Exhibit
10.15


 





 


PROJECT
ADDENDUM II TO MASTER SERVICES AGREEMENT


 


This
Project Addendum is effectively dated as of May 21, 2021 (the “Effective Date”) by and between Blue Water Vaccines, Inc.,
a Delaware corporation having a principal place of business at 15 East Putnam Avenue, Suite 363, Greenwich, CT 06830 (“Blue Water”
or “Client”), and Ology Bioservices, Inc., a Delaware corporation having a principal place of business at 13200 NW Nano Court,
Alachua, Florida 32615 (“Ology Bio”). Blue Water and Ology Bio are sometimes referred to herein individually as a “Party”
and collectively as the “Parties.”


 


WHEREAS,
Blue Water and Ology Bio entered into a Master Services Agreement effectively dated as of July 19, 2019, (the “MSA”) whereby
Ology Bio agreed to provide from time to time services and deliverables associated therewith (“Services”) to Client pursuant
to the terms and conditions set forth in the MSA and any Project Addendum;


 


WHEREAS,
Blue Water and Ology Bio desire to enter into this Project Addendum II for Services as set forth herein, subject to and in accordance
with the MSA.


 


NOW,
THEREFORE, in consideration of the foregoing and the mutual promises, covenants and agreements set forth below, and for other good and
valuable consideration, the receipt and sufficiency of which the parties hereby acknowledge, the parties agree as follows:


 


1. SCOPE
OF WORK


 


To
achieve the client’s goal of process development and CGMP manufacturing of the live attenuated Streptococcus pneumoniae
vaccine program, Blue Water requires the services of a CDMO. Ology Bio’s experienced team of Subject Matter Experts and qualified
subcontractors will comply with all applicable regulatory requirements to accomplish the scope of work. This proposal consists of eight
tasks required for to complete the project, including:


 


Task
1: Technology Transfer and Process Establishment


Task
2: Analytical Assay Development


Task
3: CGMP Master Cell and Working Cell Banks


Task
4: Process Scale-Up and Optimization


Task
5: Engineering Drug Substance Run and Stability Testing


Task
6: CGMP Drug Substance Run and Stability Testing


Task
7: Engineering and CGMP Drug Product


Task
8: OPTIONAL: Preclinical IND-Enabling Studies


 




     


     

    

 





	Manufacturing of Streptococcus pneumoniae Vaccine Candidate	May 21, 2020 


 


2. STATEMENT OF WORK


 


Task 1: Technology Transfer and Process Establishment


 


Technical Assumptions:

 





		●	Product-specific
                                            information (e.g., Bill of Materials (BOM), previous run data, intermediate stability data,
                                            any regulatory documentation, test methods) will be transferred within 15 business days of
                                            contract signing.





		●	The kick-off
                                            meeting will be scheduled within 15 business days of contract signing.



		●	Two
                                            Process Establishment Runs will be performed in this task using the established methodology
                                            provided by Blue Water.



		●	Blue
                                            Water will provide a culture and Ology Bio will generate a Research Cell Bank (RCB), reagents
                                            and standards and associated Certificates of Analysis (COAs), as required, to Ology Bio within
                                            15 days of contract signing.



 


Information
Transfer and Gap Assessment:


 


The
Information Transfer stage is critical for the success and timeliness of the project. We request that all pertinent documents from Blue
Water will be supplied within 15 days of contract signing to allow enough time for critical review by our team. A kick-off meeting will
be scheduled with review of the plans and timelines. After the project gap analysis is complete, a final schedule and Gantt chart will
be completed.


 


Receiving
Blue Water Documentation:


 


To
initiate the technology transfer, we will conduct a thorough review of all process and analytical documents provided by Blue Water. In
collaboration with Blue Water, we will create a Development Plan for the development of the live attenuated Streptococcus pneumoniae
vaccine candidate. Blue Water will provide Ology Bio with all applicable standard operating procedures (SOPs), process procedures,
process transfer protocols, analytical plans, specifications and other knowledge to transfer analytical methods and the manufacturing
process. Technology transfer will include the following preparation activities:


 


		●	Preparation
                                            of a Development Plan



		●	Preparation
                                            of documentation





		●	Equipment
                                            Identification



		●	Flow diagrams
                                            as appropriate



		●	Process
                                            step descriptions





		●	Risk Analysis
                                            and Mitigation Strategy



 


Transfer
of Product-Specific Materials from Blue Water and Procurement of Materials and Components:


 


Blue
Water will provide cultures, reagents and standards, and associated COAs, as required, to Ology Bio within 15 days of contract signing
in order to stay within the aggressive timeline for this program.


 


A
full list of raw materials will be developed and sent to Blue Water for approval. All consumables, expendables and raw materials will
be purchased using QA-approved vendors, properly inventoried and stored in the proper conditions. We may elect to purchase pre-prepared
media and certain buffers from agreed-upon suppliers to avoid any variability in these critical reagents in the process. We will identify
and qualify suppliers of production materials and any required excipients. The nature of this project will require that additional materials
identified in the Process Development Task to be communicated to Blue Water at a later date.


 


Development
Plan and Reports:


 


Weekly
or biweekly presentations will be provided to Blue Water that summarizes the performance of the process per plan. At the end of Task
1, a draft Development Plan will be written and reviewed/approved by both Ology Bio and Blue Water. The Development Reports will be written
after execution of Establishment Runs to contain details on each unit operation; trending of the data compared with any available historical
data (i.e., provided in Blue Water documents);analytical testing results; process deviations and impact assessment; our proposed process
changes, including assessment of impact and justifications for changes; and updated risk and gap assessment.


 





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	Manufacturing of
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Process
Establishment:


 


We
will generate a Research Cell Bank based on the cultures provided by Blue Water (Task 4). We will perform two Process Establishment Runs
to demonstrate the process for the Blue Water Streptococcus pneumoniae vaccine candidate at laboratory scale (1 L shake flask)
and prepare a Process Transfer Final Report for approval by Blue Water. Limited testing will be performed on these Establishment Runs
(cell viability and culture purity). We will also present a preliminary BOM at the end of this task.


 


Task 1
Deliverables:


 


		●	Final Schedule
                                            Agreement with Blue Water and Ology Bio at completion of this task.





		●	Project
                                            Management Plan including Project Charter



		●	Meeting
                                            agenda and minutes





		●	Draft Process
                                            Development Plan



		●	Process
                                            Establishment Plan and Report



		●	Preliminary
                                            BOM



 


Task
2: Analytical Assay Development


 


Technical
Assumptions:


 


		●	Blue
                                            Water will provide analytical Reference Standards, product-specific reagents, and initial
                                            samples of Drug Substance (DS) for use in method transfer and validation.



		●	All required
                                            analytical methods are summarized in Tables 1 and 2.





		●	Assay qualification
                                            will be phase appropriate.



 


A
complete list of analytical assays will be provided by Blue Water or agreed upon with Ology Bio. Specifications for each of the assays
will also be provided by Blue Water or agreed upon with Ology Bio. We propose to perform Technology Transfer feasibility assessments
on the QC assays outlined in Tables 1 and 2 for DS and DP testing. Following the Technology Transfer feasibility assessment, QC
scientists will revise method SOPs (as required) and verify methods for testing. Upon completion of the verification studies, a comprehensive
report, reviewed and approved by QA, will be provided documenting the results of the verification, the suitability of the intended method,
a description of test samples, a description of experiments and a summary of data for each parameter tested, as well as relevant raw
data obtained from these studies. These assays will also be qualified as suitable for CGMP release and use in Phase 1 clinical trials.
Testing will not be outsourced without the prior written consent of Blue Water.


 


Table
1. Analytical Release Testing for Streptococcus pneumoniae Drug Substance


 


	Release Tests	 	Company/Test
	Strain ID	 	CRL GP-V928 Microbial ID by DNA Sequencing Accugenix
    System
	Strain Purity (by differential media)	 	CRL GP-V715 Determination of Purity Using Different
    Agars
	Viability (CFU/ml)	 	CRL GP-V732 Titer Determination of Microbial Suspensions
	Growth Stability (bacterial doubling time)	 	Ology Bio
	Endotoxin (LAL)	 	Ology Bio


 





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	Manufacturing of
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Table
2. Analytical Release/Characterization Testing for Streptococcus pneumoniae DS/DP


 


	Characterization Assay	 	Company/Test
	Strain ID	 	CRL GP-V928 Microbial ID by DNA Sequencing Accugenix
    System
	Strain Purity (by differential media)	 	CRL GP-V715 Determination of Purity Using Different
    Agars
	Viability (CFU/ml)	 	CRL GP-V732 Titer Determination of Microbial Suspensions
	Western Blot for CbpA and PspA	 	Outsourced (company TBD)
	Appearance	 	Ology Bio
	Growth Stability	 	Ology Bio
	Endotoxin (LAL)	 	Ology Bio


 


Task 2
Deliverables:


 


		●	Analytical
                                            assay Qualification Plan



		●	QA-reviewed
                                            and approved Qualification Report for each analytical method





		●	In-process
                                            and release assay specifications



 


Task
3: CGMP Master and Working Cell Banks


 


Technical
Assumptions:


 


		●	A minimum
                                            of 300 CGMP MCB vials will be prepared.



		●	A minimum
                                            of 300 CGMP WCB vials will be prepared.





		●	RCB required
                                            for MCB production will be generated at Ology Bio in Task 4.



 


In
compliance with CGMP Regulations, we will produce a minimum of 300 vials of a Master Cell Bank (MCB) for the vaccine candidate per QA-approved
batch production records using the materials originally supplied by Blue Water and the RCBs generated by Ology Bio as part of Task 4.
These RCBs will be utilized for the production of the CGMP MCBs. The new MCBs will undergo characterization and release testing based
on an analytical control strategy outlined in Table 3. We propose to generate CGMP Working Cell Banks (WCBs) from the MCBs and
characterize them.


 


Table
3. Cell Bank Release Assays


 


	Cell Bank Release Assay	 	Company/Test
	 	 	 
	Strain ID	 	CRL GP-V928 Microbial ID by DNA Sequencing Accugenix
    System
	Strain Purity (by differential media)	 	CRL GP-V715 Determination of Purity Using Different
    Agars
	Viability (CFU/ml)	 	CRL GP-V732 Titer Determination of Microbial Suspensions
	Growth Stability	 	Ology Bio
	Bacteriophage	 	Outsourced (company TBD)
	Whole genome sequencing	 	Outsourced (company TBD)
	Western Blot for antigen production	 	Outsourced (company TBD)
	Agglutination assay for capsule production	 	Outsourced (company TBD)


 





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	Manufacturing of
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An annual
stability program will also be initiated and will be continued for up to three years for both MCB and WCB. For budgeting purposes, testing
will only be conducted for 12 months, but cells will remain on stability for future testing. The stability testing is provided in Table
4.


 


Table
4. Cell Bank Stability Assays


 


	Cell Bank Stability Assays	 	Company/Test
	Growth Stability	 	Ology Bio
	Viability (CFU/ml)	 	CRL GP-V732 Titer Determination of Microbial Suspensions
	Cell culture purity	 	CRL GP-V715 Determination of Purity Using Different Agars
	Western Blot for Antigen Production	 	Outsourced (company TBD)
	Agglutination Assay for Capsule Production	 	Outsourced (company TBD)





 


Task 3
Deliverables:


 


		●	Summary
                                            Report on cell banking and release for both MCB and WCB for the Streptococcus pneumoniae
                                            candidates including COAs and copies of Master Batch Records



		●	Cell bank
                                            stability plan for the candidate MCB and WCB for review and approval by Blue Water



		●	A minimum
                                            of 300 CGMP MCB vials





		●	A minimum
                                            of 300 CGMP WCB vials



 


Task
4: Process Scale-Up and Optimization


 


Technical
Assumptions:


 


		●	The Process
                                            Development Plan outlining the experimental plan will be approved by Blue Water.





		●	Successful
                                            Process Establishment Runs were completed in Task 1.



		●	Process
                                            Development will include generation of RCBs.





		●	Two process
                                            development runs at the 3 L scale will be performed.



		●	Two scale-up
                                            runs at the 120 L scale will be performed.



 


We
will initially generate RCBs from the materials provided by Blue Water. We will identify three individual colonies, and each of the colonies
will be grown at the 1-3 mL scale and will be analyzed as described in Table 1. Two colonies will be scaled up and used to generate
50 vials of RCB. These RCBs will then be utilized for production of the CGMP MCBs and WCBs as described in Task 3. Each RCB will be characterized
as per Table 3.


 


These
RCBs will be used for the initial process development studies. The process development will focus on the upstream and downstream processing
of the vaccine candidates. Small-scale upstream production runs (1 L scale) will be used to generate materials for the downstream processing.
We propose to scale-up the manufacturing process to the 120 L scale. This will include two 3 L production runs to identify the optimum
upstream parameters for maximum production of the vaccine candidate. We then propose to perform two scale-up runs at the 120 L scale
using the 150 L fermenter, the proposed manufacturing production scale. These runs will be analyzed using the in-process and release
tests as described in Task 2. Success criteria for these runs will be agreed upon by Blue Water and Ology Bio prior to initiation of
these runs. The sampling plan for these runs will also be agreed upon prior to initiation of the runs. Draft batch records and a final
sampling plan will be prepared for use in the Engineering Runs (Task 5).


 





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	Manufacturing of
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Task 4
Deliverables:


 


		●	Process
                                            Development Report for Blue Water review and approval





		●	Materials
                                            from the Process Development Runs



		●	Process
                                            Scale-up Plan





		●	Process
                                            Scale-up final report for review and approval by Blue Water



		●	Materials
                                            from the Scale-up runs



		●	Process
                                            parameters for the Engineering Run





		●	Technology
                                            Transfer Protocol



		●	Draft
                                            batch records and sampling plan for use in the Engineering
                                            Run





		●	Confirmation
                                            Run report and materials



 


Task
5: Engineering Drug Substance Run and Stability Testing


 





Technical
Assumptions:


 


		●	We
                                            propose to perform one Engineering Run for the Streptococcus pneumoniae DS at the
                                            120 L scale.



		●	In-process
                                            and release testing will be performed as described in Task 3.





		●	Materials
                                            will be placed on 12-month stability.



		●	DS
                                            Reference Standard materials will be generated (1,000 vials).



 


We
will perform one Engineering Run at full scale of 120 L. The in-process and release testing plan for this run will be agreed upon by
Blue Water and Ology Bio. The Engineering Run will be executed at the 120 L production scale by manufacturing staff in a GMP-like environment
at the Facility. The Engineering Run will be performed using draft Master Batch Records and QA-released raw materials and components.
The batch records will be redlined during the Engineering Run, and any changes will be incorporated into the Master Batch Records prior
to approval for CGMP manufacturing. The in-process and release assays are described in Task 2, Table 2.


 


The
material generated from this lot will be indicative of the CGMP-manufactured material. The materials from this lot will be made available
to Blue Water for additional studies. In addition, materials from this lot will be used to generate Reference Standard materials. A COA
and Material Safety Data Sheet (MSDS) will be prepared at this stage. A completed BOM will be submitted as part of this Stage. The non-CGMP
DS material will be placed on stability studies.


 


Stability
Testing:


 


Stability
testing of non-CGMP Engineering DS will be conducted in accordance with current U.S. FDA Code of Federal Regulations (CFR) and International
Conference on Harmonization (ICH) guidelines, including:


 


		●	21
                                            CFR Parts 210 and 211 (CGMPs)





		●	21
                                            CFR Part 312 (IND Application)



		●	ICH
                                            Q1A (R2) Guideline: “Stability Testing of New Drug Substances and Products,”
                                            February 2003



		●	ICH
                                            Q1C Guideline: “Stability Testing of New Dosage Forms," November 1996





		●	ICH
                                            Q5C Guideline: “Stability Testing of Biotechnological/Biological Products,” November
                                            1995



 


The
stability evaluation will support the following:


 


		●	Use
                                            of the investigational product throughout nonclinical studies and clinical trials



		●	Mitigation
                                            of shipping and storage temperature excursion impact on the investigational product






		●	Stability
                                            of the product during handling (clinical sites, emergency-use scenarios)



		●	Selection
                                            of lot release and stability-indicating analytical test methods






		●	Expiration
                                            or retest dates for DS



		●	Product
                                            conformity to stability specifications throughout the clinical trial



 


The
proposed stability study for non-CGMP (as well as CGMP) DS lots is provided in Table 5. Stability testing will be conducted per
approved protocols and reported annually.


 





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	Manufacturing of
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Table
5. Drug Substance and Drug Product Stability


 


	Test 	 	Location 	 	Acceptance Criteria 	 	 	0m*		 	 	1m		 	 	3m		 	 	6m		 	 	9m		 	 	12m		 	 	18m		 	 	24m	
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Viability 	 	CRL 	 	TBD 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X  	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Strain ID 	 	CRL 	 	TBD 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Growth stability 	 	Ology Bio 	 	TBD 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X	 	 	 	X  	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Sterility	 	Ology Bio	 	No fungal or undesired

 bacterial growth observed	 	 	X	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	X	 	 	 	 	 	 	 		 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Genetic stability  (PCR and Western)	 	TBD	 	Presence of PCR product

                                                                         and antigen
	 	 	X	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	X	 	 	 	 	 	 	 	X	 




 


		*	Release Testing



 


Reference
Standard:


 


Providing
high-quality, documented and qualified Reference Standards is critical to every batch released, and characterization can be an arduous
process. In accordance with our QS, Reference Standards are produced and qualified prior to use in lot release, characterization
or stability testing. The objective of this program is to provide complete documentation of the establishment and trending of product
Reference Standards. Another goal of the program is to assess the suitability and availability of Reference Standards and critical reagents
to meet ICH and FDA guidelines appropriate for the product lifecycle stage for which the materials will be used. This program results
in complete documentation of these Reference Standards by providing:


 


		●	Manufacture
                                            according to approved batch record or protocol






		●	Qualification
                                            according to approved qualification protocol



		●	Lot
                                            release testing according to approved technical specification






		●	Generation
                                            of a COA detailing the lot release testing results



		●	Controlled
                                            storage conditions and inventory



		●	Stability
                                            testing






		●	Continual
                                            data trending and evaluation of suitability in new/revised analytical methods and/or with
                                            changes to manufacturing process operations



 


For
the Blue Water program, interim DS Reference Standards will be established in accordance with an approved protocol from the DS Engineering
lot(s). To reiterate the approach to DS Reference Standard, a minimum of 1,000 vials of Engineering DS will be aliquoted and qualified
as the DS Reference Standard. The filled Engineering DP generated in optional Task 7 will be labelled and qualified as the DP Reference
Standard. A QA-reviewed and approved Qualification Report will be provided that documents suitability of the DS and DP Reference Standards
in the intended methods. These interim DS and DP Reference Standards are to be used for Phase 1/2 product lot release and stability testing.


 


Task
5 Deliverables:


 


		●	DS
                                            Engineering Report






		●	DS
                                            Engineering Stability Protocol/Report



		●	Finalized
                                            BOM



		●	Finalized
                                            CGMP batch record templates






		●	Finalized
                                            CGMP DS Specifications



		●	Engineering
                                            non-CGMP DS COA and MSDS






		●	Updated
                                            Technology Transfer Protocol (if needed)



		●	Engineering
                                            non-CGMP DS Product



 





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	Manufacturing of
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Task
6: CGMP Drug Substance Run and Stability Testing 


 





Technical
Assumptions:


 


		●	Ology
                                            Bio CGMP WCB produced will be used.






		●	Ology
                                            Bio will perform one CGMP DS lot for the Streptococcus pneumoniae DS candidate at
                                            the 120 L scale.



 


Blue
Water and Ology Bio will agree on the analytical and in-process testing plan for the routine production of the Blue Water vaccine candidate,
which we will implement. The manufacturing processes that were developed and generated in Task 5 will be used for the DS candidate. Following
completion of the scalability studies, a Technology Transfer Protocol will be generated. This report will describe the process development
and define the critical process parameters and established ranges. The report will summarize lot testing and establish a sampling and
testing plan to be used during CGMP manufacturing. A BOM listing all required raw materials and components will be included. From this
BOM, specifications will be created for each material, as well as for in-process intermediates where required. Batch records will be
finalized and approved by QA for use in the CGMP manufacturing campaign. Any changes identified during the execution of the DP Engineering
Run (Task 5) will be incorporated into the final CGMP batch records prior to execution.


 


We
will perform one CGMP manufacturing campaign in accordance with:


 


		●	21
                                            CFR Parts 210 and 211 (CGMP)






		●	21
                                            CFR Part 312 (IND Application)



		●	21
                                            CFR Parts 600 and 610 (Biological Products)






		●	21
                                            CFR Part 11 (Electronic Records and Signatures)



 


To
lead to a successful campaign, we will use manufacturing readiness reviews
to ensure that all activities are completed prior to the start of manufacturing. We perform Area Clearance and Product Changeover according
to internal SOP-09-00054. Trained Operations personnel will clear manufacturing areas after manufacturing campaigns following work instruction
WI-09-00004. Areas are cleaned according to SOP-09-00006, including chlorine dioxide decontamination when appropriate. Activities are
documented on forms and manufacturing areas are released for use after QA review of these activities.


 


Our
QA team takes responsibility for assuring the quality and integrity of products and all data generated in compliance with the FDA GLPs
and CGMPs. QA provides review of manufacturing and testing operations as well as approval of specifications, Master Batch Records, procedures,
contract manufacturers, system and equipment changes, and intermediate and final product release. Deviations and investigations are integrated
in a corrective action system. QA review and approval activities will be carried out in support of CGMP production campaigns.


 


Documentation:


 


We
have a validated electronic Quality Management System, MasterControl, to automate and integrate processes for meeting quality standards
and complying with regulatory requirements. Master Control manages documents, training and risk; processes and audits; and facility and
equipment calibration and maintenance program. Documentation in MasterControl includes, but is not limited to, raw material specifications,
product specifications, MPR, equipment operation SOPs, and analytical method SOPs and protocols.


 


CGMP
manufacturing will be performed in compliance with CGMP regulations, including approved Master Batch Records, CGMP cell banks, active
environmental monitoring and QA release of all raw materials and consumables. Raw materials will be purchased using QA-approved material
specifications from QA-approved suppliers in accordance with our Supplier Selection, Assessment and Approval procedures (SOP-20-00018).
CGMP Runs will be performed in the manufacturing core using the same equipment, facilities and personnel as utilized for the Engineering
Run.


 


Production:


 


Trained
manufacturing personnel will execute one CGMP Production lot in accordance with QA-approved production records and SOPs. The CGMP Run
will be performed in the manufacturing core using the same equipment, facilities and personnel as utilized for the Engineering Run. The
manufacturing core features ISO 8 in-operation (Grade C) processing rooms for all closed system operations. All open manipulations will
occur within the ISO 5 area (Grade A BSC) located within an ISO 7 in-operation (Grade B) suite adjacent to the main processing room.
Samples will be taken throughout the manufacturing process according to the batch record and product specifications. The process will
be executed aseptically from start to finish, as demonstrated in the process simulation as part of Task 5. Bulk DS will be stored at
≤ - 70° C fill/finish at our facility.


 





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	Manufacturing of
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The
CGMP material will be tested according to the DS specifications and tests previously defined. QC conducts in-process and lot release
testing per SOPs and sampling plans. QA will provide the final review of batch records, environmental monitoring and analytical results.
QA will also provide release of CGMP DS via a COA, ensuring that the DS product lot meets all technical specifications and is acceptable
for use in GLP, nonclinical studies and Phase 1 clinical studies.


 


We
will perform limited stability testing as outlined in Task 5 and will provide samples as defined.


 


Task
6 Deliverables:


 


		●	QA-Approved
                                            Batch Production Records for the Streptococcus pneumoniae DS candidates






		●	QA-Approved
                                            COA(s)



		●	Stability
                                            testing samples, data and reports



		●	Campaign
                                            Summary Reports






		●	DS
                                            materials for DP formulation



 


Task
7: Engineering and CGMP Drug Product


 


Technical
Assumptions:


 


		●	Maximum
                                            DP lot size is 2,000 single-dose vials per lot.






		●	Intended
                                            DP storage temperature is < -20° C.



		●	A
                                            DP Engineering run will be required.






		●	DP
                                            process qualification runs will be required.



 


In
accordance with FDA Guidance for Industry, “Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing
Practice,” Sept 2004, aseptic formulation and fill validation (media
fill validation) will be conducted using a maximum of 2,000 vials per lot in a mutually approved container/closure system (vial, stopper,
seal). Three consecutive successful media fill Validation Runs will be performed using TBS to simulate the formulated DP according to
an approved media fill validation batch record. In addition, appropriate interventions (extended processing times, simulation of spillage
and clean-up of spillage, changing out of the fill needle) will be incorporated into the validation activities.


 


Phase
1 DP formulation and liquid product fill operations will be conducted at our facility. Using QA-approved production documentation, the
DS lot will be formulated to achieve the final concentration of the to-be-determined titer in the selected final formulation (determined
by Blue Water). Formulated product will be filled into the mutually approved container/closures within an aseptic area. A maximum of
2,000 vials per DP lot will be targeted for filling. QC will conduct lot release testing as summarized in Table 2 per batch records
and sampling plans. QA will provide the final review and release, ensuring that the DP lots meet all technical
specifications and are acceptable for use in GLP nonclinical studies and clinical studies. Stability testing of CGMP DP lots is described
in Table 5.


 


Task
7 Deliverables:


 


		●	DP
                                            Engineering Run Report






		●	Media
                                            Fill Qualification Report



		●	Up
                                            to 2,000 vials of CGMP DP per lot (two lots)



		●	COAs
                                            for released CGMP DP






		●	QA-approved
                                            batch production records (per lot, two lots)



		●	QA-approved
                                            Campaign Summary Report



 





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	Manufacturing
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		●	Stability
                                            study protocol



		●	Stability
                                            study report



 


Task
8: Preclinical IND-Enabling Studies


 


Technical
Assumptions:


 


		●	The
                                            non-CGMP Engineering lot will be used for the GLP toxicity study.



 


Subtask
8.1: Preclinical Tox Study


 


We
will support Blue Water in the development of a nonclinical safety plan to support IND filing. Based on our Regulatory experience, CBER/FDA
expects high-quality material for the IND-enabling toxicity studies that is either CGMP material or comparable to CGMP material. To reduce
risk, the schedule linked this study to the CGMP lot. Blue Water can consider risks as it reviews the nonclinical safety plan.


 


Our
Nonclinical SME will work with the subcontractor, IITRI, to develop a protocol for an IND-enabling study based on feedback received from
the FDA during the Pre-IND Meeting. We will oversee the performance of a GLP-compliant repeat-dose toxicity study of the Streptococcus
pneumoniae vaccine candidate in rabbits. The objective of the study will be to determine the immunogenicity, target organ toxicity,
and reversibility of the Streptococcus pneumoniae vaccine in rabbits following a repeat-dose regimen to support a Phase 1 clinical
study.


 


Task
8 Deliverables:


 


		●	Preclinical
                                            Study Plan development (PK and toxicity studies)






		●	Module
                                            3 for CGMP DS and DP



 


		3.	PROJECT
                                            SCHEDULE



 


The
proposed start date is May 2021; this start date is subject to change based on the date this proposal is accepted and signed and availability
of the facility.


 


	Task	 	Description	 	Start	 	End
	1	 	Technology Transfer and Process Development	 	May 2021	 	July 2021
	2	 	Analytical Assay Development	 	May 2021	 	July 2021
	3	 	CGMP Master Cell and Working Cell Banks	 	June 2021	 	November 2021
	4	 	Process Scale-Up and Optimization	 	July 2021	 	October 2021
	5	 	Engineering Drug Substance Run and Stability Testing	 	November 2021	 	January 2023
	6	 	CGMP Drug Substance Run and Stability Testing	 	December 2021	 	March 2023
	7	 	Engineering and CGMP Drug Product	 	December 2021	 	March 2023
	8	 	Preclinical IND-Enabling Studies	 	March 2023	 	August 2023


 





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	Manufacturing of
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4. PROJECT
BUDGET


 


	Task	 	Description	 	Original

Price	 	 	Discounted

for Analytics	 	 	Revised

Price	 
	 	 	 	 	 	 	 	 	 	 	 	 
	1	 	Technology Transfer and Process Development	 	$	286,000	 	 	 	0	%	 	$	286,000	 
	2	 	Analytical Assay Development	 	$	275,000	 	 	 	50	%	 	$	137,500	 
	3	 	CGMP Master Cell and Working Cell Banks	 	$	253,000	 	 	 	10	%	 	$	227,700	 
	4	 	Process Scale-Up and Optimization	 	$	451,000	 	 	 	10	%	 	$	405,900	 
	5	 	Engineering Drug Substance Run and Stability Testing	 	$	434,500	 	 	 	10	%	 	$	391,050	 
	6	 	CGMP Drug Substance Run and Stability Testing	 	$	605,000	 	 	 	10	%	 	$	544,500	 
	7	 	Engineering and CGMP Drug Product	 	$	616,000	 	 	 	10	%	 	$	554,400	 
	8	 	Preclinical IND-Enabling Studies	 	$	220,000	 	 	 	0	%	 	$	220,000	 
	 	 	TOTAL	 	$	3,140,500 	 	 	$	373,450 	 	 	$	2,767,050 	 


 


Note:
Material and outsourced testing costs are not included in the Project Costs and will be billed at cost plus a 15% material handling fee.
Estimated materials costs for the entire project are about 20% of total labor costs. Actual materials costs may vary based on information
determined during development of the process and potential changes to required scale or number of runs.


 





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	Manufacturing of
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5. PAYMENT
SCHEDULE


 








	Milestone	 	Description	 	Price	 
	 	 	 	 	 	 
	1	 	Tasks 1 and 2: Initiation Payment (50%)	 	$	211,750	 
	 	 	 	 	 	 	 
	2	 	Task 1: Completion: Technology Transfer & Process Development (50%)	 	 	 	 
		 	■ Final Schedule Agreement with Blue Water and Ology Bio at completion of this task.	 	 	 	 
	 	 	■ Project Management Plan including Project Charter	 	$	143,000	 
	 	 	■ Meeting agenda and minutes	 	 	 	 
	 	 	■ Draft Process Development Plan	 	 	 	 
	 	 	■ Process Establishment Plan and Report	 	 	 	 
	 	 	■ Preliminary BOM	 	 	 	 
	 	 	 	 	 	 	 
	3	 	Task 2: Completion: Analytical Assay Development (50%)	 	 	 	 
		 	■ Analytical assay Qualification Plan	 	$	68,750	 
	 	 	■ QA-reviewed and approved Qualification Report for each analytical method	 	 	 	 
	 	 	■ In-process and release assay specifications	 	 	 	 
	 	 	 	 	 	 	 
	4	 	Task 3: Initiation: CGMP Master Cell & Working Cell Banks (50%)	 	$	113,850	 
	 	 	 	 	 	 	 
	5	 	Task 3: Completion: CGMP Master Cell & Working Cell Banks (50%)	 	 	 	 
		 	■ Summary Report on cell banking and release for both MCB and WCB for the Streptococcus pneumoniae candidates including COAs and copies of Master Batch Records	 	$	113,850	 
	 	 	■ Cell bank stability plan for the candidate MCB and WCB for review/approval by Blue Water	 	 	 	 
	 	 	■ A minimum of 300 CGMP MCB vials	 	 	 	 
	 	 	■ A minimum of 300 CGMP WCB vials	 	 	 	 
	 	 	 	 	 	 	 
	6	 	Task 4: Initiation: Process Scale-Up & Optimization (50%)	 	$	202,950	 
	 	 	 	 	 	 	 
	7	 	Task 4: Completion: Process Scale-Up & Optimization (50%)	 	 	 	 
		 	■ Process Development Report for Blue Water review and approval	 	 	 	 
	 	 	■ Materials from the Process Development Runs	 	 	 	 
	 	 	■ Process Scale-up Plan	 	 	 	 
		 	■ Process Scale-up final report for review and approval by Blue Water	 	$	202,950	 
	 	 	■ Materials from the Scale-up runs	 	 		 
	 	 	■ Process parameters for the Engineering Run	 	 	 	 
	 	 	■ Technology Transfer Protocol	 	 	 	 
	 	 	■ Draft batch records and sampling plan for use in the Engineering Run	 	 	 	 
	 	 	■ Confirmation Run report and materials	 	 	 	 
	 	 	 	 	 	 	 
	8	 	Task 5: Initiation: Engineering Drug Substance Run (50%)	 	$	195,525	 
	 	 	 	 	 	 	 
	9	 	Task 5: Completion: Engineering Drug Substance Run (35%)	 	 	 	 
		 	■ Finalized BOM	 	 	 	 
		 	■ Finalized CGMP batch record templates	 	$	136,868	 
	 	 	■ Finalized CGMP DS Specifications	 	 	 	 
	 	 	■ Engineering non-CGMP DS COA and MSDS	 	 	 	 
	 	 	■ Updated Technology Transfer Protocol (if needed)	 	 	 	 
	 	 	■ Engineering non-CGMP DS Product	 	 	 	 
	 	 	 	 	 	 	 
	10	 	Task 5: Completion of 12-month Stability Testing (10%)	 	$	39,105	 
		 	■
    DS Engineering Stability Protocol/Reports	 	 	 	 
	 	 	 	 	 	 	 
	11	 	Task 5: Completion of 24-month Stability Testing (5%)	 			 
		 	■ DS Engineering Stability
Protocol/Reports	 	$	19,553	 













  





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	Manufacturing of
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	Milestone	 	Description	 	Price	 
	 	 	 	 	 	 
	12	 	Task 6: Initiation: CGMP Drug Substance Run & Stability Testing (50%)	 	$	272,250	 
	 	 	 	 	 	 	 
	13	 	Task 6: CGMP Drug Substance Run (35%)	 	 	 	 
		 	■ QA-Approved Batch Production Records for the Streptococcus pneumoniae DS candidates	 	$	190,575	 
	 	 	■ QA-Approved COA(s)	 	 	 	 
	 	 	■ Campaign
    Summary Reports	 	 	 	 
	 	 	■ DS materials for DP formulation	 	 	 	 
	 	 	 	 	 	 	 
	14	 	Task 6: Completion of 12-month Stability Testing (10%)	 	$	54,450	 
	 	 	■ DS Engineering Stability
    Protocol/Reports	 	 	 	 
	 	 	 	 	 	 	 
	15	 	Task 6: Completion of 24-month Stability Testing (5%)	 	$	27,225	 
	 	 	■ DS Engineering Stability Protocol/Reports	 	 	 	 
	 	 	 	 	 	 	 
	16	 	Task 7: Initiation: Engineering & GMP Drug Product (50%)	 	$	277,200	 
	 	 	 	 	 	 	 
	17	 	Task 7: Completion: Engineering Drug Product (15%)	 	 	 	 
		 	■ Media Fill Qualification Report	 	$	83,160	 
	 	 	■ Up to 2,000 vials of Engineering DP	 	 	 	 
	 	 	■ COA & DP Engineering Run Report	 	 	 	 
	 	 	 	 	 	 	 
	18	 	Task 7: Completion: CGMP Drug Product (20%)	 	 	 	 
		 	■ Up to 2,000 vials of CGMP DP	 	$	110,880	 
	 	 	■ COA for released CGMP DP	 	 	 	 
	 	 	■ QA-approved Batch Production Records	 	 	 	 
	 	 	■ QA-approved Campaign Summary Report	 	 	 	 
	 	 	 	 	 	 	 
	19	 	Task 7: Completion of 12-month Stability Testing for GMP Drug Product (10%)	 	$	55,440	 
	 	 	■ DP Stability Protocol/Reports for Engineering and GMP Drug Product	 	 	 	 
	 	 	 	 	 	 	 
	20	 	Task 7: Completion of 24-month Stability Testing for GMP Drug Product (5%)	 	$	27,720	 
	 	 	■ DP Stability Protocol/Reports for Engineering and GMP Drug Product	 	 	 	 
	 	 	 	 	 	 	 
	21	 	Task 8: Initiation: Preclinical IND-Enabling Studies (50%)	 	$	110,000	 
	 	 	 	 	 	 	 
	22	 	Task 8: Completion: Preclinical IND-Enabling Studies (50%)	 	$	110,000	 
	 	 	■ Preclinical Study Plan development (PK and toxicity studies)	 	 	 	 
	 	 	■ Module 3 for CGMP DS and DP	 	 	 	 
	 	 	 	 	 	 	 
	 	 	LABOR TOTAL	 	$	2,767,050	 








 



Note: Material
costs are not included in the Labor Total and will be billed at cost plus a 15% material handling fee.


 


6. MATERIALS


 


Materials
shall collectively mean all materials required for Production of Product, including the BDS, Components, Secondary Packaging Materials
and Raw Materials.


 


7. PAYMENT
TERMS


 


See schedule
above, Section 5


 





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	Manufacturing of
  Streptococcus pneumoniae Vaccine Candidate	May
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8.
STORAGE FEES


 


$350
/ month / freezer or refrigerator shelf


 


$1,200
/ month / entire freezer or refrigerator


 


9.
GENERAL ASSUMPTIONS


 


The
schedules, estimates and costs contained within this Project Addendum are based on the Listing of Technical Assumptions and the following
General Assumptions.


 


		1.	Ology
                                            Bio technological proposal is a suggested pathway based on the information provided. Additional
                                            and/or replacement of the techniques as a result of new and/or more (or less) detailed information
                                            from Blue Water may affect the content and pricing of this proposal.



 


		2.	Client
                                            acknowledges that process development tasks are experimental in nature and that no favorable
                                            or useful result can be assured by Ology Bio. However, in case of unfavorable results, the
                                            Parties shall in good faith, agree to a revision to the preliminary specifications that shall
                                            then be the Specifications for subsequent runs that shall form a basis for rejection or acceptance
                                            of the deliverable. The Client shall bear the cost of runs resulting in unfavorable results,
                                            if the unfavorable results were obtained by performing the tasks according to generally acceptable
                                            professional standards and procedures approved by the Client.



 


		3.	Information
                                            or issues discovered after contract award through the gap analysis performed on the technical
                                            transfer package provided to Ology Bio, or through analytical and/or process development
                                            activities, may require changes to proposed scope and costs. If such situations arise, Ology
                                            Bio will propose these changes to Client through a formal Change Request which will require
                                            Client approval before the changes can proceed.



 


		4.	Blue Water
                                            will make available the appropriate subject matter experts and stakeholders as needed.



 


		5.	Blue Water will
                                            provide sufficient materials required to begin assay development.



 


		6.	Ology Bio assumes
                                            that active and responsive participation and availability by Blue Water SMEs, stakeholders,
                                            etc., will exist throughout the length of this project in support of project scope, schedule,
                                            and team.



 


		7.	Access to development/practice/test
                                            documents will be available at contract start.



 


		8.	Full
                                            cooperation and conditions obtained from any/all applicable external third parties (manufacturers,
                                            service providers, leasers, etc.) required by the scope of this project will be acceptable
                                            to Ology Bio. Unfavorable conditions (terms, costs, etc.) will require that alternative solutions
                                            be found.



 


		9.	Timelines
                                            are bound to the specific period outlined in this proposal. As such, the appropriate space
                                            and resources will be allocated to this project during that timeframe. In the event of delays
                                            resulting in activity or inactivity of Blue Water, additional charges and an extension of
                                            the timeline may become necessary.



 


		10.	Ology Bio will
                                            work in good faith based on agreed upon terms and in cooperation of the needs of Blue Water.
                                            All activities associated with this project remains at the discretion of Ology Bio.



 


		11.	A
                                            mutually agreed-upon Decision Log will be used to make and record non-substantial changes/modifications
                                            to the contract without the need for a complete formal amendment. The Decision Log will be
                                            referenced as incorporated into the contract.



 


		12.	This
                                            estimate is valid for 60 days and until this proposal is signed as a contract document and
                                            agreed upon by both parties. Ology Bio reserves the right to adjust pricing based on new
                                            data, market cost fluctuations, and additional work requested by Blue Water prior to execution
                                            of the contract.



 


10.
MSA TERMS


 


All
of the terms and conditions set forth in the MSA, to the extent not expressly modified herein, are hereby incorporated into this Project
Addendum as if set out in full herein. If any terms in this Project Addendum conflict with the terms of the
MSA, the terms in the MSA will govern, except as specifically modified herein in accordance with the MSA. All capitalized terms not otherwise
defined herein shall have the meanings ascribed to such terms in the MSA or the Proposal.


 





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  Bioservices, Inc.	CONFIDENTIAL	14







     


     

    

 





	Manufacturing of
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IN WITNESS
WHEREOF, the parties have caused this Project Addendum to be executed by their duly authorized representatives.


 


	National Resilience, Inc.	 	Blue Water Vaccines, Inc.
	 	 	 	 
	By:	/s/ Timothy
    Cooke 	 	By:	/s/ Joseph
    Hernandez
	Name:  	Timothy Cooke	 	Name:  	Joseph Hernandez
	Title:	Co-Head, Vaccines
    Franchise	 	Title:	CEO
	Date:  	May
    28, 2021	 	Date:  	May
    21, 2021



 


 


 


 








	Ology
  Bioservices, Inc.	CONFIDENTIAL	15