x
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the quarterly period ended March 31, 2011
|
|
OR
|
|
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
For the transition period from to
|
|
Commission File Number 000-50513
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Delaware
(State of Incorporation)
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13-3831168
(I.R.S. Employer
Identification Number)
|
Large accelerated filer x
|
Accelerated filer o
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Non-accelerated filer o
(Do not check if a
smaller reporting company)
|
Smaller Reporting Company o
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Class
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Outstanding at April 30, 2011
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Common Stock, $0.001 par value
per share
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39,461,985 shares
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PART I—FINANCIAL INFORMATION
|
Page | |
1 | ||
1 | ||
2 | ||
3 | ||
4 | ||
14 | ||
26 | ||
26 | ||
28 | ||
28 | ||
30 | ||
30 |
(In thousands, except share data)
|
March 31,
2011
|
December 31,
2010
|
(unaudited)
|
||
Assets
|
||
Current assets:
|
||
Cash and cash equivalents
|
$78,457
|
$34,641
|
Restricted cash
|
302
|
302
|
Short-term investments
|
146,890
|
205,389
|
Trade accounts receivable, net
|
23,795
|
22,272
|
Prepaid expenses
|
7,098
|
6,413
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Finished goods inventory held by the Company
|
42,595
|
36,232
|
Finished goods inventory held by others
|
2,200
|
2,186
|
Other current assets
|
4,343
|
3,734
|
Total current assets
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305,680
|
311,169
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Property and equipment, net of accumulated depreciation
|
3,594
|
3,203
|
Intangible assets, net of accumulated amortization
|
20,707
|
21,336
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Non-current portion of deferred cost of license revenue
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5,917
|
6,050
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Other assets
|
309
|
343
|
Total assets
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$336,207
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$342,101
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Liabilities and Stockholders’ Equity
|
||
Current liabilities:
|
||
Accounts payable
|
$19,184
|
$16,961
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Accrued expenses and other current liabilities
|
25,774
|
34,122
|
Deferred product revenue—Zanaflex tablets
|
9,694
|
9,526
|
Deferred product revenue—Zanaflex Capsules
|
21,242
|
21,770
|
Current portion of deferred license revenue
|
9,057
|
9,429
|
Current portion of revenue interest liability
|
1,979
|
1,297
|
Current portion of convertible notes payable
|
1,144
|
1,144
|
Total current liabilities
|
88,074
|
94,249
|
Non-current portion of deferred license revenue
|
84,535
|
86,429
|
Put/call liability
|
391
|
391
|
Non-current portion of revenue interest liability
|
3,329
|
3,586
|
Non-current portion of convertible notes payable
|
5,090
|
6,185
|
Commitments and contingencies
|
||
Stockholders’ equity:
|
||
Common stock, $0.001 par value. Authorized 80,000,000 shares at March 31, 2011 and December 31, 2010; issued and outstanding 38,808,217 and 38,779,370 shares as of March 31, 2011 and December 31, 2010, respectively
|
39
|
39
|
Treasury stock at cost (12,420 shares at March 31, 2011 and December 31, 2010)
|
(329)
|
(329)
|
Additional paid-in capital
|
595,796
|
591,650
|
Accumulated deficit
|
(440,758)
|
(440,086)
|
Accumulated other comprehensive income
|
40
|
(13)
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Total stockholders’ equity
|
154,788
|
151,261
|
Total liabilities and stockholders’ equity
|
$336,207
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$342,101
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(In thousands, except per share data)
|
Three-month
period ended
March 31,
2011
|
Three-month
period ended
March 31,
2010
|
Revenues:
|
||
Gross product sales
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$65,207
|
$17,254
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Less: discounts and allowances
|
(6,282)
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(1,864)
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Net sales
|
58,925
|
15,390
|
License and royalty revenue
|
2,361
|
2,357
|
Total net revenues
|
61,286
|
17,747
|
Costs and expenses:
|
||
Cost of sales
|
12,050
|
3,076
|
Research and development
|
10,708
|
8,062
|
Selling, general and administrative
|
38,087
|
26,714
|
Total operating expenses
|
60,845
|
37,852
|
Operating income (loss)
|
441
|
(20,105)
|
Other expense (net):
|
||
Interest and amortization of debt discount expense
|
(1,136)
|
(1,214)
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Interest income
|
140
|
204
|
Total other expense (net)
|
(996)
|
(1,010)
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Loss before taxes
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(555)
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(21,115)
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Provision for income taxes
|
(117)
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—
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Net loss
|
$(672)
|
$(21,115)
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Net loss per share—basic
|
$(0.02)
|
$(0.56)
|
Net loss per share—diluted
|
$(0.02)
|
$(0.56)
|
Weighted average common shares outstanding used in computing net loss per share—basic
|
38,781
|
38,021
|
Weighted average common shares outstanding used in computing net loss per share—diluted
|
38,781
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38,021
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(In thousands)
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Three-month
period ended
March 31,
2011
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Three-month
period ended
March 31,
2010
|
Cash flows from operating activities:
|
||
Net loss
|
$(672)
|
$(21,115)
|
Adjustments to reconcile net loss to net cash provided by operating activities:
|
||
Share-based compensation expense
|
3,755
|
3,186
|
Amortization of net premiums and discounts on short-term investments
|
1,863
|
1,219
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Amortization of revenue interest issuance cost
|
36
|
30
|
Depreciation and amortization expense
|
1,139
|
838
|
Changes in assets and liabilities:
|
||
Increase in accounts receivable
|
(1,523)
|
(2,205)
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Increase in prepaid expenses and other current assets
|
(1,294)
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(2,291)
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Increase in inventory held by the Company
|
(6,363)
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(16,808)
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(Increase) decrease in inventory held by others
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(14)
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88
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Decrease in non-current portion of deferred cost of license revenue
|
133
|
165
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(Decrease) increase in accounts payable, accrued expenses, other current liabilities
|
(7,216)
|
15,605
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Increase in revenue interest liability interest payable
|
659
|
615
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Decrease in current portion of deferred license revenue
|
(371)
|
—
|
Decrease in non-current portion of deferred license revenue
|
(1,893)
|
(2,357)
|
Increase (decrease) in deferred product revenue—Zanaflex tablets
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168
|
(457)
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Decrease in deferred product revenue—Zanaflex Capsules
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(529)
|
(540)
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Net cash used in operating activities
|
(12,122)
|
(24,027)
|
Cash flows from investing activities:
|
||
Purchases of property and equipment
|
(743)
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(456)
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Purchases of intangible assets
|
(164)
|
(6,612)
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Purchases of short-term investments
|
(42,812)
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(31,113)
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Proceeds from maturities of short-term investments
|
99,500
|
96,750
|
Net cash provided by investing activities
|
55,781
|
58,569
|
Cash flows from financing activities:
|
||
Proceeds from issuance of common stock and option exercises
|
392
|
4,108
|
Repayments of revenue interest liability
|
(235)
|
(232)
|
Net cash provided by financing activities
|
157
|
3,876
|
Net increase in cash and cash equivalents
|
43,816
|
38,418
|
Cash and cash equivalents at beginning of period
|
34,641
|
47,314
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Cash and cash equivalents at end of period
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$78,457
|
$85,732
|
Supplemental disclosure:
|
||
Cash paid for interest
|
429
|
541
|
For the three-month
|
|||||||
period ended March 31,
|
|||||||
(In thousands)
|
2011
|
2010
|
|||||
Research and development
|
$
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1,103
|
$
|
790
|
|||
Selling, general and administrative
|
2,652
|
2,396
|
|||||
Total
|
$
|
3,755
|
$
|
3,186
|
Number of Shares
(In thousands)
|
Weighted Average
Exercise Price
|
Weighted Average
Remaining
Contractual
Term
|
Intrinsic Value
(In thousands)
|
|
Balance at January 1, 2011
|
4,084
|
$20.13
|
||
Granted
|
904
|
22.38
|
||
Cancelled
|
(33)
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24.58
|
||
Exercised
|
(29)
|
13.59
|
||
Balance at March 31, 2011
|
4,926
|
$20.55
|
7.3
|
$24,415
|
Vested and expected to vest at March 31, 2011
|
4,786
|
$20.40
|
7.2
|
$24,306
|
Vested and exercisable at March 31, 2011
|
2,669
|
$16.01
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5.8
|
$22,345
|
(In thousands)
Restricted Stock
|
Number of Shares
|
Nonvested at January 1, 2011
|
323
|
Granted
|
277
|
Vested
|
—
|
Forfeited
|
(3)
|
Nonvested at March 31, 2011
|
597
|
(In thousands, except per share data)
|
Three-month
period ended
March 31,
2011
|
Three-month
period ended
March 31,
2010
|
Basic and diluted
|
||
Net loss
|
$(672)
|
$(21,115)
|
Weighted average common shares outstanding used in computing net loss per share—basic
|
38,781
|
38,021
|
Plus: net effect of dilutive stock options and restricted common shares
|
—
|
—
|
Weighted average common shares outstanding used in computing net loss per share—diluted
|
38,781
|
38,021
|
Net loss per share—basic
|
$(0.02)
|
$(0.56)
|
Net loss per share—diluted
|
$(0.02)
|
$(0.56)
|
(In thousands)
|
Level 1
|
Level 2
|
Level 3
|
Assets Carried at Fair Value:
|
|||
Cash equivalents
|
$78,457
|
$—
|
$—
|
Short-term investments
|
146,890
|
—
|
—
|
Liabilities Carried at Fair Value:
|
|||
Put/call liability
|
—
|
—
|
391
|
(In thousands)
|
Balance as of
December 31, 2010
|
Realized (gains)
losses included
in net loss
|
Unrealized
(gains) losses included
in other
comprehensive
loss
|
Balance as of
March 31, 2011
|
Liabilities Carried at Fair Value:
|
||||
Put/call liability
|
$391
|
($—)
|
$—
|
$391
|
(In thousands)
|
Amortized
Cost
|
Gross
unrealized
gains
|
Gross
unrealized
losses
|
Estimated
fair
value
|
March 31, 2011
|
||||
US Treasury bonds
|
$146,850
|
$40
|
$—
|
$146,890
|
December 31, 2010
|
||||
US Treasury bonds
|
205,401
|
5
|
(18)
|
205,388
|
(In thousands)
|
March 31, 2011
|
December 31, 2010
|
Estimated
remaining
useful lives as of
March 31, 2011
|
Zanaflex Capsule patents
|
$19,350
|
$19,350
|
11 years
|
Zanaflex trade name
|
2,150
|
2,150
|
0 years
|
Ampyra milestones
|
3,250
|
3,250
|
6 years (1)
|
CSRO royalty buyout
|
3,000
|
3,000
|
6 years (1)
|
Website development costs
|
2,983
|
2,975
|
0-3 years
|
Website development costs-in process
|
157
|
—
|
0-3 years
|
30,890
|
30,725
|
||
Less accumulated amortization
|
10,183
|
9,389
|
|
$20,707
|
$21,336
|
2011
|
$3,184
|
2012
|
2,871
|
2013
|
2,532
|
2014
|
2,183
|
2015
|
2,183
|
$12,953
|
|
•
|
with respect to Zanaflex net revenues up to and including $30.0 million for each fiscal year during the term of the agreement, 15% of such net revenues;
|
|
•
|
with respect to Zanaflex net revenues in excess of $30.0 million but less than and including $60.0 million for each fiscal year during the term of the agreement, 6% of such net revenues; and
|
|
•
|
with respect to Zanaflex net revenues in excess of $60.0 million for each fiscal year during the term of the agreement, 1% of such net revenues.
|
Assumption
|
Method of estimating
|
•Estimated expected term of options
|
•Historical term data
|
•Expected volatility
|
•Combination of historic volatility of our common stock since October 1, 2006 and the historic volatility of the stock of our peer companies
|
•Risk-free interest rate
|
•Yields of U.S. Treasury securities corresponding with the expected life of option grants
|
•Forfeiture rates
|
•Historical forfeiture data
|
10.14*
|
Amended and Restated License Agreement, dated September 26, 2003, by and between the Registrant and Elan Corporation, plc.
|
10.41*
|
License Agreement, dated as of December 19, 2003, by and among the Registrant, Cambridge University Technical Services Limited, and King’s College London.
|
10.59*
|
Development and Supplemental Agreement between Elan Pharma International Limited and the Registrant dated January 14, 2011.
|
10.60*
|
Amendment #1 to License Agreement among the Registrant, Cambridge Enterprise Limited (formerly Cambridge University Technical Services Limited), and Kings College London dated as of March 4, 2011.
|
31.1
|
Certification by the Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
|
31.2
|
Certification by the Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
|
32.1
|
Certification by the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
32.2
|
Certification by the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
101.INS**
|
XBRL Instance Document
|
101.SCH**
|
XBRL Taxonomy Extension Schema Document
|
101.CAL**
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.LAB**
|
XBRL Taxonomy Extension Label Linkbase Document
|
101.PRE**
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
Acorda Therapeutics, Inc.
|
||
By:
|
/s/ Ron Cohen
|
|
Date: May 9, 2011
|
Ron Cohen, M.D.
President, Chief Executive Officer and Director
(Principal Executive Officer)
|
By:
|
/s/ David Lawrence
|
|
Date: May 9, 2011
|
David Lawrence, M.B.A.
Chief Financial Officer
(Principal Financial and Accounting Officer)
|
Exhibit No.
|
Description
|
10.14*
|
Amended and Restated License Agreement, dated September 26, 2003, by and between the Registrant and Elan Corporation, plc.
|
10.41*
|
License Agreement, dated as of December 19, 2003, by and among the Registrant, Cambridge University Technical Services Limited, and King’s College London.
|
10.59*
|
Development and Supplemental Agreement between Elan Pharma International Limited and the Registrant dated January 14, 2011.
|
10.60*
|
Amendment #1 to License Agreement among the Registrant, Cambridge Enterprise Limited (formerly Cambridge University Technical Services Limited), and Kings College London
dated as of March 4, 2011.
|
31.1
|
Certification by the Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
|
31.2
|
Certification by the Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934.
|
32.1
|
Certification by the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
32.2
|
Certification by the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
101.INS**
|
XBRL Instance Document
|
101.SCH**
|
XBRL Taxonomy Extension Schema Document
|
101.CAL**
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.LAB**
|
XBRL Taxonomy Extension Label Linkbase Document
|
101.PRE**
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
DEFINITIONS AND INTERPRETATION
|
|
ARTICLE 2
|
THE LICENSE
|
ARTICLE 3
|
DEVELOPMENT OF THE PRODUCT
|
ARTICLE 4
|
[NOT USED]
|
ARTICLE 5
|
FINANCIAL PROVISIONS
|
ARTICLE 6
|
REGISTRATION OF THE PRODUCT
|
ARTICLE 7
|
[NOT USED]
|
ARTICLE 8
|
WARRANTY AND INDEMNITY
|
ARTICLE 9
|
[NOT USED]
|
ARTICLE 10
|
COMMITTEE
|
ARTICLE 11
|
PATENTS
|
ARTICLE 12
|
SUNDRY CLAUSES
|
SCHEDULE 1
|
ACORDA PATENT RIGHTS
|
SCHEDULE 2
|
ASSIGNMENT AGREEMENT
|
SCHEDULE 3
|
ELAN PATENT RIGHTS
|
SCHEDULE 4
|
NDA TIMELINE
|
SCHEDULE 5
|
RUSH/ACORDA LICENSE
|
SCHEDULE 6
|
RUSH PAYMENTS AGREEMENT
|
SCHEDULE 7
|
SPECIFICATIONS
|
SCHEDULE 8
|
SUPPLY AGREEMENT
|
SCHEDULE 9
|
TECHNOLOGY TRANSFER RESPONSIBILITES
|
(1)
|
Elan Corporation, plc., a public limited company incorporated under the laws of Ireland, and having its registered office at Lincoln House, Lincoln Place, Dublin 2, Ireland (“Elan”); and
|
|
|
(2)
|
Acorda Therapeutics, Inc., a corporation organized under the laws of the State of Delaware and having its principal office at 15 Skyline Drive, Hawthorne, New York 10532, United States of America (“Acorda”).
|
|
|
(A)
|
As of April 21, 1998, Elan and Acorda entered into an amended and restated licence and supply agreement relating to SCI (effective as from January 23, 1997) (the “SCI Agreement”);
|
|
|
(B)
|
Effective as of April 21, 1998, Elan, Acorda and MS R & D entered into a licence and supply agreement relating to MS (the “MS Agreement”);
|
|
|
(C)
|
Pursuant to the Assignment Agreement (i) MS R & D assigned all of its rights, title, interest and obligations under the MS Agreement to Acorda, and Acorda assumed all of MS R & D’s obligations thereunder; and (ii) Elan, Acorda and MS R & D terminated the MS R & D Agreements (as defined in the Assignment Agreement)
|
|
|
(D)
|
The Parties desire and agree that certain provisions of the SCI Agreement and the MS Agreement should be amended, clarified and restated to reflect the intentions of the Parties with respect to the development, manufacturing and marketing of the Product in the Territory for the Indications on the terms and conditions set out herein.
|
|
|
1.1.
|
In the present Agreement and any further agreements based thereon between the Parties hereto, the following definitions shall prevail:
|
|
(a)
|
any and all know how as of the Amendment Date pertaining to the development or manufacture of transdermal formulations of the Compound and/or other mono- or di-aminopyridines, isomers and salts thereof, other than US patents numbers 5,370,879, 5,540,938 and/or 5,580,580, and any foreign equivalents, divisionals, reissues or continuations and any patents issued thereon, and the know-how described therein; and
|
|
|
|
(b)
|
nanoformulation technology to the extent specifically licensed by Elan to Merck pursuant to the Merck Agreement for Indications other than MS or SCI.
|
|
|
|
(a)
|
for (i) the Launch Year and (ii) if no Statement is due to be produced prior to ninety (90) days prior to the estimated date of First Commercial Sale in such country, the Notional NSP shall be estimated in good faith; and
|
|
|
|
(b)
|
in each subsequent year, Notional NSP shall be calculated by reference to the average NSP in that country as evidenced by the last four Statements (or such lesser number of Statements as have actually been produced in relation to that country).
|
|
|
|
(a)
|
transportation charges or allowances, including freight pick-up allowances, and packaging costs, if any;
|
|
(b)
|
trade, quantity or cash discounts, service allowances and independent broker’s or agent’s commissions, if any, allowed or paid;
|
|
|
|
(c)
|
credits or allowances, if any, given or made on account of price adjustments, returns up to ten per cent (10%) of gross sales, off-invoice promotional discounts, rebates, any and all national, federal, state or local government rebates, whether in existence now, or enacted at any time during the term of this Agreement, rejections, recall or Product destruction (voluntarily made or requested or made by an appropriate government agency sub-division or department) for the Product; and
|
|
|
|
(d)
|
any duty, tariff or tax (other than income or corporation tax), excise or governmental charge upon or measured by the production, import, export, sale, transportation, delivery, or use of the Product.
|
|
|
1.2.
|
In this Agreement
|
|
|
|
1.2.1
|
the singular includes the plural and vice versa, the masculine includes the feminine and vice versa and references to natural persons include corporate bodies, partnerships and vice versa;
|
|
|
|
1.2.2
|
any reference to an Article, Exhibit or Schedule shall, unless otherwise specifically provided, be to an Article, Exhibit or Schedule of this Agreement;
|
|
1.2.3
|
the headings of this Agreement are for ease of reference only and shall not affect its construction or interpretation; and
|
|
1.2.4
|
the expressions “include”, “includes”, “including”, “in particular” and similar expressions shall be construed without limitation.
|
2.1.
|
License Grant:
|
|
|
|
2.1.1
|
the Fampridine Product in the SCI Field for the SCI Term;
|
|
|
|
2.1.2
|
the Fampridine Product in the MS Field for the MS Term; and
|
|
|
|
2.1.3
|
without prejudice to Articles 2.1.1 and 2.1.2, the Product in the SCI Field, MS Field and/or Other Indication Field for the Other Indication Term, subject to any contractual obligations of Elan under the Merck Agreement with respect to a formulation using Nanoformulation technology (as defined in the Merck Agreement) in the Other Indication Field.
|
|
|
2.2.
|
Acceptance; Acorda Non-Competition:
|
|
|
2.3.
|
Sub-licensing:
|
|
|
|
2.3.1
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Acorda may sub-license or otherwise authorise one or more third parties (each a Designee) to use, import, offer for sale, promote, distribute, sell and otherwise exploit the Product in one or more countries of the Territory (but not the rights to manufacture the Product which may only be sub-licensed in accordance with the provisions of the Supply Agreement). In circumstances where the third party is entitled to, or is likely to be able to obtain, access to the CMC Section, the prior written consent of Elan shall be obtained to any sub-licence or other agreement permitted by this Article 2.3.1 which consent shall not be unreasonably withheld or delayed. In the event that the Third Party is entitled to access to Confidential Information disclosed by Elan to Acorda, the agreement between the Third Party and Acorda shall contain obligations of confidentiality no less onerous than those set out in this Agreement. Elan shall be furnished with a copy of the proposed and the executed sub-licence or other agreement contemplated by this Article 2.3.1 Any sub-licence or other agreement permitted by this Article 2.3.1 shall be subject to the terms of this Agreement, but excluding the right to grant a sub-licence. Acorda shall use its reasonable endeavours to ensure that Elan shall have the same rights of audit and inspection vis a vis a Designee, as Elan has pursuant to this Agreement concerning Acorda. A sub-licence may be granted by Acorda without any obligation upon the Designee to pay to Acorda or Elan any amounts other than those set out in this Agreement.
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2.3.2
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Insofar as the obligations owed by Acorda to Elan are concerned, Acorda shall remain responsible for all acts and omissions of any Designee as if such acts and omissions were by Acorda. Any sub-licence or other agreement permitted by Article 2.3.1 shall automatically and immediately terminate on termination of this Agreement.
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2.3.3
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For the avoidance of doubt, the Parties hereby confirm that In Market sales of the Product by any Designee shall constitute sales by Acorda for the purposes of Article 5.6.
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2.4.
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Use of Data and Improvements:
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2.5.
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Rush:
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2.6.
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Technical Advice:
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2.7.
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Combination Products:
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2.8.
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Elan Competing Product:
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2.8.1
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the indication of SCI; and/or
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2.8.2
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the indication of MS; and/or
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2.8.3
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any other Indications, subject, during the term of the Merck Agreement, to any contractual obligations of Elan under the Merck Agreement with respect to a formulation using Nanoformulation technology (as defined in the Merck Agreement).
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2.9.
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Trademark:
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2.9.1
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Acorda shall market the Product in the Territory under a Trademark, whether during the Initial Period or thereafter, which Trademark will be owned by Acorda.
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2.9.2
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Elan grants to Acorda a non-exclusive royalty free licence in the Territory solely for use in connection with the sale of the Product, for the term of this Agreement to use any trademark which relates to the Elan technology applicable to the Product (“Elan Trademark”), such as an acronym for the applicable technology applied to the Product, on the following terms:
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2.9.2.1
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Acorda shall as soon as it becomes aware of any infringement give to Elan in writing full particulars of any use or proposed use by any other person, firm or company of a trade name or trademark or mode
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2.9.2.2
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If Acorda becomes aware that any other person, firm or company alleges that the Elan Trademark is invalid or that the use of the Elan Trademark infringes any rights of another party or that the Elan Trademark is otherwise attacked or attackable, Acorda shall immediately give to Elan full particulars in writing thereof and shall make no comment or admission to any Third Party in respect thereof.
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2.9.2.3
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Elan shall have the right to conduct all proceedings relating to the Elan Trademark and shall in its sole discretion decide what action, if any, to take in respect of any infringement or alleged infringement of the Elan Trademark or passing-off or any other claim or counter-claim brought or threatened in respect of the use or registration of the Elan Trademark. Any such proceedings shall be conducted at Elan’s expense and for its own benefit.
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2.9.2.4
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At no time during or after the term of this Agreement shall Acorda challenge or assist others to challenge the Elan Trademark, or the registration thereof or attempt to register any trademarks, marks, or trade names confusingly similar to the Elan Trademark.
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2.9.3
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Acorda shall not be obliged to use the Elan Trademark to identify the Product but at Elan’s request shall be obliged to use the Elan Trademark to identify the applicable Elan technology embodied in the Product. For the avoidance of doubt, the Parties hereby confirm that Acorda shall not be entitled to a licence to use any trademark owned or controlled by Elan which identifies a product, including Neurelan®.
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2.10.
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When packaged, and to the extent permitted by law, a product label shall include an acknowledgement that the Product is made under licence from or, if applicable, manufactured by Elan. Such acknowledgement shall take into consideration regulatory requirements and Acorda’s commercial requirements, including any requirement to state that Product is mananufactured by Patheon. Acorda shall wherever possible give due acknowledgement and recognition to Elan in all printed promotional and other material regarding the Product such as stating that the Product is under licence from, or if applicable, manufactured by, Elan. Acorda shall consult with and obtain the approval of Elan as to the format and content of the promotional and other material insofar as it relates to a description of, or other reference to, the application of the Elan Intellectual Property. It shall be presumed that Elan approved of such use unless Elan provides written notice of disapproval of such use to Acorda within thirty (30) days of delivery of such materials to Elan, such approval not to be unreasonably withheld. The further consent of Elan shall not be required where the format and content of such materials is
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2.11.
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Diligence:
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2.11.1
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Acorda shall use reasonable efforts consistent with the reasonable standard as would be applied by a bio-pharmaceutical company of similar size, stage of development and assets for a product of the market size and potential of the Product to market and promote the Product throughout the Territory.
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2.11.2
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Acorda shall effect a national commercial launch of the Product in the United States of America within one hundred and eighty (180) days of NDA Approval, provided that Acorda shall have received the agreed quantities of Launch Stocks ordered pursuant to firm purchase orders at least sixty (60) days in advance of the launch date. It is agreed that with respect to Japan and the Major European Markets, Acorda will effect a national commercial launch of the Product within one hundred and eighty (180) days after the necessary Regulatory Approvals, provided that Acorda shall have received the agreed quantities of Launch Stocks ordered pursuant to firm purchase orders pursuant to the Supply Agreement at least sixty (60) days in advance of the projected launch date. In the event that Acorda shall have received the agreed quantities of Launch Stocks ordered pursuant to firm purchase orders pursuant to the Supply Agreement at least sixty (60) days in advance of the projected launch date and Acorda does not make a national commercial launch in one or more of the countries listed above within the one hundred and eighty (180) day period, or such longer period permitted by the provisions of this Article 2.11.2, the licences granted to Acorda hereunder shall with thirty (30) days notice from Elan terminate in the applicable country and Elan shall be entitled to a licence to the Acorda Patent Rights and the Acorda Know-How in the applicable country on the terms set out in Article 2.11.3 and to the Trademark on the terms set out in Article 2.9. Notwithstanding the above, in the event that the Parties disagree whether or not Acorda has satisfied its obligations under this Agreement in any country listed above, the matter may be submitted to arbitration by either Party, and Acorda’s rights and licences shall remain in effect until and unless the arbitrator makes a decision that Acorda’s right and licence in such country should terminate.
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2.11.3
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Acorda will use commercially reasonable efforts to file and obtain registration approval in the United States of America, the Major European Markets and Japan as soon as practicable. In the event of any failure by Elan to perform its obligations under this Agreement or under the Supply Agreement which results in Acorda’s failure to obtain such a Regulatory Approval or any delay thereof, the Parties through the Committee shall make reasonable and appropriate adjustments to the period in which Acorda shall have to file to obtain the applicable Regulatory Approval. If (x) Acorda fails to file to obtain a Regulatory Approval to commercialise the Product in the United States of America, Japan or the Major European Markets within a commercially reasonable time after completion and receipt of positive data from all pre-
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2.11.4
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2.11.4.1
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Acorda will use its commercially reasonable efforts to obtain Regulatory Approval to commercialise the Product in the other countries of the Territory that it selects, having regard to the effort and expenditure required to obtain Regulatory Approval for the Product and the commercial opportunities for the Product in such other countries of the Territory.
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2.11.4.2
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In the event that the Parties disagree whether Acorda has satisfied its obligations under Article 2.11.4.1, with regard to one or more of such other countries of the Territory, the matter may be submitted to the Committee, and if not resolved by the Committee, by arbitration, by either Party, and Acorda’s rights and licences shall remain in effect until and unless the arbitrator makes a decision that Acorda’s right and licence hereunder in such country should terminate.
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2.11.4.3
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If Acorda (a) indicates to Elan that it does not intend to file to obtain Regulatory Approval and commercialise the Product in a particular country or countries of the Territory, or (b) fails to commence commercialisation in any country in the Territory (other than the United States, the Major European Markets {or, if
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3.1.
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Subject to the provisions of this Article 3, Acorda shall use its reasonable efforts, as would be deemed commensurate with the achievement of its own business aims for a similar product of its own to conduct such part of the Project as the Parties mutually agree shall be conducted by Acorda. Subject to the provisions of this Article 3, Elan shall use its reasonable efforts, as would be deemed commensurate with the achievement of its own business aims for a similar product of its own, to conduct such part of the Project as the Parties mutually agree that shall be conducted by Elan. The allocation between the Parties of their respective responsibilities for conducting parts of the Project (i) is set forth in Schedule 9 - Technology Transfer Responsibilities, and (ii) shall be set forth in a development plan (the “Development Plan”) to be prepared and updated from time to time by Acorda in consultation with Elan, relating to the development of the Product, the current form of which is attached as Schedule 4 - NDA Timeline, and the Committee shall monitor the progress of such activities. Elan and Acorda each undertake that it shall carry out the respective studies, testing and activities set forth as Technology Transfer Responsibilities, in the Development Plan, and otherwise undertaken and conducted by it in good faith and in accordance with prevailing cGCP and cGLP and FDA standards and guidelines.
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3.2.
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Provided that Elan uses reasonable endeavours to meet its obligations under this Agreement, Elan shall have no liability to Acorda as a result of any failure or delay of the Product to achieve one or more of the milestones set out in the Project and/or to obtain the NDA Approval or the approval of the regulatory authorities in one or more of the other countries of the Territory. Acorda shall have no liability to Elan as a result of any failure or delay of the Product to obtain the NDA Approval or the approval of the appropriate health regulatory authorities in one or more of the countries of the Territory.
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3.3.
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The Parties hereby confirm that each shall undertake its respective part of the Project as a collaborative effort and that the provisions of this Agreement requires that each Party diligently carries out those tasks assigned to it under the Project and as otherwise agreed during the course of the Project. Each Party shall co-operate with the other in good faith particularly with respect to unknown problems or contingencies and shall perform its
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3.4.
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Elan will supply Acorda with Acorda’s reasonable requirements of Product including clinical trial supplies to enable Acorda to carry out the Project. The Product shall be supplied by Elan EXW at Manufacturing Cost.
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3.5.
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Acorda agrees to carry out and complete the Phase III programme in the United States of America to a standard and timeframe that a company of comparable size, stage of development and assets would use for a product of similar size and potential as the Product.
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3.6.
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With respect to generating stability data on the oral Product in bulk tablet form, Elan and Acorda acknowledge and agree that (i) under the SCI Agreement and the MS Agreement, Elan had the responsibility for generating such data, (ii) pursuant to the Cardinal Agreement, Cardinal is currently performing such stability testing, (iii) the Technology Transfer Responsibilities shall govern the related responsibilities of the Parties, provided that the data resulting from such stability testing shall be provided to both Acorda and Elan, and Elan shall have the right to and responsibility for providing necessary and appropriate technical assistance and oversight of such stability testing (including having the right at its own expense to arrange for its employees involved in the Project to discuss the stability testing and its results with the technical personnel of Acorda and Cardinal upon reasonable notice and at reasonable times); and (iv) Elan shall incorporate such stability data into the CMC module that it will prepare for delivery to Acorda for inclusion in the NDA or any NDA Equivalent, pursuant to Article 3.8.
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3.7.
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For the avoidance of doubt, the Parties hereby confirm that a primary objective of the Project is to generate the NDA and secure NDA Approval for the oral Product. As of the date of the SCI Agreement, the MS Agreement and the Amendment Date, it is the Parties’ expectation that the body of data so generated in the Project will also support such applications for Regulatory Approval that Acorda shall make in the other countries of the Territory. In the event however that such expectation proves unfounded or incorrect and further data is required to obtain such other approvals as are pursued by Acorda in the other countries of the Territory, Acorda shall determine the viability of proceeding further with the regulatory application and generation of the further data requirements. In the event that Acorda elects to continue, the Parties shall update the Development Plan to reflect the allocation between the Parties of conducting such additional activities. In such event, subject to and in accordance with the provisions of this Article 3, Elan shall be responsible for conducting such further activities and generating such further data as set forth in the Development Plan to allow Acorda to seek such further Regulatory Approvals in the Territory. Notwithstanding the foregoing, it is intended by the Parties that except as otherwise specifically set forth in a Development Plan agreed to by the Parties and subject to compliance with regulatory requirements, Acorda shall have primary responsibility and decision making authority with respect to development and marketing of Product.
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3.8.
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Elan shall be responsible for the preparation and delivery to Acorda of the CMC Section in electronic and hard copy form and the latter in format suitable for inclusion in the NDA and any NDA Equivalent in accordance with applicable law and regulatory standards and as the Parties may mutually agree. Acorda shall provide Elan as soon as practicable with a copy of any comments received by Acorda from the FDA or any other regulatory authority relating to the CMC Section and Elan shall provide or, at Acorda’s request, cooperate with Acorda to provide, a response to such comments as soon as practicable. In the event that there is a deficiency in the CMC Section attributable to negligence by Elan in the activities conducted by Elan, then Elan shall be responsible for correcting such deficiency, at Elan’s expense, and shall use reasonable efforts to do so as soon as practicable. In the event Elan breaches the foregoing obligation, in addition to any other remedies available to Acorda, Acorda shall have the right to correct such deficiency or arrange to have a Third Party conduct any required activities necessary to correct such deficiency, at Elan’s expense, the cost of which may be offset against any amounts otherwise due Elan under this Agreement. Acorda shall be responsible for the maintenance of the CMC Section in accordance with applicable law and regulatory standards, at Acorda’s expense, provided that (i) Elan shall cooperate with and provide reasonable assistance to Acorda in connection with such maintenance; and (ii) any revisions, amendments or supplements to the CMC Section required by or resulting from the negligence of Elan in performing its obligations hereunder or under the Supply Agreement, or from any action taken by Elan on its own initiative, or taken by Acorda or any Acorda Designee on behalf of or at the request of Elan, including any changes made by Elan on its own initiative to its manufacturing processes or facilities, shall be at Elan’s expense; and (iii) Elan shall not make any changes to its manufacturing processes or facilities that would require an amendment or supplement to the CMC Section without first notifying Acorda of such changes and preparing and delivering to Acorda any required amendments or supplements to the CMC Section before the implementation of such changes.
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5.1.
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Research and Development Activities:
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5.1.1
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In consideration for the research and development of the Product by Elan under this Agreement, Acorda shall pay to Elan the amounts set out in Article 5.1.2.
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5.1.2
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Research and Development Cost incurred by Elan after the Amendment Date and before commercial launch of the Product shall be invoiced and payable monthly, at a rate of FTE plus [***].
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5.1.3
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Elan will keep accurate records consistent with its normal business practices, of the efforts expended by it under the Project for which it is charging Acorda, which will include the time spent by each person working on the Project. Each quarter Elan will send reports to Acorda in order to enable Acorda to monitor Elan’s level of effort to assure Acorda that the committed level of effort is being applied.
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5.1.4
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If Elan’s development efforts require the use of a Third Party, Elan will, prior to appointing such Third Party, discuss with Acorda the activities to be undertaken by such Third Party and the terms and conditions thereof. Elan will not proceed with such Third Party without the prior written approval of Acorda, which approval shall not be unreasonably withheld. Elan shall charge Acorda for the time spent by its employees in administering the work conducted by such Third Parties on the basis set out in Article 5.1.2. Elan shall have the right to charge Acorda for all reasonable out of pocket expenses incurred in the provision of its obligations thereunder.
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5.2.
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License Royalties:
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5.2.1
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In consideration of the rights and licence granted to Acorda to the Elan Patent Rights by virtue of the SCI Agreement, Acorda has paid to Elan $5,000,000 (five million United States Dollars); and
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5.2.2
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In consideration of the rights and licence granted to MS R & D to the Elan Patent Rights by virtue of the MS Agreement, MS R & D has paid to Elan $15,000,000 (fifteen million United States Dollars) –
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5.3.
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Milestone Payments:
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5.3.1
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In further consideration of the rights and license granted to Acorda to the Elan Patent Rights hereunder, Acorda shall pay to Elan the following non-refundable amounts contingent upon occurrence of the specified event, with each milestone payment to be made no more than once with respect to the achievement of such event (but payable the first time such milestone is achieved) for Product:
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5.3.1.1
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US$2,500,000 (two million five hundred thousand dollars) 90 (ninety) days after written receipt of NDA Approval of the Product for the first Indication;
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5.3.1.2
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US$2,500,000 (two million five hundred thousand dollars) on the earlier of (a) 90 (ninety) days after written receipt of NDA Approval of the Product for a second Indication or (b) the 2nd (second) anniversary of NDA Approval of the Product for the first Indication;
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5.3.1.3
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US$1,000,000 (one million dollars) upon the commencement of a Phase III Clinical Study of the Product for a third Indication;
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5.3.1.4
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US$1,000,000 (one million dollars) upon acceptance by the FDA for filing of the NDA for a third Indication;
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5.3.1.5
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US$1,500,000 (one million five hundred thousand dollars) upon written receipt of NDA Approval of the Product for a third Indication;
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5.3.1.6
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US$1,500,000 (one million five hundred thousand dollars) upon First Commercial Sale of the Product for a third Indication;
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5.3.1.7
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US$1,000,000 (one million dollars) upon the commencement of a Phase III Clinical Study of the Product for a fourth Indication;
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5.3.1.8
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US$1,000,000 (one million dollars) upon acceptance by the FDA for filing of the NDA for a fourth Indication;
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5.3.1.9
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US$1,500,000 (one million five hundred thousand dollars) upon written receipt of NDA Approval of the Product for a fourth Indication; and
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5.3.1.10
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US$1,500,000 (one million five hundred thousand dollars) upon First Commercial Sale of the Product for a fourth Indication –
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5.3.2
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The Milestone Payments referred to in Articles 5.3.1.3 through 5.3.1.10 shall be payable within forty five (45) days after achievement of the applicable milestone event.
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5.3.3
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For the avoidance of doubt, references in this Article 5.3 to an Indication by number are to the number of Indications for which a particular milestone has been achieved.
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5.3.4
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In respect of each of the third and fourth indication of the Product, in the event that Acorda spends in excess of [***] on Phase III Clinical Studies for such indication, Acorda shall be entitled to credit one half of the excess spend in respect of that indication, over and above [***] per indication, against the respective Milestone Payments for that indication, viz. the Milestone Payments referred to in Articles 5.3.1.4 and 5.3.1.5 for the third indication and the Milestone Payments referred to in Articles 5.3.1.8 and 5.3.1.9 for the fourth indication, up to a maximum of [****] for each indication.
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5.3.5
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The Milestone Payments shall not be subject to future performance obligations of Elan to Acorda and shall not be applicable against future services provided by Elan to Acorda.
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5.4.
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Certain Payments relating to Rush/Acorda License:
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5.5.
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License Revenues:
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5.6.
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Royalty on Sales:
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5.6.1
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Subject to Article 5.6.2 and in further consideration of the rights and license granted to Acorda to the Elan Patent Rights while there is a Valid Claim thereunder, and in consideration of the rights and license granted to Acorda of the Elan Know-How thereafter, Acorda shall additionally pay to Elan a royalty of [***] of the NSP of the Product (the “Elan Royalty”). The Elan Royalty shall be payable as follows:
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5.6.1.1
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In respect of the Elan Royalty, where Elan manufactures and supplies the Product, Elan shall render an invoice in respect of the quantities of Product delivered to Acorda for a sum calculated by reference to [***] of the Notional NSP and the quantity of Product supplied. For the avoidance of doubt the Parties agree that if for whatever reason the Product supplied by Elan to Acorda which meets the Specifications and the applicable law and regulatory
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5.6.1.2
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Within forty five (45) days of the end of each calendar quarter, Acorda shall notify Elan of the prevailing NSP for Product sold in the previous quarter. Acorda shall calculate the total Elan Royalty payable to Elan for the Product supplied by Elan during the previous quarter by reference to [***] of the NSP. The Parties shall adjust their account by Acorda promptly paying to Elan, or by Elan crediting Acorda against the price of Product to be supplied (as the case may be), the difference between the sum paid pursuant to Article 5.6.1.1 and the sum calculated pursuant to this Article 5.6.1.2.
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5.6.1.3
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In respect of the Elan Royalty, where Elan does not manufacture and supply the Product, within forty five (45) days of the end of each calendar quarter (for the first two years following first commercial sale of the Product in any country of the Territory, within sixty (60) days of the end of each quarter), Acorda shall notify Elan of the prevailing NSP of Product sold in that preceding quarter and of the quantity of Product sourced from third parties. The Elan Royalty in respect of such Product shall each be payable on the date on the date such report is due.
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5.6.2
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In countries where there are no Valid Claims covering the Product and if there is no Competition, Acorda shall pay to Elan the applicable Elan Royalty set forth in Article 5.6.1 for sales in such countries; provided, if, and only if, (a) Elan is not manufacturing the Product, (b) there are no Valid Claims covering the Product and (c) there is Competition in any such country, the Elan Royalty due under Article 5.6.1 on Product sales in such country shall be reduced to [***] of NSP provided, however, that in the event there is Competition in any country, the Parties agree to discuss, considering market conditions, further reducing the Elan Royalty.
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5.6.3
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In the event that Elan or its subcontractor does not manufacture and supply the Product and in the event that Acorda enters into a licence agreement with any Third Party with respect to a Dominating Patent, or to avoid or settle a claim by a Third Party for infringement or misappropriation by any Elan Intellectual Property right relating to the manufacture, use or sale of the Product, Acorda may offset any payments made in accordance with such licence agreements against any royalty amounts (and not amounts in respect of manufacturing) owed by Acorda to Elan, up to a maximum of [***] of the royalty amounts due. For the purpose of this Article 5.6.3 the Parties hereby confirm that the minimum Elan Royalty payable by Acorda to Elan shall be [***] of the NSP. Any dispute under this Article 5.6.3 (including one as to
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5.6.4
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No more than one royalty payment shall be due with respect to a sale of a particular Product (except any royalty payable under the Rush Payments Agreement). No multiple payments shall be payable because any Product or its manufacture, sale or use is covered by more than one Valid Claim covering the Product. No royalty payments shall be payable with respect to Products distributed for use in research and/or development, in clinical trials or as promotional samples.
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5.6.5
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All payments due hereunder shall be made in United States Dollars in accordance with Article 5.9.
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5.6.6
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For the avoidance of doubt, the Elan Royalty and any royalty payable under the Rush Payments Agreement shall be payable whether or not Elan is manufacturing and supplying the Product.
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5.7.
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Additional Expenses:
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5.8.
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Non-Refundable Payments:
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5.9.
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Payments, Reports and Records:
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5.9.1
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Acorda shall keep and shall cause its Affiliates and Designees to keep true and accurate records of gross sales of the Product, the items deducted from the gross amount in calculating the NSP, the NSP and the royalties payable to Elan under Article 5 hereof. Acorda shall deliver to Elan a written statement thereof within forty five (45) days following the end of each calendar quarter (or any part thereof in the first or last calendar quarter of this Agreement) for such calendar quarter. The said written statements shall set forth on a country-by-country basis, the calculation of the NSP from gross revenues during that calendar quarter, the applicable percentage rate, and a computation of the sums due to Elan (the “Statement”). The Parties’ financial officers shall agree upon the
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5.9.2
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Payments due on NSP of the Product based on sales amounts in a currency other than United States Dollars shall first be calculated in the foreign currency and then converted to United States Dollars on the basis of the exchange rate in effect for the purchase of United States Dollars with such foreign currency quoted in the Wall Street Journal (or comparable publication if not quoted in the Wall Street Journal) with respect to the sale of currency of the country of origin of such payment for the day prior to the date on which the payment by Acorda is being made. In order to facilitate the payments, the Parties may agree that with respect to a certain country or countries the payments due with regard to Product sales in such country or countries will be paid directly by the Acorda Designee(s) responsible for the marketing of the Product in such country or countries to Elan. In remitting such royalty payments such Designees(s) will abide by the terms of this Article 5.9. No such direct payments will be made by any Acorda Designee unless Acorda and Elan have beforehand agreed that such direct royalty payment and such direct payments shall not adversely affect the withholding liability of Elan compared to the payments made by Acorda to Elan.
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5.9.3
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If laws, rules or regulations require withholding of income taxes or other taxes imposed upon payments set forth in this Article 5, Elan shall provide Acorda, prior to any such payment, once each calendar year or more frequently if required, with all forms or documentation required by any applicable taxation laws, treaties or agreements to such withholding or as necessary to claim a benefit thereunder (including, but not limited to Form W-8BEN or any successor forms). Any such income or other taxes which Acorda is required by law to pay or withhold on behalf of Elan with respect to royalties and any other monies payable to Elan under this Agreement shall be deducted from the amount of such NSP payments, royalties and other monies due. Acorda shall furnish Elan with proof of such payments. Any such tax required to be paid or withheld shall be an expense of and borne solely by Elan. Acorda shall promptly provide Elan with a certificate or other documentary evidence to enable Elan to support a claim for a refund or a foreign tax credit with respect to any such tax so withheld or deducted by Acorda. Both Parties will reasonably cooperate in completing and filing documents required under the provisions of any applicable tax treaty or under any other applicable law, in order to enable Acorda to make such payments to Elan without any deduction or withholding.
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5.9.4
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All payments due hereunder shall be made to the designated bank account of Elan in accordance with such timely written instructions as Elan shall from time to time provide.
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5.9.5
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For the twenty four (24) month period following the close of each calendar year during the term of the Agreement, Elan and Acorda will provide each other’s independent certified accountants (reasonably acceptable to the other Party) with access, during regular business hours and upon reasonable prior request and
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5.9.6
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In addition, for the twenty four (24) month period following the close of each calendar year, Elan will provide Acorda’s independent certified accountants (reasonably acceptable to Elan) with access, during regular business hours and upon reasonable prior request and subject to the confidentiality provisions as contained in this Agreement, to Elan’s books and records relating to (i) the Manufacturing Cost of the Product; (ii) any activities undertaken by Elan on behalf of Acorda pursuant to Article 3; and (iii) any activities undertaken by Elan on behalf of Acorda pursuant to Article 6, in each case, for the purpose of verifying the reasonable basis of the payments made by Acorda hereunder with respect thereto.
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5.9.7
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Notwithstanding any other provision of this Agreement, if at any time legal restrictions prevent the prompt remittance of part or all of the payments due to Elan in any country, payment shall be made through such lawful means or methods as Acorda may determine after consultation with Elan. When in any country the law or regulations prohibit both the transmittal and deposit of royalties on sales in such a country, payments shall be suspended for as long as such prohibition is in effect and promptly after such prohibition ceases to be in effect, all royalties or other payments that Acorda or its Affiliates would have been obligated to transmit or deposit, but for the prohibition, shall be deposited or transmitted, as the case may be, to the extent allowable, less any transactional costs. If the royalty rate specified in this Agreement should exceed the permissible rate established in any country, the royalty rate for sales in such country shall be adjusted to the highest legally permissible or government-approved rate.
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6.1.
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As is stated at Article 3.7, a primary objective of the Project is to generate the NDA and to secure NDA Approval. As of the date of this Agreement, it is the Parties’ expectation that the body of data so generated during the Project will support such applications for Regulatory Approval that Acorda shall make in the other countries of the Territory.
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6.2.
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Subject to the review by the Committee pursuant to Article 10 and to Elan’s preparation and delivery to Acorda of the CMC Section in form and substance acceptable for inclusion in the NDA (as well as any revisions thereto as may be mandated or requested by the FDA), and to the other provisions of this Article 6, Acorda shall have the right and responsibility for filing, shall use its reasonable efforts to prosecute to approval, and shall own the NDA. It is acknowledged that Elan has assigned the IND to Acorda. Within ninety (90) days following the completion of the Project as determined by the Committee, Acorda shall submit the NDA for filing with the FDA.
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6.3.
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Acorda shall not alter the Specifications or any part of the CMC Section unless (a) by agreement with Elan, or (b) mandated by the FDA or other regulatory authority. In either case, Acorda shall promptly notify Elan and for changes made after NDA Approval, shall be responsible for Elan’s reasonable expenses associated with required changes to its manufacturing license(s).
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6.4.
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Subject to Elan preparing and delivering to Acorda the CMC Section as set forth in this Agreement, Acorda shall be responsible for obtaining all Regulatory Approvals necessary for Elan to package the Product into final market packaging. Acorda shall be responsible for obtaining all applicable FDA and other state and local regulatory approvals for the distribution of the Product in the United States of America and elsewhere. Elan shall co-operate with Acorda in obtaining such approvals.
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6.5.
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Acorda shall maintain at its own cost the NDA (and shall bear the cost of any amendments or supplements to the CMC Section, other than those requested by Elan, which costs shall be borne by Elan) with the FDA during the period that Acorda and/or its Designees are marketing the Product. Acorda shall continue to maintain the NDA with the FDA, at Elan’s request and expense, if Elan acquires the right to a licence in the United States or any other country in which the NDA is relied upon as the primary application for Regulatory Approval pursuant to Article 2.11.3 for such term thereafter during which Elan and/or its designees (for which purpose the definition of Designee as set out in Article 1 shall apply mutatis mutandis) is marketing the Product. Acorda hereby agrees to provide to Elan a copy of the NDA within thirty (30) days of the submission thereof to the FDA. Acorda shall also furnish a copy to Elan of all other regulatory filings and other material correspondence with the FDA and other regulatory authorities within thirty (30) days of submission. The NDA and any NDA Equivalent or application for Regulatory Approval filed in Territory for the Product shall remain the property of Acorda, provided that Acorda shall allow Elan access thereto to enable Elan to fulfil its obligations and exercise its rights hereunder.
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6.6.
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During the NDA registration procedure, Acorda shall keep Elan promptly and fully advised of Acorda’s registration activities, progress and procedures during Committee meetings. Elan and Acorda shall each before proceeding with any FDA filings, meetings or telephone conferences, inform and discuss the participation of the other with respect to any such proposed dealings with the FDA relating to the Product and shall promptly provide to that other copies of all correspondence with, and all documents and applications filed with, or submitted by it to, any regulatory authority with respect to Product; provided, however, that that the Parties acknowledge and agree that Acorda
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6.7.
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It is hereby acknowledged that there are inherent uncertainties involved in the development and registration of pharmaceutical products with the FDA or any other regulatory body in the United States of America insofar as obtaining approval is concerned and that such uncertainties form part of the business risk involved in undertaking the form of commercial collaboration as set forth in this Agreement. Therefore, save for using its reasonable efforts, neither Party shall have any liability to the other solely as a result of any failure of the Product to achieve the approval of the FDA, or any other regulatory body in the United States of America.
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6.8.
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Acorda shall also be responsible for the filing and prosecution at its own cost of the regulatory applications with the regulatory authorities in Japan, the Major European Markets and in such other countries of the Territory as it elects and Elan shall cooperate fully with Acorda in connection with such activities. The provisions of Articles 6.1 to 6.7 inclusive shall apply, mutatis mutandis, to Acorda’s and Elan’s obligations vis a vis Japan, the Major European Markets and such other countries of the Territory.
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8.1.
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Elan represents and warrants that Elan is the sole and exclusive owner or licensee of, or controls all right, title and interest in the Elan Intellectual Property; Elan has the right to grant the rights and licences granted herein, and the Elan Intellectual Property as it pertains to the Product and the Product is free and clear of any lien, encumbrances, security interest) or restriction on license; Elan will not grant during the term of this Agreement, any right, licence or interest in and to the Elan Intellectual Property or the Product, or any portion thereof, inconsistent with the licence granted to Acorda herein; and there are no pending or, to the knowledge of Elan, threatened, actions, suits, investigations, claims or proceedings in any way related to the Elan Intellectual Property or the Product. Insofar as such patent rights and know-how constitute Elan Patent Rights or Elan Know-How for the purposes of this Agreement, Elan represents and warrants that it is entitled to grant a licence to such patent rights and know-how as are developed by or on behalf of Elan pursuant to the Axogen Agreement, including any patent rights and non-patented know-how or other information which may be conceived, reduced to practice or otherwise developed by or on behalf of Elan pursuant to the Axogen Agreement. Elan agrees to hold Acorda harmless from any and all costs, expenses and damages (including reasonable attorneys’ fees) incurred or sustained by Acorda as the result of any Third Party’s challenges to Elan’s right to enter into this Agreement and to grant the rights and licences herein granted to Acorda and the Elan Intellectual Property.
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8.2.
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Elan represents and warrants that the execution of this Agreement and the full performance and enjoyment of the rights of Acorda under this Agreement will not breach or in any way
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8.3.
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Acorda represents and warrants that it has not granted any option, licence, right or interest in or to the Compound or to the Acorda Patent Rights to any Third Party which would conflict with the terms of this Agreement. Acorda agrees to hold Elan harmless from any and all costs, expenses and damages (including reasonable attorneys’ fees) incurred or sustained by Elan as the result of any Third Party’s challenges to Acorda’s right to enter into this Agreement.
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8.4.
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Acorda represents and warrants that the execution of this Agreement will not breach or in any way be inconsistent with the terms and conditions of any licence, contract, understanding or agreement, whether express, implied, written or oral between Acorda and any Third Party.
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8.5.
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Each Party represents and warrants that with respect to all data and information generated by it to support regulatory filings seeking to obtain approval of the regulatory authorities shall, to the best of that party’s knowledge, be free from fraud or material falsity and shall be accurate and reliable for purposes of supporting approval of the submissions. Each Party warrants that all regulatory applications made by that Party have not been and will not be obtained either through bribery or the payment of illegal gratuities, and that no Regulatory Approval shall be obtained with illegal or unethical behaviour of any kind.
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8.6.
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Elan represents and warrants that the Product supplied to Acorda by Elan under this Agreement has been and shall be free of any lien, security, interest or other encumbrance on title, conform to the Specifications and in accordance with all regulations and requirements of the FDA and foreign regulatory authorities including, without limitation, the cGMP regulations which apply to the manufacture, storage, packaging and supply of the Product. Elan represents and warrants that the Product supplied to Acorda under this Agreement has been and shall be free of defects in material and workmanship, shall not be adulterated or mis-branded as defined by the Act (or applicable foreign law) and shall not be a product which would violate any section of such Act if introduced in interstate commerce and shall be fit for use as a pharmaceutical product. Acorda agrees not to assert its right to rescind this Agreement (if any) in the event of a breach of the representations of Elan contained in this Article 8.6.
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8.7.
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Elan and Acorda is each fully cognisant of all applicable statutes, ordinances and regulations of the United States of America with respect to the manufacture of the Product including, but not limited to, the Act and regulations thereunder, cGLP, cGCP and cGMP. Elan shall manufacture or procure the manufacture the Product under this Agreement in conformity with the Specifications, the relevant portions of the CMC Section and, if applicable, the DMF and in a manner which fully complies with all United States of America and foreign statutes, ordinances, regulations and practices.
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8.8.
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Acorda shall indemnify and hold harmless Elan, its agents and employees from and against all claims, damages, losses, liabilities and expenses to which Elan, its agents, and employees may become subject related to or arising out of Acorda’s bad faith, gross negligence or intentional misconduct in connection with the filing or maintenance of the NDA. Elan shall indemnify and hold harmless Acorda, its agents and employees from and against all claims, damages, losses, liabilities and expenses to which Acorda, its agents, and employees may become subject related to or arising out of Elan’s bad faith, gross negligence or intentional misconduct in connection with the preparation of the CMC Section.
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8.9.
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Elan shall indemnify, defend and hold harmless Acorda and its officers, directors, employees and agents from all actions, losses, claims, demands, damages, costs and liabilities (including reasonable attorneys’ fees) due to Third Party claims to which Acorda is or may become subject insofar as they arise out of or are alleged or claimed to arise out of (i) any breach by Elan of any of its obligations under this Agreement, (ii) any breach of a representation or warranty of Elan made in this Agreement, (iii) any activities conducted by Elan in connection with the Project, (iv) any failure of the Product provided under this Agreement to meet the Specifications, or (v) the manufacture or shipment of the Product provided under this Agreement by Elan, except in each case to the extent due to the negligence or wilful misconduct of Acorda.
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8.10.
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Acorda shall indemnify, defend and hold harmless Elan and its officers, directors, employees and agents from all actions, losses, claims, demands, damages, costs and liabilities (including reasonable attorneys’ fees) due to Third Party claims to which Elan is or may become subject insofar as they arise out of or are alleged or claimed to arise out of (i) any breach by Acorda of any of its obligations under the Agreement, (ii) any breach of any representation or warranty of Acorda made in this Agreement, and (iii) any activities conducted by Acorda in connection with the Project, except to the extent due to the negligence or wilful misconduct of Elan.
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8.11.
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Acorda shall indemnify, defend and hold harmless Elan and its officers, directors, employees and agents from all actions, losses, claims, demands, damages, costs and liabilities (including reasonable attorneys’ fees) due to Third Party claims to which Elan is or may become subject insofar as they arise out of or are alleged or claimed to arise out of activities conducted by Acorda or its Designee in the manufacture, transport, packaging, storage, handling, distribution, promotion, marketing or sale of the Product, that was caused by the negligence or wrongful acts or omissions on the part of Acorda or its Designees, except in each case, to the extent covered by Article 8.10 or due to the negligence or wilful misconduct of Elan.
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8.12.
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Elan represents and warrants that, the manufacture, sale, distribution or use of the Product in the Territory solely because of the use of the Elan Intellectual Property does not, to Elan’s actual knowledge, infringe any patent owned by a Third Party, provided, that Elan represents and warrants that it is not aware of any pending or threatened proceeding or claim of any person or entity pertaining to the Product, that asserts the infringement of any patent owned by a Third Party. In the event that (I) a claim or proceedings are brought against Acorda and/or Elan by a Third Party alleging that the
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8.13.
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Elan has no actual knowledge that (a) the issued and unexpired patents included in the Elan Patent Rights are invalid or unenforceable over any references or prior art known to Elan or its agents, taken alone or in combination, nor (b) that the pending patent applications included in the Elan Patent Rights fail to include patentable subject matter, nor (c) that Elan and its agents have failed to comply with any duty of candor imposed on an applicant for patent before a particular national or regional patent office with respect to the patents, applications and patent offices listed in Schedule 3.
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8.14.
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Acorda represents and warrants that as of the date of this Agreement to Acorda’s actual knowledge, the development and manufacture of the Product by Elan or Acorda, or the manufacture, sale, distribution or use of the Product in the Territory, solely because of the use of the Acorda Patent Rights or Acorda Know-How will not to the best of Acorda’s belief infringe any patent owned by a Third Party.
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8.15.
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As a condition of obtaining an indemnity in the circumstances set out above, the Party seeking an indemnity shall:
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8.15.1
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fully and promptly notify the other Party of any claim or proceeding, or threatened claim or proceeding;
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8.15.2
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permit the indemnifying Party to take full care and control of such claim or proceeding;
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8.15.3
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assist in the investigation and defence of such claim or proceeding;
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8.15.4
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not compromise or otherwise settle any such claim or proceeding without the prior written consent of the other Party, which consent shall not be unreasonably withheld; and
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8.15.5
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take all reasonable steps to mitigate any loss or liability in respect of any such claim or proceeding.
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8.16.
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TO THE FULLEST EXTENT PERMITTED BY LAW, APART FROM THE FOREGOING REPRESENTATIONS, WARRANTIES AND INDEMNITY, ELAN MAKES NO ADDITIONAL REPRESENTATIONS OR WARRANTIES AND HEREBY DISCLAIMS ALL WARRANTIES, REPRESENTATIONS, AND LIABILITIES, WHETHER EXPRESS OR IMPLIED, ARISING FROM CONTRACT OR TORT (EXCEPT FRAUD), IMPOSED BY STATUTE OR OTHERWISE, RELATING TO THE PRODUCT AND/OR ANY PATENTS OR TECHNOLOGY USED OR INCLUDED IN THE PRODUCT, INCLUDING ANY WARRANTIES AS TO MERCHANTABILITY, FITNESS FOR PURPOSE, CORRESPONDENCE WITH DESCRIPTION, OR NON-INFRINGEMENT.
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8.17.
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EXCEPT IN RESPECT OF EACH PARTY’S LIABILITY TO INDEMNIFY THE OTHER AGAINST CLAIMS MADE BY A THIRD PARTY, NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, ELAN AND ACORDA SHALL NOT BE LIABLE TO THE OTHER BY REASON OF ANY REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR ANY DUTY OF COMMON LAW, OR UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL, SPECIAL OR INCIDENTAL OR PUNITIVE LOSS OR DAMAGE (WHETHER FOR LOSS OF CURRENT OR FUTURE PROFITS, LOSS OF ENTERPRISE VALUE OR OTHERWISE) AND WHETHER OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR EMPLOYEES OR AGENTS OR OTHERWISE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, EXCEPT THAT THIS LIMITATION SHALL NOT APPLY TO DAMAGES DIRECTLY OR INDIRECTLY ARISING FROM PERSONAL INJURY OR DEATH CAUSED BY THE DEFECTIVE DESIGN AND/OR MANUFACTURE OF THE PRODUCT.
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8.18.
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Elan represents and warrants that Elan Corporation plc will provide Elan Pharma Limited or any other subsidiaries with a licence and the rights to manufacture the Product in accordance with the terms of this Agreement and the Supply Agreement.
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10.1.
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Acorda and Elan shall establish the Committee to provide oversight, review and coordination relating to the development, manufacturing and supply, Regulatory Approval and commercialisation of the Product, and for resolution of disputed issues that may arise between the Parties under this Agreement or the Supply Agreement. Unless otherwise agreed, the Committee shall be comprised of six members, with three members appointed by each of Elan and Acorda. The operation of the Committee shall be as set forth at Article 10.2 to Article 10.5. Acorda and Elan each shall appoint a person (a “Primary Contact”) to be the primary contact between the Parties with respect to the Project and to coordinate correspondence and communications between the Parties. Each Party shall notify the other in writing within thirty (30) days after the
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10.2.
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Except as specifically set forth in this Agreement, the Committee shall be responsible for overseeing the Project, including the following:
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10.2.1
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reviewing and, if deemed necessary or desirable, updating the Development Plan, the Technology Transfer Responsibilities and the Project budget; and accordingly Elan shall advise the Committee if it believes that the budget for items of the Project has been or is likely to be significantly exceeded;
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10.2.2
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facilitating the transfer of know-how, regulatory correspondence and communications and other data as contemplated by this Agreement and the Supply Agreement;
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10.2.3
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reviewing and assessing the progress of development of Product and, to the extent contemplated by this Agreement, evaluating and, if determined by the Committee, approving Technology Transfer Responsibilities and authorizing Elan to perform tasks required in connection with development of and regulatory submissions relating to Product;
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10.2.4
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discussing objectives for and performance of the Product in the Territory, and the promotional activities and materials associated therewith;
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10.2.5
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resolving any disputes between the Parties relating to the Project, provided, however, that Acorda shall have the final decision as to all clinical trial protocols and the conduct of all clinical trials and marketing and promotional activities by Acorda or its Designee; and
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10.2.6
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such other activities as are delegated to the Committee under this Agreement.
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10.3.
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The Committee shall use its best efforts to resolve any disputed issues, conflicts or differences of opinion between the Parties under this Agreement. If the Committee is unable to reach a consensus on any issue within thirty (30) days after such issue being presented to the Committee by a Party, notwithstanding the exercise of its best efforts as provided in Article 10, then such issue shall be referred to the chief executive officers of Acorda and Elan Any final decision of the CEOs shall be conclusive and binding on the Parties hereto, and must be reached, if practicable under the circumstances, within thirty (30) days after being referred to the CEO, provided, however, that issues referred to in Article 10.2.5 as being subject to Acorda’s final decision shall be determined finally and conclusively by Acorda in the event that the Committee and/or the CEOs are unable to reach a consensus; provided further, that any such decision shall comply with applicable governmental regulatory requirements. Any matter as to which the CEOs are unable to reach agreement may be submitted by either Party to binding arbitration for final
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10.4.
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The Committee shall consist of the Primary Contact from each Party together with such additional business and development personnel from each Party who are deemed necessary to accomplish the work of the Committee. Unless otherwise agreed, the Committee shall meet at least once each calendar quarter, in person, or by video or telephone conference. In such instance, the next quarterly meeting will be scheduled. Meetings shall be chaired by the chief representative of Acorda and such representative shall be responsible for preparing minutes of such meetings.
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10.5.
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At each meeting, Acorda shall summarize the status of Acorda’s clinical development, regulatory and, if applicable, marketing and promotional activities with respect to Product. Any disclosures of such progress, results, data or know-how in any meeting shall be deemed Confidential Information of Acorda. At and between meetings of the Committee, each Party shall keep the other fully and regularly informed as to its progress with its respective obligations.
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10.6.
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The Committee shall not be empowered to alter the terms of this Agreement. The continuation of the Committee shall be at the discretion of the Parties as deemed appropriate to further the registration and commercialisation activities in the Territory.
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11.1.
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11.1.1
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Acorda shall have the first right to file, prosecute and maintain the Elan Patent Rights in Elan’s name, using patent counsel selected by Acorda, and shall be responsible for the payment of all related patent filing, prosecution and maintenance costs, subject to this Article 11.1.1. Upon Acorda’s request, Elan shall reasonably cooperate in the filing, prosecution or maintenance of any patent application or patent included in the Elan Patent Rights. If Acorda elects not to file, prosecute or maintain a patent application or patent included in the Elan Patent Rights in any particular country, it shall provide Elan with written advance notice sufficient to avoid any loss or forfeiture, or at least 60 days notice, and Elan shall have the right, but not the obligation, at its sole expense, to file, prosecute or maintain such patent application or patent in such country in Elan’s name. If Elan elects to file, prosecute or maintain a patent or application within the Elan Patent Rights that Acorda has elected not to file, prosecute or maintain, such patent or application in such country shall no longer be deemed an Elan Patent Right for purposes of the license in Article 2 to Acorda.
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11.1.2
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Acorda shall have the first right to file, prosecute and maintain any patent application(s) or patent(s) arising from Joint Inventions and shall be responsible for the payment of all related patent prosecution and maintenance costs. Upon Acorda’s request, Elan shall reasonably cooperate in the filing, prosecution or
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11.2.
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Acorda and Elan shall promptly inform the other in writing of any alleged infringement of which it shall become aware by a Third Party of any patents within the Elan Patent Rights and provide each other with any available evidence of infringement. The Parties will thereafter consult and cooperate to determine a course of action, including, without limitation, the commencement of legal action by either party. However, Acorda shall have the first right to initiate and prosecute such legal action at its own expense and in the name of Elan and Acorda, or to control the defense of any declaratory judgment action relating to Elan Patent Rights and Elan will co-operate with such action at Acorda’s request and expense. Elan shall receive [*] of any such recovery remaining after the deduction by Acorda of the reasonable expenses (including attorney’s fees and expenses) incurred in relation to such an infringement proceeding. In the alternative to the foregoing, the Parties may agree to institute such proceedings in their joint names and shall reach agreement as to the proportion in which they will share the proceeds of any such proceedings, and the expense of any costs not recovered, or the costs or damages payable to the Third Party. Should Acorda decide not to pursue such infringers within six (6) months of acquiring knowledge of such infringement, except with respect to Paragraph IV Certifications, in such case the time of notice shall not exceed 20 days, Elan may do so at its expense provided that Acorda shall receive [*] of any such recovery remaining after the deduction by Elan of the reasonable expenses (including attorney’s fees and expenses) incurred in relation to such an infringement proceeding. Acorda will co-operate with such action at Elan’s request and expense. The Party involved in any such claim, suit or proceeding, shall keep the other Party hereto reasonably informed of the progress of any such claim, suit or proceeding. For any such legal action or defense, in the event that any Party is unable to initiate, prosecute, or defend such action solely in its own name, the other Party will join such action voluntarily and will execute all documents necessary for the Party to prosecute, defend and maintain such action.
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11.3.
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11.3.1
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In the event that (I) a claim or proceedings are brought against Acorda and/or Elan by a Third Party alleging that the manufacture, sale, distribution or use of the Product in the Territory infringes the patent rights of such Third Party, and such alleged infringement results from the use of the Elan Intellectual Property, and (II) as of the date the Specifications for the Product have been agreed, Elan was or should reasonably have been aware of such Third Party patent rights, the following shall apply as regards the Third Party claim, including without
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11.3.1.1
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if Elan or its subcontractor is manufacturing the Product, Acorda shall bear the first [***] of Patent Expenses; Elan and Acorda shall bear the remaining Patent Expenses equally;
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11.3.1.2
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if Elan or its subcontractor is not manufacturing the Product, Acorda shall discharge the Patent Expenses. Acorda shall be entitled to credit the Patent Expenses from up to [***] of the royalty otherwise payable to Elan pursuant to Article 5.6 and may carry forward any such uncredited Patent Expenses to be credited against up to [***] of the royalty otherwise payable to Elan pursuant to Article 5.6 until fully expended; Elan and Acorda shall bear the remaining Patent Expenses equally.
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11.3.2
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In the event that a claim or proceedings are brought against Elan and/or Acorda by a Third Party alleging that the manufacture, sale, distribution or use of the Product in the Territory as a result of the use of the Elan Patent Rights or Elan Know-How infringes the patent rights of such a Third Party and Elan should not reasonably have been aware of such Third Party patent rights, Acorda and Elan shall meet to discuss in what manner the said proceedings should be defended and, the manner in which any award for damages, costs and expenses incurred in respect of or arising out of such a claim or proceedings should be borne as between Elan and Acorda.
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11.3.3
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Acorda shall reasonably consider taking such action as is reasonable, such as, to re-formulate or modify the applicable Product so as to avoid infringing the
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11.3.4
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Elan shall have no liability to Acorda whatsoever or howsoever arising for any losses incurred by Acorda as a result of having to cease selling Product or having to defer the launch of selling Product, as a result of a court order or settlement entered into pursuant to Article 11.5.
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11.4.1
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In the event that a claim or proceedings are brought against Elan by a Third Party alleging that the manufacture, sale, distribution or use of the Product in the Territory infringes the patent rights of such Third Party, and such alleged infringement results from the use of the Acorda Patent Rights or Acorda Know-How, Elan shall promptly advise Acorda of such threat or suit. Acorda shall indemnify Elan against such a claim, including without limitation, reasonable attorney’s fees and other expenses of the litigation, provided however, that as of the date the Specifications have been agreed, Acorda was or should reasonably have been aware of such Third Party patent rights; and further provided that Elan shall not acknowledge to the Third Party or to any other person the validity of the patent rights of such a Third Party and shall not compromise or settle any claim or proceedings relating thereto without the written consent of Acorda. At its option, Acorda may elect to take over the conduct of such proceedings from Elan.
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11.4.2
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In the event that a claim or proceedings are brought against Elan by a Third Party alleging that the manufacture, sale, distribution or use of the Product in the Territory solely as a result of the use of the Acorda Patent Rights or Acorda Know-How infringes the patent rights of such a Third Party and Acorda should not reasonably have been aware of such Third Party patent rights, Acorda and Elan shall meet to discuss in what manner the said proceedings should be defended and, the manner in which any award for damages, costs and expenses incurred in respect of or arising out of such a claim or proceedings should be borne as between Elan and Acorda.
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11.4.3
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In the event that a claim or proceedings are brought against Elan by a Third Party alleging that the manufacture, sale, distribution or use of the Product in the Territory infringes any patents held by such Third Party and Acorda or its Designee is manufacturing the Product, and the claim or proceeding results from the use of the patent rights or know-how of Acorda or its Designee (and not the Elan Intellectual Property), Elan shall promptly advise Acorda of such threat or suit. Acorda shall indemnify Elan against such a claim, including without limitation, reasonable attorney’s fees and other expenses of the litigation; provided that Elan shall not acknowledge to the Third Party or to any other person the validity of the patent rights of such a Third Party and shall not compromise or settle any claim or proceedings relating thereto without the written consent of Acorda. At its option, Acorda may elect to take over the conduct of such proceedings from Elan.
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11.5.
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In the event that a claim or proceedings are brought against either Party by a Third Party alleging that the sale, distribution or use of the Product in the Territory as a result of the use of the Joint Inventions infringes the patent rights of such a Third Party, Acorda and Elan shall meet to discuss in what manner the said proceedings should be defended and the manner in which any award for damages, costs and expenses incurred in respect of or arising out of such a claim or proceedings should be borne as between Elan and Acorda, provided, however, that Acorda shall have the first right to control the defense of such action relating to Joint Inventions and Elan will co-operate with such action at Acorda’s request and expense. Neither Party shall acknowledge to a Third Party or to any other person the validity of the patent rights of such a Third Party, the invalidity of the Elan Patent Rights or the Acorda Patent Rights and shall not compromise or settle any claim or proceedings relating thereto without the written consent of the other Party, such consent not to be unreasonably withheld or delayed. The Parties shall co-operate in relation to all material aspects of such litigation or other proceedings and shall meet to discuss in what manner the said proceedings should be defended. If one Party has control of the litigation or other proceeding pursuant to the terms of this Agreement and the other Party wishes to retain separate representation, the latter Party shall bear the costs of such representation.
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11.6.
|
Acorda agrees to mark all Product it sells or distributes pursuant to this Agreement with applicable patent numbers or otherwise in accordance with the applicable statute or regulations in the country or countries of manufacture and sale thereof.
|
|
|
|
|
12.1.
|
Secrecy:
|
|
|
|
12.1.1
|
Any Confidential Information pertaining to the Product that has been or will be communicated or delivered by Elan to Acorda, and any information from time to time communicated or delivered by Acorda to Elan, including, without limitation, trade secrets, business methods, and cost, supplier, manufacturing and customer information, shall be treated by Acorda and Elan, respectively, as Confidential Information, and shall not be disclosed or revealed to any Third Party whatsoever or used in any manner except as expressly provided for herein; provided, however, that such Confidential Information shall not be subject to the restrictions and prohibitions set forth in this section to the extent that such Confidential Information:
|
|
|
|
12.1.1.1
|
is available to the public in public literature or otherwise, or after disclosure by one Party to the other becomes public knowledge through no default of the Party receiving such confidential information; or
|
|
|
|
12.1.1.2
|
was known to the Party receiving such confidential information prior to the receipt of such confidential information by such Party, whether received before or after the date of this Agreement; or
|
|
12.1.1.3
|
is obtained by the Party receiving such confidential information from a Third Party not subject to a requirement of confidentiality with respect to such confidential information; or
|
|
|
|
12.1.1.4
|
is required to be disclosed pursuant to: (A) any order of a court having jurisdiction and power to order such information to be released or made public; or (B) any lawful action of a governmental or regulatory agency.
|
|
|
|
12.1.2
|
Each Party shall take all such precautions with Confidential Information disclosed to it by the other Party as it normally takes with its own confidential information to prevent any improper disclosure of the Confidential Information disclosed to it by the other Party to any Third Party; provided, however, that such confidential information may be disclosed within the limits required to obtain any authorisation from the FDA or any other United States of America or foreign governmental or regulatory agency or, with the prior written consent of the other Party, which shall not be unreasonably withheld, or as may otherwise be required in connection with the purposes of this Agreement.
|
|
|
|
12.1.3
|
Notwithstanding the above, each Party hereto may use or disclose Confidential Information disclosed to it by the other Party to the extent such use or disclosure is reasonably necessary in filing or prosecuting patent applications, prosecuting or defending litigation, complying with applicable governmental regulations or otherwise submitting information to tax or other governmental authorities, conducting clinical trials, or making a permitted sub-licence or otherwise exercising its rights hereunder, provided that if a Party is required to make any such disclosure of the other party’s Confidential Information, other than pursuant to a confidentiality agreement, it will given reasonable advance notice to the latter Party of such disclosure and, save to the extent inappropriate in the case of patent applications and regulatory submissions, will use its best efforts to secure confidential treatment of such information prior to its disclosure (whether through protective orders or otherwise).
|
|
|
|
12.1.4
|
Each Party agrees that it will not use, directly or indirectly, any Confidential Information disclosed by the other Party pursuant to this Agreement or the Supply Agreement, other than as expressly provided herein or in the Supply Agreement.
|
|
|
|
12.1.5
|
Acorda and Elan will not publicise the existence of this Agreement in any way without the consent of the other, which consent shall not be unreasonably withheld or delayed, subject to the disclosure requirements of applicable laws and regulations; provided, however, that it is understood that the Parties or their Affiliates may make disclosure of this Agreement and the terms hereof in any filings required by the SEC, may file this Agreement as an exhibit to any filing with the SEC and may distribute any such filing in the ordinary course of its business, provided, further, that to the maximum extent allowable by SEC rules and regulations, the Parties shall be seek to maintain the confidentiality
|
|
|
12.2.
|
Assignments/ Subcontracting:
|
|
|
|
12.2.1 Subject to the provisions of this Article 12.2, each party be entitled without the consent of the other:
|
|
|
|
12.2.1.1
|
to subcontract or delegate the whole or any part of its duties hereunder to its Affiliate(s) (but shall remain responsible for its obligations under this Agreement); and/or
|
|
|
|
12.2.1.2
|
to assign this Agreement to its Affiliate, provided that such assignment has no material adverse tax implications for the other party or parties hereto, and provided further that the assigning Party shall remain liable and responsible with such assignee to the other Party for the performance of any obligations, representations or warranties delegated, contracted, assigned or otherwise transferred to any such assignee.
|
|
|
|
12.2.2
|
Elan may, but shall not be obliged to, assign its rights and obligations under this Agreement to a Permitted Assignee (as such term is defined in the Supply Agreement) of the Supply Agreement.
|
|
|
|
12.2.3
|
Each Party may assign all (but not a portion) of its rights and obligations under this Agreement to an entity that acquires all or substantially all of its business or assets to which this Agreement pertains, whether by merger, reorganisation, acquisition, sale or otherwise.
|
|
|
|
12.2.4
|
Except as provided for in this Article 12.2, this Agreement may not be assigned by a party without the prior written consent of the other Party, which shall not be unreasonably withheld or delayed.
|
|
|
|
12.2.5
|
Any permitted assignee of a Party under this Article 12.2 shall assume all related obligations of its assignor under this Agreement.
|
|
|
12.3.
|
Parties bound:
|
|
|
12.4.
|
Severability:
|
12.5.
|
Duration and Termination:
|
|
|
|
12.5.1
|
|
|
|
12.5.1.1
|
Subject to the other provisions of Article 12.5, this Agreement shall remain in full force and effect for a period commencing as of the date of this Agreement and shall expire on a country by country basis on the latest of:
|
|
|
|
(a)
|
fifteen (15) years starting from the Amendment Date;
|
|
|
|
(b)
|
expiry of the last to expire patent included in the Elan Patent Rights in that country; and
|
|
|
|
(c)
|
the existence of Competition in that country
|
|
|
|
(the “Initial Period”).
|
|
12.5.1.2
|
At the end of the Initial Period, the Agreement may be continued for five (5) year terms by the consent of the Parties, which consent shall not be unreasonably withheld or delayed. The Party requiring the extension shall serve two (2) years written notice on the other prior to the end of the Initial Period or any additional five (5) year period.
|
|
|
|
12.5.2
|
The Agreement shall be subject to earlier termination in accordance with the following provisions:
|
|
|
|
12.5.2.1
|
Acorda may terminate this Agreement in its entirety or with respect to any country with thirty (30) days prior written notice to Elan prior to Regulatory Approval, and with ninety (90) days prior written notice to Elan at any time thereafter;
|
|
|
|
12.5.2.2
|
subject to the determination in an arbitration that Acorda has breached the applicable provisions, Elan may terminate the Agreement for the applicable region(s) or country or countries of the Territory if Acorda breaches the provisions of Article 2.11.3, or Acorda indicates to Elan pursuant to Article 2.11.4.3, that it does not intend to obtain Regulatory Approval and commercialise the Product, and Elan does not exercise its option to take a licence to the
|
|
|
|
12.5.3
|
In addition to the rights of early or premature termination provided for elsewhere in this Agreement, in the event that any of the terms or provisions hereof are incurably breached by either Party, the non-breaching Party may immediately terminate this Agreement by written notice. An incurable breach shall be committed when either Party is dissolved, liquidated, discontinued, becomes insolvent, or when any proceeding is filed or commenced by either Party under bankruptcy, insolvency or debtor relief laws. In the event of any other breach, the non-breaching Party may terminate this Agreement by the giving of written notice to the breaching Party that this Agreement will terminate on the sixtieth (60th) day from notice unless cure is sooner effected. If the breaching Party has proposed a course of action to rectify the breach and is acting in good faith to rectify same but has not cured the breach by the sixtieth (60th) day, the said period shall be extended by such period as is reasonably necessary to permit the breach to be rectified.
|
|
|
|
12.5.4
|
Upon exercise of those rights of termination as specified in Article 12.5.2, or Article 12.5.3, in any country or countries or the entire Agreement as the case may be, this Agreement shall, subject to the other provisions of the Agreement and Article 12.5.5, automatically terminate forthwith in the applicable country or countries or the entire Agreement as the case may be, and be of no further legal force or effect.
|
|
|
|
12.5.5
|
Upon termination of the Agreement:
|
|
|
|
12.5.5.1
|
any sums that were due from Acorda to Elan prior to the exercise of the right to terminate this Agreement (including but not limited to, Research and Development Costs and such additional expenses pursuant to Article 5.7 in each case incurred prior to the notice of termination, shall be paid in full within sixty (60) days of termination of this Agreement;
|
|
|
|
12.5.5.2
|
all confidentiality provisions set out herein shall remain in full force and effect for a period of five (5) years;
|
|
|
|
12.5.5.3
|
all representations and warranties shall insofar are appropriate remain in full force and effect;
|
|
|
|
12.5.5.4
|
the rights of inspection and audit shall continue in force for the period referred to in the relevant provisions of this Agreement;
|
|
|
|
12.5.5.5
|
termination of this Agreement for any reason shall not release any Party hereto from any liability which, at the time of such termination, has already accrued to the other Party or which is attributable to a period prior to such termination nor preclude either
|
|
|
|
12.5.5.6
|
save and except as is necessary to enable Elan to exercise the licences granted by Acorda to Elan pursuant to Article 2.9 and Article 2.11.3, upon any termination of this Agreement, Acorda and Elan shall promptly return to the other Party all Confidential Information received from the other Party (except one copy of which may be retained for archival purposes); and
|
|
|
|
12.5.5.7
|
in the event this Agreement is terminated for any reason, Acorda and its Designees shall have the right for a period of six (6) months from termination to sell or otherwise dispose of the stock of any Product then on hand, which such sale shall be subject to the terms of the Supply Agreement.
|
|
|
|
12.5.5.8
|
Article 1, Article 2.2, Article 8, Article 11.1.1, 11.1.2, 11.2, 11.3, 11.4, 11.5, and Article 12 shall survive the termination or expiration of this Agreement for any reason.
|
|
|
|
12.5.6
|
|
|
|
12.5.6.1
|
In the event of termination of the licences to the Elan Intellectual Property granted by Elan to Acorda pursuant to Article 2.11.3 as to any country or countries or in the event of the termination of this Agreement by Elan pursuant to Article 12.5.3, Acorda shall at the option of Elan grant a licence to the Acorda Patent Rights and the Acorda Know-How, including the data, information, Regulatory Applications, Regulatory Approvals, pricing and reimbursement approvals to enable Elan to commercialise the Products in such country or countries on the terms set out in Article 2.11.3 and to the Trademark on the terms set out in Article 2.9.
|
|
|
12.6.
|
Force Majeure:
|
|
|
12.7.
|
Relationship of the Parties:
|
|
|
12.8.
|
Amendments:
|
|
|
12.9.
|
Waiver:
|
|
|
12.10.
|
No effect on other agreements:
|
|
|
12.11.
|
Applicable Law:
|
|
|
12.12.
|
Notice:
|
|
|
|
12.12.1
|
Any notice to be given under this Agreement shall be sent in writing in English by registered airmail or faxed to:
|
|
|
Elan at
|
|
c/o Elan International Services Ltd.
|
|
102 St. James Court
|
|
Flatts,
|
|
Smiths FL04
|
|
Bermuda
|
|
Attention: Secretary | |
Fax: +1 441 292 2224 | |
Acorda at:
|
|
Acorda Therapeutics, Inc.
|
|
15 Skyline Drive
|
|
Hawthorne, New York 10532
|
|
United States of America
|
|
Attention: Chief Executive Officer | |
Fax : +1 914.347.4560 |
|
12.12.2
|
Any notice sent by registered air-mail shall be deemed to have been delivered within seven (7) working days after despatch and any notice sent by fax shall be deemed to have been delivered within twenty four (24) hours of the time of the despatch. Notice of change of address shall be effective upon receipt.
|
12.13.
|
No Implied Rights:
|
|
|
12.14.
|
Arbitration:
|
|
|
12.15.
|
Independent Development:
|
|
|
12.16.
|
Further Assurances:
|
|
|
12.17.
|
Entire Agreement:
|
|
|
12.18.
|
Counterparts:
|
|
|
SIGNED
|
|||
/s/ Klaas van Blanken/Pieter Bosse
|
|||
for and on behalf of
|
|||
ELAN CORPORATION, PLC.
|
|||
Name:
|
Monksland Holding BV
|
||
Title:
|
Proxyholder
|
||
SIGNED
|
|||
/s/ Ron Cohen
|
|||
for and on behalf of
|
|||
ACORDA THERAPEUTICS, INC.
|
|||
Name:
|
Ron Cohen
|
||
Title:
|
President & Chief Executive Officer
|
||
|
|
Country
|
Patent Number
|
Grant Date
|
Status
|
Inventors
|
||||
US
|
5,952,357
|
14-Sept-1999
|
Issued
|
Blass, J. et al.
|
||||
Title: TREATING DISEASES OF THE ANTERIOR HORN CELLS
|
||||||||
US
|
5,545,648
|
13-Aug-1996
|
Issued
|
Hansebout, R, et al.
|
||||
Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION
|
||||||||
AU
|
676,251
|
03-June-1997
|
Granted
|
Hansebout, R, et al.
|
||||
Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION
|
||||||||
CZ
|
28441
|
20-Dec-1993
|
Granted
|
Hansebout, R, et al.
|
||||
Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION
|
||||||||
EP
|
0626848
|
04-June-2003
|
Granted
|
Hansebout, R, et al.
|
||||
Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION
|
||||||||
HU
|
219583
|
19-Mar-2001
|
Granted
|
Hansebout, R, et al.
|
||||
Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION
|
KP
|
31250
|
25-Aug-1997
|
Granted
|
Hansebout, R, et al.
|
||||
Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION
|
||||||||
KR
|
301415
|
25-June-2001
|
Granted
|
Hansebout, R, et al.
|
||||
Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION
|
||||||||
NO
|
308.644
|
25-June-2001
|
Granted
|
Hansebout, R, et al.
|
||||
Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION
|
||||||||
NZ
|
258844
|
22-Sept-1997
|
Granted
|
Hansebout, R, et al.
|
||||
Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION
|
||||||||
RU
|
2160590
|
23-May-2000
|
Granted
|
Hansebout, R, et al.
|
||||
Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION
|
||||||||
SK
|
280922
|
20-Dec-1993
|
Granted
|
Hansebout, R, et al.
|
||||
Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION
|
BG
|
99047
|
20-Dec-1993
|
Pending
|
Hansebout, R, et al.
|
||||
Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION
|
||||||||
CA
|
2,085,785
|
20-Dec-1993
|
Pending
|
Hansebout, R, et al.
|
||||
Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION
|
||||||||
JP
|
6-514637
|
20-Dec-1993
|
Pending
|
Hansebout, R, et al.
|
||||
Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION
|
1806
|
Formulations and their use in the treatment of neurological diseases
|
Pending:
Canada
Ireland
Japan
|
2054822
3952/90
349324/1991
|
|||
Issued:
Australia
Europe
New Zealand
South Africa
United States
|
657706
484186
240439
91/8711
5370879
5540938
5580580
|
|||||
1832
|
Matrix Formulation of Potassium Chemical Blockers (Fampridine II)
|
Pending:
United States
|
10/389,791
|
|
|
|
•
|
Elan will send to Patheon API, standards and samples of drug product batches required to successfully transfer the drug substance and drug product methods
|
|
|
|
•
|
Elan will test and release API lots for the Patheon technology transfer studies
|
|
|
|
•
|
Elan will send copies to Patheon of methods, specifications, method validation reports, batch formulae, component specifications, tablet tooling drawings, and process information as needed, to initiate method and process technology transfer
|
|
|
|
•
|
Elan will review and approve method and process technology transfer protocols prepared by Patheon
|
|
|
|
•
|
Elan will approve methods and process technology transfer reports
|
|
|
|
•
|
Elan will consult with Patheon on issues as they arise during the method and process technology transfer; if required, an Elan analyst or process chemist will travel to Patheon to provide on-site assistance and training on the methods
|
|
|
|
•
|
Elan will review analytical data and executed batch records generated from Patheon’s technology transfer work in connection with batch release by Patheon
|
|
•
|
Acorda will manage Patheon project timelines
|
|
|
|
•
|
Acorda will provide project management and technology assessment review support during method and process technology transfer
|
|
|
|
•
|
Acorda will manage and approve the budget for the Patheon technology transfer work
|
|
|
|
•
|
Acorda will consult with Patheon on issues as they arise during the method and process technology transfer; if required, an Acorda representative will travel to Patheon to participate in technical/project team meetings
|
|
|
|
•
|
Elan will provide technical support and guidance to Patheon if technical issues arise
|
|
|
|
•
|
Elan will perform release testing and regulatory release of API lots for the Patheon process validation studies if validation occurs prior to NDA approval
|
|
|
|
•
|
Acorda will review batch record and quality control documentation in connection with regulatory release by Patheon of process validation batches
|
|
|
|
•
|
Acorda will manage the Patheon project
|
|
|
|
•
|
Acorda will be responsible for compliance oversight of Patheon
|
|
•
|
Acorda will review and approve all validation protocols and final reports generated by Patheon, as needed
|
|
|
|
•
|
Acorda will review analytical data and batch records generated by Patheon in connection with regulatory release by Patheon
|
|
|
|
•
|
Acorda will provide project management and technology assessment oversight and review support to Patheon
|
|
|
|
•
|
Acorda will prepare the CTD Quality section for the NDA as it pertains to Patheon
|
|
|
|
•
|
Elan will review and approve Cardinal stability protocols
|
|
|
|
•
|
Elan will review data generated from Cardinal’s analytical testing as needed
|
|
|
|
•
|
Elan will review stability data tables generated from the Cardinal stability studies
|
|
|
|
•
|
Elan will notify Acorda of any out-of-specification results reported to them by Cardinal or discovered during the Elan review of stability data
|
|
|
|
•
|
Elan will consult with Cardinal on issues as they arise during the stability studies; if required, an Elan analyst will travel to Cardinal to provide on-site assistance and training on the methods
|
|
|
|
•
|
Elan will audit Cardinal and will be responsible for compliance oversight during the Cardinal stability studies
|
|
|
|
•
|
Elan will participate and provide technical support during product-specific PAI activities at Cardinal as needed
|
|
•
|
Acorda will participate in discussions with Cardinal and Elan on technical and project management issues
|
|
|
|
•
|
Acorda will review stability protocols and final stability reports from the Cardinal studies
|
|
|
|
•
|
Acorda will manage and approve the budget for the Cardinal stability studies
|
|
|
|
•
|
Acorda will consult with Cardinal and Elan on issues as they arise during stability studies; if required, an Acorda representative will travel to Cardinal to participate in technical/project team meetings
|
|
|
|
•
|
Acorda may participate in technical meetings with Cardinal and/or compliance audits that pertain to fampridine stability studies
|
|
•
|
Elan will provide technical advice to API manufacturers (Regis and Uetikon)
|
|
|
|
•
|
Elan will perform regulatory release testing and will release batches for all incoming lots of API to be used in routine production at Elan and through process validation at Patheon (if validation takes place prior to NDA approval)
|
|
|
|
•
|
Elan will oversee and review process validation activities at the API manufacturers
|
|
|
|
•
|
Elan will participate and provide technical support during product-specific PAI activities at the API manufacturers as needed
|
|
|
|
•
|
Elan will review API manufacturer’s regulatory documentation in connection with DMF submission by the API manufacturers in connection with NDA submission
|
|
|
|
•
|
Elan will notify Acorda of any out-of-specification results reported to them by API manufacturers
|
|
|
|
•
|
Elan will be responsible for auditing and assuring cGMP compliance at the API API manufacturers
|
|
|
|
•
|
Elan will purchase API and manage supply chain logistics in connection with API to be used in Elan drug product production
|
|
•
|
Elan will purchase and manage supply chain logistics in connection with API to be used in Patheon drug product only prior to NDA approval (in connection with technology transfer work and through process validation if validation occurs before NDA approval)
|
|
•
|
Acorda will participate in discussions with API manufacturers on technical and project timeline issues
|
|
|
|
•
|
Acorda will provide technical review support in connection with preparation of technical reports, regulatory documentation and validation documentation in connection with commercial scale-up and process optimization activities at the API manufacturers
|
|
|
|
•
|
Acorda will participate in compliance audits of API manufacturers
|
|
|
|
•
|
Acorda will review and advise Elan on budget matters in connection with API manufacturing and development
|
|
|
|
•
|
Acorda will consult with Elan and API manufacturers on issues as they arise during development; if required, an Acorda representative will travel to the API manufacturers to participate in technical/project team meetings
|
|
|
|
•
|
Acorda will be responsible for purchasing API to be used in commercial production of Patheon drug product
|
|
|
Event
|
Milestone Payment
|
|||
Upon the issuance of the first U.S. patent included in the Licensed Patents which claims the use of chondroitinase to treat CNS damage in humans.
|
[***]
|
|||
Upon the first IND filing to conduct a Phase I Clinical Trial for a Licensed Product.
|
[***]
|
|||
Upon successful completion of the first U.S. Phase I Clinical Trial for a Licensed Product.
|
[***]
|
|||
Upon successful completion of the first U.S. Phase II Clinical Trial for a Licensed Product.
|
[***]
|
|||
Upon the approval of the first U.S. New Drug Application for a Licensed Product.
|
[***]
|
|||
Upon receiving Regulatory Approval anywhere in the Licensed Territory for other indications of a Licensed Product, excluding any spinal cord injury indications (the “Indication Milestone”).
|
[***]
|
For Acorda:
|
Acorda Therapeutics, Inc.
|
|||
15 Skyline Drive
|
||||
Hawthorne, New York 10532 USA
|
||||
Attention:
|
Harold Safferstein, Vice President,
|
|||
Business Development
|
||||
Fax Number:
|
(914) 347-4560
|
|||
For CUTS:
|
Cambridge University Technical Services Limited
|
|||
c/o Research Services Division
|
||||
University of Cambridge
|
||||
16 Mill Lane
|
||||
Cambridge CB2 1SB, UK
|
||||
Attention: Director
|
||||
Fax Number: +44 (0)12 2333 2988
|
||||
For KCL:
|
King’s College London
|
|||
KCL Enterprises Ltd
|
||||
James Clerk Maxwell Building
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57 Waterloo Road
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London, SEI 8WA, UK
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Attention: Director of Technology Transfer
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Fax Number: +44 (0)20 7848 3320
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ACORDA THERAPEUTICS, INC.
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CAMBRIDGE UNIVERSITY TECHNICAL
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SERVICES LIMITED
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By:
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/s/ Hank Safferstein
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By:
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/s/ R. C. Jennings
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Print Name:
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Hank Safferstein
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Print Name:
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DR. R. C. Jennings
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Title:
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V.P. Business Dev.
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Title:
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DIRECTOR
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By:
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/s/ SUSAN SMITH
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Print Name:
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SUSAN SMITH
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Title:
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DIRECTOR OF TECHNOLOGY TRANSFER
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ELAN PHARMA INTERNATIONAL LIMITED
AND
ACORDA THERAPEUTICS, INC.
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DEVELOPMENT AND SUPPLEMENTAL AGREEMENT TO
AMENDED AND RESTATED LICENSE AGREEMENT
DATED 26 SEPTEMBER 2003 AS AMENDED AND SUPPLY AGREEMENT DATED 26 SEPTEMBER 2003
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1.
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Definitions and Interpretation
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1 |
2.
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Effect on Existing Agreements |
3
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4.
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Non-Elan Development Product |
5
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5.
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Manufacture and Supply of Pre-Commercial Batches |
6
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6.
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Registration
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7
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7.
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Additional Financial Provisions
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7
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8.
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Application of License Agreement
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8
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9.
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Development Product Supply Agreement
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9
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10.
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Non-Elan Development Product Supply Option
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9
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11.
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Term and Termination
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10
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12.
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Warranties |
12
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14.
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Assignment
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13
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15.
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General |
13
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Schedule 1 | [*****] | 17 |
Schedule 2 | Work Plan Format | 18 |
Schedule 3 | Selection Criteria | 19 |
(1)
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ELAN PHARMA INTERNATIONAL LIMITED, with an address at Monksland, Athlone, Co. Westmeath, Ireland (“Elan”) and
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(2)
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ACORDA THERAPEUTICS, INC., a Delaware corporation with an office at 15 Skyline Drive, Hawthorne, NY 10532, USA (“Acorda”)
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(A)
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Elan Corporation, plc. and Acorda are parties to (i) an Amended and Restated License Agreement dated 26 September 2003 pursuant to which, inter alia, Elan Corporation plc. granted certain licenses under its intellectual property in respect of mono- and di-aminopyridines (as amended by Amendment No. 1 defined below, the “License Agreement”) and (ii) a Supply Agreement dated 26 September 2003 pursuant to which Elan Corporation agreed to supply Product to Acorda (as amended by Amendment No. 1 defined below, the “Supply Agreement”).
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(B)
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Elan is the successor in interest of Elan Corporation, plc.'s rights and obligations under the above described agreements.
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(C)
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By an Amendment No. 1 Agreement to the License Agreement and Supply Agreement and Consent to Sublicense dated 30 June 2009 (“Amendment No. 1”), Elan and Acorda made certain amendments to the said agreements. The License Agreement, Supply Agreement, and Amendment No. 1 are referred to herein as the “License and Supply Agreement.”
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(D)
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The Parties wish to pursue the development of one or more new formulations of the Compound and/or Alternate Compounds for existing and/or new indications and the commercialization of one of these additional formulations. The formulations will use Elan technologies upon the terms and conditions of the License and Supply Agreement and the terms and conditions set out below and/or third party technologies upon the terms and conditions set out below and specifically stated as applicable to a formulation developed using third party technologies. The Parties also wish to further to provide for certain clarifications in respect of the application of provisions of the License and Supply Agreement to formulations using Elan technologies.
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1.
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Definitions and Interpretation
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1.1
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Definitions:
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"Agreement"
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means this agreement, including its recitals, with the attached Schedules.
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“ Compound Know-How and First Product Know-How”
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means the Elan Know-How that is or will be disclosed to Acorda in relation to the Compound or to the First Product under the License or Supply Agreement. For clarity and avoidance of doubt this term shall not include any knowledge, information, trade secrets, data or expertise which is generated or created by Elan in any Further Development Plan activities.
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“Compound and First Product Know-How License”
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has the meaning set forth in Clause 4.7.
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“Development Product”
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means the Product developed by Acorda and Elan pursuant to this Agreement, the Further Development Plan and one or more Work Plans, which Product incorporates the Development Technology. “Development Product” does not include the “First Product” but is a “Product” under the License Agreement.
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“Development Product Supply Agreement”
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has the meaning set forth in Clause 9.
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“Development Technology”
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means the technology which is developed by Elan and/or Acorda pursuant to this Agreement.
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“First Product”
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means that specific formulation (twice daily) of the Product that is marketed as of the Effective Date in the United States under the trademark “Ampyra®”.
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“Further Development Plan”
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means the development plan for the Development Product, which as of the Effective Date is set out in Schedule 1, as it may be amended by Elan and Acorda from time to time and set out in any amendment to the Further Development Plan that may be generated in accordance with Clause 3.2 of this Agreement.
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“Non-Elan Developer”
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means any individual or entity other than Elan (including Acorda).
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“Non-Elan Development Product”
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means a formulation of Compound or an Alternate Compound developed or to be developed by a Non-Elan Developer to meet the Selection Criteria. For clarity, “Non-Elan Development Product” shall not be regarded as a “Product” for the purposes of the License and Supply Agreement or this Agreement.
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“Non-Elan Development Product Supply Agreement”
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has the meaning set forth in Clause 10.4.1
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“Non-Elan Party Election”
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has the same meaning as that set forth in Clause 10.2.
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“Selection Criteria”
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means the target criteria for the Development Product and for each Non-Elan Development Product, as specified to Non-Elan Developers and as may be amended from time to time, which as of the Effective Date are set forth in Schedule 3.
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“Work Plan”
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means each written plan for development of Product agreed upon by Acorda and Elan, which Work Plan sets forth the goals of the work, allocates the responsibilities of the parties for conducting the work, timelines, and any other terms and conditions agreed upon between the parties. All Work Plans shall be consecutively numbered and, upon execution by authorized representatives of the parties, shall be incorporated by reference into this Agreement.
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1.2
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Interpretation: In this Agreement:
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1.2.1
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capitalised expressions not specifically defined in this Agreement shall have the same meaning as in the License and Supply Agreement, as applicable;
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1.2.2
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references to clauses are to clauses of this Agreement unless stated otherwise; and
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1.2.3
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this Agreement shall otherwise be interpreted in the same manner as the License and Supply Agreement.
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2.
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Effect on Existing Agreements
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2.1
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Except as expressly provided herein, the parties agree and acknowledge that the development, commercialization and commercial supply of the Development Product shall be governed by the License Agreement, the agreements incorporated by reference in the License Agreement, the Development Product Supply Agreement and in each case any amendments thereto (including but not limited to Amendment No 1). For clarity, the Development Plan does not apply to the Development Product or the Non-Elan Development Product.
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2.2
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For the purposes of clarity, the License Agreement as amended, the agreements incorporated by reference in the License Agreement, Supply Agreement and Amendment No. 1 shall continue to govern the development, commercialization and commercial supply of the First Product. For clarity and avoidance of doubt, the Parties hereby acknowledge that the consent granted by Elan to Acorda in Section 1 of the Amendment No. 1 is not modified by this Agreement.
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2.3
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At appropriate times during the Term, Elan and Acorda agree that they will discuss in good faith any clarifications as may be required to any operational provisions in the License and Supply Agreement to support the development, commercialization and commercial supply of any Development Product. Any such clarifications shall be set forth in an amendment to this Agreement (or other written, duly executed Elan/Acorda agreements), executed by authorized representatives of Acorda and Elan. The Parties agree that to the extent this Agreement specifically states that certain provisions of the License Agreement and the Supply Agreement apply to Non-Elan Development Product, any capitalized terms used within the License Agreement and Supply Agreement as so referenced shall have the meaning set forth in the License Agreement or the Supply Agreement, as the case may be, unless this Agreement specifically states otherwise.
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3.
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Development and Project Management (Development Product)
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3.1
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Without prejudice to Acorda’s rights to cease development of the Development Product at any time, throughout the Term and in accordance with the Further Development Plan and the applicable Work Plan(s), Elan and Acorda shall use commercially reasonable efforts to develop Development Product in accordance with the Further Development Plan(s). For the purpose of clarity, Acorda, in its sole discretion, may choose to cease development of the Development Product in the event that Acorda determines that continuing such development is no longer commensurate with the achievement of its own business aims. The decision not to further develop, if made by Acorda, shall not be subject to review by the Committee nor shall it be subject to arbitration under Section 12.14 of the License Agreement.
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3.2
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The Further Development Plan and the applicable Work Plan(s) set forth the agreed respective responsibilities of Elan and Acorda with respect to the development of the Development Product. Without prejudice to Acorda’s right to cease development at any time during the term of the Further Development Plan, Elan and Acorda shall undertake their respective obligations under the Further Development Plan and the applicable Work Plan(s) on a collaborative basis and using commercially reasonable efforts. Changes may be made to the Further Development Plan by mutual, written agreement of the parties through the Committee referenced in Section 10 of the License Agreement, which written agreement shall be set forth in an amendment to the Further Development Plan and/or Work Plan, as applicable.
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3.3
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Detailed development work shall be agreed and set out by the parties in one or more Work Plans, which shall be in a form broadly similar to the Work Plan format attached hereto as Schedule 2. Each Work Plan must be mutually agreed by both parties and accepted and signed by a duly authorized representative of both parties. Executed Work Plans shall form a part of this Agreement.
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3.4
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Within two (2) weeks of the Effective Date of this Agreement, the parties will establish a project team (“Project Team”), which shall convene regularly to keep the parties fully informed as to their progress with its respective tasks and obligations under the Further Development Plan and Work Plan(s). The Project Team shall monitor the progress of such activities.
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3.5
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Elan and Acorda shall update each other at meetings of the Committee as to the progress of their respective obligations under the Further Development Plan and the Work Plan(s).
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3.6
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The parties shall co-operate in good faith through the Project Team and the Committee particularly with respect to unknown problems and contingencies and shall perform their respective obligations in a commercially reasonable, diligent and workmanlike manner and in accordance with all applicable laws, regulations and guidelines.
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3.7
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Provided that a party uses reasonable endeavours to meet its obligations under this Agreement, it shall have no liability to the other as a result of any failure or delay of the Development Product to achieve any of the goals set out in the Further Development Plan or a Work Plan(s), nor for any failure of a Development Product to obtain NDA Approval or Regulatory Approval.
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4.
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Non-Elan Development Product
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4.1
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Acorda shall afford Elan a reasonable opportunity to develop a formulation meeting the Selection Criteria, and Elan and Acorda shall reasonably cooperate to enable that opportunity. The parties further agree that the entry into this Agreement and the performance of the Further Development Plan set out in Schedule 1 meet this obligation in respect of Elan being afforded a reasonable opportunity and provided with the Selection Criteria for the Development Product, as they exist as of the Effective Date.
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4.2
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Subject to Clause 4.3, in the event that Acorda selects to commercialize the formulation of a Non-Elan Developer, Acorda shall discuss the reasons for its selection with Elan.
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4.3
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Elan acknowledges and agrees that the final decision on which formulation to develop and commercialize is within Acorda’s sole discretion and that such decision is not subject to review or dispute by Elan through the Committee nor is subject to the arbitration provisions set out in Section 12.14 of the License Agreement. Acorda shall promptly disclose any agreed key financial terms of any commercialization agreement with the Non-Elan Developer to Elan, which Elan shall maintain as confidential under the confidentiality provisions of Section 12.1 of the License Agreement.
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4.4
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Subject to the foregoing and to the other terms and conditions of this Agreement, Acorda shall be entitled, through itself or any sublicensees, to select and commercialize one Non-Elan Development Product meeting the Selection Criteria.
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4.5
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Acorda shall afford Elan a reasonable opportunity to develop any other formulations containing Compound or Alternate Compound not covered by this Agreement. For the avoidance of any doubt, nothing in this Agreement shall be deemed to constitute (i) Elan’s consent to the commercialisation of any other subsequent Non-Elan Development Product nor any Non-Elan Development Product that meets different selection criteria or (ii) a limitation on Acorda’s existing development rights under Section 12.15 of the License Agreement.
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4.6
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Where Acorda elects to commercialize a Non-Elan Development Product, Acorda and Elan shall generally coordinate and manage their business relationship relating to the commercialization of the Non-Elan Development Product through the Committee that is referred to in Article 10 of the License Agreement. The Committee shall also resolve any disputed issues (excluding any issues which may arise over Acorda’s formulation selection under Clause 4.3 or ceasing to develop or not developing Development Product under Clause 3.1) that may arise between the Parties per Section 10.3 of the License Agreement
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including submission to arbitration under Article 12.14. Through the Committee, Acorda shall keep Elan reasonably informed of those matters relating to the Non-Elan Development Product which reasonably affect Elan’s interests, including the general progress of development, objectives for and commercial performance of the Non-Elan Development Product, clinical and regulatory filings, sales performance and sales forecasts and any actual or threatened litigation or “paragraph IV certifications” pertaining to the Non-Elan Development Product.
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4.7
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Elan hereby grants to Acorda a non-exclusive, non-transferable (other than to a lawful assignee of the License Agreement) license (the “Compound Know-How and First Product Know-How License”) under the Compound Know-How and First Product Know-How to develop, package, use, import, export, make and have made (subject to Clause 10) Non-Elan Development Product in the Territory and, in addition, to promote, distribute, market, offer for sale and sell the one particular Non-Elan Development Product (if any) that Acorda finally selects to commercialize under this Clause 4 in the Territory. The part of Compound Know-How and First Product Know-How License that enables Acorda to promote, distribute, market, offer for sale and sell any finally selected Non-Elan Development Product shall be sub-licensable to Acorda’s existing sublicensee without Elan consent and to other sublicensees in accordance with the terms as set out in Section 2.3 of the License Agreement for Product; provided that in each case such entitiy is responsible for commercializing Non-Elan Development Product. Acorda and any sublicensee it appoints to commercialize Non-Elan Development Product shall only share Compound Know-How and First Product Know-How with Non-Elan Developers other than itself on a strictly need-to know-basis. This Compound Know-How and First Product Know-How License shall commence as of the Effective Date and shall end upon the expiry of Acorda’s obligations to make payments to Elan in respect of the Non-Elan Development Product, and subject to such payments being duly made shall be irrevocable during that period.
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4.8
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For clarity, the foregoing provisions shall not be construed as conferring any right or license to use any intellectual property arising from Further Development Plan activities developed solely by Elan or jointly with Elan in connection with the development, manufacture or sale of a Non-Elan Development Product, nor as conferring any liability or obligations on Elan with respect to a Non-Elan Development Product other than as expressly set out Clause 4.7 and in the Non-Elan Development Product Supply Agreement and/or other agreement(s) entered into relating to the supply of Non-Elan Development Product by Elan entered into pursuant to Clause 10 (if any).
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5.
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Manufacture and Supply of Pre-Commercial Batches of Development Product
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5.1
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Elan shall use commercially reasonable efforts to manufacture and supply to Acorda such quantity of the Development Product as it may reasonably require to perform its activities under the Further Development Plan and each applicable Work Plan.
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5.2
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Per Section 3.4 of the License Agreement, supply of Development Product shall be EXW such facility as may be specified in the applicable Work Plan or as Elan may nominate and Acorda shall reasonably approve [*****].
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5.3
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Acorda’s requests for Development Product shall clearly specify whether such use is for pre-clinical or clinical supply. Where Acorda requests Development Product for clinical
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supply, Elan shall manufacture it in accordance with phase specific cGMPs in addition to applicable laws and regulations.
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5.4
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Clauses 13.2 to 13.8 inclusive of the Supply Agreement (liability) shall apply mutatis mutandis in respect of the supply of pre-commercial supplies of Development Product.
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6.
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Registration
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6.1
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Acorda shall be responsible, at its own expense, for conducting such pre-clinical and clinical studies as are required to obtain Regulatory Approval for the Development Product. Elan shall reasonably cooperate with Acorda in obtaining such approvals at Acorda’s expense.
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6.2
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Elan will prepare and utilize a DMF (or similar structure for international filings) at Acorda’s expense for the Development Product and Acorda shall have a right of reference to the extent required by any regulatory jurisdiction until such time, if any, as Acorda terminates all development programs related to Non-Elan Development Product. Upon receipt of notice of such termination, Elan will discontinue use of the DMF and promptly provide the relevant CMC information to Acorda in support of Acorda’s regulatory filing(s), at Acorda’s expense and otherwise in accordance with the provisions of Section 3.8 of the License Agreement.
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7.
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Additional Financial Provisions
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7.1
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Development Fees for Development Product. Acorda shall pay to Elan fees in respect of Elan's activities under this Agreement at a rate of FTE plus [*****], invoiced and payable monthly. Each invoice shall identify the particular work requested by Acorda and performed by Elan under the Work Plan(s) and Further Development Plan(s), as applicable. Further, the provisions of Sections 5.1.3 (development records) and 5.1.4 (third party development costs) of the License Agreement shall apply mutatis mutandis; provided, however, that in reference to third party development costs Elan shall have the right to charge Acorda for the time spent by Elan employees in administering the work conducted by such third parties at [*****] as well as the third party development costs incurred by Elan.
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7.2
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Non-Elan Development Product Compensation. Notwithstanding any contrary provision of the License Agreement, in consideration of Elan’s agreement to permit Acorda to commercialize the Non-Elan Development Product on the terms and conditions herein and in consideration of the grant of the Compound Know-How and First Product Know-How License, Acorda shall pay to Elan:
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7.2.1
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[*****];
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7.2.2
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[*****];
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7.2.3
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[*****]; and
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7.2.4
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[*****];
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7.3
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Application of Rush Payments Agreement. For the avoidance of doubt, Acorda shall remain responsible to make payments to Elan under the Rush Payments Agreement in respect of the Development Product or the Non-Elan Development Product, as applicable, on the basis that “NSP” as used therein refers to such products respectively.
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7.4
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Ancillary.
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7.4.1
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Section 5.9 of the License Agreement (payments, reports and records) shall apply in respect of the Non-Elan Development Product mutatis mutandis.
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7.4.2
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Payments under Clause 7.2.1 shall be made upon provision of the Statement;
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7.4.3
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7.4.4
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In respect of payments under Clause 7.2.4 [*****], Sections 5.3.2 to 5.3.5 (payment terms) of the License Agreement shall apply mutatis mutandis.
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8.
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Application of License Agreement
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8.1
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Intellectual Property. At appropriate times during the Term and from time to time, Elan and Acorda shall prepare revised schedules of Elan Patent Rights and Acorda Patent Rights, reflecting such patents and patent applications as are incorporated and/or used in the Development Product.
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8.2
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License Provisions. For the purpose of clarification, Elan and Acorda agree that:
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8.2.1
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the reference in the definition of “Elan Patent Rights” to the infringement by the manufacture, use or sale of the Product is to be read as a reference to infringement by the manufacture, use or sale of the First Product or the Development Product ; and
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8.2.2
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the references in the definition of “Elan Patent Rights” and “Elan Know How” to development “in connection with the Project” is to be read as if it additionally referred to development pursuant to this Agreement.
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8.3
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Regulatory Expressions. The definitions of “NDA”, “NDA Approval”, “Regulatory Approval”, and terms referring to those defined terms shall be construed as they relate to the First Product or the Development Product, as applicable.
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8.4
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Diligence. Subject to Acorda’s formulation selection right under Clause 4.3, Section 2.11 (Diligence) of the License Agreement shall apply in respect of the Non-Elan Development Product mutatis mutandis. In performing its obligations under Section 2.11 of the License Agreement, Acorda shall be entitled to select a commercially reasonable strategy determining the priority as between the First Product on the one hand and the Development Product or Non-Elan Development Product, as the case may be, on the other.
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8.5
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Royalties. In the event that (a) the Development Product is being commercially sold and (b) Elan is manufacturing one, but not both, of the First Product and the commercially sold Development Product, the Elan Royalty specified in Section 5.6 of the License Agreement shall be calculated separately for the First Product and the Development Product.
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8.6
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Committee. Article 10 (Committee) of the License Agreement shall be read as if it additionally referred to the Further Development Plan and its budget as appropriate. For clarity, nothing in this Agreement is intended to expand upon the oversight responsibility of the Committee with respect to Product as set forth in Article 10 of the License Agreement.
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9.
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Development Product Supply Agreement
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9.1
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Not less than eighteen (18) months prior to the anticipated date of commercial launch of the Development Product, Elan and Acorda shall negotiate in good faith an amendment to the Supply Agreement or a new substantially similar supply agreement in respect of such Development Product (“Development Product Supply Agreement”), which Development Product Supply Agreement shall contain the financial terms set out in this Agreement and any other provisions of this Agreement that pertain to the Development Product, together with one or more quality agreements as appropriate. The decision as to whether to amend the existing Supply Agreement or to create a substantially similar supply agreement for Development Product shall be decided by the Committee.
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9.2
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The price of the Development Product manufactured by Elan under the applicable Development Product Supply Agreement (or under the applicable amendment to the Supply Agreement) shall [*****]. The foregoing shall be in lieu of the price stated in Clauses 9.3 and 9.4 of the Supply Agreement.
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9.3
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Elan shall enable the use of a mutually agreed independent second source for manufacture of the Development Product upon terms substantially similar set out in Clause 7 of the Supply Agreement, as agreed upon by the Committee and as set out in the Development Product Supply Agreement.
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9.4
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Except as set out in this Clause 9, as may be operationally necessary for the manufacture of a Development Product, or as may otherwise be agreed by Elan and Acorda in the Development Product Supply Agreement, the terms of the Development Product Supply Agreement shall be the same as those set out in the Supply Agreement.
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10.
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Non-Elan Development Product Supply Option
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10.1
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In the event that Acorda, chooses to commercialize a Non-Elan Development Product in accordance with Clause 4.4 of this Agreement, Elan shall have the first option to manufacture or have manufactured by an Affiliate all or a portion of the selected Non-Elan Development Product.
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10.2
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Within forty-five (45) days of the decision to proceed to commercialization of a Non-Elan Development Product (a “Non-Elan Party Election”), Acorda shall notify Elan in writing, and shall procure that Elan is provided within that period with such information as would normally be made available to a third party manufacturer together with such other information as Elan may reasonably request for the purpose of determining whether it wishes to undertake such manufacture. To this end, Acorda shall procure that the applicable Non-Elan Developer is made available and with Acorda in attendance and shall cooperate fully to answer queries which Elan may have in this regard, subject to the terms of a three-way confidential disclosure agreement to be entered into between Acorda, Elan and the Non-Elan Developer.
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10.3
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Within ninety (90) days of receipt of all such requested information, Elan shall notify Acorda in writing whether it is willing to and believes that it is able to manufacture such Non-Elan Development Product, and the portion of the Non-Elan Development Product it wishes to manufacture. If Elan does not so notify Acorda within that period, and to the extent of the portion which Elan is not willing to or does not believe that it will be able to manufacture, Acorda shall be entitled (but not obliged) to have such Non-Elan Development Product manufactured elsewhere.
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10.4
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In the event that Elan agrees to and is able to manufacture such Non-Elan Development Product:
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10.4.1
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Elan and Acorda shall negotiate in good faith the terms and conditions of, and enter into, a supply agreement consistent with this Clause 10 and otherwise with (a) non-financial terms similar to those contained in the Supply Agreement, to the extent feasible, and (b) the financial terms set out in Clause 7.2.2 (“Non-Elan Development Product Supply Agreement”); and
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10.4.2
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Elan shall and Acorda shall procure that the Non-Elan Developer negotiates in good faith a technology transfer agreement and plan for the purposes of enabling Elan to manufacture the Non-Elan Development Product. Each party shall be responsible for its own costs of all such activities and Acorda shall be responsible for any costs or expenses that may be invoiced by the Non-Elan Developer. Acorda shall be responsible at its own cost for obtaining for Elan all intellectual property rights and licenses required to undertake such manufacture.
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10.5
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Elan shall maintain the right to protect and control any confidential or proprietary data of Elan as set forth in the License Agreement or any applicable confidentiality or other agreement which may be entered into by Elan.
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11.
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Term and Termination
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11.1
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This Agreement shall commence on the Effective Date and shall continue in force until the expiry or termination of the License Agreement, howsoever arising, unless terminated earlier as set forth herein. In the event that any of the terms or provisions hereof are incurably breached by either Party, the non-breaching Party may immediately terminate this Agreement by written notice. In the event of any other breach, the non-breaching Party may terminate this Agreement by the giving of written notice to the breaching Party that this Agreement will terminate on the sixtieth (60th) day from notice unless cure is sooner effected. If the breaching Party has proposed a course of action to rectify the
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breach and is acting in good faith to rectify same but has not cured the breach by the sixtieth (60th) day, the said period shall be extended, at the sole discretion of the non-breaching party, by such period as is reasonably necessary to permit the breach to be rectified.
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11.2
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11.3
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Upon Acorda’s notice to Elan of a Non-Elan Party Election, Elan’s and Acorda’s obligations in respect of those Work Plans concerning the Development Product not selected shall automatically terminate, subject to Clause 11.4 below.
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11.4
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Upon expiry or termination of this Agreement or upon the termination of obligations in respect of specific Work Plans, Elan shall provide Acorda with an timely estimate of any wind down costs and Acorda shall be responsible for:
|
11.4.1
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payment in full for all work conducted by Elan under this Agreement (and authorized under the Further Development Plan and/or, as applicable, the specific Work Plans) up to the effective date of termination and the wind down costs of all terminated WorkPlan and Further Development Plan activities; and
|
11.4.2
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all uncancellable out of pocket costs reasonably incurred or committed prior to the effective date of termination by Elan in contemplation of the applicable Work Plan(s) and/or terminated Further Development Plan.
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11.5
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Clause 8 shall remain in force until expiry or termination of the License Agreement and Clause 3.7 shall remain in force indefinitely.
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11.6
|
On a country by country basis, in respect of the Development Product, the following provisions shall continue in force until the latest of the following dates (the “Development Product End Date”):
|
(a)
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ten (10) years starting from the date of First Commercial Sale of the Development Product in that country;
|
(b)
|
the expiry of the last to expire patent or patent application included in the Elan Patent Rights in that country;
|
(c)
|
the date on which no Elan Know-How remains capable of enforcement against third parties;
|
(d)
|
the loss of regulatory exclusivity in respect of the Development Product in that country; and
|
(e)
|
the existence of Competition in that country –
|
11.7
|
On a country by country basis, in respect of the Non-Elan Development Product selected for commercialisation, the provisions referred to below shall continue in force until the latest of the following dates (the “Non-Elan Product End Date”):
|
(a)
|
ten (10) years starting from the date of First Commercial Sale (as said term is defined in the License Agreement but in reference to Non-Elan Development Product rather the Product) of that Non-Elan Development Product in that country;
|
(b)
|
the expiry of the last to expire patent or patent application covering such Non-Elan Development Product which Acorda or any Affiliate or Designee owns, licenses or controls;
|
(c)
|
the date on which no knowledge, information, trade secrets, data or expertise covering such Non-Elan Development Product which Acorda or any Affiliate or Designee owns, licenses or controls remains capable of enforcement against third parties;
|
(d)
|
the loss of regulatory exclusivity in respect of such Non-Elan Development Product in that country; and
|
(e)
|
the existence of Competition in that country
|
11.8
|
Acorda and its Affiliates will not directly or indirectly market as a prescription medicine any other sustained release oral dosage form or transdermal form, containing the Compound or any other mono- or di-aminorpyridine active agent, other than Product (including a Development Product), or the one Non-Elan Development Product (if any) selected for commercialisation, during the period in which Acorda has an obligation to make payments to Elan under this Agreement and for one year thereafter. The foregoing shall be in addition to the restrictions contained in Section 2.2 of the License Agreement, but for the purposes of that Section such selected Non-Elan Development Product shall not be considered an “Acorda Competing Product”. For the avoidance of doubt this Clause 11.8 shall survive termination of this Agreement.
|
12.
|
Warranties
|
12.1
|
it has the right to enter into this Agreement and perform its obligations under it;
|
12.2
|
there are no agreements between that party and any third party that conflict or may conflict with this Agreement; and
|
12.3
|
it does not require any consents from any third party to enter into and/or perform its obligations under this Agreement, including in the case of Acorda, from its sub-licensee
|
13.
|
Confidentiality
|
14.
|
Assignment
|
14.1
|
Either party may assign this Agreement to any person or entity to whom it could properly assign its rights and obligations under the License Agreement.
|
14.2
|
Except as set out above, neither party may assign this Agreement without the prior written consent of the other party
|
15.
|
General
|
15.1
|
Limitation of Liability. UNLESS RESULTING FROM A PARTY’S WILLFUL MISCONDUCT OR FROM A PARTY’S BREACH OF CLAUSE 13 OF THIS AGREEMENT (ARTICLE 12.1 OF THE LICENSE AGREEMENT) OR AS MAY BE EXPRESSLY SET FORTH IN THE DEVELOPMENT SUPPLY AGREEMENT OR THE NON-ELAN DEVELOPMENT PRODUCT SUPPLY AGREEMENT, AS APPLICABLE, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY, PUNITIVE, MULTIPLE OR OTHER INDIRECT DAMAGES, OR FOR LOSS PROFITS, LOSS OF DATA, LOSS OF REVENUE OR LOSS OF USE DAMAGES, ARISING FROM OR RELATING TO THIS AGREEMENT OR THE DEVELOPMENT PRODUCT SUPPLY AGREEMENT OR THE NON-ELAN DEVELOPMENT PRODUCT SUPPLY AGREEMENT, WHETHER BASED UPON WARRANTY, CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS CLAUSE 15.1 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER THIS AGREEMENT, THE DEVELOPMENT PRODUCT SUPPLY AGREEMENT OR THE NON-ELAN DEVELOPMENT PRODUCT SUPPLY AGREEMENT.
|
15.2
|
Method of Calculation of Payments. The parties acknowledge and agree that the methods for calculating the royalties, fees, supply prices, compensating payments and other payments under this Agreement and under the License Agreement (as interpreted in accordance with this Agreement), Supply Agreement, Development Product Supply Agreement (if any) and Non-Elan Development Product Supply Agreement (if any), are for the convenience of the parties, are freely chosen and not coerced.
|
15.3
|
Parties Bound: This Agreement shall be binding upon and run for the benefit of the parties, their successors and permitted assigns.
|
15.4
|
Relationship of the Parties: In this Agreement, nothing shall be deemed to constitute a partnership between the parties or make either party an agent for the other, for any purpose whatsoever.
|
15.5
|
Entire Agreement: Without prejudice to the License Agreement and Supply Agreement and any other agreements incorporated by reference therein, this Agreement constitutes the entire agreement and understanding between the parties with respect to its subject matter. Except as expressly provided, this Agreement supersedes all prior representations, writings, negotiations or understandings with respect to that subject matter. The parties
|
acknowledge that, in entering into this Agreement, they have not relied on, and shall have no right or remedy in respect of, any statement, representation, assurance or warranty (whether made negligently or innocently) other than as expressly set forth in this Agreement. Nothing in this clause shall limit or exclude any liability for fraud.
|
15.6
|
Severability: If any provision in this Agreement is deemed to be, or becomes invalid, illegal, void or unenforceable under applicable laws, such provision will be deemed amended to conform to applicable laws so as to be valid and enforceable, or if it cannot be so amended without materially altering the intention of the parties, it will be deleted, but the validity, legality and enforceability of the remaining provisions of this Agreement shall not be impaired or affected in any way.
|
15.7
|
Further Assurance: Each party shall do and execute, or arrange for the doing and executing of, each necessary act, document and thing reasonably within its power to implement this Agreement.
|
15.8
|
Counterparts: This Agreement may be executed in any number of counterparts, each of which when so executed shall be deemed to be an original and all of which when taken together shall constitute this Agreement.
|
15.9
|
Waivers: A failure to exercise or delay in exercising a right or remedy provided by this Agreement or by law does not constitute a waiver of the right or remedy or a waiver of other rights or remedies. No single or partial exercise of a right or remedy provided by this Agreement or by law prevents further exercise of the right or remedy or the exercise of another right or remedy.
|
15.10
|
Variations. No modification, amendment, or waiver of any provision of this Agreement shall be valid unless in writing and signed by a duly authorised officer or representative of each of the parties hereto.
|
15.11
|
Notices:
|
15.11.1
|
Elan and Acorda hereby acknowledge that pursuant to Section 12.12.1 of the License Agreement, the following addresses, fax numbers and contact names shall apply in lieu or those originally stated therein:
|
(a)
|
in the case of Elan (which constitutes notice):
|
(b)
|
in the case of Acorda (which constitutes notice) :
|
|
With a copy (receipt of which shall not constitute notice) to the attention of: General Counsel, at the same address
|
15.11.2
|
Subject to those changes, Section 12.12 of the License Agreement shall apply to any notice required under this Agreement as if set out in full.
|
15.12
|
Governing Law and Arbitration: This Agreement is construed under and ruled by the laws of the State of New York, excluding its conflict of laws rules. For the purpose of this Agreement, the Parties submit to the jurisdiction of the United States District Court for the State of New York. Section 12.14 of the License Agreement (arbitration) is hereby incorporated as if it were set out at length herein and is applicable to Non-Elan Development Product as provided herein, and reading references in that Clause to Article 10 of the License Agreement (Committee) as interpreted in accordance with this Agreement.
|
|
/s/ William F. Daniel
|
|
Duly authorised for and on behalf of
|
|
ELAN PHARMA INTERNATIONAL LIMITED
William F. Daniel
|
|
/s/Ron Cohen
|
|
Duly authorised for and on behalf of
|
|
ACORDA THERAPEUTICS, INC.
Ron Cohen, M.D.
|
Duly authorised for and on behalf of
Elan Pharma International Ltd.
By:____________________________
|
Duly authorised for and on behalf of
Acorda Therapeutics, Inc.
By:____________________________
|
Name:
Title:
Date:
|
|
Name:
Title:
Date:
|
·
|
The new formulation must be assessed [*****]
|
·
|
Timing: [*****].
|
·
|
Cost: [*****].
|
3.
|
The following provision is hereby added to Article 3 of the Agreement:
|
(a)
|
If no patent term extension is granted on a Licensed Patent, then until the later of:
|
i.
|
the expiry of the last Licensed Patent in such country; or
|
ii.
|
[*****] after the first commercial Sale of a Licensed Product in such country.
|
(b)
|
If a patent term extension is granted on a Licensed Patent, then until the expiry of the last Licensed Patent in such country.
|
CAMBRIDGE ENTERPRISE LIMITED
|
ACORDA THERAPEUTICS, INC.
|
By: /s/ Dr. R.C. Jennings
Name: Dr. R.C. Jennings
Title: Director
|
By: /s/ Ron Cohen
|
Date: 9/2/11
|
Date: 3/4/11
|
KINGS COLLEGE LONDON
|
By: /s/ Mike Shaw, PhD.
Name: Mike Shaw, Ph.D.
Title: Commercial Director
King’s College London Business Ltd.
For and on behalf of King’s College London
|
Date: 21/2/11
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Acorda Therapeutics, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
(b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
/s/ Ron Cohen
|
|
Ron Cohen
Chief Executive Officer
(Principal Executive Officer)
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Acorda Therapeutics, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
/s/ David Lawrence
|
|
David Lawrence
Chief Financial Officer
(Principal Financial Officer)
|
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
|
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
|
/s/ RON COHEN
RON COHEN
Chief Executive Officer
(Principal Executive Officer)
May 9, 2011
|
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
|
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
|
/s/ DAVID LAWRENCE
DAVID LAWRENCE
Chief Financial Officer
(Principal Financial Officer)
May 9, 2011
|
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