FIRST AMENDMENT OF AMENDED AND RESTATED MANUFACTURING AND SERVICES AGREEMENT
Exhibit 10.33
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
FIRST AMENDMENT OF AMENDED AND RESTATED MANUFACTURING AND SERVICES AGREEMENT
THIS FIRST AMENDMENT OF AMENDED AND RESTATED MANUFACTURING AND SERVICES AGREEMENT (the “Amendment”) is made as of February 18, 2019 (the “Effective Date”) by and between Paratek Pharmaceuticals, Inc., a corporation existing under the laws of Delaware, with an address at 00 Xxxx Xxxxx, 0xx Xxxxx, Xxxxxx, XX 00000 (“Paratek”) and CIPAN ̵̶ Companhia Industrial Produtora de Antibióticos, S.A., a corporation organized and existing under the laws of Portugal with an address at Xxx xx Xxxxxxx, xx00, 0000-000 Xxxxxxxxxxx do Ribatejo, Portugal (“CIPAN”, collectively referred to herein with Paratek as the “Parties” and each, a “Party”). Capitalized terms used, but not otherwise defined, herein shall have the meanings set forth in the Agreement.
WHEREAS, Paratek and CIPAN are parties to that certain Manufacturing and Services Agreement, dated November 2, 2016 (as amended on October 18, 2017, the “Original Agreement”) and that Original Agreement was subsequently amended and restated by the Parties on April 18, 2018 (the “Agreement”);
WHEREAS, Pursuant to the Agreement, (a) CIPAN is obligated to manufacture Minocycline HCI dihydrate meeting the Specifications (“Minocycline”) and crude Omadacycline meeting the Specifications (“Crude Omadacycline” and, collectively with Minocycline, the “Products”, and each, a “Product”) for Paratek and (b) in exchange for technology and financial assistance from Paratek to CIPAN;
WHEREAS, the Parties now desire to amend the Agreement as set forth in this Amendment;
NOW THEREFORE, the Parties agree as follows:
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1. |
First Amendment to the Agreement. The Agreement is amended and modified as follows: |
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a. |
Section 7.1 is hereby amended and restated to read in its entirety as follows: |
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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such item’s delivery to Paratek or its designee hereunder. Time is of the essence for all deliveries of Products. CIPAN shall ensure that all Product held in storage is stored in accordance with the Specifications until delivery to Paratek under this Agreement and that all storage areas meet cGMP requirements. In the event of any delay in delivery of Product from the delivery date on the applicable purchase order for such Product, if such delay is: [***], unless, in each case ((a) and (b)), such delay is due to a Force Majeure Event causing a worldwide shortage of the applicable Materials, in which case Article 17 shall apply. |
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b. |
The following new Section 7.2 shall be added, and the numbering of the subsequent sections of Agreement shall be updated accordingly: |
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i. |
Minocycline. CIPAN shall ensure that all Minocycline held in storage is stored in accordance with the Specifications until such Minocycline is manufactured into Crude Omadacycline and delivered to Paratek or its designee and that all storage areas meet cGMP requirements. For the avoidance of doubt, Paratek shall not hold title to or bear any risk of loss or damage to any Minocycline prior to such Minocycline being manufactured into Crude Omadacycline and such Crude Omadacycline being delivered to Paratek in accordance with Section 7.1 (or, if such Minocycline is not to be manufactured into Crude Omadacycline under this Agreement, prior to delivery to Paratek of such Minocycline in accordance with Section 7.1). |
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c. |
Section 8.1 is hereby amended and restated to read in its entirety as follows: |
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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e. |
Exhibit A to the Agreement is hereby deleted in its entirety and replaced with Exhibit A attached to this Amendment. |
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
IN WITNESS WHEREOF, the duly authorized representatives of the Parties have executed this Amendment as of the Effective Date.
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By: |
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/s/ Xxxxx Xxxxxxxx |
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Name: |
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Xxxxx Xxxxxxxx |
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Title: |
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Sr. Vice President of Technical Operations |
CIPAN Companhia Industrial Produtora de AntibiÓticos, S.A.
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By: |
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/s/ Xxxxxx Xxxxx |
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Name: |
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Xxxxxx Xxxxx |
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Title: |
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CEO |
[Signature Page to Amendment]
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
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