Exhibit 10.2
Portions of this exhibit (indicated by “[**]”) have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.
EXECUTION COPY
Date: 26, September 2003
ELAN CORPORATION, PLC.
AND
ACORDA THERAPEUTICS, INC.
SUPPLY AGREEMENT
Fampridine SR
INDEX
CLAUSE 1 |
| PRELIMINARY |
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CLAUSE 2 |
| EXCLUSIVE SUPPLY |
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CLAUSE 3 |
| REGULATORY MATTERS |
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CLAUSE 4 |
| FORECASTS AND ORDERS |
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CLAUSE 5 |
| SUPPLY OF THE PRODUCT |
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CLAUSE 6 |
| DISPUTES AS TO SPECIFICATION |
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CLAUSE 7 |
| SECOND SOURCE |
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CLAUSE 8 |
| ADVERSE EVENTS AND PRODUCT RECALL |
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CLAUSE 9 |
| FINANCIAL PROVISIONS |
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CLAUSE 10 |
| PAYMENTS, REPORTS AND AUDITS |
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CLAUSE 11 |
| DURATION AND TERMINATION |
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CLAUSE 12 |
| CONSEQUENCES OF TERMINATION |
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CLAUSE 13 |
| REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION |
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CLAUSE 14 |
| MISCELLANEOUS PROVISIONS |
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SCHEDULE 1 |
| MANUFACTURING COST |
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
“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).
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“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.
“Elan’s 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 party’s inability to obtain supplies of components of the Product howsoever arising.
“FTE” means Elan’s 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
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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 Elan’s own costs for such manufacture, as calculated based on GAAP.
“Maximum Capacity” shall mean Elan’s 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 Acorda’s 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 Elan’s 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 Elan’s 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 Elan’s 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 company’s removal or correction of a marketed Product that the FDA or equivalent Governmental Authority considers to be in violation of law and against
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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 Acorda’s 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.
In addition, the following definitions have the meanings in the Clauses corresponding thereto, as set forth below:
Definition |
| Clause |
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“Discount” |
| 9.4 |
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“First Approval” |
| 4.1.1 |
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“Manufacturer” |
| 7.1 |
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“Resumption Quarter” |
| 7.6.1 |
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“Second Source” |
| 7.1 |
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“Second Source Quantity” |
| 7.2.1 |
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“Supply Price” |
| 9.3.1 |
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“Technical Agreement” |
| 5.5 |
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Except as otherwise defined in this Agreement, all capitalised terms used in this Agreement shall have the same meaning as in the Licence Agreement.
In this Agreement:
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CLAUSE 2 EXCLUSIVE SUPPLY
except as requested by Acorda, PROVIDED THAT to extent required by applicable law, Elan shall be permitted to:
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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 Elan’s 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
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facilities used in the development, manufacturing, packaging, storage or handling of the Product;
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 party’s activities under this Agreement will be provided to the other party within forty-eight (48) hours.
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.
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samples, as referred to herein, do not include samples retained for purposes of stability testing.
CLAUSE 4 FORECASTS AND ORDERS
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 Acorda’s 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 Acorda’s forecasts, Elan shall notify Acorda within five (5) days if Elan becomes aware that it will be unable to supply Acorda’s forecasted requirements of Product and, in such event, the provisions of Clause 4.6 shall be applicable.
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(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.
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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
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CLAUSE 6 DISPUTES AS TO SPECIFICATION
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destruction by Elan, at Acorda’s expense. In such an event Acorda will not be entitled to any credit as to the non-conforming Product.
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
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 Elan’s 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 Acorda’s 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:
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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 Acorda’s and/or Manufacturer’s scientific staff, as applicable, in its premises for certain periods, the term of which will be agreed by the parties; and
Acorda shall comply with its obligations and responsibilities relating to technology transfer to Patheon, as set forth in the Technology Transfer Responsibilities Schedule.
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:
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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.
Assuming compliance by Elan with Clause 7.1, Acorda shall be solely responsible for:
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Absent Elan’s 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.
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
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.
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it shall promptly give to the other party written notice of the same with full details.
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
Elan shall invoice Acorda for Launch Stocks at a price equivalent to Manufacturing Cost plus [**], subject to reconciliation pursuant to Clause 9.3.3.
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 Elan’s 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.
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subject to Clause 2.5. The foregoing price shall apply to Product supplied EXW Elan’s Facility packaged and labelled in final market form and consistent with the NDA.
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 Elan’s Manufacturing Cost for such excess tablets.
The Discount is without prejudice to Clause 2.3.
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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.
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:
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
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CLAUSE 12 CONSEQUENCES OF TERMINATION
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CLAUSE 13 REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION
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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.
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.
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TO MERCHANTABILITY, FITNESS FOR PURPOSE, CORRESPONDENCE WITH DESCRIPTION, OR NON-INFRINGEMENT.
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
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.
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This Agreement shall be binding upon and enure for the benefit of parties hereto, their successors and permitted assigns.
If any provision in this Agreement is deemed to be, or becomes invalid, illegal, void or unenforceable under applicable laws:
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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.
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.
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Elan at
c/o Elan Pharma Ltd.
Monksland
Athlone
Co. Westmeath
Ireland
Attention: | General Manager |
Fax: | +353 906 492427 |
Acorda at
15 Skyline Drive
Hawthorne, New York 10532
United States of America
Attention: | President |
Fax: | 914.347.4560 |
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or to such other address(es) and fax numbers as may from time to time be notified by either party to the other hereunder.
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.
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.
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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