R
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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o
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (No Fee Required)
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Delaware
(State or other jurisdiction of
incorporation or organization)
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04-3324394
(I.R.S. Employer
Identification No.)
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|
|
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8 Sylvan Way
Parsippany, New Jersey
(Address of principal executive offices)
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07054
(Zip Code)
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Large accelerated filer
o
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Accelerated filer
þ
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Non-accelerated filer
o
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Smaller reporting company
o
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|
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(Do not check if a smaller reporting company)
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Part I. Financial Information
|
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EX-10.1
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EX-10.2
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EX-10.3
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EX-10.4
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EX-10.5
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EX-10.6
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EX-31.1
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EX-31.2
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EX-32.1
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EX-32.2
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September 30,
2011 |
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December 31,
2010 |
||||
ASSETS
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(unaudited)
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
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$
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258,035
|
|
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$
|
126,364
|
|
Available for sale securities
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49,739
|
|
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120,280
|
|
||
Accrued interest receivable
|
443
|
|
|
1,279
|
|
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Accounts receivable, net of allowances of approximately $15.8 million and $15.5 million at September 30, 2011 and December 31, 2010, respectively
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72,725
|
|
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46,551
|
|
||
Inventory
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30,426
|
|
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25,343
|
|
||
Prepaid expenses and other current assets
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7,452
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|
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4,804
|
|
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Total current assets
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418,820
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|
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324,621
|
|
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Fixed assets, net
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18,528
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20,662
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|
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Intangible assets, net
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86,147
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82,925
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Goodwill
|
14,671
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|
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14,671
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Restricted cash
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4,626
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|
|
5,778
|
|
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Deferred tax assets, net
|
93,582
|
|
|
25,197
|
|
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Other assets
|
289
|
|
|
270
|
|
||
Total assets
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$
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636,663
|
|
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$
|
474,124
|
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LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
10,432
|
|
|
$
|
8,594
|
|
Accrued expenses
|
113,655
|
|
|
76,242
|
|
||
Deferred revenue
|
1,183
|
|
|
534
|
|
||
Total current liabilities
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125,270
|
|
|
85,370
|
|
||
Contingent purchase price
|
28,204
|
|
|
25,387
|
|
||
Other liabilities
|
5,896
|
|
|
5,769
|
|
||
Total liabilities
|
159,370
|
|
|
116,526
|
|
||
Stockholders' equity:
|
|
|
|
||||
Preferred stock, $1.00 par value per share, 5,000,000 shares authorized; no shares issued and outstanding
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—
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|
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—
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|
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Common stock, $0.001 par value per share, 125,000,000 shares authorized; 54,093,961 and 53,464,145 issued and outstanding at September 30, 2011 and December 31, 2010, respectively
|
54
|
|
|
53
|
|
||
Additional paid-in capital
|
609,013
|
|
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596,667
|
|
||
Accumulated deficit
|
(131,247
|
)
|
|
(239,542
|
)
|
||
Accumulated other comprehensive income
|
(527
|
)
|
|
420
|
|
||
Total stockholders' equity
|
477,293
|
|
|
357,598
|
|
||
Total liabilities and stockholders' equity
|
$
|
636,663
|
|
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$
|
474,124
|
|
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Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2011
|
|
2010
|
|
2011
|
|
2010
|
||||||||
Net revenue
|
$
|
120,773
|
|
|
$
|
105,743
|
|
|
$
|
352,501
|
|
|
$
|
317,966
|
|
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Cost of revenue
|
39,459
|
|
|
31,568
|
|
|
112,859
|
|
|
93,905
|
|
||||
Research and development
|
26,550
|
|
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16,676
|
|
|
76,878
|
|
|
54,128
|
|
||||
Selling, general and administrative
|
45,353
|
|
|
35,788
|
|
|
124,701
|
|
|
121,318
|
|
||||
Total operating expenses
|
111,362
|
|
|
84,032
|
|
|
314,438
|
|
|
269,351
|
|
||||
Income from operations
|
9,411
|
|
|
21,711
|
|
|
38,063
|
|
|
48,615
|
|
||||
Legal settlement
|
—
|
|
|
—
|
|
|
17,984
|
|
|
—
|
|
||||
Other income
|
578
|
|
|
483
|
|
|
1,450
|
|
|
55
|
|
||||
Income before income taxes
|
9,989
|
|
|
22,194
|
|
|
57,497
|
|
|
48,670
|
|
||||
Benefit (provision) for income taxes
|
62,625
|
|
|
(989
|
)
|
|
50,798
|
|
|
(2,607
|
)
|
||||
Net income
|
$
|
72,614
|
|
|
$
|
21,205
|
|
|
$
|
108,295
|
|
|
$
|
46,063
|
|
Basic earnings per common share
|
$
|
1.36
|
|
|
$
|
0.40
|
|
|
$
|
2.03
|
|
|
$
|
0.87
|
|
Diluted earnings per common share
|
$
|
1.34
|
|
|
$
|
0.40
|
|
|
$
|
2.00
|
|
|
$
|
0.87
|
|
Weighted average number of common shares outstanding:
|
|
|
|
|
|
|
|
||||||||
Basic
|
53,534
|
|
|
52,991
|
|
|
53,414
|
|
|
52,773
|
|
||||
Diluted
|
54,260
|
|
|
53,359
|
|
|
54,242
|
|
|
53,005
|
|
|
Nine Months Ended September 30,
|
||||||
|
2011
|
|
2010
|
||||
Cash flows from operating activities:
|
|
|
|
||||
Net income
|
$
|
108,295
|
|
|
$
|
46,063
|
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
||||
Depreciation and amortization
|
4,514
|
|
|
5,085
|
|
||
Amortization of net premiums and discounts on available for sale securities
|
2,021
|
|
|
2,432
|
|
||
Unrealized foreign currency transaction losses (gain), net
|
596
|
|
|
(596
|
)
|
||
Non-cash stock compensation expense
|
8,376
|
|
|
6,855
|
|
||
Loss on disposal of fixed assets
|
310
|
|
|
6
|
|
||
Deferred tax (benefit) provision
|
(68,385
|
)
|
|
710
|
|
||
Adjustment to contingent purchase price
|
2,817
|
|
|
2,265
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accrued interest receivable
|
836
|
|
|
—
|
|
||
Accounts receivable
|
(26,011
|
)
|
|
(4,214
|
)
|
||
Inventory
|
(4,973
|
)
|
|
(3,656
|
)
|
||
Prepaid expenses and other current assets
|
(2,602
|
)
|
|
2,450
|
|
||
Accounts payable
|
1,805
|
|
|
4,275
|
|
||
Accrued expenses
|
32,264
|
|
|
(12,481
|
)
|
||
Deferred revenue
|
618
|
|
|
(691
|
)
|
||
Other liabilities
|
128
|
|
|
122
|
|
||
Net cash provided by operating activities
|
60,609
|
|
|
48,625
|
|
||
Cash flows from investing activities:
|
|
|
|
||||
Purchases of available for sale securities
|
(33,835
|
)
|
|
(100,830
|
)
|
||
Proceeds from maturities and sales of available for sale securities
|
102,356
|
|
|
80,140
|
|
||
Purchases of fixed assets
|
(879
|
)
|
|
(151
|
)
|
||
|
|
|
|
||||
Adjustment to goodwill
|
—
|
|
|
263
|
|
||
Decrease in restricted cash
|
1,143
|
|
|
1,285
|
|
||
Net cash provided by (used in) investing activities
|
68,785
|
|
|
(19,293
|
)
|
||
Cash flows from financing activities:
|
|
|
|
||||
Proceeds from issuances of common stock, net
|
3,972
|
|
|
2,764
|
|
||
Net cash provided by financing activities
|
3,972
|
|
|
2,764
|
|
||
Effect of exchange rate changes on cash
|
(1,695
|
)
|
|
848
|
|
||
Increase in cash and cash equivalents
|
131,671
|
|
|
32,944
|
|
||
Cash and cash equivalents at beginning of period
|
126,364
|
|
|
72,225
|
|
||
Cash and cash equivalents at end of period
|
$
|
258,035
|
|
|
$
|
105,169
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
||||
Taxes paid
|
$
|
6,783
|
|
|
$
|
229
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2011
|
|
2010
|
|
2011
|
|
2010
|
||||||||
|
(in thousands, except per share amounts)
|
||||||||||||||
Basic and diluted
|
|
|
|
|
|
|
|
||||||||
Net income
|
$
|
72,614
|
|
|
$
|
21,205
|
|
|
$
|
108,295
|
|
|
$
|
46,063
|
|
|
|
|
|
|
|
|
|
||||||||
Weighted average common shares outstanding, basic
|
53,534
|
|
|
52,991
|
|
|
53,414
|
|
|
52,773
|
|
||||
Plus: net effect of dilutive stock options and restricted common shares
|
726
|
|
|
368
|
|
|
828
|
|
|
232
|
|
||||
Weighted average common shares outstanding, diluted
|
54,260
|
|
|
53,359
|
|
|
54,242
|
|
|
53,005
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Earnings per share, basic
|
$
|
1.36
|
|
|
$
|
0.40
|
|
|
$
|
2.03
|
|
|
$
|
0.87
|
|
Earnings per share, diluted
|
$
|
1.34
|
|
|
$
|
0.40
|
|
|
$
|
2.00
|
|
|
$
|
0.87
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2011
|
|
2010
|
|
2011
|
|
2010
|
||||||||
|
(in thousands)
|
||||||||||||||
Net income
|
$
|
72,614
|
|
|
$
|
21,205
|
|
|
$
|
108,295
|
|
|
$
|
46,063
|
|
Unrealized gain (loss) on available for sale securities
|
(20
|
)
|
|
80
|
|
|
—
|
|
|
61
|
|
||||
Foreign currency translation adjustment
|
(817
|
)
|
|
79
|
|
|
(947
|
)
|
|
126
|
|
||||
Comprehensive income
|
$
|
71,777
|
|
|
$
|
21,364
|
|
|
$
|
107,348
|
|
|
$
|
46,250
|
|
|
As of September 30, 2011
|
|
As of December 31, 2010
|
||||||||||||||||||||||||||||
|
Cost
|
|
Fair Value
|
|
Carrying
Value
|
|
Unrealized
Gain
|
|
Cost
|
|
Fair Value
|
|
Carrying
Value
|
|
Unrealized
Gain
|
||||||||||||||||
|
(in thousands)
|
||||||||||||||||||||||||||||||
U.S. government agency notes
|
$
|
14,917
|
|
|
$
|
14,919
|
|
|
$
|
14,919
|
|
|
$
|
2
|
|
|
$
|
55,222
|
|
|
$
|
55,222
|
|
|
$
|
55,222
|
|
|
$
|
—
|
|
U.S. treasury notes
|
3,054
|
|
|
3,056
|
|
|
3,056
|
|
|
2
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Corporate debt securities
|
31,765
|
|
|
31,764
|
|
|
31,764
|
|
|
(1
|
)
|
|
65,055
|
|
|
65,058
|
|
|
65,058
|
|
|
3
|
|
||||||||
Total
|
$
|
49,736
|
|
|
$
|
49,739
|
|
|
$
|
49,739
|
|
|
$
|
3
|
|
|
$
|
120,277
|
|
|
$
|
120,280
|
|
|
$
|
120,280
|
|
|
$
|
3
|
|
Level 1
|
Quoted prices in active markets for identical assets or liabilities. The Company's Level 1 assets and liabilities consist of money market investments and U.S. treasury notes.
|
Level 2
|
Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. The Company's Level 2 assets and liabilities consist of U.S. government agency notes and corporate debt securities.
|
Level 3
|
Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The Company's Level 3 assets and liabilities consist of the contingent purchase price associated with the Targanta acquisition. The fair value of the contingent purchase price was determined utilizing a probability weighted discounted financial model based on management's assessment of the likelihood of achievement of certain development and net sales milestones.
|
Assets and Liabilities
|
|
Quoted Prices In
Active Markets for Identical Assets
(Level 1)
|
|
Significant Other Observable Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
Balance at September 30, 2011
|
||||||||
|
|
(in thousands)
|
||||||||||||||
Assets:
|
|
|
|
|
|
|
|
|
||||||||
Money market
|
|
$
|
16,540
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
16,540
|
|
U.S. treasury notes
|
|
3,056
|
|
|
—
|
|
|
—
|
|
|
3,056
|
|
||||
U.S. government agency notes
|
|
—
|
|
|
14,919
|
|
|
—
|
|
|
14,919
|
|
||||
Corporate debt securities
|
|
—
|
|
|
31,764
|
|
|
—
|
|
|
31,764
|
|
||||
Total assets at fair value
|
|
$
|
19,596
|
|
|
$
|
46,683
|
|
|
$
|
—
|
|
|
$
|
66,279
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
||||||||
Contingent purchase price
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
28,204
|
|
|
$
|
28,204
|
|
Total liabilities at fair value
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
28,204
|
|
|
$
|
28,204
|
|
|
Level 3
|
||
|
(in thousands)
|
||
Balance at December 31, 2010
|
$
|
25,387
|
|
Fair value adjustment to contingent purchase price included in net income
|
2,817
|
|
|
Balance at September 30, 2011
|
$
|
28,204
|
|
Inventory
|
|
September 30,
2011 |
|
December 31,
2010 |
||||
|
|
(in thousands)
|
||||||
Raw materials
|
|
$
|
8,079
|
|
|
$
|
9,801
|
|
Work-in-progress
|
|
16,217
|
|
|
7,183
|
|
||
Finished goods
|
|
6,130
|
|
|
8,359
|
|
||
Total
|
|
$
|
30,426
|
|
|
$
|
25,343
|
|
|
|
|
As of September 30, 2011
|
|
As of December 31, 2010
|
||||||||||||||||||||
|
Weighted Average
Useful Life
|
|
Gross
Carrying
Amount
|
|
Accumulated
Amortization
|
|
Net
Carrying
Amount
|
|
Gross
Carrying
Amount
|
|
Accumulated
Amortization
|
|
Net
Carrying
Amount
|
||||||||||||
|
|
|
(in thousands)
|
||||||||||||||||||||||
Identifiable intangible assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Customer relationships
(1)
|
8 years
|
|
$
|
7,457
|
|
|
$
|
(2,576
|
)
|
|
$
|
4,881
|
|
|
$
|
7,457
|
|
|
$
|
(1,715
|
)
|
|
$
|
5,742
|
|
Distribution agreement
(1)
|
8 years
|
|
4,448
|
|
|
(1,536
|
)
|
|
2,912
|
|
|
4,448
|
|
|
(1,023
|
)
|
|
3,425
|
|
||||||
Trademarks
(1)
|
8 years
|
|
3,024
|
|
|
(1,045
|
)
|
|
1,979
|
|
|
3,024
|
|
|
(695
|
)
|
|
2,329
|
|
||||||
Product license
(2)
|
5 years
|
|
5,000
|
|
|
—
|
|
|
5,000
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Cleviprex milestones
(3)
|
13 years
|
|
2,000
|
|
|
(125
|
)
|
|
1,875
|
|
|
2,000
|
|
|
(71
|
)
|
|
1,929
|
|
||||||
Total
|
9 years
|
|
$
|
21,929
|
|
|
$
|
(5,282
|
)
|
|
$
|
16,647
|
|
|
$
|
16,929
|
|
|
$
|
(3,504
|
)
|
|
$
|
13,425
|
|
(1)
|
The Company amortizes intangible assets related to Angiox based on the ratio of annual forecasted revenue compared to total forecasted revenue from the sale of Angiox through the end of its patent life.
|
(2)
|
The Company amortizes intangible assets related to the product license over the life of the agreement.
|
(3)
|
The Company amortizes intangible assets related to the Cleviprex approval over the remaining life of the patent.
|
|
As of September 30, 2011
|
|
As of December 31, 2010
|
||||||||||||||||||
|
Gross
Carrying
Amount
|
|
Accumulated
Amortization
|
|
Net
Carrying
Amount
|
|
Gross
Carrying
Amount
|
|
Accumulated
Amortization
|
|
Net
Carrying
Amount
|
||||||||||
|
(in thousands)
|
||||||||||||||||||||
Intangible assets not subject to amortization:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
In-process research and development
|
$
|
69,500
|
|
|
—
|
|
|
$
|
69,500
|
|
|
$
|
69,500
|
|
|
—
|
|
|
$
|
69,500
|
|
Total
|
$
|
69,500
|
|
|
—
|
|
|
$
|
69,500
|
|
|
$
|
69,500
|
|
|
—
|
|
|
$
|
69,500
|
|
|
September 30,
2011 |
|
December 31,
2010 |
||||
|
(in thousands)
|
||||||
Balance at beginning of period
|
$
|
14,671
|
|
|
$
|
14,934
|
|
Adjustment to goodwill
|
—
|
|
|
(263
|
)
|
||
Balance at end of period
|
$
|
14,671
|
|
|
$
|
14,671
|
|
|
Balance as of January 1, 2011
|
|
Expenses (Income), Net
|
|
Cash
|
|
Noncash
|
|
Balance as of September 30, 2011
|
||||||||||
|
(in thousands)
|
||||||||||||||||||
Employee severance and other personnel benefits:
|
|
|
|
|
|
|
|
|
|
||||||||||
2011 Leipzig closure
|
$
|
—
|
|
|
$
|
849
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
849
|
|
|
2010 workforce reductions
|
134
|
|
|
(119
|
)
|
|
(15
|
)
|
|
—
|
|
|
—
|
|
|||||
Leases and equipment write-offs
|
10
|
|
|
304
|
|
|
(10
|
)
|
|
(304
|
)
|
|
—
|
|
|||||
Other associated costs
|
—
|
|
|
918
|
|
|
—
|
|
|
—
|
|
|
918
|
|
|||||
Total
|
$
|
144
|
|
|
$
|
1,952
|
|
|
$
|
(25
|
)
|
|
$
|
(304
|
)
|
|
$
|
1,767
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
||||||||||||||||||||
|
2011
|
|
|
|
2010
|
|
|
2011
|
|
|
|
2010
|
|
||||||||||||
|
(in thousands)
|
|
|
|
|
|
(in thousands)
|
|
|||||||||||||||||
Net revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
United States
|
$
|
111,561
|
|
|
92.4
|
%
|
|
$
|
100,234
|
|
94.8
|
%
|
|
$
|
328,849
|
|
|
93.3
|
%
|
|
$
|
301,065
|
|
94.7
|
%
|
Europe
|
6,060
|
|
|
5.0
|
%
|
|
4,018
|
|
3.8
|
%
|
|
18,429
|
|
|
5.2
|
%
|
|
13,613
|
|
4.3
|
%
|
||||
Rest of world
|
3,152
|
|
|
2.6
|
%
|
|
1,491
|
|
1.4
|
%
|
|
5,223
|
|
|
1.5
|
%
|
|
3,288
|
|
1.0
|
%
|
||||
Total net revenue
|
$
|
120,773
|
|
|
|
|
$
|
105,743
|
|
|
|
$
|
352,501
|
|
|
|
|
$
|
317,966
|
|
|
|
September 30,
2011 |
|
|
|
December 31,
2010 |
|
||||||
|
(in thousands)
|
|
||||||||||
Long-lived assets:
|
|
|
|
|
|
|
||||||
United States
|
$
|
118,451
|
|
|
99.0
|
%
|
|
$
|
117,095
|
|
98.8
|
%
|
Europe
|
1,121
|
|
|
0.9
|
%
|
|
1,213
|
|
1.0
|
%
|
||
Rest of world
|
63
|
|
|
0.1
|
%
|
|
220
|
|
0.2
|
%
|
||
Total long-lived assets
|
$
|
119,635
|
|
|
|
|
$
|
118,528
|
|
|
Product or Product
in Development
|
|
Development Stage
|
|
Mechanism/Target
|
|
Clinical Indication(s)
|
Angiomax
|
|
Marketed
|
|
Direct thrombin inhibitor
|
|
U.S. - for use as an anticoagulant in combination with aspirin in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty, or PTCA, and for use in patients undergoing percutaneous coronary intervention, or PCI, including patients with or at risk of heparin induced thrombocytopenia and thrombosis syndrome, or HIT/HITTS
|
|
|
|
|
|
|
Europe - for use as an anticoagulant in patients undergoing PCI, adult patients with acute coronary syndrome, or ACS, and for the treatment of patients with ST-segment elevation myocardial infarction, or STEMI, undergoing primary PCI
|
Cleviprex
|
|
Marketed in the United States; Marketing Authorization Application, or MAA, submitted in European Union countries
|
|
Calcium channel blocker
|
|
Blood pressure reduction when oral therapy is not feasible or not desirable
|
Ready-to-Use Argatroban
|
|
Marketed in the United States
|
|
Direct thrombin inhibitor
|
|
Approved for prophylaxis or treatment of thrombosis in adult patients with HIT and for use as an anticoagulant in adult patients with or at risk for HIT undergoing PCI.
|
Cangrelor
|
|
Phase 3
|
|
Antiplatelet agent
|
|
Prevention of platelet activation and aggregation when oral therapy is not feasible or not desirable
|
Oritavancin
|
|
Phase 3
|
|
Antibiotic
|
|
Treatment of serious gram-positive bacterial infections, including acute bacterial skin and skin structure infections, or ABSSSI and including infections that are resistant to conventional treatment
|
MDCO-157 (IV clopidogrel)
|
|
Pre-registration stage
|
|
Platelet inhibitor
|
|
Platelet inhibition in patients suffering from ACS or patients recently
experiencing myocardial infarction, stroke, or peripheral arterial disease when oral therapy is not feasible or not desirable
|
MDCO-2010
|
|
Phase 2
|
|
Serine protease inhibitor
|
|
Reduction of blood loss during surgery
|
MDCO-216
|
|
Phase 1
|
|
Naturally occurring variant of a protein found in high-density lipoprotein, or HDL
|
|
Reversal cholesterol transport agent to reduce atherosclerotic plaque burden development and thereby reduce the risk of adverse thrombotic events
|
|
Three Months Ended September 30,
|
|||||||||||||
|
2011
|
|
2010
|
|
Change
$
|
|
Change
%
|
|||||||
|
|
|
(in thousands)
|
|
|
|
|
|||||||
U.S. sales
|
$
|
111,561
|
|
|
$
|
100,234
|
|
|
$
|
11,327
|
|
|
11.3
|
%
|
International net revenue
|
9,212
|
|
|
5,509
|
|
|
3,703
|
|
|
67.2
|
%
|
|||
Total net revenue
|
$
|
120,773
|
|
|
$
|
105,743
|
|
|
$
|
15,030
|
|
|
14.2
|
%
|
|
Nine Months Ended September 30,
|
|||||||||||||
|
2011
|
|
2010
|
|
Change
$
|
|
Change
%
|
|||||||
|
|
|
(in thousands)
|
|
|
|
|
|||||||
U.S. sales
|
$
|
328,849
|
|
|
$
|
301,065
|
|
|
$
|
27,784
|
|
|
9.2
|
%
|
International net revenue
|
23,652
|
|
|
16,901
|
|
|
6,751
|
|
|
39.9
|
%
|
|||
Total net revenue
|
$
|
352,501
|
|
|
$
|
317,966
|
|
|
$
|
34,535
|
|
|
10.9
|
%
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||||||||||||||
|
2011
|
|
% of Total
|
|
2010
|
|
% of Total
|
|
2011
|
|
% of Total
|
|
2010
|
|
% of Total
|
||||||||||||
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
|
|
|
(in thousands)
|
||||||||||||
Manufacturing
|
$
|
6,737
|
|
|
17
|
%
|
|
$
|
7,277
|
|
|
23
|
%
|
|
$
|
22,413
|
|
|
20
|
%
|
|
$
|
21,645
|
|
|
23
|
%
|
Royalty
|
27,958
|
|
|
71
|
%
|
|
21,129
|
|
|
67
|
%
|
|
$
|
79,196
|
|
|
70
|
%
|
|
$
|
63,004
|
|
|
67
|
%
|
||
Logistics
|
4,764
|
|
|
12
|
%
|
|
3,162
|
|
|
10
|
%
|
|
$
|
11,250
|
|
|
10
|
%
|
|
$
|
9,256
|
|
|
10
|
%
|
||
Total cost of revenue
|
$
|
39,459
|
|
|
100
|
%
|
|
$
|
31,568
|
|
|
100
|
%
|
|
$
|
112,859
|
|
|
100
|
%
|
|
$
|
93,905
|
|
|
100
|
%
|
|
Three Months Ended September 30,
|
||||||||||||
|
2011
|
|
% of
Total R&D
|
|
2010
|
|
% of
Total R&D
|
||||||
|
(In thousands)
|
|
|
|
(In thousands)
|
|
|
||||||
Angiomax
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
$
|
1,116
|
|
|
4
|
%
|
|
$
|
1,781
|
|
|
11
|
%
|
Manufacturing development
|
34
|
|
|
—
|
%
|
|
622
|
|
|
4
|
%
|
||
Administrative and headcount costs
|
768
|
|
|
3
|
%
|
|
417
|
|
|
2
|
%
|
||
Total Angiomax
|
1,918
|
|
|
7
|
%
|
|
2,820
|
|
|
17
|
%
|
||
Cleviprex
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
659
|
|
|
2
|
%
|
|
229
|
|
|
1
|
%
|
||
Manufacturing development
|
109
|
|
|
—
|
%
|
|
488
|
|
|
3
|
%
|
||
Administrative and headcount costs
|
450
|
|
|
2
|
%
|
|
521
|
|
|
3
|
%
|
||
Total Cleviprex
|
1,218
|
|
|
4
|
%
|
|
1,238
|
|
|
7
|
%
|
||
Cangrelor
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
6,622
|
|
|
25
|
%
|
|
1,611
|
|
|
10
|
%
|
||
Manufacturing development
|
320
|
|
|
1
|
%
|
|
763
|
|
|
5
|
%
|
||
Administrative and headcount costs
|
1,466
|
|
|
6
|
%
|
|
1,082
|
|
|
6
|
%
|
||
Milestone
|
—
|
|
|
—
|
%
|
|
—
|
|
|
—
|
%
|
||
Total Cangrelor
|
8,408
|
|
|
32
|
%
|
|
3,456
|
|
|
21
|
%
|
||
Oritavancin
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
6,038
|
|
|
23
|
%
|
|
1,186
|
|
|
7
|
%
|
||
Manufacturing development
|
925
|
|
|
3
|
%
|
|
383
|
|
|
3
|
%
|
||
Administrative and headcount costs
|
1,153
|
|
|
4
|
%
|
|
2,034
|
|
|
12
|
%
|
||
Total Oritavancin
|
8,116
|
|
|
30
|
%
|
|
3,603
|
|
|
22
|
%
|
||
MDCO-2010
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
73
|
|
|
—
|
%
|
|
861
|
|
|
5
|
%
|
||
Manufacturing development
|
97
|
|
|
—
|
%
|
|
575
|
|
|
3
|
%
|
||
Administrative and headcount costs
|
2,081
|
|
|
8
|
%
|
|
1,077
|
|
|
7
|
%
|
||
Government subsidy
|
—
|
|
|
—
|
%
|
|
(530
|
)
|
|
(3
|
)%
|
||
Total MDCO-2010
|
2,251
|
|
|
8
|
%
|
|
1,983
|
|
|
12
|
%
|
||
MDCO-216
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
102
|
|
|
—
|
%
|
|
86
|
|
|
—
|
%
|
||
Manufacturing development
|
612
|
|
|
2
|
%
|
|
655
|
|
|
4
|
%
|
||
Administrative and headcount costs
|
267
|
|
|
1
|
%
|
|
121
|
|
|
1
|
%
|
||
Total MDCO-216
|
981
|
|
|
3
|
%
|
|
862
|
|
|
5
|
%
|
||
Ready-to-Use Argatroban
|
|
|
|
|
|
|
|
||||||
Manufacturing development
|
—
|
|
|
—
|
%
|
|
139
|
|
|
1
|
%
|
||
Administrative and headcount costs
|
(147
|
)
|
|
(1
|
)%
|
|
—
|
|
|
—
|
%
|
||
Total Ready-to-Use Argatroban
|
(147
|
)
|
|
(1
|
)%
|
|
139
|
|
|
1
|
%
|
||
MDCO-157
|
|
|
|
|
|
|
|
||||||
Administrative and headcount costs
|
35
|
|
|
—
|
%
|
|
—
|
|
|
—
|
%
|
||
Acquisition license fee
|
—
|
|
|
—
|
%
|
|
—
|
|
|
—
|
%
|
||
Total MDCO-157
|
35
|
|
|
—
|
%
|
|
—
|
|
|
—
|
%
|
||
Other
|
3,770
|
|
|
14
|
%
|
|
2,575
|
|
|
15
|
%
|
||
Total
|
$
|
26,550
|
|
|
97
|
%
|
|
$
|
16,676
|
|
|
100
|
%
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2011
|
|
% of
Total R&D
|
|
2010
|
|
% of
Total R&D
|
||||||
|
(In thousands)
|
|
|
|
(In thousands)
|
|
|
||||||
Angiomax
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
$
|
4,763
|
|
|
6
|
%
|
|
$
|
5,080
|
|
|
9
|
%
|
Manufacturing development
|
206
|
|
|
—
|
%
|
|
4,596
|
|
|
9
|
%
|
||
Administrative and headcount costs
|
2,194
|
|
|
3
|
%
|
|
1,824
|
|
|
3
|
%
|
||
Total Angiomax
|
7,163
|
|
|
9
|
%
|
|
11,500
|
|
|
21
|
%
|
||
Cleviprex
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
1,332
|
|
|
2
|
%
|
|
1,316
|
|
|
3
|
%
|
||
Manufacturing development
|
300
|
|
|
1
|
%
|
|
1,209
|
|
|
2
|
%
|
||
Administrative and headcount costs
|
1,095
|
|
|
1
|
%
|
|
1,610
|
|
|
3
|
%
|
||
Total Cleviprex
|
2,727
|
|
|
4
|
%
|
|
4,135
|
|
|
8
|
%
|
||
Cangrelor
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
17,648
|
|
|
23
|
%
|
|
4,964
|
|
|
9
|
%
|
||
Manufacturing development
|
868
|
|
|
1
|
%
|
|
1,724
|
|
|
3
|
%
|
||
Administrative and headcount costs
|
4,741
|
|
|
6
|
%
|
|
3,094
|
|
|
6
|
%
|
||
Milestone
|
—
|
|
|
—
|
%
|
|
3,000
|
|
|
6
|
%
|
||
Total Cangrelor
|
23,257
|
|
|
30
|
%
|
|
12,782
|
|
|
24
|
%
|
||
Oritavancin
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
17,678
|
|
|
23
|
%
|
|
2,250
|
|
|
4
|
%
|
||
Manufacturing development
|
1,825
|
|
|
2
|
%
|
|
2,833
|
|
|
5
|
%
|
||
Administrative and headcount costs
|
3,860
|
|
|
5
|
%
|
|
5,728
|
|
|
11
|
%
|
||
Total Oritavancin
|
23,363
|
|
|
30
|
%
|
|
10,811
|
|
|
20
|
%
|
||
MDCO-2010
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
531
|
|
|
1
|
%
|
|
1,516
|
|
|
3
|
%
|
||
Manufacturing development
|
199
|
|
|
—
|
%
|
|
946
|
|
|
2
|
%
|
||
Administrative and headcount costs
|
3,867
|
|
|
5
|
%
|
|
3,151
|
|
|
6
|
%
|
||
Government subsidy
|
(222
|
)
|
|
—
|
%
|
|
(1,038
|
)
|
|
(2
|
)%
|
||
Total MDCO-2010
|
4,375
|
|
|
6
|
%
|
|
4,575
|
|
|
9
|
%
|
||
MDCO-216
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
588
|
|
|
1
|
%
|
|
126
|
|
|
—
|
%
|
||
Manufacturing development
|
2,025
|
|
|
3
|
%
|
|
1,246
|
|
|
2
|
%
|
||
Administrative and headcount costs
|
749
|
|
|
1
|
%
|
|
430
|
|
|
1
|
%
|
||
Total MDCO-216
|
3,362
|
|
|
5
|
%
|
|
1,802
|
|
|
3
|
%
|
||
Ready-to-Use Argatroban
|
|
|
|
|
|
|
|
||||||
Manufacturing development
|
—
|
|
|
—
|
%
|
|
616
|
|
|
1
|
%
|
||
Administrative and headcount costs
|
544
|
|
|
1
|
%
|
|
169
|
|
|
—
|
%
|
||
Total Ready-to-Use Argatroban
|
544
|
|
|
1
|
%
|
|
785
|
|
|
1
|
%
|
||
MDCO-157
|
|
|
|
|
|
|
|
||||||
Administrative and headcount costs
|
35
|
|
|
—
|
%
|
|
—
|
|
|
—
|
%
|
||
Acquisition license fee
|
1,750
|
|
|
2
|
%
|
|
—
|
|
|
—
|
%
|
||
Total MDCO-157
|
1,785
|
|
|
2
|
%
|
|
—
|
|
|
—
|
%
|
||
Other
|
10,302
|
|
|
13
|
%
|
|
7,738
|
|
|
14
|
%
|
||
Total
|
$
|
76,878
|
|
|
100
|
%
|
|
$
|
54,128
|
|
|
100
|
%
|
•
|
the scope, rate of progress and cost of our clinical trials and other research and development activities;
|
•
|
future clinical trial results;
|
•
|
the terms and timing of any collaborative, licensing and other arrangements that we may establish;
|
•
|
the cost and timing of regulatory approvals;
|
•
|
the cost and timing of establishing and maintaining sales, marketing and distribution capabilities;
|
•
|
the cost of establishing and maintaining clinical and commercial supplies of our products and product candidates;
|
•
|
the effect of competing technological and market developments; and
|
•
|
the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights.
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||||||||||||||||
|
2011
|
|
2010
|
|
Change $
|
|
Change %
|
|
2011
|
|
2010
|
|
Change $
|
|
Change %
|
||||||||||||||
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||||||||||||
Selling, general and administrative expenses
|
$
|
45,353
|
|
|
$
|
35,788
|
|
|
$
|
9,565
|
|
|
26.7
|
%
|
|
$
|
124,701
|
|
|
$
|
121,318
|
|
|
$
|
3,383
|
|
|
2.8
|
%
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||||||||||||||||
|
2011
|
|
2010
|
|
Change $
|
|
Change %
|
|
2011
|
|
2010
|
|
Change $
|
|
Change %
|
||||||||||||||
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||||||||||||
Legal settlement
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
100.0
|
%
|
|
$
|
17,984
|
|
|
$
|
—
|
|
|
$
|
17,984
|
|
|
100.0
|
%
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||||||||||||||||
|
2011
|
|
2010
|
|
Change $
|
|
Change %
|
|
2011
|
|
2010
|
|
Change $
|
|
Change %
|
||||||||||||||
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||||||||||||
Other income
|
$
|
578
|
|
|
$
|
483
|
|
|
$
|
95
|
|
|
19.7
|
%
|
|
$
|
1,450
|
|
|
$
|
55
|
|
|
$
|
1,395
|
|
|
2,536.4
|
%
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||||||||||||||||
|
2011
|
|
2010
|
|
Change $
|
|
Change %
|
|
2011
|
|
2010
|
|
Change $
|
|
Change %
|
||||||||||||||
|
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||
Provision for income tax
|
$
|
62,625
|
|
|
$
|
(989
|
)
|
|
$
|
63,614
|
|
|
(6,432.2
|
)%
|
|
$
|
50,798
|
|
|
$
|
(2,607
|
)
|
|
$
|
53,405
|
|
|
(2,048.5
|
)%
|
•
|
on September 16, 2011, President Obama signed the Leahy-Smith America Invents Act, which clarified the filing timeline for patent term extension applications under the Hatch-Waxman Act. This clarification confirmed the interpretation of the Hatch-Waxman Act adopted by the federal district court's August 3, 2010 decision in our suit against the PTO, the
|
•
|
on September 30, 2011, we entered into a settlement agreement and a license agreement with Teva, with respect to our patent infringement suits against Teva, which includes our suit against Pliva Hrvatska d.o.o., et al. As part of the settlement agreement, Teva admitted that the '727 patent and '343 patent are valid and enforceable and that they would be infringed by the manufacture and sale of Teva's generic bivalirudin for injection products. Under the license agreement, we granted Teva a non-exclusive license under the'727 patent and '343 patent to sell a generic bivalirudin for injection product under a Teva ANDA in the United States beginning June 30, 2019 or earlier under certain conditions. The '727 patent and '343 patent are listed in the Orange Book and expire on July 27, 2028;
|
•
|
for 2010 and the nine months ended September 30, 2011, our reported U.S. income before income taxes totaled approximately $80.8 million and $57.9 million, respectively; and
|
•
|
we launched our third product, ready-to-use Argatroban, in the United States in September 2011.
|
•
|
APP filed a motion to intervene for the purpose of appeal in our case against the PTO, the FDA and HHS. On September 13, 2010, the federal district court denied APP's motion. APP has appealed the denial of its motion, as well as the federal district court's August 3, 2010 order (and all related and underlying orders). This appeal is pending in the U.S. Court of Appeals for the Federal Circuit. In its appeal, APP is contending that Section 37 of the America Invents Act does not govern our matter and is challenging the constitutionality of the America Invents Act. On September 27, 2011, APP filed for a Motion for Stay Pending Appeal in order to prevent the PTO from issuing a final certificate of extension for the '404 patent.
|
•
|
we were, and currently are, involved in patent infringement litigation with four generic manufacturers with respect to our '343 and '727 patents, the negative outcomes of which may have a material impact on our future operations and profitability.
|
•
|
the extent to which Angiomax is commercially successful globally;
|
•
|
our ability to maintain market exclusivity for Angiomax in the United States through at least June 2015, which could be adversely affected as a result of an adverse court decision or adverse legislation relating to the '404 patent;
|
•
|
our ability to maintain market exclusivity for Angiomax in the United States through June 30, 2019, the date on which we agreed Teva may sell a generic version of Angiomax, through the enforcement of our other U.S. patents covering
|
•
|
the terms of any settlements with Biogen Idec, HRI or the law firm with which we have not settled our claims with respect to the '404 patent and the PTO's initial denial of our application to extend the term of the patent;
|
•
|
the extent to which Cleviprex and ready-to-use Argatroban are commercially successful in the United States;
|
•
|
the extent to which we can successfully establish a commercial infrastructure outside the United States;
|
•
|
the consideration paid by us in connection with acquisitions and licenses of development-stage compounds, clinical stage product candidates, approved products, or businesses, and in connection with other strategic arrangements;
|
•
|
the progress, level, timing and cost of our research and development activities related to our clinical trials and non-clinical studies with respect to Angiomax and Cleviprex, as well as cangrelor, oritavancin and MDCO-157 and our other products in development;
|
•
|
the cost and outcomes of regulatory submissions and reviews for approval of Angiomax in additional countries and for additional indications, of Cleviprex outside the United States, Australia, New Zealand and Switzerland and of our products in development globally;
|
•
|
the continuation or termination of third-party manufacturing, distribution and sales and marketing arrangements;
|
•
|
the size, cost and effectiveness of our sales and marketing programs globally;
|
•
|
the amounts of our payment obligations to third parties as to our products and products in development; and
|
•
|
our ability to defend and enforce our intellectual property rights.
|
Contractual Obligations (in thousands)
|
Total
|
|
2011 Q4
|
|
2012-2013
|
|
2014-2015
|
|
After 2015
|
||||||||||
|
(in thousands)
|
||||||||||||||||||
Inventory related commitments
|
$
|
126,161
|
|
|
$
|
23,884
|
|
|
$
|
87,277
|
|
|
$
|
15,000
|
|
|
$
|
—
|
|
•
|
the nature of the estimate or assumption is material due to the level of subjectivity and judgment necessary to account for highly uncertain matters or the susceptibility of such matters to change; and
|
•
|
the impact of the estimates and assumptions on financial condition or operating performance is material.
|
•
|
our ability to maintain market exclusivity for Angiomax in the United States through at least June 2015, which could be adversely affected as a result of an adverse court decision or adverse legislation relating to the '404 patent;
|
•
|
our ability to maintain market exclusivity for Angiomax in the United States through June 30, 2019, the date on which we agreed Teva may sell a generic version of Angiomax, through the enforcement of our other U.S. patents covering Angiomax;
|
•
|
the continued acceptance by regulators, physicians, patients and other key decision-makers of Angiomax as a safe, therapeutic and cost-effective alternative to heparin and other products used in current practice or currently being developed;
|
•
|
our ability to further develop Angiomax and obtain marketing approval of Angiomax for use in additional patient populations and the clinical data we generate to support expansion of the product label;
|
•
|
the overall number of PCI procedures performed;
|
•
|
the ability of our third-party supply and manufacturing partners to provide us with sufficient quantities of Angiomax;
|
•
|
the impact of competition from existing competitive products and from competitive products that may be approved in the future;
|
•
|
the continued safety and efficacy of Angiomax;
|
•
|
to what extent and in what amount government and third-party payors cover or reimburse for the costs of Angiomax; and
|
•
|
our success and the success of our international distributors in selling and marketing Angiomax in Europe and in other countries outside the United States.
|
•
|
the extent to which Angiomax is commercially successful globally;
|
•
|
our ability to maintain market exclusivity for Angiomax in the United States through at least June 2015, which could be adversely affected as a result of an adverse court decision or adverse legislation relating to the '404 patent;
|
•
|
our ability to maintain market exclusivity for Angiomax in the United States through June 30, 2019, the date on which we agreed Teva may sell a generic version of Angiomax, through the enforcement of our other U.S. patents covering Angiomax;
|
•
|
the terms of any settlements with Biogen Idec, HRI or the law firm with which we have not settled our claims with respect to the '404 patent and the PTO's initial denial of our application to extend the term of the patent;
|
•
|
the extent to which Cleviprex and ready-to-use Argatroban are commercially successful in the United States;
|
•
|
the extent to which we can successfully establish a commercial infrastructure outside the United States;
|
•
|
the consideration paid by us in connection with acquisitions and licenses of development-stage compounds, clinical-stage product candidates, approved products, or businesses, and in connection with other strategic arrangements;
|
•
|
the progress, level, timing and cost of our research and development activities related to our clinical trials and non-clinical studies with respect to Angiomax, Cleviprex, as well as cangrelor, oritavancin and MDCO-157 and our other products in development;
|
•
|
the cost and outcomes of regulatory submissions and reviews for approval of Angiomax in additional countries and for additional indications, of Cleviprex outside the United States, Australia, New Zealand and Switzerland and of our products in development globally;
|
•
|
the continuation or termination of third-party manufacturing, distribution and sales and marketing arrangements;
|
•
|
the size, cost and effectiveness of our sales and marketing programs globally;
|
•
|
the amounts of our payment obligations to third parties as to our products and products in development; and
|
•
|
our ability to defend and enforce our intellectual property rights.
|
•
|
continue to improve operating, administrative, and information systems;
|
•
|
accurately predict future personnel and resource needs to meet contract commitments;
|
•
|
track the progress of ongoing projects; and
|
•
|
attract and retain qualified management, sales, professional, scientific and technical operating personnel.
|
•
|
political and economic determinations that adversely impact pricing or reimbursement policies;
|
•
|
our customers' ability to obtain reimbursement for procedures using our products in foreign markets;
|
•
|
compliance with complex and changing foreign legal, tax, accounting and regulatory requirements;
|
•
|
language barriers and other difficulties in providing long-range customer support and service;
|
•
|
longer accounts receivable collection times;
|
•
|
significant foreign currency fluctuations, which could result in increased operating expenses and reduced revenues;
|
•
|
trade restrictions and restrictions on direct investment by foreign entities;
|
•
|
reduced protection of intellectual property rights in some foreign countries; and
|
•
|
the interpretation of contractual provisions governed by foreign laws in the event of a contract dispute.
|
•
|
delay or otherwise adversely impact the manufacturing, development or commercialization of our products, our products in development or any additional products or product candidates that we may acquire or develop;
|
•
|
require us to seek a new collaborator or undertake unforeseen additional responsibilities or devote unforeseen additional resources to the manufacturing, development or commercialization of our products; or
|
•
|
result in the termination of the development or commercialization of our products.
|
•
|
reliance on the third party for regulatory compliance and quality assurance;
|
•
|
the possible breach of the manufacturing agreement by the third party; and
|
•
|
the possible termination or nonrenewal of the agreement by the third party, based on its own business priorities, at a time that is costly or inconvenient for us.
|
•
|
delay or prevent the successful commercialization of any of the products or product candidates in the jurisdiction for which approval is sought;
|
•
|
diminish our competitive advantage; and
|
•
|
defer or decrease our receipt of revenue.
|
•
|
our clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials which even if undertaken cannot ensure we will gain approval;
|
•
|
data obtained from pre-clinical testing and clinical trials may be subject to varying interpretations, which could result in the FDA or other regulatory authorities deciding not to approve a product in a timely fashion, or at all;
|
•
|
the cost of clinical trials may be greater than we currently anticipate;
|
•
|
regulators or institutional review boards may not authorize us to commence a clinical trial or conduct a clinical trial at a prospective trial site;
|
•
|
we, or the FDA or other regulatory authorities, might suspend or terminate a clinical trial at any time on various grounds, including a finding that participating patients are being exposed to unacceptable health risks. For example, we have in the past voluntarily suspended enrollment in one of our clinical trials to review an interim analysis of safety data from the trial; and
|
•
|
the effects of our product candidates may not be the desired effects or may include undesirable side effects or the product candidates may have other unexpected characteristics.
|
•
|
delay in approving or refusal to approve a product;
|
•
|
product recall or seizure;
|
•
|
suspension or withdrawal of an approved product from the market;
|
•
|
delays in, suspension of or prohibition of commencing, clinical trials of products in development;
|
•
|
interruption of production;
|
•
|
operating restrictions;
|
•
|
untitled or warning letters;
|
•
|
injunctions;
|
•
|
fines and other monetary penalties;
|
•
|
the imposition of civil or criminal penalties;
|
•
|
disruption of importing and exporting activities; and
|
•
|
unanticipated expenditures.
|
•
|
the Federal Anti-Kickback Law, which prohibits persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce either the referral of an individual or furnishing or arranging for a good or service for which payment may be made under federal health care programs such as Medicare and Medicaid;
|
•
|
other Medicare laws and regulations that prescribe the requirements for coverage and payment for services performed by our customers, including the amount of such payment;
|
•
|
the Federal False Claims Act, which imposes civil and criminal liability on individuals and entities who submit, or cause to be submitted, false or fraudulent claims for payment to the government;
|
•
|
the Federal False Statements Act, which prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with delivery of or payment for health care benefits, items or services; and
|
•
|
various state laws that impose similar requirements and liability with respect to state healthcare reimbursement and other programs.
|
•
|
obtain and maintain U.S. and foreign patents, including defending those patents against adverse claims;
|
•
|
secure patent term extension for the patents covering our approved products;
|
•
|
protect trade secrets;
|
•
|
operate without infringing the proprietary rights of others; and
|
•
|
prevent others from infringing our proprietary rights.
|
•
|
achievement or rejection of regulatory approvals of our product candidates and our products;
|
•
|
regulatory actions by the FDA or a foreign jurisdiction limiting or revoking the use of our products;
|
•
|
changes in securities analysts' estimates of our financial performance;
|
•
|
changes in valuations of similar companies;
|
•
|
variations in our operating results;
|
•
|
acquisitions and strategic partnerships;
|
•
|
announcements of technological innovations or new commercial products by us or our competitors or the filing of ANDAs or NDAs for products competitive with ours;
|
•
|
disclosure of results of clinical testing or regulatory proceedings by us or our competitors;
|
•
|
the timing, amount and receipt of revenue from sales of our products and margins on sales of our products;
|
•
|
changes in governmental regulations;
|
•
|
developments in patent rights or other proprietary rights, particularly with respect to our U.S. Angiomax patents;
|
•
|
the extent to which Angiomax is commercially successful globally;
|
•
|
our ability to maintain market exclusivity for Angiomax in the United States through at least June 2015, which could be adversely affected as a result of an adverse court decision or adverse legislation relating to the '404 patent;
|
•
|
our ability to maintain market exclusivity for Angiomax in the United States through June 30, 2019, the date on which we agreed Teva may sell a generic version of Angiomax, through the enforcement of our U.S. patents covering Angiomax;
|
•
|
our ability to maintain our market exclusivity for Angiomax in the United States, which would be adversely affected as a result of an adverse court decision or adverse legislation relating to the '404 patent or our inability to enforcement of our other U.S. patents covering Angiomax;
|
•
|
significant new litigation;
|
•
|
developments or issues with our contract manufacturers;
|
•
|
changes in our management; and
|
•
|
general market conditions.
|
•
|
Section 203 of the Delaware General Corporation Law, which provides that we may not enter into a business combination with an interested stockholder for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in the manner prescribed in Section 203;
|
•
|
our board of directors has the authority to issue, without a vote or action of stockholders, up to 5,000,000 shares of a new series of preferred stock and to fix the price, rights, preferences and privileges of those shares, each of which could be superior to the rights of holders of our common stock;
|
•
|
our directors are elected to staggered terms, which prevents our entire board of directors from being replaced in any single year;
|
•
|
our directors may be removed only for cause and then only by the affirmative vote of the holders of at least 75% of the votes which all stockholders would be entitled to cast in any annual election of directors;
|
•
|
the size of our board of directors is determined by resolution of the board of directors;
|
•
|
any vacancy on our board of directors, however occurring, including a vacancy resulting from an enlargement of our board, may only be filled by vote of a majority of our directors then in office, even if less than a quorum;
|
•
|
only our board of directors, the chairman of the board or our president may call special meetings of stockholders;
|
•
|
our by-laws may be amended, altered or repealed by (i) the affirmative vote of a majority of our directors, subject to any limitations set forth in the by-laws, or (ii) the affirmative vote of the holders of at least 75% of the votes which all the stockholders would be entitled to cast in any annual election of directors;
|
•
|
stockholders must provide us with advance notice, and certain information specified in our by-laws, in connection with nominations or proposals by such stockholder for consideration at an annual meeting;
|
•
|
stockholders may not take any action by written consent in lieu of a meeting; and
|
•
|
our certificate of incorporation may only be amended or repealed by the affirmative vote of a majority of our directors and the affirmative vote of the holders of at least 75% of the votes which all the stockholders would be entitled to cast in any annual election of directors (and plus any separate class vote that might in the future be required pursuant to the terms of any series of preferred stock that might be outstanding at the time any of these amendments are submitted to stockholders).
|
•
|
responding to proxy contests and other actions by activist shareholders may be costly and time-consuming and may disrupt our operations and divert the attention of management and our employees;
|
•
|
perceived uncertainties as to our future direction may result in our inability to consummate potential acquisitions, collaborations or in-licensing opportunities and may make it more difficult to attract and retain qualified personnel and business partners; and
|
•
|
if individuals are elected to our board of directors with a specific agenda different from ours, it may adversely affect our ability to effectively and timely implement our strategic plan and create additional value for our stockholders.
|
Date:
|
November 9, 2011
|
|
By:
|
/s/ Glenn P. Sblendorio
|
|
|
|
|
Glenn P. Sblendorio
|
|
|
|
|
Executive Vice President and Chief Financial
|
|
|
|
|
Officer (Principal Financial and Accounting Officer)
|
Exhibit Number
|
|
Description
|
10.1*
|
|
Manufacturing Services Agreement, dated March 30, 2011, between registrant and Patheon International A.G.
|
|
|
|
10.2*
|
|
Settlement Agreement, dated September 30, 2011, between registrant and Teva Pharmaceuticals USA, Inc.
|
|
|
|
10.3*
|
|
License Agreement, dated September 30, 2011, between registrant and Teva Pharmaceuticals USA, Inc.
|
|
|
|
10.4*
|
|
Supply Agreement, dated September 30, 2011, between registrant and Plantex USA Inc.
|
|
|
|
10.5*
|
|
First Amendment to the Second Amended and Restated Distribution Agreement, dated July 1, 2011, between registrant and Integrated Commercial Solutions, Inc.
|
|
|
|
10.6*
|
|
Second Amendment to the Second Amended and Restated Distribution Agreement, dated July 1, 2011, between registrant and Integrated Commercial Solutions, Inc.
|
|
|
|
31.1
|
|
Chairman and Chief Executive Officer Certification pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
|
31.2
|
|
Chief Financial Officer Certification pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
|
32.1
|
|
Chairman and Chief Executive Officer Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
|
32.2
|
|
Chief Financial Officer Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
|
101
|
|
The following materials from The Medicines Company Quarterly Report on Form 10-Q for the quarter ended September 30, 2011, formatted in XBRL (Extensible Business Reporting Language): (i) the Consolidated Balance Sheet, (ii) the Consolidated Statement of Operations, (iii) the Consolidated Statement of Cash Flow, and (iv) Notes to Consolidated Financial Statements.
|
ARTICLE 1
|
INTERPRETATION 1
|
1.1
|
Definitions. 1
|
1.2
|
Currency. 5
|
1.3
|
Sections and Headings. 5
|
1.4
|
Singular Terms. 5
|
1.5
|
Schedules. 5
|
ARTICLE 2
|
PATHEON’S MANUFACTURING SERVICES 6
|
2.1
|
Technology Transfer and Feasibility Activities. 6
|
2.2
|
Manufacturing Services. 6
|
2.3
|
Standard of Performance. 7
|
2.4
|
Subcontractors. 7
|
ARTICLE 3
|
MDCO’S OBLIGATIONS 7
|
3.1
|
Payment. 7
|
3.2
|
Active Materials. 8
|
ARTICLE 4
|
CONVERSION FEES AND COMPONENT COSTS 8
|
4.1
|
First Year Pricing. 8
|
4.2
|
Price Adjustments. 8
|
4.2.1 Adjustment due to Volume Changes from Yearly Binding Volumes
|
9
|
4.3
|
Adjustments Due to Technical Changes. 10
|
ARTICLE 5
|
ORDERS, SHIPMENT, INVOICING, PAYMENT 10
|
5.1
|
Orders and Forecasts. 10
|
5.2
|
Reliance by Patheon. 11
|
5.3
|
Minimum Orders. 12
|
5.4
|
Shipments. 12
|
5.5
|
Invoices and Payment. 12
|
ARTICLE 6
|
PRODUCT CLAIMS AND RECALLS 12
|
6.1
|
Product Claims. 12
|
6.2
|
Patheon’s Responsibility for Defective and Recalled Products. 13
|
6.3
|
Disposition of Defective or Recalled Products. 14
|
6.4
|
Healthcare Provider or Patient Questions and Complaints. 14
|
6.5
|
Sole Remedy. 14
|
ARTICLE 7
|
CO-OPERATION 14
|
7.1
|
Quarterly Review. 14
|
7.2
|
Access & Audits. 14
|
7.3
|
Reports. 15
|
7.4
|
Regulatory Authority Filings. 15
|
ARTICLE 8
|
TERM AND TERMINATION 15
|
8.1
|
Initial Term. 15
|
8.2
|
Termination for Cause. 15
|
8.3
|
Product Discontinuation. 16
|
8.4
|
Obligations on Termination. 16
|
ARTICLE 9
|
REPRESENTATIONS, WARRANTIES AND COVENANTS 17
|
9.1
|
Authority. 17
|
9.2
|
MDCO Warranties. 17
|
9.3
|
Patheon Warranties. 17
|
9.4
|
Debarred Persons. 18
|
9.5
|
No Warranty. 19
|
ARTICLE 10
|
REMEDIES AND INDEMNITIES 19
|
10.1
|
Consequential Damages. 19
|
10.2
|
Limitation of Liability-Active Materials. 19
|
10.3
|
Patheon. 19
|
10.4
|
MDCO. 19
|
10.5
|
Reasonable Allocation of Risk. 20
|
ARTICLE 11
|
CONFIDENTIALITY 20
|
11.1
|
Confidential Information - Disclosing Party’s Property. 20
|
11.2
|
Receiving Party’s Obligations. 20
|
11.3
|
Allowable Disclosures. 21
|
11.4
|
Exclusions. 21
|
11.5
|
Continuing Obligations of Confidentiality. 21
|
ARTICLE 12
|
DISPUTE RESOLUTION 22
|
12.1
|
Commercial Disputes. 22
|
12.2
|
Technical Dispute Resolution. 22
|
ARTICLE 13
|
MISCELLANEOUS 22
|
13.1
|
Inventions. 22
|
13.2
|
Intellectual Property. 23
|
13.3
|
Insurance. 23
|
13.4
|
Independent Contractors. 23
|
13.5
|
No Waiver. 24
|
13.6
|
Assignment and Subcontracting. 24
|
13.7
|
Force Majeure. 24
|
13.8
|
Additional Product. 24
|
13.9
|
Notices. 24
|
13.10
|
Severability. 25
|
13.11
|
Entire Agreement. 25
|
13.12
|
Other Terms. 26
|
13.13
|
No Third Party Benefit or Right. 26
|
13.14
|
Execution in Counterparts. 26
|
13.15
|
Use of MDCO Name. 26
|
13.16
|
Governing Law. 26
|
•
|
Parts 210 and 211 of Title 21 of the United Slates’ Code of Federal Regulations; and
|
•
|
EC Directive 2003/94/EC;
|
a)
|
Conversion of Active Materials and Components
. Patheon shall convert Active Materials and Components into Products.
|
b)
|
Quality Control and Quality Assurance
. Patheon shall perform the quality control and quality assurance testing specified in the Quality Agreement.
|
c)
|
Components
. Patheon shall purchase and test all Components (with the exception of those that are supplied by MDCO) as specified by the Specifications and per the Quality Agreement.
|
d)
|
Stability Testing
. Patheon shall conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods specified in Schedule C.
|
e)
|
Product Rejection for Finished Product Specification Failure
. If Patheon performs the Manufacturing Services in accordance with the Manufacturing Requirements and, notwithstanding the foregoing, a batch or portion of batch of Product does not meet Specification, MDCO shall be obligated to pay Patheon the applicable fee per unit for such non-conforming Product. However, if the non-conforming Product results from Patheon’s failure to perform the Manufacturing Services in accordance with the Manufacturing Requirements, then MDCO shall not be required to pay Patheon the applicable fee per unit for such non-conforming product. This absolution of MDCO’s obligation to pay Patheon’s production fees shall be in addition to Patheon’s compensation to MDCO provided in section 10.2 for the loss of Active Materials.
|
f)
|
Active Materials and MDCO Supplied Components Importing
. At least thirty (30) days prior to the scheduled production date, MDC shall furnish to Patheon, DDP
|
g)
|
Bill Back Items
. Bill Back Items (if any) shall be charged to MDCO at Patheon’s cost plus the agreed upon handling fee of [**]% subject to a maximum handling fee of €[**] per item. Should the handling fees exceed the amount of €[**] per item, the Parties will jointly determine, in good faith, the revised aggregate amount payable by MDCO.
|
4.2.1
|
Adjustment due to Volume Changes from Yearly Binding Volumes
|
(a)
|
On the execution of this Agreement, MDCO shall provide Patheon with its best estimate of the volume of Product that MDCO will require Patheon to supply during the Term of this Agreement (such forecast to be known as the “
Long Term Forecast
”), starting from January 1, 2012. This Long Term Forecast is provided in Schedule B. The volumes of Product forecasted in the Long Term Forecast snail not be deemed as binding on MDCO.
|
(b)
|
Prior to July 1
st
of each Year during the Term, MDCO will provide Patheon with a firm volume commitment for the immediately following Year (the “
Yearly Binding Volume
” or “
YBV
”).
|
(c)
|
Notwithstanding the foregoing Section 4.2.1(b), the Parties hereby agree that the Yearly Binding Volume may be reduced yearly during the Term of the Agreement within the flexibility ranges (hereinafter the “Flexibility Ranges” or “FR”) set out in the Table below:
|
YEAR
|
FLEXIBILITY RANGE ON YEARLY BINDING VOLUME
|
2012
|
[**]%
|
2013
|
[**]%
|
2014 and beyond
|
[**]%
|
•
|
Yearly Binding Volume
(or “
YBV
”): means the aggregate yearly
|
|
Actual Yearly Volume
(or “
AYV
”): means the actual total volume of Product ordered by MDCO and invoiced by Patheon pursuant to Section 5.5 during the relevant Year.
|
(d)
|
If during a Year MDCO requests a volume of Product which exceeds by more than [**] percent (+[**]%) the YBV for such Year pursuant to Section 4.2.1(b) above, then the Parties shall evaluate in good faith such request in order to reach an agreement on Product feasibility in the current Year and Patheon shall use all commercially reasonable efforts to meet MDCO’s requests.
|
(a)
|
the Specifications for each of the Products are its or its Affiliate’s property and that MDCO may lawfully disclose the Specifications to Patheon;
|
(b)
|
any Intellectual Property, other than Patheon’s Intellectual Property, utilized by Patheon in connection with the provision of the Manufacturing Services according to the Specifications (i) is MDCO’s or its Affiliate’s Intellectual Property, (ii) may be lawfully used as directed by MDCO, and (iii) to MDCO’s knowledge, such use does not infringe and will not infringe any Third Party Rights;
|
(c)
|
to MDCO’s knowledge, the provision of the Manufacturing Services by Patheon in respect of any Product pursuant to this Agreement or use or other disposition of any Product by Patheon as may be required to perform its obligations under this Agreement does not and will not infringe any Third Party Rights;
|
(d)
|
there are no actions or other legal proceedings, the subject of which is the infringement of Third Party Rights related to: (i.) any of the Specifications, (ii.) any of the Active Materials, (iii.) any of the Components, or (iv.) the sale, use or other disposition of any Product made in accordance with the Specifications;
|
(a)
|
Patheon covenants, represents and warrants that it shall perform the Manufacturing Services in accordance with the Manufacturing Requirements.
|
(b)
|
Patheon covenants, represents and warrants that any Manufacturing Services Based Intellectual Property utilized by Patheon in connection with the provision of the Manufacturing Services (i) is Patheon’s or its Affiliate’s property, (ii) may be lawfully used as used by Patheon, and (iii) to Patheon’s knowledge, such use does not infringe and will not infringe any Third Party Rights.
|
(c)
|
Anti-Bribery
. Patheon represents and warrants that neither Patheon nor its Affiliates, or any of its or their directors, officers, employees or representatives will, directly or indirectly, offer or pay, or authorize an offer or payment of, any money or anything of value to any Public Official
|
(a)
|
use the Confidential Information solely and exclusively for the purposes of this Agreement (or such other purpose as is agreed in writing between the Parties at the time of disclosure), and not to use the Confidential Information for any other purpose whatsoever, including the development, manufacture, marketing, sale or licensing of any process or product or any other commercial purpose anywhere in the world, unless the Parties enter into an agreement specifying otherwise; and
|
(b)
|
maintain the confidentiality of the Confidential Information and not to disclose it directly or indirectly to any other company, organization, individual or third party, except as expressly permitted; and
|
(c)
|
at the request of the Disclosing Party, to return, delete or destroy all copies of the Confidential Information, in whatever form it is held, except one (1) copy which may be kept by the Receiving Party in its secured files for evidence purposes only.
|
(a)
|
Notwithstanding Section 11.2, the Receiving Party may disclose Confidential Information to any of its Affiliates, and its Affiliates’ directors, employees and professional advisers who need to know the Confidential Information in order to fulfill the purpose of this Agreement, provided that the Receiving Party ensures that prior to such disclosure,
|
(b)
|
Nothing in Section 11.2 will preclude disclosure of any Confidential Information required by any governmental, quasi-governmental or regulatory agency or authority or court entitled by Law to disclosure of the same, or which is required by Law or the requirements of a national securities exchange or another similar regulatory body to be disclosed, provided that the Receiving Party promptly notifies the Disclosing Party when such requirement to disclose has arisen to enable the Disclosing Party to seek an appropriate protective order, to make known to the relevant agency, authority, court or securities exchange the proprietary nature of the Confidential Information, and to make any applicable claim of confidentiality. The Receiving Party agrees to co-operate in any action that the Disclosing Party may decide to take. If the Receiving Party is required to make a disclosure in accordance with this clause, it will only make a disclosure to the extent to which it is obliged.
|
(a)
|
was already in the possession of the Receiving Party or any of its Affiliates (through no fault of the Receiving Party or any of its Affiliates and no breach of this Agreement by the Receiving Party) prior to its disclosure by the Disclosing Party under this Agreement;
|
(b)
|
is purchased or otherwise legally acquired by the Receiving Party or any of its Affiliates at any time from a third party having the right to disclose it;
|
(c)
|
comes into the public domain, other than through the fault of the Receiving Party or any of its Affiliates; or
|
(d)
|
is independently generated by the Receiving Party or any of its Affiliates without any recourse or reference to the Confidential Information.
|
(a)
|
For the term of this Agreement, MDCO hereby grants to Patheon and to the Subcontractor a non-exclusive, paid-up, royalty-free, non-transferable license of MDCO’s Intellectual Property which Patheon and the Subcontractor must use solely for the purpose of performing the Manufacturing Services.
|
(b)
|
All Intellectual Property generated or derived by Patheon and/or by the Subcontractor in the course of performing the Manufacturing Services, to the extent it is specific to the development, manufacture, use and sale of MDCO’s Product that is the subject of the Manufacturing Services, shall be the exclusive property of MDCO.
|
(c)
|
All Manufacturing Services Based Intellectual Property generated or derived by Patheon and/or by the Subcontractor in the course of performing the Manufacturing Services shall be the exclusive property of Patheon or of its Subcontractor (as the case may be); Patheon hereby grants to MDCO and (if it is the case) will cause the Subcontractor to grant, a perpetual, irrevocable, non-exclusive, paid-up, royalty-free,
|
(d)
|
Each Party shall be solely responsible for the costs of filing, prosecution and maintenance of patents and patent applications on its own Inventions.
|
(e)
|
Either Party shall give the other Party written notice, as promptly as practicable, of all Inventions which can reasonably be deemed to constitute improvements or other modifications of the Products or processes or technology owned or otherwise controlled by such Party.
|
(a)
|
Neither Party may assign this Agreement or any of its rights or obligations
|
(b)
|
Notwithstanding the foregoing provisions of this Section 13.6, either Party may assign this Agreement to any of its Affiliates or to a successor to or purchaser of all or substantially all of its business, provided that such assignee executes an agreement with the non-assigning Party hereto whereby it agrees to be bound hereunder.
|
PRODUCTS
|
MINIMUM RUN QUANTITY
|
Angiomax®/ Angiox®
|
2 Batches
|
PRODUCTS
|
2012
|
2013
|
2014
|
2015
|
2016
|
Angiomax®/ Angiox®
|
[**] vials
|
[**] vials
|
[**]vials
|
[**] vials
|
[**] vials
|
Product
|
Fill
Volume |
Vial Size
|
Lyo
cycle |
Batch
size proposed |
Annual
Volume |
Unit
Conversion Price (1) |
Unit Total
Price (1) |
Angiomax
®
/
Angiox ® |
5.5 ml
|
ext.Ø
|
~105 hours
|
30,000
vials |
From 1 vial to 400k vials
|
[**] €/vial
|
[**] €/vial
|
23.75 mm
|
More than 400k vials
|
[**] €/vial
|
[**] €/vial
|
Product
|
Fill
Volume |
Vial Size
|
Lyo
cycle |
Batch
size proposed |
Annual
Volume |
Unit
Conversion Price (1) |
Unit Total
Price (1) |
Angiomax
®
/
Angiox ® |
5.5 ml
|
ext.Ø
|
~105 hours
|
~48,000
vials |
From 1 vial to 400k vials
|
[**] €/vial
|
[**] €/vial
|
23.75 mm
|
More than 400k vials
|
[**] €/vial
|
[**] €/vial
|
Active Materials
|
Supplier
|
Bivalirudin
|
Lonza
|
PRODUCT
|
ACTIVE MATERIALS
|
ACTIVE MATERIALS CREDIT VALUE
|
Angiomax® / Angiox®
|
Bivalirudin
|
€ [**] per vial, if loss is to Product or in-process materials in vials
€ [**] per gram, if loss is directly to Active Materials or to in-process production
|
PRODUCT
|
MAXIMUM CREDIT VALUE
|
Angiomax® / Angiox®
|
[**]% of the annual conversion costs invoiced by Patheon and paid by MDCO for the manufacture of Product. during the Year in which the API’s loss occurs.
Final calculation of the Maximum Credit Value will be made following the end of the applicable Year.
|
Section No.
|
Subject/Terms
|
MDCO
|
Patheon
|
4.1 Quality Management
|
|||
4/1/2001
|
GMP,
Health
and Safety Compliance
|
|
X
|
4/1/2002
|
MDCO Audit Rights
|
X
|
|
4/1/2003
|
Subcontracting
|
(X)
|
X
|
4/1/2004
|
Self-Inspection
|
|
X
|
4.2 Regulatory Requirements
|
|||
4/2/2001
|
Licenses, Marketing Authorizations and Permits
|
X
|
X
|
4/2/2002
|
Regulatory Filing / Registration Change Control
|
X
|
(X)
|
4/2/2003
|
Regulatory Compliance
|
|
X
|
4/2/2004
|
Government Agency Inspections, Communications and Requisitions
|
(X)
|
X
|
4.3
Material Control
|
|||
4/3/2001
|
Test Methods and Specifications
|
X
|
|
4/3/2002
|
Material Destruction
|
(X)
|
X
|
4/3/2003
|
Vendor Audit Responsibility
|
X
|
X
|
4/3/2004
|
Material Certifications
|
X
|
X
|
4/3/2005
|
Incoming Material Release
|
|
X
|
4.4 Building, Facilities, Utilities and Equipment
|
|||
4/4/2001
|
General
|
|
X
|
4/4/2002
|
Equipment, Calibration and Preventative Maintenance
|
|
X
|
4/4/2003
|
Environmental Monitoring Program
|
|
X
|
4.5 Product Controls
|
|||
4/5/2001
|
Master Batch Record
|
(X)
|
X
|
4/5/2002
|
Reprocessing and Rework
|
N/A
|
N/A
|
4/5/2003
|
Personnel Training
|
|
X
|
4.7 Exception Reports (Deviations / Investigations)
|
|||
4/7/2001
|
Manufacturing Instruction Deviations
|
(X)
|
X
|
4/7/2002
|
Packaging Instructions Deviations
|
(X)
|
X
|
4/7/2003
|
Notification of Deviations
|
|
X
|
3.1
|
Any communications about the subject matter of this Agreement will be directed, in the first instance, to the person(s) identified in Appendix B.
|
3.2
|
Capitalized terms not otherwise defined herein will have the meaning specified in the MSA.
|
3.3
|
If any provision of this Agreement should be or found invalid, or unenforceable by law, the rest of the Agreement will remain valid and binding and the parties will negotiate a valid provision which meets as close as possible the objective of the invalid provision.
|
3.4
|
If this Agreement requires modification to comply with regulatory or legal requirements, such that either party affected cannot be reasonably expected to continue to perform under this Agreement, then the parties will negotiate and revise the Agreement accordingly
|
3.5
|
Any amendment of this Agreement will be made in writing and signed by both parties.
|
3.6
|
This Agreement will start on the Effective Date that is set forth on the cover page of this Agreement and will remain in force until the latest of: (i) the expiration date of the last batch of Product produced by Patheon for commercial distribution; (ii) completion of any ongoing stability studies; (iii) two years after the termination of the last effective MSA; or (iv) all Quality obligations under all applicable MSA’s have been fulfilled.
|
3.7
|
Despite the termination of this Quality Agreement all regulatory obligations contained herein that are required of either Party or both Parties by an applicable regulatory authority or agency shall survive termination of this Quality Agreement.
|
4.1
|
Quality Management
|
4.1.1
|
GMP, Health and Safety Compliance
|
4.1.2
|
MDCO Audit Rights
|
4.1.3
|
Subcontracting
|
4.1.4
|
Self-Inspection
|
4.2
|
Regulatory Requirements
|
4.2.1
|
Licenses, Marketing Authorizations and Permits
|
4.2.2
|
Regulatory Filing / Registration Change Control
|
4.2.3
|
Regulatory Compliance
|
4.2.4
|
Government Agency Inspections, Communication and Requisitions
|
4.3
|
Material Control
|
4.3.1
|
Test Methods and Specifications
|
4.3.2
|
Destruction of Active Pharmaceutical Ingredient or Product
|
4.3.3
|
Vendor Audit Responsibility
|
4.3.3.1
|
Excipient, Component and API Vendors:
|
(i.)
|
MDCO is responsible for the API vendor. MDCO will approve the API manufacturer/s and will inform Patheon about the approval status. MDCO will be also responsible for providing PATHEON with a proof of API manufacturer/s compliance with EU GMP Part II and will ensure the API cGMP compliance in accordance with Section 4.3.4 of this Agreement. The MDCO stipulated vendor(s) will be included on MDCO’s approved vendor list (attached hereto as Appendix D).
|
(ii.)
|
PATHEON is responsible for Components and excipient vendors. PATHEON will be responsible for approving the manufacturers and for ensuring their cGMP compliance in accordance with Patheon SOP. The PATHEON stipulated vendor(s) will be included on PATHEON’s approved vendor list (attached hereto as Appendix C).
|
4.3.4
|
Material Certifications
|
(i.)
|
That the materials are compliant with the provisions outlined in the “Note for Guidance on minimizing the risk of transmitting spongiform encephalopathy agents
|
(ii.)
|
A residual solvent certificate confirming that there is no potential for specific toxic solvents listed in the EP / USP / ICH residual solvents Class I, Class II or Class III to be present and the material, if tested, will comply with established EP / USP / ICH requirements. If any of the solvents listed in the EP / USP / ICH residual solvents Class I, Class II or Class III are used in the manufacture or are generated in the manufacturing process, solvents of concern will be indicated.
|
4.3.5
|
Incoming Material Release
|
4.4
|
Building, Facilities, Utilities and Equipment
|
4.4.1
|
General
|
4.4.2
|
Equipment, Calibration and Preventative Maintenance
|
4.4.3
|
Environmental Monitoring Program
|
4.5
|
Production Controls
|
4.5.1
|
Master Batch Record
|
4.5.2
|
Reprocessing and Rework
|
4.5.3
|
Personnel Training
|
4.6
|
Exception Reports (Deviations / Investigations)
|
4.6.1
|
Manufacturing Instruction Deviations
|
4.6.2
|
Primary Packaging Instructions Deviations
|
4.1
|
Release of Product
|
4.1.5
|
Test Methods and Specifications
|
4.1.6
|
Batch Release for Shipment
|
4.1.7
|
Certificate of Analysis & Certificate of Compliance
|
4.1.8
|
Product Release to Market
|
4.2
|
Validation
|
4.2.5
|
Master Validation Plan
|
4.2.6
|
Cleaning & Cleaning Validation Programs
|
4.2.7
|
4.9.3 Analytical Method and Procedure Validation
|
4.3
|
CHANGE CONTROL
|
4.3.6
|
General
|
4.4
|
Documentation
|
4.4.4
|
Record Retention
|
4.5
|
Laboratory Controls
|
4.5.4
|
Specifications and Test Methods
|
4.5.5
|
Out of Specifications (OOS)
|
4.5.6
|
Supply of Reference Standards
|
4.6
|
Stability
|
4.6.3
|
Sample Storage
|
4.6.4
|
Stability Studies and Protocol
|
4.6.5
|
Stability Failures
|
4.6.6
|
Termination of MSA
|
4.7
|
Annual Product Review
&
Product Quality Review
|
4.8
|
Storage and Distribution
|
4.8.1
|
General
|
4.8.2
|
Product Storage and Shipment Changes
|
4.8.3
|
Product Quarantine
|
4.8.4
|
Shipment and Distribution
|
4.9
|
Product Complaints
|
4.9.1
|
Complaint Investigation
|
4.10
|
Product Recall
|
4.10.1
|
Product Recall Notification
|
4.10.2
|
Government Agency Notification
|
4.11
|
Reference and retention Samples
|
4.11.1
|
Excipient, Active Pharmaceutical Ingredient, and Product Reference Samples
|
4.11.2
|
Active Pharmaceutical Ingredient and Product Retention Sample
|
•
|
Appendix A: Product(s)
|
•
|
Appendix B: Quality Contacts
|
•
|
Appendix C: Patheon Approved Supplier List
|
•
|
Appendix D: MDCO Approved Supplier List
|
•
|
Appendix E: Patheon Approved Contract Laboratories List
|
Products (s)
|
Galenic Form
|
Dosage (Strength)
|
Bivalirudin (Angiomax & Angiox
|
lyophilized
|
250mg/mL
|
|
Patheon
|
MDCO
|
Responsibility
|
Quality Assurance
|
Quality Assurance
|
Name
|
Maria Di Cillo
|
Batsheva Bain
|
Title
|
QA/QC Manager-QP
|
Director, Supplier Quality and Regulatory Compliance
|
Phone
|
390,292,047,509
|
973-290-6326
|
Fax
|
390,292,047,314
|
862-207-6326
|
E-mail
|
maria.dicillo(3)pa theon.com
|
Batsheva.bain@themedco.com
|
Address
|
Viale G.B. Stucchi, 110 20900 Monza (MB)
|
The Medicines Company
8 Sylvan Way Parsippany, NJ 07054 |
Responsibility
|
Regulatory Affairs
|
Regulatory Affairs
|
Name
|
Isabella Scrocchi
|
Batsheva Bain
|
Title
|
Regulatory Affairs Manager
|
Director, Supplier Quality and Regulatory Compliance
|
Phone
|
390,292,047,270
|
973-290-6326
|
Fax
|
390,292,047,314
|
862-207-6326
|
E-mail
|
isabella.scrocchi@patheon.com
|
Batsheva.bain@themedco.com
|
Address
|
Viale G.B. Stucchi, 110 20900 Monza (MB)
|
The Medicines Company
8 Sylvan Way Parsippany, NJ 07054 |
Responsibility
|
Product Complaints
|
Product Complaints
|
Name
|
Francesco Boschi
|
Jamal Brown
|
Title
|
Complaints & Self audits
|
Director, Quality
|
Phone
|
390,292,047,271
|
973-290-6145
|
Fax
|
390,292,047,314
|
862-207-6145
|
E-mail
|
francesco.boschi@patheon.
|
Jamal.brown@themedco.com
|
com
|
|
|
Address
|
Viale G.B. Stucchi, 110 20900 Monza (MB)
|
The Medicines Company
8 Sylvan Way Parsippany, NJ 07054 |
Responsibility
|
Product Release
|
Product Release
|
Name
|
Maria Di Cillo
|
Batsheva Bain
|
Title
|
QA/QC Manager-QP
|
Director, Supplier Quality and
Regulatory Compliance |
Phone
|
390,292,047,509
|
973-290-6326
|
Fax
|
390,292,047,314
|
862-207-6326
|
E-mail
|
maria.dicillo@patheon.com
|
Batsheva.bain@themedco.com
|
Address
|
Viale G.B. Stucchi, 110
20900 Monza (MB) |
The Medicines Company
8 Sylvan Way Parsippany, NJ 07054 |
Responsibility
|
Account Manager
|
Business Manager
|
Name
|
Andrea Como
|
Angie Green
|
Title
|
Technical Business
Manager |
Vice President, Manufacturing
Outsourcing Operations |
Phone
|
0039.039.2047.433
|
973-290-6042
|
Fax
|
|
862-207-6042
|
E-mail
|
andrea.como@patheon.com
|
Angie.green@themedco.com
|
Address
|
Viale G.B. Stucchi, 110
20900 Monza (MB) |
The Medicines Company
8 Sylvan Way Parsippany, NJ 07054 |
Argentina
|
Israel
|
Australia
|
New Zealand
|
Brazil
|
Peru
|
Canada
|
Russia
|
Chile
|
Switzerland
|
China
|
Turkey
|
India
|
Venezuela
|
THE MEDICINES COMPANY,
Plaintiff,
v.
TEVA PARENTERAL MEDICINES, INC.,
TEVA PHARMACEUTICALS USA, INC. and TEVA PHARMACEUTICAL INDUSTRIES, LTD.
Defendants.
|
)
)
)
)
) C.A. No. 09-750 (ECR)
) (Consolidated)
)
)
)
)
)
)
|
THE MEDICINES COMPANY,
Plaintiff,
v.
PLIVA HRVATSKA d.o.o.,
PLIVA d.d.,
BARR LABORATORIES, INC.,
BARR PHARMACEUTICALS, INC.,
BARR PHARMACEUTICALS, LLC,
TEVA PHARMACEUTICALS USA, INC. and TEVA PHARMACEUTICAL INDUSTRIES, LTD.
Defendants.
|
)
)
)
)
) C.A. No. 09-751 (ECR)
) (Consolidated)
)
)
)
)
)
)
)
)
)
)
|
THE MEDICINES COMPANY,
Plaintiff,
v.
TEVA PARENTERAL MEDICINES, INC.,
TEVA PHARMACEUTICALS USA, INC. and TEVA PHARMACEUTICAL INDUSTRIES, LTD
Defendants.
|
)
)
)
)
) C.A. No. 09-999 (ECR)
) (Consolidated)
)
)
)
)
)
|
THE MEDICINES COMPANY,
Plaintiff,
v.
PLIVA HRVATSKA d.o.o.,
PLIVA d.d.,
BARR LABORATORIES, INC.,
BARR PHARMACEUTICALS, INC.,
BARR PHARMACEUTICALS, LLC,
TEVA PHARMACEUTICALS USA, INC. and TEVA PHARMACEUTICAL INDUSTRIES, LTD.
Defendants.
|
)
)
)
)
) C.A. No. 09-1000 (ECR)
) (Consolidated)
)
)
)
)
)
)
)
)
)
)
|
(i)
|
if sent by hand, be deemed to have been given when delivered at the relevant address;
|
(ii)
|
if sent by prepaid mail, be deemed to have been given five (5) days after posting; or
|
(iii)
|
if sent by confirmed fax transmission be deemed to have been given when transmitted, provided that, a confirmatory copy of such fax transmission shall have been sent by prepaid overnight mail within twenty-four (24) hours of such transmission.
|
To MDCO
The Medicines Company
8 Sylvan Way
Parsippany, NJ 07054
Attn: Chief Executive Officer
Facsimile:
with a copy to:
The Medicines Company
8 Sylvan Way
Parsippany, NJ 07054
Attn: General Counsel
Facsimile:
|
To Teva
Teva Pharmaceuticals USA, Inc.
1090 Horsham Road PO Box 1090 North Wales, PA 19454-1090 Attn: Chief Executive Officer Facsimile: 215-591-8803
with a copy to:
Teva North America
425 Privet Road Horsham, PA 19044 Attention: General Counsel Facsimile: 215-293-6499 |
1.1.
|
The preamble to this Agreement forms an integral part hereof.
|
1.2.
|
Clause headings in this Agreement are intended solely for convenience of reference and shall be given no effect in the interpretation of this Agreement.
|
1.3.
|
All appendices to this Agreement, if any, whether attached at the time of signature hereof or at any time thereafter, shall be construed as an integral part of this Agreement. In case of any inconsistency between the appendices and the body of the Agreement, the body of the Agreement shall take precedence and prevail over the appendices to the extent of any such inconsistency.
|
1.4.
|
In this Agreement, the following expressions shall bear the meanings assigned to them below and cognate expressions shall bear corresponding meanings.
|
1.4.1.
|
“
Affiliates
”– with regard to either Party, any person, corporation, company, partnership, joint venture or other entity controlling, controlled by or under common control with such Party. For such purpose the term “control” means the holding of fifty percent (50%) or more of the common voting stock or ordinary shares in, or the right to appoint fifty percent (50%) or more of the directors of, or the right to share fifty percent (50%) or more of the profits of, the said corporation, company, partnership, joint venture or entity. For the purposes of this Agreement, Teva Pharmaceutical Industries Limited and any Affiliates of Teva Pharmaceutical Industries Limited, including, Teva Parenteral Medicines, Inc., Teva Pharmaceuticals USA, Inc., Pliva Hrvatska d.o.o., Pliva d.d., Barr Laboratories, Inc., Barr Pharmaceuticals, Inc., Barr Pharmaceuticals, LLC, and Plantex Ltd. shall be deemed Affiliates of Plantex. Wherever one or more Affiliates of Plantex are involved in or responsible for any of the activities and obligations ascribed to Plantex in this Agreement, the omission of specific reference to any such Affiliates in any such instances shall not relieve Plantex or such Affiliates from responsibility for such activities and obligations.
|
1.4.2.
|
“
Alternative Material
”–active pharmaceutical ingredient equivalent to the API, as defined below, which is manufactured by a third party holding a drug master file for such active material.
|
1.4.3.
|
“
APl
”–the active pharmaceutical ingredient bivalirudin.
|
1.4.4.
|
“
Authorized Generic
”– a generically labeled lyophilized bivalirudin drug product marketed by Purchaser or a third party authorized by Purchaser.
|
1.4.5.
|
“
DMF
”– the drug master file filed and maintained by Plantex and its Affiliates with the FDA relating to the manufacture of the API.
|
1.4.6.
|
“
Effective Date
”‑ the date at the head of this Agreement, provided that the Agreement has been duly executed by both Parties.
|
1.4.7.
|
“
FDA
”–the United States Food and Drug Administration and all agencies under its direct control or any successor organization.
|
1.4.8.
|
“
Finished Product
” - the finished form of pharmaceutical product to be formulated by Purchaser, using the API as the active ingredient.
|
1.4.9.
|
"
cGMP
" – current good manufacturing practices in accordance with the rules and regulations promulgated by the FDA.
|
1.4.10.
|
“
Marketing Authorizations
”– the required authorizations and approvals to be granted by the FDA or any other duly designated Regulatory Authority in the Territory for the marketing, use and sale or distribution of the Finished Product in the Territory.
|
1.4.11.
|
“
Party
”–Plantex or Purchaser as the context requires, and “Parties” collectively PLANTEX and Purchaser.
|
1.4.12.
|
“
Plantex’s Facility
” - a manufacturing facility identified in the DMF for purposes of manufacture of the API pursuant to this Agreement.
|
1.4.13.
|
“
Quarter
”– a three-month consecutive period with the first three month period commencing on the first of either January 1, April 1, July 1 or October 1 and each subsequent 3 month calendar period commencing on the day immediately following the last day of the then immediately preceding period.
|
1.4.14.
|
“
Quality Agreement
”– the API Quality Agreement between Purchaser and Plantex Ltd., of even date herewith, relating to the manufacture of the API.
|
1.4.15.
|
“
Regulatory Authorities
” - any and all governmental bodies and organizations, including, without limitation, the FDA, which regulate the manufacture, importation, distribution, use or sale of the API or Finished Product in the Territory.
|
1.4.16.
|
“
Specifications
”–the technical specifications of the API set out in
Appendix A
.
|
1.4.17.
|
“
Territory
”–the United States of America, and each of its territories, districts and possessions and the commonwealth of Puerto Rico, subject to Section 2.3.
|
1.4.18.
|
“
Term
”– as defined in Section 9.
|
2.1.
|
During the Term, Plantex hereby agrees to manufacture, sell and supply to Purchaser solely for the formulation by or for Purchaser of the Finished Product and the licensing, marketing and sale thereof solely in the Territory, and Purchaser hereby agrees to purchase the API produced by Plantex on the terms and conditions set out in this Agreement for the said sole purpose.
|
2.2.
|
In the event that Purchaser desires to transfer the Marketing Authorizations to one or more third parties, Plantex shall provide such third parties with a “Letter of Access” to the DMF; provided that Plantex’ agreement to do so may be conditioned upon the agreement of the Purchaser to assign this Agreement to such third party.
|
2.3.
|
In the event that Purchaser requests to expand the Territory covered in this Supply Agreement, Plantex will use commercially reasonable efforts to support such request.
|
3.1.
|
Commercial Supply
.
|
3.1.1
|
Purchaser shall issue Purchase Orders for a minimum of [**] kgs in [**], a minimum of [**] kgs in [**], and a minimum of [**] kgs in [**] of the API from Plantex. These requirements shall remain fixed regardless of whether or not a generic form of Angiomax is launched in the market in the Territory.
|
3.1.2
|
Beginning in [**] and for the duration of the Term thereafter, Purchaser shall issue Purchase Orders for a minimum [**] kgs of the API per calendar year from Plantex, subject to Section 3.1.2.1 below.
|
3.1.2.1
|
If a generic form of Angiomax is launched in the market in the Territory, then from and after January 1, 2013 Purchaser shall have the right to terminate its agreement to purchase API hereunder with immediate effect, and the Parties will meet in good faith to discuss terms for Purchaser’s possible continued purchase of API (as to both quantities and, as provided in Section 4.3, the price of the API).
|
3.2.
|
Purchaser and its Affiliates shall use the API only for the manufacture of Finished Products for sale or use in the Territory. Purchaser and its Affiliates are prohibited from reselling or otherwise transferring all or any portion of API that is not used in the manufacture of Finished Products for sale or use in the Territory to any other person or entity, either directly or indirectly, including through its contract manufacturers or other third parties, without written permission of Plantex.
|
3.3.
|
Forecasts
. On or before October 31, 2011
, and thereafter by the 15th day of each October and April during the Term, Purchaser shall provide Plantex with a good faith, twenty-four (24) month rolling forecast of its API requirements by quarter (“Forecast”) commencing from the quarter following the quarter in which the Forecast is provided (i.e. January or July, as the case may be)
..
The first [**] months of each Forecast, shall be considered binding
(the "Binding Forecasted Period")
for the API indicated for those months
. The quantities set forth in each Binding Forecasted Period for each Forecast shall not be in an amount less than eighty percent (80%) or greater than one hundred and twenty percent (120%) of the quantities set forth in the second [**] month period of the immediately preceding Forecast.
|
3.4.
|
Orders
. Concurrent with Purchaser supplying Plantex with the Forecasts, the Purchaser shall place firm purchase orders for the quantities not less than the quantities specified in the Binding Forecasted Period of such Forecasts ("
Purchase Orders
"). Purchase Orders shall reference this Agreement and specify the API, quantities, prices, delivery destination and required delivery dates, which shall be in accordance with the applicable Forecast. In the event Purchaser provides Purchase Orders subsequent to the date of submitting the Forecast, the required delivery dates in such Purchase Orders shall be at least ninety (90) days from the date of placing the Purchase Order, except as otherwise specifically and expressly agreed to in writing by Plantex ("
Lead Time
"). Purchase orders shall be subject to confirmation and acceptance by Plantex, at its sole discretion. Purchaser has placed a Purchase Order applicable to its 2011 requirements, a copy of which is attached as Appendix B.
|
3.5.
|
Plantex shall use its commercially reasonable efforts to confirm and accept Purchase Orders and supply the quantities set forth in the Purchase Orders within [**] business days of the designated delivery dates (provided that such Purchase Orders comply with the applicable Lead Time). Plantex shall promptly advise Purchaser if, for any reason, including without limitation force majeure as defined in Section 13 hereof, it believes that it will be unable to supply Purchaser (a) with the requisite quantities of API specified in a Purchase Order, or (b) by the date of delivery specified in a Purchase Order.
|
3.6.
|
Delivery
. The API shall be delivered EX WORKS (per Incoterms 2010) at Plantex’ Facility.
|
3.7.
|
Risk of Loss and Title
. Risk of loss and/or damage to the API ordered by Purchaser, and title therein, will pass to Purchaser upon delivery of the API.
|
3.8.
|
Quality
. At the time of the delivery, the API shall conform to the Specifications. Certain of the Parties’ responsibilities with respect to the API are set forth in the Quality Agreement, which is incorporated herein as if set forth at length.
|
3.9.
|
Packaging
. The API shall be delivered to Purchaser as specified in the DMF and Specifications.
|
4.1.
|
The price for the minimum purchase quantities of API provided in Section 3.1 will be fixed at $[**] per gram for [**] and [**] and $[**] per gram for [**].
|
4.2.
|
Beginning with [**] and for the duration of the Term thereafter, so long as Purchaser purchases [**] kgs or more per year of the API, the price shall be $[**] per gram, but if Purchaser purchases less than [**]kgs per year of the API, the price shall be $[**] per gram.
|
4.3.
|
Notwithstanding the above, pricing for [**] and for the duration of the Term shall be subject to Section 3.1.2.1 and Sections 4.3.1 and 4.3.2 below:
|
4.3.1.
|
If a generic form of Angiomax is launched in the market in the Territory, the Parties will meet to discuss, in accordance with Section 3.1.2.1, Purchaser’s possible continued purchase of API and the pricing for [**] and for the duration of the Term.
|
4.3.2.
|
Plantex shall be entitled to modify the price of the API beginning with calendar year [**] and for each calendar year in the Term thereafter due to a documented increase of more than [**]% of the manufacturing cost of the API which is a result of increases of the purchase price index, cost of goods, labor and overhead charges and any changes in the market which have affected the price; provided that in no event will Plantex be able to increase the price for the API more than [**]% in any calendar year.
|
4.4.
|
Plantex shall issue and dispatch invoices with each delivery (or partial delivery) of the API delivered by it together with such certificates and documentation as may be required for the purposes of customs clearance of the API including without limitation a signed certificate of analysis.
|
4.5.
|
All invoices shall be paid in US Dollars within [**] days from the date of the applicable invoice. Prices do not include any sales tax, which shall be payable by Purchaser if applicable. Payments shall be made by wire transfer to Plantex’s designated bank account as notified to Purchaser by Plantex.
Amounts not paid when due shall accrue interest calculated at the rate of four percent (4%) plus the U.S. prime rate (but in no event greater than the maximum rate permitted by law) in effect on the date that the payment should have been made, as published in The Wall Street Journal, Eastern U.S. Edition, calculated on a daily basis. No deductions of any kind from any payment becoming due to Plantex may be made in the absence of an official credit memorandum from Plantex authorizing the deduction.
|
5.1.
|
Purchaser shall inspect each shipment upon its receipt of API for all defects and conformance with the Specifications. Any API not rejected within [**] days of delivery to Purchaser shall be deemed to have been accepted by Purchaser. Any latent defects in API not detectable by means of the inspection specified in this Section shall be notified by Purchaser to Plantex promptly after discovery thereof but by not later than the date of expiration of the shelf life for the relevant API.
|
5.2.
|
In the event that Purchaser alleges that any API delivered to it does not meet the Specifications, Purchaser shall notify Plantex setting out full details of the alleged defect. Purchaser shall, on request by Plantex, provide Plantex with a sample of the allegedly non-conforming API, which shall be examined by Plantex as soon as reasonably practicable but in any event within [**] days of receipt thereof by Plantex.
|
5.3.
|
In the event that Plantex is in agreement with the contentions as to non-conformance raised by Purchaser:
|
5.3.1.
|
Plantex shall at its sole discretion either: (1) credit Purchaser the amount paid or invoiced for such API or (2) dispatch to Purchaser replacement API as soon as is reasonably practicable but in any event within [**] days following Purchaser's notification of non-conformance, all costs in respect of which shall be borne by Plantex;
|
5.3.2.
|
Purchaser shall, if so requested by Plantex, return to Plantex at Plantex’s expense, any API that is nonconforming or otherwise dispose of such API, at Plantex’s expense, and in accordance with instructions provided by Plantex. If Plantex does not so direct, within [**] business days following Purchaser's notification of non-conformity, Purchaser may dispose of such API as Purchaser may deem reasonably appropriate, provided that any such disposal complies with environmentally acceptable standards, and Plantex shall bear the costs of such disposal.
|
5.3.3.
|
Plantex’s liability in any such case remains strictly limited only to replacement of or credit for the API.
|
5.4.
|
In the event that Plantex is not in agreement with the contentions as to non-conformance raised by Purchaser, representative samples of the allegedly non-conforming API, together with details of Purchaser’s contentions as to non-conformance, shall be submitted to a mutually acceptable independent laboratory which shall examine such samples in a method specified by the Parties as part of a mutually agreed testing procedure. The Parties shall endeavor to procure that within thirty (30) days, the said laboratory issues its finding as to whether the API conforms to the specifications. The results of the said laboratory shall be final and binding on the Parties, and not subject to appeal or review, and the costs associated with such submission and determination shall be borne by the Party against which the laboratory decides. Notwithstanding the above, if it is determined that the non-
|
5.5.
|
Plantex shall, upon receiving a written request from Purchaser, supply technical information on the API and methods of manufacture to the extent that such information is necessary to enable Purchaser to fulfill its obligations under this Agreement, including compliance with any statutory or Regulatory Authority located within the Territory. Upon Plantex receiving at least [**] days advance notice in writing from Purchaser, and not more than once every two (2) years, Plantex shall permit Purchaser, by prior arrangement with and at a time convenient to Plantex, to inspect those areas of Plantex’s Facilities where API is manufactured for Purchaser, and audit its records (in the presence of a representative of Plantex) relating to the manufacturing and quality control of the API to the extent reasonably necessary to enable Purchaser to verify compliance with any regulatory requirements to which Purchaser is subject and which are applicable to the manufacture, importation, and marketing of the API. Purchaser acknowledges that all information supplied by Plantex or acquired by Purchaser by virtue of the provisions of this clause shall be strictly confidential and subject to the provisions of Section11 hereof.
|
5.6.
|
Purchaser undertakes to be solely responsible for any recall of the Finished Products at any time, and to accept any liability arising in respect of the Finished Products.
|
5.7.
|
In the event of a conflict between the terms set forth in this Section 5 and the terms provided in the Quality Agreement, the terms set forth in the Quality Agreement shall control.
|
6.1.
|
PLANTEX, on behalf of itself and its Affiliates, hereby represents, warrants and covenants to the Purchaser that:
|
6.1.1.
|
the API shall conform to the Specifications;
|
6.1.2.
|
the API to be supplied hereunder shall be manufactured, stored and packaged for shipment in accordance with cGMP at a Plantex Facility;
|
6.1.3.
|
all API supplied hereunder shall be free and clear of all security interests, liens, or other encumbrances of any kind or character; and
|
6.1.4.
|
all API supplied hereunder shall be accompanied by all documentation necessary for the use in the Territory under the applicable Marketing Authorizations.
|
6.2.
|
Expect as set forth in Section 3.5 and as may be subject to indemnification under Section 8.2, the replacement of non conforming API shall be
|
6.3.
|
THE WARRANTIES SET OUT ABOVE ARE THE ONLY WARRANTIES GIVEN BY PLANTEX AND ARE MADE IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED. ANY EXPRESS OR IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE OR MERCHANTABILITY APPLICABLE TO THE APIARE HEREBY EXCLUDED.
|
6.4.
|
Plantex hereby represents and warrants that it has the authority to bind all of its Affiliates to the terms of this Agreement.
|
6.5.
|
Plantex makes no warranty as to the patentability of any of the API or as to immunity from any action for infringement of third party intellectual property rights including but not limited to registered patents or patent applications arising out of the regulatory approvals, importation into the territory, distribution, marketing, sale and/or use of the API.
|
6.6.
|
If any limitation of liability shall be deemed invalid by any applicable law, then each Party’s liability shall be within the limitation permitted by that law.
|
7.1.
|
In the event a claim for patent infringement is brought against Purchaser on account of Plantex’s supply of API to Purchaser and use thereof in the manufacture, use, marketing or sale of the Finished Product, or Purchaser has reason to believe that any such claim might be brought against it, Purchaser shall inform Plantex as soon as possible of the particulars of the claim. Plantex shall cooperate with Purchaser in the defense of any such claim.
|
7.2.
|
The provisions of this Section 7 shall survive the expiration or termination of this Agreement for any reason.
|
8.1.
|
Subject to and without derogating from the limitations of Purchaser’s liabilities as set forth in this Agreement, the Purchaser shall defend, indemnify and hold Plantex, its Affiliates and each of their respective officers, directors, agents, employees and shareholders (collectively, “
Plantex Indemnitees
”) harmless from and against any and all claims, damages, loss and expense suffered by Plantex arising from claims by third parties in connection with or resulting from any of the following: (a) the storage, handling, manufacture, license, use, marketing, advertising, promotion, distribution or sale of the Finished Product by Purchaser or its Affiliates, sublicensees, distributors or agents or the conduct of business by Purchaser or its Affiliates, sublicensees, distributors or agents in the Territory, including, but not limited to, liabilities for product liability and returned goods; and (b) the breach of any representation, warranty or covenant by Purchaser under this Agreement; and (c) gross negligence or willful misconduct by the Purchaser or its Affiliates and each of their respective officers, directors, agents, employees in connection with the implementation of this Agreement; and (d) violation of any applicable law by Purchaser or any of its Affiliates and each of their respective officers, directors, agents, employees; and (e) any bodily injury, illness or death of any person caused or alleged to be caused by the use, distribution or sale of the Finished Product; and (f) any actual or alleged infringement (whether direct, contributory, or induced) or violation of any patent, trade secret or proprietary rights of any third party arising out of Purchaser’s or its Affiliates and each of their respective officers, directors, agents and employees manufacturing, importing, registering, storing, distributing or selling the Finished Product.
|
8.2.
|
Subject to and without derogating from the limitations of Plantex' liabilities as set forth in this Agreement, Plantex shall defend, indemnify and hold the Purchaser, its Affiliates and each of their respective officers, directors, agents, employees and shareholders (collectively, “
Purchaser Indemnitees
”) harmless from and against any and all damages, loss or expense suffered by Purchaser arising from claims by third parties in connection with or resulting from any of the following: (a) the breach of any representation, warranty or covenant by Plantex under this Agreement; and (b) gross negligence or willful misconduct by Plantex or its Affiliates and each of their respective officers, directors, agents, employees in connection with the implementation of this Agreement; and (c) violation of any applicable law by Plantex or any of its Affiliates and each of their respective officers, directors, agents, employees. Not withstanding the above section 8.2 Plantex’s liability in the event of a product liability claim shall be limited to the aggregate dollar value of the Purchaser’s minimum purchase requirements, as set forth in this agreement, actually ordered by Purchaser for the twelve months immediately proceeding the time the claim is made.
|
8.3.
|
Each of Purchaser and Plantex (“
the Indemnitee
”) undertakes in favor of the other of them (“
the Indemnifier
”):
|
8.3.1.
|
to promptly notify the Indemnifier of the bringing or threat of any claim or legal proceeding against the Indemnitee and for which the Indemnitee is indemnified by the Indemnifier;
|
8.3.2.
|
to abide by such lawful and reasonable instructions as the Indemnifier may issue concerning the conduct of such claim, or the defense of such proceeding and at the Indemnifiers request to relinquish control of such claim or defense to the Indemnifier.
|
8.3.3.
|
not to make, without the Indemnifier’s express written authorization, any admission of liability to a claimant or plaintiff or his or her legal representative or insurer in respect of such claim or such proceedings or threatened proceedings and,
|
8.3.4.
|
not to make, without the Indemnifier’s express written authorization, any settlement or compromise of such claim or threatened claim or such proceedings or threatened proceedings.
|
8.4.
|
Neither party shall be liable to the other party (whether under contract or tort, including negligence) or otherwise, or to any third party for any indirect, special or consequential damages, including without limitation, for any loss or damage to business earnings, anticipated sales, anticipated or lost profits or goodwill suffered by the other party and/or related with and/or connected to the performance of this Agreement, even if such party is advised or should have known of the possibility of such damages.
|
8.5.
|
The provisions of this Section 8 shall survive the expiration or termination of this Agreement for any reason.
|
10.
|
BREACH AND TERMINATION
|
10.1.
|
Either of Plantex or Purchaser may terminate this Agreement prior to its expiration at any time by sending a written notification to the other Party in the event that:
|
10.1.1.
|
the other Party fails materially to perform any obligation hereunder or the other Party materially violates any representation or warranty made herein and such failure or violation continues unremedied for a period of thirty (30) days following written notice by the terminating Party; or
|
10.1.2.
|
the other party admits to being or is declared insolvent or voluntary or involuntary proceedings are instituted by or against it in bankruptcy, or receivership, or for a winding-up or for the dissolution or re-organization of its assets.
|
10.2.
|
Purchaser shall have the right to terminate this Agreement with immediate effect upon the breach of the Settlement Agreement or section 3.3 or 3.10.2 of the License Agreement by an Affiliate of Plantex and as otherwise set forth in the Settlement Agreement. In the event this Agreement is terminated pursuant to this Section 10.2, all of Purchaser’s obligations herein, including the minimum purchase requirements set forth in Section 3.1 and any requirement to order or purchase API (including any outstanding orders or already manufactured API) shall immediately terminate.
|
10.3.
|
Purchaser shall have the right to terminate this Agreement
|
10.4.
|
Except with respect to a termination pursuant to Section 10.2, or unless agreed otherwise between the Parties, Purchaser will be required to purchase, and Plantex shall be required to supply the API in respect of which orders have been placed prior to expiration or termination of the Agreement, but not yet supplied on the date of termination.
|
10.5.
|
Upon termination of this Agreement, all rights and obligations will cease to exist except for (a) the payment of unpaid invoices due, (b) the confidentiality and Indemnification rights and obligations of the Parties, which shall survive the termination of this Agreement for a period of ten (10) years, and (c) any other term or condition that by its term survives termination. Clauses referring to governing law and jurisdiction shall survive the termination of this Agreement.
|
11.1.
|
In carrying out the terms of this Agreement and/or the Quality Agreement it may be necessary, from time to time, for a Party to disclose to the other Party certain information which is considered by the disclosing Party to be proprietary and of confidential nature (the “
Confidential Information
”). Confidential Information shall include but shall not be limited to, any and all information, know-how and data, technical or non-technical, concerning any finished drug product or active pharmaceutical ingredient, its Manufacture, marketing and sale, plans, processes, compositions, formulations, specifications, samples, systems, techniques, analyses, production and quality control data, testing data, marketing and financial data, and such other information or data relating to any finished drug product or active pharmaceutical ingredient.
|
11.2.
|
The recipient of any Confidential Information shall not use it for any purpose other than for the purposes of fulfilling its obligations under this Agreement. The recipient shall disclose Confidential Information only to those of its officers, directors, employees advisors and Affiliates (and such Affiliates' officers, directors, employees and advisors) requiring knowledge thereof in connection with their duties directly related to the implementation of this Agreement, and said officers, directors, employees, advisors and Affiliates (and such Affiliates' officers, directors, employees and advisors) shall hold the information in confidence pursuant to this Agreement. The recipient agrees that it will exercise the same degree of care and protection to preserve the proprietary and confidential nature of the Confidential Information disclosed by the disclosing Party, as recipient would exercise to preserve its own proprietary and confidential information, and in any case no less than a reasonable degree of care. Recipient agrees that it will, upon request of the disclosing party, immediately return all documents and any copies thereof containing Confidential Information belonging to, or disclosed by the disclosing party.
|
11.3.
|
Confidential Information shall not be deemed to include:
|
11.3.1.
|
Information in the public domain or which was known to or in the
|
11.3.2.
|
Information which is independently developed by recipient or its Affiliates and which can be evidenced by way of documentation.
|
11.3.3.
|
Information that becomes available to recipient on a non-confidential basis, whether directly or indirectly, from a source other than a Party, which source, to the best of recipient’s knowledge, did not acquire this information on a confidential basis.
|
11.3.4.
|
Information which recipient is required to disclose pursuant to a valid order of a court or other governmental body or otherwise required by law upon prior notice to the other Party that such Confidential Information has been required.
|
11.4.
|
Upon expiration or earlier termination of this Agreement, the recipient of any Confidential Information shall, as the disclosing Party may direct in writing, either destroy or return to the disclosing Party all Confidential Information disclosed together with all copies thereof, provided, however, the recipient may retain one archival copy thereof for the purpose of determining any continuing obligations of confidentiality.
|
11.5.
|
The provisions relating to confidentiality in this Section shall remain in effect following termination of this Agreement for a period of ten (10) years.
|
11.6.
|
All publicity, press releases and other announcements relating to this Agreement or the transactions contemplated hereby shall be reviewed in advance by, and shall be subject to the approval of, both Parties. Each Party responding to a request for such approval shall respond to the requesting Party in writing within five (5) days of such request or within such shorter period as either Party may require in order to comply with applicable law.
|
13.1.
|
Except for the obligation of a Party to make payments to the other pursuant to this Agreement (that will not be deferred or extended for any reason), neither Party shall be liable for any non-performance or delay in
|
13.2.
|
In the event of either Party being so hindered or prevented, such Party shall give notice of suspension as soon as reasonably possible to the other Party stating the date and extent of such suspension and the cause thereof.
|
13.3.
|
Any Party whose obligations have been suspended as aforesaid shall nevertheless make every endeavor to carry out its obligations under this Agreement, even if in a partial or compromised manner, and shall resume the performance of such obligations as soon as commercially reasonable after the removal of the cause and shall so notify the other Party.
|
13.4.
|
In the event that such cause continues for more than six (6) consecutive months either Party may terminate this Agreement on fourteen (14) days written notice to the other Party, and in such event neither Party shall have any claim against the other arising from such termination.
|
14.1.
|
Non-assignability
: This Agreement may not be assigned in whole or in part by either of the parties hereto without the prior written consent of the non assigning party hereto.
Such consent may be conditioned upon the agreement of the assigning Party to remain primarily liable for performance of all obligations of the assignee.
Both Parties shall be entitled to assign, delegate, and/or subcontract its rights and obligation under this Agreement, in whole or in part, to one or more of its Affiliates on prior written notice to the other Party. Purchaser shall be entitled to assign, delegate, and/or subcontract its rights and obligation under this Agreement, in whole, to a third party that acquires ownership of the NDA. The foregoing notwithstanding, either Party shall be entitled to assign this Agreement to an acquirer of all or substantially all of its capital stock or assets, whether through purchase, merger, consolidation or otherwise.
|
14.2.
|
Power and representation
: Each Party has full power and authority to execute, deliver and perform this Agreement and to incur the obligations provided herein under their respective laws. The entering into of this Agreement has been duly authorized by all proper and necessary action, corporate or otherwise, of each of the Parties. No consent or approval of shareholders or of any other person, other than those which have been obtained by each Party and remain in effect, is required as a condition to the validity, implementation or enforceability of this Agreement.
|
14.3.
|
No intellectual property rights
: Nothing in this Agreement shall be deemed to give either Party any right, title, license or other interest in or to any trade name, trade mark, patent, copyright, design, packaging, set-up or other intellectual property right of the other of them or any of its Affiliates retaining
|
14.4.
|
UN Convention
: To the extent that it may otherwise be applicable, the Parties hereby expressly agree to exclude from the operation of this Agreement, the United Nations Convention on Contracts for the International Sale of Goods, concluded at Vienna, on 11 April 1980, as amended and as may be amended further from time to time.
|
14.5.
|
Entire Agreement
: This Agreement constitutes the entire understanding between the Parties with regard to the subject matter hereof, and supersedes all prior written and oral understandings and agreements. This Agreement may be amended only by a written instrument duly signed by the Parties.
|
14.6.
|
Insurance
:
|
14.7.
|
Conflict with other documents
: In the event of any conflict between the terms and conditions of this Agreement and the terms and conditions set forth in any standard or other purchase order documentation or any document evidencing acceptance thereof or setting out terms of delivery and/or payment, the terms and conditions of this Agreement shall prevail unless such other document records expressly state that it prevails over this Agreement and is signed by duly authorized representatives of both Parties.
|
14.8.
|
No Agency
: Plantex and Purchaser will act at all times as independent
|
14.9.
|
Either Parties’ failure to terminate or seek redress for a breach of, or to insist upon strict performance of any term, covenant, condition or provision contained in this Agreement will not prevent a similar subsequent act from constituting a breach of this Agreement.
|
14.10.
|
If any portion of this Agreement is determined to be illegal or otherwise unenforceable by agreement of the Parties, by an arbitrator, by a court of competent jurisdiction or by an administrative agency of competent jurisdiction, that Section, to the extent permitted by law, shall be treated as deleted from this Agreement and the remaining portions of this Agreement will continue to be in full force and effect according to the terms hereof.
|
14.11.
|
This Agreement may be executed in one or more counterparts, each of which shall constitute an original and all of which, when taken together, shall constitute one agreement.
|
14.12.
|
It is hereby acknowledged that the manufacturer of the API(provided such manufacturer is an Affiliate of Plantex) is intended to be a third party beneficiary hereunder such that all representations and covenants of Purchaser and its Affiliates contained in this Agreement shall also inure to the benefit of such manufacturer of API.
|
If to Plantex:
|
Plantex USA Inc.
|
PLANTEXUSA Inc.
|
The Medicines Company
|
signature: /
s/George Svokos
__________________
name:
George Svokos
title:
President
|
signature: _
/s/ Glenn Sblendorio
______________
name: _
Glenn Sblendorio
________________
title:
EVP & CFO
_______________________
|
signature:
/s/ Henit Lapid Ben Ari
______________
name:
Henit Lapid Ben Ari
title:
Director of Sales and Marketing
|
|
Date: ____
Sept. 29
________, 2011
|
Date: ____
Sept. 30
________, 2011
|
Tests and Limits
|
1.
Characters
1.1Appearance
[**]
2.
Identification
[**]
3
Tests
[**]
|
|
[**]
8.0
Assay
[**]
|
PO
000924-A
(Revised) |
|
|
September 15, 2011
|
|
|
|
|
||
Vendor
|
|
The Medicines Company
|
||
Plantex
400 Chestnut Ridge Road
Woodcliff Lake, NJ 07677
|
|
Accounts Payable
8 Sylvan Way
Parsippany, NJ 07054
United States
|
||
|
|
|
Ship To
|
|
|
|
|
The Medicines Company
8 Sylvan Way
Parsippany, NJ 07054
|
|
Product
|
Description
|
Quantity
|
Unit Price
|
Total Price
|
API Bivalirudin
|
Purchase of API
(bivalirudin) |
[**]
grams |
$ [**]/gram
|
$ [**]
|
|
|
|
Tax
|
$0
|
|
|
|
Total
|
$ [**]
|
|
|
|
|
|
Coding
|
|
|
|
|
Cost Center
|
Account
|
Sub-Account
|
Project
|
|
[**]
|
[**]
|
0
|
0
|
|
|
|
|
|
|
Special Terms
|
|
|
|
|
•
Firm order subject to signing of Settlement Agreement, License Agreement, and API Supply Agreement (collectively, the “Agreements”) on or before September 30, 2011. Purchase Order will cancel if the Agreements are not signed on or before September 30, 2011.
•
Availability of up to [**] grams on or before [**]. Balance of purchase order available on or before [**].
•
The terms of the delivery of the quantities specified in section 2 of the terms in this Purchase Order are in accord with the terms of the Supply Agreement.
•
Invoicing of the of the quantities specified in section 2 of the terms in this Purchase Order are in accord with the terms of the Supply Agreement
•
MDCO shall take title and risk of loss of the product upon invoicing by Teva.
•
MDCO requests that the product be stored under GMP conditions at one of Teva’s facilities until picked up by MDCO.
•
MDCO will pick up the all product under this Purchase Order upon its request but in any event no later than [**].
|
All invoices in reference to this purchase order should be mailed to the address specified above, or emailed to
ap@themedco.com
. Please include the following information on all invoices:
|
|
|
PO Number
Care of: Accounts Payable
Cost Center – If Specified in the PO
Account – If Specified in the PO
Sub-Account – If Specified in the PO
Project Code – If specified on the PO
|
Plantex
|
/s/ Glenn Sblendorio
The Medicines Company
|
A.
|
MDCO and Distributor are parties to a Second Amended and Restated Distribution Agreement effective as of October 1, 2010 (the “Agreement”);
|
B.
|
Pursuant to the Agreement, among other things, MDCO engaged Distributor to perform distribution services for certain of MDCO’s pharmaceutical products; and
|
C.
|
The parties now wish to amend the Agreement in certain respects.
|
1.
|
Defined Terms
. Capitalized terms in this Amendment that are not defined in this Amendment have the meanings given to them in the Agreement. If there is any conflict between the Agreement and any provision of this Amendment, this Amendment will control.
|
2.
|
Confidentiality
. Section 8.0 of the Agreement is deleted in its entirety and replaced with the following:
|
3.
|
Schedule A
. Schedule A to the Agreement is deleted in its entirety and replaced with the attached Revised Schedule A.
|
4.
|
Section 16.0
. A new Section 16.0 is added to the Agreement as follows:
|
16.1
|
The Parties acknowledge that Distributor has performed the services set forth in Section 3.3 under the trade name “The Medicines Company Direct” and using registered trademarks belonging to MDCO, and that MDCO authorized and consented to Distributor performing these services and activities in this manner. Distributor expressly acknowledges and agrees that such prior use did not and does not confer to Distributor any patent right, copyright right, trademark right or other proprietary right of MDCO, and that MDCO is the exclusive owner of all such rights.
|
16.2
|
Effective on July 1, 2011 (the “Transition Date”), Distributor will cease using the trade name “The Medicines Company Direct” or any trademark, source mark, logo, name, word, phrase, symbol, design, or image belonging to MDCO, or any combination of these elements (individually and collectively referred to as “MDCO Mark”), for any purpose, except as provided in Section 16.4. For clarification only, Distributor hereby conveys to MDCO all right, title and interests of any kind, including all associated good will, to the mark “The Medicines Company Direct” and any registrations or applications for registration of such mark, and the right to recover for past infringement of such mark. Distributor agrees that it will not attach the title of MDCO in and to any MDCO Mark. Distributor will file appropriate withdrawals of any assumed name or DBA certificates with state regulatory authorities.
|
16.3
|
MDCO hereby grants a limited, non-exclusive, royalty-free, non-transferable license to Distributor to use the MDCO Mark in the Territory solely in Distributor’s performance of the obligations contemplated under this Agreement. The license granted in this Section 16.3 shall terminate effective on the Transition Date, except with respect to the matter described in Section 16.4.
|
16.4
|
Distributor has previously informed customers and regulators that drug pedigrees for Products sold before the Transition Date are available at
www.themedicinescompanydirect.com
. MDCO acknowledges that, to enable Distributor to remain in compliance with applicable pedigree laws
s
Distributor will be permitted to redirect customers that attempt to access that website to Distributor’s standard pedigree website,
www.TMCDirectOrders.com
.
|
5.
|
Exhibit D
. Section E of
Exhibit D
of the Agreement is deleted in its entirety and replaced with the following:
|
6.
|
No Other Changes
. Except as otherwise provided in this Amendment, the terms and
|
By:
/s/ Doug Cook
|
By:
/s/ Tanya Quinn
|
Name:
Doug Cook
|
Name:
Tanya Quinn
|
Title:
VP, General Manager
|
Title:
VP, Global Distribution & Customer Service
|
A.
|
MDCO and Distributor are parties to a Second Amended and Restated Distribution Agreement effective as of October 1, 2010, as amended by the First Amendment dated July 1, 2011 (the “Agreement”);
|
B.
|
Pursuant to the Agreement, among other things, MDCO engaged Distributor to perform distribution services for certain of MDCO's pharmaceutical products; and
|
C.
|
The Parties now wish to amend the Agreement in certain respects.
|
1.
|
Defined Terms
. Capitalized terms in this Amendment that are not defined in this Amendment have the meanings given to them in the Agreement. If there is any conflict between the Agreement and any provision of this Amendment, this Amendment will control.
|
2.
|
Section 6.1
. Section 6.1 of the Agreement is deleted in its entirety and replaced with the following:
|
3.
|
Exhibit B
. The Parties agree that Exhibit B to the Agreement is hereby deleted in its entirety and replaced with the attached Revised Exhibit B.
|
4.
|
Exhibit D
, The Parties agree that Exhibit D to the Agreement is hereby deleted in its entirety and replaced with the attached Revised Exhibit D.
|
5.
|
No Other Changes
. Except as otherwise provided in this Amendment, the terms and conditions of the Agreement will continue in full force, nothing in the Amendment modifies any term or provision in the Agreement or the Continuing Guaranty.
|
INTEGRATED COMMERCIALIZATION
SOLUTIONS, INC.
By:
/s/ Doug Cook
Name:
Doug Cook
Title:
VP, General Manager
|
THE MEDICINES COMPANY
By:
/s/ Tanya Quinn
Name:
Tanya Quinn
Title:
9/13/11
|
Product Name:
NDC#:
Drug Type:
Sellable Package Size:
Dosage Form:
Current WAC Price*:
Case Pack Size
Shipping and Storage Requirements:
|
ANGIOMAX® (bivalirudin) for Injection
65293-001-01
RX
Carton (10 single use vials)
250mg vial
$[**] per Carton, (*which may change from time to time at MDCO's sole discretion)
Thirty (30) Cartons
20 to 25°C
|
Product Name:
NDC#:
Drug Type:
Sellable Package Size:
Dosage Form:
Current WAC Price*:
Case Pack Size
Shipping and Storage Requirements:
|
ANGIOMAX® (bivalirudin) Nova Plus for Injection
65293-004-22
RX
Carton (10 single use vials)
250mg vial
$[**] per Carton, (*which may change from time to time at MDCO's sole discretion)
Thirty (30) Cartons
20 to 25°C
|
|
Product Name:
NDC#:
Drug Type:
Sellable Package Size:
Dosage Form:
Current WAC Price*:
Case Pack Size
Shipping and Storage Requirements:
|
Cleviprex® (clevidipine butyrate) Injectable Emulsion
65293-002-011
RX
Carton (10 single use vials)
50mg vial
$[**] per Carton, (*which may change from time to time at MDCO's sole discretion)
Six (6) Cartons
2 to 8°C
|
|
Product Name:
NDC#:
Drug Type:
Sellable Package Size:
Dosage Form:
Current WAC Price*:
Case Pack Size
Shipping and Storage Requirements:
|
Cleviprex® (clevidipine butyrate) Injectable Emulsion
65293-002-055
RX
Carton (10 single use vials)
25mg vial
$[**] per Carton, (*which may change from time to time at MDCO's sole discretion)
Twelve (12) Cartons
2 to 8°C
|
Product Name:
NDC#:
Drug Type:
Sellable Package Size:
Dosage Form:
Current WAC Price*:
Case Pack Size
Shipping and Storage Requirements:
|
ARGATROBAN for Injection
42367-203-84
RX
Carton (10 single use vials)
50mg vial
$[**] Carton, (*which may change from time to time at MDCO's sole discretion)
Four (4) Cartons
20 to 25°C
|
|
Product Name:
NDC#:
Drug Type:
Sellable Package Size:
Dosage Form:
Current WAC Price*:
Case Pack Size
Shipping and Storage Requirements:
|
Cleviprex® (clevidipine) Injectable Emulsion
65293-005-11
RX
Carton (10 single use vials)
50mg vial
$[**] Carton, (*which may change from time to time at MDCO's sole discretion)
Six (6) Cartons
2 to 8°C
|
|
Product Name:
NDC#:
Drug Type:
Sellable Package Size:
Dosage Form:
Current WAC Price*:
Case Pack Size
Shipping and Storage Requirements:
|
Cleviprex® (clevidipine) Injectable Emulsion
65293-005-55
RX
Carton (10 single use vials)
25mg vial
$[**] Carton, (*which may change from time to time at MDCO's sole discretion)
Twelve (12) Cartons
2 to 8°C
|
Services
A. Marketing, Sales, Customer Service and Distribution
Fees include the following
Warehousing Management and Inventory Administration
Customer Service / Order Entry
Marketing and Distribution Services
Invoicing and Accounts Receivable Management
Direct Account Set Up
Information Technology
|
Fee
Percentage of WAC
(see below)
|
||
Wholesaler Restock and Drop Shipments
October 1, 2010 - September 30, 2011
Angiomax and Angiomax NovaPIus
Cleviprex
|
Percent of WAC
[**]%
[**]%
|
||
October 1, 2011 - September 30, 2013
Angiomax and Angiomax NovaPIus
Cleviprex
September 1, 2011 - September 30, 2013
Argatroban
|
Percent of WAC
[**]%
[**]%
Percent of WAC
[**]%
|
||
Shipment to Direct Account End-Users
October 1, 2010 - September 30, 2011
Angiomax and Angiomax NovaPIus
Cleviprex
September 1, 2011 - September 30, 2013
Argatroban
|
Percent of WAC
[**]%
[**]%
Percent of WAC
[**]%
|
||
**Direct to End-User Fee - Cleviprex Only
***Freight Upcharge (does not include Cleviprex)
|
$[**]/shipment
additional fee MDCO to reimburse Distributor for upgrade From Ground to Next Day Saver or Next Day Air |
B.
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Contract Pricing (provided in Section 5.4)
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C.
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Pricing Actions
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D.
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Early Renewal Incentive
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1.
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I have reviewed this Quarterly Report on Form 10-Q of The Medicines Company;
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2.
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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.
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The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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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;
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c)
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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 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 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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|
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/s/ Clive A. Meanwell
|
|
|
|
Clive A. Meanwell
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|
|
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Chairman and Chief Executive Officer
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Dated:
|
November 9, 2011
|
|
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of The Medicines Company;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
|
5.
|
The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
|
|
|
|
/s/ Glenn P. Sblendorio
|
|
|
|
Glenn P. Sblendorio
|
|
|
|
Executive Vice President and Chief Financial Officer
|
Dated:
|
November 9, 2011
|
|
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
|
|
|
By:
|
/s/ Clive A. Meanwell
|
|
|
|
|
Clive A. Meanwell
|
|
|
|
|
Chairman and Chief Executive Officer
|
Dated:
|
November 9, 2011
|
|
|
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
|
|
|
By:
|
/s/ Glenn P. Sblendorio
|
|
|
|
|
Glenn P. Sblendorio
|
|
|
|
|
Executive Vice President and Chief Financial Officer
|
Dated:
|
November 9, 2011
|
|
|
|