LICENSE
AGREEMENT 


 


THIS
LICENSE AGREEMENT (this “Agreement”) including all exhibits hereto is made, entered and is effective as of
February 7, 2017 (the “Effective Date”), by and between Regen BioPharma, Inc., a Nevada corporation
with principal address 4700 Spring Street, Suite 304, La Mesa, California 91942 (“Licensor”) and Checkpoint
Immunology, Inc., a Nevada corporation with principal address at 4700 Spring Street, Suite 304, La Mesa, California 91942 (“Licensee”).
As used herein, the term “Parties” is sometimes used to refer to the Licensor and the Licensee jointly.


 


WHEREAS:


 


		A.	The
                                         Licensor owns or has the right to grant certain rights and know-how rights with respect
                                         to certain intellectual property as defined and set forth in Exhibit A (the “Licensed
                                         Property” “Licensed Patent Rights” and Licensed Know How”).



 


		B.	Licensee
                                         desires to obtain from Licensor an exclusive worldwide right and license for the development
                                         and commercialization of the Licensed Property for certain licensed uses as set forth
                                         in Exhibit B (the “Licensed Applications”).



 


		C.	Licensor
                                         is willing, subject to the terms and conditions of this Agreement, to grant Licensee
                                         certain rights to the Licensed Property in accordance with the Licensed Applications.



 


NOW,
THEREFORE in consideration of the foregoing and the mutual agreements set forth below, the Parties agree as follows:


 


ARTICLE
1 


DEFINITIONS



 


The
terms in this Agreement with initial letters capitalized, whether used in the singular or the plural, shall have the meaning set
forth below or, if not listed below, the meaning designated in places throughout this Agreement.


 


 1.1 “Act” means the United States Food, Drug and Cosmetic Act, as amended.




 


1.2
“Affiliate” of a Person means any other Person which (directly or indirectly) is controlled by, controls
or is under common control with such Person. For the purposes of this definition, the term “control” (including, with
correlative meanings, the terms “controlled by” and “under common control with”) as used with respect
to a Person, shall mean the possession, directly or indirectly, of the power to direct, or cause the direction of, the management
or policies of such Person, whether through the ownership of voting securities, by contract or otherwise, and “control”
shall be presumed to exist if either of the following conditions is met: (i) in the case of a corporate entity, direct or
indirect ownership of voting securities entitled to cast at least fifty percent (50%) of the votes in the election of directors
or (ii) in the case of a non-corporate entity, direct or indirect ownership of at least fifty percent (50%) of the equity
interests with the power to direct the management and policies of such entity.


 



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1.3
“Approval” means, with respect to any Licensed Product in any regulatory jurisdiction, approval from the
applicable Regulatory Authority sufficient for the manufacture, distribution, use, marketing, and sale of the Licensed Product
in such jurisdiction in accordance with applicable Laws; provided, however that for purposes of the U.S., Approval means BLA Approval
and for purposes of the EU, Approval means MAA Approval.


1.9
“Business Day” or “business day” means a day other than Saturday, Sunday or any day
on which commercial banks located in New York, New York are authorized or obligated by Law to close.


1.10
“Calendar Quarter” means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30
and December 31.


 


1.11
“Calendar Year” means each one-year period commencing on January 1 and ending on December 31.


1.12
“Clinical Trial” means any human clinical study of a pharmaceutical product.


1.13
“Combination Product” means a Licensed Product that includes at least one additional active ingredient
other than the Licensed Compound. Drug delivery vehicles, adjuvants, and excipients shall not be deemed to be “active ingredients”,
except in the case where such delivery vehicle, adjuvant, or excipient is recognized by the FDA as an active ingredient in accordance
with 21 CFR 210.3(b)(7).


1.14
“Commercialization” or “Commercialize” means activities directed to commercially manufacturing,
obtaining pricing and reimbursement approvals including regulatory activities relating to same, marketing, promoting, distributing,
importing or selling a Licensed Product.


1.15
“Commercially Reasonable Efforts” means,


(a)
with respect to the efforts to be expended by Licensor with respect to any objective, activity or decision to be undertaken
under this Agreement, those efforts that a company within the bio-pharmaceutical industry of comparable size and resources [ *
] would reasonably use to accomplish such objective, activity or decision, and specifically means the carrying out of Development
and Commercialization activities using efforts that a company within the bio-pharmaceutical industry of comparable size and resources
[ * ] would reasonably devote to a product at a similar stage in its development or product life and of similar market potential,
profit potential, based on conditions then prevailing and taking into account efficacy, safety, intellectual property protection,
approved labeling, the competitiveness of alternative products sold by Third Parties in the marketplace, the patent and other
proprietary position of the product, and the likelihood of regulatory approval given the regulatory structure involved. Commercially
Reasonable Efforts shall be determined on a Major Markets Countries-by-Major Markets Countries basis for the Licensed Product,
and it is anticipated that the level of effort will change over time, reflecting changes in the status of the Licensed Product
and the Major Market(s) Country(ies) involved. Without limiting the foregoing, Commercially Reasonable Efforts require that Licensee:
(i) promptly assign responsibility for such Development and Commercialization activities to specific individuals who are
held accountable for progress and monitor such progress on an on-going basis, (ii) set and consistently seek to achieve specific
and meaningful objectives and timelines for carrying out such Development and Commercialization activities, and (iii) consistently
make and implement decisions and allocate resources designed to advance progress with respect to such objectives and timelines.






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(b)
with respect to the efforts to be expended by Licensee with respect to any objective, activity or decision to be undertaken
under this Agreement, those efforts consistent with the commercially reasonable practices normally devoted by Licensee.


1.16
“Competitive Compound” means any small molecules that are designed to modulate the activity of the NR2F6
protein in vitro, in experimental animals or in humans.


 


1.17
“Confidential Information” means all trade secrets, processes, formulae, data, Know-How, improvements,
inventions, chemical or biological materials, techniques, marketing plans, strategies, customer lists, or other information (including
all information and materials of a Party’s customers and any other Third Party and their consultants) that has been disclosed
by a Party to the other Party under this Agreement, regardless of whether any of the foregoing are marked “confidential”
or “proprietary” or communicated to the other by the disclosing Party in oral, written, graphic, or electronic form.


1.18
“Controlled” or “Controls”, when used in reference to intellectual property right or
other intangible rights, shall mean the legal authority or right of a Party (or any of its Affiliates) to grant a license or sublicense
of intellectual property rights to the other Party or any Third Party, or to otherwise disclose confidential, proprietary or trade
secret information to such other Party or to any Third Party, without breaching the terms of any agreement with any Third Party.


1.19
“Development” means non-clinical and clinical drug development activities reasonably related to the development
and submission of information to a Regulatory Authority, including toxicology, pharmacology and other discovery and pre-clinical
efforts, test method development and stability testing, process development, formulation development, development manufacturing,
delivery system development, quality assurance and quality control development, statistical analysis, clinical studies (including
pre- and post-Approval studies but specifically excluding regulatory activities directed to obtaining pricing and reimbursement
approvals), and post-marketing commitments/requirements. When used as a verb, “Develop” means to engage in
Development.


1.20
“Development Plan” means, with respect to a Licensed Product, a plan and related timing estimates prepared
by Licensee for the then current calendar year and the two (2) following years setting forth a summary of the Development
activities to be conducted for such Licensed Product in all Major Market Countries, including the indications expected to be targeted,
a good faith estimate of reasonable timelines for completing key Development activities and filing of key regulatory submissions
(including estimated timelines for commencement of each stage of clinical Development), and including, where known, the primary
endpoints and any comparator or agents to be used in combination with a Licensed Compound/Licensed Product for any such studies
and any go/no-go decision criteria for any such studies. The initial Development Plan as of the Effective Date is attached hereto
as Exhibit A1. A copy of the study protocol for a given study will be provided to Licensee if available and if requested by Licensee.


 



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1.21
“Distributor” means, with respect to a country, any Third Party that is used by pharmaceutical manufacturers
generally in such country on a non-exclusive basis (and without any grant or license by Licensor of any intellectual property
rights) to sell and distribute finished, packaged pharmaceutical products to pharmacies, managed care organizations, governmental
agencies (e.g., federal, state and local), and other group purchasing organizations (e.g., pharmaceutical benefits
managers) and the like in such country; provided, that Licensor shall be permitted to grant or license such intellectual property
rights to the Third Party solely to the extent reasonably necessary to comply with applicable law or to enable such distributor
to sell and distribute (but not to market or promote) a Licensed Product. For clarity, a Distributor of a Licensed Product in
a country shall not include any person or entity that has been granted a right, whether by license or otherwise and whether express
or implied (including by subcontract or agency), by a Party or its Affiliates to research, Develop or manufacture (but a Distributor
may have the right to repackage or relabel finished product specifically for sale or distribution in such country) any such Licensed
Product or that otherwise assumes any regulatory or other responsibilities with respect to obtaining or maintaining regulatory
approvals for such Licensed Product in such country.


1.22
“Dollar” or “$” means the lawful currency of the United States.


1.23
“EMA” means the European Medicines Agency, or any successor agency thereto.


1.24
“EU” means the European Union, as its membership may be altered from time to time, and any successor thereto.


1.25
“FDA” means the U.S. Food and Drug Administration, or any successor agency thereto.


1.26
“Field” means all therapeutic and diagnostic uses in humans and animals, including the prevention, treatment
or control of any disease, disorder or condition.


1.27
“First Commercial Sale” means, with respect to any Licensed Product in a country in the Territory, the
first sale for use or consumption by the general public of such Licensed Product in such country after Approval of such Licensed
Product has been granted, or such marketing and sale is otherwise permitted, by the Regulatory Authority of such country.


1.28
“GAAP” means United States generally accepted accounting principles, consistently applied.


1.29
“Governmental Authority” means any multi-national, national, federal, state, local, municipal, provincial,
county, or other political subdivision, agency or other body, domestic or foreign or other government authority of any nature
(including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, court, tribunal
or other entity).


 



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1.30
“IND” means an Investigational New Drug Application, as defined in the Act, filed with the FDA or its foreign
counterparts, including as applicable clinical trial applications (“CTAs”), clinical trial exemptions (“CTXs”)
and investigational medicinal product dossiers.


1.31
“Initiation” means, when used with respect to a Clinical Trial, the dosing of the first patient with the
first dose in such Clinical Trial.


1.32
“Know-How” means tangible and intangible information, techniques, technology, practices, inventions (whether
patentable or not), methods, knowledge, trade secrets, data and results (including all biological, chemical, pharmacological,
toxicological, clinical, analytical and quality control data and methods (including any applicable reference standards), manufacturing
assay and related data, manufacturing and formulation processes, data and results relating to drug substance, drug product, starting
materials, and radiolabeled compounds, know-how and trade secrets).


1.33
“Knowledge” means, with respect to Licensee, the actual knowledge of the employees and consultants involved
with development of the intellecutual property being licensed from the LICENSOR .


1.34
“Laws” means all applicable laws, statutes, rules, regulations and other pronouncements having the effect
of law of any Governmental Authority that may be in effect from time to time, including for clarity any applicable rules, regulations
and other requirements of any Regulatory Authority that may be in effect from time to time.


1.35
“Licensed Compound” means all chemical matter disclosed in the patents and patent applications associated
with this agreement. Also, any future chemical matter discovered by licensee will be deemed a derivative of licensed compound
and will be bound by this agreement. Furthermore, any patents or patent applications may be included by licensor as an amendment
to this agreement.


1.36
“Licensed Product” means any pharmaceutical product containing a Licensed Compound (alone or with other
active ingredients Controlled by Licensor), in all forms, presentations, formulations and dosage forms. For clarity, “other
active ingredients” does not include any other active ingredients or molecules that are proprietary to, or Controlled by,
Licensor and its Affiliates and would require a license from Licensor with respect to the composition, method of use or manufacture
of such other molecule, unless separately licensed from Licensor or its Affiliates.


1.37
“MAA” means a marketing authorization application filed for Approval in the EU of the applicable Licensed
Product.


1.38
“MAA Approval” means Approval by the EMA of a MAA filed with the EMA for the applicable Licensed Product
under the centralized European procedure. If the centralized EMA filing procedure is not used, MAA Approval shall be achieved
upon the first Approval for the applicable Licensed Product in three of the following countries: France, Germany, Italy, Spain
and the United Kingdom. For clarity, MAA Approval shall include any pricing and reimbursement approvals required prior to sale
of such Licensed Product in the European Union, or in connection with Approvals achieved in three of the foregoing five European
Union member states; provided, that MAA Approval shall in any event be deemed achieved upon First Commercial Sale in any country
in the European Union.


 



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1.39
“MAA Filing” means the validation by the EMA of a centralized filing of an MAA for the applicable Licensed
Product.


1.40
“Major Market Countries” means the following countries: All PCT countries, Canada, Australia, China, Japan
and South American countries.


 


1.41
“Net Sales” means, with respect to any Licensed Product, the gross amount invoiced in arm’s-length
transactions by a Party, an Affiliate of such Party, or any permitted SubLicensee (or such SubLicensee’s Affiliates) shall
be considered a “Related Party” for sales of such Licensed Product to a Third Party, less the sum of the following
(to the extent not reimbursed by any Third Party):


(a)
discounts (including cash discounts and quantity discounts), cash and non-cash coupons, retroactive price reductions, charge-back
payments and rebates granted to managed care organizations or to federal, state and local governments, their agencies, and purchasers
and reimbursers or to customers;


(b)
credits or allowances actually granted upon claims, damaged goods, rejections or returns (including inventory management fees)
of such Licensed Product, including Licensed Product returned in connection with recalls or withdrawals;


(c)
amounts written off by reason of uncollectible debts;


(d)
freight, postage, shipping, transportation and insurance charges for the delivery of the Licensed Product; and


(e)
taxes or duties levied on, absorbed or otherwise imposed on sale of the Licensed Product, including value-added taxes, healthcare
taxes or other governmental charges otherwise imposed upon the billed amount (to the extent not paid by the Third Party), as adjusted
for rebates and refunds, in each case as accounted for by the party recording such Net Sales.


No
deduction shall be made for any item of cost incurred by any Related Party in Developing or Commercializing Licensed Products
except as permitted pursuant to clauses (a) to (d) of the foregoing sentence; provided that, Licensed Products transferred
to Third Parties in connection with clinical and non-clinical research and trials, Licensed Product samples, compassionate sales
or use, or an indigent program or for similar bona fide business purposes in accordance with applicable local laws and regulations
in which a Related Party agrees to forego a normal profit margin for good faith business shall give rise to Net Sales only to
the extent that any Related Party invoices or receives amounts therefor exceeding the cost of goods.


Such
amounts shall be determined consistent with a Related Party’s customary practices and in accordance with GAAP.


It
is understood that any accruals for individual items reflected in Net Sales are annually trued up and adjusted by each Related
Party consistent with its customary practices and in accordance with GAAP.






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Sale
or transfer of Licensed Products between any of the Related Parties shall not result in any Net Sales, with Net Sales to be based
only on any subsequent sales or dispositions to a non-Related Party. To the extent that any Related Party receives consideration
other than or in addition to cash upon the sale or disposition of a Licensed Product to a non-Related Party, Net Sales shall be
calculated based on the weighted-average price charged for such Licensed Product, as applicable, during the preceding royalty
period, or in the absence of such sales, based on the fair market value of the Licensed Products, as determined by the Parties
in good faith. For clarity, (i) Net Sales shall not include amounts any licensed product distributed for promotional purposes,
subject to verification by licensor; (ii) Net Sales by a Related Party to a non-Related Party consignee are not recognized
as Net Sales by such Related Party until the non-Related Party consignee sells the Licensed Product.


In
the case of any Combination Product sold in the Territory, Net Sales for such Combination Product shall be calculated by multiplying
actual Net Sales of such Combination Product by the fraction A/(A+B) where A is the invoice price of the Licensed Product that
contains only Licensed Compound as its active ingredient if sold separately, and B is the total invoice price of the other active
ingredient or ingredients in the Combination Product, if sold separately. If, on a country-by-country basis, the other active
ingredient or ingredients in the Combination Product are not sold separately in said country, Net Sales for the purpose of determining
royalties of the Combination Product shall be calculated by multiplying actual Net Sales of the Combination Product by the fraction
C/D, where C is the invoice price of the Licensed Product that contains only Licensed Compound as its active ingredient if sold
separately, and D is the invoice price of the Combination Product. If neither the Licensed Product that contains only Licensed
Compound as its active ingredient nor the other active ingredient(s) are sold separately in a given country, the Parties shall
determine Net Sales in accordance with the formulas provided above in this paragraph, or, if neither the Licensed Product that
contains only Licensed Compound as its active ingredient nor the other active ingredient(s) are sold in any other countries, the
Parties shall negotiate in good faith a reasonable adjustment to Net Sales in such country. Notwithstanding the foregoing, for
purposes of determining royalties and milestones on Net Sales under this Agreement, the portion of Net Sales of the Combination
Product allocated to the Licensed Product shall calculated based upon the above formula.


1.42
“Patent Rights” means (a) patents and patent applications, (b) all divisionals, continuations,
continuations-in-part thereof or any other patent application claiming priority directly or indirectly to (i) any of the
patents or patent applications in subsection (a), or (ii) any patent or patent application from which the patents or patent
applications in (a) claim direct or indirect priority, (c) all patents issuing on any of the foregoing in (a)-(b), (d) all
foreign counterparts of any of the foregoing in (a)-(c), including PCT Applications, and (e) all registrations, reissues,
re-examinations, supplemental protection certificates, or extensions of any of the foregoing in (a)-(d).






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1.43
“Person” means any individual, firm, corporation, partnership, limited liability Licensor, trust, business
trust, joint venture, governmental authority, association or other entity.


 


1.44
“Phase II Clinical Trial” means a Clinical Trial of a Licensed Product on a sufficient number of subjects
that is designed to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical
safety and activity in a target patient population, as described in 21 C.F.R. 312.21(b), or a similar clinical study prescribed
by a Regulatory Authority outside the U.S.


1.45
“Phase IIa Clinical Trial” means a Phase II clinical trial of a compound or product, the principal purpose
of which is a preliminary determination of safety and pharmacodynamic effect or efficacy in the target population over a range
of doses.


1.46
“Phase IIb Clinical Trial” means a Phase II clinical trial of a compound or product, the principal purpose
of which is a further determination of efficacy and safety, in the target population, at the intended clinical dose or doses or
range of doses, on a sufficient number of subjects and for a sufficient period of time to confirm the optimal manner of use of
such compound or product (dose and dose regimen) prior to initiation of the Phase III Clinical Trials.


1.47
“Phase III Clinical Trial” means a Clinical Trial of a Licensed Product on a sufficient number of subjects
that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings,
precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range and dose duration
to be prescribed, which trial is intended to support Approval of a Licensed Product, as described in 21 C.F.R. 312.21(c), or a
similar clinical study prescribed by a Regulatory Authority outside the U.S.


1.48
“PMDA” means the Japanese Pharmaceutical and Medical Device Agency or its successor, or Ministry of Health,
Labour and Welfare.


1.49
“PMDA Filing” means the acceptance by the PMDA of the filing of an MAA for the applicable Licensed Product
in Japan.


1.50
“Regulatory Authority” means any national or supranational governmental authority, including the FDA, PMDA
or EMA, that has responsibility in countries in the Territory over the Development and/or Commercialization of the Licensed Compounds
and/or Licensed Products.






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1.51
“Sublicense Revenues” means all consideration Licensee receives from a SubLicensee pursuant to any Sublicense
or from a Third Party assignee pursuant to an assignment of this Agreement that is not a permitted assignment pursuant to Section 15.4.2,
including any upfront payment, milestone payments and royalty payments (excluding that portion of any milestone or royalty payment
amounts received from a SubLicensee or assignee that are paid by Licensee as milestone and royalty payments to LICENSor under
Article 8 hereof); collaboration fee; and premiums on equity investments in Licensee in connection with the grant of the Sublicense
(with the premium to be reasonably allocated to the value of this Agreement)[ * ]; and in any event excluding, for clarity, any
amounts received by Licensee: (a) as bona fide, fair market value, actual reimbursement for research, Development or Commercialization
activities performed or paid for by Licensee after the grant of a Sublicense, and only to the extent they are documented and are
reasonably detailed [ * ]; (b) for reimbursement of Licensee’s fully-burdened cost to manufacture and supply Licensed
Products or Licensed Compounds; or (c) in the form of bona fide loans made by SubLicensee or assignee to Licensee. For clarity,
Sublicense Revenues from milestones and royalties include the amounts received by Licensee in excess of the amounts paid to LICENSor
under Article 8 for substantially the same milestone or royalties. For further clarity, a Change of Control of Licensee shall
not be deemed a Sublicense. “Change of Control” shall mean any transaction or series of transactions, whether by merger,
sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of
Licensee in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction
no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.


1.52
“Sublicense” means a grant of rights by Licensee to a SubLicensee under any of the rights licensed to Licensee
by LICENSor under Section 2.1 with respect to the Development, manufacture, or Commercialization of any Licensed Product
or Licensed Compound, and includes any reverse co-promotion agreements.


1.53
“Sublicense Agreement” means a written, definitive agreement for a Sublicense.


1.54
“SubLicensee” means any Third Party to whom rights are granted under any of the rights licensed to Licensee
by LICENSor under Section 2.1 with respect to any Licensed Product or Licensed Compound, including through any license, sublicense,
co-development, co-discovery, co-promotion, distribution, joint venture, Development and Commercialization collaboration or similar
transaction between Licensee (or an Affiliate of Licensee) and a Third Party. For clarity, a Distributor or a Licensee contractor
permitted pursuant to Section 3.7 is not considered a SubLicensee.


1.55
“Territory” means worldwide.


1.56
“Third Party” means any Person other than Licensor and LICENSEE, and any Affiliates of Licensor and LICENSEE.


1.57
“United States” or “U.S.” means the United States of America including Puerto Rico and
any U.S. territories and possessions.


1.58
“Valid Claim” means a claim of (i) an issued and unexpired patent, which claim has not been held invalid
or unenforceable by a court or other government agency of competent jurisdiction from which no appeal can be or has been taken
and has not been held or admitted to be invalid or unenforceable through re-examination or disclaimer, opposition procedure, nullity
suit or otherwise, or (ii) a pending patent application that has not been finally abandoned, finally rejected or expired.


 






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Additional
Definitions. In addition to those terms defined above, definitions for each of the following terms are found in the body
of this Agreement as indicated below:


 


1.59
“Field” shall mean all therapeutic uses related to treatment of diseases in humans.





1.60
“Improvements” shall mean any development, discovery or invention that is conceived, reduced to practice or otherwise
developed by or on behalf of a Party, whether or not patentable, that is a modification, improvement or enhancement to, and is
dominated by the claims of, the Patent Rights.





1.61
“Licensed Product” shall mean any product sold by or on behalf of Licensee, its Affiliates or its subLicensees
under the applicable sublicense agreement, the manufacture, use or sale of which would infringe a valid claim within the Patent
Rights in the country of such manufacture, use or sale but for the license granted herein.


1.62
“Licensor Know-How” shall mean any and all technical and scientific information, owned or controlled by Licensor
as of the Effective Date and at any time during the Term to the extent that such information relates to the Licensed Technology
as applicable to the Field, including, for example, ideas, discoveries, knowledge, know-how, data processes, procedures, methods,
techniques, protocols, formulae, trade secrets, inventions (whether or not patentable), research tools, formulations, other physical,
chemical or biological information, including without limitation improvements to such information.





1.63
“Patent Rights” shall mean any and all rights which are granted under any patents listed in Exhibit A, Patents
which may issue on the applications listed in Exhibit A and all Patents hereafter filed, owned or controlled by Licensor that
claim an Improvement dominated by the claims of one or more of the patent rights described above, each to the extent that they
are applicable to the Field.





1.64
“Commercialization” or “Commercialize” means activities directed to marketing, promoting, research
and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including
sub-licensing or sub-contracting of these activities.





1.65
“Develop” or “Developments” shall mean pre-clinical and clinical research and development activities,
including toxicology and other pre-clinical development efforts, stability testing, process development, pre-formulation, formulation
development, delivery system development, quality assurance and quality control development, statistical analysis, clinical pharmacology,
clinical studies (including without limitation Clinical Trials), regulatory affairs, and regulatory approval and clinical study
regulatory activities.






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1.66
“Term” shall mean 15 years.


 





1.67
“Quarter” means each of the four (4) thirteen (13) week periods; (i) commencing on January 1 of any calendar year.


 





1.68
“Net Sales” shall mean the gross amount billed or invoiced by Licensee, its Affiliate, or its subLicensees (“Seller”)
in U.S. dollars for the final end-user sale or other disposition of Licensed Products, less the following deductions (to the extent
such deductions are not already deducted from the amount billed or invoiced and to the extent such deductions are not otherwise
recovered or reimbursed):





(a)
actual amounts, net of recoveries, of any discounts, charge backs, rebates, allowances for bad debts or uncollectible amounts
(provided that such amounts have been formally designated as such in accordance with Seller’s internal accounting procedures,
consistently applied) and allowances actually taken;





(b)
sales, use, value added and excise taxes, import and customs duties, tariffs, and any other similar government charges, taxes,
duties or tariffs, directly imposed against gross sales and to the extent actually paid by or charged to the account of the Seller;


(c)
freight, insurance, packaging and insurance costs and other transportation charges to the extent included in the sales price;


(d)
amounts corresponding to usual and customary retroactive price reductions actually taken, and


(e)
amounts corresponding to credits, allowances or deductions for returns, or rejected or damaged goods, defects, recalls, commissions,
stocking allowances, or marketing and promotional expenses.


 


Notwithstanding
the foregoing, “Net Sales” shall not include amounts (i) for any Licensed Product furnished to a third party for which
payment (other than the cost of the Licensed Product) is not intended to be received, including, but not limited to, Licensed
Products used in Clinical Trials and Licensed Products distributed as promotional and free goods or (ii) from sales or other dispositions
of Licensed Products between Licensee and any of its Affiliates or between Licensee or any of its Affiliates and a subLicensee,
unless such Affiliate or subLicensee, as the case may be, is an end-user of such Licensed Product.









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1.69
“First Commercial Sale” shall mean, with respect to each Licensed Product, the first sale of such Licensed Product
by Licensee or its Affiliates or subLicensees to a third party for which payment has been received in any country in the Territory
after all applicable required regulatory approvals have been granted by the applicable regulatory authority in such country.


 





1.70
“Territory” shall mean worldwide rights


 





1.71
“Licensed Technology" means (a) a pending or issued claim of the Patent Rights; and/or (b) the Know-How


 


ARTICLE
2


LICENSE
GRANT


 


2.1
LICENSEE Patent Rights and LICENSEE Know-How.


 


2.1.1
Subject to all the terms and conditions set forth in this Agreement, Licensor hereby grants to Licensee a non-transferable
(except in accordance with Section 15.4), exclusive license, with the right to sublicense in accordance with Section 2.2,
under the Licensed Property and Licensed Patent Rights and Licensed Know-How set forth in Exhibit A attached hereto solely
to the extent necessary to research, discover, Develop, make, have made, use, sell, offer to sell, export and import Licensed
Compounds and/or Licensed Products in the Field in the Territory. For clarification, nothing in this Section 2.1 or this
Agreement shall be interpreted as a grant of rights to make, have made, sell, use, co-formulate or use in combination a Licensed
Compound with any molecule that is not a Licensed Compound and is proprietary to Licensor or its Affiliate or would require a
license from Licensor with respect to the composition, method of use or manufacture of such other molecule (unless separately
licensed from Licensor or its Affiliates with Licensor and its Affiliates being under no obligation, express or implied, to do
so).





 


2.1.2
Subject to all the terms and conditions set forth in this Agreement, Licensor hereby grants to Licensee a non-transferable
(except in accordance with Section 15.4), exclusive license for development of human based products, without the right
to sublicense except to Licensee Affiliates and non-profit institutions solely for the purpose identified in Section 5.7),
under patent rights and know-how Controlled by Licensor or its Affiliates covering the manufacture, composition of matter or method
of use of the reagents and research tools set forth on Appendix 10 hereto, solely to the extent necessary to research, discover,
Develop, make, have made, use, sell, offer to sell, export and import Licensed Compounds and/or Licensed Products in the Field
in the Territory.


 


2.2
Sublicenses. Licensee shall have the right to grant Sublicenses with respect to the rights licensed to Licensee under
Section 2.1: provided that, in each case (x) and (y), such Sublicenses are granted solely in accordance with
this Section 2.2:


 






    	 	12	 



     


    

 


2.2.1
Licensee shall have the right to enter into a Sublicense Agreement, provided that:


 


(a)
such Sublicense Agreement shall refer to this Agreement and shall be subordinate to and consistent with the terms and conditions
of this Agreement, and, shall not limit Licensee’s ability to fully perform all of its obligations under this Agreement
(except to the extent assumed by SubLicensee but as to which Licensee remains responsible to Licensor for the performance thereof
by the SubLicensee) or Licensor’s rights under this Agreement;


 


(b)
in such Sublicense Agreement, the SubLicensee shall agree in writing to fully perform the terms and conditions of this Agreement
applicable to the Licensee;


 


(c)
promptly after the execution of such Sublicense Agreement, Licensee shall provide a copy of such Sublicense Agreement to Licensor,
which copy may be redacted to remove confidential terms that are not necessary for Licensor to confirm the Sublicense Agreement’s
compliance with, or calculations of Sublicense Revenues under the terms and conditions of this Agreement;


 


(d)
Licensee shall remain primarily responsible and liable for performance of all of its obligations under this Agreement (even
where sublicensed or assumed by a SubLicensee) and for compliance by its SubLicensees with applicable terms of this Agreement,
including all payments due (including, without limitation, its payment obligations under Sections 11.1 and Articles 8 and 10 hereof)
and the making of reports under this Agreement on account of its SubLicensees’ activities under the Sublicense Agreement,
and shall use Commercially Reasonable Efforts to monitor such SubLicensee’s compliance with and to enforce the terms of
such Sublicense Agreement;


 


(e)
the SubLicensee shall assume and agree in writing to be bound by and comply with the applicable terms and conditions of this
Agreement in the same manner as Licensee, including, without limiting the generality of the foregoing, the SubLicensee shall [
* ];


 


(f)
such SubLicensees shall, except with prior written consent of Licensee and Licensor in each of their sole discretion and in
any event in accordance with and subject to all of the terms and conditions of this Section 2.2 and all of the other terms
and conditions of this Agreement;


 


(g)
any Sublicense rights granted by Licensee in a Sublicense Agreement (to the extent such Sublicense rights are granted to Licensee
in this Agreement) shall terminate effective upon the termination under Article 13 of the license from Licensor to Licensee with
respect to such sublicensed rights, provided that such Sublicense rights shall not terminate if, as of the effective date of such
termination under Article 13, the SubLicensee is not in material breach of its obligations to Licensee under its Sublicense Agreement,
the SubLicensee was previously granted an exclusive Sublicense to Develop and Commercialize the Licensed Products or Licensed
Compounds, and, within sixty (60) days of such termination, the SubLicensee agrees in writing to be bound directly to Licensor
under a license agreement substantially similar to this Agreement with respect to the rights and obligations Sublicensed by Licensee
to the SubLicensee under the Sublicense Agreement, substituting such SubLicensee (a “Surviving SubLicensee”)
for Licensee. New agreement between former Sublicense (now licensee) and Licensor shall be negotiated on good faith independent
from this agreement.





 






    	 	13	 



     


    

 


(h)
the provisions of this Section 2.2 shall also apply in the event of any subsequent amendment or modification of any such
Sublicense Agreement; and


 


(i)
Licensor shall be made an express third party beneficiary of the SubLicensee’s obligations under such Sublicense that
relate to compliance with the applicable terms and conditions of this Agreement with the express right to enforce same directly
against the SubLicensee or against Licensee as Licensor may elect .


 


2.2.2
For clarity, where provisions of this Agreement provide that Licensor shall be “solely” responsible or the like
with respect to a matter (for example, Sections 5.4, 5.5, or 7.1), it is understood that such responsibilities may be carried
out or borne on Licensee’s behalf by an Affiliate of Licensor or by a permitted SubLicensee or contractor of Licensee.


 


2.2.3
It shall be a material breach of this Agreement for Licensee to enter into any Sublicense hereunder not in compliance with
this Section 2.2 without the prior written consent of Licensor.


 


2.3
No Trademark License. No right or license, express or implied, is granted to Licensee to use any trademark, trade name,
trade dress, domain name, logos, slogans, or service mark owned or Controlled by Licensor or any of its Affiliates. Licensee,
at its sole cost and expense, shall be responsible for the selection, registration and maintenance of all trademarks which it
employs in connection with Licensed Products and its activities conducted pursuant to this Agreement, if any, and shall own and
Control such trademarks.


 


2.4
No Implied Licenses. No license or other right is or shall be created or granted hereunder by implication, estoppel
or otherwise. All such licenses and rights are or shall be granted only as expressly provided in this Agreement.


 


2.5
Retained Rights. All rights not expressly granted by a Party hereunder are reserved by such Party and may be used by
such Party for any purpose. Nothing in this Agreement shall prevent (i) Licensor and its Affiliates from using for any purpose
any Licensed Know-How that is in the public domain as of the Effective Date (or enters the public domain thereafter) and is not
covered by a Valid Claim of a Licensed patent right or (ii) Licensor and its Affiliates from using for any purpose any Licensed
Know-How that is in the public domain as of the Effective Date (or enters the public domain thereafter) and, subject to terms
of this Agreement, is not covered by a Valid Claim of a Licensed Patent Right.


 






    	 	14	 



     


    

 


ARTICLE
3


TRANSFER
OF KNOW-HOW, IND AND PGX DATABASE; TECHNICAL ASSISTANCE


 


3.1
Documentation.


 


3.1.1
Licensor shall provide Licensee with electronic (or tangible embodiments, if electronic is not available) of the Know-How
listed in Exhibit A within the period of time following the Effective Date and in the format set forth on Exhibit A including
copies of originals of laboratory notebooks or pages thereof and, where required by Licensor to fulfill its duties under applicable
Law, copies of manufacturing run and batch records required to be maintained by Licensor under applicable Law; provided that,
with respect to Licensed Know-How contained in laboratory notebooks, Licensor shall only be required to provide Licensee with
copies of those laboratory notebook pages (electronic copies, if they exist) that contain Licensed Know-How relating Licensed
Products. Such documentation is Confidential Information of Licensor licensed in accordance with this Agreement and shall not
be used by Licensee for any purpose other than for the discovery, research, manufacture, Development or Commercialization (including
any import, manufacture, use, offer for sale, or sale) of Licensed Compounds and/or Licensed Products in accordance with this
Agreement. Licensor shall be responsible for providing one (1) set of copies (electronic, where they exist) only and Licensee
shall have no obligation to reformat or otherwise alter or modify any materials, or to create materials in electronic form, in
order to provide them to Licensee. Any and all materials and other Licensed Productys and Licensed Know-How delivered to Licensee
pursuant to this Section 3.1 are and shall remain the sole property of Licensor. 


Without
limiting the foregoing, if, within thirty (30) days after the Effective Date, if Licensee reasonably determines that there is
additional, specific Licensed Know-How Controlled by Licensor and its Affiliates that existed as of the Effective Date that is
reasonably necessary for the continued Development or manufacture (but only those manufacturing and formulation processes, techniques
and trade secrets used by Licensor for making such Licensed Products as of the Effective Date) of any Licensed Product that has
not been provided during the Know-How Transfer Period, then Licensee may request within such period that Licensor transfer to
Licensee such additional Licensed Know-How and Licensor will endeavor to locate and provide same, provided that Licensor shall
not be required to conduct an unreasonable search for any such additional Licensed Know-How. Licensor shall have no obligation
to reformat or otherwise alter or modify any materials, or to create materials in electronic form, in order to provide them to
Licensee.





3.1.2
Notwithstanding Sections 3.1.1 or 3.2, nothing herein shall require Licensor to transfer, disclose or provide to Licensee
(i) any reagents, assays or other tangible biological or chemical materials that are not listed on Exhibit A and, (ii) any
general information or know-how that should reasonably be known to a pharmaceutical company engaged in the research, development,
manufacture or commercialization of small molecule ligands. 


 


3.2
Technical Assistance. During the two year period following the Effective Date (the “TA Period”),
Licensor shall reasonably cooperate with Licensee to provide transition and technical assistance to Licensee in order to understand
and use the Licensed Know-How provided to Licensee under Section 3.1. Such cooperation shall include providing Licensee with
reasonable access by teleconference or in-person at Licensor’s facilities (subject to Licensor’s customary rules and
restrictions with respect to site visits by non-licensor personnel) to Licensor personnel who are appropriately qualified and
experienced for such purpose, directly involved in the research and Development or manufacture of Licensed Products.


 






    	 	15	 



     


    

 





3.6
Third Party Agreements. Licensor shall use Commercially Reasonable Efforts to promptly assign to Licensee any unexpired
Third Party agreements solely and exclusively related to the research and non-clinical Development of the Licensed Compound set
forth in Exhibit A and is assignable to Licensor without consent of such Third Party, provided, however, that if such Third Party
agreement is not assignable to Licensee without the written consent of such Third Party, Licensor shall use Commercially Reasonable
Efforts to obtain a consent to such assignment (but which shall not, for clarity, require Licensor to pay any termination fee
or additional consideration to the other party to such agreement).


 


3.7
Licensor Contractors. For clarity, references to Licensor in Article 3 and Article 4 shall include Third Party
contractors engaged by Licensor to perform services for the benefit of Licensor (i.e., Third Parties who receive limited rights
to perform services similar to other parties on a basis and on terms customarily understood for a vendor, such as a contract manufacturing
organization) who have entered into appropriate agreements protecting the confidentiality and proprietary nature of the Licensee
Know-How, Licensed Compounds, technical data and information and other Transferred Materials (as defined below) in accordance
with this Agreement, provided, that Licensor shall remain responsible and liable for the compliance by such individuals with the
terms of this Agreement and shall use Commercially Reasonable Efforts to require such Third Parties to assign to Licensor any
inventions and know-how relating to the License Compounds and Licensed Products that may be made or generated by them in the course
of their services for Licensor.


 


ARTICLE
4


TRANSFER
OF MATERIALS


 


4.1
Materials. Licensor shall initiate the transfer to Licensee (i) within the time period after the Effective Date
those Licensed Compounds identified in Exhibit A, (any such materials that are actually transferred, the “Transferred
Materials”). The Transferred Materials shall be transferred to Licensee at the location(s) designated by Licensee within
30 days after the Effective Date. Title and risk of loss shall be transferred to and borne by Licensor upon delivery of the Transferred
Materials by Licensee to a common carrier for shipment to Licensor, and Licensor shall be responsible for any indirect taxes levied
upon the transfer, including customs duties and import VAT if applicable.Other than the Transferred Materials, unless included
within the scope of Licensor Know-How and identified on Exhibit A and subject to Section 3.2, Licensor shall have no obligation
to provide Licensee with any compounds or other materials, such as assays or biomaterials, under this Agreement.


 


 


ARTICLE
5


DEVELOPMENT 


5.1
Development. Licensee shall itself or through its Affiliates or SubLicensees use Commercially Reasonable Efforts to
Develop Licensed Products for Approval in the Major Market Countries, including by (i) setting forth in the Development Plan
a program of Development activities and reasonable estimated timelines therefor for each phase of pre-clinical and clinical Development
for Licensed Compounds and Licensed Products (it being understood that such Development Plan may be revised as a result of input
from Regulatory Authorities and data generated by Licensee as it Develops Licensed Products), and (ii) assigning appropriately
qualified and experienced personnel to perform and monitor the progress of, or overseeing Third Parties who perform, such Development
activities on an on-going basis. The initial Development Plan as of the Effective Date is attached hereto as Exhibit A-1. During
the Term, Licensee shall promptly provide Licensor no later than January 31 of each Calendar Year with a copy of the revised
Development Plan (such annual updates to the Development Plan may be provided as part of the Development Report outlined in Section 5.2).
Licensee shall notify Licensor of any material change (including any material delay in Development or Commercialization of Licensed
Product) to the Development Plan last provided to Licensor within thirty (30) days after becoming aware of such material
change and the reasons therefor.





5.2
Development Reports. Licensee shall provide Licensor with written Development reports on or before January 31
of each Calendar Year during the term of Development activities summarizing such activities in sufficient detail to enable Licensor
to determine Licensee’s compliance with its diligence obligations in Section 5.1. Such reports shall include without
limitation (a) the research and other Development activities accomplished by Licensee under the existing Development Plan
through the end of the immediately preceding Calendar Year with respect to Licensed Compounds and Licensed Products, and (b) updates
on Licensee’s progress against the existing Development Plan; provided, however, that the first such report shall be due
on or before January 31, 2017. If any such Development obligations have been sublicensed to a SubLicensee, Licensor shall
require the SubLicensee to provide to Licensor the same information as required of Licensee hereunder with respect to the progress
of the Development of Licensed Compounds and Licensed Products by such SubLicensee. If requested by Licensor, Licensee (and, if
applicable, SubLicensee) personnel who prepared the report will meet with Licensor (which may be by teleconference) to discuss
and answer any reasonable questions or comments that Licensee might have on the report and Licensee’s (and, if applicable,
each of its SubLicensee’s) Development activities.








5.3
Records. Licensee shall maintain complete and accurate records of all work conducted in furtherance of the research,
Development and Commercialization of the Licensed Products and all results, data and developments made in furtherance thereof
to the extent required under applicable Laws. Such records shall properly reflect all work done and results achieved in sufficient
detail and in good scientific manner to the extent required under applicable Laws.





5.4
Development Responsibilities and Costs. As between the Parties, Licensee shall have sole responsibility for, and shall
bear the cost of conducting, research and Development with respect to the Licensed Compounds and/or Licensed Products. Licensee
shall research and Develop the Licensed Compounds and/or Licensed Products in compliance with all applicable Laws, including all
legal and regulatory requirements pertaining to the design and conduct of clinical studies.









    	 	16	 



     


    

5.5
Regulatory Responsibilities and Costs. As between the Parties, Licensor shall have sole responsibility for, and shall
bear the cost of preparing, all regulatory filings and related submissions with respect to the Licensed Compounds and/or Licensed
Products. Except as set forth in Article 13, Licensor shall own all INDs, Approvals and submissions in connection therewith and
all Approvals shall be obtained by and in the name of Licensor.


 


5.6
Competitive Compound.





5.6.1
For five (5) years after the Effective Date, neither Licensee nor its Affiliates (nor any SubLicensee of Licensee or any Affiliate
of such SubLicensee) shall itself or through any Third Party, or in collaboration with any Third Party, engage, directly or indirectly
in the clinical Development or Commercialization of a Competitive Compound.





5.6.2
Notwithstanding Section 5.6.1, if Licensee or any of its Affiliates, either through its own development efforts or by
acquisition, or obtains ownership of or a license to, or is acquired by or otherwise merges with an entity (or an Affiliate of
such entity) that owns or has a license to, a Competitive Compound, in all such cases that would result in a violation of Section 5.6.1
(any such event, a “Triggering Event”), then Licensee shall promptly notify Licensor in writing and elect (as
applicable) one of the following actions within 10 days after such Triggering Event:





 


(a)
divest itself of such Competitive Compound and notify Licensor in writing of such divestiture, which divestiture may occur
by an outright sale to a Third Party of all of Licensor’s and its Affiliate’s rights to such Competitive Compound
or by an outlicense arrangement under which Licensor has no continuing active involvement in the development or commercialization
of such Competitive Compound (for clarity, efforts in connection with (i) the receipt and audit of payments in respect of
the Competitive Compound, (ii) the maintenance, defense and enforcement of any applicable licensed patents, and (iii) the
receipt of information to ensure compliance with the applicable agreement (including efforts to enforce or terminate same, or
seek damages, for breach) shall not constitute continuing active involvement). Licensor shall use Commercially Reasonable Efforts
to complete such divestiture within 10 days after the applicable Triggering Event. If Licensee is unable to complete the divesture
within such 10 day period, Licensee may continue to divest such Competitive Compound thereafter, provided, that Licensee
or its Affiliate shall cease the Development and Commercialization of the Competitive Compound prior to the end of such 30 day
period and shall not restart the Development and Commercialization of the Competitive Compound thereafter (and if such Development
or Commercialization is restarted, then Licensor may immediately terminate this Agreement upon written notice to Licensee). For
clarity, Licensee’s (or its Affiliates’) Development and Commercialization of the Competitive Compound in the ordinary
course during such 30 day period shall not be deemed a breach of Licensee’s exclusivity obligations set forth herein; or


 






    	 	17	 



     


    

 


(b)
Licensor shall notify LICENSEE in writing whether Licensor desires to negotiate terms under which the Competitive Compound
would be included as a Product within this Agreement. If the Parties can agree and execute a binding agreement, within 30 days
after notice from Licensor electing this option, on the terms for including the Competitive Compound as a Product within this
Agreement and Licensor’s Commercially Reasonable Efforts obligations under Sections 5.1 and 6.1, then Licensee shall not
be deemed in breach of Section 5.6.1.. If the Parties are unable to reach written agreement during the applicable time period,
or if the Licensee refuses to divest the Competitive Compound, then the Licensor may elect to terminate this Agreement pursuant
to Section 13.3.2 hereof.


 


 


ARTICLE
6


 


COMMERCIALIZATION


 


6.1
Licensor Obligations. Licensee shall use Commercially Reasonable Efforts to (i) obtain Approvals in each Major
Market Country for at least one Licensed Product, (ii) effect the First Commercial Sale of each Licensed Product for which
such Approvals are obtained into each Major Market Country as soon as reasonably practicable after receipt of such Approvals and
(iii) Commercialize each such Licensed Product in each such Major Market Country following such First Commercial Sale therein
with the goal of maximizing the Net Sales of such Licensed Product in such Major Market Country.





6.2
Reports. Following the First Commercial Sale of a Licensed Product in a country in the Territory, Licensee shall provide
Licensor with a written report within thirty (30) days of the filing of the Licensor Annual Report with the U.S. Securities
and Exchange Commission (or if no such report is filed, then within 30 days after the end of a calendar year), summarizing significant
Commercialization activities with respect to Licensed Products during the just ended Calendar Year in countries in which there
has been a First Commercial Sale of a Licensed Product. If requested by Licensor, Licensee personnel who prepared the report will
meet with Licensor, which may be by teleconference, to discuss and answer any questions or comments that Licensor might have on
the report and Licensee’s Commercialization activities.


 


ARTICLE
7


 


7.1       Omitted


 


ARTICLE
8


 


FINANCIAL
TERMS


 


In
partial consideration of the rights granted by Licensor to Licensee pursuant to this Agreement, Licensee shall make the payments
provided for in this Article 8.


 


8.1
Initial Payment. No initial payment is required by Licensor from Licensee..









    	 	18	 



     


    

8.2
Milestone Payments.


 


8.2.1
Development Milestones. Licensee shall pay to Licensor milestone payments set forth in Exhibit B.


 


8.2.2
Sales-Based Milestones. Licensee shall pay to Licensor such payments as set forth in Exhibit B.





8.3
Sublicense Revenue Sharing. In addition to the milestones and royalty payments set forth in Sections 8.2 and 8.4, Licensee
shall pay to Licensor revenue sharing payments as set forth in Exhibit B.


 


8.4
Royalty Payments.


 


8.4.1
Subject to the terms of this Agreement Licensee shall pay to Licensor tiered royalties based on the total annual worldwide
Net Sales in the Territory of each Licensed Products (including all indications and formulations for such Licensed Product) by
Licensee, its Affiliates and Sub-Licensees during the applicable Royalty Term for such Licensed Product. The royalty payable with
respect to each particular Licensed Product shall be calculated by multiplying the applicable royalty rate below by the portion
of total annual worldwide Net Sales in the applicable tier in a Calendar Year of the applicable Licensed Product by Licensee,
its Affiliates and Sub-Licensees, as set forth in Exhibit B


 


8.4.2
Royalty Term. Royalties shall be payable on a product-by-product and country-by-country basis on Net Sales of Licensed
Products from the First Commercial Sale of a particular Licensed Product in a country as set forth in Exhibit B.


 


8.4.3
Royalty Conditions. The royalties under Section 8.4.1 shall be subject to the following conditions:


 


(a)
only one royalty shall be due with respect to the same unit of Licensed Product;


 


(b)
no royalties shall be due upon the sale or other transfer among any Related Party, but in such cases the royalty shall be
due and calculated upon the Related Party’s Net Sales of Licensed Product to the first non-Related Party; and


 


(c)
no royalties shall accrue on the disposition of Licensed Product in reasonable quantities by any Related Party as part of
an expanded access program or as bona fide samples or as donations to non-profit institutions or government agencies for
non-commercial purposes or for the performance of clinical trials, provided, in each case, that such Related Party does
not receive any payment for such Licensed Product exceeding the cost of goods.


 






    	 	19	 



     


    

 


8.4.4
Royalty Reduction. There is no royalty reduction in the event (i) Licensee, in its reasonable judgment, determines
that it is required to obtain a license from any Third Party in order to avoid infringement of such Third Party’s Patent
Rights as a result of the Development or Commercialization (but excluding manufacturing) of any Licensed Product, (ii) such
Patent Rights cover or claim the composition or method of use of a Licensed Product, and (iii) Licensee is required to pay
to such Third Party a royalty, milestone payments or other monetary compensation in consideration for the grant or maintenance
of such license (“Third Party Compensation”).


 


8.4.5
Forecast. Licensee shall provide on or before September 30 of each Calendar Year a non-binding good faith forecast
of sales, royalties and milestones for the entire current and next Calendar Year.


 


8.4.6
Effect of Patent Challenge. In the event Licensee (or any of its Affiliates or Sub-Licensees) challenges or knowingly
assists (other than in response to a subpoena or court order), including without limitation by providing information, documents,
advice, and/or funding, a challenge to the validity, scope, patentability or enforceability of any of the Licensor Patent Rights,
Licensor may immediately terminate the license.





8.5
Manner of Payment. All payments to be made by Licensee under this Agreement shall be made in U.S. Dollars by wire transfer
of immediately available funds to such bank account as shall be designated by Licensor. Late payments shall bear interest at the
rate provided in Section 8.10.





8.6
Sales Reports and Royalty Payments. After the First Commercial Sale of a Licensed Product and during the term of this
Agreement, Licensee shall furnish to Licensor a written report, within thirty (30) days after the end of each Calendar Quarter
(or portion thereof, if this Agreement terminates during a Calendar Quarter), showing the amount of royalty due for such Calendar
Quarter (or portion thereof). Royalty payments for each Calendar Quarter shall be due at the same time as such written report
for the Calendar Quarter. With each quarterly payment, Licensor shall deliver to Licensor a full and accurate accounting to include
at least the following information:


 


8.6.1
the total gross sales for each Licensed Product (by country) by Licensee and its applicable Related Parties, if any, and the
calculation of Net Sales from such gross sales;


 


8.6.2
the deductions by category of permitted deductions set forth in the Net Sales definition;


 


8.6.3
the total Net Sales for each Licensed Product (by country) by Licensee and its applicable Related Parties, if any, and the
calculation of Net Sales from such gross sales;


 


8.6.4
the calculation of royalties payable in Dollars which shall have accrued hereunder in respect of such Net Sales;


 






    	 	20	 



     


    

 


8.6.5
withholding taxes, if any, required by applicable Law to be deducted in respect of such royalties; and


 


8.6.6
the exchange rates used in determining the amount of Dollars payable hereunder.


 


If
no royalty or payment is due for any royalty period hereunder, Licensee shall so report.


 


8.7
Sales Record Audit.


 


8.7.1
Licensee shall keep, and shall cause each of its applicable Related Parties, if any, to keep, complete, true and accurate
books of accounts and records in accordance with GAAP, including gross sales in accordance with GAAP and any deductions thereto
in accordance with this Agreement’s Net Sales definition in connection with the calculation of Net Sales, sufficient to
determine and establish the amounts payable incurred under this Agreement, and compliance with the other terms and conditions
of this Agreement.


 


8.7.2
Such books of accounting of Licensee and its Affiliates shall be kept at their principal place of business and, with all necessary
supporting data and records, shall during all reasonable times for the next 12 months following the end of the Calendar Year to
which each shall pertain, be open for inspection at reasonable times by an independent certified public accountant selected by
Licensor and as to which Licensee has no reasonable objection, at Licensor’s expense, for the purpose of verifying royalty
statements and payments for compliance with this Agreement for any period within the preceding three (3) years.


 


8.7.3
Licensee shall include in its Sublicense Agreements with any Sub-Licensees, a right for Licensee to inspect or have such an
accountant inspect the books of accounting and such supporting data and records of such Sub-Licensees for the purpose of verifying
royalty statements and payments for compliance with this Agreement for any period within the preceding three (3) years.


 


8.7.4
Results of any inspection under Section 8.7.2 or 8.7.3 shall be made available to both Licensor and Licensee, and shall
be deemed Licensor’s Confidential Information under this Agreement; provided that the independent, certified public accountant
shall disclose to Licensor only the amounts that the independent auditor believes to be due and payable hereunder to Licensor,
details concerning any discrepancy from the amount paid (including the reasons therefor) and the amount due, and shall disclose
no other information revealed in such audit.


 


8.7.5
Such accountant must have agreed in writing to maintain all information learned in confidence, except as necessary to disclose
to Licensor such compliance or noncompliance by Licensee, its Affiliates or Sub-Licensees (who must agree in the Sublicense Agreement
that such audit report may be disclosed to Licensor). The results of each inspection, if any, shall be binding on both Parties.
Licensor shall pay for such inspections. Any underpayments shall be paid by Licensee within three (3) months after notification
of the results of such inspection. Any overpayments shall be fully creditable against amounts payable in subsequent payment periods.


 






    	 	21	 



     


    

 


8.8
Currency Exchange. Licensee’s then current standard exchange rate methodology will be employed for the translation
of foreign currency sales into Dollars, provided such methodology is used by Licensee in the translation of its foreign currency
operating results, is consistent with GAAP, and is audited by Licensee’s independent certified public accountants in connection
with the audit of the consolidated financial statements of Licensee, and is used for Licensee’s external reporting of foreign
currency operating results.


 


8.9
Taxes.


 


8.9.1
Each Party will pay any and all taxes levied on account of all payments it receives under this Agreement.


 


8.9.2
If laws or regulations require that taxes be withheld with respect to any royalty payments by Licensee to Licensor under this
Agreement, Licensor will: (a) deduct those taxes from the remittable payment, (b) pay the taxes to the proper taxing
authority, and (c) send evidence of the obligation together with proof of tax payment to Licensor on a reasonable and timely
basis following that tax payment. Each Party agrees to cooperate with the other Party in claiming refunds or exemptions from such
deductions or withholdings under any relevant agreement or treaty which is in effect. The Parties shall discuss applicable mechanisms
for minimizing such taxes to the extent possible in compliance with applicable Laws. Licensor will pay any and all taxes levied
on account of all payments it receives under this Agreement.


 


8.9.3
The Parties shall cooperate in accordance with applicable Laws to minimize indirect taxes (such as value added tax, sales
tax, consumption tax and other similar taxes) in connection with this Agreement


 


8.10
Interest Due. Without limiting any other rights or remedies available to Licensor, Licensee shall pay Licensor interest
on any payments that are not paid on or before the date such payments are due under this Agreement at a rate of ten percent (10%)
per annum (simple interest) or the maximum applicable legal rate, if less, calculated on the total number of days payment is delinquent.


 






    	 	22	 



     


    

 


ARTICLE
9


 


REPRESENTATIONS
AND WARRANTIES; DISCLAIMER;


LIMITATION
OF LIABILITY


 


9.1
Mutual Representations and Warranties. Each Party represents and warrants to the other Party that, as of the Effective
Date: (i) it is duly organized, validly existing and in good standing under the Laws of the jurisdiction of its incorporation
and has all requisite corporate power and authority to enter into this Agreement and to perform its obligations under this Agreement,
(ii) execution of this Agreement and the performance by such Party of its obligations hereunder have been duly authorized,
(iii) this Agreement has been duly executed and delivered on behalf of such Party, and is legally binding and enforceable
on each Party in accordance with its terms, (iv) the performance of this Agreement by it does not create a breach or default
under any other agreement to which it is a Party, (v) the execution, delivery and performance of this Agreement by such Party
does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound,
nor violate any Law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such
Party, (vi) no government authorization, consent, approval, license, exemption of or filing or registration with any court
or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any Laws currently
in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement or any other agreement
or instrument executed in connection herewith, or for the performance by it of its obligations under this Agreement and such other
agreements, and (vii) neither such Party, nor any of its employees, officers, subcontractors, or consultants who have rendered
services relating to the Licensed Compounds: (a) has ever been debarred or is subject to debarment or convicted of a crime
for which an entity or person could be debarred by the FDA under 21 U.S.C. Section 335a or (b) has ever been under indictment
for a crime for which a person or entity could be so debarred.


 


9.2
Representations, Warranties, and Covenants of Licensor. Except as set forth in Exhibit C to this Agreement:


 


9.2.1
Licensor represents and warrants to Licensee that, as of the Effective Date:


 


(a)
there is no pending litigation, or litigation that has been threatened in writing, which alleges, or any written communication
alleging, that Licensor’s activities with respect to the research, Development or manufacture of the Licensed Compounds
prior to the Effective Date have infringed or misappropriated, or would infringe or misappropriate, any of the intellectual property
rights of any Third Party, and to Licensor’s Knowledge, the research, Development or manufacture of the Licensed Compounds
prior to the Effective Date did not infringe or misappropriate any Third Party rights.


 


(b)
no Third Party has challenged in writing the ownership, scope, duration, validity, enforceability, priority or right to use
any Licensor Patent Rights (including, by way of example, through the institution of or written threat of institution of interference,
inter partes review, reexamination, protest, opposition, nullity or similar invalidity proceeding before the United States
Patent and Trademark Office or any foreign patent authority or court) or Licensor Know-How,


 






    	 	23	 



     


    

 


(c)
there is no actual, pending, or, to Licensor’s Knowledge, alleged or threatened in writing, adverse interferences or
governmental investigations or suits involving the Licensed Compounds;


 


(d)
no Licensor Patents or Licensor Know-How has been licensed to Licensee from any Third Party that Licensor does not Control
and which is material to the Development of the Licensed Compound as contemplated by the Development Plan;


 


(e)
to Licensor’s Knowledge, it has complied with all applicable Laws in the Development of the Licensed Compounds prior
to the Effective Date;


 


(f)
except for the patent and patent applications that have been abandoned prior to the Effective Date, all fees required to be
paid by Licensor in any jurisdiction in order to maintain the Patent Rights licensed to Licensee hereunder have, to Licensor’s
Knowledge, been timely paid as of the Effective Date and, to Licensor’s Knowledge, the claims included in any issued patents
included in such Patent Rights are in full force and effect as of the Effective Date;


 


(g)
Licensor has full unencumbered title to the Transferred Material and sufficient right under the Licensed Patent Rights and
Licensor Know-How to grant the licenses to Licensee as purported to be granted hereunder, and has not previously assigned, transferred,
conveyed, or granted any license or other rights to its right, title and interest in the Licensed Patent Rights or the Licensor
Know-How, in any way that would materially conflict with or materially limit the scope of any of the rights or licenses granted
to Licensor hereunder;


 


(h)
Licensor solely owns all the rights, title and interest in the Licensed Patent Rights and the Licensed Patent Rights are free
of any lien or security interest;


 


(i)
except as set forth in Exhibit A, Licensor and its Affiliates do not own or control any other Patent Rights that are necessary
or, to Licensor’s Knowledge and reasonable belief as of the Effective Date, reasonably useful to carry out the Development
(including manufacture) of Licensed Compounds and/or Licensed Products as contemplated by the Development Plan attached as Exhibit
B hereto; and


 


(j)
subject to Section 3.1.2, to Licensor’s Knowledge, the documents, data and information that are included in the
Licensor Know-How transferred to Licensee pursuant to Section 3.1 comprise all of the Know-How Controlled by Licensor that
is reasonably necessary for the manufacture of Licensed Property.


 


9.2.2
Licensor covenants that it shall not license, sell, assign or otherwise transfer to any person (including any Affiliate of
Licensor) any Licensed Property or any Licensed Know-How, or assign or otherwise transfer any of its rights or obligations thereunder
to any person (including any Affiliate of Licensor) (or offer or agree to do any of the foregoing) in any manner that would have
a material adverse impact on the rights granted to Licensee under this Agreement, except to the extent permitted by, and in compliance
with, Section 15.4.


 






    	 	24	 



     


    

 


In
addition, Licensor hereby covenants and agrees that after the Effective Date Licensor shall use commercially reasonable efforts
to not incur or permit to exist (and to cause each of its Affiliates not to incur or permit to exist), with respect to any Licensed
Property or any Licensed Know-How, any lien, encumbrance, or security interest (including in connection with any indebtedness)
in any manner that would have a material adverse impact on the rights granted to Licensee under this Agreement, except to the
extent permitted by, and in compliance with, Section 15.4.


 


9.3
Representations and Warranties of Licensee. Licensee represents, warrants and covenants that:


 


9.3.1
it shall not engage in any activities that use the Licensed Patent Rights and/or Licensed Know-How in a manner that is outside
the scope of the license rights granted to it hereunder,


 


9.3.2
all of its activities related to its use of the Licensed Patent Rights and Licensed Know-How, and the research, Development
and Commercialization of the Licensed Compounds and/or Licensed Products, pursuant to this Agreement shall comply with all applicable
Law,


 


9.3.3
Licensor shall have all licenses that are necessary in order for the manufacture, use or sale of such Licensed Product not
to infringe the intellectual property of any Third Party known to Licensor as of such date, but excluding licenses applicable
to any Third Party issued patents for which Licensor shall have obtained a well-reasoned, written opinion of an outside patent
attorney that Licensor’s activities under the scope of this Agreement are not reasonably likely to infringe any Valid Claim
of such Third Party issued patent, and


 


9.3.4
Licensor shall make available funds necessary to consummate the transaction contemplated by this Agreement and to Develop
and Commercialize the Licensed Compounds and Licensed Products in accordance with the terms of this Agreement.


 


9.4
DISCLAIMER. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES
OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE WITH RESPECT TO ANY LICENSED COMPOUNDS, LICENSED PRODUCTS, TRANSFERRED MATERIALS, THE LICENSEE PATENT RIGHTS OR LICENSEE
KNOW-HOW OR ANY RIGHT OR LICENSE GRANTED BY LICENSEE HEREUNDER, AND NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION
OR WARRANTY BY LICENSEE THAT ANY PATENT OR OTHER PROPRIETARY RIGHTS INCLUDED IN THE LICENSEE PATENT RIGHTS ARE VALID OR ENFORCEABLE
OR THAT USE OF THE LICENSEE PATENT RIGHTS, LICENSEE KNOW-HOW AND TRANSFERRED MATERIALS CONTEMPLATED HEREUNDER DOES NOT INFRINGE
ANY PATENT RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY.


 






    	 	25	 



     


    

 


9.5
Limitation of Liability. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT OR OTHERWISE, NEITHER PARTY SHALL BE LIABLE TO
THE OTHER WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT, WHETHER UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER
LEGAL OR EQUITABLE THEORY, FOR ANY INCIDENTAL, INDIRECT, SPECIAL, EXEMPLARY, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES (INCLUDING,
WITHOUT LIMITATION, LOST PROFITS, LOSS OF USE, DAMAGE TO GOODWILL, OR LOSS OF BUSINESS), AND IN ANY CASE, LICENSEE SHALL NOT BE
LIABLE FOR ANY DAMAGES OF ANY KIND (INCLUDING DIRECT DAMAGES) IN AN AMOUNT GREATER THAN THE AMOUNTS PAID BY LICENSOR TO LICENSEE
UNDER SECTIONS 8.1 AND 8.2 OF THIS AGREEMENT; PROVIDED, HOWEVER, THAT THE FOREGOING SHALL NOT APPLY TO ANY BREACH BY A
PARTY OF ARTICLE 11 HEREOF, TO A BREACH BY LICENSOR OF SECTION 5.6, WILLFUL MISCONDUCT BY A PARTY, OR FOR AMOUNTS SOUGHT BY THIRD
PARTIES IN CLAIMS THAT ARE SUBJECT TO THE PARTIES’ RESPECTIVE INDEMNITY OBLIGATIONS UNDER ARTICLE 12. FOR THE AVOIDANCE
OF DOUBT, ANY DAMAGES IN THE NATURE OF LOST ROYALTIES TO LICENSEE SHALL BE CONSIDERED DIRECT DAMAGES.





 


ARTICLE
10


PATENT
MAINTENANCE; INFRINGEMENT; PATENT EXTENSIONS


 


10.1
Inventions. Inventorship of inventions conceived or reduced to practice in the course of Development activities under
this Agreement shall be determined by application of United States patent Laws pertaining to inventorship. If such inventions
are jointly invented in the course of Development activities by one or more employees or consultants or contractors of both Parties,
such inventions shall be jointly owned (“Joint Invention”), and if one or more claims included in an issued
patent or pending patent application which is filed in a patent office in the Territory claim such Joint Invention, such patent
or patent application shall be jointly owned (“Joint Patent Rights”). If such an invention is solely invented
by an employee or consultant of a Party, such invention shall be solely owned by such Party, and any patent filed claiming such
solely owned invention shall also be solely owned by such Party. This Agreement shall be understood to be a joint research agreement
in accordance with 35 U.S.C. § 102(c) to develop the Licensed Property. Each Party shall enter into binding agreements
obligating all employees and consultants performing activities under or contemplated by this Agreement, including activities related
to the Licensed Property, Licensed Compounds or Licensed Products, to assign his/her interest in any invention conceived or reduced
to practice in the course of such activities to the Party for which such employee or consultant is providing its services. With
respect to contractors, Licensor shall use good faith and reasonable efforts to secure an agreement from such contractor to assign
or license (with the right to sublicense) to Licensor inventions (and patent rights covering such inventions) made by such contractor
in performing such services for Licensor.


 






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10.2
Filing, Prosecution and Maintenance of Licensor Patent Rights. Licensor will have lead responsibility, using its in-house
patent counsel or outside patent counsel selected by Licensor (such determination and outside patent counsel selection to be subject
to Licensee’s approval, such approval not to be unreasonably withheld), for the preparation, prosecution (including any
interferences, reissue proceedings and reexaminations) and maintenance of the Licensed Patent Rights. Licensor shall be responsible
for the costs incurred with respect to the filing, prosecution and maintenance of the Licensed Patent Rights. Licensor shall provide
Licensee with quarterly updates of the filing, prosecution and maintenance status for each of the Licensed Property and Licensed
Patent Rights, and shall promptly provide copies of any material official correspondence to or from patent offices. The Parties
shall reasonably consult with each other and cooperate with respect to the preparation, prosecution and maintenance of the Licensed
Patent Rights, including by providing assistance as described in Section 3.2, and will confer regarding where to prosecute
the Licensed Patent Rights. Licensee shall not take any action during prosecution and maintenance of the Licensed Patent Rights
that would materially adversely affect them (including reduction in claims scope), without Licensor’s prior express written
consent (which consent shall not be unreasonably withheld, delayed or conditioned and shall be considered to be given if Licensee
notifies Licensor of proposed claim amendments or cancellations and Licensor fails to object within 30 days of such notification).
Licensee may file a notice with governmental patent offices of the exclusive license to the Licensor Patent Rights granted to
Licensee hereunder. Post-grant proceedings involving the Licensor Patent Rights, including oppositions, cancellations, inter
partes review, and the like, shall be conducted by Licensor at the expense of Licensor, and Licensor shall promptly notify
Licensee of the initiation of such proceeding (or vice versa) and Licensor shall give Licensee the opportunity to participate,
at the sole expense of Licensee, and Licensor shall also participate and appear as necessary under the applicable rules governing
the proceeding. Any settlement or compromise of such post-grant proceeding shall be subject to the approval of Licensor, which
approval shall not be unreasonably withheld, delayed or conditioned.


 


10.3
Patent Abandonment.


 


10.3.1
The Parties will confer and must mutually agree before any of the Licensed Property, Licensed Patent Rights or both of them
may be abandoned in any Major Market Country; provided that Licensee shall not unreasonably withhold, delay or condition its consent
to a request by Licensor to abandon a Licensed Property, Licensed Patent Right or both of them if such abandonment will not adversely
affect the amount or duration of any royalty payable to Licensor hereunder. Licensor shall provide Licensee with notice of the
allowance and expected issuance date of any patent within the Licensed Property and Licensed Patent Rights, or any of the deadline
for filing a new patent application, and Licensor shall provide Licensee with prompt notice as to whether Licensor desires Licensee
to file such new patent application.


 


10.3.2
Subject to Section 10.3.1, in the event that Licensor decides either (a) not to continue the prosecution or maintenance
of a patent application or patent within the Licensed Patent Rights in any country, or (b) not to file any new patent application
requested to be filed by Licensor, Licensor shall provide Licensee with express written notice of this decision at least thirty
(30) days prior to any pending lapse or abandonment thereof, or if a decision not to continue prosecution or maintenance is responsive
to an official communication from governmental agency that is received by Licensor less than thirty (30) days prior to a deadline
for taking action in response thereto, then the deadline for giving such notice to Licensee shall be ten (10) days of the time
remaining for response after such communication is received by Licensor. In such event, provided that the Parties have not expressly
agreed to abandon a patent or not file a patent application under Section 10.3.1, then Licensor shall provide Licensee with
an opportunity to assume responsibility for all external costs reasonably associated with the filing and/or further prosecution
and maintenance of such patent application and any patent issuing thereon (such filing to occur prior to the issuance of the patent
to which the application claims priority or expiration of the applicable filing deadline, as set forth above). In the event that
Licensee assumes such responsibility for such filing, prosecution and maintenance costs, Licensor shall transfer the responsibility
for such filing, prosecution and maintenance of such patent applications and patents to Licensee and Licensee shall no longer
have any right or license in and to such patent application and patents issuing therefrom under this Agreement.


 



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10.4
Enforcement of Licensor Patent Rights against Infringers.


 


10.4.1
Enforcement by Licensor. In the event that Licensor or Licensee becomes aware of a suspected infringement of any Licensed
Property, Licensed Patent Right or any of them in the Field, including actual or alleged infringement under 35 USC §271(e)(2)
that is or would be infringing activity involving the using, making, importing, offering for sale or selling of articles that
the Party reasonably believes infringes any of the Patent Rights conferred under this Agreement, such Party shall notify the other
Party promptly, including all information available to such Party with respect to such alleged infringement, and following such
notification, the Parties shall confer. Licensee shall have the first right, but shall not be obligated, to bring an infringement
action for suspected infringement in the Field at its own expense, in its own name and entirely under its own direction and control,
subject to the following: (a) Licensor shall reasonably assist Licensee (at Licensee’s expense) in any action or proceeding
being prosecuted for suspected infringement in the Field if so requested, including by being named or joined as a plaintiff to
such actions or proceedings if requested by Licensee or required by Law, (b) Licensor shall have the right to participate
and be represented in any such suit by its own counsel at its own expense, (c) no settlement of any such action or proceeding
which restricts the scope, or adversely affects the enforceability, of any Licensed Property, Licensed Patent Right or any of
them in the Field may be entered into by Licensee without the prior written consent of Licensor, which consent shall not be unreasonably
withheld, delayed or conditioned, and further, no settlement of any such action or proceeding which pertains to the infringement
of the Licensor Patent Rights by virtue of the Development or Commercialization of a Licensed Compound in the Field by a Third
Party that is not a Sub-Licensee may be entered into by Licensee without the prior written consent of Licensor, which consent
shall not be unreasonably withheld, delayed or conditioned.


 


10.4.2
Timing; Enforcement by Licensee. Licensee will have a period of thirty (30) days after its receipt or delivery of notice
and evidence pursuant to Section 10.4.1 or receipt of written notice from a Third Party that reasonably evidences such infringement
of the Licensed Patent Rights, to elect to so enforce such Licensed Patent Rights in the applicable jurisdiction (or to settle
or otherwise secure the abatement of such infringement in accordance with Section 10.4.1), provided however, that such period
will be (i) more than ten (10) days to the extent applicable Law prevents earlier enforcement of such Licensed Patent Right
(such as the enforcement process set forth in or under the Hatch-Waxman Act), and provided further that if such period is extended
because applicable Law prevents earlier enforcement, Licensee shall have until the date that is fifteen (15) days following the
date upon which applicable Law first permits such proceeding, and (ii) less than thirty (30) days to the extent that a delay
in bringing such proceeding against such alleged Third Party infringer would materially limit or compromise the remedies (including
monetary relief, and stay of regulatory approval) available against such alleged Third Party infringer. In the event Licensee
does not so elect (or settle or otherwise secure the abatement of such infringement) before the first to occur of (A) the
expiration of the applicable period of time set forth in the preceding subsections (i) and (ii), or (B) other such time as
identified in writing to Licensee from Licensor before the expiration of any time period under applicable Law, that would, if
a proceeding was not filed within such time period, limit or compromise the remedies available from such proceeding, it will so
notify Licensor in writing and in the case where Licensor then desires to commence a suit or take action to enforce the applicable
Licensed Patent Right in the applicable jurisdiction, Licensor will thereafter have the right to commence such a suit or take
such action to enforce the applicable Licensed Patent Right, as applicable, at Licensor’s expense, provided that Licensor
shall first consult with Licensee concerning the reasons Licensee elected not to bring such action and shall consider those reasons
in good faith in deciding whether to bring such action. Licensee shall reasonably assist Licensor (at Licensor’s expense)
in any action or proceeding being prosecuted if so requested, including by being named or joined as a plaintiff to such actions
or proceedings if requested by Licensor or required by Law. Licensee shall have the right to participate and be represented in
any such suit by its own counsel at its own expense. No settlement of any such action or proceeding which restricts the scope,
or adversely affects the enforceability, of a Licensed Patent Right may be entered into by Licensor without the prior written
consent of Licensee, which consent shall not be unreasonably withheld, delayed or conditioned.


 






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10.4.3
Withdrawal. If either Party brings an action or proceeding under this Section 10.4 and subsequently ceases to
pursue or withdraws from such action or proceeding, it shall promptly notify the other Party and the other Party may substitute
itself for the withdrawing Party under the terms of this Section 10.4.


 


10.4.4
Damages. In the event that either Party exercises the rights conferred in this Section 10.4 and recovers any damages
or other sums in such action, suit or proceeding or in settlement thereof, such damages or other sums recovered shall first be
applied to all reasonable out-of-pocket costs and expenses incurred by the Parties in connection therewith, including attorneys’
fees.


 


10.5
Infringement of Third Party Rights


 


10.5.1
The Parties will promptly notify each other of any allegation that any activity under this Agreement infringes or may infringe
the intellectual property rights of any Third Party.


 


10.5.2
In any legal allegation related to the infringement of a Third Party intellectual property right, Licensor will have the first
right to control, at its expense, the defense of such allegation. Licensor will have the right, at its own expense and with its
own choice of counsel, to be represented in the defense of the allegation.


 


10.5.3
The Parties will reasonably cooperate with each other in all respects with all matters related to the defense of any legal
allegation under this section.


 


10.6
Patent Term Extensions. Licensee and Licensor shall each reasonably cooperate with one another and shall use Commercially
Reasonable Efforts in obtaining patent term extension (including any pediatric exclusivity extensions as may be available) or
supplemental protection certificates or their equivalents in any country with respect to Patent Rights covering the Licensed Products.
If elections with respect to obtaining such patent term extensions are to be made, Licensor shall have the right, at its discretion,
to make the election to seek patent term extension or supplemental protection with respect to the Patent Right for which such
extension or supplemental protection should be sought, provided that Licensee shall use Commercially Reasonable Efforts
to make such election so as to maximize the period of marketing exclusivity for the Licensed Product. For such purpose, for all
Approvals Licensor shall provide Licensee with written notice within thirty (30) calendar days following receipt of each Approval.
Notification of the receipt of an Approval shall be in accordance with Section 15.2 except that the notification shall be
sent to:


 


Regen
BioPharma Inc.


4700
Spring Street, Suite 304


La
Mesa, CA 91942


 


CheckPoint
Immunology Inc.


4700
Spring Street, Suite 304


La
Mesa, CA 91942


 


10.7
Notification of Patent Certification. Licensee shall notify and provide Licensor with copies of any allegations of
alleged patent invalidity, unenforceability or non-infringement of a Licensed Patent Right by a Third Party filing a bioequivalent
or biosimilar application or other similar patent certification or filing, and any foreign equivalent thereof. Such notification
and copies shall be provided to Licensor within ten (10) calendar days after Licensee receives such certification, and shall be
sent to the address set forth in Section 10.6. In addition, upon request by Licensor, Licensee shall provide reasonable assistance
and cooperation (including making available to Licensor documents possessed by Licensee that are reasonably required by Licensor
and making available personnel for interviews and testimony), at Licensor’s cost, in any actions reasonably undertaken by
Licensor to contest any such patent allegation or certification.


 






    	 	29	 



     


    

 


10.9
No Conflict Actions. Licensor shall not be required to take any action that Licensor reasonably determines in its sole
judgment and discretion conflicts with or violates any court or government order or decree that Licensee is then subject to or
otherwise may create legal liability on the part of Licensee.


 


10.10
Assignment of Licensed Patent Rights to a Licensor Affiliate. Notwithstanding any provision in this Agreement to the
contrary, Licensor shall have the right to transfer or assign ownership of any Licensed Patent Rights to a Licensor Affiliate
as long as any such transfer or assignment is made expressly subject to and assumption in writing of the rights, obligations and
licenses granted to Licensor under this Agreement. Licensor shall remain responsible for the compliance by such Affiliate with
the terms of this Agreement.


 


 


ARTICLE
11


NONDISCLOSURE
OF CONFIDENTIAL INFORMATION


 


11.1
Nondisclosure. Each Party agrees that, for so long as this Agreement is in effect and for a period of five (5) year
thereafter, a Party receiving Confidential Information of the other Party (or that has received any such Confidential Information
from the other Party prior to the Effective Date under the CDA) shall (i) maintain in confidence such Confidential Information
using not less than the efforts such Party uses to maintain in confidence its own proprietary industrial information of similar
kind and value, (ii) not disclose such Confidential Information to any Third Party without the prior written consent of the
other Party, except for disclosures expressly permitted below, and (iii) not use such Confidential Information for any purpose
except those permitted by this Agreement (which includes the performance of its obligations and the exercise of its rights under
this Agreement, but it being understood that this clause (iii) shall not create or imply any rights or licenses not expressly
granted under Article 2).


 


11.2
Exceptions. The obligations in Section 11.1 shall not apply with respect to any portion of the Confidential Information
that the receiving Party can show by competent proof:


 


11.2.1
is publicly disclosed by the disclosing Party, either before or after it is disclosed to the receiving Party hereunder; or


 


11.2.2
was known to the receiving Party or any of its Affiliates, without any obligation to keep it confidential or any restriction
on its use, prior to disclosure by the disclosing Party; or


 


11.2.3
is subsequently disclosed to the receiving Party or any of its Affiliates by a Third Party lawfully in possession thereof
and is disclosed without any obligation to keep it confidential or any restriction on its use; or


 


11.2.4
is published by a Third Party or otherwise becomes publicly available or enters the public domain, either before or after
it is disclosed to the receiving Party, other than through the receiving Party’s breach of its confidentiality obligations
set forth herein; or


 






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11.2.5
has been independently developed by employees or contractors of the receiving Party or any of its Affiliates without the aid,
application or use of Confidential Information of the disclosing Party.


 


11.3
Authorized Disclosure. The receiving Party may disclose Confidential Information belonging to the other Party to the
extent (and only to the extent) such disclosure is reasonably necessary in the following instances:


 


11.3.1
filing or prosecuting patents as set forth in this Agreement;


 


11.3.2
Licensor’s research, Development or Commercialization (including any import, manufacture, use, offer for sale, or sale)
activities, including Licensor’s regulatory filings, with respect to Licensed Compounds and/or Licensed Product, including
any Approvals or applications therefor;


 


11.3.3
prosecuting or defending litigation in relation to the Licensed Patent Rights, Licensed Property, Licensed Know How or this
Agreement, including responding to a subpoena in a Third Party litigation; provided it has used good faith and reasonable efforts
to obtain a protective order for such Confidential Information;


 


11.3.4
subject to Section 11.4, complying with applicable Laws (including the rules and regulations of the Securities and Exchange
Commission or any national securities exchange) and with judicial process, if in the reasonable opinion of the receiving Party’s
counsel, such disclosure is necessary for such compliance; provided, however, that except where impracticable, the receiving
Party shall give the disclosing Party reasonable advance notice of such disclosure requirement (which shall include a copy of
any applicable subpoena or order) and shall afford the disclosing Party a reasonable opportunity to oppose, limit or secure confidential
treatment for such required disclosure, and in the event of any such required disclosure, the receiving Party shall disclose only
that portion of the Confidential Information of the disclosing Party that the receiving Party is legally required to disclose;


 


11.3.5
disclosure, in connection with the performance of this Agreement and solely on a “need to know basis”, to Affiliates,
existing or potential collaborators (including existing or potential co-marketing and co-promotion contractors), research collaborators,
employees, consultants, or agents, each of whom prior to disclosure must be bound by written obligations of confidentiality and
non-use no less restrictive than the obligations set forth in this Article 11; provided, however, that the receiving Party
shall remain responsible for any failure by any Person who receives Confidential Information pursuant to this Article 11 to treat
such Confidential Information as required under this Article 11; and


 


11.3.6
made by such Party to existing or potential acquirers or merger candidates; investment bankers; public and private sources
of funding; existing or potential investors, venture capital firms or other financial institutions or investors for purposes of
evaluating or carrying out an acquisition, merger, or financing transaction, provided that such Party has used good faith
and reasonable efforts to secure an agreement from any such Third Party to be bound by obligations of confidentiality and restrictions
on use of Confidential Information that are no less restrictive than the obligations in this Agreement.


 






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If
and whenever any Confidential Information is disclosed in accordance with this Section 11.3, such disclosure shall not cause
any such information to cease to be Confidential Information except to the extent that such disclosure results in a public disclosure
of such information (otherwise than by breach of this Agreement). Where reasonably possible and subject to Section 11.4,
the receiving Party shall notify the disclosing Party of the receiving Party’s intent to make such disclosure pursuant to
this Section 11.3 sufficiently prior to making such disclosure so as to allow the disclosing Party adequate time to take
whatever action it may deem appropriate to protect the confidentiality of the information.


 


11.4
Terms of this Agreement. The Parties acknowledge that the terms of this Agreement shall be treated as Confidential
Information of both Parties. For the avoidance of doubt, this Section 11.4 shall in no way prevent a Party from disclosing
the existence of this Agreement or any terms of this Agreement in order to seek legal advice whenever deemed appropriate by such
Party or to enforce such Party’s rights under this Agreement, whether through arbitral proceedings, court proceedings or
otherwise, or to defend itself against allegations or claims relating to this Agreement, or to comply with Applicable Law (except
as provided in Section 11.5 below) when advised in a written opinion of outside counsel that terms of the Agreement are required
to be disclosed to comply with Applicable Law.


 


11.5
Securities Filings. Notwithstanding anything to the contrary in this Agreement, in the event either Party proposes
to file with the Securities and Exchange Commission or the securities regulators of any state or other jurisdiction a registration
statement or any other disclosure document which describes or refers to this Agreement under the Securities Act of 1933, as amended,
the Securities Exchange Act, of 1934, as amended, any other applicable securities Law or the rules of any national securities
exchange, the Party shall notify the other Party of such intention and shall use reasonable efforts to provide such other Party
with a copy of relevant portions of the proposed filing not less than ten (10) days prior to (but in no event later than four
(4) days prior to) such filing (and any revisions to such portions of the proposed filing a reasonable time prior to the filing
thereof), including any exhibits thereto relating to this Agreement, and shall use reasonable efforts to obtain confidential treatment
of any information concerning this Agreement that such other Party requests be kept confidential, and shall only disclose Confidential
Information which it is advised by counsel is legally required to be disclosed. No such notice shall be required under this Section 11.5
if the substance of the description of or reference to this Agreement contained in the proposed filing has been included in any
previous filing made by the either Party hereunder or otherwise approved by the other Party.


 


11.6
Publication by Licensor. Licensee may publish or present data and/or results relating to a Licensed Compound or Licensed
Product developed in the Field in scientific journals and/or at scientific conferences, provided that Licensee shall notify Licensor
at least ten (10) days in advance of the intended submission for publication or presentation of any proposed abstract, manuscript
or presentation which discloses Confidential Information of Licensor or discloses a patentable invention by delivering a copy
thereof to Licensor. Licensor shall have five (5) days from its receipt of any such abstract, manuscript or presentation in which
to notify Licensee in writing of any specific, reasonable objections to the disclosure, based on concern regarding the specific
disclosure of Confidential Information of Licensor, and Licensee will delete any Licensed Confidential Information, and consider
any other such objections in good faith, including whether it is necessary or advisable to delete any other information from such
proposed publication. Once any such abstract or manuscript is accepted for publication, Licensee shall provide Licensor with a
copy of the final version of the manuscript or abstract.


 






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ARTICLE
12


INDEMNITY


 


12.1
Licensee Indemnity. Licensee shall indemnify, defend and hold harmless Licensor and its Affiliates, and their respective
officers, directors, employees, agents, licensors, and their respective successors, heirs and assigns and representatives, from
and against any and all damages, liabilities, losses, costs and expenses (including reasonable legal expenses, costs of litigation
and reasonable attorney’s fees) arising in connection with any claims, suits, proceedings, whether for money damages or
equitable relief, of any kind brought by any Third Party (collectively “Losses and Claims”) and arising out
of or relating to (a) a breach of this Agreement by Licensee or any of its Affiliates, Sub-Licensees, agents and contractors,
(b) the research, Development, Commercialization (including promotion, advertising, offering for sale, sale or other disposition),
transfer, importation or exportation, manufacture, labeling, handling or storage, or use of, or exposure to, any Licensed Compound
or any Licensed Product by or for, or failure to comply with applicable Law by, Licensee or any of its Affiliates, Distributors,
SubLicensees, agents and contractors, including claims and threatened claims based on product liability, bodily injury, risk of
bodily injury, death or property damage, infringement or misappropriation of Third Party patents, copyrights, trademarks or other
intellectual property rights, or the failure to comply with applicable Law related to the matters referred to in this subsection
(a) with respect to any Licensed Compound or any Licensed Product, (c) the prosecution, maintenance, enforcement and
defense of the Licensed Property, Licensed Patents by Licensee, its Affiliates, SubLicensees, representatives and agents; and/or
(d) the gross negligence, recklessness or willful misconduct of Licensee or its Affiliates or its or their respective directors,
officers, employees and agents, in connection with Licensee’s performance of its obligations or exercise of its rights under
this Agreement; except in any such case for Losses and Claims to the extent reasonably attributable to any breach of this
Agreement by Licensee (including its representations and warranties set forth in Section 4.1 and Article 9), or Licensee
having committed an act or acts of gross negligence, recklessness or willful misconduct, or to the extent Licensor has an indemnification
obligation to Licensee pursuant to Section 12.2.


 


12.2
Licensor Indemnity. Licensor shall indemnify, defend and hold harmless Licensee and its Affiliates, and their respective
officers, directors, employees, agents, licensors, and their respective successors, heirs and assigns and representatives, from
and against any and all Losses payable to a Third Party based on Claims brought by a Third Party arising out of or relating to
(a) a breach of this Agreement by Licensor, including the representations, warranties and covenants of Licensor set forth
in Section 4.1 and/or Article 9, (b) the gross negligence, recklessness or willful misconduct of Licensor or its Affiliates
or its or their respective directors, officers, employees and agents, in connection with Licensor’s performance of its obligations
or exercise of its rights under this Agreement, (c) personal injury arising out of the conduct by Licensor of any clinical
studies for the Licensed Property prior to the Effective Date, (d) payments for services rendered to Licensor prior to the
Effective Date related to the Licensed Products, (e) the conduct and close of any existing clinical or other studies involving
the Licensed Property not assigned to Licensor under Section 3.3 after the Effective Date; and/or (f) any Development,
use, manufacture, or Commercialization of Licensed Reversion Products by Licensor following the reversion thereof to Licensor
pursuant to Section 13.4 in the Territory, including any product liability claims and intellectual property infringement
claims in the Territory or any personal injury, property damage or other damage in the Territory arising therefrom; except
in any such case for Losses and Claims to the extent reasonably attributable to any breach of this Agreement by Licensee,
its Affiliates or SubLicensees, failure of Licensee, its Affiliates or SubLicensees to comply with Applicable Law with respect
to its Development or Commercialization of the Licensed Products, or Licensee, its Affiliates or SubLicensees having committed
an act or acts of gross negligence, recklessness or willful misconduct, or to the extent Licensor has an indemnification obligation
to Licensor pursuant to Section 12.1.


 






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12.3
Indemnification Procedure. A claim to which indemnification applies under Section 12.1 shall be referred to herein
as an “Indemnification Claim”. If any Person or Persons (collectively, the “Indemnitee”)
intends to claim indemnification under this Article 12, the Indemnitee shall notify the Party subject to the indemnification obligation
(the “Indemnitor”) in writing promptly upon becoming aware of any claim that may be an Indemnification Claim
(it being understood and agreed, however, that the failure by an Indemnitee to give such notice shall not relieve Indemnitor of
its indemnification obligation under this Agreement except and only to the extent that the Indemnitor is actually prejudiced as
a result of such failure to give notice). The Indemnitor shall have the right to assume and control the defense of the Indemnification
Claim at its own expense with counsel selected by the Indemnitor and reasonably acceptable to the Indemnitee, provided, however,
that an Indemnitee shall have the right to retain its own counsel, with the fees and expenses to be paid by the Indemnitee, if
representation of such Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential
differing interests between such Indemnitee and any other party represented by such counsel in such proceedings. If the Indemnitor
does not assume the defense of the Indemnification Claim as aforesaid, the Indemnitee may defend the Indemnification Claim but
shall have no obligation to do so. The Indemnitee shall not settle or compromise the Indemnification Claim without the prior written
consent of the Indemnitor, and the Indemnitor shall not settle or compromise the Indemnification Claim in any manner which would
have an adverse effect on the Indemnitee’s interests (including any rights under this Agreement or the scope or enforceability
of the Licensed Patents Rights, Licensed Products or Licensed Know-How), without the prior written consent of the Indemnitee,
which consent, in each case, shall not be unreasonably withheld, delayed or conditioned if the settlement or compromise would
impose no financial or other obligations or burdens on the Indemnitee. The Indemnitee shall reasonably cooperate with the Indemnitor
at the Indemnitor’s expense and shall make available to the Indemnitor all pertinent information under the control of the
Indemnitee, which information shall be subject to Article 11.


 


12.4
Insurance. Licensee shall, beginning with the initiation of the first clinical trial for a Licensed Product, maintain
at all times thereafter during the term of this Agreement, and until the later of (i)  termination or expiration of this
Agreement or (ii) the date that all statutes of limitation covering claims or suits that may be brought for personal injury
based on the sale or use of a Licensed Product have expired in all states in the U.S., insurance relating to the Licensed Product
from a recognized, creditworthy insurance company, on a claims-made basis, with endorsements for contractual liability and for
clinical trial and product liability, that is comparable in type and amount to the insurance customarily maintained by Licensor
with respect to similar prescription pharmaceutical products that are marketed, distributed and sold in the Territory. Within
ten (10) days following the Effective Date, and within thirty (30) days following any material change or cancellation
in coverage, Licensee shall furnish to Licensor a certificate of insurance evidencing such coverage as of such date, and in the
case of cancellation, provide a certificate evidencing that Licensor’s replacement coverage meets the requirements in the
first sentence of this Section 12.4. The foregoing insurance requirement shall not be construed to create a limit on Licensor’s
liability hereunder.


 






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ARTICLE
13


TERM
AND TERMINATION


 


13.1
Term. This Agreement shall commence as of the Effective Date and, unless sooner terminated in accordance with the terms
hereof or by mutual written consent, shall expire on a country-by-country basis and Licensed Product-by-Licensed Product basis,
upon the expiration of the Royalty Term with respect to a given Licensed Product in the applicable country but in no event later
than fifteen (15) years after the date of this Agreement.


 


13.2
Termination by Licensor. Licensor shall have the right to terminate this Agreement, at Licensor’s sole discretion,
as follows:


 


 


 


 


13.2.1
Insolvency. To the extent permitted under applicable Laws, Licensor shall have the right to terminate this Agreement
in its entirety, at Licensor’s sole discretion, upon delivery of written notice to Licensee upon the filing by Licensee
in any court or agency pursuant to any statute or regulation of the United States or any other jurisdiction a petition in bankruptcy
or insolvency or for reorganization or similar arrangement for the benefit of creditors or for the appointment of a receiver or
trustee of Licensee or its assets, upon the proposal by Licensee of a written agreement of composition or extension of its debts,
or if Licensee is served by a Third Party (and not by Licensor) with an involuntary petition against it in any insolvency proceeding,
upon the 5th day after such service if such involuntary petition has not previously been stayed or dismissed, or upon the making
by Licensee of an assignment for the benefit of its creditors.


 


13.2.2
Breach. Licensor shall have the right to terminate this Agreement in its entirety, at Licensor’s sole discretion,
(x) as provided in Section 5.6 or (y) upon delivery of written notice to Licensee in the event of any material
breach by Licensee of this Agreement (except that this Section 13.2.2 shall not apply to any breach of Sections 5.1 or 6.1,
which are covered under Section 13.2.3), provided that such breach has not been cured within three (3) months after written
notice is given by Licensor to Licensee; provided, however, that if such breach relates to the failure to make a payment when
due, such breach must be cured within one (1) month after written notice thereof is given by Licensor. Notwithstanding the foregoing,
in the case of a bona fide dispute over whether or to what extent Licensor has breached this Agreement, this Section 13.2.2
shall not be triggered until such dispute is resolved in Licensor’s favor and Licensee fails to cure such breach within
the applicable cure period (which shall be tolled until the resolution of the dispute); provided, that Licensee shall have timely
paid any amounts that are not in dispute. Any such termination of this Agreement shall become effective at the end of the applicable
cure period, unless Licensee has cured any such breach or default prior to the expiration of such cure period.


 


13.2.3
Termination for Failure to Develop or Commercialize. Licensor shall have the right to terminate this Agreement in its
entirety in the event that Licensee fails to fulfill its obligations to execute the Development Plan in accordance with Exhibit
A-1, provided that Licensee has not cured such breach within three (3) months following written notice by Licensor which
notice shall be labeled as a “notice of material breach for failure to use Commercially Reasonable Efforts,” and identifies
the Major Market Country(ies) in which such breach has occurred. If Licensee disputes the material breach of its obligations under
Sections 5.1 and 6.1, this Section 13.2.3 shall not be triggered until such dispute is resolved in Licensor’s favor
and Licensee fails to cure such breach within any portion of the applicable cure period then remaining (which shall be tolled
until the resolution of the dispute. For clarity, if arbitration is triggered under Section 14.2 10 days after receipt of
the notice from Licensor, it shall have 30 days after an arbitrator’s decision in favor of Licensor to cure the breach).
Any such termination of this Agreement shall become effective at the end of the applicable remaining cure period, unless Licensee
has cured any such breach or default prior to the expiration of such remaining cure period.


 



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13.2.4
Termination for Patent Challenge.


 


(a)
Licensor shall have the right to terminate this Agreement in its entirety in the event Licensee (or any of its Affiliates)
challenges or knowingly supports (other than as may be necessary or reasonably required to assert a cross-claim or a counter-claim,
or in response to a subpoena or court or administrative law request or order), including by providing information, documents,
and/or funding, a challenge to the validity, scope, enforceability or patentability of any of the Licensed Property, the Licensed
Patent Rights or any of them. Licensor’s right to terminate this Agreement under this Section 13.2.4 may be exercised
at any time after Licensee (or any of its Affiliates) may have challenged or knowingly supports (other than in response to a subpoena
or court order) a challenge to the validity, scope, enforceability or patentability of any of the Licensed Property, the Licensed
Patent Rights or any of them. For the avoidance of doubt, an action by Licensee or any Affiliate in accordance with Article 10
to amend claims within a pending patent application within the Licensed Property, the Licensed Patent Rights during the course
of Licensee’s prosecution and maintenance of such pending patent application or in defense of a Third Party proceeding,
or to make a negative determination of patentability of claims of a patent application of Licensor or to abandon a patent application
of Licensor during the course of Licensee’s Prosecution and Maintenance of such pending patent application, shall not, where
undertaken in accordance with Article 9 hereof, constitute a challenge under this Section 13.2.4.


 


(b)
If a Sub-Licensee of Licensee challenges the validity, scope or enforceability of or otherwise opposes any of the Licensed
Patent Rights or Licensed Property under which such Sub-Licensee is sublicensed, then Licensor shall, at Licensor’s election
and upon written notice from Licensor, promptly terminate such Sublicense. Licensee shall include within each License Agreement
with each Sub-Licensee a right on the part of Licensor to terminate such License Agreement in the event such Sub-Licensee challenges
or knowingly supports a Third Party in challenging (other than in response to a subpoena or court order), in a judicial or administrative
proceeding, including without limitation by providing information, documents, or funding, the validity, scope or enforceability
of any of the Licensed Property or Licensed Patent Rights after grant of the patent and Licensee shall exercise such right
to terminate the License Agreement with a Sub-Licensee should such Sub-Licensee challenge or knowingly support a Third Party in
challenging (other than in response to a subpoena or court order) in a judicial or administrative proceeding the validity or enforceability
of any of the Licensed Property and Licensed Patent Rights after grant of the patent. If Licensee fails to exercise such termination
right against such Sub-Licensee or is unable to do so because it did not include such a provision in its Sublicense, Licensor
may terminate this Agreement.


 






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13.3
Termination by Licensee. Licensee shall have the right to terminate this Agreement, at Licensee’s sole discretion,
as follows:


 


13.3.1
Following completion by Licensee of the Development Plan of the Licensed Product, upon three (3) month’s prior written
notice in the case where there is a breach to this agreement, or upon thirty (30) days prior written notice in the case where
a default occurs by the Licensee.


 


13.3.2
Licensee may terminate this Agreement in the event of a material breach by Licensor, provided that such breach has not been
cured within three (3) months following written notice by Licensee to Licensor. Any such termination of this Agreement shall become
effective at the end of the applicable cure period, unless Licensor has cured any such breach or default prior to the expiration
of such cure period.







 


13.4
Effect of Termination. Upon termination of this Agreement in its entirety by Licensor under Section 13.2 or by
Licensee under Section 13.3.1:


 


13.4.1
All rights and licenses granted to Licensee in Article 2 shall terminate, all rights of Licensee under the Licensed Property
and Licensed Patent Rights and Licensed Know-How shall revert to Licensor, and Licensee and its Affiliates shall cease all use
of the Licensed Property and the Licensed Patent Rights, the Licensed Know-How and the Transferred Materials, and shall return
to Licensor all unused portions of the Transferred Materials.


 


13.4.2
With respect to all regulatory filings (including all INDs, MAAs, MAs, CTAs, CTXs and BLAs) and Approvals and all other regulatory
filings and documents necessary to further Develop and Commercialize the Licensed Reversion Products, as they exist as of the
date of such termination (and all of Licensor’s right, title and interest therein and thereto), Licensor shall determine
in its sole discretion which of these shall be (i) assigned to Licensor, and Licensee shall provide to Licensor one (1) copy
of the applicable documents and filings, all documents and filings contained in or referenced in any such filings, together with
the raw and summarized data for any preclinical and clinical studies of the Licensed Reversion Products as well as any final documentation
to inactivate any open INDs as Licensor may elect to inactivate, For clarity, Licensor shall have the right to use the foregoing
material information, materials and data developed by Licensee solely in connection with Licensed development, manufacture and
commercialization of Licensed Reversion Products. Licensor shall have the right to obtain specific performance of Licensee’s
obligations referenced in this Section 13.4.2 and/or in the event of failure to obtain assignment, Licensee hereby consents
and grants to Licensor the right to access and reference (without any further action required on the part of Licensee, whose authorization
to file this consent with any Regulatory Authority is hereby granted) any and all such regulatory filings for any regulatory or
other use or purpose in the Territory. Without limiting the foregoing in this paragraph, to the extent applicable, Licensee’s
obligations under Article 10 shall continue with respect to all countries in the Territory for which there is a failure to obtain
assignment of all regulatory filings and Approvals.


 






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13.4.3
All amounts due or payable to Licensor that were accrued prior to the effective date of termination shall remain due and payable;
but (except as otherwise expressly provided herein) no additional amounts shall be payable based on events occurring after the
effective date of termination; provided, that the foregoing shall not be deemed to limit either Party’s indemnification
obligations under this Agreement for acts or omissions incurring prior to the termination date that are the subject of such indemnification
even if the indemnification amount cannot be accrued or determined as of the termination date.


 


13.4.4
Should Licensee have any inventory of any Licensed Products included in the Licensed Reversion Products suitable for use in
clinical trials, Licensee shall immediately return such products to Licensor.


 


13.4.5
Should Licensee have any inventory of any Licensed Product included in the Licensed Reversion Products approved and allocated
prior to termination, Licensee shall have thereafter in which to dispose of such inventory (subject to the payment to Licensor)
of any royalties due hereunder thereon) (the “Inventory Disposal Period”), provided however, that (i) such
right shall terminate at such time that Licensor purchases all remaining stocks of inventory of such Licensed Reversion Product
as described in this Section 13.4.6, below, and (ii) such Licensed Product shall be provided to such purchaser for the
Licensed Product in the applicable country during the 30 day period preceding such termination.







 


13.4.6
Licensee shall provide to Licensor the tangible embodiments of all Know-How owned or Controlled by Licensee and its Affiliates
to the extent necessary for the Development and Commercialization of the Licensed Reversion Products in existence as of the date
of such termination, including Licensee’s manufacturing processes, techniques and trade secrets for making such Licensed
Reversion Products and all Know-How specifically relating to any composition, formulation, method of use or manufacture of such
Licensed Reversion Products, Licensor shall receive the aforementioned with all ownership rights. Licensee shall reasonably cooperate
with Licensor to assist Licensor with understanding and using the Know-How provided to Licensor under this Section 13.4.7.
Such cooperation shall include providing Licensor with reasonable access by teleconference or in-person at Licensee’s facilities
(subject to Licensee’s customary rules and restrictions with respect to site visits by non-Licensee personnel.


 


13.4.7
To the extent that Licensee owns any trademark(s), USAN names, and/or domain names that are used in connection with a Licensed
Reversion Product that Licensor believes would be necessary for the Commercialization of a Licensed Reversion Product (as then
currently marketed, but not including any marks that include, in whole or part, any corporate name or logo of Licensee), Licensee
shall assign (or, if applicable, cause its Affiliate to assign) to Licensor all of Licensee’s (and such Affiliate’s)
right, title and interest in and to any such trademark, USAN name or internet domain name in each terminated country.


 






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13.4.8
Licensee shall grant and hereby grants to Licensor an exclusive, royalty-bearing, non-transferable (except as provided in
Section 15.4) license, with the right to grant sublicenses, under (a)(i) any Patent Rights owned or Controlled by Licensee
or its Affiliates as at the effective date of termination (other than Patent Rights Controlled by Licensor and its Affiliates
that were licensed to Licensee under this Agreement) and (ii) all Patent Rights owned or Controlled by Licensee or its Affiliates
after the date of such termination claiming any invention conceived or reduced to practice by or on behalf of Licensee during
the term of this Agreement and (b) any Trademarks and USAN names owned by Licensee that are used in connection with the Licensed
Product, in each case (a)(i) and (ii) that are not Patent Rights licensed from Licensor and only to the extent such Patent
Rights cover the composition of matter, use, or manufacture of Licensed Reversion Products (solely to the extent actually practiced
in connection with the Licensed Reversion Products as of such termination effective date) and that, in each case of (a) and
(b), are necessary to develop, manufacture or commercialize Licensed Reversion Products.


 


13.4.9
Licensee shall provide to Licensor all data generated during the term of this Agreement necessary for the development and/or
commercialization of the relevant Licensed Reversion Products.


 


13.4.10
Neither Party shall be relieved of any obligation that accrued prior to the effective date of such termination.


 


13.4.11
Licensor shall not owe any other compensation to Licensee for the research, Development and Commercialization of any Licensed
Reversion Product in the event of any such termination of the Agreement by Licensor, except as expressly set forth in Section 13.4.8.


 


13.4.12
Any costs and expenses incurred by Licensee in connection with the assignments and transfers made by Licensee under this Section 13.4
shall be born by the Licensee, in which case any such costs and expenses reasonably incurred by Licensee shall be Licensee’s
sole responsibility.


 


13.4.13
It is understood and agreed that Licensor shall be entitled to specific performance as a remedy to enforce the provisions
of this Section 13.4, in addition to any other remedy to which it may be entitled by applicable Law.


 


13.4.14
If Licensee is using Third Parties to manufacture and supply Licensed Product to it at the time of termination, Licensee will,
at Licensor’s request, reasonably cooperate with Licensor to assign such Third Party agreements to Licensor at Licensor’s
request. If Licensee is manufacturing any portion of the Licensed Product for itself, and has the capability in place as of the
date of such termination to commercially manufacture and supply to Licensor all or part of Licensor’s requirements of the
applicable Licensed Reversion Products for use and sale in the Territory, if Licensor so elects in its sole discretion, Licensee
shall supply to Licensor for a period not to exceed one (1) year (with the period of time being within the sole discretion
of Licensor) as much of Licensor’s requirements of such Licensed Reversion Products as reasonably possible for use and sale
in the Territory, for such Licensed Reversion Products. In the event that Licensee has, prior to the date of such termination,
engaged a Third Party to manufacture and supply any Licensed Reversion Products, Licensee shall use reasonable efforts, at Licensee’s
sole cost and expense, to assist in the transfer of such supply arrangements to Licensor, or if not assigned or assignable, then
Licensee shall supply such Licensed Reversion Products associated with providing such Licensed Reversion Products to Licensor.


 






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13.4.15
Nothing in this Section 13.4 shall be deemed to limit any remedy to which either Party may be entitled by applicable
Law.


 


13.5
Effect of Termination by Licensor for Breach by Licensee. Upon termination of this Agreement by Licensor pursuant to
Section 13.3.2:


 


 


13.5.1
All rights and licenses granted to Licensee in Article 2 shall terminate, all rights of Licensee under the Licensed Property
and Licensed Patent Rights and Licensed Know-How shall revert to Licensor, and Licensee and its Affiliates shall cease all use
of the Licensed Property and Licensed Patent Rights, the Licensed Know-How and the Transferred Materials, and shall return to
Licensor all unused portions of the Transferred Materials.


 


13.5.2
All amounts due or payable to Licensor that were accrued, or that arise out of acts or events occurring, prior to the effective
date of termination or expiration shall remain due and payable; but (except as otherwise expressly provided herein) no additional
amounts shall be payable based on events occurring after the effective date of termination or expiration.


 


13.5.3
Should Licensee have any inventory of any Licensed Product approved and allocated prior to termination for sale in a terminated
country, Licensee shall have thirty (30) days thereafter in which to dispose of such inventory (subject to the payment to Licensor
of any royalties due hereunder thereon).


 


13.5.4
Neither Party shall be relieved of any obligation that accrued prior to the effective date of such termination or expiration.


 


13.5.5
Nothing in this Section 13.5 shall be deemed to limit any remedy to which Licensee may be entitled by applicable Law.


 


13.6
Effect of Expiration of this Agreement. Upon expiration of this Agreement:


 


13.6.1
All amounts due or payable to Licensor that were accrued, or that arise out of acts or events occurring, prior to the effective
date of expiration shall remain due and payable; but (except as otherwise expressly provided herein) no additional amounts shall
be payable based on events occurring after the effective date of expiration.


 


13.6.2
Licensor shall have the right to retain all amounts previously paid to Licensor by Licensee.


 


13.6.3
Neither Party shall be relieved of any obligation that accrued prior to the effective date of expiration.


 


13.6.4
The license with respect to Licensed Property, Licensed Patent Rights and Licensed Know-How granted under Section 2.1
shall remain in effect and shall be fully paid-up.


 






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13.7
Scope of Termination. Termination of this Agreement shall be as to all countries in the Territory and all Licensed
Property, Licensed Patent Rights and Licensed Know-How granted under Section 2.1.





 


13.8
Survival. The following provisions shall survive termination or expiration of this Agreement, as well as any other
provisions which by their nature are intended to survive termination: Article 1 (as applicable), Sections 8.7 (for five (5) years
after the end of the Calendar Year in which this Agreement was terminated), Section 9.4, Section 9.5, Section 10.1,
Section 10.4 (with respect to an action, suit or proceeding commenced prior to termination), Section 10.8, Article 11,
Article 12, Section 13.4 (if terminated by LICENSEE under Section 13.2 or by Licensor under Section 13.3.1, Section 13.5
(if terminated by Licensor pursuant to Section 13.3.2), Section 13.6, Section 13.7, this Section 13.8, Section 13.10,
Article 14 and Article 15.


 


13.9
Bankruptcy. The Parties agree that in the event a Party becomes a debtor under Title 11 of the U.S. Code (“Title
11”), this Agreement shall be deemed to be, for purposes of Section 365(n) of Title 11, a license to rights to
“intellectual property” as defined therein. Each Party as a Licensee hereunder shall have the rights and elections
as specified in Title 11. Any agreements supplemental hereto shall be deemed to be “agreements supplementary to” this
Agreement for purposes of Section 365(n) of Title 11.


 


13.10
No Limitation of Remedies. Except as herein expressly provided, notwithstanding anything to the contrary in this Agreement,
except as otherwise set forth in this Agreement, termination or expiration of this Agreement shall not relieve the Parties of
any liability or obligation which accrued hereunder prior to the effective date of such termination or expiration nor prejudice
either Party’s right to obtain performance of any obligation. Each Party shall be free, pursuant to Article 14, to seek
(without restriction as to the number of times it may seek) damages, costs and remedies that may be available under applicable
Law or in equity and shall be entitled to offset the amount of any damages and costs obtained in a final determination under Article
14 of monetary damages or costs (as permitted by this Agreement) against the other Party against any amounts otherwise due to
such other Party under this Agreement.


 


ARTICLE
14


DISPUTE
RESOLUTION


 


14.1
Resolution by Senior Executives. Except as provided in Sections 8.7 and 14.3, in the event of any dispute between the
Parties in connection with this Agreement, the construction hereof, or the rights, duties or liabilities of either Party hereunder,
including any disagreement as to whether there has been a material breach of this Agreement pursuant to Sections 13.2.2, 13.2.3,
or 13.3.2, the Parties shall first attempt in good faith to resolve such dispute by negotiation and consultation between themselves.
In the event that such dispute is not resolved on an informal basis within sixty (60) days, either Party may, by written notice
to the other Party, refer the dispute to the American Arbitration Association in San Diego, California for attempted resolution
by good faith negotiation within fifteen (15) days after such notice is received; provided, however, such executive officers of
Licensee and Licensor may each designate a senior manager to whom such dispute is delegated instead for such attempted resolution.


 






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14.2
Arbitration.


 


14.2.1
Except as provided in Sections 8.7 and 14.3, if any dispute between the Parties relating to or arising out this Agreement
cannot be resolved in accordance with Section 14.1, any dispute or claim arising to or in any way related to this Agreement
shall be settled by binding arbitration in San Diego, California but any dispute or controversy arising out of or interpreting
this Agreement shall be settled in accordance with the laws of the State of California as if this Agreement were executed and
all actions were performed hereunder within the State of California. All arbitration shall be conducted in accordance with the
rules and regulations of the American Arbitration Association ("AAA"). AAA shall designate an arbitrator from an approved
list of arbitrators following both parties' review and deletion of those arbitrators on the approved list having a conflict of
interest with either party. Each party shall pay its own expenses associated with such arbitration. A demand for arbitration shall
be made within a reasonable time after the claim, dispute or other matter has arisen and in no event shall such demand be made
after the date when institution of legal or equitable proceedings based on such claim, dispute or other matter in question would
be barred by the applicable statutes of limitations. The decision of the arbitrators shall be rendered within 60 days of submission
of any claim or dispute, shall be in writing and mailed to all the parties included in the arbitration. The decision of the arbitrator
shall be binding upon the parties and judgment in accordance with that decision may be entered in any court having jurisdiction
thereof.


 


14.2.2
The arbitration shall be conducted by a panel of three (3) persons experienced in the pharmaceutical business: within
twenty (20) days after initiation of arbitration, each Party shall select one person to act as arbitrator and the two Party-selected
arbitrators shall select a third arbitrator within five (5) days of their appointment. All proceedings and communications shall
be in English.


 


14.2.3
The arbitrators shall apply the terms and conditions of this Agreement and shall not award damages in contradiction to Section 9.5.
Each Party shall bear its own costs and expenses and attorneys’ fees and an equal share of the arbitrators’ fees and
any administrative fees of arbitration regardless of the outcome of such arbitration.


 


14.2.4
Except to the extent necessary to confirm an award or as may be required by law, neither a Party nor an arbitrator may disclose
the existence, content or results of an arbitration without the prior written consent of both Parties The arbitrators shall have
no authority to award any relief on the basis of any dispute, controversy or claim that is barred by the applicable California
statute of limitations.


 


14.3
Injunctive Relief. Notwithstanding anything in this Article 14, each Party shall have the right to seek injunctive
or other equitable relief from the arbitrator or a court of competent jurisdiction pursuant to Section 15.8 that may be necessary
to avoid irreparable harm, maintain the status quo or preserve the subject matter of the dispute, including any breach or threatened
breach of Article 11. 


 






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ARTICLE
15


MISCELLANEOUS


 


15.1
Severability. If any one or more of the provisions of this Agreement is held to be invalid or unenforceable, the provision
shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof. The Parties
shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the
objectives contemplated by the Parties when entering this Agreement with respect to such provision may be realized.


 


15.2
Notices. Any notice required or permitted to be given by this Agreement shall be in writing and shall be delivered
by hand or overnight courier with tracking capabilities or mailed postage prepaid by first class, registered or certified mail,
return receipt requested and addressed as set forth below unless changed by notice so given:


 


If
to Licensor:


Regen
BioPharma, Inc.


4700
Spring Street, Suite 304


La
Mesa, California 91942


U.S.A.


Attn:
Dr. David R. Koos, CEO


Facsimile:
619.330.2328


 


If
to Licensee:


CheckPoint
Immunology, Inc. 


4700
Spring Street, Suite 304


La
Mesa, California 91942


U.S.A.


Attn:
Dr. David R. Koos, CEO


Facsimile:
619.330.2328


 


Any
such notice shall be deemed delivered on the date received. A Party may add, delete, or change the person or address to whom notices
should be sent at any time upon written notice delivered to the Party’s notices in accordance with this Section 15.2.


 


15.3
Force Majeure. Neither Party shall be liable for delay or failure in the performance of any of its obligations hereunder
if such delay or failure is due to causes beyond its reasonable control, including acts of God, fires, earthquakes, strikes and
labor disputes, acts of war, terrorism, civil unrest or intervention of any governmental authority (“Force Majeure”);
provided, however, that the affected Party promptly notifies the other Party and further provided that the affected Party
shall use Commercially Reasonable Efforts to avoid or remove such causes of non-performance and to mitigate the effect of such
occurrence, and shall continue performance with the utmost dispatch whenever such causes are removed. When such circumstances
arise, the Parties shall negotiate in good faith any modifications of the terms of this Agreement that may be necessary or appropriate
in order to arrive at an equitable solution.


 






    	 	43	 



     


    

 


15.4
Assignment.


 


15.4.1
Licensor may, without Licensee’s consent, (x) assign, delegate or transfer some or all of its rights and obligations
hereunder to any Affiliate of Licensor, and (y) assign or transfer, in connection with any transfer or assignment of all
of the Licensed Property, Licensed Patent Rights and Licensed Know-How, to any Third Party (including a successor in interest
by reason of merger, consolidation or sale of substantially all of the assets of Licensor to which this Agreement relates).


 


15.4.2
Licensee may assign or transfer all of its rights and obligations hereunder without Licensor’s consent to a successor
in interest by reason of merger, consolidation or sale of substantially all of the assets of Licensor (and so long as such assignment
or transfer includes, without limitation, all Approvals, all manufacturing assets relating to this Agreement, and all rights and
obligations under this Agreement); provided, however, that such successor in interest shall have agreed no later than the
closing of such assignment or transfer transaction to be bound by the terms of this Agreement in a writing provided to Licensor.


 


15.4.3
Subject to the foregoing, this Agreement shall inure to the benefit of, and be binding on, the Parties’ permitted successors
and assigns. Any assignment or transfer in violation of the foregoing shall be null and void and wholly invalid, the assignee
or transferee in any such assignment or transfer shall acquire no rights whatsoever, and the non-assigning non-transferring Party
shall not recognize, nor shall it be required to recognize, such assignment or transfer.


 


15.4.4
In the event that Licensor assigns, delegates or otherwise transfers this Agreement in whole or in part, to an Affiliate of
the Licensor, Licensee hereby agrees to be jointly and severally liable with any such Affiliates for the actions of such Affiliates
and for any and all amounts that become due and payable hereunder to Licensor. In the event that Licensee assigns or otherwise
transfers or assigns this Agreement to an Affiliate of Licensee, Licensee hereby agrees to be jointly and severally liable with
any such Affiliates for the actions of such Affiliates and for any and all amounts that become due and payable hereunder to Licensor.


 


15.4.5
Notwithstanding anything to the contrary in this Agreement, in the event of any such transfer or assignment to a Third Party
(including a successor in interest by reason of merger, consolidation or sale of assets permitted), the intellectual property
rights of the acquiring party (if other than one of the Parties) or the acquired party (if acquired by a Party or its Affiliates)
shall not be included in the technology licensed to the other Party hereunder to the extent (x) held by such Third Party
that is acquired or is acquiring such Party prior to such transaction, or (y) such technology is developed thereafter outside
the scope of activities conducted with respect to the Licensed Property. Licensed Patent Rights, or Licensed Products.


 






    	 	44	 



     


    

 


15.5
Further Assurances. Each Party agrees to do and perform all such further acts and things and shall execute and deliver
such other agreements, certificates, instruments and documents necessary or that the other Party may deem advisable in order to
carry out the intent and accomplish the purposes of this Agreement and to evidence, perfect or otherwise confirm its rights hereunder.


 


15.6
Waivers and Modifications. The failure of any Party to insist on the performance of any obligation hereunder shall
not be deemed to be a waiver of such obligation. Waiver of any breach of any provision hereof shall not be deemed to be a waiver
of any other breach of such provision or any other provision on such occasion or any succeeding occasion. No waiver, modification,
release or amendment of any obligation under or provision of this Agreement shall be valid or effective unless in writing and
signed by each of the Parties.


 


15.7
Choice of Law. This Agreement shall be governed by, enforced, and shall be construed in accordance with the laws of
the Nevada without regard to its conflicts of law provisions.


 


15.8
Publicity. Upon execution of this Agreement, Licensor may issue the press release announcing the existence of this
Agreement in the form and substance as set forth in Appendix 5. Each Party agrees not to issue any other press release
or other public statement disclosing other information relating to this Agreement or the transactions contemplated hereby without
the prior written consent of the other Party, such consent not to be unreasonably withheld, delayed or conditioned, provided,
however, that such consent shall not be required for any disclosure which is required by Law or the rules of a securities
exchange, as reasonably advised by the disclosing Party’s outside counsel, and provided, further, that Licensor may
from time to time issue public statements relating to the ongoing Development and/or Commercialization of Licensed Compounds and/or
Licensed Products (excluding disclosure of the financial terms of this Agreement) pursuant to this Agreement without the prior
written consent of Licensor. The Parties agree that any such required disclosure shall not contain confidential business or technical
information and, if disclosure of confidential business or technical information is required by Law, the Parties shall use appropriate
diligent efforts to minimize such disclosure and obtain confidential treatment for any such information which is disclosed to
a governmental agency. Each Party agrees to provide to the other Party a copy of any public announcement regarding this Agreement
or the subject matter thereof as soon as reasonably practicable under the circumstances prior to its scheduled release. Except
under extraordinary circumstances, each Party shall provide the other with an advance copy of any such announcement at least ten
(10) business days prior to its scheduled release. Each Party shall have the right to expeditiously review and recommend changes
to any such announcement and, except as otherwise required by Law, the Party whose announcement has been reviewed shall remove
any information the reviewing Party reasonably deems to be inappropriate for disclosure. The contents of any announcement or similar
publicity which has been reviewed and approved by the reviewing Party can be re-released by either Party without a requirement
for re-approval.


 


15.10
Relationship of the Parties. At the date of execution of this agreement, Licensee is a wholly owned subsidiary of Licensor.


 






    	 	45	 



     


    

 


15.11
Headings & Incorporation by Reference. Headings and captions are for convenience only and are not be used in the
interpretation of this Agreement. Exhibits A, A-1, B, C, and D are an integral part of this Agreement and each is incorporated
by reference herein.


 


15.12
Entire Agreement. This Agreement constitutes the entire agreement between the Parties as to the subject matter of this
Agreement, and supersedes and merges all prior negotiations, representations, agreements and understandings regarding the same.


 


15.13
Counterparts; Electronic Delivery. This Agreement may be executed in counter-parts with the same effect as if both
Parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall
constitute one and the same instrument. Signatures to this Agreement transmitted by email in “portable document format”
(“.pdf”), or by any other electronic means intended to preserve the original graphic and pictorial appearance of this
Agreement shall have the same effect as physical delivery of the paper document bearing original signature.


 


15.14
Performance by Affiliates. Each Party recognizes that the other Party may perform some or all of its obligations under
this Agreement through Affiliates to the extent permitted under this Agreement; provided, however, that such other Party
shall remain responsible for the performance by its Affiliates as if such obligations were performed by such other Party.


 


15.15
Exports. Licensee agrees not to export or re-export, directly or indirectly, any information, technical data, the direct
product of such data, samples or equipment received or generated under this Agreement in violation of any applicable export control
Laws.


 


15.16
Interpretation.


 


15.16.1
Each of the Parties acknowledges and agrees that this Agreement has been diligently reviewed by and negotiated by and between
them, that in such negotiations each of them has been represented by competent counsel and that the final agreement contained
herein, including the language whereby it has been expressed, represents the joint efforts of the Parties and their counsel. Accordingly,
in interpreting this Agreement or any provision hereof, no presumption shall apply against any Party as being responsible for
the wording or drafting of this Agreement or any such provision, and ambiguities, if any, in this Agreement shall not be construed
against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.


 


15.16.2
The definitions of the terms herein shall apply equally to the singular and plural forms of the terms defined. Whenever the
context may require, any pronoun shall include the corresponding masculine, feminine and neuter forms. The words “include”,
“includes” and “including” shall be deemed to be followed by the phrase “without limitation”.
The word “will” shall be construed to have the same meaning and effect as the word “shall”. The word “any”
shall mean “any and all” unless otherwise clearly indicated by context.


 


15.16.3
Unless the context requires otherwise, (a) any definition of or reference to any agreement, instrument or other document
herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented
or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein),
(b) any reference to any Laws herein shall be construed as referring to such Laws as from time to time enacted, repealed
or amended, (c) any reference herein to any Person shall be construed to include the Person’s successors and assigns,
(d) the words “herein”, “hereof” and “hereunder”, and words of similar import, shall
be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (e) all references herein
to Articles, Sections or Appendices, unless otherwise specifically provided, shall be construed to refer to Articles, Sections
and Appendices of this Agreement; and (f) the term “and/or” in a sentence shall be construed such that the phrase
“X and/or Y” means “X or Y, or both X and Y”.


 






    	 	46	 



     


    

 


15.16.4
This Agreement should be interpreted in its entirety and the fact that certain provisions of this Agreement may be cross-referenced
in a Section shall not be deemed or construed to limit the application of other provisions of this Agreement to such Section and
vice versa.


 


IN
WITNESS WHEREOF, the Parties have caused this License Agreement to be executed by their respective duly authorized officers.


 


	 	 	 
	LICENSOR:

        (REGEN
        BIOPHARMA, INC.)

	 	 
	By:	 	/s/David
                                       R. Koos

	 	 	 
	Name:	 	David
    R. Koos
	Title:	 	Chairman
    and CEO
	 
	Date:
    2/7/2017
	 
	LICENSEE:

        (CHECKPOINT
        IMMUNOLOGY, INC.)

	 	 
	By:	 	/s/Harry
                                       Lander

	 	 	 
	Name:	 	Harry
    Lander
	Title:	 	President
    and CSO
	 
	Date:
       2/7/2017
	 	 	 
	By:	 	/s/
    Todd S Caven
	 	 	 
	Name:	 	Todd
    S. Caen
	Title:	 	Chief
    Financial Officer
	 	 	 
	Date:	 	2/7/2017



 


 


 



    	 	47	 



     


    




[Signature
Page to License Agreement]


 


[The
remainder of this page has been left intentionally blank.]


 


 


 


 


 


 


 


 


 




    	 	48	 



     


    

  


 


EXHIBIT
A


(Two
Pages)


 


 


United
States Patent # 9091696B2


“MODULATION
OF NR2F6 AND METHODS


AND
USES THEREOF”


 


United
States Provisional Patent Application # i62/363588 “Small Molecule Modulators of NR2F6 Activity”


 


2223-224
Regen BioPharma Modulation of NR2F6 and methods of use...

13/652,395 Utility 10/15/2012 11/16/2009

Regen-ImmnoThrptcsNP1 Regen BioPharma NR2F6 SILENCED
AUTOLOGOUS

IMMUNOTHERAPEUTICS 15299400 Utility 10/20/2016 10/20/2015

Regen-ImmnoThrptcsPR1 Regen BioPharma NR2F6 Silenced
Autologous

Immunotherapeutics 62243792 Utility (Provisional) 10/20/2015
10/20/2015

Regen-NR2F6ChimericNP1 Regen BioPharma NR2F6 Inhibited
Chimeric Antigen

Receptor Cells 15351414 Utility 11/14/2016 11/12/2015

Regen-NR2F6ChimericPR1 Regen BioPharma NR2F6 Inhibited
Chimeric Antigen

Receptor Cells 62254330 Utility (Provisional) 11/12/2015
11/12/2015

Regen-Personalized-PR1 Regen BioPharma Personalized
T Cell Immunotherapy

Utilizing NR2F6 Gene Silencing 62276619 Utility (Provisional)
01/08/2016

> 01/08/2016

Regen-SmallMoleculeNP1 Regen BioPharma SMALL MOLECULE
MODULATORS OF NR2F6

ACTIVITY 15364111 11/29/2016 11/29/2015

Regen-SmallMoleculePR1 Regen BioPharma Small Molecule
Modulators of NR2F6

Activity 62260617 Utility (Provisional) 11/29/2015 11/29/2015

Regen-UDCI-PR1 Regen BioPharma Universal Donor Checkpoint
Inhibitor

Silenced/Gene Edited Cord Blood Killer Cells 62327245
Utility (Provisional)

04/25/2016 04/25/2016

RegenBioPharma-CIP2 Regen BioPharma Methods and Compositions
for treatment

of cancer by inhibition of NR2F6 14/571,262 Utility
12/15/2014 11/14/2008

RegenBioPharma-CIP3 Regen BioPharma Treatment of Myelodysplastic
Syndrome

by Inhibition of NR2F6 14/572,574 Utility 12/16/2014
11/14/2008

RegenBioPharma-CIP4 Regen BioPharma Treatment of Myelodysplastic
Syndrome

by Inhibition of NR2F2 14/588,374 Utility 12/31/2014
11/14/2008

RegenBioPharma-CIP5 Regen BioPharma Methods and Compositions
for treatment

of cancer by inhibition of NR2F2 14/588,373 Utility
12/31/2014 11/14/2008

RegenBioPharma-CIP6 Regen BioPharma Modulation of Hematopoietic
Stem Cell

Differentiation 14/595,078 Utility 01/12/2015 11/14/2008
 






    	 	49	 



     


    

 


RegenBioPharma-CIP7
Regen BioPharma METHODS OF SCREENING COMPOUNDS THAT CAN

MODULATE NR2F6 BY DISPLACEMENT OF A REFERENCE LIGAND 14852623 Utility

> 09/13/2015 11/14/2008


RegenIL-17-PR1
Regen BioPharma Methods and Means of Generating IL-17

Associated Antitumor Effector Cells by Inhibition of NR2F6 Inhibition

62294007 Utility (Provisional) 02/11/2016 02/11/2016

RegenIL-18-PR1 Regen BioPharma Modulation of IL-18 Production through

Modification of NR2F6 Activity 62293828 Utility (Provisional) 02/11/2016

> 02/11/2016

RN11917593 Regen BioPharma METHOD OF CANCER TREATMENT USING SIRNA SILENCING

11/917,593 Utility 06/15/2006 06/15/2005





[The
remainder of this page has been left intentionally blank.]





 


 


  


 


 


 






    	 	50	 



     


    

 


EXHIBIT
A-1


 


INITIAL
DEVELOPMENT PLAN


 


 


	Milestone
    Event	Milestone
    Date
	Begin
    medicinal chemistry program to optimize inhibitors and activators	1Q2017
	Complete
    med chem	4Q2017
	Complete
    all IND-enabling experiments for autoimmunity and cancer (1 indication each) and submit 2 INDs	3Q2018
	Begin
    Phase 1 Trials for each indication	2Q2019
	Complete
    Phase 1 Trials	2Q2020
	Begin
    Phase 2 Trials for each indication	4Q2020


 


 


 


 


 


 


 


 


 


 






    	 	51	 



     


    

 





EXHIBIT
B


 


LICENSED
APPLICATIONS (USE)


 


For
use in humans only


 


 


 


DEVELOPMENT
BASED MILESTONE PAYMENTS


 


DEVELOPMENT






	Milestone
    Event	Milestone
    Date
	Begin
    medicinal chemistry program to optimize inhibitors and activators	1Q2017
	Complete
    med chem	4Q2017
	Complete
    all IND-enabling experiments for autoimmunity and cancer (1 indication each) and submit 2 INDs	3Q2018
	Begin
    Phase 1 Trials for each indication	2Q2019
	Complete
    Phase 1 Trials	2Q2020
	Begin
    Phase 2 Trials for each indication	4Q2020


 


Milestone
payments will be mutually agreed upon with an outside funding source prior to being stipulated. 


ROYALTY
PAYMENTS


 


A
tiered royalty rate starting at 8% will be charged on Net Sales for the calculation period. The tiers indicating the royalty rate
are set out in the table below:


 


 


 


	 	Royalty
    rate 
	$1-$500,000,000	8%
    
	$500,000,001
    to $1,000,000,000	10%
    
	$1,000,000,001
    and greater 	12%
    


 






    	 	52	 



     


    

 


SUBLICENSE
REVENUE SHARING


  


 


Sublicense
Revenue Sharing will be mutually agreed upon with an outside funding source


  


 


 


SALES-BASED
MILESTONES..


 





 


will
be mutually agreed upon with an outside funding source


 


 


 


 


 


 


 


 


 


 



    	 	53	 



     


    




  








EXHIBIT
C


 


Exceptions
to Representations, Warranties, and Covenants of Licensor


 


 


None.


 


 


 


 


 


 


 


 


 






    	 	54	 



     


    

 





EXHIBIT
D


 


PERSONS
WITH “KNOWLEDGE” PURSUANT TO SECTION 1.3


 






	No.	Name of Person
	1.	Various scientific consultants and employees
	2.	 
	3.	 
	4.	 
	5.	 






 


 


 






    	 	55