Document:

CONFIDENTIAL
TREATMENT REQUESTED: Certain portions of this document have been omitted pursuant to a request for confidential treatment and,
where applicable, have been marked with an asterisk (“[*****]”) to denote where omissions have been made. The confidential
material has been filed separately with the Securities and Exchange Commission.

 

	 

        LICENSE
        AGREEMENT

         

        by
        and between

         

        VACTECH
        OY

         

        and

         

        PROVENTION
        BIO, INC.

        

 

 

 

	

        April
        25, 2017

         

 

    	 	 	 

     

    

 

TABLE
OF CONTENTS

 

	 	PAGES
	 	 
	Article
    1. DEFINITIONS	1
	 	 	 
	Article
    2. LICENSE GRANT	14
	 	 	 
	2.1	License
    Grant	14
	 	 	 
	2.2	Sublicensing	14
	 	 	 
	2.3	Transition
    Services and Consulting	14
	 	 	 
	2.4	Non-Compete	16
	 	 	 
	Article
    3. DEVELOPMENT, MANUFACTURING AND COMMERCIALIZATION	17
	 	 	 
	3.1	Responsibility	17
	 	 	 
	3.2	Diligence	17
	 	 	 
	3.3	Records	17
	 	 	 
	3.4	Reports	17
	 	 	 
	3.5	Compliance
    with Applicable Laws	17
	 	 	 
	Article
    4. PAYMENTS	18
	 	 	 
	4.1	Upfront
    Equity Issuance	18
	 	 	 
	4.2	Milestone
    Payments	18
	 	 	 
	4.3	Royalties	20
	 	 	 
	4.4	Royalty
    Term	20
	 	 	 
	4.5	Third
    Party Licenses	21
	 	 	 
	4.6	Compulsory
    Licenses	21
	 	 	 
	4.7	Adjustment
    for Generic Competition	21
	 	 	 
	4.8	Provention
    Board of Directors Observer Rights	21
	 	 	 
	Article
    5. PAYMENT; RECORDS; AUDITS	22
	 	 	 
	5.1	Payment;
    Reports	22
	 	 	 
	5.2	Exchange
    Rate; Manner and Place of Payment	22
	 	 	 
	5.3	Income
    Tax Withholding	22
	 	 	 
	5.4	Audits	23

 

    	 	-i-	 

     

    

 

CONFIDENTIAL

 

	Article
    6. CONFIDENTIALITY AND PUBLICATION	24
	 	 	 
	6.1	Confidential
    Information	24
	 	 	 
	6.2	Exceptions	24
	 	 	 
	6.3	Authorized
    Disclosure	24
	 	 	 
	6.4	Publications	25
	 	 	 
	6.5	Publicity	26
	 	 	 
	6.6	Prior
    Confidential Disclosure Agreement	27
	 	 	 
	6.7	Notifications	27
	 	 	 
	Article
    7. REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS	27
	 	 	 
	7.1	Mutual
    Representations and Warranties	27
	 	 	 
	7.2	Vactech
    Representations and Warranties	27
	 	 	 
	7.3	Vactech
    Covenants	29
	 	 	 
	7.4	Provention
    Representations and Warranties	30
	 	 	 
	7.5	Mutual
    Covenants	30
	 	 	 
	7.6	Performance
    by Affiliates, Sublicensees and Subcontractors	30
	 	 	 
	7.7	Limitation
    of Liability	31
	 	 	 
	Article
    8. INTELLECTUAL PROPERTY	31
	 	 	 
	8.1	Ownership	31
	 	 	 
	8.2	Patent
    Prosecution and Maintenance	31
	 	 	 
	8.3	Interference,
    Opposition, Invalidation, Reexamination and Reissue	33
	 	 	 
	8.4	Enforcement
    and Defense of Patent Rights	35
	 	 	 
	8.5	Patent
    Term Extensions	37
	 	 	 
	8.6	Infringement
    of Third Party Rights	38
	 	 	 
	Article
    9. TERM AND TERMINATION	38
	 	 	 
	9.1	Term	38
	 	 	 
	9.2	Termination
    for Material Breach	38
	 	 	 
	9.3	Termination
    for Patent Challenge	39
	 	 	 
	9.4	At-Will
    Termination by Provention	39
	 	 	 
	9.5	Effect
    of Expiration or Termination	39
	 	 	 
	9.6	Accrued
    Obligations; Survival	40
	 	 	 
	9.7	Return
    of Confidential Information	41
	 	 	 
	9.8	Damages;
    Relief	41

 

    	 	-ii-	 

     

    

 

CONFIDENTIAL

 

	Article
    10. INDEMNIFICATION	41
	 	 	 
	10.1	Indemnification
    by Provention	41
	 	 	 
	10.2	Indemnification
    by Vactech	41
	 	 	 
	10.3	Control
    of Defense	42
	 	 	 
	10.4	Insurance	42
	 	 	 
	Article
    11. DISPUTE RESOLUTION	43
	 	 	 
	11.1	Disputes	43
	 	 	 
	11.2	Arbitration	43
	 	 	 
	11.3	Court
    Actions	44
	 	 	 
	Article
    12. MISCELLANEOUS	44
	 	 	 
	12.1	Rights
    Upon Bankruptcy	44
	 	 	 
	12.2	Governing
    Law	45
	 	 	 
	12.3	Entire
    Agreement; Amendments	45
	 	 	 
	12.4	Non-Waiver	45
	 	 	 
	12.5	Assignment	45
	 	 	 
	12.6	Force
    Majeure	46
	 	 	 
	12.7	Severability	46
	 	 	 
	12.8	Notices	46
	 	 	 
	12.9	Interpretation	47
	 	 	 
	12.10	Relationship
    between the Parties	48
	 	 	 
	12.11	Cumulative
    Remedies	48
	 	 	 
	12.12	No
    Third Party Rights	48
	 	 	 
	12.13	Further
    Assurances	48
	 	 	 
	12.14	Compliance
    with Securities Laws	48
	 	 	 
	12.15	Costs	48
	 	 	 
	12.16	Counterparts	48

 

    	 	-iii-	 

     

    

 

LICENSE
AGREEMENT

 

This
License Agreement (“Agreement”),
effective as of April 25, 2017 (the “Effective Date”), is made by and between Vactech
oy, a corporation organized and existing under the laws of Finland (“Vactech”), and Provention
Bio, inc., a corporation organized and existing under the laws of the State of Delaware (“Provention”).

 

Recitals

 

Whereas,
Vactech owns or otherwise controls patents,
patent applications, know-how and other information related to a Group B coxsackie virus vaccine platform technology having potential
applications, to, among other things, the prevention of type 1 diabetes, celiac disease and the morbidity/mortality associated
with certain acute infections;

 

Whereas,
Provention has been formed to engage in the discovery, development, marketing and sale of pharmaceutical products;

 

Whereas,
Provention contemplates entering into a license agreement with respect to certain clinical stage assets with Janssen Pharmaceuticals,
Inc. (“Janssen”); and

 

Whereas,
Provention desires to obtain, and Vactech is willing to grant to Provention, a license under the Vactech Technology to discover,
develop, make, have made, use, sell, have sold, offer for sale, market, export, import and otherwise commercialize Products in
the Field, on the terms and subject to the conditions set forth herein.

 

Now,
Therefore, in consideration of the foregoing
premises and the mutual covenants contained herein, the receipt and sufficiency of which are hereby acknowledged, the Parties
hereby agree as follows:

 

Article
1.

DEFINITIONS

 

Unless
specifically set forth to the contrary herein, the following terms shall have the respective meanings set forth below:

 

1.1
“Accounting Standards” shall mean (a) U.S. generally accepted accounting principles or (b) international financial
reporting standards; in either case, consistently applied throughout the organization of a Party (or a Related Party, as applicable).

 

1.2
“Act” shall mean, as applicable, the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§301
et seq., and/or the Public Health Service Act, 42 U.S.C. §§262 et seq., as such may be amended from time to time.

 

    	 	 	 

     

    

 

CONFIDENTIAL

 

1.3
“Administrator” shall have the meaning provided in Section 11.2.

 

1.4
“Advisory Period” shall have the meaning provided in Section 2.3(d).

 

1.5
“Affiliate” shall mean, with respect to any Person, any other Person that directly or indirectly controls, is
controlled by or is under common control with such Person. A Person shall be deemed to control another Person if such Person possesses
the power to direct or cause the direction of the management, business and policies of such Person, whether through the ownership
of fifty percent (50%) or more of the voting securities of such Person, by contract or otherwise.

 

1.6
“Agent” means any active pharmaceutical ingredient for use in the diagnosis, cure, treatment, management or prevention
of disease in humans.

 

1.7
“Agreement” shall mean this License Agreement, including all Schedules and Exhibits hereto, as it may be amended,
supplemented or modified from time to time in accordance with its terms.

 

1.8
“Applicable Laws” shall mean the applicable laws and regulations of any jurisdiction, which are applicable to
any of the Parties or their respective Affiliates in carrying out activities hereunder or to which any of the Parties or their
respective Affiliates in carrying out the activities hereunder is subject, and shall include all statutes, enactments, acts of
legislature, laws, ordinances, rules, regulations, notifications, guidelines, policies, directions, directives and orders of any
statutory authority, tribunal, board, or court or any central or state government or local authority or other governmental entity
in such jurisdictions.

 

1.9
“Bankruptcy Laws” shall have the meaning provided in Section 12.1.

 

1.10
“Candidate” shall mean any Agent intended to prevent or intercept a pathological process caused, triggered, or
otherwise facilitated by coxsackie B virus infection, including for the prevention or interception of type I diabetes and celiac
disease, and specifically including any diagnostic tools or applications designed to detect any of the foregoing.

 

1.11
“CBV” shall mean Vactech’s Group B coxsackie virus vaccine platform.

 

1.12
“CBV Patent Rights” shall mean Vactech Patent Rights that are specific to CBV that are (i) set forth on
Exhibit A under the heading “CBV Patent Rights”, or (ii) Controlled by Vactech or any of its Affiliates as of the
Effective Date, or at any time during the Term. The foregoing shall include any modifications to the Vactech Patent Rights or
CBV Patent Rights conceived, made or reduced to practice by Vactech during the Term. In no event shall any Vactech Patent Rights
that are specific to asthma and allergy that are listed in Exhibit B be included within the CBV Patent Rights.

 

    	 	-2-	 

     

    

 

CONFIDENTIAL

 

1.13
“Claim” shall have the meaning provided in Section 10.1.

 

1.14
“Combination Product” shall mean a Product which includes one or more Other Actives in combination with a Candidate.
All references to Product in this Agreement shall be deemed to include Combination Product.

 

1.15
“Commercial Milestone” shall have the meaning provided in Section 4.2(b).

 

1.16
“Commercially Reasonable Efforts” shall mean, with respect to the efforts to be expended by a Party with respect
to any objective, the level of reasonable, diligent, good faith efforts that biopharmaceutical companies typically devote to products
owned by them that are at a similar stage in their development or product life and are of similar market potential taking into
account efficacy, safety, approved labeling, the competitiveness of alternative products in the marketplace, the patent and other
proprietary position of the product, the likelihood of regulatory approval, the profitability of the product, and other relevant
factors. As used in this Section 1.16 “biopharmaceutical companies” shall mean companies in the biopharmaceutical
industry of a size and stage of development similar to that of such Party, including having human pharmaceutical product candidates
or products in a similar stage of development to the Products. Commercially Reasonable Efforts shall be determined on a market-by-market
and Product-by-Product basis, and it is anticipated that the level of effort will be different for different markets, and will
change over time, reflecting changes in the status of the Product and the market(s) involved. Without limiting the foregoing,
Commercially Reasonable Efforts shall include the periodic creation and review of reasonable budgets, development plans and commercialization
plans for each Product, as applicable, on a market specific basis and reasonable efforts to adhere to such budgets, development
plans and commercialization plans.

 

1.17
“Competitive Infringement” shall have the meaning provided in Section 8.4.

 

1.18
“Confidential Information” shall mean any and all Information, whether communicated in writing or orally or by
any other method, which is provided by or on behalf of one Party to the other Party in connection with this Agreement or pursuant
to that certain Confidential Disclosure Agreement between Vactech and Creative BioVentures Corp. dated February 1st,
2016.

 

1.19
“Control”, “Controls” or “Controlled by” shall mean, with respect to any
Patent Rights, Information, Know How or other intellectual property rights, the possession by Person of the ability (whether by
ownership, license or other right, other than pursuant to a license granted under this Agreement) to grant access
to, or a license or sublicense of, such Patent Rights, Know-How, Information or other intellectual property rights without violating
the terms of any agreement or other arrangement with any other Person.

 

    	 	-3-	 

     

    

 

CONFIDENTIAL

 

1.20
“Cover” means (a) with respect to Know-How, such Know-How was used in making, having made, using, selling, offering
to sell, importing, having sold, exporting or making improvements to the Product, and (b) with respect to a Patent Right, a Valid
Patent Claim would (absent a license thereunder or ownership thereof) be Infringed by making, having made, using, selling, offering
to sell, importing, having sold, exporting or making improvements to the Product including research and development. Cognates
of the word “Cover” shall have correlative meanings.

 

1.21
“Deferral Notice” shall have the meaning provided in Section 4.2(a)(ii).

 

1.22
“Developmental Milestone” shall have the meaning provided in Section 4.2(a).

 

1.23
“Dispute” shall have the meaning provided in Section 11.1.

 

1.24
“Effective Date” shall have the meaning provided in the Preamble.

 

1.25
“EMA” shall mean the European Medicines Agency or any successor entity thereto.

 

1.26
“European Market” shall mean France, Germany, Italy, Spain, Sweden, Finland and United Kingdom.

 

1.27
“Export Control Laws” shall mean all applicable U.S. laws and regulations relating to (a) sanctions and embargoes
imposed by the Office of Foreign Assets Control of the U.S. Department of Treasury or (b) the export or re-export of commodities,
technologies, or services, including the Export Administration Act of 1979, 24 U.S.C. §§2401-2420, the International
Emergency Economic Powers Act, 50 U.S.C. §§1701-1706, the Trading with the Enemy Act, 50 U.S.C. §§1 et. seq.,
the Arms Export Control Act, 22 U.S.C. §§2778 and 2779, and the International Boycott Provisions of Section 999 of the
U.S. Internal Revenue Code of 1986 (as amended).

 

1.28
“FCPA” shall mean the U.S. Foreign Corrupt Practices Act (15 U.S.C. §§78dd-1, et. seq.) as amended.

 

1.29
“FDA” shall mean the U.S. Food and Drug Administration and any successor entity thereto.

 

1.30
“Field” shall mean any and all diagnostic, therapeutic and preventative uses in humans.

 

    	 	-4-	 

     

    

 

CONFIDENTIAL

 

1.31
“First Commercial Sale” shall mean, with respect to a given Product in a given country, the first commercial transfer
or disposition for value of such Product by Provention or a Related Party to a Third Party (other than a Related Party) for end
use or consumption of such Product in such country after receipt of Marketing Approval for such Product in such country, excluding,
however, transfers or dispositions of Product, without consideration: (i) in connection with patient assistance programs; (ii)
for charitable or promotional purposes; (iii) for preclinical, clinical, regulatory or governmental purposes or under so-called
“named patient” or other limited access programs; or (iv) for use in any tests or studies reasonably necessary to
comply with Applicable Law, regulation or request by a Regulatory Authority. For clarity, First Commercial Sale shall be determined
on a Product-by-Product and country-by-country basis.

 

1.32
“First European Indication” shall have the meaning provided in Section 4.2.

 

1.33
“First ROW Indication” shall have the meaning provided in Section 4.2.

 

1.34
“First US Indication” shall have the meaning provided in Section 4.2.

 

1.35
“Founders Stock” shall have the meaning provided in Section 4.1.

 

1.36
“Founding Scientists” shall mean Dr. Mikael Knip and Dr. Heikki Hyöty.

 

1.37
“Generic Version” shall mean, with respect to a Product, on a country-by-country basis, a pharmaceutical product
that: (a) is sold in a given country by a Third Party, other than a Related Party, a licensee or sublicensee of a Related Party,
or any other Person in a chain of distribution originating from Provention, a Related Party or any of their respective licensees
or sublicensees; (b) contains the same Candidate (and, if applicable, the same Other Active(s)) as such Product in the same dosage
form as such Product; and (c) has been approved for marketing by the relevant Regulatory Authority in such country in reliance
on the Marketing Approval for such Product in such country, including any such pharmaceutical product that has been approved for
marketing (i) in the United States, pursuant to Section 505(b)(2) or Section 505(j) of the Act (21 U.S.C. §355(b)(2) or 21
U.S.C. §355(j), respectively), (ii) in the European Union or a European Union member state, as a “generic medicinal
product” pursuant to Article 10 of Parliament and Council Directive 2001/83/EC as amended (including an application under
Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision), or (iii)
in any other country or jurisdiction, pursuant to any equivalent of the foregoing laws, regulations or directives, wherein the
approval of such pharmaceutical product is based on reference to the Marketing Approval for such Product in such country and a
demonstration of bio-equivalence to such Product and which may be substituted for the Product without any action by the physician
or health care practitioner.

 

1.38
“GCP” shall mean the then current “good clinical practices” as such term is defined from time to time
by the FDA, EMA or other Regulatory Authority of competent jurisdiction pursuant to its regulations, guidelines or otherwise,
as applicable.

 

    	 	-5-	 

     

    

 

CONFIDENTIAL

 

1.39
“GLP” shall mean the then current “good laboratory practices” as such term is defined from time to
time by the FDA, EMA or other Regulatory Authority of competent jurisdiction pursuant to its regulations, guidelines or otherwise,
as applicable.

 

1.40
“GMP” shall mean the then current “good manufacturing practices” as such term is defined from time
to time by the FDA, EMA or other Regulatory Authority of competent jurisdiction pursuant to its regulations, guidelines or otherwise,
as applicable.

 

1.41
“IND” shall mean an investigational new drug application, clinical study application, clinical trial exemption,
or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory
Authority in conformance with the requirements of such Regulatory Authority, including any such application filed with the FDA
pursuant to 21 CFR Part 312.

 

1.42
“Indemnified Party” shall have the meaning provided in Section 10.3.

 

1.43
“Indemnifying Party” shall have the meaning provided in Section 10.3

 

1.44
“Indication” shall mean a separate and distinct disease or medical condition in humans: (a) which a Product is
intended to treat or prevent, as evidenced by the protocol for a clinical trial of such Product or by the proposed Product labeling
in an NDA filed with a Regulatory Authority for such Product; or (b) which is contained in a Product’s labeling approved
by a Regulatory Authority as part of the Marketing Approval for such Product.

 

1.45
“Information” shall mean any and all proprietary data, information, materials and know-how (whether patentable
or not) that are not in the public domain, including, (a) ideas, discoveries, inventions, improvements, technology or trade secrets,
(b) pharmaceutical, chemical and biological materials, products, components or compositions, (c) methods, procedures, formulas,
processes, tests, assays, techniques, regulatory requirements and strategies, (d) biological, chemical, pharmacological, toxicological,
pharmaceutical, physical and analytical, clinical, safety, manufacturing and quality control data and information related thereto,
(e) technical and non-technical data and other information related to the foregoing, and (f) drawings, plans, designs, diagrams,
sketches, specifications or other documents containing or relating to such information or materials.

 

1.46
“Infringe” or “Infringement” means any infringement as determined by Applicable Law, including,
without limitation, direct infringement, contributory infringement or any inducement to infringe.

 

1.47
“Initiates” or “Initiation” shall mean, with respect to a human clinical trial, the administration
of the first dose to the first patient/subject in such trial.

 

    	 	-6-	 

     

    

 

CONFIDENTIAL

 

1.48
“Invention” shall mean any invention, whether or not patentable, made in the course and as a result of the conduct
of the activities contemplated by this Agreement.

 

1.49
“JAMS” shall mean Judicial Arbitration and Mediation Services, Inc.

 

1.50
“Janssen” shall have the meaning provided in the Recitals.

 

1.51
“Janssen Assets” shall mean Janssen’s (i) colony stimulating factor 1 receptor inhibitor and (ii) human
anti toll-like receptor 3 monoclonal antibody programs, in each case as more fully described in any license or collaboration agreement
entered into between Provention and Janssen with respect thereto.

 

1.52
“Joint Invention” shall have the meaning provided in Section 8.1.

 

1.53
“Joint Patent Rights” shall have the meaning provided in Section 8.1.

 

1.54
“Know-How” shall mean any and all Information related to CBV, Virus-Like Particle Technology and/or a Product,
or any formulation, product improvement and/or indication thereof, or necessary or useful for the development, manufacture, commercialization
or use of any of the foregoing; but excluding, in each case, Information specific to any Other Active.

 

1.55
“Losses” shall have the meaning provided in Section 10.1.

 

1.56
“Marketing Approval” shall mean all approvals from the relevant Regulatory Authority in a given country necessary
to market and sell a pharmaceutical product in such country, including pricing and reimbursement approvals if required for marketing
or sale of such product in such country.

 

1.57
“NDA” shall mean: (a) in the United States, a New Drug Application (as more fully defined in 21 CFR 314.5, et
seq.) filed with the FDA, or any successor application thereto; or (b) in any other country or group of countries, the equivalent
application or submission for approval to market a pharmaceutical product filed with the governing Regulatory Authority in such
country or group of countries.

 

1.58
“Net Sales” shall mean the gross amounts invoiced for sales or other dispositions of Products by or on behalf
of Provention or any of its Related Parties (each, a “Selling Party”) to Third Parties (other than Related
Parties), less the following deductions actually incurred, allowed, paid, accrued or otherwise specifically allocated to Products
by the Selling Party, all in compliance with applicable Accounting Standards, consistently applied by the Selling Party:

 

(a)
normal and customary trade discounts, including trade, cash and quantity discounts or rebates credits or refunds, actually
allowed or taken;

 

    	 	-7-	 

     

    

 

CONFIDENTIAL

 

(b)
credits or allowances actually granted or made for rejection of or return of previously sold Products, including recalls,
or for retroactive price reductions and billing errors or for stocking allowances;

 

(c)
governmental and other rebates (or credits or other equivalents thereof) actually granted to managed health care organizations,
commercial insurance companies, pharmacy benefit managers (or equivalents thereof), distributors, national, state/provincial,
local, and other governments, their agencies and purchasers, and reimbursers, or to trade customers;

 

(d)
reasonable fees paid to wholesalers, distributors, selling agents(excluding sales representatives of the Selling Party), group
purchasing organizations, Third Party payors, other contractees and managed care entities, in each case with respect to the Product;

 

(e)
charges separately invoiced for freight, insurance, transportation, postage and handling;

 

(f)
taxes, custom duties or other governmental charges (including any tax, such as a value added or similar tax or government
charge, but excluding what is commonly known as income tax) levied on or measured by the billing amount for Products, as adjusted
for rebates and refunds; and

 

(g)
bad debts or provision for bad debts deductions actually written off during the applicable accounting period following the
applicable Accounting Standards used by the Selling Party.

 

In
no event shall any particular amount identified above be deducted more than once in calculating Net Sales (i.e., no “double
counting” of deductions).

 

On
a country-by-country basis, if a Product under this Agreement is sold in the form of a Combination Product in a country, Net Sales
for the purpose of determining royalties due hereunder shall be calculated as follows:

 

(i)
Where all active ingredients in such Combination Product are sold separately in such country, Net Sales shall be calculated
by multiplying actual Net Sales of such Combination Product in such country as determined under the first paragraph of this Section
1.58 by the fraction A/(A+B), where A is the net invoice price of the Product as sold separately in such country, and B is the
sum of the net invoice prices of the Other Active(s) in the combination.

 

(ii)
If the Product component of the Combination Product is sold separately in such country, but none of such Other Active(s) is
sold separately in such country, Net Sales shall be calculated by multiplying actual Net Sales of such Combination Product in
such country as determined under the first paragraph of this Section 1.58 by the fraction A/C, where A is the net invoice price
of such Product component as sold separately in such country, and C is the net invoice price of the Combination Product in such
country.

 

    	 	-8-	 

     

    

 

CONFIDENTIAL

 

(iii)
If the Product component of the Combination Product is not sold separately in such country, but the Other Active(s) are sold
separately in such country, Net Sales shall be calculated by multiplying actual Net Sales of such Combination Product in such
country as determined under the first paragraph of this Section 1.58 by the fraction (C-D)/C, where C is the net invoice price
of the Combination Product in such country, and D is the sum of the net invoice prices charged for the Other Active(s) in the
Combination Product in such country.

 

(iv)
If none of the Product component and the Other Active(s) are sold separately in such country, Net Sales for the purpose of
determining royalties due hereunder for the Combination Product shall be determined by mutual agreement of the Parties in good
faith taking into account the perceived relative value contributions of the Product portion of the Combination Product and the
Other Active(s) in the Combination Product. In case of disagreement, an independent expert agreed upon by both Parties or, failing
such agreement, designated by the International Chamber of Commerce, shall determine such relative value contributions and such
determination shall be final and binding upon the Parties.

 

In
the event Product is “bundled” for sale together with one or more other products in a country (a “Product
Bundle”), then Net Sales for such Product sold under such arrangement shall be determined on a country-by-country
basis by mutual agreement of the Parties in good faith taking into account the relative value contributions of the Product and
the other products in the Product Bundle, as reflected in their individual sales prices. In case of disagreement, an independent
expert agreed upon by both Parties or, failing such agreement, the International Chamber of Commerce shall determine such relative
value contributions and such determination shall be final and binding upon the Parties. In addition, if a Selling Party provides
discounts or allowances with respect to a Product Bundle, such discounts and allowances shall be allocated (for purposes of the
deductions used in calculating Net Sales as above) between the Product and the other products in the Product Bundle in a manner
that does not unfairly or inappropriately bias the level of discounting against the Product as compared to the other products
in such Product Bundle.

 

For
clarification, sale of Product by a Selling Party to another Selling Party for resale by such entity to a Third Party (other than
a Related Party) shall not be deemed a sale for purposes of this definition of “Net Sales,” provided that the subsequent
resale is included in the computation of Net Sales. Further, transfers or dispositions of Product, without consideration: (A)
in connection with patient assistance programs; (B) for charitable or promotional purposes; (C) for preclinical, clinical, regulatory
or governmental purposes or under so-called “named patient” or other limited access programs; or (D) for use in any
tests or studies reasonably necessary to comply with Applicable Law, regulation or request by a Regulatory Authority, shall not,
in each case of (A) through (D), be deemed sales of such Product for purposes of this definition of “Net Sales.”

 

    	 	-9-	 

     

    

 

CONFIDENTIAL

 

1.59
“Other Active” shall mean any active pharmaceutical ingredient that is not a Candidate.

 

1.60
“Other Joint Patent Claims” shall have the meaning provided in Section 8.3(b)(ii).

 

1.61
“Other Major Market” means China, Japan, Brazil, Argentina, Australia, Russia, India, Saudi Arabia and
South Korea.

 

1.62
“Party” shall mean Provention and Vactech, individually, and “Parties” shall mean Provention and Vactech,
collectively.

 

1.63
“Patent Certification” shall have the meaning provided in Section 8.4.

 

1.64
“Patent Rights” shall mean (i) patents and patent applications (which for the purposes of this Agreement shall
be deemed to include certificates of invention and applications for certificates of invention); (ii) any and all divisionals,
continuations, continuations-in-part, reissues, renewals, substitutions, registrations, re-examinations, revalidations, patent
term extensions, supplementary protection certificates and the like of any such patents and patent applications; and (iii) any
and all foreign equivalents of the foregoing.

 

1.65
“Person” means any individual, partnership, joint venture, limited liability company, corporation, firm, trust,
association, unincorporated organization, governmental authority or agency, or any other entity not specifically listed herein.

 

1.66
“Phase 2b Clinical Trial” shall mean a human clinical trial of Product, the principal purpose of which is a determination
of safety and an assessment of its efficacy in the target patient population, as described in 21 C.F.R. 312.21(b) (as amended
or replaced), or a similar clinical study prescribed by a Regulatory Authority in a foreign country or region.

 

1.67
“Phase 3 Clinical Trial” shall mean a human clinical trial of a Product designed to: (i) establish that such Product
is safe and efficacious for its intended use; (ii) define warnings, precautions and adverse reactions that are associated with
the Product in the dosage range to be prescribed; and (iii) support regulatory approval of such Product that would satisfy the
requirements of 21 CFR 312.21(c) or its non-US equivalents.

 

1.68
“Pivotal” shall mean, with respect to a clinical trial, any human clinical trial that the applicable Regulatory
Authority has agreed, whether before Initiation of such trial (e.g., pursuant to a special protocol assessment agreement
with the FDA) or after Initiation of such trial (e.g., based on an interim data analysis), is sufficient to form the primary
basis of an efficacy claim in an NDA submission.

 

    	 	-10-	 

     

    

 

CONFIDENTIAL

 

1.69
“Product” shall mean any pharmaceutical composition or preparation (in any and all dosage forms) in final form
containing one or more Candidates, including any Combination Product that was developed, manufactured or commercialized utilizing
Vactech Technology.

 

1.70
“Provention” shall have the meaning provided in the Preamble.

 

1.71
“Provention Indemnitees” shall have the meaning provided in Section 10.2.

 

1.72
“Provention Know-How” shall mean all Know-How Controlled by Provention or its Affiliates during the Term, including
all Know-How developed or generated by or on behalf of Provention or any of its Affiliates in the course of conducting research,
development, manufacturing, regulatory or commercialization activities contemplated by this Agreement.

 

1.73
“Provention Patent Rights” shall mean all Patent Rights Controlled by Provention or its Affiliates during the
Term that claim or cover the composition of matter, manufacture or use of any Candidate and/or Product, but specifically excluding
the Janssen Assets and the CBV Patent Rights. The Provention Patent Rights shall include Provention’s (and its Affiliates’)
rights in Joint Patent Rights.

 

1.74
“Reference Samples” shall have the meaning given to such term in Section 2.3(b).

 

1.75
“Regulatory Authority” shall mean any country, federal, regional, supranational, state or local regulatory agency,
department, bureau or other governmental or regulatory authority having the administrative authority to regulate the development
or marketing of pharmaceutical products in any country or other jurisdiction.

 

1.76
“Regulatory Documentation” shall mean all regulatory applications, registrations, licenses, authorizations and
approvals (including all INDs, NDAs and Marketing Approvals), all correspondence submitted to or received from Regulatory Authorities
(including minutes and official contact reports relating to any communications with any Regulatory Authority), and all reports
and documentation in connection with clinical studies and tests (including study reports and study protocols, and copies of all
interim study analyses), and all data contained in any of the foregoing, including all INDs, NDAs, advertising and promotion documents,
manufacturing data, drug master files, clinical data, adverse event files and complaint files, in each case related to CBV, Virus-Like
Particle Technology or a Product.

 

1.77
“Regulatory Exclusivity” shall mean marketing or manufacturing exclusivity conferred by the applicable Regulatory
Authority in a country or jurisdiction on the holder of a Marketing Approval for a pharmaceutical product in such country or jurisdiction,
including, by way of example and not of limitation, regulatory data exclusivity, orphan drug exclusivity, new chemical entity
exclusivity and pediatric exclusivity.

 

    	 	-11-	 

     

    

 

CONFIDENTIAL

 

1.78
“Related Party” shall mean each of Provention’s Affiliates and its and their respective Sublicensees hereunder.

 

1.79
“Relevant Patent Rights” shall have the meaning provided in Section 8.4(a).

 

1.80
“Relevant Joint Patent Claims” shall have the meaning provided in Section 8.3(b)(i).

 

1.81
“Relevant Vactech Patent Claims” shall have the meaning provided in Section 8.3(a)(i).

 

1.82
“Royalty Term” shall have the meaning provided in Section 4.4.

 

1.83
“Rules” shall have the meaning provided in Section 11.2.

 

1.84
“Sale Transaction” shall have the meaning provided in Section 12.5(a).

 

1.85
“Scientific Advisory Board” shall mean that group of experts in their fields, selected by the Provention management
team, to provide strategic guidance and direction for Provention’s scientific research and development programs.

 

1.86
“Sublicensee” shall mean a Third Party sublicensee under the license granted by Vactech to Provention pursuant
to Section 2.1, whether such Third Party’s sublicense was granted to it directly by Provention or its Affiliate or indirectly
through one or more tiers of sublicense.

 

1.87
“Term” shall have the meaning provided in Section 9.1.

 

1.88
“Territory” shall mean the entire world.

 

1.89
“Third Party” shall mean an entity other than Provention and its Affiliates, and Vactech and its Affiliates.

 

1.90
“Third Party Acquirer” shall have the meaning provided in Section 12.5(a).

 

1.91
“Transition and Advisory Fee” shall have the meaning provided in Section 2.3(g).

 

1.92
“Transition and Advisory Lump Sum Payment” shall have the meaning provided in Section 2.3(g).

 

    	 	-12-	 

     

    

 

CONFIDENTIAL

 

1.93
“Transition and Advisory Monthly Fee” shall have the meaning provided in Section 2.3(g).

 

1.94
“Transition Period” shall have the meaning provided in Section 2.3(e).

 

1.95
“Transition Services” shall have the meaning provided in Section 2.3(g).

 

1.96
“Vactech” shall have the meaning provided in the Preamble.

 

1.97
“Vactech Indemnitees” shall have the meaning provided in Section 10.1.

 

1.98
“Vactech Know-How” shall mean all Know-How Controlled by Vactech or any of its Affiliates as of the Effective
Date, or that is developed or Controlled by Vactech after the Effective Date, related to CBV, Virus-Like Particle Technology or
otherwise necessary or useful for the research, development, manufacture and/or commercialization of any Product.

 

1.99
“Vactech Patent Rights” shall mean any and all Patent Rights Controlled by Vactech or any of its Affiliates as
of the Effective Date, or at any time during the Term, that claim or Cover the composition, manufacture, use, sale, offer for
sale and/or import of any Product in the Field, including, but not be limited to: (i) the CBV Patent Rights; (ii) the VLP Patent
Rights; (iii) Vactech’s interest in any Joint Patent Rights; and (iv) those in-licensed by Vactech under any agreement with
a Third Party that constitute CBV Patent Rights or VLP Patent Rights.

 

1.100
“Vactech Technology” shall mean Vactech Patent Rights and Vactech Know-How.

 

1.101
“Valid Patent Claim” shall mean a claim of an issued and unexpired patent included within the Vactech Patent Rights,
which claim has not been revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent
jurisdiction (which decision is not appealable or has not been appealed within the time allowed for appeal), and which claim has
not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise.

 

1.102
“Virus-Like Particle Technology” shall mean any recombinant protein technology available to Vactech (in insect,
yeast, mammalian or other cells) used to express viral proteins which form a virus-like particle with structural proteins of the
mature virus but lacking viral genome. The term shall include the IMAVACTM technology and any modifications and conjugations
of the viral particles by protein engineering or other means.

 

1.103
“VLP Patent Rights” shall mean Vactech Patent Rights that pertain to Virus-Like Particle Technology, including,
but not limited to, those listed on Exhibit A under the heading “VLP Patent Rights”. In no event shall any Vactech
Patent Rights that are specific to asthma and allergy that are listed in Exhibit B be included within the VLP Patent Rights.

 

    	 	-13-	 

     

    

 

CONFIDENTIAL

 

Article
2.

LICENSE GRANT

 

2.1
License Grant. Subject to the terms and conditions of this Agreement, Vactech hereby grants to Provention (a) an exclusive
(even as to Vactech and its Affiliates), royalty-bearing license including the right to sublicense through multiple tiers of sublicense
as well as the right to modify and amend, under the Vactech Technology related to CBV and all Vactech Patent Rights other than
the VLP Patent Rights and Vactech Technology covering vaccine development and manufacture generally, and (b) a non-exclusive,
royalty-bearing license including the right to sublicense through multiple tiers of sublicense as well as the right to modify
and amend, under the VLP Patent Rights (other than those referred to in the clause (a) above, as to which such license is exclusive)
and the Vactech Know-How necessary or useful in connection with the development, manufacture, testing or commercialization of
any Candidate but that is not specific for any Products; in each case, solely to discover, develop, make, have made, use, sell,
have sold, offer for sale, market, export, import and otherwise commercialize Candidates and Products in the Field in the Territory.

 

2.2
Sublicensing. Provention shall provide Vactech with a copy of any sublicense agreement entered into by Provention or its Affiliate
within thirty (30) days of its execution.

 

2.3
Transition Services and Consulting.

 

(a)
Vactech Know-How. Within thirty (30) days after the Effective Date, Vactech shall transfer and or provide to Provention copies
of: (i) all preclinical and other data and documentation pertaining to the Vactech Technology; (ii) all lab books, files, patent
office correspondence and other documentation reasonably necessary for Provention to assume responsibility and control over prosecution,
maintenance, defense, and enforcement of Vactech Patent Rights; and (iii) any and all other information and documentation reasonably
necessary to successfully transition the licensed Vactech Technology to Provention or its designee, including, but not limited
to patent prosecution histories, file wrappers and other information related to the maintenance of the Vactech Patent Rights;
in each case, to the extent in Vactech’s possession and Control or otherwise obtainable by Vactech (whether generated by
or on behalf of Vactech). To the extent such data exists in electronic form, Vactech may provide the same to Provention in electronic
form.

 

(b)
Reference Samples. At Provention’s request, Vactech shall promptly transfer to Provention reference samples of CBV,
Virus-Like Particle Technology or other licensed Vactech Technology (or intermediates pertaining to either) (collectively, “Reference
Samples”), for Provention to use as a basis for analysis, comparison or any other use permitted under the terms of this
Agreement. Provention shall reimburse Vactech for the reasonable and documented shipping and logistics costs associated with the
delivery of the foregoing.

 

    	 	-14-	 

     

    

 

CONFIDENTIAL

 

(c)
Manufacturing Technology Transfer. Within thirty (30) days after the Effective Date Vactech shall transfer or cause to be
transferred (including, if applicable, from any Third Party contract manufacturers) to Provention, or a Third Party manufacturer
designated by Provention, copies of all Vactech Know-How (whether in the possession of Vactech, its Affiliate or a Third Party
contract manufacturer), in order to enable Provention (or its designee) to develop and manufacture Products which comprise Candidates
for use in the Field using the processes employed by or on behalf of Vactech to develop and manufacture such Products. In addition,
for a period equal to the Advisory Period, Vactech shall provide additional consulting services as reasonably requested by Provention
to enable Provention to effectively establish manufacturing processes for Candidates.

 

(d)
Scientific Advisory Board. For a period of at least eighteen (18) months from the Effective Date (the “Advisory Period”),
Provention shall cause the Founding Scientists to serve on Provention’s Scientific Advisory Board. During the Advisory Period,
the Founding Scientists will each provide no greater than fourteen (14) hours per month of consulting services, as requested by
Provention, in support of Provention’s research and development objectives related to the Candidates and Products in the
Field. Provention shall reimburse Vactech for all reasonable and documented out-of-pocket expenses (including necessary travel)
incurred by the Founding Scientists solely in performing their duties as Scientific Advisory Board members; provided that Provention
shall not be obligated to reimburse Vactech for expenses that exceed one thousand dollars ($1,000) individually per trip, unless
prior written approval has been obtained by Vactech or one or both of the Founding Scientists to incur such expenses. Vactech
shall provide ongoing updates on any relevant research being performed during the Term at intervals to be agreed upon in good
faith between the Parties.

 

(e)
Intellectual Property. During the period beginning on the Effective Date and ending on the date that the Vactech Know-How
is effectively transferred to Provention in accordance with Section 2.3(a) above (the “Transition Period”),
Vactech shall be responsible for the prosecution, maintenance, defense, and enforcement of Vactech Patent Rights; provided that,
during the Transition Period, Vactech shall consult with Provention and shall not unreasonably reject any comments from Provention
prior to taking any action in connection with its obligations under this Section 2.3(e). In no event shall the Transition Period
exceed thirty (30) Days. Vactech shall execute its obligations under this Section 2(e) with no less diligence than it would
otherwise employ in the prosecution, maintenance, defense, and enforcement of its intellectual property rights. Notwithstanding
the foregoing, any action or inaction by Vactech with respect to the Vactech Patent Rights that could materially affect Provention’s
rights under this Agreement shall be subject to Provention’s consent, in its sole discretion.

 

    	 	-15-	 

     

    

 

CONFIDENTIAL

 

(f)
Regulatory Documentation. Within thirty (30) days after the Effective Date, Vactech shall transfer and assign to Provention
all Regulatory Documentation in Vactech’s (or any of its Affiliates’) Control, including, if applicable, the transfer
and assignment of any IND related to the Vactech Technology to Provention.

 

(g)
Transition and Advisory Consideration. In consideration for the services to be provided by Vactech under this Section 2.3
(the “Transition Services”), (i) within thirty (30) days of Effective Date, Provention shall pay to Vactech
a fee equal to $[*****] (the “Transition and Advisory Lump Sum Payment”), and (ii) assuming the provision of
Transition Services in accordance with this Agreement by Vactech during the period beginning on the Effective Date and ending
on the sixth (6th) month anniversary of the Effective Date, Provention shall, beginning on the sixth (6th)
month anniversary of the Effective Date, pay Vactech $[*****] for each month thereafter during the Advisory Period in which Transition
Services are provided in accordance with this Section 2.3 (the “Transition and Advisory Monthly Fee”, and together
with the Transition and Advisory Lump Sum Payment, the “Transition and Advisory Fee”). Unless this Agreement
is terminated in accordance with its terms prior to the expiration of the Advisory Period, the aggregate Transition and Advisory
Fee payments that Vactech will be entitled to receive for completion of the Transition Services as provided in this Section 2.3
shall equal $[*****]. In the event that this Agreement is terminated prior to the expiration of the Advisory Period, the aggregate
Transition and Advisory Fee shall equal (a) the Transition and Advisory Lump Sum Payment ($[*****]), plus (b) (i) the Transition
and Advisory Monthly Fee ($[*****]), multiplied by (ii) the number of full calendar months the Agreement was in effect
after the sixth (6th) month anniversary of the Effective Date. The Transition and Advisory Monthly Fee shall be payable
within thirty (30) days of the end of each month of the Advisory Period. Other than the Transition and Advisory Fee and the fees
and reimbursements specifically set forth in Sections 2.3(b) and (d) above, Provention shall have no responsibility for the payment
of any fees to Vactech or any costs or expenses incurred by Vactech in providing the services or deliverables set forth in this
Section 2.3.

 

2.4
Non-Compete. Vactech hereby covenants not to practice, and not to permit or cause any of its Affiliates or either Founding
Scientist to develop, use, make, have made, sell, have sold, offer for sale, export, import or otherwise commercialize
any Candidate or Product, or competitor thereof, in the Territory during the Term. Without limiting the generality of the foregoing,
Vactech shall not grant any rights or licenses to Vactech Technology or other proprietary technology Controlled by Vactech to
any Third Party for use with any Candidate during the Term. Notwithstanding the foregoing, the Founding Scientists may continue
to engage in academic research and publishing, but may not materially participate in the commercialization of the results of any
such research that would cause Vactech to violate any provision of this Agreement, including but not limited to the foregoing
covenant or and the obligations under Article 6.

 

    	 	-16-	 

     

    

 

CONFIDENTIAL

 

Article
3.

DEVELOPMENT, MANUFACTURING AND COMMERCIALIZATION

 

3.1
Responsibility. Provention (itself and/or with or through its Related Parties) shall be solely responsible, at its own expense,
for, and shall control all aspects of, worldwide development (including pre-clinical and clinical development), manufacture, registration
and commercialization (including marketing, promoting, selling, distributing and determining pricing for) Products in the Territory.
Without limiting the generality of the foregoing, Provention (itself and/or with or through its Related Parties) shall be solely
responsible for selecting Candidates for development and commercialization, preparing and submitting all required regulatory filings
in connection with obtaining and maintaining Marketing Approvals with respect to Products in the Field in the Territory, including
all INDs and NDAs. All of such submissions and other regulatory filings relating to Products shall be submitted in the name of,
and owned by, Provention (or a Related Party, as applicable).

 

3.2
Diligence. Provention (itself and/or with or through its Related Parties) shall use Commercially Reasonable Efforts to develop,
seek Marketing Approval for, and commercialize a Product throughout the Territory during the Term. If Provention affirmatively
determines that it will not pursue development and/or commercialization of a Product in any given country, it shall promptly notify
Vactech of such determination. Vactech shall have the option, to be exercised within ninety(90) days of receipt of such notification,
to treat such notification as a partial termination of this Agreement pursuant to Section 9.4 herein with respect to such country.

 

3.3
Records. Provention shall maintain, or cause to be maintained, complete and accurate records of all development work conducted
by or on behalf of Provention with respect to Products, including all results, data, inventions and developments made in the performance
of such development work. All such records maintained shall be in sufficient detail and in good scientific manner appropriate
for patent and regulatory purposes.

 

3.4
Reports. On or before June 30th and December 31st of each year during the Term following the first anniversary
of the Effective Date, Provention shall deliver to Vactech a written progress report regarding, to the extent applicable, (i)
the status of any Product in development, (ii) any Product-related regulatory submissions and approvals, (iii) any Product-related
commercialization efforts in the Territory, and (iv) the status of any Product related patent applications in each country in
the Territory.

 

3.5
Compliance with Applicable Laws. Provention shall conduct, and shall cause its Related Parties to conduct, all development,
regulatory, manufacturing and commercialization activities with respect to Products anywhere in the world in compliance with all
Applicable Laws and, as applicable, GLP, GCP and/or GMP.

 

    	 	-17-	 

     

    

 

CONFIDENTIAL

 

Article
4.

PAYMENTS

 

4.1
Upfront Equity Issuance. In consideration for the rights and licenses granted to Provention hereunder and the services, Provention
shall issue to Vactech, as soon as practicable following the Effective Date and in no event later than thirty (30) business days
thereafter, two million (2,000,000) shares of Provention Common Stock, $.001 par value (the “Founders Stock”)
representing a twenty percent (20%) ownership share in Provention on the Effective Date. The Founders Stock shall (i) have the
rights, preferences and privileges set forth in the Amended & Restated Certificate of Incorporation to be filed with the Secretary
of State of the State of Delaware, in a form reasonably acceptable to Vactech, and (ii) be issued to Vactech pursuant to the terms
of a Subscription Agreement in a form reasonably acceptable to Vactech. Certain additional rights and obligations with respect
to the Founders Stock will be set forth in an Investor’s Agreement and Lock-Up Agreement, each in a form reasonably acceptable
to Vactech.

 

4.2
Milestone Payments.

 

(a)
Developmental Milestones. Subject to Section 4.2(c) below, within ninety (90) days of the first achievement of each
of the milestone events set forth in the table below by Provention or any Related Party, Provention shall provide Vactech with
written notice of such achievement and shall pay to Vactech the corresponding one-time milestone payment set forth below (each
a “Developmental Milestone”):

 

	Milestone
    Event	 	 	Milestone

                                         Payment	 
	First
    dosing of the first subject in a human clinical trial for a Product	 	$	[*****	]
	First
    dosing of the first subject in a Phase 2b Clinical Trial for a Product	 	$	[*****	]
	First
    dosing of the first subject in a Pivotal Phase 3 Clinical Trial for a Product	 	$	[*****	]
	First
    FDA Marketing Approval of a Product for any Indication (“First US Indication”)	 	$	[*****	]
	First
    EMA Marketing Approval of a Product in any country in the European Market for any Indication (“First European Indication”)	 	$	[*****	]
	First
    Marketing Approval of a Product in an Other Major Market (“First ROW Indication”)	 	$	[*****	]
	FDA
    Marketing Approval of a Product for any Indication other than the First US Indication	 	$	[*****	]
	EMA
    Marketing Approval of a Product in the European Market for any Indication other than the First European Indication	 	$	[*****	]
	Marketing
    Approval of a Product in an Other Major Market for any Indication other than the First ROW Indication	 	$	[*****	]

 

    	 	-18-	 

     

    

 

CONFIDENTIAL

 

(i)
Each of the above milestone payments shall only be paid once, for the first achievement of the corresponding milestone event
by any Product (regardless of the number of times such milestone event is achieved by a Product, the number of Indications for
which such milestone event is achieved by a Product, or the number of Products that achieve such milestone event, and regardless
of whether any such milestone event is achieved by the same Product that achieved any other milestone event or by a different
Product).

 

(ii)
Provention shall have the right to defer payment of the First US Indication or the First European Indication Developmental
Milestone for a period of up to twelve months from the date such Developmental Milestone would otherwise be due by delivering
a notice to Vactech stating its intention to effect such deferral (a “Deferral Notice”). In the event Provention
delivers a Deferral Notice to Vactech, the balance of the deferred Developmental Milestone payment shall accrue interest at a
rate equal to the twelve-month US Treasury Bill interest rate as published in the Wall Street Journal or any alternative source
agreed upon by the Parties on the date a deferral notice is delivered to Vactech plus three percent (3%), provided that
the interest rate shall in no cases be less than three percent (3%).

 

(iii)
Provention may offer, at its sole discretion, to pay any Developmental Milestone with equity in Provention. Any such offer
to pay a Development Milestone in Provention equity shall be subject to acceptance by Vactech in its sole discretion.

 

(b)
Commercial Milestones. Subject to Section 4.2(c) below, within sixty (60) days of the end of the calendar year in which
any of the milestone events set forth in the table below is first achieved by Provention or any Related Party, Provention shall
provide Vactech with written notice of such achievement and shall pay to Vactech the corresponding one-time milestone payment
set forth below (each a “Commercial Milestone”). Each Commercial Milestone payment will be paid only once,
for the first calendar year in which the corresponding Commercial Milestone event is achieved.

 

    	 	-19-	 

     

    

 

CONFIDENTIAL

 

	Milestone
    Event	 	 	Milestone

                                         Payment	 
	First
    calendar year in which annual Net Sales of all Products in the Territory exceed $[*****]	 	 	$[*****	]
	First
    calendar year in which annual Net Sales of all Products in the Territory exceed $[*****]	 	 	$[*****	]
	First
    calendar year in which annual Net Sales of all Products in the Territory exceed $[*****]	 	 	$[*****	]

 

(c)
Limitations on Milestone Payments. No Developmental Milestone shall be payable in connection with a trial, Indication
or Marketing Approval for a diagnostic Product. In addition, sales of a diagnostic Product shall not be included when calculating
Net Sales to determine if a Commercial Milestone payment is due and payable.

 

4.3
Royalties. Subject to Sections 4.5, 4.6 and 4.7 below, Provention shall pay royalties to Vactech on aggregate annual Net Sales
of all Products in the Territory by Provention and Related Parties in each calendar year of the Royalty Term at the applicable
rate(s) set forth below:

 

	Annual
    Net Sales Increments	 	 	Royalty

                                         Rate	 
	That
    portion of annual Net Sales of Products by Provention and Related Parties that is less than or equal to US$[*****]	 	 	[*****	]%
	That
    portion of annual Net Sales of Products by Provention and Related Parties that is greater than US$[*****]and less than or
    equal to US$[*****]	 	 	[*****	]%
	That
    portion of annual Net Sales of Products by Provention and Related Parties that is greater than US$[*****]	 	 	[*****	]%

 

 4.4
Royalty Term. Royalties under Section 4.3 shall be payable during the period of time commencing on the first date after Provention
and any Related Parties have collectively and in the aggregate received more than [*****] dollars ($[*****]) in Net Sales with
respect to Products sold in the Territory and ending on a country-by-country basis with respect to each Product upon the later
of: (a) 10 years from the date of First Commercial Sale of such Product in such country; and (b) expiration of the last-to-expire
Valid Patent Claim of the Vactech Patent Rights Covering the manufacture, use or sale of such Product in such country (the “Royalty
Term”). On a Product-by-Product and country-by-country basis, upon expiration of the Royalty Term for a Product
in a country, Provention’s license under Section 2.1 with respect to such Product in such country shall become fully-paid,
irrevocable and perpetual.

 

    	 	-20-	 

     

    

 

CONFIDENTIAL

 

4.5
Third Party Licenses.

 

(a)
Third Party Licenses. In the event that Provention determines that it is necessary to obtain one or more licenses to Patent
Rights of Third Parties in order to make, have made, use, offer to sell, sell or import a Product in a country (“Third
Party Patent Licenses”), fifty percent (50%) of the royalties actually paid to Third Parties under such Third Party
Patent Licenses by Provention for the sale of such Product in such country for a calendar quarter shall be creditable against
the royalty payments due Vactech by Provention with respect to Net Sales of such Product in such country for such calendar quarter;
provided, however, that in no event shall the royalties otherwise owed by Provention to Vactech for such calendar quarter in such
country be reduced by more than fifty percent (50%) as a result of any and all such offsets in the aggregate and further provided
that no such offset will be permitted to the extent that such offset reduces the royalty payable to Vactech below the royalty
payable to the subject third party.

 

4.6
Compulsory Licenses. If a compulsory license is granted to a Third Party with respect to Product in any country with a royalty
rate lower than the royalty rate under Section 4.3, then the royalty rate applicable to Net Sales of such Product in that country
under Section 4.3 shall be reduced to a rate which is [*****%] percentage points (i.e., [*****] basis points) less than
the rate paid by the compulsory licensee; provided, however, that if the royalty rate payable by the compulsory licensee
with respect to Net Sales of such Product in such country is [*****]% or less, then Provention shall pay to Vactech 50% of the
royalties received by Provention or its Affiliate with respect to Net Sales of such Product in such country by such compulsory
licensee.

 

4.7
Adjustment for Generic Competition. On a Product-by-Product and country-by-country basis, during any portion of the Royalty
Term for a Product in a country when no Valid Patent Claim of the Vactech Patent Rights covers the manufacture, use or sale of
such Product in such country and there is no Regulatory Exclusivity for such Product in such country, if one or more Generic Versions
of such Product account for 10% or more of aggregate unit sales of such Product and such Generic Version(s) in such country in
a calendar quarter, as determined by reference to applicable sales data obtained from IMS Health or from such other source for
such sales data as may be agreed upon by the Parties (provided that such other source, if any, shall be generally recognized as
a reliable source for pharmaceutical sales data among major pharmaceutical companies), then for the remainder of the Royalty Term
for such Product in such country, the royalties payable by Provention under Section 4.3 with respect to Net Sales of such Product
in such country shall be reduced by 50%.

 

    	 	-21-	 

     

    

 

CONFIDENTIAL

 

4.8
Provention Board of Directors Observer Rights. Until the earlier of (i) the end of the Term of this Agreement, (ii) when Vactech
holds less than 10% of the equity of Provention on a fully-diluted basis or (iii) Provention completes an initial underwritten
public offering of its securities, Provention shall invite a representative of Vactech, reasonably acceptable to Provention (the
“Representative”), to attend and participate in all meetings of the Board of Directors and committees
thereof in a non-voting observer capacity; provided, however, (i) that Provention reserves the right to withhold any information
and to exclude such Representative from any meeting, or any portion thereof, as is reasonably determined by the Chairman of the
Board or a majority of the members of the Board of Directors to be necessary to protect confidentiality of information, avoid
a material conflict of interest, or preserve attorney-client privilege; and (ii) that in no event shall the failure to provide
the notice described above invalidate in any way any action taken at a meeting of the Board of Directors or a committee thereof,
provided however that such failure shall constitute a breach of this Agreement by Provention unless the Representative attends
such meeting notwithstanding the failure to provide notice. The initial Representative shall be Dr. Heikki Hyöty. Such Representative
shall be entitled to receive the same compensation and reimbursement of expenses granted to members of the Board of Directors
generally.

 

Article
5.

PAYMENT; RECORDS; AUDITS

 

5.1
Payment; Reports. Royalties under Section 4.3 shall be calculated and reported for each calendar quarter during the Royalty
Term and shall be paid within ninety (90) days after the end of the calendar quarter. Each payment of royalties shall be accompanied
by a report of Net Sales of Products by Provention and Related Parties in sufficient detail to permit confirmation of the accuracy
of the payment made, including gross sales and Net Sales of Products on a Product-by-Product and country-by-country basis, the
deductions from gross sales (by major category as set forth in the definition of Net Sales), details of any royalty credits taken
pursuant to Section 4.5 on a Third Party Patent License-by-Third Party Patent License basis, any applicable reductions or adjustments
made pursuant to Section 4.6 and/or Section 4.7, the royalty payable, and the exchange rates used.

 

5.2
Exchange Rate; Manner and Place of Payment. All payment amounts in this Agreement are expressed in U.S. dollars, and all payments
hereunder shall be payable in U.S. dollars. When conversion of payments from any foreign currency is required, such conversion
shall be calculated using an exchange rate equal to the average of the interbank rates of exchange for such currency as reported
at OANDA.com, or should such rates cease to be published by OANDA, a successor or replacement agreed upon by the parties, during
the calendar quarter for which payment is due. All payments owed under this Agreement shall be made by wire transfer in immediately
available funds to the bank and account designated in writing by Vactech.

 

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CONFIDENTIAL

 

5.3
Income Tax Withholding. Vactech will pay any and all taxes levied on account of any payments made to it under this Agreement.
If Provention is advised in writing by its attorneys or accountant that Provention is required to withhold any portion of any
payment made to Vactech under this Agreement, Provention shall (a) deduct such taxes from the payment made to Vactech, (b) timely
pay the taxes to the proper taxing authority, (c) send proof of payment to Vactech and certify its receipt by the taxing authority
within 30 days following such payment, (d) reasonably cooperate with Vactech, if requested, to obtain available reductions, credits
or refunds of such taxes and (e) provide Vactech a copy of such written advisement or instructions at least thirty (30) days,
or such shorter period as reasonably practicable given the timing of the subject advice or instructions received by Provention,
in advance of such withholding. Without limiting the generality of the foregoing, upon request by Vactech, Provention shall provide
Vactech such information in Provention’s possession as may be reasonably necessary for Vactech to obtain the benefit of
any present or future treaty against double taxation which may apply to payments made to Vactech under this Agreement.

 

5.4
Audits. Provention shall keep (and shall cause its Affiliates and Sublicensees to keep) complete and accurate records pertaining
to the sale or other disposition of Products in sufficient detail to permit Vactech to confirm the accuracy of all royalty payments
due hereunder for at least seven (7) full calendar years following the end of the calendar year to which they pertain. Vactech
shall have the right, once annually, to cause an independent, certified public accountant reasonably acceptable to Provention
to audit such records solely to confirm Net Sales and royalties for a period covering not more than the preceding three (3) full
calendar years. No calendar year shall be subject to audit under this section more than once. Such audits may be exercised during
normal business hours upon reasonable prior written notice of not less than sixty (60) days to Provention in the location where
the records are maintained. The auditor will execute a confidentiality agreement in a form acceptable to Provention with Provention
and will disclose to Vactech only such information as is reasonably necessary to provide Vactech with information regarding any
actual or potential discrepancies between amounts reported and actually paid and amounts payable under this Agreement. The auditor
will send a copy of the report to Provention at the same time it is sent to Vactech. The report sent to both Parties will include
the methodology and calculations used to determine the results. Prompt adjustments shall be made by the Parties to reflect the
results of such audit. Vactech shall bear the full cost of such audit unless such audit discloses an underpayment by Provention
of more than five percent (5%) of the amount due for any calendar quarter (a “Material Underpayment”) under
this Agreement, in which case, Provention shall bear the full cost of such audit and shall promptly remit to Vactech the amount
of such Material Underpayment. If either (a) a Material Underpayment is found or (b) an independent auditor determines that there
are insufficient records to support the calculation of the royalty payments due under this Agreement, then Vactech shall have
the right, at its expense, to audit Provention quarterly for the two calendar years succeeding the applicable triggering event.
If any subsequent audit contemplated by the previous sentence reveals a Material Underpayment, the cost of such subsequent audit
shall be borne by Provention. If such audit discloses an overpayment by Provention, then Provention will deduct the amount of
such overpayment from amounts otherwise owed to Vactech under this Agreement.

 

    	 	-23-	 

     

    

 

CONFIDENTIAL

 

Article
6.

CONFIDENTIALITY AND PUBLICATION

 

6.1
Confidential Information. Except to the extent expressly authorized by this Agreement, each Party (in such capacity, the “Receiving
Party”) agrees that, during the Term and for seven (7) years thereafter, it shall keep confidential and shall not
publish or otherwise disclose to any Third Party, and shall not use for any purpose other than as expressly provided for in this
Agreement or any other written agreement between the Parties, any Confidential Information furnished or made available to it by
or on behalf of the other Party (in such capacity, the “Disclosing Party”). The Receiving Party shall
use at least the same standard of care as it uses to protect proprietary or confidential information of its own (but in no event
less than reasonable care) to ensure that it, and its and its Affiliates’, employees, agents, consultants and other representatives
do not disclose or make any unauthorized use of the Confidential Information. The Receiving Party shall promptly notify the Disclosing
Party upon discovery of any unauthorized use or disclosure of the Disclosing Party’s Confidential Information. The Vactech
Technology, to the extent subject to the licenses to Provention under this Agreement, shall be deemed the Confidential Information
of Provention notwithstanding the fact that it was furnished by Vactech to Provention in the first instance.

 

6.2
Exceptions. Confidential Information shall not include any information which the Receiving Party can prove by competent evidence:
(a) is now, or hereafter becomes, through no act or failure to act on the part of the Receiving Party, generally known or available;
(b) is known by the Receiving Party and/or any of its Affiliates at the time of receiving such information, as evidenced by its
records; (c) is hereafter furnished to the Receiving Party and/or any of its Affiliates by a Third Party, as a matter of right
and without restriction on disclosure; or (d) is independently discovered or developed by the Receiving Party and/or any of its
Affiliates, without the use of Confidential Information of the Disclosing Party. Any combination of features or disclosures shall
not be deemed to fall within the exclusions set forth in the preceding clauses (a) and (b) merely because individual features
are published or available to the general public or in the rightful possession of the Receiving Party unless the combination itself
and principle of operation are published or available to the general public or in the rightful possession of the Receiving Party.

 

6.3
Authorized Disclosure. Notwithstanding the provisions of Section 6.1, the Receiving Party may disclose Confidential Information
of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary
in the following instances:

 

(a)
filing or prosecuting Patents as permitted by this Agreement;

 

(b)
enforcing such Party’s rights under this Agreement (including registering the licenses granted hereunder with applicable
authorities) and in performing its obligations under this Agreement.

 

    	 	-24-	 

     

    

 

CONFIDENTIAL

 

(c)
prosecuting or defending litigation as permitted by this Agreement;

 

(d)
complying with applicable court orders, applicable laws, rules or regulations, or the listing rules of any exchange on which
the Receiving Party’s securities are traded;

 

(e)
disclosure to Affiliates, actual and potential licensees and sublicensees, employees, consultants or agents of the Receiving
Party who have a need to know such information in order for the Receiving Party to exercise its rights or fulfill its obligations
under this Agreement, provided, in each case, that any such Affiliate, actual or potential licensee or sublicensee, employee,
consultant or agent agrees to be bound by terms of confidentiality and non-use comparable in scope to those set forth in this
Article 6; and

 

(f)
disclosure to Third Parties in connection with due diligence or similar investigations by such Third Parties, and disclosure
to potential Third Party investors or acquirers in confidential financing documents, provided, in each case, that any such Third
Party agrees to be bound by reasonable obligations of confidentiality and non-use.

 

Notwithstanding
the foregoing, in the event the Receiving Party is required to make a disclosure of the Disclosing Party’s Confidential
Information pursuant to Section 6.3(c) or 6.3(d), it will, except where impracticable, give reasonable advance notice to the Disclosing
Party of such disclosure and use efforts to secure confidential treatment of such information at least as diligent as the Receiving
Party would use to protect its own confidential information, but in no event less than reasonable efforts. In any event, the Receiving
Party agrees to take all reasonable action to avoid disclosure of Confidential Information hereunder.

 

6.4
Publications. Provention and its Affiliates shall have the right to publish the results of their development activities, including
clinical trials, with respect to the Products in the Field. Vactech shall have the right to review and comment on any material
proposed for disclosure or publication by Provention or its Affiliate, such as by oral presentation, manuscript or abstract that
includes Confidential Information of Vactech. Before any such material is submitted for publication or disclosure (other than
oral presentation materials and abstracts, which are addressed below), Provention shall deliver a complete copy to Vactech at
least 30 days prior to submitting the material to a publisher or initiating such other disclosure, and Vactech shall review any
such material and give its comments to Provention within 10 days of the delivery of such material to Vactech which comments shall
be considered by Provention in good faith. With respect to oral presentation materials and abstracts, Provention shall deliver
a complete copy to Vactech at least 10 business days prior to the anticipated date of the presentation, and Vactech shall make
reasonable efforts to expedite review of such materials and abstracts, and shall return such items as soon as practicable to Provention
with appropriate comments, if any, but in no event later than 5 business days from the date of delivery to Vactech which comments
shall be considered by Provention in good faith. Provention shall comply, or cause its Affiliate to comply (as applicable), with
Vactech’s requests to delete references to Vactech’s Confidential Information in any such material and, if applicable,
agrees to delay any submission for publication or other public disclosure for a period of up to an additional 60 days for the
purpose of preparing and filing appropriate patent applications. Vactech shall not publish or otherwise disseminate, including,
but not limited to, in articles, posters, oral presentations or other formats, any information relating to Candidates and/or Products
without the prior written consent of Provention.

 

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CONFIDENTIAL

 

6.5
Publicity.

 

(a)
Press Releases. The Parties shall jointly issue a press release acceptable to each Party to be released at an agreed upon
time. Except as required by the applicable securities laws or the listing rules of any stock exchange on which securities issued
by a Party or its Affiliates are traded, neither Party shall make any other public announcement concerning this Agreement or the
subject matter hereof without the prior written consent of the other, which shall not be unreasonably withheld or delayed; provided
that each Party may make any public statement in response to questions by the press, analysts, investors or those attending industry
conferences or financial analyst calls, respond to queries by any exchange on which such Party’s securities are traded,
or issue press releases, so long as any such public statement, response, or press release is not inconsistent with prior public
disclosures or public statements made in accordance with this Section 6.5 and which do not reveal non-public information about
the other Party. In the event of a required public announcement, to the extent practicable under the circumstances, the Party
making such announcement shall use reasonable efforts to provide the other Party with a copy of the proposed text of such announcement
sufficiently in advance of the scheduled release to afford such other Party a reasonable opportunity to review and comment upon
the proposed text, unless the proposed text is substantially the same as that used in any prior public disclosure, press release
or public statement made in accordance with this Section 6.5.

 

(b)
Filing of this Agreement. The Parties shall coordinate in advance with each other in connection with the filing of this Agreement
(including redaction of certain provisions of this Agreement) with any securities authority or with any stock exchange on which
securities issued by a Party or its Affiliate are traded, and each Party will use reasonable efforts to seek confidential treatment
for the terms proposed to be redacted; provided that each Party will ultimately retain control over what information to disclose
to any securities authority or stock exchange, as the case may be, and provided further that the Parties will use their reasonable
efforts to file redacted versions with any governing bodies which are consistent with redacted versions previously filed with
any other governing bodies. Other than such obligation, neither Party (nor any of its Affiliates) will be obligated to consult
with or obtain approval from the other Party with respect to any filings to any securities authority or stock exchange. Vactech
hereby consents to Provention’s use of its name in any filing with a Regulatory Authority as well as any private placement
memorandum or other investment document related to Provention or its securities; provided that, Vactech shall be afforded a reasonable
opportunity to review any such filing of investment document and any comments provided by Vactech to Provention with respect to
the use of its name in such filing or investment document shall be considered in good faith by Provention.

 

    	 	-26-	 

     

    

 

CONFIDENTIAL

 

6.6
Prior Confidential Disclosure Agreement. As of the Effective Date, the terms of this Article 6 shall supersede any prior non-disclosure,
secrecy or confidentiality agreement between the Parties (or their Affiliates) dealing with the subject of this Agreement, including
the Confidential Disclosure Agreement between Vactech and Creative BioVentures Corp. dated February 1st, 2016. Any
information disclosed by a Party pursuant to any such prior agreement shall be deemed Confidential Information of such Party for
purposes of this Agreement. As of the Effective Date, Creative BioVentures will confirm its agreement to the foregoing by separate
letter.

 

6.7
Notifications. Provention shall promptly notify Vactech in the event that it receives a credible offer from a Third Party
to (a) acquire Provention, Product or Product development program in a Sale Transaction or (b) sub-license a Product. Any notice
provided to Vactech with respect to (a) or (b) of the previous sentence shall be deemed Confidential Information of Provention
subject to this Article 6.

 

Article
7.

REPRESENTATIONS AND WARRANTIES; CERTAIN COVENANTS

 

7.1
Mutual Representations and Warranties. Each Party represents and warrants to the other that, as of the Effective Date: (a)
it is duly organized and validly existing under the laws of its jurisdiction of incorporation or formation, and has full corporate
or other power and authority to enter into this Agreement and to carry out the provisions hereof; (b) it is duly authorized to
execute and deliver this Agreement and to perform its obligations hereunder, and the person or persons executing this Agreement
on its behalf has been duly authorized to do so by all requisite corporate or partnership action; and (c) this Agreement is legally
binding upon it, enforceable in accordance with its terms, and does not conflict with any agreement, instrument or understanding,
oral or written, to which it is a party or by which it may be bound, nor violate any material law or regulation of any court,
governmental body or administrative or other agency having jurisdiction over it.

 

7.2
Vactech Representations and Warranties. Vactech represents and warrants to Provention that as of the Effective Date of this
Agreement:

 

(a)
Exhibit A attached hereto contains a true and complete list of the Vactech Patent Rights existing on the Effective Date. The
Vactech Patent Rights listed in Exhibit A include all of the Patent Rights Controlled by Vactech as of the Effective Date
that Cover CBV or the Virus-Like Particle Technology, or the manufacture, use, sale, offer for sale or import of the foregoing;

 

(b)
Vactech (i) has the right to grant the licenses that it purports to grant in Section 2.1 (including, without limitation, that
Vactech has not entered into any undertaking that limits, nor is subjected to any constraints that limit, its rights or freedom
to grant the licenses); and (ii) has not granted to any Third Party any license or other right with respect to CBV, the Virus-Like
Particle Technology, a Product or Vactech Technology that conflicts with the license and rights granted to Provention herein;

 

    	 	-27-	 

     

    

 

CONFIDENTIAL

 

(c)
there are no agreements in effect as of the Effective Date between Vactech and a Third Party under which rights with respect
to the Vactech Technology are being licensed to Vactech;

 

(d)
no Third Party (including, but not limited to any governmental authority) has any rights in or to CBV, the Virus-Like Particle
Technology, a Product or any Vactech Technology for any reason, including, but not limited to as a result of development work
performed by such Third Party or funding provided by such Third Party;

 

(e)
the issued and unexpired claims included in the Vactech Patent Rights existing as of the Effective Date are valid and enforceable;

 

(f)
no reexamination, interference, invalidity, opposition, nullity or similar claim or proceeding is pending or threatened with
respect to any Vactech Patent Right;

 

(g)
to Vactech’s knowledge, the manufacture (using any manufacturing process used by or on behalf of Vactech on or before
the Effective Date), use, sale, offer for sale or import of CBV, Virus-Like Particle Technology or any Vactech Technology does
not Infringe any issued patent, and Vactech has not received written notice from any Third Party claiming that the manufacture,
use, sale, offer for sale or import of CBV, Virus-Like Particle Technology or any Product Infringes or would Infringe the patent
or other intellectual property rights of any Third Party; if Vactech receives any such written notice during the term of this
Agreement, Vactech shall promptly provide such written notice to Provention;

 

(h)
there are no claims, judgments or settlements against or owed by Vactech (or any of its Affiliates) with respect to the Vactech
Technology, and Vactech is not a party to any legal action, suit or proceeding relating to the Vactech Technology, CBV, Virus-Like
Particle Technology or any Product, nor has Vactech received any written communication from any Third Party, including, without
limitation, any Regulatory Authority or other government agency, threatening such action, suit or proceeding;

 

(i)
all tangible or recorded information and data provided by or on behalf of Vactech to Provention related to CBV, Virus-Like
Particle Technology or any Product on or before the Effective Date in contemplation of this Agreement was and is true, accurate
and complete in all material respects, and Vactech has not failed to disclose, or failed to cause to be disclosed, any such information
or data related to CBV, Virus-Like Particle Technology or any Product in its possession and Control that would cause the information
and data that has been disclosed to be misleading in any material respect;

 

(j)
neither Vactech nor any of its Affiliates has obtained, or filed for, any INDs, NDAs or Marketing Approvals for any Product,
and, to the best of Vactech’s knowledge, no other Person has obtained, or filed for, any INDs, NDAs or Marketing Approvals
for any Product in the Field in the Territory;

 

    	 	-28-	 

     

    

 

CONFIDENTIAL

 

(k)
at the time of delivery to Provention, any reference samples delivered to Provention will be free and clear of any liens or
encumbrances;

 

(l)
there are no ongoing research or development activities (including any clinical trials) being conducted by or on behalf of
Vactech or any of its Affiliates with respect to CBV or Virus-Like Particle Technology related to Candidates or Products in the
Field in the Territory;

 

(m)
(i) all research and development (including non-clinical studies and clinical trials) conducted by or on behalf of Vactech
or any of its Affiliates related to the CBV, the Virus-Like Particle Technology and/or Products prior to the Effective Date was
conducted in compliance in all material respects with all Applicable Laws and, as applicable, GLP, GCP and/or GMP; and (ii) to
Vactech’s knowledge, all research and development (including non-clinical studies and clinical trials) conducted related
to CBV, the Virus-Like Particle Technology and/or Products prior to the Effective Date was conducted in compliance in all material
respects with all Applicable Laws and, as applicable, GLP, GCP and/or GMP;

 

(n)
neither Vactech nor any of its Affiliates is debarred or disqualified under the Act or comparable Applicable Laws outside
of the United States;

 

(o)
neither Vactech nor any of its Affiliates has employed or otherwise used in any capacity, in connection with the development
or manufacture of CBV, the Virus-Like Particle Technology or Product, the services of any Person debarred or disqualified under
United States law, including 21 U.S.C. §335a, or any foreign equivalent thereof;

 

(p)
Vactech and, to the best of its knowledge, its directors, officers, employees, and any agent, representative, subcontractor
or other third party acting for or on such its behalf, has not, directly or indirectly, offered, paid, promised to pay, or authorized
such offer, promise or payment, of anything of value, to any Person for the purposes of obtaining or retaining business through
any improper advantage in connection with the development, commercialization or exploitation of a Product, or that would otherwise
violate any applicable Laws, rules and regulations concerning or relating to public or commercial bribery or corruption, and Vactech’s
books, accounts, records and invoices related to the Product are complete and accurate; and

 

(q)
Vactech has not violated the FCPA or Export Control Laws in connection with the development of CBV or the Virus-Like Particle
Technology.

 

7.3
Vactech Covenants. In addition to any covenants made by Vactech elsewhere in this Agreement, Vactech hereby covenants to Provention
that during the Term, Vactech will (i) not grant any Third Party any license or other right with respect to CBV, the Virus-Like
Particle Technology, any Product or Vactech Technology in derogation of the license and rights granted to Provention hereunder,
and (ii) disclose any and all additional Vactech Technology developed or Controlled by Vactech after the Effective Date;

 

    	 	-29-	 

     

    

 

CONFIDENTIAL

 

7.4
Provention Representations and Warranties. Provention represents and warrants to Vactech that as of the Effective Date of
this Agreement neither Provention nor any of its Affiliates is debarred or disqualified under the Act or comparable Applicable
Laws outside the United States.

 

7.5
Mutual Covenants. In addition to any covenants made by a Party elsewhere in this Agreement, each Party hereby covenants to
the other as follows:

 

(a)
neither such Party nor any of its Affiliates will employ or use the services of any Person who is debarred or disqualified
under United States law, including 21 U.S.C. §335a, or any foreign equivalent thereof, in connection with activities relating
to any Product; and in the event that such Party becomes aware of the debarment or disqualification or threatened debarment or
disqualification of any Person providing services to such Party or any of its Affiliates with respect to any activities relating
to any Product, such Party will immediately notify the other Party in writing and such Party will cease, or cause its Affiliate
to cease (as applicable), employing, contracting with, or retaining any such Person to perform any services relating to any Product;

 

(b)
neither such Party nor any of its Affiliates will, in connection with the exercise of its rights or performance of its obligations
under this Agreement, directly or indirectly through Third Parties, pay, promise or offer to pay, or authorize the payment of,
any money or give any promise or offer to give, or authorize the giving of anything of value to a public official or entity or
other Person for purpose of obtaining or retaining business for or with, or directing business to, any Person, including such
Party and its Affiliates, nor will such Party or any of its Affiliates directly or indirectly promise, offer or provide any corrupt
payment, gratuity, emolument, bribe, kickback, illicit gift or hospitality or other illegal or unethical benefit to a public official
or entity or any other Person in connection with the exercise of such Party’s rights or performance of such Party’s
obligations under this Agreement; and

 

(c)
neither such Party nor any of its Affiliates (or any of their respective employees and contractors), in connection with the
exercise of such Party’s rights or performance of such Party’s obligations under this Agreement, shall cause the other
Party to be in violation of the FCPA or Export Control Laws.

 

7.6
Performance by Affiliates, Sublicensees and Subcontractors. The Parties recognize that each Party may perform some or all
of its obligations or exercise some or all of its rights under this Agreement through one or more Affiliates, subcontractors,
or, in the case of Provention, Sublicensees; provided, in each case, that (a) none of the other Party’s rights hereunder
are diminished or otherwise adversely affected as a result of such delegation or subcontracting, and (b) each such Affiliate,
subcontractor or Sublicensee undertakes in writing obligations of confidentiality and non-use regarding Confidential Information
and ownership of Inventions which are substantially the same as those undertaken by the Parties pursuant to Article 6 and Section
8.1; and provided, further, that such Party shall at all times be fully responsible for the performance and payment of
such Affiliate, subcontractor or Sublicensee.

 

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CONFIDENTIAL

 

7.7
Limitation of Liability. EXCEPT FOR LIABILITY FOR BREACH OF ARTICLE 6 OR IN THE CASE OF FRAUD, GROSS NEGLIGENCE OR INTENTIONAL
MISCONDUCT, NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE
DAMAGES IN CONNECTION WITH THIS AGREEMENT OR ANY LICENSE GRANTED HEREUNDER; provided, however, that this Section 7.7 shall
not be construed to limit either Party’s indemnification obligations under Article 10.

 

Article
8.

INTELLECTUAL PROPERTY

 

8.1
Ownership. As between the Parties, Vactech is and shall at all times be the sole and exclusive owner of all right, title and
interest in and to the Vactech Technology, other than Joint Inventions and Joint Patent Rights, and Provention is and shall at
all times be the sole and exclusive owner of all right, title and interest in and to the Provention Technology, other than Joint
Inventions and Joint Patent Rights. A Party shall have and retain all right, title and interest in any Invention made solely by
one or more employees or agents of such Party and or its Affiliates or other persons acting under its authority. The Parties shall
jointly own rights in any Invention made jointly by one or more employees or agents of each Party and/or such Party’s Affiliates
or other persons acting under its authority (“Joint Inventions”) and Patent Rights therein (“Joint
Patent Rights”). For clarity, Inventions developed exclusively by one Party and such Party’s Affiliates shall
not be considered Joint Inventions. Subject to the rights and licenses granted under this Agreement, each Party shall have the
right to practice and use, and grant licenses to practice and use, any Joint Inventions and Joint Patent Rights without the other
Party’s consent and has no duty to account to the other Party for such practice, use or license, and each Party hereby waives
any right it may have under the laws of any country to require any such consent or accounting. Each Party shall be liable with
respect to its own employees for compliance with any applicable legislation and its own policies concerning employee inventions,
including payment of employee invention awards (if any).

 

8.2
Patent Prosecution and Maintenance.

 

(a)
Vactech Patent Rights. From and after the end of the Transition Period, subject to Section 8.2(b) and the last sentence of
this Section 8.2(a), Provention shall have the sole right, but not the obligation, to control the preparation, filing, prosecution
and maintenance of Vactech Patent Rights at Provention’s sole expense and by counsel of its choice. Provention shall keep
Vactech reasonably informed of progress with regard to the preparation, filing, prosecution and maintenance of such Vactech Patent
Rights and shall provide to Vactech copies of all material patent office submissions within a reasonable amount of time following
submission thereof by Provention. In the event that Provention desires to abandon or cease prosecution or maintenance of any Vactech
Patent Right in any country or jurisdiction (such country or jurisdiction, the “Abandoned Territory”), Provention
shall provide written notice to Vactech of such intention to abandon no later than seventy (70) days prior to the next deadline
for any action that must be taken with respect to such Vactech Patent Right in the relevant patent office. In such case, upon
receipt of a written request by Vactech to assume responsibility for prosecution and maintenance of such, Vactech Patent Right,
Provention shall allow Vactech at its sole cost and expense and by counsel of its own choice, delivered no later than thirty (30)
days after receipt of notice from Vactech to assume such responsibility and Provention shall be deemed to have terminated this
Agreement pursuant to Section 9.4 in the Abandoned Territory; provided, however, that this Agreement shall not be deemed to have
been terminated pursuant to Section 9.4 and this Section 8.2(a) in the event Provention elects, in good faith, to abandon or cease
prosecution or maintenance of a particular Vactech Patent Right for strategic or commercially reasonable reasons and where other
Vactech Technology is being exploited in connection with the development, manufacturing or commercialization of a Licensed Product
in such country.

 

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CONFIDENTIAL

 

(b)
Vactech Step-In Right. In the event that Provention has undertaken to prosecute or maintain a Vactech Patent Right as provided
in Section 8.2(a) and Vactech reasonably determines that Provention is not diligently pursuing the maintenance and/or prosecution
of such Vactech Patent Right, then Vactech shall provide written notice to Provention indicating that in its reasonable determination,
Provention has not met its obligations under Section 8.2(a) with respect to the subject Vactech Patent Right. The parties shall
then engage in good faith discussions regarding the prosecution and/or maintenance of the subject Vactech Patent Right for a period
of not more than thirty (30) days in an attempt to resolve Vactech’s concerns. If an agreement is reached between the parties
with respect to the ongoing prosecution and maintenance of the subject Vactech Patent Right, Provention shall be afforded a period
of ninety (90) days to implement the agreed upon prosecution and/or maintenance plan. In the event that no agreement is reached
and/or Provention fails to implement the agreed upon plan and Provention’s prosecution and/or maintenance of the subject
Vactech Patent is determined to be materially deficient, Vactech shall have the option, but not the obligation, to take over the
prosecution and/or maintenance of the subject Vactech Patent Right.

 

(c)
Joint Patent Rights. Provention shall have the first right, but not the obligation, to prepare, file, prosecute and maintain
all Joint Patent Rights, at Provention’s sole expense and by counsel of its choice. Provention shall keep Vactech reasonably
informed of progress with regard to the preparation, filing, prosecution and maintenance of the Joint Patent Rights, and shall
provide to Vactech copies of all material patent office submissions within a reasonable amount of time following submission thereof
by Provention. In the event that Provention desires to abandon or cease prosecution or maintenance of any Joint Patent Right,
Provention shall provide written notice to Vactech of such intention to abandon promptly after Provention makes such determination,
which notice shall be given no later than seventy (70) days prior to the next deadline for any action that must be taken with
respect to such Joint Patent Right in the relevant patent office. In such case, Vactech shall have the right, in its discretion,
exercisable upon written notice to Provention delivered no later than thirty (30) days after receipt of notice from Provention,
to assume responsibility for prosecution and maintenance of such Joint Patent Right, at its sole cost and expense and by counsel
of its own choice, and if Vactech exercises such right, then Provention shall cease to have any rights to such Joint Patent Right;
provided that such Joint Patent Right shall be deemed to be a Vactech Patent Right and therefore subject to this Agreement.

 

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CONFIDENTIAL

 

(d)
Provention Patent Rights. Except as provided in Section 8.2(c), Provention shall have the sole right, but not the obligation,
to control the preparation, filing, prosecution and maintenance of Provention Patent Rights at Provention’s sole expense
and by counsel of its choice.

 

(e)
Cooperation of the Parties. Each Party agrees to cooperate fully in the preparation, filing, prosecution and maintenance of
Patent Rights under this Agreement and in the obtaining and maintenance of any patent term extensions, supplementary protection
certificates and the like with respect to any Patent Right as well as in registering the licenses granted hereunder with the applicable
authorities. Such cooperation includes, but is not limited to: (i) executing all papers and instruments, or requiring its employees
or contractors to execute such papers and instruments, so as to effectuate the joint ownership of Joint Inventions and Joint Patent
Rights set forth in Section 8.1, and to enable the other Party to apply for and to prosecute patent applications in any country
in accordance with the foregoing provisions of this Section 8.2; and (ii) promptly informing the other Party of any matters coming
to such Party’s attention that may affect the preparation, filing, prosecution or maintenance of any such patent applications.

 

8.3
Interference, Opposition, Invalidation, Reexamination and Reissue.

 

(a)
Relevant Vactech Patent Claims.

 

(i)
Provention First Right. Vactech shall, within 10 days of learning of such event, inform Provention of any request for, or
filing or declaration of, any interference, opposition, invalidation, reissue, reexamination or post grant review relating to
claims of the Vactech Patent Rights that cover any Product in the Field or their use in the development or manufacture of any
Product in the Field (the “Relevant Vactech Patent Claims”). With respect to any request for, or filing
or declaration of, any interference, opposition, invalidation, reissue or reexamination relating to Relevant Vactech Patent Claims,
Provention shall have the first right (in its discretion) to initiate, prosecute and/or respond, to such action or proceeding,
provided that Provention shall consult with Vactech with respect to any such action or proceeding and shall consider Vactech’s
position in good faith. In the event that Provention elects to initiate, prosecute and/or respond to any interference, opposition,
invalidation, reexamination, reissue or post grant review proceeding relating to any Relevant Vactech Patent Claim, the expenses
thereof shall be borne solely by Provention. Provention shall keep Vactech informed of developments in any such action or proceeding
involving any Relevant Vactech Patent Claim. Further such Relevant Vactech Patent Claim shall thereafter be deemed to be a Vactech
Patent Right and therefore subject to this Agreement.

 

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(ii)
Vactech Back-Up Right. Provention shall promptly inform Vactech in the event that Provention elects not to initiate, prosecute
and/or respond to any interference, opposition, invalidation, reissue, reexamination or post grant review relating to any Relevant
Vactech Patent Claim, and in such case, Vactech shall have the right to do so (in Vactech’s discretion), at its cost and
expense within ninety (90) days of receiving notice from Provention of its election not to prosecute and/or respond. Vactech shall
not settle any interference, opposition, invalidation, reissue, reexamination or post grant review action or proceeding relating
to any Relevant Vactech Patent Claim without the prior written consent of Provention, which consent shall not be unreasonably
withheld. Vactech shall keep Provention informed of developments in any such action or proceeding involving any Relevant Vactech
Patent Claim.

 

(b)
Joint Patent Rights. Each Party shall, within ten (10) days of learning of such event, inform the other Party of any request
for, or filing or declaration of, any interference, opposition, invalidation, reissue, reexamination or post grant review relating
to Joint Patent Rights.

 

(i)
Relevant Joint Patent Claims.

 

(1)
Provention First Right. With respect to any request for, or filing or declaration of, any interference, opposition, invalidation,
reissue, reexamination or post grant review relating to claims of the Joint Patent Rights that cover a Product in the Field or
its use or manufacture (the “Relevant Joint Patent Claims”), Provention shall have the first right (in
its discretion) to initiate, prosecute and/or respond, to such action or proceeding, provided that Provention shall consult with
Vactech with respect to any such action or proceeding and shall consider Vactech’s position in good faith. In the event
that Provention elects to initiate, prosecute and/or respond to any interference, opposition, invalidation, reexamination, reissue
or post grant review proceeding relating to any Relevant Joint Patent Claim, the expenses thereof shall be borne solely by Provention.
Provention shall not settle any interference, opposition, invalidation, reissue, reexamination or post grant review action or
proceeding relating to any Relevant Joint Patent Claim without the prior written consent of Vactech, which consent shall not be
unreasonably withheld. Provention shall keep Vactech informed of developments in any such action or proceeding involving any Relevant
Joint Patent Claim. Further such Joint Patent Claim shall thereafter be deemed to be a Vactech Technology and therefore subject
to this Agreement.

 

(2)
Vactech Back-Up Right. Provention shall promptly inform Vactech in the event that Provention elects not to initiate, prosecute
and/or respond to any interference, opposition, invalidation, reissue, reexamination or post grant review relating to any Relevant
Joint Patent Claim, and in such case, Vactech shall have the right to do so (in Vactech’s discretion), at its cost and expense.
Vactech shall not settle any interference, opposition, invalidation, reissue, reexamination or post grant review action or proceeding
relating to any Relevant Joint Patent Claim without the prior written consent of Provention, which consent shall not be unreasonably
withheld. Vactech shall keep Provention informed of developments in any such action or proceeding involving any Relevant Joint
Patent Claim.

 

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CONFIDENTIAL

 

(ii)
Other Joint Patent Claims. The Parties shall mutually agree on a case-by-case basis which Party will have the right to handle
any interference, opposition, invalidation, reissue, reexamination or post grant review proceeding relating to claims of the Joint
Patent Rights that are not Relevant Joint Patent Claims (“Other Joint Patent Claims”)
and how the expenses of such action or proceeding will be allocated. Neither Party shall settle any interference, opposition,
invalidation, reissue, reexamination or post grant review action or proceeding relating to any Other Joint Patent Claim without
the prior written consent of the other Party, which consent shall not be unreasonably withheld. The Party handling such action
or proceeding shall keep the other Party informed of developments in any such action or proceeding involving any Other Joint Patent
Claim.

 

(c)
Provention Patent Rights. Except as provided in Section 8.3(b), Provention shall have the sole right, in its discretion, to
handle any interference, opposition, invalidation, reissue, reexamination or post grant review proceeding relating to Provention
Patent Rights, and Vactech shall have no rights in connection therewith.

 

8.4
Enforcement and Defense of Patent Rights. Each Party shall notify the other Party in writing within 10 Business Days (except
as expressly set forth below) of becoming aware of any alleged or threatened infringement by a Third Party of any of the Vactech
Patent Rights, Joint Patent Rights or Provention Patent Rights (“Infringement”), including (x) any such
alleged or threatened Infringement on account of a Third Party’s manufacture, use or sale of a Product in the Field, (y)
any certification filed in the United States under 21 U.S.C. §355(b)(2) or 21 U.S.C. §355(j)(2) or similar provisions
in other jurisdictions in connection with an ANDA (an Abbreviated New Drug Application in the United States or a comparable application
for Marketing Approval under Applicable Law in any country other than the United States) or other NDA for a Product in the Field
(a “Patent Certification”), and (z) any declaratory judgment action filed by a Third Party that is developing,
manufacturing or commercializing a Product in the Field alleging the invalidity, unenforceability or non-infringement of any of
the Vactech Patent Rights, Joint Patent Rights or Provention Patent Rights ((x)-(z), collectively, “Competitive Infringement”);
provided, however, that each Party shall notify the other Party of any Patent Certification regarding any Vactech Patent
Right or Joint Patent Right that it receives, and such Party shall provide the other Party with a copy of such Patent Certification,
within five (5) days of receipt.

 

(a)
Competitive Infringement. Provention shall have the first right, but not the obligation, to bring (or defend) and control
any action or proceeding with respect to Competitive Infringement of a Vactech Patent Right or a Joint Patent Right, in each case
that covers a Product (collectively, the “Relevant Patent Rights”), at Provention’s own expense
and by counsel of its own choice. If Provention fails to bring any such action or proceeding with respect to Competitive Infringement
of any Relevant Patent Right within ninety (90) days following the notice of alleged Competitive Infringement, Vactech shall have
the right to bring (or defend) and control any such action at its own expense and by counsel of its own choice, and Provention
shall have the right, at its own expense, to be represented in any such action by counsel of its own choice.

 

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(b)
Other Infringement. The Parties shall mutually agree on a case-by-case basis (A) whether to bring (or defend) and control
any action or proceeding with respect to Competitive Infringement of any Patent Right that is not a Relevant Patent Right, (B)
which Party would bring (or defend) and control such action, and (C) how the expenses of, and any recovery from, any such action
would be allocated.

 

(c)
Provention Patent Rights. Except as provided in Section 8.4(a), Provention shall have the sole right, but not the obligation,
to bring (or defend) and control any action or proceeding with respect to infringement of any Provention Patent Right at its own
expense and by counsel of its own choice.

 

(d)
Cooperation. In the event a Party brings (or defends) an Infringement action in accordance with this Section 8.4, or in the
event a Party is entitled to bring (or defend) an infringement action in accordance with this Section 8.4 but lacks standing to
do so, the other Party shall cooperate fully, including, if required to bring (or defend) such action, the furnishing of a power
of attorney or being named as a party. Neither Party shall enter into any settlement or compromise of any action under this Section
8.4 which would in any manner alter, diminish, or be in derogation of the other Party’s rights under this Agreement without
the prior written consent of such other Party, which shall not be unreasonably withheld.

 

(e)
Recovery. Except as otherwise agreed by the Parties in connection with a cost-sharing arrangement, any recovery realized by
a Party as a result of any action or proceeding pursuant to this Section 8.4, whether by way of settlement or otherwise, shall
be applied first to reimburse the documented out-of-pocket legal expenses of the Party that brought (or defended) and controlled
such action or proceeding incurred in connection with such action or proceeding, and second to reimburse the documented out-of-pocket
legal expenses of the other Party incurred in connection with such action or proceeding, and any remaining amounts shall be retained
by the Party that brought (or defended) and controlled such action; provided, however, that:

 

(i)
any recovery realized by Provention as a result of any action brought (or defended) and controlled by Provention pursuant
to Section 8.4(a) or Section 8.4(b) (after reimbursement of the Parties’ documented out-of-pocket legal expenses relating
to the action or proceeding) shall be allocated as follows:

 

(1)
compensatory damages shall, if awarded, be treated as Net Sales of Products in the quarter in which such damages are received
for purposes of Section 4.3; and

 

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CONFIDENTIAL

 

(2)
non-compensatory damages shall be divided 80% to Provention and 20% to Vactech; and

 

(ii)
any recovery realized by Vactech as a result of any action brought and controlled by Vactech pursuant to Section 8.4(a) or
Section 8.4(b) (after reimbursement of the Parties’ documented out-of-pocket legal expenses relating to the action or proceeding)
shall be allocated as follows:

 

(1)
compensatory damages shall belong solely to Vactech; and

 

(2)
non-compensatory damages shall be shared equally by the Parties.

 

8.5
Patent Term Extensions.

 

(a)
Vactech Patent Rights. Provention shall have the right to determine the Vactech Patent Rights for which it will apply for
extension of patent term in any country and/or region for any Product in the Field. Provention shall file for any such extension
at Provention’s cost and expense. Vactech shall provide all reasonable assistance to Provention in connection with such
filings, provided that Provention shall pay or reimburse any out-of-pocket costs incurred by Vactech in providing such assistance.
In the event that Provention desires to not apply for a patent extension for any such Vactech Patent Rights for which there is
a reasonable basis to file for such extension, Provention shall provide written notice to Vactech of such intention to not file
no later than seventy (70) days prior to the next deadline for any action that must be taken with respect to such Vactech Patent
Right in the relevant patent office. In such case, upon receipt of a written request by Vactech to assume responsibility for prosecution
and maintenance of such, Vactech Patent Right, Provention shall allow Vactech at its sole cost and expense and by counsel of its
own choice, delivered no later than 30 days after receipt of notice from Vactech to assume such responsibility, and following
the successful filing of any such extension, such country or region shall no longer be deemed to be included in the Territory
of this Agreement.

 

(b)
Joint Patent Rights. Provention shall have the right to determine the Joint Patent Rights for which it will apply for patent
term extension in any country and/or region for any Product in the Field, and Provention shall file for any such extension at
Provention’s cost and expense. Each Party shall provide all reasonable assistance to the other Party in connection with
such filings, provided that the Party filing for any such extension shall pay or reimburse any out-of-pocket costs incurred by
the other Party in providing such assistance.

 

(c)
Provention Patent Rights. Except as provided in Section 8.5(b), Provention shall have the sole right to apply for extension
of term for any Provention Patent Right in any country and/or region for any product, including, without limitation, any Product
in the Field, at Provention’s sole cost and expense.

 

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CONFIDENTIAL

 

8.6
Infringement of Third Party Rights. Each Party shall promptly notify the other in writing of any allegation by a Third Party
that the activity of either Party pursuant to this Agreement infringes or may infringe the intellectual property rights of such
Third Party. Neither Party shall have the right to settle any patent infringement litigation under this Section 8.6 in a manner
that diminishes the rights or interests of the other Party without the written consent of such other Party (which shall not be
unreasonably withheld).

 

Article
9.

TERM AND TERMINATION

 

9.1
Term. The term of this Agreement shall commence on the Effective Date and, unless earlier terminated in accordance with this
Article 9, continue until the expiration of the last-to-expire of all royalty payment obligations of Provention hereunder (the
“Term”).

 

9.2
Termination for Material Breach.

 

(a)
Each Party shall have the right to terminate this Agreement in its entirety upon written notice to the other Party if such
other Party is in material breach of this Agreement and has not cured such breach within ninety (90) days after notice from the
terminating Party indicating the nature of such breach, or if such other Party is dissolved or liquidated or takes any corporate
action for such purpose; makes a general assignment for the benefit of creditors; or has a receiver, trustee, custodian or similar
agent appointed by order of any court of competent jurisdiction to take charge of or sell any material portion of its property
or business. Any such termination shall become effective at the end of such ninety (90) day period unless the breaching Party
has cured such breach prior to the end of such period. Any right to terminate under this Section 9.2(a) shall be stayed and the
cure period tolled in the event that, during any cure period, the Party alleged to have been in material breach shall have initiated
dispute resolution in accordance with Article 11 with respect to the alleged breach, which stay and tolling shall continue until
such dispute has been resolved in accordance with Article 11.

 

(b)
For clarity, in the event of material breach of this Agreement by Vactech that is not cured within the applicable notice period
set forth in Section 9.2(a), Provention, at its sole discretion, may either:

 

(i)
terminate this Agreement in accordance with Section 9.2(a) (in addition to pursuing any remedy that may be available to Provention
at law or in equity as a result of Vactech’s breach of this Agreement); or

 

(ii)
elect (A) not to terminate this Agreement, (B) to retain the license granted under Section 2.1, subject to all terms and conditions
hereof, and (C) pursue any remedy that may be available to Provention at law or in equity as a result of Vactech’s breach
of this Agreement, without prejudice to Provention’s right to terminate this Agreement at a later date pursuant to Section
9.2 (for that uncured material breach or any other uncured material breach of this Agreement by Vactech) or pursuant to Section
9.4.

 

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9.3
Termination for Patent Challenge. Vactech shall have the right to terminate this Agreement immediately upon written notice
to Provention if Provention or its Affiliate directly, or through assistance granted to a Third Party, commences any interference
or opposition proceeding with respect to, challenges the validity or enforceability of, or opposes any extension of term or the
grant of a supplementary protection certificate with respect to, any Vactech Patent Right.

 

9.4
At-Will Termination by Provention. Provention shall have the right to terminate this Agreement on a country by country basis
for any reason or for no reason at any time upon sixty (60) days’ prior written notice to Vactech, provided Provention’s
termination shall not be deemed to cure any breach existing as of the date of such termination. In the event that Provention terminates
this Agreement (a) in two (2) or more countries in the European Market, this Agreement shall be deemed terminated throughout the
European Union countries as of the date of this Agreement, or (b) in the United States, this Agreement shall be deemed terminated
throughout North America.

 

9.5
Effect of Expiration or Termination.

 

(a)
Expiration. Upon expiration (but not on earlier termination) of this Agreement, all licenses granted by Vactech to Provention
that were in effect immediately prior to such expiration shall survive on a non-exclusive, fully-paid, royalty-free basis.

 

(b)
Any Termination. Upon any termination of this Agreement prior to its expiration, the license (on a country by country basis
in the event of partial termination by Provention under Section 9.4) granted to Provention pursuant to Section 2.1 shall automatically
terminate and revert to Vactech, and all other rights and obligations of the Parties under this Agreement shall terminate, except
as expressly provided below in this Section 9.5 or elsewhere in this Article 9.

 

(c)
Termination by Vactech Pursuant to Section 9.2 or 9.3. Solely in the event of termination of this Agreement by Vactech pursuant
to Section 9.2 or Section 9.3, subject to the negotiation of a commercially reasonable royalty payable from Vactech to Provention,
Provention shall grant Vactech (A) an exclusive (even as to Provention and its Affiliates), royalty-bearing license including
the right to sublicense through multiple tiers of sublicense, under the Provention Patent Rights and (B) a non-exclusive, royalty-bearing
license including the right to sublicense through multiple tiers of sublicense, under the Provention Know-How, in each case, (1)
necessary or useful in connection with the development, manufacture, testing or commercialization of, in the case of (a) a termination
with respect to a specific (or multiple specific) Product(s), the Product(s) for which the license was terminated, and (b) in
the case of a full termination of the license grant from Vactech to Provention, any Candidate or Product that is under active
development or commercialization at the time of such termination and (2) solely to discover, develop, make, have made, use, sell,
have sold, offer for sale, market, export, import and otherwise commercialize the subject Candidate(s) and/or Product(s) in the
market(s) in which the Provention license from Vactech has been terminated.

 

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(d)
Termination by Provention Pursuant to Section 9.4. Solely in the event of termination of this Agreement by Provention pursuant
to Section 9.4, Provention shall, subject to the limitations contained in Section 9.5(c), grant Vactech the licenses and rights
described in Section 9.5(c) above, and in addition, shall transfer to Vactech (1) any IND, NDA, Regulatory Documentation or other
Information, in each case to the extent related to the development, manufacture, testing or commercialization of, in the case
of (a) a termination with respect to a specific (or multiple specific) Product(s), the Product(s) for which the license was terminated
in the market, provided that such limitation shall not apply to the IND, NDA or Regulatory Documentation to be provided but shall
only limit the Product(s) for which such IND, NDA or Regulatory Documentation must be provided, and (b) in the case of a full
termination of the Agreement, any Candidate or Product that is under active development or commercialization at the time of such
termination and (2) the drug master file related to any such Product or Candidate (but only to the extent such drug master file
is owned or Controlled by Provention), as the case may be. Following the transfer described in this Section 9.5(d) and in accordance
with the terms of Article 5 hereof, Vactech shall pay royalties to Provention on aggregate annual Net Sales of all Products in
that portion of the Territory affected by the termination pursuant to Section 9.4 (which could be the entire Territory) by Vactech
and Related Parties in each calendar year at the applicable rate set forth below, as determined based upon the progress made by
Provention prior to terminating the Agreement in accordance with this Section 9.4.

 

	Product
    Progress Achieved	 	 	Royalty
                                         Payment	 
	Completion
    of Phase 3 Clinical Trial for a Product	 	 	[*****	]%
	NDA
    submission related to a Product for any Indication	 	 	[*****	]%
	Commercial
    launch of a Product for any Indication	 	 	[*****	]%

 

For
illustrative purposes, if Provention terminated the Agreement with respect to a particular Product in December of 2017, but prior
to that time Provention had completed a Phase 3 Clinical Trial for such Product, but had not yet submitted an NDA for such Product,
the applicable royalty rate on future Net Sales of such Product would be [*****] percent ([*****]%).

 

9.6
Accrued Obligations; Survival. Neither expiration nor any termination of this Agreement shall relieve either Party of any
obligation or liability accruing prior to such expiration or termination, nor shall expiration or any termination of this Agreement
preclude either Party from pursuing all rights and remedies it may have under this Agreement, at law or in equity, with respect
to breach of this Agreement. In addition, the Parties’ rights and obligations under Sections 6.1, 6.2, 6.3, 6.6, 7.7, 8.1,
8.2(c), 8.3(b), 8.5(b), 9.5, 9.6, 9.7 and 9.8 and Articles 5, 10, 11 and 12 of this Agreement shall survive expiration or any
termination of this Agreement.

 

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9.7
Return of Confidential Information. Within thirty (30) days following the expiration or termination of this Agreement, except
to the extent that a Party retains a license from the other Party as provided in this Article 9, each Party shall promptly return
to the other Party, or delete or destroy, all relevant records and materials in such Party’s possession or control containing
Confidential Information of the other Party; provided that such Party may keep one copy of such materials for archival purposes
only subject to a continuing confidentiality obligations.

 

9.8
Damages; Relief. Termination of this Agreement shall not preclude either Party from claiming any other damages, compensation
or relief that it may be entitled to hereunder.

 

Article
10.

INDEMNIFICATION

 

10.1
Indemnification by Provention. Provention hereby agrees to save, defend, indemnify and hold harmless Vactech, its Affiliates,
its and their respective officers, directors, agents, employees, successors and assigns (the “Vactech Indemnitees”)
from and against any and all losses, damages, liabilities, expenses and costs, including reasonable and documented legal expense
and attorneys’ fees (“Losses”), to which any Vactech Indemnitee may become subject as a result
of any claim, demand, action or other proceeding by any Third Party (each, a “Claim”) to the extent
such Losses arise out of or relate to (a) the gross negligence or willful misconduct of any Provention Indemnitee (defined below),
(b) the breach by Provention of any warranty, representation, covenant or agreement made by Provention in this Agreement, or (c)
the development, manufacture, use, sale, offer for sale or other disposition by or on behalf of Provention or any of its Related
Parties of any Product; except, (i) in each case, to the extent such Losses result from the gross negligence or willful misconduct
of any Vactech Indemnitee or the breach by Vactech of any warranty, representation, covenant or agreement made by Vactech in this
Agreement and (ii) any Claim for which Vactech is obligated to indemnify Provention under Section 10.2.

 

10.2
Indemnification by Vactech. Vactech hereby agrees to save, defend, indemnify and hold harmless Provention, its Affiliates
and their respective officers, directors, employees, consultants and agents (the “Provention Indemnitees”)
from and against any and all Losses to which any Provention Indemnitee may become subject as a result of any claim, demand, action
or other proceeding by any Third Party to the extent such Losses arise out of or relate to (a) the gross negligence or willful
misconduct of any Vactech Indemnitee, (b) (A) actual patent infringement arising out of the exercise of rights under the Vactech
Patent Rights or (B) actual misappropriation of trade secrets arising out of the exercise of rights under the Vactech Know-How
and (c) the breach by Vactech of any warranty, representation, covenant or agreement made by Vactech in this Agreement; in each
case except, (i), in each case, to the extent such Losses result from the gross negligence or willful misconduct of any Provention
Indemnitee or the breach by Provention of any warranty, representation, covenant or agreement made by Provention in this Agreement
and (ii) any Claim for which Provention is obligated to indemnify Vactech under Section 10.1.

 

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10.3
Control of Defense. In the event a Party (the “Indemnified Party”) seeks indemnification under Section
10.1 or 10.2, it shall inform the other Party (the “Indemnifying Party”) of a claim as soon as reasonably
practicable after it receives notice of the claim (it being understood and agreed, however, that the failure by an Indemnified
Party to give notice of a claim as provided in this Section 10.3 shall not relieve the Indemnifying Party of its indemnification
obligation under this Agreement except and only to the extent that such Indemnifying Party is actually damaged as a result of
such failure to give notice), shall permit the Indemnifying Party to assume direction and control of the defense of the claim
(including the right to settle the claim solely for monetary consideration) using counsel reasonably satisfactory to the Indemnified
Party, and shall cooperate as requested (at the expense of the Indemnifying Party) in the defense of the claim. If the Indemnifying
Party does not assume control of such defense within 15 days after receiving notice of the claim from the Indemnified Party, the
Indemnified Party shall control such defense and, without limiting the Indemnifying Party’s indemnification obligations,
the Indemnifying Party shall reimburse the Indemnified Party for all costs, including reasonable and documented attorney fees,
incurred by the Indemnified Party in defending itself within thirty (30) days after receipt of any invoice therefor from the Indemnified
Party. The Party not controlling such defense may participate therein at its own expense. The Party controlling such defense shall
keep the other Party advised of the status of such action, suit, proceeding or claim and the defense thereof and shall consider
recommendations made by the other Party with respect thereto. The Indemnified Party shall not agree to any settlement of such
action, suit, proceeding or claim without the prior written consent of the Indemnifying Party, which shall not be unreasonably
withheld, delayed or conditioned. The Indemnifying Party shall not agree to any settlement of such action, suit, proceeding or
claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Indemnified
Party from all liability with respect thereto, that imposes any liability or obligation on the Indemnified Party or that acknowledges
fault by the Indemnified Party without the prior written consent of the Indemnified Party. If the Parties cannot agree as to the
application of Section 10.1 or 10.2 to any claim, pending resolution of the dispute pursuant to Article 11, the Parties may conduct
separate defenses of such claims, with each Party retaining the right to claim indemnification from the other Party in accordance
with Section 10.1 or 10.2, as applicable, upon resolution of the underlying claim.

 

10.4
Insurance. Each Party shall procure and maintain adequate levels of insurance that are consistent with industry standards
for similarly situated companies, including comprehensive or commercial general liability insurance (including contractual liability
and product liability). Such insurance shall include commercially reasonable levels of insurance as may be customary in light
of status of activities being conducted. It is understood that such insurance shall not be construed to create a limit of either
Party’s liability with respect to its indemnification obligations under this Article 10 or otherwise. Each Party shall provide
the other Party with written evidence of such insurance upon request. Each Party shall provide the other Party with written notice
at least 30 days prior to the cancellation, non-renewal or material change in such insurance which materially adversely affects
the rights of the other Party hereunder.

 

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Article
11.

DISPUTE RESOLUTION

 

11.1
Disputes. Subject to Section 11.3, any claim, dispute, or controversy as to the breach, enforcement, interpretation or validity
of this Agreement (each, a “Dispute”) that cannot be resolved by the Parties within thirty (30) days
that a Party is notified of such Dispute, will be referred to the Chief Executive Officer of Vactech and the Chief Executive Officer
of Provention for attempted resolution, with each party exercising good faith in such attempt. In the event such executives are
unable to resolve such Dispute within thirty (30) days of such Dispute being referred to them, then, upon the written request
of either Party to the other Party, the Dispute shall be subject to arbitration in accordance with Section 11.2, except as expressly
set forth in Section 11.3.

 

11.2
Arbitration.

 

(a)
Claims. Subject to Section 11.3 below, any Dispute that is not resolved under Section 11.1 within the applicable 30-day period
shall be resolved by final and binding arbitration administered by JAMS (the “Administrator”) in accordance
with its then-effective International Arbitration Rules (the “Rules”), except to the extent any such
Rule conflicts with the express provisions of this Section 11.2. (Capitalized terms used but not otherwise defined in this Agreement
shall have the meanings provided in the Rules.) The Arbitration shall be conducted by one neutral arbitrator selected in accordance
with the Rules, provided that such individual shall not be a current or former employee or director, or a current stockholder,
of either Party or any of their respective Affiliates (or any licensee or sublicensee of the rights granted to such Party under
this Agreement). The arbitration and all associated discovery proceedings and communications shall be conducted in English, and
the arbitration shall be held in New York, NY, USA.

 

(b)
Discovery. Within 30 days after selection of the Arbitrator, the Arbitrator shall conduct the Preliminary Conference. In addressing
any of the subjects within the scope of the Preliminary Conference, the Arbitrator shall take into account both the desirability
of making discovery efficient and cost-effective and the needs of the Parties for an understanding
of any legitimate issue raised in the Arbitration. In that regard, the Parties agree to the application of the E-Discovery procedures
set forth in Rule 16.2(c) of the JAMS Expedited Procedures. In addition, each Party shall have the right to take up to 40 hours
of deposition testimony, including expert deposition testimony.

 

    	 	-43-	 

     

    

 

CONFIDENTIAL

 

(c)
Hearing; Decision. The Hearing shall commence within 60 days after the discovery cutoff. The Arbitrator shall require that
each Party submit concise written statements of position and shall permit the submission of rebuttal statements, subject to reasonable
limitations on the length of such statements to be established by the Arbitrator. The Hearing shall be no longer than 5 business
days in duration. The Arbitrator shall also permit the submission of expert reports. The Arbitrator shall render the Award within
30 days after the Arbitrator declares the Hearing closed, and the Award shall include a written statement describing the essential
findings and conclusions on which the Award is based, including the calculation of any damages awarded. The Arbitrator will, in
rendering his or her decision, apply the substantive law of the State of New York, excluding its conflicts of laws principles
with the exception of Sections 5-1401 and 5-1402 of New York General Obligations Law. The Arbitrator’s authority to award
special, incidental, consequential or punitive damages shall be subject to the limitation set forth in Section 7.7. The Award
rendered by the Arbitrator shall be final, binding and non-appealable, and judgment may be entered upon it in any court of competent
jurisdiction.

 

(d)
Costs. Each Party shall bear its own attorney’s fees, costs, and disbursements arising out of the arbitration, and shall
pay an equal share of the fees and costs of the arbitrator; provided, however, the Arbitrator shall be authorized to determine
whether a Party is the prevailing party, and if so, to award to that prevailing party reimbursement for any or all of its reasonable
attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges, travel
expenses, etc.), and/or the fees and costs of the Administrator and the Arbitrator.

 

11.3
Court Actions. Nothing contained in this Agreement shall deny either Party the right to seek injunctive or other equitable
relief from a court of competent jurisdiction in the context of a bona fide emergency or prospective irreparable harm,
and such an action may be filed and maintained notwithstanding any ongoing discussions between the Parties or any ongoing arbitration
proceeding. In addition, either Party may bring an action in any court of competent jurisdiction to resolve disputes pertaining
to the validity, construction, scope, enforceability, infringement or other violations of Patent Rights or other intellectual
property rights, and no such claim shall be subject to arbitration pursuant to Section 11.2.

 

Article
12.

MISCELLANEOUS

 

12.1
Rights Upon Bankruptcy. All rights and licenses granted under or pursuant to this Agreement are, and shall otherwise be deemed
to be, for purposes of Section 365(n) of Title 11 of the United States Code and other similar laws in any jurisdiction outside
the U.S. (collectively, the “Bankruptcy Laws”), licenses of rights to be “intellectual property”
as defined under the Bankruptcy Laws. If a case is commenced during the Term by or against a Party under Bankruptcy Laws then,
unless and until this Agreement is rejected as provided in such Bankruptcy Laws, such Party (in any capacity, including debtor-in-possession)
and its successors and assigns (including a trustee) shall perform all of the obligations provided in this Agreement to be performed
by such Party. If a case is commenced during the Term by or against a Party under the Bankruptcy Laws, this Agreement is rejected
as provided in the Bankruptcy Laws and the other Party elects to retain its rights hereunder as provided in the Bankruptcy Laws,
then the Party subject to such case under the Bankruptcy Laws (in any capacity, including debtor-in-possession) and its successors
and assigns (including a Title 11 trustee), shall provide to the other Party copies of all Information necessary for such other
Party to prosecute, maintain and enjoy its rights under the terms of this Agreement promptly upon such other Party’s written
request therefor. All rights, powers and remedies of the non-bankrupt Party as provided herein are in addition to and not in substitution
for any and all other rights, powers and remedies now or hereafter existing at law or in equity (including, without limitation,
the Bankruptcy Laws) in the event of the commencement of a case by or against a Party under the Bankruptcy Laws.

 

    	 	-44-	 

     

    

 

CONFIDENTIAL

 

12.2
Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, excluding
its conflicts of laws principles, except as to any issue which depends upon the validity, scope or enforceability of any Patent,
which issue shall be determined in accordance with the laws of the country in which such patent was issued.

 

12.3
Entire Agreement; Amendments. This Agreement (including the Exhibits and Schedules hereto) is both a final expression of the
Parties’ agreement and a complete and exclusive statement with respect to all of its terms. This Agreement supersedes all
prior and contemporaneous agreements and communications, whether oral, written or otherwise, concerning any and all matters contained
herein. The Exhibits and Schedules to this Agreement are incorporated herein by reference and shall be deemed a part of this Agreement.
This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives
of both Parties hereto.

 

12.4
Non-Waiver. The failure of a Party to insist upon strict performance of any provision of this Agreement or to exercise any
right arising out of this Agreement shall neither impair that provision or right nor constitute a waiver of that provision or
right, in whole or in part, in that instance or in any other instance. Any waiver by a Party of a particular provision or right
shall be in writing, shall be as to a particular matter and, if applicable, for a particular period of time and shall be signed
by such Party.

 

12.5
Assignment. Except as expressly provided hereunder, neither this Agreement nor any rights or obligations hereunder may be
assigned or otherwise transferred by either Party without the prior written consent of the other Party (which consent shall not
be unreasonably withheld); provided, however, that either Party may assign this Agreement and its rights and delegate its
obligations hereunder without the other Party’s consent:

 

(a)
in connection with the transfer or sale of all or substantially all of the business of such Party to which this Agreement
relates to a Third Party (“Third Party Acquirer”), whether by merger, sale of stock, sale of assets
or otherwise (each, a “Sale Transaction”); or

 

    	 	-45-	 

     

    

 

CONFIDENTIAL

 

(b)
to an Affiliate, provided that the assigning Party shall remain liable and responsible to the non-assigning Party hereto for
the performance and observance of all such duties and obligations by such Affiliate.

 

The
rights and obligations of the Parties under this Agreement shall be binding upon and inure to the benefit of the successors and
permitted assigns of the Parties, and the name of a Party appearing herein will be deemed to include the name of such Party’s
successors and permitted assigns to the extent necessary to carry out the intent of this section. Any assignment not in accordance
with this Agreement shall be void. In the event of an assignment and assumption of rights and obligations under this Agreement
to a Third Party in connection with a Sale Transaction, the assigning Party shall be relieved of all obligations to the non-assigning
Party assumed by the applicable Third Party.

 

12.6
Force Majeure. Each Party shall be excused from liability for the failure or delay in performance of any obligation under
this Agreement by reason of any event beyond such Party’s reasonable control, including but not limited to Acts of God,
fire, flood, explosion, earthquake, or other natural forces, war, civil unrest, acts of terrorism, accident, destruction or other
casualty, any lack or failure of transportation facilities, any lack or failure of supply of raw materials, any strike or labor
disturbance, or any other event similar to those enumerated above. Such excuse from liability shall be effective only to the extent
and duration of the event(s) causing the failure or delay in performance and provided that the Party has not caused such event(s)
to occur. The affected Party shall notify the other Party of such force majeure circumstances as soon as reasonably practical,
and shall promptly undertake all reasonable efforts necessary to cure such force majeure circumstances.

 

12.7
Severability. If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in
any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected
or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties.
The Parties shall in such an instance use their best efforts to replace the invalid, illegal or unenforceable provision(s) with
valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.

 

12.8
Notices. All notices which are required or permitted hereunder shall be in writing and sufficient if delivered personally,
sent by facsimile or electronic mail (in each case, if promptly confirmed by personal delivery, registered or certified mail or
overnight courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid,
return receipt requested, addressed as follows:

 

	If
    to Vactech, to:	Vactech
    Oy
	 	Minna
    Canthin katu 3 B2
	 	FIN-33230
	 	Tampere
	 	Finland
	 	Attn:
    Heikki Hyöty, Chairman of the Board

 

    	 	-46-	 

     

    

 

CONFIDENTIAL

 

	If
    to Provention, to:	Provention,
    Inc.
	 	110
    Old Driftway Lane
	 	Lebanon,
    NJ 0883
	 	USA
	 	Attn:
    Ashleigh Palmer, President & CEO 
	 	 
	with
    a copy to:	Lowenstein
    Sandler, LLP
	 	65
    Livingston Avenue
	 	Roseland,
    New Jersey 07068
	 	USA
	 	Attn:
    Michael J. Lerner and Herschel Weinstein
	 	Facsimile
    No.: +1 973-597-6395

 

or
to such other address(es) as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance
herewith. Any such notice shall be deemed to have been given: (a) when delivered, if personally delivered or sent by facsimile
on a business day (or if delivered or sent on a non-business day, then on the next business day); (b) on the business day after
dispatch, if sent by nationally-recognized overnight courier; or (c) on the third (3rd) business day following the date of mailing,
if sent by mail.

 

12.9
Interpretation. The headings of clauses contained in this Agreement preceding the text of the sections, subsections and paragraphs
hereof are inserted solely for convenience and ease of reference only and shall not constitute any part of this Agreement, or
have any effect on its interpretation or construction. All references in this Agreement to the singular shall include the plural
where applicable. The term “including” or “includes” as used in this Agreement means including, without
limiting the generality of any description preceding such term, and the word “or” has the inclusive meaning represented
by the phrase “and/or.” Unless otherwise specified, references in this Agreement to any section shall include all
subsections and paragraphs in such section and references in this Agreement to any subsection shall include all paragraphs in
such subsection. All references to days in this Agreement shall mean calendar days, unless otherwise specified. Ambiguities and
uncertainties in this Agreement, if any, shall not be interpreted against either Party, irrespective of which Party may be deemed
to have caused the ambiguity or uncertainty to exist. This Agreement has been prepared in the English language, and the English
language shall control its interpretation. In addition, all notices required or permitted to be given hereunder, and all written,
electronic, oral or other communications between the Parties regarding this Agreement shall be in the English language.

 

    	 	-47-	 

     

    

 

CONFIDENTIAL

 

12.10
Relationship between the Parties. The Parties’ relationship, as established by this Agreement, is solely that of independent
contractors. This Agreement does not create any partnership, joint venture or similar business relationship between the Parties.
Neither Party is a legal representative of the other Party, and neither Party may assume or create any obligation, representation,
warranty or guarantee, express or implied, on behalf of the other Party for any purpose whatsoever.

 

12.11
Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and
in addition to any other remedy referred to in this Agreement or otherwise available under law.

 

12.12
No Third Party Rights. The provisions of this Agreement are for the exclusive benefit of the Parties, and no other person
or entity shall have any right or claim against any Party by reason of these provisions or be entitled to enforce any of these
provisions against any Party.

 

12.13
Further Assurances. Each Party agrees to do and perform all such further acts and things and will 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.

 

12.14
Compliance with Securities Laws. Vactech hereby acknowledges that it is aware, and Vactech shall advise its Affiliates’,
employees, agents, consultants and other representatives who are informed of the matters that are the subject of the Subscription
Agreement, that United States securities laws place certain restrictions on any person who has material, non-public information
concerning an issuer, with respect to purchasing or selling securities of such issuer or from communicating such information to
any other person when it is reasonably foreseeable that such other person is likely to purchase or sell such securities. Vactech
acknowledges its obligation to comply with all applicable securities laws in connection with the ownership of the Founder Shares
and receipt of any Confidential Information of Provention.

 

12.15
Costs. Except as specifically provided in this Agreement, each Party shall be solely responsible for all costs, fees and other
expenses incurred in connection with this Agreement.

 

12.16
Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original document, and all
of which, together with this writing, shall be deemed one instrument. This Agreement may be executed by facsimile or PDF signatures,
which signatures shall have the same force and effect as original signatures.

 

[Remainder
of this page intentionally left blank.]

 

    	 	-48-	 

     

    

 

In
Witness Whereof, the parties hereto have duly
executed this License Agreement as of the Effective Date.

 

	Vactech
    oy	 
	 	 	 
	By:	/s/
    Raimo Harju	 
	Name:	Raimo
    Harju	 
	Title:	Chief
    Executive Officer	 
	 	 	 
	Vactech
    oy	 
	 	 	 
	By:	/s/
    Heikki Hyöty	 
	Name:	Heikki
    Hyöty	 
	Title:	Chairman
    of the Board	 

 

[Signature
Page to Vactech License Agreement]

 

    	 	 	 

     

    

 

	Provention
    Bio, Inc.	 
	 	 	 
	By:	/s/
    Ashleigh Palmer	 
	Name:	Ashleigh
    Palmer	 
	Title:	President	 

 

[Signature
Page to Vactech License Agreement]

 

    	 	 	 

     

    

 

Exhibit
A

 

Vactech
Patent Rights as of the Effective Date

 

[****]

 

    	 	A-1	 

     

    

 

Exhibit
B

 

Vactech
Asthma and Allergy Patents

 

For
the sake of clarity the Vactech Asthma and Allergy related patents and/or patent applications listed in this Exhibit B are NOT
included with the License.

 

[****]

 

    	 	Exhibit B-1CONFIDENTIAL
TREATMENT REQUESTED: Certain portions of this document have been omitted pursuant to a request for confidential treatment and,
where applicable, have been marked with an asterisk (“[*****]”) to denote where omissions have been made. The confidential
material has been filed separately with the Securities and Exchange Commission.

 

LICENSE,
DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

 

between

 

JANSSEN
PHARMACEUTICA NV

 

and

 

PROVENTION
BIO, INC.

 

    	 	1	 

     

    

 

LICENSE,
DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

 

This
license, development and commercialization agreement, effective as of the last date of execution by the parties hereto (“Effective
Date”), is between Janssen Pharmaceutica NV, a company organized under the laws of Belgium, with its principal offices
at Turnhoutseweg 30, 2340 Beerse, Belgium (“Janssen”) and Provention Bio, Inc., a company organized under the
laws of Delaware, with its principal offices at 110 Old Driftway Lane, Lebanon, New Jersey 08833 (“Provention”).

 

BACKGROUND

 

Janssen
conducts research and develops therapeutic compounds for a variety of focus areas, including a colony stimulating factor 1 receptor
(“CSF1R”) inhibitor compound (designated “JNJ-40346527”).

 

Provention
develops and commercializes therapeutic compounds for the treatment of various human diseases.

 

The
parties want to have Provention develop and commercialize JNJ-40346527 for therapeutic use in human inflammatory bowel disease,
including Crohn’s Disease and ulcerative colitis.

 

The
parties therefore agree as follows:

 

ARTICLE
1: DEFINITIONS

 

	1.1	 “1st
    Indication” or “First Indication” means any indication listed under the header “INDICATIONS
    AND USAGE” of a Product’s approved label upon Regulatory Approval for the Product by a Regulatory Authority, including
    any patient group, population or subpopulation, including but not limited to an indication for treatment in the Field.
	 	 
	1.2	“2nd
    Indication” or “Second Indication” means any disease or condition listed under the header “INDICATIONS
    AND USAGE” of a Product’s approved label upon Regulatory Approval for the Product by a Regulatory Authority other
    than the First Indication. 
	 	 
	1.3	 “Affiliate”
    means, with respect to any person, any other person that directly or indirectly controls, is controlled by or is under direct
    or indirect common control with, such person. For purposes of this section 1.3, the term “control” means the possession,
    direct or indirect, of the power to direct or cause the direction of the management and policies of a person, whether through
    the ownership of voting securities, by contract or otherwise. Control of any person by another person shall be presumed if
    fifty percent (50%) or more of the securities or other ownership interests representing the equity, the voting stock or general
    partnership interest of the first person are owned, controlled or held, directly or indirectly, by the other person, or by
    an Affiliate of the other person. A person, for the purpose of this definition, means any individual, corporation, partnership,
    association, joint-stock company, trust, unincorporated organization or government or political subdivision thereof.

 

    	 	2	 

     

    

 

	1.4	 “BLA”
    means a biologics license application, or similar application, submitted to a Regulatory Authority.
	 	 
	1.5	“Calendar
    Quarter” means a calendar quarter during any Calendar Year based on the J&J Universal Calendar for that year
    consistent with the J&J Universal Calendar used for Janssen’s internal business purposes; provided, however that
    the last Calendar Quarter under this agreement will extend from the first day of such Calendar Quarter until the effective
    date of the termination or expiration of this agreement.
	 	 
	1.6	“Calendar
    Year” means a calendar year during the term of this agreement based on the J&J Universal Calendar for that year
    consistent with the J&J Universal Calendar used for Janssen’s internal business purposes; provided, however that
    the last Calendar Year under this agreement shall extend from the first day of such Calendar Year until the effective date
    of the termination or expiration of this agreement.
	 	 
	1.7	“Change
    of Control” means a transaction or series of related transactions that result in (a) the holders of outstanding
    voting securities of a Party immediately prior to such transaction ceasing to represent at least fifty percent (50%) of the
    combined outstanding voting power of the surviving entity immediately after such transaction; (b) any Third Party (other than
    a trustee or other fiduciary holding securities under an employee benefit plan) becoming the beneficial owner of fifty percent
    (50%) or more of the combined voting power of the outstanding securities of a Party; or (c) a sale or other disposition to
    a Third Party of all or substantially all of a Party’s assets or business.
	 	 
	1.8	 “Clinical
    Trial” means any research study of a therapeutic product with human subjects designed to provide specific data to
    determine either or both the safety and efficacy of such product.
	 	 
	1.9	 “Commercialize”
    or “Commercialization” means any action directed to marketing, promoting, distributing, importing or selling
    a pharmaceutical product, obtaining pricing or reimbursement approvals for that product and Clinical Trials of a Product conducted
    after Regulatory Approval for that Product, including label expansion, pricing/reimbursement, epidemiological, modeling and
    pharmacoeconomic, voluntary post-marketing surveillance and health economics studies.
	 	 
	1.10	“Confidential
    Information” means any information or data, including all scientific, pre-clinical, clinical, regulatory, manufacturing,
    marketing, financial and commercial information or data, whether communicated in writing, electronically or orally or by any
    other method, that is identified as confidential.
	 	 
	1.11	“Control”
    or “Controlled” means, with respect to intellectual property, the ownership or other legal authority or
    right of a Party to grant a license or sublicense of intellectual property to the other Party, in all cases as of the Effective
    Date or at any time during the Term.

 

    	 	3	 

     

    

 

	1.12	“Combination
    Product” means (i) a Product that contains at least one Compound and at least one additional therapeutically active
    ingredient that is not a Compound, or (ii) a product consisting of one or more separate drugs, devices, tests, kits or biological
    products and sold together with a Product containing or consisting of a Compound (alone or with other active ingredients)
    in a single package or as a unit.
	 	 
	1.13	“Compound”
    means JNJ-40346527, and derivatives, related compounds, combinations, precursors, conjugates and potential modifications thereof.
	 	 
	1.14	“Development”
    or “Develop” means any non-clinical and clinical drug development activities from the initiation of GLP
    studies that are undertaken or planned in order to obtain or maintain Regulatory Approval.
	 	 
	1.15	“Diligent
    Efforts” means those efforts and resources reasonably and normally used in the development and commercialization
    by bio-pharmaceutical companies for a product that is of similar market potential, at a similar stage in its development or
    product life, and that has a similar potential market opportunity as the applicable Product, taking into account issues of
    safety, efficacy, target product profile, proprietary position and profitability of the Product, and other relevant regulatory,
    scientific, technical, business, marketing, and commercial factors.
	 	 
	1.16	“EMA”
    means the European Medicines Agency or any successor agency that is responsible for reviewing applications seeking approval
    for the sale of pharmaceuticals in the EU.
	 	 
	1.17	“European
    Commission” means the European Commission or any successor agency that is responsible for granting marketing approvals
    authorizing the sale of pharmaceuticals in the EU.
	 	 
	1.18	“European
    Union” or “EU” means the countries of the European Union, as the European Union is constituted
    as of the Effective Date and as it may be modified from time to time.
	 	 
	1.19	 “FDA”
    means the U.S. Food and Drug Administration, or any successor government agency that is responsible for approving the sale
    of pharmaceuticals in the United States.
	 	 
	1.20	“Field”
    means human use for inflammatory bowel disease, including Crohn’s Disease and ulcerative colitis.
	 	 
	1.21	“First
    Commercial Sale” means, with respect to any Product, the first arm’s length sale of such Product to a Third
    Party in a country of the Territory by a Party, its Affiliate(s) or sublicensee(s) for use or consumption in such country
    following Regulatory Approval. Sales prior to receipt of marketing and pricing approvals, such as so-called “treatment
    IND sales,” “named patient sales” and “compassionate use sales” shall not be considered a “First
    Commercial Sale.”
	 	 
	1.22	“HSR
    Act” means (a) the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations
    promulgated thereunder, and (b) any applicable foreign equivalent thereof.
	 	 
	1.23	“HSR
    Clearance Date” means the expiration or termination of all applicable waiting periods and requests for information
    (and any extensions thereof) under the HSR Act.

 

    	 	4	 

     

    

 

	1.24	“HSR
    Filing” means (a) filings by Provention and Janssen with the United States Federal Trade Commission and the Antitrust
    Division of the United States Department of Justice of a Notification and Report Form for Certain Mergers and Acquisitions
    (as that term is defined in the HSR Act) with respect to the matters set forth in this agreement, together with all required
    documentary attachments thereto, or (b) equivalent filings with relevant foreign authorities.
	 	 
	1.25	“Invention”
    means any process, method, use, protocol, formula, data, composition of matter, article of manufacture, discovery or finding,
    in each case whether or not patentable. 
	 	 
	1.26	“Joint
    Know-How” means all information, materials, Inventions and trade secrets, not generally known to the public, that
    are not Joint Patent Rights, discovered, developed, or conceived of jointly by employees of Provention and Janssen or their
    Affiliates, or by others acting on behalf of Provention and Janssen, in the course of activities undertaken under this agreement.
	 	 
	1.27	“Joint
    Patent Rights” means all Patent Rights Controlled jointly by both (i) Janssen and (ii) Provention or any of its
    Affiliates that would be infringed by the making, using, selling, offering for sale, or import of a Product, but for the licenses
    granted in this agreement. Joint Patent Rights shall be set forth on Schedule 4, which shall be updated from time to time
    by the Parties.
	 	 
	1.28	“Janssen
    Know-How” means Janssen proprietary data, including Know-How that are not Janssen Patent Rights, and that are Controlled
    by Janssen or any of its Affiliates. Janssen Know-How includes Benchmark Data (as defined in Schedule 1). 
	 	 
	1.29	“Janssen
    Patent Rights” means all Patent Rights Controlled by Janssen or any of its Affiliates that would be infringed by
    the making, using, selling, offering for sale, or import of a Product, but for the licenses granted in this agreement. Janssen
    Patent Rights shall be set forth on Schedule 3, which shall be updated from time to time by the Parties to account for the
    progress of patent prosecution and additional Patent Rights on the JNJ-40346527 compound that Janssen Controls during the
    Term.
	 	 
	1.30	“Know-How”
    means all information, materials, Inventions and trade secrets, not generally known to the public, that are Controlled by
    a Party or any of its Affiliates (a) (i) as of the Effective Date, or (ii) are discovered, created or developed, in the course
    of the Party’s performance of activities under this agreement, and (b) are related to the discovery, Development, use,
    Manufacture or Commercialization of any Product. 
	 	 
	1.31	“MAA”
    means a marketing authorization application, or similar application: (a) submitted to the EMA in the European Union; or (b)
    submitted to a Regulatory Authority in the United Kingdom in the event the United Kingdom ceases to be subject to the jurisdiction
    of the EMA, for instance as a consequence of its exit from the European Union.
	 	 
	1.32	“MAA
    Approval” means (i) receipt of regulatory approval for a Product for the relevant indication in at least one of
    France, Germany, Italy, Spain, and United Kingdom, and (ii) if required for marketing, receipt of pricing/reimbursement approval
    for such Product for such indication in such country.

 

    	 	5	 

     

    

 

	1.33	“Major
    Market” means any of the United States, the EU and Japan.
	 	 
	1.34	“Manufacturing”
    or “Manufacture” means the activities relating to producing a Product, including purchasing raw materials
    and intermediates, producing active pharmaceutical ingredient, formulating and tableting, and all related quality control
    and quality assurance activities and all storage, shipping, handling, packaging and manufacturing technical transfer activities.
    
	 	 
	1.35	“MHLW”
    means Japan’s Ministry of Health, Labor and Welfare, or any successor government agency that is responsible for approving
    the sale of pharmaceuticals in Japan.
	 	 
	1.36	 “NDA”
    means a new drug application, or similar application, submitted to the FDA in the United States.
	 	 
	1.37	“Net
    Sales” means the gross amount invoiced by the licensee or its Related Parties in arms-length sales of a Product
    in the Field to a Third Party, less the following customary and commercially reasonable deductions, determined in accordance
    with U.S. generally accepted accounting principles and internal policies and actually taken, paid, accrued, allocated, or
    allowed based on good faith estimates:

 

	 	(a)
    	trade,
    cash and/or quantity discounts, allowances, and credits, excluding commissions for commercialization;
	 	 	 
	 	(b)
    	excise
    taxes, use taxes, tariffs, sales taxes and customs duties, and/or other government charges imposed on the sale of Product
    (including VAT, but only to the extent that such VAT taxes are not reimbursable or refundable), specifically excluding, for
    clarity, any income taxes assessed against the income arising from such sale;
	 	 	 
	 	(c)
    	compulsory
    or negotiated payments and cash rebates or other expenditures to governmental authorities (or designated beneficiaries thereof)
    in the context of any national or local health insurance programs or similar programs; including, but not limited to, pay-for-performance
    agreements, risk sharing agreements as well as government levied fees as a result of the Affordable Care Act;
	 	 	 
	 	(d)
    	rebates,
    chargebacks, administrative fees, and discounts (or equivalent thereof) to managed health care organizations, group purchasing
    organizations, insurers, pharmacy benefit managers (or equivalent thereof), specialty pharmacy providers, governmental authorities,
    or their agencies or purchasers, reimbursers, or trade customers, as well as amounts owed to patients through co-pay assistance
    cards or similar forms of rebate to the extent the latter are directly related to the prescribing of the Product;
	 	 	 
	 	(e)
    	outbound
    freight, shipment and insurance costs to the extent included in the price and separately itemized on the invoice price;

 

    	 	6	 

     

    

 

	 	(f)
    	retroactive
    price reductions, credits or allowances actually granted upon claims, rejections or returns of Product, including for recalls
    or damaged or expired goods, billing errors and reserves for returns;
	 	 	 
	 	(g)
    	any
    invoiced amounts which are not collected by the selling party or its Affiliates, including bad debts; and
	 	 	 
	 	(h)
    	any
    deductions in the context of payments that are due or collected significantly after invoice issuance.

 

All
aforementioned deductions shall only be allowable to the extent they are commercially reasonable by the licensee and shall be
determined, on a country-by-country basis, as incurred in the ordinary course of business in type and amount verifiable based
on the licensee and its Related Parties’ reporting system. All such discounts, allowances, credits, rebates, and other deductions
shall be fairly and equitably allocated to Product and other products, if applicable, of the licensee and its Related Parties
such that Product does not bear a disproportionate portion of such deductions.

 

The
following provisions shall also apply to Net Sales:

 

	 	(i)
    	Sales
    of Product by and between a licensee and its Affiliates and sublicensees are not sales to Third Parties and shall be excluded
    from Net Sales calculations for all purposes.
	 	 	 
	 	(ii)
    	Sales
    of Product for the use in conducting clinical trials or other scientific testing of Product in a country shall be excluded
    from Net Sales calculations for all purposes.
	 	 	 
	 	(iii)
    	Compassionate
    and named patient sales or sales on an Affordable Basis shall be excluded from Net Sales calculations for all purposes. “Affordable
    Basis” shall mean making a product available to patients at lowest cost possible. For clarification, Affordable Basis
    is satisfied if a Party sells such product for no more than the Cost of Goods Sold plus an additional percentage that is required
    to cover the costs and expenses of such Party’s commercialization and logistics activities with respect to such product
    in the applicable country. In determining Affordable Basis, the Parties recognize that, to the extent that a Party engages
    a Third Party in the commercialization of a product on an Affordable Basis, such Third Party shall be entitled to a reasonable
    profit margin, as customary in the generic drug industry for such country; provided that the applicable Party uses commercially
    reasonable efforts to minimize such Third Party profits.
	 	 	 
	 	(iv)
    	Any
    disposition of the Product as free samples, donations, patient assistance, test marketing programs or other similar programs
    or studies, shall be excluded from Net Sales calculations for all purposes.

 

In
the case of any sale that is not invoiced, Net Sales are calculated at the time of transfer of title of the Product based on the
gross selling price in that transaction. In the case of any sale or disposal for value other than in an arms-length transaction
exclusively for money, such as barter or counter trade, Net Sales are calculated as above on the value of the consideration received
or the fair market value (if higher) of the Product in the country of sale or disposal.

 

    	 	7	 

     

    

 

In
the event that any Product is sold in the form of Combination Products containing one or more other products, where all products
in such Combination Product are sold separately, Net Sales for such Combination Products will be calculated by multiplying actual
Net Sales of such Combination Products by the fraction A/(A+B) where A is the invoice price of the Product if sold separately,
and B is the total invoice price of any other product or products in the combination if sold separately. To the extent that one
or more of the products, including the Product, in any Combination Product are not sold separately, the following provisions shall
apply:

 

	 	(1)	If
    the Product contained in the Combination Product is sold separately, but none of the other products included in such Combination
    Product are sold separately, Net Sales shall be calculated by multiplying actual Net Sales of such Combination Product as
    determined under the first paragraph of this Section 1.37, by the fraction A/C, where A is the net invoice price of such Product
    component as sold separately in such country, and C is the net invoice price of the Combination Product in such country. 
	 	 	 
	 	(2)	If
    the Product component of the Combination Product is not sold separately, but the other product(s) included in the Combination
    Product are sold separately in such country, Net Sales shall be calculated by multiplying actual Net Sales of such Combination
    Product in such country as determined under the first paragraph of this Section 1.37, by the fraction (C-D)/C, where C is
    the net invoice price of the Combination Product, and D is the sum of the net invoice prices charged for the other product(s)
    in the Combination Product.
	 	 	 
	 	(3)	If
    none of the product(s) included in the Combination Product, including the Product, are sold separately, or if the Product
    is intended to be sold as a fixed dose combination, Net Sales for the purpose of determining royalties due hereunder for the
    Combination Product shall be determined by mutual agreement of the Parties in good faith taking into account the perceived
    relative value contributions of the Product portion of the Combination Product and the other product(s) in the Combination
    Product. In case of disagreement, an independent expert agreed upon by both Parties or, failing such agreement, designated
    by the International Chamber of Commerce, shall determine such relative value contributions and such determination shall be
    final and binding upon the Parties.

 

Net
Sales includes sales of a Product to the U.S. Strategic National Stockpile, or to equivalent governmental agencies in U.S. states
or foreign jurisdictions that are intended to act as central repositories of medicines and other therapeutic supplies to be used
to safeguard public health and supplement local supplies in the event of potentially catastrophic disease outbreaks, even if such
sales occur prior to receipt of marketing and pricing approvals. Notwithstanding anything above to the contrary, such sales to
governmental stockpiles will be calculated, for each such sale of Product by the licensee or its Related Parties, at the earlier
of the time of delivery to or the invoicing of the applicable governmental agency.

 

    	 	8	 

     

    

 

	1.38	“Party”
    means Provention or Janssen, and “Parties” means Provention and Janssen.
	 	 
	1.39	“Patent
    Proceeding” means any opposition, re-issue, and re-examination, and any contested case, including inter-partes review,
    post-grant review, interference, derivation or similar proceedings.
	 	 
	1.40	“Patent
    Rights” means all national, regional and international patents and patent applications, including divisions, continuations,
    continuations-in-part, additions, re-issues, renewals, extensions, substitutions, re-examinations or restorations, registrations
    and revalidations, and supplementary protection certificates and equivalents to any of the foregoing.
	 	 
	1.41	“Phase
    2 Clinical Trial” means a clinical trial generally consistent with 21 CFR §312.21(b) that is required for receipt
    of Regulatory Approval of a Product and which is conducted to evaluate the effectiveness and the appropriate dose range of
    a Product for a particular indication or indications in patients with the disease or condition under study and to determine
    the common short-term side effects and risks. 
	 	 
	1.42	“Phase
    3 Clinical Trial” means a clinical trial generally consistent with 21 CFR §312.21(c) that is required for receipt
    of Regulatory Approval of a Product and which is conducted after preliminary evidence suggesting effectiveness of the drug
    has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of
    the drug and provide an adequate basis for physician labeling.
	 	 
	1.43	“Product”
    means any and all pharmaceutical compositions or preparations (in any and all dosage forms), in final form, containing one
    or more Compounds as active ingredients either alone or in combination with one or more other active ingredients (Combination
    Product).
	 	 
	1.44	“Regulatory
    Approval” means approval and authorization, by governmental entities, required for marketing and commercial sale
    of a Product in a country or region, such as an NDA or BLA in the United States, an MAA or BLA in the European Union and a
    JNDA or BLA in Japan.
	 	 
	1.45	“Regulatory
    Authority” means any applicable government regulatory authority involved in granting Regulatory Approval in the
    Territory, including the FDA, EMA/European Commission and MHLW.
	 	 
	1.46	“Related
    Party” means each of a licensee’s Affiliates and permitted sublicensees.
	 	 
	1.47	“Securities
    Act” shall mean the Securities Act of 1933, as amended.
	 	 
	1.48	“Standard
    Cost” means Janssen’s reasonable and necessary internal and third party costs incurred in the manufacture
    or acquisition of product, determined in accordance with Janssen’s standard cost accounting policies that are in accordance
    with U.S. generally accepted accounting principles and consistently applied across Janssen’s manufacturing network to
    other products that Janssen manufactures.

 

    	 	9	 

     

    

 

	1.49	“Tax”
    or “Taxes” means any present or future taxes, levies, imposts, duties, charges, assessments or fees of
    any nature (including any interest thereon).
	 	 
	1.50	“Territory”
    means all of the countries in the world, and their territories and possessions.
	 	 
	1.51	“Third
    Party” means an entity other than Provention and Janssen and their Affiliates and Related Parties. 
	 	 
	1.52	 “USD”
    or “U.S. Dollars” means United States dollars.
	 	 
	1.53	“Valid
    Claim” means: (a) any claim of an issued unexpired patent that (i) has not been finally cancelled, withdrawn,
    abandoned or rejected by any administrative agency or other body of competent jurisdiction; (ii) has not been permanently
    revoked, or held invalid by a decision of a court or other body of competent jurisdiction that is unappealable or unappealed
    within the time allowed for appeal; (iii) has not been rendered unenforceable through terminal disclaimer or otherwise; and
    (iv) is not lost through an interference proceeding that is unappealable or unappealed within the time allowed for appeal,
    or (b) a claim of a pending patent application where such claim has been pending for a period of seven years or less. If a
    claim of a pending patent application that ceased to be a Valid Claim under this sub-section (b) of this section later issues
    or grants as a patent within the scope of sub-section (a), then such claim is considered to be a Valid Claim from the date
    of such issue or grant.
	 	 
	1.54	Additional
    Definitions. Each of the following definitions is set forth in the Section of this agreement indicated below:

 

	Definition	 	Section
	Excluded
    Claim	 	12.8
	Executive
    Officer	 	12.8
	Indemnitee	 	12.1.3
	Indemnitor	 	12.1.3
	Milestone
    Event	 	8.2.1
	Milestone
    Payment	 	8.2.1
	New
    IP and associated terms	 	10.1.1
	Option
    and associated terms	 	4.1
	Outside
    Patent Counsel	 	10.1.1
	Qualified
    Financing	 	2.1(a)
	Study	 	3.1

 

    	 	10	 

     

    

 

	Definition

        
	 	Section

        

	Term	 	11.1
	Third
    Party Claim	 	12.1.1
	Third
    Party Licenses	 	8.2.1(b)
	Transition
    Plan	 	3.1
	Valid
    Safety Issue	 	11.2.2

 

ARTICLE
2: FINANCING OF PROVENTION/AUTOMATIC TERMINATION

 

2.1
Financing. The performance of this agreement, including the granting of the licenses under Article 6, is conditional on the
occurrence of the following:

 

	 	(a)
    	Execution
    of an agreement(s) for the Qualified Financing of Provention, where “Qualified
    Financing” shall mean a bona fide equity financing in which Provention closes on at least $25,000,000 of equity financing
    that complies with the Securities Act or any exemption from registration thereunder. 

 

2.2
Automatic Termination. This agreement, including the licenses granted to Provention under Article 6, shall terminate automatically
if the financing requirements of section 2.1 are not achieved prior to, or within ninety (90) days following, the Effective Date;
provided that Provention may request Janssen’s approval for a ninety (90) day extension, which approval shall not be unreasonably
withheld.

 

ARTICLE
3: DEVELOPMENT OBLIGATION/COMPETITION

 

	3.1	Development
    Obligation. In partial consideration for the license granted to Provention under Article 6 of this agreement, Provention
    (at its own expense) will complete a single Phase 2a proof-of-mechanism (PoM) and proof-of-concept (PoC) clinical trial (the
    “Study”) of a Product in Crohn’s Disease. The Study design will be developed and agreed upon by Janssen
    and Provention, according to the plan shown in Schedule 1 (the “Transition Plan”) as well as the Preliminary Clinical
    Plans attached at Schedule 2. Schedule 1 and Schedule 2 may be modified by mutual written agreement of the Parties. The clinical
    trial preparations will commence upon receipt of all information and materials supplied under the Transition Plan and the
    Study shall be designed and implemented to follow the agreed-upon Study design and to conclude within thirty-six (36) months
    after commencement. Failure to initiate or conclude the Study shall be grounds for Janssen to terminate this agreement. The
    Parties may agree to delay completion of the Study, for instance in the event of circumstances that are outside of Provention’s
    reasonable commercial control (such as a regulatory hold). Notwithstanding the foregoing, shall be entitled to an additional
    three (3) month period in which to complete the Study in the event the conclusion of the Study is delayed by circumstances
    beyond its control. 

 

    	 	11	 

     

    

 

	3.2	Reporting.
    Prior to the completion of the Study, Janssen and Provention will hold quarterly meetings (by telephone or videoconference
    unless otherwise agreed) at which qualified representatives of Provention responsible for Product development will report
    to Janssen, and respond to Janssen’s questions regarding the progress and results of Provention’s Product development
    efforts. In the event that the Buy-Back Option of Article 4 is not exercised by Janssen, Provention shall provide written
    updates semiannually regarding the development status of any Product or any Product-related regulatory submissions and approvals,
    or any Product-related Commercialization efforts in the Territory. Following the First Commercial Sale, Provention will provide
    quarterly net sales and royalty reports as further detailed in Article 8. 
	 	 
	3.3	Pharmacovigilance
    Safety Reporting. The Parties shall meet to negotiate in good faith and agree on processes and procedures for sharing
    adverse event and other safety information related to the Product prior to any marketing or clinical activity governing pharmacovigilance
    obligations for the Product in the Territory. Such written plan (“Pharmacovigilance Agreement”) shall ensure that
    adverse event and other safety information are exchanged according to a schedule that will permit each Party to comply with
    legal and regulatory requirements in its respective territories. 
	 	 
	 	Provention
    shall establish the global safety database of adverse events and relevant safety information, including but not limited to
    pregnancy reports for the Product that will be used to support regulatory reporting, overall drug safety surveillance and
    responses to safety queries from Regulatory Authorities for their sponsored clinical trials.

 

3.4
Manufacture and Supply. Until such time as Janssen has irrevocably waived its option to assume distribution under Section
5.2.4, Janssen shall Manufacture Compound for Provention. The Parties shall negotiate a supply agreement under which Janssen would
supply the same Compound to Provention for development and commercialization within the Field. The terms of such supply agreement
shall be negotiated in good faith, it being understood and agreed that the Compound would be sold to Provention at a price equal
to the then Standard Cost of the Compound plus [*****] ([*****]%). Upon any termination or expiration of the supply agreement
contemplated by the previous sentence, Janssen shall assist Provention in transferring the Compound’s Manufacturing process
to Provention or to a third party manufacturer that is acceptable to both Parties at terms and cost to be negotiated, with Provention
being responsible for all costs of the transfer including the Janssen costs.

 

ARTICLE
4: BUY-BACK OPTION

 

4.1
Subject to section 11.7, Provention hereby grants to Janssen an exclusive option to buy back the rights Provention received
under the license of Article 6 to permit Janssen to exclusively Develop and Commercialize Compound and Products in the Field (the
“Option”). Provention shall provide a written notice to Janssen at the conclusion of the Study (the “Notice
of Option”), which shall describe the data possessed by Provention demonstrating how the Compound performed in the Study.
Janssen shall have ninety (90) days from the date of such notification (the “Option Period”) to exercise the Option.
If Janssen declines or otherwise fails to exercise its Option prior to the expiration of the Option Period, then Janssen’s
rights hereunder to Develop and Commercialize such Products in the Field shall terminate and Provention may thereafter Develop
and Commercialize the Product, for use in the Field, as further described in this agreement.

 

    	 	12	 

     

    

 

4.2
In the event Janssen elects to exercise its Option as provided in section 4.1, above, then upon Janssen’s notice of
such election:

 

	 	(a)	The
    license to Provention by Janssen pursuant to Article 6 shall terminate and revert to Janssen; and
	 	 	 
	 	(b)	Provention
    agrees to grant, and does hereby grant, to Janssen an exclusive, sublicensable, license under any Provention New IP (as defined
    in section 10.1.1) and Patents Rights thereon, and under Provention’s interest in Joint IP and any Patent Rights on
    Joint IP, to discover, develop, make, have made, import, export, use, offer for sale and sell, and otherwise commercialize
    any Compound or Product in the Field in the Territory; and 
	 	 	 
	 	(c)	Provention
    shall transfer to Janssen all information in its possession related to such Compound or Product including: (i) testing information,
    (ii) synthesis information, (iii) Provention New IP related to the foregoing; and
	 	 	 
	 	(d)	Provention
    shall transfer to Janssen all quantities of Compound remaining in its possession; and
	 	 	 
	 	(e)	Provention
    shall transfer to Janssen all information in its possession that could reasonably be expected to support any subsequent Regulatory
    Approval activity that is related to such Compound or Product in the Field; and
	 	 	 
	 	(f)	Janssen
    shall pay to Provention the fee and royalties described in section 4.3; and
	 	 	 
	 	(g)	Janssen,
    either by itself or through its Affiliates, shall be responsible for all further Development and Commercialization of such
    Compounds and Products in the Field.

 

4.3
Payments. If the Option of section 4.1 is exercised by Janssen, the following payment and associated terms shall apply.

 

4.3.1
One-Time Fee. Janssen shall pay to Provention a one-time only fee of [*****] U.S. dollars (US$[*****]). This one-time fee
shall be due within ninety (90) days of the exercise of the Option.

 

4.3.2
Royalties. Janssen will pay Provention royalties, at a royalty rate of [*****] percent ([*****]%) per Calendar Year, on Net
Sales of Product in the Field. The period in which royalties are payable for Product sales in the Field in a given country ends
upon the later to occur of (i) ten (10) years from the initial First Commercial Sale of a Product in the country or (ii) expiration
of the last-to-expire Valid Claim within the Janssen Patent Rights, Joint Patent Rights or patent rights of Provention on Provention
New IP, that is issued in such country of sale and, but for the rights granted herein, would be infringed by such sale of such
Product.

 

    	 	13	 

     

    

 

4.3.3
Other Royalty Provisions. All royalties under section 4.3.2 are subject to the following conditions:

 

(a)
only one royalty will be due with respect to the same unit of a Product. No multiple royalty will be payable based on being
covered by more than one Valid Claim;

 

(b)
no royalties will be due upon the sale or other transfer among Janssen or its Related Parties; and

 

(c)
no royalties will be due on the disposition of a Product by Janssen or its Related Parties in reasonable quantities provided
as samples (promotional or otherwise) or as donations (for example, to non-profit institutions or government agencies for a non-commercial
purpose).

 

4.3.4
Expiration of Royalty Obligations. Janssen retains the right, which includes retaining a nonexclusive license in the Territory
under Provention New IP (including know-how) and Patent Rights thereon, to make, use, sell, import and have such acts performed
for Janssen’s benefit following expiration of all royalty obligations in respect of any Product.

 

4.3.5
Other Applicable Terms. The terms of the following sections from Article 8 shall apply to Janssen, mutatis mutandis:
section 8.4 (Reports and Payments); section 8.5 (Audits); section 8.6 (Income Tax Withholding); section 8.7 (Currency Restrictions);
section 8.9 (Interest); and section 8.10 (Payments).

 

4.4
Termination for Non-Commercialization. In the event that Provention does not achieve a First Commercial Sale of Product in
the Field within ten years of the Effective Date of this agreement then, unless otherwise agreed by both Parties, the license
grant to Provention under Article 6 shall automatically terminate (and revert to Janssen) and no fees or royalties will be due
from Janssen.

 

ARTICLE
5: DEVELOPMENT; MANUFACTURING; COMMERCIALIZATION

 

5.1
Development Responsibility and Costs. Provention has the exclusive right and sole responsibility for, and shall bear all of
the cost of implementing Development activities, including conducting the Study.

 

5.2
If Janssen does not exercise its Option under Article 4, then the following Regulatory Approval and Commercialization terms
shall apply:

 

5.2.1
Regulatory Approvals. Provention shall be solely responsible, at its own expense, for preparing and submitting registration
dossiers for Regulatory Approval of Products (including Combination Products) for use in the Field in the Territory. All such
Regulatory Approvals will be held by and in the name of Provention, and Provention will own all submissions in connection with
them. Provention shall have sole discretion for the regulatory strategy and decision-making for all Products in the Field.

 

    	 	14	 

     

    

 

5.2.2
Commercialization. Subject to sections 5.2.3 and 5.2.4, Provention shall have the exclusive right to Commercialize Products
in the Field in the Territory and will bear all costs associated with marketing, sale and distribution of Products, including
Manufacture and supply of Products. All decisions regarding Commercialization of Products will be made by Provention in its sole
discretion until such time as Janssen invokes the option stated in section 5.2.4, below.

 

5.2.3
Labeling and Marketing. Janssen retains the right to make all development and Commercialization decisions for the Compound
or Products outside of the Field.

 

5.2.4
Option to Assume Distribution. In addition, Janssen shall have the option to assume exclusive responsibility for global distribution
of all Products in all fields, including within the Field. If Janssen exercises this option, the Parties shall negotiate in good
faith and shall execute a distribution agreement, which agreement shall effect, to the extent permitted by applicable law, at
least the following provisions:

 

The
objective of the distribution agreement shall be providing to each of Janssen and Provention the same economic participation and
risk-sharing in the Compound and Products, as nearly as may be and taking account of the transaction as a whole, to the economic
participation and risk-sharing to which each such Party would have been subject in the event the option had not been exercised;

 

A
one-time payment by Janssen to Provention of $[*****] for the right to distribute the Product in the Field;

 

Janssen
shall be solely responsible for and have sole authority with respect to all aspects of the distribution of Products in all fields
globally, including in the Field in the Territory;

 

Janssen
shall have final decision-making responsibility on labeling and marketing of all Product in the Field, and Provention shall cooperate
with Janssen with regard to labeling and marketing;

 

Provention
shall refer any orders it receives for a Product to Janssen for distribution;

 

Janssen
shall be solely responsible for and shall have final decision-making authority with respect to all decisions regarding the prices
charged and discounts, rebates and other sale and reimbursement terms and conditions for Products in all fields, including in
the Field;

 

Janssen
and Provention shall cooperate to manage any agreements in place between Provention and any third party with respect to Commercialization
of Products in the Field at the time the option is exercised that are directly impacted by Janssen’s assumption of distribution
activities; and

 

    	 	15	 

     

    

 

Janssen
may subcontract distribution responsibilities to any of its Affiliates or any Third Party, provided that Janssen shall oversee
the performance of any subcontracted activities in a manner that would be reasonably expected to result in their successful and
timely completion and shall remain responsible for the performance of such subcontracted activities in accordance with the terms
of the distribution agreement.

 

5.2.5
Trademarks. Provention will develop, select, maintain, and own trademark(s) for the Product(s) in the Field in the Territory.
Janssen retains the right to develop, select, maintain, and own trademark(s) for the Product(s) in all fields outside of the Field.

 

ARTICLE
6: LICENSE

 

6.1
License Grant. Subject to section 11.7 hereof, Janssen hereby grants to Provention: (a) an exclusive (even as to Janssen),
royalty-bearing license under the Janssen Patent Rights and Janssen Know-How related to the Compounds that is specific for any
Product in the Field in the Territory, and (b) a non-exclusive, royalty-bearing license to the Janssen Know-How related to the
Compounds that is not specific for any Product but is necessary to manufacture, develop or evaluate any Product in accordance
with the terms of this Agreement, in each case, solely to discover, develop, make, have made, import, export, use, offer for sale
and sell, and otherwise commercialize any Product in the Field in the Territory.

 

6.2
Right to Sublicense. The rights granted to Provention in section 6.1 include the right to grant sublicenses; provided
that any such sublicense obliges the sublicensee to comply with all the terms of this agreement (except those provisions which,
by their clear meaning, are not applicable to a sublicense) and that Provention remains liable to Janssen for all material acts
and omissions of any such sublicensee.

 

6.3
No Implied Licenses. Only those licenses expressly granted in this agreement have effect. No license or other intellectual
property interest is granted by implication or any method that is not express.

 

6.4
No Implied Limitation. Except as expressly stated in section 6.1, the rights and obligations under the License Grant do not
limit Janssen’s interests in the Compound. To be clear, Janssen remains free to conduct research on and commercialize Compounds
and Products for indications outside of the Field, without the consent of, or accounting to, Provention; provided, however, that
Janssen shall consult with Provention with respect to any Development, Commercialization or other activity related to the Compound
that could reasonably be expected to affect Provention in its use of the Compound in the Field.

 

    	 	16	 

     

    

 

ARTICLE
7: CONFIDENTIALITY AND PUBLICATION

 

7.1
Nondisclosure Obligation. All Confidential Information disclosed by one Party to the other Party will be maintained in confidence
by the receiving Party and the receiving Party will not disclose it to a Third Party except to the extent that such Confidential
Information is:

 

	 	a)	information
    which, at the time of disclosure is published, known publicly or is otherwise in the public domain; or
	 	 	 
	 	b)	information
    which, after disclosure, is published or becomes known publicly or otherwise becomes part of the public domain, through no
    fault of the receiving Party; or
	 	 	 
	 	c)	information
    which, prior to the time of disclosure, is known to the receiving Party, as evidenced by its written records; or
	 	 	 
	 	d)	information
    which has been or is disclosed to the receiving Party in good faith by a Third Party who was not, or is not, under any obligation
    of confidence or secrecy to the disclosing Party at the time the Third Party discloses it to the receiving Party; or
	 	 	 
	 	e)	disclosed
    to governmental or other regulatory agencies to comply with applicable law or regulations, provided the receiving Party
    or its Affiliate provides to the disclosing Party prompt prior written notice of its obligation to make such disclosure and
    takes reasonable and lawful actions to avoid or minimize the degree of such disclosure; or 
	 	 	 
	 	f)	to
    the extent it is deemed necessary by Provention or its Affiliate, in its reasonable judgment, to be disclosed to any Third
    Party for the research and Development, Manufacturing and/or Commercialization of a Product (or for such entities to determine
    their interest in performing such activities) in accordance with this agreement.

 

Any
combination of features or disclosures will not fall within the foregoing exclusions merely because individual features are published
or available to the general public or in the rightful possession of the receiving Party unless the combination itself and principle
of operation are published or available to the general public or in the rightful possession of the receiving Party.

 

If
a Party is required by judicial or administrative process to disclose Confidential Information that is subject to the non-disclosure
provisions of this section 7.1, such Party shall promptly inform the other Party of the disclosure that is being sought in order
to provide the other Party an opportunity to challenge or limit the disclosure obligations. Confidential Information that is disclosed
by judicial or administrative process remains otherwise subject to the confidentiality and non-use provisions of this section
7.1, and the receiving Party shall cooperate with any reasonable attempts of the disclosing Party to limit the disclosure required
by law, including obtaining an order of confidentiality, to ensure the continued confidential treatment of such Confidential Information.

 

Provention
shall limit distribution of any Compound and Product to those personnel of Provention, or its Affiliates or agents, as necessary
or useful to carry out the Study. Provention shall not transfer Compound or Product to Third Parties other than its Affiliates
or agents without Janssen’s prior approval.

 

    	 	17	 

     

    

 

7.2
Publication.

 

	 	7.2.1	A
    Party, its employees or consultants wishing to publish or publicly present any information about a Product or the results
    of any activities to Develop a Product shall deliver to the other Party a copy of the proposed written publication or an outline
    of an oral disclosure at least thirty (30) days prior to submission for publication or presentation. The reviewing Party shall
    notify the other Party within thirty (30) days of receipt of the proposed publication whether the draft publication contains
    (i) information that is Confidential to the reviewing Party, (ii) information that if published would have an adverse effect
    on a patent application covering the subject matter of this agreement, or (iii) any other information or content that the
    reviewing Party wishes to comment on. The reviewing Party will propose modifications to the publication or presentation for
    patent reasons, confidentiality reasons or request a reasonable delay in publication or presentation in order to protect patentable
    information. If the reviewing Party requests a delay to protect patentable information, the other Party shall delay submission
    or presentation for a period not to exceed ninety (90) days to enable relevant patent applications to be filed. Upon expiration
    of such ninety (90) days, such Party will be free to proceed with the publication or presentation. If the reviewing Party
    reasonably requests modifications to the publication or presentation to prevent disclosure of trade secret or proprietary
    business information, the other Party shall edit such publication to prevent the disclosure of such information prior to submission
    of the publication or presentation. If the reviewing Party reasonably requests modifications for any reason other than those
    stated in (i) and (ii) above, the Party wishing to publish or publicly present such publication or presentation shall consider
    the reviewing Party’s proposed modifications in good faith and shall not unreasonably reject input and comments of the
    reviewing Party.
	 	 	 
	 	7.2.2	Once
    a publication or presentation has been approved, the Parties may use the information contained in the publication or presentation
    without seeking further approval. 
	 	 	 
	 	7.2.3	The
    Parties will ascribe authorship of any proposed publication using accepted standards used in peer-reviewed, academic journals
    at the time of the proposed publication. 

 

7.3
Publicity/Use of Names. Except as provided above, neither Party will disclose the existence of this agreement or its terms
nor shall they use the name, trademark, trade name or logo of the other Party or its employees in any publicity, news release
or promotional materials relating to this agreement or its subject matter, without the prior express written permission of the
other Party, except as may be required by applicable laws, regulations, or judicial order. The Party desiring to make the public
announcement shall provide the other Party with a written copy of the proposed announcement in sufficient time prior to public
release to allow comment upon such announcement, prior to public release.

 

    	 	18	 

     

    

 

ARTICLE
8: PAYMENTS

 

	8.1	Milestone
    Payments.
	 	 
	8.1.1	Provention
    shall pay to Janssen one time only each of the amounts set forth in this section 8.1.1 (each, a “Milestone Payment”)
    if such corresponding milestone event (each, a “Milestone Event”) is achieved by Provention or its Related
    Parties (including sublicensees) with a Product.

 

(a)
Development Milestone Events 1st Indication

 

	 	 	 	Milestone
    Event	 	Milestone

                                                      Payment
                                         (USD)

	 	 	 	 	 	1st
    Indication
	 	1	 	 	First
    dosing of the fifth patient in a pivotal Phase 3 Clinical Trial for a Product	 	$	[*****]
	 	2	 	 	First
    FDA approval of a Product in the US for any indication	 	$	[*****]
	 	3	 	 	First
    MAA Approval of a Product for any indication	 	$	[*****]
	 	4	 	 	First
    approval of a Product in Japan for any indication	 	$	[*****]

 

(b)
Development Milestone Events 2nd Indication

 

If
Provention develops a Product for a 2nd Indication, then Provention will pay Janssen the additional Milestone Payment for each
Development Milestone Event achieved by Provention or its Related Parties (including sublicensees) for such 2nd Indication, as
set forth in this section 8.1.1(b).

 

	 	 	 	Milestone
    Event	 	Milestone

                                                       Payment
                                         (USD)

	 	 	 	 	 	2nd
    Indication
	 	1	 	 	First
    FDA approval of a Product in the US for the 2nd Indication	 	$	[*****]
	 	2	 	 	First
    MAA Approval of a Product for the 2nd Indication	 	$	[*****]
	 	3	 	 	First
    approval of a Product in Japan for the 2nd Indication	 	$	[*****]

 

    	 	19	 

     

    

 

(c)
Commercial Milestone Events

 

	 	 	 	Milestone
    Event	 	Milestone

                                                      Payment
                                         (USD)

	 	1	 	 	First
    calendar year in which annual worldwide Net Sales of all Products exceed $[*****]	 	$	[*****]
	 	2	 	 	First
    calendar year in which annual worldwide Net Sales of all Products exceed $[*****]	 	$	[*****]
	 	3	 	 	First
    calendar year in which annual worldwide Net Sales of all Products exceed $[*****]	 	$	[*****]

 

	 	8.1.2	Maximum
                                         Milestone Payments. 

 

Milestone
Payments are payable only once upon the initial achievement of the associated Milestone Event. Provention shall promptly provide
Janssen with written notice upon the achievement of each of the Milestone Events and will pay each associated Milestone Payment
within sixty (60) days after achievement of the Milestone Event in the case of Milestone Events in sections 8.1.1(a) and 8.1.1(b)
and within sixty (60) days of the end of the Calendar Year in the case of Milestone Events in section 8.1.1(c). If more than one
Milestone Event occurs in the same Calendar Year, then Provention will need to pay the Milestone Amount for each of the Milestone
Events in such Calendar Year. For example, if in a Calendar Year the Net Sales have increased from $[*****]to $[*****]then Provention
would make a Milestone Payment to Janssen of $[*****]. If Janssen believes any Milestone Payment is due in spite of not having
received notice from Provention, it will so notify Provention and provide to Provention the data and information supporting its
belief. Provention will have thirty (30) days after receipt of the data and information from Janssen to address Janssen’s
notification. If upon receipt of Provention’s answer to Janssen’s notification, Janssen still believes such Milestone
Payment is due it may use the procedure set forth in section 12.8.1 to resolve the issue.

 

    	 	20	 

     

    

 

8.2
Royalties. Provention shall pay to Janssen royalties on the Net Sales of Products as set out in this section 8.2.

 

	 	8.2.1	Royalty Rates.

 

	 	(a)	Royalties
    Payable. Provention will pay Janssen royalties on aggregate Net Sales by Provention or its
    Related Parties (including sublicensees) of all Products in each Calendar Year at the royalty rates set out below. The period
    in which royalties are payable for Product sales in a given country ends upon the later to occur of (i) ten (10) years from
    the initial First Commercial Sale of a Product in the country or (ii) expiration of the last-to-expire Valid Claim within
    either the Janssen Patent Rights or Joint Patent Rights that is issued in such country of sale and, but for the licenses granted
    herein, would be infringed by such sale of such Product. 

 

	 
Calendar
                                         Year Net Sales
	 	 	Royalty

                                                                                Rate
                                         (%)
	 
	For
    aggregate Net Sales in a Calendar Year of all Products less than or equal to [*****] U.S. Dollars (US$[*****])	 	 	[*****]%	 
	For
    the portion of aggregate Net Sales in a Calendar Year of all Products greater than [*****] U.S. Dollars (US$[*****]) but less
    than or equal to [*****] U.S. Dollars (US$[*****])	 	 	[*****]%	 
	For
    the portion of aggregate Net Sales in a Calendar Year of all Products greater than [*****] U.S. Dollars (US$[*****])	 	 	[*****]%	 

 

By
way of example, if aggregate Net Sales in a Calendar Year of all Products are $[*****],
the royalties due under this section 8.2.1(a) would be $[*****], calculated as follows:
$[*****] royalty on the first $[*****] of Net
Sales plus $[*****] royalty on the remaining $[*****] of
Net Sales. By way of further example, if aggregate Net Sales in a Calendar Year of all Products are $[*****],
the royalties due under this section 8.2.1(a) would be $[*****], calculated as follows:
$[*****] royalty on the first $[*****] of Net
Sales, plus $[*****] on the Net Sales greater than $[*****] but
up to $[*****], plus $[*****] on the remaining
$[*****] of Net Sales. 

 

	 	(b)	Royalty
    Reduction. In the event that one or more patent licenses from Third Parties are required by Provention in order to make,
    have made, use, offer to sell, sell or import a Product in the Field in a country (“Third Party Licenses”), [*****]
    percent ([*****]%) of the royalties actually paid by Provention under such Third Party Licenses for the sale of such Product
    in such country for a calendar quarter shall be creditable against the royalty payments due Janssen by Provention with respect
    to Net Sales of such Product in such country; provided, however, that in no event shall the royalties otherwise owed by Provention
    to Janssen for such calendar quarter in such country be reduced by more than [*****] percent ([*****]%).

 

    	 	21	 

     

    

 

8.2.2
Other Royalty Provisions. All royalties are subject to the following conditions:

 

	 	(a)	only
    one royalty will be due with respect to the same unit of a Product. No multiple royalty will be payable based on being covered
    by more than one Valid Claim;
	 	 	 
	 	(b)	no
    royalties will be due upon the sale or other transfer among Provention or its Related Parties; and
	 	 	 
	 	(c)	no
    royalties will be due on the disposition of a Product by Provention or its Related Parties in reasonable quantities provided
    as samples (promotional or otherwise) or as donations (for example, to non-profit institutions or government agencies for
    a non-commercial purpose).

 

8.3
Additional Sublicensing Compensation. In the event that Provention grants a sublicense under section 6.2 either (a) prior
to the first dosing of the fifth (5th) patient in a pivotal Phase 2b trial, or (b) prior to the first dosing of the
fifth (5th) patient in a pivotal Phase 3 trial then, in addition to the Milestone Payments and Royalties due under
sections 8.1 and 8.2, Provention shall also pay Janssen either [*****] percent ([*****]%), or [*****] percent ([*****]%), respectively,
of all compensation received by Provention from the sublicensee that is in excess of the foregoing Milestone Payments and Royalties,
provided that such obligation shall not apply to any amounts received as support for research and development activities, as a
loan, for the purchase of an equity interest in Provention, as reimbursement for patent costs, as earned royalties on sales, or
as consideration for the grant of rights to intellectual property and/or materials that are not claimed by the Janssen Patent
Rights.

 

8.4
Reports and Payments. During the term of this agreement following the First Commercial Sale of a Product in any country, Provention
shall furnish to Janssen a quarterly written report, as of the end of each Calendar Quarter, showing (i) the Net Sales of each
Product in each country in the world during the reporting period; (ii) the royalties payable under this agreement on account of
those Net Sales and the basis for calculating those royalties; and (iii) the exchange rates and other methodology used in converting
into U.S. Dollars, from the currencies in which sales were made, any payments due which are based on Net Sales. Provention will
provide such reports to Janssen no later than the twentieth (20th) day following the last day of each Calendar Quarter.
Royalties shown to have accrued by each royalty report are due and payable to Janssen on the fortieth (40th) day following
the end of such Calendar Quarter. Provention will keep complete and accurate records in sufficient detail to enable the royalties
payable to be determined and the information provided to be verified by Janssen’s accounting firm pursuant to section 8.5.

 

8.5
Audits. Upon the written request of Janssen, with sixty (60) days prior written notice to Provention, and not more than once
in each Calendar Year, Provention shall permit an independent certified public accounting firm selected by Janssen and reasonably
acceptable to Provention, at Janssen’s expense, to have access during normal business hours to such of the records of Provention
and its Affiliates as may be reasonably necessary to verify the accuracy of the royalty reports hereunder. Those records will
include gross sales of each Product on a country-by-country basis, as well as all deductions taken from gross sales in that country
to arrive at Net Sales in that country, though, depending upon Provention’s then-current reporting practices for financial
information, country-by-country data may only be accessible on an in-country basis from Provention’s Affiliates. Janssen
will instruct the accounting firm to disclose to Janssen only whether the royalty reports are correct or incorrect and the specific
details concerning any discrepancies.

 

    	 	22	 

     

    

 

If
such independent accountant’s review of Provention’s royalty reports shows an underpayment, Provention shall remit
or cause its Related Parties to remit to Janssen within sixty (60) days after Provention’s receipt of the report: (a) the
amount of such underpayment, and (b) if such underpayment exceeds five percent (5%) of the total amount owed for the period being
audited, the reasonable and necessary fees and expenses of the independent accountant performing the audit. Any overpayments will
be credited against amounts payable in the immediately subsequent payment period(s). To the extent that a subsequent payment period
does not exist, Janssen shall remit or cause its Affiliates to remit the amount of such overpayment to Provention within sixty
(60) days after Provention’s receipt of the report.

 

Janssen
shall treat all financial information subject to review or under any sublicense agreement in accordance with the confidentiality
and non-use provisions of this agreement, and shall cause its accounting firm to enter into a reasonably acceptable confidentiality
agreement with Provention and/or its Related Parties obligating it to retain all such information in confidence.

 

8.6
Income Tax Withholding.

 

	 	8.6.1	Provention
    will make all payments to Janssen under this agreement without deduction or withholding for Taxes except to the extent that
    any such deduction or withholding is required by law in effect at the time of payment.
	 	 	 
	 	8.6.2
    	Any
    Tax required to be withheld on amounts payable under this agreement will be paid by Provention on behalf of Janssen to the
    appropriate governmental authority, and Provention will furnish Janssen with proof of payment of such Tax. Any such Tax required
    to be withheld will be an expense of and borne by Janssen. If any such Tax is assessed against and paid by Provention, then
    Janssen will indemnify and hold harmless Provention from and against such Tax.
	 	 	 
	 	8.6.3	Provention
    and Janssen will cooperate with respect to all documentation required by any taxing authority or reasonably requested by Provention
    to secure a reduction in the rate of applicable withholding Taxes. On the date of execution of this agreement, Janssen will
    deliver to Provention an accurate and complete Internal Revenue Service Form W-8BEN-E certifying that Janssen is entitled
    to the applicable benefits under the Income Tax Treaty between Belgium and the United States. 

 

	8.7	Currency
    Restrictions. If restrictions on the transfer of currency exist in any country such as to prevent Provention from making
    the payments in the currency required under section 8.10, Provention shall take all reasonable steps to obtain a waiver of
    such restrictions or otherwise enable Provention to make such payments, failing which Provention may make the royalty payments
    due upon sales in such country in local currency and deposit such payments in a local bank or other depository designated
    by Janssen.

 

    	 	23	 

     

    

 

	8.8	Expiration
    of Royalty Obligations. Provention retains a nonexclusive license in the Territory to make, use, sell, import and have
    such acts performed for Provention’s benefit following expiration of all royalty obligations in respect of any Product.
	 	 
	8.9	Interest.
    In case of any delay in payment by Provention to Janssen not resulting from Force Majeure (as described in section 12.2),
    interest at the annual rate of one-twelfth (1/12) of the Prime Rate (as reported by JP Morgan Chase & Co.) plus one percent
    (1%) assessed from the thirty-first (31st) day after the due date of the payment shall be due from Provention.
    
	 	 
	8.10	Payments.
    All payments to be made by Provention to Janssen under this agreement shall be made in US Dollars and shall be paid by
    bank wire transfer in immediately available funds to such bank account in the United States or elsewhere as may be designated
    in writing by Janssen from time to time.
	 	 
	8.11	Currency.
    With respect to sales of Product in the Field in the Territory reported in a currency other than U.S. Dollars, such amounts
    and the amounts payable hereunder shall be expressed in U.S. Dollar equivalent calculated using the average for the applicable
    J&J Calendar quarter of the daily closing rate as published daily on Bloomberg.

 

ARTICLE
9: REPRESENTATIONS AND WARRANTIES

 

9.1
Representations and Warranties of Janssen. Janssen represents and warrants to Provention that as of the Effective Date:

 

	 	9.1.1	Authorization.
    This agreement has been duly executed and delivered by Janssen and constitutes the valid and binding obligation of Janssen,
    enforceable against Janssen in accordance with its terms. The execution, delivery and performance of this agreement have been
    duly authorized by all necessary action on the part of Janssen, its officers and directors.
	 	 	 
	 	9.1.2	Ownership
    of Intellectual Property; Non-misapropriation. Janssen has full right and interest in all Janssen Patent Rights. To the
    best of its knowledge, as of the Effective Date, Janssen represents and warrants that (i) any Patent Rights, Know-How or other
    intellectual property right owned or controlled by Janssen is not currently being infringed by any Third Party and (ii) the
    practice of such rights does not infringe any property right of any Third Party.
	 	 	 
	 	9.1.3	No
    Patent Proceedings. The Janssen Patent Rights are not the subject of any Patent Proceeding known to Janssen, and Janssen
    is not aware of any pending or threatened action, suit, proceeding or claim by a Third Party challenging Janssen’s ownership
    rights in, or the validity or scope of, such Janssen Patent Rights or Janssen Know-How.
	 	 	 
	 	9.1.4	Janssen
    Patent Rights: Schedule 3 contains a complete list of all Patent Rights Controlled by Janssen, as of the Effective Date,
    that claim JNJ-40346527 or processes for making JNJ-40346527 or using JNJ-40346527 in the Field, or compositions containing
    the same. Such Schedule 3 shall be updated from time-to-time by the Parties.

 

    	 	24	 

     

    

 

9.2
Representations and Warranties of Provention. Provention represents and warrants to Janssen that as of the Effective Date:

 

	 	9.2.1	Authorization.
    This agreement has been duly executed and delivered by Provention and constitutes the valid and binding obligation of
    Provention, enforceable against Provention in accordance with its terms. The execution, delivery and performance of this agreement
    have been duly authorized by all necessary action on the part of Provention, its officers and directors.

 

ARTICLE
10: PATENT PROVISIONS

 

10.1
Ownership of IP, and Filing, Prosecution and Maintenance of Patents

 

	 	10.1.1	Newly
    developed Patent Rights, know-how, information, results, or other intellectual property relating to Compounds or Products
    created during the term of this Agreement or in performance of the Study (“New IP”) shall, whether or not patentable,
    be owned according to inventorship as determined under United States patent laws. For the sake of clarity, New IP created
    solely by Provention and its Affiliates and their respective employees (“Provention New IP”) shall be owned by
    Provention; New IP created solely by Janssen and its Affiliates and their respective employees (“Janssen New IP”)
    shall be owned by Janssen; and New IP created by both Provention and Janssen (or their respective Affiliates, and their employees)
    shall be jointly owned by Provention and Janssen (“Joint IP”).
	 	 	 
	 	10.1.2	For
    all Provention New IP that relates to Compounds or Products, including to the use or formulation of Compounds or Products,
    Provention agrees to grant and hereby grants to Janssen a non-exclusive, sublicensable, irrevocable, royalty-free license
    under such Provention New IP, including any Patent Rights thereon, to Develop and Commercialize Compounds and Products outside
    of the Field.
	 	 	 
	 	10.1.3	Each
    Party shall solely control and be responsible for (at its own expense) the filing, prosecution, maintenance, defense, and
    enforcement of Patent Rights on New IP that it solely owns. However, each Party will consult with the other on all such matters,
    including by providing the other Party an opportunity to review drafts of new patent applications and responses prior to filing,
    and shall not unreasonably reject input and comments of the other Party. Unless otherwise agreed by both Janssen and Provention,
    even in the event the Buy-Back Option of section 4.1 is not exercised, Janssen will continue to control and be responsible
    for (at its own expense) the prosecution, maintenance, defense and enforcement of Janssen Patent Rights; provided, however,
    that Janssen shall consult with Provention with respect to the prosecution, maintenance defense and enforcement of Janssen
    Patent Rights, and Janssen shall consider Provention’s input in good faith and shall not unreasonably reject input of
    Provention.

 

    	 	25	 

     

    

 

	 	10.1.4	The
    Parties will agree on who shall file, prosecute, and maintain any Patent Rights on Joint IP, and will share equally in all
    costs associated therewith. A Party planning on filing any priority-establishing or original (in each case, with respect to
    any claims or new matter described in the patent specification) patent application, or any substantive response during prosecution
    of any application or patent within the Patent Rights on Joint IP shall use reasonable efforts to provide to the other Party,
    with reasonable advance time such as at least thirty (30) days prior to proposed filing in a Patent Office (such as a draft
    application or response to an official action), and provide the other Party an opportunity to comment thereon through its
    respective patent counsel. Each Party shall provide to the other, promptly after filing, a copy of each priority-establishing
    or original (whether provisional or nonprovisional) patent application within the Patent Rights on Joint IP as filed in the
    Patent Office and each other substantive prosecution filing (including any other patent application filed within the Patent
    Rights on Joint IP). 
	 	 	 
	 	10.1.5	Any
    Janssen New IP and Janssen’s interest in Joint IP that contains a Valid Claim will be included in, and considered a
    part of, the Janssen Patent Rights.

 

10.2
Option to Prosecute and Maintain Patents. If: (a) Janssen decides to abandon any Janssen Patent Rights while Provention is
licensed under those Janssen Patent Rights; or (b) Provention decides to abandon any Patent Rights on Provention New IP, then,
prior to such abandonment, the Party desiring to abandon shall first provide the other Party with notice within a reasonable amount
of time prior to the next action item required to maintain such Patent Rights, offering to assign to the other Party its rights
to such Patent Rights. If the other Party accepts, such Patent Rights shall thereafter be assigned, and any further costs related
to the maintenance or prosecution of the assigned Patent Rights will be borne by the assignee.

 

10.3
Enforcement and Defense.

 

	 	10.3.1	Each
    Party shall promptly give the other Party notice of (i) any infringement of Janssen Patent Rights or Joint Patent Rights,
    or (ii) any misappropriation or misuse of Janssen Know-How, that may come to a Party’s attention. Provention and Janssen
    shall thereafter cooperate to determine a course of action to terminate any infringement of Janssen Patent Rights or Joint
    Patent Rights or any misappropriation or misuse of Janssen Know-How. Provention has the right but not the obligation, within
    the Field, to initiate and prosecute any such legal action at its own expense and in the name of Janssen and Provention (or
    just Janssen or just Provention if the laws of the jurisdiction so dictate), or to control the defense of any declaratory
    judgment action relating to Janssen Patent Rights, Joint Patent Rights, or Janssen Know-How in the Field. The costs of any
    legal action commenced or the defense of any declaratory judgment shall be borne by Provention, but only to the extent Provention
    has exercised its right pursuant to the immediately preceding sentence. Provention shall promptly inform Janssen if it elects
    not to exercise that right with respect to Janssen Patent Rights or Joint Patent Rights and Janssen shall thereafter have
    the right at its sole cost to either initiate and prosecute such action or to control the defense of such declaratory judgment
    action in the name of Provention and, if necessary, Janssen. Each Party shall have the right to be represented by counsel
    of its own choice. 

 

    	 	26	 

     

    

 

	 	10.3.2	For
    any action to terminate any infringement of Janssen Patent Rights or Joint Patent Rights or any misappropriation or misuse
    of Janssen Know-How, if Provention is unable to initiate or prosecute such action solely in its own name, Janssen shall join
    such action voluntarily and shall execute and cause its Affiliates to execute all documents necessary for Provention to initiate
    litigation to prosecute and maintain such action. Each Party shall bear its own costs in such instance. In connection with
    any action, Provention and Janssen shall cooperate fully and shall provide each other with any information or assistance that
    either may reasonably request. Each Party shall keep the other informed of developments in any action or proceeding, including,
    to the extent permissible by law, the consultation and approval of any settlement negotiations and the terms of any offer
    related thereto.
	 	 	 
	 	10.3.3	Any
    recovery obtained by either or both Provention and Janssen in the Field in connection with or as a result of any action contemplated
    by this section, whether by settlement or otherwise, shall be shared in order as follows:

 

	 	(a)	the
    Party that initiated and prosecuted the action will recoup all of its costs and expenses incurred in connection with the action;
	 	 	 
	 	(b)	the
    other Party will then, to the extent possible, recover its costs and expenses incurred in connection with the action; and
	 	 	 
	 	(c)	The
    amount of any recovery remaining will be allocated as follows:

 

(i)
if the recovery is based upon Provention’s lost sales or profits, then Provention shall pay to Janssen the same royalties
as set forth in Article 8 calculated on the Net Sales which formed the basis of Provention’s lost profits claim; and

 

(ii)
if the recovery is based upon the allocation of a reasonable royalty, then the Party that initiated and prosecuted the action
shall receive seventy-five percent (75%) of such recovery, and the remaining twenty-five percent (25%) shall be allocated to the
other Party.

 

	 	10.3.4	Third
    Party Claims.

 

	 	(a)	Without
    prejudice to section 12.1.2, if any action, suit or proceeding is brought against Provention or Janssen or any Affiliate or
    sublicensees of either Party alleging the infringement of the intellectual property rights of a Third Party by reason of the
    discovery, development, manufacture, use, sale, importation or offer for sale of a Product in the Territory, each of the Parties
    shall have the right but not the obligation to defend itself in such action, suit or proceeding at its sole expense. The Parties
    shall cooperate with each other in any defense of any such suit, action or proceeding. The Parties shall give each other prompt
    written notice of the commencement of any such suit, action or proceeding, or receipt of any claim of infringement, and shall
    furnish each other a copy of each communication relating to the alleged infringement. 

 

    	 	27	 

     

     

	 	 	Neither
    Party shall compromise, litigate, settle or otherwise dispose of any such suit, action or proceeding without the other Party’s
    advice and prior consent, provided that the Party not having the right to defend the suit shall not unreasonably withhold
    its consent to any settlement which does not have a material adverse effect on its rights, obligations or benefits, either
    under this agreement or otherwise. Notwithstanding the foregoing, Provention may seek to obtain a license from the Third Party
    at its sole cost and expense, provided that the terms and conditions of such license do not include an admission of
    invalidity of any Janssen Patent Rights or Joint Patent Rights, or restrict Janssen’s ability to challenge or litigate
    the validity or applicability of any intellectual property to which the license relates.
	 	 	 
	 	(b)	The
    Party first having actual notice of any claim, action or proceeding referenced in section 10.3.4(a) above shall promptly notify
    the other Party in writing, setting forth in reasonable detail, to its knowledge, the facts related to any such claim, action
    or proceeding. The Parties shall promptly discuss proposed responses to any such matters.

 

ARTICLE
11: TERM AND TERMINATION

 

11.1
Term and Expiration. This agreement is effective as of the Effective Date and unless terminated earlier pursuant to sections
11.2, 11.3 or 11.7, will continue in effect until expiration of all royalty obligations under Article 8 or Article 4 if the Option
of Article 4 has been exercised (the “Term”). Upon expiration (but not termination) of this agreement: (a) if the
Option of Article 4 has not been exercised, Provention shall have a fully paid-up license under Janssen Know-How and Janssen Patent
Rights to make, have made, use, sell, have sold, and import Products in the Field; (b) if the Option of Article 4 has been exercised,
Janssen shall have a fully paid-up license under Provention New IP and Patent Rights thereon to make, have made, use, sell, have
sold, and import Products in the Field; and (c) Janssen shall have a fully paid-up, non-exclusive license under Provention New
IP and Patent Rights thereon to make, have made, use, sell, have sold, and import Products outside of the Field.

 

11.2
Termination by Provention Without Cause.

 

	 	11.2.1	Except
    with respect to Janssen’s licenses under sections 4.2(b) and 10.1.2, Provention has the right to terminate this agreement
    in its entirety at any time and in its sole discretion upon ninety (90) calendar days advance written notice to Janssen, except
    that Provention will wind down any on-going clinical trial consistent with applicable law if a Product has received a Regulatory
    Approval in any Major Market Country; 
	 	 	 
	 	11.2.2	Provention
    has the right to terminate this agreement immediately in its sole discretion upon written notice to Janssen if a Valid Safety
    Issue exists. The notice will provide sufficient information for Janssen to confirm the existence of the Valid Safety Issue.
    A “Valid Safety Issue” means the ceasing of Development activities or withdrawal from any market as a result
    of reasonable concerns that the Product is unsafe for administration to humans. During the period of notice until the effective
    date of termination, Provention will not be required to (i) initiate any new clinical or non-clinical studies, (ii) make any
    further filings for Regulatory Approval other than as related to the prompt and complete transfer of regulatory authorizations
    and Development and Commercialization rights to Janssen, or (iii) launch the Product in any further countries.

 

    	 	28	 

     

     

 

11.3
Termination for Cause. This agreement may be terminated at any time during the term of this agreement:

 

	 	11.3.1	upon
    written notice by either Party if the other Party is in material breach of its obligations hereunder and has not cured such
    breach after notice from the terminating Party requesting cure of the breach as specified below; provided, however,
    in the event of a good faith dispute with respect to the existence of a material breach, the cure period is tolled until such
    time as the dispute is resolved pursuant to section 12.8; and provided that the terminating Party has given the defaulting
    Party the following opportunities to remedy any breach: 

 

	 	(a)	the
    written notice of breach referenced will detail the specific obligation under this agreement which is alleged to have been
    breached; the manner of such alleged breach; and the steps which must be taken in order to remedy such breach; and
	 	 	 
	 	(b)	the
    terminating Party has provided the defaulting Party with a reasonable amount of time (but no more than ninety (90) days) in
    which (i) to complete any steps which might be taken to remedy the breach, as stated in the notification of breach, or (ii)
    if completion of those steps is not possible within a ninety (90) day period, to commence those steps required as stated in
    the notification of breach, on the condition that the defaulting Party continues to perform those steps with due diligence
    and the breach can be cured within a mutually agreeable reasonable period of time.

 

11.4
Effect on License of Termination by Provention for Cause. If Provention terminates this agreement under section 11.3.1, then
(i) Provention’s licenses pursuant to Article 6 become perpetual exclusive licenses subject to the financial provisions
of Article 8; and (ii) Provention has the right to offset against any monies owed to Janssen (pursuant to Article 8 of this agreement)
all of its direct costs, losses and expenses incurred as a result of Janssen’s breach. In addition, within ninety (90) days
after such termination, Janssen shall return or destroy, subject to Provention’s written instructions, all Provention Confidential
Information including Provention Know-How in its possession.

 

11.5
Effect of Termination by Janssen For Cause or by Provention Without Cause. If Janssen terminates this agreement under section
11.3 or Provention terminates this agreement under section 11.2, the licenses granted to Provention terminate as of the agreement
termination date and Provention shall, within thirty (30) days of the termination date, remit to Janssen all outstanding monies
owed to Janssen at the time of such termination. In addition, within ninety (90) days after such termination, Provention shall:

 

    	 	29	 

     

     

	 	(a)	Return
    to Janssen or destroy, subject to Janssen’s written instructions, all Compound that it has in its possession, even if
    such is in the form of a Combination Product; and 
	 	 	 
	 	(b)	Return
    or destroy, subject to Janssen’s written instructions, all documents containing Janssen Confidential Information, including
    Janssen Know-How in its possession. To the extent Janssen instructs that the documents should be destroyed, Provention shall
    certify to Janssen that such destruction has occurred.

 

11.6
Effect on Licenses of Termination by a Licensee For Bankruptcy. All rights and licenses granted to a licensee Party under
this agreement are licenses of rights to intellectual property as defined in the bankruptcy laws of the United States and, to
the extent permitted by law, will have the same effect in other jurisdictions. If an action in bankruptcy or insolvency is commenced
by or against a licensor Party and the bankruptcy trustee, receiver, or other party assigned to oversee the disposition of the
estate of the licensor Party rejects the further execution of the licensor Party’s obligations, the licensee Party retains
its rights to operate under the licenses granted to it. In addition to the rights, powers and remedies expressly provided in this
agreement, the licensee Party is entitled to exercise all other rights and powers and resort to all other remedies that exist
at law or in equity in such event.

 

No
termination of this agreement under section 11.2 or 11.3 will terminate any valid sublicense and each sublicensee will be a direct
licensee of Janssen, provided that (a) all accrued payment obligations to Provention have been paid, and (b) such sublicensee
agrees in writing to assume all applicable obligations of Provention under this agreement.

 

11.7
HSR Filing; Termination Upon HSR Denial. If Provention and Janssen determine that an HSR filing is necessary, each of Janssen
and Provention shall, within five (5) days of the Effective Date (or such later time as may be agreed to in writing by the Parties),
file with the United States Federal Trade Commission and the Antitrust Division of the United States Department of Justice, or
with equivalent foreign authorities, any HSR Filing required of it under the HSR Act in the reasonable opinion of either Party.
Each of Janssen and Provention will use Diligent Efforts to do, or cause to be done, all things necessary, proper and advisable
to, as promptly as practicable, take all actions necessary to make the filings required of Janssen and Provention or their respective
Affiliates under the HSR Act. The Parties shall cooperate with one another to the extent necessary in the preparation of any such
HSR Filing. Each Party shall be responsible for its own costs, expenses, and filing fees associated with any HSR Filing; provided,
however, that Provention is solely responsible for any fees (other than penalties that may be incurred as a result of actions
or omissions on the part of Janssen) required to be paid to any governmental agency in connection with making any such HSR Filing
for acquisitions by Provention hereunder. If the Parties make an HSR Filing, then (i) the licenses and rights granted pursuant
to this agreement shall not become effective until the HSR Clearance Date, and (ii) this agreement will terminate (a) at the election
of either Party, immediately upon notice to the other Party, if the U.S. Federal Trade Commission or the U.S. Department of Justice,
or an equivalent authority in the European Union, seeks a preliminary injunction under the antitrust laws against Janssen and
Provention to enjoin the transactions contemplated by this agreement; (b) at the election of either Party, immediately upon notice
to the other Party, in the event that the United States Federal Trade Commission or the United States Department of Justice, or
an equivalent authority in the European Union, obtains a preliminary injunction under the antitrust laws against Janssen and Provention
to enjoin the transactions contemplated by this agreement; or (c) at the election of either Party, immediately upon notice to
the other Party, in the event that the HSR Clearance Date has not occurred on or prior to 180 days after the effective date of
the HSR Filing. In the event that Janssen exercises it right of termination under this section, then Janssen will pay Provention
an amount equal to the sum of the amounts of any upfront fee or milestone payment received by Janssen from Provention hereunder.
For the avoidance of doubt, if Janssen exercises the Option pursuant to section 4.1, the parties acknowledge and agree that each
party shall be responsible for compliance with the HSR Act and other antitrust laws in a manner substantially comparable to the
provisions of this section 11.7.

 

    	 	30	 

     

    

 

11.8
Failure to Obtain Qualified Financing. Should Provention not obtain Qualified Financing, as provided for in Section 2.1 within
7 days of the Effective Date, this Agreement shall automatically terminate and, other than the confidentiality obligations set
forth in Article VII, which shall survive termination, neither Party shall have any further obligation hereunder.

 

11.9
Survival. The provisions of section 4.3.4, 4.4, Article 7, sections 8.8, 11.6, 12.1, 12.7, and 12.8 indefinitely survive any
expiration or termination of this agreement.

 

ARTICLE
12: MISCELLANEOUS

 

12.1
Indemnification.

 

	 	12.1.1	Janssen
    shall indemnify Provention and its Affiliates, and their respective directors, officers, employees and agents, against any
    claims of damages (except to the extent arising from any claims of intellectual property infringement), bodily injury, death,
    or property damage made by a Third Party (a “Third Party Claim”) to the extent arising from: (a) the negligence
    or willful misconduct of Janssen under this agreement; or (b) the material breach by Janssen of any warranty, representation
    or obligation of Janssen under this agreement. This indemnification does not apply to the extent an act or failure to act
    is due to the negligence or willful misconduct of Provention.
	 	 	 
	 	12.1.2	Provention
    shall indemnify Janssen and its Affiliates, and their respective directors, officers, employees and agents, against any Third
    Party Claim to the extent arising from (a) the negligence or willful misconduct of Provention under this agreement; (b) the
    material breach by Provention of any warranty, representation or obligation of Provention under this agreement; or (c) the
    Development, Manufacture, Commercialization or use by Provention or its representatives or agents under this agreement of
    any Product. This indemnification does not apply to the extent an act or failure to act is due to the negligence or willful
    misconduct of Janssen or to the extent Janssen has agreed to provide indemnication with respect to such act or failure pursuant
    to Section 12.1.1.

 

    	 	31	 

     

     

	 	12.1.3	If
    a Party (the “Indemnitee”) intends to claim indemnification under this section, it shall promptly notify
    the other Party (the “Indemnitor”) in writing of any Third Party Claim for which the Indemnitee intends
    to claim such indemnification. The failure of the Indemnitee to deliver written notice to the Indemnitor within a reasonable
    time after the commencement of any such action relieves the Indemnitor of any obligation to the Indemnitee under this section
    with respect to any such action, insofar as the failure prejudices the Indemnitor’s ability to defend a Third Party
    Claim. The Indemnitee shall permit the Indemnitor to control the litigation or settlement of such Third Party Claim, and cooperate
    fully with Indemnitor in all related matters, provided that unless agreed by Indemnitee (a) counsel appointed by Indemnitor
    to defend Indemnitee will not take any position which if sustained would cause Indemnitee not to be indemnified by Indemnitor
    and (b) no settlement will involve any terms binding on Indemnitee except payment of money to be paid by Indemnitor.
	 	 	 
	 	12.1.4	Neither
    Party is liable to the other for indirect, consequential, special or punitive damages under this agreement.

 

12.2
Force Majeure. Neither Party is liable to the other Party nor will it be deemed to have breached this agreement for failure
or delay in performing any obligation under this agreement when such failure or delay is caused by or results from causes beyond
the reasonable control of the affected Party including, but not limited to, embargoes, war, acts of war (whether war be declared
or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire, floods, or other acts of
God, or acts, omissions or delays in acting by any governmental authority or the other Party. The affected Party shall notify
the other Party of such force majeure circumstances as soon as reasonably practical, and shall promptly undertake reasonable efforts
necessary to cure the force majeure circumstances.

 

12.3
Notification of Third Party Bid. At all times prior to the end of the Option Period, Provention will notify Janssen upon receipt
of a Third Party bid to sublicense a Product and must obtain Janssen’s written consent, which shall not be unreasonably
withheld, before granting any such sublicense. Once the Option Period has expired, Provention may grant a sublicense to a Third
Party without Janssen’s consent, provided that: (a) Provention notifies Janssen in writing prior to granting the sublicense;
and (b) the sublicense obliges the sublicensee to comply with the terms of any distribution agreement that the Parties may enter
into pursuant to section 5.2.4.

 

12.4
Assignment. Except as provided in this section 12.4, this agreement may not be assigned or otherwise transferred, nor may
any right or obligation be assigned or transferred, by either Party without the consent of the other Party, except that (i) Janssen
may, without Provention’s consent, assign this agreement and its rights and obligations, in whole or in part, to an Affiliate
and (ii) Provention may, without Janssen’s consent, assign this agreement, in whole or in part, to an Affiliate or in connection
with a Change of Control. Any permitted assignee assumes all obligations of its assignor under this agreement and will be subject
to all of the provisions of this agreement. Any attempted assignment not in accordance with this section is void. In the event
of a permitted Change of Control, Janssen or Provention may, without the other’s consent, assign this agreement and all
rights and obligations to the Change of Control party.

 

12.5
Severability. If any provision in this agreement is held invalid, illegal or unenforceable, the validity, legality and enforceability
of the remaining provisions will not be affected unless the absence of the invalidated provision(s) adversely affects the substantive
rights of the Parties. The Parties will then use reasonable efforts to replace the invalid, illegal or unenforceable provision(s)
with valid, legal and enforceable provision(s) which implement the purposes of this agreement.

 

    	 	32	 

     

     

12.6
Notices. All notices that are required or permitted will be in writing and sufficient if delivered personally, sent by internationally-recognized
courier or sent by registered or certified mail, postage prepaid, transmitted by facsimile, or by email, addressed as follows:

 

	If
    to Janssen, to:	Head,
        External Value Creation

        Janssen
        Research & Development, LLC

        1400
        McKean Road

        Spring
        House, PA 19477

        Email:
        smistry2@its.jnj.com

        

	 	 
	with
    a copy to:	Chief
        Intellectual Property Counsel

        Johnson
        & Johnson

        1
        Johnson & Johnson Plaza

        New
        Brunswick, NJ 08933

        Email:
        jnjuspatent@corus.jnj.com

	 	 
	If
    to Provention, to:	Provention
        Bio, Inc.

        110
        Old Driftway Lane

        Lebanon,
        NJ 0883

        Attn:
        Ashleigh Palmer, President & CEO

        Email:
        apalmer@celimmune.com

	 	 
	with
    a copy to:	Lowenstein
        Sandler LLP

        65
        Livingston Ave.

        Roseland,
        NJ 07068

        Attn:
        Michael J. Lerner, Esq.

        Email:
        mlerner@lowerstein.com

 

or
to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing. Any notice
will have been given: (a) when delivered if personally delivered; (b) on the next business day after dispatch if sent by internationally-recognized
overnight courier by facsimile or email; and/or (c) on the fifth (5th) business day following the date of mailing if
sent by mail or other internationally-recognized courier. Notices are not sufficient if provided only between each Party’s
representatives during the Reporting of section 3.2.

 

12.7
Applicable Law. This agreement is governed by and construed in accordance with the laws of the State of Delaware without reference
to any rules of conflict of laws. The United Nations Convention on the Sale of Goods does not apply to this agreement.

 

    	 	33	 

     

    

 

12.8
Dispute Resolution.

 

12.8.1
Resolution of Disputes: The Parties shall negotiate in good faith and use reasonable efforts to settle any dispute, controversy
or claim arising from or related to this agreement or the breach thereof. If the Parties initially are unable to resolve a dispute
despite using reasonable efforts to do so, either Party may, by written notice to the other, have the dispute referred to their
respective senior management designated below or their respective successors, for attempted resolution by negotiation in good
faith. The attempted resolution will take place no later than thirty (30) days following receipt of such notice. The designated
management (each designated representative, an “Executive Officer”) are as follows:

 

For
Provention: Ashleigh Palmer, President & CEO

 

For
Janssen: Head, External Value Creation

 

If
the Parties are unable to resolve the dispute, controversy or claim within thirty (30) days following the day on which one Party
provides written notice of the dispute to the other in accordance with section 12.8.1, and a Party wishes to pursue the matter,
each such dispute, controversy or claim that is not an Excluded Claim will be finally resolved by mediation followed by binding
arbitration as set forth below. As used in this section, the term “Excluded Claim” means a dispute, controversy
or claim that concerns the validity or infringement of a patent, trademark or copyright.

 

12.8.2
Mediation. The parties shall first attempt in good faith to resolve any Dispute by confidential mediation in accordance with
the then current Mediation Procedure of the International Institute for Conflict Prevention and Resolution (“CPR
Mediation Procedure”) (www.cpradr.org) before initiating arbitration. The CPR Mediation Procedure controls, except where
that Procedure conflicts with these provisions, in which case these provisions control. The mediator will be chosen pursuant to
the CPR Mediation Procedure. The mediation will be held in New York, New York.

 

Either
party may initiate mediation by written notice to the other of the existence of a Dispute. The parties will select the mediator
within twenty (20) days of the notice and the mediation will begin promptly after the selection. The mediation will continue until
the mediator or either party, declares in writing, no sooner than after the conclusion of one full day of a substantive mediation
conference attended on behalf of each party by a senior business person with authority to resolve the Dispute, that the Dispute
cannot be resolved by mediation. In no event, will mediation continue more than sixty (60) days from the initial notice by a party
to initiate meditation unless the parties agree in writing to extend that period.

 

Any
period of limitations that would otherwise expire between the initiation of mediation and its conclusion is extended until twenty
(20) days after the conclusion of the mediation.

 

12.8.3
Arbitration. If the parties fail to resolve the Dispute in mediation, and a party desires to pursue resolution of the Dispute,
the Dispute will be submitted by either party for resolution in arbitration pursuant to the then current CPR Rules for Non-Administered
Arbitration of International Disputes (“CPR Rules”) (www.cpradr.org), except where they conflict with these provisions,
in which case these provisions control. CPR is designated as the Neutral Organization for all purposes. The arbitration will be
conducted in English and held in New York, New York. All aspects of the arbitration will be treated as confidential.

 

    	 	34	 

     

    

 

The
arbitrators will be chosen from the CPR Panels of Distinguished Neutrals, unless a candidate not on the CPR Panel is approved
by both parties. Each arbitrator must be a lawyer with at least fifteen (15) years’ experience with a law firm or corporate
law department of over twenty-five (25) lawyers or who was a judge of a court of general jurisdiction. To the extent that the
Dispute requires special expertise, the parties will so inform CPR prior to the beginning of the selection process.

 

The
arbitration tribunal will consist of three arbitrators, chosen in accordance with Rules 5.3 and 6 of the CPR Rules. If, however,
the aggregate award sought by the parties is less than $5 million and equitable relief is not sought, a single arbitrator will
be chosen in accordance with Rules 5.3 and 6 of the CPR Rules.

 

Candidates
for the arbitrator position(s) may be interviewed by representatives of the parties in advance of their selection, provided that
all parties are represented.

 

The
parties will select the arbitrator(s) within forty-five (45) days of initiation of the arbitration. The hearing will be concluded
within nine (9) months after selection of the arbitrator(s) and the award will be rendered within sixty (60) days of the conclusion
of the hearing, or of any post-hearing briefing, which briefing will be completed by both sides within forty-five (45) days after
the conclusion of the hearing. In the event the parties cannot agree upon a schedule, then the arbitrator(s) shall set the schedule
following the time limits set forth above as closely as practical.

 

The
arbitrator(s) will be guided, but not bound, by the IBA Rules on the Taking of Evidence in International Commercial Arbitration
(www.ibanet.org).

 

The
hearing will be concluded in ten (10) hearing days or less. Multiple hearing days will be scheduled consecutively to the greatest
extent possible. A transcript of the testimony adduced at the hearing will be made available to either party.

 

The
arbitrator(s) shall decide the merits of any Dispute in accordance with the law governing this agreement, without application
of any principle of conflict of laws that would result in reference to a different law. The arbitrator(s) may not apply principles
such as “amiable compositeur” or “natural justice and equity.”

 

The
arbitrator(s) shall render a written opinion stating the reasons upon which the award is based. The arbitrator(s) may award the
costs and expenses of the arbitration as provided in the CPR Rules, but each bears its own attorney fees

 

The
award may be entered and enforced in any court of competent jurisdiction. If a court is called upon to enforce an award in a court
proceeding, the parties consent to the court’s requiring the party resisting enforcement to pay the reasonable attorney’s
fees and costs incurred in that proceeding by the party seeking enforcement.

 

    	 	35	 

     

    

 

Any
party may seek emergency, interim, or provisional relief prior to the appointment of the arbitrator(s) from any court of competent
jurisdiction, without waiver of the agreements to mediate and arbitrate. After appointment of the arbitrator(s), any request for
emergency, interim, or provisional relief shall either be addressed to the arbitrator(s), which shall have the power to enter
an interim award granting relief using the standards provided by applicable law, or to a court, but only with the permission of
the arbitrator(s). Any interim award of the arbitrator(s) may be enforced in any court of competent jurisdiction.

 

EACH
PARTY WAIVES: (1) ITS RIGHT TO TRIAL OF ANY ISSUE BY JURY, (2) WITH THE EXCEPTION OF RELIEF MANDATED BY STATUTE, ANY CLAIM TO
PUNITIVE, EXEMPLARY, MULTIPLIED, INDIRECT, CONSEQUENTIAL OR LOST PROFITS/REVENUES DAMAGES, AND (3) ANY CLAIM FOR ATTORNEY FEES,
COSTS AND PREJUDGMENT INTEREST.

 

12.9
Insurance. Provention agrees to procure and maintain in full force and effect during the term of this agreement valid and
collectible insurance policies, including product liability insurance, in connection with its activities as contemplated under
this agreement, which policies shall cover the activities of Provention, including its employees and agents. Provention shall
provide to Janssen, at Janssen’s request, a certificate of coverage or other written evidence reasonably satisfactory to
Janssen of such insurance coverage.

 

12.10
Entire agreement; Amendments. This agreement, together with the Schedules, contains the entire understanding of the Parties
with respect to the subject matter of this agreement and supersedes and cancels all previous express or implied agreements and
understandings, negotiations, writings and commitments, either oral or written, in respect to the subject matter. This agreement
may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives of both
Parties.

 

12.11
Headings. The captions to the sections and subsections are not a part of this agreement, but are merely for convenience to
assist in locating and reading the sections and subsections.

 

12.12
Independent Contractors. Janssen and Provention are independent contractors with respect to each other and the relationship
between the two Parties is not a partnership, joint venture or agency. Neither Janssen nor Provention has the authority to make
any statements, representations or commitments of any kind, or to take any action, binding on the other Party, without the prior
written consent of the other Party.

 

12.13
Waiver. The waiver by either Party of any right, or the failure of the other Party to perform, or a breach by the other Party,
is not a waiver of any other right or of any other breach or failure by such other Party.

 

12.14
Cumulative Remedies. No remedy referred to in this agreement is intended to be exclusive. Each is in addition to any other
remedy referred to in this agreement or otherwise available under law.

 

    	 	36	 

     

    

 

12.15
Compliance with Laws. The Parties shall comply with all applicable laws, rules, regulations and orders of the United States
and applicable European countries and supra-governmental organizations and all jurisdictions and any agency or court thereof in
connection with this Agreement and the transactions contemplated thereby.

 

12.16
FCPA. In connection with the performance of this Agreement, the Parties will comply with the Foreign Corrupt Practices Act
(“FCPA”) of the U.S.A., laws of the Territory that impose restrictions and obligations in the Territory similar to
those contained therein, and the OECD Convention on Combating Bribery of Foreign Public Officials in International Business Transactions
dated 21 November 1997 as well as any amendments thereto (“Convention”). The Parties will not make any payment or
offers to pay anything of value to any foreign government official in contravention of the FCPA or the Convention. Each Party
warrants that it has not and will not pay or offer, directly or indirectly, any commission or finders or referral fee to any person
or entity in connection with its activities hereunder.

 

12.17
Advice of Counsel. Each Party participated in the drafting of this agreement. In interpreting and applying the terms and provisions
of this agreement no presumption will exist or be implied against the Party that drafted the terms and provisions.

 

12.18
Counterparts. This agreement may be executed in two or more counterparts, each of which is an original, but all of which together
shall constitute one and the same instrument. Electronically signed and/or electronically transmitted signatures shall have the
full force and effect of an original signature.

 

[Signature
Page Follows]

 

    	 	37	 

     

     

IN
WITNESS WHEREOF, the Parties have executed this agreement as of the as of the last date of execution by the parties hereto.

 

	Janssen
    Pharmaceutica NV	 	Provention
    Bio, Inc.
	 	 	 
	By:
    	/s/
    W. Coussement	 	By:	/s/
    Ashleigh Palmer
	Name:	W.
    Coussement	 	Name:	Ashleigh
    Palmer
	Title:	Global
    Head Preclinical Development & Safety	 	Title:	President
    & CEO
	Date: 	4/12/2017	 	Date: 	4/25/2017

 

	By:	Thierry
    Demoncheaux	 
	Name:	Thierry
    Demoncheaux	 
	Title:	Vice
    President	 
	Date:	4/12/2017	 

 

    	 	38	 

     

     

Schedule
1: Transition Plan

 

The
purpose of this Transition Plan is to allow Provention to begin, conduct, and conclude the Study. At a minimum, Janssen will,
promptly after the Effective Date, transfer and/or provide, at reasonable cost to be negotiated between the parties, to Provention:

 

(i)
all Janssen Know-How pertaining to the Compounds;

 

(ii)
the JNJ-40346527 IND/ CTA file or equivalent, including requisite CMC module, and all regulatory correspondence pertaining to
JNJ-40346527;

 

(iii)
any dedicated reagents, assays, or other research tools relevant to the clinical study of the Compounds to enable completion of
the Phase 2a clinical trial;

 

(iv)
any and all other information, documentation, support, assistance and consultancy reasonably necessary, or as reasonably requested
by Provention, to successfully transition and/or transfer the Compounds to Provention and/or Provention’s partners or appointed
subcontractors, including such services and support required to achieve regulatory, ethics and product release approvals for any
Products manufactured by Janssen.

 

In
the event that the Buy-Back Option is not exercised, Janssen will promptly thereafter also provide, at reasonable cost to be negotiated
between the parties, to Provention all technology transfer support and consultancy necessary to reliably set-up the JNJ-40346527
manufacturing process with a Provention contract manufacturing organization or partner.

 

For
the purpose of designing, implementing and interpreting the Study in collaboration with Janssen, Provention will be provided access
to Janssen’s Benchmark Data and Janssen Know-How. Benchmark Data shall include data owned or controlled by Janssen as of
the date when the Study analysis is initiated by Provention relating to the Compounds in the Field, including: i) Crohn’s
disease imaging (e.g., endoscopy), intestinal biopsy tissue and blood biomarkers (e.g., mRNA expression profiles, disease signature
and CSF1R signature); ii) pharmacodynamic markers for JNJ-40346527 (e.g., blood receptor occupancy assay and results) in healthy
volunteers and rheumatoid arthritis patients; and iii) pre-clinical data for CSF1R and JNJ-40346527.

 

Transfer
of Materials. Janssen will, at cost, (i) transfer sufficient inventory of finished JNJ-40346527 active drug product for completion
of the Study according to the plan shown in Schedule 1 (with Janssen making appropriate representations and warranties as to cGMP
compliance); (ii) produce or provide sufficient cGMP inventory of finished JNJ-40346527 matching placebo for completion of the
Study; (iii) provide adequate CMC and quality support and documentation to label, package, release and ship the finished cGMP
active drug product and matching placebo to clinical trial sites and/or a corresponding storage and distribution subcontractor
of Provention’s choice. Provention shall be responsible for all costs associated with the manufacture and shipment of the
aforementioned inventory, but shall not be liable for the cost of manufacturing existing inventory of Compound in Janssen’s
possession.

 

The
Parties may enter into one or more agreements relating to the foregoing, which may include compensation to Janssen for the contemplated
transfers.

 

    	 	39	 

     

     

Schedule
2

 

Preliminary
Clinical Plans for JNJ-40346527 

 

V6
-September 23, 2016

 

 

PROPOSED
STUDY DESIGN FOR A PHASE 2A POM/POC STUDY OF JNJ-40346527 IN CROHN’S DISEASE

 

 

	 	-	BACKGROUND

 

	 	○	CSF-1R
    mediates myeloid cell differentiation in the bone marrow. Its blockade is expected to result in reduction in pro-inflammatory
    macrophages (M1) and inflammatory dendritic cells (DC1) in gut tissue, what would result in amelioration of disease activity
    in IBD, particularly in Crohn’s disease, as the resident myeloid cells die off and are not replaced. The MOA is expected
    to be slower for induction of remission than other therapies, yet possibly more effective at preventing relapse.
	 	○	Hypotheses
    to be tested: 

	 	●	1.
    In the context of inflammation, myeloid blockade will preferentially affect the differentiation of inflammatory myeloid cells
    vs anti-inflammatory myeloid cells, leading to amelioration of inflammation and prevention of relapse.
	 	●	2.
    It is possible that inhibition of CSF-1R may have direct effect on tissue-resident myeloid cells and not just myeloid cell
    differentiation in the bone marrow, what could contribute to efficacy as an induction agent. 

	 	○	JNJ-40346527
    is an oral small-molecule CSF-1R inhibitor which has been shown to be well tolerated yet ineffective in Rheumatoid Arthritis.
    Evidence of target engagement and reduction in myeloid cells in peripheral blood was demonstrated in the Phase 2 RA study.
    Janssen has generated positive pre-clinical data in animal models of IBD (adoptive transfer model). 

 

	 	-	GOAL
    OF THE STUDY

 

	 	○	Conduct
    a Phase 2 “rapid go/no-go” trial in Crohn’s disease to inform the decision whether to take JNJ-40346527
    into full development/Phase 2B. Base decision to move to dose-finding Phase 2B on the totality of the data, including robust
    objective endpoints, in this small signal-finding Phase 2A study.
	 	○	Keep
    study as simple as possible to achieve cost- and time- savings vs standard Phase 2 studies in Crohn’s disease. Conduct
    the study with rigor but cost-effectively, creating a model that could be replicated in the future in similar situations.
	 	○	Consider
    adding elements of future endpoints as long as feasibility is not impacted:

	 	●	Endpoints
    in Crohn’s disease are rapidly evolving and regulatory success will soon be based on a combination of clinical and endoscopic
    endpoints, and not on CDAI as has been the case until now. Collecting data on the new key parameters would add value, though
    it should not jeopardize the goals of the study. 

 

    	 	40	 

     

     

	 	●	FDA
    and EMEA will accept stool frequency (SF) and abdominal pain (AP) as contributing to the clinical endpoint, and SES-CD or
    CDEIS as the instrument to assess the endoscopic endpoint. 
	 	●	While
    we will continue to use CDAI as entry criteria and primary endpoint given the availability of data, we will attempt to enroll
    patients with minimal requirements for SF and AP, as well as SES-CD criteria.

 

	 	○	Adapt
    design to MOA

	 	●	Slow
    onset (late primary endpoint). Use vedolizumab as reference, expecting more efficacy at later time points.
	 	●	To
    compensate for higher placebo effect of later endpoint, and given novel MOA not overlapping with others, choose previously-treated
    patient population for their lowest placebo effect (e.g., anti-TNF and anti-vedolizumab inadequate responders, IR)

	 	●	This
    will improve enrolment and reduce remission rates in placebo arm (~10% average [range: 4-16%] except in small studies, with
    ~30%)]

	 	●	Study
    MOA at the tissue level and study kinetics of effect (induction vs prevention of relapse)

 

	 	○	Play
    to the strengths of the program: 

	 	●	Innovative
    science
	 	●	Innovative
    endpoints with mRNA profiling and benchmarking against Janssen’s proprietary signatures
	 	●	Convenience
    for patients and sites:

	 	●	Oral
    
	 	●	Patient-
    and site- friendly streamlined design
	 	●	Try
    to leverage Janssen’s IBD dominance to offer incentives for participants (e.g., participation in extension with other
    Janssen assets).

 

	 	-	PATIENT
    POPULATION

 

	 	○	Moderate
    to severe Crohn’s Disease patients with objective inflammation and distal disease at baseline

	 	●	CDAI
    220-350 (also consider broader range of 220-450), and
	 	●	Elevated
    CRP OR fecal calprotectin (FCP) OR mucosal ulceration

	 	●	To
    be discussed: thresholds of CRP, FC that will maximize enrollment of patients with active endoscopic disease?
	 	●	To
    be discussed: require minimum mucosal involvement of one segment to avoid criticism of subjects with negative mucosal evidence
    yet meeting CDAI criteria? (i.e. require SES-CD score of >=3?)
	 	●	To
    be discussed: Possible requirement for stool frequency and abdominal pain: SF>=4 and AP >=2 (tentative inclusion unless
    significant impact on enrolment projections)

	 	○	Having
    failed one biologic agent (anti-TNF, vedolizumab, etc; just one MOA failure)

 

	 	-	DOSING
    REGIMEN

 

	 	○	TBC:
    150 mg BID vs placebo, oral formulation

[higher
dose than in RA, needed for receptor occupancy]

 

    	 	41	 

     

    

 

	 	○	Adaptive
    design: Automatic down-dosing to 100 mg BID if the safety lab elevations (ALT, CPK, WBC, etc) were significantly higher than
    expected

	 	●	Thresholds
    TBD

[narrow/inexistent
tox margins will trigger push back from HAs, but expecting to be able to overcome them with adaptive design and since risks are
known in humans and can be monitored]

 

	 	-
    	DURATION
    OF DOSING AND OVERALL STUDY

 

	 	○	12
    weeks of dosing and 12 weeks of follow-up

[12
weeks dosing as we can’t go any longer in dosing (only have 3 months tox at this time. This may change if Janssen conducts
additional tox studies, possibly enabling longer dosing and/or adding an open label study]

 

	 	●	Primary
    endpoint at week 12 (in principle; TBD if change to week 8)

[late
primary endpoint since slow MOA]

	 	●	Secondary
    and safety endpoints at week 12 and 24 

[add
secondary efficacy endpoints at 24 weeks to cover possible prevention of relapse signal]

 

	 	○	1-year
    target enrolment for target sample size of 80 (70-90) (see Sample Size below)

	 	●	Possibility
    to increase enrolment by up to a quarter without delaying delivery of data by end of 3rd year of project

 

	 	○	Unblinded
    Interim analysis by DSMB when 30-40% reach primary endpoint

	 	●	Ensure
    no worsening (safety and select efficacy endpoints)
	 	●	TBD:
    Futility analysis? (supporting RGNG design)

 

	 	○	Consider
    incentives for participation:

	 	●	Cross-over
    design?

	 	●	At
    least, offer placebo group 12 weeks of open label drug after study end

	 	●	Bridging
    study until Open Label enabled by toxicology?

	 	●	Offer
    new 12-week course of drug to objective responders with an objective relapse

	 	●	Enrolment
    into other Janssen study? 

	 	●	Study
    sequential therapy with another Janssen drug, eg. Simponi (anti-TNF, not approved for CD; this could be one way to get it
    approved), Stelara (anti-IL-12/23 p40) for induction followed by CSF1Ri for maintenance, other experimental meds

 

	 	-	SAMPLE
    SIZE

 

	 	○	Preliminary
    sample size: Ideal N approximately 80 (70-90), 3:2 randomization, 50 active and 30 placebo

	 	●	Preliminary
    minimum acceptable enrollment: 70 (40 active - 30 placebo) 
	 	●	Bayesian
    statistics to “borrow” placebo subjects (~15%) from previous studies

 

    	 	42	 

     

    

 

	 	○	Power
    (TBD)

	 	●	0.1
    alpha expected to yield acceptable power for a change in CDAI 
	 	●	if
    actual placebo rate is >20-25%, then CDAI portion of the study may be uninterpretable, and more objective endpoint will
    have to be analyzed (to be further defined in the SAP), for example:

	 	●	remission
    and >50% reduction in Calprotectin or CRP
	 	●	change
    in SES-CD
	 	●	Change
    in Histology score

 

	 	-	PRIMARY
    ENDPOINT

 

	 	○	Clinical
    effect at week 12, defined as change in CDAI as a continuous variable 

 

	 	-	SECONDARY
    AND EXPLORATORY ENDPOINTS

 

	 	○	Clinical
    endpoints

	 	●	Clinical
    response, defined by >=100-point decrease from baseline in CDAI 
	 	●	Clinical
    remission (CDAI <150)

 

	 	○	Endoscopy

	 	●	Response
    and remission as assessed by change in SES-CD score as continuous variable

	 	●	Preferred
    over CDEIS 
	 	●	Central
    read (e.g., Robarts or BioClinica)

	 	●	Proportion
    of patients with a 25% or 50% change from baseline in SES-CD

 

	 	○	PoM
    endpoints

	 	●	Circulating
    myeloid cells by flow cytometry

[Possibly
the fastest endpoint to change in the study]

	 	●	Mucosal
    Histology (biopsies at baseline and end of study): reduction in inflammatory myeloid cells (DC1, Macrophages)
	 	●	Mucosal
    mRNA signature: reduction in disease signature, compared to anti-TNF and other benchmarks available 

[This
is the most sensitive endpoint. We will use Janssen’s tissue mRNA data as benchmark and should see a change if the drug
works]

 

	 	○	PROs

	 	●	Novel
    Crohn’s endpoint based on SF and AP

 

	 	○	Biomarkers
    of inflammation

	 	●	Change
    in serum CRP: analysis of the subgroup with elevated CRP at baseline
	 	●	Stool
    calprotectin: reduction in FCP (stool also stored for potential future microbiome analysis), thresholds in fecal calprotectin
    such as those with FC < 250 or FC <500.

 

	 	-	OPERATIONAL
    CONSIDERATIONS (BASED ON RECENT EXPERIENCE)

 

	 	○	Countries

	 	●	Target
    70% Eastern Europe (Ukraine, Hungry, Poland, Russia) and 30% US/Canada (possible: select EU countries such as Germany, Spain)

	 	○	Enrollment
    estimates for 70-90 patients

	 	●	Eastern
    Europe, approximately 0.2-0.3 patients/site/month
	 	●	US/Canada
    approximately 0.1-0.2 patients/site/month

 

    	 	43	 

     

    

 

	 	○	Scree-Failure
    rate

	 	●	Assuming
    50%

	 	○	Number
    of active sites:

	 	●	40-50
    sites

	 	●	US/Canada:
    ~20 sites
	 	●	Ukraine:
    ~10 sites
	 	●	Poland:
    ~5 sites
	 	●	Hungary:
    ~5 sites
	 	●	Russia:~5
    sites

	 	○	Examples
    of CROs to be evaluated 

	 	●	PSI,
    Easthorn, Arensia for Eastern Europe
	 	●	Robarts
    vs Bioclinica for endoscopy

	 	○	Consider
    also at-home/in-pharmacy visits and remote data collection with the goal of improving ‘enrolability’ and reduce
    costs.

 

	 	-	COMPOUND
    REQUIREMENTS

 

	 	○	For
    the purposes of manufacturing and supply, we are planning supplies for 100 patients to be conservative in case circumstances
    changed or we had loss of a shipment (60 active, 40 placebo)
	 	○	Safest
    approach for API planning purposes is to have inventory for both the high and the low dose scenarios for up to 60 active patients.
    In other words, to plan for 60 at 150 mg, 60 at 100 mg and 40 on placebo. And because
    we additionally plan on offering the placebo group 12 weeks of open label drug (at 150 or 100 based on safety) in order to
    help with enrollment, the conservative approach is to have inventory for 100 patients at 150 mg BID, 100 patients at 100 mg
    BID (which we hope we won’t need to use) and 40 patients worth of placebo.
	 	 	 
	 	○	Maximum
    compound requirements would be:

 

20,160
150-mg Capsules Needed For High-Dose Scenario: 

 

	 	-	100 patients x 2 capsules per day x 84 days = 16,800
capsules

	 	-	In addition, we need 20% overage for inventory management
purposes across sites: + 3,360 capsules

	 	-	Total: 20,160 capsules

 

38,640
50-mg Capsules Needed For Low-Dose Scenario: 

 

	 	-	100 patients x 4 capsules per day x 84 days =
33,600 capsules [1,680 g]

	 	-	Since we start with the high-dose, we may not need as
much overage as the low-dosse arm would likely enroll less than 60 patients, so let’s say 15% overage, or 5,040 capsules

	 	-	Total: 38,640 capsules

 

16,128
Matching Placebo Capsules:

 

	 	-	40 patients x 4 capsules per day (it would be 2/day
for high-dose and 4/day for low dose) x 84 days = 13,440

	 	-	Then 20% overage = 2,688

	 	-	Total = 16,128 capsules

 

 

 

    	 	44	 

     

     

Schedule
3: Janssen Patents Rights

  

[****] 

 

    	 	45	 

     

     

Schedule
4: Joint Patents Rights

 

NONE

 

    	 	46

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