Exhibit 10.32
[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
EXHIBIT A
Scope of Work (SOW)
Scope of Work
P-10558-01 Extension A
Scope of Work for Cleanroom 3 Use
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(April 1st, 2023 to December 31st 2023
With Options through Q4 2024)
2
Section 1 - Background/Scope
Azzur Cleanrooms On Demand (“COD”) facilities are designed for clients to utilize controlled clean areas and services related to early phase cGMP manufacturing. This Scope of Work (“SOW”) is for 9 months, subject to terms and conditions specified in the LICENSE AND SERVICES AGREEMENT, of cleanroom use (“CR3”) and support related services at the COD facility located at 411 Waverley Oaks Rd., #126, Waltham, MA 02452. This SOW is an Extension to P-10558-01 for the duration of April 2023 to December 2023. This SOW is entered into by and COD (“Licensor”) and Synlogic (“Licensee”) effective as of the approval date of this SOW. Upon execution of this SOW, this SOW will be incorporated into the mutually approved License and Services Agreement (“LSA”) that contains additional terms and conditions of the COD Cleanrooms and support services use.
Section 2 – License and Technical Requirements
Commencing on the Effective Date and subject to the terms and conditions of the LSA, Licensor grants to Licensee a license to access and use the cleanroom with specification described in Section 3. Licensor will provide the support services described in this Section 3 using Licensor personnel. Licensor personnel will perform the services in a timely, professional and workmanlike manner and in accordance with all applicable laws, regulations and guidelines. Licensor will maintain all permits, licenses or other approvals necessary for the operation of the Cleanroom in accordance with the requirements set forth herein. Specifically, Licensor will perform Services in accordance with the following:
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Licensee personnel using the classified areas are to be trained on Licensor SOPs on gowning, personnel movement, material control, gowning training, safety training etc.
Section 3 – Detailed Scope
This SOW provides details of the licensed cleanroom space, office space, support services and the related inclusions.
Dedicated CR3 cleanroom space for a duration of 9 months with a start date of April 2023, with the automatic option by Licensee to extend through the end of Q2 2024. (June 30, 2024) (the “First Option”). Licensee shall notify Azzur by October 1, 2023 if it seeks to exercise the First Option. If Licensee exercises the First Option, Licensee shall then have the automatic option to extend through the end of Q4 2024 (December 31, 2024) on the same 2024 monthly cost terms as set forth below. Licensee shall notify Azzur by April 1, 2024 if it seeks to exercise the Second Option.
Remote alarm management is performed by Licensor.
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NOTE: BSC cleaning and disinfection during routine use is Licensee’s responsibility.
NOTE: Changes in cleaning regimen including type of agents and frequency as well as enhanced cleaning for changeover can be implemented, the costs for which are not included in this SOW.
NOTE: Changes in environmental monitoring including additional in-process monitoring costs are included in Table 4 of this SOW.
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Section 4 – Fees
The License Fee will be pre-paid on a monthly basis and includes items listed under the relevant category in Table 1 below. A monthly Variable Budget for support services overage compared to SMU amounts and out of scope activities has been established at $[***]per month. Specifically, the variable budget will cover the following known items, as needed:
Table 1 below shows the costs related to support services for monthly overages and other services to be covered by the Variable Budget, if required. 2023 Monthly Costs have stayed as proposed previously, while 2024 Monthly Costs have been added as an option and include the [***]% annual rate adjustment to account for increased facility maintenance and personnel costs etc. Note that the unit costs of overages are higher than unit costs included in the License Fees as unplanned activities result in additional costs such as offsite storage, material movement and personnel time.
Table 1: 2023 Monthly Costs and 2024 Monthly Costs (Extension Options) | |||
Item Description | # of Units/ month | 2023 Monthly Costs | 2024 Monthly Costs |
[***] | [***] | [***] | [***] |
[***] | [***] | [***] | [***] |
[***] | [***] | [***] | [***] |
[***] | [***] | [***] | [***] |
[***] | [***] | [***] | [***] |
Personnel Support | [***] | [***] | [***] |
Material Management Warehouse Movement | [***] | [***] | [***] |
Consumables | [***] | [***] | [***] |
Waste Surcharge | [***] |
| [***] |
Monthly Totals | [***] | [***] | |
Variable Budget
| [***] | [***] |
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Table 2: Overage/Other Costs | |
Type | Unit Cost |
[***] | [***] |
[***] | [***] |
[***] | [***] |
[***] | [***] |
Materials Management Warehouse Movement | [***] |
3rd party costs | [***] |
Personnel Support | [***] |
Enhanced EM* | [***] |
Personnel Training | [***] |
Non – Standard Business Hour Support | [***] |
Section 5 – Payments and Invoicing
All invoices are due net +30 days from the invoice date. Fixed amounts for the monthly License Fee will be generated at the start of each month. Monthly invoices for variable amounts will be generated out at the end of each month, if required based on actual usage.
The total amount for cleanroom use and related services for 9 months starting April 2023 to December 2023 is $1,707,074. In addition, the variable budget of $[***]/month, total amount $[***] will also be required. A Purchase Order (“PO”) for the total amount is required for the reservation of the cleanroom and related services specified in this SOW.
Section 6 – Approvals
SOW Generated by (COD):
Date: 22 Nov 2022
Name: /s/ Daniel Dernbach
Email: daniel.dernbach@azzur.com
SOW Accepted by (Synlogic):
DATE: 11/22/2022
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NAME: Michael Jensen, CFO /s/ Michael Jensen
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