Document:

Exhibit 10.10

 

EXECUTION COPY

 

LICENSE AGREEMENT

 

This License Agreement
(this “Agreement”), dated as of March 29, 2011 (the “Effective Date”), is made by and between DAINIPPON
SUMITOMO PHARMA CO. LTD., a company organized under the laws of Japan (“DSP”), having a place of business at 6-8 Doshomachi
2-chome, Chuo-ku, Osaka 541-0045 Japan, and INTERCEPT PHARMACEUTICALS, INC., a company organized under the laws of the State of
Delaware (“Intercept”), having a place of business at 18 Desbrosses Street, New York, New York 10013. DSP and Intercept
are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

 

RECITALS

 

Whereas,
Intercept is a clinical stage biopharmaceutical company engaged in the development of therapeutics for the treatment of metabolic
diseases, and is currently developing Obeticoholic acid, a farnesoid X receptor (FXR) agonist,
more commonly known as 6α-ethyl-3α,7α-dihydroxy-5β-cholan-24-oic acid (6-ECDCA) or INT-747, in any form
(the “Compound”) to be used to formulate a new product
for therapeutic use in connection with primary biliary cirrhosis (“PBC”) and nonalcoholic steatohepatitis (“NASH”)
(PBC and NASH, collectively the “Field”);

 

Whereas,
Intercept is simultaneously engaged in the development of other indications for the Compound, including in connection with portal
hypertension (together with all present and future indications of the Compound, each an “Additional Indication”, and
collectively, the “Additional Indications”);

 

Whereas,
DSP is a worldwide pharmaceutical company that has significant experience in the development, manufacturing and commercialization
of pharmaceutical products in the Territory (as defined hereinafter); and

 

Whereas,
Intercept desires to grant certain exclusive rights to DSP in the Territory with respect to the development, manufacturing and
commercialization of the Compound and the Product in the Field
in the Territory and DSP wishes to accept the grant of such rights; all as more particularly set forth in this Agreement.

 

Now
Therefore, in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in
this Agreement, the Parties agree as follows:

 

1.          DEFINITIONS

 

Whenever used in the
Agreement with an initial capital letter, the terms defined in this Article 1 shall have the meanings specified below.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 

    	 

    

 

“Actual
Costs” shall mean Intercept’s direct costs and indirect costs incurred by sub-contractors of Intercept of materials
and labor specifically incurred in Manufacturing or formulating the Clinical Supplies or Commercial Supplies supplied to DSP under
the Clinical Supply Agreement or the Commercial Supply Agreement, including but not limited to excipients and packaging components
for both the Compound and the Product, as well as inprocess and release testing, stability testing, development of the Specifications,
manufacturing validation, quality assurance and quality control activities necessary to release the Compound or Product to DSP
or to a Third Party designated by DSP; together with directly allocable manufacturing overheads specifically attributable to the
Manufacture or formulation of the Compound or Product under this Agreement, including depreciation and maintenance costs of fixed
assets that are wholly dedicated to and used in manufacturing the Compound or Product for DSP; but excluding corporate, general
or administrative overheads. Actual Costs shall be calculated in accordance with Intercept’s standard cost accounting policies
and with generally accepted accounting principles, consistently applied to the manufacture of pharmaceutical compounds and products.

 

“Additional
Indications” shall have the meaning set forth in the second recital of this Agreement.

 

“Additional
Indications Option” shall have the meaning set forth in Section 7.2.

 

“Additional
Indications Option Commencement Notice” shall have the meaning set forth in Section 7.3.

 

“Additional
Indications Exercise Period” shall have the meaning set forth in Section 7.3.

 

“Additional
Indications Option Fee” shall have the meaning set forth in Section 7.3.

 

“Affiliate”
shall mean any corporation, firm, limited liability company, partnership or other entity that directly controls or is controlled
by or is under common control with a Party to this Agreement. For purposes of this definition only, “control” and,
with correlative meanings, the terms “controlled by” and “under common control with” shall mean the possession,
directly or indirectly through one or more intermediaries, of the power to direct the management or policies of an entity, whether
through the ownership of fifty percent (50%) or more of the voting securities of the other organization or entity or by contract
relating to voting rights or corporate governance. Notwithstanding the foregoing, Sumitomo Chemical Co., Ltd. (“Sumitomo
Chemical”), the parent company of DSP, shall not be considered an Affiliate for the purposes of this Agreement; provided
that DSP shall be permitted to engage in routine reporting of matters concerning this Agreement to Sumitomo Chemical.

 

“Clinical
Supply Agreement” shall have the meaning set forth in Section 6.1.

 

“Clinical
Supplies” shall mean Compound formulated into Product or matching placebos to be used exclusively for conducting
clinical studies to gain Regulatory Approval in the Territory.

 

“CMC”
shall mean the Chemistry, Manufacturing and Controls information required to be submitted under Section 505 of the
U.S. Food, Drug and Cosmetic Act (as amended) and 21 C.F.R. 312.23(a)(7)
and 314.50(d)(1).

  

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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“Commercial
Supplies” shall mean the supply of the Product in bulk formulation (either packaged or pre-packaged) made to DSP
by Intercept pursuant to Section 6.2 of this Agreement and the Commercial Supply Agreement.

 

“Commercial
Supply Agreement” shall have the meaning set forth in Section 6.2.

 

“Commercialize”
shall mean to promote, market, distribute, sell (and offer for sale or contract to sell) or provide product support for a Product,
including by way of example: (i) detailing and other promotional activities in support of a Product; (ii) advertising and public
relations in support of a Product, including market research, development and distribution of selling, advertising and promotional
materials, field literature, direct-to-consumer advertising campaigns, media/journal advertising, and exhibiting at seminars and
conventions; and (iii) developing reimbursement programs and information and data specifically intended for managed care organizations,
governmental agencies and the like.

 

“Commercially
Reasonable Efforts” shall mean with respect to a Party’s obligations under this Agreement, including to Develop,
Manufacture or Commercialize the Product, those efforts and resources consistent with the usual practices of such Party in pursuing
the development or commercialization of its own pharmaceutical products that are of similar market potential and strategic value
as such Product, taking into account all relevant factors including product labeling or anticipated labeling, present and future
market potential, past performance of such product and such Party’s other pharmaceutical products that are of similar market
potential, financial return, medical and clinical considerations, past and future regulatory environment and competitive market
conditions, all measured by the facts and circumstances at the time such efforts are due. Commercially Reasonable Efforts shall
be determined on a country-by-country and indication-by-indication basis for the Product, and it is anticipated that the level
of effort will change over time, reflecting changes in the status of the Products and the market(s) or countries involved.

 

“Confidential Information”
shall mean with respect to a Party (the “Receiving Party”), all information which is disclosed by the other Party (the
“Disclosing Party”) to the Receiving Party hereunder or to any of its employees, consultants, Affiliates, licensees
or sublicensees, which is marked as confidential or indicated at the time of disclosure as being confidential (and subsequently
summarized in writing) except to the extent that the Receiving Party can demonstrate by written record that such information, (i)
as of the date of disclosure is demonstrably known to the Receiving Party or its Affiliates other than by virtue of a prior confidential
disclosure to such Party or its Affiliates; (ii) as of the date of disclosure is in, or subsequently enters, the public domain,
through no fault or omission of the Receiving Party; (iii) is obtained from a Third Party having a lawful right to make such disclosure
free from any obligation of confidentiality to the Disclosing Party; or (iv) is independently developed by or for the Receiving
Party without reference to or reliance upon any Confidential Information of the Disclosing Party; or (v) is required to be disclosed
by judicial or governmental authority of competent jurisdiction; provided that the Receiving Party shall first provide the Disclosing
Party with sufficiently timely notice of such requirement to permit the Disclosing Party to take measures to avoid or limit the
scope of the requested disclosure. Confidential Information shall include, without limitation, results and data of any type whatsoever,
in any tangible or intangible form whatsoever, including, preclinical data, clinical trial data, databases, practices, methods,
techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological,
biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies
and procedures.

  

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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“Compound”
shall have the meaning set forth in the first recital of this Agreement.

 

“Control”
or “Controlled” shall mean, when used in reference to intellectual property, other intangible property,
or materials, that a Party owns or has a license or sublicense to such intellectual property, other intangible property or materials,
and has the ability to grant a license or sublicense or other right to use such intellectual property, other intangible property
or materials, as applicable, as provided for herein, without violating the terms of any agreement or other arrangement with any
Third Party; provided that where the ability to grant a license or sublicense is subject to a Third Party consent or notice requirement,
“Commercially Reasonable Efforts” shall require seeking such consent or providing such notice to the Third Party.

 

“Country
Option” shall have the meaning set forth in Section 8.1.

 

“Country
Option Exercise Notice” shall have the meaning set forth in Section 8.2.

 

“Development”
and “Develop” shall mean with respect to the Compound or the Product, all activities relating to preparing
and conducting non-clinical studies, clinical studies (Phase I Clinical Trials, Phase II Clinical Trials, Phase III Clinical Trials
and Phase IV Clinical Trials), formulation, development, statistical analysis, quality assurance and quality control activities
and other product development activities, which may include, but is not limited to, research, and regulatory activities directed
toward obtaining Regulatory Approval of the Product in the Field inside or outside the Territory, as the case may be.

 

“DSP Defense
Costs” shall have the meaning set forth in Section 12.3.

 

“Effective
Date” shall have the meaning set forth in the first line of this Agreement.

 

“Eroded
Country” shall have the meaning set forth in Section 9.3.1.

 

“Exclusive
Period” shall mean, on a country-by-country basis, the period beginning upon the First Commercial Sale of the Product
in the relevant country until the later to occur of (i) the expiration of (x) the Intercept substance patent with respect to Japan
or (y) the last to expire of the Intercept patent family members with respect to China, after giving effect, in each of items (x)
and (y) to any Patent Term Extensions, and (ii) the date upon which generic drugs relying on the Compound or Product data for Regulatory
Approval may be introduced.

 

“Field”
shall have the meaning set forth in the first recital of this Agreement, together with any other Additional Indications, which
shall each automatically be included in the “Field” upon the exercise by DSP of the Additional Indication Option.

  

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
4

    	 

    

 

“First
Commercial Sale” shall mean, on a country-by-country basis, the date of the first arm’s length transaction,
transfer or disposition for value to a Third Party of a Product by or on behalf of DSP or any Affiliate or sublicensee of DSP in
such country after receipt of Marketing Approval, (and any labeling or pricing negotiationsthat
may be required after Marketing Approval for such Product in the Territory.) 
A First Commercial Sale shall not include any Product sold for use in clinical trials, for research or for other non-commercial
uses, or that is supplied as part of a compassionate use or similar program.

 

“First
Tier Royalty Rate” shall have the meaning set forth in Section 9.2.3.

 

“GMP”
shall mean all applicable Good Manufacturing Practices standards, including, as applicable, those standards required by the
MHLW or its equivalent in each country in the Territory.

 

“Good Clinical
Practices” or “GCP” shall mean all applicable Good Clinical Practice standards for the
design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable,
(i) those standards required by the MHLW or its equivalent in the Territory, and (ii) the equivalent Laws in any relevant country,
each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that
the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial
subjects.

 

“Good Laboratory
Practices” or “GLP” shall mean all applicable Good Laboratory Practice standards, including, as
applicable, (i) those standards required by the MHLW as hereinafter defined or its equivalent in each country in the Territory,
and (ii) the equivalent Laws in any relevant country, each as may be amended and applicable from time to time.

 

“Improvement”
shall mean any improvements, enhancements or modifications to the Intercept Technology, the Intercept Manufacturing Technology,
or other technology claimed in the Intercept Patents (whether patentable or not), which would be useful or necessary in the Manufacture,
Development, and Commercialization of the Compound and/or Products,
which is conceived, solely by one Party or jointly by one Party with a Third Party or jointly by both Parties.

 

“IND”
shall mean the equivalent application of an Investigational New Drug Application to the MHLW or its equivalent in any country in
the Territory, such as a clinical trial application or a clinical trial exemption, the filing of which is necessary to commence
or conduct clinical testing of a pharmaceutical product in humans in such country.

 

“Intercept
Change of Control” shall mean: (i) the liquidation or dissolution of Intercept or the sale or other transfer by Intercept
of all or substantially all of its respective assets; or (ii) the occurrence of a tender offer, stock purchase, other stock acquisition,
merger, consolidation, recapitalization, reverse split, sale or transfer of assets or other transaction, as a result of which any
person or entity (x) becomes the beneficial owner, directly or indirectly (including through multiple entities), of respective
securities of Intercept representing more than fifty percent (50%) of the combined voting power with respect to the election of
directors of Intercept, (y) obtains the ability to appoint a majority of the Board of Directors of Intercept, or (z) obtains the
ability to direct the operations or management of Intercept or any successor to the business of Intercept.

  

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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“Intercept
Development Plan” shall have the meaning set forth in Section 3.1.2.

 

“Intercept
Know-How” shall mean the Know-How which Intercept or its Affiliates Control on the Effective Date or during the Term,
which information is necessary or useful for the Development, Manufacture or Commercialization of the Product or the Compound in
the Field in the Territory.

 

“Intercept
Manufacturing Know-How” shall mean all methods, processes, designs, patterns, or know-how, programs, systems, procedures,
technical data, technology, information, data, results of tests, studies, and analyses, whether patentable or not, which are specifically
related to the manufacturing process of the Compound and/or the Product, including Know-How that is in the case of each of the
foregoing Controlled by Intercept (or its Affiliates) as of the Effective Date or during the Term of this Agreement.

 

“Intercept
Manufacturing Patent” shall mean any Patent that is Controlled by Intercept (or its Affiliates) as of the Effective
Date and/or during the Term, in each case, which is necessary or useful for the Manufacture of the Compound or the Product for
Commercialization in the Field in the Territory.

 

“Intercept
Manufacturing Technology” shall mean the Intercept Manufacturing Know-How and the Intercept Manufacturing Patents.

 

“Intercept
Patents” shall mean all Patents that Intercept Controls as of the Effective Date or during the Term, which Patents
are necessary or useful for the purpose of Development, Manufacture or Commercialization of the Compound or the Product in the
Field in the Territory, all as more particularly set forth on Exhibit A.

 

“Intercept
Technology” shall mean the Intercept Patents
and the Intercept Know-How.

 

“Joint
Steering Committee” or “JSC” shall mean the joint steering committee formed by the Parties as
described in Section 3.1.

 

“Joint
Improvements” shall mean an Improvement or invention, whether patentable or not, which is invented, made or
discovered jointly by or on behalf of the employee(s), licensee(s) (including sublicensees), or contractors (including subcontractors)
of both Parties (and/or their Affiliates).

 

“Know-How”
shall mean intellectual property including any asset that comprises any of the following items and has a substantial
value independent of the services of any individual: inventions, formulae, processes, designs, patterns, or know-how; copyrights;
trademarks, trade names, or brand names; franchises; methods, programs, systems, procedures, campaigns, surveys, studies, forecasts,
estimates, customer lists, or technical data; and other similar items (whether or not in documentary form and whether or not patentable,
copyrightable or otherwise protectable under applicable Laws).

  

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
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“Laws”
shall mean all applicable laws, statutes, rules, regulations, directives, decisions, ordinances, guidelines concerning
the Development, Manufacturing and Commercialization of the Compound or the Product in the Field in the Territory.

 

“Manufacturing”
shall mean all activities related to the production, manufacture, testing, processing, filling, finishing, packaging, labeling,
inspection, receiving, holding and shipping of the Compound and/or the Product, the Clinical Supplies or the Commercial Supplies,
or any raw materials or packaging materials with respect thereto, or any intermediate of any of the foregoing, including process
and cost optimization, process qualification and validation, commercial manufacture, stability and release testing, quality assurance
and quality control. For clarity, “Manufacture” has a correlative meaning.

 

“Marketing
Approval” shall mean (i) for the United States, the approval of an NDA, and (ii) for jurisdictions in the Territory,
the approval from the relevant Regulatory Authority necessary to market and sell the Product in that country, including, where
required, pricing approvals.

 

“Market
Share” shall have the meaning set forth in Section 9.3.1.

 

“MHLW”
shall mean the Japanese Ministry of Health, Labor and Welfare, or a successor agency thereto.

 

“NASH”
shall have the meaning set forth in the first recital of this Agreement.

 

“Necessary
Third Party Patents” shall mean, on a country-by-country and indication-by-indication basis, the patents that are
owned or controlled by a Third Party, which do not infringe the Intercept Technology, but are necessary for the Development, Manufacturing
or Commercialization of the Compound or the Product in the Field, as reasonably determined in accordance with Section 4.3.

  

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
7

    	 

    

 

“Net Sales”
shall mean the gross amounts invoiced by DSP and its Affiliates and sublicensees for sales or other dispositions of the Product
to Third Parties that are not Affiliates or sublicensees in the Field in the Territory, in bona fide, arms-length transactions
less the following items, as allocable to such Products (if not previously deducted from the amount invoiced): (i) trade, cash
or quantity discounts, credits or allowances actually allowed (provided that such discounts are applied in a normal and customary
manner with respect to other similarly situated products of the selling party, and not in a manner which is unreasonably disproportionate
to one or more Products when compared to other products of the selling party); (ii) charge back payments, administrative fees,
price reductions, rebates allowed or granted, or other forms of consideration to managed care organizations, government agencies
or trade customers, including wholesalers and chain and pharmacy buying groups (provided that such discounts are applied in a normal
and customary manner with respect to other similarly situated products of the selling party, and not in a manner which is unreasonably
disproportionate to one or more Products when compared to other products of the selling party); (iii) credits actually allowed
for claims, allowances for damaged goods, retroactive price reductions or returned goods; (iv) prepaid freight, postage, shipping,
customs duties and insurance charges; and (v) sales taxes, value added taxes, duties and other governmental charges. Such amounts
shall be determined in accordance with Japanese GAAP, consistently applied, or GAAP in effect in a country in the Territory, as
permitted by DSP. Any of the items set forth above that would otherwise be deducted from the invoice price in the calculation of
Net Sales but which are separately charged to Third Parties shall not be deducted from the invoice price in the calculation of
Net Sales. Further, in the case of any sale or other disposal other than in an arm’s length transaction exclusively for cash,
such as barter or counter-trade, of any Product, or part thereof, Net Sales shall be determined by referencing Net Sales at which
substantially similar quantities of the Product are sold in an arm’s length transaction for cash. Finally, financial compensation,
if any, received by DSP from a subsequent resale of the Product by a third party reseller, if any, shall be included in the calculation
of Net Sales.

 

“NDA”
shall mean a new drug application or its equivalent filed with a Regulatory Authority in the Territory seeking Regulatory Approval
to Commercialize the Product in the Territory for a particular indication within the Field.

 

“Non-Territory
Data” shall have the meaning set forth in Section 4.2.2.

 

“Patents”
means any patents and patent applications and all substitutions, divisions, continuations, continuations-in-part, any patent issued
with respect to any such patent applications, any reissue, reexamination, utility models or designs, renewal, adjustment or extension
(including any supplementary protection certificate) of any such patent, and any confirmation patent or registration patent or
patent of addition based on any such patent, and all counterparts thereof in any country owned or Controlled by a Party on the
Effective Date and during the Term of this Agreement.

 

“Patent
Term Extension” means any term extensions, adjustments, supplementary protection certificates, regulatory exclusivity
and equivalents thereof offering Patent protection beyond the initial term with respect to any issued Patents.

 

“PBC”
shall have the meaning set forth in the first recital of this Agreement.

 

“Phase
I Clinical Trial” means a clinical trial in humans, the principal purpose of which is to make a preliminary determination
of metabolism, pharmacokinetics, dose findings or preliminary safety in healthy individuals or patients in the Territory.

 

“Phase
II Clinical Trial” means a clinical trial in humans, the principal purpose of which is to make a preliminary determination
that a given product is safe in the population in the Territory for its intended use and to obtain information about such product’s
efficacy sufficient to permit the design of further clinical trials, or if no further trials are necessary, to enable an Regulatory
Approval.

  

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
8

    	 

    

 

“Phase
III Clinical Trials” shall mean a clinical trial of a Product conducted in human patients with a defined dose or
a set of defined doses of a Product designed to ascertain efficacy and safety of such Product for the purpose of submitting applications
for Regulatory Approval to the competent Regulatory Authorities.

 

“Phase
IV Clinical Trials” means post-marketing studies to delineate additional information about a pharmaceutical product’s
risks and benefits, and optimal use, commenced after receipt of Regulatory Approval for a Product in the indication for which such
trial was conducted.         

 

“Product”
shall mean any pharmaceutical composition or formulation that contains the Compound, whether or not such Product is used as a single
agent or in combination with other therapeutically active components, as the term “Product” may be further defined
in each of the Clinical Supply Agreement and the Commercial Supply Agreement.

 

“Product
Development Plan” shall have the meaning set forth in Section 3.1.1.

 

“Quality
Assurance Agreement” shall have the meaning set forth in Section 6.3.5.

 

“Regulatory
Approval” shall mean all necessary approvals (including INDs, NDAs, product approvals, import permits, and, in each
case any supplements and amendments thereto), licenses, registrations or authorizations of any Regulatory Authority, necessary
for the Development, Manufacture, and Commercialization of the Compound or the Product in the Field in the Territory.

 

“Regulatory
Authority” shall mean, in a particular country in the Territory, any applicable governmental authority involved in
granting Regulatory Approval in the Territory, including the MHLW.

 

“Second
Tier Royalty Rate” shall have the meaning set forth in Section 9.2.3.

 

“Specifications”
shall mean those tests, methods and acceptance criteria for the Compound and the Product required in the Territory as set forth
the in the IND and NDA.

 

“Target
Actual Cost” shall have the meaning set forth in Section 6.2.2.

 

“Target
Country” shall have the meaning set forth in Section 8.3.

 

“Technical
Transfer” shall have the meaning set forth in Section 6.4.1.

 

“Technology”
shall mean and include any and all unpatented, proprietary ideas, inventions, discoveries, Confidential Information, biologic materials,
data, results, formulae, designs, specifications, methods, processes, formulations, techniques, ideas, know-how, technical information
(including, without limitation, structural and functional information), process information, pre-clinical information, clinical
information, regulatory filings, and any and all proprietary biological, chemical, pharmacological, toxicological, pre-clinical,
clinical, assay, control and manufacturing data and materials.

 

“Term”
shall have the meaning set forth in Section 15.1.

  

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
9

    	 

    

 

“Territory”
shall mean Japan and China (excluding Taiwan), and such other countries which are the subject of the Country Option, each of which
shall be automatically deemed included in the Territory upon the exercise of the Country Option by DSP for such country.

 

“Third
Party” shall mean any person or entity other than DSP or Intercept, and their respective Affiliates.

 

“Third
Tier Royalty Rate” shall have the meaning set forth in Section 9.2.3.

 

“Third
Party Offer Notice” shall have the meaning set forth in Section 9.3.

 

“Wholesale
Acquisition Cost” or “WAC” shall mean the wholesaler acquisition cost for the Product in
the U.S.

 

2.          GRANT
OF RIGHTS

 

2.1           Exclusive
License

 

2.1.1           Grant
of Exclusive License. Intercept hereby grants to DSP an exclusive, royalty-bearing license, including the right to grant
sublicenses in accordance with Section 2.1.2, under the Intercept Technology to research, Develop, have Developed, make, have made,
use, sell, offer for sale, have sold, import, have imported, export and have exported, register, for the purpose of Commercializing
the Product in the Territory, for any and all uses within the Field, subject to the terms and conditions of this Agreement. For
clarification, the Parties agree that DSP’s appointing a sublicensee to engage in the Manufacture of the Compound or the
Product outside the Territory for the Development and Commercialization of the Product inside the Territory shall not be deemed
a breach of this Agreement.

 

2.1.2           Right
to Sublicense. After Intercept’s receipt of the Upfront Fee set forth in Section 9.1, DSP shall have the right to
grant sublicenses to any Affiliate or Third Party to all or any portion of its rights under the license granted to DSP pursuant
to this Section 2; provided, however, that (i) Intercept shall be notified of and approve the sublicensing arrangement, such approval
not to be unreasonably withheld, (ii) each such sublicensee agrees to be bound by all applicable Sections of this Agreement, and
(iii) DSP shall provide Intercept with a summary of such sublicensing agreements, to include (a) the country in the Territory applicable
to such sublicensee, (b) the full legal name of the sublicensee, (c) the applicable indications in the Field, (d) the term and
termination provisions of the sublicensing agreement, and (e) the standard of performance applicable to the sublicensee with respect
to its obligations under the sub-licensing agreement. Items (a)-(e) inclusive of item (iii) of the preceding sentence shall be
set forth in a format substantially similar to Exhibit B, which shall also be executed by the relevant sublicensee affirming
its understanding of and willingness to comply with Sections of this Agreement applicable to it.

 

2.1.3           Patent
Challenge. Any challenge to the validity, scope or enforceability of any claim in an Intercept Patent by DSP or its Affiliates
shall constitute a material breach of this Agreement.

  

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
10

    	 

    

 

2.2           Registration.
Upon DSP’s request, but only after Intercept’s receipt of the Upfront Fee set forth in Section 9.1, Intercept shall
use Commercially Reasonable Efforts, at DSP’s sole expense, to register a “Senyo-Jisshiken Tohroku”
(i.e. registration of the exclusive license with the Japanese Patent Office) for DSP (or the equivalent in any other country in
the Territory) with respect to the Intercept Technology and Intercept Patents, which registration shall be transferred or assigned
to DSP by Intercept immediately upon issuance for no additional consideration.

 

2.3           No
Implied Licenses; Retained Rights. Except as explicitly set forth in this Agreement, neither Party grants any license,
express or implied, under its intellectual property rights to the other Party, whether by implication, estoppel or otherwise

 

2.4           Bankruptcy-Related
Rights.

 

2.4.1           U.S.
Bankruptcy Code 365(n). All rights and licenses granted under this Agreement are hereby deemed to be, for purposes of Section
365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101(35A)
of the U.S. Bankruptcy Code. The Parties shall retain and may fully exercise all of their respective rights and elections under
the U.S. Bankruptcy Code. The Parties agree that DSP, as the licensee under this Agreement, shall retain and may fully exercise
all of its rights and elections under the U.S. Bankruptcy Code, and that upon commencement of a bankruptcy proceeding by or against
Intercept under the U.S. Bankruptcy Code, DSP shall be entitled to a complete duplicate of or complete access to any such intellectual
property and all embodiments of such intellectual property, provided that DSP continues to fulfill its payment or royalty obligations
in accordance with this Agreement. Such intellectual property and all embodiments thereof shall be promptly delivered to DSP (x)
upon any such commencement of a bankruptcy proceeding upon written request therefore by DSP, unless Intercept elects to continue
to perform all of its obligations under this Agreement or (y) if not delivered under (x) above, upon the rejection of this Agreement
by or on behalf of Intercept upon written request therefor by DSP. The foregoing is without prejudice to any rights DSP may have
against Intercept arising under the U.S. Bankruptcy Code or other applicable law.

 

2.4.2           Intellectual
Embodiments. Each Party hereby acknowledges that (i) copies of research data (both clinical and non-clinical), (ii) laboratory
samples, (iii) product samples and inventory, (iv) formulae, (v) laboratory notes and notebooks, (vi) data and results related
to clinical and non-clinical trials, (vii) regulatory filings and approvals, (viii) rights of reference in respect of regulatory
filings and approvals, (ix) pre-clinical research data and results, and (x) marketing, advertising and promotional materials, constitute
“embodiments” of intellectual property pursuant to Section 365(n) of the Bankruptcy Code.

 

2.5           Bankruptcy
Assistance. Each Party agrees not to interfere with the other Party’s exercise of rights and licenses to intellectual
property licenses granted to the Party pursuant to Section 2.4
or under Section 365(n) of the U.S. Bankruptcy Code and embodiments
thereof in accordance with this Agreement and agrees to use Commercially Reasonable Efforts to assist the other Party to obtain
such intellectual property and embodiments thereof in the possession or control of Third Parties, as reasonably necessary for the
other Party to exercise such rights and licenses in accordance with this Agreement. 

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
11

    	 

    

 

3.          GOVERNANCE

 

3.1           Joint
Steering Committee. The Parties shall use Commercially Reasonable Efforts to establish the JSC within sixty (60) days after
the Effective Date. The JSC shall engage in consultation, discussion and decision-making with respect to the following:

 

3.1.1           A
development plan for the Development of the Product in the Territory (the “Product Development Plan”) and any material
amendments thereto;

 

3.1.2           A
development plan for the Development of the Product and the Additional Indications by Intercept and/or its licensees outside the
Territory (the “Intercept Development Plan”), and any
material amendments thereto;

 

3.1.3           Clinical
trials to be conducted in connection with the Development of the Compound and the Product in the Field in the Territory; including,
as appropriate Phase I Clinical Trials, Phase II Clinical Trials, Phase III Clinical Trials and Phase IV Clinical Trials,
including review of synopses of clinical study protocols;

 

3.1.4           Nonclinical
studies, including CMC and formulations, to be conducted in connection with the Development of the Compound and the Product in
the Field in the Territory;

 

3.1.5           Development
of Additional Indications to be conducted outside the Territory by Intercept and/or its licensees in connection with the Additional
Indications Option;

 

3.1.6           Matters
related to Regulatory Approvals for Product in the Field in the Territory, including the formulation of a plan consistent with
this Agreement for the exchange of and reporting to Regulatory Authorities of safety data reported or arising in the course of
the Development;

 

3.1.7           The
activities of any sub-committees;

 

3.1.8           Encouraging
and facilitating communication between the Parties regarding the progress and results (whether preliminary or final) of the Development
and Manufacturing activities for the Compound and the Product in the Field in the Territory, including the coordination of clinical
and nonclinical data exchange and preparation of regulatory filings;

 

3.1.9           The
filing, maintenance, and abandonment, if any, of the Intercept Patents (including the Intercept Manufacturing Patents) and any
patents issued on Improvements or Joint Improvements, and all Patent Term Extensions;

 

3.1.10         Matters
relating to the Manufacture of the Clinical Supplies and the Commercial Supplies, including the details and timing of the Technical
Transfer; 

  

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
12

    	 

    

 

3.1.11         Establish
internal rules for the governance and operation of the JSC; and

 

3.1.12         Such
other responsibilities as may be assigned to the JSC pursuant to this Agreement or as may be mutually agreed upon by the Parties
in writing from time to time.

 

3.2           JSC
Membership. The initial membership of the JSC shall be comprised of three (3) representatives designated by each of DSP
and Intercept, at least one (1) of whom from each Party shall be
senior enough within its respective organization to have the requisite decision-making authority with respect to the matters set
forth in Section 3.1 above, and all of whom shall have appropriate expertise and ongoing familiarity with the Development and Manufacturing
of the Product in the Field in the Territory. From time to time, the number and qualifications of the designated members to the
JSC may be changed by the mutual written agreement of the Parties, so long as an equal number of members from each of DSP and Intercept
is maintained. Each Party shall inform the other Party of its initial representatives to the JSC as soon as practicable after the
Effective Date. Each Party may also designate non-voting representatives to attend the meetings from time to time as necessity
requires, but only with the consent of the other Party. The JSC shall be chaired by a representative from DSP, who shall be responsible
for (i) calling meetings, (ii) preparing and issuing minutes of each such meeting as soon as practicable following each meeting,
and (iii) preparing and circulating an agenda for the upcoming meeting, which shall include agenda items proposed by either Party
no less than ten (10) calendar days prior to the next scheduled JSC meeting.

 

3.3           JSC
Meetings. The JSC shall hold meetings at least once every six months, and more frequently as necessity requires. The first
JSC meeting shall be held at a mutually agreed venue and date following the Effective Date. Meetings of the JSC shall be effective
only if at least one (1) representative of each Party is present or participating. The JSC may meet either (i) in person at either
Party’s facilities, or (ii) by audio or video teleconference. Additional meetings of the JSC may also be held with the consent
of each Party. Each Party shall be responsible for all of its own expenses incurred in connection with participating in the JSC
meetings or any of the other committee meetings.

 

3.4           Decision-Making.
The JSC shall endeavor to reach consensus on all matters brought before it pursuant to Section 3.1, with each Party having a single
vote, irrespective of the number of representatives actually in attendance at a meeting. The JSC shall use Commercially Reasonable
Efforts to resolve the matters brought before it pursuant to Section 3.1. DSP shall have the final decision making authority with
respect to Development of the Compound and Product in the Field in the Territory. In the event that either Party has concern about
whether the Development and the Commercialization of the Compound and/or the Product is reasonably likely to have a materially
negative impact on the Compound or the Product inside or outside the Territory, the Parties shall consult through the JSC for a
period of thirty (30) days; failing resolution of which, such matter shall be elevated to the CEO of Intercept and the CEO of DSP,
for attempted resolution in good faith within the time frame set forth in Section 16.1.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
13

    	 

    

 

3.5           Progress
Reports and Exhibit Amendments. At each meeting of the
JSC and, as applicable, that of any sub-committee or new committee established by the JSC, DSP shall provide Intercept with a written
report summarizing its activities and progress regarding the Development and Commercialization of the Compound and Product in the
Field in the Territory, including its marketing and promotional materials, which may, in DSP’s option, be in the local language
of the country in the Territory to which it pertains. At each meeting of the JSC, and, as applicable, that of any sub-committee
or new committee established by the JSC, Intercept shall provide DSP with a written report summarizing its Development activities
of the Compound and Product outside the Territory and its Development
activities of the Additional Indications outside the Territory. In addition, at each meeting of the JSC, each Party shall inform
the other of any Improvements conceived by or on behalf of such Party, as well as any Joint Improvements.
Notwithstanding Section 17.4, upon the notification to the JSC through a progress report (or otherwise) of the filing of
a patent application with respect to any Improvement or Joint Improvement, Exhibit A shall be deemed automatically amended,
and an updated version of Exhibit A shall be distributed to the Parties together with the meeting minutes.

 

3.6           Sub-committees.
From time to time, the JSC may establish and delegate duties to sub-committees to oversee particular projects or activities.
Each such sub-committee shall be constituted and shall operate as the JSC determines. Each sub-committee and its activities shall
be subject to the oversight, review and approval of, and shall report to, the JSC. It is contemplated that, at the appropriate
time, the JSC will expand its scope of activity to include consultation, discussion and decision-making with respect to Commercialization
or, alternatively, decide that a separate decision-making committee should be established to govern Commercialization planning
and implementation. In the case that the JSC decides that such a new committee should be established, such committee shall be formed
and governed according to the same principles as the JSC.

 

3.7           Alliance
Manager. Each Party shall designate an alliance manager, who shall be responsible for the day-to-day coordination of the
collaboration between the Parties and shall facilitate communication between the Parties. The Alliance Manager, may but need not
be, one of the designated members of the JSC.

 

4.          DEVELOPMENT
AND COMMERCIALIZATION 

 

4.1           Commercially
Reasonable Efforts.

 

4.1.1           DSP’s
Commercially Reasonable Efforts. From and after the
Effective Date, DSP shall use Commercially Reasonable Efforts to Develop and Commercialize the Compound and the Product in the
Field (including with respect to any Additional Indications) in the Territory. Subject to Section 9.4, DSP shall be responsible
for all costs and expenses incurred by it in connection with such Development and Commercialization activities.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
14

    	 

    

 

4.1.2           Intercept’s
Commercially Reasonable Efforts. From and after the Effective Date, Intercept shall use Commercially Reasonable Efforts
to Develop the Compound and the Product anywhere outside the Territory, either on its own or through Third Party licensees or subcontractors.
In addition, from and after the Effective Date, Intercept shall (i) use Commercially Reasonable Efforts to Develop the Additional
Indications outside the Territory in accordance with the Intercept Development Plan outside the Territory and (ii) shall use Commercially
Reasonable Efforts to cause each of its licensees to use Commercially Reasonable Efforts to Develop the Additional Indications
outside the Territory.

 

4.2           Information
and Data Exchange.

 

4.2.1           Intercept
Technology. No later than thirty (30) days following Intercept’s receipt of the Upfront Fee set forth in Section
9.1, Intercept shall transfer and otherwise make available to DSP, its Affiliates and its designated Third Party subcontractors
the Intercept Technology and all material information and data relating thereto to enable DSP to engage in the Development and
Commercialization of the Product in the Field in the Territory. The transfer of the Intercept Technology and related information
and data shall be made in readily accessible electronic format wherever possible. Following the payment of the “Upfront Payment”
pursuant to Section 9.1, Intercept shall, for no additional consideration, undertake to provide reasonable assistance DSP, its
Affiliates and sublicensees.

 

4.2.2           Non-Territory
Data. Intercept shall make available to DSP, its Affiliates and Third Party subcontractors any clinical and non-clinical
data, post-marketing data and information which is generated by or in connection with Intercept and its licensees’ Development
of the Compound and Product, both in the Field and with respect to Additional Indications outside the Territory (the “Non-Territory
Data”), which data and information may be used by DSP for [***] in connection with its Development, Commercialization
and/or Manufacturing, as well as its activities to gain Regulatory Approval for the Product in the Field in the Territory.
Intercept shall maintain Non -Territory Data in conformity with all applicable Laws and regulations and in a good scientific manner
appropriate for patent and regulatory purposes. Intercept shall use Commercially Reasonable Efforts to cause any Third Party or
Affiliate who is engaged in the Development of the Compound or Additional Indications outside the Territory to provide access to
DSP and its Affiliates for the Non-Territory Data for [***].

 

4.3           Necessary
Third Party Patents. In the event that DSP determines, in the exercise of sound business judgment, it is necessary to license
or acquire Necessary Third Party Patents in connection with the Development, Manufacture or Commercialization of the Product in
the Field in the Territory, it shall so notify Intercept in writing explaining the reasons therefor, following which the Parties
shall engage in good faith discussions concerning such matter. DSP’s request for Necessary Third Party Patents shall require
Intercept’s prior consent, which shall not be unreasonably withheld or delayed.

 

4.4           Records.
 DSP shall maintain scientific records, in sufficient detail and in good scientific manner appropriate for patent and regulatory
purposes, which will fully and properly reflect all work done and results achieved in the performance of the Development and Commercialization
activities with respect to the Product in the Field in the Territory; all of the foregoing in conformity with standard pharmaceutical
industry practices, the terms and conditions of this Agreement, and all applicable Laws and regulations (including re-examination
systems for post-marketing information). DSP shall provide Intercept with reasonable access to the scientific records maintained
by DSP pursuant to this Section 4.4 which may be used by Intercept in pursuance of its Development activities for the Compound
and the Product outside the Territory.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
15

    	 

    

 

4.5           Cooperation.
Except as expressly forth herein, each Party shall, at its own cost and expense, provide all reasonable assistance and take all
actions reasonably requested by the other Party that are necessary or desirable to enable the Development and Commercialization
of the Product in the Field in the Territory. Further, Intercept shall provide reasonable assistance to DSP to prepare the regulatory
materials for Regulatory Approval and to respond to Regulatory Authorities’ inquiries and investigation relating to analysis
of data arising from non-clinical studies, pre-clinical studies and/or clinical trials conducted by Intercept. In the event that
a Regulatory Authority and/or DSP reasonably requests Intercept to disclose its data and documentation related to the Intercept
Technology for an IND or NDA to be prepared or filed outside the Territory, Intercept shall cooperate with this request by providing
such Regulatory Authority and DSP with the requested data and documentation. In the event that DSP reasonably requests to audit
Intercept and its sub-contractors or licensees, Intercept shall, and shall cause its licensees and sub-contractors to, allow such
audit, subject to customary prior notice requirements.

 

5.          REGULATORY
MATTERS

 

5.1           Commercially
Reasonable Efforts. DSP shall use Commercially Reasonable Efforts, at its own expense, with respect to all regulatory activities
concerning the Development and Commercialization of the Products in the Field in the Territory. DSP shall have sole responsibility
for all pricing and reimbursement approval proceedings relating to each Product in the Field in the Territory. In the event
that DSP wishes to commence Development of the Product in China following Intercept’s receiving Regulatory Approval in the
U.S. and prior to the receipt of Regulatory Approval in Japan, Intercept shall cooperate with DSP based on mutual good faith discussions.
Upon reasonable prior notice and during normal business hours, Intercept shall, and shall cause its Affiliates and its Third Party
sub-contractors to whom all or a part of the Development outside the Territory has been entrusted or contracted, to allow the inspection
by a Regulatory Authority which is required as a condition of Regulatory Approval for the Product in the Field in the Territory.
DSP shall use its Commercially Reasonable Efforts to provide any information concerning such inspection to Intercept in a timely
manner. Intercept shall manage, but shall permit DSP or its designated representatives to be present at any inspection conducted
by such Regulatory Authority. If any issue or concerns are raised concerning the Development of the Compound or the Product in
connection with the inspection by such Regulatory Authority, Intercept shall immediately inform and discuss with DSP to solve the
issue, including any recommendations made by the Regulatory Authority.

 

5.2           Ownership
of Regulatory Approvals. DSP (or its designated Affiliate or sublicensee) shall be the holder of all Regulatory Approvals
issued by Regulatory Authorities with respect to the Product in the Field in the Territory and shall be responsible, at its own
cost, for preparing and, subject to Section 5.1 hereof, drafting all regulatory filings in the Territory (including any supplements
or modifications thereto). DSP (or through its designated Affiliate or sublicensee) shall, subject to Section 5.1 above, be responsible
for communicating with and negotiating with all Regulatory Authorities in the Territory and shall keep Intercept informed of the
status of regulatory filings.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
16

    	 

    

 

5.3           Pharmacovigilance.
The Parties agree to handle safety information including adverse events occurring or having occurred in connection with the
use of the Compound or the Product in accordance with applicable Laws and requirements of relevant Regulatory Authorities. The
Parties shall exchange all safety information including adverse events occurring or having occurred in connection with the use
of the Compound or the Product. The Parties shall execute a separate agreement relating to safety matters on the Compound or the
Product including the procedure for the exchange of safety information during the Term of the Agreement.

 

6.          MANUFACTURING

 

6.1           Clinical
Supply. Intercept shall, by itself or through its Third Party contract manufacturers, supply to DSP (or its Affiliates,
sublicensees or sub-contractors) all quantities of Clinical Supplies of the Product (packaged or prepackaged) required by DSP to
Develop the Product in the Field in the Territory and for quality control analysis. The Parties shall discuss in good faith and
cooperate with each other with respect to the negotiation of a manufacturing and clinical supply agreement (the “Clinical
Supply Agreement”) governing the supply of Clinical Supplies of the Product (packaged or pre-packaged). Intercept undertakes
to improve quality assurance system and /or organization to
supply DSP (or its Affiliates, sublicensees or sub-contractors) with Clinical Supply, including permitting and causing any of its
Third Party sub-contractors to permit, an audit by DSP for quality assurance purposes. The Clinical Supply Agreement shall include,
among other customary provisions, the following or substantially equivalent provisions:

 

6.1.1           Intercept
shall, before entering into any negotiations for an agreement with a Third Party contract manufacturer of Clinical Supplies for
supply to DSP (or its Affiliates, sublicensees or sub-contractors) hereunder notify DSP of the fact. Thereafter, DSP shall have
the right to provide input within thirty (30) days regarding the terms of such agreement (as well as any amendments thereof), review
and comment on the draft agreement and participate in person in the negotiation of such agreement. However, Intercept shall have
final determination of the terms. Further, Intercept shall provide DSP with an execution copy of each agreement between
Intercept and any Third Party contract manufacturer.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
17

    	 

    

 

6.1.2           From
time to time, DSP shall submit to Intercept purchase orders for quantities of Clinical Supplies and Intercept shall supply or have
supplied to DSP such quantities of Clinical Supplies.  DSP’s sole financial liability with respect to Clinical Supplies
shall be to reimburse Intercept for the Actual Costs. DSP shall provide Intercept with non-binding forecasts of DSP’s purchase
orders for Clinical Supplies which may be placed for the initial [***] ([***]) [***] after the Effective Date, and thereafter DSP
shall provide Intercept with non-binding forecasts of DSP’s purchase order for Clinical Supplies [***] ([***]) [***] prior
to the estimated date of placing the purchase order. The purchase orders for Clinical Supplies shall be placed to allow no less
than [***] ([***]) [***] lead time prior to the shipment dates specified in the purchase orders, and upon placement shall be deemed
non-cancelable, unless Intercept indicates that it does not have sufficient stock of Clinical Supplies to accommodate the lead
time specified in DSP’s purchase order, in which event the lead time for the Clinical Supplies for such order shall be determined
by mutual agreement of Intercept and DSP through good faith discussions; provided that should the Parties not reach agreement on
an adjusted lead time, then DSP may cancel the relevant purchase order. Notwithstanding the foregoing, Intercept shall use best
reasonable efforts to comply with the purchase orders. The risk of loss and damage for, and the title in, Clinical Supplies supplied
hereunder shall pass to DSP upon delivery of the Clinical Supplies to the carrier designated by DSP. Shipment shall be FCA an international
airport or port designated by Intercept as defined in INCOTERMS 2010, as amended. DSP may at any time elect to Manufacture or have
Manufactured the Clinical Supplies, provided such election will not terminate any purchase orders for Clinical Supplies submitted
by DSP to Intercept prior to notice of such election.

 

6.1.3           Intercept
shall invoice DSP for such Clinical Supplies with each shipment, clearly setting forth the calculation of the Actual Cost for the
shipped order of the Clinical Supplies and DSP shall pay such invoices within thirty (30) days of its receipt of such invoice.

 

6.2           Commercial
Supply. Intercept shall supply DSP (or its Affiliates, sublicensees or sub-contractors) with all DSP’s requirements
of the Commercial Supplies until such time as DSP provides written notice to Intercept that DSP is ready to commence Manufacturing
(or have Manufactured) of the Product on its own or on its behalf. Intercept shall be responsible for the Manufacture of the Commercial
Supplies in compliance with the Specifications, GMP and all applicable Laws. The Parties shall discuss in good faith and cooperate
with respect to the negotiation of a manufacturing and supply agreement (the “Commercial Supply Agreement”) governing
the supply of the Commercial Supply by or on behalf of Intercept, to DSP (or its Affiliates, sublicensees or sub-contractors) for
the Commercialization of the Product in the Field in the Territory at the initiation of the Phase III Clinical Trials in Japan.
In the event that manufacturing batches for the U.S. are conducted prior to the commencement of Phase III Clinical Trials in Japan,
Intercept shall afford DSP a reasonable opportunity to comment upon and make suggestions with respect to such manufacturing validation,
which Intercept shall use good faith efforts to incorporate on a going-forward basis. The Commercial Supply Agreement shall contain,
in addition to other customary terms, the following terms and conditions:

 

6.2.1           The
transfer price for the first three orders of the Commercial Supply supplied to DSP by or on behalf of Intercept following receipt
of Marketing Approval in Japan shall be calculated at the rate of [***] percent ([***]%) of [***] in effect on the date upon which
each such order is sent to Intercept by DSP.

 

6.2.2           The
fourth and subsequent orders of the Commercial Supply supplied to DSP by or on behalf of Intercept following receipt of Marketing
Approval in Japan shall be based on the Actual Cost plus [***] percent ([***]%) of the Actual Costs. The target actual cost is
less than or equal to $[***] (the “Target Actual Cost”). In the event that the Actual Cost exceeds such Target Actual
Cost, Intercept shall use Commercially Reasonable Efforts to reduce the Actual Cost. Should that not be possible, the Parties shall
discuss in good faith an increased Target Actual Cost for the Product.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
18

    	 

    

 

6.2.3           Intercept
shall, before entering into any negotiation for an agreement with a Third Party contract manufacturer of Commercial Supplies to
DSP hereunder, notify DSP of the fact. Thereafter, DSP shall have the right to provide input regarding the terms of such agreement
(as well as any amendments thereof), review and comment on the draft agreement and participate in person in the negotiation of
such agreement.  Further, Intercept shall provide DSP with an execution copy of each agreement between Intercept and any
Third Party contract manufacturer.

 

6.3           Additional
Supply Terms and Conditions. In addition to the supply terms and conditions to be incorporated in the Clinical Supply Agreement
and the Commercial Supply Agreement pursuant to Sections 6.1 and 6.2 respectively, each of the Clinical Supply Agreement and the
Commercial Supply Agreement shall also include provisions substantially similar to the following:

 

6.3.1           Conformity.
All Products Manufactured and supplied by or on behalf of Intercept under each of the Clinical Supply and the Commercial Supply
Agreement shall strictly conform to (i) the Specifications and (ii) GMP.

 

6.3.2           Change
Control. If Intercept wishes to change the Specifications, the location of the Manufacturing site, the Manufacturing process,
or the raw materials, which in the case of each of the foregoing requires approval of the Regulatory Authorities, Intercept shall
first obtain the prior written consent of DSP (not to be unreasonably withheld) and provide the information relevant to such proposed
change to DSP, following which DSP shall use Commercially Reasonable Efforts to obtain any required approval from the Regulatory
Authorities. Intercept shall provide DSP with all reasonable assistance with respect to the foregoing. When Intercept wishes to
make any change in the Manufacturing process or the raw materials which, in either case, is subject to a reporting or notification
requirement to Regulatory Authorities, Intercept shall notify DSP sufficiently in advance so that DSP may comply with such reporting
or notification requirements. Prior to initiating any change in the Specifications, the location of the Manufacturing site, the
Manufacturing process, or the raw materials, Intercept and DSP shall discuss in good faith and agree upon the quantity of a reasonable
safety stock of the Product to be maintained until completion of the any proposed change.

 

6.3.3           GMP
Audit by DSP. DSP may audit the facilities of Intercept, its Affiliates or its Third Party subcontractors upon reasonable
prior notice and during normal business hours. Intercept shall allow and shall cause its Affiliate or its Third Party subcontractors
to allow such inspection to the extent such facilities relate to the Manufacture of the Compound and/or the Product. Intercept
shall, and shall cause its Affiliates and Third Party sub-contractors, to use Commercially Reasonable Efforts to implement changes
reasonably requested by DSP as a result of any GMP audit undertaken pursuant to the preceding sentence.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
19

    	 

    

 

6.3.4           Inspection
by Regulatory Authority. Upon reasonable prior notice and during normal business hours, Intercept shall allow, and shall
cause its Affiliates and its Third Party subcontractors to whom all or a part of the Manufacturing process of the Compound and/or
the Product has been entrusted or contracted to allow, the inspection by the Regulatory Authority which is required as a condition
for obtaining or maintaining Regulatory Approval for the Product in the Field in the Territory. DSP shall use its Commercially
Reasonable Efforts to provide any information concerning such audit to Intercept in a timely manner. Intercept shall permit DSP
or its designated representatives to be present at any audit conducted by any Regulatory Authority pursuant to this Section 6.3.4.
If any issue or concerns are raised concerning the Manufacturing of the Compound or Product in connection with the audit by such
Regulatory Authority, Intercept shall immediately inform DSP, including any recommendations made by the Regulatory Authority.

 

6.3.5           Quality
Assurance Agreement. The Parties shall enter into a mutually agreed-upon companion quality agreement (the “Quality
Assurance Agreement”) with respect to each of the Clinical Supply Agreement and the Commercial Supply Agreement, which shall
set forth in detail the quality assurance arrangements and procedures of the Product and the GMP responsibilities between the Parties
prior to the Manufacture of the Compound to be used for the first commercial lot of the Product.

 

6.4           Technical
Transfer. In the event that DSP wishes to commence the Manufacture of the Compound and/or Product itself (including having
the Product Manufactured), DSP shall raise the issue to the JSC for consultation with Intercept with respect to the timing and
other related details of the Technical Transfer of the Intercept Manufacturing Technology so to enable DSP to Manufacture or have
Manufactured the Compound and the Product for Commercialization in the Territory.

 

6.4.1           Immediate
Transfer. Following consultation with the JSC, Intercept shall use Commercially Reasonable Efforts to make available, or
cause to be made available, in either case, within sixty (60) days to DSP, its Affiliates, and its designated Third Party subcontractors,
all relevant information, data, and Intercept Know-How relating to the Intercept Manufacturing Technology. To give effect to the
foregoing, DSP shall have the right to obtain transfer and Intercept shall have the obligation to give immediate transfer free
of charge to DSP, its Affiliates and its designated Third Party subcontractors, without undue delay, of any and all Intercept Manufacturing
Technology necessary to enable DSP to Manufacture or have Manufactured the Compound and/or Product by a Third Party subcontractor
to meet DSP’s requirements (the foregoing, the “Technical Transfer”).

 

6.4.2           Additional
Licenses. In connection with the Technical Transfer, Intercept hereby grants to DSP a non-exclusive right, non-royalty-bearing
license, with the right to sublicense to its Affiliates and Third Party subcontractors, with prior notice to and reasonable approval
of Intercept, to use the Intercept Manufacturing Technology both in the Territory and outside the Territory to engage in the Manufacture
of the Compound and/or Product for Commercialization in the Territory. If any Intercept Manufacturing Technology is within the
control or possession of a Third Party, Intercept shall use Commercially Reasonable Efforts to obtain the cooperation and assistance
of such Third Party in connection with the Technical Transfer.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
20

    	 

    

 

6.4.3           Assistance
and Continued Supply Obligation. Both Parties acknowledge that the process of DSP’s becoming manufacturing-ready
may require reasonable assistance from Intercept, which Intercept agrees to provide as reasonably requested. At the request of
DSP made pursuant to Section 6.4, Intercept shall facilitate the transfer of the Intercept Manufacturing Technology from Intercept’s
contract manufacturers to DSP and/or its contract manufacturers, in which case the expenses reasonably incurred for the Technical
Transfer shall be borne by DSP. During the Term of this Agreement, Intercept shall remain available to answer technology transfer
questions relating to the Intercept Manufacturing Technology. In the event DSP should require any additional technical assistance
beyond the Term of this Agreement, Intercept shall provide such assistance at DSP’s expense to the extent Intercept has personnel
available. Intercept makes no warranty, express or implied, with respect to the Intercept technical assistance. Further, Intercept
shall supply the Clinical Supplies and Commercial Supplies to DSP hereunder until DSP indicates that it is ready to Manufacture
or have Manufactured the Compound or Product. If, notwithstanding Intercept’s Commercially Reasonable Efforts, Intercept
reasonably determines that Manufacture and supply of the Commercial Supply are not practicable for a technical and/or economic
reason, Intercept’s commitment to supply Product may be terminated upon three (3) years prior written notice to DSP, in which
event Intercept shall, (i) at DSP’s option, (x) assign to DSP certain contracts between Intercept and its subcontractors
which are selected by DSP or (y) arrange for DSP to negotiate its own terms and conditions with Intercept’s subcontractors
designated by DSP, and (ii) bear all reasonable cost and effects arising in connection with the Technical Transfer.

 

7.          ADDITIONAL
INDICATIONS OPTION

 

7.1           Development
of Additional Indications for Products. The Parties shall cooperate in good faith in generating ideas and concepts for
Additional Indications for Products.

 

7.2           Grant
of Option. Subject to the terms and conditions of this Agreement and throughout the Term of the Agreement, Intercept hereby
grants to DSP the exclusive option to an exclusive license to Products in the Territory for each and every Additional Indication
(both present and future) on the same terms and conditions as provided for the Product in the Field (each such Additional Indication,
an “Additional Indication Option”). For the avoidance of doubt, the rights granted to Intercept pursuant to Section
7.3.3 below with respect to Third Parties shall have effect only in the event that DSP declines to exercise a particular Additional
Indications Option.

 

7.3           Exercise
Period; Exercise of Additional Indications Option. The period during which DSP may exercise each Additional Indications
Option shall commence on the date that Intercept notifies DSP in writing of the “first patient” in a Phase III Clinical
Trial for the target Additional Indication by Intercept and/or its licensees outside the Territory (the “Additional Indications
Option Commencement Notice”) and shall end on the [***] ([***]) [***] of the receipt by DSP of the Additional Indications
Option Commencement Exercise Notice (the foregoing period, the “Additional Indications Exercise Period”). DSP may exercise
each Additional Indications Option at any time during the Additional Indications Exercise Period by (i) providing written notice
to Intercept that DSP has obtained required internal approvals to commence a pivotal clinical study for the target Additional Indication
(the “Additional Indications Option Exercise Notice”) and (ii) making payment of the applicable fee indicated in Section
7.3.1 below to a bank account designated by Intercept (each payment, an “Additional Indications Option Fee”) within
thirty (30) calendar days of dispatch of the Additional Indications Option Exercise Notice. The Additional Indications Option shall
be deemed duly exercised on the date when Intercept has received both items (i) and (ii) (the “Additional Indications Option
Effective Date”).

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
21

    	 

    

 

7.3.1           Additional
Indications Option Fee. The Additional Indications Option Fee shall be US$[***] ([***] U.S. Dollars) for each Additional
Indication. For the sake of clarity, no Additional Indications Option Fee is required to be paid upon the exercise of any Additional
Indications Option in China. Upon the exercise of each Additional Indications Option, DSP shall be entitled to exercise the rights
granted to it under Section 7.1 with respect to the target Additional Indication in the Territory as it is constituted on the Additional
Indications Option Effective Date and as it may thereafter be constituted through the exercise by DSP of the Country Option.

 

7.3.2           License
Grant. Following each Additional Indications Option Effective Date, (i) the definition of “Field” shall be
automatically amended and expanded to include the target Additional Indication and (ii) Intercept shall provide DSP with any copies
and access to any Know-How or Technology in its Control relating to the target Additional Indication.

 

7.3.3           Non-Exercise
of Additional Indication Option.  If DSP declines in writing to exercise any particular Additional Indications Option within
the Additional Indications Exercise Period, then Intercept may grant the right to a Third Party to develop and commercialize the
target Additional Indication in the Territory; provided that should any discussions with a Third Party not result in a binding
written agreement for the target Additional Indication, then DSP’s Additional Indications Option with respect to such target
Additional Indication shall revive and the provisions of Article 7 shall apply thereto.

 

7.4.          Separate
Nature. For the sake of clarification, the exercise of the Additional Indications Option by DSP in connection with one
of the Additional Indications shall not be construed as relieving Intercept of the obligation of complying with Articles 7.1-7.3
above with respect to each Additional Indication.

 

8.          COUNTRY
OPTION

 

8.1           Grant
and Exercise of Country Option. Intercept hereby grants to DSP the exclusive option to add any or all of the following
countries to the Territory: Korea, Taiwan, Malaysia, Vietnam, the Philippines, Thailand, Singapore and Indonesia (the “Country
Option”). DSP shall have a separate exclusive option with respect to each of the countries listed in the preceding sentence,
such that the exercise by DSP of the Country Option with respect to one country shall not be deemed a waiver of its rights with
respect to the other countries listed in the first sentence of this Section 8.1. Upon the exercise of the Country Option by DSP
with respect to any particular country, such country shall be automatically deemed a part of the Territory. The exercise of the
Country Option with respect to one country shall automatically include all Fields in the Territory.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
22

    	 

    

 

8.2           Country
Option Fee. The Country Option shall be exercisable at DSP’s discretion at any time from the Effective Date to the
date of issuance of Marketing Approval for Commercialization of the Product in the Field in Japan by providing written notice of
its intent to the exercise the Country Option (the “Country Option Exercise Notice”). DSP shall pay an exercise fee
of US$[***] ([***] U.S. Dollars) per each country, due within [***] ([***]) [***] following exercise of the relevant Country Option.
Unless exercised in accordance with this provision, or as otherwise set forth in this Agreement, the Country Option shall expire
on the date upon which Regulatory Approval for the sale of the Product in the Field in Japan is issued.

 

8.3           Third
Party Offers. Notwithstanding the exclusive option granted to DSP in Section 8.1 hereof, following the [***] ([***]) [***]
of the Effective Date, in the event that Intercept desires to accept or make a bona fide offer from a Third Party for the exclusive
development and/or commercialization rights for the Product in countries listed in the first sentence of Section 8.1 (the “Target
Country”), Intercept shall immediately notify DSP in writing and indicate the Target Country, desired indications, and provide
a summary of the material financial terms and conditions of the offer (the “Third Party Offer Notice”). Within forty-five
(45) calendar days of receipt of the Third Party Offer Notice, DSP shall notify Intercept in writing whether or not it wishes to
exercise the Country Option for the Target Country (the “Country Exercise Option Notice”). If DSP desires to exercise
the Country Option for the Target Country, DSP shall make the payment of the Country Option Fee for the Target Country to a bank
account designated by Intercept no later than thirty (30) calendar days following dispatch of the Country Exercise Option Notice.
If DSP declines to exercise the Country Option for the Target Country, then Intercept shall be free to negotiate with the Third
Party on terms no less materially favorable than those contained in the Third Party Offer Notice; provided that should such negotiations
fail, then DSP’s Country Option shall revive with respect to the Target Country.

 

8.4           Right
of First Negotiation. Prior to accepting or making a bona fide offer from or to a Third Party with respect to the exclusive
development and commercialization rights for the Compound in the Field (including all Additional Indications) in the U.S. and Canada,
Intercept shall promptly deliver a written notice thereof to DSP. Intercept and DSP shall engage in good faith negotiations, but
to avoid any confusion, Intercept shall also be free to engage in good faith negotiations with such Third Party Offeror; provided
that should the parallel discussions between Intercept and such Third Party and Intercept and DSP not result in a binding agreement,
then this Right of First Negotiation shall revive with respect to any subsequent offers from or to third parties with respect to
the rights described in this Section 8.4. Further, in the event that DSP terminates the Agreement based on the cessation of development
of the Compound or the Product by Intercept, then immediately following such termination, DSP and Intercept shall engage in good
faith discussions concerning the exclusive development and commercialization rights for the Compound in the Field (including all
Additional Indications) in the U. S. and Canada.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
23

    	 

    

 

9.          PAYMENTS

 

9.1           Upfront
Fee. DSP shall make a one-time, non-refundable, non-creditable payment to Intercept of US$15,000,000 (Fifteen Million Dollars)
(“Upfront Fee”) within thirty (30) calendar days of the Effective Date to a bank designated in writing by Intercept.
It is acknowledged that this upfront fee shall include the consideration for the rights granted to DSP in Section 8.4. All references
to “fiscal year” shall refer to the Japanese fiscal year which ends on March 31 of each calendar year and indicate
that it applies to all sub-sections in Article 9 and also Article 10.

 

9.2           Milestone
Payments. The milestone payments set forth in this Section 9.2 shall be paid only once, upon the first achievement
of the applicable milestone event in the applicable listed geographic area. For purposes of determining whether a milestone event
set forth in Sections 9.2.2 and 9.2.3 has occurred (and without creating an obligation to pay the milestone more than once
as set forth in the preceding sentence), Net Sales for each fiscal year shall be aggregated for all Products sold in the Territory
during the relevant fiscal year.

 

9.2.1           Within
thirty (30) calendar days following the occurrence of each of the events set forth below for the Product, DSP shall pay to Intercept
each of the non-refundable, non-creditable milestone payments set forth below:

 

	Milestone Event	Milestone Payment
	 	 
	Development Milestones	 
	 	 
	Japan	 
	 	 
	PBC-Commencement of Phase III Clinical Trial	US$[***]
	 	 
	PBC-Marketing Approval	US$[***]
	 	 
	NASH-2nd indication-Marketing Approval	US$15,000,000.00
	 	 
	Additional Indications-Marketing Approval	US$[***]
	 	 
	China	 
	 	 
	PBC-Commencement of Phase III Clinical Trial	US$[***]
	 	 
	PBC-Marketing Approval	US$[***]
	 	 
	NASH-2nd indication-Commencement of Phase III Clinical Trial	US$[***]
	 	 
	NASH-Marketing Approval	US$10,000,000.00
	 	 
	Additional Indications-Commencement of Phase III Clinical Trial	US$[***]
	 	 
	Additional Indications-Marketing Approval	US$[***]

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
24

    	 

    

 

	 	 
	United States	 
	 	 
	PBC-Marketing Approval	US$3,000,000.00*
	 	 
	NASH Successful NIH Clinical Trial	US$[***]**
	 	 
	NASH-Marketing Approval	US$[***]***
	 	 
	Other Asian countries	 
	 	 
	PBC-Initiation of clinical trial	US$[***]
	 	 
	PBC-Marketing Approval	US$[***]
	 	 
	Additional Indications-Initiation of clinical trial	US$[***]
	 	 
	Additional Indications-Marketing Approval	US$[***]

 

*In the event that the WAC exceeds US$[***]
per day before approval in Japan, then an amount of US$2,000,000.00 shall be paid as an additional milestone payment (i.e., a total
of US$5,000,000.00).

 

**The milestone payment for the NASH NIH
clinical trial is conditioned on the results being available no later than [***], and supporting a decision by the JSC to continue
Development of the Product for the NASH indication.

 

***In the event that (i) the NASH Marketing
Approval in the U.S. occurs prior to the end of 2017 (i.e., based on a sNDA submission of the NIH clinical trial data) and DSP
is able to use these data in support of a NDA submission in Japan, then the additional amount of US$[***] shall be paid (i.e.,
a total of US$[***]); but (ii) if the NASH Marketing Approval in the U.S. occurs after the Marketing Approval in Japan, then no
milestone payment of US$[***] as set forth in the chart above shall be due.

 

9.2.2           Sales
Milestones. Within sixty (60) calendar days following the end of each calendar quarter in which any event set forth below
occurs, DSP shall notify Intercept of such event via the reports as indicated in Section 10.1 and within sixty (60) calendar days
following the end of such calendar quarter shall pay to Intercept each of the non-refundable, non-creditable milestone payments
set forth below. For the avoidance of doubt, in the event that two or more of the events set forth below occur during the same
calendar quarter, then DSP shall pay to Intercept the aggregate of the applicable sales milestone payments set forth below in the
manner set forth in the first sentence of this Section 9.2.2.:

 

	Net Sales exceed US$50 Million (one time only payment)  	US$5,000,000.00	 
	 	 	 
	Net Sales exceed US$100 Million (one time only payment)  	US$10,000,000.00	 

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
25

    	 

    

 

	Net Sales exceed US$200 Million (one time only payment)  	US$20,000,000.00	 
	 	 	 
	Net Sales exceed US$400 Million (one time payment only)	US$40,000,000.00	 
	 	 	 
	Net Sales exceed US$1,200 Million (one time payment only)	US$120,000,000.00	 

 

9.2.3           Royalty
Tiers. DSP shall pay to Intercept a royalty of [***] percent ([***]%) based on total annual Net Sales of all Products in
the Field in the Territory for each fiscal year (i.e. ending on March 31 of each calendar year) in which the Net Sales of all Products
in the Territory for such year is less than US$[***] (the “First Tier Royalty Rate”). DSP shall pay to Intercept a
royalty of [***] percent ([***]%) based on total annual Net Sales of all Products in the Field in the Territory for each fiscal
year in which the Net Sales of all Products in the Territory for such year is US$[***] or more but less than US$[***] (the “Second
Tier Royalty Rate”). DSP shall pay to Intercept a royalty of [***] percent ([***]%) based on total annual Net Sales of all
Products in the Field in the Territory for each fiscal year in which the Net Sales of all Products in the Territory for such year
exceeds US$[***] (the “Third Tier Royalty Rate”). Notwithstanding the foregoing, the transfer price for the [***] of
the Commercial Supplies to DSP by Intercept following receipt of Marketing Approval in Japan shall be calculated in accordance
with Section 6.2.1 and shall be deemed to including the running royalty payment, and accordingly no further royalty payments by
DSP shall be required with respect thereto; however in no event will the transfer price be less than the [***] percent ([***]%)
plus the applicable First, Second or Third Tier Royalty Rate.

 

9.3           Reduced
Royalty Rates for Net Sales 

 

9.3.1           Reduced
Royalty Rates in Countries Excluding Japan. If at any time [***] of the First Commercial Sale in a country in the Territory
(excluding Japan), a generically equivalent product enters the market and captures more than [***] percent ([***]%) of the market
share as determined by unit sales (“Market Share”) for [***], then the country shall be designated an “Eroded
Country” beginning the first day of the next calendar quarter. For the purpose of determining royalty payments due on an
Eroded Country’s Net Sales, total annual Net Sales will be assessed country-by-country and not aggregated with other country
Net Sales in the Territory. The reduced royalty rates that shall apply in an Eroded Country are as follows:

 

		i.	Eroded Country Net Sales up to US$[***] assessed at [***]
percent ([***]%); and

		ii.	Eroded Country Net Sales of US$[***] up to (but less
than) US$[***] assessed at [***] percent ([***]%); and

		iii.	Eroded Country Net Sales of US$[***] or more assessed
at [***] percent ([***]%).

 

Thereafter, DSP’s Market Share in
each subsequent calendar quarter will be assessed and if the Market Share is restored to [***] percent ([***]%) or above then the
royalty rates set forth in Section 9.2.3 shall apply again to Net Sales in that country, which shall be aggregated with all other
Net Sales (excluding Eroded Country Net Sales), and if the Market Share remains or falls back below [***] ([***]%) in any calendar
quarter, then the Eroded Country reduced royalty rates set forth in this Section 9.3.1 shall apply. The JSC shall be responsible
for determining the most effective means to implement an effective Market Share, Net Sales and royalty tracking system in the Territory
in order to give effect to DSP’s royalty payment obligations hereunder.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
26

    	 

    

 

9.3.2           Reduced
Royalty Rates in Japan. The royalty rates set forth in Section 9.2.3 shall remain in effect with respect to total annual
Net Sales in Japan until such time as (i) the substance patent in Japan expires (after taking into account all available extensions)
and (ii) a generically equivalent product enters the market and captures more than [***] percent ([***]%) of the Market Share for
[***]. Thereafter, beginning the first day of the next calendar quarter, Japan shall be designated an Eroded Country and DSP shall
pay Intercept a reduced royalty of [***] percent ([***]%) on total annual Net Sales in Japan for [***] of such designation, [***]
percent ([***]%) on total annual Net Sales for the [***] of such designation, and then [***] percent ([***]%) on total annual Net
Sales thereafter. Once Japan has been designated as an Eroded Country, DSP’s Market Share in each subsequent calendar quarter
will be assessed and if the Market Share is restored to [***] percent ([***]%) or above then the royalty rates set forth in Section
9.2.3 shall apply again to Net Sales in Japan, which shall be aggregated with all other Net Sales (excluding Eroded Country Net
Sales), and if the Market Share remains or falls back below [***] percent ([***]%) then the Eroded Country reduced royalty rates
set forth in this Section 9.3.2 shall apply at the applicable royalty rate based on the cumulative number of quarters that had
previously passed while Japan had been designated an Eroded Country. The JSC shall be responsible for determining the most effective
means to implement an effective Market Share, Net Sales and Royalty tracking system in the Territory in order to give effect to
DSP’s royalty payment obligations hereunder.

 

9.4           Necessary
Third Party Technology Payments. DSP shall be entitled to deduct [***] percent ([***]%) of all royalties it is required
to pay to a Third Party for Necessary Third Party IP under any agreement to license or acquire intellectual property used in the
Development or Commercialization of the Product in the Field in the Territory up to a maximum of [***] percent ([***]%) for purposes
of Section 9.2.3, or [***] percent ([***]%) for purposes of Section 9.3.1 or 9.3.2 of the applicable royalty rate.

 

10.         PAYMENT;
RECORDS; AUDITS

 

10 .1         Payment;
Reports.  Royalties shall be calculated and reported during the fiscal year for each calendar quarter. All payments due
to Intercept under this Agreement shall be paid within sixty (60) calendar days after the end of each calendar quarter. DSP shall
deliver to Intercept (i) within thirty (30) calendar days after the end of each calendar quarter a report of gross sales of Product
in the Territory and (ii) within sixty (60) days after the end of each calendar quarter, a report certified by DSP as accurate
to the best of its ability based on information then available to DSP, setting forth for such calendar quarter the following information
on a country-by-country basis and other such information to permit confirmation of the accuracy of the information for which payments
are calculated including: (i) gross and Net Sales of Product, (ii) the basis for any adjustments to the royalty payable
for the sale of Product, and (iii) the royalty due hereunder for the sale of Product. All payments hereunder shall be payable
in U.S. dollars. All payments owed under this Agreement shall be made by wire transfer in immediately available funds to a bank
and account designated in writing by Intercept. Conversion of foreign currency to U.S. Dollars shall be made at the Telegraphic
Transfer Selling (TTS) rate published by Sumitomo Mitsui Banking Corporation or any other mutually agreed upon source, in effect
on the last day of each calendar month within each calendar quarter to the Net Sales that was deemed sold during such month with
respect to royalty and sales milestones payments under Sections 9.2.2 and 9.3 and for the previous day of the notification of the
development milestone under Section 9.2.1.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
27

    	 

    

 

10.2         Tax
Withholding.  Intercept shall be responsible for any income taxes payable by Intercept on payments made to it under this
Agreement. If applicable Laws require that taxes be deducted and withheld from a payment due from DSP to Intercept under this Agreement,
DSP shall (i) deduct those taxes from the payment; (ii) pay the taxes to the proper taxing authority; and (iii) send evidence of
the proof of payment to Intercept promptly following that payment. Intercept shall provide DSP with documentation necessary for
DSP to file an application with the applicable tax authorities to avoid or reduce withholding or other applicable taxes under any
applicable tax treaty.  

 

10.3         Audits.
During the Term and for a period of three (3) years thereafter, DSP 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 the Field in the Territory and
calculations of Net Sales and payments required under this Agreement in sufficient detail to permit Intercept to confirm the accuracy
of all payments due to it hereunder. Notwithstanding the foregoing, should applicable Law in the Territory require DSP to retain
records of the nature described in the preceding sentence for a period longer than that set forth in the preceding sentence, DSP
shall retain such records for the longer period; provided that Intercept shall advise of any applicable record-keeping requirements
imposed by laws outside the Territory. Intercept shall have the right to cause an independent, certified public accountant reasonably
acceptable to DSP to audit such records to confirm Net Sales, royalty, milestone and other payments for a period covering up to
but not more than the preceding twelve (12) calendar quarters; provided that any such accountant shall have previously entered
into a confidentiality agreement reasonably satisfactory to DSP limiting its disclosure of such information to authorized representatives
of the Parties or as required under applicable Laws. Any such inspection shall be for the sole purpose of verifying the calculation
of payments on Net Sales of the Products in the Field in the Territory by DSP, and its Affiliates or sublicensees and milestone,
royalty and other payments paid by DSP under this Agreement. The accountant shall only disclose to Intercept the findings of the
audit and the specific details concerning any discrepancies. No other information shall be provided to Intercept. Such audit rights
may be exercised during normal business hours upon reasonable prior written notice to DSP; provided that such audit right may be
exercised no more than once in any twelve (12) -month period. Prompt adjustments shall be made by the Parties to reflect the results
of such audit. Intercept shall bear the full cost of such audit unless such audit discloses an underpayment by DSP of more than
[***] percent ([***]%) of the amount of royalties or other payments due under this Agreement, in which case, DSP shall bear the
full cost of such audit.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
28

    	 

    

 

11.         TREATMENT
OF CONFIDENTIAL INFORMATION

 

11.1         Confidential
Obligations. DSP and Intercept each recognize that the other Party’s Confidential Information constitutes highly
valuable and proprietary confidential information. Intercept and DSP each agree that during the Term of this Agreement and for
five (5) years thereafter, it will keep confidential, and will cause its employees, consultants, contractors, Affiliates and sublicensees
to keep confidential, all Confidential Information of the other Party. Neither Intercept nor DSP, nor any of their respective employees,
consultants, Affiliates or sublicensees shall use Confidential Information of the other Party for any purpose whatsoever other
than exercising any rights granted to it or reserved by it hereunder. Without limiting the foregoing, each Party may disclose information
to the extent such disclosure is reasonably necessary to (i) file and prosecute patent applications and/or maintain patents which
are filed or prosecuted in accordance with the provisions of this Agreement, or (ii) file, prosecute or defend litigation in accordance
with the provisions of this Agreement or (iii) comply with applicable Laws, regulations or court orders; provided, however, that
if a Party is required to make any such disclosure of the other Party’s Confidential Information in connection with any of
the foregoing, it will give reasonable advance notice to the other Party of such disclosure requirement and will use reasonable
efforts to assist such other Party in efforts to secure confidential treatment of such information required to be disclosed.

 

11.2         Publication.
If either Party plans to publish or present the results of any studies or other data regarding the Compound, the Product or Additional
Indications conducted in and outside the Territory, the Party shall submit the draft of the publication, translated into English,
to the other no later than four (4) weeks prior to the planned submission for publication for approval, unless such disclosure
requires immediate publication due to disclosure requirements of the U.S. Securities and Exchange Commission, the NASDAQ stock
exchange or any other stock exchange on which securities issued by a Party are traded and Intercept has advised DSP of the deadline
for disclosure in a sufficiently timely manner. As soon as a Party is aware of a deadline for submitting an abstract for an upcoming
scientific meeting, it shall notify the other Party in writing and the Parties shall use Commercially Reasonable Efforts to exchange
comments on the proposed abstract in a timely manner to facilitate the publication/presentation of the proposed abstract. Otherwise,
any publication shall need the other Party’s prior written consent, which shall not be unreasonably withheld. Any comment,
reasonable request for modification or reasonable rejection must be made within as quickly as practically possible from the receipt
of the draft. Failure to quickly make such comments shall be conclusively deemed to constitute approval of such publication or
presentation. For the avoidance of doubt, this Section 11.2 shall apply to publications made by either Party both in the Territory
and outside the Territory.

 

11.3         Publicity.
DSP and Intercept may, by mutual written agreement, issue a press release announcing the execution of this Agreement, which shall
be substantially in a form approved by the Parties. Except with respect to such initial release or as otherwise required by applicable
Laws (including disclosure requirements of the U.S. Securities and Exchange Commission, the NASDAQ stock exchange or any other
stock exchange on which securities issued by a Party are traded), neither Party shall issue an additional press release or public
announcement relating to this Agreement without the prior written approval of the other Party, which shall not be unreasonably
withheld or delayed. In the event that a Party wishes to refer to the other Party or the transactions under this Agreement in promotional
or other communications with prospective customers and investors, such Party shall first provide the other Party with advance notice
of such proposed disclosure and the form, substance and intended use of such proposed disclosure and obtain the prior written approval
of the other Party to the form, substance and intended use of such proposed disclosure.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
29

    	 

    

 

12.         FILING,
PROSECUTION AND MAINTENANCE OF PATENT RIGHTS

 

12.1         Patent
Filing, Prosecution and Maintenance. Subject to the other terms of this Section 12.1, Intercept shall be responsible for
preparing, filing, prosecuting, obtaining and maintaining, all Intercept Patents in the Territory. Intercept (i) will provide
DSP with a copy of any proposed patent application or prosecution or other document relating to a patent or application within
the Intercept Patents and to the Field (and the Additional Indications) for review and comment reasonably in advance of filing
which shall under no circumstances be less than thirty (30) days, and (ii) will keep DSP reasonably informed of the status of such
filing, prosecution and maintenance.

 

12.2         Enforcement.
If, during the Term, either Party learns of any actual, alleged
or threatened infringement by a Third Party of any Intercept Patent under this Agreement, such Party shall promptly notify the
other Party and shall provide such other Party with available evidence of such infringement. Intercept shall have the first right
(but not the obligation), at its own expense and with legal counsel of its own choice, to bring suit (or take other appropriate
legal action) against any actual, alleged or threatened infringement of the Intercept Patent in the Field in the Territory; provided
that the settlement of such matter shall require DSP’s consent, not to be unreasonably withheld or delayed. DSP shall have
the right, at its own expense, to be represented in any such action by counsel of DSP’s own choice. If Intercept does not
file any action or proceeding against any such material infringement,
with material infringement determined using reasonable commercial standards (including obtaining the advice of patent counsel),
within three (3) months after the later of (i) DSP’s notice to Intercept hereunder, (ii) Intercept’s notice to DSP
hereunder, or (iii) a written justified request from DSP to
take action with respect to such infringement, then DSP shall have the right (but not the obligation), at its own expense, to bring
suit (or take other appropriate legal action) against such actual, alleged or threatened infringement, with legal counsel of its
own choice, including the right to settle any such suit without the prior consent of Intercept, who shall render all assistance
reasonably required or requested by DSP. Irrespective of which party is taking the lead with respect to the defense of a claim,
the party taking the lead shall keep the other party reasonably informed as to the status of any such action and shall give due
regard to the comments and suggestions of the other Party with respect to the defense of such claims. Any damages, monetary awards
or other amounts recovered, whether by judgment or settlement, pursuant to any suit, proceeding or other legal action taken under
this Section 12.2, shall applied as follows:

 

(a)          first,
to reimburse the Parties for their respective costs and expenses (including reasonable attorneys’ fees and costs and costs
for providing assistance) incurred in prosecuting such enforcement action, and

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
30

    	 

    

 

(b)          second,
any amounts remaining shall be allocated [***] percent ([***]%) to the Party initiating the legal action
and [***] percent ([***]%) to the other Party, if the other Party provides material assistance, as
determined using reasonable commercial standards, and if not then, [***] ([***]%) to the initiating Party.

 

If a Party brings any such action or proceeding
hereunder, the other Party agrees to be joined as party plaintiff if necessary to prosecute such action or proceeding, and to give
the Party bringing such action or proceeding reasonable assistance and authority to file and prosecute the suit; provided, however,
that neither Party shall be required to transfer any right, title or interest in or to any property to the other Party or any Third
Party to confer standing on a Party hereunder.

 

12.3         Defense.
Each Party shall promptly notify the other Party in writing of any allegation by a third Party that the activity of either of the
Parties or their Affiliates or sublicensees pursuant to this Agreement infringes or may infringe the intellectual property rights
of such Third Party. Intercept shall have the right to control, at its own expense, the defense of any claim alleging that the
Development, Manufacturing or Commercialization of the Product in the Field in the Territory infringes any such Third Party rights.
If Intercept fails to proceed in a timely manner with respect to such defense, DSP shall have the option to assume control the
defense of such claim. As a general matter, the Parties acknowledge that Intercept, as the licensor of the Intercept Technology
shall, in principle, be responsible for all costs associated with maintaining validity of the Intercept Technology. Nonetheless,
in light of the fact that Intercept is in an early-stage development company, DSP is willing to bear [***] percent ([***]%) of
reasonable and actual costs and expenses incurred by DSP in connection with any defense of which DSP assumes control (the “DSP
Defense Costs”), with the remainder being reimbursed by Intercept in
the form of reduced royalties owed to it from DSP pursuant to Section 9.3, provided that in the event of an Intercept Change
of Control, DSP may reduce the percentage of DSP Defense Costs for which DSP is responsible. Notwithstanding anything to the contrary
herein, from the [***] ([***]) anniversary of the Effective Date, the preceding proviso shall become null and void, such that Intercept
shall be fully responsible for all actual and reasonable costs incurred by DSP in any defense which it assumes pursuant to this
Section 12.3. Irrespective of which Party is taking the lead with respect to the defense of a claim, the Party taking the lead
shall keep the other Party reasonably informed as to the status of any such action and shall give due regard to the comments and
suggestions of the other Party with respect to the defense of such claims. DSP shall have the right to participate in the defense
of any such claim with counsel of its choice at its own expense. Intercept shall not have the right to settle any claim or litigation
described in this Section 12.3 without the consent of DSP, such consent not to be unreasonably withheld; notwithstanding which,
in the event that DSP assumes control of the defense of any such claim in accordance with this Section 12.3, then DSP shall be
entitled to settle such matter in its reasonable discretion. If a Party brings any such action or proceeding hereunder, the other
Party agrees to be joined as party plaintiff if necessary to prosecute such action or proceeding, and to give the Party bringing
such action or proceeding reasonable assistance and authority to file and prosecute the suit; provided, however, that neither Party
shall be required to transfer any right, title or interest in or to any property to the other Party or any Third Party to confer
standing on a Party hereunder.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
31

    	 

    

 

12.4         Ownership
of Improvements. Intercept shall solely own all Improvements that are made, conceived or reduced to practice solely by
one or more employees or contractors of either Intercept arising in connection with the performance by Intercept of its obligations
hereunder. Intercept hereby grants to DSP the exclusive right to use all such Intercept Improvements in the Territory during the
Term of this Agreement. DSP shall solely own all Improvements that are made, conceived or reduced to practice solely by one or
more employees or contractors of DSP arising in connection with the performance by DSP of its obligations hereunder. DSP hereby
grants to Intercept the non-exclusive right to use all such DSP Improvements outside the Territory during the Term of this Agreement.
Each of DSP and Intercept shall have the right, in its discretion, but subject to the terms and conditions of this Agreement, to
file patents applications with respect to their respective Improvements.

 

12.5         Joint
Improvements.

 

12.5.1           Ownership
and Disclosure. DSP and Intercept shall be joint owners in and to any and all Joint Improvements and any Patents claiming
such Joint Improvements. Subject to the terms and conditions of this Agreement, DSP and Intercept, as joint owners of the Joint
Improvements, shall have the right to practice and exploit the Joint Improvements without any obligation to account to the other
for profits. Any assignment of an interest in a Joint Improvement shall require the prior consent of the other Party, such consent
not to be unreasonably withheld. Each Party agrees to be named as a party, if necessary, to bring or maintain a lawsuit involving
a Joint Improvement. Each Party shall promptly report to the other Party in writing, through the JSC, and shall cause its Affiliates,
licensees (including sublicensees), and contractors (including subcontractors) to so disclose, the invention or conception of any
Joint Improvements.

 

12.5.2           Prosecution
and Maintenance.

 

(i)   Inside the Territory,
DSP shall have the first right to prepare, file, prosecute and maintain Joint Improvements at its own cost and expense. Through
its progress reports submitted to the JSC pursuant to Section 3.5, DSP shall keep Intercept informed of the status of all filings
related to the Joint Improvements (including the nature of any objections and other information reasonably requested by Intercept)
and will provide Intercept with copies, in either English or Japanese, of all substantive documentation submitted to, or received
from, the patent offices in connection therewith. DSP shall provide Intercept with the right to comment on the documentation. The
Parties shall cooperate reasonably in the prosecution of all Patents covering the Joint Improvements if practicably possible and
shall share all material information relating thereto promptly after receipt
of such information. If during the Term of this Agreement, DSP
intends to allow any Patent claiming a Joint Improvement to expire or intends to otherwise abandon any such Patent in the Territory,
or decides not to file patent applications covering or claiming a Joint Invention in the Territory, DSP shall notify Intercept
of such intention or decision at least ninety (90) days prior to any filing or payment due date, or any other that requires action,
in connection with such Patent in the Territory, and Intercept shall thereupon have the right, but not the obligation to assume
responsibility for the preparation, filing, prosecution or maintenance thereof at its sole cost and expense, in the name of and
solely owned by Intercept.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
32

    	 

    

 

(ii)   Outside the Territory,
Intercept shall have the first right to prepare, file, prosecute and maintain Joint Improvement at its own cost and expense. Intercept
shall keep DSP informed of the status of all filings related to the Joint Improvement and will provide Intercept with copies, in
either Japanese or English, of all substantive documentation submitted to, or received from, the patent offices in connection therewith.
Intercept shall provide DSP with the right to comment on the documentation. The Parties shall cooperate reasonably in the prosecution
of all Patents covering the Joint Improvement if practicably possible and shall share all material information relating thereto
promptly after receipt of such information. If during the term of this Agreement, Intercept intends to allow any Patent claiming
a Joint Improvement to expire or intends to otherwise abandon any such Patent outside the Territory, or decides not to file patent
applications covering or claiming a Joint Invention in the Territory, Intercept shall notify DSP of such intention or decision
at least ninety (90) days prior to any filing or payment due date, or any other that requires action, in connection with such Patent
outside the Territory, and DSP shall thereupon have the right, but not the obligation to assume responsibility for the preparation,
filing, prosecution or maintenance thereof at its sole cost and expense, in the name of and solely owned by DSP.

 

12.5.3           Enforcement;
Defense. Through the JSC, the Parties shall develop a process to coordinate the defense of Patents claiming a Joint Improvement,
including cost-sharing allocation, both inside and outside the Territory; provided that should the Parties be unable to resolve
any disagreement regarding the defense of a Patent claiming a Joint Improvement, such issue shall be resolved in accordance with
Section 12.5.4.

 

12.5.4           Ownership
and Other Disputes. The JSC shall resolve any issues regarding inventorship or ownership of Joint Improvements and the
defense of any Patent claiming a Joint Improvement pursuant to the provisions of Article 12. In connection with the resolution
of this issue, each Party is entitled to have a patent lawyer of its own choosing attend the meeting and submit its written legal
opinion. In the event that the JSC is unable to reach a decision, the matter shall be referred for resolution to a patent counsel,
reasonably acceptable to both Parties, who is affiliated with a firm of international repute. The decision of such patent attorney
shall be rendered in writing and shall be final and binding on the parties. Each Party shall bear its own costs and expenses for
legal advice provided to it in accordance with the second sentence of this Section 12.5.3. All costs and expenses incurred in connection
with the mutually appointed patent attorney shall be shared equally.

 

12.6         Trademarks.
 DSP shall own and have sole control over all matters relating to the use of all trademarks (and all associated goodwill) used
in the sale of Products in the Field in the Territory.  DSP shall be solely responsible for trademark searches, prosecution
of applications to register and to record licenses (if applicable), and maintenance of the Product-related trademarks in the Territory
as well as costs and expenses incurred in connection with the foregoing. If Intercept becomes aware of any actual or threatened
infringement of any Product-related trademark by a Third Party, it shall promptly notify DSP, who shall be responsible for enforcing
the Product-related trademarks.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
33

    	 

    

 

13.         REPRESENTATIONS,
WARRANTIES AND COVENANTS

 

13.1         Intercept’s
Representations. Intercept represents and warrants to DSP that as of the Effective Date and throughout the Term of this
Agreement:

 

(a)          The
execution and delivery of this Agreement and the performance of the transactions contemplated hereby have been duly authorized
by all appropriate Intercept corporate action;

 

(b)          This
Agreement is a legal and valid obligation binding upon Intercept and enforceable in accordance with its terms, and the execution,
delivery and performance of this Agreement by the Parties, and does not conflict with any agreement, instrument or understanding
to which Intercept is a party or by which it is bound;

 

(c)          Intercept
has, to the best of its knowledge, the full right and legal capacity to grant the rights granted to DSP hereunder without violating
the rights of any Third Party, and is the sole and exclusive owner of the Intercept Technology and the Intercept Manufacturing
Technology, all of which are free and clear of any liens, charges and encumbrances.

 

(d)          To
Intercept’s best knowledge, there are no pending legal actions, nor is Intercept aware of the receipt of any written notice
regarding any pending legal actions or threatened claims (including pending re-examination, opposition or interference), with respect
to the Intercept Technology or the Intercept Manufacturing Technology, or litigation seeking to invalidate any Intercept Technology
or any Intercept Manufacturing Technology;

 

(e)          Intercept
owns the Intercept Patents listed on Exhibit A, has not assigned, transferred, conveyed or otherwise encumbered its right,
title and interest in the Intercept Patents, Intercept Know-How, or Intercept Manufacturing Technology in the Territory.

 

(f)          Intercept
has not granted, and during the Term of this Agreement will not grant, rights to any Third Party under the Intercept Technology
or the Intercept Manufacturing Technology that conflict with the rights granted to DSP hereunder.

 

(g)          Intercept
is not aware of any safety, efficacy, or regulatory issues, other than the information that has previously been made available
to DSP in writing that would preclude DSP from Developing, Manufacturing, or otherwise Commercializing the Products in the Field
in the Territory.

 

(h)          To
Intercept’s best knowledge, DSP’s exercise of its rights with respect to the Intercept Technology and the Intercept
Manufacturing Technology shall not infringe any patent or other
intellectual property right of any Third Party.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
34

    	 

    

 

(i)          All
material Development activities with respect to the Product whether clinical, non-clinical or preclinical conducted by Intercept
or at its request, has been, and shall be conducted in compliance with all applicable Law, including but not limited to Good Manufacturing
Practices, Good Clinical Practice and Good Laboratory Practices.

 

13.2         DSP
Representations. DSP represents and warrants to Intercept that as of the Effective Date:

 

(a)          the
execution and delivery of this Agreement and the performance of the transactions contemplated hereby have been duly authorized
by all appropriate DSP corporate action; and

 

(b)          this
Agreement is a legal and valid obligation binding upon DSP and enforceable in accordance with its terms, and the execution, delivery
and performance of this Agreement by the Parties does not conflict with any agreement, instrument or understanding to which DSP
is a party of or by which it is bound.

 

(c)          to
DSP’s knowledge, DSP’s exercise of its rights with respect to the Intercept Technology and the Intercept Manufacturing
Technology shall not infringe any patent or other intellectual property right of any Third Party.

 

13.3         Change
of Control Covenant. Intercept shall provide DSP with prior written notice of a proposed or contemplated Intercept Change
of Control and shall use Commercially Reasonable Efforts to afford DSP an opportunity to meet with the potential acquirers (or
the like) to discuss any necessary or advisable amendments to this Agreement no later than 60 days prior to the effective date
of the Intercept Change of Control.

 

13.4         Competitive
Products. DSP shall not engage, directly or indirectly, in the commercialization of any other product FXR agonist compound
or product in the Field within the Territory. For the avoidance of doubt, this does not include manufacturing, research or development
activities. Further, this provision shall not apply to any country in the Territory or any indication with respect to which the
nature of the rights granted to DSP under this Agreement are converted to non-exclusive rights by Intercept pursuant to Section
15.2(c) of this Agreement.

 

13.5         No
Warranties.

 

Nothing in this Agreement
is or shall be construed as:

 

(a)          a
warranty or representation by either Party as to the validity, enforceability,
or scope of any patent application or patent licensed hereunder or

 

(b)          a
warranty or representation that anything made, used, sold or otherwise disposed of under any license granted pursuant to this Agreement
is or will be free from infringement of patents, copyrights, and other rights of third parties.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
35

    	 

    

 

EXCEPT AS EXPRESSLY
SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED.
THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR OF NON-INFRINGEMENT OF ANY
PATENT, COPYRIGHT, TRADEMARK, OR OTHER RIGHTS OF THIRD PARTIES, OR ANY OTHER EXPRESS OR IMPLIED WARRANTIES.

 

14.         INDEMNIFICATION

 

14.1         Indemnification.

 

14.1.1           DSP
Indemnity. DSP shall indemnify, defend and hold harmless Intercept and its Affiliates and their respective directors, officers,
employees, stockholders and agents and their respective successors, heirs and assigns (the “Intercept Indemnitees”)
from and against any liability, damage, loss or expense (including reasonable attorneys’ fees and expenses of litigation)
incurred by or imposed upon such Intercept Indemnitees, or any of them, in connection with any Third Party claims, suits, actions,
demands or judgments, including, without limitation, personal injury and product liability matters, to the extent arising out of
(i) the Development, Manufacture, or Commercialization or use by any person of any the Product Manufactured or sold by DSP or any
Affiliate or sublicensee under this Agreement, (ii) any material breach of this Agreement by DSP, or (iii) the negligence or willful
misconduct on the part of DSP or any Affiliate or sublicensee, in any such case under this Section 14.1.1, except to the extent
of Intercept’s responsibility therefor under Section 14.1.2 below.

 

14.1.2           Intercept
Indemnity. Subject to Section 14.1.1 above, Intercept shall indemnify, defend and hold harmless DSP, its Affiliates and
their respective directors, officers, employees, and agents, and their respective successors, heirs and assigns (the “DSP
Indemnitees”), from and against any liability, damage, loss or expense (including reasonable attorneys’ fees and expenses
of litigation) incurred by or imposed upon such DSP Indemnitees, or any of them, in connection with any Third Party claims, suits,
actions, demands or judgments, including, without limitation, personal injury and product liability matters, to the extent arising
out of (i) the Manufacture of any the Product Manufactured or by or on behalf of Intercept, (ii) any actions or omissions of Intercept
or its Affiliates under this Agreement, (iii) any material breach of this Agreement by Intercept, or (iv) the negligence or willful
misconduct on the part of Intercept or any Affiliate, except to the extent of DSP’s responsibility therefore under Section
14.1.1 above.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
36

    	 

    

 

14.2         Indemnification
Procedures. In the event that any Indemnitee is seeking indemnification under Section 14.1 above from a Party (the “Indemnifying
Party”), the other Party shall notify the Indemnifying Party of such claim with respect to such Indemnitee as soon as reasonably
practicable after the Indemnitee receives notice of the claim, and the Party (on behalf of itself and such Indemnitee) 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) and shall cooperate as requested (at the expense of the Indemnifying Party) in the defense of the claim.
The indemnification obligations under Article 14 shall not apply to any harm suffered as a direct result of any delay in notice
to the Indemnifying Party hereunder or to amounts paid in settlement of any claim, demand, action or other proceeding if such settlement
is effected without the consent of the Indemnifying Party, which consent shall not be withheld or delayed unreasonably. The Indemnitee,
its employees and agents, shall reasonably cooperate with the Indemnifying Party and its legal representatives in the investigation
of any claim, demand, action or other proceeding covered by Section 14.1.

 

14.3         Limitation
on Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR LOSS, DAMAGE, OR LIABILITY WITH RESPECT TO LOSS OF PROFIT,
SPECIAL, INDIRECT, CONSEQUENTIAL, OR PUNITIVE DAMAGE. 

 

15.         TERM
AND TERMINATION

 

15.1         Term;
Expiration. The term of this Agreement (the “Term”) shall commence on the Effective Date and expire on a country-by-county
basis on the later to occur of (i) the tenth (10th) anniversary of the First Commercial Sale of the Product for the
first or second indication in such country (whichever is later) or (ii) the expiration date of the Exclusive Period in such country.
The Agreement as a whole shall expire on the date upon which the Agreement terminates with respect to the last country in the Territory.

 

15.2         Material
Breach. (a) In the case that one of the Parties believes that the other Party has materially breached the Agreement, the
JSC shall be notified and meet as soon as possible in order that the Parties attempt to resolve any dispute as to the existence
of any such material breach. Failing a consensus decision by the JSC
within thirty (30) days of receiving the matter for review,
it shall then be referred for “Executive Negotiation” as set forth in Article 16.1. Failing a decision by
the business executives within sixty (60) days of receiving the matter for review from
the JSC, the non-breaching Party
may then proceed to give written notice of termination for material breach.

 

(b)          If
pursuant to Section 15.2(a), either Party gives written notice to the other Party of termination for material breach, which notice
shall describe such material breach in reasonable detail and whether it has been deemed non-curable or curable by the JSC and senior
executives, this Agreement and the rights and options granted herein may be terminated by the non-breaching Party, effective ten
(10) days after giving written notice to the breaching Party of termination for non-curable breach, thirty (30) days after giving
written notice to the breaching Party of such termination in the case of a curable payment breach, and sixty (60) days after giving
written notice to the breaching Party of such termination in the case of any other curable breach. The foregoing notwithstanding,
if any curable material breach is cured within the aforesaid thirty (30) or sixty (60) day period, the notice shall be automatically
withdrawn and of no effect.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
37

    	 

    

 

(c)          Any
exercise by Intercept or DSP of its rights under Section 15.2(b) may be on a country-by-country or indication-by-indication basis,
at Intercept’s discretion, or DSP discretion, in which case such termination shall be partial in nature and shall only apply
to the particular country or indication which is the source of the alleged material breach.
Furthermore, Intercept shall have the alternative option, in its sole discretion, instead of terminating the Agreement in part
or in whole, to convert the exclusive appointment of DSP under Section 2 of this Agreement into a non-exclusive appointment, and
to apply such non-exclusive status on a country-by-country or indication-by-indication basis, at Intercept’s sole discretion,
in which case such non-exclusivity shall only apply to the particular country or indication which is the source of the alleged
material breach.

 

15.3         Voluntary
Termination. DSP shall have the right to terminate this Agreement at any time upon ninety (90) days’ written notice
to Intercept, either in its entirety or on a country-by-country basis or indication-by-indication basis, at the discretion of DSP.

 

15.4         Effects
of Termination.

 

15.4.1    Upon
the expiration of this Agreement or any termination of the entire Agreement by DSP under Section 15.2, as of the effective date
of such expiration or termination, DSP thereafter automatically shall have a perpetual, fully sublicensable and transferable,
exclusive license in the Territory under the Intercept Technology and Intercept Manufacturing Technology, to Develop, have Developed,
make, have made (including Manufacture), use, have used, sell, have sold, offer for sale, import and have imported or otherwise
Commercialize any and all Products and to practice the Intercept Technology and the Manufacturing Technology in the Territory.
Such license shall not be fully paid-up, but instead shall be payable as follows (subject to Intercept making the transfer of
the relevant Manufacturing Technology to DSP):

 

(a)          if
before the First Commercial Sale, then [***] percent ([***]%) of royalties that would have become due under Section 9 of this Agreement
but for the termination or expiration, for a period equal to the remainder of the Term of the Agreement, had the Agreement not
been terminated;

 

(b)          if
after the First Commercial Sale, then [***] percent ([***]%) of royalties that would have become due under Section 9 of this Agreement
but for the termination or expiration, for a period equal to the remainder of the Term of the Agreement, had the Agreement not
been terminated; provided, however, that in the event Intercept does not comply with its obligations under the Commercial Supply
Agreement, the applicable rate will be [***] percent ([***]%).

 

(c)          At
the end of the period equal to the remainder of the Term of the Agreement, had the Agreement not been terminated, the exclusive
license shall be deemed fully paid-up. Intercept shall disclose to DSP all material research, non-clinical and clinical data on
Products generated prior to the termination date outside the Territory and DSP shall thereafter have the unrestricted right to
use such data and information in the Territory. Intercept shall promptly provide to DSP any other material, information, contracts,
etc. which Intercept owns or Controls related to the Intercept Product in the Territory and are reasonably required to allow DSP
to continue the Development, Manufacture and Commercialization of Products in the Territory with minimal delay.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
38

    	 

    

 

(d)          The
foregoing notwithstanding, in the case that DSP determines, in its sole discretion, upon termination of the Agreement pursuant
to this Section 15.4.1 to cease all Development, Manufacturing and Commercialization activities relating to the Compound and the
Product, then all licenses and sublicenses shall revert in full to Intercept and DSP shall have no further payment obligations
to Intercept. To give effect to the reversion of the licenses and sublicenses, DSP shall be bound by its obligations pursuant to
Section 15.4.2 below, except that DSP shall not be bound to disclose to Intercept all material research, non-clinical and clinical
data (except for safety data) on Products generated prior to the termination date, nor shall DSP be bound to assign all Regulatory
Filings relating to Products in the Territory.

 

15.4.2       Upon
any termination of the Agreement by Intercept under Section 15.2 , or upon any termination of the Agreement by DSP under Section
15.3, as of the effective date of such termination all relevant licenses and sublicenses granted by Intercept to DSP shall cease
and all such licenses and sublicenses shall revert in full to Intercept. If there is a partial termination, only the licenses
and sublicenses as to the respective country and/or indication being terminated shall revert to Intercept. In order to revert
the licenses and sublicenses, DSP shall be obligated to the following:

 

(a)          DSP
shall provide to Intercept (or at Intercept’s request, destroy) all remaining Product and disclose to Intercept all material
research, non-clinical and clinical data on Products generated prior to the termination date and Intercept shall thereafter have
the unrestricted right to use such data and information;

 

(b)          DSP
shall assign to Intercept all Regulatory Filings relating to Products in the Territory, if assignment is permitted by applicable
Regulatory Authorities; and

 

(c)          DSP
shall promptly provide to Intercept any other material, reagents, information, contracts, etc. DSP owns or Controls related to
the Intercept Product and are reasonably required to allow Intercept to continue the research, Development, protection, and Commercialization
of Products with minimal delay.

 

15.4.3      Remedies.
Except as otherwise expressly set forth in this Agreement, the termination provisions of this Section 15 are in addition to any
other relief and remedies available to either Party at law.

 

15.4.4      Joint
Improvements. For the avoidance of doubt, Joint Improvements shall remain jointly owned upon any termination or expiration
of the agreement.

 

15.4.5      Surviving
Provisions. Notwithstanding any provision herein to the contrary, the rights and obligations of the Parties set forth
in Sections 10.3, 11.1, 12, 14, and 15.4 shall survive the date of termination or expiration of the Agreement (except as otherwise
provided for in this Agreement). Without limiting the generality of the foregoing, DSP shall have no obligation to make any milestone
or royalty payment to Intercept that has not accrued prior to the effective date of any termination or expiration of this Agreement
(except with respect to the payments pursuant to Section 15.4.1), but shall remain liable for all such payment obligations accruing
prior to the effective date of such termination.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
39

    	 

    

 

16.         DISPUTES

 

16.1         Executive
Negotiation. The Parties recognize that a bona fide dispute as to certain matters may from time to time arise during the
Term of this Agreement that relates to either Party’s rights and/or obligations hereunder. In the event of the occurrence
of such a dispute, either Party may, by written notice to the other Party, have such dispute referred to their respective senior
officials designated below or their successors, for attempted resolution by good faith negotiations within sixty (60) days after
such notice is received. Said designated senior officials are as follows:

 

For Intercept: Chief
Executive Officer

 

For DSP: Chief Executive
Officer (or a designated senior executive with decision-making authority).

 

In the event the designated
senior officials are not able to resolve such dispute within the sixty (60) day period, either Party may invoke the provisions
of Section 16.2.

 

16.2         Arbitration.
Subject to Section 16.1 and except with respect to disputes relating to the intellectual property or a breach of the confidentiality
obligations of this Agreement, any dispute, controversy or claim initiated by either Party arising out of, resulting from or relating
to this Agreement, or the performance by either Party of its obligations under this Agreement (other than bona fide Third Party
actions or proceedings filed or instituted in an action or proceeding by a Third Party against a Party), whether before or after
termination of this Agreement, shall be submitted to the International Court of Arbitration of the International Chamber of Commerce
and shall be finally settled by binding arbitration. Whenever a Party shall decide to institute arbitration proceedings, it shall
give written notice to that effect to the other Party. Any such arbitration shall be conducted under the then-current Rules of
Arbitration of the International Chamber of Commerce Rules of Arbitration by a panel of one or more arbitrators appointed in accordance
with such rules. Any such arbitration shall be held in New York, New York if initiated by DSP and in Osaka, Japan if initiated
by Intercept. All arbitration proceedings, communications, and documents shall be in the English language. Judgment upon the award
so rendered may be entered in any court having jurisdiction or application may be made to such court for judicial acceptance of
any award and an order of enforcement, as the case may be. Notwithstanding the foregoing, each Party may at any time pursue equitable
remedies, including without limitation injunctive relief, to protect its respective Confidential Information as well as its respective
intellectual property rights, including Know-How and Patents.  For the avoidance of doubt, either Party can take such action
without first having to go to the JSC pursuant to Section 3, or the Executive Negotiation pursuant to Section 16.1.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
40

    	 

    

 

17.         MISCELLANEOUS

 

17.1         Notification.
All notices, requests and other communications hereunder shall be in writing, shall be addressed to the receiving Party’s
address set forth below or to such other address as a Party may designate by notice hereunder, and shall be either (i) delivered
by hand, (ii) made by facsimile transmission (to be followed with written fax confirmation), (iii) sent by private courier service
providing evidence of receipt, or (iv) sent by registered or certified mail, return receipt requested, postage prepaid. The addresses
and other contact information for the parties are as follows:

 

	If to Intercept:	
        Intercept Pharmaceuticals, Inc.

        18 Desbrosses Street

        New York, NY 10013

        Fax: +1-646-747-1001

	 	 
	If to DSP:	
        Director of Business Development

        6-8, Doshomachi 2-Chome

        Chuo-ku, Osaka 541-0045, Japan

        Fax: +81-6-6203-4533

        

 

All notices, requests and other communications
hereunder shall be deemed to have been given either (i) if by hand, at the time of the delivery thereof to the receiving Party
at the address of such Party set forth above, (ii) if made by telecopy or facsimile transmission, at the time that receipt thereof
has been acknowledged by the recipient, (iii) if sent by private courier, on the day such notice is delivered to the recipient,
or (iv) if sent by registered or certified mail, on the fifth (5th ) business day following the day such mailing is
made.

 

17.2         Governing
Law. This Agreement will be construed, interpreted and applied in accordance with the laws of the state of New York (excluding
its conflict of law principles law).

 

17.3         Limitations.
Except as expressly set forth in this Agreement, neither Party grants to the other Party any right or license to any of its intellectual
property.

 

17.4         Entire
Agreement. This is the entire Agreement between the Parties with respect to the subject matter hereof and supersedes all
prior representations, understandings and agreements between the Parties with respect to the subject matter hereof. No modification
shall be effective unless in writing with specific reference to this Agreement and signed by the Parties.

 

17.5         Waiver.
The terms or conditions of this Agreement may be waived only by a written instrument executed by the Party waiving compliance.
The failure of either Party at any time or times to require performance of any provision hereof shall in no manner affect its rights
at a later time to enforce the same. No waiver by either Party of any condition or term shall be deemed as a continuing waiver
of such condition or term or of another condition or term.

 

17.6         Assignment.
Neither this Agreement nor any right or obligation hereunder may be assigned, delegated or otherwise transferred, in whole or part,
by either Party without the prior express written consent of the other Party, which may be withheld in the sole discretion of the
Party giving such consent.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
41

    	 

    

 

17.7         Force
Majeure. Neither Party shall be liable for failure of or delay in performing obligations set forth in this Agreement, and
neither shall be deemed in breach of its obligations, if such failure or delay is due to natural disasters or any cause beyond
the reasonable control of such Party. In event of such force majeure, the Party affected thereby shall use reasonable efforts to
cure or overcome the same and resume performance of its obligations hereunder.

 

17.8         Construction.
The Parties hereto acknowledge and agree that: (i) each Party and its counsel reviewed and negotiated the terms and provisions
of this Agreement and have contributed to its revision; (ii) the rule of construction to the effect that any ambiguities are resolved
against the drafting Party shall not be employed in the interpretation of this Agreement; and (iii) the terms and provisions of
this Agreement shall be construed fairly as to all Parties hereto and not in favor of or against any Party, regardless of which
Party was generally responsible for the preparation of this Agreement.

 

17.9         Severability.
If any provision(s) of this Agreement are or become invalid, are ruled illegal by any court of competent jurisdiction or are deemed
unenforceable under then current applicable law from time to time in effect during the Term hereof, it is the intention of the
Parties that the remainder of this Agreement shall not be affected thereby provided that a Party’s rights under this Agreement
are not materially affected. The Parties hereto covenant and agree to renegotiate any such term, covenant or application thereof
in good faith in order to provide a reasonably acceptable alternative to the term, covenant or condition of this Agreement or the
application thereof that is invalid, illegal or unenforceable, it being the intent of the Parties that the basic purposes of this
Agreement are to be effectuated.

 

17.10         Further
Assurances. Each Party agrees to execute, acknowledge and deliver such further instructions, and to do all such other acts,
as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement.

 

17.11         Affiliate
Delegation. DSP may delegate to an Affiliate all or part of its obligations hereunder, provided that it shall provide
prior notice to Intercept.

 

17.12         
Compliance with Law. Each Party shall comply with all applicable Laws, including by way of example, but without limitation
U.S. export controls and the U.S. Foreign Corrupt Practices Act.

 

17.13         Governing
Language. This Agreement has been executed in English. If any translation of this Agreement conflicts with the English
version or contains terms in addition to or different from the English version, the English version shall prevail.

 

17.14         Counterparts.
This Agreement may be executed simultaneously in one or more counterparts, each of which shall be deemed an original, but all of
which together shall constitute one and the same instrument.

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
42

    	 

    

 

[SIGNATURES FOLLOW ON THE NEXT PAGE.]

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
43

    	 

    

 

IN WITNESS WHEREOF,
the Parties have caused this Agreement to be executed by their duly authorized representative in two (2) originals.

 

	DAINIPPON SUMITOMO PHARMA CO., LTD.	 	INTERCEPT PHARMACEUTICALS, INC.
	 	 	 
	/s/ Masayo Tada	 	/s/ Mark Pruzanski
	 	 	 
	Name:	Masayo Tada	 	Name:	Mark Pruzanski
	 	 	 
	Title:	President and Chief Executive Officer	 	Title:	President and Chief Executive Officer

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
44

    	 

    

 

EXHIBIT A

 

INTERCEPT PATENTS

 

	Country	 	Title	 	Serial No.	 	Filing
 Date	 	Parent PCT	 	Status	 	Patent
 No.
	Japan	 	Steroids As Agonists For FXR	 	2002-571512	 	Feb. 21, 2002	 	
        PCT/EP2002/001832

        WO2002/072598
	 	Granted	 	4021327
	 	 	 	 	 	 	 	 	 	 	 	 	 
	Japan	 	Process For Preparing 3alpha(Beta)-7alpha(Beta)-Dihydroxy-6alpha(Beta)-Alkyl-5beta Cholanic Acid	 	2008-511719	 	May 19, 2006	 	
        PCT/EP2006/062446

        WO2006/122977
	 	Pending	 	N/A
	 	 	 	 	 	 	 	 	 	 	 	 	 
	China	 	Process For Preparing 3alpha(Beta)-7alpha(Beta)-Dihydroxy-6alpha(Beta)-Alkyl-5beta Cholanic Acid	 	200680017025.6	 	May 19, 2006	 	
        PCT/EP2006/062446

        WO2006/122977
	 	Pending	 	N/A
	 	 	 	 	 	 	 	 	 	 	 	 	 
	Japan	 	Treatment Of Fibrosis Using FXR Ligands	 	2007-503111	 	Mar. 14, 2005	 	
        PCT/US2005/008575

        WO2005/089316
	 	Pending	 	N/A

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
45

    	 

    

 

EXHIBIT B

 

Summary of Sublicense Agreements

 

1. Sublicense Agreement

 

(a) Full corporate name of sublicensee:

 

(b) Applicable country:

 

(c) Applicable indications in the Field:

 

(d) Standard of sublicensee’s performance
(e.g. best efforts, commercially reasonable efforts, etc.):

 

(e) Term of sublicense agreement:

 

(f) Summary of termination provision:

 

2. Sublicensee Confirmation

 

I, [Name], the [Title] of [Full Corporate
Name of Sublicensee] (the “XX”) confirm and acknowledge that the XX is aware of and agrees to comply with the provisions
of that certain License Agreement, dated March 29, 2011 by and between Dainippon Sumitomo Pharma Co., Ltd. and Intercept Pharmaceuticals,
Inc. (the “Agreement”), which in accordance with their respective terms, are expressly applicable to XX, as a sublicensee
appointed pursuant to Section 2.1.2 of the Agreement.

 

By:

 

Name:

 

Title:

 

Date:

 

    	Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.
 
46Exhibit 10.11.1

   

PRODUCT RESEARCH, DEVELOPMENT, LICENSE

AND COMMERCIALIZATION AGREEMENT

 

by and between

 

LES LABORATOIRES SERVIER

 

and

 

INSTITUT DE RECHERCHES SERVIER

 

on the one hand

 

AND

 

INTERCEPT PHARMACEUTICALS, INC.

 

on the other hand

 

Effective Date: August 1st,
2011

 

    	page 1 of 67
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PRODUCT RESEARCH, DEVELOPMENT, 

LICENSE AND COMMERCIALIZATION AGREEMENT

 

This Product Research,
Development, License and Commercialization Agreement (this “Agreement”) is effective as of August 1st,
2011 (the “Effective Date”) and is entered into by and between INTERCEPT PHARMACEUTICALS, INC., a corporation
organized and existing under the laws of Delaware, with registered office at 18 Desbrosses Street, New-York 10013 NY, USA (“INTERCEPT”)
on the one hand and LES LABORATOIRES SERVIER, a corporation organized and existing under the laws of France, with registered office
at 22 rue Garnier, 92578 Neuilly-sur-Seine cedex, France and INSTITUT DE RECHERCHES SERVIER, a corporation organized and existing
under the laws of France, with registered office at 3 rue de la République, 92150 Suresnes, France (these two entities are
jointly referred to as “SERVIER”) on the other hand.

 

RECITALS

 

WHEREAS, INTERCEPT
has developed or otherwise Controls (as hereinafter defined) certain capabilities for the identification and validation of compounds
which are selective or non-selective TGR5 receptor agonists, as well as the development of pharmaceutical products for the treatment
of human diseases;

 

WHEREAS, SERVIER
discovers, develops, manufactures and markets pharmaceutical products for the treatment of human diseases and/or conditions;

 

WHEREAS, INTERCEPT
and SERVIER desire to engage in a collaborative effort, pursuant to which INTERCEPT
will engage in research program to discover Compounds in the Field (“Compounds” and “Field” as defined
below) and both SERVIER and INTERCEPT shall be entitled to complete the development
and commercialization of such Compounds pursuant to this Agreement;

 

NOW, THEREFORE,
in consideration of the foregoing premises and the mutual covenants herein contained, and for other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, SERVIER and INTERCEPT hereby agree as follows:

 

Article
1: DEFINITIONS

 

Unless specifically set forth to the contrary herein, the following
terms, whether used in the singular or plural, shall have the respective meanings set forth below.

 

		1.1	“Adverse Experience”
means any side effect, injury, toxicity or sensitivity reaction, or any unexpected incident, whether or not determined to be attributable
to any Product.

 

    	page 2 of 67
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		1.2	“Affiliate” means (1)
any corporation or business entity of which fifty percent (50%) or more of the securities or other ownership interests representing
the equity, the voting stock or general partnership interest are owned, controlled or held, directly or indirectly, by SERVIER
or INTERCEPT; or (2) any corporation or business entity which, directly or indirectly, owns, controls or holds fifty percent (50%)
(or the maximum ownership interest permitted by law) or more of the securities or other ownership interests representing the equity,
the voting stock or, if applicable, the general partnership interest, of SERVIER or INTERCEPT; or (3) any corporation or business
entity of which fifty percent (50%) or more of the securities or other ownership interests representing the equity, the voting
stock or general partnership interest are owned, controlled or held, directly or indirectly, by a corporation or business entity
described in (1) or (2). 

 

		1.3	“Agreement” means this
agreement, including all exhibits attached hereto.

 

		1.4	“Approval Application”
means any application necessary and appropriate to obtain a Regulatory Approval, together with all
required documents, data and information concerning any Product which is the subject of such application.

 

		1.5	“Calendar Quarter”
means each period of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.

 

		1.6	“Calendar Year” means
each period of twelve (12) consecutive calendar months commencing on January 1 and ending on December 31.

 

		1.7	“Clinical Development Plan”
means the JSC-reviewed written clinical development plan for a particular Product, setting forth the clinical development activities
to be conducted by the Parties with the goal of achieving Marketing Authorizations in both the EU and the United States of America.
Clinical Development Plans reviewed by the JSC pursuant to this Agreement shall be attached to and made a part of this Agreement
and may be amended from time to time. 

 

		1.8	“Clinical Trial” means
a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, as applicable. 

 

		1.9	“CMC” means “Chemistry,
Manufacturing and Controls”, development to be done until the Approval Application.

 

		1.10	“CMC Costs” means
all costs incurred by or on behalf of either Party that are reasonably and directly allocable to the conduct of the CMC activities
described in the Manufacturing Plan including costs of producing the Compound or Product used in non clinical studies and in Clinical
Trials for the Clinical Development Plan (i.e. excluding Product used in Clinical Trial for Territory Specific Work or for Unsponsored
Work). CMC Costs shall include internal costs and reasonable out-of-pocket costs actually incurred by each Party. For clarity,
equipment and facility depreciation and other allocations of fixed assets in use to support the development of Products are considered
reasonably allocable costs and not corporate overhead to the extent and for so long as such equipment, facility and fixed assets
are directly used for the development of the Products and set forth in the Manufacturing Plan.

 

		1.11	“Combination Product”
means a Product that includes one or more active ingredients other than Compound in combination with Compound. All references to
Product in this Agreement shall be deemed to include Combination Product.

 

    	page 3 of 67
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		1.12	“Commercially Reasonable Efforts”
means, with respect to the efforts to be expended by a Party with respect to any objective, the reasonable, diligent, good faith
efforts to accomplish such objective as such Party would normally use to accomplish a similar objective under similar circumstances.
It is understood and agreed that with respect to the research, development and sale of Compound and/or Product by either Party,
such efforts shall be substantially equivalent to those efforts and resources commonly used by such Party for pharmaceutical products
owned by it or to which it has rights, which product is at a similar stage in its development or product life and is of similar
market potential taking into account efficacy, safety, approved labelling, the competitiveness of alternative products in the marketplace,
the patent and other proprietary position of the Product, the likelihood of regulatory approval given the Regulatory Authority
involved, the profitability of the Product including the amounts payable to licensors of patent or other intellectual property
rights, alternative products and other relevant factors. Commercially Reasonable Efforts shall be determined on an Indication-by-Indication
basis for a particular Product. 

 

		1.13	“Committees”, “JEC”,
“JSC” and “JRDC” have the meaning set forth in Section 2.3.

 

		1.14	“Compound(s)” means
any chemical entity and/or active ingredient which (i) is a selective or non-selective TGR5 receptor agonist and (ii) is Controlled
by INTERCEPT or its Affiliates, or [***], synthesized by INTERCEPT
or its Affiliates pursuant to work conducted under the Research Program. 

 

		1.15	“Control,” “Controls,”
or “Controlled by” means, with respect to any item of or right under INTERCEPT Patent Rights, INTERCEPT
Know-How, SERVIER Patent Rights or SERVIER Know-How, the possession of (whether by ownership or license, other than pursuant to
this Agreement) or the ability of a Party to grant access to, or a license or sublicense of, such items or right as provided for
herein without violating the terms of any agreement or other arrangement with any Third Party existing at the time such Party would
be required hereunder to grant the other Party such access or license or sublicense.

 

		1.16	“Cost of Goods” shall
mean (i) to the extent manufactured by a contract manufacturing organization, the cost invoiced by such contract manufacturing
organization to manufacture Compound or Product (into final packaged form), as applicable, or (ii) to the extent manufactured by
INTERCEPT and/or SERVIER or their Affiliates, the cost directly related to the manufacturing of the Compound, bulk drug for a Product
or Product (into final packaged form), calculated in accordance with IFRS, as applicable, including all direct costs of raw materials,
packaging materials and labour utilized in such manufacturing (including formulating, filling, finishing, labelling and packaging,
as applicable). Cost of Goods shall not include any (a) margin or mark-up for profit for inter-company supply between a Party and
its own Affiliates (or among such Affiliates) and (b) costs associated with investigations and re-work of out-of-specification
material. Notwithstanding anything herein to the contrary, the Cost of Goods as determined under the circumstances set forth in
“(ii)” above shall not exceed the price a contract manufacturing organization as described in “(i)” above
would propose for the manufacturing in France (including formulating, filling, finishing, labelling and packaging, as applicable)
of the same Compound, bulk drug for a Product or Product, if such Compound, bulk drug for a Product or Product were procured on
comparable terms (during the same period of time, in similar quantities and packaging). For clarity, the comparison with the price
a contract manufacturing organization would propose shall only apply if and to the extent such a comparison is requested by the
non-manufacturing Party and shall not lead to either Party disclosing to such contract manufacturing organization any confidential
information or Know-How.

 

    	page 4 of 67
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		1.17	“Data” means all non-clinical
data, clinical data (including single patient clinical report forms (CRFs)), CMC data, clinical pharmacology data, research data
and manufacturing data (including stability data, chemical data and quality control data) pertaining to any Compound or Product,
which are Controlled by either Party at any time during the Term of this Agreement.

 

		1.18	“Derivative” shall
mean any chemical entity, the chemical structure of which was derived on the basis of structure-activity relationship (“SAR”)
data obtained with a Compound or series of Compounds.

 

		1.19	“Development Costs”
shall mean actual, direct costs and expenses incurred by SERVIER and its Affiliates or INTERCEPT and its Affiliates, as the case
may be, after the Effective Date in connection with the following: (i) conducting preclinical and clinical development activities
in performance of the Pre-Clinical Development Plan and of the Clinical Development Plan (or Unsponsored Work as the context requires),
including Clinical Trials direct costs including but not limited to: ethics committees fees, investigators fees, investigators
meetings costs, clinical research organization's services (limited to the following activities: monitoring, central and core laboratory
services, medical writing, data management, statistics analysis, bioanalysis and PK interpretation), personnel costs charged at
an allocated full time equivalent rate for time worked on each study (such cost to be converted into Euros and to be comprised
of standard staff costs and operating costs) (other costs such as overhead costs not directly related to the study are excluded);
(ii) Cost of Goods associated with the activities set forth in the foregoing clause “(i)” and; (iii) such other costs
as are expressly approved in writing by the Joint Research and Development Committee as “Development Costs". The “Development
Costs” shall include CMC Costs and shall exclude Territory Specific Work.

 

		1.20	“Effective Date”
means the date on which this Agreement is entered into by and between INTERCEPT and SERVIER. 

 

		1.21	“EMA” means the European
Medicines Agency. 

 

		1.22	“EU” means all countries
that are member states of the European Union at any given time during the term of this Agreement.

 

		1.23	“Euros” means the official
currency of the European Union.

 

		1.24	“FDA” means the United
States Food and Drug Administration or any successor governmental authority having substantially the same function.

 

“Field”
means any human use of a Product for the following Indications: Type 2 diabetes, complications of diabetes, obesity, atherosclerosis,
and reperfusion injury.

 

		1.25	“First Commercial Sale”
means [***]. 

 

		1.26	“Generic Competitor” means,
with respect to any Product in a country, a product containing the same active ingredient as the Product, and which Marketing Authorization
and commercial sale of such product in such country is by an entity other than SERVIER or its Related Parties. 

 

    	page 5 of 67
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		1.27	“Good Manufacturing Practice”
or “GMP” means the rules and Guidelines for Good Manufacturing Practice as defined under (i) 21 CFR part 210
and 211, (ii) Directive 2003/94/EC and (iii) and Volume 4, Rules Governing Medicinal Products in the EU, Part I and II, in each
case, as amended from time to time, and in conformity with equivalent regulations in other countries of SERVIER
Territory.

 

		1.28	“ICC” means the International
Chamber of Commerce.

 

		1.29	“Improvements” shall
mean and include [***].

 

		1.30	“IND” means 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.

 

		1.31	“Indication” means
a separate and distinct disease or medical condition in humans which a Compound/Product that is in Clinical Trials is intended
to treat, palliate and/or prevent and/or for which a Product has received Marketing Authorization.

 

		1.32	“Information” means
any and all information and data, including without limitation all SERVIER Know-How, all INTERCEPT Know-How, and all other scientific,
non clinical, clinical, regulatory, manufacturing, marketing, financial and commercial information or data, whether communicated
in writing or orally or by any other method, which is provided by one Party to the other Party in connection with this Agreement.

 

		1.33	“Initiates,” “Initiated”
or “Initiation” means, with respect to a Clinical Trial, the administration of the first dose to the first patient
in such Clinical Trial.

 

		1.34	“INTERCEPT”
shall have the meaning given to such term in the preamble to this Agreement.

 

		1.35	“INTERCEPT
Change of Control” means: (a) the sale of all or substantially all of INTERCEPT’
assets or business relating to this Agreement; or (b) the acquisition by a person or entity, or group of persons or entities
acting in concert, of more than fifty percent (50%) of the voting equity securities of INTERCEPT
or of any of the entities directly or indirectly controlling INTERCEPT.

 

		1.36	“INTERCEPT
Indemnitee” refers to INTERCEPT, its Affiliates, its sublicensees and
their respective agents, employees, officers and directors, each to be indemnified by SERVIER.

 

		1.37	“INTERCEPT Invention(s)”
means any Invention (other than Joint Inventions) that is conceived by INTERCEPT solely.

 

		1.38	“INTERCEPT
Know-How” means any Know-How (other than Joint Know-How) which as of the Effective Date or during the Term is or become
Controlled by INTERCEPT or its Affiliates.

 

		1.39	“INTERCEPT
Patent Rights” means any Patent Rights (other than INTERCEPT’s rights in Joint Patent Rights) which, as of the
Effective Date or during the Term, are or become Controlled by INTERCEPT or its
Affiliates and which are necessary or useful to develop, manufacture, have manufactured, use, have used, sell, have sold, import
and export the Compound and/or the Product. For clarity, INTERCEPT Patent Rights include patents claiming compounds INT-1212 and
INT-1244.

 

    	page 6 of 67
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		1.40	“INTERCEPT
Technology” means INTERCEPT Know-How, INTERCEPT Patent Rights and INTERCEPT’s rights in Joint Patent Rights
and in Joint Know-How.

 

		1.41	“INTERCEPT
Territory” means the United States of America and their possessions and territories and Japan.

 

		1.42	“Invention(s)” means
any process, method, composition of matter, article of manufacture, discovery or finding, patentable or not patentable, that is
conceived and reduced to practice by a Party solely or jointly by the Parties or their Affiliates or consultants, in connection
with activities performed under this Agreement, including, without limitation, any improvements thereof.

 

		1.43	“Joint Invention(s)”
means any Invention which is generated under the Research Program irrespective of whether such Invention is jointly made or made
solely by either of INTERCEPT or its Affiliates or SERVIER or its Affiliates or their respective consultants. 

 

		1.44	“Joint Know-How” means
all Know-How generated under the Research Program irrespective of whether such Know-How is jointly generated or generated solely
by either of INTERCEPT or its Affiliates or SERVIER or its Affiliates or their respective consultants. 

 

		1.45	“Joint Patent Rights”
mean Patent Rights that claim or cover Joint Inventions.

 

		1.46	“Know-How” means all
information and materials, including, but not limited to, discoveries, improvements, processes, methods, protocols, formulas, data,
inventions (including Inventions but excluding those Inventions covered under INTERCEPT Patent Rights and/or SERVIER Patent Rights),
know-how and trade secrets, patentable or otherwise, which as of the Effective Date or during the Term: (i) are or become Controlled
by a Party or its Affiliates, (ii) are not generally known, and (iii) are necessary or useful to develop, manufacture, market,
use or sale the Compound and/or the Product.

 

		1.47	“Manufacturing Plan”
shall have the meaning given to such term in Section 2.5.

 

		1.48	“Marketing Authorization”
or “Regulatory Approval” means all approvals from the relevant Regulatory Authority necessary to market and
sell a Product in any country.

 

		1.49	“Material Impact” means,
with respect to a Party, a material adverse impact on the Product in such Party’s applicable territory.

 

		1.50	“Net Sales” Except
as provided below with respect to clinical trial samples, in the case of sales by or for the benefit of SERVIER, its Affiliates,
and its sublicensees (the “Seller”) to independent, unrelated persons (“Buyers”) in bona fide arm’s
length transactions, “Net Sales” means the gross amount billed or invoiced by Seller with respect to the Product, less
the following deductions, in each case to the extent actually allowed and taken by such Buyers and not otherwise recovered by or
reimbursed to Seller in connection with such  Product (“Permitted Deductions”): [***]. “Net Sales”
shall not include any consideration received with respect to a sale, use or other disposition of any Product in a country as part
of a clinical trial necessary to obtain Regulatory Approval in such country. All of the foregoing elements of Net Sales calculations
shall be determined in accordance with IFRS or successor standards and guidelines thereto. In the case of transfers of Product
between any of SERVIER, its sublicensees, and affiliates of any of the foregoing, for subsequent sale, rental, lease or other
transfer of such Products to third parties, Net Sales shall be the gross invoice or contract price charged to the third party
customer for that Product, less the deductions set forth in clauses [***] above. In the event that a Product consists of a combination
of the Compound with one or more other active agents, Net Sales, for the purpose of determining royalty payments, shall be [***].
In the case of any sale or other disposal other than in an arm’s length transaction exclusively for cash, such as barter
or counter-trade, of any Product, or part thereof, Net Sales shall be [***]. Finally, [***], shall be included in the calculation
of Net Sales.

 

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		1.51	“Party” means SERVIER
or INTERCEPT, individually, and “Parties” means SERVIER and INTERCEPT, collectively.

 

		1.52	“Patent Rights” means
any and all patents and patent applications (which for the purpose of this Agreement shall be deemed to include certificates of
invention and applications for certificates of invention), including divisionals, continuations, continuations-in-part, reissues,
renewals, substitutions, registrations, re-examinations, revalidations, extensions, supplementary protection certificates, and
the like, of any such patents and patent applications, and foreign equivalents of the foregoing, and any other patents and patent
applications claiming priority back to any of the foregoing.

 

		1.53	“Phase I Clinical Trial”
means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(a) or a similar clinical trial
as defined by the Regulatory Authorities.

 

		1.54	“Phase II Clinical Trial”
means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(b) or a similar clinical trial
as defined by the Regulatory Authorities.

 

		1.55	“Phase IIa Clinical Trial”
means a Phase II Clinical Trial of a Product, the principal purpose of which is a preliminary determination of efficacy and safety
in the target patient population over a range of doses.

 

		1.56	“Phase IIb Clinical Trial”
means a Phase II Clinical Trial of a Product, the principal purpose of which is a further determination of efficacy and safety,
in the target patient population, at the intended clinical dose or doses or range of doses, on a sufficient number of patients
and for a sufficient period of time to confirm the optimal manner of use of the Product (dose and dose regimen) prior to the initiation
of pivotal Phase III Clinical Trial(s).

 

		1.57	“Phase III Clinical Trial”
means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(c) or a similar clinical trial
as defined by the Regulatory Authorities.

 

		1.58	“Pre-Clinical Development Plan”
means the JSC-reviewed written pre-clinical development plan for a particular Product, setting forth the pre-clinical development
activities to be conducted by SERVIER or its Affiliates. Pre-Clinical Development Plans reviewed by the JSC pursuant to this Agreement
shall be attached to and made a part of this Agreement and may be amended from time to time. 

 

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		1.59	“Product” means any
pharmaceutical preparation containing the Compound, as an active ingredient, either alone or in combination with one or more other
active ingredient(s), (i) for sale by prescription, over-the-counter or any other method; or (ii) for administration to human patients
in a Clinical Trial. 

 

		1.60	“Regulatory Approval”
or “Marketing Authorization” means all approvals from the relevant Regulatory Authority necessary to market
and sell a Product in any country.

 

		1.61	“Regulatory Authority”
means any applicable government regulatory authority involved in granting approvals for the manufacturing and/or marketing of a
Product in the world, including EMA in the EU.

 

		1.62	“Related Party” means
each of SERVIER, its Affiliates, and their respective sublicensees (which term does not include distributors), as applicable. 

 

		1.63	“Research Program”
means the written research plan attached as exhibit A to this Agreement, setting forth the research activities to be conducted
by INTERCEPT and the budget. 

 

		1.64	“Research Program Term”
has the meaning given to such term in Section 2.1.1.

 

		1.65	“Selected Preclinical Compound”
has the meaning given to such term in Section 2.2.1.

 

		1.66	“SERVIER” shall have
the meaning given to such term in the preamble to this Agreement.

 

		1.67	“SERVIER Indemnitee”
refers to SERVIER, its Affiliates, Related Parties and their respective agents, employees, officers and directors, each to be indemnified
by INTERCEPT.

 

		1.68	“SERVIER Invention(s)”
means any Invention (other than Joint Inventions) that is conceived by SERVIER solely.

 

		1.69	“SERVIER Know-How”
means any Know-How (other than Joint Know-How) which as of the Effective Date or during the Term is or become Controlled by SERVIER
or its Affiliates.

 

		1.70	“SERVIER Patent Rights”
means any Patent Rights (other than SERVIER’s rights in Joint Patent Rights) which, as of the Effective Date or during the
Term, are or become Controlled by SERVIER or its Affiliates and which are necessary
or useful to develop, manufacture, have manufactured, use, have used, sell, have sold, import and export the Compound and/or the
Product.

 

		1.71	“SERVIER
Technology” means SERVIER Know-How, SERVIER Patent Rights and SERVIER’s rights in Joint Patent Rights and in
Joint Know-How.

 

		1.72	“SERVIER Territory”
means worldwide except (i) the United States of America and their possessions and territories and (ii) Japan.

 

		1.73	“Term” means the term
of this Agreement as defined in Section 9.1 of this Agreement.

 

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		1.74	“Territory-Specific Work”
means any Clinical Trial or non-clinical study performed by a Party that is required only by Regulatory Authorities in that Party’s
territory and not by the Regulatory Authorities in the other Party’s territory.

 

		1.75	“Third Party” means
an entity other than SERVIER and its Related Parties, and INTERCEPT and its Affiliates. 

 

		1.76	“Third Party Patent Licenses”
refers to patent licenses required by SERVIER or its Related Parties, from Third Parties in order to research, develop, use, import,
export, offer for sale or sell Compound or Product.

 

		1.77	“Unsponsored Work” has
the meaning set forth in Section  2.2.2(e)

 

		1.78	“Valid Patent Claim”
means (a) any claim of an issued and unexpired patent included within the INTERCEPT Patent Rights, SERVIER Patent Rights or Joint
Patent Rights which claims Compound or Product as a composition of matter or any use thereof or method of synthesis, or formulation,
which has not been permanently 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 abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or
disclaimer or otherwise or (b) any claim of a pending patent application included within the INTERCEPT Patent Rights, SERVIER Patent
Rights or Joint Patent Rights which claims Compound or Product as a composition of matter or any approved use thereof, which has
not been abandoned or finally disallowed without the possibility of appeal or re-filing of the application.

 

Article
2: SCOPE AND MANAGEMENT OF THE COLLABORATION

 

		2.1	Research
                                                           activities

 

Conduct

 

INTERCEPT shall conduct research
activities (such activities to include but not be limited to synthetic, computational and analytical chemistry) to discover, identify,
optimize and/or develop Compounds/Products up to the stage where they fulfil the criteria for a Selected Preclinical Compound.
The research activities to be undertaken by INTERCEPT and the various criteria to move from one stage to the other are set forth
in the Research Program. The Research Program shall be for an initial period of one year starting upon the Effective Date with
a potential extension by way of an amendment to the Agreement of one or several additional year(s) (hereinafter the “Research
Program Term”).

 

INTERCEPT will make such contributions
in terms of manpower deployment, equipment, facilities, and other contributions as specified in the Research Program. In terms
of manpower, it is intended that INTERCEPT will allocate for the performance of the research activities: up to [***] full time
equivalent (“FTE”) [***], [***] FTE [***] and [***] FTE [***]. SERVIER will contribute to the financing of the research
activities by reimbursing to INTERCEPT at an agreed initial annual rate of EUR [***] per FTE, up to a maximum amount of [***] euros
(EUR [***]) per year, provided such costs are duly justified and are in accordance with the budget contained in the Research Program.
Such reimbursement will be on a quarterly basis.

 

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INTERCEPT shall exercise Commercially
Reasonable Efforts in the performance of the research activities in accordance with the agreed scope of works and timelines specified
in the Research Program.

 

Subcontracting

 

INTERCEPT
may perform any of its research activities under this Agreement through one or more subcontractors and consultants upon written
notice to SERVIER, provided that (a) INTERCEPT remains responsible for the work allocated to, and payment to, such subcontractors
and consultants as it selects to the same extent it would if it had done such work itself; (b) the subcontractors and consultants
undertake in writing obligations of confidentiality and non-use regarding Confidential Information that are substantially the same
as those undertaken by the Parties pursuant to this Agreement; and (c) the subcontractors and consultants agree in writing to assign
all intellectual property developed in the course of performing any such work under the Research Program.

 

Reporting

 

INTERCEPT
shall submit to SERVIER: (i) a detailed interim written report on the progress of the Research Program, results obtained in
each 6 (six) month period during the Research Program Term and complete list of FTEs allocated to the Research Program as well
as the detail of the activities performed by such FTEs, within 60 (sixty) days of the end of each such 6 (six) month period, (ii)
a detailed written report of the results of the Research Program within 60 (sixty) days of the end of the Research Program Term;
and (iii) reports of any significant findings in the Research Program promptly upon such findings being made.

 

Coordinators
of the Research Program

 

The
Research Program shall be initially supervised and coordinated by Dr. Roberto Pellicciari
from INTERCEPT (hereinafter referred to as “INTERCEPT Coordinator”) and Pr Alain Ktorza from SERVIER (hereinafter referred
to as “SERVIER Coordinator”).

 

		2.2	Development
                                                           activities

 

		2.2.1	Regulatory preclinical development

 

For any Compound meeting the
criteria (as defined in the Research Program or in a separate written document), the JRDC will propose to the JSC to have such
Compound entering into regulatory preclinical development (hereinafter a “Selected Preclinical Compound”) provided
that SERVIER shall have the final decision in determining whether a Compound qualifies as a Selected Preclinical Compound or not,
in case the Parties disagree.

 

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For any Selected Preclinical
Compound, it is the Parties desire and intention to collaborate in planning and conducting the regulatory preclinical development
pursuant to the Pre-Clinical Development Plan to be proposed by the JRDC and approved by the JSC as soon as reasonably practicable
after designation of a Selected Preclinical Compound. Such Pre-Clinical Development Plan shall be designed, structured and conducted
in a manner that conforms to the applicable regulations of both the FDA and the EMA.

 

		2.2.2	Clinical development

 

(a) Clinical Development
Plan

 

The Parties desire and intend
to collaborate in planning and conducting the Clinical Trials of the Products in one or several Indications in the Field, as and
to the extent provided in this Agreement, and pursuant to a separate Clinical Development Plan for each Indication, it being understood
that each Party may act either itself or through one or more licensees, sublicensees or subcontractors in its respective territory
as permitted under this Agreement. The Clinical Development Plan shall set forth the specific activities to be conducted by each
Party and the estimated timeline for development of the Product in order to obtain the data that the Parties intend will be useful,
by both Parties, to obtain Regulatory Approvals of the Product in the United States of America and the EU.

 

(b) Sponsorship

 

Each Party shall be the sponsor
and shall have the final decision-making authority for all Clinical Trials conducted in its own territory, including those portions
of global or U.S. or EU Clinical Trials conducted in such territory and set forth in a Clinical Development Plan. Notwithstanding
the foregoing, neither Party shall have the unilateral right to decide any dispute with respect to the Clinical Trials, whether
pursuant to the Clinical Development Plan, or any Unsponsored Work, where the other Party believes in good faith that such a decision
would have a substantial likelihood of having a Material Impact; provided, however, that where such a decision involves the safety
of the Product in the deciding Party’s territory (including, by way of example, the content of the safety section of the
Product label, whether a recall should be conducted in such deciding Party’s territory, or whether a particular clinical
study should be terminated in its territory for safety reasons), the deciding Party shall nonetheless have the final say with respect
to such safety matter, notwithstanding that the other Party has asserted that the effect thereof has a substantial likelihood of
having a Material Impact.

 

(c) Conduct

 

Each Party shall use Commercially
Reasonable Efforts to carry out the activities assigned to it under the Clinical Development Plans. Each Party shall conduct its
activities under the Clinical Development Plans in a good scientific manner and in compliance in all material respects with all
applicable Laws.

 

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(d) Records and reports

 

Each Party
shall maintain complete and accurate records (in the form of technical notebooks and/or electronic files in C Disk format where
appropriate) of all work conducted by it or on its behalf under the Clinical Development Plans and all Information resulting from
such work. Such records, including any electronic files where such Information may also be contained, shall fully and properly
reflect all work done and results achieved in the performance of the Clinical Development Plans in sufficient detail and in good
scientific manner appropriate for patent and regulatory purposes. Each Party shall have the right to review and copy such records
maintained by the other Party at reasonable times, but no less than twice in any one calendar year, and to obtain access to originals
(including the databases) to the extent needed for patent or regulatory purposes or for other legal proceedings. Each Party shall
provide the other party and the JRDC with regular reports detailing its Development activities under the Clinical Development Plan
and the results of such activities at each regularly scheduled JRDC meeting, at a level of detail reasonably sufficient to enable
the other Party to determine the reporting Party’s compliance with its Commercially Reasonable Efforts obligations. The Parties
may agree to set up an electronic data room in order to manage the exchange of information in a secure manner.

 

(e) Unsponsored Work

 

Either Party
shall have the right, through the JRDC, to propose that one or more additional Clinical Trial(s) (beyond what is then included
in the applicable Clinical Development Plan) be conducted for development of the Product, and shall provide the JRDC with any supporting
data or publications supporting any such proposal. In such event, the JRDC shall consider such proposal and evaluate the supporting
data in good faith.

 

If both Parties’
JRDC representatives agree to conduct such proposed development, the JRDC shall prepare an amendment to the applicable Clinical
Development Plan to include the proposed Clinical Trials, for approval by the JSC.

 

If the non-proposing Party (i)
does not believe that such additional Clinical Trials are necessary for Regulatory Approval of the Product, (ii) does not wish
to fund such proposed activities, and (iii) does not reasonably believe that such proposed activities are substantially likely
to create a Material Impact, then the proposing Party shall have the right to perform the proposed activities (the “Unsponsored
Work”) at its own expense. The proposing Party shall deliver to the JRDC all proposed plans for such Unsponsored Work in
advance of commencing such activities and deliver an update on such Unsponsored Work at each meeting of the JRDC. Promptly following
completion of the Unsponsored Work, the proposing Party shall deliver to the JRDC the top-line data summary and shall disclose
all other Information resulting from such Unsponsored Work to the other Party. The non-proposing Party shall have access to and
the right to use all Information resulting from the Unsponsored Work solely as necessary to comply with the regulatory requirements
in its territory in particular with respect to safety reporting and a Party’s license rights to such Information shall be
limited solely to such purpose.

 

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(f) Subcontracting

 

Each
Party may perform any of its development obligations under this Agreement through one or more subcontractors and consultants upon
written notice to the JRDC, provided that (a) such Party remains responsible for the work allocated to, and payment to, such subcontractors
and consultants as it selects to the same extent it would if it had done such work itself; (b) the subcontractors and consultants
undertake in writing obligations of confidentiality and non-use regarding Confidential Information that are substantially the same
as those undertaken by the Parties pursuant to this Agreement; and (c) the subcontractors and consultants agree in writing to assign
all intellectual property developed in the course of performing any such work under the Clinical Development Plans to the Party
retaining such subcontractors or consultants.

 

(g) Personnel

 

All employees,
agents and subcontractors of each Party and its Affiliates conducting activities under this Agreement shall, prior to commencing
any such activities, be under written obligation to assign any inventions and related intellectual property rights to the Party
by whom they are employed or for whom they are providing services (or its designated Affiliate).

 

		2.2.3	Development Costs

 

Unless
otherwise provided, SERVIER shall fund in the first instance 100% of the costs (i) for the regulatory preclinical trials described
in the Pre-Clinical Development Plan and (ii) for Clinical Trials described in the Clinical Development Plan and conducted in SERVIER
Territory.

 

INTERCEPT shall reimburse to
SERVIER a portion of the Development Costs as follows:

 

(a) In case INTERCEPT gets a
partner for the development or commercialization of the Product in the USA before the end of Phase III Clinical Trials, or decides
to develop or commercialize the Product in the USA on its own, it will reimburse to SERVIER [***]% of the Development Costs supported
by SERVIER until such date and will directly contribute to [***]% of the future Development Costs.

 

(b) In case Intercept gets a
partner for the commercialization of the Product in the USA after the end of Phase III Clinical Trials, or decides to commercialize
the Product in the USA on its own, it will reimburse to SERVIER [***]% of the Development Costs.

 

The amounts to be reimbursed
(the “Refundable Amount”) by INTERCEPT to Servier according to the aforementioned provisions shall be paid to SERVIER
in equal quarterly installments over the thirty-six month period commencing with the date which is the earlier of (i) six months
following the date INTERCEPT gets a partner and (ii) the date of first New Drug Application filing with the FDA in which the clinical
data are being used (the “Reimbursement Period”). In addition, SERVIER shall be entitled to reduce by [***]% all milestones
and royalties that may become due by SERVIER to Intercept according to the Agreement during such Reimbursement Period until the
Refundable Amount has been fully reimbursed to SERVIER.

 

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In the event INTERCEPT gets
a partner solely for the development or commercialization of the Product in Japan and not in the USA, the Parties shall in good
faith determine which portion of the Development Costs is to be reimbursed by INTERCEPT to SERVIER and under which terms and conditions.

 

In the event INTERCEPT gets
no partner for the development or commercialization of the Product in the USA and/or Japan within three years following Regulatory
Approval of the Product in the EU, SERVIER shall have the exclusive right to negotiate with INTERCEPT to acquire exclusive license
rights on the Product (the “Object of Negotiation”) for the USA and/or Japan as applicable, and INTERCEPT shall not
solicit any offers, respond substantively to any inquiries except as required by Law or order after notice thereof to SERVIER,
conduct any negotiations or enter into any agreement with any Third Party regarding the Object of Negotiation without first either
conducting negotiations with SERVIER in accordance with this Section or receiving a written waiver from SERVIER of its rights under
this Section. Any negotiations required under this Section (“Negotiations”) will be initiated by SERVIER by written
notice to INTERCEPT. The Parties agree to conduct all Negotiations in good faith, with reasonable diligence and for a period of
not less than one hundred twenty (120) days or such other period as the Parties shall then agree (the “Exclusivity Period”),
and not to solicit any offers, respond substantively to any inquiries except as required by Law or order after notice thereof to
the other Party, conduct any negotiations or enter into any agreement with any Third Party regarding the Object of Negotiation
for at least such Exclusivity Period. In the event Negotiations are conducted in accordance with this Section but the Parties have
not reached agreement at the end of the Exclusivity Period, INTERCEPT shall be free to negotiate with Third Parties regarding the
Object of Negotiation; provided, however, that INTERCEPT shall not enter into any arrangement or agreement with a Third Party regarding
the Object of Negotiation on terms that are more favorable to such Third Party in any material respect than those that were last
the subject of such Negotiations were to SERVIER without first offering SERVIER a reasonable opportunity to enter into an agreement
with INTERCEPT on such more favorable terms. For the sake of clarity, to determine whether the terms negotiated with a Third Party
are more favorable to such Third Party than those discussed with SERVIER were to SERVIER, the Parties shall take into consideration,
inter alia, the Refundable Amount which would become due to SERVIER by INTERCEPT should INTERCEPT enter into a license agreement
with such Third Party.

 

Costs for all Territory-Specific
Work shall be borne solely by the Party conducting such work in its territory.

 

Costs for all Unsponsored Work
shall be borne solely by the Party proposing such work, subject to the following:

 

if, following completion of any
Unsponsored Work, the non-proposing Party wishes to have the right to use the resulting Information (beyond the rights pursuant
to Section 2.2.2 (e) above or pursuant to a Regulatory Authority requirement from a safety perspective), it may do so upon reimbursing
the proposing Party for [***] percent ([***]%) of its Development Costs related to such Unsponsored Work. Once the non-proposing
Party has reimbursed such amounts, the Information from such Unsponsored Work shall be included in the proposing Party’s
licensed know-how and the activities shall no longer be considered Unsponsored Work.

 

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		2.3	Committees

 

		2.3.1	Role of Committees

 

The Parties will establish several
committees (each a “Committee” and collectively the “Committees”), as follows:

 

Joint Executive Committee
(“JEC”). The JEC shall manage the overall collaboration strategy (including the intellectual property strategy),
discuss and approve or reject the recommendations of the JSC and resolve any disputed matter of the JSC. The JEC shall be composed
of an equal number of representatives of SERVIER and INTERCEPT.

 

Joint Steering Committee
(“JSC”). The JSC shall be composed of an equal number of representatives of SERVIER and INTERCEPT and shall
validate and follow-up on the research, development, manufacturing, regulatory and intellectual property strategies and the approval
of the recommendations of the corresponding committees. This includes in particular:

 

	(i)	 	approving criteria for Selected Preclinical Compound proposed by the JRDC;

 

	(ii)	 	upon proposal of the JRDC, approving if and when the above criteria have been met for a Compound;

 

	(iii)	 	upon proposal of the JRDC, approving the targeted pathology, the population and the expected indications for the Compound;

 

	(iv)	 	upon proposal of the JRDC, approving the Pre-Clinical Development Plan and the Clinical Development Plan including the design of the studies, methodologies, the choice of the doses and establishing the main criteria for demonstrating drug efficacy and following their implementation;

 

	(v)	 	upon proposal of the JRDC, approving a publication plan for the Compounds and Products;

 

	(vi)	 	making recommendations to the JEC; and

 

	(vii)	 	resolving matters in dispute before the JRDC.

 

Joint Research and Development
Committee (“JRDC”). The Parties shall establish a Joint Research and Development Committee composed of an equal
number of representatives of SERVIER and INTERCEPT. The JRDC shall include members who are competent in some or all of the following
disciplines: chemistry, pharmaceutical development pharmacology, safety pharmacology, toxicology, pharmacokinetics (ADME), clinical
development and regulatory affairs. The JRDC shall be responsible for developing (subject to JSC approval), overseeing the implementation
and assessing the research and development activities and the associated budget and in particular:

 

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	 	i.	 	monitoring the progress of the research and development activities;
	 	 	 	 
	 	ii.	 	drafting and proposing updates to the Pre-Clinical Development Plan and the Clinical Development Plan for approval (or rejection) by the JSC and implementing it once approved;
	 	 	 	 
	 	iii.	 	approving the pharmacological protocols;
	 	 	 	 
	 	iv.	 	defining and validating screening strategies;
	 	 	 	 
	 	v.	 	designing of the criteria for Selected Preclinical Compound;
	 	 	 	 
	 	vi.	 	evaluating if and when the above criteria have been met for a Compound;
	 	 	 	 
	 	vii.	 	defining the objectives of the non-clinical studies, their methodology, the choice of the doses;
	 	 	 	 
	 	viii.	 	designing of the criteria for non clinical work and evaluating if and when the end-points are met;
	 	 	 	 
	 	ix.	 	overseeing the set up of the studies;
	 	 	 	 
	 	x.	 	following up on the implementation of the studies;
	 	 	 	 
	 	xi.	 	reporting its activities to the JSC;
	 	 	 	 
	 	xii.	 	defining the objectives of the Clinical Trials, their methodology, the choice of the doses, the main criteria for evaluating success or failure and the statistical analysis plan;
	 	 	 	 
	 	xiii.	 	stipulating the objectives of chemical development (methodology, choice of chemical pathways, specifications and all other essential items);
	 	 	 	 
	 	xiv.	 	reviewing the protocols and reports for Clinical Trials and non-clinical studies;
	 	 	 	 
	 	xv.	 	reviewing the amendments to protocols for Clinical Trials and non-clinical studies;
	 	 	 	 
	 	xvi.	 	overseeing the set up of Clinical Trials and non-clinical studies, and reviewing their progress, follow-up and results;
	 	 	 	 
	 	xvii.	 	reviewing the studies’ specifications to ensure in particular the consistency of the clinical and non-clinical databases generated by or on behalf of the Parties with the Regulatory Authority requirements in the EU and in the USA;

 

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	 	xviii.	 	defining the way the results of the Clinical Trials and non-clinical studies will be publicly disclosed, in accordance with all applicable laws and Parties’ specific internal procedures;
	 	 	 	 
	 	xix.	 	reviewing the investigator brochures, product labels and package inserts; and
	 	 	 	 
	 	xx.	 	discussing and controlling the prosecution and maintenance of the patents in accordance with article 5.2 of this Agreement.

 

Notwithstanding
the tasks assigned to the JRDC, it is the intention of the Parties that nothing in this Agreement shall require the performance
of the activities described in the Pre-Clinical Development Plan and in the Clinical Development Plan in a manner that would result
in SERVIER being subjected to the jurisdiction of the courts of the USA or any of its territories or possessions. In the event
that SERVIER reasonably determines that performance of its obligations under Pre-Clinical Development Plan or the Clinical Development
Plan in accordance with this Agreement would subject SERVIER to such jurisdiction, then the Parties shall meet to discuss an alternative
approach to the conduct of such activities in a manner that avoids the creation of such jurisdiction but that preserves, insofar
as reasonably practicable, the rights and obligations of the Parties hereunder with respect to such activities. 

 

The
JRDC may appoint, if and when needed, sub-committees on specific matters such as marketing, intellectual property and manufacturing.

 

		2.3.2	Membership

 

Each of the Committees will be
made up of at least four (4) members, with an equal number of members from each of INTERCEPT and SERVIER.

 

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2.3.3  Meetings

 

Each Committee will be co-chaired
by one member that is a INTERCEPT representative and by one member that is a SERVIER representative. The Parties may change their
respective representatives upon written notice to the other Party. Meetings will alternate between the offices of the Parties,
or may be held via teleconference, videoconference or such other place or manner as the Parties may mutually agree. If a representative
of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative.
Each Party may, at its discretion, invite a member of a Committee to attend the meeting of another Committee. Each Party may also,
with the consent of the other Party, invite consultants or scientific advisors to attend the meetings of the Committee, provided
that such invitees are subject to written confidentiality and non-use agreements acceptable to the non-inviting Party. The Party
hosting any meeting shall appoint a secretary to the meeting who will record the minutes of the meeting which will be circulated
in draft form to all the members of the Committee promptly following the meeting for review, comment and adoption. The JEC and
the JSC shall meet at least twice a year, and the other Committees shall meet on a quarterly basis. Each Party shall be responsible
for its own costs for attendance and hosting of the meetings.

 

2.3.4  Decisions

 

All decisions of the Committees
shall be made by the co-chairmen, in the exercise of good faith. Such decisions (and the actions flowing therefrom) shall, insofar
as applicable, be consistent with (i) achieving a high quality type of research and development in order to maximize the global
commercial potential of the Products, (ii) the requirements of this Agreement, (iii) applicable ethical standards and (iv) applicable
laws.

 

With respect
to the JEC, in the event of a disagreement concerning a particular matter, the matter shall be referred to the Chief Executive
Officers (or their representatives) of both Parties for resolution. If the Chief Executive Officers (or their representatives)
cannot resolve the disputed matter within thirty (30) calendar days following the date of the written request of either Party to
refer the disputed matter to the Chief Executive Officers (or their representatives), then the matter in dispute is in dead-lock
unless and until such matter is solved. However the Parties shall continue the performance of the other matters in accordance with
the terms of this Agreement. For avoidance of doubt, this section shall not pertain to disputes arising out of or in connection
with the Parties’ respective rights and responsibilities under this Agreement, which such disputes shall be resolved in accordance
with the process described in section 10.2.

 

With
respect to the remainder of the Committees, in the event agreement cannot be reached between the Parties, the matter shall be referred
by either Party to the JSC, for resolution at the next meeting of the JSC. If the JSC cannot solve the disputed matter during such
meeting, the matter may be submitted by either Party to the JEC for resolution at the next meeting of the JEC in accordance with
the provisions immediately above.

 

    	page 19 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

		2.4	Exchange of data

 

During the term of
this Agreement, each Party (the “Disclosing Party”) shall provide to the other Party (the “Receiving
Party”), at no costs (unless expressly stated otherwise in the Agreement), all Data, to the extent Controlled by such
Party, in a timely fashion and as promptly as possible for use by the Receiving Party. The Receiving Party will only use and disclose
Data to Third Parties and Related Parties as may be necessary or useful for research, development, and manufacture of the Compounds
and Product(s), and the registration, promotion, distribution and commercialization of the Product(s), in its territory, in accordance
with this Agreement, or as may otherwise be agreed by INTERCEPT and SERVIER, provided that (i) the Receiving Party acknowledges
and agrees that the Data are disclosed by the Disclosing Party on an “as is” basis without any warranty of any kind,
(ii) the disclosure of such Data is made under reasonable and customary confidentiality restrictions. INTERCEPT may use the data
in discussions with potential partners or sublicensees for the USA and Japan, unless SERVIER reasonably determines that such disclosure
to such potential partner may have a Material Impact.

 

		2.5	CMC,
                                                                   manufacture and supply of Compounds and Products

 

INTERCEPT
will be in charge of the initial manufacturing and supply of each Compound (up to gram scale, i.e. up to the quantities that can
be produced by INTERCEPT at a laboratory level) for SERVIER, free of charge, during the period leading up to each such Compound
designation as a Selected Preclinical Compound during the Research Program Term. 

 

If
necessary, the Parties agree to sign a separate supply agreement covering the supply by INTERCEPT of Compounds to SERVIER, at
Cost of Goods if manufactured by a Third Party appointed by INTERCEPT or at Cost of Goods [***] percent ([***]%) if manufactured
directly by INTERCEPT or its Affiliates or the Third Party that supplied the lab scale Compound during the Research Program Term
(provided under no circumstances may the margin of such Third Party and of INTERCEPT or its Affiliates exceed in aggregate the
[***]% mark-up), after such period, for preclinical use, containing terms consistent with this article and such other terms as
are reasonable and customary for arrangements of this type. 

 

Promptly
following a Compound designation as a Selected Preclinical Compound, INTERCEPT will transfer to SERVIER, at no cost to SERVIER,
the manufacturing data, process and Know-How Controlled by INTERCEPT and all other data necessary for the CMC file and the manufacturing
of such Selected Preclinical Compound. Except as otherwise provided or agreed between the Parties, SERVIER shall be responsible
for the manufacturing of non-clinical and clinical treatment units for the conduct of the Pre-Clinical Development Plan and of
the Clinical Development Plan, for such Compound. 

 

    	page 20 of 67
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Upon
INTERCEPT’s request, SERVIER may agree to manufacture the non-clinical and clinical treatment units of such Compounds for
INTERCEPT’s use for Territory Specific Work or for Unsponsored Work, at Cost of Goods [***] percent ([***]%). 

 

Each
Party shall be responsible for the manufacturing of Product for commercial use, for its territories (being respectively SERVIER
Territory or INTERCEPT Territory). 

 

At
INTERCEPT’s request at any time, SERVIER will transfer to INTERCEPT the manufacturing data, process and know-how Controlled
by SERVIER and all other data necessary for the manufacturing of the Compound or Product in and for INTERCEPT Territory. The costs
incurred by SERVIER for such transfer shall be reimbursed by INTERCEPT to SERVIER.

 

All
the manufacturing activities to be conducted by the Parties will be detailed in a manufacturing plan (“Manufacturing Plan”)
to be reviewed and approved by the JRDC.

 

		2.6	Regulatory
                                                                   Submissions and use of Regulatory Documents

 

Each Party will be responsible
for the costs and efforts required to obtain Marketing Authorization, and pricing negotiations, in its territory. Each Party will
provide the other Party with copies of all draft material submissions (INDs, NDAs, Approval Applications, and any similar filings)
to be submitted after the Effective Date to Regulatory Authorities in the EU, Japan and USA and their possessions and territories
and, to the extent reasonably practicable or required by the Regulatory Authorities, all other material correspondence with Regulatory
Authorities in such jurisdictions, in each case, pertaining to the Compounds and/or Products. All such material submissions shall
be provided to the other Party promptly upon draft completion in order to permit such other Party to have a reasonable opportunity
(if reasonably possible twenty calendar(20) days) to review and comment on such draft submissions. Both Parties will make reasonable
efforts to provide advance copies of all such material correspondence to be sent to such Regulatory Authorities for review and
comment within the same time periods. After taking into consideration any comment from the other Party, the first Party shall
determine the final form of all material submissions and correspondence in its sole discretion. Final copies of all material submissions
and correspondence, including clinical database for individual studies, integrated analysis and case report forms, shall be promptly
provided to the other Party. Finally, each Party shall provide the other with a copy of the Regulatory Authority approval letter
(s) in its respective territory within ten (10) days of its receipt. In the event INTERCEPT would decide to license the rights
to INTERCEPT Technology for the INTERCEPT Territory to a Third Party, the above procedure relating to the provision of draft submissions
and other documents by INTERCEPT to SERVIER shall apply to such Third Party. Information provided under this provision shall include
but not be limited to:

 

		·	briefing
                                                                                                                     books and
                                                                                                                     slides relating
                                                                                                                     to consultation
                                                                                                                     meetings
                                                                                                                     with Regulatory
                                                                                                                     Authorities;

 

		·	IND:
                                                                                                                     initial submissions,
                                                                                                                     serials,
                                                                                                                     annual updates
                                                                                                                     (to be submitted
                                                                                                                     for information
                                                                                                                     purposes
                                                                                                                     only);

 

		·	Clinical
                                                                                                                     reports of
                                                                                                                     pivotal studies;

 

    	page 21 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

		·	Module
                                                                                                                     2 overviews
                                                                                                                     ;

 

		·	Module
                                                                                                                     2 summaries;

 

		·	CMC
                                                                                                                     module 3
                                                                                                                     files;

 

		·	Non
                                                                                                                     clinical
                                                                                                                     module 4
                                                                                                                     files;

 

		·	Clinical
                                                                                                                     module 5
                                                                                                                     files ;

 

		·	Draft
                                                                                                                     labeling
                                                                                                                     and packaging
                                                                                                                     labeling
                                                                                                                     for Products
                                                                                                                     only at the
                                                                                                                     stage of
                                                                                                                     Approval
                                                                                                                     Application,
                                                                                                                     not at the
                                                                                                                     stage of
                                                                                                                     clinical
                                                                                                                     trials applications;
                                                                                                                     and

 

		·	Answers
                                                                                                                     to questions.

 

All time frames and deadlines
for reviewing or responding set forth in this Section are subject to any shorter time frames imposed by a Regulatory Authority
or reasonably required by the circumstances.

 

INTERCEPT or SERVIER, as applicable,
shall notify the other Party within forty-eight hours after it receives information about the initiation of any investigation,
review or inquiry by any Regulatory Authority that such Party determines in good faith could have an adverse impact on either
Party’s ability to perform its obligations hereunder, including without limitation any such investigation, review or inquiry
concerning non-clinical or clinical research relating to the Compounds or Products or the manufacturing of the Compounds or Products.
The Parties shall coordinate in good faith towards a strategy for preparing for and responding to any such investigation, review
or inquiry and each Party shall take such reasonable measures to support the other Party in such activities as such other Party
may reasonably request, including by participating in meetings or providing materials for such an investigation, review or inquiry.
For avoidance of doubt, the foregoing shall not apply to any ordinary course interactions with Regulatory Authorities relating
to a Party’s planning, conduct or evaluation of a Clinical Trial of a Product.

 

		2.7	Ownership
                                                                      of Approval Applications and Marketing Authorizations

 

Each
Party shall own all right, title and interest in all Approval Applications in countries in its respective territory. One Party
shall not be entitled to use, or grant to Third Parties any rights to use, Approval Applications in the other Party’s territory.

 

Each
Party shall be the holder of all Marketing Authorizations in countries in its territory, and shall be responsible for the filing
thereof, the payment of fees and all other associated costs.

 

    	page 22 of 67
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		2.8	Commercialization

 

Subject to the terms
and conditions of this Agreement, SERVIER shall be solely responsible at its costs and shall use Commercially Reasonable Efforts
to promote and commercialize the Product(s) in SERVIER Territory using the same level of efforts as with SERVIER’s other
similar products of similar sales potential.

 

2.9         Pharmacovigilance;
Exchange of Safety Information and Quality Issues

 

Each
Party will designate a pharmacovigilance liaison to be responsible for communicating with the other Party regarding the reporting
of adverse drug reactions/experiences.

 

The
Parties will cooperate in the collection, review, assessment, exchange, tracking and filing of information related to adverse
events and quality issues associated with the Compounds and Products in accordance with all applicable laws. As soon as necessary,
the pharmacovigilance and regulatory departments of both Parties shall meet and determine the approach to be taken for the collection,
review, assessment, tracking and filing of information related to adverse events and quality issues associated with the Compounds
and Products, which shall be documented in a separate safety data exchange and quality agreements which shall be in compliance
with all applicable laws (respectively the “Safety Data Exchange Agreement”
and the “Quality Agreement”) between the Parties (provided, however, that
the Agreement shall control in the event of any conflict between the terms of this Agreement and respectively the Safety Data
Exchange Agreement and the Quality Agreement). These documents as well as a safety management plan shall be finalized prior to
Clinical Trials Initiation. 

 

The
Safety Data Exchange Agreement and the Quality Agreement will be promptly updated if required by changes in legal requirements
or by agreement between the Parties.

 

		2.10	Reports;
                                                                                         Inspection; Assignments

 

Each
Party shall prepare and maintain, and contractually require that its sublicensees and its and their respective Third Party manufacturers
and Third Party contractors prepare and maintain, accurate and complete records of all research and development work performed
with respect to the Compounds and/or Products, to enable the Parties to comply with applicable laws, to prepare Approval Applications,
to prepare and submit applications for Patent Rights and to otherwise comply with the requirements of this Agreement. All such
agreements shall also require that such sublicensees and Third Parties assign all rights in inventions pertaining to the Compounds
and/or Products to the relevant Party to this Agreement or grant to such Party a royalty-free, worldwide perpetual license, with
the right to grant sublicenses through multiple tiers, to practice such inventions for the purpose of researching, developing,
making, using, selling, importing and commercializing the Compounds and Products. A Party, or such Party’s authorized representatives,
may visit only those portions of the facilities of the other Party or their Third Party contractors or Third Party manufacturers
where development is being performed during normal business hours upon reasonable notice without undue interruption to normal
business operations.

 

    	page 23 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

 

		2.11	Regulatory Inspections

 

If either Party, its Affiliates
and its sublicensees or any of its respective subcontractors (each, an “Inspected Party”) are to be inspected
by a Regulatory Authority regarding the development, manufacture, registration or commercialization of a Compound and/or Product,
the Inspected Party shall within forty-eight (48) hours notify the other Party of the inspection in writing, and in advance, if
any such inspection is a scheduled inspection. The Inspected Party shall, where practicable, permit representatives of the other
Party to participate as observers with respect to such inspection, and shall provide the other Party with a written report of any
such inspection, noting with specificity any records or documents reviewed by the regulatory inspector, or written communications
provided by or to any Regulatory Authority relating to such inspection. The Inspected Party shall also provide an opportunity for
the other Party to assist in responding to any issues or concerns relating to such inspections, and shall provide copies of all
communications to and from any Regulatory Authority relating thereto to the other Party. The Parties shall cooperate in good faith
and otherwise mutually support any regulatory inspections of facilities, clinical sites, contract manufacturers or the like with
respect to a Compound and/or Product, including by using Commercially Reasonable Efforts to make available such facilities, documents,
information and/or personnel as are reasonably necessary or useful for such regulatory inspections by a Regulatory Authority. The
rights in this Section shall only apply to Parties, their Affiliates, sublicensees and their respective contractors to the extent
the relevant inspection pertains to research and development activities, or pertains to manufacturing facilities and services being
performed for the benefit of the other Party.

 

		2.12	Audit Rights

 

Each Party shall have the right,
during normal business hours, and no more than once per year, with more frequent audits upon agreement of the Parties (such agreement
not to be withheld unreasonably), to inspect and audit: (a) those portions of the facilities of each Party, or any of its Affiliates,
and subcontractors used in connection with the Compound and/or Products to ascertain compliance with applicable laws and Marketing
Authorizations, including current cGCP and cGMP, provided that the inspecting Party shall on such occasions be accompanied by a
representative of the other Party; and (b) any of the other Party’s documentation, or its Affiliates’ or subcontractors’
documentation, relating to the Compound and/or Products and, to the extent permitted by any applicable laws, the medical records
of any patient participating in any Clinical Trial being conducted by such Party or its Affiliates. A Party’s audit rights
shall be limited by bona fide Third Party agreements or confidentiality obligations, provided, however, that each Party shall use
reasonable efforts to obtain audit and inspection rights for the other Party under such agreements; and if a Party is unable to
obtain such audit rights for the other Party, then upon request it shall exercise its own rights with respect to such an audit
for the benefit of the other Party. The rights in this Section shall only enable audits pertaining to research and development
activities, or pertaining to manufacturing facilities and services being performed for the benefit of the other Party.

 

    	page 24 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

Article
3: licenses

 

		3.1	Licenses

 

		3.1.1	Research and development license by INTERCEPT to SERVIER

 

Subject to the terms and
conditions of this Agreement, INTERCEPT hereby grants to SERVIER during the Term a royalty-free, exclusive (even as to INTERCEPT
and its Affiliates) right and license, with the right to grant sublicense rights as set forth below, in and/or for the SERVIER
Territory, under the INTERCEPT Technology solely to carry out its activities and responsibilities under the terms of this Agreement.
For avoidance of doubt, such right and license shall include the right to research, use, and have used, develop, have developed,
make, have made, in and/or for the SERVIER Territory, Compounds and Products, in relation with the performance of its research
and development activities (including CMC and manufacturing activities).

 

		3.1.2	Commercialization license by INTERCEPT to SERVIER

 

Subject to
the terms and conditions of this Agreement, INTERCEPT hereby grants to SERVIER, during the Term, a royalty bearing, exclusive (even
as to INTERCEPT and its Affiliates) right and license, with the right to grant sublicense rights as set forth below, under the
INTERCEPT Technology, to make, have made, use, have used, offer for sale, lease, market, sell, have sold and import and export
Products, solely for use in the Field, in and/or for the SERVIER Territory.

 

Such license
may be extended, at SERVIER’s request, to Indications outside of the Field under terms and conditions to be discussed in
good faith between the Parties.

 

		3.1.3	Sublicense Rights

 

SERVIER shall
have the right to grant sublicenses of the rights granted to SERVIER by INTERCEPT (i) to Affiliates without prior written consent
of INTERCEPT and (ii) to Third Parties with the prior written consent of INTERCEPT.

 

SERVIER shall
ensure that any sublicensee to which it sublicenses the rights granted to SERVIER by INTERCEPT is required to comply with at least
the same material obligations as SERVIER under this Agreement, and SERVIER shall remain liable for any breach by its sublicensees
of the terms and conditions of this Agreement with respect to such sublicenses. 

 

    	page 25 of 67
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		3.1.4	Research and development license by SERVIER to INTERCEPT

 

Subject to
the terms of this Agreement, SERVIER hereby grants to INTERCEPT as of the Effective Date a non-exclusive, non-royalty bearing,
non-sublicensable license under SERVIER Technology solely for the purpose of allowing INTERCEPT to carry out its activities and
responsibilities under the Research Program and for the Research Program Term.

 

		3.1.5	Commercialization license by SERVIER to INTERCEPT

 

Subject to
the terms and conditions of this Agreement, SERVIER hereby grants to INTERCEPT, during the Term, a non-royalty bearing, exclusive
(even as to SERVIER and its Affiliates) right and license, with the right to grant sublicense rights as set forth below, under
the SERVIER Technology, to make, have made, use, have used, offer for sale, lease, market, sell, have sold and import and export
Products, solely for use in the Field, in and/or for the INTERCEPT Territory.

 

		3.1.6	Sublicense Rights

 

INTERCEPT shall
have the right to grant sublicenses of the rights granted to INTERCEPT by SERVIER (i) to Affiliates without prior written consent
of SERVIER and (ii) to Third Parties with the prior written consent of SERVIER.

 

INTERCEPT shall
ensure that any sublicensee to which it sublicenses the rights granted to INTERCEPT by SERVIER is required to comply with at least
the same material obligations as INTERCEPT under this Agreement, and INTERCEPT shall remain liable for any breach by its sublicensees
of the terms and conditions of this Agreement with respect to such sublicenses.

 

		3.2	No Other Rights and Retained Rights

 

This
Agreement confers no right, license or interest by implication, estoppel, or otherwise under any Patent Rights, Know-How or other
intellectual property rights of either Party except as expressly set forth in this Article (Licenses) and elsewhere in this Agreement.
Each Party hereby expressly retains and reserves all rights and interests with respect to patents, patent applications, know-how
or other intellectual property rights not expressly granted to the other Party hereunder.

 

Notwithstanding the foregoing
and any provision to the contrary, during the Term, INTERCEPT shall not, directly or indirectly, commercialize the Products (even
for a Product for which the development/commercialization has been stopped by SERVIER) outside of the Field in the Territory.

 

    	page 26 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

Article
4: Financial terms

 

		4.1	General

 

Unless otherwise
provided, all payments due pursuant to this Agreement shall be payable within thirty (30) calendar days after receipt of the corresponding
invoices. For each specific payments due by SERVIER, SERVIER shall notify in due time to INTERCEPT which legal entity between Les
Laboratoires Servier and Institut de Recherches Servier has to be invoiced.

 

		4.2	Upfront Payment

 

SERVIER shall pay to INTERCEPT
a one-time, non-refundable upfront cash payment of one million Euros (€1,000,000)
upon signature of the Agreement and within ten (10) business days of receipt of the corresponding
invoice.

 

		4.3	Research program funding

 

SERVIER shall reimburse to INTERCEPT
a portion of the FTE costs borne by INTERCEPT for the conduct of the Research Program, up to a maximum amount of [***] euros per
year for the Research Program Term. The details of this funding are set forth in section 2.1 of this Agreement.

 

		4.4	Milestone Payments

 

		4.4.1	Milestone payments for development events

 

SERVIER will
pay to INTERCEPT the following success-based milestone payment for development events:

 

	Milestone event	 	Milestone payment (in euros)
	[***]. 	 	€[***]
	[***].	 	€[***]
	[***].	 	€[***]
	Decision by SERVIER to initiate the first Phase III Clinical Trial for the first Product.	 	€4 million

 

		4.4.2	Milestone payments for regulatory and commercial events

 

SERVIER will
pay to INTERCEPT the following success-based milestone payment for regulatory and
commercial events:

 

	Milestone event	 	Milestone payment (in euros)
	[***].	 	€[***]
	First Regulatory Approval by EMA for the first Product in a first indication.	 	€5 million
	[***].	 	€[***]
	First Commercial Sale of the first Product in one of the following countries: France, Germany, UK.	 	€10 million

 

    	page 27 of 67
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		4.4.3	Milestone payments for sales thresholds

 

SERVIER will make to INTERCEPT
one-time sales milestone payments when the aggregate Net Sales of a Product first reach the thresholds specified below in any [***]
([***])-month period within 30 days of such event occurring:

 

	Net Sales thresholds	 	Milestone payment in euros
	€200 Million	 	€10 million
	€400 Million	 	€20 million
	€500 million	 	€25 million
	€600 million	 	€25 million

 

		4.5	Royalties

 

		4.5.1	Royalties level

 

SERVIER shall pay the following
tiered royalties on the Net Sales.

 

	Aggregate Net Sales in each year following

the First Commercial Sale in SERVIER

Territory(1)	 	Royalty (percentage of Net
 Sales)
	≤ €[***]	 	[***]%
	> €[***]	 	[***]% (only for the portion of Net Sales exceeding €[***])

 

Royalties shall be paid in SERVIER
Territory on a Product by Product and country by country basis from the [***] until (i) the [***] or (ii) [***], whichever occurs
later.

 

(1) For the sake of clarity,
the aggregate Net Sales shall not include the portion of the Net Sales for which a reduced royalty is applicable because of the
occurrence of royalty reduction events as set forth in article 4.5.2 below.

 

		4.5.2	Royalty reduction events

 

If at any time following the
First Commercial Sale in a country in the SERVIER Territory, one or several Generic Competitor(s) of a Product in a given country
for which royalties would otherwise be due under this Article represent(s) in units [***]% or more of the market share in that
country for any calendar quarter, then the royalty rate for sales in that country for such quarter shall be [***]% of Net Sales.

 

    	page 28 of 67
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If SERVIER has to pay royalties
prospectively to Third Parties for patent rights that cover the manufacture, use, sale, importation, or offer to sell Products
(regardless of whether such payments are pursuant to a license, a settlement agreement, a court order or a similar obligation),
then, the royalty payment made by SERVIER to INTERCEPT hereunder shall be reduced by the amount paid to such Third Party (“Royalty
Reduction”). The Royalty Reduction shall be determined on a Product by Product basis and shall be carried forward for
application in future periods until such Third Party payments have been offset as provided herein.

 

The above notwithstanding, under
no circumstances may the application of the royalty reduction events result in the royalty rate being reduced below 1%.

 

		4.5.3	Royalty Payments and Reports

 

SERVIER shall provide a report
to INTERCEPT within thirty (30) days after the end of each Calendar Quarter, certified by an executive officer of SERVIER as accurate
and in accordance with generally accepted accounting principles, as consistently applied by SERVIER across all of SERVIER’s
products, on a country-by country-basis and a Product-by-Product basis, setting forth (a) the amount of gross sales of Products
in such Calendar Quarter, (b) any deductions, withholding, provision from such amount of gross sales as permitted pursuant to the
definition of Net Sales, (c) a calculation of Net Sales of each Product for such Calendar Quarter, (d) the amount of aggregate
Net Sales of each Product on a cumulative per year basis for the current year, and (e) the amount of royalty due on Net Sales with
respect to such Calendar Quarter. Within fifteen (15) days after sending the abovementioned report, SERVIER shall make all royalty
payments payable to INTERCEPT under this Agreement with respect to such Calendar Quarter. Along with such payments, SERVIER shall
also provide detailed information regarding the calculation of royalties due pursuant to this article, including without limitation
allowable deductions in the calculation of Net Sales of Products in SERVIER Territory.

 

		4.6	Records and audit

 

SERVIER
shall keep, and shall contractually require that its Affiliates and sublicensees keep, such records as are required to determine
the sums or credits due under this Article 4, including without limitation Net Sales in countries where Products are sold. At the
request of INTERCEPT, SERVIER and its Affiliates and its sublicensees shall permit an independent certified public accountant appointed
by INTERCEPT and reasonably acceptable to SERVIER, its Affiliates and its sublicensees, at reasonable times and upon reasonable
notice, to examine those records as may be necessary to determine, with respect to any calendar year ending not more than three
(3) years prior to INTERCEPT’ request, the correctness or completeness of any report or payment made under this Article 4.
The foregoing right of review may be exercised only once per year and only once with respect to each such periodic report and payment.
Results of any such examination shall be (a) limited to information relating to Products, (b) made available to both Parties and
(c) subject to the confidentiality provisions set forth below. INTERCEPT shall bear the full cost of the performance of any such
audit, unless such audit discloses a variance to the detriment of INTERCEPT of more than [***] percent ([***]%) from the amount
of the original report, royalty or payment calculation. In such case, SERVIER shall bear the full cost of the performance of such
audit. SERVIER shall contractually require that its Affiliates and sublicensees submit to the exercise of INTERCEPT’s right
of audit hereunder.

 

    	page 29 of 67
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		4.7	Taxes and Withholding

 

All
payments due and payable under this Agreement will be made without any deduction or withholding for or on account of any tax unless
such deduction or withholding is required by applicable laws. If the paying Party is so required to deduct or withhold, such Party
will (a) promptly notify the other Party of such requirement, (b) pay to the relevant authorities the full amount required to be
deducted or withheld promptly upon the earlier of determining that such deduction or withholding is required or receiving notice
that such amount has been assessed against the other Party, and (c) promptly forward to the other Party an official receipt (or
certified copy) or other documentation reasonably acceptable to the other Party evidencing such payment to such authorities.

 

		4.8	Currency

 

All amounts due and payable and
calculations relating to Net Sales and royalties hereunder shall be in Euros. As applicable, Net Sales shall be translated from
other currencies into euros using the monthly average of daily rates of exchange published by European Central Bank for the monthly
period in which Net Sales are accounted.

 

		4.9	Late payments

 

SERVIER shall make all payments
due and payable to INTERCEPT under this Agreement by wire transfer of immediately available funds to such account designated by
INTERCEPT from time to time to SERVIER in writing in accordance with the provisions of this Article. If any sum due and payable
under this Agreement shall not have been paid on or before the applicable due date, simple interest shall accrue on the unpaid
amount at the rate of Euribor (1 month) plus [***] per cent ([***]%) per annum or the minimum interest rate applicable in accordance
with the laws of France, whichever is the greater; provided, however, that no interest shall accrue on any portion of an unpaid
amount which is the subject of a good faith, legitimate dispute. If any such dispute is resolved against SERVIER, the date of resolution
shall be deemed the date that payment to INTERCEPT originally was due.

 

    	page 30 of 67
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Article
5: INTELLECTUAL PROPERTY

 

		5.1	Inventorship And Ownership of Intellectual Property

 

		5.1.1	Inventorship

 

Inventorship
of inventions shall be determined in accordance with rules and guidelines regarding inventorship as established under the applicable
patent law of the country in which the patent issued or the application is pending.

 

		5.1.2	Ownership

 

5.1.2.1As between the Parties,
except as expressly provided herein, including without limitation, as provided in the licenses and covenants set forth in Article
3 (Licenses) above, SERVIER shall retain all right, title and interest in and to SERVIER Patent Rights and SERVIER Know-How, including
any SERVIER Inventions conceived, reduced to practice or otherwise developed by or on behalf of SERVIER or one of its Affiliates,
and all intellectual property rights claiming such SERVIER Inventions.

 

5.1.2.2As between the Parties,
except as expressly provided herein, including without limitation, as provided in the licenses and covenants set forth in Article
3 (Licenses) above, INTERCEPT shall retain all right, title and interest in and to the INTERCEPT Patent Rights and INTERCEPT Know-How,
including any INTERCEPT Inventions conceived, reduced to practice or otherwise developed by or on behalf of INTERCEPT or one of
its Affiliates, and all intellectual property rights claiming such INTERCEPT Inventions.

 

5.1.2.3All Joint Patent Rights
and Joint Know-How shall be jointly owned by SERVIER and INTERCEPT, on the basis of an equal undivided interest, with the rights
and obligations set forth herein, including as set forth in this Section 5.1.2.3. Except as expressly set forth in this Agreement,
including without limitation, as set forth in the provisions in Article 3 (Licenses) each Party shall have the right, to freely
exploit, directly or through its Affiliates, transfer, license or encumber its rights in any such Joint Patent Rights and Joint
Know-How without the consent of or payment or accountancy to the other Party and each Party waives any right it may have under
the laws of any jurisdiction to require such consent, payment or accounting. This provision shall survive termination of this Agreement.

 

    	page 31 of 67
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		5.1.3	Disclosure

 

In the event that during the
Term, either Party (the “Inventing Party”), its Affiliates or its sublicensees develops any Inventions with
respect to a Compound, or Product that are Controlled by the Inventing Party or its Affiliates or its sublicensees, the Inventing
Party shall furnish the other Party with notice complete written disclosure of such Inventions promptly after their conception.
As to such Inventions that are Improvements, the Inventing Party shall furnish the other Party with a complete written disclosure
of any such Improvements promptly after conception of such Improvements, with the goal of making such disclosure within a thirty
(30) day period. When Data has been produced relating to such Improvements, the Inventing Party shall furnish the other Party with
a data package which, in the Inventing Party’s reasonable opinion, contains all material information, Know-How and other
Data available to the Inventing Party that would be useful for the other Party to obtain Regulatory Approvals in its territory
for such Improvements, and to implement such Improvements in the other Party’s manufacture, production, research, development,
packaging, marketing, promotion, distribution, sale and/or use of the Product in its territory. All such information, Know-How
and other Data with respect to any such Improvements shall be deemed to constitute the Inventing Party’s Know-How, and the
other Party shall have the right to use such Inventing Party’s Know-How, at no additional charge in accordance with the license
grants in Article 3 (Licenses), subject to the limitations, of this Agreement. As to such Inventions that are Controlled by the
Inventing Party but that are not Improvements, the Inventing Party shall furnish the other Party with a complete written disclosure
of any such Inventions promptly after the conception of such Inventions. The other Party shall have the right to use any such Inventions
at no additional charge, in accordance with the license grants in Article 3 (Licenses), if applicable, and the other terms and
conditions, and subject to the limitations, of this Agreement.  

 

		5.2	Filing, Prosecution and Maintenance of Patents –
reimbursement of Patent costs

 

5.2.1
Filing, prosecution and maintenance of patents for INTERCEPT Inventions and INTERCEPT Patent Rights

 

INTERCEPT
shall prepare all patents for INTERCEPT Inventions. As of the Effective Date and until the grant of patents, INTERCEPT shall, under
the JRDC’s control (especially for the date of first submission of any new patent application and the determination of the
date and list of countries where to apply), be in charge of the filing, prosecution and maintenance of INTERCEPT Inventions and
INTERCEPT Patent Rights, and SERVIER shall reimburse to INTERCEPT 50% of the duly justified costs borne by INTERCEPT during such
phase of prosecution and maintenance. Thereafter, starting from the grant of patents, SERVIER shall, at its own costs and under
the JRDC’s control, be in charge of the validation and maintenance of INTERCEPT Inventions and INTERCEPT Patent Rights in
and for the SERVIER Territory in the Field. 

 

As
soon as a filing can proceed in accordance with the above terms, the Party responsible for filing (“Responsible Party”)
shall promptly and diligently file, prosecute, seek prompt issuance of, and maintain patent applications according to its own internal
standards for effectively covering inventions made by the employees of either Party or of any third party pursuant to the performance
of the Agreement. The Responsible Party will submit for the other Party’s approval a substantially complete draft including
substantially complete claims of each such patent application at least thirty (30) days prior to the contemplated filing date,
and the other Party agrees to provide final comments within two weeks thereof. In the event of disagreement between the Parties,
this disagreement will be resolved by the JSC. The Responsible Party will provide the other Party within fifteen (15) days copies
of all documents and official letters exchanged between the Responsible Party and any Third Party and/or patent office relating
to the patent application in question. If at any time SERVIER decides not to file or maintain, or to pay for filing and maintenance
of, as applicable, a patent application or patent covering INTERCEPT Inventions or part of INTERCEPT Patent Rights in any jurisdiction
within SERVIER Territory, it shall promptly notify INTERCEPT of that decision and at least 60 days before the expiration of such
rights and any such patent applications and patents in such jurisdiction(s) shall no longer be subject to the licenses granted
herein (and SERVIER shall thereafter not be obligated to share in any costs thereof). 

 

    	page 32 of 67
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		5.2.2	Filing and prosecution of Patents Rights for Joint Inventions

 

Promptly after conception of
Joint Inventions, the Parties shall confer to determine whether and when to seek Joint Patents Rights for such Joint Inventions.
As to those Joint Inventions selected for filing of Joint Patents Rights, the Parties shall jointly be responsible for preparing,
filing, prosecuting, and maintaining Joint Patents Rights in such countries as the Parties agree all in accordance with the Parties
overall prosecution and maintenance strategy; provided that INTERCEPT shall be in charge of implementing such overall strategy
in jurisdictions in the INTERCEPT Territory and SERVIER shall be in charge of implementing such overall strategy in jurisdictions
within SERVIER Territory. Should the Parties disagree in the JRDC on the overall prosecution and maintenance strategy (such as
for example on the date of first submission of any new patent application), the disputed matter will follow the procedure described
in article 2.3.4 above.

 

All reasonable expenses associated
with preparing, filing, prosecuting and maintaining Joint Patents Rights shall be equally shared by the Parties, provided that
if either Party desires not to file or maintain such a patent application or patent, it shall notify the other Party of that desire
and it shall, at such other Party’s request, assign to such other Party the right to file patent applications claiming such
Joint Inventions in such jurisdictions, in such other Party’s own name, and such other Party shall own all right, title and
interest in and to such patent applications and any patents issuing therefrom in such jurisdictions and such patent applications
and any patents issuing therefrom shall no longer be subject to the licenses granted herein (and the assigning Party shall thereafter
not be obligated to share in any costs thereof). To the extent filing and prosecution is conducted through an external patent law
firm this will be a mutually acceptable law firm.

 

		5.2.3	Offer of assignment from one Party to the other

 

The Party receiving an offer
hereunder of assignment of any patent or application therefore, shall accept or decline the offer in writing within sixty (60)
days after receipt of such offer. The failure to respond in writing to any such offer shall be construed as declining the offer
and as authority for the offering Party to abandon and/or discontinue maintaining any patents or patent applications covered by
such offer. If such an offer of assignment is accepted, the assigning Party shall at no cost to the other Party execute all lawful
documents required to assign such patent or prosecute and maintain such patents and applications, and to transfer ownership of
such patents or applications to the Party requesting an assignment in response to an offer to assign as set forth herein, and such
patent applications and any patents issuing therefrom shall no longer be subject to the licenses granted herein.

 

    	page 33 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

		5.2.4	Defense of Data exclusivity

 

SERVIER, in good faith consultation
with INTERCEPT, will determine a strategy to obtain and defend Data exclusivity for the Products in SERVIER Territory. Each Party
will promptly make available to the other Party any available information that is relevant for any material issue of obtaining
or defending the Data exclusivity for the Product in SERVIER Territory. Each Party will provide any lawful formal support, signatures,
evidence or other documents relevant to the defending Party with respect to such Data exclusivity. The expenses relating to obtaining
or defending Data exclusivity in SERVIER Territory will be the sole responsibility of SERVIER.

 

		5.3	Infringement

 

		5.3.1	Infringement by Third Parties

 

If, during the Term of this Agreement,
either Party becomes aware of any Third Party infringement or threatened infringement of any of the INTERCEPT Patent Rights or
SERVIER Patent Rights or Joint Patent Rights or any unauthorized use thereof, the following provisions shall apply:

 

		5.3.2	In-licensed Patent Rights

 

To the extent a Party Controls
(for purposes of this Agreement) intellectual property of a Third Party (a “Third Party Licensor”) as a result
of a license or other grant of rights to such intellectual property from such Third Party (such intellectual property, the “In-Licensed
Rights”, and the agreement granting such rights to such intellectual property, the “In-License”),
the terms of such In-License shall govern efforts to prevent, prohibit or terminate any actual or threatened infringement or unauthorized
use of the In-Licensed Rights granted pursuant to such In-License; provided that, the Party Controlling the In-Licensed Rights
shall use Commercially Reasonable Efforts to obtain from the Third Party Licensor the right to respond to such infringement or
unauthorized usage as provided in this Article 5.3. Moreover, each Party and its Affiliates and its sublicensees shall be required
to take such measures as may be reasonably necessary or convenient to enable such Party to fulfill its obligations hereunder pertaining
to the prosecution, maintenance and enforcement of any In-Licensed Rights as provided in any In-License.

 

		5.3.3	Notice

 

The Party having knowledge of
an infringement as described in Section 5.3.1 shall promptly give notice to the other Party, with all available details of such
infringement.

 

    	page 34 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

		5.3.4	In SERVIER Territory for INTERCEPT Patent Rights and Joint Patent Rights

 

SERVIER shall have the first
right, but not the obligation, to bring suit for infringement of INTERCEPT Patent Rights or Joint Patent Rights in SERVIER Territory
in its name, or in the name of INTERCEPT if necessary, at its own expense, to restrain such infringement or unauthorized use and
to recover profits and damages, or to otherwise halt the infringement. INTERCEPT agrees to being joined as a Party plaintiff in
any such suit and to cooperate in the litigation thereof as is reasonably necessary, at the expense of SERVIER. If SERVIER decides
to undertake such suit, then SERVIER shall have the sole right to control litigation, and the right to settle such action, provided,
however that any such settlement shall require the prior written consent of INTERCEPT, which consent shall not be unreasonably
withheld. INTERCEPT shall provide SERVIER with such assistance as SERVIER shall reasonably request and reasonably compensate INTERCEPT
in connection with any action to prevent or enjoin any such infringement or unauthorized use of the INTERCEPT Patent Rights or
Joint Patent Rights.

 

INTERCEPT back-up right. If SERVIER
fails to take any preliminary action to the initiation of a suit or otherwise halt such infringement or unauthorized use of the
INTERCEPT Patent Rights or Joint Patent Rights in SERVIER Territory within sixty (60) days after becoming aware of any such infringement,
in the first instance or by notice from INTERCEPT, then INTERCEPT, at any time prior to SERVIER thereafter filing an action for
infringement, shall have the right but not the obligation, at its own expense, to take such action in its own name as it deems
necessary or appropriate. SERVIER shall cooperate with INTERCEPT as is reasonably necessary in any such action brought by INTERCEPT
and at no expense to INTERCEPT. SERVIER may elect to join or intervene in any such action brought by INTERCEPT in its own name,
at the expense of SERVIER, and be represented by its own counsel. If INTERCEPT brings legal action for patent infringement or to
otherwise halt unauthorized use of the INTERCEPT Patent Rights or Joint Patent Rights, INTERCEPT shall have the sole right to control,
and settle such action with the prior written consent of SERVIER, which consent shall not be unreasonably withheld.

 

		5.3.5	In INTERCEPT Territory for Joint Patent Rights

 

INTERCEPT shall have the first
right, but not the obligation, to bring suit for infringement of Joint Patent Rights in INTERCEPT Territory in its name, or in
the name of SERVIER if necessary, at its own expense, to restrain such infringement or unauthorized use and to recover profits
and damages, or to otherwise halt the infringement. SERVIER agrees to being joined as a Party plaintiff in any such suit and to
cooperate in the litigation thereof as is reasonably necessary, at the expense of INTERCEPT. If INTERCEPT decides to undertake
such suit, then INTERCEPT shall have the sole right to control litigation, and the right to settle such action, provided, however
that any such settlement shall require the prior written consent of SERVIER, which consent shall not be unreasonably withheld.
SERVIER shall provide INTERCEPT with such assistance as INTERCEPT shall reasonably request in connection with any action to prevent
or enjoin any such infringement or unauthorized use of Joint Patent Rights.

 

    	page 35 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

SERVIER back-up Right. If INTERCEPT
fails to take any preliminary action to the initiation of a suit or otherwise halt infringement or unauthorized use of Joint Patent
Rights in the INTERCEPT Territory within sixty (60) days after becoming aware of any such infringement, in the first instance or
by notice from SERVIER, then SERVIER, at any time prior to INTERCEPT thereafter filing an action for infringement, shall have the
right but not the obligation, at its own expense, to take such action in its own name as it deems necessary or appropriate. INTERCEPT
shall cooperate with SERVIER as is reasonably necessary in any such action brought by SERVIER at no expense to SERVIER. INTERCEPT
may elect to join or intervene in any such action brought by SERVIER in its own name, at the expense of INTERCEPT, and be represented
by its own counsel. If SERVIER brings legal action for patent infringement or to otherwise halt unauthorized use of Joint Patent
Rights, SERVIER shall have the sole right to control litigation, and the right to settle such action with the prior written consent
of INTERCEPT, which consent shall not be unreasonably withheld.

 

		5.3.6	Platform Patents

 

The Parties hereby agree and
acknowledge that, notwithstanding the provisions of this Article 5.3, a Party shall not have the right to bring a suit or other
action against a Third Party for infringement or unauthorized use of any Platform Patent (as defined below) owned or Controlled
by the other Party to the extent that the Party owning or Controlling such Platform Patent determines (in its sole discretion)
that taking action against a Third Party would put such Platform Patent at risk of being rendered invalid or unenforceable in connection
with such suit or other action. As used herein, the term “Platform Patent” means a patent that claims a technology
that is used in a Product and which is also used in another product, including, for example, a patented formulation technology.

 

		5.3.7	Recovery

 

In the event any monetary
recovery is obtained in connection with any action taken pursuant to Article 5.3.4 or 5.3.5, such recovery shall be applied in
the following priority: first, to reimburse INTERCEPT and SERVIER by the proportion and up to the extent of their out-of-pocket
expenses (including reasonable attorneys’ fees: meaning fees which are customary in the respective legal market and which
may exceed the reimbursable fees according to applicable national civil procedure law) in prosecuting such action; and second,
any amounts remaining (if any) shall be allocated [***] percent ([***]%) to the Party initiating the legal action and [***] percent
([***]%) to the other Party, if the other Party provides material assistance, as determined using reasonable commercial standards,
and if not then, [***] ([***]%) to the initiating Party.

 

		5.3.8	Alleged infringement by Third Party Patentee rights Against
SERVIER and/or INTERCEPT.

 

Each of the Parties will notify
the other promptly in writing in the event that it becomes aware of or suspects any claim, threat of, or suit for infringement
by any Third Party directed against the manufacture, packaging, use, sale, offer to sell or import of Product in SERVIER Territory.
The Parties will support each other with advice or any statements or documents to support the defense of any such claims or suits.

 

    	page 36 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

		5.4	Trademarks

 

		5.4.1	Ownership

 

SERVIER
shall at its own expense select, register and maintain the trademark(s) used by SERVIER, its Affiliates, and its sublicensees (the
“SERVIER Trademarks”) in connection with Products in SERVIER Territory. INTERCEPT
shall have no rights in respect of SERVIER Trademarks but shall receive notice of all such trademarks.

 

INTERCEPT
shall at its own expense select, register and maintain the trademark(s) used by INTERCEPT, its Affiliates and sublicensees (the
“INTERCEPT Trademarks”) in connection with Products in the INTERCEPT Territory.
SERVIER shall have no rights in respect of INTERCEPT Trademarks.

 

		5.4.2	Notice of unauthorized use

 

(a)
INTERCEPT agrees to give SERVIER prompt written notice of any unlicensed use by Third Parties of SERVIER Trademarks of which INTERCEPT
has knowledge.

 

(b)
SERVIER agrees to give INTERCEPT prompt written notice of any unlicensed use by Third Parties of INTERCEPT Trademarks of which
SERVIER has knowledge.

 

Article
6: CONFIDENTIALITY

 

		6.1	Confidentiality; Exceptions

 

Except as otherwise provided
in this Agreement, the Parties agree that, during the Term and for seven (7) years thereafter, all non-public, proprietary invention
disclosures, know-how, data, and technical, financial, promotional, commercial and other information of any nature whatsoever (collectively,
“Confidential Information”), disclosed or submitted, either orally or in writing (including, without limitation
by electronic means) or through observation, by one Party (the “Disclosing Party”) to the other Party (the “Receiving
Party”) hereunder shall be received and maintained by the Receiving Party in strict confidence, shall not be used for
any purpose or disclosed to any Third Party other than the purposes expressly permitted by this Agreement, (including, without
limitation in connection with any publications, presentations or other disclosures). Notwithstanding the foregoing, the Receiving
Party may, subject to the provisions of this Agreement, disclose the Disclosing Party’s Confidential Information to those
of its and its Affiliates’ or its sublicensees’ directors, officers, employees, agents, consultants, contractors and
clinical investigators that have a need to know such Confidential Information to achieve the purposes of this Agreement; provided,
however, that such Party shall ensure that its and its Affiliates’ or sublicensees’ directors, officers, employees,
agents, consultants, contractors or clinical investigators to whom disclosure is to be made are bound by, and take reasonable efforts
to ensure compliance with, the confidentiality and use provisions at least as restrictive as those contained in this Article 6
hereof. Each Party will promptly notify the other upon discovery of any unauthorized use or disclosure of the Disclosing Party’s
Confidential Information. Confidential Information belongs to and shall remain the property of the Disclosing Party.

 

    	page 37 of 67
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The provisions of this Article
6 shall not apply to any information that can be shown by the Receiving Party:

 

To have
been known to or in the possession of the Receiving Party and at its free disposal prior to the date of its actual receipt from
the Disclosing Party;

 

To be or
to have become readily available to the public other than through any act or omission of the Receiving Party in breach of this
Agreement or any other agreement between the Parties;

 

To have
been disclosed to the Receiving Party, other than under an obligation of confidentiality, by a Third Party which had no obligation
to the Disclosing Party not to disclose such information to others; or

 

To have
been subsequently independently developed by the Receiving Party without use of the Confidential Information as demonstrated by
competent written records.

 

For this
article 6 only, INTERCEPT Know-How shall be deemed to be Confidential Information pertaining to both Parties, with both Parties
being obliged to keep it confidential.

 

		6.2	Authorized Disclosure

 

A Receiving Party may disclose
Confidential Information of a Disclosing Party hereunder solely to the extent such disclosure is reasonably necessary in connection
with submissions to or any requirements of any Regulatory Authority for the purposes of this Agreement or, complying with applicable
laws or the rules of any relevant stock exchange or securities commission; provided that in the event of any such disclosure of
the Disclosing Party’s Confidential Information by the Receiving Party, the Receiving Party will, except where impracticable,
give reasonable advance notice to the Disclosing Party of such disclosure requirement (so that the Disclosing Party may seek a
protective order and or other appropriate remedy or waive compliance with the confidentiality provisions of this Article 6) and
will use Commercially Reasonable Efforts to secure confidential treatment of such Confidential Information required to be disclosed.

 

		6.3	Return of Confidential Information

 

The Receiving Party shall keep
Confidential Information belonging to the Disclosing Party in appropriately secured locations. Upon the expiration or termination
of this Agreement, subject to any surviving right of a Party to continue to make use of the other Party’s Confidential Information,
any and all Confidential Information possessed in tangible form by a Receiving Party, its Affiliates or sublicensees, or its or
any of their officers, directors, employees, agents, consultants, contractors or clinical investigators and belonging to the Disclosing
Party, shall, upon written request, be immediately returned to the Disclosing Party (or destroyed if so requested) and not retained
by the Receiving Party, its Affiliates or sublicensees, or any of their officers, directors, employees, agents, consultants, contractors
or clinical investigators; provided, however, that the Receiving Party, its Affiliates or Sublicenses may retain one (1) copy of
any Confidential Information in an appropriately secured location, in order to demonstrate compliance with the terms of this Agreement
or which by applicable laws it must retain, for so long as such applicable laws require such retention but thereafter shall dispose
of such retained Confidential Information in accordance with applicable laws or this Article 6.3.

 

    	page 38 of 67
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		6.4	Publications and Announcements

 

The Receiving Party agrees not
to publish any Confidential Information of the Disclosing Party without the latter’s consent, and each Party agrees not to
publish any information related to an Invention not already protected by a Patent Rights without the consent of the other Party.
At least thirty (30) days prior to any such publication or presentation, the Party proposing to publish or present any Invention
or Confidential Information shall provide the other Party with a copy of the proposed abstract, manuscript or presentation (including,
without limitation information to be presented verbally) for review. The other Party shall respond in writing within such time
period with either approval of the proposed material or a specific statement of (a) concern based upon the need to seek patent
protection, (b) concern regarding competitive disadvantage arising from the proposal, or (c) concern regarding the timing and circumstances
of such disclosure in light of such Party’s business. In the event that the other Party has concerns about the disclosure
of Inventions or Confidential Information, the Party proposing to publish agrees to provide such other Party with any additional
information relating to the proposed disclosure, as reasonably requested by such other Party. In the event of concern relating
to patent protection, the Party proposing to publish agrees not to submit such abstract or manuscript for publication or to make
such presentation until the other Party has had a reasonable period of time to seek patent protection for any material in such
publication or presentation which it believes is patentable or to resolve any other issues, such period not to exceed six (6) additional
months. In the event of concern regarding competitive disadvantage or the timing and other circumstances relevant to the disclosure,
the Parties will negotiate in good faith to attempt to arrive at a compromise to permit the Party proposing to publish an opportunity
to publish or present the disclosure within a reasonable period of time. The Party proposing to publish also agrees to delete from
any such abstract or manuscript or presentation any Confidential Information of the other Party that such other Party reasonably
believes has commercial value based upon the secrecy of such information. Once approval for a publication or presentation has been
granted, the relevant Party shall be entitled to use information contained in such publication or presentation after the date of
its publication or presentation without seeking further approval. It is understood that general comments made by a Party relating
to the relationship between SERVIER and INTERCEPT established by this Agreement, including, for example, general comments made
in response to inquiries at professional meetings and other similar circumstances, are not intended to be restricted by the provisions
of this Article 6 provided that such information has been disclosed to the public previously or cleared for such disclosure by
the other Party.

 

    	page 39 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

Article
7: REPRESENTATIONS, WARRANTIES AND COVENANTS

 

		7.1	Representations and Warranties of the Parties Concerning
Corporate Authorizations

 

Each Party represents and warrants
to the other Party that:

 

Such Party
is duly organized and validly existing and in good standing under the laws of the jurisdiction of its organization;

 

Such Party
has the full corporate power and is duly authorized to enter into, execute and deliver this Agreement, and to carry out and otherwise
perform its obligations thereunder; and

 

This Agreement
has been duly executed and delivered by, and is the legal and valid obligations binding upon such Party and so far as it is aware,
the entry into, the execution and delivery of, and the carrying out and other performance of its obligations under this Agreement
by such Party (i) does not conflict with, or contravene or constitute any default under, any agreement, instrument or understanding,
oral or written, to which it is a party, including, without limitation its certificate of incorporation or by-laws, and (ii) does
not violate applicable laws or any judgment, injunction, order or decree of any Regulatory Authority having jurisdiction over it.

 

		7.2	Representations, Warranties and Covenants of INTERCEPT

 

INTERCEPT represents and warrants
to SERVIER that:

 

As of
the Effective Date, INTERCEPT Controls the INTERCEPT Patent Rights and INTERCEPT Know-How;

 

INTERCEPT
shall have access (through ownership, out-sourcing, contracting or otherwise) throughout the Term of this Agreement to a work force
suitably qualified and trained, and facilities and equipment sufficient, to enable INTERCEPT to perform its obligations as set
forth from time to time under this Agreement;

 

There
are not as of the Effective Date, nor have there been over the six (6) months period immediately preceding the Effective Date,
any claims, lawsuits, arbitrations, legal or administrative or regulatory proceedings, charges, complaints or investigations by
any Regulatory Authority (except in the ordinary course of the granting of patents and proceedings relating thereto) or other third
party against INTERCEPT or, to INTERCEPT’ knowledge, its licensor(s), and INTERCEPT, and to INTERCEPT’ knowledge, its
licensor(s), have not received any notice of infringement with respect to the use or exploitation of INTERCEPT Patent Rights and
INTERCEPT Know-How;

 

    	page 40 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

INTERCEPT
has not been debarred by the FDA under the Generic Drug Enforcement Act of 1992 (or by any analogous agency or under any analogous
law or regulation), and neither it nor, to its knowledge, any of its officers or directors has ever been convicted of a felony
under the laws of the USA and/or European Union for conduct relating to the development or approval of a drug product or relating
to the marketing or sale of a drug product, and further, to its knowledge, no individual or firm debarred by any governmental authority
will participate in the performance, supervision, management or review of the production of licensed Compounds or Products;

 

As of
the Effective Date, INTERCEPT has not granted rights to any Third Party under the INTERCEPT Patent Rights and INTERCEPT Know-How
that are inconsistent with the rights granted to SERVIER under this Agreement.

 

		7.3	Representations, Warranties and Covenants of SERVIER

 

SERVIER
warrants and represents to INTERCEPT that:

 

As of the Effective
Date, SERVIER Controls SERVIER Patent Rights and SERVIER Know-How;

 

SERVIER shall
have access (through ownership, out-sourcing, contracting or otherwise) throughout the Term of this Agreement to a work force suitably
qualified and trained, and facilities and equipment sufficient, to enable SERVIER to perform its obligations as set forth from
time to time under this Agreement;

 

SERVIER has
not been debarred by any Regulatory Authority in the SERVIER Territory or the FDA under the Generic Drug Enforcement Act of 1992
(or by any analogous agency or under any analogous law or regulation), and neither it nor, to its knowledge, any of its officers
or directors has ever been convicted of a felony under the laws of the USA and/or European Union for conduct relating to the development
or approval of a drug product or relating to the marketing or sale of a drug product, and further, to its knowledge, no individual
or firm debarred by any governmental authority will participate in the performance, supervision, management or review of the production
of licensed Compounds or Products.

 

As of the Effective
Date, SERVIER has not granted rights to any Third Party under SERVIER Patent Rights and SERVIER Know-How that are inconsistent
with the rights granted to INTERCEPT under this Agreement.

 

    	page 41 of 67
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		7.4	Negative covenants

 

		(a)	Other than for the conduct of its activities under the terms of this Agreement, each Party agrees
that, during the Research Program Term, it shall not, itself or through one or more Affiliates or third parties, research or non-clinically
develop any chemical entity and/or active ingredient which is a selective or non-selective TGR5 receptor agonist.

 

		(b)	Other than for the conduct of its activities under the terms of this Agreement, each Party agrees
that, during the Term, it shall not, itself or through one or more Affiliates or third parties, including but not limited to licensees,
sell, offer for sale, distribute, promote or market in the Field, in the other Party’s territory, any chemical entity and/or
active ingredient which is a selective or non-selective TGR5 receptor agonist.

 

The above
mentioned obligations shall not apply to INTERCEPT with respect to the following compounds: INT-777; INT-747 and INT-767 as defined
in exhibit B.

 

		7.5	Disclaimer

 

Each of
the Parties agrees that the representations and warranties of the other Party contained in this Agreement are the exclusive representations
and warranties made by the other Party in connection with this Agreement and that such representations and warranties are in lieu
of all other representations and warranties express or implied all of which are hereby expressly excluded and disclaimed.

 

Article
8: INDEMNIFICATION, INSURANCE AND LIMITATION OF LIABILITY

 

		8.1	Indemnification by SERVIER

 

SERVIER hereby agrees to save,
defend, and hold INTERCEPT, its Affiliates and their officers, directors, employees and agents harmless from and against any and
all direct and foreseeable losses, damages, liabilities, costs and expenses resulting from any claims, demands, actions and other
proceedings by any Third Party (collectively, “Losses”) to the extent resulting directly from or arising directly
out of: (a) any material breach by SERVIER of any representation, warranty, covenant under this Agreement or (b) the gross negligence
or willful misconduct of SERVIER or its Affiliates or sublicensees, and its or their directors, officers, agents, employees or
consultants, or (c) the unauthorized use by SERVIER in SERVIER Territory of INTERCEPT Data and Regulatory Documents.

 

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		8.2	Indemnification by INTERCEPT

 

INTERCEPT hereby agrees to save,
defend and hold SERVIER, its Affiliates and their officers, directors, employees and agents harmless from and against any and all
direct and foreseeable losses, damages, liabilities, costs and expenses resulting from any claims, demands, actions and other proceedings
by any Third Party (collectively, “Losses”) to the extent resulting directly from or arising directly out of:
(a) any material breach by INTERCEPT of any representation, warranty, covenant under this Agreement or (b) the gross negligence
or willful misconduct of INTERCEPT, or its Affiliates or sublicensees and its or their directors, officers, agents, employees or
consultants, or (c) the unauthorized use by INTERCEPT in the INTERCEPT Territory of SERVIER Data and Regulatory Documents.

 

		8.3	Control of Defense

 

In the event
a Party seeks indemnification under Article 8.1 or Article 8.2, it shall inform the other Party (the “Indemnifying Party”)
of a claim as soon as reasonably practicable after it receives notice of the claim, 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 and
with an unconditional release of claims against the indemnitee), and shall cooperate as requested (at the expense of the Indemnifying
Party) in the defense of the claim. The indemnitee shall be entitled to participate, at its own expense and with its own counsel,
in the defense of any indemnified claim. The Indemnifying Party shall not settle or compromise any such matter in any manner which
could have an adverse effect upon the indemnitee without such indemnitee’s consent, which shall not be unreasonably withheld
or delayed. In addition, if the Indemnifying Party believes that it is not obligated to provide indemnity as to a matter as to
which it is requested to do so by an indemnitee and promptly so notifies the indemnitee, the indemnitee may either take action
to enforce its rights hereunder or assume the defense of such claim with its own counsel at its own expense, provided that the
Indemnifying Party will be responsible for the payment of such expenses if it is ultimately determined such indemnitee was entitled
to indemnification hereby.

 

		8.4	Mitigation

 

For the avoidance
of doubt no Party shall recover from the other Party more than once for a single cause of action under an indemnity granted by
an Indemnifying Party pursuant to this Agreement or recover if or to the extent the indemnitee has been relieved by or recovered
from any third party. Each Party shall take and shall cause its Affiliates to take all reasonable steps to mitigate any Losses
upon becoming aware of any event which would reasonably be expected to, or does, give rise thereto, including incurring costs only
to the minimum extent necessary to remedy a breach that gives rise to the Losses.

 

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		8.5	Insurance

 

Each Party shall obtain and maintain,
for so long as a Party can be liable to the other Party under this Agreement, commercial general liability insurance (including
product liability and contractual liability insurance applicable to such Party’s indemnity obligations hereunder) with reputable
and financially secure insurance carriers to cover the activities of such Party, its sublicensees, and their Affiliates, in amounts
reasonably sufficient to protect against liability under this section 8 and in no event below $4,000,000 USD during the Research
Program Term, and $10,000,000 USD if INTERCEPT conducts any Clinical Trials with a Compound or a Product in INTERCEPT Territory
after Research Program Term. An insurance certificate shall be provided by one Party to the other Party upon request of the latter
at any time during the Term.

 

		8.6	Limitation of liability

 

EXCEPT FOR
GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, UNDER NO CIRCUMSTANCES SHALL A PARTY HEREOF BE LIABLE TO THE OTHER PARTY HEREOF FOR PUNITIVE
OR INDIRECT DAMAGES. LOSS OF PROFITS SHALL BE DEEMED TO CONSTITUTE INDIRECT DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN
THIS ARTICLE 8.6 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER ARTICLE
8.1 AND ARTICLE 8.2.

 

Article
9: TERM AND TERMINATION

 

		9.1	Term

 

9.1.1This
Agreement shall commence on the Effective Date and shall expire on the date when no payment obligations under this Agreement are
or will become due (the “Term”).

 

		9.1.2	Notwithstanding the provisions of Article 9.1.1 above, this Agreement may be terminated, on a country-by-country
or Product by Product basis, or in its entirety, prior to the expiration date in accordance with the terms and conditions of this
Article 9 (Term and Termination) or as expressly set forth in other provisions of this Agreement.

 

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		9.2	Termination for cause

 

If either Party commits a material
breach of this Agreement at any time, which breach is not cured within ninety (90) days, after written notice from the non-breaching
Party specifying the breach, or if such breach is not susceptible of cure within such period, the non-breaching Party shall have
the right to terminate this Agreement, on a country-by-country or Product-by- Product basis, or in its entirety, by written notice.
The Parties acknowledge and agree that failure to exercise any right or option, or to take any action expressly within the discretion
of a Party shall not be deemed to be a material breach hereunder.

 

Notwithstanding the foregoing,
if the alleged breaching Party disputes in good faith the existence or materiality of such breach and provides notice to the non-breaching
Party of such dispute within the applicable cure period, the non-breaching Party shall not have the right to terminate this Agreement
in accordance with this Section 9.2 unless and until it has been determined in accordance with Section 10.2 that this Agreement
was materially breached by the alleged breaching Party and the breaching Party fails to cure such breach within sixty (60) days
following such determination. It is understood and acknowledged that during the pendency of such a dispute, all of the terms and
conditions of this Agreement shall remain in effect and the Parties shall continue to perform all of their respective obligations
hereunder. The Parties further agree that any payments that are made by one Party to the other Party pursuant to this Agreement
pending resolution of the dispute shall be promptly refunded if an arbitrator determines pursuant to Section 10.2 that such payments
are to be refunded by one Party to the other Party.

 

		9.3	Termination for insolvency

 

To the extent permitted by applicable
laws, either Party may terminate this Agreement upon written notice to the other Party on or after the occurrence of any of the
following events: (i) the appointment of a trustee, receiver or custodian for all or substantially all of the property of the other
Party, or for any lesser portion of such property, if the result materially and adversely affects the ability of the other Party
to fulfill its obligations hereunder, which appointment is not dismissed within sixty (60) days, (ii) the determination by a court
or tribunal of competent jurisdiction that the other Party is insolvent, (iii) the filing of a petition for relief in bankruptcy
by the other Party on its own behalf, or the filing of any such petition against the other Party if the proceeding is not dismissed
or withdrawn within sixty (60) days thereafter, (iv) an assignment by the other Party for the benefit of creditors, or (v) the
dissolution or liquidation of the other Party. All rights and licenses granted under or pursuant to this Agreement by one Party
to the other Party are, and shall otherwise be deemed to be, licenses of rights to “intellectual property”. The Parties
agree that both Parties, as licensees of such rights and licenses, shall retain and may fully exercise all of their rights and
elections under the applicable bankruptcy laws.

 

    	page 45 of 67
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		9.4	Termination by SERVIER Without Cause OR due to INTERCEPT
Change of Control

 

SERVIER shall be permitted to
terminate the Agreement in its entirety without cause or because of a INTERCEPT Change of Control, at no costs to SERVIER, upon
ninety (90) days prior written notice to INTERCEPT.

 

		9.5	Effects of certain Termination

 

		9.5.1	Effects of termination by SERVIER on the basis of
article 9.2 or of article 9.3:

 

The consequences
of the termination of the Agreement by SERVIER on the basis of article 9.2 (“Termination for Cause”), or article 9.3
(“Termination for Insolvency”) are as follows: prior to or within thirty days following such a termination, SERVIER
shall, by written notice to INTERCEPT, either opt for the consequences set forth in Section 9.5.1.1, or opt for the consequences
set forth in Section 9.5.1.2 (the latter being only possible in case of termination of the Agreement in its entirety) below:

 

9.5.1.1
If SERVIER elects to terminate the Agreement with the consequences set forth in this Section 9.5.1.1, then SERVIER retains the
right to pursue any and all remedies (including damages) that are available to SERVIER arising out of a breach of this Agreement
by INTERCEPT (if applicable).

 

9.5.1.2
If SERVIER opts for the consequences set forth in this Section 9.5.1.2, then the following rights and obligations shall become
operative at the effective date of termination:

 

(a) Modification
of licenses granted by INTERCEPT. The licenses granted to SERVIER under article 3.1. shall be revised such that SERVIER shall have
an irrevocable, perpetual, fully paid-up, royalty-free exclusive license, which includes the right to sublicense, under INTERCEPT
Technology to research, develop, make, have made, use, promote, market, sell, offer for sale, import, export and otherwise commercialize
the Compounds and Products in the Field in and/or for the SERVIER Territory. Under such circumstances INTERCEPT shall transfer
to SERVIER all Data, take any action and sign any document which SERVIER may reasonably request in order to ensure the effectiveness
of the license.

 

(b) INTERCEPT
shall reimburse to SERVIER the Refundable Amount (or the equivalent for Japan) as set forth in Article 2.2.3 if such Refundable
Amount is due, such reimbursement to be paid within 90 days from the determination that reimbursement to Servier is due hereunder.

 

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(c) INTERCEPT
shall maintain its pre-existing IP rights for use within the US and Japan.

 

(d) INTERCEPT
shall be subject to the negative covenant set forth in Section 7.4 (b) for a period of 12 months after termination of this Agreement.

 

(e) SERVIER
retains the right to pursue any and all remedies (including damages) that are available to SERVIER arising out of a breach of
this Agreement by INTERCEPT (if applicable).

 

(f) INTERCEPT
shall retain in entirety its INTERCEPT Patent Rights.

 

9.5.2           Effects
of termination by INTERCEPT on the basis of article 9.2 or of article 9.3:

 

The consequences
of the termination of the Agreement by INTERCEPT on the basis of article 9.2 (“Termination for Cause”), or article
9.3 (“Termination for Insolvency”) are as follows: prior to or within thirty days following such a termination, INTERCEPT
shall, by written notice to SERVIER, either opt for the consequences set forth in Section 9.5.2.1, or opt for the consequences
set forth in Section 9.5.2.2 (the latter being only possible in case of termination of the Agreement in its entirety) below:

 

			9.5.2.1 If INTERCEPT elects to terminate
                                                    the Agreement with the consequences set forth in this Section 9.5.2.1, then
                                                    INTERCEPT retains the right to pursue any and all remedies (including damages)
                                                    that are available to INTERCEPT arising out of a breach of this Agreement
                                                    by SERVIER (if applicable).

 

			9.5.2.2 If INTERCEPT opts
                                                                for the consequences set forth in this Section 9.5.2.2, then the
                                                                following rights and obligations shall become operative at the
                                                                effective date of termination:

 

(a) The licenses
granted to INTERCEPT under article 3.1. shall be revised such that INTERCEPT shall have an irrevocable, perpetual, fully paid-up,
royalty-free exclusive license, which includes the right to sublicense, under SERVIER Technology to research, develop, make, have
made, use, promote, market, sell, offer for sale, import, export and otherwise commercialize the Compounds and Products in the
Field in and/or for the INTERCEPT Territory. Under such circumstances SERVIER shall transfer to INTERCEPT all Data, take any action
and sign any document which INTERCEPT may reasonably request in order to ensure the effectiveness of the license.

 

(b) SERVIER
shall be subject to the negative covenant set forth in Section 7.4 (b) for a period of 12 months after termination of this Agreement.

 

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(c) INTERCEPT
shall maintain its INTERCEPT Know How and INTERCEPT Patent Rights for use within the SERVIER and INTERCEPT Territory and
in the INTERCEPT Territory.

 

(d) INTERCEPT
shall have no further obligation to reimburse to SERVIER the Refundable Amount (or the equivalent for Japan) as set forth in Article
2.2.3.

 

(e) INTERCEPT
retains the right to pursue any and all remedies (including damages) that are available to INTERCEPT arising out of a breach of
this Agreement by SERVIER (if applicable).

 

9.5.3           Effects
of termination by SERVIER without cause:

 

The consequences
of the termination of the Agreement by SERVIER without cause, are as follows:

 

(a) Upon
INTERCEPT written request, SERVIER shall assign to INTERCEPT, free of charge, SERVIER’s rights in Joint Patent Rights and
in Joint Know-How.

 

(b) SERVIER
shall promptly provide to INTERCEPT a copy of all Data pertaining to the Compounds and the Products. Should such Data be used
by INTERCEPT, its Affiliates or its licensees in a filing for submission of Regulatory Approval then, upon such use of the Data,
INTERCEPT shall reimburse to SERVIER [***]% of the Development Costs.

 

(c) Subject
to subsection (b) above, INTERCEPT shall have no further obligation to reimburse to SERVIER the Refundable Amount (or the equivalent
for Japan) as set forth in Article 2.2.3.

 

(d) SERVIER
shall be subject to the negative covenant set forth in Section 7.4 (b) for a period of 18 months after termination of this Agreement.

 

(e) INTERCEPT
shall maintain its INTERCEPT Know How and INTERCEPT Patent Rights for use within the SERVIER Territory and in the INTERCEPT
Territory.

 

(f) Should
such termination without cause (i.e. not due to INTERCEPT change of control) occur during the Research Program Term, SERVIER shall
pay INTERCEPT the balance of the Research Program funding that would otherwise be due over the course of the completed term.

 

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9.6           Survival

 

Termination, relinquishment
or expiration of this Agreement for any reason shall be without prejudice to any right or obligation which shall have accrued
prior to such termination, relinquishment or expiration, including but not limited to accrued financial rights and obligations.
The articles of this Agreement intended to survive termination, and at least the following Articles, shall survive expiration
or termination of this Agreement for any reason:pharmacovigilance 2.9; records and audit 4.6; ownership 5.1.2; confidentiality
6 in its entirety; representations and warranties 7.1, 7.2 and 7.3; disclaimer 7.5; indemnification, insurance and liability 8;
effects of termination 9.5, governing law and dispute resolution 10 in its entirety.

 

9.7
Grant Back

 

At the end of the Research Program,
all rights licensed to SERVIER by INTERCEPT in relation to any Product not selected by SERVIER for preclinical regulatory development
will revert to INTERCEPT, provided however that INTERCEPT shall not be entitled to commercialize, directly or through a licensee,
such Product in the SERVIER Territory in the Field.

 

The same shall apply at the
end of the Research Program to any Product selected by SERVIER for preclinical regulatory development if SERVIER fails to develop
such Product which shall be deemed to be the case if no action is taken by SERVIER for the development of such Product for a consecutive
period of 12 months unless SERVIER can provide good faith reasons for such inactivity.

 

Article
10: GOVERNING LAW AND DISPUTE RESOLUTION

 

10.1         Governing
law

 

This Agreement shall be governed
by and construed under the laws of Switzerland, without giving effect to the conflict of law principles thereof.

 

10.2         Dispute
resolution

 

If the
Parties are unable to resolve any dispute arising out of or in connection with the Parties’ respective rights and responsibilities
under this Agreement, then either SERVIER or INTERCEPT by written notice to the other, may have such dispute referred to their
Responsible Executives, one from each of the Parties, designated to resolve such a dispute by good faith negotiations. In the
event the Responsible Executives are not able to resolve any such dispute within thirty (30) days after receipt of written notice
submitting the dispute to such Responsible Executives, such dispute may be submitted by either Party to arbitration. Any such
arbitration shall be governed by and finally settled under the Rules of Arbitration of the International Chamber of Commerce by
one or three arbitrators appointed in accordance with the said Rules. The arbitration proceedings shall take place in Geneva,
Switzerland in the English language.

 

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All negotiations
conducted by the Parties pursuant to this Article 10.2 shall be deemed to be and shall be treated as compromise and settlement
negotiations. Nothing said or disclosed, nor any document produced, in the course of such negotiations which is not otherwise
independently discoverable shall be offered or received as evidence or used for impeachment or for any other purpose in any current
or future arbitration or litigation.

 

Either
Party may apply to the arbitrators for interim injunctive relief until the arbitration award is rendered or the controversy is
otherwise resolved. Either Party also may, without waiving any remedy under this Agreement, seek from any court having jurisdiction
any injunctive or provisional relief necessary to protect the rights or property of that Party pending the arbitration award.
Each Party shall bear its own attorney’s fees. The arbitrators’ fees and any administrative fees of arbitration shall
be shared equally by the Parties unless otherwise decided by the arbitrators.

 

Article
11: GENERAL PROVISIONS

 

11.1         Assignment,
Subcontracting, No Third Party Rights, Binding Agreement

 

11.1.1
Assignment

 

Neither Party
may assign or otherwise transfer its rights or obligations under this Agreement without the prior written consent of the other
Party, such consent not to be unreasonably withheld, except that a Party may assign or otherwise transfer its rights and obligations
in whole or in part without such consent (i) to an Affiliate of such Party, or (ii) to a third party solely in connection with
the merger, consolidation, or sale of substantially all of the assets of the assigning Party relating to this Agreement, or reorganization
affecting substantially all of the assets of a Party relating to this Agreement or voting control of the assigning Party.

 

11.1.2 Subcontracting

 

Each Party shall be entitled
to sub-contract to Third Parties the performance of any of its rights and obligations as per the Agreement without the other Party’s
consent. However, each Party will require its Affiliates, sublicensees, agents or independent contractors performing an activity
pursuant to this Agreement to assign to such Party all Inventions that are developed, made or conceived by such agents or independent
contractors in the course of performing such activity.

 

11.1.3 No Third Party
Rights

 

The representations, warranties,
covenants and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted
assigns and a person who is not a Party to this Agreement may not enforce any of its terms unless otherwise provided.

 

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11.1.4 Binding Agreement

 

This Agreement shall be binding
upon and inure to the benefit of the successors and permitted assigns of the Parties. Any assignment not in accordance with this
Agreement shall be null and void.

 

11.2         Force
majeure

 

Neither Party shall be liable
to the other Party for damages or losses on account of failure of performance by the defaulting Party to the extent the failure
is occasioned by regulatory action, war, fire, explosion, flood, strike, lockout, embargo, act of God, or any other similar cause
beyond the reasonable control of the defaulting Party. The Party claiming force majeure shall as soon as reasonably practicable
notify the other Party in writing setting forth the nature of such force majeure event, and shall use reasonable efforts to resume
performance of its obligations hereunder as soon as reasonably practicable after such force majeure event ceases. If any force
majeure event continues for more than one hundred eighty (180) days, and such event prevents a Party from performing a material
obligation under this Agreement, then the other Party may terminate this Agreement upon written notice to the affected Party.

 

11.3         Further
Actions

 

Each Party agrees to execute,
acknowledge and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate in order to
carry out the purposes and intent of this Agreement.

 

11.4         Regulatory
Approvals; Compliance with Law

 

The Parties shall make all
filings with Regulatory Authorities as shall be required by applicable laws in connection with this Agreement and the activities
contemplated hereunder or thereunder. In fulfilling its obligations under this Agreement each Party agrees to comply in all material
respects with all applicable laws.

 

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11.5         Public
Announcement

 

Except for such disclosure
as is deemed necessary, in the reasonable judgment of a Party to comply with applicable laws, no announcement, news release, public
statement, publication or presentation relating to the existence of this Agreement, or the terms hereof or thereof, will be made
without the other Party’s prior written approval, which approval shall not be unreasonably withheld. Notwithstanding the
foregoing, each Party consents to references to it in reports or documents or other disclosures sent to stockholders or filed
with or submitted to any Regulatory Authority or stock exchange or as may be required by law to be made. However, the Party making
such references shall afford the other Party the prior opportunity to review the text of any such report, document or other disclosure,
and shall use its best efforts to comply with any reasonable requests regarding changes to such reports, documents and other disclosures
which are provided to it by the other Party in a timely manner. The Parties each agree that once approval for disclosure of information
subject to this Article has been obtained, the Party that requested such approval shall be entitled to use such information substantially
in the form initially presented without an obligation to seek further approval.

 

11.6         Notices

 

All notices required or permitted
to be given under this Agreement, including, without limitation all invoices provided by INTERCEPT to SERVIER, shall be in writing
and shall be deemed given if delivered personally or by facsimile transmission receipt verified, mailed by registered or certified
mail return receipt requested, postage prepaid, or sent by express courier service, to the Parties at the following addresses,
or at such other address for a Party as shall be specified by like notice, provided that notices of a change of address shall
be effective only upon receipt thereof.

 

If to INTERCEPT,
addressed to:

 

INTERCEPT PHARMACEUTICALS, INC.

18 Desbrosses Street

New York, NY 10013

Attention:
Dr. Mark Pruzanski, Chief Executive Officer

 

If to SERVIER,
addressed to:

 

INSTITUT
DE RECHERCHES SERVIER

3 rue de la
République

92150 Suresnes

France

 

Attention:
Head of Research

Facsimile:
+ 33 1 55 72 26 40

 

With copies,
except

for invoices,
to:

Les Laboratoires
Servier

Legal Department

22 Rue Garnier

92578 Neuilly
sur Seine cedex

France 

 

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The date of receipt of any
notice given under this Agreement shall be deemed to be (i) the date given if delivered personally or by facsimile transmission
receipt verified, (ii) seven (7) days after the date mailed if mailed by registered or certified mail return receipt requested,
postage prepaid, and (iii) two (2) days after the date sent if sent by express courier service.

 

11.7         Waiver

 

No failure of either Party
to exercise and no delay in exercising any right, power or remedy in connection with this Agreement (each a “Right”)
will operate as a waiver thereof, nor will any single or partial exercise of any Right preclude any other or further exercise
of such Right or the exercise of any other Right.

 

11.8         Disclaimer
of Agency

 

The relationship between INTERCEPT
and SERVIER established by this Agreement is that of independent contractors, and nothing contained herein shall be construed
to (i) give either Party the power to direct or control the day-to-day activities of the other, (ii) constitute the Parties as
the legal representative or agent of the other Party or as partners, joint venturers, co-owners or otherwise as participants in
a joint or common undertaking, or (iii) allow either Party to create or assume any liability or obligation of any kind, express
or implied, against or in the name of or on behalf of the other Party for any purpose whatsoever, except as expressly set forth
in this Agreement.

 

11.9         Ambiguities

 

Ambiguities, if any, in this
Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.

 

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11.10         Headings
and Article References

 

The Article headings and references
contained herein are for the purposes of convenience only and are not intended to define or limit the contents of said Articles,
except that any conflict between an Article reference number and any textual reference to the Article title noted next to such
reference, will resolved in favor of the textual reference.

 

11.11         Severability

 

If any term, covenant or condition
of this Agreement or the application thereof to any Party or circumstance shall, to any extent, be held to be invalid or unenforceable
by a court or administrative agency of competent jurisdiction, then (i) the remainder of such documents, or the application of
such term, covenant or condition to Parties or circumstances other than those as to which it is held invalid or unenforceable,
shall not be affected thereby and each term, covenant or condition of such documents shall be valid and be enforced to the fullest
extent permitted by law; and (ii) the Parties hereto covenant and agree to renegotiate any such term, covenant or application
thereof in good faith in order to provide a reasonably acceptable alternative to the term, covenant or condition of such documents
or the application thereof that is invalid or unenforceable, it being the intent of the Parties that the basic purposes of this
Agreement are to be effectuated.

 

11.12         Entire
Agreement

 

This Agreement, including
all schedules and exhibits attached hereto, which are hereby incorporated herein by reference, sets forth all covenants, promises,
agreements, warranties, representations, conditions and understandings between the Parties hereto and supersedes and terminates
all prior and contemporaneous agreements and understandings between the Parties with respect to the subject matter hereof. There
are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between
the Parties other than as set forth herein. No subsequent alteration, amendment, change or addition to this Agreement shall be
binding upon the Parties hereto unless reduced to writing and signed by the respective authorized officers of the Parties.

 

11.13         Counterparts

 

This Agreement may be executed
in counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

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In witness whereof, the Parties
have executed this Agreement by their proper officers as of the date and year first above written.

 

	INTERCEPT PHARMACEUTICALS, INC.	LES LABORATOIRES SERVIER
	 	 
	/s/ Mark Pruzanski	/s/ Christian Bazantay
	Mark PRUZANSKI	Mr Christian BAZANTAY
	 	 
	President and CEO	Proxy
	 	 
	 	/s/ Jean-Philippe Seta
	 	Dr Jean-Philippe SETA
	 	
	 	Proxy
	 	 
	 	INSTITUT DE RECHERCHES SERVIER
	 	 
	 	/s/ Emmanuel Canet
	 	Dr Emmanuel CANET
	 	 
	 	President R&D

 

    page 55 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.	 

    	 	

    

EXHIBIT A 

RESEARCH PROGRAM

 

Servier- Intercept Research Plan

 

[***]

 

Exhibit A pg. 1 of 11

 

    	page 56 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

[***]

 

Exhibit A pg. 2 of 11

 

    	page 57 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

[***]

 

Exhibit A pg. 3 of 11

 

    	page 58 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

[***]

 

Exhibit A pg. 4 of 11

 

    	page 59 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

[***]

 

Exhibit A pg. 5 of 11

 

    	page 60 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

[***]

 

Exhibit A pg. 6 of 11

 

    	page 61 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

[***]

 

Exhibit A pg. 7 of 11

 

    	page 62 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

[***]

 

Exhibit A pg. 8 of 11

 

    	page 63 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

[***]

 

Exhibit A pg. 9 of 11

 

    	page 64 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

[***]

 

Exhibit A pg. 10 of 11

 

    	page 65 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

[***]

 

Exhibit A pg. 11 of 11

 

    	page 66 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

    	 

    

 

EXHIBIT B 

INTERCEPT COMPOUNDS NOT COVERED BY THE
NEGATIVE COVENANT OF

SECTION 7.4

 

The following Compounds, [***],
are excluded from the negative covenant under Section 7.4:

 

 

    	page 67 of 67
Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended.

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