Exhibit
10.1 


 


DEFINITIVE
AGREEMENT


 


INTELLECTUAL
PROPERTY LICENSE AGREEMENT


 


THIS
INTELLECTUAL PROPERTY LICENSE AGREEMENT (the “Agreement”), effective September 30, 2022 (the “Effective Date”),
is entered into by Immune Therapeutics, Inc., a corporation duly organized and existing under the laws of the state of Florida, having
a principal place of business at 2431 Aloma Ave, Winter Park, Florida (herein referred to as IMUN or “Licensee”), and TaiwanJ
Pharmaceuticals a Taiwan corporation having a principal place of business 3F-4, No6-1 Sec2 ShenYi Rd, Chubei, Hsinchu, Taiwan (herein
referred to as “TPEX” or “Licensor”). IMUN and TPEX are sometimes hereinafter referred to as a party (collectively
“Parties”) to this Agreement.


 


RECITALS


 


WHEREAS
Licensor owns certain “Intellectual Property” (as defined below), “Derivative Works” (as defined below),
“Technology” (as defined below), and “Manufacturing Capabilities” (as defined below) relating to the “Product”
(as defined below);


 


WHEREAS
Licensee wishes to obtain, and Licensor is willing to grant, a license to the Property, Derivative Works, Technology, and Manufacturing
Capabilities relating to the Product to the extent set forth herein.


 


NOW
THEREFORE, in consideration of the above recitals and for other good and valuable consideration, the receipt and sufficiency of which
are hereby acknowledged by each of the Parties, the Parties hereto agree as follows:


 


AGREEMENT


 


		1.	Definitions.



 


As
used herein, the following terms shall have the meanings set forth below:


 


		1.1.	“Affiliate”
                                            means any person, organization or entity which is, directly or indirectly, controlling, controlled
                                            by, or under common control with Licensee or Licensor, as the case may be. The term “control”
                                            (including, with correlative meaning, the terms “controlled by” and “under
                                            common control with”), as used with respect to any person or entity, means the possession,
                                            directly or indirectly, of the power to direct or cause the direction of the management and
                                            policies of such person, organization or entity, whether through the ownership of voting
                                            securities, or by contract, or court order, or otherwise. The ownership of voting securities
                                            of a person, organization or entity shall not, in and of itself, constitute “control”
                                            for purposes of this definition, unless said ownership is of a majority of the outstanding
                                            securities entitled to vote of such person, organization or entity. Affiliate shall also
                                            mean a limited partnership in which a subsidiary of IMUN and/or TPEX is a general partner.



 


		1.2.	“Confidential
                                            Information” shall include all information of a Party marked confidential,
                                            restricted, proprietary, or with a similar designation. In addition, the terms and conditions
                                            of this Agreement and all correspondence, information and other materials disclosed during
                                            the negotiation of the Agreement shall be deemed Confidential Information. In addition, with
                                            respect to information of Licensor or any Affiliate of Licensor, the term Confidential Information
                                            shall also include any other information, whether in written, oral, graphic, electronic or
                                            in any other form, including, without limitation, data of Licensor or any Affiliate of Licensor,
                                            software licensed to Licensor or any Affiliate of Licensor, sales, cost and other unpublished
                                            financial information, personnel records, personal information, including of Licensor’,
                                            or any Affiliate of Licensor’, prospective and current customers and employees, product
                                            and business plans, business projections, pricing, and marketing data; business, financial,
                                            technical and information, user manuals, forecasts, analyses, software and processes, which
                                            would be deemed by a reasonable person to be confidential or proprietary in nature.






 


		1.3.	“Derivative
                                            Work” means: any work derived from or based on Intellectual Property or Technology
                                            related to the Product.





 




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		1.4.	“Intellectual
                                            Property” means:



 


		(a)	any
                                            and all proprietary rights provided under (i) patent law, (ii) copyright law, (iii) trademark
                                            law, (iv) design patent or industrial design law, (v) semiconductor chip or mask work law,
                                            or (vi) any other applicable statutory provision or common law principle, including trade
                                            secret law, that may provide a right in ideas, formulae, algorithms, concepts, inventions,
                                            or knowhow, or the expression or use thereof, and including all past, present, and future
                                            causes of action, rights of recovery, and claims for damage, accounting for profits, royalties,
                                            or other relief relating, referring, or pertaining to the Product;



 


		(b)	and
                                            any and all applications, registrations, licenses, sublicenses, agreements, or any other
                                            evidence of a right in the Product.



 


		1.5.	“Field”
                                            means any clinical indication, all uses including therapeutic, prophylactic and diagnostic
                                            applications, in any industry.



 


		1.6.	“Licensee”
                                            has the meaning given to that term in the preamble of this Agreement.



 


		1.7.	“Licensor”
                                            has the meaning given to that term in the preamble of this Agreement.



 


		1.8.	“Royalties”
                                            has the meaning given to that term in Section 4 of this Agreement.



 


		1.9.	“Product”
                                            means any pharmaceutical product including naltrexone or any composition that is a small
                                            molecule, alone or in combination that when formulated and used as a therapeutic in human
                                            beings shows anti-fibrotic, immuno-modulating, and/or anti-inflammatory effects for the treatments
                                            of various diseases, and whose manufacture, use or sale infringes (in the absence of the
                                            license rights granted under this Agreement) a valid claim (which has not been abandoned,
                                            disclaimed or declared invalid in a non-appealable order) included in an issued patent within
                                            the Patent Rights.



 


		1.10.	“Licensed
                                            Territory” means all territories of the world except those listed in Schedule
                                            1.



 


		1.11.	“Patent
                                            Rights” means (a) the patents and the patent applications referred to in Schedule
                                            2 of this Exhibit A; (b) all patents arising from said applications, and all patents and
                                            patent applications based on, claiming the priority date(s) of, or corresponding to any of
                                            the foregoing; or (c) any reissues, extensions (or other governmental actions that provide
                                            exclusive rights to the patent holder in the patented subject matter beyond the original
                                            patent expiration date), substitutions, confirmations, registrations, revalidations, re-examinations,
                                            additions, continuations, continuations-in-part, or divisions of or to any of the foregoing.



 


		1.12.	“Know-How”
                                            means any know-how, trade secret, experimental data, formula, expert opinion, experimental
                                            procedure, and other confidential and/or proprietary information specifically concerning
                                            the Product that is Controlled by TPEX and that is necessary or useful for either: (a) the
                                            formulation, manufacture, use and/or application of the Product; or (b) obtaining registration
                                            of the Product.



 


		1.13.	“Net
                                            Sales” shall be determined in accordance with generally accepted accounting
                                            principles and the usual and customary practices of the parties, and shall mean the gross
                                            amount received by Licensee from a Third Party for Product, less the following:



 


		(a)	the
                                            cost of the applicable Product and other fees paid by Licensee to Licensor;



 


		(b)	any
                                            payment (including, but not limited to, royalties or other license fees) to one or more Third
                                            Parties to obtain a patent license in the absence of which Licensee could not legally make,
                                            import, use, sell, or offer for sale;



 


		(c)	customary
                                            trade, quantity, or cash discounts to the extent actually allowed and taken;



 


		(d)	amounts
                                            repaid or credited by reason of rejection or return;



 


		(e)	any
                                            taxes or other governmental charges levied on the production, sale, transportation, delivery,
                                            or use of a Product which is paid by or on behalf of Licensee; and



 


		(f)	outbound
                                            transportation and distribution costs prepaid or allowed and costs of insurance in transit.



 




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		1.14.	“Third
                                            Parties” means all parties except Licensee, Licensor and their respective Affiliates.



 


		1.15.	“Development
                                            Plan” means Schedule 4 of this Agreement, including any amendments to Schedule
                                            4 made after the Effective Date.



 


		2.	License.



 


		2.1.	License
                                            Grant and Right to Manufacture.



 


		(a)	License
                                            Grant. Licensor hereby grants to Licensee an exclusive, royalty-bearing license, including
                                            the right to grant sublicenses to research, develop, have developed, make, have made, use,
                                            sell, offer for sale, have sold, import, have imported, export and have exported, register,
                                            for the purpose of commercializing the Product in the Licensed Territory, for any and all
                                            uses within the Field, subject to the terms and conditions of this Agreement.



 


		(b)	Right
                                            to Manufacture. Licensor hereby grants Licensee the non-exclusive worldwide right to make
                                            and have made Product under applicable Patent Rights and Know-How relating to processes,
                                            intermediates, and materials for manufacturing Product, and will provide to Licensee without
                                            charge, to the extent available, technical and manufacturing assistance and use of its technology
                                            and proprietary information for the Product, including information on its analytical methods,
                                            validation reports and manufacturing processes. For clarification, the Parties agree that
                                            Licensee’s appointing a Affiliate, Sublicensee, or Third Party to engage in the manufacture
                                            of the Product outside the Licensed Territory for the commercialization of the Product inside
                                            the Territory shall not be deemed a breach of this Agreement.



 


		2.2.	Affiliates.
                                            The license granted to Licensee under Section 2.1 includes the right to have some or
                                            all of Licensee’s rights or obligations under this Agreement exercised or performed
                                            by one or more of Licensee’s Affiliates, on Licensee’s behalf.



 


		2.3.	Sublicenses.



 


Sublicense
Grant. Licensee will be entitled to grant Sublicenses to Third Parties under the license granted pursuant to Section 2.1 subject to the
terms of this Section 2.3. Any such Sublicense shall be on terms and conditions in compliance with and not inconsistent with the terms
of this Agreement. IMUN will pay 30% of sublicense package if the sublicense occurs before completing a clinical trial, 10% if the sublicence
occurs after completing any trial, and 5% if sublicense occurs after any NDA submission.


 


		(a)	Sublicense
                                            Agreements. Licensee shall grant sublicenses pursuant to written agreements, which will be
                                            subject and subordinate to the terms and conditions of this Agreement. Such Sublicense agreements
                                            will contain, among other things, the following:



 


		(i)	all
                                            provisions necessary to ensure Licensee’s ability to perform its obligations under
                                            this Agreement;



 


		(ii)	a
                                            provision clarifying that, in the event of termination of the license set forth in Section
                                            2.1 (in whole or in part (e.g., termination in a particular country)), any existing Sublicense
                                            agreement shall be subject to terminate to the extent of such terminated license;



 




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		(iii)	a
                                            provision prohibiting the Sublicensee from assigning the Sublicense agreement without the
                                            prior written consent of Licensee, except that Sublicensee may assign the Sublicense agreement
                                            to a successor in connection with the merger, consolidation or sale of all or substantially
                                            all of its assets or that portion of its business to which the Sublicense agreement relates.



 


		(b)	Breach
                                            by Sublicensee. Licensee shall notify Licensor of any breach of a Sublicense agreement by
                                            any Sublicensee that results in a material breach of this Agreement. In the event of a breach
                                            by a Sublicensee, the Licensee shall either (a) cure such breach in accordance with such
                                            Sublicense Agreement or (b) enforce its rights by terminating such Sublicense agreement in
                                            accordance with the terms thereof.



 


		2.4.	No
                                            Other Grant of Rights. Except as expressly provided herein, nothing in this Agreement
                                            will be construed to confer any ownership interest, license or other rights to any technology,
                                            intellectual property rights, products or biological materials of one party to the other
                                            that is not specified in this Agreement, unless such rights are necessary to enable the rights
                                            granted in this Agreement.



 


		2.5.	The
                                            license granted pursuant to Section 2.1 shall be revocable only if Licensee has materially
                                            breached of this License Agreement and such breach is continuing for a period of ninety (90)
                                            days after notice thereof given by Licensor or an Affiliate of Licensor to Licensee.



 


		3.	Development
                                            and Commercialization.



 


		3.1.	Diligence.



 


		(a)	Development
                                            Plan. Licensee shall use commercially reasonable efforts and shall cause its Sublicensees
                                            to use commercially reasonable efforts to (a) to develop Licensed Products in accordance
                                            with the Development Plan as detailed in Schedule 4; (b) shall begin commercial sales of
                                            Product the in country no later than eight (8) months after the first registration of Product
                                            in such country; provided, however, that such period shall be extended for as long as commercially
                                            reasonable efforts to begin commercial sales continue. Following commencement of commercial
                                            sales in a country; (c) keep Product reasonably available to the public; provided, however,
                                            that Licensee shall be released from this obligation if supply of Product is not available
                                            for such country or Licensee is not responsible for arranging for the commercial production
                                            and supply of Product for such country.



 


		(b)	Adjustments
                                            to the Development Plan. Licensee will be entitled, from time to time, to make such adjustments
                                            to the then applicable Development Plan as Licensee believes, in its good faith judgment,
                                            are needed in order to improve Licensee’s ability to meet the Development Milestones.



 


		3.2.	Reporting.
                                            Within sixty (60) days after the end of each calendar year, Licensee shall furnish Licensor
                                            with a written report summarizing its, its Affiliates’ and its Sublicensees’
                                            efforts during the prior year to develop and commercialize Products, including: (a) research
                                            and development activities completed; (b) commercialization and/or other distribution efforts,
                                            including significant corporate transactions involving Licensed Products; and (c) marketing
                                            efforts. Each report must contain a sufficient level of detail for Licensor to assess whether
                                            Licensee is in compliance with its obligations under Section 3.1.



 


		3.3.	Failure
                                            to Meet Development Milestone. If Licensee believes that it will not achieve a Development
                                            Milestone, or that Licensee believes there is a superior alternative to achieving the Milestones
                                            as stated in the Agreement, it may notify Licensors in writing in advance of the relevant
                                            deadline. Licensee shall include with such notice (a) a reasonable explanation of the reasons
                                            for the proposed change (“Explanation”) and (b) a reasonably detailed, written
                                            plan for achieving the proposed alternative development plan (“Plan”). If Licensee
                                            so notifies Licensor and provides Licensor with an Explanation and Plan, both of which are
                                            acceptable to Licensor in its reasonable discretion, then Schedule 4 will be amended automatically.
                                            If Licensee so notifies Licensor and provides Licensor with an Explanation and Plan, but
                                            the Explanation is not acceptable to Licensor in its reasonable discretion, then Parties
                                            agree to work expeditiously and in good faith to establish a Development Plan that is mutually
                                            acceptable.



 




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		4.	Consideration
                                            for Grant of License.



 


For
the Term of this Agreement, payment shall be made from Licensee to Licensor in the amounts, at the time, and by the methods listed in
this Section 4.


 


		4.1.	Upfront
                                            Fee. IMUN shall pay TPEX a non-refundable, non-creditable and non-recoverable upfront
                                            payment of five hundred thousand U.S. Dollars ($500,000), within ninety (90) days after the
                                            Effective Date. Within ninety (90) days after the first occurrence of either a) NAFDAC approval
                                            for JKB-122 in Africa for any indication (e.g., NASH, AIH, NAFLD) covered by TPEX patents
                                            in Schedule 2, or b) the enrollment of 1st patient in a FDA trial for Crohn’s Disease,
                                            IMUN shall pay TPEX a non-refundable, non-creditable and non-recoverable license fee of five
                                            hundred thousand U.S. Dollars ($500,000).



 


		4.2.	License
                                            Issuance Grant of Equity. As partial consideration for the license granted hereunder
                                            and pursuant to a mutually-agreeable stock purchase or subscription agreement, within sixty
                                            (60) days after the Effective Date, IMUN shall issue to TPEX a two hundred and fifty thousand
                                            (250,000) shares of IMUN’s common stock (the “Shares”). The Shares shall
                                            have the rights and obligations set forth in the then-effective Certificate of Incorporation
                                            and Bylaws of IMUN. IMUN agrees that it shall grant TPEX, as an owner of common stock of
                                            IMUN, the right to review and enter into any stockholders agreement to the same extent that
                                            any other owner of common stock of IMUN has such rights regarding any such agreement.



 


		4.3.	Annual
                                            License Maintenance Fees. In partial consideration for the rights granted to IMUN, IMUN
                                            will pay $100,000 on the annual anniversary of the Effective Date until such time as IMUN
                                            can demonstrate to TPEX, regulatory approval in Africa.



 


		4.4.	Milestones.
                                            Licensee shall provide to the Licensor the following one-time payments and issuances
                                            of equity.



 


		(a)	Milestone
                                            1. $250,000 US Dollars and 750,000
                                            shares of common stock of IMUN upon the initiation of enrollment of patients in the
                                            first Phase 2b/3 trial for Products in the United States or EU or United Kingdom.



 


		(b)	Milestone
                                            2. $1,000,000 US dollars and 5,000,000
                                            shares of common stock of IMUN upon NDA approval in the United States or EU or United
                                            Kingdom.



 


		(c)	Commercial
                                            Milestone Payment 1. $25,000,000 US dollars
                                            and the number of shares of common stock of IMUN needed to reach a value of $25,000,000
                                            US dollars, the first time that annual sales of Products reach $500,000,000
                                            dollars globally.



 


		(d)	Commercial
                                            Milestone Payment 2. $30,000,000 US dollars
                                            and the number of shares of common stock of IMUN needed to reach a value of $40,000,000
                                            US dollars, the first time that annual sales of Products reach $1,000,000,000
                                            dollars globally.



 




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		4.5.	Royalty
                                            on Net Sales.



 





	 	(a)	Royalty on Net Sales. In any year that a payment as defined in Section 4.4 is not made, Licensee shall pay Licensor an amount equal to the percentage of Net Sales (“Royalty Rate” in table below) that shall be reduced only subject to the conditions set forth in Section 4.5 of this Agreement.	 





 


	Annual Net Sales ($USD) of Licensed Products	Royalty Rate
	<$500,000,000	2%
	500,000,000 to $1,000,000,000	4%
	 >$1,000,000,000)	6%





 


		(b)	Royalty
                                            Obligation. The obligation to pay royalties under this Agreement shall be imposed only once
                                            with respect to any sale of any Product to end users/distributors, and shall not attach with
                                            respect to any intra-company transfers between Licensee’s Affiliates. With respect
                                            to Product in any particular country, Licensee shall only be obligated to pay royalties during
                                            the period during which the sale, offer for sale or importation of such Product in such country
                                            would infringe, but for the license granted herein, a valid claim in a Patent Right included
                                            in Schedule 2 covering such Product in such country.



 


		(c)	Royalty
                                            Stacking. If Licensee reasonably determines in good faith that it is necessary to obtain
                                            either (a) a license from one or more Third Parties to make, have made, use, sell, offer
                                            to sell and/or import Products in the Field in one or more countries in the Territory, which
                                            such license is for a patent reasonably believed by Licensee to dominate one or more claims
                                            of Licensed Patents in existence as of the Effective Date and covering the Licensed Product,
                                            or (b) a license under one or more process patents to make or have made the Licensed Product,
                                            and where, but for such license, Licensee would not be lawfully able to manufacture the Licensed
                                            Product, then in either or both cases, the amount of Licensee’s royalty payments under
                                            this Section 4.5 with respect to Net Sales for such Licensed Product for a given period shall
                                            be reduced by the amount of the payments paid under such other license(s) for that same period;
                                            provided that such Third Party payments are attributable to sales made by Licensee or its
                                            Affiliates or Sublicensees that are used in the calculation of Net Sales which Licensee’s
                                            royalty payment obligation to Licensor is based. Notwithstanding the foregoing, the adjustment
                                            of royalties under this Section 4.5(c) will in no event reduce the royalty rate to less than
                                            50% of the applicable rate set forth in Section 4.5(a).



 


		4.6.	Payment.



 


All
payments due from Licensee under this Agreement will be payable in U.S. dollars and made by wire transfer to a bank and account designated
in writing by Licensor.


 


		5.	Reports;
                                            Payments; Records.



 


		5.1.	Reports.
                                            Within thirty (30) days after the conclusion of each Calendar Quarter commencing with
                                            the first Calendar Quarter in which Net Sales are generated, Licensee shall deliver to Licensor
                                            a report containing the following information (in each instance, with a Product and country-by-country
                                            breakdown):



 


		(a)	the
                                            number of units of Licensed Products sold for the applicable Calendar Quarter;



 


		(b)	the
                                            gross amount received for Licensed Products during the applicable Calendar Quarter;



 




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		(c)	a
                                            calculation of Net Sales for the applicable Calendar Quarter, including an itemized listing
                                            of allowable deductions and the actual selling price;



 


		(d)	the
                                            total amount payable to Licensor in U.S. Dollars on Net Sales and for the applicable Calendar
                                            Quarter, together with the exchange rates used for conversion; and



 


		5.2.	Payment.
                                            Within sixty (60) days after the end of each Calendar Quarter, Licensee shall pay Licensor
                                            all amounts due with respect to Net Sales for the applicable Calendar Quarter.



 


		5.3.	Payment
                                            Currency. All payments due under this Agreement will be paid in U.S. Dollars. Conversion
                                            of foreign currency to U.S. Dollars will be made at the conversion rate existing in the United
                                            States (as reported in the Wall Street Journal) on the last business day of the applicable
                                            Calendar Quarter. Such payments will be without deduction of exchange, collection or other
                                            charges.



 


		5.4.	Records.
                                            Licensee shall maintain, and shall cause its Affiliates and Sublicensees to maintain,
                                            complete and accurate records of Licensed Products that are made, used, sold, leased or transferred
                                            under this Agreement, any amounts payable to Licensor in relation to such Licensed Products,
                                            which records shall contain sufficient information to permit Licensor to confirm the accuracy
                                            of any reports or notifications delivered to Licensor under Section 5. Licensee, its Affiliates
                                            and/or its Sublicensees, as applicable, shall retain such records relating to a given Calendar
                                            Quarter for at least three (3) years after the conclusion of that Calendar Quarter, during
                                            which time Licensor will have the right, at its expense, to cause an independent, certified
                                            public accountant to inspect such records during normal business hours for the purposes of
                                            verifying the accuracy of any reports and payments delivered under this Agreement and Licensee’s
                                            compliance with the terms hereof. Such accountant or other auditor, as applicable, shall
                                            not disclose to Licensor any information other than information relating to the accuracy
                                            of reports and payments delivered under this Agreement. The parties shall reconcile any underpayment
                                            or overpayment within thirty (30) days after the accountant delivers the results of the audit.
                                            Licensor may exercise its rights under this Section 5.4 only once every year and only with
                                            reasonable prior notice to Licensee.



 


		5.5.	Late
                                            Payments. Any payments by Licensee that are not paid on or before the date such payments
                                            are due under this Agreement will bear interest at the lower of (a) one and one half percent
                                            (1.5%) per month and (b) the maximum rate allowed by law. Interest will accrue beginning
                                            on the first day following the due date for payment and will be compounded quarterly. Payment
                                            of such interest by Licensee shall limit the right to exercise any other remedies Licensor
                                            may have as a consequence of the lateness of any payment.



 


		5.6.	Payment
                                            Method. Each payment due to Licensor under this Agreement shall be paid by check or wire
                                            transfer of funds to Licensor’s account in accordance with written instructions provided
                                            by Licensor.



 


		5.7.	Withholding
                                            and Similar Taxes. All amounts to be paid to TPEX pursuant to this Agreement shall be
                                            without deduction of exchange, collection, or other charges, and, specifically, without deduction
                                            of withholding or similar taxes or other government imposed fees or taxes, except as permitted
                                            in the definition of Net Sales.



 


		6.	Patent
                                            Filing, Prosecution and Maintenance. 



 


		6.1.	Control.
                                            Licensor will be responsible for the preparation, filing, prosecution, protection, defense
                                            and maintenance of all Patent Rights, using independent patent counsel reasonably acceptable
                                            to Licensee. Licensor will: (a) instruct such patent counsel to furnish the Licensee with
                                            copies of all correspondence relating to the Patent Rights from the United States Patent
                                            and Trademark Office (USPTO) and any other patent office, as well as copies of all proposed
                                            responses to such correspondence in time for Licensee to review and comment on such response;
                                            (b) give Licensee an opportunity to review the text of each patent application before filing;
                                            (c) consult with Licensee with respect thereto; (d) supply Licensee with a copy of the application
                                            as filed, together with notice of its filing date and serial number; and (e) keep Licensee
                                            advised of the status of actual and prospective patent filings. Licensor shall give Licensee
                                            the opportunity to provide comments on and make requests of Licensor concerning the preparation,
                                            filing, prosecution, protection, defense and maintenance of the Patent Rights, and shall
                                            seriously consider such comments and requests; however, final decision-making authority shall
                                            vest in Licensor.



 




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		6.2.	Expenses.
                                            Subject to Section 6.3 below, should Licensor incur expenses pursuant to Article 6 that
                                            benefit the Licensee but have no benefit to the Licensor, as agreed to in writing by Parties,
                                            Licensee shall reimburse Licensor for all such documented expenses incurred by Licensor pursuant
                                            to this Article 6 within thirty (30) days after the date of each invoice from Licensor for
                                            such expenses. In addition, within thirty (30) days after the Effective Date, Licensee shall
                                            reimburse Licensor for all documented, out-of-pocket expenses incurred by Licensor prior
                                            to the Effective Date with respect to the preparation, filing, prosecution, protection and
                                            maintenance of Patent Rights.



 


		6.3.	Abandonment.
                                            If Licensor decides that it does not wish to pay for the prosecution or maintenance of
                                            any Patent Rights in a particular country that is in the Licensed Territory, Licensor shall
                                            provide Licensee with prompt written notice of such election. Upon receipt of such notice
                                            by Licensor, Licensee a) shall be released from its obligation to reimburse Licensor for
                                            any payments otherwise due to Licensor as a result of its election to discontinue such prosecution
                                            or maintenance of Patent Rights, and b) Licensor shall assign Control to Licensee prior to
                                            abandonment so that it may, at the sole discretion of Licensee, continue to pay for the prosecution
                                            or maintenance of any such Patent Rights that are assigned.



 


		6.4.	Marking.
                                            Licensee shall, and shall cause its Affiliates and Sublicensees to, mark all Licensed
                                            Products sold or otherwise disposed of in such a manner as to conform with the patent laws
                                            and practice of the country to which such products are shipped or in which such products
                                            are sold for purposes of ensuring maximum enforceability of Patent Rights in such country.



 


		7.	7.
                                            Enforcement of Patent Rights. 



 


		7.1.	Notice.
                                            In the event either party becomes aware of any possible or actual infringement of any Patent
                                            Rights with respect to Licensed Products in the Field [and in the Territory] (an “Infringement”),
                                            that party shall promptly notify the other party and provide it with details regarding such
                                            Infringement.



 


		7.2.	Suit
                                            by Parties.



 


		(a)	Licensor
                                            shall have the first right, but not the obligation, to take action in the prosecution, prevention,
                                            or termination of any Infringement that is not included in the Licensed Territory. Before
                                            Licensor commences an action with respect to any Infringement, Licensor shall consider in
                                            good faith the views of Licensee in making its decision whether to sue. Should Licensor elect
                                            to bring suit against an infringer, Licensor shall keep Licensee reasonably informed of the
                                            progress of the action and shall give Licensee a reasonable opportunity in advance to consult
                                            with Licensor and offer its views about major decisions affecting the litigation. Licensor
                                            shall give careful consideration to those views, but shall have the right to control the
                                            action.



 


		(b)	Licensee
                                            shall have the first right, but not the obligation, to take action in the prosecution, prevention,
                                            or termination of any Infringement in the Licensed Territory. Before Licensee commences an
                                            action with respect to any Infringement, Licensee shall consider in good faith the views
                                            of Licensor in making its decision whether to sue. Should Licensee elect to bring suit against
                                            an infringer, Licensee shall keep Licensor reasonably informed of the progress of the action
                                            and shall give Licensor a reasonable opportunity in advance to consult with Licensee and
                                            offer its views about major decisions affecting the litigation. Licensee shall give careful
                                            consideration to those views, but shall have the right to control the action.



 


		7.3.	Any
                                            and all expenses incurred by either the Licensor or the Licensee with respect to the prosecution,
                                            adjudication and/or settlement of such suit, including any related appeals, shall be paid
                                            for entirely by the Party that elected to bring suit and shall hold the other Party free,
                                            clear and harmless from and against any and all such expenses



 




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		7.4.	Own
                                            Counsel. Each party shall always have the right to be represented by counsel of its own
                                            selection and at its own expense in any suit instituted under this Article 7 by the other
                                            party for Infringement.



 


		7.5.	Cooperation.
                                            Each party agrees to cooperate fully in any action under this Article 7 that is controlled
                                            by the other party, provided that the controlling party reimburses the cooperating party
                                            promptly for any costs and expenses incurred by the cooperating party, including reasonable
                                            attorneys’ fees, in connection with providing such assistance.



 


		7.6.	Declaratory
                                            Judgment. If a declaratory judgment action is brought naming Licensee and/or any of its Affiliates
                                            or Sublicensees as a defendant and alleging invalidity or unenforceability of any claims
                                            within the Patent Rights, Licensee shall promptly notify Licensor in writing and Licensor
                                            shall, upon written notice to Licensor within thirty (30) days after Licensor receives notice
                                            of the commencement of such action, will take over the sole defense of the invalidity and/or
                                            unenforceability aspect of the action at its own expense.



 


		8.	Warranties;
                                            Limitation of Liability.



 


		8.1.	Compliance
                                            with Law. Licensee represents and warrants that it will comply, and will ensure that
                                            its Affiliates and Sublicensees comply, with all local, state, federal and international
                                            laws and regulations relating to the development, manufacture, use, sale, and importation
                                            of Products. Without limiting the foregoing, Licensee represents and warrants, on behalf
                                            of itself and its Affiliates and Sublicensees, that they shall comply with all United States
                                            laws and regulations controlling the export of certain commodities and technical data, including
                                            without limitation all Export Administration Regulations of the United States Department
                                            of Commerce. Among other things, these laws and regulations prohibit or require a license
                                            for the export of certain types of commodities and technical data to specified countries.
                                            Licensee hereby gives written assurance that it will comply with, and will cause its Affiliates
                                            and Sublicensees to comply with, all United States export control laws and regulations, that
                                            it bears sole responsibility for any violation of such laws and regulations by itself or
                                            its Affiliates or Sublicensees, and that it will indemnify, defend, and hold the Indemnitees
                                            harmless (in accordance with Section 9.1 below) for the consequences of any such violation.



 


		8.2.	Limitation
                                            of Liability. 



 


		(a)	Party’s
                                            will not be liable to the other Party, its Affiliates, any Sublicensee, or any of their Affiliates
                                            with respect to any subject matter of this Agreement under any contract, negligence, strict
                                            liability or other legal or equitable theory for (a) any indirect, incidental, consequential
                                            or punitive damages or lost profits or (b) cost of procurement of substitute goods, technology
                                            or services.



 


		(b)	Either
                                            Party’s aggregate liability for all damages of any kind arising out of or relating
                                            to this Agreement or its subject matter under any contract, negligence, strict liability
                                            or other legal or equitable theory shall not exceed the amounts paid under this Agreement.



 


		9.	Indemnification.



 


		9.1.	Indemnity.



 


		(a)	Parties
                                            shall indemnify, defend and hold harmless each other and their respective agents (collectively,
                                            the “Indemnitees”) from and against any claim, liability, cost, expense, damage,
                                            deficiency, loss or obligation of any kind or nature (including reasonable attorneys’
                                            fees and other costs and expenses of litigation), based upon, arising out of, or otherwise
                                            relating to this Agreement or any Sublicense, including any cause of action relating to product
                                            liability concerning any product, process, or service made, used, sold or performed pursuant
                                            to any right or license granted under this Agreement (collectively, “Claims”).
                                            Neither Licensee nor Licensor shall settle any Claim without the prior written consent of
                                            the other, which consent shall not be unreasonably withheld.



 




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		(b)	Parties
                                            shall, at its their own expense, provide attorneys reasonably acceptable to the other Party
                                            to defend against any actions brought or filed against any Indemnitee hereunder with respect
                                            to the subject of indemnity contained herein, whether or not such actions are rightfully
                                            brought.



 


		10.	Term
                                            and Termination.



 


		10.1.	Term.
                                            The term of this Agreement shall commence on the Effective Date and, unless earlier terminated
                                            as provided in this Article 10, shall continue in full force and effect until the expiration
                                            of the last to expire Valid Claim (the “Term”).



 


		10.2.	Termination.



 


		(a)	Termination
                                            Without Cause. Licensee may terminate this Agreement upon sixty (60) days prior written notice
                                            to Licensor.



 


		(b)	Termination
                                            for Default. In the event that either party commits a material breach of its obligations
                                            under this Agreement and fails to cure that breach within ninety (90) days after receiving
                                            written notice thereof, the other party may terminate this Agreement immediately upon written
                                            notice to the party in breach.



 


		10.3.	Effect
                                            of Termination. 



 


		(a)	Termination
                                            of Rights. Upon expiration or termination of this Agreement by either party pursuant to any
                                            of the provisions of Section 10.2(a) above the rights and licenses granted to Licensee under
                                            Article 2 shall terminate, all rights in and to and under the Patent Rights will revert to
                                            Licensor and neither Licensee nor its Affiliates may make any further use or exploitation
                                            of the Patent Rights; and (b) any existing agreements that contain a Sublicense shall terminate
                                            to the extent of such Sublicense; provided, however, that, for each Sublicensee, upon termination
                                            of the Sublicense agreement with such Sublicensee, if the Sublicensee is not then in breach
                                            of its Sublicense agreement with Licensee such that Licensee would have the right to terminate
                                            such Sublicense, such Sublicensee shall have the right to seek a license from Licensor. Licensor
                                            agrees to negotiate such licenses in good faith under reasonable terms and conditions, which
                                            shall not impose any representations, warranties, obligations or liabilities on Licensor
                                            that are not included in this Agreement.



 


		(b)	Accruing
                                            Obligations. Termination or expiration of this Agreement shall not relieve the parties of
                                            obligations accruing prior to such termination or expiration, including obligations to pay
                                            amounts accruing hereunder up to the date of termination or expiration. After the date of
                                            termination or expiration (except in the case of termination by Licensor pursuant to Section
                                            10.2), Licensee, its Affiliates and Sublicensees (a) may sell Products then in stock and
                                            (b) may complete the production of Products then in the process of production and sell the
                                            same; provided that, in the case of both (a) and (b), Licensee shall pay the applicable royalties
                                            and payments to Licensor in accordance with Article 4, provide reports to Licensor pursuant
                                            to Article 5.



 




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		(c)	Regulatory
                                            Filings. Licensee shall have the exclusive right to prepare and present all regulatory filings
                                            necessary or appropriate in any country and to obtain and maintain any regulatory approval
                                            required to market Products in any such country. Licensee shall solely own all right, title
                                            and interest in and to all such regulatory approvals and filings; provided, however, that
                                            in the event Licensee terminates this Agreement pursuant to Section 10.2(a), Licensor may
                                            request that Parties enter into good faith negotiations that, upon agreement, would grant
                                            Licensor or a licensee of the Licensor with the right to reference, cross-reference, review,
                                            have access to, incorporate and use all documents and other materials filed by or on behalf
                                            of Licensee and its Affiliates with any Regulatory Authority in furtherance of applications
                                            for regulatory approval in the relevant country with respect to Products.



 


		10.4.	Survival.
                                            The parties’ respective rights, obligations and duties under Section 4, 5, 8, 9,
                                            10 and 11, as well as any rights, obligations and duties which by their nature extend beyond
                                            the expiration or termination of this Agreement, shall survive any expiration or termination
                                            of this Agreement.



 


		11.	Miscellaneous.



 


		11.1.	Entire
                                            Agreement. This Agreement is the sole agreement with respect to the subject matter hereof
                                            and except as expressly set forth herein, supersedes all other agreements and understandings
                                            between the parties with respect to the same.



 


		11.2.	Notices.
                                            Unless otherwise specifically provided, all notices required or permitted by this Agreement
                                            shall be in writing and may be delivered personally, or may be sent by facsimile, expedited
                                            delivery or certified mail, return receipt requested, to the following addresses, unless
                                            the Parties are subsequently notified of any change of address in accordance with this Section:



 




If to Licensee: [COMPLETE IN EXECUTION COPY]



If to Licensor: [COMPLETE IN EXECUTION COPY]



Any notice shall be deemed to have been received as follows: (a) by personal delivery or expedited delivery, upon receipt; (b) by facsimile,
one business day after transmission or dispatch; (c) by certified mail, as evidenced by the return receipt. If notice is sent by facsimile,
a confirming copy of the same shall be sent by mail to the same address.


 


		11.3.	Governing
                                            Law and Jurisdiction. This Agreement will be governed by, and construed in accordance
                                            with, the substantive laws of the United States and the State of incorporation of the Licensee
                                            (the “State”), without giving effect to any choice or conflict of law provision,
                                            except that questions affecting the construction and effect of any patent shall be determined
                                            by the law of the country in which the patent shall have been granted. Any action, suit or
                                            other proceeding arising under or relating to this Agreement (a “Suit”) shall
                                            be brought in a court of competent jurisdiction in the State, and the parties hereby consent
                                            to the sole jurisdiction of the state and federal courts sitting in the St Each party agrees
                                            not to raise any objection at any time to the laying or maintaining of the venue of any Suit
                                            in any of the specified courts, irrevocably waives any claim that Suit has been brought in
                                            any inconvenient forum and further irrevocably waives the right to object, with respect to
                                            any Suit, that such court does not have any jurisdiction over such party.



 


		11.4.	Binding
                                            Effect. This Agreement shall be binding upon and inure to the benefit of the parties
                                            and their respective legal representatives, successors and permitted assigns.



 


		11.5.	Headings.
                                            Article, Section and subsection headings are inserted for convenience of reference only and
                                            do not form a part of this Agreement.



 


		11.6.	Counterparts.
                                            The parties may execute this Agreement in two or more counterparts, each of which shall
                                            be deemed an original, but both of which together shall constitute one and the same instrument.
                                            Transmission by facsimile or electronic mail of an executed counterpart of this Agreement
                                            shall be deemed to constitute due and sufficient delivery of such counterpart. If by electronic
                                            mail, the executed Agreement must be delivered in a .pdf format.



 




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	 	11.7.	Amendment;
    Waiver. This Agreement may be amended, modified, superseded or canceled, and any of the terms may be waived, only by a written
    instrument executed by each party or, in the case of waiver, by the party waiving compliance. The delay or failure of either party
    at any time or times to require performance of any provisions hereof shall in no manner affect the rights at a later time to enforce
    the same. No waiver by either party of any condition or of the breach of any term contained in this Agreement, whether by conduct,
    or otherwise, in any one or more instances, shall be deemed to be, or considered as, a further or continuing waiver of any such condition
    or of the breach of such term or any other term of this Agreement.
	 	 	 
	 	11.8.	No
    Agency or Partnership. Nothing contained in this Agreement shall give either party the right to bind the other, or be deemed
    to constitute either party as agent for or partner of the other or any third party.
	 	 	 
	 	11.9.	Assignment
    and Successors. This Agreement may not be assigned by either party without the consent of the other, which consent shall not
    be unreasonably withheld, except that each party may, without such consent, assign this Agreement and the rights, obligations and
    interests of such party to any purchaser of all or substantially all of its assets or all of its equity, or to any successor corporation
    resulting from any merger or consolidation of such party with or into such corporation; provided, in each case, that the assignee
    agrees in writing to be bound by the terms of this Agreement.
	 	 	 
	 	11.10.	Force
    Majeure. Except for monetary obligations hereunder, neither party will be responsible for delays resulting from causes beyond
    the reasonable control of such party, including fire, explosion, flood, war, strike, or riot, provided that the nonperforming party
    uses commercially reasonable efforts to avoid or remove such causes of nonperformance and continues performance under this Agreement
    with reasonable dispatch whenever such causes are removed.
	 	 	 
	 	11.11.	Interpretation.
    Each party hereto acknowledges and agrees that: (a) it and/or its counsel reviewed and negotiated the terms and provisions of
    this Agreement and has contributed to its revision; (b) the rule of construction to the effect that any ambiguities are resolved
    against the drafting party shall not be employed in the interpretation of this Agreement; (c) the terms and provisions of this Agreement
    shall be construed fairly as to both parties hereto and not in favor of or against either party, regardless of which party was generally
    responsible for the preparation of this Agreement; and (d) the use of “include,” “includes,” or “including”
    herein shall not be limiting and “or” shall not be exclusive.
	 	 	 
	 	11.12.	Severability.
    If any provision of this Agreement is or becomes invalid or is ruled invalid by any court of competent jurisdiction or is deemed
    unenforceable, it is the intention of the parties that the remainder of this Agreement shall not be affected.


 


	 	12.	Intellectual
    Property


 


	 	12.1.	The
    Intellectual Property related to the Product is proprietary to Parties, and is protected by applicable law, including United States
    patent, copyright, trade secret and/or trademark law. Parties acknowledge that Intellectual Property and Know-How related to the
    Product may include trade secrets of Licensor. Licensee acknowledges and agrees that except for derivative works created by or at
    the direction of Licensee pursuant to the terms of this Agreement (a) Licensor shall own all right, title and interest in and to
    the Product’s trade secrets, (b) Licensee’s use of the Intellectual Property related to the Product will not create in
    it, nor will it represent that it has, any right, title or interest in or to any Intellectual Property related to the Product other
    than the license expressly granted herein. Parties shall use all reasonable efforts to: (i) preserve and protect Licensor’s
    Intellectual Property related to the Product provided to Licensee and used by Licensee hereunder; (ii) notify Licensor of any action
    by any third party known by Licensee to constitute an infringement of Licensor’s intellectual property rights described herein;
    and (iii) reasonably cooperate with Licensor in protecting such intellectual property rights.


 




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	 	12.2.	Development
    Plan Data and Results. All rights, title, and interest in and to any data and results generated in performance of the Development
    Plan shall be owned by Licensee. Use of Research Data shall be governed by and subject to the terms of Schedule 4.
	 	 	 
	 	12.3.	Existing
    Intellectual Property; No Implied License. The Parties acknowledge and agree that neither party transfers by operation of this
    Agreement to the other party any intellectual property rights owned prior to or as of the Effective Date hereof or generated outside
    of the scope of this Agreement. No license to either Party’s preexisting intellectual property or intellectual property generated
    outside the scope of this Agreement is granted to the other Party under this Agreement.
	 	 	 
	 	12.4.	Arising
    Inventions. As used in this Agreement, the term “Arising Invention” means any information, inventions, innovations,
    ideas, discoveries, or products (whether or not copyrightable or patentable), suggestions, communications, correspondence, evaluations,
    work product and results which are conceived, derived, reduced to practice, made or developed as a result of conducting the Development
    Plan or that use or incorporate a Party’s Confidential Information (defined below).
	 	 	 
	 	12.5.	Ownership.
    Inventorship of Arising Inventions shall be determined in accordance with United States intellectual property laws. Notwithstanding
    the foregoing, Arising Inventions, whether or not patentable, shall be jointly owned by Parties; provided, however, that in the case
    of Arising Inventions that occur during the performance of the Development Plan, Licensee shall have the first right and opportunity
    to conduct the prosecution of any patent rights associated with any Arising Invention, in its discretion, taking into account recommendations
    made by Licensor, if any. If the Licensor shall consent (such consent not to be unreasonably withheld, delayed or conditioned) to
    any such prosecution, the costs of such prosecution shall be shared equally between the Parties and both Parties will reasonably
    execute all documents and provide all reasonable non-financial support in the filing and prosecution of any such patents. If one
    party does not consent to any such prosecution, or agree to share the costs of such prosecution, Parties agree to reasonably execute
    all documents and provide all reasonable non-financial support in the filing and prosecution of any such patents.


 


	 	13.	Representations
    and Disclaimer of Warranties


 


	 	13.1.	NOTHING
    IN THIS AGREEMENT SHALL BE DEEMED TO BE A REPRESENTATION OR WARRANTY BY LICENSOR OF THE VALIDITY OF ANY OF THE INTELLECTUAL PROPERTY
    OR KNOW HOW RELATED TO THE PRODUCT. LICENSOR SHALL HAVE NO LIABILITY WHATSOEVER TO LICENSEE OR ANY OTHER PERSON FOR OR ON ACCOUNT
    OF ANY INJURY, LOSS, OR DAMAGE, OF ANY KIND OR NATURE SUSTAINED BY, OR ANY DAMAGE ASSESSED OR ASSERTED AGAINST, OR ANY OTHER LIABILITY
    INCURRED BY OR IMPOSED UPON LICENSEE OR ANY OTHER PERSON, ARISING OUT OF OR IN CONNECTION WITH OR RESULTING FROM (A) THE PRODUCTION,
    USE, OR SALE OF ANY PRODUCT, OR THE PRACTICE OF THE INTELLECTUAL PROPERTY RIGHTS; OR (B) ANY ADVERTISING OR OTHER PROMOTIONAL ACTIVITIES
    WITH RESPECT TO ANY OF THE FOREGOING, AND LICENSEE SHALL HOLD LICENSOR, AND ITS OFFICERS, AGENTS, OR EMPLOYEES, HARMLESS IN THE EVENT
    LICENSOR, OR ITS OFFICERS, AGENTS, OR EMPLOYEES, IS HELD LIABLE.


 


	 	14.	Termination


 


	 	14.1.	This
    Agreement shall terminate upon the occurrence of any of the following events:


 


	 	(a)	the
    dissolution of Licensee; or
	 	 	 
	 	(b)	upon
    the default by either Party of any obligation hereunder, or the adjudication of bankruptcy, insolvency or the making of an assignment
    for the benefit of creditors, placement in the hands of a receiver or a trustee in bankruptcy of a Party, in each case, upon sixty
    (60) days’ notice by Registered Mail by the non-defaulting, bankrupt or insolvent Party to the defaulting, bankrupt or involvement
    Party, and failure by such Party to remedy the condition that is the basis for termination within such sixty (60) day period.


 




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	 	14.2.	The
    word “termination” and cognate words, such as “term” and “terminate,” used in this Section 14
    and elsewhere in this Agreement are to be read, except where the contrary is specifically indicated, as omitting from their effect
    the following rights and obligations, all of which survive any termination to the degree necessary to permit their complete fulfillment
    or discharge:


 


	 	(a)	Any
    cause of action or claim of a Party accrued, or to accrue, because of any breach or default by the other Party; or
	 	 	 
	 	(b)	The
    representation and disclaimer of warranties of Section 13.


 


	 	15.	Assignability


 


The
Parties agree that each may assign any right under this Agreement not specifically prohibited by its terms without the written consent
of other. If one party wishes to assign any right under this Agreement that is prohibited by terms of this Agreement, Parties agree to
work in good faith to negotiate a mutually acceptable amendment to this Agreement to allow such an assignment.


 


	 	16.	Confidentiality


 


	 	16.1.	Treatment
    of Confidential Information. Each Party agrees as follows:


 


	 	(a)	Confidential
    Information. The parties may provide technical information, documentation and expertise to each other that is either (1) marked as
    being confidential or, (2) if delivered in oral form is identified as being confidential (“Confidential Information”).
    The receiving party shall for a period of five (5) years from the date of disclosure (i) hold the disclosing party’s Confidential
    Information in strict confidence, and (ii), except as previously authorized in writing by the disclosing party, not publish or disclose
    the disclosing party’s Confidential Information to anyone other than the receiving party’s employees on a need-to-know
    basis, and (iii) use the disclosing party’s Confidential Information solely for performance of this Agreement. The foregoing
    requirement shall not apply to any portion of a party’s Confidential Information which (a) becomes publicly known through no
    wrongful act or omission on the part of the receiving party; (b) is already known to the receiving party at the time of the disclosure
    without similar nondisclosure obligations; (c) is rightfully received by the receiving party from a third party without similar nondisclosure
    obligations; (d) is approved for release by written authorization of the disclosing party; (e) is clearly demonstrated by the receiving
    party to have been independently developed by the receiving party without access to the disclosing party’s Confidential Information;
    or (f) is required to be disclosed by order of a court or governmental body or by applicable law, provided that the party intending
    to make such required disclosure shall promptly notify the other party of such intended disclosure in order to allow such party to
    seek a protective order or other remedy.
	 	 	 
	 	(b)	Each
    Party shall use commercially reasonable efforts to maintain the confidentiality of the other Party’s Confidential Information,
    which shall be at least the same efforts as it uses to maintain the confidentiality of its own Confidential Information, and as otherwise
    required under applicable laws;
	 	 	 
	 	(c)	Each
    Party may disclose or provide access to Confidential Information to its responsible employees who have a need to know and may make
    copies of Confidential Information, but only to the extent reasonably necessary to carry out its obligations hereunder; and
	 	 	 
	 	(d)	Each
    Party may disclose or provide access to Confidential Information to its consultants, auditors, accountants, and attorneys if such
    consultants, auditors, accountants and attorneys have entered into confidentiality agreements with the Party covering such information
    or such consultants, auditors, accountants, and attorneys are otherwise required to maintain the confidentiality of such information,
    and only to the extent that such disclosure is necessary for the performance of its duties and obligations or the preservation of
    its rights or remedies under this Agreement.


 




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	 	(e)	In
    addition, Parties shall maintain in effect and enforce, rules and policies to protect against access to or use or disclosure of Confidential
    Information other than in accordance with this Agreement, including written instruction to, and agreements with, employees and agents
    to ensure that such employees and agents protect the confidentiality of Confidential Information.


 


	 	16.2.	Exclusions.
    Confidential Information shall not include information that (i) is in or enters the public domain without breach of this Agreement,
    (ii) the receiving Party receives from a third Party without restriction on disclosure and without breach of a nondisclosure obligation,
    or (iii) the receiving Party knew prior to receiving such information from the disclosing Party or develops independently without
    reference to the disclosing Party’s Confidential Information. The foregoing exclusions shall not apply to information that
    is required to be maintained on a confidential basis by applicable laws.
	 	 	 
	 	16.3.	Required
    Disclosures. A Party shall not be considered to have breached its obligations by disclosing Confidential Information of the other
    Party in accordance with, and to the extent required by, applicable Law or to satisfy any lawful request by a governmental authority
    having competent jurisdiction over the disclosing Party; provided, that immediately upon receiving any such request and to the extent
    that it may legally do so, such Party so notifies the other Party in writing, and if possible, such Party will provide the other
    Party with notice not less than five (5) business days prior to the required disclosure. The disclosing Party shall use reasonable
    efforts not to release Confidential Information pending the outcome of any measures taken by the other Party to contest, otherwise
    oppose or seek to limit such disclosure by the disclosing Party and any subsequent disclosure or use of Confidential Information
    that may result from such disclosure. The disclosing Party shall cooperate with the other Party regarding such measures. Notwithstanding
    any disclosure, the disclosing Party’s obligations hereunder with respect to Confidential Information so disclosed shall remain
    in full force and effect.
	 	 	 
	 	16.4.	Obligations
    Upon Disclosure. In the event of any unauthorized possession, use, disclosure (or attempt thereof), or loss of, or inability
    to account for, any Confidential Information of the furnishing Party, the receiving Party shall promptly, at its own expense: (a)
    notify the furnishing Party in writing of the full details of such unauthorized possession, use, disclosure or loss of, or inability
    to account for, such Confidential Information; (b) take such actions at its cost and expense required to comply with the Law and
    as may be necessary or reasonably requested by the furnishing Party to minimize the violation; (c) cooperate in all reasonable respects
    with the furnishing Party to minimize the violation and any damage resulting therefrom; and (d) provide the furnishing Party with
    assurance satisfactory to the furnishing Party that such breach shall not recur.
	 	 	 
	 	16.5.	Injunctive
    Relief. The Parties acknowledge and agree that monetary damages may be inadequate to compensate for a breach of the provisions
    contained in the confidentiality provisions of this Agreement. In the event of such breach, the injured Party may be entitled to
    seek injunctive relief and other remedies available at law or in equity. In the event the injured Party makes a claim to obtain any
    injunctive relief, the other Party shall not contend that monetary damages are a sufficient remedy and shall not require that the
    injured Party post a bond. The foregoing is subject to the court’s finding as to the merits of the injured Party’s request
    for such injunctive relief. This Section in no way limits the liability or damages that may be assessed against a Party in the event
    of a breach by the other Party of any of the provisions of this Section.
	 	 	 
	 	16.6.	Execution
    and Counterparts. This Agreement may be executed in counterparts and also by facsimile, scan, or other electronic means (e.g.,
    DocuSign), and each counterpart, facsimile or electronic copy shall have the same force and effect as an original and shall constitute
    an effective, binding agreement on the part of each of the undersigned.


 


[Remainder
of page intentionally left blank.]


 




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IN
WITNESS WHEREOF the Parties have caused this Agreement to be executed by their duly authorized officers as of the date first written
above.


 


LICENSOR


 


	TaiwanJ
    Pharmaceuticals	 
	 	 	 
	By:
    	               	 
	Name:	 	 
	Title:	 	 



 


	

    Address:

    
 	 	 
	 	 	 
	Email:	 	 


 


LICENSEE


 


	Immune
    Therapeutics, Inc.	 
	 	 	 
	By:
    	 	 
	Name:	Stephen Wilson, PhD	 
	Title:
    	CEO and President	 



 


	Address:	 	 


 


Email:
steve.wilson@immunetherapeutics.com


 




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SCHEDULE
1: TERRITORITIES EXCLUDED FROM LICENSED TERRITORY


 


Any
countries or territories in Asia, and;


 


Any
countries or territories barred or sanctioned by the United States Government.


 




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SCHEDULE
2: PATENTS AND PATENT APPLICATIONS


 


	 	A.	Patent
    applications in relation to the composition of matter.


 


	Country	 	Application
    No.	 	Title
	USA	 	16/966,645	 	Pharmaceutical
    formulation for a solid dosage form of opioid receptor antagonists


 


	 	B.	Patents
    and patent applications in relation to the primary indication of use.


 


	






	Multiple
    Indications
	 
	Country	 	Application
    No.	 	Patent
    No.	 	Patent
    Term	 	Utility
    Claim
	Taiwan	 	092132155	 	I275591	 	2003/11/17
    ~ 2023/11/16	 	Organ
    Damage (Liver, Kidney, Lung Damage)
	Taiwan	 	095146643	 	I430992	 	2003/11/17
    ~ 2023/11/16	 	Rheumatoid
    arthritis, Organ damage (Liver or kidney damages), Crohn’s Disease, Ulcerative colitis, Multiple sclerosis
	Hong
    Kong	 	14104476.9	 	HK1192711

    (License
    out)

    官網資訊專利所有人為TAIWANJ

    PHARMACEUTICALS
    CO., LTD (2022/4/20瀏覽)
	 	2003/05/16
    ~ 2023/05/16	 	Organ
    Damage (Liver, Kidney, Lung Damages), Liver damage caused by alcohol abuse, hepatitis, cirrhosis, bacterial infection or environment
    toxins
	India	 	3435/DELP/2004	 	IN240229

    (License
    out)

    官網沒有從TAIWANJ
    讓渡出去的文件

    (2022/4/20瀏覽)
	 	2003/05/16
    ~ 2023/05/16	 	Organ
    Damage (Liver, Kidney, Lung Damages), Liver damage caused by alcohol abuse, hepatitis, cirrhosis, bacterial infection or environment
    toxins
	Japan	 	20040505341	 	JP5438250

    (License
    out)

    官網資訊權利者為タイワンジェ

     ファーマシュティカルズ

     カンパニー リミテッド

    (2022/4/20瀏覽)
	 	2003/05/16
    ~ 2023/05/16	 	Liver
    and kidney damages associated with overproduction of TNF-α
	Singapore	 	2004063871	 	SG108388

    (License
    out)

    官網資訊專利所有人為TAIWANJ

    PHARMACEUTICALS
    CO., LTD (2022/4/20瀏覽)
	 	2003/05/16
    ~ 2023/05/16	 	Organ
    Damage (Liver, Kidney, Lung Damages), Liver damage caused by alcohol abuse, hepatitis, cirrhosis, bacterial infection or environment
    toxins
	USA	 	10/936,431	 	US
    7,923,454	 	2004/09/08
                                            ~

    2025/01/27
	 	Organ
    Damage (Liver, Kidney, Lung Damages), Rheumatoid arthritis, Crohn’s Disease, Multiple sclerosis
	USA	 	12/400,344	 	US
    8,017,622	 	2009/03/09
                                            ~

    2023/05/16
	 	Crohn’s
    Disease, Liver Damage
	USA	 	13/228,527	 	US
    9,776,971	 	2011/09/09
                                            ~

    2023/05/16
	 	Organ
    Damage (Liver, Kidney Damages), Crohn’s Disease, Pulmonary fibrosis


 




    	Page 18 of 25



    	 



    

 


DEFINITIVE
AGREEMENT


 


	






	AIH (Autoimmune
    Hepatitis)
	 
	Country	 	Application
    No.	 	Patent
    No. & Current Status	 	Patent
    Term	 	Utility
    Claim
	Taiwan	 	105109186	 	TWI612961	 	2016/03/24
                                 ~

    2036/03/24
	 	Nalmefene, naltrexone or
    derivatives thereof for use in treating AILD
	USA	 	15/078,342	 	US 9,757,372	 	2016/03/23
                                 ~

    2036/03/23
	 	Nalmefene, naltrexone or
    derivatives thereof for use in treating AILD
	Australia	 	20160235093	 	AU2016235093	 	2016/03/24
                                 ~

    2036/03/24
	 	Nalmefene, naltrexone or
    derivatives thereof for use in treating AILD
	Canada	 	2983121	 	CA2983121	 	2016/03/24
                                 ~

    2036/03/24
	 	Nalmefene, naltrexone or
    derivatives thereof for use in treating AILD
	EPO	 	EP16769679.8	 	EP3273958

    (DE,
    FR, GB)
	 	2016/03/24
                                 ~

    2036/03/24
	 	Nalmefene, naltrexone or
    derivatives thereof for use in treating AILD
	Korea	 	1020177030832	 	KR10-2064334

    (Licensed
    out)

    官網資訊權利所有人為타이완제이

    파마슈티컬스
    컴퍼니 리미티드(2022/4/20瀏覽)
	 	2016/03/24
                                            ~

    2036/03/24
	 	Nalmefene, naltrexone or
    derivatives thereof for use in treating AILD
	Russia	 	2017137008	 	RU2707560	 	2016/03/24
                                 ~

    2036/03/24
	 	Nalmefene, naltrexone or
    derivatives thereof for use in treating AILD


 




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	NASH
    (Non-Alcoholic Steatohepatitis), NAFLD (Non-Alcoholic Fatty Liver Disease), ASH (Alcoholic Steatohepatitis)
	 
	Country	 	Application
    No.	 	Patent
    No. & Current Status	 	Patent
    Term	 	Utility
    Claim
	USA	 	15/492,198	 	US
    10,045,977	 	2017/04/20
    ~ 2037/04/20	 	Nalmefene,
    naltrexone or derivatives thereof for use in treating NASH, NAFLD or ASH
	Taiwan	 	106130679	 	Undergoing
    Examination	 	—	 	Nalmefene,
    naltrexone or derivatives thereof for use in treating NASH, NAFLD or ASH
	Australia	 	2017253228	 	2017253228	 	2017/04/20
    ~ 2037/04/20	 	Nalmefene,
    naltrexone or derivatives thereof for use in treating NASH, NAFLD or ASH
	Canada	 	3021788	 	3,021,788	 	2017/04/20
    ~ 2037/04/20	 	Nalmefene,
    naltrexone or derivatives thereof for use in treating NASH, NAFLD or ASH
	China	 	201780024846.0	 	Undergoing
                                            Examination

    (Licensed
    out)

    官網沒有申請權轉移資訊(2022/4/20瀏覽)
	 	—	 	Nalmefene,
    naltrexone or derivatives thereof for use in treating NASH, NAFLD or ASH
	Russia	 	2018136387	 	RU2717677	 	2017/04/20
    ~ 2037/04/20	 	Nalmefene,
    naltrexone or derivatives thereof for use in treating NASH, NAFLD or ASH


 




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DEFINITIVE
AGREEMENT


 


SCHEDULE
3: SUMMARY OF CLINICAL TRIALS OF PRODUCT


 





 




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AGREEMENT


 


SCHEDULE
4: DEVELOPMENT PLAN


 


	 	1.	As
    provided below, Parties shall use reasonable diligence and work in close collaboration such that, in an expeditious manner, clinical
    trials of the Product are completed in support of achieving registration of the Product in the Licensed Territory. Parties agree
    to the following basic approaches to the registration of Product in the Licensed Territory and the conduct of a committee to be formed
    to coordinate the parties’ registration of Product in the Licensed Territory:
	 	 	 
	 	1.1.	Parties
    shall use reasonable diligence in the registration of the Product in the Licensed Territory.
	 	 	 
	 	1.2.	Registration
    Committee (the “Committee”).


 


	 	(a)	A
    committee, co-chaired by representatives of Parties and comprised of representatives from Parties, shall be formed to coordinate
    the registration of the Priority Product in the Licensed Territory and such other matters that the parties mutually agree to assign
    to it. Decisions of the Committee shall be made by a unanimous vote of the Committee, with each party having one (1) vote, regardless
    of the number of representatives attending a meeting. The Committee shall assign study or other registration activities between the
    Parties as set forth by the Committee and as described below:
	 	 	 
	 	(b)	The
    Committee shall review and discuss the registration plans for any countries involved, as well as a coordinated general strategy and
    priorities for preclinical and clinical registration of Product in the Licensed Territory. Each party’s members of the Committee
    will reasonably consider the adoption of the other party’s suggestions and will accept as many of such suggestions as are reasonable,
    based upon medical rationale, drug supply, and the need to conduct the studies in an expeditious and cost-efficient manner.
	 	 	 
	 	(c)	The
    parties will share responsibility and authority to obtain regulatory approvals for the Product in the Licensed Territory. If there
    is a disagreement among the parties concerning an issue related to the registration of the Product in the Licensed Territory, the
    issue shall be resolved in accordance with the provisions below:


 


	 	(i)	If
    the representatives of the parties are unable to reach agreement on a decision related to the Development Plan, the issue shall be
    submitted for consideration, in the case of Licensor, to a designee of its Chief Executive Officer, and, in the case of Licensee,
    to a designee of its Chief Executive Officer. If they are unable to agree, then the Chief Executive Officers of the parties work
    in good faith to reach agreement upon the appropriate decision.
	 	 	 
	 	(ii)	If
    the Chief Executive Officers of the parties are unable to reach agreement on a decision required of them, then the issue shall be
    settled by arbitration in the state of incorporation of the Licensee in accordance with the Commercial Arbitration Rules of the American
    Arbitration Association then in effect. The decision of the arbitrator(s) shall be final and binding on all parties. The cost of
    such arbitration shall be borne by the non-prevailing party, unless otherwise decided by the arbitrator(s).


 


	 	1.3.	Clinical
    Trials and Regulatory Activities


 


	 	(a)	Licensee,
    at its expense (except for the cost of clinical supplies of Product to be provided to Licensee pursuant to the provisions of Schedule
    5), shall, using reasonable efforts, initiate and conduct a study sufficient to support registration of the Product.
	 	 	 
	 	(b)	Licensee
    will complete, at its expense, a trial or multiple trials in the current worldwide program of clinical trials of the Product, including
    one or more of the studies listed in Schedule 3, and will promptly and fully disclose to Licensor the results of the interim and
    final analyses of data from these clinical trials.


 




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	 	(c)	Licensee
    will provide, at its expense, regulatory staff support for preparation of registration documents as such support is reasonably requested
    by Licensor.
	 	 	 
	 	(d)	Licensee,
    notwithstanding the preceding, will be responsible for negotiating labeling, pricing and reimbursement for Priority Product with
    the applicable regulatory authorities in the Licensed Territory, and after registration of the Priority Product will have the primary
    responsibility for the ongoing correspondence and interaction with the applicable regulatory authorities. TPEX will provide reasonable
    assistance to IMUN in such interactions, if necessary.


 


	 	1.4.	Other
    Development Activities.


 


	 	(a)	Except
    as provided above in Section 1, the Committee, in assigning the responsibility for performing specific tasks or activities related
    to a study or registration activity among the parties, shall make such assignments principally based on: (i) the available resources
    each of the parties can commit to the task or activity; (ii) the expertise of each of the parties in conducting or monitoring the
    task or activity; (iii) which party can perform the task or activity in the most expeditious manner; and (iv) which party can perform
    the task or activity in the most cost- efficient manner. A party not responsible for the performance of a task or activity may provide
    advisory and support services to the other party. The committee may establish interdisciplinary project teams comprised of representatives
    of both parties having the specialized skills necessary to oversee the conduct of specific day-to-day registration activities. The
    committee shall establish procedures concerning the scope and conduct of activities (including decision-making procedures) assigned
    to such project teams.
	 	 	 
	 	(b)	Each
    party shall keep the other party informed of its progress in the registration of Product, including making oral presentations of
    progress at the committee meetings and/or the preparing of such written progress reports as are agreed to by the parties summarizing
    such party’s activities during each reporting period and its planned activities for the succeeding period. Each of the parties
    will assign a representative to facilitate communications between the parties; each representative shall report to his/her management
    on the matters discussed at each of the meetings of the parties.
	 	 	 
	 	(c)	Licensor
    will disclose to Licensee all relevant Know-How, including, but not limited to, data and information which it possesses from the
    pre-clinical and clinical studies of Product (including toxicology, pharmacokinetics and formulation studies) in a format which will
    facilitate the preparation for any regulatory filings or other correspondence to be filed or made by Licensee.
	 	 	 
	 	(d)	Licensor
    will transfer to Licensee all regulatory approvals and/or assurances including IND’s and Orphan Drug Designation.
	 	 	 
	 	(e)	Licensor
    will provide assistance to IMUN in accessing clinical investigators, clinical sites and testing laboratories for the purposes of
    data interpretation and/or evaluation and conduct of registration activities assigned to IMUN.


 


	 	2.	Use
    of Licensee Results. If a licensee of Licensor wishes to use the results of studies conducted by Licensee in such licensee’s
    registration and commercialization activities in a country(ies) located outside of the Licensed Territory, the parties shall enter
    into good-faith discussions about the sharing of the costs of such studies and/or the granting to licensee of equivalent rights to
    use the results of any studies conducted by such licensee.
	 	 	 
	 	3.	Supply
    of Product. As described in Schedule 5.
	 	 	 
	 	4.	Substitute
    Drug Product. If development of the Product is discontinued in a country located in the Licensed Territory due to safety, efficacy
    or regulatory issues or by mutual agreement of the parties and Licensee is interested in developing a substitute drug product whose
    manufacture, use or sale would infringe (in the absence of the license rights granted under this Agreement) a valid claim (which
    has not been abandoned, disclaimed or declared invalid in a non-appealable order) included in an issued patent within this Agreement,
    then Parties shall enter into good faith negotiations regarding the terms of a license between parties for such substitute drug product.
    During the period that Licensee is participating in the development and/or commercialization of the Product and/or another drug product
    whose manufacture, use or sale infringes (in the absence of the license rights granted under this Agreement) a valid claim (which
    has not been abandoned, disclaimed or declared invalid in a non-appealable order) included in an issued patent within this Agreement,
    Licensor agrees not to commercialize in the Licensed Territory other drug products whose manufacture, use or sale is covered by a
    valid claim (which has not been abandoned, disclaimed or declared invalid in a non-appealable order) in an issued patent within this
    Agreement, on its own or with a third party, other than Licensee, Licensee’s Affiliates or Licensee’s Sublicensees.


 




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SCHEDULE
5: Product Supply Agreement


 


Parties
agree that Licensor or its supplier(s) shall be the initial manufacturer for Licensee, and that Licensee or its supplier(s) shall have
the Right to Manufacture (as defined below) Product using an alternative manufacturer under conditions set forth in this Product Supply
Agreement.


 


	1.	Registration
    Supply. Licensor will provide sufficient commercial supplies of Product to support and sustain any/all registration activities for
    Product in the Licensed Territory. In the event that Licensor cannot provide sufficient supply of Product to support and sustain
    any/all registration activities for Product in the Licensed Territory, Licensor shall bear all costs and responsibility to procure
    and deliver Product to Licensee. For clarification, any delays in supply of Product prior to registration shall not be construed
    as failures in diligence by Licensee, and Licensor shall reimburse Licensee for any reasonable expenses incurred as a result of delay
    of supplies of Product.
	 	 
	2.	Supply
    after Registration. After registration of Product, Licensor hereby agrees to use its commercially reasonable efforts to maintain
    sufficient manufacturing capacity at its facilities to supply Licensee with commercial quantities of Product to support and sustain
    the commercial launch and subsequent patient demand for Product in the Licensed Territory. After registration of Product, Licensor
    may, at its sole discretion, decide to cease supplying Product to Licensee, and shall notify Licensee immediately and no less than
    six (6) months prior to the last date that Product would be available to Licensee from Licensor as a result of such a decision.


 


	3.	Right
    to Manufacture.


 


	 	3.1.	Licensor
    shall grant Licensee the non-exclusive worldwide right to make and have made Product under applicable Patent Rights and Know-How
    relating to processes, intermediates and materials for manufacturing Product, and will provide to Licensee without charge, to the
    extent available, technical and manufacturing assistance and use of its technology and proprietary information for the Product, including
    information on its analytical methods, validation reports and manufacturing processes.
	 	 	 
	 	3.2.	Licensee
    may, at its sole discretion, exercise its Right to Manufacture if one or more conditions in this Section occur. In the event of such
    an exercise of rights, Licensor agrees to assist Licensee in the identification of alternative low-cost manufacturing sources for
    the Product, including but not limited to, access to current suppliers of starting materials, intermediates, bulk material and/or
    finished Product.


 


	 	(a)	Availability
    from Licensor. In the event that Licensor notifies Licensee that Product will not be manufactured for Licensee, Licensee may exercise
    its Right to Manufacture with that alternative source.
	 	 	 
	 	(b)	Cost
    Improvement. Licensee shall have the right, but not obligation to compare the cost of Product as provided by Licensor (inclusive
    of all costs incurred by Licensee to make or have made to the extent necessary for Licensee to receive sales revenues) to an alternative
    manufacturing source of its choosing. In the event that Licensee establishes that an alternative source would provide a lower cost
    to Licensee than that which is offered by Licensor, Licensee may exercise its Right to Manufacture with that alternative source.
	 	 	 
	 	(c)	Timeliness.
    Licensee shall have the right, but not obligation to compare the time for delivery of Product provided by Licensor to an alternative
    manufacturing source. In the event that Licensee establishes that an alternative source would provide a shorter period of time from
    order to receipt of Product in useable form to Licensee or its designee than that which is offered by Licensor, Licensee may exercise
    its Right to Manufacture with that alternative source.


 




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	 	(d)	Legal
    or Regulatory Limitations. If Licensee becomes aware that there are current or impending limitations due to regulatory restrictions
    or law in a Licensed Territory as a result of manufacture by Licensor, Licensee may exercise its Right to Manufacture with an alternative
    source that remedies such limitations.
	 	 	 
	 	(e)	Quality.
    If Licensee becomes aware that Product supplied by Licensor has or may threaten current or future compliance with quality standards
    required for continued commercialization or other quality agreements, Licensee may exercise its Right to Manufacture with an alternative
    source that remedies such issues with quality.
	 	 	 
	 	(f)	Other
    Reasons. Parties shall inform the other when there are opportunities to improve the commercial success of Product in the Licensed
    Territory by utilizing a manufacturer other than the Licensor. In the event that Licensor cannot, or choses not, to make adjustments
    that would reasonably offset such opportunities, Licensee may exercise its Right to Manufacture.


 


	 	3.3.	Reporting
    and Forecasting.


 


	 	(a)	At
    the request of Licensee, Licensor shall provide a report of the cost of manufacture of Product to Licensee. The report shall be sufficiently
    detailed that Licensee can determine the cost per unit that it pays to the Licensor for Product.
	 	 	 
	 	(b)	After
    registration of Product, Licensor shall provide Licensee a twelve (12) month forecast of the cost that Licensee will incur for supply
    of Product by Licensor on each annual anniversary of the date of registration.


 




    	Page 25 of 25