Exhibit 10.83

 

 

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

Execution Copy

 

 

 

 

 

 

 

 

Commercialization and License Agreement

 

Between

 

Torii Pharmaceutical Co., Ltd.

 

and

 

BioCryst Pharmaceuticals, Inc.

 

Dated November 5, 2019

 

 

 

 

 

 

 

 

 

 

 

 

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

TABLE OF CONTENTS

 

Page

Article 1 DEFINITIONS  1         Article 2 LICENSES  19         2.1  License
Grants to Torii  19         2.2  Sublicensing and Subcontractors  19        
2.3  License Grants to BioCryst  21         2.4  Reciprocal Sublicensing  21   
     2.5  Retained Rights  22         2.6  Exclusivity Covenant  22         2.7 
Right of First Negotiation  22         Article 3 REGULATORY  25         3.1 
Regulatory Responsibilities  25         3.2  Regulatory Diligence Activities  27
        3.3  Filings and Correspondence  27         3.4  Transfer of Regulatory
Materials  28         3.5  Right of Reference  29         3.6  Adverse Events
Reporting  29         3.7  Regulatory Audits  30         3.8  Notice of Other
Actions  31         Article 4 DEVELOPMENT PROGRAM  31         4.1  Development 
31         Article 5 MANUFACTURING  32         5.1  Supply by BioCryst  32      
  5.2  Product Tracking in the Territory  33         5.3  Shortages  33        
5.4  Accreditation  33         5.5  Audits of Manufacturing Facilities  33      
  5.6  Supply Failure  34         Article 6 COMMERCIALIZATION  35         6.1 
Commercialization Responsibilities.  35         6.2  Commercialization
Diligence  35         6.3  Commercialization Plans  35         6.4  Coordination
of Commercialization Activities  36         6.5  Pricing  36

 

-i-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

        6.6  Diversion  36         6.7  Extraordinary Circumstances.  37        
6.8  Advertising and Promotional Materials.  37         6.9  Product Trademarks 
37         Article 7 GOVERNANCE  39         7.1  Alliance Managers  39        
7.2  Joint Steering Committee  39         7.3  Non-Member Attendance  41        
7.4  Decision-Making  41         7.5  Resolution of JSC Disputes  42        
7.6  No Harmful Actions  44         Article 8 PAYMENTS  44         8.1  Upfront
Payment  44         8.2  Milestone Payments  44         8.3  Transfer Price
Payments to BioCryst  45         8.4  Payments to Third Parties  48         8.5 
Other Amounts Payable  48         8.6  No Refunds  48         8.7  Accounting
Standards  48         8.8  Currency; Exchange Rate  48         8.9  Blocked
Payments  48         8.10  Late Payments  48         8.11  Financial Records and
Audits  48         8.12  Taxes.  49         Article 9 CONFIDENTIALITY;
PUBLICATION  50         9.1  Duty of Confidence  50         9.2  Confidential
Information  51         9.3  Exemptions  51         9.4  Authorized Disclosures 
52         9.5  Tax Treatment  53         9.6  Publications  53         9.7 
Publicity; Use of Names  54         9.8  Attorney-Client Privilege  55        
Article 10 REPRESENTATIONS, WARRANTIES, AND COVENANTS  55         10.1 
Representations and Warranties of Each Party  55         10.2  Representations
and Warranties of BioCryst  56

-ii-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

        10.3  Representations and Warranties of Torii  58         10.4  Covenant
Not to Sue  58         10.5  Covenants of BioCryst  58         10.6  Covenants
of Each Party  59         10.7  NO OTHER WARRANTIES  60         10.8  Compliance
with Laws  60         Article 11 INDEMNIFICATION  60         11.1  By Torii  60
        11.2  By BioCryst  61         11.3  Indemnification Procedure  61      
  11.4  Insurance  62         Article 12 INTELLECTUAL PROPERTY  62         12.1 
Inventions  62         12.2  CREATE Act  63         12.3  Senyo Jisshiken.  63
        12.4  Third Party In-Licenses  63         12.5  Know-How Transfer  65   
     12.6  Patent Prosecution  66         12.7  Patent Enforcement  68        
12.8  Infringement of Third Party Rights  69         12.9  Patent Listings  70
        12.10  Patent Term Extensions  70         12.11  Patent Marking  70   
     Article 13 TERM AND TERMINATION  70         13.1  Term  70         13.2 
Termination  70         13.3  Effect of Expiration  74         13.4  Effect of
Termination.  74         13.5  Survival  78         13.6  Termination Not Sole
Remedy  78         Article 14 DISPUTE RESOLUTION  78         14.1  General  78
        14.2  Negotiation; Escalation  78         14.3  Arbitration  79        
14.4  Injunctive Relief  79         14.5  Confidentiality  79        

-iii-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

14.6  Tolling  79         Article 15 MISCELLANEOUS  79         15.1  Operation
Adjustments for 1st Year  79         15.2  Assignment  79         15.3 
LIMITATION OF LIABILITY  80         15.4  Section 365(n) of the Bankruptcy Code 
80         15.5  Severability  80         15.6  Notices  80         15.7 
Governing Law  81         15.8  Force Majeure  81         15.9  Entire
Agreement; Amendments  81         15.10  Headings  82         15.11  Independent
Contractors  82         15.12  Performance by Affiliates  82         15.13 
Waiver  82         15.14  Waiver of Rule of Construction  82         15.15 
Cumulative Remedies  82         15.16  Business Day Requirements  82        
15.17  Further Actions  82         15.18  Construction  83         15.19 
Language; Translations  83         15.20  Counterparts  83

 

 

 

Schedules

 

Schedule 1.31  BioCryst Patent Rights Schedule 1.47  Compound Schedule 1.103 
BioCryst Knowledge Individuals and Torii Knowledge Individuals Schedule 9.7.1 
Press Release Schedule 10.2.8  List of Encumbrances on BioCryst Technology
Schedule 10.3.6  List of Torii’s Employees

 

 

 

 

-iv-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

Commercialization and License AGREEMENT

 

This Commercialization and License Agreement (this “Agreement”) is made as of
November 5, 2019 (the “Effective Date”) by and between BioCryst Pharmaceuticals,
Inc., a Delaware corporation (“BioCryst”), having a place of business at 4505
Emperor Boulevard, Suite 200, Durham, NC 27703, USA, and Torii Pharmaceutical
Co., Ltd., a corporation organized under the laws of Japan (“Torii”), having a
place of business at 4-1 Nihonbashi-Honcho 3-chome, Chuo-ku, Tokyo, Japan.
BioCryst and Torii are referred to in this Agreement individually as a “Party”
and collectively as the “Parties.”

 

Recitals

 

WHEREAS, BioCryst is a biopharmaceutical company engaged in the Development,
Manufacture, and Commercialization of medicines for treatment of rare diseases,
including a proprietary compound internally designated as BCX7353;

 

WHEREAS, BioCryst Controls certain Know-How and Patent Rights relating to
BCX7353;

 

WHEREAS, BioCryst has conducted the Development of BCX7353 on a global basis and
is in the process of seeking Regulatory Approval for the Licensed Product in the
Field in the Territory;

 

WHEREAS, Torii is a pharmaceutical company engaged in the Development and
Commercialization of pharmaceutical products in the Territory;

 

WHEREAS, BioCryst is seeking a partner to Commercialize the Licensed Product in
the Field in the Territory and Torii desires to acquire rights to Commercialize
the Licensed Product in the Field in the Territory, in each case, upon the terms
and conditions set forth herein; and

 

WHEREAS, BioCryst desires to grant to Torii, and Torii desires to receive from
BioCryst, an exclusive right and license under the BioCryst Technology to
Commercialize the Licensed Product in the Field in the Territory, in each case,
upon the terms and conditions set forth herein.

 

Agreement

 

NOW, THEREFORE, the Parties hereby agree as follows:

 

Article 1
DEFINITIONS

 

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

 

1.1“Accounting Standards” means GAAP or IFRS (as applicable to a Party).

 

1.2“Active Ingredient” means clinically active material that provides
pharmacological activity in a pharmaceutical or biologic product (excluding
formulation components such as coatings, stabilizers, excipients or solvents,
adjuvants, or controlled release technologies).

 

1.3“Additional Development” means the performance of any Additional Essential
Element Expansion Development, Additional Label Expansion Development, or
Additional First Approval Development.

 

 

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

1.4“Additional Development Costs” means all Additional Essential Element
Expansion Costs, Additional Label Expansion Costs, and Additional First Approval
Costs.

 

1.5“Additional Essential Element Expansion Costs” means all internal costs (at
the FTE Rate) and external expenses reasonably incurred by or on behalf of
BioCryst in the performance of any Additional Essential Element Expansion
Development.

 

1.6“Additional Essential Element Expansion Development” means the performance of
any Clinical Trials, other than the Current Phase III Protocols, or other
Development (including non-clinical studies) that are performed after receiving
the first Regulatory Approval for the Licensed Product in HAE-P in the Territory
for the purpose of extending the scope of such first Regulatory Approval to
include all Essential Approval Elements in case that the first Regulatory
Approval fails to cover any Essential Approval Elements.

 

1.7“Additional First Approval Costs” means all internal costs (at the FTE Rate)
and external expenses reasonably incurred by or on behalf of BioCryst in the
performance of any Additional First Approval Development.

 

1.8“Additional First Approval Development” means the performance of any Clinical
Trials, other than the Current Phase III Protocols, or other Development
(including non-clinical studies) that are required by the PMDA or the MHLW to
receive the first Regulatory Approval for the Licensed Product in HAE-P in the
Territory.

 

1.9“Additional Label Expansion Costs” means all internal costs (at the FTE Rate)
and external expenses reasonably incurred by or on behalf of BioCryst in the
performance of any Additional Label Expansion Development.

 

1.10“Additional Label Expansion Development” means the performance of any
Clinical Trials, other than the Current Phase III Protocols, or other
Development (including non-clinical studies) that are performed after receiving
the first Regulatory Approval for the Licensed Product in HAE-P in the Territory
for the purpose of extending the scope of such first Regulatory Approval to the
extent within the scope proposed in the first MAA filed with the applicable
Regulatory Authorities for the Licensed Product in the Field in the Territory,
but expressly excluding any Development in furtherance of extending the first
Regulatory Approval to include any Essential Approval Elements.

 

1.11“Adjusted NHI Price” means the price for the Licensed Product in the Field
in the Territory, per patient per day calculated on the basis of: (a) the
standard daily dosage per patient; and (b) the most commonly used dosage unit
(and dosage form), the price of which (for the dosage unit) is established by
the National Health Insurance system in the Territory, exclusive of any
consumption tax.

 

1.12“Affiliates” of a Person means any other Person that (directly or
indirectly) is controlled by, controls, or is under common control with such
Person. For the purposes of this definition, the term “control” (including, with
correlative meanings, the terms “controlled by” and “under common control with”)
as used with respect to a Person, will mean the possession, directly or
indirectly, of the power to direct, or cause the direction of, the management or
policies of such Person, whether through the ownership of voting securities, by
contract or otherwise, and “control” will be presumed to exist if either of the
following conditions is met: (a) in the case of a corporate entity, direct or
indirect ownership of voting securities entitled to cast at least 50% of the
votes in the election of directors or (b) in the case of a non-corporate entity,
direct or indirect ownership of at least fifty percent (50%) of the equity
interests with the power to direct the management and policies of such entity.
For all purposes of this Agreement, BioCryst or its Affiliates will not be an
Affiliate of Torii or any of Torii’s Affiliates, and Torii or its Affiliates
will not be an Affiliate of BioCryst or any of BioCryst’s Affiliates.

 

-2-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

1.13“Agreement” has the meaning set forth in the Preamble.

 

1.14“Alliance Manager” has the meaning set forth in Section 7.1 (Alliance
Managers).

 

1.15“Alternative Products License Exercise Notice” has the meaning set forth in
Section 2.7.2 (Alternative Products ROFN).

 

1.16“Alternative Products License Negotiation Period” has the meaning set forth
in Section 2.7.2 (Alternative Products ROFN).

 

1.17“Anti-Corruption Laws” means any local and other anti-corruption laws,
including the provisions of the United States Foreign Corrupt Practices Act, as
amended.

 

1.18“Applicable Law” means collectively all laws, statutes, rules, regulations,
ordinances, decrees, judicial and administrative orders, judgments, notices, and
guidelines (and any license, franchise, permit, or similar right granted under
any of the foregoing), and any policies and other requirements of any applicable
Governmental Authority that govern or otherwise apply to a Party or the
activities contemplated herein, including all Anti-Corruption Laws.

 

1.19“Approved Labeling” means, with respect to a Licensed Product: (a) the
Regulatory Authority-approved full prescribing information for such Licensed
Product; and (b) the Regulatory Authority-approved labels and other written,
printed, or graphic materials on any container, wrapper, or any package insert
that is used with or for such Licensed Product.

 

1.20“Arbitration Draft” has the meaning set forth in Section 2.7.4(a)
(Arbitration Drafts).

 

1.21“Assigned Regulatory Materials” has the meaning set forth in Section 3.4.1
(Regulatory Transfer).

 

1.22“BioCryst” has the meaning set forth in the Preamble.

 

1.23“BioCryst Identified Rights” has the meaning set forth in Section 12.4.1
(BioCryst Identified Rights).

 

1.24“BioCryst Inability to Supply” means Torii’s reasonable belief that BioCryst
will be unable to deliver to Torii or its designee sufficient supply of Licensed
Product to meet market demand for the Licensed Product in the Field in the
Territory (i.e., such that some patients in the Field in the Territory are
unable to obtain the Licensed Product) despite (a) Torii’s delivery of timely
conforming purchase orders to BioCryst in accordance with the Supply Agreement
in sufficient quantities to meet such demand, (b) Torii’s maintenance of
commercially reasonable levels of safety stock of the Licensed Product, and (c)
the CMOs’ having sufficient manufacturing capacity to meet the worldwide market
demand for Licensed Products and making timely deliveries of Licensed Product
properly ordered by BioCryst in accordance with its agreements with its CMOs.

 

1.25“BioCryst Indemnitee(s)” has the meaning set forth in Section 11.1
(Indemnification; By Torii).

 

1.26“BioCryst In-Licensed Rights” has the meaning set forth in Section 12.4.3
(Third Party IP Agreements).

 

-3-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

1.27“BioCryst Know-How” means all Know-How (excluding BioCryst’s interest in
Joint Know-How) that is (a) Controlled by BioCryst or any of its Affiliates as
of the Effective Date or during the Term, and (b) necessary or reasonably useful
to perform the Torii Activities with respect to the Licensed Product in the
Field in the Territory.

 

1.28“BioCryst Manufacturing Know-How” means all Know-How that is (a) Controlled
by BioCryst or any of its Affiliates as of the Effective Date or during the
Term, and (b) necessary or reasonably useful to Manufacture the Licensed Product
for Commercialization purposes in the Field in the Territory.

 

1.29“BioCryst Manufacturing Patent Rights” means all Patent Rights that are (a)
Controlled by BioCryst or any of its Affiliates as of the Effective Date or
during the Term, and (b) necessary or reasonably useful (or, with respect to
patent applications, would be necessary or reasonably useful if such patent
applications were to issue as patents) to Manufacture the Licensed Product for
Commercialization purposes in the Field in the Territory.

 

1.30“BioCryst Manufacturing Technology” means the BioCryst Manufacturing
Know-How and BioCryst Manufacturing Patent Rights.

 

1.31“BioCryst Patent Rights” means all Patent Rights (excluding BioCryst’s
interest in Joint Patent Rights) that are (a) Controlled by BioCryst or any of
its Affiliates as of the Effective Date or during the Term, and (b) necessary or
reasonably useful (or, with respect to patent applications, would be necessary
or reasonably useful if such patent applications were to issue as patents) to
perform the Torii Activities with respect to the Licensed Product in the Field
in the Territory. Schedule 1.31 (BioCryst Patent Rights) sets forth the BioCryst
Patent Rights that are owned or exclusively licensed by BioCryst in the
Territory and that exist as of the Effective Date.

 

1.32“BioCryst Technology” means BioCryst Know-How, BioCryst Patent Rights, and
BioCryst’s interest in the Joint Technology.

 

1.33“Business Day” means a day other than a Saturday, Sunday, or a day on which
banking institutions in Durham, North Carolina (USA) or Tokyo, Japan are
authorized or required by Applicable Law to remain closed.

 

1.34“Buyers” has the meaning set forth in Section 1.113 (Net Sales).

 

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

 

1.36“Calendar Year” means each 12-month period commencing on January 1.

 

1.37“cGMP” means all applicable then-current laws and guidelines applicable to
the Manufacture of the Licensed Product, including, as applicable, (a) the
principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R.
Parts 4, 210, 211, 601, 610 and 820, (b) European Directive 2003/94/EC and
Eudralex 4, (c) the principles detailed in the International Conference on
Harmonization’s Q7 guidelines, (d) those standards required by the MHLW, and (e)
the equivalent Applicable Law in any relevant country or region, each as may be
amended and applicable from time to time.

 

1.38“Change of Control” means, with respect to a Party, that: (a) any Third
Party acquires directly or indirectly the beneficial ownership of any voting
security of such Party, or if the percentage ownership of such Third Party in
the voting securities of such Party is increased through stock redemption,
cancellation, or other recapitalization, and immediately after such acquisition
or increase such Third Party is, directly or indirectly, the beneficial owner of
voting securities representing at least fifty percent (50%) of the total voting
power of all of the then outstanding voting securities of such Party; (b) a
merger, consolidation, recapitalization, or reorganization of such Party is
consummated that would result in shareholders or equity holders of such Party
immediately prior to such transaction, owning at least fifty percent (50%) of
the outstanding voting securities of the surviving entity (or its parent entity)
immediately following such transaction; or (c) there is a sale or transfer to a
Third Party of all or substantially all of such Party’s consolidated assets
taken as a whole, through one or more related transactions.

 

-4-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

1.39“Clinical Trial” means any clinical trial in humans that is conducted in
accordance with GCP and is designed to generate data in support or maintenance
of a CTA or MAA, or other similar marketing application, whether prior to or
after receipt of Regulatory Approval for a pharmaceutical or biologic product.

 

1.40“CMO” means a contract manufacturing organization.

 

1.41“Commercialization” means any and all activities directed to the marketing,
promotion, distribution, pricing, importing, reimbursement, offering for sale,
and sale of a pharmaceutical product and interacting with Regulatory Authorities
following receipt of Regulatory Approval in the applicable country or region for
such pharmaceutical product regarding the foregoing, including seeking any
required Reimbursement Approval (except for activities related to Reimbursement
Approval in the Field in the Territory before the Regulatory Responsibility
Transfer Date) and all post-marketing surveillance, but excluding activities
directed to Manufacturing, Development, or Post-Marketing Activities.
“Commercialize,” “Commercializing,” and “Commercialized” will be construed
accordingly.

 

1.42“Commercialization Plan” has the meaning set forth in Section 6.3
(Commercialization Plans).

 

1.43“Commercially Reasonable Efforts” means, [***].

 

1.44“Competitive Product” means (a) during the period commencing on the
Effective Date and continuing until the end of the [***] Launch Year of the
first Licensed Product in the Field in the Territory, any pharmaceutical or
biologic product for HAE-A or HAE-P in the Territory, other than a Complementary
Product, and (b) following the [***] Launch Year of the first Licensed Product
in the Field in the Territory, any pharmaceutical product containing a selective
kallikrein inhibitor in the Field in the Territory.

 

1.45“Competitive Product Launch Year” has the meaning set forth in Section 7.5.2
(Final Decision-Making Authority).

 

1.46“Complementary Product” means a pharmaceutical or biologic product for HAE-A
or HAE-P that (a) does not contain a selective kallikrein inhibitor and (b)
would not be reasonably expected to be prescribed in lieu of the Licensed
Product in the Field in the Territory or otherwise decrease the Net Sales or
market share of the Licensed Product in the Field in the Territory.

 

1.47“Compound” means BioCryst’s proprietary compound designated as BCX7353,
[***].

 

1.48“Confidential Information” means, subject to Section 9.3 (Exemptions), (a)
Know-How and any technical, scientific, trade, research, manufacturing,
business, financial, marketing, product, supplier, intellectual property, and
other non-public or proprietary data or information (including unpublished
patent applications) that may be disclosed by one Party or its Controlled
Affiliates or JT (with respect to Torii) or Affiliates (with respect to
BioCryst) to the other Party or its Controlled Affiliates or JT (with respect to
Torii) or Affiliates (with respect to BioCryst) pursuant to this Agreement
(including information disclosed prior to the Effective Date pursuant to the
Nondisclosure Agreement), regardless of whether such information is specifically
marked or designated as confidential and regardless of whether such information
is in written, oral, electronic, or other form, and (b) the terms of this
Agreement.

 

-5-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

1.49“Control” or “Controlled” means (a) the possession by a Party (whether by
ownership, license, or otherwise other than pursuant to this Agreement) of, (i)
with respect to any tangible Know-How, the legal authority or right to physical
possession of such tangible Know-How, with the right to provide such tangible
Know-How to the other Party on the terms set forth herein, or (ii) with respect
to Patent Rights, Regulatory Approvals, Regulatory Submissions, intangible
Know-How, or other intellectual property rights, the legal authority or right to
grant a license, sublicense, access, right of reference, or right to use (as
applicable) to the other Party under such Patent Rights, Regulatory Approvals,
Regulatory Submissions, intangible Know-How, or other intellectual property
rights on the terms set forth herein, in each case ((i) and (ii)), without
breaching or otherwise violating the terms of any arrangement or agreement with
a Third Party in existence as of the time such Party or its Controlled
Affiliates (with respect to Torii) or Affiliates (with respect to BioCryst)
would first be required hereunder to grant the other Party such access, right of
reference, right to use, licenses, or sublicense and without being required to
make any payment to any Third Party other than payment obligations related to
BioCryst In-Licensed Rights in accordance with Section 12.4.3 (Third Party IP
Agreements) and (b) with respect to any product, the possession by a Party of
the ability (whether by sole or joint ownership, license, or otherwise, other
than pursuant to the licenses granted under this Agreement) to grant an
exclusive license or sublicense of Patent Rights that Cover such product or
proprietary Know-How that is used in connection with the Exploitation of such
product. Notwithstanding the foregoing, a Party and its Affiliates will not be
deemed to “Control” any Patent Right, Know-How, or product that, prior to the
consummation of a Change of Control of such Party, is owned or in-licensed by a
Third Party that becomes an Affiliate of such acquired Party after the Effective
Date as a result of such Change of Control unless (A) prior to the consummation
of such Change of Control, such acquired Party or any of its Affiliates also
Controlled such Patent Right, Know-How, or product, or (B) the Know-How, Patent
Rights, or product owned or in-licensed by the applicable Third Party were not
used in the performance of activities under this Agreement prior to the
consummation of such Change of Control, but after the consummation of such
Change of Control, such acquired Party or any of its Affiliates determines to
use or uses any such Patent Rights, Know-How, or product in the performance of
its obligations or exercise of its rights under this Agreement, in each of which
cases ((A) and (B)), such Patent Rights, Know-How, or product will be
“Controlled” by such Party for purposes of this Agreement.

 

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

 

-6-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

1.51“Controlling Party” has the meaning set forth in Section 12.7.1 (Notice).

 

1.52“Cover” means, with respect to a particular subject matter at issue and a
relevant Patent Right, that the manufacture, use, sale, offer for sale, or
importation of such subject matter would fall within the scope of one or more
claims in such Patent Right.

 

1.53“CPI” means with respect to BioCryst, the Consumer Price Index-Urban Wage
Earners and Clerical Workers, U.S. City Average, All Items 1982-84=100,
published by the United States Department of Labor, Bureau of Labor Statistics
(or its successor equivalent index), in the United States, and with respect to
Torii, the Consumer Price Index published by the Statistics Bureau, Ministry of
Internal Affairs and Communications of Japan.

 

1.54“CREATE Act” has the meaning set forth in Section 12.2 (CREATE Act).

 

1.55“CTA” means: (a) with respect to Japan, a common technical document filed
with the MHLW as required by Applicable Law to conduct a Clinical Trial in
Japan; (b) with respect to the U.S., an Investigational New Drug application
required pursuant to 21 C.F.R. Part 312; (c) any foreign equivalents as filed
with the applicable Regulatory Authorities in other countries or regulatory
jurisdictions, as applicable; and (d) all supplements and amendments that may be
filed with respect to the foregoing.

 

1.56“Current Phase III Protocols” means the protocol as of the Effective Date or
as may be amended by BioCryst during the Term for the Phase III Clinical Trials
for which BioCryst is the sponsor for the Licensed Product in the Field
registered at www.clinicaltrials.gov as (a) “Efficacy and Safety Study of
BCX7353 as an Oral Treatment for the Prevention of Attacks in HAE (APeX-2)” and
(b) “Study to Evaluate the Efficacy and Safety of BCX7353 as an Oral Treatment
for the Prevention of HAE Attacks in Japan (APeX-J).”

 

1.57“Debarred/Excluded” means any Person becoming debarred or suspended under 21
U.S.C. §335(a) or (b), the subject of a conviction described in Section 306 of
the FD&C Act, excluded, or having previously been excluded, from a federal or
governmental health care program, debarred from federal contracting, convicted
of or pled nolo contendere to any felony, or to any federal or state legal
violation (including misdemeanors) relating to prescription drug products or
fraud, the subject to OFAC sanctions or on the OFAC list of specially designated
nationals, or the subject of any similar sanction of any Governmental Authority
in the Territory.

 

1.58“Default” has the meaning set forth in Section 13.2.2 (Termination for
Cause).

 

1.59“Default Notification” has the meaning set forth in Section 13.2.2
(Termination for Cause).

 

1.60“Development” means all internal and external research, development, and
regulatory activities related to pharmaceutical or biologic products, including
(a) non-clinical testing, toxicology, testing and studies, non-clinical and
preclinical activities, and Clinical Trials, and (b) preparation, submission,
review, and development of data or information for the purpose of submission to
a Regulatory Authority to obtain authorization to conduct Clinical Trials or to
obtain, support, or maintain Regulatory Approval of a pharmaceutical or biologic
product, but excluding activities directed to Manufacturing, Post-Marketing
Activities, or Commercialization. Development will include development and
regulatory activities for additional forms, formulations, or indications for a
pharmaceutical or biologic product after receipt of Regulatory Approval of such
product (including label expansion) other than Post-Marketing Activities,
including Clinical Trials initiated following the receipt of Regulatory Approval
or any Clinical Trial to be conducted after receipt of Regulatory Approval that
was mandated by the applicable Regulatory Authority as a condition of receipt of
such Regulatory Approval with respect to an approved formulation or indication.
“Develop,” “Developing,” and “Developed” will be construed accordingly.

 

-7-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

1.61“Disclosing Party” has the meaning set forth in Section 9.1.1 (Duty of
Confidence).

 

1.62“Dispute” has the meaning set forth in Section 14.1 (Dispute Resolution;
General).

 

1.63“Dollar” means the U.S. dollar, and “$” will be interpreted accordingly.

 

1.64“Effective Date” has the meaning set forth in the Preamble.

 

1.65“Essential Approval Elements” means the following elements to be included in
the scope of the Regulatory Approval for the Licensed Product in HAE-P in the
Territory: [***].

 

1.66“Examined Party” has the meaning set forth in Section 8.11 (Financial
Records and Audits).

 

1.67“Executive Officers” has the meaning set forth in Section 7.4.2 (Decisions
of the JSC).

 

1.68“Exploit” means to make, have made, use, offer to sell, sell, Develop,
Manufacture, Commercialize, or otherwise exploit. “Exploitation” will be
construed accordingly.

 

1.69“FD&C Act” means the United States Federal Food, Drug and Cosmetic Act, as
amended from time to time, together with any rules, regulations, and
requirements promulgated thereunder (including all additions, supplements,
extensions, and modifications thereto).

 

1.70“FDA” means the United States Food and Drug Administration or any successor
entity thereto having essentially the same function.

 

1.71“Field” means HAE-P, and, solely if agreed in writing by each Party in
accordance with Section 2.7.1 (Field Expansion ROFN), HAE-A.

 

1.72“Field Expansion Exercise Notice” has the meaning set forth in Section 2.7.1
(Field Expansion ROFN).

 

1.73“Field Expansion Negotiation Period” has the meaning set forth in
Section 2.7.1 (Field Expansion ROFN).

 

1.74“Field Expansion Notice” has the meaning set forth in Section 2.7.1 (Field
Expansion ROFN).

 

1.75“First Commercial Sale” means, with respect to a Licensed Product or Generic
Product (as applicable) in any country, the first sale of such Licensed Product
or Generic Product (as applicable) to a Third Party for distribution, use, or
consumption in such country after receipt of Regulatory Approvals for such
Licensed Product in such country. First Commercial Sale excludes any sale or
other distribution of a Licensed Product for use in a Clinical Trial or other
Development activity.

 

1.76“First Failed Year” has the meaning set forth in Section 13.2.3 (Failure to
Achieve Performance Targets).

 

1.77“FTE” means [***].

 

-8-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

1.78“FTE Rate” means the amount for an FTE per Calendar Year, which will be
discussed in good faith and determined by the JSC prior to commencing any
relevant activities hereunder that require reimbursement at the FTE Rate, after
which agreement by the JSC the FTE Rate will be subject to an annual adjustment
by the percentage increase or decrease in the applicable CPI.

 

1.79“GAAP” means the generally accepted accounting principles in the United
States or Japan, consistently applied.

 

1.80“GCP” means all applicable good clinical practice standards for the design,
conduct, performance, monitoring, auditing, recording, analyses and reporting of
Clinical Trials, including, as applicable (a) as set forth in the International
Conference on Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical
Practice (CPMP/ICH/135/95) (the “ICH Guidelines”) and any other guidelines for
good clinical practice for trials on medicinal products in the Territory, (b)
the Declaration of Helsinki (2013) as last amended at the 52nd World Medical
Association in October 2000 and any further amendments or clarifications
thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of
Human Subjects), 56 (Institutional Review Boards), and 312 (Investigational New
Drug Application), as may be amended from time to time, and (d) the equivalent
Applicable Law in the Territory, each as may be amended and applicable from time
to time and in each case, that provide for, among other things, assurance that
the clinical data and reported results are credible and accurate and protect the
rights, integrity, and confidentiality of trial subjects.

 

1.81“Generic Launch Quarter” means, with respect to a Generic Product in the
Territory, the Calendar Quarter in which the First Commercial Sale of the
applicable Generic Product occurs in the Territory.

 

1.82“Generic Product” means, with respect to a particular Licensed Product in
the Territory, a product that (a) contains the same Active Ingredient as the
applicable Licensed Product in the same route of administration (e.g., oral,
injectable, or intranasal) as the applicable Licensed Product, (b) relies on or
receives Regulatory Approval through the use of data included in the Regulatory
Submissions for such Licensed Product and is categorized by the applicable
Regulatory Authority in such country to be therapeutically equivalent to, or
interchangeable with, such Licensed Product, such that the pharmaceutical
product may be substituted for such Licensed Product at the point of dispensing,
(c) has received all necessary Regulatory Approvals and Reimbursement Approvals
from such Regulatory Authorities in the Territory to market and sell such
product as a pharmaceutical product for any of the Indications included in the
Approved Labeling for such Licensed Product, and (d) is sold or marketed for
sale in the Territory by a Third Party that has not obtained the rights to
market or sell such product as a Sublicensee, Subcontractor, or Third Party
Distributor of Torii or any of its Affiliates, Sublicensees, or Subcontractors
with respect to such Licensed Product.

 

1.83“Global Brand Elements” has the meaning set forth in Section 6.9.1 (Global
Brand Elements).

 

1.84“Global Brand Strategy” has the meaning set forth in Section 6.3.3 (After
the Sixth Launch Year).

 

1.85“GLP” means all applicable good laboratory practice standards, including, as
applicable, as set forth in the then-current good laboratory practice standards
promulgated or endorsed by the U.S. Food and Drug Administration, as defined in
21 C.F.R. Part 58, and the equivalent Applicable Law in the region in the
Territory, each as may be amended and applicable from time to time.

 

-9-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

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

 

1.87“HAE” means hereditary angioedema.

 

1.88“HAE-A” means the treatment of acute HAE attacks.

 

1.89“HAE-P” means the prevention or prophylaxis of HAE attacks.

 

1.90“ICC Rules” has the meaning set forth in Section 14.3 (Arbitration).

 

1.91“IFRS” means International Financial Reporting Standards, consistently
applied.

 

1.92“Indemnified Party” has the meaning set forth in Section 11.3
(Indemnification Procedure).

 

1.93“Indemnifying Party” has the meaning set forth in Section 11.3
(Indemnification Procedure).

 

1.94“Indication” means a separate and distinct disease, disorder, or medical
condition that a Licensed Product is intended to treat, prevent, cure, or
ameliorate in the indication section of the Approved Labeling for such Licensed
Product, or that is the subject of a Clinical Trial and where it is intended
that the data and results of such Clinical Trial (if successful) will be used to
support a Regulatory Submission and Regulatory Approval that is intended to
result in distinct labeling in the indication section of the Approved Labeling
relevant to usage of such Licensed Product in such disease, disorder, or medical
condition that is separate and distinct from another disease, disorder, or
medical condition; provided that for purposes of this Agreement HAE-P and HAE-A
are two separate Indications.

 

1.95“Invention” means any new and useful process, manufacture, or composition of
matter, know-how, or other invention that is conceived and first reduced to
practice, constructively or actually, by either Party or jointly by the Parties
in connection with the performance of activities under this Agreement.

 

1.96“Investigator Initiated Clinical Development” means a clinical trial in
humans that is conducted in accordance with GCP for a Licensed Product inside
the Field in the Territory that is sponsored and conducted by a physician,
physician group, or other Third Party not acting on behalf of a Party or its
Affiliate and who does not have a license from a Party or its Affiliate to
Commercialize such Licensed Product, and with respect to which a Party or its
Affiliate provides supplies of the Licensed Product, funding, or other support
for such clinical trial.

 

1.97“Joint Know-How” means any Know-How, developed or invented during the Term
in the performance of activities under this Agreement jointly by a Party or such
Party’s or its Controlled Affiliates’ (with respect to Torii) or Affiliates’
(with respect to BioCryst), licensees’, Sublicensees’, or Subcontractors’
employees, agents, or independent contractors, or any Persons contractually
required to assign or license such Know-How to such Party or any Controlled
Affiliates of Torii, or Affiliate of BioCryst (as applicable), on the one hand,
and the other Party or such Party’s or its Controlled Affiliates’ (with respect
to Torii) or Affiliates’ (with respect to BioCryst), licensees’, Sublicensees’,
or Subcontractors’ employees, agents, or independent contractors, or any Persons
contractually required to assign or license such Know-How to such Party or any
Controlled Affiliate of Torii, or Affiliate of BioCryst (as applicable), on the
other hand.

 

-10-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

1.98“Joint Patent Rights” means any Patent Right that (a) has a priority date
after the Effective Date and (b) Covers any Invention included in the Joint
Know-How.

 

1.99“Joint Technology” means the Joint Know-How and the Joint Patent Rights.

 

1.100“JSC” has the meaning set forth in Section 7.2.1 (Formation and Purpose of
JSC).

 

1.101“JT” means Japan Tobacco Inc.

 

1.102“Know-How” means any proprietary information and materials, including
records, discoveries, improvements, modifications, processes, techniques,
methods, assays, chemical or biological materials, designs, protocols, formulas,
data (including physical data, chemical data, toxicology data, animal data, raw
data, clinical data, and analytical and quality control data), dosage regimens,
control assays, product specifications, marketing, pricing and distribution
costs, Inventions, algorithms, technology, forecasts, profiles, strategies,
plans, results in any form whatsoever, know-how and trade secrets (in each case,
patentable, copyrightable or otherwise).

 

1.103“Knowledge” means with respect to BioCryst, the actual knowledge of the
BioCryst individuals in the roles set forth on Schedule 1.103, and with respect
to Torii, the actual knowledge of the Torii individuals in the roles set forth
on Schedule 1.103, in each case, as of the Effective Date.

 

1.104“Launch Year” means each full period of twelve (12) successive month
commencing on the first day of the next calendar month after the date of the
First Commercial Sale of the Licensed Product in the Field in the Territory.

 

1.105“Licensed Product” means any pharmaceutical or biologic product containing
the Compound (whether alone as the sole Active Ingredient or as a combination
with one or more other Active Ingredients), (a) in the strengths, presentations,
formulations, and modes of administration in existence as of the Effective Date,
and (b) in any other strength, presentation, formulations, and modes of
administration developed by or on behalf of BioCryst during the Term.

 

1.106“Loss of Market Exclusivity” means a condition where, with respect to a
particular Licensed Product in the Territory in the Field: (a) one or more
Generic Products are being marketed or sold by a Third Party; and (b) [***].

 

1.107“Losses” means damages, debts, obligations, and other liabilities, losses,
claims, taxes, interest obligations, deficiencies, judgments, assessments,
fines, fees, penalties, or expenses (including amounts paid in settlement,
interest, court costs, costs of investigators, reasonable fees and expenses of
attorneys, accountants, financial advisors, consultants, and other experts, and
other expenses of litigation).

 

1.108“Manufacture” means activities directed to manufacturing, processing,
packaging, labeling, filling, finishing, assembly, shipping, storage, or freight
of any pharmaceutical or biologic product (or any components or process steps
involving any product or any companion diagnostic), placebo, or comparator
agent, as the case may be, including quality assurance and stability testing,
characterization testing, quality control release testing of drug substance and
drug product, quality assurance batch record review and release of product,
process development, qualification, and validation, scale-up, pre-clinical,
clinical, and commercial manufacture and analytic development, and product
characterization, but excluding activities directed to Development, or
Commercialization. “Manufacturing” and “Manufactured” will be construed
accordingly.

 

-11-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

1.109“Marketing Authorization Application” or “MAA” means any new drug
application, biologics license application, or other marketing authorization
application (including a partial change approval application), in each case,
filed with the applicable Regulatory Authority in a country or other regulatory
jurisdiction, which application is required to commercially market or sell a
pharmaceutical or biologic product in such country or jurisdiction (and any
amendments thereto), including any new drug application filed with the PMDA and
approved by the MHLW.

 

1.110“MHLW” means the Ministry of Health, Labour, and Welfare, otherwise
referred to as “Koseirodo-Sho,” or any successor entity thereto having
essentially the same function.

 

1.111“Milestone Events” has the meaning set forth in Section 8.2.1 (Milestone
Events and Payments).

 

1.112“Milestone Payment” has the meaning set forth in Section 8.2.1 (Milestone
Events and Payments).

 

1.113“Net Sales” means with respect to a Licensed Product, the gross amount
invoiced or received by or for the benefit of Torii and its Affiliates and
Sublicensees (each of the foregoing, a “Seller”) to a Third Party (including
Third Party Distributors) (“Buyers”) in bona fide arm’s length transactions with
respect to such Licensed Product, less the following deductions, in each case,
to the extent actually allowed and taken by such Buyers and not otherwise
recovered by or reimbursed to Seller in connection with such Licensed Product:

 

(a)transportation and insurance costs incurred in transporting such Licensed
Product to customers, to the extent actually incurred and itemized;

 

(b)sales, excise taxes, tariffs, and duties paid by the Seller and any other
governmental charges or taxes imposed specifically upon the sale,
transportation, delivery, use, exportation, or importation of such Licensed
Product and actually paid;

 

(c)usual and customary discounts actually allowed and taken (including trade,
cash, and quantity discounts) in connection with the sale of such Licensed
Product that are not otherwise attributable to other products of Torii or its
Affiliates;

 

(d)sales returns, allowances or credits to such Buyer actually given or amounts
actually repaid by Seller and not in excess of the selling price of such
Licensed Product on account of rejection, outdating, recalls, price adjustments,
or billing errors of such Licensed Product;

 

(e)amounts written off by reason of uncollectible debt if and when actually
written off or allowed in accordance with Seller’s accounting policies, as
consistently applied, after commercially reasonable debt collection efforts have
been exhausted not to exceed [***] of Net Sales in the aggregate in any period;
provided that such amounts will be added back to Net Sales if and when
collected;

 

(f)discounts actually paid under government-legislated or Seller-sponsored
discount prescription drug programs or other similar coupon or voucher programs;
and

 

(g)rebates, reimbursements, fees, clawbacks, discounts, charge-backs, or similar
payments paid or credited to Third Party Distributors, pharmacies and other
retailers, buying groups (including group purchasing organizations), health care
insurance carriers, Third Party payor, administrator, or contractee, pharmacy
benefit management companies, health maintenance organizations, Governmental
Authorities, hospitals, or other institutions or health care organizations, to
the extent such payments are not attributable to other products of Torii or its
Affiliates or Sublicensees or other services of Torii or its Affiliates or
Sublicensees that are unrelated to the sales and distribution of the Licensed
Product.

 

-12-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

If Seller receives non-cash consideration for a Licensed Product sold to a Buyer
during the Term, then the Net Sales amount for such Licensed Product will be
calculated based on the average arms-length cash selling price for such Licensed
Product over the immediately prior four Calendar Quarters in the relevant
countries or regions.

 

No deduction will be made for any item of cost incurred by any Seller in
Developing or Commercializing Licensed Product except as permitted pursuant to
clauses (a) to (g) of the foregoing sentence; provided that Licensed Product
transferred to Buyers in reasonable quantities in connection with Clinical
Trials, establishing assays for acceptance test, expanded access programs,
compassionate sales or use programs (including named patient programs or single
patient programs), indigent programs, or promotional use in reasonable
quantities (including samples), in each case, will give rise to Net Sales only
to the extent that Seller invoices or receives amounts therefor. If a single
item falls into more than one of the categories set forth in clauses (a)-(g)
above, then such item may not be deducted more than once.

 

All deductions in clauses (a) through (g) above will be fairly and equitably
allocated between such Licensed Product and other products of Torii and its
Affiliates and Sublicensees such that such Licensed Product does not bear a
disproportionate portion of such deductions. Calculations of Net Sales will be
consistently applied across all products of Seller and will be consistent
between periods.

 

Such amounts will be determined from the books and records of the applicable
Seller, and will be calculated in accordance with applicable Accounting
Standards.

 

Transfers or sales between Torii and its Affiliates and Sublicensees will be
disregarded for purposes of calculating Net Sales, except if such purchaser is
an end user.

 

If the Parties agree to Develop and Commercialize a Licensed Product that
includes any Know-How or Patent Rights Controlled by Torii or any of its
Affiliates, then, prior to commencing any such Development or Commercialization
of such Licensed Product, the Parties will discuss in good faith the financial
and other terms upon which such Licensed Product would be Developed,
Manufactured, and Commercialized, including appropriate cross licenses and an
appropriate allocation of Net Sales.

 

1.114“Nondisclosure Agreement” means that certain Nondisclosure Agreement dated
[***] by and between BioCryst and JT.

 

1.115“OFAC” means the Office of Foreign Assets Control of the United States
Department of the Treasury or any successor agency thereto.

 

1.116“Open Accounts” has the meaning set forth in Section 6.3.1 (First and
Second Launch Years).

 

1.117“Party” or “Parties” has the meaning set forth in the Preamble.

 

-13-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

1.118“Patent Challenge” has the meaning set forth in Section 13.2.4 (Termination
for Patent Challenge).

 

1.119“Patent Prosecution” means activities directed to (a) preparing, filing,
and prosecuting applications (of all types) for any Patent Right, (b)
maintaining any Patent Right, and (c) deciding whether to abandon or maintain
any Patent Right.

 

1.120“Patent Rights” means (a) all patents and patent applications in any
country or region, (b) all patent applications filed either from such patents or
patent applications or from an application claiming priority from any of these,
including divisionals, continuations, continuations-in-part, provisionals,
converted provisionals, and continued prosecution applications, (c) any and all
patents that have issued or in the future issue from the foregoing patent
applications, and (d) any and all substitutions, renewals, registrations,
confirmations, extensions, or restorations, including revalidations, reissues,
and re-examinations (including any supplementary protection certificates and the
like) of the foregoing patents or patent applications.

 

1.121“Paying Party” has the meaning set forth in Section 8.12.2 (Tax
Cooperation).

 

1.122“Performance Target Payment” has the meaning set forth in Section 13.2.3
(Failure to Achieve Performance Targets).

 

1.123“Performance Target Period” has the meaning set forth in Section 13.2.3
(Failure to Achieve Performance Targets).

 

1.124“Performance Targets” has the meaning set forth in Section 6.3.2 (Third
Through Sixth Launch Years).

 

1.125“Permitted Torii CMOs” has the meaning set forth in Section 2.2.2 (Right to
Subcontract).

 

1.126“Person” means any corporation, limited or general partnership, limited
liability company, joint venture, joint stock company, trust, unincorporated
association, governmental body, authority, bureau, or agency, or any other
entity or body, or an individual.

 

1.127“Phase III Clinical Trial” means a clinical trial in humans of a
pharmaceutical or biologic product performed to gain evidence with statistical
significance of the efficacy of such product in a target population, and to
obtain expanded evidence of safety for such product that is needed to evaluate
the overall benefit-risk relationship of such product, to form the basis for
approval of an MAA by a Regulatory Authority and to provide an adequate basis
for physician labeling, in a manner that is generally consistent with 21 C.F.R.
§ 312.21(c), as amended (or its successor regulation), or, with respect to any
other country or region, the equivalent of such a clinical trial in such other
country or region.

 

1.128“PMDA” means the Pharmaceuticals and Medical Devices Agency in Japan or any
successor thereto that conducts scientific reviews of marketing authorization
applications for pharmaceuticals and monitoring of their post-marketing safety
in Japan.

 

1.129“Post-Marketing Activities” means post marketing surveillance,
post-marketing studies, observational studies, implementation and management of
registries and analysis thereof, in each case, if required by any Regulatory
Authority in the Territory to support or maintain Regulatory Approval for a
pharmaceutical or biologic product in the Field in the Territory.

 

1.130“Post-Marketing Budget” has the meaning set forth in Section 3.1.2
(Post-Marketing Activities).

 

-14-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

1.131“Product Infringement” has the meaning set forth in Section 12.7.1 (Patent
Enforcement; Notice).

 

1.132“Product Marks” has the meaning set forth in Section 6.9.2 (Product Marks
in the Field in the Territory).

 

1.133“Promotional Materials” means all written, printed, graphic, electronic,
audio or video matter, including journal advertisements, sales visual aids,
leave behind items, formulary binders, reprints, direct mail, direct-to consumer
advertising, Internet postings, broadcast advertisements and sales reminder aids
(for example, scratch pads, pens and other like items), in each case, created by
a Party or on its behalf and used or intended for use in connection with any
promotion of a Licensed Product in the Field in the Territory.

 

1.134“Public Official” means (a) any officer, employee or representative of any
regional, federal, state, provincial, county or municipal government or
government department, agency or other division; (b) any officer, employee or
representative of any enterprise that is owned or controlled by a government,
including any state-owned or controlled veterinary, laboratory or medical
facility; (c) any officer, employee or representative of any public
international organization, such as the International Monetary Fund, the United
Nations, or the World Bank; and (d) any person acting in an official capacity
for any government or government entity, enterprise, or organization identified
above; provided, however, that for the purposes of subclause (b), without regard
to how the applicable enterprise is owned or controlled by a government, any
person who will be deemed as a public official and subject to the same or
similar criminal penalties as are applicable to Public Officials under the
clause (a) under Applicable Law will be deemed Public Officials, including any
officer, employee, or representative of any national university corporations in
the Territory and JT.

 

1.135“Publication” has the meaning set forth in Section 9.6 (Publications).

 

1.136“Publication and Communication Strategy” has the meaning set forth in
Section 9.6 (Publications).

 

1.137“Receiving Party” has the meaning set forth in Section 9.1.1 (Duty of
Confidence).

 

1.138“Recipient” has the meaning set forth in Section 8.12.2 (Tax Cooperation).

 

1.139“Regulatory Approval” means, with respect to a particular country or other
regulatory jurisdiction, any approval of an MAA or other approval, product, or
establishment license, registration, or authorization of any Regulatory
Authority necessary for the commercial marketing or sale of a pharmaceutical or
biologic product in such country or other regulatory jurisdiction, excluding, in
each case, Reimbursement Approval.

 

1.140“Regulatory Authority” means any applicable Governmental Authority with
jurisdiction or authority over the Development, Manufacture, Commercialization,
or other Exploitation (including Regulatory Approval or Reimbursement Approval)
of pharmaceutical or biologic products in a particular country or other
regulatory jurisdiction, including the FDA, PMDA, MHLW, and any corresponding
national or regional regulatory authorities.

 

1.141“Regulatory Exclusivity” means, with respect to a particular Licensed
Product in the Field in the Territory, exclusive marketing rights conferred by a
Regulatory Authority with respect to such Licensed Product, excluding any rights
conferred by or based on any Patent Rights.

 

-15-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

1.142“Regulatory Responsibility Transfer Date” has the meaning set forth in
Section 3.4.1 (Regulatory Transfer).

 

1.143“Regulatory Responsible Party” means (a) BioCryst until the Regulatory
Responsibility Transfer Date and (b) Torii from and after the Regulatory
Responsibility Transfer Date; provided that, as between the Parties, BioCryst
will remain the Regulatory Responsible Party after the Regulatory Responsibility
Transfer Date to the extent that BioCryst is required by Applicable Law or any
Regulatory Authority in the Territory with respect to (i) BioCryst’s Manufacture
and supply of the Licensed Product for the Territory, and (ii) BioCryst’s
conduct of Development activities for the Licensed Product in the Field in the
Territory, including the submissions of any CTA.

 

1.144“Regulatory Submissions” means any filing, application, or submission with
any Regulatory Authority in support of Developing, Manufacturing, or
Commercializing a pharmaceutical or biologic product (including to obtain,
support, or maintain Regulatory Approval from that Regulatory Authority), and
all substantive correspondence or communication with or from the relevant
Regulatory Authority, as well as minutes of any substantive meetings, telephone
conferences, or discussions with the relevant Regulatory Authority. Regulatory
Submissions include all CTAs, MAAs, and other applications for Regulatory
Approval and Reimbursement Approvals and each of their equivalents.

 

1.145“Reimbursed Post-Marketing Expenses” has the meaning set forth in Section
3.1.2 (Post-Marketing Activities).

 

1.146“Reimbursement Approval” means an approval, agreement, determination, or
other decision by the applicable Governmental Authority that establishes prices
charged to end-users for pharmaceutical or biologic products at which a
particular pharmaceutical or biologic product will be reimbursed by the
Regulatory Authorities or other applicable Governmental Authorities in the
Territory.

 

1.147“Review Period” has the meaning set forth in Section 9.6 (Publications).

 

1.148“SAKIGAKE Designation” means the “sakigake” designation granted by the MHLW
to Integrated Development Associates for the Licensed Product on October 27,
2015, pursuant to Notification of MHLW (Yakushoku Shinsa Hatsu 0401 No. 6, dated
April 1, 2015).

 

1.149“SDE Agreement” has the meaning set forth in Section 3.6.2 (SDE
Agreements).

 

1.150“Second Failed Year” has the meaning set forth in Section 13.2.3 (Failure
to Achieve Performance Targets).

 

1.151“Seller” has the meaning set forth in Section 1.113 (Net Sales).

 

1.152“Serious Adverse Event” means an adverse drug experience or circumstance
that results in any of the following outcomes: (a) death, (b) life-threatening
condition, (c) inpatient hospitalization or a significant prolongation of
existing hospitalization, (d) persistent or significant disability or incapacity
or substantial disruption of the ability to conduct normal life functions, (e)
congenital anomaly or other birth defect, or (f) significant intervention
required to prevent permanent impairment or damage.

 

-16-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

1.153“Subcontractor” means a Third Party contractor engaged by a Party to
perform certain obligations or exercise certain rights of such Party under this
Agreement on a fee-for-service basis (including CMOs), excluding all
Sublicensees.

 

1.154“Sublicensee” means any Person (a) with respect to Torii, to whom Torii
grants a sublicense of, or other authorization or permission granted under, the
rights granted to Torii in Section 2.1 (License Grants to Torii), and (b) with
respect to BioCryst, to whom BioCryst grants a sublicense of, or other
authorization or permission granted under, the rights granted to BioCryst in
Section 2.3 (License Grants to BioCryst).

 

1.155“Supply Agreement” has the meaning set forth in Section 5.1.1 (Commercial
Supply).

 

1.156“Supply Failure” means the CMOs engaged by BioCryst’s failure to deliver
[***]; provided, however, that upon Torii’s reasonable request from and after
the [***] Launch Year, the Parties will review the definition of the Supply
Failure and discuss in good faith any adjustments to such definition that may be
necessary as a result of the actual volume and the frequency of supply of the
Licensed Product by BioCryst to Torii.

 

1.157“Tax” or “Taxes” means any present or future taxes, levies, imposts,
duties, charges, assessments or fees of any nature (including any interest
thereon), including value add taxes (“VAT”).

 

1.158“Tax Documents” has the meaning set forth in Section 8.1 (Upfront Payment).

 

1.159“Term” has the meaning set forth in Section 13.1 (Term).

 

1.160“Territory” means Japan.

 

1.161“Territory-Specific Packaging and Labeling” means those packaging and
labeling activities performed to package and label the Licensed Product in
finished, unlabeled form specifically for Commercialization purposes in the
Field in the Territory.

 

1.162“Territory Sponsor” means, with respect to a Clinical Trial for a Licensed
Product to be conducted at sites in the Territory, the Party that holds the CTA
from the applicable Regulatory Authority in the Territory for such Clinical
Trial in its name.

 

1.163“Third Party” means any Person other than a Party or an Affiliate of a
Party.

 

1.164“Third Party Claims” means collectively, any and all Third Party demands,
claims, actions, suits, and proceedings (whether criminal or civil, in contract,
tort, or otherwise).

 

1.165“Third Party Distributor” means any Third Party that purchases Licensed
Product from Torii or its Affiliates or Sublicensees, takes title to such
Licensed Product, and distributes such Licensed Product directly to customers,
but does not Develop or Manufacture any Licensed Product and does not make any
royalty, profit-share, or other payment to Torii or its Affiliates or
Sublicensees, other than payment for the purchase of Licensed Product for
resale.

 

1.166“Third Party IP Agreement” has the meaning set forth in Section 12.4.3
(Third Party IP Agreements).

 

1.167“Torii” has the meaning set forth in the Preamble.

 

-17-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

1.168“Torii Activities” means (a) the Torii Regulatory Activities (including all
Post-Marketing Activities from and after the Regulatory Responsibility Transfer
Date), (b) Commercialization performed solely in accordance with the applicable
Commercialization Plan, and (c) the Torii Development Activities performed
solely in accordance with the plan approved by the JSC, in each case ((a) –
(c)), with respect to the Licensed Product in the Field in the Territory.

 

1.169“Torii Collaboration Know-How” means any Know-How, including any Joint
Know-How, that (a) relates to the Licensed Product (including any composition of
matter, method of use, or method of Manufacturing, in each case, that is
specific to a species, genus, or generic class that includes the Licensed
Product), and (b) is developed or invented, whether solely or jointly with
others (including BioCryst), during the Term by Torii’s or its Controlled
Affiliates’, licensees’, Sublicensees’, or Subcontractors’ employees, agents, or
independent contractors, or any Person contractually required to assign or
license such Know-How (or Patent Rights Covering such Know-How) to Torii or any
Controlled Affiliate of Torii.

 

1.170“Torii Collaboration Patent Rights” means all Patent Rights Controlled by
Torii or any of its Controlled Affiliates that Covers any Torii Collaboration
Know-How.

 

1.171“Torii Collaboration Technology” means the Torii Collaboration Know-How and
the Torii Collaboration Patent Rights.

 

1.172“Torii Development Activities” has the meaning set forth in Section 4.1.4
(Other Development).

 

1.173“Torii Identified Rights” has the meaning set forth in Section 12.4.2
(Torii Identified Rights).

 

1.174“Torii Indemnitee(s)” has the meaning set forth in Section 11.2
(Indemnification; By BioCryst).

 

1.175“Torii Know-How” means all (a) Know-How that is (i) Controlled by Torii or
any of its Controlled Affiliates as of the Effective Date or during the Term,
and (ii) necessary or reasonably useful to Exploit the Licensed Product and (b)
Torii Collaboration Know-How.

 

1.176“Torii Manufacturing Activities” means (a) in the event of a Supply
Failure, Torii’s Manufacture (itself or through a Permitted Torii CMO) of the
Licensed Product in accordance with Section 5.6.4 (CMO Failure; Technology
Transfer), for the purpose of Commercializing the Licensed Product in the Field
in the Territory, (b) in the event of a BioCryst Inability to Supply, Torii’s
having the Licensed Product Manufactured for it by one or more CMOs previously
engaged by BioCryst in accordance with Section 5.6.3 (No CMO Failure) for the
purpose of Commercializing the Licensed Product in the Field in the Territory,
and (c) Territory-Specific Packaging and Labeling in accordance with Section
5.1.3 (Territory-Specific Packaging and Labeling).

 

1.177“Torii Patent Rights” means all (a) Patent Rights (excluding Torii’s
interest in Joint Patent Rights) that are (i) Controlled by Torii or any of its
Controlled Affiliates as of the Effective Date or during the Term, and (ii)
necessary or reasonably useful (or, with respect to patent applications, would
be necessary or reasonably useful if such patent applications were to issue as
patents) to Exploit the Licensed Product, and (b) all Torii Collaboration Patent
Rights.

 

1.178“Torii Regulatory Activities” has the meaning set forth in Section 3.1
(Development Responsibilities).

 

1.179“Torii Technology” means Torii Know-How, Torii Patent Rights, and Torii’s
interest in the Joint Technology.

 

-18-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

1.180“Transfer Price Patent Rights” means the BioCryst Patent Rights.

 

1.181“Transfer Price Payment Report” has the meaning set forth in Section 8.3.4
(Transfer Price Payment Reports and Payments).

 

1.182“Transfer Price Payment Term” has the meaning set forth in Section 8.3.2
(Transfer Price Payment Term).

 

1.183“Transfer Price Payments” has the meaning set forth in Section 8.3.1
(Transfer Price Rates).

 

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

 

1.185“Upfront Payment” has the meaning set forth in Section 8.1 (Upfront
Payment).

 

1.186“Valid Claim” means: (a) a claim of an issued and unexpired patent (as may
be extended through supplementary protection certificate or patent term
extension or the like) that has not been revoked, held invalid, or unenforceable
by a patent office or other Governmental Authority of competent jurisdiction in
a final and non-appealable judgment (or judgment from which no appeal was taken
within the allowable time period) and which claim has not been disclaimed,
denied, or admitted to be invalid or unenforceable through reissue,
re-examination, or disclaimer or otherwise; or (b) a pending claim of an
unissued, pending patent application, which application has not been pending for
more than [***] since the date of the first response on the merits received from
the relevant patent office regarding such application.

 

1.187“VAT” has the meaning set forth in Section 1.157 (Tax).

 

1.188“VAT Credit” has the meaning set forth in Section 8.12.5 (VAT Credits).

 

Article 2
LICENSES

 

2.1License Grants to Torii.

 

2.1.1Development and Commercialization License. Subject to the terms of this
Agreement (including BioCryst’s retained rights set forth in Section 2.5
(Retained Rights)), BioCryst hereby grants to Torii a royalty-bearing license,
with the right to grant sublicenses through multiple tiers solely in accordance
with Section 2.2 (Sublicensing and Subcontractors), under the BioCryst
Technology solely to perform the Torii Activities with respect to the Licensed
Product in the Field in the Territory. The license granted under this Section
2.1.1 (Development and Commercialization License) will be exclusive (even as to
BioCryst and its Affiliates) with respect to the Torii Regulatory Activities
(including all Post-Marketing Activities from and after the Regulatory
Responsibility Transfer Date) and Commercialization and non-exclusive with
respect to the Torii Development Activities.

 

2.1.2Manufacturing License. Subject to the terms of this Agreement (including
Section 2.1.3 (Covenant Not to Practice) and BioCryst’s retained rights set
forth in Section 2.5 (Retained Rights)), BioCryst hereby grants to Torii a
non-exclusive, fully-paid up license, with the right to grant sublicenses
through multiple tiers solely in accordance with Section 2.2 (Sublicensing and
Subcontractors) under the BioCryst Manufacturing Technology solely to perform
the Torii Manufacturing Activities.

 

-19-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

2.1.3Covenant Not to Practice. Notwithstanding any provision to the contrary set
forth in this Agreement, Torii will not Manufacture or have Manufactured the
Licensed Product anywhere in the world except (a) in the case of a BioCryst
Inability to Supply or Supply Failure following the occurrence of which Torii
has provided written notice to BioCryst in accordance with or Section 5.6.3 (No
CMO Failure) or Section 5.6.4 (CMO Failure; Technology Transfer) of its election
to Manufacture or have Manufactured (as applicable) the Licensed Product or (b)
to perform such activities related to Territory-Specific Packaging and Labeling
agreed by the JSC in accordance with Section 5.1.3 (Territory-Specific Packaging
and Labeling).

 

2.2Sublicensing and Subcontractors.

 

2.2.1Right to Sublicense. Subject to the terms of this Agreement, Torii will
have the right to grant sublicenses of the rights granted under Section 2.1
(License Grants to Torii) (a) without the prior consent of BioCryst (i) to its
Controlled Affiliates; provided that any such sublicense will automatically
terminate if such Person ceases to be a Controlled Affiliate of Torii, and (ii)
to the extent necessary for a Subcontractor to perform Torii’s applicable
obligations or exercise Torii’s applicable rights hereunder, to Subcontractors
engaged in accordance with Section 2.2.2 (Right to Subcontract), and (b) with
BioCryst’s prior written consent (not to be unreasonably withheld), to any other
Third Party. Notwithstanding any provision to the contrary set forth in this
Agreement, Torii will not grant a sublicense to any Third Party (including a
Subcontractor) of all or substantially all of Torii’s rights or obligations
under this Agreement with respect to the Territory without BioCryst’s prior
written consent. Each Sublicensee will hold its rights contingent on the rights
licensed to Torii under the terms of this Agreement. Any termination of the
licenses granted to Torii under Section 2.1 (License Grants to Torii) as a
result of a termination of this Agreement in its entirety will cause each
agreement with any Sublicensee to automatically terminate.

 

2.2.2Right to Subcontract. Subject to Section 2.2.1 (Right to Sublicense),
Section 2.2.4 (Terms of Sublicenses and Subcontracting Agreements), and Section
2.2.6 (Responsibility for Sublicensees and Subcontractors) and the remainder of
this Section 2.2.2 (Right to Subcontract), Torii may engage one or more
Subcontractors to perform its obligations or exercise its rights under this
Agreement without BioCryst’s consent; provided that Torii may only engage a CMO
to Manufacture the Licensed Product that is either (a) a CMO engaged by BioCryst
to Manufacture the Compound or the Licensed Product, (b) a CMO located in the
Territory to perform Territory-Specific Packaging and Labeling or in the event
of a Supply Failure, to Manufacture the Licensed Product for Commercialization
purposes in the Field in the Territory, or (c) otherwise approved in advance by
BioCryst, such approval not to be unreasonably withheld (the CMOs described in
the foregoing clauses ((a) – (c)), the “Permitted Torii CMOs”).

 

2.2.3Notice of Sublicenses. Torii will provide BioCryst with a true and complete
copy of each sublicense agreement with any Third Party no later than [***] after
it becomes effective, subject to Torii’s right to redact any confidential or
proprietary information contained therein that is not necessary for BioCryst to
determine the scope of the rights granted under such sublicense or compliance
with the terms of this Agreement.

 

2.2.4Terms of Sublicenses and Subcontracting Agreement. To be valid, each
agreement with a Sublicensee or other Subcontractor must be in writing,
consistent with the terms of this Agreement and include terms that (a) require
each such Sublicensee or other Subcontractor to comply with the terms of this
Agreement that are applicable to such Sublicensee or other Subcontractor
(including (i) obligations of confidentiality and non-use at least as stringent
as those set forth in Article 9 (Confidentiality; Publication), and (ii) the
intellectual property provisions set forth in Article 12 (Intellectual
Property)), and (b) solely in any agreement with a Sublicensee, preclude the
granting of further sublicenses. Further, solely in any agreement with a
Sublicensee, Torii will use reasonable efforts to include BioCryst as an
intended third party beneficiary under the sublicense with the right to enforce
the applicable terms of such agreement. In addition, if Torii is unable to
include BioCryst as a third party beneficiary in any such sublicense, then upon
BioCryst’s reasonable request, Torii will use reasonable efforts to enforce the
terms of any such sublicense agreement against any Sublicensee that has breached
such agreement in a manner that adversely affects BioCryst. In addition, upon
BioCryst’s reasonable request, Torii will enforce the terms of any agreement
with a Sublicensee or other Subcontractor against such Sublicensee or
Subcontractor to the extent applicable to the performance of Torii’s obligations
under this Agreement. Without limiting the generality of the foregoing, each
sublicense agreement or subcontracting agreement with the applicable Third Party
entered into after the Effective Date must include (A) an assignment or
sublicenseable license back to Torii of all Know-How and Patent Rights
developed, invented, or filed (as applicable) by or on behalf of the Sublicensee
that are necessary or reasonably useful to Exploit the Licensed Product (such
that Torii Controls such Know-How and Patent Rights for the purposes of this
Agreement), and (B) a provision preventing such Third Party from engaging in,
independently or for or with any other Third Party, any Exploitation of any
Competitive Product in the Territory (which provision Torii will enforce against
all Sublicensees and Subcontractors). Any purported sublicense that does not
comply with the foregoing requirements will be void and unenforceable.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

2.2.5Torii Audits of Sublicensees and Subcontractors. Torii will provide
BioCryst with copies of any quality oversight or audit reports from audits that
Torii (or its agent) has conducted on any Sublicensees or Subcontractors that
Torii engages to perform its obligations or exercise its rights under this
Agreement to the extent such reports are relevant to such Sublicensees’ or
Subcontractors’ performance of such obligations or exercise of such rights no
later than [***] after receiving or preparing, as applicable, any such report.

 

2.2.6Responsibility for Sublicensees and Subcontractors. Torii will require that
all Sublicensees and Subcontractors perform the activities that they are
sublicensed or engaged to perform (as applicable) in accordance with GLP, cGMP,
and GCP, as applicable, and otherwise in compliance with Applicable Law.
Notwithstanding the grant of any sublicense or engagement of any Subcontractor,
Torii will remain primarily liable to BioCryst for the performance of all of its
obligations under, and Torii’s compliance with all provisions of, this
Agreement. Torii will be fully responsible and liable for any breach of the
terms of this Agreement by any of its Sublicensees or Subcontractors to the same
extent as if Torii itself has committed any such breach and will terminate
promptly the agreement with any Sublicensee or Subcontractor if such Sublicensee
or Subcontractor Defaults under this Agreement and does not cure such Default in
a timely manner.

 

2.3License Grants to BioCryst.

 

2.3.1Exclusive License. Subject to the terms of this Agreement (including
Torii’s retained rights set forth in Section 2.5 (Retained Rights)), Torii
hereby grants to BioCryst an exclusive, royalty-free license, with the right to
grant sublicenses through multiple tiers, under the Torii Technology solely to
Exploit the Licensed Product outside of the Territory (both inside and outside
the Field) and in the Territory outside of the Field.

 

-21-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

2.3.2Non-Exclusive License. Subject to the terms of this Agreement, Torii hereby
grants to BioCryst a non-exclusive perpetual, irrevocable, royalty-free license,
with the right to grant sublicenses through multiple tiers under the Torii
Collaboration Technology solely to (a) perform Development and Manufacturing
activities for the Licensed Product in the Territory, (b) during the Term to
perform BioCryst’s obligations and exercise BioCryst’s rights under this
Agreement, and (c) Exploit any products Controlled by BioCryst or any of its
Affiliates (including the Licensed Products) worldwide.

 

2.4Reciprocal Sublicensing. Notwithstanding any provision to the contrary set
forth in this Agreement, BioCryst will only grant its other licensees with
respect to the Licensed Product a sublicense under the license granted to
BioCryst in Section 2.3.1 (Exclusive License) if such licensees have granted
BioCryst a license that is sublicensed to Torii under this Agreement allowing
Torii to practice such other licensees’ intellectual property relating to the
Licensed Product to the same extent as BioCryst has such right for no monetary
or in-kind consideration (unless BioCryst bears responsibility for any
additional monetary or in-kind consideration due to such licensee in
consideration for such sublicensed rights).

 

2.5Retained Rights. Nothing in this Agreement will be interpreted to grant a
Party any rights under any intellectual property rights owned or Controlled by
the other Party, including BioCryst Technology or Torii Technology, in each
case, that are not expressly granted herein, whether by implication, estoppel,
or otherwise. Any rights not expressly granted to BioCryst by Torii under this
Agreement are hereby retained by Torii. Any rights not expressly granted to
Torii by BioCryst under this Agreement are hereby retained by BioCryst,
including the right (on behalf of itself and its licensees, other than Torii,
and Sublicensees) to (a) Manufacture the Licensed Product both inside and
outside the Territory, (b) perform Development activities for the Licensed
Product both inside and outside the Territory, (c) perform BioCryst’s other
obligations and exercise BioCryst’s rights under this Agreement, and (d) outside
of the Territory and in the Territory outside of the Field, subject to the
restrictions under this Agreement, Exploit the Licensed Product. Torii will not
practice the BioCryst Technology other than as expressly licensed and permitted
under this Agreement or otherwise agreed by the Parties in writing.

 

2.6Exclusivity Covenant. During the period commencing on the Effective Date and
ending upon the earlier of: (a) the end of the [***] or (b) expiration or
termination of this Agreement, Torii will not, and will ensure that its
Affiliates do not, independently or for or with any Third Party, directly or
indirectly, Exploit or grant rights to any Third Party under any BioCryst
Technology or Torii Technology to Exploit any Competitive Product. During the
period commencing as of the start of the [***] and ending upon the end of the
[***], Torii will not, and will ensure that its Affiliates do not, independently
or for or with any Third Party, directly or indirectly, market, promote or sell
or grant rights to any Third Party under any BioCryst Technology or Torii
Technology to market, promote or sell any Competitive Product.

 

2.7Right of First Negotiation.

 

2.7.1Field Expansion ROFN. Although the continued Development of the Licensed
Product in HAE-A is at BioCryst’s sole discretion, if BioCryst does continue to
Develop the Licensed Product in HAE-A, then Torii would be BioCryst’s preferred
partner for Commercializing the Licensed Product in that Indication in the
Territory. Accordingly, if BioCryst determines to continue Developing the
Licensed Product in HAE-A, then BioCryst will, no later than [***]), notify
Torii of the data from such Clinical Trial and its opportunity to negotiate with
BioCryst to expand the Field hereunder to include HAE-A (the “Field Expansion
Notice”). Thereafter, Torii will have a right, exercisable no later than [***]
after receipt of any such Field Expansion Notice from BioCryst, to notify
BioCryst in writing as to whether Torii desires to negotiate for the right to
expand the Field hereunder to include HAE-A in the Territory (the “Field
Expansion Exercise Notice”). If Torii provides a Field Expansion Exercise Notice
to BioCryst within such [***] period indicating its desire to negotiate for such
rights to the Licensed Product in HAE-A in the Territory, then Torii will have a
one-time right for [***] from the date of BioCryst’s receipt of the Field
Expansion Exercise Notice (the “Field Expansion Negotiation Period”) to
negotiate exclusively with BioCryst in good faith the financial and other terms
of this Agreement that the Parties would amend in consideration for expanding
the Field to include HAE-A, including each Party’s roles, responsibilities, and
financial obligations with respect to further Development of the Licensed
Product. If the Parties so agree to such an amendment, then the Field will be
automatically expanded to include HAE-A, and authorized representatives of each
Party will execute such amendment in accordance with Section 15.9 (Entire
Agreement; Amendments). During the Field Expansion Negotiation Period, unless
Torii provides written notice to BioCryst terminating further negotiations, (a)
BioCryst will negotiate in good faith exclusively with Torii with respect to the
terms on which the Field would be expanded to include HAE-A, and (b) BioCryst
will not negotiate, offer to enter into, or enter into an agreement with a Third
Party with respect to a grant of rights to Commercialize such Licensed Product
in HAE-A in the Territory.

 

-22-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

2.7.2Alternative Products ROFN. With respect to a product Controlled by BioCryst
or its Affiliates for use in HAE (including, for purposes of this section, HAE-A
and HAE-P) other than a Licensed Product (each, a “Alternative Product”), upon
the earlier of (a) [***], then BioCryst will notify Torii of its opportunity to
negotiate with BioCryst with respect to a license to Commercialize such
Alternative Product in HAE in the Territory. Thereafter, Torii will have a
right, exercisable no later than [***] after receipt of any such written notice
from BioCryst, to notify BioCryst in writing as to whether Torii desires to
negotiate for the right to Commercialize such Alternative Products in HAE in the
Territory (the “Alternative Products License Exercise Notice”). If Torii
provides an Alternative Products License Exercise Notice to BioCryst within such
[***] period indicating its desire to negotiate for such rights to the
Alternative Products in HAE in the Territory, then Torii will have the right for
[***] from the date of BioCryst’s receipt of the Alternative Products License
Exercise Notice (the “Alternative Products License Negotiation Period”) to
negotiate exclusively with BioCryst in good faith the financial and other terms
upon which Torii would be granted rights to Commercialize such Alternative
Product in HAE in the Territory, including, if applicable in the event of an
Alternative Product that is a combination product, appropriate licenses or
allocation of Net Sales as a result of any Know-How or Patent Rights Controlled
by a Third Party included in the Alternative Product. During the Alternative
Products License Negotiation Period, unless Torii provides written notice to
BioCryst terminating further negotiations, (i) BioCryst will negotiate in good
faith exclusively with Torii with respect to the terms of a license to
Commercialize the Alternative Products in HAE in the Territory, and (ii)
BioCryst will not negotiate, offer to enter into, or enter into an agreement
with, a Third Party with respect to a grant of rights to Commercialize such
Alternative Product in HAE in the Territory.

 

2.7.3Failure to Exercise or Agree. If either (a) Torii does not provide the
Field Expansion Exercise Notice or the Alterative Products License Exercise
Notice (as applicable) to BioCryst within the applicable [***] period or (b)
Torii terminates the Field Expansion Negotiation Period or the Alternative
Products License Negotiation Period (as applicable) in writing, then, in each
case ((a), or (b)), BioCryst will have no obligation to negotiate with Torii any
further with respect to the expansion of the Field to include HAE-A or a grant
of rights to Commercialize the applicable Alternative Product in HAE in the
Territory. If instead, Torii provides the Field Expansion Exercise Notice or the
Alternative Products License Exercise Notice (as applicable) to BioCryst within
the applicable time period, but Torii and BioCryst do not agree on terms under
which the Field would be expanded to include HAE-A within the applicable Field
Expansion Negotiation Period or the terms on which Torii would be granted rights
to Commercialize such Alternative Product in HAE in the Territory during the
Alternative Products License Negotiation Period, in each case, after having
conducted such negotiations in good faith, then the terms of Section 2.7.4
(License Arbitration) will apply.

 

-23-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

2.7.4License Arbitration. If the Parties cannot reach agreement on the terms
under which the Field would be expanded to include HAE-A within the applicable
Field Expansion Negotiation Period or the terms on which Torii would be granted
rights to Commercialize the applicable Alternative Product in HAE in the
Territory during the Alternative Products License Negotiation Period, then, in
each case, the financial, commercial, and legal terms of the agreement pursuant
to which BioCryst would grant to Torii the applicable rights pursuant to Section
2.7.1 (Field Expansion ROFN) or Section 2.7.2 (Alternative Products ROFN), as
applicable, will be determined through binding arbitration as follows:

 

(a)Arbitration Drafts. Within [***] from the end of the Field Expansion
Negotiation Period or the Alternative Products License Negotiation Period (as
applicable), each Party will (i) prepare a proposed draft of the definitive
agreement (including its proposed economic terms) pursuant to which BioCryst
would grant Torii such rights pursuant to Section 2.7.1 (Field Expansion ROFN)
or Section 2.7.2 (Alternative Products ROFN), as applicable, to be used in such
arbitration proceeding (each, an “Arbitration Draft”) and (ii) submit its
Arbitration Draft to the other Party. Within [***] of the submission of the
latter of such Arbitration Drafts, the Parties will meet to determine whether
they agree to enter into either Party’s Arbitration Draft or a modified version
thereof in consideration of the grant of the applicable rights.

  

(b)Arbitration for Financial Terms. If the Parties are unable to agree to enter
into an amendment to the Agreement or other arrangement with respect to the
applicable grant of rights pursuant to Section 2.7.4(a) (Arbitration Drafts)
within the [***] period set forth therein, then Torii, in its sole discretion,
may require the arbitrators to be appointed in accordance with the provisions of
Section 14.3 (Arbitration) and, within [***] after the appointment of such
arbitrators, each Party will submit its Arbitration Draft to the arbitrators for
determination. If Torii does not so require the arbitrators to be appointed
prior to the expiration of such [***] period or, prior to the expiration of such
[***] period provides written notice to BioCryst that it will not require such
arbitrators to be so appointed, then, in either case, Torii will not be granted
any rights to expand the Field to include HAE-A or to Commercialize the
Alternative Product in HAE in the Territory, as applicable, and from and after
such date the terms of Section 2.7.1 (Field Expansion ROFN) or Section 2.7.2
(Alternative Products ROFN), as applicable, will no longer apply. The
arbitrators will be instructed to select one of the Parties’ Arbitration Drafts
within [***] following the receipt of the latter of such Arbitration Drafts and
to select the draft that she or he determines to contain terms that most closely
align with the fair market value of the applicable rights being granted to Torii
and contain the most commercially reasonable, customary, and fair commercial and
legal terms. Such decision will be made in accordance with the provisions of
Section 14.3 (Arbitration); provided that the arbitrators will be limited to
selecting only one or the other of the Arbitration Drafts submitted by the
Parties. The selection by the arbitrators of one Party’s Arbitration Draft will
be binding and conclusive upon both Parties and their Affiliates (in case of
BioCryst) or Controlled Affiliates (in case of Torii).

  

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

(c)Arbitration Fee and Costs. The fees of the arbitrator will be shared equally
(on a 50:50 basis) by the Parties, and each Party will be responsible for all
other costs and expenses incurred by such Party in connection with the
arbitration.

 

 

Article 3
REGULATORY

 

 

3.1Regulatory Responsibilities.

 

3.1.1In the Territory. Prior to the Regulatory Responsibility Transfer Date,
subject to this Section 3.1.1 (Regulatory; In the Territory) and Section 3.1.2
(Post Marketing Activities), BioCryst, itself or through its designee, at its
sole cost and expense, will be the Regulatory Responsible Party and accordingly
will have sole control over and decision-making authority with respect to
regulatory activities with respect to the Licensed Product in the Territory,
including the filings of all MAAs, applications for Reimbursement Approvals, and
other Regulatory Submissions and all Post-Marketing Activities. From and after
the Regulatory Responsibility Transfer Date, other than to the extent that
BioCryst is required by Applicable Law or Regulatory Authorities in the
Territory with respect to (a) BioCryst’s Manufacture and supply of the Licensed
Product for the Territory, or (b) BioCryst’s conduct of Development activities
for the Licensed Product in the Territory, including the submissions of any CTA
(with respect to each of which activities set forth in the foregoing clauses (a)
and (b) BioCryst will remain the Regulatory Responsible Party). Torii, itself or
through its designee, at its sole cost and expense, will be the Regulatory
Responsible Party and accordingly will have sole control over, sole
decision-making with respect to, and sole responsibility for performing, all
regulatory activities for the Licensed Product in the Field in the Territory,
including the preparation and submission of all further Regulatory Submissions
necessary or desirable for obtaining, supporting, or maintaining all Regulatory
Approvals and Reimbursement Approvals for the Licensed Product in the Field in
the Territory and all Post-Marketing Activities (the “Torii Regulatory
Activities”).

 

3.1.2Post-Marketing Activities. On an annual basis, the Regulatory Responsible
Party will submit the then-current protocols for Post-Marketing Activities to
the JSC to review and discuss. Notwithstanding any provision to the contrary set
forth in this Agreement, at all times during the Term, Torii will be responsible
for all costs and expenses associated with the performance of Post-Marketing
Activities for the Licensed Product in the Field in the Territory, including
those performed by or on behalf of BioCryst prior to or after the Regulatory
Responsibility Transfer Date. Accordingly, to the extent such costs and expenses
for the performance of Post-Marketing Activities by or on behalf of BioCryst are
(a) within [***] of the budget for the internal costs (at the FTE Rate) and
external expenses for the performance of Post-Marketing Activities by or on
behalf of BioCryst (the “Post-Marketing Budget”) approved by the JSC from time
to time or (b) otherwise approved in writing by the JSC ((a) and (b),
collectively, the “Reimbursed Post-Marketing Expenses”), BioCryst will invoice
Torii for all Reimbursed Post-Marketing Expenses, and Torii will pay the
undisputed invoiced amounts within [***] after the date of the invoice.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

3.1.3BioCryst Assistance Inside the Territory and Field. Without limiting
Section 3.5 (Right of Reference), BioCryst will reasonably and in a timely
manner cooperate with Torii in its efforts to perform the Torii Regulatory
Activities, including by providing to Torii reasonably requested data and
documentation related to such Licensed Product in the Field in the Territory
generated by or on behalf of BioCryst or its Controlled Affiliates (which
assistance and data generation must be in accordance with Applicable Law in the
Territory) as well as any samples and materials as provided in Section 12.5.3
(Data Exchange and Use). Torii will be responsible for all reasonable internal
costs or external expenses incurred by or on behalf of BioCryst to the extent
necessary to obtain data, conduct analysis, or create formatting solely for the
Field in the Territory and any translation costs associated with any of the
foregoing and BioCryst will be responsible for all other internal costs and
external expenses incurred in connection with providing such assistance to Torii
(to the extent reasonably requested). Accordingly, BioCryst will invoice Torii
for the foregoing costs and expenses associated with the performance of such
assistance as set forth under this Section 3.1.3 (BioCryst Assistance Inside the
Territory and Field), and Torii will pay the undisputed invoiced amounts within
[***] after the date of the invoice.

 

3.1.4Torii Assistance Outside the Territory and Field. Without limiting Section
3.5 (Right of Reference), Torii will reasonably cooperate and in a timely manner
to assist BioCryst in its efforts to prepare and submit any Regulatory
Submissions to obtain, support, or maintain Regulatory Approvals and
Reimbursement Approval for the Licensed Product outside of the Territory or in
the Territory outside of the Field, including by providing to BioCryst
reasonably requested data and documentation related to such Licensed Product
generated by or on behalf of Torii or its Controlled Affiliates (which
assistance and data generation must be in accordance with Applicable Law) as
well as any necessary samples and materials as provided in Section 12.5.3 (Data
Exchange and Use). BioCryst will be responsible for all reasonable internal
costs (at the FTE Rate) or external expenses incurred by or on behalf of Torii
solely to obtain data, conduct analysis, or create formatting, in each case,
solely for use outside of the Territory or in the Territory outside of the Field
and any translation costs associated with any of the foregoing and Torii will be
responsible for all other internal costs incurred in connection with providing
such assistance to BioCryst (to the extent reasonably requested). Accordingly,
Torii will invoice BioCryst for the foregoing costs and expenses associated with
the performance of such assistance as set forth under this Section 3.1.4 (Torii
Assistance Outside the Territory and Field), and BioCryst will pay the
undisputed invoiced amounts within [***] after the date of the invoice.

 

3.2Regulatory Diligence Activities. The Regulatory Responsible Party will use
Commercially Reasonable Efforts to obtain and maintain all Regulatory Approvals
and Reimbursement Approvals required to Commercialize the Licensed Product in
the Field in the Territory.

 

3.3Filings and Correspondence.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

3.3.1Regulatory Submissions. Subject to the terms of this Agreement, the
applicable Regulatory Responsible Party will be responsible for the preparation
and submission of all Regulatory Submissions for the Licensed Product in the
Field in the Territory. The Regulatory Responsible Party will provide the other
Party with an opportunity to review and comment on all substantive Regulatory
Submissions to be submitted to any Regulatory Authority in the Territory by or
on behalf of the Regulatory Responsible Party for the Licensed Product in the
Field in the Territory. The Regulatory Responsible Party will, and will cause
its Affiliates and Sublicensees to, consider in good faith and implement all
reasonable comments thereon from the other Party that are provided in a timely
manner so as to meet the applicable submission or response deadline for such
Regulatory Submission. The non-Regulatory Responsible Party will cooperate fully
and in a timely manner to reasonably assist the Regulatory Responsible Party in
its efforts to prepare and submit those Regulatory Submissions required to
obtain, support, or maintain any Regulatory Approvals or Reimbursement Approvals
for the Licensed Product in the Field in the Territory.

 

3.3.2Correspondence with Authorities. Except as otherwise set forth in this
Agreement, and without limiting Section 3.3.1 (Regulatory Submissions), promptly
following the Regulatory Responsible Party’s receipt, forwarding, or production
thereof, the Regulatory Responsible Party will provide the other Party with (a)
access to or copies of all material written or electronic correspondence and
communications (other than Regulatory Submissions) received by the Regulatory
Responsible Party or its Affiliates or Sublicensees from, or forwarded by the
Regulatory Responsible Party or its Affiliates or Sublicensees to, the
Regulatory Authorities in the Territory, and (b) copies of all meeting minutes
and summaries of all meetings, conferences, and discussions held by the
Regulatory Responsible Party or its Affiliates or Sublicensees with the
Regulatory Authorities in the Field in the Territory. If such written or
electronic correspondence received from any such Regulatory Authority relates to
the prohibition or suspension of the supply of a Licensed Product, or the
initiation of any investigation, review, or inquiry by such Regulatory Authority
concerning the safety of a Licensed Product, then the Regulatory Responsible
Party will notify the other Party and provide the other Party with copies of
such written or electronic correspondence as soon as practicable, but not later
than [***] after receipt of such correspondence.

 

3.3.3Meetings with Regulatory Authorities. Except as otherwise set forth in this
Agreement, the applicable Regulatory Responsible Party will be responsible for
all meetings, conferences, and discussions with Regulatory Authorities or other
applicable Governmental Authorities related to the receipt of Regulatory
Approval to Commercialize the Licensed Product in the Field in the Territory.
The Regulatory Responsible Party will provide the other Party with written
notice of any scheduled material meeting, conference, or discussion with a
Regulatory Authority or other Governmental Authority in the Territory relating
to the Licensed Product in the Field as soon as practicable and, upon such other
Party’s request, will, to the extent practicable and permitted by the
Governmental Authority in the Territory, allow such other Party to attend such
meeting, conference, or discussion. The Regulatory Responsible Party will
provide to the other Party copies of any correspondence relating to such
meetings, conferences, or discussions, including meeting requests, briefing
materials or questions no later than as soon as practically possible after the
Regulatory Responsible Party’s receipt thereof, and in any event no later than
[***] following the date of such correspondence.

 

3.3.4Ownership of Regulatory Approvals. The Regulatory Responsible Party will
file all MAAs and applications for Reimbursement Approval for the Licensed
Product in the Field in the Territory in its name, and, subject to the
assignments set forth in Section 3.4 (Transfer of Regulatory Materials) and the
rights granted to Torii under Section 2.1 (License Grants to Torii), will own
all rights, title, and interests in and to all resulting Regulatory Approvals
and Reimbursement Approvals for the Licensed Product in the Field in the
Territory and all related Regulatory Submissions. The Regulatory Responsible
Party will promptly inform the other Party (and in any event no later than [***]
after receipt) of (a) the filing of any MAA for the Licensed Product in the
Field in the Territory, and (b) the receipt of any Regulatory Approval or
Reimbursement Approval for a Licensed Product in the Field in the Territory.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

3.4Transfer of Regulatory Materials.

 

3.4.1Regulatory Transfer. On the date that is one (1) year after the First
Commercial Sale of the first Licensed Product in the Field in the Territory or
any other dates agreed in writing by the Parties, BioCryst will, or will cause
its designee to, transfer and assign to Torii all rights, title, and interests
in and to all Regulatory Approvals, Reimbursement Approvals, and all other
Regulatory Submissions required under Applicable Law in the Territory to be held
by Torii related to Commercialization of the Licensed Product in the Field in
the Territory in the possession and Control of BioCryst, its Affiliates, or
designees (the “Assigned Regulatory Materials”), including copies of all such
Assigned Regulatory Materials in electronic format, or such other format
maintained by BioCryst or its designee or otherwise agreed by the Parties, to
the extent the same have not been previously made available to Torii. The
Parties will discuss the detailed timeline and each Party’s roles and
responsibilities through the JSC and will consult with applicable Regulatory
Authorities regarding such assignment and transfer sufficiently in advance of
the Regulatory Responsibility Transfer Date. The date specified in Torii’s
appropriate Regulatory Submission to the PMDA as the date on which Torii will
(a) become responsible to the PMDA and the MHLW under all Regulatory Approvals
and Reimbursement Approvals for the Licensed Product in the Field in the
Territory and for all regulatory activities and Regulatory Submissions with
respect thereto and (b) accordingly become the Regulatory Responsible Party for
the Licensed Product in the Field in the Territory will be the “Regulatory
Responsibility Transfer Date” for purposes of this Agreement.

 

3.4.2Cooperation. Subject to the terms of this Agreement, upon a Party’s written
request, the other Party will execute and deliver, or will cause to be executed
and delivered, to the requesting Party such endorsements, assignments,
commitments, acknowledgements, and other documents as may be necessary (a) to
assign, convey, transfer, and deliver to Torii all of BioCryst’s or its
applicable Affiliate’s or designee’s rights, title, and interests in and to the
applicable Assigned Regulatory Materials, (b) to otherwise assume the
responsibilities as the Regulatory Responsible Party under this Agreement, or
(c) as a result of the transfer to Torii of the Assigned Regulatory Materials,
including submitting to each applicable Regulatory Authority or other
Governmental Authority in the Territory a letter or other necessary
documentation (with copy to the other Party) notifying such Regulatory Authority
or other Governmental Authority of, or otherwise giving effect to, the transfer
of ownership to Torii of the Assigned Regulatory Materials, Reimbursement
Approvals, and other Regulatory Submissions for the Licensed Product in the
Field in the Territory as provided in Section 3.4.1 (Regulatory Transfer).

 

3.4.3Costs. [***] will bear all Third Party expenses in connection with (a) the
transfer and assignment of all Assigned Regulatory Materials, and any other
copies of any Regulatory Approvals, Reimbursement Approvals, or other Regulatory
Submissions for the Licensed Product in the Field in the Territory provided to
Torii pursuant to this Section 3.4 (Transfer of Regulatory Materials), and (b)
the performance of any other activities required for Torii to assume the role of
Regulatory Responsible Party with respect to the Licensed Product in the Field
in the Territory or as may be required as a result of the transfer to Torii of
the Assigned Regulatory Materials.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

3.5Right of Reference. Each Party will grant, and hereby does grant, to the
other Party a right of reference to all Regulatory Submissions pertaining to the
Licensed Product in the Field in the Territory submitted by or on behalf of such
Party or its Affiliates (in case of BioCryst) or Controlled Affiliates (in case
of Torii). Torii may use such right of reference to BioCryst’s Regulatory
Submissions solely for the purpose of seeking, obtaining, supporting, and
maintaining Regulatory Approvals and any Reimbursement Approvals, as applicable,
for the Licensed Product in the Field in the Territory in accordance with the
terms of this Agreement following the Regulatory Responsibility Transfer Date.
BioCryst may use such right of reference to Torii’s Regulatory Submissions
solely for the purpose of seeking, obtaining, supporting, and maintaining
Regulatory Approval and any Reimbursement Approvals of the Licensed Product
outside of the Territory or in the Territory outside of the Field. Each Party
will bear its own costs and expenses associated with providing the other Party
the right of reference pursuant to this Section 3.5 (Right of Reference). Each
Party will take such actions as may be reasonably requested by the other Party
to give effect to the intent of this Section 3.5 (Right of Reference) and to
give the other Party the benefit of the granting Party’s Regulatory Submissions
as provided herein. Such actions may include (a) providing to the other Party
copies of correspondence and communications received from the applicable
Regulatory Authorities or other Governmental Authorities related to such Party’s
MAAs or applications for Reimbursement Approval for the Licensed Product in the
Field in the Territory (if Torii is the Party seeking Regulatory Approval or
Reimbursement Approval) and of the Licensed Product outside of the Territory or
in the Territory outside of the Field (if BioCryst is the Party seeking
Regulatory Approval or Reimbursement Approval), or (b) providing the other Party
with any underlying raw data or information submitted by the granting Party to
the Regulatory Authority with respect to any Regulatory Submissions Controlled
by such granting Party or its Controlled Affiliates that relates to the Licensed
Product in the Field in the Territory. Notwithstanding any provision to the
contrary set forth in this Agreement, BioCryst will only allow its other
licensees the rights to cross-reference Torii’s regulatory filings granted under
this Section 3.5 (Right of Reference) if such licensees have agreed to permit
BioCryst to allow Torii the right to cross-reference such other licensees’
regulatory filings (including clinical data) for no monetary or in-kind
consideration (unless BioCryst bears responsibility for any additional monetary
or in-kind consideration due to such licensee in consideration for such rights
to cross-reference).

 

3.6Adverse Events Reporting.

 

3.6.1Adverse Event Reporting. Within a reasonable period of time prior to the
First Commercial Sale of the Licensed Product in the Field in the Territory, the
Parties will notify each other in writing of the names and contact information
of their respective employees or agents who are responsible for adverse
experience reporting.

 

3.6.2Safety Data Exchange (SDE) Agreements. No later than [***] prior to the
First Commercial Sale of a Licensed Product in the Field in the Territory, the
Parties will enter into one or more written agreements setting forth worldwide
safety and pharmacovigilance procedures for the Parties with respect to the
Licensed Product in the Field (a “SDE Agreement”). Torii will not market,
promote, sell, or otherwise Commercialize the Licensed Product unless and until
the Parties enter into one or more SDE Agreements for the Licensed Product. Each
SDE Agreement will describe the obligations of both Parties with respect to the
coordination of collection, investigation, reporting, and exchange of
information between the Parties concerning any adverse event experienced by a
subject or patient, and the seriousness thereof, whether or not determined to be
attributable to the Licensed Product, including any such information received by
either Party from a Third Party (subject to receipt of any required consents
from such Third Party) and will be sufficient to permit each Party and its
Affiliates (in case of BioCryst) or Controlled Affiliates (in case of Torii),
licensees, or Sublicensees (as applicable) to comply with its legal obligations
with respect thereto, including each Party’s obligations as the owner or holder
of Regulatory Approvals and Regulatory Submissions for such Licensed Product in
the Territory, as applicable. Each SDE Agreement will also detail each Party’s
responsibilities with respect to the maintenance of a safety database and the
other Party’s rights to access and query such database, it being understood that
BioCryst will maintain the global safety database for the Licensed Product, and
each Party’s responsibilities for recalls and withdrawals of the Licensed
Product inside and outside of the Territory and inside and outside of the Field.
If required by changes in Applicable Law, the Parties will make appropriate
updates to the applicable SDE Agreements. Each Party will comply with its
respective obligations under each SDE Agreement and cause its Controlled
Affiliates and Sublicensees to comply with such obligations. Notwithstanding any
provision to the contrary in this Agreement or any SDE Agreement, each Party and
its Controlled Affiliates, licensees, and Sublicensees will have the right to
disclose information related to the safety of the Licensed Product to the extent
that such disclosure is required for such Party to comply with its obligations
under Applicable Law or the safety requirements of the applicable Regulatory
Authorities. The Parties will cooperate with each other to address any
safety-related inquiries or requests for safety assessment by any Regulatory
Authority, including providing any necessary data or information in a timely
manner. To the extent that there is a conflict between the terms of this
Agreement and the terms of any SDE Agreement, the terms of the applicable SDE
Agreement will govern with respect to the subject matter set forth therein.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

3.7Regulatory Audits. Prior to the Regulatory Responsibility Transfer Date, as
the holder of the Regulatory Approval for the Licensed Product in the Field in
the Territory, BioCryst or its representatives will be entitled to conduct
audits of safety and regulatory systems, procedures, practices, or records of
Torii or its Controlled Affiliates or Sublicensees relating to the Licensed
Product. With respect to any inspection of Torii or its Controlled Affiliates or
Sublicensees by any Governmental Authority relating to the Licensed Product,
Torii will notify BioCryst of such inspection (a) no later than [***] after
Torii receives notice of such inspection (or in any event with as much advanced
notice as is possible prior to such inspection if Torii receives notice thereof
less than two Business Days in advance of the applicable inspection) or (b)
within [***] after the completion of any such inspection of which Torii did not
receive prior notice. Torii will promptly provide BioCryst with all information
related to any such inspection. BioCryst will have the right, but not the
obligation (unless required by Applicable Law or any Governmental Authority), to
be present at any such regulatory inspection. Following any such regulatory
inspection related to the Licensed Product in the Territory, Torii will provide
BioCryst with (i) an unredacted copy of any findings, notice, or report provided
by any Governmental Authority related to such inspection (to the extent related
to a Licensed Product) within [***] of Torii receiving the same, and (ii) a
written summary in English of any findings, notice, or report of a Governmental
Authority related to such inspection (to the extent related to a Licensed
Product) within [***] after receiving the same. Until the Regulatory
Responsibility Transfer Date, BioCryst will have the final decision-making
authority with respect to the content of any responses to Regulatory Authorities
or other Governmental Authorities that relate to a Licensed Product in the Field
in the Territory and will consider Torii’s reasonable comments to such
responses. After the Regulatory Responsibility Transfer Date, Torii will have
the final decision-making authority with respect to such responses to the extent
relating solely to the Commercialization of a Licensed Product in the Field in
the Territory and BioCryst will have the right to review and comment on any such
response. Other than with respect to Post-Marketing Activities, the costs and
expenses of any regulatory action for the Licensed Product in the Field in the
Territory will be borne by the Party that has the final decision-making
authority with respect to the same.

 

 

 

 

 

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

3.8Notice of Other Actions. In addition, each Party will promptly notify the
other of any information that it receives regarding any threatened or pending
action, inspection, or communication by or from a Third Party that would
reasonably be expected to materially affect the Development or Commercialization
of the Licensed Product in the Field in the Territory.

 

Article 4
DEVELOPMENT PROGRAM

 

4.1Development.

 

4.1.1General. Except for the Torii Regulatory Activities, which will be
conducted by or on behalf of Torii for the Licensed Product in the Field in the
Territory in accordance with Section 3.1 (Regulatory Responsibilities) and any
Torii Development Activities, BioCryst, at its sole cost and expense unless
otherwise agreed by the Parties, will have sole control over and decision-making
authority with respect to all Development activities for the Licensed Product
inside and outside of the Territory. Except for the Torii Regulatory Activities
and the Torii Development Activities, Torii will not perform any Development
activities for the Licensed Product. BioCryst will provide to Torii written
notice summarizing the content of any amendment to the protocol of (a) prior to
finalization thereof, the “Study to Evaluate the Efficacy and Safety of BCX7353
as an Oral Treatment for the Prevention of HAE Attacks in Japan (APeX-J)” and
(b) as promptly as practicable following finalization thereof, “Efficacy and
Safety Study of BCX7353 as an Oral Treatment for the Prevention of Attacks in
HAE (APeX-2).”

 

4.1.2Development Diligence. Subject to the terms of this Agreement, BioCryst
will use Commercially Reasonable Efforts to (a) conduct the Development of the
Licensed Product in accordance with the Current Phase III Protocols and (b)
perform any Additional Development pursuant to a written plan to be approved by
the JSC (in the event that Torii does not terminate the Agreement in accordance
with Section 13.2.1(a)) unless BioCryst reasonably determines, following
consultation with Torii, that there is a reasonable risk that the performance of
any Additional Development would have an adverse effect on the Licensed Product
outside the Territory or in the Territory outside of the Field. The obligations
set forth in this Section 4.1.2 (Development Diligence) will be BioCryst’s sole
and exclusive obligation to Develop the Licensed Product inside or outside of
the Territory. Without limitation, BioCryst will have no obligation to Develop
the Licensed Product in HAE-A or any Indication outside the Field.

 

4.1.3Additional Development. If (a) the PMDA or the MHLW requires any Additional
First Approval Development, or (b) either Party desires that BioCryst conduct
any Additional Essential Element Expansion Development or Additional Label
Expansion Development, then, in each case ((a) and (b)), the Parties will
discuss such activities at the JSC and Torii will have the right to elect, in
its sole discretion, by providing written notice to BioCryst no later than [***]
after Torii receives from BioCryst the estimated internal costs (at the FTE
Rate) and external expenses to be incurred by or on behalf of BioCryst in the
performance of such required Additional Development, to either: (i) terminate
this Agreement pursuant to Section 13.2.1(a), or (ii) to have BioCryst conduct
such activities in accordance with the terms of this Agreement and to reimburse
BioCryst for the applicable share of the Additional Development Costs set forth
in this Section 4.1.3 (Additional Development) such that Torii would reimburse
BioCryst for (A) [***] of all Additional First Approval Costs or Additional
Essential Element Expansion Cost and (B) [***] of all Additional Label Expansion
Costs, in each case ((A) and (B)), subject to Section 8.3.3(c) (Reductions for
Additional Development). If Torii does not provide such notice to BioCryst
within such [***] period, then Torii will be deemed to have elected to share the
applicable Additional Development Costs as set forth in this Section 4.1.3
(Additional Development) and Section 8.3.3(c) (Reductions for Additional
Development). If Torii elects (or is deemed to have elected) to share the
Additional Development Costs with BioCryst pursuant to the foregoing clause (b),
then BioCryst will invoice Torii for [***], and, in each case, Torii will pay
the undisputed invoiced amounts within [***] after the date of the invoice.
Torii may deduct from future Transfer Price Payments payable to BioCryst
pursuant to Section 8.3 (Transfer Price Payments to BioCryst) amounts reimbursed
to BioCryst as Additional Development Costs in accordance with Section 8.3.3(c)
(Reductions for Additional Development).

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

4.1.4Other Development. If Torii desires to perform any (a) Development
activities for the Licensed Product solely for purposes of Commercializing the
Licensed Product in the Field in the Territory or (b) Investigator Initiated
Clinical Development, then, in each case ((a) and (b)), Torii will present to
the JSC a proposal that outlines such activities and each Party’s
responsibilities for the conduct thereof and the costs associated therewith. The
JSC will review, discuss, and determine whether to approve the conduct of any
such Development activities, including each Party’s roles, responsibilities, and
financial obligations with respect to such further Development (any such
Development activities that the JSC determines will be conducted by Torii, the
“Torii Development Activities”).

 

Article 5
MANUFACTURING

 

5.1Supply by BioCryst.

 

5.1.1Commercial Supply. Promptly after the Effective Date the Parties will enter
into a commercial supply agreement (together with the corresponding quality
agreement, the “Supply Agreement”) for the supply to Torii of filled and
finished Licensed Product with all Approved Labeling for the Licensed Product in
the Field in the Territory, pursuant to which Torii will purchase exclusively
from BioCryst its requirements of the same as necessary for Torii to perform the
Torii Activities for the Licensed Product in the Field in the Territory. The
terms of the Supply Agreement will be consistent with the terms of this
Agreement and the terms of the supply agreements between BioCryst and its CMOs,
to the extent applicable to the supply of the Licensed Product for
Commercialization purposes in the Field in the Territory. BioCryst will supply
to Torii the Licensed Product for Commercialization purposes in the Field in the
Territory as provided in this Agreement (including Section 5.1.1 (Commercial
Supply)) and the Supply Agreement at no additional cost other than the
consideration received in the form of Transfer Price Payments with respect to
such Licensed Product in the Territory until the expiration of the Transfer
Price Payment Term for the Licensed Product. BioCryst shall cooperate with Torii
to facilitate Torii’s entry into a Quality Agreement with each manufacturer of
the Licensed Products or any component thereof to the extent required by the
Applicable Law.

 

-32-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

5.1.2BioCryst CMO Agreements. To the extent the terms of any agreement between
BioCryst and any CMO engaged to Manufacture the Compound or the Licensed
Products (or any component thereof) for Commercialization purposes in the Field
in the Territory are insufficient to (a) permit the supply of the Licensed
Product in the Field in the Territory in accordance with Applicable Law or (b)
comply with local market standards in the Territory applicable to
Commercialization, then BioCryst will amend such CMO agreements or make such
other arrangements, in each case, as necessary to reasonably address such
insufficiencies. In addition, BioCryst will include in each manufacturing or
supply agreement with any CMO engaged to Manufacture the Compound or the
Licensed Products (or any component thereof) for Commercialization purposes in
the Field in the Territory a provision that permits Torii to (i) at Torii’s
reasonable discretion, engage such CMO directly under BioCryst’s agreement with
such CMO or enter into its own agreement directly with such CMO on substantially
the same terms as BioCryst in case of a BioCryst Inability to Supply or Supply
Failure and (ii) be directly responsible to such CMO for all related obligations
under such agreement.

 

5.1.3Territory-Specific Packaging and Labeling. Upon Torii’s request at the
appropriate time prior to the Regulatory Responsibility Transfer Date, the JSC
will discuss in good faith and determine whether Torii will directly retain one
or more CMOs in the Territory to conduct Territory-Specific Packaging and
Labeling. If the JSC agrees that Torii may directly retain one or more CMOs that
BioCryst has engaged to conduct Territory-Specific Packaging and Labeling, then
BioCryst will make appropriate arrangements (including assignment to Torii of
the relevant agreements and any necessary transfer of BioCryst Manufacturing
Know-How necessary or reasonably useful to perform such packaging and labeling
activities).

 

5.1.4Shipment and Delivery. As between the Parties, BioCryst will be responsible
for obtaining all licenses or other authorizations for the exportation and
importation of all Licensed Product, and contract for shipment and insurance of
all Licensed Product from BioCryst’s or its CMO’s facility, at BioCryst’s cost
and expense. The Regulatory Responsible Party will also be responsible for the
quality control and quality assurance, release, and distribution of such
Licensed Product, at the Regulatory Responsible Party’s cost and expense.

 

5.2Product Tracking in the Territory. Torii will, and will ensure that its
Controlled Affiliates, Sublicensees, and Subcontractors, maintain adequate
records to permit the Parties to trace the distribution, sale, and use of all
Licensed Product in the Territory to the extent required by Applicable Law in
the Territory.

 

5.3Shortages. If a Party believes that there is a reasonable risk of shortage of
the Licensed Product for Commercialization purposes in the Field in the
Territory, then such Party will provide written notice to the other Party and
the Parties will discuss in good faith potential remedies or shortage mitigation
strategies. As will be more fully set forth in the Supply Agreement, as long as
BioCryst supplies to Torii the Licensed Product for use in the Territory, in the
event of a shortage of the Licensed Product for Commercialization purposes in
the Field in the Territory, BioCryst will (a) immediately investigate the
cause(s) of such shortage and report the result of such investigation to Torii,
(b) use Commercially Reasonable Efforts to remedy such shortage, and (c)
allocate available supply of the affected Licensed Product on a pro rata basis
between Torii on one hand and BioCryst and its other licensees on the other
hand, in each case, based on the demand for such Licensed Product in the
Territory as compared to demand for such Licensed Product outside of the
Territory.

 

-33-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

5.4Accreditation. BioCryst and Torii acknowledge that BioCryst and its
applicable Manufacturing sites for the Licensed Product for Commercialization
purposes in the Field in the Territory, including any test or storage
facilities, are required to be accredited under Applicable Law in the Territory.
To the extent required to obtain and maintain such accreditation, BioCryst will
require its CMOs to themselves apply to the applicable Regulatory Authority in
the Territory.

 

5.5Audits of Manufacturing Facilities.

 

5.5.1Audits of Manufacturing Facilities by Regulatory Authority.

 

(a)Prior to Regulatory Responsibility Transfer Date. If a Regulatory Authority
in the Territory requests an inspection or audit of the facilities of any CMO
engaged by BioCryst to Manufacture the Compound or Licensed Product (including
any test or storage facilities) for Commercialization purposes in the Field in
the Territory, then no later than [***] following such inspection or audit
BioCryst will provide to Torii a summary of issues noted by the applicable
Regulatory Authority during such inspection or audit.

  

(b)On or After Regulatory Responsibility Transfer Date. If a Regulatory
Authority in the Territory requests to Torii an inspection or audit of the
facilities of any CMO engaged by BioCryst to Manufacture the Compound or
Licensed Product (including any test or storage facilities) for
Commercialization purposes in the Field in the Territory, then Torii will
immediately notify BioCryst of such request, and BioCryst will, and will cause
the applicable CMO to, cooperate with Torii and the applicable Regulatory
Authority in fulfilling such request. Following receipt of the observations from
such an inspection or audit from such a Regulatory Authority (a copy of which
Torii will provide to BioCryst as soon as reasonably possible), BioCryst will,
and will cause the applicable CMO to, consult with Torii and prepare the
response to any such observations. Each Party will be responsible for its
internal costs and expenses associated with such an inspection or audit and as
between the Parties, Torii will bear (or reimburse Torii for, no later than
[***] after invoice therefor) the costs and expenses incurred by the applicable
CMO in connection with such inspection or audit. Nothing contained within this
Section 5.5.1 (Audits of Manufacturing Facilities by Regulatory Authority) will
restrict either Party from making a timely report to a Regulatory Authority or
take other action that it deems to be appropriate or required by Applicable Law.

  

5.5.2Audits of Manufacturing Facilities by Torii. At any time during the Term
(whether before or after the Regulatory Responsibility Transfer Date), but no
more than once per Calendar Year, upon reasonable advance notice during regular
business hours, BioCryst will permit Torii to perform GMP compliance audits at
CMOs engaged by BioCryst to Manufacture the Compound or Licensed Product
(including any test or storage facilities) for Commercialization purposes in the
Field in the Territory (including any test or storage facilities).

 

5.5.3Attendance to the Audits by BioCryst. BioCryst will perform periodic GMP
compliance audits of all CMOs engaged to Manufacture the Compound and the
Licensed Product for Commercialization purposes in the Territory in the Field in
accordance with BioCryst’s standard operating procedures. BioCryst will inform
Torii of the schedule of any such audits and will permit Torii to be present at
such audits.

 

-34-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

5.5.4Other Compliance Audits. Torii may perform a temporary GMP compliance audit
of the applicable CMOs engaged by BioCryst to Manufacture the Compound or the
Licensed Product for Commercialization purposes in the Field in the Territory in
the event of a (a) critical issue, as determined by Torii in its reasonable
discretion, or (b) material changes that are required on the Japanese Approved
Dossier for the Licensed Product in the Field in the Territory.

 

5.6Supply Failure.

 

5.6.1Notice. If a Party believes that there is a reasonable risk of a BioCryst
Inability to Supply or a Supply Failure, then such Party will provide written
notice to the other Party and the Parties will discuss in good faith potential
remedies or failure mitigation strategies.

 

5.6.2Investigation. In the event of any BioCryst Inability to Supply or Supply
Failure, BioCryst will immediately investigate the cause(s) of the applicable
BioCryst Inability to Supply or Supply Failure and report the results of such
investigation to Torii and the Parties will discuss in good faith potential
remedies or failure mitigation strategies. As will be more fully set forth in
the Supply Agreement, as long as BioCryst supplies to Torii the Licensed Product
for use in the Field in the Territory, in the event of a BioCryst Inability to
Supply or Supply Failure, BioCryst will use Commercially Reasonable Efforts to
remedy such event.

 

5.6.3No CMO Failure. In the event of a BioCryst Inability to Supply, solely
during the pendency of such BioCryst Inability to Supply, Torii may (a) engage
one or more CMOs previously engaged by BioCryst and place orders for the
Licensed Product directly from such CMOs, (b) provide to BioCryst reasonable
documentation of the actual amounts paid by Torii to such CMOs to Manufacture
the Licensed Product for Commercialization purposes in the Field in the
Territory, and (c) deduct from the Transfer Price Payments due to BioCryst under
this Agreement the actual amounts paid to such CMOs to Manufacture the Licensed
Product for Commercialization purposes in the Field in the Territory.

 

5.6.4CMO Failure; Technology Transfer. In the event of a Supply Failure, then
Torii may select and engage one or more Permitted Torii CMOs to Manufacture the
Licensed Product for Commercialization purposes in the Field in the Territory.
In such case, BioCryst will transfer to such Permitted Torii CMOs copies of the
BioCryst Manufacturing Know-How in electronic form or such other form maintained
by BioCryst, and the restrictions on Torii’s right to Manufacture the Compound
or the Licensed Product set forth in Section 2.1.3 (Covenant Not to Practice)
will terminate. To facilitate such transfer, upon Torii’s reasonable request,
BioCryst will make available to Torii or its selected Permitted Torii CMO a
reasonable number of BioCryst’s technical personnel with appropriate skill and
experience at times to be agreed by the Parties. Torii will be responsible for
all internal costs (at the FTE Rate) and external expenses incurred by BioCryst
in connection with such transfer of Know-How if such transfer is required solely
for supply of the Compound or the Licensed Product for Commercialization
purposes in the Field in the Territory. Accordingly, BioCryst may invoice Torii
for such costs and expenses, and Torii will pay the undisputed invoiced amounts
within [***] after the date of the invoice. In the event that Torii performs any
Torii Manufacturing Activities as a result of such a failure of one or more CMOs
engaged by BioCryst to Manufacture the Compound or the Licensed Product for
Commercialization purposes in the Field in the Territory, Torii may deduct from
the Transfer Price Payments due to BioCryst under this Agreement the actual,
documented amounts paid by Torii to any Permitted Torii CMO for Licensed Product
Manufactured by or on behalf of Torii.

 

-35-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

Article 6
COMMERCIALIZATION

 

6.1Commercialization Responsibilities. Subject to oversight of the JSC and the
other terms of this Agreement, Torii, at its sole cost and expense, will have
sole control over and decision-making authority with respect to all
Commercialization activities for the Licensed Product in the Field in the
Territory. Torii will conduct all Commercialization of each Licensed Product in
the Field in the Territory in accordance with the Commercialization Plan for
such Licensed Product and subject to the terms of this Agreement and any other
written agreement between the Parties with respect to the subject matter set
forth herein.

 

6.2Commercialization Diligence. Torii will use Commercially Reasonable Efforts
to (a) Commercialize the Licensed Product in the Field in the Territory and (b)
meet the Performance Targets by the applicable date for the achievement thereof
set forth in the Commercialization Plan.

 

6.3Commercialization Plans. No later than [***] after the submission of the
first MAA for the Licensed Product in the Field in the Territory, Torii will
develop, review, and discuss an initial draft of the written plan for
Commercialization of the Licensed Product in the Field in the Territory (each,
as updated from time to time in accordance with this Section 6.3
(Commercialization Plans) and Section 7.2 (Joint Steering Committee), a
“Commercialization Plan”) and provide such initial draft to the JSC to review,
discuss, and determine whether to approve. The Commercialization Plan for the
Licensed Product in the Field in the Territory will include for such Licensed
Product in the Field in the Territory, among other material commercial matters,
(a) pre-launch, launch, and subsequent Commercialization strategies and
activities (which may include, as appropriate at any given time based on the
stage of Commercialization, market access strategy, messaging, branding,
advertising, education, publication planning, public relations programs,
marketing, and field force training), and (b) key performance indicators for the
then-current Launch Year, which key performance indicators will include:

 

6.3.1[***];

 

6.3.2[***]; and

 

6.3.3[***].

 

Each Commercialization Plan for a Licensed Product (including each update
thereto) must include all Commercialization activities to be performed by or on
behalf of Torii with respect to the Licensed Product in the Field in the
Territory and must be consistent with BioCryst’s global brand strategy and
global key positioning and messaging for such Licensed Product (each, a “Global
Brand Strategy”), the then-current version of which BioCryst will provide to
Torii no later than [***] after the Effective Date and thereafter from time to
time in the event of a material change thereto.

 

6.4Coordination of Commercialization Activities. The Parties recognize that each
Party may benefit from the coordination of certain Commercialization activities
for the Licensed Product inside and outside of the Territory (other than pricing
for the Licensed Product inside and outside of the Territory, the
responsibilities for which are set forth in Section  6.5 (Pricing)).
Accordingly, the Parties will coordinate such activities through the JSC where
appropriate, which coordination may include communications regarding product
positioning.

 

-36-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

6.5Pricing.

 

6.5.1Reimbursement Approvals. The Regulatory Responsible Party, itself or
through its designee, will have the right to seek Reimbursement Approval and
obtain the Adjusted NHI Price of the Licensed Product sold in the Field in the
Territory, and the other Party will not have the right to direct, control, or
approve the Adjusted NHI Price of the Licensed Product sold in the Field in the
Territory. BioCryst, itself or through its designee, will have the right to seek
Reimbursement Approval and to determine the price of the Licensed Product sold
outside of the Territory and in the Territory outside of the Field, including
all discount and rebate strategies and other economic arrangements relating to
the Licensed Product outside of the Territory and in the Territory outside of
the Field, and Torii will not have the right to direct, control, or approve the
price of the Licensed Product sold outside of the Territory or in the Territory
outside of the Field. The other Party will provide reasonably requested
assistance in connection with obtaining Reimbursement Approval for the Licensed
Product in the Field in the Territory, including, if required by Applicable Law,
to submit any application for Reimbursement Approval or other Regulatory
Submission in such Party’s name as reasonably requested by the Regulatory
Responsible Party. The Regulatory Responsible Party will keep the other Party
timely informed on the status of any application for Reimbursement Approval for
the Licensed Product in the Field in the Territory, including any discussion
with any Regulatory Authority or other Governmental Authority with respect
thereto.

 

6.5.2Pricing (Not Relating to Reimbursement Approvals). Notwithstanding Section
6.5.1 (Reimbursement Approvals), Torii will have the right to determine the
price of the Licensed Product for sale in the Field in the Territory, including
all discount and rebate strategies and other economic arrangements relating to
the Licensed Product in the Field in the Territory, and BioCryst will not have
the right to direct, control, or approve the price of the Licensed Product sold
in the Field in the Territory.

 

6.6Diversion. Torii will not, and will reasonably ensure that its Affiliates and
Sublicensees and Subcontractors do not, either directly or indirectly, promote,
market, distribute, import, sell, or have sold any Licensed Product to any Third
Party or to any address or Internet Protocol address or the like outside of the
Territory or in the Territory outside of the Field, including via the Internet
or mail order. Notwithstanding any provision to the contrary set forth in this
Agreement, BioCryst will have the right to attend, or have its designees attend,
conferences and meetings of congresses inside and outside of the Territory and
to promote and market the Licensed Product in the Territory to Third Party
attendees at such conferences and meetings, subject to this Section 6.6
(Diversion). Torii will have the right to attend, or have its designees attend,
conferences and meetings of congresses outside of the Territory hosted or
sponsored by BioCryst. As applicable, (a) in the case of Torii, in any country
or jurisdiction outside of the Territory or in the Territory outside of the
Field, and (b) in the case of BioCryst, in the Field in the Territory:

 

6.6.1such Party will not engage, nor permit its Affiliates or Sublicensees to
engage, in any advertising or promotional activities relating to the Licensed
Product for use directed primarily to customers or other buyers or users of the
Licensed Product located in any such country or jurisdiction;

 

-37-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

6.6.2such Party will not solicit orders from any prospective purchaser located
in any such country or jurisdiction;

 

6.6.3such Party will not, and will cause its Affiliates and Sublicensees to not,
deliver or tender (or cause to be delivered or tendered) any Licensed Product to
Third Parties for use in such country or jurisdiction; and

 

6.6.4if either Party or its Affiliates or Sublicensees receive any order for any
Licensed Product from a prospective purchaser located in any such country or
jurisdiction, then such Party will immediately refer that order to the other
Party or its designee and will not accept any such orders.

 

6.7Extraordinary Circumstances. In the event of one or more Serious Adverse
Events related to the Licensed Product in the Field in the Territory, material
changes in the regulatory or pricing framework with respect to the Licensed
Product in the Field in the Territory or any other extraordinary circumstances
that would have a material negative impact on the Commercialization of the
Licensed Product in the Field in the Territory, promptly following Torii’s
reasonable request, the Parties will discuss in good faith any amendments that
should be made to this Agreement (or whether to terminate this Agreement) as a
result of such circumstances. No changes to this Agreement will be made (and no
termination effective) unless agreed in writing by duly authorized
representatives of each Party in accordance with Section 15.9 (Entire Agreement;
Amendments).

 

6.8Advertising and Promotional Materials. Reasonably promptly after the
Effective Date and thereafter on a regular basis from time to time, BioCryst
will provide to Torii those Promotional Materials developed by BioCryst to be
adapted by Torii for use in the Field in the Territory. Torii will develop all
Promotional Materials, which will be consistent with the Global Brand Strategy
and compliant with Applicable Laws, the terms of all applicable Regulatory
Approvals, the applicable guidelines from the Japan Pharmaceutical Manufacturers
Association and Torii’s internal medical compliance policy. Reasonably in
advance of the use thereof by Torii of any new key messages in any Promotional
Materials not previously approved by BioCryst, Torii will provide BioCryst with
such proposed key messages. BioCryst will have the right to review, comment on,
and approve all such key messages prior to the first use thereof, which comments
or approval or failure to approve, in each case, BioCryst must communicate to
Torii no later than [***] after BioCryst’s receipt thereof. If BioCryst does not
communicate its comments, approval, or non-approval on such key messages within
the above [***] period, then BioCryst will be deemed to have approved the use of
such new key messages. In addition, at least annually thereafter (or more
frequently if reasonably requested by BioCryst), Torii will submit to the JSC
representative samples of the Promotional Materials developed by or on behalf of
Torii for use in the Field in the Territory. In addition to BioCryst’s right to
approve all new key messages to be used in any Promotional Materials, Torii will
incorporate any changes to Promotional Materials requested by BioCryst in a
timely fashion that BioCryst believes in good faith are necessary to enable
BioCryst to comply with any Applicable Law and Torii will consider in good faith
any other timely comments that BioCryst (through the JSC) may have with respect
to any such Promotional Materials. Copies of all Promotional Materials used by
Torii in the Territory will be archived by Torii in accordance with Applicable
Law in the Territory.

 

6.9Product Trademarks.

 

6.9.1Global Brand Elements. Torii acknowledges that BioCryst may decide to
develop and adopt certain distinctive colors, logos, images, symbols, and
trademarks to be used in connection with the Commercialization of the Licensed
Product on a global basis (such branding elements, collectively, the “Global
Brand Elements”). BioCryst will and hereby does grant Torii the exclusive right
to use such Global Brand Elements in connection with the Commercialization of
the Licensed Product in the Field in the Territory.

 

-38-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

6.9.2Product Marks in the Field in the Territory. Subject to the terms and
conditions of this Agreement, BioCryst will and hereby does grant Torii the
exclusive right (even as to BioCryst and its Affiliates) to use such Product
Marks in connection with the Commercialization of the Licensed Product in the
Field in the Territory. Subject to this Section 6.9.2 (Product Marks in the
Field in the Territory), BioCryst will have the right to determine the branding
for the Licensed Product in the Field in the Territory using those trademarks,
logos, and trade names that it determines appropriate for such Licensed Product
and that are consistent with BioCryst’s Global Brand Elements (the “Product
Marks”); provided, however, to the extent possible, the Product Marks will be
the same as the colors, logos, images, symbols, and trademarks used for
Commercialization of the Licensed Product worldwide, inside and outside of the
Field. In advance of selecting the Product Marks, BioCryst will conduct a
trademark clearance search for the Territory at BioCryst’s cost and expense.
BioCryst will provide Torii (through the JSC) with a reasonable opportunity to
review and provide comments on each proposed Product Mark, and BioCryst will
consider in good faith and incorporate where appropriate (in BioCryst’s
reasonable discretion) Torii’s comments before selecting the Product Marks
(including those related to the use of fonts in the Japanese language and for
consistency with Torii’s corporate color and package designs in its other
products). Torii will not use any trademarks of BioCryst (including BioCryst’s
corporate name) or any trademark confusingly similar thereto, except as
expressly permitted under this Agreement or otherwise, without BioCryst’s prior
written consent.

 

6.9.3Ownership. BioCryst will be the sole and exclusive owner of all Product
Marks and Global Brand Elements, including all trademark registrations and
applications therefor and all goodwill associated therewith. To the extent Torii
acquires any rights, title, or interests in or to any Product Mark or Global
Brand Element (including any trademark registration or application therefore or
goodwill associated with any Product Mark), Torii will, and hereby does, assign
the same to BioCryst. BioCryst will register and maintain the Product Marks in
the Territory that it determines reasonably necessary in BioCryst’s name, and
will be responsible for all filing, prosecution, and defense before all
trademark offices in the Territory of the Product Marks. Torii will be
responsible for [***] of all registration and renewal official fees incurred
with respect to the Product Marks in the Field in the Territory and BioCryst
will bear all other costs associated with the registration, renewal, filing,
prosecution, and defense of the Product Marks in the Field in the Territory.
Accordingly, BioCryst will invoice Torii for the foregoing costs and expenses
associated with the performance of such registration and maintenance of the
Product Marks as set forth under this Section 6.9.3 (Ownership), and Torii will
pay the undisputed invoiced amounts within [***] after the date of the invoice.
In determining registration and maintenance of the Product Marks in the
Territory, BioCryst will take into consideration, among others, that trademark
rights do not derive from trademark use, but only from registration under the
Japanese Trademark Act.

 

6.9.4Torii’s Right for Trademarks. Notwithstanding Section 6.9.3 (Ownership), if
Torii notifies all of BioCryst’s JSC members that it requests BioCryst to apply
for a Product Mark that is used or intended to be used in the Field in the
Territory, and BioCryst (a) notifies Torii of BioCryst’s decision not to apply
for registration of such Product Mark in the Field in the Territory in
BioCryst’s name or (b) agrees in writing that Torii may apply for registration
for such Product Mark in the Field in the Territory, in each case ((a) and (b)),
no later than [***] after receipt of such request by BioCryst, then Torii may,
at its sole cost and expense, apply for, own, and maintain the registration in
the Territory, if granted, for such Product Mark. If BioCryst fails to respond
to any notice provided by Torii pursuant to this Section 6.9.4 (Torii’s Rights
to Trademarks) [***] following the JSC’s receipt thereof, then BioCryst will be
deemed to have approved Torii’s application for and ownership of such Product
Mark.

 

-39-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

6.9.5Tsujo Shiyoken and Senyo Shiyoken. Prior to the Regulatory Responsibility
Transfer Date, BioCryst will reasonably support Torii in obtaining registration
under the name of Torii in the Territory of the license granted to Torii under
this Agreement to Commercialize the Licensed Product in the Field in the
Territory as a “Tsujo Shiyoken” in accordance with Article 31 of the Japanese
Trademark Act, which registration will not preclude BioCryst from exercising its
rights or performing its obligations under this Agreement. Promptly following
the Regulatory Responsibility Transfer Date, BioCryst will reasonably support
Torii in obtaining registration under the name of Torii in the Territory of the
exclusive license granted to Torii under this Agreement to Commercialize the
Licensed Product in the Field in the Territory as a “Senyo Shiyoken” in
accordance with Article 30 of the Japanese Trademark Act.

 

6.9.6Use. Torii agrees that it and its Affiliates and Sublicensees will
Commercialize each Licensed Product in the Field in the Territory in a manner
consistent with the Global Brand Elements and will: (a) ensure that all Licensed
Product that is sold bearing the Product Marks and Global Brand Elements are of
a high quality consistent with industry standards for global pharmaceutical and
biologic therapeutic products; (b) ensure that each use of the Global Brand
Elements and Product Marks by or on behalf of Torii and its Affiliates and
Sublicensees is accompanied by an acknowledgement that such Global Brand
Elements and Product Marks are owned by BioCryst; (c) not use such Global Brand
Elements or Product Marks in a way that might prejudice their distinctiveness or
validity or the goodwill of BioCryst therein and includes the trademark
registration symbol ® or ™ as appropriate; (d) not use any trademarks or trade
names so resembling any of such Global Brand Elements or Product Marks as to be
likely to cause confusion or deception; and (e) place and display the Global
Brand Elements and the Product Marks on and in connection with the Licensed
Product in a way that acknowledges BioCryst’s role in discovering the Licensed
Product and that such Licensed Product is under license from BioCryst. To the
extent permitted by Applicable Law and consistent with local industry standard,
Torii will include the words “Developed by BioCryst” in relevant scientific,
medical, and other Licensed Product-related communications, or such other
similar or otherwise customary text provided by Torii and reasonably acceptable
to BioCryst.

 

Article 7
GOVERNANCE

 

7.1Alliance Managers. Each Party will appoint an individual to act as its
alliance manager under this Agreement as soon as practicable after the Effective
Date (each an “Alliance Manager”). The Alliance Managers will: (a) serve as the
primary points of contact between the Parties for the purpose of providing the
other Party with information on the progress of a Party’s activities under this
Agreement; (b) be responsible for facilitating the flow of information and
otherwise promoting communication, coordination, and collaboration between the
Parties; (c) facilitate the prompt resolution of any disputes; and (d) attend
JSC meetings, in each case, as a non-voting member. An Alliance Manager may also
bring any matter to the attention of the JSC if such Alliance Manager reasonably
believes that such matter warrants such attention. Each Party will use
reasonable efforts to keep an appropriate level of continuity but may replace
its Alliance Manager at any time upon written notice to the other Party.

 

-40-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

7.2Joint Steering Committee.

 

7.2.1Formation and Purpose of JSC. No later than [***] after the Effective Date,
the Parties will establish a joint steering committee (the “JSC”) to monitor and
coordinate the Development and Commercialization of the Licensed Product in the
Field in the Territory. The JSC will be composed of an equal number of
representatives from each Party and a minimum of three (3) representatives of
each Party and who have the appropriate and direct knowledge and expertise and
requisite decision-making authority. Each Party may replace any of its
representatives on the JSC and appoint a person to fill the vacancy arising from
each such replacement. A Party that replaces a representative will notify the
other Party at least [***] prior to the next scheduled meeting of the JSC. Both
Parties will use reasonable efforts to keep an appropriate level of continuity
in representation. Representatives may be represented at any meeting by another
person designated by the absent representative. BioCryst will designate one of
its JSC representatives as one of the co-chairpersons of the JSC and Torii will
designate one of its members as the other co-chairperson of the JSC. Each
Party’s representatives on the JSC will inform and coordinate within their
respective organization to enable each Party to fulfill its obligations as
agreed upon between the Parties under this Agreement, including within the
timeframes set forth hereunder.

 

7.2.2JSC Roles and Responsibilities. The responsibilities of the JSC will be to:

 

(a)provide a forum for the discussion of the Parties’ activities under this
Agreement;

 

(b)review and discuss the Development and Manufacturing of the Licensed Product
both inside and outside of the Territory for Commercialization purposes in the
Field in the Territory (including any material changes to the Current Phase III
Protocols), and Commercialization of the Licensed Product in the Field in the
Territory;

 

(c)review and discuss the protocol for the Post-Marketing Activities, and
review, discuss, and determine whether to approve the Post-Marketing Budget and
any update thereto or overrun thereof, in each case, as described in Section
3.1.2 (Post-Marketing Activities);

 

(d)review, discuss, and determine whether to approve the plan for the
performance of any Additional Development to be performed in the event that
Torii does not terminate the Agreement in accordance with Section 13.2.1(a), as
described in Section 4.1.3 (Additional Development);

 

(e)review, discuss, and determine whether to approve the conduct of (i) any
Development activities for the Licensed Product proposed by Torii for purposes
of Commercializing the Licensed Product in the Field in the Territory or (ii)
any Investigator Initiated Clinical Development, and determine whether to
allocate to Torii responsibility for any Torii Development Activities, in each
case, as described in Section 4.1.4 (Other Development);

 

(f)oversee the implementation of, and the coordination between the Parties of
activities to be performed under, the Supply Agreement, the SDE Agreements, and
any other written agreement between the Parties with respect to the Licensed
Product in the Field in the Territory;

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

(g)review and discuss a detailed timeline for the transfer of the Assigned
Regulatory Materials and each Party’s roles and responsibilities therefor, as
described in Section 3.4 (Transfer of Regulatory Materials);

 

(h)discuss and determine whether Torii will perform any Territory-Specific
Packaging and Labeling, as described in Section 5.1.3 (Territory-Specific
Packaging and Labeling);

 

(i)review, discuss, and determine whether to approve the Commercialization Plan
(including the Performance Targets set forth therein) and any updates thereto,
as described in Section 6.3 (Commercialization Plans);

 

(j)review and discuss any request by Torii that BioCryst apply for a Product
Mark that is used or intended be used in the Field in the Territory, as
described in Section 6.9.4 (Torii’s Rights for Trademarks);

 

(k)review, discuss, and determine matters in the Territory that may have a
material adverse impact upon the regulatory status of the Licensed Product
outside the Territory as provided in Section 7.6 (No Harmful Actions);

 

(l)review, discuss, and determine the Publication and Communication Strategy and
any updates thereto for the Licensed Product, as described in Section 9.6
(Publications);

 

(m)review, discuss, and determine the FTE Rate and any update thereto prior to
the commencement of any relevant activities under this Agreement that require
reimbursement at the FTE Rate;

 

(n)serve as a forum to receive updates on market access, reimbursement, and
pricing strategy for the Licensed Product in the Field in the Territory;

 

(o)establish and dissolve any subcommittee or working group to discuss specific
matters under this Agreement; and

 

(p)perform such other functions as expressly set forth in this Agreement or
allocated to the JSC by the Parties’ written agreement.

 

7.2.3Meeting Agendas. Each Party will disclose to the other Party the proposed
agenda items along with appropriate information at least [***] in advance of
each meeting of the JSC; provided that under exigent circumstances requiring JSC
input, a Party may provide its agenda items to the other Party within a shorter
period of time in advance of a meeting, or may propose that there not be a
specific agenda for a particular meeting, so long as such other Party consents
to such later addition of such agenda items or the absence of a specific agenda
for such JSC meeting.

 

7.2.4Meetings. The JSC will hold meetings at such times as it elects to do so,
but will meet no less frequently than quarterly until the first anniversary of
the First Commercial Sale of the Licensed Product in the Field in the Territory,
and semi-annually thereafter, unless otherwise agreed by the Parties. All
meetings will be conducted in English unless otherwise agreed by the Parties.
The JSC may meet in person or by means of teleconference, Internet conference,
videoconference, or other similar communication method; provided that at least
one meeting each Calendar Year will be conducted in person at a location
selected alternatively by BioCryst and Torii or such other location as the
Parties may agree. Each Party will be responsible for all of its own costs and
expenses of participating in any JSC meeting. BioCryst’s Alliance Manager will
prepare and circulate minutes for each JSC meeting within [***] after each such
meeting and each Party’s Alliance Manager will ensure that such minutes are
reviewed and approved by their respective companies within [***] thereafter.

 

-42-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

7.3Non-Member Attendance. Each Party may from time to time invite a reasonable
number of participants, in addition to its representatives (which may include
legal counsel), to attend a meeting of the JSC (in a non-voting capacity), if
such participants have expertise that is relevant to the planned agenda for such
JSC meeting; provided that if either Party intends to have any Third Party
(including any consultant) attend such a meeting, then such Party will provide
prior written notice to the other Party reasonably in advance of such meeting
and will ensure that such Third Party is bound by obligations of confidentiality
and non-use at least as stringent as those set forth in Article 9
(Confidentiality; Publication). Notwithstanding any provision to the contrary
set forth in this Agreement, if the other Party objects in good faith to the
participation of such Third Party in such meeting due to a bona fide concern
regarding competitively sensitive information that is reasonably likely to be
discussed at such meeting (i.e., a consultant that also provides services to a
Third Party with a Competitive Product), then such Third Party will not be
permitted to participate in such meeting (or the portion thereof during which
such competitively sensitive information is reasonably likely to be discussed).

 

7.4Decision-Making.

 

7.4.1General Process. The JSC will only have the powers expressly assigned to it
in this Article 7 (Governance) and elsewhere in this Agreement and will not have
the authority to: (a) modify or amend the terms of this Agreement; or (b) waive
either Party’s compliance with the terms of this Agreement. All decisions of the
JSC will be made by unanimous vote, with each Party’s representatives having one
vote (i.e., one vote per Party). No action taken at any meeting of the JSC will
be effective unless there is a quorum at such meeting, and at all such meetings,
a quorum will be reached if two voting representatives of each Party are present
or participating in such meeting. Except as otherwise expressly set forth in
this Agreement, the phrase “determine,” “designate,” “confirm,” “approve,” or
“determine whether to approve” by the JSC and similar phrases used in this
Agreement will mean approval in accordance with this Section 7.4
(Decision-Making), including the escalation and tie-breaking provisions herein.
For the avoidance of doubt, matters that are specified in Section 7.2.2 (JSC
Roles and Responsibilities) to be reviewed and discussed (as opposed to
reviewed, discussed, and determined) do not require any agreement or decision by
either Party and are not subject to the voting and decision-making procedures
set forth in this Section 7.4 (Decision-Making) or in Section 7.5 (Resolution of
JSC Disputes).

 

7.4.2Decisions of the JSC. The JSC will use good faith efforts, in compliance
with this Section 7.4.2 (Decisions of the JSC), to promptly resolve any such
matter for which it has authority. If, after the use of good faith efforts, the
JSC is unable to resolve any matter that is within the scope of the JSC’s
authority or any other disagreement between the Parties that may be referred to
the JSC, in each case, within a period of [***] after the applicable meeting of
the JSC at which the JSC is unable to reach a resolution, then a Party may refer
such matter for resolution in accordance with Section 7.5.1 (Referral to
Executive Officers) to the Chief Executive Officer of BioCryst (or an executive
officer of BioCryst designated by the Chief Executive Officer of BioCryst who
has the power and authority to resolve such matter) and the Chief Executive
Officer of Torii (or an executive officer of Torii designated by the Chief
Executive Officer of Torii who has the power and authority to resolve such
matter) (collectively, the “Executive Officers”).

 

-43-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

7.5Resolution of JSC Disputes.

 

7.5.1Referral to Executive Officers. If a Party makes an election under
Section 7.4.2 (Decisions of the JSC) to refer a matter on which the JSC cannot
reach a consensus decision for resolution by the Executive Officers, which
election must be made no later than [***] after the applicable meeting of the
JSC at which the JSC is unable to reach a consensus decision, then the Parties
will each submit in writing the respective positions of the Parties to the
Executive Officers. The Executive Officers will use good faith efforts to
resolve any such matter so referred to them as soon as practicable, and any
final decision that the Executive Officers agree to in writing will be
conclusive and binding on the Parties.

 

7.5.2Final Decision-Making Authority. If the Executive Officers are unable to
reach agreement on any such matter referred to them within ten (10) Business
Days after such matter is so referred (or such longer period as the Executive
Officers may agree upon), then:

 

(a)No Change; Status Quo. [***].

 

(b)Decision-Making before the Regulatory Responsibility Transfer Date. Other
than the matters set forth in Section 7.5.2(a) (No Change; Status Quo):

 

(i)BioCryst Decisions. [***].

 

(ii)Torii Decisions. [***].

 

(c)Decision-Making after the Regulatory Responsibility Transfer Date. Other than
the matters set forth in Section 7.5.2(a) (No Change; Status Quo):

 

(i)Torii Decisions. [***].

 

(ii)BioCryst Decisions. [***].

 

 

7.5.3Limitations on Decision-Making. Notwithstanding any provision to the
contrary set forth in this Agreement, without the other Party’s prior written
consent, no decision of the JSC or a Party’s Executive Officer (in the exercise
of a Party’s final decision-making authority on any such matters), in each case,
may (a) result in a material increase in the other Party’s obligations, costs,
or expenses under this Agreement, unless, in each case, such actions are
reasonably necessary for each Party to comply with Applicable Law as the
Territory Sponsor or as the owner and holder of any Regulatory Submission,
Regulatory Approval, or Reimbursement Approval, as applicable, for the Licensed
Product, (b) take or decline to take any action that would be reasonably likely
to result in a violation of any Applicable Law, the requirements of any
Regulatory Authority, or any agreement with any Third Party (including any
agreement pursuant to which BioCryst Controls any BioCryst Technology) or would
be reasonably likely to result in the infringement or misappropriation of
intellectual property rights of any Third Party, or (c) conflict with this
Agreement, any Supply Agreement, any SDE Agreement, or any other agreement
between the Parties related to the subject matter set forth herein.

 

-44-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

7.6No Harmful Actions. If, following the Regulatory Responsibility Transfer
Date, BioCryst believes that Torii is taking or intends to take any action with
respect to the Licensed Product that could have a material adverse impact upon
the regulatory status of the Licensed Product outside of the Territory or in the
Territory or the global pricing of the Licensed Product, then, in each case,
BioCryst may bring the matter to the attention of the JSC and the JSC will
discuss in good faith a resolution to such concern. Without limiting the
foregoing, unless the Parties otherwise agree (or unless otherwise set forth in
this Agreement), Torii will not communicate with any Regulatory Authority or
other Governmental Authority having jurisdiction outside of the Territory with
respect to the Licensed Product outside of the Territory or in the Territory
outside of the Field, unless so ordered by such Regulatory Authority or other
Governmental Authority, in which case, Torii will immediately notify BioCryst of
such order.

 

Article 8
PAYMENTS

 

8.1Upfront Payment. As consideration for the rights and licenses granted by
BioCryst to Torii under this Agreement, within [***] after the later of (a) the
Effective Date and (b) receipt from BioCryst of all completed tax documents to
file with tax authorities in Japan in order to reduce BioCryst’s tax liability
(“Tax Documents”), Torii will pay to BioCryst, by wire transfer of immediately
available funds, a one-time, non-refundable, non-creditable upfront payment of
Twenty-Two Million United States Dollars ($22,000,000) (the “Upfront Payment”).

 

8.2Milestone Payments.

 

8.2.1Milestone Events and Payments. No later than [***] after the later of (a)
achievement of the regulatory milestone event for the Licensed Product set forth
below and (b) receipt from BioCryst of the Tax Documents, Torii will pay to
BioCryst the corresponding regulatory milestone payment as set forth below (the
regulatory milestone event set forth in Table 8.2.1, the “Milestone Event,” and
the regulatory milestone payment set forth in Table 8.2.1, the “Milestone
Payment”). Notwithstanding anything to the contrary in this Section 8.2.1
(Milestone Events and Payments), if (i) the Adjusted NHI Price upon receipt of
Regulatory Approval and Reimbursement Approval from the MHLW for the Licensed
Product in HAE-P in the Territory is less than [***] or (ii) either of
Regulatory Approval or Reimbursement Approval for the Licensed Product in HAE-P
in the Territory has not been obtained by December 31, 2021, then no Milestone
Payment will be due to BioCryst upon the achievement of such Milestone Events.

 

Table 8.2.1 – REGULATORY MILESTONES Milestone Event Milestone Payment (in U.S.
Dollars) – If the first Regulatory Approval for the Licensed Product in the
Territory is received on or prior to December 31, 2020 Milestone Payment (in
U.S. Dollars) – If the first Regulatory Approval for the Licensed Product in the
Territory is received between January 1, 2021 and December 31, 2021 Receipt of
Regulatory Approval and Reimbursement Approval from the MHLW for the first
Licensed Product in HAE-P in the Territory, solely if the Adjusted NHI Price is
equal to or greater than [***]

$20,000,000

 

 

 

$15,000,000                    

 

-45-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

8.3Transfer Price Payments to BioCryst.

 

8.3.1Transfer Price Rates. Subject to the remainder of this Section 8.3
(Transfer Price Payments to BioCryst), Torii will make payments to BioCryst for
each Licensed Product sold in the Territory, calculated by multiplying the
applicable transfer price rate set forth below in either Column (A) or Column
(B) of Table 8.3.1 (as applicable) by the aggregate amount of Net Sales of such
Licensed Product sold in the Territory in the applicable Calendar Quarter. The
transfer price payments due with respect to Net Sales of each Licensed Product
pursuant to this Section 8.3 (Transfer Price Payments to BioCryst), collectively
the “Transfer Price Payments.”

 

Table 8.3.1 – LICENSED PRODUCT TRANSFER PRICE PAYMENTS

Portion of Aggregate Annual Net Sales of Licensed Product in the Territory

(in Japanese Yen)

Column (A)

Transfer Price Rate – If SAKIGAKE Designation is not cancelled before receipt of
the first Regulatory Approval for the Licensed Product in the Territory

Column (B)

Transfer Price Rate – If SAKIGAKE Designation is cancelled before receipt of the
first Regulatory Approval for the Licensed Product in the Territory

For the portion of annual Net Sales of Licensed Product in the Territory up to
[***] 20% 15% For the portion of annual Net Sales of Licensed Product in the
Territory exceeding [***] and up to [***] 30% 25% For the portion of annual Net
Sales of Licensed Product in the Territory exceeding [***] 40% 35%

 

For example, if there is [***] in aggregate annual Net Sales of the Licensed
Product in the Territory in a given Calendar Year and SAKIGAKE Designation is
not cancelled before receipt of approval of the MAA by the MHLW with respect to
such Licensed Product, then Torii would owe quarterly Transfer Price Payments
aggregating ([***] x 20%) + ([***] x 30%) = [***], which would be payable on a
Calendar Quarterly basis as Net Sales are accrued. For example, in such scenario
if such [***] were accrued in equal amounts over the course of four Calendar
Quarters in a year, then the payments would be as follows: first Calendar
Quarter: [***] x 20%, second Calendar Quarter: [***] x 20%, third Calendar
Quarter: ([***] x 20%) + ([***] x 30%), fourth Calendar Quarter: [***] x 30%.

 

8.3.2Transfer Price Payment Term. Torii will pay to BioCryst the Transfer Price
Payments on a Licensed Product-by-Licensed Product basis in the Territory
beginning on the date of the First Commercial Sale of such Licensed Product
until the later of: (a) the tenth (10th) anniversary of the date of the First
Commercial Sale of such Licensed Product in the Territory; and (b) the
expiration of the last Valid Claim within the Transfer Price Patent Rights that
Covers the composition of matter, or method of use in the Approved Labeling of
such Licensed Product in the Field in the Territory; and (c) the expiration of
Regulatory Exclusivity for such Licensed Product in the Field in the Territory
(“Transfer Price Payment Term”), provided, however, that Transfer Price Payment
Term will expire with respect to a particular Licensed Product in the Territory
if (i) during the period following the tenth (10th) anniversary of the date of
the First Commercial Sale of such Licensed Product in the Territory and, if
later, the expiration of Regulatory Exclusivity for such Licensed Product in the
Field in the Territory, there is no other Valid Claim other than a pending
application within the Transfer Price Patent Rights that Covers the composition
of matter or method of use in the Approved Labeling of the Licensed Product in
the Field in the Territory, and (ii) there is a Loss of Market Exclusivity for
such Licensed Product in the Territory. On a Licensed Product-by-Licensed
Product basis, upon the expiration of the Transfer Price Payment Term, the
license granted to Torii under Section 2.1 (License Grants to Torii) will become
non-exclusive, fully paid-up, perpetual and irrevocable with respect to such
Licensed Product, so long as at such time Torii has paid to BioCryst all amounts
due under this Agreement in accordance with the terms hereof and is not at such
time in breach of this Agreement. A Licensed Product will be considered a
separate Licensed Product with a distinct Transfer Price Payment Term if a new
MAA (and not a supplemental MAA) is required to be submitted in order to receive
Regulatory Approval for such Licensed Product in the Field in the Territory, and
notwithstanding any provision to the contrary set forth in this Agreement, the
Licensed Product for HAE-P will be a separate Licensed Product from the Licensed
Product for HAE-A.

 

-46-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

8.3.3Transfer Price Reductions.

 

(a)Generic Product Reduction. Subject to Section 8.3.3(e) (Cumulative Reductions
Floor), on a Licensed Product-by-Licensed Product basis, if during any Calendar
Quarter, there is Loss of Market Exclusivity for such Licensed Product in the
Territory, then the transfer price rate applicable to Net Sales of such Licensed
Product in the Territory in such Calendar Quarter will be reduced by [***] of
the applicable transfer price rate that would otherwise be owed on such Net
Sales of such Licensed Product in the Territory under Section 8.3 (Transfer
Price Rates). Torii will promptly notify BioCryst of the occurrence of Loss of
Market Exclusivity, which notice will specify the applicable Generic Products
and Indication.

 

(b)Third Party Patent Rights and Know-How. Subject to Section 8.3.3(e)
(Cumulative Reductions Floor), on a Licensed Product-by-Licensed Product basis,
during any Calendar Quarter in which Transfer Price Payments are payable by
Torii to BioCryst pursuant to Section 8.3 (Transfer Price Payments to BioCryst)
with respect to a Licensed Product, Torii may credit against such Transfer Price
Payments payable to BioCryst pursuant to Section 8.3 (Transfer Price Payments to
BioCryst) with respect to such Licensed Product in the Territory in such
Calendar Quarter up to [***] of any royalty payments for which Torii is
responsible (i) under any Third Party IP Agreement entered into pursuant to
Section 12.4.4 (Responsibility for Costs), or (ii) under any agreement with a
Third Party entered into by Torii pursuant to Section 12.4.2 (Torii Identified
Rights), but in each case solely to the extent such royalty payments are made in
consideration for the acquisition or license of Patent Rights Controlled by a
Third Party that (in the opinion of counsel) would be infringed by the
Commercialization of the Licensed Product in the Field in the Territory.

 

(c)Reductions for Additional Development. Subject to Section 8.3.3(e)
(Cumulative Reductions Floor), on a Licensed Product-by-Licensed Product basis,
during any Calendar Quarter in which Transfer Price Payments are payable by
Torii to BioCryst pursuant to Section 8.3 (Transfer Price Payments to BioCryst)
with respect to a Licensed Product, Torii may credit (i) [***] of amounts
reimbursed to BioCryst as Additional First Approval Costs and Additional
Essential Element Expansion Costs and (ii) [***] of amounts reimbursed to
BioCryst as Additional Label Expansion Costs, in each case ((i) and (ii)), in
accordance with Section 4.1.3 (Additional Development) for the Licensed Product
against the Transfer Price Payments payable to BioCryst with respect to such
Licensed Product in the Territory in such Calendar Quarter.

 

-47-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

(d)Reductions for Territory-Specific Packaging and Labeling. If Torii conducts
any Territory-Specific Packaging and Labeling in accordance with Section 5.1.3
(Territory-Specific Packaging and Labeling), then, on a Calendar Quarterly
basis, to the extent equal to or less than the amount incurred on a quarterly
basis by or on behalf of BioCryst to perform Territory-Specific Packaging and
Labeling (adjusted with applicable CPI), Torii may deduct the external expenses
paid to the applicable CMO for the performance of such Territory-Specific
Packaging and Labeling.

 

(e)Cumulative Reductions Floor. Other than as a result of reductions permitted
under Section 5.6 (Supply Failure) and Section 8.3.3(d) (Reductions for
Territory-Specific Packaging and Labeling), in no event will the aggregate
amount of Transfer Price Payments due to BioCryst for a Licensed Product in the
Territory in any given Calendar Quarter during the Transfer Price Payment Term
for such Licensed Product in the Territory be reduced to less than fifty percent
(50%) of the amount that otherwise would have been due and payable to BioCryst
in such Calendar Quarter for such Licensed Product in the Territory but for the
reductions set forth in Section 8.3.3(a) (Generic Product Reduction), Section
8.3.3(b) (Third Party Patent Rights and Know-How), and Section 8.3.3(c)
(Reductions for Additional Development); provided that if any Calendar Quarter
Torii cannot apply any of the reductions permitted under Section 8.3.3(a)
(Generic Product Reduction), or Section 8.3.3(b) (Third Party Patent Rights and
Know-How), Section 8.3.3(c) (Reductions for Additional Development) as a result
of the foregoing cumulative reductions floor, then Torii may carry over such
amount to any subsequent Calendar Quarter and reduce the Transfer Price Payment
due for such Calendar Quarter, subject always to the restrictions of this
Section 8.3.3(e) (Cumulative Reductions Floor).

 

8.3.4Transfer Price Payment Reports and Payments. Commencing with the Calendar
Quarter during which the First Commercial Sale of a Licensed Product is made
anywhere in the Territory, within [***] after the end of each Calendar Quarter,
Torii will provide BioCryst with a detailed report that contains the following
information for the applicable Calendar Quarter, on a Licensed
Product-by-Licensed Product basis (each, a “Transfer Price Payment Report”): (a)
the amount of gross sales and Net Sales of each Licensed Product sold by Torii
and its Affiliates and Sublicensees in the Territory and all deductions used to
determine such Net Sales of each such Licensed Product for such Calendar
Quarter, (b) a calculation of the Transfer Price Payment due on such Net Sales
of each Licensed Product in the Territory, including any royalty reduction made
in accordance with Section 8.3.3(a) (Generic Product Reduction), Section
8.3.3(b) (Third Party Patent Rights and Know-How), Section 8.3.3(c) (Reductions
for Additional Development), or Section 8.3.3(d) (Reductions for
Territory-Specific Packaging and Labeling), (c) the exchange rate used for
converting Transfer Price Payments from Japanese Yen to Dollars, (d) any
withholding taxes required to be made from such Transfer Price Payments, and (e)
the quantity and description of each Licensed Product sold by Torii or its
Affiliate or Sublicensee in the Territory during such Calendar Quarter
comprising such Net Sales. Concurrent with the delivery of the applicable
Transfer Price Payment Report, but in any event within [***] after the end of
each Calendar Quarter, Torii will pay such the amount of the Transfer Price
Payments set forth in the applicable Transfer Price Payment Report to BioCryst
in Dollars. If requested by BioCryst, the Parties will seek to resolve any
questions or issues related to a Transfer Price Payment Report within [***]
following the receipt by BioCryst of each Transfer Price Payment Report.

 

-48-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

8.4Payments to Third Parties. Subject to Section 12.4 (Third Party In-Licenses)
and Section 8.3.3(b) (Third Party Patent Rights and Know-How), each Party will
be solely responsible for any payments due to Third Parties under any agreement
entered into by such Party prior to or after the Effective Date.

 

8.5Other Amounts Payable. With respect to any amounts owed under this Agreement
by one Party to the other for which no other invoicing and payment procedure is
specified hereunder, within [***] after the end of each Calendar Quarter, each
Party will provide an invoice, together with reasonable supporting
documentation, to the other Party for such amounts owed in respect of such
Calendar Quarter. The owing Party will pay any undisputed amounts within [***]
after the receipt of the invoice, and any disputed amounts owed by a Party will
be paid within [***] after resolution of the dispute.

 

8.6No Refunds. Except as expressly provided herein, all payments under this
Agreement will be irrevocable, non-refundable, and non-creditable.

 

8.7Accounting Standards. If a Party changes its general accounting principles
from the then-current standard (e.g., from GAAP to IFRS) at any time during the
Term, then at least [***]prior to adopting such change in principles, such Party
will provide written notice to the other Party of such change.

 

8.8Currency; Exchange Rate. All payments to be made by Torii to BioCryst or
BioCryst to Torii under this Agreement will be made in Dollars by electronic
funds transfer in immediately available funds to a bank account designated in
writing by BioCryst or Torii, as applicable. Conversion of Net Sales recorded in
local currencies will be converted to Dollars at the exchange rate set forth in
The Wall Street Journal or any successor thereto for the last day of the
Calendar Quarter in which the applicable payment obligation became due and
payable.

 

8.9Blocked Payments. If by reason of Applicable Law in any country or region, it
becomes impossible or illegal for a Party to transfer, or have transferred on
its behalf, payments owed the other Party hereunder, then such Party will
promptly notify the other Party of the conditions preventing such transfer and
such payments will be deposited in local currency in the relevant country or
region to the credit of the other Party in a recognized banking institution
designated by the other Party or, if none is designated by the other Party
within a period of [***], in a recognized banking institution selected by the
transferring Party, as the case may be, and identified in a written notice given
to the other Party.

 

8.10Late Payments. Any payments or portions thereof due hereunder that are not
paid on the date such payments are due under this Agreement will bear interest
at a rate equal to the lesser of: (a) [***] percentage points above the prime
rate as published by The Wall Street Journal or any successor thereto on the
first day of each Calendar Quarter in which such payments are overdue; or (b)
the maximum rate permitted by Applicable Law; in each case, calculated on the
number of days such payment is delinquent, compounded monthly.

 

-49-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

8.11Financial Records and Audits. Each Party will maintain complete and accurate
records in sufficient detail to permit the other Party to confirm the accuracy
of the amount of Additional Development Costs, Transfer Price Payments, costs
and expenses incurred by or on behalf of Torii in the performance of any Torii
Manufacturing Activities, and other amounts payable under this Agreement. Upon
reasonable prior notice, such records will be open during regular business hours
for a period of [***] from the creation of individual records for examination by
an independent certified public accountant selected by the examining Party and
reasonably acceptable to the other Party for the sole purpose of verifying for
the examining Party the accuracy of the financial reports furnished by the other
Party (the “Examined Party”) pursuant to this Agreement or of any payments made,
or required to be made, by such Examined Party pursuant to this Agreement;
provided that such independent accounting firm is subject to written obligations
of confidentiality and non-use applicable to each Party’s Confidential
Information that are at least as stringent as those set forth in Article 9
(Confidentiality; Publication). Such audit will not be (a) performed more
frequently than once per Calendar Year during the Term or once during the three
year period after the expiration or termination of this Agreement, (b) conducted
for any Calendar Year more than three years after the end of such year, or (c)
repeated for any Calendar Year or with respect to the same set of records
(unless a material discrepancy with respect to such records is discovered during
a prior audit). Such auditor will not disclose the Examined Party’s Confidential
Information to the examining Party or to any Third Party, except to the extent
such disclosure is necessary to verify the accuracy of the financial reports
furnished by the Examined Party or the amount of payments by the Examined Party
under this Agreement. In case of any underpayment, the Examined Party will pay
any amounts shown to be owed to the examining Party but unpaid within [***]
after the accountant’s report, plus interest (as set forth in Section 8.10 (Late
Payments)) from the original due date. In case of any overpayment, the amount of
such overpayment may first be credited from subsequent payments due to the
Examined Party hereunder, or if there is no such payment, then the Examined
Party will refund such any remaining amount of such overpayment to the examining
Party on the same terms as an underpayment. The examining Party will bear the
full cost of such audit unless such audit reveals an underpayment by the
Examined Party of more than [***] of the amount actually due for the time period
being audited, in which case the Examined Party will reimburse the examining
Party for the reasonable audit fees for such examination.

 

8.12Taxes.

 

8.12.1Taxes on Income. Except as set forth in this Section 8.12 (Taxes), each
Party will be solely responsible for the payment of any and all Taxes levied on
account of all payments it receives under this Agreement.

 

8.12.2Tax Cooperation. The Parties agree to cooperate with one another in
accordance with Applicable Law and use reasonable efforts to minimize Tax
withholding or similar obligations in respect of royalties, milestone payments,
and other payments made by each Party to the other Party under this Agreement.
Except as set forth under Section 8.12.5 (VAT Credits), to the extent either
Party (the “Paying Party”) is required to deduct and withhold Taxes on any
payment to the other Party (the “Recipient”), the Paying Party may deduct any
withholding tax required to pay or withhold on behalf of BioCryst from the
payments pursuant to this Agreement as long as Paying Party will (a) pay the
amount of such Taxes to the proper Governmental Authority in a timely manner,
and (b) promptly transmit to the Recipient an official tax certificate or other
evidence of such payment sufficient to enable the Recipient to claim such
payment of Taxes on the Recipient’s applicable tax returns. To the extent
practicable, the Paying Party will provide the Recipient with advance notice
prior to withholding any Taxes from payments payable to the Recipient and will
provide the Recipient with a commercially reasonable period of time to claim an
exemption or reduction in otherwise applicable Taxes. The Recipient will provide
the Paying Party any tax forms that may be reasonably necessary in order for the
Paying Party to not withhold Tax or to withhold Tax at a reduced rate under an
applicable bilateral income tax treaty, to the extent the Paying Party is
legally able to do so. The Recipient will use reasonable efforts to provide any
such tax forms to the Paying Party in advance of the due date. Each Party will
provide the other with reasonable assistance to enable the recovery, as
permitted by Applicable Law, of withholding Taxes or similar obligations
resulting from payments made under this Agreement, such recovery to be for the
benefit of the Paying Party if the Paying Party is the Party bearing such
withholding Tax under this Section 8.12 (Taxes). In addition, the Parties will
cooperate in accordance with Applicable Law to minimize indirect Taxes (such as
VAT, sales tax, consumption tax, and other similar Taxes) in connection with
this Agreement. In the event of any inconsistency between this Section 8.12
(Taxes) and Section 8.12.5 (VAT Credits), Section 8.12.5 (VAT Credits) will take
precedence. For the avoidance of doubt, any payments delayed by the Paying Party
in order to allow the Recipient to claim an exemption or reduction in otherwise
applicable Taxes will not be subject to Section 8.10 (Late Payments).

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

8.12.3Changes in Domicile. Notwithstanding any provision to the contrary in this
Agreement, if the Paying Party assigns, transfers, or otherwise disposes of some
or all of its rights and obligations to any Person and if, as a result of such
action, the withholding or deduction of Tax required by Applicable Law with
respect to payments under this Agreement is increased, then any amount payable
to the Recipient under this Agreement will be increased to take into account
such withheld Taxes as may be necessary so that, after making all required
withholdings (including withholdings on the withheld amounts), the Recipient
receives an amount equal to the sum it would have received had no such
withholding been made.

 

8.12.4Returns. All transfer, documentary, sales, use, stamp, registration, and
other such Taxes, and any conveyance fees, recording charges, and other fees and
charges (including any penalties and interest) incurred in connection with
consummation of the transactions contemplated hereby, if any, will be borne and
paid by the Paying Party. The Paying Party will prepare and timely file all tax
returns required to be filed in respect of any such Taxes. The Parties will
reasonably cooperate in accordance with Applicable Law to minimize transfer
Taxes in connection with this Agreement.

 

8.12.5VAT Credits. All payments due to BioCryst from Torii pursuant to this
Agreement will be paid without any deduction for any VAT that Torii may be
required to pay to any tax authorities in the Territory. BioCryst will use
reasonable efforts to assist Torii to minimize and obtain all available
exemptions from such VAT or other taxes, but if applicable, Torii will pay any
such VAT to the proper taxing authorities upon receipt of a valid VAT invoice
(where such invoice is required under local VAT laws). If Torii is required to
pay or BioCryst is required to report, any such VAT, then Torii will increase
the amount of any and all payments under this Agreement upon which such VAT is
due as may be necessary so that after making any payments in respect of any such
VAT, BioCryst receives an amount equal to the sum that it would have received
had no such VAT been required to be paid on such amount. Torii will promptly
provide to BioCryst applicable receipts evidencing payment of such VAT and other
documentation reasonably requested by Torii.

 

-51-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

Article 9
CONFIDENTIALITY; PUBLICATION

 

9.1Duty of Confidence. Subject to the other provisions of this Article 9
(Confidentiality; Publication):

 

9.1.1except to the extent expressly authorized by this Agreement, all
Confidential Information of a Party (the “Disclosing Party”) will be maintained
in confidence and otherwise safeguarded, and not published or otherwise
disclosed, by the other Party (the “Receiving Party”) and its Affiliates for the
Term and for [***] thereafter;

 

9.1.2the Receiving Party will treat all Confidential Information provided by the
Disclosing Party with the same degree of care as the Receiving Party uses for
its own similar information, but in no event less than a reasonable degree of
care;

 

9.1.3the Receiving Party may only use any Confidential Information of the
Disclosing Party for the purposes of performing its obligations or exercising
its rights under this Agreement;

 

9.1.4a Receiving Party may disclose Confidential Information of the Disclosing
Party to: (a) such Receiving Party’s Controlled Affiliates and JT (with respect
to Torii) or Affiliates (with respect to BioCryst), licensees, Sublicensees, and
Subcontractors; and (b) employees, directors, officers, agents, contractors,
consultants, attorneys, accountants, banks, investors, and advisors of the
Receiving Party and its Controlled Affiliates and JT (with respect to Torii) or
Affiliates (with respect to BioCryst), licensees, Sublicensees, and
Subcontractors in each case ((a) and (b)), to the extent reasonably necessary
for the purposes of, and for those matters undertaken pursuant to, this
Agreement; provided that such Persons are bound by legally enforceable
obligations of confidentiality and non-use with respect to the Disclosing
Party’s Confidential Information no less stringent than the confidentiality and
non-use obligations set forth in this Agreement. Each Party will remain
responsible for any failure by its Controlled Affiliates and JT (with respect to
Torii) or Affiliates (with respect to BioCryst), licensees, Sublicensees, and
Subcontractors, and its and its Controlled Affiliates and JT (with respect to
Torii) or its Affiliates’(with respect to BioCryst), licensees’, and
Sublicensees’ respective employees, directors, officers, agents, consultants,
attorneys, accountants, banks, investors, advisors, and contractors, in each
case, to treat such Confidential Information as required under this Section 9.1
(Duty of Confidence) (as if such Controlled Affiliates and JT (with respect to
Torii), Affiliates (with respect to BioCryst), licensees, Sublicensees,
Subcontractors, employees, directors, officers agents, consultants, advisors,
attorneys, accountants, banks, investors, and contractors were Parties directly
bound to the requirements of this Section 9.1 (Duty of Confidence)); and

 

9.1.5each Party will promptly notify the other Party of any misuse or
unauthorized disclosure of the other Party’s Confidential Information.

 

9.2Confidential Information. The BioCryst Know-How will be the Confidential
Information of BioCryst. The Joint Know-How and the terms of this Agreement will
be the Confidential Information of both Parties. The Torii Know-How will be the
Confidential Information of Torii. Except as provided in Section 9.4 (Authorized
Disclosures) and Section 9.7 (Publicity; Use of Names), neither Party nor its
Affiliates may disclose the existence or the terms of this Agreement.

 

9.3Exemptions. Information of a Disclosing Party will not be Confidential
Information of such Disclosing Party to the extent that the Receiving Party can
demonstrate through competent evidence that such information:

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

9.3.1is known by the Receiving Party or any of its Affiliates without an
obligation of confidentiality at the time of its receipt from the Disclosing
Party, and not through a prior disclosure by or on behalf of the Disclosing
Party, as documented by the Receiving Party’s business records;

 

9.3.2is generally available to the public before its receipt from the Disclosing
Party;

 

9.3.3became generally available to the public or otherwise part of the public
domain after its disclosure by the Disclosing Party and other than through any
act or omission of the Receiving Party or any of its Affiliates or disclosees in
breach of this Agreement;

 

9.3.4is subsequently disclosed to the Receiving Party or any of its Affiliates
without obligation of confidentiality by a Third Party who may rightfully do so
and is not under a conflicting obligation of confidentiality to the Disclosing
Party; or

 

9.3.5is developed by the Receiving Party or any of its Affiliates independently
and without use of or reference to any Confidential Information received from
the Disclosing Party, as documented by the Receiving Party’s business records.

 

No combination of features or disclosures will be deemed to fall within the
foregoing exclusions merely because individual features are published or
available to the general public or in the rightful possession of the Receiving
Party unless the combination itself and principle of operation are published or
available to the general public or in the rightful possession of the Receiving
Party.

 

9.4Authorized Disclosures.

 

9.4.1Permitted Circumstances. Notwithstanding the obligations set forth in
Section 9.1 (Duty of Confidence) and Section 9.6 (Publications), a Party may
disclose the other Party’s Confidential Information (including this Agreement
and the terms herein) to the extent such disclosure is reasonably necessary in
the following situations:

 

(a)(i) the Patent Prosecution of BioCryst Patent Rights, Joint Patent Rights, or
Torii Patent Rights, in each case, as contemplated by this Agreement; or (ii)
Regulatory Submission and other filings with Governmental Authorities (including
Regulatory Authorities), as necessary for the Exploitation of a Licensed Product
in accordance with the rights and obligations of the applicable Party under this
Agreement;

 

(b)disclosure of this Agreement, its terms, and the status and results of
Exploitation of the Licensed Product to actual or bona fide potential investors,
acquirors, (sub)licensees, lenders, and other financial or commercial partners
(including in connection with any royalty factoring transaction), and their
respective attorneys, accountants, banks, investors, and advisors, solely for
the purpose of evaluating or carrying out an actual or potential investment,
acquisition, (sub)license, debt transaction, or collaboration; provided that, in
each such case, on the condition that such Persons are bound by obligations of
confidentiality and non-use at least as stringent as those set forth in Article
9 (Confidentiality; Publication) or otherwise customary for such type and scope
of disclosure; provided that any such disclosure is limited to the maximum
extent practicable for the particular context in which it is being disclosed;

 

-53-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

(c)such disclosure is required to comply with Applicable Law (whether generally
or in pursuit of an application for listing of securities), including the United
States Securities and Exchange Commission or equivalent foreign agency or
regulatory body, or applicable stock exchange rules, including the Tokyo Stock
Exchange rules, or otherwise required by judicial or administrative process,
provided that in each such event, as promptly as reasonably practicable and to
the extent not prohibited by Applicable Law or judicial or administrative
process, such Party will notify the other Party of such required disclosure and
provide a draft of the disclosure to the other Party reasonably in advance of
such filing or disclosure for the other Party’s review and comment. The
non-disclosing Party will provide any comments as soon as practicable, and the
disclosing Party will consider in good faith any timely comments provided by the
non-disclosing Party; provided that the disclosing Party may or may not accept
such comments in its sole discretion. Confidential Information that is disclosed
in order to comply with Applicable Law or by judicial or administrative process
pursuant to this Section 9.4.1(c) (Permitted Circumstances), in each case, will
remain otherwise subject to the confidentiality and non-use provisions of this
Article 9 (Confidentiality; Publication) with respect to the Party disclosing
such Confidential Information, and such Party will take all steps reasonably
necessary, including seeking of confidential treatment or a protective order for
a period of at least [***] (to the extent permitted by Applicable Law or
Governmental Authority), to ensure the continued confidential treatment of such
Confidential Information, and each Party will be responsible for its own legal
and other external costs in connection with any such filing or disclosure
pursuant to this Section 9.4.1(c) (Permitted Circumstances); or

 

(d)disclosure pursuant to Section 9.6 (Publications) and Section 9.7 (Publicity;
Use of Name).

 

9.4.2Confidential Treatment. Notwithstanding any provision to the contrary set
forth in this Agreement, in each case of a disclosure to be made pursuant to
Section 9.4.1(b) or Section 9.4.1(c) (Permitted Circumstances) by either Party,
except where impractical, where some or all of the terms of this Agreement are
to be disclosed, such Party will provide to the other Party a redacted version
of the applicable terms of this Agreement to be made in connection with any such
disclosure reasonably in advance of such disclosure and consider in good faith
the other Party’s comments. Subject to the foregoing, but notwithstanding any
other provision to the contrary set forth in this Agreement, if a Party is
required or permitted to make a disclosure of the other Party’s Confidential
Information pursuant to Section 9.4.1 (Permitted Circumstances), then it will,
to the extent not prohibited by Applicable Law or judicial or administrative
process, except where impracticable, give reasonable advance notice to the other
Party of such proposed disclosure and use reasonable efforts to secure
confidential treatment of such information and will only disclose that portion
of Confidential Information that is legally required to be disclosed as advised
by its legal counsel. In any event, each Party agrees to take all reasonable
action to avoid disclosure of Confidential Information of the other Party
hereunder.

 

9.5Tax Treatment. Nothing in Section 9.1 (Duty of Confidence) or 9.4 (Authorized
Disclosures) will limit either Party in any way from disclosing to any Third
Party such Party’s U.S. or foreign income Tax treatment and the U.S. or foreign
income Tax structure of the transactions relating to such Party that are based
on or derived from this Agreement, or materials of any kind (including opinions
or other Tax analyses) relating to such Tax treatment or Tax structure, except
to the extent that nondisclosure of such matters is reasonably necessary in
order to comply with applicable securities laws.

 

-54-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

9.6Publications.

 

9.6.1Torii may publicly present or publish any Clinical Trial or
Commercialization data, non-clinical or preclinical data, or any associated
results, data, or conclusions generated by or on behalf of Torii pursuant to
this Agreement (each such proposed presentation or publication, a “Publication”)
solely if such Publication is in accordance with a written global publication
and communication strategy with respect to the Licensed Product as reviewed,
discussed, and determined by the JSC and updated by the JSC from time to time
during the Term (the “Publication and Communication Strategy”), and subject to
the additional limitations set forth in this Section 9.6 (Publications). If
Torii desires to publicly present or publish a Publication in accordance with
the foregoing sentence that is in accordance with the Publication and
Communication Strategy, then Torii will provide BioCryst (including the Alliance
Manager and all BioCryst members of the JSC) with a copy of such proposed
Publication at least [***] prior to the earlier of its presentation or intended
submission for publication (such applicable period, the “Review Period”). Torii
agrees that it will not submit or present any Publication until (a) BioCryst has
provided written comments during such Review Period on the material in such
Publication, or (b) the applicable Review Period has elapsed without written
comments from BioCryst, in which case Torii may proceed and the Publication will
be considered approved in its entirety. If Torii receives written comments from
BioCryst on any Publication during the applicable Review Period, then it will
consider BioCryst’s comments in good faith and incorporate such comments where
appropriate. Notwithstanding any provision to contrary set forth in this
Agreement, Torii will (i) delete any Confidential Information of BioCryst that
BioCryst identifies for deletion in BioCryst’s written comments, (ii) delete any
Clinical Trial data, results, conclusions, or other related information for a
Licensed Product, the publication of which BioCryst determines, in its sole
discretion, would conflict with BioCryst’s global publication strategy with
respect to the Licensed Product, and (iii) delay such Publication for a period
of up to an additional [***] after the end of the applicable Review Period to
enable BioCryst to draft and file one or more patent applications with respect
to any subject matter to be made public in such Publication. Torii agrees to
acknowledge the contributions of BioCryst and the employees of BioCryst, in each
case, in all Publications as scientifically appropriate. Torii will require its
Controlled Affiliates and Sublicensees to comply with the obligations of this
Section 9.6 (Publications) as if they were Torii, and Torii will be liable for
any non-compliance of such Persons.

 

9.6.2BioCryst Publications. If BioCryst desires to publicly present or publish
any Clinical Trial or Commercialization data, non-clinical or preclinical data,
or any associated results, data, or conclusions generated by or on behalf of
BioCryst pursuant to this Agreement, then BioCryst will provide Torii with an
initial draft of such proposed publication as soon as reasonably practicable. If
Torii notifies BioCryst that any such publication may have negative impact on
the Development or Commercialization of the Licensed Product in the Field in the
Territory, then BioCryst will consider Torii’s comments in good faith.

 

9.7Publicity; Use of Names.

 

9.7.1Press Release. The Parties have agreed on separate press releases
announcing this Agreement, each as set forth on Schedule 9.7.1 (Press Release),
to be issued by the applicable Party on such date and time as may be agreed by
the Parties. Other than the press releases set forth on Schedule 9.7.1 (Press
Release) and the public disclosures permitted by this Section 9.7 (Publicity;
Use of Names) and Section 9.4 (Authorized Disclosures), the Parties agree that
the portions of any other news release or other public announcement relating to
this Agreement or the performance hereunder that would disclose information,
other than that which is already in the public domain, and remains true,
correct, and current, will first be reviewed and approved by both Parties (with
such approval not to be unreasonably withheld). However, the Parties agree that
after (a) a disclosure pursuant to Section 9.7 (Publicity; Use of Names) or
Section 9.4 (Authorized Disclosures) or (b) the issuance of a press release
(including the initial press releases) or other public announcement pursuant to
this Section 9.7.1 (Press Release) that has been reviewed and approved by the
other Party, the disclosing Party may make subsequent public disclosures
reiterating such information without having to obtain the other Party’s prior
consent and approval so long as the information in such press release or other
public announcement remains true, correct, and the most current information with
respect to the subject matters set forth therein. Similarly, after a Publication
has been made available to the public, each Party may post such Publication or a
link to it on its corporate website (or any website managed by such Party in
connection with a Clinical Trial for a Licensed Product, as appropriate) without
the prior written consent of the other Party, so long as the information in such
Publication remains true, correct, and the most current information with respect
to the subject matters set forth therein.

 

-55-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

9.7.2Disclosures by BioCryst. Notwithstanding any provision to the contrary set
forth in this Agreement, BioCryst has the right to publicly disclose (in
written, oral, or other form): (a) the achievement of Milestone Events under
this Agreement (including the amount, payment, and timing of any such Milestone
Event); (b) any information relating to any Clinical Trial for a Licensed
Product, including the commencement, completion, material data, or key results,
whether or not conducted under this Agreement; and (c) the achievement of
Regulatory Approval for a Licensed Product. To the extent that any such public
disclosure to be made by BioCryst in writing is likely, in BioCryst’s
discretion, to have an impact on the Commercialization of the Licensed Product
in the Field in the Territory, BioCryst will use reasonable efforts to provide
to Torii copies of such disclosure in advance of publication thereof and
consider in good faith any comments from Torii regarding such disclosure.

 

9.7.3Use of Names. Each Party will have the right to use the other Party’s name
and logo as otherwise set forth in this Agreement and in presentations, its
website, collateral materials, and corporate overviews to describe the
collaboration relationship, as well as in taglines of press releases issued
pursuant to this Section 9.7 (Publicity; Use of Names); provided that each Party
will use the other Party’s corporate name in such manner (a) that the
distinctiveness, reputation, and validity of any trademarks and corporate or
trade names of such other Party will not be impaired, (b) consistent with best
practices used by such other Party for its other collaborators, and (c) in
accordance with the other Party’s written instruction. Except as permitted under
this Section 9.7 (Publicity; Use of Names) or with the prior express written
permission of the other Party, neither Party will use the name, trademark, trade
name, or logo of the other Party or its Affiliates (in case of BioCryst) or
Controlled Affiliates (in case of Torii) or their respective employees in any
publicity, promotion, news release, or disclosure relating to this Agreement or
its subject matter except as may be required by Applicable Law. Each Party will
use the other Party’s corporate name in the form and format provided or
otherwise approved by such other Party in all publicity relating to this
Agreement, including the initial press release and all subsequent press
releases. Torii will include explanatory text such as “Developed by BioCryst” in
all publicity, promotion, news releases, or disclosures relating to the Licensed
Product, or such other similar or otherwise customary text provided by Torii and
reasonably acceptable to BioCryst.

 

-56-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

9.8Attorney-Client Privilege. Neither Party is waiving, nor will be deemed to
have waived or diminished, any of its attorney work product protections,
attorney-client privileges or similar protections and privileges or the like as
a result of disclosing information pursuant to this Agreement, or any of its
Confidential Information (including Confidential Information related to pending
or threatened litigation) to the Receiving Party, regardless of whether the
Disclosing Party has asserted, such privileges and protections. The Parties: (a)
share a common legal and commercial interest in such disclosure that is subject
to such privileges and protections; (b) are or may become joint defendants in
proceedings to which the information covered by such protections and privileges
relates; (c) intend that such privileges and protections remain intact should
either Party become subject to any actual or threatened proceeding to which the
Disclosing Party’s Confidential Information covered by such protections and
privileges relates; and (d) intend that after the Effective Date both the
Receiving Party and the Disclosing Party will have the right to assert such
protections and privileges. Notwithstanding any provision to the contrary set
forth in this Agreement, nothing in this Section 9.8 (Attorney-Client Privilege)
will apply with respect to a Dispute between the Parties (including their
respective Affiliates).

 

Article 10
REPRESENTATIONS, WARRANTIES, AND COVENANTS

 

10.1Representations and Warranties of Each Party. Each Party represents and
warrants to the other Party as of the Effective Date as follows:

 

10.1.1It is a corporation or limited company duly organized, validly existing,
and, as applicable, in good standing under the laws of the jurisdiction of its
organization, and it has the full right, power and authority to enter into this
Agreement and to perform its obligations hereunder.

 

10.1.2It has not been Debarred/Excluded and no proceeding that could result it
in being Debarred/Excluded is pending, and neither it nor any of its Affiliates
has used, in any capacity in the performance of obligations relating to the
Licensed Product, any employee, subcontractor, consultant, agent,
representative, or other Person who has been Debarred/Excluded.

 

10.1.3All consents, approvals and authorizations from all Governmental
Authorities or other Third Parties required to be obtained by such Party in
connection with this Agreement have been obtained.

 

10.1.4This Agreement has been duly executed by it and 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 Applicable Law or
regulation of any court, governmental body, or administrative or other agency
having jurisdiction over it.

 

10.2Representations and Warranties of BioCryst. BioCryst represents and warrants
to Torii as of the Effective Date as follows:

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

10.2.1BioCryst is the sole and exclusive owner of the BioCryst Technology
existing as of the Effective Date.

 

10.2.2BioCryst has sufficient legal or beneficial title of, and rights under,
the BioCryst Technology to grant to Torii the licenses set forth in this
Agreement, and it has not granted to any Third Party any license or other right
under the BioCryst Technology that is inconsistent with the licenses granted to
Torii hereunder.

 

10.2.3Schedule 1.31 (BioCryst Patent Rights) sets forth a complete and accurate
list of the BioCryst Patent Rights owned by BioCryst. BioCryst owns all rights,
title, and interests in and to all BioCryst Patent Rights set forth on Schedule
1.31 (BioCryst Patent Rights). To the Knowledge of BioCryst, the issued patents
included in the BioCryst Patent Rights are valid and enforceable patents and no
Third Party has challenged or threatened to challenge the scope, validity or
enforceability of any BioCryst Patent Rights, and no patent application included
in the BioCryst Patent Rights has lapsed (in the case of a provisional patent
application), or been cancelled, withdrawn, or abandoned without the possibility
of revival. BioCryst or its Affiliates have timely paid all filing and renewal
fees payable with respect to such BioCryst Patent Rights.

 

10.2.4BioCryst or its Affiliates have obtained from all inventors of BioCryst
Technology owned by BioCryst or its Affiliates valid and enforceable agreement
assigning to BioCryst each such inventor’s entire right, title, and interest in
and to all such BioCryst Technology.

 

10.2.5There is no (a) claim, demand, suit, proceeding, arbitration, inquiry,
investigation or other legal action of any nature, civil, criminal, regulatory
or otherwise, pending or, to the Knowledge of BioCryst, threatened against
BioCryst or any of its Affiliates or (b) judgment or settlement against or owed
by BioCryst or any of its Affiliates, in each case ((a) and (b)), in connection
with the BioCryst Technology.

 

10.2.6To the Knowledge of BioCryst, the use, Development, Manufacture, having
Manufactured, or Commercialization by BioCryst or Torii or their respective
Affiliates of the Licensed Product in the Field as formulated and Manufactured
as of the Effective Date, or as intended to be formulated and Manufactured as of
the Effective Date (a) does not and will not infringe any issued Patent Right of
any Third Party and (b) will not infringe the claims of any published patent
application of any Third Party if and when such claims were to issue in their
current form.

 

10.2.7BioCryst does not have any Knowledge of any infringement or
misappropriation of any BioCryst Technology by any Third Party.

 

10.2.8Except as set forth on Schedule 10.2.8, the BioCryst Technology is free
and clear of liens, charges, or encumbrances other than licenses granted to or
by Third Parties that are not inconsistent with the rights and licenses granted
to Torii hereunder.

 

10.2.9There is no pending or, to BioCryst’s Knowledge, threatened (in writing)
litigation, nor has BioCryst received any written notice from any Third Party,
asserting or alleging that the Exploitation of a Licensed Product prior to the
Effective Date in the Field in or for the Territory infringed or misappropriated
the intellectual property rights of such Third Party.

 

10.2.10The BioCryst Technology includes all Patent Rights in the Territory that
are owned by BioCryst or its Affiliates that Cover a Licensed Product for use in
the Field in the Territory.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

10.2.11To the Knowledge of BioCryst, there are no, and there have been no,
material safety issues relating to the Licensed Product in the Field.

 

10.2.12To the Knowledge of BioCryst, there is no fact or circumstance that would
reasonably be expected to prevent the Licensed Product from receiving Regulatory
Approval in the Field in the Territory.

 

10.2.13There are no legal claims, judgments, or settlements against or owed by
BioCryst or any of its Affiliates, or pending or, to BioCryst’s Knowledge,
threatened, legal claims or litigation, in each case, relating to antitrust,
anti-competition, or Anti-Corruption Law violations.

 

10.2.14To its Knowledge, neither BioCryst nor any of its Affiliates, or its or
their directors, officers, employees, distributors, agents, representatives,
sales intermediaries, or other Third Parties acting on behalf of BioCryst or any
of its Affiliates:

 

(a)has taken any action in violation of any applicable Anti-Corruption Laws; or

 

(b)has corruptly offered, paid, given, promised to pay or give, or authorized
the payment or gift of anything of value, directly or indirectly, to any Public
Official, for the purposes of:

 

(i)influencing any act or decision of any Public Official in his or her official
capacity;

 

(ii)inducing such Public Official to do or omit to do any act in violation of
his or her lawful duty;

 

(iii)securing any improper advantage; or

 

(iv)inducing such Public Official to use his or her influence with a government,
governmental entity, or commercial enterprise owned or controlled by any
government (including state-owned or controlled veterinary, laboratory or
medical facilities) in obtaining or retaining any business whatsoever.

 

10.3Representations and Warranties of Torii. Torii represents and warrants to
BioCryst as of the Effective Date as follows:

 

10.3.1Neither Torii nor its Affiliates are Developing, or otherwise Control, any
pharmaceutical or biologic product for HAE-P or HAE-A.

 

10.3.2Except [***], there are no legal claims, judgments, or settlements against
or owed by Torii or any of its Controlled Affiliates, or pending or, to Torii’s
Knowledge, threatened, legal claims or litigation, in each case, relating to
antitrust, anti-competition, or Anti-Corruption Law violations.

 

10.3.3Torii has sufficient financial wherewithal to (a) perform all of its
obligations set forth under this Agreement, and (b) meet all of its obligations
that come due in the ordinary course of business.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

10.3.4Torii has, or can readily obtain, sufficient technical, regulatory, and
commercial expertise to perform all of its obligations pursuant to this
Agreement, including all Torii Activities, in each case, with respect to the
Licensed Product in the Field in the Territory as contemplated under this
Agreement.

 

10.3.5To its Knowledge, neither Torii nor any of its Controlled Affiliates, or
its or their directors, officers, employees, distributors, agents,
representatives, sales intermediaries, or other Third Parties acting on behalf
of Torii or any of its Controlled Affiliates:

 

(a)has taken any action in violation of any applicable Anti-Corruption Laws; or

 

(b)has corruptly offered, paid, given, promised to pay or give, or authorized
the payment or gift of anything of value, directly or indirectly, to any Public
Official, for the purposes of:

 

(i)influencing any act or decision of any Public Official in his or her official
capacity;

 

(ii)inducing such Public Official to do or omit to do any act in violation of
his or her lawful duty;

 

(iii)securing any improper advantage; or

 

(iv)inducing such Public Official to use his or her influence with a government,
governmental entity, or commercial enterprise owned or controlled by any
government (including state-owned or controlled veterinary, laboratory or
medical facilities) in obtaining or retaining any business whatsoever.

 

10.3.6Except as set forth on Schedule 10.3.6, none of the officers, directors,
or employees of Torii or of any of its Controlled Affiliates or agents acting on
behalf of Torii or any of its Controlled Affiliates, in each case, that are
employed or reside outside the United States, is a Public Official.

 

10.4Covenant Not to Sue. Torii will not, and will cause its Affiliates not to,
directly or indirectly with or through any Third Party, sue, assert any claim or
counterclaim against, or otherwise participate in any action or proceeding
against BioCryst or its Affiliates or their respective licensees or Sublicensees
in any case involving the Exploitation of the Licensed Product that claims or
otherwise asserts that BioCryst or its Affiliates or their respective licensees
or Sublicensees is or are liable for infringing any Patent Rights Controlled by
Torii or any of its Affiliates. BioCryst and each of its Affiliates and their
respective Sublicensees that are not party to this Agreement are intended third
party beneficiaries of this Section 10.4 (Covenant Not to Sue).  If Torii or any
of its Affiliates sells, assigns, exclusively licenses, transfers, or otherwise
grants any right to a Third Party under any Patent Rights Controlled by Torii or
any of its Affiliates that would be infringed by the Exploitation of the
Licensed Product, then Torii or such Affiliate, as applicable, will require such
purchaser, assignee, licensee, or transferee to agree in writing to be bound by
the same covenant to the same extent as made by Torii and its Affiliates in this
Section 10.4 (Covenant Not to Sue).

 

10.5Covenants of BioCryst. BioCryst will comply with its obligations under the
agreements set forth on Schedule 10.2.8 so as to not have an adverse effect on
the licenses granted to Torii under the BioCryst Technology in this Agreement.
BioCryst will inform Torii as promptly as practicable if BioCryst fails to
comply with any such obligation.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

10.6Covenants of Each Party. Each Party covenants to the other Party that:

 

10.6.1In the course of performing its obligations or exercising its rights under
this Agreement, it will comply with all Applicable Law, and will not employ or
engage, and if so employed and engaged, will thereafter terminate any Person who
has been Debarred/Excluded (including any Subcontractor), or is the subject of
any proceedings that could result in such Person being Debarred/Excluded.

 

10.6.2Notwithstanding any provision to the contrary in this Agreement, each
Party agrees as follows:

 

(a)It will not, in the performance of activities under this Agreement, perform
any actions that are prohibited by any Anti-Corruption Laws that may be
applicable to one or both Parties.

 

(b)It will not, in the performance of activities under this Agreement, directly
or indirectly, make any payment, or offer or transfer anything of value, or
agree or promise to make any payment or offer or transfer anything of value, to
a government official or government employee, to any political party or any
candidate for political office or to any other Third Party with the purpose of
influencing decisions related to either Party or its business in a manner that
would violate Anti-Corruption Laws.

 

(c)It will, no later than [***] following the other Party’s written request,
which request may not be made more than once a Calendar Year, verify in writing
that to its Knowledge, there have been no violations of Anti-Corruption Laws by
it or its Controlled Affiliates (with respect to Torii) or Affiliates (with
respect to BioCryst) or Sublicensees, or persons employed by or Subcontractors
used by it or its Controlled Affiliates (with respect to Torii) or Affiliates
(with respect to BioCryst) or Sublicensees in the performance of this Agreement,
or will provide details of any exception to the foregoing.

 

(d)It will maintain records (financial and otherwise) and supporting
documentation related to the subject matter of this Section 10.6 (Covenants of
the Each Party) in order to document or verify compliance with the provisions of
this Section 10.6 (Covenants of Each Party), and upon request of the other Party
upon reasonable advance notice, will provide the other Party or its
representative with access to such records for purposes of verifying compliance
with the provisions of this Section 10.6(Covenants of Each Party).

 

10.7NO OTHER WARRANTIES. EXCEPT AS EXPRESSLY STATED IN THIS Article 10
(REPRESENTATIONS, WARRANTIES, AND COVENANTS), (A) NO REPRESENTATION, CONDITION,
OR WARRANTY WHATSOEVER IS MADE OR GIVEN BY OR ON BEHALF OF BIOCRYST OR TORII;
(B) ALL OTHER CONDITIONS AND WARRANTIES WHETHER ARISING BY OPERATION OF LAW OR
OTHERWISE ARE EXPRESSLY EXCLUDED, INCLUDING ANY CONDITIONS AND WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, OR NON-INFRINGEMENT;
AND (C) ANY INFORMATION PROVIDED BY EITHER PARTY OR ITS AFFILIATES IS MADE
AVAILABLE ON AN “AS IS” BASIS WITHOUT WARRANTY WITH RESPECT TO COMPLETENESS,
COMPLIANCE WITH REGULATORY STANDARDS OR REGULATIONS, OR FITNESS FOR A PARTICULAR
PURPOSE OR ANY OTHER KIND OF WARRANTY WHETHER EXPRESS OR IMPLIED.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

10.8Compliance with Laws. Torii understands and acknowledges that BioCryst is
subject to regulation by Governmental Authorities in the U.S., including the
U.S. Department of Commerce and the U.S. Treasury Department's Office of Foreign
Assets Control, both of which regulate the import, export, and diversion of
certain products and technology from and to certain countries. Any and all
obligations of BioCryst to provide the Licensed Product, as well as any other
technical information or assistance, and all rights on the part of Torii to
perform its obligations hereunder, will be subject in all respects to such
Applicable Law in the U.S. as will from time to time govern the license and
delivery of technology and products abroad by persons subject to the
jurisdiction of the United States, including regulations promulgated under
Executive Order No. 12924 of August 19, 1994 issued pursuant to the President’s
authority under the International Emergency Economic Powers Act, Title 50 U.S.
C., Chapter 35, Section 1701 et seq. and those contained in Title 31, Part 500
of the U.S. Code of Federal Regulations. Torii will cooperate with BioCryst
including providing required documentation, in order to comply with any and all
Applicable Law in the U.S. Torii will comply with all Applicable Law in the U.S.
governing exports in effect from time to time that are applicable to BioCryst as
if such laws and regulations were applicable to Torii. If any rights or
obligations hereunder are or become illegal or the subject of sanctions or
restrictions, then BioCryst will have the right, in its sole discretion, to
terminate, without penalty and immediately upon written notice, the provisions
of this Agreement which in BioCryst’s sole discretion relate to such
restrictions.

 

Article 11
INDEMNIFICATION

 

11.1By Torii. Torii will indemnify and hold harmless BioCryst and its
Affiliates, and their respective directors, officers, employees, successors,
heirs and assigns, and agents (individually and collectively, the “BioCryst
Indemnitees”) from and against all Losses incurred in connection with any Third
Party Claims to the extent arising from or relating to (a) the Exploitation of
the Licensed Product by or on behalf of Torii or any of its Affiliates,
Sublicensees, or Subcontractors, including product liability claims arising from
such Exploitation (except those derived from rom failure of the Licensed Product
Manufactured by or on behalf of BioCryst to conform with the applicable
specifications therefor or to be Manufactured in accordance with GMP), (b)
Torii’s actions (or omissions) in the performance of its obligations with
respect to Regulatory Submissions or interactions with Regulatory Authorities,
in each case, as the Regulatory Responsible Party, (c) the negligence or willful
misconduct of Torii or any of its Affiliates, Sublicensees, or Subcontractors,
(d) Torii’s breach of any of its representations, warranties, covenants, or
obligations set forth in or entered into pursuant to this Agreement, (e) the
failure of Torii or any of its Affiliates, Sublicensees, or Subcontractors to
abide by any Applicable Law, or (f) any claim or demand from any employee or
contractor of Torii or its Affiliate who is an inventor of any Joint Technology
with respect to the ownership thereof, in each case of clauses (a) through (f)
above, except to the extent such Third Party Claims arise out of a BioCryst
Indemnitee’s negligence or willful misconduct, breach of this Agreement, or
failure to abide by any Applicable Law.

 

11.2By BioCryst. BioCryst will indemnify and hold harmless Torii, its
Affiliates, and their directors, officers, employees, successors, heirs and
assigns, and agents (individually and collectively, the “Torii Indemnitees”)
from and against all Losses incurred in connection with any Third Party Claims
to the extent arising from or relating to (a) the Exploitation of the Licensed
Product by or on behalf of BioCryst or any of its Affiliates, licensees (not
including Torii or its Affiliates, Sublicensees, or its Subcontractors),
Sublicensees, or Subcontractors, including product liability claims arising from
such Exploitation (including those derived from failure of the Licensed Product
Manufactured by or on behalf of BioCryst to conform with the applicable
specifications therefor or to be Manufactured in accordance with GMP), and
including such Exploitation after the effective date of termination of this
Agreement, (b) BioCryst’s actions (or omissions) in the performance of its
obligations with respect to Regulatory Submissions or interactions with
Regulatory Authorities, in each case, as the Regulatory Responsible Party, (c)
the negligence or willful misconduct of BioCryst or any of its Affiliates,
licensees (not including Torii or its Affiliates, Sublicensees, or its
Subcontractors), Sublicensees, or Subcontractors, (d) BioCryst’s breach of any
of its representations, warranties, covenants, or obligations set forth in or
entered into pursuant to this Agreement, (e) the failure of BioCryst or any of
its Affiliates, licensees (not including Torii or its Affiliates, Sublicensees,
or Subcontractors), Sublicensees, or Subcontractors to abide by any Applicable
Law, or (f) any claim or demand from any employee or contractor of BioCryst or
its Affiliate who is an inventor of any Joint Technology with respect to the
ownership thereof, in each case of clauses (a) through (f) above, except to the
extent such Third Party Claims arise out of any of a Torii Indemnitee’s
negligence or willful misconduct, breach of this Agreement, or failure to abide
by any Applicable Law.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

11.3Indemnification Procedure. If either Party is seeking indemnification under
Section 11.1 (Indemnification; By Torii) or Section 11.2 (Indemnification; By
BioCryst) (the “Indemnified Party”), then it will inform the other Party (the
“Indemnifying Party”) of the Third Party Claim giving rise to such
indemnification obligations within [***] after receiving written notice of the
Third Party Claim (it being understood and agreed, however, that the failure or
delay by an Indemnified Party to give such notice of a Third Party Claim will
not affect the Indemnifying Party’s indemnification obligations hereunder except
to the extent the Indemnifying Party will have been actually and materially
prejudiced as a result of such failure or delay to give notice). The
Indemnifying Party will have the right to assume the defense of any such Third
Party Claim for which it is obligated to indemnify the Indemnified Party. The
Indemnified Party will cooperate with the Indemnifying Party and the
Indemnifying Party’s insurer as the Indemnifying Party may reasonably request,
and at the Indemnifying Party’s cost and expense. The Indemnified Party will
have the right to participate, at its own expense and with counsel of its
choice, in the defense of any Third Party that has been assumed by the
Indemnifying Party. Neither Party will have the obligation to indemnify the
other Party in connection with any settlement made without the Indemnifying
Party’s written consent, which consent will not be unreasonably withheld. The
Indemnifying Party will not admit liability of the Indemnified Party without the
Indemnified Party’s prior written consent, which consent will not be
unreasonably withheld. If the Parties cannot agree as to the application of
Section 11.1 (Indemnification; By Torii) or Section 11.2 (Indemnification; By
BioCryst) as to any Third Party Claim, pending resolution of the Dispute
pursuant to Article 14 (Dispute Resolution), then the Parties may conduct
separate defenses of such Third Party Claims, with each Party retaining the
right to claim indemnification from the other Party in accordance with
Section 11.1 (Indemnification; By Torii) or Section 11.2 (Indemnification; By
BioCryst), as applicable, upon resolution of the underlying Third Party Claim.

 

11.4Insurance. Torii will procure and maintain during the Term of this Agreement
and until the later of: (a) seven years after termination or expiration of this
Agreement, or (b) the date that all statues of limitation covering claims or
suits that may be instituted for personal injury based on the sale or use of a
Licensed Product have expired, commercial general liability insurance from a
minimum of “A-” AM Bests rated insurance company or insurer reasonably
acceptable to BioCryst, including product liability or clinical trials, if
applicable, with coverage limits of not less than [***] per occurrence and [***]
in the aggregate. BioCryst will procure and maintain during the conduct of any
Clinical Trial for the Licensed Product commercial general liability insurance
from a minimum of “A-” AM Bests rated insurance company or insurer, including
contractual liability and clinical trials, if applicable, with coverage limits
of not less than [***] per occurrence and [***] in the aggregate. Such insurance
policies will be primary and non-contributing with respect to any other similar
insurance policies available to such Party or its Affiliates. Any deductibles
for such insurance will be assumed by the Party procuring such insurance. Upon
written request, each Party will provide the other Party with evidence of such
insurance. If any such insurance is cancelled or materially changed, then the
insuring Party will provide written notice of such cancellation or change
promptly follow such insuring Party’s receipt thereof. Each Party will provide
the other Party with written notice at least [***] prior to the cancellation or
non-renewal of, or material changes in, such insurance. Such insurance will not
be construed to create a limit of either Party’s liability with respect to its
indemnification obligations under this Article 11 (Indemnification).

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

Article 12
INTELLECTUAL PROPERTY

 

12.1Inventions.

 

12.1.1Ownership. As between the Parties, (a) BioCryst will solely own all
BioCryst Technology and all Know-How developed or invented in the performance of
activities under this Agreement solely by BioCryst’s or its Affiliates’,
licensees’, Sublicensees’, or Subcontractors’ employees, agents, or independent
contractors, or any Persons contractually required to assign or license such
Know-How to BioCryst or any Affiliate of BioCryst and all Patent Rights that
Cover any such Know-How, but excluding Joint Technology, (b) Torii will solely
own all Torii Technology, including all Know-How developed or invented in the
performance of activities under this Agreement solely by Torii or its
Affiliates’, licensees’, Sublicensees’, or Subcontractors’ employees, agents, or
independent contractors, or any Persons contractually required to assign or
license such Know-How to Torii or any Affiliate of Torii and all Patent Rights
that Cover any such Know-How, but excluding Joint Technology, and (c) the
Parties will jointly own all Joint Technology. Subject only to the rights
expressly granted to the other Party under this Agreement, each Party, as
between such Party and the other Party, will own all rights, title, and
interests in and to any Know-How that is invented, conceived, discovered,
created, or otherwise developed by or on behalf of such Party (or its Affiliates
or its Sublicensees) under or in connection with this Agreement, whether or not
patented or patentable, and any and all Patent Rights and other intellectual
property rights with respect thereto. All determinations of inventorship under
this Agreement will be made in accordance with U.S. patent law.

 

12.1.2Disclosure. Torii will promptly disclose to BioCryst all Inventions that
it develops or invents in the performance of activities under this Agreement,
whether solely or jointly with others (in any event, prior to the filing of any
patent application with respect to such Inventions), including all invention
disclosures or other similar documents submitted to Torii by its or its
Affiliates’ employees, agents, or independent contractors relating thereto.
Torii will also promptly respond to reasonable requests from BioCryst for
additional information relating thereto.

 

12.1.3Practice Under and Other Use of Joint Technology. Subject to the rights
granted under and the restrictions set forth in this Agreement (including the
licenses granted under Article 2 (Licenses) and the restrictions set forth in
Section 2.6 (Exclusivity Covenant)), each Party will be entitled to the free use
and enjoyment of all Joint Technology and neither Party will have any obligation
to account to the other Party for profits, or to obtain any approval of the
other Party to license, assign, or otherwise exploit any Joint Technology by
reason of joint ownership thereof. Each Party hereby waives any right it may
have under the Applicable Law of any jurisdiction to require any such approval
or accounting. To the extent any further consent is required to enable a Party
to so license or exploit its interest in the Joint Technology, the other Party
will grant consent promptly upon request. Without limitation, each Party will
cooperate with the other Party if the Parties determine to apply for U.S. or
foreign patent protection for any Joint Technology and will obtain the
cooperation of the individual inventors of any such Joint Technology.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

12.2CREATE Act. Notwithstanding any provision to the contrary set forth in this
Agreement, Torii may not invoke the Cooperative Research and Technology
Enhancement Act, 35 U.S.C. § 102(c) (the “CREATE Act”) when exercising its
rights under this Agreement without the prior written approval of BioCryst. If
Torii intends to invoke the CREATE Act, then it will notify BioCryst and if
agreed by the Parties, then BioCryst will cooperate and coordinate its
activities with Torii with respect to any filings or other activities in support
thereof. The Parties acknowledge and agree that this Agreement is a “joint
research agreement” as defined in the CREATE Act.

 

12.3Senyo Jisshiken. BioCryst will reasonably support Torii in obtaining
registration under the name of Torii in the Territory of the exclusive license
granted to Torii to Commercialize the Licensed Product in the Field in the
Territory under this Agreement as a “Senyo Jisshiken” in accordance with Article
77 of the Japanese Patent Law promptly after the Regulatory Responsibility
Transfer Date with respect to BioCryst Patent Rights already issued or within
[***] after issuance or registration of the relevant BioCryst Patent Rights in
the Territory.

 

12.4Third Party In-Licenses.

 

12.4.1BioCryst Identified Rights. BioCryst will remain solely responsible for
the payment of all royalties, license fees, milestone payments, and other
payment obligations under all agreements relevant to the Licensed Product
entered into by BioCryst prior to the Effective Date. If, after the Effective
Date during the Term, BioCryst intends to obtain Control of any Know-How or
Patent Rights from a Third Party (whether by acquisition or license) that may be
necessary to Exploit a Licensed Product in the Field in or for the Territory
(other than through the Change of Control of BioCryst or as a result of the
acquisition by BioCryst of a Third Party by merger, acquisition, or similar
transaction or series of related transactions) (such Know-How and Patent Rights,
“BioCryst Identified Rights”), then BioCryst will notify Torii in writing of
such BioCryst Identified Rights and Section 12.4.3 (Third Party IP Agreements)
will apply.

 

12.4.2Torii Identified Rights. If Torii determines that a license under any
Know-How or Patent Rights controlled by a Third Party is necessary to
Commercialize the Licensed Product in the Field in the Territory (“Torii
Identified Rights”), then Torii will so notify BioCryst. BioCryst will have the
first right to acquire rights to any such Torii Identified Rights from such
Third Party (whether by acquisition or license) and if BioCryst intends to
acquire such rights, then BioCryst will notify Torii of such intention within
[***] after receipt of Torii’s written request to do so and the terms of
Section 12.4.3 (Third Party IP Agreements) will apply. If BioCryst notifies
Torii of its intention not to so acquire such rights within such [***] period,
or otherwise fails within [***] after the date of Torii’s written request to
acquire rights under such Torii Identified Rights, then, in each case, Torii
will have the right to acquire rights under such Torii Identified Rights from
such Third Party solely for the Field in the Territory. Torii will bear (and
will pay) [***] of the payments made to such Third Party in consideration for
the acquisition of rights under such Torii Identified Rights (whether by
acquisition or license).

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

12.4.3Third Party IP Agreements. Prior to BioCryst’s execution of an agreement
with a Third Party to acquire or license any BioCryst Identified Rights or Torii
Identified Rights (together, “BioCryst In-Licensed Rights” and any such
agreement, a “Third Party IP Agreement”), BioCryst will (a) provide Torii an
opportunity to review and comment on the terms of the proposed Third Party IP
Agreement that are applicable to Torii’s performance of any Torii Activities in
the Field in the Territory, including any payments that BioCryst would be
obligated to pay in connection with the grant, maintenance, or exercise of a
license or sublicense thereunder (as applicable) to Torii, (b) consider in good
faith incorporating Torii’s comments into such Third Party IP Agreement prior to
finalizing such agreement, and (c) ensure that such Third Party IP Agreement
includes the right to grant a sublicense to Torii in the Field in the Territory
under the applicable BioCryst In-Licensed Rights such that BioCryst Controls
such rights as BioCryst Know-How or BioCryst Patent Rights (as applicable). Upon
execution of such Third Party IP Agreement, BioCryst will notify Torii in
writing and will provide a description of the final terms thereof that are
material or are applicable to Torii’s performance of any Torii Activities in the
Field in the Territory, including payment terms pertaining to the grant,
maintenance, or exercise of a license or sublicense thereunder (as applicable)
to Torii. Without the prior written consent of Torii, BioCryst will not
terminate or amend any Third Party IP Agreement or fail to exercise its rights
or comply with its obligations under such Third Party IP Agreement if such
termination, amendment, or failure would adversely impact Commercialization of
the Licensed Product in the Field in the Territory.

 

12.4.4Responsibility for Costs. Following BioCryst’s execution of the applicable
Third Party IP Agreement, (a) such BioCryst In-Licensed Rights will be included
in the BioCryst Know-How or the BioCryst Patent Rights (as applicable) and
licensed or sublicensed (as applicable) to Torii under the licenses granted in
Section 2.1 (License Grants to Torii), subject to the terms of this Agreement
(including subject to Section 8.3.3(b) (Third Party Patent Rights and Know-How))
and the applicable Third Party IP Agreement, and (b) Torii will reimburse
BioCryst (i) [***] of any such payments under such Third Party IP Agreement that
solely pertain to, or arise solely as a result of, the Commercialization of the
Licensed Product in the Field in the Territory (for example, royalty payments
that are solely attributable to sales of Licensed Product in the Field in the
Territory or milestone payments payable upon achievement of events solely in the
Field in the Territory), and (ii) [***] of any upfront payments, milestone
payments, or similar payments payable in consideration for any BioCryst
In-Licensed Rights that pertain to, or arise as a result of, the Exploitation of
the Licensed Product both inside and outside of the Territory or inside and
outside the Field in the Territory, and that are non-Territory specific (for
example, an upfront payment to access technology or worldwide sales milestones);
provided that Torii may offset certain amounts in accordance with Section
8.3.3(b) (Third Party Patent Rights and Know-How).

 

12.5Know-How Transfer.

 

12.5.1As of the Effective Date. Within a reasonable period of time after the
Effective Date as agreed by the Parties, BioCryst will provide and transfer to
Torii copies of BioCryst Know-How that exists on the Effective Date, including
all study reports related to the Development of the Licensed Product in the
Field for the Territory, to the extent not previously provided to Torii and that
is necessary or reasonably useful for Torii to perform the Torii Activities for
the Licensed Product in the Field in the Territory in accordance with this
Agreement.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

12.5.2Other Know-How. Following the initial transfer of BioCryst Know-How as
provided in Section 12.5.1 (As of the Effective Date), BioCryst will provide
Torii with any additional BioCryst Know-How that is necessary or reasonably
useful to perform the Torii Activities for the Licensed Product in the Field in
the Territory in accordance with this Agreement that is developed by BioCryst or
its Affiliates or licensees since the previous annual disclosure, including
copies of all study reports related to the Development of the Licensed Product
in the Field for the Territory. Upon Torii’s reasonable request during the Term,
BioCryst will (a) make available to Torii all such BioCryst Know-How in
BioCryst’s possession and not previously provided to Torii hereunder and that is
necessary or reasonably useful to perform the Torii Activities for the Licensed
Product in the Field in the Territory in accordance with this Agreement, and (b)
transfer any such BioCryst Know-How to Torii no later than [***] after Torii’s
request therefor. Torii may only use the BioCryst Know-How to perform its
obligations or exercise its rights under this Agreement and in accordance with
the terms hereof. BioCryst may make such BioCryst Know-How available in any
reasonable form as BioCryst determines, including, if BioCryst so elects, in the
form such BioCryst Know-How is maintained by BioCryst. BioCryst will provide
consultation and assistance with qualified personnel in connection with the
technology transfer contemplated by this Section 12.5 (Know-How Transfer) as
reasonably requested by Torii, subject to personnel availability. Torii will be
responsible for any reasonable internal costs (at the FTE Rate) or external
expenses incurred by or on behalf of BioCryst to produce additional data or
analysis of the Licensed Product solely for the Field in the Territory and
BioCryst will be responsible for all other internal costs incurred in connection
with providing such assistance to Torii (to the extent reasonably requested).
Accordingly, BioCryst will invoice Torii for the foregoing costs and expenses
associated with the performance of such assistance as set forth under this
Section 12.5.2 (Other Know-How), and Torii will pay the undisputed invoiced
amounts within [***] after the date of the invoice.

 

12.5.3Data Exchange and Use. In addition to its adverse event and safety data
reporting obligations set forth in Section 3.6 (Adverse Events Reporting), Torii
will promptly provide to BioCryst, through the JSC, copies of any data and
results and all supporting documentation (e.g., protocols, investigator’s
brochures, case report forms, analysis plans, and all in English language)
Controlled by Torii that are generated by or on behalf of Torii or any of its
Controlled Affiliates, Sublicensees, or Subcontractors, if applicable, in
connection with the performance of any Torii Development Activities for each
Licensed Product. BioCryst and its designees will have the right to use and
reference such data and results provided by Torii for the purpose of obtaining,
supporting, or maintaining Regulatory Approval or any Reimbursement Approval, as
applicable, of any Licensed Product outside of the Territory or in the Territory
outside of the Field, without additional consideration.

 

12.6Patent Prosecution.

 

12.6.1BioCryst Patent Rights.

 

(a)Right to Prosecute. Subject to Section 12.6.3 (Joint Technology), as between
the Parties, BioCryst will have the right to control the Patent Prosecution of
all BioCryst Patent Rights throughout the world. Torii will be responsible for
[***] of all annual maintenance fees with respect to the BioCryst Patent Rights
in the Territory and BioCryst will bear [***] associated with the Patent
Prosecution of the BioCryst Patent Rights in the Territory. Torii will reimburse
BioCryst for such costs within [***] after receiving an invoice for such costs.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

(b)Review and Consult. BioCryst will consult with Torii and keep Torii
reasonably informed of the Patent Prosecution of the BioCryst Patent Rights in
the Territory and will provide Torii with material correspondence received from
any patent authority in the Territory in connection therewith. In addition,
BioCryst will provide Torii with drafts of proposed material filings in the
Field in the Territory and correspondence to any patent authority in the
Territory in connection with the Patent Prosecution of the BioCryst Patent
Rights in the Field in the Territory for Torii’s review and comment prior to the
submission of such proposed filings and correspondence. BioCryst will consider
Torii’s comments on Patent Prosecution in good faith and will incorporate such
comments where appropriate and BioCryst will take into consideration Torii’s
commercial strategy in the Field in the Territory relating to the Licensed
Product, but will have final decision-making authority under this
Section 12.6.1(b) (Review and Consult).

 

(c)Abandonment. If BioCryst decides that it is no longer interested in the
Patent Prosecution of a particular BioCryst Patent Right in the Territory during
the Term, then it will promptly provide written notice to Torii of such
decision. Torii may, upon written notice to BioCryst, assume the Patent
Prosecution of such Patent Right in BioCryst’s name at Torii’s sole cost and
expense. In such event, (i) Torii will be responsible for [***] of the costs and
expenses of the Patent Prosecution of such Patent Right, and (ii) BioCryst will
have the rights to review and consult set forth in Section 12.6.1(b) (Review and
Consult) mutatis mutandis.

 

(d)Schedule Updates. As soon as reasonably practicable following Torii’s
request, BioCryst will update Schedule 1.31 (BioCryst Patent Rights) or confirm
to Torii that there is no such update.

 

12.6.2Torii Patent Rights.

 

(a)Right to Prosecute. As between the Parties, Torii will have the right to
control the Patent Prosecution of all Torii Patent Rights throughout the world.
Torii will be responsible for [***] of the costs and expenses incurred with
respect to the Patent Prosecution of such Patent Rights throughout the world.
[***] incurred by or on behalf of Torii with respect to the Patent Prosecution
of such Patent Rights.

 

(b)Review and Consult. Torii will consult with BioCryst and keep BioCryst
reasonably informed of the Patent Prosecution of the Torii Patent Rights and
will provide BioCryst with all material correspondence received from any patent
authority in connection therewith. In addition, Torii will provide BioCryst with
drafts of all proposed material filings and correspondence to any patent
authority in connection with the Patent Prosecution of the Torii Patent Rights
for BioCryst’s review and comment prior to the submission of such proposed
filings and correspondence. Further, Torii will notify BioCryst of any decision
to cease Patent Prosecution of any Torii Patent Rights. Torii will consider
BioCryst’s comments on Patent Prosecution in good faith and will incorporate
such comments where appropriate and will take into consideration BioCryst’s
commercial strategy outside the Territory and in the Territory outside of the
Field, in each case, relating to the Licensed Product, but will have final
decision-making authority under this Section 12.6.2(b) (Review and Consult).

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

(c)Abandonment. If Torii decides that it is no longer interested in continuing
the Patent Prosecution of a particular Torii Patent Right during the Term, then
it will promptly provide written notice to BioCryst of such decision. BioCryst
may, upon written notice to Torii, assume such Patent Prosecution of such Torii
Patent Right in Torii’s name at BioCryst’s sole cost and expense. In such event,
(i) BioCryst will be responsible for [***] of the costs and expenses of the
Patent Prosecution of such Patent Right, and (ii) Torii will have the rights to
review and consult set forth in Section 12.6.2(b) (Review and Consult) mutatis
mutandis.

 

12.6.3Joint Technology.

 

(a)Right to Prosecute. [***] will control the Patent Prosecution of any Joint
Patent Rights both inside and outside of the Territory. [***] due with respect
to the Joint Patent Rights in the Territory and [***] will bear all other costs
associated with the Patent Prosecution of the Joint Patent Rights in the
Territory. [***] will reimburse [***] for such costs within [***] after
receiving an invoice with reasonable supporting documentation for such costs.
[***] will bear [***] of all costs associated with the Patent Prosecution of the
Joint Patent Rights outside of the Territory.

 

(b)Review and Consult. [***] will consult with [***] and keep [***] reasonably
informed of the Patent Prosecution of the Joint Patent Rights and will provide
[***] with all material correspondence received from any patent authority both
inside and outside the Territory in connection therewith. In addition, [***]
will provide [***] with drafts of all proposed material filings and
correspondence to any patent authority in its respective territory in connection
with the Patent Prosecution of the Joint Patent Rights for [***]’s review and
comment prior to the submission of such proposed filings and correspondence.
Further, [***] will notify [***] of any decision to cease Patent Prosecution of
any of the Joint Patent Rights. [***] will consider [***]’s comments on Patent
Prosecution in good faith and will incorporate such comments where appropriate
and will take into consideration [***]’s commercial strategy in the Territory
relating to the Licensed Product in the Field, but will have final
decision-making authority under this Section 12.6.3(b) (Review and Consult).

 

(c)Abandonment. If [***] decides that it is no longer interested in the Patent
Prosecution of a particular Joint Patent Right in the Territory, then it will
promptly provide written notice to [***] of such decision. Torii may, upon
written notice to [***], assume the Patent Prosecution of such Patent Right. In
such event, (i) [***] will be responsible for [***] of the costs and expenses
incurred with respect to the Patent Prosecution of such Patent Rights both
inside and outside the Territory, and (ii) [***] will retain the rights to
review and consult set forth in Section 12.6.3(b) (Review and Consult) mutatis
mutandis.

 

12.6.4Cooperation. Each Party will provide the other Party all reasonable
assistance and cooperation in the Patent Prosecution efforts under this
Section 12.6 (Patent Prosecution), including providing any necessary powers of
attorney and executing any other required documents or instruments for such
prosecution.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

12.7Patent Enforcement.

 

12.7.1Notice. Each Party will notify the other within [***] after becoming aware
of any alleged or threatened infringement by a Third Party product that is
competitive with any Licensed Product of any of the (a) BioCryst Patent Rights,
(b) Torii Patent Rights, or (c) Joint Patent Rights, and, in each case, any
related declaratory judgment, adversarial Patent Prosecution proceedings, or
equivalent action alleging the invalidity, unenforceability, or non-infringement
of such Patent Rights (collectively “Product Infringement”). The Party with the
first right to bring and control any legal action to enforce the BioCryst Patent
Rights, Torii Patent Rights, or other Joint Patent Rights, as applicable, under
this Section 12.7 (Patent Enforcement) will be referred to herein as the
“Controlling Party.”

 

12.7.2First Right and Step-In for Product Infringement.

 

(a)BioCryst First Right. BioCryst will have the first right to bring and
control, at its sole cost and expense, any legal action to enforce [***] against
any Product Infringement in the Field in Territory as it reasonably determines
appropriate, and BioCryst will consider in good faith the interests of Torii in
such enforcement of such [***].

 

(b)Torii First Right. Torii will have the first right to bring and control, at
its sole cost and expense, any legal action to enforce the [***] against any
Product Infringement in the Field in the Territory as it reasonably determines
appropriate, and Torii will consider in good faith the interests of BioCryst in
such enforcement of the [***].

  

(c)Step-In Rights. If the Controlling Party or its designee fails to abate the
applicable Product Infringement in the Territory or to file an action to abate
such Product Infringement in the Territory within three (3) months after a
written request from the other Party to do so, or if the Controlling Party
discontinues the prosecution of any such action after filing without abating
such infringement, then, in either case, the other Party will have the right to
enforce the applicable Patent Rights against such Product Infringement in the
Territory as it reasonably determines appropriate, which right will be limited
to Product Infringements in the Field if Torii is the non-Controlling Party;
provided that (i) the Controlling Party does not provide reasonable rationale
for not doing so or continuing to do so (including a substantive concern
regarding counter-claims by the infringing Third Party), and (ii) the other
Party will not enter into any settlement admitting the invalidity of, or
otherwise impairing, of any such Patent Rights without the prior written consent
of the Controlling Party.

  

12.7.3BioCryst Sole Right. BioCryst will have the sole right to bring and
control, at its sole cost and expense, any legal action to enforce BioCryst
Patent Rights or Joint Patent Rights against any Product Infringement outside of
the Territory or outside of the Field in Territory.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

12.7.4Cooperation. At the request of the Party bringing an action related to a
Product Infringement, the other Party will provide reasonable assistance in
connection therewith, including by executing reasonably appropriate documents,
cooperating in discovery, and joining as a party to the action if required by
Applicable Law to pursue such action.

 

12.7.5Recoveries. Any recoveries resulting from an enforcement action relating
to a claim of Product Infringement in the Territory will be first applied
against payment of each Party’s costs and expenses in connection therewith. Any
such recoveries in excess of such costs and expenses will be split, as follows:
(a) [***].

 

12.8Infringement of Third Party Rights.

 

12.8.1Notice. If any Licensed Product used or sold by Torii or its Affiliates or
Sublicensees becomes the subject of a Third Party’s claim or assertion of
infringement of a Patent Right or other rights in the Territory that are owned
or controlled by such Third Party, then Torii will promptly notify BioCryst
within [***] after receipt of such claim or assertion and will include in such
notice a copy of any summons or complaint (or the equivalent thereof) received
regarding the foregoing. Thereafter, the Parties will promptly meet to consider
the claim or assertion and the appropriate course of action and may, if
appropriate, agree on and enter into a “common interest agreement” wherein the
Parties agree to their shared, mutual interest in the outcome of such potential
dispute. To the extent applicable under Applicable Law in the relevant
jurisdiction, the Parties will assert and not waive the joint defense privilege
with respect to any communications between the Parties in connection with the
defense of such claim or assertion.

 

12.8.2Defense. Torii will be solely responsible for the defense of any such
infringement claims brought against Torii, at Torii’s cost and expense; provided
that Torii will not agree to any settlement, consent to judgment, or other
voluntary final disposition in connection with such defense action without
BioCryst’s prior written consent if such settlement, consent to judgment, or
other voluntary final disposition would (a) result in the admission of any
liability or fault on behalf of BioCryst, (b) result in or impose any payment
obligations upon BioCryst, or (c) subject BioCryst to an injunction or otherwise
limit BioCryst’s ability to take any actions or refrain from taking any actions
under this Agreement or with respect to any Licensed Product. Torii will keep
BioCryst informed on the status of such defense action, and BioCryst will have
the right, but not the obligation, to participate and be separately represented
in such defense action at its sole option and at its own expense. For the
avoidance of doubt, to the extent applicable, any damage payments paid by Torii
as a result of the final judgment or settlement of any such Third Party claim
will be subject to the terms of Section 12.4.2 (Torii Identified Rights) and
Section 8.3.3(b) (Third Party Patent Rights and Know-How).

 

12.9Patent Listings. With respect to patent listings in any patent listing
system established by any applicable Regulatory Authority in the Territory
during the Term that is similar to the FDA Orange Book, for issued patents for
any Licensed Product in the Field, the Parties will agree which patents to list
in such patent listing (a) prior to the submission of the first and any
subsequent MAA for such Licensed Product in the Field in the Territory to such
applicable Regulatory Authority, and (b) within [***] after the receipt of the
first and any subsequent Regulatory Approval in the Field in the Territory for
such Licensed Product from such Regulatory Authority.

 

12.10Patent Term Extensions. With respect to any system for extending the term
of Patent Rights in the Territory established by any applicable Regulatory
Authority during the Term that is similar to the patent term extension system in
the U.S., BioCryst will be solely responsible for making all decisions regarding
patent term extensions in the Territory, including supplementary protection
certificates and any other extensions that are now or become available in the
future, that are applicable to BioCryst Patent Rights or Joint Patent Rights
licensed hereunder and that become available directly as a result of the
Regulatory Approval of a Licensed Product in the Territory; provided that
BioCryst will consult with Torii with respect to such decisions and implement
the reasonable comments and concerns of BioCryst.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

12.11Patent Marking. Torii will mark all Licensed Product in accordance with the
applicable patent marking laws, and will require all of its Affiliates and
Sublicensees to do the same. To the extent permitted by Applicable Law, Torii
will indicate on the product packaging, advertisement and promotional materials
that such Licensed Product is in-licensed from BioCryst.

 

Article 13
TERM AND TERMINATION

 

13.1Term. Unless earlier terminated in accordance with Section 13.2
(Termination), this Agreement will be effective as of the Effective Date, and
will continue in effect until the expiration of the Transfer Price Payment Term
applicable to the Licensed Product (the “Term”).

 

13.2Termination.

 

13.2.1Termination Without Cause. Torii may terminate this Agreement in its
entirety for convenience and without cause only in the following circumstances:

 

(a)by providing written notice to BioCryst no later than [***] after Torii
receives from BioCryst the estimated internal costs (at the FTE Rate) and
external expenses to be incurred by or on behalf of BioCryst in the performance
of any Additional Development, which termination will be effective [***] after
receipt of such notice;

  

(b)Upon [***] prior written notice to BioCryst if the Licensed Product does not
receive the first Regulatory Approval in the Field in the Territory on or prior
to December 31, 2022; or

  

(c)Upon [***] prior written notice provided to BioCryst at any time after the
sixth (6th) anniversary of the First Commercial Sale of the first Licensed
Product in the Field in the Territory.

  

13.2.2Termination for Cause. If a Party materially breaches any of its material
obligations under this Agreement (a “Default”), then the non-Defaulting Party
may deliver notice of such Default to the other Party stating the cause and
proposed remedy (“Default Notification”). The Parties stipulate and agree that
(a) a material Default of Torii’s obligations set forth under Section 2.6
(Exclusivity Covenant) or (b) any default under Torii’s payment obligations set
forth under Article 8 (Payments), in each case ((a) and (b)), will be considered
a Default under this Agreement for purposes of this Section 13.2.2 (Termination
for Cause). For any Default arising from a failure to make a payment set forth
in this Agreement, the allegedly Defaulting Party will have [***] from the
receipt of the applicable Default Notice to cure such Default. For all Defaults
other than a failure to make a payment as set forth in this Agreement, the
allegedly Defaulting Party will have [***] from the date of the Default
Notification to cure such Default, provided that if such Default is not
reasonably capable of cure within such [***] period, but is capable of cure
within [***] from the date of such Default Notification, then the Defaulting
Party may submit, within [***] of such Default Notification, a reasonable cure
plan to remedy such Default as soon as possible and in any event prior to the
end of such [***] period that is reasonably acceptable to the non-Defaulting
Party, and, upon such submission, the [***] cure period will be automatically
extended for so long as the Defaulting Party continues to use reasonable efforts
to cure such Default in accordance with the cure plan, but for no more than
[***]. If the Party receiving notice of Default fails to cure that Default
within the applicable period set forth above, then the Party originally
delivering the Default Notification may terminate this Agreement effective upon
written notice of termination to the other Party.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

13.2.3Failure to Achieve Performance Targets.

 

(a)Termination Right. During the [***] Launch Years (the “Performance Target
Period”), if Torii fails to meet the Performance Targets for any such Launch
Year (other than as a result of BioCryst’s failure to supply a sufficient
quantity of Licensed Product to meet the market demand therefor in the Field in
the Territory) (the “First Failed Year”), then Torii may submit a remediation
plan that is reasonably acceptable to BioCryst to achieve the Performance
Targets for the upcoming Launch Year. If Torii either does not submit such a
remediation plan or does submit such a remediation plan but again fails to so
meet the Performance Targets for the next Launch Year after the First Failed
Year (other than as a result of BioCryst’s failure to supply a sufficient
quantity of Licensed Product to meet the market demand therefor in the Field in
the Territory) (the “Second Failed Year”), then BioCryst may provide a written
notice to Torii that indicates that BioCryst will terminate the Agreement unless
[***].

  

(b)Sole and Exclusive Remedy. This Section 13.2.3 (Failure to Achieve
Performance Targets) sets forth BioCryst’s sole and exclusive remedy in the
event Torii fails to achieve a Performance Target during the Performance Target
Period. For clarity, any failure by Torii to achieve a Performance Target
following the Performance Target Period will not give BioCryst the right to
terminate the Agreement.

  

13.2.4Termination for Patent Challenge. Except to the extent unenforceable under
Applicable Law, BioCryst may terminate this Agreement by providing written
notice of termination to Torii if Torii or its Affiliates or Sublicensees
(individually or in association with any Person) contests or assists a Third
Party in contesting the scope, validity, or enforceability of any BioCryst
Patent Right or Joint Patent Right anywhere in the world in any court, tribunal,
arbitration proceeding, or other proceeding, including the U.S. Patent and
Trademark Office and the U.S. International Trade Commission (a “Patent
Challenge”). In the event of such a Patent Challenge, BioCryst will provide
prompt written notice of such Patent Challenge to Torii, and BioCryst may
terminate this Agreement by providing written notice of such termination to
Torii. If BioCryst believes based on the advice of counsel that termination of
this Agreement pursuant to this Section 13.2.4 (Termination for Patent
Challenge) is not an available remedy under Applicable Law, then in lieu of such
termination BioCryst may instead increase the amount of all Milestone Payments
and Transfer Price Payments payable under this Agreement by [***] by providing
written notice of such election to Torii. As used herein, a Patent Challenge
includes: (a) filing an action under 28 U.S.C. §§ 2201-2202 seeking a
declaration of invalidity or unenforceability of any such Patent Right; (b)
filing, or joining in, a petition under 35 U.S.C. § 311 to institute inter
partes review of any such Patent Right; (c) filing, or joining in, a petition
under 35 U.S.C. § 321 to institute post-grant review of any such Patent Right or
any portion thereof; (d) filing or commencing any opposition, nullity, or
similar proceedings challenging the validity of any such Patent Right in any
country or region; or (e) any foreign equivalent of clauses (a), (b), (c), or
(d), including under Applicable Law in Japan.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

13.2.5Cessation of Commercialization. Without limiting BioCryst’s termination
remedies under Section 13.2.2 (Termination for Cause), if following the
Performance Target Period but during the Transfer Price Payment Term Torii and
its Affiliates do not conduct any material marketing activities with respect to
the Licensed Product in the Field in the Territory for a continuous period of
longer than [***], and such suspension of activity is not: (a) contemplated in a
written agreement of the Parties, (b) a result of Torii’s reasonable response to
guidance from or action by a Regulatory Authority in the Territory (such as a
clinical hold, or a recall or withdrawal), (c) due to BioCryst’s failure to
supply such Licensed Product in accordance with the terms of the Supply
Agreement, or (d) prevented throughout such period by a force majeure for which
Torii provided notice pursuant to Section 15.8 (Force Majeure) and that
persisted throughout such period despite Torii’s compliance with the terms of
Section 15.8 (Force Majeure), then BioCryst may, at its election, terminate this
Agreement in its entirety upon [***] prior written notice to Torii.

 

13.2.6Termination for Bankruptcy. To the extent permitted under applicable laws,
if at any time during the Term, an Event of Bankruptcy (as defined below)
relating to either Party (the “Bankrupt Party”) occurs, the other Party will
have, in addition to all other legal and equitable rights and remedies available
hereunder, the option to terminate this Agreement upon [***] written notice to
the Bankrupt Party. It is agreed and understood that if the other Party does not
elect to terminate this Agreement upon the occurrence of an Event of Bankruptcy,
except as may otherwise be agreed with the trustee or receiver appointed to
manage the affairs of the Bankrupt Party, the other Party will continue to make
all payments required of it under this Agreement as if the Event of Bankruptcy
had not occurred, then the Bankrupt Party will not have the right to terminate
any license granted herein. The term “Event of Bankruptcy” means: (a) filing in
any court or agency pursuant to any statute or regulation of any state or
country, a petition in bankruptcy or insolvency or for reorganization or for an
arrangement or for the appointment of a receiver or trustee of the Bankrupt
Party or of its assets or (b) being served with an involuntary petition against
the Bankrupt Party, filed in any insolvency proceeding, and such petition will
not be dismissed within [***] after the filing thereof. Without limitation, the
Bankrupt Party’s rights under this Agreement will include those rights afforded
by 11 U.S.C. §365(n) of the United States Bankruptcy Code (the “Bankruptcy
Code”) and any successor thereto. If the bankruptcy trustee of a Bankrupt Party
as a debtor or debtor-in-possession rejects this Agreement under 11 U.S.C.
§365(o) of the Bankruptcy Code, then the other Party may elect to retain its
rights licensed from the Bankrupt Party hereunder (and any other supplementary
agreements hereto) for the duration of this Agreement and avail itself of all
rights and remedies to the full extent contemplated by this Agreement and 11
U.S.C. §365(n) of the Bankruptcy Code, and any other Applicable Law.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

13.2.7Full Force and Effect During Notice Period. This Agreement will remain in
full force and effect until the expiration of the applicable termination notice
period. For clarity, if Torii or any of its Affiliates or Sublicensees achieve
any Milestone Events during the termination notice period, then the
corresponding Milestone Payment is accrued and Torii will remain responsible for
the payment of such Milestone Payment even if the due date of such Milestone
Payment occur after the effective date of the termination.

 

13.3Effect of Expiration. Following expiration (but not termination) of the
Term, the license granted to Torii in Section 2.1 (License Grants to Torii) will
become non-exclusive, fully-paid, irrevocable and perpetual, and the covenant in
Section 2.1.3 (Covenant Not to Practice) will terminate and cease to apply.
Reasonably prior to the anticipated expiration of the Term, upon Torii’s
reasonable request, BioCryst will make necessary arrangements, including, to
reasonably cooperate with Torii to engage one or more CMO(s) engaged by BioCryst
to Manufacture the Compound or the Licensed Product for Commercialization
purposes in the Field in the Territory, or to transfer to Torii or one or more
CMOs in the Territory selected and engaged by Torii to Manufacture the Compound
or the Licensed Product in the Field for the Territory copies of the BioCryst
Manufacturing Know-How in electronic form or such other form maintained by
BioCryst so as to enable Torii to Manufacture or have the Licensed Product
Manufactured for itself following expiration of the Term. Torii will be
responsible for all reasonable internal costs (at the FTE Rate) and external
expenses incurred by BioCryst in connection with such transfer of Know-How.
Accordingly, BioCryst may invoice Torii for such costs and expenses, and Torii
will pay the undisputed invoiced amounts within [***] after the date of the
invoice.

 

13.4Effect of Termination. Upon the termination (but not expiration) of this
Agreement:

 

13.4.1Licenses. As of the effective date of termination of this Agreement,
except as expressly set forth in this Agreement, all licenses and all other
rights granted by BioCryst to Torii under the BioCryst Technology for the
Licensed Product will terminate and all sublicenses granted and Subcontractors
engaged by Torii pursuant to Section 2.2 (Sublicensing and Subcontractors) with
respect to the Licensed Product will also terminate. Each Party will retain its
joint ownership interests in the Joint Technology. In addition, upon the
termination of this Agreement for any reason other than for termination by Torii
pursuant to Section 13.2.2 (Termination for Cause) BioCryst will have, and Torii
hereby grants to BioCryst, effective upon such termination, a worldwide,
exclusive, fully-paid, royalty-free, perpetual, irrevocable, and sublicenseable
(through multiple tiers) license under the Torii Technology Controlled by Torii
as of the effective date of such termination, in each case, solely to Exploit
the Licensed Product.

 

13.4.2Assignment of Product Trademarks. Torii will assign to BioCryst its entire
rights, title, and interest in any Product Marks for the Licensed Product.

 

13.4.3Assignment of Agreements. Torii will assign to BioCryst any Third Party IP
Agreement pursuant to which Torii then Controls any Torii Identified Rights, if
permitted under such Third Party IP Agreement (and will use reasonable efforts
to seek any consent required from the applicable Third Party in connection with
such an assignment). If such Third Party IP Agreement cannot be assigned to
BioCryst, then upon BioCryst’s reasonable request, Torii will maintain such
Third Party IP Agreement and BioCryst will pay to Torii [***] of all payments
due to the applicable Third Party under any such Third Party IP Agreement in
consideration of the sublicense to BioCryst and BioCryst’s Exploitation of such
Torii Identified Rights. If Torii is unable to sublicense any Torii Identified
Rights to BioCryst pursuant to this Section 13.4.1 (Effect of Termination;
Licenses) without the consent of the Third Party, then Torii undertakes, on
request from BioCryst, to use reasonable efforts to procure such licenses with
respect to the Licensed Product on behalf of BioCryst to the extent that it is
able to do so, and BioCryst will pay such fees and agree to be bound by the
terms agreed between Torii and the Third Party licensor.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

13.4.4Regulatory Submissions and Regulatory Approvals. Torii will and hereby
does, and will cause its Affiliates and Sublicensees to, (a) no later than [***]
after the effective date of termination of this Agreement, assign and transfer
to BioCryst or its designee all of Torii’s rights, title, and interests in and
to all Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals
for the Licensed Product then owned or Controlled by Torii or any of its
Affiliates or Sublicensees, and (b) to the extent assignment pursuant to clause
(a) is delayed or is not permitted by the applicable Regulatory Authority,
permit BioCryst to cross-reference and rely upon any Regulatory Submissions,
Regulatory Approvals, and Reimbursement Approvals filed by Torii with respect to
such Licensed Product. Torii will execute and deliver, or will cause to be
executed and delivered, to BioCryst or its designee such endorsements,
assignments, commitments, acknowledgements, and other documents as may be
necessary to assign, convey, transfer, and deliver to BioCryst or its designee
all of Torii’s or its applicable Affiliate’s or designee’s rights, title, and
interests in and to all such assigned Regulatory Submissions, Regulatory
Approvals, and Reimbursement Approvals to BioCryst, including submitting to each
applicable Regulatory Authority or other Governmental Authority in the Territory
a letter or other necessary documentation (with copy to BioCryst) notifying such
Regulatory Authority or other Governmental Authority of, or otherwise giving
effect to, the transfer of ownership to BioCryst of all such assigned Regulatory
Submissions, Regulatory Approvals, and Reimbursement Approvals. In addition,
upon BioCryst’s written request, Torii will, at its cost and expense, provide to
BioCryst copies of all material related documentation, including material
non-clinical, preclinical, and clinical data related to the Licensed Product
that are held by or reasonably available to Torii or its Affiliates or
Sublicensees. The Parties will discuss and establish appropriate arrangements
with respect to safety data exchange, including with respect to any amendments
to the SDE Agreement, provided that BioCryst will assume all safety and safety
database activities with respect to the Licensed Product no later than 60 days
after the effective date of termination of this Agreement.

 

13.4.5Appointment as Exclusive Distributor. If Torii is Commercializing any
Licensed Product in the Territory as of the effective date of termination, then,
at BioCryst’s election (in its sole discretion) in the Territory, until such
time as all Regulatory Approvals and Reimbursement Approvals with respect to
such Licensed Product in the Territory have been assigned and transferred to
BioCryst or its designee, either (a) Torii will appoint BioCryst or its designee
as its exclusive distributor of such Licensed Product in the Territory and grant
BioCryst or its designee the right to appoint sub-distributors, to the extent
not prohibited by any written agreement between Torii or any of its Affiliates
and a Third Party; provided that BioCryst will purchase any and all salable
inventory of the Licensed Product held by Torii or its Affiliates as of the
effective date of termination with respect to such Licensed Product at a price
equal to BioCryst’s Manufacturing costs for such Licensed Product, or (b) Torii
will have the continued right to sell the Licensed Product in the Territory from
its inventory; provided, however, that in the case of clause (b) Torii’s
obligations under this Agreement with respect to the Licensed Product that Torii
sells, including the obligation to remit Transfer Price Payments to BioCryst
hereunder, will continue in full force and effect during such period.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

13.4.6Assignment and Disclosure. To the extent requested by BioCryst following
the date that a Party provides notice of termination of this Agreement, Torii
will promptly upon request (and in any event within [***] after the effective
date of termination):

 

(a)assign and transfer to BioCryst or its designee all of Torii’s rights, title,
and interests in and to all clinical trial agreements (if any) and distribution
agreements (to the extent assignable and not cancelled), confidentiality and
other agreements, data and other Know-How (including commercial information) in
Torii’s Control, in each case, relating to the Licensed Product and that are
necessary or reasonably useful for the Exploitation of the Licensed Product;

 

(b)assign or amend, as appropriate, any agreements or arrangements with Third
Party vendors (including distributors) with respect to the Licensed Product or,
to the extent any such Third Party agreement or arrangement is not assignable to
BioCryst, reasonably cooperating with BioCryst to arrange to continue to provide
such services for a reasonable time after termination of this Agreement with
respect to such Licensed Product to facilitate the orderly transition of all
Commercialization and other activities then being performed by or on behalf of
Torii or its Affiliates or Sublicensees for the Licensed Product to BioCryst or
its designee;

 

(c)disclose to BioCryst or its designee all documents, records, and materials
related to the Licensed Product that are Controlled by Torii or its Affiliates
or Sublicensees or that Torii is able to obtain using reasonable efforts, and
that embody the foregoing; and

 

(d)assign and transfer to BioCryst or its designee all of Torii’s rights, title,
and interests in and to any Promotional Materials, training materials, medical
education materials, packaging and labeling, and all other literature or other
information related to the Licensed Product and copyrights and any registrations
for the foregoing.

 

Unless this Agreement is terminated by Torii pursuant to Section 13.2.2
(Termination for Cause) or Section 13.2.6 (Termination for Bankruptcy), Torii
will bear the costs and expenses associated with the assignments set forth in
this Section 13.4.6 (Assignment and Disclosure). If this Agreement is terminated
by Torii pursuant to Section 13.2.2 (Termination for Cause), then BioCryst will
reimburse Torii for the costs and expenses associated with the assignments set
forth in this Section 13.4.6 (Assignment and Disclosure). To the extent that any
agreement or other asset described in this Section 13.4.6 (Assignment and
Disclosure) is not assignable by Torii, then such agreement or other asset will
not be assigned, and, upon the request of BioCryst, Torii will take such steps
as may be necessary to allow BioCryst to obtain and to enjoy the benefits of
such agreement or other asset, without additional payment therefor, in the form
of a license or other right to the extent Torii has the right and ability to do
so, and in the event this Agreement is terminated by Torii pursuant to
Section 13.2.2 (Termination for Cause), BioCryst will reimburse Torii for its
costs and expenses incurred in doing so. For clarity, BioCryst will have the
right to request that Torii take any or all of the foregoing actions in whole or
in part, or with respect to all or any portion of the assets set forth in this
Section 13.4.6 (Assignment and Disclosure).

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

13.4.7Regulatory Transfer Support. In furtherance of the assignment of
Regulatory Submissions, Regulatory Approvals, and Reimbursement Approvals and
other data pursuant to Section 13.4.4 (Regulatory Submissions and Regulatory
Approvals) and Section 13.4.6 (Assignment and Disclosure), Torii will appoint
BioCryst as Torii’s or its Affiliate’s agent for all Licensed Product-related
matters involving Regulatory Authorities until all Regulatory Submissions,
Regulatory Approvals, Reimbursement Approvals, and other governmental or
regulatory filings that are not then in BioCryst’s or its Affiliate’s name have
been assigned to BioCryst or its designee. In the event of failure to obtain
such assignment, Torii hereby consents and grants to BioCryst the right to
access and reference (without any further action required on the part of Torii,
whose authorization to file this consent with any Regulatory Authority is hereby
granted) any such item with respect to the Licensed Product.

 

13.4.8Know-How Transfer Support. In furtherance of the assignment of Know-How
pursuant to Section 13.4.6 (Assignment and Disclosure), Torii will, for a period
of twelve (12) months from the effective date of termination of this Agreement,
provide such consultation or other assistance as BioCryst may reasonably request
to assist BioCryst in becoming familiar with such Know-How in order for BioCryst
to undertake further Exploitation of the Licensed Product, at BioCryst’s cost
and expense; provided that if the Agreement is terminated by Torii for any
reason other than pursuant to Section 13.2.2 (Termination for Cause) for Default
by BioCryst, then Torii will provide the first [***] of Torii services dedicated
to such assistance free of charge.

 

13.4.9Inventory. At BioCryst’s election and request, Torii will transfer to
BioCryst or its designee some or all inventory of the Licensed Product
(including all final product, bulk drug substance, intermediates,
works-in-process, formulation materials, reference standards, drug product
clinical reserve samples, packaged retention samples, and the like) then in the
possession or Control of Torii, its Affiliates or Sublicensees; provided that
BioCryst will pay Torii a price equal to BioCryst’s Manufacturing costs for such
Licensed Product.

 

13.4.10Wind Down and Transition. Torii will be responsible, at its own cost and
expense (subject to Section 13.4.13 (Termination by Torii for Cause)), for the
wind-down of Torii’s and its Affiliates’ and its Sublicensees’ activities with
respect to the Licensed Product. Torii will, and will cause its Affiliates and
Sublicensees to, reasonably cooperate with BioCryst to facilitate orderly
transition of all Commercialization and other activities then being performed by
or on behalf of Torii or its Affiliates or Sublicensees for the Licensed Product
to BioCryst or its designee, including reasonably cooperating with BioCryst to
transfer all Commercialization and other activities to BioCryst or its designee
and continuing to perform such activities on BioCryst’s behalf for a reasonable
time after termination of this Agreement with respect to such Licensed Product
until such transfer is completed.

 

13.4.11Return of Confidential Information. At the Disclosing Party’s election,
the Receiving Party will return (at Disclosing Party’s expense) or destroy all
tangible materials comprising, bearing, or containing any Confidential
Information of the Disclosing Party relating to the Licensed Product that are in
the Receiving Party’s or its Affiliates’ or Sublicensees’ possession or control
and provide written certification of such destruction (except to the extent any
information is the Confidential Information of both Parties or to the extent
that the Receiving Party has the continuing right to use the Confidential
Information under this Agreement); provided that the Receiving Party may retain
one copy of such Confidential Information for its legal archives.
Notwithstanding any provision to the contrary set forth in this Agreement, the
Receiving Party will not be required to destroy electronic files containing such
Confidential Information that are made in the ordinary course of its business
information back-up procedures pursuant to its electronic record retention and
destruction practices that apply to its own general electronic files and
information.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

13.4.12Further Assistance. Torii will provide any other assistance or take any
other actions, in each case, reasonably requested by BioCryst as necessary to
transfer to BioCryst all Exploitation of the Licensed Product, and will execute
all documents as may be reasonably requested by BioCryst in order to give effect
to this Section 13.4 (Effect of Termination).

 

13.4.13Termination by Torii for Cause. Notwithstanding any provision to the
contrary in this Article 13 (Term and Termination), if Torii terminates this
Agreement pursuant to Section 13.2.2 (Termination for Cause), then BioCryst will
be responsible for the reasonable, documented out-of-pocket costs incurred by
Torii directly in connection with the performance of the activities set forth in
this Section 13.4 (Effects of Termination). Torii will invoice BioCryst
quarterly for the foregoing costs incurred by or on behalf of Torii in such
Calendar Quarter, and BioCryst will pay the undisputed invoiced amounts within
[***] after the date of any such invoice.

 

13.5Survival. Expiration or termination of this Agreement will not relieve the
Parties of any obligation accruing prior to such expiration or termination.
Without limiting the foregoing, the following provisions of this Agreement will
survive the expiration or termination of this Agreement: Article 1
(Definitions), Section 2.3 (License Grants to BioCryst), Section 8.3.4 (Transfer
Price Payment Reports and Payments) (with respect to payments becoming due
during the Term), Section 8.5 (Other Amounts Payable) (with respect to amounts
becoming due during the Term), Section 8.8 (Currency; Exchange Rate) (with
respect to amounts becoming due during the Term), 8.9 (Blocked Payments) (with
respect to amounts becoming due during the Term), 8.10 (Late Payments) (with
respect to amounts becoming due during the Term), Section 8.11 (Financial
Records and Audits), (with respect to payments becoming due during the Term),
Section 9.1 (Duty of Confidence), Section 9.2 (Confidential Information),
Section 9.3 (Exemptions), Section 9.4 (Authorized Disclosures), Section 9.6
(Publications), Section 9.8 (Attorney-Client Privilege), Section 10.4 (Covenant
Not to Sue), Article 11 (Indemnification), Section 12.1.1 (Ownership), Section
12.1.3 (Practice Under and Other Use of Joint Technology). Section 12.6.3 (Joint
Technology), Section 12.6.4 (Cooperation), Section 13.1 (Term), Section 13.3
(Effect of Expiration), Section 13.4 (Effect of Termination), Section 13.5
(Survival), Section 13.6 (Termination Not Sole Remedy), Article 14 (Dispute
Resolution), and Article 15 (Miscellaneous).

 

13.6Termination Not Sole Remedy. Except as expressly provided in Section 13.2.3
(Failure to Achieve Performance Targets), termination is not the sole remedy
under this Agreement and, whether or not termination is effected and
notwithstanding anything to the contrary set forth in this Agreement, all other
remedies will remain available except as expressly set forth herein.

 

Article 14
DISPUTE RESOLUTION

 

14.1General. The Parties recognize that a dispute may arise relating to this
Agreement, including matters that may involve the Affiliates of any Party (a
“Dispute”). Except as otherwise expressly set forth in this Agreement, any
Dispute other than matters subject to resolution under Article 7 (Governance),
will be resolved in accordance with this Article 14 (Dispute Resolution).

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

14.2Negotiation; Escalation. The Parties will negotiate in good faith and use
reasonable efforts to settle any Dispute under this Agreement. Any Dispute as to
the breach, enforcement, interpretation, or validity of this Agreement will be
referred to the Executive Officers for attempted resolution. If the Executive
Officers are unable to resolve such Dispute within [***] after such Dispute is
referred to them, then, upon the written request of either Party to the other
Party, other than a Dispute relating to the scope, validity, enforceability, or
infringement of any Patent Rights or trademark rights (which will be submitted
for resolution to a court of competent jurisdiction in the country or region in
which such Patent Rights or trademark rights were granted or arose), the Dispute
will be subject to arbitration process in accordance with Section 14.3
(Arbitration).

 

14.3Arbitration. Any unresolved Dispute that was subject to Section 14.2
(Negotiation; Escalation) will be finally settled by arbitration without the
right to appeal, in New York City, before a panel of three arbitrators under the
procedural rules of the International Chamber of Commerce (“ICC Rules”). Each
Party will nominate an arbitrator, and the Party-nominated arbitrators will
agree upon the third (3rd) arbitrator who will be the chair of the arbitrate
tribunal. If the two (2) Party-nominated arbitrators are unable to agree upon
the chair, then the chair will be selected as provided in the ICC Rules. The
arbitration award will be binding upon the Parties and enforceable by any court
of competent jurisdiction. The arbitration award will include an award as to
costs including attorney fees. These provisions will not prevent a Party from
making application to any court of competent jurisdiction seeking equitable
relief.

 

14.4Injunctive Relief. Notwithstanding any provision to the contrary set forth
in this Agreement, in the event of an actual or threatened breach hereunder, the
aggrieved Party may seek equitable relief (including restraining orders,
specific performance or other injunctive relief) in any court or other forum,
without first submitting to the dispute resolution procedures set forth in
Section 14.2 (Negotiation; Escalation).

 

14.5Confidentiality. Any and all activities conducted under this Article 14
(Dispute Resolution), including any and all non-public proceedings and decisions
under Section 14.3 (Arbitration), will be the Confidential Information of each
of the Parties, and will be subject to the terms of Article 9 (Confidentiality;
Publication).

 

14.6Tolling. The Parties agree that all applicable statutes of limitation and
time-based defenses (such as estoppel and laches) will be tolled once the
dispute resolution procedures set forth in this Article 14 (Dispute Resolution)
have been initiated and for so long as they are pending.

 

Article 15
MISCELLANEOUS

 

15.1Operation Adjustments for [***]. The Parties recognize that it may be
necessary to make technical amendments to this Agreement and to enter into
agreements or other arrangements with Third Parties to reflect the operational
conditions that will be necessitated by the fact that until the Regulatory
Responsibility Transfer Date a Third Party will hold the Regulatory Approval for
the Licensed Product in the Territory on behalf of BioCryst and such Third Party
will purchase from BioCryst and import Licensed Product for resale to Torii (as
opposed to Torii holding the Regulatory Approval and BioCryst selling Licensed
Product directly to Torii, which will be the case from and after the Regulatory
Responsibility Transfer Date). The Parties will enter into all such amendments
and agreements or other arrangements with Third Parties as necessary to preserve
the intent and practical and economic effect of this Agreement to the greatest
extent possible.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

15.2Assignment. This Agreement may not be assigned or otherwise transferred, nor
may any right or obligation hereunder be assigned or transferred, by either
Party without the prior written consent of the other Party. Notwithstanding any
provision to the contrary set forth in this Agreement, BioCryst may assign its
rights to receive payments under this Agreement to one or more Persons without
consent of Torii (including as part of a royalty factoring transaction), and
either Party may, without consent of the other Party, assign this Agreement and
its rights and obligations hereunder (a) in whole or in part to an Affiliate of
such Party, or (b) in whole to its successor-in-interest in connection with the
sale of all or substantially all of its assets to which this Agreement relates,
whether in a merger, acquisition, or similar transaction or series of related
transactions; provided that in the case of the foregoing clause (a) or (b), the
assigning Party provides written notice of such assignment to the non-assigning
Party within [***] after the effective date of such assignment. Any attempted
assignment of this Agreement not in accordance with this Section 15.2
(Assignment) will be null, void, and of no legal effect. The terms of this
Agreement will be binding upon, and will inure to the benefit of, the Parties
and their respected successors and permitted assigns.

 

15.3LIMITATION OF LIABILITY. NEITHER PARTY WILL BE LIABLE TO THE OTHER FOR ANY
SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM
OR RELATING TO ANY BREACH OF THIS AGREEMENT, OR DAMAGES FOR LOSS OF PROFIT IN
CONNECTION WITH THIS AGREEMENT, IN EACH CASE, REGARDLESS OF ANY NOTICE OF THE
POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS
SECTION 15.3 (LIMITATION OF LIABILITY) IS INTENDED TO OR WILL LIMIT OR RESTRICT
THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 11.1
(INDEMNIFICATION; BY TORII) OR SECTION 11.2 (INDEMNIFICATION; BY BIOCRYST), OR
DAMAGES AVAILABLE TO A PARTY FOR THE OTHER PARTY’S BREACH OF ITS OBLIGATIONS
HEREUNDER RELATING TO Article 8 (PAYMENTS), MISAPPROPRIATION OR INFRINGEMENT OF
INTELLECTUAL PROPERTY OWNED OR CONTROLLED BY SUCH PARTY, TORII’S BREACH OF ITS
OBLIGATIONS UNDER SECTION 2.6 (EXCLUSIVITY COVENANT) OR THE LICENSES GRANTED TO
TORII UNDER THIS AGREEMENT, OR EITHER PARTY’S BREACH OF Article 9
(CONFIDENTIALITY; PUBLICATION).

 

15.4Section 365(n) of the Bankruptcy Code. All rights and licenses granted under
or pursuant to this Agreement by a Party to the other, including those set forth
in Section 2.1 (License Grants to Torii) and Section 2.3 (License Grants to
BioCryst), are and will otherwise be deemed to be, for purposes of Section
365(n) of the U.S. Bankruptcy Code or any foreign counterpart thereto, licenses
of right to “intellectual property” as defined under Section 101 of the U.S.
Bankruptcy Code or any foreign counterpart thereto. The Parties agree that the
Parties will retain and may fully exercise all of their rights and elections
under the U.S. Bankruptcy Code and any foreign counterpart thereto. All payments
to be made by Torii under this Agreement or any ancillary agreement (such as any
supply agreement), including the Upfront Payment, Milestone Payments and
Transfer Price Payments, will be considered “royalties” for purposes of Section
365(n) of the U.S. Bankruptcy Code.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

15.5Severability. If any one or more of the provisions contained in this
Agreement is held invalid, illegal or unenforceable in any respect, the
validity, legality, and enforceability of the remaining provisions contained
herein will not in any way be affected or impaired thereby, then unless the
absence of the invalidated provisions adversely affects the substantive rights
of the Parties. The Parties will in such an instance use their best efforts to
replace the invalid, illegal or unenforceable provisions with valid, legal, and
enforceable provisions that, insofar as practical, implement the purposes of
this Agreement.

 

15.6Notices. All notices that are required or permitted hereunder will be in
writing, and will specifically refer to this Agreement, will be addressed to the
appropriate Party at the address specified below or such other address as may be
specified by such Party in writing in accordance with this Section 15.6
(Notices) (with a courtesy copy sent by email, which will not constitute
notice), and will be deemed to have been given for all purposes (a) when
received, if hand-delivered or a dispatched through a reputable courier service,
or (b) seven (7) days after mailing, if mailed by first class certified or
registered airmail, postage prepaid, return receipt requested.

 

If to BioCryst:

 

BioCryst Pharmaceuticals, Inc.

4505 Emperor Blvd, Suite 200

Durham, NC 27703, USA

Attention: Chief Executive Officer

 

with a copy to:

 

BioCryst Pharmaceuticals, Inc.

4505 Emperor Blvd, Suite 200

Durham, NC 27703, USA

Attention: General Counsel

Email: [***]

 

with a copy to (which will not constitute notice):

Ropes & Gray LLP

800 Boylston Street; Prudential Tower

Boston, MA 02199

Attention: [***]

Email: [***]

 

If to Torii:

Torii Pharmaceutical Co., Ltd.

Torii Nihonbashi Bldg.,

4-1, Nihonbashi-Honcho 3-chome,

Chuo-ku, Tokyo 103-8439, Japan

Attention: Vice President, Business Development Dept.

 

with a copy to (which will not constitute notice):

 

 

Jones Day 

Kamiya-cho prime place, 

1-17, Toranomon 4-chome, 

Minato-ku, Tokyo 105-0001, Japan 

Attention: [***] 

Email: [***]

 

15.7Governing Law. This Agreement, and all claims or causes of action (whether
in contract, tort or statute) that may be based upon, arise out of or relate to
this Agreement, or the negotiation, execution or performance of this Agreement
or the breach thereof (including any claim or cause of action based upon,
arising out of or related to any representation or warranty made in or in
connection with this Agreement or as an inducement to enter into this
Agreement), will be governed by, and enforced in accordance with, the internal
laws of the State of New York, including its statutes of limitations without
giving effect to the conflicts of law provisions thereunder.

 

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Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

15.8Force Majeure. Both Parties will be excused from the performance of their
obligations under this Agreement to the extent that such performance is
prevented by force majeure and the nonperforming Party promptly provides notice
of the prevention to the other Party. Such excuse will continue only so long as
the condition constituting force majeure continues and the nonperforming Party
takes reasonable efforts to remove the condition. When the force majeure no
longer exists, the affected Party must promptly resume performance. For purposes
of this Agreement, force majeure will include conditions beyond the reasonable
control of the non-performing Party, including an act of God, war, civil
commotion, terrorist act, labor strike or lock-out, epidemic, failure or default
of public utilities or common carriers, destruction of production facilities or
materials by fire, earthquake, storm, flood or like catastrophe, failure of
plant or machinery and act (or failure to act) of a government of any country or
of any Governmental Authority (other than as a result of the non-performing
Party’s failure to comply with Applicable Law). Notwithstanding any provision to
the contrary set forth in this Agreement, a Party will not be excused from
making payments owed hereunder because of a force majeure affecting such Party.
If a force majeure persists for more than [***], then the Parties will discuss
in good faith the potential modification of the Parties’ obligations under this
Agreement in order to mitigate the delays caused by such force majeure.

 

15.9Entire Agreement; Amendments. This Agreement, together with the Schedules
hereto, contains the entire understanding of the Parties with respect to the
collaboration and the licenses granted hereunder. Any other express or implied
agreements and understandings, negotiations, writings and commitments, either
oral or written, in respect to the collaboration and the licenses granted
hereunder are superseded by the terms of this Agreement. The Schedules to this
Agreement are incorporated herein by reference and will be deemed a part of this
Agreement. This Agreement may be amended, or any term hereof modified, only by a
written instrument duly executed by authorized representatives of each Party.
The foregoing will not be interpreted as a waiver of any remedies available to
either Party or its Affiliates as a result of any breach, prior to the Effective
Date, by the other Party or its Affiliates of such Party’s or its Affiliate’s
obligations pursuant to the Nondisclosure Agreement.

 

15.10Headings. The captions to the several Articles, Sections and subsections
hereof are not a part of this Agreement, but are merely for convenience to
assist in locating and reading the several Articles and Sections of this
Agreement.

 

15.11Independent Contractors. It is expressly agreed that BioCryst and Torii
will be independent contractors and that the relationship between the two
Parties will not constitute a partnership, joint venture or agency. Neither
BioCryst nor Torii will have the authority to make any statements,
representations, or commitments of any kind, or to take any action that is
binding on the other Party without the prior written consent of the other Party.

 

15.12Performance by Affiliates. Notwithstanding any provision to the contrary
set forth in this Agreement, either Party will have the right to perform any or
all of its obligations and exercise any or all of its rights under this
Agreement through any Controlled Affiliate (with respect to Torii) or any
Affiliate (with respect to BioCryst). Each Party hereby guarantees the
performance by any Affiliates of such Party’s obligations under this Agreement
and will cause its any such performing Affiliates to comply with the provisions
of this Agreement in connection with such performance.

 

-83-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

15.13Waiver. Any waiver of any provision of this Agreement will be effective
only if in writing and signed by BioCryst and Torii. No express or implied
waiver by a Party of any default under this Agreement will be a waiver of a
future or subsequent default. The failure or delay of any Party in exercising
any rights under this Agreement will not constitute a waiver of any such right,
and any single or partial exercise of any particular right by any Party will not
exhaust the same or constitute a waiver of any other right provided in this
Agreement.

 

15.14Waiver of Rule of Construction. Each Party has had the opportunity to
consult with counsel in connection with the review, drafting and negotiation of
this Agreement. Accordingly, the rule of construction that any ambiguity in this
Agreement will be construed against the drafting Party will not apply.

 

15.15Cumulative Remedies. No remedy referred to in this Agreement is intended to
be exclusive, but each will be cumulative and in addition to any other remedy
referred to in this Agreement or otherwise available under Applicable Law.

 

15.16Business Day Requirements. If any notice or other action or omission is
required to be taken by a Party under this Agreement on a day that is not a
Business Day, then such notice or other action or omission will be deemed to be
required to be taken on the next occurring Business Day.

 

15.17Further Actions. Each Party agrees to execute, acknowledge, and deliver
such further instruments, and to do all such other acts, as necessary or
appropriate in order to carry out the purposes and intent of this Agreement.

 

15.18Construction. Except where the context expressly requires otherwise,
(a) the use of any gender herein will be deemed to encompass references to
either or both genders, and the use of the singular will be deemed to include
the plural (and vice versa), (b) the words “include,” “includes,” and
“including” will be deemed to be followed by the phrase “without limitation,”
(c) the word “will” will be construed to have the same meaning and effect as the
word “shall,” (d) any definition of or reference to any agreement, instrument,
or other document herein will be construed as referring to such agreement,
instrument, or other document as from time to time amended, supplemented, or
otherwise modified (subject to any restrictions on such amendments, supplements
or modifications set forth herein), (e) any reference herein to any person will
be construed to include the person’s successors and assigns, (f) the words
“herein,” “hereof,” and “hereunder” and words of similar import, will each be
construed to refer to this Agreement in its entirety and not to any particular
provision hereof, (g) all references herein to Articles, Sections, Schedules, or
Exhibits will be construed to refer to Articles, Sections, Schedules, or
Exhibits of this Agreement, and references to this Agreement include all
Schedules hereto, (h) the word “notice” means notice in writing (whether or not
specifically stated) and will include notices, consents, approvals and other
written communications contemplated under this Agreement, (i) provisions that
require that a Party, the Parties or any committee hereunder “agree,” “consent,”
“approve,” or the like will require that such agreement, consent, or approval be
specific and in writing, whether by written agreement, letter, approved minutes,
or otherwise (but excluding e-mail and instant messaging), (j) references to any
specific law, rule or regulation, or Section or other division thereof, will be
deemed to include the then-current amendments thereto or any replacement or
successor law, rule or regulation thereof, and (k) the term “or” will be
interpreted in the inclusive sense commonly associated with the term “and/or.”

 

15.19Language; Translations. This Agreement is in the English language only,
which language will be controlling in all respects, and all versions hereof in
any other language will be for accommodation only and will not be binding upon
the Parties. All communications and notices to be made or given by one Party to
the other pursuant to this Agreement, and any dispute proceeding related to or
arising hereunder, will be in the English language. If there is a discrepancy
between any translation of this Agreement and any non-English translation of
this Agreement, this Agreement will prevail.

 

-84-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

15.20Counterparts. This Agreement may be executed in any number of counterparts
by facsimile or PDF signature pages, each of which will be deemed an original,
but all of which together will constitute one and the same instrument.

 

[Remainder of the Page Intentionally Left Blank; Signature Page Follows]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

-85-

Certain information has been omitted from this exhibit in places marked “[***]”
because it is both not material and would likely cause competitive harm to the
registrant if publicly disclosed.

IN WITNESS WHEREOF, the Parties intending to be bound have caused this
Commercialization and License Agreement to be executed by their respective duly
authorized representatives as of the Effective Date.

 

BioCryst Pharmaceuticals, Inc.

 

By: /s/ Jon P. Stonehouse                

 

Name: Jon P. Stonehouse

 

Title: Chief Executive Officer

 

Torii Pharmaceutical Co. Ltd.

 

By: /s/ Goichi Matsuda                  

 

Name: Goichi Matsuda

 

Title: President

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[Signature Page to Commercialization and License Agreement]