Amendment No. 2 to the Manufacture and Supply Agreement, dated December 13, 2023 entered into by and between Savara ApS GEMABIOTECH SAU
Exhibit 10.36
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. 2 TO
MANUFACTURE AND SUPPLY AGREEMENT
This Amendment No. 2 to the Manufacture and Supply Agreement (“Amendment No. 2”), dated December 13, 2023 (“Effective Date”), is entered into by and between Savara ApS, a Denmark private limited company having registered offices at c/o Lundgrens Advokatpartnerselskab, Tuborg Boulevard 12, 2900 Hellerup, Denmark (“Savara”) and GEMABIOTECH SAU, a corporation organized under the laws of Argentina, having registered offices at Fray Justo Sarmiento 2350 Edificio 2B Piso 5, Olivos, Province of Buenos Aires, Argentina (“GEMA”) (each referred herein by name, or individually, as a “Party” or collectively, as the “Parties”).
WHEREAS, Savara and GEMA entered into a Master Services Agreement dated April 26, 2019 (the “Agreement”) providing for Savara to engage GEMA to manufacture the API (as defined in the Agreement) and GEMA to achieve commercial compliance and manufacture and supply the API, which was subsequently amended by Amendment No. 1 dated December 7, 2022; 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:
4.8 Purchase Requirement. For 10 years following the date of receipt of approval by a Regulatory Authority of the first Regulatory Filing for the marketing and sale of the first Product in any country, Savara will purchase from GEMA the API required for [***]% of such Product offered for sale (the “Purchase Requirement”); provided, however, the Purchase Requirement will no longer apply if (i) the price charged by GEMA is greater than [***]% more than the price charged by an alternative supplier, (ii) there is a Shortage of Supply, or (iii) GEMA at any time fails to fulfill a Purchase Order.
Savara ApS
c/o Savara Inc.
1717 Langhorne Newtown Rd.
Suite 300
Langhorne, PA 19047
Email: ***@***
Attention: Chief Financial & Administrative Officer
Exhibit 10.36
Exhibit 10.36
IN WITNESS WHEREOF, the parties have caused this Amendment No. 2 to the Agreement to be executed on the Effective Date set forth above.
Savara ApS GEMABIOTECH SAU
By: _/s/ David Lowrance____________ By: __/s/ Juan Ceriani_____________
Name: __David Lowrance ___________ Name: ___ Juan Ceriani____________
Title: Chief Financial & Administrative Officer Title: ____General Manager_________
Date: __December 18, 2023__________ Date: ____ December 19, 2023_______
Exhibit 10.36
Exhibit 6.1
Pricing and Milestone Schedule
Purchase Price of API:
Prior to Market Authorization: $[***] per gram of Molgramostim API
Following Market Authorization: $[***] per gram of Molgramostim API
Milestone Payments
Milestone Event | Activities | Milestone Payment | |
(in USD) | |||
1 | Effective date of the Agreement | Batch N°18-GMCF-031-010 Release | |
Completed/Paid | Batch N°18-GMCF-031-010 Samples Characterization | $[***] | |
Protocol for Upstream Characterization | |||
Upstream Characterization Final Report | |||
2 | Validations stage 1 completion | Protocol for Downstream Characterization | |
Completed/Paid | Downstream Characterization Final Report | $[***] | |
New Analytical Methods Development Report | |||
New Analytical Methods Development SOPs | |||
3 | Validations of analytical method completion | Validation or Revalidation of IPC Protocol | |
Completed/Paid | Validation or Revalidation of IPC Final Report | ||
Validation or Revalidation of Analytical Techniques for DS Protocols | |||
Validation or Revalidation of Analytical Techniques for DS Final Report | $[***] | ||
Reference standard, manufacturing and testing protocol | |||
Reference standard, manufacturing and report | |||
4 | Validations stage 2 completion | Stability study protocol | |
Stability study start-up | |||
Protocols for Validation GMP batch | |||
Completed/Paid | Validation of GMP batch (including 3 batches –up to120 gr) CoA | ||
Validation of GMP batch Final Report | $[***] |
Exhibit 10.36
Activities related to preparation for technology transfer | |||
5 | Batch fermentation ($473,000) | ||
Completed/Paid | Execution of Amendment No. 1 | Preparation for FDA Audit ($300,000) | $[***] |
Facility improvements for GMP compliance ($250,000) | |||
6 Expected [***] | Single Use | Readiness to initiate updating Quality and Production documentation from the actual manufacturing systems to Single Use format Readiness to initiate Engineering Batch with Single Use Containers | $[***] $[***] |
7 Expected [***] | Validation Approvals | Completion of cleaning and sterilization validation | $[***] |
8 Expected [***] Expected [***] | Batches | Completion of three successful fermentation batches Completion of three successful purification batches | $[***] $[***] |
9 Expected [***] | Mock PAI | Successful JYA Mock PAI with no more than three critical findings, which are then resolved | $[***] |
10 Expected [***] | Marketing Authorization | Includes approval of GEMA as a production site for molgramostim | $[***] |
Total Potential Milestone Payments | $[***] |