COMMERCIAL SUPPLY AGREEMENT
Exhibit 10.1
This Commercial Supply Agreement (including Exhibit 1 hereto, this “Agreement”) is entered into as of February 26, 2021 (the “Effective Date”) by and between:
Kiniksa Pharmaceuticals (UK), Ltd., a company incorporated under the laws of England and Wales having its registered office at Third Floor, 00 Xxx Xxxx Xxxxxx, Xxxxxx X0X 0XX, Xxxxxxx (“KINIKSA”),
and
Regeneron Pharmaceuticals, Inc., a company organized under the laws of New York and having a principal place of business at 000 Xxx Xxx Xxxx Xxxxx Xxxx, Xxxxxxxxx, Xxx Xxxx 00000 (together with its Affiliates “REGENERON”).
With each of KINIKSA and REGENERON collectively referred to as the “Parties” and individually as a “Party”.
RECITALS
Whereas, REGENERON is a biopharmaceutical company engaged in the field of discovery, development, manufacture and commercialization of biopharmaceutical products;
Whereas, KINIKSA is engaged in the development, manufacture and commercialization of biopharmaceutical products;
Whereas, Kiniksa Pharmaceuticals, Ltd. and REGENERON have entered into a License Agreement dated as of September 25, 2017 (the “License Agreement”);
Whereas, as of January 7, 2021, Kiniksa Pharmaceuticals, Ltd. has assigned the License Agreement to KINIKSA as part of a sale of assets relating to the Product;
Whereas, pursuant to the terms of the License Agreement, REGENERON intends to Manufacture and supply and KINIKSA intends to purchase Formulated Bulk Product and Filled Drug Product as set forth in this Agreement;
NOW, THEREFORE, in consideration of the foregoing, of the mutual covenants and undertakings contained herein and of other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, hereby agree as follows.
ARTICLE 1
DEFINITIONS AND INTERPRETATION
All capitalized terms not otherwise defined herein have the meanings ascribed to them set forth in the License Agreement. For the purposes of this Agreement, the following words and phrases shall have the
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Exhibit 10.1
meanings ascribed to them below, even if different than the meanings ascribed to them in the License Agreement.
“Batch” shall mean a specific quantity of Formulated Bulk Product or Filled Drug 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 and regulatory submissions. For purposes of this Agreement, (a) a Batch of Formulated Bulk Product is [***] Liter bioreactor production run and (b) a Batch of Filled Drug Product results in any number of vials within the validated batch size range (i.e., a minimum of [***] vials and a maximum of [***] vials, as of the Effective Date).
“Business Day” shall mean any day other than a Saturday, a Sunday or a day on which commercial banks in New York, NY, USA, are authorized or required by Law to remain closed.
“Binding Forecast” has the meaning set forth in Section 5.3(a) below.
“Clinical Supply Agreement” shall mean the Clinical Supply Agreement between REGENERON and Kiniksa Pharmaceuticals, Ltd. effective September 27, 2017.
“CMO” or “Contract Manufacturing Organization” shall mean a company engaged by REGENERON to perform the filling of the Formulated Bulk Product.
“Delivery” shall mean the date REGENERON makes Product available to KINIKSA and the following have been achieved: (i) the Product has beforehand been released by REGENERON’s quality control unit; (ii) KINIKSA has received the Batch Documentation (as defined in the Quality Agreement) signed by an authorized representative of REGENERON in accordance with the Quality Agreement, in addition to any other documentation required or specified in the Quality Agreement; and (iii) the representations and warranties set forth in Section 10.3 of this Agreement are true with respect to the Product being made available to KINIKSA hereunder.
“Delivery Date” shall mean the calendar day of delivery specified by KINIKSA in a Purchase Order in accordance with Section 5.4 and as agreed to by REGENERON.
“DS Facility” shall mean REGENERON’s drug substance manufacturing site as identified in regulatory submissions for Product, which is, as of the Effective Date, located at 00 Xxxxxxxx Xxxxxxxx Xxxxxxxxxx, XX 00000.
“Filled Drug Product” shall mean Product filled in vials, before their labeling and packing for sale to the market in the Territory.
“Formulated Bulk Product” shall mean Product formulated into solution at the DS Facility that is ready for storage or shipment to KINIKSA or to KINIKSA’s designee to allow for further processing.
“Force Majeure Event” shall have the meaning set forth in Section 12.6.
“Good Practices” shall mean compliance with the applicable standards contained in then-current “Good Laboratory Practices,” “Good Manufacturing Practices” or “Good Clinical Practices,” as promulgated by the FDA and all analogous guidelines promulgated by the EMA or the ICH, or other country Regulatory Authorities, as applicable.
“Law” or “Laws” shall mean any and all federal, state, local, national, and supra-national laws, statutes, rules, regulations, treaties, orders, judgments, injunctions or ordinances of any Governmental Authority, including any rules, regulations, guidelines, or other requirements of any Regulatory Authority, in each case, that may be in effect from time to time and applicable to the activities under this Agreement.
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Exhibit 10.1
“Manufacture” or “Manufacturing” shall mean all activities directed to producing, manufacturing, processing, filling, finishing, quality assurance, quality control, testing and release, shipping and storage of Formulated Bulk Product or Filled Drug Product.
“Manufacturing Process” shall mean all the Manufacturing operations performed under the responsibility of REGENERON.
“Minimum Shelf Life” unless the Parties have agreed otherwise in writing, shall mean (a) Formulated Bulk Product with a minimum of [***] months remaining shelf life from the date made available to KINIKSA for Delivery, and (b) Filled Drug Product with a minimum of [***] months remaining shelf life from the date made available to KINIKSA for Delivery; provided, however, that in either case, if the total potential shelf life for Product is extended by an applicable Regulatory Authority, then the Parties shall discuss and consider in good faith extending the Minimum Shelf Life for such Product by an agreed upon amount and in accordance with the Quality Agreement and shall document any resulting agreement through a written amendment to this Agreement.
“Non-Conforming Product” shall mean, with respect to any Product: (a) any failure to conform to the Specifications set forth in the Quality Agreement; or (b) that the Product was not manufactured in accordance with GMP and applicable Law.
“Product” shall mean any pharmaceutical product, drug product, preparation, formulation, or dosage form thereof that has rilonacept [***], including the pharmaceutical product for human use, containing rilonacept and developed or commercialized by REGENERON in the U.S. (known as ARCALYST® (rilonacept) Injection for Subcutaneous Use in the United States) [***]. Product shall either be Filled Drug Product or Formulated Bulk Product, unless otherwise agreed by the Parties. As used herein, Product shall also include any reference standard purchased by KINIKSA pursuant to Section 6.5.
“Purchase Order” shall mean a written KINIKSA purchase order which, upon acceptance in writing by REGENERON, shall constitute a non-cancellable, legally binding commitment on the part of KINIKSA to purchase the quantity of Product set forth in such purchase order, the form of which is attached hereto as Exhibit 1.
“Quality Agreement” shall mean the quality agreement entered into between the Parties, as may be amended from time to time, which (i) sets forth the Specifications, and the quality requirements for the Manufacture and supply of Product by REGENERON or on behalf of REGENERON to KINIKSA in accordance with Good Practices, and (ii) defines the roles and responsibilities of the Parties and their respective Affiliates and subcontractors with regard to importation in the European Union, quality testing, certification and other quality matters.
“Specifications” shall mean the mutually agreed and written list of tests, references to analytical procedures, and appropriate acceptance criteria or other criteria for tests according to which Product Manufactured by or on behalf of REGENERON hereunder must conform to be considered acceptable for its intended use.
“Term” shall have the meaning set forth in Section 9.1.
“Territory” means all the countries and territories of the world, other than the Retained Territory.
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Exhibit 10.1
ARTICLE 2
PRODUCT COVERED BY THIS AGREEMENT
The purpose of this Agreement is to set forth the terms and conditions whereby, during the Term, KINIKSA shall order, and REGENERON shall use Commercially Reasonable Efforts to Manufacture (or have Manufactured) and supply (or have supplied), KINIKSA’s requirements (as set forth in the Binding Forecast(s)) for Formulated Bulk Product or Filled Drug Product, as the case may be. KINIKSA may use Product purchased pursuant to this Agreement for Development or Commercialization activities. This Agreement applies to Purchase Orders placed pursuant to this Agreement after the Effective Date and does not apply to Purchase Orders placed pursuant to the Clinical Supply Agreement.
ARTICLE 3
GENERAL OBLIGATIONS
3.1Manufacturing Requirements; Duty to Advise
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3.2Product; Changes in Manufacturing
Any of a Party’s obligations identified herein or in the Quality Agreement can, at such Party’s discretion, be performed by any of its Affiliates, and any of a Party’s rights hereunder or under the Quality Agreement can also be executed by any of such Party’s Affiliates, provided that, as contemplated by and without limitation of Sections 17.9.2, 17.9.3 and 17.9.4 of the License Agreement, such Affiliate agrees in writing to be bound by the terms and conditions of this Agreement.
ARTICLE 4
LICENCES / APPROVALS
Upon the terms and subject to the conditions hereof, each Party will use Commercially Reasonable Efforts to (a) obtain from the requisite Governmental Authorities any consents, licenses, permits, waivers, approvals, authorizations or orders required to be obtained or made by such Party in connection with the authorization, execution and delivery by such Party of this Agreement and the performance by such Party of its obligations hereunder, and (b) make all necessary filings, and thereafter make any other advisable submissions, required to be made by such Party under applicable Laws with respect to this Agreement or such Party’s performance of its obligations hereunder. The Parties will reasonably cooperate with each other in connection with the making of all such filings, including by providing copies of all such non-confidential documents to the other Party prior to the filing and, if requested, by considering all reasonable additions, deletions or changes suggested by the other Party in connection therewith.
ARTICLE 5
FORECASTS AND DELIVERY
5.1Supply Chain Management
Each Party shall, forthwith upon execution of this Agreement, appoint one (1) of its employees to be a point of contact responsible for acting as liaison between the Parties with regard to the supply chain
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Exhibit 10.1
matters described in this Agreement. The points of contact shall meet (either in person or by phone) on a monthly basis or such other frequency as the points of contact may agree upon, but in any event not less frequently than every three (3) months, to review the current status of the supply relationship. Additional subject matter experts shall be available for participation in these meetings as needed. The points of contact will use Commercially Reasonable Efforts to address forecasting and production planning matters jointly.
5.2Forecasts and Order Quantity
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Exhibit 10.1
5.3REGENERON’s Forecast Obligations
(a)No later than [***] calendar days after receipt of KINIKSA’s Long-Term Forecast, REGENERON shall accept or reject in writing such Long-Term Forecast. Upon REGENERON’s written acceptance of a Long-Term Forecast, it shall become binding (the “Binding Forecast”) with respect to (i) the Formulated Bulk Product, for a period of the first [***] months of such Long-Term Forecast, and (ii) the Filled Drug Product for a period of the first [***] months of such Long-Term Forecast.
(b) Notwithstanding Section 5.3(a), REGENERON shall have [***] Business Days to accept or reject the amounts set forth in the newly added (i.e., the last) time periods of each Binding Forecast, and REGENERON will [***] such amounts if they are consistent with the amounts set forth in the corresponding time periods of the Long-Term Forecast that was submitted and accepted by REGENERON in the prior calendar quarter.
(c)If REGENERON rejects any Long-Term Forecast, including any rejection relating to the Binding Forecast, then when REGENERON provides its written notice of rejection, it shall also provide a written explanation as to what was not acceptable. The Parties shall use Commercially Reasonable Efforts to reach a mutually agreeable solution, such as where possible, bringing forward or postponing a portion of the non-binding Long-Term Forecast, such that KINIKSA may submit a Long-Term Forecast that REGENERON will accept. For the sake of clarity, REGENERON may not reject any portion of the Binding Forecast that REGENERON had already accepted as part of a previously submitted and accepted Long-Term Forecast.
5.4 Purchase Orders
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Exhibit 10.1
5.5 Delivery
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Exhibit 10.1
ARTICLE 6
QUALITY CONTROL OF PRODUCTS
6.1Personnel and Facilities
(a)REGENERON shall provide, and ensure that its CMOs provide, the necessary expertise, adequately skilled and trained personnel, facility and equipment to carry out its obligations under this Agreement, and it shall use Commercially Reasonable Efforts to maintain all Manufacturing facilities in compliance with Good Practices, applicable Law and the manufacturing license for Product.
(b)Throughout the Term, REGENERON will provide directly, or indirectly through written contract with a CMO, appropriately qualified and trained personnel, adequate premises and space, suitable equipment and services, correct materials, containers and labels, suitable storage, and the knowledge and experience to carry out its obligations under this Agreement.
(c)REGENERON owns or lawfully controls the DS Facility. During the Term, REGENERON will ensure that that the DS Facility and any CMO Manufacturing facility is maintained in accordance with Good Practices and all applicable Laws and in such condition as to enable Product to be Manufactured in compliance with Good Practices, all applicable Law, and the Quality Agreement.
(d)The terms and conditions of KINIKSA’s audit rights and rights to inspect the facilities involved in Manufacturing the Formulated Bulk Product are provided in the Quality Agreement.
(e)During Manufacture of Formulated Bulk Product, REGENERON will permit [***] to observe GMP manufacturing of intermediates and Formulated Bulk Product. [***] must be accompanied by REGENERON personnel at all times and abide by all of REGENERON’s policies and other requirements. In advance of [***] visit, KINIKSA must obtain written permission from REGENERON in order to be allowed [***] or to send [***] to REGENERON’s site, provided that such permission shall not be unreasonably withheld or delayed.
(f)During Manufacture of Filled Drug Product, REGENERON shall take reasonable commercial efforts to ensure that REGENERON’s subcontractor will permit a REGENERON “person in plant” to oversee GMP Manufacturing Activities at the subcontractor’s facility. To the extent mutually agreeable with such subcontractor, REGENERON and KINIKSA, a KINIKSA employee may accompany the REGENERON “person in plant” for such portion or portion(s) of oversight, as applicable.
All information, data, documentation, and reports produced by or on behalf of REGENERON in the conduct of Manufacturing Product or all other GMP documentation relating to Product will be prepared by REGENERON using REGENERON’s SOPs.
6.3Quality Control; Disputes
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Exhibit 10.1
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Exhibit 10.1
6.4Limitation Period for Certain Claims
The limitation period for all claims by KINIKSA related to defective or Non-Conforming Products is [***] months from the Delivery Date, provided that this Section 6.4 shall not alter the time periods set forth in Section 6.3 within which KINIKSA must notify REGENERON of Product defects or non-conformity or the effect of a failure by KINIKSA to timely give such notice.
6.5 Reference Standards
From time to time at KINIKSA’s reasonable request, REGENERON shall provide to KINIKSA the list of suppliers for reference standards required for the testing by KINIKSA of the Product, and, in case there is no commercially available supplier of any given reference standard, REGENERON shall supply KINIKSA with such reasonable quantities of reference standard as reasonably requested by KINIKSA, at a price equal to REGENERON’s Fully-Burdened Costs and under reasonable lead-time as agreed between the Parties.
ARTICLE 7
PRICE AND PAYMENT TERMS
7.1Price
The price for the specific Product delivered by REGENERON to KINIKSA pursuant to a Purchase Order that meets all of the requirements of this Agreement shall be the [***] for such Product and paid in accordance with the [***], as set forth in Section 9.4.2(a) of the License Agreement (Kiniksa Payment to Regeneron for Product Supplied under the Supply Agreement) and the [***] as set forth in Section 9.4.2(b) of the License Agreement [***] (if any) for such period, [***], subject however, to any adjustments set forth in Section 6.3 hereof.
7.2Invoicing
In accordance with Section 8.6 of the License Agreement (Price for Product Supplied by Regeneron), for Product ordered pursuant to a Purchase Order submitted in accordance with Section 5.4 (Purchase Orders), REGENERON shall invoice KINIKSA for the [***] concurrently with the Delivery of the Product to Kiniksa.
7.3Payment Terms
Payment terms applicable to Product deliveries and invoices shall be determined as set forth in Section 9.4.2 of the License Agreement (Reimbursement of Manufacturing Costs). REGENERON shall issue invoices for Product upon Delivery of such Product. Notwithstanding the foregoing, until the [***] year anniversary of the Effective Date, if REGENERON Delivers [***] between [***] and [***] days prior to the Delivery Date set forth in the Purchase Order pursuant to Section 5.5(a), then KINIKSA shall pay for such [***] no later than [***] days after KINIKSA’s receipt of an invoice for such [***].
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Exhibit 10.1
7.4Late Payments
Any late payments for Products delivered or produced hereunder shall be subject to Section 9.7 of the License Agreement (Late Payments) and Section 9.9 of the License Agreement (Resolution of Payment Disputes).
7.5Cancellation of Purchase Orders
The Purchase Order acceptance by REGENERON of any quantity of Product ordered shall constitute a legally binding commitment on the part of KINIKSA to purchase the quantity of Product set forth therein; provided, however, that in the event that KINIKSA cancels all or any portion of any Purchase Orders, KINIKSA may be obligated to pay to REGENERON as set forth above in Section 5.4(d). REGENERON will, however, in good faith, exert Commercially Reasonable Efforts to fill the excess capacity or use other mitigating measures in order to reduce the Manufacturing Costs for which KINIKSA might be liable.
7.6Currency
All payments under this Agreement shall be made in US Dollars.
7.7Taxes
Taxes shall be addressed in accordance with the License Agreement.
Confidentiality shall be governed under the terms of the License Agreement in the confidentiality provisions and the related definitions shall be deemed to also refer to this Agreement for purposes of this ARTICLE 8.
9.1Term
This Agreement shall commence on the Effective Date and shall remain in force for the earlier to occur of (i)expiration or termination of the License Agreement or (ii) the date of the completion of a Manufacturing Technology Transfer Event as set forth in a Technology Transfer Agreement, which may take the form of a Statement of Work, attachment to this Agreement, or other separate agreement.
9.2Termination
Except as otherwise provided in Article 16 of the License Agreement (Term and Termination) and Section 12.11 of this Agreement (Survival), upon termination of this Agreement, the rights and obligations of each Party hereunder shall terminate, and this Agreement shall cease to be of further force or effect.
ARTICLE 10
SUPERIORITY; WARRANTIES; INDEMNITY
10.1Superiority
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Exhibit 10.1
No provision in KINIKSA’s Purchase Order, or in REGENERON’s confirmation or acceptance of a Purchase Order, general conditions of sale or invoice, which may purport to impose different conditions upon KINIKSA or REGENERON, shall modify or otherwise alter the terms of this Agreement.
10.2Warranties and Limitations of Liability
In addition to the additional warranties and any limitation of liability terms included herein, the warranties and limitations of liability of REGENERON and KINIKSA shall be governed by the warranty and limitation of liability terms set forth in the License Agreement.
10.3General Warranties
REGENERON represents and warrants that (a) Product supplied under this Agreement to KINIKSA (i) shall be Manufactured in accordance with the Specifications and quality requirements set forth in the Quality Agreement and all Laws, including GMP, (ii) shall be free of any defects in any materials or workmanship, (iii) shall be stored and supplied in conformity with the Specifications and all Laws, including GMP, (iv) shall meet the Minimum Shelf Life requirements for such Product at the time of Delivery, provided that if REGENERON Delivers Filled Drug Product early pursuant to Section 5.5(a), such Filled Drug Product must meet the Minimum Shelf Life requirement as of the Delivery Date set forth in the Purchase Order, and (v) shall not contain any material provided by or on behalf of REGENERON that has not been used or stored in accordance with the Specifications and Laws, including GMP; (b) it will not introduce any materials not provided in the Specifications that would cause the applicable Product to be adulterated or misbranded within the meaning of Sections 501 or 502 of the U.S. Federal Food, Drug and Cosmetics Act and the regulations promulgated thereunder; and (c) it shall perform all obligations hereunder in compliance with all Laws and industry standards of workmanship and professionalism.
10.4Indemnity & Insurance
Indemnity and insurance shall be governed by the terms set forth in Article 14 of the License Agreement (Indemnity).
ARTICLE 11
ASSIGNMENT
Subject to Section 3.3 (Performance by Affiliates) hereof, neither Party shall transfer, assign or delegate this Agreement, or any rights or obligations hereunder, in whole or in part, without the other Party’s prior written consent, except (a) to an Affiliate of the transferring, assigning or delegating Party, or (b) in connection with the assignment of the License Agreement in compliance with Section 17.9.1 of the License Agreement (Assignment to Third Parties by Kiniksa). Any purported transfer, assignment or delegation not in compliance with this Article 11 shall be void and of no effect.
ARTICLE 12
MISCELLANEOUS
12.1 Severability
If any provision of this Agreement or the application thereof to any Party or circumstances is held invalid, such invalidity shall not affect other provisions or applications of this Agreement which can be given effect without the invalid provision or application and to this end the provisions or applications of this Agreement are declared to be severable. In lieu of any invalid, prohibited or unenforceable provision or
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Exhibit 10.1
application thereof, the Parties or a court (if applicable) shall substitute suitable or equitable terms to carry out the intent of this Agreement.
12.2Amendments; Waivers
Any waiver, amendment or modification of this Agreement is unenforceable unless made in a written document executed by duly authorized representatives of both KINIKSA and REGENERON. The waiver by either Party hereto of any right hereunder or the failure to perform or of a breach by the other Party will 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.
12.3 Relationship of the Parties
Neither KINIKSA nor REGENERON shall have any responsibility for the hiring, termination or compensation of the other Party’s employees or for any employee compensation or benefits of the other Party’s employees. No employee or representative of a Party shall have any authority to bind or obligate the other Party to this Agreement for any sum or in any manner whatsoever, or to create or impose any contractual or other liability on the other Party without said Party’s approval. For all purposes, and notwithstanding any other provision of this Agreement to the contrary, REGENERON’s legal relationship under this Agreement to KINIKSA, and KINIKSA’s legal relationship under this Agreement to REGENERON, shall be that of an independent contractor. Nothing in this Agreement shall be construed to establish an employment, agency, joint venture, or partnership between the Parties or any of their respective Affiliates. For purposes of this Agreement, as of the Effective Date, neither KINIKSA nor any of its Affiliates is an Affiliate of REGENERON or any of its Affiliates, and neither REGENERON nor any of its Affiliates is an Affiliate of KINIKSA or any of its Affiliates.
12.4 Parties in Interest
This Agreement shall inure to the benefit of and be binding upon the Parties and their respective permitted successors and assigns. Nothing in this Agreement, express or implied, is intended to confer on any person other than the Parties, or their respective successors or assigns, any rights, remedies, obligations or liabilities under or by reason of this Agreement.
12.5 Compliance with Laws.
In the performance of this Agreement, both Parties agree to comply with all applicable Laws.
12.6 Force Majeure
Without limiting the terms of Section 8.13 (Notification and Discussion of Supply Issues) and Section 8.14 (Manufacturing Technology Transfer Event) of the License Agreement, a delay or failure of either Party to perform its obligations under this Agreement will be excused to the extent that the delay or failure was caused directly by an event beyond such Party’s control, without such Party’s fault or negligence and that by its nature could not have been foreseen by such Party or, if it could have been foreseen, was unavoidable (which events may include natural disasters, embargoes, explosions, riots, wars or acts of terrorism, pandemic (including without limitation the COVID-19 pandemic and any iterations of such pandemic) (each, a “Force Majeure Event”). A Party’s financial inability to perform, changes in cost or availability of materials, components or services, market conditions or supplier actions or contract disputes will not excuse performance under this Section 12.6. REGENERON shall give KINIKSA prompt written notice of any event or circumstance that is reasonably likely to result in a Force Majeure Event and the anticipated duration of such Force Majeure Event. REGENERON shall use
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Exhibit 10.1
Commercially Reasonable Efforts to end the Force Majeure Event, ensure that the effects of any Force Majeure Event are minimized and resume full performance under this Agreement.
12.7Notices
Any consent, notice or report required or permitted to be given or made under this Agreement by one of the Parties to the other shall be in writing, delivered personally or by first class air mail or nationally recognized courier, postage prepaid (where applicable), addressed to such other Party at its address indicated below, or to such other address as the addressee shall have last furnished in writing to the addressor and (except as otherwise provided in this Agreement) shall be effective upon receipt by the addressee.
If to REGENERON:
Regeneron Pharmaceuticals, Inc.
000 Xxx Xxx Xxxx Xxxxx Xxxx
Xxxxxxxxx, Xxx Xxxx 00000
Attention: General Counsel
With a copy to:
Regeneron Pharmaceuticals, Inc.
0 Xxxxxx Xxxx
Xxxx, XX 00000
Attention: Assistant General Counsel
If to KINIKSA:
Kiniksa Pharmaceuticals (UK), Ltd.
Third Floor
00 Xxx Xxxx Xxxxxx
Xxxxxx X0X 0XX
Xxxxxxx
Attn: Legal Department
With a copy to:
Kiniksa Pharmaceuticals Corp.
000 Xxxxxx Xxxxxx
Xxxxxxxxx, XX 00000
Attn: Legal Department
12.8Governing Law and Jurisdiction.
This Agreement shall be governed by and construed in accordance with the laws of the State of New York, without regard to the conflict of laws principles thereof that would require the application of the law of any other jurisdiction. Except for Financial Disputes which are governed by Section 17.1.2 of the License Agreement (Financial Disputes), the Parties irrevocably and unconditionally submit to the exclusive jurisdiction of the United States District Court for the Southern District of New York solely and specifically for the purposes of any action or proceeding arising out of or in connection with this Agreement.
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Exhibit 10.1
The captions to the several Articles and Sections of this Agreement are included only for convenience of reference and shall not in any way affect the construction of, or be taken into consideration in interpreting, this Agreement. In this Agreement: (a) the word “including” shall be deemed to be followed by the phrase “without limitation” or like expression; (b) references to the singular shall include the plural and vice versa; (c) references to masculine, feminine and neuter pronouns and expressions shall be interchangeable; (d) the words “herein” or “hereunder” relate to this Agreement; (e) the words “shall” and “will” have the same meaning; (f) references to a particular statute or regulation include all rules and regulations thereunder and any predecessor or successor statute, rules or regulation, in each case as amended or otherwise modified from time to time; (g) words in the singular or plural form include the plural and singular form, respectively; (h) references to a particular person include such person’s successors and assigns to the extent not prohibited by this Agreement; (i) unless otherwise specified, “$” is in reference to United States dollars; and (j) the word “or” has the inclusive meaning represented by the phrase “or/and.” Each accounting term used herein that is not specifically defined herein shall have the meaning given to it under GAAP, but only to the extent consistent with its usage and the other definitions in this Agreement.
12.10Construction.
The Parties acknowledge and agree that: (a) each Party and its counsel reviewed and negotiated the terms and provisions of this Agreement and have contributed to its revision; (b) the rule of construction to the effect that any ambiguities are resolved against the drafting Party will not be employed in the interpretation of this Agreement; and (c) the terms and provisions of this Agreement will be construed fairly as to each Party and not in a favor of or against either Party, regardless of which Party was generally responsible for the preparation of this Agreement. The headings of clauses contained in this Agreement preceding the text of the sections, subsections, and paragraphs hereof are inserted solely for convenience and ease of reference only and shall not constitute any part of this Agreement, or have any effect on its interpretation or construction. This Agreement has been prepared in the English language and the English language shall control its interpretation. In addition, all notices required or permitted to be given hereunder, and all written, electronic, oral, or other communications between the Parties regarding this Agreement shall be in the English language.
12.11Survival.
Subject to the limitations and other provisions of this Agreement: (a) the representations and warranties of the Parties contained herein will survive the expiration or earlier termination of this Agreement; and (b) Article 1 (Definitions and Interpretation), Article 8 (Confidentiality), Article 9 (Term and Termination), Article 10 (Superiority; Warranties; Indemnity), Article 12 (Miscellaneous), Section 6.3(g), and Section 6.4 (Limitation Period for Certain Claims) of this Agreement, as well as any other provision that, in order to give proper effect to its intent, should survive such expiration or termination, will survive the expiration or earlier termination of this Agreement. All other provisions of this Agreement will not survive the expiration or earlier termination of this Agreement.
Nothing contained in this Agreement shall deny any Party the right to seek injunctive or other equitable relief from a court of competent jurisdiction in the context of a bona fide emergency or prospective irreparable harm.
12.12 Counterparts.
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. | Page | 16 |
Exhibit 10.1
This Agreement may be executed in counterparts, each of which shall be deemed an original, shall be construed together and shall constitute one and the same instrument.
[Remainder of page intentionally left blank; Signature page follows]
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. | Page | 17 |
Exhibit 10.1
IN WITNESS WHEREOF, the Parties have caused this Agreement to be signed by their duly authorized corporate officers, on the dates indicated below.
Kiniksa Pharmaceuticals (UK), Ltd. | Regeneron Pharmaceuticals, Inc. |
__/s/ Xxxx Moat____________________ | __/s/ Xxxxx Oberman_____________________ |
Name: Xxxx Xxxx | Name: Xxxxx Xxxxxxx |
Title: Director | Title: Vice President, Supply Chain Operations |
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. | Page | 18 |
