(Mark One)
|
|
☒
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the quarterly period ended March 31, 2018
|
|
or
|
|
☐
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the transition period from to
|
Delaware
(State or Other Jurisdiction of
Incorporation or Organization)
|
04-2742593
(I.R.S. Employer
Identification No.)
|
1100 Winter Street
Waltham, Massachusetts
(Address of Principal Executive Offices)
|
02451
(Zip Code)
|
Large accelerated filer
|
☒
|
|
Accelerated filer
|
☐
|
Non-accelerated filer
|
☐
|
(Do not check if a smaller reporting company)
|
Smaller reporting company
|
☐
|
|
|
|
Emerging growth company
|
☐
|
|
||
|
||
|
|
|
|
||
|
||
|
|
|
|
|
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
|
|
||
Cash and cash equivalents
|
$
|
231,737
|
|
|
$
|
192,114
|
|
Marketable securities
|
138,820
|
|
|
136,593
|
|
||
Accounts receivable, net
|
99,945
|
|
|
103,501
|
|
||
Inventories
|
31,598
|
|
|
37,356
|
|
||
Prepaid and other current assets
|
16,345
|
|
|
12,304
|
|
||
Total current assets
|
518,445
|
|
|
481,868
|
|
||
Property, plant and equipment, net
|
25,921
|
|
|
25,996
|
|
||
Goodwill
|
639,484
|
|
|
639,484
|
|
||
Intangible assets, net
|
648,206
|
|
|
704,470
|
|
||
Restricted cash
|
656
|
|
|
656
|
|
||
Other long-term assets
|
2,238
|
|
|
762
|
|
||
Total assets
|
$
|
1,834,950
|
|
|
$
|
1,853,236
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable
|
$
|
17,371
|
|
|
$
|
10,335
|
|
Accrued expenses
|
199,071
|
|
|
175,490
|
|
||
Current portion of convertible notes, net
|
20,460
|
|
|
—
|
|
||
Current portion of acquisition-related contingent consideration
|
50,007
|
|
|
49,399
|
|
||
Deferred revenues
|
42,510
|
|
|
42,494
|
|
||
Total current liabilities
|
329,419
|
|
|
277,718
|
|
||
Long-term liabilities:
|
|
|
|
|
|
||
Long-term debt, net
|
466,595
|
|
|
466,291
|
|
||
Convertible notes, net
|
251,508
|
|
|
268,392
|
|
||
Acquisition-related contingent consideration
|
660
|
|
|
686
|
|
||
Deferred tax liabilities
|
17,497
|
|
|
23,927
|
|
||
Deferred revenues
|
27,398
|
|
|
24,387
|
|
||
Other long-term liabilities
|
1,878
|
|
|
1,591
|
|
||
Total liabilities
|
1,094,955
|
|
|
1,062,992
|
|
||
Commitments and contingencies
|
|
|
|
|
|
||
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; 34,322,193 and 34,083,112 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively
|
343
|
|
|
341
|
|
||
Additional paid-in capital
|
1,274,935
|
|
|
1,271,628
|
|
||
Accumulated other comprehensive loss
|
(4,362
|
)
|
|
(3,908
|
)
|
||
Accumulated deficit
|
(530,921
|
)
|
|
(477,817
|
)
|
||
Total stockholders’ equity
|
739,995
|
|
|
790,244
|
|
||
Total liabilities and stockholders’ equity
|
$
|
1,834,950
|
|
|
$
|
1,853,236
|
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Revenues:
|
|
|
|
||||
Product sales, net
|
$
|
117,348
|
|
|
$
|
112,517
|
|
Service revenues, net
|
28,969
|
|
|
26,931
|
|
||
Other revenues
|
39
|
|
|
24
|
|
||
Total revenues
|
146,356
|
|
|
139,472
|
|
||
Costs and expenses:
|
|
|
|
||||
Cost of product sales
|
63,912
|
|
|
27,573
|
|
||
Cost of services
|
5,473
|
|
|
5,010
|
|
||
Research and development expenses
|
10,809
|
|
|
16,489
|
|
||
Acquired in-process research and development
|
20,000
|
|
|
60,000
|
|
||
Selling, general and administrative expenses
|
91,050
|
|
|
70,424
|
|
||
Total costs and expenses
|
191,244
|
|
|
179,496
|
|
||
Operating loss
|
(44,888
|
)
|
|
(40,024
|
)
|
||
Other (expense) income:
|
|
|
|
||||
Interest expense
|
(15,977
|
)
|
|
(18,300
|
)
|
||
Interest and dividend income
|
644
|
|
|
1,031
|
|
||
Gains on investments, net
|
—
|
|
|
27
|
|
||
Total other expense, net
|
(15,333
|
)
|
|
(17,242
|
)
|
||
Loss before income taxes
|
(60,221
|
)
|
|
(57,266
|
)
|
||
Income tax benefit
|
(5,979
|
)
|
|
(20,706
|
)
|
||
Net loss
|
$
|
(54,242
|
)
|
|
$
|
(36,560
|
)
|
Net loss per share:
|
|
|
|
||||
Basic and diluted
|
$
|
(1.59
|
)
|
|
$
|
(1.06
|
)
|
Weighted average shares outstanding used to compute net loss per share:
|
|
|
|
||||
Basic and diluted
|
34,162
|
|
|
34,378
|
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Net loss
|
$
|
(54,242
|
)
|
|
$
|
(36,560
|
)
|
Other comprehensive (loss) income:
|
|
|
|
||||
Holding (losses) gains arising during period, net of tax
|
(454
|
)
|
|
92
|
|
||
Total comprehensive loss
|
$
|
(54,696
|
)
|
|
$
|
(36,468
|
)
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Cash flows from operating activities:
|
|
|
|
||||
Net loss
|
$
|
(54,242
|
)
|
|
$
|
(36,560
|
)
|
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
|
|
|
|
||||
Depreciation and amortization
|
59,485
|
|
|
27,994
|
|
||
Provision for bad debt expense
|
463
|
|
|
590
|
|
||
Amortization of premium/discount on purchased securities
|
67
|
|
|
113
|
|
||
Non-cash equity-based compensation expense
|
5,533
|
|
|
5,778
|
|
||
Amortization of debt discount and debt issuance costs
|
3,880
|
|
|
3,209
|
|
||
Gains on marketable securities, net
|
—
|
|
|
(143
|
)
|
||
Change in fair value of contingent consideration
|
626
|
|
|
1,043
|
|
||
Deferred income taxes
|
(6,643
|
)
|
|
(21,192
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accounts receivable, net
|
3,093
|
|
|
6,553
|
|
||
Inventories
|
3,534
|
|
|
(403
|
)
|
||
Prepaid and other current assets
|
(3,720
|
)
|
|
1,523
|
|
||
Accounts payable and accrued expenses
|
30,374
|
|
|
(4,622
|
)
|
||
Deferred revenues
|
3,027
|
|
|
2,067
|
|
||
Other assets and liabilities
|
215
|
|
|
(486
|
)
|
||
Net cash provided by (used in) operating activities
|
45,692
|
|
|
(14,536
|
)
|
||
Cash flows from investing activities:
|
|
|
|
||||
Proceeds from sales or maturities of marketable securities
|
18,225
|
|
|
128,512
|
|
||
Purchase of marketable securities
|
(21,102
|
)
|
|
(129,241
|
)
|
||
Capital expenditures
|
(923
|
)
|
|
(658
|
)
|
||
Net cash used in investing activities
|
(3,800
|
)
|
|
(1,387
|
)
|
||
Cash flows from financing activities:
|
|
|
|
||||
Long-term debt principal payments
|
—
|
|
|
(4,375
|
)
|
||
Payments of contingent consideration
|
(44
|
)
|
|
(83
|
)
|
||
Proceeds from the exercise of common stock options
|
123
|
|
|
152
|
|
||
Payments of employee tax withholding related to equity-based compensation
|
(2,348
|
)
|
|
(1,322
|
)
|
||
Net cash used in financing activities
|
(2,269
|
)
|
|
(5,628
|
)
|
||
Net increase (decrease) in cash, cash equivalents, and restricted cash
|
39,623
|
|
|
(21,551
|
)
|
||
Cash, cash equivalents, and restricted cash at beginning of the period
|
192,770
|
|
|
276,898
|
|
||
Cash, cash equivalents, and restricted cash at end of the period
|
$
|
232,393
|
|
|
$
|
255,347
|
|
Supplemental data for cash flow information:
|
|
|
|
||||
Cash paid for taxes
|
$
|
136
|
|
|
$
|
208
|
|
Cash paid for interest
|
$
|
18,971
|
|
|
$
|
26,195
|
|
|
Three Months Ended March 31,
|
||||
|
2018
|
|
2017
|
||
AmerisourceBergen Drug Corporation
|
22
|
%
|
|
22
|
%
|
McKesson Corporation
|
22
|
%
|
|
14
|
%
|
|
March 31, 2018
|
|
December 31, 2017
|
||
McKesson Corporation
|
26
|
%
|
|
22
|
%
|
AmerisourceBergen Drug Corporation
|
24
|
%
|
|
27
|
%
|
Condensed Consolidated Balance Sheet
|
March 31, 2018
Impact of changes in accounting policies |
||||||||||
|
As Reported
|
|
Balances without adoption of
ASC 606 |
|
Impact of Adoption
|
||||||
Assets:
|
|
|
|
|
|
||||||
Prepaid and other current assets
|
$
|
16,345
|
|
|
$
|
16,248
|
|
|
$
|
97
|
|
Other long-term assets
|
$
|
2,238
|
|
|
$
|
538
|
|
|
$
|
1,700
|
|
Total assets
|
$
|
1,834,950
|
|
|
$
|
1,833,153
|
|
|
$
|
1,797
|
|
|
|
|
|
|
|
||||||
Liabilities and stockholders' equity:
|
|
|
|
|
|
||||||
Deferred tax liabilities
|
$
|
17,497
|
|
|
$
|
17,156
|
|
|
$
|
341
|
|
Accumulated deficit
|
$
|
(530,921
|
)
|
|
$
|
(532,377
|
)
|
|
$
|
1,456
|
|
Total liabilities and stockholders' equity
|
$
|
1,834,950
|
|
|
$
|
1,833,153
|
|
|
$
|
1,797
|
|
Condensed Consolidated Statement of Operations
|
March 31, 2018
Impact of changes in accounting policies |
||||||||||
|
As Reported
|
|
Balances without adoption of
ASC 606
|
|
Impact of Adoption
|
||||||
Costs and expenses:
|
|
|
|
|
|
||||||
Selling, general and administrative expenses
|
$
|
91,050
|
|
|
$
|
91,368
|
|
|
$
|
(318
|
)
|
Net loss
|
$
|
(54,242
|
)
|
|
$
|
(54,560
|
)
|
|
$
|
318
|
|
Condensed Consolidated Statement of Cash Flows
|
March 31, 2018
Impact of changes in accounting policies |
||||||||||
|
As Reported
|
|
Balances without adoption of
ASC 606
|
|
Impact of Adoption
|
||||||
Operating activities:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(54,242
|
)
|
|
$
|
(54,560
|
)
|
|
$
|
318
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Prepaid and other current assets
|
$
|
(3,720
|
)
|
|
$
|
(3,702
|
)
|
|
$
|
(18
|
)
|
Other assets and liabilities
|
$
|
215
|
|
|
$
|
515
|
|
|
$
|
(300
|
)
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Product sales, net
|
|
|
|
||||
Makena
|
$
|
89,983
|
|
|
$
|
86,455
|
|
Feraheme
|
25,135
|
|
|
25,922
|
|
||
Intrarosa
|
2,165
|
|
|
—
|
|
||
MuGard
|
65
|
|
|
140
|
|
||
Total
|
$
|
117,348
|
|
|
$
|
112,517
|
|
Service revenues, net
|
$
|
28,969
|
|
|
$
|
26,931
|
|
|
Three Months Ended March 31,
|
||||||||||||
|
2018
|
|
Percent of
gross product sales |
|
2017
|
|
Percent of
gross product sales |
||||||
Gross product sales
|
$
|
239,870
|
|
|
|
|
$
|
206,724
|
|
|
|
||
Provision for product sales allowances and accruals:
|
|
|
|
|
|
|
|
|
|
||||
Contractual adjustments
|
86,144
|
|
|
36
|
%
|
|
69,829
|
|
|
34
|
%
|
||
Governmental rebates
|
36,378
|
|
|
15
|
%
|
|
24,378
|
|
|
12
|
%
|
||
Total
|
122,522
|
|
|
51
|
%
|
|
94,207
|
|
|
46
|
%
|
||
Product sales, net
|
$
|
117,348
|
|
|
|
|
$
|
112,517
|
|
|
|
|
Contractual
|
|
Governmental
|
|
|
||||||
|
Adjustments
|
|
Rebates
|
|
Total
|
||||||
Balance at December 31, 2017
|
$
|
62,164
|
|
|
$
|
50,598
|
|
|
$
|
112,762
|
|
Provisions related to current period sales
|
85,308
|
|
|
31,028
|
|
|
116,336
|
|
|||
Adjustments related to prior period sales
|
836
|
|
|
5,350
|
|
|
6,186
|
|
|||
Payments/returns relating to current period sales
|
(44,633
|
)
|
|
—
|
|
|
(44,633
|
)
|
|||
Payments/returns relating to prior period sales
|
(39,441
|
)
|
|
(25,149
|
)
|
|
(64,590
|
)
|
|||
Balance at March 31, 2018
|
$
|
64,234
|
|
|
$
|
61,827
|
|
|
$
|
126,061
|
|
|
March 31, 2018
|
|
At Adoption
|
||||
Short-term contract assets (sales commissions)
|
$
|
97
|
|
|
$
|
79
|
|
Long-term contract assets (sales commissions)
|
$
|
1,700
|
|
|
$
|
1,400
|
|
Short-term contract liabilities (deferred revenue)
|
$
|
42,510
|
|
|
$
|
42,494
|
|
Long-term contract liabilities (deferred revenue)
|
$
|
27,398
|
|
|
$
|
24,387
|
|
|
Balance at January 1, 2018
|
|
Additions
|
|
Deductions
|
|
Balance at March 31, 2018
|
||||||||
Contract assets (sales commissions)
|
$
|
1,479
|
|
|
$
|
340
|
|
|
$
|
(22
|
)
|
|
$
|
1,797
|
|
Contract liabilities (deferred revenue)
|
$
|
66,881
|
|
|
$
|
21,727
|
|
|
$
|
(18,700
|
)
|
|
$
|
69,908
|
|
|
March 31, 2018
|
||||||||||||||
|
|
|
Gross
|
|
Gross
|
|
Estimated
|
||||||||
|
Amortized
|
|
Unrealized
|
|
Unrealized
|
|
Fair
|
||||||||
|
Cost
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Short-term marketable securities:*
|
|
|
|
|
|
|
|
||||||||
Corporate debt securities
|
$
|
58,981
|
|
|
$
|
—
|
|
|
$
|
(215
|
)
|
|
$
|
58,766
|
|
Certificates of deposit
|
10,150
|
|
|
—
|
|
|
—
|
|
|
10,150
|
|
||||
U.S. treasury and government agency securities
|
5,996
|
|
|
—
|
|
|
(57
|
)
|
|
5,939
|
|
||||
Commercial paper
|
5,962
|
|
|
—
|
|
|
—
|
|
|
5,962
|
|
||||
Total short-term marketable securities
|
$
|
81,089
|
|
|
$
|
—
|
|
|
$
|
(272
|
)
|
|
$
|
80,817
|
|
Long-term marketable securities:**
|
|
|
|
|
|
|
|
||||||||
Corporate debt securities
|
$
|
52,408
|
|
|
$
|
1
|
|
|
$
|
(725
|
)
|
|
$
|
51,684
|
|
U.S. treasury and government agency securities
|
6,381
|
|
|
—
|
|
|
(62
|
)
|
|
6,319
|
|
||||
Total long-term marketable securities
|
58,789
|
|
|
1
|
|
|
(787
|
)
|
|
58,003
|
|
||||
Total marketable securities
|
$
|
139,878
|
|
|
$
|
1
|
|
|
$
|
(1,059
|
)
|
|
$
|
138,820
|
|
|
December 31, 2017
|
||||||||||||||
|
|
|
Gross
|
|
Gross
|
|
Estimated
|
||||||||
|
Amortized
|
|
Unrealized
|
|
Unrealized
|
|
Fair
|
||||||||
|
Cost
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Short-term marketable securities:*
|
|
|
|
|
|
|
|
||||||||
Corporate debt securities
|
$
|
57,257
|
|
|
$
|
—
|
|
|
$
|
(68
|
)
|
|
57,189
|
|
|
Certificates of deposit
|
9,151
|
|
|
—
|
|
|
—
|
|
|
9,151
|
|
||||
U.S. treasury and government agency securities
|
1,999
|
|
|
—
|
|
|
(13
|
)
|
|
1,986
|
|
||||
Commercial paper
|
1,999
|
|
|
—
|
|
|
—
|
|
|
1,999
|
|
||||
Total short-term marketable securities
|
$
|
70,406
|
|
|
$
|
—
|
|
|
$
|
(81
|
)
|
|
$
|
70,325
|
|
Long-term marketable securities:**
|
|
|
|
|
|
|
|
||||||||
Corporate debt securities
|
$
|
59,282
|
|
|
$
|
1
|
|
|
$
|
(320
|
)
|
|
$
|
58,963
|
|
U.S. treasury and government agency securities
|
7,381
|
|
|
—
|
|
|
(76
|
)
|
|
7,305
|
|
||||
Total long-term marketable securities
|
66,663
|
|
|
1
|
|
|
(396
|
)
|
|
66,268
|
|
||||
Total marketable securities
|
$
|
137,069
|
|
|
$
|
1
|
|
|
$
|
(477
|
)
|
|
$
|
136,593
|
|
|
Fair Value Measurements at March 31, 2018 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
|
$
|
2,255
|
|
|
$
|
2,255
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Corporate debt securities
|
110,450
|
|
|
—
|
|
|
110,450
|
|
|
—
|
|
||||
U.S. treasury and government agency securities
|
12,258
|
|
|
—
|
|
|
12,258
|
|
|
—
|
|
||||
Certificates of deposit
|
10,150
|
|
|
|
|
10,150
|
|
|
—
|
|
|||||
Commercial paper
|
$
|
5,962
|
|
|
$
|
—
|
|
|
$
|
5,962
|
|
|
$
|
—
|
|
Total Assets
|
$
|
141,075
|
|
|
$
|
2,255
|
|
|
$
|
138,820
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Contingent consideration - Lumara Health
|
$
|
49,797
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
49,797
|
|
Contingent consideration - MuGard
|
870
|
|
|
—
|
|
|
—
|
|
|
870
|
|
||||
Total Liabilities
|
$
|
50,667
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
50,667
|
|
Balance as of December 31, 2017
|
$
|
50,085
|
|
Payments made
|
(44
|
)
|
|
Adjustments to fair value of contingent consideration
|
626
|
|
|
Balance as of March 31, 2018
|
$
|
50,667
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||
Raw materials
|
$
|
12,578
|
|
|
$
|
12,418
|
|
Work in process
|
5,417
|
|
|
4,146
|
|
||
Finished goods
|
13,603
|
|
|
20,792
|
|
||
Total inventories
|
$
|
31,598
|
|
|
$
|
37,356
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||
Land
|
$
|
700
|
|
|
$
|
700
|
|
Land improvements
|
300
|
|
|
300
|
|
||
Building and improvements
|
9,552
|
|
|
9,552
|
|
||
Computer equipment and software
|
14,072
|
|
|
14,073
|
|
||
Furniture and fixtures
|
2,513
|
|
|
2,512
|
|
||
Leasehold improvements
|
4,959
|
|
|
4,959
|
|
||
Laboratory and production equipment
|
13,286
|
|
|
8,030
|
|
||
Construction in progress
|
1,025
|
|
|
5,360
|
|
||
|
46,407
|
|
|
45,486
|
|
||
Less: accumulated depreciation
|
(20,486
|
)
|
|
(19,490
|
)
|
||
Property, plant and equipment, net
|
$
|
25,921
|
|
|
$
|
25,996
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||||||||||||||||||||||||||
|
|
|
Accumulated
|
|
Cumulative
|
|
|
|
|
|
Accumulated
|
|
Cumulative
|
|
|
||||||||||||||||
|
Cost
|
|
Amortization
|
|
Impairments
|
|
Net
|
|
Cost
|
|
Amortization
|
|
Impairments
|
|
Net
|
||||||||||||||||
Amortizable intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Makena base technology
|
$
|
797,100
|
|
|
$
|
306,242
|
|
|
$
|
319,246
|
|
|
$
|
171,612
|
|
|
$
|
797,100
|
|
|
$
|
255,754
|
|
|
$
|
319,246
|
|
|
$
|
222,100
|
|
CBR customer relationships
|
297,000
|
|
|
33,209
|
|
|
—
|
|
|
263,791
|
|
|
297,000
|
|
|
29,309
|
|
|
—
|
|
|
267,691
|
|
||||||||
Makena auto-injector developed technology
|
79,100
|
|
|
188
|
|
|
—
|
|
|
78,912
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Intrarosa developed technology
|
77,655
|
|
|
5,064
|
|
|
—
|
|
|
72,591
|
|
|
77,655
|
|
|
3,376
|
|
|
—
|
|
|
74,279
|
|
||||||||
|
1,250,855
|
|
|
344,703
|
|
|
319,246
|
|
|
586,906
|
|
|
1,171,755
|
|
|
288,439
|
|
|
319,246
|
|
|
564,070
|
|
||||||||
Indefinite-lived intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Makena IPR&D
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
79,100
|
|
|
—
|
|
|
—
|
|
|
79,100
|
|
||||||||
CBR trade names and trademarks
|
65,000
|
|
|
—
|
|
|
3,700
|
|
|
61,300
|
|
|
65,000
|
|
|
—
|
|
|
3,700
|
|
|
61,300
|
|
||||||||
Total intangible assets
|
$
|
1,315,855
|
|
|
$
|
344,703
|
|
|
$
|
322,946
|
|
|
$
|
648,206
|
|
|
$
|
1,315,855
|
|
|
$
|
288,439
|
|
|
$
|
322,946
|
|
|
$
|
704,470
|
|
|
|
Estimated
|
||
|
|
Amortization
|
||
Period
|
|
Expense
|
||
Remainder of Year Ending December 31, 2018
|
|
$
|
139,239
|
|
Year Ending December 31, 2019
|
|
48,552
|
|
|
Year Ending December 31, 2020
|
|
40,930
|
|
|
Year Ending December 31, 2021
|
|
40,718
|
|
|
Year Ending December 31, 2022
|
|
40,663
|
|
|
Thereafter
|
|
276,804
|
|
|
Total
|
|
$
|
586,906
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||
Commercial rebates, fees and returns
|
$
|
114,884
|
|
|
$
|
102,357
|
|
Professional, license, and other fees and expenses
|
29,033
|
|
|
28,692
|
|
||
Salaries, bonuses, and other compensation
|
14,034
|
|
|
19,099
|
|
||
Interest expense
|
6,639
|
|
|
13,525
|
|
||
Bremelanotide milestone payment
|
20,000
|
|
|
—
|
|
||
Intrarosa-related license fees
|
10,000
|
|
|
10,000
|
|
||
Accrued research and development
|
4,481
|
|
|
1,817
|
|
||
Total accrued expenses
|
$
|
199,071
|
|
|
$
|
175,490
|
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Beginning balance
|
$
|
(3,908
|
)
|
|
$
|
(3,838
|
)
|
Holding (losses) gains arising during period, net of tax
|
(454
|
)
|
|
92
|
|
||
Ending balance
|
$
|
(4,362
|
)
|
|
$
|
(3,746
|
)
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Net loss
|
$
|
(54,242
|
)
|
|
$
|
(36,560
|
)
|
Weighted average common shares outstanding
|
34,162
|
|
|
34,378
|
|
||
Shares used in calculating dilutive net loss per share
|
34,162
|
|
|
34,378
|
|
||
|
|
|
|
||||
Net loss per share:
|
|
|
|
|
|
||
Basic and diluted
|
$
|
(1.59
|
)
|
|
$
|
(1.06
|
)
|
|
Three Months Ended March 31,
|
||||
|
2018
|
|
2017
|
||
Options to purchase shares of common stock
|
3,771
|
|
|
2,406
|
|
Shares of common stock issuable upon the vesting of RSUs
|
1,401
|
|
|
775
|
|
Warrants
|
1,008
|
|
|
7,382
|
|
2022 Convertible Notes
|
11,695
|
|
|
—
|
|
2019 Convertible Notes
|
790
|
|
|
7,382
|
|
Total
|
18,665
|
|
|
17,945
|
|
|
2007 Equity
|
|
2013 Lumara
|
|
Inducement
|
|
|
||||
|
Plan
|
|
Equity Plan
|
|
Grants
|
|
Total
|
||||
Outstanding at December 31, 2017
|
2,590,373
|
|
|
125,536
|
|
|
815,450
|
|
|
3,531,359
|
|
Granted
|
451,411
|
|
|
—
|
|
|
—
|
|
|
451,411
|
|
Exercised
|
(7,782
|
)
|
|
—
|
|
|
—
|
|
|
(7,782
|
)
|
Expired or terminated
|
(160,797
|
)
|
|
(15,436
|
)
|
|
(27,875
|
)
|
|
(204,108
|
)
|
Outstanding at March 31, 2018
|
2,873,205
|
|
|
110,100
|
|
|
787,575
|
|
|
3,770,880
|
|
|
2007 Equity
|
|
2013 Lumara
|
|
Inducement
|
|
|
||||
|
Plan
|
|
Equity Plan
|
|
Grants
|
|
Total
|
||||
Outstanding at December 31, 2017
|
966,623
|
|
|
11,611
|
|
|
91,541
|
|
|
1,069,775
|
|
Granted
|
712,781
|
|
|
—
|
|
|
—
|
|
|
712,781
|
|
Vested
|
(317,638
|
)
|
|
(10,150
|
)
|
|
(15,666
|
)
|
|
(343,454
|
)
|
Expired or terminated
|
(38,078
|
)
|
|
(460
|
)
|
|
—
|
|
|
(38,538
|
)
|
Outstanding at March 31, 2018
|
1,323,688
|
|
|
1,001
|
|
|
75,875
|
|
|
1,400,564
|
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Cost of product sales and services
|
$
|
347
|
|
|
$
|
129
|
|
Research and development
|
720
|
|
|
756
|
|
||
Selling, general and administrative
|
4,466
|
|
|
4,893
|
|
||
Total equity-based compensation expense
|
5,533
|
|
|
5,778
|
|
||
Income tax effect
|
(942
|
)
|
|
(1,605
|
)
|
||
After-tax effect of equity-based compensation expense
|
$
|
4,591
|
|
|
$
|
4,173
|
|
•
|
$54.2 million
due to the net loss for the
three
months ended
March 31, 2018
;
|
•
|
$5.5 million
increase related to equity-based compensation expense;
|
•
|
$1.1 million
increase related to the cumulative effect adjustment to our accumulated deficit from the adoption of ASC 606, net of tax; and
|
•
|
$2.3 million
decrease due to the payment of employee tax withholdings related to equity-based compensation.
|
|
March 31, 2018
|
|
December 31, 2017
|
||||
2023 Senior Notes
|
$
|
466,595
|
|
|
$
|
466,291
|
|
2022 Convertible Notes
|
251,508
|
|
|
248,194
|
|
||
2019 Convertible Notes
|
20,460
|
|
|
20,198
|
|
||
Total long-term debt
|
738,563
|
|
|
734,683
|
|
||
Less: current maturities
|
20,460
|
|
|
—
|
|
||
Long-term debt, net of current maturities
|
$
|
718,103
|
|
|
$
|
734,683
|
|
|
2022 Convertible Notes
|
|
2019 Convertible Notes
|
|
Total
|
||||||
Liability component:
|
|
|
|
|
|
|
|
||||
Principal
|
$
|
320,000
|
|
|
$
|
21,417
|
|
|
$
|
341,417
|
|
Less: debt discount and issuance costs, net
|
68,492
|
|
|
957
|
|
|
69,449
|
|
|||
Net carrying amount
|
$
|
251,508
|
|
|
$
|
20,460
|
|
|
$
|
271,968
|
|
Equity Component
|
$
|
72,576
|
|
|
$
|
9,905
|
|
|
$
|
82,481
|
|
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.
|
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 measurement period in which the trading price per
$1,000
principal amount of the 2019 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.
|
|
Three Months Ended March 31,
|
||||||
|
2018
|
|
2017
|
||||
Contractual interest expense
|
$
|
2,734
|
|
|
$
|
1,250
|
|
Amortization of debt issuance costs
|
339
|
|
|
274
|
|
||
Amortization of debt discount
|
3,237
|
|
|
1,929
|
|
||
Total interest expense
|
$
|
6,310
|
|
|
$
|
3,453
|
|
Period
|
Future Annual Principal Payments
|
||
Remainder of Year Ending December 31, 2018
|
$
|
—
|
|
Year Ending December 31, 2019
|
21,417
|
|
|
Year Ending December 31, 2020
|
—
|
|
|
Year Ending December 31, 2021
|
—
|
|
|
Year Ending December 31, 2022
|
320,000
|
|
|
Thereafter
|
475,000
|
|
|
Total
|
$
|
816,417
|
|
|
Three Months Ended March 31,
|
|
2018 to 2017
|
|||||||||||
|
2018
|
|
2017
|
|
$ Change
|
|
% Change
|
|||||||
Product sales, net
|
|
|
|
|
|
|
|
|
|
|
||||
Makena
|
$
|
89,983
|
|
|
$
|
86,455
|
|
|
$
|
3,528
|
|
|
4
|
%
|
Feraheme
|
25,135
|
|
|
25,922
|
|
|
(787
|
)
|
|
(3
|
)%
|
|||
Intrarosa
|
2,165
|
|
|
—
|
|
|
2,165
|
|
|
N/A
|
|
|||
MuGard
|
65
|
|
|
140
|
|
|
(75
|
)
|
|
(54
|
)%
|
|||
Total
|
117,348
|
|
|
112,517
|
|
|
4,831
|
|
|
4
|
%
|
|||
Service revenues, net
|
28,969
|
|
|
26,931
|
|
|
2,038
|
|
|
8
|
%
|
|||
Other revenues
|
39
|
|
|
24
|
|
|
15
|
|
|
63
|
%
|
|||
Total revenues
|
$
|
146,356
|
|
|
$
|
139,472
|
|
|
$
|
6,884
|
|
|
5
|
%
|
|
Three Months Ended March 31,
|
|
2018 to 2017
|
|||||||||||||||||
|
2018
|
|
Percent of
gross product sales |
|
2017
|
|
Percent of
gross
product sales
|
|
$ Change
|
|
% Change
|
|||||||||
Gross product sales
|
$
|
239,870
|
|
|
|
|
$
|
206,724
|
|
|
|
|
$
|
33,146
|
|
|
16
|
%
|
||
Provision for product sales allowances and accruals:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
Contractual adjustments
|
86,144
|
|
|
36
|
%
|
|
69,829
|
|
|
34
|
%
|
|
16,315
|
|
|
23
|
%
|
|||
Governmental rebates
|
36,378
|
|
|
15
|
%
|
|
24,378
|
|
|
12
|
%
|
|
12,000
|
|
|
49
|
%
|
|||
Total
|
122,522
|
|
|
51
|
%
|
|
94,207
|
|
|
46
|
%
|
|
28,315
|
|
|
30
|
%
|
|||
Product sales, net
|
$
|
117,348
|
|
|
|
|
$
|
112,517
|
|
|
|
|
$
|
4,831
|
|
|
4
|
%
|
|
Three Months Ended March 31,
|
|
2018 to 2017
|
||||||||||
|
2018
|
|
2017
|
|
$ Change
|
|
% Change
|
||||||
Cost of product sales
|
$
|
63,912
|
|
|
$
|
27,573
|
|
|
$
|
36,339
|
|
|
>100 %
|
Percentage of net product sales
|
54
|
%
|
|
25
|
%
|
|
|
|
|
|
Three Months Ended March 31,
|
|
2018 to 2017
|
|||||||||||
|
2018
|
|
2017
|
|
$ Change
|
|
% Change
|
|||||||
Cost of services
|
$
|
5,473
|
|
|
$
|
5,010
|
|
|
$
|
463
|
|
|
9
|
%
|
Percentage of service revenues
|
19
|
%
|
|
19
|
%
|
|
|
|
|
|
Three Months Ended March 31,
|
|
2018 to 2017
|
|||||||||||
|
2018
|
|
2017
|
|
$ Change
|
|
% Change
|
|||||||
External research and development expenses
|
|
|
|
|
|
|
|
|||||||
Feraheme-related costs
|
$
|
592
|
|
|
$
|
2,492
|
|
|
$
|
(1,900
|
)
|
|
(76
|
)%
|
Makena-related costs
|
2,071
|
|
|
4,365
|
|
|
(2,294
|
)
|
|
(53
|
)%
|
|||
Bremelanotide-related costs
|
2,522
|
|
|
4,369
|
|
|
(1,847
|
)
|
|
(42
|
)%
|
|||
Intrarosa-related costs
|
1,458
|
|
|
—
|
|
|
1,458
|
|
|
N/A
|
|
|||
Other external costs
|
111
|
|
|
972
|
|
|
(861
|
)
|
|
(89
|
)%
|
|||
Total
|
6,754
|
|
|
12,198
|
|
|
(5,444
|
)
|
|
(45
|
)%
|
|||
Internal research and development expenses
|
4,055
|
|
|
4,291
|
|
|
(236
|
)
|
|
(5
|
)%
|
|||
Total research and development expenses
|
$
|
10,809
|
|
|
$
|
16,489
|
|
|
$
|
(5,680
|
)
|
|
(34
|
)%
|
|
Three Months Ended March 31,
|
|
2018 to 2017
|
|||||||||||
|
2018
|
|
2017
|
|
$ Change
|
|
% Change
|
|||||||
Compensation, payroll taxes and benefits
|
$
|
35,201
|
|
|
$
|
21,694
|
|
|
$
|
13,507
|
|
|
62
|
%
|
Professional, consulting and other outside services
|
46,857
|
|
|
38,864
|
|
|
7,993
|
|
|
21
|
%
|
|||
Fair value of contingent consideration liability
|
626
|
|
|
1,043
|
|
|
(417
|
)
|
|
(40
|
)%
|
|||
Amortization expense related to customer relationship intangible
|
3,900
|
|
|
3,930
|
|
|
(30
|
)
|
|
(1
|
)%
|
|||
Equity-based compensation expense
|
4,466
|
|
|
4,893
|
|
|
(427
|
)
|
|
(9
|
)%
|
|||
Total selling, general and administrative expenses
|
$
|
91,050
|
|
|
$
|
70,424
|
|
|
$
|
20,626
|
|
|
29
|
%
|
•
|
$13.5 million
increase in compensation, payroll taxes and benefits primarily due to increased costs in the first quarter of 2018 associated with the expansion of our women’s health sales force in the second half of 2017 and related organizational growth; and
|
•
|
$8.0 million
increase in external spending related to the launches of the expanded Feraheme label, the Makena auto-injector and Intrarosa.
|
|
March 31, 2018
|
|
December 31, 2017
|
|
$ Change
|
|
% Change
|
|||||||
Cash and cash equivalents
|
$
|
231,737
|
|
|
$
|
192,114
|
|
|
$
|
39,623
|
|
|
21
|
%
|
Marketable securities
|
138,820
|
|
|
136,593
|
|
|
2,227
|
|
|
2
|
%
|
|||
Total
|
$
|
370,557
|
|
|
$
|
328,707
|
|
|
$
|
41,850
|
|
|
13
|
%
|
|
|
|
|
|
|
|
|
|||||||
Outstanding principal on 2023 Senior Notes
|
$
|
475,000
|
|
|
$
|
475,000
|
|
|
$
|
—
|
|
|
—
|
%
|
Outstanding principal on 2022 Convertible Notes
|
320,000
|
|
|
320,000
|
|
|
—
|
|
|
—
|
%
|
|||
Outstanding principal on 2019 Convertible Notes
|
21,417
|
|
|
21,417
|
|
|
—
|
|
|
—
|
%
|
|||
Total
|
$
|
816,417
|
|
|
$
|
816,417
|
|
|
$
|
—
|
|
|
—
|
%
|
|
|
March 31, 2018
|
|
March 31, 2017
|
|
$ Change
|
||||||
Net cash provided by (used in) operating activities
|
|
$
|
45,692
|
|
|
$
|
(14,536
|
)
|
|
$
|
60,228
|
|
Net cash used in investing activities
|
|
(3,800
|
)
|
|
(1,387
|
)
|
|
(2,413
|
)
|
|||
Net cash used in financing activities
|
|
(2,269
|
)
|
|
(5,628
|
)
|
|
3,359
|
|
|||
Net increase (decrease) in cash, cash equivalents, and restricted cash
|
|
$
|
39,623
|
|
|
$
|
(21,551
|
)
|
|
$
|
61,174
|
|
•
|
Non-cash operating items, such as depreciation and amortization, impairment charges, IPR&D and equity-based compensation;
|
•
|
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;
|
•
|
Changes in deferred incomes taxes; and
|
•
|
Changes associated with the fair value of contingent payments associated with our acquisitions of businesses.
|
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) |
|||||
January 1, 2018 through January 31, 2018
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
1,429,021
|
|
February 1, 2018 through February 28, 2018
|
3,922
|
|
|
18.84
|
|
|
—
|
|
|
974,178
|
|
|
March 1, 2018 through March 31, 2018
|
108,233
|
|
|
20.99
|
|
|
—
|
|
|
1,017,690
|
|
|
Total
|
112,155
|
|
|
$
|
20.91
|
|
|
—
|
|
|
|
(1)
|
Represents 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 any of our common stock during the
first
quarter of
2018
. We have repurchased and retired
$39.5 million
of our common stock under our share repurchase program through
March 31, 2018
. These shares were purchased pursuant to a repurchase program authorized by our Board that was announced in January 2016 to repurchase up to $60.0 million of our common stock, of which
$20.5 million
remains authorized for repurchase as of
March 31, 2018
. The repurchase program does not have an expiration date and may be suspended for periods or discontinued at any time.
|
Exhibit
Number
|
|
Description
|
10.1+
|
|
|
10.2+
|
|
|
10.3+
|
|
|
31.1+
|
|
|
31.2+
|
|
|
32.1++
|
|
|
32.2++
|
|
|
101.INS+
|
|
XBRL Instance Document
|
101.SCH+
|
|
XBRL Taxonomy Extension Schema Document
|
101.CAL+
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.DEF+
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
101.LAB+
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
101.PRE+
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
+
|
Exhibits marked with a plus sign (“+”) are filed herewith.
|
++
|
Exhibits marked with a double plus sign (“++”) are furnished herewith.
|
|
|
|
|
|
AMAG PHARMACEUTICALS, INC.
|
||
|
|
|
|
|
By:
|
/s/ William K. Heiden
|
|
|
|
William K. Heiden
|
|
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
|
|
|
|
|
|
Date:
|
May 4, 2018
|
|
|
|
|
|
|
AMAG PHARMACEUTICALS, INC.
|
||
|
|
|
|
|
By:
|
/s/ Edward Myles
|
|
|
|
Edward Myles
|
|
|
|
Executive Vice President of Finance, Chief Financial Officer and Treasurer (Principal Financial and Accounting Officer)
|
|
|
|
|
|
|
Date:
|
May 4, 2018
|
“Base Operating Expenses:
|
With respect to the Third Additional Premises only, Landlord’s Operating Expenses (as hereinafter defined in Section 2.6) for calendar year 2018, being the period from January 1, 2018 through December 31, 2018.”
|
“Base Taxes:
|
With respect to the Third Additional Premises only, Landlord’s Tax Expenses (as hereinafter defined in Section 2.7) for fiscal year 2019, being the period from July 1, 2018 through June 30, 2019.”
|
“Number of Parking Privileges:
|
One hundred and ninety-eight (198) (being three (3) spaces per 1,000 square feet of Rentable Floor Area of the Premises).”
|
|
|
LANDLORD:
|
|
|
|
WITNESS:
/s/ Patrick Kimble
|
|
BP BAY COLONY LLC, a Delaware limited liability company
BY: BP BAY COLONY HOLDINGS LLC, a Delaware limited liability company, its sole member
BY: BOSTON PROPERTIES LIMITED PARTNERSHIP, a Delaware limited partnership, its member
BY: BOSTON PROPERTIES, INC., a Delaware corporation, its general partner
|
|
By:
|
/s/ Bryan J. Koop
|
|
Name:
|
Bryan J. Koop
|
|
Title:
|
Executive Vice President
|
|
|
TENANT:
|
WITNESS:
|
|
|
/s/ Chantal Sarmanoukian
|
|
AMAG PHARMACEUTICALS, INC., a Delaware corporation
|
|
By:
|
/s/ Edward Myles
|
|
Name:
|
Edward Myles
|
|
Title:
|
EVP & CFO
|
1.
|
Floor plan indicating location of partitions and doors (details required of partition and door types).
|
2.
|
Location of standard electrical convenience outlets and telephone outlets.
|
3.
|
Location and details of special electrical outlets; (e.g. Xerox), including voltage, amperage, phase and NEMA configuration of outlets.
|
4.
|
Reflected ceiling plan showing layout of standard ceiling and lighting fixtures. Partitions to be shown lightly with switches located indicating fixtures to be controlled.
|
5.
|
Locations and details of special ceiling conditions, lighting fixtures, speakers, etc.
|
6.
|
Location and heat load in BTU/Hr. of all special air conditioning and ventilating requirements and all necessary HVAC mechanical drawings.
|
7.
|
Location and details of special structural requirements, e.g., slab penetrations and areas with floor loadings exceeding a live load of 70 lbs./s.f.
|
8.
|
Locations and details of all plumbing fixtures; sinks, drinking fountains, etc.
|
9.
|
Location and specifications of floor coverings, e.g., vinyl tile, carpet, ceramic tile, etc.
|
10.
|
Finish schedule plan indicating wall covering, paint or paneling with paint colors referenced to standard color system.
|
11.
|
Details and specifications of special millwork, glass partitions, rolling doors and grilles, blackboards, shelves, etc.
|
12.
|
Hardware schedule indicating door number keyed to plan, size, hardware required including butts, latchsets or locksets, closures, stops, and any special items such as thresholds, soundproofing, etc. Keying schedule is required.
|
13.
|
Verified dimensions of all built-in equipment (file cabinets, lockers, plan files, etc.).
|
14.
|
Location of any special soundproofing requirements.
|
15.
|
All drawings to be uniform size (30” X 42”) and shall incorporate the standard project electrical and plumbing symbols and be at a scale of 1/8” = 1’ or larger.
|
16.
|
Drawing submittal shall include the appropriate quantity required for Landlord to file for permit along with four half size sets and one full size set for Landlord’s review and use.
|
17.
|
Provide all other information necessary to obtain all permits and approvals for Tenant’s Third Additional Premises Work.
|
18.
|
Upon completion of the Tenant’s Third Additional Premises Work, Tenant shall provide Landlord with two hard copies and one CAD file of all updated architectural and mechanical drawings to reflect all project sketches and changes.
|
If to AMAG, addressed to:
|
|
AMAG Pharmaceuticals, Inc.
|
|
[***]
|
|
1100 Winter Street
|
|
|
|
Waltham, MA 02451
[***]
|
|
With a copy to:
[***]
|
|
AMAG Pharmaceuticals, Inc.
1100 Winter Street
Waltham, MA 02451
[***]
|
|
|
|
||
If to Antares, addressed to:
|
|
Antares Pharma, Inc.
|
|
[***]
|
|
100 Princeton South, Suite 300
|
|
|
|
Ewing, NJ 08628
|
|
|
|
[***]
|
|
with a copy to:
|
|
Antares Pharma, Inc.
|
|
General Counsel
|
|
100 Princeton South, Suite 300
|
|
|
|
Ewing, NJ 08628
|
|
|
|
[***]
|
|
d.
|
Section 20.13 of the Agreement is hereby deleted in its entirety and replaced as follows:
|
3.
|
Effect of Amendment
. Except as amended hereby, all provisions of the Agreement, together with all Statements of Work governed by the Agreement, are hereby ratified and confirmed and shall continue in full force and effect and are incorporated herein by reference. This Amendment shall be governed by and construed consistently with the terms of the Agreement.
|
4.
|
Definitions
. All capitalized terms used but not otherwise defined in this Amendment shall have the meanings given to them in the Agreement.
|
5.
|
Governing Law
. This Amendment shall be governed by and interpreted in accordance with the substantive laws of the State of New York, without regard to its choice of law rules.
|
6.
|
Miscellaneous
. This Amendment may be executed in counterparts, each of which shall be deemed to be an original, but all of which together shall constitute one agreement. An executed copy of this Amendment may be delivered by electronic transmission, and electronic copies of executed signature pages shall be binding as originals. The headings of the various sections of this Amendment have been inserted for reference only and shall not be deemed to be a part of this Amendment.
|
AMAG PHARMACEUTICALS, INC.
|
|
ANTARES PHARMA, INC.
|
|
|
|
By:
/s/ William K. Heiden
|
|
By
:_/s/ Robert Apple
|
Name: William K. Heiden
|
|
Name: Robert Apple
|
Title: President and Chief Executive Officer
|
|
Title: President and Chief Executive Officer
|
|
|
|
AMAG PHARMA USA, INC.
|
|
|
|
|
|
By:
/s/ William K. Heiden
|
|
|
Name: William K. Heiden
|
|
|
Title: President and Chief Executive Officer
|
|
|
1.1
|
Definitions. Capitalized terms used in this Agreement and not otherwise defined in this Section 1.1 shall have the meanings set out in the Development and License Agreement. The following terms shall, unless the context otherwise requires, have the respective meanings set out below and grammatical variations of such terms shall have corresponding meanings:
|
(a)
|
specifications for Devices, Prefilled Syringes and Components;
|
(b)
|
the Product Specifications; and
|
(c)
|
storage, packaging, prescribing information and label specifications and requirements; and
|
1.2
|
Currency
. Unless otherwise indicated, all monetary amounts are expressed in this Agreement in the lawful currency of the United States of America.
|
1.3
|
Sections and Headings
. The division of this Agreement into Articles, Sections, subsections and Exhibits and the insertion of headings are for convenience of reference only and shall not affect the interpretation of this Agreement. Unless otherwise indicated, any reference in this Agreement to an Article, Section or Exhibit refers to the specified Article, Section or Exhibit to this Agreement. In this Agreement, the terms “this Agreement”, “hereof”, “herein”, “hereunder” and similar expressions refer to this Agreement and not to any particular part, Section, Exhibit or the provision hereof.
|
1.4
|
Singular Terms
. Except as otherwise expressly provided herein or unless the context otherwise requires, all references to the singular shall include the plural and vice versa.
|
1.5
|
Exhibits
. The following Exhibits are attached to, incorporated in and form part of this Agreement:
|
2.1
|
Manufacturing Services
.
|
(a)
|
Starting on the Effective Date, Antares or its Subcontractor shall provide the Manufacturing Services in order to manufacture Devices, Products, sample Products and Trainers exclusively for AMAG for the Territory, all in accordance with the Specifications, Applicable Laws, Quality Agreement and this Agreement. For the avoidance of doubt, subject to, and without limiting or amending the exclusivity restrictions and confidentiality obligations set forth in Section 6.1 and ARTICLE 17 of the Development and License Agreement, respectively, Antares or its Subcontractor may manufacture the VIBEX® QS device or other devices (other than the Device) for itself or other Persons. Antares or its Subcontractor shall conduct all Manufacturing Services at the Manufacturing Site and may change the Manufacturing Site for the Products, sample Products and Trainers only with the prior written consent of AMAG, such consent not to be unreasonably withheld, conditioned or delayed (provided that, Antares or its Subcontractor shall provide a minimum of [***] prior written notice of such change of Manufacturing Site).
|
(b)
|
[***].
|
(c)
|
Antares shall have the right to specify the final assembly packaging and labeling process (subject to AMAG’s provision of label content) for Products, sample Products and Trainers, including the combination of the components thereof, in accordance with the Specifications and the Quality Agreement.
|
2.2
|
Prefilled Syringes
.
|
(a)
|
AMAG or its designee(s) will be responsible for manufacture, formulation and testing of any Drug and the Prefilled Syringe for assembly with the Device into the Product
|
(b)
|
The Parties acknowledge and agree that title to and risk of loss of all Prefilled Syringes shall at all times belong to and remain in AMAG; provided that, subject to the limitations on liability set forth in this Section 2.2(b), in the event of loss or damage of any Prefilled Syringes while they are at the Manufacturing Site, Antares shall be only responsible for the replacement costs (as evidenced by AMAG invoices) of such Prefilled Syringes if the damage, loss, theft or destruction was caused by the negligent act or omission or the willful misconduct of Antares or its Subcontractor. For the avoidance of doubt, Antares shall not be responsible for any damage, loss or destruction to the Prefilled Syringes resulting from damage, loss or destruction caused by the reasonable amount of Prefilled Syringes damaged, lost or destroyed in the manufacturing process (i.e. consistent with the Yield) or obsolescence due to changes in the manufacturing process. Not later than [***] following the end of each Calendar Year, AMAG shall provide Antares with an invoice and accounting of the Prefilled Syringes that were damaged or destroyed during the prior year (following notification from Antares of such damage or destruction). Payment of undisputed portions of such invoice shall be due [***] from Antares’ receipt of such invoice. [***]. All Prefilled Syringes in Antares’ possession shall be subject to disposition by AMAG upon expiration or termination of this Agreement, and in either such event, Antares or its Subcontractor shall deliver the Prefilled Syringes to AMAG or its designee, at AMAG’s
|
(c)
|
All shipments of Prefilled Syringes made by AMAG or its designee to Antares or its Subcontractor hereunder will be delivered [***] Antares’ or its Subcontractor’s Manufacturing Site unless otherwise mutually agreed. [***].
|
2.3
|
Devices
. Antares or its Subcontractor shall manufacture and test all Devices as specified by the Product Specifications prior to using such Devices to manufacture Products and sample Products. Antares or its Subcontractor shall properly store the Devices at Antares’ or its Subcontractor’s storage facility at the Manufacturing Site pursuant to cGMP and Applicable Law.
|
2.4
|
Components
. Antares or its Subcontractor shall purchase and inspect all Components as specified by the Specifications prior to using such Components to manufacture Products, sample Products and Trainers. Antares or its Subcontractor shall properly store the Components at Antares’ or its Subcontractor’s storage facility at the Manufacturing Site pursuant to cGMP and Applicable Law.
|
2.5
|
Assembly of Devices, Prefilled Syringes and Components
. Antares or its Subcontractor shall assemble Devices, Prefilled Syringes and Components into Products, sample Products and Trainers (as applicable) in accordance with the terms of this Agreement.
|
2.6
|
Quality Control and Quality Assurance
.
|
(a)
|
On or about the date hereof, the Parties shall amend and restate the Quality Agreement entered into on May 16, 2016 between the Parties covering the Product, sample Products, Trainers, the Device and the Prefilled Syringes, as set forth in the form of Amended and Restated Quality Agreement attached hereto as
Exhibit E
(as amended and restated, the “
Quality Agreement
”). The Parties shall review the Quality Agreement and shall modify the same from time to time as detailed in the Quality Agreement as necessary through a written amendment to the Quality Agreement signed by an authorized representative on behalf of each of the Parties. The Parties shall perform the quality control and quality assurance testing specified in Section 2.6(b) and the Quality Agreement. The Parties shall perform Product, sample Product and Trainer review and final release of the Product, sample Product and Trainers for sale in accordance with Section 2.6(b) and the Quality Agreement, the Specifications and Applicable Laws.
|
(b)
|
Subject to, and as more fully set forth in, the Quality Agreement, the Parties agree as follows:
|
2.7
|
Labelling and Packaging
. Antares or its Subcontractor shall label and package the Products, sample Products and Trainers as set out in the Specifications. AMAG shall be responsible for the cost of artwork development for the Products, sample Products and Trainers. In addition, Antares or its Subcontractor shall arrange for and implement (a) the imprinting of batch numbers and expiration dates for each batch of Products and sample Products shipped, and (b) the imprinting of batch numbers for each batch of Trainers shipped. Such batch numbers and expiration dates shall be affixed on the Products, sample Products and Trainers and, on the shipping carton of each Product, sample Product and Trainer as outlined in the Specifications and, as required by cGMPs and Applicable Laws. The system used by Antares or its Subcontractor for batch numbering and expiration dates is detailed in
Exhibit F
hereto. AMAG shall be solely responsible for the content of the labelling and the provision of such content. Notwithstanding anything to the contrary in this Agreement, Antares’ obligation to perform the Manufacturing Services is subject to AMAG’s reasonably timely approval and provision of all labelling content. AMAG may, in its sole discretion, make changes to labels, product inserts and other packaging for the Products, sample Products and Trainers, which changes shall be submitted by AMAG to all applicable Regulatory Authorities from which approval of such changes is required. AMAG shall be responsible for the cost of labeling obsolescence due to changes to such labeling made by AMAG, including the reasonable cost of disposal and replacement of packaging materials. Antares’ name shall appear on the label or anywhere else on the Products, sample Products and Trainers as reasonably agreed upon by the Parties, unless: (i) prohibited by Applicable Laws; or (ii) the Parties otherwise agree in writing.
|
2.8
|
Validation Activities
. Antares or its Subcontractor will be responsible for the development and approval of the validation protocols for analytical methods and manufacturing processes (including packaging processes) for the Products, sample Products and Trainers as described in the Specifications in accordance with the Quality Agreement and shall be approved by AMAG prior to execution thereof. [***].
|
2.9
|
Retained Samples
. Antares or its Subcontractor shall retain sufficient quantities of shipped Products, sample Products, Devices and Components as retained repository samples as required under the Quality Agreement and Applicable Laws at AMAG’s sole cost and expense and as set forth in
Exhibit G
. Such retained samples shall minimally represent [***] the number of samples necessary to re-execute chemical release testing and will
be maintained in a suitable storage facility at Antares’ or its Subcontractors’ Manufacturing Site until [***] or such longer period as may be required by Applicable Laws. All such samples shall be available for inspection by AMAG at reasonable intervals upon reasonable
|
2.10
|
Yield
. [***].
|
3.1
|
Supply of Product
.
|
(a)
|
Commencing on the Effective Date and continuing during the Term, Antares shall manufacture and supply, or have manufactured and supplied by its Subcontractor, all quantities of the Products, sample Products and Trainers ordered by AMAG in the Territory pursuant to this Agreement. Commencing on the Effective Date and during the Term, AMAG shall commit to purchase its entire requirements of Product(s), sample Products and Trainers for sale in the Territory from Antares.
|
(b)
|
The Parties agree that in the event that AMAG seeks Regulatory Approval for the Product, sample Product or Trainers for a country outside of the United States, the Parties will enter into an amendment to this Agreement setting forth the terms and conditions of supply of Products, sample Products or Trainers for that country.
|
3.2
|
Orders and Forecasts
.
|
(a)
|
Rolling Forecasts
. On or before the [***] after the Effective Date, AMAG shall provide Antares with an updated written [***] rolling forecast of the volume of Product, sample Product and Trainers that AMAG then anticipates will be required to be produced and delivered to AMAG during [***] (the “
Forecast
”). The initial Forecast is attached hereto as
Exhibit H
. [***] of each Forecast shall constitute a firm order and be a binding commitment on AMAG to purchase the volume of Product, sample Product and Trainers set forth therein (the “
Binding Forecast
”). [***] of each Forecast shall be non-binding (the “
Non-binding Forecast
”). The Non-binding Forecast shall be prepared in good faith by AMAG and represent AMAG’s reasonable expectation of its requirements of Product, sample Product and Trainers for [***] of such Forecast. Each Forecast shall include an estimated delivery date of the Prefilled Syringes to Antares or its Subcontractor (such estimate to be provided by AMAG in good faith).
|
(b)
|
Purchase Orders
.
|
(i)
|
To order Products, sample Products and Trainers for supply by Antares or its Subcontractor under this Agreement, AMAG shall submit to Antares a Purchase Order (which is deemed binding on AMAG) complying with the other applicable terms of this Agreement [***]. Not later than [***] after receipt of a Purchase
|
(ii)
|
AMAG and Antares acknowledge and agree that any minor difference between the quantity of ordered and delivered quantity of Product, sample Product or Trainers (as the case may be) that falls within applicable industry standards shall be accepted by AMAG as delivery in full of the ordered quantities set forth on any Firm Order and shall not be deemed a shortage as set forth in Section 5.1(c), but in no event shall the quantity delivered deviate from the quantity ordered by more than: [***].
|
(iii)
|
Notwithstanding anything in this Agreement to the contrary, AMAG acknowledges and agrees that Antares shall only be responsible for producing and delivering to AMAG that portion (up to the entire quantity) of Products and sample Products requested pursuant to a Purchase Order for which Antares or its Subcontractor (as the case may be) possesses, at least [***] prior to the Delivery Date, a sufficient stock of inventory of Prefilled Syringes necessary to
|
(iv)
|
Notwithstanding anything in this Agreement to the contrary, AMAG acknowledges and agrees that Antares shall not be responsible for delay in the delivery of quantity of Products, sample Products or Trainers (as the case may be) set forth in any Firm Order to the extent such delay is caused primarily due to AMAG’s failure to fulfill the AMAG Quality Tasks to enable Antares and/or its Subcontractor to timely perform the Manufacturing Services.
|
(c)
|
Prior Orders
. [***].
|
3.3
|
Minimum Orders
. The quantity of Products, sample Products or Trainers (as the case may be) ordered by AMAG from Antares in each shipment (as set forth in a Purchase Order) must be equal to or greater than [***] units for each type of Product, sample Product and Trainers ordered. Such minimum order quantity may be updated from time to time by a mutual written agreement of the Parties. For avoidance of doubt, except for any Purchase Orders placed by AMAG and/or quantities set forth in the Binding Forecast, nothing in this Agreement requires AMAG to purchase any particular quantity of Products from Antares.
|
3.4
|
Shipments
.
|
(a)
|
Shipments of Products, sample Product and Trainers shall be made EXW (as such term is defined in INCOTERMS 2010) Antares’ or its Subcontractor’s (as the case may be) designated shipping location unless otherwise mutually agreed. The Parties acknowledge and agree that delivery of Products, samples Products and/or Trainers under this Agreement shall be deemed to be made once the Products, samples Products and/or Trainers (as the case may be) are made available at Antares’ or its Subcontractor’s (as the case may be) designated shipping location. [***]. AMAG shall pay for shipping. AMAG shall arrange for insurance and shall select the freight
|
(b)
|
Prior to release for distribution, sale or use by AMAG pursuant to Section 2.6(b)(v)(D), AMAG, its agent or its permitted subcontractor shall test each batch of Products, sample Products and Trainers manufactured under this Agreement in accordance with Section 2.6(b)(v)(D). AMAG, its agent or its permitted subcontractor shall conduct all such testing in accordance with the procedures and using the analytical testing methodologies set forth in the Specifications, the Quality Agreement and Applicable Laws. All Products, sample Products and Trainers shipped by Antares or its Subcontractor to AMAG or AMAG’s designee, including its packaging, shall meet all applicable export and customs laws, regulations and like requirements for the United States.
|
3.5
|
Supply Failure
.
|
3.6
|
Safety Stock
.
|
(a)
|
At AMAG’s sole cost and expense, Antares or its Subcontractor will maintain and make available to AMAG a safety inventory of the Major Device Components necessary to assemble the Devices in the quantities set forth in this Section 3.6(a)
at Antares or its Subcontractor’s Manufacturing Site in accordance with this Section 3.6 (“
Safety Stock
”).
|
(i)
|
[***].
|
(ii)
|
[***].
|
(b)
|
With respect to the initial Safety Stock (as set forth in Section 3.6(a)(i)) or any increase in Safety Stock pursuant to Section 3.6(a)(ii), upon the completion of the manufacture of such Safety Stock and delivery to AMAG of the Certificate of Analysis (Device) and the Certificate of Conformance (Device) applicable to such Safety Stock, Antares shall invoice AMAG for its [***] pursuant to invoicing and payment terms set forth in Section 4.2.
|
(c)
|
With respect to any reduction in the Safety Stock pursuant to Sections 3.6(a)(ii) or 3.6(d), to the extent such reduced quantities of Safety Stock are used in the manufacture of fully finished Products and/or sample Products, then Antares shall credit any amount previously paid by AMAG with respect to such reduced quantity in Safety Stock in the Invoice issued to AMAG pursuant to Section 4.2 for such fully finished Product and/or sample Product.
|
(d)
|
Antares or its Subcontractor shall manage the Safety Stock as part of its overall inventory and use the Safety Stock to fulfill its obligations pursuant to a Firm Orders on a first in/first out basis. As such inventory of Safety Stock is used as part of the Manufacturing Services of Product and/or sample Product, Antares shall use Commercially Reasonable Efforts to replenish the Safety Stock to the level set forth in Section 3.6(a)(i) (as adjusted pursuant to Section 3.6(a)(ii)) within [***] of receipt of such Firm Order.
|
(e)
|
Title and risk of loss of the Safety Stock shall transfer to AMAG upon the delivery to AMAG of the Certificate of Conformance (Device) and Certificate of Analyses (Device) for the applicable shipment of such Safety Stock from Antares’ Subcontractor that manufactured such Safety Stock. Antares shall not be responsible for any insurance with respect to the risk of loss of such Safety Stock.
|
(f)
|
In the event any Safety Stock expires, Antares or its Subcontractor shall dispose of or destroy such Safety Stock in accordance with the Quality Agreement. AMAG shall reimburse Antares for any costs or expenses incurred (without markup) in connection with such disposal or destruction.
|
(g)
|
Notwithstanding the quantities set forth in Section 3.6(a), Antares or its Subcontractor shall maintain and store the Safety Stock during the Term of this Agreement, provided that during the last [***] before expiration or termination of this Agreement, Antares or its Subcontractor is only required to maintain that amount of Safety Stock as is required to deliver amounts set forth in the then-current Forecast(s) until such expiration or termination date. AMAG shall reimburse Antares for any reasonable costs or expenses incurred (without markup) in connection with maintaining or storing the Safety Stock.
|
3.7
|
Manufacture at Risk
.
|
(a)
|
In the event AMAG desires for Antares and/or its Subcontractor to initiate Manufacturing Services with respect to any Product or sample Product prior to the receipt of the Certificate of Analysis (PFS Manufacture) and the Certificate of Analysis (PFS ID Testing) (“
Manufacture(d) at Risk
”), AMAG shall deliver written notice of such to Antares. Notwithstanding anything in this Agreement to the contrary, Antares shall not be required to perform any Manufacturing Services with respect to the Product or sample Product until Antares receives (i) such written notice of AMAG’s intention to Manufacture at Risk as set forth in the first sentence of this Section 3.7(a), or (ii) the Certificate of Analysis (PFS Manufacture) and the Certificate of Analysis (PFS ID Testing).
|
(b)
|
[***].
|
3.8
|
Redundancy Plan
.
Antares shall, at the Party’s respective costs set forth on
Exhibit I
, develop, implement and maintain an the redundancy plan for molds, tooling and assemblies for the manufacturing of the Devices set forth on
Exhibit I
.
|
3.9
|
Qualification of Second Source Supplier(s)
.
Antares shall, upon AMAG’s written request provided to Antares and at AMAG’s cost (as set forth in this Section 3.9), identify and reasonably verify the suitability of one or more Third Persons as a “backup” supplier of Devices (each, a “
Second Source Supplier
”) in addition to Antares’ then-current supplier of Devices (whether Antares or its then-current Subcontractor). Within [***] following the receipt of such written request, the Parties will negotiate in good faith a budget for the costs and expenses associated with the Second Source Supplier, including all costs and expenses for the establishment and qualification thereof. Within [***] following the agreement by both Parties of such budget, Antares will use Commercially Reasonable Efforts to establish and qualify such Second Source Supplier; provided, however, that the Joint Project Team under the Development and License Agreement may agree to extend such time periods. AMAG shall have the right to propose a Second Source Supplier and Antares shall have the right to consent to such Second Source Supplier, which consent shall not be unreasonably withheld or delayed. Within [***] of a receipt of an invoice thereof, AMAG shall reimburse Antares for all documented costs and expenses (without markup) associated with the Second Source Supplier, including all documented costs and expense for the establishment and qualification thereof; provide that such costs and expenses, in the aggregate, shall not exceed [***] of the agreed-upon budget (as set forth above).
|
3.10
|
Right to Purchase Directly from Subcontractors or Second Source Suppliers
.
|
(a)
|
If (i) a Force Majeure Event affecting solely Antares (specifically excluding its Subcontractors or Second Source Suppliers) lasts for [***] which prevents Antares from fulfilling its financial obligations to a Subcontractor or a Second Source Supplier, or (ii) Antares is otherwise in material breach of its financial obligations to a Subcontractor or a Second Source Supplier for a period of at least [***] then Antares shall promptly deliver to AMAG a written notice of such event or breach. Following the receipt of such notice, or following Antares’ material breach of its obligation to deliver such notice under this Section 3.10(a), AMAG may deliver written notice to Antares of its intention to exercise its rights under this Section 3.10.
|
(b)
|
For the period commencing on Antares’ receipt of such notice from AMAG as set forth in Section 3.10(a) and ending [***] thereafter, Antares and AMAG shall negotiate in good faith a commercially reasonable agreement with respect to the Force Majeure Event or material breach describe in Section 3.10(a)(i) or 3.10(a)(ii), respectively, which may include, AMAG advancing payment for Manufacturing Services on terms to be negotiated among the Parties (an “Alternate Arrangement”). If, following the expiration of such [***] period, the Parties cannot mutually agree on a commercially
|
(c)
|
Provided that (i) AMAG and Antares have agreed to the terms of an Alternate Arrangement, or (ii) AMAG commences purchasing Devices, Components, Products, sample Products and/or Trainers directly from Antares’ Subcontractors or Second Source Supplier(s) pursuant to the terms of Section 3.10(b), AMAG’s election of its right to purchase Devices, Components, Products, sample Products and/or Trainers directly from Antares’ Subcontractor(s) or Second Source Supplier(s) under this Section 3.10 shall be AMAG’s sole and exclusive remedy, and Antares’ sole liability, with respect to Antares’ failure to supply such Devices, Components, Products, sample Products and/or Trainers for the reasons specified in Section 3.10(a); provided, that, if AMAG does not elect such right, AMAG shall not be prohibited from exercising all other rights available to AMAG under this Agreement and at law.
|
4.1
|
Prices
.
|
(a)
|
During the Term, Antares or its Subcontractor shall deliver Products, sample Products and Trainers ordered by AMAG in accordance with this Agreement at the Transfer Prices set forth on
Exhibit D
.
|
(b)
|
[***].
|
4.2
|
Invoices and Payment
.
|
4.3
|
Records; Financial Audit Request
. With respect to audits of Antares’ records relating to the establishment of the Transfer Price, [***] or any other amounts payable by AMAG hereunder, including, without limitation, pursuant to Section 4.6, Article 11 of the Development and License Agreement is hereby incorporated by reference herein and made a part of this Agreement.
|
4.4
|
Taxes
.
|
(a)
|
The Transfer Price includes all taxes except (i) such sales and use taxes which Antares is required by law to collect from AMAG and (ii) to the extent imposed on the date of this Agreement or as a result of a change in law, VAT. Such VAT and taxes, if any, will be payable in addition to the Transfer Price. Where Antares is required by law to collect and/or account for such VAT and taxes from AMAG, such VAT and taxes will be separately stated in Antares’s Invoice and will be paid by AMAG to Antares unless AMAG provides an exemption to Antares and, in the case of VAT, subject to Antares providing a valid VAT invoice to AMAG in the form and manner required by law to allow AMAG to recover such VAT (to the extent AMAG is allowed to do so by law). For avoidance of doubt, any increase in VAT imposed as a result of any action taken by Antares, and not consented to by AMAG, after the date of this Agreement shall not be paid by AMAG or otherwise included in the Transfer Price.
|
(b)
|
Except where AMAG is required by Applicable Law to account for any VAT to the applicable Governmental Authority, Antares shall be solely responsible for the timely payment of all such VAT and taxes to the applicable Governmental Authority
|
(c)
|
Notwithstanding the foregoing in this Section 4.4, AMAG shall be responsible for the payment of all duties, tariffs, VAT, taxes and similar charges payable on the exportation or importation of the Products, sample Products or Trainers. Without limiting any of Antares’s obligations hereunder, Antares shall cooperate with and assist AMAG in all aspects of the shipment, exportation, importation and delivery process in order to ensure the expeditious delivery of the Product to the designated delivery point, including assisting in obtaining any documents that may be required.
|
4.5
|
[***].
|
4.6
|
[***].
|
5.1
|
Product Claims
.
|
(a)
|
Product Claims
. [***].
|
(b)
|
Determination of Deficiency
. [***].
|
(c)
|
Shortages
. [***].
|
5.2
|
Product Recalls and Returns
.
|
(a)
|
Records and Notice
. In addition to the requirements of Section 6.2, Antares and AMAG shall each maintain such records in compliance with Applicable Laws as is reasonably necessary to permit a Recall of any Products, sample Products and Trainers delivered to AMAG, AMAG’s designee or customers of AMAG. Each Party shall promptly (but no later than [***] of receipt of such information) notify the other by telephone (to be confirmed in writing) of any information which might affect the marketability, safety, or effectiveness of the Products, sample Products or Trainers and/or which might result in the Recall or seizure of the Products, sample Products, or Trainers. Upon receiving any such notice or upon any such discovery, each Party shall cease and desist from further shipments of such Products, sample Products or Trainers in its possession or control until a decision by AMAG has been made whether a Recall or some other corrective action is necessary.
|
(b)
|
Recalls
. The decision to initiate a Recall or to take some other corrective action, if any, shall be made and implemented by AMAG in its sole discretion after consultation with Antares. AMAG shall be responsible for managing all Recalls and Antares shall cooperate with AMAG as AMAG may reasonably request. Subject to Antares’ obligation to cover the costs set forth in Section 5.3(b), AMAG shall be responsible for all costs incurred due to the Recall of a Product, sample Product or Trainer.
|
(c)
|
Product Returns
. AMAG shall have the responsibility for handling customer returns of the Products, sample Products and Trainers.
|
5.3
|
Antares’ Responsibility for Defective and Recalled Products
.
|
(a)
|
Defective Product.
[***].
|
(b)
|
Recalled Product
. [***].
|
5.4
|
Disposition of Defective or Recalled Products
. AMAG shall not dispose of any damaged, defective, returned or Recalled Products, sample Products or Trainers in relation to which it intends to assert a claim against Antares without Antares’ prior written authorization to do so, unless otherwise required by Applicable Laws. Alternatively, Antares may instruct AMAG to return such Products, sample Products and Trainers to Antares at Antares’ expense. Antares shall bear the cost of disposition with respect to any damaged, defective, returned or Recalled Products, sample Products or Trainers in relation to which it bears responsibility under Sections 5.1, 5.2 or 5.3 hereof. In all other circumstances, AMAG shall bear the cost of disposition with respect to any damaged, defective, returned or Recalled Products, sample Products and Trainers.
|
5.5
|
Customer Questions or Complaints
. AMAG shall have the sole right and responsibility for responding to questions and complaints from AMAG’s customers. Antares shall refer any questions and complaints (including safety and efficacy inquiries, quality complaints
|
6.1
|
Governmental Agencies
. Subject to the Regulatory Authority inspection obligations set forth in Section 6.3, Antares and/or its Subcontractor(s) may communicate with any Regulatory Authority regarding the Products, sample Products and Trainers only if, in the reasonable opinion of Antares’ and/or its Subcontractor’s counsel, such communication is necessary to comply with the terms of this Agreement or Applicable Laws; provided, however, that unless, in the reasonable opinion of Antares’ and/or its Subcontractor’s counsel, there is a legal prohibition against doing so, Antares shall notify AMAG reasonably in advance of any such communication and permit AMAG to accompany Antares and/or its Subcontractor and take part in any communications with such Regulatory Authority, and provide AMAG with copies of all such communications from such Regulatory Authority.
|
6.2
|
Records and Accounting by Antares
. Antares shall keep records of the manufacture, testing and shipping of the Products, sample Products and Trainers and retain samples of such Products, sample Products and Trainers as are necessary to comply with cGMPs, Applicable Laws, the Quality Agreement, and manufacturing regulatory requirements applicable to Antares, as well as to assist with resolving Product, sample Product and Trainer complaints and other similar investigations. Copies of such records and samples shall be retained for the respective periods set forth in the Quality Agreement.
|
6.3
|
Regulatory Inspections
. Antares shall permit the FDA and other Regulatory Authorities to conduct inspections of each Manufacturing Site as they may request, including pre-approval inspections, and shall cooperate with such Regulatory Authorities with respect to the inspections and any related matters, in each case which is related to the Device, Product or sample Product. Antares shall give AMAG notice within [***] of becoming aware of any such inspections, and keep AMAG reasonably informed about the results and conclusions of each regulatory inspection, including actions taken by Antares or its Subcontractor to
|
6.4
|
Quality Audit
. The Parties rights and obligations with respect to quality assurance audits are set forth in the Quality Agreement.
|
6.5
|
Reports
. Antares will promptly supply on an annual basis and when reasonably requested by AMAG from time to time, at no additional charge, all available information and data in its control that AMAG reasonably requires in order to complete any filing for, or apply for, obtain or maintain, regulatory approvals under any applicable regulatory regime (including any Annual Report that AMAG is required to file with the FDA), including without limitation information relating to the Manufacturing Site, Development Report (as described in ICH guidelines), Manufacturing Services, Device, Product, sample Product, Trainers or the process, methodology, raw materials and intermediates used in the manufacture, processing, or packaging of the Device, Product, sample Product or Trainers, release test results, complaint test results, all investigations (in manufacturing, testing and storage), and all information required to be submitted in the CMC (chemistry, manufacturing and controls) section of an IND or a NDA or other regulatory filings, or required or requested to be provided to any Regulatory Authority. At AMAG’s reasonable written request, Antares shall be responsible for supporting AMAG’s Annual Product Review Report, consistent with cGMPs, Applicable Laws, and customary FDA or other Regulatory Authority requirements. Any additional report requested by AMAG beyond the scope of what is required or recommended under cGMPs, Applicable Laws and customary FDA or other Regulatory Authority requirements shall be subject to an additional fee to be agreed upon between Antares and AMAG. In addition, Antares shall cooperate with AMAG with respect to all reporting obligations relevant to the Product, sample Product and Trainers under Applicable Laws.
|
6.6
|
Regulatory Filings
. Responsibility for regulatory filings shall be as set forth in Section 4.1 of the Development and License Agreement.
|
7.1
|
Term
. Subject to early termination of this Agreement pursuant to Sections 7.2, 7.3 or 7.4, this Agreement shall become effective as of the Effective Date and shall continue until the expiration or earlier termination of the Development and License Agreement (the “
Term
”).
|
7.2
|
Termination By AMAG
. This Agreement may be terminated in its entirety by AMAG, upon AMAG’s prior written notice to Antares:
|
(a)
|
Subject to Sections 11.1 and 12.4, if Antares commits a material breach of this Agreement and such material breach remains uncured for [***] following written notice of breach by Antares. Notwithstanding the foregoing, AMAG’s termination rights with respect to an Antares’ failure to supply Products, sample Products or Trainers, including a Supply Failure, are not subject this Section 7.2(a) and are set forth in Section 7.2(b);
|
(b)
|
Subject to Section 12.4, if a Supply Failure remains uncured for [***] following written notice of such failure to Antares; provided, however, that AMAG may not terminate this Agreement if Antares’ failure to supply Products, sample Products or Trainers is a result of Force Majeure Event under Section 12.4 or AMAG’s breach of this Agreement including, but not limited to, failure to provide adequate quantities of Prefilled Syringe;
|
(c)
|
If Antares is subject to a petition for relief under any bankruptcy legislation, or makes an assignment for the benefit of creditors, or is subject to the appointment of a receiver for all or a substantial part of Antares’ assets, and such petition, assignment or appointment prevents Antares (as a legal or as a practical matter) from performing its obligations under this Agreement, or such petition, assignment or appointment is not otherwise dismissed or vacated within [***]; or
|
(d)
|
Upon [***] written notice to Antares in the event that AMAG permanently ceases commercializing the Product for efficacy or safety reasons, as evidenced by the placement of the Product on the Discontinued Drug Product List of the FDA Orange Book publication (“
Approved Drug Products with Therapeutic Equivalence Evaluations
”).
|
7.3
|
Termination by Antares
. This Agreement may be terminated in its entirety by Antares upon Antares’ prior written notice to AMAG:
|
(a)
|
Subject to Sections 11.1 and 12.4, if AMAG commits a material breach of this Agreement and such material breach remains uncured for [***] following written notice of breach by Antares;
|
(b)
|
If AMAG is subject to a petition for relief under any bankruptcy legislation, or makes an assignment for the benefit of creditors, or is subject to the appointment of a receiver for all or a substantial part of AMAG’s assets, and such petition, assignment or appointment prevents AMAG (as a legal or as a practical matter) from performing its obligations under this Agreement, or such petition, assignment or appointment is not otherwise dismissed or vacated within [***]; or
|
(c)
|
Upon [***] written notice to AMAG in the event that AMAG permanently ceases commercializing the Product for efficacy or safety reasons, as evidenced by the placement of the Product on the Discontinued Drug Product List of the FDA Orange Book publication (“
Approved Drug Products with Therapeutic Equivalence Evaluations
”).
|
7.4
|
Co-Termination
. Without further action by either Party, this Agreement shall automatically terminate effective immediately upon the termination of the Development and License Agreement in its entirety, subject to the provisions that expressly survive the termination thereof.
|
7.5
|
Remedies for Material Breach
.
|
(a)
|
Remedies for AMAG
. Subject to Sections 11.1 and 12.4, in the event of an uncured material breach by Antares that would entitle AMAG to terminate this Agreement under Section 7.2(a) and Section 7.2(b), in addition to and independent of AMAG’s right to terminate this Agreement, AMAG may seek monetary damages (whether or not this Agreement is terminated) for such material breach and/or equitable relief to prevent such material breach from continuing or occurring again in the future.
|
(b)
|
Remedies for Antares
. Subject to Sections 11.1 and 12.4, in the event of a uncured material breach by AMAG that would entitle Antares to terminate this Agreement under Section 7.3(a), in addition to and independent of Antares’ right to terminate this Agreement, Antares may seek monetary damages (whether or not this Agreement is terminated) for such material breach and/or equitable relief to prevent such material breach from continuing or occurring again in the future.
|
7.6
|
Effects of Expiration or Termination of this Agreement
.
|
(a)
|
If this Agreement expires or is terminated for any reason, then (in addition to any other remedies either Party may have in the event of material breach by the other Party):
|
(b)
|
[***].
|
(c)
|
[***].
|
(d)
|
[***].
|
(e)
|
Except with respect to AMAG’s right to sell off existing inventory as set forth in Section 7.6(d), the Parties acknowledge and agree that following any expiration or termination of this Agreement, all rights and licenses granted to AMAG under this Agreement or the Development and License Agreement shall terminate and AMAG shall cease using and selling any Products, sample Products or Trainers.
|
(f)
|
Any termination or expiration of this Agreement shall not affect any outstanding obligations or payments due hereunder prior to such termination or expiration, nor shall it prejudice any other remedies that the Parties may have under this Agreement or Applicable Laws (except as otherwise provided in this Agreement). For greater certainty, termination of this Agreement for any reason shall not affect the obligations and responsibilities of the Parties pursuant to ARTICLE 1 (Interpretation), ARTICLE 9 (Remedies and Indemnities) (provided that, the obligation to maintain the insurance coverages set forth in Section 9.3 shall only survive for the time period set forth therein), ARTICLE 10 (Confidentiality), ARTICLE 11 (Dispute Resolution), and Sections 2.9 (Retained Samples) (for the period set forth therein), 4.4 (Taxes), 5.2 (Product Recalls and Returns); 5.5 (Customer Questions or Complaints) (for a period of [***] from the date of termination or expiration); 6.2 (Regulatory and Accounting by Antares) (for the period set forth therein), 7.6 (Effects of Expiration or Termination of this Agreement), 12.1 (Agency), 12.2 (Assignment) 12.5 (Notices), 12.6 (Amendment), 12.7 (Waiver) and 12.10 (Governing Law), all of which survive any termination or expiration.
|
(g)
|
Termination, relinquishment or expiration of the Agreement for any reason shall be without prejudice to any rights which shall have accrued to the benefit of either Party prior to (or as a result of, including, without limitation, rights available under law and equity) such termination, relinquishment or expiration. Such termination, relinquishment or expiration shall not relieve either Party from obligations that are expressly indicated to survive termination or expiration of the Agreement.
|
8.1
|
Authority. Each Party hereby represents, warrants and covenants to the other Party that: (i) it has the full right and authority to enter into this Agreement and to grant to the other Party the rights granted to such other Party under this Agreement, (ii) it has obtained all necessary corporate approvals to enter and execute this Agreement, and (iii) that it is not aware of any impediment that would inhibit its ability to perform its obligations hereunder.
|
8.2
|
AMAG Warranties. AMAG hereby represents, warrants and covenants to Antares as follows:
|
(a)
|
AMAG, or a Third Person manufacturing Drug and Pre-Filled Syringes on behalf of AMAG, shall manufacture the Drug and Pre-Filled Syringe in accordance with the Specifications, cGLP, cGCP, cGMP and cQSRs, this Agreement, the Quality Agreement and Applicable Laws including, without limitation, federal, state, or local laws, regulations, or guidelines governing manufacturing at the site where such manufacturing is being conducted;
|
(b)
|
AMAG, or a Third Person manufacturing Drug and Pre-Filled Syringes on behalf of AMAG, shall obtain and maintain all necessary licenses, permits and approvals required by Applicable Laws in connection with the manufacture the Drug and Pre-Filled Syringe, and supply of Drug and Prefilled Syringes to Antares or its Subcontractor;
|
(c)
|
That all Drug or Prefilled Syringes manufactured by AMAG, or a Third Person on behalf of AMAG, when delivered to Antares or its Subcontractor (i) will comply with applicable Product Specifications and Certificate of Analysis (PFS Manufacture); (ii) will not be adulterated or misbranded within the meaning of any Applicable Laws effective at the time of delivery and will not be an article which may not be introduced into interstate commerce under any Applicable Laws; (iii) will be delivered to Antares or its Subcontractor (as the case may be) free and clear of all liens and encumbrances, and (iv) will be in compliance with cGMPs and all Applicable Laws;
|
(d)
|
That all Products and sample Products, when released by AMAG for distribution, sale or use pursuant to Section 2.6(b)(v)(D): (i) will comply with applicable Product Specifications, Batch Record, Certificate of Analysis Certificate of Analysis (PFS Manufacture), the Certificate of Analysis (PFS ID Testing), Certificate of Analysis (Product) and the Certificate of Conformance (Product); (ii) will not be adulterated or misbranded within the meaning of any Applicable Laws effective at the time of delivery and will not be an article which may not be introduced into interstate commerce under any Applicable Laws; and (iii) will be in compliance with cGMPs and all Applicable Laws;
|
(e)
|
Prior to the first commercial sale by AMAG or a Third Person on behalf of AMAG of Products, sample Product and Trainers in a given market, the Products, sample Product and Trainers, if labelled and manufactured in accordance with the Specifications and in compliance with applicable cGMPs and Applicable Laws, have received the necessary marketing approvals from applicable Regulatory Authorities for sale, distribution and use in such market;
|
(f)
|
AMAG has the requisite legal title and ownership under its intellectual property necessary for it to fulfill its obligations under this Agreement, and that there is no pending or threatened litigation, arbitration, government proceeding, or government investigation (and AMAG has not received any communication relating thereto) which alleges that AMAG’s past activities relating to the Drug or activities proposed under this Agreement infringe or misappropriate any of the intellectual property rights of any Third Person, and to AMAG’s actual knowledge, there is no intellectual property of any Third Person that would be infringed or misappropriated by Antares or its Subcontractor carrying out the Manufacturing Services in accordance with this Agreement; and
|
(g)
|
AMAG agrees that federal securities law may prohibit it, its Affiliates and its representatives from purchasing or selling any securities of Antares while it is in possession of material, non-public information of Antares, and that it will not disclose any material, non-public information, directly or indirectly, to any party for the purpose of encouraging such party to trade in Antares’s securities and that it will comply at all times with the applicable securities laws and regulations.
|
8.3
|
Antares Warranties
. Antares hereby represents, warrants and covenants to AMAG as follows:
|
(a)
|
Antares or its Subcontractor shall perform the Manufacturing Services in accordance with the Specifications, cGLP, cGCP, cGMPs and cQSRs, this Agreement, the Quality Agreement and Applicable Laws including, without limitation, federal, state, or local laws, regulations, or guidelines governing manufacturing at the Manufacturing Sites;
|
(b)
|
Antares or its Subcontractor shall obtain and maintain all necessary licenses, permits and approvals required by Applicable Laws in connection with the Manufacturing Services, manufacture of Devices and supply of Products, sample Products or Trainers to AMAG;
|
(c)
|
As of the Effective Date, Antares has disclosed to AMAG any and all FDA Form 483’s, warning letters or similar notices relating to the Manufacturing Site and import alerts for any other products manufactured in the Manufacturing Site issued during the last [***];
|
(d)
|
[***];
|
(e)
|
Antares has the requisite legal title and ownership of intellectual property necessary for it to fulfill its obligations under this Agreement, and that there is no pending or threatened litigation, arbitration, government proceeding, or government investigation (and Antares has not received any communication relating thereto) which alleges that Antares’ past activities relating to [***] devices or activities proposed under this
|
(f)
|
Antares agrees that federal securities law may prohibit it, its affiliates and its representatives from purchasing or selling any securities of AMAG while it is in possession of material, non-public information of AMAG, and that it will not disclose any material, non-public information, directly or indirectly, to any party for the purpose of encouraging such party to trade in AMAG’s securities and that it will comply at all times with the applicable Federal Securities Laws and regulations.
|
(g)
|
[***].
|
8.4
|
Debarred Persons
. Each of the Parties covenants, represents and warrants that: (i) neither it nor any of its employees or, subcontractors performing Manufacturing Services have been “debarred” by the FDA, or subject to a similar sanction from another Regulatory Authority; nor have debarment proceedings against said Party or any of its employees or subcontractors performing Manufacturing Services been commenced; and (ii) it will not in the performance of its obligations under this Agreement use the services of any person debarred or suspended by the FDA as described in 21 U.S.C. §335(a) or (b). Said Party will promptly notify the other Party in writing if any such debarment proceedings have commenced or if said Party or any of its employees or subcontractors performing Manufacturing Services are debarred by the FDA or other Regulatory Authorities. Each of the Parties further covenants, represents and warrants that it does not currently have, and will not hire, as an officer or an employee any person who has been convicted of a felony under the laws of the United States for conduct relating to the regulation of any drug product under the Federal Food, Drug, and Cosmetic Act
.
|
8.5
|
Permits
. As between the Parties, AMAG shall be solely responsible for obtaining or maintaining, on a timely basis, any permits or other Regulatory Approvals in respect of the Products, sample Products, Trainers, Specifications, including, without limitation, all marketing and post-marketing approvals.
|
8.6
|
No Warranty
. NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW, OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS AGREEMENT, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR WARRANTY OF MERCHANTABILITY OR WARRANTY OF NON-INFRINGEMENT OF THIRD PERSON RIGHTS.
|
9.1
|
Antares’ Right to Indemnification
. AMAG shall indemnify each of Antares, its Affiliates, its Subcontractors and their respective successors and assigns, and the directors, officers, employees, and agents thereof (the “
Antares Indemnitees
”), defend and hold each Antares Indemnitee harmless from and against any and all liabilities, damages, losses, settlements, claims, actions, suits, penalties, fines, costs or expenses (including, without limitation reasonable attorneys’ fees) (any of the foregoing, “
Damages
”) incurred by or asserted against any Antares Indemnitee of whatever kind or nature, including, without limitation, any claim or liability based upon negligence, warranty, strict liability, violation of government regulation or infringement of patent or other proprietary rights, but only to the extent arising from or occurring as a result of a claim or demand made by a Third Person (a “
Third Person Claim
”) against any Antares Indemnitee because of (a) breach of any warranty made by AMAG pursuant to Section 8.2 hereof; (b) the Product, sample Product or Trainer (including the content of any labelling and the decision to release the Product, sample Product or Trainer) unless attributable to an item identified in Section 9.2 below which is under the responsibility of Antares or its Subcontractors; (c) the distribution or detailing of any Product, sample Product or Trainer by or on behalf of AMAG or its sublicensees, except to the extent such claim is attributable to an item identified in Section 9.2(f) below which is under the responsibility of Antares; (d) any allegation that the manufacture, use, sale, offer for sale or importation of a Product, sample Product or Trainer infringes any patent, other intellectual property rights or other proprietary rights of a Third Person, except to the extent such infringement relates to the manufacture, use, sale, offer for sale or importation of a Device (including a Device incorporated into a Product) or any delivery system including the Device; or (e) any breach of this Agreement by AMAG, except, in each such case, to the extent that such Damages are finally determined to have resulted from the negligence or misconduct of Antares. Antares shall promptly notify AMAG of any Third Person Claim upon becoming aware thereof, and shall permit AMAG, at AMAG’s cost, to defend against such Third Person Claim and to control the defense and disposition (including, without limitation, selection its counsel and all decisions to litigate, settle or appeal) of such claim, and shall cooperate in the defense thereof. Antares may, at its option and expense, have its own counsel participate in any proceeding that is under the direction of AMAG and shall cooperate with AMAG and its insurer in the disposition of any such matter.
|
9.2
|
AMAG’s Right to Indemnification
. Antares shall indemnify each of AMAG, its Affiliates, and their respective successors and assigns, and the directors, officers, employees, and agents thereof (the “
AMAG Indemnitees
”), defend and hold each AMAG Indemnitee harmless from and against any and all Damages incurred by or asserted against any AMAG Indemnitee of whatever kind or nature, including, without limitation, any claim or liability based upon negligence, warranty, strict liability, violation of government regulation or infringement of
|
9.3
|
Insurance
. Each Party shall obtain and maintain commercial general liability insurance, including product liability insurance covering the obligations of that Party under this Agreement through the Term and for a period of [***] thereafter, which insurance shall afford limits of not less than (i) $[***] for each occurrence; and (ii) $[***] in the aggregate per annum. Such insurance may be provided in more than one separate insurance policy and/or on claims made or claims made and reported forms as is common in the insurance marketplace for similar risks. If requested each Party will provide the other with a current and valid certificate of insurance evidencing the above and showing the name of the issuing company, the policy number, the effective date, the expiration date and the limits of liability. If a Party is unable to maintain the insurance policies required under this Agreement through no fault on the part of such Party, then such Party shall forthwith notify the other Party in writing and the Parties shall in good faith negotiate appropriate amendments to the insurance provision of this Agreement in order to provide adequate assurances.
|
9.4
|
Limitation of Liability
.
|
11.1
|
Commercial Disputes
. In the event of any dispute arising out of or in connection with this Agreement [***], the Parties shall first try to solve it amicably. In this regard, any Party may send a notice of dispute to the other, and each Party shall appoint, within [***] from receipt of such notice of dispute, a senior executive representative having full power and authority to solve the dispute. The representatives so designated shall meet as necessary in order to solve such dispute. If the dispute has not been resolved within [***] after the end of the [***] negotiation period referred to above (which period may be extended by mutual agreement), then such dispute shall be subject to any other remedy available under this Agreement or at law or equity.
|
11.2
|
[***].
|
12.1
|
Agency
. Neither Party is, nor shall be deemed to be, an employee, agent, co-venturer or legal representative of the other Party for any purpose. Neither Party shall be entitled to enter into any contracts in the name of, or on behalf of the other Party, nor shall either Party be entitled to pledge the credit of the other Party in any way or hold itself out as having the authority to do so.
|
12.2
|
Assignment
. Except as otherwise provided in this Section 12.2, neither this Agreement nor any interest hereunder shall be assignable by any Party without the prior written consent of the other (which consent shall not be unreasonably withheld, conditioned or delayed); provided, however, that either Party may assign this Agreement to any wholly-owned subsidiary or to any successor by merger or sale of substantially all of its business unit to which this Agreement relates. This Agreement shall be binding upon the successors and permitted assignees of the Parties. Any purported assignment in violation of this paragraph shall be void and ineffectual and shall not operate to transfer or assign any interest or title to the purported assignee.
|
12.3
|
Further Actions
. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
|
12.4
|
Force Majeure
. Neither Party shall be liable to the other for loss or damages or shall have any right to terminate this Agreement for any default or delay attributable to any force majeure event outside of the affected Party’s reasonable control, including, but not limited to, acts of God, acts of government, war, fire, flood, earthquake, terrorist acts, strike, labor dispute and the like (each, a “
Force Majeure Event
”), if the Party affected shall give prompt notice of any such cause to the other Party. The Party giving such notice shall thereupon be excused from such of its obligations hereunder as it is disabled by the Force Majeure Event from performing for so long as it is so disabled; provided, however, that such affected Party commences and continues to take reasonable and diligent actions to cure such cause throughout such disability.
|
12.5
|
Notices
. All notices and other communications hereunder shall be in writing and shall be deemed given if delivered personally or by electronic mail or facsimile transmission (receipt verified), telexed, mailed by registered or certified mail (return receipt requested), postage prepaid, or sent by express courier service, to the Parties at the following addresses (or at such other address for a Party as shall be specified by like notice; provided, that notices of a change of address shall be effective only upon receipt thereof):
|
If to AMAG, addressed to:
|
|
AMAG Pharmaceuticals, Inc.
|
[***]
|
|
1100 Winter Street
|
|
|
Waltham, MA 02451
[***]
|
With a copy to:
[***]
|
|
AMAG Pharmaceuticals, Inc.
100 Winter Street
Waltham, MA 02451
[***]
|
|
|
|
If to Antares, addressed to:
|
|
Antares Pharma, Inc.
|
[***]
|
|
100 Princeton South, Suite 300
|
|
|
Ewing, NJ 08628
[***]
|
|
|
|
with a copy to:
|
|
|
General Counsel
|
|
Antares Pharma, Inc.
|
|
|
100 Princeton South, Suite 300
|
|
|
Ewing, NJ 08628
|
|
|
[***]
|
12.1
|
Amendment
. No amendment, modification or supplement of any provision of the Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each Party.
|
12.2
|
Waiver
. No provision of the Agreement shall be waived by any act, omission or knowledge of a Party or its agents or employees except by an instrument in writing expressly waiving such provision and signed by a duly authorized officer of the waiving Party. No waiver of any term, provision or condition of this Agreement whether by conduct or otherwise in any one or more instances shall be deemed to be or construed as a further or continuing waiver of any such term, provision or condition or of any other term, provision or condition of this Agreement.
|
12.3
|
Counterparts; Electronic Copies
. The Agreement may be executed simultaneously in two or more counterparts, either one of which need not contain the signature of more than one Party but both such counterparts taken together shall constitute one and the same agreement. A facsimile transmission or portable document format (PDF) electronic transmission of this signed Agreement by a Party’s authorized representative shall be legal and binding upon such Party.
|
12.4
|
Descriptive Headings
. The descriptive headings of this Agreement are for convenience only, and shall be of no force or effect in construing or interpreting any of the provisions of this Agreement.
|
12.5
|
Governing Law; Choice of Forum
. This Agreement shall be governed by and interpreted in accordance with the substantive laws of the State of New York, without regard to its conflict of law provisions. The Parties agree that the United Nations Convention on Contracts for the International Sale of Goods does not apply to this Agreement. Except as otherwise provided in ARTICLE 11, all claims and proceedings under this Agreement shall be brought exclusively in the state or federal courts of competent subject matter jurisdiction in New York City, State of New York. The Parties hereby waive (i) any objection which it may have at any time to the venue of the proceeding in any such court, (ii) any claim that such proceedings have been brought in an inconvenient forum, and (iii) the right to object, with respect to such proceedings, that such court does not have any jurisdiction over such Party.
|
12.6
|
Severability
. Whenever possible, each provision of the Agreement will be interpreted in such manner as to be effective and valid under Applicable Law, but if any provision of the Agreement is held to be prohibited by or invalid under Applicable Law, such provision will be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of the Agreement. In the event of such invalidity, the Parties shall seek to agree on an alternative enforceable provision that preserves the original purpose of this Agreement.
|
12.7
|
Entire Agreement of the Parties
. This Agreement, including the Exhibits attached hereto, the Quality Agreement and the Development and License Agreement constitute and contain the complete, final and exclusive understanding and agreement of the Parties hereto, and cancels and supersedes any and all prior negotiations, correspondence, understandings and agreements, whether oral or written, between the Parties respecting the subject matter hereof. In the event there is a discrepancy between the Exhibits and the Agreement, the Agreement shall control, provided that to the extent there is a discrepancy between the Quality Agreement and the Agreement, the Quality Agreement shall control with respect to quality-related matters; and this Agreement shall control with respect to all other matters. Furthermore, to the extent that any provision of this Agreement is inconsistent with any provision of the Development and License Agreement, this Agreement shall control and then only to the extent of the inconsistency. For the avoidance of doubt, this Agreement supersedes and replaces Sections 10.2 and 10.3 of the Development and License Agreement.
|
12.8
|
Jointly Prepared
. This Agreement has been prepared jointly by both Parties and shall not be strictly construed against either Party.
|
Part Name
|
Material Specification
|
Lead-Time
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Part Number
|
Description
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Item
|
Financial Responsibility
|
Primary
|
Back-up On Hand
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Part Number
|
Description
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
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:
|
May 4, 2018
|
|
|
|
|
|
|
/s/ William K. Heiden
|
|
|
William K. Heiden
|
|
|
President and Chief Executive Officer
(Principal Executive Officer)
|
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;
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3.
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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;
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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:
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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;
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b.
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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
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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
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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
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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.
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Date:
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May 4, 2018
|
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/s/ Edward Myles
|
|
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Edward Myles
|
|
|
Executive Vice President of Finance, Chief Financial Officer and Treasurer
(Principal Financial Officer)
|
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.
|
|
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/s/ William K. Heiden
|
|
William K. Heiden
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
|
|
|
|
May 4, 2018
|
|
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/ Edward Myles
|
|
Edward Myles
|
|
Executive Vice President of Finance, Chief Financial Officer and Treasurer
|
|
(Principal Financial Officer)
|
|
|
|
|
May 4, 2018
|
|