EXHIBIT 10.6

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS
BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM
TO IMMUNOVANT, INC. IF PUBLICLY DISCLOSED.

LICENSE AGREEMENT

THIS LICENSE AGREEMENT (the “Agreement”) is entered into as of December 19th,
2017 (the “Effective Date”), by and between HANALL BIOPHARMA CO., LTD., a Korean
limited liability company (“HanAll”), having an address of 3rd Fl., Bongeunsaro
114-gil 12, Gangnam-gu, Seoul, Korea, and ROIVANT SCIENCES GMBH., a Swiss
limited liability company (“Roivant”), having an address of Viaduktstrasse 8,
4051 Basel, Switzerland. HanAll and Roivant may be referred to herein
individually as a “Party” or collectively as the “Parties”.

RECITALS

WHEREAS, HanAll is a leading Korean pharmaceutical company that is developing
its proprietary recombinant monoclonal antibody against human neonatal Fc
receptor (hFcRn), referred to as HL161BKN, and owns or controls certain patents,
know-how and data relating to such compound; and

WHEREAS, Roivant desires to obtain from HanAll, and HanAll desires to grant to
Roivant, an exclusive license to develop, register, manufacture and
commercialize products containing HL161BKN and other hFcRn inhibitors in North
America, the European Union, the United Kingdom, Switzerland and Latin America,
all subject to the terms and conditions of this Agreement.

AGREEMENT

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

1. Definitions

1.1 “Affiliate” means, with respect to any party, any entity that, directly or
indirectly through one or more intermediaries, controls, is controlled by or is
under common control with such party, but for only so long as such control
exists. As used in this Section 1.1 (Affiliate), “control” means (a) to possess,
directly or indirectly, the power to direct the management or policies of an
entity, whether through ownership of voting securities, by contract relating to
voting rights or corporate governance, or otherwise; or (b) direct or indirect
beneficial ownership of more than fifty percent (50%) (or such lesser percentage
which is the maximum allowed to be owned by a foreign corporation in a
particular jurisdiction) of the voting share capital or other equity interest in
such entity. Notwithstanding the foregoing, Excluded Affiliates will not be
deemed Affiliates of Roivant for any purpose under this Agreement.

1.2 “Alliance Manager” has the meaning set forth in Section 3.4 (Alliance
Managers).

1.3 “Applicable Laws” means the applicable provisions of any and all national,
supranational, regional, state and local laws, treaties, statutes, rules,
regulations, administrative codes, guidances, ordinances, judgments, decrees,
directives, injunctions, orders, permits (including MAAs) of or from any court,
arbitrator, Regulatory Authority or governmental agency or authority having
jurisdiction over or related to the subject item.

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1.4 “Backup Compound” has the meaning set forth in Section 1.16(b) (Compound).

1.5 “BLA” means a Biologics License Application, as defined in Section 351(a) or
(k) of the Public Health Service Act, 42 U.S.C. Section 262, as amended, and
applicable regulations and guidance promulgated thereunder by the FDA.

1.6 “Business Day” means a day other than a Saturday, Sunday or a bank or other
public holiday in Basel, New York City, or Seoul.

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

1.8 “Calendar Year” means each respective period of twelve (12) consecutive
months ending on December 31.

1.9 “CMC” means chemistry, manufacturing, and controls.

1.10 “CMO” means contract manufacturing organization.

1.11 “Combination Product” means any Licensed Product comprising the following,
either formulated together (i.e., a fixed dose combination) or packaged together
and sold for a single price: (a) a Compound and (b) at least one other active
compound or ingredient.

1.12 “Commercialization” means the conduct of all activities undertaken before
and after Regulatory Approval relating to the promotion, marketing, sale and
distribution (including importing, exporting, transporting, customs clearance,
warehousing, invoicing, handling and delivering Licensed Products to customers)
of Licensed Products in or outside of the Territory, including: (a) sales force
efforts, detailing, advertising, medical education, planning, marketing, sales
force training, and sales and distribution; and (b) scientific and medical
affairs. For clarity, Commercialization does not include any Development
activities, whether conducted before or after Regulatory Approval.
“Commercialize” and “Commercializing” have correlative meanings.

1.13 “Commercialization Plan” has the meaning set forth in Section 4.8
(Commercialization Plan and Report).

1.14 “Commercially Reasonable Efforts” means, with respect to a Party’s
obligations under this Agreement relating to Compounds and Licensed Products,
those efforts and resources that are consistent with the exercise of customary
scientific and business practices, as applied in the pharmaceutical industry for
a company of a similar size and having similar resources, for development,
regulatory, manufacturing and commercialization activities conducted with
respect to products at a similar stage of development or commercialization and
having similar commercial potential, taking into account [*].

 

2.

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1.15 “Competing Product” means [*].

1.16 “Compound” means (a) the recombinant fully human monoclonal antibody with
Fc-engineered IgG1 against hFcRn, referred to by HanAll as HL161BKN, having the
structure set forth on Exhibit A (“HL161BKN”), (b) any antibody that is within
the scope of the claims of PCT patent application number [*] (a “Backup
Compound”), (c) any Next Generation Compound, and (d) any fragment, conjugate,
derivative or modification of any antibody in the foregoing clauses (a), (b) or
(c).

1.17 “Confidential Information” of a Party means all Know-How, materials, and
other proprietary scientific, marketing, financial, or commercial information
that is: (a) disclosed by or on behalf of such Party or any of its Affiliates or
otherwise made available to the other Party or any of its Affiliates, whether
made available orally, in writing, or in electronic form; or (b) learned by the
other Party pursuant to this Agreement. The existence and terms of this
Agreement are the Confidential Information of both Parties. All information
disclosed by a Party under the Confidentiality Agreement that relates to any
Compound or Licensed Product or the transaction under this Agreement is deemed
the Confidential Information of such Party under this Agreement.

1.18 “Confidentiality Agreement” means that certain Mutual Nondisclosure
Agreement between HanAll and Roivant Sciences, Inc., dated February 9, 2017.

1.19 “Control” or “Controlled” means, with respect to any Know-How, materials,
Patents or other intellectual property rights, the legal authority or right
(whether by ownership, license or otherwise but without taking into account any
rights granted by one Party to the other Party pursuant to this Agreement) of a
Party to grant access, a license or a sublicense of or under such Know-How,
materials, Patents or other intellectual property rights to the other Party, or
to otherwise disclose proprietary or trade secret information to such other
Party, without breaching the terms of any agreement with a Third Party, or
misappropriating the proprietary or trade secret information of a Third Party.

1.20 “Data” means any and all scientific, technical and test data pertaining to
any Compound or Licensed Product, including research data, clinical pharmacology
data, CMC data (including analytical and quality control data and stability
data), pre-clinical data, clinical data or submissions made in association with
an IND or MAA with respect to any Compound or Licensed Product, in each case
that is Controlled by a Party.

1.21 “Develop” means to develop (including clinical, non-clinical and CMC
development), analyze, test and conduct preclinical, clinical and all other
regulatory trials for a Compound or Licensed Product, including all
post-approval clinical trials, as well as all related regulatory activities and
any and all activities pertaining to new Indications, pharmacokinetic studies
and all related activities including work on new formulations, new methods of
treatment and CMC activities including new manufacturing methods. “Developing”
and “Development” have correlative meanings.

 

3.

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1.22 “Development Plan” has the meaning set forth in Section 4.2(b) (Development
Plan).

1.23 “Divest” means to sell, exclusively license or transfer all rights to a
Competing Product to a Third Party without receiving a continuing share of
profit, royalty payments, or other economic interest in the success of such
Competing Product in the Territory.

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

1.25 “European Union” or “EU” means the economic, scientific and political
organization of member states known as the European Union, as its membership may
be altered from time to time, and any successor thereto.

1.26 “Excluded Claim” has the meaning set forth in Section 13.3(f)
(Arbitration).

1.27 “Excluded Affiliate” means any entity (a) that directly or indirectly
through one or more intermediaries, controls, is controlled by or is under
common control with Roivant (as “control” is defined in Section 1.1 (Affiliate))
and (b) for which shares are available on a publicly traded stock exchange.
Excluded Affiliates include, as of the Effective Date, Axovant Sciences Ltd. and
Myovant Sciences Ltd.

1.28 “Executive Officers” has the meaning set forth in Section 3.3 (JDC
Decision- Making).

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

1.30 “Field” means all uses in humans and animals.

1.31 “First Commercial Sale” means, on a Licensed Product-by-Licensed Product
and country-by-country basis, the first sale by or on behalf of Roivant or any
of its Affiliates to a Third Party for end use or consumption of a Licensed
Product in a given country in the Territory after Regulatory Approval has been
granted with respect to such Licensed Product in such country.

1.32 “Fiscal Year” means the period from April 1 of a Calendar Year through
March 31 of the following Calendar Year.

1.33 “FTE” means the equivalent of a full time individual’s work for a [*]
period.

1.34 “FTE Rate” means an initial rate per FTE per year as agreed by the Parties
in connection with the approval of the initial detailed Research Plan pursuant
to Section 4.1(a) (Conduct). Commencing [*], the FTE Rate will be revised [*] to
reflect any year-to-year percentage increase or decrease (as the case may be) in
the Consumer Price Index (all items) for South Korea (“CPI”) (based on the
change in the CPI from the most recent index available as of the Effective Date
to the most recent index available as of the date of calculation of such revised
FTE Rate).

 

4.

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1.35 “GAAP” means the generally accepted accounting principles of the applicable
country or jurisdiction, consistently applied, and means the international
financial reporting standards (“IFRS”) at such time as IFRS becomes the
generally accepted accounting standard and Applicable Laws require that a Party
use IFRS.

1.36 “Generic Competition” means, on a Licensed Product-by-Licensed Product and
country-by-country basis, that, in a given Calendar [*], one or more Third
Parties is selling a Generic Product to such Licensed Product in such country
and the unit volume of all Generic Products to such Licensed Product sold in
such country in such [*] exceeds [*] of the combined unit volume of such Generic
Products and such Licensed Product sold in such country in such Calendar [*],
where the number of units of the Generic Products and the Licensed Product sold
in the relevant country and Calendar [*] are as reported by IMS America Ltd. or
any successor thereto and normalized to equivalent units across different
products based on dosage regime (“IMS”) (or based on equivalent data reported by
any other independent sales auditing firm mutually agreed by the Parties if IMS
data are not available).

1.37 “Generic Product” means, with respect to a particular Licensed Product and
country, any product that (a)(i) contains the same compound as the Compound in
such Licensed Product or (ii) is or would otherwise qualify as a biosimilar
version and/or an interchangeable version of the Licensed Product, as the terms
“biosimilar” and “interchangeable” are used in 42 U.S.C. § 262(i)(2)-(3), except
that in either (i) or (ii) said Generic Product may differ from the Licensed
Product in terms of route of administration, dosage form, and strength; (b) is
sold under a marketing authorization granted by a Regulatory Authority in such
country such as the regulatory approval processes described in in 42 U.S.C. §
262, including §§ 262(a) and 262(k), or an equivalent process in any country
outside the U.S., or any other equivalent provision that comes into force, in
each case for an Indication for which such Licensed Product obtained Regulatory
Approval in such country; and (c) is sold in such country by a Third Party that
is not a Sublicensee of Roivant or its Affiliates and did not obtain such
product in a chain of distribution that includes any of Roivant, its Affiliates,
or Sublicensees.

1.38 “Governmental Authority” means any national, international, federal, state,
provincial or local government, or political subdivision thereof, or any
multinational organization or any authority, agency or commission entitled to
exercise any administrative, executive, judicial, legislative, police,
regulatory or taxing authority or power, any court or tribunal (or any
department, bureau or division thereof, or any governmental arbitrator or
arbitral body).

1.39 “HanAll Data” has the meaning set forth in Section 8.1(a) (Data).

1.40 “HanAll Indemnitee” has the meaning set forth in Section 10.2
(Indemnification by Roivant).

1.41 “HanAll Know-How” means all Know-How that HanAll Controls as of the
Effective Date or during the Term that is necessary or reasonably useful for the
Development, manufacture or Commercialization of any Compound or Licensed
Product in the Field in the Territory, including the HanAll Data, HanAll’s Sole
Inventions and HanAll’s interest in Joint Inventions, but excluding all Know-How
licensed to HanAll by a Third Party pursuant to a license agreement executed
after the Effective Date that is not a Third Party License.

 

5.

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1.42 “HanAll Patents” means all Patents in the Territory that HanAll Controls as
of the Effective Date or during the Term that are necessary or reasonably useful
for the Development, manufacture or Commercialization of any Compound or
Licensed Product in the Field in the Territory, including HanAll’s interest in
Joint Patents in the Territory, but excluding all Patents licensed to HanAll by
a Third Party pursuant to a license agreement executed after the Effective Date
that is not a Third Party License. The HanAll Patents existing as of the
Effective Date are listed on Exhibit C.

1.43 “HanAll Technology” means the HanAll Know-How and the HanAll Patents.

1.44 “hFcRn” means the human neonatal Fc receptor.

1.45 “ICH” means the International Conference on Harmonisation (of Technical
Requirements for Registration of Pharmaceuticals for Human Use).

1.46 “IFRS” has the meaning set forth in the definition of “GAAP”.

1.47 “Incremental Withholding Taxes” has the meaning set forth in Section 7.3(b)
(Tax Cooperation).

1.48 “IND” means an Investigational New Drug Application filed with the FDA or
the equivalent application or filing filed with any equivalent agency or
governmental authority outside the U.S. (including any supra-national agency
such as in the European Union) necessary to commence human clinical trials in
such jurisdiction.

1.49 “Indication” means a separate and distinct disease, disorder, illness or
health condition for which a separate Regulatory Approval may be filed. Subtypes
of the same disease are considered different Indications if (a) a separate
pivotal trial for each such disease subtype is required for Regulatory Approval
of such disease subtype, or (b) a separate MAA or supplemental MAA is required
for Regulatory Approval for each such disease subtype.

1.50 “Initiate” means, with respect to a clinical trial, the first dosing of the
first subject in such clinical trial.

1.51 “Inventions” means all inventions, whether or not patentable, discovered,
made, conceived, or conceived and reduced to practice in the course of
activities contemplated by this Agreement.

1.52 “Joint Development Committee” or “JDC” has the meaning set forth in
Section 3.1 (Joint Development Committee).

1.53 “Joint Inventions” has the meaning set forth in Section 8.1(b) (Ownership
of Inventions).

1.54 “Joint Patents” has the meaning set forth in Section 8.1(b) (Ownership of
Inventions).

 

6.

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1.55 “Know-How” means any information, including discoveries, improvements,
modifications, processes, methods, techniques, protocols, formulas, data,
inventions, know-how, trade secrets and results, patentable or otherwise,
including physical, chemical, biological, toxicological, pharmacological,
safety, and pre-clinical and clinical data, dosage regimens, control assays, and
product specifications, but excluding any Patents.

1.56 “Latin America” means the region consisting of the following countries:
Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominican
Republic, Ecuador, El Salvador, French Guiana, Guadeloupe, Guatemala, Haiti,
Honduras, Martinique, Nicaragua, Panama, Paraguay, Peru, Uruguay and Venezuela.

1.57 “Licensed Product” means any pharmaceutical product containing a Compound
as an active ingredient, alone or in combination with one or more other
molecules or agents (excluding any proprietary molecule or agent of HanAll or
its Affiliates), in any formulation.

1.58 “Losses” has the meaning set forth in Section 10.1 (Indemnification by
HanAll).

1.59 “MAA” means a marketing authorization application or equivalent
application, and all amendments and supplements thereto, filed with the
applicable Regulatory Authority in any country in the Territory, including a BLA
in the U.S.

1.60 “Manufacturing Plan” means a written plan describing the manufacturing
activities estimated for Development of Compounds and Licensed Products in the
Territory, and for commercialization of Licensed Products following Regulatory
Approval, including a listing of CMOs selected by Roivant for supply of
Compounds and Licensed Products, specifications for Compounds and Licensed
Products, and estimated timing for manufacturing activities.

1.61 “Materials” has the meaning set forth in Section 4.4 (Materials Transfer).

1.62 “Milestone Event” means any event identified in Section 6.3 (Milestone
Payments).

1.63 “Milestone Payment” means any payment identified in Section 6.3 (Milestone
Payments) to be made by Roivant to HanAll on the occurrence of a Milestone
Event.

1.64 “Net Sales” means, with respect to any Licensed Product, the gross amounts
invoiced for sales or other dispositions of such Licensed Product by or on
behalf of Roivant and its Affiliates to Third Parties, less the following
deductions to the extent included in the gross invoiced sales price for such
Licensed Product or otherwise directly paid or incurred by Roivant or its
Affiliates, as applicable, with respect to the sale or other disposition of such
Licensed Product:

(a) [*]

Such amounts shall be determined in accordance with GAAP, consistently applied.

[*]

 

7.

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1.65 “Next Generation Compound” means any antibody developed by HanAll under the
Research Program (a) for which HanAll has conducted the activities necessary to
generate a Next Generation Data Package, (b) that is a derivative of a Compound
or a Backup Compound [*], (c) that inhibits hFcRn and (d) that would require new
nonclinical studies and human clinical trials to obtain Regulatory Approval in
the U.S. or EU.

1.66 “Next Generation Data Package” means a data package containing the
information described as deliverables in Section 3 of Exhibit E.

1.67 “Patents” means (a) all patents, certificates of invention, applications
for certificates of invention, priority patent filings and patent applications,
and (b) any renewals,

divisions, continuations (in whole or in part), or requests for continued
examination of any of such patents, certificates of invention and patent
applications, any and all patents or certificates of invention issuing thereon,
and any and all reissuances, reexaminations, extensions, divisions, renewals,
substitutions, confirmations, registrations, revalidations, revisions, and
additions of or to any of the foregoing.

1.68 “Phase 1 Clinical Trial” means a clinical trial in any country conducted in
a small number of human subjects designed or intended to establish an initial
safety profile, pharmacodynamics, or pharmacokinetics of a Compound or Licensed
Product.

1.69 “Phase 2 Clinical Trial” means a clinical trial of a Compound or Licensed
Product in human patients in any country to determine initial efficacy and dose
range finding before embarking on a Phase 3 Clinical Trial.

1.70 “Phase 3 Clinical Trial” means a pivotal clinical trial of a Compound or
Licensed Product in human patients in any country with a defined dose or a set
of defined doses of such Compound or Licensed Product designed to ascertain
efficacy and safety of such Compound or Licensed Product for the purpose of
preparing and submitting an MAA to a Regulatory Authority. Phase 3 Clinical
Trial includes a clinical trial designated as a phase 2/3 clinical trial or a
Phase 2 Clinical Trial that is intended to be a pivotal clinical trial.

1.71 “Product Infringement” has the meaning set forth in Section 8.4(a)
(Notice).

1.72 “Public Official or Entity” means (a) any officer, employee (including
physicians, hospital administrators, or other healthcare professionals), agent,
representative, department, agency, de facto official, representative, corporate
entity, instrumentality or subdivision of any government, military or
international organization, including any ministry or department of health or
any state-owned or affiliated company or hospital, or (b) any candidate for
political office, any political party or any official of a political party.

1.73 “Regulatory Approval” means any and all approvals, licenses, registrations,
permits, notifications and authorizations (or waivers) of any Regulatory
Authority that are necessary for the manufacture, use, storage, import,
transport, promotion, marketing, distribution, offer for sale, sale or other
commercialization of a Licensed Product in any country in or outside the
Territory, including pricing and reimbursement approval that is necessary for
commercial sale.

 

8.

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1.74 “Regulatory Authority” means any Governmental Authority that has
responsibility in its applicable jurisdiction over the testing, development,
manufacture, use, storage, import, transport, promotion, marketing,
distribution, offer for sale, sale or other commercialization of pharmaceutical
products in a given jurisdiction in or outside the Territory, including the FDA
and EMA. For countries where governmental approval is required for pricing or
reimbursement for a pharmaceutical product to be reimbursed by national health
insurance (or its local equivalent), Regulatory Authority shall also include any
Governmental Authority whose review or approval of pricing or reimbursement of
such product is required.

1.75 “Regulatory Exclusivity” means any exclusive marketing rights or data
exclusivity rights conferred by any Regulatory Authority with respect to a
pharmaceutical product other than Patents, including orphan drug exclusivity,
new chemical entity exclusivity, data exclusivity, or pediatric exclusivity.

1.76 “Regulatory Filings” means all applications, filings, submissions,
approvals, licenses, registrations, permits, notifications and authorizations
(or waivers) with respect to the testing, Development, manufacture or
Commercialization of any Compound or Licensed Product made to or received from
any Regulatory Authority in a given country, including any INDs and MAAs.

1.77 “Research Plan” has the meaning set forth in Section 4.1(a) (Conduct).

1.78 “Research Program” has the meaning set forth in Section 4.1(a) (Conduct).

1.79 “Research Term” has the meaning set forth in Section 4.1(a) (Conduct).

1.80 “Roivant Data” has the meaning set forth in Section 8.1(a) (Data).

1.81 “Roivant Indemnitee” has the meaning set forth in Section 10.1
(Indemnification by HanAll).

1.82 “Roivant Know-How” means all Know-How that Roivant or its Affiliate
Controls as of the Effective Date or during the Term that is necessary or
reasonably useful for the Development, manufacture or Commercialization of any
Compound or Licensed Product in the Field, including the Roivant Data, Roivant’s
Sole Inventions and Roivant’s interest in Joint Inventions.

1.83 “Roivant Patents” means all Patents that Roivant or its Affiliate Controls
as of the Effective Date or during the Term that are necessary or reasonably
useful for the Development, manufacture or Commercialization of any Compound or
Licensed Product in the Field, including Roivant’s interest in Joint Patents.

1.84 “Roivant Technology” means the Roivant Know-How and the Roivant Patents.

1.85 “Royalty Term” has the meaning set forth in Section 6.4(b) (Royalty Term).

1.86 “Rules” has the meaning set forth in Section 13.3(a) (Arbitration).

 

9.

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1.87 “Safety Data” means Data related solely to any adverse drug experiences and
serious adverse drug experiences as such information is reportable to Regulatory
Authorities in or outside the Territory. Safety Data also includes “adverse
events”, “adverse drug reactions” and “unexpected adverse drug reactions” as
defined in the ICH Harmonised Tripartite Guideline for Clinical Safety Data
Management: Definitions and Standards for Expedited Reporting.

1.88 “Sole Inventions” has the meaning set forth in Section 8.1(b) (Ownership of
Inventions).

1.89 “Sublicensee” means a Third Party to whom Roivant has granted a license or
sublicense under the HanAll Technology, in accordance with the terms of this
Agreement, to Develop, make, use or import Compounds or Licensed Products or to
promote, offer for sale or sell Licensed Products, in each case in the Field and
in the Territory.

1.90 “Tax” or “Taxes” means (a) all federal, provincial, territorial, state,
municipal, local, foreign or other taxes, imposts, rates, levies, assessments
and other charges in the nature of a tax (and all interest and penalties thereon
and additions thereto imposed by any governmental authority), including without
limitation all income, excise, franchise, gains, capital, real property, goods
and services, transfer, value added, gross receipts, windfall profits,
severance, ad valorem, personal property, production, sales, use, license,
stamp, documentary stamp, mortgage recording, employment, payroll, social
security, unemployment, disability, escheat, estimated or withholding taxes, and
all customs and import duties, together with all interest, penalties and
additions thereto imposed with respect to such amounts, in each case whether
disputed or not; (b) any liability for the payment of any amounts of the type
described in clause (a) as a result of being or having been a member of an
affiliated, consolidated, combined or unitary group; and (c) any liability for
the payment of any amounts as a result of being party to any tax sharing
agreement or arrangement or as a result of any express or implied obligation to
indemnify any other person with respect to the payment of any amounts of the
type described in clause (a) or (b).

1.91 “Term” has the meaning set forth in Section 12.1 (Term).

1.92 “Territory” means the U.S., Canada, Mexico, the European Union, the United
Kingdom, Switzerland, Middle East, North Africa, and Latin America.

1.93 “Third Party” means any entity other than HanAll or Roivant or an Affiliate
of HanAll or Roivant.

1.94 “Third Party License” means any Third Party agreement that is deemed to be
a Third Party License pursuant to Section 2.7(a) (Third Party Licenses).

1.95 “Transfer Tax” has the meaning set forth in Section 7.3(c) (Transfer Tax).

1.96 “Transfer Plan” has the meaning set forth in Section 2.4 (Initial Transfer
of Know-How and Materials).

1.97 “United States” or “U.S.” means the United States of America, including its
territories and possessions.

 

10.

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1.98 “Valid Claim” means (a) a claim of an issued and unexpired Patent that has
not been revoked or held unenforceable, unpatentable or invalid by a decision of
a court or other governmental agency of competent jurisdiction that is not
appealable or has not been appealed within the time allowed for appeal, and that
has not been abandoned, disclaimed, denied or admitted to be invalid or
unenforceable through reissue, re-examination or disclaimer or otherwise, or
(b) a claim of a Patent application pending for no more than [*] that has not
been cancelled, withdrawn or abandoned or finally rejected by an administrative
agency action from which no appeal can be taken.

2. GRANT OF LICENSES

2.1 Licenses Granted to Roivant; Sublicenses.

(a) Licenses Granted to Roivant. Subject to the terms and conditions of this
Agreement, HanAll hereby grants to Roivant, during the Term, (i) an exclusive
(even as to HanAll, except as expressly set forth herein), royalty-bearing
license, with the right to grant sublicenses in accordance with Section 2.1(b)
(Sublicenses), under the HanAll Technology to Develop, use and import Compounds
and Licensed Products in the Field and in the Territory and to promote, offer
for sale and sell Licensed Products in the Field and in the Territory and (ii) a
non-exclusive license, with the right to grant sublicenses in accordance with
Section 2.1(b) (Sublicenses), under the HanAll Technology to make Compounds and
Licensed Products in the Field and in the Territory, solely for use in
exercising the license granted in Section 2.1(a)(i) (Licenses Granted to
Roivant—Subsection (i)). Notwithstanding the foregoing license, Roivant shall
not have the right to Develop any Compound other than HL161BKN, or to Develop a
Licensed Product in any formulation other than HanAll’s formulation of HL161BKN
as in existence as of the Effective Date, in each case without the JDC’s
approval of such Compound or Licensed Product pursuant to Section 3.1(g) (Joint
Development Committee).

(b) Sublicenses. Roivant shall not have the right to grant any sublicenses to a
Third Party under the licenses granted in Section 2.1(a) (Licenses Granted to
Roivant) with respect to any Licensed Product in the U.S. or EU prior to
submission of a BLA or MAA for such Licensed Product in the U.S. or EU.
Following submission of a BLA or MAA for a Licensed Product in the U.S. or EU,
Roivant may grant a sublicense of the licenses granted in Section 2.1(a)
(Licenses Granted to Roivant) with respect to such Licensed Product in the U.S.
or EU to a Third Party without the prior written authorization of HanAll,
provided that Roivant provides HanAll with prior written notice of such
sublicense, such notice to include the name of the sublicensee and scope of the
sublicense. In addition, Roivant shall have the right to grant a sublicense of
the licenses granted in Section 2.1(a) (Licenses Granted to Roivant), without
the prior written authorization of HanAll, (A) to a Third Party in any country
in the Territory outside of the U.S. and EU and (B) to an Affiliate of Roivant,
provided that in each case (A) and (B) Roivant provides HanAll with prior
written notice of such sublicense, such notice to include the name of the
sublicensee and scope of the sublicense. Each authorized sublicense granted
hereunder, if any, whether to an Affiliate or Sublicensee, (i) shall be in
writing, (ii) shall be subject to and consistent with and shall comply with all
terms of this Agreement, (iii) shall incorporate terms and conditions sufficient
to enable Roivant to comply with this Agreement, shall grant HanAll all rights
with respect to Data and Inventions made or generated by such Affiliate or
Sublicensee as if such Data and Inventions were made or generated by Roivant,
and shall provide that HanAll is a third party

 

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beneficiary thereof. The sublicense agreement shall also prohibit any further
sublicense or assignment by an Affiliate or authorized Sublicensee without the
prior written consent of HanAll (such consent not to be unreasonably withheld).
Roivant shall be responsible for ensuring that the performance by any of its
Affiliates and Sublicensees hereunder is in accordance with the applicable terms
of this Agreement, and the grant of any such sublicense shall not relieve
Roivant of its obligations hereunder. Within [*] after execution, Roivant shall
provide HanAll with a copy of each agreement granting a sublicense under the
licenses granted in Section 2.1(a) (Licenses Granted to Roivant) to any Third
Party, which copy may be redacted of any confidential information of the
Sublicensee that is not necessary for HanAll to confirm compliance with this
Agreement.

2.2 Reserved Rights. HanAll hereby expressly reserves (a) all rights to
practice, and to grant licenses under, the HanAll Technology outside the scope
of the exclusive license granted in Section 2.1(a) (Licenses Granted to
Roivant), for any and all purposes, (b) the right to manufacture Compounds and
Licensed Products in the Territory, solely for the development and
commercialization of Compounds and Licensed Products outside the Territory,
(c) the right to conduct all activities to be conducted by HanAll as
contemplated by this Agreement and (d) the right to conduct discovery or
research activities with a Compound with or through a contract research
organization or service provider in the Territory.

2.3 No Implied Licenses; Negative Covenant. Except as set forth in this
Agreement, neither Party shall acquire any license or other intellectual
property interest, by implication or otherwise, under or to any Patents,
Know-How or other intellectual property owned or controlled by the other Party.
Each Party agrees not to, and not to permit any of its Affiliates to, practice
any Patents or Know-How licensed to it by the other Party outside the scope of
the licenses granted to it under this Agreement.

2.4 Initial Transfer of Know-How and Materials. As of the Effective Date, the
Parties have agreed on a plan for the transfer of HanAll Know-How (including the
data therein) and certain tangible materials Controlled by HanAll as of the
Effective Date to Roivant, which plan is attached hereto as Exhibit D (the
“Transfer Plan”). No later than [*] after the Effective Date and pursuant to the
Transfer Plan, HanAll shall commence disclosing and making available to Roivant
the HanAll Know-How and materials listed in the Transfer Plan, according to the
timeline set forth in the Transfer Plan. The Parties shall cooperate with each
other in good faith to enable a smooth transfer of the HanAll Know-How to
Roivant. Upon Roivant’s reasonable request, HanAll shall provide reasonable
technical assistance, including making appropriate employees available to
Roivant at reasonable times, places and frequency and upon reasonable prior
notice, for the purpose of assisting Roivant to understand and use the HanAll
Know-How in connection with Roivant’s Development of Licensed Products.

2.5 Assignment of Contracts Related to Phase I Clinical Trial. HanAll shall, and
hereby does, assign to Roivant, and Roivant shall, and hereby does, assume
HanAll’s obligations under the contracts identified on Exhibit F. Simultaneously
with the execution of this Agreement, the Parties will enter into a mutually
agreed assignment and assumption agreement assigning and delegating such
contracts from HanAll to Roivant. In the event that any such contract is not
assignable without the consent of the counterparty thereto, the Parties will use
reasonable efforts either (i) to obtain such consent from such counterparty
where possible, or (ii) to enter into some

 

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other mutually agreed arrangement designed to transfer the benefit of such
contract to Roivant and relieve HanAll of its obligations thereunder. Roivant
will be solely responsible for all costs incurred under such contracts from and
after the Effective Date or incurred prior to the Effective Date and invoiced on
or after the Effective Date.

2.6 Data and Know-How Sharing; Right of Reference; Regulatory Support Documents.

(a) Data and Know-How Sharing. Upon written request (which may be by email) of
HanAll, Roivant shall provide to HanAll, for no additional compensation, copies
of Roivant Data and Roivant Know-How reasonably useful or required by HanAll,
and upon written request (which may be by email) of Roivant, HanAll shall
provide to Roivant, for no additional compensation, copies of HanAll Data and
HanAll Know-How reasonably useful or required by Roivant, in each case with an
English translation or summary thereof, and shall reasonably cooperate with the
other Party to transfer such Data and Know-How within a reasonable time period
after its generation. Each Party shall have the right to use such Data and
Know-How provided by the other Party (and shall have the right to provide such
Data and Know-How to its licensees (in the case of HanAll) and Sublicensees (in
the case of Roivant)) solely for the Development of Compounds and Licensed
Products and the Commercialization of Licensed Products in such Party’s
territory (i.e., for Roivant, in the Territory, and for HanAll, outside the
Territory), and in the case of Roivant, in accordance with the terms of this
Agreement. Roivant shall ensure that it owns or Controls all data and Know-How
generated by Roivant or its Affiliates, Sublicensees or subcontractors that
would be Roivant Data or Roivant Know-How, respectively, if Controlled by
Roivant.

(b) Right of Reference. Each Party grants to the other Party (which other Party
may grant such right to its Affiliates and licensees (in the case of HanAll) or
Sublicensees (in the case of Roivant)) the right to cross-reference the
Regulatory Filings Controlled by such Party, solely for the purpose of obtaining
and maintaining Regulatory Approval for Licensed Products in the Field in such
Party’s territory (i.e., for Roivant, in the Territory, and for HanAll, outside
the Territory), in the case of Roivant, in accordance with the terms of this
Agreement.

(c) Regulatory Support. Promptly after obtaining approval of an MAA for a
Licensed Product containing HL161BKN in any country and upon written request of
a Party, the other Party shall provide to the requesting Party all supporting
documents, to the extent generated by or on behalf of or available to such Party
or its Affiliate or licensee or Sublicensee, reasonably necessary for the other
Party or its Affiliate or licensee or Sublicensee to obtain Regulatory Approval
of such Licensed Product in its respective territory, including notarized
certificate of pharmaceutical product (“CPP”), notarized power of attorney
permitting use of the CPP, and ICH Common Technical Dossier Modules 1, 2, 3, 4
and 5, demonstrating that such Licensed Product has obtained Regulatory Approval
in the applicable country or regulatory jurisdiction (collectively, the
“Supporting Documents”). Each Party shall have the right to provide the
Supporting Documents to its licensees or Sublicensees, solely for the purpose of
obtaining Regulatory Approval of such Licensed Product in the applicable
territory. Each Party shall ensure that each applicable agreement it enters with
a Third Party contractor or licensee or Sublicensee requires the Third Party to
provide such Party with the Supporting Documents owned or controlled by such
Third Party and grants such Party the right to provide such Supporting Documents
to the other Party for use as contemplated in this Agreement.    

 

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2.7 Third Party Licenses.

(a) If HanAll enters into any agreement with a Third Party after the Effective
Date that includes a license from such Third Party to HanAll under any Know-How
or Patents that are necessary or reasonably useful to Develop, manufacture or
Commercialize any Compound or Licensed Product in the Field and in the
Territory, then HanAll shall promptly notify Roivant, identifying the relevant
Know-How or Patents. Such license agreement shall be deemed a Third Party
License, and such Know-How and Patents, to the extent falling within the
definition of HanAll Technology, will be sublicensed to Roivant, at Roivant’s
sole discretion, only if: (i) HanAll discloses the substantive terms of the
applicable license agreement to Roivant, to the extent applicable to the rights
that would be sublicensed to Roivant, which HanAll hereby agrees to do, and
(ii) Roivant provides HanAll with written notice in which: (1) Roivant consents
to adding such Patents and Know-How to the definition of HanAll Technology and
such license agreement to the definition of Third Party License; (2) Roivant
agrees to be responsible for all payments that would be owed under such license
agreement as a result of HanAll’s granting a sublicense to Roivant or Roivant’s
granting a sublicense or practice thereunder, including Roivant’s and its
Affiliates’ and Sublicensees’ Development, manufacture, use and importation of
Compounds and Licensed Products, and promotion, offer for sale and sale of
Licensed Products, and a reasonable allocation of all other payments under such
agreement, and to make all payments when due and provide all reports required
under such license agreement; and (3) Roivant acknowledges in writing that its
sublicense under such license agreement is subject to the terms and conditions
of such license agreement.

(b) If Roivant elects to obtain a sublicense in accordance with Section 2.7(a)
(Third Party Licenses), Roivant shall (i) provide HanAll, in a timely manner as
necessary for HanAll to comply with its obligations under each Third Party
License, with all information needed in order to determine the requirement to
make, and the amount of, any payment thereunder, to the extent resulting from
the grant, maintenance or exercise of a sublicense to Roivant and (ii) promptly
(but in no event later than [*] days after HanAll’s submission of an invoice
therefor) reimburse HanAll for the full amount of each such payment.

2.8 Competing Products.

(a) HanAll.

(i) During the Term, except for activities permitted under this Agreement,
HanAll shall not, and shall ensure that its Affiliates do not, directly or
indirectly, itself or with or through any Third Party, clinically develop or
commercialize any Competing Product in the Field in the Territory.

(ii) In the event that HanAll or its Affiliate, either through its own efforts
or by acquisition of such rights (whether through merger, acquisition or similar
transaction), obtains the rights to a Competing Product that would cause HanAll
to breach Section 2.8(a)(i) (HanAll - Subsection(i)), then HanAll shall not be
deemed in breach of Section 2.8(a)(i) (HanAll

 

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- Subsection(i)) if (A) (1) HanAll or its Affiliate or other applicable entity
Divests such Competing Product in the Territory within [*], subject to
compliance with Applicable Laws, from the date HanAll or the applicable
Affiliate obtained any rights in such Competing Product in the Territory and
(2) all activities by HanAll or the applicable Affiliate with respect to such
Competing Product during such [*] period are conducted independently of the
activities conducted under this Agreement with customary firewall separations
and no HanAll Technology, HanAll Data, Roivant Technology or Roivant Data is
used in the conduct of such activities; or (B) (1) HanAll or its applicable
Affiliate terminates the research, development, manufacture and
commercialization of the Competing Product in the Field in the Territory within
[*], subject to compliance with Applicable Laws, from the date HanAll or the
applicable Affiliate obtained any rights in such Competing Product in the
Territory and (2) all activities by HanAll or its applicable Affiliate with
respect to such Competing Product during such [*] period are conducted
independently of the activities conducted under this Agreement with customary
firewall separations and no HanAll Technology, HanAll Data, Roivant Technology
or Roivant Data is used in the conduct of such activities.

(b) Roivant.

(i) During the Term, except for activities permitted under this Agreement,
Roivant shall not, and shall ensure that its Affiliates do not, directly or
indirectly, itself or with or through any Third Party, research, develop,
manufacture or commercialize any Competing Product in the Field in the
Territory.

(ii) In the event that Roivant or its Affiliate, either through its own efforts
or by acquisition of such rights (whether through merger, acquisition or similar
transaction), obtains the rights to a Competing Product that would cause Roivant
to breach Section 2.8(b)(i) (Roivant - Subsection(i)), then Roivant shall not be
deemed in breach of Section 2.8(b)(i) (Roivant—Subsection(i)) if (A) (1) Roivant
or its Affiliate or other applicable entity Divests such Competing Product in
the Territory within [*], subject to compliance with Applicable Laws, from the
date Roivant or the applicable Affiliate obtained any rights in such Competing
Product in the Territory and (2) all activities by Roivant or the applicable
Affiliate with respect to such Competing Product during such [*] period are
conducted independently of the activities conducted under this Agreement with
customary firewall separations and no HanAll Technology, HanAll Data, Roivant
Technology or Roivant Data is used in the conduct of such activities; or (B) (1)
Roivant or its applicable Affiliate terminates the research, development,
manufacture, and commercialization of the Competing Product in the Field in the
Territory within twelve (12) months, subject to compliance with Applicable Laws,
from the date Roivant or the applicable Affiliate obtained any rights in such
Competing Product in the Territory and (2) all activities by Roivant or its
applicable Affiliate with respect to such Competing Product during such [*]
period are conducted independently of the activities conducted under this
Agreement with customary firewall separations and no HanAll Technology, HanAll
Data, Roivant Technology or Roivant Data is used in the conduct of such
activities.

[*]

3. GOVERNANCE

 

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3.1 Joint Development Committee. Within [*] after the Effective Date, the
Parties shall establish a joint development committee (the “Joint Development
Committee” or the “JDC”), composed of three (3) representatives of each Party,
to guide the collaboration of the Parties under this Agreement and to oversee
the exchange of information between the Parties with respect to the Development,
manufacture, and Commercialization of Compounds and Licensed Products in and
outside of the Territory. Each JDC representative shall have appropriate
knowledge and expertise and sufficient seniority within the applicable Party to
make decisions arising within the scope of the JDC’s responsibilities. The JDC
shall in particular:

(a) [*].

The JDC shall have only such powers as are expressly assigned to it in this
Agreement, and such powers shall be subject to the terms and conditions of this
Agreement. For clarity, the JDC shall primarily be advisory and provide a forum
for information exchange, and it shall not have any decision-making authority
except for its approval rights as expressly set forth under clauses (f), (g) and
(j) of this Section 3.1 (Joint Development Committee). HanAll understands and
agrees that subject to the terms of this Agreement, including Sections 3.3 (JDC
Decision-Making) and 4.9 (Diligence Obligations), Roivant will have the sole and
final decision making authority with respect to the Development (including any
changes or amendments to the Development Plan), manufacture and
Commercialization of Compounds and Licensed Products in the Territory. Without
limiting the foregoing, the JDC will not have the power to amend this Agreement,
and no decision of the JDC may be in contravention of any terms and conditions
of this Agreement.

3.2 JDC Membership and Meetings.

(a) Members. Each Party shall notify the other Party of its JDC members within
[*] after the Effective Date. Each Party may replace its JDC representatives on
written notice to the other Party, but each Party shall strive to maintain
continuity in the representation of its JDC members. Each Party shall appoint
one (1) of its JDC representatives to act as a co-chairperson of the JDC. The
co-chairpersons shall jointly prepare and circulate agendas to JDC members at
least seven (7) days before each JDC meeting and shall direct the preparation of
reasonably detailed minutes for each JDC meeting, which shall be approved by the
co-chairpersons and circulated to JDC members within [*] of such meeting.

(b) Meetings. The JDC shall hold meetings at such times as it elects to do so,
but in no event shall such meetings be held less frequently than (i) [*] during
Calendar Year 2018, (ii) [*] thereafter and prior to the first Regulatory
Approval in the Territory of a Licensed Product in the first Indication and
(iii) thereafter, [*]. Meetings may be held in person, or by audio or video
teleconference; provided, that unless otherwise agreed by both Parties, at least
one (1) meeting per year shall be held in person, and all in-person JDC meetings
shall be held at locations alternately selected by the Parties. Each Party shall
be responsible for all of its own expenses of participating in JDC meetings. No
action taken at any meeting of the JDC shall be effective unless at least one
(1) representative of each Party is participating.

 

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(c) Non-Member Attendance. Each Party may from time to time invite a reasonable
number of participants, in addition to its representatives, to attend JDC
meetings in a non-voting capacity; provided, that if either Party intends to
have any Third Party (including any consultant) attend such a meeting, such
Party shall provide at least [*] prior written notice to the other Party and
obtain the other Party’s approval for such Third Party to attend such meeting,
which approval shall not be unreasonably withheld or delayed. Such Party shall
ensure that such Third Party is bound by confidentiality and non-use obligations
consistent with the terms of this Agreement.

3.3 JDC Decision-Making. All decisions of the JDC shall be made by unanimous
vote, with each Party’s representatives collectively having one (1) vote. If
after reasonable discussion and good faith consideration of each Party’s view on
a particular matter before the JDC, the representatives of the Parties cannot
reach an agreement as to such matter within [*] after such matter was brought to
the JDC for resolution, such disagreement shall be referred to the Chief
Executive Officer of HanAll (or his or her designee) and the Chief Executive
Officer of Roivant (or his or her designee) (collectively, the “Executive
Officers”) for resolution, who shall use good faith efforts to resolve such
matter within [*] after it is referred to them. If the Executive Officers are
unable to reach consensus on any such matter during such period, then (a) for
any decision under Section 3.1(f) (Joint Development Committee—Subsection (f)),
the Chief Executive Officer of Roivant shall have the right to decide, provided
that Roivant provides HanAll’s JDC representatives with detailed documentation
of the cause of the delay and its analysis of the required timeline resulting
from such delay, (b) for any decision under Section 3.1(g) (Joint Development
Committee—Subsection (g)), the status quo (as reflected in the then-current
Development Plan, where applicable) shall be maintained and (c) for any decision
under Section 3.1(j) (Joint Development Committee—Subsection (g)), the initial
detailed Research Plan may be approved only by unanimous approval of the JDC
members or the Parties, and for any amendment to the Research Plan, the decision
of the Chief Executive Officer of HanAll (or his or her designee) shall be
final, except that HanAll may not amend the Research Plan in a manner that
increases the total budget thereunder by more than [*] without Roivant’s prior
written consent, which shall not be unreasonably withheld.

3.4 Alliance Managers. Promptly after the Effective Date, each Party shall
appoint an individual to act as the alliance manager for such Party (the
“Alliance Manager”), which individual may also be a JDC member. Each Alliance
Manager shall be responsible for alliance management between the Parties on a
day-to-day basis throughout the Term. If not a member of the JDC, each Alliance
Manager shall be permitted to attend meetings of the JDC as non-voting
participants. The Alliance Managers shall be the primary contact for the Parties
regarding the activities contemplated by this Agreement and shall facilitate all
such activities hereunder. Each Party may replace its Alliance Manager with an
alternative representative at any time upon written notice to the other Party.
Any Alliance Manager may designate a substitute to temporarily perform the
functions of that Alliance Manager upon written notice to the other Party. Each
Alliance Manager shall be charged with creating and maintaining a collaborative
work environment within the JDC and between the Parties.

 

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4. RESEARCH, DEVELOPMENT AND COMMERCIALIZATION

4.1 Research Program.

(a) Conduct. During the Research Term, HanAll shall conduct a research program
(i) intended to generate antibodies that are derivatives of HL161BKN or any
Backup Compound, that inhibit hFcRn and that have significantly improved
pharmacokinetic and/or pharmacodynamics profiles, as compared with HL161BKN and
Backup Compounds and (ii) including certain process optimization, scale-up and
non-clinical studies for HL161BKN (the “Research Program”). The initial
high-level plan for the Research Program is attached hereto as Exhibit G. Within
[*] after the Effective Date, HanAll shall prepare a detailed research plan,
including budget and timelines, consistent with the initial high-level plan (as
approved and amended in accordance with this Agreement, the “Research Plan”) for
the JDC’s review and approval, which must be by unanimous approval of the JDC
members or the Parties. From time to time during the Research Term, HanAll shall
prepare an amendment, as appropriate, to the then-current Research Plan and
shall submit such amendment to the JDC for review and approval. If the terms of
the Research Plan contradict, or create inconsistencies or ambiguities with, the
terms of this Agreement, then the terms of this Agreement shall govern. The
Research Program shall commence on the Effective Date and continue until the
earlier of (i) HanAll’s completion of activities necessary to generate a Next
Generation Data Package and HanAll’s delivery of the Next Generation Data
Package to Roivant and (ii) the [*] of the Effective Date (such period, the
“Research Term”). HanAll shall prepare and provide the Next Generation Data
Package to Roivant promptly after completion of all applicable activities, to
the extent that such activities are completed prior to the [*] of the Effective
Date. HanAll shall conduct all activities under the Research Program in
compliance with all Applicable Laws.

(b) Records and Updates. HanAll shall maintain records, in sufficient detail and
in good scientific manner appropriate for patent and regulatory purposes, which
shall fully and properly reflect all work done and results achieved by or on
behalf of HanAll in the performance of the Research Program. HanAll shall keep
the JDC regularly informed of the status of all activities under the Research
Program. Without limiting the foregoing, at least every [*] during the Research
Term, HanAll shall provide the JDC (or the Alliance Managers, if the JDC will
not be meeting during a [*] with summaries in reasonable detail of all data and
results generated or obtained in the course of HanAll’s performance of the
Research Program.

(c) Costs. The Parties shall share equally all costs and expenses HanAll incurs
to conduct the Research Program, and Roivant shall pay its share of such costs
and expenses pursuant to Section 6.2 (Research Program Funding).

4.2 Development

(a) Development Responsibilities. Subject to the terms and conditions of this
Agreement, Roivant shall be responsible, at its sole cost and expense, for all
Development of Compounds and Licensed Products in the Field in the Territory,
including all preclinical studies, clinical trials and regulatory activities,
that are necessary for or otherwise support obtaining and maintaining Regulatory
Approvals in the Field in the Territory.

(b) Development Plan. Roivant shall conduct all Development of Compounds and
Licensed Products in the Field in the Territory in accordance with a
comprehensive development plan (as amended in accordance with this Agreement,
the “Development Plan”), the initial version of which Roivant will prepare and
provide to the JDC within [*] after the Effective Date. The initial version of
the Development Plan must be consistent with the

 

18.

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timelines set forth in Exhibit B. The Parties agree that Roivant will include
the following information in the Development Plan: [*]. From time to time, but
at least every [*], Roivant will update the Development Plan and submit such
updated plan to the JDC for review, discussion and, to the extent provided in
Section 3.1 (Joint Development Committee), approval. In addition, upon deciding
to commence Development of any Compound other than HL161BKN, and in any event
prior to commencing IND-enabling studies with such Compound, Roivant will update
the Development Plan to include the information described in this Section 4.2(b)
(Development Plan) for such Compound and will submit such plan to the JDC for
review and discussion. If the terms of the Development Plan contradict, or
create inconsistencies or ambiguities with, the terms of this Agreement, then
the terms of this Agreement shall govern.

(c) Conduct of Development Activities. Roivant shall Develop Compounds and
Licensed Products in the Field in the Territory in compliance with all
Applicable Laws, including good scientific and clinical practices under the
Applicable Laws of the country in which such activities are conducted.

(d) Records and Updates. Roivant shall maintain records, in sufficient detail
and in good scientific manner appropriate for patent and regulatory purposes,
which shall fully and properly reflect all work done and results achieved by or
on behalf of Roivant in the performance of Development activities pursuant to
this Agreement. Roivant shall keep the JDC regularly informed of the status of
all material Development activities conducted with respect to Compounds and
Licensed Products in the Field in the Territory pursuant to this Agreement.
Without limiting the foregoing, at least [*] during Calendar Year 2018 and at
least every [*] thereafter, Roivant shall provide the JDC or HanAll with
summaries in reasonable detail of all data and results generated or obtained in
the course of Roivant’s and its Affiliates’ or Sublicensees’ performance of
activities with respect to Compounds and Licensed Products in the Field in the
Territory, covering subject matter at a level of detail reasonably requested by
HanAll and sufficient to enable HanAll to determine Roivant’s compliance with
its diligence obligations under Section 4.9 (Diligence Obligations). HanAll will
have the right to provide all information and data disclosed by Roivant under
this Section 4.2(d) (Records and Updates)to its licensees of Licensed Products
outside the Territory.

4.3 Use of Subcontractors. Roivant may perform its Development, regulatory and
manufacturing activities under this Agreement, and HanAll may perform its
activities under the Research Program, in each case through one (1) or more
subcontractors, provided that (a) such Party will remain responsible for the
work allocated to, and payment to, such subcontractors to the same extent it
would if it had done such work itself; (b) each subcontractor undertakes in
writing obligations of confidentiality and non-use regarding Confidential
Information that are substantially the same as those undertaken by the Parties
pursuant to Article 11 (Confidentiality), and (c) each subcontractor agrees in
writing to assign all Inventions and intellectual property developed in the
course of performing any such work, including all Data, to such Party. A Party
may also subcontract work on terms other than those set forth in this
Section 4.3 (Use of Subcontractors) with the prior written approval of the other
Party.

 

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4.4 Materials Transfer. In order to facilitate the Development and manufacturing
activities contemplated by this Agreement, HanAll may provide to Roivant certain
biological materials or chemical compounds Controlled by HanAll, as and to the
extent provided in the Transfer Plan (collectively, “Materials”) for use by
Roivant in furtherance of such Development and manufacturing activities. Except
as otherwise provided for under this Agreement, all such Materials delivered
will be used only in furtherance of the Development and manufacturing activities
conducted in accordance with this Agreement, will not be used by or delivered to
or for the benefit of any Third Party, except for subcontractors, without the
prior written consent of HanAll, and will be used in compliance with all
Applicable Laws. Roivant agrees to use all Materials supplied under this
Agreement with prudence and appropriate caution and acknowledges that not all of
the characteristics of the Materials are currently known. Except as expressly
set forth in this Agreement, THE MATERIALS ARE PROVIDED “AS IS” AND WITHOUT ANY
REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY
IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR
ANY WARRANTY THAT THE USE OF THE MATERIALS WILL NOT INFRINGE OR VIOLATE ANY
PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY.

4.5 Conduct of Regulatory Activities. Subject to the terms and conditions of
this Agreement, Roivant shall be solely responsible for formulating regulatory
strategy and for preparing, filing, obtaining and maintaining INDs and
Regulatory Approvals for Licensed Products in the Territory, and as between the
Parties, HanAll shall be solely responsible for formulating regulatory strategy
and for preparing, filing, obtaining and maintaining INDs and Regulatory
Approvals for Licensed Products outside the Territory. Roivant shall be the
holder of all Regulatory Approvals for Licensed Products in the Territory and
shall have responsibility for interactions with Regulatory Authorities with
respect to Licensed Products in the Territory, and as between the Parties,
HanAll shall be the holder of all Regulatory Approvals for Licensed Products
outside the Territory and shall have responsibility for interactions with
Regulatory Authorities with respect to Licensed Products outside the Territory.
The Parties shall consult through the JDC regarding, and each Party shall keep
the other Party regularly and fully informed of, the preparation, Regulatory
Authority review and approval of submissions and communications with Regulatory
Authorities with respect to Compounds and Licensed Products, subject, in the
case of HanAll, to its confidentiality obligations to Third Parties; provided
that HanAll shall use reasonable efforts to obtain the right from its licensees
to provide such information to Roivant, and in any event HanAll will provide
Safety Data (whether generated by HanAll or its licensee) to Roivant pursuant to
Section 4.6 (Adverse Event Reporting; Pharmacovigilance Agreement). In addition,
each Party shall promptly provide the other Party with copies of all material
documents, information and correspondence received from a Regulatory Authority,
with an English translation thereof (if applicable) and, upon reasonable
request, with copies of any other documents, reports and communications from or
to any Regulatory Authority relating to Compounds, Licensed Products or
activities under this Agreement, with an English translation thereof (if
applicable), subject, in the case of HanAll, to its confidentiality obligations
to Third Parties. HanAll’s confidentiality obligations to Third Party licensees
will not prevent the disclosure to Roivant of information that is material to
the Compounds and Licensed Products. Each Party shall bear all expenses it
incurs to conduct all regulatory activities with respect to Compounds and
Licensed Products.

4.6 Adverse Event Reporting; Pharmacovigilance Agreement. As between the
Parties: (a) HanAll shall be responsible for the timely reporting of all
relevant adverse drug reactions/experiences, Licensed Product quality, Licensed
Product complaints and Safety Data

 

20.

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relating to Compounds and Licensed Products to the appropriate Regulatory
Authorities outside the Territory; and (b) Roivant shall be responsible for the
timely reporting of all relevant adverse drug reactions/experiences, Licensed
Product quality, Licensed Product complaints and Safety Data relating to
Compounds and Licensed Products to the appropriate Regulatory Authorities in the
Territory, in each case in accordance with Applicable Laws of the relevant
countries and Regulatory Authorities. On or before the Initiation of the first
Phase 1 Clinical Trial in the Territory, if practicable, and as soon as possible
if not practicable, Roivant shall assume responsibility for and thereafter
maintain the global safety database for Compounds and Licensed Products, and
HanAll shall be entitled to maintain a mirror database. The Parties shall
cooperate with each other with respect to their respective pharmacovigilance
responsibilities, and each Party shall be solely responsible for costs relating
to its respective pharmacovigilance responsibilities. Within [*] after the
Effective Date, the Parties shall enter into a pharmacovigilance agreement on
terms that comply with ICH guidelines, including: (i) providing detailed
procedures regarding the maintenance of core safety information and the exchange
of Safety Data relating to Compounds and Licensed Products worldwide within
appropriate timeframes and in an appropriate format to enable each Party to meet
both expedited and periodic regulatory reporting requirements; and (ii) ensuring
compliance with the reporting requirements of all applicable Regulatory
Authorities on a worldwide basis for the reporting of Safety Data in accordance
with standards stipulated in the ICH guidelines, and all applicable regulatory
and legal requirements regarding the management of Safety Data.

4.7 Commercialization. Subject to the terms and conditions of this Agreement,
Roivant shall have the exclusive right to Commercialize Licensed Products in the
Field in the Territory during the Term. Without limiting the foregoing, during
the Term, Roivant will have the exclusive right and responsibility for the
following with respect to Licensed Products in the Field in the Territory:
(a) establishing the Commercialization (including marketing) strategy and
tactics; (b) establishing pricing and reimbursement; (c) managed care
contracting; (d) receiving, accepting and filling orders; (e) distribution to
customers; (f) controlling invoicing, order processing and collecting accounts
receivable for sales; and (g) recording sales in its books of account for sales.

4.8 Commercialization Plan and Report. Within a reasonable time (but no later
than six (6) months) prior to the first anticipated Regulatory Approval of a
Licensed Product in each country in the Territory, Roivant shall prepare and
provide to the JDC for discussion a non- binding plan for the Commercialization
(including marketing, promotion and pricing) of Licensed Products in the Field
in such country during the [*] after First Commercial Sale in such country,
which plan shall be reasonable in scope and detail and may be amended by Roivant
(the “Commercialization Plan” for such country). Roivant shall update each
Commercialization Plan on an annual basis (to cover the subsequent [*] and shall
promptly provide each such update and any material amendments to each
Commercialization Plan to the JDC and HanAll. On an annual basis commencing on
the First Commercial Sale of any Licensed Product anywhere in the Territory,
Roivant shall provide HanAll with a report detailing its Commercialization
activities with respect to Licensed Products in the previous [*] period,
covering subject matter at a level of detail reasonably requested by HanAll and
sufficient to enable HanAll to determine Roivant’s compliance with its diligence
obligations under Section 4.9 (Diligence Obligations).

 

21.

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4.9 Diligence Obligations.

(a) General. During the Term, Roivant shall, and shall cause its Affiliates and
Sublicensees to, use Commercially Reasonable Efforts to Develop and seek and
obtain Regulatory Approval of Licensed Products in the Field in the Territory
and, upon obtaining Regulatory Approval for a Licensed Product in any Indication
and country, to Commercialize such Licensed Product in such country.

(b) Specific Timelines. Without limiting Section 4.9(a) (General), Roivant
shall, and shall cause its Affiliates and Sublicensees to, use Commercially
Reasonable Efforts to achieve each of the following milestone events for
Licensed Products containing HL161BKN by the corresponding date set forth in the
Development Plan: [*]. Roivant shall notify the JDC and HanAll promptly if it
becomes aware (and in any event within [*] after becoming aware) that it is
unlikely to achieve any such milestone event by the projected date, and the JDC
will discuss in good faith any updates to the projected dates in the Development
Plan.

4.10 Ex-Territory and Ex-Field Activities.

(a) Roivant hereby covenants and agrees that during the Term it shall not (and
shall cause its Affiliates, Sublicensees, and subcontractors not to), either
itself or through a Third Party, market, promote, sell or actively offer for
sale Licensed Products outside the Field in the Territory or outside of the
Territory in or outside of the Field. Without limiting the generality of the
foregoing, with respect to countries outside of the Territory, Roivant shall not
(i) engage in any advertising activities relating to Licensed Products directed
primarily to customers outside the Territory (which excludes any participation
in conferences, congresses or scientific or medical meetings held throughout the
world), or (ii) actively or intentionally solicit orders from any prospective
purchaser located outside the Territory. To the extent permitted by Applicable
Laws, if Roivant receives any order from a prospective purchaser located in a
country outside of the Territory, Roivant shall immediately refer that order to
HanAll and shall not accept any such order or deliver or tender (or cause to be
delivered or tendered) the Licensed Product under such order. If Roivant should
reasonably know that its customer or distributor is actively engaged itself or
through a Third Party in the sale or distribution of any Licensed Product
outside of the Territory or outside the Field within the Territory, then Roivant
shall (A) within [*] of gaining knowledge of such activities, notify HanAll
regarding such activities and provide all information available to Roivant that
HanAll may reasonably request concerning such activities and (B) use
Commercially Reasonable Efforts (including cessation of sales to such customer)
necessary to limit such sale or distribution outside the Territory or the Field,
unless otherwise agreed in writing by the Parties.

(b) HanAll hereby covenants and agrees that during the Term it shall not (and
shall cause its Affiliates and subcontractors not to), either itself or through
a Third Party, market, promote, sell or actively offer for sale Licensed
Products for use in the Field in the Territory. Without limiting the generality
of the foregoing, with respect to countries within the Territory, HanAll shall
not (i) engage in any advertising activities relating to Licensed Products for
use in the Field directed primarily to customers located in such countries
within the Territory (which excludes any participation in conferences,
congresses or scientific or medical meetings held throughout the world), or
(ii) actively or intentionally solicit orders from any prospective purchaser of
a Licensed Product for use in the Field located in such countries within the
Territory. To the extent permitted by Applicable Laws, if HanAll receives any
order from a prospective purchaser for a Licensed Product in the Field located
in a country inside of the Territory, HanAll shall

 

22.

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immediately refer that order to Roivant and shall not accept any such order or
deliver or tender (or cause to be delivered or tendered) the Licensed Product
under such order. If HanAll should reasonably know that its customer or
distributor is actively engaged itself or through a Third Party in the sale or
distribution of any Licensed Product inside the Territory in the Field, then
HanAll shall (A) within ten [*] of gaining knowledge of such activities, notify
Roivant regarding such activities and provide all information available to
HanAll that Roivant may reasonably request concerning such activities and
(B) use Commercially Reasonable Efforts (including cessation of sales to such
customer) necessary to limit such sale or distribution inside the Territory in
the Field, unless otherwise agreed in writing by the Parties.

5. MANUFACTURE AND SUPPLY.

5.1 Responsibilities. Except for Compounds used by HanAll under the Research
Program and any Materials provided by HanAll, Roivant shall be solely
responsible for all preclinical, clinical and commercial manufacture and supply
of Compounds and Licensed Products for all uses under this Agreement, at its
sole expense, and shall conduct such activities in accordance with the
Manufacturing Plan. Roivant may conduct such manufacturing activities itself or
through a Third Party CMO, including a CMO used by HanAll to manufacture
Compounds or Licensed Products. Roivant shall not restrict any CMO used by
Roivant or its Affiliates for the supply of Compounds or Licensed Products from
supplying such Compounds or Licensed Products to HanAll and its Affiliates and
licensees, and Roivant shall provide any authorizations reasonably necessary and
reasonably requested by HanAll for such CMOs and shall allow use of Roivant
Know-How in connection with such manufacture and supply to HanAll and its
Affiliates and licensees.

5.2 Manufacturing Plan. Promptly after the relevant information is available,
Roivant shall prepare the Manufacturing Plan for review by the JDC. Roivant
shall update the Manufacturing Plan from time to time as necessary, and in any
case on an annual basis, and shall submit each updated Manufacturing Plan to the
JDC for review. Following the First Commercial Sale of a Licensed Product in any
country, Roivant’s obligation to submit updated Manufacturing Plans to the JDC
will cease.

6. FEES AND PAYMENTS

6.1 Upfront Payment. Roivant shall make a one-time, non-refundable,
non-creditable upfront payment of thirty million U.S. dollars ($30,000,000) to
HanAll within ten (10) Business Days after the Effective Date.

6.2 Research Program Funding. As a collaboration partner in the Research
Program, Roivant shall be responsible for fifty percent (50%) of the costs
(including internal costs (at the FTE Rate) and out-of-pocket costs) incurred by
HanAll to conduct the Research Program, subject to a maximum amount for which
Roivant is responsible of twenty million U.S. dollars ($20,000,000). Such costs
shall be paid as follows:

 

23.

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(a) For the first [*] after the date of the JDC’s approval of the initial
Research Plan (the “Approval Date”), Roivant shall pay such amounts in advance
on a [*] as follows. Promptly after the Approval Date, HanAll shall invoice
Roivant for [*] of the amount set forth in the budget in the Research Plan to be
incurred in the [*] after the Approval Date. On or promptly after the dates that
are [*] after the Approval Date, HanAll will (i) determine the difference
between the amounts advanced by Roivant for the preceding [*] of the actual
amounts incurred by HanAll to conduct the Research Program during such preceding
[*]; and (ii) invoice Roivant for [*] of the amount set forth in the budget in
the Research Plan to be incurred in the [*] period after the Approval Date, as
adjusted by the amount determined in (i), and shall include with such invoice a
calculation of the amount determined in (i).

(b) Commencing on the first anniversary of the Approval Date, Roivant shall pay
such amounts in advance on an annual basis as follows. On or promptly after the
first anniversary of the Approval Date, HanAll shall (i) determine the
difference between the amounts advanced by Roivant for the preceding [*] of the
actual amounts incurred by HanAll to conduct the Research Program during such
preceding [*]; and (ii) invoice Roivant for [*] of the amounts set forth in the
budget in the Research Plan to be incurred in the [*] period after the first
anniversary of the Approval Date, as adjusted by the amount determined in (i),
and shall include with such invoice a calculation of the amount determined in
(i). Promptly after each anniversary of the Approval Date beginning with the
second anniversary, HanAll will determine the difference between the amount
advanced by Roivant for the preceding [*] period and the actual amount incurred
by HanAll to conduct the Research Program during such preceding [*] period (the
“Research Adjustment”). Commencing on or promptly after the second anniversary
of the Approval Data, and on or promptly after each anniversary thereof during
the Research Term, HanAll shall invoice Roivant for [*] of the amounts set forth
in the budget in the Research Plan to be incurred in the [*] period after such
anniversary, as adjusted by the Research Adjustment, and shall include with such
invoice a calculation of the Research Adjustment. After the end of the Research
Term, HanAll will conduct a final reconciliation and issue an invoice or credit
to Roivant for the difference between the amounts paid by Roivant under this
Section 6.2 (Research Program Funding) and [*] of the amounts actually incurred
by HanAll to conduct the Research Program.

(c) Roivant shall remit payment to HanAll within [*] of receipt of each invoice
under this Section 6.2 (Research Program Funding).

6.3 Milestone Payments.

(a) Development and Regulatory Milestone Payments.

(i) Within [*] after the first achievement of each Milestone Event below by or
on behalf of Roivant or any of its Affiliates or Sublicensees, including any
Milestone Events due pursuant to subsections (iii)-(vi) of this Section 6.3(a)
(Development and Regulatory Milestone Payments), Roivant shall notify HanAll of
the achievement of such Milestone Event. HanAll shall invoice Roivant for the
applicable non- refundable, non-creditable Milestone Payment corresponding to
such Milestone Event as shown below. Roivant shall remit payment to HanAll
within [*] of the receipt of such invoice.

 

24.

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Development and Regulatory Milestone Events

   Milestone Payments (in
U.S. Dollars)

[*]

   [*]

[*]

   [*]

[*]

   [*]

[*]

   [*]

[*]

   [*]

[*]

   [*]

[*]

   [*]

[*]

   [*]

[*]

   [*]

[*]

   [*]

[*]

   [*]

(ii) For clarity, the Milestone Payments set forth in Section 6.3(a)(i)
(Development and Regulatory Milestone Payments) shall be payable only once, upon
the first achievement of the applicable Milestone Event by a Licensed Product,
even if the same Milestone Event is later achieved by another Licensed Product.
Milestone Events may be achieved by the same or different Licensed Product, and
FDA and EMA Milestone Events may be achieved for the same or different
Indications.

(iii) If an EMA or FDA approval Milestone Event is achieved for a Licensed
Product and Indication and payment with respect to any [*] Milestone Event for
such Indication has not been made (whether or not such previous Milestone Event
was achieved), then such previous Milestone Event shall be deemed achieved, and
Roivant shall promptly pay HanAll such unpaid previous Milestone Payment(s).

(iv) If Roivant conducts a clinical trial categorized as a [*], the [*] will be
due upon the Initiation of such clinical trial and the [*] will be due upon [*].

(v) If Roivant Initiates a [*] for a Licensed Product without [*] of such
Licensed Product, then the Milestone Payment for [*] (if not previously paid)
shall also become due and payable upon the [*]; provided, that if at the time
that such [*].

(vi) [*].

 

25.

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(b) Sales Milestone Payments.

(i) Subject to Section 6.3(b)(ii) (Sales Milestone Payments), within fifteen
(15) days after the end of each [*] in which aggregate annual Net Sales of all
Licensed Products in the Field in the Territory first reach any threshold
indicated in the Milestone Events listed below, Roivant shall notify HanAll of
the achievement of such Milestone Event. HanAll shall invoice Roivant for the
corresponding non-refundable, non-creditable Milestone Payment set forth below.
Roivant shall remit payment to HanAll within [*] of the receipt of such invoice.

 

Annual Net Sales Milestone Events

   Milestone Payments (in
U.S. Dollars)

First Calendar Year in which aggregate annual Net Sales of Licensed Products in
the Territory equal or exceed [*]

   [*]

First Calendar Year in which aggregate annual Net Sales of Licensed Products in
the Territory equal or exceed [*]

   [*]

First Calendar Year in which aggregate annual Net Sales of Licensed Products in
the Territory equal or exceed [*]

   [*]

First Calendar Year in which aggregate annual Net Sales of Licensed Products in
the Territory equal or exceed [*]

   [*]

First Calendar Year in which aggregate annual Net Sales of Licensed Products in
the Territory equal or exceed [*]

   [*]

First Calendar Year in which aggregate annual Net Sales of Licensed Products in
the Territory equal or exceed [*]

   [*]

Total Sales Milestone Payments

   [*]

(ii) For purposes of determining whether a Net Sales Milestone Event has been
achieved, Net Sales of all Licensed Products in the Territory shall be
aggregated. For clarity, the annual Net Sales Milestone Payments set forth in
Section 6.3(b)(i) (Sales Milestone Payments) shall be payable only once for all
Licensed Products, upon the first achievement of the applicable Milestone Event,
even if the same Milestone Event is later achieved by another Licensed Product.

 

26.

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(iii) If a Milestone Event in Section 6.3(b)(i) (Sales Milestone Payments) is
achieved and payment with respect to any previous Milestone Event has not been
made, then such previous Milestone Event shall be deemed achieved, HanAll shall
invoice Roivant for such unpaid previous Milestone Event(s) and Roivant shall
pay HanAll such unpaid previous Milestone Payment(s) within [*] after receipt of
such invoice.

6.4 Royalty Payments.

(a) Royalty Rate. Subject to the terms and conditions of this Agreement, Roivant
shall make [*], non-refundable, non-creditable royalty payments to HanAll on the
Net Sales of Licensed Products sold in the Territory during the applicable
Royalty Term, as calculated by multiplying the applicable royalty rate set forth
below by the corresponding amount of Net Sales of all Licensed Products sold in
the Territory in the applicable Calendar Year.

 

Annual Net Sales of Licensed Products in the Territory

   Royalty Rate

For that portion of annual Net Sales less than [*]

   [*]

For that portion of annual Net Sales greater than or equal to [*] but less than
[*]

   [*]

For that portion of annual Net Sales greater than or equal to [*] but less than
[*]

   [*]

For that portion of annual Net Sales greater than or equal to [*] but less than
[*]

   [*]

For that portion of annual Net Sales greater than or equal to [*]

   [*]

(b) Royalty Term. Royalties shall be paid on a Licensed Product-by-Licensed
Product and country-by-country basis from the First Commercial Sale of such
Licensed Product in such country in the Territory until the later of
(i) expiration of the last-to-expire Valid Claim of the HanAll Patents that
would, but for the licenses granted hereunder, be infringed by the manufacture,
use or sale of such Licensed Product (or the Compound therein) in such country
in the Territory; (ii) eleven (11) years after the First Commercial Sale of such
Licensed Product in such country; or (iii) expiration of Regulatory Exclusivity
for such Licensed Product in such country (the “Royalty Term” for such Licensed
Product and country).

(c) Royalty Adjustment. Royalties due pursuant to Section 6.4(a) (Royalty Rate)
are subject to adjustment on a country-by-country, Licensed Product-by-Licensed
Product and [*] basis as a result of the events set forth below (such
adjustments to be prorated for the then-current [*] in which the reduction
becomes applicable); provided, however, that the royalties payable under
Section 6.4(a) (Royalty Rate) shall not be reduced by more than [*] of the
amounts set forth in Section 6.4(a) (Royalty Rate) by any or all reasons of the
adjustments set forth below.

 

27.

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(i) Royalty Adjustment for Third Party License Payments. If Roivant, its
Affiliates or Sublicensees, in their reasonable judgment, obtain a license from
a Third Party under any issued patent of such Third Party that Roivant
reasonably believes would be infringed by the making, use, import, offer for
sale, or sale of any Compound in the Field in a particular country in the
Territory, then Roivant may deduct, from the royalty payment that would
otherwise have been due to HanAll on the Net Sales of a Licensed Product
containing such Compound in such country in any [*] an amount equal to [*] of
the amount paid by Roivant, its Affiliate or Sublicensee to such Third Party
pursuant to such license for such Licensed Product in such country in such
Calendar Quarter. The amounts that may be deducted in this section also include
any payments made by Roivant, its Affiliates, or Sublicensees, for Third Party
Licenses pursuant to Section 2.7 (Third Party Licenses), but only to the extent
such payments would be deductible under this Section 6.4(c)(i) (Royalty
Adjustment for Third Party Licensed Payments) if Roivant were a party to the
applicable Third Party License.

(ii) Royalty Adjustment for Non-Patent Products. If, during a particular
Calendar Quarter, (A) a particular Licensed Product is imported, manufactured,
offered for sale, and sold only in a country or countries in which there are no
Valid Claims within the HanAll Patents that would be infringed (absent a license
or ownership of the applicable Valid Claims) by the act or acts that occurred in
such country(ies) and (B) there is no Regulatory Exclusivity for such Licensed
Product in the country of sale, the royalties payable under Section 6.4(a)
(Royalty Rate) on the sale of such Licensed Product in such Calendar Quarter
shall be reduced by [*]. For clarity, such reduction will apply to the sale of a
particular Licensed Product only if none of the above described activities would
infringe (absent a license or ownership) a Valid Claim of a HanAll Patent in the
country in which such activity occurred and there is no Regulatory Exclusivity
for such Licensed Product in the country of sale. Such royalty reduction will be
calculated by determining the portion of total Net Sales of the relevant
Licensed Product in a Calendar Quarter that is attributable to the country in
which such reduction applies, and by determining the total royalties for the
Territory without reduction, and then reducing by [*] the applicable portion
(based on Net Sales) of total royalties attributable to the country in which
such reduction applies.

(iii) Royalty Adjustment for Generic Competition. If there is Generic
Competition for a particular Licensed Product in a particular country in a
particular Calendar Quarter, the royalties payable to HanAll on the sales of
such Licensed Product in such country in such Calendar Quarter shall be reduced
by [*] of the royalty rates set forth in Section 6.4(a) (Royalty Rate). If both
the reduction under Section 6.4(c)(ii) (Royalty Adjustment for Non-Patent
Products) and the reduction under this Section 6.4(c)(iii) (Royalty Adjustment
for Generic Competition) apply, then only the reduction under this
Section 6.4(c)(iii) (Royalty Adjustment for Generic Competition) may be taken.
Such royalty reduction will be calculated by determining the portion of total
Net Sales of the relevant Licensed Product in a Calendar Quarter that is
attributable to the country in which such reduction applies, and by determining
the total royalties for the Territory without reduction, and then reducing by
[*] the applicable portion (based on Net Sales) of total royalties attributable
to the country in which such reduction applies.

 

28.

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7. PAYMENT; RECORDS; AUDITS

7.1 Payment; Reports. Royalty payments due by Roivant to HanAll under
Section 6.4 (Royalty Payments) shall be calculated and reported for each
Calendar Quarter. All royalty payments due under Section 6.4 (Royalty Payments)
shall be paid within [*] after the end of each [*] and shall be accompanied by a
report setting forth, on a country-by-country and Licensed Product-by Licensed
Product basis, Net Sales of Licensed Products by Roivant and its Affiliates and
Sublicensees in the Territory in sufficient detail to permit confirmation of the
accuracy of the royalty payment made, including, for each country, the number of
Licensed Products sold, the gross sales and Net Sales of Licensed Products, the
total amount of the deductions for each category (a)-(f) of Section 1.64 (Net
Sales) to gross sales used to calculate Net Sales, the royalties payable, the
method used to calculate the royalties and the exchange rates used.

7.2 Exchange Rate; Manner and Place of Payment. All references to dollars and
“$” herein shall refer to U.S. dollars. All payments hereunder shall be payable
in U.S. dollars. When conversion of payments from any currency other than U.S.
dollars is required, such conversion shall be at the exchange rate published by
The Wall Street Journal, Western U.S. Edition, on the last day of the Calendar
Quarter in which the applicable sales were made. 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 HanAll, unless otherwise specified in
writing by HanAll.

7.3 Taxes.

(a) Taxes on Income. Except as otherwise set forth in this Section 7.3 (Taxes),
each Party shall be solely responsible for the payment of all taxes imposed on
its share of income arising directly or indirectly from the activities of the
Parties under this Agreement.

(b) Tax Cooperation. The Parties agree to use commercially reasonable efforts to
cooperate with one another and use reasonable efforts to avoid or reduce Tax
withholding or similar obligations in respect of royalties, Milestone Payments,
and other payments made by Roivant to HanAll under this Agreement. If
withholding Taxes are imposed on any such payment, the liability for such taxes
shall be the sole responsibility of HanAll, and Roivant shall (i) deduct or
withhold such Taxes from the payment made to HanAll, (ii) timely pay such Taxes
to the proper taxing authority, and (iii) send proof of payment to HanAll within
[*] following such payment. Each Party shall comply with (or provide the other
Party with) any certification, identification or other reporting requirements
that may be reasonably necessary in order for Roivant to not withhold Tax or to
withhold Tax at a reduced rate under an applicable bilateral income tax treaty.
Each Party shall provide the other with commercially reasonable assistance to
enable the recovery, as permitted by Applicable Laws, of withholding Taxes or
similar obligations resulting from payments made under this Agreement, such
recovery to be for the benefit of HanAll as the Party bearing the cost of such
withholding Tax under this Section 7.3(b) (Tax Cooperation). Notwithstanding the
foregoing, if as a result of any assignment or sublicense by Roivant, any change
in Roivant’s tax residency, any change in the entity that originates the
payment, or any failure on the part of Roivant to comply with Applicable Laws
(including filing or record retention requirements), withholding Taxes are
imposed that were not otherwise applicable (“Incremental

 

29.

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Withholding Taxes”), then Roivant shall be solely responsible for the amount of
such Incremental Withholding Taxes and shall increase the amounts payable to
HanAll so that HanAll receives a sum equal to the sum which it would have
received had there been no such imposition of Incremental Withholding Taxes,
except to the extent that such Incremental Withholding Taxes would not have been
imposed but for the failure of HanAll to comply with any certification,
identification or other reporting requirements if (i) Roivant notifies HanAll of
such requirement sufficiently in advance for HanAll to be able to comply,
(ii) such compliance is required or imposed by Applicable Law as a precondition
to an exemption from, or reduction in, such Incremental Withholding Taxes and
(iii) Roivant reimburses all costs incurred by HanAll to comply with such
requirement.

(c) Transfer Tax. Roivant shall bear and pay any transfer, stamp, value added,
sales, use, or similar Taxes or obligations (“Transfer Tax”) imposed on amounts
payable by Roivant to HanAll in connection with this Agreement. If HanAll is
required by Applicable Laws to directly pay any Transfer Taxes, Roivant shall
indemnify HanAll for such Transfer Taxes and shall promptly reimburse HanAll for
any such Transfer Tax. Roivant shall be responsible for the timely filing of any
Tax returns related to any such Transfer Taxes provided that HanAll shall
cooperate to file any such Tax returns if required by Applicable Laws.

7.4 Records; Audit. Roivant shall keep, and shall cause its Affiliates to keep,
complete and accurate records pertaining to the sale or other disposition of
Licensed Products in sufficient detail to permit HanAll to confirm the accuracy
of sales Milestone Payments and royalty payments due hereunder. Such records
shall be kept for such period of time required by Applicable Laws, but no less
than [*] following the end of the Calendar Quarter to which they pertain. HanAll
shall have the right to cause an independent, certified public accountant
reasonably acceptable to Roivant to audit such records to confirm Net Sales,
royalties and other payments for a period covering not more than [*] following
the Calendar Quarter to which they pertain. Such audits may occur a maximum of
once per Fiscal Year, and may be exercised during normal business hours upon [*]
prior written notice to Roivant. Prompt adjustments shall be made by the Parties
to reflect the results of such audit. HanAll shall bear the full cost of such
audit unless such audit discloses an underpayment by Roivant of more than [*] of
the amount of royalties or other payments due under this Agreement for any
applicable Calendar Quarter, in which case, Roivant shall bear the cost of such
audit and shall promptly remit to HanAll the amount of any underpayment, along
with interest under Section 7.5 (Late Payments). Any overpayment by Roivant
revealed by an audit shall be credited against future payment owed by Roivant to
HanAll (and if no further payments are due, shall be refunded by HanAll at the
request of Roivant). Any period of time may only be audited once.

7.5 Late Payments. In the event that any payment due under this Agreement is not
paid when due in accordance with the applicable provisions of this Agreement,
the payment shall accrue interest from the date due at the rate of [*] per
month; provided, however, that in no event shall such rate exceed the maximum
legal annual interest rate. The payment of such interest shall not limit the
Party entitled to receive payment from exercising any other rights it may have
as a consequence of the lateness of any payment.

 

30.

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8. INTELLECTUAL PROPERTY

8.1 Ownership.

(a) Data. All Data generated in connection with any Development, regulatory,
manufacturing or Commercialization activities with respect to any Compound or
Licensed Product conducted by or on behalf of Roivant or its Affiliates or
Sublicensees (the “Roivant Data”) shall be the sole and exclusive property of
Roivant or of its Affiliates or Sublicensees, as applicable. All Data generated
in connection with any Development, regulatory, manufacturing or
Commercialization activities with respect to any Compound or Licensed Product
conducted by or on behalf of HanAll and its Affiliates and licensees (the
“HanAll Data”) shall be the sole and exclusive property of HanAll or its
Affiliates or licensees, as applicable.

(b) Ownership of Inventions. Ownership of all Inventions shall be based on
inventorship, as determined in accordance with the rules of inventorship under
United States patent laws. Each Party shall solely own any Inventions made
solely by its or its Affiliates’ employees, agents or independent contractors
(“Sole Inventions”). The Parties shall jointly own any Inventions that are made
jointly by employees, agents or independent contractors of one Party or its
Affiliates together with employees, agents or independent contractors of the
other Party or its Affiliates (“Joint Inventions”). All Patents claiming Joint
Inventions shall be referred to herein as “Joint Patents.” Except to the extent
either Party is restricted by the licenses granted to the other Party under this
Agreement, including the license granted in Section 8.1(d) (License to HanAll),
each Party shall be entitled to practice, license, assign and otherwise exploit
the Joint Inventions and Joint Patents without the duty of accounting or seeking
consent from the other Party.

(c) Disclosure of Inventions. Each Party shall promptly disclose to the other
Party all Sole Inventions of such Party that are related to Compounds or
Licensed Products and all Joint Inventions, including any invention disclosures
or other similar documents submitted to such Party by its employees, agents or
independent contractors describing such Inventions, and shall promptly respond
to reasonable requests from the other Party for additional information relating
to such Inventions.

(d) License to HanAll. Subject to the terms and conditions of this Agreement,
Roivant hereby grants to HanAll (i) an exclusive (even as to Roivant),
royalty-free, fully-paid, perpetual, irrevocable license, with the right to
grant sublicenses through multiple tiers, under the Roivant Technology,
including Roivant’s Sole Inventions and Roivant’s rights in Joint Inventions and
Joint Patents, to Develop, make, have made, use, import, offer for sale, sell
and otherwise Commercialize Compounds and Licensed Products outside the
Territory and (ii) a non-exclusive, royalty-free, fully-paid, perpetual,
irrevocable license, with the right to grant sublicenses through multiple tiers,
under the Roivant Technology, including Roivant’s Sole Inventions and Roivant’s
rights in Joint Inventions and Joint Patents, to make and have made Compounds
and Licensed Products in the Territory, solely for the development and
commercialization of Compounds and Licensed Products outside the Territory.
Notwithstanding the foregoing, the licenses in this Section 8.1(d) (License to
HanAll) shall be revocable and terminable in the event of a termination of this
Agreement by Roivant pursuant to Section 12.2(a) (Material Breach) for a
material breach by HanAll; provided that in such event the Parties may negotiate
a license pursuant to Section 12.5(c) (Roivant Technology).

 

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8.2 Patent Prosecution and Maintenance.

(a) Roivant Patents, HanAll Patents and Joint Patents in the Territory.

(i) Subject to this Section 8.2(a) (Roivant Patents, HanAll Patents and Joint
Patents in the Territory), Roivant shall have the sole right, but not the
obligation, to control the preparation, filing, prosecution (including any
interferences, reissue proceedings and reexaminations) and maintenance of all
Roivant Patents (excluding Joint Patents) worldwide; HanAll Patents (excluding
Joint Patents); and Joint Patents in the Territory, at its sole cost and expense
and by counsel of its own choice. Roivant shall consult with HanAll and keep
HanAll reasonably informed of the status of such Roivant Patents (excluding
Joint Patents) worldwide; HanAll Patents (excluding Joint Patents); and Joint
Patents in the Territory and shall promptly provide HanAll with all material
correspondence received from any patent authority in connection therewith. In
addition, Roivant shall promptly provide HanAll with drafts of all proposed
material filings and correspondence to any patent authority with respect to such
Patents worldwide for HanAll’s review and comment prior to the submission of
such proposed filings and correspondence. Roivant shall confer with HanAll and
consider in good faith HanAll’s comments prior to submitting such filings and
correspondence, provided that HanAll provides such comments within [*] (or a
shorter period reasonably designated by Roivant if [*] is not practicable given
the filing deadline) of receiving the draft filings and correspondence from
Roivant. Roivant shall not make any statement or take any action in connection
with its prosecution of the HanAll Patents that may adversely affect the scope
of any HanAll Patent or any Patent of HanAll outside the Territory without the
prior written consent of HanAll.

(ii) In the event that Roivant desires to abandon or cease prosecution or
maintenance of any Roivant Patent (excluding Joint Patents) worldwide; HanAll
Patent (excluding Joint Patents); or Joint Patent in the Territory, Roivant
shall provide reasonable prior written notice to HanAll of such intention to
abandon (which notice shall, to the extent possible, be given no later than [*]
prior to the next deadline for any action that must be taken with respect to any
such Patent in the relevant patent office). In such case, upon HanAll’s written
election provided no later than [*] after such notice from Roivant, HanAll shall
have the right to assume prosecution and maintenance of such Patent at HanAll’s
expense. If HanAll does not provide such election within [*] after such notice
from Roivant, Roivant may, in its sole discretion, continue prosecution and
maintenance of such Patent or discontinue prosecution and maintenance of such
Patent.

(b) Joint Patents Outside the Territory.

(i) Subject to this Section 8.2(b) (Joint Patents Outside the Territory), HanAll
shall have the sole right, but not the obligation, to control the preparation,
filing, prosecution (including any interferences, reissue proceedings and
reexaminations) and maintenance of the Joint Patents outside of the Territory,
at its sole cost and expense and by counsel of its own choice. HanAll shall
consult with Roivant and keep Roivant reasonably informed of the

 

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status of the Joint Patents outside the Territory and shall promptly provide
Roivant with all material correspondence received from any patent authority in
connection therewith. In addition, HanAll shall promptly provide Roivant with
drafts of all proposed material filings and correspondence to any patent
authority with respect to the Joint Patents outside the Territory for Roivant’s
review and comment prior to the submission of such proposed filings and
correspondence. HanAll shall confer with Roivant and consider in good faith
Roivant’s comments prior to submitting such filings and correspondence, provided
that Roivant provides such comments within [*] (or a shorter period reasonably
designated by HanAll if [*] is not practicable given the filing deadline) of
receiving the draft filings and correspondence from HanAll.

(ii) In the event that HanAll desires to abandon or cease prosecution or
maintenance of any Joint Patent outside the Territory, HanAll shall provide
reasonable prior written notice to Roivant of such intention to abandon (which
notice shall, to the extent possible, be given no later than [*] prior to the
next deadline for any action that must be taken with respect to any such Joint
Patent outside the Territory in the relevant patent office). In such case, upon
Roivant’s written election provided no later than [*] after such notice from
HanAll, Roivant shall have the right to assume prosecution and maintenance of
such Joint Patent outside the Territory at Roivant’s expense. If Roivant does
not provide such election within [*] after such notice from HanAll, HanAll may,
in its sole discretion, continue prosecution and maintenance of such Joint
Patent or discontinue prosecution and maintenance of such Joint Patent.

8.3 Cooperation of the Parties. Each Party agrees to cooperate fully in the
preparation, filing, prosecution and maintenance of Patents under Section 8.2
(Patent Prosecution and Maintenance), at its own cost. Such cooperation
includes: (a) executing all papers and instruments, or requiring its employees
or contractors, to execute such papers and instruments, so as enable the other
Party to apply for and to prosecute patent applications in any country as
permitted by Section 8.2 (Patent Prosecution and Maintenance); and (b) promptly
informing the other Party of any matters coming to such Party’s attention that
may affect the preparation, filing, prosecution or maintenance of any such
patent applications.

8.4 Infringement by Third Parties.

(a) Notice. In the event that either HanAll or Roivant becomes aware of any
infringement or threatened infringement by a Third Party of any HanAll Patent,
Roivant Patent or Joint Patent, which infringing activity involves the using,
making, importing, offering for sale or selling of a Licensed Product, or the
submission to a Party or a Regulatory Authority of an application for a product
referencing a Licensed Product, or any declaratory judgment or equivalent action
(including but not limited to an inter partes review before the U.S. Patent and
Trademark Office) challenging any HanAll Patent, Roivant Patent or Joint Patent
in connection with any such infringement (each, a “Product Infringement”), it
will notify the other Party in writing to that effect. Any such notice shall
include evidence to support an allegation of infringement or threatened
infringement, or declaratory judgment or equivalent action, by such Third Party.

 

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(b) HanAll Patents and Joint Patents in the Territory.

(i) Subject to this Section 8.4(b) (HanAll Patents and Joint Patents in the
Territory), Roivant shall have the first right, as between HanAll and Roivant,
but not the obligation, to bring an appropriate suit or take other action
against any person or entity engaged in, or to defend against, a Product
Infringement of any HanAll Patents (including Joint Patents in the Territory),
at its own expense and by counsel of its own choice. HanAll shall have the
right, at its own expense, to be represented in any such action by counsel of
its own choice, and Roivant and its counsel will reasonably cooperate with
HanAll and its counsel in strategizing, preparing and prosecuting any such
action or proceeding. If Roivant fails to bring an action or proceeding with
respect to such Product Infringement of any HanAll Patent (including Joint
Patents in the Territory) within (A) [*] following the notice of alleged
infringement or declaratory judgment or (B) [*] before the time limit, if any,
set forth in the appropriate laws and regulations for the filing of such
actions, whichever comes first, HanAll shall have the right, but not the
obligation, to bring and control any such action at its own expense and by
counsel of its own choice, and Roivant shall have the right, at its own expense,
to be represented in any such action by counsel of its own choice.

(ii) Except as otherwise agreed by the Parties as part of a cost-sharing
arrangement, any recovery or damages realized as a result of such action or
proceeding with respect to HanAll Patents shall be used first to reimburse the
Parties’ documented out-of-pocket legal expenses relating to the action or
proceeding, and any remaining compensatory damages relating to Licensed Products
(including lost sales or lost profits with respect to Licensed Products) shall
be retained by the Party that brought and controlled such action or proceeding,
and in the case that Roivant brought and controlled such action or proceeding,
such remaining compensatory damages shall be deemed to be Net Sales subject to
royalty payments to HanAll in accordance with the royalty provisions of
Section 6.4 (Royalty Payments) and for purpose of commercial Milestone Events
under Section 6.3(b) (Sales Milestone Payments), and any punitive damages shall
be equally shared by the Parties.

(c) Roivant Patents.

(i) Roivant shall have the sole right, as between HanAll and Roivant, but not
the obligation, to bring an appropriate suit or take other action against any
person or entity engaged in, or to defend against, a Product Infringement of any
Roivant Patents (excluding Joint Patents) in the Territory, at its own expense
and by counsel of its own choice. Any recovery or damages realized as a result
of such action or proceeding by Roivant with respect to Roivant Patents
(excluding Joint Patents) in the Territory shall be used first to reimburse
Roivant’s documented out-of-pocket legal expenses relating to the action or
proceeding, and any remaining compensatory damages relating to Licensed Products
(including lost sales or lost profits with respect to Licensed Products) shall
be retained by Roivant, and any punitive damages shall be retained by Roivant.

 

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(ii) Subject to this Section 8.4(c)(ii) (Roivant Patents), HanAll shall have the
first right, as between HanAll and Roivant, but not the obligation, to bring an
appropriate suit or take other action against any person or entity engaged in,
or to defend against, a Product Infringement of any Roivant Patents (excluding
Joint Patents) outside the Territory, at its own expense and by counsel of its
own choice. Roivant shall have the right, at its own expense, to be represented
in any such action by counsel of its own choice, and HanAll and its counsel will
reasonably cooperate with Roivant and its counsel in strategizing, preparing and
prosecuting any such action or proceeding. If HanAll fails to bring an action or
proceeding with respect to such Product Infringement of any Roivant Patent
(excluding Joint Patents) outside the Territory within (A) [*] following the
notice of alleged infringement or declaratory judgment or (B) [*] before the
time limit, if any, set forth in the appropriate laws and regulations for the
filing of such actions, whichever comes first, Roivant shall have the right, but
not the obligation, to bring and control any such action at its own expense and
by counsel of its own choice, and HanAll shall have the right, at its own
expense, to be represented in any such action by counsel of its own choice.
Except as otherwise agreed by the Parties as part of a cost- sharing
arrangement, any recovery or damages realized as a result of such action or
proceeding with respect to Roivant Patents outside the Territory shall be used
first to reimburse the Parties’ documented out-of-pocket legal expenses relating
to the action or proceeding, and any remaining compensatory damages relating to
Licensed Products (including lost sales or lost profits with respect to Licensed
Products) shall be retained by the Party that brought and controlled such action
or proceeding, and any punitive damages shall be equally shared by the Parties.

(d) Joint Patents Outside the Territory. Subject to this Section 8.4(d) (Joint
Patents Outside the Territory), HanAll shall have the first right, as between
HanAll and Roivant, but not the obligation, to bring an appropriate suit or take
other action against any person or entity engaged in, or to defend against, a
Product Infringement of any Joint Patents outside the Territory, at its own
expense and by counsel of its own choice. Roivant shall have the right, at its
own expense, to be represented in any such action by counsel of its own choice,
and HanAll and its counsel will reasonably cooperate with Roivant and its
counsel in strategizing, preparing and prosecuting any such action or
proceeding. If HanAll fails to bring an action or proceeding with respect to
such Product Infringement of any Joint Patent outside the Territory within (A)
[*] following the notice of alleged infringement or declaratory judgment or (B)
[*] before the time limit, if any, set forth in the appropriate laws and
regulations for the filing of such actions, whichever comes first, Roivant shall
have the right, but not the obligation, to bring and control any such action at
its own expense and by counsel of its own choice, and HanAll shall have the
right, at its own expense, to be represented in any such action by counsel of
its own choice. Except as otherwise agreed by the Parties as part of a
cost-sharing arrangement, any recovery or damages realized as a result of such
action or proceeding with respect to Joint Patents outside the Territory shall
be used first to reimburse the Parties’ documented out-of-pocket legal expenses
relating to the action or proceeding, and any remaining compensatory damages
relating to Licensed Products (including lost sales or lost profits with respect
to Licensed Products) shall be retained by the Party that brought and controlled
such action or proceeding, and any punitive damages shall be equally shared by
the Parties.

(e) Cooperation. In the event a Party brings an action in accordance with this
Section 8.4 (Infringement by Third Parties), the other Party shall cooperate
fully, including, if required to bring such action, the furnishing of a power of
attorney or being named as a party to such action.

 

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(f) Other Infringement. HanAll shall have the sole right, but not the
obligation, to bring and control, at its own cost and expense, any legal action
in connection with any infringement of any HanAll Patent that is not a Product
Infringement. Roivant shall have the sole right, but not the obligation, to
bring and control, at its own cost and expense, any legal action in connection
with any infringement of any Roivant Patent that is not a Product Infringement.
With respect to any infringement of a Joint Patent that is not a Product
Infringement, the Parties will confer in good faith to determine a course of
action, provided that each Party shall have the right to bring and control, at
its own cost and expense, any legal action in connection with any infringement
of any Joint Patent that is not a Product Infringement.

8.5 Infringement of Third Party Rights. Each Party shall promptly notify the
other in writing of any allegation by a Third Party that the manufacture,
Development, importation, use, marketing or sale of any Compound or Licensed
Product in the Territory infringes or may infringe the intellectual property
rights of a Third Party. If a Third Party asserts that any of its Patents or
other rights are infringed by the manufacture, Commercialization or Development
by Roivant or its Affiliates of any Licensed Product in the Territory, Roivant
shall have the right but not the obligation to defend against any such
assertions at its sole cost and expense. In the event that Roivant elects not to
defend against such Third Party claims within [*] of learning of same, HanAll
shall have the right, but not the obligation, to defend against such an action.
In any event, the other Party shall cooperate fully and shall provide full
access to documents, information and witnesses as reasonably requested by the
Party defending such action. The Party defending the action will reimburse all
Third Party costs incurred in connection with such requested cooperation.
Notwithstanding the foregoing, the Parties’ rights and obligations under this
Section 8.5 (Infringement by Third Parties), including payment obligations, will
be subject to the terms of Article 10 (Indemnification).

8.6 Consent for Settlement. Neither Party shall unilaterally enter into any
settlement or compromise of any action or proceeding under this Article 8
(Intellectual Property) that would in any manner alter, diminish, or be in
derogation of the other Party’s rights under this Agreement without the prior
written consent of such other Party, which shall not be unreasonably withheld.

8.7 Patent Marking. Roivant shall mark and ensure that its Affiliates mark all
patented Licensed Products they sell or distribute pursuant to this Agreement in
accordance with the applicable patent statutes or regulations in the country or
countries of manufacture and sale thereof.

8.8 Patent Extensions. The Parties shall cooperate in obtaining patent term
restoration, supplemental protection certificates or their equivalents, and
patent term extensions with respect to the HanAll Patents in any country in the
Territory where applicable. Roivant shall file for such extensions at Roivant’s
sole cost and expense.

8.9 Trademarks. Roivant shall own and be responsible for all trademarks, trade
names, branding or logos related to Licensed Products in the Field in the
Territory. Roivant shall be responsible for selecting, registering, prosecuting,
defending, and maintaining all such marks at Roivant’s sole cost and expense.

 

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9. REPRESENTATIONS AND WARRANTIES

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

9.2 Mutual Covenants.

(a) Employees, Consultants and Contractors. Each Party covenants that it has
obtained or will obtain written agreements from each of its employees,
consultants and contractors who perform Development activities pursuant to this
Agreement, which agreements will obligate such persons to obligations of
confidentiality and non-use and to assign Inventions in a manner consistent with
the provisions of this Agreement.

(b) Debarment. Each Party represents, warrants and covenants to the other Party
that it is not debarred or disqualified under the U.S. Federal Food, Drug and
Cosmetic Act, as may be amended, or comparable laws in any country or
jurisdiction other than the U.S., and it does not, and will not during the Term,
employ or use the services of any person who is debarred or disqualified, in
connection with activities relating to any Compound or Licensed Product. In the
event that either Party becomes aware of the debarment or disqualification or
threatened debarment or disqualification of any person providing services to
such Party, including the Party itself or its Affiliates, that directly or
indirectly relate to activities contemplated by this Agreement, such Party shall
immediately notify the other Party in writing and such Party shall cease
employing, contracting with, or retaining any such person to perform any such
services.

(c) Compliance. Each Party covenants as follows:

(i) In the performance of its obligations under this Agreement, such Party shall
comply and shall cause its and its Affiliates’ employees and contractors to
comply with all Applicable Laws, rules and regulations, including all export
control, anti-corruption and anti-bribery laws and regulations, and shall not
cause such other Party’s Indemnitees to be in violation of any Applicable Laws
or otherwise cause any reputational harm to such other Party.

(ii) Such Party and its and its Affiliates’ employees and contractors shall not,
in connection with the performance of their respective obligations under this
Agreement, directly or indirectly through Third Parties, pay, promise or offer
to pay, or authorize the payment of, any money or give any promise or offer to
give, or authorize the giving of anything of value to a Public Official or
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with, or directing business to, any person, including, without limitation,
either Party (and each Party represents and warrants that as of the Effective
Date, such Party, and to its knowledge, its and its Affiliates’ employees and
contractors, have not directly or indirectly promised, offered or provided any
corrupt payment, gratuity, emolument, bribe, kickback, illicit gift or
hospitality or other illegal or unethical benefit to a Public Official or Entity
or any other person in connection with the performance of such Party’s
obligations under this Agreement, and each Party covenants that it and its
Affiliates’ employees and contractors shall not, directly or indirectly, engage
in any of the foregoing).

(iii) Each Party shall have the right to suspend or terminate this Agreement in
its entirety where there is a credible finding, after a reasonable
investigation, that the other Party, in connection with performance of such
other Party’s obligations under this Agreement, has violated any anti-corruption
or anti-bribery laws or regulations.

9.3 Additional HanAll Representations, Warranties and Covenants. HanAll
represents, warrants and covenants, as applicable, to Roivant that, as of the
Effective Date:

(a) Exhibit C lists all Patents owned or Controlled by HanAll in the Territory
as of the Effective Date that claim the composition of matter or use of
HL161BKN;

(b) HanAll has not received any written notice or, to its knowledge, any other
notice, from a Third Party that the Development of any Compound or Licensed
Product conducted by HanAll prior to the Effective Date has infringed any
Patents of any Third Party or misappropriated any other intellectual property of
any Third Party, and HanAll is not aware that any Third Party intends to make
any threat of such infringement or misappropriation;

(c) HanAll has not as of the Effective Date, and will not during the Term, grant
any right to any Third Party under the HanAll Technology that would conflict
with the rights granted to Roivant hereunder;

(d) HanAll has no knowledge as of the Effective Date of any Third Party that is
infringing any issued HanAll Patent or misappropriating any HanAll Know-How in
the Territory; and

(e) no claim or action has been brought or, to HanAll’s knowledge, threatened in
writing by any Third Party alleging that the HanAll Patents are invalid or
unenforceable, and no HanAll Patent is the subject of any interference,
opposition, cancellation or other protest proceeding.

9.4 Additional Roivant Representations, Warranties and Covenants. Roivant
represents, warrants and covenants to HanAll that, as of the Effective Date,
Roivant has not granted, and will not grant during the Term, any right to any
Third Party under the Roivant Technology that would conflict with the rights
granted to HanAll hereunder.

 

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9.5 Disclaimer. Except as expressly set forth in this Agreement, THE TECHNOLOGY
AND INTELLECTUAL PROPERTY RIGHTS PROVIDED BY EACH PARTY HEREUNDER ARE PROVIDED
“AS IS” AND EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES OF ANY KIND,
EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF DESIGN, MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF
THIRD PARTIES, OR ARISING FROM A COURSE OF DEALING, USAGE OR TRADE PRACTICES, IN
ALL CASES WITH RESPECT THERETO. Without limiting the foregoing, neither Party
represents or warrants the success of any study or test conducted by pursuant to
this Agreement or the safety or usefulness for any purpose of the technology it
provides hereunder or any Compound or Licensed Product.

10. INDEMNIFICATION

10.1 Indemnification by HanAll. HanAll hereby agrees to defend, indemnify and
hold harmless Roivant and its Affiliates and their respective directors,
officers, employees and agents (each, an “Roivant Indemnitee”) from and against
any and all liabilities, expenses and losses, including reasonable legal
expenses and attorneys’ fees (collectively, “Losses”), to which any Roivant
Indemnitee may become subject as a result of any claim, demand, action or other
proceeding by any Third Party to the extent such Losses arise out of: (a) the
Development, manufacture, use, handling, storage, sale, disposition or other
Commercialization of any Compound or Licensed Product by HanAll or its
Affiliates outside the Territory; (b) the negligence or willful misconduct of
any HanAll Indemnitee, or (c) the breach by HanAll of any warranty,
representation, covenant or agreement made by HanAll in this Agreement; except,
in each case of subsections (a), (b),and (c), to the extent such Losses arise
out of the negligence or willful misconduct of any Roivant Indemnitee or the
breach by Roivant of any warranty, representation, covenant or agreement made by
Roivant in this Agreement.

10.2 Indemnification by Roivant. Roivant hereby agrees to defend, indemnify and
hold harmless HanAll and its Affiliates and their respective directors,
officers, employees and agents (each, a “HanAll Indemnitee”) from and against
any and all Losses to which any HanAll Indemnitee may become subject as a result
of any claim, demand, action or other proceeding by any Third Party to the
extent such Losses arise out of: (a) the Development, manufacture, use,
handling, storage, sale, disposition or other Commercialization of any Compound
or Licensed Product by Roivant or its Affiliates in the Territory, (b) the
negligence or willful misconduct of any Roivant Indemnitee, or (c) the breach by
Roivant of any warranty, representation, covenant or agreement made by Roivant
in this Agreement; except, in each case of subsections (a), (b) and (c), to the
extent such Losses arise out of the negligence or willful misconduct of any
HanAll Indemnitee or the breach by HanAll of any warranty, representation,
covenant or agreement made by HanAll in this Agreement.

10.3 Procedure. A party that intends to claim indemnification under this Article
10 (Indemnification) (the “Indemnitee”) shall promptly notify the indemnifying
Party (the “Indemnitor”) in writing of any Third Party claim, demand, action or
other proceeding (each, a “Claim”) in respect of which the Indemnitee intends to
claim such indemnification, and the Indemnitor shall have sole control of the
defense or settlement thereof. The Indemnitee may participate at its expense in
the Indemnitor’s defense of and settlement negotiations for any Claim with
counsel of the Indemnitee’s own selection. The indemnity arrangement in this
Article 10 (Indemnification) shall not apply to amounts paid in settlement of
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Claim, if such settlement is effected without the consent of the Indemnitor,
which consent shall not be withheld or delayed unreasonably. The failure to
deliver written notice to the Indemnitor within a reasonable time after the
commencement of any action with respect to a Third Party Claim shall only
relieve the Indemnitor of its indemnification obligations under this Article 10
(Indemnification) if and to the extent the Indemnitor is actually prejudiced
thereby. The Indemnitee shall cooperate fully with the Indemnitor and its legal
representatives in the investigation of any action with respect to a Claim
covered by this indemnification.

10.4 Insurance. Each Party, at its own expense, shall maintain product liability
and other appropriate insurance (or self-insure) in an amount consistent with
sound business practice and reasonable in light of its obligations under this
Agreement during the Term. Each Party shall provide a certificate of insurance
(or evidence of self-insurance) evidencing such coverage to the other Party upon
request.

11. CONFIDENTIALITY

11.1 Confidential Information. Except to the extent expressly authorized by this
Agreement or otherwise agreed in writing by the Parties, the Parties agree that,
during the Term and for seven (7) years thereafter, the receiving Party shall
keep confidential and shall not publish or otherwise disclose and shall not use
for any purpose other than as expressly provided for in this Agreement any
Confidential Information of the other Party under to this Agreement, and both
Parties shall keep confidential and, subject to Sections 11.2 (Exceptions) and
11.3 (Authorized Disclosure) and 11.4 (Publications) and 11.5 (Publicity; Public
Disclosures), shall not publish or otherwise disclose the terms of this
Agreement. Each Party may use the other Party’s Confidential Information only to
the extent required to accomplish the purposes of this Agreement, including
exercising its rights or performing its obligations. Each Party will use at
least the same standard of care as it uses to protect proprietary or
confidential information of its own (but no less than reasonable care) to ensure
that its employees, agents, consultants, contractors and other representatives
do not disclose or make any unauthorized use of the Confidential Information of
the other Party. Each Party will promptly notify the other upon discovery of any
unauthorized use or disclosure of the Confidential Information of the other
Party.

11.2 Exceptions. The obligations of confidentiality and restriction on use under
Section 11.1 (Confidential Information) will not apply to any information that
the receiving Party can prove by competent written evidence: (a) is now, or
hereafter becomes, through no act or failure to act on the part of the receiving
Party, generally known or available to the public; (b) is known by the receiving
Party at the time of receiving such information, other than by previous
disclosure of the disclosing Party, or its Affiliates, employees, agents,
consultants, or contractors; (c) is hereafter furnished to the receiving Party
without, to the knowledge of the receiving Party, restriction by a Third Party
who has no obligation of confidentiality or limitations on use with respect
thereto, as a matter of right; or (d) is independently discovered or developed
by the receiving Party without the use of Confidential Information belonging to
the disclosing Party.

 

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11.3 Authorized Disclosure. Each Party may disclose Confidential Information
belonging to the other Party as expressly permitted by this Agreement or if and
to the extent such disclosure is reasonably necessary in the following
instances:

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

 

(b) regulatory filings for Licensed Products that such Party has a license or
right to Develop hereunder in a given country or jurisdiction;

 

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

 

(d) complying with applicable court orders or governmental regulations; and

 

(e) disclosure to its and its Affiliates’ employees, consultants, contractors
and agents, and to licensees (in the case of HanAll), in each case on a
need-to-know basis in connection with the Development, manufacture and
Commercialization of Compounds and Licensed Products in accordance with the
terms of this Agreement under written obligations of confidentiality and non-use
at least as stringent as those herein;

(f) disclosure to potential and actual investors, acquirors, licensees and other
financial or commercial partners of a Party or its applicable Affiliates solely
for the purpose of evaluating or carrying out an actual or potential investment,
acquisition, collaboration, public offering, or merger or sale of substantially
all of such Party’s business to which this Agreement relates, provided that any
such Third Party is under written obligations of confidentiality and non-use at
least as stringent as those herein (except to the extent that a shorter
confidentiality period is customary in the industry); and

(g) disclosure to a Third Party licensor as required under the applicable
license agreement.

Notwithstanding the foregoing, in the event a Party is required to make a
disclosure of the other Party’s Confidential Information pursuant to
Section 11.3(c) (Authorized Disclosure—Subsection (c)) or (d) (Authorized
Disclosure—Subsection (d)), it will, except where impracticable, give reasonable
advance notice to the other Party of such disclosure and use efforts to secure
confidential treatment of such Confidential Information at least as diligent as
such Party would use to protect its own confidential information, but in no
event less than reasonable efforts. In any event, the Parties agree to take all
reasonable action to avoid disclosure of Confidential Information hereunder. Any
information disclosed pursuant to Section 11.3(c) (Authorized
Disclosure—Subsection (c)) or (d) (Authorized Disclosure—Subsection (d)) shall
remain Confidential Information and subject to the restrictions set forth in
this Agreement, including the foregoing provisions of this Article 11
(Confidentiality).

11.4 Publications. Neither Party shall disclose or publish any results of or
other information regarding its Development activities with respect to any
Compound or Licensed Product, whether by oral presentation, poster, manuscript
or abstract, without the prior written consent of the other Party, which shall
not be unreasonably withheld, conditioned or delayed. At least thirty (30) days
before any such material is submitted for publication or presented, the Party
seeking to make the publication or presentation shall deliver a complete copy of
the applicable manuscript, abstract, poster or presentation to the other Party.
The other Party shall review any such material and give its comments and consent
for publication or presentation to the publishing or presenting Party, or shall
notify such Party that it does not consent to such publication or

 

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presentation, within such [*] period. The publishing or presenting Party shall
delete references to the other Party’s Confidential Information in any such
material and, if the other Party reasonably requests, shall delay any submission
for publication or other public disclosure for the purpose of preparing and
filing appropriate patent applications.

11.5 Publicity; Public Disclosures. Each Party may issue a press release
announcing the entry into this Agreement, in a form agreed by the other Party
prior to the Effective Date, on or after the Effective Date. Neither Party shall
issue any other press release, individual or joint, relating to this Agreement
or activities hereunder without the consent of the other Party, which shall not
be unreasonably withheld, conditioned or delayed. Notwithstanding the foregoing,
either Party may make disclosures to securities exchanges or other applicable
agencies (including any such disclosures or filings that are publicly available)
as it determines, based on advice of counsel, are necessary to comply with laws
or regulations or for appropriate market disclosure. Each Party shall provide
the other Party with advance notice of such disclosures (unless such advance
notice is not practicable, in which event the notice will be provided as soon
after disclosure as practicable). The Parties will consult with each other on
the provisions of this Agreement to be redacted in any public filings made by a
Party as required by Applicable Laws; provided, that each Party shall have the
right to make any such filing as it determines, based on advice of counsel, is
necessary under Applicable Laws. Either Party shall be free to disclose, without
the other Party’s prior written consent, the existence of this Agreement, the
identity of the other Party and those terms of the Agreement which have already
been publicly disclosed in accordance herewith. Each Party shall have the right
to name the other Party as a partner, by company name and logo, on such Party’s
website and in corporate overviews and collateral materials.

11.6 Prior Confidentiality Agreement. As of the Effective Date, the terms of
this Article 11 (Confidentiality) shall supersede any prior non-disclosure,
secrecy or confidentiality agreement between the Parties (or their Affiliates)
relating to the subject of this Agreement, including the Confidentiality
Agreement. Any information disclosed pursuant to any such prior agreement shall
be deemed Confidential Information for purposes of this Agreement.

11.7 Equitable Relief. Given the nature of the Confidential Information and the
competitive damage that a Party would suffer upon unauthorized disclosure, use
or transfer of its Confidential Information to any Third Party, the Parties
agree that monetary damages may not be a sufficient remedy for any breach of
this Article 11 (Confidentiality). In addition to all other remedies, a Party
shall be entitled to seek specific performance and injunctive and other
equitable relief as a remedy for any breach or threatened breach of this Article
11 (Confidentiality).

12. TERM AND TERMINATION

12.1 Term. This Agreement shall commence on the Effective Date and, unless
terminated earlier as provided in this Article 12 (Term and Termination) or by
mutual written agreement of the Parties, shall continue on a Licensed
Product-by-Licensed Product basis until the expiration of the last Royalty Term
for such Licensed Product in the Territory (the “Term”). Upon expiration (but
not termination) of this Agreement with respect to any Licensed Product,
Roivant’s licenses under Section 2.1 (Licenses Granted to Roivant; Sublicenses)
with respect to such Licensed Product will become non-exclusive, fully paid-up
and royalty free.

 

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12.2 Termination for Cause.

(a) Material Breach. Each Party shall have the right to terminate this Agreement
in its entirety upon written notice to the other Party if such other Party
materially breaches this Agreement and has not cured such breach within sixty
(60) days (thirty (30) days with respect to any payment breach) after notice of
such breach from the non-breaching Party.

(b) Diligence Breach. If Roivant fails to comply with its obligations under
Section 4.9 (Diligence Obligations) and such failure persists during a [*]
period, then HanAll may terminate this Agreement immediately upon written notice
to Roivant. If at any time HanAll believes in good faith that Roivant is not
complying with its obligations under Section 4.9 (Diligence Obligations), HanAll
may provide written notice of such belief to Roivant, and Roivant will have [*]
to provide to HanAll any information in Roivant’s Control reasonably
demonstrating to HanAll that Roivant is complying with such obligations. If
HanAll notifies Roivant within [*] after HanAll has received such information
that HanAll still in good faith believes that Roivant is not complying with such
obligations, then unless Roivant cures such breach within [*] after receipt of
such notice from HanAll, either Party may refer the dispute to arbitration
pursuant to Section 13.3 (Arbitration). For clarity, this Section 12.2(b)
(Diligence Breach) is in addition to the remedies available to HanAll under
Section 12.2(a) (Material Breach).

(c) Bankruptcy. Each Party shall have the right to terminate this Agreement in
its entirety upon written notice to the other Party if such other Party makes a
general assignment for the benefit of creditors, files an insolvency petition in
bankruptcy, petitions for or acquiesces in the appointment of any receiver,
trustee or similar officer to liquidate or conserve its business or any
substantial part of its assets, commences under the laws of any jurisdiction any
proceeding involving its insolvency, bankruptcy, reorganization, adjustment of
debt, dissolution, liquidation or any other similar proceeding for the release
of financially distressed debtors or becomes a party to any proceeding or action
of the type described above and such proceeding is not dismissed within[*] after
the commencement thereof.

12.3 Termination for Patent Challenge. HanAll shall have the right to terminate
this Agreement in its entirety upon written notice to Roivant if Roivant or any
of its Affiliates directly, or indirectly through any Third Party, commences any
interference or opposition proceeding with respect to, challenges the validity
or enforceability of, or opposes any extension of or the grant of a
supplementary protection certificate with respect to, any HanAll Patent.

12.4 Termination by Roivant. If Roivant desires to terminate this Agreement
other than pursuant to Section 12.2 (Termination for Cause), then Roivant shall
notify HanAll, and the Parties shall discuss in good faith for a period of at
least thirty (30) days Roivant’s reasons for desiring such termination. If
Roivant thereafter still desires to terminate this Agreement, then Roivant shall
have the right to terminate this Agreement upon one hundred eighty (180) days
written notice to HanAll. If Roivant is running any clinical trials at the time
it provides written notice of termination, then the one hundred eighty (180) day
wind-down period set forth in Section 12.5(e) (Wind-Down) shall run concurrent
with the one hundred eighty (180) day notice period in this Section 12.4
(Termination by Roivant).

 

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12.5 Effects of Termination. Upon any termination of this Agreement by either
Party pursuant to Section 12.2 (Termination for Cause), 12.3 (Termination for
Patent Challenge) or 12.4 (Termination by Roivant), the following will apply:

(a) Termination of Licenses and Other Rights. All licenses granted to Roivant
will automatically terminate, all other rights and obligations of the Parties
under this Agreement will terminate, except as expressly provided in this
Section 12.5 (Effects of Termination) and in Section 12.7 (Survival), and all
sublicenses under the HanAll Technology granted by Roivant will automatically
terminate, in each case on the effective date of termination.

(b) Regulatory Filings. Roivant shall: (i) to the extent not previously provided
to HanAll, deliver to HanAll true, correct and complete copies of all Regulatory
Filings (including Regulatory Approvals) for Licensed Products in the Field in
the Territory, and provide to HanAll all Roivant Know-How (including Roivant
Data) not previously disclosed to HanAll; (ii) and hereby does, effective upon
such termination, transfer and assign, or cause to be transferred or assigned,
to HanAll or its designee (or to the extent not so assignable, take all
reasonable actions to make available to HanAll or its designee the benefits of)
all Regulatory Filings (including Regulatory Approvals) for Licensed Products in
the Field in the Territory, whether held in the name of Roivant or its
Affiliate; and (iii) take such other actions and execute such other instruments,
assignments and documents as may be necessary to effect, evidence, register and
record the transfer, assignment or other conveyance of rights under this
Section 12.5(b) (Regulatory Filings) to HanAll. In addition, at HanAll’s
request, Roivant shall provide HanAll with reasonable assistance, at no cost to
HanAll, with any inquiries and correspondence with Regulatory Authorities
regarding any Licensed Product for a period of one (1) year after termination.

(c) Roivant Technology. If the Agreement is terminated by HanAll pursuant to
Sections 12.2 (Termination for Cause) or 12.3 (Termination for Patent Challenge)
or by Roivant pursuant to Section 12.4 (Termination by Roivant), Roivant hereby
grants to HanAll, effective upon such termination, an exclusive (even as to
Roivant), royalty-free, fully-paid, perpetual, irrevocable license, with the
right to grant sublicenses through multiple tiers, under the Roivant Technology
to Develop, make, have made, use, import, offer for sale, sell and otherwise
Commercialize Compounds and Licensed Products in and outside the Territory. If
the Agreement is terminated by Roivant pursuant to Section 12.2 (Termination for
Cause), HanAll may request, within [*] of termination, that Roivant enter into
good faith negotiations for no more than [*] concerning the terms of an
agreement with HanAll granting HanAll a license under the Roivant Technology. If
no agreement is reached during such [*] period, then the Parties will submit the
dispute for resolution pursuant to Section 13.4 (License Terms Determination).
and will enter into an agreement containing agreed terms and any terms
determined pursuant to such dispute resolution.

(d) Marks. Roivant shall, and hereby does, effective on such termination, assign
to HanAll all of Roivant’s and its Affiliates’ right, title and interest in and
to any and all trademarks used by Roivant and its Affiliates in the Territory in
connection with its Development, manufacture or Commercialization of Licensed
Products (excluding any such trademarks that include, in whole or part, any
corporate name or logo of Roivant or its Affiliate), including all goodwill
therein, and Roivant shall promptly take such actions and execute such
instruments, assignments and documents as may be necessary to effect, evidence,
register and record such assignment.

 

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(e) Wind-Down. If at the time of termination, Roivant is conducting any clinical
trials for any Licensed Products, then, at HanAll’s election on a trial-by-trial
basis: (i) Roivant shall fully cooperate with HanAll to transfer the conduct of
such clinical trial to HanAll, [*] or (ii) Roivant shall, at its expense,
orderly wind down the conduct of any such clinical trial that is not assumed by
HanAll upon termination under clause (i), in the case of each of clauses (i) and
(ii) in accordance with applicable Laws.

(f) Transition Assistance. Roivant shall reasonably cooperate with HanAll to
ensure an orderly transition of the Development, manufacture and
Commercialization of Licensed Products to HanAll. Without limiting the
foregoing, Roivant shall provide reasonable consultation and assistance for the
purpose of transferring or transitioning to HanAll all Roivant Know-How not
already in HanAll’s possession and, at HanAll’s request, all then-existing
commercial arrangements relating specifically to any Compound or Licensed
Product that Roivant is able, using reasonable efforts, to transfer or
transition to HanAll, in each case, to the extent reasonably necessary or useful
for HanAll to continue Developing, manufacturing, or Commercializing any
Licensed Product in the Territory. The foregoing shall include transferring,
upon request of HanAll, any agreements with Third Party suppliers or vendors
that specifically cover the supply or sale of any Compound or Licensed Product
in the Territory; provided that if any such contract between Roivant and a Third
Party is not assignable to HanAll (whether by such contract’s terms or because
such contract does not relate specifically to any Compound or Licensed Product)
but is otherwise reasonably necessary or useful for HanAll to commence
Developing, manufacturing, or Commercializing any Licensed Product in the
Territory, or if Roivant or its Affiliate manufactures any Compound or Licensed
Product itself (and thus there is no contract to assign), then Roivant shall
reasonably cooperate with HanAll to negotiate for the continuation of services
or supply from such entity, or Roivant shall supply such Compound or Licensed
Product, as applicable, to HanAll for a reasonable period (not to exceed [*]
until HanAll establishes an alternate, validated source of such services or
supply of finished, packaged, labeled Licensed Product for the Territory. HanAll
shall pay Roivant for such supply from Roivant at a price equal to Roivant’s
cost plus [*]. Roivant shall provide such assistance at no cost to HanAll. In
addition, upon HanAll’s request, Roivant shall provide HanAll with reasonable
technical assistance of up to [*] at no cost to HanAll and any additional hours
at a reasonable hourly rate to be agreed by the Parties, including making
appropriate personnel available to HanAll, for the purpose of assisting HanAll
to understand and use the Roivant Technology to further Develop, manufacture and
Commercialize Licensed Products.

(g) Remaining Inventories. Roivant shall promptly deliver to HanAll an inventory
list of all Compounds and Licensed Products then in its (or its Affiliates’)
possession or control. HanAll shall have the right to purchase from Roivant any
or all of the inventory of Compounds or Licensed Products held by Roivant or its
Affiliates as of the effective date of termination, at a price equal to
Roivant’s cost to acquire or manufacture such inventory, provided that such
inventory complies with specifications and has been manufactured in compliance
with all applicable Laws, including cGMP. HanAll shall notify Roivant within [*]
after the effective date of termination whether it elects to exercise such
rights.

 

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(h) Publicity. In the event of termination of this Agreement for any reason, any
public disclosure of such termination and the reasons therefor shall be governed
by Section 11.5 (Publicity; Public Disclosures).

12.6 Confidential Information. Upon expiration or termination of this Agreement
in its entirety, except to the extent that a Party obtains or retains the right
to use the other Party’s Confidential Information, each Party shall promptly
return to the other Party, or delete or destroy, all relevant records and
materials in such Party’s possession or control containing Confidential
Information of the other Party; provided that such Party may keep one (1) copy
of such materials for archival purposes only subject to continuing
confidentiality obligations. For clarity, such Confidential Information of
HanAll includes all HanAll Know-How and HanAll Data. In addition, within [*]
after the termination of this Agreement, Roivant shall return to HanAll all
Materials, along with all progeny and derivatives thereof and all materials that
could not have been made without access to the Materials.

12.7 Survival. Expiration or termination of this Agreement shall not relieve the
Parties of any obligation or right accruing prior to such expiration or
termination. Except as set forth below or elsewhere in this Agreement, the
obligations and rights of the Parties under the following provisions of this
Agreement shall survive expiration or termination of this Agreement: Articles 1
(Definition), 10 (Indemnification), 11 (Confidentiality) (except for
Section 11.4 (Publications)), 13 (Dispute Resolution), and 14 (General
Provisions); Sections 7.3 (Taxes), 7.4 (Records; Audit), 7.5 (Late Payments),
8.1(a) (Data), 8.1(b) (Ownership of Inventions), 9.5 (Disclaimer), 12.5 (Effects
of Termination), 12.6 (Confidential Information), 12.7 (Survival) and 12.9
(Exercise of Right to Terminate).

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

 

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hereafter existing at law or in equity (including, without limitation, the
Bankruptcy Laws) in the event of the commencement of a case by or against a
Party under the Bankruptcy Laws. In particular, it is the intention and
understanding of the Parties to this Agreement that the rights granted to the
Parties under this Section 12.8 (Rights Upon Bankruptcy) are essential to the
Parties’ respective businesses and the Parties acknowledge that damages are not
an adequate remedy if a case is commenced by or against a Party under the
Bankruptcy Laws during the Term.

12.9 Exercise of Right to Terminate. The use by either Party hereto of a
termination right provided for under this Agreement shall not give rise to the
payment of damages or any other form of compensation or relief to the other
Party with respect thereto; provided, however, that termination of this
Agreement shall not preclude either Party from claiming any other damages,
compensation or relief that it may be entitled to upon such termination.

13. DISPUTE RESOLUTION

13.1 Objective. The Parties recognize that disputes as to matters arising under
or relating to this Agreement or either Party’s rights and obligations hereunder
may arise from time to time. It is the objective of the Parties to establish
procedures to facilitate the resolution of such disputes in an expedient manner
by mutual cooperation and without resort to litigation. To accomplish this
objective, the Parties agree to follow the procedures set forth in this Article
13 (Dispute Resolution) to resolve any such dispute if and when it arises.

13.2 Resolution by Executive Officers. Except as otherwise provided in Article 3
(Governance), if an unresolved dispute as to matters arising under or relating
to this Agreement or either Party’s rights and obligations hereunder arises,
either Party may refer such dispute to the Executive Officers, who shall meet in
person within [*] after such referral to attempt in good faith to resolve such
dispute. If such matter cannot be resolved by discussion of such officers within
such [*] period, or such other time period as the Parties may agree in writing,
such dispute shall be resolved in accordance with Section 13.3 (Arbitration).

13.3 Arbitration.

(a) If the Parties do not resolve a dispute as provided in Section 13.2
(Resolution by Executive Officers), and a Party wishes to pursue the matter,
each such dispute that is not an Excluded Claim (defined below) shall be
resolved by binding arbitration in accordance with the Arbitration Rules of the
International Centre for Dispute Resolution as then in effect (the “Rules”),
which Rules are deemed to be incorporated by reference into this clause, and
judgment on the arbitration award may be entered in any court having
jurisdiction thereof. The decision rendered in any such arbitration will be
final and not appealable.

(b) The arbitration shall be conducted by a panel of three (3) arbitrators
appointed in accordance with the Rules, none of whom shall be a current or
former employee or director, or a then-current stockholder, of either Party or
their respective Affiliates. The seat, or legal place, of arbitration shall be
New York City, New York, and the language of the arbitration will be English.

 

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(c) It is the intention of the Parties that discovery, although permitted as
described herein, will be limited except in exceptional circumstances. The
arbitrators will permit such limited discovery necessary for an understanding of
any legitimate issue raised in the arbitration, including the production of
documents. No later than [*] after selection of the arbitrators, the Parties and
their representatives shall hold a preliminary meeting with the arbitrators, to
mutually agree upon and thereafter follow procedures seeking to assure that the
arbitration will be concluded within [*] from such meeting. Failing any such
mutual agreement, the arbitrators will design and the Parties shall follow
procedures to such effect.

(d) 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. The arbitrators shall have no authority to award punitive or
any other non- compensatory damages, except as may be permitted by Section 14.10
(Limitation of Liability). The arbitrators shall have the power to order that
all or part of the legal or other costs incurred by a Party in connection with
the arbitration be paid by the other Party. Each Party shall bear an equal share
of the arbitrators’ and any administrative fees of arbitration.

(e) Except to the extent necessary to confirm or enforce an award or as may be
required by Applicable Law, neither a Party nor an arbitrator may disclose the
existence, content, or results of an arbitration without the prior written
consent of both Parties. In no event shall an arbitration be initiated after the
date when commencement of a legal or equitable proceeding based on the dispute,
controversy or claim would be barred by the applicable New York statute of
limitations.

(f) As used in this Section 13.3 (Arbitration), the term “Excluded Claim” means
a dispute, controversy or claim that concerns (i) the validity, enforceability
or infringement of a patent, trademark or copyright; or (ii) any antitrust,
anti-monopoly or competition law or regulation, whether or not statutory.

13.4 License Terms Determination.

(a) If the Parties fail to agree on all terms of a license agreement pursuant to
Section 12.5(c) (Roivant Technology) within the applicable [*] period, then the
unresolved terms shall be finally settled by a panel of three (3) impartial and
independent Third Parties acting as experts, and not as arbitrators (the
“Experts”).

(b) Each Expert shall be an expert in the field of pharmaceutical product
licensing as mutually agreed by the Parties in good faith. Before accepting
appointment, each Expert shall disclose to the Parties any circumstances that
might give rise to a reasonable basis for questioning the Expert’s impartiality
or independence, or confirm in writing that no such circumstances exist. If the
Parties are unable to agree on three Experts within [*] of the expiry of the
applicable [*] period, then each Party will select one Expert and the two
Experts will select the third Expert.

 

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(c) Within [*] following the selection of the Experts, each Party shall prepare
and submit to each of the Experts and the other Party a written report setting
forth its position with respect to the unresolved terms of the license. Each
Party shall have ten (10) Business Days from receipt of the other Party’s
submission to submit a written response thereto. The Experts shall have the
right to meet with the Parties, either alone or together.

(d) The Experts shall select one Party’s position as their decision and shall
not have authority to render any substantive decision other than to so select
the terms proposed by either Party. No later than [*] after the designation of
the Experts, the Experts shall make a determination, which will be made by
selecting the terms proposed by one of the Parties that as a whole are the most
fair and reasonable to the Parties in light of the totality of the circumstances
and most accurately reflect industry norms for a transaction of this type. The
Experts shall provide the Parties with a written statement setting forth the
basis of the determination in connection therewith. The Parties agree that such
Experts’ determination shall be final and determinative except that if the
Experts are asked to determine the royalty rate, then the rate will be one and
one-half times the rate determined by the Experts to reflect HanAll’s material
breach of the Agreement (though the Parties will not inform the Experts of this
fact prior to any decision). The Party against whom the Experts rule shall bear
all costs of the Experts .

14. GENERAL PROVISIONS

14.1 Governing Law. This Agreement, and all questions regarding the existence,
validity, interpretation, breach or performance of this Agreement, shall be
governed by, and construed and enforced in accordance with, the laws of the
State of New York, United States, without reference to its conflicts of law
principles, with the exception of sections 5-1401 and 5- 1402 of New York
General Obligations Law. The United Nations Conventions on Contracts for the
International Sale of Goods shall not be applicable to this Agreement.

14.2 Entire Agreement; Modification. This Agreement is both a final expression
of the Parties’ agreement and a complete and exclusive statement with respect to
all of its terms. This Agreement supersedes all prior and contemporaneous
agreements and communications, whether oral, written or otherwise, concerning
any and all matters contained herein. This Agreement may only be modified or
supplemented in a writing expressly stated for such purpose and signed by the
Parties to this Agreement.

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

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

 

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14.5 Assignment. Except as expressly provided hereunder, neither this Agreement
nor any rights or obligations hereunder may be assigned or otherwise transferred
by either Party without the prior written consent of the other Party (which
consent shall not be unreasonably withheld); provided, however, that either
Party may assign or otherwise transfer this Agreement and its rights and
obligations (or a portion thereof) hereunder without the other Party’s consent:
(a) in connection with the transfer or sale of all or substantially all of the
business or assets of such Party relating to Licensed Products to a Third Party,
whether by merger, consolidation, divesture, restructure, sale of stock, sale of
assets or otherwise; provided that in the event of any such transaction (whether
this Agreement is actually assigned or is assumed by the acquiring party by
operation of law (e.g., in the context of a reverse triangular merger)),
intellectual property rights of the acquiring party to such transaction (if
other than one of the Parties to this Agreement) and its Affiliates existing
prior to the transaction shall not be included in the technology licensed
hereunder; and (b) to an Affiliate, provided that the assigning Party shall
remain liable and responsible to the non-assigning Party hereto for the
performance and observance of all such duties and obligations by such Affiliate.
Each Party shall promptly notify the other Party of any such permitted
assignment. The rights and obligations of the Parties under this Agreement shall
be binding upon and inure to the benefit of the successors and permitted assigns
of the Parties, and the name of a Party appearing herein will be deemed to
include the name of such Party’s successors and permitted assigns to the extent
necessary to carry out the intent of this section. Any assignment not in
accordance with this Section 14.5 (Assignment) shall be null and void.

14.6 Performance by Affiliates. Each Party may discharge any obligations and
exercise any rights hereunder through any of its Affiliates. Each Party hereby
guarantees the performance by its Affiliates of such Party’s obligations under
this Agreement, and shall cause its Affiliates to comply with the provisions of
this Agreement in connection with such performance. Any breach by a Party’s
Affiliate of any of such Party’s obligations under this Agreement shall be
deemed a breach by such Party, and the other Party may proceed directly against
such Party without any obligation to first proceed against such Party’s
Affiliate.

14.7 Severability. If, for any reason, any part of this Agreement is adjudicated
invalid, unenforceable or illegal by a court of competent jurisdiction, such
adjudication shall not, to the extent feasible, affect or impair, in whole or in
part, the validity, enforceability, or legality of any remaining portions of
this Agreement. All remaining portions shall remain in full force and effect as
if the original Agreement had been executed without the invalidated,
unenforceable or illegal part.

14.8 Notices. Any notice to be given under this Agreement must be in writing and
delivered either (a) in person, (b) by air mail (postage prepaid) requiring
return receipt, (c) by overnight courier, or (d) by facsimile confirmed
thereafter by any of the foregoing, to the Party to be notified at its
address(es) given below, or at any address such Party may designate by prior
written notice to the other in accordance with this Section 14.8 (Notices).
Notice shall be deemed sufficiently given for all purposes upon the earliest of:
(i) the date of actual receipt; (ii) if air mailed, [*] after the date of
postmark; (iii) if delivered by overnight courier, the next day the overnight
courier regularly makes deliveries or (iv) if sent by facsimile, the date of
confirmation of receipt if during the recipient’s normal business hours,
otherwise the next Business Day.

 

50.

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If to Roivant, notices must be addressed to:

Roivant Sciences GmbH

Viaduktstrasse 8

4051 Basel, Switzerland

Attention: Head of Global Transactions

with a copy to:

Roivant Sciences, Inc.

320 West 37th Street, 5th Floor

New York, NY 10018

Attention: Legal Department

E-mail: [*]

If to HanAll, notices must be addressed to:

HanAll BioPharma Co., Ltd.

12F Gyeonggi Bio-Center, 147 Kwangkyo-ro

Yeongtong-gu

Suwon, Kyeonggi-do

Seoul

Republic of Korea

Attention: Hyeakyung Ahn

Facsimile: [*]

E-mail: [*]

with a copy to:

HPI Inc.

1 Church St., Suite 103

Rockville, MD 20850

USA

Attention: Minjae Shin

Facsimile: [*]

E-mail: [*]

14.9 Force Majeure. Each Party shall be excused from liability for the failure
or delay in performance of any obligation under this Agreement (other than
failure to make payment when due) by reason of any event beyond such Party’s
reasonable control including Acts of God, fire, flood, explosion, earthquake,
pandemic flu, or other natural forces, war, civil unrest, acts of terrorism,
accident, destruction or other casualty, any lack or failure of transportation
facilities, any lack or failure of supply of raw materials, or any other event
similar to those enumerated

 

51.

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above. Such excuse from liability shall be effective only to the extent and
duration of the event(s) causing the failure or delay in performance and
provided that the Party has not caused such event(s) to occur. Notice of a
Party’s failure or delay in performance due to force majeure must be given to
the other Party within ten (10) days after its occurrence. All delivery dates
under this Agreement that have been affected by force majeure shall be tolled
for the duration of such force majeure. In no event shall any Party be required
to prevent or settle any labor disturbance or dispute.

14.10 Limitation of Liability. EXCEPT FOR LIABILITY FOR BREACH OF ARTICLE 11
(CONFIDENTIALITY), NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER
PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES IN CONNECTION
WITH THIS AGREEMENT OR ANY LICENSES GRANTED HEREUNDER; provided, however, that
this Section 14.10 (Limitation of Liability) shall not be construed to limit
either Party’s indemnification obligations under Article 10 (Indemnification).

14.11 Interpretation. The headings of clauses contained in this Agreement
preceding the text of the sections, subsections and paragraphs hereof are
inserted solely for convenience and ease of reference only and shall not
constitute any part of this Agreement, or have any effect on its interpretation
or construction. All references in this Agreement to the singular shall include
the plural where applicable. Unless otherwise specified, references in this
Agreement to any Article shall include all Sections, subsections and paragraphs
in such Article, references to any Section shall include all subsections and
paragraphs in such Section, and references in this Agreement to any subsection
shall include all paragraphs in such subsection. The word “including” and
similar words means including without limitation. The word “or” means “and/or”
unless the context dictates otherwise because the subject of the conjunction are
mutually exclusive. The words “herein,” “hereof” and “hereunder” and other words
of similar import refer to this Agreement as a whole and not to any particular
Section or other subdivision. All references to days in this Agreement mean
calendar days, unless otherwise specified. Ambiguities and uncertainties in this
Agreement, if any, shall not be interpreted against either Party, irrespective
of which Party may be deemed to have caused the ambiguity or uncertainty to
exist. This Agreement has been prepared in the English language and the English
language shall control its interpretation. In addition, all notices required or
permitted to be given hereunder, and all written, electronic, oral or other
communications between the Parties regarding this Agreement shall be in the
English language.

14.12 Counterparts; Electronic or Facsimile Signatures. This Agreement may be
executed in any number of counterparts, each of which shall be an original, but
all of which together shall constitute one instrument. This Agreement may be
executed and delivered electronically or by facsimile and upon such delivery
such electronic or facsimile signature will be deemed to have the same effect as
if the original signature had been delivered to the other Party.

[SIGNATURE PAGE FOLLOWS]

 

52.

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IN WITNESS WHEREOF, the Parties hereto have caused this LICENSE AGREEMENT to be
executed and entered into by their duly authorized representatives as of the
Effective Date.

 

HANALL BIOPHARMA CO., LTD.    ROIVANT SCIENCES GMBH By:  

/s/ Seung Kook Park

   By:   

/s/ Sascha Bucher

Name: Seung Kook Park    Name: Sascha Bucher Title: Chief Executive Officer   
Title: VP, Head of Global Transactions

SIGNATURE PAGE TO LICENSE AGREEMENT

 

--------------------------------------------------------------------------------

Exhibit A

HL161BKN

Exhibit B

Development Timelines for HL161BKN

Exhibit C

HanAll Patents as of the Effective Date

Exhibit D

Technology Transfer Plan

Exhibit E

Initial High-Level Research Plan

Exhibit F

Assigned Contracts Related to Phase 1 Clinical Trial

 

--------------------------------------------------------------------------------

Exhibit A

[*]

 

A-1

--------------------------------------------------------------------------------

Exhibit B

Development Timelines for HL161BKN

[*]

 

B-1

--------------------------------------------------------------------------------

Exhibit C

HanAll Patents

[*]

 

C-1

--------------------------------------------------------------------------------

Exhibit D

Technology Transfer Plan

[*]

 

D-1

--------------------------------------------------------------------------------

Exhibit E

Initial High-Level Research Plan

[*]

 

E-1

--------------------------------------------------------------------------------

Exhibit F

Assigned Contracts Related to Phase 1 Clinical Trial

The General Services Agreement between HanAll BioPharma Co., Ltd and Quintiles
Pty Ltd. executed on 17th of November, 2017.

 

F-1