asset. In July 2020, we completed the divestiture of Vyleesi and accordingly, wrote off the related developed technology intangible asset, which was fully amortized as of June 30, 2020.

As of September 30, 2020, the weighted average remaining amortization period for our finite-lived intangible assets was less than one year. Total amortization expense for the nine months ended September 30, 2020 and 2019 was $20.8 million and $12.1 million, respectively. Amortization expense is recorded in cost of product sales on our condensed consolidated statements of operations. We expect our finite-lived intangible assets to be fully amortized in 2020.

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I.     CURRENT LIABILITIES

Accrued expenses consisted of the following as of September 30, 2020 and December 31, 2019 (in thousands):

	September 30, 2020		December 31, 2019
Commercial rebates, fees and returns	$	106,367	$	124,730
Manufacturing costs	8,778		21,364
Salaries, bonuses, and other compensation	13,121		18,693
Professional, license, and other fees and expenses	12,403		13,392
Research and development expense	865		3,539
Interest expense	3,467		867
Restructuring expense	1,596		797
Total accrued expenses	$	146,597	$	183,382

J.     INCOME TAXES

The following table summarizes our effective tax rate and income tax (benefit) expense for the three and nine months ended September 30, 2020 and 2019 (in thousands except for percentages):

	Three Months Ended September 30,						Nine Months Ended September 30,
	2020			2019			2020			2019
Effective tax rate	(1)		%	(1)		%	—		%	—		%
Income tax (benefit) expense	$	(53)		$	232		$	(113)		$	(26)

For the three and nine months ended September 30, 2020, we recognized an immaterial income tax benefit, representing an effective tax rate of (1)% and 0%, respectively. The difference between the statutory federal tax rate of 21% and the effective tax rates for the three and nine months ended September 30, 2020, was primarily attributable to the valuation allowance established against our current period losses generated. We have established a valuation allowance on our deferred tax assets to the extent that our existing taxable temporary differences would not be available as a source of income to realize the benefits of those deferred tax assets. The income tax benefit for the three and nine months ended September 30, 2020 primarily related to state income taxes.

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act was signed into law making several changes to the Internal Revenue Code. The changes include, but are not limited to, temporarily increasing the limitation on the amount of deductible interest expense, allowing taxpayers with alternative minimum tax credits to claim a refund for the entire amount of the credit instead of recovering the credit through refunds over a period of years, as required by the 2017 Tax Cuts and Jobs Act, allowing companies to carryback certain net operating losses, and temporarily increasing the amount of net operating loss carryforwards that corporations can use to offset taxable income. The tax law changes in the CARES Act did not have a material impact on our income tax provision.

For the three and nine months ended September 30, 2019, we recognized an immaterial income tax expense and an immaterial income tax benefit, representing an effective tax rate of (1)% and 0%, respectively. The income tax expense for the three months ended September 30, 2019 primarily related to state income taxes. The income tax benefit for the nine months ended September 30, 2019 primarily related to the offset of the recognition of the income tax expense recorded in other comprehensive loss associated with the increase in the fair value of the available-for-sale debt securities that we carried at fair market value during the period, partially offset by state income taxes. The difference between the statutory federal tax rate of 21% and the effective tax rate of (1)% and 0% for the three and nine months ended September 30, 2019, respectively, was primarily attributable to the valuation allowance established against our current period losses generated and the non-deductible IPR&D expense related to the Perosphere acquisition.

K.     EARNINGS PER SHARE

The components of basic and diluted earnings per share for the three and nine months ended September 30, 2020 and 2019 were as follows (in thousands, except per share data):

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	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Net income (loss) - basic and diluted	$	9,702	$	(23,940)	$	(31,466)	$	(267,509)
Weighted average common shares outstanding	34,484		33,906		34,314		34,058
Effect of dilutive securities:
Stock options and RSUs	236		—		—		—
Shares used in calculating dilutive net income (loss) per share	34,720		33,906		34,314		34,058
Net income (loss) per share:
Basic	$	0.28	$	(0.71)	$	(0.92)	$	(7.85)
Diluted	$	0.28	$	(0.71)	$	(0.92)	$	(7.85)

The following table sets forth the potential common shares issuable upon the exercise of outstanding options, the vesting of restricted stock units (“RSUs”), and the conversion of the 2022 Convertible Notes, which were excluded from our computation of diluted net income (loss) per share because their inclusion would have been anti-dilutive (in thousands):

	Nine Months Ended September 30,
	2020	2019
Options to purchase shares of common stock	4,233	3,988
Shares of common stock issuable upon the vesting of RSUs	1,035	1,645
2022 Convertible Notes	11,695	11,695
Total	16,963	17,328

L.     EQUITY-BASED COMPENSATION

We currently maintain three equity compensation plans; our 2019 Equity Incentive Plan (the “2019 Plan”), which was approved by our stockholders at our 2019 annual meeting and replaced our Fourth Amended and Restated 2007 Equity Incentive Plan (the “2007 Plan”), the Lumara Health Inc. Amended and Restated 2013 Incentive Compensation Plan (the “Lumara Health 2013 Plan”) and our 2015 Employee Stock Purchase Plan (“2015 ESPP”). All outstanding stock options granted under each of our equity compensation plans other than our 2015 ESPP have an exercise price equal to the closing price of a share of our common stock on the grant date.

During 2020, we also granted equity through inducement grants outside of our equity compensation plans to certain employees to induce them to accept employment with us (collectively, “Inducement Grants”). The options were granted at an exercise price equal to the fair market value of a share of our common stock on the respective grant dates and will become exercisable in four equal annual installments beginning on the first anniversary of the respective grant dates. The foregoing grants were made pursuant to inducement grants outside of our stockholder approved equity plans as permitted under the NASDAQ Stock Market listing 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.

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Stock Options

The following table summarizes stock option activity for the nine months ended September 30, 2020:

	2019	2007	Lumara Health	Inducement
	Plan	Plan	2013 Plan	Grants	Total
Outstanding at January 1, 2020	472,412	2,585,466	131,775	696,164	3,885,817
Granted	420,912	—	—	1,000,000	1,420,912
Exercised	(18,487)	—	(1,450)	—	(19,937)
Expired or terminated	(149,863)	(672,295)	(43,250)	(188,098)	(1,053,506)
Outstanding at September 30, 2020	724,974	1,913,171	87,075	1,508,066	4,233,286

Restricted Stock Units

The following table summarizes RSU activity for the nine months ended September 30, 2020:

	2019	2007	Lumara Health	Inducement
	Plan	Plan	2013 Plan	Grants	Total
Outstanding at January 1, 2020	128,742	1,407,305	2,167	41,223	1,579,437
Granted	825,131	—	—	—	825,131
Vested	(78,689)	(460,185)	(899)	(10,862)	(550,635)
Expired or terminated	(209,697)	(591,972)	(534)	(17,169)	(819,372)
Outstanding at September 30, 2020	665,487	355,148	734	13,192	1,034,561

Equity-Based Compensation Expense

Equity-based compensation expense for the three and nine months ended September 30, 2020 and 2019 consisted of the following (in thousands):

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Cost of product sales	$	131	$	225	$	438	$	626
Research and development	237		691		260		2,051
Selling, general and administrative	1,854		4,058		7,403		11,039
Total equity-based compensation expense	2,222		4,974		8,101		13,716
Income tax effect	—		—		—		—
After-tax effect of equity-based compensation expense	$	2,222	$	4,974	$	8,101	$	13,716

In addition to the equity-based compensation expense presented in the table above, we incurred $0.7 million of equity-based compensation expense related to restructuring activities during the first quarter of 2019 (as discussed further in Note Q, below), which is classified within restructuring expense on our condensed consolidated statements of operations for the nine months ended September 30, 2019.

M.     STOCKHOLDERS’ EQUITY

As of January 1, 2020, we had $26.8 million available under the share repurchase program initially approved by our Board of Directors in January 2016, which was updated in March 2019 to permit the repurchase of up to an aggregate of $80.0 million in shares of our common stock. During the nine months ended September 30, 2020, we did not repurchase shares of common stock under this program. As of September 30, 2020, $26.8 million remains available for future repurchases under this program. 

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N.     COMMITMENTS AND CONTINGENCIES

Commitments

Our long-term contractual obligations include commitments and estimated purchase obligations entered into in the normal course of business. These include commitments related to our facility and vehicle leases, purchases of inventory, debt obligations, and other purchase obligations.

Operating Lease Obligations

As of September 30, 2020, we had operating lease liabilities of $21.9 million and related right-of-use assets of $21.1 million related to operating leases for real estate, including our corporate headquarters, vehicles and office equipment. As of September 30, 2020, our leases have remaining terms of one to eight years. The weighted average remaining lease term and discount rate for our operating leases was 7.4 years and 5.1% at September 30, 2020, respectively.

Lease costs for our operating leases were $1.2 million and $3.8 million for the three and nine months ended September 30, 2020, respectively and $1.4 million and $3.9 million for the three and nine months ended September 30, 2019, respectively. Operating cash outflows for operating leases were $3.6 million and $4.2 million for the nine months ended September 30, 2020 and 2019, respectively.

Future minimum payments under our non-cancelable operating leases as of September 30, 2020 are as follows (in thousands):

Period	Future Minimum Lease Payments
Remainder of Year Ending December 31, 2020	$	947
Year Ending December 31, 2021	3,248
Year Ending December 31, 2022	3,887
Year Ending December 31, 2023	3,291
Year Ending December 31, 2024	3,246
Thereafter	12,192
Total	$	26,811
Less: Interest	(4,924)
Operating lease liability	$	21,887

Purchase Obligations

Purchase obligations primarily represent minimum purchase commitments for inventory. As of September 30, 2020, our minimum purchase commitments totaled $25.9 million.

Contingent Regulatory and Commercial Milestone Payments

We are required to make payments contingent on the achievement of certain regulatory and/or commercial milestones under the terms of our collaboration, license and other strategic agreements. Please refer to Note O, “Acquisitions, Collaboration, License and Other Strategic Agreements” for additional details regarding these contingent payments.

Contingencies

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 certain 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. We expense legal costs as they are incurred.

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On June 5, 2020, Carrie Winchester and Matt Winchester filed a complaint against a list of defendants for claimed exposures to asbestos. AMAG Pharma USA, Inc. d/b/a Lumara Health Inc. was named as a defendant because Nesher Pharmaceuticals, Inc., a subsidiary of K-V Pharmaceutical Company (“KV”) (Lumara Health’s predecessor company), sold Nystatin powder that Ms. Winchester claims she may have used during her employment as a medical professional. We acquired Lumara Health in November 2014, a year after KV emerged from bankruptcy protection, at which time it, along with its then existing subsidiaries, became our wholly-owned subsidiary. The plaintiffs allege that Ms. Winchester developed injuries as a direct and proximate result of inhalation of asbestos dust particles and fibers from defendants’ products. On August 19, 2020, the plaintiffs dismissed the defendants, AMAG Pharma USA, Inc. d/b/a Lumara Health Inc. and Nesher Pharmaceuticals, Inc. without prejudice from this claim.

On November 6, 2019, we were served with a summons in a case filed in the U.S. District Court, Northern District of Ohio, captioned Civil Case in Saginaw Chippewa Indian Tribe v. Purdue Pharma et al (Case No. 1-19-op-45841). The complaint names KV, certain of its successor entities, subsidiaries and affiliate entities as defendants, along with over forty other pharmaceutical companies. The plaintiff in this action alleges that KV’s subsidiary, Ethex Corporation (as well as the other pharmaceutical companies named in the complaint), manufactured, promoted, sold, and distributed opioids, including a generic version of morphine. Defendants KV and Ethex Corporation were dismissed without prejudice from this Chippewa case pursuant to an order dated March 26, 2020. KV and Ethex were also named but not served in several other similar cases and were dismissed without prejudice from these other cases by orders dated March 26, 2020.

On November 1, 2019, we were named as a defendant in a class action lawsuit filed in the United States District Court for the Western District of Missouri, captioned Barnes v. AMAG Pharmaceuticals, Inc., Case No. 3:19-cv-05088-RK (W.D. Mo.). Subsequently, other plaintiffs represented by the same law firm filed similar class action lawsuits in other jurisdictions, and the lawsuits have been consolidated in the United States District Court for the District of New Jersey, Zamfirova et al. v. AMAG Pharmaceuticals, Inc., Case No. 20-00152-JMV-SCM (April 2, 2020). The plaintiffs in this action, on behalf of themselves and purported state-wide classes of similarly situated consumers in California, Kansas, Missouri, New Jersey, New York, and Wisconsin, assert claims for violation of state consumer protection laws and unjust enrichment based on allegations that we and/or our predecessor companies made misrepresentations and omissions regarding the effectiveness of Makena in connection with the sale and marketing of that product from 2011 through the present. On June 8, 2020, we filed a motion to dismiss the consolidated complaint. Plaintiffs responded with a brief in opposition to the motion on July 6, 2020. Our reply brief was filed on July 20, 2020. We are currently unable to predict the outcome or reasonably estimate the range of potential loss associated with this matter, if any.

On August 29, 2019, Lunar Representative, LLC (“Plaintiff”), on behalf of the former equity holders of Lumara Health Inc. (“Lumara”), filed a complaint against us in the Delaware Court of Chancery, captioned Lunar Representative, LLC v. AMAG Pharmaceuticals, Inc. (No. 2019-0688-JTL). On September 25, 2019, we filed a motion to dismiss the complaint. On January 9, 2020, Plaintiff filed an amended complaint. Plaintiff alleges that we did not exercise commercially reasonable efforts to market and sell the drug product Makena, and failed to achieve sales milestones for Makena, in breach of certain provisions of the September 28, 2014 Agreement and Plan of Merger between, among other parties, us and Lumara. On January 24, 2020, we filed a motion to dismiss the amended complaint and filed our opening brief in support of such motion to dismiss the amended complaint on April 14, 2020. Plaintiff filed an answer in opposition to the motion to dismiss on June 25, 2020. On August 21, 2020, the court denied our motion to dismiss. On September 18, 2020, we filed an answer to the amended complaint. Plaintiff is seeking damages of $50.0 million, together with pre- and post-judgment interest, as well as attorneys’ fees and costs. At this time, based on available information, we are unable to reasonably assess the ultimate outcome of this case or determine an estimate, or a range of estimates, of potential losses. We believe this lawsuit is without merit and intend to vigorously defend against the allegations.

On or about April 6, 2016, we received Notice of a Lawsuit and Request to Waive Service of a Summons in a case entitled Plumbers’ Local Union No. 690 Health Plan v. Actavis Group et. al. (“Plumbers’ Union”), which was filed in the Court of Common Pleas of Philadelphia County, First Judicial District of Pennsylvania and, after removal to federal court, is now pending in the United States District Court for the Eastern District of Pennsylvania (Civ. Action No. 16-65-AB). Thereafter, we were also made aware of a related complaint entitled Delaware Valley Health Care Coalition v. Actavis Group et. al. (“Delaware Valley”), which was filed with the Court of Common Pleas of Philadelphia County, First Judicial District of Pennsylvania District Court of Pennsylvania (Case ID: 160200806). Both the Plumbers’ Union and the Delaware Valley complaints name K-V Pharmaceutical Company (“KV”) (Lumara Health’s predecessor company), certain of its successor entities, subsidiaries and affiliate entities (the “Subsidiaries”), along with a number of other pharmaceutical companies. We acquired Lumara Health in November 2014, a year after KV emerged from bankruptcy protection, at which time it, along with its then existing subsidiaries, became our wholly-owned subsidiary. We have not been served with process or waived service of summons in either case. The actions are being brought alleging unfair and deceptive trade practices with regard to certain pricing practices that allegedly resulted in certain payers overpaying for certain of KV’s generic products. On July 21, 2016, the

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Plaintiff in the Plumbers’ Union case dismissed KV with prejudice to refiling and on October 6, 2016, all claims against the Subsidiaries were dismissed without prejudice. We are in discussions with Plaintiff’s counsel to similarly dismiss all claims in the Delaware Valley case. Because we have not been served with process in the Delaware Valley case, we are currently unable to predict the outcome or reasonably estimate the range of potential loss associated with this matter, if any.

On July 20, 2015, the Federal Trade Commission (the “FTC”) notified us that it is conducting an investigation into whether Lumara Health or its predecessor engaged in unfair methods of competition with respect to Makena or any hydroxyprogesterone caproate product. As previously disclosed, we provided the FTC with a response in August 2015. We believe we have fully cooperated with the FTC and we have had no further interactions with the FTC on this matter since we provided our response to the FTC in August 2015. For further information on this matter, see Note N, “Commitments and Contingencies” to our Annual Report.

We may periodically become subject to other legal proceedings and claims arising in connection with ongoing business activities, including claims or disputes related to patents that have been issued or that are pending in the field of research on which we are focused. Other than the above actions, we are not aware of any material claims against us as of September 30, 2020.

O.     ACQUISITIONS, COLLABORATION, LICENSE AND OTHER STRATEGIC AGREEMENTS

During the nine months ended September 30, 2020, we were a party to the following collaboration, license or other strategic agreements:

Norgine

In July 2020, we entered into a License and Commercialization Agreement with Norgine B.V. (“Norgine”, and such agreement, the “Norgine Agreement”), pursuant to which we granted Norgine an exclusive license to develop and commercialize ciraparantag in certain countries in Europe, Australia and New Zealand. We received a $30.0 million upfront, non-refundable payment upon signing. In addition, pursuant to the terms and conditions of the Norgine Agreement (a) Norgine will pay us one-third of the actual and reasonable out-of-pocket costs of the Phase 3 program, pursuant to a mutually agreed upon budget, (b) we are eligible to receive up to $70.0 million upon the achievement of certain regulatory milestones (of which we will pay $40.0 million to the former equity holders of Perosphere pursuant to the terms of the Perosphere Agreement (described below), (c) we are eligible to receive up to $190.0 million contingent upon meeting certain sales milestones, and (d) Norgine will pay us tiered double-digit royalties on net sales in the licensed territory. We will be responsible for manufacturing and supplying Norgine with its requirements of clinical and commercial product pursuant to supply agreement(s) to be entered into by the parties.

Perosphere

On January 16, 2019, we acquired Perosphere pursuant to the Agreement and Plan of Merger (the “Perosphere Agreement”), dated as of December 12, 2018 between AMAG and Perosphere. We accounted for this transaction as an asset acquisition under ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business (“ASU 2017-01”).

Under and subject to the terms and conditions set forth in the Perosphere Agreement, we are obligated to pay future contingent consideration of up to an aggregate of $365.0 million (the “Milestone Payments”), including (a) up to an aggregate of $140.0 million that becomes payable upon the achievement of specified regulatory milestones for ciraparantag (the “Regulatory Milestone Payments”), including a $40.0 million milestone payment upon approval of ciraparantag by the European Medicines Agency and (b) up to an aggregate of $225.0 million that becomes payable conditioned upon the achievement of specified sales milestones (the “Sales Milestone Payments”). If the final label approved for ciraparantag in the U.S. includes a boxed warning, the Regulatory Milestone Payments shall no longer be payable, and any previously paid Regulatory Milestone Payments shall be credited against 50% of any future Milestone Payments that otherwise becomes payable. The first sales milestone payment of $20.0 million will be payable upon annual net sales of ciraparantag of at least $100.0 million.

Velo

In September 2018, we exercised our option to acquire the global rights to the AMAG-423 program, pursuant to an option agreement entered into in July 2015 (the “Velo Option Agreement”) with Velo Bio, LLC (“Velo”), the terms of which were amended at the time of exercise. We accounted for this transaction as an asset acquisition under ASU No. 2017-01. Under the terms of the agreement, we are obligated to pay Velo a $30.0 million milestone payment upon FDA approval of AMAG-423. In

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addition, we are obligated to pay sales milestone payments to Velo of up to $240.0 million in the aggregate, triggered at various annual net sales thresholds between $300.0 million and $900.0 million and low-single digit royalties based on net sales. Further, we have assumed additional obligations under a previous agreement entered into by Velo with a third-party, including a $5.0 million milestone payment upon regulatory approval and $10.0 million following the first commercial sale of AMAG-423, payable in quarterly installments as a percentage of quarterly gross commercial sales until the obligation is met. We are also obligated to pay the third-party low-single digit royalties based on net sales.

In July 2020, we decided to stop the AMAG-423 Phase 2b/3a study. This decision was based primarily on DSMB unanimous recommendation to stop the study following an interim analysis of the data collected to date in the study. There were no safety concerns raised during this study and safety was not a contributing factor to our decision to terminate the study. We are currently focused on ensuring an appropriate closeout of the study in partnership with investigators and other relevant stakeholders.

In connection with the cessation of the AMAG-423 Phase 2b/3a study, on August 6, 2020, we terminated our supply agreement (including termination of significant minimum purchase obligations) with our third party supplier, Protherics UK Ltd, a subsidiary of BTG plc (“BTG”), in exchange for a one-time payment by us of $12.5 million and our grant to BTG of a 9-month option (subject to extension under certain situations) to acquire the AMAG-423 program rights and assume our related obligations, including our obligations under the Velo Option Agreement.

Antares

We are party to a development and license agreement (the “Antares License Agreement”) with Antares Pharma, Inc. (“Antares”), which grants us an exclusive, worldwide, royalty-bearing license, with the right to sublicense, to certain intellectual property rights, including know-how, patents and trademarks, to develop, use, sell, offer for sale and import and export the Makena auto-injector. Under the terms of the Antares License Agreement, as amended in March 2018, we are responsible for the clinical development and preparation, submission and maintenance of all regulatory applications in each country where we desire to market and sell the Makena auto-injector, including the U.S. We are required to pay royalties to Antares on net sales of the Makena auto-injector until the Antares License Agreement is terminated (the “Antares Royalty Term”). The royalty rates range from high single digit to low double digits and are tiered based on levels of net sales of the Makena auto-injector and decrease after the expiration of licensed patents or where there are generic equivalents to the Makena auto-injector being sold in a particular country. In addition, we are required to pay Antares sales milestone payments upon the achievement of certain annual net sales. The Antares License Agreement terminates at the end of the Antares Royalty Term, but is subject to early termination by us for convenience and by either party upon an uncured breach by or bankruptcy of the other party. In March 2018, the Antares License Agreement was amended to, among other things, transfer the agreement to AMAG from our subsidiary, amend certain confidentiality provisions, and to provide for co-termination with the Antares Manufacturing Agreement (described below).

We are also party to a Manufacturing Agreement with Antares (the “Antares Manufacturing Agreement”) that sets forth the terms and conditions pursuant to which Antares agreed to sell to us on an exclusive basis, and we agreed to purchase, the fully packaged Makena auto-injector for commercial distribution. Antares remains responsible for the manufacture and supply of the device components and assembly of the Makena auto-injector. We are responsible for the supply of the drug to be used in the assembly of the finished auto-injector product. The Antares Manufacturing Agreement terminates at the expiration or earlier termination of the Antares License Agreement, but is subject to early termination by us for certain supply failure situations, and by either party upon an uncured breach by or bankruptcy of the other party or our permanent cessation of commercialization of the Makena auto-injector for efficacy or safety reasons.

Endoceutics

In February 2017, we entered into the Endoceutics License Agreement with Endoceutics, Inc. (“Endoceutics”) to obtain an exclusive right to commercialize Intrarosa for the treatment of vulvar and vaginal atrophy (“VVA”) and female sexual dysfunction (“FSD”) in the United States. The transactions contemplated by the Endoceutics License Agreement closed on April 3, 2017. We accounted for the Endoceutics License Agreement as an asset acquisition under ASU 2017-01.

In April 2017, we entered into an exclusive commercial supply agreement with Endoceutics pursuant to which Endoceutics, itself or through affiliates or contract manufacturers, agreed to manufacture and supply Intrarosa to us (the “Endoceutics Supply Agreement”) and was our exclusive supplier of Intrarosa in the U.S., subject to certain rights for us to manufacture and supply Intrarosa in the event of a cessation notice or supply failure (as such terms are defined in the Endoceutics Supply Agreement).

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On May 21, 2020, we sold our rights to commercialize and have manufactured Intrarosa in the United States to Millicent Pharma Limited (“Millicent”) pursuant to an Asset Purchase Agreement between the Company and Millicent, dated May 21, 2020. Under the terms of the Asset Purchase Agreement, we received an upfront payment of $20.9 million in cash, subject to customary purchase price adjustments, including in connection with the transfer of certain inventory. We are eligible to receive up to $105.0 million in aggregate milestone payments upon the achievement of certain sales milestones, namely: (a) $25.0 million the first time net sales during any consecutive twelve month period exceeds $65.0 million, (b) $35.0 million the first time net sales during any consecutive twelve month period exceeds $115.0 million and (c) $45.0 million the first time net sales during any consecutive twelve month period exceeds $175.0 million. We recognized a gain of $14.4 million within Loss on Disposal of Assets, Net on our condensed consolidated statements of operations for the three and nine months ended September 30, 2020 related to this transaction. The gain recognized is net of transaction fees of $2.5 million and the carrying value of the Intrarosa assets and other costs of $4.0 million.

As part of the transaction with Millicent, we assigned both the Endoceutics License Agreement and the Endoceutics Supply Agreement to Millicent, and we agreed to provide certain transitional services to Millicent for a period of time following the closing pursuant to a transition services agreement.

Palatin

In January 2017, we entered into a license agreement with Palatin Technologies, Inc. (“Palatin”) under which we acquired (a) an exclusive license in all countries of North America (the “AMAG Territory”), with the right to grant sub-licenses, to research, develop and commercialize the Vyleesi Products, (b) a worldwide non-exclusive license, with the right to grant sub-licenses, to manufacture the Vyleesi Products, and (c) a non-exclusive license in all countries outside the AMAG Territory, with the right to grant sub-licenses, to research and develop (but not commercialize) the Vyleesi Products (the “Palatin License Agreement”). The transaction closed in February 2017 and was accounted for as an asset acquisition under ASU 2017-01.

In July 2020, we entered into a termination agreement with Palatin detailing the terms and conditions for the termination of the Company’s rights and obligations to develop and commercialize Vyleesi under the Palatin License Agreement and for the transfer of full ownership of Vyleesi to Palatin (the “Termination Agreement”). In accordance with the terms of the Termination Agreement, we transferred and assigned to Palatin the regulatory approval for Vyleesi, inventory, certain third party contracts, intellectual property rights and regulatory files and commercial materials of AMAG related to Vyleesi in the AMAG Territory. In consideration for the early termination of the License Agreement, the assumption of certain liabilities by Palatin (including significant minimum purchase obligations), and in lieu of any future milestone payments, royalties and other payments by AMAG to Palatin contemplated by the Palatin License Agreement, we paid Palatin $12.0 million following the termination, and we will pay an additional $4.3 million on March 31, 2021. We recognized a loss of $22.4 million in Loss on Disposal of Assets, net on our condensed consolidated statements of operations for the three and nine months ended September 30, 2020 related to this transaction. The loss recognized includes the carrying value of the Vyleesi assets and other costs, totaling $6.1 million in the aggregate. In addition, we agreed to provide certain transitional services to Palatin for a period of time following the closing pursuant to a transition services agreement.

P.     DEBT

Our outstanding debt obligations as of September 30, 2020 and December 31, 2019 consisted of the following (in thousands):

	September 30, 2020		December 31, 2019
2022 Convertible Notes	$	289,334	$	277,034
Total long-term debt	289,334		277,034
Less: current maturities	—		—
Long-term debt, net of current maturities	$	289,334	$	277,034

Convertible Notes

The outstanding balance of our 2022 Convertible Notes as of September 30, 2020 consisted of the following (in thousands):

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	2022 Convertible Notes
Liability component:
Principal	$	320,000
Less: debt discount and issuance costs, net	30,666
Net carrying amount	$	289,334
Gross equity component	$	72,576

In accordance with accounting guidance for debt with conversion and other options, we separately account for the liability and equity components of our 2022 Convertible Notes by allocating the proceeds between the liability component and the embedded conversion option (the “Equity Component”) due to our ability to settle the 2022 Convertible Notes in cash, common stock or a combination of cash and common stock, at our option. The carrying amount of the liability component was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The allocation was performed in a manner that reflected our non-convertible debt borrowing rate for similar debt. The Equity Component of the 2022 Convertible Notes was recognized as a debt discount and represents the difference between the proceeds from the issuance of the 2022 Convertible Notes and the fair value of the liability of the 2022 Convertible Notes on the date of issuance. The excess of the principal amount of the liability component over its carrying amount is amortized to interest expense using the effective interest method over five years. The Equity Component is not remeasured as long as it continues to meet the conditions for equity classification.

2022 Convertible Notes

In the second quarter of 2017, we issued $320.0 million aggregate principal amount of convertible senior notes due in 2022 (the “2022 Convertible Notes”) and received net proceeds of $310.4 million from the sale of the 2022 Convertible Notes, after deducting fees and expenses of $9.6 million. The approximate $9.6 million of debt issuance costs primarily consisted of underwriting, legal and other professional fees, and we allocated these costs to the liability and equity components based on the allocation of the proceeds. Of the total $9.6 million of debt issuance costs, $2.2 million was allocated to the Equity Component and recorded as a reduction to additional paid-in capital and $7.4 million was allocated to the liability component and is now recorded as a reduction of the 2022 Convertible Notes on our condensed consolidated balance sheets. The portion allocated to the liability component is amortized to interest expense using the effective interest method over five years.

The 2022 Convertible Notes are governed by the terms of an indenture between us, as issuer, and Wilmington Trust, National Association, as the trustee. The 2022 Convertible Notes are senior unsecured obligations and bear interest at a rate of 3.25% per year, payable semi-annually in arrears on June 1 and December 1 of each year, beginning on December 1, 2017. The 2022 Convertible Notes will mature on June 1, 2022, unless earlier repurchased or converted. Upon conversion of the 2022 Convertible Notes, such 2022 Convertible Notes will be convertible into, at our election, cash, shares of our common stock, or a combination thereof, at a conversion rate of 36.5464 shares of common stock per $1,000 principal amount of the 2022 Convertible Notes, which corresponds to an initial conversion price of approximately $27.36 per share of our common stock.

The conversion rate is subject to adjustment from time to time upon the occurrence of certain events, including, but not limited to, the issuance of stock dividends and payment of cash dividends. At any time prior to the close of business on the business day immediately preceding March 1, 2022, holders may convert their 2022 Convertible Notes at their option only under the following circumstances:

1)during any calendar quarter (and only during such calendar quarter), if the last reported sale price of our common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day;

2)during the five business day period after any five consecutive trading day period (the “measurement period”) in which the trading price per $1,000 principal amount of the 2022 Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of our common stock and the conversion rate on each such trading day; or

3)upon the occurrence of specified corporate events.

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On or after March 1, 2022, until the close of business on the business day immediately preceding the maturity date, holders may convert all or any portion of their 2022 Convertible Notes, in multiples of $1,000 principal amount, at the option of the holder regardless of the foregoing circumstances. The 2022 Convertible Notes were not convertible as of September 30, 2020.

We determined the expected life of the debt was equal to the five-year term on the 2022 Convertible Notes. The effective interest rate on the liability component was 9.49% for the period from the date of issuance through September 30, 2020. As of September 30, 2020, the “if-converted value” did not exceed the remaining principal amount of the 2022 Convertible Notes.

2019 Convertible Notes

In February 2014, we issued $200.0 million aggregate principal amount of the 2019 Convertible Notes. During 2017, we entered into privately negotiated transactions with certain investors to repurchase approximately $178.5 million aggregate principal amount of the 2019 Convertible Notes for an aggregate repurchase price of approximately $192.7 million, including accrued interest. The remaining $21.4 million of 2019 Convertible Notes matured on February 15, 2019 and were settled with cash.

Convertible Notes Interest Expense

The following table sets forth total interest expense recognized related to the Convertible Notes during the three and nine months ended September 30, 2020 and 2019 (in thousands):

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Contractual interest expense	$	2,600	$	2,600	$	7,800	$	7,867
Amortization of debt issuance costs	388		353		1,137		1,051
Amortization of debt discount	3,810		3,466		11,164		10,281
Total interest expense	$	6,798	$	6,419	$	20,101	$	19,199

Future Payments

Future annual principal payments on our long-term debt as of September 30, 2020 include $320.0 million due during the year ending December 31, 2022.

Q.     RESTRUCTURING EXPENSES

In May 2020, we completed a restructuring to reduce the size of our organization in conjunction with the planned divestiture of Intrarosa and Vyleesi and expected declines in our revenue due to the COVID-19 pandemic. Approximately 110 employees were displaced through this workforce reduction. We recorded a one-time restructuring charge of $8.2 million primarily related to severance and related benefits on our condensed consolidated statement of operations during the second quarter of 2020 and expect the restructuring charges incurred to date under this program to be substantially paid in cash by the end of the second quarter of 2021.

In February 2019, we completed a restructuring to combine our women’s health and maternal health sales forces into one integrated sales team, which promotes Intrarosa, the Makena auto-injector and Vyleesi. Approximately 110 employees were displaced through this workforce reduction. We recorded one-time restructuring charges of $7.4 million primarily related to severance and related benefits on our condensed consolidated statement of operations during the first quarter of 2019. The remaining accrued restructuring charges incurred under this program will be paid in cash by the end of the first quarter of 2021.

The following table displays charges taken related to the restructuring during the nine months ended September 30, 2020 (in thousands):

2020 Restructuring charges:
Workforce reduction	$	8,090
Other	107
Total 2020 restructuring charges	$	8,197

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The following table displays a rollforward of the changes to the accrued balances as of September 30, 2020 (in thousands): 

	2019 Restructuring		2020 Restructuring		Total
Balance accrued at December 31, 2019	$	797	$	—	$	797
2020 Restructuring Charges	—		8,197		8,197
Workforce Reduction Payments	(626)		(6,665)		(7,291)
Other Payments	—		(107)		(107)
Balance accrued at September 30, 2020	$	171	$	1,425	$	1,596

R.     REVISION OF PRIOR PERIOD FINANCIAL STATEMENTS

Prior period amounts, specifically net product sales and accrued expenses have been revised to correct prior period errors related to gross-to-net (“GTN”) adjustments for governmental rebates and the related accrual for certain state programs.

During the third quarter of 2020, in conjunction with our remediation efforts related to the errors identified during the second quarter of 2020 described below, we identified certain individually immaterial errors aggregating to $5.2 million related to governmental rebate accruals associated with Makena sales during the first and second quarters of 2020. We understated our GTN adjustments for governmental rebates and the related accrual for certain state programs by $2.8 million for the quarter ended March 31, 2020 and $2.8 million for the quarter ended June 30, 2020. This understatement also resulted in an overstatement of our related royalty obligation of $0.2 million for the quarter ended March 31, 2020 and $0.2 million for the quarter ended June 30, 2020. During the third quarter of 2020, we concluded that the errors were not material to any prior interim periods. However, we determined that correcting the aggregate error during the third quarter of 2020 would be material to the three-month period ended September 30, 2020. As a result, we have revised our historical financial statements to properly reflect the GTN adjustments and related royalty impact and accrual in the appropriate periods through an immaterial correction.

The effect of the correction to our condensed consolidated statement of stockholders’ equity is as follows:

	June 30, 2020
	As reported		Adjustment		As adjusted
Accumulated deficit	$	(1,051,153)	$	(5,216)	$	(1,056,369)
Total stockholders' equity	$	249,322	$	(5,216)	$	244,106

As previously reported, subsequent to the issuance of our Form 10-Q for the quarter ended March 31, 2020, management identified certain individually immaterial errors aggregating to $6.3 million related to governmental rebate accruals associated with Makena sales from 2016 through the first quarter of 2020. From 2016 through 2019, we understated our GTN adjustments for governmental rebates and the related accrual for a certain state program by $6.3 million and for the quarter ended March 31, 2020, we overstated these amounts by $1.8 million. As previously reported, we concluded that the errors were not material to any prior annual or interim period; however, we determined that correcting the aggregate error during the second quarter of 2020 would be material to the three-month period ended June 30, 2020. As a result, we have revised our historical financial statements to properly reflect GTN adjustments and the related accrual in the appropriate periods.

The effect of the corrections to our condensed consolidated statements of operations for the three and nine months ended September 30, 2019 are as follows (in thousands, except per share amounts):

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	Three Months Ended September 30, 2019						Nine Months Ended September 30, 2019
	As reported		Adj		As adjusted		As reported		Adj		As adjusted
Product sales, net	$	84,107	$	(323)	$	83,784	$	237,812	$	(981)	$	236,831
Total revenues	84,131		(323)		83,808		238,043		(981)		237,062
Net loss	$	(23,617)	$	(323)	$	(23,940)	$	(266,528)	$	(981)	$	(267,509)
Basic and diluted net loss per share	$	(0.70)	$	(0.01)	$	(0.71)	$	(7.83)	$	(0.02)	$	(7.85)

The condensed consolidated statements of other comprehensive loss for the three and nine months ended September 30, 2019 have been revised to include the changes to “net loss” summarized above.

The condensed consolidated statement of stockholders’ equity for the three months ended September 30, 2020 has been revised to reflect an increase of $5.2 million to the beginning “accumulated deficit” as of July 1, 2020, representing the accumulated error through that date. The condensed consolidated statements of stockholders’ equity for the three and nine months ended September 30, 2019 have been revised to include the changes to “net loss” summarized above as well as an increase of $5.1 million to the beginning “accumulated deficit” as of January 1, 2019, representing the accumulated error through that date.

The impact on our condensed consolidated statements of cash flows for the nine months ended September 30, 2019, was limited to the offsetting correction between “net loss” and changes in “accounts payable and accrued expenses” presented within “net cash used in operating activities”, as summarized in the above tables.

Refer to Amendment No. 1 on Form 10-K/A to our Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on September 15, 2020 for the impact on periods reported in the Company’s 2019 Annual Report on Form 10-K filed with the SEC on March 6, 2020 and for the impact on our condensed consolidated statement of operations for the impacted periods.

S.     RECENTLY ISSUED AND PROPOSED ACCOUNTING PRONOUNCEMENTS

From time to time, new accounting pronouncements are issued by FASB or other standard setting bodies that are adopted by us as of the specified effective date.

In August 2020, the FASB issued ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”). This standard simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts in an entity’s own equity. ASU 2020-06 is effective for annual reporting periods beginning after December 15, 2021 and interim periods within those annual periods. Early adoption is permitted but no earlier than annual reporting periods beginning after December 15, 2020 and interim periods within those annual periods. We are currently evaluating the impact of adoption of ASU 2020-06 on our condensed consolidated financial statements.

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T.     SUBSEQUENT EVENTS

Agreement and Plan of Merger

On October 1, 2020, we entered into the Merger Agreement with Covis and Merger Sub, pursuant to which Merger Sub has launched the Offer. The Merger Agreement has been unanimously approved by the boards of directors of AMAG and Covis. The Offer commenced on October 15, 2020 and will remain open for a minimum of 20 business days. The completion of the Offer is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of AMAG’s common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (which condition was satisfied on October 23, 2020), and other customary conditions. Upon the completion of the Offer, Merger Sub will merge with and into AMAG, with AMAG continuing as the surviving corporation (the “Merger”) and any outstanding shares of common that were not tendered in the Offer (or owned by Covis) will be automatically cancelled and converted into the right to receive an amount in cash equal to $13.75 per share, without interest. In addition, immediately prior to, and contingent upon, the closing of the Merger, each outstanding AMAG in-the-money stock option and restricted stock unit, whether vested or unvested, will be cancelled and automatically converted into the right to receive a cash payment in accordance with the terms of the Merger Agreement. The Offer and Merger are not subject to a financing condition.

The Merger Agreement contains customary representations, warranties and covenants, including covenants obligating AMAG to continue to conduct its business in the ordinary course, to cooperate in seeking regulatory approvals and not to engage in certain specified transactions or activities without Covis’s prior consent. The Merger Agreement also contains certain termination rights for each of AMAG and Covis, including the right to terminate the agreement if the Offer has not been consummated by January 28, 2021 or if the other party has materially breached and not cured any representation, warranty or covenant in the Merger Agreement. If we terminate the Merger Agreement under certain specified circumstances, we would be required to pay Covis a termination fee of $16.25 million.

Securities Litigation

In connection with the proposed Merger with Covis, seven complaints have been filed against the Company and its directors and certain officers, one of which also names Covis and certain of its affiliates as defendants. The complaints contain substantially similar allegations and generally allege that the Company’s solicitation/recommendation statement filed with the SEC on October 15, 2020 misrepresents and/or omits certain purportedly material information relating to financial projections and the analysis performed by the Company’s financial advisor in connection with the transaction and therefore violated Sections 14(e), 14(d)(4) and 20(a) of the Securities Exchange Act of 1934. The complaints seek, among other things, an injunction enjoining the consummation of the proposed transaction (or, if consummated, rescinding the transaction or awarding rescissory damages), costs related to the actions, including plaintiff’s attorneys’ fees and experts’ fees, declaratory relief, and any other relief the court may deem just and proper. In addition, one complaint also asserts that the directors breached their fiduciary duty of candor/disclosure by omitting purportedly material information from the solicitation/recommendation statement. We are currently unable to predict the outcome or reasonably estimate the range of potential loss associated with these claims, if any. It is possible that additional similar cases may also be filed in connection with the Merger.

FDA’s Proposal Regarding Makena

On October 5, 2020, we received a notice from the Center for Drug Evaluation and Research of the Food and Drug Administration (“FDA”) that the FDA is proposing to withdraw approval of Makena and that AMAG has the opportunity to request a hearing on the withdrawal. On October 14, 2020, we filed a request for a hearing with the FDA, together with an extension request for providing the supplemental information in support of our request for a hearing. On October 22, 2020, the FDA agreed to an extension and we plan to submit to the FDA by December 4, 2020 data, information, and analyses to demonstrate that there is a genuine and substantial issue of material fact that requires a hearing.

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

The following information should be read in conjunction with the unaudited financial information and the notes thereto included in this Quarterly Report on Form 10-Q and the audited financial information and the notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2019, as amended (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 terminology such as “may,” “will,” “could,” “should,” “would,” “expect,” “anticipate,” “continue,” “believe,” “plan,” “estimate,” “intend” or other similar words and 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, without limitation, statements regarding the following:

•expectations regarding our recently announced merger transaction with Covis, including the timing for such transaction;

•our plans regarding our business and our portfolio and the impact on our organization from the completion of the divestiture of our women’s health business;

•beliefs regarding the expenses, challenges and timing of our preclinical studies and clinical trials, including expectations regarding the clinical trial timing for and results of ciraparantag;

•beliefs regarding our commercial strategies and efforts;

•our estimates and beliefs regarding the market opportunities for each of our products and product candidates;

•beliefs about and expectations for our commercialization, marketing and manufacturing of our products and product candidates, if approved, (which may be conducted by third parties);

•expectations related to potential FDA regulatory actions for Makena following the October 2019 meeting of its Advisory Committee and beliefs and expectations regarding our interactions with the FDA, including our hearing request;

•beliefs and expectations about our cash flows and liquidity and capital resources;

•beliefs about health care provider behaviors and reactions;

•plans to work with the FDA and beliefs that there may be a path forward for continued commercialization of Makena;

•expectations and plans with respect to litigation matters and contract disputes, including the merits thereof;

•the timing and amounts of milestone and royalty payments;

•expectations and plans as to recent and upcoming regulatory and commercial developments and activities, including requirements, initiatives and timelines for clinical trials and post-approval commitments for our products and product candidates, and their impact on our business and competition;

•expectations for our intellectual property rights covering our product candidates and technology and the impact of generics and other competition could have on each of our products and our business generally, including the timing and number of generic entrants;

•developments relating to our competitors and our industry, including the impact of government regulation;

•expectations regarding third-party reimbursement and the behaviors of payers, healthcare providers, patients and other industry participants, including with respect to product price increases and volume-based and other rebates and incentives;

•expectations regarding the contribution of revenues from our products to the funding of our on-going operations and costs to be incurred in connection with revenue sources to fund our future operations;

•expectations regarding customer returns and other revenue-related reserves and accruals;

•beliefs about our internal controls and procedures and remediation efforts of our identified material weakness;

•expectations as to the manufacture of drug substances and drug products and key materials for our products and product candidates;

•expectations as to our effective tax rate and our ability to realize our net operating loss carryforwards and other tax attributes;

•the impact of accounting pronouncements;

•expectations regarding our financial performance and our ability to implement our strategic plans for our business;

•estimates and beliefs related to our 2022 Convertible Notes and the manner in which we intend or are required to settle the 2022 Convertible Notes, including upon consummation of the transactions with Covis;

•estimates, beliefs and judgments related to the valuation of certain intangible assets, goodwill, contingent consideration, debt and other assets and liabilities, including our impairment analysis and our methodology and assumptions regarding fair value measurements;

•beliefs regarding the impact of our May 2020 and February 2019 restructuring initiatives; and

•the impact of the COVID-19 pandemic on the above.

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 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.

AMAG Pharmaceuticals®, the logo and designs and Feraheme® are registered trademarks of AMAG Pharmaceuticals, Inc. Makena® is a registered trademark of AMAG Pharma USA, Inc. Intrarosa® is a registered trademark of Endoceutics, Inc. Other trademarks referenced in this report are the property of their respective owners.

Overview

AMAG Pharmaceuticals, Inc., a Delaware corporation, was founded in 1981. We are a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs by leveraging our development and commercial expertise to invest in and grow our pharmaceutical products and product candidates across a range of therapeutic areas. Our currently marketed products support the health of patients in the areas of hematology and maternal and women’s health, including Feraheme® (ferumoxytol injection) for intravenous use and Makena® (hydroxyprogesterone caproate injection) auto-injector. In addition to our approved products, our portfolio includes one product candidate, ciraparantag, which is being studied as an anticoagulant reversal agent.

On October 1, 2020, we entered into an Agreement and Plan of Merger with Covis Group S.à r.l., a Luxembourg company (“Covis”), Covis Mergerco Inc., a Delaware corporation and an indirect wholly owned subsidiary of Covis (“Merger Sub”), and (in respect of specific matters) Covis Finco S.à r.l., a Luxembourg company, pursuant to which Merger Sub will conduct a cash tender offer (the “Offer”) to acquire all of the issued and outstanding shares of common stock of AMAG at a price per share of $13.75, net to the seller in cash, without interest. The Offer commenced on October 15, 2020 and will remain open for a minimum of 20 business days. The completion of the Offer is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of AMAG’s common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (which condition was satisfied on October 23, 2020), and other customary conditions. For additional information, refer to Note T, “Subsequent Events,” to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

As previously disclosed, in July 2020, we entered into a termination agreement with Palatin Technologies, Inc. (“Palatin”), pursuant to which we terminated the License Agreement with Palatin, dated January 8, 2017 (the “Palatin License Agreement”), and our rights and obligations to develop and commercialize Vyleesi thereunder, were terminated. In addition, we transferred all rights in and to and full ownership of Vyleesi, including the regulatory approval of Vyleesi, to Palatin. Refer to Note O, “Acquisitions, Collaboration, License and Other Strategic Agreements,” to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for additional detail.

Additionally, as previously disclosed, we decided to stop the AMAG-423 Phase 2b/3a study in July 2020 based, primarily, on the results of an interim analysis conducted by the study’s independent Data Safety Monitoring Board (“DSMB”). In connection therewith, we terminated our supply agreement (including considerable minimum purchase obligations) with Protherics UK Ltd, a subsidiary of BTG plc (“BTG”) in August 2020, in exchange for a one-time payment by us of $12.5 million and our grant to BTG of a 9-month option (subject to extension under certain situations) to acquire the AMAG 423 program rights and assume our related obligations, including our obligations under the option agreement with Velo Bio, LLC, as further described in Note O, “Acquisitions, Collaboration, License and Other Strategic Agreements” ito our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

Our primary sources of revenue are currently from sales of Feraheme and the Makena auto-injector.

AMAG’s Portfolio of Products and Product Candidates

Feraheme

Feraheme received approval from the U.S. Food and Drug Administration (the “FDA”) in June 2009 for use as an IV iron replacement therapy for the treatment of iron deficiency anemia (“IDA”) in adult patients with chronic kidney disease (“CKD”). In February 2018, the FDA approved the supplemental New Drug Application to expand the Feraheme label to include all eligible adult IDA patients who have intolerance to oral iron or have had unsatisfactory response to oral iron in addition to patients who have CKD. IDA is prevalent in many different patient populations, such as patients with CKD, gastrointestinal

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diseases or disorders, inflammatory diseases and chemotherapy-induced anemia. For many of these patients, treatment with oral iron is unsatisfactory or is not tolerated. It is estimated that approximately five million people in the U.S. have IDA and we estimate that a small fraction of the patients who are diagnosed with IDA regardless of the underlying cause are currently being treated with IV iron.

The expanded Feraheme label was supported by two positive pivotal Phase 3 trials, which evaluated Feraheme versus iron sucrose or placebo in a broad population of patients with IDA and positive results from a third Phase 3 randomized, double-blind non-inferiority trial that evaluated the incidence of moderate-to-severe hypersensitivity reactions (including anaphylaxis) and moderate-to-severe hypotension with Feraheme compared to Injectafer® (ferric carboxymaltose injection) (the “Feraheme comparator trial”). The Feraheme comparator trial demonstrated comparability to Injectafer® based on the primary composite endpoint of the incidence of moderate-to-severe hypersensitivity reactions (including anaphylaxis) and moderate-to-severe hypotension (Feraheme incidence 0.6%; Injectafer® incidence 0.7%). Adverse event rates were similar across both treatment groups; however, the incidence of severe hypophosphatemia (defined by blood phosphorous of <0.2 mg/dl at week 2) was less in the patients receiving Feraheme (0.4% of patients) compared to those receiving Injectafer® (38.7% of patients).

Makena

Makena is indicated to reduce the risk of preterm birth in women pregnant with a single baby who have a history of singleton spontaneous preterm birth. We acquired the rights to Makena in connection with our acquisition of Lumara Health Inc. (“Lumara Health”) in November 2014.

Makena was approved by the FDA in February 2011 as an intramuscular (“IM”) injection (the “Makena IM product”) packaged in a multi-dose vial and in February 2016 as a single-dose preservative-free vial. In February 2018, the Makena auto-injector was approved by the FDA for administration via a pre-filled subcutaneous auto-injector, a drug-device combination product (the “Makena auto-injector”).

In March 2019, we announced topline results from the Progestin’s Role in Optimizing Neonatal Gestation clinical trial (“PROLONG Trial”), a randomized, double-blinded, placebo-controlled clinical trial evaluating Makena in patients with a history of a prior spontaneous singleton preterm delivery. The PROLONG Trial was conducted under the FDA’s “Subpart H” accelerated approval process and, in October 2019, we announced that full results of the PROLONG Trial were published online in the American Journal of Perinatology. The PROLONG Trial, in contrast to a previously conducted Phase 3 trial (the Meis trial) on which Makena’s approval was primarily based, did not demonstrate a statistically significant difference between the treatment and placebo arms for the co-primary endpoints. The adverse event profile between the two arms was comparable. On October 29, 2019, the Bone, Reproductive and Urologic Drugs Advisory Committee (the “Advisory Committee”) met to discuss the results of the PROLONG Trial to inform the FDA’s regulatory decision for Makena and voted, among other things, nine to seven that the FDA should pursue withdrawal of approval for Makena.

In the first quarter of 2020 in response to our request to the FDA for a meeting to discuss the clinical benefit of the product, the FDA indicated that it was premature to meet at that time as it was still reviewing the matter, and, in July 2020, the FDA indicated that they were still reviewing information pertinent to Makena. In anticipation of further discussion with the FDA, we proactively initiated the first part of a retrospective study. On October 5, 2020, we received a notice from the Center for Drug Evaluation and Research of the FDA (“CDER”) that the FDA is proposing to withdraw approval of Makena and that we have the opportunity to request a hearing on the withdrawal. On October 14, 2020, we filed a request for a hearing with the FDA on the proposal to withdraw approval of Makena, together with an extension request for providing the supplemental information in support of our request for a hearing. On October 22, 2020, the FDA agreed to an extension and we plan to submit to the FDA by December 4, 2020 data, information, and analyses to demonstrate that there is a genuine and substantial issue of material fact that requires a hearing. If the FDA grants our request for a hearing, it would conduct such hearing and thereafter decide whether to withdraw approval of Makena. In the frequently asked questions referred to in CDER’s statement published on October 5, 2020, the FDA indicated this process can take months. During the pendency of this process, the Makena label remains unchanged and Makena and the approved generic formulations of Makena will remain on the market until the FDA makes a final decision about these products.

This complex and unique situation has no clear precedent and it is therefore difficult to predict the outcome or timing of any hearing, if granted, by the FDA. We remain committed to working collaboratively with the FDA to seek a path forward to ensure eligible pregnant women continue to have access to Makena and the currently approved generics that rely on Makena as an innovator drug.

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Ciraparantag

In January 2019, we acquired ciraparantag with our acquisition of Perosphere Pharmaceuticals Inc. (“Perosphere”), a privately-held biopharmaceutical company pursuant to an Agreement and Plan of Merger (the “Perosphere Agreement”). Ciraparantag is a small molecule anticoagulant reversal agent in development as a single dose solution that is delivered intravenously to reverse the effects of certain direct oral anticoagulants (“DOACs”) (Xarelto®(rivaroxaban), Eliquis®(apixaban), and Savaysa®(edoxaban) as well as Lovenox® (enoxaparin sodium injection), a low molecular weight heparin when reversal of the anticoagulant effect of these products is needed for emergency surgery, urgent procedures or due to life-threatening or uncontrolled bleeding. Ciraparantag has been granted Fast Track designation by the FDA.

Ciraparantag has been evaluated in more than 250 healthy volunteers across seven clinical trials. A first in human Phase 1 study evaluated the safety, tolerability, pharmacokinetic, and pharmacodynamic effects of ciraparantag alone and following a single dose of Savaysa®, and another Phase 1 study evaluated the overall metabolism of the drug. Two Phase 2a studies evaluated the safety, tolerability, pharmacokinetic, and pharmacodynamic effects related to the reversal of unfractionated heparin and Lovenox® and three Phase 2b randomized, single-blind, placebo-controlled dose-ranging studies evaluated the reversal of Savaysa®, Eliquis®, and Xarelto® to assess the safety and efficacy of ciraparantag, each of which included 12 subjects dosed with ciraparantag. In these Phase 2b clinical trials, ciraparantag or placebo was administered to healthy volunteers in a blinded fashion after achieving steady blood concentrations of the respective anticoagulant. Pharmacodynamic assessments of whole blood clotting time (“WBCT”), an important laboratory measure of clotting capacity, were sampled frequently for the first hour post study drug dose, and then periodically thereafter out to 24 hours post administration of study drug. Key endpoints in the Phase 2 trials included mean change from baseline in WBCT and the proportion of subjects that returned to within 10% of their baseline WBCT. Subjects in these studies experienced a rapid and statistically significant (p<0.001) reduction in WBCT compared to placebo as early as 15 minutes after the administration of ciraparantag in each of the four studies and the effect was sustained for 24 hours. Moreover, in both the Eliquis® and Xarelto® studies, 100% of subjects in the highest dose cohorts (180 mg of ciraparantag) were responders, as defined by a return to within 10% of baseline WBCT within 30 minutes and sustained for at least six hours. Ciraparantag has been well tolerated in clinical trials, with the most common related adverse events to date being mild sensations of coolness, warmth or tingling, skin flushing, and alterations in taste. There have been no drug-related serious adverse events to date.

We are planning to conduct Phase 2b clinical studies in healthy volunteers to confirm the proposed dose of ciraparantag to be used in the Phase 3 program, after reaching peak steady state blood concentrations of certain DOAC drugs. The Phase 2b studies will utilize an automated coagulometer developed by Perosphere Technologies, Inc. (“Perosphere Technologies”), an independent company, to measure WBCT and, based on feedback from the FDA, we will also measure WBCT manually. An investigational device exemption, which Perosphere Technologies submitted in October 2020, is required for use of the coagulometer in clinical studies. Due to the impact of the COVID-19 pandemic and the additional requirement of manual WBCT testing, the Phase 2b study initiation has been delayed, may continue to be delayed and may take longer than anticipated. Furthermore, even once we can proceed with initiation of the trial and begin enrollment, COVID-19 might present further challenges if study candidates are hesitant to enroll and increase their inter-personal exposure because of concerns over the contagiousness of COVID-19 or if additional screening criteria is needed. We are therefore unable to estimate when the study might be completed.

In July 2020, we entered into a License and Commercialization Agreement with Norgine B.V. (“Norgine” and such agreement, the “Norgine Agreement”), pursuant to which we granted Norgine an exclusive license to develop and commercialize ciraparantag in certain countries in Europe, Australia and New Zealand. For additional details regarding the Norgine Agreement, see Note O, “Acquisitions, Collaboration, License and other Strategic Agreements,” to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

Impact of COVID-19 on our business

We continue to evaluate the impact of COVID-19 on patients, healthcare providers and our employees, as well as on our operations and the operations of our business partners and healthcare communities. Given the importance of supporting our patients, we are diligently working with our suppliers, healthcare providers and partners to provide patients with access to Feraheme and Makena while taking into account regulatory, institutional, and government guidance, policies and protocols. To date, COVID-19 protocols have restricted or discouraged patient access to hospitals, clinics, physicians’ offices and other sites where Feraheme and Makena are typically administered and caused a re-prioritization of healthcare services. Although we saw an improvement in volume and corresponding increase in our net product sales and financial results during the three months ended September 30, 2020, the future impact of the COVID-19 pandemic on our net product sales is uncertain. If the COVID-19 situation worsens and disruptions continue, it may result in an adverse impact to our financial performance for 2020. We are currently working to initiate our planned ciraparantag Phase 2b trial that was delayed as a result of COVID-19, and we are working with our CROs to understand the duration and scope of disruptions at clinical trial sites and on anticipated

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enrollment for our planned ciraparantag Phase 2b trial. To date, we and our suppliers have been able to continue to supply our products and our product candidates, and currently do not anticipate any interruptions in supply. Given the uncertainties regarding the duration and scope of the COVID-19 pandemic, the full impacts on our sales, supply, research and development efforts and operations are currently unknown, but will likely continue to impact our performance in 2020 and could continue to represent a risk to our future performance. We are actively monitoring the situation and may take precautionary and preemptive actions that we determine are in the best interests of our business. We cannot predict the effects that such actions may have on our business or on our financial results, in particular with respect to demand for or access to our products. Please refer to our Risk Factors in Part II, Item IA of this Quarterly Report on Form 10-Q for further discussion of COVID-19 risks.

Critical Accounting Policies

Our management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. 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

liabilities. Actual results could differ materially from those estimates. Management employs the following critical accounting

policies affecting our most significant estimates and assumptions: revenue recognition and related sales allowances and

accruals; valuation of marketable securities; valuation of inventory; business combinations and asset acquisitions, including acquisition-related contingent consideration; goodwill; intangible assets; equity-based compensation; and income taxes.

There have been no significant changes to our critical accounting policies and estimates during the nine months ended September 30, 2020, compared to the critical accounting policies and estimates disclosed in Part II, Item 7, of our Annual Report.

Results of Operations - Three Months Ended September 30, 2020 and 2019 

Revenues

Total net product sales for the three months ended September 30, 2020 and 2019 consisted of the following (in thousands except for percentages):

	Three Months Ended September 30,				2020 to 2019
	2020		2019		$ Change		% Change
Product sales, net
Feraheme	$	46,718	$	44,205	$	2,513	6	%
Makena	25,860		33,949		(8,089)		(24)	%
Intrarosa	37		5,607		(5,570)		(99)	%
Other	614		23		591		>100 %
Total product sales, net	73,229		83,784		(10,555)		(13)	%
Other revenues	19,877		24		19,853		>100 %
Total revenues	$	93,106	$	83,808	$	9,298	11	%

Our total net product sales for the three months ended September 30, 2020 decreased by $10.6 million as compared to the same period in 2019, due primarily to a decrease in Makena net sales. We believe that the decrease in Makena net sales during the quarter was primarily driven by concern amongst health care providers caused by the unfavorable FDA Advisory Committee recommendation for Makena during the fourth quarter of 2019. Intrarosa net sales also decreased during the three months ended September 30, 2020 as compared to the same period in 2019 as a result of the disposition of the product in May 2020.

In addition, in July 2020, we entered into a License and Commercialization Agreement with Norgine B.V. (“Norgine”, and such agreement, the “Norgine Agreement”), pursuant to which we granted Norgine an exclusive license to develop and commercialize ciraparantag in certain countries in Europe, Australia and New Zealand (the “Norgine territory”). We received a $30.0 million upfront payment upon signing. During the three months ended September 30, 2020, we recognized $19.8 million of collaboration revenue. Refer to Note C, “Revenue Recognition,” to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for further detail.

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Product Sales Allowances and Accruals

Total gross product sales were offset by product sales allowances and accruals for the three months ended September 30, 2020 and 2019 as follows (in thousands, except for percentages):

	Three Months Ended September 30,								2020 to 2019
	2020		Percent of gross product sales		2019		Percent of gross product sales		$ Change		% Change
Gross product sales	$	218,739			$	254,073			$	(35,334)	(14)	%
Provision for product sales allowances and accruals:
Contractual adjustments	129,966		59	%	144,108		57	%	(14,142)		(10)	%
Governmental rebates	15,544		7	%	26,181		10	%	(10,637)		(41)	%
Total	145,510		67	%	170,289		67	%	(24,779)		(15)	%
Product sales, net	$	73,229			$	83,784			$	(10,555)	(13)	%

The increase in contractual adjustments as a percentage of gross product sales primarily related to a higher mix of business through commercial reimbursement channels and additional discounts offered to commercial entities. The decrease in governmental rebates as a percentage of gross product sales primarily related to changes in estimates related to prior periods during the three months ended September 30, 2019.

We may refine our estimated revenue reserves as we continue to obtain additional experience or as our customer mix changes. If we determine in future periods that our actual experience is not indicative of our expectations, if our actual experience changes, or if other factors affect our estimates, we may be required to adjust our allowances and accruals estimates, which would affect our net product sales in the period of the adjustment and could be significant.

Costs and Expenses

Cost of Product Sales

Cost of product sales for the three months ended September 30, 2020 and 2019 were as follows (in thousands except for percentages):

	Three Months Ended September 30,						2020 to 2019
	2020			2019			$ Change		% Change
Direct cost of product sales	$	11,367		$	16,893		$	(5,526)	(33)	%
Amortization of intangible assets	1,973			4,212			(2,239)		(53)	%
	$	13,340		$	21,105		$	(7,765)	(37)	%
Direct cost of product sales as a percentage of net product sales	16		%	20		%

Direct cost of product sales as a percentage of net product sales decreased during the three months ended September 30, 2020 as compared to the three months ended September 30, 2019. The decrease was primarily driven by a shift in revenue mix from products with higher cost of product sales to products with lower cost of product sales. We expect direct cost of product sales as a percentage of net product sales to remain relatively consistent or increase slightly relative to the percentage at the end of the third quarter of 2020 for the remainder of 2020.

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Research and Development Expenses

Research and development expenses for the three months ended September 30, 2020 and 2019 consisted of the following (in thousands except for percentages):

	Three Months Ended September 30,				2020 to 2019
	2020		2019		$ Change		% Change
External research and development expenses	$	3,681	$	9,398	$	(5,717)	(61)	%
Internal research and development expenses	3,434		5,932		(2,498)		(42)	%
Total research and development expenses	$	7,115	$	15,330	$	(8,215)	(54)	%

The $8.2 million decrease in research and development expenses incurred in the three months ended September 30, 2020, as compared to the three months ended September 30, 2019, was primarily related to the cessation of the AMAG-423 Phase 2b/3a study and the divestiture of Vyleesi during the third quarter of 2020 as well as lower internal costs as a result of the workforce reduction in May 2020.

Although the potential impacts of the COVID-19 pandemic are evolving daily and cannot be predicted, we expect our external research and development expenses to increase during the fourth quarter of 2020 as compared to the third quarter of 2020. This expectation is dependent on the duration and extent of the impacts of COVID-19 on our ability to initiate our planned ciraparantag Phase 2b trial. Regardless of the COVID-19 pandemic, we cannot determine with certainty the duration and completion costs of our current or future clinical trials of our products or product candidate as the duration, costs and timing of clinical trials depends on a variety of factors including the uncertainties of future clinical and preclinical studies, uncertainties in clinical trial enrollment rates and significant and changing government regulation.

Selling, General and Administrative Expenses

Selling, general and administrative expenses for the three months ended September 30, 2020 and 2019 consisted of the following (in thousands except for percentages):

	Three Months Ended September 30,				2020 to 2019
	2020		2019		$ Change		% Change
Compensation, payroll taxes and benefits	$	17,141	$	26,018	$	(8,877)	(34)	%
Professional, consulting and other outside services	16,661		35,639		(18,978)		(53)	%
Fair value of contingent consideration liability	—		5		(5)		(100)	%
Equity-based compensation expense	1,854		4,058		(2,204)		(54)	%
Total selling, general and administrative expenses	$	35,656	$	65,720	$	(30,064)	(46)	%

Selling, general and administrative expenses decreased by $30.1 million in the three months ended September 30, 2020 as compared to the same period in 2019, primarily due to decreases in marketing spend related to our women’s health products and reduced compensation related costs as a result of our May 2020 restructuring.

We expect that total selling, general and administrative expenses for the fourth quarter of 2020 will be consistent with the third quarter of 2020.

Loss on Disposal of Assets

During the three months ended September 30, 2020, we recognized a loss on disposal of assets of $35.4 million primarily related to losses of $22.4 million and $12.5 million recognized in conjunction with the divestiture of Vyleesi and the cessation of the AMAG-423 Phase 2b/3a study, respectively.

Other Income (Expense), Net

Other income (expense), net for the three months ended September 30, 2020 increased by $13.4 million primarily due to a Confidential Settlement Agreement and Release with a third-party manufacturer to resolve outstanding disputes. Pursuant to this agreement, we were paid a sum of $17.4 million, and the parties exchanged mutual releases to resolve all disputes between them.

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Income Tax (Benefit) Expense

The following table summarizes our effective tax rate and income tax (benefit) expense for the three months ended September 30, 2020 and 2019 (in thousands except for percentages):

	Three Months Ended September 30,
	2020			2019
Effective tax rate	(1)		%	(1)		%
Income tax (benefit) expense	$	(53)		$	232

For the three months ended September 30, 2020, we recognized an immaterial income tax benefit, representing an effective tax rate of (1)%. The difference between the statutory federal tax rate of 21% and the (1)% effective tax rate for the three months ended September 30, 2020 was primarily attributable to the valuation allowance established against our current period losses generated. We have established a valuation allowance on our deferred tax assets to the extent that our existing taxable temporary differences would not be available as a source of income to realize the benefits of those deferred tax assets. The income tax benefit for the three months ended September 30, 2020 primarily related to state income taxes.

For the three months ended September 30, 2019, we recognized an immaterial income tax expense, representing an effective tax rate of (1)%. The difference between the statutory federal tax rate of 21% and the (1)% effective tax rate for the three months ended September 30, 2019, was primarily attributable to the valuation allowance established against our current period losses generated and the non-deductible IPR&D expense related to the Perosphere acquisition.

Results of Operations - Nine Months Ended September 30, 2020 and 2019 

Revenues

Total net product sales for the nine months ended September 30, 2020 and 2019 consisted of the following (in thousands except for percentages):

	Nine Months Ended September 30,				2020 to 2019
	2020		2019		$ Change		% Change
Product sales, net
Feraheme	$	120,786	$	126,294	$	(5,508)	(4)	%
Makena	66,079		95,483		(29,404)		(31)	%
Intrarosa	4,423		14,898		(10,475)		(70)	%
Other	(586)		156		(742)		<(100 %)
Total product sales, net	190,702		236,831		(46,129)		(19)	%
Other revenues	19,935		231		19,704		>100 %
Total revenues	$	210,637	$	237,062	$	(26,425)	(11)	%

Our total net product sales for the nine months ended September 30, 2020 decreased by $46.1 million as compared to the same period in 2019, due primarily to decreases in Makena, Feraheme and Intrarosa net sales. We believe that the decrease in Makena net sales during the period was primarily driven by concern amongst health care providers caused by the unfavorable FDA Advisory Committee recommendation for Makena during the fourth quarter of 2019. The decrease in Feraheme net sales was driven by the negative impacts of COVID-19 during the second quarter of 2020 as COVID-19 protocols had restricted or discouraged patient access to hospitals, clinics and other sites where Feraheme is typically administered. Intrarosa net sales decreased as a result of the disposition of the product in May 2020.

In addition, in July 2020, we entered into a License and Commercialization Agreement with Norgine B.V. (“Norgine”, and such agreement, the “Norgine Agreement”), pursuant to which we granted Norgine an exclusive license to develop and commercialize ciraparantag in certain countries in Europe, Australia and New Zealand (the “Norgine territory”). We received a $30.0 million upfront payment upon signing. During the nine months ended September 30, 2020, we recognized $19.8 million of collaboration revenue. Refer to Note C, “Revenue Recognition,” to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for further detail.

Total gross product sales were offset by product sales allowances and accruals for the nine months ended September 30, 2020 and 2019 as follows (in thousands, except for percentages):

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	Nine Months Ended September 30,								2020 to 2019
	2020		Percent of gross product sales		2019		Percent of gross product sales		$ Change		% Change
Gross product sales	$	633,475			$	704,976			$	(71,501)	(10)	%
Provision for product sales allowances and accruals:
Contractual adjustments	383,003		60	%	381,633		54	%	1,370		—	%
Governmental rebates	59,770		9	%	86,512		12	%	(26,742)		(31)	%
Total	442,773		70	%	468,145		66	%	(25,372)		(5)	%
Product sales, net	$	190,702			$	236,831			$	(46,129)	(19)	%

The increase in contractual adjustments as a percentage of gross product sales primarily related to a higher mix of business through commercial reimbursement channels and additional discounts offered to commercial entities. The decrease in governmental rebates as a percentage of gross product sales primarily related to changes in estimates related to prior periods during the nine months ended September 30, 2019.

Costs and Expenses

Cost of Product Sales

Cost of product sales for the nine months ended September 30, 2020 and 2019 were as follows (in thousands except for percentages):

	Nine Months Ended September 30,						2020 to 2019
	2020			2019			$ Change		% Change
Direct cost of product sales	$	34,655		$	51,774		$	(17,119)	(33)	%
Amortization of intangible assets	20,771			12,097			8,674		72	%
	$	55,426		$	63,871		$	(8,445)	(13)	%
Direct cost of product sales as a percentage of net product sales	18		%	22		%

Direct cost of product sales as a percentage of net product sales decreased from 22% to 18% during the first three quarters of 2020. Direct cost of product sales for the nine months ended September 30, 2019 included a $4.8 million one-time inventory write-down related to the Makena IM product. In addition to this one-time inventory write-down, direct cost of product sales as a percentage of net product sales decreased as a result of a shift in revenue mix from products with higher cost of product sales to products with lower cost of product sales during the first three quarters of 2020 as compared to the same period in 2019.

Amortization of intangible assets increased by $8.7 million for the nine months ended September 30, 2019 compared to the same period in September 30, 2020 due to accelerated amortization resulting from our reassessment and prospective adjustment of the useful lives of the Makena auto-injector developed technology, Intrarosa developed technology and Vyleesi developed technology intangible assets during the fourth quarter of 2019.

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Research and Development Expenses

Research and development expenses for the nine months ended September 30, 2020 and 2019 consisted of the following (in thousands except for percentages):

	Nine Months Ended September 30,				2020 to 2019
	2020		2019		$ Change		% Change
External research and development expenses	$	13,906	$	30,708	$	(16,802)	(55)	%
Internal research and development expenses	12,652		17,669		(5,017)		(28)	%
Total research and development expenses	$	26,558	$	48,377	$	(21,819)	(45)	%

The $21.8 million decrease in research and development expenses incurred in the nine months ended September 30, 2020 as compared to the same period in 2019 was primarily related to lower costs for Vyleesi following FDA approval in 2019, cessation of the AMAG-423 Phase 2b/3a study, and lower internal costs as a result of the workforce reduction in May 2020.

Acquired In-Process Research and Development

During the nine months ended September 30, 2019, we recorded $74.9 million for acquired IPR&D related to the acquisition of Perosphere.

Selling, General and Administrative Expenses

Selling, general and administrative expenses for the nine months ended September 30, 2020 and 2019 consisted of the following (in thousands except for percentages):

	Nine Months Ended September 30, 2020				2020 to 2019
	2020		2019		$ Change		% Change
Compensation, payroll taxes and benefits	$	68,584	$	83,150	$	(14,566)	(18)	%
Professional, consulting and other outside services	51,935		123,554		(71,619)		(58)	%
Fair value of contingent consideration liability	—		(16)		16		(100)	%
Equity-based compensation expense	7,403		11,039		(3,636)		(33)	%
Total selling, general and administrative expenses	$	127,922	$	217,727	$	(89,805)	(41)	%

Total selling, general and administrative expenses decreased by $89.8 million in the nine months ended September 30, 2020 as compared to the same period in 2019, primarily driven by decreases in marketing spend related to our women’s health products and reduced compensation related costs as a result of the May 2020 restructuring.

Impairment of Intangible Assets in 2019

During the nine months ended September 30, 2019, we discontinued the Makena IM products and recorded a $77.4 million impairment charge for the Makena base technology intangible asset, which related to the Makena IM products.

Loss on Disposal of Assets

During the nine months ended September 30, 2020, we recognized a loss on disposal of assets of $21.0 million, primarily related to losses of $22.4 million and $12.5 million recognized in conjunction with the divestiture of Vyleesi and the cessation of the AMAG-423 Phase 2b/3a study, respectively. These losses were offset by the gain of $14.4 million recognized on the sale of Intrarosa during the second quarter of 2020.

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Restructuring Expense

In May 2020, we completed a restructuring to reduce the size of our organization in conjunction with the divestiture of Intrarosa and Vyleesi and expected declines in our revenue due to the COVID-19 pandemic. Approximately 110 employees were displaced through this workforce reduction. We recorded a restructuring charge of $8.2 million primarily related to severance and related benefits in the second quarter of 2020 and expect the restructuring charges incurred to date under this program to be substantially paid in cash by the end of the second quarter of 2021. We estimate total savings from the restructuring in 2020 will be approximately $13.1 million.

In February 2019, we completed a restructuring to combine our women’s health and maternal health sales forces into one integrated sales team, which promoted Intrarosa, the Makena auto-injector and following approval, Vyleesi. Approximately 110 employees were displaced through this workforce reduction. We recorded a restructuring charge of $7.4 million primarily related to severance and related benefits in the first quarter of 2019. These restructuring charges were substantially paid in cash as of the end of the first quarter of 2020 and will be fully paid in cash by the end of the first quarter of 2021. For additional information on restructuring expenses, see Note Q, “Restructuring Expenses,” to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

Other Income (Expense), Net

Other income (expense), net for the nine months ended September 30, 2020 increased by $11.8 million primarily due to a Confidential Settlement Agreement and Release with a third-party manufacturer to resolve outstanding disputes. Pursuant to this agreement, we were paid a sum of $17.4 million, and the parties exchanged mutual releases to resolve all disputes between them.

Income Tax Benefit

The following table summarizes our effective tax rate and income tax benefit for the nine months ended September 30, 2020 and 2019 (in thousands except for percentages):

	Nine Months Ended September 30,
	2020			2019
Effective tax rate	—		%	—		%
Income tax benefit	$	(113)		$	(26)

For the nine months ended September 30, 2020, we recognized an immaterial income tax benefit representing an effective tax rate of 0%. The difference between the statutory federal tax rate of 21% and the 0% effective tax rate for the nine months ended September 30, 2020 was primarily attributable to the valuation allowance established against our current period losses generated. We have established a valuation allowance on our deferred tax assets to the extent that our existing taxable temporary differences would not be available as a source of income to realize the benefits of those deferred tax assets. The income tax benefit for the nine months ended September 30, 2020 primarily related to state income taxes.

For the nine months ended September 30, 2019, we recognized an immaterial income tax benefit, representing an effective tax rate of 0%. The difference between the statutory federal tax rate of 21% and the 0% effective tax rate for the nine months ended September 30, 2019, was primarily attributable to the valuation allowance established against our current period losses generated and the non-deductible IPR&D expense related to the Perosphere acquisition.

Liquidity and Capital Resources

General

We currently finance our operations primarily from cash generated from our operating activities, including sales of our commercialized products. Cash, cash equivalents, marketable securities and certain financial obligations as of September 30, 2020 and December 31, 2019 consisted of the following (in thousands except for percentages):

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	September 30, 2020		December 31, 2019		$ Change		% Change
Cash and cash equivalents	$	97,984	$	113,009	$	(15,025)	(13)	%
Marketable securities	70,917		58,742		12,175		21	%
Total	$	168,901	$	171,751	$	(2,850)	(2)	%
Outstanding principal on 2022 Convertible Notes	$	320,000	$	320,000	$	—	—	%
Total	$	320,000	$	320,000	$	—	—	%

Cash Flows

The following table presents a summary of the primary sources and uses of cash for the nine months ended September 30, 2020 and 2019 (in thousands):

	September 30, 2020		September 30, 2019		$ Change
Net cash used in operating activities	$	(6,763)	$	(105,731)	$	98,968
Net cash (used in) provided by investing activities	(7,643)		8,408		(16,051)
Net cash used in financing activities	(619)		(36,133)		35,514
Net decrease in cash, cash equivalents, and restricted cash	$	(15,025)	$	(133,456)	$	118,431

Operating Activities

Cash flows from operating activities represented the cash receipts and disbursements related to all of our activities other than investing and financing activities. We have historically financed our operating and capital expenditures primarily through cash flows earned through our operations. We expect cash provided by operating activities, in addition to our cash, cash equivalents and marketable securities, will continue to be a primary source of funds to finance operating needs and capital expenditures.

Operating cash flow is derived by adjusting our net income (loss) for:

•Non-cash operating items, such as depreciation and amortization and equity-based compensation; and

•Changes in operating assets and liabilities, which reflect timing differences between the receipt and payment of cash associated with transactions and when they are recognized in results of operations.

For the nine-months ended September 30, 2020 compared to the nine-months ended September 30, 2019, net cash flows used in operating activities decreased by $99.0 million, driven primarily by a decrease in net loss as adjusted for non-cash charges of $150.4 million, partially offset by a $51.5 million increase due to changes in operating assets and liabilities. Included within net loss for the period ended September 30, 2019 was $74.9 million of acquired IPR&D expense related to the Perosphere asset acquisition, of which $60.8 million was paid in cash during the first quarter of 2019.

Investing Activities

Cash flows used in investing activities was $7.6 million for the nine months ended September 30, 2020 due primarily to net purchases of marketable securities of $12.1 million offset by net proceeds of $4.9 million from the sale of assets. Cash provided by investing activities for the nine months ended September 30, 2019 was $8.4 million due to net proceeds from sales of marketable securities of $70.5 million offset by a milestone payment for the Vyleesi developed technology of $60.0 million and capital expenditures of $2.1 million.

Financing Activities

Cash used in financing activities was $0.6 million for the nine months ended September 30, 2020 due primarily to $1.4 million for payments of employee tax withholdings related to equity based compensation offset by $0.6 million of proceeds from the issuance of common stock under the ESPP. Cash used in financing activities for the nine months ended September 30, 2019 was $36.1 million primarily due to the repayment of the $21.4 million balance of our 2019 convertible notes, $13.7

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million for common stock repurchases and $1.8 million for payments of employee tax withholdings related to equity based compensation.

Future Liquidity Considerations

We believe that our cash, cash equivalents and marketable securities as of September 30, 2020, and the cash we expect to receive from sales of our products, will be sufficient to fund our current operating plans and capital expenditure requirements for at least twelve months from the date of issuance of these financial statements.

We generated negative cash flows from operations during the nine months ended September 30, 2020 and during the year ended December 31, 2019. Our expected cash flows from operations between now and June 1, 2022, the maturity date of our 2022 Convertible Notes, will be insufficient to settle these Convertible Notes. Therefore, in the event that the Merger with Covis described in Note T, Subsequent Events, is not completed, we expect that we will need to issue new securities, in the form of debt, equity or equity-linked, or some combination thereof, and it may be challenging for us to do so on favorable terms in light of the impact of COVID-19 on the global economy and financial markets.

Notwithstanding the above, given the uncertainties around the severity and duration of COVID-19, our forecasted cash flows for the remainder of 2020 could be adversely impacted if actual events differ from our estimates.

For a detailed discussion regarding the risks and uncertainties related to our liquidity and capital resources and to the potential impact of the COVID-19 pandemic, please refer to our Risk Factors in Part I, Item 1A of our Annual Report and in Part II, Item IA of this Quarterly Report on Form 10-Q. 

Borrowings and Other Liabilities

In the second quarter of 2017, we issued $320.0 million aggregate principal amount of convertible senior notes due 2022 (the “2022 Convertible Notes”), as discussed in more detail in Note P, “Debt,” to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q. The 2022 Convertible Notes are senior unsecured obligations and bear interest at a rate of 3.25% per year, payable semi-annually in arrears on June 1 and December 1 of each year, beginning on December 1, 2017. The 2022 Convertible Notes will mature on June 1, 2022, unless earlier repurchased or converted. Upon conversion of the 2022 Convertible Notes, such 2022 Convertible Notes will be convertible into, at our election, cash, shares of our common stock, or a combination thereof, at a conversion rate of 36.5464 shares of common stock per $1,000 principal amount of the 2022 Convertible Notes, which corresponds to an initial conversion price of approximately $27.36 per share of our common stock. The conversion rate is subject to adjustment from time to time. The 2022 Convertible Notes were not convertible as of September 30, 2020.

In the event our Merger with Covis described in Note T, “Subsequent Events,” to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, is completed, following the closing of the transaction, Covis has agreed to cause AMAG to take certain actions required by the indenture governing the 2022 Convertible Notes (as supplemented, the “Indenture”). Specifically, if the Merger is consummated, then, in accordance with the terms of the Indenture, Covis will cause AMAG to provide written notice (a “Fundamental Change Company Notice”) to all holders of the 2022 Convertible Notes notifying such holders of their right to require AMAG to repurchase for cash such holder’s 2022 Convertible Notes (the “Repurchase Right”) at a repurchase price equal to 100% of principal amount thereof, plus accrued and unpaid interest thereon to, but excluding, the date specified by AMAG in the Fundamental Change Company Notice. Additionally, AMAG will, in accordance with the terms of the Indenture, enter into a supplemental indenture providing that the right to convert each $1,000 principal amount of 2022 Convertible Notes shall be changed into a right to convert such principal amount of 2022 Convertible Notes into the amount of cash that a holder of shares equal to the conversion rate immediately prior to the Merger would have been entitled to receive in the Merger, or $502.513, which represents the conversion rate of 36.5464 shares per $1,000 principal amount, multiplied by the cash paid per share in the Merger of $13.75 (with no further right to convert into shares of AMAG or any other entity). If the Offer is closed, holders will have a right, which right must be exercised during the period from the date of the Merger until the close of business on the business day immediately preceding the Fundamental Change Repurchase Date (as defined in the Indenture), to convert such holder’s 2022 Convertible Notes (the “Conversion Right”) into cash as described above. Since the purchase price per share in the Merger is less than $19.90, the conversion rate will not be increased in connection with the transactions.

If the Merger is consummated, holders of the 2022 Convertible Notes will have the right to either (i) exercise their Repurchase Right, (ii) exercise their Conversion Right or (iii) decline to exercise either of those rights, in which case their 2022 Convertible Notes will remain outstanding subject to their then existing terms.

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Share Repurchase Program

As of January 1, 2020, we had $26.8 million available under the share repurchase program initially approved by our Board of Directors in January 2016, which was updated in March 2019 to permit the repurchase of up to an aggregate of $80.0 million in shares of our common stock. During the nine months ended September 30, 2020, we did not repurchase shares of common stock under this program. As of September 30, 2020, $26.8 million remained available for future repurchases under this program. 

Off-Balance Sheet Arrangements

As of September 30, 2020, we did not have any off-balance sheet arrangements as defined in Regulation S-K, Item 303(a)(4)(ii).

Impact of Recently Issued and Proposed Accounting Pronouncements

See Note S, “Recently Issued and Proposed Accounting Pronouncements,” to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for information regarding new accounting pronouncements.

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,” in 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 not effective due to the material weakness in internal control over financial reporting described below.

During the second quarter of 2020, we identified a material weakness in our internal control over financial reporting related to ensuring the timely recognition of our gross-to-net (“GTN”) adjustments for certain governmental rebates and the related accruals. Specifically, we did not design and maintain controls to allow for an effective review of the completeness over government rebate arrangements, including disputed claims, where the decision has been made to initially not record and accrue for such items, to assess whether and when the need to record an accrual is required for such claims.

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of the Company’s annual or interim financial statements will not be detected on a timely basis. Although the identified governmental rebate and accrual event was immaterial to our financial statements in the impacted time periods, we determined that there was a risk that a similar event could have occurred without being prevented or detected on a timely basis that could have given rise to a potentially material misstatement in our financial statements or disclosures.

We have already taken certain steps and will take additional steps to remediate this material weakness, including the development of enhanced controls governing our GTN adjustments for governmental rebates and accruals.

Our remediation efforts are intended to address the identified material weakness. Management is committed to continuous improvement of our internal control over financial reporting and will continue to diligently review our internal control over financial reporting.

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 September 30, 2020 that have materially affected, or that are reasonably likely to materially affect, our internal control over financial reporting.

PART II. OTHER INFORMATION

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Item 1. Legal Proceedings:

See Note N, “Commitments and Contingencies,” to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q for information regarding our legal proceedings, including how we accrue liabilities for legal contingencies.

Item 1A. Risk Factors:

With the exception of the risk factors below, there have been no material changes from the Risk Factors disclosed in Part I, Item 1A, of our Annual Report.

The scale and scope of the novel coronavirus (“COVID-19”) pandemic is unknown and continues to rapidly evolve. It has caused unprecedented disruption to global economies and poses a significant threat to the healthcare industry and infrastructure throughout the world, which has had and could continue to have a negative impact on our business.

The global spread of COVID-19 has created significant volatility, uncertainty and economic disruption on a global scale, including in the United States, where we market Feraheme and Makena, where our operations and employees reside and where we conduct clinical trials. The extent to which the COVID-19 pandemic impacts our business, operations and financial results will depend on numerous evolving factors that we may not be able to accurately predict, including:

•the duration and scope of the pandemic;

•governmental, business and individuals’ protocols and actions that have been and continue to be taken in response to the pandemic;

•the impact of the pandemic on economic activity and actions taken in response;

•the effect on patients, healthcare providers and business partners;

•demand for our products, including as a result of reduced patient visits to healthcare providers, travel restrictions, social distancing, quarantines and other containment measures;

•uncertainty as to when we will be able to initiate our clinical trials, particularly at clinical trial sites located in highly impacted geographies and as a result of disruptions with our CROs;

•the ability to obtain, deliver or distribute sufficient and timely supplies if the production capabilities of manufacturers and suppliers or transportation (including with our CMOs and 3PLs) is disrupted;

•our access to the debt and equity markets, including our ability to enter into a restructuring transaction for our 2022 Convertible Notes, on satisfactory terms, or at all if the transaction with Covis is not consummated on the expected timeline or at all;

•disruptions in regulatory oversight and actions if regulators and industry professionals are expending significant and unexpected resources addressing COVID-19;

•any impact on our rebate payment liability, including as a result of any changes in the terms or mix of coverage and reimbursement from government and health administration authorities, private health insurers and other third-party payors; and

•any closures of our and our partners’ offices, operations and facilities.

For example, we observed a decline in Feraheme and Makena sales as COVID-19 protocols restricted or discouraged patient access to hospitals, clinics, physicians’ offices and other sites where Feraheme and Makena are typically administered and caused a re-prioritization of healthcare services, and we may observe future declines in sales if such restrictions continue or there is a return to the prior levels of COVID-19 cases. Further, although we have implemented remote selling tactics, such initiatives may not be as successful as traditional, in-person interactions.

In addition, as a result of the COVID-19 pandemic, the initiation of our planned ciraparantag Phase 2b trial was delayed due to site shutdowns and an inability to enroll while COVID-19 protocols were in place. Due to the continuing impact of COVID-19, the study may be further delayed or take longer than anticipated. For example, COVID-19 might present further challenges if study candidates are hesitant to enroll because of concerns over the contagiousness of COVID-19 or if additional screening criteria will need to be effectuated. As a result, we expect delays in our clinical program, but due to the uncertainties caused by COVID-19, the scope of the delay is presently unknown.

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Although we have taken steps to mitigate risks related to the COVID-19 pandemic on our employees, including by implementing a work from home policy for all employees, such efforts are vulnerable to disruptions that may occur if the digital infrastructures are insufficient to accommodate the increased usage as social distancing is implemented on a global scale.

The scope and scale of COVID-19 is unprecedented and its duration and impact cannot be predicted with any certainty. Its impact could have a material and adverse impact on our revenues and operations, which could cause a decline in our stock price. To the extent the COVID-19 pandemic adversely affects our business and financial results, it may also have the effect of heightening many of the other risks described in this “Risk Factors” section and in the “Risk Factors” section of our Annual Report on Form 10-K, including, in particular, risks related to the timelines for our development programs, risks related to our ability to achieve and/or maintain profitability, and risks related to our complete dependence on third parties for the manufacture of our products.

Failure to complete the pending transaction with Covis could negatively impact our business, financial results and stock price.

On October 1, 2020, we entered into a merger agreement with Covis Group S.a.r.l. (“Covis”), pursuant to which Covis will acquire all of the outstanding shares of our common stock for $13.75 per share in cash through a tender offer and second-step merger (the “Merger”). Covis’ obligation to purchase the shares validly tendered pursuant to the tender offer is subject to the satisfaction or waiver of customary conditions, including (i) there being validly tendered, and not validly withdrawn prior to the expiration date of the tender offer, shares representing one more than 50% of the total number of shares outstanding (together with any shares held by Covis or its affiliates) and issuable to holders of options and 2022 Convertible Notes that have exercised their options or given notice of conversion as of the expiration date (the “Minimum Condition”), (ii) the expiration or termination of the waiting period (and any extension thereof) applicable to the consummation of the tender offer and the merger under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (which condition was satisfied on October 23, 2020), (iii) the absence of any law that prohibits consummation of the tender offer or the merger, (iv) the absence of any continuing event, development or circumstance that has had or would reasonably be expected to have a material adverse effect (as defined in the merger agreement), (v) the representations and warranties of the Company are true and correct (subject to certain materiality qualifiers) as of the date of the Agreement and the closing, as well as other customary conditions set forth in the merger agreement. As a result, we cannot assure you that the transaction with Covis will be completed, or that, if completed, it will be exactly on the terms set forth in the merger agreement or within the expected time frame. If the transaction with Covis is not completed in a timely manner, or at all, our business, financial results and stock price may be adversely affected and we will be subject to certain risks and consequences, including the following:

•The price of our common stock may decline to the extent that current market prices reflect a market assumption that the merger will be completed;

•If the merger agreement is terminated under specified circumstances, we may be required to pay Covis a termination fee of $16.25 million;

•We will be required to pay various costs relating to the pending transaction regardless of whether it is completed, such as significant fees and expenses for legal, accounting, financial advisory, and printing services;

•Matters relating to the pending transaction may require substantial time and effort from our management team and other employees, which time and effort distracts from our core business and could have otherwise been devoted to other opportunities that might have been beneficial to AMAG;

•We may experience negative reactions from the financial markets and from our employees, customers, partners, and vendors if the transaction is not completed; and

•Shareholder litigation challenging the proposed Merger has been and may continue to be commenced against us and may delay completion of the Merger in the expected timeframe or altogether. If the plaintiffs in any such litigation are successful in obtaining an injunction prohibiting the parties from consummating the Merger on the terms contemplated by the merger agreement, the injunction may prevent the completion of the Merger in the expected timeframe or altogether. In addition, litigation challenging the Merger may result in significant defense costs and serve as a distraction to management and directors.

We are subject to business uncertainties and contractual restrictions while the transaction with Covis is pending.

Uncertainty about the effect of the pending transaction with Covis on our employees, customers, partners and vendors may have an adverse effect on our business, financial condition and results of operations. These uncertainties may impair our ability to retain and motivate key personnel and could cause customers, partners, vendors, and others that deal with us to defer entering into contracts with, or making other decisions concerning, AMAG or to seek to change existing business relationships with us.

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The loss or deterioration of relationships with significant customers, partners, licensees or suppliers could have a material adverse effect on AMAG. The merger agreement generally requires us to operate our business in the ordinary course of business consistent with past practice, but restricts us from taking specified actions while the transaction is pending without the consent of Covis, including, among other things, restrictions on our ability to acquire other businesses and assets, dispose of or license our assets and intellectual property, enter into, modify, or terminate certain contracts, repurchase or issue securities, make capital expenditures, incur indebtedness, or hire, promote, terminate, alter, or accelerate the compensation of certain employees. These restrictions may prevent us from pursuing attractive business opportunities or responding effectively and/or timely to competitive pressures and industry developments that may arise prior to the completion of the pending transaction or otherwise adversely affect our ability to execute on our business strategy, which could adversely affect our business or financial condition.

If the FDA withdraws Makena’s approval or changes its label, or if healthcare providers are reluctant to continue prescribing Makena due to the results of the PROLONG trial or given the availability of generic alternatives, our revenues and results of operations will be materially adversely impacted.

In March 2019, we announced topline results from the Progestin’s Role in Optimizing Neonatal Gestation clinical trial (“PROLONG” or “Trial 003”), which evaluated Makena in patients with a history of a prior spontaneous singleton preterm delivery. The PROLONG trial was conducted under the FDA’s “Subpart H” accelerated approval process to confirm the efficacy of the Meis trial (“Trial 002”), which supported Makena’s 2011 FDA approval. The PROLONG trial results did not demonstrate a statistically significant difference between the treatment and placebo arms for the co-primary endpoints.

On October 29, 2019, the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee (the “Advisory Committee”) met to discuss the PROLONG study and provide the FDA input to inform the FDA’s regulatory decision for Makena. At the conclusion of the meeting, nine members of the Advisory Committee voted to recommend that the FDA withdraw its approval of Makena, seven voted to leave Makena on the market under accelerated approval and require a new confirmatory trial and no member voted to leave Makena on the market without requiring a new confirmatory trial. On October 5, 2020, the FDA’s Center for Drug Evaluation and Research sent us a proposal to withdraw marketing approval of Makena and notice of opportunity for a hearing (the “Notice”). The Notice provided us with the opportunity to request a hearing within 15 days of receipt of the Notice and invited holders of the approved generics of Makena to submit comments. On October 14, 2020, we filed a request for a hearing with the FDA, together with an extension request for providing the supplemental information in support of our request for a hearing. On October 22, 2020, the FDA agreed to an extension, and we plan to submit to the FDA by December 4, 2020 data, information, and analyses to demonstrate that there is a genuine and substantial issue of material fact that requires a hearing. The Makena label remains unchanged during the pendency of this process. The FDA’s decision may be influenced by a Citizen Petition that requested that the FDA withdraw its approval of Makena based on the failure of the Makena clinical data to establish evidence of efficacy for preterm birth. We responded to the Citizen Petition by providing the FDA with arguments to support the positive benefit-risk profile of Makena, and, on October 5, 2020, the FDA denied the Citizen Petition’s request to immediately withdraw its approval of Makena, but referenced the Notice sent to us.

If the FDA withdraws its approval of Makena, our revenues and results of operations will be materially and adversely impacted, including due to the potential recognition of additional revenue reserves, inventory write-downs and payments for minimum purchase obligations of inventory. Even if the FDA were to decide against withdrawal of Makena from the market at this time, it is likely that the FDA would require us to generate additional data or conduct additional clinical trials as a condition to Makena’s continued commercialization. We may not be able to generate additional efficacy data that will be satisfactory to the FDA in a timely manner, or at all, and the generation of such data is likely to be costly and take a considerable amount of time to generate. Further, other organizations have conducted and may conduct additional studies that result in findings similar to those in the PROLONG study, which may influence the decisions and guidance provided by healthcare physicians or professional organizations related to the use of Makena. Additionally, in light of the results from the PROLONG study, including discussions and recommendations of the Advisory Committee and the FDA’s issuance of the Notice, healthcare providers have been and may continue to be reluctant to continue prescribing Makena, or the FDA may require that our label include information on the PROLONG study, restrictions to the current indication or the insertion of new warnings or precautions. Further, in light of the recommendation of the Advisory Committee that the FDA withdraw the approval of Makena, and the Notice, certain medical professional organizations and other societies could change their guidelines to physicians, which could cause payors to change the formulary coverage or reimbursement for Makena or health care practitioners could stop prescribing Makena. Any of these outcomes could negatively impact or prevent our ability to commercialize Makena, which would materially and adversely impact our results of operations and could materially and adversely impact our stock price.

The commercial success of Makena (if approval is not ultimately withdrawn by the FDA) is exclusively dependent upon sales from the pre-filled subcutaneous auto-injector (the “Makena auto-injector”). Although there is no direct competition with

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the Makena auto-injector, the Makena auto-injector competes for the same patients as generic versions of the Makena intramuscular (“IM”) injection (the “Makena IM product”), and we cannot guarantee that we will be able to continue to convince patients or healthcare providers to use the auto-injector instead of using the IM method of administration, including (1) if patients or healthcare providers are hesitant or apprehensive to use an auto-injector product due to perceptions regarding safety, efficacy or pain associated with the Makena auto-injector, or in light of the recommendations of the Advisory Committee, the Notice or any other actions taken by the FDA that negatively impact Makena, (2) if the auto-injector is not priced competitively or is not provided comparable insurance coverage, or (3) if there are concerns about the quality or reliability of our Makena supply chain more generally in light of the previous supply disruptions related to our Makena IM products or if we experience a similar supply disruption for the Makena auto-injector. We expect that the Makena auto-injector may continue to experience pricing and supply chain pressure (if approval is not ultimately withdrawn by the FDA) and as a result, our financial condition and results of operations could be adversely impacted. If we are unsuccessful with any such efforts, Makena revenues could continue to be negatively and materially impacted, which could have a material and negative impact on our stock price and results of operations. Additionally, Makena is labeled for administration weekly by a healthcare professional. Covid-19 may cause providers to be hesitant to prescribe a product that requires weekly interaction with patients, which could have a material and negative impact on Makena revenues.

Actions that we have taken to streamline our business, including divestitures of Intrarosa® (prasterone) and Vyleesi® (bremelanotide injection) and our workforce reductions, may not be as effective as anticipated and could have a negative impact on our results of operations.

As previously disclosed, we implemented a workforce reduction as a result of the divestiture of Intrarosa and Vyleesi and the impact of COVID-19. We undertook this workforce reduction in an effort to streamline our business, reduce expenses and conserve cash.

However, there can be no assurance that these efforts will result in the expected cost-cutting and cash-savings, or otherwise create any shareholder value. These undertakings were, and the reduction in our workforce may continue to be, disruptive to our operations, particularly given the challenges posed by the COVID-19 pandemic, including by distracting management from our core business, affecting employee productivity and morale, or impacting our ability to hire or retain key personnel, any of which could, in turn materially and adversely impact our operations. Further, we are accustomed to operating as a larger enterprise and may face challenges in scaling our operations and balance sheet to manage our more streamlined business, including by over or under estimating the amount of support the various functions of our business will require. In addition, such actions could impair our development, marketing, sales and patient support efforts or alter our product development plans, and could make it more difficult for us to deploy resources towards business development, or financial or other strategic, opportunities.

The divestitures also involve additional risks associated with the separation of operations, services, products and personnel, including our obligations to provide transitional services for a period of time after closing. The provision of transitional services could divert management’s attention or otherwise disrupt our business, or we may not provide such transitional services to the satisfaction of the transferee. Such consequences, and any unanticipated consequences, of our recent divestiture and work force reduction could have a material and adverse effect on our stock price, particularly if shareholders are not supportive of our streamlined business approach.

We have limited experience with development and development stage products and cannot ensure that we will be successful in gaining approval of ciraparantag and any product candidates that may be added to our pipeline or in completing any post-approval commitments for our approved products, on a timely basis, or at all, and even if our development stage products are approved, we may not be successful in commercializing such products. Additionally, any approvals that we obtain may contain unexpected restrictions on the use or distribution of such products imposed by the FDA or other regulatory agencies, which could adversely and materially affect our long-term success.

Our long-term success and ability to sustain and grow revenue depends upon our ability to continue to successfully acquire, in-license, out-license and develop product candidates. Drug development is inherently risky, time consuming, unpredictable and costly. The FDA and other regulatory agencies, such as the European Medicines Agency (the “EMA”) or the Medicines and Healthcare Products Regulatory Agency (the “MHRA”) where our license partners will seek approval, each imposes substantial requirements on the development of such candidates to become eligible for marketing approval and has substantial discretion in the approval process.

We currently have one product candidate in development in our pipeline: ciraparantag, which is in development for patients treated with novel oral anticoagulants or low molecular weight heparin when reversal of the anticoagulant effect of these products is needed for emergency surgery, urgent procedures or due to life-threatening or uncontrolled bleeding. Additionally,

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we have on-going post-approval commitments for Feraheme that require us to conduct pediatric studies to comply with the requirements of the Pediatric Research Equity Act.

Any failure, delay or setback in obtaining regulatory approval for this product candidate or in completing our post-approval commitments, or setback resulting from our inability to sufficiently fund or otherwise support our pipeline through approval or to timely complete our post-approval commitments, including as a result of the COVID-19 pandemic, could lead to adverse publicity and/or regulatory action and could adversely affect our ability to maintain or grow our business and leverage our product portfolio, and the future prospects of our business could be materially adversely affected.

The approval of our current or future product candidates for commercial sale in the U.S. or by our license partners outside the U.S. could be delayed, limited or denied or we may be required to conduct additional studies for a number of reasons, including, but not limited to, that:

•The FDA or other regulatory agencies may determine that our product candidates do not demonstrate safety and efficacy in accordance with regulatory agency standards based on a number of considerations, including adverse medical events that are reported during the trials;

•The FDA or other regulatory agencies could analyze and/or interpret data from clinical trials and preclinical testing in different ways than we or our partners interpret them and determine that our data is insufficient for approval;

•The FDA or other regulatory agencies may require more information, including additional preclinical or clinical data or trials, to support approval;

•Devices we may use in combination with our products may not be adequate or may not be considered adequate by the FDA or other regulatory agencies, such as the coagulometer we intend to use in the Phase 2 and Phase 3 clinical programs for ciraparantag;

•The FDA or other regulatory agencies could determine that our manufacturing processes are not properly designed, are not conducted in accordance with federal or other applicable laws or otherwise not properly managed, and we may be unable to establish, and obtain FDA or other regulatory approval for, a commercially viable manufacturing process for our product candidates in a timely manner, or at all;

•The supply or quality of our product candidates for our clinical trials may be insufficient, inadequate or delayed, or we may not be able to obtain sufficient or consistent supply for clinical trials that we or our license partners need to conduct;

•The size of the patient population required to establish the efficacy of our product candidates to the satisfaction of the FDA or other regulatory agencies may be larger than we anticipated;

•The failure of clinical investigational sites and the records kept at such sites, including the clinical trial data, to be in compliance with the FDA’s current good clinical practices regulations (“cGCP”), including the failure to pass FDA or other regulatory agencies inspections of clinical trial sites;

•The FDA or other regulatory agencies may change their approval policies or adopt new regulations;

•The FDA or other regulatory agencies may not be able to undertake reviews or approval processes in a timely fashion;

•The results of the earlier clinical trials may not be representative of our future, larger trials, particularly since the presumed mechanism of action for certain of our products is not known or understood; for instance, ciraparantag has only been studied in a small number of healthy volunteers;

•The FDA or other regulatory agencies may not agree with our regulatory approval strategies or components of our regulatory filings, such as the design or implementation of our clinical trials; for instance, we are relying on precedent to estimate the number of patients required in our Phase 3 ciraparantag trial prior to filing the New Drug Application (“NDA”), and the FDA may not agree with our approach and our other expectations for these clinical trials may not ultimately be approved by the FDA; or

•A product may not be approved for the indications that we request.

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In addition to the risks described above, development programs can face specific challenges depending on the nature of the patient population, the potential indications, and the science involved. For example, our ciraparantag program faces certain risks, including:

•The timing and/or complexity of our upcoming Phase 2b study could be negatively impacted for a number of reasons, including (i) due to the FDA requirement that we use a manual whole blood clotting time (“WBCT”) in addition to the automated coagulometer, which is a difficult and time-consuming process; (ii) if the FDA requires us to explore additional dosing; (iii) if we do not get agreement from the Center for Drug Evaluation and Research on our Phase 2b protocol in a timely manner, which would delay the Investigational Device Exception (“IDE”) approval timeline; (iv) due to the continuing impact of the COVID-19 pandemic, the scope of which is presently unknown and difficult to predict, initiation of the Phase 2b study may be further delayed, or the study may take longer than anticipated; or (v) if the Center for Devices and Radiological Health (“CDRH”) has questions about the IDE or requires Perosphere Technologies to complete additional studies to obtain the IDE;

•The coagulometer that we intend to use in the ciraparantag Phase 2 and Phase 3 trials has not yet received IDE approval or been used in clinical trials and therefore, the FDA may (i) determine that the device is not effective in measuring WBCT, and/or (ii) not grant the IDE, which is necessary prior to the use of the coagulometer in our clinical trials; in such circumstances, ciraparantag may not receive regulatory approval or its approval would be delayed. Moreover, the FDA may only approve ciraparantag in conjunction with the use of the coagulometer (i.e. as a companion diagnostic), which could affect the commercial viability of ciraparantag;

•Our NDA or other regulatory filings for ciraparantag could be delayed if (i) we are not able to gain agreement with the FDA or other regulatory authority on CMC, clinical pharmacology or our pre-clinical program, including if the FDA or other regulatory authority requires us to conduct potential additional trials prior to commencing the Phase 3 program; (ii) if we are not eligible for the accelerated approval pathway or the FDA or other regulatory agency requires more patient data before filing than anticipated; or (iii) if the FDA or other regulatory agency requires additional Phase 3 trials; and

•Even if approved, ciraparantag may not be approved with all three direct oral anticoagulants (“DOACs”) as well as Lovenox® (enoxaparin sodium injection), a low molecular weight heparin (“LMWH”), which could affect market acceptance and revenue.

In addition, share prices have declined significantly in certain instances where companies have failed to obtain FDA approval of a product or where the timing of FDA approval is delayed. If we are required to conduct additional studies or our studies take longer than anticipated, our share price could decline significantly. Further, the market for products that address unmet medical needs is highly speculative and if we have over-estimated the market opportunity for any of our products or product candidates, or if we are unsuccessful in gaining market share, then our business and results of operations could be materially and adversely affected.

Even if regulatory approval is granted by the FDA to market our current or future product candidates, the FDA may impose limitations on the indicated use for which the drug product may be marketed or require additional post-approval clinical trials or other requirements with which we would need to comply in order to maintain approval of these products. The occurrence of any of these scenarios could materially harm the commercial prospects of our product candidates and our business could be seriously harmed, particularly in light of our streamlined product portfolio.

We previously identified a material weakness in our internal control over financial reporting; this material weakness and any we identify in the future could negatively impact the trading price of our stock and could make it more challenging to meet our reporting obligations.

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

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

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results, and the price of our common stock could be negatively affected. If we cannot conclude that we have effective internal controls over our financial reporting, or if we are unable to timely and adequately remediate material weaknesses, which could lead to our independent registered public accounting firm being unable to provide an unqualified opinion, or needing to amend or withdraw a previously issued opinion, regarding the effectiveness of our internal control over financial reporting, it could result in errors in our financial statements or delays or failures to comply with reporting requirements or investors could lose confidence in the reliability of our financial statements, which could lead to a decline in our stock price and potential claims by investors regarding the adequacy of our disclosures. Failure to comply with reporting requirements could subject us to sanctions and/or investigations by the U.S. Securities and Exchange Commission, NASDAQ or other regulatory authorities.

For example, as previously reported, we identified a material weakness in our internal control over financial reporting related to ensuring the timely recognition of our gross-to-net (“GTN”) adjustments for certain governmental rebates and the related accruals. Specifically, we did not design and maintain controls to allow for an effective review of the completeness over government rebate arrangements, including disputed claims, where the decision has been made to initially not record and accrue for such items, to assess whether and when the need to record an accrual is required for such claims. Although we have already taken certain steps and will take additional steps to remediate this material weakness, including the development of enhanced controls of our GTN adjustments for governmental rebates and accruals, such remediation efforts may be inadequate to remedy the weakness. In addition, our conclusion that we have a material weakness could give rise to internal and external increased scrutiny, review, audit and investigation over our accounting controls and procedures, which could uncover additional areas of deficiency or errors in our financial statements, which could have a material and adverse impact on our business.

Our existing collaborations, including with Norgine B.V. (“Norgine”), are important to our business, and future collaborations may also be important to us. If we are unable to maintain any of these collaborations, or if these collaborations are not successful, our business could be adversely affected.

We have limited capabilities for drug development and approval outside of the U.S. and do not have any capability for sales, marketing or distribution outside the U.S. Accordingly, we have entered into a License and Collaboration Agreement with Norgine pursuant to which AMAG and Norgine will collaborate on the Phase 3 development of ciraparantag, and Norgine will seek regulatory approval for, market and sell ciraparantag in certain countries in Europe, Australia and New Zealand. In the future, we may enter into additional collaborations for the development, marketing or sale of ciraparantag or our other products in the U.S. or abroad. We must work effectively and collaboratively with our collaboration partners to develop, market and/or sell our products, and if we cannot do so effectively, disagreements could arise. Such disagreements could delay the related program or result in distraction or expensive arbitration or litigations, which may not be resolved in our favor.

Our license agreement with Norgine contains complex provisions and imposes diligence, development and other obligations on us and provides Norgine with certain consent rights that restrict our ability to make changes to our development plan or priorities. If we fail to comply with our obligations or are unable to reach agreement with Norgine on changes to the development plan, the ciraparantag development program may be delayed, our costs may be significantly greater than anticipated, or Norgine may have the right to terminate the license agreement. For example, we are required to use commercially reasonable efforts to conduct a Phase 3 clinical program for ciraparantag that is sufficient to support the filing for regulatory approval with the FDA, EMA and MHRA. If we and Norgine do not agree, or the agencies do not agree, on the appropriate design, or the EMA and MHRA impose different or more rigorous requirements for the Phase 3b trial than required by the FDA, our ability to complete the Phase 3 trial and obtain regulatory approval from the FDA may be delayed or cost significantly more than anticipated. If we disagree on the development plan or Norgine does not think that we have used the appropriate level of effort, a disagreement could arise that might cause delay, might lead to additional responsibilities for us beyond those anticipated, or might result in litigation or arbitration, any of which would be time-consuming and expensive.

Similarly, under the terms of the option agreement with Velo Bio, LLC (“Velo”), pursuant to which we acquired the global rights to the AMAG-423 program, we are required to use commercially reasonable efforts to develop and commercialize AMAG-423. As discussed above, based on the study’s independent Data Safety Monitoring Board’s unanimous recommendation to stop the study following an interim analysis of the data collected to date in the study, we decided to stop the AMAG-423 Phase 2b/3a trial. However, if Velo believes that we are not complying with our obligations, a dispute may arise and we may be subject to litigation, which would be time-consuming and expensive.

Under the terms of the agreement with Norgine, we are required to supply Norgine with its requirements of clinical and commercial supply of ciraparantag. However, we rely on third parties to manufacture ciraparantag, and if we fail to enter into commercial supply agreements with such parties by a time specified in our agreement with Norgine, or we fail to supply Norgine in accordance with the terms of the license agreement, or we materially breach the supply agreement to be entered into with Norgine, or the supply price of ciraparantag exceeds certain benchmarks, Norgine could elect to obtain their own supplier, in which case we would be responsible for reimbursing them for certain costs of obtaining such supplier, which could be

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substantial in certain circumstances, and we may be subject to minimum penalties under our own supply arrangements. Additionally, we may be required to implement changes in our manufacturing process to meet the requirements of certain regulatory agencies in the licensed territory, which may be different from the FDA’s requirements, and could be costly, time intensive, or constrain the amount of supply that our third-party manufacturer can manufacture for the U.S.

In addition, we rely on Norgine, and may in the future rely on other partners in various respects, including obtaining regulatory approval for and commercializing our products. We do not control our partners, and cannot ensure that they will adequately and timely perform all of their obligations to us. We cannot guarantee the satisfactory performance of any of our partners, and if our current or future collaborations do not result in the successful development and commercialization of products, or if one of our collaborators does not commit sufficient resources to the marketing and distribution of our product after achieving regulatory approval, or if one of our collaborators terminates its agreement with us, we may not receive all or any of the future research funding or milestone or royalty payments under the collaboration. If we do not receive the funding we expect under these agreements, our development of our current or future product candidates could be delayed or we may not have sufficient resources to market our approved products, and we may need additional resources to develop and commercialize our products and product candidates. In addition, if any of our partners fail to comply with regulatory requirements regarding the development, distribution or marketing of a product or product candidate, or infringes the intellectual property rights of third parties, we may be exposed to regulatory action or litigation, which would be time consuming and expensive. All of the risks relating to product development, regulatory approval and commercialization described in our Annual Report on Form 10-K and this Quarterly Report on Form 10-Q also apply to the activities of our therapeutic collaborators.

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 September 30, 2020.

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 (or approximate dollar value) That May Yet Be Purchased Under the Plans or Programs (2)
July 1, 2020 through July 31, 2020	5,533	$	8.29	—	2,800,091
August 1, 2020 through August 31, 2020	492	10.62		—	2,582,516
September 1, 2020 through September 30, 2020	2,313	9.64		—	2,846,263
Total	8,338	$	8.80	—

_________________________

(1)Includes the surrender of 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 did not repurchase shares of our common stock during the third quarter of 2020. We have repurchased and retired $53.2 million of our common stock under our share repurchase program through September 30, 2020. These shares were purchased pursuant to a repurchase program initially approved by our Board of Directors in January 2016, which was updated in March 2019 to permit the repurchase of up to $80.0 million of our common stock, of which $26.8 million remained authorized for repurchase as of September 30, 2020. The repurchase program does not have an expiration date and may be suspended for periods or discontinued at any time.

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Item 5. Other Information:

During the third quarter of 2020, in conjunction with our remediation efforts related to the errors identified during the second quarter of 2020 (see Note R, “Revision of Prior Period Financial Statements,” to our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q), we identified certain individually immaterial errors aggregating to $5.2 million related to governmental rebate accruals associated with Makena sales during the first and second quarters of 2020. We understated our gross-to-net (“GTN”) adjustments for governmental rebates and the related accrual for certain state programs by $2.8 million for the quarter ended March 31, 2020 and $2.8 million for the quarter ended June 30, 2020. This understatement also resulted in an overstatement of our related royalty obligation by $0.2 million as of March 31, 2020 and $0.2 million as of June 30, 2020. During the third quarter of 2020, we concluded that the errors were not material to any prior interim periods. However, we determined that correcting the aggregate errors within the three months ended September 30, 2020 would be material to the period. As a result, we have revised our historical financial statements to properly reflect the GTN adjustments and related royalty impact and accrual in the appropriate periods through an immaterial correction.

The effect of the corrections to our condensed consolidated statements of operations for the three months ended March 31, 2020 and June 30, 2020 were as follows (in thousands, except per share amounts):

	Three Months Ended March 31, 2020
	As reported		Q2'20 Adj		Q3'20 Adj		As adjusted
Product sales, net	$	68,628	$	1,783	$	(2,807)	$	67,604
Total revenues	68,661		1,783		(2,807)		67,637
Cost of product sales	24,359		—		(225)		24,134
Net loss	$	(24,491)	$	1,783	$	(2,582)	$	(25,290)
Basic and diluted net loss per share	$	(0.72)	$	0.05	$	(0.07)	$	(0.74)

	Three Months Ended June 30, 2020
	As reported		Adjustment		As adjusted
Product sales, net	$	52,729	$	(2,863)	$	49,866
Total revenues	52,755		(2,863)		49,892
Cost of product sales	18,180		(229)		17,951
Net loss	$	(13,244)	$	(2,634)	$	(15,878)
Basic and diluted net loss per share	$	(0.39)	$	(0.07)	$	(0.46)

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Item 6. Exhibits:

Exhibit Number	Description
2.1*	Agreement and Plan of Merger, dated as of October 1, 2020, by and among AMAG Pharmaceuticals, Inc., Covis Group S.à r.l. and Covis Mergerco, Inc. (incorporated herein by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filed October 1, 2020)
10.1+*^	License and Commercialization Agreement, effective as of July 23, 2020, by and between AMAG Pharmaceuticals, Inc. and Norgine B.V.
10.2*^	Termination Agreement, dated July 24, 2020, by and between AMAG Pharmaceuticals, Inc. and Palatin Technologies, Inc. (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed July 27, 2020)
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.SCH+	Inline XBRL Taxonomy Extension Schema Document
101.CAL+	Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.LAB+	Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE+	Inline XBRL Taxonomy Extension Presentation Linkbase Document
101.DEF+	Inline XBRL Taxonomy Extension Definition Linkbase Document
104+	Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.*)

+	Exhibits marked with a plus sign (“+”) are filed herewith.
++	Exhibits marked with a double plus sign (“++”) are furnished herewith.
*	Schedules and similar attachments have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company hereby undertakes to furnish on a supplemental basis copies of any of the omitted schedules upon request by the Commission.
^	Certain portions of the exhibit have been omitted pursuant to Rule 601(b)(10) of Regulation S-K. The omitted information is (i) not material and (ii) would likely cause competitive harm to the Company if publicly disclosed.

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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/ Scott D. Myers
	Scott D. Myers
	President and Chief Executive Officer (Principal Executive Officer)
Date:	November 6, 2020
AMAG PHARMACEUTICALS, INC.
By:	/s/ Brian Piekos
	Brian Piekos
	Executive Vice President, Chief Financial Officer and Treasurer (Principal Financial and Accounting Officer)
Date:	November 6, 2020

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EX-10.1

Exhibit 10.1

Portions of this Exhibit have been redacted because they are both (i) not material and (ii) would likely cause competitive harm to the Company if publicly disclosed. Information that was omitted has been noted in this document with a placeholder identified by the mark "[***]".

LICENSE AND COMMERCIALIZATION AGREEMENT

This License and Commercialization Agreement (“Agreement”), effective as of July 23, 2020 (the “Effective Date”), is entered into by and between AMAG Pharmaceuticals Inc., a Delaware corporation (“AMAG Parent”) and Perosphere Pharmaceuticals Inc., a Delaware corporation (“AMAG Subsidiary” and, together with AMAG Parent, collectively “AMAG”),each with a place of business at 1100 Winter Street, Waltham, MA 02451 USA, and Norgine B.V. (“Norgine”), a Dutch corporation with a place of business at Antonio Vivaldistraat 150, 1083 HP Amsterdam, The Netherlands. AMAG and Norgine may be referred to herein individually as a “Party” or collectively as the “Parties.”

Recitals:

A.    AMAG is developing and intends to manufacture, market and distribute the novel pharmaceutical agent, Ciraparantag, for reversal of certain anticoagulants;

B.Norgine is a specialty pharmaceutical company engaged in the development and commercialization of pharmaceutical products; and

C.Norgine and AMAG desire to enter into an arrangement for the development of the Product and, if approved for commercialization, the commercialization of the Product in the Norgine Territory (defined below), all upon the terms and conditions set forth in this Agreement.

In consideration of the foregoing premises and the mutual covenants herein contained, the Parties hereby agree as follows:

Agreement:

1.    Definitions

Unless specifically set forth to the contrary herein, the following capitalized terms, whether used in the singular or plural, shall have the respective meanings set forth below:

1.1    “1974 Convention” has the meaning set forth in Section 15.5.

1.2    “Affiliate” means with respect to any Party, any person or entity controlling, controlled by or under common control with such Party. For purposes of this Section 1.2, “control” means (a) in the case of a corporate entity, direct or indirect ownership of at least fifty percent (50%) or more of the stock or shares having the right to vote for the election of directors of such corporate entity and (b) in the case of an entity that is not a corporate entity, the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such entity, whether through the ownership of voting securities, by contract or otherwise.

1.3    “Agreement” has the meaning set forth in the preamble.

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1.4    “Alliance Manager” has the meaning set forth in Section 2.5.

1.5    “AMAG” has the meaning set forth in the preamble.

1.6    “AMAG Agreements” has the meaning set forth in Section 10.1(e).

1.7    “AMAG Indemnitee(s)” has the meaning set forth in Section 11.1.

1.8    “AMAG Licensed Know-How” means the Know-How that is Controlled by AMAG or any of its Affiliates as of the Effective Date or at any time during the Term, that is: (a) related to the Product and (b) necessary or useful for Norgine to exercise the rights licensed to it pursuant to this Agreement or to perform its obligations under this Agreement with respect to or for the Norgine Territory. The term AMAG Licensed Know-How shall also be deemed to include AMAG’s interest in any Know-How included in AMAG Program IP.

1.9    “AMAG Licensed Patents” means the Patents in the Norgine Territory Controlled by AMAG or any of its Affiliates as of the Effective Date or at any time during the Term that: (a) claim the drug substance, drug product, a method of manufacturing the drug substance or drug product, or a method of use, in each case related to the Product, (b) would be infringed by Developing or Commercializing the Product in the Norgine Territory, or Manufacturing the Product anywhere in the world (to the extent permitted under this Agreement), but for the licenses granted hereunder, or (c) are otherwise necessary or useful for Norgine to Develop and Commercialize the Product in the Norgine Territory, and to Manufacture the Product anywhere in the world (to the extent permitted under this Agreement), in each case in accordance with this Agreement. The AMAG Licensed Patents existing as of the Effective Date are listed in Exhibit A attached hereto. The term AMAG Licensed Patents shall also be deemed to include Patents included in AMAG Program IP.

1.10    “AMAG Licensed Technology” means the AMAG Licensed Patents, the AMAG Licensed Know-How and the AMAG Program IP.

1.11    “AMAG Licensed Trademarks” means any and all Trademarks Controlled by AMAG as of the Effective Date or at any time during the Term, that are registered for or apply to the Product in the Norgine Territory. For clarity, the AMAG Licensed Trademarks do not include the mark “AMAG,” “AMAG Pharmaceuticals”, or associated logos.

1.12    “AMAG Parent”has the meaning set forth in the preamble.

1.13    “AMAG Program IP” has the meaning set forth in Section 12.1(c).

1.14    “AMAG Subsidiary”has the meaning set forth in the preamble.

1.15    “AMAG Territory” means the entire world, other than the Norgine Territory.

1.16    “AMAG Third Party Agreements”means the (i) [***] and (ii) subject to Section 8.1(d), each other license agreement executed after the Effective Date between AMAG and a

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Third Party licensor pursuant to which AMAG in-licenses intellectual property from such Third Party that is included within the AMAG Licensed Technology.

1.17    “Ancillary Agreements” has the meaning set forth in Section 5.2.

1.18    “Annual Net Sales” shall mean the Net Sales generated over any given Calendar Year.

1.19    “Anti-Corruption Laws” means the U.S. Foreign Corrupt Practices Act, as amended, the UK Bribery Act 2010, as amended, and any other applicable anti-corruption laws and laws for the prevention of fraud, racketeering, money laundering or terrorism, including those within the Norgine Territory.

1.20    “Applicable Laws and Regulations” means all international, national, federal, state, regional, provincial, municipal and local government laws, rules, and regulations that apply to either Party or to the conduct of activities under this Agreement including good clinical practices, and the laws, rules and regulations of the United States and the Norgine Territory, and International Conference on Harmonisation guidelines, each as may be then in effect, as applicable and amended from time to time.

1.21    “Bankruptcy Code” has the meaning set forth in Section 8.7.

1.22    “Business Acquisition” has the meaning set forth in Section 4.6(c).

1.23    “Business Combination” means with respect to a Party, any of the following events: (a) any Third Party (or group of Third Parties acting in concert) acquires, directly or indirectly, shares of such Party representing fifty percent (50%) or more of the voting shares (where voting refers to being entitled to vote for the election of directors) then outstanding of such Party; (b) such Party consolidates with or merges into another corporation or entity which is a Third Party, or any corporation or entity which is a Third Party consolidates with or merges into such Party, in either event pursuant to a transaction in which more than fifty percent (50%) of the voting shares of the acquiring or resulting entity outstanding immediately after such consolidation or merger is not held by the holders of the outstanding voting shares of such Party immediately preceding such consolidation or merger; or (c) such Party conveys, transfers or leases all or substantially all of its assets to a Third Party.

1.24    “Business Day” means a day on which banking institutions in Boston, MA, USA and Amsterdam, the Netherlands are open for business, excluding any Saturday or Sunday.

1.25    “Business Party” has the meaning set forth in Section 4.6(c).

1.26    “Business Program” has the meaning set forth in Section 4.6(c).

1.27    “Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31, provided that, the first Calendar Quarter begins on the Effective Date and ends on September 30, 2020.

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1.28    “Calendar Year” means the respective periods of twelve (12) months commencing on January 1 and ending on December 31, provided that, the first Calendar Year begins on the Effective Date and ends on December 31, 2020.

1.29    “Clinical Data” means all data generated or arising from the conduct of a clinical trial or other Development efforts under this Agreement.

1.30    “Clinical Supply Agreement” has the meaning set forth in Section 5.2.

1.31    “CMC” means chemistry, manufacturing, and controls.

1.32    “CMO Agreement” has the meaning set forth in Section 5.1.

1.33    “Combination Product” means a commercial product comprising the Product plus one or more other therapeutically active ingredients, whether co-formulated or co-packaged.

1.34    “Commercialization” or “Commercialize” means activities taken before and after obtaining Regulatory Approval relating specifically to the pre-launch, launch, promotion, marketing, sales force recruitment, sale and distribution of a pharmaceutical product and post-launch medical activities, including: (a) distribution for commercial sale; (b) strategic marketing, sales force detailing, advertising, and market and product support; (c) medical education and liaison and any Regulator-Requested Trials, to the extent permitted by this Agreement; (d) all customer support and product distribution, invoicing and sales activities; and (e) all post-approval regulatory activities, including those necessary to maintain Regulatory Approvals.

1.35    “Commercially Reasonable Efforts” means with respect to the efforts to be expended by a Party with respect to any objective under this Agreement, [***], it being understood and agreed that with respect to the Development or Commercialization of the Product, such efforts shall be [***].

1.36    “Commercial Supply Agreement” has the meaning set forth in Section 5.2.

1.37    “Competitive Infringement” has the meaning set forth in Section 12.5(b)(ii).

1.38    “Competitive Product” means any agent that reverses, reduces, or otherwise inhibits the effects of one or more of the following anticoagulants [***]: rivaroxaban, apixaban, edoxaban and/or enoxaparin sodium injection.

1.39    “Confidential Information” means any and all non-public scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, financial and commercial information and data, in any tangible or intangible form, including all Know-How subject to Article 9.

1.40    “Control,” “Controls” or “Controlled by” means (except as used in Section 1.2), with respect to any item of or right under Patents, Know-How, Trademarks, Regulatory Submissions, or Regulatory Approvals, in the possession of a Party (whether through ownership, license or sublicense, other than by a license, sublicense or other right granted (but not assignment) pursuant to this Agreement) and to which such Party has the right and authority to

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grant access to, or a license or sublicense of, such item or right as provided for in this Agreement without violating the terms of any agreement or other arrangement with any Third Party existing at the time such Party would be required hereunder to grant the other Party such access or license or sublicense.

1.41    “Develop” or “Development” or “Developing” means research, discovery, and preclinical and clinical drug or biological development activities, including toxicology, formulation, statistical analysis, preclinical and clinical studies, post-approval clinical trial and regulatory affairs, approval and registration, in each case, of products in the Field.

1.42    “Development Costs” means, as to the Product, the actual and reasonable out-of-pocket costs and expenses incurred in connection with conduct of the Phase 3 Program, including [***].

1.43    “Development Plan” has the meaning set forth in Section 2.1(a).

1.44    “Dispute” means any dispute, claim, or controversy (other than matters with respect to which a Party has final decision-making authority hereunder or matters that are expressly stated herein to require the consent of both Parties) arising from or related to this Agreement or to the interpretation, application, breach, termination, or validity of this Agreement, including any claim of inducement of this Agreement by fraud or otherwise.

1.45    “Distributor” means a Third Party bona fide wholesaler or distributor to whom Norgine or its Affiliates or its or their Sublicensees grants a right to market, sell or distribute the Product in a particular jurisdiction, that purchases its requirements for such Product from Norgine or its Affiliates or its or their Sublicensees, and does not otherwise make any upfront, royalty or other payments to Norgine or its Affiliates or its or their Sublicensees with respect to the Product (other than the purchase price for the Product), including any payments that are calculated on the basis of a percentage of, or profit share on, such Third Party’s sale of Products.

1.46    “Dollars” or “$” means United States Dollars, the lawful currency of the United States.

1.47    “Effective Date” has the meaning set forth in the preamble.

1.48    “EMA” shall mean the European Medicines Agency, or any successor agency thereto.

1.49    “Euros” or “€” means the single currency shared by certain member states of the European Union and the lawful currency of the Netherlands. In the event the Euro ceases to exist in its current form, references to “Euros” or “€” shall automatically be substituted by whichever currency is adopted by the Netherlands, provided that any specific amounts denominated in Euros in this Agreement shall be converted to such substitute currency at the then applicable published exchange rate and, if no such exchange rate then exists, the Parties will agree upon an exchange rate for such conversion in good faith.

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1.50    “Executive Officer” means, with respect to either Party, the Chief Executive Officer of such Party (or his or her designee).

1.51    “Existing CDA” has the meaning set forth in Section 15.6.

1.52    “FDA” means the United States Food and Drug Administration, or any successor agency thereto.

1.53    “Field” means all human fields of use (including treatment and diagnosis).

1.54    “First Commercial Sale” means the first sale of the Product to a Third Party for end use or consumption in any country in the Norgine Territory after any required Regulatory Approvals for the Product have been obtained in such country in the Norgine Territory. For avoidance of doubt, in no event will any sale or distribution of a Product for use in a clinical trial or any sales prior to receipt of such required Regulatory Approval (including so called “treatment IND sales”, “named patient sales” and “compassionate use sales”) be deemed a First Commercial Sale.

1.55    “Force Majeure” has the meaning set forth in Section 15.1.

1.56    “Fully Burdened Manufacturing Cost” or “FBMC” means, with respect to the Product supplied by or on behalf of AMAG or its Affiliates under the Supply Agreements, [***], all in accordance with U.S. Generally Accepted Accounting Principles then in effect.

1.57    “Government Official” has the meaning set forth in Section 4.8(c).

1.58    “Indemnified Party” has the meaning set forth in Section 11.3(a).

1.59    “Indemnification Claim Notice” has the meaning set forth in Section 11.3(a).

1.60    “Indemnifying Party” has the meaning set forth in Section 11.3(a).

1.61    “Indemnitee” means either the Norgine Indemnitee or the AMAG Indemnitee, as applicable.

1.62    “ISR”means investigator sponsored research.

1.63    “JDC” has the meaning set forth in Section 2.1(a).

1.64    “Joint Amendment” has the meaning set forth in Section 2.4(d).

1.65    “JSC” has the meaning set forth in Section 2.2.

1.66    “Know-How” means (a) any proprietary scientific or technical information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including databases, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, medicinal chemistry,

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biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, and manufacturing process and development information, results and data and (b) any proprietary biological, chemical or physical materials; in each case whether or not patentable. Know-How excludes Patents.

1.67    “Licensing Transaction” has the meaning set forth in Section 9.3(d)(ii)(C).

1.68    “Licensees” means any Third Party that is granted a license by AMAG or any of its Affiliates under the AMAG Licensed Technology or any other patents, patent applications, Know-How or other intellectual property Controlled by AMAG or any of its Affiliates, relating to the Product, including the Development or Commercialization of the Product.

1.69    “Litigation Conditions” has the meaning set forth in Section 11.3(b).

1.70    “Losses” has the meaning set forth in Section 11.1.

1.71    “MAA” means (a) a market authorization application filed with the EMA for marketing approval of the Product or any successor applications or procedures, and all supplements and amendments that may be filed with respect to the foregoing, or similar filings outside the Norgine Territory with applicable Regulatory Authorities, for approval to commercially market, import and sell the Product, or (b) similar filings in the Norgine Territory with applicable Regulatory Authorities, including country-specific Regulatory Authorities, for approval to commercially market, import and sell the Product. The term MAA shall exclude pricing and reimbursement approvals.

1.72    “Major European Countries” means Germany, France, UK, Italy and Spain.

1.73    “Major Safety Issue” means, with respect to the Product, any of the following: (a) an adverse safety profile of the Product, or receipt or generation by a Party of any safety, tolerability or other data, indicating or signaling, as measured by safety and efficacy evaluation criteria and methodology customarily used by a majority of clinicians conducting studies on similar products in the applicable region or country, that the Product has or would have serious enough risks for medical applications in humans to require a recall, withdrawal, or similar action; or (b) any notice, information or correspondence received by a Party from a Regulatory Authority, or any action taken by a Regulatory Authority, in each case, that would reasonably be expected to result in Regulatory Approval not being granted therefor or, if already granted, the Regulatory Approval therefor being revoked or materially and adversely amended, or causes the Regulatory Approval therefor not to be granted or, if already granted, to be revoked or materially and adversely amended.

1.74    “Manufacture” or “Manufacturing” means all operations involved in the manufacturing (including process development activities and associated regulatory support, quality assurance and quality control testing (including test method development and in-process, release and stability testing, if applicable), technical transfer activities, storage, releasing, packaging and importation of the Product. For purposes of clarification “Manufacturing” is not included in Development or Commercialization.

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1.75    “Manufacturing Expert Advice Draft” has the meaning set forth in Section 5.3(a).

1.76    “Manufacturing Transition Event” has the meaning set forth in Section 5.6.

1.77    “Material Amendment” has the meaning set forth in Section 2.4(a).

1.78    “MHRA” means the Medicines and Healthcare Products Regulatory Agency, and any successor agency thereof.

1.79    “NDA” means New Drug Application (as more fully described in U.S. 21 C.F.R. Parts 314.50 et seq. or its successor regulation) and all amendments and supplements thereto, submitted to the FDA.

1.80    “Net Sales” means the gross amount invoiced for the Product sold by Norgine or its Related Parties in the Norgine Territory initially and directly to Third Parties which are not Related Parties less the following deductions actually incurred, allowed, paid, accrued or specifically allocated in its financial statements:

(a)    [***]

(b)    [***]

(c)    [***]

(d)    [***]

(e)    [***]

Such amounts shall be determined from the books and records of Norgine or its Related Party, maintained in accordance with International Financial Reporting Standards (IFRS) or such similar accounting principles, consistently applied. Norgine further agrees, in determining such amounts, it shall use Norgine’s then-current standard procedures and methodology. [***].

[***].

If non-monetary consideration is received for sales of the Product in any country in the Norgine Territory in any Calendar Quarter, Net Sales from such sales will be calculated based on the average price per unit sold of the Product in such country during such Calendar Quarter, or in the absence of such sales, the fair market value per unit sold of the Product for use in such country, as determined by the Parties in good faith.

1.81    “Neutral Development Expert” has the meaning set forth in Section 3.2(c)

1.82    “Neutral ManufacturingExpert” has the meaning set forth in Section 5.3(b).

1.83    “Norgine” has the meaning set forth in the preamble.

1.84    “Norgine Controlled Trademark” has the meaning set forth in Section 12.7(c).

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1.85    “Norgine Cost Share” has the meaning set forth in Section 3.2.

1.86    “Norgine Indemnitees” has the meaning set forth in Section 11.2.

1.87    “Norgine In-License” has the meaning set forth in Section 8.3.

1.88    “Norgine Licensed Know-How” means all Know-How Controlled by Norgine or any of its Affiliates as of the Effective Date or at any time during the Term that is: (a) related to the Product; and (b) incorporated or used by Norgine in connection with the Development or Commercialization of the Product in the Norgine Territory; and (c) necessary or useful for AMAG to exercise the rights retained by it under this Agreement or perform its obligations under this Agreement, including with respect to AMAG’s Development of the Product and AMAG’s Commercialization of the Product in and for the AMAG Territory, and to Manufacture the Product anywhere in the world. The term Norgine Licensed Know-How shall also be deemed to include Norgine’s interest in any Know-How included in Norgine Program IP.

1.89    “Norgine Licensed Patents” means any and all Patents Controlled by Norgine or any of its Affiliates as of the Effective Date or at any time thereafter during the Term that are related to any data, result or invention conceived, created or reduced to practice in the course of conducting activities pursuant to this Agreement solely by or on behalf of Norgine specifically in relation to the Product and that are necessary or useful for AMAG to Develop or Commercialize the Product in the AMAG Territory, or to Manufacture the Product anywhere in the world, in accordance with this Agreement. The term Norgine Licensed Patents shall be deemed to include Patents included in Norgine Program IP.

1.90    “Norgine Program IP” has the meaning set forth in Section 12.1(c).

1.91    “NorgineTerritory” means Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Republic of Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, UK, Switzerland, Albania, Serbia, Montenegro, Kosovo, Bosnia and Herzegovina, Macedonia, Norway, Iceland, Australia and New Zealand, and all territories and possessions of any of the foregoing.

1.92    “Party Representatives” has the meaning set forth in Section 4.8(a).

1.93    “Patent(s)” means any and all: (a) patents and any extensions or applications for extensions of any of the foregoing; (b) pending patent applications, including all provisional applications, continuations, continuations-in-part, divisions, reissues, renewals, and all patents granted thereon, and any extensions or applications for extensions of any of the foregoing; (c) patents-of-addition, reissue patents, re-examinations and extensions or restorations by existing or future extension or restoration mechanisms; (d) supplementary protection certificates (and applications thereof), pending supplementary protection certificates, and any extensions or applications for extensions of any of the foregoing or the equivalent thereof; and (e) equivalents of any of the foregoing in any jurisdiction.

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1.94    “Patent Defense” means the responsibility for defending any Patent against any Third Party invalidity challenges that are not included within Patent Prosecution, excluding any such invalidity challenges asserted as a defense in a proceeding to enforce such Patent.

1.95    “Patent Prosecution” means the responsibility for (a)preparing, filing, prosecuting, and pursuing registration of, applications (of all types) for any Patent, (b) for maintaining any Patent, and (c)for controlling any post-grant proceeding relating to any Patent, including, but not limited to, interference, opposition, reissue, ex-partes and inter-partes re-examination, inter-partes review, post-grant review, and supplemental examination.

1.96    “Patent Prosecution and Defense” means Patent Prosecution and Patent Defense.

1.97    [***].

1.98    “Perosphere Merger Agreement” means the Agreement and Plan of Merger by and among AMAG, Magellan Merger Sub, Inc., Perosphere Pharmaceuticals Inc., and Bryan E. Laulicht, dated December 12, 2018.

1.99    “[***]” has the meaning set forth in Section 6.2(a).

1.100    “Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, a government or political subdivision, or any department or agency of a government.

1.101    “Phase 3 Budget” means a [***] budget for the Phase 3 Program that is included within the Development Plan, and shall include Development Costs for the Phase 3 Program.

1.102    “Phase 3 Budget Expert Advice Draft” has the meaning set forth in Section 3.2(c)(i).

1.103    “Phase 3 Clinical Trial” means a human clinical trial of a product in any country that is intended to (a) establish that the product is safe and efficacious for its intended use, (b) define contraindications, warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed, and (c) support Regulatory Approval for such product with the FDA, EMA and MHRA.

1.104    “Phase 3 Program” means (a) the Pivotal Clinical Trial, (b) any additional Phase 3 Clinical Trials required to support the filing for Regulatory Approval of the Product with the FDA, the EMA and the MHRA and (c) a human clinical trial intended to confirm the dose of the Product in reversing, reducing, or otherwise inhibiting the effects of edoxaban for use in the Pivotal Clinical Trial. A Phase 3 Clinical Trial that is conducted solely to meet country-specific requirements for Regulatory Approval in such country (i.e., a Regulator-Requested Trial) shall not be considered to be part of the Phase 3 Program.

1.105    “Pivotal Clinical Trial”means a clinical trial that is intended

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to be sufficient to support the filing for Regulatory Approval with the FDA, the EMA and the MHRA, [***].

1.106    “Product” means (a) the novel pharmaceutical agent, Ciraparantag, which contains the active pharmaceutical ingredient, 1,4-Bis(arginine-3-aminopropyl)-piperazine, acetate salt (ciraparantag) [***].

1.107    “Product Liabilities” has the meaning set forth in Section 11.4(a).

1.108    “Publishing Party” has the meaning set forth in Section 9.2(b).

1.109    “Regulator-Requested Trial”has the meaning set forth in Section 3.1(b).

1.110    “Regulatory Approval” means the approval of the applicable Regulatory Authority necessary for the marketing and sale of a pharmaceutical product in a country, excluding separate pricing or reimbursement approvals that may be required.

1.111    “Regulatory Authority” means any applicable government regulatory authority involved in granting approvals for the conduct of clinical trials or the manufacturing, marketing, reimbursement or pricing, as applicable, of the Product, including in the United States, the FDA and in the European Union, the EMA, and in the United Kingdom, the MHRA, and any successor governmental authority having substantially the same function.

1.112    “Regulatory Exclusivity” means, with respect to the Product in a country in the Norgine Territory, that (a) Norgine or any of its Affiliates or Sublicensees has been granted the exclusive legal right by a Regulatory Authority (or is otherwise entitled to the exclusive legal right by operation of Applicable Laws and Regulations) in such country to market and sell the Product or the active ingredient comprising the Product in such country, or (b) the data and information submitted by Norgine or any of its Affiliates or Sublicensees to the relevant Regulatory Authority in such country for purposes of obtaining Regulatory Approval may not be disclosed, referenced or relied upon in any way by such Regulatory Authority (including by relying upon the Regulatory Authority’s previous findings regarding the safety or effectiveness of the Product) to support the Regulatory Approval or marketing of any product by a Third Party in such country.

1.113    “Regulatory Milestone Event” has the meaning set forth in Section 6.2(a).

1.114    “Regulatory Milestone Payment” has the meaning set forth in Section 6.2(a).

1.115    “Regulatory Submissions” means any filing, application, or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including MAAs, NDAs, and Regulatory Approvals, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to the Product.

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1.116    “Reimbursable IP Costs” has the meaning set forth in Section 12.3(c).

1.117    “Related Party” means, with respect to a Party, its Affiliates, Licensees, and Sublicensees.

1.118    “Requesting Party” has the meaning set forth in Section 7.2(a).

1.119    “Reviewing Party” has the meaning set forth in Section 9.2(b).

1.120    “Royalty Term” means, with respect to sales of the Product in the Norgine Territory, on a country-by-country basis, the time period beginning on the First Commercial Sale of the Product in such country in the Norgine Territory and expiring on the latest to occur of [***].

1.121    “Sales Milestone Event” has the meaning set forth in Section 6.3(a).

1.122    “Sales Milestone Payment” has the meaning set forth in Section 6.3(a).

1.123    “Sublicensee” means a Third Party that is granted a sublicense under the licenses granted to a Party under this Agreement, as permitted under this Agreement, excluding Distributors.

1.124    “Supply Agreements” has the meaning set forth in Section 5.2.

1.125    “Supply Disruption” means (a) AMAG fails to deliver at least in the aggregate [***] of Product ordered by Norgine in a [***] period, [***], provided that (x) Norgine provides written notice to AMAG and demonstrates [***] as a result of such non-conforming batches, and (y) Norgine returns such batches in full, destroys such batches or otherwise acts in accordance with the reasonable instructions of AMAG.

1.126    “Technology Transfer” has the meaning set forth in Section 5.6.

1.127    “Term” has the meaning set forth in Section 14.1.

1.128    “Third Party” means a Person other than (a) Norgine and its Affiliates, and (b) AMAG and its Affiliates.

1.129    “Third Party Patent Right” has the meaning set forth in Section 8.3.

1.130    “Third Party Products Liability Action” has the meaning set forth in 11.4(b).

1.131    “Trademark(s)” means all trade names, logos, unregistered trademarks and service marks, trademark and service mark registrations and applications throughout the world.

1.132    “Trademark Defense” means the responsibility for defending any Trademark against any Third Party invalidity challenges that are not included within Trademark Prosecution, excluding any such invalidity challenges asserted as a defense in a proceeding to enforce such Trademark.

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1.133    “Trademark Prosecution” means the responsibility for (a)preparing, filing, and seeking registration of, trademark applications (of all types) for any Trademark, (b) for maintaining any Trademark, and (c)for controlling any opposition proceeding relating to the foregoing.

1.134    “Trademark Prosecution and Defense” means Trademark Prosecution and Trademark Defense.

1.135    “United States” or “U.S.” means the United States of America and its territories and possessions, including the Commonwealth of Puerto Rico and the U.S. Virgin Islands.

1.136    “Valid Claim” means a claim of: (a) an issued and unexpired Patent included within the AMAG Licensed Patents in a country of the Norgine Territory which has not been revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and has not been abandoned, disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise; or (b) a pending patent application (which has been pending for [***] or less from the date of filing of the earliest priority patent application to which such pending patent application is entitled to claim benefit) that has been filed in good faith and that has not been cancelled, withdrawn, or abandoned; provided that, if a claim in a patent application is no longer a Valid Claim pursuant to clause (b) due to a pendency period that is longer than [***], but such claim subsequently becomes an issued claim under clause (a), then such claim will again be a Valid Claim.

2.    Governance

2.1    Joint Development Committee. The Parties hereby establish a joint development committee (the “JDC”), to coordinate and oversee the Development of the Product in the Norgine Territory before Regulatory Approval therein. The JDC shall consist of [***] representatives from each Party. The Parties shall ensure that each of their representatives on the JDC shall have knowledge and on-going familiarity with the Product, this Agreement and the activities hereunder, and shall be of suitable seniority and possess the authority to make decisions reserved to the JDC. AMAG shall designate [***] of its representatives as the initial chairperson of the JDC. The chairperson of the JDC shall alternate between the Parties on an annual basis. Each Party may replace its appointed JDC representatives at any time upon reasonable written notice to the other Party. The initial representatives and chair of the JDC shall be established within [***] after the Effective Date. The chair, in conjunction with the Alliance Managers, shall have the responsibility to call meetings, circulate meeting agendas at least [***] prior to each regular JDC meeting, draft minutes for each JDC meeting and circulate such minutes for both Parties’ written approval. The chair shall have no other authority or special voting power. The JDC may, in its discretion, form sub-teams or subcommittees to address any of the issues within its purview.

(a)    Responsibilities of the JDC. The JDC shall have the following responsibilities:

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(i)    the general strategy and budget for the Development of the Product, including for seeking and obtaining Regulatory Approval of the Product in the Norgine Territory, pursuant to the global development plan for the Phase 3 Program attached hereto as Exhibit B, which shall be reviewed and updated [***] by the JDC (as amended from time to time, the “Development Plan”), and agreeing to the Phase 3 Budget;

(ii)    alignment on protocol and strategy for the Pivotal Clinical Trial, and determining whether to suspend or terminate the Pivotal Clinical Trial if (A) a priori protocol defined stopping rules are met for safety or efficacy, (B) safety signals are observed by either Party that such Party believes present an unacceptable risk to patients participating in the Pivotal Clinical Trial or (C) if applicable, the data and safety monitoring board overseeing the Pivotal Clinical Trial determines the Product presents an unacceptable risk to patients participating in the Pivotal Clinical Trial; provided that any decision of the JDC with respect to suspension or termination of the Pivotal Clinical Trial for safety reasons will be reviewed in a timely manner with the applicable Regulatory Authorities to obtain the opinion of such Regulatory Authorities whether such safety reasons justify suspension or termination of the Pivotal Clinical Trial;

(iii)    review and monitor progress of the Development activities (including any related clinical trials and any other material results thereunder) and the Parties’ activities under the Development Plan, including serving as a forum for exchanging information and facilitating discussions regarding the conduct of the Development Plan;

(iv)    review and approval of the protocol for any Regulator-Requested Trial;

(v)    review and discuss regulatory activities with respect to the Products (including discussing coordination of such activities in the Parties’ respective territories);

(vi)    review of any scientific or safety concerns of a Party which such Party reasonably believes might impact such Party’s Development of the Product;

(vii)    discuss such other information relating to the Products that is reasonably requested by either Party;

(viii)    discuss and coordinate the Manufacturing and supply of the Product for the Norgine Territory, including (A) developing plans for Manufacturing and supply of the Product for Development or Commercialization in the Norgine Territory, (B) selecting contract manufacturing organizations or other Third Party contractors to be involved in the Manufacture or supply of the Product for Development or Commercialization in the Norgine Territory, and (C) establishing the target FBMC for the Product supplied for Commercialization in the Norgine Territory no later than [***];

(ix)    serve as the first forum for discussing disputes or disagreements resulting from, arising out of or in relation to Development or Manufacture of the Products in the Parties’ respective territories;

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(x)    coordinate the sharing and exchange of information necessary or useful for each Party to perform its obligations under this Agreement, including the information exchanged pursuant to Sections 3.1(d) and 3.1(e); and

(xi)    have such additional responsibilities as may be assigned to the JDC pursuant to this Agreement or as may be mutually agreed upon by the Parties in writing from time to time.

(b)    JDC Meetings. JDC meetings shall be held [***], or on any other schedule mutually agreed by the Parties. With the consent of the representatives of each Party serving on the JDC, other representatives of each Party may attend meetings as non-voting observers (provided such non-voting observers have confidentiality obligations to such Party that are at least as stringent as those set forth in this Agreement). A JDC meeting may be held either in person or by audio, video or internet teleconference with the consent of each Party. Meetings of the JDC shall be effective only if at least [***] representative of each Party is present or participating. [***]. The Parties shall alternate hosting the in-person meeting, and the Party hosting is responsible for preparing and circulating the minutes of the JDC meetings.

(c)    Duration of JDC. The JDC shall continue to exist until the first to occur of (i) [***], (ii) the Parties mutually agreeing in writing to disband the JDC or (iii) termination of this Agreement in accordance with the terms hereof.

(d)    Limitations. The JDC shall have no authority other than that expressly set forth in this Article 2 and, specifically, shall have no authority (i) to amend, modify or waive compliance with any term or condition of this Agreement or make any decision inconsistent with any term or condition of this Agreement, (ii) to determine whether or not a breach of this Agreement has occurred or that a Party has fulfilled any obligations under this Agreement; (iii) alter, increase or expand the Parties’ rights or obligations under this Agreement beyond those explicitly set forth in this Agreement; (iv) make any decision that is expressly stated to require the mutual agreement of the Parties or the consent of a specified Party; or (v) resolve any claim or dispute regarding whether or in what amount a payment is owed under this Agreement.

2.2    Joint Steering Committee. The Parties hereby establish a joint steering committee (the “JSC”), to oversee the Parties’ activities under this Agreement, to coordinate and oversee the Commercialization (including pre-launch commercial activities) of the Product by the Parties in their respective territories and any additional Development work to be conducted by the Parties after dissolution of the JDC pursuant to Section 2.1(c), and to resolve any disputed matters within the purview of the JDC that are referred to the JSC for resolution. The JSC shall consist of [***] representatives from each Party. The Parties shall ensure that each of their representatives on the JSC shall have knowledge and on-going familiarity with the Product, this Agreement and the activities hereunder, and shall be of suitable seniority and possess the authority to make decisions reserved to the JSC. AMAG shall designate [***] of its representatives as the initial chairperson of the JSC. The chairperson of the JSC shall alternate between the Parties on an annual basis. Each Party may replace its appointed JSC representatives at any time upon reasonable written notice to the other Party. The initial representatives and chair of the JSC shall be established within [***] after the Effective Date. The

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chair, in conjunction with Alliance Managers, shall have the responsibility to call meetings, circulate meeting agendas at least [***] prior to each regular JSC meeting, draft minutes for each JSC meeting and circulate such minutes for both Parties’ written approval. The chair shall have no other authority or special voting power. The JSC may, in its discretion, form sub-teams or subcommittees to address any of the issues within its purview.

(a)    Purview of the JSC. The JSC shall have responsibilities for activities performed under this Agreement to the extent expressly and as more specifically provided herein. In addition to oversight of the JDC, the JSC shall discuss and seek to coordinate on the following topics, subject to Applicable Laws and Regulations:

(i)    the general strategy for pricing and reimbursement approval of the Product in the Parties’ respective territories;

(ii)    pre-launch Commercialization activities and subsequent Commercialization activities, in each case, in the Norgine Territory;

(iii)    each Party’s free goods and compassionate use policy with respect to the Product for its respective territory, and such Party’s implementation of such policy;

(iv)    positioning and branding strategy for the Product for each Party’s Territory, including such Party’s strategies with respect to regional or local publications and Trademarks;

(v)    each Party’s plans and strategies with respect to such Party’s presence at international congresses and conventions and other medical education activities;

(vi)    resolution of any disputes with respect to any ISR proposed by a Party that the other Party reasonably believes will be detrimental to the global brand, or the Development or Commercialization of the Product in such Party’s territory; and

(vii)    review of any items previously governed by the JDC if and when the JDC is dissolved pursuant to Section 2.1(c).

(b)    JSC Meetings. JSC meetings shall be held [***], or on any other schedule mutually agreed by the Parties. With the consent of the representatives of each Party serving on the JSC, other representatives of each Party may attend meetings as non-voting observers (provided such non-voting observers have confidentiality obligations to such Party that are at least as stringent as those set forth in this Agreement). A JSC meeting may be held either in person or by audio, video or internet teleconference with the consent of each Party. Meetings of the JSC shall be effective only if at least [***] representative of each Party is present or participating. [***]. The Parties shall alternate hosting the in-person meeting, and the Party hosting is responsible for preparing and circulating the minutes of the JSC meetings.

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(c)    Duration of JSC. The JSC shall continue to exist until the first to occur of (i) the Parties mutually agreeing in writing to disband the JSC or (ii) termination of this Agreement in accordance with the terms hereof.

(d)    Limitations. The JSC shall have no authority other than that expressly set forth in this Section 2.2 and shall not have any authority (i) to amend, modify or waive compliance with any term or condition of this Agreement or make any decision inconsistent with any term or condition of this Agreement, (ii) to determine whether or not a breach of this Agreement has occurred or that a Party has fulfilled any obligations under this Agreement; (iii) alter, increase or expand the Parties’ rights or obligations under this Agreement beyond those explicitly set forth in this Agreement; (iv) make any decision that is expressly stated to require the mutual agreement of the Parties or the consent of a specified Party; or (v) resolve any claim or dispute regarding whether or in what amount a payment is owed under this Agreement.

2.3    Decision-Making.

(a)    JDC. JDC decisions shall be made by unanimous consent, with each Party’s representatives collectively having one (1) vote. In the event the JDC is unable to reach agreement on any matter, after using good faith efforts to resolve such matter, the matter shall be referred to the JSC.

(b)    JSC. JSC decisions shall be made by unanimous consent, with each Party’s representatives collectively having one (1) vote. In the event the JSC is unable to reach agreement on any matter (including any deadlocks at the JSC), after using good faith efforts to resolve such matter, the matter shall be referred to the Executive Officers for consideration and resolution in accordance with Section 13.2. If the Executive Officers are unable to resolve such matter as set forth in Section 13.2, then the Party having final decision-making authority over such matter pursuant to Section 2.3(c) shall decide such matter.

(c)    Final Decision-Making Authority. Subject to Sections 2.4 and 2.2(d):

(i)    AMAG. AMAG shall have final decision-making authority with respect to all matters concerning: [***] .

(ii)    Norgine. Norgine shall have final decision-making authority with respect to all matters concerning [***].

(iii)    In each case the Party with final decision-making authority (A) will [***] the recommendations and concerns raised by the other Party; (B) will make such decisions in good faith using [***]; (C) will not exercise its final decision-making authority in a manner that would require the other Party to perform any act that the other Party reasonably believes would violate Applicable Laws or Regulations or infringe, misappropriate or violate the Patents or Know-How of a Third Party; and (C) will not otherwise [***] beyond those explicitly set forth in this Agreement.

2.4    Material Amendments to Development Plan.

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(a)    Either Party may, from time to time, propose amendments to the Development Plan (any amendment that would result in an increase in cost to the other Party exceeding [***] of the Development Costs [***], including changes to the Pivotal Clinical Trial, a “Material Amendment”).

(b)    If a Material Amendment is approved by unanimous consent of the JDC pursuant to Section 2.2, (A) the Development Plan shall be amended to include such Material Amendment and (B) the Parties shall share in the payment of costs incurred in connection with the activities under such Material Amendment in accordance with Section 3.2.

(c)    If a Material Amendment proposed by Norgine is not approved by the JDC pursuant to Section 2.2 then the Development Plan shall not be amended. If a Material Amendment proposed by AMAG is not approved by the JDC pursuant to Section 2.2, then AMAG may proceed with the activities described in the proposed amendment [***], provided that AMAG shall consider any reasonable, good faith concerns timely raised by Norgine in good faith.

(d)    Notwithstanding anything to the contrary in Section 2.4(c), (i) if the FDA, EMA, or MHRA requires a change to the Phase 3 Program, [***] (such amendment in this clause (ii), a “Joint Amendment”).

2.5    Alliance Managers. Each Party will designate in writing within [***] after the Effective Date an “Alliance Manager” to be the primary contact for such Party. The Alliance Manager will be responsible for managing communications between the Parties with respect to activities under this Agreement, including responsibility with the chairperson for scheduling teleconferences and calling and coordinating JSC and JDC meetings, circulating meeting agendas, and drafting and circulating minutes for JSC and JDC meetings. Alliance Managers may also be members of the JDC, and may attend meetings of the JSC as observers. In no event will the Alliance Managers have the power to amend or waive compliance with this Agreement.

3.    Development and Regulatory Matters

3.1    Development Responsibilities. The Parties acknowledge and agree that coordination between them on Development of the Product is desirable for maximizing the value of the Product, and therefore that the Parties will exchange relevant information to each Party’s and/or its Licensees’ and Sublicensees’ Development strategy in a transparent manner as provided in this Agreement.

(a)    AMAG. As between the Parties, subject to Section 3.1(b), AMAG shall be responsible for the worldwide Development of the Product, including the conduct of the Pivotal Clinical Trial, as set forth in the Development Plan. AMAG shall use Commercially Reasonable Efforts to conduct all Development activities set forth in the Development Plan, including the Pivotal Clinical Trial (consistent with the protocol therefor) and other activities set forth therein related to the Phase 3 Program. Failure or refusal by AMAG to use Commercially Reasonable Efforts to conduct the Pivotal Clinical Trial (consistent with the protocol therefor)

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and other material activities set forth in the Development Plan related to the Phase 3 Program shall be considered a material breach of this Agreement by AMAG.

(b)    Norgine. Notwithstanding Section 3.1(a), if a Regulatory Authority in the Norgine Territory requests or requires the conduct of a clinical trial of the Product, subsequent or ancillary to, or in conjunction with the Pivotal Clinical Trial, as a condition of Regulatory Approval or separate pricing and reimbursement approval for the Product, or otherwise requests or requires a subsequent clinical trial for any reason following Regulatory Approval of the Product (such trial a “Regulator-Requested Trial”), Norgine shall be solely responsible for using Commercially Reasonable Efforts to perform such Regulator-Requested Trial(s) [***]. Failure or refusal by Norgine to use Commercially Reasonable Efforts to conduct a Regulator-Requested Trial requested by a Regulatory Authority in any Major European Country shall be considered a material breach of this Agreement by Norgine with respect to such Major European Country. In the event that Norgine is required to perform any Regulator-Requested Trials pursuant to this Section 3.1(b), upon written request by Norgine, AMAG shall [***], in accordance with and subject to the terms set forth therein, in order to make Devices [***] available for Norgine to purchase and use in a Regulator Requested Trial, to the extent reasonably necessary for Norgine to conduct such Regulator-Requested Trial.

(c)    Updates. Each Party shall provide and shall cause its Affiliates to provide, and shall use Commercially Reasonable Efforts to cause its Licensees and Sublicensees (as applicable) to provide, to the JDC quarterly, an update regarding Development activities conducted by or on behalf of such Party with respect to the Product (including in a slide deck, or in other written materials (which may be delivered in electronic format), including safety concerns and study reports and data generated from Clinical Trials of the Product which are relevant to Development activities then being conducted or proposed to be conducted by the other Party in such other Party’s territory). In addition, each Party shall promptly share with the other Party through discussions at the JDC all material developments and information that it Controls relating to Development of the Product. Further, AMAG shall promptly share with Norgine through discussions at the JDC any material research or Development activities engaged in by AMAG or any of its Affiliates relating to Ciraparantag [***].

(d)    Data Transfer. Within [***] after the Effective Date, AMAG shall transfer in their then-current format to Norgine all Regulatory Submissions Controlled by AMAG or its Affiliates that are necessary or reasonably useful for Norgine to conduct its Development activities and to perform its obligations or exercise its rights hereunder. The JDC shall discuss and determine what AMAG Licensed Know-How is necessary or reasonably useful for Norgine to conduct its Development activities and to perform its obligations or exercise its rights hereunder, and coordinate timeline for the transfer of such AMAG Licensed Know-How. The Parties acknowledge that AMAG may be requested to certify certain elements of the data of AMAG and its Affiliates for official purposes. AMAG’s provision of those documents shall be made in accordance with the time-schedule agreed upon between the Parties at the JDC.

(e)    Information Exchange and Development Assistance. The JDC shall discuss and determine what other information and data is necessary or reasonably useful for each

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Party to perform its obligations and exploit its rights under this Agreement. The Parties acknowledge that such information may include certain Know-How that is generated during the Term [***]. Any data provided by one Party to the other Party under this Section 3.1(e) shall be provided in the original language in which such data was generated, provided that, if such original language is not English, then the Party supplying such data shall, upon the receiving Party’s request, also provide English translations thereof [***]. The Parties will cooperate and reasonably agree upon formats and procedures to facilitate the orderly and efficient exchange of such Know-How.

(f)    Investigator Sponsored Clinical Studies. If, prior to Regulatory Approval of the Product in the United States, Norgine wishes to support any ISR, it shall notify AMAG thereof along with the relevant details of such ISR, and request AMAG’s approval of such ISR, [***]. AMAG shall provide to Norgine written notice of AMAG’s consent or rejection of such ISR within [***] after Norgine’s notification thereof. If AMAG fails to provide such notice within such [***] period, AMAG’s consent shall be deemed given. In connection with AMAG’s evaluation of such ISR, Norgine shall provide any additional information regarding such ISR that is reasonably requested by AMAG. [***]. After Regulatory Approval of the Product in the United States, each Party shall inform the other Party through the JSC of any proposed ISRs that such Party intends to approve (which, in all cases, shall be prior to such Party becoming contractually bound to carry out such ISR), and shall consider the other Party’s comments and concerns in good faith.

3.2    Development Costs.

(a)    Norgine Cost Share. Norgine shall reimburse AMAG for [***] of the Development Costs incurred by AMAG in conducting the Phase 3 Program activities set forth in the Development Plan (the “Norgine Cost Share”), provided that (i) the Development Costs are in accordance with the Phase 3 Budget, and (ii) the Pivotal Clinical Trial is conducted in at least the following [***] countries: [***]. AMAG shall invoice Norgine for the Norgine Cost Share on a quarterly basis and Norgine shall pay all undisputed invoices within [***] following receipt of same.

(b)    Initial Phase 3 Budget. The Parties shall agree on an initial Phase 3 Budget within [***], and shall update the Development Plan to include such initial Phase 3 Budget.

(c)    Expert Advice for Failure to Agree. If the Parties fail to agree on an initial Phase 3 Budget within [***], and after attempting to resolve such Dispute under Section 2.3, then, if elected by either Party, the initial Phase 3 Budget will be determined through [***]:

(i)    [***]

(ii)    [***]

(iii)    [***]

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(iv)    Responsibility for Costs. [***].

(d)    Review and Adjustment of the Phase 3 Budget. The JDC shall review and may adjust the Phase 3 Budget [***] for the next Calendar Year or in connection with updates to the Development Plan. In the event the Parties disagree on a proposed adjustment to the Phase 3 Budget:

(i)    [***].

(ii)    [***].

(iii)    [***].

(iv)    [***].

3.3    Regulatory Responsibilities.

(a)    Subject to the completion by AMAG of the Pivotal Clinical Trial as set forth in the Development Plan, Norgine shall use Commercially Reasonable Efforts to seek and maintain Regulatory Approval (and required pricing and reimbursement approvals) for the Product in the Norgine Territory, and to achieve each Regulatory Milestone Event. Without limiting the foregoing, subject to the terms and conditions of this Agreement, Norgine shall be responsible for, [***], (i) the filing and obtaining of all Regulatory Submissions, (ii) responding to inquiries and correspondence from the Regulatory Authorities and (iii) the submission of all required reports throughout clinical Development (after completion of the Pivotal Clinical Trial) and Commercialization, in each case ((i) through (iii)) in or for the Norgine Territory, in compliance with all Applicable Laws and Regulations. Norgine or its designee shall hold and own all such Regulatory Submissions. At the reasonable request [***], AMAG will reasonably assist Norgine in connection with Norgine’s activities under this Section 3.3(a) with respect to the Product in the Field in the Norgine Territory, including providing necessary documents or other materials required by Applicable Laws and Regulations.

(b)    Norgine shall notify AMAG of any material written or electronic communication received by Norgine from a Regulatory Authority regarding the Product within [***] of receipt of such communication and upon AMAG’s request, provide a copy of such communication within [***] of such request unless otherwise specified by AMAG. AMAG shall be responsible for providing to Norgine any revisions to the investigator’s brochure and CMC information required for Regulatory Submissions. If permitted by the Regulatory Authorities, AMAG (or its designee) shall have a right to participate (and Norgine may otherwise request AMAG to participate) in meetings with the Regulatory Authorities in the Major European Countries and any rapporteur country regarding the Product.

(c)    As between the Parties, AMAG shall be responsible for (i) the filing and obtaining all Regulatory Submissions, (ii) responding to inquiries and correspondence from the Regulatory Authorities responsible for regulatory matters, and (iii) the submission of all required reports throughout clinical Development and Commercialization, in each case ((i) through (iii))

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in the AMAG Territory, in compliance with all Applicable Laws and Regulations. AMAG shall notify Norgine of any material written or electronic communication received by AMAG from a Regulatory Authority regarding the Product within [***] of receipt of such communication and upon Norgine’s request, provide a copy of such communication within [***] of such request unless otherwise specified by Norgine. If permitted by the Regulatory Authorities, Norgine (or its designee) shall have a right to attend (and AMAG may otherwise request Norgine to participate in) meetings with the FDA regarding the Product.

(d)    Each Party shall provide information to the other Party as necessary and reasonably consult with the other Party regarding any filings, and regarding significant or material notices, actions or requests from or by Regulatory Authorities in such Party’s territory. Each Party shall, at the other Party’s request, review and comment on filings, submissions, and responses to Regulatory Authorities related to the Product.

3.4    Records of Correspondence with Regulatory Authorities. Following each material communication (whether by phone or in person) with a Regulatory Authority regarding matters arising under this Agreement, each Party shall prepare a record of such meeting in accordance with its standard business practices (e.g., written minutes) and provide to the other Party a summary of such record in English within [***].

3.5    Right of Reference.  Each Party shall have and is hereby granted the right to cross-reference the Regulatory Submissions and Regulatory Approvals (and each Party’s Related Parties’ Regulatory Submissions and Regulatory Approvals) related to the Product, and to access such Regulatory Submissions and Regulatory Approvals and any data therein to the extent necessary or reasonably useful to perform its obligations and exercise of its rights under this Agreement, including inclusion of such data in its own Regulatory Submissions for the Product free of charge. For clarity, AMAG may use such data in connection with its activities in the AMAG Territory and Norgine may use such data in connection with its activities in the Norgine Territory. Each Party hereby grants, and will cause its Related Party to grant, to the other Party and the other Party’s Related Party a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) in the United States, or an equivalent right of access/reference in any other country or region, to any data, including such Party’s or its Related Party’s clinical dossiers, Controlled by such Party or such Related Party that relates to the Product for use by the other Party to Develop and Commercialize the Product in the Field pursuant to this Agreement. For clarity, AMAG may use such Right of Reference to Develop and Commercialize the Product in the AMAG Territory and Norgine may use such Right of Reference to Develop and Commercialize the Product in the Norgine Territory. Each Party shall provide a signed statement to this effect, if requested by the other Party, in accordance with 21 C.F.R. § 314.50(g)(3) or the equivalent as required in any country or region or otherwise provide appropriate notification of such right of the other Party to the applicable Regulatory Authority and shall cause its Related Party to provide such signed statement. Each Party will provide, and will use reasonable efforts to cause its Related Party to provide cooperation to the other Party to effect the foregoing.

3.6    Global Safety Database. AMAG shall establish and maintain in compliance with Applicable Laws and Regulations the global safety database for the Product [***]. AMAG will

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provide necessary safety information for the Product from the global safety database in response to any reasonable request by Norgine in accordance with the terms of a pharmacovigilance agreement to be negotiated by the Parties in good faith following the Effective Date. During the Term and thereafter as required in order to comply with Applicable Laws and Regulations, each Party and its Related Parties will provide the other Party with all information necessary or desirable for such other Party to comply with its pharmacovigilance responsibilities, including any adverse drug experiences, in each case in the form reasonably requested by such other Party and as set forth in more detail in the pharmacovigilance agreement.

3.7    Information and Cooperation. Without limiting the other provisions of this Agreement, each Party shall use Commercially Reasonable Efforts to reasonably cooperate with the other Party in relation to the work under this Agreement and keep the other Party informed of its Development with respect to the Product, and shall provide to the other Party, as appropriate, regular summary updates through the JDC.

4.    Commercialization

4.1    In General

(a)    Norgine Responsibilities. Norgine shall use Commercially Reasonable Efforts to Commercialize the Product throughout the Norgine Territory. Subject to the foregoing and to the terms and conditions of this Agreement, Norgine shall have full responsibility and authority for all aspects of the Commercialization of the Product in the Norgine Territory [***], including developing and executing a plan for commercial launch, obtaining all required approvals from Regulatory Authorities for Commercialization (including seeking and obtaining pricing and reimbursement approvals where required for Commercialization), marketing and promotion, booking sales and distribution and performance of related services, providing customer support, including handling medical queries, and performing other related functions.Norgine shall update AMAG regarding its Commercialization activities at regular meetings of the JSC. Norgine shall provide written notification to AMAG as to the occurrence of the First Commercial Sale in the Norgine Territory within [***] after such occurrence.

(b)    AMAG Responsibilities. AMAG shall have full responsibility and authority for all aspects of the Commercialization of the Product in the AMAG Territory [***], including obtaining all required approvals from Regulatory Authorities for such Commercialization, marketing and promotion, booking sales and distribution and performance of related services, providing customer support, including handling medical queries, and performing other related functions. AMAG shall update Norgine regarding its Commercialization activities at regular meetings of the JSC.

4.2    Sales and Distribution.

(a)    Orders and Sales. Norgine shall be solely responsible for handling all returns, order processing, invoicing and collection, distribution, and inventory and receivables for the Product throughout the Norgine Territory. Norgine shall have the right and sole responsibility for establishing and modifying the terms and conditions with respect to the sale of

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the Product in the Norgine Territory, including any terms and conditions relating to or affecting the price at which the Product shall be sold, discounts available to any Third Party payers (including managed care providers, indemnity plans, unions, self-insured entities, and government payer, insurance or contracting programs), any discount attributable to payments on receivables, distribution of the Product, and credits, price adjustments, or other discounts and allowances to be granted or refused; provided, however, that Norgine shall act in good faith when doing the foregoing.

4.3    Pricing. Norgine shall determine all pricing of the Product in the Norgine Territory, with the understanding that Norgine shall also be solely responsible for preparing and implementing the reimbursement strategy for the Product in the Norgine Territory. AMAG shall, subject to any restrictions imposed under Applicable Laws and Regulations, use reasonable efforts to provide all the data reasonably deemed necessary by Norgine and within its possession or control so as to support any application by Norgine for desired medical reimbursement rates in the Norgine Territory.

4.4    Product Branding; Promotional Materials; Product Training.

(a)    Norgine shall reasonably cooperate with AMAG and its designees to establish a global branding strategy for the Product worldwide. Norgine shall Commercialize the Product in the Norgine Territory under the worldwide brand and consistent with such global branding strategy, subject to variations reasonably determined by Norgine (and discussed with AMAG) to be appropriate based on the needs of particular countries in the Norgine Territory. To the extent such branding is not permitted by any applicable Regulatory Authority in the Norgine Territory, the Parties, through the JSC, shall discuss in good faith an alternative brand or adjustment to the global branding strategy. [***].

(b)    AMAG shall develop and implement training programs regarding the Product and the Commercialization thereof [***] for use in the AMAG Territory. [***]. Norgine shall ensure that each member of its Commercialization staff satisfactorily completes the level of training appropriate for such Person’s position and expected Commercialization activities under this Agreement in accordance with Applicable Laws and Regulations. For clarity, nothing in this Section 4.4(b) shall preclude Norgine from developing its own training program for the Product for its and its Sublicensees’ personnel; provided that, upon AMAG’s reasonable request, Norgine will provide AMAG with a reciprocal right to access such materials and to review and comment on any such materials, and Norgine shall not unreasonably refuse to implement any AMAG comments.

4.5    Diversion.

(a)    Norgine hereby covenants and agrees that it shall not, either directly or indirectly, promote, market, distribute, import, sell or have sold the Product, including via the Internet or mail order, to any Third Party, address or Internet Protocol address outside of the Norgine Territory, provided that the foregoing shall not restrict Norgine from (i) participating in international meetings and conferences, medical congresses and the like outside of the Norgine Territory, and marketing and promotion of the Product to Third Party attendees at such meetings,

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conferences, and congresses for the Norgine Territory, and (ii) engaging key opinion leaders from outside the Norgine Territory to participate in education, advisory, and other activities relating to the Product in the Norgine Territory.

(b)    If any material quantity of Product sold by Norgine or any of its Affiliates or any of their Sublicensees, wholesalers or Distributors is diverted for promotion, marketing, distribution, importation or sale outside the Norgine Territory, the following shall apply: (i) if the Product was diverted by an identifiable wholesaler, Distributor, employee or agent of Norgine then, [***]; and (ii) if [***], then Norgine, to the extent permitted by Applicable Laws and Regulations, [***]. For purposes of this Section 4.5(b), a “material quantity of Product” shall be [***] of Net Sales of the Product in the AMAG Territory.

(c)    AMAG hereby covenants and agrees that it shall not, either directly or indirectly, promote, market, distribute, import, sell or have sold the Product, including via the Internet or mail order, to any Third Party, address or Internet Protocol address inside of the Norgine Territory, provided that the foregoing shall not restrict AMAG from (i) participating in international meetings and conferences, medical congresses and the like in the Norgine Territory, and marketing and promotion of the Product to Third Party attendees at such meetings, conferences, and congresses for the AMAG Territory, and (ii) engaging key opinion leaders from the Norgine Territory to participate in education, advisory, and other activities relating to the Product in the AMAG Territory.

(d)    If any material quantity of Product sold by AMAG or any of its Affiliates or any of their Licensees, wholesalers or Distributors is diverted for promotion, marketing, distribution, importation or sale outside the AMAG Territory, the following shall apply: (i) if the Product was diverted by an identifiable wholesaler, Distributor, employee or agent of AMAG then, [***]; and (ii) if any [***], then AMAG, to the extent permitted by Applicable Laws and Regulations, [***]. For purposes of this Section 4.5(d), a “material quantity of Product” shall be [***] of Net Sales of the Product in the Norgine Territory.

4.6    Competitive Products.

(a)    During [***], neither Norgine nor any of its Affiliates shall, directly or indirectly or with or through any Third Party, Develop, Manufacture, or Commercialize a Competitive Product anywhere in the world.

(b)    During [***], neither AMAG nor any of its Affiliates shall, directly or indirectly or with or through any Third Party, Develop, Manufacture, or Commercialize a Competitive Product anywhere in the Norgine Territory.

(c)    Notwithstanding Sections 4.6(a) and 4.6(b), if (i) a Business Combination occurs with respect to either Party with a Third Party that has a material pharmaceutical program other than programs directed to a Competitive Product or (ii) a Party acquires a Third Party that has a material pharmaceutical program other than programs directed to a Competitive Product (including by a merger or consolidation) so that such Third Party becomes an Affiliate over which the acquiring Party has control (as defined in Section 1.2), or (iii) a Party acquires all or

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substantially all of the assets of a Third Party (including any subsidiaries or divisions thereof) that has a material pharmaceutical program other than programs directed to a Competitive Product (each of (i), (ii) and (iii), a “Business Acquisition”; such Party, the “Business Party”), and, in each case, the Third Party (or any of such Third Party’s then-existing Affiliates) already has, or the acquired assets contain, as applicable, a program that existed prior to, or was planned prior to and is demonstrably to be implemented shortly after, the Business Acquisition that would otherwise violate Section 4.6(a) or Section 4.6(b) at the time of such Business Acquisition (a “Business Program”), then such Third Party (or such Third Party’s Affiliate) or the Business Party, as applicable, shall be permitted to continue such Business Program after such Business Acquisition and such continuation shall not constitute a violation of Section 4.6(a) or Section 4.6(b) above; providedhoweverthat (A) none of the AMAG Licensed Technology, Norgine Licensed Patents, Norgine Licensed Know-How, or other Patents or Know-How Controlled by the other Party and, in each case, licensed to the Business Party shall be used in the Business Program, and (B) the research or Development activities required under this Agreement shall be conducted separately from any research or Development activities directed to such Business Program, including the maintenance of separate lab notebooks and records (password-protected to the extent kept on a computer network) and separate personnel working on each of the activities under this Agreement and the activities covered under such Business Program. The Business Party shall adopt reasonable procedures to limit the dissemination of Confidential Information to only those personnel having a need to know such Confidential Information in order for such Business Party and/or the Third Party, as applicable, to perform its obligations or to exercise its rights under this Agreement, including, in furtherance of the foregoing goal, adoption of reasonable procedures to prohibit and limit the use and disclosure of Confidential Information for competitive reasons against the other Party and its Affiliates, including the use of Confidential Information for the research, Development, Manufacture or Commercialization of Products, and to prohibit or limit Confidential Information from being disclosed to or used by any person who is also working on or making scientific, intellectual property or commercial decisions regarding Products at the time of receipt or use of any Confidential Information, or within [***] following receipt or use of any Confidential Information.

4.7    Recalls, Market Withdrawals or Corrective Actions. In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with the Product, or in the event either Party determines that an event, incident or circumstance has occurred that may reasonably be expected to result in the need for a recall or market withdrawal of the Product in its own territory, the Party notified of such recall or similar action, or the Party that desires such recall or similar action, shall, within [***] of such request, order or determination, notify the other Party by telephone, facsimile or e-mail. Each Party, in consultation with the other Party [***], shall decide whether to conduct a recall of the Product in its own territory [***], provided that, each Party shall provide the other Party with at least [***] notice of any decision to effectuate a recall (except in the case of a government mandated recall, when such Party may act (i) without such advance notice but shall notify the other Party [***]. Each Party will make available all of its pertinent records that may be reasonably requested by the other Party in order to effect a recall of the Product in the other Party’s Territory. The Parties’ rights and obligations under this Section 4.7 shall be subject to the terms of any Supply Agreement(s) or Ancillary Agreements entered into between the Parties.

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4.8    Compliance.

(a)    Each Party shall, and shall use reasonable efforts to cause its respective Affiliates, officer(s), director(s), employee(s), agent(s), representative(s), consultant(s), contractor(s), Distributor(s) and Sublicensee(s) (the “Party Representatives”)to, comply with the terms of this Agreement and all Applicable Laws and Regulations (including the U.S. Foreign Corrupt Practices Act of 1977, as amended (“FCPA”) and other Anti-Corruption Laws) relating to activities performed or to be performed by such Party Representatives under or in relation to the Development, pursuit of Regulatory Approval, and Commercialization of the Product pursuant to this Agreement.

(b)    Each Party represents and warrants to the other Party that, as of the Effective Date, it and its Affiliates are in compliance with the Anti-Corruption Laws of those countries where it operates (including the FCPA to the extent applicable). Each Party covenants that each Party Representative engaged by such Party or its Affiliate to perform activities under this Agreement will, to such Party’s knowledge, be in compliance with the Anti-Corruption Laws of those countries where such Party Representative operates (including the FCPA to the extent applicable) at the time such Party Representative is engaged to perform such activities.

(c)    In connection with this Agreement, each Party agrees that it and its Party Representatives will not make, offer, give, promise to give, or authorize, any bribe, kickback, payment or transfer of anything of value, directly or indirectly, to any (A) executive, official, employee or agent of a governmental department, agency or instrumentality, (B) director, officer, employee or agent of a wholly or partially government-owned or -controlled company or business, (C) political party or official thereof, or candidate for political office, or (D) an executive, official, employee or agent of a public international organization (“Government Official”) for the purpose of: (i) improperly influencing any act or decision of the person or Government Official; (ii) inducing the person or Government Official to do or omit to do an act in violation of a lawful or otherwise required duty; (iii) securing any improper advantage; or (iv) inducing the person or Government Official to improperly influence the act or decision of any organization, including any government or government instrumentality, in order to assist such Party in obtaining or retaining business relating to the Product under this Agreement.

(d)    Each Party agrees that should it learn or have reason to know of any payment or transfer (or any offer or promise to pay or transfer) relating to this Agreement that violate the FCPA or any applicable Anti-Corruption Law and would reasonably be likely to result in an enforcement proceeding under the FCPA or any applicable Anti-Corruption Law, it shall promptly disclose it to the other Party. The Parties will cooperate in any investigation related to any such payment or transfer.

(e)    (i)    Each Party shall have the right to terminate this Agreement, without penalty, on [***] prior written notice by such Party, if the other Party or any of its Party Representatives is (a) convicted in a court of law of violating an applicable Anti-Corruption Law; or (b) enters into a settlement with a government authority with an admission of liability under an applicable Anti-Corruption Law.

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(ii)    Each Party shall have the right to terminate this Agreement, without penalty, on [***] prior written notice by such Party with respect to the relevant country (or countries) in the Norgine Territory or AMAG Territory, if a Party [***], that the other Party or any of its Party Representatives violated an applicable Anti-Corruption Law in such country (or countries) in connection with the performance of this Agreement.

(iii)    [***]

(iv)    [***]

(v)    This Section 4.8(e), and not Section 14.3, shall exclusively apply to violations of the FCPA or other Anti-Corruption Laws by a Party or any of its Party Representatives.

(f)    Each Party may disclose the terms of this Agreement or any action taken under this Section 4.8 to prevent a potential violation or continuing violation of applicable Anti-Corruption Laws, including the identity of the other Party and the payment terms, to any government authority if such Party determines, upon advice of counsel, that such disclosure is necessary.

5.    Manufacture and Supply

5.1    Responsibility for Supply. Subject to Sections 5.6 and 5.7, AMAG shall be responsible for the Manufacture, either by itself or through one or more Third Parties selected by AMAG at its sole discretion, [***], of all clinical (if applicable) and commercial supplies of the Product necessary for the Development and Commercialization of the Product in the Norgine Territory, in each case in accordance with this Section 5.1 and the Supply Agreements, except as the Parties may otherwise agree in writing. Not later than [***], AMAG shall enter into written agreement(s) with one or more Third Party contract manufacturers for the commercial supply of Product that are sufficient to fulfill AMAG’s obligation to supply [***] (pursuant to AMAG’s obligations under this Agreement), commercial supplies of Product to Norgine hereunder (a “CMO Agreement”). [***]. If AMAG fails to enter into a CMO Agreement by such date, then upon [***] prior written notice to AMAG, Norgine shall have the right to assume Manufacturing of the Product for the Norgine Territory pursuant to Section 5.6, provided that if AMAG enters into a CMO Agreement within such [***] notice period, Norgine shall not have the right to assume Manufacturing of the Product. [***]. The foregoing remedies set forth in this Section 5.1 shall be Norgine’s sole and exclusive remedy, and AMAG’s sole and exclusive obligation, with respect to any breach by AMAG of its obligation to enter into a CMO Agreement by the date specified in this Section 5.1. Any Product supplied to Norgine by AMAG shall be delivered to Norgine in unlabeled vials [***] for the country or countries in the Norgine Territory for which the Product is delivered [***].

5.2    Supply Agreement. Within [***], the Parties shall in good faith negotiate and enter into a supply agreement (the “Commercial Supply Agreement”) governing the commercial supply of the Product to Norgine for its requirements of the Product for Commercialization in the Norgine Territory, together with a related quality agreement and pharmacovigilance agreement

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(such agreements, “Ancillary Agreements”). In the event that Norgine is required to perform a Regulator-Requested Trial, the Parties [***] negotiate and enter into a supply agreement (“Clinical Supply Agreement” and, together with Commercial Supply Agreement, the “Supply Agreements”) governing the supply of the Product to Norgine needed to carry out any Regulator-Requested Trial required to be performed by Norgine pursuant to Section 3.1(b). The price of clinical and commercial quantities of Product ordered by Norgine under the Supply Agreements, shall be equal to [***] of AMAG’s Fully Burdened Manufacturing Costs for the Product. The Supply Agreements shall provide other customary terms and conditions, such as acceptance and rejection procedures, forecasts and order procedures, recall and release procedures, release documentation, change controls, and audit rights by Norgine, in each case to be consistent with the terms and conditions of the CMO Agreement(s) and taking into consideration any [***] under the CMO Agreement(s) as reasonably agreed by the Parties.

5.3    Expert Resolution for Failure to Agree. If the Parties fail to reach agreement and enter into a Supply Agreement within the applicable period set forth in Section 5.2, and after attempting to resolve such Dispute under Section 2.3, then, if elected by either Party, the final terms and conditions of such Supply Agreement will be determined [***]:

(a)    [***]

(b)    [***]

(c)    [***]

(d)    [***]

5.4    Change of Manufacturing Process. AMAG shall reasonably inform Norgine of developments in matters of process development and Manufacturing of the Product, and shall consult with Norgine with respect to the development and manufacturing processes of the Product adopted by AMAG to the extent necessary to obtain Regulatory Approval(s) of the same in the Norgine Territory. Norgine shall promptly notify AMAG of any information that may impact approvability of the Product in the Norgine Territory. [***].

5.5    Target FBMC. AMAG shall use Commercially Reasonable Efforts to achieve the target FBMC established by the JDC for the Product supplied for Commercialization in the Norgine Territory.

5.6    Manufacturing Transfer.

(a)    Without limiting Section 5.1, Norgine shall have the option of assuming the responsibility for the Manufacture of clinical and commercial supplies of the Product upon written notice to AMAG (i) in the event of a material breach of a Supply Agreement, subject to the materiality, notice and cure provisions agreed by the Parties pursuant to such Supply Agreement; (ii) under the circumstances set forth in Section 5.1; (iii) if the supply price for Product supplied to Norgine for Commercialization in the Norgine Territory exceeds at any time

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[***] in the Norgine Territory; or (iv) a Supply Disruption (each of (i) through (iv), a “Manufacturing Transition Event”).

(b)    Upon the occurrence of a Manufacturing Transition Event, if Norgine elects to Manufacture or have Manufactured the Product for the Norgine Territory, Norgine shall provide to the JDC its plans for Manufacturing, including any Third Parties Norgine intends to use to Manufacture the Product, and then within [***] of the JDC’s review of such plans, the Parties shall agree on a technology transfer plan, pursuant to which AMAG shall [***]. Norgine may make such transfer request for itself or for a Norgine-selected Third Party manufacturer, provided that Norgine shall not use any Third Party manufacturer that AMAG has contracted with or that AMAG has informed Norgine of its intent to contract with for the Manufacture of the Product (“Technology Transfer”). Such Technology Transfer shall be commenced within a commercially reasonable timeframe following Norgine’s request. To the extent AMAG uses a Third Party to Manufacture Product, AMAG shall use Commercially Reasonable Efforts to procure the cooperation of such Third Party in the Technology Transfer, provided that AMAG shall not be responsible for transferring technology from such Third Party manufacturer to Norgine beyond that which AMAG is able to procure through such Commercially Reasonable Efforts. Any such Third Party manufacturers designated by Norgine to receive a Technology Transfer shall be required to sign with AMAG a confidentiality agreement on terms reasonably acceptable to AMAG. [***].

(c)    The Parties contemplate that remedies for any Supply Disruption or failure by AMAG to perform under any Supply Agreement shall be addressed in the Supply Agreement(s) and any such Supply Disruption or failure shall not constitute a material breach of this Agreement. For purposes of clarity, (i) this Section 5.6(c) is without prejudice to the provisions of Sections 5.6(a) and 5.6(b) and (ii) the remedies set forth in Section 14.7 of this Agreement shall not apply to any such Supply Disruption or failure.

5.7    Major Safety Issue. If AMAG [***] determines [***] that there is a Major Safety Issue with respect to the Product, it shall notify Norgine that it intends to stop Developing and/or Commercializing the Product and as a result intends to stop supplying Norgine with clinical or commercial quantities of the Product (as applicable) pursuant to the then-applicable Supply Agreement. [***]. Following notification by AMAG of its determination of a Major Safety Issue, AMAG’s supply obligations under Sections 5.1 and 5.2 shall no longer apply.

6.    Payments

6.1    Upfront Payment. On the Effective Date, Norgine shall pay to AMAG Thirty Million Dollars ($30,000,000), which shall be non-refundable and non-creditable against any other payments due under this Agreement.

6.2    Regulatory Milestone Payments.

(a)    Norgine shall pay to AMAG the one-time milestone payments listed below for the first achievement of the corresponding milestone event (each such event, a

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“Regulatory Milestone Event” and each such payment, a “RegulatoryMilestone Payment”), which in each case shall be non-refundable and non-creditable.

Regulatory Milestone Event	Milestone Payment ($)
Grant of conditional Regulatory Approval of the Product by the EMA pursuant to Commission Regulation (EC) No 507/2006	[***]
Grant of Regulatory Approval of the Product by the EMA	[***]
Achievement of pricing and reimbursement approval for the Product in three (3) of the Major European Countries of at least [***] per vial	[***]
Achievement of pricing and reimbursement approval in all of the Major European Countries for an indication that includes [***], provided that this Regulatory Milestone Payment shall be payable only to the extent AMAG is required to pay the corresponding milestone payment under the [***].	[***]

(b)    Each of the Regulatory Milestone Payments described above shall be payable only once, regardless of the number of times the associated Regulatory Milestone Events are achieved. If the EMA grants Regulatory Approval of the Product without first granting conditional Regulatory Approval pursuant to Commission Regulation (EC) No 507/2006, then Norgine will pay the sum of [***] upon Regulatory Approval of the Product by the EMA. If the [***] is paid by Norgine and AMAG subsequently is entitled to any credit under the [***] with respect to the [***], AMAG shall promptly pay to Norgine the amount of such credit.

(c)    Norgine shall provide written notification to AMAG of the achievement of each of the Regulatory Milestone Events described above within [***] after each such achievement. AMAG shall deliver to Norgine a written invoice for the Regulatory Milestone Payment promptly after receipt of such written notification from Norgine. All Regulatory Milestone Payments shall be due and payable within [***] after receipt of such invoice from AMAG.

6.3    Sales Milestone Payments.

(a)    Norgine shall pay to AMAG the one-time milestone payments listed below (each, a “SalesMilestone Payment”) for the first achievement of the corresponding one-time milestone event (each, a “SalesMilestone Event”), which in each case shall be non-refundable and non-creditable.

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Sales Milestone Event	Milestone Payment ($)
(A) First occurrence of a Calendar Year in which aggregate Annual Net Sales of the Product in the Norgine Territory equal or exceed [***]	[***]
(B) First occurrence of a Calendar Year in which aggregate Annual Net Sales of the Product in the Norgine Territory equal or exceed [***]	[***]
(C) First occurrence of a Calendar Year in which aggregate Annual Net Sales of the Product in the Norgine Territory equal or exceed [***]	[***]
(D) First occurrence of a Calendar Year in which aggregate Annual Net Sales of the Product in the Norgine Territory equal or exceed [***]	[***]
(E) First occurrence of a Calendar Year in which aggregate Annual Net Sales of the Product in the Norgine Territory equal or exceed [***]	[***]
(F) First occurrence of a Calendar Year in which aggregate Annual Net Sales of the Product in the Norgine Territory equal or exceed [***]	[***]

(b)    Each of the Sales Milestone Payments described above shall be payable only once, regardless of the number of times the associated Sales Milestone Events are achieved.

(c)    Norgine shall provide written notification to AMAG of the achievement of each of the milestones described above within [***] after each such achievement. AMAG shall deliver to Norgine a written invoice for the Sales Milestone Payment promptly after receipt of such written notification from Norgine. All Sales Milestone Payments shall be due and payable within [***] after receipt of such invoice from AMAG.

6.4    Product Royalties.

(a)    Subject to Section 6.5, Norgine shall pay to AMAG a royalty at the rate determined in accordance with the royalty chart set forth below on Net Sales of the Product in the Norgine Territory for the Royalty Term.

Aggregate Net Sales threshold of the Product in the Norgine Territory:	Royalty Rate (%):
On that portion of aggregate Annual Net Sales less than [***]	[***]
On the portion of Annual Net Sales equal to or greater than [***] but less than [***]	[***]
On that portion of Annual Net Sales equal to or greater than [***]	[***]

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(b)    For purposes of determining when the Annual Net Sales thresholds as set forth above have been met, Calendar Quarter Net Sales shall be converted from local currency in the region or country in the Norgine Territory into Euros using the exchange rate set forth in Section 6.7 when calculating the amount of payment of royalties due, and the converted Calendar Quarter Net Sales amounts for the four Calendar Quarters in a Calendar Year will be used to determine whether the Annual Net Sales thresholds have been met.

6.5    Royalty Adjustments.

(a)    Antistacking. On a country-by-country basis, the royalties otherwise payable by Norgine to AMAG under Section 6.4 with respect to Net Sales of Product by Norgine, its Affiliates or Sublicensees for a Calendar Quarter may be reduced by [***] of the royalties actually paid by Norgine to any Third Party licensor pursuant to a Norgine In-License with respect to such country and Calendar Quarter.

(b)    Generic Competition. On a country-by-country [***] basis, the royalty rates otherwise due to AMAG shall be reduced if and for so long as Generic Competition exists in such country during [***] in the following amounts: [***]. For purposes of this Section 6.5(b), “Generic Product” means, in a given country, a product that (x) has the same active pharmaceutical ingredient(s) as the Product and that has received all necessary Regulatory Approval(s) from such Regulatory Authorities in such country to market and sell such product as a pharmaceutical product for any of the indications included in the approved labeling for the Product, where such Regulatory Approval(s) were obtained by making a reference to or relying on data provided to relevant Regulatory Authorities in the application(s) for Regulatory Approval for the Product, and (y) is sold in such country by a Third Party that has not obtained the rights to market or sell such product as a Sublicensee or Distributor of Norgine or any of its Affiliates or Sublicensees with respect to the Product. For purposes of this Section 6.5(b), “Generic Competition” means, with respect to the Product in a given country [***], one or more Generic Products is commercially available in such country and such Generic Product(s) [***].

(c)    Limitation. In no event shall the royalty reductions described in this Section 6.5, alone or together, reduce the royalties payable by Norgine for the Product in a country [***].

6.6    Quarterly Reports; Payment. During the Term, following the First Commercial Sale of the Product in the Norgine Territory, Norgine shall furnish to AMAG a quarterly written report for the Calendar Quarter showing the Net Sales of the Product subject to royalty payments sold by Norgine and its Related Parties in the Norgine Territory during the reporting period and the royalties payable under this Agreement. Reports under this Section 6.6 shall be due on the [***] following the close of each Calendar Quarter in a form reasonably agreed to by the Parties, summarizing the calculation of Net Sales for such Calendar Quarter, which shall include, without limitation (i) the gross amount invoiced for the Product sold, (ii) an itemized listing of the type and amount of all deductions and offsets taken from the gross amount invoiced to arrive at the Net Sales calculation, and (iii) to the extent applicable, the basis for any adjustments pursuant to Section 6.5 to the royalty payable hereunder on a country-by-country basis. AMAG promptly shall deliver to Norgine a written invoice for the royalties shown to have accrued by each report,

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and Norgine shall, unless otherwise specified under this Agreement, pay such invoice within [***] after receipt of such invoice from AMAG.

6.7    Payment Exchange Rate.

(a)    All payments to be made by Norgine to AMAG under this Agreement shall be made in Dollars by bank wire transfer in immediately available funds to a bank account in the United States designated in writing by AMAG. For any Net Sales made in a currency other than Euros, such currency will be converted to Euros using Norgine’s then-current standard exchange rate methodology consistent applied for the translation of foreign currency sales into Euros. The royalties payable under Section 6.4 shall be calculated in Euros and the royalty payment payable to AMAG shall be converted into Dollars using the arithmetic daily average of the relevant published currency exchange rate published at http://fxtop.com, across the calendar quarter for which the relevant royalty payment is due, or such other source as the Parties may agree in writing.

(b)    In the event that, by reason of Applicable Laws and Regulations in any country, it becomes impossible or illegal for Norgine (or any of its Affiliates or Sublicensees) to transfer, or have transferred on its behalf, payments owed AMAG hereunder, Norgine will promptly notify AMAG of the conditions preventing such transfer and such payments will be deposited in local currency in the relevant country to the credit of AMAG in a recognized banking institution in that country designated by AMAG or, if none is designated by AMAG within a period of [***], in a recognized banking institution selected by Norgine or any of its Affiliates or its Sublicensees, as the case may be, and identified in a written notice given to AMAG.

6.8    Taxes. All taxes applicable to the Development, Manufacture, Commercialization, use, import, distribution or sale of the Product in the Norgine Territory or assessable on any payments made by Norgine to AMAG under this Agreement shall be paid by Norgine, with the exception of income taxes owed by AMAG. If Norgine is required under Applicable Laws and Regulations to deduct or withhold any taxes on any payments from Norgine to AMAG pursuant to this Agreement, Norgine shall pay any such taxes, pay such amounts to the relevant governmental entity on behalf of AMAG. Norgine shall furnish to AMAG appropriate evidence of payment (including official receipts) of such taxes or other amount required by Applicable Laws and Regulations to be deducted from any payment due under this Agreement to AMAG. The Parties will cooperate with one another and use reasonable efforts to reduce or eliminate tax withholding or similar obligations in respect of royalties, milestone payments, and other payments made by Norgine to AMAG under this Agreement. AMAG will provide Norgine any tax forms that may be reasonably necessary in order for Norgine not to withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty. Each Party will provide the other with reasonable assistance to enable the recovery, as permitted by Applicable Laws and Regulations, of withholding taxes, value added taxes, or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party bearing such withholding tax.

7.    Record Keeping, Inspections and Audits

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7.1    Records.

(a)    Development, Manufacturing and Commercialization Activities. Each Party shall maintain appropriate records of: (i) all research, Development, Manufacturing and Commercialization events and activities conducted by it or on its behalf related to the Product hereunder, and all costs incurred in connection therewith, as applicable; and (ii) all significant information generated by it or on its behalf in connection with Development of the Product under this Agreement, in each case in accordance with such Party’s usual documentation and record retention practices and in compliance with Applicable Laws and Regulations in its territory, provided that this Section 7.1(a) shall not apply to sales and financial records addressed by Section 7.1(b). All records referenced by this Section 7.1(a) shall be in sufficient detail to properly reflect, in good scientific manner, all significant work done and results of studies and clinical trials undertaken, and further shall be at a level of detail appropriate for patent and regulatory purposes. Each Party and its Affiliates shall document, and shall cause its Licensees and Sublicensees (as applicable) to document, all clinical trials and other studies and research conducted pursuant to the terms of this Agreement in formal written study reports in accordance with applicable guidelines (e.g., cGCP, cGLP, and cGMP) and all other Applicable Laws and Regulations. Upon the reasonable request of a Party, the other Party shall make a summary of the information included in such records available to the requesting Party in a format to be mutually agreed by the Parties. Subject to Applicable Laws and Regulations (including, but not limited to, the data privacy act in each country), each Party shall also have the right to review original versions of such records maintained by the other Party and its Affiliates (and its non-Affiliate Related Parties) no more often than [***], at reasonable times, upon written request to other Party. Each Party shall cause its Related Parties to comply with this Section 7.1(a).

(b)    Records for Norgine Payments. Norgine shall keep complete and accurate records in sufficient detail to ensure that the Parties can accurately calculate the full amount of Sales Milestone Payments and royalties payable to AMAG under Sections 6.3 and 6.4.

(c)    AMAG FBMC and Other Costs. AMAG shall keep complete and accurate records with such detail as shall reasonably allow Norgine to determine the basis for such FBMC and the costs and expenses incurred by AMAG pursuant to the Phase 3 Budget including in the conduct of the Pivotal Clinical Trial. At the reasonable request of Norgine, AMAG shall make such records available to Norgine.

7.2    Audit Rights.

(a)    Upon the written request of a Party (“Requesting Party”) with reasonable advance notice and not more than [***], the other Party shall permit an independent certified public accounting firm of internationally recognized standing not utilized by the Requesting Party in the [***] period preceding such request and selected by the Requesting Party and reasonably acceptable to the other Party, at its own expense, to have access during normal business hours to such of the records as may be reasonably necessary to verify the that the correct amounts have been paid to or by such Party under this Agreement during any Calendar Year ending not more than [***] prior to the date of such request. The accounting firm shall disclose to the Requesting Party only whether the reports are correct or incorrect and the specific

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details concerning any discrepancies. No other information shall be provided to the Requesting Party in connection with this audit right. The audit report will be final and binding on the Parties, provided that each Party will be given an opportunity by the accounting firm to raise any manifest error in the audit report prior to the finalization of the audit report. The records for a particular Calendar Year may be audited only [***]. This right to audit shall remain in effect throughout the life of this Agreement and for a period of [***] after the termination of this Agreement.

(b)    Discrepancies. If such accounting firm identifies a discrepancy, the other Party shall pay the Requesting Party the amount of the discrepancy (whether underpayment or overpayment) within [***] of the date the Requesting Party delivers to the other Party such accounting firm’s written report so concluding, or as otherwise agreed upon by the Parties. [***].

(c)    Confidentiality. Each Party shall treat all information of the other Party subject to review under this Article 7 in accordance with the confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party and any applicable Related Parties, obligating it or them to retain all such information in confidence pursuant to such confidentiality agreement.

8.    Licenses

8.1    Licenses to Norgine.

(a)    Development and Commercialization License. Subject to the terms and conditions of this Agreement, AMAG hereby grants to Norgine an exclusive (including as to AMAG and its Affiliates), royalty-bearing license (or sublicense, as applicable), with the right to grant sublicenses (subject to Section 8.1(f)), under the AMAG Licensed Technology and the AMAG Licensed Trademarks to conduct the Development activities allocated to Norgine hereunder, and to Commercialize and otherwise distribute, sell, offer for sale and import the Product in the Field in the Norgine Territory during the Term. For purposes of clarity, AMAG may conduct Development activities in the Norgine Territory to the extent provided in the Development Plan.

(b)    Manufacturing License. Subject to the terms and conditions of this Agreement, AMAG hereby grants to Norgine, exercisable by Norgine from and after a Manufacturing Transition Event and for the remainder of the Term, a non-exclusive, royalty-free license (or sublicense, as applicable), with the right to grant sublicenses (subject to Section 8.1(f)), under the AMAG Licensed Technology and the AMAG Licensed Trademarks to Manufacture the Product in the Field anywhere in the world for the Norgine Territory. For purposes of clarity, any Net Sales of the Product manufactured by or on behalf of Norgine shall continue to be royalty-bearing in accordance with Article 6.

(c)    Post Royalty-Term License. The licenses granted to Norgine in Section 8.1(a) and 8.1(b) shall automatically convert, on a country-by-country basis in the Norgine Territory, to a fully paid-up, non-royalty bearing, perpetual, exclusive, irrevocable license upon the expiration of the Royalty Term applicable to such country (but not upon an earlier

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termination of this Agreement), provided that such license shall become non-exclusive in such country upon the commercial launch of a Generic Product in such country.

(d)    AMAG Third Party Agreements.

(i)    All licenses granted to Norgine in Section 8.1(a) and 8.1(b) are subject to the rights and obligations of AMAG under the AMAG Third Party Agreements. AMAG shall be responsible for all financial and payment obligations under each AMAG Third Party Agreement. Subject to Section 8.1(d)(ii), Norgine will comply with all applicable provisions of the AMAG Third Party Agreements in all material respects and Norgine agrees to (and shall cause its Related Parties to) timely perform and take such actions as may be required to allow AMAG to comply with its obligations thereunder, including to provide to AMAG such information and reports as it reasonably requires, comply with reasonable requests for access to Norgine’s (and its Related Parties’) records or facilities or otherwise cooperate with AMAG including with respect to any financial and regulatory reporting, audit and payment obligations under each AMAG Third Party Agreement, insofar as they relate to the Product or Norgine’s (and its Related Parties’) activities hereunder.

(ii)    AMAG shall disclose to Norgine the terms of each AMAG Third Party Agreement entered into after the Effective Date with which Norgine would be required to comply with under Section 8.1(d)(i), and otherwise provide Norgine with such assistance and information as Norgine reasonably requires to assess such provisions. If Norgine does not agree to the inclusion of such AMAG Third Party Agreement under this Agreement, then (A) the Patents and Know-How in-licensed under such AMAG Third Party Agreement shall not be deemed “Controlled” by AMAG (or included within the AMAG Licensed Technology) and (B) such agreement shall not be considered an AMAG Third Party Agreement.

(iii)    AMAG agrees that it shall reserve the right in such AMAG Third Party Agreement to disclose the terms of such agreement to Norgine (subject to confidentiality obligations), and grant sublicenses to Norgine as contemplated herein and use Commercially Reasonable Efforts to provide for the survival of any sublicenses granted thereunder in the event of termination of such agreement.

(e)    Clinical Data License. Subject to the terms and conditions of this Agreement, AMAG hereby grants to Norgine a royalty-free license, with the right to grant sublicenses (subject to Section 8.1(f)), during the Term to use all Clinical Data and other data Controlled by AMAG as necessary or useful for Norgine to (i) seek and maintain Regulatory Approval for the Product in the Norgine Territory, or (ii) to Commercialize the Product in the Field in the Norgine Territory or, (iii) from and after a Manufacturing Transition Event, to Manufacture, the Product in the Field for the Norgine Territory in each case ((i)-(iii)) during the Term. The license rights granted in clauses (i) and (ii) above are exclusive (including as to AMAG and its Affiliates) and in clause (iii) are non-exclusive. At Norgine’s request, AMAG shall provide a copy of the foregoing Clinical Data on a commercially reasonable schedule to Norgine. AMAG shall ensure that all Clinical Data generated by AMAG’s Affiliates and Licenseeswith respect to the Product are Controlled by AMAG.

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(f)    Sublicensees. In no event shall Norgine grant any sublicense to any of the rights granted to it pursuant to Section 8.1(a), 8.1(b) or 8.1(e) without AMAG’s prior written consent, such consent not to be unreasonably withheld, delayed or conditioned, except that such consent shall not be required with respect to sublicenses to (i) Affiliates of Norgine, (ii) Distributors of Norgine or its Affiliates, or (iii) consultants, subcontractors, or other suppliers or vendors (including contract research organizations and contract manufacturing organizations) who are engaged by Norgine to provide services directly related to the Development and Commercialization of the Product in the Norgine Territory. Each sublicense granted by Norgine shall be in writing and consistent with this Agreement and subordinate thereto, and Norgine shall remain responsible to AMAG for the compliance of each Sublicensee with the terms and conditions of this Agreement, including with respect to the financial and other obligations due under this Agreement. Norgine shall provide a copy of each such sublicense for which AMAG’s prior written consent is required (and all amendments or restatements thereof), which may be reasonably redacted as necessary to protect commercially sensitive information, to AMAG so that AMAG can confirm Norgine’s compliance with the foregoing. Each sublicense granted by Norgine under this Agreement shall permit the conversion of such sublicense to a direct license with AMAG at AMAG’s sole option (and discretion) in the event this Agreement is terminated and, upon such conversion, AMAG shall be responsible for all former obligations of Norgine under such sublicense. Norgine shall include in each such sublicense a requirement obligating such Sublicensee to reasonably cooperate with AMAG.

(g)    Limitations. During the Term, Norgine shall not (either by itself, or with or through a Related Party or Third Party) (i) Develop or Commercialize the Product, (ii) utilize any Clinical Data or (iii) practice the AMAG Licensed Technology, in each case of ((i), (ii) and (iii)) outside of the scope of this Agreement.

(h)    Rights Retained by AMAG. Norgine shall receive only those rights expressly granted by AMAG under the provisions of this Agreement, and any right not expressly granted to Norgine under the provisions of this Agreement shall be retained by AMAG.

8.2    Licenses to AMAG.

(a)    Product License. Subject to the terms and conditions of this Agreement, Norgine hereby grants to AMAG a royalty-free (except as provided in Section 14.6(b)(i)), perpetual, irrevocable license, with the right to grant sublicenses (through multiple tiers), under the Norgine Licensed Patents and Norgine Licensed Know-How that is incorporated into the Product or that is specifically related to the Product to the extent reasonably useful or necessary for AMAG (its Affiliates or Licensees) to (i) research, develop, make, have made and use the Product, or products containing or incorporating Ciraparantag (whether as a monotherapy, multi-therapy, combination or otherwise, but only with respect to Ciraparantag and not other therapeutically active ingredients) in the AMAG Territory and Norgine Territory, and (ii) sell, offer for sale and import the Product and such products in the AMAG Territory. The license granted in clause (i) above shall be co-exclusive with Norgine, and the license granted in clause (ii) above shall be exclusive. For clarity, the license granted to AMAG under this Section 8.2(a) shall survive expiration or termination of this Agreement. Each sublicense granted by AMAG

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shall be in writing and consistent with this Agreement and subordinate thereto, and AMAG shall remain responsible to Norgine for the compliance of each Sublicensee with the terms and conditions of this Agreement.

(b)    Clinical Data License. Subject to the terms and conditions of this Agreement, Norgine hereby grants to AMAG an exclusive, royalty-free, license, with the right to grant sublicenses, to use all Clinical Data and other data Controlled by Norgine as necessary or useful for AMAG to exercise its rights and fulfill its obligations under this Agreement with respect to the Development and Commercialization of the Product in the Field in the AMAG Territory. At AMAG’s request, Norgine shall provide a copy of the foregoing Clinical Data on a commercially reasonable schedule to AMAG. For clarity, the license granted to AMAG under this Section 8.2(b) shall survive expiration or termination of this Agreement. Norgine shall ensure that all Clinical Data generated by Norgine’s Affiliates and or its Related Partieswith respect to the Product are Controlled by Norgine.

8.3    Future In-License Agreements. If Norgine determines that any Patent Controlled by a Third Party is necessary for the Development, Commercialization, or, from and after a Manufacturing Transition Event, Manufacture of the Product in or for the Norgine Territory (each, a “Third Party Patent Right”), it shall provide written notice of such determination to AMAG. If AMAG agrees, in its reasonable discretion, that such Third Party Patent Rights are necessary or desirable for the Development or Commercialization or, from and after a Manufacturing Transition Event, Manufacture of the Product for the Norgine Territory, then AMAG shall have the first right to enter into such a license and shall sublicense such rights to Norgine under this Agreement. If AMAG determines to enter into such a license, then prior to doing so AMAG shall provide Norgine with a reasonable opportunity to review and comment on the proposed terms of such license that are applicable to Norgine as a fully paid-up, royalty-free sublicensee thereunder. AMAG shall use reasonable efforts to negotiate the terms of such license accordingly, and in any event subject to Section 8.1(d)(iii). If AMAG or any of its Affiliates does not enter a Third Party agreement for such Third Party Patent Rights within [***] after receipt of notice from Norgine or, if AMAG is using Commercially Reasonable Efforts to negotiate such Third Party agreement, [***] after receipt of notice from Norgine, or if AMAG provides written notice to Norgine that it does not intend to enter a license agreement for such Third Party Patent Rights, then Norgine may enter an agreement to obtain such a license (such agreement entered into by Norgine, a “Norgine In-License”). If the Norgine In-License provides for an exclusive, sublicensable license under such Third Party Patent Rights in the AMAG Territory, then Norgine shall inform AMAG and shall provide AMAG with a copy of such license. If AMAG notifies Norgine in writing that it wishes to obtain a non-exclusive sublicense of such rights in the AMAG Territory, Norgine shall grant such a sublicense to AMAG, and AMAG will be bound by the rights and obligations of such Norgine In-License as they apply to AMAG as a sublicensee, including all payment obligations that would be due under such agreement as a result of the sublicense thereof granted to AMAG and AMAG’s exercise of such sublicensed rights, including an equitable apportionment of any upfront fee or license fee as agreed to by the Parties.

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8.4    Limitations. During the Term, AMAG shall not (either by itself, or with or through an Affiliate, Licensee or Third Party) practice the Norgine Licensed Patents, Norgine Licensed Know-How or the Clinical Data or other data Controlled by Norgine outside of the scope of the licenses granted to AMAG under this Agreement.

8.5    Rights Retained by Norgine. AMAG shall receive only those rights expressly granted by Norgine under the provisions of this Agreement, and any right not expressly granted to AMAG under the provisions of this Agreement shall be retained by Norgine.

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

8.7    Section 365(n) of the Bankruptcy Code. All rights and licenses granted to either Party pursuant to any section of this Agreement are rights and licenses to “intellectual property” (as defined in Section 101(35A) of title 11 of the United States Code and of any similar provisions of Applicable Laws and Regulations under any other jurisdiction (the “Bankruptcy Code”)). The licensee Party shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against a Party under the Bankruptcy Code or analogous provisions of applicable Law outside the United States, the other Party shall be entitled to a complete duplicate of (or complete access to, as appropriate) any intellectual property licensed to such Party and all embodiments of such intellectual property, which, if not already in such Party’s possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon such Party’s written request therefor, unless the Party in the bankruptcy proceeding (x) elects to continue to perform all of its obligations under this Agreement on or before any deadline for making such election and (y) does not reject this Agreement or (b) if not delivered under clause (a), following the rejection of this Agreement by the Party in the bankruptcy proceeding upon written request therefor by the other Party. AMAG and Norgine agree that all payments due from Norgine to AMAG shall be considered “royalty payments” as that term is understood under Section 365(n) of the Bankruptcy Code for purposes of that section. In the event AMAG is the Party in the bankruptcy proceeding and rejects this Agreement, and Norgine elects to retain its rights under this Agreement, Norgine shall make all such payments, including without limitation all product royalties set forth in Section 6.4, all Regulatory Milestone Payments and all Sales Milestone Payments due under this Agreement, for the duration of the applicable Royalty Term. Nothing in this Section 8.7 shall be deemed any admission that this Agreement is an executory contract or that this Agreement or any obligation hereunder is otherwise subject to rejection or disavowal in the bankruptcy, liquidation, reorganization, receivership, assignment for the benefit of creditors, administration, insolvency or similar proceeding or circumstance of a licensor Party, nor any admission that upon any such proceeding or circumstance involving such licensor Party, or upon any such rejection or disavowal by such licensor Party, the licensee Party (or any Affiliate or Sublicensee thereof) would lose or not be able to enforce or benefit from any right hereunder (or under any applicable sublicense).

9.    Confidentiality; Publication

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9.1    Nondisclosure Obligation.

(a)    Definition and Restrictions. All Confidential Information disclosed by one Party to the other Party at any time, including before the Effective Date or after the expiration or termination of this Agreement, shall be maintained in confidence by the receiving Party and shall not be disclosed by the receiving Party to any Third Party or used by the receiving Party for any purpose except as set forth herein without the prior written consent of the disclosing Party, during the Term and for a period of [***] thereafter, provided that with respect to any Confidential Information of a Party that constitutes a trade secret, such confidentiality and non-use obligations shall continue beyond such [***] period for so long as such information constitutes a trade secret under Applicable Laws and Regulations. The following shall not be deemed Confidential Information for purposes of the restrictions set forth in this Section 9.1(a):

(i)    Information that is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by the receiving Party’s business records;

(ii)    Information that is or becomes part of the public domain through no fault of the receiving Party;

(iii)    Information that is subsequently disclosed to the receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality to the disclosing Party; and

(iv)    Information that is developed by the receiving Party independently of Confidential Information received from the disclosing Party, as documented by the receiving Party’s business records.

(b)    Combinations. Any combination of features or disclosures shall not be deemed to fall within the exclusions set forth in Section 9.1(a) merely because individual features are published or available to the general public or in the rightful possession of the receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the receiving Party.

(c)    Permitted Disclosures. Notwithstanding the restrictions set forth in Section 9.1(a), the receiving Party may disclose Confidential Information of the other Party to:

(i)    governmental or other regulatory agencies in order to obtain Patents or to gain or maintain approval to conduct clinical trials or to market the Product, but such disclosure may be only to the extent reasonably necessary to obtain Patents or approvals; or

(ii)    as the receiving Party deems necessary to be disclosed, to its Affiliates, agents, consultants, or other Third Parties for the Development, Manufacture (with respect to Norgine, to the extent permitted pursuant to the terms of this Agreement) or Commercialization of the Product, or in connection with a licensing transaction or contractual obligation related to the Product (including obtaining insurance coverage) or loan, financing or

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investment or acquisition, merger, consolidation or similar transaction (or for such entities to determine their interest in performing such activities or to determine their rights and obligations as a result of completing such transactions) or in order to perform its obligations or exercise its rights under this Agreement, in each case on the condition that any Third Parties, other than Regulatory Authorities, to whom such disclosures are made agree to be bound by confidentiality and non-use obligations substantially similar to those contained in this Agreement; provided that the term of confidentiality may be of shorter duration if customary given the nature of such Person (i.e., investors, lenders and banking institutions).

(d)    Disclosure Required by Judicial or Administrative Process. If a Party is required by judicial or administrative process to disclose Confidential Information of the other Party that is subject to the non-disclosure provisions of this Section 9.1, such Party shall, to the extent legally permissible, promptly inform the other Party of the disclosure that is being sought in order to provide the other Party an opportunity to challenge or limit the disclosure obligations. Confidential Information that is disclosed by judicial or administrative process shall remain otherwise subject to the confidentiality and non-use provisions of this Section 9.1, and the Party disclosing Confidential Information pursuant to law or court order shall use reasonable efforts, including to obtain an order of confidentiality, to ensure the continued confidential treatment of such Confidential Information.

(e)    Obligations Upon Termination. Upon the termination or expiration of this Agreement, or upon the earlier request of either Party, the receiving Party shall return to the disclosing Party, all of the disclosing Party’s Confidential Information, including all copies thereof, provided that the receiving Party may retain one copy for archival purposes, and provided further, that a receiving Party shall not be required to destroy electronic files containing such Confidential Information of the disclosing Party that are made in the ordinary course of its business information back-up procedures pursuant to its electronic record retention and destruction practices that apply to its own general electronic files and information, and any such retained copies shall continue to be subject to the confidentiality and non-use obligations in accordance with this Agreement.

9.2    Publication.

(a)    Publication of Results. Norgine and AMAG each acknowledge the other Party’s interest in publishing the results of its activities under the Agreement in order to obtain recognition within the scientific community and to advance the state of scientific knowledge. Each Party also recognizes the mutual interest in obtaining valid patent protection and in protecting business interests and trade secret information. Except for disclosures permitted pursuant to Section 9.1, either Party and its employees wishing to make a publication related to work performed under this Agreement shall deliver to the other Party a copy of the proposed publication for review pursuant to Section 9.2(b).

(b)    Submission; Review. The Party seeking to publish results hereunder (the “Publishing Party”) shall provide the other Party (the “Reviewing Party”) with a copy of such proposed abstract, manuscript, or presentation no less than [***] in the case of abstracts) prior to its intended submission for publication. The Reviewing Party shall respond in writing promptly

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and in no event later than [***] in the case of abstracts)after receipt of the proposed material, with one or more of the following:

(i)    comments on the proposed material, which the Publishing Party shall consider in good faith;

(ii)    a specific statement of concern, based upon the need to seek patent protection or to block publication if the Reviewing Party determines that the proposed disclosure is intellectual property that should be maintained as a trade secret to protect any activities conducted under this Agreement; or

(iii)    an identification of the Reviewing Party’s Confidential Information that is contained in the material reviewed.

(c)    Patent and Trade Secret Protection. In the event of concern by the Reviewing Party over patent protection or whether maintaining a trade secret would be a priority, the Publishing Party agrees not to submit such publication or to make such presentation that contains such information until the Party that owns the trade secret is given [***] to seek patent protection for any material in such publication or presentation which it believes is patentable with the Party owning such trade secret also retaining the final decision to instead abandon such proposed publication or presentation and maintain such information as a trade secret. Any Confidential Information of the Reviewing Party shall, if requested by the Reviewing Party, be removed.

(d)    Review of Third Party Materials. With respect to any proposed abstracts, manuscripts or summaries of presentations by investigators or other Third Parties conducting activities under this Agreement with or on behalf of a Party, such materials shall be subject to review by the other Party under this Section 9.2 to the same extent that such Party has the right to do so.

9.3    Publicity; Use of Names.

(a)    Press Releases. The Parties shall issue a mutually acceptable press release announcing the execution of this Agreement. A Party may issue any subsequent press release relating to this Agreement or activities conducted hereunder upon prior written approval of the other Party, such approval not to be unreasonably withheld or delayed or conditioned. Notwithstanding the foregoing, no approval of the other Party shall be required for a Party’s release of subsequent press releases or securities filings solely disclosing (i) that a milestone under this Agreement has been achieved or any payments associated therewith have been received; (ii) that the filing or approval of an MAA has occurred in the Norgine Territory (provided, however, that specific dates of filing shall not be disclosed); (iii) that commercial launch of the Product in the Norgine Territory has occurred; or (iv) any information that has previously been approved and disclosed as permitted by this Section 9.3(a). For the avoidance of doubt, nothing herein shall serve to prevent or limit AMAG’s ability to issue press releases or other public disclosure with respect to the Development, Commercialization, Manufacture or other exploitation of the Product in or for the AMAG Territory, provided that no Confidential

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Information of Norgine is disclosed unless specifically permitted under other provisions of this Agreement. For the avoidance of doubt, nothing herein shall serve to prevent or limit Norgine’s ability to issue press releases or other public disclosure with respect to the Development, Commercialization, Manufacture or other exploitation of the Product in or for the Norgine Territory, provided that no Confidential Information of AMAG is disclosed unless specifically permitted under other provisions of this Agreement.

(b)    No Other Use of Company Names. Neither Party shall use the name, trademark, trade name or logo of the other Party or its employees in any publicity or news release relating to this Agreement or its subject matter without the prior express written permission of the other Party, except under Sections 9.3(a), 9.3(c) or 9.3(d) or otherwise as reasonably necessary to identify the relationship between the Parties established by this Agreement.

(c)    Approved Press Releases. In addition and notwithstanding anything to the contrary herein, (i) if the relevant text of a proposed press release has already previously been reviewed and approved for disclosure by the other Party then such text may be disclosed or republished in such proposed press release provided that the Party issuing such press release provides notice to the other Party of such press release at least [***] prior to the issuance of such press release, where practicable, and (ii) if the relevant text of a proposed public announcement such as a corporate presentation or comments to analysts or investors has already previously been reviewed and approved for disclosure by the other Party (whether in the form of an approved press release or prior approved presentation materials, Q&A script or the like) then such text may be included in such proposed public announcement (but not a press release) without resubmission and review by the other Party.

(d)    Existence of Agreement.

(i)    No Disclosure. Neither Party shall disclose the existence or terms of this Agreement pursuant to a press release or otherwise except as provided in this Section 9.3(d).

(ii)    Permitted Disclosures.

(A)    Notwithstanding the terms of this Article 9, either Party shall be permitted to disclose the existence and terms of this Agreement and the conduct of activities hereunder to the extent required, in the reasonable opinion of such Party’s legal counsel, to comply with Applicable Laws and Regulations, including the rules and regulations promulgated by the United States Securities and Exchange Commission or any other governmental agency or pursuant to the rules of any recognized stock exchange, and as reasonably necessary to register licenses granted hereunder with relevant patent or other government agencies. The disclosing Party shall take reasonable and lawful actions to avoid or minimize the degree of such disclosure.

(B)    Either Party may also disclose the existence and terms of this Agreement to its attorneys, accountants and advisors, insurers or insurance agents, and to

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potential acquirors, in connection with a potential acquisition or other change of control transaction and to existing and potential investors or lenders of such Party, as a part of their due diligence investigations, or to potential licensees or sublicensees or to potential and current permitted assignees in each case under an agreement to keep the terms of this Agreement confidential under terms of confidentiality and non-use substantially similar to the terms contained in this Agreement, provided that the term of confidentiality may be of shorter duration if customary given the nature of such Person (i.e., investors, lenders and banking institutions) and to use such confidential information solely for the purpose of the contemplated transaction.

(C)    AMAG may also disclose the existence and terms of this Agreement pursuant to transactions related to the research, Development, Manufacture or Commercialization or exploitation of the Product (“Licensing Transactions”), in each case under an agreement to keep the terms of this Agreement confidential under terms of confidentiality and non-use substantially similar to the terms contained in this Agreement and to use such confidential information solely for the purpose of the contemplated transaction. The transactions described in Section 9.3(d)(ii)(B) shall not be deemed Licensing Transactions for purposes of this Section 9.3(d)(ii)(C).

10.    Representations and Warranties

10.1    Representations and Warranties of AMAG. AMAG represents and warrants to Norgine that as of the Effective Date:

(a)    it has the full right, power and authority to enter into this Agreement, to perform its obligations hereunder, and to grant the licenses contemplated under Article 8, and the fulfillment of its obligations and performance of its activities hereunder do not materially conflict with, violate, or breach or constitute a default under any contractual obligation or court or administrative order by which AMAG is bound;

(b)    all necessary consents, approvals and authorizations of all government authorities and other persons required to be obtained by AMAG as of the Effective Date in connection with the execution, delivery and performance of this Agreement have been obtained;

(c)    it Controls the right, title and interest in and to the AMAG Licensed Technology, and has the right to grant to Norgine the licenses under the AMAG Licensed Patents that it purports to grant hereunder and has not granted any Third Party rights under such AMAG Licensed Technology that would interfere or be inconsistent with Norgine’s rights hereunder;

(d)    Exhibit A sets forth a complete and accurate list of all AMAG Licensed Patents Controlled by AMAG and/or its Affiliates, indicating the owner, licensor and/or co-owner(s), if applicable. Except as set forth on Exhibit A, AMAG and its Affiliates do not own, or have a license to, any Patent that claims or covers the Product, or that otherwise are necessary or useful to research, Develop, Manufacture or Commercialize the Product;

(e)    Schedule 10.1(e) sets forth a complete and accurate list of all agreements relating to the licensing, sublicensing or other granting of rights with respect to the AMAG

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Licensed Technology or the Product to which AMAG or any of its Affiliates is a party and which is necessary or useful to research, Develop, Manufacture or Commercialize the Product, and AMAG has provided complete and accurate copies of all such agreements to Norgine (the “AMAG Agreements”), which copies were redacted only as to terms not relevant to the rights to be sublicensed, restrictions on the exploitation of such sublicensed rights, and Norgine’s performance as a sublicensee thereunder. Except under the AMAG Agreements or the [***], AMAG and its Affiliates are not subject to any payment obligations to Third Parties as a result of the execution or performance of this Agreement. AMAG and its Affiliates are not in material breach of any AMAG Agreement pursuant to which AMAG and/or its Affiliates receive a license or sublicense to any AMAG Licensed Technology. As between the Parties, AMAG shall be solely responsible for any payment obligations to Third Parties pursuant to any AMAG Agreement;

(f)    neither AMAG nor any of its Affiliates has granted any liens or security interests on the AMAG Licensed Technology and the AMAG Licensed Technology is free and clear of any mortgage, pledge, claim, security interest, covenant, easement, encumbrance, lien or charge of any kind;

(g)    there is not any action, suit, inquiry, investigation or other proceeding pending or ongoing brought by or, to the knowledge of AMAG, threatened by, any Third Party that challenges or threatens the validity or enforceability of any of the AMAG Licensed Patents or that alleges the use of the AMAG Licensed Patents or the Development, Manufacture, Commercialization, and use of the Product would infringe intellectual property rights of any Third Party (and it has not received any notice alleging such an infringement), and it has no knowledge of any factual, legal or other reasonable basis relating to any such litigation, claim or proceeding. In the event that AMAG receives written notice of any such action or proceeding, it shall notify Norgine in writing;

(h)    to the knowledge of AMAG, there are no inventorship challenges, inter partes proceedings, opposition or nullity proceedings or interferences declared, commenced or provoked or threatened, with respect to the AMAG Licensed Patents;

(i)    to the knowledge of AMAG, AMAG has (i) complied with its duty of candor and disclosure to the United States Patent and Trademark Office and any relevant foreign patent office with respect to all patent and trademark applications filed by or on behalf of AMAG and (ii) made no material misrepresentation in such applications;

(j)    to the knowledge of AMAG, neither the Product nor the Manufacture, Development, or Commercialization thereof by AMAG or the performance of the activities contemplated by Norgine hereunder, infringes or will infringe any issued patent of any Third Party or will infringe the claims of any published Third Party patent application when and if such claims issue or does or will misappropriate or otherwise violate any other intellectual property rights of any Third Party;

(k)    to the knowledge of AMAG, no Third Party is infringing, misappropriating or otherwise violating any AMAG Licensed Technology;

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(l)    to the knowledge of AMAG, there have been no material safety issues relating to the Product;

(m)    all data, information and materials, including, but not limited to, AMAG Licensed Know-How, provided or disclosed to Norgine by AMAG prior to the Effective Date relating to non-clinical and clinical studies of the Product are to the knowledge of AMAG, accurate in all material respects, and neither AMAG nor any of its Affiliates has intentionally withheld or concealed from (i) Norgine any adverse events relating to the Product or (ii) any Regulatory Authority in any country any material adverse information known to AMAG or any of its Affiliates in relation to the Product;

(n)    AMAG and its Affiliates have generated, prepared, maintained and retained all data and regulatory documentation, including safety issue, signal and information that is required to, be generated, maintained or retained pursuant to Applicable Laws and Regulations, including GCP, GLP and GMP, relating to the Product with such Applicable Laws and Regulations in all material aspects, and all such data and regulatory documentation, including safety issue, signal and information provided or disclosed to Norgine by AMAG prior to the Effective Date are, to the knowledge of AMAG, true, complete and correct in all material respects; and

(o)    neither AMAG nor its Affiliates, nor any of its or their respective directors, officers, employees or agents has (a) committed an act, (b) made a statement or (c) failed to act or make a statement, in any case ((a), (b) or (c)), that, at the time such statement, action, or omission occurred, (x) was an untrue or fraudulent statement of material fact to the FDA or any other Regulatory Authority with respect to Development, Manufacture, having Manufactured, use or Commercialization of the Product or (y) would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto or any analogous laws or policies, with respect to Development, Manufacture, having Manufactured, use or Commercialization of the Product; and no fact or circumstance has come to the attention of AMAG that would reasonably be expected to result in any such statement, action or omission, if it occurred as of the Effective Date, to fall within (a) or (b) above.

10.2    Representations and Warranties of Norgine. Norgine represents and warrants to AMAG that as of the Effective Date:

(a)    it has the full right, power and authority to enter into this Agreement, to perform its obligations hereunder, to grant the licenses granted hereunder, and the fulfillment of its obligations and performance of its activities hereunder do not materially conflict with, violate, or breach or constitute a default under any contractual obligation or court or administrative order by which Norgine is bound;

(b)    all necessary consents, approvals and authorizations of all government authorities and other persons required to be obtained by Norgine as of the Effective Date in

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connection with the execution, delivery and performance of this Agreement have been obtained; and

(c)    no Norgine Licensed Patents or Norgine Licensed Know-How exist as of the Effective Date that are or would be necessary for the Development, Manufacture or Commercialization of the Product.

10.3    Covenants of the Parties. Each Party shall conduct all activities under this Agreement in compliance with: (i) the terms and conditions of this Agreement; and (ii) all Applicable Laws and Regulations.

10.4    No Other Representations or Warranties. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, IS MADE OR GIVEN BY OR ON BEHALF OF A PARTY. ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.

11.    Indemnification

11.1    By Norgine. Norgine agrees to indemnify and hold harmless AMAG, its Affiliates, and their directors, officers, employees and agents (individually and collectively, the “AMAG Indemnitee(s)”) from and against all losses, liabilities, damages and expenses (including reasonable attorneys’ fees and costs) incurred in connection with any claims, demands, actions or other proceedings by any Third Party (individually and collectively, “Losses”) first arising after the Effective Date to the extent arising from (a) activities by Norgine or any of its Affiliates, Sublicensees or Distributors with respect to the research, Development, use, Commercialization, Manufacture (when exercising its license to Manufacture), import, distribution, or sale of the Product or any other exercise of their rights or performance of their obligations hereunder, or (b) the negligence, illegal conduct or willful misconduct of Norgine or its Affiliates, or (c) Norgine’s breach of this Agreement, except to the extent such Losses arise out of any of AMAG Indemnitee’s negligence, illegal conduct or willful misconduct, or breach of this Agreement or are required to be indemnified under Section 11.2.

11.2    By AMAG. In addition to its obligations under Section 11.4, AMAG agrees to indemnify and hold harmless Norgine, its Affiliates, and their directors, officers, employees and agents (individually and collectively, the “Norgine Indemnitee(s)”) from and against all Losses to the extent arising from (a) activities by AMAG or any of its Affiliates, Licensees or distributors with respect to the research, Development, use, Commercialization, import, distribution, or sale of the Product for the purpose of Commercialization or sale of the Product outside the Norgine Territory or any other exercise of their rights or performance of their obligations hereunder, (b) the negligence, illegal conduct or willful misconduct of AMAG or its Affiliates, (c) AMAG’s breach of this Agreement, or (d) any product liability claims asserted or filed by a Third Party related to the Product based on the negligence, willful misconduct or

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breach of this Agreement, except to the extent such Losses arise out of any of Norgine Indemnitee’s negligence, illegal conduct or willful misconduct, or breach of this Agreement or are required to be indemnified under Section 11.1.

11.3    Procedure and Conditions to Indemnification.

(a)    Notice of Claim. All indemnification claims in respect of any Indemnitee seeking indemnity under this Article 11 will be made solely by the corresponding Party seeking indemnity hereunder (the “Indemnified Party”). The Indemnified Party shall give the indemnifying party (the “Indemnifying Party”) prompt written notice (an “Indemnification Claim Notice”) of any Losses or the discovery of any fact upon which such Indemnified Party intends to base a request for indemnification under Section 11.1 or 11.2, as applicable, and in no event will the Indemnifying Party be liable for any Losses that result from any delay by the Indemnified Party in providing such notice. Notice must contain a description of the claim and the nature and amount of such Loss (to the extent that the nature and amount of such Loss are known at such time). Together with the Indemnification Claim Notice, the Indemnified Party will furnish promptly to the Indemnifying Party copies of all notices and documents (including court papers) received by the Indemnified Party in connection with the claim.

(b)    Assumption of Defense. At its option, the Indemnifying Party may assume the defense of any claim subject to indemnification as provided for in Section 11.1 or 11.2 (and not, for clarity, any claim subject to indemnification as provided for in Section 11.4) by giving written notice to the Indemnified Party within [***] after the Indemnifying Party’s receipt of an Indemnification Claim Notice, providedhoweverthat (i) the claim solely seeks monetary damages and (ii) the Indemnifying Party expressly agrees in writing that as between the Indemnifying Party and the Indemnified Party, the Indemnifying Party shall be solely obligated to satisfy and discharge the claim in full (the matters described in (i) and (ii), the “Litigation Conditions”). Upon assuming the defense of a claim in accordance with this Section 11.3(b), the Indemnifying Party shall be entitled to appoint lead counsel in the defense of the claim. Should the Indemnifying Party assume the defense of a claim, except as otherwise set forth in this Section 11.3(b), the Indemnifying Party shall not be liable to the Indemnified Party for any legal expenses subsequently incurred by such Indemnified Party in connection with the analysis, defense or settlement of the claim. The Indemnified Party may, at any time, assume the defense of a claim subject to indemnification as provided for in Section 11.1 or 11.2 if at any time the Litigation Conditions are not satisfied with respect to such claim.

(c)    Participation. Without limiting Section 11.3(b), any Indemnified Party will be entitled to participate in, but not control, the defense of a claim for which it has sought indemnification under Section 11.1 or 11.2 and to employ counsel of its choice for such purpose; providedhoweverthat such employment will be at the Indemnified Party’s own expense unless (i) the employment thereof has been specifically authorized by the Indemnifying Party in writing, or (ii) the Indemnifying Party has failed to assume and actively further the defense and employ counsel in accordance with Section 11.3(b) (in which case the Indemnified Party will control the defense), or (c) the Indemnifying Party no longer satisfies the Litigation Conditions.

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(d)    Consent. With respect to any Losses relating solely to the payment of money damages in connection with a claim that will not result in the Indemnified Party’s becoming subject to injunctive or other relief or otherwise adversely affect the business of the Indemnified Party in any manner, and as to which the Indemnifying Party will have acknowledged in writing the obligation to indemnify the Indemnified Party hereunder, and subject to the Litigation Conditions being satisfied, the Indemnifying Party will have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss, on such terms as the Indemnifying Party, in its reasonable discretion, will deem appropriate (providedhoweverthat such terms shall include a complete and unconditional release of the Indemnified Party from all liability with respect thereto), and will transfer to the Indemnified Party all amounts which said Indemnified Party will be liable to pay prior to the time of the entry of judgment. With respect to all other Losses in connection with claims, where the Indemnifying Party has assumed the defense of the claim in accordance with Section 11.3(b), the Indemnifying Party will have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss provided it obtains the prior written consent of the Indemnified Party (which consent shall not be unreasonably withheld). The Indemnifying Party that has assumed the defense of the claim in accordance with Section 11.3(b) will not be liable for any settlement or other disposition of a Loss by an Indemnified Party (but in no event to include any court judgment or judicial or administrative order or disposition) that is reached without the written consent of such Indemnifying Party for such claim, and no Indemnified Party will admit any liability with respect to, or settle, compromise or discharge, any claim without first offering to the Indemnifying Party the opportunity to assume the defense of the claim in accordance with Section 11.3(b).

(e)    Cooperation. If the Indemnifying Party chooses to defend or prosecute any claim in accordance with Section 11.3(b), the Indemnified Party will cooperate in the defense or prosecution thereof and will furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection with such claim. Such cooperation will include access during normal business hours afforded to the Indemnifying Party to, and reasonable retention by the Indemnified Party of, records and information that are reasonably relevant to such claim, and making employees and agents available on a mutually convenient basis to provide additional information and explanation of any materials provided hereunder, and the Indemnifying Party will reimburse the Indemnified Party for all of its reasonable out-of-pocket expenses incurred in connection with such cooperation.

(f)    Costs. Except as provided above, the reasonable and verifiable costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in connection with any claim will be reimbursed on a Calendar Quarter basis by the Indemnifying Party, without prejudice to the Indemnifying Party’s right to contest the Indemnified Party’s right to indemnification and subject to refund in the event the Indemnifying Party is ultimately held not to be obligated to indemnify the Indemnified Party.

(g)    Multiple Claims. For the avoidance of doubt, a single suit, action, proceeding or demand may include multiple claims. In the event any such suit, action, proceeding or

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demand requires the defense of both (i) an indemnified claim for which the Indemnifying Party has assumed the defense in accordance with Section 11.3(b) and (ii) (A) an indemnified claim for which the Indemnified Party controls the defense settlement; (B) claims for which each Party is required to indemnify the other Party; and/or (C) a claim not subject to indemnification under Section 11.1 or Section 11.2, as applicable, for which a Party retains the right to control the defense, then (1) the Parties shall reasonably cooperate in the defense and settlement of such claims (except to the extent where such cooperation would present a conflict of interest), including as required under Section 11.3(e) and (2) without limitation of Section 11.4, the Indemnifying Party shall only be required to indemnify the Indemnified Party for the claim(s) that are subject to indemnification in accordance with Section 11.1 or Section 11.2, as applicable. For purposes of clarity, a Party shall not be required to seek the consent of the other Party in the settlement of any non-indemnified claim.

11.4    Product Liability Claims.

(a)    [***].

(b)    Norgine shall promptly notify AMAG in the event that any Third Party asserts or files any claim or other action against a Norgine Indemnitee relating to alleged bodily injury or property damage resulting from or relating to the use of the Product in a human (whether design defects or manufacturing defects) (“ThirdParty Products Liability Action”).

(c)    The Parties shall reasonably cooperate with each other in the preparation and formulation of a defense to such Third Party Products Liability Action, and in taking other steps reasonably necessary to respond to such Third Party Products Liability Action. [***] shall have the right to select its counsel for the defense to such Third Party Products Liability Action, which counsel must be reasonably acceptable to [***].

(d)    Each Party shall maintain, at its cost, insurance against liability and other risks associated with its activities and obligations under this Agreement, including Product Liabilities, with a minimum policy amount of [***] during the Term and for at least [***] thereafter. Each Party shall furnish to the other Party evidence of such insurance upon request, and shall list the other Party as an additional insured with respect to the liabilities arising pursuant to this Section 11.4.

11.5    Limitation of Liability.NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES OR FOR LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. [***].

12.    Inventions; Intellectual Property Provisions

12.1    Ownership of Intellectual Property.

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(a)    Ownership of AMAG IP. As between AMAG and Norgine, AMAG shall remain the sole and exclusive owner of all AMAG Licensed Patents, AMAG Licensed Trademarks and AMAG Licensed Know-How that (i) exist as of the Effective Date; or (ii) that come into existence after the Effective Date.

(b)    Ownership of Norgine IP. As between Norgine and AMAG, Norgine shall remain the sole and exclusive owner of all Norgine Licensed Patents and Norgine Licensed Know-How that (i) exist as of the Effective Date; or (ii) that come into existence after the Effective Date.

(c)    Ownership of Program IP. AMAG shall own all Know-How, Clinical Data, and inventions, whether patentable or not, conceived or reduced to practice in the course of conducting activities hereunder, together with all intellectual property rights therein, that are invented solely by AMAG, its Affiliates or its or its Affiliates’ respective consultants or subcontractors, solely by Norgine or its Affiliates or its or its Affiliates’ respective consultants or subcontractors, or jointly by AMAG (or its Affiliates or its or its Affiliates’ respective Sublicensees, consultants or subcontractors) on the one hand and Norgine (or its Affiliates or its or its Affiliates’ respective consultants or subcontractors) on the other hand (“AMAG Program IP”). Norgine hereby assigns, transfers and conveys (and to the extent a present assignment is prohibited by Applicable Laws and Regulations, shall assign) to AMAG all of Norgine’s (and its Affiliates’ and Sublicensees’) right, title and interest in and to such AMAG Program IP. Notwithstanding the foregoing, Norgine shall own all Know-How, Clinical Data, and inventions, whether patentable or not, conceived or reduced to practice, together with all intellectual property rights therein, whether invented solely by AMAG, its Affiliates or its or its Affiliates’ respective consultants or subcontractors, solely by Norgine or its Affiliates or its or its Affiliates’ respective consultants or subcontractors, or jointly by AMAG (or its Affiliates or its or its Affiliates’ respective Sublicensees, consultants or subcontractors) on the one hand and Norgine (or its Affiliates or its or its Affiliates’ respective consultants or subcontractors) on the other hand, that arise from a Regulator-Requested Trial (“Norgine Program IP”). AMAG hereby assigns, transfers and conveys (and to the extent a present assignment is prohibited by Applicable Laws and Regulations, shall assign) to Norgine all of AMAG’s (and its Affiliates’ and Sublicensees’) right, title and interest in and to such Norgine Program IP.

12.2    Patent and Trademark Prosecution and Defense.

(a)    Prosecution.

(i)    The responsibility for Patent Prosecution and Defense and Trademark Prosecution and Defense related to a Patent or Trademark that is within the AMAG Licensed Patents or AMAG Licensed Trademarks or the Norgine Licensed Patents that is owned solely by a Party shall be the responsibility of such Party. Such Party shall keep the JSC and the other Party informed of the status of all such Patent Prosecution and Defense and Trademark Prosecution and Defense activities.

(ii)    AMAG shall keep the JSC and Norgine informed of the status of all matters affecting Patent Prosecution and Defense and Trademark Prosecution and Defense of

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AMAG Licensed Patents or AMAG Licensed Trademarks in the Norgine Territory, including providing a copy of any correspondence from any governmental authorities to the JSC and Norgine upon request, and consulting on the strategy and content of submissions to such governmental authorities in advance of any submissions. If AMAG decides not to file, prosecute, maintain, extend or defend a AMAG Licensed Patent or AMAG Licensed Trademark, in each case, in the Norgine Territory, it shall give Norgine reasonable notice to that effect sufficiently in advance of, but not less than [***] prior to, any deadline for any filing with respect to such AMAG Licensed Patent or AMAG Licensed Trademark to permit Norgine to carry out such activity. After such notice, Norgine may file, prosecute, maintain, extend or defend such AMAG Licensed Patent or AMAG Licensed Trademark, and perform such acts as may be reasonably necessary for it to file, prosecute, maintain, extend or defend such AMAG Licensed Patent or AMAG Licensed Trademark [***]. If Norgine does so elect, then AMAG shall [***], provide such cooperation to Norgine, including the execution and filing of appropriate instruments, as may reasonably be requested [***].

(iii)    Norgine shall keep the JSC and AMAG informed of the status of all matters affecting Patent Prosecution and Defense of Norgine Licensed Patents on a worldwide basis and Trademark Prosecution and Defense of Norgine Controlled Trademarks in the Norgine Territory, including providing a copy of any correspondence from any governmental authorities to the JSC and AMAG upon request, and consulting on the strategy and content of submissions to such governmental authorities in advance of any submissions. If Norgine decides not to file, prosecute, maintain, extend or defend a Norgine Licensed Patent anywhere in the world or a Norgine Controlled Trademark in the Norgine Territory, it shall give AMAG reasonable notice to that effect sufficiently in advance of, but not less than [***] prior to, any deadline for any filing with respect to such Patent or Trademark to permit AMAG to carry out such activity. After such notice, AMAG may file, prosecute, maintain, extend or defend such Patent or Trademark and perform such acts as may be reasonably necessary for it to file, prosecute, maintain, extend or defend such Patent or Trademark[***]. If AMAG does so elect, then Norgine shall provide such cooperation to AMAG, including the execution and filing of appropriate instruments, as may reasonably be requested [***].

(iv)    Any Dispute regarding Patent Prosecution and Defense and Trademark Prosecution and Defense of AMAG Licensed Patents, Norgine Licensed Patents or AMAG Licensed Trademarks that cannot be resolved by intellectual property counsel of the Parties, may be submitted by the other Party for Dispute resolution pursuant Article 13.

(v)    Norgine rights and obligations under this Section 12.2 are secondary to and shall be subject to any Third Party rights and obligations under the applicable AMAG Third Party Agreement.

(b)    Patent Invalidations. AMAG shall decide whether and how to undertake activities intended to invalidate pending or issued Third Party Patents in the Norgine Territory that relate to the Product. If AMAG decides not to undertake such activities or ceases undertaking such activities, then Norgine shall have the right to undertake activities that it

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reasonably determines are necessary to invalidate pending or issues Third Party Patents in the Norgine Territory.

(c)    Patent Extensions; Listings. AMAG will reasonably cooperate with Norgine, including providing reasonable assistance to Norgine (including executing any documents and making such filings as may reasonably be required), in Norgine’s efforts [***] to seek and obtain patent term restoration or supplemental protection certificates or the like or their equivalents in any country in the Norgine Territory, where applicable to AMAG Licensed Patents or any other applicable Patents. To the extent applicable with respect to the Product, Norgine will have the sole right to list, with the applicable Regulatory Authorities in the Norgine Territory, all applicable Patents (including any AMAG Licensed Patents) for the Product, and AMAG will have the sole right to list, with the applicable Regulatory Authorities in the AMAG Territory, all applicable Patents (including any Norgine Licensed Patents) for the Product.

12.3    Costs of Patent and Trademark Prosecution and Defense.

(a)    [***]

(b)    [***]

(c)    Reconciliation/Reimbursement. Within [***] after the end of each Calendar Quarter during which either Party incurs any costs that should be properly borne by the other Party pursuant to this Section 12.3 (“Reimbursable IP Costs”), such Party shall submit to a finance officer designated by the other Party a good faith estimate of such Reimbursable IP Costs it incurred in such Calendar Quarter.  Within [***] following the end of such quarter, such Party shall update such report to reflect the final amount of Reimbursable IP Costs incurred by it in such Calendar Quarter.  Such report shall specify in reasonable detail all such costs and shall include reasonably detailed supporting documentation, and, any additional documentation reasonably requested by the other Party shall be promptly provided.  Each Party shall (or any of its Affiliates shall) reimburse the other Party for such Reimbursable IP Costs within [***] after receipt of the final report with respect thereto.

12.4    Patent and Trademark Prosecution and Defense Cooperation. With respect to all Patent Prosecution and Defense and Trademark Prosecution and Defense related to pending or issued Patents and Trademarks included in AMAG Licensed Patents in the Norgine Territory, AMAG Licensed Trademarks in the Norgine Territory or Norgine Licensed Patents, each Party shall:

(a)    execute all further instruments to document their respective ownership consistent with this Agreement as reasonably requested by the other Party;

(b)    make its employees, agents and consultants reasonably available to the other Party (or to the other Party’s authorized attorneys, agents or representatives), to the extent reasonably necessary to enable the appropriate Party hereunder to undertake its Patent Prosecution and Defense and Trademark Prosecution and Defense responsibilities;

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(c)    cooperate, if necessary and appropriate, with the other Party in gaining Patent and Trademark term extensions; and

(d)    endeavor in good faith to coordinate its efforts under this Agreement with the other Party to minimize or avoid interference with the Patent Prosecution and Defense and Trademark Prosecution and Defense of the other Party’s Patents and Trademarks.

In addition, at Norgine’s request, AMAG agrees to render reasonable assistance for registration by Norgine of the licenses granted under this Agreement with relevant patent offices and other government agencies in the Norgine Territory, including providing Norgine with any documents duly signed by authorized personnel of AMAG which are reasonably requested by Norgine and necessary to effect such registration.

12.5    Enforcement.

(a)    Notice. Promptly, but in no event later than [***] after becoming aware of actual or alleged infringement in the Norgine Territory of any Patent or Trademark Controlled by the other Party and subject to a license under Sections 8.1 or 8.2, the applicable Party shall provide the other Party with written notice reasonably detailing such infringement.

(b)    Enforcement of Intellectual Property Rights.

(i)    Except as provided below, the sole owner of a Patent, Trademark, Know-How or Confidential Information shall have the exclusive right to institute and direct legal proceedings against any Third Party believed to be infringing such Patent or Trademark or misappropriating or otherwise violating such Know-How or Confidential Information.

(ii)    If AMAG fails to or elects not to initiate a proceeding within [***] after written notice of an actual or suspected infringement by a Competitive Product in the Norgine Territory of any Patent or Trademark Controlled by AMAG, or misappropriation or other violation of Know-How or Confidential Information Controlled by AMAG, and in each case subject to a license under Section 8.1 (“Competitive Infringement”) is first provided by Norgine (or such shorter period of time as is required by Applicable Laws and Regulations in the Norgine Territory to not waive any statutory or other rights to enforce such Patent in connection with the Competitive Infringement), Norgine will have the right to initiate and control a proceeding with respect to such Competitive Infringement by counsel of its own choice, [***] and AMAG will have the right, [***] to be represented in any such action by counsel of its own choice.

(iii)    [***].

(c)    Cooperation in Enforcement Proceedings. For any action by a Party pursuant to Section 12.5(b), in the event that such Party is unable to initiate or prosecute such action solely in its own name, the other Party shall join such action voluntarily and shall execute all documents necessary for such Party to initiate, prosecute and maintain such action, [***]. If either Norgine or AMAG initiates an enforcement action pursuant to Section 12.5(b), then the

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other Party shall cooperate to the extent reasonably necessary [***]. Upon the reasonable request of the Party instituting any such action, such other Party shall join the suit and can be represented in any such legal proceedings using counsel of its own choice. Each Party shall assert and not waive the joint defense privilege with respect to all communications between the Parties reasonably the subject thereof.

(d)    Status; Settlement. The Parties shall keep each other informed of the status of and of their respective activities regarding any enforcement action pursuant to Section 12.5(b). Without the other Party’s written authorization (not to be unreasonably withheld, delayed or conditioned), neither Party shall settle any litigation or legal proceeding in the Norgine Territory to enforce (i) AMAG Licensed Patents, (ii) the AMAG Licensed Trademarks or (iii) rights in Know-How or Confidential Information Controlled by AMAG, in each case ((i), (ii) and (iii)) against a Third Party selling a Competitive Product in the Norgine Territory. Norgine will not enter into any settlement of any action described in this Section 12.5(b) that admits to the invalidity, unpatentability, narrowing of scope or unenforceability of the AMAG Licensed Patents or AMAG Licensed Trademarks in any manner, incurs any financial liability on the part of AMAG or requires an admission of liability, wrongdoing or fault on the part of AMAG, in each case without AMAG’s prior written consent, not to be unreasonably withheld, delayed or conditioned.

12.6    Defense Against Third Party Infringement Allegations.

(a)    Notice of Allegations. Each Party shall notify the other in writing of any allegations it receives from a Third Party that the Development, Manufacture, Commercialization, or other exploitation of the Product or the practice of any AMAG Licensed Technology or Norgine Licensed Patents or Norgine Licensed Know-How licensed by a Party under this Agreement infringes the intellectual property rights of such Third Party in the Norgine Territory. Such notice shall be provided promptly, but in no event after more than [***], following receipt of such allegations.

(b)    Notice of Suit. In the event that a Party receives notice that it or any of its Affiliates have been individually or collectively named as a defendant (or defendants) in a legal proceeding by a Third Party alleging infringement of a Third Party’s Patents issued in the Norgine Territory as a result of the Development, Manufacture, Commercialization, or other exploitation of the Product or the practice of any AMAG Licensed Technology or Norgine Licensed Patents or Norgine Licensed Know-How licensed by a Party under this Agreement, such Party shall immediately notify the other Party in writing and in no event notify such other Party later than [***] after the receipt of such notice. Such written notice shall include a copy of any summons or complaint (or the equivalent thereof) received regarding the foregoing. Each Party shall assert and not waive the joint defense privilege with respect to all communications between the Parties reasonably the subject thereof. In such event, the Parties shall agree how best to mitigate or control the defense of any such legal proceeding; provided however, that if either Party or any of its Affiliates have been individually named as a defendant in a legal proceeding relating to the alleged infringement of a Third Party’s issued Patents in the Norgine Territory as a result of the Development, Manufacture, Commercialization, or other exploitation of the Product,

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such Party shall have the right to take such actions that it determines are necessary to defend itself, and the other Party shall be allowed to join in such action [***].

(c)    Status; Settlement. The Parties shall keep each other informed of the status of and of their respective activities regarding any litigation or settlement thereof initiated by a Third Party in the Norgine Territory concerning a Party’s Development, Manufacture, Commercialization, or other exploitation of the Product in the Norgine Territory; provided, however, that no settlement or consent judgment or other voluntary final disposition of a suit under this Section 12.6(c) may be undertaken by a Party without the consent of the other Party, which consent shall not be unreasonably withheld, conditioned or delayed.

12.7    Trademarks.

(a)    Each Party and its Affiliates shall retain all right, title and interest in and to its and their respective corporate names and logos.

(b)    Unless otherwise agreed in writing by the Parties, AMAG shall own (i) the Trademark for all representations of the name and logo of the Product that are used in the AMAG Territory, and (ii) the trade dress related to the Product that is used in the AMAG Territory, each of (i) and (ii) on a worldwide basis.

(c)    Norgine shall own all Trademarks and trade dress with respect to the Product in the Norgine Territory that are not owned by AMAG pursuant to Section 12.7(b) (each, a “Norgine Controlled Trademark”).

(d)    The Party owning a Trademark pursuant to this Section 12.7 shall be exclusively entitled to register and be the owner of the domain names corresponding to or containing such Trademark in any generic Top Level Domains (gTLDs), including the new and to be introduced gTLDs, except that Norgine shall be exclusively entitled to register and be the owner of the domain names corresponding to or containing such Trademark in the Norgine Territory. The Party owning a Trademark shall also own all goodwill associated therewith throughout the world.

(e)    Norgine and its Related Parties shall use Commercially Reasonable Efforts to comply with AMAG’s trademark style and usage standards communicated to Norgine from time to time in connection with Norgine and its Related Parties’ use of the AMAG Licensed Trademarks, provided that if AMAG communicates any changes to such standards, Norgine shall use reasonable efforts to implement such changes if such changes are reasonable and do not require Norgine to incur more than de minimis costs. Norgine and its Related Parties shall not use any AMAG Licensed Trademark to identify any product other than the Product.

(f)    If either Party becomes aware of any infringement of any AMAG Licensed Trademark or Norgine Controlled Trademark by a Third Party, such Party shall promptly notify the other Party. The Parties shall cooperate and inform each other of relevant activities in their respective territory and consider in good faith the other Party’s feedback if there is the potential for an impact to the other Party’s territory.

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13.    Dispute Resolution

13.1    Exclusive Dispute Resolution Mechanism. The Parties agree that the procedures set forth in this Article 13 shall be the exclusive mechanism for resolving any Dispute between the Parties that may arise from time to time pursuant to this Agreement relating to either Party’s rights or obligations hereunder that is not resolved through good faith negotiation between the Parties. For the avoidance of doubt, this Article 13 shall not apply to any decision with respect to which a Party has final decision-making authority hereunder. Any Dispute, including Disputes that may involve the parent company, subsidiaries, or Affiliates under common control of any Party, shall be resolved in accordance with this Article 13.

13.2    Resolution by Executive Officers. Except as otherwise provided in this Article 13, in the event of any Dispute regarding the construction or interpretation of this Agreement or the rights, duties or liabilities of either Party hereunder, the Parties shall first attempt in good faith to resolve such Dispute by negotiation and consultation between themselves by submission to the JSC. In the event that such Dispute is not resolved on such basis within [***] (unless otherwise agreed by the Parties) after being submitted to the JSC, either Party may, by written notice to the other Party, refer the Dispute to the Executive Officer of each Party for attempted resolution by good faith negotiation within [***] after such notice is received (unless otherwise agreed by the Parties). Each Party may, in its discretion, seek resolution of any and all Disputes that are not resolved under this Section 13.2 in accordance with Section 13.3, except for Disputes under Sections 3.2(c) and 5.3, which shall be resolved as set forth therein.

13.3    Courts. If the Parties fail to resolve the Dispute pursuant to Section 13.2, and a Party desires to pursue resolution of the Dispute, the Dispute shall be resolved in the federal courts located in the Southern District of New York. Each Party hereby irrevocably and unconditionally consents to submit to the exclusive jurisdiction of the federal courts located in the Southern District of New York, for any actions, suits or proceedings arising out of or relating to this Agreement and the transactions contemplated hereby. Each Party hereby irrevocably and unconditionally waives any objection to the laying of venue of any action, suit or proceeding arising out of or relating to this Agreement and the transactions contemplated hereby in the federal courts located in the Southern District of New York, and waives and agrees not to plead or claim in any such court that any such action, suit or proceeding brought in such court has been brought in an inconvenient forum. Notwithstanding the foregoing, a Party shall be entitled to seek enforcement of a judgment entered pursuant to this Section in any court having competent jurisdiction thereof where enforcement is deemed necessary.

13.4    Costs of Dispute Resolution. [***].

13.5    No Limitation. Nothing in this Article 13 shall be construed as limiting in any way the right of a Party to seek an injunction or other equitable relief with respect to any actual or threatened breach of this Agreement in a court of competent jurisdiction. Should any Party seek an injunction or other equitable relief, then for purposes of determining whether to grant such injunction or other equitable relief, the dispute underlying the request for such injunction or other equitable relief, may be heard by the court in which such action or proceeding is brought.

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14.    Term and Termination

14.1    Term. Unless earlier terminated, this Agreement shall begin on the Effective Date and continue in effect until the expiration, on a country-by-country basis, of the Royalty Term applicable to such country (“Term”).

14.2    Termination for Challenge to Patent Validity. AMAG may terminate this Agreement immediately upon written notice to Norgine in the event Norgine or any of its Affiliates:

(a)    directly or indirectly oppose, or assist any Third Party to oppose, in any patent office proceeding, the grant of any patent or patent application within the AMAG Licensed Patents, or, in any patent office proceeding, dispute or directly or indirectly assist any Third Party to dispute, the validity of any patent within the AMAG Licensed Patents or any of the claims thereof, including opposing any application for amendment thereto; or

(b)    directly or indirectly oppose, or assist any Third Party to oppose, in any court proceeding, the grant of any patent or patent application within the AMAG Licensed Patents, or, in any court proceeding, dispute or directly or indirectly assist any Third Party to dispute, the validity of any patent within the AMAG Licensed Patents or any of the claims thereof;

in each case ((a) or (b)) except other than as may be necessary or reasonably required to assert a cross-claim or a counter-claim or to respond to a court request or order or administrative law request or order, and provided that AMAG’s right to terminate this Agreement under this Section 14.2 shall not apply to any Affiliate of Norgine that first becomes an Affiliate of Norgine after the Effective Date of this Agreement in connection with a Business Combination, where such Affiliate of Norgine was undertaking activities described in clauses (a) or (b) above prior to such Business Combination; provided however that Norgine causes such activities to terminate within [***] after such Business Combination. For the avoidance of doubt, an action by Norgine in accordance with Section 12.2 to amend claims within a pending patent application of AMAG during the course of Norgine’s Prosecution of such pending patent application or in defense of a Third Party opposition or other proceeding shall not constitute a challenge under this Section 14.2.

14.3    Termination for Cause. This Agreement may be terminated as a whole, or in part (including on a country-by-country basis), at any time during the Term upon written notice by either Party if the other Party is in material breach of its obligations under this Agreement and, in each case, has not cured such breach within [***] after notice requesting cure of the breach (other than for non-payment which shall be cured within [***]; provided that:

(a)    a breach by Norgine that relates to Norgine’s obligations under this Agreement with respect to one or more specific countries, where such breach does not materially adversely impact the performance by Norgine of its obligations under this Agreement with respect to other countries, shall give AMAG a termination right only as to such affected countries; and

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(b)    if a Party disputes [***] an alleged material breach, and if such Party provides notice to the other Party of such dispute within [***] following such notice provided by the other Party, the other Party [***].

14.4    Termination for Convenience. At any time after the [***] anniversary of the Effective Date, Norgine may terminate this Agreement in its entirety for any or no reason upon [***] written notice to AMAG.

14.5    Termination for Force Majeure. This Agreement may be terminated at any time during the Term upon written notice by either Party in accordance with Section 15.1.

14.6    Effect of Termination.

(a)    If AMAG terminates this Agreement pursuant to Sections 4.8, 14.2, 14.3 (for cause based on material breach by Norgine, including with respect to termination on a country-by-country basis), or 14.5, or if Norgine terminates this Agreement pursuant to Section 14.4, the following will apply (with respect to the terminated countries in the Norgine Territory (in the event of partial termination) and with respect to the entire Norgine Territory (in the event of termination of the Agreement in its entirety)):

(i)    Norgine shall pay any amounts due pursuant to Section 3.2 and Article 6 prior to the date of termination;

(ii)    The licenses and sublicenses granted to Norgine under Section 8.1 shall terminate;

(iii)    At AMAG’s option, the licenses granted to AMAG under Section 8.2 shall survive [***], provided that if AMAG elects survival of such licenses, [***] shall be responsible for [***] costs and expenses owed [***] to a third party pursuant to a license under which Norgine has procured Third Party (x) technology constituting Norgine Licensed Patents or Norgine Licensed Know-How hereunder, or (y) Norgine Controlled Trademarks hereunder;

(iv)    At AMAG’s option with respect to inventory of the Product within the possession or control of Norgine or Norgine’s Sublicensees [***], Norgine shall return to AMAG or its designee and arrange for its Sublicensees to return to AMAG or its designee any quantity of such Product within such that AMAG elects, [***];

(v)    Norgine shall cease to Develop and Commercialize the Product, including immediately stopping enrollment of subjects (unless otherwise directed in writing by AMAG or prohibited by Applicable Laws and Regulations) into any Regulator-Requested Trial being conducted by Norgine and, at AMAG’s sole election either wind-down (including to cease administering the Product to trial subjects, to the extent medically advisable and in accordance with Applicable Laws and Regulations) or transition to AMAG (or its designee), [***] any Regulator-Requested Trial then being conducted by Norgine, but in all cases in a timely manner and in accordance with all Applicable Laws and Regulations;

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(vi)    Norgine shall assign and promptly transfer to AMAG, [***] all of Norgine’s right, title and interest, if any, in and to all Regulatory Submissions, Regulatory Approvals, and drug master files and clinical trial applications, if any (to the extent assignable and not cancelled) specifically for the Product;

(vii)    any Supply Agreements or Ancillary Agreements then in effect shall automatically terminate;

(viii)    all sublicenses under the rights granted by Norgine pursuant to Section 8.1(f) shall terminate, unless converted to a direct license at AMAG’s sole option under Section 8.1(f);

(ix)    AMAG shall revoke (and Norgine shall allow revocation of) any powers of attorney for any AMAG Licensed Patents that Norgine holds as of the time of such termination; and

(x)    only in the event AMAG terminates this Agreement pursuant to Section 14.5, AMAG shall, at its election, [***].

(b)    If Norgine terminates this Agreement pursuant to Sections 4.8, 14.3 (for cause based on material breach by AMAG) or 14.5:

(i)    At AMAG’s option, the licenses granted to AMAG under Section 8.2 shall survive [***] and shall expand to include the Norgine Territory and, at AMAG’s option, to include the Norgine Controlled Trademarks in the Norgine Territory. [***]. Until such matter is finally resolved, Norgine will grant the license on [***] basis [***]. In addition, [***] shall be responsible for its pro-rata share of costs and expenses owed [***] to a third party pursuant to a license under which Norgine has procured Third Party (x) technology constituting Norgine Licensed Patents or Norgine Licensed Know-How hereunder, or (y) Norgine-Controlled     Trademarks hereunder;

(ii)    the provisions of Section 14.6(a) shall apply, except that:

(1)    Norgine and its Affiliates and Sublicensees shall have the right, for a period of [***] after the effective date of termination, to Commercialize and sell all Products within their possession or control, which sales shall be subject to the payment of royalties under Section 6.4, and after such period, Norgine shall return to AMAG or AMAG’s designee any Products remaining within Norgine’s possession or control, [***];

(2)    [***] shall be responsible for all costs and expenses incurred [***] under 14.6(a)(v);

(3)    if directed by Norgine, all sublicenses under the rights granted by Norgine pursuant to Section 8.1(f) shall become direct licensees of AMAG, and Section 14.6(a)(viii) shall not apply;

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(iii)    Norgine shall revoke (and AMAG shall allow revocation of) any powers of attorney for any Norgine Licensed Patents that AMAG holds as of the time of such termination; and

(iv)    AMAG shall, at its election, [***].

(c)    Return of Confidential Information. Upon expiration or termination of this Agreement, the Parties shall comply with Section 9.1(e).

14.7    [***].

14.8    Survival. Termination of this Agreement for any reason will not release either Party of any obligation or liability which, at the time of such termination, has already accrued to the other Party or which is attributable to a period prior to such termination. Notwithstanding anything herein to the contrary, termination of this Agreement by a Party will be without prejudice to other remedies such Party may have at law or equity. The following provisions shall survive the termination or expiration of this Agreement for any reason: Sections 8.1(c) (only upon expiration of the Agreement and not upon earlier termination), 8.2, 8.5, 8.6, 8.7, 12.1, 14.6, 14.8 and 15.3-15.14; Articles 7, 9, 11.

15.    Miscellaneous

15.1    Force Majeure. Neither Party shall be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in performing any obligation under this Agreement (except for any obligations to make payments to the other Party hereunder to the extent not delayed by a Force Majeure event affecting such Party’s banking institutions or payment networks generally) to the extent such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party, including embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, Third-Party lockouts or other labor disturbances that are not directly or indirectly related to or the result of the affected Party’s actions or inactions, fire, floods, epidemics, pandemics, or other acts of God, or acts, omissions or delays in acting by any governmental authority or the other Party (“Force Majeure”). The affected Party shall notify the other Party of such Force Majeure circumstances as soon as reasonably practical, and shall promptly undertake all reasonable efforts necessary to cure or mitigate the effects of such Force Majeure. In the event a Party is unable to perform its obligations under this Agreement due to Force Majeure for a period of [***], and if such inability to perform would constitute a material breach of this Agreement in the absence of such event of Force Majeure, the other Party shall have the option of unilaterally terminating this Agreement upon providing [***] written notice.

15.2    Assignment. Neither Party may assign its rights and obligations under this Agreement without the prior written consent of the other Party, provided that either Party may assign its rights and obligations under this Agreement, without such consent from the other Party, to its Affiliate or any successor in interest in connection with the sale of all or substantially all of its assets or a sale of all or substantially all of the business related to the Product, or a merger, acquisition or other similar transactions. For the avoidance of doubt, the terms and

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conditions of this Agreement shall be binding on the permitted successors and assignees of each Party.

15.3    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 shall 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 shall in such an instance use their 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.

15.4    Notices. All notices which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:

if to AMAG, to:	1100 Winter Street Waltham, MA 02451 Attention: Joseph Vittiglio EVP, Chief Business Officer Facsimile: (617) 499-3361
with copy to: (which shall not constitute notice)	Wilmer Cutler Pickering Hale and Dorr LLP 60 State Street Boston, MA 02109 Attention: Steven D. Singer
if to Norgine, to:	Norgine B.V. Antonio Vivaldistraat 150 1083 HP Amsterdam The Netherlands Attn: Managing Director Facsimile: +31 20 567 09 99
with copy to:	Norgine Limited Norgine House, Widewater Place Moorhall Road Harefield, Middlesex UB9 6NS United Kingdom Attn: Chief Business Development Officer Facsimile: +44 1895 825 865

or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been given upon receipt.

15.5    Governing Law. All questions of inventorship shall be determined in accordance with U.S. patent laws. In respect to all other Patent issues related to the enforceability or validity of a Patent, the laws of the jurisdiction in which the applicable Patent is filed or granted shall govern. Except as otherwise indicated, in all other respects, this Agreement and any Dispute arising from the performance or breach of this Agreement, or the rights and obligations of the

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Parties under this Agreement shall be governed by and construed and enforced in accordance with the laws of the State of New York, United States, without reference to its conflict of laws principles. The United Nations Convention on Contracts for the International Sale of Goods, the 1974 Convention on the Limitation Period in the International Sale of Goods (the “1974 Convention”) and the Protocol amending the 1974 Convention, done at Vienna April 11, 1980, shall not apply to the interpretation of this Agreement.

15.6    Entire Agreement; Amendments. The Agreement contains the entire understanding of the Parties with respect to the subject matter hereof, including the licenses granted hereunder. All express or implied agreements and understandings, either oral or written, with regard to the subject matter hereof, including the licenses granted hereunder, are superseded by the terms of this Agreement, including the Existing CDA. The Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives of both Parties hereto. The “Existing CDA” means that certain Mutual Confidentiality Agreement between the Parties dated as of January 3, 2019. Any confidential information disclosed by the Parties pursuant to the Existing CDA shall be deemed to constitute Confidential Information under this Agreement.

15.7    Headings. The captions to the several Sections and Articles hereof are not a part of the Agreement, but are merely for convenience to assist in locating and reading the several Sections and Articles of this Agreement.

15.8    Independent Contractors. It is expressly agreed that AMAG and Norgine shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither AMAG nor Norgine shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior written consent of the other Party.

15.9    Waiver. The waiver by either Party of any right hereunder, or the failure of the other Party to perform, or a breach by the other Party, shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise.

15.10    Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.

15.11    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 shall be construed against the drafting Party shall not apply.

15.12    Counterparts. The Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Facsimile signatures, scanned signatures, and signatures in PDFs shall be treated as original signatures.

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15.13    Further Assurances. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes, or to better assure and confirm unto such other Party its rights and remedies under this Agreement.

15.14    Construction. Any reference in this Agreement to an Article, Section, subsection, paragraph, clause or Schedule shall be deemed to be a reference to any Article, Section, subsection, paragraph, clause or Schedule, of or to, as the case may be, this Agreement. The captions of this Agreement are for convenience of reference only and in no way define, describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. Except where the context otherwise requires, (a) any definition of or reference to any agreement, instrument or other document refers to such agreement, instrument other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein), (b) any reference to any Applicable Law refers to such Applicable Law including all rules and regulations thereunder and any successor Applicable Law, in each case as from time to time enacted, repealed or amended, (c) the words “herein,” “hereof” and “hereunder,” and words of similar import, refer to this Agreement in its entirety and not to any particular provision hereof, (d) the words “include,” “includes,” and “including” shall be deemed to be followed by the phrase “but not limited to,” “without limitation” or words of similar import, (e) the word “or” is used in the inclusive sense (and/or), (f) words in the singular or plural form include the plural and singular form, respectively, (g) references to any gender refer to each other gender, (h) references to a particular Person include such Person’s successors and assigns to the extent not prohibited by this Agreement, and (i) a capitalized term not defined herein but reflecting a different part of speech than a capitalized term which is defined herein shall be interpreted in a correlative manner.

[Signature Page Follows.]

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The Parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.

AMAG Pharmaceuticals Inc.
By:	/s/ Scott D. Myers
Name:	Scott D. Myers
Title:	President & Chief Executive Officer
Perosphere Pharmaceuticals Inc.
By:	/s/ Joseph Vittiglio
Name:	Joseph Vittiglio
Title:	Corporate Secretary and Executive Vice President

[Signature Page To License And Commercialization Agreement]

ACTIVE/105730326.3

The Parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.

Norgine B.V.
By:	/s/ Peter Stein
Name:	Peter Stein
Title:	Managing Director

ACTIVE/105730326.3

CONFIDENTIAL

Exhibit A

AMAG Licensed Patents

[***]

ACTIVE/105730326.3

CONFIDENTIAL

Exhibit B

Development Plan

[***]

CONFIDENTIAL

Schedule 10.1(e)

AMAG Agreements

[***]

EX-31.1

Exhibit 31.1

CERTIFICATIONS

I, Scott D. Myers, 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:	November 6, 2020
		/s/ Scott D. Myers
		Scott D. Myers
		President and Chief Executive Officer (Principal Executive Officer)

EX-31.2

Exhibit 31.2

CERTIFICATIONS

I, Brian Piekos, 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:	November 6, 2020
		/s/ Brian Piekos
		Brian Piekos
		Executive Vice President, Chief Financial Officer and Treasurer (Principal Financial Officer)

EX-32.1

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 September 30, 2020 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Scott D. Myers, 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/ Scott D. Myers
	Scott D. Myers
	President and Chief Executive Officer
	(Principal Executive Officer)
November 6, 2020

EX-32.2

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 September 30, 2020 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Brian Piekos, Executive Vice President, Chief Financial Officer 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/ Brian Piekos
	Brian Piekos
	Executive Vice President and Chief Financial Officer
	and Treasurer (Principal Financial Officer)
November 6, 2020

XML

Cover Page - shares	9 Months Ended
	Sep. 30, 2020	Nov. 04, 2020
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2020
Document Transition Report	false
Entity File Number	001-10865
Entity Registrant Name	AMAG Pharmaceuticals, Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	04-2742593
Entity Address, Address Line One	1100 Winter Street,
Entity Address, City or Town	Waltham,
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	02451
City Area Code	617
Local Phone Number	498-3300
Title of 12(b) Security	Common Stock, par value $0.01 per share
Trading Symbol	AMAG
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		34,725,063
Entity Central Index Key	0000792977
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2020
Document Fiscal Period Focus	Q3

XML

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Current assets:
Cash and cash equivalents	$ 97,984	$ 113,009
Marketable securities	70,917	58,742
Accounts receivable, net	67,608	94,163
Inventories	22,906	31,553
Prepaid and other current assets	23,959	19,100
Total current assets	283,374	316,567
Property and equipment, net	2,415	4,116
Goodwill	422,513	422,513
Intangible assets, net	1,973	23,620
Operating lease right-of-use asset	21,063	23,286
Deferred tax assets	0	630
Restricted cash	495	495
Other long-term assets	2,523	0
Total assets	734,356	791,227
Current liabilities:
Accounts payable	9,742	27,021
Accrued expenses	146,597	183,382
Current portion of deferred revenue	2,477	0
Current portion of operating lease liability	3,161	4,077
Current portion of acquisition-related contingent consideration	0	17
Total current liabilities	161,977	214,497
Long-term liabilities:
Convertible notes, net	289,334	277,034
Long-term operating lease liability	18,726	19,791
Long-term deferred revenue	7,662	0
Other long-term liabilities	635	89
Total liabilities	478,334	511,411
Commitments and contingencies (Note N)
Stockholders’ equity:
Preferred stock, par value $0.01 per share, 2,000,000 shares authorized; none issued	0	0
Common stock, par value $0.01 per share, 117,500,000 shares authorized; 34,503,435 and 33,999,081 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively	345	339
Additional paid-in capital	1,305,412	1,297,917
Accumulated other comprehensive loss	(3,068)	(3,239)
Accumulated deficit	(1,046,667)	(1,015,201)
Total stockholders’ equity	256,022	279,816
Total liabilities and stockholders’ equity	$ 734,356	$ 791,227

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CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2020	Dec. 31, 2019
Statement of Financial Position [Abstract]
Preferred stock, par value (in dollars per share)	$ 0.01	$ 0.01
Preferred stock, shares authorized (in shares)	2,000,000	2,000,000
Preferred stock, shares issued (in shares)	0	0
Common stock, par value (in dollars per share)	$ 0.01	$ 0.01
Common stock, shares authorized (in shares)	117,500,000	117,500,000
Common stock, shares issued (in shares)	34,503,435	33,999,081
Common stock, shares outstanding (in shares)	34,503,435	33,999,081

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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Revenues:
Revenues	$ 93,106	$ 83,808	$ 210,637	$ 237,062
Costs and expenses:
Cost of product sales	$ 13,340	$ 21,105	$ 55,426	$ 63,871
Cost, Product and Service [Extensible List]	us-gaap:ProductMember	us-gaap:ProductMember	us-gaap:ProductMember	us-gaap:ProductMember
Research and development expenses	$ 7,115	$ 15,330	$ 26,558	$ 48,377
Acquired in-process research and development	0	0	0	74,856
Selling, general and administrative expenses	35,656	65,720	127,922	217,727
Impairment of intangible assets	0	0	0	77,358
Loss on disposal of assets, net	35,400	0	20,956	0
Restructuring expenses	0	0	8,197	7,420
Total costs and expenses	91,511	102,155	239,059	489,609
Operating income (loss)	1,595	(18,347)	(28,422)	(252,547)
Other income (expense):
Interest expense	(6,798)	(6,419)	(20,101)	(19,199)
Interest and dividend income	246	840	1,050	3,650
Other income	14,606	218	15,894	561
Total other income (expense), net	8,054	(5,361)	(3,157)	(14,988)
Income (loss) before income taxes	9,649	(23,708)	(31,579)	(267,535)
Income tax (benefit) expense	(53)	232	(113)	(26)
Net income (loss)	$ 9,702	$ (23,940)	$ (31,466)	$ (267,509)
Net income (loss) per share:
Basic (in dollars per share)	$ 0.28	$ (0.71)	$ (0.92)	$ (7.85)
Diluted (in dollars per share)	$ 0.28	$ (0.71)	$ (0.92)	$ (7.85)
Weighted average shares outstanding used to compute net income (loss) per share:
Basic (in shares)	34,484	33,906	34,314	34,058
Diluted (in shares)	34,720	33,906	34,314	34,058
Product Sales
Revenues:
Revenues	$ 73,229	$ 83,784	$ 190,702	$ 236,831
Collaboration revenue
Revenues:
Revenues	19,838	0	19,838	0
Other revenues
Revenues:
Revenues	$ 39	$ 24	$ 97	$ 231

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CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Statement of Comprehensive Income [Abstract]
Net income (loss)	$ 9,702	$ (23,940)	$ (31,466)	$ (267,509)
Other comprehensive loss:
Unrealized (losses) gains on securities, net of tax	(104)	(167)	171	786
Total comprehensive income (loss)	$ 9,598	$ (24,107)	$ (31,295)	$ (266,723)

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CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands	Total	Common Stock	Additional Paid-in Capital	Accumulated Other Comprehensive Loss	Accumulated Deficit
Beginning balance (in shares) at Dec. 31, 2018		34,606,760
Beginning balance at Dec. 31, 2018	$ 741,557	$ 346	$ 1,292,736	$ (3,985)	$ (547,540)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings (in shares)		278,474
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings	(1,787)	$ 3	(1,790)
Issuance of common stock under employee stock purchase plan (in shares)		105,075
Issuance of common stock under employee stock purchase plan	851	$ 1	850
Repurchase of common stock pursuant to the share repurchase program (in shares)		(1,074,800)
Repurchase of common stock pursuant to the share repurchase program	(13,730)	$ (11)	(13,719)
Non-cash equity based compensation	14,381		14,381
Unrealized (losses) gains on securities, net of tax	786			786
Net income (loss)	(267,509)				(267,509)
Ending balance (in shares) at Sep. 30, 2019		33,915,509
Ending balance at Sep. 30, 2019	474,549	$ 339	1,292,458	(3,199)	(815,049)
Beginning balance (in shares) at Jun. 30, 2019		33,899,954
Beginning balance at Jun. 30, 2019	493,751	$ 339	1,287,553	(3,032)	(791,109)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings (in shares)		15,555
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings	(69)		(69)
Non-cash equity based compensation	4,974		4,974
Unrealized (losses) gains on securities, net of tax	(167)			(167)
Net income (loss)	(23,940)				(23,940)
Ending balance (in shares) at Sep. 30, 2019		33,915,509
Ending balance at Sep. 30, 2019	$ 474,549	$ 339	1,292,458	(3,199)	(815,049)
Beginning balance (in shares) at Dec. 31, 2019	33,999,081	33,999,081
Beginning balance at Dec. 31, 2019	$ 279,816	$ 339	1,297,917	(3,239)	(1,015,201)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings (in shares)		408,152
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings	(1,232)	$ 5	(1,237)
Issuance of common stock under employee stock purchase plan (in shares)		96,202
Issuance of common stock under employee stock purchase plan	631	$ 1	630
Non-cash equity based compensation	8,102		8,102
Unrealized (losses) gains on securities, net of tax	171			171
Net income (loss)	$ (31,466)				(31,466)
Ending balance (in shares) at Sep. 30, 2020	34,503,435	34,503,435
Ending balance at Sep. 30, 2020	$ 256,022	$ 345	1,305,412	(3,068)	(1,046,667)
Beginning balance (in shares) at Jun. 30, 2020		34,463,373
Beginning balance at Jun. 30, 2020	244,106	$ 344	1,303,095	(2,964)	(1,056,369)
Increase (Decrease) in Stockholders' Equity [Roll Forward]
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings (in shares)		40,062
Net shares issued in connection with the exercise of stock options and vesting of restricted stock units, net of withholdings	95	$ 1	94
Non-cash equity based compensation	2,223		2,223
Unrealized (losses) gains on securities, net of tax	(104)			(104)
Net income (loss)	$ 9,702				9,702
Ending balance (in shares) at Sep. 30, 2020	34,503,435	34,503,435
Ending balance at Sep. 30, 2020	$ 256,022	$ 345	$ 1,305,412	$ (3,068)	$ (1,046,667)

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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Cash flows from operating activities:
Net loss	$ (31,466)	$ (267,509)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	22,276	13,871
Impairment of intangible assets	0	77,358
Provision for bad debt expense	230	(12)
Amortization of premium/discount on purchased securities	94	(64)
Write-down of inventory	1,916	4,872
Loss on disposal of property & equipment	273	0
Non-cash equity-based compensation expense	8,100	14,381
Non-cash IPR&D expense	0	18,029
Amortization of debt discount and debt issuance costs	12,300	11,332
Gains on marketable securities, net	(10)	(263)
Change in fair value of contingent consideration	0	(16)
Deferred income taxes	630	408
Non-cash lease expense	1,416	0
Gain on sale of assets	7,047	0
Changes in operating assets and liabilities:
Accounts receivable, net	26,328	(2,229)
Inventories	(676)	(6,824)
Prepaid and other current assets	(5,797)	(24,075)
Accounts payable and accrued expenses	(58,258)	54,073
Deferred revenues	9,461	(101)
Other assets and liabilities	(627)	1,038
Net cash used in operating activities	(6,763)	(105,731)
Cash flows from investing activities:
Proceeds from sales or maturities of marketable securities	43,675	85,321
Purchase of marketable securities	(55,763)	(14,815)
Milestone payment for Vyleesi developed technology	0	(60,000)
Net proceeds from the sale of assets	4,920	0
Capital expenditures	(475)	(2,098)
Net cash (used in) provided by investing activities	(7,643)	8,408
Cash flows from financing activities:
Payments to settle convertible notes	0	(21,417)
Payments of contingent consideration	(17)	(50)
Payments for repurchases of common stock	0	(13,730)
Proceeds from the issuance of common stock under the ESPP	630	851
Proceeds from the exercise of common stock options	168	30
Payments of employee tax withholding related to equity-based compensation	(1,400)	(1,817)
Net cash used in financing activities	(619)	(36,133)
Net decrease in cash, cash equivalents, and restricted cash	(15,025)	(133,456)
Cash, cash equivalents, and restricted cash at beginning of the period	113,504	253,751
Cash, cash equivalents, and restricted cash at end of the period	98,479	120,295
Supplemental data for cash flow information:
Cash (refunded) paid for taxes	(254)	456
Cash paid for interest	5,200	5,467
Non-cash investing and financing activities:
Settlement of note receivable in connection with Perosphere acquisition	0	10,000
Right-of-use assets obtained in exchange for lease liabilities	$ 0	$ 918

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Description of Business

9 Months Ended

Sep. 30, 2020

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Description of Business

DESCRIPTION OF BUSINESS

AMAG Pharmaceuticals, Inc., a Delaware corporation, was founded in 1981. Throughout this Quarterly Report on Form 10-Q, AMAG Pharmaceuticals, Inc. and our consolidated subsidiaries are collectively referred to as “the Company,” “AMAG,” “we,” “us,” or “our.” We are a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs by leveraging our development and commercial expertise to invest in and grow our pharmaceutical products and product candidates across a range of therapeutic areas. As of September 30, 2020, we marketed products that support the health of patients in the areas of hematology and maternal health, including Feraheme® (ferumoxytol injection) for intravenous use and Makena® (hydroxyprogesterone caproate injection) auto-injector. In addition to our approved products, our portfolio includes ciraparantag, a product candidate that is being studied as an anticoagulant reversal agent.

In December 2019, we completed a review of our product portfolio and strategy. This strategic review resulted in our intention to divest our women’s health assets, as announced in January 2020, and as previously disclosed, we completed the divestiture of Intrarosa® (prasterone) during the second quarter of 2020. We completed the divestiture of our remaining women’s health asset, Vyleesi® (bremelanotide injection), in July 2020, which we determined did not meet the criteria for presentation as a discontinued operation, as it did not represent a strategic shift to our business as described above. For additional details on our divestiture of Vyleesi, refer to Note O, “Acquisitions, Collaboration, License and other Strategic Agreements”.

In July 2020, we also decided to stop the AMAG-423 Phase 2b/3a study based, primarily, on the results of an interim analysis conducted by the study’s independent Data Safety Monitoring Board (“DSMB”). For additional details on our decision to stop the AMAG 423 study, refer to Note O, “Acquisitions, Collaboration, License and other Strategic Agreements”.

On October 1, 2020, we entered into an Agreement and Plan of Merger with Covis Group S.à r.l., a Luxembourg company (“Covis”), Covis Mergerco Inc., a Delaware corporation and an indirect wholly owned subsidiary of Covis (“Merger Sub”), and (in respect of specific matters) Covis Finco S.à r.l., a Luxembourg company (the “Merger Agreement”), pursuant to which Merger Sub launched a cash tender offer (the “Offer”) to acquire all of the issued and outstanding shares of common stock of AMAG at a price per share of $13.75, net to the seller in cash, without interest. The Offer commenced on October 15, 2020 and will remain open for a minimum of 20 business days. The completion of the Offer is subject to customary closing conditions. For additional information, see Note T, “Subsequent Events”.

On October 5, 2020, we received notice of the FDA’s Center for Drug Evaluation and Research proposal to withdraw marketing approval of Makena and notice of our opportunity to request a hearing. For additional information, refer to Note T, “Subsequent Events”.

COVID-19

The global spread of COVID-19 has created significant volatility, uncertainty and economic disruption on a global scale, including in the United States, where we market our products, where our operations and employees reside and where we conduct clinical trials. The COVID-19 pandemic did not significantly impact our financial results during the three months ended September 30, 2020. The extent to which the COVID-19 pandemic impacts our business, operations and financial results in the future will depend on numerous evolving factors that we may not be able to accurately predict. While there have been no material impairments to date, any prolonged material disruptions to our sales, supply, research and development efforts and/or operations could negatively impact the Company’s business, operations and/or financial results.

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Basis of Presentation and Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2020

Accounting Policies [Abstract]

Basis of Presentation and Summary of Significant Accounting Policies

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 our financial position and results of operations 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 (“GAAP”).

In accordance with GAAP 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 Consolidated Financial Statements in our

Annual Report on Form 10-K for the year ended December 31, 2019, as amended (our “Annual Report”). 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.

Principles of Consolidation

The accompanying condensed consolidated financial statements include our accounts and the accounts of our wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.

Use of Estimates and Assumptions

The preparation of our condensed consolidated financial statements in conformity with GAAP requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent liabilities. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity and the amount of revenues and expenses. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including product sales revenue; product sales allowances and accruals; allowance for expected credit losses; marketable securities; inventory; fair value estimates used to assess impairment of long-lived assets, including goodwill and other intangible assets; debt obligations; certain accrued liabilities, including clinical trial accruals; equity-based compensation expense; and income taxes, inclusive of valuation allowances, will depend on future developments that are highly uncertain, including new information that may emerge concerning COVID-19 and the actions taken to contain or treat its impact, as well as the economic impact on local, regional and national customers and markets. We have made estimates of the impact of COVID-19 within our financial statements and there may be changes to those estimates in future periods. Actual results could differ materially from these estimates.

Concentrations and Significant Customer Information

Financial instruments which potentially subject us to concentrations of credit risk consist principally of cash and cash equivalents, marketable securities, and accounts receivable. As of September 30, 2020, we held our excess cash primarily in institutional money market funds, corporate debt securities, commercial paper, U.S. treasury and government agency securities and certificates of deposit. As of September 30, 2020, we did not have a material concentration in any single investment.

Our operations are located entirely within the U.S. We focus primarily on developing, manufacturing, and commercializing our products and product candidates. The following table sets forth customers who represented 10% or more of our total revenues for the three and nine months ended September 30, 2020 and 2019:

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
McKesson Corporation	36	%	38	%	36	%	37	%
AmerisourceBergen Drug Corporation	32	%	28	%	33	%	27	%
Cardinal Health	12	%	11	%	11	%	12	%

Our net accounts receivable primarily represent amounts due for products sold directly to wholesalers, distributors and specialty pharmacies. Accounts receivable for our products are recorded net of reserves for estimated chargeback obligations, prompt payment discounts and any allowance for expected credit losses. At September 30, 2020, two customers accounted for 10% or more of our accounts receivable balances, representing approximately 76% in the aggregate of our total accounts receivable. At December 31, 2019, three customers accounted for 10% or more of our accounts receivable balances, representing approximately 85% in the aggregate of our total accounts receivable.

We are currently dependent on a single supplier for certain of our manufacturing processes, including for Feraheme drug substance (produced in two separate facilities) and for our Makena auto-injector product. We have been and may continue to be exposed to a significant loss of revenue from the sale of our products in the event that our suppliers and/or manufacturers are not able to fulfill demand for any reason.

Recently Adopted Accounting Pronouncements

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“Topic 326”). We adopted Topic 326 effective January 1, 2020 using a modified retrospective approach. The adoption of Topic 326 did not have a material impact on our condensed consolidated financial statements and accordingly, no transition adjustment was recorded at the adoption date. Under Topic 326, we estimate expected credit losses for our trade receivables held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. We also evaluate any impaired marketable securities against the new impairment model within Topic 326 to determine whether any loss or allowance for credit loss should be recorded at the reporting date.

In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”) as part of its Simplification Initiative to reduce the cost and complexity in accounting for income taxes. ASU 2019-12 removes certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. ASU 2019-12 also amends other aspects of the guidance to help simplify and promote consistent application of GAAP. The guidance is effective for interim and annual periods beginning after December 15, 2020, with early adoption permitted. We adopted ASU 2019-12 effective January 1, 2020. The adoption of ASU 2019-12 did not have a material impact on our condensed consolidated financial statements.

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Revenue Recognition

9 Months Ended

Sep. 30, 2020

Revenue from Contract with Customer [Abstract]

Revenue Recognition

REVENUE RECOGNITION

Product Revenue and Allowances and Accruals

The following table provides information about disaggregated revenue by product for the three and nine months ended September 30, 2020 and 2019 (in thousands):

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Product sales, net
Feraheme	$	46,718	$	44,205	$	120,786	$	126,294
Makena	25,860		33,949		66,079		95,483
Intrarosa	37		5,607		4,423		14,898
Other	614		23		(586)		156
Total product sales, net	$	73,229	$	83,784	$	190,702	$	236,831

Total gross product sales were offset by product sales allowances and accruals for the three and nine months ended September 30, 2020 and 2019 as follows (in thousands):

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Gross product sales	$	218,739	$	254,073	$	633,475	$	704,976
Provision for product sales allowances and accruals:
Contractual adjustments	129,966		144,108		383,003		381,633
Governmental rebates	15,544		26,181		59,770		86,512
Total	145,510		170,289		442,773		468,145
Product sales, net	$	73,229	$	83,784	$	190,702	$	236,831

The following table summarizes the product revenue allowance and accrual activity for the three and nine months ended September 30, 2020 (in thousands):

	Contractual		Governmental
	Adjustments		Rebates		Total
Balance at December 31, 2019	$	95,221	$	47,623	$	142,844
Provisions related to current period sales	147,235		20,982		168,217
Adjustments related to prior period sales	(4,060)		976		(3,084)
Payments/returns relating to current period sales	(95,284)		—		(95,284)
Payments/returns relating to prior period sales	(37,969)		(29,646)		(67,615)
Balance at March 31, 2020	$	105,143	$	39,935	$	145,078
Provisions related to current period sales	111,508		21,904		133,412
Adjustments related to prior period sales	(634)		378		(256)
Payments/returns relating to current period sales	(112,821)		(13,913)		(126,734)
Payments/returns relating to prior period sales	(19,484)		(10,240)		(29,724)
Balance at June 30, 2020	$	83,712	$	38,064	$	121,776
Provisions related to current period sales	129,402		17,410		146,812
Adjustments related to prior period sales	565		(1,867)		(1,302)
Payments/returns relating to current period sales	(115,634)		(14,259)		(129,893)
Payments/returns relating to prior period sales	(5,803)		(830)		(6,633)
Balance at September 30, 2020	$	92,242	$	38,518	$	130,760

Collaboration Revenue

In July 2020, we entered into a License and Commercialization Agreement with Norgine B.V. (“Norgine”, and such agreement, the “Norgine Agreement”), pursuant to which we granted Norgine an exclusive license to develop and commercialize ciraparantag in certain countries in Europe, Australia and New Zealand (the “Norgine Territory”). We received a $30.0 million upfront payment upon signing. In addition, pursuant to the terms and conditions of the Norgine Agreement (a) Norgine will pay us one-third of the actual and reasonable out-of-pocket costs of the Phase 3 program, pursuant to a mutually agreed upon budget, (b) we are eligible to receive up to $70.0 million upon the achievement of certain regulatory milestones (of which we will pay $40.0 million to the former equity holders of Perosphere pursuant to the terms of the Perosphere Agreement (described below), (c) we are eligible to receive up to $190.0 million contingent upon meeting certain sales milestones, and (d) Norgine will pay us tiered double-digit royalties on net sales in the licensed territory. Norgine will be responsible for the regulatory filings and any clinical trials specifically required for approval of the Product in the Norgine Territory and will hold all marketing authorizations in the Norgine Territory. We will be responsible for manufacturing and supplying Norgine with its requirements of clinical and commercial product pursuant to supply agreement(s) to be entered into by the parties.

In accordance with ASC 808, we considered the nature and contractual terms of the arrangement and the nature of our business operations to determine the classification of payments under the Norgine Agreement and concluded that Norgine meets the definition of a customer. As a result, the Norgine Agreement was accounted for under ASC 606. We determined that the Norgine Agreement contains three distinct performance obligations: (i) delivery of a license granting rights to clinical data developed to date and rights to develop and commercialize ciraparantag in the Norgine Territory (the “License”), (ii) research and development services, and (iii) participation on the joint development and steering committees.

We allocated the upfront consideration to each performance obligation using the standalone selling prices based on our estimate of selling price for the License, research and development services and participation on the joint development and steering committees. To determine the standalone selling price for the License and for the participation on the joint development and joint steering committees, we used an adjusted market approach. For the License, the adjusted market approach included an assessment of the likelihood of achievement of certain regulatory milestones using third party evidence and the likelihood of regulatory approval of ciraparantag and the expected future cash flows assuming regulatory approval in the Norgine Territory, discounting these cash flows using a risk adjusted discount rate of approximately 27%. For the research and development services we determined the standalone selling pricing using a cost plus margin approach. For the joint development and joint steering committees, the adjusted market approach included an assessment of consulting rates prevalent in the marketplace.

Under Topic 606, we allocated the $30.0 million upfront payment as follows: $19.8 million to the License and $10.2 million to the research and development services. No consideration was allocated to the performance obligation related to participation on the joint development and steering committees, as its standalone selling price was not material. The amounts allocated to the licenses were recognized upon delivery of the licenses during the three months ended September 30, 2020. The amount allocated to the development services will be recognized over the course of the development work using an input method in the form of development effort relative to expected total development effort at the completion of the development services. This is based on the relative costs of the development activities incurred and expected to be incurred in the future to satisfy the performance obligation. The estimated period of performance to satisfy the performance obligation and project cost will be reviewed periodically and adjusted, as needed, to reflect our current expectations regarding the costs and timing of the deliverable. These estimates are subject to a number of assumptions and actual results could differ materially from our assumptions in future periods.

We determined that the future regulatory and sales-based milestone and sales-based royalty payments that we may be entitled to receive are variable consideration. We are using a most likely amount method for estimating the variable consideration to be received related to regulatory milestones under this arrangement. All future potential regulatory milestones were fully constrained at September 30, 2020. The sales-based milestones and royalties are subject to the sales-and-usage-based royalty exception related to a license of intellectual property and will be recorded in the period when the corresponding sale occurs.

As of September 30, 2020, deferred revenue related to the development services performance obligation amounted to $10.2 million, of which $2.5 million was included in current liabilities.

In addition, the Company incurred approximately $2.0 million of contract acquisition costs related to the Norgine Agreement. These costs are expensed as selling, general and administrative expense based on the transfer of control of the underlying performance obligations, as determined on a relative standalone selling price basis. As of September 30, 2020, the Company recorded approximately $1.3 million in selling, general and administrative expense and deferred $0.7 million as a component of other long-term assets.

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Marketable Securities

9 Months Ended

Sep. 30, 2020

Investments, Debt and Equity Securities [Abstract]

Marketable Securities

MARKETABLE SECURITIESAs of September 30, 2020 and December 31, 2019, our marketable securities 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 marketable securities.

The following is a summary of our marketable securities as of September 30, 2020 and December 31, 2019 (in thousands):

	September 30, 2020
			Gross		Gross		Estimated
	Amortized		Unrealized		Unrealized		Fair
	Cost		Gains		Losses		Value
Securities maturing within one year:
Corporate debt securities	$	23,861	$	145	$	(1)	$	24,005
Certificates of deposit	14,300		—		—		14,300
Commercial paper	9,488		—		—		9,488
Total securities maturing within one year	$	47,649	$	145	$	(1)	$	47,793
Securities maturing between one and three years:
Corporate debt securities	$	16,809	$	319	$	(2)	$	17,126
U.S. treasury and government agency securities	4,998		—		—		4,998
Certificates of deposit	1,000		—		—		1,000
Total securities maturing between one and three years	$	22,807	$	319	$	(2)	$	23,124
Total marketable securities	$	70,456	$	464	$	(3)	$	70,917

	December 31, 2019
			Gross		Gross		Estimated
	Amortized		Unrealized		Unrealized		Fair
	Cost		Gains		Losses		Value
Securities maturing within one year:
Corporate debt securities	$	46,186	$	140	$	(2)	$	46,324
U.S. treasury and government agency securities	2,750		—		—		2,750
Certificates of deposit	1,500		—		—		1,500
Total securities maturing within one year	$	50,436	$	140	$	(2)	$	50,574
Securities maturing between one and three years:
Corporate debt securities	$	8,016	$	152	$	—	$	8,168
Total securities maturing between one and three years	8,016		152		—		8,168
Total marketable securities	$	58,452	$	292	$	(2)	$	58,742

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Fair Value Measurements

9 Months Ended

Sep. 30, 2020

Fair Value Disclosures [Abstract]

Fair Value Measurements

FAIR VALUE MEASUREMENTS

The following tables present information about our assets and liabilities that we measure at fair value on a recurring basis and indicate the level within the fair value hierarchy of the valuation techniques utilized to determine such fair value as of September 30, 2020 and December 31, 2019 (in thousands):

	Fair Value Measurements at September 30, 2020 Using:
			Quoted Prices in				Significant
			Active Markets for		Significant Other		Unobservable
			Identical Assets		Observable Inputs		Inputs
	Total		(Level 1)		(Level 2)		(Level 3)
Assets:
Cash equivalents	$	2,750	$	2,750	$	—	$	—
Corporate debt securities	41,131		—		41,131		—
U.S. treasury and government agency securities	4,998				4,998		—
Certificates of deposit	15,300		—		15,300		—
Commercial paper	9,488				9,488		—
Total assets	$	73,667	$	2,750	$	70,917	$	—

	Fair Value Measurements at December 31, 2019 Using:
			Quoted Prices in				Significant
			Active Markets for		Significant Other		Unobservable
			Identical Assets		Observable Inputs		Inputs
	Total		(Level 1)		(Level 2)		(Level 3)
Assets:
Cash equivalents	$	13,732	$	13,732	$	—	$	—
Corporate debt securities	54,492		—		54,492		—
U.S. treasury and government agency securities	2,750		—		2,750		—
Certificates of deposit	1,500		—		1,500		—
Total assets	$	72,474	$	13,732	$	58,742	$	—
Liabilities:
Contingent consideration - MuGard	$	17	$	—	$	—	$	17
Total liabilities	$	17	$	—	$	—	$	17

Cash Equivalents

Our cash equivalents are classified as Level 1 assets under the fair value hierarchy as these assets have been valued using quoted market prices in active markets and do not have any restrictions on redemption. As of September 30, 2020 and December 31, 2019, cash equivalents were primarily comprised of funds in money market accounts.

Marketable Securities

Our marketable securities are classified as Level 2 assets under the fair value hierarchy as the values of these assets are primarily determined from independent pricing services, which 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 a quantitative and qualitative analysis of prices received from third parties to determine whether prices are reasonable estimates of fair value. After completing our analysis, we did not adjust or override any fair value measurements provided by our pricing services as of September 30, 2020. In addition, there were no transfers or reclassifications of any securities between Level 1 and Level 2 during the nine months ended September 30, 2020.

Debt

We estimate the fair value of our debt obligations using quoted market prices obtained from third-party pricing services, which are classified as Level 2 inputs. As of September 30, 2020, the estimated fair value of our 2022 Convertible Notes (as defined in Note P, “Debt” below) was $289.7 million, which differed from its carrying value. See Note P, “Debt” for additional information on our debt obligations.

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Inventories

9 Months Ended

Sep. 30, 2020

Inventory Disclosure [Abstract]

Inventories

INVENTORIES

Our major classes of inventories were as follows as of September 30, 2020 and December 31, 2019 (in thousands):

	September 30, 2020		December 31, 2019
Raw materials	$	3,424	$	5,211
Work in process	6,495		6,248
Finished goods	12,987		20,094
Total inventories	$	22,906	$	31,553

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Property and Equipment, Net

9 Months Ended

Sep. 30, 2020

Property, Plant and Equipment [Abstract]

Property and Equipment, Net

PROPERTY AND EQUIPMENT, NET

Property and equipment, net consisted of the following as of September 30, 2020 and December 31, 2019 (in thousands):

	September 30, 2020		December 31, 2019
Computer equipment and software	$	1,568	$	1,568
Furniture and fixtures	1,714		1,714
Leasehold improvements	4,985		4,984
Laboratory and production equipment	6,281		6,570
Construction in progress	361		656
	14,909		15,492
Less: accumulated depreciation	(12,494)		(11,376)
Property and equipment, net	$	2,415	$	4,116

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Goodwill and Intangible Assets, Net

9 Months Ended

Sep. 30, 2020

Goodwill and Intangible Assets Disclosure [Abstract]

Goodwill and Intangible Assets, Net

GOODWILL AND INTANGIBLE ASSETS, NET

Goodwill

As of September 30, 2020, we had no accumulated impairment losses related to goodwill.

Intangible Assets

As of September 30, 2020 and December 31, 2019, our intangible assets consisted of the following (in thousands):

	September 30, 2020								December 31, 2019
			Accumulated		Cumulative						Accumulated		Cumulative
	Cost		Amortization		Impairments		Net		Cost		Amortization		Impairments		Net
Amortizable intangible assets:
Makena auto-injector developed technology	$	79,100	$	21,701	$	55,426	$	1,973	$	79,100	$	15,782	$	55,426	$	7,892
Intrarosa developed technology	—		—		—		—		77,655		16,798		56,881		3,976
Vyleesi developed technology	—		—		—		—		60,000		9,264		38,984		11,752
Total intangible assets	$	79,100	$	21,701	$	55,426	$	1,973	$	216,755	$	41,844	$	151,291	$	23,620

In May 2020, we sold all of our rights to Intrarosa and accordingly, wrote off the related developed technology intangible asset. In July 2020, we completed the divestiture of Vyleesi and accordingly, wrote off the related developed technology intangible asset, which was fully amortized as of June 30, 2020.

As of September 30, 2020, the weighted average remaining amortization period for our finite-lived intangible assets was less than one year. Total amortization expense for the nine months ended September 30, 2020 and 2019 was $20.8 million and $12.1 million, respectively. Amortization expense is recorded in cost of product sales on our condensed consolidated statements of operations. We expect our finite-lived intangible assets to be fully amortized in 2020.

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Current Liabilities

9 Months Ended

Sep. 30, 2020

Payables and Accruals [Abstract]

Current Liabilities

CURRENT LIABILITIES

Accrued expenses consisted of the following as of September 30, 2020 and December 31, 2019 (in thousands):

	September 30, 2020		December 31, 2019
Commercial rebates, fees and returns	$	106,367	$	124,730
Manufacturing costs	8,778		21,364
Salaries, bonuses, and other compensation	13,121		18,693
Professional, license, and other fees and expenses	12,403		13,392
Research and development expense	865		3,539
Interest expense	3,467		867
Restructuring expense	1,596		797
Total accrued expenses	$	146,597	$	183,382

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Income Taxes

9 Months Ended

Sep. 30, 2020

Income Tax Disclosure [Abstract]

Income Taxes

INCOME TAXES

The following table summarizes our effective tax rate and income tax (benefit) expense for the three and nine months ended September 30, 2020 and 2019 (in thousands except for percentages):

	Three Months Ended September 30,						Nine Months Ended September 30,
	2020			2019			2020			2019
Effective tax rate	(1)		%	(1)		%	—		%	—		%
Income tax (benefit) expense	$	(53)		$	232		$	(113)		$	(26)

For the three and nine months ended September 30, 2020, we recognized an immaterial income tax benefit, representing an effective tax rate of (1)% and 0%, respectively. The difference between the statutory federal tax rate of 21% and the effective tax rates for the three and nine months ended September 30, 2020, was primarily attributable to the valuation allowance established against our current period losses generated. We have established a valuation allowance on our deferred tax assets to the extent that our existing taxable temporary differences would not be available as a source of income to realize the benefits of those deferred tax assets. The income tax benefit for the three and nine months ended September 30, 2020 primarily related to state income taxes.

On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act was signed into law making several changes to the Internal Revenue Code. The changes include, but are not limited to, temporarily increasing the limitation on the amount of deductible interest expense, allowing taxpayers with alternative minimum tax credits to claim a refund for the entire amount of the credit instead of recovering the credit through refunds over a period of years, as required by the 2017 Tax Cuts and Jobs Act, allowing companies to carryback certain net operating losses, and temporarily increasing the amount of net operating loss carryforwards that corporations can use to offset taxable income. The tax law changes in the CARES Act did not have a material impact on our income tax provision.

For the three and nine months ended September 30, 2019, we recognized an immaterial income tax expense and an immaterial income tax benefit, representing an effective tax rate of (1)% and 0%, respectively. The income tax expense for the three months ended September 30, 2019 primarily related to state income taxes. The income tax benefit for the nine months ended September 30, 2019 primarily related to the offset of the recognition of the income tax expense recorded in other comprehensive loss associated with the increase in the fair value of the available-for-sale debt securities that we carried at fair market value during the period, partially offset by state income taxes. The difference between the statutory federal tax rate of 21% and the effective tax rate of (1)% and 0% for the three and nine months ended September 30, 2019, respectively, was primarily attributable to the valuation allowance established against our current period losses generated and the non-deductible IPR&D expense related to the Perosphere acquisition.

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Earnings Per Share

9 Months Ended

Sep. 30, 2020

Earnings Per Share [Abstract]

Earnings Per Share

EARNINGS PER SHARE The components of basic and diluted earnings per share for the three and nine months ended September 30, 2020 and 2019 were as follows (in thousands, except per share data):

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Net income (loss) - basic and diluted	$	9,702	$	(23,940)	$	(31,466)	$	(267,509)
Weighted average common shares outstanding	34,484		33,906		34,314		34,058
Effect of dilutive securities:
Stock options and RSUs	236		—		—		—
Shares used in calculating dilutive net income (loss) per share	34,720		33,906		34,314		34,058
Net income (loss) per share:
Basic	$	0.28	$	(0.71)	$	(0.92)	$	(7.85)
Diluted	$	0.28	$	(0.71)	$	(0.92)	$	(7.85)

The following table sets forth the potential common shares issuable upon the exercise of outstanding options, the vesting of restricted stock units (“RSUs”), and the conversion of the 2022 Convertible Notes, which were excluded from our computation of diluted net income (loss) per share because their inclusion would have been anti-dilutive (in thousands):

	Nine Months Ended September 30,
	2020	2019
Options to purchase shares of common stock	4,233	3,988
Shares of common stock issuable upon the vesting of RSUs	1,035	1,645
2022 Convertible Notes	11,695	11,695
Total	16,963	17,328

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Equity-Based Compensation

9 Months Ended

Sep. 30, 2020

Share-based Payment Arrangement [Abstract]

Equity-Based Compensation

EQUITY-BASED COMPENSATION

We currently maintain three equity compensation plans; our 2019 Equity Incentive Plan (the “2019 Plan”), which was approved by our stockholders at our 2019 annual meeting and replaced our Fourth Amended and Restated 2007 Equity Incentive Plan (the “2007 Plan”), the Lumara Health Inc. Amended and Restated 2013 Incentive Compensation Plan (the “Lumara Health 2013 Plan”) and our 2015 Employee Stock Purchase Plan (“2015 ESPP”). All outstanding stock options granted under each of our equity compensation plans other than our 2015 ESPP have an exercise price equal to the closing price of a share of our common stock on the grant date.

During 2020, we also granted equity through inducement grants outside of our equity compensation plans to certain employees to induce them to accept employment with us (collectively, “Inducement Grants”). The options were granted at an exercise price equal to the fair market value of a share of our common stock on the respective grant dates and will become exercisable in four equal annual installments beginning on the first anniversary of the respective grant dates. The foregoing grants were made pursuant to inducement grants outside of our stockholder approved equity plans as permitted under the NASDAQ Stock Market listing 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.

Stock Options

The following table summarizes stock option activity for the nine months ended September 30, 2020:

	2019	2007	Lumara Health	Inducement
	Plan	Plan	2013 Plan	Grants	Total
Outstanding at January 1, 2020	472,412	2,585,466	131,775	696,164	3,885,817
Granted	420,912	—	—	1,000,000	1,420,912
Exercised	(18,487)	—	(1,450)	—	(19,937)
Expired or terminated	(149,863)	(672,295)	(43,250)	(188,098)	(1,053,506)
Outstanding at September 30, 2020	724,974	1,913,171	87,075	1,508,066	4,233,286

Restricted Stock Units

The following table summarizes RSU activity for the nine months ended September 30, 2020:

	2019	2007	Lumara Health	Inducement
	Plan	Plan	2013 Plan	Grants	Total
Outstanding at January 1, 2020	128,742	1,407,305	2,167	41,223	1,579,437
Granted	825,131	—	—	—	825,131
Vested	(78,689)	(460,185)	(899)	(10,862)	(550,635)
Expired or terminated	(209,697)	(591,972)	(534)	(17,169)	(819,372)
Outstanding at September 30, 2020	665,487	355,148	734	13,192	1,034,561

Equity-Based Compensation Expense

Equity-based compensation expense for the three and nine months ended September 30, 2020 and 2019 consisted of the following (in thousands):

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Cost of product sales	$	131	$	225	$	438	$	626
Research and development	237		691		260		2,051
Selling, general and administrative	1,854		4,058		7,403		11,039
Total equity-based compensation expense	2,222		4,974		8,101		13,716
Income tax effect	—		—		—		—
After-tax effect of equity-based compensation expense	$	2,222	$	4,974	$	8,101	$	13,716

In addition to the equity-based compensation expense presented in the table above, we incurred $0.7 million of equity-based compensation expense related to restructuring activities during the first quarter of 2019 (as discussed further in Note Q, below), which is classified within restructuring expense on our condensed consolidated statements of operations for the nine months ended September 30, 2019.

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Stockholders' Equity	9 Months Ended
	Sep. 30, 2020
Equity [Abstract]
Stockholders' Equity	STOCKHOLDERS’ EQUITY As of January 1, 2020, we had $26.8 million available under the share repurchase program initially approved by our Board of Directors in January 2016, which was updated in March 2019 to permit the repurchase of up to an aggregate of $80.0 million in shares of our common stock. During the nine months ended September 30, 2020, we did not repurchase shares of common stock under this program. As of September 30, 2020, $26.8 million remains available for future repurchases under this program.

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Commitments and Contingencies

9 Months Ended

Sep. 30, 2020

Commitments and Contingencies Disclosure [Abstract]

Commitments and Contingencies

COMMITMENTS AND CONTINGENCIES

Commitments

Our long-term contractual obligations include commitments and estimated purchase obligations entered into in the normal course of business. These include commitments related to our facility and vehicle leases, purchases of inventory, debt obligations, and other purchase obligations.

Operating Lease Obligations

As of September 30, 2020, we had operating lease liabilities of $21.9 million and related right-of-use assets of $21.1 million related to operating leases for real estate, including our corporate headquarters, vehicles and office equipment. As of September 30, 2020, our leases have remaining terms of one to eight years. The weighted average remaining lease term and discount rate for our operating leases was 7.4 years and 5.1% at September 30, 2020, respectively.

Lease costs for our operating leases were $1.2 million and $3.8 million for the three and nine months ended September 30, 2020, respectively and $1.4 million and $3.9 million for the three and nine months ended September 30, 2019, respectively. Operating cash outflows for operating leases were $3.6 million and $4.2 million for the nine months ended September 30, 2020 and 2019, respectively.

Future minimum payments under our non-cancelable operating leases as of September 30, 2020 are as follows (in thousands):

Period	Future Minimum Lease Payments
Remainder of Year Ending December 31, 2020	$	947
Year Ending December 31, 2021	3,248
Year Ending December 31, 2022	3,887
Year Ending December 31, 2023	3,291
Year Ending December 31, 2024	3,246
Thereafter	12,192
Total	$	26,811
Less: Interest	(4,924)
Operating lease liability	$	21,887

Purchase Obligations

Purchase obligations primarily represent minimum purchase commitments for inventory. As of September 30, 2020, our minimum purchase commitments totaled $25.9 million.

Contingent Regulatory and Commercial Milestone Payments

We are required to make payments contingent on the achievement of certain regulatory and/or commercial milestones under the terms of our collaboration, license and other strategic agreements. Please refer to Note O, “Acquisitions, Collaboration, License and Other Strategic Agreements” for additional details regarding these contingent payments.

Contingencies

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 certain 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. We expense legal costs as they are incurred.

On June 5, 2020, Carrie Winchester and Matt Winchester filed a complaint against a list of defendants for claimed exposures to asbestos. AMAG Pharma USA, Inc. d/b/a Lumara Health Inc. was named as a defendant because Nesher Pharmaceuticals, Inc., a subsidiary of K-V Pharmaceutical Company (“KV”) (Lumara Health’s predecessor company), sold Nystatin powder that Ms. Winchester claims she may have used during her employment as a medical professional. We acquired Lumara Health in November 2014, a year after KV emerged from bankruptcy protection, at which time it, along with its then existing subsidiaries, became our wholly-owned subsidiary. The plaintiffs allege that Ms. Winchester developed injuries as a direct and proximate result of inhalation of asbestos dust particles and fibers from defendants’ products. On August 19, 2020, the plaintiffs dismissed the defendants, AMAG Pharma USA, Inc. d/b/a Lumara Health Inc. and Nesher Pharmaceuticals, Inc. without prejudice from this claim.

On November 6, 2019, we were served with a summons in a case filed in the U.S. District Court, Northern District of Ohio, captioned Civil Case in Saginaw Chippewa Indian Tribe v. Purdue Pharma et al (Case No. 1-19-op-45841). The complaint names KV, certain of its successor entities, subsidiaries and affiliate entities as defendants, along with over forty other pharmaceutical companies. The plaintiff in this action alleges that KV’s subsidiary, Ethex Corporation (as well as the other pharmaceutical companies named in the complaint), manufactured, promoted, sold, and distributed opioids, including a generic version of morphine. Defendants KV and Ethex Corporation were dismissed without prejudice from this Chippewa case pursuant to an order dated March 26, 2020. KV and Ethex were also named but not served in several other similar cases and were dismissed without prejudice from these other cases by orders dated March 26, 2020.

On November 1, 2019, we were named as a defendant in a class action lawsuit filed in the United States District Court for the Western District of Missouri, captioned Barnes v. AMAG Pharmaceuticals, Inc., Case No. 3:19-cv-05088-RK (W.D. Mo.). Subsequently, other plaintiffs represented by the same law firm filed similar class action lawsuits in other jurisdictions, and the lawsuits have been consolidated in the United States District Court for the District of New Jersey, Zamfirova et al. v. AMAG Pharmaceuticals, Inc., Case No. 20-00152-JMV-SCM (April 2, 2020). The plaintiffs in this action, on behalf of themselves and purported state-wide classes of similarly situated consumers in California, Kansas, Missouri, New Jersey, New York, and Wisconsin, assert claims for violation of state consumer protection laws and unjust enrichment based on allegations that we and/or our predecessor companies made misrepresentations and omissions regarding the effectiveness of Makena in connection with the sale and marketing of that product from 2011 through the present. On June 8, 2020, we filed a motion to dismiss the consolidated complaint. Plaintiffs responded with a brief in opposition to the motion on July 6, 2020. Our reply brief was filed on July 20, 2020. We are currently unable to predict the outcome or reasonably estimate the range of potential loss associated with this matter, if any.

On August 29, 2019, Lunar Representative, LLC (“Plaintiff”), on behalf of the former equity holders of Lumara Health Inc. (“Lumara”), filed a complaint against us in the Delaware Court of Chancery, captioned Lunar Representative, LLC v. AMAG Pharmaceuticals, Inc. (No. 2019-0688-JTL). On September 25, 2019, we filed a motion to dismiss the complaint. On January 9, 2020, Plaintiff filed an amended complaint. Plaintiff alleges that we did not exercise commercially reasonable efforts to market and sell the drug product Makena, and failed to achieve sales milestones for Makena, in breach of certain provisions of the September 28, 2014 Agreement and Plan of Merger between, among other parties, us and Lumara. On January 24, 2020, we filed a motion to dismiss the amended complaint and filed our opening brief in support of such motion to dismiss the amended complaint on April 14, 2020. Plaintiff filed an answer in opposition to the motion to dismiss on June 25, 2020. On August 21, 2020, the court denied our motion to dismiss. On September 18, 2020, we filed an answer to the amended complaint. Plaintiff is seeking damages of $50.0 million, together with pre- and post-judgment interest, as well as attorneys’ fees and costs. At this time, based on available information, we are unable to reasonably assess the ultimate outcome of this case or determine an estimate, or a range of estimates, of potential losses. We believe this lawsuit is without merit and intend to vigorously defend against the allegations.

On or about April 6, 2016, we received Notice of a Lawsuit and Request to Waive Service of a Summons in a case entitled Plumbers’ Local Union No. 690 Health Plan v. Actavis Group et. al. (“Plumbers’ Union”), which was filed in the Court of Common Pleas of Philadelphia County, First Judicial District of Pennsylvania and, after removal to federal court, is now pending in the United States District Court for the Eastern District of Pennsylvania (Civ. Action No. 16-65-AB). Thereafter, we were also made aware of a related complaint entitled Delaware Valley Health Care Coalition v. Actavis Group et. al. (“Delaware Valley”), which was filed with the Court of Common Pleas of Philadelphia County, First Judicial District of Pennsylvania District Court of Pennsylvania (Case ID: 160200806). Both the Plumbers’ Union and the Delaware Valley complaints name K-V Pharmaceutical Company (“KV”) (Lumara Health’s predecessor company), certain of its successor entities, subsidiaries and affiliate entities (the “Subsidiaries”), along with a number of other pharmaceutical companies. We acquired Lumara Health in November 2014, a year after KV emerged from bankruptcy protection, at which time it, along with its then existing subsidiaries, became our wholly-owned subsidiary. We have not been served with process or waived service of summons in either case. The actions are being brought alleging unfair and deceptive trade practices with regard to certain pricing practices that allegedly resulted in certain payers overpaying for certain of KV’s generic products. On July 21, 2016, the

Plaintiff in the Plumbers’ Union case dismissed KV with prejudice to refiling and on October 6, 2016, all claims against the Subsidiaries were dismissed without prejudice. We are in discussions with Plaintiff’s counsel to similarly dismiss all claims in the Delaware Valley case. Because we have not been served with process in the Delaware Valley case, we are currently unable to predict the outcome or reasonably estimate the range of potential loss associated with this matter, if any.

On July 20, 2015, the Federal Trade Commission (the “FTC”) notified us that it is conducting an investigation into whether Lumara Health or its predecessor engaged in unfair methods of competition with respect to Makena or any hydroxyprogesterone caproate product. As previously disclosed, we provided the FTC with a response in August 2015. We believe we have fully cooperated with the FTC and we have had no further interactions with the FTC on this matter since we provided our response to the FTC in August 2015. For further information on this matter, see Note N, “Commitments and Contingencies” to our Annual Report.

We may periodically become subject to other legal proceedings and claims arising in connection with ongoing business activities, including claims or disputes related to patents that have been issued or that are pending in the field of research on which we are focused. Other than the above actions, we are not aware of any material claims against us as of September 30, 2020.

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Acquisitions, Collaboration, License and Other Strategic Agreements

9 Months Ended

Sep. 30, 2020

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Acquisitions, Collaboration, License and Other Strategic Agreements

ACQUISITIONS, COLLABORATION, LICENSE AND OTHER STRATEGIC AGREEMENTS

During the nine months ended September 30, 2020, we were a party to the following collaboration, license or other strategic agreements:

Norgine

In July 2020, we entered into a License and Commercialization Agreement with Norgine B.V. (“Norgine”, and such agreement, the “Norgine Agreement”), pursuant to which we granted Norgine an exclusive license to develop and commercialize ciraparantag in certain countries in Europe, Australia and New Zealand. We received a $30.0 million upfront, non-refundable payment upon signing. In addition, pursuant to the terms and conditions of the Norgine Agreement (a) Norgine will pay us one-third of the actual and reasonable out-of-pocket costs of the Phase 3 program, pursuant to a mutually agreed upon budget, (b) we are eligible to receive up to $70.0 million upon the achievement of certain regulatory milestones (of which we will pay $40.0 million to the former equity holders of Perosphere pursuant to the terms of the Perosphere Agreement (described below), (c) we are eligible to receive up to $190.0 million contingent upon meeting certain sales milestones, and (d) Norgine will pay us tiered double-digit royalties on net sales in the licensed territory. We will be responsible for manufacturing and supplying Norgine with its requirements of clinical and commercial product pursuant to supply agreement(s) to be entered into by the parties.

Perosphere

On January 16, 2019, we acquired Perosphere pursuant to the Agreement and Plan of Merger (the “Perosphere Agreement”), dated as of December 12, 2018 between AMAG and Perosphere. We accounted for this transaction as an asset acquisition under ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business (“ASU 2017-01”).

Under and subject to the terms and conditions set forth in the Perosphere Agreement, we are obligated to pay future contingent consideration of up to an aggregate of $365.0 million (the “Milestone Payments”), including (a) up to an aggregate of $140.0 million that becomes payable upon the achievement of specified regulatory milestones for ciraparantag (the “Regulatory Milestone Payments”), including a $40.0 million milestone payment upon approval of ciraparantag by the European Medicines Agency and (b) up to an aggregate of $225.0 million that becomes payable conditioned upon the achievement of specified sales milestones (the “Sales Milestone Payments”). If the final label approved for ciraparantag in the U.S. includes a boxed warning, the Regulatory Milestone Payments shall no longer be payable, and any previously paid Regulatory Milestone Payments shall be credited against 50% of any future Milestone Payments that otherwise becomes payable. The first sales milestone payment of $20.0 million will be payable upon annual net sales of ciraparantag of at least $100.0 million.

Velo

In September 2018, we exercised our option to acquire the global rights to the AMAG-423 program, pursuant to an option agreement entered into in July 2015 (the “Velo Option Agreement”) with Velo Bio, LLC (“Velo”), the terms of which were amended at the time of exercise. We accounted for this transaction as an asset acquisition under ASU No. 2017-01. Under the terms of the agreement, we are obligated to pay Velo a $30.0 million milestone payment upon FDA approval of AMAG-423. In

addition, we are obligated to pay sales milestone payments to Velo of up to $240.0 million in the aggregate, triggered at various annual net sales thresholds between $300.0 million and $900.0 million and low-single digit royalties based on net sales. Further, we have assumed additional obligations under a previous agreement entered into by Velo with a third-party, including a $5.0 million milestone payment upon regulatory approval and $10.0 million following the first commercial sale of AMAG-423, payable in quarterly installments as a percentage of quarterly gross commercial sales until the obligation is met. We are also obligated to pay the third-party low-single digit royalties based on net sales.

In July 2020, we decided to stop the AMAG-423 Phase 2b/3a study. This decision was based primarily on DSMB unanimous recommendation to stop the study following an interim analysis of the data collected to date in the study. There were no safety concerns raised during this study and safety was not a contributing factor to our decision to terminate the study. We are currently focused on ensuring an appropriate closeout of the study in partnership with investigators and other relevant stakeholders.

In connection with the cessation of the AMAG-423 Phase 2b/3a study, on August 6, 2020, we terminated our supply agreement (including termination of significant minimum purchase obligations) with our third party supplier, Protherics UK Ltd, a subsidiary of BTG plc (“BTG”), in exchange for a one-time payment by us of $12.5 million and our grant to BTG of a 9-month option (subject to extension under certain situations) to acquire the AMAG-423 program rights and assume our related obligations, including our obligations under the Velo Option Agreement.

Antares

We are party to a development and license agreement (the “Antares License Agreement”) with Antares Pharma, Inc. (“Antares”), which grants us an exclusive, worldwide, royalty-bearing license, with the right to sublicense, to certain intellectual property rights, including know-how, patents and trademarks, to develop, use, sell, offer for sale and import and export the Makena auto-injector. Under the terms of the Antares License Agreement, as amended in March 2018, we are responsible for the clinical development and preparation, submission and maintenance of all regulatory applications in each country where we desire to market and sell the Makena auto-injector, including the U.S. We are required to pay royalties to Antares on net sales of the Makena auto-injector until the Antares License Agreement is terminated (the “Antares Royalty Term”). The royalty rates range from high single digit to low double digits and are tiered based on levels of net sales of the Makena auto-injector and decrease after the expiration of licensed patents or where there are generic equivalents to the Makena auto-injector being sold in a particular country. In addition, we are required to pay Antares sales milestone payments upon the achievement of certain annual net sales. The Antares License Agreement terminates at the end of the Antares Royalty Term, but is subject to early termination by us for convenience and by either party upon an uncured breach by or bankruptcy of the other party. In March 2018, the Antares License Agreement was amended to, among other things, transfer the agreement to AMAG from our subsidiary, amend certain confidentiality provisions, and to provide for co-termination with the Antares Manufacturing Agreement (described below).

We are also party to a Manufacturing Agreement with Antares (the “Antares Manufacturing Agreement”) that sets forth the terms and conditions pursuant to which Antares agreed to sell to us on an exclusive basis, and we agreed to purchase, the fully packaged Makena auto-injector for commercial distribution. Antares remains responsible for the manufacture and supply of the device components and assembly of the Makena auto-injector. We are responsible for the supply of the drug to be used in the assembly of the finished auto-injector product. The Antares Manufacturing Agreement terminates at the expiration or earlier termination of the Antares License Agreement, but is subject to early termination by us for certain supply failure situations, and by either party upon an uncured breach by or bankruptcy of the other party or our permanent cessation of commercialization of the Makena auto-injector for efficacy or safety reasons.

Endoceutics

In February 2017, we entered into the Endoceutics License Agreement with Endoceutics, Inc. (“Endoceutics”) to obtain an exclusive right to commercialize Intrarosa for the treatment of vulvar and vaginal atrophy (“VVA”) and female sexual dysfunction (“FSD”) in the United States. The transactions contemplated by the Endoceutics License Agreement closed on April 3, 2017. We accounted for the Endoceutics License Agreement as an asset acquisition under ASU 2017-01.

In April 2017, we entered into an exclusive commercial supply agreement with Endoceutics pursuant to which Endoceutics, itself or through affiliates or contract manufacturers, agreed to manufacture and supply Intrarosa to us (the “Endoceutics Supply Agreement”) and was our exclusive supplier of Intrarosa in the U.S., subject to certain rights for us to manufacture and supply Intrarosa in the event of a cessation notice or supply failure (as such terms are defined in the Endoceutics Supply Agreement).

On May 21, 2020, we sold our rights to commercialize and have manufactured Intrarosa in the United States to Millicent Pharma Limited (“Millicent”) pursuant to an Asset Purchase Agreement between the Company and Millicent, dated May 21, 2020. Under the terms of the Asset Purchase Agreement, we received an upfront payment of $20.9 million in cash, subject to customary purchase price adjustments, including in connection with the transfer of certain inventory. We are eligible to receive up to $105.0 million in aggregate milestone payments upon the achievement of certain sales milestones, namely: (a) $25.0 million the first time net sales during any consecutive twelve month period exceeds $65.0 million, (b) $35.0 million the first time net sales during any consecutive twelve month period exceeds $115.0 million and (c) $45.0 million the first time net sales during any consecutive twelve month period exceeds $175.0 million. We recognized a gain of $14.4 million within Loss on Disposal of Assets, Net on our condensed consolidated statements of operations for the three and nine months ended September 30, 2020 related to this transaction. The gain recognized is net of transaction fees of $2.5 million and the carrying value of the Intrarosa assets and other costs of $4.0 million.

As part of the transaction with Millicent, we assigned both the Endoceutics License Agreement and the Endoceutics Supply Agreement to Millicent, and we agreed to provide certain transitional services to Millicent for a period of time following the closing pursuant to a transition services agreement.

Palatin

In January 2017, we entered into a license agreement with Palatin Technologies, Inc. (“Palatin”) under which we acquired (a) an exclusive license in all countries of North America (the “AMAG Territory”), with the right to grant sub-licenses, to research, develop and commercialize the Vyleesi Products, (b) a worldwide non-exclusive license, with the right to grant sub-licenses, to manufacture the Vyleesi Products, and (c) a non-exclusive license in all countries outside the AMAG Territory, with the right to grant sub-licenses, to research and develop (but not commercialize) the Vyleesi Products (the “Palatin License Agreement”). The transaction closed in February 2017 and was accounted for as an asset acquisition under ASU 2017-01.

In July 2020, we entered into a termination agreement with Palatin detailing the terms and conditions for the termination of the Company’s rights and obligations to develop and commercialize Vyleesi under the Palatin License Agreement and for the transfer of full ownership of Vyleesi to Palatin (the “Termination Agreement”). In accordance with the terms of the Termination Agreement, we transferred and assigned to Palatin the regulatory approval for Vyleesi, inventory, certain third party contracts, intellectual property rights and regulatory files and commercial materials of AMAG related to Vyleesi in the AMAG Territory. In consideration for the early termination of the License Agreement, the assumption of certain liabilities by Palatin (including significant minimum purchase obligations), and in lieu of any future milestone payments, royalties and other payments by AMAG to Palatin contemplated by the Palatin License Agreement, we paid Palatin $12.0 million following the termination, and we will pay an additional $4.3 million on March 31, 2021. We recognized a loss of $22.4 million in Loss on Disposal of Assets, net on our condensed consolidated statements of operations for the three and nine months ended September 30, 2020 related to this transaction. The loss recognized includes the carrying value of the Vyleesi assets and other costs, totaling $6.1 million in the aggregate. In addition, we agreed to provide certain transitional services to Palatin for a period of time following the closing pursuant to a transition services agreement.

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Debt

9 Months Ended

Sep. 30, 2020

Debt Disclosure [Abstract]

Debt

DEBT

Our outstanding debt obligations as of September 30, 2020 and December 31, 2019 consisted of the following (in thousands):

	September 30, 2020		December 31, 2019
2022 Convertible Notes	$	289,334	$	277,034
Total long-term debt	289,334		277,034
Less: current maturities	—		—
Long-term debt, net of current maturities	$	289,334	$	277,034

Convertible Notes

The outstanding balance of our 2022 Convertible Notes as of September 30, 2020 consisted of the following (in thousands):

	2022 Convertible Notes
Liability component:
Principal	$	320,000
Less: debt discount and issuance costs, net	30,666
Net carrying amount	$	289,334
Gross equity component	$	72,576

In accordance with accounting guidance for debt with conversion and other options, we separately account for the liability and equity components of our 2022 Convertible Notes by allocating the proceeds between the liability component and the embedded conversion option (the “Equity Component”) due to our ability to settle the 2022 Convertible Notes in cash, common stock or a combination of cash and common stock, at our option. The carrying amount of the liability component was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The allocation was performed in a manner that reflected our non-convertible debt borrowing rate for similar debt. The Equity Component of the 2022 Convertible Notes was recognized as a debt discount and represents the difference between the proceeds from the issuance of the 2022 Convertible Notes and the fair value of the liability of the 2022 Convertible Notes on the date of issuance. The excess of the principal amount of the liability component over its carrying amount is amortized to interest expense using the effective interest method over five years. The Equity Component is not remeasured as long as it continues to meet the conditions for equity classification.

2022 Convertible Notes

In the second quarter of 2017, we issued $320.0 million aggregate principal amount of convertible senior notes due in 2022 (the “2022 Convertible Notes”) and received net proceeds of $310.4 million from the sale of the 2022 Convertible Notes, after deducting fees and expenses of $9.6 million. The approximate $9.6 million of debt issuance costs primarily consisted of underwriting, legal and other professional fees, and we allocated these costs to the liability and equity components based on the allocation of the proceeds. Of the total $9.6 million of debt issuance costs, $2.2 million was allocated to the Equity Component and recorded as a reduction to additional paid-in capital and $7.4 million was allocated to the liability component and is now recorded as a reduction of the 2022 Convertible Notes on our condensed consolidated balance sheets. The portion allocated to the liability component is amortized to interest expense using the effective interest method over five years.

The 2022 Convertible Notes are governed by the terms of an indenture between us, as issuer, and Wilmington Trust, National Association, as the trustee. The 2022 Convertible Notes are senior unsecured obligations and bear interest at a rate of 3.25% per year, payable semi-annually in arrears on June 1 and December 1 of each year, beginning on December 1, 2017. The 2022 Convertible Notes will mature on June 1, 2022, unless earlier repurchased or converted. Upon conversion of the 2022 Convertible Notes, such 2022 Convertible Notes will be convertible into, at our election, cash, shares of our common stock, or a combination thereof, at a conversion rate of 36.5464 shares of common stock per $1,000 principal amount of the 2022 Convertible Notes, which corresponds to an initial conversion price of approximately $27.36 per share of our common stock.

The conversion rate is subject to adjustment from time to time upon the occurrence of certain events, including, but not limited to, the issuance of stock dividends and payment of cash dividends. At any time prior to the close of business on the business day immediately preceding March 1, 2022, holders may convert their 2022 Convertible Notes at their option only under the following circumstances:

1)during any calendar quarter (and only during such calendar quarter), if the last reported sale price of our common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day;

2)during the five business day period after any five consecutive trading day period (the “measurement period”) in which the trading price per $1,000 principal amount of the 2022 Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of our common stock and the conversion rate on each such trading day; or

3)upon the occurrence of specified corporate events.

On or after March 1, 2022, until the close of business on the business day immediately preceding the maturity date, holders may convert all or any portion of their 2022 Convertible Notes, in multiples of $1,000 principal amount, at the option of the holder regardless of the foregoing circumstances. The 2022 Convertible Notes were not convertible as of September 30, 2020.

We determined the expected life of the debt was equal to the five-year term on the 2022 Convertible Notes. The effective interest rate on the liability component was 9.49% for the period from the date of issuance through September 30, 2020. As of September 30, 2020, the “if-converted value” did not exceed the remaining principal amount of the 2022 Convertible Notes.

2019 Convertible Notes

In February 2014, we issued $200.0 million aggregate principal amount of the 2019 Convertible Notes. During 2017, we entered into privately negotiated transactions with certain investors to repurchase approximately $178.5 million aggregate principal amount of the 2019 Convertible Notes for an aggregate repurchase price of approximately $192.7 million, including accrued interest. The remaining $21.4 million of 2019 Convertible Notes matured on February 15, 2019 and were settled with cash.

Convertible Notes Interest Expense

The following table sets forth total interest expense recognized related to the Convertible Notes during the three and nine months ended September 30, 2020 and 2019 (in thousands):

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Contractual interest expense	$	2,600	$	2,600	$	7,800	$	7,867
Amortization of debt issuance costs	388		353		1,137		1,051
Amortization of debt discount	3,810		3,466		11,164		10,281
Total interest expense	$	6,798	$	6,419	$	20,101	$	19,199

Future Payments

Future annual principal payments on our long-term debt as of September 30, 2020 include $320.0 million due during the year ending December 31, 2022.

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Restructuring Expenses

9 Months Ended

Sep. 30, 2020

Restructuring and Related Activities [Abstract]

Restructuring Expenses

RESTRUCTURING EXPENSES

In May 2020, we completed a restructuring to reduce the size of our organization in conjunction with the planned divestiture of Intrarosa and Vyleesi and expected declines in our revenue due to the COVID-19 pandemic. Approximately 110 employees were displaced through this workforce reduction. We recorded a one-time restructuring charge of $8.2 million primarily related to severance and related benefits on our condensed consolidated statement of operations during the second quarter of 2020 and expect the restructuring charges incurred to date under this program to be substantially paid in cash by the end of the second quarter of 2021.

In February 2019, we completed a restructuring to combine our women’s health and maternal health sales forces into one integrated sales team, which promotes Intrarosa, the Makena auto-injector and Vyleesi. Approximately 110 employees were displaced through this workforce reduction. We recorded one-time restructuring charges of $7.4 million primarily related to severance and related benefits on our condensed consolidated statement of operations during the first quarter of 2019. The remaining accrued restructuring charges incurred under this program will be paid in cash by the end of the first quarter of 2021.

The following table displays charges taken related to the restructuring during the nine months ended September 30, 2020 (in thousands):

2020 Restructuring charges:
Workforce reduction	$	8,090
Other	107
Total 2020 restructuring charges	$	8,197

The following table displays a rollforward of the changes to the accrued balances as of September 30, 2020 (in thousands): 

	2019 Restructuring		2020 Restructuring		Total
Balance accrued at December 31, 2019	$	797	$	—	$	797
2020 Restructuring Charges	—		8,197		8,197
Workforce Reduction Payments	(626)		(6,665)		(7,291)
Other Payments	—		(107)		(107)
Balance accrued at September 30, 2020	$	171	$	1,425	$	1,596

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Revision of Prior Period Financial Statements

9 Months Ended

Sep. 30, 2020

Accounting Changes and Error Corrections [Abstract]

Revision of Prior Period Financial Statements

REVISION OF PRIOR PERIOD FINANCIAL STATEMENTS

Prior period amounts, specifically net product sales and accrued expenses have been revised to correct prior period errors related to gross-to-net (“GTN”) adjustments for governmental rebates and the related accrual for certain state programs.

During the third quarter of 2020, in conjunction with our remediation efforts related to the errors identified during the second quarter of 2020 described below, we identified certain individually immaterial errors aggregating to $5.2 million related to governmental rebate accruals associated with Makena sales during the first and second quarters of 2020. We understated our GTN adjustments for governmental rebates and the related accrual for certain state programs by $2.8 million for the quarter ended March 31, 2020 and $2.8 million for the quarter ended June 30, 2020. This understatement also resulted in an overstatement of our related royalty obligation of $0.2 million for the quarter ended March 31, 2020 and $0.2 million for the quarter ended June 30, 2020. During the third quarter of 2020, we concluded that the errors were not material to any prior interim periods. However, we determined that correcting the aggregate error during the third quarter of 2020 would be material to the three-month period ended September 30, 2020. As a result, we have revised our historical financial statements to properly reflect the GTN adjustments and related royalty impact and accrual in the appropriate periods through an immaterial correction.

The effect of the correction to our condensed consolidated statement of stockholders’ equity is as follows:

	June 30, 2020
	As reported		Adjustment		As adjusted
Accumulated deficit	$	(1,051,153)	$	(5,216)	$	(1,056,369)
Total stockholders' equity	$	249,322	$	(5,216)	$	244,106

As previously reported, subsequent to the issuance of our Form 10-Q for the quarter ended March 31, 2020, management identified certain individually immaterial errors aggregating to $6.3 million related to governmental rebate accruals associated with Makena sales from 2016 through the first quarter of 2020. From 2016 through 2019, we understated our GTN adjustments for governmental rebates and the related accrual for a certain state program by $6.3 million and for the quarter ended March 31, 2020, we overstated these amounts by $1.8 million. As previously reported, we concluded that the errors were not material to any prior annual or interim period; however, we determined that correcting the aggregate error during the second quarter of 2020 would be material to the three-month period ended June 30, 2020. As a result, we have revised our historical financial statements to properly reflect GTN adjustments and the related accrual in the appropriate periods.

The effect of the corrections to our condensed consolidated statements of operations for the three and nine months ended September 30, 2019 are as follows (in thousands, except per share amounts):

	Three Months Ended September 30, 2019						Nine Months Ended September 30, 2019
	As reported		Adj		As adjusted		As reported		Adj		As adjusted
Product sales, net	$	84,107	$	(323)	$	83,784	$	237,812	$	(981)	$	236,831
Total revenues	84,131		(323)		83,808		238,043		(981)		237,062
Net loss	$	(23,617)	$	(323)	$	(23,940)	$	(266,528)	$	(981)	$	(267,509)
Basic and diluted net loss per share	$	(0.70)	$	(0.01)	$	(0.71)	$	(7.83)	$	(0.02)	$	(7.85)

The condensed consolidated statements of other comprehensive loss for the three and nine months ended September 30, 2019 have been revised to include the changes to “net loss” summarized above.

The condensed consolidated statement of stockholders’ equity for the three months ended September 30, 2020 has been revised to reflect an increase of $5.2 million to the beginning “accumulated deficit” as of July 1, 2020, representing the accumulated error through that date. The condensed consolidated statements of stockholders’ equity for the three and nine months ended September 30, 2019 have been revised to include the changes to “net loss” summarized above as well as an increase of $5.1 million to the beginning “accumulated deficit” as of January 1, 2019, representing the accumulated error through that date.

The impact on our condensed consolidated statements of cash flows for the nine months ended September 30, 2019, was limited to the offsetting correction between “net loss” and changes in “accounts payable and accrued expenses” presented within “net cash used in operating activities”, as summarized in the above tables.

Refer to Amendment No. 1 on Form 10-K/A to our Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on September 15, 2020 for the impact on periods reported in the Company’s 2019 Annual Report on Form 10-K filed with the SEC on March 6, 2020 and for the impact on our condensed consolidated statement of operations for the impacted periods.

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Recently Issued and Proposed Accounting Pronouncements

9 Months Ended

Sep. 30, 2020

Accounting Changes and Error Corrections [Abstract]

Recently Issued and Proposed Accounting Pronouncements

RECENTLY ISSUED AND PROPOSED ACCOUNTING PRONOUNCEMENTS

From time to time, new accounting pronouncements are issued by FASB or other standard setting bodies that are adopted by us as of the specified effective date.

In August 2020, the FASB issued ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”). This standard simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts in an entity’s own equity. ASU 2020-06 is effective for annual reporting periods beginning after December 15, 2021 and interim periods within those annual periods. Early adoption is permitted but no earlier than annual reporting periods beginning after December 15, 2020 and interim periods within those annual periods. We are currently evaluating the impact of adoption of ASU 2020-06 on our condensed consolidated financial statements.

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Subsequent Events

9 Months Ended

Sep. 30, 2020

Subsequent Events [Abstract]

Subsequent Events

SUBSEQUENT EVENTS

Agreement and Plan of Merger

On October 1, 2020, we entered into the Merger Agreement with Covis and Merger Sub, pursuant to which Merger Sub has launched the Offer. The Merger Agreement has been unanimously approved by the boards of directors of AMAG and Covis. The Offer commenced on October 15, 2020 and will remain open for a minimum of 20 business days. The completion of the Offer is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of AMAG’s common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (which condition was satisfied on October 23, 2020), and other customary conditions. Upon the completion of the Offer, Merger Sub will merge with and into AMAG, with AMAG continuing as the surviving corporation (the “Merger”) and any outstanding shares of common that were not tendered in the Offer (or owned by Covis) will be automatically cancelled and converted into the right to receive an amount in cash equal to $13.75 per share, without interest. In addition, immediately prior to, and contingent upon, the closing of the Merger, each outstanding AMAG in-the-money stock option and restricted stock unit, whether vested or unvested, will be cancelled and automatically converted into the right to receive a cash payment in accordance with the terms of the Merger Agreement. The Offer and Merger are not subject to a financing condition.

The Merger Agreement contains customary representations, warranties and covenants, including covenants obligating AMAG to continue to conduct its business in the ordinary course, to cooperate in seeking regulatory approvals and not to engage in certain specified transactions or activities without Covis’s prior consent. The Merger Agreement also contains certain termination rights for each of AMAG and Covis, including the right to terminate the agreement if the Offer has not been consummated by January 28, 2021 or if the other party has materially breached and not cured any representation, warranty or covenant in the Merger Agreement. If we terminate the Merger Agreement under certain specified circumstances, we would be required to pay Covis a termination fee of $16.25 million.

Securities Litigation

In connection with the proposed Merger with Covis, seven complaints have been filed against the Company and its directors and certain officers, one of which also names Covis and certain of its affiliates as defendants. The complaints contain substantially similar allegations and generally allege that the Company’s solicitation/recommendation statement filed with the SEC on October 15, 2020 misrepresents and/or omits certain purportedly material information relating to financial projections and the analysis performed by the Company’s financial advisor in connection with the transaction and therefore violated Sections 14(e), 14(d)(4) and 20(a) of the Securities Exchange Act of 1934. The complaints seek, among other things, an injunction enjoining the consummation of the proposed transaction (or, if consummated, rescinding the transaction or awarding rescissory damages), costs related to the actions, including plaintiff’s attorneys’ fees and experts’ fees, declaratory relief, and any other relief the court may deem just and proper. In addition, one complaint also asserts that the directors breached their fiduciary duty of candor/disclosure by omitting purportedly material information from the solicitation/recommendation statement. We are currently unable to predict the outcome or reasonably estimate the range of potential loss associated with these claims, if any. It is possible that additional similar cases may also be filed in connection with the Merger.

FDA’s Proposal Regarding Makena

On October 5, 2020, we received a notice from the Center for Drug Evaluation and Research of the Food and Drug Administration (“FDA”) that the FDA is proposing to withdraw approval of Makena and that AMAG has the opportunity to request a hearing on the withdrawal. On October 14, 2020, we filed a request for a hearing with the FDA, together with an extension request for providing the supplemental information in support of our request for a hearing. On October 22, 2020, the FDA agreed to an extension and we plan to submit to the FDA by December 4, 2020 data, information, and analyses to demonstrate that there is a genuine and substantial issue of material fact that requires a hearing.

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Basis of Presentation and Summary of Significant Accounting Policies (Policies)

9 Months Ended

Sep. 30, 2020

Accounting Policies [Abstract]

Basis of Presentation

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 our financial position and results of operations 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 (“GAAP”).

In accordance with GAAP 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 Consolidated Financial Statements in our

Annual Report on Form 10-K for the year ended December 31, 2019, as amended (our “Annual Report”). 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.

Principles of Consolidation

Principles of Consolidation

The accompanying condensed consolidated financial statements include our accounts and the accounts of our wholly-owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.

Use of Estimates and Assumptions

Use of Estimates and Assumptions

The preparation of our condensed consolidated financial statements in conformity with GAAP requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent liabilities. We base our estimates on historical experience and on various other assumptions that we believe are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities, equity and the amount of revenues and expenses. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition, including product sales revenue; product sales allowances and accruals; allowance for expected credit losses; marketable securities; inventory; fair value estimates used to assess impairment of long-lived assets, including goodwill and other intangible assets; debt obligations; certain accrued liabilities, including clinical trial accruals; equity-based compensation expense; and income taxes, inclusive of valuation allowances, will depend on future developments that are highly uncertain, including new information that may emerge concerning COVID-19 and the actions taken to contain or treat its impact, as well as the economic impact on local, regional and national customers and markets. We have made estimates of the impact of COVID-19 within our financial statements and there may be changes to those estimates in future periods. Actual results could differ materially from these estimates.

Concentrations and Significant Customer Information

Concentrations and Significant Customer InformationFinancial instruments which potentially subject us to concentrations of credit risk consist principally of cash and cash equivalents, marketable securities, and accounts receivable. As of September 30, 2020, we held our excess cash primarily in institutional money market funds, corporate debt securities, commercial paper, U.S. treasury and government agency securities and certificates of deposit.Our operations are located entirely within the U.S. We focus primarily on developing, manufacturing, and commercializing our products and product candidates. Our net accounts receivable primarily represent amounts due for products sold directly to wholesalers, distributors and specialty pharmacies. Accounts receivable for our products are recorded net of reserves for estimated chargeback obligations, prompt payment discounts and any allowance for expected credit losses.We are currently dependent on a single supplier for certain of our manufacturing processes, including for Feraheme drug substance (produced in two separate facilities) and for our Makena auto-injector product. We have been and may continue to be exposed to a significant loss of revenue from the sale of our products in the event that our suppliers and/or manufacturers are not able to fulfill demand for any reason.

Recently Adopted, Issued and Proposed Accounting Pronouncements

Recently Adopted Accounting Pronouncements

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“Topic 326”). We adopted Topic 326 effective January 1, 2020 using a modified retrospective approach. The adoption of Topic 326 did not have a material impact on our condensed consolidated financial statements and accordingly, no transition adjustment was recorded at the adoption date. Under Topic 326, we estimate expected credit losses for our trade receivables held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. We also evaluate any impaired marketable securities against the new impairment model within Topic 326 to determine whether any loss or allowance for credit loss should be recorded at the reporting date.

In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”) as part of its Simplification Initiative to reduce the cost and complexity in accounting for income taxes. ASU 2019-12 removes certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. ASU 2019-12 also amends other aspects of the guidance to help simplify and promote consistent application of GAAP. The guidance is effective for interim and annual periods beginning after December 15, 2020, with early adoption permitted. We adopted ASU 2019-12 effective January 1, 2020. The adoption of ASU 2019-12 did not have a material impact on our condensed consolidated financial statements.

RECENTLY ISSUED AND PROPOSED ACCOUNTING PRONOUNCEMENTS

From time to time, new accounting pronouncements are issued by FASB or other standard setting bodies that are adopted by us as of the specified effective date.

In August 2020, the FASB issued ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”). This standard simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts in an entity’s own equity. ASU 2020-06 is effective for annual reporting periods beginning after December 15, 2021 and interim periods within those annual periods. Early adoption is permitted but no earlier than annual reporting periods beginning after December 15, 2020 and interim periods within those annual periods. We are currently evaluating the impact of adoption of ASU 2020-06 on our condensed consolidated financial statements.

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Basis of Presentation and Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2020

Accounting Policies [Abstract]

Schedule of customers representing 10% or more of total revenue

The following table sets forth customers who represented 10% or more of our total revenues for the three and nine months ended September 30, 2020 and 2019:

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
McKesson Corporation	36	%	38	%	36	%	37	%
AmerisourceBergen Drug Corporation	32	%	28	%	33	%	27	%
Cardinal Health	12	%	11	%	11	%	12	%

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Revenue Recognition (Tables)

9 Months Ended

Sep. 30, 2020

Revenue from Contract with Customer [Abstract]

Schedule of disaggregated of revenue

The following table provides information about disaggregated revenue by product for the three and nine months ended September 30, 2020 and 2019 (in thousands):

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Product sales, net
Feraheme	$	46,718	$	44,205	$	120,786	$	126,294
Makena	25,860		33,949		66,079		95,483
Intrarosa	37		5,607		4,423		14,898
Other	614		23		(586)		156
Total product sales, net	$	73,229	$	83,784	$	190,702	$	236,831

Total gross product sales were offset by product sales allowances and accruals for the three and nine months ended September 30, 2020 and 2019 as follows (in thousands):

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Gross product sales	$	218,739	$	254,073	$	633,475	$	704,976
Provision for product sales allowances and accruals:
Contractual adjustments	129,966		144,108		383,003		381,633
Governmental rebates	15,544		26,181		59,770		86,512
Total	145,510		170,289		442,773		468,145
Product sales, net	$	73,229	$	83,784	$	190,702	$	236,831

Schedule of product revenue allowance and accrual activity

The following table summarizes the product revenue allowance and accrual activity for the three and nine months ended September 30, 2020 (in thousands):

	Contractual		Governmental
	Adjustments		Rebates		Total
Balance at December 31, 2019	$	95,221	$	47,623	$	142,844
Provisions related to current period sales	147,235		20,982		168,217
Adjustments related to prior period sales	(4,060)		976		(3,084)
Payments/returns relating to current period sales	(95,284)		—		(95,284)
Payments/returns relating to prior period sales	(37,969)		(29,646)		(67,615)
Balance at March 31, 2020	$	105,143	$	39,935	$	145,078
Provisions related to current period sales	111,508		21,904		133,412
Adjustments related to prior period sales	(634)		378		(256)
Payments/returns relating to current period sales	(112,821)		(13,913)		(126,734)
Payments/returns relating to prior period sales	(19,484)		(10,240)		(29,724)
Balance at June 30, 2020	$	83,712	$	38,064	$	121,776
Provisions related to current period sales	129,402		17,410		146,812
Adjustments related to prior period sales	565		(1,867)		(1,302)
Payments/returns relating to current period sales	(115,634)		(14,259)		(129,893)
Payments/returns relating to prior period sales	(5,803)		(830)		(6,633)
Balance at September 30, 2020	$	92,242	$	38,518	$	130,760

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Marketable Securities (Tables)

9 Months Ended

Sep. 30, 2020

Investments, Debt and Equity Securities [Abstract]

Summary of marketable securities

The following is a summary of our marketable securities as of September 30, 2020 and December 31, 2019 (in thousands):

	September 30, 2020
			Gross		Gross		Estimated
	Amortized		Unrealized		Unrealized		Fair
	Cost		Gains		Losses		Value
Securities maturing within one year:
Corporate debt securities	$	23,861	$	145	$	(1)	$	24,005
Certificates of deposit	14,300		—		—		14,300
Commercial paper	9,488		—		—		9,488
Total securities maturing within one year	$	47,649	$	145	$	(1)	$	47,793
Securities maturing between one and three years:
Corporate debt securities	$	16,809	$	319	$	(2)	$	17,126
U.S. treasury and government agency securities	4,998		—		—		4,998
Certificates of deposit	1,000		—		—		1,000
Total securities maturing between one and three years	$	22,807	$	319	$	(2)	$	23,124
Total marketable securities	$	70,456	$	464	$	(3)	$	70,917

	December 31, 2019
			Gross		Gross		Estimated
	Amortized		Unrealized		Unrealized		Fair
	Cost		Gains		Losses		Value
Securities maturing within one year:
Corporate debt securities	$	46,186	$	140	$	(2)	$	46,324
U.S. treasury and government agency securities	2,750		—		—		2,750
Certificates of deposit	1,500		—		—		1,500
Total securities maturing within one year	$	50,436	$	140	$	(2)	$	50,574
Securities maturing between one and three years:
Corporate debt securities	$	8,016	$	152	$	—	$	8,168
Total securities maturing between one and three years	8,016		152		—		8,168
Total marketable securities	$	58,452	$	292	$	(2)	$	58,742

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Fair Value Measurements (Tables)

9 Months Ended

Sep. 30, 2020

Fair Value Disclosures [Abstract]

Schedule of assets and liabilities measured at fair value on a recurring basis

The following tables present information about our assets and liabilities that we measure at fair value on a recurring basis and indicate the level within the fair value hierarchy of the valuation techniques utilized to determine such fair value as of September 30, 2020 and December 31, 2019 (in thousands):

	Fair Value Measurements at September 30, 2020 Using:
			Quoted Prices in				Significant
			Active Markets for		Significant Other		Unobservable
			Identical Assets		Observable Inputs		Inputs
	Total		(Level 1)		(Level 2)		(Level 3)
Assets:
Cash equivalents	$	2,750	$	2,750	$	—	$	—
Corporate debt securities	41,131		—		41,131		—
U.S. treasury and government agency securities	4,998				4,998		—
Certificates of deposit	15,300		—		15,300		—
Commercial paper	9,488				9,488		—
Total assets	$	73,667	$	2,750	$	70,917	$	—

	Fair Value Measurements at December 31, 2019 Using:
			Quoted Prices in				Significant
			Active Markets for		Significant Other		Unobservable
			Identical Assets		Observable Inputs		Inputs
	Total		(Level 1)		(Level 2)		(Level 3)
Assets:
Cash equivalents	$	13,732	$	13,732	$	—	$	—
Corporate debt securities	54,492		—		54,492		—
U.S. treasury and government agency securities	2,750		—		2,750		—
Certificates of deposit	1,500		—		1,500		—
Total assets	$	72,474	$	13,732	$	58,742	$	—
Liabilities:
Contingent consideration - MuGard	$	17	$	—	$	—	$	17
Total liabilities	$	17	$	—	$	—	$	17

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Inventories (Tables)

9 Months Ended

Sep. 30, 2020

Inventory Disclosure [Abstract]

Schedule of major classes of inventories

Our major classes of inventories were as follows as of September 30, 2020 and December 31, 2019 (in thousands):

	September 30, 2020		December 31, 2019
Raw materials	$	3,424	$	5,211
Work in process	6,495		6,248
Finished goods	12,987		20,094
Total inventories	$	22,906	$	31,553

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Property and Equipment, Net (Tables)

9 Months Ended

Sep. 30, 2020

Property, Plant and Equipment [Abstract]

Schedule of property and equipment, net

Property and equipment, net consisted of the following as of September 30, 2020 and December 31, 2019 (in thousands):

	September 30, 2020		December 31, 2019
Computer equipment and software	$	1,568	$	1,568
Furniture and fixtures	1,714		1,714
Leasehold improvements	4,985		4,984
Laboratory and production equipment	6,281		6,570
Construction in progress	361		656
	14,909		15,492
Less: accumulated depreciation	(12,494)		(11,376)
Property and equipment, net	$	2,415	$	4,116

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Goodwill and Intangible Assets, Net (Tables)

9 Months Ended

Sep. 30, 2020

Goodwill and Intangible Assets Disclosure [Abstract]

Schedule of intangible assets

As of September 30, 2020 and December 31, 2019, our intangible assets consisted of the following (in thousands):

	September 30, 2020								December 31, 2019
			Accumulated		Cumulative						Accumulated		Cumulative
	Cost		Amortization		Impairments		Net		Cost		Amortization		Impairments		Net
Amortizable intangible assets:
Makena auto-injector developed technology	$	79,100	$	21,701	$	55,426	$	1,973	$	79,100	$	15,782	$	55,426	$	7,892
Intrarosa developed technology	—		—		—		—		77,655		16,798		56,881		3,976
Vyleesi developed technology	—		—		—		—		60,000		9,264		38,984		11,752
Total intangible assets	$	79,100	$	21,701	$	55,426	$	1,973	$	216,755	$	41,844	$	151,291	$	23,620

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Current Liabilities (Tables)

9 Months Ended

Sep. 30, 2020

Payables and Accruals [Abstract]

Schedule of accrued expenses

Accrued expenses consisted of the following as of September 30, 2020 and December 31, 2019 (in thousands):

	September 30, 2020		December 31, 2019
Commercial rebates, fees and returns	$	106,367	$	124,730
Manufacturing costs	8,778		21,364
Salaries, bonuses, and other compensation	13,121		18,693
Professional, license, and other fees and expenses	12,403		13,392
Research and development expense	865		3,539
Interest expense	3,467		867
Restructuring expense	1,596		797
Total accrued expenses	$	146,597	$	183,382

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Income Taxes (Tables)

9 Months Ended

Sep. 30, 2020

Income Tax Disclosure [Abstract]

Schedule of effective income tax rate and income tax expense (benefit)

The following table summarizes our effective tax rate and income tax (benefit) expense for the three and nine months ended September 30, 2020 and 2019 (in thousands except for percentages):

	Three Months Ended September 30,						Nine Months Ended September 30,
	2020			2019			2020			2019
Effective tax rate	(1)		%	(1)		%	—		%	—		%
Income tax (benefit) expense	$	(53)		$	232		$	(113)		$	(26)

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Earnings Per Share (Tables)

9 Months Ended

Sep. 30, 2020

Earnings Per Share [Abstract]

Schedule of components of basic and diluted earnings per share

The components of basic and diluted earnings per share for the three and nine months ended September 30, 2020 and 2019 were as follows (in thousands, except per share data):

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Net income (loss) - basic and diluted	$	9,702	$	(23,940)	$	(31,466)	$	(267,509)
Weighted average common shares outstanding	34,484		33,906		34,314		34,058
Effect of dilutive securities:
Stock options and RSUs	236		—		—		—
Shares used in calculating dilutive net income (loss) per share	34,720		33,906		34,314		34,058
Net income (loss) per share:
Basic	$	0.28	$	(0.71)	$	(0.92)	$	(7.85)
Diluted	$	0.28	$	(0.71)	$	(0.92)	$	(7.85)

Schedule of anti-dilutive securities from computation of diluted net income (loss) per share

The following table sets forth the potential common shares issuable upon the exercise of outstanding options, the vesting of restricted stock units (“RSUs”), and the conversion of the 2022 Convertible Notes, which were excluded from our computation of diluted net income (loss) per share because their inclusion would have been anti-dilutive (in thousands):

	Nine Months Ended September 30,
	2020	2019
Options to purchase shares of common stock	4,233	3,988
Shares of common stock issuable upon the vesting of RSUs	1,035	1,645
2022 Convertible Notes	11,695	11,695
Total	16,963	17,328

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Equity-Based Compensation (Tables)

9 Months Ended

Sep. 30, 2020

Share-based Payment Arrangement [Abstract]

Schedule of stock option activity

The following table summarizes stock option activity for the nine months ended September 30, 2020:

	2019	2007	Lumara Health	Inducement
	Plan	Plan	2013 Plan	Grants	Total
Outstanding at January 1, 2020	472,412	2,585,466	131,775	696,164	3,885,817
Granted	420,912	—	—	1,000,000	1,420,912
Exercised	(18,487)	—	(1,450)	—	(19,937)
Expired or terminated	(149,863)	(672,295)	(43,250)	(188,098)	(1,053,506)
Outstanding at September 30, 2020	724,974	1,913,171	87,075	1,508,066	4,233,286

Schedule of restricted stock activity

The following table summarizes RSU activity for the nine months ended September 30, 2020:

	2019	2007	Lumara Health	Inducement
	Plan	Plan	2013 Plan	Grants	Total
Outstanding at January 1, 2020	128,742	1,407,305	2,167	41,223	1,579,437
Granted	825,131	—	—	—	825,131
Vested	(78,689)	(460,185)	(899)	(10,862)	(550,635)
Expired or terminated	(209,697)	(591,972)	(534)	(17,169)	(819,372)
Outstanding at September 30, 2020	665,487	355,148	734	13,192	1,034,561

Schedule of equity-based compensation expense

Equity-based compensation expense for the three and nine months ended September 30, 2020 and 2019 consisted of the following (in thousands):

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Cost of product sales	$	131	$	225	$	438	$	626
Research and development	237		691		260		2,051
Selling, general and administrative	1,854		4,058		7,403		11,039
Total equity-based compensation expense	2,222		4,974		8,101		13,716
Income tax effect	—		—		—		—
After-tax effect of equity-based compensation expense	$	2,222	$	4,974	$	8,101	$	13,716

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Commitments and Contingencies (Tables)

9 Months Ended

Sep. 30, 2020

Commitments and Contingencies Disclosure [Abstract]

Schedule of Future Minimum Payments under Non-Cancelable Operating Leases

Future minimum payments under our non-cancelable operating leases as of September 30, 2020 are as follows (in thousands):

Period	Future Minimum Lease Payments
Remainder of Year Ending December 31, 2020	$	947
Year Ending December 31, 2021	3,248
Year Ending December 31, 2022	3,887
Year Ending December 31, 2023	3,291
Year Ending December 31, 2024	3,246
Thereafter	12,192
Total	$	26,811
Less: Interest	(4,924)
Operating lease liability	$	21,887

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Debt (Tables)

9 Months Ended

Sep. 30, 2020

Debt Disclosure [Abstract]

Schedule of outstanding debt obligations

Our outstanding debt obligations as of September 30, 2020 and December 31, 2019 consisted of the following (in thousands):

	September 30, 2020		December 31, 2019
2022 Convertible Notes	$	289,334	$	277,034
Total long-term debt	289,334		277,034
Less: current maturities	—		—
Long-term debt, net of current maturities	$	289,334	$	277,034

Schedule of outstanding convertible debt

The outstanding balance of our 2022 Convertible Notes as of September 30, 2020 consisted of the following (in thousands):

	2022 Convertible Notes
Liability component:
Principal	$	320,000
Less: debt discount and issuance costs, net	30,666
Net carrying amount	$	289,334
Gross equity component	$	72,576

Schedule of total interest expense recognized related to the convertible debt

The following table sets forth total interest expense recognized related to the Convertible Notes during the three and nine months ended September 30, 2020 and 2019 (in thousands):

	Three Months Ended September 30,				Nine Months Ended September 30,
	2020		2019		2020		2019
Contractual interest expense	$	2,600	$	2,600	$	7,800	$	7,867
Amortization of debt issuance costs	388		353		1,137		1,051
Amortization of debt discount	3,810		3,466		11,164		10,281
Total interest expense	$	6,798	$	6,419	$	20,101	$	19,199

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Restructuring Expenses (Tables)

9 Months Ended

Sep. 30, 2020

Restructuring and Related Activities [Abstract]

Schedule of restructuring charges

The following table displays charges taken related to the restructuring during the nine months ended September 30, 2020 (in thousands):

2020 Restructuring charges:
Workforce reduction	$	8,090
Other	107
Total 2020 restructuring charges	$	8,197

Schedule of changes to restructuring charges

The following table displays a rollforward of the changes to the accrued balances as of September 30, 2020 (in thousands): 

	2019 Restructuring		2020 Restructuring		Total
Balance accrued at December 31, 2019	$	797	$	—	$	797
2020 Restructuring Charges	—		8,197		8,197
Workforce Reduction Payments	(626)		(6,665)		(7,291)
Other Payments	—		(107)		(107)
Balance accrued at September 30, 2020	$	171	$	1,425	$	1,596

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Revision of Prior Period Financial Statements (Tables)

9 Months Ended

Sep. 30, 2020

Accounting Changes and Error Corrections [Abstract]

Schedule of effects of corrections and prior period adjustments

The effect of the correction to our condensed consolidated statement of stockholders’ equity is as follows:

	June 30, 2020
	As reported		Adjustment		As adjusted
Accumulated deficit	$	(1,051,153)	$	(5,216)	$	(1,056,369)
Total stockholders' equity	$	249,322	$	(5,216)	$	244,106

The effect of the corrections to our condensed consolidated statements of operations for the three and nine months ended September 30, 2019 are as follows (in thousands, except per share amounts):

	Three Months Ended September 30, 2019						Nine Months Ended September 30, 2019
	As reported		Adj		As adjusted		As reported		Adj		As adjusted
Product sales, net	$	84,107	$	(323)	$	83,784	$	237,812	$	(981)	$	236,831
Total revenues	84,131		(323)		83,808		238,043		(981)		237,062
Net loss	$	(23,617)	$	(323)	$	(23,940)	$	(266,528)	$	(981)	$	(267,509)
Basic and diluted net loss per share	$	(0.70)	$	(0.01)	$	(0.71)	$	(7.83)	$	(0.02)	$	(7.85)

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Description of Business (Details) - Subsequent Event - AMAG Pharmaceuticals, Inc. - Covis Group S.à r.l.	Oct. 01, 2020 $ / shares
Business Acquisition [Line Items]
Share price (in dollars per share)	$ 13.75
Offer period (minimum)	20 days

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Basis of Presentation and Summary of Significant Accounting Policies - Narrative (Details) - facility	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019
Revenue from Contract with Customer Benchmark | Customer Concentration Risk | McKesson Corporation
Concentrations and Significant Customer Information
Concentration risk	36.00%	38.00%	36.00%	37.00%
Revenue from Contract with Customer Benchmark | Customer Concentration Risk | AmerisourceBergen Drug Corporation
Concentrations and Significant Customer Information
Concentration risk	32.00%	28.00%	33.00%	27.00%
Revenue from Contract with Customer Benchmark | Customer Concentration Risk | Cardinal Health
Concentrations and Significant Customer Information
Concentration risk	12.00%	11.00%	11.00%	12.00%
Accounts Receivable | Customer Concentration Risk | Two Customers
Concentrations and Significant Customer Information
Concentration risk			76.00%
Accounts Receivable | Customer Concentration Risk | Three Customers
Concentrations and Significant Customer Information
Concentration risk					85.00%
Feraheme
Concentrations and Significant Customer Information
Number of production facilities			2

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Revenue Recognition - Disaggregated Revenue By Products (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Disaggregation of Revenue [Line Items]
Revenues	$ 93,106	$ 83,808	$ 210,637	$ 237,062
Feraheme
Disaggregation of Revenue [Line Items]
Revenues	46,718	44,205	120,786	126,294
Makena
Disaggregation of Revenue [Line Items]
Revenues	25,860	33,949	66,079	95,483
Intrarosa
Disaggregation of Revenue [Line Items]
Revenues	37	5,607	4,423	14,898
Other
Disaggregation of Revenue [Line Items]
Revenues	614	23	(586)	156
Product Revenue
Disaggregation of Revenue [Line Items]
Revenues	$ 73,229	$ 83,784	$ 190,702	$ 236,831

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Revenue Recognition - Total Gross Product Sales Offset by Product Sales Allowance and Accruals (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Provision for product sales allowances and accruals:
Revenues	$ 93,106	$ 83,808	$ 210,637	$ 237,062
Product Revenue
Disaggregation of Revenue [Line Items]
Gross product sales	218,739	254,073	633,475	704,976
Provision for product sales allowances and accruals:
Contractual adjustments	129,966	144,108	383,003	381,633
Governmental rebates	15,544	26,181	59,770	86,512
Total	145,510	170,289	442,773	468,145
Revenues	$ 73,229	$ 83,784	$ 190,702	$ 236,831

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Revenue Recognition - Product Revenue Allowance and Accrual Activity (Details) - USD ($) $ in Thousands	3 Months Ended
	Sep. 30, 2020	Jun. 30, 2020	Mar. 31, 2020
Contractual Adjustments
Balance at Beginning of Period	$ 83,712	$ 105,143	$ 95,221
Provisions related to current period sales	129,402	111,508	147,235
Adjustments related to prior period sales	565	(634)	(4,060)
Payments/returns relating to current period sales	(115,634)	(112,821)	(95,284)
Payments/returns relating to prior period sales	(5,803)	(19,484)	(37,969)
Balance at End of Period	92,242	83,712	105,143
Governmental Rebates
Balance at Beginning of Period	38,064	39,935	47,623
Provisions related to current period sales	17,410	21,904	20,982
Adjustments related to prior period sales	(1,867)	378	976
Payments/returns relating to current period sales	(14,259)	(13,913)	0
Payments/returns relating to prior period sales	(830)	(10,240)	(29,646)
Balance at End of Period	38,518	38,064	39,935
Total
Balance at Beginning of Period	121,776	145,078	142,844
Provisions related to current period sales	146,812	133,412	168,217
Adjustments related to prior period sales	(1,302)	(256)	(3,084)
Payments/returns relating to current period sales	(129,893)	(126,734)	(95,284)
Payments/returns relating to prior period sales	(6,633)	(29,724)	(67,615)
Balance at End of Period	$ 130,760	$ 121,776	$ 145,078

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Revenue Recognition - Narrative (Details) $ in Thousands	1 Months Ended	3 Months Ended		9 Months Ended
	Jul. 31, 2020 USD ($)	Sep. 30, 2020 USD ($)	Sep. 30, 2019 USD ($)	Sep. 30, 2020 USD ($)	Sep. 30, 2019 USD ($)	Dec. 31, 2019 USD ($)
Disaggregation of Revenue [Line Items]
Revenues		$ 93,106	$ 83,808	$ 210,637	$ 237,062
Current portion of deferred revenue		2,477		2,477		$ 0
Norgine B.V. | Ciraparantag
Disaggregation of Revenue [Line Items]
Proceeds related to collaborative arrangement	$ 30,000
Recovery of direct costs	33.00%
Potential milestone proceeds from collaborative arrangement payable to equity holders	$ 40,000
Incurred contract acquisition costs		2,000		2,000
Incurred contract acquisition costs amortized				1,300
Incurred contract acquisition costs deferred		700		700
Norgine B.V. | Ciraparantag | Maximum | Regulatory Milestone Achievement
Disaggregation of Revenue [Line Items]
Potential milestone proceeds from collaborative arrangement	70,000
Norgine B.V. | Ciraparantag | Maximum | Sales Milestones Achievement
Disaggregation of Revenue [Line Items]
Potential milestone proceeds from collaborative arrangement	190,000
Norgine B.V. | License Rights
Disaggregation of Revenue [Line Items]
Revenues	$ 19,800
Norgine B.V. | License Rights | Valuation Technique, Discounted Cash Flow | Measurement Input, Discount Rate
Disaggregation of Revenue [Line Items]
Revenue, performance obligation, measurement input	0.27
Norgine B.V. | Research And Development Services
Disaggregation of Revenue [Line Items]
Revenues, remaining performance obligation, amount	$ 10,200
Norgine B.V. | Development Services
Disaggregation of Revenue [Line Items]
Deferred revenue		10,200		10,200
Current portion of deferred revenue		$ 2,500		$ 2,500

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Marketable Securities - Summary of Marketable Securities (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Securities maturing within one year:
Amortized Cost	$ 47,649	$ 50,436
Gross Unrealized Gains	145	140
Gross Unrealized Losses	(1)	(2)
Estimated Fair Value	47,793	50,574
Securities maturing between one and three years:
Amortized Cost	22,807	8,016
Gross Unrealized Gains	319	152
Gross Unrealized Losses	(2)	0
Estimated Fair Value	23,124	8,168
Total marketable securities
Amortized Cost	70,456	58,452
Gross Unrealized Gains	464	292
Gross Unrealized Losses	(3)	(2)
Estimated Fair Value	70,917	58,742
Corporate debt securities
Securities maturing within one year:
Amortized Cost	23,861	46,186
Gross Unrealized Gains	145	140
Gross Unrealized Losses	(1)	(2)
Estimated Fair Value	24,005	46,324
Securities maturing between one and three years:
Amortized Cost	16,809	8,016
Gross Unrealized Gains	319	152
Gross Unrealized Losses	(2)	0
Estimated Fair Value	17,126	8,168
U.S. treasury and government agency securities
Securities maturing within one year:
Amortized Cost		2,750
Gross Unrealized Gains		0
Gross Unrealized Losses		0
Estimated Fair Value		2,750
Securities maturing between one and three years:
Amortized Cost	4,998
Gross Unrealized Gains	0
Gross Unrealized Losses	0
Estimated Fair Value	4,998
Certificates of deposit
Securities maturing within one year:
Amortized Cost	14,300	1,500
Gross Unrealized Gains	0	0
Gross Unrealized Losses	0	0
Estimated Fair Value	14,300	$ 1,500
Securities maturing between one and three years:
Amortized Cost	1,000
Gross Unrealized Gains	0
Gross Unrealized Losses	0
Estimated Fair Value	1,000
Commercial paper
Securities maturing within one year:
Amortized Cost	9,488
Gross Unrealized Gains	0
Gross Unrealized Losses	0
Estimated Fair Value	$ 9,488

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Fair Value Measurements - Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - Fair Value, Recurring - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Assets:
Cash equivalents	$ 2,750	$ 13,732
Total assets	73,667	72,474
Liabilities:
Total liabilities		17
Contingent consideration - MuGard
Liabilities:
Contingent consideration - MuGard		17
Quoted Prices in Active Markets for Identical Assets (Level 1)
Assets:
Cash equivalents	2,750	13,732
Total assets	2,750	13,732
Liabilities:
Total liabilities		0
Quoted Prices in Active Markets for Identical Assets (Level 1) | Contingent consideration - MuGard
Liabilities:
Contingent consideration - MuGard		0
Significant Other Observable Inputs (Level 2)
Assets:
Cash equivalents	0	0
Total assets	70,917	58,742
Liabilities:
Total liabilities		0
Significant Other Observable Inputs (Level 2) | Contingent consideration - MuGard
Liabilities:
Contingent consideration - MuGard		0
Significant Unobservable Inputs (Level 3)
Assets:
Cash equivalents	0	0
Total assets	0	0
Liabilities:
Total liabilities		17
Significant Unobservable Inputs (Level 3) | Contingent consideration - MuGard
Liabilities:
Contingent consideration - MuGard		17
Corporate debt securities
Assets:
Marketable securities	41,131	54,492
Corporate debt securities | Quoted Prices in Active Markets for Identical Assets (Level 1)
Assets:
Marketable securities	0	0
Corporate debt securities | Significant Other Observable Inputs (Level 2)
Assets:
Marketable securities	41,131	54,492
Corporate debt securities | Significant Unobservable Inputs (Level 3)
Assets:
Marketable securities	0	0
U.S. treasury and government agency securities
Assets:
Marketable securities	4,998	2,750
U.S. treasury and government agency securities | Quoted Prices in Active Markets for Identical Assets (Level 1)
Assets:
Marketable securities		0
U.S. treasury and government agency securities | Significant Other Observable Inputs (Level 2)
Assets:
Marketable securities	4,998	2,750
U.S. treasury and government agency securities | Significant Unobservable Inputs (Level 3)
Assets:
Marketable securities	0	0
Certificates of deposit
Assets:
Marketable securities	15,300	1,500
Certificates of deposit | Quoted Prices in Active Markets for Identical Assets (Level 1)
Assets:
Marketable securities	0	0
Certificates of deposit | Significant Other Observable Inputs (Level 2)
Assets:
Marketable securities	15,300	1,500
Certificates of deposit | Significant Unobservable Inputs (Level 3)
Assets:
Marketable securities	0	$ 0
Commercial paper
Assets:
Marketable securities	9,488
Commercial paper | Quoted Prices in Active Markets for Identical Assets (Level 1)
Assets:
Marketable securities
Commercial paper | Significant Other Observable Inputs (Level 2)
Assets:
Marketable securities	9,488
Commercial paper | Significant Unobservable Inputs (Level 3)
Assets:
Marketable securities	$ 0

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Fair Value Measurements - Narrative (Details) $ in Millions	Sep. 30, 2020 USD ($)
Senior Convertible Notes Due 2022 | Significant Other Observable Inputs (Level 2)
Debt
Fair value of debt	$ 289.7

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Inventories (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Inventory Disclosure [Abstract]
Raw materials	$ 3,424	$ 5,211
Work in process	6,495	6,248
Finished goods	12,987	20,094
Total inventories	$ 22,906	$ 31,553

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Property and Equipment, Net (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Property, plant and equipment, net
Property and equipment, gross	$ 14,909	$ 15,492
Less: accumulated depreciation	(12,494)	(11,376)
Property and equipment, net	2,415	4,116
Computer equipment and software
Property, plant and equipment, net
Property and equipment, gross	1,568	1,568
Furniture and fixtures
Property, plant and equipment, net
Property and equipment, gross	1,714	1,714
Leasehold improvements
Property, plant and equipment, net
Property and equipment, gross	4,985	4,984
Laboratory and production equipment
Property, plant and equipment, net
Property and equipment, gross	6,281	6,570
Construction in progress
Property, plant and equipment, net
Property and equipment, gross	$ 361	$ 656

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Goodwill and Intangible Assets, Net - Intangible Assets (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Amortizable intangible assets:
Cost	$ 79,100	$ 216,755
Accumulated amortization	21,701	41,844
Cumulative impairments	55,426	151,291
Net	1,973	23,620
Makena auto-injector developed technology | Developed Technology Rights
Amortizable intangible assets:
Cost	79,100	79,100
Accumulated amortization	21,701	15,782
Cumulative impairments	55,426	55,426
Net	1,973	7,892
Intrarosa developed technology | Developed Technology Rights
Amortizable intangible assets:
Cost	0	77,655
Accumulated amortization	0	16,798
Cumulative impairments	0	56,881
Net	0	3,976
Vyleesi developed technology | Developed Technology Rights
Amortizable intangible assets:
Cost	0	60,000
Accumulated amortization	0	9,264
Cumulative impairments	0	38,984
Net	$ 0	$ 11,752

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Goodwill and Intangible Assets, Net - Narrative (Details) - USD ($)	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Goodwill and Intangible Assets Disclosure [Abstract]
Accumulated impairment loss related to goodwill	$ 0
Weighted average remaining amortization period for finite-lived intangible assets	1 year
Amortization of finite-lived intangible assets	$ 20,800,000	$ 12,100,000

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Current Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Payables and Accruals [Abstract]
Commercial rebates, fees and returns	$ 106,367	$ 124,730
Manufacturing costs	8,778	21,364
Salaries, bonuses, and other compensation	13,121	18,693
Professional, license, and other fees and expenses	12,403	13,392
Research and development expense	865	3,539
Interest expense	3,467	867
Restructuring expense	1,596	797
Total accrued expenses	$ 146,597	$ 183,382

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Income Taxes - Effective Income Tax Rate and Income Tax Expense (Benefit) (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Income Tax Disclosure [Abstract]
Effective tax rate	(1.00%)	(1.00%)	0.00%	0.00%
Income tax (benefit) expense	$ (53)	$ 232	$ (113)	$ (26)

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Income Taxes - Narrative (Details)	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Income Tax Disclosure [Abstract]
Effective tax rate	(1.00%)	(1.00%)	0.00%	0.00%

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Earnings Per Share - Components of Basic and Diluted Earnings Per Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Earnings Per Share [Abstract]
Net income (loss)	$ 9,702	$ (23,940)	$ (31,466)	$ (267,509)
Weighted average common shares outstanding (in shares)	34,484	33,906	34,314	34,058
Effect of dilutive securities:
Stock options and RSUs	236	0	0	0
Shares used in calculating dilutive net income (loss) per share (in shares)	34,720	33,906	34,314	34,058
Net income (loss) per share:
Basic (in dollars per share)	$ 0.28	$ (0.71)	$ (0.92)	$ (7.85)
Diluted (in dollars per share)	$ 0.28	$ (0.71)	$ (0.92)	$ (7.85)

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Earnings Per Share - Anti-Dilutive Securities from Computation of Diluted Net Income (Loss) Per Share (Details) - shares shares in Thousands	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive securities (in shares)	16,963	17,328
Options to purchase shares of common stock
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive securities (in shares)	4,233	3,988
Shares of common stock issuable upon the vesting of RSUs
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive securities (in shares)	1,035	1,645
2022 Convertible Notes
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Anti-dilutive securities (in shares)	11,695	11,695

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Equity-Based Compensation - Narrative (Details) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020 USD ($)	Sep. 30, 2019 USD ($)	Sep. 30, 2020 USD ($) installment plan	Sep. 30, 2019 USD ($)
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of equity compensation plans | plan			3
Total equity-based compensation expense	$ 2,222	$ 4,974	$ 8,101	$ 13,716
Restructuring Charges
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Total equity-based compensation expense				$ 700
Inducement Grants
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of annual installments for exercising options | installment			4

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Equity-Based Compensation - Activity Related to Plans (Details)	9 Months Ended
	Sep. 30, 2020 shares
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward]
Outstanding, beginning (in shares)	3,885,817
Granted (in shares)	1,420,912
Exercised (in shares)	(19,937)
Expired or terminated (in shares)	(1,053,506)
Outstanding, ending (in shares)	4,233,286
Restricted Stock Units
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward]
Outstanding (in shares)	1,579,437
Granted (in shares)	825,131
Vested (in shares)	(550,635)
Expired or terminated (in shares)	(819,372)
Outstanding (in shares)	1,034,561
2019 Plan
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward]
Outstanding, beginning (in shares)	472,412
Granted (in shares)	420,912
Exercised (in shares)	(18,487)
Expired or terminated (in shares)	(149,863)
Outstanding, ending (in shares)	724,974
2019 Plan | Restricted Stock Units
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward]
Outstanding (in shares)	128,742
Granted (in shares)	825,131
Vested (in shares)	(78,689)
Expired or terminated (in shares)	(209,697)
Outstanding (in shares)	665,487
2007 Plan
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward]
Outstanding, beginning (in shares)	2,585,466
Granted (in shares)	0
Exercised (in shares)	0
Expired or terminated (in shares)	(672,295)
Outstanding, ending (in shares)	1,913,171
2007 Plan | Restricted Stock Units
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward]
Outstanding (in shares)	1,407,305
Granted (in shares)	0
Vested (in shares)	(460,185)
Expired or terminated (in shares)	(591,972)
Outstanding (in shares)	355,148
Lumara Health 2013 Plan
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward]
Outstanding, beginning (in shares)	131,775
Granted (in shares)	0
Exercised (in shares)	(1,450)
Expired or terminated (in shares)	(43,250)
Outstanding, ending (in shares)	87,075
Lumara Health 2013 Plan | Restricted Stock Units
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward]
Outstanding (in shares)	2,167
Granted (in shares)	0
Vested (in shares)	(899)
Expired or terminated (in shares)	(534)
Outstanding (in shares)	734
Inducement Grants
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward]
Outstanding, beginning (in shares)	696,164
Granted (in shares)	1,000,000
Exercised (in shares)	0
Expired or terminated (in shares)	(188,098)
Outstanding, ending (in shares)	1,508,066
Inducement Grants | Restricted Stock Units
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward]
Outstanding (in shares)	41,223
Granted (in shares)	0
Vested (in shares)	(10,862)
Expired or terminated (in shares)	(17,169)
Outstanding (in shares)	13,192

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Equity-Based Compensation - Equity-Based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total equity-based compensation expense	$ 2,222	$ 4,974	$ 8,101	$ 13,716
Income tax effect	0	0	0	0
After-tax effect of equity-based compensation expense	2,222	4,974	8,101	13,716
Cost of product sales
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total equity-based compensation expense	131	225	438	626
Research and development
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total equity-based compensation expense	237	691	260	2,051
Selling, general and administrative
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Total equity-based compensation expense	$ 1,854	$ 4,058	$ 7,403	$ 11,039

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Stockholders' Equity (Details) - USD ($)	9 Months Ended
	Sep. 30, 2020	Jan. 01, 2020	Mar. 31, 2019
Equity [Abstract]
Share repurchase program, remaining authorized amount	$ 26,800,000	$ 26,800,000
Share repurchase program, authorized amount			$ 80,000,000.0
Common stock repurchased and retired (in shares)	0

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Commitments and Contingencies - Narrative (Details) $ in Thousands			3 Months Ended		9 Months Ended
	Nov. 06, 2019 defendant	Sep. 25, 2019 USD ($)	Sep. 30, 2020 USD ($)	Sep. 30, 2019 USD ($)	Sep. 30, 2020 USD ($)	Sep. 30, 2019 USD ($)	Dec. 31, 2019 USD ($)
Loss Contingencies [Line Items]
Operating lease, liability			$ 21,887		$ 21,887
Operating lease, right-of-use asset			$ 21,063		$ 21,063		$ 23,286
Weighted average remaining operating lease term			7 years 4 months 24 days		7 years 4 months 24 days
Weighted average operating lease discount rate			5.10%		5.10%
Lease cost			$ 1,200	$ 1,400	$ 3,800	$ 3,900
Operating cash outflows from operating leases					3,600	$ 4,200
Minimum purchase commitments			$ 25,900		$ 25,900
Amount of damages sought after by plaintiff		$ 50,000
Civil Case In Saginaw Chippewa Indian Tribe V. Purdue Pharma Et Al | Pending Litigation
Loss Contingencies [Line Items]
Number of other pharmaceutical companies named as defendants | defendant	40
Minimum
Loss Contingencies [Line Items]
Remaining operating lease term			1 year		1 year
Maximum
Loss Contingencies [Line Items]
Remaining operating lease term			8 years		8 years

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Commitments and Contingencies - Future Minimum Payments under Non-Cancelable Operating Leases (Details) $ in Thousands	Sep. 30, 2020 USD ($)
Commitments and Contingencies Disclosure [Abstract]
Remainder of Year Ending December 31, 2020	$ 947
Year Ending December 31, 2021	3,248
Year Ending December 31, 2022	3,887
Year Ending December 31, 2023	3,291
Year Ending December 31, 2024	3,246
Thereafter	12,192
Total	26,811
Less: Interest	(4,924)
Operating lease liability	$ 21,887

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Acquisitions, Collaboration, License and Other Strategic Agreements - Narrative (Details) $ in Thousands					1 Months Ended		3 Months Ended		9 Months Ended
	Mar. 31, 2021 USD ($)	Aug. 06, 2020 USD ($)	May 21, 2020 USD ($) day	Jan. 16, 2019 USD ($)	Jul. 31, 2020 USD ($)	Sep. 30, 2018 USD ($)	Sep. 30, 2020 USD ($)	Sep. 30, 2019 USD ($)	Sep. 30, 2020 USD ($)	Sep. 30, 2019 USD ($)
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Agreement termination payment		$ 12,500
Option period to third party supplier to acquire study		9 months
Loss on disposal of assets, net							$ 35,400	$ 0	$ 20,956	$ 0
Velo Bio, LLC | Regulatory Milestone Achievement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payments						$ 5,000
Velo Bio, LLC | Regulatory Milestone Achievement, U.S.Food And Drug Administration Approval
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payments						30,000
Velo Bio, LLC | Annual Sales Milestone Achievements
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payments						240,000
Velo Bio, LLC | Annual Sales Milestone Achievements | Maximum
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Sales milestone targets						900,000
Velo Bio, LLC | Annual Sales Milestone Achievements | Minimum
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Sales milestone targets						300,000
Velo Bio, LLC | Commercial Milestone Payments
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Milestone payments						$ 10,000
Ciraparantag | Norgine B.V.
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Proceeds related to collaborative arrangement					$ 30,000
Potential milestone proceeds from collaborative arrangement payable to equity holders					40,000
Ciraparantag | Norgine B.V. | Regulatory Milestone Achievement | Maximum
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Potential milestone proceeds from collaborative arrangement					70,000
Ciraparantag | Norgine B.V. | Sales Milestones Achievement | Maximum
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Potential milestone proceeds from collaborative arrangement					190,000
Intrarosa | Millicent Pharma Limited
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Proceeds related to collaborative arrangement			$ 20,900
Loss on disposal of assets, net							(14,400)		(14,400)
Intrarosa | Millicent Pharma Limited | Collaborative Arrangement, Transaction With Party To Collaborative Arrangement, Transaction Fees
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Payments related to collaborative arrangement									2,500
Intrarosa | Millicent Pharma Limited | Collaborative Arrangement, Transaction With Party To Collaborative Arrangement, Carrying Value Of Assets Sold And Other Costs
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Payments related to collaborative arrangement									4,000
Intrarosa | Millicent Pharma Limited | Maximum
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Potential milestone proceeds from collaborative arrangement			105,000
Intrarosa | Millicent Pharma Limited | First Time Net Sales During Threshold Period Exceeds $65 Million
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Potential milestone proceeds from collaborative arrangement			$ 25,000
Consecutive period for sales to exceed threshold amount for potential milestone proceeds (in days) | day			12
Potential milestone proceeds, triggering event, sales			$ 65,000
Intrarosa | Millicent Pharma Limited | First Time Net Sales During Threshold Period Exceeds $115 Million
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Potential milestone proceeds from collaborative arrangement			$ 35,000
Consecutive period for sales to exceed threshold amount for potential milestone proceeds (in days) | day			12
Potential milestone proceeds, triggering event, sales			$ 115,000
Intrarosa | Millicent Pharma Limited | First Time Net Sales During Threshold Period Exceeds $175 Million
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Potential milestone proceeds from collaborative arrangement			$ 45,000
Consecutive period for sales to exceed threshold amount for potential milestone proceeds (in days) | day			12
Potential milestone proceeds, triggering event, sales			$ 175,000
Vyleesi Products | Palatin Technologies, Inc.
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Loss on disposal of assets, net							$ 22,400		22,400
Early contract termination fees					$ 12,000
Assets and other costs carrying value, recognized in loss of disposal of assets									$ 6,100
Vyleesi Products | Palatin Technologies, Inc. | Subsequent Event | Forecast
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Early contract termination fees	$ 4,300
Perosphere Pharmaceuticals Inc.
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Contingent consideration (up to)				$ 365,000
Perosphere Pharmaceuticals Inc. | Regulatory Milestone Achievement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Contingent consideration (up to)				$ 140,000
Credited percentage				50.00%
Perosphere Pharmaceuticals Inc. | Sales Milestones Achievement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Contingent consideration (up to)				$ 225,000
Perosphere Pharmaceuticals Inc. | Milestone Achievement, Approval by European Medicines Agency
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Contingent consideration (up to)				40,000
Perosphere Pharmaceuticals Inc. | First Sales Milestone Achievement
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]
Contingent consideration, milestone payment				20,000
Potential milestone payment, triggering event, sales				$ 100,000

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Debt - Outstanding Debt Obligations (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Debt Instrument [Line Items]
Total long-term debt	$ 289,334	$ 277,034
Less: current maturities	0	0
Long-term debt, net of current maturities	289,334	277,034
Convertible Debt | 2022 Convertible Notes
Debt Instrument [Line Items]
Total long-term debt	$ 289,334	$ 277,034

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Debt - Outstanding Convertible Debt (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Liability component:
Total long-term debt	$ 289,334	$ 277,034
Convertible Debt | 2022 Convertible Notes
Liability component:
Principal	320,000
Less: debt discount and issuance costs, net	30,666
Total long-term debt	289,334	$ 277,034
Gross equity component	$ 72,576

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Debt - Narrative (Details)		3 Months Ended	9 Months Ended
	Feb. 15, 2019 USD ($)	Jun. 30, 2017 USD ($) day $ / shares	Sep. 30, 2020 USD ($)	Sep. 30, 2019 USD ($)	Dec. 31, 2017 USD ($)	Feb. 28, 2014 USD ($)
Debt Instrument [Line Items]
Extinguishment of debt			$ 0	$ 21,417,000
Future annual principal payments on long-term debt due during the year ending December 31, 2022			$ 320,000,000.0
Convertible Notes due 2022 | Convertible Debt
Debt Instrument [Line Items]
Period of amortization of debt discount to interest expense using effective interest method		5 years	5 years
Aggregate principal amount of debt issued		$ 320,000,000.0
Proceeds from 2022 Convertible Notes		310,400,000
Payment of convertible debt issuance costs		9,600,000
Debt issuance costs		9,600,000
Debt issuance costs, allocated to equity component		2,200,000
Debt issuance costs allocated to the liability component		$ 7,400,000
Interest rate		3.25%
Debt conversion ratio		0.0365464
Initial conversion price of convertible notes into common stock (in dollars per share) | $ / shares		$ 27.36
Debt term		5 years
Effective interest rate on liability component			9.49%
Convertible Notes due 2019 | Convertible Debt
Debt Instrument [Line Items]
Aggregate principal amount of debt issued						$ 200,000,000.0
Repurchase amount					$ 178,500,000
Repurchase price					$ 192,700,000
Extinguishment of debt	$ 21,400,000
Debt Instrument, Conversion, Period One | Convertible Notes due 2022 | Convertible Debt
Debt Instrument [Line Items]
Trading period | day		20
Consecutive trading period (in days) | day		30
Closing sales price of the entity's common stock that the conversion price must exceed or be equal in order for the notes to be convertible		130.00%
Debt Instrument, Conversion, Period Two | Convertible Notes due 2022 | Convertible Debt
Debt Instrument [Line Items]
Consecutive trading period (in days) | day		5
Closing sales price of the entity's common stock that the conversion price must exceed or be equal in order for the notes to be convertible		98.00%
Consecutive business days after any five consecutive trading day period during the note measurement period | day		5

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Debt - Total Interest Expense Recognized Related to the Convertible Debt (Details) - Convertible Debt - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Debt Instrument [Line Items]
Contractual interest expense	$ 2,600	$ 2,600	$ 7,800	$ 7,867
Amortization of debt issuance costs	388	353	1,137	1,051
Amortization of debt discount	3,810	3,466	11,164	10,281
Total interest expense	$ 6,798	$ 6,419	$ 20,101	$ 19,199

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Restructuring Expenses - Narrative (Details) $ in Thousands	1 Months Ended		3 Months Ended				9 Months Ended
	May 30, 2020 employee	Feb. 28, 2019 employee	Sep. 30, 2020 USD ($)	Jun. 30, 2020 USD ($)	Sep. 30, 2019 USD ($)	Mar. 31, 2019 USD ($)	Sep. 30, 2020 USD ($)	Sep. 30, 2019 USD ($)
Restructuring and Related Activities [Abstract]
Number of employees displaced through workforce reduction | employee	110	110
Restructuring charges | $			$ 0	$ 8,200	$ 0	$ 7,400	$ 8,197	$ 7,420

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Restructuring Expenses - Restructuring Charges (Details) - USD ($) $ in Thousands	3 Months Ended				9 Months Ended
	Sep. 30, 2020	Jun. 30, 2020	Sep. 30, 2019	Mar. 31, 2019	Sep. 30, 2020	Sep. 30, 2019
2020 Restructuring charges:
Workforce reduction					$ 8,090
Other					107
Total 2020 restructuring charges	$ 0	$ 8,200	$ 0	$ 7,400	$ 8,197	$ 7,420

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Restructuring Expenses - Changes to Restructuring Charges (Details) - USD ($) $ in Thousands	3 Months Ended				9 Months Ended
	Sep. 30, 2020	Jun. 30, 2020	Sep. 30, 2019	Mar. 31, 2019	Sep. 30, 2020	Sep. 30, 2019
Restructuring Reserve [Roll Forward]
Balance accrued at December 31, 2019					$ 797
Restructuring charges	$ 0	$ 8,200	$ 0	$ 7,400	8,197	$ 7,420
Balance accrued at September 30, 2020	1,596				1,596
2019 Restructuring
Restructuring Reserve [Roll Forward]
Balance accrued at December 31, 2019					797
Restructuring charges					0
Balance accrued at September 30, 2020	171				171
2020 Restructuring
Restructuring Reserve [Roll Forward]
Balance accrued at December 31, 2019					0
Restructuring charges					8,197
Balance accrued at September 30, 2020	$ 1,425				1,425
Workforce Reduction Payments
Restructuring Reserve [Roll Forward]
Payments for restructuring					(7,291)
Workforce Reduction Payments | 2019 Restructuring
Restructuring Reserve [Roll Forward]
Payments for restructuring					(626)
Workforce Reduction Payments | 2020 Restructuring
Restructuring Reserve [Roll Forward]
Payments for restructuring					(6,665)
Other Payments
Restructuring Reserve [Roll Forward]
Payments for restructuring					(107)
Other Payments | 2019 Restructuring
Restructuring Reserve [Roll Forward]
Payments for restructuring					0
Other Payments | 2020 Restructuring
Restructuring Reserve [Roll Forward]
Payments for restructuring					$ (107)

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Revision of Prior Period Financial Statements - Narrative (Details) - USD ($) $ in Thousands	3 Months Ended				9 Months Ended		48 Months Ended	51 Months Ended
	Sep. 30, 2020	Jun. 30, 2020	Mar. 31, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019	Dec. 31, 2019	Mar. 31, 2020	Jul. 01, 2020	Jan. 01, 2019
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Royalty obligation	$ 13,340			$ 21,105	$ 55,426	$ 63,871
Increase to accumulated deficit	$ 1,046,667	$ 1,056,369			$ 1,046,667		$ 1,015,201
Revision of Prior Period, Error Correction, Adjustment
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Governmental rebates		(2,800)					$ (6,300)	$ (6,300)
Royalty obligation		200	$ 200
Increase to accumulated deficit		$ 5,216							$ 5,200	$ 5,100
Revision of Prior Period, Error Correction, Adjustment | Revision Period One
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Governmental rebates			1,800
Revision of Prior Period, Error Correction, Adjustment | Revision Period Two
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Governmental rebates			$ (2,800)

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Revision of Prior Period Financial Statements - Condensed Consolidated Statement of Stockholders’ Equity (Details) - USD ($) $ in Thousands	Sep. 30, 2020	Jul. 01, 2020	Jun. 30, 2020	Dec. 31, 2019	Sep. 30, 2019	Jun. 30, 2019	Jan. 01, 2019	Dec. 31, 2018
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Accumulated deficit	$ (1,046,667)		$ (1,056,369)	$ (1,015,201)
Total stockholders' equity	$ 256,022		244,106	$ 279,816	$ 474,549	$ 493,751		$ 741,557
As reported
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Accumulated deficit			(1,051,153)
Total stockholders' equity			249,322
Adjustment
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Accumulated deficit		$ (5,200)	(5,216)				$ (5,100)
Total stockholders' equity			$ (5,216)

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Revision of Prior Period Financial Statements - Condensed Consolidated Statements of Operations (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Revenues	$ 93,106	$ 83,808	$ 210,637	$ 237,062
Net loss	9,702	$ (23,940)	(31,466)	$ (267,509)
Basic and diluted net income (loss) per share (in dollars per share)		$ (0.71)		$ (7.85)
As reported
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Revenues		$ 84,131		$ 238,043
Net loss		$ (23,617)		$ (266,528)
Basic and diluted net income (loss) per share (in dollars per share)		$ (0.70)		$ (7.83)
Adjustment
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Revenues		$ (323)		$ (981)
Net loss		$ (323)		$ (981)
Basic and diluted net income (loss) per share (in dollars per share)		$ (0.01)		$ (0.02)
Product Revenue
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Revenues	$ 73,229	$ 83,784	$ 190,702	$ 236,831
Product Revenue | As reported
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Revenues		84,107		237,812
Product Revenue | Adjustment
Error Corrections and Prior Period Adjustments Restatement [Line Items]
Revenues		$ (323)		$ (981)

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Subsequent Events (Details) - Subsequent Event $ / shares in Units, $ in Thousands	Oct. 01, 2020 USD ($) claim $ / shares
Pending Litigation | Securities Litigation Merger
Subsequent Event [Line Items]
Number of new claims filed | claim	7
Covis Group S.à r.l.
Subsequent Event [Line Items]
Contract termination fee | $	$ 16,250
AMAG Pharmaceuticals, Inc. | Covis Group S.à r.l.
Subsequent Event [Line Items]
Offer period (minimum)	20 days
Share price (in dollars per share) | $ / shares	$ 13.75