Document:

Exhibit
10.13

 

 

PROJECT
ADDENDUM 1 TO MASTER SERVICES AGREEMENT

 

This
Project Addendum is effectively dated as of October 9, 2019 (the “Effective Date”) by and between Blue Water Vaccines, Inc.
a Delaware corporation located at 15 East Putnam Avenue, Suite 363, Greenwich, CT 06830 (“Blue Water”) and Ology Bioservices,
Inc., a Delaware corporation having a principal place of business at 13200 N.W. 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 Blue Water 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 for Services as set forth herein, subject to and in accordance with
the MSA.

 

WHEREAS,
Ology Bio submitted a Proposal dated May 22, 2019 to Blue Water.

 

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:

 

1.0
SCOPE OF WORK

 

Ology
Bio will perform Process Development and CGMP Manufacturing of Recombinant Influenza Conserved Regions for Vaccine Production for Blue
Water Vaccines, Inc. (Blue Water). Blue Water is currently developing a novel influenza vaccine based on conserved regions of the influenza
virus. Each of these conserved regions encodes a unique 15-20 amino acid peptide sequence. Blue Water has demonstrated the each of these
peptides is highly immunogenic and conserved over many different strains of influenza. Currently there are six (6) different conserved
regions that are being developed. These peptides are currently being combined into two separate expression vectors in E.coli.
Each of the two different combinations represent a single drug product. One will be used as the prime vaccine dose and the second will
be used as the boost dose. The present scope of work includes the timely process development and manufacture of the two novel influenza
vaccine drug substance candidates and production of the two different drug product candidates suitable for pre-clinical animal studies
and Phase 1 clinical studies.

 

This
project consists of eight Tasks required to manufacture and release a CGMP lot of Drug Substance (DS) and Drug Product (DP) suitable
for Clinical Development and conduct preclinical IND-enabling studies and prepare the IND. Specific details of each task are provided
in Section 2.0.

 

Task
1: Technology Transfer and Process Establishment

Task
2: Analytical Assay Development

Task
3: CGMP Master and Working Cell Banking

Task
4: Process Development and Scale-up

Task
5: Engineering Run and Stability Testing

Task
6: CGMP Run and Stability Testing

Task
7: Engineering Drug Product and Stability Testing

Task
8: CGMP Drug Product and Stability Testing

Task
9: Regulatory Support for Preclinical IND-Enabling Studies and IND Preparation

 

    Page 1 of 22
 

 

     

    

 

 

2.0
TECHNICAL APPROACH AND PLAN

 

Task
1: Technology Transfer and Process Establishment

 

Table
1. Task 1 Technical Assumptions

 

	Technical
    Assumption(s)
	Product-specific information (e.g., Bill of Materials, previous run data, intermediate stability data, any regulatory documentation, test methods) will be transferred within 5 business days of contract signing.
	The kick-off meeting will be scheduled within 10 business days of contract signing.
	Two Process Establishment runs will be performed at this stage using the established methodology provided by Blue Water.
	The upstream and downstream processing is similar between the different peptide constructs
	Blue Water will provide Research Cell Bank vials, reagents and standards and associated Certificates of Analysis, as
	required, to Ology Bio within 5 days of contract signing

 

Information
Transfer and Gap Assessment:

 

The
Information Transfer stage is critical for the success and timeliness of the project. Ology Bio requests that all pertinent documents
from Blue Water will be supplied within 5 days of contract signing to allow enough time for critical review by the Ology Bio 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. At
this time, it will be agreed upon by Blue Water and Ology Bio that the manufacturing processes are similar enough between the different
peptides that process development for only one will be sufficient and can be transferred to the other drug substance candidate. In collaboration
with Blue Water, we will create a Development Plan for each of the drug substances and governance process to meet the objectives of the
project. 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

 

    Page 2 of 22
 

 

     

    

 

 

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

                          

                         Blue
Water will provide Research Cell Bank (RCB) vials, reagents and standards, and associated Certificates of Analysis (COAs), as required,
to Ology Bio within 5 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.

                          

                         

Process
Establishment:

 

Ology
Bio will perform two Process Establishment Runs (one for each of the two candidates) to demonstrate the process for the Blue Water influenza
vaccine candidates at 3 L fermenter scale and prepare a process transfer final report for approval by Blue Water. Ology Bio will use
the existing RCBs from Blue Water to perform these runs. Upstream and Downstream Process Flow Diagrams for the production of the Blue
Water influenza vaccine candidate are shown in Figure 1 and Figure 2.

 

Limited
testing will be performed on these Establishment runs. These will include SDS- PAGE, protein concentration and HPLC analysis for purity.
We will also present a preliminary Bill of Materials (BOM) at the end of this task.

 

A
list of deliverables for Task 1 is shown in Table 2. 

 
	 	Figure 1. Upstream
  Fermentation 

                                                                    

                                                                   Figure
                                            2. Downstream Process Flow Diagram

                                                                   

 

    Page 3 of 22
 

 

     

    

 

 

Table
2. Task 1 Deliverables 

 

	Task	Deliverable
	Task 1: Technology Transfer and Process Establishment	Final Schedule Agreement with Blue Water and Ology Bio at completion of this stage
	Project Management Plan including Project Charter
	Meeting agenda and minutes
	Process development plan
	Process establishment plan and report
	Preliminary Bill of Materials

 

Task 2: Analytical Assay Development

 

Table 3. Task 2 Technical Assumptions

 

	Technical
                                            Assumption(s)

	Blue Water will provide analytical Reference Standards, product-specific reagents (antibodies) and initial samples of DS and DP for use in method transfer and validation
	All required analytical methods are summarized in Table 4
	Assay qualification will be phase appropriate
	Forced degradation studies will not be required on DS

 

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 Error! Reference source
not found. for in-process (IP) testing and DS testing. Each of these assays will need to be established for each of the two different
drug substance candidates. Stability and DP testing are described in Tasks 6 and 7, respectively. 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 4. In-Process and Drug Substance Release Testing

 

	Assay	Method	Location	Specification	Process
    Step
	Physiochemical Properties
	Appearance	
    Visual

    Observation
	Ology Bio	Clear, colorless liquid; no 

particles	DS
	pH	USP<791>	Ology Bio	TBD	IP, DS
	Conductivity	TBD	Ology Bio	TBD	IP
	Viability	Cell count	Ology Bio	TBD	IP
	Safety
	Endotoxin	USP<85>	Ology Bio	< 10 EU/dose; 

dose = 100 μg	IP, DS
	Bioburden	Membrane 

Filtration	Ology Bio	< 10 CFU/mL	IP, DS
	General Safety	21 CFR 610.11	Ology Bio	Pass	DS
	Content
	Protein Concentration	BCA	Ology Bio	Report	IP, DS

 

    Page 4 of 22
 

 

     

    

 

 

	Assay	Method	Location	Specification	Process
    Step
	Identity
	Presence of Blue Water Vaccine Candidate1	Western	Ology Bio	Identity Confirmed	IP, DS
	Purity
	Purity	SDS-PAGE	Ology Bio	TBD	IP, DS
	Host Cell DNA	E. coli qPCR 

assay	Ology Bio	TBD	DS
	Host Cell Protein	Kit	Ology Bio	TBD	DS
	Potency	 	 	 	 
	In vitro immunopotency	ELISA	Blue Water	TBD	DS

 

1Assay will be Tech Transferred to Ology Bio

 

A list of deliverables for Task 2 is shown in Table 5.

 

Table 5. Task 2 Deliverables

 

	Task	Deliverable
	Task 2: Analytical Assay Development	Analytical assay Qualification Plan for each analytical method for each of the two different drug substance candidates
	QA-reviewed and approved Qualification Report for each analytical method
	In-process and release assay specifications

 

Task 3: CGMP Master and Working Cell Banking

 

Table 6. Task 3 Technical Assumptions

 

	Deliverable
	A minimum of 300 CGMP MCB vials will be prepared for each of the two different drug substance candidates in support of this project
	A minimum of 300 CGMP WCB vials will be prepared for each of the two different drug substance candidates in support of this project
	RCB required for MCB production will be generated at Ology Bio in Task 4

 

In compliance with CGMP Regulations, Ology Bio will produce a minimum of 300 vials of a Master Cell Bank (MCB) for each of the two different
drug substance candidates per QA-approved batch production records using the RCBs generated by Ology Bio as part of Task 4. The new Blue
Horizon vaccine candidates will not contain a His-tag. 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 7. Ology Bio proposes to generate
CGMP Working Cell Banks (WCBs) from the MCBs of each of the two different drug substance candidates and characterize them.

 

    Page 5 of 22
 

 

     

    

 

 

Table 7. Cell Bank Release Assays

 

	Cell Bank Release
    Assay
	Strain ID/Purity-Differential Media
	Product ID-Dot or Western or SDS-PAGE
	Viability
	Growth Stability
	Plasmid Sequencing
	Plasmid Size
	Genetic Stability-Copy Number
	Genetic Stability-Plasmid Restriction Analysis
	Plasmid Retention/Antibiotic Resistance
	Bacteriophage

 

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 8.

 

Table 8. Cell Bank Stability Assays

 

	Cell
    Bank Stability Assays
	Growth Stability
	Viability
	Genetic Stability-Plasmid Restriction Analysis
	Plasmid Retention/Antibiotic Resistance

 

Table 9. Task 3 Deliverables

 

	Task	Deliverable
	Task 3: CGMP Master and Working Cell Banking	Summary Report on cell banking and release for both MCB and WCB for each of the two drug substance candidates including COAs and copies of Master Batch Records
	Cell bank stability plan for each of the two candidate MCB and WCB for review and approval by Blue Water
	A minimum of 300 CGMP MCB vials for each of the two drug substance candidates
	A minimum of 300 CGMP WCB vials for each of the two drug substance candidates

 

Task 4: Process Scale-up and Optimization

 

Table
10. Task 4 Technical Assumptions

 

	Technical
    Assumption(s)
	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 development of non-His-tagged influenza vaccine candidates
	Process Development will include generation of new RCBs for each of the two drug substance candidates
	Process Development will be performed on both drug substance candidates
	Six process development runs (three for each candidate) at the 3 L scale will be performed
	Two scale-up runs at the 120 L scale will be performed

 

    Page 6 of 22
 

 

     

    

 

 

The new plasmids provided
by Blue Water will be evaluated using two different E. coli expression systems: one based on IPTG induction, the other based on phosphate
depletion (PhoA). The expression system that yields the highest soluble titer will be selected for further development. We will initially
generate RCBs. We will identify three individual colonies from each of the two different drug substance candidates, and each of the colonies
will be analyzed for protein production at the 1-3 mL scale. Two colonies will be scaled up and used to generate 50 vials of RCB for
each candidate. 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 11.

 

Table
11. RCB Release Assays

 

	Release
    Assays
	Viability
	Growth Stability
	Plasmid Size
	Genetic Stability-Plasmid Restriction Analysis

 

These
RCBs will be used for the initial process development studies. The process development will include both candidates and on both 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. Ology Bio proposes to use their rapid chromatography screening protocols to identify and optimize the
chromatographic procedures required for the purification of the Blue Water vaccine candidate. Ology Bio proposes to scale-up the manufacturing
process to the 120 L scale. This will include six 3 L production runs (three for each candidate) to identify the optimum upstream parameters
for maximum production of the vaccine candidate. In parallel, the downstream processing will be optimized as described above and then
scaled to the 3 L scale. Ology Bio then proposes to perform two scale-up runs at the 120 L scale using the 150 L stainless steel 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).

 

Equipment
required to support all the required tasks for the program are in-place and have been previously qualified at the ADM Facility, as listed
in Table 12. Should additional equipment be required, qualification will be performed per standard operating procedures prior
to CGMP manufacturing.

 

Table
12. Equipment list for DS Manufacturing at the ADM Facility

 

	Item	ADM
    Equipment Identification
	Analytical
    Scale	Fisher
    XS2002S
	Autoclave	Fedegari
    Autoclave Model NA2420AW
	Centrifuge	Sorvall
    LYNX 6000
	Freezer	Revco
    High Performance -20° C Freezer
	Mixing
    Vessels	GE
    XDM-Quad Mixing Systems (50-500 L)
	Depth
    Filtration Systems	Millipore
    POD, 3M and Sartorius Holders available
	Chromatography
    System	GE
    Akta Ready
	TFF
    System	Sartorius
    Sartoflow Alpha Plus and Flex Act
	Fermenter	Eppendorf
    BioFlo Pro 120 L and 60 L
	Incubator
    Shaker	Eppendorf
    I42R
	Mini
    Fermenter System	Eppendorf
	Microscope	Fisher
    LMI-6001B
	Pump(s)	W/M
    Peristaltic Pump, 520SN/R2;

 

    Page 7 of 22
 

 

     

    

 

 

	Item	ADM
    Equipment Identification
	 	W/M Peristaltic Pump,520 Um AN/R2; 

W/M Peristaltic Pump, 323S/RL2
	Refrigerator	REL4504A Revco High Performance Refrigerator
	Scale	ABSCO SIWSDCS-1-35H-E7
	Water Bath(s)	Fisher Scientific Model 265/2866
	Vapor Phase Liquid Nitrogen (LN2) Freezer	Forma 7402 CryoPlus
	Stir Plate	Corning PC-240
	pH meter	Orion Versa Star Meter, pH/Conductivity
	Balance	ABSCO SIWSDCS-1-35H-E7
	Conductivity Meter	Orion Versa Star Meter, pH/Conductivity
	Class B Laminar Flow	NuAire BSC NU-430-600
	Pipette Aid	Numerous
	Micropipettor (200μL)	Numerous
	Micropipettor (1000μL)	Numerous
	Freezer ≤ -70° C	Thermo UFX600
	Autoclave for Decontamination	Fedegari NA2421AW
	Multipette	Numerous
	Balance	ABSCO SIWSDCS-1-35H-E7

 

Deliverables for this task are provided in Table 13.  

 

Table 13. Task 4 Deliverables

 

	Task	Deliverable
	Task 4: Process Development and Scale-Up	Process Development Report for Blue Water review and approval
	Material from the Process Development Runs
	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 Run and Stability Testing

 

Table 14. Task 5 Technical Assumptions

 

	Technical
    Assumption(s)
	Ology Bio proposes to perform one Engineering run for each of the two drug substance candidates (total of 2 runs) 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) for each of the six drug substance candidates

 

We will perform one Engineering run for each
of the two drug substance candidates at full scale of 120 L (total of two engineering runs). 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 the CGMP manufacturing core 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 3, Table
4.

 

    Page 8 of 22
 

 

     

    

 

 

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 15. Stability testing will be conducted per approved protocols and reported annually.

 

Table 15. Drug Substance Stability

 

	Test	Location	Acceptance Criteria	0m	1m	3m	6m	9m	12m
	pH	Ology Bio	TBD	X	X	X	X	X	X
	BCA	Ology Bio	TBD	X	X	X	X	X	X
	SDS-PAGE/Western blot/ densitometry to monitor protein degradation	Ology Bio	TBD	X	X	X	X	X	X
	Sterility	Ology Bio	No fungal or bacterial
    growth observed	X	 	 	 	 	X

 

    Page 9 of 22
 

 

     

    

 

 

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 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.

 

A list of deliverables for Task 5 is shown in Table 16.

 

	Table 16. Task 5 Deliverables
	 	 
	Task	Deliverable
	 	DS Engineering Report
	 	DS Engineering Stability Protocol/Report
	 	Finalized BOM
	Task 5: Engineering Run and	Finalized CGMP batch record templates
	Stability Testing	Finalized CGMP DS Specifications
	 	Engineering non-CGMP DS COA and MSDS
	 	Updated Tech Transfer Protocol (if needed)
	 	Engineering non-CGMP DS Products (two total)

 

Task 6: OPTIONAL – CGMP Run and Stability Testing

 

Table 17. Task 6 Technical Assumptions

 

	Technical
    Assumption(s)
	Ology Bio will use the CGMP WCB
	Ology Bio will perform one CGMP DS lot for each of the two drug substance candidates (total of two runs) at the 120 L scale

 

Blue Water and Ology Bio will agree on the analytical
and IP 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 both drug substance candidates. 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 IP 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 7) will be incorporated into the final CGMP batch records prior to execution.

 

    Page 10 of 22
 

 

     

    

 

 

 

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 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 on all the following activities:

 

		■	Documentation:
	 	 	 

		◌	Raw Material Specifications

		◌	Manufacturing Master and Executed Batch Records

		◌	Equipment Operation and Maintenance SOPs

		◌	Analytical Method SOPs

		◌	Cleaning and Disinfection SOPs

		◌	Harvest and Final Product Specification

 

		■	Manufacturing Cleanroom Preparation:
	 	 	 

		◌	Cleaning of Laboratory during Manufacturing

		◌	Area Clearance and Product Changeover

		◌	QA Audits

		◌	Cleaning Validation Risk Assessment/Protocol, if applicable

 

		■	Reference Standard:
	 	 	 

		◌	Certification of Reference Standard

 

		■	Raw Materials:
	 	 	 

		◌	Vendor Qualification

		◌	Ordering of Raw Materials and Supplies

		◌	Sampling of Raw Materials

		◌	QC Testing of Raw Materials and Data Review

		◌	QA Audit of Testing Data and Raw Material COAs

		◌	QA Release of Raw Materials and Inventory Tracking

 

		■	CGMP Manufacturing:
	 	 	 

		◌	Manufacturing of DS
	 	 	 

		■	Product Testing:

 

    Page 11 of 22
 

 

     

    

 

 

 

		◌	QC Review
of Testing Data

		◌	QA Review of Testing Data and Preparation of COAs

		◌	QA Release of DS Lot(s)

 

		■	Packaging and Shipping:
	 	 	 

		◌	Packaging and Shipping of DS

 

		■	Project Audit and Final Report

 

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 runs 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 7. Bulk DS will be stored at ≤ -70°C fill/finish at Ology Bio.

 

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.

 

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

 

A list of deliverables for Task 6 is shown in Error! Reference
source not found..

 

	Table 18. Task 6 Deliverables
	 	 
	Task	Deliverable
	Task 6: CGMP Run and Stability Testing	QA-Approved Batch Production Records for each of the two drug substance candidates
	QA-Approved COA(s) (per lot, total of two)
	Stability testing samples, data and reports
	Campaign summary reports
	DS materials for DP formulation

 

    Page 12 of 22
 

 

     

    

 

 

 

Task 7: Drug Product Engineering
Run

 

Table 19. Task 7 Technical Assumptions

 

	Technical
    Assumption(s)
	Two different drug products are required for this project
	Maximum DP lot size is 2,000 single-dose vials per lot
	Intended DP storage temperature is < -20°C
	DP will include an adjuvant provided by Blue Water with the final formulations
	DP process qualification runs will be required

 

After completing the DS Engineering run, Ology
Bio will execute an Engineering run of the DP filling process using the final container and closure method agreed upon with Blue Water
(anticipated to be a 2 mL vial) for each of the two Drug Products. The final formulation will include an adjuvant provided by Blue Water.
DP vials will be tested according to developed release criteria (Table 20) and placed on limited stability studies (Table 21).

 

Table 20. Drug Product Release Assay

 

	Assay	Method	Location	Specification	 
	Physiochemical Properties	 	 	 	 
	Appearance	Visual Observation	Ology Bio	Clear, colorless liquid; no particles	 
	pH	USP<791>	Ology Bio	7.4 ±0.3	 
	Osmolality	USP<785>	Ology Bio	250 – 350 mOsmol/kg	 
	Safety	 	 	 	 
	Endotoxin	USP<85>	Ology Bio	< 10 EU/dose; dose = 100 μg	 
	Sterility	21CFT610.2	Ology Bio	No growth ≥14 days	 
	Bioburden	Membrane Filtration	Ology Bio	< 10 CFU/mL	 
	General Safety	21CFR610.11	Ology Bio	Pass	 
	Content	 	 	 	 
	Protein Concentration	BCA	Ology Bio	Report	 
	Identity	 	 	 	 
	 	Western	Ology Bio	Identity Confirmed	 
	Presence
    pf Blue Water Vaccine Candidate	 
	 	 	 	 
	Purity	 	 	 	 
	Purity	SDS-PAGE	Ology Bio	>95% monomer	 
	Potency	 	 	 	 
	In vitro immunopotency	ELISA	Blue Water	TBD	 

 

    Page 13 of 22
 

 

     

    

 

 

 

Table 21. Drug Product Stability

 

	Test	Location	Acceptance
    Criteria	0d	1m	3m	6m	9m	12m	18m	24m	 
	Visual Inspection 	Ology Bio	No alum – no particles observed	X	X	X	X	X	X	X	X	 
	 
	 
	  Visual Inspection  	Ology Bio	With alum – white substance with no colored particles	X	X	X	X	X	X	X	X	 
	pH	Ology Bio	6.5 – 7.5	X	X	X	X	X	X	X	X	 
	BCA	Ology Bio	TBD	X	X	X	X	X	X	X	X	 
	In vitro immunopotency	Blue Water	TBD	X	X	X	X	X	X	X	X	 
	SDS/PAGE/Western blot/densitometry to monitor protein degradation	Ology Bio	TBD	X	X	X	X	X	X	X	X	 
	Sterility	Ology Bio	No fungal or bacterial growth observed	X	 	 	 	 	X	 	X	 

 

A list of deliverables for Task 7 is shown in Error! Reference
source not found..

 

	Table 22. Task 7 Deliverables	 
	 	 	 
	Task	Deliverable	 
	 	DP Development Plan	 
	 	DP Development Report	 
	 	Non-CGMP Engineering Run DP vials suitable for use in preclinical studies	 
	Task 7: DP Engineering Lots	DP Engineering Summary Report consisting of release testing results	 
	Media Fill Qualification Report	 
	 	 
	 	Up to 2,000 vials of Engineering DP per lot (two lots)	 
	 	Stability study protocol	 
	 	Stability study report	 

 

Task 8: OPTIONAL – CGMP Drug Product

 

Table 23. Task 8 Technical Assumptions

 

	Technical
    Assumption(s)
	Two different drug products are required for this project
	Maximum DP lot size is 2,000 single-dose vials per lot
	Intended DP storage temperature is < -20°C
	DP will include an adjuvant provided by Blue Water with the final formulations
	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.

 

    Page 14 of 22
 

 

     

    

 

 

 

Phase 1 DP formulation and liquid product fill
operations will be conducted at Ology Bio. 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 Error! Reference source not found. 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 Error! Reference source not
found..

 

A list of deliverables for Task 7 is shown in Table 24.

 

	Table 24. Task 8 Deliverables	 
	 	 	 
	Task	Deliverable	 
	 	Up to 2,000 vials of CGMP DP per lot (two lots)	 
	 	COAs for released CGMP DP	 
	Task 7: DP CGMP Lots	QA-approved batch production records (per lot, two lots)	 
	QA-approved Campaign Summary Report	 
	 	 
	 	Stability study protocol	 
	 	Stability study report	 

 

Task 9: Regulatory Support for Preclinical IND-Enabling Studies
and IND Preparation

 

Table 25. Task 9 Technical Assumptions

 

	Technical
    Assumption(s)
	Regulatory support for two different drug substance candidates and two drug product candidates is required
	Non-CGMP Engineering lot will be used for the toxicity study
	Ology Bio assumes that clinical SMEs will be provided by the Sponsor to support protocol development and review
	Electronic Publishing costs are not included in this proposal

 

Subtask 9.1: Pre-Clinical Tox Study

 

Ology Bio will support Blue Water in the development
of a nonclinical safety plan to support IND filing. Based on Ology Bio Regulatory experience, CBER/FDA expects high-quality of 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.

 

Ology Bio’s 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
(Subtask 8.2). Ology Bio will oversee the performance and of a GLP-Compliant Repeat Dose Toxicity Study of the Influenza Vaccine Candidate
in Rabbits. The objective of the study will be to determine the immunogenicity, target organ toxicity, and reversibility of the influenza
vaccine in rabbits following a repeat dosing regimen to support a Phase 1 clinical study.

 

Subtask 9.2: Pre-IND Meeting Support

 

Ology Bio will support a Type B Pre-IND Meeting
to ensure successful entry into first-in-man studies. Effective communication with the FDA during the pre-IND stage of product development
fosters a strong working relationship and is important for clearance of the IND. Ology Bio Regulatory Affairs (RA) team will respond to
information requests received prior to the meeting, support meeting participation and prepare meeting minutes.

 

    Page 15 of 22
 

 

     

    

 

 

 

Our RA team will be engaged in practice
sessions to develop responses to potential FDA questions and address concerns to avoid delays in product development. Our RA team tracks
risks associated with entry into clinical development and ensures that the meeting reduces risk by proper preparation.

 

The Pre-IND meeting will include briefing
materials describing the Phase 1 Protocol Synopsis; nonclinical toxicity plan; CMC technical information including cell banking and detailed
manufacturing process descriptions; release; and stability information. Specific questions will focus on acceptability of the information
to be provided in the IND.

 

Subtask 9.3: Regulatory Technical Writing

 

To support Blue Water in developing
their IND application, our RA experts will prepare CMC sections for Blue Water’s vaccine. Ology Bio will provide Tier 1, Tier 2
and Tier 3 regulatory support, which includes technical review of strategic documents (i.e., specifications, change controls, protocols,
risk assessments and technical reports) and CMC technical writing. Ology Bio will author the DS CMC information (Quality Modules 3.2.S,
3.2.P and 3.2A) in ICH Common Technical Document (CTD) format, delivered as Microsoft Word documents. CMC technical writing will be limited
to manufacturing and testing activities managed by Ology Bio, and placeholders will be included for Blue Water-managed activities. In
addition, Ology Bio will support development of Modules 4 and 5 with deliverables provided in Word. Electronic Publishing costs are not
included in this proposal.

 

The Ology Bio RA team is responsible
for managing, writing, completing or editing all technical writing assignments; obtaining drop-in documents from the SMEs; assembling
all documents and forms into a submission package; and uploading the submission for review and approval. Our RA team works with SMEs as
needed to complete editing and addressing reviewers’ comments. RA is responsible for working with QA staff to ensure that all information/data
has been reviewed for accuracy prior to Client review of documents. For this effort, Ology Bio assumes that clinical SMEs will be provided
by the Sponsor to support protocol development and review.

 

Our RA team uses eCTD Word templates
that provide authors with the ability to create documents that adhere to a single standard for consistency to the FDA and to our clients.
Scientifically sound and accurate CMC writing to support CTD Module 3 development is critical to the success of the CMC communications
with Regulatory authorities. Cost and regulatory operations support for electronic publishing and filing of the IND is not included.

 

Table 26. Task 9 Deliverables

 

	Task	Deliverables
		
	 	Preclinical study plan development (PK and toxicity studies)
	 	Preclinical Protocol Drafts
	Task 8: Regulatory Support for Preclinical IND-	Module 3 for CGMP DS and DP
	Enabling Studies and IND Preparation	IND support documentation (MS Word Deliverables)
	 	Clinical trial documentation to support Phase 1 clinical study
	 	(Investigator Brochure and Phase 1 Protocol)

 

    Page 16 of 22
 

 

     

    

 

 

3. PROJECT SCHEDULE

 

The project schedule is presented in Table
27. The proposed start date for this project is September __, 2019; this start date is subject to change based on the date this proposal
is accepted and signed and availability of the facility.

 

Table 27. Project Schedule

 

	Task	Description	Start	End
	1	Technology Transfer and Process Establishment	Oct 2019	Jan 2020
	2	Analytical Assay Development	Oct 2019	Feb 2020
	3	CGMP Master and Working Cell Banking, Stability	Nov 2019	Feb 2021
	4	Process Development and Scale-up	Jan 2020	Jun 2020
	5	Engineering Run and Stability Testing	Jun 2020	Aug 2021
	6	OPTIONAL: CGMP Run and Stability Testing	Aug 2020	Oct 2021
	7	DP Engineering Lot	Jun 2020	Sep 2021
	8	OPTIONAL: CGMP DP Lot	Sep 2020	Oct 2021
	9	Regulatory Support for Preclinical IND-Enabling Studies and IND Preparation	Jul 2020	Jul 2021

 

 4. PROJECT BUDGET

 

Table 28. Project Budget

 

	Task	Description	Task
    Price1	Pass-Through
    Costs2	Total
    with Estimated Pass-Through 
	1	Technology Transfer and Process Establishment	$171,000	$6,000	$177,000
	2	Analytical Assay Development	$225,000	$27,000	$252,000
	3	CGMP Master & Working Cell Banks	$306,000	$230,000	$536,000
	4	Process Development and Scale-Up	$324,000	$413,000	$737,000
	5	Engineering Runs and Stability Testing	$444,000	$347,000	$791,000
	6	OPTIONAL: CGMP Runs and Stability Testing	$594,000	$489,000	$1,083,000
	7	DP Engineering Lot and Stability Testing	$357,000	$79,000	$436,000
	8	OPTIONAL: CGMP DP Lot and Stability Testing	$393,000	$84,000	$477,000
	9.1	Pre-Clinical Tox Study3 and Protocols	$166,000	$325,000	$491,000
	9.2	Pre-IND Meeting Support	$253,000	$0	$253,000
	9.3	Regulatory Technical Writing	$333,000	$0	$333,000
	TOTAL – with optional tasks	$3,566,000	$2,000,000	$5,566,000
	TOTAL – optional tasks (6 & 8)	$987,000	$573,000	$1,560,000
	TOTAL – without optional tasks	$2,579,000	$1,427,000	$4,006,000

 

		1	Task
prices are based on estimated time.

		2	Material
costs are estimated for budgeting purposes and include a 15% material handling fee.

		3	GLP
compliant IND-enabling tox study performed by Ology Bio subcontractor

  

    Page 17 of 22
 

 

     

    

 

 

 

5. PAYMENT SCHEDULE

 

Table 29. Payment Schedule

 

	Payment
    Table
	Milestone	Task	Description	Deliverables	Payment
	MS1	1 – 4	Initiation of Tasks 1 – 4 (50%)	 	$513,000
	MS2	1	Technology Transfer and Process Establishment	
    ●   Final
    Schedule Agreement

    ●   Project
    Management Plan

    ●   Project
    Charter Process Development Plan

    ●   Process
    Establishment Plan and Report

    ●   Preliminary
    Bill of Materials
	$85,500
	MS3	2	Analytical Assay Development	
    ●   Analytical
    Assay Qualification Plan

    ●   Approved
    Qualification Reports
	$112,500
	●   In-Process and Release Assay Specifications
	MS4	3	CGMP Master & Working Cell Banks	●   Draft MCB Master Batch Record	$153,000
	
    ●   Executed
    MCB Master Batch Record

    ●   Draft
    WCB Master Batch Record

    ●   Executed
    WCB Master Batch Record

    ●   Approved
    Stability Study Plan for MCB

    ●   Approved
    Stability Study Plan for WCB

    ●   Minimum
    of 300 cGMP MCB Vials

    ●   Minimum
    of 300 cGMP WCB Vials

	MS5	4	Process Development and Scale-Up	
    ●   Approved
    Process Development Report

    ●   Process
    Development Run Materials

    ●   Approved
    Process Scale-Up Final Report

    ●   Scale-Up
    Run Materials

    ●   Engineering
    Run Process Parameters

    ●   Technology
    Transfer Protocol

    ●   Draft
    Batch Records

    ●   Sampling
    Plans

    ●   Confirmation
    Run Report

    ●   Confirmation
    Run Materials
	$162,000
	MS6	5	Initiation of Task 5 (50%)	 	$222,000
	MS7	5a Engineering Run	
    ●   DS
    Engineering Report

    ●   DS
    Engineering Stability Protocol

    ●   Finalized
    BOM

    ●   Finalized
    CGMP Batch Record Templates

    ●   Finalized
    CGMP DS Specifications

    ●   Engineering
    Non-CGMP DS COA MSDS

    ●   Updated
    Tech Transfer Protocol (if needed)

    ●   Engineering
    Non-CGMP DS Product
	$205,350
	MS8	5b Engineering Run Stability Testing	●   DS Engineering Stability Report	$16,650

 

    Page 18 of 22
 

 

     

    

 

 

 

	MS9	7	Initiation of Task 7 (50%)	 	$178,500
	MS10	7a Engineering Drug Product	
    ●  DP
    Development Plan

    ●  DP
    Development Report

    ●  Non-CGMP
    Engineering Run DP Vials Suitable Preclinical Studies

    ●  DP
    Engineering Summary Report
	$89,250
	MS11	7b Engineering Drug Product Stability Testing (12 months)	
    ●  Stability
    Study Protocol

    ●  Interim
    Stability Study Report
	$44,625
	MS12	7c Engineering Drug Product Stability Testing (24 months)	●  Final Stability Study Report	$44,625
	MS13	9.1	Initiation of Pre-Clinical Tox Study and Protocols	 	$83,000
	MS14	Completion of Pre-Clinical Tox Study and Protocols	●  Preclinical Study Plan Development	$83,000
	
           (PK and Toxicity Studies)

    ●  Preclinical
    Protocol Drafts

	MS15	
    9.2

     

     

     

    

 

 

     

    9.3
	Initiation of Pre-IND Meeting Support	 	$126,500
	MS16	Completion of Pre-IND Meeting Support	
    ●  Module
    3 for CGMP DS and DP

    ●  IND
    Support Documentation (MS Word Deliverables)
	$126,500
	MS17	Initiation of Regulatory Technical Writing	 	$166,500
	MS18	Completion of Regulatory Technical Writing	●  Clinical Trial Documentation to Support Phase 1 Clinical Study	$166,500
	Labor Total	$2,579,000
	Estimated Consumable Pass-Through Costs	$1,427,000
	Estimated Overall Total	$4,006,000

 

    Page 19 of 22
 

 

     

    

 

 

 

Table 30. Optional Tasks Payment Schedule

 

	Payment
    Table (Optional Tasks)
	Milestone	Task	Description	Deliverables	Payment
	MS19	6	Initiation of Task 6 (50%)	 	$297,000
	MS20	6a CGMP Run	
    ●   QA-Approved
    Batch Production Records

    ●   QA-Approved
    COA(s) (per lot)

    ●   Stability
    Testing Samples

    ●   Campaign
    Summary Report

    ●   DS
    Materials for DP Formulation
	$282,150
	MS21	6b CGMP Run Stability Testing	
    ●   Stability
    Testing Data

    ●   Stability
    Testing Reports
	$14,850
	MS22	8	Initiation of Task 8 (50%)	 	$196,500
	MS23	8a CGMP Drug Product	
    ●   Media
    Fill Qualification Report

    ●   Up
    to 2,000 Vials of CGMP DP
	$98,250
	
    ●   COAs
    for Released CGMP DP

    ●   QA-Approved
    Batch Production Records

    ●   QA-Approved
    Campaign Summary Report

	MS24	8b CGMP Drug Product Stability Testing (12 months)	
    ●   Stability
    Study Protocol

    ●   Interim
    Stability Study Report
	$49,125
	MS25	8c CGMP Drug Product Stability Testing (24 months)	●   Final Stability Study Report	$49,125
	Labor Total	$987,000
	Estimated Consumable Pass-Through Costs	$573,000
	Estimated Overall Total	$1,566,000

 

6. MATERIALS

 

Materials will be invoiced to Blue Water as per Section 3.3 of the
MSA.

 

7. PAYMENT TERMS

 

Payment terms are defined in Section 6.4 of the MSA.

 

8. STORAGE FEES

 

$350 / month / freezer or refrigerator shelf

 

$1,200 / month / entire freezer or refrigerator

 

    Page 20 of 22
 

 

     

    

 

 

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 Technical Approach is a suggested pathway based on the information provided in the Blue Water Request for Proposal (RFP).
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.

 

2. 
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 Blue Water through a formal Change Request which will require Blue Water approval before
the changes can proceed.

 

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

 

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

 

5. 
Blue Water 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.

 

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

 

7. 
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.

 

8. 
Timelines are bound to the specific period outlined in this Project Addendum. 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.

 

9. 
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.

 

10. 
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.

 

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.

 

    Page 21 of 22
 

 

     

    

 

 

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

 

	Ology Bioservices, Inc.	 	Blue Water Therapeutics, Inc.
	 	 	 	 	 
	By:	/s/ Timothy Cooke	 	By:	/s/ Joe Hernandez
	Name:	Timothy Cooke	 	Name:	Joe Hernandez
	Title:	 	 	Title:	 

 

    Page 22 of 22Exhibit 10.14

 

 

 

09 January 2020

 

Joseph Hernandez

Chief Executive Officer

Blue Water Vaccines, Inc.

15 East Putnam Avenue, Suite 363

Greenwich, CT 06830

 

Dear Mr. Hernandez,

 

Reference is made to that certain Master
Services Agreement (“Agreement”) dated July 19, 2019 by and between Ology Bioservices, Inc. (“Ology Bio”) and
Blue Water Vaccines, Inc. (“Blue Water”, together the “Parties”), and to the Agreement Project Addendum
(“Project Addendum”) dated October 18, 2019 and attached to the Agreement as Exhibit A.

 

Per the terms
of the Project Addendum, Blue Water was to remit $513,000 to Ology Bio for the initiation of Tasks 1-4 (the “Initiation Payment”),
due on November 21, 2019. As of January 1, 2020, Ology Bio has received $100,000 of this Initiation Payment and has incurred $51,400 of
costs performing services under the Project Addendum to date.

 

Due to unforeseen
circumstances in which Blue Water is unable to provide lead candidates and constructs required for Ology Bio to begin work on Tasks 1-4
as detailed in the Project Addendum, the Parties agree that Ology Bio will stop work effective immediately.

 

The Parties further agree that Ology Bio will resume work on Tasks 1-4 in the Project Addendum at Blue Water’s
request and upon remittance of the remaining $413,000 of lnitiation Payment to Ology Bio.

 

	Sincerely,	 
	 	 
	/s/ Andras Cziotka	 
	Andras Cziotka	 
	VP, Legal Affairs	 
	 	 
	Accepted and Agreed:	 
	 	 
	/s/ Joseph Hernandez	 
	Joseph Hernandez	 
	Chief Executive Officer	 
	Blue Water Vaccines, Inc.

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