Kiniksa Pharmaceuticals Ltd. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Financial Statements and Exhibits
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Kiniksa Pharmaceuticals, Ltd.
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Kiniksa Pharmaceuticals Corp.
100 Hayden Avenue
Lexington, MA, 02421
(781) 431-9100
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Item 1.01. Entry into a Material Definitive Agreement
On June 25, 2024, a wholly-owned subsidiary of Kiniksa Pharmaceuticals, Ltd. (the “Company”) entered into a Master Services Agreement (the “MSA”) and Product Specific Agreement (the “PSA” and, together with the MSA, the “Agreement”) with Samsung Biologics Co., Ltd. (“Samsung”) pursuant to which Samsung will perform technology transfer, process performance qualification, manufacturing and supply services for the supply of the Company’s ARCALYST (rilonacept) drug substance (the “Product”).
Under the PSA, the Company committed to purchase process performance qualification and pre-approval inspection batches of the Product, which may be used for regulatory submissions and, pending regulatory approval, commercial sale. In addition, the Company is obligated to purchase additional batches of the Product in the five-year period of 2027 through 2031. The PSA will continue until the later of December 31, 2031 or the completion of the services thereunder, unless the PSA is terminated earlier. Prior to the expiration of the PSA, the parties have agreed to use commercially reasonable efforts to negotiate in good faith and enter into a new PSA that would govern future manufacturing and supply services for the Product.
The MSA will have an initial term of ten (10) years and shall automatically renew for terms of two (2) years each unless either party gives the other party written notice of termination at least eighteen (18) months prior to the end of the then-current MSA term, provided that the MSA will remain in effect for so long as any product specific agreement is in effect.
Either party may terminate the MSA or PSA in the event of a material breach by the other party that is not cured within 30 days’ written notice or in the event of insolvency. The parties may also terminate the PSA if a force majeure event continues for more than 180 consecutive days and the parties are unable to negotiate a mutually satisfactory solution.
The Agreement includes customary indemnification, intellectual property protection, limitation of liability, and confidentiality provisions.
The foregoing descriptions of the MSA and PSA are qualified in their entirety by reference to the MSA and PSA, redacted copies of which will be filed as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
Description | |
| 104 | Cover Page Interactive Data File (embedded within the inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| KINIKSA PHARMACEUTICALS, LTD. |
| Date: June 25, 2024 | By: | /s/ Madelyn Zeylikman |
| Madelyn Zeylikman | ||
| Senior Vice President, General Counsel and Secretary |