Exhibit 10.8


 


EXCLUSIVE LICENSE AGREEMENT


 


THIS EXCLUSIVE LICENSE AGREEMENT
(the “Agreement”) is made and effective as of June , 2021 (the Effective Date”) by and between Blue Water
Vaccines ___________________________________, having a principal place of business at 201 E Fifth Street, Suite 1900 Cincinnati, OH 45202
(“Company”), and Children’s Hospital Medical Center, d/b/a Cincinnati Children’s Hospital Medical Center
(“CHMC”), having a principal place of business at 3333 Burnet Avenue, Cincinnati, Ohio 45229-3039, USA.


 


INTRODUCTION


 


WHEREAS, CHMC owns certain
Patents and Technology, as defined in Article 1 of this Agreement, which it desires to make available for the development and commercialization;
and


 


WHEREAS, Company desires
to obtain certain license rights to the Patents and Technology; and


 


WHEREAS, Company has represented
to CHMC, to induce CHMC to enter into this Agreement, that Company has the desire, expertise and knowledge to develop, produce, market
and sell Products and/or to use Processes and that it will commit itself to a thorough, vigorous and diligent program exploring the Technology
and inventions claimed in the Patents such that public benefit from the Processes and/or Products will result.


 


NOW, THEREFORE, in consideration
of the mutual covenants and promises contained in this Agreement and other good and valuable consideration, CHMC and Company agree as
follows:


 


ARTICLE 1 - DEFINITIONS


 


In the terms defined and
used herein, the singular will include the plural and vice versa. Undefined terms in this Agreement (other than names of parties and
Article headings) which are set forth in upper case letters have the meanings established for such terms in the succeeding Paragraphs
of this Article 1.


 


		1.1	“Affiliate” means, with
                                            respect to Company, any corporation, limited liability company or partnership which is controlled
                                            by Company. “Control” means that one of the following conditions is met:
                                            (a) in the case of corporate entities, direct or indirect ownership of more than fifty percent
                                            (50%) of the stock or shares having the right to vote for the election of directors or otherwise
                                            to direct or cause the direction of management, and (b) in the case of non-corporate entities,
                                            direct or indirect ownership of more than fifty percent (50%) of the equity interest with
                                            the power to direct or cause the direction of the management of such non-corporate entities.
                                            A company will only be deemed to be an Affiliate for so long as such control exists. Company’s
                                            Affiliates as of the Effective Date are set forth on Exhibit A to this Agreement.



 


		1.2	“Confidential Information”
                                            will have the meaning set forth in Paragraph 11.3.



 


		1.3	“Field of Use” means utilizing
                                            the Patents and Technology for all uses other than the Excluded Field



 


		1.4	“Excluded Field” means immunization
                                            against, and prevention, control, or reduction in severity of gastroenteritis caused by Rotavirus
                                            and Norovirus in China and Hong Kong.



 


		1.5	“Government” means the
                                            federal, state and/or local government(s) and regulatory bodies of any country or multinational
                                            governmental entities within the Territory.



 






     


    


    

 


		1.6	“Improvement” means any
                                            CHMC Improvements or Company Improvements, as defined in Article 7.



 


		1.7	“Net Sales” means the
                                            aggregate invoice sales prices, license fees or other amounts charged by Company, its Affiliates,
                                            and its Sublicensees from the sale, lending, lease, license or other distribution or disposal
                                            of Products, Processes, Company Improvements, products that use a process that is a Company
                                            Improvement, or processes that use a product that is a Company Improvement to third parties
                                            in accordance with this Agreement less only credits actually granted on account of regular
                                            trade and discount allowances, recalls, rejection or return of items previously sold, all
                                            taken in accordance with GAAP. No other deductions will be made in the calculation of Net
                                            Sales, including, without limitation, for any commissions, cost of collections, transportation,
                                            insurance, storage, or other expenses.



 


		1.8	“New Drug Application”
                                            or “NDA” means (i) a New Drug Application as defined in the United States
                                            Federal Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder from
                                            time to time, and all amendments and supplements thereto filed with the FDA or (ii) the equivalent
                                            application, including, without limitation, a marketing authorization application filed with
                                            any equivalent agency or governmental authority in the European Union (such as the EMEA)
                                            requiring such filing, including all documents, data and other information concerning a pharmaceutical
                                            product which are necessary for gaining Regulatory Approval to market and sell such pharmaceutical
                                            product.



 


		1.9	“Patents” means the patents
                                            and patent applications listed on Exhibit B hereto and any patents maturing from any
                                            of the foregoing that are patent applications, and any divisionals, continuations and continuations-in-part
                                            (solely to the extent that the claims in such continuations-in-part are directed to subject
                                            matter specifically claimed in the Patents listed on Exhibit B, and they have the
                                            same priority date of such Patents, but not including any additional or different claims),
                                            and the resulting patents therefrom.



 


		1.10	“Phase I Clinical Trials”
                                            means a human clinical trial that is designed to determine the metabolism, pharmacologic
                                            actions (including pharmacodynamics) and pharmacokinetics of a drug in humans, the safety
                                            profile, tolerability and any potential side effects of the drug associated with increasing
                                            doses and that satisfies the requirements of 21 CFR 312.21(a), or its successor regulation
                                            or its equivalent in any other jurisdiction in the Territory.



 


		1.11	“Phase II Clinical Trials”
                                            means a clinical trial that is designed to establish the safety and preliminary efficacy
                                            of a drug for its intended use, and to define warnings, precautions and adverse reactions
                                            that are associated with the drug in the dosage range to be prescribed and that satisfy the
                                            requirements of 21 CFR 312.21(b) (or its successor regulation) or its equivalent in any other
                                            jurisdiction in the Territory.



 


		1.12	“Phase III Clinical Trials”
                                            means a clinical trial on sufficient numbers of patients that, if the defined end-points
                                            are met, are designed (and agreed to by the FDA, or other Regulatory Authorities in the Territory)
                                            based upon existing data in the same patient population as of the start of the trial to definitively
                                            establish that a drug is safe and efficacious for its intended use, and to define warnings,
                                            precautions and adverse reactions that are associated with the drug in the dosage range to
                                            be prescribed, and which provide pivotal data supporting Regulatory Approval of such drug
                                            or label expansion of such drug and that satisfy the requirements of 21 CFR 321.21(c), or
                                            its successor regulation or its equivalent in any other jurisdiction in the Territory.



 






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		1.13	“Process” means a process
                                            which is disclosed in the Patents or Technology, or a process that uses a product that is
                                            disclosed in the Patents or Technology.



 


		1.14	“Product” means a product
                                            which is disclosed in the Patents or Technology, or a product which is developed, tested,
                                            screened or made in whole or part using a process disclosed in the Patents or Technology.



 


		1.15	“Regulatory Approval”
                                            means any approvals (including supplements, amendments, pre- and post-approvals and price
                                            approvals), licenses, registrations or authorizations (including any designations of an indication
                                            for a Product as an “Orphan Product” under the Orphan Drug Act), howsoever called,
                                            of any Regulatory Authority, which are necessary for the distribution, importation, exportation,
                                            manufacture, production, use, storage, transport or clinical testing and/or sale of a Product
                                            or Process in a regulatory jurisdiction. Regulatory Approval will not include any site license
                                            for a Company manufacturing facility.



 


		1.16	“Regulatory Authority”
                                            means the United States Federal Drug Administration (“FDA”) or any counterpart
                                            of the FDA outside the United States, or other national, supra-national, regional, state
                                            or local regulatory agency, department, bureau, commission, council, ethics committee, review
                                            board or other entity with authority over the distribution, importation, exportation, manufacture,
                                            production, use, storage, transport or clinical testing and/or sale of a Product or Process
                                            hereunder.



 


		1.17	“Regulatory Filings”
                                            means, collectively, Investigational New Drug applications, Biologics License Applications,
                                            NDAs, establishment license applications (ELAs) and drug master files (DMFs), applications
                                            for designation of a Product as an “Orphan Product(s)” under the Orphan Drug
                                            Act, Orange Book filings, responses to FDA “Written Requests,” Premarket Notification
                                            510(k). Premarket Approval (PMA), Investigational Device Exemption (IDE),or any other filings
                                            (including any foreign equivalents and further including any related correspondence and discussions),
                                            and all data contained therein, as may be required by the FDA or equivalent Regulatory Authorities
                                            for the development, manufacture or commercialization of a Product or Process hereunder.



 


		1.18	“Sublicensee” means any
                                            business entity other than an Affiliate to whom Company sublicenses the rights set forth
                                            in Paragraph 3.2 hereof



 


		1.19	“Technology” means any
                                            technical information in existence and known before the Effective Date by CHMC that are necessary
                                            for the use or practice of the Patents contemplated hereunder in the Field of Use, solely
                                            to the extent. To the extent not patented or otherwise published, the Technology constitutes
                                            part of CHMC’s Confidential Information.



 


		1.20	“Term” means the period
                                            beginning on the Effective Date and extending on a jurisdiction by jurisdiction and product
                                            by product basis, the later of:



		(i)	the last to expire Patent,



		(ii)	10 years after the first commercial
                                            sale, or



		(iii)	Entrance
                                            onto the market of a biosimilar or interchangeable product



 


		1.21	“Territory” means worldwide.



 


		1.22	“Valid Claim” means a
                                            claim of a Patent that: (a) has issued and has not expired, lapsed, been cancelled, or abandoned,
                                            or been dedicated to the public, disclaimed, or held unenforceable, invalid, unpatentable,
                                            revoked, or cancelled by a court or administrative agency of competent jurisdiction in an
                                            order or decision from which no appeal has been or can be taken, including through opposition,
                                            reexamination, reissue, disclaimer, inter partes review, post grant review, post grant procedures,
                                            or similar proceedings; or (b) is in a pending patent application that has not been abandoned,
                                            disclaimed, canceled or finally disallowed without the possibility of appeal or refiling.



 






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ARTICLE 2 - LICENSE


 


2.1 License Grant. Subject to Company’s
fulfillment of its payment and other obligations hereunder and CHMC’s reservation of rights below, CHMC hereby grants the following
to Company during the Term, solely within the Territory and solely in the Field of Use:


 


		2.1.1	Exclusive License: An exclusive
                                            license under the Patents to:



 


(a) Develop, make, lease, sell, license,
or otherwise distribute Products; and


 


(b) Practice the Processes solely as
necessary for the exercise of the foregoing rights.


 


		2.1.2	Non-Exclusive License. A non-exclusive
                                            limited license to use and copy the Technology internally solely as necessary for the use
                                            or practice of the Patents under Sub-Paragraph 2.1.1. CHMC will deliver a copy of the Technology
                                            to Company at a time mutually agreed to by the parties and will have no obligation to update
                                            the Technology at any later period.



 


2.2 Reservation of Rights. Notwithstanding
the exclusivity of the license in Sub-Paragraph 2.1.1 above, CHMC reserves on behalf of itself and its Affiliates: (a) all rights,
titles and interests not expressly granted in the license; and (b) the right to practice, have practiced and transfer the Patents
and Technology for research and development purposes, including education, research, teaching, publication and public service. Notwithstanding
the foregoing, in no event shall CHMC’s use or practice, or permit others to use or practice, the Patents or Technology in the
Field of Use for any commercial for profit purpose. For purposes of clarification nothing in this Agreement is intended to or shall be
construed to restrict the ability of CHMC to use, practice or permit others to use or practice the Patents or Technology for any purpose
except as to the Field of Use. Company is obtaining access to the Patents and Technology but not secrecy thereof.


 


2.3 Government Funding; Non-Profit Funding.
The license rights in this Agreement may also be subject to certain rights of the United States federal and/or state or local Government(s)
if the Technology and/or the Patents were created or invented in the course of Government-funded research. Such rights may include, for
example, a royalty-free license to the Government and the requirement that any Product produced for sale in the United States will be
manufactured substantially in the United States. Company acknowledges such rights and agrees to comply and cause its Affiliates, Sublicensees
and agents to comply with all such requirements, including, without limitation, any of those set forth in 35 U.S.C. Section 200 et seq.
and regulations pertaining thereto (or any successor statutes or regulations). Moreover, if the Technology and/or the Patents were created
or invented in the course of research funded by a research grant from a non-Governmental entity, then the license rights may be subject
to the terms of such research grant. If any term of this Agreement fails to conform with the foregoing statutes and regulations or research
grant, the relevant term will be unenforceable and subject to the severability provisions in Paragraph 15.5.


 


2.4 Biological Materials. If the parties
desire that CHMC provide Company any patented or unpatented biological or chemical materials in connection with this Agreement, including
but not limited to, chemical compounds, animal models, cell lines, cells, nucleic acids, receptors or reagents (collectively, and together
with any substance replicated or derived therefrom “Biological Materials”), the parties will execute a separate written
non-exclusive license agreement governing the use of such Biological Materials. Upon the expiration or termination of this Agreement,
Company will, unless otherwise agreed under the non-exclusive license agreement, either return the Biological Materials to CHMC or destroy
them, as instructed by CHMC.


 






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ARTICLE 3 – AFFILIATES; SUBLICENSEES


 


3.1 Affiliates. As a condition to its
receiving the benefits of this Agreement, each Affiliate must first execute and deliver to CHMC a written instrument in form acceptable
to CHMC pursuant to which such Affiliate agrees to be bound by all terms and conditions of this Agreement applicable to Company. Company
hereby unconditionally guarantees the compliance with and performance by each of its Affiliates of all provisions of this Agreement and
will be responsible and jointly and severally liable for all payments due pursuant to this Agreement. A breach of this Agreement by any
of Company’s Affiliates will also be deemed a breach by Company. Company will provide CHMC with an updated list of all Affiliates
from time to time upon CHMC’s request.


 


3.2 Sublicenses. Company may, with the
prior written approval of CHMC on a case by case basis, enter into written agreements with Sublicensees granting them sublicenses of
Company’s rights hereunder to develop, make, lease, sell, license or otherwise distribute Products and practice the Processes consistent
with the terms of this Agreement. Each sublicense will be embodied in a written document which (a) contains provisions at least as favorable
to CHMC for the protection of its rights and limitation of its liability exposure as the terms of this Agreement, and development and
commercialization obligations commensurate in scope as those set forth for Company in this Agreement; (b) contains all rights and obligations
due to CHMC contained in this Agreement; (c) names CHMC as a third party beneficiary who may directly enforce the sublicense agreement
as if it were a party thereto; and (d) does not permit the Sublicensee to grant further sublicenses. Company will provide CHMC unredacted
copies of any executed sublicense agreements and amendments thereto within fifteen (15) days after their execution and an updated list
of all Sublicensees from time to time upon CHMC’s request. Company will promptly collect all royalties and other amounts due from
such Sublicensees and will take appropriate enforcement action against such Sublicensees for any failure to pay or properly calculate
payments. Company will not receive or agree to receive anything of value in lieu of monetary consideration from Sublicensees or amend
such sublicense agreements without CHMC’s prior written consent. All of the terms of this Agreement will apply to each such Sublicensee
to the same extent as they apply to Company. Company hereby guarantees the compliance with and performance by each of its Sublicensees
of all applicable provisions of this Agreement , and any breach of this Agreement by a Sublicensee will be deemed a breach by Company.
No sublicenses will relieve Company of its obligations under Article 4. Any purported sublicenses in violation of this Paragraph will
be void. Affiliates will not have a right to grant any sublicenses.


 


ARTICLE 4 – DUE DILIGENCE 


 


4.1 Company will use commercially reasonable
efforts and will cause any Sublicensees or Affiliates to use best efforts (including, without limitation, by commitment of funding and
personnel consistent therewith), to bring the Products or Processes to market through thorough, vigorous and diligent programs of research,
development, testing, manufacturing, marketing and commercialization and to continue active, diligent efforts for the Products or Processes
throughout the Term. Company will use best efforts to make all necessary Regulatory Filings and obtain all necessary Regulatory Approvals.
CHMC will have the right, in its discretion, to directly or indirectly participate in any NDA prosecution. Company will notify CHMC in
writing within seven (7) days after receiving office notice of any Regulatory Approval. Company will comply with all applicable laws
and regulations in connection with all of the foregoing.


 






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		4.2	In addition, Company will adhere to the following
                                            milestones:



 


		4.2.1	Development
                                            and Commercialization Plans; Reports. A preliminary development and commercialization
                                            plan (“Plan”) will be included herein as Exhibit C. and attached hereto
                                            seting under which Company intends to develop, market, use, sell or otherwise commercialize
                                            the Products and/or Processes. Company will deliver the Plan o CHMC, within 90 days of the
                                            Effective Date. The Plan will set forth each stage of development, the amount of money on
                                            hand and committed to an indication, number and kind of personnel and time budgeted for each
                                            phase of development of each of the Products or Processes over the next year, and summarizing
                                            the development, marketing, manufacturing, sales, and Regulatory Approval progress made since
                                            the previous year and will include sufficient detail to allow CHMC to assess whether Company
                                            has met its obligations under Paragraph 4.1 to use commercially reasonable efforts and its
                                            ability to meet the milestones in Paragraph 4.2.2 below, and will provide similar updated
                                            Plans to CHMC on or before January 1 of each year (“Reports”). Company
                                            will provide CHMC copies of any similar reports provided by Company’s Sublicensees
                                            and such other information as CHMC will reasonably request.



 


		4.2.2	Development and Due Diligence Milestones.
                                            Company will achieve development milestones as described in the time and events below.



		(i)	CDMO kick-off Meeting – 9 months after Effective Date



		(ii)	Pre-IND Meeting – 18 months after
                                            Effective Date



		(iii)	IND filed using Technology – 3 years after Effective Date



		(iv)	First patient dosed using Technology – 1 year after IND Approval



		(v)	First BLA or equivalent using Technology – 3 years after IND Approval



		(vi)	Second BLA or equivalent using Technology – 5 years after IND
                                            Approval



 


		4.3	Milestone
                                            Notices; Failure. Company will inform CHMC in writing before or within three (3) business
                                            days after each milestone deadline whether such milestone has been met. In the event that
                                            Company notifies CHMC that it anticipates non-achievement of a certain Milestone or it in
                                            fact, has not achieved a certain Milestone for any indications that have already entered
                                            development at any stage, then the parties agree to discuss in good faith, for a period of
                                            no more than forty-five (45) days, to discuss amending the Milestones. In the event the parties
                                            cannot mutually agree on such an amendment, CHMC has the option of converting any or
                                            all of such exclusive licenses to nonexclusive licenses with no right to sublicense and no
                                            right to initiate legal proceedings. In the event CHMC converts such exclusive licenses to
                                            nonexclusive licenses, Company continues to be bound by all payment obligations under Article
                                            8. Company’s failure to tomeet any of the milestone payment obligations in Paragraph
                                            8.5 will be grounds for CHMC to terminate this Agreement for material breach. 



 


ARTICLE 5 - PATENT PROSECUTION AND COSTS


 


5.1 Patent Prosecution and Maintenance.
CHMC will have the first and sole right, using in-house or outside legal counsel selected by CHMC, to prepare, file, prosecute, maintain
and extend patents and patent applications in the Patents in its own name in the United States of America and in any other countries
in the Territory, and Company agrees to reimburse CHMC for its legal and administrative costs (including, without limitation, outside
attorneys’ fees, filing fees and maintenance fees) incurred under this Paragraph within thirty (30) days after each receipt of
CHMC’s written statement of such expenses. Without limiting the materiality of any other breaches, Company’s failure to do
so will be a material breach of this Agreement. CHMC will use reasonable efforts to deliver to Company reasonably complete drafts of
all material submissions to patent authorities relating to the Patents, including, without limitation, patent applications and amendments,
and, to the extent feasible, to give Company a reasonable opportunity to comment on such documents prior to their filing. Company will
provide any such comments promptly. CHMC will consider Company’s comments and requests with regard to the preparation, filing,
prosecution and/or maintenance of the Patents in good faith. However, the final decision with respect to such matter will remain with
CHMC. CHMC will also provide Company copies of material documents received from such patent authorities relating to the Patents. If CHMC
notifies Company of its proposal to file a Patent hereunder in any country in the Territory and Company notifies CHMC in writing within
fourteen (14) days thereafter that it does not agree to such filing, then CHMC will have the right to file, prosecute and maintain such
Patent in such country at its own expense, and such Patent will not be included in Company’s license under this Agreement.


 






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5.2 Company’s Election to Prosecute.
In the event that CHMC desires not to remain responsible for the prosecution or maintenance of any Patents, it will provide Company with
sixty (60) days’ written notice of such intended decline of responsibility, and Company may, upon written notice, elect to assume,
at Company’s expense, the responsibilities and obligations to prosecute, and maintain and extend in CHMC’s name the abandoned
Patents in their respective countries. Company will use reasonable efforts to deliver to CHMC reasonably complete drafts of all material
submissions to patent authorities relating to the Patents, including, without limitation, patent applications and amendments, and, to
the extent feasible, to give CHMC a reasonable opportunity to comment on such documents prior to their filing. CHMC will provide any
such comments promptly. Company will consider CHMC’s comments and requests with regard to the preparation, filing, prosecution
and/or maintenance of such abandoned Patents in good faith. However, the final decision with respect to such matter will remain with
Company. Company will also provide CHMC copies of material documents received from such patent authorities relating to the Patents.


 


5.3 Company’s Abandonment. If, after
electing to assume the responsibilities set forth in Paragraph 5.2 above, Company subsequently determines not to prosecute or maintain
such Patents in any country, Company will provide CHMC with sixty (60) days’ written notice (“Abandonment Notice”).
If the Territory includes multiple countries and such determination is made on a country-by-country basis, then upon Company’s
Abandonment Notice to CHMC, Company’s license and other rights hereunder will terminate with respect to such country/countries
and CHMC will have the right but not the obligation to assume responsibility for the prosecution and maintenance in such country/countries
and will be responsible for all expenses associated therewith.


 


ARTICLE 6 - PUBLICATION RIGHTS 


 


6.1 CHMC reserves the right for itself and its
Affiliates and investigators to present, publish or otherwise disseminate the results of its and their research on the inventions claimed
in the Patents and Technology. However, CHMC agrees to submit copies of any abstract or manuscript proposed for written or oral presentation
or publication regarding the inventions claimed in the Patents to Company at least thirty (30) days in advance of the submission or presentation.
If Company does not, within thirty (30) days after receipt of the manuscript, object in writing, CHMC may proceed with the presentation
or publication. However, if Company notifies CHMC in writing within such period that it has a reasonable belief that such presentation
or publication would reveal Company’s own Confidential Information or a patentable invention for which patent applications are
being filed under Article 5, it will provide a written request to CHMC specifically identifying the information giving rise to the belief.
CHMC will consider Company’s request in good faith. If it agrees with Company, it will, as applicable, either remove Company’s
Confidential Information or not publish or present the information so identified by Company until such time as a patent application has
been filed or the expiration of sixty (60) days after the date of submission of the manuscript or abstract to Company, whichever occurs
first. Company will keep all submissions made by CHMC hereunder confidential in accordance with Article 11 until such time as CHMC or
its Affiliates or investigators make the applicable publication or presentation.


 






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ARTICLE 7 – OWNERSHIP; IMPROVEMENTS


 


7.1 Ownership. CHMC is and will remain
the sole owner of the Patents, Technology, CHMC Improvements and Biological Materials, as well as any other current or future patent,
copyright, trade secret, database rights or other intellectual property rights in any of the foregoing in any country. Company agrees
to execute any additional documents and do all things necessary or appropriate, during and after the Term of this Agreement, to vest
and confirm all such rights in CHMC to any of the foregoing and to facilitate the obtaining by CHMC of any desired legal protection for
the same in any countries. Any documents or actions described in the preceding sentence will be prepared, filed or taken at CHMC’s
expense, but Company will sign such documents and otherwise cooperate at no cost to CHMC.


 


7.2 Patent Marking. To the extent commercially
feasible, Company will mark all Products with the number of each issued Patent(s) that cover(s) the Products. Any such marking will be
in conformance with the patent laws and other laws of the country of manufacture, use or sale, as applicable.


 


7.3 Contesting the Patents. To the fullest
extent permitted by law in the countries within the Territory, in the event that Company or its Affiliates contest the validity or enforceability
of any of the Patents granted under the laws of such country, or set up or induce the setting up of any adverse allegations as to the
validity or enforceability thereof, or lend their aid and support of any opposition thereto, then CHMC will have the right to terminate
this Agreement immediately upon written notice to Company, and Company will reimburse CHMC for its costs (including, without limitation,
reasonable attorneys’ fees) of defending any such allegations of invalidity or enforceability.


 


7.4 Notification of Improvements. Each
party agrees to promptly disclose their respective Improvements in writing to the other party after they have first been reduced to practice
and patent applications have been filed on them to the extent lawfully permitted to do so without breaching any restrictions on use or
disclosure owed to third parties, and will promptly advise the other party of the filing and maintenance of any patent or application
on the same.


 


7.5 “CHMC Improvement” means
any patented modification, alteration or improvement of any invention claimed in a Patent and which is conceived of or reduced to practice
by one or more employees or agents (including, without limitation, consultants or contractors) of CHMC after the Effective Date and is
assigned to CHMC, and excluding any Joint Improvements as defined in Section 7.7. CHMC Improvements will not be included in the license
grants set forth in this Agreement. Provided that a CHMC Improvement is not encumbered by an agreement with a third party that would
preclude so adding it, CHMC hereby grants to Company an exclusive option to add CHMC Improvements to the license rights granted in this
Agreement for sixty (60) days after Company has been notified of the existence of each such CHMC Improvement under Paragraph 7.4 (an
“Option Period”). CHMC will notify Company in writing of the option fee, as indicated in section 8.3, and patent costs to be
reimbursed by Company, if any, as determined by CHMC, to add such CHMC Improvement. Company may exercise its option to add such CHMC
Improvement by providing CHMC, within the relevant Option Period, with written notification of Company’s desire to so add the CHMC Improvement
and paying CHMC the option fee and patent costs for each CHMC Improvement so added, in which case, such CHMC Improvement will be subject
to the same restrictions, limitations, warranty disclaimers, and obligations herein as the Patents, including, without limitation, the
payment of Running Royalties.


 






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7.6 “Company Improvement”
means any modification, alteration or improvement of any invention disclosed in Technology or a Patent which is conceived of or reduced
to practice solely by one or more employees or agents (including, without limitation, consultants or contractors) of Company or Affiliates
or Sublicensees. CHMC will automatically have a worldwide, perpetual, sublicenseable, non-exclusive, paid up, royalty-free license to
use any Company Improvements solely for clinical or non-clinical, non-commercial research, testing, educational and patient care purposes.
Company agrees to execute and deliver at no charge any additional documents reasonably requested by CHMC to confirm such non-exclusive
license.


 


7.7 “Joint Improvement” means any
patented modification, alteration or improvement of any invention claimed in a Patent and which is conceived of or reduced to practice
jointly by one or more employees or agents (including, without limitation, consultants or contractors) of CHMC and one or more employees
or agents (including, without limitation, consultants or contractors) of Company or Affiliates or Sublicensees after the Effective Date
and is assigned according to the inventorship obligations of each inventor. Joint Improvements will not be included in the license grants
set forth in this Agreement. Provided that a Joint Improvement is not encumbered by an agreement with a third party that would preclude
so adding it, CHMC hereby grants to Company an exclusive option to add Joint Improvements to the license rights granted in this Agreement
for sixty (60) days after Company has been notified of the existence of each such Joint Improvement under Paragraph 7.4 (an “Option
Period”). CHMC will notify Company in writing of the option fee, as indicated in section 8.3, and patent costs to be reimbursed
by Company, if any, as determined by CHMC, to add Joint Improvement. Company may exercise its option to add such Joint Improvement by
providing CHMC, within the relevant Option Period, with written notification of Company’s desire to so add the CHMC Improvement and paying
CHMC the option fee and patent costs for each Joint Improvement so added, in which case, such Joint Improvement will be subject to the
same restrictions, limitations, warranty disclaimers, and obligations herein as the Patents, including, without limitation, the payment
of Running Royalties.


 


7.8 Compulsory
Licensing. During the Term, CHMC may become aware of Third Parties that are interested in obtaining rights to the Products or Processes
for specific indications not indicated in a Report as defined in Section 4.2.1 (each such specific indication being a “New Indication”).
CHMC will provide notice to Company of any written indications of interest in a New Indication (including, without limitation, the written
notice of interest from, and the name and contact details of, any such Third Party (each an “Interested Third Party”) and the
specified New Indication) within thirty (30) days of receipt of such written indication of interest (a “New Indication Notice”).
Company will then provide written notice to CHMC within thirty (30) days of receipt of a New Indication Notice of its decision regarding
the development of such New Indication.


 


7.8.1 If Company elects to develop
the Products or Processes in respect of the New Indication, the Parties will negotiate commercially reasonable development targets to
be pursued by Company under this Section (the “New Indication Development Period”). If, upon expiration of the New Indication
Development Period, Company has not met the development targets, then the relevant New Indication shall be added to the Excluded Field;


 


7.8.2 If Company elects not to develop
the Products or Processes in respect of the New Indication then:


 


(i) Company may
at its sole discretion elect to enter into good faith negotiations with the relevant Interested Third Party for the grant of a sublicense
under the Products or Processes in respect of the relevant New Indication, and Company shall keep CHMC reasonably informed of such negotiations
with CHMC able to join in discussions with Company and the Interested Third Party at CHMC’s discretion; or


 


(ii) if Company
has not within three (3) months of the New Indication Notice entered into good faith negotiations, such New Indication will be excluded
from the license grant and CHMC will be free to pursue licensing of the Products or Processes within each excluded field to the Interested
Third Party.


 






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ARTICLE 8 - PAYMENTS AND ROYALTIES


 


In consideration of the rights set forth herein,
Company will make the following payments to CHMC:


 


		8.1	Initial License Fee. Upon execution
                                            of this Agreement, Company will pay to CHMC a one-time, non-refundable, non-creditable license
                                            fee (“Initial License Fee”) of Twenty-five Thousand Dollars (US $25,000),
                                            payable within thirty (30) calendar day of the Effective Date.



 


		8.2	Deferred License Fees:



 


		(i)	A deferred license fee of One Hundred
                                            Thousand Dollars (US $100,000) is payable upon Company’s first to occur convertible
                                            debt or equity raise after the Effective Date. At Company’s option, payment of the
                                            accrued patent expenses due as of the Effective Date can be made in the form of that convertible
                                            debt or equity to CHMC with the same terms and conditions as the other investors for that
                                            fund raise event.



 


		(ii)	In addition, separate deferred license
                                            fee of One Hundred Thousand Dollars (US $100,000) is payable upon the one year anniversary
                                            of the Effective Date.



 


		8.3	Improvements License Fees: For each Improvement
                                            that Company elects to include in the License Grant as described in Sections 7.5 and 7.7,
                                            Company shall pay a option fee of Fifty Thousand Dollars (US $50,000) within thirty (30)
                                            calendar days of notifying CHMC that the Company exercises the Option to license such Improvement.



 


		8.4	Patent and Legal Fees. Company will
                                            also pay CHMC for all past patent and legal fees associated with the Patents, totaling $177,104.29
                                            as of the Effective Date. Such payments will be made to CHMC within thirty (30) calendar
                                            days after the Company’s first to occur convertible debt or equity raise following
                                            the Effective Date. At Company’s option, payment of the accrued patent expenses due
                                            as of the Effective Date can be made in the form of that convertible debt or equity to CHMC
                                            with the same terms and conditions as the other investors for that fund raise event. As of
                                            the Effective Date, Company will be responsible for all current and on-going patent expenses
                                            and will reimburse CHMC for such expenses promptly upon receipt of invoice.



 


		8.5	Milestone Payments. Upon completion of each milestone
described below, Company will pay CHMC as follows:



 


		(i)	IND filing of Licensed Product - $100,000
                                            for each licensed product; maximum $500,000



 


		(ii)	BLA or equivalent allowed for Licensed
                                            Product in US or EU - $1,250,000



 


		(iii)	First commercial sale of Licensed Product
                                            in US - $2,000,000



 


		(iv)	First commercial sale of Licensed Product
                                            in EU - $1,500,000



 


		(v)	First Commercial sale of Licensed Product
                                            in Japan - $1,000,000



 


		(vi)	First Commercial sale in ROW - $1,000,000



 


		(vii)	Conclusion of first calendar year in
                                            which aggregate Net Sales of Licensed Product(s) exceed $250,000,000 - $7,500,000



 


		(viii) 	Conclusion of first calendar year
                                            in which aggregate Net Sales of Licensed Product(s) exceed $500,000,000 - $15,000,000



 


		(ix)	Conclusion of first calendar year in
                                            which aggregate Net Sales of Licensed Products(s) exceed $1,000,000,000 - $30,000,000



 






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8.6 Running Royalties. Beginning on first
Net Sale, Company will pay CHMC running royalties (“Running Royalties”) on a quarterly basis a percentage of Net Sales
of Company, its Affiliates, and its Sublicensees for the previous quarter as follows:


 


		(i)	while there exists a Valid Claim:



 


		a.	5% for Products or Processes for P-Particle
                                            VLP Bi-valent vaccine for norovirus and rotavirus,



 


		b.	4% on Products or Processes for Universal
                                            Flu Vaccine(s),



 


		c.	2% on Products or Processes for all other
                                            indications



 


		(ii)	while no Valid Claim exits, 50% of the
                                            applicable running royalty rate as outlined in above Subsction 8.6(i)



 


So long as the quarterly payment is more than
two thousand five hundred dollars ($2,500.00), each payment of Running Royalties will be made within thirty (30) days after the end of
each quarter. If the payment is two thousand five hundred dollars ($2,500.00) or less, then payment can be delayed until the sum of the
amount due reaches two thousand five hundred dollars ($2,500.00). Regardless, within thirty (30) days after the end of each quarter,
Company will provide a report of Net Sales in sufficient detail to permit confirmation of the accuracy of the Running Royalty payment
made, including, without limitation and on a country-by-country basis, the number of Products sold or Processes commercialized, the gross
sales and Net Sales and deductions taken from gross sales by category as set forth in the definition of Net Sales to arrive at the Net
Sales calculation, the Running Royalties payable (in U.S. Dollars), and the method used to calculate the Running Royalties as well as
the exchange rates used, if applicable. If the gross sales or Net Sales per Product or Process varies between customers or payors of
the Products or Processes, Company shall further include details, grouped by the differing gross sales or Net Sales per Product or Process,
as to the number of Products sold or Processes commercialized, the gross sales and Net Sales and deductions taken from gross sales by
category as set forth in the definition of Net Sales to arrive at the Net Sales calculation.


 


		8.6.1	Anti-Stacking Provision. In the
                                            event that Company is legally required to make royalty payments to one or more third parties
                                            whose patent rights dominate the Patent(s) and would therefore be infringed by the exercise
                                            of the license rights granted in Paragraph 2.1, or whose patent rights Company is required
                                            to license to obtain Regulatory Approval to sell Product, Company may reduce Running Royalties
                                            due to CHMC in the same quarterly reporting period by fifty percent(50%), provided, however,
                                            that in no event shall the Running Royalties be reduced below half of the applicable Running
                                            Royalty in Subections 8.6(i) and (ii) in any quarterly reporting period. In order to exercise
                                            its offset rights hereunder, Company must send written notice to CHMC describing the nature
                                            and amount of its payment requirements, the identity of the third party and the applicable
                                            third party patents promptly after first becoming aware of the requirement to make any such
                                            payments. In no event will Company be eligible to reduce the Running Royalties as described
                                            in this Paragraph for any payments required to be made by Company to use any third party
                                            biological research tools.



 


8.7 Consideration other than Monetary.
Company and its Affiliates and Sublicensees will have no right to sell, license or otherwise distribute Products or commercialize Processes
for no consideration or in exchange for non-monetary compensation without CHMC’s prior written consent. Upon any such approved
sale, license or other distribution or disposal other than for monetary consideration or at a discounted price substantially lower than
the customary price, such Product will be deemed to be sold or Process used exclusively for money at the average price during the applicable
reporting period generally achieved in arms’ length transactions for such Product or Process in the country in which such sale,
license or other distribution or disposal occurred when such Product is sold or Process used alone and not with other products (or, in
the absence of such sales or licenses, at the fair market value of the Product or Process).


 






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8.8 Sublicenses. In the event that Company
enters into a sublicense agreement with a Sublicensee, Company will pay to CHMC a percentage of all non-royalty sublicensing revenues
received from said Sublicensee (including, without limitation, license fees, milestone payments, advances, license maintenance fees,
and other payments) as follows:


 


		(i)	Twenty-five percent (25%) for revenue
                                            received prior to first Net Sale of first Licensed Product, or



 


		(ii)	Fifteen percent (15%) for revenue received
                                            after first Net Sales of first Licensed Product but before first Net Sales of second Licensed
                                            Product, or



 


		(iii)	Five percent (5%) for revenue received
                                            after first Net Sales of second Licensed Product.



 


Payments to CHMC with respect to sublicense revenue
and royalties will be due within thirty (30) calendar days after such amounts are received by Company.


 


8.9 Taxes and Other Fees. In addition
to any other amounts due hereunder, Company will pay, without any deduction to its Net Sales, all federal, state, municipal, foreign,
and other governmental excise, sales, use, property, customs, import, value added and other taxes, fees and levies of any nature that
are assessed upon or with respect to the development, manufacture, use, offer, sale, license distribution, export or import of the Technology,
Products or Processes or otherwise arising in connection with this Agreement, other than United States taxes based on CHMC’s income.
If any withholding tax is imposed under the laws of a country or other taxing jurisdiction outside of the United States on any amounts
to be paid to CHMC, such amounts will be increased by the amount of the withholding tax. Company will be solely responsible for and will
pay any and all amounts required in the foreign location to be withheld, charged, deducted, or assessed against such payment amounts
and will promptly furnish CHMC with certificates evidencing payment of such amounts.


 


8.10 Payments; Currency. All payments
under this Agreement will be made by wire transfer as per the following instructions:


 


Bank Name: PNC Bancorp


Bank Address: 201 East Fifth
Street, Cincinnati, OH 45202


 


ABA Number: 041000124


Swift Code (aka BIC Code):
PNCCUS33


 


Account Name: Children’s
Hospital Medical Center


Account Number: 4006905247


 


Attention: Center for Technology
Commercialization, Business Manager


Reference: CHMC REF# LIC210501


 


Each wire transfer will identify the obligation
under this Agreement that the payment satisfies. All payments will be made in U.S. Dollars without set-off for currency conversion. With
respect to Net Sales invoiced or expenses incurred in a currency other than U.S. Dollars, the Net Sales invoiced or expenses incurred
will be converted into the US Dollar equivalent using a conversion rate existing in the United States (as reported in the Wall Street
Journal) on the last working day of the applicable reporting/payment period.


 






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8.11 Unpaid Amounts; Interest; Material Breach.
Any sums which have not been timely paid by Company will accrue interest compounded daily from the original due date of each sum until
the date of actual receipt of payment at the annual rate of ten percent (10%) or the maximum rate allowable by law, whichever is higher.
Without limiting the materiality of any other breaches of this Agreement, Company’s failure to make timely payments under this
Article 8 will be deemed a material breach.


 


8.12 Records; Audit. Company will keep
during the Term and for a period of three (3) years thereafter, full, true and accurate books of accounts and other records containing
all information necessary to ascertain and verify the remuneration payable to CHMC hereunder. During the Term of this Agreement and for
three (3) years thereafter, CHMC will have the right to audit, or have an agent, accountant or other representative, audit such books,
records and all other material documentation of CHMC and its Affiliates and Sublicensees relating to Net Sales and other payment obligations
at reasonable times and upon reasonable notice. Should the audit lead to the discovery of a discrepancy to CHMC’s detriment, Company
will pay the amount of the discrepancy, plus interest, within thirty (30) days of Company’s written notice with the findings of
the inspection. CHMC will pay the full cost of the inspection unless the discrepancy is greater than five percent (5%) to CHMC’s
detriment, in which case Company will pay the reasonable cost charged by such accountant for such inspection at the time of payment of
the discrepancy.


 


8.13 Blocked Payments. If by law, regulation,
or fiscal policy of a particular Government, conversion into United States Dollars or transfer of funds of a convertible currency to
the United States is restricted or forbidden (“Blocked Payments”), Company will give CHMC prompt notice in writing and will
pay the Blocked Payments through such means or methods as are lawful in such country as CHMC may reasonably designate. Failing the designation
by CHMC of such lawful means or methods within thirty (30) days after such notice is given to CHMC, Company will deposit such Blocked
Payments in local currency to the credit of CHMC in a recognized banking institution reasonably selected by Company and identified in
a written notice to CHMC by Company.


 


ARTICLE 9 - INFRINGEMENT


 


9.1 Notification. Each
party will promptly report in writing to the other party during the Term any infringement or suspected infringement in the Territory
of any Patent of which it becomes aware and will provide the other party with all available evidence supporting such infringement or
suspected infringement.


 


9.2 Joint Suit. If CHMC
and Company agree in writing to jointly institute a suit against any third party who has infringed or is suspected of infringing any
of the Patents licensed hereunder within the Field of Use in the Territory, then the suit will be brought in the name of both parties.
The parties will agree in writing on who will control the action and how costs and recoveries will be shared. If the parties agree that
Company will control the action, then CHMC may, if it so desires, be represented by counsel of its own selection and at its own expense.


 


9.3 CHMC Infringement Suit. Absent written
agreement as set forth above, CHMC will have the first and sole right, but not the obligation, at its own expense to initiate an infringement
suit or other appropriate action against any third party who at any time has infringed or is suspected of infringing any of the Patents
licensed hereunder. CHMC will provide Company with an opportunity to make suggestions and comments regarding such action; however, all
final decisions will be made by CHMC in its discretion. CHMC will keep Company promptly informed of the status of any such action. CHMC
may join Company to the suit at its option, provided that CHMC will bear all of Company’s litigation-related expenses and out-of-pocket
expenses, including, without limitation, reasonable attorney fees. Otherwise, Company will offer reasonable assistance to CHMC in connection
with such action at no charge to Company except for the reimbursement of reasonable out-of-pocket expenses in connection with such assistance,
including attorneys’ fees. Any damages, profits, or awards of whatever nature recovered from such action will belong solely to
CHMC.


 






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9.4 Company Infringement Suit. In the
event that CHMC does not, within six (6) months after becoming aware of the infringement, secure cessation of the infringement, enter
suit against the infringer or provide Company with evidence of the pendency of a bona fide negotiation for the acceptance by the infringer
of a sublicense under the Patents, then to the extent that its license rights are then exclusive, Company will have the right at its
own expense to initiate an infringement suit against such infringer if and only to the extent that the infringement is in the Territory
and the Field of Use and adversely and substantially affects Company’s exclusive license rights. Company may join CHMC to the suit,
upon CHMC’s approval which will not be unreasonably withheld. If CHMC is joined, Company will bear all of CHMC’s litigation-related
expenses and out-of-pocket expenses in connection with such assistance, including, without limitation, reasonable attorney fees. Otherwise,
CHMC will offer reasonable assistance to Company at no charge to Company except that Company will reimburse CHMC for all of its reasonable
out-of-pocket expenses, including attorney fees. Company will give CHMC sufficient advance written notice of its intent to initiate or
not initiate any such action and the reasons therefor and will provide CHMC with an opportunity to make suggestions and comments regarding
such action; however, all final decisions will be made by Company in its discretion. Notwithstanding the foregoing, CHMC will also independently
have the right to voluntarily join the suit, in which case CHMC will pay one half of the cost of prosecuting the lawsuit from the date
of joining. Company will keep CHMC promptly informed of the status of any such action. Any damages, profits or awards of whatever nature
recovered from such action will be treated as Net Sales under this Agreement after Company has been compensated for its costs in handling
such action hereunder and also after CHMC has been compensated for its costs in handling such action if CHMC joins the suit. Company
will have no right or authority to settle or otherwise voluntarily dispose of any such action without CHMC’s prior written consent,
not to be unreasonably withheld, except that Company may grant a sublicense to any alleged infringer in accordance with the terms and
conditions of this Agreement relating to sublicenses. Any upfront fees, royalties and other revenues delivered to Company pursuant to
such sublicense will be treated as set forth in Paragraph 8.8.


 


9.5 Abandonment of Suit. In the event
that either party institutes a suit under this Article and then decides to abandon the suit, it will first provide timely written notice
to the other party of its intention to abandon the suit, and the other party, if it wishes, may continue prosecution of such suit, provided
however, that the sharing of expenses and of any recovery in such suit will be agreed upon separately in good faith by the parties taking
into account their respective efforts in the prosecution.


 


9.6 Third Party Suit. In the event that
a third party institutes a suit against Company for infringement, Company will promptly inform CHMC and keep CHMC regularly informed
of the proceedings. In the event that such third party institutes a suit against CHMC or CHMC is joined as a party, CHMC will have the
right to control the defense of the suit.


 


9.7 Declaratory Judgment Actions. In the
event that a declaratory judgment action is brought against Company by a third party alleging invalidity or unenforceability, or non-infringement
of the Patents, CHMC, at its option, will have the right in its discretion within thirty (30) days after receiving notice of the commencement
of such action to intervene and participate at its own expense or to take over sole control of the defense of the action at its own expense.
In any case, the party controlling the defense will provide to the other party each document or a draft thereof pertaining to the declaratory
judgment action, including, but not limited to, each communication with opposing counsel, pleading, discovery requires, or other court
filing, as follows: (a) documents received from the court or opposing counsel will be provided promptly after receipt; and (b) for a
document to be served on opposing counsel or filed in court, a draft of such document will be provided to the non-controlling party sufficiently
in advance of its filing to allow for review and comment by the non-controlling party. The controlling party agrees to consider the non-controlling
party’s comments in good faith but will have the right to make all decisions in its sole discretion.


 






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ARTICLE 10 - WARRANTY DISCLAIMER


 


		10.1	Nothing in this Agreement will be construed
                                            as:



 


		(a)	A warranty or representation by CHMC as
                                            to the validity or scope of any Patent or that any pending patent applications under the
                                            Patents will issue;



 


		(b)	A warranty or representation that anything
                                            made, used, sold or otherwise disposed of under any license granted in this Agreement is
                                            or will be free from infringement of patents, copyrights, trade secrets or other intellectual
                                            property of third parties;



 


		(c)	An obligation of CHMC to bring or prosecute
                                            actions or suits against third parties for infringement;



 


		(d)	Granting by implication, estoppel or otherwise
                                            any licenses under patents of CHMC other than Patents; or



 


		(e)	An obligation to furnish any technology,
                                            technological information or other materials other than as expressly identified herein.



 


10.2 CHMC MAKES NO, AND HAS NOT MADE ANY, REPRESENTATIONS
OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND ASSUMES NO RESPONSIBILITIES OR LIABILITY WHATSOEVER WITH RESPECT TO THE PATENTS,
TECHNOLOGY OR BIOLOGICAL MATERIALS OR THE USE, SALE OR OTHER DISPOSITION BY COMPANY OR ITS AFFILIATES, SUBLICENSEES, VENDEES OR OTHER
AGENTS OR TRANSFEREES OR END USERS OF PRODUCTS OR PROCESSES INCORPORATING OR MADE BY USE OF ANY TECHNOLOGY OR PATENTS LICENSED UNDER
THIS AGREEMENT OR BIOLOGICAL MATERIALS (IF ANY), FURNISHED IN CONNECTION WITH THIS AGREEMENT. THE FOREGOING ARE PROVIDED AS IS, WITHOUT
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED, AND COMPANY WAIVES ALL RIGHTS
TO MAKE ANY CLAIM WHATSOEVER AGAINST CHMC WITH RESPECT TO ANY OF THE FOREGOING. COMPANY SHALL BE SOLELY RESPONSIBLE FOR ALL REPRESENTATIONS
AND WARRANTIES THAT COMPANY OR ITS AGENTS, SUBLICENSEES OR AFFILIATES MAKE TO THIRD PARTIES WITH RESPECT TO ANY OF THE FOREGOING.


 


ARTICLE 11 – PUBLICITY; MARKS; CONFIDENTIALITY


 


11.1 Publicity. Neither party will make
any public press release or similar publicity announcement or disclosure regarding this Agreement without the other party’s prior
written consent. The disclosing party will provide copies of the proposed disclosure reasonably in advance (but in no event less than
fifteen (15) business days) of such release or announcement for the non-disclosing party’s prior review and comment. The non-disclosing
party will provide its comments, if any, on such announcement as soon as practicable. Notwithstanding the foregoing, either party will
be permitted, without the need for consent, to make an objective statement that this Agreement exists, without revealing its terms and
conditions.


 






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11.2 Use of Names, Logos or Symbols. No
rights are granted in or to CHMC’s or its Affiliates’ names, logos, trademarks or service marks (including, without limitation,
the names “Cincinnati Children’s Hospital Medical Center,” “CHMC,” “Cincinnati Children’s Research
Foundation” or “CCRF”), or the physical likeness or names of its employees or investigators or other symbols of CHMC
or its Affiliates for any purpose without its prior written consent, other than as approved under Paragraph 11.1 above.


 


11.3 Confidential Information. For purposes
of this Agreement, Confidential Information means any non-public information or materials of a party hereto which the other party is
provided or has access to hereunder that relate to the transmitting party’s research or business, or the Patents, Technology or
Biological Materials, and which are either identified as confidential at the time of disclosure or should, under the circumstances, reasonably
be expected to be confidential such as test data, samples, data, drawings, trade secrets, draft and final correspondence with the United
States Patent and Trademark Office and other patent authorities, and the terms of this Agreement, but does not include materials or information
that the receiving party can, prior to its proposed use or disclosure, substantiate through written documentation: (a) is explicitly
approved for release by the transmitting party; (b) was already known by the receiving party prior to receiving the information or material
from the transmitting party; (c) was lawfully disclosed to the receiving party by a third party having the right to disclose it without
an obligation of confidentiality; (d) was in the public domain at the time of disclosure or later become part of the public domain through
no fault or breach of obligation by the receiving party, its employees, or agents; or (e) was independently developed by the receiving
party without use of the disclosing party’s Confidential Information.


 


11.4 Confidentiality Obligations. Each
party agrees to maintain such Confidential Information received from the other party in strict confidence, to use it only in a manner
consistent with the purpose for which it was transmitted and to not disclose it to third parties except third parties who are counsel
or who are employees, consultants or permitted contractors or subcontractors of the receiving party who have a need to know, have been
instructed that it is proprietary information and are under binding obligations to maintain its confidentiality pursuant to terms which
are at least as stringent as those set forth herein. Each party agrees to take the same measures to protect the Confidential Information
of the other party that it takes to protect its own information of comparable sensitivity, but in no event less than reasonable care.
All materials transmitted between the parties or accessed hereunder and containing Confidential Information will remain the property
of the transmitting party and will, along with all copies, summaries and other tangible manifestations thereof, be immediately returned
upon termination or expiration of this Agreement or upon earlier reasonable request unless previously destroyed at the transmitting party’s
request. Each party will, upon the other party’s request, provide a written officer’s certificate certifying that it has
so returned or destroyed the other party’s Confidential Information. Each party will be responsible for any breach of confidentiality
hereunder by any of its Affiliates, Sublicensees, consultants, employees, independent contractors. Each party will advise the other immediately
in the event that it learns or has reason to believe that any person discloses or uses or intends to disclose or use such other party’s
Confidential Information and will reasonably cooperate with the other party to prevent or remedy the same.


 


11.5 Required Disclosures. Notwithstanding
the foregoing, CHMC and Company may disclose each other’s Confidential Information to the extent that it is required to be disclosed
by law or regulation or is reasonably required to be disclosed in order to enforce rights under the Agreement, provided that the receiving
party will, if reasonably possible, notify the other party of the intended disclosure in advance, reasonably cooperate with the disclosing
party’s effort to seek a protective order contesting or limiting the disclosure and limit its disclosure to that which is required
for the foregoing purpose. CHMC may also disclose the terms and conditions of this Agreement to the Government and its agents as necessary
in connection with any Government funding related to the Patent rights or Technology.


 






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11.6 Duration of Confidentiality Obligations.
Notwithstanding the expiration or termination of this Agreement, the parties’ respective confidentiality obligations will continue
in effect for ten (10) years after the expiration or termination of this Agreement.


 


11.7 Remedies. The parties each acknowledge
and agree that a breach of this Article 11 may cause irreparable harm to the non-breaching party for which the award of money damages
may be inadequate. The parties therefore agree that in the event of any breach of this provision, the non-breaching party will be entitled
to seek injunctive relief in addition to seeking any other remedy provided in this Agreement or available at law.


 


ARTICLE 12 - TERMINATION


 


12.1 For Convenience. Company may terminate
this Agreement at any time prior to first commercial sale of a Product or Process by providing at least one hundred and eighty (180)
days’ written notice to CHMC.


 


12.2 For Breach.


 


		12.2.1	In the event that Company breaches
                                            any of its material obligations hereunder, CHMC may at its sole option and discretion terminate
                                            this Agreement, provided that CHMC will have first given Company written notice specifying
                                            the nature of the breach and Company will have failed to cure such breach within thirty (30)
                                            days thereafter. If Company has begun to cure such breach and is diligently pursuing its
                                            cure if such breach is curable, but is not capable of being cured within thirty (30) days
                                            of such notice, then CHMC shall not exercise its termination rights for an additional sixty
                                            (60) day period.



 


		12.2.2	Subject to Section 4.3 and Section
                                            12.2.3, n the event that CHMC breaches any of its material obligations hereunder, Company
                                            may, upon written notice, terminate this Agreement, provided that it will have first given
                                            CHMC written notice specifying the nature of the breach and CHMC will have failed to cure
                                            such breach within thirty (30) days thereafter. If CHMC has begun to cure such breach and
                                            is diligently pursuing its cure if such breach is curable, but is not capable of being cured
                                            within thirty (30) days of such notice, then Company shall agree to give CHMC an additional
                                            sixty (60) day period to cure such breach.



 


		12.2.3	In the event Company’s material breach is related to
failure to meet Milestones under Section 4.2.2, Company is entitled to a nonexclusive license under Section 4.3, to continue to develop
indications that have already entered development at any stage or in which Company has invested in developing.



 


12.3 For Company’s Bankruptcy or Insolvency.
CHMC may also terminate this Agreement by written notice to Company upon Company’s (i) becoming insolvent or otherwise unable to
pay its debts as they become due (unless Company cures such condition within thirty (30) days after receipt of written notice of a claim
of insolvency by CHMC); (ii) making a general assignment for the benefit of its creditors; or (iii) becoming the subject of a voluntary or
involuntary petition in bankruptcy or any voluntary or involuntary proceeding relating to receivership, liquidation, or composition
for benefit of creditors under domestic or foreign bankruptcy or insolvency law.


 


12.4 Effect on Sublicenses. Termination
of this Agreement will automatically terminate all sublicenses which may have been granted by Company.


 






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12.5 General Effect of Termination; Survival.
Upon expiration or termination of this Agreement, neither party will be relieved of any obligations incurred prior to such termination,
and the obligations of the parties under any provisions which by their nature are intended to survive any such termination will survive
and continue to be enforceable, including, without limitation, those related to confidentiality, indemnification, limitation of liability,
exclusion of damages and payments then due. Company will provide CHMC with all information and data in its possession or control as of
the termination date that is reasonably necessary for CHMC to continue to pursue the development of Products and Processes, and CHMC
or its agents or licensees will have a right to reference Company’s regulatory filings. Termination or expiration of this Agreement
for any reason will not preclude any party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect
to any breach of this Agreement.


 


ARTICLE 13 – INDEMNIFICATION; INSURANCE;
LIMITATION OF LIABILITY


 


13.1 Indemnification. Company will, at
its sole expense, defend CHMC and its Affiliates, and its and their agents, directors, trustees, officers and employees (or anyone of
them) against all claims, suits, actions, demands, judgments, or investigations (both governmental and non-governmental), and will indemnify,
release and hold them harmless from and against any and all losses, damages, fees, liabilities, penalties or expenses (including, without
limitation, reasonable attorneys’ fees) incurred, assessed or awarded, under any theory of liability, including, without limitation,
tort, warranty or strict liability, arising out of or in connection with (i) the development, manufacture, use, commercialization, packaging,
marketing or sale, lease, license or other distribution or disposition by Company and its Sublicensees and Affiliates or any of their
agents of any Product and/or Process hereunder, (ii) the use by Company or its Sublicensees or Affiliates or any of their agents or transferees
of Technology, Biological Materials or Patents, or the use, sale or other disposition by Company or its Sublicensees or Affiliates or
any of their agents or transferees of Products or Processes; (iii) any representation or warranty made by Company or its Sublicensees
or Affiliates or agents to third parties with respect to the Patents, Technology, Products or Processes; (iv) any claims for death, illness
or personal injury caused by the Products and/or Processes; or (v) any asserted violation by Company or its Sublicensees or Affiliates
or any of their agents of any Export Laws or other applicable laws or regulations. Company also will reimburse CHMC for its expenses,
including, without limitation, reasonable attorneys’ fees, in enforcing this provision.


 


To receive indemnification from Company, CHMC
must: (i) notify the Company promptly of the assertion of any such claims against it (an “Indemnifiable Claim”); provided
that any delay by the CHMC in giving notice to Company of an Indemnifiable Claim will not affect the CHMC’s right to be
indemnified for such Indemnifiable Claim except to the extent that Company is actually prejudiced in its ability to defend against such
Indemnifiable Claim; and, (ii) authorize and permit Company to conduct and exercise control of the defense and disposition of such claims,
provided however, that Company agrees not to enter into any settlement or compromise of any claim or action in a manner that admits fault
or imposes any restrictions or obligations upon an CHMC without that CHMC’s prior written consent, which will not be unreasonably
withheld.


 


13.2 Insurance. Company will, beginning
with the first clinical trial or the first commercial sale or other commercialization of Products or Processes, whichever occurs earlier,
and continuing during the Term, carry workers’ compensation insurance in the amounts statutorily required, and occurrence-based
liability insurance, including products liability, general commercial liability and contractual liability, in an amount sufficient to
cover the liability assumed by Company hereunder, such amount being at least Five Million Dollars $5,000,000 per occurrence and Ten Million
Dollars $10,000,000 annual aggregate. Such policy will name CHMC as an additional insured and require at least fifteen (15) days notice
to CHMC prior to any cancellation or material change. Company will provide CHMC a certificate evidencing such coverages from time to
time upon CHMC’s reasonable request. The amounts of insurance coverage required herein will not be construed as creating any limitation
on Company’s indemnification obligations under this Agreement.


 






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13.3 Exclusion of Damages; Limitation of Liability.
NEITHER CHMC NOR ITS AFFILIATES SHALL BE LIABLE TO ANY PARTY FOR SPECIAL, EXEMPLARY, INDIRECT, CONSEQUENTIAL OR PUNITIVE DAMAGES, WHETHER
IN CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT, THE PATENTS, TECHNOLOGY,
BIOLOGICAL MATERIALS, PRODUCTS OR PROCESSES, INCLUDING BUT NOT LIMITED TO DAMAGES MEASURING LOST PROFITS, GOODWILL OR BUSINESS OPPORTUNITIES,
EVEN IF ADVISED IN ADVANCE OF THE POSSIBILITY OF SUCH DAMAGES.


 


13.4 Limitation of Liability. IN NO EVENT
WILL CHMC’S AND ITS AFFILIATES’ TOTAL AND CUMULATIVE LIABILITY TOGETHER OF ANY KIND, EVEN FOR DIRECT DAMAGES, ARISING OUT
OF OR IN CONNECTION WITH THIS AGREEMENT, THE PATENTS, TECHNOLOGY, BIOLOGICAL MATERIALS, PRODUCTS AND PROCESSES, EXCEED THE TOTAL AMOUNT
OF THE PAYMENTS ACTUALLY RECEIVED BY CHMC.


 


ARTICLE 14 - NOTICES


 


14.1 All notices to be given hereunder will be
in writing and personally delivered or sent by postage pre-paid first class mail , air mail if not domestic (except that payments and
notices of breach or that otherwise materially affect the parties’ rights hereunder must be sent postage pre-paid by international
certified mail, return receipt requested or international Federal Express or other similar reputable international courier or postal
services providing a tracking or return receipt delivery) addressed to the respective parties at the following addresses, or such other
address and/or individual as a party will designate in writing for such purpose:


 


14.2 Notices and other communications to Company
concerning this Agreement will be addressed to:


 


Erin Henderson___________________


Chief Business Officer______________


201 E Fiftth Street, Suite
1900________________


Cincinnati, OH 45202_________________


ehenderson@bluewatervaccines.com


 


Invoices related to fees
or patent expenses shall be addressed to:


 


Accounts Payable___________________


201 E Fiftth Street, Suite
1900________________


Cincinnati, OH 45202_________________


Email: ap@bluewatervaccines.com___________________


 


14.3 Notices and other communications to CHMC
concerning this Agreement will be addressed to:


 


Cincinnati Children’s
Hospital Medical Center


Legal Department


3333 Burnet Avenue, Mail Location
7032


Cincinnati, Ohio 45229-3039,
U.S.A.


 


Cincinnati Children’s
Hospital Medical Center


Innovation Ventures


3333 Burnet Avenue, Mail Location
7032


Cincinnati, Ohio 45229-3039,
U.S.A.


Fax: 513/636-8453


ATTN: Director Portfolio Management


 






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ARTICLE 15 –
MISCELLANEOUS


 


15.1 Assignment. This is a personal contract
between CHMC and Company. CHMC has investigated Company, its officers and has selected Company because of the unique qualifications of
its business, reputation, competitive posture, and the character of its officers and principals. Neither this Agreement nor any of the
rights or obligations hereunder may be assigned or otherwise transferred in whole or in part by Company, whether by contract, change
of control, operation of law or otherwise, without the prior written consent of CHMC, and any attempt to so transfer without such written
consent will be void and of no effect. Subject to the foregoing, this Agreement will be binding upon and inure to the benefit of the
parties, their legal representatives, heirs and assigns.


 


15.2 Export Laws. It is understood that
CHMC is subject to United States laws and regulations controlling the export of technical data, computer software, laboratory prototypes
and other commodities, and that its obligations hereunder are contingent on compliance with all applicable United States export laws
and regulations (“Export Laws”). The transfer of certain technical data and/or commodities (which may include the
Technology and Biological Materials) may require a license from the cognizant agency of the United States Government and/or written assurances
by Company that Company and its Affiliates and Sublicensees will not export data or commodities to certain foreign countries without
prior approval of such agency. CHMC neither represents nor warrants that a license will not be required nor that, if required, it will
be issued. In any event, Company specifically agrees not to export or re-export any information and/or technical data and/or products
in violation of any applicable Government laws and/or regulations. Company agrees to provide notice to and obtain written approval from
the CHMC prior to transferring, directly or indirectly, anything enumerated on the Commerce Control List or United States Munitions List.
CHMC reserves the right to not accept the item, software, or technology/technical data. Any such decision will not result in breach of
contract. Company does not need to provide notice to or obtain written approval from CHMC prior to transferring anything classified as
EAR99 or exempt from export control regulations.


 


15.3 Governing Law; Venue. This Agreement
and all matters related thereto will be construed and interpreted under and governed by the laws of the State of Ohio (other than its
conflicts of laws provisions) and the federal patent, trademark, copyright and other applicable federal laws of the United States of
America, and CHMC and Company hereby submit to the exclusive jurisdiction of the federal and state courts located in Hamilton County,
Ohio for the resolution of any dispute, claim or legal proceeding arising out of or related to this Agreement, waive any objection to
such jurisdiction on the grounds of venue, forum non conveniens, or similar ground, and agree that any such dispute, claim or proceeding
will be brought exclusively in one of those courts.


 


15.4 Force Majeure. Neither party will
be liable for any default or delay in the performance of its obligations under this Agreement to the extent that such default or delay
is caused, directly or indirectly, by acts of God, civil disturbance, war, fires, acts or orders of any Government agency or official,
other than Company’s failure to obtain Regulatory Approvals, natural catastrophes, or any other circumstances beyond such party’s
reasonable control. In any such event, the non-performing party will be excused from any further performance or observance of the obligation
so affected only for as long as such circumstances prevail and such party continues to use commercially reasonable efforts to recommence
performance or observance as soon as practicable. Any party whose performance is delayed or prevented by any cause or condition within
the purview of this Paragraph will promptly notify the other party thereof, the anticipated duration of the non-performance, and the
action(s) being taken to overcome or mitigate the delay or failure to perform. Notwithstanding the foregoing, under no circumstances
will any delay or nonperformance be excused or forgiven (a) if the cause of the nonperformance could have been prevented or avoided by
the exercise of reasonable diligence; (b) if the party whose performance is delayed or prevented fails to use reasonable diligence to
promptly overcome and mitigate the delay or failure to perform; or (c) if the nonperformance is caused by the negligence, intentional
conduct or misconduct of the nonperforming party. The parties understand and agree that Governmental acts, orders or restrictions
do not constitute excusing events hereunder if such acts, orders or restrictions are issued due to either party’s alleged failure to
conform to applicable laws, regulations or other governmental requirements. If the delay or non-performance lasts for more than 180 days
in any 360 day period, then the non-affected party may terminate this Agreement upon written notice with respect to the countries in
the Territory affected by the delay or non-performance.


 






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15.5 Severability. The provisions set
forth in this Agreement will be considered to be severable and independent of each other. In the event that any provision of this Agreement
will be determined to be unenforceable by a court of competent jurisdiction with respect to any country in the Territory, such determination
will not be deemed to affect the enforceability of any other provision and the parties agree that any court making such a determination
is hereby requested and empowered to modify such provision and to substitute for such unenforceable provision such limitation or provision
of a maximum scope as the court then deems reasonable and judicially enforceable and the parties agree that such substitute provision
will be as enforceable in said country as if set forth initially in this Agreement. Any such substitute provision will be applicable
only in the country in which the original provision was determined to be unenforceable. However, in the event that such court declines
to modify such provisions, then the parties will in good faith negotiate a modification to the provision to the minimum extent necessary
to render it valid and enforceable in conformity with the parties’ intent as manifested herein.


 


15.6 Headings; Jointly Drafted Agreement.
Headings used herein are for reference purposes only and neither limit nor amplify the terms and conditions herein. For purposes of construction,
this Agreement will be deemed to have been jointly drafted by the parties and their counsel, and the rule of construction of contracts
that ambiguities are construed against the drafting party will not be applied against either party.


 


15.7 Independent Contractors. The relationship
between CHMC and Company created by this Agreement is solely that of independent contractors. This Agreement does not create any agency,
distributorship, employee-employer, partnership, joint venture or similar business relationship between the parties. No party is a legal
representative of another party, and no party has the right to assume or create any obligation, representation, warranty or guarantee,
express or implied, on behalf of another party for any purpose whatsoever. Each party will use its own discretion and will have complete
and authoritative control over its employees and the details of performing its obligations under this Agreement.


 


15.8 Entire Agreement; Amendment. This
Agreement, together with its Exhibits, which are hereby incorporated by reference, contains the full understanding of the parties with
respect to the subject matter hereof and supersedes all prior understandings and writings relating thereto. It may not be modified or
amended except by a writing signed by both parties identified as an amendment to this Agreement.


 


15.9 Waiver. The waiver by either party
of any right, claim, or breach by the other party must be in written form and signed by the party against whom the waiver is charged,
and it will not be construed as a waiver of any succeeding right, claim, or breach.


 


15.10 Counterparts. This Agreement may
be executed in separate counterparts, each of which so executed and delivered will constitute an original, but all such counterparts
will together constitute one and the same instrument. Any such counterpart may comprise one or more duplicates or duplicate signature
pages any of which may be executed by less than all of the parties provided that each party executes at least one such duplicate or duplicate
signature page.


 




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IN WITNESS WHEREOF, the parties
hereto have caused this Agreement to be executed by their properly and duly authorized officers or representatives as of the Effective
Date.


 





	CHILDREN’S HOSPITAL	 	COMPANY
	MEDICAL CENTER 	 	 
	 	 	 
	 	 	 
	Signature	 	Signature
	 	 	 
	Abram S. Gordon	 	
	Printed Name	 	Printed Name
	 	 	 
	Vice President,
    Innovation Ventures	 	
	Title	 	Title
	 	 	 


 




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Exhibit A


Company’s Affiliates


 


 


 


 


 


 




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Exhibit B


Patents


 


Case 2008-1213:


- U.S. Patent 8,486,421, entitled “Antigen-Norovirus P-Domain
Monomers and Dimers, Antigen-Norovirus P-Particle Molecules, and Methods of Their Making and Use”, filed on Jan. 9, 2010, issued
on Jul. 16, 2013, with priority dates of Jun. 9, 2009 (Provisional application No. 61/185.564) and Jul. 10, 2009 (provisional application
No. 61/224,696)


- U.S. Patent 9,096,644, entitled “Antigen-Norovirus P-Domain
Monomers and Dimers, Antigen-Norovirus P-Particle Molecules, and Methods of Their Making and Use”, filed on Jun. 9, 2009, with
a priority date of Jul. 10, 2009.


- European Patent 2440582, entitled “Antigen-Norovirus P-Domain
Monomers and Dimers, Antigen-Norovirus P-Particle Molecules, and Methods of Their Making and Use”, filed on Jun. 9, 2010, issued
on Nov. 7, 2018, with priority dates of Jun 9, 2009 (Provisional application No. 61/185.564) and Jul. 10, 2009 (provisional application
No. 61/224,696) (validated in France, Germany, Italy, UK)


- Japan Patent 5894528, entitled “Antigen-Norovirus P-Domain
Monomers and Dimers, Antigen-Norovirus P-Particle Molecules, and Methods of Their Making and Use”, filed on Jun. 9, 2010, issued
on Mar. 4, 2016, with priority dates of Jun 9, 2009 (Provisional application No. 61/185.564) and Jul. 10, 2009 (provisional application
No. 61/224,696)


 


Case 2017-0103:


- U.S. Patent Application No. 16/489,095, entitled “Norovirus
S Particle Based Vaccines and Methods of Making and Using Same,” filed on Aug. 27, 2019, with priority date Mar. 28, 2017 (Provisional
Application No. 62/477,481)


- Euopean Patent Application No. 18777340.3, entitled “Norovirus
S Particle Based Vaccines and Methods of Making and Using Same,” filed on Sept. 12, 2019, with priority date Mar. 28, 2017 (Provisional
Application No. 62/477,481)


- Japan Patent Application No. 2019-546799, entitled “Norovirus
S Particle Based Vaccines and Methods of Making and Using Same,” filed on Aug. 27, 2019, with priority date Mar. 28, 2017 (Provisional
Application No. 62/477,481)


- China Patent Application No. 201880017019.3, entitled “Norovirus
S Particle Based Vaccines and Methods of Making and Using Same,” filed on Sept. 9, 2019, with priority date Mar. 28, 2017 (Provisional
Application No. 62/477,481)


- Hong Kong Patent Application No. 62020005692.2, entitled “Norovirus
S Particle Based Vaccines and Methods of Making and Using Same,” filed on April 13, 2020, with priority date Mar. 28, 2017 (Provisional
Application No. 62/477,481)


 


Case 2020-1205


- U.S. Provisional Patent Application No. 63/149,742, filed on Feb.
16, 2021, and U.S. Provisional Patent Application No. 63/162,369, filed on Mar. 17, 2021, both entitled “S60-HA1 pseudovirus nanoparticles
as a new influenza vaccine tactic and candidate”.


 


Case 2012-0113


- US Patent No 9,562,077, entitled “Protein Complex System for
Increased Immunogenicity and Functionality, and Methods Making and Use”, filed on Mar. 14, 2013, with priority date July 11, 2012
(Provisional Application No. 61/670,288).


 




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Exhibit C


Development and Commercialization Plan


 


 


 


 


 






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