Exhibit 10.55
CONFIDENTIAL AGREEMENT
EXECUTION VERSION
Certain identified information has been excluded from this exhibit because such information both (i) is not material and (ii) would likely cause competitive harm if publicly disclosed. Excluded information is indicated with brackets and asterisks [*****].Manufacturing Services Agreement
between
Catalent Massachusetts LLC
and
Acorda Therapeutics, Inc.
Effective Date: January 1, 2023
CONFIDENTIAL AGREEMENT
EXECUTION VERSION
MANUFACTURING SERVICES AGREEMENT
This MANUFACTURING SERVICES AGREEMENT (this “Agreement”) is made as of December 31 2022 (“Execution Date”) and effective as of January 1, 2023 ("Effective Date").
B E T W E E N:
CATALENT MASSACHUSETTS LLC, a Delaware corporation, having a place of business at 14 Schoolhouse Road, Somerset, New Jersey 08873, USA (“Manufacturer”),
- and -
ACORDA THERAPEUTICS, INC., a Delaware corporation (“Acorda”).
Whereas, the Parties terminated that certain Manufacturing Services Agreement, dated as of February 10, 2021, by and between Manufacturer and Acorda pursuant to that certain termination letter between the Parties effective as of December 31, 2022; and
Whereas, the Parties are entering into this Agreement to govern the manufacture of Batches (as defined below) to be provided by Manufacturer to Acorda following the Effective Date and other related matters;
Now, Therefore, in consideration of the rights conferred and the obligations assumed herein and for other good and valuable consideration (the receipt and sufficiency of which are acknowledged by each Party), the Parties, intending to be legally bound, agree as follows:
INTERPRETATION
“Acorda” has the meaning set forth in the introductory paragraph hereto and, in addition, includes any Acorda Affiliate added as an Additional Acorda Party pursuant to Section 13.5(e);
“Acorda Indemnitees” has the meaning specified in Section 10.2;
“Acorda Intellectual Property” means to the extent necessary to conduct the activities of Manufacturer hereunder, Intellectual Property to the extent owned or controlled by Acorda or its wholly-owned subsidiary Civitas Therapeutics, Inc. as of the Effective Date, including without limitation [*****];
“Acorda New Intellectual Property” means any New Intellectual Property other than the Manufacturer New Intellectual Property;
“Acorda Property” has the meaning specified in Section 8.4(a)(ii);
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“Acorda-Supplied Components/Materials” means the Components/Materials identified in Schedule 6 of this Agreement as Acorda-Supplied Components/Materials, as Schedule 6 may from time to time be amended in accordance with ARTICLE 4;
“Active Materials” means the materials listed and identified in Schedule 3;
“Active Materials Credit Value” means the value of the Active Materials for certain purposes of this Agreement, as set forth for the Product in Schedule 3;
“Actual Annual Yield” or “AAY” has the meaning specified in Section 2.7(a)(ii);
“Additional Acorda Party” has the meaning specified in Section 13.5(e);
“Affiliate” means, with respect to any Person, any other Person controlling, controlled by or under common control with such first Person. For purposes of this definition, “control” means, with respect to any entity, the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such entity, whether through the ownership of voting securities (or other ownership interest), by contract or otherwise;
“Agents” means (a) those employees of Manufacturer or any of its Affiliates at any particular time during the Term who require access to Lock Down Information for a Purpose; and (b) individual independent contractors engaged by Manufacturer at any particular time during the Term who require access to Lock Down Information for the purpose of providing Manufacturing Services;
“Agreement” has the meaning set forth in the introductory paragraph hereto;
“[*****]” means any Know-How or other Intellectual Property licensed to or acquired by [*****], directly or indirectly, under [*****];
“Ancillary Agreement” has the meaning set forth in the Asset Purchase Agreement;
“Annual Product Review Report” means the annual product review report prepared by Manufacturer regarding the Supplied Product as described in Title 21 of the United States Code of Federal Regulations, Section 211.180(e), and any other similar reports that may be required by Applicable Laws;
“Annual Report” means the annual report to the FDA prepared by Acorda regarding Marketed Product as described in Title 21 of the United States Code of Federal Regulations, Section 314.81(b)(2), and any other similar reports that may be required by Applicable Laws;
“Annual Volume Projection” means the annual volume projections set forth in the applicable portion of Schedule 2, as from time to time updated thereafter by written agreement of the Parties;
“Applicable Laws” means, with respect to Acorda, all laws, ordinances, rules and regulations, currently in effect or enacted or promulgated during the Term, and as amended from time to time, of each jurisdiction in which Active Material or Supplied Product or Marketed Product is produced, marketed, distributed, used or sold; and with respect to Manufacturer, all laws, ordinances, rules and regulations, currently in effect or enacted or promulgated during the Term, and as amended from time to time, of the jurisdiction in which Manufacturer Manufactures Supplied Product, including cGMP; and in the event that Supplied Product is being supplied for sale or use outside the United States, such other standards as may be agreed in the Quality Agreement or otherwise in writing between the Parties;
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“Asset Purchase Agreement” means that certain Asset Purchase Agreement to transfer certain of Acorda’s assets to Manufacturer, dated December 30th, 2020, between Acorda and Manufacturer;
“Authority” means any governmental or regulatory authority, department, body or agency or any court, tribunal, bureau, commission or other similar body, whether federal, state, provincial, county or municipal;
“Batch” means a specific quantity of Supplied Product that is intended to be of uniform character and quality, within specified limits, and is produced during the same cycle of manufacture as defined by the applicable Batch record; the approximate Batch sizes for PSD-4 are 340,000 capsules and the projected batch sizes for PSD-7, 1,600,000 capsules for filing; or for bulk powder 100kg, and 86,000 capsules for packaging/blistering;
“Bulk Product” means spray-dried intermediate in bulk powder of levodopa;
“Business Day” means a day other than a Saturday, Sunday or a day that is a statutory holiday in the Commonwealth of Massachusetts;
“cGMPs” means the then-current good manufacturing practices that apply to the manufacture of Supplied Product for incorporation into Marketed Product to be marketed, distributed, or sold in countries or jurisdictions in the Territory, including as described in:
together with the latest FDA, European Commission and EMA, Health Canada, and MHLW/PMDA (Japan), respectively, guidance documents issued by the relevant Authority pertaining to manufacturing and quality control practice in the applicable jurisdiction. “cGMPs” will also include the laws, regulations and guidance for any other jurisdiction in the Territory;
“COA” means a Certificate of Analysis for the applicable Batch;
“COA Target Date” means the date for the delivery of the COA specified in the Purchase Order, which shall not be less than 89 days from the delivery of the Purchase Order;
“COC” means a batch Certificate of Conformity which is issued by Manufacturer after Acorda’s documentation review and batch acceptance;
“Compliant Product Requirements” means, in respect of Supplied Product delivered hereunder, that the Manufacturing Services have been performed by Manufacturer in respect of such Supplied Product in compliance with all Specifications, cGMPs or other Applicable Laws, and other requirements set forth
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in this Agreement or the Quality Agreement and that the Supplied Product as delivered complies with the warranties set forth in this Agreement;
“Components/Materials” means all Active Materials, packaging components, raw materials, ingredients, disposable items, and other materials required to manufacture, package and label Supplied Product in accordance with the Specifications for delivery to Acorda in accordance with the terms of this Agreement;
“Confidential Information” means (a) any and all Know-How that has been, prior to the Effective Date, or is, at any time on or after the Effective Date, provided or communicated to the Receiving Party by or on behalf of the Disclosing Party (including by a third party) pursuant to this Agreement or other arrangements contemplated hereby or thereby or any discussions or negotiations with respect or leading up thereto, whether provided or communicated orally, visually, electronically, in writing, by delivery of materials containing such Know-How or material or in any other form now known or hereafter invented, and (b) without limiting the foregoing, Lock Down Information, Acorda Intellectual Property and any Acorda New Intellectual Property, as to which Acorda shall in all cases be deemed the Disclosing Party. Confidential Information includes all confidential and proprietary technologies, know-how, trade secrets, discoveries, inventions, and any other confidential and proprietary intellectual property (whether or not patented), analyses, compilations, business or technical information and other proprietary materials prepared by either Party, their Affiliates, or any of its or their respective Representatives, containing or based in whole or in part on any information furnished by or on behalf of the Disclosing Party, its Affiliates or any of its or their respective Representatives;
“Deficiency Notice” has the meaning specified in Section 6.2(a);
“Delivery Date” means the date of the Certificate of Analysis issued by Manufacturer to Acorda;
“Disclosing Party” has the meaning specified in Section 11.1;
“Dispute” has the meaning set forth in Section 12.1;
“Effective Date” has the meaning set forth in the introductory paragraph hereto;
“EMA” means the European Medicines Agency and any successor Authority having the same or similar jurisdiction;
“European Union” means those countries that are (a) the United Kingdom and (b) members of the European Union as of the Effective Date together with, from the date they become members of the European Union, any countries that become new members of the European Union during the Term. For clarity, the defined term “European Union” will continue to include any countries that may leave the European Union after the Effective Date despite their ceasing to be members of the European Union;
“Excluded Lists” means the Department of Health and Human Service’s List of Excluded Individuals/Entities and the General Services Administration’s Lists of Parties Excluded from Federal Procurement and Non-Procurement Programs;
“Existing Quality Agreement” means that certain Quality Agreement, dated as of May 6, 2021, by and between Manufacturer and Acorda, the current version of which is attached hereto as Exhibit C;
“FDA” means the United States Food and Drug Administration and any successor Authority having the same or similar jurisdiction;
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“Fees” means any fees due to Manufacturer hereunder;
“FFDCA” has the meaning specified in Section 9.3(c)(v);
“Force Majeure Event” has the meaning specified in Section 13.6;
“Grace Period” means the [*****] period after the COA Target Date;
“Health Canada” means the section of the Canadian government known as Health Canada and includes, among other departments, the Therapeutic Product Directorate and the Health Product and Food Branch Inspectorate and any successor Authorities having the same or similar jurisdictions;
“Indemnified Party” has the meaning specified in Section 10.4;
“Indemnifying Party” has the meaning specified in Section 10.4;
“Intellectual Property” means any and all intellectual property rights of whatever kind or nature, including rights in patents, patent applications, copyrights and Know-How, including trade secrets; “Know-How” means any confidential or proprietary information, data, formulae, computer program, device, know-how, process, design, technique, knowledge, records (including Batch records), analytical methods, standard operating procedures for products, specifications and parameters for manufacturing equipment, quality control and other methods, practices or the like, whether or not written or otherwise fixed in any form or medium, regardless of the media on which it is contained and whether or not patentable or copyrightable and whether or not they constitute trade secrets, including software, databases, algorithms, discoveries, improvements, specifications, diagrams, drawings expertise, technology, research, reports, documentation, equipment, methods of formulation, results of tests and field trials, specifications, and composites of materials;
“Knowledge” means, with respect to the applicable Party, the actual knowledge of the executive officers and directors of such Party, without a duty of inquiry or investigation;
“Late Delivery” means a failure to deliver to Acorda the COA by the end of the Grace Period;
“Lock Down Information” means the [*****] information [*****] outlined in Schedule 9;
“Losses” has the meaning specified in Section 10.2;
“Manufacturer” has the meaning set forth in the introductory paragraph hereto;
“Manufacturer Indemnitees” has the meaning specified in Section 10.3;
“Manufacturer Intellectual Property” means Intellectual Property owned or controlled (other than pursuant to the license set forth in Section 13.1(a)), or generated, discovered or developed, by or on behalf of Manufacturer or its Affiliates independently of the Manufacturing Services or other arrangements contemplated by this Agreement and without use of or reference to any Acorda Intellectual Property, [*****], or Acorda’s Confidential Information, in each case as demonstrated by competent contemporaneous written evidence, but in any event excluding any New Intellectual Property;
“Manufacturer New Intellectual Property” means any New Intellectual Property that is not exclusive to the Supplied Product or the Marketed Product or the Manufacture of Supplied Product or Marketed Product but (a) relates to developing, formulating, manufacturing, filling, processing, packaging,
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analyzing, or testing pharmaceutical products generally, or (b) is generated, discovered, or developed solely by or on behalf of Manufacturer or its Affiliates;
“Manufacturing Services” (including, with correlative meanings, “Manufacturing” and “Manufacture”) means those services required to manufacture, including to fill the dry powder capsules, label, release (including final release to Acorda) and deliver Supplied Product, and for orders by Acorda for blister pack versions, primary packaging in blister packs, using Components/Materials as provided herein, including, to the extent required:
For the avoidance of doubt, all ancillary services listed above (other than clause (e), which shall include the ongoing stability program at the Manufacturing Site) shall be provided only for Supplied Product that is Processed by Manufacturer during the Term;
“Manufacturing Site” means the facilities located at Brickyard Square, 190 Everett Avenue, and 115 Carter Street, Chelsea, MA and leased to Manufacturer;
“Marketed Product” means (a) Acorda’s CVT-301 inhaled levodopa product (the subject of a New Drug Application in the United States under the name Inbrija®), (b) [*****] and the same active pharmaceutical ingredient as the Supplied Product that Acorda may, by written notice to Manufacturer, indicate is also to be included within the definition of “Marketed Product”, and (c) any other product included in the definition of “Marketed Product” pursuant to Section 2.1(h);
“Marketing Authorization” means a New Drug Application as defined in the FFDCA and the regulations promulgated thereunder or, in respect of a country other than the United States, any corresponding application, registration or certification necessary for the marketing and sale of a pharmaceutical product in such country, including applicable pricing and reimbursement approvals;
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“Minimum Commitment” means, with respect to the applicable Year, the number of Batches required to be ordered by Acorda for delivery in such Year as set forth in Schedule 2.
At the request of Acorda, Minimum Commitments shall be reduced by [*****].
“New Intellectual Property” means Intellectual Property generated, discovered, or developed by or on behalf of either Party or its Affiliates (including, for clarity, jointly by Acorda or any of its Affiliates and Manufacturer or any of its Affiliates) while performing, or as a result of the performance of, the Manufacturing Services or in connection with the other arrangements contemplated by this Agreement;
“Net Sales” means, for the measured period, the gross invoiced amounts for Marketed Product sold or commercially disposed of for value by Acorda, its Affiliate or sublicensee to first third party, less [*****]. Sales of Marketed Product between Acorda and its sublicensees (including its Affiliates) shall be disregarded for the purposes of calculating Net Sales, and in such case Net Sales shall include only subsequent sales by the relevant sublicensee to a third party. Subject to the foregoing sentence, if any Marketed Products are sold or disposed of by Acorda, its Affiliate or its sublicensees other than in a bona fide arm’s length sale exclusively for money, then Net Sales for such Marketed Products shall be deemed to be the price at which Acorda, its Affiliate or sublicensee could have sold such Marketed Products in a separate arm’s length transaction to a willing purchaser at the relevant time in the relevant country. The amount of [*****] shall be included in Net Sales in the Quarter in which such reduction or reversal occurs. All calculations shall be made in accordance with GAAP. In the event that Acorda has a sublicensee in a country, then the Net Sales definition will be based on the gross invoice price sold by the sublicensee to a third party per the definition of Net Sales, including [*****]. Further, transfers or dispositions of a Marketed Product for [*****] will not be deemed to be Net Sales, provided that such transfers or dispositions shall be in amounts consistent with [*****];
“Other Components/Materials” means Components/Materials that are not Acorda-Supplied Components/Materials;
“Party” means, individually, Manufacturer or Acorda, and “Parties” means, collectively, Manufacturer and Acorda;
“Person” means an individual or a sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, or other similar entity or organization, including a government or department, agency or other subdivision thereof;
“Pharmaceutical Regulatory Authority” means the FDA, EMA, Health Canada, and MHLW/PMDA of Japan and any other Authority competent to regulate the manufacture, marketing, distribution or sale of pharmaceutical products, including Supplied Product and any Marketed Product, in the Territory;
“Product Fees” means the amount due to Manufacturer for a given quantity of Supplied Product delivered, as set forth in Section 3.1;
“Product Personnel” means [*****];
“PSD-4” means the spray dryer currently used to Manufacture Inbrija;
“PSD-7” means the new spray dryer intended to Manufacture Inbrija;
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“PSD-7 Scale-Up” means the scale-up with regard to the process for operationalization and validation of the PSD-7;
“PSD-7 Scale-Up Plan” means the plan with respect to PSD-7 Scale-Up;
“Purchase Order” has the meaning specified in Section 5.1(c);
“Purpose” means, in the case of employees, Product Personnel, or Agents who are individual independent contractors, the Manufacturing Services of Supplied Product hereunder; and in the case of Agents who are employees of Manufacturer or any of its Affiliates, any of the following in accordance with Manufacturer’s internal policies or as required by Applicable Law and related to the Supplied Product: (a) conducting audits; (b) addressing deviation escalations; (c) escalating quality and/or regulatory issues related to an investigation, change control or corrective and preventative actions; (d) third party vendors supporting electronic quality management systems (e.g., EDMS) who require access to the system for system troubleshooting and maintenance; (e) receiving information as part of required reporting needs related to (a), (b) and (c) or the Annual Product Maintenance Services and/or preparation of the Annual Product Review Report; (f) for the activities involving the technology transfer of the manufacturing activity in connection with the PSD-7 Scale-Up Plan or (g) other bona fide business purposes, which the Parties may agree to in writing signed by both Parties. Third party vendors specified in clause (d) are not intended to, and should not be permitted to, access data during system trouble shooting or maintenance, and therefore will not require lockdown training or tracking;
“Quality Agreement” means the agreement between the Parties setting out the quality assurance standards for the Manufacturing Services to be performed under this Agreement (either the Existing Quality Agreement or a new quality agreement entered into after the Execution Date, as applicable);
“Quality System” means a formalized system that documents processes, procedures and responsibilities necessary to design and deliver a product or perform a service in compliance with applicable laws, regulations and guidance documents;
“Quantity Converted” has the meaning specified in Section 2.7(a)(ii);
“Quantity Dispensed” has the meaning specified in Section 2.7(a)(ii);
“Quantity Received” has the meaning specified in Section 2.7(a)(ii);
“Quarter” means each consecutive period of three consecutive calendar months commencing on January 1, April 1, July 1, or October 1 and ending on, respectively, March 31, June 30, September 30, and December 31, except that the first Quarter of the Term will be the period from the Effective Date up to and including the end of such three-month period in which the Effective Date falls, and the last Quarter of the Term shall commence on the first day of such three-month period in which the Term ends and end on the last day of the Term;
“Recall” has the meaning specified in Section 6.3(a);
“Recalled Product” has the meaning set forth in Section 6.4(b);
“Receiving Party” has the meaning set forth in Section 11.1;
“Recipients” has the meaning set forth in Section 11.1;
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“Replacement Batch” means a Batch to be delivered to Acorda as a replacement for a Batch that has not been delivered to Acorda pursuant to a Purchase Order, rejection of a Batch pursuant to Sections 2.1(f) and 6.1 herein, or as a result of a failure to achieve Timely Delivery as set forth in Section 5.1 herein;
“Representatives” of an entity means such entity’s officers, directors, employees, agents, members, accountants, attorneys, or other professional advisors;
“Reserved Capacity” means with respect to (a) the PSD-4, [*****] (b) [*****], then Manufacturer shall reserve the following until the PSD-7 is first approved for at least one of the Tier 1 Markets, [*****], and (c) in the event that the PSD-7 is approved but becomes unavailable, [*****];
[*****];
“Serious Performance Failure” means for a given Year, [*****];
“Shelf Life Start Date” means for any Batch, the date on which Active Material is added into the solution;
“Shortfall” has the meaning specified in Section 2.7(a)(iii);
“Specifications” means (a) for the initial Supplied Product, the file designated as “Specifications” that has been delivered by Acorda or its Affiliate to Manufacturer on or before the Effective Date containing information as specified on Schedule 1 or (b) for any future Supplied Product, the file designated as “Specifications” for such Supplied Products, in each case all as updated, amended and revised from time to time in accordance with the terms of this Agreement and the change control process set forth in the Quality Agreement;
“Supplied Product” means (a) bulk dry powder, produced by spray drying at the Manufacturing Site using Acorda Intellectual Property, including [*****], and filled into capsules and (b) if requested in the order from Acorda, the bulk dry powder described in clause (a) packed in blister packs ready for secondary packaging as Marketed Product for marketing, distribution, and sale of such Marketed Product in the Territory, (c) subject to Section 2.5(a), bulk dry power described in clause (a) not otherwise filled into capsules or blister packs, but in a packaging agreed upon by the Parties (provided that such packaging is that used to generate the relevant stability data), or (d) in the case of a new Marketed Product added to this Agreement, such product in the form supplied hereunder as mutually agreed, each case ((a) through ((c)) as further identified and described in the applicable Specifications, including any release criteria for the applicable Supplied Product;
“Target Yield” has the meaning specified in Section 2.7(a);
“Term” has the meaning specified in Section 8.1(a);
“Territory” means worldwide, but Manufacturer shall not be obligated to ship Supplied Product into any country where that would constitute a violation of comprehensive sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom, or the United States;
“Third Party Claims” has the meaning specified in Section 10.2;
“Third Party Rights” means the Intellectual Property of any third party;
“Tier 1 Market” means the United States of America and Germany;
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“Tier 2 Market” means any country in the world other than the Tier 1 Markets;
“Timely Delivery” means, with respect to a Batch, that the COA Delivery Date occurs no later than the COA Target Date, subject to the Grace Period;
“United States” means the United States of America, its territories and possessions, including the District of Columbia and Puerto Rico; and
“Year” means each consecutive period of 12 consecutive calendar months commencing on January 1 and ending on December 31, and the last Year of the Term shall commence on January 1 of the calendar year in which the Term ends and end on the last day of the Term.
MANUFACTURING SERVICES; RELATED MATTERS
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Activity* | Timeline | Calendar Day Duration |
COA issued, loading of all completed documentation | [*****] | [*****] |
Compliance comments received from Acorda for corrections/clarification | [*****] | [*****] |
Corrections are provided back to Acorda | [*****] | [*****] |
Resolution by both parties if needed, COC issued | [*****] | [*****] |
|
|
|
| Total: | [*****] |
*Documentation can be loaded prior to COA issuance to prevent review surge |
The Parties will amend the Quality Agreement as soon as possible to conform to the timelines above.
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For clarity, nothing in this Agreement limits Acorda’s right for China (which shall mean the People’s Republic of China, including Macau and Hong Kong, and the Republic of China (Taiwan)) at any time or in the Territory in the event Manufacturer fails to achieve Timely Delivery, to manufacture Supplied Product itself or to obtain Supplied Product from a third party. In addition, in anticipation that third party manufacturing may be required or permitted in certain circumstances, Acorda may engage one or more additional sites of Acorda or third parties to manufacture Supplied Product, including to manufacture Supplied Product on a back-up basis and to produce validation batches at such site in order to obtain approval for the back-up supplier under applicable regulatory approvals.
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“Quantity Received”: The total quantity of Active Materials that complies with the Specifications and was received at the Manufacturing Site during the calendar month.
“Quantity Dispensed”: The Quantity Dispensed for the calendar month is calculated by adding the Quantity Received during the calendar month to the inventory of Active Materials that complied with the Specifications held at the beginning of the calendar month and then subtracting from the resulting sum the sum of (A) the inventory of Active Materials that complied with the Specifications held at the end of the calendar month plus [*****].
“Quantity Converted”: The total amount of Active Materials contained in the Supplied Product manufactured with the Quantity Dispensed during the calendar month (including any additional Supplied Product produced to replace Supplied Product included in failed Batches or rejected, returned or Recalled Product) delivered by Manufacturer and not rejected, returned, or Recalled (either during the calendar month or after) because of Manufacturer’s failure to perform the Manufacturing Services and deliver Supplied Product in accordance with the terms of this Agreement.
Within [*****] days after the end of each Year, Manufacturer shall give Acorda an annual reconciliation of Active Materials using the form of reconciliation report set forth in Exhibit B, including the calculation of the “Actual Annual Yield” or “AAY” for the Supplied Product at the Manufacturing Site during the Year, which will be [*****] calculated as follows:
[*****] x 100%
[*****]
For clarity, the monthly reports and annual reconciliation report referenced above, are subject to modification after they are delivered or made as necessary to take account of any subsequent rejection, return, or Recall of relevant Supplied Product by Acorda because of Manufacturer’s failure to perform the Manufacturing Services and deliver Supplied Product in accordance with the terms of this Agreement or the Quality Agreement.
Shortfall = [*****].
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If the Actual Annual Yield is higher than the Target Yield for the Supplied Product in a Year, then the bonus for the Year (the "Bonus") will be calculated as follows:
Bonus = [*****].
Each Shortfall/Bonus determined in accordance with this Section 2.7(a)(iii)) shall be summarized by Manufacturer on the annual reconciliation report referenced in Section 2.7(a)(ii).
ACORDA PAYMENTS
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AMENDMENTS TO SPECIFICATIONS OR OTHER ARRANGEMENTS
FORECASTS, ORDERS AND DELIVERY
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Timing of COA Delivery | Consequence |
COA delivery up to [*****] after COA Target Date | [*****] |
COA delivery [*****] after COA Target Date | Batch at [*****] discount |
COA delivery [*****] after COA Target Date | Batch at [*****] discount |
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COA delivery [*****] after COA Target Date | Batch at [*****] discount or [*****] |
For Bulk Product, the COA Target Date will be mutually agreed upon by Parties based on the actual data on the PSD-7 from the validation batches as modified by the Parties from time to time based on historical data. The Grace Period shall be agreed by mutual agreement of the Parties taking into account the need to further process the Bulk Product and the applicable stability data at the time. If the COA is delivered after the Grace Period, Acorda may reject the Batch and Manufacturer shall provide a replacement batch.
FAILED BATCHES; PRODUCT CLAIMS; RECALLS
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CO-OPERATION
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TERM AND TERMINATION
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REPRESENTATIONS, WARRANTIES AND COVENANTS
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REMEDIES AND INDEMNITIES
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CONFIDENTIALITY
the Party (the “Receiving Party”) receiving from the other Party (the “Disclosing Party”) Confidential Information (y) shall keep confidential, using the same level of care that the Receiving Party uses for its own Confidential Information of a similar nature, but in any event, and without prejudice to those policies, procedures and arrangements otherwise specified to be implemented and followed by the Receiving Party pursuant to this Agreement, not less than reasonable means under the circumstances, and shall not publish
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or otherwise disclose any such Confidential Information, except to those of the Receiving Party’s employees, Affiliates, or consultants who have a need to know such Confidential Information to perform such Party’s obligations or exercise or enforce such Party’s rights hereunder (and who shall be advised by the Receiving Party of the Receiving Party’s obligations hereunder and who must be bound by confidentiality obligations to the Receiving Party with respect to such Confidential Information no less onerous than those set forth in this Agreement) (collectively, “Recipients”) and (z) shall not use Confidential Information of the Disclosing Party directly or indirectly for any purpose other than performing its obligations or exercising or enforcing its rights hereunder. The Receiving Party will be jointly and severally liable for any breach by any of its Recipients of the restrictions set forth in this Agreement. Notwithstanding the foregoing, Acorda will be deemed to be the Disclosing Party, and Manufacturer the Receiving Party, with respect to any Confidential Information included in the Acorda Intellectual Property or the Acorda New Intellectual Property, regardless of which Party discloses the information.
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provided, however, that in each case, in respect of any item of the Lock Down Information, Manufacturer shall have the burden of proving the applicability of any of the foregoing exceptions that it claims applies in respect of such Know-How.
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DISPUTE RESOLUTION
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MISCELLANEOUS
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If to Acorda:
Acorda Therapeutics, Inc.
2 Blue Hill Plaza 3rd Fl.
Pearl River, New York 10965
Attn: President & CEO
with a copy (which shall not constitute notice) to:
Acorda Therapeutics, Inc.
2 Blue Hill Plaza 3rd Fl.
Pearl River, New York 10965
Attn: General Counsel
CONFIDENTIAL AGREEMENT
EXECUTION VERSION
If to Manufacturer:
Catalent Massachusetts LLC
14 Schoolhouse Road
Somerset, NJ 08873
Attn: Group President Pharma and Consumer Health
with a copy to:
Catalent Pharma Solutions
14 Schoolhouse Road
Somerset, NJ 08873
Attn: General Counsel (Legal Department)
Email: [*****]
CONFIDENTIAL AGREEMENT
EXECUTION VERSION
CONFIDENTIAL AGREEMENT
EXECUTION VERSION
[Signature page follows.]
CONFIDENTIAL AGREEMENT
EXECUTION VERSION
IN WITNESS WHEREOF, the duly authorized Representatives of the Parties have executed this Agreement as of the date first written above.
CATALENT MASSACHUSETTS LLC
By:
Name: Ricky Hopson
Title: President, Clinical Development and Supply, Catalent Pharma Solutions
ACORDA THERAPEUTICS, INC.
By:
Name: Ron Cohen
Title: President and CEO