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As Of Filer Filing For·On·As Docs:Size Issuer Filing Agent 2/23/23 Mannkind Corp. 10-K 12/31/22 135:24M ActiveDisclosure/FA |
Document/Exhibit Description Pages Size 1: 10-K Annual Report HTML 5.04M 2: EX-10.42 Material Contract HTML 190K 3: EX-10.43 Material Contract HTML 216K 4: EX-10.49 Material Contract HTML 56K 5: EX-10.50 Material Contract HTML 45K 6: EX-10.51 Material Contract HTML 48K 7: EX-10.52 Material Contract HTML 646K 8: EX-10.53 Material Contract HTML 71K 9: EX-23.1 Consent of Expert or Counsel HTML 36K 10: EX-31.1 Certification -- §302 - SOA'02 HTML 40K 11: EX-31.2 Certification -- §302 - SOA'02 HTML 40K 12: EX-32.1 Certification -- §906 - SOA'02 HTML 39K 13: EX-32.2 Certification -- §906 - SOA'02 HTML 39K 19: R1 Document and Entity Information HTML 106K 20: R2 Consolidated Balance Sheets (Parenthetical) HTML 54K 21: R3 Consolidated Balance Sheets HTML 151K 22: R4 Consolidated Statements of Operations HTML 136K 23: R5 Consolidated Statements of Comprehensive Loss HTML 57K 24: R6 Consolidated Statements of Stockholders' Deficit HTML 190K 25: R7 Consolidated Statements of Cash Flows HTML 204K 26: R8 Description of Business HTML 43K 27: R9 Summary of Significant Accounting Policies HTML 167K 28: R10 Acquisitions HTML 114K 29: R11 Investments HTML 156K 30: R12 Accounts Receivable HTML 101K 31: R13 Inventories HTML 58K 32: R14 Property and Equipment HTML 102K 33: R15 Goodwill and Other Intangible Asset HTML 55K 34: R16 Accrued Expenses and Other Current Liabilities HTML 105K 35: R17 Borrowings HTML 154K 36: R18 Collaboration, Licensing and Other Arrangements HTML 429K 37: R19 Fair Value of Financial Instruments HTML 129K 38: R20 Common and Preferred Stock HTML 52K 39: R21 Earnings Per Common Share ("Eps") HTML 112K 40: R22 Stock Award Plans HTML 198K 41: R23 Commitments and Contingencies HTML 176K 42: R24 Employee Benefit Plans HTML 43K 43: R25 Income Taxes HTML 304K 44: R26 Summary of Significant Accounting Policies HTML 244K (Policies) 45: R27 Summary of Significant Accounting Policies HTML 98K (Tables) 46: R28 Acquisitions (Tables) HTML 114K 47: R29 Investments (Tables) HTML 154K 48: R30 Accounts Receivable (Tables) HTML 101K 49: R31 Inventories (Tables) HTML 57K 50: R32 Property and Equipment (Tables) HTML 99K 51: R33 Goodwill and Other Intangible Asset (Tables) HTML 53K 52: R34 Accrued Expenses and Other Current Liabilities HTML 106K (Tables) 53: R35 Borrowings (Tables) HTML 123K 54: R36 Collaboration, Licensing and Other Arrangements HTML 323K (Tables) 55: R37 Fair Value of Financial Instruments (Tables) HTML 122K 56: R38 Earnings Per Common Share ("Eps") (Tables) HTML 113K 57: R39 Stock Award Plans (Tables) HTML 193K 58: R40 Commitments and Contingencies (Tables) HTML 166K 59: R41 Income Taxes (Tables) HTML 303K 60: R42 Description of Business - 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Exhibit 10.49
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.
SECOND AMENDMENT
TO
COMMERCIAL SUPPLY AGREEMENT
This amendment is effective the last date signed by a party, between MannKind Corporation, a Delaware corporation (“MannKind”), having a principal place of business at One Casper Street, Danbury, Connecticut 06810, and United Therapeutics Corporation, a Delaware public benefit corporation (“United Therapeutics”), having a principal place of business at 1040 Spring Street, Silver Spring, Maryland 20910.
WHEREAS, the parties to this amendment entered into a Commercial Supply Agreement effective as of August 12, 2021 (as amended on October 16, 2021, the “Agreement”), and the parties now wish to amend the Agreement as set forth below.
NOW, THEREFORE, in consideration of the terms and conditions specified herein and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereby agree as follows:
|
1. |
AMENDMENT. |
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a. |
Section 1.2 (Annual Budget) is deleted and replaced with the following: |
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1.2 |
“Annual Budget” means an annual budget for all amounts to be invoiced to United Therapeutics pursuant to this Agreement in respect of a calendar year, in a format reasonably agreed to by United Therapeutics and MannKind, and at a minimum providing a breakdown of costs by Price, Staffing Payments, Facility Utilization Fees, and Packaging Services, and other discrete categories and subcategories as reasonably requested by United Therapeutics. |
|
b. |
The second sentence of Section 1.11 (Cost of Goods), set forth below as follows, is deleted: |
In addition, COGs will include an annual facility utilization expense (or rent) of $[***] (increasing to $[***] on December 1, 2021 and thereafter) per square foot for the portion of the Facility allocated to activities under this Agreement; provided, however, that such facility utilization expense shall not be subject to the Margin.
Page 1 of 7
Confidential
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.
|
c. |
The following defined term is added to the Agreement as new Section 1.14A: |
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1.14A |
“Facility Utilization Fee” means an amount equal to $[***]per month during the Term to compensate MannKind for the portion of the Facility used for Manufacturing and other activities covered by this Agreement, as has been reasonably determined by United Therapeutics and MannKind as of June 15, 2022, with the understanding that such amount will be reasonably adjusted by mutual agreement memorialized in an amendment to this Agreement or a letter agreement referencing this Agreement if and when there is a significant change to the amount of Facility space dedicated to Manufacturing and other activities covered by this Agreement. |
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d. |
Section 2.4.1 of the Agreement (“Rolling Forecast”) is deleted in its entirety and replaced with the following: |
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2.4.1 |
The “Rolling Forecast” is defined as the 18-month Manufacturing forecast for Product and Semi-finished Product submitted by United Therapeutics, as updated monthly within the first 10 business days of each month by United Therapeutics during the Term in accordance with Section 2.4.2, 2.4.3, and 2.4.4. The first six months of the Rolling Forecast shall be considered binding upon the parties (i.e., United Therapeutics shall place Purchase Orders for, and MannKind shall Supply, not less than the minimum quantity of Product and Semi-Finished Product specified in such Rolling Forecast during such period), and the remaining 12 months will be considered good faith estimates, but may be adjusted as necessary to meet United Therapeutics’ requirements, provided that notwithstanding the limited six-month binding portion of the Rolling Forecast, the Rolling Forecast in effect as of June 2, 2022 shall be considered binding through March 31, 2023. |
|
e. |
Section 3.2 of the Agreement (“Staffing Payments”) is deleted in its entirety and replaced with the following: |
Page 2 of 7
Confidential
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.
3.2. Staffing Payments and Facility Utilization Fee.
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3.2.1. |
Staffing Payments. United Therapeutics shall reimburse MannKind monthly for the Staffing Payment, subject to the limits set forth in Appendix E in 2022, and subject to the limits set forth in the Annual Budget in subsequent years during the effective Term, in each case upon receipt of an invoice in accordance with Section 3.3. United Therapeutics and MannKind agree to reasonably account for Staffing Payments in calendar year 2023 and beyond through the Annual Budget process, and further agree that the per-item Prices shall exclude the components of COGs that are being invoiced in such Staffing Payments. |
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3.2.2 |
Facility Utilization Fee. Effective as of May 1, 2022, United Therapeutics shall be responsible for the monthly Facility Utilization Fee upon receipt of an invoice in accordance with Section 3.3, such invoice specifying the fee owed as specified in section 1.14A. MannKind shall ensure that no depreciation for the building, United Therapeutics funded capital, or other overhead is separately charged to United Therapeutics, or forms the basis of any Product or Semi-Finished Product Price, by virtue of the definitions of “COGs” or “Fixed Overhead”, for the portion of the Facility that gives rise to the Facility Utilization Fee. |
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f. |
Section 3.3.1 of the Agreement is deleted and replaced with the following: |
On the fifth business day of each month, MannKind shall invoice United Therapeutics for any Staffing Payment owed pursuant to section 3.2.1 and any Facility Utilization Fee owed pursuant to section 3.2.2, in each case in respect of the immediately preceding calendar month.
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2. |
GENERAL. All terms of the Agreement that are not specifically modified by this amendment remain in full force and effect. The parties may execute this amendment in counterparts, each of which is deemed an original for all purposes, and which together will constitute the same instrument. The parties may execute this amendment by electronic means (electronic signature through generally recognized e-signature vendors), by scanned pdfs of wet-ink signed documents, or by return of originals. |
* * *
Signature page follows
Page 3 of 7
Confidential
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.
IN WITNESS WHEREOF, the parties have caused this amendment to be signed by their duly authorized representatives as of the date indicated below.
United Therapeutics Corporation
By: /s/ Patrick Poisson Name: Patrick Poisson Title: EVP, Technical Operations Date: 15-June-2022 |
MannKind Corporation
By: /s/ Joe Kocinsky Name: Joe Kocinsky Title: Chief Technology Officer Date: 15-June-2022 |
Page 4 of 7
Confidential
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.
APPENDIX B
PRICE AND PRICE ADJUSTMENTS
[***]
Page 5 of 7
Confidential
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.
APPENDIX E
STAFFING PAYMENTS
[***]
Page 6 of 7
Confidential
This ‘10-K’ Filing | Date | Other Filings | ||
---|---|---|---|---|
3/31/23 | ||||
Filed on: | 2/23/23 | 8-K | ||
For Period end: | 12/31/22 | |||
6/15/22 | ||||
6/2/22 | ||||
5/1/22 | ||||
12/1/21 | ||||
10/16/21 | 8-K | |||
8/12/21 | 8-K/A | |||
List all Filings |
As Of Filer Filing For·On·As Docs:Size Issuer Filing Agent 2/27/24 Mannkind Corp. 10-K 12/31/23 123:18M Donnelley … Solutions/FA 8/23/23 Mannkind Corp. S-8 8/23/23 6:252K Donnelley … Solutions/FA |