AMENDMENT No. 1 TO MANUFACTURE AND SUPPLY AGREEMENT
Exhibit 10.33
Certain identified information in this document has been excluded because it is both (i) not material and (ii) would likely cause competitive harm if publicly disclosed. [***] indicates where such information has been omitted.
AMENDMENT No. 1 TO MANUFACTURE AND SUPPLY AGREEMENT
This Amendment No. 1 to the Manufacture and Supply Agreement (“Amendment No. 1”), dated December 7, 2022 (“Effective Date”), is entered into by and between Savara ApS, a Denmark private limited company having a principal place of business at c/o Lundgrens Advokatpartnerselskab, Xxxxxx Xxxxxxxxx 00, 0000 Xxxxxxxx, Xxxxxxx (“Savara”) and GEMABIOTECH SAU, a corporation organized under the laws of Argentina, having a principal place of business at Xxxxxxx xxx Xxxxxxxxxx 0000, Xxxxxx, Xxxxxxxx xx Xxxxxx Xxxxx, Xxxxxxxxx (“XXXX”) (each referred herein by name, or individually, as a “Party” or collectively, as the “Parties”).
WHEREAS, Xxxxxx and XXXX entered into a Master Services Agreement dated April 26, 2019 (the “Agreement”) providing for Savara to engage XXXX to manufacture the API (as defined in the Agreement) and XXXX to achieve commercial compliance and manufacture and supply the API; and
WHEREAS, the parties now wish to amend the Agreement to modify certain terms of the Agreement.
NOW THEREFORE, in consideration of the recitals set forth above, the mutual covenants, terms and conditions set forth below, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
IN WITNESS WHEREOF, the parties have caused this Amendment No. 1 to the Agreement to be executed on the Effective Date set forth above.
Savara ApS |
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GEMABIOTECH SAU |
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By: |
/s/ Xxxx Xxxxxxxx |
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By: |
/s/ Xxxx Xxxxxxx |
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Name: |
Xxxx Xxxxxxxx |
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Name: |
Xxxx Xxxxxxx |
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Title: |
CFO |
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Title: |
General Manager |
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Date: |
12/7/2022 |
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Date: |
12/7/22 |
Exhibit Error! Reference source not found.
Pricing and Milestone Schedule
Purchase Price of API:
Prior to Market Authorization: $[***] per gram of Molgramostim API (Currently being review by the Parties)
Following Market Authorization: $[***] per gram of Molgramostim API (Currently being review by the Parties)
Milestone Payments
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Milestone Event |
Activities |
Milestone Payment (in USD) |
1 Completed/Paid |
Effective date of the Agreement |
Batch N°18-GMCF-031-010 Release Batch N°18-GMCF-031-010 Samples Characterization |
$[***] |
2
Completed/Paid |
Validations stage 1 completion |
Protocol for Upstream Characterization Upstream Characterization Final Report Protocol for Downstream Characterization Downstream Characterization Final Report |
$[***] |
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New Analytical Methods Development Report |
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New Analytical Methods Development SOPs |
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3 |
Validations of analytical method completion |
Validation or Revalidation of IPC Protocol |
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Completed/Paid |
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Validation or Revalidation of IPC Final Report |
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Validation or Revalidation of Analytical Techniques for DS Protocols |
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Validation or Revalidation of Analytical Techniques for DS Final Report |
$[***] |
4 |
Validations stage 2 completion |
Reference standard, manufacturing and testing protocol Reference standard, manufacturing and report Stability study protocol Stability study start-up |
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Completed/Paid |
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Protocols for Validation GMP batch Validation of GMP batch (including 3 batches –up to120 gr) CoA Validation of GMP batch Final Report |
$[***] |
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Activities related to preparation for technology transfer and |
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5 |
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Batch fermentation [$***] |
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Expected Q4 2022 |
Execution of Amendment No. 1 |
Preparation for FDA Audit [$***] |
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Facility improvements for GMP compliance [$***] |
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$[***] |
6 Expected [***] |
Approval of FDA Audit |
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$[***] |
7 Expected [***] |
Marketing Authorization |
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$[***] |
Total Potential Milestone Payments |
$[***] |
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