Document:

Exhibit 10.1

 

 

AMENDMENT 1 TO PROJECT ADDENDUM 2 TO MASTER SERVICES
AGREEMENT

 

This Amendment 1 (the “Amendment”) is effectively
dated as of January 11, 2022 (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 to Client pursuant to the terms and conditions set forth in the MSA and any Project Addendum;

 

WHEREAS, Blue Water and Ology Bio entered into Project Addendum
II dated May 21, 2021 (“PA II”); and WHEREAS, the Parties desire to amend PA II in the manner described herein.

 

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:

 

Amendment

 

The Parties agree to Amend PA II by adding Task 9, as set forth
below, to provide additional regulatory support to Blue Water .

 

Task 9: Regulatory Support

 

Ology Bio Regulatory will provide CMC support to Client,
including preparing all CMC documents for submission in a regulatory application to the US FDA (i.e., Module 2 and Module 3 Quality Information).
The CMC information will be prepared for Client according to FDA and ICH guidance using templates that provide consistent granularity
for products in clinical development. Regulatory will provide CMC sections in CTD format in Microsoft Word documents along with a letter
of authorization (cross reference) to the ADM Alachua Florida Type 5 Site Master File to support the facility section (3.2.A). CMC writing
to support pre-submission briefing packages is included. The CMC information will support a Master File or IND submission as desired by
Client. If the application is for non-US dossiers, a facility section will be provided in the CMC to support regulatory filings.

 

Ology Bio Tier 2 Support shall include:

 

		●	Review of key CMC documents to determine if
supportive of product intended use, including specifications/batch analysis, DS and DP release and stability protocols/reports. For clarification,
this does not include manufacturing operations documentation (i.e. batch production records, sampling plans, raw material specifications,
media prep documents).
	 	 	 

		●	Review of applicable change controls related to the facility and program
for regulatory impact.
	 	 	 

		●	Module 2 and Module 3 Quality CMC technical
writing resulting in WORD CTD deliverables, supporting two complete rounds of review per document.

 

CMC consultation and guidance shall be limited to products
manufactured in ADM Facility or by ADM subcontractors specific to this project.

 

     

     

    

 

	Regulatory Support	November 17,2021

 

Section 3-Project Schedule: Section 3 of PAII shall
be amended to include Task 9, listed below:

 

	Task	 	Description	 	Start	 	End
	9	 	Regulatory Support	 	November 2021	 	TBD

 

Section 4, Project Budget: Section 4 of PA II
shall be amended to include the budget for Task 9, by adding the following language:

 

The budget for Task 9 is $300,000.

 

Section 5, Payment Schedule: Section 5 of PA II shall
be amended to include the Payment Schedule for Task 9 by adding the following language:

 

	Milestone	 	 	Description	 	Price	 
	 	23	 	 	Initiation of Task 9: Regulatory Support (50%)	 	$	150,000	 
	 	24	 	 	Completion of Task 9: Regulatory Support (50%)	 	$	150,000	 

 

Payment Terms

 

Ology Bio will invoice Client in the amounts and as provided
in the Payment Schedule above. Payment is due in accordance with Section 6.4 of the MSA.

 

Section 9, General Assumptions: Section 9 of PA II shall
be amended to include the following language:

 

13. The schedules, estimates and costs contained within
this Project Addendum are subject to the General Assumptions set forth in PA II.

 

PA II Terms:

 

This Amendment 1 is intended to supplement the scope of work
set forth in PA II. Except as expressly provided in this Amendment, all of the terms, conditions and general assumptions set forth in
PA II remain in full force and effect.

 

(Signature Page Follows)

 

    
	Ology Bioservices, Inc.	CONFIDENTIAL	2

     

    

 

	Regulatory Support	November 17,2021

 

IN WITNESS WHEREOF, the Parties have caused this Amendment
to be executed by their duly authorized representatives.

 

	Ology Bioservices, Inc.	 	Blue Water Vaccines, Inc.
	 	 	 	 	 
	By:	/s/ Todd Ranheim	 	By:	/s/ Joe Hernandez
	 	 	 	 	 
	Name: 	Todd Ranheim	 	Name:	Joe Hernandez
	 	 	 	 	 
	Title:	Head, Analytical Science & Technology	 	Title:	CEO
	 	 	 	 	 
	Date:	4/26/2022	 	Date:	4/19/2022

 

 

 

	Ology Bioservices, Inc.	CONFIDENTIAL	3Exhibit 10.2

 

EXCLUSIVE LICENSE
AGREEMENT

AMENDMENT #1

 

This Amendment (“Amendment”), effective
as of May 11, 2022 (Effective Date), amends that certain Exclusive License Agreement of January 27, 2020 by and between Blue Water
Vaccines, Inc. (Company) and St. Jude Children’s Research Hospital, Inc. (St. Jude) (the “License Agreement”).

 

WHEREAS the parties wish to revise the term of
the License Agreement to include the inventions disclosed in provisional patent application number 63/329,083, filed April 8, 2022, titled
“Vaccine Compositions and Methods for Reducing Transmission of Pathogens” (St. Jude File No. SJ-22-0020), developed by St.
Jude;

 

NOW THEREFORE, in consideration
of the above, the Parties agree that the following terms will apply.

 

Article 1.9 shall be revised to read:

 

1.9 “PATENT RIGHTS”
shall mean U.S. provisional patent application no. 61/537,290, titled “Live, Attenuated Streptococcus Pneumoniae Strain and Vaccine
for Protection Against Pneumococcal Disease” filed on September 21, 2011, which issued as US patent number 9,265,819 on February
23, 2016 and U.S. provisional patent application no. 62/817,748 filed March 13, 2019 and U.S. provisional patent application no. 63/329,083
titled “Vaccine Compositions and Methods for Reducing Transmission of Pathogens” filed April 8, 2022 owned by LICENSOR and
all invention(s) disclosed and claimed therein (“INVENTION”), and any issued patents, divisions, continuations, continuations-in-part
to the extent that the claims are directed to subject matter described in the above-referenced patent applications and are entitled to
the priority date of the existing PATENT RIGHTS, reexaminations, substitutions, renewals, restorations, additions or registrations thereof,
as well as non-United States counterparts thereof and extensions and supplementary protection certificates thereon.

 

EXHIBIT A shall be revised to read:

 

EXHIBIT A

 

LICENSE FEE & ROYALTIES

 

		1.	License Fee: The initial license fee due under Paragraph
3.1 within thirty (30) days of the EFFECTIVE DATE is fifteen thousand US dollars ($15,000). A first amendment fee of five thousand US
dollars ($5,000) is due within thirty (30) days of the Effective Date of this Amendment #1.

 

		2.	Annual Maintenance Fee: The annual maintenance fee
pursuant to Paragraph 3.2 is ten thousand US dollars ($10,000) per year, beginning on the first anniversary of the effective date of
the license.

 

		3.	Royalties: The running royalty rate payable under Paragraph
3.3 is five percent (5%).

 

In the event COMPANY is required to enter into one or more
third party license agreements to practice Patent Rights, the royalty payments due LICENSOR may be reduced by a percentage equal to half
of that paid to such third party. However, in no event shall the milestone payments due to LICENSOR be reduced by more than one half of
the original royalty percentage.

 

     

     

    

 

SUBLICENSE CONSIDERATION: COMPANY shall pay LICENSOR Fifteen
percent (15%) of any SUBLICENSE CONSIDERATION.

 

EXHIBIT B shall be revised to read:

 

EXHIBIT B

 

DEVELOPMENTAL MILESTONES & MILESTONE PAYMENTS

 

		1.	Developmental Milestones:  Developmental Milestones
by COMPANY for a LICENSED PRODUCT in accord with Paragraph 5.3 are as follows:

 

	Complete IND enabling study	2022/2023
	Initiate animal toxicology study	last half 2022
	File IND	last half 2023
	Complete PHASE I CLINICAL TRIAL	last half of 2024
	Commence PHASE II CLINICAL TRIAL	2025
	Commence PHASE III CLINICAL TRIAL	2027
	Regulatory approval, US or foreign equivalent	2030-2032

 

		2.	Milestone Payments: The Milestone Payments payable
under Paragraph 3.5 are as follows:

 

	Upon Commencement of PHASE III CLINICAL TRIAL	 	$	300,000	 
	Upon regulatory approval, US or foreign equivalent	 	$	600,000	 
	Upon FIRST COMMERCIAL SALE	 	$	1,000,000	 

 

“Commence” or “Commencement” of either a PHASE
I, PHASE II or PHASE III CLINCIAL TRIAL shall mean the dosing of the first patient in such PHASE I, PHASE II, or PHASE III CLINICAL TRIAL.

 

All other terms and conditions of the original
Exclusive License Agreement shall remain in full force and effect.

 

    2

     

    

 

IN WITNESS WHEREOF, the parties have caused this
Amendment to be duly executed as of the date first set forth above by their respective duly authorized offices.

 

	BLUE WATER VACCINES, INC.
	 	 	 
	/s/ Joseph Hernandez	 	Date 5/10/2022
	Name: 	 Joseph Hernandez	 	 
	Title: 	Chief Executive Officer	 	 
	 	 	 
	ST. JUDE CHILDREN’S RESEARCH HOSPITAL, INC.
	 	 	 
	/s/ J. Scott Elmer	 	Date
	J. Scott Elmer	 	 
	Director, Technology Licensing	 	 

 

 

3

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