þ
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (No Fee Required)
|
Delaware
(State or other jurisdiction of
incorporation or organization)
|
|
04-3324394
(I.R.S. Employer
Identification No.)
|
|
|
|
8 Sylvan Way
Parsippany, New Jersey
(Address of principal executive offices)
|
|
07054
(Zip Code)
|
Large accelerated filer
þ
|
Accelerated filer
o
|
Non-accelerated filer
o
|
Smaller reporting company
o
|
|
|
(Do not check if a smaller reporting company)
|
|
Part I. Financial Information
|
|
EX-10.1
|
|
EX-10.2
|
|
EX-10.3
|
|
EX-31.1
|
|
EX-31.2
|
|
EX-32.1
|
|
EX-32.2
|
|
|
September 30,
2013 |
|
December 31,
2012 |
||||
ASSETS
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
462,360
|
|
|
$
|
519,446
|
|
Available for sale securities
|
—
|
|
|
50,875
|
|
||
Accrued interest receivable
|
—
|
|
|
348
|
|
||
Accounts receivable, net of allowances of approximately $29.1 million and $17.7 million at September 30, 2013 and December 31, 2012, respectively
|
103,757
|
|
|
85,893
|
|
||
Inventory
|
91,499
|
|
|
76,355
|
|
||
Deferred tax assets
|
13,889
|
|
|
13,881
|
|
||
Prepaid expenses and other current assets
|
12,165
|
|
|
9,577
|
|
||
Total current assets
|
683,670
|
|
|
756,375
|
|
||
Fixed assets, net
|
33,926
|
|
|
16,100
|
|
||
Intangible assets, net
|
622,274
|
|
|
119,576
|
|
||
Goodwill
|
186,821
|
|
|
14,671
|
|
||
Restricted cash
|
1,577
|
|
|
1,571
|
|
||
Deferred tax assets, net
|
—
|
|
|
46,625
|
|
||
Other assets
|
17,296
|
|
|
17,264
|
|
||
Total assets
|
$
|
1,545,564
|
|
|
$
|
972,182
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
32,766
|
|
|
$
|
25,378
|
|
Accrued expenses
|
133,600
|
|
|
107,453
|
|
||
Deferred revenue
|
3,980
|
|
|
2,375
|
|
||
Total current liabilities
|
170,346
|
|
|
135,206
|
|
||
Contingent purchase price
|
188,554
|
|
|
18,971
|
|
||
Deferred tax liabilities
|
78,369
|
|
|
—
|
|
||
Convertible senior notes (due 2017)
|
233,544
|
|
|
226,109
|
|
||
Other liabilities
|
5,863
|
|
|
5,674
|
|
||
Total liabilities
|
676,676
|
|
|
385,960
|
|
||
Stockholders' equity:
|
|
|
|
||||
Preferred stock, $1.00 par value per share, 5,000,000 shares authorized; no shares issued and outstanding
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value per share, 125,000,000 shares authorized; 65,886,509 issued and 63,693,527 outstanding at September 30, 2013 and 56,153,140 issued and 53,960,158 outstanding at December 31, 2012, respectively
|
66
|
|
|
56
|
|
||
Additional paid-in capital
|
968,067
|
|
|
697,427
|
|
||
Treasury stock, at cost; 2,192,982 shares at September 30, 2013 and December 31, 2012, respectively
|
(50,000
|
)
|
|
(50,000
|
)
|
||
Accumulated deficit
|
(46,097
|
)
|
|
(60,411
|
)
|
||
Accumulated other comprehensive loss
|
(2,923
|
)
|
|
(766
|
)
|
||
Total The Medicines Company stockholders' equity
|
869,113
|
|
|
586,306
|
|
||
Non-controlling interest in joint venture
|
(225
|
)
|
|
(84
|
)
|
||
Total stockholders' equity
|
868,888
|
|
|
586,222
|
|
||
Total liabilities and stockholders' equity
|
$
|
1,545,564
|
|
|
$
|
972,182
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
Net revenue
|
$
|
174,282
|
|
|
$
|
136,786
|
|
|
$
|
502,861
|
|
|
$
|
399,098
|
|
Operating expenses:
|
|
|
|
|
|
|
|
||||||||
Cost of revenue
|
65,794
|
|
|
43,767
|
|
|
186,446
|
|
|
125,111
|
|
||||
Research and development
|
23,187
|
|
|
34,536
|
|
|
108,408
|
|
|
100,276
|
|
||||
Selling, general and administrative
|
62,528
|
|
|
43,396
|
|
|
178,954
|
|
|
127,049
|
|
||||
Total operating expenses
|
151,509
|
|
|
121,699
|
|
|
473,808
|
|
|
352,436
|
|
||||
Income from operations
|
22,773
|
|
|
15,087
|
|
|
29,053
|
|
|
46,662
|
|
||||
Co-promotion income
|
4,423
|
|
|
3,750
|
|
|
12,241
|
|
|
6,250
|
|
||||
Interest expense
|
(3,765
|
)
|
|
(3,605
|
)
|
|
(11,143
|
)
|
|
(4,389
|
)
|
||||
Other income
|
383
|
|
|
204
|
|
|
1,186
|
|
|
963
|
|
||||
Income before income taxes
|
23,814
|
|
|
15,436
|
|
|
31,337
|
|
|
49,486
|
|
||||
Provision for income taxes
|
(16,068
|
)
|
|
(6,172
|
)
|
|
(17,163
|
)
|
|
(18,897
|
)
|
||||
Net income
|
7,746
|
|
|
9,264
|
|
|
14,174
|
|
|
30,589
|
|
||||
Net loss attributable to non-controlling interest
|
47
|
|
|
1
|
|
|
140
|
|
|
2
|
|
||||
Net income attributable to The Medicines Company
|
$
|
7,793
|
|
|
$
|
9,265
|
|
|
$
|
14,314
|
|
|
$
|
30,591
|
|
Basic earnings per common share attributable to The Medicines Company
|
$
|
0.13
|
|
|
$
|
0.18
|
|
|
$
|
0.25
|
|
|
$
|
0.57
|
|
Diluted earnings per common share attributable to The Medicines Company
|
$
|
0.12
|
|
|
$
|
0.17
|
|
|
$
|
0.24
|
|
|
$
|
0.55
|
|
Weighted average number of common shares outstanding:
|
|
|
|
|
|
|
|
||||||||
Basic
|
59,231
|
|
|
52,896
|
|
|
56,296
|
|
|
53,653
|
|
||||
Diluted
|
63,173
|
|
|
55,145
|
|
|
60,510
|
|
|
55,455
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
Net income
|
$
|
7,746
|
|
|
$
|
9,264
|
|
|
$
|
14,174
|
|
|
$
|
30,589
|
|
Other comprehensive (loss) income:
|
|
|
|
|
|
|
|
||||||||
Unrealized (loss) gain on available for sale securities
|
(5
|
)
|
|
55
|
|
|
(10
|
)
|
|
32
|
|
||||
Foreign currency translation adjustment
|
(1,234
|
)
|
|
453
|
|
|
(2,147
|
)
|
|
(181
|
)
|
||||
Other comprehensive (loss) income
|
(1,239
|
)
|
|
508
|
|
|
(2,157
|
)
|
|
(149
|
)
|
||||
Comprehensive income
|
$
|
6,507
|
|
|
$
|
9,772
|
|
|
$
|
12,017
|
|
|
$
|
30,440
|
|
|
Nine Months Ended September 30,
|
||||||
|
2013
|
|
2012
|
||||
Cash flows from operating activities:
|
|
|
|
||||
Net income
|
$
|
14,174
|
|
|
$
|
30,589
|
|
Adjustments to reconcile net income to net cash provided by operating activities:
|
|
|
|
||||
Depreciation and amortization
|
19,968
|
|
|
5,401
|
|
||
Amortization of net premiums and discounts on available for sale securities
|
209
|
|
|
513
|
|
||
Amortization of long term debt financing costs
|
872
|
|
|
326
|
|
||
Amortization of debt discount
|
7,434
|
|
|
2,908
|
|
||
Unrealized foreign currency transaction loss (gain), net
|
124
|
|
|
(498
|
)
|
||
Non-cash stock compensation expense
|
15,910
|
|
|
11,132
|
|
||
Loss on disposal of fixed assets
|
32
|
|
|
46
|
|
||
Deferred tax provision
|
(3,390
|
)
|
|
8,233
|
|
||
Excess tax benefit from share-based compensation arrangements
|
(5,971
|
)
|
|
(1,052
|
)
|
||
Adjustment to contingent purchase price
|
(168
|
)
|
|
2,202
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accrued interest receivable
|
347
|
|
|
(40
|
)
|
||
Accounts receivable
|
(17,806
|
)
|
|
(8,852
|
)
|
||
Inventory
|
(15,098
|
)
|
|
(17,189
|
)
|
||
Prepaid expenses and other current assets
|
(2,205
|
)
|
|
(1,334
|
)
|
||
Accounts payable
|
5,970
|
|
|
(38
|
)
|
||
Accrued expenses
|
27,409
|
|
|
(12,955
|
)
|
||
Deferred revenue
|
1,594
|
|
|
1,164
|
|
||
Other liabilities
|
181
|
|
|
137
|
|
||
Net cash (used in) provided by operating activities
|
49,586
|
|
|
20,693
|
|
||
Cash flows from investing activities:
|
|
|
|
||||
Purchases of available for sale securities
|
—
|
|
|
(65,354
|
)
|
||
Proceeds from maturities and sales of available for sale securities
|
50,656
|
|
|
25,036
|
|
||
Purchases of fixed assets
|
(7,688
|
)
|
|
(695
|
)
|
||
Acquisitions, net of cash acquired
|
(402,579
|
)
|
|
—
|
|
||
Acquisition of intangible assets
|
—
|
|
|
(36,678
|
)
|
||
Other investments
|
(875
|
)
|
|
(500
|
)
|
||
Decrease in restricted cash
|
2
|
|
|
3,148
|
|
||
Net cash used in investing activities
|
(360,484
|
)
|
|
(75,043
|
)
|
||
Cash flows from financing activities:
|
|
|
|
||||
Proceeds from issuances of common stock
|
59,169
|
|
|
21,606
|
|
||
Proceeds from equity offering, net
|
189,600
|
|
|
—
|
|
||
Purchase of treasury stock
|
—
|
|
|
(50,000
|
)
|
||
Proceeds from issuance of convertible senior notes
|
—
|
|
|
275,000
|
|
||
Proceeds from issuance of warrants
|
—
|
|
|
38,425
|
|
||
Purchase of convertible note hedge
|
—
|
|
|
(58,223
|
)
|
||
Debt issuance costs
|
—
|
|
|
(8,774
|
)
|
||
Excess tax benefit from stock-based compensation arrangements
|
5,971
|
|
|
1,052
|
|
||
Net cash provided by financing activities
|
254,740
|
|
|
219,086
|
|
||
Effect of exchange rate changes on cash
|
(928
|
)
|
|
271
|
|
||
(Decrease) increase in cash and cash equivalents
|
(57,086
|
)
|
|
165,007
|
|
||
Cash and cash equivalents at beginning of period
|
519,446
|
|
|
315,382
|
|
||
Cash and cash equivalents at end of period
|
$
|
462,360
|
|
|
$
|
480,389
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
||||
Interest paid
|
$
|
1,891
|
|
|
$
|
—
|
|
Taxes paid
|
$
|
2,500
|
|
|
$
|
1,155
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
(in thousands, except per share amounts)
|
||||||||||||||
Basic and diluted
|
|
|
|
|
|
|
|
||||||||
Net income attributable to The Medicines Company
|
$
|
7,793
|
|
|
$
|
9,265
|
|
|
$
|
14,314
|
|
|
$
|
30,591
|
|
|
|
|
|
|
|
|
|
||||||||
Weighted average common shares outstanding, basic
|
59,231
|
|
|
52,896
|
|
|
56,296
|
|
|
53,653
|
|
||||
Plus: net effect of dilutive stock options, restricted common shares and shares issuable upon conversion of Notes
|
3,942
|
|
|
2,249
|
|
|
4,214
|
|
|
1,802
|
|
||||
Weighted average common shares outstanding, diluted
|
63,173
|
|
|
55,145
|
|
|
60,510
|
|
|
55,455
|
|
||||
|
|
|
|
|
|
|
|
||||||||
Earnings per share attributable to The Medicines Company, basic
|
$
|
0.13
|
|
|
$
|
0.18
|
|
|
$
|
0.25
|
|
|
$
|
0.57
|
|
Earnings per share attributable to The Medicines Company, diluted
|
$
|
0.12
|
|
|
$
|
0.17
|
|
|
$
|
0.24
|
|
|
$
|
0.55
|
|
|
As of September 30, 2013
|
|
As of December 31, 2012
|
||||||||||||||||||||||||||||
|
Cost
|
|
Fair Value
|
|
Carrying
Value
|
|
Unrealized
Gain
|
|
Cost
|
|
Fair Value
|
|
Carrying
Value
|
|
Unrealized
Gain
|
||||||||||||||||
|
(in thousands)
|
||||||||||||||||||||||||||||||
U.S. government agency notes
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
7,093
|
|
|
$
|
7,097
|
|
|
$
|
7,097
|
|
|
$
|
4
|
|
Corporate debt securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
43,772
|
|
|
43,778
|
|
|
43,778
|
|
|
6
|
|
||||||||
Total
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
50,865
|
|
|
$
|
50,875
|
|
|
$
|
50,875
|
|
|
$
|
10
|
|
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. Fair values are determined by utilizing quoted prices for similar assets and liabilities in active markets or other market observable inputs such as interest rates and yield curves.
|
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 prices associated with the Company's acquisitions of Targanta, Incline and ProFibrix. The fair value of the contingent purchase prices was determined utilizing a probability weighted discounted financial model based on management's assessment of the likelihood of achievement of certain development, regulatory and sales milestones.
|
|
As of September 30, 2013
|
|
As of December 31, 2012
|
||||||||||||||||||||||||||||
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 as of September 30, 2013
|
|
Quoted Prices In
Active Markets for Identical Assets
(Level 1)
|
|
Significant Other Observable Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
Balance as of December 31, 2012
|
||||||||||||||||
|
(in thousands)
|
||||||||||||||||||||||||||||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Money market
|
$
|
46,019
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
46,019
|
|
|
$
|
14,751
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
14,751
|
|
U.S. government agency notes
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,097
|
|
|
—
|
|
|
7,097
|
|
||||||||
Corporate debt securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
43,778
|
|
|
—
|
|
|
43,778
|
|
||||||||
Total assets at fair value
|
$
|
46,019
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
46,019
|
|
|
$
|
14,751
|
|
|
$
|
50,875
|
|
|
$
|
—
|
|
|
$
|
65,626
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Contingent purchase price
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
188,554
|
|
|
$
|
188,554
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
18,971
|
|
|
$
|
18,971
|
|
Total liabilities at fair value
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
188,554
|
|
|
$
|
188,554
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
18,971
|
|
|
$
|
18,971
|
|
|
||||||||||
|
|
Fair Value as of
|
|
|
|
|
|
|
||
|
|
September 30, 2013
|
|
Valuation Technique
|
|
Unobservable Input
|
|
Range
(Weighted Average)
|
||
|
|
(in thousands)
|
|
|
|
|
|
|
||
Targanta:
|
|
|
|
|
|
|
|
|
||
Contingent purchase price
|
|
$
|
5,424
|
|
|
Probability-adjusted discounted cash flow
|
|
Probability of success
|
|
20%
|
|
|
|
|
|
|
Period in which milestone is expected to be achieved
|
|
2019
|
||
|
|
|
|
|
|
Discount rate
|
|
11%
|
||
Incline:
|
|
|
|
|
|
|
|
|
||
Contingent purchase price
|
|
$
|
99,900
|
|
|
Probability-adjusted discounted cash flow
|
|
Probabilities of success
|
|
60% - 80% (75%)
|
|
|
|
|
|
|
Periods in which milestones are expected to be achieved
|
|
2013-2017
|
||
|
|
|
|
|
|
Discount Rate
|
|
22%
|
||
ProFibrix:
|
|
|
|
|
|
|
|
|
||
Contingent purchase price
|
|
$
|
83,230
|
|
|
Probability-adjusted discounted cash flow
|
|
Probability of success
|
|
5% - 95% (91%)
|
|
|
|
|
|
|
Period in which milestones are expected to be achieved
|
|
2015 - 2017
|
||
|
|
|
|
|
|
Discount rate
|
|
4.9% - 17.5%
|
|
|
Fair Value as of
|
|
|
|
|
|
|
||
|
|
December 31, 2012
|
|
Valuation Technique
|
|
Unobservable Input
|
|
Range
(Weighted Average)
|
||
|
|
(in thousands)
|
|
|
|
|
|
|
||
Targanta:
|
|
|
|
|
|
|
|
|
||
Contingent purchase price
|
|
$
|
18,971
|
|
|
Probability-adjusted discounted cash flow
|
|
Probabilities of success
|
|
20% - 60% (49%)
|
|
|
|
|
|
|
Periods in which milestones are expected to be achieved
|
|
2013 - 2019
|
||
|
|
|
|
|
|
Discount rate
|
|
11%
|
|
||||||||||||||||
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
|
(in thousands)
|
|
|
|
|
||||||||||
Balance at beginning of period
|
|
$
|
100,524
|
|
|
$
|
21,568
|
|
|
$
|
18,971
|
|
|
$
|
20,431
|
|
Fair value of contingent purchase price with respect to Incline as of January 4, 2013
|
|
—
|
|
|
—
|
|
|
87,200
|
|
|
—
|
|
||||
Fair value of contingent purchase price with respect to ProFibrix as of August 5, 2013
|
|
82,550
|
|
|
|
|
82,550
|
|
|
|
||||||
Fair value adjustment to contingent purchase prices included in net income
|
|
5,480
|
|
|
1,065
|
|
|
(167
|
)
|
|
2,202
|
|
||||
Balance at end of period
|
|
$
|
188,554
|
|
|
$
|
22,633
|
|
|
$
|
188,554
|
|
|
$
|
22,633
|
|
Inventory
|
|
September 30,
2013 |
|
December 31,
2012 |
||||
|
|
(in thousands)
|
||||||
Raw materials
|
|
$
|
45,024
|
|
|
$
|
40,244
|
|
Work-in-progress
|
|
25,546
|
|
|
26,594
|
|
||
Finished goods
|
|
20,929
|
|
|
9,517
|
|
||
Total
|
|
$
|
91,499
|
|
|
$
|
76,355
|
|
|
As of September 30, 2013
|
|
As of December 31, 2012
|
||||||||||||||||||||||
|
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
|
8 years
|
|
$
|
7,457
|
|
|
$
|
(5,250
|
)
|
|
$
|
2,207
|
|
|
$
|
7,457
|
|
|
$
|
(4,106
|
)
|
|
$
|
3,351
|
|
Selling rights agreements
|
5.7 years
|
|
9,125
|
|
|
(5,270
|
)
|
|
3,855
|
|
|
9,125
|
|
|
(3,469
|
)
|
|
5,656
|
|
||||||
Trademarks
|
8 years
|
|
3,024
|
|
|
(2,129
|
)
|
|
895
|
|
|
3,024
|
|
|
(1,665
|
)
|
|
1,359
|
|
||||||
Product licenses
|
5.7 years
|
|
71,000
|
|
|
(14,999
|
)
|
|
56,001
|
|
|
39,000
|
|
|
(1,129
|
)
|
|
37,871
|
|
||||||
Cleviprex milestones
|
13 years
|
|
2,000
|
|
|
(184
|
)
|
|
1,816
|
|
|
2,000
|
|
|
(161
|
)
|
|
1,839
|
|
||||||
Total
|
6.1 years
|
|
$
|
92,606
|
|
|
$
|
(27,832
|
)
|
|
$
|
64,774
|
|
|
$
|
60,606
|
|
|
$
|
(10,530
|
)
|
|
$
|
50,076
|
|
|
As of September 30, 2013
|
|
As of December 31, 2012
|
||||||||||||||||||
|
Gross
Carrying
Amount
|
|
Adjustments
|
|
Net
Carrying
Amount
|
|
Gross
Carrying
Amount
|
|
Adjustments
|
|
Net
Carrying
Amount
|
||||||||||
|
(in thousands)
|
||||||||||||||||||||
Intangible assets not subject to amortization:
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
In-process research and development
|
$
|
495,500
|
|
|
—
|
|
|
$
|
495,500
|
|
|
$
|
69,500
|
|
|
—
|
|
|
$
|
69,500
|
|
Recothrom option
|
62,000
|
|
|
—
|
|
|
62,000
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||
Total
|
$
|
557,500
|
|
|
—
|
|
|
$
|
557,500
|
|
|
$
|
69,500
|
|
|
—
|
|
|
$
|
69,500
|
|
|
September 30, 2013
|
|
|
||
|
(in thousands)
|
|
|||
Balance at January 1, 2013
|
$
|
14,671
|
|
|
|
Goodwill resulting from the acquisition of Incline
|
99,956
|
|
|
|
|
Goodwill resulting from the acquisition of Recothrom
|
21,000
|
|
|
|
|
Goodwill resulting from the acquisition of ProFibrix
|
51,311
|
|
|
|
|
Translation adjustments
|
(117
|
)
|
|
|
|
Balance as of September 30, 2013
|
$
|
186,821
|
|
|
|
•
|
during any calendar quarter commencing on or after
September 1, 2012
(and only during such calendar quarter), if the last reported sale price of the Company's common stock for at least
20
trading days (whether or not consecutive) during a period of
30
consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to
130%
of the conversion price (described below) on each applicable trading day;
|
•
|
during the five business day period after any
five
consecutive trading day period (the Measurement Period) in which the trading price (as defined in the Indenture) per
$1,000
principal amount of Notes for each trading day of the Measurement Period was less than
98%
of the product of the last reported sale price of the Company's common stock and the conversion rate on each such trading day; or
|
•
|
upon the occurrence of specified corporate events, including a merger or a sale of all or substantially all of the Company's assets.
|
Liability component
|
|
September 30,
2013 |
|
December 31,
2012 |
||||
|
|
(in thousands)
|
||||||
Principal
|
|
$
|
275,000
|
|
|
$
|
275,000
|
|
Less: Debt discount, net
(1)
|
|
(41,456
|
)
|
|
(48,891
|
)
|
||
Net carrying amount
|
|
$
|
233,544
|
|
|
$
|
226,109
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
(in thousands)
|
|
|
|
|
||||||||||
Contractual interest expense
|
$
|
945
|
|
|
$
|
949
|
|
|
$
|
2,836
|
|
|
$
|
1,156
|
|
|
|
|
|
|
|
|
|
||||||||
Amortization of debt issuance costs
|
301
|
|
|
268
|
|
|
872
|
|
|
326
|
|
||||
Amortization of debt discount
|
2,519
|
|
|
2,389
|
|
|
7,434
|
|
|
2,908
|
|
||||
Total
|
$
|
3,765
|
|
|
$
|
3,606
|
|
|
$
|
11,142
|
|
|
$
|
4,390
|
|
Effective interest rate of the liability component
|
6.02
|
%
|
|
6.02
|
%
|
|
6.02
|
%
|
|
6.02
|
%
|
|
Balance as of December 31, 2012
|
|
Expenses, Net
|
|
Cash
|
|
Noncash
|
|
Balance as of September 30, 2013
|
||||||||||
|
(in thousands)
|
||||||||||||||||||
2011 Leipzig closure other associated costs
|
$
|
1,009
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(1,009
|
)
|
|
$
|
—
|
|
Employee severance and other personnel benefits:
|
|
|
|
|
|
|
|
|
|
||||||||||
2013 workforce reduction
|
—
|
|
|
6,358
|
|
|
(5,647
|
)
|
|
(289
|
)
|
|
422
|
|
|||||
Total
|
$
|
1,009
|
|
|
$
|
6,358
|
|
|
$
|
(5,647
|
)
|
|
$
|
(1,298
|
)
|
|
$
|
422
|
|
|
|
(in thousands)
|
||
Upfront cash consideration
|
|
$
|
186,699
|
|
Fair value of contingent purchase price
|
|
87,200
|
|
|
Total preliminary estimated purchase price
|
|
$
|
273,899
|
|
|
|
|
|
|
|
||
Assets Acquired:
|
|
(in thousands)
|
||
Cash and cash equivalents
|
|
$
|
1,563
|
|
Prepaid expenses and other current assets
|
|
624
|
|
|
Fixed assets, net
|
|
12,577
|
|
|
In-process research and development
|
|
250,000
|
|
|
Goodwill
|
|
99,956
|
|
|
Other assets
|
|
34
|
|
|
Total Assets
|
|
$
|
364,754
|
|
Liabilities Assumed:
|
|
|
||
Accrued expenses
|
|
$
|
1,413
|
|
Contingent purchase price
|
|
87,200
|
|
|
Deferred tax liabilities
|
|
89,442
|
|
|
Total Liabilities
|
|
$
|
178,055
|
|
|
|
|
||
Total cash price paid upon acquisition
|
|
$
|
186,699
|
|
•
|
a multiple of average net sales over each of the
two
12
-month periods preceding the closing of the purchase (unless the purchase closing occurs less than 24 months after February 8, 2013, in which case the measurement period would be the 12-month period preceding the purchase closing); or
|
•
|
if BMS has delivered a valid notice terminating the collaboration term early as a result of a material breach by the Company under the master transaction agreement, the amount described above plus an amount intended to give BMS the economic benefit of having received royalty fees for a
24
-month collaboration term.
|
|
|
|
||
Assets Acquired:
|
|
(in thousands)
|
||
Product license
|
|
$
|
32,000
|
|
Option
|
|
62,000
|
|
|
Goodwill
|
|
21,000
|
|
|
Total Assets
|
|
$
|
115,000
|
|
Total cash price paid upon acquisition
|
|
$
|
115,000
|
|
|
|
|
|
|
(in thousands)
|
||
Upfront cash consideration
|
|
$
|
100,879
|
|
Fair value of contingent purchase price
|
|
82,550
|
|
|
Total preliminary estimated purchase price
|
|
$
|
183,429
|
|
|
|
|
|
|
|
||
Assets Acquired:
|
|
(in thousands)
|
||
Fixed assets, net
|
|
$
|
124
|
|
In-process research and development
|
|
176,000
|
|
|
Goodwill
|
|
51,311
|
|
|
Total Assets
|
|
$
|
227,435
|
|
Liabilities Assumed:
|
|
|
||
Contingent purchase price
|
|
$
|
82,550
|
|
Deferred tax liabilities
|
|
44,006
|
|
|
Total Liabilities
|
|
$
|
126,556
|
|
|
|
|
||
Total cash price paid upon acquisition
|
|
$
|
100,879
|
|
|
|
|
|
|
|
|
|
|
||||||||
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
|
(in thousands, except per share amounts)
|
||||||||||||||
Net revenue
|
|
$
|
174,282
|
|
|
$
|
153,398
|
|
|
$
|
509,214
|
|
|
$
|
448,934
|
|
Net (loss) income
|
|
$
|
4,739
|
|
|
$
|
(403
|
)
|
|
$
|
5,569
|
|
|
$
|
(73,131
|
)
|
Basic earnings (loss) per common share
|
|
$
|
0.08
|
|
|
$
|
(0.01
|
)
|
|
$
|
0.10
|
|
|
$
|
(1.36
|
)
|
Diluted earnings (loss) per common share
|
|
$
|
0.08
|
|
|
$
|
(0.01
|
)
|
|
$
|
0.09
|
|
|
$
|
(1.36
|
)
|
|
|
|
||||||||||
|
|
Foreign currency translation adjustment
|
|
Unrealized gain on available for sale securities
|
|
Total
|
||||||
|
|
(in thousands)
|
||||||||||
Balance at December 31, 2012
|
|
$
|
(825
|
)
|
|
$
|
59
|
|
|
$
|
(766
|
)
|
Other comprehensive (loss) income before reclassifications
|
|
(2,147
|
)
|
|
(10
|
)
|
|
(2,157
|
)
|
|||
Amounts reclassified from accumulated other comprehensive income*
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Total other comprehensive (loss) income
|
|
(2,147
|
)
|
|
(10
|
)
|
|
(2,157
|
)
|
|||
Balance at September 30, 2013
|
|
$
|
(2,972
|
)
|
|
$
|
49
|
|
|
$
|
(2,923
|
)
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
||||||||||||||||
|
2013
|
|
|
|
2012
|
|
|
2013
|
|
|
|
2012
|
|
||||||||
|
(in thousands)
|
|
|
|
|
(in thousands)
|
|
||||||||||||||
Net revenue:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
United States
|
$
|
159,193
|
|
|
91.3%
|
|
$
|
126,829
|
|
92.8%
|
|
$
|
462,979
|
|
|
92.1%
|
|
$
|
366,582
|
|
91.9%
|
Europe
|
12,134
|
|
|
7.0%
|
|
7,974
|
|
5.8%
|
|
33,217
|
|
|
6.6%
|
|
26,785
|
|
6.7%
|
||||
Rest of world
|
2,955
|
|
|
1.7%
|
|
1,983
|
|
1.4%
|
|
6,665
|
|
|
1.3%
|
|
5,731
|
|
1.4%
|
||||
Total net revenue
|
$
|
174,282
|
|
|
100.0%
|
|
$
|
136,786
|
|
100.0%
|
|
$
|
502,861
|
|
|
100.0%
|
|
$
|
399,098
|
|
100.0%
|
|
September 30,
2013 |
|
|
|
December 31,
2012 |
|
||||||
|
(in thousands)
|
|
||||||||||
Long-lived assets:
|
|
|
|
|
|
|
||||||
United States
|
$
|
855,222
|
|
|
99.4
|
%
|
|
$
|
161,909
|
|
99.4
|
%
|
Europe
|
1,122
|
|
|
0.1
|
%
|
|
743
|
|
0.5
|
%
|
||
Rest of world
|
3,972
|
|
|
0.5
|
%
|
|
148
|
|
0.1
|
%
|
||
Total long-lived assets
|
$
|
860,316
|
|
|
100.0
|
%
|
|
$
|
162,800
|
|
100.0
|
%
|
Product or Product
in Development
|
|
Development Stage
|
|
Mechanism/Target
|
|
Clinical Indication(s)/Therapeutic Areas
|
Marketed Products
|
|
|
|
|
|
|
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
|
Recothrom
|
|
Marketed in the United States and Canada
|
|
Recombinant human thrombin
|
|
For use as an aid to hemostasis to help control oozing blood and mild bleeding during surgical procedures
|
Cleviprex
|
|
Marketed in the United States and Switzerland
Approved in Australia, Austria, Belgium, Canada, France, Germany, Luxembourg, the Netherlands, Spain and the United Kingdom
Marketing Authorization Application, or MAA, submitted for other European Union countries
|
|
Calcium channel blocker
|
|
U.S. - Blood pressure reduction when oral therapy is not feasible or not desirable
Ex-U.S. - with indications for blood pressure control in perioperative settings
|
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
|
Acute care generic products: Midazolam, Ondansetron and Rocuronium
|
|
Marketed in the United States
|
|
Various
|
|
Neurocritical care
|
Acute care generic products:
Adenosine, Amiodarone, Esmolol and Milrinone
|
|
Approved in the United States
|
|
Various
|
|
Cardiovascular
|
Acute care generic products: Azithromycin and Clindamycin
|
|
Approved in the United States
|
|
Various
|
|
Serious infection
|
Acute care generic products: Haloperidol
|
|
Approved in the United States
|
|
Various
|
|
Neurocritical care
|
Products in Development
|
|
|
|
|
|
|
Cangrelor
|
|
New Drug Application, or NDA, filed in the United States; MAA submission in the European Union planned for the fourth quarter of 2013
|
|
Antiplatelet agent
|
|
Prevention of platelet activation and aggregation when oral therapy is not feasible or not desirable for use in patients undergoing PCI and patients that require bridging from oral antiplatelet therapy to surgery
|
Oritavancin
|
|
Phase 3 completed; NDA submission in the United States planned for the fourth quarter of 2013; MAA submission in the European Union planned for the first half of 2014
|
|
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
|
Fibrocaps
|
|
Phase 3 completed; Biologics License Application, or BLA, submission in the United States planned for the first quarter of 2014; MAA submission in the European Union planned for the fourth quarter of 2013
|
|
Dry powder topical formulation of fibrinogen and thrombin
|
|
For use as an aid to stop bleeding during surgery
|
IONSYS
|
|
Pre-registration stage; Supplemental New Drug Application, or sNDA, submission and MAA submission in European Union planned for the first half of 2014
|
|
Patient-controlled analgesia system
|
|
Short-term management of acute postoperative pain
|
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
|
ALN-PCS program: ALN-PCS02 and ALN-PCSsc
|
|
Phase 1
|
|
PCSK-9 gene antagonist addressing low-density lipoprotein, or LDL, cholesterol disease modification
|
|
Treatment of hypercholesterolemia
|
•
|
a multiple of average net sales over each of the two 12-month periods preceding the closing of the purchase of the assets to be acquired in connection with exercising the option (unless such closing occurs less than 24 months after February 8, 2013, in which case the measurement period would be the 12-month period preceding such closing); or
|
•
|
if BMS has delivered a valid notice terminating the collaboration term early as a result of a material breach by us under the master transaction agreement, the amount described above plus an amount intended to give BMS the economic benefit of having received royalty fees for a 24-month collaboration term.
|
|
Three Months Ended September 30,
|
|||||||||||||
|
2013
|
|
2012
|
|
Change
$
|
|
Change
%
|
|||||||
|
|
|
(in thousands)
|
|
|
|
|
|||||||
Angiomax
|
$
|
153,596
|
|
|
$
|
133,765
|
|
|
$
|
19,831
|
|
|
14.8
|
%
|
Recothrom
|
16,993
|
|
|
—
|
|
|
16,993
|
|
|
100.0
|
%
|
|||
Cleviprex/Ready-to-Use Argatroban
|
3,693
|
|
|
3,021
|
|
|
672
|
|
|
22.2
|
%
|
|||
Total net revenue
|
$
|
174,282
|
|
|
$
|
136,786
|
|
|
$
|
37,496
|
|
|
27.4
|
%
|
|
|
|
|
|
|
|
|
|||||||
|
Nine Months Ended September 30,
|
|||||||||||||
|
2013
|
|
2012
|
|
Change
$
|
|
Change
%
|
|||||||
|
|
|
(in thousands)
|
|
|
|
|
|||||||
Angiomax
|
$
|
447,641
|
|
|
$
|
392,975
|
|
|
$
|
54,666
|
|
|
13.9
|
%
|
Recothrom
|
43,540
|
|
|
—
|
|
|
43,540
|
|
|
100.0
|
%
|
|||
Cleviprex/Ready-to-Use Argatroban
|
11,680
|
|
|
6,123
|
|
|
5,557
|
|
|
90.8
|
%
|
|||
Total net revenue
|
$
|
502,861
|
|
|
$
|
399,098
|
|
|
$
|
103,763
|
|
|
26.0
|
%
|
•
|
expenses in connection with the manufacture of our products sold;
|
•
|
royalty expenses under our agreements with Biogen and Health Research Inc. related to Angiomax, our agreement with AstraZeneca related to Cleviprex and our agreement with Eagle related to ready-to-use Argatroban;
|
•
|
amortization of the costs of license agreements, product rights and other identifiable intangible assets, which result from product and business acquisitions; and
|
•
|
logistics costs related to Angiomax, Cleviprex and ready-to-use Argatroban, including distribution, storage, and handling costs.
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||||||||||||||
|
2013
|
|
% of Total
|
|
2012
|
|
% of Total
|
|
2013
|
|
% of Total
|
|
2012
|
|
% of Total
|
||||||||||||
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||
Manufacturing/Logistics
|
$
|
20,144
|
|
|
30
|
%
|
|
$
|
12,254
|
|
|
28
|
%
|
|
$
|
58,585
|
|
|
32
|
%
|
|
$
|
35,436
|
|
|
28
|
%
|
Royalties
|
40,582
|
|
|
62
|
%
|
|
31,287
|
|
|
71
|
%
|
|
$
|
113,975
|
|
|
61
|
%
|
|
$
|
88,998
|
|
|
71
|
%
|
||
Amortization of product rights and intangible assets
|
5,068
|
|
|
8
|
%
|
|
226
|
|
|
1
|
%
|
|
$
|
13,886
|
|
|
7
|
%
|
|
$
|
677
|
|
|
1
|
%
|
||
Total cost of revenue
|
$
|
65,794
|
|
|
100
|
%
|
|
$
|
43,767
|
|
|
100
|
%
|
|
$
|
186,446
|
|
|
100
|
%
|
|
$
|
125,111
|
|
|
100
|
%
|
|
Three Months Ended September 30,
|
||||||||||||
|
2013
|
|
% of
Total R&D
|
|
2012
|
|
% of
Total R&D
|
||||||
|
(In thousands)
|
|
|
|
(In thousands)
|
|
|
||||||
Angiomax
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
$
|
1,606
|
|
|
7
|
%
|
|
$
|
2,610
|
|
|
8
|
%
|
Manufacturing development
|
50
|
|
|
—
|
%
|
|
14
|
|
|
—
|
%
|
||
Administrative and headcount costs
|
2,750
|
|
|
12
|
%
|
|
939
|
|
|
3
|
%
|
||
Total Angiomax
|
4,406
|
|
|
19
|
%
|
|
3,563
|
|
|
11
|
%
|
||
Cleviprex
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
—
|
|
|
—
|
%
|
|
—
|
|
|
—
|
%
|
||
Manufacturing development
|
—
|
|
|
—
|
%
|
|
95
|
|
|
—
|
%
|
||
Administrative and headcount costs
|
596
|
|
|
3
|
%
|
|
518
|
|
|
1
|
%
|
||
Total Cleviprex
|
596
|
|
|
3
|
%
|
|
613
|
|
|
1
|
%
|
||
Cangrelor
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
124
|
|
|
1
|
%
|
|
11,688
|
|
|
35
|
%
|
||
Manufacturing development
|
631
|
|
|
3
|
%
|
|
53
|
|
|
—
|
%
|
||
Administrative and headcount costs
|
1,939
|
|
|
8
|
%
|
|
1,861
|
|
|
5
|
%
|
||
Total Cangrelor
|
2,694
|
|
|
12
|
%
|
|
13,602
|
|
|
40
|
%
|
||
Oritavancin
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
205
|
|
|
1
|
%
|
|
6,615
|
|
|
19
|
%
|
||
Manufacturing development
|
2,002
|
|
|
9
|
%
|
|
1,146
|
|
|
3
|
%
|
||
Administrative and headcount costs
|
3,208
|
|
|
14
|
%
|
|
491
|
|
|
1
|
%
|
||
Total Oritavancin
|
5,415
|
|
|
24
|
%
|
|
8,252
|
|
|
23
|
%
|
||
MDCO-157
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
(124
|
)
|
|
(1
|
)%
|
|
526
|
|
|
2
|
%
|
||
Manufacturing development
|
(1
|
)
|
|
—
|
%
|
|
58
|
|
|
—
|
%
|
||
Administrative and headcount costs
|
273
|
|
|
1
|
%
|
|
425
|
|
|
1
|
%
|
||
Total MDCO-157
|
148
|
|
|
—
|
%
|
|
1,009
|
|
|
3
|
%
|
||
MDCO-2010
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
—
|
|
|
—
|
%
|
|
349
|
|
|
1
|
%
|
||
Manufacturing development
|
—
|
|
|
—
|
%
|
|
196
|
|
|
1
|
%
|
||
Administrative and headcount costs
|
—
|
|
|
—
|
%
|
|
446
|
|
|
1
|
%
|
||
Total MDCO-2010
|
—
|
|
|
—
|
%
|
|
991
|
|
|
3
|
%
|
||
MDCO-216
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
686
|
|
|
3
|
%
|
|
388
|
|
|
1
|
%
|
||
Manufacturing development
|
722
|
|
|
3
|
%
|
|
603
|
|
|
2
|
%
|
||
Administrative and headcount costs
|
951
|
|
|
4
|
%
|
|
354
|
|
|
1
|
%
|
||
Total MDCO-216
|
2,359
|
|
|
10
|
%
|
|
1,345
|
|
|
4
|
%
|
||
IONSYS
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
83
|
|
|
—
|
%
|
|
—
|
|
|
—
|
%
|
||
Manufacturing development
|
1,399
|
|
|
6
|
%
|
|
—
|
|
|
—
|
%
|
||
Administrative and headcount costs
|
2,143
|
|
|
9
|
%
|
|
—
|
|
|
—
|
%
|
||
Total IONSYS
|
3,625
|
|
|
15
|
%
|
|
—
|
|
|
—
|
%
|
||
Fibrocaps
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
2,373
|
|
|
10
|
%
|
|
—
|
|
|
—
|
%
|
||
Total Fibrocaps Program
|
2,373
|
|
|
10
|
%
|
|
—
|
|
|
—
|
%
|
||
Other
|
1,571
|
|
|
7
|
%
|
|
5,161
|
|
|
15
|
%
|
||
Total
|
$
|
23,187
|
|
|
100
|
%
|
|
$
|
34,536
|
|
|
100
|
%
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2013
|
|
% of
Total R&D
|
|
2012
|
|
% of
Total R&D
|
||||||
|
(In thousands)
|
|
|
|
(In thousands)
|
|
|
||||||
Angiomax
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
$
|
6,989
|
|
|
6
|
%
|
|
$
|
5,090
|
|
|
5
|
%
|
Manufacturing development
|
58
|
|
|
—
|
%
|
|
69
|
|
|
—
|
%
|
||
Administrative and headcount costs
|
6,357
|
|
|
6
|
%
|
|
1,984
|
|
|
2
|
%
|
||
Total Angiomax
|
13,404
|
|
|
12
|
%
|
|
7,143
|
|
|
7
|
%
|
||
Cleviprex
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
|
|
—
|
%
|
|
163
|
|
|
—
|
%
|
|||
Manufacturing development
|
311
|
|
|
1
|
%
|
|
781
|
|
|
1
|
%
|
||
Administrative and headcount costs
|
1,917
|
|
|
2
|
%
|
|
1,274
|
|
|
1
|
%
|
||
Total Cleviprex
|
2,228
|
|
|
3
|
%
|
|
2,218
|
|
|
2
|
%
|
||
Cangrelor
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
2,255
|
|
|
2
|
%
|
|
34,767
|
|
|
35
|
%
|
||
Manufacturing development
|
2,545
|
|
|
2
|
%
|
|
1,233
|
|
|
1
|
%
|
||
Administrative and headcount costs
|
9,798
|
|
|
10
|
%
|
|
4,863
|
|
|
5
|
%
|
||
Total Cangrelor
|
14,598
|
|
|
14
|
%
|
|
40,863
|
|
|
41
|
%
|
||
Oritavancin
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
9,679
|
|
|
9
|
%
|
|
22,093
|
|
|
22
|
%
|
||
Manufacturing development
|
6,108
|
|
|
6
|
%
|
|
3,539
|
|
|
3
|
%
|
||
Administrative and headcount costs
|
8,794
|
|
|
8
|
%
|
|
2,448
|
|
|
2
|
%
|
||
Total Oritavancin
|
24,581
|
|
|
23
|
%
|
|
28,080
|
|
|
27
|
%
|
||
MDCO-157
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
282
|
|
|
—
|
%
|
|
626
|
|
|
1
|
%
|
||
Manufacturing development
|
247
|
|
|
—
|
%
|
|
471
|
|
|
—
|
%
|
||
Administrative and headcount costs
|
919
|
|
|
1
|
%
|
|
1,658
|
|
|
2
|
%
|
||
Total MDCO-157
|
1,448
|
|
|
1
|
%
|
|
2,755
|
|
|
3
|
%
|
||
MDCO-2010
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
48
|
|
|
—
|
%
|
|
767
|
|
|
1
|
%
|
||
Manufacturing development
|
(1
|
)
|
|
—
|
%
|
|
822
|
|
|
1
|
%
|
||
Administrative and headcount costs
|
190
|
|
|
—
|
%
|
|
1,865
|
|
|
2
|
%
|
||
Total MDCO-2010
|
237
|
|
|
—
|
%
|
|
3,454
|
|
|
4
|
%
|
||
MDCO-216
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
1,284
|
|
|
1
|
%
|
|
786
|
|
|
1
|
%
|
||
Manufacturing development
|
2,029
|
|
|
2
|
%
|
|
1,684
|
|
|
2
|
%
|
||
Administrative and headcount costs
|
2,898
|
|
|
3
|
%
|
|
1,005
|
|
|
1
|
%
|
||
Total MDCO-216
|
6,211
|
|
|
6
|
%
|
|
3,475
|
|
|
4
|
%
|
||
IONSYS
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
947
|
|
|
|
|
|
|
|
|||||
Manufacturing development
|
4,728
|
|
|
4
|
%
|
|
—
|
|
|
—
|
%
|
||
Administrative and headcount costs
|
6,605
|
|
|
6
|
%
|
|
—
|
|
|
—
|
%
|
||
Total IONSYS
|
12,280
|
|
|
10
|
%
|
|
—
|
|
|
—
|
%
|
||
FIBROCAPS
|
|
|
|
|
|
|
|
||||||
Clinical trials
|
2,373
|
|
|
2
|
%
|
|
—
|
|
|
—
|
%
|
||
Total Fibrocaps
|
2,373
|
|
|
2
|
%
|
|
—
|
|
|
—
|
%
|
ALN-PCS Program
|
|
|
|
|
|
|
|
||||||
Administrative and headcount costs
|
25,000
|
|
|
23
|
%
|
|
|
|
—
|
%
|
|||
Total ALN-PCS Program
|
25,000
|
|
|
23
|
%
|
|
|
|
—
|
%
|
|||
Other
|
6,048
|
|
|
6
|
%
|
|
12,288
|
|
|
12
|
%
|
||
Total
|
$
|
108,408
|
|
|
100
|
%
|
|
$
|
100,276
|
|
|
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,
|
||||||||||||||||||||||||||
|
2013
|
|
2012
|
|
Change $
|
|
Change %
|
|
2013
|
|
2012
|
|
Change $
|
|
Change %
|
||||||||||||||
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||||||||||||
Selling, general and administrative expenses
|
$
|
62,528
|
|
|
$
|
43,396
|
|
|
$
|
19,132
|
|
|
44.1
|
%
|
|
$
|
178,954
|
|
|
$
|
127,049
|
|
|
$
|
51,905
|
|
|
40.9
|
%
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||||||||||||||||
|
2013
|
|
2012
|
|
Change $
|
|
Change %
|
|
2013
|
|
2012
|
|
Change $
|
|
Change %
|
||||||||||||||
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||||||||||||
Co-promotion income
|
$
|
4,423
|
|
|
$
|
3,750
|
|
|
$
|
673
|
|
|
17.9
|
%
|
|
$
|
12,241
|
|
|
$
|
6,250
|
|
|
$
|
5,991
|
|
|
95.9
|
%
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||||||||||||||||
|
2013
|
|
2012
|
|
Change $
|
|
Change %
|
|
2013
|
|
2012
|
|
Change $
|
|
Change %
|
||||||||||||||
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||||||||||||
Interest expense
|
$
|
(3,765
|
)
|
|
$
|
(3,605
|
)
|
|
$
|
(160
|
)
|
|
4.4
|
%
|
|
$
|
(11,143
|
)
|
|
$
|
(4,389
|
)
|
|
$
|
(6,754
|
)
|
|
153.9
|
%
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||||||||||||||||
|
2013
|
|
2012
|
|
Change $
|
|
Change %
|
|
2013
|
|
2012
|
|
Change $
|
|
Change %
|
||||||||||||||
|
(in thousands)
|
|
|
|
(in thousands)
|
|
|
||||||||||||||||||||||
Other income
|
$
|
383
|
|
|
$
|
204
|
|
|
$
|
179
|
|
|
87.7
|
%
|
|
$
|
1,186
|
|
|
$
|
963
|
|
|
$
|
223
|
|
|
23.2
|
%
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|||||||||||||||||||||||||
|
2013
|
|
2012
|
|
Change $
|
|
Change %
|
|
2013
|
|
2012
|
|
Change $
|
|
Change %
|
|||||||||||||
|
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
(Provision) for income tax
|
$
|
(16,068
|
)
|
|
$
|
(6,172
|
)
|
|
$
|
(9,896
|
)
|
|
*
|
|
$
|
(17,163
|
)
|
|
$
|
(18,897
|
)
|
|
$
|
1,734
|
|
|
(9.2
|
)%
|
•
|
the extent to which Angiomax is commercially successful globally;
|
•
|
our ability to maintain market exclusivity for Angiomax in the United States through the enforcement of the '727 patent and the '343 patent during the period following the expiration of the patent term of the '404 patent on December 15, 2014 and the six month pediatric exclusivity on June 15, 2015 through at least May 1, 2019, the date on which we agreed APP may sell a generic version of Angiomax;
|
•
|
the extent to which Recothrom, Cleviprex, ready-to-use Argatroban and the acute care generic products for which we acquired the non-exclusive right to sell and distribute from APP are commercially successful in the United States;
|
•
|
the extent to which our global collaboration with AstraZeneca, including our four-year co-promotion arrangement for BRILINTA in the United States, is successful;
|
•
|
the extent to which we are successful in our efforts to establish a commercial infrastructure outside the United States;
|
•
|
the consideration paid by us and to be 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 and our products in development;
|
•
|
the cost and outcomes of regulatory submissions and reviews for approval of Angiomax in additional countries and for additional indications, of Recothrom and Cleviprex outside the United States and of our other products in development globally, including the recently acquired Fibrocaps;
|
•
|
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.
|
•
|
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 the enforcement of the '727 patent and the '343 patent during the period following the expiration of the patent term of the '404 patent on December 15, 2014 and the six month pediatric exclusivity on June 15, 2015 through at least May 1, 2019, the date on which we agreed APP may sell a generic version of 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 the enforcement of the '727 patent and the '343 patent during the period following the expiration of the patent term of the '404 patent on December 15, 2014 and the six month pediatric exclusivity on June 15, 2015 through at least May 1, 2019, the date on which we agreed APP may sell a generic version of Angiomax;
|
•
|
the extent to which Recothrom, Cleviprex, ready-to-use Argatroban and the acute care generic products that we acquired the non-exclusive right to sell and distribute from APP are commercially successful in the United States;
|
•
|
the extent to which our global collaboration with AstraZeneca, including our four-year co-promotion arrangement for BRILINTA in the United States, is successful;
|
•
|
the extent to which we are successful in our efforts to establish a commercial infrastructure outside the United States;
|
•
|
the consideration paid by us and to be 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 and our products in development;
|
•
|
the cost and outcomes of regulatory submissions and reviews for approval of Angiomax in additional countries and for additional indications, of Recothrom and Cleviprex outside the United States and of our other products in development globally, including the recently acquired Fibrocaps;
|
•
|
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.
|
•
|
difficulty in integrating the operations, products or product candidates and personnel of an acquired company;
|
•
|
entry into markets in which we have no or limited direct prior experience and where competitors in such markets have stronger market positions;
|
•
|
failure to successfully further develop the acquired or licensed business, product, compounds, programs or technology or to achieve strategic objectives, including commercializing and marketing successfully the development stage compounds and clinical stage candidates that we acquire or license;
|
•
|
disruption of our ongoing business and distraction of our management and employees from other opportunities and challenges;
|
•
|
inadequate or unfavorable clinical trial results from acquired or contracted for product candidates;
|
•
|
inability to retain personnel, key customers, distributors, vendors and other business partners of the acquired company, or acquired or licensed product or technology;
|
•
|
potential failure of the due diligence processes to identify significant problems, liabilities or other shortcomings or challenges of an acquired company, or acquired or licensed product or technology, including but not limited to, problems, liabilities or other shortcomings or challenges with respect to intellectual property, product quality, revenue recognition or other accounting practices, employee, customer or partner disputes or issues and other legal and financial contingencies and known and unknown liabilities;
|
•
|
liability for activities of the acquired company or licensor before the acquisition or license, including intellectual property infringement claims, violations of laws, commercial disputes, tax liabilities, and other known and unknown liabilities;
|
•
|
exposure to litigation or other claims in connection with, or inheritance of claims or litigation risk as a result of, an acquisition or license, including but not limited to, claims from terminated employees, customers, former stockholders or other third-parties; and
|
•
|
difficulties in the integration of the acquired company's departments, systems, including accounting, human resource and other administrative systems, technologies, books and records, and procedures, as well as in maintaining uniform standards, controls, including internal control over financial reporting required by the Sarbanes−Oxley Act of 2002 and related procedures and policies.
|
•
|
impacting our ability to satisfy our obligations;
|
•
|
increasing our vulnerability to general adverse economic and industry conditions;
|
•
|
limiting our ability to obtain additional financing in the future;
|
•
|
increasing the portion of our cash flows that may have to be dedicated to interest and principal payments and may not be available for operations, research and development, working capital, capital expenditures, expansion, acquisitions or general corporate or other purposes;
|
•
|
limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; and
|
•
|
placing us at a possible competitive disadvantage to less leveraged competitors and competitors that have better access to capital resources.
|
•
|
the GELFOAM Plus hemostasis kit marketed by Baxter Healthcare Corporation;
|
•
|
mechanical hemostats, such as absorbable gelatin sponges;
|
•
|
collagen, cellulose, or polysaccharide-based hemostats applied as sponges, fleeces, bandages, or microspheres which do not contain thrombin or any other active biologic compounds;
|
•
|
active hemostats, which are thrombin products that may be derived from bovine or human pooled plasma purification or human recombinant manufacturing processes;
|
•
|
flowable hemostats, which consists of granular collagen or gelatin component that is mixed with saline or reconstituted thrombin to form a semi-solid, flowable putty; and
|
•
|
fibrin sealants, which consists of thrombin and fibrinogen that can be sprayed or applied directly to the bleeding surface.
|
•
|
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 or supply 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, ethics committees 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, NDAs or BLAs 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 the enforcement of the '727 patent and the '343 patent during the period following the expiration of the patent term of the '404 patent on December 15, 2014 and the six month pediatric exclusivity on June 15, 2015 through at least May 1, 2019, the date on which we agreed APP may sell a generic version of 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 5, 2013
|
|
By:
|
/s/ Glenn P. Sblendorio
|
|
|
|
|
Glenn P. Sblendorio
|
|
|
|
|
President and Chief Financial
|
|
|
|
|
Officer (Principal Financial and Accounting Officer)
|
Exhibit Number
|
|
Description
|
|
|
|
10.1*
|
|
Patent Licensing Agreement, dated October 25, 2004, by and between Quadrant Drug Delivery Limited and ProFibrix B.V., as amended by Amendment Deed No. 1, dated February 14, 2007, Amendment Deed No. 2, dated June 12, 2007, and Amendment Deed No. 3, dated July 2, 2012
|
|
|
|
10.2*
|
|
Fourth Amendment to Second Amended and Restated Distribution Agreement, dated April 29, 2013, by and between registrant and Integrated Commercialization Solutions, Inc.
|
|
|
|
10.3
|
|
Fifth Amendment to Second Amended and Restated Distribution Agreement, dated September 12, 2013, by and between registrant and Integrated Commercialization 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, 2013, formatted in XBRL (Extensible Business Reporting Language): (i) the Consolidated Balance Sheet, (ii) the Consolidated Statement of Income, (iii) the Consolidated Statement of Cash Flow, and (iv) Notes to Consolidated Financial Statements.
|
*
|
Confidential treatment requested as to certain portions, which portions have been omitted and filed separately with the Securities and Exchange Commission.
|
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Double asterisks denote omissions.
|
Fibrocaps Patent Licensing Agreement
|
(1)
|
Quadrant Drug Delivery Limited
a company incorporated under the laws of England with company registration number 2704727 and whose registered office is at 1 Mere Way, Ruddington, Nottingham, NG11 6JS, England (“Quadrant”); and
|
(2)
|
Profibrix B.V.
a company registered in The Netherlands whose statutory seat is at Acacialaan 7, 2351 CA, Leiderdorp, The Netherlands (“Profibrix”).
|
(A)
|
Quadrant is the owner of the patents and patent applications set out in Schedules 1 and 2 of this Agreement.
|
(B)
|
Quadrant is willing to grant to Profibrix and Profibrix wishes to receive exclusive and non-exclusive worldwide licences under the patents and patent applications set out in Schedule 1 of this Agreement in accordance with and subject to the provisions of this Agreement.
|
(C)
|
Quadrant is willing to grant to Profibrix and Profibrix wishes to receive a non-exclusive, worldwide licence under the patents set out in Schedule 2 in accordance with and subject to the provisions set out in this Agreement.
|
1.
|
DEFINITIONS
|
1.1
“Associate”
|
means in relation to a party, any body-corporate or other legal entity which:-
(a) is directly or indirectly owned and/or controlled by that party;
(b) that directly or indirectly owns and/or controls that party; or
(c) is directly or indirectly owned and/or controlled by the legal entity referred to in (b) above.
In the case of legal entities having stocks and/or shares, ownership or control shall exist through the direct or indirect ownership and/or control of more than fifty percent of the voting shares. In the case of any other legal entity, ownership and/or control shall exist through the ability to directly or indirectly control the management and/or business of the legal entity;
|
|
1.2
“Anniversary Date”
|
the first anniversary of the Closing Date;
|
1.3
“API”
|
any compound which is intended or represented to have a diagnostic or prophylactic or therapeutic effect. For the avoidance of doubt API shall include Factor VIII and botulinum toxin, and shall include substances manufactured by processes such as chemical synthesis; fermentation; recombinant DNA or other biotechnology methods; isolation/recovery from natural sources; or any combination of these processes;
|
|
1.4
“Authorised Development Costs”
|
the costs and expenses incurred by Profibrix in the development of the Fibrocaps Products provided that such costs and expenses are either-
(i) specified in the Development Plan; or
(ii) incurred with the prior written consent of Quadrant;
|
|
1.5
“BioPartner”
|
BioPartner Start-up Ventures C.V., a partnership (“
commanditaire vennootschap
”) incorporated under the laws of The Netherlands with registered office at (1098 SM) Amsterdam at the Kruislaan 406;
|
|
1.6
“Closing Date”
|
the date upon which the Condition Precedent is fulfilled;
|
|
1.7
“Condition Precedent”
|
the condition precedent set out in Clause 2.1;
|
|
1.8
“Development Plan”
|
the development plan set out in Schedule 4 as amended from time to time with the agreement of both parties;
|
|
1.9
“Excluded Field”
|
shall mean any pharmaceutical preparation which:-
[**];
|
|
1.10
“Fibrocaps Field”
|
a pharmaceutical formulation that does not fall within the Excluded Field comprising spray dried human fibrinogen or variants thereof and/or thrombin, but excluding any other APIs, for administration to humans for the sole purpose of controlling or preventing bleeding;
|
1.11
“Fibrocaps Granted Patents”
|
means:-
(a) the patents listed in Schedule 1;
(b) any patents granted in respect of the Fibrocaps Patent Applications; and
(c) any re-issue, re-examination or renewals thereof and any extensions of the exclusivity granted in connection with the patents referred to in (a) and/or (c) above, including extensions granted under the US Drug Price Competition and Patent Term Restoration Act 1984 and the EC Supplementary Protection Certificate Regulation (Council Regulation (EEC) No. 1768/92) and any legislation, amending, replacing or implementing the foregoing;
|
|
1.12
“Fibrocaps Patent Applications”
|
patent applications listed in Schedule 1 including any continuation applications, divisional applications or continuation-in-part applications relating to such patent applications and any national or international patent applications claiming priority from such patent applications anywhere in the world;
|
1.13
“Fibrocaps Patents”
|
means:-
(a) the patents listed in Schedule 1;
(b) the patent applications listed in Schedule 1 including any continuation applications, divisional applications or continuation-in-part applications relating to such patent applications and any national or international patent applications claiming priority from such patent applications anywhere in the world;
(c) the patents granted in respect of the patent applications referred to in (b) above;and
any re-issue, re-examination or renewals thereof and any extensions of the exclusivity granted in connection with the patents referred to in (a) and/or (c) above, including extensions granted under the US Drug Price Competition and Patent Term Restoration Act 1984 and the EC Supplementary Protection Certificate Regulation (Council Regulation (EEC) No. 1768/92) and any legislation, amending, replacing or implementing the foregoing;
|
|
1.14
“Fibrocaps Product”
|
any product, including any pharmaceutical formulation comprising spray dried fibrinogen and/or thrombin microcapsules or any variant thereof, whose development, manufacture, import, marketing, use, site or supply falls within the scope of one or more of the Fibrocaps Patents;
|
1.15
“Granted Patents”
|
means:-
(a) the patents listed in Schedules 1and 2;
(b) any patents granted in respect of the Patent Applications; and
(c) any re-issue, re-examination or renewals thereof and any extensions of the exclusivity granted in connection with the patents referred to in (a) and/or (c) above, including extensions granted under the US Drug Price Competition and Patent Term Restoration Act 1984 and the LC Supplementary Protection Certificate Regulation (Council Regulation (EEC) No. 1768/92) and any legislation, amending, replacing or implementing the foregoing;
|
|
1.16
“Intellectual Property Rights”
|
patents, any extensions of the exclusivity granted in connection with patents, registered designs, applications for any of the foregoing (including, continuations, continuations-in-part and divisional applications), the right to apply for any of the foregoing, copyrights, design rights, rights, moral rights, database rights, publication rights, rights in know-how, trade secrets and confidential information and all other forms of intellectual property which may exist anywhere in the world;
|
|
1.17
“Licences”
|
the licences granted to Profibrix under Clause 3.1 and 3.2 and 3.3;
|
1.18
“Licensed Patents”
|
means:-
(a) the patents listed in Schedule 2;
(b) the patent application listed in Schedule 2 including any continuation applications, divisional applications or continuation-in-part applications relating to such patent applications and any national or international patent applications claiming priority from such patent applications anywhere in the world;
(c) the patents granted in respect of the patent applications referred to in (b) above; and
(d) any re-issue, re-examination or renewals thereof and any extensions of the exclusivity granted in connection with the patents referred to in (a) and/or (c) above, including extensions granted under the US Drug Price Competition and Patent Term Restoration Act 1984 and the EC Supplementary Protection Certificate Regulation (Council Regulation (EEC) No. 1768/92) and any legislation, amending, replacing or implementing the foregoing;
|
|
1.19
“Licensed Product”
|
means any product whose development, manufacture, import, marketing, use, sale or supply falls within the scope of one or more of the Licensed Patents;
|
|
1.20
‘‘Licensing Revenues”
|
any sums or other consideration received by Profibrix and/or its Associates in respect of the licensing of the Patents including sums received under any Profibrix Licence Agreement but excluding any sums received by Quadrant pursuant to Clauses 3.2 and 3.3;
|
|
1.21
“Marketing Partners”
|
any third party appointed by Profibrix and/or its Associates to make sales of Fibrocaps Products;
|
1.22
“Net Sales Value”
|
the amount billed or invoiced by Profibrix, its Associates and/or Profibrix Licensees to third parties in respect of supplies of the Products less the following items as indicated on the relevant invoice and appropriate documents: sales taxes, costs of delivery, trade discounts actually granted, amounts actually repaid or credited for defective or returned Products;
|
|
1.23
‘Patent Applications”
|
patent applications listed in Schedules 1 and 2 including any continuation applications, divisional applications or continuation-in-part applications relating to such patent applications and any national or international patent applications claiming priority from such patent applications anywhere in the world:
|
|
1.24
“Patents”
|
the Granted Patents and the Patent Applications;
|
|
1.25
“Personnel”
|
officers, employees, consultants, agents, representatives, contractors and advisers:
|
|
1.26
“Products”
|
the Fibrocaps Products and/or the Licensed Products;
|
|
1.27
“Profibrix Licence Agreement”
|
any Sub-licence Agreement and any licence granted by Profibrix to a Profibrix Licensee under the Fibrocaps Patents and/or under a Licensed Patent in the Fibrocaps Field:
|
|
1.28
“Profibrix Licensee”
|
means:-
(a) a Sub-licensee;
(b) a Marketing Partner; and
(c) any third party (including an Associate of Profibrix) to whom Profibrix has directly or indirectly licensed, sub-licensed, contracted or otherwise transferred any of Profibrix’s rights and/or obligations under the Fibrocaps Patents;
|
|
1.29
“Quarter
|
the quarterly periods ending 31 March, 30 June, 30 September and 31 December;
|
|
1.30
“Signature Date”
|
the date of this Agreement as written above;
|
|
1.31
“Sub-licence Agreement”
|
any agreement between Profibrix and a Sub-licensee relating to the Licences;
|
2.
|
CONDITION PRECEDENT
|
2.1
|
The provisions of this Clause 2 shall take effect on the Signature Date. The provisions of Clauses 3-13 of this Agreement shall not take effect until the date on which BioPartner has paid to Profibrix at least €225,000.00 (two hundred and twenty-five thousand Euros) in respect of the issue to BioPartner of 444 (four hundred and forty-four) ordinary shares in Profibrix with a nominal value of €10.00 (ten Euros) each on terms and conditions that are no more favourable to BioPartner than the terms and conditions set out in the Subscription Agreement.
|
2.2
|
Profibrix shall promptly notify Quadrant once the Condition Precedent has been fulfilled and at the same time provide Quadrant with a true copy of all terms and conditions applicable to the issue to BioPartner of the shares in Profibrix in relation to the fulfilment of the Condition Precedent.
|
2.3
|
If the Condition Precedent set out in Clause 2.1 has not been fulfilled by 1
st
January 2005 then this Agreement shall terminate automatically and neither party shall have any further rights or obligations under this Agreement.
|
2.4
|
Quadrant shall inform Profibrix of the costs and expenses incurred by Quadrant and its Associates in negotiating the provisions of this Agreement, the Research Agreement and the Subscription Agreement and in carrying out due diligence on Profibrix. Within 14 days of Quadrant having informed Profibrix of its costs and expenses, Profibrix shall pay to Quadrant (1) the amount of such costs and expenses plus VAT up to a maximum of €15,000.00 (Fifteen thousand Euros) and (2) the costs of executing any of the notorial deeds required to implement the arrangements between the parties.
|
3.
|
LICENCES
|
3.1
|
Quadrant grants to Profibrix a non-transferable, worldwide, exclusive licence under the Fibrocaps Patents to develop, use, manufacture and sell products within the fibrocaps Field.
|
3.2
|
Quadrant grants to Profibrix a non-transferrable, worldwide, non-exclusive licence under the Fibrocaps Patents to develop, use, manufacture and sell products outside the Fibrocaps Field.
|
3.3
|
Quadrant grants to Profibrix a non-transferrable, worldwide, non-exclusive licence under the Licensed Patents to develop, use, manufacture and sell products within the Fibrocaps Field.
|
3.4
|
Profibrix shall not use and/or exploit the Fibrocaps Patents or Licensed Patents except as expressly authorised under the Licences.
|
3.5
|
Profibrix shall have the right to grant sub-licences under the Licence provided that Profibrix enters into a written agreement with each Sub-licensee and ensures that:-
|
3.5.1
|
the provisions of the Sub-licence Agreement are entirely consistent with the provisions of this Agreement;
|
3.5.2
|
the Sub-licence Agreement shall terminate automatically if this Agreement expires or is terminated;
|
3.5.3
|
each Sub-licensee complies fully at all times with the provisions of its Sublicence Agreement;
|
3.5.4
|
the Sub-licensee is not entitled to and does not grant further sub-licences in respect of the Licensed Patents without the prior written consent of Quadrant.
|
3.6
|
Profibrix shall be responsible to Quadrant for all acts and/or omissions of each Sublicensee as if such acts or omissions had been made by Profibrix.
|
3.7
|
Prolibrix shall not enter into any Sub-licence Agreement, waive or otherwise agree not to assert the Patents without obtaining Quadrant’s prior written approval of the Sub-licence Agreement, waiver or non-assertion agreement.
|
4.
|
PAYMENTS
|
4.1
|
In part consideration for the grant of the Licences, Profibrix shall, in accordance with the provisions of the Subscription Agreement, issue to Quadrant [**] ordinary shares in Profibrix each share having a nominal value of € 10 (ten Euros).
|
4.2
|
In part consideration for the grant of the Licences , Profibrix shall pay to Quadrant a royalty of [**]% of the Net Sales Value of Fibrocaps Products manufactured and/or supplied by Profibrix, its Associates and/or Profibrix Licensees.
|
4.3
|
In part consideration for the grant of the Licences Profibrix shall pay to Quadrant a royalty of [**]% of the Net Sales Value of Licensed Products manufactured and/or supplied by Profibrix, its Associates and/or Profibrix Licensees provided that Profibrix shall not be required to pay a royalty under this Clause 4.3 in respect of a unit of Licensed Product if Profibrix is required to pay a royalty under Clauses 4.2 in respect of that unit of Licensed Product.
|
4.4
|
If Profibrix, its Associates and/or Profibrix Licensees supply any Products other than on normal arm’s-length commercial terms exclusively for money, the Net Sales Value of the Product supplied shall for the purposes of this Agreement be deemed to be whichever is the higher of the Fair Market Value of the Product or the actual price at which Profibrix, its Associates or Profibrix Licensees supplied the Product.
|
4.5
|
If Profibrix, its Associates and/or Profibrix Licensees supply any Products as part of a package of products or services then the Net Sales Value of the Products shall for the purposes of this Agreement be deemed to be the proportion of the package price fairly attributed to the Product concerned in the relevant invoice to the customer.
|
4.6
|
For the purpose of Clause 4.4 “Fair Market Value” shall mean the value of the Product sold to similar customers in countries with similar pricing and reimbursement structures and for similar quantities. Any dispute as to the determination of a Fair Market Value that cannot be resolved through discussion between the parties shall be referred to an expert for resolution in accordance with the provisions of Schedule 6.
|
4.7
|
In part consideration for the grant of the Licences, Profibrix shall pay to Quadrant [**]% of any Licensing Revenues received by Profibrix and/or its Associates under any Profibrix Licence Agreement executed by Profibrix on or before the Anniversary Date.
|
4.8
|
In part consideration for the grant of the Licences, with respect to Profibrix Licence Agreements executed by Profibrix after the Anniversary Date, Profibrix shall pay to Quadrant [**]% of the difference between (1) the Licensing Revenue received by Profibrix and/or its Associates under such Profibrix Licence Agreement and (2) any Authorised Development Costs that have not previously been deducted from Licensing Revenue pursuant to this Clause 4.8.
|
4.9
|
For the avoidance of doubt, Quadrant shall not be required to refund any royalties or Licensing Revenues paid under this Agreement including as a consequence of:-
|
4.9.1
|
a Patent Application being wholly or partly amended, refused, rejected or otherwise ceasing to continue; and/or
|
4.9.2
|
a Granted Patent being wholly or partly amended, revoked, nullified otherwise ceasing to continue in force.
|
5.
|
PAYMENT TERMS
|
5.1
|
Within 30 days of the end of each Quarter, Profibrix shall provide Quadrant with a royalty and revenue statement for that Quarter setting out the information listed in Schedule 5.
|
5.2
|
Profibrix shall pay the sums due to Quadrant under Clauses 4.2 and 4.3 in respect of supplies of Products made during any Quarter within 30 days of the end of such Quarter.
|
5.3
|
Profibrix shall pay sums due to Quadrant under Clauses 4.7 and 4.8 in respect of Licensing Revenue received by Profibrix and/or its Associates during any Quarter within 30 days of the end of such Quarter.
|
5.4
|
All sums payable under this Agreement:-
|
5.4.1
|
are exclusive of any value added tax or any other sales lax or duties, which where applicable, shall be payable by Profibrix in addition;
|
5.4.2
|
shall be paid in euros (or its successor) by direct transfer to the credit of Quadrant’s bank account, details of which shall be notified to Profibrix as and when necessary;
|
5.4.3
|
shall be paid in full by the due date for payment as specified in this Agreement. If Profibrix fails to pay any sum due under this Agreement in full by the due date for payment then Quadrant may, without prejudice to any other right or remedy available to Quadrant, charge interest on any outstanding amount on a daily basis at a rate equivalent to the Euribor Offered Rate (6 months) then in force plus 2%;
|
5.4.4
|
shall be paid in full without any deductions (including deductions in respect of items such as income, corporation or other taxes, charges and/or duties) except insofar as Profibrix is required by law to deduct withholding tax from sums payable to Quadrant. If Profibrix is required by law to deduct withholding tax then Profibrix shall:-
|
5.4.4.1
|
ensure that the deduction or withholding does not exceed the minimum amount required to comply with relevant tax law requirements;
|
5.4.4.2
|
account to the relevant taxation or other authorities with the full amount of the deduction or withholding within the period for payment permitted by the applicable law;
|
5.4.4.3
|
provide to Quadrant within the period for payment permitted by the relevant law either an official receipt of the relevant taxation authorities involved in respect of all amounts so deducted or withheld or if such receipts are not issued by the taxation authorities concerned certificate of deduction or equivalent evidence of the relevant deduction or withholding; and
|
5.4.4.4
|
co-operate with Quadrant to ensure that the amount of any deductions or withholdings required by law are kept to a minimum and that Quadrant obtains a tax credit in respect of the amount withheld.
|
5.4.5
|
If Products are sold or supplied by Profibrix, its Associates and/or Profibrix Licensees in a currency other than Euros (or its successor), the royalties payable in respect of such sales under this Agreement shall be first determined in the currency of invoice and then converted into Euros (or its successor) at the open middle market spot rate of exchange in London as published in the Financial Times on the last day of the Quarter in which such sales took place or the Licensing Revenue was received by Profibrix.
|
6.
|
RECORDS AND AUDITS
|
6.1
|
During the term of this Agreement and for a period of 3 years thereafter, Profibrix shall and shall procure that its Associates, and Profibrix Licensees shall, keep at their normal place of business detailed, accurate and up-to-date records and books of account showing the quantity, description and value of all Products supplied by Profibrix, its Associates and Profibrix Licensees in each country in each case during the previous 3 years. Profibrix shall ensure that such records and books and account are sufficient to ascertain the royalties and share of Licensing Revenue payable to Quadrant under this Agreement.
|
6.2
|
Profibrix shall, and shall procure that its Associates and Profibrix Licensees shall, make their records and books available for inspection during normal business hours by an independent professional accountant appointed by Quadrant for the purpose of verifying the accuracy of any statement provided by Profibrix to Quadrant pursuant to Clause 6.1.
|
6.3
|
Quadrant shall be entitled to have inspections carried out pursuant to Clause 6.2 once every calendar year (and once following termination or expiry of this Agreement) on giving Profibrix, its Associates and/or Profibrix Licensees 2 weeks written notice prior to each inspection.
|
6.4
|
Quadrant shall bear the cost of carrying out the inspections referred to in Clause 6.2 unless there is an error of more than 5% in any royalty and Licensing Revenue statement provided by Profibrix, in which case Profibrix shall immediately pay to Quadrant the costs of making the relevant inspection. If Quadrant’s inspection shows that Profibrix has paid more than the amounts properly due under this Agreement then Profibrix shall be entitled to deduct such excess from the sums payable to Quadrant under this Agreement. If Quadrant’s inspection reveals a deficit then, without prejudice to any other right or remedy available to Quadrant, Profibrix shall promptly make good the deficit and pay interest on the deficit at the Euribot Offered Rate (6 months plus 2% from the date upon which the deficit arose to the date upon which the deficit was paid.
|
7.
|
DEVELOPMENT OF FIBROCAPS PRODUCTS
|
8.
|
FILING, PROSECUTION AND MAINTENANCE
|
8.1
|
Quadrant shall use reasonable efforts at Profibrix’s cost and expense to procure the grant of the Fibrocaps Patent Applications. Quadrant shall take account of Profibrix’s views concerning the prosecution strategy for the Fibrocaps Patent Applications.
|
8.2
|
Quadrant shall, at Profibrix’s expense, use reasonable efforts to maintain the Fibrocaps Granted Patents.
|
8.3
|
At least 90 days before allowing any Fibrocaps Patent to lapse or abandoning any application for a Fibrocaps Patent, Quadrant shall notify Profibrix of the identity of the Fibrocaps Patent concerned and its intention to allow it to lapse or to abandon it. At the request of Profibrix, Quadrant shall promptly assign to Profibrix, free of charge, the Fibrocaps Patent concerned and the parties shall execute an assignment in the form set out in Schedule 3.
|
8.4
|
Subject to Clause 8.6, Profibrix shall not assign, or agree to assign, grant an option to assign, or otherwise encumber all or any of the Fibrocaps Patents assigned to Profibrix under Clause 8.3 on or before the Anniversary Date.
|
8.5
|
Profibrix shall not assign or otherwise transfer all or any of the Fibrocaps Patent assigned to Profibrix under Clause 8.3 unless the proposed assignee has entered into a legally binding written agreement with Quadrant on terms reasonably required by Quadrant to ensure (1) Quadrant continues to receive payments that are the same as those that would have been payable under this Agreement; and (2) such assignment does not affect Quadrant’s ability to exercise any of the rights granted to Quadrant under this Agreement.
|
8.6
|
Profibrix shall not grant any right, licence, waiver or otherwise agree not to assert any or all of the Fibrocaps Patents assigned to Profibrix under Clause 8.3 without the prior written approval by Quadrant of the terms of the relevant agreement.
|
8.7
|
For the avoidance of doubt, Quadrant shall not be under any obligation to file, prosecute, maintain, defend and/ or enforce the Licensed Patents.
|
8.8
|
If Quadrant finds that any of the Fibrocaps Patents are being infringed by a third party then Quadrant will notify Profibrix of such infringement. If Profibrix informs Quadrant that it does not intend to take action against the infringer or Profibrix fails to take action against the infringer within 90 days of the date of Quadrant’s notice to Profibrix then Quadrant shall be entitled to take action against the infringer in Profibrix’s name at Quadrant’s own cost and expense. Any award of damages or costs arising out of such action taken by Quadrant shall belong to Quadrant.
|
9.
|
WARRANTIES
|
9.1
|
Quadrant warrants to Profibrix that at the Signature Date:-
|
9.1.1
|
Quadrant is the sole legal and beneficial owner of the Fibrocaps Patents;
|
9.1.2
|
Quadrant has not granted any rights under the Fibrocaps Patents to third parties in the Fibrocaps Field and has not granted any exclusive right outside of the Fibrocaps Field;
|
9.1.3
|
Quadrant is the owner of the Licensed Patents and has the right to grant the Licences;
|
9.1.4
|
the Granted Patents are subsisting and all payments due to patent offices in respect of the maintenance of the Granted Patents prior to the Signature Date have been paid;
|
9.1.5
|
to the best of Quadrant’s knowledge Quadrant has not received notice that interference and/or opposition proceedings have been initiated against any of the Fibrocaps Patents.
|
9.1.6
|
Quadrant has not received notice that interference and/or opposition proceedings have been initiated against any of the Fibrocaps Patents.
|
9.2
|
All statements and representations (other than fraudulent misrepresentations), warranties, terms and conditions (except for those set out in this Agreement) including any implied by statute, common law or otherwise are hereby excluded to the maximum extent permissible by law.
|
9.3
|
Without prejudice to the generality of Clause 9.2 and save for the warranties set out in Clause 9.1, Quadrant does not give any warranty, representation or undertaking:-
|
9.3.1
|
as to the efficacy, usefulness, safety or commercial or technical viability of the Technology and/or any products made or processes carried out using the Technology;
|
9.3.2
|
that any of the Granted Patents is or will be valid or that any of Patent Applications will results in the grant of a valid patent;
|
9.3.3
|
that the Technology can be freely exploited in all or any parts of the world;
|
9.3.4
|
that the Technology will not infringe the Intellectual Property Rights or other rights of any third party; and/or
|
9.3.5
|
that a Patent will be upheld or continue in force if that Patent is the subject of interference proceedings or other similar proceedings.
|
10.
|
LIMITATION OF LIABILITY AND INDEMNITY
|
10.1
|
Profibrix shall assume all risks associated with the development, manufacture, use and supply of the Products and shall be responsible for third party claims relating to the Products including claims based upon product liability laws and/or infringement of third party Intellectual Property Rights.
|
10.2
|
Subject to the provisions of Clauses 13.11, Quadrant, its Associates and their Personnel shall have no liability to Profibrix whether in contract, tort or common negligence or otherwise for any loss or damage arising out of or in connection with:-
|
10.2.1
|
the exercise by Profibrix of any of its rights under this Agreement or the Patents including any research, development, manufacture, use, distribution or supply of Products by Profibrix, its Associates and/or the Profibrix Licensees; and/or
|
10.2.2
|
any possession or use by a third party of Products manufactured and/or supplied by or on behalf of Profibrix, its Associates and/or the Profibrix Licensees.
|
10.3
|
Profibrix shall fully indemnify, and at all times keep Quadrant, its Associates and Personnel fully indemnified, against any and all liability, damages, claims, proceedings, expenses (including, legal expenses and expert’s fees) arising out of or in connection with:-
|
10.3.1
|
the activities of Profibrix, its Associates and/or the Profibrix Licensees pursuant to this Agreement and/or in relation to the Patents including any research, development, manufacture, use, distribution or supply of Products and/or
|
10.3.2
|
any possession or use by a third party of Products manufactured and/or supplied by or on behalf of Profibrix, its Associates, and/or the Profibrix Licensees.
|
10.4
|
Quadrant shall subject to Clause 10.7 fully indemnify, and at all times keep Profibrix, its Associates and Personnel fully indemnified, against any and all liability, damages, claims, proceedings, expenses (including, legal expenses and expert’s fees) arising out of or in connection with:-
|
10.4.1
|
any research, development, manufacture, use, distribution or supply of products by Quadrant, its Associates and/or its sub-licensees whose development, manufacture or supply falls within the scope of one or more of the fibrocaps Patents; and/or
|
10.4.2
|
any possession or use by a third party of products whose development, manufacture or supply falls within the scope of one or more of the fibrocaps Patents manufactured and/or supplied by or on behalf of Quadrant, its Associates, and/or its sub-licensees.
|
10.5
|
Subject to the provisions of Clause 13.11 the total liability of Quadrant for all claims arising out of or in connection with this Agreement (and any assignment pursuant thereto), the Research Agreement, the Synthocytes Patent Licensing Agreement (and any assignment pursuant thereto) and/or the Subscription Agreement, shall not exceed €100,000 (One Hundred Thousand Euros). The provisions of this Clause 10.5 shall not apply to claims arising out of Clause 10.4.
|
10.6
|
Except as provided in Clause 13.11, Quadrant shall not be liable for the following loss or damage however caused and even if foreseeable by Quadrant:-
|
10.6.1
|
economic loss, which shall include loss of profits, business, revenue, goodwill, or anticipated savings;
|
10.6.2
|
special, indirect or consequential loss;
|
10.6.3
|
loss arising from any claim made against Profibrix by any third party; or
|
10.6.4
|
loss or damage arising from Profibrix’s failure to fulfil its responsibilities for any matter under the control of Profibrix.
|
10.7
|
The indemnity set out in Clause 10.4 shall not apply to any liability, damages, claims, proceedings, expenses (including legal expenses and expert’s fees) arising out of or in connection with:-
|
10.7.1
|
any research, development, manufacture, use, distribution or supply of products by Quadrant and/or its Associates for or on behalf of Profibrix and/or its Associates; and/or
|
10.7.2
|
any possession or use by a third party of products manufactured and/or supplied by Quadrant and/or its Associates for or on behalf of Profibrix and/or its Associates.
|
11.
|
EXPIRY AND TERMINATION
|
11.1
|
Unless terminated earlier in accordance with the provisions of this Agreement, this Agreement shall expire when the last of the Patents ceases to be in force.
|
11.2
|
Either party may terminate this Agreement forthwith by giving immediate notice of termination to the other party if:-
|
11.2.1
|
the other party commits a material breach of this Agreement which is not capable of remedy; or
|
11.2.2
|
the other party commits a material breach of this Agreement which is capable of remedy and having been notified of such breach fails to remedy it within 60 days of notification.
|
11.3
|
For the purposes of Clause 11.2, a breach shall be deemed to be capable of remedy if:-
|
11.3.1
|
the party in breach can comply with the provision(s) that have been breached in all respects other than as to time of performance; and
|
11.3.2
|
the breach is not one of a persistent series of breaches by the party in breach.
|
11.4
|
Quadrant may terminate this Agreement forthwith by giving Profibrix immediate notice of termination if:-
|
11.4.1
|
Profibrix fails to pay in full any payments due under this Agreement or the Research Agreement within 60 days of receiving notice from Quadrant demanding such payment;
|
11.4.2
|
Profibrix, its Associates and/or the Profibrix Licensees dispute or directly or indirectly assist any third party to dispute, the ownership, validity and/or scope of any of the Licensed Patents.
|
11.5
|
Quadrant may terminate this Agreement forthwith by giving Profibrix immediate notice of termination if:-
|
11.5.1
|
an order is made or a resolution passed for the winding-up of Profibrix (other than for the purpose of a solvent scheme of reorganisation or amalgamation);
|
11.5.2
|
Profibrix has been declared bankrupt, has been granted suspension of payment on a temporary basis or otherwise or has become subject to any other similar regulation, the foregoing irrespective of whether or not that situation is recoverable;
|
11.5.3
|
as a consequence of financial difficulties, Profibrix makes any voluntary arrangement with its creditors outside a bankruptcy, suspension of payments or any other similar regulation;
|
11.5.4
|
Profibrix ceases to continue its business;
|
11.5.5
|
Profibrix becomes unable to pay its debts as and when they fall due; or
|
11.5.6
|
as a consequence of debt and/or maladministration, Profibrix takes or suffers any similar or analogous action to those listed in Clauses 11.5.1 to 11.5.5 above.
|
12.
|
CONSEQUENCES OF EXPIRY OR TERMINATION
|
12.1
|
On expiry or termination of this Agreement for any reason:-
|
12.1.1
|
Profibrix shall within 30 days of the date of expiry or termination pay to Quadrant all sums due to it under this Agreement in respect of the period up to and including the date of expiry or termination including any royalties payable on Products supplied prior to or on the date of expiry or termination;
|
12.1.2
|
any rights or remedies of each of the parties arising from any breach of this Agreement shall continue to be enforceable notwithstanding expiry or termination; and
|
12.1.3
|
the following provisions shall continue in full force and effect Clause 1, (Definitions), Clause 5 (to the extent royalties remain outstanding). Clause 6 (Payment Terms), Clause 13 (Termination), Clause 14 (Consequences of termination) and Clause 15 (General).
|
12.2
|
On termination of this Agreement for any reason:-
|
12.2.1
|
Profibrix shall promptly reassign any Fibrocaps Patents that Quadrant has assigned to Profibrix pursuant to Clause 8.3 to Quadrant and at Quadrant’s request assign to Quadrant any Profibrix Licence Agreement;
|
12.2.2
|
the Licences shall terminate automatically and Profibrix shall, and shall procure that its Associates and Profibrix Licensees shall, forthwith cease all activities requiring a licence under the Patents.
|
12.3
|
Profibrix hereby appoints Quadrant as it attorney to effect on its behalf any assignment of the Fibrocaps Patents which Profibrix has failed to make to Quadrant within 7 days in
|
12.4
|
In the event that the Fibrocaps Patents are assigned back to Quadrant from Profibrix pursuant to Clause 8.2:-
|
12.4.1
|
Profibrix shall no longer be entitled to exploit in any way, either directly or indirectly, the Fibrocaps Patents in so far and for so long as any of the Fibrocaps Patents remain in force; and
|
12.4.2
|
Profibrix shall disclose to Quadrant all rights under licence agreements and interests granted by Profibrix or its Affiliates under the Fibrocaps Patents; and at Quadrant’s request shall assign to Quadrant the benefit of such licence agreements and interests.
|
13.
|
GENERAL
|
13.1
|
In this Agreement:-
|
13.1.1
|
“including” means including without limitation; “include” and “includes” shall be construed accordingly.
|
13.1.2
|
the headings are for convenience only and shall not affect the interpretation of this Agreement;
|
13.2
|
In the event of any inconsistency or conflict between the provisions of the main body of this Agreement (Clauses 1 - 13) and the provisions of the Schedules to this Agreement, the provisions of the main body of this Agreement shall override those of the Schedules to the extent of the inconsistency or conflict only.
|
13.3
|
Any notice or other communication given under this Agreement shall be in writing in the English language and shall be:-
|
13.3.1
|
delivered by hand; or
|
13.3.2
|
sent by pre-paid airmail; or
|
13.3.3
|
sent by fax (confirmed by pre-paid airmail placed in the post on or on the day after the date of transmission);
|
13.4
|
Any notice given under Clause 13.2 shall be deemed to have been received:-
|
13.4.1
|
on the date of delivery if delivered by hand prior to 5:00 pm on a business day, otherwise on the next business day following the date of delivery;
|
13.4.2
|
on the fifth business day from and including the day of posting in the case of pre-paid airmail; or
|
13.4.3
|
on the next business day following the day of transmission in the case of facsimile (confirmed by pre-paid first class post/airmail as provided above).
|
13.5
|
In Clause 15.3, business day shall mean a day that is not Saturday, Sunday and/or a public holiday in the country to which the notice is sent.
|
13.6
|
If any prevision of this Agreement is declared by any judicial or other competent authority to be void, voidable, illegal or otherwise unenforceable then the remaining provisions of
|
13.7
|
Failure or delay by either party to exercise any right or remedy under this Agreement shall not be deemed to be a waiver of that right or remedy, or prevent it from exercising that or any other right or remedy on that occasion or on any other occasion.
|
13.8
|
This Agreement constitutes the entire agreement and understanding of the parties relating to the subject matter of this Agreement and supersedes all prior oral or written agreements, representations, understandings or arrangements between the parties relating to the subject matter of this Agreement.
|
13.9
|
Except as expressly set forth in this Agreement, neither party grants to the other by implication, estoppel or otherwise, any right, title, licence or interest in any intellectual property right.
|
13.10
|
The parties acknowledge that they are not relying on any understanding, arrangement, statement, representation, warranty, condition or term which is not set out in this Agreement.
|
13.11
|
The parties irrevocably and unconditionally waive any rights and/or remedies they may have to the fullest extent permitted by law (including the right to claim damages and/or to rescind this Agreement) in respect of any misrepresentation other than one which is expressly stated in this Agreement or which was made fraudulently.
|
13.12
|
No provision of this Agreement shall operate to:-
|
13.12.1
|
exclude any provision implied into this Agreement by English law and which may not be excluded by English law; or
|
13.12.2
|
1imit or exclude any liability, right or remedy to a greater extent than is permissible under English law including in relation to (1) death or personal injury caused by the negligence of a party to this Agreement or (2) fraudulent misrepresentation or deceit.
|
13.13
|
No change shall be made to this Agreement except in writing in the English language signed by the duly authorised representatives of both parties.
|
13.14
|
Nothing in this Agreement shall create, evidence or imply any agency, partnership, joint venture or employment relationship between the parties.
|
13.15
|
Neither party shall act or describe itself as the agent of the other party nor shall either party have or represent that it has any authority to make commitments on behalf of the other.
|
13.16
|
This Agreement is personal to Profibrix and Profibrix shall not assign, transfer, sub-license (except as expressly provided in Clause 4), sub-contract, charge, or otherwise deal in this Agreement or any rights and obligations under this Agreement.
|
13.17
|
Quadrant shall have the right to assign this Agreement and its rights and obligations under this Agreement to an Affiliate or to any company or corporation with which it has merged or consolidated or to which it has sold all or substantially all of its assets without the consent of Profibrix, provided that Quadrant shall notify Profibrix thereof in advance. Quadrant shall have the right to assign this Agreement to a Third Party with Profibrix’s prior written consent, such consent not to be unreasonably withheld.
|
13.18
|
If a party delegates all or any of its obligations under this Agreement to any third party, the party delegating shall be fully responsible to the other party for the proper performance of those obligations and for any negligent act or omission made by the third party or its staff in relation thereto.
|
13.19
|
Except as required by law, each party shall not, and shall procure that their respective Personnel, their respective Associates and the Personnel of their respective Associates shall not, make any announcement, or comment upon, or originate any publicity, or otherwise provide any information to any third party (other than its legal advisors) concerning this Agreement including the existence of this Agreement, the terms of this Agreement, the performance of this Agreement and/or any dispute or disagreement relating to this Agreement without the prior written consent of the other party, provided, however, that either party may disclose this Agreement to potential financial investors and their advisors that are bound by confidentiality undertakings in the course of the due diligence by such potential investors.
|
13.20
|
The Contracts (Rights of Third Parties) Act 1999 and any legislation amending or replacing this Act shall not apply in relation to this Agreement or any agreement, arrangement, understanding, liability or obligation arising under or in connection with this Agreement and nothing in this Agreement shall confer on any third party the right to enforce any provision of this Agreement.
|
13.21
|
The validity, construction and performance of this Agreement shall be governed by English law and the parties irrevocably submit to the exclusive jurisdiction of the English courts in respect thereof.
|
File
Number
|
Title
|
Patent/Application Number
|
Countries
|
|
|
|
|
[**]
|
[**]
|
[**]
|
[**]
|
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
File Number
|
Title
|
Patent/Application Number
|
Countries
|
[**]
|
[**]
|
[**]
|
[**]
|
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
(1)
|
Quadrant Drug Delivery Limited
a company incorporated under the laws of England with company registration number 2704727 and whose registered office is at 1 Mere Way, Ruddington, Nottingham, NG11 6JS, England (“Quadrant”); and
|
(2)
|
Profibrix B.V.
a company registered in The Netherlands whose statutory seat is at Acacialaan 7, 2351 CA, Leiderdorp, The Netherlands (“Profibrix”).
|
(A)
|
Quadrant is the owner of (1) the patent applications set out in the Appendix (the “Patent Applications”) and (2) the granted patents set out in the Appendix (the “Granted Patents”). The Patents Applications and the Granted Patents are together referred to as “Patents”.
|
(B)
|
Quadrant and Profibrix entered into a Fibrocaps Patent Licensing Agreement dated [
insert date
] (the “Agreement”) under which Quadrant agreed to assign the Patents to Profibrix.
|
(C)
|
Quadrant is willing to assign the Patents to Profibrix and Profibrix wishes to receive the assignment of the Patents in accordance with the provisions of this Agreement.
|
1.
|
Assignment
|
1.1
|
the right in relation to infringements of the Granted Patents and any patents resulting from the Patent Applications, to recover and take all such proceedings as may be necessary for the recovery of damages or otherwise including, without limitation, the right to recover damages for past infringements;
|
1.2
|
the right to apply for and the right to be granted patent, or other protection anywhere in the world in respect of the inventions disclosed in the Patents;
|
1.3
|
all rights to claim priority anywhere in the world on the basis of the Patents;
|
1.4
|
the right to apply for extensions, renewals and Supplementary Protection Certificates in respect of the Granted Patents and any patents resulting from the Patent Applications.
|
2.
|
Further Assurances
|
3.
|
Law
|
1.
|
The Fibrocaps Patents and Patent Applications.
|
File
Number
|
Title
|
Patent/Application Number
|
Countries
|
[**]
|
[**]
|
[**]
|
[**]
|
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
||
|
|
••
|
Structure-function analysis of fibrinogen variants to determine new unique functional properties that creates product development opportunities.
|
••
|
Purification and characterization of fibrinogen variants form different sources (plasma, recombinant systems).
|
••
|
Formulation of fibrinogen variants and other components into end-products.
|
••
|
Identification of medical needs that can be treated using fibrinogen based products.
|
••
|
Selection of the fibrinogen variants with optimal functional properties for the products
|
••
|
Establishing a commercially feasible manufacturing process for this fibrinogen
|
••
|
Development of a formulation that facilitates end-product use and storage.
|
1.
|
Royalty
|
(i)
|
the Net Sales Value of Fibrocaps Products expressed both in local currency and in euros together with conversion rates used and the calculation of the royalties payable in respect of the Fibrocaps Products; and
|
(ii)
|
the Net Sales Value of Licensed Products expressed both in local currency and in euros together with conversion rates used and the calculation of the royalties payable in respect of the Licensed Products; and
|
(iii)
|
the total amount of royalties payable in respect of that country;
|
2.
|
Revenue Share
|
(i)
|
the amount of Licensing Revenue; and
|
(ii)
|
any Authorised Development Costs
|
(iii)
|
expressed both in local currency and in euros together with the conversion rates used and the calculation of any amounts payable to Quadrant pursuant to Clause 5.7.
|
3.
|
The World
|
(i)
|
the total amount of royalties payable under Clause 5.2; and
|
(ii)
|
the total amount payable under Clause 5.7; and
|
(iii)
|
the amount of any withholding tax deducted pursuant to Clause 6.4.4.
|
1.
|
Any dispute arising out of or in connection with Clause 4 of this Agreement and/or arising out of or in connection with the determination of the Net Sales Value shall be referred to an expert by either party serving on the other party notice (“Referral Notice”) that it wishes to refer the dispute to an expert.
|
2.
|
The dispute shall be determined by a single independent impartial expert who shall be agreed between the parties or, in the absence of agreement between the parties within 30 days of the service of a Referral Notice, be appointed by the then President of the Institute of Chartered Accountants or any successor organisation thereto or any successor thereto.
|
3.
|
30 days after the appointment of the expert pursuant to paragraph 2 both parties shall exchange simultaneously statements of case in no more than 10,000 words, in total, and each side shall simultaneously send a copy of its statement of case to the expert.
|
4.
|
Each party may, within 30 day s of the date of exchange of statement of case pursuant to paragraph 3, serve a reply to the other side’s statement of case in no more than 10,000 words. A copy of any such reply shall be simultaneously sent to the expert.
|
5.
|
Subject to paragraph 8, there shall be no oral hearing. The expert shall issue his decision in writing to both parties within 30 days of the date of service of the last reply pursuant to paragraph 4 above or, in the absence of receipt of any replies, within 60 days of the date of exchange pursuant to paragraph 3.
|
6.
|
The seat of the dispute resolution shall be the normal place of residence of the expert.
|
7.
|
The language of the dispute resolution shall be English.
|
8.
|
The expert shall not have power to alter, amend or add to the provisions of this Agreement, except that the expert shall have the power to decide all procedural matters relating to the dispute, and may call for a one day hearing if desirable and appropriate.
|
9.
|
The expert shall have the power to request copies of any documents in the possession and/or control of the parties which may be relevant to the dispute. The parties shall forthwith provide to the expert and the other party copies of any documents so requested by the expert.
|
10.
|
The expert shall decide the dispute as an expert and not as an arbitrator.
|
11.
|
The decision of the expert shall be final and binding upon both parties except in the case of manifest error. The parties hereby exclude any rights of application or appeal to any court,
|
12.
|
The expert shall determine the proportions in which the parties shall pay the costs of the expert’s procedure. The expert shall have the authority to order that all or a part of the legal or other costs of a party shall be paid by the other party.
|
13.
|
All documents and information disclosed in the course of the expert proceedings and the decision and award of the expert shall be kept strictly confidential by the recipient and shall not be used by the recipient for any purpose except for the purposes of the proceedings and/or the enforcement of the expert’s decision and award
|
EXECUTED and DELIVERED as a DEED by )
Quadrant Drug Delivery Limited
acting by )
two of its Directors or by its Company )
Secretary and one of its Directors )
|
Signed:
/s/ David Lewis
Full Name:
David Lewis
Director
/Company Secretary:
Signed:
/s/ Rajan Uppal
Full Name:
Rajan Uppal
Director
|
EXECUTED and DELIVERED as a DEED by )
Profibrix B.V.
, acting by two of its Directors or by )
its Company Secretary and one of its Directors
)
)
|
Signed:
Full Name:
Director/Company Secretary:
Signed:
/s/ Jacob Laurens Koopman
Full Name:
Jacob Laurens Koopman
Director
JL Koopman is acting in his capacity as sole statutory director of ERTKO B.V., the latter being the sole statutory director of ProFibrix B.V.
|
“1.37 “Issuance Date 1”
|
shall have the meaning given in Clause 2.4 of the Subscription and Shareholders Agreement between Profibrix N.V. and certain shareholders of Profibrix as of the date hereof.”
|
9.1
|
Quadrant warrants to Profibrix that, except as disclosed in Clause 9.5, at the Amendment Date:-
|
9.1.1
|
Quadrant is the sole legal and beneficial owner of the Fibrocaps Patents;
|
9.1.2
|
Quadrant has not granted any rights under Fibrocaps Patents to third parties in the Fibrocaps Field and has not granted any exclusive right under the Fibrocaps Patents to third parties outside of the Fibrocaps Field;
|
9.1.3
|
Quadrant is the owner of the Licensed Patents and has the right to grant the Licences;
|
9.1.4
|
the Granted Patents set out in Schedule 1 of the Agreement are subsisting and all payments due to patent offices in respect of the registration, and maintenance of the Granted Patents set out in Schedule 1 of the Agreement prior to the Amendment Date have been paid;
|
9.1.5
|
to the best of Quadrant’s knowledge Quadrant has not received notice that interference and/or opposition proceedings have been initiated against any of the Fibrocaps Patents;
|
9.1.6
|
none of the Fibrocaps Patents is subject to any encumbrance; and
|
9.1.7
|
to the best of Quadrant’s knowledge Quadrant has not been made aware pursuant to a written statement from a third party received in respect of a granted Fibrocaps Patent after the date of grant of such Fibrocaps Patent (excluding any written statements received from (i) Profibrix; and/or (ii) an Associate of Profibrix; and/or (iii) a former Associate of Profibrix) that any claim or objections are pending or threatened against Quadrant with respect to the validity, enforceability or ownership of such granted Fibrocaps Patent.
|
9.2
|
Where any of the warranties set out in Clause 9.1 are qualified by the expression “to the best of Quadrant’s knowledge” the relevant knowledge in that context shall be deemed to be and limited to the actual knowledge of Colin Dalton as at the Amendment Date, it being understood and acknowledged that he has not made any specific enquiries.
|
9.3
|
All statements and representations (other than fraudulent misrepresentations), warranties, terms and conditions (except for those set out in the Agreement as amended by Amendment Deed No. 1) including any implied by statute, common law or otherwise are hereby excluded to the maximum extent permissible by law.
|
9.4
|
Without prejudice to the generality of Clause 9.3 and save for the warranties set out in Clause 9.1, Quadrant does not give any warranty, representation or undertaking:-
|
9.4.1
|
as to the efficacy, usefulness, safety or commercial or technical viability of the Technology and/or any products made or processes carried out using the Technology;
|
9.4.2
|
that any of the Granted Patents is or will be valid or that any of Patent Applications will results in the grant of a valid patent;
|
9.4.3
|
that the Technology can be freely exploited in all or any parts of the world;
|
9.4.4
|
that the technology will not infringe the Intellectual Property Rights or other rights of any third party; and/or
|
9.4.5
|
that a Patent will be upheld or continue in force if that Patent is the subject of interference proceedings or other similar proceedings.
|
9.5
|
Some of the Licensed Patents may have lapsed or been abandoned.”
|
EXECUTED and DELIVERED as a DEED by
Quadrant Drug Delivery Limited
acting by two of its Directors or by its Company Secretary and one of its Directors
EXECUTED and DELIVERED as a DEED by
Profibrix B.V.
through Jacob Laurens Koopman , who is permitted to sign in accordance with the laws of the Netherlands
|
)
) ) )
)
) ) ) |
Signed:
/s/ Lee Coleman
Full Name:
Lee Coleman
Company Secretary
Signed:
/s/ Colin Dalton
Full Name:
Colin Dalton
Director
Signed:
/s/ Jacob Laurens Koopman
Full Name: Jacob Laurens Koopman
Sole Statutory Director of Ertko B.V., the latter being the sole Statutory Director of Profibrix B.V.
|
(1)
|
Quadrant Drug Delivery Limited, a company incorporated under the laws of England with company registration number 2704727 and whose registered office is at 1 Mere Way, Ruddington, Nottingham, NG11 6JS, United Kingdom (“Quadrant”); and
|
(2)
|
ProFibrix B.V., a company registered in The Netherlands whose statutory seat is at Acacialaan 7, 2351 CA, Leiderdorp, The Netherlands (“ProFibrix”)
|
(A)
|
Quadrant and ProFibrix entered into a Fibrocaps Patent Licensing Agreement dated 25 October 2004 (the “Agreement”).
|
(B)
|
Quadrant and ProFibrix amended the Agreement pursuant to Amendment Deed No. 1 dated 14 February 2007 (“Amendment Deed No.1”).
|
(C)
|
Quadrant and ProFibrix now wish to further amend the Agreement in accordance with the provisions set out in this Amendment Deed No. 2.
|
1.
|
DEFINITIONS
|
1.1
|
The following new definitions will be included in Clause 1 of the Agreement:-
|
“Change of Control”
|
occurs if a person, body corporate or other legal entity who controls ProFibrix ceases to do so, or if another person, body corporate or other legal entity acquires control of ProFibrix. “Control” shall exist through the direct or indirect ownership and/or control of more than fifty per cent of the voting shares of ProFibrix;
|
“Competing Product”
|
a dry powder product which, were it to be manufactured and/or supplied in the US, would fall within the scope of the US Fibrocaps Patent ([**]);
|
“CRO”
|
a provider of contract research services contracted by ProFibrix to carry out pre-clinical research and/or clinical research and /or clinical trials;
|
“Exclusivity Period”
|
the period commencing on 12 June 2007 and ending on the 1 February 2008;
|
“Fibrocaps Know-How”
|
the Know-How as at 12 June 2007 useful in the Fibrocaps Field and as outlined in Schedule 7;
|
“Joint IPRs”
|
shall have the meaning given to that term in Clause 1.12 of the Research and Development Agreement entered into by ProFibrix on 12 June 2007;
|
“Know-How”
|
shall mean all secret and substantial know-how developed and owned by Quadrant;
|
“Know-how Product”
|
shall mean any product which utilises Fibrocaps Know-How;
|
“ProFibrix Project IPRs”
|
shall mean Project IPRs belonging to ProFibrix pursuant to Clause 7.3 of the R&D Agreement;
|
“Project IPRs”
|
shall have the meaning given to that term in Clause 1.17 of the R&D Agreement;
|
“Quadrocytes Patents”
|
the patents means the patents listed in Schedule 8;
|
“Quadrant Product”
|
shall mean any product, including any pharmaceutical formulation of such product or any variant thereof whose development, manufacture, import, marketing, use, sale or supply falls within the scope of one or more claims of a patent forming part of the ProFibrix Project IPRs subsisting in the country in which such manufacture, sale and/or supply took place;
|
“R&D Agreement”
|
the Research and Development Agreement entered into by ProFibrix and Quadrant on 12 June 2007;
|
“RPI”
|
the Retail Prices Index issued by the United Kingdom Office for National Statistics (published at www.statistics.gov.uk) or such other appropriate official index as may replace the same to measure the costs of living in the United Kingdom; and
|
“Wound Healing Field”
|
a pharmaceutical formulation that does not fall within the Excluded Field and/or Fibrocaps Field comprising spray dried human fibrinogen or variants thereof and/or thrombin but excluding any other APIs for administration to humans for the sole purposes of wound healing and/or vascular support.
|
1.2
|
All references to “party” in Clause 1.1 of the Agreement shall be deleted and replaced with the word “entity”.
|
1.3
|
The words “but excluding nucleic acid” set out at the end of Clause 1.9a of the Agreement shall be deleted.
|
1.4
|
Clause 1.9(d) shall be deleted from the Agreement, and the following words shall be inserted in the Agreement as new Clauses 1.9(d) to 1.9(g) in the definition of “Excluded Field”:-
|
1.5
|
The words “and/or for the prevention of post surgical adhesions” shall be included at the end of the definition of “Fibrocaps Field” in Clause 1.10;
|
1.6
|
The words “as of the date hereof” in the definition of “Issuance Date 1” in Clause 1.37 of the Agreement shall be deleted and replaced with the words “dated 14th February 2007”.
|
1.7
|
The words “and 3.3A, 3.3B, 3.3C and 3.3E” shall be inserted after the words “and 3.3” at the end of the definition of “Licences” in Clause 1.17 of the Agreement.
|
1.8
|
Clause 1.20 shall be deleted and replaced in its entirety with the following:-
|
“1.20
|
“Licensing Revenues” any sums or other consideration received by ProFibrix and/or its Associates in respect of the licensing of the Patents including any sums received under any ProFibrix Licence Agreements but excluding;
|
(a)
|
sums received by ProFibrix and/or its Associates in respect of royalties under this Agreement.
|
(b)
|
payments received by ProFibrix for development work carried out by ProFibrix provided that such payments will only be excluded to the extent such payments do not exceed the then prevailing fair market rate payable for the type of work carried out. Any dispute as to the determination of a fair market rate that cannot be resolved through discussion between the parties shall be
|
1.9
|
The words “and/or Know-how Products” shall be inserted at the end of the definition of “Products” in Clause 1.26.
|
1.10
|
The words “and/or the Wound Healing Field” shall be inserted al the end of the definitions of “ProFibrix Licence Agreement” in Clause 1.27.
|
1.11
|
The definition of “Sub-licence Agreement” shall be amended as follows:
|
(a)
|
in respect of ProFibrix, any agreement between ProFibrix and a ProFibrix Sub-licensee; and
|
(b)
|
in respect of Quadrant, any agreement between Quadrant and a Quadrant Sub-licensee (as the case may be);”
|
1.12
|
The definition of “Sub-licensee” in Clause 1.32 of the Agreement shall be amended as follows:
|
“1.32 “Sub-licensee
|
shall mean:
|
|
(a) in respect of ProFibrix, a third party (including an Associate of ProFibrix) to whom ProFibrix has directly or indirectly sub-licensed, sub-contracted or otherwise transferred any of ProFibrix’s rights and/or obligations under this Agreement (a ProFibrix Sub-licensee); and
(b) means in respect of Quadrant, a third party (including an Associate of Quadrant) to whom Quadrant has directly or indirectly sub-licensed, sub-contracted or otherwise transferred any of Quadrant’s rights and/or obligations under this Agreement (a “Quadrant Sub-licensee”);”
|
1.13
|
the definition of “Fibrocaps Product” in Clause 1.14 of the Agreement shall be amended as follows:-
|
“1.14 “Fibrocaps Product”
|
any product (including any pharmaceutical formulation comprising spray dried fibrinogen and/or thrombin microcapsules or any variant thereof) whose manufacture, sale and/or supply falls within the scope of one or more claims of any Fibrocaps Patent subsisting in the country in which such manufacture, sale and/or supply took place.”
|
1.14
|
The words “Fibrocaps Products” in the definition of “Marketing Partners” shall be replaced with the word “Products”.
|
2.
|
LICENCES
|
2.1
|
The words “and a non-transferable, worldwide, non-exclusive licence under the Fibrocaps Know-How” shall be inserted after the words “Fibrocaps Patents” in Clause 3.1 of the Agreement.
|
2.2
|
New Clauses 3.3A, 3.3B, 3.3C, 3.3D, 3.3E and 3.3F shall be included in the Agreement as follows:-
|
“3.3A
|
Quadrant grants to ProFibrix a non-transferable, worldwide, exclusive licence under the Fibrocaps Patents and a non-transferable, worldwide, non-exclusive licence under the Fibrocaps Know-How to develop, use, manufacture and sell products within the Wound Healing Field.
|
3.3B
|
Quadrant grants to ProFibrix a non-transferable, worldwide, non-exclusive licence under the Licensed Patents to develop, use, manufacture and sell products within the Wound Healing Field.
|
3.3C
|
Quadrant grants ProFibrix a non-transferable, exclusive, royalty-free, worldwide licence under the Project IPRs owned by Quadrant to develop, use, manufacture and sell products within the Fibrocaps Field and the Wound Healing Field together with the right to sub-license subject to the provisions of Clauses 3.5 to 3.9;
|
3.3D
|
ProFibrix grants to Quadrant a non-transferable, exclusive, worldwide licence under the ProFibrix Project IPRs to develop, use manufacture and sell products other than the Fibrocaps Products, outside the Fibrocaps Field and Wound Healing Field together with the right to sub-license subject to the provisions of Clauses 3.5 to 3.8;
|
3.3E.
|
Quadrant grants to ProFibrix a non-transferable, exclusive, royalty-free, worldwide right under any Joint IPRs to develop, use, manufacture and sell products within the Fibrocaps Field and Wound Healing Field together with the right to sub-license; and
|
3.3F
|
ProFibrix grants to Quadrant a non-transferable exclusive royalty-free, worldwide right under any Joint IPRs to develop, use, manufacture and sell products outside the Fibrocaps Field and Wound Healing Field, together with the right to sub-license.
|
3.
|
SUB-LICENSING
|
3.1
|
Clause 3 of the Agreement shall be amended by deleting the existing Clauses 3.5, 3.6 and 3.7 and replacing them with new Clauses 3.5 to 3.9 as follows:
|
“3.5
|
The parties shall have the right to grant sub-licences under the Licence and under Clauses 3.3D (“the Quadrant Licences”) provided that such party enters into a written agreement with each Sub-licensee and ensures that:
|
3.5.1
|
the provisions of the Sub-licence Agreement are entirely consistent with the provisions of this Agreement;
|
3.5.2
|
the Sub-licence Agreement shall terminate automatically if this Agreement expires or is terminated;
|
3.5.3
|
each Sub-licensee complies fully at all times with the provisions of its Sub-licence Agreement;
|
3.5.4
|
the Sub-licensee is not entitled to and does not grant further sub-licences in respect of (a) in the case of ProFibrix, the Licensed Patents without the prior written consent of Quadrant; and (b) in the case of Quadrant, the Quadrant Licenses without the prior written consent of ProFibrix.
|
3.6
|
ProFibrix shall be responsible to Quadrant for all acts and/or omissions of each ProFibrix Sub-licensee as if such acts or omissions had been made by ProFibrix and Quadrant shall be responsible to ProFibrix for all acts and/or omissions of each Quadrant Sub-licensee as if such acts or omissions had been made by Quadrant in each case only to the extent that any such act or omission would, if it had been made by Quadrant or ProFibrix (as the case may be), have been a breach of this Agreement.
|
3.7
|
(a) ProFibrix shall not enter into any Sub-licence Agreement, waive or otherwise agree not to assert the Patents without obtaining Quadrant’s prior written approval of the Sub-licence Agreement, waiver or non-assertion agreement. Quadrant shall not unreasonably withhold or unreasonably condition its approval to ProFibrix entering into a Sub-licence Agreement provided that it shall be reasonable for Quadrant to withhold or condition its approval to a Sub-licence Agreement if:
|
(i)
|
the terms of the Sub-licence Agreement are materially different to those of this Agreement; and/or
|
(ii)
|
Quadrant reasonably believes that any consideration paid under another transaction entered into by ProFibrix and/or its Associates is paid in relation to, or is linked to, the grant of the licences under the Sub-licence Agreement; and
|
(b)
|
Quadrant shall not enter into any Sub-licence Agreement, waive or otherwise agree not to assert the rights granted under the Quadrant Licences without obtaining ProFibrix’s prior written approval of the Sub-licence Agreement, waiver or non-assertion agreement. ProFibrix shall not unreasonably withhold or unreasonably condition its approval to Quadrant entering into a Sub-licence Agreement provided that it shall be reasonable for ProFibrix to withhold or condition its approval to a Sub-licence Agreement if:
|
(i)
|
the terms of the Sub-licence Agreement are materially different to those of this Agreement; and/or
|
(ii)
|
ProFibrix reasonably believes that any consideration paid under another transaction entered into by Quadrant and/or its Associates is paid in relation to, or is linked to,
|
3.8
|
A party shall, when seeking the other party’s consent to sub-licence pursuant to Clause 3.7, provide such other party with full details of the proposed sub-licensing arrangement and, in the case of ProFibrix, any associated transactions including any equity arrangements which:
|
3.8.1
|
form part of and/or are linked to such sub-licensing arrangements; and/or
|
3.8.2
|
are entered into with the proposed Sub-licensee or any of its Associates.
|
3.9
|
Notwithstanding the provisions of Clause 3.7, ProFibrix shall not be required to obtain Quadrant’s consent when sub-licensing the Patents to CROs solely for the purposes of enabling such CROs to carry out development work for ProFibrix provided that:
|
3.9.1
|
such work is paid for by ProFibrix at no more than the then prevailing fair market rates payable for the work carried out. Any dispute as to the determination of a fair market rate that cannot be resolved through discussion between the parties shall be referred to an expert for resolution in accordance with the provisions of Schedule 6; and
|
3.9.2
|
the CRO is not a potential Sub-licensee that would be interested in taking a licence from ProFibrix to enable it to manufacture and/or supply Products to third parties; and
|
3.9.3
|
ProFibrix complies with the provisions of Clause 3.5 in respect of such sub-licensing.”
|
4.
|
ROYALTIES
|
4.1
|
The existing Clause 4.2 of the Agreement shall be deleted and replaced with the following:
|
“4.2
|
ProFibrix shall pay to Quadrant a royalty of [**]% of the Net Sales Value of Fibrocaps Products manufactured, sold and/or supplied by ProFibrix, its Associates and/or ProFibrix Licensees.”
|
4.2
|
New Clauses 4.2A – 4.2C shall be included in the Agreement as follows:
|
“4.2A
|
ProFibrix shall pay to Quadrant a royalty of [**]% on a country by country basis of the Net Sales Value of Know-how Products manufactured, sold and/or supplied by ProFibrix, its Associates and/or ProFibrix Licensees provided that such royalty will be reduced to [**]% in relation to sales or supplies of Know-how Products in a country (i) where a royalty is payable pursuant to this Clause 4.2A and pursuant to Clause 4.3 in relation to such sales or supplies; and (ii) where Competing Product have more than [**]% of the market share attained by Know-how Products before such Competing Products were first sold in such country. ProFibrix shall not be required to pay a royalty under this Clause 4.2A in respect of a unit of Know-how Product if ProFibrix is required to pay a royalty under Clause 4.2 in respect of that unit of Know-how Product under the Licences.
|
4.2B
|
Quadrant shall pay ProFibrix a royalty of [**]% on a country by country basis of the Net Sales Values of Quadrant Products manufactured, sold and/or supplied by Quadrant, its Associates and/or Quadrant Licensees.
|
4.2C
|
The royalty payable under Clause 4.2A shall cease to be payable on Know-how Products manufactured, sold and/or supplied in a country ten (10) years from the date a Know-how Product was first put on the market in that country.
|
4.3
|
The reference (“[**]%”) in Clause 4.3 of the Agreement shall be deleted and replaced with the reference “[**]%”. The following words shall be included at the end of Clause 4.3:
|
5.
|
REVENUE SHARE
|
“4.8
|
ProFibrix shall pay to Quadrant [**]% of all Licensing Revenues received by ProFibrix and/or its Associates in accordance with this Agreement.”
|
6.
|
MINIMUM PAYMENTS
|
6.1
|
A new Clause 4.10 shall be included in the Agreement as follows:-
|
4.10
|
If in any calendar year the total amount paid by ProFibrix to Quadrant pursuant to Clauses 4.2, 4.2A, 4.3 and 4.8 is less than the minimum payments set out in the table below for that calendar year, and ProFibrix does not pay to Quadrant the deficit by 31 December of that calendar year then the licences set out in Clauses 3.3A and 3.3B will terminate automatically and ProFibrix shall, and shall procure that its Associates and ProFibrix Licensees shall forthwith cease all activities requiring a licence under Clauses 3.3A and/or 3.3B. Where Quadrant has been paid amounts due under Clauses 4.2, 4.2A, 4.3 and 4.8 in Euros then for the purposes of determining whether the minimum payments have been made, ProFibrix will convert the amount paid in the relevant calendar year in Euros into pounds sterling at the open middle market rate of exchange in London as published in the Financial Times (or failing that such other published source as ProFibrix may reasonably select) prevailing at the time the minimum annual payment is made. Any sums payable under the Clause 4.10 shall be paid in pounds sterling.
|
Calendar Year
|
Minimum Payment
|
Calendar year ending 31 December 2008
|
£[**]
|
Calendar year ending 31 December 2009
|
£[**]
|
Calendar year ending 31 December 2010
|
£[**]
|
7.
|
CHANGE OF CONTROL
|
7.1
|
The following shall be included as a new Clause 4.11 and 4.12 in the Agreement:
|
4.11
|
If there is a Change of Control of ProFibrix, then ProFibrix shall pay to Quadrant forthwith a one-off payment of two million pounds (£2,000,000) provided that this Clause 4.11 shall not apply to any future investments in ProFibrix by (i) Index Ventures; or (ii) any other investment company whose sole or main purpose is to sell equity in that company to individuals and invest in securities issued by other companies.
|
4.12
|
With effect from the date of receipt in full of a payment under Clause 4.11, Quadrant will cease to be entitled to receive pursuant to Clause 4.8 a share of any future Licensing Revenue receivable by ProFibrix after the date of receipt of such payment. For the avoidance of doubt, Quadrant will continue to be entitled to receive royalties under Clause 4 notwithstanding that a payment has been made to Quadrant pursuant to this Clause 4.11 For the avoidance of doubt such Change of Control Payment shall be payable only once during the term of this Agreement.”
|
8.
|
The following shall be included as a new Clause 4A in the Agreement:-
|
4А.1
|
Quadrant grants to ProFibrix an exclusive right to negotiate during the Exclusivity Period to receive a non-transferable, worldwide, exclusive licence under the Quadrocytes Patents and related know-how to develop, use, manufacture and sell products within the Wound Healing Field.
|
4A.2
|
ProFibrix shall pay to Quadrant on 12 June 2007 the sum of [**] (£[**]) in consideration of Quadrant granting the Exclusivity Period.
|
4A.3
|
During the Exclusivity Period, Quadrant shall not enter into any discussions with or actively respond to any proposal or offer from any third party to obtain a licence under the Quadrocytes Patents in the Wound Healing Field.
|
4A.4
|
Quadrant’s obligation under Clause 4A.3 shall terminate:-
|
4A.4.1
|
on 1 November 2007 if ProFibrix has not commenced negotiations in good faith with Quadrant for a licence of the Quadrocytes Patents; or
|
4A.4.2
|
on 1 February 2008 if an agreement for the licensing of the Quadrocytes Patents to ProFibrix has not been executed by Quadrant and ProFibrix.
|
4A.5
|
During the Exclusivity Period Quadrant will not grant any right to any third party under the Quadrocytes Patents and/or Quadrocytes Know-How to develop, use, manufacture and sell products within the Wound Healing Field.”
|
9.
|
PAYMENT TERMS
|
10.
|
WARRANTIES
|
10.1
|
The references to “Amendment Date” in Clauses 9.1 and 9.2 of the Agreement shall be deleted and replaced with references to “Issuance Date 1.
|
11.
|
EXPIRY AND TERMINATION
|
11.1
|
The existing Clause 11.1 of the Agreement shall be deleted and replaced with the following:
|
“11.1
|
Unless terminated earlier in accordance with the provisions of this Agreement, this Agreement shall expire upon the cessation of all obligations to pay royalties pursuant to Clause 4.”
|
12.
|
REVENUE STATEMENT INFORMATION
|
12.1
|
Schedule 5 of the Agreement shall be amended as follows:
|
12.1.1
|
The first sentence of the existing paragraph 1 shall be deleted and replaced as follows:
|
12.1.2
|
to include a new paragraph 1(i)(a) as follows:
|
“1(i)(a)
|
the Net Sales Value of Know-how Products expressed both in local currency and in euros together with conversion rates used and the calculation of the royalties payable in respect of Know-how Products; and”
|
12.1.3
|
the references to “Clause 5.7” in paragraph 2(iii) and paragraph 3(ii) shall be amended to refer to Clause 4.8; and
|
12.1.4
|
the reference to “Clause 6.4.4” in paragraph 3(iii) shall be amended to refer to Clause 5.4.4.
|
13.
|
NEW SCHEDULES
|
13.1
|
The Agreement shall be amended to include a new Schedule 7 (Fibrocaps Know-How) in the form set out in Annex 1 to this Amendment Deed No.2.
|
13.2
|
The Agreement shall be amended to include a new Schedule 8 (Quadrocytes Patents) in the form set out in Annex 2 to this Amendment Deed No.2.
|
14.
|
AMENDED SCHEDULE
|
14.1
|
The table of Fibrocaps patents set out in Schedule 1 shall be deemed amended to reflect the fact that a Fibrocaps Patent has now been granted in Canada (Patent No. 2253412).
|
15.
|
DEVELOPMENT OF FIBROCAPS PRODUCTS
|
16.
|
MISCELLANEOUS
|
16.1
|
The amendments set out in this Deed of Amendment No. 2 shall take effect from the date set out at the start of this Deed of Amendment No. 2.
|
16.2
|
The Agreement shall continue in full force and effect subject only to the amendments set out in Amendment Deed No. 1 and this Amendment Deed No. 2.
|
16.3
|
The validity, construction and performance of this Amendment Deed No. 2 shall be governed by English law and the parties irrevocably submit to the exclusive jurisdiction of the English courts in respect thereof.
|
1.
|
Technical reports
|
Number
|
Author
|
Title
|
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
|
[**]
|
[**]
|
[**]
|
5.
|
Trehalose Reports
|
File Number
|
Title
|
Patent/Application Number
|
Countries
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
EXECUTED and DELIVERED as a DEED by
Quadrant Drug Delivery Limited
acting by two of its Directors or by its Company Secretary and one of its Directors
EXECUTED and DELIVERED as a DEED by
Profibrix B.V.
through Jaap Koopman, who is permitted to sign in accordance with the laws of the Netherlands
|
)
) ) )
)
) ) ) |
Signed:
/s/ Lee Coleman
Full Name:
Lee Coleman
Company Secretary
Signed:
/s/ Colin Coleman
Full Name:
Colin Coleman
Director
Signed:
/s/ Jaap Koopman
Jaap Koopman
Sole Statutory Director
|
Notices to Quadrant:
|
Notices to Profibrix:
|
The Company Secretary
Quadrant Drug Delivery Limited
One Prospect West
Chippenham
Wiltshire
SN 14 6FH
UK
Fax: +44 1249 667 701
|
CEO
Profibrix B.V.
Zernikedreef 9,
2333CK,
Leiden
The Netherlands
|
EXECUTED and DELIVERED as a DEED by )
Quadrant Drug Delivery Limited
acting by two of
its Directors or by its Company Secretary and one of )
its Directors.
)
)
|
Signed:
/s/ Anne Hyland
Full Name:
Anne Hyland
Director/Company Secretary
Signed:
/s/ Christopher Blackwell
Full Name:
Christopher Blackwell
Director
|
EXECUTED and DELIVERED as a DEED by
ProFibrix B.V.
through Jaap Koopman. who is
permitted to sign in accordance with the laws of the )
Netherlands.
)
)
)
|
Signed:
/s/Jacob Koopman
Jacob Laurens Koopman
Acting in his capacity as CSO and statutory Director of ProFibrix B.V.
|
Internal
Family Ref |
Country
Code |
Application No
|
Patent No
|
Type
|
Status
|
Filing Date
|
Expiry Date
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
Internal
Family Ref |
Country
Code |
Application No
|
Patent No
|
Type
|
Status
|
Filing Date
|
Expiry Date
|
||
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
Internal
Family Ref |
Country
Code |
Application No
|
Patent No
|
Type
|
Status
|
Filing Date
|
Expiry Date
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
[**]
|
Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Double asterisks denote omissions.
|
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 Second Amendment dated September 1, 2011 and the Third Amendment dated April 23, 2012 (the “Agreement”);
|
B.
|
Under 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 6.1.1 (c) 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.
|
THE MEDICINES COMPANY
|
By:
/s/ Stephen W. McKinnon
|
By:
/s/ Tanya Quinn 4/29/13
|
Name:
Stephen W. McKinnon
|
Name:
Tanya Quinn
|
Title:
SVP, GM
|
Title: VP, Global Distribution & Supply
Chain
|
Product Name:
|
ANGIOMAX® (bivalirudin) for Injection
|
NDC#
|
65293-001-01
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Carton (10 single use vials)
|
Dosage Form:
|
250mg vial
|
Current WAC Price*:
|
$[**] per Carton, (*which may change from time to time at MDCO’s sole discretion)
|
Case Pack Size
|
Thirty (30) Cartons
|
Shipping and Storage Requirements:
|
20 to 25ºC
|
|
|
Product Name:
|
ANGIOMAX® (bivalirudin) Nova Plus for Injection
|
NDC#
|
65903-004-22
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Carton (10 single use vials)
|
Dosage Form:
|
250mg vial
|
Current WAC Price*:
|
$[**] per Carton, (*which may change from time to time at MDCO’s sole discretion)
|
Case Pack Size
|
Thirty (30) Cartons
|
Shipping and Storage Requirements:
|
20 to 25ºC
|
|
|
Product Name:
|
ARGATROBAN for Injection
|
NDC#
|
42367-203-84
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Carton (10 single use vials)
|
Dosage Form:
|
50mg vial
|
Current WAC Price*:
|
$[**] Carton, (*which may change from time to time at MDCO’s sole discretion)
|
Case Pack Size
|
Four (4) Cartons
|
Shipping and Storage Requirements:
|
20 to 25ºC
|
|
|
Product Name:
|
Cleviprex® (clevidipine) Injectable Emulsion
|
NDC#
|
6593-005-11
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Carton (10 single use vials)
|
Dosage Form:
|
50mg vial
|
Current WAC Price*:
|
$[**] Carton, (*which may change from time to time at MDCO’s sole discretion)
|
Case Pack Size
|
Six (6) Cartons
|
Shipping and Storage Requirements:
|
2 to 8ºC
|
|
|
Product Name:
|
Cleviprex® (clevidipine) Injectable Emulsion
|
NDC#
|
6593-005-55
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Carton (10 single use vials)
|
Dosage Form:
|
25mg vial
|
Current WAC Price*:
|
$[**] Carton, (*which may change from time to time at MDCO’s sole discretion)
|
Case Pack Size
|
Twelve (12) Cartons
|
Shipping and Storage Requirements:
|
2 to 8ºC
|
|
|
Product Name:
|
Rocuronium 50mg/5ml (2-8C)
|
NDC#
|
6529342610
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Carton (10 single use vials)
|
Dosage Form:
|
50mg vial 10mg/ml
|
Current WAC Price*:
|
$[**]
|
Case Pack Size
|
48 cartons
|
Shipping and Storage Requirements:
|
2 to 8ºC
|
|
|
Product Name:
|
Rocuronium 100mg/10ml
|
NDC#
|
6529342710
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Carton (10 single use vials)
|
Dosage Form:
|
100mg vial 10mg/ml
|
Current WAC Price*:
|
$[**]
|
Case Pack Size
|
48 cartons
|
Shipping and Storage Requirements:
|
2 to 8ºC
|
|
|
Product Name:
|
Ondansetron 4mg/2ml
|
NDC#
|
6529337325
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Carton (25 single use vials)
|
Dosage Form:
|
4mg vial 2mg/ml
|
Current WAC Price*:
|
$[**]
|
Case Pack Size
|
40 cartons
|
Shipping and Storage Requirements:
|
20 to 25ºC PROTECT FROM LIGHT
|
|
|
Product Name:
|
Ondansetron 40mg/20ml
|
NDC#
|
6529337401
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Carton (1 single use carton)
|
Dosage Form:
|
40mg vial 2mg/ml
|
Current WAC Price*:
|
$[**]
|
Case Pack Size
|
100 cartons
|
Shipping and Storage Requirements:
|
20 to 25ºC PROTECT FROM LIGHT
|
|
|
Product Name:
|
Midazolam 2mg/2ml CIV
|
NDC#
|
6529341125
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Carton (25 single use vials)
|
Dosage Form:
|
2mg vial 1mg/1ml
|
Current WAC Price*:
|
$[**]
|
Case Pack Size
|
40 cartons
|
Shipping and Storage Requirements:
|
20 to 25ºC
|
|
|
Product Name:
|
Midazolam 10mg/2m CIV
|
NDC#
|
6529341210
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Cartons (10 single use vials)
|
Dosage Form:
|
10mg vial 1mg/1ml
|
Current WAC Price*:
|
$[**]
|
Case Pack Size
|
48 cartons
|
Shipping and Storage Requirements:
|
20 to 25ºC
|
|
|
Product Name:
|
Midazolam 10mg/2ml CIV
|
NDC#
|
6529341310
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Carton (10 single use vials)
|
Dosage Form:
|
10mg vial 5mg/1ml
|
Current WAC Price*:
|
$[**]
|
Case Pack Size
|
48 cartons
|
Shipping and Storage Requirements:
|
20 to 25ºC
|
Product Name:
|
Midazolam 25mg/5ml CIV
|
NDC#
|
6529341410
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Carton (10 single use vials)
|
Dosage Form:
|
25mg vial 5mg/ml
|
Current WAC Price*:
|
$[**]
|
Case Pack Size
|
48 cartons
|
Shipping and Storage Requirements:
|
20 to 25ºC
|
|
|
Product Name:
|
Midazolam 50mg/10ml CIV
|
NDC#
|
6529341510
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Carton (10 single use vials)
|
Dosage Form:
|
50mg vial 5mg/ml
|
Current WAC Price*:
|
$[**]
|
Case Pack Size
|
48 cartons
|
Shipping and Storage Requirements:
|
20 to 25ºC
|
|
|
Product Name:
|
Midazolam 5mg/5ml CIV
|
NDC#
|
6529341625
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Carton (25 single use vials)
|
Dosage Form:
|
5mg vial 1mg/1ml
|
Current WAC Price*:
|
$[**]
|
Case Pack Size
|
30 cartons
|
Shipping and Storage Requirements:
|
20 to 25ºC
|
|
|
Product Name:
|
Midazolam 5mg/1ml CIV
|
NDC#
|
6529341725
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Carton (25 single use vials)
|
Dosage Form:
|
5mg vial 5mg/1ml
|
Current WAC Price*:
|
$[**]
|
Case Pack Size
|
40 cartons
|
Shipping and Storage Requirements:
|
20 to 25ºC
|
|
|
Product Name:
|
Recothrom Spray Kit Only
|
NDC#
|
28400070017
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Carton
|
Dosage Form:
|
N/A
|
Current WAC Price*:
|
$[**]
|
Case Pack Size
|
6 cartons
|
Shipping and Storage Requirements:
|
20 to 25ºC
|
|
|
Product Name:
|
Recothrom 5,000 IU Kit
|
NDC#
|
28400010541
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Carton
|
Dosage Form:
|
5,000 IU
|
Current WAC Price*:
|
$[**]
|
Case Pack Size
|
12 cartons
|
Shipping and Storage Requirements:
|
20 to 25ºC
|
|
|
Product Name:
|
Recothrom 20,000 IU Kit
|
NDC#
|
28400012041
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Carton
|
Dosage Form:
|
20,000 IU
|
Current WAC Price*:
|
$[**]
|
Case Pack Size
|
6 cartons
|
Shipping and Storage Requirements:
|
20 to 25ºC
|
|
|
Product Name:
|
Recothrom 20,000 IU Kit w/spray
|
NDC#
|
28400012050
|
Drug Type:
|
RX
|
Sellable Package Size:
|
Carton
|
Dosage Form:
|
20,000 IU
|
Current WAC Price*:
|
$[**]
|
Case Pack Size
|
6 cartons
|
Shipping and Storage Requirements:
|
20 to 25ºC
|
Services
|
Fee
|
A.
Marketing, Sales, Customer Service and Distribution
|
|
Fees include the following
|
Percentage of WAC
( see below ) |
§
Warehousing Management and Inventory Administration
|
|
§
Customer Service/Order Entry
|
|
§
Marketing and Distribution Services
|
|
§
Invoicing and Accounts Receivable Management
|
|
§
Direct Account Set Up
|
|
§
Information Technology
|
|
|
|
Wholesaler Stocking
|
Percent of WAC
|
Angiomax and Angiomax NovaPlus
|
[**]%
|
Cleviprex
|
[**]%
|
Argatroban
|
[**]%
|
Recothrom
|
[**]%
|
|
|
Drop-Shipments / Direct Accounts
|
Percent of WAC
|
Angiomax and Angiomax NovaPlus
|
[**]%
|
Cleviprex
|
[**]%
|
Argatroban
|
[**]%
|
Recothrom
|
[**]%
|
**Direct to End-User Fee—Cleviprex Only
|
$[**] shipment
additional fee |
***Freight Upcharge (does not include Cleviprex
|
MDCO to reimburse Distributor for upgrade From Ground to Next Day Saver or Next Day Air
|
|
|
Generic Products
|
Percent of WAC
|
Fee for Service
|
[**]%
|
Prompt Pay Discount
|
[**]%
|
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 Second Amendment dated September 1, 2011, the Third Amendment dated April 23, 2012 and the Fourth Amendment dated April 29, 2013 (as amended, the “Agreement”);
|
B.
|
Under 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 12.1
. Section 12.1 of the Agreement is deleted in its entirety and replaced with the following:
|
12.1
|
Term
. This Agreement shall commence upon the Effective Date and will continue until February 28, 2014, unless sooner terminated in accordance with the terms of this Agreement. Thereafter, this Agreement shall automatically renew for subsequent terms of one additional year, unless either Party provides the other Party with written notice of its intent not to renew this Agreement at least 90 days before expiration of the current Term. The initial term and all renewal terms are collectively referred to as the “Term”.
|
3.
|
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.
|
THE MEDICINES COMPANY
|
||
By:
|
/s/ Stephen W. McKinnon
|
By:
|
/s/ Tanya Quinn
|
Name:
|
Stephen W. McKinnon
|
Name:
|
Tanya Quinn
|
Title:
|
SVP, GM
|
Title:
|
VP, Global Distribution &
Customer Service
|
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/ Clive A. Meanwell
|
|
|
|
Clive A. Meanwell
|
|
|
|
Chairman and Chief Executive Officer
|
Dated:
|
November 5, 2013
|
|
|
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
|
|
|
|
President and Chief Financial Officer
|
Dated:
|
November 5, 2013
|
|
|
(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 5, 2013
|
|
|
|
(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
|
|
|
|
|
President and Chief Financial Officer
|
Dated:
|
November 5, 2013
|
|
|
|