Exhibit
10.11


 


PUBLIC
HEALTH SERVICE


 


PATENT
LICENSE AGREEMENT – EXCLUSIVE


 


This
Agreement is based on the model Patent License Exclusive Agreement adopted by the U.S. Public Health Service (“PHS”)
Technology Transfer Policy Board for use by components of the National Institutes of Health (“NIH”), the Centers for
Disease Control and Prevention (“CDC”), and the Food and Drug Administration (“FDA”), which are
agencies of the PHS within the Department of Health and Human Services (“HHS”).


 


This
Cover Page identifies the Parties to this Agreement:


 


The
U.S. Department of Health and Human Services, as represented by


The
U.S. Department of Health and Human Services, as represented by


National
Eye Institute


an
Institute or Center (hereinafter referred to as the “IC”) of the


NIH


 


and


 


Connectyx
Technologies Holdings Group


hereinafter
referred to as the “Licensee”,


having
offices at 1825 NW Corporate Boulevard, Suite 110, Boco Raton, FL 33431,


created
and operating under the laws of Florida.


Tax
ID No.: 26-1412177


 




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For
the IC internal use only:


 


License
Number: L-088-2021-0


 


License
Application Number: A-488-2020


 


Serial
Number(s) of Licensed Patent(s) or Patent Application(s):


 


HHS
Ref. No. E-227-2018-0


Entitled:
“Druggable Target to treat Retinal Degeneration”


Inventors:
Kapil Bharti, et. al


 


		I.	U.S.
                                            Provisional Patent Application No. 62/899,899 filed 13 September 2019; HHS Ref No.
                                            E-227-2018- 0-US-01



 


		II.	PCT
                                            Application No. PCT/US2020/050540 filed 11 September 2020; HHS Ref. No. E-227-2018-0-
                                            PCT-02



 


Cooperative
Research and Development Agreement (CRADA) Number (if a subject invention): NA


 


Additional
Remarks: None


 


Public
Benefit(s): Development of ocular metformin formulation for the treatment of retinal degenerative diseases.


 


This
Patent License Agreement, hereinafter referred to as the “Agreement”, consists of this Cover Page, an attached Agreement,
a Signature Page, Appendix A (List of Patent(s) or Patent Application(s)), Appendix B (Fields of Use and Territory), Appendix C (Royalties),
Appendix D (Benchmarks and Performance), Appendix E (Commercial Development Plan), Appendix F (Example Royalty Report), and Appendix
G (Royalty Payment Options).


 




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The
IC and the Licensee agree as follows:


 


	1.	BACKGROUND



 


		1.1	In
                                            the course of conducting biomedical and behavioral research, the IC investigators made
                                            inventions that may have commercial applicability.



 


		1.2	By
                                            assignment of rights from IC employees and other inventors, HHS, on behalf of
                                            the Government, owns intellectual property rights claimed in any United States or
                                            foreign patent applications or patents corresponding to the assigned inventions. HHS
                                            also owns any tangible embodiments of these inventions actually reduced to practice by the
                                            IC.



 


		1.3	The
                                            Secretary of HHS has delegated to the IC the authority to enter into this Agreement
                                            for the licensing of rights to these inventions.



 


		1.4	The
                                            IC desires to transfer these inventions to the private sector through commercialization
                                            licenses to facilitate the commercial development of products and processes for public use
                                            and benefit.



 


		1.5	The
                                            Licensee desires to acquire commercialization rights to certain of these inventions
                                            in order to develop processes, methods, or marketable products for public use and benefit.



 


	2.	DEFINITIONS



 


		2.1	“Affiliate(s)”
                                            means a corporation or other business entity, which directly or indirectly is controlled
                                            by or controls, or is under common control with the Licensee. For this purpose, the
                                            term “control” shall mean ownership of more than fifty percent (50%) of the voting
                                            stock or other ownership interest of the corporation or other business entity, or the power
                                            to elect or appoint more than fifty percent (50%) of the members of the governing body of
                                            the corporation or other business entity.



 


		2.2	“Benchmarks”
                                            mean the performance milestones that are set forth in Appendix D.



 


		2.3	“Commercial
                                            Development Plan” means the written commercialization plan attached as Appendix
                                            E, submitted to the IC by the Licensee that describes plans for development
                                            of the Licensed Products or Licensed Processes within the scope of the Licensed
                                            Patent Rights and the Licensed Field(s) of Use under the terms of this Agreement
                                            and achievement of “practical application”, as defined in 35 U.S.C, §
                                            201(f), of Licensed Products or Licensed Processes under the Licensed Patent
                                            Rights.



 


		2.4	“Commercial
                                            Purpose” means the sale, lease, license, distribution in lieu of purchase, or any
                                            other transfer of the Licensed Products, excluding transfers to contractors or non-profit
                                            collaborators for internal evaluation or internal research. Commercial Purpose shall
                                            also include uses of the Licensed Products to perform contract research, to screen
                                            libraries, to produce or manufacture products for general sale, or to conduct activities
                                            that result in any direct or indirect sale, lease, license, or transfer of the Licensed
                                            Products.



 


		2.5	“CRADA”
                                            means a Cooperative Research and Development Agreement.



 


		2.6	“Effective
                                            Date” means, provided that all conditions are fulfilled under paragraph 13.1(a-c)
                                            for this Agreement taking effect and the authorized signatories of all Parties
                                            to this Agreement have signed, the date of the last signatory’s signature
                                            to this Agreement.



 




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		2.7	“FDA”
                                            means the United States Food and Drug Administration.



 


		2.8	“First
                                            Commercial Sale” means the initial transfer by or on behalf of the Licensee
                                            or its sublicensees of the Licensed Products or the initial practice of a Licensed
                                            Process by or on behalf of the Licensee or its sublicensees in exchange for cash
                                            or some equivalent to which value can be assigned for the purpose of determining Net Sales.



 


		2.9	“Foreign
                                            Regulatory Authority” means in a respective country or jurisdiction, an entity
                                            holding corresponding authority as the United States Food and Drug Administration, to regulate
                                            drugs and/or medical treatment in the country or jurisdiction, including but not limited
                                            to:



 


		(a)	European
                                            Medicines Agency (“EMA”) in the European Union



 


		(b)	Department
                                            of Health in Canada



 


		(c)	Ministry
                                            of Health, Labor, and Welfare in Japan



 


		(d)	Therapeutic
                                            Goods Administration in Australia



 


		(e)	National
                                            Medical Products Administration in China, and



 


		(f)	The
                                            Ministry of Food and Drug Safety in South Korea.



 


		2.10	“Government”
                                            means the Government of the United States of America.



 


		2.11	“Licensed
                                            Fields of Use” means the fields of use identified in Appendix B.



 


		2.12	“Licensed
                                            Patent Rights” shall mean:



 


		(a)	Patent
                                            applications (including provisional patent applications and PCT patent applications) or patents
                                            listed in Appendix A, all divisions and continuations of these applications, all patents
                                            issuing from these applications, divisions, and continuations, and any reissues, reexaminations,
                                            and extensions of these patents;



 


		(b)	to
                                            the extent that the following contain one or more claims directed to the invention or inventions
                                            disclosed in 2.12(a):



 


		(i)	continuations-in-part
                                            of 2.12(a);



 


		(ii)	all
                                            divisions and continuations of these continuations-in-part;



 


		(iii)	all
                                            patents issuing from these continuations-in-part, divisions, and continuations;



 


		(iv)	priority
                                            patent application(s) of 2.12(a); and



 


		(v)	any
                                            reissues, reexaminations, and extensions of these patents;



 




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		(c)	to
                                            the extent that the following contain one or more claims directed to the invention or inventions
                                            disclosed in 2.12(a): all counterpart foreign and U.S. patent applications and patents to
                                            2.12(a) and 2.12(b), including those listed in Appendix A; and



 


		(d)	Licensed
                                            Patent Rights shall not include 2.12(b) or 2.12(c) to the extent that they contain
                                            one or more claims directed to new matter which is not the subject matter disclosed in 2.12(a).



 


		2.13	“Licensed
                                            Processes” means processes to make or use Licensed Products, in the course
                                            of being practiced, would be within the scope of one or more claims of the Licensed Patent
                                            Rights that have not been held unpatentable, invalid or unenforceable by an unappealed
                                            or unappealable judgment of a court of competent jurisdiction.



 


		2.14	“Licensed
                                            Products” means any direct ocular administered formulations of metformin -including
                                            injections to the eye, eye drops and other topical formulations which, in the course of manufacture,
                                            use, sale, or importation, would be within the scope of one or more claims of the Licensed
                                            Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed
                                            or unappealable judgment of a court of competent jurisdiction.



 


		2.15	“Licensed
                                            Territory” means the geographical area identified in Appendix B.



 


		2.16	“Net
                                            Sales” means the total gross receipts for sales of Licensed Products or
                                            practice of Licensed Processes by or on behalf of the Licensee or its sublicensees,
                                            and from leasing, renting, or otherwise making the Licensed Products available to
                                            others without sale or other dispositions, whether invoiced or not, less returns and allowances,
                                            packing costs, insurance costs, freight out, taxes or excise duties imposed on the transaction
                                            (if separately invoiced), and wholesaler and cash discounts in amounts customary in the trade
                                            to the extent actually granted. No deductions shall be made for commissions paid to individuals,
                                            whether they are with independent sales agencies or regularly employed by the Licensee,
                                            or sublicensees, and on its payroll, or for the cost of collections.



 


		2.17	“Phase
                                            1 Clinical Study” means the initial introduction of an investigational new drug,
                                            biologic into humans, the principal purpose of which is to determine the metabolism and pharmacologic
                                            actions in humans, the side effects, doses, and, if possible, to gain early evidence on effectiveness,
                                            in compliance with 21 C.F.R. §312(a) or foreign equivalent.



 


		2.18	“Phase
                                            2 Clinical Study” means controlled human clinical studies conducted to evaluate
                                            the effectiveness of a drug, biologic, for a particular disease indication or indications
                                            in patients with the disease or condition under study and to determine the common short-term
                                            side effects and risks associated in compliance with 21 C.F.R. §312(b) or foreign equivalent,
                                            and shall include any clinical study that leads to a conditional regulatory approval, that
                                            is followed by a confirmatory Phase 3 Clinical Study.



 


		2.19	“Phase
                                            3 Clinical Study” means expanded controlled and uncontrolled human clinical trials
                                            pursuant to a randomized study with endpoints agreed upon by FDA, or Foreign Regulatory
                                            Authority, for regulatory approval performed after Phase 2 Clinical Study evidence
                                            suggesting effectiveness of a drug, or biologic has been obtained, and is intended to gather
                                            additional information about effectiveness and safety that is needed to evaluate the overall
                                            benefit-risk relationship to provide an adequate basis for regulatory approval and physician
                                            labeling, in compliance with 21 C.F.R. §312 or foreign equivalent, and shall include
                                            a confirmatory study that is conducted following conditional regulatory approval.



 




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		2.20	“Practical
                                            Application” means to manufacture in the case of a composition or product, to practice
                                            in the case of a process or method, or to operate in the case of a machine or system; and
                                            in each case, under these conditions as to establish that the invention is being utilized
                                            and that its benefits are to the extent permitted by law or Government regulations
                                            available to the public on reasonable terms.



 


		2.21	“Research
                                            License” means a nontransferable, nonexclusive license to make and to use the Licensed
                                            Products or the Licensed Processes as defined by the Licensed Patent Rights
                                            for purposes of internal research use only and not for purposes of commercial manufacture
                                            or distribution or in lieu of purchase.



 


		2.22	“Third
                                            Party Contractor(s)” means a third-party organization, acting with, on behalf and
                                            for the benefit of Licensee limited to the development of the Licensed Products
                                            for consideration.



 


	3.	GRANT
                                            OF RIGHTS



 


		3.1	The
                                            IC hereby grants and the Licensee accepts, subject to the terms and conditions
                                            of this Agreement, an exclusive license under the Licensed Patent Rights in
                                            the Licensed Territory to make and have made, to use and have used, to sell and have
                                            sold, to offer to sell, and to import any Licensed Products in the Licensed Fields
                                            of Use and to practice and have practiced any Licensed Process(es) in the Licensed
                                            Fields of Use.



 


		3.2	This
                                            Agreement confers no license or rights by implication, estoppel, or otherwise under
                                            any patent applications or patents of the IC other than the Licensed Patent Rights
                                            regardless of whether these patents are dominant or subordinate to the Licensed Patent
                                            Rights.



 


	4.	SUBLICENSING



 


		4.1	Subject
                                            to the terms and conditions of this Agreement, including Paragraphs 4.2-4.5, the IC
                                            hereby grants Licensee the right to grant sublicenses.






 


		4.2	Upon
                                            written approval, which shall include prior review of any sublicense agreement by the IC
                                            and which shall not be unreasonably withheld, the Licensee may enter into sublicensing
                                            agreements that grant rights under the Licensed Patent Rights, provided that the Licensed
                                            Patent Rights are sublicensed together with other patent rights, or proprietary technology
                                            that is owned or controlled by Licensee.



 


		4.3	The
                                            Licensee agrees that any sublicenses granted by it shall provide that the obligations
                                            to the IC of Paragraphs 5.1-5.4, 8.1, 10.1, 10.2, 12.5, and 13.9-13.11 of this Agreement
                                            shall be binding upon the sublicensee as if it were a party to this Agreement.
                                            The Licensee further agrees to attach copies of these Paragraphs to all sublicense
                                            agreements.



 


		4.4	Any
                                            sublicenses granted by the Licensee shall provide for the termination of the sublicense,
                                            or the conversion to a license directly between the sublicensees and the IC, at the
                                            option of the sublicensee, upon termination of this Agreement under Article 13. This
                                            conversion is subject to the IC approval and contingent upon acceptance by the sublicensee
                                            of the remaining provisions of this Agreement.



 


		4.5	The
                                            Licensee agrees to forward to the IC a complete copy of each fully executed
                                            sublicense agreement postmarked within thirty (30) days of the execution of the agreement.
                                            To the extent permitted by law, the IC agrees to maintain each sublicense agreement
                                            in confidence.



 




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		5.	STATUTORY
                                            AND NIH REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS



 


		5.1	(a)
                                                                                                                                                                                                                                    The IC reserves on behalf of the Government an irrevocable, nonexclusive, nontransferable, royalty-free license for
                                                                                                                                                                                                                                    the practice of all inventions licensed under the Licensed Patent Rights throughout the world by or on behalf of the Government
                                                                                                                                                                                                                                    and on behalf of any foreign government or international organization pursuant to any existing or future treaty or agreement to
                                                                                                                                                                                                                                    which the Government is a signatory. Prior to the First Commercial Sale and upon IC’s request, the Licensee
                                                                                                                                                                                                                                    agrees to provide the IC with reasonable quantities of the Licensed Products or materials made through the Licensed
                                                                                                                                                                                                                                    Processes for IC’s research purposes only;



 


(b)
in the event that the Licensed Patent Rights are Subject Inventions made under CRADA, the Licensee grants to
the Government, pursuant to 15 U.S.C. §3710a(b)(1)(A), a nonexclusive, nontransferable, irrevocable, paid-up
license to practice the Licensed Patent Rights or have the Licensed Patent Rights practiced throughout the world by or
on behalf of the Government. In the exercise of this license, the Government shall not publicly disclose trade secrets
or commercial or financial information that is privileged or confidential within the meaning of 5 U.S.C. §552(b)(4) or
which would be considered as such if it had been obtained from a non-Federal party. Prior to the First Commercial Sale and
upon IC’s request, the Licensee agrees to provide the IC with reasonable quantities of the Licensed
Products or materials made through the Licensed Processes for IC’s research purposes only.


 


		5.2	The
                                            Licensee agrees that products used or sold in the United States embodying the Licensed
                                            Products or produced through use of the Licensed Processes shall be manufactured
                                            substantially in the United States, unless a written waiver is obtained in advance from the
                                            IC



 


		5.3	The
                                            Licensee acknowledges that the IC may enter into future CRADAs under
                                            the Federal Technology Transfer Act of 1986 that relate to the subject matter of this
                                            Agreement. The Licensee agrees not to unreasonably deny requests for a Research
                                            License from future collaborators with the IC when acquiring these rights is necessary
                                            in order to make a CRADA project feasible. The Licensee may request an opportunity
                                            to join as a party to the proposed CRADA.



 


		5.4	(a)
                                                                                                                                                                                                                                    In addition to the reserved license of Paragraph 5.1, the IC reserves the right to grant Research Licenses directly or
                                                                                                                                                                                                                                    to require the Licensee to grant Research Licenses on reasonable terms. The purpose of these Research Licenses
                                                                                                                                                                                                                                    is to encourage basic research, whether conducted at an academic or corporate facility. In order to safeguard the Licensed Patent
                                                                                                                                                                                                                                    Rights, however, the IC shall consult with the Licensee before granting to commercial entities a Research
                                                                                                                                                                                                                                    License or providing to them research samples of materials made through the Licensed Processes; and,



 


(b)
in exceptional circumstances, and in the event that the Licensed Patent Rights are Subject Inventions made under a CRADA,
the Government, pursuant to 15 U.S.C. §3710a(b)(1)(B), retains the right to require the Licensee to grant
to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense to use the Licensed Patent Rights in
the Licensed Field of Use on terms that are reasonable under the circumstances, or if the Licensee fails to grant this
license, the Government retains the right to grant the license itself. The exercise of these rights by the Government shall
only be in exceptional circumstances and only if the Government determines:


 


		(i)	the
                                            action is necessary to meet health or safety needs that are not reasonably satisfied by the
                                            Licensee;



 




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		(ii)	the
                                            action is necessary to meet requirements for public use specified by Federal regulations,
                                            and these requirements are not reasonably satisfied by the Licensee; or



 


		(iii)	the
                                            Licensee has failed to comply with an agreement containing provisions described in
                                            15 U.S.C. §3710a(c)(4)(B); and



 


(c)
the determination made by the Government under this Paragraph 5.4 is subject to administrative appeal and judicial review
under 35 U.S.C. §203(b).


 


	6.	ROYALTIES
                                            AND REIMBURSEMENT



 


		6.1	The
                                            Licensee agrees to pay the IC a noncreditable, nonrefundable license issue
                                            royalty as set forth in Appendix C.



 


		6.2	The
                                            Licensee agrees to pay the IC a nonrefundable annual royalty as set forth in
                                            Appendix C.



 


		6.3	The
                                            Licensee agrees to pay the IC earned royalties as set forth in Appendix C.



 


		6.4	The
                                            Licensee agrees to pay the IC benchmark royalties as set forth in Appendix
                                            C.



 


		6.5	The
                                            Licensee agrees to pay the IC sublicensing royalties as set forth in Appendix
                                            C.



 


		6.6	A
                                            patent or patent application licensed under this Agreement shall cease to fall within
                                            the Licensed Patent Rights for the purpose of computing earned royalty payments in
                                            any given country on the earliest of the dates that:



 


		(a)	the
                                            application has been abandoned and not continued;



 


		(b)	the
                                            patent expires or irrevocably lapses, or



 


		(c)	the
                                            patent has been held to be invalid or unenforceable by an unappealed or unappealable decision
                                            of a court of competent jurisdiction or administrative agency.



 


		6.7	No
                                            multiple royalties shall be payable because any Licensed Products or Licensed Processes
                                            are covered by more than one of the Licensed Patent Rights.



 


		6.8	On
                                            sales of the Licensed Products by the Licensee to sublicensees or on sales
                                            made in other than an arm’s-length transaction, the value of the Net Sales attributed
                                            under this Article 6 to this transaction shall be that which would have been received in
                                            an arm’s-length transaction, based on sales of like quantity and quality products on
                                            or about the time of this transaction.



 




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		6.9	Licensee,
                                            shall pay to IC a royalty equal to the total amount of all unreimbursed patent expenses
                                            paid by the IC prior to the Effective Date of this Agreement for IC’s
                                            preparation, filing, prosecution, and maintenance of all patent applications and patents
                                            included within the Licensed Patent Rights (“Past-patent Costs”). IC’s
                                            will submit to the Licensee a statement and amount for this unreimbursed patent
                                            expenses royalty. Licensee will make payment in the following installments:



 


		(a)	within
                                            thirty (30) days of the date that the authorized signatories of all Parties have signed
                                            this Agreement, a first installment payment of eight thousand five hundred dollars
                                            ($8,500);



 


		(b)	on
                                            or before the first anniversary of the Effective Date, a second installment in the
                                            amount of fifty percent (50%) of the remaining balance of Past-patent Costs; and



 


		(c)	upon
                                            the earliest of (if the dates differ) either the third anniversary of the Effective Date
                                            or, upon the date of termination or expiration of this Agreement, a final installment
                                            in the amount of the total remaining balance of any Past-patent Costs.



 


		6.10	With
                                            regard to unreimbursed expenses associated with the preparation, filing, prosecution, and
                                            maintenance of all patent applications and patents included within the Licensed Patent
                                            Rights and paid by the IC on or after the effective date of this Agreement,
                                            the IC, at its sole option, may require the Licensee:



 


		(a)	to
                                            pay the IC on an annual basis, within sixty (60) days of the IC’s submission
                                            of a statement and request for payment, a royalty amount equivalent to these unreimbursed
                                            expenses paid during the previous calendar year(s);



 


		(b)	to
                                            pay these unreimbursed expenses directly to the law firm employed by the IC to handle
                                            these functions. However, in this event, the IC and not the Licensee shall
                                            be the client of the law firm; or



 


		(c)	in
                                            limited circumstances, the Licensee may be given the right to assume responsibility
                                            for the preparation, filing, prosecution, or maintenance of any patent application or patent
                                            included with the Licensed Patent Rights. In that event, the Licensee shall
                                            directly pay the attorneys or agents engaged to prepare, file, prosecute, or maintain these
                                            patent applications or patents and shall provide the IC with copies of each invoice
                                            associated with these services as well as documentation that these invoices have been paid.



 


		6.11	The
                                            IC agrees, upon written request, to provide the Licensee with summaries of
                                            patent prosecution invoices for which the IC has requested payment from the Licensee
                                            under Paragraphs 6.9 and
                                            6.10. The Licensee agrees that all information provided by the IC related to
                                            patent prosecution costs shall be treated as confidential commercial information and shall
                                            not be released to a third party except as required by law or a court of competent jurisdiction.






 


		6.12	The
                                            Licensee may elect to surrender its rights in any country of the Licensed Territory
                                            under any of the Licensed Patent Rights upon ninety (90) days written notice to
                                            the IC and owe no payment obligation under Paragraph 6.10 for patent-related expenses
                                            paid in that country after ninety (90) days of the effective date of the written notice.



 




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	7.	PATENT
                                            FILING, PROSECUTION, AND MAINTENANCE



 


		7.1	Except
                                            as otherwise provided in this Article 7, the IC agrees to take responsibility for,
                                            but to consult with, the Licensee in the preparation, filing, prosecution, and maintenance
                                            of any and all patent applications or patents included in the Licensed Patent Rights and
                                            shall furnish copies of relevant patent-related documents to the Licensee.



 


		7.2	Upon
                                            the IC’s written request, the Licensee shall assume the responsibility
                                            for the preparation, filing, prosecution, and maintenance of any and all patent applications
                                            or patents included in the Licensed Patent Rights and shall, on an ongoing basis, promptly
                                            furnish copies of all patent-related documents to the IC. In this event, the Licensee
                                            shall, subject to the prior approval of the IC, select registered patent attorneys
                                            or patent agents to provide these services on behalf of the Licensee and the IC.
                                            The IC shall provide appropriate powers of attorney and other documents necessary
                                            to undertake this action to the patent attorneys or patent agents providing these services.
                                            The Licensee and its attorneys or agents shall consult with the IC in all aspects
                                            of the preparation, filing, prosecution and maintenance of patent applications and patents
                                            included within the Licensed Patent Rights and shall provide the IC sufficient
                                            opportunity to comment on any document that the Licensee intends to file or to cause
                                            to be filed with the relevant intellectual property or patent office.



 


		7.3	At
                                            any time, the IC may provide the Licensee with written notice that the IC
                                            wishes to assume control of the preparation, filing, prosecution, and maintenance of
                                            any and all patent applications or patents included in the Licensed Patent Rights.
                                            If the IC elects to reassume these responsibilities, the Licensee agrees to
                                            cooperate fully with the IC, its attorneys, and agents in the preparation, filing,
                                            prosecution, and maintenance of any and all patent applications or patents included in the
                                            Licensed Patent Rights and to provide the IC with complete copies of any and
                                            all documents or other materials that the IC deems necessary to undertake such responsibilities.
                                            The Licensee shall be responsible for all costs associated with transferring patent
                                            prosecution responsibilities to an attorney or agent of the IC’s choice.



 


		7.4	Each
                                            party shall promptly inform the other as to all matters that come to its attention that may
                                            affect the preparation, filing, prosecution, or maintenance of the Licensed Patent Rights
                                            and permit each other to provide comments and suggestions with respect to the preparation,
                                            filing, prosecution, and maintenance of the Licensed Patent Rights, which comments
                                            and suggestions shall be considered by the other party.



 


	8.	RECORD
                                            KEEPING



 


		8.1	The
                                            Licensee agrees to keep accurate and correct records of the Licensed Products
                                            made, used, sold, or imported and the Licensed Processes practiced under this Agreement
                                            appropriate to determine the amount of royalties due the IC. These records shall
                                            be retained for at least five (5) years following a given reporting period and shall be available
                                            during normal business hours for inspection, at the expense of the IC, by an accountant
                                            or other designated auditor selected by the IC for the sole purpose of verifying reports
                                            and royalty payments hereunder. The accountant or auditor shall only disclose to the IC
                                            information relating to the accuracy of reports and royalty payments made under this
                                            Agreement. If an inspection shows an underreporting or underpayment in excess of five
                                            percent (5%) for any twelve (12) month period, then the Licensee shall reimburse the
                                            IC for the cost of the inspection at the time the Licensee pays the unreported
                                            royalties, including any additional royalties as required by Paragraph 9.8. All royalty payments
                                            required under this Paragraph shall be due within sixty (60) days of the date the IC
                                            provides to the Licensee notice of the payment due. If an inspection shows an overpayment,
                                            licensee will be given a credit against the future payment due.



 




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	9.	REPORTS
                                            ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS



 


		9.1	Prior
                                            to signing this Agreement, the Licensee has provided the IC with the
                                            Commercial Development Plan in Appendix E, under which the Licensee intends
                                            to bring the subject matter of the Licensed Patent Rights to the point of Practical
                                            Application. This Commercial Development Plan is hereby incorporated by reference
                                            into this Agreement. Based on this plan, performance Benchmarks are determined
                                            as specified in Appendix D.



 


		9.2	The
                                            Licensee shall provide written annual reports on its product development progress
                                            or efforts to commercialize under the Commercial Development Plan for each of the
                                            Licensed Fields of Use within sixty (60) days after December 31 of each calendar year.
                                            These progress reports shall include, but not be limited to: progress on research and development,
                                            status of applications for regulatory approvals, manufacture and status of sublicensing,
                                            marketing, importing, and sales during the preceding calendar year, as well as, plans for
                                            the present calendar year. The IC also encourages these reports to include information
                                            on any of the Licensee’s public service activities that relate to the Licensed
                                            Patent Rights. If reported progress differs from that projected in the Commercial
                                            Development Plan and Benchmarks, the Licensee shall explain the reasons
                                            for these differences. In the annual report, the Licensee may propose amendments to
                                            the Commercial Development Plan, acceptance of which by the IC may not be denied
                                            unreasonably. The Licensee agrees to provide any additional information reasonably
                                            required by the IC to evaluate the Licensee’s performance under this
                                            Agreement. The Licensee may amend the Benchmarks at any time upon written
                                            approval by the IC. The IC shall not unreasonably withhold approval of any
                                            request of the Licensee to extend the time periods of this schedule if the request
                                            is supported by a reasonable showing by the Licensee of diligence in its performance
                                            under the Commercial Development Plan and toward bringing the Licensed Products
                                            to the point of Practical Application as defined in 37 C.F.R. §404.3(d).
                                            The Licensee shall amend the Commercial Development Plan and Benchmarks
                                            at the request of the IC to address any Licensed Fields of Use not specifically
                                            addressed in the plan originally submitted.



 


		9.3	The
                                            Licensee shall report to the IC the dates for achieving Benchmarks specified
                                            in Appendix D and the First Commercial Sale in each country in the Licensed Territory
                                            within thirty (30) days of such occurrences.



 


		9.4	The
                                            Licensee shall submit to the IC, within sixty (60) days after each calendar
                                            half-year ending June 30 and December 31, a royalty report, as described in the example in
                                            Appendix F, setting forth for the preceding half-year period the amount of the Licensed
                                            Products sold or Licensed Processes practiced by or on behalf of the Licensee
                                            in each country within the Licensed Territory, the Net Sales, and the amount
                                            of royalty accordingly due. With each royalty report, the Licensee shall submit payment
                                            of earned royalties due. If no earned royalties are due to the IC for any reporting
                                            period, the written report shall so state. The royalty report shall be certified as correct
                                            by an authorized officer of the Licensee and shall include a detailed listing of all
                                            deductions made under Paragraph 2.16 to determine Net Sales made under Article 6 to
                                            determine royalties due. The royalty report shall also identify the site of manufacture for
                                            the Licensed Product(s) sold in the United States.



 


		9.5	The
                                            Licensee agrees to forward semi-annually to the IC a copy of these reports
                                            received by the Licensee from its sublicensees during the preceding half-year period
                                            as shall be pertinent to a royalty accounting to the IC by the Licensee for
                                            activities under the sublicense.



 




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		9.6	Royalties
                                            due under Article 6 shall be paid in U.S. dollars and payment options are listed in Appendix
                                            G. For conversion of foreign currency to U.S. dollars, the conversion rate shall be the New
                                            York foreign exchange rate quoted in The Wall Street Journal on the day that the payment
                                            is due. Any loss of exchange, value, taxes, or other expenses incurred in the transfer or
                                            conversion to U.S. dollars shall be paid entirely by the Licensee. The royalty report
                                            required by Paragraph 9.4
shall be mailed to the IC at its address for Agreement Notices indicated on the Signature Page.
	 	 	 
		9.7	The
                                            Licensee shall be solely responsible for determining if any tax on royalty income
                                            is owed outside the United States and shall pay the tax and be responsible for all filings
                                            with appropriate agencies of foreign governments.



 


		9.8	Additional
                                            royalties may be assessed by the IC on any payment that is more than ninety (90) days
                                            overdue at the rate of one percent (1%) per month. This one percent (1%) per month rate may
                                            be applied retroactively from the original due date until the date of receipt by the IC
                                            of the overdue payment and additional royalties. The payment of any additional royalties
                                            shall not prevent the IC from exercising any other rights it may have as a consequence
                                            of the lateness of any payment.



 


		9.9	All
                                            plans and reports required by this Article 9 and marked “confidential” by the
                                            Licensee shall, to the extent permitted by law, be treated by the IC as commercial
                                            and financial information obtained from a person and as privileged and confidential, and
                                            any proposed disclosure of these records by the IC under the Freedom of Information
                                            Act (FOIA), 5 U.S.C. §552 shall be subject to the predisclosure notification
                                            requirements of 45 C.F.R. §5.65(d).



 


	10.	PERFORMANCE



 


		10.1	The
                                            Licensee shall use its reasonable commercial efforts to bring the Licensed Products
                                            and the Licensed Processes to Practical Application. “Reasonable
                                            commercial efforts” for the purposes of this provision shall include adherence to the
                                            Commercial Development Plan in Appendix E and performance of the Benchmarks
                                            in Appendix D. The efforts of a sublicensee shall be considered the efforts of the Licensee.



 


		10.2	Upon
                                            the First Commercial Sale, until the expiration or termination of this Agreement,
                                            the Licensee shall use its reasonable commercial efforts to make the Licensed Products
                                            and the Licensed Processes reasonably accessible to the United States public.



 


		10.3	The
                                            Licensee agrees, after its First Commercial Sale, to make reasonable quantities
                                            of the Licensed Products or materials produced through the use of the Licensed Processes
                                            available to patient assistance programs.



 


		10.4	The
                                            Licensee agrees, after its First Commercial Sale and as part of its marketing
                                            and product promotion, to develop educational materials (e.g., brochures, website, etc.)
                                            directed to patients and physicians detailing the Licensed Products or medical aspects
                                            of the prophylactic and therapeutic uses of the Licensed Products.



 


		10.5	The
                                            Licensee agrees to supply, to the Mailing Address for Agreement Notices indicated
                                            on the Signature Page, the Office of Technology Transfer, NIH with inert samples of
                                            the Licensed Products or the Licensed Processes or their packaging for educational
                                            and display purposes only.



 




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	11.	INFRINGEMENT
                                            AND PATENT ENFORCEMENT



 


		11.1	The
                                            IC and the Licensee agree to notify each other promptly of each infringement
                                            or possible infringement of the Licensed Patent Rights, as well as, any facts which
                                            may affect the validity, scope, or enforceability of the Licensed Patent Rights of
                                            which either party becomes aware.



 


		11.2	Pursuant
                                            to this Agreement and the provisions of 35 U.S.C. Chapter 29, the Licensee
                                            may:



 


		(a)	bring
                                            suit in its own name, at its own expense, and on its own behalf for infringement of presumably
                                            valid claims in the Licensed Patent Rights;



 


		(b)	in
                                            any suit, enjoin infringement and collect for its use, damages, profits, and awards of whatever
                                            nature recoverable for the infringement; or



 


		(c)	settle
                                            any claim or suit for infringement of the Licensed Patent Rights provided, however,
                                            that the IC and appropriate Government authorities shall have the first right
                                            to take such actions; and



 


		(d)	if
                                            the Licensee desires to initiate a suit for patent infringement, the Licensee
                                            shall notify the IC in writing. If the IC does not notify the Licensee
                                            of its intent to pursue legal action within ninety (90) days, the Licensee shall be
                                            free to initiate suit. The IC shall have a continuing right to intervene in the suit.
                                            The Licensee shall take no action to compel the Government either to initiate
                                            or to join in any suit for patent infringement. The Licensee may request the Government
                                            to initiate or join in any suit if necessary to avoid dismissal of the suit. Should the
                                            Government be made a party to any suit, the Licensee shall reimburse the Government
                                            for any costs, expenses, or fees which the Government incurs as a result of the
                                            motion or other action, including all costs incurred by the Government in opposing
                                            the motion or other action. In all cases, the Licensee agrees to keep the IC
                                            reasonably apprised of the status and progress of any litigation. Before the Licensee
                                            commences an infringement action, the Licensee shall notify the IC and
                                            give careful consideration to the views of the IC and to any potential effects of
                                            the litigation on the public health in deciding whether to bring suit.



 


		11.3	In
                                            the event that a declaratory judgment action alleging invalidity or non-infringement of any
                                            of the Licensed Patent Rights shall be brought against the Licensee or raised
                                            by way of counterclaim or affirmative defense in an infringement suit brought by the Licensee
                                            under Paragraph 11.2, pursuant to this Agreement and the provisions of 35 U.S.C.
                                            Chapter 29 or other statutes, the Licensee may:



 


		(a)	defend
                                            the suit in its own name, at its own expense, and on its own behalf for presumably valid
                                            claims in the Licensed Patent Rights;



 


		(b)	in
                                            any suit, ultimately to enjoin infringement and to collect for its use, damages, profits,
                                            and awards of whatever nature recoverable for the infringement; and



 


		(c)	settle
                                            any claim or suit for declaratory judgment involving the Licensed Patent Rights-provided,
                                            however, that the IC and appropriate Government authorities shall have the
                                            first right to take these actions and shall have a continuing right to intervene in the suit;
                                            and



 




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		(d)	if
                                            the IC does not notify the Licensee of its intent to respond to the legal action
                                            within a reasonable time, the Licensee shall be free to do so. The Licensee
                                            shall take no action to compel the Government either to initiate or to join in any
                                            declaratory judgment action. The Licensee may request the Government to initiate
                                            or to join any suit if necessary to avoid dismissal of the suit. Should the Government
                                            be made a party to any suit by motion or any other action of the Licensee, the
                                            Licensee shall reimburse the Government for any costs, expenses, or fees, which
                                            the Government incurs as a result of the motion or other action. If the Licensee
                                            elects not to defend against the declaratory judgment action, the IC, at its option,
                                            may do so at its own expense. In all cases, the Licensee agrees to keep the IC
                                            reasonably apprised of the status and progress of any litigation. Before the Licensee
                                            commences an infringement action, the Licensee shall notify the IC and
                                            give careful consideration to the views of the IC and to any potential effects of
                                            the litigation on the public health in deciding whether to bring suit.



 


		11.4	In
                                            any action under Paragraphs 11.2 or 11.3 the expenses including costs, fees, attorney fees,
                                            and disbursements, shall be paid by the Licensee. The value of any recovery made by
                                            the Licensee through court judgment or settlement shall be treated as Net Sales
                                            and subject to earned royalties.



 


		11.5	The
                                            IC shall cooperate fully with the Licensee in connection with any action under
                                            Paragraphs 11.2
or 11.3. The IC agrees promptly to provide access to all necessary documents and to render reasonable assistance in response to
a request by the Licensee.



 


	12.	NEGATION
                                            OF WARRANTIES AND INDEMNIFICATION



 


		12.1	The
                                            IC offers no warranties other than those specified in Article 1.



 


		12.2	The
                                            IC does not warrant the validity of the Licensed Patent Rights and makes no
                                            representations whatsoever with regard to the scope of the Licensed Patent Rights,
                                            or that the Licensed Patent Rights may be exploited without infringing other patents
                                            or other intellectual property rights of third parties.



 


		12.3	THE
                                            IC MAKES NO WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
                                            PURPOSE OF ANY SUBJECT MATTER DEFINED BY THE CLAIMS OF THE LICENSED PATENT RIGHTS OR
                                            TANGIBLE MATERIALS RELATED THERETO.



 


		12.4	The
                                            IC does not represent that it shall commence legal actions against third parties infringing
                                            the Licensed Patent Rights.



 


		12.5	The
                                            Licensee shall indemnify and hold the IC, its employees, students, fellows,
                                            agents, and consultants harmless from and against all liability, demands, damages, expenses,
                                            and losses, including but not limited to death, personal injury, illness, or property damage
                                            in connection with or arising out of:



 


		(a)	the
                                            use by or on behalf of the Licensee, its sublicensees, directors, employees, or third
                                            parties of any Licensed Patent Rights; or



 




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		(b)	the
                                            design, manufacture, distribution, or use of any Licensed Products, Licensed Processes
                                            or materials by the Licensee, or other products or processes developed in connection
                                            with or arising out of the Licensed Patent Rights.



 


		12.6	The
                                            Licensee agrees to maintain a liability insurance program consistent with sound business
                                            practice.



 


	13.	TERM,
                                            TERMINATION, AND MODIFICATION OF RIGHTS



 


		13.1	This
                                            Agreement shall not take effect unless and until:



 


		(a)	Licensee
                                            has paid to the IC a noncreditable, nonrefundable license issue royalty in the
                                            amount and as set as set forth in Appendix B;



 


		(b)	Licensee
                                            has paid the first royalty installment for Past-patent Costs reimbursement,
under paragraph 6.9(a); and



 


		(c)	the
                                            Agreement has been signed by the authorized representatives of the parties, in accordance
                                            to the provisions of Paragraph 14.16.



 


Upon
fulfillment of all conditions under this paragraph 13.1(a-c), this Agreement is effective on the Effective Date.


 


		13.2	This
                                            Agreement shall take effect on the Effective Date and shall expire (unless
                                            sooner terminated as provided in this Article 13) either:



 


		(a)	Thirty-six
                                            (36) months from the Effective Date, if not extended in accordance with 13.2 (b);
                                            or



 


		(b)	if
                                            Licensee has (i) paid to the IC the License Extension Royalty as specified
                                            in Appendix C (IV), and (ii) provided IC written evidence of commercially reasonable
                                            progress toward Licensee-sponsored clinical studies of a Licensed Product and
                                            adherence with the Commercial Development Plan, (such evidence may include, but
                                            is not limited to, completed experiments showing non-clinical pharmacology or toxicology
                                            data, and any completed regulatory filings) on the date of the last to expire of the
                                            Licensed Patent Rights.



 


		13.3	In
                                            the event that the Licensee is in default in the performance of any material obligations
                                            under this Agreement, including but not limited to the obligations listed in Paragraph
                                            13.5, and if the default has not been remedied within ninety (90) days after the date of
                                            notice in writing of the default, the IC may terminate this Agreement by written
                                            notice and pursue outstanding royalties owed through procedures provided by the Federal
                                            Debt Collection Act.



 


		13.4	In
                                            the event that the Licensee becomes insolvent, files a petition in bankruptcy, has
                                            such a petition filed against it, determines to file a petition in bankruptcy, or receives
                                            notice of a third party’s intention to file an involuntary petition in bankruptcy,
                                            the Licensee shall immediately notify the IC in writing.



 


		13.5	The
                                            Licensee shall have a unilateral right to terminate this Agreement or any licenses
                                            in any country or territory by giving the IC sixty (60) days written notice to that
                                            effect.



 




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		13.6	The
                                            IC shall specifically have the right to terminate or modify, at its option, this Agreement,
                                            if the IC determines that the Licensee:



 


		(a)	is
                                            not executing the Commercial Development Plan submitted with its request for a license
                                            and the Licensee cannot otherwise demonstrate to the IC’s satisfaction
                                            that the Licensee has taken, or can be expected to take within a reasonable time,
                                            effective steps to achieve the Practical Application of the Licensed Products or
                                            the Licensed Processes;



 


		(b)	has
                                            not achieved the Benchmarks as may be modified under Paragraph 9.2;



 


		(c)	has
                                            willfully made a false statement of, or willfully omitted a material fact in the license
                                            application or in any report required by this Agreement;



 


		(d)	has
                                            committed a material breach of a covenant or agreement contained in this Agreement;



 


		(e)	is
                                            not keeping the Licensed Products or the Licensed Processes reasonably available
                                            to the public after commercial use commences;



 


		(f)	cannot
                                            reasonably satisfy unmet health and safety needs; or



 


		(g)	cannot
                                            reasonably justify a failure to comply with the domestic production requirement of Paragraph
                                            5.2 unless waived or



 


		(h)	has
                                            been found by a court of competent jurisdiction to have violated the Federal antitrust laws
                                            in connection with its performance under this Agreement.



 


		13.7	In
                                            making the determination referenced in Paragraph 13.5, the IC shall take into account
                                            the normal course of such commercial development programs conducted with sound and reasonable
                                            business practices and judgment and the annual reports submitted by the Licensee under
                                            Paragraph 9.2. Prior to invoking termination or modification of this Agreement under
                                            Paragraph 13.5, the IC shall give written notice to the Licensee providing
                                            the Licensee specific notice of, and a ninety (90) day opportunity to respond to,
                                            the IC’s concerns as to the items referenced in 13.5(a)-13.5(g). If the Licensee
                                            fails to alleviate the IC’s concerns as to the items referenced in 13.5(a)-13.5(g)
                                            or fails to initiate corrective action to the IC’s satisfaction, the IC
                                            may terminate this Agreement.



 


		13.8	When
                                            the public health and safety so require, and after written notice to the Licensee providing
                                            the Licensee a sixty (60) day opportunity to respond, the IC shall have the
                                            right to require the Licensee to grant sublicenses to responsible applicants, on reasonable
                                            terms, in any Licensed Fields of Use under the Licensed Patent Rights, unless
                                            the Licensee can reasonably demonstrate that the granting of the sublicense would
                                            not materially increase the availability to the public of the subject matter of the Licensed
                                            Patent Rights. The IC shall not require the granting of a sublicense unless the
                                            responsible applicant has first negotiated in good faith with the Licensee.



 


		13.9	The
                                            IC reserves the right according to 35 U.S.C. §209(d)(3) to terminate or
                                            modify this Agreement if it is determined that this action is necessary to meet the
                                            requirements for public use specified by federal regulations issued after the date of the
                                            license and these requirements are not reasonably satisfied by the Licensee.



 




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		13.10	Within
                                            thirty (30) days of receipt of written notice of the IC’s unilateral decision
                                            to modify or terminate this Agreement, the Licensee may, consistent with the
                                            provisions of 37 C.F.R. §404.11, appeal the decision by written submission to
                                            the designated IC official or designee. The decision of the designated IC official
                                            or designee shall be the final agency decision. The Licensee may thereafter exercise
                                            any and all administrative or judicial remedies that may be accessible.



 


		13.11	Within
                                            ninety (90) days of expiration or termination of this Agreement under this Article
                                            13, a final report shall be submitted by the Licensee. Any royalty payments, including
                                            those incurred but not yet paid (such as the full minimum annual royalty), and those related
                                            to patent expenses, due to the IC shall become immediately due and payable upon termination
                                            or expiration. If terminated under this Article 13, sublicensees may elect to convert their
                                            sublicenses to direct licenses with the IC pursuant to Paragraph 4.3. Unless otherwise
                                            specifically provided for under this Agreement, upon termination or expiration of
                                            this Agreement, the Licensee shall return all Licensed Products or other
                                            materials included within the Licensed Patent Rights to the IC or provide the
                                            IC with certification of the destruction thereof. The Licensee may not be granted
                                            additional IC licenses if the final reporting requirement is not fulfilled.



 


	14.	GENERAL
                                            PROVISIONS



 


		14.1	Neither
                                            party may waive or release any of its rights or interests in this Agreement except
                                            in writing. The failure of the either Party to assert a right hereunder or to insist
                                            upon compliance with any term or condition of this Agreement shall not constitute
                                            a waiver of that right or excuse a similar subsequent failure to perform any of these terms
                                            or conditions by the Licensee.



 


		14.2	This
                                            Agreement constitutes the entire agreement between the parties relating to the subject
                                            matter of the Licensed Patent Rights, the Licensed Products and the Licensed
                                            Processes, and all prior negotiations, representations, agreements, and understandings
                                            are merged into, extinguished by, and completely expressed by this Agreement.



 


		14.3	The
                                            provisions of this Agreement are severable, and in the event that any provision of
                                            this Agreement shall be determined to be invalid or unenforceable under any controlling
                                            body of law, this determination shall not in any way affect the validity or enforceability
                                            of the remaining provisions of this Agreement.



 


		14.4	If
                                            either party desires a modification to this Agreement, the parties shall, upon reasonable
                                            notice of the proposed modification by the party desiring the change, confer in good faith
                                            to determine the desirability of the modification. No modification shall be effective until
                                            a written amendment is signed by the signatories to this Agreement or their designees.



 


		14.5	The
                                            construction, validity, performance, and effect of this Agreement shall be governed
                                            by Federal law as applied by the Federal courts in the District of Columbia.



 


		14.6	All
                                            Agreement notices required or permitted by this Agreement shall be given by
                                            prepaid, first class, registered or certified mail or by an express/overnight delivery service
                                            provided by a commercial carrier, properly addressed to the other party at the address designated
                                            on the following Signature Page, or to another address as may be designated in writing by
                                            the other party. Agreement notices shall be considered timely if the notices are received
                                            on or before the established deadline date or sent on or before the deadline date as verifiable
                                            by U.S. Postal Service postmark or dated receipt from a commercial carrier. Parties should
                                            request a legibly dated U.S. Postal Service postmark or obtain a dated receipt from a commercial
                                            carrier or the U.S. Postal Service. Private metered postmarks shall not be acceptable as
                                            proof of timely mailing.



 




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		14.7	This
                                            Agreement shall not be assigned or otherwise transferred (including any transfer by
                                            legal process or by operation of law, and any transfer in bankruptcy or insolvency, or in
                                            any other compulsory procedure or order of court) except to the Licensee’s Affiliate(s)
                                            without the prior written consent of the IC. The parties agree that the identity
                                            of the parties is material to the formation of this Agreement and that the obligations
                                            under this Agreement are nondelegable. In the event that the IC approves a
                                            proposed assignment, the Licensee shall pay the IC, as an additional royalty,
                                            three percent (3%) of the fair market value of any consideration paid to the Licensee
                                            for any assignment of this Agreement within sixty (60) days Licensee’s
                                            receipt of the payments.



 


		14.8	The
                                            Licensee agrees in its use of any IC-supplied materials to comply with all
                                            applicable statutes, regulations, and guidelines, including NIH and HHS regulations
                                            and guidelines. The Licensee agrees not to use the materials for research involving
                                            human subjects or clinical trials in the United States without complying with 21 C.F.R.
                                            Part 50 and 45 C.F.R. Part 46. The Licensee agrees not to use the materials
                                            for research involving human subjects or clinical trials outside of the United States without
                                            notifying the IC, in writing, of the research or trials and complying with the applicable
                                            regulations of the appropriate national control authorities. Written notification to the
                                            IC of research involving human subjects or clinical trials outside of the United States
                                            shall be given no later than sixty (60) days prior to commencement of the research or trials.



 


		14.9	The
                                            Licensee acknowledges that it is subject to and agrees to abide by the United States
                                            laws and regulations (including the Export Administration Act of 1979 and Arms
                                            Export Control Act) controlling the export of technical data, computer software, laboratory
                                            prototypes, biological material, and other commodities. The transfer of these items may require
                                            a license from the appropriate agency of the U.S. Government or written assurances
                                            by the Licensee that it shall not export these items to certain foreign countries
                                            without prior approval of this agency. The IC neither represents that a license is
                                            or is not required or that, if required, it shall be issued.



 


		14.10	The
                                            Licensee agrees to mark the Licensed Products or their packaging sold in the
                                            United States with all applicable U.S. patent numbers and similarly to indicate “Patent
                                            Pending” status. All the Licensed Products manufactured in, shipped to, or sold
                                            in other countries shall be marked in a manner to preserve the IC’s patent rights
                                            in those countries.



 


		14.11	By
                                            entering into this Agreement, the IC does not directly or indirectly endorse
                                            any product or service provided, or to be provided, by the Licensee whether directly
                                            or indirectly related to this Agreement. The Licensee shall not state or imply
                                            that this Agreement is an endorsement by the Government, the IC, any
                                            other Government organizational unit, or any Government employee. Additionally,
                                            the Licensee shall not use the names of the IC, the FDA or the HHS
                                            or the Government or their employees in any advertising, promotional, or sales
                                            literature without the prior written approval of the IC.



 


		14.12	The
                                            parties agree to attempt to settle amicably any controversy or claim arising under this Agreement
                                            or a breach of this Agreement, except for appeals of modifications or termination
                                            decisions provided for in Article 13. The Licensee agrees first to appeal any unsettled
                                            claims or controversies to the designated IC official, or designee, whose decision
                                            shall be considered the final agency decision. Thereafter, the Licensee may exercise
                                            any administrative or judicial remedies that may be available.



 


		14.13	Nothing
                                            relating to the grant of a license, nor the grant itself, shall be construed to confer upon
                                            any person any immunity from or defenses under the antitrust laws or from a charge of patent
                                            misuse, and the acquisition and use of rights pursuant to 37 C.F.R. Part 404 shall
                                            not be immunized from the operation of state or Federal law by reason of the source of the
                                            grant.



 




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		14.14	Any
                                            formal recordation of this Agreement required by the laws of any Licensed Territory
                                            as a prerequisite to enforceability of the Agreement in the courts of any foreign
                                            jurisdiction or for other reasons shall be carried out by the Licensee at its expense,
                                            and appropriately verified proof of recordation shall be promptly furnished to the IC.



 


		14.15	Paragraphs
                                            4.4, 8.1, 9.5-9.8, 12.1-12.5, 13.9, 13.10, 14.12 and 14.15 of this Agreement shall
                                            survive termination of this Agreement.



 


		14.16	The
                                            terms and conditions of this Agreement shall, at the IC’s sole option,
                                            be considered by the IC to be withdrawn from the Licensee’s consideration
                                            and the terms and conditions of this Agreement, and the Agreement itself to
                                            be null and void, unless this Agreement is executed by the Licensee and a fully
                                            executed original is received by the IC within sixty (60) days from the date of the
                                            IC’s signature found at the Signature Page.



 


SIGNATURES
BEGIN ON NEXT PAGE


 




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NIH
PATENT LICENSE AGREEMENT – EXCLUSIVE


 


SIGNATURE
PAGE


 


	For
    the IC:	 	 
	 	 	 
	/s/Mala Dutta	 	 
	Mala
    Dutta, Ph.D.	 	Date
	Technology
    Development Coordinator	 	 
	National
    Eye Institute	 	 
	National
    Institutes of Health	 	 


 


	/s/Brian
    Trent	 	 
	Brian
    Trent	 	Date
	Executive
    Officer	 	 
	National
    Eye Institute	 	 
	National
    Institutes of Health	 	 


 


	/s/
Santa Tumminia	 	 
	Santa
    Tumminia, Ph.D.	 	Date
	Deputy
    Director	 	 
	National
    Eye Institute	 	 
	National
    Institutes of Health	 	 


 


Mailing
Address or E-mail Address for Agreement notices and reports:


 


License
Compliance and Administration


Monitoring
& Enforcement


Office
of Technology Transfer


National
Institutes of Health


6011
Executive Boulevard, Suite 325


Rockville,
Maryland 20852-3804 U.S.A.


 


E-
mail: LicenseNotices_Reports@mail.nih.gov




 




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For
the Licensee (Upon, information and belief, the undersigned expressly certifies or affirms that the contents of any statements of the
Licensee made or referred to in this document are truthful and accurate.):


 


	by:	 	 
	 	 	 
	Signature
    of Authorized Official	 	Date
	 	 	 
	Paul
    Michaels	 	 
	Chairman
    & President	 	 


 


I.
Official and Mailing Address for Agreement notices:


 


Paul
Michaels, Chairman


Connectyx
Technologies Holdings


1825
NW Corporate Blvd, Suite 110


Boca
Raton, Florida 33431


Email:
pmichaels@connectyx.com


Phone:
561 418 7725


 


II.
Official and Mailing Address for Financial notices (the Licensee’s contact person for royalty payments)


 


Paul
Michaels, Chairman


Connectyx
Technologies Holdings


1825
NW Corporate Blvd, Suite 110


Boca
Raton, Florida 33431


Email:
pmichaels@connectyx.com


Phone:
561 418 7725


 


Any
false or misleading statements made, presented, or submitted to the Government, including any relevant omissions, under this Agreement
and during the course of negotiation of this Agreement are subject to all applicable civil and criminal statutes including
Federal statutes 31 U.S.C. §§3801-3812 (civil liability) and 18 U.S.C. §1001 (criminal liability including
fine(s) or imprisonment).


 




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APPENDIX
A – PATENT(S) OR PATENT APPLICATION(S)


 


Patent(s)
or Patent Application(s):


 


	I.	U.S.
                                            Provisional Patent Application No. 62/899,899 filed 13 September 2019; HHS Ref No.
                                            E-227-2018-0- US-01



 


	II.	PCT
                                            Application No. PCT/US2020/050540 filed 11 September 2020; HHS Ref. No. E-227-2018-0-PCT-
                                            02



 




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APPENDIX
B – LICENSED FIELDS OF USE AND TERRITORY


 


	I.	Licensed
                                            Fields of Use: therapeutics to treat retinal degenerative diseases in human



 


	II.	Licensed
                                            Territory: Worldwide, wherever the Licensed Patent Rights are pending or
                                            issued.



 




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APPENDIX
C – ROYALTIES


 


Royalties:


 


	I.	The
                                            Licensee agrees to pay to the IC a noncreditable, nonrefundable license issue
                                            royalty in the amount of five thousand dollars ($5,000) within thirty (30) days from the
                                            Signature Date of this Agreement.



 


	II.	The
                                            Licensee agrees to pay to the IC a nonrefundable annual royalty in the amount
                                            of five thousand dollars ($5,000) as follows:



 


		(a)	The
                                            first minimum annual royalty is due within sixty (60) days of the second anniversary of the
                                            Effective Date of this Agreement; and



 


		(b)	Subsequent
                                            annual royalty payments are due and payable on January 1 of each calendar year and may be
                                            credited against any earned royalties due for sales made in that year.



 


	III.	The
                                            Licensee agrees to pay the IC earned royalties of three and a half percent
                                            (3.5%) on Net Sales by or on behalf of the Licensee and its sublicensees.



 


	IV.	License
                                            Extension Royalty: Prior to expiration of this agreement thirty-six (36) months from
                                            the Effective Date and Licensee may pay an optional, one-time, nonrefundable,
                                            noncreditable license extension royalty of forty-five thousand dollars ($45,000) to extend
                                            the expiration date of this Agreement in accordance with paragraph 13.2(b).



 


	V.	The
                                            Licensee agrees to pay the IC Benchmark royalties within sixty (60) days of
                                            achieving each Benchmark:



 


		(a)	seventy-five
                                            thousand dollars ($75,000) upon initiation of the first Phase 2 Clinical Study for
                                            a Licensed Product in the Licensed Field of Use;



 


		(b)	three
                                            hundred thousand dollars ($300,000) for first completion Phase 3 Clinical Study for
                                            a Licensed Product in the Licensed Field of Use;



 


		(c)	Six
                                            hundred thousand dollars ($600,000) upon FDA approval of the first Licensed Product
                                            in the Licensed Field of Use.



 


		(d)	Upon
                                            the First Commercial Sale in any country of each of the four geographic regions (1-4
                                            below) where Licensed Patent Rights are pending or exist, Licensee shall pay
                                            a one-time royalty as follows:



 


		(1)	United
                                            States: one hundred thousand dollars ($100,000);



		(2)	Canada:
                                            one hundred thousand dollars ($100,000);



		(3)	European
                                            Union region (including UK): one hundred thousand dollars ($100,000);



		(4)	Asian
                                            region (Japan, China, Korea, Australia): one hundred thousand dollars ($100,000).



 


	VI.	The
                                            Licensee agrees to pay the IC additional sublicensing royalties of twelve percent
                                            (12%) on the fair market value of any consideration received by licensee under the terms
                                            of all sublicenses granted by Licensee within sixty (60) days of the execution of
                                            each sublicense.



 




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APPENDIX
D – BENCHMARKS AND PERFORMANCE


 


The
Licensee agrees to the following Benchmarks for its performance under this Agreement and, within thirty (30) days
of achieving a Benchmark, shall notify the IC that the Benchmark has been achieved.


 


	I.	On
                                            or before Five (5) months from the Effective Date, initiate any pre-clinical study
                                            activities, as needed, under target points of 2.1 and 3.1 in the Commercial Development
                                            Plan;



 


	II.	On
                                            or before twenty-four (24) months from the Effective Date, complete a Phase 1 Clinical
                                            Study or initiate a Phase 2 Clinical Study for treatment of a first indicated
                                            disease within the Field of Use using a Licensed Product;



 


	III.	On
                                            or before thirty-six (36) months from the Effective Date, complete a Phase 2 Clinical
                                            Study or initiate a Phase 3 Clinical Study for treatment of a first indicated
                                            disease within the Field of Use using a Licensed Product;



 


	IV.	On
                                            or before forty-eight (48) months from the Effective Date, complete a First Commercial
                                            Sale of a Licensed Product to treat a first indicated disease within the Field
                                            of Use;



 


	V.	On
                                            or before sixty (60) months from the Effective Date, initiate clinical studies for
                                            treatment of an at least a second indicated disease within the Field of Use using
                                            a Licensed Product;



 


	VI.	On
                                            or before one hundred and twenty (120) months, complete a First Commercial Sale of
                                            a Licensed Product to treat at least a second indicated disease with the Field
                                            of Use.



 




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APPENDIX
E – COMMERCIAL DEVELOPMENT PLAN


 





 


Chemistry,
Manufacturing, and Control (CMC):


 


		●	A
                                            gap analysis will be performed on the information provided by Eye Institute to assess what
                                            development may be required for pre-IND and IND preparation.



		●	SME
                                            consultants (1) will be used to supervise the analytical and process development, formulation
                                            development, method qualification, manufacturing and fill-finish, release and stability testing,
                                            and subsequent labelling, storage, shipment and inventory management at the clinic.



		●	SME
                                            consultants (1) will be used to supervise regulatory needs for the program including but
                                            not restricted to IND submission and maintenance.



		●	SME
                                            consultants (1) will be used to supervise and oversee the quality needs for the program including
                                            but not restricted to QC release and stability testing, and oversight function of CDMOs.



		●	CDMOs
                                            (1-2) will be contracted to manufacture the GMP drug product, QC release and stability test,
                                            analytical characterization as needed, product in applicator labelling, storage, shipment
                                            and inventory management.



		●	SMEs
                                            selected should have greater than 20 years experience in the pharmaceutical industry for
                                            manufacturing, etc., in each area of specialization.



		●	CMC
                                            Program Outline:



 




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		●	Irrespective
                                            of either a conventional Ph.1/2 followed by Ph. 3 clinical development strategy or a Ph.1/3
                                            accelerated clinical development strategy, the initial CMC development steps from Target
                                            Points 2 through 4 are equivalent.



		●	In
                                            the case of a conventional clinical development strategy, Process A would transition into
                                            Process B as needed and progress along the entire PD&C strategy and timeline. Process
                                            A is designed to be a “fastest to clinic” process while Process B is designed
                                            to be a strong, commercially supportable process.



		●	In
                                            the case of an accelerated clinical development strategy, Process A remains in place for
                                            the Ph.3 studies and becomes the commercial process.



 


Target
Points (TP) 2.1 for Metformin


 





 


Specific
Points for TP2.1: Preparation for First in Human (FIH) GMP Manufacture:


 


		●	Non
                                            compendia analytical methods for characterization and QC release and stability testing will
                                            be transferred and/or developed and qualified sufficient (in case of QC release needs) for
                                            Ph.1 use.



		●	Compendia
                                            Analytical methods will be verified at the will be used as needed for establishing non- compendia
                                            and compendia tests, and for product characterization.



		●	If
                                            GMP material has also been made available and it is different from non-GMP material used
                                            for pre-clinical and non-clinical safety studies, comparability analysis will be performed.



		●	If
                                            the gap analysis determines that there are insufficiently robust non-clinical safety studies
                                            and/or pre-clinical evidentiary studies, those activities will be completed using non-GMP
                                            material received.



 




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		●	Process
                                            and formulation development studies may be performed based on the assessment of information
                                            provided.



 


Phase1
(Ph.1) Target Product Profile (Process A suitable for FIH):


 


		●	The
                                            expected target process profile for Ph.1 will be a drug-product process yielding sufficient
                                            amount to be manufactured to cover the path forward.



		●	A
                                            strategy of product manufacturing from formulation through the completed drug product will
                                            be applied to reduce time and cost associated with managing drug intermediates.



		●	The
                                            target product profile will be a liquid formulation in either an eye dropper vial or single
                                            use dropper packaging that is stable for at least 2 years at a recommended storage conditions
                                            RT or 2- 8C.



 


Target
Points 3.1 and 3.2 for Metformin:


 


  





 




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Specific
Points for TP3.1 and 3.2: FIH GMP Manufacture, IND and Clinical Initiation:


 


		●	Process
                                            for manufacturing of drug product manufacture will be transferred to an identified CDMOs
		●	Analytical
                                            methods (non compendia) will be transferred and qualified suitable for Ph.1 (per EU clinical
                                            trial directive) release and stability testing. Compendia methods will be verified at the
                                            testing CDMO.
		●	Stability
                                            testing chambers at CDMO will be retained.
		●	Clinical
                                            label, storage and shipping CDMOs will be retained and aligned for integrated operations.
		●	Purchased
                                            API and manufacture of drug product will be QC tested and QA released for clinical use. Materials
                                            will be stored for (1) use and (2) in stability chambers per ICH guidelines for drug substance
                                            and drug product stability testing while the material is (at least) in clinic. Thirty days
                                            lead stability of GMP drug product will be used to file the IND.
	 	●	Manufactured
drug product will be labeled, stored and shipped via retained CDMOs.



 





Target
Point 4.1 for Metformin: Completion of FIH Ph.1:


 




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Summary
of Target Points for 4.2 through 7.1 for Metformin:


 


		●	For
                                            the conventional clinical development process (Ph.2, Ph.3, NDA submission) relevant activities
                                            outlined in TP 4.2 – 7.1 are executed at third party CDMOs with



		●	oversight
                                            by Licensee



		●	For
                                            the accelerated clinical development process (Ph.1/Ph.3 executed already and now move to
                                            registration studies) the following aspects of TP 4.2 – 7.1 are modified:



		○	No
                                            Process B activities. Process A becomes the commercial process.



		○	No
                                            technical transfers to commercial CDMOs. Instead, commercially capable CDMOs will be selected
                                            for Ph.1 steps to avoid transfers.



		○	No
                                            reformulation or changes to drug product presentation in applicator from Ph.1.



 


Remaining
activities in the CMC Development strategy:


 


		●	Scale
                                            up manufacturing to meet commercial scale need.



		●	Commercial
                                            process validation at the commercial manufacturing site.



		●	Commercial
                                            analytical method validation at the commercial testing site(s).



		●	Initiation
                                            of long-term stability of commercial drug product (LTSS) with a minimum regulatory accepted
                                            shelf-life at BLA submission (updatable during review).



		●	Commercial
                                            validation of label, shipping, etc. for final product.



 




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APPENDIX
F – EXAMPLE ROYALTY REPORT


 


Required
royalty report information includes:


 


	●	License
                                            reference number (L-XXX-200X/0)



	●	Reporting
                                            period



	●	Catalog
                                            number and units sold of each Licensed Product (domestic and foreign)



	●	Gross
                                            Sales per catalog number per country



	●	Total
                                            Gross Sales



	●	Itemized
                                            deductions from Gross Sales



	●	Total
                                            Net Sales



	●	Earned
                                            Royalty Rate and associated calculations



	●	Gross
                                            Earned Royalty



	●	Adjustments
                                            for Minimum Annual Royalty (MAR) and other creditable payments made



	●	Net
                                            Earned Royalty due



 


Example


 


	Catalog Number	 	Product Name	 	Country	 	Units Sold	 	Gross Sales (US$)	 
	1	 	A	 	US	 	250	 	 	62,500	 
	1	 	A	 	UK	 	32	 	 	16,500	 
	1	 	A	 	France	 	25	 	 	15,625	 
	2	 	B	 	US	 	0	 	 	0	 
	3	 	C	 	US	 	57	 	 	57,125	 
	4	 	D	 	US	 	12	 	 	1,500	 
	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Total Gross Sales	 	 	153,250	 
	 	 	 	 	 	 	Less Deductions:	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Freight	 	 	3,000	 
	 	 	 	 	 	 	Returns	 	 	7,000	 
	 	 	 	 	 	 	Total Net Sales	 	 	143,250	 
	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	Royalty Rate	 	 	8	%
	 	 	 	 	 	 	Royalty Due	 	 	11,460	 
	 	 	 	 	 	 	Less Creditable Payments	 	 	10,000	 
	 	 	 	 	 	 	Net Royalty Due	 	 	1,460	 



 




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APPENDIX
G – ROYALTY PAYMENT OPTIONS


New
Payment Options Effective March 2018


 


The
License Number MUST appear on payments, reports and correspondence.


 


Credit
and Debit Card Payments: Credit and debit card payments can be submitted for amounts up to $24,999. Submit your payment through the
U.S. Treasury web site located at: https://www.pay.gov/public/form/start/28680443.


 


Automated
Clearing House (ACH) for payments through U.S. banks only


 


The
IC encourages its licensees to submit electronic funds transfer payments through the Automated Clearing House (ACH). Submit your
ACH payment through the U.S. Treasury web site located at: https://www.pay.gov/public/form/start/28680443. Please note
that the IC “only” accepts ACH payments through this


U.S.
Treasury web site.


 


Electronic
Funds Wire Transfers: The following account information is provided for wire payments. In order to process payment via Electronic
Funds Wire Transfer sender MUST supply the following information within the transmission:


 


Drawn
on a U.S. bank account via FEDWIRE:


 


Please
provide the following instructions to your Financial Institution for the remittance of Fedwire payments to the NIH ROYALTY FUND.


 


	Fedwire
    Field Tag	 	Fedwire
    Field Name	 	Required
    Information
	 	 	 	 	 
	{1510}	 	Type/Subtype	 	1000
	{2000}	 	Amount	 	(enter
    payment amount)
	{3400}	 	Receiver
    ABA routing number*	 	021030004
	{3400}	 	Receiver
    ABA short name	 	TREAS
    NYC
	{3600}	 	Business
    Function Code	 	CTR
    (or CTP)
	{4200}	 	Beneficiary
    Identifier (account number)	 	(enter
    12 digit gateway account #)

    875080031006

	{4200}	 	Beneficiary
    Name	 	(enter
    agency name associated with the Beneficiary Identifier)

    DHHS
    / NIH (75080031)

	{5000}	 	Originator	 	(enter
    the name of the originator of the payment)

    COMPANY
    NAME

	{6000}	 	Originator
    to Beneficiary Information – Line 1	 	(enter
    information to identify the purpose of the payment)

    ROYALTY

	{6000}	 	Originator
    to Beneficiary Information – Line 2	 	(enter
    information to identify the purpose of the payment)

    LICENSE
    NUMBER

	{6000}	 	Originator
    to Beneficiary Information – Line 3	 	(enter
    information to identify the purpose of the payment)

    INVOICE
    NUMBER

	{6000}	 	Originator
    to Beneficiary Information – Line 4	 	(enter
    information to identify the purpose of the payment)
	Fedwire
    Field Tag		Fedwire
    Field Name	 	Required
    Information
	Notes:

                                                                     *The financial institution address for Treasury’s routing number is 33 Liberty Street, New York, NY 10045.



 


Agency
Contacts: Office of Technology Transfer (OTT)            (301) 496-7057
             OTT-Royalties@mail.nih.gov


 


Drawn
on a foreign bank account via FEDWIRE:


 


The
following instructions pertain to the Fedwire Network. Deposits made in US Dollars (USD).


 


Should
your remitter utilize a correspondent US domestic bank in transferring electronic funds, the following Fedwire instructions are applicable.


 


	Fedwire
    Field Tag	 	Fedwire
    Field Name	 	Required
    Information
	 	 	 	 	 
	{1510}	 	Type/Subtype	 	1000
	{2000}	 	Amount	 	(enter
    payment amount)
	{3100}	 	Sender
    Bank ABA routing number	 	(enter
    the US correspondent bank’s ABA routing number)
	{3400}	 	Receiver
    ABA routing number*	 	021030004
	{3400}	 	Receiver
    ABA short name	 	TREAS
    NYC
	{3600}	 	Business
    Function Code	 	CTR
    (or CTP)
	{4200}	 	Beneficiary
    Identifier (account number)**	 	(enter
    12 digit gateway account #)

    875080031006

	{4200}	 	Beneficiary
    Name	 	(enter
    agency name associated with the Beneficiary Identifier)

    DHHS
    / NIH (75080031)

	{5000}	 	Originator	 	(enter
    the name of the originator of the payment)

    COMPANY’S
    NAME

	{6000}	 	Originator
    to Beneficiary Information – Line 1	 	(enter
    information to identify the purpose of the payment)

    ROYALTY

	{6000}	 	Originator
    to Beneficiary Information – Line 2	 	(enter
    information to identify the purpose of the payment)

    LICENSE
    NUMBER

	{6000}	 	Originator
    to Beneficiary Information – Line 3	 	(enter
    information to identify the purpose of the payment)

    INVOICE
    NUMBER

	{6000}	 	Originator
    to Beneficiary Information – Line 4	 	(enter
    information to identify the purpose of the payment)
	Notes:

    *The
    financial institution address for Treasury’s routing number is 33 Liberty Street, New York, NY 10045. **Anything other
    than the 12 digit gateway account # will cause the Fedwire to be returned – SWIFT CODE: FRNYUS33



 


Agency
Contacts:


 


Office
of Technology Transfer (OTT)(301) 496-7057OTT-Royalties@mail.nih.gov


 




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Checks


 


All
checks should be made payable to “NIH Patent Licensing”


 


Checks
drawn on a U.S. bank account and sent by US Postal Service should be sent directly to the following address:


 


National
Institutes of Health


P.O.
Box 979071


St.
Louis, MO 63197-9000


 


Checks
drawn on a U.S. bank account and sent by overnight or courier should be sent to the following address:


 


US
Bank


Government
Lockbox SL-MO-C2GL 1005 Convention Plaza


St.
Louis, MO 63101 Phone: 314-418-4087


 


Checks
drawn on a foreign bank account should be sent directly to the following address:


 


National
Institutes of Health


Office
of Technology Transfer


License
Compliance and Administration


Royalty
Administration


6011
Executive Boulevard


Suite
325, MSC 7660


Rockville,
Maryland 20852


 




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