As filed with the Securities and Exchange Commission on January 25, 2006
Registration No. 333-128827
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
AMENDMENT NO. 5 TO
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
ACORDA THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware | 2836 | 13-3831168 | ||
(State or Other Jurisdiction of
Incorporation or Organization) |
(Primary Standard Industrial
Classification Code Number) |
(I.R.S. Employer Identification Number) |
15 Skyline Drive
Hawthorne, New York 10532
(914) 347-4300
(Address, Including Zip Code, and Telephone Number,
Including Area Code, of Registrant's Principal Executive Offices)
Ron Cohen
Chief Executive Officer
15 Skyline Drive
Hawthorne, New York 10532
(914) 347-4300
(Name, Address, Including Zip Code, and Telephone Number,
Including Area Code, of Agent For Service)
Copy To:
Ellen B. Corenswet
Covington & Burling 1330 Avenue of the Americas New York, New York 10019 (212) 841-1000 |
Danielle Carbone
Shearman & Sterling LLP 599 Lexington Avenue New York, New York 10022 (212) 848-4000 |
Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this Registration Statement.
If the securities being registered on this form are being offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. o
If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
If delivery of the prospectus is expected to be made pursuant to Rule 434 under the Securities Act, please check the following box. o
The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, or until this registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
Explanatory Note:
This Amendment No. 5 to the registration statement on Form S-1 of Acorda Therapeutics, Inc. is filed solely for the purpose of filing the following exhibits: Exhibit 10.14; Exhibit 10.15; Exhibit 10.16; Exhibit 10.18; Exhibit 10.19; Exhibit 10.20; Exhibit 10.21; Exhibit 10.22; Exhibit 10.23; Exhibit 10.24; Exhibit 10.25; Exhibit 10.26; Exhibit 10.27; Exhibit 10.28; Exhibit 10.29; Exhibit 10.32; Exhibit 10.38; Exhibit 10.40; and Exhibit 10.41.
Part II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 13. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth our estimated costs and expenses (other than underwriting discounts) payable in connection with this offering.
SEC Registration Fee | $ | 10,152.00 | ||
NASD Filing Fee | 9,125.00 | |||
Nasdaq National Market Listing Fee | 5,000.00 | |||
Printing and Engraving Expenses | 375,000.00 | |||
Legal Fees and Expenses | 900,000.00 | |||
Accounting Fees and Expenses | 750,000.00 | |||
NASD-related Legal Fees and Expenses | 20,000.00 | |||
Transfer Agent and Registrar Fees and Expenses | 20,000.00 | |||
Miscellaneous | 10,000.00 | |||
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Total | $ | 2,099,277.00 | ||
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ITEM 14. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Acorda Therapeutics, Inc., or the Registrant, is a Delaware corporation. Section 145 of the Delaware General Corporation Law, or the DGCL, grants each corporation organized thereunder the power to "indemnify any person who is or was a director, officer, employee or agent of a corporation or enterprise, against expenses, attorneys' fees, judgments, fines and amounts paid in settlement actually and reasonably incurred by him in connection with any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative, other than an action by or in the right of the corporation, by reason of being or having been in any such capacity if he acted in good faith in a manner reasonably believed to be in or not opposed to the best interests of the corporation, and, with respect to any criminal action or proceeding, had no reasonable cause to believe his conduct was unlawful."
Section 102(b)(7) of the DGCL enables a corporation in its certificate of incorporation or an amendment thereto to eliminate or limit the personal liability of a director to the corporation or its stockholders for monetary damages for violations or the directors' fiduciary duty of care, except (i) for any breach of the director's duty of loyalty to the corporation or its stockholders, (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (iii) pursuant to Section l74 of the DGCL (providing for liability of directors for unlawful payment of dividends or unlawful stock purchases or redemptions) or (iv) for any transaction from which a director derived an improper personal benefit.
Article Six of the Registrant's Amended and Restated Certificate of Incorporation (filed as Exhibit 3.1) provides that except as otherwise provided by the DGCL, no director of the Registrant shall be personally liable to the Registrant or its stockholders for monetary damages for breach of fiduciary duty as a director.
Article Six of the Registrant's Amended and Restated Certificate of Incorporation and Article Six of the Registrant's Amended Bylaws provide that, to the fullest extent permitted by the DGCL, the Registrant shall indemnify any current or former director or officer of the Registrant and may, at the discretion of the Board of Directors, indemnify any current or former employee or agent of the Registrant against all expenses (including attorneys' fees) judgments, fines and amounts paid in settlement actually and reasonably incurred in connection with any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact
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that he or she is or was a director or officer of the Registrant, or is or was serving as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise.
Article Six of the Registrant's Amended and Restated Certificate of Incorporation also provides that the Registrant shall advance expenses incurred by a director or officer of the Registrant in defending any civil, criminal, administrative or investigative such action, suit or proceeding in advance of the final disposition of such action, suit or proceeding upon receipt of an undertaking by or on behalf of such director or officer to repay such advances if it shall ultimately be determined that he is not entitled to be indemnified by the Registrant as authorized by the Registrant's By-laws. In addition, upon the closing of this offering, our amended and restated certificate of incorporation (filed as exhibit 3.2) will provide that if a claim under the Registrant's By-laws is not paid in full by the Registrant within thirty days after a written claim has been received by the Registrant, the claimant may at any time thereafter bring suit against the Registrant to recover the unpaid amount of the claim, and if successful in whole or in part on the merits or otherwise in establishing his or her right to indemnification or to the advancement of expenses, the claimant shall be paid also the expense of prosecuting such claim.
ITEM 15. RECENT SALES OF UNREGISTERED SECURITIES
Within the past three years, the Registrant has issued securities in the following transactions, each of which was exempt from the registration requirements of the Securities Act of 1933, as amended, as transactions by an issuer not involving any public offering thereunder. All of the below-referenced securities are deemed restricted securities for the purpose of the Securities Act.
In May 2003, we consummated a private placement of 112,790,233 shares of our Series J Convertible Preferred Stock to a group of accredited investors at a purchase price of $0.49 per share for aggregate consideration of approximately $55,267,000.
In March 2004, we consummated a private placement of 1,533,330 shares of our Series K Convertible Preferred Stock to a group of accredited investors at a purchase price of $7.50 per share for aggregate consideration of approximately $11,499,958.
Stock Options
In the fourth quarter of 2002, we issued options to purchase 2,218 shares of our common stock with a fair market value price of $2.60 to a number of our employees.
In the first quarter of 2003, we issued options to purchase 5,465 shares of our common stock with a fair market value price of $2.60 to a number of our employees. We also issued 1,282 options to purchase our common stock with a fair market value price of $2.60 to a non-employee director.
In the second quarter of 2003, we issued options to purchase 288 shares of our common stock with a fair market value price of $2.60 to a number of our employees.
In the third quarter of 2003, we issued options to purchase 1,062,081 shares of our common stock with a fair market value price of $2.60 to a number of our employees.
In the fourth quarter of 2003, we issued options to purchase 48,077 shares of our common stock with a fair market value price of $2.60 to a number of our employees. We also issued 1,924 options to purchase our common stock with a fair market value price of $2.60 to a number of non-employees.
In the first quarter of 2004, we issued options to purchase 17,192 shares of our common stock with a fair market value price of $9.75 to a number of our employees. We also issued 1,912 options to purchase our common stock with a fair market value price of $7.64 to a number of employees.
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In the third quarter of 2004, we issued options to purchase 3,769 shares of our common stock with a fair market value price of $9.75 to a number of our employees.
In the fourth quarter of 2004, we issued options to purchase 44,615 shares of our common stock with a fair market value price of $9.75 to a number of our employees.
In the first quarter of 2005, we issued options to purchase 34,615 shares of our common stock with a exercise price of $8.14 to a number of our employees.
In the third quarter of 2005, we issued options to purchase 548,484 shares of our common stock with a exercise price of $8.14 to a number of our employees. We also issued 32,699 options to purchase our common stock with a exercise price of $8.14 to a non-employee director.
In the fourth quarter of 2005, we issued options to purchase 3,461 shares of our common stock with an exercise price of $8.14 to a number of our employees.
Restricted Shares
On March 9, 2004, and August 6, 2004, we issued 1,134,393 and 5,077 restricted shares, respectively, to a number of our employees.
On August 3, 2005, we issued 7,692 restricted shares to two of our non-employee directors.
Warrants
On January 28, 2005, in connection with entering into our senior secured term loan with GE Capital, we issued to GE Capital a warrant to purchase up to $300,000 worth of shares of our preferred stock (or, if we have consummated our initial public offering, shares of our common stock) in an amount and at a price to be determined pursuant to the terms thereof.
ITEM 16. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) Exhibit Index
A list of exhibits filed with this registration statement on Form S-1 is set forth on the Exhibit Index and is incorporated in this Item 16(a) by reference.
(b) Financial Statement Schedules
None
ITEM 17. UNDERTAKINGS
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrants have been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.
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(1) The undersigned registrant hereby undertakes to provide to the underwriter at the closing specified in the underwriting agreements, certificates in such denominations and registered in such names as required by the underwriter to permit prompt delivery to each purchaser.
(2) The undersigned registrant hereby undertakes that:
(a) For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration statement as of the time it was declared effective.
(b) For purposes of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offering therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
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Pursuant to the requirements of the Securities Act, the Registrant has duly caused this Amendment to Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of New York, State of New York, on January 25, 2006
By: |
/s/
RON COHEN
Ron Cohen, President and Chief Executive Officer |
Pursuant to the requirements of the Securities Act of 1933, as amended, this Amendment to Registration Statement has been signed by the following persons in the capacities and on the dates indicated:
Signature
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/s/
RON COHEN
Ron Cohen, M.D. |
President, Chief Executive Officer and Director (Principal Executive Officer) | January 25, 2006 | ||||
/s/ DAVID LAWRENCE David Lawrence, M.B.A. |
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Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) |
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January 25, 2006 |
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* Standish M. Fleming, M.B.A. |
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Director |
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January 25, 2006 |
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* John H. Friedman, J.D. |
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Director |
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January 25, 2006 |
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* Sandra Panem, Ph.D. |
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Director |
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January 25, 2006 |
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* Barclay A. Phillips |
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Director |
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January 25, 2006 |
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* Mark R.E. Pinney, M.B.A., C.F.A., M.Sc. |
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Director |
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January 25, 2006 |
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* Lorin J. Randall |
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Director |
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January 25, 2006 |
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* Steven M. Rauscher, M.B.A. |
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Director |
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January 25, 2006 |
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* Michael Steinmetz, Ph.D. |
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Director |
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January 25, 2006 |
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* Wise Young, Ph.D., M.D. |
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Director |
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January 25, 2006 |
*By: |
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/s/ RON COHEN Ron Cohen Attorney-in-fact |
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Exhibit No.
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Description
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1.1 |
** |
Form of Underwriting Agreement |
3.1 |
* |
Amended and Restated Certificate of Incorporation |
3.2 |
* |
Amended Bylaws |
3.3 |
* |
Form of Post-IPO Amended and Restated Certificate of Incorporation |
3.4 |
* |
Form of Post-IPO Amended Bylaws |
3.5 |
* |
Amendment No. 1 to Amended and Restated Certificate of Incorporation |
3.6 |
* |
Amendment No. 2 to Amended and Restated Certificate of Incorporation |
4.1 |
* |
Specimen Stock Certificate |
4.2 |
* |
Warrant to purchase 100,000 shares of Series B Preferred Stock, $2.00 par value per share, dated February 4, 2002, issued by the Registrant to Elan International Services, Ltd. |
4.3 |
* |
Warrant to purchase 40,000 shares of common stock, $0.10 par value per share, dated May 1, 1996, issued by the Registrant to Mark Noble and Margo Meyer |
4.4 |
* |
Warrant to purchase $300,000 worth of Warrant Shares, dated January 28, 2005, issued by the Registrant to General Electric Capital Corporation |
5.1 |
** |
Opinion of Covington & Burling |
10.1 |
* |
Acorda Therapeutics 1999 Employee Stock Option Plan |
10.2 |
* |
Amendment to 1999 Employee Stock Option Plan |
10.3 |
* |
Amendment No. 2 to 1999 Employee Stock Option Plan |
10.4 |
* |
Acorda Therapeutics 2006 Employee Incentive Plan |
10.5 |
* |
Acorda Therapeutics 2006 Employee Incentive Plan, as amended as of January 13, 2005 |
10.6 |
* |
Sixth Amended and Restated Registration Rights Agreement, dated March 3, 2004, by and among the Registrant and certain stockholders named therein |
10.7 |
* |
Employment Agreement, dated August 11, 2002, by and between the Registrant and Ron Cohen |
10.8 |
* |
Amendment to August 11, 2002 Employment Agreement, dated September 26, 2005, by and between the Registrant and Ron Cohen |
10.9 |
* |
Letter Agreement, dated November 30, 2004, by and between the Registrant and Mark Pinney |
10.10 |
* |
Employment Agreement, dated as of December 19, 2005, by and between the Registrant and Andrew R. Blight |
10.11 |
* |
Employment Agreement, dated as of December 19, 2005, by and between the Registrant and Mary Fisher |
10.12 |
* |
Employment Agreement, dated as of December 19, 2005, by and between the Registrant and David Lawrence |
10.13 |
* |
Employment Agreement, dated as of December 19, 2005, by and between the Registrant and Jane Wasman |
10.14 |
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Amended and Restated License Agreement, dated September 26, 2003, by and between the Registrant and Elan Corporation, plc. |
10.15 |
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Supply Agreement, dated September 26, 2003, by and between the Registrant and Elan Corporation, plc. |
10.16 |
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License Agreement, dated September 26, 2003, by and between the Registrant and Rush-Presbyterian-St. Luke's Medical Center |
10.17 |
* |
Side Agreement, dated September 26, 2003, by and among the Registrant, Rush-Presbyterian-St. Luke's Medical Center, and Elan Corporation, plc. |
10.18 |
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Payment Agreement, dated September 26, 2003, by and among the Registrant, Rush-Presbyterian-St. Luke's Medical Center, and Elan Corporation, plc. |
10.19 |
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Amendment No. 1 to the Payment Agreement, dated as of October 27, 2003, by and between the Registrant and Elan Corporation, plc. |
10.20 |
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Amended and Restated License Agreement, dated August 1, 2003, by and between the Registrant and Canadian Spinal Research Organization |
10.21 |
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License Agreement, dated February 3, 2003, by and between the Registrant and Cornell Research Foundation, Inc. |
10.22 |
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License Agreement, dated November 12, 2002, by and between the Registrant and CeNeS Pharmaceuticals, plc |
10.23 |
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License Agreement, dated November 12, 2002, by and between the Registrant and CeNeS Pharmaceuticals, plc |
10.24 |
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License Agreement, dated September 8, 2000, by and between the Registrant and Mayo Foundation for Medical Education and Research |
10.25 |
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Side Letter Agreement, dated June 1, 2005, by and between the Registrant and Mayo Foundation for Medical Education and Research |
10.26 |
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Asset Purchase Agreement, dated as of July 21, 2004, by and between the Registrant and Elan Pharmaceuticals, Inc. |
10.27 |
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Zanaflex Supply Agreement, dated as of July 21, 2004, by and between the Registrant and Elan Pharma International Limited |
10.28 |
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Assignment and Assumption Agreement, dated as of July 21, 2004, by and among the Registrant, Elan Pharmaceuticals, Inc., and Novartis Pharma AG |
10.29 |
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License Agreement, dated April 17, 1991, by and between Sandoz Pharma, now Novartis Pharma AG and Athena Neurosciences, Inc., now Elan Pharmaceuticals, Inc. |
10.30 |
* |
Patent Assignment Agreement, dated as of July 21, 2004, by and between the Registrant and Elan Pharmaceuticals, Inc. |
10.31 |
* |
Trademark License Agreement, dated as of July 21, 2004, by and between the Registrant and Elan Pharmaceuticals, Inc. |
10.32 |
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Agreement Relating to Additional Trademark, dated as of July 2005, by and between the Registrant and Elan Pharmaceuticals, Inc. |
10.33 |
* |
Domain Name Assignment Agreement, dated as of July 21, 2004, by and between the Registrant and Elan Pharmaceuticals, Inc. |
10.34 |
* |
Bill of Sale and Assignment and Assumption Agreement, dated as of July 21, 2004, by and between the Registrant and Elan Pharmaceuticals, Inc. |
10.35 |
* |
Limited Recourse Convertible Promissory Note issued to Elan International Services, Ltd. |
10.36 |
* |
Full Recourse Convertible Promissory Note issued to Elan International Services, Ltd. |
10.37 |
* |
Note Modification and Amendment, dated as of December 23, 2005, by and between the Registrant and Elan Pharma International Limited |
10.38 |
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Fampridine Tablet Technical Transfer Program Proposal for Commercial Registration, dated February 26, 2003, by and between the Registrant and Patheon, Inc. |
10.39 |
* |
Securities Amendment Agreement, dated September 26, 2003, by and among the Registrant, Elan Corporation plc and Elan International Services, Ltd. |
10.40 |
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Syndicated Sales Force Agreement, dated as of August 1, 2005, between the Registrant and Cardinal Health PTS, LLC |
10.41 |
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License Agreement, dated as of December 19, 2003, by and among the Registrant, Cambridge University Technical Services Limited, and King's College London |
10.42 |
* |
Promissory Note issued to General Electric Capital Corporation |
10.43 |
* |
Revenue Interests Assignment Agreement, dated as of December 23, 2005, between the Registrant and King George Holdings Luxembourg IIA S.à.r.l., an affiliate of Paul Royalty Fund II, L.P. |
21.1 |
* |
List of Subsidiaries of the Registrant |
23.1 |
* |
Consent of KPMG LLP, Independent Registered Public Accounting Firm |
23.2 |
* |
Consent of KPMG Independent Public Accounting Firm |
23.3 |
** |
Consent of Covington & Burling (included in Exhibit 5.1) |
24.1 |
* |
Power of Attorney of Standish M. Fleming, John Friedman, Sandra Panem, Barclay A. Phillips, Mark R.E. Pinney, Steven M. Rauscher, Michael Steinmetz, and Wise Young |
24.2 |
* |
Power of Attorney of Lorin J. Randall |
Exhibit 10.14
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the
Commission.
EXECUTION COPY
Date: 26, September 2003
ELAN CORPORATION, PLC.
AND
ACORDA THERAPEUTICS, INC.
AMENDED AND RESTATED LICENSE AGREEMENT
INDEX
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THIS AMENDED AND RESTATED LICENSE AGREEMENT is made as of the day of September 2003
BETWEEN:
(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 ).
RECITALS:
(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 & Ds 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.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, the Parties hereby agree that each of the MS Agreement and the SCI Agreement, and all of the terms, conditions and provisions of the MS Agreement and the SCI Agreement, are hereby superceded and replaced and restated in their entirety by this Agreement and the Supply Agreement and the terms, conditions and provisions hereof and thereof, as of the Amendment Date, as follows and as set forth in the Supply Agreement:
ARTICLE 1 DEFINITIONS AND INTERPRETATION
1.1. In the present Agreement and any further agreements based thereon between the Parties hereto, the following definitions shall prevail:
1
Acorda Know-How shall mean all knowledge, information, trade secrets, data and expertise relating to the Product which is not generally known to the public that is owned or possessed by Acorda (and/or its Affiliates), or that is developed by Acorda (and/or its Affiliates) during the term of this Agreement relating to the Product, including clinical data, whether or not covered by any patent, copyright, design, trademark or other industrial or intellectual property rights and excluding Elan Intellectual Property. Title to all inventions and other intellectual property made solely by Acorda employees in connection with the Project shall be owned by Acorda.
Acorda Patent Rights shall mean any and all rights under any and all patents and patent applications now existing, currently pending or hereafter filed, owned or acquired or licensed by Acorda (and/or its Affiliates) from a Third Party which would be infringed by the manufacture, use or sale of the Product, the current status of which is set forth in Schedule 1 . Acorda Patent Rights shall also include all continuations, continuations-in-part, divisionals and re-issues of such patents and patent applications and any patents issuing thereon and extensions of any patents licensed hereunder. Acorda Patent Rights shall further include any patents or patent applications covering any improved methods of making or using the Product invented or acquired by Acorda (and/or its Affiliates) from a Third Party during the term of this Agreement, and under which Acorda (and/or its Affiliates) has a right to grant a licence hereunder. Acorda Patent Rights shall exclude Elan Intellectual Property.
Act shall mean the United States Federal Food Drug and Cosmetic Act of 1934, and the rules and regulations promulgated thereunder, or any successor act, as the same shall be in effect from time to time.
Affiliate shall mean any corporation or entity controlling, controlled by or under the common control of Elan or Acorda as the case may be. For the purpose of this Agreement, control shall mean the direct or indirect ownership of at least fifty percent (50%) of the outstanding shares or other voting rights of the subject entity to elect directors, or if not meeting the preceding criteria, any entity owned or controlled by or owning or controlling at the maximum control or ownership right permitted in the country where such entity exists.
Agreement shall mean this amended and restated license agreement (which expression shall be deemed to include the Recitals and Appendices and Schedules hereto).
Alternate Compound shall mean any mono- or di-aminopyridine, other than the Compound, as well as the isomers, and the salts thereof.
Amendment Date shall mean September 2003.
API shall mean any Compound or Alternate Compound, in bulk form, for use as an active ingredient in the manufacture of Product.
2
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk *, have been separately filed with the Commission.
Assignment Agreement shall mean the Termination and Assignment Agreement entered into by and among Acorda, Elan and MS R & D as of the Amendment Date, a copy of which is attached hereto as Schedule 2 .
Cardinal Agreement shall mean the Laboratory Services Agreement by and between Cardinal Health PTS, Inc. (Cardinal) and Acorda dated April 1, 2003 relating to stability testing of oral tablets of Fampridine.
cGCP , cGLP and cGMP shall mean current Good Clinical Practises, current Good Laboratory Practises and current Good Manufacturing Practises, respectively, pursuant to the Act and FDA guidance documents.
CMC Section shall mean the chemistry, manufacturing, and controls section of an NDA as defined in 21 CFR Section 314.50 (1) and its equivalent in other registration applications.
Committee shall mean the committee to be established pursuant to Article 10.
Competition shall mean on a country by country basis the sale or distribution by a Third Party of a sustained release oral pharmaceutical formulation of a mono- or di-aminopyridine active agent for administration on a once or twice daily basis for the treatment or amelioration of any neurological condition(s) (including neurogenic conditions) in humans, where the sales or distribution of such formulation by said Third Party for a calendar year are at least fifteen percent (15%) of the total sales of the Product in such country in such calendar year expressed in equivalent units. The determination that Competition exists in any country in any calendar year shall be deemed conclusively if a mutually agreed reputable organization such as IMS has made such determination based on its conduct of a market share study in such country during such year, provided the existence of such level of sales of competing products may also be established by other reasonable evidence. Once a determination is made that Competition exists for a Product in any country, such determination shall be made again by the Parties each calendar year for so long as the Product is marketed in that country; provided that in the event that Competition has ceased prior to the end of a calendar year and has not resumed, the Competition shall be deemed to have terminated for such year.
Compound shall mean the compound known as 4-aminopyridine as well as the isomers, and the salts thereof.
Confidential Information shall mean (i) any proprietary or confidential information or material in tangible form disclosed hereunder that is marked as Confidential at the time it is delivered to the receiving Party, or (ii) proprietary or confidential information disclosed orally hereunder which is identified as confidential or proprietary when disclosed and such disclosure of confidential information is confirmed in writing within thirty (30) days by the disclosing Party.
Designee shall mean a sub-licensee, distributor or any other Third Party authorised by Acorda including those entities or persons appointed by Acorda pursuant to the provisions of Article 2.3.1.
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Development Plan shall have the meaning set forth in Article 3.1.
DMF shall mean a Drug Master File, as defined in 21 CFR Section 314.420, as the same may be amended or re-promulgated from time to time, or any successor filing or procedure and/or its equivalent in the other countries of the Territory.
Dominating Patent shall mean an unexpired patent that has not been invalidated by a court or governmental agency which is owned by a Third Party, which covers the Product sold by Acorda or its Designees, under circumstances such that Acorda, including on behalf of its Designees, has no commercially reasonable alternative to obtaining a royalty-bearing licence under such patent in order to practise or exploit the Elan Intellectual Property to develop and/or commercialise the Product.
EDDI shall mean Elan Drug Delivery Inc., a wholly-owned subsidiary of Elan, and the successor to Elan Pharmaceutical Research Corp.
Elan Intellectual Property shall mean the Elan Patent Rights and/or the Elan Know-How.
Elan Know-How shall mean all knowledge, information, trade secrets, data and expertise within Elans oral controlled release technology relating to the Product which is not generally known to the public that is owned or possessed by Elan (and/or its Affiliates), or to be developed by Elan (and/or its Affiliates), whether before or during the term of this Agreement, whether or not covered by any patent, copyright, design, trademark or other industrial or intellectual property rights, or developed by or on behalf of Elan (and/or its Affiliates) in connection with the Project, or developed by or on behalf of Elan (and/or its Affiliates) pursuant to the Axogen Agreement. Title to all inventions and other intellectual property made solely by employees of Elan in connection with the Project shall be owned by Elan.
Elan Know-How shall exclude:
(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.
Elan Patent Rights shall mean any and all rights under any and all patents and patent applications now existing, currently pending or hereafter filed, owned or acquired or licensed by Elan (and/or its Affiliates) which would be infringed by the manufacture, use or sale of the Product, the current status of which as of the Amendment Date is set forth in Schedule 3 . Elan Patent Rights shall also include all continuations, continuations-in-part, divisionals and re-issues of such patents and patent applications and any patents
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the
Commission.
issuing thereon and extensions of any patents licensed hereunder. Elan Patent Rights shall further include any patents or patent applications covering any improved methods of making or using the Product invented or acquired by Elan (and/or its Affiliates) during the term of this Agreement and under which Elan (and/or its Affiliates) has a right to grant a licence hereunder, and Elans (and/or its Affiliates) interest in any intellectual property conceived reduced to practice or otherwise developed in connection with the Project.
EMEA shall mean the European Agency for the Evaluation of Medicinal Products based in London (UK), as established by Council Regulation n° 2309/93 of July 22, 1993, as subsequently amended by Commission Regulation 649/98 of March 23, 1998.
End of Phase 2 Meeting shall mean the first end of Phase 2 meeting with the FDA, as defined in 21 CFR Section 312.47, intended to determine the safety of proceeding to Phase 3, evaluate the Phase 3 plan and protocols and identify any additional information necessary to support an NDA for Product.
EXW and Ex Works shall have the meaning as such term is defined in the ICC Incoterms, 2000, International Rules for the Interpretation of Trade Terms, ICC Publication No. 560.
Fampridine Product shall mean any finished pharmaceutical oral sustained release dosage form containing the Compound, which is in the scope of one or more Valid Claims within the Elan Patent Rights in the country of sale, and/or incorporates Elan Know-How in material part. The use of the pre-clinical, toxicological, pharmacokinetic, metabolic, formulation, methods, clinical protocols and data developed for and on behalf of Elan, which is included in the Elan Know-How shall constitute incorporation of the Elan Know-How in material part.
FDA shall mean the United States Food and Drug Administration or any other successor agency, whose approval is necessary to market the Product in the United States of America.
First Commercial Sale shall mean the first In Market sale of Product in any country by Acorda or an Acorda Designee for end use or consumption, after all required Regulatory Approvals have been granted by the governing health authority of such country.
FTE means Elans full time equivalent charging rate for its appropriate employees or consultants from time to time (based on cost without mark-up) which as of the Amendment Date is [***] per day.
GAAP shall mean generally accepted accounting principles in the United States consistently applied.
IND shall mean the investigational new drug application and any amendments thereto for the Product filed with the FDA including IND numbers 17,627 and 51,333.
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Indication shall mean any use or indication of Product for treatment of any condition, including SCI and MS.
Initial Period shall have the meaning set forth in Article 12.5.1.1.
In Market shall mean the sale of the Product, whether by Acorda or its Designee, to an unaffiliated Third Party such as a wholesaler, distributor, managed care organisation, hospital or pharmacy and shall exclude the transfer pricing of the Product by Acorda to an Affiliate.
Joint Invention shall mean all inventions and other intellectual property made jointly by employees of Acorda and Elan in connection with the Project, which inventions and intellectual property shall be jointly owned by Elan and Acorda.
Launch Stocks shall have the meaning set forth in the Supply Agreement.
License Revenues shall mean the monetary amount or non cash consideration (exclusive of any taxes or duties that Acorda may be required by law to pay, but not including income, corporation or similar taxes) paid to Acorda for the granting to any Third Party any of the rights granted to Acorda under this Agreement and shall further include any other on going fees paid to Acorda in respect of such rights, but shall exclude bona fide research or development fees and payments received by Acorda and any payments received by Acorda for the sale of the Product from Elan pursuant to the provisions of Article 2.11.3. For the avoidance of doubt, it is understood and agreed that License Revenues shall not include and Elan shall not be entitled to receive any share of payments received from a Third Party for the purchase of equity in Acorda, debt financing, the licence of intellectual property other than the Elan Intellectual Property, rights to products other than the Product or the reimbursement of patent or other expenses incurred by Acorda; provided that License Revenues shall include and Elan shall be entitled to receive any share of payments received from a Third Party for the purchase of equity in Acorda where such payments or a portion thereof are referable to the granting of rights to the Elan Intellectual Property for the Product. The fact that a premium is paid by a Third Party for the purchase of equity in Acorda shall not of itself mean that the premium is referable to the granting of rights to the Elan Intellectual Property for the Product. For the avoidance of doubt, the Parties hereby confirm that the definition of License Revenues does not include royalties calculated as a percentage of NSP or of net In Market sales payable in each case by Designees to Acorda.
Major European Markets shall mean each of the United Kingdom, France, Germany and Italy.
Manufacturing Cost shall have the same meaning as in the Supply Agreement.
Merck Agreement shall mean the Technology Transfer and License Agreement dated 26 July 1999 between Merck & Co. Inc. ( Merck ), Elan, Elan Pharmaceutical Research Corp. (now EDDI) and Elan Pharma International Limited.
MS shall mean multiple sclerosis.
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MS Field shall mean use as an oral prescription medicine for the treatment of MS in humans.
MS R & D shall mean MS Research and Development Corporation, a Delaware corporation, having an office at 15 Skyline Drive, Hawthorne, New York 10532 USA.
MS Term shall mean shall mean the period beginning on 21 April 1998 and ending upon expiry or termination of this Agreement, howsoever arising.
NDA shall mean the new drug application as defined in the Act and applicable regulations promulgated thereunder including any supplements or amendments thereto, which Acorda may file for the Product with the FDA.
NDA Approval shall mean the final approval to market the Product by the FDA as defined under the Act.
NDA Equivalent shall mean any new registration application or submission including any supplements or amendments thereto, such as a foreign counterpart to the NDA, which Acorda may file for the Product with any regulatory authority in any regulatory jurisdiction in the Territory other than the United States that is required to obtain Regulatory Approval in such jurisdiction.
NDA Timeline shall mean the development and regulatory timeline attached hereto as Schedule 4.
Notional NSP shall mean the estimated NSP of Product at the applicable time, which shall on a country-by-country basis be provided by Acorda to the Committee within ninety (90) days prior to commencement of each calendar year (or, for the Launch Year in any country, within ninety (90) days prior to the estimated date of First Commercial Sale in such country); provided, that:
(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).
NSP shall mean that sum determined by deducting from the gross amount billed, however characterized, for the Product, commencing on the date of First Commercial Sale and sold In Market by Acorda or an Acorda Designee, the following:
(a) transportation charges or allowances, including freight pick-up allowances, and packaging costs, if any;
7
(b) trade, quantity or cash discounts, service allowances and independent brokers or agents 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.
In the event that Acorda or its Designee shall sell the Product together with other products to third parties in a particular country and the price attributable to the Product is less than the average price of arms length sales of the Product alone in the particular country for the reporting period in which sales occur (such sales to be excluded from the calculation of the average price of arms length sales), NSP for any such sales shall be the average price of arms length sales by Acorda or its Designee of the Product alone and in the country during the reporting period in which such sales occur. If the average price of arms length sale of the Product cannot be determined in any given country, the NSP will be determined by the value of the Product sold to similar customers in countries with similar pricing and reimbursement structures and for similar quantities. Any dispute as to the determination of fair market value that cannot be resolved through discussion between the Parties shall be determined by an independent arbitrator in accordance with the provisions of Article 12.14.
Other Indication Field shall mean use as a prescription medicine for the treatment of any condition in humans, excluding the SCI Field and the MS Field, but for the avoidance of doubt including the treatment of SCI and/or MS otherwise than orally.
Other Indication Term shall mean the period beginning on the Amendment Date and ending upon expiry or termination of this Agreement, howsoever arising.
Party shall mean Acorda or Elan, as the case may be.
Parties shall mean Acorda and Elan.
Patheon Agreement shall mean the Technical Transfer Program Proposal for Commercial Registration entered into by and between Patheon, Inc. (Patheon) and Acorda dated as of February 26, 2003 relating to the manufacturing of Fampridine tablets.
Phase 3 Clinical Study shall mean a clinical trial conducted after an End of Phase 2 Meeting and conducted on a sufficient number of patients that is designed to establish that the Product is safe and efficacious for its intended Indication and is intended to
8
define warnings, precautions and adverse reactions that are associated with Product in the dosage range and formulation to be prescribed, and to support Regulatory Approval of Product for such Indication.
Product shall mean any finished pharmaceutical dosage form containing the Compound or an Alternate Compound, which is in the scope of one or more Valid Claims within the Elan Patent Rights in the country of sale, and/or incorporates Elan Know-How in material part. The use of the pre-clinical, toxicological, pharmacokinetic, metabolic, formulation, methods, clinical protocols and data developed for and on behalf of Elan (except for tests and studies conducted by or on behalf of Acorda as contemplated by this Agreement), which is included in the Elan Know-How shall constitute incorporation of the Elan Know-How in material part.
Project shall mean all activity undertaken by Elan and Acorda in order to develop the Product in accordance with the Development Plan, together with (i) all activity as undertaken by Elan and Acorda to develop the Fampridine Product for SCI prior to the Amendment Date, and (ii) all activity as undertaken by Elan, Acorda and MS R & D to develop the Fampridine Product for MS, prior to the Amendment Date.
Regulatory Approval shall mean (i) NDA approval by the FDA in the United States of America, (ii) in the case of the Major European Markets, approval of the NDA Equivalent by the EMEA in the Major European Markets (and/or the applicable regulatory authorities in such Major European Market not failing to provide or rejecting such approval), or (iii) such approvals as are required in any other country of the Territory to launch the sale of the Product in the normal course of business, as applicable, in each case including any required pricing and reimbursement approvals.
Research and Development Cost shall mean in the case of research and development being conducted by or on behalf of Elan in connection with the Project the costs thereof calculated in accordance with GAAP.
Rush shall mean Rush-Presbyterian-St. Lukes Medical Center.
Rush/Acorda License shall mean the License Agreement entered into as of the Amendment Date by and between Rush and Acorda, and any amendments or supplements thereto, the form of which, including the schedules thereto, is attached hereto as Schedule 5 .
Rush Payments Agreement shall mean the Rush Payments Agreement entered into as of the Amendment Date by and between Elan and Acorda, and any amendments or supplements thereto, in connection with the Rush/Acorda License, a form of which is attached hereto as Schedule 6 .
Rush Side Agreement shall mean the Side Agreement entered into as of the Amendment Date by and between Rush, Acorda, Elan and EDDI, and attached as a schedule to the Rush/Acorda License, and any amendments or supplements thereto.
SCI shall mean spinal cord injury indications.
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SCI Field shall mean use as an oral prescription medicine for the treatment of SCI in humans.
SCI Term shall mean the period beginning on 23 January 1997 and ending upon expiry or termination of this Agreement, howsoever arising.
SEC shall mean the United States Securities and Exchange Commission or any successor agency thereto.
Specifications shall mean the specifications for the Product(s) and API attached as Schedule 7 , as they may be modified from time to time by mutual written agreement of the Parties consistent with the specifications approved by the FDA in the NDA and, outside the United States, any NDA Equivalent.
Supply Agreement shall mean the supply agreement between Elan and Acorda of even date herewith, in the form attached hereto as Schedule 8 .
Technology Transfer Responsibilities shall mean the respective responsibilities of each of Acorda and Elan in connection with the Project relating, as applicable, to the (i) activities being conducted under the Cardinal Agreement; (ii) activities being conducted under the Patheon Agreement, and (iii) procurement of API, as set forth on Schedule 9 hereto, as such responsibilities may be modified from time to time by mutual agreement of the Parties.
Territory shall mean all of the countries of the world.
Third Party(ies) shall mean a person or entity who or which is neither a Party nor an Affiliate of a Party.
Trademark shall mean the trademark(s) as may be selected by Acorda which has been or may be registered by Acorda in one or more countries of the Territory.
Valid Claim(s) shall mean a claim in any patent within the Elan Patents which has not lapsed or become abandoned and which claim has not been declared invalid by an unreversed or an unappealable decision of a court of competent jurisdiction.
$ and US$ shall mean United States Dollars.
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;
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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 :
Elan shall remain proprietor of all the Elan Intellectual Property relating to the Product and any trademark licensed by Elan to Acorda, (such as an acronym for the applicable technology applied to the Product), but hereby grants to Acorda an exclusive (even as to Elan) licence under the Elan Intellectual Property in the Territory to package, use, import, export, promote, distribute, offer for sale, sell and otherwise exploit and, solely as permitted in the Supply Agreement, to make and have made:
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.
in each case under the terms and conditions set out herein.
2.2. Acceptance; Acorda Non-Competition :
Subject to the provisions of the following sentence, Acorda hereby accepts such licence and confirms that 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-aminopyridine active agent, other than Product ( Acorda Competing Product ) during the period Acorda retains a licence under the Agreement and for one year thereafter.
Should Acorda or its Affiliates market an Acorda Competing Product in the countries of the European Economic Area, Elan reserves as its sole remedy the right to terminate the exclusive licences granted to Acorda solely in the applicable country (ies) in which Acorda or its Affiliates market an Acorda Competing Product, which thenceforth for the remainder of the term of this Agreement shall become non-exclusive in nature in such countries of the European Economic Area, and to stop licensing improvements in such countries of the European Economic Area.
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2.3. Sub-licensing :
2.3.1 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.
2.3.2 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.
2.3.3 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.
2.4. Use of Data and Improvements :
Subject to the provisions of Article 12.1 Elan may use the Elan Intellectual Property and all technical and clinical data or improvements generated by Elan pursuant to this Agreement in connection with Elans commercial arrangements for the Product in any country which ceases to be a part of the Territory, or in relation to the Product in the Territory in the event of the termination of this Agreement.
2.5. Rush:
Each of Elan and Acorda hereby acknowledges and agrees that the licences previously granted to Elan by Rush and the licenses granted to Acorda by Rush pursuant to the Rush/Acorda License do not constitute Elan Patent Rights or Elan Know-How for the purposes of this Agreement.
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2.6. Technical Advice:
Without prejudice to Article 5.1.2, Elan shall, if requested, advise Acorda in any technical matters as may become necessary for the proper utilisation of the licence to Acorda pursuant to this Agreement and shall provide reasonable advice and assistance to Acorda with respect thereto without additional charge.
2.7. Combination Products :
In the event that Acorda wishes to develop, market and sell an oral sustained release product for the treatment of SCI which contains the Compound or an Alternate Compound as one of two or more pharmaceutically active ingredients ( Combination Product ), Acorda shall seek the consent of Elan to extend the licences granted by Elan to Acorda pursuant to this Agreement, which consent shall not be unreasonably withheld or delayed. In the event that such consent is furnished, the Parties shall negotiate in good faith the terms of an agreement, including where applicable, such amendments as are appropriate to this Agreement.
2.8. Elan Competing Product :
For the term of the Agreement, Elan shall not itself or through an Affiliate or Third Party commercialise or, develop in the Territory nor license another party in the Territory to commercialise or develop any other sustained release oral dosage form for prescription use in humans which contains the Compound or any Alternate Compound as an active ingredient for:
2.8.1 the indication of SCI; and/or
2.8.2 the indication of MS; and/or
2.8.3 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).
(each, an Elan Competing Product ).
2.9. Trademark:
2.9.1 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.
2.9.2 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:
2.9.2.1 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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or promotion or advertising which amounts to or might amount either to infringement of Elans rights in relation to the Elan Trademark or to passing off.
2.9.2.2 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.
2.9.2.3 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 Elans expense and for its own benefit.
2.9.2.4 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.
2.9.3 Acorda shall not be obliged to use the Elan Trademark to identify the Product but at Elans 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®.
2.10. 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 Acordas 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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substantively materially similar as the materials previously furnished to and approved by Elan.
2.11. Diligence :
2.11.1 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.
2.11.2 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 Acordas rights and licences shall remain in effect until and unless the arbitrator makes a decision that Acordas right and licence in such country should terminate.
2.11.3 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 Acordas 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-
15
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the
Commission.
clinical and clinical studies required for the related NDA or any NDA Equivalent, as determined by the Committee, or (y) Acorda fails to effect a commercial launch of the Product in the United States of America, Japan or the Major European Markets within the period specified in Article 2.11.2 above then, in such event, provided that Elan has terminated Acordas licence as provided in Article 12.5.2.2, Acorda shall, at the option of Elan, license, make available and transfer to Elan all of Acordas data, information, applications, approvals and filings to permit Elan to commercialise the Product in the applicable region, in exchange for an initial payment equal to Acordas costs of developing such data, information, applications, approvals and filings for such region and [*****] of NSP (for which purpose the definition of NSP as set out in Article 1 shall apply mutatis mutandis) of the Product by Elan and/or its designees (for which purpose the definition of Designee as set out in Article 1 shall apply mutatis mutandis) in such region. In such event Elan shall be entitled to a licence to the Acorda Patent Rights and the Acorda Know-How to commercialise the Product on the terms set out in this Article 2.11.3 and to the Trademark on the terms set out in Article 2.9. In the event that Elan is entitled to such licence, the Parties shall enter into a further written licence agreement which shall include customary and reasonable terms relating to, inter alia , the timing of royalty payments to Acorda, reporting obligations regarding net sales, audit rights of Acorda with respect to books and records relating to net sales, sublicense and indemnity provisions, which obligations shall, unless otherwise agreed by the Parties, be substantially similar to those in this Agreement with respect to commercialisation of the Products by Acorda.
2.11.4
2.11.4.1 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.
2.11.4.2 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 Acordas rights and licences shall remain in effect until and unless the arbitrator makes a decision that Acordas right and licence hereunder in such country should terminate.
2.11.4.3 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
16
commercialization has commenced in the Major European Markets, any other country subject to the jurisdiction of the EMEA, provided that Acorda provides to the Committee a marketing plan for such other countries} or Japan), within one hundred and (180) days after receiving the required Regulatory Approval therefor, provided that Acorda shall have ordered and 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, Elan shall be entitled to a licence to the Acorda Patent Rights and the Acorda Know-How to commercialise the Product in such countries on the terms set out in Article 2.11.3 and to the Trademark on the terms set out in Article 2.9.
ARTICLE 3 DEVELOPMENT OF THE PRODUCT
3.1. 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.
3.2. 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.
3.3. 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
17
obligations in good faith and in a commercially reasonable, diligent and workmanlike manner. Each Party will update the other Party on the progress of the Project at meetings of the Committee.
3.4. Elan will supply Acorda with Acordas 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.
3.5. 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.
3.6. 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.
3.7. 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. 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 Acordas 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 Elans 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 Elans 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 Acordas 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 Elans 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.
If Elan is required in any regulatory jurisdiction to file with any regulatory authority a DMF relating to Compound or Product, Elan shall at Acordas cost prepare and file in accordance with applicable regulatory requirements such DMF and Acorda shall have a right of reference thereto to the extent required by the NDA or any NDA Equivalent or in order to exercise its license rights under this Agreement.
Similarly, if Elan is entitled to market, distribute and sell the Product in a particular country, and Acorda is required in any regulatory jurisdiction to file with any regulatory authority a DMF relating to Compound or Product, Acorda shall at Elans cost prepare and file in accordance with applicable regulatory requirements such DMF and Elan shall have a right of reference thereto to the extent required by the NDA or any NDA Equivalent or in order to exercise its rights under this Agreement.
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portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the
Commission.
ARTICLE 5 FINANCIAL PROVISIONS
5.1. Research and Development Activities :
5.1.1 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.
5.1.2 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 [***].
5.1.3 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 Elans level of effort to assure Acorda that the committed level of effort is being applied.
5.1.4 If Elans 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.
5.2. License Royalties :
5.2.1 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
5.2.2 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)
receipt of each of which is hereby acknowledged by Elan.
5.3. Milestone Payments :
5.3.1 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:
20
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the
Commission.
5.3.1.1 [****] 90 (ninety) days after written receipt of NDA Approval of the Product for the first Indication;
5.3.1.2 [***] on the earlier of (a) 90 (ninety) days after written receipt of NDA Approval of the Product for a second Indication or (b) the 2 nd (second) anniversary of NDA Approval of the Product for the first Indication;
5.3.1.3 [***] upon the commencement of a Phase III Clinical Study of the Product for a third Indication;
5.3.1.4 [***] upon acceptance by the FDA for filing of the NDA for a third Indication;
5.3.1.5 [***] upon written receipt of NDA Approval of the Product for a third Indication;
5.3.1.6 [***] upon First Commercial Sale of the Product for a third Indication;
5.3.1.7 [***] upon the commencement of a Phase III Clinical Study of the Product for a fourth Indication;
5.3.1.8 [***] upon acceptance by the FDA for filing of the NDA for a fourth Indication;
5.3.1.9 [***] upon written receipt of NDA Approval of the Product for a fourth Indication; and
5.3.1.10 [***] upon First Commercial Sale of the Product for a fourth Indication
the payments described in Articles 5.3.1.1 to 5.3.1.10 being Milestone Payments .
5.3.2 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.
5.3.3 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.
By way of example, the Milestone Payment in Article 5.3.1.9 shall become payable upon NDA Approval for a Indication E, where Indications A, B
21
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the
Commission.
and C have already received NDA Approval, notwithstanding that commencement of a Phase III Clinical Study of the Product and/or NDA filing for Indication D may have occurred before commencement of such studies for Indication E.
5.3.4 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.
5.3.5 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.
5.4. Certain Payments relating to Rush/Acorda License :
Elan shall reimburse Acorda in respect of the milestone payments payable from Acorda to Rush pursuant to Section 5.2 of the Rush/Acorda License and Acorda shall pay Elan an additional royalty, each in accordance with and subject to the terms and conditions of the Rush Payments Agreement.
5.5. License Revenues :
In further consideration of the rights and licence granted to Acorda to the Elan Patent Rights by virtue of this Agreement, Acorda shall pay to Elan [***] of all and any License Revenues.
5.6. Royalty on Sales :
5.6.1 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:
5.6.1.1 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
22
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the
Commission.
requirements is not sold by Acorda, payment to Elan for such Product shall nonetheless be effected and the price of the Product shall be determined by reference to the NSP calculated pursuant to the provisions of Article 5.6.1.2.
5.6.1.2 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.
5.6.1.3 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.
5.6.2 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.
5.6.3 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
23
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the
Commission.
whether Acorda should have entered into such agreement) shall be resolved by referring such matter to an independent patent attorney for arbitration, and in the event of such a dispute the offset above shall only take effect prospectively upon an arbitrators decision in favour of Acorda. In such event the procedure set forth in Article 12.14 shall to the extent practicable apply to the conduct of such arbitration.
5.6.4 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.
5.6.5 All payments due hereunder shall be made in United States Dollars in accordance with Article 5.9.
5.6.6 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.
5.7. Additional Expenses :
Acorda shall pay Elan within thirty (30) days of the date of invoicing for any technical assistance requested by Acorda, including travel and subsistence, provided that Elan is not otherwise obliged to provide such assistance pursuant to the terms of the Agreement. Elans charges for such work shall be Research and Development Cost plus [***], as well as reimbursement for out-of pocket expenses incurred by Elan to Third Parties in performing activities under the Development Plan that are not already included in Research and Development Cost.
5.8. Non-Refundable Payments :
All payments received by Elan from Acorda under Article 5 shall be non-refundable, subject to the provisions of Article 5.9.5.
5.9. Payments, Reports and Records :
5.9.1 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
24
precise format of the Statement. Acorda shall also provide Elan with preliminary monthly sales reports in a format to be determined by the Committee.
5.9.2 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.
5.9.3 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.
5.9.4 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.
5.9.5 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 others independent certified accountants (reasonably acceptable to the other Party) with access, during regular business hours and upon reasonable prior request and
25
subject to the confidentiality provisions as contained in this Agreement, to such Partys books and records relating to the Product, solely for the purpose of verifying the accuracy and reasonable composition of the calculations hereunder for the calendar year then ended, including in the case of Elan the sums payable by Acorda to Elan pursuant to Article 5. If such accounting firm concludes that additional royalties were owed during such period then Acorda shall pay the additional royalties within sixty (60) days after the date of delivery of such accounting firms written report so concluding. In the event such accounting firm concludes that amounts were overpaid by Acorda during such period, Elan shall repay Acorda the amount of such overpayment within sixty (60) days after the date of delivery of such accounting firms written report so concluding.
5.9.6 In addition, for the twenty four (24) month period following the close of each calendar year, Elan will provide Acordas 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 Elans 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.
5.9.7 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.
ARTICLE 6 REGISTRATION OF THE PRODUCT
6.1. 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. Subject to the review by the Committee pursuant to Article 10 and to Elans 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.
6.3. 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 Elans reasonable expenses associated with required changes to its manufacturing license(s ).
6.4. 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.
6.5. 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 Elans 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.
6.6. During the NDA registration procedure, Acorda shall keep Elan promptly and fully advised of Acordas 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
27
shall be the primary contact with the FDA and any other regulatory authority in the Territory with respect to Product.
6.7. 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.
6.8. 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 Acordas and Elans obligations vis a vis Japan, the Major European Markets and such other countries of the Territory.
ARTICLE 8 WARRANTY AND INDEMNITY
8.1. 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 Partys challenges to Elans right to enter into this Agreement and to grant the rights and licences herein granted to Acorda and the Elan Intellectual Property.
8.2. 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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be inconsistent with the terms and conditions of any licence, contract, understanding or agreement, whether express, implied, written or oral between Elan and any Third Party.
8.3. 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 Partys challenges to Acordas right to enter into this Agreement.
8.4. 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.
8.5. 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 partys 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.
8.6. 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.
It is hereby acknowledged for the avoidance of doubt that for the purposes of this Article 8, commercial supplies of Product under the Supply Agreement are not regarded as supplied under this Agreement.
8.7. 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. 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 Acordas 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 Elans bad faith, gross negligence or intentional misconduct in connection with the preparation of the CMC Section.
8.9. 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.
8.10. 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.
8.11. 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.
8.12. 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 Elans 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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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) Elan was in breach of the foregoing representation and warranty with respect to such Third Party patent rights, Elans liability to Acorda with respect to such infringement pursuant to this Article 8.12 (including without limitation, reasonable attorneys fees and other out of pocket expenses of the litigation, including the fees and expenses incurred by Elan and Acorda) shall be limited to and shall be borne by the Parties in the manner set forth in Article 11.3.1.
For purposes of this Article 8, Elans actual knowledge shall mean the knowledge of representatives of Elan that have been engaged in the Project in a key operational role.
8.13. 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.
8.14. Acorda represents and warrants that as of the date of this Agreement to Acordas 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 Acordas belief infringe any patent owned by a Third Party.
For purposes of this Article 8, Acordas actual knowledge shall mean the knowledge of representatives of Acorda that have been engaged in the Project in a key operational role.
8.15. As a condition of obtaining an indemnity in the circumstances set out above, the Party seeking an indemnity shall:
8.15.1 fully and promptly notify the other Party of any claim or proceeding, or threatened claim or proceeding;
8.15.2 permit the indemnifying Party to take full care and control of such claim or proceeding;
8.15.3 assist in the investigation and defence of such claim or proceeding;
8.15.4 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
8.15.5 take all reasonable steps to mitigate any loss or liability in respect of any such claim or proceeding.
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8.16. 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.
8.17. EXCEPT IN RESPECT OF EACH PARTYS 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.
8.18. 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.
10.1. 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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Amendment Date of its representatives on the Committee and of the appointment of its Primary Contact and shall notify the other Party as soon as practicable upon changing its Committee representatives or the Primary Contact appointment in accordance with Article 12.12. The Primary Contact of each Party will be one of its three representatives in the Committee.
10.2. Except as specifically set forth in this Agreement, the Committee shall be responsible for overseeing the Project, including the following:
10.2.1 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;
10.2.2 facilitating the transfer of know-how, regulatory correspondence and communications and other data as contemplated by this Agreement and the Supply Agreement;
10.2.3 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;
10.2.4 discussing objectives for and performance of the Product in the Territory, and the promotional activities and materials associated therewith;
10.2.5 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
10.2.6 such other activities as are delegated to the Committee under this Agreement.
10.3. 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 Acordas 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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resolution pursuant to Article 12.14, or as otherwise agreed, except with respect to matters for which Acorda has authority to make final decisions.
10.4. 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.
10.5. At each meeting, Acorda shall summarize the status of Acordas 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.
10.6. 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.
11.1.
11.1.1 Acorda shall have the first right to file, prosecute and maintain the Elan Patent Rights in Elans 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 Acordas 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 Elans 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.
11.1.2 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 Acordas request, Elan shall reasonably cooperate in the filing, prosecution or
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk *, have been separately filed with the Commission.
maintenance of any such patent application or patent. If Acorda elects not to file, prosecute or maintain any such patent application or patent 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. Thereafter, such patent or patent application in such country shall be deemed solely an Elan Patent Right. In any such case, Acorda shall not grant any Third Party a license under its interest in the applicable Joint Invention without the prior written consent of Elan.
11.2. 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 Acordas request and expense. Elan shall receive [*] of any such recovery remaining after the deduction by Acorda of the reasonable expenses (including attorneys 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 attorneys fees and expenses) incurred in relation to such an infringement proceeding. Acorda will co-operate with such action at Elans 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.
11.3.
11.3.1 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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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk *, have been separately filed with the Commission.
limitation, reasonable attorneys fees and other out of pocket expenses of the litigation, including the fees and expenses incurred by Elan and Acorda ( Patent Expenses ):
11.3.1.1 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;
11.3.1.2 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.
During the term of this Agreement, Acorda shall have the first right but not the obligation to defend the proceedings referred to in this paragraph and Elan will co-operate with such action at Acordas request and expense. In such event Acorda shall keep Elan advised of all material developments in the said proceedings and shall not settle or compromise such proceedings without the consent of Elan which shall not be unreasonably withheld or delayed. Should Acorda decide not defend such proceedings, Elan may do so and Acorda will co-operate with such action at Elans request and expense. In such event Elan shall keep Acorda advised of all material developments in the said proceedings and shall not settle or compromise such proceedings without the consent of Acorda which shall not be unreasonably withheld or delayed.
Any sums payable by Elan to Acorda, or by Acorda to Elan pursuant to this Article 11.3.1 shall be discharged by Elan or Acorda, as the case may be, within thirty (30) days of the appropriate invoice and reasonable supporting documentation being furnished.
11.3.2 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.
11.3.3 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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patent rights of a Third Party, or entering into a licence agreement with such Third Party after due consultation with Elan.
11.3.4 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.
11.4.
11.4.1 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 attorneys 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.
11.4.2 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.
11.4.3 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 attorneys 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. 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 Acordas 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.
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
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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 partys 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
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obligations set forth herein and shall redact any confidential information set forth in such filings. In the event that either Party wishes to make an announcement concerning the Agreement, that Party shall seek the consent of the other Party, which consent shall not be unreasonably withheld or delayed and shall not be required to the extent the text of the announcement relating to this Agreement has previously been agreed to by the other Party. The terms of any such announcement shall be agreed in good faith.
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 :
This Agreement shall be binding upon and enure for the benefit of Parties hereto, their successors and permitted assigns.
40
12.4. Severability :
If any provision in this Agreement is agreed by the Parties to be, or is deemed to be, or becomes invalid, illegal, void or unenforceable under any law that is applicable hereto, (i) 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, with effect from the date of such agreement or such earlier date as the Parties may agree, and (ii) the validity, legality and enforceability of the remaining provisions of this Agreement shall not be impaired or affected in any way.
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
41
Acorda Patent Rights and the Acorda Know-How in accordance with Article 2.11.3.
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
42
Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement;
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 :
Neither Party to this Agreement shall be liable for delay in the performance of any of its obligations hereunder if such delay results from causes beyond its reasonable control, including, without limitation, acts of God, fires, strikes, acts of war, or intervention of a Government Authority, non availability of raw materials, but any such delay or failure shall be remedied by such Party as soon as practicable.
12.7. Relationship of the Parties :
Nothing contained in this Agreement is intended or is to be construed to constitute Elan and Acorda as partners or joint venturers or either Party as an employee of the other. Neither Party hereto shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement or undertaking with any Third Party.
43
12.8. Amendments :
No amendment, modification or addition hereto shall be effective or binding on either Party unless set forth in writing and executed by a duly authorised representative of both Parties.
12.9. Waiver :
No waiver of any right under this Agreement shall be deemed effective unless contained in a written document signed by the Party charged with such waiver, and no waiver of any breach or failure to perform shall be deemed to be a waiver of any future breach or failure to perform or of any other right arising under this Agreement.
12.10. No effect on other agreements :
Except as specifically set forth herein, no provision of this Agreement shall be construed so as to negate, modify or affect in any way the provisions of any other agreement between the Parties unless specifically referred to, and solely to the extent provided, in any such other agreement.
12.11. Applicable Law :
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.
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:
44
or to such other address (es) and fax numbers as may from time to time be notified by either Party to the other hereunder.
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 :
No rights or licences are granted or deemed granted hereunder or in connection herewith, other than those rights expressly granted in this Agreement.
12.14. Arbitration :
Any dispute under this Agreement which is not settled by the Committee or the CEOs pursuant to Article 10 or otherwise by mutual consent shall be finally settled by binding arbitration, conducted in accordance with the Commercial Arbitration Rules of the American Arbitration Association by three (3) arbitrators appointed in accordance with said rules. The arbitration shall be held in New York, New York and at least one of the arbitrators shall be an independent expert in pharmaceutical product development and marketing (including clinical development and regulatory affairs). The arbitrators shall determine what discovery will be permitted, consistent with the goal of limiting the cost and time which the Parties must expend for discovery; provided the arbitrators shall permit such discovery as they deem necessary to permit an equitable resolution of the dispute. Any written evidence originally in a language other than English shall be submitted in English translation accompanied by the original or a true copy thereof. The costs of the arbitration, including administrative and arbitrators fees, shall be shared equally by the Parties and each Party shall bear its own costs and attorneys and witness fees incurred in connection with the arbitration. A disputed performance or suspended performances pending the resolution of the arbitration must be completed within thirty (30) days following the final decision of the arbitrators or such other reasonable period as the arbitrators determine in a written opinion. The parties shall use all reasonable efforts to ensure that any arbitration subject to this Article 12.14 shall be completed within one (1) year from the filing of notice of a request for such arbitration. The arbitration proceedings and the decision shall not be made public without the joint consent of the Parties and each Party shall maintain the confidentiality of such proceedings and decision, subject to any contrary provision of this Agreement or unless otherwise permitted by the other Party. The Parties agree that the decision shall be the sole, exclusive and binding remedy between them regarding any and all disputes, controversies, claims and counterclaims presented to the arbitrators. Application may be made to any court having jurisdiction over the Party (or its assets) against whom the decision is rendered for a judicial recognition of the decision and an order of enforcement .
12.15. Independent Development :
Expect as expressly set forth in Article 2.2, nothing in this Agreement will impair Acordas right to independently acquire, license, develop for itself, or have others develop for it, intellectual
45
property and technology performing similar functions as the Elan Intellectual Property or to market and distribute products based on such other intellectual property and technology.
12.16. Further Assurances :
At any time or from time to time on and after the date of this Agreement, each party shall at the request of the other (i) delivery to the other such records, data or other documents consistent with the provisions of this Agreement, (ii) execute, and delivery or cause to be delivered, all such consents, documents or further instruments of transfer or licence, and (iii) take or cause to be taken all such actions, as such party may reasonably deem necessary or desirable in order for such party to obtain the full benefits of this Agreement and the transactions contemplated hereby.
12.17. Entire Agreement :
This Agreement including its Appendices, Schedules and Exhibits, together set forth the entire agreement and understanding of the Parties with respect to the subject matter hereof, and supersedes all prior discussions, agreements and writings in relating thereto, including the letter of agreement of 31 st December 1996, the SCI Agreement, the MS Agreement (as assigned and assumed) and any term sheets or memoranda of understandings relating to any of the foregoing.
12.18. Counterparts :
This Agreement may be executed in two counterparts, each of which shall be deemed an original and which together shall constitute one instrument.
***
46
IN WITNESS THEREOF the Parties hereto have executed this Agreement in duplicate.
SIGNED |
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/s/ Klaas van Blanken/Pieter Bosse |
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for and on behalf of |
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ELAN CORPORATION, PLC. |
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Name: |
Monksland Holding BV |
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Title: |
Proxyholder |
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SIGNED |
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/s/ Ron Cohen |
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for and on behalf of |
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ACORDA THERAPEUTICS, INC. |
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Name: |
Ron Cohen |
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Title: |
President & Chief Executive Officer |
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47
SCHEDULE 1 ACORDA PATENT RIGHTS
GRANTED PATENT
Country |
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Patent Number |
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Grant Date |
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Status |
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Inventors |
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US |
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5,952,357 |
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14-Sept-1999 |
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Issued |
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Blass, J. et al. |
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Title: TREATING DISEASES OF THE ANTERIOR HORN CELLS |
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US |
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5,545,648 |
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13-Aug-1996 |
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Issued |
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Hansebout, R, et al. |
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Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION |
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AU |
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676,251 |
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03-June-1997 |
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Granted |
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Hansebout, R, et al. |
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Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION |
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CZ |
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28441 |
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20-Dec-1993 |
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Granted |
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Hansebout, R, et al. |
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Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION |
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EP |
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0626848 |
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04-June-2003 |
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Granted |
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Hansebout, R, et al. |
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|
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|
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Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION |
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HU |
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219583 |
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19-Mar-2001 |
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Granted |
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Hansebout, R, et al. |
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Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION |
48
KP |
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31250 |
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25-Aug-1997 |
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Granted |
|
Hansebout, R, et al. |
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|
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|
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|
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Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION |
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KR |
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301415 |
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25-June-2001 |
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Granted |
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Hansebout, R, et al. |
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Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION |
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NO |
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308.644 |
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25-June-2001 |
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Granted |
|
Hansebout, R, et al. |
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Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION |
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NZ |
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258844 |
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22-Sept-1997 |
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Granted |
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Hansebout, R, et al. |
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Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION |
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RU |
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2160590 |
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23-May-2000 |
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Granted |
|
Hansebout, R, et al. |
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|
|
|
|
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|
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Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION |
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SK |
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280922 |
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20-Dec-1993 |
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Granted |
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Hansebout, R, et al. |
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|
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Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION |
49
PENDING PATENT APPLICATIONS
BG |
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99047 |
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20-Dec-1993 |
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Pending |
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Hansebout, R, et al. |
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|
|
|
|
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|
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Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION |
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CA |
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2,085,785 |
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20-Dec-1993 |
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Pending |
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Hansebout, R, et al. |
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|
|
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|
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Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION |
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JP |
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6-514637 |
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20-Dec-1993 |
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Pending |
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Hansebout, R, et al. |
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|
|
|
|
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|
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Title: THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION |
50
SCHEDULE 2 ASSIGNMENT AGREEMENT
The remainder of this page is intentionally blank. The pages of this Schedule are numbered out of sequence.
51
1806 |
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Formulations and their use in the treatment of neurological diseases |
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Pending
:
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Issued
:
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1832 |
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Matrix Formulation of Potassium Chemical Blockers (Fampridine II) |
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Pending:
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52
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the
Commission.
[****]
53
SCHEDULE 5 RUSH/ACORDA LICENSE
The remainder of this page is intentionally blank. The pages of this Schedule are numbered out of sequence.
54
SCHEDULE 6 RUSH PAYMENTS AGREEMENT
The remainder of this page is intentionally blank. The pages of this Schedule are numbered out of sequence.
55
Current
Analytical Methods and Specifications For Finished Product Contained in
the US Drug Master File
[****]
56
The remainder of this page is intentionally blank. The pages of this Schedule are numbered out of sequence.
57
SCHEDULE 9 TECHNOLOGY TRANSFER RESPONSIBILITES
ELAN &
ACORDA RESPONSIBILITIES IN CONNECTION WITH FAMPRIDINE DRUG
PRODUCT TECHNOLOGY TRANSFER TO PATHEON, FAMPRIDINE STABILITY
PROGRAM AT CARDINAL (FORMERLY MAGELLAN) & FOR API
MANUFACTURERS
ELAN RESPONSIBILITIES DURING TECHNOLOGY TRANSFER TO PATHEON
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 Patheons technology transfer work in connection with batch release by Patheon
58
ACORDA RESPONSIBILITIES DURING TECHNOLOGY TRANSFER TO 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 RESPONSIBILITIES FOR PATHEON AFTER SUCCESSFUL TECHNOLOGY TRANSFER
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 RESPONSIBILITIES FOR PATHEON AFTER SUCCESSFUL TECHNOLOGY TRANSFER
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
59
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 RESPONSIBILITIES FOR CARDINAL (FORMERLY MAGELLAN) STABILITY PROGRAM
Elan will review and approve Cardinal stability protocols
Elan will review data generated from Cardinals 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
60
ACORDA RESPONSIBILITIES FOR CARDINAL (FORMERLY MAGELLAN) STABILITY PROGRAM
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 RESPONSIBILITIES FOR PROCUREMENT OF FAMPRIDINE API
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 manufacturers 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
61
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 RESPONSIBILITIES FOR PROCUREMENT OF FAMPRIDINE API
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
62
Exhibit 10.15
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the
Commission
EXECUTION COPY
Date: 26, September 2003
ELAN CORPORATION, PLC.
AND
ACORDA THERAPEUTICS, INC.
SUPPLY AGREEMENT
Fampridine SR
INDEX
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THIS SUPPLY AGREEMENT is made the September 2003
BETWEEN:
(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 ).
RECITALS:
(A) Elan and Acorda have entered into a Licence Agreement concerning the Product (as each of those terms are defined below).
(B) Elan is prepared to manufacture and supply the Product to Acorda for onward commercial supply.
(C) Elan and Acorda are desirous of entering into this Agreement to give effect to the arrangements described at Recitals (A) and (B).
NOW IT IS HEREBY AGREED AS FOLLOWS:
CLAUSE 1 PRELIMINARY
1.1. Definitions :
Act shall mean the United States Federal Food Drug and Cosmetic Act of 1934, and the rules and regulations promulgated thereunder, or any successor act, as the same shall be in effect from time to time.
Affiliate shall mean any corporation or entity controlling, controlled or under common control with Elan or Acorda, as the case may be. For the purposes of this Agreement, control shall mean the direct or indirect ownership of more than 50% of the issued voting shares or other voting rights of the subject entity to elect directors, or if not meeting the preceding criteria, any entity owned or controlled by or owning or controlling at the maximum control or ownership right permitted in the country where such entity exists.
Agreement shall mean this supply agreement (which expression shall be deemed to include the Recitals and Schedules hereto).
1
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the
Commission
Batch shall mean a specific quantity of Product that is produced according to a single manufacturing order during the same cycle of manufacture, which quantity shall be agreed in the Technical Agreement.
cGMP shall mean current Good Manufacturing Practice as defined in the Act and FDA guidance documents; or as applicable current Good Manufacturing Practice under applicable regulations in the European Union.
EEA shall mean the countries comprising the European Economic Area, as the same may change from time to time .
Effective Date shall mean the date of this Agreement.
Elans Facility shall mean Monksland, Athlone, Co. Westmeath, Ireland or such other facility as Elan may use to perform its obligations hereunder and is in compliance with the NDA and other regulatory requirements.
Elan Territory shall mean any country or countries in which Elan, or any licensee of Elan other than Acorda, is permitted to commercialise the Product, by virtue of termination of the License Agreement in that country or the grant of a license by Acorda to Elan pursuant to Article 2.11.3 of the License Agreement.
EXW or Ex Works shall have the meaning as such term is defined in the ICC Incoterms, 2000, International Rules for the Interpretation of Trade Terms, ICC Publication No. 560.
Force Majeure shall mean any cause or condition beyond the reasonable control of the party obliged to perform, including acts of God, acts of government (in particular with respect to the refusal to issue necessary import or export licenses), fire, flood, earthquake, war, riots or embargoes, strikes or other labour difficulties affecting a party, or either partys inability to obtain supplies of components of the Product howsoever arising.
FTE means Elans full time equivalent charging rate for its appropriate employees or consultants from time to time (based on cost without mark-up) which as of the Amendment Date is [***] per day.
Governmental Authority shall mean the FDA and /or all other governmental and regulatory bodies, agencies, departments or entities, whether or not located in the Territory, which regulate, direct or control commercial and other related activities in or with the Territory.
Launch Stocks shall mean the quantities of stocks of the Product required by Acorda in relation to the launch of the Product following Regulatory Approval in a Major Market, as more fully described in Clause 4.7.
Launch Year shall mean the period commencing on the date of First Commercial Sale and expiring on the last day of the month that is the twelfth (12 th ) month following the
2
date in which the First Commercial Sale occurs. For example, if the First Commercial Sale occurs on March 15 of any year, the Launch Year shall commence on March 15 of such year and expire on March 31 of the following year.
Licence Agreement shall mean that certain Amended and Restated Licence Agreement between Elan and Acorda of even date herewith.
Major Market(s) shall mean the US, the UK, France, Germany, Italy and Japan.
Manufacturing Cost shall mean the costs described in Schedule 1 as they relate to the Product, PROVIDED THAT if Elan is manufacturing the Product for sale in an Elan Territory, in no event shall Manufacturing Cost exceed Elans own costs for such manufacture, as calculated based on GAAP.
Maximum Capacity shall mean Elans maximum quarterly manufacturing capacity for the Product from time to time, as agreed in, or determined pursuant to, the Technical Agreement.
Minimum Elan Requirements shall mean for any Year, at least seventy five percent (75%) of Acordas total requirements of the Product .
Minor Deficiencies shall mean shortfalls or delays that are not inconsistent with industry accepted standards, which standards applicable to the Product shall be clarified in the Technical Agreement.
Permitted Elan Assignee shall mean any entity that purchases all or substantially all of the assets of Elans Facility and has entered into a written agreement with Elan for the benefit of Acorda whereby (inter alia) it represents to Acorda that it is (i) reasonably experienced in the field of pharmaceutical manufacturing (including the existing management of Elans Facility), (ii) in possession of sufficient financial resources and liquidity to perform the obligations of Elan under this Agreement and (iii) in good standing with the FDA.
A Permitted Elan Assignee shall also include any entity that has been formed for the purpose of acquiring Elans Facility, and shall, following such acquisition, be under the management of individuals reasonably experienced in pharmaceutical manufacturing (including the said existing management), in possession of sufficient financial resources and liquidity to perform the obligations of Elan under this Agreement, and none of which are debarred individuals or entities within the meaning of 21 U.S.C. section 335(a) or (b) and have the capacity of being in good standing with the FDA.
Product shall mean the oral product developed pursuant to the Project, in final packaged and labelled form for commercial sale or for distribution as promotional samples and as defined in the approved NDA or NDA Equivalent.
Recall means a companys removal or correction of a marketed Product that the FDA or equivalent Governmental Authority considers to be in violation of law and against
3
which such agency might reasonably be expected to initiate legal action (e.g., a seizure). A Recall does not include market withdrawal for other reasons, or a stock recovery.
Serious Failure to Supply shall mean that in a period of a Year, for reasons other than Force Majeure or the default of Acorda, Elan fails on at least two occasions to supply Acordas properly forecasted and ordered requirements of the Product in accordance with the terms of this Agreement, except for Minor Deficiencies, and the cumulative shortfall for such Year attributable to such failure(s) is at least 25% of the aggregate amount properly forecasted and ordered from Elan for delivery in such Year.
Term shall mean the term of this Agreement, as set out in Clause 11.
$ and US$ shall mean United States Dollars.
Year means each consecutive four Calendar Quarters.
1.2. Further Definitions :
In addition, the following definitions have the meanings in the Clauses corresponding thereto, as set forth below:
Definition |
|
Clause |
|
|
|
Discount |
|
9.4 |
First Approval |
|
4.1.1 |
Manufacturer |
|
7.1 |
Resumption Quarter |
|
7.6.1 |
Second Source |
|
7.1 |
Second Source Quantity |
|
7.2.1 |
Supply Price |
|
9.3.1 |
Technical Agreement |
|
5.5 |
1.3. Definitions in Licence Agreement :
Except as otherwise defined in this Agreement, all capitalised terms used in this Agreement shall have the same meaning as in the Licence Agreement.
1.4. Interpretation :
In this Agreement:
1.4.1 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.
4
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the
Commission
1.4.2 any reference to a Clause or Schedule, unless otherwise specifically provided, shall be respectively to a Clause or Schedule of this Agreement.
1.4.3 the headings of this Agreement are for ease of reference only and shall not affect its construction or interpretation.
1.4.4 the expressions include, includes, including, in particular and similar expressions shall be construed without limitation.
CLAUSE 2 EXCLUSIVE SUPPLY
2.1. Subject to the terms and conditions of this Agreement, during the Term, Acorda shall purchase its Minimum Elan Requirements of the Product in the Territory from Elan, except as provided in Clause 2.3.
2.2. Subject to the terms and conditions of this Agreement, during the Term, Elan shall not supply the Product to:
2.2.1 any person other than Acorda outside the Elan Territory; or
2.2.2 any person other than Acorda in the Elan Territory who intends, to the actual knowledge of Elan, to sell the Product outside the Elan Territory
except as requested by Acorda, PROVIDED THAT to extent required by applicable law, Elan shall be permitted to:
(a) sell the Product to a person in a country which is both part of the Elan Territory and within the EEA, notwithstanding that such person may re-sell the Product in another part of the EEA which is not part of the Elan Territory; and
(b) if any country of the EEA is part of the Elan Territory, sell the Product to a person in another country of the EEA which is not part of the Elan Territory, provided further that Elan shall not actively solicit any such sales.
2.3. Elan shall not have the obligation to use commercially reasonable efforts to supply the Product where 140% of Manufacturing Cost would exceed the Supply Price, subject to Clauses 2.4 and 2.5
2.4. In the event that either party is of the opinion that the circumstances in Clause 2.3 apply or may shortly apply, it shall promptly notify the other. In such event the parties shall meet to discuss, inter alia , the manner in which Manufacturing Cost is calculated by Elan and Acordas commercialisation plans.
2.5. If after such discussions Elan is of the opinion that if it continues to supply the Product to Acorda, the circumstances in Clause 2.3 will apply, Elan shall promptly formally so notify Acorda. In such event
5
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the
Commission
2.5.1 Elan shall use commercially reasonable efforts to supply Acorda with Product the subject of binding orders issued prior to Acordas receipt of such notification, provided that such orders relate to Product scheduled for delivery in the period of three (3) months after the date of the purchase orders, and that such Product shall be invoiced at the applicable price under Clause 9.2 or 9.3; and
2.5.2 After the expiration of the period referred to in Clause 2.5.1, Acorda shall have no further obligation to purchase Product under this Agreement, provide, however, that Acorda may at its option place further purchase orders for delivery during up to a six (6) month period immediately following the period referred to in Clause 2.5.1, subject always to Clause 4 and Clause 5, provided, further, that (i) any such purchase orders are placed not later than three (3) months from the date of Elans notice under this Clause 2.5; and (ii) any such Product ordered shall be invoiced at a price equal to Manufacturing Cost plus [**].
If following the period referred to in Clause 2.5.2, Acorda wishes to continue to purchase the Product from Elan and Elan is prepared to supply the same, the Parties shall negotiate in good faith the terms of any such supply and purchase.
As from the time of Elans notice, Acorda shall be entitled to purchase the Product from the Second Source, but without prejudice to binding purchase orders already placed with Elan and subject to the foregoing paragraph.
CLAUSE 3 REGULATORY MATTERS
3.1. Elan shall be responsible, at Elans expense, for filing for and maintaining all license and permits pertinent to Elans Facility, as distinct from the Regulatory Approvals specific to the Product, without prejudice to Elans responsibilities under the Licence Agreement in respect of preparation and delivery to Acorda for incorporation into the NDA or any NDA Equivalent, of the CMC Section.
3.2. Upon Elans prior written notice, Acorda shall permit Elan or any Affiliate to have access to the NDA and any NDA Equivalent and Regulatory Approvals and to take photocopies of same, as required by Elan to fulfil reporting requirements or as otherwise may reasonably be required by Elan in connection with this Agreement.
3.3. Inspections or Inquiries by Governmental Authorities . With respect to Product supplied by it, Elan shall be responsible for all process and equipment validation and quality control tests and procedures required by any Governmental Authority and shall take all steps necessary to pass inspection by any Governmental Authorities in the Major Markets, but without prejudice to Article 6.3 of the License Agreement. Elan shall:
3.3.1 notify Acorda as soon as possible, but in any event within the time period to be set forth in the Technical Agreement, of any notification received by Elan from a Governmental Authority to conduct an inspection of its manufacturing or other
6
facilities used in the development, manufacturing, packaging, storage or handling of the Product;
3.3.2 without delay make available to Acorda a copy of any inspection report received by Elan resulting from any inspection of any of such facilities by such Governmental Authority to the extent such report relates to Product, the formulation, manufacture, testing, storage and delivery of the Product or any premises used by Elan in performing Elans obligations under this Agreement;
3.3.3 provide Acorda with a written copy of any proposed response(s) thereto at least three Business Days prior to submitting such response to any Governmental Authority as well as a copy of the response actually submitted.
Representatives of Acorda or its Designee shall have the right to be present during the inspection and/or during the close-out session with the inspectors. Any Form 483 observations or warning letter related to the Product shall be provided promptly to Acorda, which shall have the right to review and discuss the proposed written response to such 483 observations or warning letter, and a copy of the response actually submitted shall be promptly provided to Acorda. Copies of all other correspondence with any Governmental Authority relating to that any partys activities under this Agreement will be provided to the other party within forty-eight (48) hours.
3.4. Inspection by Acorda / Governmental Authority . Elan shall make (i) any licenses and permits relating to Elans Facility; and (ii) that portion of Elans facility where the Product is manufactured, packaged, tested or stored, including all record and reference samples, available for inspection:
3.4.1 by Acordas duly qualified employee or Designee or, with the consent of Elan, by Acordas agent or contractor; or
3.4.2 by the relevant Governmental Authority.
An inspection under Clause 3.4.1 shall be limited to determining whether there is compliance with cGMP and other requirements of applicable law, including production or quality issues relating to the Product. Any consent required under this Clause 3.4 shall not be unreasonably withheld or delayed.
3.5. Preservation Samples/Retained Samples . Pursuant to all applicable laws, rules and regulations and to the Specifications, Elan shall assign and apply lot numbers and shall take from each lot of (i) the API used to manufacture Product pursuant to this Agreement; (ii) inactive ingredients used in the manufacture of Product pursuant to this Agreement; and (iii) the Product shipped to Acorda or its designee pursuant to this Agreement, preservation samples/retained samples. Elan shall retain and store the particular lot of API, other ingredients or Product, as applicable, in accordance with FDA and other applicable regulations, which currently provide for a period expiring no earlier than two years after the expiration of the shelf life of the particular lot of Product shipped to Acorda or its Designee pursuant to this Agreement. Preservation samples/retained
7
samples, as referred to herein, do not include samples retained for purposes of stability testing.
3.6. Elan shall at its option be entitled to change the manufacturing process or site for manufacture of the Product, provided that (a) Elan provides Acorda with all required information in form and substance necessary to file any related amendments or supplements to the NDA or any NDA Equivalent or, if applicable, Elan files with applicable regulatory authorities any required amendments or supplements to any DMF; (b) no such change shall take effect until all requisite regulatory approvals have been obtained, and (c) Elan shall be responsible for the costs associated with such change. Acorda shall reasonably co-operate with Elan in obtaining any such changes requested.
CLAUSE 4 FORECASTS AND ORDERS
4.1. Forecasts . Acorda shall provide Elan with bona fide written forecasts of its estimated Minimum Elan Requirements of the Product as follows:
4.1.1 within eighteen (18) months prior to the anticipated date of first Regulatory Approval in any Major Market ( First Approval ), Acorda shall provide Elan with an eighteen (18) month forecast, broken down on a quarterly basis, for the period beginning with the anticipated date of First Commercial Sale in such Major Market (which date shall be specified in the forecast);
4.1.2 thereafter, every three months until First Approval, Acorda shall provide Elan with an updated forecast on a quarterly basis;
4.1.3 within thirty (30) days of First Approval, and thereafter each calendar month not later than the 23 rd of the month, a rolling 18 month forecast, broken down on a month-by-month and country-by-country basis, for the period commencing at the beginning of the following month; and
4.1.4 not later than 1 August in each year, a five (5) year forecast, broken down on an annual basis.
Except as otherwise provided herein, all forecasts made hereunder shall be made to assist Elan in planning its production and Acorda in planning marketing and sales, shall not be binding purchase orders, and shall be without prejudice to Acordas subsequent firm orders for the Product in accordance with the terms of this agreement. Each forecast provided by Acorda shall supercede any previous forecast and may be expressed in a reasonable range. After receiving Acordas forecasts, Elan shall notify Acorda within five (5) days if Elan becomes aware that it will be unable to supply Acordas forecasted requirements of Product and, in such event, the provisions of Clause 4.6 shall be applicable.
4.2. Purchase Requirements . Subject to the agreement between the Parties relating to Launch Stocks under Clause 4.7, Acorda shall be bound to order one hundred percent
8
(100%) of the forecasted quantities of the Product for each month of the first three (3) months of the most recent rolling forecast referred to in Clause 4.1.3, but otherwise forecasts shall not be binding.
4.3. Forecasts and orders shall not increase or decrease by more than 25% in the aggregate amount of Product required in a calendar quarter compared to the previous calendar quarter, except for Launch Stocks or unless otherwise agreed by Elan. However, Elan shall use reasonable efforts to fulfil Acordas requirements in excess of duly forecasted and ordered amounts.
4.4. Forecasts and orders shall not exceed the Maximum Capacity during the applicable quarterly period.
4.5. Firm Orders . Acorda or its Designee shall provide Elan with purchase orders on the standard purchase order forms of Acorda or its Designee (without prejudice to Clause 5.4) of its Elan Minimum Requirements at least ninety (90) days before it requires each delivery of Product (subject to Clause 4.7 with respect to Launch Stocks), specifying the required delivery date in each purchase order and specifying the quantity of Product requested for commercial use and the quantity of Product for promotional and sample use.
4.6. Shortages . Elan agrees that it will use commercially reasonable efforts to prevent an interruption of supply to Acorda and shall immediately notify Acorda of any problems or unusual production situations which may adversely affect production or quality of Product or its Specifications or its timely delivery to Acorda or its designee. If, at any time during the term of this Agreement, Elan becomes aware that it will not be able to satisfy Acordas forecasts or ordered requirements for Product, then Elan shall: (i) give Acorda prompt notice thereof, (ii) take all commercially reasonable steps to enable Acorda to procure adequate quantities of Product from the Second Source in accordance with the applicable provisions of Clause 7 and (iii) if such inability is partial, Elan shall fulfill firm orders with such quantities of Product as are available. and shall continue to use its commercially reasonable efforts to fulfill orders on a timely basis.
4.7. Launch Stocks . Within six months prior to an anticipated Regulatory Approval in a Major Market, the parties shall discuss and agree upon the manufacture and purchase of specific quantities of Launch Stocks for launch of the Product in the applicable Major Market.
4.7.1 Launch Stocks shall be ordered not later than 20 Business Days from receipt by Acorda of an approval letter, from the FDA or equivalent Governmental Authority in respect of the NDA or an NDA Equivalent in another Major Market.
4.7.2 Acorda may use the validation batches of the Product as Launch Stocks, subject to compliance with applicable laws, the Licence Agreement and other provisions of this Agreement, provided that in such event, any amounts previously paid by
9
Acorda to Elan for such validation batches shall be credited against the applicable price for Launch Stocks under Clause 9.1.
CLAUSE 5 SUPPLY OF THE PRODUCT
5.1. Save as otherwise provided in this Agreement, Elan shall use commercially reasonable efforts to produce and supply to Acorda its entire Elan Minimum Requirements of the Product as set forth in and in response to firm purchase orders, within ninety (90) days of the purchase order, or one hundred and fifty (150) days for Launch Stocks or samples (subject to any required extension due to the lead times of specific components of samples).
5.2. Elan shall have no obligation to supply Product:
5.2.1 For any period, in excess of Acordas properly forecast requirements for such period (but Elan will nevertheless use its commercially reasonable efforts to fulfil Acordas requirements in excess of such amounts, having regard to its manufacturing capacity);
5.2.2 for less than a minimum order of one Batch, or such other minimum quantity as may be agreed in the Technical Agreement;
5.2.3 in partial Batches;
5.2.4 where Clause 2.3 applies; or
5.2.5 pursuant to an order which does not conform in all material respects to the provisions of Clause 4 and this Clause 5; provided that if Elan does supply pursuant to such an order in its absolute discretion, that fulfilment shall not affect Elans right to refuse to fulfil any subsequent order which does not comply in all material respects with those provisions.
5.3. The Product supplied by Elan to Acorda shall:
5.3.1 be delivered in finished packaged form in the dosages and configurations as set forth in the Specifications and agreed by the parties and included in the NDA and any NDA Equivalent;
5.3.2 be shipped EXW Elans Facility;
5.3.3 be delivered with a certificate of analysis and certificate of release in respect of the Product, in a form reasonably acceptable to Acorda (and Acorda shall be entitled to rely upon such certificate of analysis without the necessity of performing additional testing), in accordance with the terms of the Technical Agreement, cGMPs and the NDA or any NDA Equivalent; and
10
5.3.4 have a shelf life to be determined in the Technical Agreement.
5.4. The terms of this Agreement are hereby incorporated by reference into each order of Product submitted by Acorda and accepted by Elan. In the event of any conflict between an order or other written instructions and this Agreement, the terms of this Agreement shall prevail.
5.5. Not less than eighteen (18) months before the anticipated First Approval, or such later date as may be determined by the Committee, the parties shall negotiate in good faith to conclude a detailed technical agreement (the Technical Agreement ) regulating the parties respective obligations from a technical and quality perspective for the supply of the Product by Elan to Acorda, subject in all cases to compliance with cGMPs, the requirements and commitments of the NDA and any NDA Equivalent and any other applicable laws or regulations governing manufacture and supply of Product. Such agreement will include commercially reasonable terms as to:
5.5.1 the precise procedures regulating the alleged failure of any shipment of the Product to conform to the Specifications as a result of an alleged latent defect and the procedures to be adopted for the return and replacement of such Product;
5.5.2 the inspection and testing for compliance with specifications of API to be conducted by Elan prior to incorporation into Product, the testing and quality analysis of Product to be conducted by Elan prior to shipment of the Product and the format of the certificate of analysis and certificate of release to be furnished by Elan to Acorda as well as any quality analysis to be conducted by Acorda or its Designee;
5.5.3 the batch manufacturing records and other documentation to be prepared and maintained by Elan and delivered with each shipment to Acorda to show compliance with cGMP as well as other applicable United States of America and foreign laws and regulations;
5.5.4 the agreed shelf life of the Product as of the date of shipment;
5.5.5 the quantity of Product constituting a Batch and minimum Batch size of each shipment of the Product;
5.5.6 the manner in which Elan may provide Acorda with assistance in relation to field alerts, recalls, complaints and adverse events;
5.5.7 the notification of change by both parties;
5.5.8 the responsibility to collate and write annual product review and annual reports;
5.5.9 technical agreements with any subcontracted parties;
5.5.10 the stability commitments in NDA or amendments thereto;
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5.5.11 active drug substance, excipient and component supplier agreements, including audits/inspections of related manufacturing facilities;
5.5.12 procedures for determining and monitoring the marginal unit variable element of Manufacturing Cost for purposes of Clause 9.5.1;
5.5.13 such other matters relating to the manufacturing and supply of Product, including any amendments to any of the terms of this Agreement, any matters that this Agreement refers to be included in the Technical Agreement or any other matters that the Parties may mutually agree to or as may be required by the NDA or any NDA Equivalent.
CLAUSE 6 DISPUTES AS TO SPECIFICATION
6.1. All claims for failure of any delivery of the Product to conform to the Specifications must be made by Acorda in writing within sixty (60) days following delivery of Product to Acorda or its Designee except in the case of latent defects. Acorda shall promptly upon Elans request provide reasonable details of the alleged non-conformance and supporting evidence, and shall upon request permit Elan to re-test the Product. If Elan does not agree with Acordas determination of non-conformance, then Elan shall provide Acorda with a written notice of such disagreement within twenty (20) days of receipt of the non-conformance notice (adjusted for any delay in providing appropriate details or permitting re-testing), responding to Acordas claim. The Parties shall use commercially reasonable efforts to resolve such disagreement within ten (10) Business Days of Acordas receipt of Elans notice of disagreement.
6.2. Claims for latent defects, not discovered during the routine testing protocol (to be agreed in the Technical Agreement) shall be made in accordance with the Technical Agreement in writing within thirty (30) days of discovery. Failure to make timely claims in the manner to be prescribed in the Technical Agreement shall constitute acceptance of the delivery.
6.3. In the event that the Product supplied by Elan is not in compliance with the Specifications, or is otherwise adulterated, misbranded or defective, Elan shall, in addition to any other applicable remedies:
6.3.1 be responsible, at the sole cost and expense of Elan, for re-analysis, sampling, processing, return, disposal or destruction, including certification of destruction, of such non-conforming Product; and
6.3.2 at its cost, replace the nonconforming Product with Product meeting the Specifications as soon as reasonably practicable.
6.4. In the event that the nonconformity was due to a fault of Acorda, then, according to Elans orders, the Product shall either be destroyed by Acorda, or returned to Elan for
12
destruction by Elan, at Acordas expense. In such an event Acorda will not be entitled to any credit as to the non-conforming Product.
6.5. In the event of an unresolved dispute as to:
6.5.1 conformity of the Product with Specifications; or
6.5.2 whether defects in the Product are attributable to the negligent acts or omissions of Elan,
the parties shall within 30 days after expiration of the ten (10) Business Day period referred to in Clause 6.1 appoint an independent laboratory to undertake the relevant testing and its findings shall be conclusive and binding upon the parties.
All costs relating to this process shall be borne solely by the party whose testing was in error.
If the parties are unable to agree as to the independent laboratory to be used, the matter shall be referred to arbitration in accordance with Article 12.14 of the License Agreement.
CLAUSE 7 SECOND SOURCE
7.1. Process Transfer to Second Source :
Acorda shall be entitled to qualify the facility of Patheon Inc. at 2100 Syntex Court, Mississauga, Ontario as a second source of the Product ( Second Source ), subject to Patheon, Inc. (the Manufacturer ) undertaking to Elan to protect the confidentiality of Elans manufacturing processes related to Product and not use them for any other purpose, in terms reasonably satisfactory to Elan provided that Elan hereby acknowledges that the Manufacturer is in the process of being qualified as a Second Source Manufacturer.
At Acordas request, Elan shall use commercially reasonable efforts to assist in qualifying the Second Source as an alternative site of manufacture of the Product. Pursuant to this obligation, Elan shall:
7.1.1 provide Acorda or the Manufacturer (at Acordas request) with any information necessary to manufacture the Product;
7.1.2 provide to Acorda or the Manufacturer (at Acordas request) the documentation constituting the required material support, more particularly practical performance advice, shop practice, specifications as to materials to be used and control methods;
7.1.3 assist Acorda and/or the Manufacturer (at Acordas request) with the working up and use of the technology and with the training of Manufacturers personnel to
13
the extent which may reasonably be necessary in relation to the manufacture of the Product by the Manufacturer. In this regard, Elan will receive the Acordas and/or Manufacturers scientific staff, as applicable, in its premises for certain periods, the term of which will be agreed by the parties; and
7.1.4 comply with the other obligations and responsibilities of Elan relating to technology transfer to Patheon, as set forth in the Technology Transfer Responsibilities Schedule.
Acorda shall comply with its obligations and responsibilities relating to technology transfer to Patheon, as set forth in the Technology Transfer Responsibilities Schedule.
7.2. Supply of Product from Second Source:
Acorda may purchase the following quantities of Product from the Second Source and, accordingly, if so purchased, Acorda shall have no obligation to purchase such quantities from Elan and Elan shall have no obligation to supply such quantities to Acorda:
7.2.1 In any Year, up to twenty five percent (25%) of Acordas total requirements of Product for such Year, subject to Clauses 7.3.2 and 9.5 (the Second Source Quantity );
7.2.2 quantities of the Product which Elan is not obligated to, and declines to, supply pursuant to Clause 2.3;
7.2.3 quantities of Product in addition to the Second Source Quantity required to make up any portion of a valid purchase order which is either (i) not delivered by Elan by its due date for delivery (regardless of the cause of late or short delivery), except for Minor Deficiencies, or (ii) by reason of Force Majeure, to the extent not capable of being delivered by its due date for delivery, for so long as the Force Majeure continues;
7.2.4 where there is a Serious Failure To Supply, its entire requirements of the Product, subject to Clause 7.6.
7.3. Notification of Supply from Second Source; Equitable Purchase of Samples :
7.3.1 If Acorda purchases Product from the Second Source, the amount of the same, together with the quantity so purchased as samples, shall be notified to Elan in the applicable Statement.
7.3.2 Acorda shall purchase from the Second Source at least the same proportion of samples of the Product to commercial supply of Product as the proportion of samples to commercial supply purchased by Acorda from Elan.
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7.4. No Supply Restrictions On Second Source :
Acorda shall not place or attempt to place any restriction on supply from the Second Source to Elan or its licensees for sale in the Elan Territory, except to the extent of the restrictions on supply by Elan under Clause 2.2. In particular, Acorda shall not place or attempt to place any restriction on supplies from the Second Source to Elan for sale in the Elan Territory or its licensees after the end of the Term.
7.5. Responsibility for Second Source :
Assuming compliance by Elan with Clause 7.1, Acorda shall be solely responsible for:
7.5.1 all process and equipment validation in the Second Source required by applicable law or regulations and shall take all steps reasonably necessary to pass inspection by the Governmental Authority;
7.5.2 Product supplied to Acorda or its Designees by the Second Source.
7.6. Resumption of Elan Supply :
7.6.1 In the event that Product is being purchased from a Second Source as a result of Serious Failure To Supply, at such time as Elan has remedied the situation that caused it and is once again able to fulfil its obligations to supply Product pursuant to the terms and conditions of this Agreement, Elan shall so notify Acorda. Commencing on the first calendar quarter beginning after the date of such notice (the Resumption Quarter ), Acorda shall resume purchasing and Elan shall resume its obligations to supply the Minimum Elan Quantities from Elan, subject to the provisions of Clause 7.6.2.
7.6.2 Acorda shall be entitled to:
7.6.2.1 honor its binding purchase commitments from the Second Source, incurred reasonably and consistently with its practice of ordering from Elan and for delivery within three (3) months of the date of such commitments, prior to the notice referred to in Clause 7.6.1; and
7.6.2.2 subsequent to the commencement of the Resumption Quarter, in addition to the Second Source Quantity, purchase from the Second Source up to twenty five percent (25%) of Minimum Elan Requirements, to the exclusion of Elan, for two consecutive calendar quarters in order to be satisfied of Elans ability to fulfil its obligations in respect of the supply of Product pursuant to the terms and conditions of this Agreement.
7.6.3 The Technical Agreement shall contain terms applicable to the resumption of supply where the cessation is by reason of Force Majeure, which shall be not less favourable to Elan than the provisions of Clauses 7.6.1 and 7.6.2 applicable to resumption following Serious Failure to Supply.
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7.7. No Termination Right :
Absent Elans failure to use commercially reasonable efforts to supply Product in accordance with the terms of this Agreement, Acorda shall have no right to terminate this Agreement by reason of failure to supply, except as otherwise expressly provided herein.
7.8. Have Made License :
The Parties acknowledge and confirm that:
(a) to the extent that Acorda is permitted hereunder to purchase the Product from Patheon; and
(b) following termination of this Agreement, and until termination of the License Agreement
Acorda is regarded for the purposes of Article 2.1 of the License Agreement as being permitted to have the Product made by Patheon at the Second Source (subject always to the terms and conditions of this Agreement) and that the license grant under such Article 2.1 to make and have made Product extends accordingly.
CLAUSE 8 ADVERSE EVENTS AND PRODUCT RECALL
8.1. Each party shall give the other prompt notice, which shall be promptly confirmed in writing, of any occurrence that involves:
8.1.1 any material complaint about the safety or effectiveness of a Product, including a claim for death or injury following administration of such Product (that is plausibly related to the administration of such Product); and
8.1.2 any other matter arising out of this Agreement that must be reported to a Governmental Authority.
In the case of Acorda reporting to Elan matters described in Clause 8.1.2, reporting quarterly, or in such other timescale as may be agreed in the Technical Agreement, shall be considered prompt.
For the avoidance of doubt, Acorda shall have overall responsibility for adverse event reporting and medical complaints.
8.2. If a party:
8.2.1 is notified by a Governmental Authority that a Recall of a Product is required, requested or otherwise advisable as being probably needed; or
8.2.2 establishes a need to Recall a Product for non-conformities with the Specifications
16
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the
Commission
it shall promptly give to the other party written notice of the same with full details.
8.3. Unless otherwise agreed, after consultation with Elan, Acorda shall take the lead role in any Recall, market withdrawal, stock recovery or any other corrective action related to Product in a commercially reasonable manner and Elan shall afford all reasonable assistance. A final report shall be completed by Acorda and delivered promptly to Elan.
8.4. If the Recall, market withdrawal, stock recovery or other corrective action relating to a Product arises from Elans negligent acts or omissions in manufacturing the Product, or failure of the Product to conform to Specifications, the costs, including the cost of replacement quantities of Products, of such Recall, market withdrawal, stock recovery or other corrective action relating to a Product shall be borne by Elan provided that Acorda could not have discovered the said act(s) or omission(s) prior to the sale of the Product by exercising reasonable diligence. In all other circumstances, such costs shall be borne by Acorda. For purposes of this Agreement, such costs shall include the expenses of notification and destruction or return of the Recalled Product and all other documented out-of-pocket costs incurred in connection with such Recall, market withdrawal, stock recovery or other corrective action relating to a Product, but shall not include lost profits or opportunity costs of either Party.
In the event that Elan should bear the costs of any recall hereunder, Elan shall be entitled but not obliged to take over and perform the recall of the Product and Acorda shall provide Elan at no cost with all such reasonable assistance as may be required by Elan.
CLAUSE 9 FINANCIAL PROVISIONS
9.1. Price of Launch Stocks :
Elan shall invoice Acorda for Launch Stocks at a price equivalent to Manufacturing Cost plus [**], subject to reconciliation pursuant to Clause 9.3.3.
9.2. Price of Samples :
The price to be charged to Acorda for Product intended for distribution as free-of-charge promotional samples in its marketing and promotion of the Product shall be equivalent to Manufacturing Cost plus [***] which price shall apply to Product supplied EXW Elans Facility to Acorda. For the avoidance of doubt, the Parties confirm that if Acorda requires the samples to be supplied in sample packaging, Manufacturing Cost shall include all costs referable to such packaging.
9.3. Price of Product (General) :
9.3.1 Except for Product referred to in Clauses 9.1 and 9.2, the price of the Product manufactured by Elan to be charged to Acorda under this Agreement shall be equivalent to [***] of the NSP as determined by the provisions of Clause 9.3.3 (the Supply Price ), less the Discount to the extent applicable, and
17
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the
Commission
subject to Clause 2.5. The foregoing price shall apply to Product supplied EXW Elans Facility packaged and labelled in final market form and consistent with the NDA.
9.3.2 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 requirements is not sold by Acorda, payment to Elan for such Product shall nonetheless be effected and the price of the Product shall be determined by reference to the NSP calculated pursuant to the provisions of Clause 9.3.3.
9.3.3 Upon supply, Elan shall render an invoice in respect of the quantities of Product delivered to Acorda for a sum calculated by reference to [***] of then-applicable Notional NSP. The Parties shall adjust their account as of the end of each calendar quarter during such calendar year by Acorda paying to Elan, or by Elan crediting Acorda (as the case may be), the difference between the sum paid pursuant to the previous sentence and the actual Supply Price calculated each calendar quarter pursuant by reference to actual NSP in such quarter, within the period specified in Clause 9.6.
9.4. Discount :
Where Acorda purchases from Elan for delivery in any Year more than [***] tablets of the Product, Acorda shall be entitled to a discount (the Discount ) in respect of the excess equal to [***] of Elans Manufacturing Cost for such excess tablets.
The Discount is without prejudice to Clause 2.3.
9.5. Compensating Payment :
9.5.1 In respect of all Product purchased from the Second Source pursuant to Clause 7.2.1 and 7.6.2.2 , Acorda shall make a compensating payment to Elan calculated per unit as X Y, where X is the unit price that would have applied if the Product were purchased from Elan, under Clause 9.2 or 9.3 as applicable; and Y is the marginal unit variable element of Elans Manufacturing Cost applicable to such Product.
9.5.2 Such compensating payment shall be made in respect of a particular quarter at the time of provision of the Statement, based on the then Notional NSP and estimated Manufacturing Cost. The Parties shall adjust their account as of the end of each calendar year by Acorda paying to Elan, or by Elan crediting Acorda (as the case may be), the difference between the sum paid pursuant to Clause 9.5.1 and the actual payment calculated on the basis of actual applicable NSP and actual Manufacturing Cost calculated at the end of the calendar year, or such other period as may be specified in the Technical Agreementwithin sixty (60) days after the end of the calendar year.
18
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted
portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the
Commission
9.6. Time For Payment :
For the first two years following First Commercial Sale of the Product in any country of the Territory, payment for the Product supplied to Acorda shall be effected in $ within sixty (60) days of the date of the relevant invoice issued on supply by Elan pursuant to Clause 9.3.3. Thereafter, payment shall be effected by Acorda in $ within thirty (30) days of the date of the relevant invoice issued on supply by Elan pursuant to Clause 9.3.3.
The adjusting payments referred to in Clause 9.3.3 shall be made on provision of the relevant Statement.
For the avoidance of doubt, in respect of Product ordered for a particular country prior to Regulatory Approval in that country, Acorda shall be responsible for the price of such Product as from its readiness for delivery, notwithstanding that applicable law or regulations may prevent such Product from being supplied before Regulatory Approval.
9.7. Process Transfer Costs :
Except as otherwise set forth in this Agreement, in respect of the establishment, qualification and operation of the Second Source, Acorda shall be solely responsible for:
9.7.1 Acordas own costs and expenses;
9.7.2 all third party costs and expenses, including out of pocket expenses incurred by Elan, for products or services previously approved by the Committee; and
9.7.3 work conducted by Elan, its Affiliates, and their employees and consultants, under the Technology Transfer Responsibilities schedule, or as may otherwise be agreed to by the Parties, at the rate of FTE plus 45%.
9.8. VAT :
All prices for the Product and other amounts in this Agreement are exclusive of any applicable value added or any other sales tax, for which Acorda will be additionally liable, if payable, subject to Clause 10.
CLAUSE 10 PAYMENTS, REPORTS AND AUDITS
Article 5.9 of the Licence Agreement is hereby incorporated by reference herein as if restated in its entirety herein.
CLAUSE 11 DURATION AND TERMINATION
11.1. This Agreement shall be deemed to have come into force on the Effective Date and will expire upon expiry or termination of the Licence Agreement, howsoever arising.
19
11.2. In addition to the rights of termination provided for elsewhere in this Agreement, either party will be entitled forthwith to terminate this Agreement by written notice to the other party if:
11.2.1 that other party commits any breach of any of the provisions of this Agreement or the Licence Agreement, and in the case of a breach capable of cure, fails to cure the same within 60 days after receipt of a written notice giving full particulars of the breach and requiring it to be remedied; provided, that if the breaching party has proposed a course of action to cure the breach and is acting in good faith to cure same but has not cured the breach by the 60th day, such period shall be extended by such period as is reasonably necessary to permit the breach to be cured, provided that such period shall not be extended by more than 90 days, unless otherwise agreed in writing by the parties;
11.2.2 that other party goes into liquidation (except for the purposes of amalgamation or reconstruction and in such manner that the company resulting therefrom effectively agrees to be bound by or assume the obligations imposed on that other party under this Agreement);
11.2.3 an encumbrancer takes possession or a receiver is appointed over any of the property or assets of that other party;
11.2.4 any proceedings are filed or commenced by that other party under bankruptcy, insolvency or debtor relief laws or anything analogous to any of the foregoing under the laws of any jurisdiction occurs in relation to that other party.
11.3. For the purposes of Clause 11.2, a breach will be considered capable of cure if the party in breach can comply with the provision in question in all respects other than as to the time of performance (provided that time of performance is not of the essence).
11.4. Elan may terminate this Agreement by giving twelve (12) months written notice to do so to Acorda.
CLAUSE 12 CONSEQUENCES OF TERMINATION
12.1. Upon exercise of those rights of termination specified in Clause 11 or elsewhere in this Agreement, this Agreement shall, subject to the provisions of the Agreement which survive the termination of the Agreement and Clause 12.2 automatically terminate forthwith and be of no further legal force or effect, provided, however, that if the Agreement is terminated by Elan under Clause 11.4 such termination shall not be effective until the expiration of such twelve (12) month period
12.2. Upon termination of this Agreement by either party, the following shall be the consequences:
20
12.2.1 any sums that were due from Acorda to Elan under the provisions of Clause 9 or otherwise prior to the exercise of the right to terminate this Agreement as set forth herein shall be paid in full forthwith provided , that Elan has delivered Product in accordance with the Specifications and cGMP; and Elan shall not be liable to repay to Acorda any amount of money paid or payable by Acorda to Elan up to the date of the termination of this Agreement;
12.2.2 all confidentiality provisions set out herein shall remain in full force and effect for a period of 7 years from the date of termination of this Agreement;
12.2.3 all representations and warranties shall insofar are appropriate remain in full force and effect;
12.2.4 the rights of inspection and audit shall continue in force for the period referred to in the relevant provisions of this Agreement; and
12.2.5 if Elan terminates the Agreement under Clause 11.4, Acorda shall be entitled to purchase all of Acordas requirements of Product from the Second Source as from termination becoming effective.
CLAUSE 13 REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION
13.1. The following clauses of the License Agreement are hereby incorporated by reference herein as if stated herein in their entirety, except that for purposes of this Agreement, all references in such clauses to the Agreement or this Agreement shall be deemed to mean this Supply Agreement: Articles 8.2, 8.3, 8.4, 8.5, and 8.7.
13.2. Elan represents and warrants that the Product supplied to Acorda by Elan under this Agreement shall be free of any lien, security, interest or other encumbrance on title, conform to the Specifications and all applicable laws and regulations and requirements of the FDA and other Governmental 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 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 in the event of a breach of the representations of Elan contained in this Clause 13.2.
13.3. 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 failure of
21
the Product provided under this Agreement to meet the Specifications, or (iv) 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.
13.4. 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 this Agreement, (ii) any breach of any representation or warranty of Acorda made in this Agreement, (iii) damages for personal injury (including death) and/or for costs of medical treatment, caused by or attributed to the Product, or (iv) the acts or omissions of any sub-licensee appointed pursuant to the Licence Agreement, except in each case to the extent due to the negligence or wilful misconduct of Elan or to the relative extent that Elan is obliged to indemnify Acorda pursuant to Clause 13.3.
13.5. The party seeking an indemnity shall:
13.5.1 fully and promptly notify the other party of any claim or proceedings, or threatened claim or proceedings;
13.5.2 permit the indemnifying party to take full control of such claim or proceedings, with counsel of the indemnifying partys choice, provided that the indemnifying party shall reasonably and regularly consult with the indemnified party in relation to the progress and status of such claim or proceedings;
13.5.3 co-operate in the investigation and defence of such claim or proceedings; and
13.5.4 take all reasonable steps to mitigate any loss or liability in respect of any such claim or proceedings.
The indemnifying party may settle a Claim on terms which provide only for monetary relief and do not include any admission of liability. Save as aforesaid, neither the indemnifying party nor the party to be indemnified shall acknowledge the validity of, compromise or otherwise settle any Claim or proceedings without the prior written consent of the other, which shall not be unreasonably withheld.
13.6. TO THE FULLEST EXTENT PERMITTED BY LAW, APART FROM THE FOREGOING REPRESENTATIONS, WARRANTIES, COVENANTS AND INDEMNITIES, AND THOSE SET FORTH IN THE LICENSE AGREEMENT 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 PRODUCTS AND/OR ANY PATENTS OR TECHNOLOGY USED OR INCLUDED IN THE PRODUCTS, INCLUDING ANY WARRANTIES AS
22
TO MERCHANTABILITY, FITNESS FOR PURPOSE, CORRESPONDENCE WITH DESCRIPTION, OR NON-INFRINGEMENT.
13.7. 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.
13.8. Elan and Acorda shall each maintain comprehensive general liability insurance, insuring against all liability, including product liability, personal injury, physical injury and property damage in respective amounts deemed reasonable in the industry for companies of their respective size and engaged in their respective activities under this Agreement for the duration of this Agreement and for a period of 5 years thereafter.
Each party shall provide the other party with a certificate from the insurance company verifying the above and shall notify the other party in writing at least 30 days prior to the expiration or termination of such coverage.
CLAUSE 14 MISCELLANEOUS PROVISIONS
14.1. Secrecy and Confidentiality . Article 12.1 of the License Agreement is hereby incorporated by reference herein as if stated herein in its entirety.
14.2. Licence to Elan :
Acorda hereby grants to Elan and Elan hereby accepts for the Term a non-exclusive royalty-free license to use such Acorda Patent Rights and Acorda Know-How as are necessary or useful for the purpose of manufacturing the Product. Such rights shall be sub-licensable by Elan to its Affiliates and sub-contractors, for the sole purpose of manufacturing the Product in accordance with this Agreement.
14.3. Assignment :
14.3.1 Subject to the provisions of this Clause 14.3, each party be entitled without the consent of the other:
14.3.1.1 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
23
14.3.1.2 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.
14.3.2 In the event that Elan agrees to sell all or substantially all of the assets of Elans Facility, Elan shall so notify Acorda. In such event, Elan may (a) terminate this Agreement by ninety (90) days written notice to Acorda; or (b) assign all (but not, subject to the following sentences, a portion) of its rights and obligations under this Agreement to a Permitted Elan Assignee, provided that such transfer or assignment has no adverse tax implications for Acorda.
14.3.3 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, provided, that in the case of an assignment by Elan, the assignee is a Permitted Elan Assignee.
14.3.4 Except as provided for in this Clause 14.3, 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.
14.3.5 Any permitted assignee of a Party under this Clause 14.3 shall assume all related obligations of its assignor under this Agreement.
14.4. Parties bound :
This Agreement shall be binding upon and enure for the benefit of parties hereto, their successors and permitted assigns.
14.5. Severability :
If any provision in this Agreement is deemed to be, or becomes invalid, illegal, void or unenforceable under applicable laws:
14.5.1 such provision will be deemed amended to conform to applicable laws so as to be valid and enforceable; or
14.5.2 if it cannot be so amended without materially altering the intention of the parties, it will be deleted the validity, legality and enforceability of the remaining provisions of this Agreement shall not be impaired or affected in any way.
24
14.6. Force Majeure :
14.6.1 Neither party to this Agreement shall be liable for delay or failure in the performance of any of its obligations hereunder if such delay or failure results from Force Majeure.
14.6.2 If Force Majeure prevents or delays the performance by a party of any obligation under this Agreement, then the party claiming Force Majeure shall promptly notify the other party thereof in writing. The parties shall thereafter as soon as practicable discuss how best to continue their operations in accordance with this Agreement and shall thereafter continue such discussions on a regular basis while Force Majeure continues.
14.6.3 Where a party claims Force Majeure, the other partys obligations under this Agreement shall be suspended for the period while Force Majeure continues, but only to the extent reasonably required by the Force Majeure.
14.6.4 The party claiming Force Majeure shall use all reasonable efforts to avoid, minimise or remove the cause of such non-performance and to mitigate its effects and shall continue performance with due dispatch whenever such causes are removed.
14.6.5 Where Force Majeure continues for a period of six (6) months the other party shall have the right to terminate this Agreement, provided that it has complied with its obligations under this Clause 14.6.
14.7. Relationship of the parties :
14.7.1 Nothing contained in this Agreement is intended or is to be construed to constitute any of the parties hereto as partners or members of a joint venture or any party as an employee of another party.
14.7.2 No party hereto shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of any other party or to bind another party to any contract, agreement or undertaking with any third party.
14.8. Amendments :
No amendment, modification or addition hereto shall be effective or binding on any party hereto unless set forth in writing and executed by a duly authorised representative of all parties hereto.
14.9. Waiver :
No waiver of any right under this Agreement shall be deemed effective unless contained in a written document signed by the party charged with such waiver, and no waiver of any breach or failure to perform shall be deemed to be a waiver of any future breach or failure to perform or of any other right arising under this Agreement.
25
14.10. Entire Agreement :
14.10.1 Each of the parties hereto hereby acknowledges that in entering into this Agreement it has not relied on any representation or warranty except as expressly set forth herein or in the License Agreement or in any other document referred to herein.
14.10.2 This Agreement and the Licence Agreement, together with the exhibits and schedules hereto and thereto, together set forth all of the agreements and understandings between the parties with respect to the subject matter hereof, and supersede and terminate all prior agreements and understandings between the parties with respect to the subject matter hereof, including the SCI Agreement and the MS Agreement.
14.10.3 Nothing in this Clause 14.10 shall exclude any liability which any party would otherwise have to the other party or any right which either of them may have to rescind this Agreement for fraud.
14.11. Governing law and jurisdiction :
14.11.1 This Agreement shall be governed by and construed in accordance with the laws of the State of New York , excluding its conflict of laws rules.
14.11.2 Article 12.14 of the License Agreement is hereby incorporated by reference herein as if stated herein in its entirety.
14.12. Notices :
14.12.1 Any notice to be given under this Agreement shall be sent in writing in English by registered or recorded delivery post, reputable overnight courier or fax to:
Elan at |
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c/o Elan Pharma Ltd. |
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Monksland |
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Athlone |
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Co. Westmeath |
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Ireland |
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Attention: |
General Manager |
Fax: |
+353 906 492427 |
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Acorda at |
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15 Skyline Drive |
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Hawthorne, New York 10532 |
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United States of America |
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Attention: |
President |
Fax: |
914.347.4560 |
26
or to such other address(es) and fax numbers as may from time to time be notified by either party to the other hereunder.
14.12.2 Any notice sent by mail shall be deemed to have been delivered within 7 working days after despatch or delivery to the relevant courier and any notice sent by fax shall be deemed to have been delivered upon confirmation of receipt. Notice of change of address shall be effective upon receipt.
14.13. Further assurances :
At the request of any of the parties, the other party or parties shall (and shall use reasonable efforts to procure that any other necessary third parties shall) execute and do all such documents, acts and things as may reasonably be required subsequent to the signing of this Agreement for assuring to or vesting in the requesting party the full benefit of the terms hereof.
14.14. 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.
14.15. Set-off :
Each of the parties will be entitled but not obliged to set-off against any amount of money payable to it by the other party hereunder, any amount of money payable by it to the other party hereunder.
IN WITNESS WHEREOF the parties have executed this Agreement on the day and date appearing at the top of page 1.
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SCHEDULE 1 MANUFACTURING COST
Manufacturing Cost shall mean fully absorbed cost of manufacture (including packaging) which shall be determined on the basis of the following elements:
(a) Direct material, labour and overhead cost; and
(b) Such indirect labour, factory, laboratory and other overhead costs properly allocable. Overhead allocations shall include, but not be limited to, expenses of plant maintenance and engineering, plant management, receiving and warehousing, disposal and treatment of waste, building occupancy, quality control, costs of services provided to manufacturing and insurance provided to manufacturing.
Such allocations shall be in a manner consistent with GAAP from time to time and in a manner consistent with expenses and overhead allocated to other products manufactured by Elan or its Affiliates.
Where some part(s) of the manufacture or packaging is/are conducted by unaffiliated third party(ies), Manufacturing Cost shall be the amount paid to such third party(ies) plus any of the aforementioned costs incurred by Elan or its Affiliates in completing the manufacture, packaging or delivery of the Product.
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SIGNED |
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Monksland Holdings BV |
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By: |
/s/ Pieter Bosse |
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By: |
/s/ Klaas van Blanken |
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for and on behalf of |
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ELAN CORPORATION, PLC. |
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Name: |
Monksland Holdings BV |
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Title: |
Proxyholder |
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SIGNED |
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By: |
/s/ Ron Cohen |
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for and on behalf of |
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ACORDA THERAPEUTICS, INC. |
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Name: |
Ron Cohen |
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Title: |
President & Chief Executive Officer |
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29
Exhibit 10.16
LICENSE AGREEMENT
by and between
RUSH-PRESBYTERIAN-ST. LUKES MEDICAL CENTER
and
ACORDA THERAPEUTICS, INC.
1
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.
Such omitted portions, which are marked with brackets [ ] and an asterisk *, have been separately filed with the Commission.
THIS LICENSE AGREEMENT effective as of September 26, 2003 (Effective Date), by and between RUSH-PRESBYTERIAN-ST. LUKES MEDICAL CENTER, an Illinois not-for-profit corporation and having its principal office at 1725 W. Harrison St. Chicago, Ill. 60612 (RUSH) and ACORDA THERAPEUTICS, INC. , a corporation organized and existing under the laws of the State of Delaware and having its principal office at 15 Skyline Drive, Hawthorne, New York 10532 (ACORDA).
W I T N E S S E T H:
WHEREAS, RUSH has conducted investigations of the compound known as 4-aminopyridine for treatment of the symptoms of multiple sclerosis and has accordingly developed know-how in relation thereto;
WHEREAS, RUSH has received a notice of designation (the Rush Orphan Designation) from the FDA stating that the Licensed Product (as defined herein) qualifies for orphan designation for the relief of symptoms of multiple sclerosis;
WHEREAS, RUSHs right and title to the Rush Orphan Designation for the Licensed Product has been assigned to ACORDA and RUSH has consented to such assignment;
WHEREAS, RUSH has the right to grant licenses in respect of the RUSH Know-How (as defined herein) and has granted no licenses thereto except (i) the option agreement, dated September 7, 1990 (the Option Agreement), between RUSH and Elan Pharmaceutical Research Corp. (EPRC), a predecessor corporation of Elan Drug Delivery Inc., a wholly-owned subsidiary of Elan Corporation plc (ELAN) and (ii) the license agreement dated November 13, 1990 (the Rush/Elan License), between RUSH and EPRC, (the Option Agreement and the Rush/Elan License being collectively referred to herein as the Rush/Elan Agreements);
WHEREAS, pursuant to the Side Agreement, as defined below, RUSH and ELAN and EPRC have, among other things terminated the Rush/Elan Agreements as of the Effective Date;
WHEREAS, ACORDA desires to obtain exclusive license rights, with a right to grant sublicenses, under and to the RUSH Know-How (as defined herein), and RUSH desires to grant such license to ACORDA, upon the terms and conditions set forth herein; and
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, the Parties hereby agree as follows:
2
ARTICLE I
DEFINITIONS
Unless specifically set forth to the contrary herein, the following terms, where used in the singular or plural, shall have the respective meanings set forth below:
1.1. Act shall mean the Federal Food Drug and Cosmetic Act of 1934, and the rules and regulations promulgated thereunder, or any successor act, as the same shall be in effect from time to time.
1.2. Affiliate shall mean (i) any corporation or business entity of which more than fifty percent (50%) of the securities or other ownership interests representing the equity, the voting stock or general partnership interest are owned, controlled or held, directly or indirectly, by a Party; (ii) any corporation or business entity which, directly or indirectly, owns, controls or holds more than fifty percent (50%) (or the maximum ownership interest permitted by law) of the securities or other ownership interests representing the equity, voting stock or general partnership interest of a Party or (iii) any corporation or business entity of which a Party has the right to acquire, directly or indirectly, at least fifty percent (50%) of the securities or other ownership interests representing the equity, voting stock or general partnership interest thereof.
1.3. Base Royalty Term shall mean, in any country in the Territory, the period beginning with the date of the First Commercial Sale in such country and continuing until the earlier of (i) expiration of the last to expire Elan Patent in such country; or (ii) ten (10) years from the date of First Commercial Sale in such country; provided however, that, in the event that ACORDA receives Regulatory Approval in the United States for Licensed Product with an Orphan Designation for the treatment of multiple sclerosis, then the Base Royalty Term in the United States shall not be less than seven years from the date of First Commercial Sale in the United States. In the event that RUSHs further development of the RUSH Know-How results in the issuance to RUSH of a patent in any country or additional Orphan Drug Designation following the effective date of this Agreement that provides for a greater period of market exclusivity of the Product in such country, the Base Royalty Term in such country will continue for that period of market exclusivity provided by such patent or Orphan Drug Designation.
1.4. Business Day(s) shall mean any day that is not a Saturday or a Sunday or a day on which the New York Stock Exchange is closed.
1.5. Calendar Quarter shall mean the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.
1.6. Calendar Year shall mean each successive period of twelve (12) months commencing on January 1 and ending on December 31.
1.7. Compound shall mean the chemical compound known as 4-aminopyridine, as diagrammed on Schedule 1.7 hereto.
1.8. CFR shall mean the United States Code of Federal Regulations.
1.9. Effective Date shall mean the date first above written.
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1.10. Elan/Acorda License shall mean the Amended and Restated License Agreement effective as the Effective Date by and between ACORDA and ELAN.
1.11. Elan Patent shall mean any patent included in the Elan Patent Rights as set forth on Schedule 1.11 hereto
1.12. End of Phase 2 Meeting shall mean the first end of Phase 2 meeting with the FDA, as defined in 21 CFR Section 312.47, intended to determine the safety of proceeding to a Phase 3 Clinical Trial, evaluate the Phase 3 plan and protocols and identify any additional information necessary to support the NDA.
1.13. FDA shall mean the United States Food and Drug Administration and any successor agency having substantially the same functions.
1.14. First Commercial Sale shall mean the first commercial sale of Product by ACORDA, its Affiliate or its sublicensees in a country, for end use or consumption, after all required Regulatory Approvals have been granted by the governing health authority of such country. Sales for test marketing, clinical trial purposes, research and development, or compassionate or similar use where Acorda does not receive revenue from the sale other than cost recovery, shall not be deemed to constitute a commercial sale.
1.15. GAAP shall mean generally accepted accounting principles in the United States, consistently applied.
1.16. Improvement shall mean any and all improvements and enhancements, patentable or otherwise, related to the Compound or Product including, without limitation, in the manufacture, formulation, ingredients, preparation, presentation, means of delivery or administration, dosage, indication, use or packaging of Compound or Product.
1.17. Licensed Product shall mean any Product that utilizes or exploits the RUSH Know-How in the treatment of multiple sclerosis.
1.18. NDA shall mean a new drug application as defined in the Act and applicable regulations promulgated thereunder that is filed with the FDA to obtain Regulatory Approval of Licensed Product in the United States.
1.19. Neurological Indications shall mean indications concerning disorders and conditions of the neuromuscular system, central, peripheral and autonomic nervous systems, the neuromuscular junction and/or muscle. Such indications shall include, but not be limited to, multiple sclerosis and spinal cord injury.
1.20. Net Sales shall mean the gross amount invoiced for commercial sales of Product in the Territory by ACORDA or its Affiliates to Third Parties commencing upon the date of First Commercial Sale in any country in the Territory, after deducting the following:
(i) trade, cash and quantity discounts;
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(ii) credits and allowances on account of returned or rejected Product, including allowance for breakage or spoilage, recalls or Product destruction (whether voluntarily made or requested or made by a Regulatory Authority)
(iii) chargebacks, rebates or similar payments granted to customers, including, but not limited to, managed health care organizations, wholesalers, distributors, buying groups, retailers, health care insurance carriers, pharmacy benefit management companies, health maintenance organizations or other institutions or health care organizations or to federal, state/provincial, local and other governments, their agencies and purchasers and reimbursers;
(iv) sales or excise taxes, VAT or other taxes, and transportation, freight, postage, shipping and insurance charges and additional special transportation, custom duties, and other governmental charges;
(v) retroactive price reductions; and
(vi) write-offs or allowances for bad debts, to the extent permitted by GAAP.
Sales or other transfers between ACORDA and its Affiliates shall be excluded from the computation of Net Sales and no payments will be payable on such sales or transfers except where such Affiliates are end users, but Net Sales shall include the subsequent sales to Third Parties by such Affiliates.
1.21. Orphan Designation shall mean the designation of a drug as a drug for a rare disease or condition pursuant to Section 526 of the Act.
1.22. Party shall mean RUSH or ACORDA.
1.23. Phase 3 Clinical Trial shall mean a clinical trial in patients with multiple sclerosis conducted after an End of Phase 2 Meeting and conducted on a sufficient number of patients that is designed to establish that Licensed Product is safe and efficacious for its intended use, and to define warnings, precautions and adverse reactions that are associated with Licensed Product in the dosage range to be prescribed, and supporting Regulatory Approval of Licensed Product in the treatment of multiple sclerosis.
1.24. Product shall mean any finished pharmaceutical formulation for prescription use for the treatment of any human Neurological Indications which contains Compound as the therapeutically active ingredient.
1.25. Proprietary Information shall mean any and all scientific, clinical, regulatory, marketing, financial and commercial information or data, whether communicated in writing, orally or by any other means, which is owned and under the protection of one
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Party and is being provided by that Party to the other Party in connection with this Agreement.
1.26. Reduced Royalty Term shall mean, in any country in the Territory, the period of time beginning with the date following the expiration of the Base Royalty Term in such country and continuing until the fifteenth anniversary of the Effective Date.
1.27. Regulatory Authority shall mean the FDA in the U.S., the EMEA or any agency in the European Union and any health regulatory authority(ies) in any country(ies) in the Territory that holds responsibility for granting Regulatory Approval for a Product in such country(ies), and any successor(s) agency thereto having substantially the same functions.
1.28. Regulatory Approval shall mean all approvals (including pricing and reimbursement approvals required for marketing authorization), product and/or establishment licenses, registrations or authorizations of all regional, federal, state or local regulatory agencies, departments, bureaus or other governmental entities, necessary for the manufacture, use, storage, import, export, transport and sale of Product in a regulatory jurisdiction.
1.29. Royalty Year shall mean, (i) for the year in which the First Commercial Sale occurs (the First Royalty Year), the period commencing with the first day of the Calendar Quarter in which the First Commercial Sale occurs and expiring on the last day of the Calendar Year in which the First Commercial Sale occurs; and (ii) for each subsequent year commencing after the end of the First Royalty Year, each successive Calendar Year.
1.30. RUSH Know-How shall mean all information and materials, including but not limited to, discoveries, information, Improvements, processes, formulas, data, inventions, know-how and trade secrets, patentable or otherwise, which as of the Effective Date or at any time during the term of this Agreement:
(a) relate to Compound or Product; and
(b) were developed by or on behalf of RUSH, are owned by RUSH or are in RUSHs possession or control.
Such know-how shall include, without limitation, all chemical, pharmaceutical, toxicological, preclinical, clinical, assay control, regulatory submissions, designations and approvals, and any other information used or useful for the development, manufacturing and/or regulatory approval of Compound or Product, including such rights which RUSH may have to information developed by Third Parties.
1.31. Side Agreement shall mean the Side Agreement by and among RUSH, ACORDA and ELAN executed as of the Effective Date, a copy of which is attached hereto as Exhibit 1.31 .
1.32. Territory shall mean all of the countries in the world.
1.33. Third Party(ies) shall mean a person or entity who or which is neither a Party nor an Affiliate of a Party.
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ARTICLE II
LICENSE; SUBLICENSES
2.1. License Grant . RUSH hereby grants to ACORDA an exclusive (even as to RUSH) license, including the right to grant sublicenses, under the RUSH Know-How, to develop, make, have made, use, import, offer for sale, market, commercialize, distribute and sell and otherwise dispose of Product in the Territory and to use and practice the RUSH Know-How. Notwithstanding the foregoing grant, Rush is expressly permitted to use its 4-AP know how for internal development and research efforts; provided, however, that (i) such use is for non-commercial academic purposes only, and (ii) that RUSH shall promptly notify ACORDA of any intellectual property, discovery or invention, once conceived and/or reduced to practice by RUSH in the course of conducting or performing such non-commercial activity, which shall be deemed RUSH Know-How for purposes of this Agreement.
2.2. Improvements by ACORDA . All rights and title to and interest in any Improvement developed or discovered by ACORDA in connection with the license granted under Section 2.1 above or ACORDAs activities hereunder shall be vested solely in ACORDA. Notwithstanding the provisions of 2.2, Acorda will continue to have royalty obligations set forth in Article V, to the extent applicable, with respect to any Product that contains an Improvement and which includes the Compound as the primary therapeutically active ingredient.
2.3. Sublicenses. ACORDA shall have the right to grant sublicenses of the licenses granted to it under Section 2.1 of this Agreement to Affiliates or any Third Party. ACORDA shall provide written notice to RUSH of any such sublicenses.
ARTICLE III
DEVELOPMENT AND COMMERCIALIZATION
3.1. Exchange of Information . Following execution of this Agreement, RUSH shall utilize good faith reasonable efforts to disclose to ACORDA in English and in writing, all Rush Know-How not previously available or made available to ACORDA, in electronic format, where available, and hard copies (or, upon ACORDAs request, originals), with the intention to make such information available to ACORDA as soon as reasonably practicable Throughout the term of this Agreement, and in addition to the other communications required under this Agreement, RUSH shall also promptly disclose to ACORDA in English and in writing on an ongoing basis all Rush Know-How, and any and all additions or revisions thereto. To the extent not previously assigned to ACORDA, RUSH hereby conveys, assigns and transfers to ACORDA, free and clear of all claims, liens and encumbrances and contractually imposed restrictions, all right, title and interest in and to the Rush Orphan Designation. RUSH shall assist and cooperate with ACORDA in the submission of any letters or other documents to the FDA required or requested in connection with the change in ownership of the Rush Orphan Designation from RUSH to ACORDA. RUSH shall notify ACORDA promptly of any request for, or
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any expression of interest in using, Compound for research or any other purpose and shall refer any such requests or expressions of interest directly to ACORDA. RUSH shall also promptly notify ACORDA of any intellectual property, discovery or invention, once conceived and/or reduced to practice by RUSH or any employee or agent of RUSH, in the course of conducting or performing any activity relating to Compound or Product.
3.2. Development and Commercialization . ACORDA shall use commercially reasonable efforts to develop and commercialize Licensed Product. As used herein, commercially reasonable efforts shall mean efforts and resources normally used by ACORDA for a product owned by it or to which it has exclusive rights, which is of similar market potential at a similar stage in its development or product life, taking into account issues of safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory and reimbursement structure involved, the profitability of the applicable products, and other relevant factors. ACORDA shall provide RUSH with an annual written report summarizing the status of ACORDAS clinical development and regulatory activities with respect to Licensed Product, with the delivery to RUSH of the summary of the annual report to an IND submitted by ACORDA to the FDA in connection with the periodic reporting requirements of the IND to be in satisfaction of the foregoing requirement. The obligations set forth in this Section 3.2 are expressly conditioned upon the absence of any serious adverse conditions or event relating to the safety or efficacy of Compound or Product including the absence of any action by any regulatory authority limiting the development or commercialization of Compound or Product.
3.3. Regulatory Matters .
(a) ACORDA shall own, control and retain primary legal responsibility for the preparation, filing and prosecution of all filings and regulatory applications required to obtain Regulatory Approvals. ACORDA shall notify RUSH upon the receipt of Regulatory Approvals and of the date of First Commercial Sale.
(b) Upon ACORDAS request, RUSH shall consult and cooperate with ACORDA in connection with obtaining Regulatory Approval of Product.
3.4. Trademark. ACORDA shall select, own and maintain trademarks for Product in the Territory.
ARTICLE IV
CONFIDENTIALITY AND PUBLICITY
4.1. Non-Disclosure and Non-Use Obligations . All Proprietary Information disclosed by one Party to the other Party hereunder shall be maintained in confidence and shall not be disclosed to any Third Party or used for any purpose except as expressly permitted herein without the prior written consent of the Party that disclosed the Proprietary Information to the other Party during the term of this Agreement. The foregoing non-disclosure and non-use obligations shall not apply to the extent that such Proprietary Information:
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(a) is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by business records;
(b) is or becomes properly in the public domain or knowledge;
(c) is subsequently disclosed to a receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality to the disclosing Party; or
(d) is developed by the receiving Party independently of Proprietary Information received from the other Party, as documented by research and development records.
4.2. Permitted Disclosure of Proprietary Information . Notwithstanding Section 4.1, a Party receiving Proprietary Information of another Party may disclose such Proprietary Information:
(a) by ACORDA to governmental or other regulatory agencies in order to obtain patents or to gain approval to conduct clinical trials or to market Product;
(b) by ACORDA or its agents, consultants, Affiliates, sublicensees and/or other Third Parties for the research and development, manufacturing and/or marketing of the Compound and/or Product (or for such parties to determine their interests in performing such activities) on the condition that such Third Parties agree to be bound by the confidentiality obligations consistent with this Agreement; or
(c) if required to be disclosed by law or court order, provided that notice is promptly delivered to the non-disclosing Party in order to provide an opportunity to challenge or limit the disclosure obligations; provided, however, without limiting any of the foregoing, it is understood that ACORDA or its Affiliates may make disclosure of this Agreement and the terms hereof in any filings required by the Securities and Exchange Commission (SEC) or any other governmental agency, may file this Agreement as an exhibit to any filing with the SEC or such agency and may distribute any such filing in the ordinary course of its business.
4.3. Publication Neither RUSH nor any Affiliate or employee of or consultant to RUSH shall make any publication relating to Compound or Product without the prior consent of ACORDA. If RUSH proposes to submit for written or oral publication any manuscript, abstract or the like relating to Compound or Product, it shall first deliver the proposed publication to ACORDA at least thirty (30) Business Days prior to planned submission. At the request of ACORDA, the submission of such publication may be delayed for up to fourteen (14) days in addition to the said thirty Business Days, including for issues of patent protection or other matters relating to the development of Compound or Product. If ACORDA requests modifications to the publication, RUSH shall edit such publication as
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.
Such omitted portions, which are marked with brackets [ ] and an asterisk *, have been separately filed with the Commission.
reasonably necessary to prevent disclosure of trade secret or proprietary business information prior to submission of the publication or presentation.
ARTICLE V
PAYMENTS; ROYALTIES AND REPORTS
5.1. Up-front License Fee . In consideration of the rights granted by RUSH hereunder, ACORDA shall pay RUSH an up-front license fee of $200,000 within five (5) Business Days after the Effective Date.
5.2. Milestone Payments . In further consideration of the rights granted by RUSH hereunder, ACORDA or its designees shall pay RUSH the following milestone payments, 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 milestone (but payable the first time such milestone is achieved) for Licensed Product:
(a) US $[* *] upon the commencement (first dosing of the first patient) of the first Phase 3 Clinical Trial;
(b) US $[* *] upon the completion of the first Phase 3 Clinical Trial;
(c) US $[* *] upon the FDAs acceptance for filing of the NDA; and
(d) US $[* *] upon receipt of first written Regulatory Approval of the NDA for marketing in the United States by the FDA.
ACORDA shall notify RUSH in writing within thirty (30) Business Days after the achievement of each milestone and such notice shall be accompanied by the appropriate milestone payment. The milestone payments described in this Section 5.2 shall be payable only upon the initial achievement of each milestone, and no amounts shall be due hereunder for any subsequent or repeated achievement of such milestones, regardless of the number of Licensed Products for which such milestone may be achieved.
5.3. Royalties and Other Payments.
5.3.1. Royalties
(a) Subject to the terms and conditions of this Agreement, and in further consideration of the rights granted by RUSH hereunder, ACORDA or its designees shall pay to RUSH royalties during the Base Royalty Term in an amount equal to (i) [* *] of Net Sales in each Royalty Year in the United States; and (ii) [* *] of Net Sales in each Royalty Year in each country in the Territory other than the United States. Royalties on Net Sales at the rates set forth in this Section 5.3.1(a) shall accrue as of the date of First Commercial Sale of Product in the applicable country and shall continue and accrue on Net Sales on a country-by-country basis until the expiration of the Base Royalty Term in such country. Thereafter, ACORDA shall be relieved of any royalty payment under this Section 5.3.1(a).
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality.
Such omitted portions, which are marked with brackets [ ] and an asterisk *, have been separately filed with the Commission.
(b) Subject to the terms and conditions of this Agreement, and in further consideration of the rights granted by RUSH hereunder, ACORDA or its designees shall pay to RUSH royalties during the Reduced Royalty Term in an amount equal to (i) [* *] of Net Sales in each Royalty Year in the United States; and (ii) [* *] of Net Sales in each Royalty Year in each country in the Territory other than the United States. Royalties on Net Sales at the rates set forth in this Section 5.3.1(b) shall accrue as of the commencement of the Reduced Royalty Term in the applicable country and shall continue and accrue on Net Sales on a country-by-country basis until the expiration of the Reduced Royalty Term in such country. Thereafter, ACORDA shall be relieved of any royalty payment under this Agreement.
(c) The payment of royalties set forth above shall be subject to the following conditions:
(A) only one payment shall be due with respect to the same unit of Product;
(B) no royalties shall accrue on the disposition of Product by ACORDA, Affiliates or sublicensees as samples (promotion or otherwise) or as donations (for example, to non-profit institutions or government agencies) or to clinical trials or for research and and/or development or for compassionate or similar use where ACORDA does not receive revenue other than cost recovery; and
(C) RUSH shall be responsible for payment of any royalties or other obligations owed by RUSH to any Third Party.
5.3.2. Affiliate and Sublicensee Sales . In the event that ACORDA transfers Compound or Product to one of its Affiliates or sublicensees, there shall be no royalty due at the time of transfer. Subsequent sales of Product by the Affiliates or sublicensees to Third Parties such as patients, hospitals, medical institutions, health plans or funds, wholesalers (which are not sublicensees), pharmacies or other retailers, shall be reported as Net Sales hereunder.
5.3.3. Third Party Licenses . If one or more licenses from a Third Party or Third Parties are obtained by ACORDA in order to develop, make, have made, use, sell or import Compound or Product in a particular country, [* *] of any royalties or other payments paid under such Third Party patent licenses by ACORDA in such country for such Calendar Quarter shall be creditable against the royalty or other payments payable to RUSH by ACORDA in such country; provided, however, that the amount credited in any Calendar Quarter shall not exceed [* *] of the royalties that would have otherwise been payable to RUSH for such Calendar Quarter.
5.3.4. Combination Product . Notwithstanding the provisions of Section 5.3.1, in the event a Product is sold as a combination product with other biologically active components, Net Sales, for purposes of royalty payments on the combination product, shall be calculated by multiplying the Net Sales of that combination product by the
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fraction A/B, where A is the gross selling price of the Product sold separately and B is the gross selling price of the combination product. If no such separate sales are made, Net Sales for royalty determination shall be calculated by multiplying Net Sales of the combination product by the fraction C/(C+D), where C (excluding the fully allocated cost of the other biologically active component in question) is the fully allocated cost of the Compound and D is the fully allocated cost of such other biologically active components.
5.4. Reports; Payment of Royalty . During the term of the Agreement for so long as royalty payments are due, ACORDA shall furnish to RUSH a written report for each Calendar Quarter showing the Net Sales of all Products subject to royalty payments during the reporting period and the calculation of the royalties payable to RUSH under this Agreement, including deductions from Net Sales. Reports shall be due on the forty-fifth (45 th ) day following the close of each Calendar Quarter. Royalties shown to have accrued by each royalty report, if any, shall be due and payable on the date such report is due. ACORDA shall keep complete and accurate records in sufficient detail to enable the royalties hereunder to be determined. ACORDA shall retain such records for twenty-four (24) months after submission of the corresponding report.
5.5. Audits . Upon the written request of RUSH and not more than once during the twelve (12) month period next following the expiration of each Royalty Year during the term of the Agreement, ACORDA shall, at RUSHs expense, permit an independent certified public accounting firm selected by RUSH and reasonably acceptable to ACORDA to have access during normal business hours, upon thirty (30) days prior notice to ACORDA, to such of the records of ACORDA as may be reasonably necessary to verify the accuracy of the royalty reports hereunder for any Royalty Year ending not more than twenty-four (24) months prior to the date of such request. The accounting firm shall provide a written report as soon as practicable, which shall disclose only whether the royalty reports are correct or incorrect and the specific details concerning any discrepancies. This Section 5.5 shall survive the expiration or termination of this Agreement for a period of two years.
5.5.1. If such accounting firm concludes that additional royalties were owed during such period, ACORDA shall pay the additional royalties within sixty (60) days of the date RUSH delivers to ACORDA such accounting firms written report so concluding; provided however, that, in the event that ACORDA shall not be in agreement with the conclusion of such report (a) ACORDA shall not be required to pay such additional royalties and (b) such matter shall be resolved pursuant to the provisions of Section 9.6 herein. In the event such accounting firm concludes that amounts were overpaid by ACORDA during such period, such over payment will be credited against future royalties; provided, however, that, in the event that RUSH shall not be in agreement with the conclusion of such report (x) such matter shall be resolved pursuant to the provisions of Section 9.6 herein and (y) in the event that the overpayment to RUSH exceeds royalties due and owing to Rush over the term of the agreement, RUSH shall reimburse ACORDA within 60 days for any remaining overpayment. The fees charged by such accounting firm shall be paid by RUSH; provided, however, that if an error in favor of RUSH of more than five percent (5%) of the royalties due hereunder for the period being reviewed is discovered, then
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ACORDA shall pay the reasonable fees and expenses charged by such accounting firm.
5.5.2. Upon the expiration of twenty-four (24) months following the end of any Royalty Year (subject to tolling of such period during the pendency of an audit relating to such period under Section 5.5.1 above) the calculation of royalties payable with respect to such year shall be binding and conclusive upon RUSH, and ACORDA shall be released from any liability or accountability with respect to royalties for such year.
5.5.3. RUSH shall treat all financial information subject to review under this Section 5.5 in accordance with the confidentiality provisions of this Agreement.
5.6. Payment Exchange Rate . All payments to RUSH under this Agreement shall be made in United States dollars. In the case of sales outside the United States, the rate of exchange to be used in computing Net Sales shall be calculated monthly in accordance with the conversion rates published in the Wall Street Journal, Eastern edition (if available).
5.7. Tax Withholding . If laws, rules or regulations require withholding of income taxes or other taxes imposed upon payments set forth in this Article V, RUSH shall provide ACORDA, prior to any such payment, annually 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) and ACORDA shall make such withholding payments as required and subtract such withholding payments from the payments set forth in this Article V. ACORDA will use commercially reasonable efforts consistent with its usual business practices and cooperate with RUSH to ensure that any withholding taxes imposed are reduced as far as possible under the provisions of the current or any future taxation treaties or agreements between foreign countries.
5.8. Exchange Controls . Notwithstanding any other provision of this Agreement, if at any time legal restrictions prevent the prompt remittance of part or all of the royalties with respect to Net Sales in any country, payment shall be made through such lawful means or methods as ACORDA may determine. When in any country the law or regulations prohibit both the transmittal and deposit of royalties on sales in such a country, royalty payments shall be suspended for as long as such prohibition is in effect (and such suspended payments shall not accrue interest), 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 (with any interest earned on such suspended royalties which were placed in an interest-bearing bank account in that country, 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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ARTICLE VI
REPRESENTATIONS AND WARRANTIES
6.1. RUSH Representations and Warranties . RUSH represents and warrants to ACORDA that as of the Effective Date:
(a) Each of this Agreement and the Side Agreement has been duly executed and delivered by RUSH and constitutes legal, valid, and binding obligations enforceable against RUSH in accordance with their respective terms;
(b) no approval, authorization, consent, or other order or action of or filing with any court, administrative agency or other governmental authority is required for the execution and delivery by RUSH of this Agreement or the Side Agreement or the consummation by RUSH of the transactions contemplated hereby or thereby except such consents or filings as are contemplated by this Agreement;
(c) RUSH has the full corporate power and authority to enter into and deliver this Agreement and the Side Agreement, to perform and to grant the licenses granted under Article II hereof and to consummate the transactions contemplated hereby and by the Side Agreement; all corporate acts and other proceedings required to be taken to authorize such execution, delivery, and consummation have been duly and properly taken and obtained;
(d) With the exception of the Rush/Elan Agreements, which have terminated in their entirety pursuant to the Side Agreement, RUSH has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the Compound or Product or the RUSH Know-How or entered into any agreement with any Third Party which is in conflict with the rights granted to ACORDA pursuant to this Agreement;
(e) RUSH is the sole and exclusive owner of the RUSH Know-How, all of which are free and clear of any security interests, liens, charges, encumbrances or restrictions on license, and no Third Party has any claim of ownership or other rights with respect to the RUSH Know-How, whatsoever, except that RUSH agrees and acknowledges that the Orphan Designation has been assigned to ACORDA;
(f) RUSH has the sole and exclusive authority to grant the rights and licenses granted under Article II and, with the exception of the Rush/Elan Agreements, which have terminated in their entirety pursuant to the Side Agreement, RUSH has not previously granted, and will not grant, or engage in any discussions to grant, during the term of this Agreement, any right, license or interest in and to the Compound or Product or the RUSH
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Know-How, or any portion thereof, inconsistent with the license granted to ACORDA herein;
(g) there are no claims, judgments or settlements against or owed by RUSH or pending or, to the best of its knowledge, threatened claims or litigation relating to the Compound or the Rush Know-How;
(h) RUSH will use reasonable efforts to disclose to ACORDA all relevant information known by it regarding the Rush Know-How reasonably related to the activities contemplated under this Agreement to the extent such Rush know-how has not previously been disclosed;
(i) in connection with development of the Rush Know-How, RUSH has complied in all material respects with applicable U.S. laws and regulations;
(j) RUSH has not filed and is not the owner in any country in the Territory of any patents or patent applications or of any certificates of invention or applications for certificates of invention, relating to Compound or Product; and
(k) With the exception of the Rush/Elan Agreements, which have terminated in their entirety pursuant to the Side Agreement, there are no contracts, agreements or any other arrangements between RUSH and any Third Party relating to the research, development or commercialization of the Compound or Product.
6.2. ACORDA Representations and Warranties . ACORDA represents and warrants to RUSH that as of the Effective Date:
(a) Each of this Agreement and the Side Agreement have been duly executed and delivered by it and constitutes legal, valid, and binding obligations enforceable against ACORDA in accordance with their respective terms;
(b) it has full corporate power and authority to execute and deliver this Agreement and the Side Agreement and to consummate the transactions contemplated hereby and thereby. All corporate acts and other proceedings required to be taken to authorize such execution, delivery, and consummation have been duly and properly taken and obtained;
(c) no approval, authorization, consent, or other order or action of or filing with any court, administrative agency or other governmental authority is required for the execution and delivery by it of this Agreement or the Side Agreement or the consummation by it of the transactions contemplated hereby or thereby.
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ARTICLE VII
7.1. Indemnification . ACORDA shall defend, indemnify and hold harmless RUSH from and against any and all loss, cost and liability, including RUSHs reasonable attorneys fees and costs (Losses), arising in connection with claims made by Third Parties respecting the manufacture, sale or use of any Product by such Third Party (Claims). RUSH shall give ACORDA prompt notice of any such Loss or claim, shall cooperate in its defense, and shall give ACORDA full authority to defend and settle such claim on RUSHs behalf.
7.2. The indemnity obligation set forth in Section 7.1 above shall not apply in the case of Losses or Claims caused by or based on (i) RUSHs gross negligence or willful misconduct; (ii) any breach of this Agreement by RUSH; or (iii) any violation of RUSHs representations or warranties hereunder.
ARTICLE VIII
TERM AND TERMINATION
8.1. Term and Expiration . This Agreement shall be effective as of the Effective Date and unless terminated earlier pursuant to Section 8.2 below, the term of this Agreement shall continue in effect until expiration of all royalty or other payment obligations hereunder.
8.2. Termination .
8.2.1 Termination for Cause . Either Party may terminate this Agreement by notice to the other Party at any time during the term of this Agreement as follows:
(a) if the other Party is in breach of any material obligation hereunder by causes and reasons within its control, or has breached, in any material respect, any representations or warranties set forth in Article VI, and has not cured such breach within ninety (90) days after notice requesting cure of the breach, provided, however, that if the breach is not capable of being cured within ninety (90) days of such written notice, the Agreement may not be terminated so long as the breaching Party commences and is taking commercially reasonable actions to cure such breach as promptly as practicable; or
(b) upon the filing or institution of bankruptcy, reorganization, liquidation or receivership proceedings, or upon an assignment of a substantial portion of the assets for the benefit of creditors by the other Party; provided, however , in the case of any involuntary bankruptcy, reorganization, liquidation, receivership or assignment proceeding such right to terminate shall only become effective if the Party consents to the involuntary proceeding or such proceeding is not dismissed within ninety (90) days after the filing thereof.
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8.2.2 Licensee Rights Not Affected.
8.3. Effect of Expiration or Termination . Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination. ACORDA and its Affiliates and sublicensees shall have the right to sell or otherwise dispose of the stock of any Product subject to this Agreement then on hand or in process of manufacture and ACORDA will continue to pay Rush royalties pursuant to Article V after the expiration or termination of this Agreement for any such Product sold. In addition to any other provisions of this Agreement which by their terms continue after the expiration of this Agreement, the provision of Article IV shall survive the expiration or termination of this Agreement and shall continue in effect for five (5) years from the date of expiration or termination and the provisions of Article IX shall survive the expiration or termination of this Agreement. Upon any termination of this Agreement, each party shall promptly return to the other party all Proprietary Information received from the other party (except one copy of which may be retained for archival purposes). In addition, any other provision required to interpret and enforce the Parties rights and obligations under this Agreement shall also survive, but only to the extent required for the full observation and performance of this Agreement. Any expiration or early termination of this Agreement shall be without prejudice to the rights of any Party against the other
17
accrued or accruing under this Agreement prior to termination. In the event ACORDA breaches any of the financial provisions contained in this Agreement, in lieu of any other remedy that may be available, RUSH shall be entitled to pursue its remedies at law, but shall not be entitled to injunctive relief.
ARTICLE IX
MISCELLANEOUS
9.1. Right to Develop Independently . Nothing in this Agreement will impair ACORDAs right to independently acquire, license, develop, or have others develop for it, products similar to or performing functions similar to Product, or similar technology performing similar functions to the Products or to market and distribute products based on other technology.
9.2. Force Majeure . Neither Party shall be held liable or responsible to the other Party nor be deemed to have defaulted under or breached the Agreement for failure or delay in fulfilling or performing any term of the Agreement during the period of time when such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party including, but not limited to, fire, flood, embargo, war, acts of war (whether war be declared or not), insurrection, riot, civil commotion, strike, lockout or other labor disturbance, act of God or act, omission or delay in acting by any governmental authority or the other Party. The affected Party shall notify the other Party of such force majeure circumstances as soon as reasonably practicable.
9.3. Assignment . The Agreement may not be assigned or otherwise transferred without the prior written consent of the other Party; provided, however, that ACORDA may assign this Agreement to an Affiliate or in connection with the transfer or sale of its business or all or substantially all of its assets related to Compound or Product or in the event of a merger, consolidation, change in control or similar corporate transaction. Any permitted assignee shall assume all obligations of its assignor under this Agreement.
9.4. Severability . In the event that any of the provisions contained in this Agreement are held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affect the substantive rights of the Parties. In such event, the Parties shall replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.
9.5. Notices . All notices or other communications which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:
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if to ACORDA to:
ACORDA THERAPEUTICS, INC.
15 Skyline Drive
Hawthorne, New York 10532
Attention: : President
Fax No.: 914.347.4560
if to RUSH to:
RUSH-PRESBYTERIAN-ST. LUKES MEDICAL CENTER
1725 W.
Harrison Street
Chicago, Illinois 60612
Attention: Intellectual Property Office/General Counsels Office
Fax No.: 312-942-2055
or to such other address as the Party to whom notice is to be given may have furnished to the other Parties in writing in accordance herewith. Any such communication shall be deemed to have been given when delivered if personally delivered or sent by facsimile on a Business Day, upon confirmed delivery by nationally-recognized overnight courier if so delivered and on the third Business Day following the date of mailing if sent by registered or certified mail.
9.6. Applicable Law and Dispute Resolution . The Agreement shall be governed by and construed in accordance with the laws of the United States of America and State of New York without reference to any rules of conflict of laws.
(a) The Parties agree to attempt initially to solve all claims, disputes, or controversies arising under, out of, or in connection with this Agreement (a Dispute) by conducting good faith negotiations. Any Disputes which cannot be resolved by good faith negotiation within twenty (20) Business Days, shall be referred, by written notice from either Party to the other, to the Chief Executive Officer of each Party. Such Chief Executive Officers shall negotiate in good faith to achieve a resolution of the Dispute referred to them within twenty (20) Business Days after such notice is received by the Party to whom the notice was sent. If the Chief Executive Officers are unable to settle the Dispute between themselves within twenty (20) Business Days, they shall so report to the Parties in writing. The Dispute shall then be referred to mediation as set forth in the following subsection (b).
(b) Upon the Parties receiving the Chief Executive Officers report that the Dispute referred to them pursuant to subsection (a) has not been resolved, the Dispute shall be referred to mediation by written notice from either Party to the other. The mediation shall be conducted pursuant to the American Arbitration Association (AAA) procedures. The place of the mediation shall be Chicago, Illinois. If the Parties have not reached a settlement within twenty (20) Business Days of the date of the notice of mediation, the Dispute shall be referred to arbitration pursuant to subsection (c) below.
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(c) If after the procedures set forth in subsections (a) and (b) above, the Dispute has not been resolved, a Party shall decide to institute arbitration proceedings, it shall give written notice to that effect to the other Party. The Parties shall refrain from instituting the arbitration proceedings for a period of sixty (60) days following such notice. During such period, the Parties shall continue to make good faith efforts to amicably resolve the dispute without arbitration. If the Parties have not reached a settlement during that period the arbitration proceedings shall go forward and be governed by the AAA rules then in force. Each such arbitration shall be conducted by a panel of three arbitrators: one arbitrator shall be appointed by each of RUSH and ACORDA and the third arbitrator, who shall be the Chairman of the tribunal, shall be appointed by the two-Party appointed arbitrators. Any such arbitration shall be held in Chicago, Illinois, USA.
The arbitrators shall have the authority to direct the Parties as to the manner in which the Parties shall resolve the disputed issues, to render a final decision with respect to such disputed issues, or to grant specific performance with respect to any such disputed issue. Judgment upon the award so rendered may be entered in any court having jurisdiction or application may be made to such court for judicial acceptance of any award and an order of enforcement, as the case may be. Nothing in this Section shall be construed to preclude either Party from seeking provisional remedies, including but not limited to, temporary restraining orders and preliminary injunctions, from any court of competent jurisdiction, in order to protect its rights pending arbitration, but such preliminary relief shall not be sought as a means of avoiding arbitration. In no event shall a demand for arbitration be made after the date when institution of a legal or equitable proceeding based on such claim, dispute or other matter in question would be barred by the applicable statute of limitations. Each Party shall bear its own costs and expenses incurred in connection with any arbitration proceeding and the Parties shall equally share the cost of the mediation and arbitration levied by the AAA.
Any mediation or arbitration proceeding entered into pursuant to this Section 9.6 shall be conducted in the English language. Subject to the foregoing, for purposes of this Agreement, each Party consents, for itself and its Affiliates, to the jurisdiction of the courts of the State of New York, county of New York and the U.S. District Court for the Southern District of New York.
9.7. Entire Agreement . This Agreement, together with the exhibits and schedules hereto, contains the entire understanding of the Parties with respect to the subject matter hereof and supersedes all previous writings and understandings between the Parties. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by all Parties hereto.
9.8. Independent Contractors . It is expressly agreed that the Parties shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture or agency. Neither Party shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior consent of such other Party.
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9.9 Waiver . The waiver by a Party hereto of any right hereunder or the failure to perform or of a breach by another Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other Party whether of a similar nature or otherwise.
9.10. Further Assurances . At any time or from time to time on and after the Effective Date, RUSH shall at the request of ACORDA (i) deliver to ACORDA such records, data or other documents consistent with the provisions of this Agreement, (ii) execute, and deliver or cause to be delivered, all such consents, documents or further instruments of transfer or license, and (iii) take or cause to be taken all such actions as ACORDA may reasonably deem necessary or desirable in order for ACORDA to obtain the full benefits of this Agreement and the transactions contemplated hereby.
9.11. Headings . The captions to the several Articles and Sections hereof are not a part of the Agreement, but are merely guides or labels to assist in locating and reading the several Articles and Sections hereof.
9.12. Counterparts . The Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
9.13. Use of Names . Except as otherwise provided in this Agreement, neither Party shall not use the name of the other Party in relation to this transaction in any public announcement, press release or other public document without the consent of the other Party (which consent shall not be unreasonably withheld or delayed), except as may be required by applicable law.
9.14. LIMITATION OF LIABILITY . NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY INDIRECT CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT, HOWEVER CAUSED, UNDER ANY THEORY OF LIABILITY.
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first set forth above.
RUSH-PRESBYTERIAN-ST. LUKES MEDICAL CENTER
By: |
/s/ James T. Frankenbach |
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Name: James T. Frankenbach |
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Title: Senior Vice President |
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ACORDA THERAPEUTICS, INC. |
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By: |
/s/ Ron Cohen |
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Name: Ron Cohen |
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Title: President and Chief Executive Officer |
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SCHEDULE 1.7
DIAGRAM OF COMPOUND
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SCHEDULE 1.11
ELAN PATENT RIGHTS
For purposes of this Agreement, Elan Patent Rights shall mean any and all rights under any and all patents and patent applications now existing, currently pending or hereafter filed, owned or acquired or licensed by Elan (and/or its Affiliates) which would be infringed by the manufacture, use or sale of the Product, the current status of which is set forth below. Elan Patent Rights shall also include all continuations, continuations-in-part, divisionals and re-issues of such patents and patent applications and any patents issuing thereon and extensions of any patents licensed hereunder. Elan Patent Rights shall further include any patents or patent applications covering any improved methods of making or using the Product invented or acquired by Elan (and/or its Affiliates) during the term of the Elan/Acorda Agreement and under which Elan (and/or its Affiliates) has a right to grant a licence under the Elan/Acorda Agreement, and Elans (and/or its Affiliates) interest in any intellectual property conceived reduced to practice or otherwise developed in connection with the Project (as defined in the Elan/Acorda Agreement).
1806 |
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Formulations and their use in the treatment of neurological diseases |
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Pending
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2054822
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Issued : |
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Australia
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657706
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EXHIBIT 1.31
SIDE AGREEMENT
(Filed as Exhibit 10.17 with this registration statement on Form S-1)
25
Exhibit 10.18
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
RUSH PAYMENTS AGREEMENT
REFERENCE IS MADE to (i) the License Agreement effective as of September 26, 2003, by and between RUSH-PRESBYTERIAN-ST. LUKES MEDICAL CENTER , an Illinois not-for-profit corporation and having its principal office at 1725 W. Harrison St. Chicago, Ill. 60612 (Rush), and ACORDA THERAPEUTICS, INC. , a corporation organized and existing under the laws of the State of Delaware and having its principal office at 15 Skyline Drive, Hawthorne, New York 10532 (Acorda), including the Side Agreement attached thereto as Exhibit 1.31 by and among Rush, Acorda and Elan (as defined below) (the Side Agreement ), a copy of which is attached as Exhibit A hereto (the Rush/Acorda License ); and (ii) the Amended and Restated License Agreement effective as of September 26, 2003 by and between Acorda and 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) (the Elan/Acorda License ). The Rush/Acorda License and the Elan/Acorda License are sometimes collectively referred to herein as the Novation Agreements and Elan and Acorda are sometimes referred to herein as the Parties.
WHEREAS, in connection with and in consideration of the Novation Agreements, Acorda and Elan have agreed to enter into this Rush Payments Agreement with the intention to set forth the respective allocation between the Parties of certain amounts payable under the Rush/Acorda License and certain other rights and obligations of the Parties.
NOW THEREFORE, in consideration of the premises and the mutual covenants hereinafter recited and set forth in the Novation Agreements and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, the Parties agree as follows:
1. With respect to the US $[**] license fee set forth in Section 5.1 of the Rush/Acorda License, each of Acorda and Elan shall be responsible for [**] of such license fee. Accordingly, on the Effective Date, Elan shall pay Acorda US$[**] as Elans [**] share of such payment.
2. With respect to milestone payments that become payable under Section 5.2 of the Rush/Acorda License, the following shall be applicable:
(a) Each of Acorda and Elan shall be responsible for [**] of any milestone payments payable to Rush under Section 5.2 (a) or 5.2 (b) of the Rush/Acorda License. Accordingly, if the milestone events set forth in either Section 5.2 (a) or Section 5.2 (b) of the Rush/Acorda License are achieved, (x) Acorda shall so advise Elan in writing upon achievement of the applicable milestone event, and (y) Elan shall pay Acorda an amount equal to [**] of the applicable milestone payment upon receipt of such notice as Elans share of such payment; and
(b) Elan shall be responsible for [**] of any milestone payments payable to Rush under Section 5.2 (c) of the Rush/Acorda License. Accordingly, if the milestone event set forth in Section 5.2 (c) of the Rush/Acorda License is achieved, Acorda shall so advise Elan in writing upon achievement of the applicable milestone event and Elan shall pay Acorda an amount equal to [**] of the applicable milestone payment upon receipt of such notice.
1
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
3. In addition, Acorda shall pay to Elan an additional royalty of:
(i) [**] of NSP of the Product sold outside the US during the Base Royalty Term (as such term is defined in the Rush/Acorda License);
(ii) [**] of NSP of the Product sold outside the US during the Reduced Royalty Term (as such term is defined in the Rush/Acorda License);
(iii) during the Reduced Royalty Term, [**] of the difference between (a) the royalty that would have been payable by Acorda to Rush during the Base Royalty Term and (b) the royalty payable by Acorda to Rush during the Reduced Royalty Term under Section 5.3.1 of the Rush/Acorda License on such sales of Product in the applicable country; and/or
(iv) after termination or expiration of Acordas royalty obligations to Rush under the Rush/Acorda License in any country, [**] of NSP of the Product in such country; (with the amounts payable under the foregoing subparagraphs (i), (ii) (iii) and/or (iv), as applicable, referred to as the Additional Royalty);
provided, however, that in the event the provisions of Clause 5.6.2 or Clause 5.6.3 of the Elan/Acorda License are applicable, any Additional Royalty payable shall be limited to [**] of NSP of Product. All payments of the Additional Royalty shall be made in accordance with the provisions of Clauses 5.6.4, 5.6.5 and 5.6.6 of the Elan/Acorda License, and Article 5.9 of the Elan/Acorda License, to the extent applicable.
4. In the event that Elan breaches any of its financial obligations and undertakings under Paragraph 2 of this Rush Payments Agreement, Acorda may offset and credit the amount of the unpaid financial obligation, together with accrued interest thereon, against any amounts payable from Acorda to Elan under the Elan/Acorda License including, without limitation, amounts payable under Section 3.4 of the Elan/Acorda License. In the event that it is determined that Acorda has incorrectly offset or credited any amounts pursuant to this Paragraph 4, Acorda shall promptly pay the incorrectly offset or credited amount, together with accrued interest thereon, to Elan.
5. In the event that Acorda has breached any financial or other curable obligation under the Rush/Acorda License which breach would give Rush the right, pursuant to the Section 8.2.1 of the Rush/Acorda License, to terminate the Rush/Acorda License and, pursuant to the terms of the Side Agreement, Elan has the right to and remedies such breach (provided, however, that Elan shall not have the right to remedy such breach if such breach has been consented to by Elan or is primarily due to the fault of Elan or if Elan is in breach of the terms of this Rush Payments Agreement or the Elan/Acorda License), Elan may charge Acorda an amount equal to the amount so paid by Elan to Rush to remedy such breach on behalf of Acorda. In the event that it is determined that Elan has incorrectly charged any amounts to Acorda pursuant to this
2
Paragraph 5 and Acorda has paid such amounts, Elan shall promptly repay to Acorda the incorrectly charged and paid amount, together with accrued interest thereon.
6. In the event that Rush terminates the Rush/Acorda License pursuant to Section 8.2.1 thereof as a result of a breach by Acorda and, pursuant to the terms of the Side Agreement, Elan has the right to and elects to assume the rights and obligations of Acorda under the Rush/Acorda License (provided, however, that Elan shall not have the right to assume such rights and obligations if such breach has been consented to by Elan, is primarily due to the fault of Elan or if Elan is in breach of the terms of this Rush Payments Agreement or the Elan/Acorda License), Elan may charge Acorda an amount equal to any amounts or financial obligations so paid or incurred by Elan to Rush pursuant to Elans assumption of Acordas obligations under the Rush/Acorda License.
7. Acorda agrees to indemnify Elan from and against any losses and liability arising from any claims made by Rush against Elan after the Effective Date resulting primarily from any acts or omissions of Acorda under the Rush/Acorda License. Elan shall give Acorda prompt notice of any such loss or liability, shall cooperate in its defense, and shall give Acorda full authority to defend and settle such claim on Elans behalf. This indemnity obligation shall not apply in the case of losses primarily caused by or based on (i) Elans acts or omissions; or (ii) any breach of this Rush Payments Agreement, the Side Agreement or the Elan/Acorda License by Elan.
In the event Elan has the right to and elects to cure any Acorda breach of, or assumes the rights and obligations of Acorda under the, Rush/Acorda License in accordance with the terms of the Side Agreement and this Rush Payments Agreement, Elan agrees to indemnify Acorda from and against any losses and liability arising from any claims made by Rush against Acorda resulting from any acts of Elan after the date that Elan cures such breach or assumes Acordas obligations under the Rush/Acorda License. Acorda shall give Elan prompt notice of any such loss or liability, shall cooperate in its defense, and shall give Elan full authority to defend and settle such claim on Acordas behalf. This indemnity obligation shall not apply in the case of losses primarily caused by or based on (i) Acordas acts or omissions; or (ii) any breach of this Rush Payments Agreement, the Side Agreement or the Elan/Acorda License by Acorda.
8. All notices or other communications which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:
if to Acorda to: |
ACORDA THERAPEUTICS, INC.. |
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15 Skyline Drive |
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Hawthorne, New York 10532 |
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Attention: President |
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Fax No.: 914.347.4560 |
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if to Elan to: |
ELAN CORPORATION, PLC. |
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c/o Elan International Services Ltd. |
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102 St. James Court |
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Flatts, |
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Smiths FL04 Bermuda |
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Attention: Secretary |
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Fax No: +1 441 292 2224 |
9. This Rush Payments Agreement shall be effective as of the date set forth below (Effective Date), and shall be governed by the laws of the State of New York without reference to any rules of conflict of laws. Any disputes under this Agreement shall be governed by the dispute resolution provisions of Article 12.14 of the Elan/Acorda License.
10. This Rush Payments Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
IN WITNESS WHEREOF, the Parties have executed this Rush Payments Agreement as of September 26, 2003.
ACORDA THERAPEUTICS, INC. |
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By: |
/s/ Ron Cohen |
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Name: |
Ron Cohen |
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Title: |
President and Chief Executive Officer |
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ELAN CORPORATION, PLC. |
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By: |
/s/ Pieter Bosse/Klaas Van Blanken |
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Name: |
Monksland Holdings BV |
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Title: |
Proxyholder |
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4
EXHIBIT A
RUSH/ACORDA LICENSE
(Filed as Exhibit 10.16 with this registration statement on Form S-1)
5
Exhibit 10.19
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk *, have been separately filed with the Commission.
AMENDMENT No. 1 TO
RUSH PAYMENTS AGREEMENT
THIS AMENDMENT, dated as of October 27, 2003, by and between Acorda Therapeutics, Inc. (Acorda) and Elan Corporation, plc. (Elan) amends the Rush Payments Agreement effective as of September 26, 2003 (the Payments Agreement) by and between Acorda and Elan.
W I T N E S S E T H:
WHEREAS, Acorda and Elan desire to amend certain provisions relating to the timing of payments under the Payments Agreement upon the terms and conditions set forth herein;
NOW, THEREFORE , in consideration of the premises contained herein, and for other good and valuable consideration, the adequacy and receipt of which are hereby acknowledged, the parties hereto agree as follows:
1. Paragraph 2 (a) of the Payments Agreement is hereby amended and restated in its entirety to read as follows:
(a) Each of Acorda and Elan shall be responsible for [**] of any milestone payments payable to Rush under Section 5.2 (a) or 5.2 (b) of the Rush/Acorda License. Accordingly, if the milestone events set forth in either Section 5.2 (a) or Section 5.2 (b) of the Rush/Acorda License are achieved, (x) Acorda shall so advise Elan in writing upon achievement of the applicable milestone event, and (y) Elan shall pay Acorda an amount equal to [**] of the applicable milestone payment within twenty-five (25) days after receipt of such notice as Elans share of such payment.
2. Paragraph 2 (b) of the Payments Agreement is hereby amended and restated in its entirety to read as follows:
(b) Elan shall be responsible for [**] of any milestone payments payable to Rush under Section 5.2 (c) of the Rush/Acorda License. Accordingly, if the milestone event set forth in Section 5.2 (c) of the Rush/Acorda License is achieved, Acorda shall so advise Elan in writing upon achievement of the applicable milestone event and Elan shall pay Acorda an amount equal to [**] of the applicable milestone payment within twenty-five (25) days after receipt of such notice.
3. Except as expressly amended by this Amendment, all of the provisions of the Payments Agreement shall remain in full force and effect. All references to the Payments Agreement, from and after the date hereof, shall be to the Payments Agreement as amended by this Amendment.
4. This Amendment may be executed in two or more counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same instrument.
IN WITNESS WHEREOF , the Parties have executed this Amendment as of the date first set forth above.
Acorda Therapeutics, Inc.
By: |
/s/ Ron Cohen |
Name: |
Ron Cohen |
Title: |
President and CEO |
Elan Corporation, plc .
By: |
/s/ Pieter Bosse/Klaas van Blanken |
Name: |
Monksland Holdings BV |
Title: |
Proxyholder |
2
Exhibit 10.20
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
AMENDED AND RESTATED LICENSE AGREEMENT
by and between
CANADIAN SPINAL RESEARCH ORGANIZATION
and
ACORDA THERAPEUTICS, INC.
THIS AMENDED AND RESTATED LICENSE AGREEMENT made as of August 1, 2003 (the Restatement Date), by and between CANADIAN SPINAL RESEARCH ORGANIZATION, a not-for-profit corporation organized and existing under the laws of Ontario and having its principal office at 120 Newkirk Road, Unit 2, Richmond Hill, Ontario, L4C 9S7 (CSRO) and ACORDA THERAPEUTICS, INC. , a corporation organized and existing under the laws of the State of Delaware and having its principal office at 16 Skyline Drive, Hawthorne, New York 10532 (ACORDA).
W I T N E S S E T H:
WHEREAS, CSRO owns or has rights to certain Patent Assets and Know How (each as defined herein) relating to the use of 4-aminopyridine (4-AP) in the reduction of chronic pain and spasticity in a spinal cord injured patient;
WHEREAS, CSRO, Purdue and McMaster have entered into that certain Inter-Institutional Agreement, effective as of October 18, 1993 (the Inter-Institutional Agreement), pursuant to which CSRO acquired the sole authority to license rights to any patents included in the Patent Assets;
WHEREAS, pursuant to the Assignments, CSRO obtained an Assignment from the Inventors of the Patent Assets (all as defined herein);
WHEREAS, pursuant to a License Agreement (the 1995 Agreement), effective August 9, 1995 (the 1995 Agreement Effective Date), between CSRO and ACORDA, CSRO granted ACORDA an exclusive license under the Patent Assets; and
WHEREAS, the Parties agree that the 1995 Agreement should be amended and restated to reflect the intentions of the Parties, effective as of the 1995 Agreement Effective Date, except where indicated to be effective as of the Restatement Date;
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, the Parties hereby agree that the 1995 Agreement, and all of the terms, conditions and provisions of the 1995 Agreement, are hereby superceded and replaced in their entirety by this Agreement and the terms, conditions and provisions hereof, effective as of the 1995 Agreement Effective Date, as follows:
Unless specifically set forth to the contrary herein, the following terms, where used in the singular or plural, shall have the respective meanings set forth below:
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Such know-how shall include, without limitation, all chemical, pharmaceutical, toxicological, preclinical, clinical, assay control, regulatory, and any other data or information used or useful for the development, manufacturing and/or regulatory approval of Compound or Product, including such rights which CSRO may have to data or information developed by Third Parties.
1.10. First Commercial Sale shall mean the first sale of Product by ACORDA, its Affiliate or its sublicensees in a country, for end use or consumption, after all required Regulatory Approvals have been granted by the governing health authority of such country. Sales for
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Sales or other transfers between ACORDA and its Affiliates or sublicensees shall be excluded from the computation of Net Sales and no payments will be payable on such sales or transfers except where such Affiliates are end users, but Net Sales shall include the subsequent sales to Third Parties by such Affiliates or sublicensees.
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5
6
7
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
(i) Subject to the terms and conditions of this Agreement, and in consideration of the rights granted by CSRO hereunder, ACORDA shall pay to CSRO royalties in an amount equal to [**] of Net Sales in each country in the Territory where the manufacture, use or sale of Product would, absent the license granted hereunder, infringe one or more Valid Claims in such country.
(ii) Royalties on Net Sales at the rate set forth in (i) above shall accrue as of the date of First Commercial Sale of Product in the applicable country and shall continue and accrue on Net Sales on a country-by-country basis until the earlier of (A) the expiration of the last to expire Patent Asset in such country or (B) ten (10) years following the date of First Commercial Sale of Product in such country. Thereafter, ACORDA shall be relieved of any royalty payment under this Agreement.
(iii) The payment of royalties set forth above shall be subject to the following conditions:
8
(A) only one payment shall be due with respect to the same unit of Product;
(B) no multiple royalties shall be payable because any Product, or its manufacture, sale or use is covered by more than one Valid Claim;
(C) no royalties shall accrue on the disposition of Product by ACORDA, Affiliates or sublicensees as samples (promotion or otherwise) or as donations (for example, to non-profit institutions or government agencies) or to clinical trials or for research and and/or development; and
(D) CSRO shall be responsible for payment of any royalties or other obligations owed by CSRO to any Third Party, including without limitation, pursuant to the Inter-Institutional Agreement.
9
10
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
11
12
13
14
15
16
17
18
19
if to ACORDA to:
ACORDA THERAPEUTICS, INC.
16 Skyline Drive
Hawthorne, New York 10532
Attention: Ron Cohen
Fax No.: (914) 347-4560
if to CSRO to:
CANADIAN SPINAL RESEARCH ORGANIZATION
120 Newkirk Road, Unit 2
Richmond Hill, Ontario L4C 9S7
Attention: Barry Munro
Fax No.: (905) 508-4002
or to such other address as the Party to whom notice is to be given may have furnished to the other Parties in writing in accordance herewith. Any such communication shall be deemed to have been given when delivered if personally delivered or sent by facsimile on a Business Day, upon confirmed delivery by nationally-recognized overnight courier if so
20
delivered and on the third Business Day following the date of mailing if sent by registered or certified mail.
21
Any mediation or arbitration proceeding entered into pursuant to this Section 10.6 shall be conducted in the English language. Subject to the foregoing, for purposes of this Agreement, each Party consents, for itself and its Affiliates, to the jurisdiction of the courts of the State of New York, county of New York and the U.S. District Court for the Southern District of New York.
22
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first set forth above.
CANADIAN SPINAL RESEARCH ORGANIZATION |
|||
|
|||
By: |
/s/ Barry Munro |
|
|
|
Name: |
Barry Munro |
|
|
Title: |
President |
|
|
|||
|
|||
A CORDA THERAPEUTICS, INC. |
|||
|
|||
By: |
/s/ Harold Safferstein |
|
|
|
Name: |
Harold Safferstein |
|
|
Title: |
VP of Business Development |
|
23
EXHIBIT 1.2
ASSIGNMENTS
24
Mail documents to be recorded with required cover sheet information to:
Assistant Commissioner For Patents
Box Assignments
Washington, D.C, 20231
ASSIGNMENT
WHEREAS, WE
ROBERT R. HANSEBOUT, a citizen of Canada, residing at 589 Scenic Drive, Hamilton, Ontario L9C 1H1; and
ANDREW R. BLIGHT, a citizen of Great Britain, residing at 3228 Gait Way, Chapel Hill, North Carolina 27516-7606
have invented certain new and useful improvements in
THE USE OF 4-AMINOPYKIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION
for which we have executed an Application for Letters Patent in the United States on even date herewith
WHEREAS, CANADIAN SPINAL RESEARCH ORGANIZATION,
with offices at 120 Newkirk Road, Unit 32, Richmond Hill, Ontario,
L4C 9S7 Canada
is desirous of obtaining the entire right, title and interest in, to and under the said improvements and the said application;
NOW, THEREFORE, FOR other good and valuable consideration, the receipt of which is hereby acknowledged, we the said
ROBERT R. HANSEBOUT and ANDREW R. BLIGHT
have sold, assigned, transferred and set over, and by these presents do hereby sell, assign, transfer and set over, to the said
CANADIAN SPINAL RESEARCH ORGANIZATION
its successors, legal representatives and assigns, the entire right, title and interest in, to and under the said improvements, and the said application and all divisions, renewals and continuations thereof, and all Letters Patent of the United States which may be granted thereon and all reissues and extensions thereof, and all applications for Letters Patent which may hereafter be filed for said improvements in any country or countries foreign to the United States, including the right to claim priority under the terms of any appropriate International Convention based upon said application for Letters Patent of the United States, and all Letters Patent which may be granted for said improvements in any country or countries foreign to the United States and extensions, renewals and reissues thereof; and we hereby authorize and request the Commissioner of Patents and Trademarks of the United States and any official of any country or countries foreign to the United States, whose duty it is to issue patents on applications as aforesaid, to issue all Letters Patent for said improvements to the said
CANADIAN SPINAL RESEARCH ORGANIZATION
its successors, legal representatives and assigns, in accordance with the terms of this instrument.
AND WE HEREBY covenant that we have full right to convey the interest herein assigned in the manner hereinabove set forth, and that we have not executed, and will not execute, any agreement in conflict herewith.
AND WE HEREBY further covenant and agree that we will communicate to the said
CANADIAN SPINAL RESEARCH ORGANIZATION
its successors, legal representatives and assigns, any fact known to us respecting said improvements, and testify in any legal proceeding, sign all lawful papers, execute all divisions, continuing and reissue applications, make all rightful oaths and generally do everything possible to aid the said
CANADIAN SPINAL RESEARCH ORGANIZATION
its successors, legal representatives and assigns, to obtain and enforce proper Patent Protection for said improvements in the United States.
IN TESTIMONY WHEREOF, we hereunto set our hand and seal the day and year set opposite our signatures.
Date |
|
, 19 |
/s/ Robert R. Hansebout |
L.S. |
|
|
ROBERT R. HANSEBOUT |
|
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|
|
|
|||
|
|
|
|||
Date |
October 20 |
, 1996 |
/s/ Andrew R. Blight |
L.S. |
|
|
ANDREW R. BLIGHT |
|
|||
2
ASSIGNMENT
WHEREAS, WE
ROBERT R. HANSEBOUT, a citizen of Canada, residing at 589 Scenic Drive, Hamilton, Ontario L9C 1H1; and
ANDREW R. BLIGHT, a citizen of Great Britain, residing at 3228 Gait Way, Chapel Hill, North Carolina 27516-7606
have invented certain new and useful improvements in
THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION
for which we have executed an Application for Letters Patent in the United States on even date herewith
WHEREAS, CANADIAN SPINAL RESEARCH ORGANIZATION,
with offices at 120 Newkirk Road, Unit 32, Richmond Hill, Ontario,
L4C 9S7 Canada
is desirous of obtaining the entire right, title and interest in, to and under the said improvements and the said application;
NOW, THEREFORE, FOR other good and valuable consideration, the receipt of which is hereby acknowledged, we the said
ROBERT R. HANSEBOUT and ANDREW R. BLIGHT
have sold, assigned, transferred and set over, and by these presents do hereby sell, assign, transfer and set over, to the said
CANADIAN SPINAL RESEARCH ORGANIZATION
its successors, legal representatives and assigns, the entire right, title and interest in, to and under the said improvements, and the said application and all divisions, renewals and continuations thereof, and all Letters Patent of the United States which may be granted thereon and all reissues and extensions thereof, and all applications for Letters Patent which may hereafter be filed for said improvements in any country or countries foreign to the United States, including the right to claim priority under the terms of any appropriate International Convention based upon said application for Letters Patent of the United States, and all Letters Patent which may be granted for said improvements in any country or countries foreign to the United States and extensions, renewals and reissues thereof; and we hereby authorize and request the Commissioner of Patents and Trademarks of the United States and any official of any country or countries foreign to the United States, whose duty it is to issue patents on applications as aforesaid, to issue all Letters Patent for said improvements to the said
CANADIAN SPINAL RESEARCH ORGANIZATION
its successors, legal representatives and assigns, in accordance with the terms of this instrument.
AND WE HEREBY covenant that we have full right to convey the interest herein assigned in the manner hereinabove set forth, and that we have not executed, and will not execute, any agreement in conflict herewith.
AND WE HEREBY further covenant and agree that we will communicate to the said
CANADIAN SPINAL RESEARCH ORGANIZATION
its successors, legal representatives and assigns, any fact known to us respecting said improvements, and testify in any legal proceeding, sign all lawful papers, execute all divisions, continuing and reissue applications, make all rightful oaths and generally do everything possible to aid the said
CANADIAN SPINAL RESEARCH ORGANIZATION
its successors, legal representatives and assigns, to obtain and enforce proper Patent Protection for said improvements in the United States.
IN TESTIMONY WHEREOF, we hereunto set our hand and seal the day and year set opposite our signatures.
Date |
|
, 19 |
|
L.S. |
|
ROBERT R. HANSEBOUT |
|
||
|
|
|
||
|
|
|
||
Date |
OCT 20 |
, 1996 |
/s/ Andrew R. Blight |
L.S. |
|
ANDREW R. BLIGHT |
|
2
DECLARATION AND POWER OF ATTORNEY FOR PATENT APPLICATION
As below named inventors, we hereby declare that:
Our residence, post office address and citizenship are as stated below under our name.
We believe that we are the original, first and sole inventors (if only one name is listed below) or an original, first and joint inventor (if plural names are listed below) of the subject matter which is claimed and for which a patent is sought on the invention entitled
THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A NEUROLOGICAL CONDITION
the Specification of which
|
ý |
is attached hereto |
|
|
o |
was filed on |
|
|
|
as Application Serial No. |
|
|
|
and was amended on |
(if applicable). |
We hereby state that we have reviewed and understand the contents of the above-identified Specification, including the claims, as amended by any amendment referred to above.
We acknowledge the duty to disclose information which is material to the examination of this application in accordance with Title 37, Code of Federal Regulations, 1.56(a).
We hereby claim foreign priority benefits under Title 35, United States Code, §119 of any foreign application(s) for patent or inventors certificate listed below and have also identified below any foreign application for patent or inventors certificate having a filing date before that of the application on which priority is claimed.
APPLICATION |
|
PRIOR FILED APPLICATIONS(S) |
|
PRIORITY |
|
||
NUMBER |
|
COUNTRY |
|
(DAY/MONTH/YEAR FILED) |
|
CLAIMED |
|
|
|
|
|
|
|
|
|
NONE |
|
|
|
|
|
|
|
We hereby claim the benefit under Title 35, United States Code, §120 of any United States application listed below, and, insofar as the subject matter of each of the claims of this application is not disclosed in any prior United States application in the manner provided by the first paragraph of Title 35, United States Code, §112, we acknowledge the duty to disclose material information as defined in Title 37, Code of Federal Regulations, §1.56(a), which occurred between the filing date of the prior application and the national or PCT international filing date of this application;
APPLICATION |
|
FILING DATE |
|
STATUS - PATENTED, PENDING, |
|
NO. |
|
(DAY/MONTH/YEAR) |
|
ABANDONED |
|
|
|
|
|
|
|
08/290,757 |
|
September 13, 1994 |
|
PENDING |
|
We hereby appoint as our attorneys or agents the following persons; Jack Matalon, (Attorney, Registration No. 22,441); Stefan J, Klauber, (Attorney, Registration No. 22,604); David A. Jackson (Attorney, Registration No. 26,742); Raymond M. Speer (Attorney, Registration No. 26,810); Barbara L. Renda (Attorney, Registration No. 27,626); Paul F. Fehlner (Attorney, Registration No. 35,135); Joseph M. Homa, (Attorney, Registration No. 40,023) and Michael D. Davis, (Attorney, Registration No. 39,161) said attorneys or agents to have full power of substitution and revocation to prosecute this application and transact all business in the Patent and Trademark Office connected therewith.
Please address all correspondence regarding this application to:
DAVID A. JACKSON, ESQ.
KLAUBER & JACKSON
411 HACKENSACK AVENUE
HACKENSACK, NEW JERSEY 07601
Direct all telephone calls to David A. Jackson at (201) 487-5800.
I hereby declare that all statements made herein of my own knowledge are true and that all statements made on information and belief are believed to be true; and further, that these statements were made with the knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the application or any patent issued thereon.
FULL NAME OF FIRST INVENTOR: |
ROBERT R. HANSEBOUT |
|
|||||
RESIDENCE: |
|
Hamilton, Ontario |
|||||
COUNTRY OF CITIZENSHIP: |
|
Canada |
|||||
POST OFFICE ADDRESS: |
|
589 Scenic Drive |
|||||
|
|
Hamilton, Ontario L9C 1H1 |
|||||
|
|||||||
SIGNATURE OF INVENTOR |
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|||||
|
|||||||
DATE |
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|||||
2
FULL NAME OF SECOND JOINT INVENTOR: |
ANDREW R. BLIGHT |
|||||
RESIDENCE: |
|
Chapel Hill, North Carolina |
||||
COUNTRY OF CITIZENSHIP: |
|
Great Britain |
||||
POST OFFICE ADDRESS: |
|
3228 Gait Way |
||||
|
|
Chapel Hill, North Carolina 27516-7606 |
||||
|
||||||
|
||||||
SIGNATURE OF INVENTOR |
/s/ Andrew R. Blight |
|
||||
|
||||||
DATE |
Oct 20, 1996 |
|
||||
3
DECLARATION AND POWER OF ATTORNEY FOR PATENT APPLICATION
As below named inventors, we hereby declare that:
Our residence, post office address and citizenship are as stated below under our name.
We believe that we are the original, first and sole inventors (if only one name is listed below) or an original, first and joint inventor (if plural names are listed below) of the subject matter which is claimed and for which a patent is sought on the invention entitled
THE USE OF 4-AMINOPYRIDINE IN THE TREATMENT OF A
NEUROLOGICAL CONDITION
the Specification of which
|
ý |
is attached hereto |
|
|
o |
was filed on |
|
|
|
as Application Serial No. |
|
|
|
and was amended on |
(if applicable). |
We hereby state that we have reviewed and understand the contents of the above-identified Specification, including the claims, as amended by. any amendment referred to above.
We acknowledge the duty to disclose information which is material to the examination of this application in accordance with Title 37, Code of Federal Regulations, 1.56(a).
We hereby claim foreign priority benefits under Title 35, United States Code, §119 of any foreign application(s) for patent or inventors certificate listed below and have also identified below any foreign application for patent or inventors certificate having a filing date before that of the application on which priority is claimed.
APPLICATION |
|
PRIOR FILED APPLICATIONS(S) |
|
PRIORITY |
|
||
NUMBER |
|
COUNTRY |
|
(DAY/MONTH/YEAR FILED) |
|
CLAIMED |
|
|
|
|
|
|
|
|
|
NONE |
|
|
|
|
|
|
|
We hereby claim the benefit under Title 35, United States Code, §120 of any United States application listed below, and, insofar as the subject matter of each of the claims of this application is not disclosed in any prior United States application in the manner provided by the first paragraph of Title 35, United States Code, §112, we acknowledge the duty to disclose material information as defined in Title 37, Code of Federal Regulations, §1.56(a), which occurred between the filing date of the prior application and the national or PCT international filing date of this application:
APPLICATION |
|
FILING DATE |
|
STATUS - PATENTED, PENDING, |
|
NO. |
|
(DAY/MONTH/YEAR) |
|
ABANDONED |
|
|
|
|
|
|
|
08/290,757 |
|
September 13, 1994 |
|
PENDING |
|
We hereby appoint as our attorneys or agents the following persons: Jack Matalon, (Attorney, Registration No. 22,441); Stefan J. Klauber, (Attorney, Registration No. 22,604); David A. Jackson (Attorney, Registration No. 26,742); Raymond M. Speer (Attorney, Registration No. 26,810); Barbara L. Renda (Attorney, Registration No. 27,626); Paul F. Fehlner (Attorney, Registration No. 35,135); Joseph M. Homa, (Attorney, Registration No, 40,023) and Michael D. Davis, (Attorney, Registration No. 39,161) said attorneys or agents to have full power of substitution and revocation to prosecute this application and transact all business in the Patent and Trademark Office connected therewith.
Please address all correspondence regarding this application to:
DAVID A. JACKSON, ESQ.
KLAUBER & JACKSON
411 HACKENSACK AVENUE
HACKENSACK, NEW JERSEY 07601
Direct all telephone calls to David A. Jackson at (201) 487-5800.
I hereby declare that all statements made herein of my own knowledge are true and that all statements made on information and belief are believed to be true; and further, that these statements were made with the knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under Section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the application or any patent issued thereon,
FULL NAME OF FIRST INVENTOR: |
ROBERT R. HANSEBOUT |
|||||
RESIDENCE: |
Hamilton, Ontario |
|||||
COUNTRY OF CITIZENSHIP: |
Canada |
|||||
POST OFFICE ADDRESS: |
589 Scenic Drive |
|||||
|
Hamilton, Ontario L9C 1HI |
|||||
|
||||||
|
||||||
SIGNATURE OF INVENTOR |
/s/ R. Hansebout |
|
||||
|
||||||
DATE |
Oct. 16, 1996 |
|
||||
2
3
SCHEDULE 1.6
DIAGRAM OF 4-AP
4-aminopyridine (4-AP), C5H6N2, MW 94
25
SCHEDULE
1.16
PATENT ASSETS
Case Number: A01
Title: |
USE OF 4-AMINOPYRIDINE
IN THE REDUCTION OF CHRONIC
|
Inventor(s): |
|
Hansebout, Robert R.
|
|
Client: |
Acorda Therapeutics Inc. |
|
Owner: |
Canadian Spinal Research Organization |
|
Disclosure Status: |
Filed |
|
Disclosure Date: |
|
|
Attorney(s): |
MF |
|
Country |
|
Sub Case |
|
Case Type |
|
Status |
|
Application Number |
|
Filing Date |
|
Patent Number |
|
Issue Date |
|
Expiration Date |
|
Australia |
|
|
|
PCT |
|
Granted |
|
56911/94 |
|
20-Dec-1993 |
|
676251 |
|
06-Mar-1997 |
|
18-Dec-2012 |
|
Austria |
|
|
|
PCT |
|
Granted |
|
1993094902578 |
|
20-Dec-1993 |
|
0241981 |
|
15-Jun-2003 |
|
20-Dec-2013 |
|
Bulgaria |
|
|
|
PCT |
|
Granted |
|
99047 |
|
20-Dec-1993 |
|
62272 |
|
12-Nov-1998 |
|
20-Dec-2013 |
|
Canada |
|
|
|
PCT |
|
Pending |
|
2085785 |
|
20-Dec-1993 |
|
|
|
|
|
18-Dec-2012 |
|
Czech Republic |
|
|
|
ORD |
|
Granted |
|
PV2254-94 |
|
20-Dec-1993 |
|
284441 |
|
11-Nov-1998 |
|
20-Dec-2013 |
|
European Patent Convention |
|
|
|
PCT |
|
Granted |
|
94902578.7 |
|
20-Dec-1993 |
|
0626848 |
|
04-Jun-2003 |
|
20-Dec-2013 |
|
France |
|
|
|
EPC |
|
Granted |
|
94902578.7 |
|
20-Dec-1993 |
|
0626848 |
|
04-Jun-2003 |
|
20-Dec-2013 |
|
Germany, Federal Republic of |
|
|
|
EPC |
|
Granted |
|
94902578.7 |
|
20-Dec-1993 |
|
69333014 |
|
04-Jun-2003 |
|
20-Dec-2013 |
|
Hungary |
|
|
|
PCT |
|
Granted |
|
P94-02647 |
|
20-Dec-1993 |
|
219583 |
|
02-Aug-2001 |
|
20-Dec-2013 |
|
Ireland |
|
|
|
EPC |
|
Granted |
|
94902578.7 |
|
20-Dec-1993 |
|
0626848 |
|
04-Jun-2003 |
|
20-Dec-2013 |
|
Italy |
|
|
|
EPC |
|
Granted |
|
94902578.7 |
|
20-Dec-1993 |
|
0626848 |
|
04-Jun-2003 |
|
20-Dec-2013 |
|
Japan |
|
|
|
PCT |
|
Granted |
|
6-514637 |
|
20-Dec-1993 |
|
8504772 |
|
21-May-1996 |
|
20-Dec-2013 |
|
Korea, Democratic Peoples Republic of |
|
|
|
PCT |
|
Granted |
|
P-94-354 |
|
20-Dec-1993 |
|
31250 |
|
30-Aug-1997 |
|
20-Dec-2013 |
|
Korea, Republic of |
|
|
|
PCT |
|
Granted |
|
94-702838 |
|
20-Dec-1993 |
|
10-301415 |
|
25-Jun-2001 |
|
20-Dec-2013 |
|
Liechtenstein |
|
|
|
EPC |
|
Granted |
|
94902578.7 |
|
20-Dec-1993 |
|
0626848 |
|
04-Jun-2003 |
|
20-Dec-2013 |
|
Netherlands |
|
|
|
EPC |
|
Granted |
|
94902578.7 |
|
20-Dec-1993 |
|
0626848 |
|
04-Jun-2003 |
|
20-Dec-2013 |
|
New Zealand |
|
|
|
PCT |
|
Granted |
|
258844 |
|
20-Dec-1993 |
|
258844 |
|
09-Oct-2000 |
|
20-Dec-2013 |
|
Norway |
|
|
|
PCT |
|
Granted |
|
1994 3049 |
|
20-Dec-1993 |
|
308.644 |
|
09-Oct-2000 |
|
20-Dec-2013 |
|
Russian Federation |
|
|
|
PCT |
|
Granted |
|
94041207.00 |
|
20-Dec-1993 |
|
2160590 |
|
20-Oct-2000 |
|
20-Dec-2013 |
|
Singapore |
|
|
|
PCT |
|
Granted |
|
9705418-3 |
|
19-Apr-1996 |
|
48615 |
|
20-Jul-1999 |
|
19-Apr-2016 |
|
Slovakia |
|
|
|
PCT |
|
Granted |
|
PV-0969-94 |
|
20-Dec-1993 |
|
280922 |
|
24-May-2000 |
|
20-Dec-2013 |
|
Spain |
|
|
|
EPC |
|
Granted |
|
94902578.7 |
|
20-Dec-1993 |
|
0626848 |
|
04-Jun-2003 |
|
20-Dec-2013 |
|
Sweden |
|
|
|
EPC |
|
Granted |
|
94902578.7 |
|
20-Dec-1993 |
|
0626848 |
|
04-Jun-2003 |
|
20-Dec-2013 |
|
United Kingdom |
|
|
|
EPC |
|
Granted |
|
94902578.7 |
|
20-Dec-1993 |
|
0626848 |
|
04-Jun-2003 |
|
20-Dec-2013 |
|
United States of America |
|
|
|
ORD |
|
Granted |
|
08/290757 |
|
13-Sep-1994 |
|
5545648 |
|
13-Aug-1996 |
|
13-Sep-2014 |
|
Abstract: A method of reducing chronic pain and spasticity in a spinal cord injured patient in need of such treatment comprising administering an effective amount of 4-aminopyridine to said patient.
26
EXHIBIT 1.2
ASSIGNMENTS
24
EXHIBIT 6.1(o)
INTER-INSTITUTIONAL AGREEMENT
INTER-INSTITUTIONAL AGREEMENT
THIS AGREEMENT made the 18th day of October,1993, is by and between PURDUE RESEARCH FOUNDATION (hereinafter PRF), McMASTER UNIVERSITY (hereinafter McMaster) and the CANADIAN SPINAL RESEARCH ORGANIZATION, a not-for-profit organization (here in after CSRO)
WHEREAS, Dr. Blight and Dr. Hansebout have jointly invented technology relating to the utility of the chemical compound 4-aminopyridine in the therapy of human patients with spinal cord injury as described in attachment 1 of this agreement (hereinafter the Technology).
WHEREAS at the time of inventing the Technology, Dr. Blight was employed by Purdues University and is under an obligation to transfer all his rights in the technology to PRF, and Dr. Hansebout was employed by McMaster and is under an obligation to transfer all his rights in the Technology to McMaster.
WHEREAS CSRO provided funding for the research resulting in invention of the Technology and agree to be responsible for filing patent applications on the technology.
WHEREAS Dr. Blight and Dr. Hansebout, PRF, and McMaster desire to license the Technology to benefit the public, to provide support to CSRO for further spinal cord research, and to cover the cost of filing, prosecuting and maintaining patent applications on the Technology.
NOW, THEREFORE, in consideration of the premises and mutual covenants contained herein, the parties hereto agree as follows,
1. DEFINITION: Patent Rights, as used herein shall mean rights in and to any patent applications, in any jurisdiction
and any all divisions, continuations, continuations in part, reissues, re-examinations or extensions thereof, and any letters patent that issue thereon they make claims relating to all or part of the Technology.
2. CSRO, at its own expense and using counsel of its choice, may file, prosecute, and maintain applications and patents on the patent rights. Applications may be filed in Canada, the United States of America and countries foreign thereon. CSRO shall solicit PRFs and McMasters input on all patent matters relating to the Patent Rights including providing PRF and McMaster with copies of all applications and response to Examiners action before transmittal and providing PRF and McMaster with copies of all examiners actions and other patent related correspondence in a timely fashion after receipt. In the event that CSRO elects not to file patent applications in Canada or the United States or to abandon applications filed in any country, CSRO shall provide written notice to PRF and McMaster of its decision at least forty-five (45) days prior to any patentability bar date or due date. If PRF or McMaster desire to file, continue prosecution or maintain such application(s) or letters patent(s), any rights of CSRO under this agreement relating to the aspect of the Technology claimed in said application(s) or letter patent(s) shall cases. If PRF and/or McMaster are interested in continuing with the patenting process with respect to said application(s) or letters patent(s), they shall negotiate a separate agreement in good faith.
3. The parties agree that CSRO shall have the sole authority to license any Patent Rights under this agreement, CSRO may, in good faith and in its sole discretion, negotiate a suitable licensing agreement including, without limiting the generality of the foregoing a royalty bearing, exclusive, World-Wide license to the Patent Rights, and has the authority to include provision in any such license agreement for the licensee
2
to pay the expense of, and have control with respect to, filing, prosecuting, and maintaining patent application(s) and letters patent(s) on the patent rights subject to the rights of PRF and McMaster to be kept informed and have an opportunity to give input on all patent better and to file, continue prosecution and maintenance of such application(s) or letters patent(s) as their own expense should CSRO and the licenses elect not to file, continue to prosecute, or maintain said application(s) or letters patent(s). The right to negotiate a licensing agreement extends to any entity that controls, is controlled by or under common control with CSRO.
4. CSRO shall commit itself to using good faith efforts to develop the Technology into commercial products. Such good faith efforts shall include taking positive steps to attempt to license the Technology for commercial exploitation thereof.
5. Gross Income with respect to the Technology or any patent or patent application covering all or part of the Technology shall be deemed to consist of money actually received by CSRO through the licensing of the Technology to others less any reasonable future expenses incurred in administering licenses for the technology, Divisible Income shall be deemed to consist of simulative Gross Income in excess of $25,000 cdn., (an amount agreed by the parties to repay a portion of CSROs costs in filing, prosecuting and maintaining application(s) and letters patent(s) licensing costs, and the cost of past and future research with respect to the Technology. CSRO shall pay over to each of PRF and McMaster, an amount equal to twenty-five percent (25%) of divisible Income payable as Divisible Income is received, but not more often than quarterly.
6. PRF and McMaster shall be responsible, and solely shall be responsible, for paying to their respective inventors such share of the royalties attributable to the inventions of the
3
inventors as is customary under their rules and practices, except as provided for in paragraph 7 below.
7. The term of this agreement shall extend for so long as any letters patent covered by the agreement remain unexpired or any patent application covered by the agreement remains pending in any Patent Office. However, any party may elect to withdraw from the agreement and forego any benefits extending to it under the agreement, in which case, so long as CSRO is not the withdrawing party, CSRO shall have the sale right to any income thereafter received from any licenses with respect to Patent Rights. With respect to income which would otherwise have been due to the withdrawing party, CSRO shall pay to the inventor associated with that party such share of the royalties attributable to the inventions of the inventor as is customary under the rules or practices of the withdrawing party. If CSRO elects to withdraw from the agreement, income which would otherwise go to CSRO shall be equally divided between PRF and McMaster.
8. PRF and McMaster make no representations and extend no warranties of any kind, either expressed or implied, including, but not limited to, warranties of merchantability, fitness for a particular purpose, and validity of Patent Rights claims, issued or pending.
9. Except for assignment to an affiliated organization, rights under this agreement shall not be assignable, and any attempt to do so shall be void.
10. PRF and McMaster agree to cooperate with CSRO in all reasonable ways with respect to obtaining patents on the Technology, licensing the technology and enforcing rights therein. These obligations shall extend to include obtaining inventors signatures on relevant documents, inventor review of
4
the application, Office actions, and the like, providing signatures by appropriate signing authorities necessary to enter into a reasonable licensing agreement and being added as a party to an action; in the courts in the event that it is necessary to litigate on the patent.
IN WITNESS WHEREOF, the parties who have caused this agreement to be executed in duplicate by their duly authorized representatives.
MCMASTER UNIVERSITY |
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/s/ Mark R. McDermott |
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Oct. 21/93 |
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Mark R. McDermott |
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Date: |
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Director, Officer of
Research
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PURDUE RESEARCH FOUNDATION |
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/s/ Robert R. Greenkorn |
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NOV 8 1983 |
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ROBERT R. GREENKORN |
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Date: |
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Vice President for Programs |
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CANADIAN
SPINAL RESEARCH
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/s/ Ray Wickson |
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October 21, 1993 |
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Ray Wickson |
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Date: |
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President |
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5
Exhibit 10.21
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (the Agreement ) is made and entered into as of this 3rd day of February, 2003 (the Effective Date ) by and between ACORDA THERAPEUTICS, INC. , a corporation organized and existing under the laws of the state of Delaware having a principal place of business at 15 Skyline Drive, Hawthorne, New York 10532 ( Acorda ) and CORNELL RESEARCH FOUNDATION, INC. , a non-profit corporation organized and existing under the laws of the state of New York having an office at 20 Thornwood Drive, Suite 105, Ithaca, NY 14850 ( Foundation ). Each of Acorda and Foundation may be referred to herein individually as a Party and collectively, as Parties .
RECITALS
WHEREAS , Foundation owns all right, title and interest in U.S. Patent No. 5,952,357; and
WHEREAS, Foundation is a wholly owned subsidiary of Cornell University (Cornell) and holds the ownership interests of patents, know-how, and biological materials made by Cornells employees and administers licenses in a manner consistent with the policies of Cornell; and
WHEREAS, Acorda desires to obtain and Foundation wishes to grant to Acorda, an exclusive license to U.S. Patent No. 5,952,357, including all intellectual property rights therein, for the development and commercialization of pharmaceutical products for all purposes; and
WHEREAS, the work leading to the Licensed Patents was supported in part by an agency of the U.S. Government, and Foundation is obligated to comply with U.S. OMB Circular A-124 and 37 CFR Part 401; and as such, this license is subject to the applicable terms of U.S. Government regulations concerning Government funded inventions.
NOW, THEREFORE , for and in consideration of the mutual covenants and the premises herein contained, the Parties, intending to be legally bound, hereby agree as follows:
The following terms as used herein shall have the following meanings:
2
3
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
4
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Event |
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(i) The effective date of a successful reissuance or reexamination of the Licensed Patents ( Milestone 1 ). |
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(ii) The date of completion of a Clinical Trial testing the use of Fampridine-SR in Amyotrophic Lateral Sclerosis (ALS), provided that such Clinical Trial shall be initiated at Acordas discretion and a negative or non-statistically significant trial would not trigger this milestone ( Milestone 2 ). |
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No milestone payment shall be paid more than once to Foundation pursuant to this Section 3.4. Milestone 1 and Milestone 2 are independent of each other and Milestone 2 may occur prior to Milestone 1. In any event, Acorda shall pay the specified milestone payment only upon the occurrence of the corresponding milestone event, regardless of the order of occurrence of the milestone events.
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Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other, except a Party may make such an assignment without the other Partys written consent to an Affiliate or to a successor to all, or substantially all, of the business to which this Agreement relates of such Party, whether in a merger, sale of stock, sale of assets or other transaction. Any permitted successor or assignee of rights and/or obligations hereunder shall, in writing to the other Party, expressly assume
12
performance of such rights and/or obligations. Any permitted assignment shall be binding on the successors of the assigning Party. Any assignment or attempted assignment by either Party in violation of the terms of this Article 11 shall be null and void and of no legal effect.
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IN WITNESS WHEREOF, Acorda and Foundation have caused this Agreement to be signed, under seal, by their duly authorized representatives below.
ACORDA THERAPEUTICS, INC. |
CORNELL RESEARCH FOUNDATION, INC. |
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/s/ Harold T. Safferstein |
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By: |
/s/ Brian Kelly |
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Name: |
Harold T. Safferstein |
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Name: |
Brian Kelly |
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Vice President, Business Development |
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Title: |
Vice President |
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16
TABLE OF CONTENTS
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i
APPENDIX A - ROYALTY REPORT
Report royalty payment information to the Cornell Research Foundation, Inc (CRF) using the report format or facsimile attached to these instructions. This minimal information must be provided in order to correctly record royalty related events required by your license agreement with CRF.
Use a separate report to record royalty information for each license agreement. For each licensee agreement, report royalty sales by CRF docket number, which identifies the technology. List each contributing technology if more than one technology is used to produce a royalty generating process/product. This level of detail permits evaluation of the use of each technology under license with your company.
Submit this information along with appropriate payment to:
Cornell Research
Foundation, Inc.
ATTN: Finance and Accounting
20 Thornwood Drive, Suite 105
Ithaca, NY 14850
(607) 257-1081
www.crf.cornell.edu
For your convenience,
payments may be made by FEDWIRE or ACH to:
Tompkins Trust Company
The Commons
Ithaca, NY 14851
(607) 273-3210
www.tompkinstrust.com
Account: 01-101-007353, ABA: 021302648
ROYALTY REPORT [licensee NAME]
LICENSEE NAME: |
CRF LICENSE NUMBER: |
REPORTING PERIOD:
Individual to contact concerning this information:
Name: |
Phone # or email ID: |
For each product/item subject to a royalty payment provision, provide the following information as applicable.
PRODUCT/ITEM:
CRF Docket Number |
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Country |
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Number of
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Gross Sales By
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Net Sales By
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Less Minimum Royalty
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Net Royalty
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Total Payment |
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3
Exhibit 10.22
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (the Agreement) is made and entered into as of November 12, 2002 (the Effective Date), by and between Acorda Therapeutics, Inc., a corporation organized and existing under the laws of the State of Delaware and having a principal place of business at 15 Skyline Drive, Hawthorn, New York, USA 10532 (Acorda), and CeNeS Pharmaceuticals, PLC, a corporation organized and existing under the laws of the United Kingdom and having a principal place of business at Compass House, Vision Park, Chivers Way, Histon, Cambridge CB4 9ZR, England (CeNeS).
WHEREAS, CeNeS is the exclusive licensee of certain intellectual property rights pursuant to that certain agreement, as amended, entered into by and between the Ludwig Institute for Cancer Research (Ludwig) and Cambridge Neuroscience Research, Inc. dated October 26, 1989 (the Ludwig Agreement);
WHEREAS, CeNeS and Acorda are parties to that certain License Option Agreement dated as of April 3, 2002, as amended, (the License Option Agreement), pursuant to which CeNeS granted Acorda the option to take a sublicense of certain rights licensed to CeNeS under the Ludwig Agreement; and
WHEREAS, Acorda desires to exercise such option and to take a sublicense of such rights as set forth herein,
NOW, THEREFORE, intending to be legally bound and upon the terms, conditions and mutual covenants hereinafter set forth, the parties agree as follows:
Part 1 - Definitions
2
Net Sales also includes the fair market value of any non-cash consideration received by Acorda or Sublicensees for the Sale, lease, or transfer of Licensed Products. The fair market value will be no less than the standard selling price for the applicable Licensed Products, each unit multiplied by the quantity of such Licensed Products delivered in exchange for such non-cash consideration.
3
4
Part 2 - License Grant
2.1 CeNeS hereby grants to Acorda, and Acorda accepts, an exclusive license under the Patent Rights and Licensed Know-How to practice the same and to make, have made, use, import, offer for sale and sell Licensed Products throughout the Territory during the term of this Agreement.
5
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
2.2 Acorda hereby acknowledges that CeNeS is obligated to pay Ludwig certain royalties with respect to Sales by Acorda and Acorda hereby agrees to be amenable to suit by Ludwig in the event of non-payment of royalties due CeNeS hereunder by Acorda. If Ludwig is required to bring suit against Acorda for any material breach of this Agreement that remains uncured pursuant to Section 9.3(a), Acorda will pay all reasonable out-of-pocket costs incurred by Ludwig in connection therewith, including without limitation, reasonable attorneys fees and costs.
Part 3 - Royalties
Annual Net Sales in USD |
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Royalty Rate |
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[**] |
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6
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
(b) If Acorda is required to pay a running royalty to a third party for a license to make, use, offer for sale, sell or import any Protein Product, then Acorda shall have the right to offset up to [**] of such royalties actually paid to such third party against royalties otherwise due under the foregoing Paragraph 3.2(a); provided, however, that such right of offset shall be limited such that - the royalty due under Paragraph 3:2(b) shall not be less than [**] of annual Net Sales of Protein Products and provided further that the amount of the offset which is not available due to such [**] cap cannot be carried-forward for application against future royalties due under Paragraph 3.2(a).
7
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
8
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Milestone Event |
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Milestone Payment |
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Satisfactory completion of animal toxicology studies necessary to enter into Phase I clinical studies in accordance with the International Conference of Harmonization (ICH) guidelines provided by the US Food and Drug Administration* |
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Issuance of an Investigational New Drug Application (or foreign equivalent**) |
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Enrollment of the first subject in a Phase II clinical trial (or foreign equivalent**) |
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Enrollment of the first subject in a Phase III clinical trial (or foreign equivalent**) |
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Filing of a New Drug Application (or foreign equivalent**) |
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Approval of a New Drug Application (or foreign equivalent**) |
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* Completion of animal toxicology studies shall mean the completion of all analysis of data generated in such study and delivery of the final report thereon.
** Foreign equivalent shall mean the completion of the milestones in a foreign major market country such as the United Kingdom, Japan, Germany, Canada, etc.
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11
Part 4 - Patent Matters
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Part 5 - Patent Infringement
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Part 6 - Diligence
Part 7 - Indemnification and Insurance
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Part 8 - Representations and Warranties
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Part 9 - Term and Early Termination
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Part 10 - Confidentiality
For purposes of this Agreement, all such information and data which a party is obligated to retain in confidence shall be called Information . Any written information, materials or data relating to GGF-2 disclosed by one party to the other party pursuant to the License Option Agreement and the Confidentiality Agreement entered into as of July 23, 2001 shall be deemed Information under this Agreement.
18
Each party, its Affiliates or sublicensees may disclose Information to regulatory authorities to the extent that such disclosure is necessary for the prosecution and enforcement of patents, authorizations to conduct clinical trials or commercialization of Licensed Products, provided that such party is otherwise entitled to engage in such activities under this Agreement. Each party, its Affiliates or sublicensees may disclose Information to the government or a court of competent jurisdiction, provided that such disclosing party (a) provides the other party with adequate notice of the required disclosure, (b) cooperates with the other partys efforts to protect its Information with respect to such disclosure and (c) takes all reasonable measures requested by the other party to challenge or to modify the scope of such required disclosure. CeNeS may disclose Information to Ludwig to the extent such disclosure is required pursuant to CeNeS obligations under the Ludwig Agreement.
19
Part 11 - General Provisions
20
21
If to Acorda: |
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Acorda Therapeutics, Inc, |
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15 Skyline Drive |
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Hawthorne, NY 10532 |
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Attn: President and Chief Executive Officer |
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with a copy to: |
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Acorda Therapeutics, Inc. |
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15 Skyline Drive |
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Hawthorne, NY 10532 |
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Attn: Harold Safferstein, Vice President, Business Development |
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If to CeNeS: |
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CeNeS Pharmaceuticals plc |
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Compass House |
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Vision Park |
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Clovers Way |
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Histon, Cambridge CI4 9ZR |
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England |
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Attn: Neil Clark, Chief Operating Officer and Finance Director |
By such notice either party may change their address for future notices. Notices delivered in person shall be deemed given on the date delivered. Notices sent by fax shall be deemed given on the date faxed. Notices mailed shall be deemed given two (2) days after the date postmarked on the envelope.
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23
IN WITNESS WHEREOF, CeNeS and Acorda have caused this Agreement to be executed in duplicate by their respective duty authorized officers.
CeNeS PHARMACEUTICALS, PLC |
ACORDA THERAPEUTICS, INC. |
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By: |
/s/ Neil Clark |
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By: |
/s/ Harold T. Safferstein |
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Print Name: |
Neil Clark |
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Print Name: |
Harold T. Safferstein |
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Title: |
Finance Director |
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Title: |
VP Business Development |
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24
SCHEDULE A
PATENT RIGHTS
Granted Patent List
Matter
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Country |
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Patent
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Grant
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Filing
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Status |
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Inventors |
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04585-002AU5 |
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Australia |
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688270 |
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02-Jul-1998 |
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29-Jun-1993 |
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Granted |
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Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
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04585-002AU6 |
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Australia |
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709968 |
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23-Dec-1999 |
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25-May-1995 |
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Granted |
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Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
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04585-002AUX |
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Australia |
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703772 |
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15-Jul-1999 |
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09-Oct-1996 |
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Granted |
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Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
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04585-002EP1 |
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Europe |
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0579640 |
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24-Jul-2002 |
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03-Apr-1992 |
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Granted |
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Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
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04585-002KR1 |
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Korea |
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274305 |
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08-Sep-2000 |
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03-Apr-1992 |
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Granted |
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Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
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04585-002KR5 |
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Korea |
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307943 |
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25-Aug-2001 |
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29-Jun-1993 |
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Granted |
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Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
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04585-002KR6 |
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Korea |
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265928 |
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09-Jun-2000 |
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25-May-1995 |
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Granted |
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Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
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04585-002KR7 |
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Korea |
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297680 |
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24-May-2001 |
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25-May-1995 |
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Granted |
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Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
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04585-002KR8 |
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Korea |
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344006 |
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28-Jun-2002 |
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29-Jun-1993 |
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Granted |
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Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
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04585-002PT1 |
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Portugal |
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100344 |
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02-May-1999 |
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03-Apr-1992 |
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Granted |
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Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
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04585-002PT5 |
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Portugal |
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101297 |
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07-Jul-1999 |
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30-Jun-1993 |
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Granted |
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Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
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04585-002005 |
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United States |
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5,530,109 |
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25-Jun-1996 |
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24-Mar-1993 |
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Granted |
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Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
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|
|
04585-002006 |
|
United States |
|
5,716,930 |
|
10-Feb-1998 |
|
26-May-1994 |
|
Granted |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
04585-002007 |
|
United States |
|
5,621,081 |
|
15-Apr-1997 |
|
06-Jun-1995 |
|
Granted |
|
Andrew D.J. Goodearl et al. |
Matter
|
|
Country |
|
Patent
|
|
Grant
|
|
Filing
|
|
Status |
|
Inventors |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
04585-002009 |
|
United States |
|
5,606,032 |
|
25-Feb-1997 |
|
06-Jun-1995 |
|
Granted |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
04585-00200A |
|
United States |
|
5,792,849 |
|
11-Aug-1998 |
|
06-Jun-1995 |
|
Granted |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
04585-00200G |
|
United States |
|
5,602,096 |
|
11-Feb-1997 |
|
06-Jun-1995 |
|
Granted |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
04585-00200J |
|
United States |
|
6,204,241 |
|
20-Mar-2001 |
|
22-Oct-1996 |
|
Granted |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
04585-00200L |
|
United States |
|
6,194,377 |
|
27-Feb-2001 |
|
22-Oct-1996 |
|
Granted |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
04585-00200P |
|
United States |
|
5,854,220 |
|
29-Dec-1998 |
|
22-Oct-1996 |
|
Granted |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
04585-002ZA1 |
|
South Africa |
|
92/2001 |
|
25-Nov-1992 |
|
01-Apr-1992 |
|
Granted |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
04585-002ZA5 |
|
South Africa |
|
93/4711 |
|
31-Aug-1994 |
|
30-Jun-1993 |
|
Granted |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
04585-039AU1 |
|
Australia |
|
713384 |
|
16-Mar-2000 |
|
27-Mar-1996 |
|
Granted |
|
Thomas A. Reh et al. |
Title: METHODS OF TREATING DISORDERS OF THE EYE |
Matter
|
|
Patent
|
|
Grant
|
|
Grant
|
|
Filing
|
|
Status |
|
Inventors |
|
|
|
|
|
|
|
|
|
|
|
|
|
04585-04AU1 |
|
Australia |
|
707599 |
|
28-Oct-1999 |
|
16-Nov-1995 |
|
Granted |
|
David I. Gwynne et al. |
Title: USE OF NEUREGULIN AS MODULATORS OF CELLULAR COMMUNICATION |
||||||||||||
|
||||||||||||
04585-041001 |
|
United States |
|
6,087,323 |
|
11-Jul-2000 |
|
17-Nov-1994 |
|
Granted |
|
David I. Gwynne et al. |
Title: USE OF NEUREGULIN AS MODULATORS OF CELLULAR COMMUNICATION |
||||||||||||
|
||||||||||||
04585-043AU2 |
|
Australia |
|
727037 |
|
15-Mar-2001 |
|
12-Nov-1996 |
|
Granted |
|
Mark Marchionni et al. |
Title: METHODS OF TREATING DISORDERS OF NON-VISUAL SENSORY EPITHELIA |
||||||||||||
|
||||||||||||
04585-048AU2 |
|
Australia |
|
745324 |
|
21-Mar-2002 |
|
08-Oct-1998 |
|
Natl Phase |
|
R. McBurney et al. |
Title: THERAPEUTIC METHODS COMPRISING USE OF A NEUREGULIN |
||||||||||||
|
||||||||||||
04585-051001 |
|
United States |
|
5,594,114 |
|
14-Jan-1997 |
|
17-Aug-1992 |
|
Granted |
|
Andrew D.J. Goodearl et al. |
Title: SCHWANN CELL MITOGENIC FACTOR, ITS PREPARATION AND USE |
2
Pending Patent Application List
Matter
|
|
Country |
|
Application
|
|
Filing
|
|
Status |
|
Inventors |
|
|
|
|
|
|
|
|
|
|
|
04585-002CA1 |
|
Canada |
|
2,108,199 |
|
03-Apr-1992 |
|
Pending |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||
|
|
|
|
|
|
|
|
|
|
|
04585-002CA5 |
|
Canada |
|
2,139,136 |
|
29-Jun-1993 |
|
Pending |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||
|
|
|
|
|
|
|
|
|
|
|
04585-002CA6 |
|
Canada |
|
2,191,085 |
|
25-May-1995 |
|
Pending |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||
|
|
|
|
|
|
|
|
|
|
|
04585-002CN6 |
|
China |
|
95 1 9320X |
|
25-May-1995 |
|
Pending |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||
|
|
|
|
|
|
|
|
|
|
|
04585-002EP5 |
|
Europe |
|
93 918139.2 |
|
29-Jun-1993 |
|
Pending |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||
|
|
|
|
|
|
|
|
|
|
|
04585-002EP6 |
|
Europe |
|
95922145.8 |
|
25-May-1995 |
|
Pending |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||
|
|
|
|
|
|
|
|
|
|
|
04585-002IE1 |
|
Ireland |
|
921062 |
|
03-Apr-1992 |
|
Pending |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||
|
|
|
|
|
|
|
|
|
|
|
04585-002MX6 |
|
Mexico |
|
965812 |
|
25-May-1995 |
|
Pending |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||
|
|
|
|
|
|
|
|
|
|
|
04585-002PH5 |
|
Philippines |
|
44157 |
|
03-Apr-1992 |
|
Pending |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||
|
|
|
|
|
|
|
|
|
|
|
04585-002008 |
|
United States |
|
08/470,339 |
|
06-Jun-1995 |
|
Pending |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||
|
|
|
|
|
|
|
|
|
|
|
04585-00200E |
|
United States |
|
08/469,549 |
|
06-Jun-1995 |
|
Pending |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||
|
|
|
|
|
|
|
|
|
|
|
04585-00200F |
|
United States |
|
08/471,833 |
|
06-Jun-1995 |
|
Pending |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||
|
|
|
|
|
|
|
|
|
|
|
04585-00200H |
|
United States |
|
08/472,065 |
|
06-Jun-1995 |
|
Pending |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||
|
|
|
|
|
|
|
|
|
|
|
04585-00200I |
|
United States |
|
08/734,665 |
|
22-Oct-1996 |
|
Pending |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
||||||||||
|
|
|
|
|
|
|
|
|
|
|
04585-00200M |
|
United States |
|
08/735,010 |
|
13-May-1999 |
|
Pending |
|
Andrew D.J. Goodearl et al. |
Title: GLIAL MITOGENIC FACTORS, THEIR PREPARATION AND USE |
3
4
5
6
Exhibit 10.23
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
LICENSE AGREEMENT
This License Agreement (the AGREEMENT) is entered into this 12th day of November, 2002 (the EFFECTIVE DATE), by and between CeNes Pharmaceuticals, plc, a corporation organized and existing under the laws of the United Kingdom and having a principal place of business at Compass House, Vision Park, Chivers Way, Histon, Cambridge CB4 9ZR, England (hereinafter CeNeS) and Acorda Therapeutics, Inc., a corporation organized and existing under the laws of the State of Delaware and having a principal place of business at 15 Skyline Drive, Hawthorne, NY 10532 (hereinafter Acorda or LICENSEE).
WHEREAS, CeNeS, by its acquisition of Cambridge NeuroScience, Inc., has exclusive rights under that certain license agreement, as amended, (the Harvard License) by and between Cambridge NeuroScience, Inc. and President and Fellows of Harvard College (Harvard), acting on its behalf and, pursuant to an inter-institutional agreement (the Inter-Institutional Agreement), acting on behalf of the Leland Stanford Junior College (STANFORD) pursuant to which Harvard licensed certain rights to Cambridge NeuroScience, Inc.;
WHEREAS, CeNeS and Acorda are parties to that certain license option agreement, as amended, pursuant to which CeNeS granted an option to Acorda to, among other things, obtain a sublicense of the rights granted by Harvard to Cambridge NeuroScience, Inc. pursuant and subject to the Harvard License (the LICENSE OPTION AGREEMENT)
WHEREAS, Acorda desires to exercise such option and to acquire a sublicense of such rights as set forth herein; and
WHEREAS, CeNeS desires to grant a sublicense of such rights as set forth herein.
NOW THEREFORE, in consideration of the foregoing premises and of other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereby agree as follows:
As used in this AGREEMENT, the terms below shall have the following meanings:
NET SALES also includes the fair market value of any non-cash consideration received by LICENSEE or SUBLICENSEES for the SALE, lease, or transfer of LICENSED PRODUCTS.
2
3
4
5
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
6
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
January 1, 2003 |
|
$ |
[**] |
|
|
|
|
|
|
January 1, 2004 |
|
$ |
[**] |
|
|
|
|
|
|
January 1, 2005 |
|
$ |
[**] |
|
|
|
|
|
|
January 1 of each additional year prior to the first to occur of (i) the termination date of this AGREEMENT; or (ii) expiration of the PATENT RIGHTS |
|
$ |
[**] |
|
7
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
For clarity, should a PROTEIN PRODUCT be abandoned by LICENSEE, its AFFILIATE or SUBLICENSEE for any reason following completion of any of milestones (b) through (e) but prior to completion of milestone (f), and LICENSEE commences development of a subsequent PROTEIN PRODUCT, then LICENSEE shall resume the milestone payments for such subsequent PROTEIN PRODUCT starting at the event subsequent to the event for which a milestone payment had already been paid. Each milestone payment shall be paid only once by LICENSEE.
8
Each such Royalty Report shall be certified as correct by an officer of LICENSEE to the best of such officers knowledge, and shall include a detailed listing of all deductions from royalties.
9
10
11
12
13
For purposes of this AGREEMENT, all such information and data which a party is obligated to retain in confidence shall be called Information. Any written information, materials or data relating to NRG-2 disclosed by one party to the other party pursuant to the LICENSE OPTION AGREEMENT and the Confidentiality Agreement entered into as of July 23, 2001 shall be deemed Information under this AGREEMENT.
Each party, its AFFILIATES or SUBLICENSEES may disclose Information to regulatory authorities to the extent that such disclosure is necessary for the prosecution and enforcement of patents, authorizations to conduct clinical trials or commercialization of LICENSED PRODUCTS, provided that such party is
14
otherwise entitled to engage in such activities under this AGREEMENT. Each party, its AFFILIATES or SUBLICENSEES may disclose Information to the government or a court of competent jurisdiction, provided that such disclosing party (a) provides the other party with adequate notice of the required disclosure, (b) cooperates with the other party s efforts to protect its Information with respect to such disclosure and (c) takes all reasonable measures requested by the other party to challenge or to modify the scope of such required disclosure. CeNeS may disclose Information to Harvard and Stanford to the extent such disclosure is required pursuant to CeNeS s obligations under the Harvard License.
15
16
17
18
If to Acorda:
Acorda Therapeutics, Inc.
15 Skyline Drive
Hawthorne, NY 10532
Attn: President and Chief Executive Officer
with a copy to:
Acorda Therapeutics, Inc.
15 Skyline Drive
Hawthorne, NY 10532
Attn. Harold Safferstein, Vice President, Business Development
If to CeNeS:
CeNeS Pharmaceuticals plc
Compass House
Vision Park
Chivers Way
Histon, Cambridge CB4 9ZR
England
Attn: Neil Clark, Chief Operating Officer and Finance Director
By such notice either party may change their address for future notices. Notices delivered in person shall be deemed given on the date delivered. Notices sent by fax shall be deemed given on the date faxed. Notices mailed shall be deemed given on the date postmarked on the envelope.
19
IN WITNESS WHEREOF, the parties hereto have caused this AGREEMENT to be executed by their duly authorized representatives.
CeNeS Pharmaceuticals PLC |
Acordia Therapeutics, Inc. |
||||||||
|
|
||||||||
|
|
||||||||
By: |
/s/ Neil Clark |
|
By: |
/s/ Harold T. Safferstein |
|
||||
|
|
|
|
|
|
||||
Print Name: |
Neil Clark |
|
Print Name: |
Harold T. Safferstein |
|
||||
|
|
|
|
|
|
||||
Title: |
Finance Director |
|
Title: |
VP Business Development |
|
||||
20
APPENDIX A
LAHIVE AND, COCKFIELD CASES
US Patent Application serial number 08/525,864 filed September 8,1995 entitled Cerebellum-Derived Growth Factors and Uses Related Thereto
PCT Patent Application serial number PCT/US96/14484 filed September 9,1996 entitled Cerebellum-Derived Growth Factors, and Uses Related Thereto,. designating Australia, Canada, EPO, Japan and South Korea
U.S. Patent Number 5,912,326
Cerebellum-Derived Growth Factors
Inventor: Han Chang
Filed September 8, 1995
Issued June 15, 1999
European Patent Application Number 96 93 2981.2
Cerebellum-Derived Growth Factors. and Uses Related Thereto
Filed September 9,1996
Canadian Patent Application Number 2,228,590
Cerebellum-Derived Growth Factors and Uses Related Thereto
Filed September 9,1996
Australian Patent Application Number 71563/96
Cerebellum-Derived Growth Factors and Uses Related Thereto
Filed September 9, 1996
Japanese Patent Application Serial Number
9-511448
Cerebellum-Derived Growth Factors and Uses Related Thereto
Filed September 9, 1996
South Korean Patent Application Serial Number
701775/98
Cerebellum-Derived Growth Factors and Uses. Related Thereto
Filed September 9,1996
CLARK & ELBING CASES
United States. Patent Application Serial Number
60/206,495
nrg-Z nucleic acid Molecules, polypeptides, and diagnostic and therapeutic
methods
Filed 23-May-2000
United States Patent Application Serial Number
09/864,675
nrg-2 nucleic acid molecules, polypeptides, and diagnostic and therapeutic
methods
Filed May 23.2001.
PCT Patent Application Serial Number US01/16896
nrg-2 nucleic add molecules, polypeptides, and diagnostic and therapeutic
methods
Filed May 23 2001.
21
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
APPENDIX B
The following. comprise BIOLOGICAL MATERIALS supplied by Stanford:
cerebellum-derived growth factor (CDGF) cDNA clones
- rat DCDGP cDNA 2b, 2d, 3
- human CDCF.cDNA clone h-nrg-2
expression construct and cell lines:
- pRc/CMV-2b; for, rat CDGF-beta
- CHO cells stably transfected with pRc/CMV2-b
22
Exhibit 10.24
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
LICENSE AGREEMENT
BETWEEN
ACORDA THERAPEUTICS, INC.
AND
THE MAYO FOUNDATION FOR
EDUCATION AND RESEARCH
Dated: September 8, 2000
TABLE OF CONTENTS
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OWNERSHIP; PATENTS; MARKETING EXCLUSIVITY; PATENT TERM EXTENSIONS |
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iii
LIST OF EXHIBITS
|
EXHIBIT A |
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|
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EXHIBIT B |
|
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EXHIBIT C |
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EXHIBIT D |
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EXHIBIT E |
iv
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this Agreement) is entered into as of September 8, 2000 (the Effective Date), by and between Acorda Therapeutics, Inc., a Delaware corporation, having offices at 15 Skyline Drive, Hawthorne, New York 10532, (ACORDA) and The Mayo Foundation for Medical Education and Research, a Minnesota charitable corporation located at 200 First Street SW, Rochester, Minnesota 55905 (MAYO).
PRELIMINARY STATEMENTS
A. ACORDA has sponsored two research programs under the direction of Dr. Moses Rodriguez and Dr. Larry Pease, entitled (1) Preclinical Studies of a Monoclonal Antibody Designed to Promote Central Nervous Repair, and (2) Molecular Characterization of Antibody-Induced Remyelination and Isolation of Human Counterparts, (each a Program and collectively, the Programs), pursuant to two Sponsored Research Agreements between MAYO and ACORDA, dated as of October 1, 1995 and March 15, 1998, respectively, (the Sponsored Research Agreements) which are attached hereto as Exhibit A . These Programs have related to, among other things, the therapeutic use of humanized and non-humanized antibodies for treatment of central nervous system conditions and disorders, including myelination or remyelination in conditions such as spinal cord injuries and multiple sclerosis.
B. MAYO is the owner of certain right, title and interest to technology made or otherwise developed in performance of the Programs including certain inventions, discoveries and patents described in the Sponsored Research Agreements.
C. MAYO has the right to grant licenses to this technology so that such technology may be utilized in the public interest, and is willing to grant a license thereunder to ACORDA.
D. ACORDA has options, pursuant to ACORDA\MAYO Option Agreements dated as of October 1, 1995 and March 15, 1998 (the Option Agreements), which are attached hereto as Exhibit B, to acquire an exclusive, worldwide license to such technology and is desirous of obtaining certain rights and licenses from MAYO relating to the aforementioned technology.
E. ACORDA wishes to exercise the options under both Option Agreements and ACORDA and MAYO now desire to provide for the license of all technology in all fields contemplated by the exercise of the options granted under both of the Option Agreements under one unified set of terms conditions, and for revised consideration, as provided under this Agreement, which shall be deemed to amend and supercede the provisions of the Option Agreements.
NOW THEREFORE, in consideration of the foregoing and of the mutual covenants contained in this Agreement, the Parties hereto agree to the provisions of the Preliminary Statements and as follows:
1. DEFINITIONS.
As used in this Agreement, the following terms will have the meanings set forth in this Section 1 unless the context dictates otherwise.
2
3
4
5
6
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
7
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
[**] of the first [**] of annual Net Sales; and
[**] of all annual Net Sales in excess of [**].
8
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
[**] of the first [**] of annual Net Sales;
[**] of annual Net Sales between [**] and [**];
[**] of annual Net Sales between [**] and [**]; and
[**] of annual Net Sales in excess of [**].
9
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
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6. OWNERSHIP; PATENTS; MARKETING EXCLUSIVI TY; PATENT TERM EXTENSIONS
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7. PUBLICATION; CONFIDENTIALITY.
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ACORDA shall, during the term of this Agreement, carry occurrence-based liability insurance with policy limits of at least THREE MILLION DOLLARS ($3,000,000). In addition, such policy shall name MAYO as an additional-named insured.
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If to ACORDA, to: |
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ACORDA THERAPEUTICS, INC. |
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15 Skyline Drive |
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Hawthorne, New York 10532 |
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Attention: President |
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Facsimile No.: (914)347-4560 |
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If to MAYO, to: |
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MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH |
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200 First Street, SW |
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Rochester, Minnesota 55905 |
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Attention: Office of Technology Commercialization, Mayo Medical Ventures |
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Facsimile No.: 507-284-5410 |
If delivered personally or by facsimile transmission, the date of delivery shall be deemed to be the date on which such notice or request was given. If sent by overnight express courier service, the date of delivery shall be deemed to be the next business day after such notice or request was deposited with such service. If sent by registered or certified mail, the date of delivery shall be deemed to be the third business day after such notice or request was deposited with the U.S. Postal Service.
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* * *
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IN WITNESS WHEREOF, each of the Parties has caused this License Agreement to be signed by its duly authorized representative as of the date first written above.
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ACORDA THERAPEUTICS |
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By: |
/s/ Ron Cohen |
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Name: Ron Cohen |
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Title: President and CEO |
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MAYO FOUNDATION FOR
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/s/ Rick F. Colvin |
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Name: Rick F. Colvin |
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Title: Assistant Treasurer |
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Exhibit C
Remvelination Monoclonal Antibody Cases
PCT/U.S. Serial No. |
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Title of Application |
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Date of Filing |
US#5,591,629 |
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Monoclonal Antibodies Which Promote Central Nervous System Remyelination |
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4/29/94 |
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[*] |
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[*] |
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4/27/95 |
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[*] |
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[*] |
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8/8/96 |
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[*] |
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1/7/97 |
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5/28/99 |
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5/30/00 |
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[*] |
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5/10/00 |
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5/30/00 |
EXHIBIT D
MANDATORY MEDIATION AND BINDING ARBITRATION
1. NOTICE OF DISPUTE . Except to the extent otherwise expressly provided in Sections 5.3 and 5.4 of this Agreement, any dispute related to this Agreement between the Parties, including its formation, performance, or Termination, which cannot be resolved by the Parties themselves within thirty (30) clays of written notice by one Party to the other of the existence of a dispute, may be referred by either of the parties to mandatory mediation and binding arbitration under the terms of this Exhibit. The Parties intend the mediation/arbitration procedure described in this Exhibit to substitute in all cases for litigation related to any such dispute, subject only to part 7, below, and this agreement to submit all such disputes to mandatory mediation and binding arbitration is irrevocable.
2. LIMITATION PERIOD . No demand for mediation/arbitration may be made regarding any claim more than one hundred eighty (180) days after written notice by one Party to the other of the existence of a dispute, regardless of any otherwise applicable statute of limitations.
3. MEDIATOR/ARBITRATOR . If the Parties cannot agree upon a single mediator/arbitrator within fourteen (14) days after written demand by either of them for mediation/arbitration, then a single mediator/arbitrator shall be chosen by the American Arbitration Association office in New York City, New York, within thirty (30) additional days after the fourteen (14) day period. The mediator/arbitrator shall be generally experienced in the legal and technical matters related to the dispute.
4. MEDIATION . Within thirty (30) days of the appointment of the mediator/arbitrator, the Parties must attend a mediation session at which the mediator/arbitrator personally shall attempt to guide the Parties to a settlement. Each Party may be represented by counsel at the mediation, but each Party must attend through an officer having authority to agree to a settlement at the mediation. The mediation session shall occur in New York City, New York, and shall extend no longer than a single day. Statements or offers made at the mediation session shall not be admissible in any later arbitration hearing.
5. ARBITRATION . If such mediation has not resulted in a mutually-executed settlement agreement (or withdrawal of claim) within five (5) business days after the date of mediation, then the Parties shall proceed to arbitration as described below. Such arbitration, which the Parties intend to be final and to substitute for litigation, shall occur in New York City, New York, and the arbitration results maybe entered as a final judgment in any court with jurisdiction. The decision of the arbitrator shall be final and binding upon the Parties both as to law and fact.
(a) Initial Disclosures. Within twenty-one (21) days after the date of mediation, the Parties shall exchange written disclosures listing with reasonable specificity: (i) all exhibits expected to be used by the Party at arbitration, and complete copies of such exhibits, (ii) all witnesses expected to be called by the Party at arbitration, and (iii) the substance of the testimony of each witness. Copies of such disclosures shall be sent to the arbitrator. No exhibit or witness may be called if the same does not appear on such disclosure, and
no witness may testify as to matters not described in such disclosure, except for rebuttal testimony as may be permitted by the arbitrator.
(b) Discovery Period. Within fourteen (14) days after exchange of the disclosure notices, the Parties shall make specific discovery requests to the arbitrator, and within an additional fourteen (14) days the arbitrator shall issue to both parties a joint discovery order. The discovery period preceding the arbitration hearing shall not exceed sixty (60) days from the issuance of the discovery order by the arbitrator.
(c) Scope of Discovery. Discovery shall be limited to that ordered by the arbitrator as being reasonable and necessary, and in no case shall exceed the deposition of two (2) witnesses for each Party, and/or the exchange of more than a total of twenty-five (25) specific and non-compound interrogatories by each party, and/or two specific requests by each Party for the production of documents considered by the arbitrator to be reasonably relevant and not unduly burdensome.
(d) Hearing. The arbitration hearing, which shall be confidential to the parties and not open to the public, shall not exceed two (2) separate days, and shall be completed within thirty (30) days of the close of discovery. The arbitrator may admit any testimony or other evidence which the arbitrator decides is reasonably relevant to the issues of the arbitration, but excluding statements or offers made by either Party at the mediation session.
(e) Final Decision. The arbitrator shall issue a final written decision no later than sixty (60) days following the end of the arbitration hearing, stating findings as to law and fact. The decision shall be confidential to the Parties. The arbitrator shall be limited to determining and ordering the payment of actual and direct damages if any, and may order the payment of indirect, special, incidental, or consequential damages only where bad faith has been shown and/or to the extent required to fulfill any obligations under Article 8 of the Agreement. The arbitrator shall not order the payment of punitive or exemplary damages in any case.
6. COSTS AND FEES . Both Parties shall be responsible for their own costs and fees (including attorneys fees), and shall divide common costs and fees equally; however, if the arbitrator specifically finds bad faith on the Part of either Party, then the arbitrator may order a different division of costs and fees.
7. EQUITABLE RELIEF . Nothing in this Exhibit prohibits either Party from seeking equitable relief to protect its rights to the extent that irreparable harm may occur and damages would not be a sufficient remedy, except that neither Party shall seek to enjoin mediation/arbitration as described in this Exhibit.
( a) Specific Performance. Among the equitable remedies that a Party may seek under this part 7, either Party may petition a court for specific performance of the terms of this Exhibit, including following the failure of either Party without good cause to adhere to the time limits set out in this Exhibit. A Party securing an order for specific performance
2
under this part 7(a) is entitled to recover costs and reasonable attorneys fees in connection with such petition for specific performance and any related hearings.
8. SURVIVAL . The rights and obligations of the Parties described in this Exhibit survive the Termination, expiration, non-renewal, or rescission of this Agreement.
9. GOVERNING RULES AND LAW . To the extent not inconsistent with the terms of this Exhibit, the mediation and arbitration are governed by the rules of the American Arbitration Association, the Minnesota Arbitration Act, and the Federal Arbitration Act (9 U.S.C s. 1 et seq.).
3
Exhibit A
to
License Agreement between
Acorda Therapeutics, Inc. and the
Mayo Foundation for Education and Research,
dated September 8, 2000
APPENDIX A
SPONSORED RESEARCH AGREEMENT
Effective as of October 1,1995, MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH, a Minnesota charitable corporation (MAYO), with Moses Rodriguez, M.D. as principal investigator (INVESTIGATOR) and, Acorda Therapeutics, Inc. a Delaware corporation (ACORDA) agree as follows:
Article 1. Project Summary
1.1 MAYO will undertake a research project described in the protocol attached here as Exhibit A (PROTOCOL). Summary data about the project is set forth as follows:
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TITLE: Preclinical Studies of a Monoclonal Antibody Designed to Promote Central Nervous Repair |
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PURPOSE: Determine suitability of monoclonal antibody SCH 94.32 in promoting CNS remyelination in animal models of spinal cord injury and multiple sclerosis |
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START DATE: October 1, 1995 |
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(d) |
PROJECTED COMPLETION DATE: September 30, 1998 |
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FUNDING AMOUNT: $292,000 |
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PAYMENT PLAN: Quarterly payments in advance, except that final quarter payment in each year is payable on receipt of a written Annual Report Year 1 - $63,000; Year 2 - $110,000; Year 3 - $118,000 |
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(g) |
CHECKS PAYABLE TO: |
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Mayo Foundation for Medical Education and Research |
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(h) |
CHECKS MAILED TO: |
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Office of Technology Transfer Mayo Medical Ventures 200 First Street S.W. Rochester, Minnesota 55905 Attn: Susan L. Stoddard, Ph.D. |
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(i) |
MAYO ADMINISTRATIVE CONTACT: |
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Susan L. Stoddard, Ph.D. Mayo Medical Ventures 200 First Street S.W. Rochester, Minnesota 55905 507-284-8878 |
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(j) |
ACORDA ADMINISTRATIVE CONTACT: |
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Ron Cohen, M.D. Acorda Therapeutics, Inc. 1213 Park Avenue New York, NY 10128 212-876-2522 |
1.2 Anything contained in the PROTOCOL which is in conflict with anything in this Agreement is superseded by this Agreement.
1
Article 2. Proprietary Data Provided To Mayo By Acorda
2.1 ACORDA may provide MAYO and INVESTIGATOR with proprietary data (DATA) relevant to the work under this Agreement. MAYOs and INVESTIGATORS acceptance and use of DATA shall be subject to the following:
a) DATA must be marked or designated in writing as proprietary to ACORDA by marking it CONFIDENTIAL, or words of similar import. If oral, visual, or other non-written manner of disclosure of otherwise undisclosed confidential information is made, such information shall be entitled to protection if identified as confidential at the time of initial disclosure and if a written notice with a summary of such disclosures is delivered to the receiving party within thirty (30) days of such disclosure. Any markings, stamps, or legends identifying confidential information shall not impose any obligations on either party inconsistent with this agreement. Any copies of the information made by the receiving party shall reproduce the confidential markings and any other legends contained on such information.
b) MAYO and INVESTIGATOR retain the right to refuse to accept any DATA which they do not consider to be essential to the completion of the project or which they believe to be improperly designated or for any reason.
c) Where MAYO and INVESTIGATOR accept such DATA, they agree to exercise their best efforts not to use the DATA for any purpose except the conduct of the PROTOCOL and not to publish or otherwise reveal the DATA to others outside Mayo without the permission of the ACORDA, unless the DATA has already been published or disclosed publicly by third parties or is required to be disclosed by order of a court of law.
Article 3. Inventions, Discoveries And Patents
3.1 All original data and records of the work completed under this Agreement shall remain the property of MAYO.
3.2 MAYO shall own all of its inventions, discoveries and other developments, whether or not patentable arising out of research carried out under the provisions of this Agreement. ACORDA shall own all of its inventions, discoveries and other developments, whether or not patentable arising out of research carried out under the provisions of this Agreement. Inventions or discoveries made jointly by both MAYO and ACORDA shall be jointly owned by both parties and, if patent applications are filed, patents shall be applied for on behalf of both parties.
Article 4. Publication
4.1 MAYO and INVESTIGATOR reserve the right to publish the results of work completed under this Agreement. Prior review of the proposed publication by ACORDA will be provided, but in the interest of free exchange of scientific information, MAYO and INVESTIGATOR may publish after the expiration of forty-five (45) days following mailing of the proposed publication to ACORDA. Publication of the results will not include DATA as defined in Article 2 without the permission of ACORDA. At ACORDAs request, MAYO will delay submission, disclosure, or publication for an additional sixty (60) days in order to enable the preparation and filing of a patent application on any such patentable subject matter.
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Article 5. Use Of Name
5.1 ACORDA and MAYO shall not use expressly or by implication, any trademark, trade name, or any contraction, abbreviation, simulation, or adaptation thereof of the other party, or the name of any of other partys staff in any news, publicity release, policy recommendation, advertising or any commercial communication without the express written approval of the other party.
Article 6. Indemnification And Negation Of Warranties
6.1 ACORDA agrees to defend, indemnify and hold harmless MAYO and INVESTIGATOR against any and all costs, damages, expenses, including attorneys fees, arising from any claims, damages and liabilities asserted by third parties arising from ACORDAs use of the results of the work performed under this Agreement.
MAYO agrees to defend, indemnify and hold harmless ACORDA against any and all costs, damages, expenses, including attorneys fees, arising from any claims, damages and liabilities asserted by third parties arising from MAYOs conduct or use of the results of the work performed under this Agreement.
As used in the preceding parts of this paragraph, MAYO includes its Trustees, Officers, Agents, and Employees and ACORDA includes any of its Affiliates. An Affiliate of ACORDA shall mean any corporation or other business entity controlled by, controlling, or under common control with ACORDA. For this purpose control means direct or indirect beneficial ownership of at least fifty (50%) percent of the voting stock, or at least fifty (50%) percent interest in the income of such corporation or other business
6.2 MAYO makes no representations or warranties, expressed or implied, regarding its performance under this Agreement, including but not limited to, the marketability, use or fitness for any particular purpose of the research results developed under this work, or that such results do not infringe upon any third party property rights. Further, MAYO shall not be liable for special, consequential, or incidental damages, and MAYOs sole liability for damages hereunder shall be a sum equal to the amount paid by ACORDA to MAYO under this Agreement.
Article 7. Fiscal Management
7.1 MAYO shall maintain complete and accurate accounting records in accordance with accepted accounting practices. These records shall be available for inspection, review and audit at reasonable times by ACORDA, or its duly authorized representative, at ACORDAs expense, for three (3) years following the end of the calendar year in which such costs are incurred.
7.2 MAYO shall retain title to equipment and all other items purchased with funds provided by ACORDA.
7.3 Mayo shall not utilize funds from any other commercial entity to conduct the PROTOCOL.
Article 8. Termination
8.1 If for any reason INVESTIGATOR becomes unavailable to direct the performance of the work under this Agreement, MAYO shall notify ACORDA. If a mutually acceptable successor is not identified, this Agreement may be terminated immediately by either party and ACORDA shall have no further obligation to pay MAYO further funds for the conduct of the PROTOCOL, except as set forth in Section 8.3.
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8.2 Following nine (9) months after the effective date of the Option Agreement, ACORDA shall have the right to terminate this agreement at will within ninety (90) days notice; provided, ACORDA shall be obligated to pay MAYO the salary and benefits of one research technician until the second anniversary of the effective date of the Option Agreement, unless MAYO receives extramural contract or grant funds to support such technician. Should ACORDA terminate this Agreement under this Section 8.2, MAYO agrees to best efforts to find other sources of funding for the technical salary.
8.3 If this Agreement is terminated, ACORDA shall pay for all direct costs incurred, up to and including the effective date of termination, and for all noncancellable obligations made before receipt of notice of termination, even though they may extend beyond such termination date. Any unexpended funds paid by ACORDA and held by MAYO after satisfying the obligations set forth in this paragraph will be returned to ACORDA.
8.4 ACORDA and MAYO maintain the right to terminate this Agreement if a material breach is committed by the other party, if this breach is not cured within thirty (30) days after written notice to the breaching party. If this Agreement is so terminated under this Section 8.4, the terminating party shall maintain no continuing financial obligation to the breaching parry.
Article 9. General
9.1 This Agreement may be amended only by the written agreement of the parties.
9.2 This Agreement may not be assigned by MAYO or ACORDA without the prior written consent of the other.
9.3 The captions and headings used in this Agreement are for convenience and reference only and are not a part of this Agreement.
9.4 All notices shall be in writing and shall be effective when mailed. Notices should be sent to the respective administrative contacts set forth in paragraph 1.1 of this Agreement.
9.5 This Agreement and its effects are subject to and shall be construed and enforced in accordance with the laws of the State of Minnesota.
9.6 There is one addenda to this Sponsored Research Agreement:
a) Exhibit A: Research Protocol
MAYO
FOUNDATION FOR MEDICAL
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ACORDA THERAPEUTICS, INC. |
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Assist. Treas. |
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President & CEO |
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Oct. 11, 1995 |
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10/06/95 |
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/s/ Moses Rodriguez |
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Investigator |
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4
EXHIBIT A to SPONSORED RESEARCH AGREEMENT
Protocol
PROPOSAL FOR RON COHEN - ACORDA
TITLE : Pre-clinical Studies of a Monoclonal Antibody Designed to Promote Central Nervous System Repair
INVESTIGATOR: Moses Rodriguez, M.D.
INTRODUCTION AND SCIENTIFIC RATIONALE :
Our laboratory has been interested in developing novel strategies to promote central nervous system (CNS) remyelination. Even though there is experimental evidence in animals and humans that remyelination does occur in the CNS, at present there are no pharmacological approaches to promote CNS remyelination. We have used an experimental model induced by a virus to investigate ways to promote CNS remyelination in the spinal cord. Susceptible strains of mice infected intracerebrally with Theilers murine encephalomyelitis virus (TMEV) develop chronic progressive immuna-mediated CNS demyelinating disease which is similar to multiple sclerosis (MS). Our previous reports indicated that polyclonal immunoglobulins from mice immunized with homogenized spinal cord promoted CNS remyelination when given to SJL/J mice chronically infected for 3 to 6 months with TMEV. To explore further the mechanisms of CNS remyelination, we made a panel of monoclonal antibodies (mAbs) derived from splenocytes of SJL/J mice injected with homogenized spinal cord. These mAbs were screened for function rather than for specific antigens. We identified two monoclonal IgM autoantibodies, designated SCH 94.03 and SCH 94.32, which promoted four-fold increase in CNS remyelination compared to isotype IgM kappa controls when given to chronically infected SJL/J mice. The results of these experiments are in press in the Journal of Neuroscience. CNS remyelination was detected morphologically by the presence of abnormally thin myelin sheaths relative to axon diameter. In these experiments, as little as 10 µg of antibody promoted CNS remyelination. We assessed whether morphologic remyelination was correlated with clinical signs of disease improvement. With each treatment injection, animals were assessed clinically. We correlated the change in clinical score with the percentage of lesion area showing remyelination. Using data from all treatment groups, there was a moderate but significant correlation with the percentage of lesion area showing remyelination with less progression of clinical disease. A few animals treated with mAb actually improved clinically. However, the majority of the animals showed less progressive disease than animals treated with isotype control antibody.
We are in the process in determining the antigen specificity for SCH 94.03 and SCH 94.32. To characterize initially the antigens recognized by mAbs, we immunostained various cell lines from glial, neural, fibroblast, epithelial and lymphoid origins. Thus far, the mAbs strain structural internal antigens of all cell lines tested. Only cells or primary cell lines of oligodendroglial lineage stain on the surface with these mAbs. Surface staining has been confirmed by flow cytometry. Surface labelling has also been detected on live rat, mouse, and human oligodendrocytes.
1
We have evidence that mAbs SCH 94.03 and SCH 94.32 are identical and are natural autoantibodies. This hypothesis was tested using a series of strategies including immunocytochemistry, Western blotting, enzyme-linked immunosorbent assays, and Ig variable region sequencing. Natural autoantibodies are typically encoded by germline Ig genes, with few if any V region somatic mutations. Therefore, we cloned and sequenced both the Ig V L and V H regions from SCH94.03. The SCH94.03 V L region was encoded by a combination of V k 10 and J k l gene segments. In the coding region, the SCH94.03 V k gene segment showed 99.6% nucleotide identity with a germline V k 10 gene, with only one silent nucleotide difference at the V gene segment 3 end, at the V-J junction (codon 95). Similarly, the SCH94.03 J k gene segment showed 97.4% nucleotide identity with the germline J k l gene, with one silent nucleotide change at the J gene segment 3 end, at the J-C k junction (codon 108). As both of these changes were in junction regions, and the genomic nucleotide immediately upstream from the coding regions of both J k l and C k gene segments is a C, these changes may have resulted from imprecise joining during Ig gene rearrangement, rather than from somatic mutation. We concluded that the V L region of SCH94.03 was encoded by germline Ig genes.
The V H region of SCH94.03 was also encoded by germline Ig genes. The SCH94.03 V K region was encoded by a combination of V23, DFL16.1, and J K 2 gene segments. The SC H 94.03 V H gene segment showed 100% nucleotide identity with the germline V23 gene, a member of the V K J558 family. The SCH94.03 J H gene segment showed 97.8% nucleotide identity with the germline J H 2 gene, with a T to A change in the most 5 nucleotide of the J H segment, at the D-J H junction (codon 100C). This resulted in a change from tyrosine to asparagine. The SCH94.03 D gene segment contained 15 contiguous nucleotides derived from the germline DFL16.1 gene. There were 8 nucleotides in the V H -D junction, and 1 in the D-J H junction which did not correspond to any known germline V H , D, or J H region genes, and probably represented non-coded (N) nucleotides inserted by the enzyme terminal deoxynucleotide transferase (TdT) during V-D-J recombination. All of these nucleotides were either G or C, consistent with the preferential insertion of G nucleotides by TdT. Therefore, similar to the SCH94.03 V L region, all of the nucleotide changes in the SCH94.03 V H region were in junctional regions, and may have been produced during Ig gene rearrangement by a variety of mechanisms, including imprecise joining, N-nucleotides, or P-nucleotide additions, rather than somatic mutations. We concluded from these data that the V H region of SCH94.03 was encoded by germline Ig genes, with no definitive somatic mutations.
Even though the preliminary antigen reactivity results suggest that SCH 94.03 is a natural autoantibody, this does not represent a mechanism of how SCH 94.03 stimulates remyelination in the CNS. However, it does suggest an important physiological function of natural autoantibodies. We propose that autoantibodies that are produced during normal physiology or as a response to tissue damage may participate in promoting repair of damaged tissue. This active participation may be to facilitate removal of damaged tissue and mask autoantigens, therefore, preventing vigorous pathogenic immune responses, Natural auto antibodies may modulate immune responses which actually result in tissue destruction. Alternatively, this mAb could directly bind to the surface of oligodendrocytes and stimulate proliferation differentiation of these cells. Either hypothesis could result in functional improvement.
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Specific Goals:
(1) To determine whether treatment with mAb SCH 94.32 promotes functional repair or improvement in conduction in an established animal model of acute spinal cord trauma.
(2) To determine whether treatment with mAb SCH 94.32 promotes CNS remyelination and improvement in neurological function in an established model of chronic spinal cord injury.
(3) To determine whether treatment with mAb SCH 94.32 alters disease in established models of autoimmunity such as collagen-induced arthritis (model of rheumatoid arthritis), experimental autoimmune encephalomyelitis (model of multiple sclerosis), experimental myasthenia gravis, and NOD diabetic mouse (spontaneous model of diabetes mellitus). This specific aim would test directly the hypothesis that the antibodies may be working through an immunological mechanism.
(4) To develop strategies to humanize mAb SCH 94.32.
(5) To complete toxicity and safety studies required by the FDA to bring mAb SCH94.32 to clinical trials.
General Approach to Accomplish Specific Aims:
The experiments involving the acute and chronic spinal cord injury models (Specific Aims 1 and 2) should be performed in collaboration with an established laboratory in this field. The laboratory of Dr. Weiss Young comes readily to mind. Titration and route of administration experiments would need to be done. We would provide mAbs, as well as control antibodies purified in a similar manner, so there would be no experimental bias. Rats or mice would be studied morphologically, clinically, behaviorally, and electrophysiologically at various timepoints following acute or chronic spinal cord injury. MAbs would be given prior to trauma in one group of experiments, but also 4 to 6 hours after trauma in an other group of experiments to simulate the clinical situation. Details of the experimental protocol would be finalized during a meeting between the two labs. The potential role of this antibody in downregulating the immune response may be beneficial in preventing secondary injury following trauma. Experiments would be designed to examine the extent of inflammatory infiltrates using immunocytochemistry and FACS of infiltrating cells within areas of spinal cord injury. These techniques are established in our laboratory.
The use of mAbs in other established models of autoimmunity (Specific Aim 3) would test the possibility that the mAbs are working through immunological mechanisms. Dr. Chella Davids laboratory at the Mayo Clinic has expensive expertise in the field of collagen induced arthritis. We have already established collaborative arrangements with Dr. Ram Sriram at Vanderbilt University who is an expert in experimental autoimmune encephalomyelitis. Dr. Vanda Lennon at Mayo Clinic has expertise in experimental autoimmune myasthenia. Dr. Ed Lambert, a world-class electrophysiologist, could help with experiments to determine whether treatment with mAb has an effect on miniature end-plate potentials in myasthenia gravis.
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Based on our preliminary data, we should consider humanizing the mAbs. Because we have identified the germline sequences, this could be accomplished readily. We have not done this previously in our own laboratory. However, there are a number of Mayo investigators with molecular biology expertise who have experience with this technology. Alternatively, it may be possible to collaborate with a pharmaceutical company to carry out this technical endeavor.
Last, it is important to determine from the FDA what are the toxicity and safety requirements before we could bring mAb SCH94.32 to clinical trials (Specific aim 5). Having a meeting with the FDA would be appropriate. At that point a detailed strategy could be outlined to bring this promising drug to clinical trials. Thus far we have not observed any untoward side effects with the mAb. Treatment of normal animals with mAb has not resulted in longterm deficits. In addition, we have done preliminary safety data in THEV-infected mice of resistant haplotypes. These mice have not converted to susceptibility following treatment with the mAb. It is possible that further studies need to be performed in other species (dogs, cats, monkeys, etc.). we have the technical expertise at Mayo to perform many of these experiments. At present we do not have a monkey facility at Mayo, even though these kinds of experiments have been done previously. It may be easier to perform these experiments in collaboration with a pharmaceutical company with this expertise.
SUMMARY :
We are very enthusiastic about the possibility of taking mAb SCH94.32 to clinical trials. The experiments outlined in this proposal could be accomplished within three or four years depending upon the collaborative arrangements. Specific Aims 1 and 2 (acute and chronic spinal cord injury) should be started immediately. This has direct relevance to the longterm plans of Acordn. This should be feasible to complete in approximately two years. Specific Aim 3 (testing of therapeutic efficacy in other established models of autoimmunity) may have a very important impact into the marketing of this mAb. If the mAb has an effect immunologically as well as directly on the CCS, it may be applicable to other established autoimmune diseases. We expect that these experiments could be accomplished in two to three years. Specific aim 4 (humanizing mAb) is dependent upon whether the help of a pharmaceutical company is requested. Specific aim 5 is dependent upon the requirements from the FDA. Therefore it is impossible to give an exact estimate of when this could be accomplished.
RELEVANT BIBLIOGRAPHY FROM OUR LABORATORY :
1. Rodriguez M . Lennon VA: Immunoglobulins Promote Remyelination the Central Nervous System. Ann. Neurol. 27:12-17, 1990.
2. Rodrigues M . Pierce ML, Thiemann R.L: Immunoglobulins stimulate CSS Remyelination: Electron Microscopic and Morphometric Analysis of Proliferating Calls. Lab. Invest. 64:358-370, 1991.
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3. Patick AK, Thiemann RL, OBrien PC, Rodriguez M : Persistence of Theilers Virus Infection Following Promotion of CNS Remyelination. J. Neuropath. Exp. Neurol. 50:523-537, 1991.
4. Rodriguez M . Lindsley M: Immunosuppression Promotes Central Nervous System Remyelination in Chronic Virus-Induced Demyelinating Disease. Neurology 42:348-357, 1992.
5. van Engelen BGM, Hommes OR, Pinckers A, Cruysberg JRM, Barkhof F, Rodriguez M : Improved Vision in Non-Recovering Optic Neuritis after Intravenous Immunoglobulin Possibly due to Remyelination. Ann. Neurol. 32:834-835, 1992.
6. Prayoonwiwat N, Rodriguez M : The Potential for Oligodendrocyte Proliferation during Demyelinating Disease. J. Neuropath. Exp. Neurol. 52:55-63, 1993.
7. Miller DJ, Sanborn KS, Katzmann JA, Rodriguez M : Monoclonal Antibody- Mediated Nervous System Repair in a Viral Model of Multiple Sclerosis. J. Neuroscience, in press.
8. Rodriguez M . Miller DJ: Immune Promotion of Central Nervous System Remyelination. Progress in Brain Research, in press.
9. van Engelen BGM, Miller DJ, Pavelko KD, Hommes OR, Rodriguez M : Promotion of Remyelination by Polyclonal Immunoglobulin in Theilers Virus-induced Demyelination and in Multiple Sclerosis, J. Neurol. Neurosurg, Psych., in press.
10. Noseworthy JH, OBrien PC, van Engelen BGM, Rodriguez M : Intravenous Immunoglobulin Therapy in Multiple Sclerosis. Progress from the Theilers Virus Model to a Randomized, Double-blinded, Placebo-controlled Clinical Trial, J. Neurol. Neurosurg, Psych., in press.
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EXHIBIT A
ACORDA/MAYO
SPONSORED RESEARCH AGREEMENT
Effective as of March 15, 1998, Mayo Foundation, a Minnesota charitable corporation (MAYO), with Larry Pease, Ph.D., and Moses Rodriguez, M.D., as principal Investigators (INVESTIGATORS) and, Acorda Therapeutics, Inc. a Delaware corporation (ACORDA) agree as follows:
Article 1. Project summary
1.1 MAYO will undertake a research project described in the Statement of Work and Budget attached here as Exhibit C (PROJECT). Summary data about the project is set forth as follows:
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(a) |
TITLE: |
Molecular Characterization of Antibody-Induced Remyelination and isolation of Human Counterparts. |
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PURPOSE: |
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(i) To Investigate the mechanisms underlying antibody-induced remyelination and to identify human equivalents of the biologically active mouse monoclonal antibodies that are known to induce remyelination. Understanding the mechanism for the basis of antibody-induced remyelination in the mouse is important for determining the biological requirements for mimicking this process in humans and could lead to the development of more effective modifications of the current approach for inducing myelin repair. |
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(ii) Because antibodies themselves may be the target of immune attack, the process could be improved by isolating less immunogenic, human counterparts of the currently known, biologically active mouse antibodies. The ability of human antibodies to induce remyelination in mouse models of demyelinating disease will be the basis for selecting human antibodies for further development for clinical trials. |
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(c) |
START DATE: The Effective Date of this Agreement. |
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(d) |
PROJECTED COMPLETION DATE: One year from Start Date. |
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FUNDING AMOUNT: $233,431.00 |
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PAYMENT PLAN: Quarterly payments in advance, except that final quarter payment in each year is payable on receipt of a written Annual Report. Year 1 - $150,000.00 Year 2 - $40,897.00 Year 3 - $42,534.00. |
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( g) |
CHECKS PAYABLE TO: |
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Mayo Foundation for Medical Education and Research |
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(h) |
CHECKS MAILED TO: |
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Office of Technology Transfer |
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Mayo Medical Ventures |
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200 First Street S.W. |
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Rochester, Minnesota 55905 |
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Attn: Susan L. Stoddard; Ph.D. |
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(i) |
MAYO ADMINISTRATIVE CONTACT: |
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Susan L. Stoddard, Ph.D. Mayo Medical Ventures 200 First Street S.W. Rochester, Minnesota 55905 507-284-8878 |
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(j) |
ACORDA ADMINISTRATIVE CONTACT: |
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Ron Cohen, M.D. President & CEO Acorda Therapeutics, Inc. 145 West 58th Street, Suite 8J New York, NY 10019 212-376-7553 |
1.2 Anything contained in the PROJECT which is in conflict with anything In this greement is superseded by this Agreement.
Article 2. Proprietary Data Provided To Mayo By Acorda
2.1 AGORDA may provide MAYO and INVESTIGATORS with proprietary data (DATA) relevant to the work under this Agreement. MAYOs and INVESTIGATORS acceptance and use of DATA shall be subject to the following:
a) DATA must be marked or designated in writing as propriatary to ACORDA by marking it CONFIDENTIAL, or words of similar import. If oral, visual, or other non-written manner of disclosure of otherwise undisclosed confidential information is made, such information shall be entitled to protection if Identified as confidential at the time of initial disclosure and if a written notice with a summary of such disclosures is delivered to the receiving party within thirty (30) days of such disclosure. Any markings, stamps, or legends identifying confidential Information shall not impose any obligations on either party inconsistent with this agreement. Any copies of the information made by the receiving party shall reproduce the confidential markings and any other legends contained on such information.
b ) MAYO and INVESTIGATORS retain the right to refuse to accept any DATA which they do not consider to be essential to the completion of the project or which they believe to be improperly designated or for any reason.
c) Where MAYO and INVESTIGATORS accept such DATA, they agree to exercise their best efforts not to use the DATA for any purpose except the conduct of the PROJECT and not to publish or otherwise reveal the DATA to others outside Mayo without the permission of ACORDA, unless the DATA has already been published or disclosed publicly by third parties or is required to be disclosed by order of a court of law.
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Article 3. Term
3.1 The term of this Agreement shall commence on the Effective Date of the Agreement as set forth above and continue for a period of one (1) year. In the event that milestones are met in such year and, in ACORDAs opinion, the PROJECT continues to be of commercial Interest, the term of this Agreement shall be extended for a second and third year except that support of one (1) person shall be for the entire three year period in the amounts described in Article 4 and Exhibit C.
3.2 Except as provided in Section 3.1, any extension of this Agreement must be in writing upon terms mutually agreeable to the parties hereto.
Article 4. Payment
4.1 ACORDA agrees to pay $150,000.00 for services to be provided in the first year of this Agreement in accordance with the following payment schedule:
(a) $37,500.00 on execution of this Agreement,
(b) $37,500.00 on the later of either (i) the three (3) month anniversary of the effective date of this Agreement, or (ii) the three month anniversary of the date the work on the PROJECT began, and
(c) $37,500.00 on (i) the three (3) month anniversary of the date of payment by ACORDA under (b), and (ii) on each subsequent three (3) month anniversary thereafter until the sum of all the payments made by ACORDA pursuant to this Section 3.1 equals $150,000.00
ACORDA agrees to pay a minimum of $40,897,00 for services to be provided in the second year of this Agreement in accordance with the following payment schedule:
(d) $10,224,25 on the later of either (i) the one (1) year anniversary of the effective date of the Agreement, or (ii) the three (3) months anniversary of the date of the final payment by ACORDA under (c) above; and
(e) $10,224.25 on (i) the three (3) month anniversary of the date of payment by ACORDA under (d), and (ii) on each subsequent three (3) month anniversary thereof until the sum of all payments made by Sponsor pursuant to this Section 3.1 in the second year of this agreement equals $40,897.00
In the event that milestones are met in year one (1) and, in ACORDAs opinion, the PROJECT continues to be of commercial interest, ACORDA agrees to pay;
(f) Additional payments for supplies and equipment estimated at $99,000.00 in year two with the final budget to be determined by mutual written agreement of both parties and the agreed amount paid quarterly.
ACORDA agrees to pay a minimum of $42,534.00 for services to be provided In the third year of this Agreement in accordance with the following payment schedule:
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(g) $10,633.50 on the later of either (i) the two (2) year anniversary of the effective date of the Agreement, or (ii) the three (3) months anniversary of the date of the final payment by ACORDA under (e) above, and
(h) $10,633.50 on (i) the three (3) month anniversary of the date of payment by ACORDA under (g), and (ii) on each subsequent three (3) month anniversary thereof until the sum of all payments made by Sponsor pursuant to this Section 3.1 in the third year of this agreement equals $42,534.00
In the event that milestones are met in year two (2) and, in ACORDAs opinion, the PROJECT continues to be of commercial interest, ACORDA agrees to pay:
(i) Additional payments for supplies and equipment estimated at S110,000.00 in year three with the final budget to be determined by mutual written agreement of both parties and the agreed amount paid quarterly.
4.2 MAYO shall not spend any amounts on the conduct of PROJECT except amounts provided by ACORDA hereunder with prior written agreement by both parties. MAYO shall not expend any amount on capital equipment in excess of $5,000 without the prior written consent of ACORDA.
4.3 The amounts set forth in Section 4.1 shall be ACORDAs full support of the research and shall cover all direct and indirect costs (including, without limitation, overhead) of conducting such research.
Article 5. Reports
5.1 Every six (6) months following the beginning date of the PROJECT, MAYO shall provide ACORDA with an Interim written report describing activities, progress and results to date of the PROJECT. Within ninety (90) days after completion of the PROJECT by MAYO, of earlier termination of this Agreement, MAYO shall provide a final written report to ACORDA describing the services performed and such other information or data as may be specified in Exhibit B. MAYO shall also, at ACORDAs option, meet with ACORDA to discuss the PROJECT and the Interim and final reports.
5.2 ACORDA shall have the right to use such reports and data for any purposes, subject to Sections 7.2 and 10.1 below.
Article 6. Insurance
6.1 MAYO shall at its expense provide the necessary Workers Compensation and Employers Liability Insurance to meet statutory liability limits of State Of Minnesota for the employees of MAYO involved in the PROJECT.
Article 7. Liability
7.1 MAYO shall not be responsible or liable for any injuries or losses which may result from the implementation or use by ACORDA or its designees of the results from the PROJECT or research data generated by MAYO.
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7.2 ACORDA agrees to indemnify, defend and hold harmless MAYO, Its trustees, officers, agents and employees (the MAYO Indemnitees) with respect to any expense, claim, liability, loss, damage, or costs (including attorneys fees) in connection with or in any way arising out of the use by ACORDA of the data or results from the Project; provided, however, that ACORDA shall have not such obligation to the extent that any such claim, liability, loss damage or costs results from the negligence or willful misconduct of a MAYO Indemnitee.
7.3 MAYO agrees to indemnify, defend and hold harmless ACORDA, its trustees, officers, agents and employees (ACORDA Indemnitees) with respect to any expense, claim, liability, loss, damage, or costs (including attorneys fees) in connection with or in any way arising out of the conduct of the PROJECT at the MAYO; provided, however, that MAYO shall have no such obligation to the extent that any such claim, liability, loss, damage or costs result from the negligence or willful misconduct of a ACORDA Indemnitee.
Article 8. Inventions, Discoveries And Patents
8.1 All original data and records of the work completed under this Agreement shall remain the property of MAYO.
8.2 MAYO shall own all rights and title to its Inventions. For purposes of this Agreement, Inventions shall mean Inventions, discoveries and other intellectual property conceived, reduced to practice, made or otherwise developed by MAYO employees or agents, whether or not patentable, during the term of this Agreement as it may be extended, relating to the PROJECT. Rights held by MAYO in any inventions, including without limitation rights in end to patent applications and patents which may be obtained thereon, shall be deemed to be within the term Technology as used in the License Agreement term sheet attached hereto and shall be subject to the license granted ACORDA therein. ACORDA shall own all of its inventions, discoveries and other developments, whether or not patentable, arising out of research carried out under the provisions of this Agreement. Inventions or discoveries made jointly by both MAYO and ACORDA shall be jointly owned by both parties and, if patent applications are filed, patents shall be applied for on behalf of both parties. MAYOs interest in any inventions, whether or not patentable, arising out of research carried out under the provisions of this Agreement, shall be subject to the Option Agreement.
Article 9. Publication
9.1 MAYO and INVESTIGATORS reserve the right to publish or otherwise publicly disclose the results of work completed under this Agreement. MAYO agrees to submit to ACORDA any proposed publication or presentation for review sixty (60) days prior to submission. Acorda shall, within forty-five (45) days after receipt, advise in writing if there is any proprietary or patentable information which should not be disclosed at the present time. Publication of the results will not include DATA as defined in Article 2 without the express written permission of ACORDA. MAYO will acknowledge ACORDAs financial support of PROJECT in all publications unless ACORDA requests otherwise.
9.2 At ACORDAs request, MAYO will delay submission, disclosure, or publication for an additional sixty (60) days or longer by mutual written agreement of both parties in order to enable the preparation and filing of a patent application on any such patentable subject matter.
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9.3 MAYO acknowledges that it may be necessary for INVESTIGATORS to disclose information which ACORDA considers proprietary or confidential in order to perform the PROJECT. If ACORDA considers any such information confidential, it shall be clearly marked CONFIDENTIAL INFORMATION and sent by ACORDA in writing only to the INVESTIGATORS or orally disclosed to INVESTIGATORS and reduced to writing by ACORDA within thirty (30) days of disclosure. Except as expressly necessary for the performance of the PROJECT. MAYO and INVESTIGATORS shall maintain such information as confidential, not disclose it to others, limit access to it to those employees with a need to know, and take such action as shall be reasonably necessary to ensure that its employees will not disclose it to others.
Article 10. Use Of Name
10.1 ACORDA and MAYO shall not use expressly or by implication, any trademark, trade name, or any contraction, abbreviation, simulation, or adaptation thereof of the other party, or the name of any of other partys staff in any news, publicity release, policy recommendation, advertising or any commercial communication without the express written approval of the other party; provided, however, once a public announcement has been approved, further approvals need not be obtained for further announcements which are not materially different from an earlier approved announcement.
Article 11. Indemnification And Negation Of Warranties
11.1 ACORDA agrees to defend, indemnify and hold harmless MAYO and INVESTIGATORS against any and all costs, damages, expenses, including attorneys fees, arising from any claims, damages and liabilities asserted by third parties arising from ACORDAs use of the results of the work performed under this Agreement.
MAYO agrees to defend, indemnify and hold harmless ACORDA against any and all costs, damages, expenses, including attorneys fees, arising from any claims, damages and liabilities asserted by third parties arising from MAYOs conduct or use of the results of the work performed under this Agreement.
As used in the preceding parts of this paragraph, MAYO includes its Trustees, Officers, Agents, and Employees and ACORDA includes any of its Affiliates. An Affiliate of ACORDA shall mean any corporation or other business entity controlled by, controlling, or under common control with ACORDA. For this purpose control means direct or indirect beneficial ownership of at least fifty (50%) percent of the voting stock, or at least fifty (50%), percent interest in the income of such corporation or other business
11.2 MAYO makes no representations or warranties, expressed or implied, regarding its performance under this Agreement, including but not limited to, the marketability, use or fitness for any particular purpose of the research results developed under this work, or that such results do not infringe upon any third party property rights. Further, MAYO shall not be liable for special, consequential, or incidental damages, and MAYOs sole liability for damages hereunder shall be a sum equal to the amount paid by ACORDA to MAYO under this Agreement.
Article 12. Fiscal Management
12.1 MAYO costs shall follow the proposed budget as contained in Exhibit C. MAYO shall maintain complete and accurate accounting records in accordance with accepted accounting practices. These records shall be available for inspection, review and audit at reasonable times
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by ACORDA, or its duly authorized representative, at ACORDAs expense, for three (3) years following the end of the calendar year in which such costs are incurred.
12.2 MAYO shall retain title to equipment and all other items purchased with funds provided by ACORDA, MAYO shall not expend any amount on capital equipment in excess of $5,000 without the prior written consent of ACORDA.
12.3 Mayo shall not utilize funds from any other commercial entity to conduct the PROJECT.
Article 13. Termination
13.1 If for any reason INVESTIGATORS becomes unavailable to direct the performance of the work under this Agreement, MAYO shall notify ACORDA. If a mutually acceptable successor is not identified within forty-five (45) days, this Agreement may be terminated immediately by either party and ACORDA shall have no further obligation to pay MAYO further funds for the conduct of the PROJECT, except as set forth in Section 13.2 and 13.3.
13.2 Following nine (9) months after the effective date of the Option Agreement, ACORDA shall have the right to terminate this agreement at will within ninety (90) days notice; provided, ACORDA shall be obligated to pay MAYO the salary and benefits of one research technician until the third anniversary of the effective date of the Option Agreement, unless MAYO receives extramural contract or grant funds to support such technician. Should ACORDA terminate this Agreement under this Section 13.2, MAYO agrees to use best efforts to find other sources of funding for the technical salary.
13.3 If this Agreement is terminated, ACORDA shall pay for all direct costs incurred, up to and including the effective date of termination, and for all noncancellable obligations made before receipt of notice of termination, even though they may extend beyond such termination date. Any unexpended funds paid by ACORDA and held by MAYO after satisfying the obligations set forth in this paragraph will be returned to ACORDA.
13.4 ACORDA and MAYO maintain the right to terminate this Agreement if a material breach is committed by the other party, if this breach is not cured within thirty (30) days after written notice to the breaching party. If this Agreement is so terminated under this Section 13.4, the terminating party shall maintain no continuing financial obligation to the breaching party.
Article 14. General
14.1 This Agreement may be amended only by the written agreement of the parties.
14.2 This Agreement may not be assigned by MAYO or ACORDA without the prior written consent of the other.
14.3 The captions and headings used in this Agreement are for convenience and reference only and are not a part of this Agreement.
14.4 All notices shall be in writing and shall be effective when mailed. Notices should be sent to the respective administrative contacts set forth in paragraph 1.1 of this Agreement.
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14.5 This Agreement and its effects are subject to end shall be construed and enforced in accordance with the laws of the State of Minnesota.
14.6 There is one addenda to this Sponsored Research Agreement:
a) Exhibit B: Statement of Work and Budget
14.7 Both parties agree that execution of this Sponsored Research Agreement may be effected by the receipt of facsimile signature pages
MAYO FOUNDATION |
ACORDA THERAPEUTICS, INC. |
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Signed: |
/s/ John H. Herrell |
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Signed: |
/s/ Ron Cohen |
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Name: |
John H. Herrell |
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Name: |
Ron Cohen, M.D. |
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Title: |
Vice President |
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Title: |
President & CEO |
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Date: |
March 24, 1998 |
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Date: |
3/20/98 |
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INVESTIGATORS |
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Signed: |
/s/ Moses Rodriguez |
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Signed: |
Larry R. Pease |
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Name: |
Moses Rodriguez |
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Name: |
Larry R. Pease |
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Title: |
M.D. |
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Title: |
Ph.D. |
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Date: |
March 25, 1998 |
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Date: |
3/25/98 |
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EXHIBIT B
ACORDA/MAYO
STATEMENT OF WORK AND BUDGET
1. Statement of work
(a) |
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TITLE: |
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Molecular Characterization of Antibody-Induced Remyelination and Isolation of Human Counterparts. |
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(b) |
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PURPOSE |
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(i) To investigate the mechanisms underlying antibody-induced remyelination and to identify human equivalents of the biologically active mouse monoclonal antibodies that are known to induce remyelination. Understanding the mechanism for the basis of antibody-induced remyelination in the mouse is important for determining the biological requirements for mimicking this process in humans and could lead to the development of more effective modifications of the current approach for inducing myelin repair. |
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(ii) Because antibodies themselves may be the target of immune attack, the process could be improved by isolating less immunogenic, human counterparts of the currently known, biologically active mouse antibodies. The ability of human antibodies to induce remyelination in mouse models demyelinating disease will be the basis for selecting human antibodies for further development for clinical trials. |
2. Milestones & Budget; Year One (1)
A) First six (6) months :
1. Hire research fellow end technician.
2. Screen EBV transformed cell lines available for IgM secreting cells (culturing of first 11 lines initiated, Eliza assay being developed to screen antibody).
3. Screen tissue culture supernatants from IgM+ lines for binding activity using rat oligodendrocytes.
4. Subclone EBV lines that are making IgM antibody, with emphasis on lines with demonstrable oligodendrocyte-binding activity.
5. Generate cassette expression system for manipulation of antibody gens structures and for expression of antibodies gene in transfected hybridoma cells.
6. Construct chimeric 94.03/human IgM constant region antibody to evaluate the ability of the human Fo portion of IgM to Induce remyellnation in mice.
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7. Establish parameters of transfectoma technology in house.
8. Initiate biochemical analysis of 94.03 antibody. Prepare monomeric IgM, evaluate in vivo half life comparisons between pentameric and monomeric forms.
B) Second six (6) months - items carried over (A) above :
1. Completed.
2,3. Continue screening. Note: As of 1/98 have approximately 60 lines to evaluate: timing will depend on results as program progresses.
4. In the event that no lines produce demonstrable antibodies, we will proceed to subclone cells from 10 lines to evaluate the possibility that clones of desired phenotype exist but cannot be visualized in the pool. Lines from normal individuals and five from individuals who have been diagnosed with MS will be evaluated by cloning. It will be necessary to develop an assay that will enable us to estimate the complexity of the line. The most straight forward approach would be to generate Southern blot of the cloned cells using the most C proximal J region as a probe. Different restriction enzyme digestion patterns should be distinguish clones from each other depending on which V and which J was being used.
5. Generation of cassette system for manipulating Ig sequences should be completed in the first six months.
6. Generate and clone transfectoma of mouse/human chimeric antibody. Produce ascites and prepare antibody for testing in animal model.
7. Parameters for generating transfectomas should be established in first six months.
8. Assess the ability of monomeric antibody to induce remyellnation. If the i n vivo half life is low, we may need to explore alternate route of antibody administration such as local administration.
9. Generate by site-directed mutagenesis a mouse IgM variant of 94.03 that cannot fix complement. Establish transfectoma that expresses this variant.
10. At the end of the first year, we will evaluate progress in each of the aims and establish milestones for year two (2).
Budget: Year One.
(1) |
Personnel (Including benefits) |
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$ |
71,042.00 |
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(2) |
Supplies |
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$ |
40,280.00 |
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(3) |
Other Expenses - mouse husbandry |
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$ |
13,678.00 |
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(4) |
Overhead (20%) |
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$ |
25,000.00 |
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TOTAL |
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$ |
150,000.00 |
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3. Milestones & Budget: Year Two (2)
A) Milestones to be determined
Minimum Budget: Year Two.
(1) |
Personnel (including benefits) |
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$ |
34,081.00 |
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(2) |
Supplies |
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$ |
0.00 |
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(3) |
Other Expenses - mouse husbandry |
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$ |
0.00 |
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(4) |
Overhead (min. est. @ 20%) |
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$ |
6,816.00 |
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TOTAL |
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$ |
40,897.00 |
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4. Milestones & Budget: Year Three (3)
A) Milestones to be determined
Minimum Budget: Year Three.
(1) |
Personnel (including benefits) |
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$ |
35,445.00 |
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(2) |
Supplies |
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$ |
0.00 |
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(3) |
Other Expenses - mouse husbandry |
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$ |
0.00 |
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(4) |
Overhead (min. est. @ 20%) |
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$ |
7,089.00 |
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TOTAL |
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$ |
42,534.00 |
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AMENDMENT No. 1
TO
SPONSORED RESEARCH AGREEMENT
BETWEEN
Effective as of 28 September 1999, the Sponsored Research Agreement dated March 15, 1998 between Mayo Foundation for Medical Education and Research (MAYO) and Acorda Therapeutics, Inc. (ACORDA) is hereby amended under the following terms:
Section 4.1(j) is inserted.
During the second year of the Agreement, ACORDA agrees to pay FIFTY DOLLARS (US $50,000.00) in excess of the amounts described in sections 4.1(d), 4.1(e) and 4.1(f) hereto, such funds to be directed specifically to the costs related to animal care and maintenance at MAYO.
The terms of this Amendment No. 1 supersede any conflicting or inconsistent terms in the Sponsored Research Agreement. All other provisions of the original Sponsored Research Agreement effective March 15, 1998 remain in full force and effect.
AMENDMENT TO
SPONSORED RESEARCH AGREEMENTS
BETWEEN
MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH
AND
ACORDA THERAPEUTICS, INC.
DATED JANUARY 2, 2001
Reference is made to the Sponsored Research Agreements between the parties dated October 1, 1995 and March 15, 1998. The research program attached hereto as Exhibit A shall be deemed additional research under these Sponsored Research Agreements. The parties agree that all results of this research shall be deemed to be included under the License Agreement between Mayo Foundation for Medical Education and Research and Acorda Therapeutics, Inc., dated September 9, 2000, and shall be treated for all purposes as Licensed Technology as defined in the License Agreement.
The new funded research program contemplated by this Amendment shall commence as of March 15, 2001 and will terminate on March 14, 2002, unless extended by mutual written agreement signed by both parties.
During the research period, ACORDA agrees to pay two hundred seventy seven thousand and two hundred dollars (US $277,200.00) payable in quarterly payments of sixty-nine thousand, three hundred dollars (US $69,300.00) each.
All other provisions of the License Agreement and the Sponsored Research Agreements, as previously amended, shall remain in full force and effect.
VIA FEDERAL EXPRESS
November 17, 2003
MAYO FOUNDATION FOR MEDICAL
EDUCATION AND RESEARCH
C/O Susan Stoddard, Ph.D.
Technology Licensing Manager
Office of Technology Commercialization
Mayo Medical Ventures
200 First Street SW
Rochester, Minnesota 55905
RE: Agreement between Acorda Therapeutics, Inc. and the Mayo Foundation for Education and Research
Dear Susan:
Reference is made to a certain License Agreement (the Agreement) dated September 8, 2000 by and between Acorda Therapeutics, Inc. and The Mayo Foundation for Education and Research.
The agreement is amended as follows:
Acorda and Mayo entered into a License Agreement dated September 8, 2000 (the License Agreement) wherein Licensed Technology, as defined therein, was developed in connection with two Mayo research programs previously sponsored by Acorda and referred to therein, as Programs (respectively entitled Preclinical Studies of Monoclonal Antibody Designed to Promote Central Nervous Repair and Molecular Characterization of Antibody-Induced Remyelination and Isolation of Human Counterparts).
Acorda and Mayo wish to sponsor and conduct additional research pursuant to the attached research plan and to include the results of this new research within the meaning of Licensed Technology under the License Agreement.
Accordingly, the parties agree that the attached research plan shall be attached to the License Agreement as an additional part of Exhibit A, that it shall be considered an additional Program within the meaning of the License Agreement, and that for all purposes under the License Agreement the term Program(s) shall be deemed to include the two Programs originally referenced in the License Agreement, the attached research plan, and any other future research which the parties may agree in writing to incorporate into Exhibit A of the License Agreement by amendment.
Notwithstanding anything contained in the original License Agreement to the contrary, the parties agree that with respect to any new intellectual property conceived or first reduced to practice as result of the new research conducted under the attached research plan, the definitions of Licensed Technology, Licensed Patents, Inventions and Know-How under the License Agreement shall only be interpreted to include intellectual property conceived or first reduced to practice in
15 SKYLINE DRIVE |
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PHONE: (914) 347-4300 |
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E-MAIL: ACORDA@ACORDA.COM |
HAWTHORNE, NY 10532 |
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FAX: (914) 347-4560 |
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WEBSITE: WWW.ACORDA.COM |
the course of or arising from the conduct of such research and for a period of two years thereafter, and not to any improvements, modifications, derivatives of such new intellectual property that may be conceived or first reduced to practice by Mayo more than two years after the conclusion of such research.
The attached research plan identifies all Mayo personnel who will conduct research proposed under such plan and the parties agree to identify in advance all Mayo personnel who will conduct research under any future Program, as well.
Additionally, for the avoidance of doubt in the interpretation of the License Agreement, the parties each hereby acknowledge and confirm that the two Option Agreements between the parties dated October 1, 1995 and March 15, 1998 were exercised and shall each be deemed to have been terminated as of the effective date of the License Agreement.
This Letter Agreement amends the Agreement only to the extent specified herein and shall not constitute an amendment or modification of any other provision of the License Agreement. From and after the date hereof, all references to the Agreement shall be references to the amended Agreement hereby.
The Agreement amended hereby, constitutes the full and complete agreement among the parties hereto and supersedes any and all other agreements and understandings, whether oral or written, between the Parties.
If the foregoing accurately sets forth our agreement, please so indicate by executing this letter agreement and the enclosed copy in the spaces provided and returning one original to Tippy Lucarelli.
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Very truly yours, |
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/s/ Harold Safferstein |
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Harold Safferstein, Ph.D., J.D. |
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Vice President, Business Development |
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AGREED TO AND ACCEPTED: |
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/s/ Rick F. Colvin |
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By: |
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Rick F. Colvin |
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Title: |
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Assistant Treasurer |
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Date: |
11/18/03 |
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Executive Summary
Pre-clinical Development of Remyelination Promoting Antibodies
September 2003
Investigators
Magdalena Hofer, Ph.D. |
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Principal Investigator |
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Acorda Therapeutics |
Allan J. Bieber, Ph.D. |
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Principal Investigator |
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Mayo Clinic |
Moses Rodriguez, M.D. |
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Co-Principal Investigator |
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Mayo Clinic |
Larry R. Pease, Ph.D. |
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Investigator |
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Mayo Clinic |
Arthur Warrington, Ph.D. |
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Investigator |
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Mayo Clinic |
Charles Howe, Ph.D. |
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Investigator |
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Mayo Clinic |
The long-term goal of this agreement is to continue to study and develop monoclonal antibodies that promote remyelination of central system nerve fibers and to bring these antibodies to clinical trials.
We have demonstrated that certain human antibodies can promote CNS remyelination and have identified human monoclonal antibodies (sHIgM22 and sHIgM46) which strongly and consistently enhance remyelination in the Theilers virus and lysolecithin models of demyelination in mice. We have constructed vectors that direct the expression of recombinant forms of these antibodies (RcHIgM22 and RcHIgM46) when introduced into cultured cells, making the large-scale production of these antibodies possible. Recently, the expression vectors have been modified to allow for the expression of both IgM (22M-5,6 and 46M-6) and IgG4 (22G4-9 and 46G4-8,9) forms of both antibodies under good manufacturing practice (GMP) conditions.
This agreement, Pre-clinical Development of Remyelination Promoting Antibodies, will focus on research in four Research Areas: 1) in vivo efficacy testing and dose determination for the four candidate antibodies produced under GMP conditions, in the Theilers virus model of demyelinating disease in mice, 2) use of cDNA microarrays to assess gene expression changes that take place in response to antibody treatment under a variety of conditions and in different cell types, 3) biochemical characterization of the cellular signaling pathways that are induced by antibody binding, and 4) characterization of the functionally relevant cell surface antigens that are bound by remyelination promoting antibodies. Specific details for experiments addressing each of these areas are presented in the attached document. The Mayo MS Research group will make a good-faith effort to deliver data for the experiments enumerated for Research Areas 1, 2 and 3, and will supply material for use in the antigen characterization studies in Research Area 4. Acorda will make a good-faith effort to indentify the most relevant antigens with regard to antibody enhanced remyelination (Research Area 4). Acorda will supply funding for the Mayo research, as indicated in the attached budget. The current funding agreement will be for 1 year. The experimental and financial scope of future agreements will be contingent upon progress towards completion of the current agreement.
Pre-clinical Development of Remyelination Promoting Antibodies
Budget 2003/2004
Proposed total $ to Mayo from Acorda (including entire STTR directs) |
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$ |
400,000 |
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Total $ from STTR directs |
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$ |
105,000 |
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STTR directs spent in 2002 (estimated) |
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$ |
(10,000 |
) |
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(STTR indirects are not considered here) |
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$ |
95,000 |
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Funds from Acorda: |
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$ |
295,000 |
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Direct |
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$ |
204,000 |
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Indirect (44.5%) |
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$ |
91,000 |
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Total direct $ to lab |
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= |
$ |
299,000 |
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Total $ (direct+indirect) to Mayo |
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= |
$ |
390,000 |
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Personnel: (estimates only)
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Budgeted
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Budgeted
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Budgeted
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Budgeted
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Total |
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Allan
Bieber, Ph.D.
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40 |
% |
40 |
% |
$ |
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$ |
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$ |
22,000 |
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Moses Rodriguez,
M.D.
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5 |
% |
5 |
% |
$ |
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$ |
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$ |
9,552 |
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Larry R. Pease,
Ph.D.
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5 |
% |
5 |
% |
$ |
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$ |
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$ |
9,552 |
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Art Warrington,
Ph.D.
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20 |
% |
20 |
% |
$ |
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$ |
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$ |
11,000 |
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Charles Howe,
Ph.D.
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20 |
% |
20 |
% |
$ |
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$ |
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$ |
11,000 |
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Total Personnel |
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$ |
63,104 |
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Supply Expenses:
2002/2003 Pre-clinical animal testing: |
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Animals - 250 SJL/J mice, 6 weeks old females @ $16.90/mouse (Jackson Labs). |
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$ |
4,225 |
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Animal Maintenance - Based on 100 cages @ $0.56/cage/day for 365 days. |
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$ |
20,440 |
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Tissue preparation materials - araldite, osmium |
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$ |
15,000 |
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Tissue and slide preparation - 10 slides/animals, 170 animals, @ $10.00/slide |
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$ |
17,000 |
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Technician processing time - fixation, dissection, embedding |
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$ |
5,000 |
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Supplies: 2002/03 in vivo testing |
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$ |
61,665 |
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2003/2004 Pre-clinical animal testing: |
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Animals - 250 SJL/J mice, 6 weeks old females @ $16.90/mouse (Jackson Labs). |
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$ |
4,225 |
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Animal Maintenance - Based on 100 cages @ $0.56/cage/day for 365 days. |
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$ |
20,440 |
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Tissue preparation materials - araldite, osmium |
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$ |
15,000 |
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Tissue and slide preparation - 10 slides/animal, 160 animals, @ $10.00/slide |
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$ |
16,000 |
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Technician processing time - fixation, dissection, embedding |
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$ |
4,500 |
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Supplies: 2003/04 in vivo testing |
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$ |
60,165 |
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2
Supply Expenses: Antibody-induced signaling. |
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Microarrays - Affymetrix microarrays and array processing |
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$ |
50,000 |
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Animals - Purchase and short-term housing for 50 Sprague-Dawley rats provided as untimed pregnancies for the generation of primary oligodendrocyte cultures. |
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$ |
4,000 |
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Tissue Culture - Culture of primary oligodendrocytes derived from mixed glial cultures. |
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Culture of CG4 cells under defined media conditions. Cost includes growth factors, hormones, media, supplements, serum, and plasticware. |
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$ |
12,000 |
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Antibodies - anti-phosphotyrosine (4G10), anti-phospho-JNK, anti-phospho-IkB and NFkB, anti-phospho-ERK 1/2 anti-phospho-p38, anti-phospho-Akt, anti-EGFR, anti-PDGFR, anti-IGFR, anti-FGFR, anti-src family members, anti-caspases, secondaries and immunoprecipitation materials |
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$ |
10,000 |
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Pharmacological Agents - JNK inhibitors, NFkB inhibitors, TNFa and Fasm, B-MCD and Filipin. |
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$ |
4,000 |
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Radiation - 35 SO 4 and 3 H lipid derivatives |
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$ |
4,000 |
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PAGE Materials - Basic materials for 1 and 2-D PAGE |
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$ |
2,500 |
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TLC Materials - Basic Materials for 2-D TLC |
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Cell Fractionation Materials - cost includes plasticware and fractionation chemicals (e.g. OptiPrep) |
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$ |
2,500 |
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Supplies: Ab-induced signaling |
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$ |
91,500 |
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Supply Expenses: Antigen characterization. |
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Animals - |
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Purchase and short-term housing for 50 rats provided as untimed pregnancies for the generation of primary glial cultures. |
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$ |
3,000 |
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Purchase and short-term housing for 200 SJL mice for the generation of primary glial cultures. |
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$ |
3,500 |
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Tissue Culture - primary culture of rat, mouse, human glia, rat neurons, PC12 cells |
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$ |
12,000 |
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Enzymes and antibodies - carbohydrate specific enzymes, anti-chondroitin sulfate, anti-myelin basic protein, anti-phophotyrosine |
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$ |
4,000 |
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Supplies: Ag characterization |
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$ |
22,500 |
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Total personnel |
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$ |
63,104 |
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Total supplies |
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$ |
235,830 |
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Total DIRECT |
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$ |
298,934 |
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Total INDIRECT @ 44.5% |
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$ |
91,000 |
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Total cost |
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$ |
389,934 |
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3
Research Area 1: In vivo Antibody Treatment Experiments
Experiments 1 & 2 were completes in 2002/2003. These experiments determined the in vivo dose titration for remyelination in response to Rc22 treatment, examined the effect of co-treatment with methyl prednisolone and Rc22, and examined the effect pf co-treatment with Rc22 and Rc46.
Expt. 1 Rc22 Dosing; Rc22 + MePrednisolone 70 mice
Rc22 at:
500 µg
125 µg
50 µg
5 µg
PBS
MePr
MePr + Rc22, 500 µg
Expt. 2 Rc22 Dosing (repeat); Rc22 + MePrednisolone (repeat); Dbl;. Ab treatment 100 mice
Rc22 at:
500 µg
50 µg
5 µg
500 ng
50 ng
PBS
MePr
MePr + Rc22, 500 µg
Rc46, 500 µg
Rc46 + Rc22 250 µg
Experiments 3 & 4 will be completed in 2003/2004. Experiment 3 will determined the in vivo efficacy of the IgM and IgG4 forms of Lym22 and Lym46, with regard to promotion of remyelination. A best candidate will be selected based on the results of Expt. 3 and Expt. 4 will determine the in vivo dose titration for remyelination in response to treatment with these (this) antibodies.
Expt. 3 IgMs vs. IgG4s 80 mice
Rc22 (all at 500 µg)
22M-5,6
22G4-9
46G4-8,9
46M-6
Kappa IgG4
human IgM
Acorda buffer
Expt. 4 IgMs vs. IgG4s: Repeat and Dosing 80 mice
Rc22, 500 µg
Best candidates at:
500 µg
50 µg
5 µg
500 ng
50 ng
Control Ab, 500 µg
Buffer
4
Research Area 2: Microarray Analysis
Experiment 1 will examine the effect of treatment of rat mixed primary glia with the IgM and IgG forms of Lym22 and Lym46. Gene expression data will be compared to our previous microarray experiments using Mayo Rc22, O4, and other antibodies. Experiment 2 will determine the dose response for the effect of best candidate antibodies on gene expression in MPG.
Expt. 1 IgMs vs. IgG4s (on rat MPGs)
Rc22 (all at 10 ug/ml)
22M-5,6
22G4-9
46G4-8,9
46M-6
kappa IgG4
human IgM
Buffer
Expt. 2 IgMs vs. IgG4s: Repeat and Dosing (on rat MPGs)
Rc22 (10 ug/ml)
Best candidates at:
10 ug/ml
500 ng/ml
50 ng/ml
10 ng/ml
Buffer
Our previous experiments suggest that treatment with remyelination promoting antibodies may have direct and distinct effects on gene expression in a wide variety of cells. Experiment 3 will test best candidate antibodies for their direct effect on gene expression in oligodendrocytes, astrocytes, macrophages, brain infiltrating lymphocytes and neurons.
Expt. 3 Best candidate effects on specific rat cell types (Oligos, astrocytes, macrophages, BILs, neurons)
Best candidate and dose (5 cell types)
Ab negative control (5 cell types)
Experiment 4 will determine whether the binding of antibody to the surface of oligodendrocytes correlates directly with observed effects on gene transcription. CGT mutant mice produce no sulfatide, the putative O4 antigen. We will isolate glia from these mice and test the gene expression responses of these cells to O4, Rc22 and other antibodies. Glia from normal mice will serve as controls.
Expt. 4 O4 signaling in mouse CGT MPGs
Rc22, 10 ug/ml on B6
O4, 10 ug/ml on B6
s39, 10 ug/ml on B6
PBS on B6
Rc22, 10 ug/ml on CGT
O4, 10 ug/ml on CGT
s39, 10 ug/ml on CGT
PBS on CGT
Experiment 5 is designed to demonstrate the relevance of the microarray data from rodent cells by repeating the basic antibody treatment experiment using a best candidate antibody and human mixed primary glia.
Expt. 5 Ab signaling in human MPGs
Rc22 (or best candidate), 10 ug/ml
O4, 10 ug/ml
s39, 10 ug/ml
PBS
5
Our previous data demonstrates significant effects of antibody treatment on CNS gene expression in SJL mice that are chronically infected with TMEV, Experiment 6 will repeat these experiments and will examine the dose response of the observed changes.
Expt. 6 In vivo treatment of chronic SJL mice with antibody dosing
Rc22 (or best candidate) at:
500 µg
50 µg
10 µ g
O4 at:
500 µ g
50 µ g
10 µ g
human IgM, 500 µg
PBS
Research Area 3: Antibody-induced Signaling Experiments
Hypothesis: Antibody-mediated enhancement of remyelination is the result of specific antibody-induced changes in the local architecture of the plasma membrane of glial cells that trigger specific second messenger systems and engage downstream signaling cascades. These signals result in transcriptional and translational events related to increased survival, proliferation, and differentiation of oligodendrocytes and oligodendrocyte precursors within and near demyelinating lesions. We will conduct experiments to identify antibody-induced signaling, cascades that are relevant to the induction of transcriptional changes involved in oligodendrocyte survival, proliferation, and differentiation.
Expt. 1 Identification of immediate second messenger signals triggered by antibody-induced plasma membrane reorganization.
Our preliminary data indicate that remyelination-promoting antibodies induce an immediate increase in intracellular calcium levels in astrocyte-like cells and a delayed calcium influx in oligodendrocyte-like cells. The immediate rise in calcium concentration is sensitive to perturbations of the PLCy signaling cascade, while the delayed calcium influx is dependent upon mobilization of extracellular calcium through plasma membrane CNQX-sensitive AMPA-type glutamate receptors. However, the precise locus and mode of activation of either calcium increase is undefined. Using immunoaffinity purification, we will prepare purified cultures of oligodendrocytes captured along a spectrum of developmental and differentiative stages. These purified and defined cell populations will then be subjected to ratiometrc fluorescent analysis of intracellular calcium concentration to determine the type of calcium signal induced by treatment with antibody. Using specific pharmacological agents we will determine whether the delayed calcium influx is the result of AMPA receptor agonism (e.g. autocrine or paracrine release of glutamate), desensitization (conformational change or alleviation of receptor antagonism), or capacitative calcium influx (calcium release activated calcium influx).
Expt. 2 Identification of downstream signaling cascades engaged by remyelination-promoting antibodies.
Isotope-coded affinity tag (ICAT) analysis is a sophisticated method for measuring differential protein expression in cultured cells. We propose to use the ICAT method to analyze changes in protein expression following treatment of oligodendroglia with remyelination promoting antibodies. We specifically propose to analyze the following domains: lipid rafts and AMPA receptor-enriched domains from oligodendrocytcs, and spinal cord demyelinated lesions induced by lysolecithin injection.
Two-dimensional gel electrophoresis (2-DGE) analysis coupled to western blotting with phosphorylation-state specific antibodies is also a useful tool for analysis of global signaling responses and identification of uncharacterized signaling molecules. We propose to use this discovery technique to identify potential signaling cascades involved in the transmission of antibody-induced responses from the plasma membrane to the nucleus.
6
Expt. 3 Characterization of antibody-induced survival, proliferation, and differentiation signals.
Preliminary evidence suggests that remyelination-promoting antibodies function, at least in part, by protecting oligodendroglia from cell death. We propose to clarify the nature of this protection and probe its physiological relevance. We will model macrophage- and/or lymphocyte-mediated killing in vitro by challenging oligodendroglia with H 2 O 2 TNF a 1 or FasL in the presence or absence of antibody. Cell death will be measured by MTT [3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide] assay, and death related signaling will be assessed by examination of changes in JNK, NFKB, Akt, and caspase-3 activity.
Remyelination-promoting antibodies may also exert effects on oligodendrocyte proliferation. We propose to measure this effect by treating oligodendroglia with antibodies in the presence of BrdU or 3 H-thymidine. BrdU incorporation will be assessed by imnunostaining, while 3 H-thymidine incorporation will be assessed by scintillation counting of cell lysates. Likewise, remyelination-promoting antibodies may exert a differentiative effect on oligodendrocyte precursors, pushing them to mature into myelin-producing cells. To test this effect, we propose to characterize the expression levels of myelin basic protein, proteolipid protein, and myelin associated glycoprotein in oligodendroglia cultured in the presence of remyelination-promoting antibodies.
Based on our hypothesis that remyelination-promoting antibodies specifically reorganize plasma membrane microdomains to initiate biologically relevant signals, we will determine whether disruption of lipid raft organization, either pharmacologically via B-MCD and filipin, or synthetically via cholesterol deprivation, will alter antibody-induced effects on oligodendroglial survival, proliferation, and differentiation. Likewise, based on the knowledge gained in the other proposed experiments, we will disrupt identified signal transduction cascades and measure the effect on cell survival, proliferation, and differentiation, For example, if signaling through Erk l/2 is identified as a relevant pathway, we will block O4-induced signaling with PD98059 (MEK inhibitor) or with the MTP TAT -MEK1 13 peptide inhibitor (Erk1/2 inhibitor). Similarly, if PKA signaling is identified above, we will attempt to block antibody-mediated effects on proliferation and survival using SQ22536 (adenylate cyclase inhibitor). H89 (PKA inhibitor), or Rp-cAMPs triethylamine (PKA inhibitor). We intend to take advantage of the availability of robust and specific pharmacological blockers for every pathway identified downstream from antibody binding to establish the signaling pathways most relevant to remyelination.
Research Area 4: Antigen Indentification Experiments
Antigen indentification is an important issue concerning the mechanism of action of remyelination promoting antibodies. Acorda will take the lead role in the antigen identification experiments. We will complete our experiments on the characterizatiuon of potential carbohydrate epitopes and will provide tissue to Acorda form their experiments.
Expt. 1 Determine class of carbohydrate bound by antibodies that promote remyelination.
We will treat oligodendrocytes with sialidase and related enzymes to determine class of carbohydrate bound by the antibodies. We will assess the effect of carbohydrate removal on Ca flux, protein phosphorylation and gene expression.
Expt. 2 We will isolate membrane and cell type specific antigens for antigen characterization experiments by our group and at Acorda.
7
Exhibit B
to
License Agreement between
Acorda Therapeutics, Inc. and the
Mayo Foundation for Education and Research,
dated September 8, 2000
OPTION AGREEMENT
This Option Agreement is made this October 1, 1995 by and between Mayo Foundation for Medical Education and Research, a Minnesota charitable corporation located at 200 First Street SW, Rochester, Minnesota 55905 (MAYO) and Acorda Therapeutics, Inc., a Delaware Corporation, located at 1213 Park Avenue, New York, NY 10128 (ACORDA).
This Option Agreement has three addenda: 1) Stock Warrant Agreement, referred to in Section 2.5; supplied by Acorda; 2) Appendix A, Sponsored Research Agreement; 3) Appendix B, Technology License Contract Terms Sheet.
Certain inventions relating to the promotion of remyelination by monoclonal antibodies have been made in connection with MAYOs research, patient care, and education programs. By assignment of the inventions from the developers, MAYO is the owner of certain patent rights.
ACORDA desires to evaluate such inventions for the purpose of determining its interest in obtaining a license from MAYO to sell such inventions.
Now, therefore, the parties agree as follows:
Article 1. Definitions.
1.1 Technology means:
a) U.S. patent application S.N. 08/236,520, filed April 19, 1994, and foreign patent applications and patent counterparts thereto (if any);
b) all U.S. and foreign patent applications disclosing inventions conceived or reduced to practice pursuant to the research conducted pursuant to the Sponsored Research Agreement;
c) all divisions, substitutions, continuations, continuations-in-part applications of (i) and (ii) of the preceding, and all U.S. and foreign patents issuing thereon, including reissues, reexaminations, and extensions; and
d) all trade secrets, know-how, and technical information developed by MAYO in connection with the research conducted pursuant to the Sponsored Research Agreement.
Article 2. Option.
2.1 In order for ACORDA to evaluate the commercial and technical merits of this Technology, MAYO hereby grants the Company an exclusive worldwide option to become the exclusive licensee for the Technology. Said option shall expire thirty-six (36) months from the initiation of the sponsored research described in Appendix A.
2.2 During the option period, ACORDA shall pay a maximum Two Hundred Ninety-Two Thousand Dollars ($292,000.00) to sponsor a mutually agreed upon research protocol to be performed by MAYO, according to the terms of Appendix A. Payments will be made on a quarterly basis beginning within thirty (30) days of the date whereby ACORDA accepts delivery of monoclonal antibody (ATCC Accession No. CRL-11627) from a contract manufacturer for use in MAYOs research protocol (hereby referred to as the Effective Date of this Option Agreement).
1
Notwithstanding the above, in the event that the delivery of antibody prepared on behalf of ACORDA for use in preclinical studies is delayed, through no fault of ACORDA, by more than six (6) months from the signing of this Option Agreement, the parties shall negotiate in good faith for an extension of the option, at no additional cost. Otherwise, MAYO may terminate this Option Agreement if the Effective Date of the Option Agreement is not within six (6) months of the signing of this Option Agreement. If the option to license is exercised or terminated by ACORDA before the expiration date and after twenty-four (24) months from the Effective Date of this Agreement, ACORDAs obligation to make payments to support such research shall be terminated as of that date. MAYO further agrees that it shall not negotiate with or enter into any agreement with a third party with respect to the Technology in the period from the signing of the Option Agreement until the effective date of the Option Agreement.
2.3 Should ACORDA, on or before the expiration of the option granted in 2.1 above, decide to license the Technology, then a License Agreement consistent with the terms sheet attached as Appendix B shall be negotiated and executed by both parties within ninety (90) days of ACORDAs notice to MAYO of its decision to license the Technology, or such longer period as may be agreed by the parties.
2.4 ACORDA shall pay MAYO Five Thousand Dollars ($5,000.00) within thirty (30) days of the Effective Date of this Agreement and on each anniversary thereafter during the Option period as non-refundable and non-creditable consideration for the exclusive worldwide option granted by MAYO.
2.5 As additional consideration for the exclusive worldwide option, ACORDA will issue MAYO warrants for the purchase of sixty thousand (60,000) shares of ACORDA common stock at the price of founders stock, pursuant to the terms of the Stock Warrant Agreement attached hereto. Such warrants shall be exercisable if ACORDA exercises its option to acquire a license for the Technology. The cost to MAYO for exercising its warrants will be reimbursed by ACORDA.
2.6 During the option period, ACORDA shall pay reasonable expenses associated with the prosecution of the MAYO patent application entitled Monoclonal Antibodies Which Promote Central Nervous System Remyelination (Serial No. 08/236,520) as well as the corresponding national applications filed under the Patent Cooperation Treaty; such filings to have been agreed on by MAYO and ACORDA. Only expenses incurred after March 24, 1994, and related to U.S. Patent application S.N. 08/236,520 are subject to reimbursement. The patent prosecution will be controlled by ACORDA, using counsel of ACORDAs choice, reasonably acceptable to MAYO.
2.7 During the option period, MAYO may not disclose the Technology to third parties without ACORDAs prior written consent, but MAYO shall retain the right to use the Technology for its internal research purposes.
2.8 Should ACORDA, on or before the expiration of the option granted in 2.1 above, decide not to license the Technology, MAYO shall be provided with all the research information generated during the option by ACORDA and MAYO jointly, or given to ACORDA by MAYO. All data jointly generated during the option by MAYO and ACORDA and provided to MAYO shall be only for internal use by MAYO.
2
Article 3. Confidentiality
3.1 Confidential Information is defined as any written confidential information disclosed by one party to the other and entitled to protection under this agreement which is marked CONFIDENTIAL, or words of similar import. If oral, visual, or other non-written manner of disclosure of otherwise undisclosed confidential information is made by one party to the other, such information shall be entitled to protection if identified as confidential at the time of initial disclosure and if a written notice with a summary of such disclosures is delivered to the receiving party within thirty (30) days of such disclosure. Any markings, stamps, or legends identifying confidential information shall not impose any obligations on either party inconsistent with this agreement. Any copies of the information made by the receiving party shall reproduce the confidential markings and any other legends contained on such information.
3.2 Both ACORDA and MAYO covenant and agree that they shall hold the Confidential Information they receive from the other party inviolate, keep it secret, and shall not use any such Confidential Information, except as provided in Article 4 below. The foregoing restrictions on disclosure of Confidential Information shall not apply to any information that properly comes into the public domain through no action of the other party or its agents or was already known by the other party as evidenced by its that partys written records. Each party may use its own discretion to disclose information that was independently developed by that party.
3.3 Confidential Information shall not be afforded the protection of this Agreement if, on the date of signing this Agreement, such information is or later becomes:
a) developed by the Recipient independently of the disclosed proprietary information of the other party, and reasonable written documentation exists to demonstrate such development; or
b) rightfully obtained without restriction by the Recipient from any third party who is not restricted from making such disclosure by any direct or indirect obligation of confidentiality to the other party herein; or
c) publicly available other than through the fault of the Recipient; or
d) known to the Recipient at the time of its disclosure by the other party hereto, and reasonable written documentation exists to demonstrate such knowledge.
e) subject to disclosure under a facially valid court order, warrant, or subpoena, but only if the Recipient first gives the other party immediate oral and written notice of the court order, warrant, or subpoena to permit that party to take appropriate legal action in the circumstances.
3.4 ACORDA shall not disclose, provide or otherwise make the Technology or the Confidential Information available to any person or entity other than employees, consultants, advisors, or agents of ACORDA that have signed secrecy agreements at least as restrictive as the provisions of this Agreement. Before the Confidential Information or Technology is made available to any person directly responsible for the evaluation of the Technology for licensure, ACORDA will notify the person of the obligations of confidentiality contained in this Agreement and obtain an agreement from that person to abide by said obligations.
3.5 The obligations of confidentiality stated in 3.1 and 3.2 shall survive the termination or expiration of this Agreement for five (5) years.
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Article 4. Authorized Use
4.1 During the term of this Option Agreement, ACORDA shall use the Technology and the Confidential Information only for the purpose of evaluating the Technology for licensure.
4.2 ACORDA and MAYO shall not use, expressly or by implication, any trademark or trade name of the other party, or any contraction, abbreviation, simulation or adaptation thereof, or the name of any of the other partys staff in any news, publicity release, policy recommendation, advertising or any commercial communication without the express written approval of the other party. The provisions of this Section 4.2 shall survive the Termination or expiration of this Agreement.
Article 5. Termination
5.1 Should ACORDA, on or before the expiration of the option granted in 2.1 above, decide to exercise its option and execute the License Agreement, the terms of this Option Agreement will be superseded by the terms of the License Agreement at the time the License Agreement is executed by both parties and becomes effective.
5.2 Should ACORDA, on or before the expiration of the option granted in 2.1 above, decide not to license the Technology, ACORDA may terminate this Agreement by providing written notice of its decision to MAYO. Furthermore, Section 2.2 of this Agreement remains enforceable subsequent to any termination of this Option Agreement by ACORDA, subject to the terms and conditions of the Sponsored Research Agreement.
5.3 Following nine (9) months after the Effective Date of this Option Agreement, ACORDA shall have the right to terminate its support of the Sponsored Research with ninety (90) days notice; provided ACORDA shall be obligated to pay to MAYO the salary of one (1) technician until the second anniversary of the Effective Date of the Option Agreement, unless MAYO receives contract or grant funds from an external source to support said technician.
Article 6. General
6.1 ACORDA may not assign or subcontract any of its obligations or rights under this Option Agreement without MAYOs prior, express, written consent, which consent may not be unreasonably withheld, except that ACORDA may assign its rights and obligations under this Agreement to an affiliate wholly-owned or majority-owned or controlled by ACORDA, or to any entity that acquires substantially all of the assets of ACORDA, or entities to which ACORDA has assigned all or substantially all of its assets relating to the Agreement whether by merger, acquisition, sale, operation of law, or otherwise.
6.2 This Option Agreement and its effects are subject to and shall be construed and enforced in accordance with the laws of the State of Minnesota except that no part of Minnesota law shall apply that directs the application of another jurisdictions law.
6.3 The failure of either party to insist at any time upon the strict observance or performance of any of the provisions of the Option Agreement, or to exercise any right or remedy as provided in this Option Agreement, shall not impair any such right or remedy and shall not be construed to be a waiver or relinquishment. Furthermore, no waiver of any provision of this
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Option Agreement by either party shall be construed as a waiver of any other provision or as a waiver of the same provision at any subsequent time.
6.4 This Option Agreement (including Appendixes A and B) constitutes the entire agreement between the parties and supersedes all prior or contemporaneous, oral and written agreements, proposals and discussions relating to the same subject matter. The Option Agreement may be amended only through a writing signed by each of the parties.
6.5 Neither party shall disclose the terms of this Agreement to any third party, and neither party shall issue any press release or other statement to the media regarding the existence of the Agreement or its subject matter (if the other party is mentioned) without the prior written consent of the other party.
IN WITNESS WHEREOF , each of the parties has caused this Agreement to be executed on its behalf by its duly authorized representative.
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THESE SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933 (THE ACT). THEY MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED, OR HYPOTHECATED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT AS TO THE SECURITIES UNDER THE ACT OR AN OPINION OF COUNSEL, SATISFACTORY TO THE COMPANY, THAT SUCH REGISTRATION IS NOT REQUIRED.
THE SALE OF THESE SECURITIES HAS NOT BEEN QUALIFIED WITH ANY STATE SECURITIES AUTHORITIES. THE RIGHTS OF ALL PARTIES TO THIS WARRANT ARE EXPRESSLY CONDITIONED UPON SUCH QUALIFICATION BEING OBTAINED UNLESS THE SALE IS SO EXEMPT.
THIS WARRANT MAY NOT BE EXERCISED EXCEPT IN COMPLIANCE WITH ALL APPLICABLE FEDERAL AND STATE SECURITIES LAWS TO THE REASONABLE SATISFACTION OF THE COMPANY AND LEGAL COUNSEL FOR THE COMPANY.
STOCK WARRANT AGREEMENT
To Purchase 60,000 Shares of the Common Stock of
ACORDA THERAPEUTICS, INC.
Dated as of October , 1995
1. GRANT OF THE RIGHT TO PURCHASE COMMON STOCK .
For value received, Acorda Therapeutics, Inc., a Delaware corporation (the Company), hereby grants to Mayo Foundation for Medical Education and Research, a Minnesota charitable corporation (the Warrantholder), and the Warrantholder is entitled, upon the terms and subject to the conditions hereinafter set forth, to subscribe for and purchase from the Company up to 60,000 fully paid and non-assessable shares of the Companys Common Stock (Common Stock). This Warrant Agreement is entered between the parties and the rights to purchase Common Stock are granted pursuant to Section 2.5 of the Option Agreement of even date herewith between the Company and the Warrantholder (the Option Agreement). The purchase rights set forth in this Warrant Agreement shall become exercisable immediately upon the Companys exercise of its option as set forth in the Option Agreement to license certain technology of the Warrantholder. The exercise price (Exercise Price) shall be equal to $0.01 per share. The number and purchase price of such shares are subject to adjustment as provided in Section 8 hereof.
2. TERM Of THE WARRANT AGREEMENT .
Except as otherwise provided for herein, the term of this Warrant Agreement and the right to purchase Common Stock as granted herein shall commence on the date of this Agreement and shall expire upon the first to occur of (i) the expiration of the Option Agreement in accordance with its terms, (ii) the effective date of the Companys firmly underwritten initial public offering pursuant to a registration statement filed with the United States Securities and Exchange Commission under the Securities Act of 1933, as amended (the Securities Act), or (iii) the completion date of the sale of the Company, or of
all or substantially all of its assets, by merger, acquisition, or otherwise (in which the stockholders of the Company immediately prior to such sale hold less than a majority-in-interest of the voting equity of any successor corporation following such sale), or the sale of all or substantially all of the assets of the Company.
3. EXERCISE OF THE PURCHASE RIGHTS .
Subject to Section 1 above, the purchase rights set forth in this Warrant Agreement are exercisable by the Warrantholder, in whole or in part, at any time or from time to time, prior to the expiration of the term set forth in Section 2 above, by tendering to the Company at its principal office a notice of exercise in the form attached hereto as Exhibit I (the Notice of Exercise), duly completed and executed. Upon receipt of the Notice of Exercise and the payment of the purchase price in accordance with the terms set forth below, the Company shall issue to the Warrantholder a certificate for the number of shares of Common Stock purchased and shall execute the Notice of Exercise indicating the number of shares which remain subject to future purchases, if any.
The Warrantholder may either (i) exercise all or any portion of the outstanding warrants by paying to the Company, by cash or check, an amount equal to the aggregate Exercise Price of the shares being purchased or (ii) receive shares equal to the value (as determined below) of this Warrant by surrender of the Warrant at the principal office of the Company together with notice of such election in which event the Company shall issue to the Warrantholder a number of shares of Common Stock computed using the following formula:
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X = |
Y(A-B) |
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A |
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Where: |
X = The number of shares of Common to be issued to the Warrantholder. |
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Y = The number of shares of Common to be exercised under this Warrant. |
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A = The fair market value of one share of Common. |
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B = The Exercise Price. |
As used herein, current fair market value of Common Stock shall mean with respect to each share of Common Stock the average of the closing prices of the Companys Common Stock sold on all securities exchanges on which the Common Stock may at the time be listed, or, if there have been no sales on any such exchange on any day, the average of the highest bid and lowest asked prices on all such exchanges at the end of such day, or, if on any day the Common Stock is not so listed, the average of the representative bid and asked prices quoted in the NASDAQ System as of 4:00 p.m., New York City time, or, of on any day the Common Stock is not quoted in the NASDAQ System, the average of the highest bid and lowest asked price on such day in the domestic over-the-counter market as reported by the National Quotation Bureau, Incorporated, or any similar successor organization, in each such case averaged over a period of 10 days consisting of the day as of which the current fair market value of
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Common Stock is being determined and the 9 consecutive business days prior to such day. If at any time the Common Stock is not listed on any securities exchange or quoted in the NASDAQ System or the over-the-counter market, the current fair market value of Common Stock shall be the highest price per share which the Company could obtain from a willing buyer (not a current employee or director) for shares of Common Stock sold by the Company, from authorized but unissued shares, as determined in good faith by the Board of Directors of the Company, unless (i) the Company shall become subject to a merger, acquisition, or other consolidation pursuant to which the Company is not the surviving party, in which case the current fair market value of the Common Stock shall be deemed to be the value received by the holders of the Companys stock for each share of stock, pursuant to the Companys acquisition or (ii) the Warrantholder shall purchase such shares in conjunction with the initial underwritten public offering of the Companys Common Stock pursuant to a registration statement filed under the Securities Act, in which case, the fair market value of the shares of stock subject to this Warrant shall be the price at which all registered shares are sold to the public in such offering.
4. RESERVATION OF SHARES .
During the term of this Warrant Agreement, the Company will at all times have authorized and reserved a sufficient number of shares of its Common Stock to provide for the exercise of the rights to purchase Common Stock as provided for herein.
5. NO FRACTIONAL SHARES OR SCRIP .
No fractional share or scrip representing fractional shares shall be issued upon the exercise of the Warrantholders right to purchase Common Stock, but in lieu of such fractional shares the Company shall make a cash payment therefor upon the basis of the Exercise Price then in effect.
6. NO RIGHTS AS STOCKHOLDERS .
The Warrant Agreement does not entitle the Warrantholder to any voting right or other rights as a stockholder of the Company prior to the exercise of the Warrantholders rights to purchase Common Stock as provided for herein.
7. WARRANTHOLDER REGISTRY .
The Company shall maintain a registry showing the name and address of the registered holder of this Warrant Agreement.
8. ADJUSTMENT RIGHTS .
The purchase price per share and the number of shares of Common Stock purchasable hereunder are subject to adjustment from time to time, as follows:
(a) Merger . If at any time there shall be a capital reorganization of the shares of the Companys stock (other than a combination, reclassification, exchange, or subdivision of shares otherwise
3
provided for herein), or a merger or consolidation of the Company with or into another corporation when the Company is not the surviving corporation (but its stockholders nevertheless control not less than a majority-in-interest of the voting equity of any successor corporation), then, as a part of such reorganization, merger, or consolidation, lawful provision shall be made so that the Warrantholder shall thereafter be entitled to receive upon exercise of its rights to purchase Common Stock, the number of shares of common stock or other securities of the successor corporation resulting from such reorganization, merger or consolidation, to which a holder of the Common Stock deliverable upon exercise of the right to purchase Common Stock hereunder would have been entitled in such reorganization, merger or consolidation if the right to purchase such Common Stock hereunder had been exercised immediately prior to such reorganization, merger or consolidation. In any such case, appropriate adjustment (as determined in good faith by the Companys Board of Directors) shall be made in the application of the provisions of this Warrant Agreement with respect to the rights and interests of the Warrantholder after the reorganization, merger, or consolidation to the end that the provisions of this Warrant Agreement (including adjustments of the Exercise Price and number of shares of Common Stock purchasable pursuant to the terms and conditions of this Warrant Agreement) shall be applicable after the event, as near as reasonably may be, in relation to any shares deliverable after that event upon the exercise of the Warrantholders rights to purchase Common Stock pursuant to this Warrant Agreement.
(b) Reclassification of Shares . If the Company at any time shall, by combination, reclassification, exchange, or subdivision of securities or otherwise, change any of the securities as to which purchase rights under this Warrant Agreement exist into the same or a different number of securities of any other class or classes, this Warrant Agreement shall thereafter represent the right to acquire such number and kind of securities as would have been issuable as the result of such change with respect to the securities which were subject to the purchase rights under this Warrant Agreement immediately prior to such combination, reclassification, exchange, subdivision, or other change.
(c) Subdivision or Combination of Shares . If the Company at any time shall combine or subdivide its Common Stock, the Exercise Price shall be proportionately decreased in the case of a subdivision, or proportionately increased in the case of a combination.
(d) Notice of Adjustments . In the event that (i) the Company shall declare any dividend or distribution upon its stock, whether in cash, property, stock, or other securities; (ii) the Company shall offer for subscription pro rata to the holders of any class of its Common or other convertible stock any additional shares of stock of any class or other rights; (iii) there shall be any capital reorganization, reclassification, consolidation, merger or sale of all or substantially all of the Companys assets; or (iv) there shall be any voluntary or involuntary dissolution, liquidation, or winding up of the Company, then, in connection with each such event, the Company shall send to the Warrantholder:
(i) At least 20 days prior written notice of the date on which the books of the Company shall close or a record shall be taken for such dividend, distribution, subscription rights (specifying the date on which the holders of Common Stock shall be entitled thereto) or for determining rights to vote in respect of such capital reorganization, reclassification, consolidation, merger, dissolution, liquidation, or winding up; and
4
(ii) In the case of any such capital reorganization, reclassification, consolidation, merger or sale of all or substantially all of the Companys assets, dissolution, liquidation or winding up, at least 20 days prior written notice of the date when the same shall take place and specifying the date on which the holders of Common Stock shall be entitled to exchange their Common Stock for securities or other property deliverable upon such capital reorganization, reclassification, consolidation, merger, or sale of all or substantially all of the Companys assets, dissolution, liquidation, or winding up).
Each such written notice shall set forth, as applicable and in reasonable detail, (i) the event requiring the adjustment, (ii) the amount of the adjustment, (iii) the method by which such adjustment was calculated, (iv) the Exercise Price, and (v) the number of shares subject to purchase hereunder after giving effect to such adjustment, and shall be given by first class mail, postage prepaid, addressed to the Warrantholder, at the address as shown on the books of the Company.
9. REPRESENTATIONS AND COVENANTS OF THE WARRANTHOLDER .
This Warrant Agreement has been entered into by the Company in reliance upon the following representations and covenants of the Warrantholder, which by its execution hereof the Warrantholder hereby confirms:
(a) Investment Purpose . The Common Stock issuable upon exercise of the Warrantholders rights contained herein will be acquired for investment and not with a view to the sale or distribution of any part thereof, and the Warrantholder has no present intention of selling or engaging in any public distribution of the same except pursuant to a registration or exemption.
(b) Private Issue . The Warrantholder understands (i) that the Common Stock issuable upon exercise of the Warrantholders rights contained herein is not registered under the Securities Act or qualified under applicable state securities laws on the ground that the issuance contemplated by this Warrant Agreement will be exempt from the registration and qualifications requirements thereof and (ii) that the Companys reliance on such exemption is predicated on the representations set forth in this Section 9.
(c) Disposition of Warrantholders Rights . In no event will the Warrantholder make a disposition of any of its rights to acquire Common Stock issuable upon exercise of such rights unless and until (i) it shall have notified the Company of the proposed disposition and (ii) if requested by the Company, it shall have furnished the Company with an opinion of counsel (which counsel may either be inside or outside counsel to the Warrantholder) satisfactory to the Company and its counsel to the effect that (A) appropriate action necessary for compliance with the Securities Act has been taken, or (B) an exemption from the registration requirements of the Securities Act is available. Notwithstanding the foregoing, the restrictions imposed upon the transferability of any of its rights to acquire Common Stock issuable on the exercise of such rights do not apply to transfers from the beneficial owner of any of the aforementioned securities to its nominee or from such nominee to its beneficial owner, and shall terminate as to any particular share of Common Stock when (1) such security shall have been effectively registered under the Securities Act and sold by the holder thereof in accordance with such registration or (2) such
5
security shall have been sold without registration in compliance with Rule 144 under the Securities Act, or (3) a letter shall have been issued to the Warrantholder at its request by the staff of the United States Securities and Exchange Commission or a ruling shall have been issued to the Warrantholder at its request by such Commission stating that no action shall be recommended by such staff or taken by such Commission, as the case may be, if such security is transferred without registration under the Securities Act in accordance with the conditions set forth in such letter or ruling and such letter or ruling specifies that no subsequent restrictions on transfer are required. Whenever the restrictions imposed hereunder shall terminate, as hereinabove provided, the Warrantholder or holder of a share of Common Stock then outstanding as to which such restrictions have terminated shall be entitled to receive From the Company, without expense to such holder, one or more new certificates for the Warrant or for such shares of Common Stock not bearing any restrictive legend.
(d) Financial Risk . The Warrantholder has such knowledge and experience in financial and business matters as to be capable of evaluating the merits and risks of its investment and has the ability to bear the economic risks of its investment.
(e) Risk of No Registration . The Warrantholder understands that if the Company does not register with the Securities and Exchange Commission pursuant to Section 12 of the Securities Exchange Act of 1934 (the Exchange Act), or file reports pursuant to Section 15(d) of the Exchange Act, or if a registration statement covering the securities under the Securities Act is not in effect when it desires to sell the Common Stock issuable upon exercise of the right to purchase, it may be required to hold such securities for an indefinite period. The Warrantholder also understands that any sale of its Common Stock which might be made by it in reliance upon Rule 144 under the Securities Act may be made only in accordance with the terms and conditions of that Rule.
10. TRANSFERS .
This Warrant may not be transferred in any manner otherwise than by will or by the laws of descent or distribution and may be exercised only by the Warrantholder or his permitted assignee. Any transfer of this Warrant must comply with the requirements of this Section 10, and any assignee or transferee of this Warrant (permitted assignee) shall be required to accept this Warrant subject to all rights and obligations of the Warrantholder as set forth herein. Any securities to be issued upon exercise of this Warrant may not be sold, assigned, transferred or otherwise disposed of unless the securities are registered under the Securities Act or unless the person seeking to effect such disposition shall have requested and the Company shall have received an opinion of the Companys counsel that the proposed disposition may be effected without registration of such securities under the Securities Act or any applicable state securities laws. Unless a registration statement with respect to such shares of Common Stock is effective at the time, any shares of Common Stock issued upon the exercise of this Warrant shall bear the following legend:
6
THE SECURITIES REPRESENTED BY THIS CERTIFICATE HAVE MOT BEEN REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED THE (ACT). THEY MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED, OR HYPOTHECATED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT AS TO THE SECURITIES UNDER THE ACT OR AN OPINION OF COUNSEL, SATISFACTORY TO THE COMPANY, THAT REGISTRATION IS NOT REQUIRED.
11. MARKET STANDOFF AGREEMENT .
The Warrantholder hereby agrees, if so requested by the managing underwriters in an initial public offering by the Company of its Common Stock, that, without the prior written consent of such managing underwriters, the Warrantholder will not offer, sell, contract to sell, grant any option to purchase, make any short sale, or otherwise dispose of or make a distribution of any capital stock of the Company held by or on behalf of the Warrantholder or beneficially owned by the Warrantholder in accordance with the rules and regulations of the United States Securities and Exchange Commission for a period of up to 180 days after the date of the final prospectus relating to the Companys initial public offering.
12. MLSCELLANEOUS .
(a) Effective Date . The provisions of this Warrant Agreement shall be construed and shall be given effect in all respects as if it had been executed and delivered by the Company on the date hereof. This Warrant Agreement shall be binding upon any successors or assigns of the Company.
(b) Attorneys Fees . In any litigation, arbitration or court proceeding between the Company and the Warrantholder relating hereto, the prevailing party shall be entitled to attorneys fees and expenses and all costs of proceedings incurred in enforcing this Warrant Agreement.
(c) Governing Law . This Warrant Agreement shall be governed by and construed for all purposes under and in accordance with the laws of the State of Delaware as applied to agreements between Delaware residents entered and to be performed entirely within Delaware.
(d) Counterparts . This Warrant Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
(e) Titles and Subtitles . The titles of the paragraphs and subparagraphs of this Warrant Agreement are for convenience and are not to be considered in construing this Agreement.
(f) Notices . Any notice required or permitted hereunder shall be given in writing and shall be deemed effectively given upon personal delivery or upon deposit in the United States mail, by registered or certified mail, addressed (i) to the Warrantholder at the address set forth on the signature
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page hereof and (ii) to the Company at its principal executive offices to the attention of its president or at such other address as any such party may subsequently designate by written notice to the other party.
(g) Survival . The representations, warranties, covenants and conditions of the respective parties contained herein or made pursuant to this Warrant Agreement shall survive the execution and delivery of this Warrant Agreement.
(h) Amendments . Any provision of this Warrant Agreement may be amended by a written instrument signed by the Company and by the Warrantholder.
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IN WITNESS WHEREOF, the parties hereto have caused this Warrant Agreement to be executed by its officers thereunto duly authorized.
9
EXHIBIT I
NOTICE OF EXERCISE
Ron Cohen, M.D.
To: Acorda Therapeutics, Inc.
(1) The undersigned Warrantholder hereby elects to purchase 60,000 shares of the Common Stock of ACORDA THERAPEUTICS, INC., pursuant to the terms of the Warrant Agreement dated the day of October, 1995 (the Warrant Agreement) between ACORDA THERAPEUTICS, INC. and the Warrantholder, and tenders herewith payment of the purchase price for such shares in full, together with all applicable transfer taxes, if any.
(2) In exercising its rights to purchase the Common Stock of ACORDA THERAPEUTICS, INC., the undersigned hereby confirms and acknowledges the investment representations and warranties made in Section 9 of the Warrant Agreement.
(3) Please issue a certificate or certificates representing said shares of Common Stock in the name of the undersigned or in such other name as is specified below.
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Mayo Foundation for Medical Education |
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200 First Street SW
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Warrantholder: |
Mayo Foundation
for Medical
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By: |
/s/ R ick F. Colvin |
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Rick F. Colvin |
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Assistant Treasurer |
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Date: |
10/6/00 |
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10
Appendix A
to
Acorda/Mayo Option Agreement dated October 1, 1995
(Included as Exhibit A to License Agreement between
Acorda Therapeutics, Inc. and the
Mayo Foundation for Education and Research,
dated September 8, 2000)
ACORDA - MAYO
CLINIC
License Agreement Terms
License: |
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Mayo Clinic (Mayo) will grant Acorda an exclusive license, with the right to grant and authorize sublicenses, under the Licensed Patents to make, have made, use and sell Licensed Products in the Territory. |
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Territory: |
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Worldwide. |
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Licensed Technology: |
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Licensed Technology includes (i) the Licensed Patents and (ii) Project Know How. |
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Licensed Patents: |
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Licensed Patents include (i) the patent applications listed on Exhibit A hereto, (ii) all patent applications filed with respect to inventions conceived or otherwise developed in the course of and in connection with the Sponsored Research, and (iii) all divisions, substitutions, continuations, continuations-in-part applications, and reissues, re-examinations, and extensions of (i) and (ii) above, all patents issuing on the preceding, and all foreign counterparts of the preceding. |
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Project Know-How: |
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All trade secrets and other intellectual property conceived or otherwise developed in the course of and in connection with the Sponsored Research, and all subsequent modifications, enhancements and improvements, excluding the patent applications and patents within the Licensed Patents. |
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Licensed Products: |
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Products covered by a valid issued or pending claim of a Licensed Patent in the country which such Product is sold, or which directly incorporate Project Know-How. |
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Licensed Technology, or reimbursement for patent or other expenses. |
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In the event that a Licensed Product is sold in combination with another product which is not a Licensed Product, the amount paid to Mayo shall be based on the proportion of the value of such combination product reasonably attributable to the Licensed Technology; provided in no event shall Mayo receive less than 0.25% of the net sales of Licensed Products sold by Acorda. |
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Due Diligence: |
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Acorda will use reasonable efforts to enter into an agreement with a contract manufacturer for the production of Mayos mylenating monoclonal antibody, by the later of June 1, 1995, or within sixty (60) days following the close of Acordas Series A financing. |
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Acorda will use reasonable commercial efforts, consistent with its prudent business judgment, to develop Licensed Products and obtain and maintain such approvals as may be necessary for the sale of Licensed Products in the U.S. and such other worldwide markets as Acorda elects to sell such Licensed Products. |
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Milestone Payments: |
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Acorda will pay to Mayo the following amounts on the achievement of the following events: |
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Effective Date of license |
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25,000 |
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Issue of first U.S. patent within the Licensed Patents |
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25,000 |
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Initiation of Phase I clinical trials for the first Licensed Product |
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50,000 |
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FDA marketing approval of the first Licensed Product |
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$ |
500,000 |
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Patent Prosecution: |
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Acorda will be responsible, using patent counsel of its choice, for preparing, filing, prosecuting and maintaining patent applications and patents within the Licensed Patents. Acorda will pay the costs incurred in connection with such activities, and reimburse Mayo for reasonable costs incurred in connection with such activities prior to the effective date of the license; 50% of all such amounts (including attorneys fees) shall be creditable against earned royalties due Mayo. At Mayos request, Acorda shall provide Mayo with reasonable documentation of such costs. Mayo and Acorda will cooperate and consult with each other in the prosecution of the Licensed Patents. |
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Patent Enforcement: |
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In the event of any infringement of the Licensed Patents or misappropriation of the Project Know-How, the parties shall consult to determine if they will jointly bring action to terminate such infringement or misappropriation. Any recovery obtained by the parties in such an action shall be used first to reimburse the costs of such action, and the remainder divided equally between the parties. |
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In the event that the parties fail to initiate such action within ninety (90) days of receiving notice of such infringement or misappropriation, Mayo shall have the right, but not the obligation, to initiate suit to stop such infringement or misappropriation; provided if Mayo does not initiate such an action within a further ninety (90) days, Acorda shall have the right to pursue any infringement of the Licensed Patents, or opposition or interference with respect thereto, or any misappropriation of Project Know-How, or defend any declaratory judgment relating thereto. Any recovery obtained by |
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Acorda in such an action shall be used first to reimburse the costs of such action, and the remainder shall be retained by Acorda and treated as net sales of Licensed Products, subject to the royalty obligations to Mayo herein. |
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Royalties to Third Parties: |
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In the event that in connection with its sale of Licensed Products, Acorda pays a third party royalties or other amounts to avoid or settle a claim of infringement of the intellectual property rights of such third party, Acorda may offset such amounts against up to 50% of the amounts due Mayo; provided, however, in no event shall Mayo receive less than 0.25% of the net sales of Licensed Products sold by Acorda and its affiliates. |
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Sublicenses: |
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Any sublicenses granted by Acorda under the Licensed Technology shall remain in effect and be assigned to Mayo in the event this license terminates. |
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Assignment: |
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Acorda may not assign the license without the consent of Mayo, which consent shall not be unreasonably withheld; provided, Acorda may assign the license in connection with the sale or transfer of all or substantially all the rights and obligations of Acorda relating to the Licensed Products , without the prior consent of Mayo. |
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Term: |
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The license shall terminate on a country-by-country basis upon the expiration of the last to expire Licensed Patent in such country, or, if no Licensed Patent issues in a country, twelve years following the first commercial sale of a Licensed Product in such country, on a Licensed Product-by-Licensed Product basis. Acorda shall have the right to terminate the license agreement with respect to any Licensed |
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Technology or any country, on ninety (90) days written notice. |
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Other: |
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The formal agreement will include other customary provisions to be agreed by the parties, including indemnification, royalty reporting, audit rights and the like. |
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Amendment No. 1 to Option Agreement
This Amendment No. 1 to Option Agreement (the Amendment) is effective as of October 2, 1995 between Acorda Therapeutics, Inc. (Acorda) and Mayo Foundation for Medical Education and Research (Mayo) concerning the Option Agreement between Acorda and Mayo effective October 1, 1995.
1. The parties have agreed to broaden the scope of the Technology to include certain additional monoclonal antibodies.
2. Section 1.1(a) is hereby amended to read in its entirety as follows:
(a) U.S. patent application S.N. 08/236, 520, filed April 19, 1994, and all patent applications disclosing any invention or other intellectual property developed by Moses Rodriguez, M.D. and owned in whole or part by MAYO relating to monoclonal antibodies associated with myelination, or derivatives and analogs thereof, including without limitation, compositions and methods of making and using thereof, and foreign patent applications and patent counterparts thereto (if any);
3. Add new Section 1.l(e), which provides in its entirety:
(e) the biological materials listed on Exhibit A hereto.
4. Section 2.6 is hereby amended to read in its entirety as follows:
2.6 During the option period, ACORDA shall pay reasonable expenses associated with the prosecution of the MAYO patent application entitled Monoclonal Antibodies Which Promote Central Nervous System Remyelination (Serial No. 08/236, 520) and other patent applications included in Section 1.1(a) above, as well as the corresponding national applications filed under the Patent Cooperation Treaty; such filings to have been agreed on by MAYO and ACORDA. Only expenses incurred after March 24, 1994, and related to the preceding patent applications are subject to reimbursement. The patent prosecution will be controlled by ACORDA, using counsel of ACORDAs choice, reasonably acceptable to MAYO.
5. Except as specifically modified or amended hereby, the Option Agreement shall remain in full force and effect and, as so modified or amended, is hereby ratified, confirmed and approved. No provision of this Amendment may be modified or amended except expressly in a writing signed by both parties nor shall any terms be waived except expressly in writing signed by the party charged therewith. This Amendment shall be governed in accordance with the laws of the State of Minnesota, without reference to principles of conflicts of laws.
IN WITNESS WHEREOF , the parties have duly executed this Amendment as of the date shown above.
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ACORDA THERAPEUTICS, INC. |
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/s/ Ron Cohen |
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Ron Cohen, MD |
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President & CEO |
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MAYO
FOUNDATION FOR
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/s/ Rick F. Colvin |
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Rick F. Colvin |
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Assistant Treasurer |
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Exhibit A
to Amendment Number 1 to Option Agreement
between
Mayo Foundation for Medical Education and Research
and
Acorda Therapeutics, Inc.
Biologic materials include:
1. monoclonal antibody 94.03
2. monoclonal antibody SCH 79.03
This list may be amended from time to time during the course of the Agreement.
Wednesday, July 31, 1996
Susan
Stoddard, Ph.D.
Mayo Medical Ventures
200 First Street S.W.
Rochester, MN 55905
Dear Susan:
This letter confirms that, with regard to the Option Agreement (the Agreement) of October 1, 1995 between Acorda Therapeutics, Inc. (Acorda) and the Mayo Foundation for Medical Education and Research (Mayo), relating to U.S. patent application S.N. 08/236, 520, Acorda and Mayo agree that the Effective Date of the Option Agreement may be extended up to December 1, 1996.
All other provisions of the Agreement shall remain in effect unless amended in writing by mutual agreement of Acorda and Mayo.
If the foregoing is satisfactory, please sign, or have another appropriate representative of Mayo sign, both copies of this letter to indicate Mayos agreement, and return one copy to my attention at Acorda.
Thank you for your consideration. If you have any questions, please do not hesitate to call.
Sincerely yours, |
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/s/ Ron Cohen |
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Ron Cohen, M.D. |
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President and Chief Executive Officer |
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AGREED TO by the |
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MAYO FOUNDATION FOR MEDICAL |
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EDUCATION AND RESEARCH: |
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Signed: |
/s/ Rick F. Colvin |
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Name: |
Rick F. Colvin |
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Title: |
Assistant Treasurer |
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Date: |
8/9/96 |
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145 WEST 58TH STREET |
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NEW YORK, NY 10019 |
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FAX: (212) 765-8637 |
SUITE #8J |
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PHONE: (212) 376-7552 |
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E-MAlL: DRRON18@ADL.COM |
JAN 6
December 31, 1996
Susan Stoddard, Ph.D.
Mayo Medical Ventures
200 First Street S.W.
Rochester, MN 55905
Dear Susan:
This letter (the Second Extension Letter) confirms that, with regard to the Option Agreement (the Agreement) of October 1, 1995 between Acorda Therapeutics, Inc. (Acorda) and the Mayo Foundation for Medical Education and Research (Mayo), relating to U.S. patent application S.N. 08/236, 520, and with regard to the letter of July 31, 1996 extending the Effective Date of the Option Agreement up to December 1, 1996 (the First Extension Letter), Acorda and Mayo agree that the Effective Date of the Option Agreement may be extended up to January 2, 1997, and that this Second Extension Letter supersedes the First Extension Letter.
All other provisions of the Agreement shall remain in effect unless amended in writing by mutual agreement of Acorda and Mayo.
If the foregoing is satisfactory, please sign, or have another appropriate representative of Mayo sign, both copies of this letter to indicate Mayos agreement, and return one copy to my attention at Acorda.
Thank you for your consideration. If you have any questions, please do not hesitate to call.
Sincerely yours, |
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/s/ Ron Cohen |
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Ron Cohen, M.D. |
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President and Chief Executive Officer |
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AGREED TO by the |
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MAYO FOUNDATION FOR MEDICAL |
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EDUCATION AND RESEARCH: |
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Signed: |
/s/ Rick F. Colvin |
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Name: |
Rick F. Colvin |
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Title: |
Assistant Treasurer |
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Date: |
1/7/97 |
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145 WEST 58TH STREET |
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NEW YORK, NY 10019 |
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FAX: (212) 765-8637 |
SUITE #8J |
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PHONE: (212) 376-7552 |
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E-MAlL: DRRON18@ADL.COM |
ACORDA/MAYO
Amendment No. 3 to Option Agreement
This Amendment No. 3 to Option Agreement (the AMENDMENT) is effective as of March 15, 1998 between Acorda Therapeutics, Inc. (ACORDA) and Mayo Foundation for Medical Education and Research (MAYO) concerning the Option Agreement between Acorda and Mayo Effective October 1, 1995.
1. The parties have agreed to include humanization of MAbs by Larry Pease, Ph.D, and Moses Rodriguez, M.D.
2. Section 1.1 (a) is hereby amended to read in its entirety as follows;
(a) U.S. patent application S.N. 08/236,520, filed April 19, 1994, and all patent applications disclosing any invention or other intellectual property developed in whole or in part by Moses Rodriguez and/or Larry Pease owned in whole or in part by MAYO relating to humanized and non-humanized monoclonal antibodies associated with myelination and/or remyelination, or derivatives and analogs thereof, including without limitation, compositions and methods of making and using thereof, and foreign patent applications and counterparts thereto (if any);
3. Except as specifically modified or amended hereby or in Amendment No. 1 to the Option Agreement, the Option Agreement shall remain in full force and effect and, as so modified or amended, is hereby ratified, confirmed and approved. No provision of this Amendment may be modified or amended except expressly in a writing signed by the party charged therewith. This amendment shall be governed in accordance with the laws of the State of Minnesota, without reference to principals of conflicts of laws.
IN WITNESS WHEREOF, the parties have duly executed this Amendment as of the date shown above.
MAYO
FOUNDATION FOR MEDICAL
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ACORDA THERAPEUTICS, INC. |
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Signed: |
/s/ John H. Herrell |
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Signed: |
/s/ Ron Cohen, M.D. |
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Name: |
John H. Herrell |
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Name: |
Ron Cohen, M.D. |
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Title: |
Vice President |
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Title: |
President & CEO |
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Date: |
March 24, 1998 |
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Date: |
3/20/98 |
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Acorda/Mayo Option & Res Agr (Rodriguez/Pease) |
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Confidential |
ACORDA/MAYO
OPTION TO LICENSE, SPONSORED RESEARCH AGREEMENT
AND LICENSE TERM SHEET
This Option Agreement is made with an Effective Date of March 15, 1998 by and between Mayo Foundation for Medical Education and Research, a Minnesota charitable corporation located at 200 First Street SW, Rochester, Minnesota 55905 (MAYO) and Acorda Therapeutics, Inc., a Delaware Corporation, located at 145 West-58th Street, Suite 8J, New York, NY 10019 (ACORDA).
This Option Agreement has four addenda 1) Exhibit A, Sponsored Research Agreement; 2) Exhibit B, Statement of Work and Budget, 3) Exhibit C, Technology License Contract Term Sheet, and 4) Exhibit D, Mayo/Acorda Agreements
Certain Inventions relating to the prevention, mitigation and/or treatment of nervous system disorders, diseases or injuries by monoclonal antibodies have been made in connection with MAYOs research, patient care, and education programs. By assignment of the inventions from the developers, MAYO is the owner of certain patent rights.
ACORDA desires to evaluate such inventions for the purpose of determining its interest in obtaining a license from MAYO to sell such inventions.
Now, therefore, the parties agree as follows:
Article 1. Definitions.
1.1 Technology means:
a) U.S. patent application S.N. 08/263,520, filed April 19, 1994, foreign patent applications and patent counterparts thereto (if any), and all patent applications disclosing any invention or other intellectual property developed in whole or in
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part by Moses Rodriguez and/or Larry Pease owned in whole or in part by MAYO relating to monoclonal antibodies and pooled IgM for use in the prevention, mitigation and/or treatment of nervous system disorders, diseases or injuries, including without limitation pain, or derivatives and analogs thereof, excluding the Technology subject to the Option Agreement entered by ACORDA and MAYO October 1, 1995, as amended;
b) all U.S. and foreign patent applications disclosing inventions conceived or reduced to practice pursuant to the research conducted pursuant to the Sponsored Research Agreement;
c) all divisions, substitutions, continuations, continuations-in-part applications of (a) and (b) of the preceding, and all U.S. and foreign patents issuing thereon, including reissues, reexaminations, and extensions; and
d) all trade secrets, know-how, and technical information developed by MAYO in connection with the research conducted pursuant to the Sponsored Research Agreement.
1.2 Territory means world-wide including but not limited to North America, Europe, Pacific Rim and Australia, Africa and the Middle East, South America, and the United States and its territories.
Article 2. Option.
2.1 In order for ACORDA to evaluate the commercial and technical merits of this Technology, MAYO hereby grants the Company an exclusive worldwide option in the Territory to become the exclusive licensee for the Technology. Said option shall expire the earlier of thirty-six (36) months from the start of the sponsored research program (the Effective Date) or the termination of minimum funding of such sponsored research program by ACORDA as described in Exhibits A and B. This option agreement may be extended by mutual written agreement of the parties.
2.2 During the option period, ACORDA shall pay a minimum of (Two Hundred Thirty-Three Four-Hundred Thirty-One Dollars ($233,431.00) to sponsor a mutually agreed upon research protocol to be performed by MAYO, according to the terms of Exhibits A and B.
2.3 Should ACORDA, on or before the expiration of the option granted in 2.1 above, decide to license the Technology, then a License Agreement consistent with the terms sheet attached as Exhibit C shall be negotiated and executed by both parties within ninety (90) days of ACORDAs notice to MAYO of its decision to license the Technology, or such longer period as may be agreed to In writing by the parties.
2.4 ACORDA shall pay MAYO Five Thousand Dollars ($5,000.00) within thirty (30) days of the Effective Date of this Option Agreement and on each anniversary thereafter as non-refundable and non-creditable consideration for the exclusive worldwide option granted by MAYO.
2.5 During the option period, ACORDA shall pay reasonable expenses associated with the prosecution of patent applications disclosing any invention or other intellectual property owned in whole or in part by MAYO relating to monoclonal antibodies and pooled IgM for use in the prevention, mitigation and/or treatment of nervous system disorders, diseases or injuries, including without limitation pain, or derivatives and analogs thereof, including without
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limitation compositions and methods of making and using thereof, excluding the Technology subject to the Option Agreement entered by ACORDA and MAYO October 1, 1995, as amended. The patent prosecution will be controlled by ACORDA, using counsel of ACORDAs choice, reasonably acceptable to MAYO.
Notwithstanding the above, in the event ACORDA chooses not to prosecute patent applications for an invention ACORDA shall notify MAYO in writing of such decision within sixty (60) days prior to the time action is required to avoid abandoning said patent. Once notified, MAYO shall have the right to prosecute patent applications for said invention independent of ACORDA. If MAYO prosecutes patent applications for said inventions ACORDA will have no further rights to those inventions and MAYO is free to license said inventions to third parties with no further obligation to ACORDA.
2.6 During the option period, MAYO may not disclose the Technology to third parties without ACORDAs prior written consent, but MAYO shall retain the nontransferable right to use the Technology for its internal research purposes.
2.7 Should ACORDA, on or before the expiration of the option granted in 2.1 above, decide not to license the Technology, MAYO shall be provided with all the research information generated during the option period by ACORDA and MAYO jointly, or given to ACORDA by MAYO.
2.8 All data jointly generated during the option period by MAYO and ACORDA and provided to MAYO shall be only for internal use by MAYO during the option period.
Article 3. Confidentiality
3.1 Confidential Information is defined as any written confidential information disclosed by one party to the other and entitled to protection under this agreement which is marked CONFIDENTIAL, or words of similar import. If oral, visual, or other non-written manner of disclosure of otherwise undisclosed confidential information is made by one party to the other, such information shall be entitled to protection if identified as confidential at the time of initial disclosure and if a written notice with a summary of such disclosures is delivered to the receiving party within thirty (30) days of such disclosure. Any markings, stamps, or legends identifying confidential information shall not impose any obligations on either party inconsistent with this agreement. Any copies of the information made by the receiving party shall reproduce the confidential markings and any other legends contained on such information.
3.2 Both ACORDA and MAYO covenant and agree that they shall hold the Confidential Information they receive from the other party inviolate, keep it secret, and shall not use any such Confidential Information, except as provided in Article 4 below. The foregoing restrictions on disclosure of Confidential Information shall not apply to any information that properly comes into the public domain through no action of the other party or its agents or was already known by the other party as evidenced by its that partys written records. Each party may use its own discretion to disclose information that was independently developed by that party.
3.3 Confidential Information shall not be afforded the protection of this Option Agreement if, on the date of signing this Option Agreement, such information is or later becomes:
a) developed by the Recipient independently of the disclosed proprietary information of the other party, and reasonable written documentation exists to demonstrate such development; or
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b) rightfully obtained without restriction by the Recipient from any third party who is not restricted from making such disclosure by any direct or indirect obligation of confidentiality to the other party herein; or
c) publicly available other than through the fault of the Recipient; or
d) known to the Recipient at the time of its disclosure by the other party hereto, and reasonable written documentation exists to demonstrate such knowledge.
e) subject to disclosure under a facially valid court order, warrant, or subpoena, but only if the Recipient first gives the other party immediate oral and written notice of the court order, warrant, or subpoena to permit that party to take appropriate legal action in the circumstances.
3.4 ACORDA shall not disclose, provide or otherwise make the Technology or the Confidential Information available to any person or entity other than employees, consultants, advisors, or agents of ACORDA that have signed secrecy agreements at least as restrictive as the provisions of this Option Agreement. Before the Confidential Information or Technology is made available to any person directly responsible for the evaluation of the Technology for licensure, ACORDA will notify the person of the obligations of confidentiality contained in this Option Agreement and obtain an agreement from that person to abide by said obligations.
3.5 The obligations of confidentiality stated in 3.1 and 3.2 shall survive the termination or expiration of this Option Agreement for five (5) years.
Article 4. Authorized Use
4.1 During the term of this Option Agreement, ACORDA shall use the Technology and the Confidential Information only for the purpose of evaluating the Technology both in the laboratory and in commercial assessments. Notwithstanding the above, the ACORDA may disclose confidential Information of MAYO (1) to their legal representative and employees, to Affiliates, to legal representatives and employees of Affiliates, to the extent such disclosure is reasonably necessary to achieve the purposes of this Contract, and provided such representative and employees are covered by obligations of confidentiality with respect to such information no less stringent than those set forth herein; (ii) In connection with the filing and support of patent applications; or (iii) as required by law or to comply with applicable governmental regulations or court order or otherwise submit information to tax or other governmental authorities, including the FDA and its foreign counterparts; provided that if the ACORDA is required to make any such disclosure of MAYOs confidential information, other than pursuant to a confidentiality agreement, it will give reasonable advance notice to MAYO of such disclosure and save to the extent inappropriate in the case of patent applications, will use its reasonable efforts to secure confidential treatment of such information prior to its disclosure and disclose only the minimum necessary to comply with such requirements.
4.2 ACORDA and MAYO shall not use, expressly or by implication, any trademark or trade name of the other party, or any contraction, abbreviation, simulation or adaptation thereof, or the name of any of the other partys staff in any news, publicity release, policy recommendation, advertising or any commercial communication without the express written approval of the other party; provided, however, once a public announcement has been approved, further approvals need not be obtained for further announcement which are not materially different from an earlier approved announcement. The provisions of this Section 4.2 shall survive the Termination or expiration of this Option Agreement.
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Article 5. Termination
5.1 Should ACORDA, on or before the expiration of the option granted in 2.1 above, decide to exercise its option and execute the License Agreement, the terms of this Option Agreement will be superseded by the terms of the License Agreement at the time the License Agreement is executed by both parties and becomes effective.
5.2 Should ACORDA, on or before the expiration of the option granted in 2.1 above, decide not to license the Technology, ACORDA may terminate this Option Agreement by providing written notice of its decision to MAYO. Furthermore, Section 2.2 of this Option Agreement remains enforceable subsequent to any termination of this Option Agreement by ACORDA, subject to the terms and conditions of the Sponsored Research Agreement.
5.3 Following nine (9) months after the Effective Date of this Option Agreement, ACORDA shall have the right to terminate its support of the Sponsored Research with ninety (90) days notice; provided ACORDA shall be obligated to pay to MAYO the salary of one (1) technician until the third anniversary of the Effective Date of the Option Agreement, unless MAYO receives contract or grant funds from an external source to support said technician. Should ACORDA terminate the Sponsored Research Mayo agrees to use best efforts to find other sources of funding for the technical salary.
Article 6. General
6.1 ACORDA may not assign or subcontract any of its obligations or rights under this Option Agreement without MAYOs prior, express, written consent, which consent may not be unreasonably withheld, except that ACORDA may assign its rights and obligations under this Option Agreement without such consent to an affiliate wholly-owned or majority-owned or controlled by ACORDA, or to any entity that acquires substantially all of the assets of ACORDA, or entities to which ACORDA has assigned all or substantially all of its assets relating to the Option Agreement whether by merger, acquisition, sale, operation of law, or otherwise. Mayo, however, may object to such assignment of rights under this Option Agreement if ACORDA proposes to assign its rights to an entity whose image, reputation, or business goals are judged incompatible with MAYOs mission and reputation, in MAYOs reasonable Judgment.
6.2 This Option Agreement and its effects are subject to and shall be construed and enforced in accordance with the laws of the State of Minnesota except that no part of Minnesota law shall apply that directs the application of another jurisdictions law.
6.3 The failure of either party to insist at any time upon the strict observance or performance of any of the provisions of the Option Agreement, or to exercise any right or remedy as provided in this Option Agreement, shall not impair any such right or remedy and shall not be construed to be a waiver or relinquishment. Furthermore, no waiver of any provision of this Option Agreement by either party shall be construed as a waiver of any other provision or as a waiver of the same provision at any subsequent time.
6.4 This Option Agreement (including Exhibits A, B and C) constitutes the entire agreement between the parties and supersedes all prior or contemporaneous, oral and written agreements, proposals and discussions relating to the same subject matter. The Option Agreement may be amended only through a writing signed by each of the parties.
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6.5 Neither party shall disclose the terms of this Option Agreement to any third party, and neither party shall issue any press release or other statement to the media regarding the existence of the Option Agreement or its subject matter (if the other party is mentioned) without the prior written consent of the other party.
6.6 Both parties agree that execution of this Option Agreement may be effected by the receipt of facsimile signature pages.
IN WITNESS WHEREOF, each of the parties has caused this Option Agreement to be executed on its behalf by its duly authorized representative.
MAYO
FOUNDATION FOR MEDICAL
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ACORDA THERAPEUTICS, INC. |
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Signed: |
/s/ John H. Herrell |
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Signed: |
/s/ Ron Cohen, M.D. |
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Name: |
John H. Herrell |
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Name: |
Ron Cohen, M.D. |
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Title: |
Vice President |
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Title: |
President & CEO |
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Date: |
March 24, 1998 |
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3/20/98 |
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6
Exhibits A and B
to
Acorda/Mayo Option Agreement,
dated March 15, 1998
(Included as Exhibit A to License Agreement between
Acorda Therapeutics, Inc. and the
Mayo Foundation for Education and Research,
dated September 8, 2000)
EXHIBIT C
ACORDA/MAYO
TECHNOLOGY LICENSE CONTRACT TERM SHEET
Grant of Rights and Definitions
License: |
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Mayo Foundation for Medical Education and Research (MAYO) will grant to Acorda Therapeutics (ACORDA) an exclusive license, with the right to grant, offer for sale and authorize sublicenses, under the Licensed Patents to develop, make, have made, Import, Use, offer for sale, sell and otherwise exploit Licensed Product in the Territory. |
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Territory: |
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Worldwide (with specific regions to be defined in the final license for royalty accounting purposes). |
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Field of Use: |
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Use in the prevention, mitigation and/or treatment of nervous system disorders, diseases or injuries including, without limitation, pain. |
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Licensed Technology: |
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Licensed Technology includes (i) the Licensed Patents, (ii) Project Know-How, and (iii) all patent applications disclosing any invention or other intellectual property developed by Dr. Moses Rodriguez and/or Dr. Larry Pease and owned in whole or in part by MAYO relating to humanized and non-humanized monoclonal antibodies and pooled IgM for use in the prevention, mitigation and/or treatment of nervous system disorders, diseases or injuries, including without limitation pain, or derivatives and analogs thereof, including without limitation compositions and methods of making and using thereof, excluding the Technology subject to the Option Agreement entered by ACORDA and MAYO October 1, 1995, as amended.
It is understood and agreed that any use of intellectual property outside of the field covered by the original option agreement entered by ACORDA and MAYO on October 1, 1995, shall be covered by this agreement as depicted in Exhibit D. |
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Licensed Patents: |
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Licensed Patents include (i) all patent applications (provisional or utility) filed with respect to inventions conceived or otherwise developed relating to humanized and non-humanized monoclonal antibodies and pooled IgM, or their derivatives or analogs, for use in the prevention, mitigation and/or treatment of nervous system disorders, diseases or injuries, including without limitation pain, and (ii) all divisions, |
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US FDA marketing approval of the second (2nd) therapeutic Licensed Product which is not a modification or extension of the first Licensed Product and has a therapeutic indication which is different from the first Licensed Product: $500,000.00 |
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Royalties: |
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It is understood and agreed that a higher royalty is only due for Licensed Product which is outside the field defined in the original option agreement entered by ACORDA and MAYO on October 1, 1995. ACORDA shall pay MAYO the greater of:
(i) a royalty of two percent (2%) of the net sales up to $400,000,000.00 of the Licensed Product sold by ACORDA in the Territory covered by a valid claim of an issued patent within the Licensed Patents which contains an awarded valid composition of matter claim in the country which such Licensed Product are sold, or
(ii) two and one-half, percent (2.5%) of the net sales greater than $400,000,000.00 of the Licensed Product sold by ACORDA in the Territory covered by a valid claim of an issued patent within the Licensed Patents which contains an awarded valid composition of matter claim the country which such Licensed Product are sold, or
(iii) a royalty of one percent (1%) of the net sales of the Licensed Product sold by ACORDA in the Territory covered by a pending patent within the Licensed Patents containing a pending composition of matter claim in the country which such Licensed Product are sold.
If the issued patents contain only awarded valid utility claims the parties agree to negotiate in good faith royalty rates for the sale of Licensed Product which reflect customary royalties for intellectual property of the type, degree of proprietary protection and value mutually agreed to by MAYO and ACORDA. |
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Royalties to Third Parties: |
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In the event that in connection with its sale of Licensed Product, Acorda pays a third party royalties or other amounts to make, use or sell Licensed Product or to avoid or settle a claim of infringement of the intellectual property rights of such third party, Acorda may offset such amounts against up to 50% of the amounts due, Mayo; provided, however, in no event shall Mayo receive less than 0.50% of the net sales of Licensed Product sold by Acorda and its affiliates. |
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Sublicense Royalties: |
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ACORDA will pay MAYO twenty-five percent (25%) of the royalty received by ACORDA from sublicensees with respect to the sale of Licensed Product for use in applications which ACORDA decides, in its business judgment, not to commercialize. MAYO shall not be entitled to any share of amounts received by ACORDA from sublicensees for equity, debt, research and development, performance based milestones, the license or sublicense of any intellectual property other than the Licensed Patents, products other than the Licensed Product, or reimbursement for patent or other expenses. |
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Combination Product Royalties: |
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In the event that an Amended Licensed Product is sold in combination with another product which is not a Licensed Product, the amount paid to MAYO shall be based upon the proportion of the value of such combination products reasonably attributable, by mutual agreement of the parties, to the Licensed Patents. |
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Other Provisions |
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Due Diligence: |
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ACORDA will use reasonable efforts, consistent with its prudent business judgment, to develop and commercialize Licensed Product and obtain and maintain such approvals as may be necessary for the sale of products in the US and such other worldwide markets as ACORDA selects to commercialize such Licensed Product. ACORDA shall use reasonable efforts to develop a Licensed Product for Multiple Sclerosis (MS) as long as it remains technically and commercially feasible. If ACORDA decides in its business Judgment not to commercialize a Licensed Product for MS the parties agree to discuss returning the patent rights for MS to MAYO. |
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Patents: |
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MAYO shall own all of its inventions, discoveries and other developments. whether or not patentable, arising out of research carried out related to the Amended Licensed Patents. ACORDA shall own all of its inventions, discoveries and other developments, whether or not patentable, arising out of research carried out related to the Licensed Technology. Inventions or discoveries made Jointly by both MAYO and ACORDA shall be Jointly owned by both parties and, if patent applications are filed, patents shall be applied for on behalf of both parties. Rights held by MAYO in any inventions, including without limitation rights in and to patent applications and patents which may be obtained thereon, shall be deemed to be within the terms Licensed Patents and shall be subject to the license granted Acorda Therapeutics herein. |
21
Patent Prosecution: |
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ACORDA will be responsible, using patent counsel of its choice, for preparing, filing, prosecuting and maintaining patent applications and patents within the licensed patents. ACORDA will pay the costs incurred in connection with such activities, and reimburse MAYO for reasonable costs incurred in connection with such activities prior to the effective date of the license; fifty percent (50%) of all such amounts (including attorneys fees) shall be creditable against earned royalties due MAYO. At MAYOs request, ACORDA shall provide MAYO with reasonable documentation of such costs. MAYO and ACORDA will cooperate and consult with each other in the prosecution of the licensed patents. |
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Patent Enforcement: |
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In the event of any infringement of the Licensed Patents or misappropriation of the Project Know-How, the parties shall consult to determine if they will Jointly bring action to terminate such infringement or misappropriation. Any recovery obtained by the parties in such an action shall be used first to reimburse the cost of such action and the remainder divided equally between the parties.
In the event that the parties fail to initiate such action within ninety (90) days of receiving notice of such infringement or misappropriation, ACORDA shall have the right, but not the obligation, to initiate suit to stop such infringement or misappropriation. Any recovery obtained by ACORDA in such an action shall be used first to reimburse the cost of such action, and the remainder shall be retained by ACORDA and treated as net sales of Licensed Product, subject to the royalty obligations to MAYO herein.
In the absense of an agreement to institute a suit jointly, and if ACORDA does not initiate such an action within a further ninety (90) days, MAYO may institute a suit for the infringement of the licensed patents, or opposition or interference with respect thereto, or any misappropriation of Project Know-How, or defend any declaratory judgment relating thereto. MAYO shall bear the entire cost of such litigation, including attorneys fees, and shall be entitled to retain the entire amount of any recovery by way of judgment, award, decree, arbitration, or settlement. ACORDA shall cooperate reasonably with MAYO, except financially, in such litigation. |
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Sublincenses: |
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Any sublicense granted by Acorda under the Licensed Technology shall remain in effect and be assigned to MAYO in the event this license terminates. |
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Assignment: |
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ACORDA may not assign the license without the consent of MAYO, which consent shall not be unreasonably withheld; provided, ACORDA may assign the license in connection with the sale or transfer of all or substantially all the rights and obligations of ACORDA relating to the Licensed Product, without the prior consent of MAYO. |
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Term: |
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The License shall terminate on a country-by country and Licensed Product by Licensed Product basis upon the expiration of the last to expire Licensed Patent in such country. ACORDA shall have the right to |
22
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terminate the license agreement with respect to any aspect of the Licensed Technology and/or any country, on ninety (90) days written notice. |
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Other: |
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The formal agreement will include other customary provisions to be agreed upon by the parties, including indemnification, royalty reporting, audit rights and the like. |
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Execution: |
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Both parties agree that execution of this License Term Sheet may be effected by the receipt of facsimile signature pages. |
MAYO
FOUNDATION FOR MEDICAL
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ACORDA THERAPEUTICS, INC. |
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Signed: |
/s/ John H. Herrell |
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Signed: |
/s/ Ron Cohen, M.D. |
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Name: |
John H. Herrell |
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Name: |
Ron Cohen, M.D. |
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Title: |
Vice President |
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Title: |
President & CEO |
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Date: |
March 24, 1998 |
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Data: |
3/20/98 |
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23
Exhibit C
to
License Agreement between
Acorda Therapeutics, Inc. and the
Mayo Foundation for Education and Research,
dated September 8, 2000
Exhibit C
Remvelination Monoclonal Antibody Cases
PCT/U.S.
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Title of Application |
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Date of
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US#5,591,629 |
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Monoclonal Antibodies Which Promote Central Nervous System Remyelination |
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4/29/94 |
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PCT/US 95/05262 |
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Monoclonal Antibodies Which Promote Central Nervous System Remyelination |
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4/27/95 |
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08/692,084 |
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Promotion of Central Nervous System Remyelination Using Monoclonal Antibodies |
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8/8/96 |
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08/779,784 |
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Promotion of Central Nervous System Remyelination Using Monoclonal Antibodies |
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1/7/97 |
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09/332,862 |
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Human IgM Antibodies, and Diagnostic and Therapeutic Uses Thereof Particularly in the Central Nervous System |
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5/28/99 |
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09/580,787 |
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Human IgM Antibodies, and Diagnostic and Therapeutic Uses Thereof Particularly in the Central Nervous System |
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5/30/00 |
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09/568,351 |
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Human IgM Antibodies, and Diagnostic and Therapeutic Uses Thereof Particularly in the Central Nervous System |
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5/10/00 |
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PCT/US 00/14902 |
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Human IgM Antibodies, and Diagnostic and Therapeutic Uses Thereof Particularly in the Central Nervous System |
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5/30/00 |
Exhibit D
to
License Agreement between
Acorda Therapeutics, Inc. and the
Mayo Foundation for Education and Research,
dated September 8, 2000
EXHIBIT D
MANDATORY MEDIATION AND BINDING ARBITRATION
1. NOTICE OF DISPUTE. Except to the extent otherwise expressly provided in Sections 5.3 and 5.4 of this Agreement, any dispute related to this Agreement between the Parties, including its formation, performance, or Termination, which cannot be resolved by the Parties themselves within thirty (30) days of written notice by one Party to the other of the existence of a dispute, may be referred by either of the parties to mandatory mediation and binding arbitration under the terms of this Exhibit. The Parties intend the mediation/arbitration procedure described in this Exhibit to substitute in all cases for litigation related to any such dispute, subject only to part 7, below, and this agreement to submit all such disputes to mandatory mediation and binding arbitration is irrevocable.
2. LIMITATION PERIOD. No demand for mediation/arbitration may be made regarding any claim more than one hundred eighty (180) days after written notice by one Party to the other of the existence of a dispute, regardless of any otherwise applicable statute of limitations.
3. MEDIATOR/ARBITRATOR. If the Parties cannot agree upon a single mediator/arbitrator within fourteen (14) days after written demand by either of them for mediation/arbitration, then a single mediator/arbitrator shall be chosen by the American Arbitration Association office in New York City, New York, within thirty (30) additional days after the fourteen (14) day period. The mediator/arbitrator shall be generally experienced in the legal and technical matters related to the dispute.
4. MEDIATION. Within thirty (30) days of the appointment of the mediator/arbitrator, the Parties must attend a mediation session at which the mediator/arbitrator personally shall attempt to guide the Parties to a settlement. Each Party may be represented by counsel at the mediation, but each Party must attend through an officer having authority to agree to a settlement at the mediation. The mediation session shall occur in New York City, New York, and shall extend no longer than a single day. Statements or offers made at the mediation session shall not be admissible in any later arbitration hearing.
5. ARBITRATION. If such mediation has not resulted in a mutually-executed settlement agreement (or withdrawal of claim) within five (5) business days after the date of mediation, then the Parties shall proceed to arbitration as described below. Such arbitration, which the Parties intend to be final and to substitute for litigation, shall occur in New York City, New York, and the arbitration results may be entered as a final judgment in any court with jurisdiction. The decision of the arbitrator shall be final and binding upon the Parties both as to law and fact.
(a) Initial Disclosures. Within twenty-one (21) days after the date of mediation, the Parties shall exchange written disclosures listing with reasonable specificity: (i) all exhibits expected to be used by the Party at arbitration, and complete copies of such exhibits, (ii) all witnesses expected to be called by the Party at arbitration, and (iii) the substance of
the testimony of each witness. Copies of such disclosures shall be sent to the arbitrator, No exhibit or witness may be called if the same does not appear on such disclosure, and no witness may testify as to matters not described in such disclosure, except for rebuttal testimony as may be permitted by the arbitrator.
(b) Discovery Period. Within fourteen (14) days after exchange of the disclosure notices, the Parties shall make specific discovery requests to the arbitrator, and within an additional fourteen (14) days the arbitrator shall issue to both parties a joint discovery order. The discovery period preceding the arbitration hearing shall not exceed sixty (60) days from the issuance of the discovery order by the arbitrator.
(c) Scope of Discovery. Discovery shall be limited to that ordered by the arbitrator as being reasonable and necessary, and in no case shall exceed the deposition of two (2) witnesses for each Party, and/or the exchange of more than a total of twenty-five (25) specific and non-compound interrogatories by each party, and/or two specific requests by each Party for the production of documents considered by the arbitrator to be reasonably relevant and not unduly burdensome.
(d) Hearing. The arbitration hearing, which shall be confidential to the parties and not open to the public, shall not exceed two (2) separate days, and shall be completed within thirty (30) days of the close of discovery. The arbitrator may admit any testimony or other evidence which the arbitrator decides is reasonably relevant to the issues of the arbitration, but excluding statements or offers made by either Party at the mediation session.
(e) Final Decision. The arbitrator shall issue a final written decision no later than sixty (60) days following the end of the arbitration hearing, stating findings as to law and fact. The decision shall be confidential to the Parties. The arbitrator shall be limited to determining and ordering the payment of actual and direct damages if any, and may order the payment of indirect, special, incidental, or consequential damages only where bad faith has been shown and/or to the extent required to fulfill any obligations under Article 8 of the Agreement. The arbitrator shall not order the payment of punitive or exemplary damages in any case.
6. COSTS AND FEES. Both Parties shall be responsible for their own costs and fees (including attorneys fees), and shall divide common costs and fees equally; however, if the arbitrator specifically finds bad faith on the Part of either Party, then the arbitrator may order a different division of costs and fees.
7. EQUITABLE RELIEF. Nothing in this Exhibit prohibits either Party from seeking equitable relief to protect its rights to the extent that irreparable harm may occur and damages would not be a sufficient remedy, except that neither Party shall seek to enjoin mediation/arbitration as described in this Exhibit.
(a) Specific Performance. Among the equitable remedies that a Party may seek under this part 7, either Party may petition a court for specific performance of the terms of this Exhibit, including following the failure of either Party without good cause to adhere to the time limits set out in this Exhibit. A Party securing an order for specific performance under this part 7(a) is entitled to recover costs and reasonable attorneys fees in connection with such petition for specific performance and any related hearings.
8. SURVIVAL. The rights and obligations of the Parties described in this Exhibit survive the Termination, expiration, non-renewal, or rescission of this Agreement.
9. GOVERNING RULES AND LAW. To the extent not inconsistent with the terms of this Exhibit, the mediation and arbitration are governed by the rules of the American Arbitration Association, the Minnesota Arbitration Act, and the Federal Arbitration Act (9 U.S.C s. 1 et seq.).
Exhibit E
to
License Agreement between
Acorda Therapeutics, Inc. and the
Mayo Foundation for Education and Research,
dated September 8, 2000
MATERIAL TRANSFER AGREEMENT
1. The Effective Date of this Material Transfer Agreement is .
2. The parties to this Agreement are:
(a) MAYO Foundation for Medical Education and Research, 200 First Street SW, Rochester, MN 55905-0001, hereinafter MAYO; and
(b)
hereinafter INSTITUTION.
3. The MATERIAL covered by this Agreement includes: {relevant Ab} , developed by Moses Rodriguez, M.D. and his colleagues at MAYO Rochester (MAYO files MMV-92-102 and MMV-97-055); (b) any related biological material or associated know-how and data received by INSTITUTION from MAYO; and (c) any progeny or unmodified derivatives produced from any of the foregoing by MAYO, its employees and/or agents. The MATERIAL covered by this Agreement is the subject of United States Patent No. 5,591,629, Application S.N. 08/236,520, filed April 19, 1994, entitled Monoclonal Antibodies Which Promote Central Nervous System Remyelination, and foreign counterparts and [list specific CIPs or patents} and other pending patent claims of MAYO and is subject to an exclusive worldwide license granted by MAYO to Acorda Therapeutics, Inc, (ACORDA) pursuant to a license agreement dated [insert date] for commercial exploitation of the MATERIAL under the foregoing patent rights (the MAYO/ACORDA license agreement) INSTITUION AND MAYO acknowledge that MAYO may only transfer the MATERIAL to INSTITUION under terms and conditions of a material transfer agreement which has been approved in advance by ACORDA.
4. The MATERIAL and any related information disclosed by MAYO will be kept confidential and not made available or disclosed by INSTITUTION to third parties or disclosed in any publication. The MATERIAL shall be used solely for research in the laboratory of (SCIENTIST) at INSTITUTION, such research to be limited to . MAYO and ACORDA shall be free, in their sole discretion, to distribute the MATERIAL to others and to use it for their own purposes.
5. INSTITUTION shall not distribute or release the MATERIAL to any person other than laboratory personnel under SCIENTISTs direct supervision who shall be made aware of the provisions of this agreement, including confidentiality and license of commercial rights to inventions, and who is bound by its terms. INSTITUTION shall ensure that no one will be allowed to take or send the MATERIAL to any other location, unless prior written permission is obtained from MAYO and ACORDA. This MATERIAL is made available for investigational use only in laboratory animals or in vitro experiments. INSTITUTION and SCIENTIST agree that the MATERIAL will not be used for any other purpose. Neither the MATERIAL nor any biological materials treated therewith will be used in human beings. INSTITUTION and SCIENTIST are specifically excluded from re-engineering or modifying the MATERIAL with the specific intent of designing around pending claims of United States and foreign patents.
6. This Agreement and the resulting transfer of MATERIAL constitute a license to use the MATERIAL solely for not-for-profit academic research purposes. INSTITUTION agrees that nothing herein shall be deemed a grant under any MAYO patents (either existing or future) or any rights to use the MATERIAL for any products or processes for profit-making or commercial purposes. The MATERIAL will not be used in research that is subject to consulting or licensing obligations to another institution, corporation or business entity unless prior written permission is obtained from both MAYO and ACORDA.
7. MAYO and INSTITUTION agree that all rights to sole MAYO inventions resulting from the use of the MATERIAL under this agreement, i.e. inventions made solely by MAYO faculty, staff, or students, shall be owned by MAYO; sole INSTITUTION inventions resulting from the use of the MATERIAL under this agreement, i .e. inventions made solely by the employees of INSTITUTION, shall be owned by INSTITUTION. All rights to joint inventions resulting from the use of the MATERIAL under this agreement, as determined under United States Patent Law, shall be owned jointly between INSTITUTION and the MAYO.
8. Should INSTITUTION or SCIENTIST create, either alone or with MAYO, any new and useful invention, discovery, process, improvement or other intellectual property conceived of, first reduced to practice, made or otherwise developed during the research, whether for the MATERIAL, related to the MATERIAL, or resulting in part from use of the MATERIAL, (an Invention) it hereby grants MAYO, and MAYOs licensee, ACORDA, the exclusive (even as to INSTITUTION and SCIENTIST) perpetual, worldwide, royalty-free license to develop, make, have made, use, import, export, lease, offer to sell, sell, have sold and otherwise exploit any and all products, processes or services making use of the invention for any and all commercial purposes and to grant, offer for sale and authorize sublicenses with respect to the right and license granted under this Section 8 to third parties, MAYO acknowledges and confirms that any license rights it may receive from INSTITUTION under this agreement shall be deemed part of the technology MAYO has licensed to ACORDA under the MAYO/ACORDA license agreement.
9. INSTITUTION shall have no rights in the MATERIAL other than as provided in this Agreement, and at the request of MAYO, INSTITUTION and/or SCIENTIST will return or destroy all unused MATERIAL.
10. SCIENTIST will inform MAYO and ACORDA in reasonable detail of all research results created by SCIENTIST and/or INSTITUTION related to the MATERIAL by personal written communication. INSTITUTION and/or SCIENTIST shall be free to use data and information from research results for any academic and non-commercial purpose, but will make proper acknowledgment of the work done by SCIENTIST, and agree to inform MAYO and ACORDA of any proposed public disclosure of research results at least one hundred twenty (120) days prior to such disclosure to permit MAYO and ACORDA to protect any proprietary information related thereto and to confirm that no information disclosed to INSTITUTION in confidence is included in such public disclosure. MAYO and ACORDA shall be free to use any and all research results for any purpose.
11. The MATERIAL is experimental in nature and it is provided WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED. MAYO MAKES NO REPRESENTATION OR
2
WARRANTY THAT THE USE OF THE MATERIAL WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY RIGHT.
12. In no event shall MAYO be liable for any use by INSTITUTION, its employees and/or agents of the MATERIAL or any loss, claim, damage or liability, of whatsoever kind or nature, which may arise from or in connection with this Agreement or the use, handling or storage of the MATERIAL. Furthermore, to the extent permitted by applicable law, INSTITUTION agrees to indemnify MAYO and any of its employees and hold it and them harmless from any action, claim, or liability, including, without limitation, liability for death, personal injury, or property damage, arising directly or indirectly from INSTITUTIONs possession, testing, screening, distribution or other use of the MATERIAL provided under this Agreement, and/or from INSTITUTIONs publication or distribution of the test reports, data, and other information relating to said MATERIAL.
13. INSTITUTION will use the MATERIAL in compliance with all laws and governmental regulations and guidelines applicable to the MATERIAL, and when the MATERIAL is used in the United States, INSTITUTION and SCIENTIST will comply with current NIH guidelines.
14. This Agreement shall be governed by the laws of Minnesota. It may be amended only in writing signed by both MAYO and INSTITUTION and specifically referencing this Agreement. Any proposed amendment must also be approved in advance in writing by ACORDA. Neither this Agreement nor any of INSTITUTIONs or SCIENTISTS rights or obligations under the Agreement may be assigned by INSTITUTION or SCIENTIST without the written consent of MAYO. ACORDA is a third party beneficiary of this Agreement and shall have the right to enforce its provisions. The failure of MAYO or ACORDA to insist at any time upon the strict observance or performance of any of the provisions of this Agreement, or to exercise any rights or remedy as provided in this Agreement, will not impair any such right or remedy and will not be construed to be a waiver or relinquishment of the right or remedy.
3
4
Exhibit 10.25
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
June 1, 2005
RE: September 8, 2000 License Agreement between Acorda Therapeutics, Inc. and The Mayo Foundation for Medical Education and Research (the License Agreement)
This Letter of Agreement (the Letter Agreement) constitutes the agreement contemplated by Acorda Therapeutics, Inc. (Acorda) and Mayo Foundation for Medical Education and Research (Mayo) (collectively, the Parties) in the September 30, 2004 letter signed by Rick Colvin and Jane Wasman with respect to Mayos and Dr. Moses Rodriguez grant application to the Hilton Foundation.
Mayo proposes to enter into an agreement with the University of Minnesota (the University) under which the University may provide services for various research programs at Mayo, which agreement is attached hereto as Exhibit A. This Letter Agreement relates solely to the work plans (present and future) under the agreement for the development of rHIgM22 (the Antibody) within the Field (hereinafter, Antibody Services Agreement). The work to be performed pursuant to the Antibody Services Agreement shall be funded largely by a three-year grant (the Hilton Foundation Grant) received by Mayo and Dr. Rodriguez pursuant to the grant application referenced above.
The parties hereby agree as follows:
1. Grant : Acorda hereby grants to Mayo (to the extent Mayo has not already retained a right to use), the University, and any other third parties conducting work under the Antibody Services Agreement a non-exclusive license to use the Antibody for development within the Field for noncommercial purposes pursuant to the Hilton Foundation Grant during the term of the Hilton Foundation Grant.
2. Project Steering Committee : Acorda shall be allowed to attend and participate in the two in-person meetings of the Project Steering Committee held each year as established in the Antibody Services Agreement. In addition, Mayo agrees that the Mayo co-chair shall provide Acorda with quarterly updates regarding the work being planned or performed pursuant to the Antibody Services Agreement and shall timely seek Acordas input related to such work. Mayo also shall provide Acorda with the timely opportunity to review and comment on all future workplans that are contemplated pursuant to the Antibody Services Agreement.
3. Indemnification : The parties agree that, to the extent not already provided for by Section 8.2(a) of the September 8, 2000 License Agreement between Mayo and Acorda, Mayo shall defend, indemnify and hold Acorda and its affiliates and Sublicensees and their respective directors, officers and employees, harmless from and against any and all third party Claims arising out of or resulting from the administration of a product to a human subject(s) and/or other clinical activities (including activities preparatory to such clinical activities or the use of the results therefrom) arising out of or relating to the Antibody Services Agreement.
4. Publication : Mayo shall provide Acorda with the same rights to review, comment on and consent or object to any manuscripts, abstracts, posters, presentations or other potential publications (Publications) arising out of or relating to the Antibody Services Agreement or the work performed thereunder as are provided to Mayo in the Antibody Services
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Agreement, including the same amount of time for such review. Mayo shall forward to Acorda for Acordas review, comment and consent all potential Publications as soon as Mayo either drafts a Publication or receives one for review from the University.
5. Intellectual Property and Confirmation of License Agreement : The parties acknowledge that the work performed by Mayo under the Hilton Foundation Grant is being performed subject to and pursuant to Sections 2.1 and 2.2 of the License Agreement and any rights granted are solely for the Antibody in the Field. Mayo hereby grants Acorda a non-exclusive, worldwide, royalty-free license, limited to the Antibody in the Field, to any Inventions (as defined in the Antibody Services Agreement) developed by the University or any third party and owned by Mayo pursuant to the Antibody Services Agreement. To the extent Acorda does not have a license under the License Agreement for the work performed by Mayo under the Hilton Foundation Grant, including the Antibody Services Agreement, Mayo grants a non-exclusive, royalty-free license to Licensed Technology for the Antibody in the Field. Mayo and Acorda acknowledge that the License Agreement is in full force and effect.
6. Public Announcements : The Parties confirm that all public announcements relating to the Antibody Services Agreement, the Hilton Foundation Grant and/or the work performed thereunder shall be subject to the provisions of Section 10.6 of the License Agreement.
7. Diligence : The Parties agree that Acordas obligations under Section 5.1 of the License Agreement shall be deemed satisfied in full through the end of the three-year term of the Hilton Foundation Grant in consideration for Acordas use of reasonable commercial efforts, consistent with its business judgment, to seek a partner to provide additional resources to help develop and commercialize Licensed Products during the term of the Hilton Foundation Grant.
8. [**]
9. Miscellaneous : All capitalized terms used in this Letter Agreement and not otherwise defined herein shall have the same meaning as assigned to them in the License Agreement. In the event of a conflict between the terms of the Letter Agreement and the License Agreement, unless otherwise expressly stated herein, the terms of the License Agreement shall govern.
Agreed by on behalf of Mayo Foundation for
|
Agreed by on behalf of Acorda
|
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By: |
/s/ Rick F. Colvin |
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By: |
/s/ Ron Cohen |
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Name: |
Rick F. Colvin |
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Name: |
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Title: |
Assistant Treasurer |
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Title: |
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
UNIVERSITY OF MINNESOTA
SERVICES AGREEMENT
THIS SERVICES AGREEMENT (the Agreement) is entered into effective as of June 20, 2005 (Effective Date), by and between the Regents of the University of Minnesota (the University), a Minnesota constitutional corporation, and Mayo Foundation for Medical Education and Research (Mayo), a Minnesota charitable corporation., each a Party and collectively Parties. This Agreement is entered into by the University through its University of Minnesota, Minnesota Molecular and Cellular Therapeutics Facility.
NOW, THEREFORE, the parties agree as follows:
The term of this Agreement shall expire five years from the Effective Date, unless terminated earlier as provided in section 4 or extended as may be mutually agreed upon in writing.
1
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
2
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
3
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
4
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
If to the University:
University
of Minnesota
Attn: Randall Tlachac
Program Director
Molecular and Cellular Therapeutics
1900 Fitch Avenue
St. Paul, MN 55108
Phone No.: 612-624-0765
Facsimile No.: 612-624-1777
E-mail: rtlachac@unm.edu
5
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
With a copy to:
University
of Minnesota
Office of the General Counsel
Attn: Transactional Law Services Group
360 McNamara Alumni Center
200 Oak Street S.E.
Minneapolis, MN 55455-2006
Facsimile No.: (612) 626-9624
E-mail: contracts@mail.ogc.umn.edu
If to Mayo:
Mayo
Foundation or Medical Education and Research
200 First Street SW
Rochester, MN 55905-0001
Attn: Office of Technology
Commercialization
Phone No.: 507-284-8878
Facsimile No.: 507-284-5410
IN WITNESS WHEREOF, the parties have entered into the Agreement as of the Effective Date.
Regents of the University of Minnesota |
Mayo Foundation for Medical
|
||||||||
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By: |
/s/ Mark S. Pauer |
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By: |
/s/ Rick F. Colvin |
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||||
Name: |
Mark S. Pauer |
Name: |
Rick F. Colvin |
||||||
Title: |
Asst VP for Research |
Title: |
Assistant Treasurer |
||||||
Date: |
6/28/05 |
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Date: |
6/16/05 |
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||||
6
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Workplan A
[***]
7
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
IN WITNESS WHEREOF, the parties have entered into this Workplan A under the Agreement as of the latter of the Effective Date or the date first written below.
Regents of the University of Minnesota |
Mayo Foundation for Medical Education |
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and Research |
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By: |
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/s/ Mark S. Paller |
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By: |
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/s/ Rick F. Colvin |
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Name: |
Mark S. Paller |
Name: |
Rick F. Colvin |
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Title: |
Assistant VP for Research |
Title: |
Assistant Treasurer |
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Date: |
June 28, 2005 |
Date: |
June 16, 2005 |
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1
Exhibit 10.26
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
ASSET PURCHASE AGREEMENT
by and between
ELAN PHARMACEUTICALS, INC.
and
ACORDA THERAPEUTICS, INC.
dated as of July 21, 2004
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
ASSET PURCHASE AGREEMENT
This Asset Purchase Agreement (this Agreement ) is made and entered into as of July 21, 2004, by and between Acorda Therapeutics, Inc., a Delaware corporation (the Acquiror ), and Elan Pharmaceuticals, Inc., a Delaware-corporation (EPI).
RECITALS
This Agreement sets forth the terms and conditions upon which the Acquiror is agreeing to purchase the Purchased Assets (as defined below) and assume the Assumed Liabilities (as defined below) from EPI, and EPI is agreeing to sell the Purchased Assets and transfer the Assumed Liabilities to the Acquiror.
AGREEMENT
In consideration of the premises and the mutual covenants and promises contained herein, and for other good and valuable consideration, the receipt and sufficiency of which hereby are acknowledged, the parties agree as follows:
Accountants means an accounting firm of national reputation (excluding each of the Acquirors and EPIs respective regular outside accounting firms) as may be mutually acceptable to the Acquiror and EPI; provided , however , that in the event that the Acquiror and EPI are unable to agree on such an accounting firm within ten (10) days, then the accounting firm shall be selected by lot.
Accounts Receivable means all trade accounts and notes receivable and other miscellaneous receivables, including those that are not evidenced by instruments or invoices, existing as of the Closing Date.
Acquiror has the meaning set forth in the preamble hereto.
Acquiror 2004 Gross Sales has the meaning set forth in Section 4.03(a)(i).
Acquiror Adverse Effect means an effect or condition that individually or when taken together with all other effects or conditions has had or would reasonably be expected to have more than an immaterial adverse effect (i) on the business, assets, Liabilities, results of operations or financial condition of the Acquiror, taken as a whole, other than any effect or condition relating (x) to the economy in general, or (y) in general to the pharmaceutical industry in which the Acquiror operates and not specifically relating to the Acquiror; provided , that such event, circumstance, effect or condition does not have a materially disproportionate effect on the business, assets, Liabilities, results of operations or financial condition of Acquiror, taken as a
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
whole; or (ii) on the ability of the Acquiror to perform its obligations under this Agreement and the Related Agreements or on the ability of the Acquiror to consummate the transactions contemplated hereby and thereby; provided , however , that the entry into the marketplace of a generic equivalent to any of the Products shall not be an Acquiror Adverse Effect.
Acquiror Disclosure Schedule has the meaning set forth in the preamble to Article VII.
Acquiror Governmental Consents has the meaning set forth in Section 7.03(a).
Acquiror Indemnitees has the meaning set forth-in Section 11.02(a).
Acquiror Insurance Policies has the meaning set forth in Section 7.08.
Acquiror Third Party Consents has the meaning set forth in Section 7.03(b).
Action or Proceeding means any action, suit, proceeding, arbitration, Order, inquiry, hearing, assessment with respect to fines or penalties or litigation (whether civil, criminal, administrative or investigative) commenced, brought, conducted or heard by or before, or otherwise involving, any Governmental or Regulatory Authority.
Activity Date has the meaning set forth in Section 8.05(d).
Administrative Fee means any administrative service fee paid to managed care organizations, pharmacy benefit managers, health maintenance organizations or other customers (including for the avoidance of doubt governmental organizations).
Affliate means, with respect to any Person, any other Person which Controls, is Controlled by or is under common Control with such Person.
Agreement has the meaning set forth in the preamble hereto.
Assignment and Assumption Agreement shall mean the Assignment and Assumption Agreement by and among EPI, the Acquiror and Novartis Pharma AG, dated as of the Closing Date, in substantially the form attached hereto as Exhibit G .
Assumed Contracts has the meaning set forth in Section 2.01(a).
Assumed Liabilities has the meaning set forth in Section 3.01(a).
Audit Termination Date has the meaning set forth in Section 4.02(c).
Bill of Sale means the Bill of Sale and Assignment and Assumption Agreement to be dated the Closing Date conveying the Purchased Assets from EPI to the Acquiror and providing for the assignment to and assumption of the Assumed Liabilities by the Acquiror, substantially in the form attached hereto as Exhibit A .
Books and Records means all books, records, files and documents (including financial, sales, pricing, promotional, regulatory, pharmacovigilance, research and development
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
and expense records, customer lists, customer (including government) Product utilization and rebate or chargeback records (including invoices from customers), best price (as defined under the Social Security Act, 42 U.S.C. § 1396r-8(c)(1)(C)) and average manufacturer price (as defined under the Social Security Act, 42 U.S.C. § 1396r-8(k)(1)) data, credit and collection records and miscellaneous records with respect to customers and supply sources correspondence and, to the extent not originals, true and complete copies of all files relating to the filing, prosecution, issuance, maintenance, enforcement or defense of any Patents, Patent applications, Trademarks, Copyrights or other intellectual property rights, including written third party correspondence, records and documents related to research and pre-clinical and clinical testing and studies for the Product conducted by or on behalf of EPI or its Affiliates) in all forms, including electronic, in which they are stored or maintained, and all data and information included therein, in each case that are licensed, owned or controlled by or otherwise in the possession of EPI or any of its Affiliates.
Business means the research, development, exploitation, licensing, distribution, marketing, sale, promotion, importation and use of the Products in the Territory.
Business Day means a day other than Saturday, Sunday or any day on which commercial banks located in New York are authorized or obligated by Law to close.
Charter Documents means, with respect to a Person, the certificate of incorporation, bylaws or other similar governing instruments and organizational documents of such Person.
Closing has the meaning set forth in Section 5.01.
Closing Consideration has the meaning set forth in Section 4.01(a).
Closing Date has the meaning set forth in Section 5.01.
Closing Date Inventory Value means the value of all Inventory as of the Closing Date, such value determined pursuant to the methods described on Schedule 1.01(a) of the Elan Disclosure Schedule.
Closing Date Inventory Value Adjustment means the Closing Date Inventory Value minus the Estimated Closing Date Inventory Value.
Closing Date Inventory Value Statement has the meaning set forth in Section 4.08(a).
Code means the Internal Revenue Code of 1986, as amended.
Confidential Information has the meaning set forth in Section 8.04(b).
Confidentiality Agreement has the meaning set forth in Section 8.04(f).
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Contracts means any and all binding commitments, contracts, purchase orders, leases, licenses, easements, commitments, arrangements, undertakings or other agreements, whether written or oral.
Control means:
(a) ownership (directly or indirectly) of at least fifty percent (50%) of the shares of stock entitled to vote for the election of directors in the case of a company or corporation;
(b) the ability (directly or indirectly) otherwise to direct and control the actions of a Person.
Copyrights means (a) all copyrights in the Territory (including copyrights in any content, package inserts, marketing or promotional material, labeling information or other text provided to consumers), whether registered or unregistered; (b) any registrations, and applications therefor; (c) all rights and priorities to copyrights in the Territory afforded under any international treaty or convention; (d) all copyright extensions and renewals in the Territory; (e) any rights similar to the foregoing in the Territory, including moral rights; (f) all proceeds of the foregoing, including licenses, royalties, income and payments; and (g) the right to sue for past, present and future infringements of any of the foregoing and all proceeds of such suits, provided that any such proceeds of suit shall be proportionately divided among EPI and the Acquiror based on the duration of infringing activity prior to and following the Closing if EPI agrees prior to the commencement of such suit to bear its pro rata share of the costs of prosecuting the claim relating to such activity calculated on the same basis.
Corporate Names has the meaning set forth in Section 8.09(b).
Damages has the meaning set forth in Section 11.02(a).
Default means (a) a breach, default or violation, (b) the occurrence of an event that with or without the passage of time or the giving of notice, or both, would constitute a breach, default or violation or cause an Encumbrance to arise; or (c) with respect to any Contract, the occurrence of an event that with or without the passage of time or the giving of notice, or both, would give rise to a right of termination, renegotiation or acceleration or a right to receive Damages or a payment of penalties.
Domain Name Assignment Agreement means the Domain Name Assignment Agreement to be dated as of the Closing Date by and between the Acquiror and EPI, substantially in the form attached hereto as Exhibit B .
Domain Names means the domain names set forth on Schedule 1.01(b) of the Elan Disclosure Schedule, and all associated portals and websites solely associated with the Products.
Due Date has the meaning set forth in Section 4.02(b).
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Elan Companies Proceeding means any Action or Proceeding commenced by or against any of EPI or any of its Affiliates or officers or directors prior to the date of this Agreement.
Elan Disclosure Schedule has the meaning set forth in the preamble to Article VI.
Elan Governmental Consents has the meaning set forth in Section 6.03(a).
Elan Third Party Consents has the meaning set forth in Section 6.03(b).
Eligible Claim has the meaning set forth in Section 11.03(a).
Encumbrance means any mortgage, pledge, assessment, security interest, deed of trust, lease, lien, levy, license, restriction on transferability, defect in title, charge or other encumbrance of any kind, or any conditional sale or title retention agreement or other agreement to give any of the foregoing in the future.
EPI has the meaning set forth in the preamble.
EPI Contract means any Contract to which EPI or any of its Affiliates is a party or by which EPI or any of its Affiliates is bound or benefited, or under which EPI or any of its Affiliates has any rights.
EPI Indemnitees has the meaning set forth in Section 11.02(b).
EPI Royalty Term has the meaning set forth in Section 4.02(a)(i).
Estimated Closing Date Inventory Value means the value of all Inventory as of the Closing Date, valued in accordance with the definition of Closing Date Inventory Value in EPIs reasonable and good faith estimation.
Excluded Assets has the meaning set forth in Section 2.02.
Excluded Books and Records means all Books and Records related to (i) human resources and any other employee-related files and records, (ii) financial and accounting records, (iii) any items set forth on Schedule 1.01(c) of the Elan Disclosure Schedule, (iv) any tax files, documents, instruments, papers, books or records, and (v) the filing, prosecution, issuance, maintenance, enforcement or defense of any Patents, Patent applications, Trademarks, Copyrights or other intellectual property rights comprising Excluded intellectual Property.
Excluded Intellectual Property means any intellectual property rights, including any patent, copyright, trademark, trade secret or other proprietary rights, that are owned or controlled by EPI or any of its Affiliates, relating to technology that is (a) contained in the Products and other pharmaceutical products owned or controlled by EPI or any of its Affiliates, including SODAS technology used in Zanaflex Capsules, or (b) used in the manufacture of Zanaflex Capsules, but in no event shall the Excluded Intellectual Property include any of the Purchased Intellectual Property or Product Trademarks.
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Excluded Liabilities has the meaning set forth in Section 3.01(b).
Expiration Date has the meaning set forth in Section 11.01(a).
Final Milestone Payment Date has the meaning set forth in Section 4.03(b).
FDA means the United States Food and Drug Administration or any successor thereto.
FDA Act means the U.S. Federal Food, Drug and Cosmetic Act of 1938, as it may be superseded or amended from time to time, and the related rules, regulations, guidelines, guidances and requirements of the FDA as may be in effect from time to time.
Final Milestone Payment Date has the meaning set forth in Section 4.03(b).
FSS has the meaning set forth in Section 8.05(d).
Governmental or Regulatory Authority means the United States, Canada, any Member State of the European Union, any other country, any supranational organization, any state, province, county, city or other political subdivision of any of the foregoing or any court, tribunal, arbitrator, authority, agency, commission, ministry, official or other instrumentality of any of the foregoing.
Governmental Permits means all permits, licenses, registrations, certificates of occupancy, approvals and other authorizations of any Governmental or Regulatory Authority, including INDs, NDAs and other approvals of or registrations with any Governmental or Regulatory Authority for the investigation, sale, distribution and/or marketing of products.
Gross Sales means the gross amount invoiced on sales by the Acquiror, its Affiliates and marketing, promotion and distribution partners to independent, third party customers in bona fide, arms-length transactions.
Improvement means any present and future invention, improvement, discovery, modification or other development relating to a Product, including any new uses or formulations for a Product, and all intellectual property rights in any of the foregoing, that are owned by EPI or any Affiliate at any time after the Closing; provided , that the parties acknowledge and agree that, subject to the obligations set forth in the Supply Agreement, neither EPI nor any of its Affiliates shall have any obligation after the Closing to conduct any research or development relating to the Products.
IND means (a) an Investigational New Drug Application, as defined in the FDA Act, as amended, and the regulations promulgated thereunder (C.F.R. Parts 312-312.38), which is required to be filed (except under circumstances as described in such regulations promulgated thereunder) with the FDA before beginning clinical testing of a product in human subjects, or any successor application or procedure, and (b) all supplements and amendments that may be filed with respect to he foregoing.
Indemnification Claim Notice has the meaning set forth in Section 11.02(c).
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Indemnified Party has the meaning set forth in Section 11.02(c).
Indemnitees has the meaning set forth in Section 11.02(c).
Interim Services Agreement shall mean the Interim Services Agreement by and between EPI and the Acquiror, dated as of the Closing Date, in substantially the form attached hereto as Exhibit C .
Inventory means all inventory of finished Products (including samples) having a shelf life of greater than 12 months from the Closing Date, together with the inventory of finished Products having a shelf life of less than 12 months from the Closing Date described on Schedule 1.01(a) of the Elan Disclosure Schedule.
Know-How means any proprietary or nonproprietary information directly related to the manufacture, preparation, development (including research, both pre-clinical and clinical), promotion, exploitation, marketing, use, sale or other commercialization of a product, including related to regulatory matters.
Knowledge of a particular fact or other matter means: (i) with respect to any individual: (A) the actual knowledge of such individual concerning such fact or other matter; and (B) the knowledge that a prudent individual would be expected to discover or otherwise become aware of in the course of conducting a reasonable investigation concerning the existence of such fact or other matter, and (ii) with respect to EPI or the Acquiror, the Knowledge concerning such fact or other matter of (1) the officers of such Person, (2) the directors of such Person, and (3) the senior managers of such Person with responsibility for, or supervision of, the relevant matters; provided that under no circumstances shall Knowledge of EPI include any knowledge not actually known to such persons but imputed to such persons or EPI due to its relationship with Novartis or its representatives; and provided, further, that none of such persons shall have any obligation as a result of entering into (or any provision of) this Agreement, the Supply Agreement or any Related Agreement to make any inquiries of Novartis or its representatives regarding any matter.
Labeling has the meaning set forth in Section 201(m) of the FDA Act, 21 U.S.C. § 321(m) and any related rule, regulation, guideline or guidance of the FDA, and shall include the applicable Products label, packaging and package inserts accompanying such Products, and any other written, printed, or graphic materials accompanying such Products, including patient instructions or patient indication guides and the NDC numbers relating to the Products.
Law means any federal, state, local or foreign law, statute or ordinance, or any rule, regulation or regulatory requirement promulgated by any Governmental or Regulatory Authority.
Liability means any direct or indirect liability, obligation, claim, guarantee or commitment of any kind or nature (whether known or unknown, asserted or unasserted, absolute or contingent, accrued or unaccrued, liquidated or unliquidated or due or to become due), including any liability for Taxes.
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Material Adverse Effect means an event, circumstance, effect or condition that individually of when taken together with all other events, circumstances, effects or conditions has bad or would reasonably be expected to have more than an immaterial adverse effect (i) on the business, assets, Liabilities, results of operations or financial condition of the Business, other than any event, circumstance, effect or condition relating primarily (x) to the economy in general, provided , that such event, circumstance, effect or condition does not have a materially disproportionate effect on the business, assets, Liabilities, results of operations or financial condition of the Business, or (y) in general to the pharmaceutical industry in which the Business operates and not specifically relating to the Products or the Business, provided, that such event, circumstance, effect or condition does not have a materially disproportionate effect on the business, assets, Liabilities, results of operations or financial condition of the Business; (ii) on any of the Products or the Purchased Assets; or (iii) on the ability of EPI to perform its obligations under this Agreement, the Supply Agreement or any Related Agreement or on the ability of EPI to consummate the transactions contemplated hereby and thereby; provided , however , that the entry into the marketplace of a generic equivalent to any of the Products shall not be a Material Adverse Effect.
Milestone Audit Termination Date has the meaning set forth in Section 4.03(b).
Milestone Payments has the meaning set forth in Section 4.03(a)(v).
Multi-Product Contract has the meaning set forth in Section 8.06.
NDA means a New Drug Application for any product, as appropriate, requesting permission to place a drug on the market in accordance with 21 U.S.C. § 355 and 21 C.F.R. Part 314, and all supplements or amendments filed pursuant to the requirements of the FDA, including all documents, data and other information concerning a product which are reasonably necessary for FDA approval to market a product in the United States, and all correspondence with the FDA relating to the foregoing.
Net Sales shall mean Gross Sales less customs duties or other taxes (excluding income or corporation tax), returns (including returns in connection with rejections and recalls), Administrative Fees, rebates, chargebacks, allowances for bad debt and discounts, in each case related to such sales.
Non-Assignable Contract has the meaning set forth in Section 2.04(a).
Notice means any notice given in accordance with the terms of Section 13.01 of this Agreement.
Notice of Objection has the meaning set forth in Section 4.08(b).
Novartis License Agreement means that certain license agreement dated as of April 17th, 1991, as amended, by and between Novartis Pharma AG (together with its Affiliates, Novartis ), as successor to Sandoz Pharma Ltd., and EPI, as successor to Athena Neurosciences, Inc.
Novartis Royalty Term has the meaning set forth in Section 4.02(a)(i).
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Order means any writ, judgment, decree, injunction or similar order, including consent orders, of any Governmental or Regulatory Authority (in each such case whether temporary, preliminary or final).
Ordinary Course of Business means an action that is in compliance with applicable Laws and is consistent in nature, scope and magnitude with the past practices of EPI and its Affiliates with respect to the Business as conducted by EPI including any action necessary or desirable for EPI or its Affiliates to enforce its rights and perform its obligations under the Novartis License Agreement.
Patent Assignment Agreement means the Patent Assignment Agreement to be dated as of the Closing Date by and between the Acquiror and EPI, substantially in the form attached hereto as Exhibit D .
Patent Rights means solely in the Territory and relating to any Product, the rights conferred or represented by a Patent.
Patents means: (a) all patents and patent applications, including provisional patent applications; (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, substitutions, provisionals, converted provisionals, and continued prosecution applications; (c) any and all patents that have issued or in the future issue from the foregoing patent applications described in clauses (a) and (b), including utility models, petty patents and design Patents and certificates of invention; (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidation, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications described in clauses (a), (b) and (c); (e) all proceeds of the foregoing, including licenses, royalties, income and payments; and (f) the right to sue for past, present and future infringements of any of the foregoing and all proceeds of such suits, provided that any such proceeds of suit shall be proportionately divided among EPI and the Acquiror based on the duration of infringing activity prior to and following the Closing if EPI agrees prior to the commencement of such suit to bear its pro rata share of the costs of prosecuting the claim relating to such activity calculated on the same basis.
Permitted Encumbrance means, collectively, (a) liens for Taxes or assessments that are not delinquent and that do not individually or in the aggregate materially detract from the value or impair the use or operation of the property or asset affected thereby as currently used or operated, (b) mechanics, carriers, workmens, landlords or other like statutory liens arising or incurred in the ordinary course of business which are not yet delinquent and that do not individually or in the aggregate materially detract from the value or impair the use or operation of the property or asset affected thereby as currently used or operated, and (c) restrictions under zoning, building, fire, health, environmental and pollution control Laws that do not individually or in the aggregate materially detract from the value or impair the use or operation of the property or asset affected thereby as currently used or operated.
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Person means any natural person, corporation, general partnership, limited partnership, limited liability company, proprietorship, joint venture, other business organization, trust, entity, union, association or Governmental or Regulatory Authority.
Pre-Closing Tax Period means all taxable periods ending on or before the Closing Date and the portion ending on the Closing Date of any taxable period that includes (but does not end on) the Closing Date.
Product Books and Records shall mean all of the Books and Records relating exclusively to the Products or that are necessary for the conduct of the Business in the Territory, Including the Product Marketing Materials but excluding the Excluded Books and Records.
Product Copyrights means all Copyrights, set forth on Schedule 1.01(d) of the Elan Disclosure Schedule.
Product Know-How means all Know-How set forth on Schedule 1.01(e) of the Elan Disclosure Schedule, but in no event shall this definition of Product Know How include any Excluded Intellectual Property or any information properly in the public domain as of the Closing Date.
Product Marketing Materials means all of the advertising, promotional and training materials solely relating to the Products in the possession of EPI or its Affiliates as of the Closing Date.
Product Patent Rights means the Patents in the Territory set forth on Schedule 1.01(f) of the Elan Disclosure Schedule, and all Patent Rights associated with such Patents. Notwithstanding the foregoing, Product Patient Rights shall not include any inchoate inventions not yet reduced to practice, all of which, subject to the license granted pursuant to Section 2.02, shall remain the exclusive property of EPI.
Product Registrations means (i) the approvals or registrations which have been received by EPI before the Closing Date, for the investigation, sale, distribution and/or marketing of the Products in the Territory (including any NDAs or INDs), and (ii) all dossiers, reports, data and other written materials filed as part of such approvals or registrations, or maintained by EPI and relating to such approvals or registrations.
Products means Zanaflex Tablets and Zanaflex Capsules, along with any other pharmaceutical products containing the compound tizanidine as their active pharmaceutical ingredients to which EPI has ownership rights.
Product Trademark means the Trademarks in the Territory set forth on Schedule 1.01(g) of the Elan Disclosure Schedule.
Purchased Assets has the meaning set forth in Section 2.01.
Purchased Governmental Permits means all Governmental Permits necessary for the operation of the Business by EPI that are held in the name of EPI or any of its Affiliates.
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Purchased Intellectual Properly means the Product Copyrights, the Product Patent Rights, the Product Know-How and the Domain Names; provided that, notwithstanding anything to the contrary contained herein, in no event shall Purchased Intellectual Property include any Excluded Intellectual Property.
Rebates and Chargebacks Termination Date means the date that is ninety (90) days after the Closing Date.
Related Agreements means the Bill of Sale, the Assignment and Assumption Agreement, the Interim Services Agreement, the Patent Assignment Agreement, the Trademark License Agreement and the Domain Name Assignment Agreement.
Returns Termination Date means the date that is one hundred and eighty (180) days after the Closing Date.
Royalty Payments has the meaning set forth in Section 4.02(a).
Royalty Term has the meaning set forth in Section 4.02(a).
Subsidiary of a Person means any entity Controlled by that Person.
Supply Agreement means the Supply Agreement to be dated as of the Closing Date by and between the Acquiror and EPI or one or more of its Affiliates, substantially in the form at attached hereto as Exhibit E .
Taxes means all of the following in connection with the operation of the Business or the transactions contemplated hereby: (i) any net income, withholding, deduction, alternative or add-on minimum tax, gross income, gross receipts, sales, use, value added ad valorem, transfer, franchise, profits, license, excise, severance, stamp, occupation, premium, property, environmental or windfall profit tax, capital tax, customs duty or other tax, governmental fee or other like assessment, together with any interest, penalty or additional amount due, imposed by any governmental, regulatory or administrative entity or agency responsible for the imposition of any such tax (domestic or foreign); (ii) any Liability for the payment of any amounts of the type described in (i) as a result of being a member of any affiliated, consolidated, combined, unitary or other group for any taxable period; and (iii) any Liability for the payment of any amounts of the type described in (i)or (ii) as a result of any express or implied obligation to indemnify any other Person.
Termination Date has the meaning set forth in Section 12.01(b).
Territory means the United States of America, its territories and possessions and the Commonwealth of Puerto Rico.
Third Party Intellectual Property means any intellectual property rights, including any patent, copyright, trademark, trade secret or other proprietary rights, that are owned or controlled by any Person other than a party to this Agreement.
Third Party Claim has the meaning set forth in Section 11.02(d).
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Trademark License Agreement means the Trademark License Agreement to be dated as of the Closing Date by and between the Acquiror and EPI, substantially in the form attached hereto as Exhibit F .
Trademarks means: (a) all trademarks, trade names, trade dress, service marks, logos and designs, whether registered or unregistered; (b) all registrations and applications for any of the foregoing; (c) all extensions or renewals of any of the foregoing; (d) all of the goodwill connected with the use of and symbolized by the foregoing; (e) all proceeds of the foregoing, including licenses, royalties, income and payments; and (f) the right to sue for past, present and future infringements of any of the foregoing and all proceeds of such suits, provided that any such proceeds of suit shall be proportionately divided among EPI and the Acquiror based on the duration of infringing activity prior to and following the Closing if EPI agrees, prior to the commencement of such suit to bear its pro rata share of the costs of prosecuting the claim relating to such activity calculated on the same basis.
Trademark Purchase has the meaning set forth in Section 4.04.
Transfer Taxes has the meaning set forth in Section 4.06.
Zanaflex Capsules means pharmaceutical products containing tizanidine as their active pharmaceutical ingredients currently approved by the FDA pursuant to NDA No. 21-447 to be marketed in the Territory under the trademark Zanaflex.
Zanaflex Tablets means pharmaceutical products containing tizanidine as their active pharmaceutical ingredients currently approved by the FDA pursuant to NDA No. 20-397 and marketed in the Territory under the trademark Zanaflex.
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
provided , however , that notwithstanding anything to the contrary contained herein, EPI shall not be required to transfer physical possession of any Purchased Assets to the Acquiror to the extent any of such Purchased Assets are necessary for EPI to perform its obligations under the Interim Services Agreement (it being understood that (i) EPI will transfer physical possession of such Purchased Assets to the Acquiror as soon as is practicable after such obligations aim fully performed, and (ii) as long as EPI retains physical possession of any Purchased Assets, EPI shall, upon request of the Acquiror, provide the Acquiror with immediate access to and copies of such Purchased Assets (at Acquirors expense and provided that such access does not unreasonably interfere with the business or operations of EPI or its Affiliates).
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
EPI hereby grants to the Acquiror an exclusive, perpetual, royalty-free license, with the right to sublicense, to use (i) the Excluded Intellectual Property (including any inchoate inventions not yet reduced to practice), (ii) any other intellectual property owned by EPI or any of its Affiliates that is necessary to conduct the Business, and (iii) any Improvements to the intellectual property described in clauses, (i) and (ii) of this sentence solely for the purposes of importing Products into the Territory and using, modifying, exploiting, researching, distributing, developing, marketing, selling, offering for sale and otherwise commercializing Products in the Territory. In addition, at the Closing, EPI and the Acquiror will enter into the Trademark License Agreement.
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
For greater clarity, the parties acknowledge and agree that, notwithstanding anything to the contrary contained in this Section 3.01(a), if any Liabilities that arise from any event, circumstance or condition occurring after the Closing relate to or in any way involve any Products that have been sold, the Acquiror shall only assume those Liabilities arising from those Products sold directly at any time after the Closing by the Acquiror (or its Affiliates, sublicensees and marketing, promotion or distribution partners), and EPI shall retain all Liabilities arising from those Products sold directly at any time prior to he Closing by EPI (or its Affiliates, sublicensees and marketing, promotion or distribution partners).
15
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
16
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
The Closing Consideration shall be exclusive of any value added tax which, if urged, shall be payable by Acquirer.
17
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
18
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
19
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
20
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
21
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
EPI represents and warrants to the Acquiror that each statement set forth in each of the sections and subsections of this Article VI (each such statement being a representation and warranty of the Company) is accurate and complete as of the date hereof (except as to certain representations and warranties which expressly speak as of a different date certain, which shall be accurate and complete as of such date), except as set forth in any disclosure schedule delivered to the Acquiror by EPI on the date of this Agreement corresponding to the particular section of subsection of this Article VI in which such representation and warranty appears (it being understood, however, that a disclosure in a particular disclosure schedule will also be deemed to qualify a representation and warranty that does not appear in the corresponding section or subsection of this, Article VI if such disclosure reasonably relates to such representation and warranty) (All disclosure schedules delivered to the Acquiror by EPI on the date of this Agreement being collectively referred to as the Elan Disclosure Schedule ).
22
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
23
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
24
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
25
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
26
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
27
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
The Acquiror represents and warrants to EPI as of the date hereof (except as to certain presentations and warranties which expressly speak as of a different date certain, which shall be accurate and complete as of such date), subject to such exceptions as are disclosed in the disclosure schedule supplied by the Acquiror to EPI and dated as of the date hereof (the Acquiror Disclosure Schedule ), as follows:
28
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
(b) Schedule 7.03(b) of the Acquiror Disclosure Schedule sets forth a complete and accurate list (the Acquiror Third Party Consents ) of all consents, waivers, approvals, or authorizations of, or notices to, any Person (other than a Governmental or Regulatory Authority) that are required by or with respect to the Acquiror in connection with the execution and delivery of this Agreement, the Supply Agreement and the Related Agreements by the Acquirer, the consummation of the transactions contemplated hereby and thereby or the performance of its obligations hereunder and thereunder, except for those consents, waivers, approvals, authorizations or notices which a failure to obtain or make would not have an Acquiror Adverse Effect.
Section 7.04. Non-Contravention . The execution and delivery by the Acquiror of This Agreement, the Supply Agreement and the Related Agreements to which it is a party, does not, and the performance by it of its obligations under this Agreement, the Supply Agreement and such related Agreements and the consummation of the transactions contemplated hereby and thereby will not:
(a) conflict with or result in a violation or breach of any of the terms, conditions or provisions of the Charter Documents of the Acquirer;
(b) assuming the receipt of all Acquiror Governmental Consents, conflict with or result in a violation or breach of any term or provision of any Law applicable to the Acquiror; or
(c) conflict with or result in a Default under any Contract to which the Acquiror is a party or by which the Acquirer or any of its assets are bound, except as would not have an Acquiror Adverse Effect.
Section 7.05. Litigation . There are no Orders, Actions or Proceedings pending, or the Knowledge of the Acquiror, threatened, against the Acquiror in connection with or relating to (i) this Agreement, the Supply Agreement or any Related Agreement, or (ii) the transactions contemplated by this Agreement, the Supply Agreement or any Related Agreement.
Section 7.06. Financial Capability . As of the date of this Agreement, the Acquiror and its Subsidiaries have at least $15 million of cash, cash equivalents and marketable securities with maturity of less than one year. Prior to the Closing, the Acquiror shall not permit such assets to fall below $15 million unless otherwise agreed to in writing by EPI.
Section 7.07. Insurance . The Acquiror and each of its Affiliates that will be involved in the conduct of the Business maintain insurance policies covering their respective assets, business, equipment, properties, operations, employees, officers and directors, including product liability insurance (collectively, the Acquiror Insurance Policies ), which are of the type and amounts customarily carried by Persons conducting businesses similar to those of the Acquiror and its, Affiliates, and each of the Acquiror and its Affiliates, as the case may be, will maintain such Acquiror Insurance Policies for at least three (3) years following the Closing. As
29
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
of the date of this Agreement, the Acquirer does not know of any threatened termination of, or material premium increase with respect to, any Acquiror Insurance Policies.
Section 7.08. No Other Warranties . EXCEPT FOR THE WARRANTIES EXPRESSLY SET FORTH THIS AGREEMENT (INCLUDING THE ACQUIROR DISCLOSURE SCHEDULE), THE ACQUIROR DISCLAIMS ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, WITH REGARD TO THE SUBJECT MATTER OF THIS AGREEMENT.
Section 8.01. [SECTION INTENTIONALLY LEFT BLANK]
Section 8.02. Commercially Reasonable Efforts . Following the date hereof, each of the parties hereto shall use its commercially reasonable efforts to take, or cause to be taken, all action, or to do, or cause to be done, all things necessary, proper or advisable under applicable Laws to consummate and make effective the transactions contemplated by this Agreement, the Supply Agreement td the Related Agreements and to cause the conditions to the obligations of the other party hereto to consummate the transactions contemplated hereby and thereby to be satisfied at the Closing, including obtaining all Elan Third Party Consents, Elan Governmental Consents, Acquirer Governmental Consents and Acquiror Third Party Consents and removing any injunctions or other Encumbrances, other than Permitted Encumbrances, on the Purchased Assets and any impairments or delays the obtaining removal of which are necessary, proper or advisable to the consummation of the transactions contemplated by this Agreement, the Supply Agreement and the Related Agreements.
Section 8.03. Access . (a) In order to facilitate the resolution of any claims made by against or incurred by EPI or any of its Affiliates or any of their respective officers or directors in any Elan Companies Proceeding, upon reasonable notice, the Acquiror shall: (i) afford the officers, employees and authorized agents and representatives of EPI or any of its Affiliates reasonable access (including the right to make copies at their own expense), during normal business hours, to the Product Books and Records; (ii) furnish to the officers, employees and authorized agents and representatives of EPI or any of its Affiliates such additional financial and other information regarding the Business as conducted by EPI relating to the period prior to the Closing as EPI or any of its Affiliates may from time to time reasonably request; (iii) make available to the officers, employees and authorized agents and representatives of EPI or any of its Affiliates the employees of the Acquirer whose assistance, testimony or presence is necessary to assist EPI or any of its Affiliates in evaluating any such claims and/or in prosecuting or defending against such claims, including the presence of such persons as witnesses in hearings or trials for such purposes; and (iv) to the extent that EPI or any of its Affiliates or and of their respective officers of directors is legally required to produce original documents included among the Purchased Assets for inspection in any legal Action or Proceeding, cooperate with EPI or any of its Affiliates or any of their respective officers or directors in making such original documents available for inspection by parties to such Action or Proceeding; provided, however , that the foregoing shall not unreasonably interfere with the business or operations of the Acquiror or any
30
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
of its Affiliates and that all Books and Records to which EPI and its representatives are given such access shall be deemed to be Confidential Information of the Acquiror.
(b) In order to facilitate the resolution of any claims made by or against or incurred by Acquiror or any of its Affiliates or any of their respective officers or directors in any future Action or Proceeding, or the resolution of any written demands relating to alleged Liabilities of Acquiror, EPI shall ensure that EPI, its Affiliates and their respective representatives provide the Acquiror and its representatives with reasonable access during normal business hours to the representatives of EPI and its Affiliates, personnel and assets and to all Books and Records relating to the Business and the Purchased Assets (including the Excluded Books and Records) as the Acquiror may reasonably request; provided that the personnel and operations of EPI, its Affiliates and their respective representatives shall not be unreasonably disrupted by the Acquiror or its Representatives and that all books and Records to which the Acquiror and its representatives are given such access shall be deemed to be Confidential Information of EPI.
(c) Each party agrees to make its respective personnel and those of its Affiliates reasonably available to the other party or its respective representatives to the extent such access is reasonably related to any Excluded Assets, in the case of EPI, or Purchased Assets, in the case of the Acquiror, or is otherwise reasonably necessary to comply with the terms of this Agreement or to comply with any applicable Law, it being understood that the party requesting access shall reimburse the other party promptly for their reasonable and necessary out-of-pocket expenses incurred in complying with my such request.
(d) The Acquiror agrees to maintain all of the Product Books and Records, and EPI agrees to maintain the Excluded Books and Records, for a period of three (3) years after the Closing Date. After such three (3) year period, before either party shall dispose of any such Books and Records, it shall provide to the other party at least ninety (90) calendar days prior written notice to such effect, and such party shall be given an opportunity, at its sole cost and expense, to remove and retain all or any part of such Product Books and Records (other than the Excluded Books and Records).
Section 8.04. Public Announcements: Confidentiality . (a) [SECTION INTENTIONALLY LEFT BLANK]
(b) Each party shall not, and shall require that its Affiliates and its and their advisors and distributors do not, use or reveal or disclose to third parties any Confidential Information of the other party after the Closing without first obtaining the written consent of the other party, except as lay be reasonably necessary in performing such partys obligations or exercising such partys rights under this Agreement (it being understood that any Confidential Information included in the Purchased Assets shall become Confidential Information of the Acquiror following the Closing). Not withstanding the foregoing, each party may disclose any Confidential Information of the other party to its Affiliates and its and their advisors, accountants, attorneys, consultants and agents on a need-to-know basis only, and such party shall be responsible for such Persons compliance with the provisions of this paragraph with respect thereto. Each party shall take, and shall require its Affiliates and its and their advisors, accountants, attorneys, consultants and agents to take, reasonable steps to prevent any
31
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
unauthorized use or disclosure of any Confidential Information of the other party. The foregoing obligations in this Section 8.04(b) shall not apply to. information which (i) is or becomes a matter of public knowledge through no fault of the receiving party or any Person to whom the receiving party provided such information, (ii) the receiving party can demonstrate to have had lawfully in its possession without any obligation of confidentiality prior to disclosure of such information by or on behalf of the disclosing party, (iii) is independently developed by the receiving party without the use of any Confidential Information of the disclosing party as evidenced by written documentation, (iv) is reasonably required to be disclosed in connection with obtaining or maintaining Product Patent Rights or regulatory approvals for the Products, or (v) is required by Law or any Governmental or Regulatory Authority to be disclosed, provided that for disclosures under subclauses (iv) and (v) the disclosing party uses reasonable efforts to give the other party advance written Notice of such required disclosure in sufficient time to enable the other party to seek confidential treatment for such information; and provided , further , that such disclosing party limits the disclosure to that information which is required to be disclosed. As used herein, Confidential Information means all Product Know-How and any proprietary or trade secret information or data relating to the Products or such other information that either party identifies to the other in writing as confidential or the nature of which or the circumstances of the disclosure of which would reasonably indicate that such information is confidential.
(c) The Acquiror acknowledges that it has been informed that information regarding EPI has been requested by the Securities and Exchange Commission and by private litigants in connection with the Elan Companies Proceedings, and waives notice and the opportunity to seek a protective order with respect to the information that has been requested in connection with such Elan Companies Proceedings.
(d) Notwithstanding the confidentiality covenants contained herein, the disclosure of any information governed by the confidentiality covenants contained in this Section 8.04 may be made by EPI or any of its Affiliates without liability hereunder to any of their Affiliates and to any employee, agent, attorney, accountant, consultant or representative who is assisting EPI in prosecuting or defending against any Elan Companies Proceeding.
(e) Notwithstanding the confidentiality covenants contained herein, EPI and any of its Affiliates shall be permitted to use any Confidential Information that EPI or any of its Affiliates in good faith believes to be necessary for purposes of prosecuting or defending an Elan Companies Proceeding, provided, however , that EPI or any of its Affiliates will use its best efforts to obtain an order protecting the confidentiality of such information.
(f) Following the Closing, the confidentiality agreement dated as of April 14, 2004 between EPI and the Acquiror (the Confidentiality Agreement ) will terminate in its entirety with no further obligation on the part of any party thereto, except for paragraphs 1.2, 1.4, 4, 7, 8, 9 and 12 thereof. In addition, the transactions contemplated by this Agreement, the Supply Agreement and the Related Agreements shall not constitute a breach or violation of the terms of the Confidentiality Agreement.
Section 8.05. Returns, Rebates and Chargebacks . (a) (i) Prior to the Returns Termination Date, EPI will, at its sole cost and expense, process and issue credits (or render
32
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
payment in such other form as EPI may determine) for all returned Products. EPI will not bill the Acquiror for the processing of claims for returned Products. Such handling of returned Products by EPI, and the issuance of any credits or other form of reimbursement in connection therewith, shall be in accordance with EPIs current returned goods policy. Subject to Section 8.05(iii), as of the Returns Termination Date, the Acquiror will, at its sole cost and expense, process and issue credits (or render payment in such other form as the Acquiror may determine) for all returned Products. The Acquiror will not bill EPI for the processing of claims for returned Products. Such handling of returned Products by the Acquiror, and the issuance of any credits of other form of reimbursement in connection therewith, shall be in accordance with the Acquirors current returned goods policy.
(ii) EPI and the Acquirer will use reasonable efforts in requesting that customers direct an Product returns prior to the Returns Termination Date to EPI, and after the Returns Termination Date to the Acquiror. All returned Products received by the Acquiror or EPI after the Closing Date will be destroyed by such party at its respective returns handling facility. After such destruction, each party will forward to the other party any necessary accompanying documentation to determine he appropriate credit. If the Acquiror or EPI destroys Products for which the other was financially responsible as set forth in Section 8.05(a)(iii) and (iv), that party shall bill the other party for the cost of the destruction. Each such invoice shall set forth the number of units processed, together with such other information as shall be necessary to support the invoice. Each party shall, within thirty (30) days of its receipt of invoice, pay the other party for the full invoiced amount.
(iii) The parties hereto agree and acknowledge that EPI shall be financially responsible only for returned Products bearing NDC numbers of EPI or any of its Affiliates, evidenced is being sold by EPI (or its Affiliates, sublicensees and marketing, promotion or distribution partners) prior to the Closing and evidenced as being received at either partys returns handling facility on or before the Returns Termination Date. For purposes of this Section 8.05(a)(iii), the dollar value of returned Products paid or credited for by EPI shall be determined in accordance EPIs then current returned goods policy.
(iv) The parties hereto agree and acknowledge that the Acquiror shall be financially responsible for returned Product bearing the Acquirors NDC number, evidenced as being sold after the Closing or evidenced as being received at either partys returns handling facility after the Returns Termination Date. For purposes of this Section 8.05(a)(iv), the dollar value of returned Products raid or credited for by the Acquiror shall be determined in accordance with the Acquirors then current returned goods policy.
(b) (i) EPI shall be financially responsible for all rebates pursuant to any government rebate programs with respect to government claims far the Products indicating NDC numbers EPI or any of its Affiliates and dispensed prior to the Rebates and Chargebacks Termination Date. Any such rebates for Products dispensed subsequent to the Rebates and Chargebacks Termination Date will be the liability of the Acquiror. The Acquiror shall reimburse EPI for all rebates that EPI is obligated to pay with respect to government claims for the Products dispensed after such date (it being understood and agreed that the dispense date contained in any report from a state rebate program shall be used for purposes of determining such date). All payments due EPI under this Section 8.05(b) shall be made within thirty (30) days
33
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
of submission to the Acquiror of invoices that describe the requested payments in reasonable detail.
(ii) The Acquiror acknowledges that EPI will require certain information from the Acquiror in order to calculate the Medicaid rebate for Products bearing NDC numbers of EPI or any of its Affiliates. Accordingly, the Acquiror agrees that, from and after the Closing Date until the date which is one year after the expiration date of the last lot of Products produced with any NDC number of EPI or any of its Affiliates, the Acquiror will provide to EPI, within five (5) days following the delivery of related information to the Centers for Medicare and Medicaid Services (or any successor agency), the following information: (a) the best price (as defined under the Social Security Act, 42 U.S.C. § 1396r-8(c)(1)(C)) for each Product identified by NDC number, (b) the average manufacturer price (as defined under the Social Security Act, 42 U.S.C. § 1396r-8(k)(1)) for each Product identified by the NDC number, and (c) any additional data or other information related to such Medicaid issues reasonably requested by EPI. EPI will provide the same information to Acquiror on the same basis with respect to Products sold by EPI prior to the Closing to the extent that such information is not included in the Product Books and Records.
(c) EPI shall be responsible for all commercial rebates with respect to the Products dispensed prior to the Rebates and Chargebacks Termination Date. Notwithstanding the foregoing, the Acquiror and EPI agree that (a) EPIs financial liability for the commercial rebates prior to such date shall be limited to those commercial customers with which EPI has a rebate obligation as of the Closing and (b) any such payments by EPI shall be made on the terms and conditions comparable to EPIs rebate obligations as of the Closing with respect to each such commercial customer and shall be based on the terms of EPIs agreement with such customer as of the Closing. Any rebates for Products dispensed subsequent to the Rebates and Chargebacks Termination Date will be the liability of the Acquiror. To the extent that EPI processes such claims, the Acquiror shall reimburse EPI within thirty (30) days of receipt of (i) invoices that describe the requested payments in reasonable detail together with copies of the original underlying invoices submitted to EPI
(d) EPI shall be financially responsible for all chargeback claims and related Administrative Fees for the Products with a chargeback invoice dated ( i.e. , the date of sale from the wholesaler to the wholesaler customer, subsequently referred to as the Activity Date ) prior to the Chargebacks Termination Date. The Acquiror shall process and be financially liable for all chargeback claims and related Administrative Fees with an Activity Date subsequent to such date. Notwithstanding the foregoing, the parties acknowledge that the VA National Acquisition Center must approve the removal of the Products from EPFs Federal Supply Schedule (FSS) before the responsibility of processing such chargebacks is transferred from EPI to the Acquirer. Accordingly, in the event such approval is not obtained prior to the Closing Date, EPI shall continue to be responsible for processing the FSS chargebacks and related Administrative Fees on the Acquirers behalf, and the Acquiror shall reimburse EPI for same within thirty (30) days of receipt of invoices that describe the requested payments in reasonable detail together with copies of the original underlying invoices submitted to EPI. The Acquiror and EPI agree that (a) EPIs financial liability for such transition chargebacks and related Administrative Fees shall be limited to those commercial customers with which EPI has chargeback obligations as of the Closing, and (b) any such chargebacks and related Administrative Fees issued by EPI shall be
34
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
made on the terms and conditions comparable to EPIs chargeback obligations as of the Closing with respect to each such commercial customer and shall be based on the terms of EPIs agreement with such customer as of the Closing.
(e) Notwithstanding the requirements of Section 8.05(b), the Acquiror and EPI agree that EPIs financial liability for governmental rebates shall terminate on the date that is one hundred eighty (180) days after the Closing Date, except with respect to governmental rebates relating to utilization data submitted to EPI prior to the Rebates add Chargebacks Termination Date (for which EPIs responsibility and financial liability shall not terminate). Notwithstanding the requirements of Section 8.05(c) or (d), the Acquiror and EPI agree that EPIs financial liability for commercial rebates and chargeback claims and related Administrative Fees shall terminate on the date that is one hundred twenty (120) days after the Closing Date.
(f) The Acquiror agrees that it shall not increase the wholesale acquisition cost of the Products prior to the date that is one hundred eighty (180) days after the Closing Date.
(g) EPI shall promptly provide the Acquiror with all information required to permit the Acquiror to comply with its obligations to sell-the Products under the Public Health Services Act after the Closing ( i.e., the AMP and Rebates Per Unit ( RPU ) for the Products for the two full calendar quarters, and any partial calendar quarter, immediately preceding the Closing Date). The parties promptly after Closing shall make all filings with Health Resources Services Administration and the Veterans Administration necessary to transfer the obligation to sell Products under the Public Health Services Act after the Closing from EPI to the Acquiror.
Section 8.06. Multi-Product Contracts . Schedule 8.06 of the Elan Disclosure Schedule sets forth a complete and correct list of each Contract to which EPI is a party and pursuant to which EPI sells any of the Products, together with other pharmaceutical products of EPI or its Affiliates, to a third party (the Multi Product Contracts ). Except as specified in Schedule 8.06 of the Elan Disclosure Schedule, within ten (10) Business Days following the Closing, EPI shall (a) take all actions necessary to terminate such Multi-Product Contracts to the extent that they pertain to the Products in the shortest period of time permitted thereunder, and (b) inform the other parties to such Multi-Product Contracts of the acquisition of the Purchased Assets by the Acquiror and notify them that they must submit all utilization within the timeframe required by such Contract in order to be paid thereunder. From and after the sixth day following the Closing, the Acquiror may contact any Person who is a party to a Multi-Product Contract for the purposes of (i) negotiating an agreement relating to the Products with such Person, and (ii) informing such Person of the acquisition of the Purchased Assets by the Acquiror and notifying them that any utilization must be submitted within the timeframe required by the relevant Multi-Product Contract.
Section 8.07. Bulk Transfer Laws . The Acquiror and EPI hereby waive compliance with the provisions of any so-called bulk transfer law of any jurisdiction in connection with the sale of the Purchased Assets to the Acquiror.
Section 8.08. Further Assurances . (a) On and after the Closing Date, EPI shall, from time to time, at the request of the Acquiror, execute and deliver, or cause to be executed
35
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
and delivered, such other instruments of conveyance and transfer and take such other actions as the Acquiror may reasonably request, in order to (i) more effectively consummate the transactions contemplated hereby, in the Supply Agreement and in the Related Agreements and to vest in the Acquirer good and marketable title to the Purchased Assets (including assistance in the collection or reduction to possession of any of the Purchased Assets), and (ii) transfer to the Acquiror those assets that are necessary for the conduct of the Business that were not included in the Purchased Assets.
(b) On and after the Closing Date, the Acquiror shall, from time to time, at the request of EPI, take such actions as EPI may reasonably request, in order to more effectively consummate the transactions contemplated hereby, in the Supply Agreement and in the Related Agreements, including the Acquirors assumption of the Assumed Liabilities.
Section 8.09 Corporate Names . (a) The Acquirer shall be entitled to continue to use the Corporate Names and the NDC number of EPI or its Affiliates for the Products on the existing Labeling and-packaging for the Products until such time as the Acquiror has prepared and filed with the appropriate Governmental or Regulatory Authorities, and such authorities approve, if required, new Labeling that does not contain references to the Corporate Names or such NDC numbers; provided however , that, if the Acquiror does not prepare within ninety (90) days of the Closing Date final specifications for such revised Labeling and packaging of the Products, including new NDC numbers for the Products and all necessary photo-ready art (or its substantial equivalent) reflecting such modifications, the right of the Acquiror described in this sentence shall terminate ninety (90) days after the Closing Date. Notwithstanding the foregoing, the Acquiror shall be entitled to continue to use the Corporate Names that consist of trademarks of EPI or its Affiliates debossed or otherwise included on Zanaflex Tablets as of the Closing on Zanaflex Tablets until the date that is one hundred eighty (180) days after the Closing Date. Subject to the terms and conditions herein, EPI hereby grants a non-exclusive, non-transferable license to the Acquiror and its Subsidiaries to use the Corporate Names on the Labeling and packaging of the Products and on Zanaflex Tablets themselves, in each case to the extent specified herein.
(b) Corporate Names means the trademark and service mark ELAN, the Corporate logos and trade names of EPI and its Affiliates, including the word ELAN together with any variations and derivatives thereof and any other logos, symbols or trademarks, trade names or service marks of EPI and its Affiliates (including for the avoidance of doubt any trademarks of EPI or is Affiliates debossed or otherwise included on Zanaflex Tablets themselves), but excluding the Product Trademarks.
(e) EPI and/or its Affiliates, as applicable, retain and shall retain all right, title and interest in and to the Corporate Names. The Acquiror expressly acknowledges that EPI and/or its Affiliates own the Corporate Names, and agrees that it will not attack, dispute or contest the validity of or ownership of the Corporate Names, or any registrations issued or issuing with respect thereto. The Acquirer further agrees that all use of the Corporate Names by the Acquiror or its Affiliates shall be for the benefit of EPI and/or its Affiliates and the goodwill accrued in connection with its use of the Corporate Names shall accrue to EPI and/or its Affiliates. In the event the Acquirer acquires any rights relating to the Corporate Names for any reason, the Acquiror agrees to assign, at no cost, all such rights, together with any related
36
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
goodwill, to EPI. The Acquiror shall use best efforts not to do any act which endangers, destroys or similarly affects the value of the goodwill pertaining to the Corporate Names and further agrees that it will ensure that all Products comply with the quality standards and specifications of Elan in existence as of the Closing Date and at all times with at least the same standards as Elan employs for its other products taking into account the nature of the Products and the quality of their manufacture and distribution, including but not limited to the applicable laws, rules or regulations of any Governmental or Regulatory Authority having jurisdiction over the manufacture and distribution of the Products. Except as provided in this Section 8.09, the Acquiror farther agrees that it will not alter, change, deface or obliterate the Corporate Names on Labeling for the Product. The Acquirer will at anytime execute any documents reasonably required by EPI to confirm all ownership interests of EPI and/or its Affiliates in the Corporate Names. The Acquirer shall not use in connection with the Product, or allow any of its Affiliates to use in connection with the Product, any other trademark or trade name which is similar to or substantially similar, to or so nearly resembles the Corporate Names as to be likely to cause deception or confusion.
Section 8.10. Protective Covenant . (a) During the period beginning at the Closing and ending on the third (3 rd ) anniversary of the Closing Date, the Acquiror shall not, directly or indirectly, market, distribute or sell in the United Kingdom or Ireland any pharmaceutical product containing tizanidine or any chiral isomer of tizanidine as its active pharmaceutical ingredient.
(b) During the period beginning at the Closing and ending on the later of (i) the date that the Supply Agreement (or any superceding agreement between the parties with respect to the supply of Zanaflex Capsules by EPI to the Acquiror) is validly terminated, or (ii) the date the EPI Royalty Term ends, EPI shall not, directly or indirectly, market, distribute or sell in the Territory any pharmaceutical product containing tizanidine or any chiral isomer of tizanidine as its active pharmaceutical ingredient.
Section 8.11. Commercialization of Zanaflex Capsules . Subject to EPIs and its Affiliates continuing performance of their obligations under this Agreement, the Supply Agreement and the Related Agreements, the Acquiror hereby covenants and agrees that it will use commercially reasonable efforts after the Closing Date to commercialize Zanaflex Capsules.
Section 8.12. Zanaflex Tablet Business . From and after the Closing during calendar year 2004, the Acquirer will conduct the Business relating to Zanaflex Tablets using the same commercially reasonable efforts that would be used by a pharmaceutical company similarly situated, including but not limited to filling orders as they are received for Zanaflex Tablets.
37
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Section 11.01. Survival of Representations, Warranties, Covenants, Etc. (a) The representations and warranties and covenants and agreements to be performed at the Closing of EPI or the Acquiror contained in this Agreement shall survive the Closing and terminate 12 months following the Closing Date (the Expiration Date ). Notwithstanding the preceding sentence, so long as an Indemnified Party gives an Indemnification Claim Notice for any claim for indemnification on or before the Expiration Date, such Indemnified Party shall be entitled to pursue its rights to indemnification for such claim.
(b) The representations, Warranties, covenants and agreements of EPI and the Acquiror, and the rights and remedies that may be exercised by the Acquiror Indemnitees and the EPI indemnitees, shall not be limited or otherwise affected by or as a result of any information furnished to, or any investigation made by or any knowledge of, any of the Acquiror Indemnitees or EPI Indemnitees or m y of their respective Representatives.
(c) For purposes of this Agreement, each statement or other item of information set forth in the Elan Disclosure Schedule shall be deemed to be a representation and warranty made by EPI in this Agreement; and each statement or other item of information set forth in the Acquiror Disclosure Schedule shall be deemed to be a representation and warranty made by the Acquiror in this agreement.
(d) Nothing contained in this Section 11.01 or elsewhere in this Agreement shall limit any rights or remedy of any indemnified party for claims based on fraudulent or intentional misrepresentation.
Section 11.02. Indemnification .
(a) By EPI. Subject to Sections 11.01 and 11.03, from and after the Closing, EPI shall indemnify, reimburse, compensate, defend and hold harmless the Acquiror, its Affiliates and their respective officers, directors, employees, agents, successors and assigns (the Acquiror Indemnitees ) from and against any and all costs, losses, damages, including natural resource damages, fines, penalties, judgments, lawsuits, deficiencies, claims and expenses (including reasonable fees and disbursements of attorneys and other professionals, including third-party consultants and, to the extent allowable at Law, medical monitoring costs and expenses) of every kind and nature (collectively, Damages ) incurred in connection. with, arising out of, resulting from or incident to (regardless of whether or not such Damages relate to any third-party claim): (i) any inaccuracy in or breach of a representation or warranty of EPI made in this Agreement or any Related Agreement, (ii) any inaccuracy in or breach of a representation or warranty of EPI made in this Agreement or any Related Agreement as of the Closing Date as if made on the Closing Date (or, in the case of each representation and warranty
38
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
which expressly speaks as of an earlier date, as of the earlier date as of which such representation and warranty speaks), (iii) any breach of any covenant or agreement of EPI in this Agreement or any Related Agreement, (iv) any Excluded Liabilities and (v) any Action or Proceeding relating directly or indirectly to any inaccuracy, breach, alleged inaccuracy or breach, Liability or matter of the type referred to in clauses (i), (ii), (iii), or (iv) above (including any Action or Proceeding commenced by any Acquiror Indemnitee for the purpose of enforcing any of its rights under this Article XI).
(b) By the Acquiror . Subject to Sections 11.01 and 11.03, from and after the Closing, the Acquiror shall indemnify, reimburse, compensate, defend and hold harmless EPI, its Affiliates and their respective officers, directors, employees, agents, successors and assigns (the EPI Indemnitees ) from and against any and all Damages incurred in connection with, arising out of, resulting from or incident to (regardless of whether or not such Damages relate to any third-party claim): (i) any inaccuracy in or breach of a representation or warranty of the Acquiror made in this Agreement or any Related Agreement, (ii) any inaccuracy in or breach of a representation or warranty of the Acquiror made in this Agreement or any Related Agreement as of the Closing Date as if made on the Closing Date (or, in the case of each representation and warranty which expressly speaks as of an earlier date, as of the earlier date as of which such representation and warranty speaks), (iii) any breach of any covenant or agreement of the Acquiror in this Agreement or any Related Agreement, (iv) any Assured Liabilities and (v) any Action or Proceeding relating directly or indirectly to any inaccuracy, breach, alleged inaccuracy or breach, liability or matter of the type referred to in clauses (i), (ii), (iii), or (iv) above (including any Action or Proceeding commenced by any EPI Indemnitee for the purpose of enforcing any of its rights under this Article XI).
(c) Procedure for Claims . If any indemnified party has or claims to have incurred or suffered Damages for which it is or may be entitled to indemnification, compensation or reimbursement under this Article XI, and the indemnified party wishes to make a claim for the recovery of such Damages from an indemnifying party, such indemnified party shall deliver a Notice (an Indemnification Claim Notice ) to the indemnifying party. Each Indemnification Claim Notice shall (i) state that such indemnified party believes that that there is or has been a breach of a representation, warranty or covenant contained in the Agreement or that such indemnified party is otherwise entitled to indemnification, compensation or reimbursement under this Article XI, (ii) contain a brief description of the circumstances supporting such indemnified, partys belief that there is or has been such a possible breach or that such indemnified party is so entitled to indemnification, compensation or reimbursement, and (iii) if practicable contain a good faith, non-binding, preliminary estimate of the aggregate dollar amount of actual and potential damages that have, arisen and may arise as a result of such breach or other matter as set forth in such Indemnification Claim Notice. For the avoidance of doubt, the parties agree that if an indemnified party is entitled to make an indemnification claim under more than one clause of either Section 11.02(a) or 11.02(b), as applicable, the indemnified party may make such claim under any or all of the applicable provisions.
(d) Third Party Claims . The obligations of an indemnifying party under this Section 11.02 with respect to Damages arising from claims or legal proceedings of any third party that are subject to indemnification as provided for in Section 11.02(a) or Section 11.02(b)
39
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
(a Third Party Claim ) shall be governed by and be contingent upon the following additional terms and conditions:
(i) If (A) the indemnified party receives written notice of the commencement of any Third Party Claim against any indemnified party, and (B) a claim for indemnification is to be made against the indemnifying party under this Agreement with respect to such Third Party Claim, then the indemnified party shall promptly notify the indemnifying party of the commencement of such Third Party Claim; provided, however , that any failure to notify the indemnifying party of the commencement of such Third Party Claim shall not limit or otherwise affect any rights of the indemnified party or any liability that the indemnifying party may have to any indemnified party (except to the-extent that the defense of such Third Party Claim has been materially prejudiced by the indemnified partys failure to notify the indemnifying party of the commencement of such Third Party Claim). If, within thirty (30) days after receiving notification of the commencement of any Third Party Claim, the indemnifying party delivers to the indemnified party a written notice setting forth the election of the indemnifying party to assume the defense of such Third Party Claim, then, subject to subsections (ii) and (iii) below:
(A) the indemnifying party shall be entitled to assume the defense of such Third Party Claim, at the sole expense of the indemnifying party, with counsel reasonably satisfactory to the indemnified party; and
(B) as long as the indemnifying party conducts such defense, the indemnifying party shall not be required to reimburse the indemnified party for any fees paid to any other counsel representing such indemnified party in such Third Party Claim for legal services rendered while the indemnifying party is conducting such defense (it being understood that the indemnifying party shall be required to reimburse the indemnified party for any fees paid to counsel representing the indemnified party in such Third Party Claim for legal services rendered prior to the time the indemnified party receives notice of the election of the indemnifying party to assume such defense).
(ii) If the indemnifying party assumes the defense of a Third Party Claim in accordance with subsection (i) above, then:
(A) it will be deemed conclusively established for purposes of this Agreement that such Third Party Claim is within the scope of and are subject to the indemnification provisions set forth in Section 11.02, and the indemnifying party shall not be permitted to contest the applicability of Section 11.02 to such Third Party Claim or to contest the indemnifying partys obligation to provide indemnification to the indemnified party with respect thereto;
(B) the indemnified party shall promptly deliver to the indemnifying party all original notices and documents (including court papers) received by any indemnified party in connection with the Third Party Claim.
40
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
(C) the indemnifying party shall keep the indemnified party informed of all material developments relating to such Third Party Claim;
(D) the indemnified party shall be entitled to participate (at its own expense) in the defense of such Third Party Claim; and
(E) the indemnifying party shall not be permitted to effect any settlement, adjustment or compromise of such Third Party Claim or any of the claims made in connection therewith without the prior written consent of the indemnified party (which consent shall not be unreasonably withheld or delayed) unless (I) such settlement, adjustment or compromise involves no finding or admission of any breach by any indemnified party of any obligation to any other Person or any violation by any indemnified party of any Law, (II) such settlement, adjustment or compromise has no effect on any other claim that may be made against any indemnified party, (III) the sole relief provided in connection with such settlement, adjustment or compromise is monetary damages that are paid in full by the indemnifying party, and (IV) the indemnified party receives a full release with respect to such claim.
If the indemnifying party does not elect (within the 30-day lime period specified in subsection (i) above) to assume the defense of a Third Party Claim in accordance with subsection (i) above, then (I) the indemnified party shall have the exclusive right, at its election, to control the defense of such Third Party Claim with counsel selected by the indemnified party and reasonably satisfactory to the indemnifying party, (II) provided that the indemnifying party is adjudged to be obligated to indemnify he indemnified party hereunder, the indemnifying party shall not be entitled to challenge the manner in which the Third Party Claim was litigated by the indemnified party and its counsel or the judgment or other outcome of the Third Party Claim, and (iii) the indemnifying party will not be bound by any settlement, adjustment or compromise effected by the indemnified party with respect to such Third Party Claim or of any of the claims made in connection therewith that is of effected without the prior written consent of the indemnifying party (which consent shall not be unreasonably withheld or delayed).
(iii) Notwithstanding anything to the contrary contained in this Section 11.02(d), and notwithstanding any election made by the indemnifying party to assume the defense of any Third Party Claim in accordance with subsection (i) above, if any indemnifying party or any affiliate of any indemnifying party is also a party to such Third Party Claim, and counsel to the indemnified party determines in good faith that joint representation would give rise to a conflict of interest in such Third Party Claim, then the indemnified party may retain its own legal counsel at the expense of the indemnifying party, and the indemnifying party and its counsel shall cooperate with the Indemnified Party and its counsel as may be reasonably requested.
(iv) Regardless of whether the indemnifying party or the indemnified party defends or prosecutes any Third Party Claim, each non-defending party shall, and shall cause each Affiliate of any such non-defending party to, cooperate in the defense or prosecution thereof and shall furnish such records, information and testimony, provide such witnesses and
41
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
attend such conferences, discovery proceedings, hearings, trials and appeals as maybe reasonably requested in connection therewith. Such cooperation shall include access during normal business hours afforded to the defending party to, and reasonable retention by each non-defending party of, records and information that are reasonably relevant to such Third Party Claim, and making each non-defending party and other employees and agents thereof available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder, and the indemnifying party shall reimburse each such Person for all its reasonable out-of-pocket expenses in connection therewith.
Section 11.03. Limitations .
(a) With the exception of claims based upon fraudulent misrepresentation, in no event shall an indemnifying party be liable for any Damages pursuant to a claim based upon a representation, warranty or covenant pursuant to (i) Sections 11.02(a)(i),11.02(a)(ii) or 11.02(a)(iii) (other than claims for breach of the covenant set forth in Section 8.10(b)) or (ii) Sections 11.02(b)(i),11.02(b)(ii) or 11.02(b)(iii) (other than claims for breach of the covenant set forth in Section 8.10(a)), as applicable (each of the claims set forth in clauses (i) and (ii) above is referred to as an Eligible Claim ), unless and until the aggregate amount of all such Damages for all Eligible Claims payable by such indemnifying party exceeds [***] in which case the indemnifying party shall be liable for all such Damages, and not only those Damages in excess of such amount. With the exception of claims based upon fraudulent misrepresentation or claims for breach of the covenants set forth in Sections 8.10(a) or 8.10(b), the maximum aggregate amount payable by an indemnifying party pursuant to all Eligible Claims payable by such indemnifying party shall in no event exceed [***]. Further, with the exception of claims based upon fraudulent misrepresentation, each party hereto agrees that the indemnification rights provided by Section 11.02 are the sole and exclusive remedy for monetary damages for claims by such party or any Acquiror Indemnitee or EPI Indemnitee for breach by the other party of any representation, warranty or covenant contained in this Agreement.
(c) Any indemnifying party shall also be liable to the indemnified party for interest on the amount of any Damages that such indemnified party is entitled to recover from the indemnifying party (for the period commencing as of the date on which the indemnified party delivered the applicable Notice of Indemnification Claim to the indemnifying party and ending on the date on which the liability of such indemnifying party to such indemnified party is fully satisfied by such indemnifying party) at a floating rate equal to the prime rate publicly announced by Morgan Guaranty Trust Company of New York at its principal office from time to time plus 2% (or, if less, the maximum rate allowed to be charged under applicable laws), such interest to be compounded monthly.
(d) In the event of a dispute regarding the amount of Damages recoverable in connection with an indemnification claim, the indemnifying party and the indemnified party may bring evidence regarding the quantification of such Damages, including evidence relating to insurance proceeds recovered by the indemnified party in connection with the events underlying such indemnification claim and any related increases in insurance premiums payable by the indemnified party, and the amount of any tax benefit gained or any tax increase or disadvantage suffered in connection with such indemnification claim.
42
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
(e) THE INDEMNIFICATION OBLIGATIONS OF THE PARTIES HERETO SHALL NOT EXTEND TO SPECIAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES, INCLUDING BUSINESS INTERRUPTION OR LOST PROFITS, OR PUNITIVE DAMAGES, UNLESS SUCH DAMAGES ARE AWARDED IN CONNECTION WITH, OR INCLUDED IN A SETTLEMENT, ADJUSTMENT OR COMPROMISE OF, A THIRD PARTY CLAIM.
Section 13.01. Notices . All Notices, requests and other communications hereunder must be in writing and will be deemed to have been duly given (a) if delivered personally, upon receipt, (b) if delivered by facsimile transmission, upon receipt by the sender of the answer back confirmation, (c) if mailed, postage prepaid by certified or registered mail, return receipt requested, upon receipt, or (d) if delivered by nationally recognized overnight courier that maintains records of delivery, upon receipt (in each case regardless of whether such Notice, request or other communication is received by any other Person to whom a copy of such Notice, request or other communication is to be delivered pursuant to this Section 13.01), in each case to the patties at the following addresses or facsimile numbers:
If to the Acquiror to:
Acorda Therapeutics
15 Skyline Drive
Hawthorne, NY 10532
Facsimile: (914) 347-4560
Attention: General Counsel
If to EPI to:
Elan Pharmaceuticals, Inc.
800 Gateway Boulevard
South San Francisco, CA 94080
Facsimile: (650) 553-7165
Attention: Vice President, Legal Affairs.
Either party from time to time may change its address, facsimile number or other information for the purpose of Notices to that party by giving Notice specifying such change to the other party hereto in accordance with the terms of this Section 13.01.
Section 13.02. Entire Agreement . This Agreement (and all Exhibits and Schedules attached hereto and all other documents delivered in connection herewith) supersedes all prior discussions and agreements among the parties with respect to the subject matter hereof
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
and contains the sole and entire agreement among the parties hereto with respect to the subject matter hereof (except as otherwise set forth in Section 8.04(f)).
Section 13.03. Waiver . Any term or condition of this Agreement may be waived at any time by the party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the party waiving such term or condition. No waiver by any party hereto of any term or condition of this Agreement, in any one or more instances, shall be deemed to be or construed as a waiver of the same or any other term or condition of this Agreement on any future occasion. All remedies, either under this Agreement or by law or otherwise afforded, will be cumulative and not in the alternative.
Section 13.04. Amendment . This Agreement may be amended, supplemented or codified only by a written instrument duly executed by each party hereto.
Section 13.05. Third Party Beneficiaries . The terms and provisions of this Agreement are intended solely for the benefit of each party hereto and their respective successors or permitted assigns and it is not the intention of the parties to confer third party beneficiary rights upon any other Person, except as achieved through the indemnification clause set forth in Section 11.02.
Section 13.06 Assignment: Binding Effect . Neither this Agreement nor any right, interest or obligation hereunder may be assigned by any party hereto without the prior written consent of the other party hereto and any attempt to do so will be void, except that an Indemnified Party under article XI may assign any of its rights, benefits or obligations hereunder, by operation of law or otherwise, (a) to any of its Affiliates, provided such Indemnified Party continues to be responsible for all of its obligations hereunder, (b) to a Person that (i) purchases all or substantially all of the assets being conveyed hereunder or (ii), merges with the Acquiror or the Indemnified Party or (c) to the lenders of the Acquiror and its successors or assigns; provided, however , such assignment does not create adverse consequences for the indemnifying party. This Agreement is binding upon, inures to the benefit of and is enforceable by the parties hereto and their respective successors and permitted assigns.
Section 13.07. Headings . The headings used in this Agreement have been inserted for convenience of reference only and do not define or limit the provisions hereof.
Section 13.08. Elan Patenting . Subject to Section 2.02, nothing in this Agreement shall be deemed to prevent or prohibit EPI or its Affiliates from filing, maintaining, licensing, prosecuting or enforcing any rights arising out of intellectual property purchased or licensed after the Closing or relating to inventions reduced to practice after the Closing.
Section 13.09. Severability . If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future law, and if the rights or obligations of any party hereto under this Agreement will not be materially and adversely affected thereby, (i) such provision will be fully severable, (ii) this Agreement will be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a part hereof, (iii) the remaining provisions of this Agreement will remain in full force and effect and will not be
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
affected by the illegal, invalid or unenforceable provision or by its severance herefrom, and (iv) in lieu of such illegal, invalid or unenforceable provision, there will be added automatically as a part of this Agreement a legal, valid and unenforceable provision as similar to the terms of such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the parties herein.
Section 13.10. Governing Law: Jurisdiction . THIS AGREEMENT AND THE RELATED AGREEMENTS SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF NEW YORK APPLICABLE TO CONTRACTS EXECUTED AND PERFORMED IN SUCH STATE, WITHOUT GIVING EFFECT TO CONFLICTS OF LAWS PRINCIPLES. EACH PARTY HERETO HEREBY SUBMITS TO THE EXCLUSIVE JURISDICTION OF THE FEDERAL AND NEW YORK STATE COURTS LOCATED IN THE CITY OF NEW YORK IN CONNECTION WITH ANY DISPUTE RELATED TO THIS AGREEMENT OR ANY RELATED AGREEMENT OR ANY MATTERS CONTEMPLATED HEREBY OR THEREBY. SERVICE OF ANY PROCESS, SUMMONS, NOTICE OR DOCUMENT BY REGISTERED MAIL ADDRESSED TO ANY PARTY HERETO AT THE ADDRESS SET FORTH FOR SUCH PARTY HEREIN SHALL BE EFFECTIVE SERVICE OF PROCESS AGAINST SUCH PARTY FOR ANY SUIT, ACTION OR PROCEEDING BROUGHT IN ANY SUCH COURT. EACH PARTY HERETO IRREVOCABLY AND UNCONDITIONALLY WAIVES ANY OBJECTION TO THE LAYING OF VENUE OF ANY SUCH SUIT, ACTION OR PROCEEDING BROUGHT IN ANY SUCH COURT AND ANY CLAIM THAT ANY SUCH ACTION OR PROCEEDING HAS BEEN BROUGHT IN AN INCONVENIENT FORUM. A FINAL JUDGMENT IN ANY SUCH SUIT, ACTION OR PROCEEDING BROUGHT IN ANY SUCH COURT MAY BE ENFORCED IN ANY OTHER COURTS TO WHOSE JURISDICTION SUCH PARTY IS OR MAY BE SUBJECT, BY SUIT UPON JUDGMENT
Section 13.11 Expenses . Except as otherwise provided in this Agreement, the Supply Agreement or the Related Agreements, each party hereto shall pay its own expenses and costs incidental to the preparation of this Agreement, the Supply Agreement and the Related Agreements and to the consummation of the transactions contemplated hereby and thereby.
Section 13.12 Counterparts . This Agreement may be executed in any number of counterparts and by facsimile, each of which will be deemed an original, but all of which together will constitute one and the same instrument. A facsimile copy shall be a sufficient proof of signature, without it being necessary to produce the original copy.
[SIGNATURES ON FOLLOWING PAGE]
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
IN WITNESS WHEREOF, this Agreement has been executed by the parties hereto all as of the date first above written.
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Jack Laflin |
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Global Core Services |
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S-1
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
IN WITNESS WHEREOF, this Agreement has been executed by the parties hereto all as of the date first above written.
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Ron Cohen |
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President and CEO |
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S-1
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
ELAN DISCLOSURE SCHEDULE
The following matters are disclosures made in connection with the representations and warranties of Elan Pharmaceuticals, Inc., a Delaware corporation (EPI), set forth in the Asset Purchase Agreement (the Agreement) by and between EPI and Acorda Therapeutics, Inc., a Delaware corporation (Acquiror) and delivered in connection with the execution and delivery of the Agreement by EPI. Section numbers used herein correspond to the section numbers in the Agreement; provided, however, that any information disclosed herein under a particular section number shall be deemed to be disclosed and incorporated into another section number contained herein if such information reasonably relates to the representation and warranty m the Agreement that corresponds to such other section number. Except as otherwise stated or the where the context indicates-otherwise, all capitalized terms used herein shall have the meanings given them in the Agreement.
Nothing herein constitutes an admission against EPIs interests. The inclusion of any item herein should not be interpreted as. indicating that EPI has determined that such item or other matter is necessarily material to Acquiror. Acquiror acknowledges that certain information contained in this Elan Disclosure Schedule may constitute confidential information relating to EPI and/or its Affiliates, and therefore may be subject to the confidentiality provisions contained in the Agreement. Where the terms of disclosure items may have been summarized, disclosed or otherwise described in this Elan Disclosure Schedule, such summary, disclosure or description does not purport to be a complete statement of the material terms of such item. For the avoidance of doubt, and notwithstanding anything in the Agreement or herein to the contrary, the contents of each document made available to Acquiror in the dataroom by EPI for due diligence purposes shall be deemed to be disclosed and incorporated into each section number contained herein if such contents reasonably relate to the representation and warranty in the Agreement that corresponds to such section number.
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Schedule 1.01 (a) - Closing Date Inventory Value -valuation methodology
Lot Number |
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Strength |
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Units per lot |
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Unit price |
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37584 |
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4 mg |
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[***] |
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[*** |
] |
37583 |
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4 mg |
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[***] |
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[*** |
] |
23934(a) |
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4 mg |
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[***] |
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N/A |
(b) |
23934(a) |
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4 mg |
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[***] |
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N/A |
(b) |
33535(a) |
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2 mg |
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[***] |
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N/A |
(b) |
37329(a) |
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2 mg |
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[***] |
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N/A |
(b) |
37329(a) |
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2 mg |
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[***] |
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N/A |
(b) |
(a) Denotes Inventory having a shelf life of less than 12 months from the Closing Date.
(b) Each such batch will be included for an aggregate purchase price (for all such batches) of [***] .
Schedule 1.01(b) Domain Names
ZANAFLEX.BIZ
ZANAFLEX.COM
ZANAFLEX.INFO
ZANAFLEX.NET
ZANAFLEX.ORG
ZANAFLEX.US
Schedule 1.01(c) Excluded Books and Records
1. All information provided to EPI or its Affiliates by or pursuant to contracts with IMS Health, Verispan, L.L.C. (formerly, Scott Levin) and NDC Health Information Services.
2. EPI shall not be providing to Acquiror any Books and Records or Know-How embodying any calculation methods or policies, processes or procedures relating to government or commercial rebates and chargeback claims.
Schedule 1.01(d) Product Copyrights
1. No Copyrights have been registered with the U.S. Copyright Office.
2. All Copyrights in the Product Books and Records (including for the avoidance of doubt the Product Marketing Materials) and the Labeling.
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Schedule 1.01(e) Product Know-How
All Know-How contained in, and in the data underlying, the following clinical study reports:
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Title |
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AN021-301 |
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A Placebo-Controlled, Double-blind, Randomized, parallel Groups, Single Dose Study to Assess Efficacy and Safety of Tizanidine Hydrochloride Modified Release in Patients with Spasticity due to Multiple Sclerosis or Spinal Cord Impairment Treated with 24 or 48 mg |
AN021-302 |
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A Placebo-Controlled, Double-Blind, Randomized, parallel Groups Study to Assess Efficacy and Safety of Tizanidine Hydrochloride Modified Release at Stable Dose in Patients with Spasticity due to Multiple Sclerosis or Spinal Cord Impairment |
AN021-351 |
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Open-Label Study of Tizanidine Hydrochloride Modified Release in Patients with Spasticity Due to Multiple Sclerosis of Spinal Cord Impairment |
AN021-002 |
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A Multicenter, Open-Label, Long Term Study to Evaluate the Safety of Tizanidine Tablets in Patients Suffering from Spasticity due to Multiple Sclerosis |
AN021-004 |
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A Multicenter, Open-Label, Long-Term Study to Evaluate the Safety of Tizanidine Tablets in Patients Suffering from Spasticity Resulting from Spinal Cord Injury |
AN021-103 |
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A Pharmacokinetic Study to Evalute the Bioequivalence of Zanaflex (Tizanidine Hydrochloride) 2 x 2 mg Tablets, with Varying Storage Times, Administered to Healthy subjects |
AN021-401 |
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An Open-Label Study to Assess the Long-Term Safety of Zanaflex (tizanidine HCI) in Patients Treated with 28 to 36 mg/day. |
AN021-456 |
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Open Label Dose Titration Study of the Safety and Efficacy of Zanaflex (tizanidine HCI) in Chronic Daily Headache Prophylaxis. |
Notwithstanding the foregoing or anything in the Agreement or herein to the contrary, neither EPI nor any of its Affiliates makes any representations or warranties of any nature regarding such study reports or the underlying data.
Schedule 1.01(f) Product Patent Rights
1. U.S. Patent No. 6,455,557 dated September 24, 2002.
2. U.S. Patent Application No. 10/645,840, filed August 22, 2003.
2
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Schedule 1.01(g) Product Trademarks
1. The Trademark Zanaflex is used in the United States (registration number 1906277).
2. The Trademark Zana flex is used in the United States (registration number 2383531).
Schedule 2.01 (a) Assumed Contracts
The Novartis License Agreement (including the amendment to such agreement dated May 3, 1991 and the Addendum to such agreement dated February 24, 1995, which documents constitute all of the amendments to the Novartis License Agreement).
Schedule 2.01(g) Other Purchased Assets
None.
Schedule 6.03(a) Elan Governmental Consents
1. EPI will be required to notify the FDA in writing of the transfer of the Product Registrations to Acquiror. EPI will so notify the FDA within five (5) Business Days after the date hereof.
2. In order for EPIs Affiliate Elan Pharma International Limited to perform its obligations under the Supply Agreement, each of IND 63-884 and NDA 21-447 will have to be in effect and are now and will be immediately after the Closing in full force and effect.
Schedule 6.03(b) Elan Third Party Consents
The Novartis License Agreement requires Novartis consent to assignment.
Schedule 6.05 Material Contracts
1. The Novartis License Agreement.
2. Rebate Agreement by and between Argus Health Systems, Inc. and EPI dated as of January 2, 2002 (the Argus Agreement).
3. Rebate Agreement by and between Coventry Health Care, Inc. and EPI dated as of January 1, 2001, as amended (the Coventry Agreement).
4. Rebate Agreement by and between Horizon Healthcare of New Jersey, Inc. and EPI dated as of January 1, 2001, as amended (the Horizon Agreement).
3
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
5. Rebate Agreement by and between Intermountain Health Care Health Plans, Inc. and EPI dated as of January 1, 2001, as amended (the Intermountain Agreement).
6. Agreement by and between Merck-Medco Managed Care, L.L.C. (as successor-in-interest to Merck-Medco Managed Care, Inc. and Managed Care LLC) and EPI (as successor-in-interest to Athena Neurosciences, Inc.) dated as of July 1, 1996, as amended (the Merck-Medco Agreement).
7. Rebate Agreement by and between Medimpact Healthcare Systems, Inc. and EPI dated as of April 1, 2002 (the Medimpact Agreement).
8. Rebate Agreement by and between Pharmacare Management Services, Inc. and EPI dated as of July 1, 2000 (the Pharmacare Agreement).
9. Rebate Agreement by and between Security Health Plan (Security Health) and EPI dated as of January 1, 2002 (the Security Health Agreement).
10. Safety Data Exchange Agreement between EPI and Novartis Pharma AG dated as of February 13, 2002.
11. Safety Data Exchange Agreement between EPI and Medeus Pharma Limited dated as of March 16, 2004.
12. Agreement by and among Glaxo Group Limited (Glaxo) and EPIs Affiliates Elan Corporation, plc (Elan) and Athena Neurosciences, Inc. (Athena) dated as of August 6, 1997 (the Glaxo Agreement).
13. Agreement between Pharmacia & Upjohn Company (Pharmacia) and Athena dated as of October 30, 1998 (the Pharmacia Agreement).
Schedule 6.07(a)(i) and (ii) Certain Contracts Relating to Product Intellectual Property
1. The Novartis License Agreement contains indemnification obligations of EPI that include claims relating to infringement of Purchased Intellectual Property. In addition, such agreements contain indemnification obligations of Novartis that include claims relating to Purchased Intellectual Property and that provide that Novartis shall have certain rights to control the defense of such claims.
2. The Argus Agreement contains indemnification obligations of EPI that include claims relating to infringement of Purchased Intellectual Property.
3. The Coventry Agreement contains indemnification obligations of EPI that include claims relating to infringement of Purchased Intellectual Property.
4
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
4. The Horizon Agreement contains indemnification obligations of EPI that include claims relating to infringement of Purchased Intellectual Property.
5. The Intermountain Agreement contains indemnification obligations of EPI that include claims relating to infringement of Purchased Intellectual Property.
6. The Medimpact Agreement contains indemnification obligations of EPI that include claims relating to infringement of Purchased Intellectual Property.
7. The Pharmacare Agreement contains indemnification obligations of EPI that include claims relating to infringement of Purchased Intellectual Property.
8. The Security Health Agreement contains indemnification obligations of EPI that include claims relating to infringement of Purchased Intellectual Property.
Schedule 6A7(a)(iv) Covenant Not to Sue Relating to Purchased Intellectual Property
In the Glaxo Agreement, Elan and Athena agreed not to object to Glaxos use or registration of the mark ZANTAC in certain circumstances.
Schedule 6.07(h) Certain Proceedings Relating to Product Intellectual Property
1. Petition for Cancellation of Registration No. 1,906,277 filed by Glaxo Group Limited, which was settled pursuant to the Glaxo Agreement.
2. Petition for Cancellation of Registration No. 1,906,277 and Notice of Opposition No. 108,684, each filed by Pharmacia and settled pursuant to the Pharmacia Agreement.
Schedule 6.08 Litigation
The events described in the MedWatch reports submitted to Acquiror in the dataroom for due diligence present bases for Actions or Proceedings relating to the Purchased Assets or the Business.
Schedule 6.09 Compliance with Law
1. Neither EPI nor any of its Affiliates makes any representations or warranties of any nature relating to promotional, marketing or training materials relating to the Products.
2. On February 23, 2004, EPI was notified by Novartis that Novartis failed to provide EPI adverse event reports from the period from July 1, 1999 through March 9, 2004. On April 7, 2004, EPI submitted to the FDA 139
5
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
MedWatch reports as prepared by Novartis, together with EPIs adjudication of each adverse event. These materials were submitted within the statutorily-required time period, but were not prepared by EPI. EPI did not submit, and has not been requested by the FDA to submit, a corrective action plan relating to these adverse events.
3. The annual report for NDA 20-397 was due on January 26, 2004 and has not yet been submitted.
4. As a result of the following article: Granfors MT. Backman JT. Neuvonen M. Ahonen J. Neuvonen PJ. Fluvoxamine drastically increases concentrations and effects of tizanidine: a potentially hazardous interaction. [Clinical Trial. Clinical Trial, Phase II. Journal Article. Randomized Controlled Trial] Clinical Pharmacology & Therapeutics. 75(4):331-41, 2004 Apr. (the Clinical Article), EPI has undertaken to amend EPIs Labeling for Zanaflex Tablets to include an additional precaution. EPI has also undertaken to update such Labeling to include certain information that was included in the combined Labeling that was approved for Zanaflex Tablets and Zanaflex Capsules. EPI shall not be obligated to continue such undertakings after the Closing, but the foregoing shall not reduce or otherwise affect EPIs retention of Excluded Liabilities or other covenants in the Agreement.
Schedule 6.11 Customers and Suppliers
Top 10 wholesale customers for the fiscal year ended December 31, 2003 for Zanaflex Tablets 2mg:
[***]
Top 10 wholesale customers for the fiscal year ended December 31, 2003 for Zanaflex Tablets 4mg:
[***]
6
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Supplier of active pharmaceutical ingredient:
Novartis
Schedule 6.12 Certain Governmental Permits
1. EPI is required to have wholesaler/distribution licenses in each state where the Products are sold. Such licenses have not been delivered to Acquiror.
2. NDA 20-397.
3. NDA 21-447.
4 IND 37-891.
5. IND 63-884.
6. IND 59-464.
7. On February 23, 2004, EPI was notified by Novartis that Novartis failed to provide EPI adverse event reports from the period from July 1, 1999 through March 9, 2004. On April 7, 2004, EPI submitted to the FDA 139 MedWatch reports as prepared by Novartis, together with EPIs ajudication of each adverse event. These materials were submitted within the statutorily-required time period, but were not prepared by EPI. EPI did not submit, and has not been requested by the FDA to submit, a corrective action plan relating to these adverse events.
8. The annual report for NDA 20-397 was due on January 26, 2004 and has not yet been submitted.
9. As a result of the Clinical Article, EPI has undertaken to amend EPIs Labeling for Zanaflex Tablets to include an additional precaution. EPI has also undertaken to update such Labeling to include certain information that was included in the combined Labeling that was approved for Zanaflex Tablets and Zanaflex Capsules. EPI shall not be obligated to continue such undertakings after the Closing, but the foregoing shall not reduce or otherwise affect EPIs retention of Excluded Liabilities or other covenants in the Agreement.
7
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Schedule 8.06 Multi-Product Contracts
1. The Argus Agreement.
2. The Coventry Agreement.
3. The Horizon Agreement.
4. The Intermountain Agreement.
5. The Merck-Medco Agreement.
6. The Medimpact Agreement.
7. The Pharmacare Agreement.
8. The Security Health Agreement.
9. EPIs contract with the Veterans Administration is also a Multi-Product Contract, but notwithstanding anything to the contrary contained in the Agreement or herein, such contract will not be terminated.
8
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Exhibit 6.13
[***]
9
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
ACQUIROR DISCLOSURE SCHEDULE
The following matters are disclosures made in connection with the representations and warranties of Acorda Therapeutics, Inc., a Delaware corporation (Acquiror), set forth in the Asset Purchase Agreement (the Agreement) by and between Elan Pharmaceuticals, Inc. (EPI) and Acquiror and delivered in connection with the execution and delivery of the Agreement by Acquiror. Section numbers used herein correspond to the section numbers in the Agreement; provided, however, that any information disclosed herein under a particular section number shall be deemed to be disclosed and incorporated into another section number contained herein if such information reasonably relates to the representation and warranty in the Agreement that corresponds to such other section number. Except as otherwise stated or the where the context indicates otherwise, all capitalized terms used herein shall have the meanings given them in the Agreement.
Nothing herein constitutes an admission against Acquirors interests. The inclusion of any item herein should not be interpreted as indicating that Acquiror has determined that such item or other matter is necessarily material to EPI. EPI acknowledges that certain information contained in this Acquiror Disclosure Schedule may constitute confidential information relating to Acquiror and/or its Affiliates, and therefore may be subject to the confidentiality provisions contained in the Agreement. Where the terms of disclosure items may have been summarized, disclosed or otherwise described in this Acquiror Disclosure Schedule, such summary, disclosure or description does not purport to be a complete statement of the material terms of such item.
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Schedule 7.03(a) Acquiror Governmental Consents
The following may or will be required by or with respect to the Acquiror in connection with the performance of its obligations under the Agreement, the Supply Agreement and the Related Agreements to which it is a party. Acquiror has begun evaluating and/or applying for the items listed below and will obtain each as necessary to perform its obligations under the Agreement, the Supply Agreement and the Related Agreements to which it is a party.
1. Licenses to do business in each of New York, Tennessee, California, Florida, and Louisiana.
2. Licenses to distribute prescription medication in the states where required.
3. License(s) to import pharmaceutical product from Canada (for Zanaflex tablets) and from Ireland (for Zanaflex capsules).
4. National Drug Code from the U.S. Food and Drug Administration.
5. NDA for Zanaflex tablets and capsules, to be transferred by EPI.
Schedule 7.03(b) Acquiror Third Party Consents
None.
2
Exhibit 10.27
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
ELAN PHARMA INTERNATIONAL LIMITED
AND
ACORDA THERAPEUTICS, INC,
ZANAFLEX SUPPLY AGREEMENT
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
THIS SUPPLY AGREEMENT (this Agreement ) is made on July 21, 2004 (the Effective Date )
BETWEEN:
(1) ELAN PHARMA INTERNATIONAL LIMITED, a company incorporated in Ireland (registered no. 222276) ( Elan ); and
(2) ACORDA THERAPEUTICS, INC. , a Delaware corporation whose registered office is at 15 Skyline Drive, Hawthorne, NY 10532 ( Buyer ).
RECITALS:
(A) Pursuant to that certain Asset Purchase Agreement between Buyer and Elan Pharmaceuticals, Inc. ( EPI ), dated July 21, 2004 (the Purchase Agreement ), Buyer acquired (among other assets) the rights and authorisations necessary to market and sell the Products (as defined below) in the Territory (as defined in the Asset Purchase Agreement).
(B) Elan has agreed to manufacture and supply the Products to Buyer, and Buyer has agreed to purchase the Products for onward commercial supply on the terms and conditions set out in this Agreement.
NOW IT IS HEREBY AGREED AS FOLLOWS:
Affected Item shall have the meaning given to such term in Clause 10.3;
Affected Obligation shall have the meaning given to such term in Clause 20.1;
Affected Party shall have the meaning given to such term in Clause 20.1;
Affiliate shall mean, with respect to any person or entity, any other person or entity which Controls, is Controlled by or is under common Control with such person or entity;
Alternate Manufacturer shall have the meaning given to such term in Clause 11.4;
Beneficiary shall have the meaning given to such term in Clause 13.8.2;
Business Day shall mean a day other than a Saturday or Sunday or public holiday in England and Wales, and Ireland;
cGMP shall mean current Good Manufacturing Practice under the applicable laws and regulations in the United States, Ireland and the European Union;
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Confidential Information shall have the meaning given to such term in Clause 15.1;
Control means (a) ownership (directly or indirectly) of at least fifty percent (50%) of the shares of stock entitled to vote for the election of directors in the case of a company or corporation; or (b) the ability (directly or indirectly) otherwise to direct and control the actions of a person or entity.
Covenantor shall have the meaning given to such term in Clause 13.8.2;
Disclosing Party shall have the meaning given to such term in Clause 17.1;
Due Date shall have the meaning given to such term in Clause 9.4;
Elans Facility shall mean Elans manufacturing facility located at Monksland, Athlone, Co. Westmeath, Ireland or Elans Affiliates manufacturing facility located at Gainesville, Georgia, U.S.A., or such other manufacturing facility as Elan may from time to time specify (provided that any facility so specified has received all required Facility Licences and Elan has provided Buyer with advance notice sufficient to amend its NDA to include such facility if Elan intends to use a facility other than the one located at Monksland, Athlone, described above);
Ex Works and EXW shall have the meaning as such term is defined in the ICC Incoterms, 2000, International Rules for the Interpretation of Trade Terms, ICC Publication No. 560;
Facility Licences means all required licenses, approvals, permits and authorizations required by any Governmental Authority or law or regulation to manufacture, package or store Products, or, to the extent required for Elan to perform under this Agreement, to ship or export Products;
Force Majeure Event means an event beyond the control of the Affected Party which makes the Affected Partys performance of an obligation impossible (or such an event that makes such performance so impractical as to be reasonably to be considered impossible) including, without limitation, strike, lock-out, labour dispute, act of God, war, armed conflict, terrorism, riot, civil commotion, malicious damage, explosion, earthquake, fire, flood, storm or other extraordinary adverse weather conditions.
Governmental Authority shall mean each governmental and regulatory body, agency, department or entity, whether or not located in the Territory, which regulates, directs or controls commerce in or with any territory or location;
shall mean the Irish consumer price index or such other index as may replace it from time to time; or if there is no replacement, such published Irish index as Elan in its discretion considers to be the closest comparator to the same;
Initial Term shall have the meaning given to such term in Clause 11.1;
2
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Knowledge of a particular fact or other matter means: (i) with respect to any individual; (A) the actual knowledge of such individual concerning such fact or other matter; and (B) the knowledge that a prudent individual would be expected to discover or otherwise become aware of in the course of conducting a reasonable investigation concerning the existence of such fact or other matter; and (ii) with respect to Elan or Buyer, the Knowledge concerning such fact or other matter of (1) the officers of such party, (2) the directors of such party, and (3) the senior managers of such party with responsibility for, or supervision of, the relevant matters; provided that under no circumstances shall Knowledge of Elan include any knowledge not actually known to such persons but imputed to such persons or Elan due to its or its Affiliates relationship with Novartis Pharma AG ( Novartis ) or its representatives; and provided, further, that none of such persons shall have any obligation as a result of entering into (or any provision of) this Agreement, the Purchase Agreement or any related Agreement to make any inquiries of Novartis or its representatives regarding any matter.
Loss shall mean any loss, liability, or cost (including reasonable attorneys fees and expenses) which is incurred by a party;
Medical Claim shall have the meaning given to such term in Clause 13.7;
Minor Deficiencies and Delays shall mean (i) shortfalls that are consistent with industry accepted standards, but not to exceed 10% of the amount ordered (ii) delays in delivery of the Products not exceeding 30 days from the delivery date or such other period of delay as may be agreed between the Parties;
Monthly Forecast Report shall have the meaning given to such term in Clause 4.1.1;
Production Licence shall have the meaning given to such term in Clause 11.4;
Products means pharmaceutical products containing tizanidine as their active pharmaceutical ingredients and having a multi-particulate capsule formulation currently approved by the FDA pursuant to NDA No. 21-447 to be marketed in the Territory.
Product Specifications shall mean the specifications for the Products contained in the relevant Regulatory Approvals issued by the authorities in the Territory, and such additional or amended specifications for such Products as may be effected under the terms of this Agreement;
Regulatory Application shall mean any application for a Regulatory Approval, which is filed in the Territory following the Effective Date, including any supplements or amendments thereto;
Regulatory Approval shall mean the final approval required from a governmental regulatory authority to market a Product in the Territory, and any other approval which is required to market or sell such Product or otherwise necessary for Buyer to perform under this Agreement or otherwise handle the Products;
3
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Relevant Claim shall have the meaning given to such term in Clause 13.8;
Renewal Term shall have the meaning given to such term in Clause 11.1;
Serious Failure to Supply shall mean that in a period of a calendar year, for reasons other than Force Majeure, a shortage of tizanidine caused by events or third parties not under the control of Elan, or the default of Buyer, Elan fails on at least two consecutive occasions to supply Buyers properly forecasted and ordered requirements of the Products in accordance with the terms of this Agreement, except for Minor Deficiencies and Delays, and the cumulative shortfall for such calendar year attributable to such failure(s) is at least 35% of the aggregate amount properly forecasted and ordered from Elan for delivery in such calendar year; provided that, for purposes of this definition the timely supply of Products that breach the representations and warranties made in Clause 13.2 (excluding such Products with nonlatent defects) will be deemed not to be a failure to supply Buyers properly forecasted and ordered requirements of the Products in accordance with the terms of this Agreement;
Specified Delivery Date shall have the meaning given to such term in Clause 4.3;
Technical Agreement shall have the meaning given to such term in Clause 3.9;
Technological Competitors shall mean those entities, including any entities that are subsidiaries or successors in interest to such entities, set out in Schedule 3;
Term shall mean the Initial Term plus any applicable Renewal Term;
Territory means the United States of America, its territories and possessions and the Commonwealth of Puerto Rico;
VAT means; (a) any tax imposed in compliance with the Sixth Directive of the Council of the European Economic Communities (77/388/EEC); and (b) any other tax of a similar fiscal nature, whether imposed in a member state of the European Union in substitution for or in addition to such tax, or imposed elsewhere;
VAT Amount shall have the meaning given to such term in Clause 10.2; and
$ and US$ shall mean United States Dollars.
4
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
5
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
An inspection under Clause 3.7.1 shall be limited to determining whether there is compliance with cGMP and other requirements of applicable law.
6
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
7
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
8
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Elan shall promptly implement any such changes at Buyers sole cost (such cost to include but not be limited to Elans internal and external costs relating to changes to artwork and labeling and changes to raw materials, intermediary products and components, in each case whether such costs are out-of-pocket costs or write-off charges (to the extent such write-off charges are actually incurred by Elan and Elan has attempted in good faith to avoid such write-off charges by making other use of the applicable materials, products or components); provided, that Elan shall provide Buyer with advance notice of such changes and the estimated costs thereof and Buyer shall have the opportunity to discuss with Elan any of such changes or costs prior to such changes being implemented for up to two (2) weeks after Buyer receives such notice; and, provided, further, that with respect to then-outstanding purchase orders submitted by Buyer pursuant to Clause 4.3, to the extent that applicable law or any Governmental or Regulatory Authority does not allow Elan to manufacture and deliver to Buyer, or Buyer to sell, Products ordered under such purchase orders, Elan shall be permitted to delay delivery of Products ordered thereunder for an amount of time equal to the actual delay in making the changes required by changes in Product Specifications caused by compliance with this Clause 6.1 (it being understood and agreed by Buyer that it shall accept Products ordered under such purchase orders despite such Products being manufactured to Product Specifications that do not reflect the changes required by this Clause 6.1, to the extent that applicable law or any Governmental or Regulatory Authority allows Elan to manufacture and deliver to Buyer, and Buyer to sell, such Products). Otherwise, changes shall only be made to the Product Specifications by agreement between the parties.
9
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Notwithstanding Clause 11.2.1, no cure period shall apply with respect to Products described in Clause 7.2 other than that set forth in Clause 7.2.1. Other than as expressly set forth elsewhere in this Agreement in Clause 13.6, and with respect to Serious Failures to Supply and Product recalls, Buyer shall have no remedies in respect of Elan having supplied Products that breach the representations and warranties made in Clause 13.2 other than as set out in this Clause 7.2.
the parties shall appoint an independent first-class laboratory or other appropriate, independent expert to undertake the relevant testing, and its findings shall be conclusive and binding upon the parties. If the parties fail to agree on the appointment of an independent first-class laboratory or expert, as appropriate, within thirty (30) days after the parties first discuss such appointment, the parties agree that an independent party designated by Elan and an independent party designated by Buyer shall together select a mutually-acceptable, appropriate, independent expert. Such independent expert shall undertake the relevant analysis and/or testing and report its findings within a reasonable time of
10
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
appointment, which findings shall be conclusive and binding upon the parties. All costs relating to this process shall be borne solely by the unsuccessful party.
it shall promptly give to the other party notice of the same with full details. Notwithstanding any dispute between the parties as to whether the Product complies with the Product Specifications, the recall shall commence but such dispute shall be resolved in accordance with Clause 7.3.
11
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
12
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Elan may increase the price of the Products by such amount as is necessary to recover the additional costs of supplying the Products. Elan shall ensure that, where the costs of active ingredients or other raw materials used to produce the Products increase by a percentage in excess of the percentage increase in the Index (as compared to the Effective Date), Elan and Buyer will meet to discuss potential alternative suppliers of such materials.
13
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
14
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
15
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
16
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
17
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
18
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
19
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
and in each case on the basis that the Covenantor shall indemnify the Beneficiary, and keep the Beneficiary indemnified, on demand against all reasonable costs incurred as a result of a request or nomination by the Covenantor;
20
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
To the extent that such information is Confidential Information, the disclosing party shall so inform the recipients and use reasonable endeavours to ensure that they are bound by appropriate restrictions as to confidentiality.
21
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
22
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
provided that if the Disclosing Party becomes legally required to make such announcement, public statement or disclosure hereunder, the Disclosing Party shall, to the extent practicable, give the other party prompt notice of such fact so as to enable the other party to seek a protective order or other appropriate remedy concerning any such announcement, public statement or disclosure. Notwithstanding the foregoing sentence, the Disclosing Party shall be entitled to make such announcement, public statement or disclosure regardless of whether the other party is in the process of seeking a protective order or other remedy, if the Disclosing Party believes it is required to do so pursuant to subclauses 17.1.1 or 17.1.2.
23
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
24
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
25
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
No amendment, modification or addition hereto shall be effective or binding on any party hereto unless set forth in writing and executed by a duly authorised representative of each party.
No waiver of any right under this Agreement shall be deemed effective unless contained in a written document signed by the party charged with such waiver, and no waiver of any breach or failure to perform shall be deemed to be a waiver of any future breach or failure to perform or of any other right arising under this Agreement.
26
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Address:
Elan
Pharma International Limited
WIL House, Shannon Business Park
Shannon
County Clare
Attention: Counsel
Fax: +353 902 92427
with a courtesy copy (receipt of which shall not constitute, notice) to each of:
Address:
Elan
Pharma International Limited
WIL House, Shannon Business Park
Shannon
County Clare
Attention: Company Secretary
Fax: +353 902 92427
and
Address:
Elan
Pharmaceuticals, Inc.
800 Gateway Boulevard
South San Francisco, CA 94080
Attention: Vice President, Legal Affairs
Fax: (650) 553-7165
Address:
Acorda
Therapeutics
Attention: General Counsel
Fax: (914) 347-4560
or to such other address(es) and fax numbers as may from time to time be notified by either party to the other in conformity herewith.
27
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
At the request of either party, the other party shall (and shall use reasonable efforts to procure that any necessary third parties shall) execute such documents, and do all acts and things as may reasonably be required subsequent to the signing of this Agreement for assuring to or vesting in the requesting party the full benefit of the terms hereof.
This Agreement may be executed by facsimile and 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.
Any payment due hereunder from either party may be set off against any payment owed hereunder to such party.
28
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
IN WITNESS WHEREOF the parties have executed this Agreement on the Effective Date.
SIGNED |
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/s/ William F. Daniel |
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for and on behalf of |
|
|
ELAN PHARMA INTERNATIONAL LIMITED |
|
|
Name: William F. Daniel |
|
|
Position: Director |
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|
|
|
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SIGNED |
|
|
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|
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/s/ Ron Cohen |
|
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for and on behalf of |
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ACORDA THERAPEUTICS, INC. |
|
|
Name: Ron Cohen |
|
|
Position: President and CEO |
|
29
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
SCHEDULE 1
PRODUCTS
Product |
|
Strength
|
|
Bottle Size
|
|
Price (per
|
|
Minimum Batch Size
|
|
Zanaflex capsules (finished) |
|
2 |
|
150 |
|
[***] |
|
[***] |
|
Zanaflex capsules (finished) |
|
4 |
|
150 |
|
[***] |
|
[***] |
|
Zanaflex capsules (finished) |
|
6 |
|
150 |
|
[***] |
|
[***] |
|
Product |
|
Strength
|
|
Unit Size
|
|
Price (per unit) |
|
Minimum Batch Size
|
|
Zanaflex capsules (bulk) |
|
|
|
|
|
[***] |
|
[***] |
|
30
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
SCHEDULE 2
TERMS OF THE PRODUCTION LICENCE
31
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
32
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
33
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
SCHEDULE 3
TECHNOLOGICAL COMPETITORS
[***]
34
Exhibit 10.28
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
ASSIGNMENT AND ASSUMPTION AGREEMENT
This Assignment and Assumption Agreement (this Agreement) is entered into this 21st day of July 2004, by and among Acorda Therapeutics, Inc. (Buyer), Elan Pharmaceuticals, Inc. (together with its affiliates, Elan), on behalf of itself and its affiliates, and Novartis Pharma AG (together with its affiliates, Novartis), on behalf of itself and its affiliates.
WHEREAS, Buyer and Elan have entered into that certain Asset Purchase Agreement dated as of July 21, 2004 (the Asset Purchase Agreement) for the sale by Elan to Buyer of certain assets, including certain rights of Elan under that certain License Agreement (the License Agreement) dated April 17, as amended, between Athena Neurosciences, Inc., the predecessor to the interest of Elan in the License Agreement, and Sandoz Pharma Ltd., the predecessor to the interest of Novartis in the License Agreement;
WHEREAS, under the terms of the Asset Purchase Agreement, Elan has agreed to assign to Buyer certain rights of Elan, and Buyer has agreed to assume certain liabilities and obligations of Elan, under or pursuant to the License Agreement, and the parties desire to effect other arrangements regarding the terms of the License Agreement;
WHEREAS, Elan has previously assigned to Medeus UK Limited (Medeus) certain rights under or pursuant to the License Agreement, and Medeus agreed to assume certain liabilities and obligations of Elan under or pursuant to the License Agreement (collectively, the Medeus Assignment); and
WHEREAS, Novartis desires to consent to such assignment and assumption, and the parties hereto desire to effect such other arrangements, in each case on the terms and conditions described herein.
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
2
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
1.11 Territory means the United States of America, its territories and possessions and the Commonwealth of Puerto Rico.
3
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
7.6 Prior to the execution of the Supply Agreements, Novartis shall supply Zanaflex Tablets to Buyer and Compound to Elan at the following prices (the Interim Supply Prices):
Product |
|
Price (US$) |
|
2 mg Zanaflex Tablet |
|
[***] |
|
4 mg Zanaflex Tablet |
|
[***] |
|
Compound |
|
[***] |
|
These Interim Supply Prices may be adjusted by Novartis before the Supply Agreements have been executed; provided that such adjusted Interim Supply Prices shall not be effective until Buyer (with respect to Zanaflex Tablets) or Elan (with respect to Compound) have been notified of such adjustments in writing; and, provided, further, that increases to such Interim Supply Prices shall be limited to the percentage increase in the Swiss consumer price index, as compared to the most recent price adjustment. The Supply Agreements shall stipulate price and price changes, if any, for the terms of the Supply Agreements.
8.3 The provisions of Sections 8.1 and 8.2 shall not apply to any materials previously approved by Novartis that are changed solely to add the name of a sublicensee and/or delete the name of Licensee.
Acorda Therapeutics
15 Skyline Drive
Hawthorne, NY 10532
Facsimile: 914-347-4560
Attention: General Counsel; and
4
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
any notices to be sent to Novartis pursuant to the notice provisions of the License Agreement shall be sent to Novartis as follows:
Novartis Pharma AG
Lichtstrasse 35
4002 Basel
Swizerland
Attention: Manager, BD&L Mature Products
Facsimile: 41 61 324 2322.
[SIGNATURE PAGE TO FOLLOW]
5
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the day and year first written above.
ACORDA THERAPEUTICS, INC. (on behalf of itself and its affiliates) |
|||
By: |
/s/ Ron Cohen |
|
|
Name: |
|
||
Title: |
|
||
|
|||
|
|||
ELAN PHARMACEUTICALS, INC. (on behalf of itself and its affiliates) |
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By: |
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||
Name: |
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||
Title: |
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||
|
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|
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NOVARTIS PHARMA AG (on behalf of itself and its affiliates) |
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By: |
/s/ Peter Hewes |
|
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Name: |
Peter B. Hewes |
||
Title: |
Mature Products BU |
||
|
WSJ-210.211 |
||
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Tel. 47225 |
||
|
|
||
|
|
||
By: |
/s/ Sheyenne Scriven-Jin |
|
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Name: |
Sheyenne Scriven-Jin |
||
Title: |
Senior Legal Counsel |
||
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Transplantation and |
||
|
Mature Products |
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the day and year first written above.
ACORDA THERAPEUTICS, INC. (on behalf of itself and its affiliates) |
|||||
By: |
|||||
Name: |
|||||
Title: |
|||||
|
|||||
|
|||||
ELAN PHARMACEUTICALS, INC. (on behalf of itself and its affiliates) |
|||||
By: |
/s/ |
Jack Laflin |
|
|
|
Name: |
Jack Laflin |
||||
Title: |
Executive Vice President, |
||||
|
Global Core Services |
||||
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|||||
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|||||
NOVARTIS PHARMA AG (on behalf of itself and its affiliates) |
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By: |
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||||
Name: |
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||||
Title: |
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||||
Exhibit 10.29
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
CONFIDENTIAL
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this Agreement), made the 17th day of April , 1991 by and between SANDOZ PHARMA LTD., a Swiss corporation having its principal place of business at Lichtstrasse 35, CH-4002 Basle, Switzerland (Sandoz Pharma) and ATHENA NEUROSCIENCES, INC. a Delaware corporation having its principal place of business at 800F Gateway Boulevard, South San Francisco, California (Licensee),
WITNESSETH:
Whereas Sandoz Pharma has developed a substance called Tizanidine, useful in the treatment of spasticity and/or spastic diseases and owns and/or controls certain Know-How (as hereinafter defined) and patent rights relating to Tizanidine;
Whereas Sandoz Pharma has certain processes, skills and techniques for galenical formulations containing Tizanidine;
Whereas Licensee desires to acquire from Sandoz Pharma a license to sell Tizanidine and certain other rights on the terms and conditions herein set forth;
Whereas Licensee desires to purchase from Sandoz Pharma finished pharmaceutical formulations containing Tizanidine for sale in the Territory; and
Whereas Licensee desires to clinically develop and market in the Territory finished pharmaceutical formulations containing Tizanidine as the sole active ingredient,
Now, Therefore , In consideration of the premises and the mutual covenants herein contained, it is mutually agreed as follows:
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
2
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Unless otherwise directed by Sandoz Pharma, the reference under license from Sandoz Pharma Ltd. or a similar reference mutually agreed upon shall be included on Product labels and promotional materials.
3
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
4
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
5
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
6
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
7
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
8
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
9
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
10
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Neither party shall be responsible to the other for any failure or delay in performing any of its obligations under this Agreement or for other non-performance hereof provided that such delay or non-performance is occasioned by a cause beyond the reasonable control and without fault or negligence of such party, including, but not limited to fire, flood, explosion, discontinuity in the supply of power, court order or governmental interference or act of God, and provided that such party will immediately inform the other party and that it will entirely perform its obligations immediately after the relevant cause has ceased its effect.
11
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
12
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
13
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Should one or several provisions of the Agreement be or become invalid, then the parties hereto shall substitute such invalid provisions by valid ones, which in their economic effect come so close to the invalid provisions that it can be reasonably assumed that the parties would have
14
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
contracted this Agreement with those new provisions. In case such provisions cannot be found, the invalidity of one or several provisions of the Agreement shall not affect the validity of the Agreement as a whole, unless the invalid provisions are of such essential importance for this Agreement that it is to be reasonably assumed that the parties would not have contracted this Agreement without the invalid provisions.
This Agreement shall be construed in accordance with the substantive laws of New Jersey.
This Agreement and the licenses granted herein shall not be assignable by either party hereto, except to a successor of all or substantially all of its pharmaceutical business, without the
15
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
consent in writing first obtained from the other party. Such non-authorized assignment shall be null and void. A merger, acquisition or sale of all or substantially all of the assets of a party to this agreement shall not be deemed to be an assignment requiring the consent of the other party hereto.
16
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first set forth above.
ATHENA NEUROSCIENCES |
|
|
|||||
|
|
|
|||||
By: |
/s/ Paulette E. Setler |
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|
||||
|
|
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|
||||
Title: |
Executive Vice President, Research |
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|
||||
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||||
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|||||
SANDOZ PHARMA LTD. |
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|||||
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|||||
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|
|||||
By: |
/s/ R. Wäger |
/s/ R.V. Tschannen |
|
|
|||
|
Dr. R. Wäger |
Dr. R. Tschannen |
|
|
|||
|
|
|
|||||
Title: |
Head of Manager of Licensing |
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|
||||
|
Product Policy |
|
|
||||
17
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Schedule I
to the Agreement by and between SANDOZ PHARMA and LICENSEE of
Description of Substance
|
Tizanidine - hydrochloride |
|
Chemical name: |
|
5-chloro-4(2-imidazoline-2yl-amino)-2, 1, 3-benzo-thiazole hydrochloride |
Appearance: |
|
white to yellowish white finely cristalline powder |
Loss of drying: |
|
Not more than 0.5 per cent |
Assay of Tizanidine base: |
|
98 - 102 per cent by titration |
Basel, |
April 12, 1991 |
|
South San Francisco, |
April 17, 1991 |
|
|
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|
|
|
|||
SANDOZ PHARMA LTD. |
ATHENA NEUROSCIENCES, INC. |
|||||
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|
|||||
/s/ R. Wäger-R.V. Tschannen |
|
/s/ Paulette E. Setler |
|
|||
18
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
A d d e n d u m
to the License Agreement, dated April 7th, 1991
between
Sandoz Pharma Ltd. , a Swiss corporation having its principal place of business at Lichtstrasse 35, CH-4002 Basel, Switzerland (hereinafter called Sandoz Pharma)
and
Athena Neurosciences, Inc. , a Delaware corporation having its principal business at 800F Gateway Boulevard, South San Francisco, California, U.S.A. (hereinafter called Athena).
The above mentioned Parties agree to amend Art. 1.11 and Art. 6.2 as follows:
1.11. Territory means the United States of America, its territories and possessions (including Puerto Rico) and Canada, as well as the United Kingdom and Ireland.
6.2. Athena, its Affiliates and its sublicensees shall pay Sandoz Pharma Supply Price (as defined in Section 7.7 of the above-mentioned Agreement) ninety (90) days from date of invoice and on such other reasonable terms and conditions as Sandoz Pharma ordinarily requires. However, for the initial two (2) pre-launch orders totaling [***], a credit period of one hundred and eighty (180) days instead of ninety (90) days from data of invoice is granted by Sandoz.
Basel, |
South San Francisco, |
||||
|
|
||||
February 17, 1995 |
|
February 24, 1995 |
|
||
(date) |
(date) |
||||
|
|
||||
SANDOZ PHARMA LTD. |
ATHENA NEUROSCIENCES, INC. |
||||
|
|
||||
|
|
|
|
||
/s/ P. Dufner |
/s/ R.V. Tschannen |
|
/s/ Lisabeth F. Murphy |
|
|
Dr. P. Dufner |
Dr. R. Tschanen |
|
Lisabeth F.
Murphy
|
||
19
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
April 12, 1991
SANDOZ
PHARMA
LTD.
Lichtstr 35
CH-4002 Basel SWITZERLAND
Gentlemen:
I am happy that we have now concluded the terms and conditions for Athena to acquire U.S. and Canadian Marketing rights to tizanidine.
As we discussed, there are a few points that are not practical to fully resolve at this time, and we agree to negotiate in good faith a final resolution of the following matters when required for marketing of the product:
(1) Sample Supply
Sandoz agrees to review Athenas sample needs to introduce and subsequently market tizanidine. Sandoz will use its good faith efforts to supply Athenas reasonable needs consistent with its own sampling policies.
(2) Final Form Packaging
Sandoz and Athena will discuss Athenas needs for final packaging forms and Sandoz agrees use its good faith efforts to supply these as close to the desired form as possible, providing Athena is prepared to accept final form packaging materials routinely used by Sandoz for tizanidine or other similar presentations.
(3) Patent Review
Sandoz and Athena agree to cooperate to permit Athena and its patent counsel to review any intellectual property protection that might be available for tizanidine prior to and during the period of Athenas marketing of this compound. Sandoz further agrees to use its good faith efforts to provide Athena license rights within the terms of the marketing agreement for any such protection which in Athenas judgment has commercial value.
Please acknowledge receipt of this letter by signing the enclosed copy and returning it to me.
Yours sincerely, |
|
|
|||||||||
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|
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|||||||||
/s/ |
|
|
|
||||||||
John Groom
|
|
Acknowledged and
received by:
|
|||||||||
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||||||||
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By: |
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/s/ |
|
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/s/ |
|
||||
|
Printed Name: |
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Dr. S. Strub |
|
Dr. R. Tschannen |
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|
||||
|
Title: |
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Manager Licensing |
|
Manager Licensing |
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|||||
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Date: |
|
May 3, 1991 |
|
May 3, 1991 |
|
|||||
20
Exhibit 10.32
AGREEMENT RELATING TO ADDITIONAL TRADEMARK
This Agreement Relating to Additional Trademark (this Agreement) is made as of July ___, 2005 (the Effective Date) by and between Elan Pharmaceuticals, Inc. (EPI) and Acorda Therapeutics, Inc. (Acorda). Capitalized terms not otherwise defined herein shall have the meanings ascribed to them in that certain Asset Purchase Agreement by and between EPI and Acorda dated as of July 21, 2004 (the Asset Purchase Agreement).
RECITALS
A. Acorda desires to utilize the trademark Zanaflex Capsules (the Mark) in connection with Zanaflex Capsules; and
B. The parties desire set forth rights and obligations relating to the Mark as set forth herein.
NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein and for good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the parties hereby agree as follows:
The Mark shall be and shall be deemed to be a Product Trademark for all purposes under the Asset Purchase Agreement, the Elan Disclosure Schedule and the Trademark License Agreement, and shall be subject to all of the rights and obligations of the parties relating to the Product Trademarks contained in such documents; provided that, notwithstanding the foregoing or anything to the contrary contained in such documents, none of the representations and warranties of EPI contained in Article VI of the Asset Purchase Agreement shall apply to the Mark.
Acorda hereby represents and warrants to EPI that any use by Acorda of the Mark will comply with all applicable Laws. Acorda agrees that for purposes of its indemnification obligations relating to Assumed Liabilities contained within Section 11.02(b)(iv) of the Asset Purchase Agreement, the use by Acorda or its Affiliates of the Mark in connection with the Products shall be deemed to be included within the operation of the Business by Acorda or its Affiliates after the Closing.
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
[REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK]
2
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written.
|
ELAN PHARMACEUTICALS, INC. |
|
|
|
|
|
By: |
/s/Joe Boudreau |
|
Name: |
Joe Boudreau |
|
Title: |
SVP |
|
|
|
|
ACORDA THERAPEUTICS, INC. |
|
|
|
|
|
By: |
/s/Ron Cohen |
|
Name: |
Ron Cohen |
|
Title: |
President & CEO |
3
Exhibit 10.38
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Fampridine
Tablets (10mg, 15mg, 20mg, 25mg)
Technical Transfer Program Proposal for
Commercial Registration
For
Acorda Therapeutics
Proposal No. ELN-FQ-0001-1002-R4
Dated: February 26, 2003
Confidential
TABLE OF CONTENTS
2
Patheon Proposal #
ELN-FQ-0001-1002-R4
29-Feb-03
1.0 Project Scope
Patheon Inc. (Patheon) will perform manufacturing and analytical services in order to manufacture Fampridine Tablets (10mg, 15mg, 20mg, 25mg) for Acorda Therapeutics (Client). Analytical methods will be assessed to support the manufacturing program.
The Budget Summary for this proposal is presented in Appendix A.
Patheon will commence the activities described in this proposal following the execution of the Contract by both parties.
Reference standards for Fampridine and impurities and tablet samples will be provided by the Client. Source technical documents (e.g., current Elan methods, validation reports, and master batch records, etc) and an HPLC column for initiation of method familiarization activities will be provided by the Client. Patheon will be responsible for the generation of documentation and protocols required to support methods familiarization, methods transfer, manufacturing studies, and process transfer activities to be performed as part of this proposal. The Client will review and approve all protocols generated by Patheon prior to execution of studies with the exception of the Clean Residuals Assay method. Patheon will provide final reports at key stages in the project, as indicated in this proposal. The Client will review and approve final reports.
2.0 Environmental , Health and Safety
Prior to the commencement of analytical method development, formulation development and manufacturing activities, a thorough review by Patheon of the Environmental, Health and Safety (EH&S) requirements for Fampridine will be completed. The fee assumes the EH&S review will determine that Fampridine can be safely handled at Patheon. A summary report for this evaluation will be provided to the Client.
Patheon will perform the required method familiarization, method transfer, method development and/or method validation work required to support the manufacture of Fampridine Tablets. Patheon is responsible for preparing all protocols. The Client will review and approve all protocols prior to execution of the work. Upon completion of individual studies, Patheon will prepare final reports to document results of all studies with the exception of the Clean Residuals Assay method. The Client will review and approve all reports before moving forward with activities that rely on results of the activities that are the subject of a report.
3
3.1 Cleaning Residuals Assay (Method Development and Validation)
Patheon will develop and validate the test methods required for testing cleaning residuals and swab samples in order to support the manufacturing program. Analytical protocols and report will be prepared by Patheon. The development and validation will challenge the following parameters:
System Suitability
Linearity
LOD
LOQ
Recovery / Accuracy
Repeatability
Intermediate Precision
Robustness
Specificity
Stability
3.2 Drug Substance Potency and Related Substance Assay (Method Transfer)
Patheon will transfer the test method required for drug substance testing in order to support the manufacturing program. The Client will supply Patheon in advance with the relevant Validation data to allow Patheon to set acceptance criteria for the protocol. Method Transfer protocols will be prepared by Patheon and submitted to the Client for approval prior to execution. A final report documenting the methods transfer results will be prepared by Patheon and submitted to the Client for approval prior to use of the method for release testing. The method transfer will challenge the following parameters:
System Suitability
LOD and LOQ
Specificity
Repeatability
Reproducibility
Robustness
3.3 Drug Substance Particle Size (Method Transfer)
Patheon will transfer the test method required for drug substance particle size testing in order to support the manufacturing program. The Client will supply Patheon in advance with the relevant Validation data to allow Patheon to set acceptance criteria for the protocol. Method Transfer protocols will be prepared by Patheon and submitted to the Client for approval prior to execution. A final report documenting the methods transfer results will be prepared by Patheon and submitted to the Client for approval prior to use of the method for release testing. The method transfer will challenge the following parameters:
Reproducibility
Robustness
Repeatability
4
3.4 Drug Substance Residual Solvent Assay (Method Verification)
Patheon will verify the test method required for drug substance residual solvent testing in order to support the manufacturing program. Analytical protocols will be prepared by Patheon and submitted to the Client for approval prior to execution. A final report documenting the method verification results will be prepared by Patheon and submitted to the Client for approval prior to use of the method for release testing. The method verification will evaluate the following parameters:
System Suitability
LOD and LOQ
Specificity
Repeatability
Reproducibility
3.5 Drug Substance Moisture by KF (Verification)
Patheon will verify the test method (up to 6 samples) required for drug substance moisture testing to ensure the method is precise and accurate in order to support the manufacturing program. Analytical protocols will be prepared by Patheon and submitted to the Client for approval prior to execution. A final report documenting the method verification results will be prepared by Patheon and submitted to the Client for approval prior to use of the method for release testing.
3.6 Drug Product Potency & Related Substance Assay, Two Methods (Method Transfer)
Patheon will perform method familiarization for the methods in advance of methods transfer. A report documenting the method familiarization results will be prepared by Patheon and submitted to the Client for approval prior to commencement of method transfer studies. The client will supply Patheon with the relevant validation data to allow Patheon to set acceptance criteria for the protocol
Patheon will transfer the test methods required for drug product potency and related substances testing in order to support the manufacturing program. It is noted that in addition to testing the coated finished product using Methods 1 and Method 2, a separate HPLC method will be used for the following:
content uniformity testing,
assay of the uncoated tablets
blend homogeneity testing.
Unit dose testing
Method Transfer protocols will be prepared by Patheon and submitted to the Client for approval prior to execution. Final reports documenting the method transfer results will be prepared by
5
Patheon and submitted to the Client for approval prior to use of the methods for testing. The transfer will challenge the following parameters:
System Suitability
LOD and LOQ
Specificity
Repeatability
Reproducibility
Robustness
3.7 Dissolution Assay (Method Validation)
Patheon will perform full validation of the method required for testing dissolution of the drug product in order to support the manufacturing program. Analytical protocols will be prepared by Patheon and submitted to the Client for approval prior to execution. A final report documenting the method validation results will be prepared by Patheon and submitted to the Client for approval prior to use of the method for release testing. The validation will be performed according to ICH guideline requirements typically:
System Suitability
Linearity & Range
Accuracy
Precision (Reproducibility)
Robustness of dissolution parameters & HPLC Methodology
Specificity
Solution Stability
3.8 Drug Product Moisture by KF (Verification)
Patheon will verify the test method (up to 6 samples) required for drug product moisture testing to ensure that the method is precise and accurate in order to support the manufacturing program. Analytical protocols will be prepared by Patheon and submitted to the Client for approval prior to execution. A final report documenting the method verification results will be prepared by Patheon and submitted to the Client for approval prior to use of the method for release testing.
3.9 Release Testing of the Drug Substance , per Lot
Patheon will test drug substance for receiving and releasing for manufacture as per Clients CoA or as specified by Client instruction.
Note
:
Release testing of the excipients and drug product has been included as
Analytical Support under each section of the manufacturing.
6
Patheon will manufacture up to three feasibility batches of Fampridine Tablets at the 10mg strength. These batches will be approximately 50 kilograms each and will not be manufactured back-to-back. A protocol to evaluate blend times, tablet press parameters and coating parameters will be prepared by Patheon and submitted to the Client for approval prior to execution of the feasibility study. The protocol will specify a detailed sampling plan and acceptance criteria.
All excipients will undergo complete analytical release testing in compliance with USP/NF (if the Client requires additional testing on the excipients, this will be addressed and costed separately as an amendment to this proposal). Patheon will prepare a master batch record(s), which will be provided to the Client for approval prior to manufacturing and specifies manufacturing procedures and acceptance criteria.
The feasibility batches will not be GMP batches and will not undergo a full QA review; the batches will be bulk packaged. A report documenting the results of the feasibility studies will be prepared by Patheon and submitted to the Client for approval prior to proceeding to the registration batch production phase of this proposal.
Feasibility Manufacturing Process Train (50 kilograms):
325L Gallay
Beta Press
Vector Lab Coater
Comil
The following in-process and finished product testing is based upon the described tests.
Blend Analysis
Blend Homogeneity / uniformity of dosage (total of 10 samples)
Composite sample Assay
Flow Properties
Bulk and Tap Densities (Including one sieve analysis)
Coated Tablet Analysis:
Appearance
Weight Variation
Potency & Related Substances
Identification
Dissolution Profile
Physical Parameters (hardness and friability)
Moisture (KF)
7
Uncoated Tablet Analysis:
Content Uniformity (As per USP)
Physical Parameters (Note Weight thickness and hardness will be evaluated as part of in-process monitoring these are performed as part of the process) hardness and friability
Appearance
Moisture (KF)
5.0 Registration Manufacturing
Patheon will manufacture twelve registration batches of Fampridine Tablets (three of each tablet strength) that are colored and debossed tablets. These batches will be approximately 50 kilograms each and may be manufactured back-to-back. Processing parameters will be based on recommendations from the feasibility study. All excipients will undergo complete analytical release testing in compliance with USP/NF (if the Client requires addition testing on the excipients, this will be addressed and costed separately as an amendment to this proposal). Patheon will prepare a protocol and provide the protocol to the Client for approval prior to execution of the registration batch production work. The protocol will specify a detailed sampling plan and acceptance criteria. Patheon will prepare master batch records, which will be provided to the Client for approval prior to manufacturing; the batch records will specify manufacturing procedures and acceptance criteria.
The registration batches will be manufactured in accordance with cGMPs and will undergo a full QA review by Patheon. The batches will be packaged as follows by Patheon (packaging configuration split to be determined by Client):
10mg Tablets |
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HDPE Bottles of 14s and 60s |
15mg Tablets |
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HDPE Bottles of 14s and 60s |
20mg Tablets |
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HDPE Bottles of 14s, 60s and 180s |
25mg Tablets |
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HDPE Bottles of 14s, 60s and 180s |
(all packaging configurations will include desiccant, filler and induction seal)
Registration Manufacturing Process Train (50 kilograms):
325L Gallay
Beta Press
Vector Lab Coater
Comil
8
The following in-process and finished product testing will be conducted.
Blend Analysis:
Blend Homogeneity/uniformity of dosage (total of 10 samples)
Composite sample assay, appearance, and ID
Flow Properties
Bulk and Tap Densities (Including one sieve analysis)
Coated Tablet Analysis:
Appearance
Potency & Related Substances
Identification
Dissolution Profile
Physical Parameters (hardness and friability)
Moisture (KF)
Uniformity of dosage
Uncoated Tablet Analysis:
Weight Variation
Physical Parameters (hardness, and friability)
Appearance ID
Moisture (KF)
Assay
Patheon will provide copies of executed batch records to the Client with the associated completed sampling protocol and summary of results. The Client will review the batch records prior to initiation of registration stability studies by Patheon.
For quoting purposes a non-matrix approach has been suggested to monitor the 30 lots (12 Registration batches, two packaging formats for the 10 and 15mg strengths, and three packaging formats for 20 and 25mg strengths of Fampridine Tablets) as per ICH guidelines.
Additional samples will be stored as contingency samples if required to generate data for long-term stability of the product.
The following storage conditions and test-points are suggested for testing:
1, 2, 3 and 6 months for 40 ° C ± 2 ° C / 75% ± 5% RH
1, 2, 3, 6, 9, and 12 months for 30 ° C ± 2 ° C / 60% ± 5% RH*
3, 6, 9, 12, 18, 24 and 36 months for 25 ° C ± 2 ° C / 60% ± 5% RH
Contingency samples at 5 ° C, Ambient RH*
(* Tested only if required due to significant changes in the next level condition)
9
The analytical data used for the release of each lot manufactured at Patheon will be considered as initial (T=0) data if samples are placed on stability within 30 days of batch release.
Cost efficiencies for analytical testing have been built into the stability program based upon the number of samples pulled in a given month. The fee for this stability program assumes that all lots will be placed on stability at the same time. If these lots are not placed on stability at the same time, the fee will be adjusted accordingly through an Amendment to Proposal. The number of Pulls and costing is based on the assumption that no testing is required at 30 ° C/60%RH.
Pullpoint Month |
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1 |
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2 |
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3 |
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6 |
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9 |
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12 |
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18 |
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24 |
|
36 |
Number of Samples Pulled |
|
30 |
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30 |
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60 |
|
60 |
|
30 |
|
30 |
|
30 |
|
30 |
|
30 |
Therefore, the stability sample breakdown is:
0 Single Sample Pullpoints (0 Samples)
0 Double Sample Pullpoints (0 Samples)
0 More Than Two Sample Pullpoints (0 Samples)
0 More Than Five Sample Pullpoints (330 Samples)
9 More Than Ten Sample Pullpoints (330 Samples)
The following standard tests are usually performed as part of the Stability Program:
Potency &Related Substances
Dissolution Profile
Physical Appearance
Moisture
Hardness
Friability
This estimate is based on a full ICH program. Patheon will prepare the ICH stability protocol. The protocol will be approved by the Client prior to initiation of the stability studies. Patheon will provide results to the Client for each test interval that has been reviewed by Patheon quality assurance. Patheon will prepare a report at the 3 and 6 month test stations and will prepare reports at every subsequent 6 month test station thereafter (or at each 12 month test interval, as appropriate, based upon the protocol).
There is the possibility to reduce the fees for this work based on the mutual agreement between Patheon and the Client to matrix the testing design. The final cost is to be determined.
Patheon will provide project management support to monitor the progress of the project against established timelines and will update the Client of changes in events. The project manager will coordinate regular biweekly teleconference meetings and quarterly face-to-face meetings. The fee for project management is incorporated in the breakdown of each activity.
10
8.0 Assumptions , Terms and Conditions
1. Development Activities : Patheon shall undertake and perform the product development work described in this Proposal (the Development Activities) which when accepted by CLIENT shall become a contract binding on Patheon and CLIENT (the Contract). Notwithstanding the foregoing, CLIENT and Patheon acknowledge that certain changes are contemplated in the scope of the Development Activities the details and costs of which will be negotiated at a later date. No changes, deletions or additions to the Development Activities will be considered valid without prior written agreement between CLIENT and Patheon. Patheon shall notify Client, in advance of incurring any costs, when additional development activities by Patheon, beyond the Development Activities set forth in this Proposal, become necessary due to unforeseen events. Patheon shall not perform any additional development activities without CLIENT approval of such related costs.
It is assumed that, based on the information available to Patheon at this time, Patheon can safely perform the Development Activities at its Toronto Region Operations facility. If it is determined by Patheons Environmental Health and Safety personnel that any of the active ingredients are a Category III or Category IV compound, an occupational exposure level, then an air sampling method will be required at CLIENTs expense prior to commercialization. Patheon reserves the right, in its sole and absolute discretion, to conduct an air sampling method on Category I and II compounds, at such price and upon such terms as may be mutually agreed to between the parties prior to commercialization.
1.1 Intellectual Property: includes, without limitation, rights in patents, patent applications, trade-marks, trade-mark applications, trade-names, confidential information, trade secrets, inventions, copyrights, industrial designs.
1.2 Grant of Non-Exclusive License to Patheon : The CLIENT hereby grants to Patheon, for the term of the Contract, a royalty-free, non-exclusive license to use Clients Intellectual Property for the performance of the Development Activities. The nonexclusive license granted herein shall be limited to Intellectual Property of the CLIENT that is necessary for the performance of the Development Activities and Patheon shall not use such Intellectual Property for any other purpose than performance of the Development Activities. The non-exclusive license shall not include any right not expressly stated hereunder. CLIENT represents and warrants that as of the date of the Contract to the best of its knowledge, without conducting any inquiry, that the Development Activities performed by Patheon will not, to the best of CLIENTs belief, infringe any Intellectual Property held by any third party.
2. Supply of Products :
(a) CLIENT shall supply Patheon with sufficient bulk quantities of the active ingredients and certain excipients for Patheons use in conducting the Development Activities under this Proposal. Such ingredients and excipients shall by supplied by CLIENT at its expense.
11
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
(b) Patheon shall purchase all other materials required to conduct the Development Activities. CLIENT shall pay Patheons direct cost thereof plus an additional [**] as a handling charge upon receipt of an invoice detailing such costs. Prior to making any such purchases in excess of [**], Patheon shall obtain CLIENT approval. In addition, Patheon shall obtain prior client approval for each and every purchase of other materials once the total amount invoiced to CLIENT during performance of the Development Activities exceeds [**].
3. Payment for Service :
(a) CLIENT shall pay Patheon for the services to be provided during the term of this Proposal in such amounts and in such manner as set forth in this Proposal. All amounts quoted are in USD funds and are valid for sixty (60) days from the date of this Proposal. All amounts quoted are subject to review by Patheon of all product specifications, development reports and, Environmental, Health and Safety assessment. One review with changes is included in the fee for final reports. Any additional changes shall be invoiced separately at the then prevailing hourly rates.
(b) Project specific items, which include but are not limited to special equipment, change parts, excipients, laboratory columns and reagents, tooling etc., obtained by Patheon from third party suppliers as well as services to be provided by any third party suppliers are subject to prior CLIENT approval, and will be billed back to CLIENT upon Patheons receipt of invoice from any supplier of Patheon. The purchase of project specific items and services are subject to the same prior approval requirements in Section 2 (b) of the Contract.
(c) Each Patheon invoice shall be due and payable within thirty (30) days of the date of such invoice.
4. Deposit : Prior to the commencement of any Development Activities by Patheon pursuant to this Proposal, Patheon shall have received from CLIENT a deposit in the amount set out in the Project Summary. This deposit amount will be held by Patheon as a deposit until the Development Activities, as modified from time to time, are fully completed or until this Contract expires or is terminated for whatever reason. The deposit amount shall be credited towards the final invoice for the Project. Patheon may apply this deposit amount against any accounts overdue in excess of 60 days of the date of the invoice. In addition, Patheon may, at its option, suspend all Development Activities until such time the outstanding amounts have been paid in full and the original deposit amount has been replenished.
5. Term and Termination : This Contract will take effect on the date of execution and shall continue until completion by Patheon of the Development Activities. Either party may terminate this Contract if the other party is in material breach of any provisions thereof and the breaching party fails to remedy any such breach within thirty (30) days of the notice of such breach by the non-breaching party. Additionally, CLIENT shall have the right to terminate this Contract immediately for any business reason.
In either such case, Patheon shall cease performance of the Development Activities upon termination and CLIENT shall pay to Patheon: (i) any fees and expenses due to Patheon for the
12
services rendered up to the date of termination; (ii) all actual costs incurred by Patheon to complete activities associated with the termination and close of the Project; and (iii) any additional costs incurred by Patheon in connection with the Project that are required to fulfill applicable regulatory and contractual requirements. Any re-scheduling of the Development Activities requested by CLIENT beyond one hundred twenty (120) days, notwithstanding a request made pursuant to Section 8.8, shall be deemed to be a termination.
All materials and supplies shall be picked up within five (5) business days of termination otherwise, a $20.00 per square foot per month surcharge will be assessed for storage.
6. Confidential Information : All proprietary or confidential information of either party that is disclosed or otherwise made known to the other party as a result of the Development Activities performed under this Contract shall be considered confidential property of the disclosing party (the Confidential Information). The Confidential Information shall be used by the receiving party, its employees and external advisors only for the purpose of performing the receiving partys obligations hereunder. For purposes of this paragraph, Confidential Information shall not be deemed to include any information that is (i) known to the receiving party at the time of the disclosure, as evidenced by its written records prior to disclosure by the disclosing party; (ii) is or becomes available publicly other than as a result of a breach of this Contract by the receiving party, (iii) obtained from a third party lawfully in possession of such information and under no obligation to maintain such information confidential or (iv) independently developed by the receiving party without use of the Confidential Information.
Each party agrees that it will not reveal, publish or otherwise disclose the Confidential Information of the other party to any third party without prior written consent of the disclosing party. However, disclosure of Confidential Information may be made if required by law or by any regulatory or governmental authority to which the receiving party or any of its respective affiliates may be subject, in each case, on prior written notice to the disclosing party, so that the disclosing party may determine whether to seek a protective order or other appropriate remedy. This obligation of confidentiality and non-disclosure shall remain in effect for a period of ten (10) years after the effective date of termination of this Contract.
7. Inventions, Etc. : All data, information and Intellectual Property generated or derived by Patheon as a result of Development Activities performed by Patheon under this Contract, to the extent it is specific to the development, manufacture, use and sale of the CLIENTs product the subject of the Development Activities (CLIENTs Product) shall be and remain the exclusive property of CLIENT. In addition, any data, information and Intellectual Property generated or derived by Patheon through the use of CLIENTs Intellectual Property that is not a result of the Development Activities performed by Patheon shall be the exclusive property of CLIENT. On the other hand, all data information and Intellectual Property generated or derived by Patheon as a result of Development Activities performed by Patheon under this Contract, which is not specific to the development the development, manufacture, use and sale of the CLIENTS product and has application beyond the CLIENTs Product shall be and remain the exclusive property of Patheon. Notwithstanding the foregoing, CLIENT acknowledges that Patheon possesses certain inventions, processes, know-how, trade secrets, other intellectual properties and other assets, including but not limited to, analytical methods, computer technical expertise and
13
software which have been independently developed by Patheon (collectively Patheon Property). CLIENT and Patheon agree that any Patheon Property or improvement thereto which are used, improved, modified or developed by Patheon under or during the term of this Contract, is the product of Patheons technical expertise possessed and developed by Patheon prior to or during performance of this Contract and are the sole and exclusive property of Patheon.
8. Errors and Omissions : In the event of a material error by Patheon in the performance of the Development Activities, CLIENT shall have the option to request Patheon to (1) repeat the service at Patheons own costs provided that CLIENT provides the active ingredient, or (2) reimburse CLIENT for the price for that particular service, excluding the cost of the active ingredient. In any event, Patheon shall not reimburse the amount of the active ingredient.
9. Indemnification :
(a) CLIENT shall defend, indemnify and hold harmless Patheon and its affiliates and their respective directors, officers, employees and agents (together with Patheon, the Patheon Indemnitees) from and against any and all claims, actions, causes of action, damages, liabilities, expenses including reasonable attorneys fees and expenses (collectively, Losses) to and in favour of third parties (other than affiliates) resulting from, relating to, or arising from: (i) any breach by CLIENT of any of its obligations under this Contract; and (ii) the Intellectual Property rights of third parties except to the extent such Losses are: (I) determined to have resulted from the negligence or willful misconduct of Patheon; or (2) for which Patheon is obligated to indemnify the CLIENT Indemnitees pursuant to Section 9(b).
(b) Patheon shall defend, indemnify and hold harmless CLIENT and its affiliates and their respective directors, officers, employees and agents (together with CLIENT, the CLIENT Indemnitees) from and against any and all Losses resulting from, relating to, or arising from any breach by Patheon of any of its obligations under this Contract except to the extent such Losses are: (i) determined to have resulted from negligence or willful misconduct of CLIENT; or (ii) for which CLIENT is obligated to indemnify the Patheon Indemnitees pursuant to Section 9(a).
(c) Under no circumstances whatsoever shall either party be liable to the other in contract, tort, negligence, or breach of statutory duty for any otherwise for any indirect or consequential damages.
10. Indemnification Procedures : In the event that either party seeks indemnification, it shall inform the other party of the claim as soon as reasonably practicable after it receives notice thereof and, shall permit the other party, at that partys cost, to assume direction and control of the defense of the claim, and shall cooperate as reasonably requested (at the expense of the other party), in defense of the claim. Neither party shall settle or otherwise compromise any claim or suit in any manner that adversely affects that other party hereunder or imposes obligations on the other party in addition to those set forth in this Contract, without prior written consent of the other party, which consent shall not be unreasonably withheld or delayed.
14
11. Miscellaneous : This Contract contains the entire understanding of the parties with respect to the subject matter herein and supersedes all previous agreements (oral and written), negotiations and discussions. The parties may modify or amend the provisions hereof only by an instrument in writing duly executed by both of the parties. Neither this Contract, nor any of either partys rights hereunder, may be assigned or otherwise transferred by either party without the prior written consent of the other party. Any attempt to assign the rights or obligations under this Contract shall be void. This Contract shall be deemed to be made in the State of New York and shall be interpreted and enforced in accordance with the laws of the State of New York, without regard to conflict of law principles. The parties hereby submit to the jurisdiction of the state and federal courts located within the State of New York. The obligation of the parties contained in Sections 6, 7, 8, 9 and 10 shall survive the expiration or earlier termination of this Contract.
Patheon and CLIENT have executed this Contract in duplicate by the duly authorized officers of each party.
Acorda Therapeutics |
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Patheon Inc. |
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By: |
/s/ Mitchell Katz |
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By: |
/s/ Nick A. DiPietro |
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Name: |
Mitchell Katz, PhD |
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Name: |
Nick A. DiPietro |
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Title: |
Vice President, Clinical Programs |
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Title: |
President & COO |
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Date: |
3/28/03 |
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Date: |
4/7/03 |
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15
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
THE FOLLOWING COSTS ARE ALL QUOTED IN: USD
16
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
5.0 REGISTRATION MANUFACTURING |
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ACTIVITY |
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SHIFTS |
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HOURS |
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PRICE |
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SHIFTS |
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HOURS |
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PRICE |
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Per Batch: |
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Manufacturing |
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[**] |
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[**] |
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[**] |
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Packaging |
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[**] |
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[**] |
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[**] |
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Analytical Support |
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[**] |
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[**] |
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Project Support |
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[**] |
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[**] |
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First Batch |
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[**] |
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[**] |
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[**] |
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11 |
Additional Batches Manufactured Back-to-Back from First Batch |
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Cost Savings Per Additional Batch: |
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3.5 |
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Shifts/ |
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[**] |
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Cost Per Additional Batch: |
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[**] |
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[**] |
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[**] |
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[**] |
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OPTIONAL: For 4 Registration Batches Manufacture Back-to-Back the Cost will be $249,820 |
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Bulk Hold Time Study (per Strength - one Timepoint) |
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[**] |
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[**] |
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TOTAL (Registration Manufacturing) |
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[**] |
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[**] |
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[**] |
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6.0 STABILITY - REGISTRATION |
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ACTIVITY |
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HOURS |
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PRICE |
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Number of Lots |
24 |
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Total Samples |
264 |
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Cost per Sample |
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# of Samples |
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Subtotal |
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Analytical Support (1 sample per pullpoint) |
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$ |
[**] |
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0 |
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$ |
0 |
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Analytical Support (2 samples per pullpoint) |
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$ |
[**] |
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0 |
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$ |
0 |
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Analytical Support (2+ samples per pullpoint) |
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$ |
[**] |
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0 |
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$ |
0 |
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Analytical Support (5+ samples per pullpoint) |
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$ |
[**] |
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0 |
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$ |
0 |
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Analytical Support (10+ samples per pullpoint) |
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$ |
[**] |
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[**] |
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[**] |
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TOTAL (Stability - Validation) |
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[**] |
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[**] |
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BUDGET TOTAL * |
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USD |
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[**] |
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Deposit |
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$ |
[**] |
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* The manufacturing cost given in this proposal is based upon the assumption that the drug substance is classified as a high potency material in accordance with Patheons Categorization System. If it is determined through Patheons Environmental Health and Safety Review that the drug substance is not categorized as a high potency material, the manufacturing cost will be revised through a Change of Scope to reflect handling charges for a low potency product.
17
Appendix
B: High Level Timeline
(2 pages)
The attached High Level Timeline is presented at this stage as a projected estimate of the duration and achievable milestones, based upon Patheons experience and history. The High Level Timeline should not be taken as part of an agreed legal deliverable of this proposal.
Once the project has been awarded to Patheon and the relevant legal documentation is in place, a revised Timeline detailing set milestones and duration of deliverables will be agreed upon between Patheon and the Client. The revised Timeline would likely have a similar duration and would be based upon resources and the availability of manufacturing time at the initiation of the project.
18
Exhibit 10.40
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
SYNDICATED SALES FORCE AGREEMENT
This SYNDICATED SALES FORCE AGREEMENT (Agreement) is dated as of August 1, 2005 (Effective Date) by and between Cardinal Health PTS, LLC (Cardinal Health) with a place of business at 7000 Cardinal Place, Dublin, Ohio, and Acorda Therapeutics, Inc. (Acorda), having a principal place of business at 15 Skyline Drive, Hawthorne, NY 10532.
Background Information
Acorda develops, distributes and sells pharmaceutical products, and Cardinal Health provides pharmaceutical representatives who Detail (as hereinafter defined) pharmaceutical products for third parties. Acorda desires Cardinal Health to provide representatives to Detail certain products as determined and directed by Acorda in the geographical territory hereinafter specified, pursuant to the terms and conditions of this Agreement, and Cardinal Health desires to provide the Representatives and perform such services pursuant to the terms and conditions set forth in this Agreement.
The parties hereby agree as follows:
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
2
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
3
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
4
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
5
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
6
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
7
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
8
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
9
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
10
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
11
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
12
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
The Product(s) shall be Detailed by Cardinal Healths Representatives under trademarks and logos owned by or licensed to Acorda or an Affiliate of Acorda. This Agreement does not constitute a grant to Cardinal Health of any license, property right or interest in the Product(s) or any materials comprising part of the Acorda Training Program, or any trademarks or other intellectual property right which Acorda or an Affiliate of Acorda owns or uses with respect to
13
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
the Product(s), the Acorda Training Program, or to the name or business style of Acorda. Cardinal Health and the Representatives shall use the Acorda Training Program materials and the Product Promotional Materials only for the purposes of this Agreement, and all copyright and other intellectual property rights in the Acorda Training Program materials and the Product Promotional Materials shall remain with Acorda.
14
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
All of the foregoing insurance policies shall cover claims on an occurrence basis and not on a claims made basis in order to assure that incidents occurring during the Term of this Agreement are covered under the policies even though the resulting claim is not brought until after this Agreement has expired or has been terminated.
15
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
16
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
17
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
18
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
19
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
20
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
21
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
22
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
23
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
24
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
25
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
26
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
All notices shall be addressed to:
If to Acorda, to:
Acorda Therapeutics, Inc.
15 Skyline Drive
Hawthorne, NY 10532
Fax: (914) 347-4560
Attention: Chief Operating Officer
If to Cardinal Health, to:
Cardinal Health
7000 Cardinal Place
Dublin, Ohio 43017
Fax: (614) 757-6000
Attention: Thomas Dimke
Senior Vice President, Contract Sales and Marketing Services
27
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
* * * * *
Signature Page Follows
28
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly authorized officers.
CARDINAL HEALTH PTS, LLC |
ACORDA THERAPEUTICS, INC. |
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By: |
/s/ Thomas G. Dimke |
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By: |
/s/ Mary Fisher |
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Name: |
Thomas G. Dimke |
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Name: |
Mary Fisher |
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Title: |
SVP & GM CHCSS |
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Title: |
COO |
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Date: |
September 15, 2005 |
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Date: |
September 15, 2005 |
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29
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Schedule 1.1(n)
List of Products
Zanaflex® Capsules
30
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Schedule 2.7
Form of Management Report
Report Name |
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Description |
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Frequency |
Territory Assignment Report |
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Lists the Representatives and Managers covering each region and Sub-Territory. If a Sub-Territory is vacant, the report will indicate the date when the Sub-Territory became vacant and what alternate coverage is being applied (i.e. District Manager, Adjacent Rep, etc.) In addition, the report will indicate the current turnover rate. |
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Monthly |
Territory Coverage Report |
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For each Sub-Territory, the report provides the call statistics: |
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Monthly and Quarterly |
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Percentage of call to Target Customers |
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Percentage of samples delivered to Target Customers |
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Average number of calls/day (calculated on a six month moving average). |
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The report is summarized at the Regional and National levels. |
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Sales Statistics Report |
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For each Sub-Territory, based on NDC Health Information Services data, the report will show: |
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Monthly and Quarterly |
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New Rx |
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Total Rx |
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Percent Change for New Rx |
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Percent Change for Total Rx |
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New Market Share Percent Change |
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Total Market Change Percent Change |
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Sales dollars per Sub-Territory |
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Percent change for sales dollars per Sub-Territory. |
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The report is summarized at the Regional and National levels. |
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Sample Inventory Report |
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For each Sub-Territory, the report will document all the sample distribution activities. The report will reflect the following: |
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Quarterly |
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For each SKU: |
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Period beginning balance |
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Total shipments received |
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Total samples dropped |
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Total samples returned to distributor |
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Total adjustments |
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Period ending balance |
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Total variance (units / percent) |
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The report is summarized at the Regional and National levels. |
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Sample Inventory Exception Report |
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The report will provide details on variances and adjustments related to the distribution of samples if any has occurred. |
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Quarterly |
31
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Schedule 3.1
Detail and Payment Schedule
Section 1. Detail Schedule :
Cardinal Health will deploy syndicated sales Representatives to deliver the agreed number of Exclusive Details at the agreed upon frequency to Acorda Target Customers.
Cardinal Health will deliver a minimum of 32,000 Exclusive Details per year for a period of two years based on the following schedule for Year One:
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Number of Exclusive Details |
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August, 2005 |
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2,666 Exclusive Details |
September, 2005 |
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2,666 Exclusive Details |
October, 2005 |
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2,666 Exclusive Details |
November, 2005 |
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2,666 Exclusive Details |
December, 2005 |
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2,666 Exclusive Details |
January, 2006 |
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2,666 Exclusive Details |
February, 2006 |
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2,666 Exclusive Details |
March, 2006 |
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2,666 Exclusive Details |
April, 2006 |
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2,666 Exclusive Details |
May, 2006 |
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2,666 Exclusive Details |
June, 2006 |
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2,666 Exclusive Details |
July, 2006 |
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2,666 Exclusive Details |
Section 2. Service Fees and Payment Schedule :
A. Service Fees. Except as otherwise expressly provided in Section 14.9 and Section 5 of this Schedule 3.1, Cardinal Healths sole compensation for providing the Details and the Services will be to receive fee payments from Acorda (the Service Fees) only if and to the extent Acordas annual Gross Sales (as defined below) for each of Year One and Year Two achieve a minimum of eighty-five percent (85%) of the annual Gross Sales forecasts (as described in this Schedule) for both such Years, as specified in advance in writing by the parties (the Annual Baseline Forecast) for each Contract Year of this Agreement, as set forth in Section 2(B) of this Schedule. Acorda shall pay the Service Fees due, if any, in accordance with Section 3 of this Schedule 3.1.
B. Annual and Periodic Baseline Forecasts . In order to provide for a periodic payment schedule of Service Fees for Cardinal Health, the Annual Baseline Forecast for each Contract Year will be divided into four unequal portions, each corresponding to a period (a Period) of a Contract Year (the Periodic Baseline Forecasts). The Annual Baseline Forecast and the Periodic Baseline Forecasts applicable to Year One of this Agreement are set forth below. The Annual Baseline Forecast and Periodic Baseline Forecasts for Year Two of the Agreement will be agreed by the parties in writing at least sixty (60) days prior to the start of Year Two, and those forecast numbers will become effective, along with any other agreed changes in targeting and number of Details to be delivered, upon the commencement of Year Two.
For the avoidance of doubt Gross Sales means total actual gross sales of the Product by Acorda, without any deductions, that are directly attributable to prescriptions for the Product written by Target Customers during the Term of this Agreement. To determine the value of each prescription to be credited to Cardinal Health, Acorda will apply Wholesale Acquisition Cost (WAC) pricing to Target Customer prescriptions. Prescription data will be based on syndicated third party data to be provided by NDC Health Information Services (Arizona) Inc. (NDC Health).
i Annual Baseline Forecast . The Annual Baseline Forecast for Year One is [* * *], and the amount of Service Fees that may be earned by Cardinal Health in respect of Gross Sales for Year One shall be calculated based upon the following table:
Gross Sales Achievement at End of Year One |
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Amount of Service Fees |
85-89.9% of Annual Baseline Forecast |
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[* * *] |
90-94.99% of Annual Baseline Forecast |
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[* * *] |
95-99.99% of Annual Baseline Forecast |
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[* * *] |
100-100.99% of Annual Baseline Forecast |
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[* * *] |
101-104.99% of Annual Baseline Forecast |
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[* * *] |
105-109.99% of Annual Baseline Forecast |
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[* * *] |
110-114.99% of Annual Baseline Forecast |
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[* * *] |
115-119.99% of Annual Baseline Forecast |
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[* * *] |
120-124.99% of Annual Baseline Forecast |
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[* * *] |
125-129.99% of Annual Baseline Forecast |
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[* * *] |
130-134.99% of Annual Baseline Forecast |
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[* * *] |
No Service Fees shall be earned by or payable to Cardinal Health in respect of Year One if Gross Sales for Year One are less than eighty-five percent (85%) of the Annual Baseline Forecast for Year One.
ii. Periodic Baseline Forecasts . The Periodic Baseline Forecasts for Year One have been allocated as follows:
Period One: August 1, 2005 - September 30, 2005: |
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[***] |
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Period Two: October 1, 2005 - December 31, 2005: |
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[***] |
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Period Three: January 1, 2006 - March 31, 2006: |
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[***] |
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Period Four: April 1, 2006- July 31, 2006: |
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[***] |
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Section 3. Services Fees and Interim Advances .
A. Earning Service Fees . Except as provided for in section 14.8, if the total Gross Sales for a Contract Year are less than eighty-five percent (85%) of the Annual Baseline Forecast, Acorda shall not owe Cardinal Health any Service Fees under this Agreement. If the total Gross Sales for a Contract Year are eighty-five percent (85%) or more of the Annual Baseline Forecast, Acorda shall pay Cardinal Health Service Fees in an amount agreed upon by the parties in writing based on total Gross Sales for a Contract Year as a percentage of the applicable Annual Baseline Forecast for such Year. The amount to be paid to Cardinal Health, if any, during the first Contract Year is set forth in Section 2(b)(i) of this Schedule 3.1. Cardinal Health acknowledges that achievement of individual Periodic Baseline Forecasts of Gross Sales shall not constitute satisfaction of the conditions required in order to earn Service Fees or a portion thereof. The Periodic Baseline Forecasts are used herein solely as interim milestones in order to permit Cardinal Health to receive interim advances from Acorda against potential future Service Fees that may be earned (the Interim Advances). Interim Advances, if payable, shall be paid up to three times within Year One (after the close of Periods One, Two and Three), and the amount of each Advance shall be determined as described in Section 3(B) below. For Year One, Cardinal Health will be eligible to receive Interim Advances after each of the first three Periods in Year One only if total Gross Sales aggregated from Program Launch to the close of such Period meet or exceed 85% of the Periodic Baseline Forecast for such Period.
B. Payment of Interim Advances and Final Payment . The amount of Interim Advance payable to Cardinal Health with respect to any Period during Year One shall be calculated as follows:
(i) calculate the aggregate Gross Sales for the Period (or Contract Year in the case of the final payment), based upon data provided by NDC Health (represented in the column labeled A on Schedule 1);
(ii) determine the percentage of Periodic Baseline Forecast (or Baseline Forecast in the case of the final payment) for the Period that such aggregate Gross Sales represent (Percentage Result, which is represented in the column labeled B on Schedule 1) ;
(iii) determine the total amount of Service Fee that would be payable if aggregate Gross Sales for the entire current Contract Year were equal to the same Percentage Result as for that Period (Annualized Payout, which is represented in the column labeled C on Schedule 1);
(iv) multiply the applicable Annualized Payout amount by twenty-five percent (0.25) (the Unadjusted Interim Amount amount for that Period, which is represented in the column labeled D on Schedule 1); and
(v) multiply the Unadjusted Interim Amount by seventy-five percent (0.75) (the Interim Advance, which is represented in the column labeled E on Schedule 1).
Each Interim Advance shall be paid within thirty days of receipt of invoice from Cardinal Health.
C. Interim Advance Payment Table . Attached hereto as Schedule 1 is an Interim Advance payment table that provides illustrations of Interim Advance calculations under various Gross Sales achievement scenarios, applying the calculation method set forth in the immediately preceding Section 3(B). Schedule 1 provides examples for illustration purposes only. For clarity, the 25% remaining from the Unadjusted Interim Amount after calculation of the Interim Advance in accordance with Section 3.B.(v), above, is represented in Schedule 1 as the Corporate Pool and will only be paid, if due, at the end of the Contract Year.
D. Calculation of Service Fees . Upon the completion of each Contract Year, Cardinal Health shall, in cooperation with Acorda, calculate the total Service Fees due for such Contract Year using the formula set forth in Section 3.B. of this Schedule 3.1, except that only steps (i) through (iii) of Section 3(B), above, shall be required. Acorda shall pay the total amount due, less any Interim Advances actually paid to Cardinal Health, within thirty days of receipt of an invoice from Cardinal Health for such amount. If the total Interim Advances actually paid to Cardinal Health during such Contract Year are greater than the amount actually due to Cardinal Health, Cardinal Health shall refund the overpayment to Acorda within thirty days of receipt of an invoice from Acorda for such amount.
E. No Year-on-Year Adjustments . There shall be no adjustments or carry-overs in respect of Gross Sales or Forecasts from Year One to Year Two under this Agreement.
F. No Additional Payments . Other than the Service Fees that may be earned as described above and the Direct Pass-Through Expenses described below, Acorda shall not be required to make any other payments of any kind to Cardinal Health in consideration of its services under this Agreement.
G. Field Pool . In each instance where Service Fee is paid to Cardinal Health hereunder, Cardinal Health shall reserve twelve and one-half percent (12.5%) of such amount for distribution as part of its quarterly bonus program among its Representatives and Managers. The allocation of such bonus reserve among the Representatives and Managers shall be decided solely by Cardinal Health, in its discretion.
Section 4. Summary of Services to be Provided by Cardinal Health . Set forth below is a summary of the services to be provided by Cardinal Health hereunder (collectively, the Services):
Detailing of the Product(s)
Recruitment for any turnover during Program for both sales Representatives and Managers
Payment of salary, bonus, payroll taxes, benefits, and fleet cars for sales Representatives and Managers.
Territory travel expenses for sales Representatives and Managers
Project management team that includes the following shared resources: national sales director, account executive, operations manager, human resources coordinator, Acorda services manager, information services manager, financial services manager, sales trainer and a help desk
Assist in Acorda Program Training and joint responsibility for POA meetings (including meeting planning & logistics, Program agenda and strategy)
Sole responsibility for Cardinal Health Training Requirements (including but not limited to selling skills training)
On-going Representative training (does not include Acorda Training Program T&E)
Call reporting
Data management & reporting services
Monthly reporting package and quarterly reviews
Project administration (supplies, postage and printing) & operational support
Sample storage, handling, management and distribution responsibilities
Collective sample requisition reports on behalf of all Representatives
Section 5. Direct Pass-Through Expenses of Acorda . The following are the sole expenses for which Acorda shall reimburse Cardinal Health under this Agreement. Such expenses shall be reimbursed whether or not Acorda owes Cardinal Health any Service Fees in accordance with the Agreement and this Schedule 3.1.
32
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Actual travel and meeting expenses for all required participation in any Acorda Training Program and subsequent POA meetings, including the Program launch meeting.
Cost of Additional Promotional Activities. To the extent Acorda hereafter approves additional Representative promotional activities for the Program, the parties will agree first in writing upon and manage a budget based upon promotional programs, per Section 2.3(i) of the Agreement.
Actual costs of sample storage, handling and distribution responsibilities
33
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Schedule 1
Interim Advance Payment Table
[to be attached]
34
Exhibit 10.41
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (the Agreement ) is made and entered into as of this 19th day of December, 2003 (the Effective Date ) among ACORDA THERAPEUTICS, INC., a corporation organized and existing under the laws of the state of Delaware having a principal place of business at 15 Skyline Drive, Hawthorne, New York 10532, USA ( Acorda ), CAMBRIDGE UNIVERSITY TECHNICAL SERVICES LIMITED, an entity organized and existing under the laws of England having a registered address at The Old Schools, Trinity Lane, Cambridge CB2 1TS, UK. ( CUTS ), and KINGS COLLEGE LONDON, an Institution incorporated by Royal Charter, of Strand, London, WC2R 2LS, UK ( KCL ; CUTS and KCL may be collectively referred to as the Institutions ). Each of Acorda, CUTS and KCL may be referred to herein individually as a Party and collectively as the Parties.
RECITALS
WHEREAS, CUTS is a wholly owned trading subsidiary of The Chancellor, Masters and Scholars of the University of Cambridge ( Cambridge ) and administers the granting of licenses on behalf of Cambridge;
WHEREAS, Professor James Fawcett of Cambridge, together with Professor Stephen McMahon and Dr. Elizabeth Bradbury of KCL, have developed technology described and claimed in the Patent Application (as defined in Section 1.17), and both Professor Fawcett and Cambridge have assigned to CUTS all of their intellectual property rights in the Patent Application, and all intellectual property rights in Professor McMahons and Dr. Bradburys inventions claimed in the Patent Application are owned by KCL;
WHEREAS, Institutions jointly own all right, title and interest in the international patent application entitled Materials and Methods for the Treatment of CNS Damage;
WHEREAS, Acorda desires to obtain and Institutions wish to grant to Acorda, an exclusive (except as otherwise provided in this Agreement), worldwide development and commercialization license under such international patent application and any patents owned or controlled by the Institutions that arise or derive from such international patent application, including all intellectual property rights therein, for the development and commercialization of pharmaceutical products for all purposes; and
WHEREAS, Acorda also wishes to collaborate with Cambridge and KCL to undertake a research project on the terms set out in a sponsored research agreement of even date.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants set forth below, and for other good and valuable consideration, receipt of which is hereby acknowledged, the Parties hereby agree as follows:
1
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
ARTICLE 1
DEFINITIONS
The following terms as used herein shall have the following meanings:
1.1 Active Ingredient means any compound or molecule, whether chemical or biological, that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect any structure or any function of the body of man or of animals. For the avoidance of doubt, this term includes those compounds or molecules that may undergo chemical change in the manufacture of a drug product and be present in such drug product in a modified form intended to furnish the specified activity or effect.
1.2 Affiliate means any corporation or non-corporate business entity which controls, is controlled by, or is under common control with Acorda. A corporation or non-corporate business entity shall be regarded as in control of another corporation if it owns, or directly or indirectly controls, at least fifty percent (50%) of the voting stock of the other corporation, or alternatively in either (a) the absence of the ownership of at least fifty percent (50%) of the voting stock of a corporation or (b) the case of a non-corporate business entity, or non-profit corporation, if it possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of such corporation or non-corporate business entity, as applicable.
1.3 Clinical Trial means any experiment in which a drug containing an Active Ingredient is administered or dispensed to, or used involving, one or more human subjects, except for the use of a marketed drug in the course of normal medical practice.
1.4 CNS means the central nervous system.
1.5 Control or Controlled means, with respect to a particular item of information or intellectual property right, that the particular Party (a) owns and has the ability to grant to another Party the licenses to such item as provided for herein, without violating the terms of an agreement with any Third Party, and/or (b) has a license to such item and has the ability to grant to another Party the licenses to such item provided for herein, without violating the terms of an agreement with any Third Party.
1.6 Dollars means United States dollars.
1.7 Earned Royalties means the royalties payable to Institutions by Acorda on Net Sales of Licensed Products by Acorda and/or its Affiliates as provided in Article 3.
1.8 FDA means the United States Food and Drug Administration or any successor entity.
1.9 IND means an investigational new drug application submitted to the FDA, which requests authorization from the FDA to administer an investigational drug or biological product to humans in the United States.
2
Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
1.10 Inventors means Professor James Fawcett, Professor Steve McMahon and Dr. Elizabeth Bradbury.
1.11 Licensed Enzyme Product means any pharmaceutical product containing or directly activating an enzyme, including but not limited to chondroitinase, to treat CNS disorders, diseases or injuries using the method covered by a Valid Claim in the Licensed Patents.
1.12 Licensed Patents means any or all of: (a) the Patent Application; (b) the substitutions, extensions, divisionals, continuations, or continuations-in-part of such Patent Application; (c) the patents issuing on any of the foregoing, including all re-examined or re-issued patents and extensions thereof; and (d) the foreign counterparts of any of the foregoing.
1.13 Licensed Product means either a Licensed Enzyme Product or a Licensed Small Molecule Inhibitor Product.
1.14 Licensed Small Molecule Inhibitor Product means any pharmaceutical product incorporating a small molecule inhibitor which is used to treat CNS disorders, diseases or injuries that is covered by a Valid Claim in the Licensed Patents.
1.15 Licensed Territory means the world.
1.16 Net Sales means the actual amounts invoiced by Acorda and/or its Affiliates for the Sale of Licensed Products to a Third Party purchaser without deduction of any commission paid to a Third Party purchaser but less the following deductions to the extent that such amounts are actually allowed or incurred with respect to such Sales: (a) freight, packaging and insurance costs incurred in transporting the Licensed Product to such customers; (b) quantity, cash and other trade discounts or rebates actually allowed and taken, including without limitation, discounts or rebates granted to managed health care organizations, or as mandated by any governmental agency or branch thereof in the Licensed Territory; (c) customs, duty, sales and other similar taxes; (d) governmental charges incurred in connection with the exportation or importation of such Licensed Products; (e) amounts repaid or credited by reason of rejections, return of goods, recalls or retroactive price reductions and (f) amounts written off in accordance with GAAP as uncollectable debts from the purchasers, not to exceed 4% of Net Sales in any particular royalty period, and provided, however that if such amounts so written off are later collected by Acorda and/or its Affiliates, then such amounts shall be deemed Net Sales and Acorda shall pay Institutions the applicable royalty on Net Sales in accordance with Sections 3.2 and 3.3. In any event, Acorda will use reasonable efforts to collect debts from its purchasers of Licensed Products. Sales of Licensed Products or granting of sublicenses by Acorda and its Affiliates to Third Parties shall be on an arms length basis and on a bona fide basis for the purpose of maximizing revenue.
1.17 Patent Application means the international patent application entitled Materials and Methods for the Treatment of CNS Damage, disclosing inventions by the Inventors, filed on the 4 th March 2003 having serial number PCT/GB2003/000901.
1.18 Payment Period means a semi-annual period ending 30 th June or 31 st December of each calendar year.
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
1.19 Phase I Clinical Trial means a Clinical Trial on sufficient numbers of normal volunteers and subjects that is designed to establish that a pharmaceutical product is safe for its intended use, and to support its continued testing in Phase II Clinical Trials.
1.20 Phase II Clinical Trial means a Clinical Trial on sufficient numbers of subjects that is designed to establish the safety and biological activity of a pharmaceutical product for its intended use, and to define warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed.
1.21 Phase III Clinical Trial means a Clinical Trial on sufficient numbers of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to define warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, and to support Regulatory Approval of such pharmaceutical product or label expansion of such pharmaceutical product.
1.22 Regulatory Approval means the approvals, registrations or authorizations of the Food and Drug Administration (FDA), or the equivalent regulatory agency in a foreign country or jurisdiction necessary for the manufacture, distribution, marketing and sale of a pharmaceutical or diagnostic product in the United States, or such foreign country or jurisdiction, as applicable.
1.23 Sale or Sold means the sale or other commercial disposition of a Licensed Product by Acorda, its Affiliates or sublicensees. In case of doubt, Sales of Licensed Products shall be deemed consummated no later than invoicing of payment to a Third Party for the applicable transaction involving such Licensed Product.
1.24 Sublicense Royalties means any royalty payments (which for clarity excludes any upfront payments, milestone payments, or any equity investments made in Acorda at fair market value (and provided further that if any equity investment is made at a premium to fair market value, the amount of such premium would be deemed Sublicense Royalties)) received by Acorda and/or its Affiliates from a Third Party sublicensee based on the Sublicense of Acordas and/or its Affiliates rights in the Licensed Patents.
1.25 Third Party means any entity or individual other than Acorda, Cambridge, CUTS or KCL, or an Affiliate.
1.26 Valid Claim means (a) a claim of any issued, unexpired patent included among the Licensed Patents, which patent claim has not been (i) held unenforceable, unpatentable or invalid by a decision of a court or governmental body of competent jurisdiction, which decision is not further appealable, or (ii) rendered unenforceable through reexamination, reissue, disclaimer or otherwise, or (iii) lost through an interference proceeding, or (iv) abandoned; or (b) a pending claim of an international patent application filed under the Patent Cooperation Treaty (the PCT ) included within the Licensed Patents, which claim (i) has been pending under examination for less than seven (7) years from date of filing of such claim, and (ii) has been asserted in good faith, and (iii) has not been abandoned or finally rejected without the possibility of appeal or re-filing.
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
ARTICLE 2
GRANT OF LICENSE
2.1 Licenses to Acorda.
(a) Subject to Section 2.2(a), Institutions hereby grant to Acorda and its Affiliates an exclusive (even as to the Institutions), royalty-bearing license, including (subject to the provisions of Section 2.3) the right to grant sublicenses, under the Licensed Patents to use and practice the inventions and information claimed or disclosed therein that relate to enzymatic methods of treating CNS disorder, disease or injury, and to research, develop, make, have made, use, sell, offer for sale, have sold, import, export, lease and otherwise exploit Licensed Enzyme Products for all purposes in the Licensed Territory during the term of this Agreement.
(b) Subject to Section 2.2(b), Institutions hereby grant to Acorda and its Affiliates a non-exclusive, royalty-bearing license, including (subject to the provisions of Sections 2.3 and 2.4) the right to grant sublicenses, under the Licensed Patents to use and practice the inventions and information claimed or disclosed therein that relate to small molecule inhibitors for use in treating CNS disorder, disease or injury, and to research, develop, make, have made, use, sell, offer for sale, have sold, import, export, lease and otherwise exploit Licensed Small Molecule Inhibitor Products for all purposes in the Licensed Territory during the term of this Agreement.
2.2 Retained Rights.
(a) The license granted in Section 2.l(a) above is subject to a right retained by the Institutions for their selves (and also grants to Cambridge and any wholly owned subsidiary of Cambridge and/or KCL) to use and practice the portions of the Licensed Patents relating to enzymatic methods of treating CNS disorders, diseases or injuries for non-commercial, academic research and educational purposes only. Such retained right shall be transferable to other academic institutions in the event that the Inventors become employed by such institutions, provided, however, that such other institutions right to use and practice such Licensed Patents shall be subject to the same limitations as those on the Institutions right to use and practice hereunder.
(b) The license granted in Section 2.1(b) above is subject to a right retained by the Institutions for their selves (and also grants to Cambridge and any wholly owned subsidiary of Cambridge and/or KCL) to use and practice the portions of the Licensed Patents relating to small molecule inhibitors for use in treating CNS disorders, diseases or injuries for all commercial and/or non-commercial purposes. Such retained right shall be transferable to other academic institutions in the event that the Inventors become employed by such institutions, provided, however, that such other institutions right to use and practice such Licensed Patents shall be subject to the same limitations as those on the Institutions right to use and practice hereunder.
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
2.3 Sublicenses. Acorda and its Affiliates shall have the right to grant sublicenses to Third Parties under any or all of their license rights in the Licensed Patents granted in Section 2.1, provided that:
(a) the pricing of all Licensed Products that may be sold by Acorda or its Affiliate to any such sublicensee shall be determined on an arms length basis and on a bona fide basis for the purpose of maximizing the revenue;
(b) each such sublicense shall include obligations on the sublicensee that are consistent with the obligations made on Acorda and its Affiliates and agents and sub-contractors under this Agreement (e.g., each such sublicense will include an obligation on the sublicensee to indemnify Acorda and its Affiliates for any losses resulting from claims brought by a third party arising in connection with any personal injury and property damage caused by the manufacture, testing, design, use, Sale or labeling of any Licensed Products by such sublicensee);
(c) each such sublicense shall be memorialized in a written agreement with the sublicensee, a copy of which agreement shall be delivered to each of the Institutions within sixty (60) days of said sublicense becoming effective;
(d) each such sublicense shall terminate automatically on the termination of this Agreement for any reason whatsoever and in such circumstances the Institutions shall grant the sublicensee a direct license to the same extent wherein the financial terms shall be substantially equivalent to those of the sublicense, with all payments due under such direct license being payable directly to the Institutions;
(e) each such sublicense shall provide that Acorda may terminate the sublicense if the sublicensee commences legal proceedings to challenge the validity of any of the Licensed Patents; and
(f) Acorda and its Affiliates shall use best endeavors to enforce all payment obligations contained in each such sublicense.
2.4 Acorda and its Affiliates (or its sublicensee, as applicable) may grant only one (1) sublicense under the Licensed Patents relating to small molecule inhibitors for use in treating CNS disorders, diseases or injuries in any given jurisdiction. For clarity, the one (1) sublicense in a given jurisdiction may be a sublicense granted by another sublicensee hereunder.
2.5 No Implied License. The licenses and rights granted in this Agreement shall not be construed to confer any rights upon Acorda and its Affiliates by implication, estoppel, or otherwise as to any technology not specifically identified in this Agreement as Licensed Patents.
ARTICLE 3
COMPENSATION
3.1 Upfront Payment. Within ten (10) days of the Effective Date, Acorda shall pay Institutions an upfront license fee in the amount of [***].
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
3.2 Royalties on Licensed Enzyme Products. Subject to Sections 3.2(a) and 3.4, Acorda shall pay the Institutions royalties in the amount of two and one-half percent (2.5%) of the aggregate Net Sales of Licensed Enzyme Products made by Acorda and/or its Affiliates in countries in the Licensed Territory where such sales are covered by a Valid Claim in an issued patent in the Licensed Patents.
(a) Royalty Rate Adjustment. If licenses to dominant Third Party patents (that is, patents that claim the Licensed Enzyme Product or its manufacture or use) are required for Acorda or its Affiliates to research, develop, make, have made, use, sell, offer for sale, have sold, import, export, lease and otherwise exploit Licensed Enzyme Products in the Licensed Territory, Acorda may deduct, from the royalty amount payable by Acorda to Institutions, up to [***] of the royalty amounts owed the Third Party under such licenses, provided that in no event shall Institutions receive less than [***] of the aggregate Net Sales of Licensed Enzyme Products Sold by Acorda and/or its Affiliates in the Licensed Territory.
(b) Royalties on Sublicenses. Subject to Section 3.5, if Acorda and/or its Affiliates grants a sublicense under any or all of its rights in the Licensed Patents to a Third Party to research, develop, make, have made, use, sell, offer for sale, have sold, import, export, lease and otherwise exploit Licensed Enzyme Products, then Acorda will pay Institutions a percentage of all Sublicense Royalties received by Acorda and/or its Affiliates from such Third Party sublicensee based on such sublicense, according to the following schedule:
(i) If Acorda and/or its Affiliates grants such sublicense prior to filing an IND for any Licensed Enzyme Product, [***] of Sublicense Royalties;
(ii) If Acorda and/or its Affiliates grants such sublicense after filing an IND for any Licensed Enzyme Product but prior to commencing a Phase II Clinical Trial for any Licensed Enzyme Product, [***] of Sublicense Royalties;
(iii) If Acorda and/or its Affiliates grants such sublicense after commencing a Phase II Clinical Trial for any Licensed Enzyme Product but prior to commencing a Phase III Clinical Trial for any Licensed Enzyme Product, [***] of Sublicense Royalties;
(iv) If Acorda and/or its Affiliates grants such sublicense after commencing a Phase III Clinical Trial for any Licensed Enzyme Product but prior to Regulatory Approval of any Licensed Enzyme Product, [***] of Sublicense Royalties; and
(v) If Acorda and/or its Affiliates grants such sublicense after Regulatory Approval of any Licensed Enzyme Product, [***] of Sublicense Royalties.
For purposes of this Section 3.2(b) and Section 3.3(a), commencing a Clinical Trial shall mean administration of the first dose of a Licensed Product to a subject.
3.3 Royalties on Licensed Small Molecule Inhibitor Products. Subject to Section 3.4, Acorda shall pay Institutions royalties in the amount of one-half percent (0.5%) of the
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
aggregate Net Sales of Licensed Small Molecule Products by Acorda and/or its Affiliates in countries in the Licensed Territory where such sales are covered by a Valid Claim in an issued patent in the Licensed Patents.
(a) Royalties on Sublicenses. Subject to Section 3.5, if Acorda and/or its Affiliates grants a sublicense under any or all of their rights in the Licensed Patents to a Third Party to research, develop, make, have made, use, sell, offer for sale, have sold, import, export, lease and otherwise exploit Licensed Small Molecule Inhibitor Products, then Acorda will pay Institutions a percentage of all Sublicense Royalties received by Acorda and/or its Affiliates from such Third Party sublicensee based on such sublicense, according to the following schedule:
(i) If Acorda and/or its Affiliates grants such sublicense prior to filing an IND for any Licensed Small Molecule Inhibitor Product, [***] of Sublicense Royalties;
(ii) If Acorda and/or its Affiliates grants such sublicense after filing an IND for any Licensed Small Molecule Inhibitor Product but prior to commencing a Phase II Clinical Trial for any Licensed Small Molecule Inhibitor Product, [***] of Sublicense Royalties;
(iii) If Acorda and/or its Affiliates grants such sublicense after commencing a Phase II Clinical Trial for any Licensed Small Molecule Inhibitor Product but prior to commencing Phase III Clinical Trials for any Licensed Small Molecule Inhibitor Product, [***] of Sublicense Royalties;
(iv) If Acorda and/or its Affiliates grants such sublicense after commencing Phase III Clinical Trials for any Licensed Small Molecule Inhibitor Product but prior to Regulatory Approval of any Licensed Small Molecule Inhibitor Product, [***] of Sublicense Royalties; and
(v) If Acorda and/or its Affiliates grants such sublicense after Regulatory Approval of any Licensed Small Molecule Inhibitor Product, [***] of Sublicense Royalties.
3.4 Royalties on Combination Licensed Products. In the event a Licensed Product is sold in the form of a combination product containing one or more Active Ingredients in addition to the Licensed Product Active Ingredient (hereinafter Combination Licensed Product ) in countries in the Licensed Territory where such sales are covered by a Valid Claim in an issued patent in the Licensed Patents, then Net Sales for such Combination Licensed Product, for purposes of calculating Earned Royalties due hereunder on Net Sales of Licensed Enzyme Products and Licensed Small Molecule Inhibitor Products (as applicable) by Acorda, will be adjusted by multiplying actual Net Sales of such Combination Licensed Product by the applicable fraction, which will be negotiated in good faith by the Parties with the intention of agreeing upon a fair and equitable formula that reasonably reflects the relative value contributed by the Licensed Product to the total value of the combination in the Combination Licensed Product, as compared to the other Active Ingredients therein. Each Party shall share with the
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
other Parties any information in its possession that is relevant for determining such relative value.
3.5 Sublicense Limitation . Acorda and/or its Affiliates agree to use good faith efforts to avoid an economic arrangement in the deals with their sublicensees that provide for [***]. For the avoidance of doubt any sublicenses executed by Acorda and/or its Affiliates relating to the Licensed Patents may be compared against similar stage and economic sector deals at a similar point in time and involving similar technology to determine if [***]. In addition, Acorda and/or its Affiliates shall not enter into cross-license arrangements with any Third Party sublicensee under the Licensed Patents whereby [***]. For clarity, cross-licenses received by Acorda and/or its Affiliates in the typical course of partnering transactions where each partner to the transaction grants the other partner a cross-license to enable each other to conduct collaborative in-house research and development [***]. For further clarity, grants of covenants not to sue under patent rights shall be deemed to be licenses or sublicenses, as appropriate, under this Section.
3.6 Milestone Payments . Acorda shall pay Institutions milestone payments in the amounts specified below no later than thirty (30) days after the occurrence of each milestone as described below. Acorda shall pay the specified milestone payment upon the achievement of the corresponding milestone event by Acorda, its Affiliate or sublicensee.
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. |
|
[***] |
|
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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 clarity, in no event shall any milestone payment, except for the Indication Milestone, be paid more than once to Institutions pursuant to this Section 3.6. As used herein, successful completion of a Clinical Trial means that the complete, analyzed data and results from such Clinical Trial have met or exceeded the endpoints of the trial and support proceeding on to the next phase of Clinical Trials on the applicable Licensed Product.
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
ARTICLE 4
REPORTS, PAYMENTS AND ACCOUNTING
4.1 Royalties Reports and Records. During the term of this Agreement, Acorda shall furnish, or cause to be furnished to the Institutions, written reports for each of Acorda and its Affiliates showing, for each fiscal quarter during the applicable Payment Period, the applicable information as follows:
(a) the gross sales of all Licensed Products Sold by Acorda and its Affiliates in the Licensed Territory during the reporting period, together with the calculations of Net Sales in accordance with Section 1.16;
(b) the Earned Royalties payable in Dollars, together with the calculations thereof, which shall have accrued hereunder in respect to such Net Sales;
(c) the Sublicense Royalties received by Acorda and the portion of such Sublicense Royalties payable to the Institutions in accordance with Sections 3.2(b) and 3.3(a), as applicable;
(d) the exchange rates, if any, in determining the amount of Dollars payable to the Institutions; and
(e) the occurrence of any event triggering a milestone payment obligation in accordance with Section 3.6.
Such reports shall be substantially in the form of the template as given in Schedule 1 Part A and shall be due to Institutions within thirty (30) days after the close of the second Acorda fiscal quarter in the applicable Payment Period. Each such report shall: (a) contain a statement in substantially the form I hereby represent and warrant that this report is true and correct to the best of my knowledge and belief and; (b) be signed by an officer of Acorda. Acorda shall keep accurate records in sufficient detail to enable Earned Royalties, Sublicense Royalties and other payments payable hereunder to be determined, such records to include without limitation the amounts and source of any deductions made pursuant to Section 3.2(a). Acorda shall be responsible for all Earned Royalties, Sublicense Royalties and other payments that are due
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Institutions from Acordas Affiliates and have not been paid by such Affiliates. If a report required pursuant to this Section 4.1 is not submitted to the Institutions by the applicable due date, Institutions may give Acorda notice of such failure, and if Acorda does not provide such report within thirty (30) days of such notice, then Acorda shall pay to the Institutions the amount of one thousand dollars ($1,000) for each calendar month after such notice that such report remains undelivered.
4.2 Payee Designation. All payments made pursuant to Article 3 of this Agreement to be made to Institutions by Acorda (and/or its Affiliates) under this Agreement shall be paid by telegraphic transfer to the account of Cambridge University Technical Services Ltd at Barclays Bank of Benet Street, Business Centre, PO Box No 2, Cambridge CB2 3PZ, sort code 20-17-19 account number 90532215. The Parties agree that payments made by Acorda and/or its Affiliates and received by CUTS shall satisfy Acordas payment obligations to the Institutions hereunder.
4.3 Payment Terms. All payments made pursuant to Article 3 of this Agreement shall be made in accordance with Schedule 1 Part B. Each report pursuant to Section 4.1 shall be accompanied by payment to CUTS of the Earned Royalties, Sublicense Royalties or other payments due hereunder (as applicable) shown by said report to be due to the Institutions.
4.4 Non-Payment Terms. All payments made pursuant to Article 3 of this Agreement shall be made within thirty (30) days after the close of the second Acorda fiscal quarter in the applicable Payment Period, failing which the Institutions may charge interest on any outstanding amount on a daily basis at 3% above Barclays Bank plc base lending rate then in force. All payments due pursuant to Article 3 of this Agreement shall be made without deduction of income tax or other taxes charges or duties. Payments due between the end of the final Payment Period and termination or expiry of this Agreement shall be paid within thirty (30) days of said termination or expiry.
4.5 Right to Audit. Upon prior written notice to Acorda and not more than once in each Acorda fiscal year, the Institutions shall have the right to engage an independent, nationally-certified auditing firm selected by the Institutions and acceptable to Acorda, which acceptance shall not be unreasonably withheld, to have access during normal business hours of Acorda and on reasonable advance notice, to the applicable books and records of Acorda, as may be reasonably necessary to verify the accuracy of the royalty reports required to be furnished by Acorda pursuant to Section 4.1 of this Agreement. If such audit shows any underpayment of Earned Royalties or Sublicense Royalties by Acorda, then, within thirty (30) days after Acordas receipt of such report, Acorda shall remit or shall cause its Affiliates to remit to the Institutions:
(a) the amount of such underpayment; and
(b) if such underpayment exceeds five percent (5%) of the total Earned Royalties and/or Sublicense Royalties owed for the fiscal year then being reviewed, the reasonably necessary fees and expenses of such auditing firm performing the audit. Otherwise, such fees and expenses shall be borne solely by Institutions. Any overpayment of Earned Royalties and/or Sublicense Royalties shall be fully creditable against future Earned Royalties and/or Sublicense Royalties payable in any subsequent Payment Period.
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
4.6 Confidentiality of Records. All information provided by Acorda, or subject to review under this Article 4, shall be deemed Acordas Confidential Information (as defined in Section 9.1). The independent, nationally-certified auditing firm shall not disclose to the Institutions or to any Third Party any such Confidential Information, except for any information showing a discrepancy in amount owed to the Institutions, and the Institutions shall not use or disclose any such Confidential Information for any purpose other than determining and enforcing its rights under this Agreement.
4.7 Currency Restrictions. Except as otherwise provided hereinafter in this Section 4.7, all Earned Royalties and Sublicense Royalties shall be paid in Dollars. If, at any time, legal or other restrictions imposed by a government or governmental agency or established by a court of competent jurisdiction in a particular country, prevent the prompt remittance and conversion into Dollars of part of or all Earned Royalties and/or Sublicense Royalties with respect to Sales of Licensed Products in such country, Acorda and/or its Affiliates shall have the right and option to make such payments by depositing the amount thereof in local currency to the Institutions account in a bank or depository in such country.
ARTICLE 5
DEVELOPMENT RESPONSIBILITIES; DILIGENCE
5.1 Institutions Responsibilities: During the term of this Agreement, each of CUTS and KCL (or their designates) shall:
(a) transfer to Acorda all relevant and material information and data (except grant applications) in its possession and generated by the Inventors directly relating to the inventions claimed in the Licensed Patents, except to the extent such transfer is prevented by confidentiality obligations or other limitations pursuant to agreements or understandings between each of CUTS and KCL, respectively, and a Third Party, and Acorda shall have the right to use such information and data for the protection and exploitation of the Licensed Patents, including but not limited to the development and commercialization of products covered by the Licensed Patents, in accordance with its rights under the Agreement; and
(b) have the right to review and comment on the design and implementation of any Clinical Trial to be performed by Acorda and/or its Affiliates relating to any Licensed Enzyme Product or Licensed Small Molecule Inhibitor Product, provided that Institutions shall be bound by typical confidentiality restrictions with respect to any information disclosed by Acorda relating thereto.
5.2 Acorda Responsibilities. During the term of this Agreement, Acorda and/or its Affiliates shall:
(a) subject to 12.7, give credit to the Institutions (or their designees) for co-authorship of any publications by Acorda and/or its Affiliates relating to the Licensed Patents and acknowledge the efforts of each of Cambridge, CUTS and KCL in creating the Licensed Patents; and
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
(b) be solely responsible for their own expenses incurred in connection with their research and development efforts relating to the Licensed Patents.
5.3 General Diligence Obligations.
(a) Licensed Patents. Acorda shall use commercially reasonable efforts to conduct further research relating to Licensed Patents from time to time to evaluate their scientific and commercial utility.
(b) Licensed Products. Acorda shall, either through its own efforts and/or those of its Affiliates, use commercially reasonable efforts to develop and commercialize, and/or sublicense for development and commercialization, Licensed Enzyme Products and Licensed Small Molecule Inhibitor Products (subject to the limitation on sublicensing in Section 2.4 with respect to Small Molecule Inhibitor Products) as it deems appropriate, in the exercise of its business judgment.
(c) Share of Information. Acorda and/or its Affiliates shall share with the Institutions and Cambridge information developed through the research efforts of Acorda and/or its Affiliates relating to the Licensed Patents, except to the extent disclosure is prevented by confidentiality obligations of an agreement between Acorda and/or its Affiliates and a Third Party.
5.4 Specific Diligence Obligations.
(a) Acorda shall, either through its own efforts and/or those of its Affiliates or sublicensees, use commercially reasonable efforts to develop and commercialize Licensed Products by performing the following actions (each, a Diligence Milestone ):
(i) within [***] years of the Effective Date, file an IND for a Licensed Product;
(ii) within [***] years of the Effective Date, initiate a Phase I Clinical Trial for a Licensed Product; and
(iii) within [***] years of the Effective Date, file a New Drug Application with the FDA in the U.S. for a Licensed Product.
Acorda shall provide written notice to the Institutions within thirty (30) days after it achieves a Diligence Milestone, such notice specifying the Diligence Milestone achieved.
(b) Acorda shall send to the Institutions within thirty (30) days of each calendar anniversary of the Effective Date an updated written development plan covering as a minimum the twelve (12) calendar months preceding the calendar anniversary and the twelve (12) calendar months following it. The report shall be in the form of Schedule 1 Part C and shall show:
(i) the projected and actual dates of first commericial sale;
(ii) milestone progression (dates for projected and achieved milestones); and
(iii) all past, current and projected activities taken or to be taken by Acorda and/or its Affiliates and their sublicensees to bring Licensed Products to market and maximize the sale of Licensed Products in the Licensed Territory.
The Institutions receipt or approval of any such plan shall not be taken to waive or qualify Acordas obligations under this Section 5.4
(c) If Acorda does not in a timely manner meet a Diligence Milestone set forth in Section 5.4(a), but Acorda provides to Institutions written evidence that it has used commercially reasonable efforts to meet such Diligence Milestone, then Institutions and Acorda shall negotiate in good faith for sixty (60) days after the applicable Diligence Milestone due date and agree upon a reasonable extension for such Diligence Milestone; provided that the period of such extension shall be between one (1) year and three (3) years. Additional extensions to the same Diligence Milestone (and correlatively, extensions to subsequent Diligence Milestones, as applicable) may be negotiated by the Parties in accordance with this Section 5.4(c), if necessary, based upon the progress that has been made by Acorda to meet the unmet Diligence Milestone.
(d) If Acorda does not in a timely manner meet a particular Diligence Milestone, and either (i) Acorda has not used commercially reasonable efforts to meet the applicable Diligence Milestone and Institutions provide the basis of such determination to Acorda in a written statement, or (ii) the Parties cannot, despite using good faith efforts, agree on a reasonable extension for the applicable Diligence Milestone in accordance with Section 5.4(c), then Institutions may, upon written notice to Acorda, terminate the exclusivity of the licenses granted to Acorda under this Agreement, which licenses shall thereafter be non-exclusive.
5.5 Non-Diligence . If Acorda ceases conducting, either itself or through its Affiliates or sublicensees, the development and/or commercialization of any and all Licensed Products, then Institutions may terminate this Agreement and the licenses granted to Acorda under this Agreement in accordance with the following provisions: the Institutions shall provide Acorda with written notice specifying in detail the basis for Institutions belief that it has the right to terminate under this Section 5.5, and Acorda shall have sixty (60) days in which to demonstrate, to Institutions reasonable satisfaction, that it (or its Affiliate or sublicensee), is conducting development and/or commercialization of at least one (1) Licensed Product. During such sixty (60) day period, the Parties shall discuss in good faith whether such demonstration shows Acordas continued development and/or commercialization of at least one (1) Licensed Product; provided, however, that periods of inactivity in development that is typical for similar products in similar stages of development shall not be deemed Acordas cessation of development. If the Parties fail to agree on whether Acorda has ceased conducting development and/or commercialization of at least one (1) Licensed Product during such period, then the Parties shall promptly agree upon and engage an independent, qualified individual (the Expert) to make such determination. The Expert shall (a) have at least eight (8) years of significant experience in the biotechnology industry relating to strategic development of pharmaceutical products, (b) not be directly or indirectly affiliated with either Party or with either Partys Affiliates or sublicensees, and (c) not have any direct or indirect interest of any kind in the resolution of whether Acorda is continuing development and/or commercialization of Licensed Products. If the Expert determines that Acorda has ceased conducting development and/or commercialization of any and all Licensed Products, then Institutions may thereafter terminate this Agreement upon written notice and, if applicable, the provisions of Section 10.5 shall apply. In such event, costs for engaging such Expert shall be borne by Acorda. If the Expert determines that Acorda is continuing development and/or commercialization of Licensed Products, then the Parties shall continue their respective activities under this Agreement and costs for engaging such Expert shall be borne by Institutions. For clarity, conduct of de minimus development work which is not reasonably supportable as part of a good faith development effort shall not, of itself, prevent a finding that Acorda (or its Affiliate or sublicensee) has ceased development of Licensed Products.
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
ARTICLE 6
PATENTS AND PATENT COSTS
6.1 Prosecution and Maintenance of Licensed Patents. The Institutions and Acorda shall work collaboratively to effect and conduct the ongoing patent prosecution and maintenance activities relating to the Licensed Patents. CUTS shall be primarily responsible for overseeing such ongoing patent prosecution and shall pursue such patent prosecution to further Acordas reasonable commercial interest in the Licensed Patents. CUTS shall provide Acorda with copies of all material documents relating to the filing, prosecution and maintenance of Licensed Patents, including filings and correspondence with patent authorities, in a timely manner, so as to give Acorda an opportunity to comment thereon. Acorda may provide comments to the Institutions regarding such patent prosecution (including but not limited to guidance in the drafting of claims for the Patent Application and other Licensed Patents) and the Institutions will pay due and reasonable consideration to such comments regarding claims relating directly to Licensed Enzyme Products. Acorda agrees to keep any documentation received under this Section 6.1 confidential in accordance with Article 9 herein.
6.2 Patent Costs.
(a) Enzyme Method Patent Costs. Acorda shall pay for all reasonable costs for prosecution and maintenance of patent filings of the Licensed Patents, to the extent of claims therein relating to enzymatic methods of treating CNS disorders, diseases or injuries ( Enzyme Method Patent Costs ), incurred by CUTS after the Effective Date of this Agreement.
(b) Small Molecule Inhibitor Method Patent Costs. Acorda shall pay a percentage, calculated in accordance with Section 6.2(b)(i), of all reasonable costs for prosecution and maintenance of patent filings of the Licensed Patents, to the extent of claims therein relating to small molecule inhibitors for use in treating CNS disorders, diseases or injuries ( Small Molecule Inhibitor Method Patent Costs ), incurred by CUTS after the Effective Date of this Agreement.
(i) Allocation and Reimbursement of Small Molecule Inhibitor Method Patent Costs. Acorda shall pay the percentage of Small Molecule Inhibitor Method Patents Costs calculated on the basis of the total number of non-exclusive licenses granted by
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
CUTS and/or KCL under the claims in the Licensed Patents relating to small molecule inhibitors for the treatment of CNS disorders, diseases or injuries in accordance with the following formula:
|
1 |
|
x 100 |
|
|
|
total number of non-exclusive licenses granted by CUTS and/or KCL |
|
|
By way of example, if Acorda holds one (1) of two (2) non-exclusive licenses under such claims, Acorda will pay fifty percent (50%) of all Small Molecule Inhibitor Method Patent Costs.
CUTS shall promptly notify Acorda in writing of any grant of a non-exclusive license under the claims in the Licensed Patents relating to small molecule inhibitors for the treatment of CNS disorders, diseases or injuries.
(c) Calculation of Patent Costs. The Parties acknowledge and agree that it may be difficult to determine patent costs relating to either the use of enzymes, or small molecule inhibitors, for the treatment of CNS disorders, diseases or injuries, given that both methods are included in a single patent application. If any Party disagrees with the allocation of patent costs calculated in accordance with Sections 6.2(a) and 6.2(b), then Institutions and Acorda shall use their good faith efforts to negotiate and determine a reasonable allocation of any patent costs such that Enzyme Method Patent Costs will reasonably reflect prosecution and maintenance costs relating to such enzyme method and the Small Molecule Inhibitor Patent Costs will reasonably reflect prosecution and maintenance costs relating to such small molecule inhibitor method. For the avoidance of doubt, as of the Effective Date, the Small Molecule Inhibitor Patent Costs and the Enzyme Method Patent Costs each constitute fifty percent (50%) of the total patent costs for the Licensed Patents since they are combined in one patent application, provided, however, that such percentage may change during the term of this Agreement if, for example, the Patent Application is separated into multiple patent applications.
6.3 Acordas Payment Terms. CUTS shall seek Acorda written approval prior to commitment of Enzyme Method Patent Costs and Small Molecule Inhibitor Method Patent Costs where practical and Acorda shall give or withhold approval within ten (10) calendar days. Where impractical to seek Acorda approval in the time available, CUTS shall have discretion to assume Acorda approval and commit but limit any such commitment of Enzyme Method Patent Costs and Small Molecule Inhibitor Method Patent Costs to five thousand dollars ($5,000).
6.4 Non-Payment Terms. In the event that payment is not received by CUTS within thirty (30) days of receipt by Acorda of an invoice for Enzyme Method Patent Costs and/or Small Molecule Inhibitor Method Patent Costs pursuant to Article 6 of this Agreement, the Institutions may charge interest on any outstanding amount on a daily basis at 3% above Barclays Bank plc base lending rate then in force. All payments due pursuant to Article 6 of this Agreement shall be made without deduction of income tax or other taxes charges or duties. Payments due between the end of the final Payment Period and termination or expiry of this Agreement shall be paid within thirty (30) days of said termination or expiry.
6.5 Acordas Payment Obligation. Acordas obligation, pursuant to Section 6.2, to pay for domestic and foreign patent filing, prosecution, and maintenance costs for Licensed Patents shall continue for so long as this Agreement remains in effect. However, Acorda may terminate such obligation with respect to any given patent and/or patent application in the Licensed Patents in any particular country and/or jurisdiction upon thirty (30) days written notice to Institutions. If Acorda terminates its payment obligation as to a particular patent or patent application, then:
(a) Acorda will be responsible for the payment of (i) all outstanding Enzyme Method Patent Costs and Small Molecule Inhibitor Method Patent Costs in the country and/or jurisdiction at the time written notice is given; and (ii) any Enzyme Method Patent Costs and Small Molecule Inhibitor Method Patent Costs in the country and/or jurisdiction necessarily and reasonably incurred during the thirty (30) days following the date such written notice is given; and
(b) all license rights of Acorda and/or its Affiliates and their sublicensees under such patent and/or patent application in such country and/or jurisdiction shall terminate and all rights under such patent and/or patent application in such country and/or jurisdiction shall revert exclusively to the Institutions without encumbrance, and Institutions shall retain the right to commercialise the Patent Application at their sole discretion.
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
ARTICLE 7
INFRINGEMENT
7.1 Enforcement of Licensed Patents Relating to Enzymes. If either Acorda and/or its Affiliates or the Institutions become aware of a product made, used or sold in the Licensed Territory, which it believes infringes a Valid Claim relating to any pharmaceutical product containing or directly activating an enzyme, including but not limited to chondroitinase, to treat CNS disorders, diseases or injuries (the Enzyme Method ), the Party obtaining such knowledge shall promptly advise the other Parties of all relevant facts and circumstances pertaining to the potential infringement. Acorda shall have the first right, but not the obligation, to enforce any patent rights within the Licensed Patents against such infringement, at its own expense. The Institutions shall agree to be joined with Acorda in any such legal action subject to being indemnified and secured in a reasonable manner as to any costs, damages, expenses or other liability and shall have the right to be separately represented by their own counsel at their own expense. Before starting legal action in accordance with this Section 7.1 or agreeing to any settlement, Acorda shall consult the Institutions and consider their views about the advisability of the action or settlement, its effect on the public interest and how the action should be conducted.
(a) Recovery. Any damages or costs recovered in connection with any action filed by Acorda under this Section 7.1 which exceed Acordas out-of-pocket costs and expenses of litigation, shall be deemed to be Net Sales of Licensed Enzyme Products in the fiscal quarter received by Acorda. Earned Royalties on such Net Sales shall be payable by Acorda to Institutions in accordance with the terms of this Agreement.
(b) Backup Enforcement Right of Institutions. If Acorda does not, within one hundred twenty (120) days after receiving notice from Institutions of a potential infringement, or providing Institutions with notice of such infringement, either (i) effect the
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
termination of such infringement, or (ii) institute an action to prevent continuation thereof and, thereafter prosecute such action diligently, or if Acorda notifies Institutions that it does not plan to terminate the infringement or institute such action, then Institutions shall have the right but not the obligation to do so at their own expense; provided however, that Institutions shall first consult with Acorda and give due consideration to Acordas reasons for not instituting actions to terminate or otherwise prevent continuation of such infringement. If Institutions decide to pursue such infringement, Acorda shall cooperate with Institutions in such effort, at Institutions expense, including being joined as a party to such action if necessary. Institutions shall be entitled to retain all damages or costs awarded to Institutions in such action.
7.2 Enforcement of Licensed Patents Relating to Small Molecule Inhibitors. If either Acorda and/or its Affiliates or Institutions become aware of a product made, used or sold in the Licensed Territory, which it believes infringes a Valid Claim relating to small molecule inhibitors for use in treating CNS disorders, diseases or injuries (the Small Molecule Inhibitor Method ), the Party obtaining such knowledge shall promptly advise the other Parties of all relevant facts and circumstances pertaining to the potential infringement. Institutions shall have the first right, but not the obligation, to enforce any patent rights within the Licensed Patents against such infringement, at its own expense. Acorda shall agree to be joined with the Institutions in any such legal action subject to being indemnified and secured in a reasonable manner as to any costs, damages, expenses or other liability and shall have the right to be separately represented by their own counsel at their own expense. Before starting legal action in accordance with this Section 7.2 or agreeing to any settlement, the Institutions shall consult Acorda and consider their views about the advisability of the action or settlement, its effect on the public interest and how the action should be conducted.
(a) Recovery. Any damages or costs recovered in connection with any action filed by Institutions under this Section 7.2 which exceed Institutions out-of-pocket costs and expenses of litigation, shall be divided equally among Institutions, Acorda and any Third Party(ies) holding a non-exclusive license under Institutions rights in Licensed Patents relating to small molecule inhibitors for use in treating CNS disorders, diseases or injuries during the term of such infringement.
(b) Backup Enforcement Right of Acorda. If Institutions do not, within one hundred eighty (180) days after receiving notice from Acorda of a potential infringement, or providing Acorda with notice of such infringement, either (i) effect the termination of such infringement, or (ii) institute an action to prevent continuation thereof and, thereafter prosecute such action diligently, or if Institutions notify Acorda that it does not plan to terminate the infringement or institute such action, then Acorda shall have the right but not the obligation to do so at its own expense; provided however, that Acorda shall first consult with Institutions and give due consideration to Institutions reasons for not instituting actions to terminate or otherwise prevent continuation of such infringement. If Acorda decides to pursue such infringement, Institutions shall cooperate with Acorda in such effort, at Acordas expense, including being joined as a party to such action if necessary. Acorda shall be entitled to retain all damages or costs awarded to Acorda in such action.
7.3 Enforcement of Licensed Patents Generally. If either Acorda or Institutions become aware of a product made, used or sold in the Licensed Territory, which it believes
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
infringes a Valid Claim that does not relate specifically to either the Enzyme Method or the Small Molecule Inhibitor Method, the Party obtaining such knowledge shall promptly advise the other Parties of all relevant facts and circumstances pertaining to the potential infringement. Acorda shall have the first right, but not the obligation, to enforce any patent rights within the Licensed Patents against such infringement, at its own expense. The Institutions shall agree to be joined with Acorda in any such legal action subject to being indemnified and secured in a reasonable manner as to any costs, damages, expenses or other liability and shall have the right to be separately represented by their own counsel at their own expense. Before starting legal action in accordance with this Section 7.3 or agreeing to any settlement, Acorda shall consult the Institutions and consider their views about the advisability of the action or settlement, its effect on the public interest and how the action should be conducted.
(a) Recovery. Any damages or costs recovered in connection with any action filed by Acorda under this Section 7.3 which exceed Acordas out-of-pocket costs and expenses of litigation, shall be deemed to be Net Sales of Licensed Small Molecule Inhibitor Products in the fiscal quarter received by Acorda. Earned Royalties on such Net Sales shall be payable by Acorda to Institutions in accordance with the terms of this Agreement.
(b) Backup Enforcement Right of Institutions. If Acorda does not, within one hundred eighty (180) days after receiving notice from Institutions of a potential infringement, or providing Institutions with notice of such infringement, either (i) effect the termination of such infringement, or (ii) institute an action to prevent continuation thereof and, thereafter, prosecute such action diligently, or if Acorda notifies Institutions that it does not plan to terminate the infringement or institute such action, then Institutions shall have the right but not the obligation to do so at their own expense; provided however, that Institutions shall first consult with Acorda and give due consideration to Acordas reasons for not instituting actions to terminate or otherwise prevent continuation of such infringement If Institutions decide to pursue such infringement, Acorda shall cooperate with Institutions in such effort, at Institutions expense. including being joined as a party to such action if necessary. Institutions shall be entitled to retain all damages or costs awarded to Institutions in such action.
7.4 Invalidity or Unenforceability Defenses or Actions.
(a) If a Third Party asserts, as a defense or as a counterclaim in any infringement action under Sections 7.1, 7.2 or 7.3, that any Licensed Patent is invalid or unenforceable, or that an interference should be declared with respect to a Licensed Patent, then the Parties shall promptly meet (which meeting may at any Partys request be by telephone conference or videoconference) to discuss the response to such defense or defense of such counterclaim or action (as applicable) and shall cooperate with one another in such response or defense. The Party or Parties that are the plaintiffs in the underlying suit or action against such Third Party shall have the initial right to respond to such defense or defend against such counterclaim (as applicable), provided that such response or defense shall be conducted in collaboration with the other Parties, to the extent that the other Parties intellectual property rights or rights under this Agreement are the subject of such invalidity or unenforceability defense or counterclaim. The Party plaintiff shall involve such other Party(ies) in all decisions as to such response or defense, and in any event such Party plaintiff shall not settle or otherwise compromise such defense or counterclaim in any way that adversely affects such other Partys
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
intellectual property rights or rights under this Agreement without such other Partys written consent, not to be unreasonably withheld or delayed.
(b) Similarly, if a Third Party asserts, in a declaratory judgment action or similar action or claim filed by such Third Party that any Licensed Patent is invalid or unenforceable or that an interference should be declared with respect to a Licensed Patent, then the Parties shall promptly meet (which meeting may at any Partys request be by telephone conference or videoconference) to discuss the defense of such action or claim and shall cooperate with one another in such defense. The Party that is the defendant in such claim, suit or action shall have the initial right to defend against same, provided that such defense shall be conducted in collaboration with the other Parties and a process under which each Party shall have a reasonable opportunity to participate in such defense shall be established, and in any event Acorda shall at all times be permitted to intervene in such defense, at its expense, and provided further that to the extent that any other Partys intellectual property rights or interests under this Agreement are the subject of, or materially impacted by, such invalidity or unenforceability claim, suit or action, the defending Party shall involve such other Party in all decisions as to such defense, and in any event such defending Party shall not settle or otherwise compromise such defense in any way that adversely affects such other Partys intellectual property rights or its rights under this Agreement without such other Partys written consent, not to be unreasonably withheld or delayed.
(c) The Party defending any claim or action under this Section 7.4 shall be responsible for one hundred percent (100%) of the out-of-pocket and reasonable costs and expenses of any such defenses, provided that if Acorda is defending, Acorda may credit such defense costs and expenses against royalties owed to Institutions under Sections 3.2 and 3.3.
7.5 Third Party Litigation. If a Third Party institutes an infringement suit or action against Acorda and/or its Affiliate and/or sublicensee alleging that the manufacture, use or sale of any Licensed Product by Acorda and/or an Affiliate and/or sublicensee, in a country in the Licensed Territory infringes one or more patent or other intellectual property right held by such Third Party (an Infringement Suit ), Acorda (or such Affiliate or sublicensee) shall have the right to defend and settle such Infringement Suit at its sole expense. In such event, the Parties shall meet (which meeting may at any Partys request be by telephone conference or videoconference) and discuss in good faith the best defenses to such Infringement Suit, and Institutions shall, subject to being indemnified against any liability and having the right to be separately represented by their own counsel at their own expense, provide Acorda with reasonable assistance and cooperation in defending such Infringement Suit at Acordas sole expense. Acorda shall have the right to credit against royalties owed to the Institutions under Sections 3.2 and 3.3 fifty percent (50%) of any costs and expenses of such defense and settlement, but solely to the extent such costs and expenses relate directly to the defense and settlement (if any) of any claims or allegations relating directly to infringement by the Licensed Product. If, however, such Third Party makes a payment to reimburse Acorda (and/or its Affiliate and/or sublicensee) for such costs and expenses of defending such infringement suit or action, then Acorda will pay to Institutions, out of such Third Party payment, a pro rata amount (i.e., the ratio of the amount of the Third Party payment compared to the total defense costs and expenses), but not to exceed the total amount that Acorda credited against royalties owed under the previous sentence. Notwithstanding the foregoing, Acorda (or such Affiliate or sublicensee)
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
shall not settle any such Infringement Suit in a manner that materially adversely impacts the Licensed Patents without Institutions prior written consent, such consent not to be unreasonably withheld or delayed. For clarity, any costs and expenses of enforcing Licensed Patents, including those costs relating to the assertion of a counterclaim alleging infringement of Licensed Patents by a Third Party in response to an Infringement Suit, shall not be included in the calculation and allocation of costs and expenses under this Section 7.5, but instead shall be included in the calculation and allocation of costs and expenses under Section 7.1, 7.2 or 7.3, as applicable.
ARTICLE 8
INDEMNIFICATION AND LIMITATION OF LIABILITY
8.1 Limitation of Liability. NO PARTY SHALL BE LIABLE TO ANOTHER PARTY, ITS AFFILIATES, CUSTOMERS OR SUBLICENSEES FOR ANY COMPENSATORY, SPECIAL, INCIDENTAL, INDIRECT, CONSEQUENTIAL OR EXEMPLARY DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT OR THE MANUFACTURE, TESTING, LABELING, USE OR SALE OF LICENSED PRODUCTS. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 8.1 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTIONS 8.2, 8.3 OR 8.4, OR DAMAGES AVAILABLE FOR BREACHES OF CONFIDENTIALITY OBLIGATIONS IN ARTICLE 9.
8.2 Indemnification by Acorda.
(a) Indemnification of CUTS. Acorda and/or its Affiliate shall defend, indemnify and hold harmless CUTS and the University of Cambridge, and their respective directors, students and employees (the CUTS Indemnitees ), from and against any and all losses, liabilities, expenses or damages (including reasonable attorneys fees) (collectively, the Losses ) resulting from claims made or legal proceedings instituted, made or brought against any CUTS Indemnitee by a Third Party arising or alleged to arise by reason of, or in connection with, any and all personal injury (including death) and property damage caused by the manufacture, testing, design, use, Sale or labeling of any Licensed Products by Acorda or its Affiliates, contractors, agents or sublicensees, except to the extent of any Losses that arise from the negligence or intentional misconduct of any CUTS Indemnitee.
(b) Indemnification of KCL. Acorda shall defend, indemnify and hold harmless KCL and its directors, students and employees (the KCL Indemnitees ), from and against any and all Losses resulting from claims or legal proceedings instituted, made or brought against any KCL Indemnitee by a Third Party arising or alleged to arise by reason of, or in connection with, any and all personal injury (including death) and property damage caused by the manufacture, testing, design, use, Sale or labeling of any Licensed Products by Acorda or its Affiliates, contractors, agents or sublicensees, except to the extent of any Losses that arise from the negligence or intentional misconduct of any KCL Indemnitee.
8.3 Indemnification by CUTS. CUTS shall defend, indemnify and hold harmless Acorda and its Affiliates, directors, officers, agents, contractors, sublicensees and employees (the
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
Acorda Indemnitees ) from and against any and all Losses resulting from claims or legal proceedings instituted, made or brought against any Acorda Indemnitee by a Third Party arising or alleged to arise by reason of, or in connection with, any breach of Section 12.2 by CUTS, except to the extent of any Losses that arise from the gross negligence or intentional misconduct of any Acorda Indemnitee, and in any such event, CUTS liability to the Acorda Indemnitees shall not exceed the total amount of the portion of all payments paid by Acorda to CUTS under this Agreement that CUTS retains and is not subsequently paid by CUTS to KCL; provided however, and CUTS hereby agrees, that such limitation shall not exclude or restrict CUTS liability for any fraud or other intentional misrepresentation, or death and personal injury caused by gross negligence or wilful misconduct of any CUTS Indemnitee.
8.4 Indemnification by KCL. KCL shall defend, indemnify and hold harmless Acorda Indemnitees from and against any and all Losses resulting from claims or legal proceedings instituted, made or brought against any Acorda Indemnitee by a Third Party arising or alleged to arise by reason of, or in connection with, any breach of Section 12.1 by KCL, except to the extent of any Losses that arise from the gross negligence or intentional misconduct of any Acorda Indemnitee, and in any such event, KCL liability to the Acorda Indemnitees shall not exceed the total amount of the portion of all payments paid by Acorda to KCL under this Agreement; provided however, and KCL hereby agrees, that such limitation shall not exclude or restrict KCL liability for any fraud or other intentional misrepresentation, or death and personal injury caused by gross negligence or wilful misconduct of any KCL Indemnitee.
8.5 General Conditions of Indemnification. To be eligible to be indemnified hereunder, the indemnified Party shall provide the indemnifying Party with prompt notice of the claim giving rise to the indemnification obligation pursuant to this Article 8 and the exclusive ability to defend (with the reasonable cooperation of the indemnified Party) or settle any such claim; provided, however, that the indemnifying Party shall not enter into any settlement for damages other than monetary damages without the indemnified Partys prior written consent, such consent not to be unreasonably withheld or delayed. The indemnified Party shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by the indemnifying Party.
8.6 Insurance. Each Party shall maintain reasonable levels of insurance or other adequate forms of protection to satisfy its respective indemnification obligations under this Agreement.
ARTICLE 9
CONFIDENTIALITY
9.1 Nondisclosure of Confidential Information. Except as otherwise provided hereunder, during the term of this Agreement and for a period of five (5) years thereafter, each Party (the Receiving Party ) agrees to retain in strict confidence, use only for the purposes of this Agreement, and not disclose any written information or data supplied by or on behalf of another Party to such Receiving Party under this Agreement and marked as proprietary or confidential ( Confidential Information ). Any written information, materials or data disclosed by one Party to another Party pursuant to the Confidential Disclosure Agreement
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
among the Parties dated July 3, 2002 shall be deemed the disclosing Partys Confidential Information under this Agreement and shall be subject to the provisions of this Article 9.
9.2 Permitted Disclosure. It shall not be a breach of this Article 9 if the Receiving Party is required to disclose another Partys Confidential Information pursuant to an order of the government or a court of competent jurisdiction, provided that the Receiving Party (a) provides such other Party with adequate notice of the required disclosure, (b) cooperates with such other Partys efforts to protect its Confidential Information with respect to such disclosure and (c) takes all reasonable measures requested by such other Party to challenge or to modify the scope of such required disclosure. To the extent that it is reasonably necessary to fulfill its obligations or exercise its rights under this Agreement, or any rights which survive termination or expiration hereof, the Receiving Party may disclose Confidential Information of such other Party to its Affiliates, sublicensees, consultants, outside contractors and clinical investigators provided that such entities or persons are bound by obligations of confidentiality and non-use no less restrictive than the obligations in this Agreement and agree to use the Confidential Information only for such purposes as the Receiving Party is authorized to use the Confidential Information hereunder.
9.3 Exceptions. The obligation of a Party under Section 9.1 not to use or disclose another Partys Confidential Information shall not apply to any part of such Confidential Information that the Receiving Party can establish by competent written proof:
(a) at the time of disclosure is in the public domain or after disclosure comes into the public domain other than by unauthorized acts of the Receiving Party obligated not to disclose such Confidential Information and/or its Affiliates and/or sublicensees in contravention of this Agreement;
(b) is disclosed to the Receiving Party, its Affiliates or sublicensees by a Third Party having the right to disclose it;
(c) can be shown by written proof to already have been in the possession of the Receiving Party, its Affiliates or sublicensees prior to disclosure under this Agreement; or
(d) results from the research and development by the Receiving Party, its Affiliates or sublicensees, independent of disclosures from the disclosing Party of this Agreement, provided that the persons developing such information have not had exposure to the Confidential Information received from the disclosing Party.
9.4 Confidential Nature of Terms of Agreement. Except as expressly provided herein, each Party agrees not to disclose any terms of this Agreement to any Third Party without the consent of the other Parties; provided, however, that disclosures may be made as required by securities or other applicable laws, or to actual or prospective investors, sublicensees, corporate or merger partners or acquirers, or to a Partys accountants, attorneys, and other professional advisors, and, in the case of the Institutions, to The Wellcome Trust and in the case of KCL to IP2IPO Limited, provided that such individuals or entities expressly agree to keep the terms of the Agreement confidential.
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
ARTICLE 10
TERM AND TERMINATION
10.1 Term. Unless sooner terminated as otherwise provided in this Agreement, the term of this Agreement shall commence on the Effective Date hereof and shall continue in full force and effect until the expiration of the last to expire Valid Claim and on such date this Agreement and the licenses granted hereunder shall automatically become non-exclusive, worldwide, fully paid-up, irrevocable licenses upon such expiry.
10.2 Termination by Acorda. Acorda may terminate this Agreement at any time upon ninety (90) days prior written notice to each of CUTS and KCL.
10.3 Termination by Institutions. The Institutions may terminate this Agreement forthwith by giving written notice to Acorda if Acorda and/or its Affiliates and/or agents and/or sub-contractors and/or sublicensees commence(s) legal proceedings to challenge the validity or ownership of any of the Licensed Patents.
10.4 Termination by any Party
(a) Material Breach. CUTS and KCL may terminate this Agreement if Acorda materially breaches its material obligations under this Agreement (e.g., material failure to pay CUTS and KCL pursuant to the terms of this Agreement) and Acorda fails to cure the breach within sixty (60) days after receipt of written notice from the non-breaching Party, such notice specifying in detail the nature of the alleged breach. Acorda may terminate this Agreement if one or both of the other Parties materially breaches its material obligations under this Agreement and such breaching Party(ies) fails to cure the breach within sixty (60) days after receipt of written notice from Acorda, such notice specifying in detail the nature of the alleged breach
(b) Cease of Business. Without prejudice to any other right or remedy, any Party may terminate this Agreement at any time by notice in writing to the other Parties, if any Party ceases to carry on business, is declared by a court of competent jurisdiction to be bankrupt, or an order made or a resolution passed for the winding up of any Party or upon the appointment of a liquidator of that Party.
10.5 Consequences of Termination. No termination of this Agreement shall relieve Acorda of the liability for payment of any Earned Royalties due for Licensed Products sold prior to the effective date of such termination or for Sublicense Royalties paid or payable prior to the effective date of such termination. Notwithstanding anything herein to the contrary, upon any termination or expiration of this Agreement, Acorda shall have the right to use or sell Licensed Products on hand on the date of such termination or expiration and to complete Licensed Products in the process of manufacture at the time of such termination or expiration and use or sell the same, provided that Acorda shall submit the applicable royalty reports described in Section 4.1, along with Earned Royalty and/or Sublicense Royalty payments in accordance with Sections 3.2, 3.3 and 3.4 for Sale of such Licensed Products. For clarity, upon termination of
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
this Agreement under Section 10.2 or 10.3, Institutions are free to enter into a commercial license or similar agreement with any Third Party with respect to such Licensed Patents, or otherwise exploit such Licensed Patents. Further, upon the Institutions written request, the Parties shall negotiate in good faith the terms of an agreement between them on reasonable commercial terms to enable the Institutions to arrange for further exploitation of the Licensed Products as they exist at the date of termination, including to provide the Institutions with all improvements, information and results created or developed by Acorda and/or its Affiliates and/or their agents.
ARTICLE 11
ASSIGNMENT
No Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other Parties, except Acorda may make such an assignment without Institutions written consent to an Affiliate or to a successor to all, or substantially all, of the business of Acorda, whether in a merger, sale of stock, sale of assets or other transaction, provided, however, that Acorda may not assign or transfer this Agreement or any rights or obligations hereunder without Institutions written consent to such a successor entity where a significant portion of such entitys commercial business activity constitutes: (a) the manufacture and/or sale of military arms or weapons, or (b) the manufacture and/or sale of tobacco containing products. Any permitted successor or assignee of rights and/or obligations hereunder shall, in a writing to the other Parties, expressly assume performance of such rights and/or obligations. Any assignment or attempted assignment by any Party in violation of the terms of this Article 11 shall be null and void and of no legal effect.
ARTICLE 12
MISCELLANEOUS
12.1 KCL confirms to Acorda that with respect to the Patent Application and/or the Licensed Patents:
(a) as far as KCL is aware, having neither commissioned nor performed any searches or investigations into the existence of any third party rights, KCL owns its interests in the Patent Application free and clear of all licenses and encumbrances and the like of any nature whatsoever;
(b) KCL is not currently involved in any litigation, and is unaware of any pending litigation proceedings, relating to Institutions ownership of the Patent Application;
(c) this Agreement is a legal and valid obligation of, binding upon, and enforceable against KCL in accordance with the terms of this Agreement;
(d) the execution, delivery and performance of this Agreement does not as of the Effective Date conflict with, constitute a breach of, or violate any arrangement, understanding or agreement to which KCL is a party or by which KCL is bound;
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
(e) KCL has not granted to a Third Party any right or interest in any of the Licensed Patents that is inconsistent with the rights granted to Acorda herein and shall not grant a Third Party any such right during the term of this Agreement;
(f) KCL has the right to enter into this Agreement, grant the rights granted herein and perform the obligations set forth in this Agreement; and
(g) KCL is the legal owner of its right, title and interest in the inventions developed by its respective Inventors giving rise to the Licensed Patents.
12.2 CUTS confirms to Acorda that with respect to the Patent Application and/or the Licensed Patents:
(a) as far as CUTS is aware, having performed no searches or investigations into the existence of any third party rights, CUTS owns its interests in the Patent Application free and clear of all licenses and encumbrances and the like of any nature whatsoever;
(b) CUTS is not currently involved in any litigation, and is unaware of any pending litigation proceedings, relating to Institutions ownership of the Patent Application;
(c) this Agreement is a legal and valid obligation of, binding upon, and enforceable against CUTS in accordance with the terms of this Agreement;
(d) the execution, delivery and performance of this Agreement does not as of the Effective Date conflict with, constitute a breach of, or violate any arrangement, understanding or agreement to which CUTS is a party or by which CUTS is bound;
(e) CUTS has not granted to a Third Party any right or interest in any of the Licensed Patents that is inconsistent with the rights granted to Acorda herein and shall not grant a Third Party any such right during the term of this Agreement;
(f) CUTS has the right to enter into this Agreement, grant the rights granted herein and perform the obligations set forth in this Agreement; and
(g) CUTS is the legal owner of its right, title and interest in inventions developed by Professor James Fawcett giving rise to the Licensed Patents.
12.3 Acorda confirms to Institutions that:
(a) this Agreement is a legal and valid obligation of, binding upon, and enforceable against Acorda in accordance with the terms of this Agreement;
(b) Acorda has the right to enter into this Agreement and perform the obligations set forth in this Agreement;
(c) the execution, delivery and performance of this Agreement does not conflict with, constitute a breach of, or violate any arrangement, understanding or agreement to which Acorda is a party or by which Acorda is bound; and
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
(d) Acorda shall be responsible for the performance by its Affiliates in accordance with the terms of this Agreement.
12.4 Disclaimer of Warranties. CUTS AND KCL MAKE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, AND ASSUMES NO RESPONSIBILITIES WHATSOEVER WITH RESPECT TO THE USE, SALE, OR OTHER DISPOSITION BY ACORDA AND/OR ITS AFFILIATES AND/OR ITS SUBLICENSEES OF LICENSED PRODUCT(S).
12.5 Independent Contractor. Acordas relationship to Institutions shall be that of a licensee only. None of the Parties shall be considered to be an employee or agent of another, nor shall this Agreement constitute, create or in any way be interpreted as a joint venture, partnership or formal business organization of any kind. In that respect, no Party shall have the authority to execute any agreement on behalf of another Party, nor shall any Party have any authority to negotiate any agreement, except as such other Party may expressly direct in writing.
12.6 Patent Marking. Acorda agrees to mark the appropriate patent number or numbers on all Licensed Products made or Sold in the Licensed Territory in accordance with all applicable governmental laws, rules and regulations, and to require its sublicensees to do the same.
12.7 Use of Names. Acorda shall obtain the prior written approval of KCL or CUTS (as applicable), such approval not to be unreasonably withheld, prior to making use of the name, trademarks, logos or symbols of KCL, the University of Cambridge, CUTS (an authorized designee of the University of Cambridge for purposes of this Agreement), or their respective employees, students and faculty members for any commercial purpose, except as required to comply with law, regulation or court order. Institutions shall obtain the prior written approval of Acorda, such approval not to be unreasonably withheld, prior to making use of the name, trademarks, logos or symbols of Acorda for any commercial purpose, except as required to comply with law, regulation or court order.
12.8 Governing Law. This Agreement and all amendments, modifications, alterations, or supplements hereto, and the rights of the Parties hereunder, shall be construed under and governed by the laws of England and shall be subject to the exclusive jurisdiction of the English courts to which the Parties hereby submit, except that a Party may seek interim injunction in any court of competent jurisdiction.
12.9 Entire Agreement. This Agreement, the Sponsored Research Agreement and the Material Transfer Agreements of even date constitutes the entire, final and exclusive agreement among the Parties hereto, and supercedes and terminates all prior agreements and understandings between the Parties, with respect to the subject matter hereof and thereof, whether written or oral, including the Confidential Disclosure Agreement among the Parties dated July 3, 2002. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.
12.10 Survival. Articles 1, 8, 9, and 12, and Sections 4.5, 4.6, 5.2 and 10.5 shall survive termination of this Agreement for any reason.
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
12.11 Severability. All rights and restrictions contained herein may be exercised and shall be applicable and binding only to the extent that they do not violate any applicable national laws and are intended to be limited to the extent necessary so that they will not render this Agreement illegal, invalid or unenforceable. If any provision or portion of any provision of this Agreement, not essential to the commercial purpose of this Agreement, shall be held to be illegal, invalid or unenforceable by a court of competent jurisdiction, it is the intention of the Parties that the remaining provisions or portions thereof shall constitute their agreement with respect to the subject matter hereof, and all such remaining provisions, or portions thereof, shall remain in full force and effect. To the extent legally permissible, the Parties shall use good faith efforts to agree to replace any illegal, invalid or unenforceable provision of this Agreement with a valid provision that shall implement as much as permitted the commercial intent of the illegal, invalid, or unenforceable provision. If any provision essential to the commercial purpose of this Agreement is held to be illegal, invalid or unenforceable and cannot be replaced by a valid provision which will implement the commercial intent of this Agreement, the Party(ies) who is the beneficiary of such illegal, invalid or unenforceable provision has the right to terminate this Agreement upon written notice, effective upon receipt, to the other Parties.
12.12 Notices. Any notice required or permitted to be given under this Agreement shall be in writing, shall specifically refer to this Agreement and shall be deemed to have been sufficiently given and received for all purposes (a) upon personal delivery to the appropriate address, (b) five (5) days after the date of mailing when sent first class certified or registered mail, postage prepaid, (c) three (3) business days after sending by internationally recognized express delivery service, or (d) one (1) business day after facsimile transmission to the appropriate number(s) below, with transmission confirmed by the recipient. Unless otherwise specified in writing in accordance with this Section 12.12, the mailing addresses and facsimile numbers of the Parties shall be as set forth below.
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For Acorda: |
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Acorda Therapeutics, Inc. |
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15 Skyline Drive |
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Hawthorne, New York 10532 USA |
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Attention: |
Harold Safferstein, Vice President, |
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Business Development |
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Fax Number: |
(914) 347-4560 |
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For CUTS: |
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Cambridge University Technical Services Limited |
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c/o Research Services Division |
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University of Cambridge |
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16 Mill Lane |
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Cambridge CB2 1SB, UK |
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Attention: Director |
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Fax Number: +44 (0)12 2333 2988 |
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For KCL: |
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Kings College London |
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KCL Enterprises Ltd |
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James Clerk Maxwell Building |
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57 Waterloo Road |
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London, SEI 8WA, UK |
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
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Attention: Director of Technology Transfer |
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Fax Number: +44 (0)20 7848 3320 |
12.13 Force Majeure. Any delays in, or failure of performance of any Party to this Agreement, shall not constitute a default hereunder, or give rise to any claim for damages, if and to the extent caused by occurrences beyond the control of the Party affected; including, but not limited to, acts of God, acts of terrorism, strikes or other concerted acts of workmen, civil disturbances, fires, floods, earthquakes, explosions, riots, war, rebellion, sabotage, acts of governmental authority or failure of governmental authority to issue licenses or approvals which may be required. The Party suffering such occurrence shall immediately notify the other Parties as soon as practicable and any time for performance hereunder shall be extended by the actual time of delay caused by the occurrence, provided that the Party affected by such occurrence uses reasonable efforts to overcome or avoid such delay.
12.14 Farther Assurances. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.
12.15 Headings. The headings appearing in this Agreement have been inserted for convenience of reference only and shall not affect the construction, meaning or interpretation of this Agreement or any of its terms and conditions.
12.16 No Waiver. The failure by any Party, at any time, or for any period of time, to enforce any of the provisions of this Agreement, shall not be construed as a waiver of such provisions or as a waiver of any Partys rights thereafter to enforce each and every such provision of this Agreement.
12.17 Construction. This Agreement has been prepared jointly by all Parties and shall not be strictly construed against any Party.
12.18 Counterparts. This Agreement may be executed in one (1) or more counterparts, each of which shall be deemed an original, but all of which shall constitute one (1) and the same instrument.
[ Signature Page Follows ]
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Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, which are marked with brackets [ ] and an asterisk*, have been separately filed with the Commission.
IN WITNESS WHEREOF , Acorda, CUTS and KCL have caused this Agreement to be executed as of the Effective Date by their duly authorized representatives below.
ACORDA THERAPEUTICS, INC. |
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CAMBRIDGE UNIVERSITY TECHNICAL |
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SERVICES LIMITED |
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By: |
/s/ Hank Safferstein |
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By: |
/s/ R. C. Jennings |
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Print Name: |
Hank Safferstein |
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Print Name: |
DR. R. C. Jennings |
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Title: |
V.P. Business Dev. |
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Title: |
DIRECTOR |
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KINGS COLLEGE LONDON
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/s/ SUSAN SMITH |
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Print Name: |
SUSAN SMITH |
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Title: |
DIRECTOR OF TECHNOLOGY TRANSFER |
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