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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***],
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT
MANNKIND CORPORATION TREATS AS PRIVATE OR CONFIDENTIAL.
SEVENTH AMENDMENT TO SUPPLY
amendment ( Seventh Amendment ) to the Supply Agreement by and between MannKind Corporation ( MannKind ) and Amphastar Pharmaceuticals, Inc. ( Amphastar ), originally dated July 31, 2014 and as
previously amended on October 31, 2014, November 9, 2016 , April11, 2018, December 24, 2018, August 2, 2019 , and May 24, 2021, (collectively, the Agreement ), is hereby made as of
the December 22, 2023, by and between MannKind on the one hand, and on the other hand, Amphastar.
WHEREAS, MannKind and Amphastar entered into the Agreement pursuant to which Amphastar is to manufacture and supply the Product to
MannKind, and MannKind is to purchase certain minimum quantities of the Product; and
WHEREAS MannKind and Amphastar have
determined it to be mutually beneficial to amend the Agreement as set forth herein.
NOW, THEREFORE, for good and valuable
consideration, MannKind and Amphastar hereby agree to amend the Agreement as follows:
1. Definitions. Unless otherwise
defined herein, each of the capitalized terms used in this Seventh Amendment shall have the definition and meaning ascribed to it in the Agreement.
2. The definitions in Section 1 of the Agreement are amended by adding the following provisions at the end of
Section 1 and not in alphabetical order:
2.1. New Section 1.16 is added as follows: Capacity Fee means
the amount MannKind will pay to Amphastar France Pharmaceuticals ( AFP ) every calendar quarter. The Capacity Fee is for a full calendar quarter, including the calendar quarter that MannKind receives FDA approval
for MannKind to use the Product produced with inclusion bodies that are manufactured by Amphastar. For example, if FDA approval is on Feb. 15, 2026, then the full Capacity Fee for the first calendar quarter is due in accordance with
the table in Section 6.1, following which Year 1 would start on April 1, 2026.
2.2. New Section 1.17 is added
as follows: Year 1 means the year that starts on the first day of the calendar quarter after MannKind receives FDA approval to use the Product produced with inclusion bodies that are manufactured by Amphastar. For example,
if such FDA approval is on February 15, then Year 1 will commence on the subsequent April 1 and will end on March 31 of the following year. Year 2, 3, and so on, will be 12-month
periods that commence on each anniversary of Year 1.
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***],
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT
MANNKIND CORPORATION TREATS AS PRIVATE OR CONFIDENTIAL.
3. The table in Section 6.1 of Agreement, shall be deleted
and replaced in its entirety with the following:
| No. | Period | Annual Purchase Commitment Quantities (kg) | Purchase Price (per gram) | RHI | Delivery/ Payment | Capacity Fee | ||||||
| 1 | Q1-2024 | [***] | EURO [***] | Product produced with inclusion bodies manufactured by Amphastar | Q1-2024 | 0 | ||||||
| 2 | Q2-2024 | [***] | EURO [***] | Current FDA Approved Product | Q2-2024 | 0 | ||||||
| 3 | Q3-2024 | 0 | 0 | |||||||||
| 4 | Q4-2024 | 0 | 0 | |||||||||
| 5 | Q1-2025 | 0 | 375,000 | |||||||||
| 6 | Q2-2025 | 0 | 375,000 | |||||||||
| 7 | Q3-2025 | 0 | 375,000 | |||||||||
| 8 | Q4-2025 | 0 | 375,000 | |||||||||
| 9 | Q1-2026 and each quarter until FDA approval | 0 | 750,000/quarter until MannKind resumes purchasing Product | |||||||||
| 10 | Year 1 | [***] kg per Year | EURO [***] | Product produced with inclusion bodies manufactured by Amphastar | Purchased in equal quarterly amounts | 2,000,000 per Year, payable in equal quarterly installments | ||||||
| 11 | Year 2 to Year 5 | [***] kg per Year | EURO [***] | Product produced with inclusion bodies manufactured by Amphastar | Purchased in equal quarterly amounts | 1,000,000 per Year, payable in equal quarterly installments | ||||||
| 12 | Year 6 to Year 9 | [***] kg per Year for Year 6-8; [***] kg per Year in Year 9 | EURO [***] | Product produced with inclusion bodies manufactured by Amphastar | Purchased in equal quarterly amounts | 500,000 per Year, payable in equal quarterly installments |
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***],
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT
MANNKIND CORPORATION TREATS AS PRIVATE OR CONFIDENTIAL.
4. Section 10.1 of the Agreement shall be extended until the later of
(a) December 31, 2035 or (b) until the completion of total Purchase Commitment Quantities as provided in the table of Section 6.1. All other terms and conditions in Section 10.1 shall remain in full force and effect.
5. Final Agreement. From and after the execution of this Seventh Amendment, all references in the Agreement (or in the Seventh
Amendment) to this Agreement, hereof, herein, hereto, and similar words or phrases shall mean and refer to the Agreement as amended by this Seventh Amendment. The Agreement as amended by this Seventh
Amendment constitutes the entire agreement by and between the Parties as to the subject matter hereof. Except as expressly modified by this Seventh Amendment, all other terms and conditions of the Agreement shall remain in full force and effect.
IN WITNESS WHEREOF, each of MannKind and Amphastar has caused this Seventh Amendment to be executed by their duly authorized
| MannKind Corporation | Amphastar Pharmaceuticals, Inc. | |||||||
| By: | /s/ Michael Castagna | By: | /s/ Jacob Liawatidewi | |||||
| Name: | Michael Castagna | Name: | Jacob Liawatidewi | |||||
| Title: | CEO | Title: | EVP Corporate Administration |