Exhibit 10.2

CERTAIN INFORMATION (INDICATED BY ASTERISKS) HAS BEEN OMITTED FROM THIS DOCUMENT
BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE
REGISTRANT IF PUBLICLY DISCLOSED.

Zogenix Inc.

and

Nippon Shinyaku Company Ltd.
Distributorship Agreement

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Table of Contents

Article 1. DefinitionsArticle 2. Grant of Rights2.1Grant of Rights to
Distributor2.2Sub-distribution by Distributor2.3Supply of Product for
Distributorship2.4No Other Rights; Other Limitations2.5Non-Compete Covenant2.6No
Activities Outside the Territory or FieldArticle 3. Governance3.1Joint Steering
Committee3.2Expenses3.3Alliance Managers3.4Scope of GovernanceArticle 4.
Development and Regulatory Activities4.1Nonclinical and Clinical Studies and CMC
Requirements4.2Regulatory Activities4.3Distributor’s Right to Use and
Reference4.4Zogenix’s Right to Use and Reference4.5Adverse Event
Reporting4.6Drug Safety and Pharmacovigilance System including Global Safety
Database4.7Regulatory Audit4.8Use of Subcontractors4.9Recalls4.1Development
ExpensesArticle 5. Commercialization; Supply: Trademarks5.1Commercialization of
the Product.5.2Supply5.3Trademark Rights5.4Commercial ExpensesArticle 6.
Payments6.1Upfront Payment6.2Funding to Support Development of The
Product6.3Regulatory Milestones6.4Sales Milestones6.5Supply PaymentsArticle 7.
Payments, Books and Records7.1Payment Method

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7.2Currency Conversion7.3Taxes7.4Records7.5Audits7.6Late PaymentsArticle 8.
Confidentiality8.1Confidential Information8.2Exceptions8.3Permitted
Disclosures8.4Confidentiality of this Agreement and its Terms8.5Public
Announcements8.6Publication8.7Prior Non-Disclosure Agreements8.8Equitable
ReliefArticle 9. Intellectual Property Ownership and Enforcement9.1Ownership of
Intellectual Property9.2Zogenix Patent Prosecution and
Maintenance9.3Infringement by Third Parties9.4Third Party Intellectual Property
Rights9.5Patent Term Restoration9.6Patent Marking9.7Zogenix Trademarks9.8Product
TrademarksArticle 10. Representations, Warranties and Covenants; Limitation of
Liability10.1Mutual Representations, Warranties and
Covenants10.2Representations, Warranties and Covenants of
Distributor10.3Representations and Warranties of
Zogenix10.4Disclaimer10.5Limitation of LiabilityArticle 11.
Indemnification11.1Indemnification of Zogenix11.2Indemnification of
Distributor11.3Procedure11.4InsuranceArticle 12. Term and
Termination12.1Term12.2Termination12.3Rights on Termination12.4Exercise of Right
to Terminate12.5Damages; Relief12.6Accrued Obligations; Survival

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Article 13. Dispute Resolution13.1Objective13.2Resolution by
Executives13.3ArbitrationArticle 14. General Provisions14.1Governing
Law14.2Force Majeure14.3Assignment14.4Severability14.5Notices14.6Entire
Agreement; Amendments14.7Headings14.8Independent
Contractors14.9Waiver14.1Cumulative Remedies14.11Waiver of Rule of
Construction14.12Interpretation14.13No Third Party Beneficiaries14.14English
Language14.15Counterparts14.16Further Actions

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List of Exhibits
Exhibit 1.70  Unlabeled Drug Product
Exhibit 1.74  Zogenix ZX008 Patents as of the Effective Date
Exhibit 2.3  Material Terms of Supply Agreement
Exhibit 4.2(a)  The initial version of the Regulatory Plan
Exhibit 8.5(a)  Press Release
Exhibit 9.7  Zogenix Trademarks
Exhibit 9.8  Product Trademarks
Exhibit 10.2(b) Form of Compliance Certification

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DISTRIBUTORSHIP AGREEMENT
This DISTRIBUTORSHIP AGREEMENT (“Agreement”) is entered into as of March 18,
2019 (the “Effective Date”) by and between ZOGENIX, INC., having a place of
business at 5959 Horton Street, Suite 500, Emeryville, California 94608(
“Zogenix”) and Nippon Shinyaku Company, Ltd., having a place of business at 14,
Nishinosho-Monguchi-cho, Kisshoin, Minami-ku, Kyoto 601-8550, Japan
(“Distributor”). Zogenix and Distributor may be referred to individually as a
“Party” and collectively as the “Parties”.
RECITALS
WHEREAS, Zogenix is developing its proprietary fenfluramine product, known as
Fintepla®.
WHEREAS, Zogenix wishes to commercialize such product through a distributor that
will promote, market, sell and distribute such product within the Territory;
WHEREAS, Distributor has the ability to promote, market, sell and distribute
such product within the Territory for the treatment of Dravet syndrome and
Lennox-Gastaut syndrome and any additional indications approved in the
Territory, and wishes to be Zogenix’s exclusive distributor of such product for
such indications within the Territory, and Zogenix is willing to grant to
Distributor such exclusive distribution rights on the terms and conditions set
forth in this Agreement; and
WHEREAS, Zogenix agrees to manufacture (or have manufactured) and sell to
Distributor such product for such commercialization activities in the Territory,
on the terms and conditions set forth in this Agreement and in a separate supply
agreement to be entered into by the Parties.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants herein contained, and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, Zogenix and
Distributor hereby agree as follows:
ARTICLE 1.
DEFINITIONS
1.1 “Affiliate” of a Party means any entity that, directly or indirectly,
through one or more intermediaries, controls, is controlled by, or is under
common control with such Party, as the case may be, but for only so long as such
control exists. As used in this Section 1.1, “control” means (a) to possess,
directly or indirectly, the power to direct the management or policies of an
entity, whether through ownership of voting securities, or by contract relating
to voting rights or corporate governance; or (b) direct or indirect beneficial
ownership of more than fifty percent (50%) (or such lesser percentage which is
the maximum allowed to be owned by a foreign corporation in a particular
jurisdiction) of the voting share capital or other equity interest in such
entity.

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1.2 “Alliance Manager” has the meaning set forth in Section 3.3.
1.3 “Annual Report” has the meaning set forth in Section 6.5(c).
1.4 “Applicable Laws” means the applicable provisions of any and all national,
supranational, regional, state and local laws, treaties, statutes, rules,
regulations, administrative codes, industry codes, guidance, ordinances,
judgments, decrees, directives, injunctions, orders or permits (including
Regulatory Approvals) of or from any court, arbitrator, Regulatory Authority or
governmental agency or authority having jurisdiction over or related to the
subject item, including the FCPA, export control, embargo, trade sanction and
data privacy laws, regulations, rules and licenses, and other laws and
regulations pertaining to domestic or international corruption, commercial
bribery, fraud, embezzlement or money laundering.
1.5 “Business Day” means a day other than a Saturday, Sunday, any public
holiday, or any bank holiday in the United States or Japan.
1.6 “Change of Control” means any (a) direct or indirect acquisition of assets
of a Party (i) equal to fifty percent (50%) or more of the fair market value of
a Party’s consolidated assets, or (ii) to which fifty percent (50%) or more of a
Party’s net revenues or net income on a consolidated basis are attributable, or
(iii) representing substantially all of the properties or assets related to a
Party’s obligations under this Agreement, (b) direct or indirect acquisition by
a Person, or group of Persons acting in concert, of fifty percent (50%) or more
of the voting equity interests of a Party, (c) tender offer or exchange offer
that if consummated would result in any Person, or group of Persons acting in
concert, beneficially owning fifty percent (50%) or more of the voting equity
interests of a Party, (d) merger, consolidation, other business combination or
similar transaction involving a Party, pursuant to which any Person would own
fifty percent (50%) or more of the consolidated assets, net revenues or net
income of a Party, taken as a whole, or which results in the holders of the
voting equity interests of a Party immediately prior to such merger,
consolidation, business combination or similar transaction ceasing to hold fifty
percent (50%) or more of the combined voting power of the surviving, purchasing
or continuing entity immediately after such merger, consolidation, business
combination or similar transaction, (e) liquidation or dissolution (or the
adoption of a plan of liquidation or dissolution) of a Party, or (f) declaration
or payment of an extraordinary dividend (whether in cash or other property) by a
Party, where the amount of the dividend or the in specie property which is the
subject of the dividend would otherwise come within the application of any of
clauses (a)-(e) above, in all cases where such transaction is to be entered into
with any Person other than the other Party.
1.7 “CMC” means chemistry, manufacturing and controls.
1.8 “Commercialization” means all activities directed to marketing, promoting,
advertising, exhibiting, distributing (including storage for distribution or
inventory), detailing, selling, (and offering for sale or contracting to sell),
or otherwise commercially exploiting the Product in the Field in the Territory.
1.9 “Commercialization Plan” has the meaning set forth in Section 5.1(b).

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1.10 “Commercially Reasonable Efforts” means, with respect to a Party’s specific
obligations under this Agreement, that level of efforts and resources, [***].
Commercially Reasonable Efforts requires that the applicable Party: (i) [***],
(ii) [***], and (iii) [***].
1.11 “Confidential Information” has the meaning set forth in Section 8.1.
1.12 “Confidentiality Agreement” means that certain Mutual Confidential
Disclosure Agreement, dated June 21, 2018, between Zogenix and Distributor.
1.13 “Control” (including any variations such as “Controlled” and “Controlling”)
means, with respect to any Information, Data, Patent or other intellectual
property rights, possession by a Party of the ability (whether by ownership or
grant of rights, other than pursuant to this Agreement) to grant to the other
Party the applicable access or other right under this Agreement without
violating the terms of an agreement with a Third Party.
1.14 “Data” means any and all scientific, technical or test data pertaining to
the Product in the Field that is generated by or under the authority of
Distributor or its Affiliates, Sub-distributors or other subcontractors or by or
under the authority of Zogenix or Zogenix ex-Territory Distributors before or
during the Term, including research data, clinical pharmacology data, CMC data
(including analytical and quality control data and stability data), preclinical
data, clinical data and all submissions made in association with an IND or MAA
filed in or outside the Territory with respect to the Product in the Field, in
each case to the extent such data either (a) is Controlled by Zogenix on the
Effective Date or (b) comes within a Party’s Control during the Term.
1.15 “Development” means all activities directed to research, non-clinical and
preclinical studies and trials, CMC Data collection, clinical studies and
trials, Investigator Initiated Studies, toxicology studies, publication and
presentation of study results, preparation and submission to Regulatory
Authorities of an MAA concerning the Product, interacting with Regulatory
Authorities prior to and following Regulatory Approval of the Product, and
Product pricing negotiations and decisions concerning the Product.
1.16 “Disclosing Party” has the meaning set forth in Section 8.1.
1.17 “Distribution Term” means the period commencing on the first Regulatory
Approval of the Product in the Territory and continuing until [***], or if this
Agreement is terminated earlier pursuant to Article 12, the effective date of
such termination.
1.18 “Distributor Invention” has the meaning set forth in Section 9.1(b)(i).
1.19 “Executives” has the meaning set forth in Section 3.1(d).
1.20 “FCPA” means the U.S. Foreign Corrupt Practices Act (15 U.S.C. § 78dd-1 et
seq.), as amended.
1.21 “FDA” means the Food and Drug Administration, or any successor agency
thereto
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having the administrative authority to regulate the marketing of human
pharmaceutical products in the United States.
1.22 “Field” means the Indications of treatment for the Product in the
Territory.
1.23 “First Commercial Sale” means the first bona fide, arm’s-length sale of the
Product in the Field in the Territory following Regulatory Approval of the
Product in the Field in the Territory.
1.24 “Fiscal Quarter” means a period of three (3) consecutive months during a
Fiscal Year beginning on and including April 1st, July 1st or October 1st or
January 1st.
1.25 “Fiscal Year” means a year that starts from April 1st and ends on
March 31st.
1.26 “Fully-Burdened Manufacturing Cost” means the costs incurred by Zogenix
that are directly attributable to and reasonably allocated to the manufacture
and delivery of the Product to Distributor. Fully-Burdened Manufacturing Costs
shall include the following: [***].
1.27 “Generic Product” means a pharmaceutical product that (a) [***]; (b) [***];
(c) [***]; and (d) [***].
1.28 “IFRS” means international financial reporting standards, as may be amended
from time to time.
1.29 “IND” means any Investigational New Drug application, as defined in Title
21 of the Code of Federal Regulations, on file with the FDA before the
commencement of clinical trials of the Product in humans, or any comparable
filing with any Regulatory Authority.
1.30 “Indemnitee” has the meaning set forth in Section 11.3.
1.31 “Indemnitor” has the meaning set forth in Section 11.3.
1.32 “Indication” means the treatment of Dravet syndrome, Lennox-Gastaut
syndrome, [***] during the Distribution Term.
1.33 “Indirect Losses” means any damages or other losses involving, but only to
the extent of, any loss of profits, diminution in value, or incidental,
indirect, consequential, special or punitive damages.
1.34 “Information” means information, ideas, inventions, discoveries, concepts,
formulas, practices, procedures, processes, methods, knowledge, know-how, trade
secrets, technology, inventories, machines, techniques, development, designs,
drawings, computer programs, skill, experience, documents, apparatus, results,
clinical and regulatory strategies, documentation, information and submissions
pertaining to, or made in association with, filings with any Regulatory
Authority, data, including pharmacological, toxicological and clinical data,
analytical and quality control data, manufacturing data and descriptions, patent
and legal data,
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market data, financial data or descriptions, specifications and the like, in
written, electronic or other form, now known or hereafter developed, whether or
not patentable.
1.35 “Invention” means any new and useful process, article of manufacture,
composition of matter, formulation or apparatus, or any improvement thereof,
discovery or finding, whether or not patentable, as determined in accordance
with the patent laws of the United States of America.
1.36 “Japan GAAP” means Japan generally accepted accounting principles, as may
be amended from time to time.
1.37 “Joint Steering Committee” or “JSC” has the meaning set forth in
Section 3.1.
1.38 “Losses” has the meaning set forth in Section 11.1.
1.39 “MAA” means a marketing authorization application or equivalent
application, and all amendments and supplements thereto, filed with a Regulatory
Authority.
1.40 “MAH” means a marketing authorization holder of the Product in the Field in
the Territory.
1.41 “MHLW” means the Japanese Ministry of Health, Labor and Welfare.
1.42 “Net Price” means, for any Fiscal Year, the unit price of the Product in
the Territory in the Field calculated by dividing the aggregate Net Sales for
the Product in the Territory in such Fiscal Year by the total number of units of
the Product sold by or on behalf of Distributor or its Affiliate or
Sub-distributor in the Territory in such Fiscal Year.
1.43 “Net Sales” means, with respect to any period of time, the gross amounts
invoiced for sales or other dispositions of the Product in the Territory by or
on behalf of Distributor or its Affiliates or Sub-distributors to Third Parties
(other than Sub-distributors) during such period, less the value added taxes
levied on or measured by the billing amount for the Product to the extent
included in the gross invoiced sales price for the Product or otherwise directly
paid or incurred by Distributor or its Affiliates or Sub-distributors, as
applicable, with respect to the sale or other disposition of the Product, less
the following deductions to the extent actually allowed, paid, incurred or
accrued during the applicable period, calculated in accordance with Japan GAAP
or IFRS (consistently applied):
[***]
Net Sales shall be calculated in accordance with Japan GAAP or IFRS,
consistently applied in the Territory and shall be consistent with net sales
reported in Distributor’s audited financial statements. If net sales reported in
Distributor’s audited financial statements include discounts for products sold
in combination or bundled with other products, these discounts will not be
included in the calculation of Net Sales of the Product.

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Sales of a Product for use in conducting clinical trials of the Product in the
Territory in order to obtain Regulatory Approval of the Product in the Territory
shall be excluded from Net Sales calculations for all purposes.
Upon any sale or other disposition of the Product for any consideration other
than exclusively monetary consideration on bona fide arm’s-length terms, for
purposes of calculating Net Sales under this Agreement, the Product shall be
deemed to be sold exclusively for money at the average sales price during the
applicable reporting period generally achieved for the Product in the Field in
the Territory when the Product is sold alone and not with other products.
Distributor and its Affiliates and Sub-distributors shall not sell the Product
in combination with or as part of a bundle with other products, or offer
packaged arrangements to customers that include the Product, in such a manner as
to disproportionately discount the selling price of the Product as compared with
the weighted-average discount applied to the other products, as a percent of the
respective list prices (or if not available, a good faith estimate thereof) of
such products and the Product prior to applying the discount.
1.44 “NHI” means the Japanese national health insurance system, or its successor
system.
1.45 “NHI Price” means the reimbursement price of the maximum daily dose of
Product for purposes of the NHI.
1.46 “NHI Price Listing” means the listing of the NHI Price by Central Social
Insurance Medical Council (Chuikyo) of the MHLW.
1.47 “Out-of-Pocket Costs and Expenses” means the costs and expenses incurred by
one or both Parties (as applicable) that are directly attributable to and
reasonably allocated to a specified project, program or task. Out-of-Pocket
Costs and Expenses shall include payments made to third parties such as contract
research organizations and investigators and the fully burdened cost of drug
product. Out-of-Pocket Costs and Expenses shall not include a Party’s employee
costs.
1.48 “Patent” means (a) any patent, certificate of invention, application for
certificate of invention, priority patent filing and patent application, and
(b) any renewal, division, continuation (in whole or in part) or request for
continued examination of any of such patent, certificate of invention and patent
application, and any patent or certificate of invention issuing thereon, and any
reissue, reexamination, extension, restoration by any existing or future
extension or restoration mechanism, division, renewal, substitution,
confirmation, registration, revalidation, revision and addition of or to any of
the foregoing.
1.49 “Person” means any individual, corporation, partnership, limited liability
company, trust or other entity.
1.50 “Pharmacovigilance Agreement” has the meaning set forth in Section 4.5.

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1.51 “PMDA” means the Japanese Pharmaceuticals and Medical Devices Agency, and
local counterparts thereto, and any successor agency(ies) or authority thereto
having substantially the same function.
1.52 “Product” means Zogenix’s proprietary fenfluramine product, known as
Fintepla®, or any drug product containing a salt, enantiomer, or polymorph of
fenfluramine.
1.53 “Product Invention” has the meaning set forth in Section 9.1(b)(i).
1.54 “Product Trademark” has the meaning set forth in Section 9.8(a).
1.55 “Public Official or Entity” means (a) any officer, employee (including
physicians, hospital administrators or other healthcare professionals), agent,
representative, department, agency, de facto official, representative, corporate
entity, instrumentality or subdivision of any government, military or
international organization, including any ministry or department of health or
any state-owned or affiliated company or hospital, or (b) any candidate for
political office, any political party or any official of a political party.
1.56 “Transfer Price” has the meaning set forth in Section 6.5(a).
1.57 “Receiving Party” has the meaning set forth in Section 8.1.
1.58 “Regulatory Approval” means any and all approvals (except NHI Price
Listing), licenses, registrations, or authorizations of Regulatory Authorities
in the applicable regulatory jurisdiction that are necessary for the
manufacture, use, storage, import, transport and/or sale of a pharmaceutical
product in such regulatory jurisdiction.
1.59 “Regulatory Authority” means any national, regional, state or local
regulatory agency, department, bureau, commission, council or other governmental
entity whose review and/or approval is necessary for the manufacture, packaging,
use, storage, import, export, distribution or promotion of a pharmaceutical
product in the applicable regulatory jurisdiction, including the PMDA in the
Territory. If governmental approval is required for pricing or reimbursement by
national health insurance (or its local equivalent), “Regulatory Authority”
shall also include any national, regional, state or local regulatory agency,
department, bureau, commission, council or other governmental entity whose
review and/or approval of pricing or reimbursement is required.
1.60 “Regulatory Filings” means all applications, approvals, licenses,
notifications, registrations, submissions and authorizations made to or received
from a Regulatory Authority in connection with the development, manufacture or
commercialization of a pharmaceutical product, including any INDs, MAAs and
Regulatory Approvals.
1.61 “Regulatory Plan” has the meaning set forth in Section 4.2(a).
1.62 “SEC” means the U.S. Securities and Exchange Commission or any successor
agency.

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1.63 “Sub-distributor” means any Person other than Distributor or its Affiliates
that Distributor appoints to market, promote, offer for sale, sell, import or
distribute the Product in the Field in the Territory, beyond the mere right to
purchase the Product from Distributor or its Affiliates for end use.
1.64 “Supply Agreement” has the meaning set forth in Section 5.2.
1.65 “Territory” means Japan.
1.66 “Third Party” means any governmental authority or Person other than
Zogenix, Distributor and their respective Affiliates.
1.67 “Third Party Claims” has the meaning set forth in Section 11.1.
1.68 “Trademark” means any word, name, symbol, color, designation or device or
any combination thereof, including any trademark, trade dress, brand mark,
service mark, trade name, brand name, logo or business symbol, whether or not
registered, as determined in accordance with the trademark laws of the Unites
States of America.
1.69 “United States” or “U.S.” means the United States of America, including its
territories and possessions and the District of Columbia.
1.70 “Unlabeled Drug Product” means [***].
1.71 “Zogenix ex-Territory Distributor” means a licensee, collaborator or
distributor engaged by Zogenix or any of its Affiliates to market, promote or
sell the Product outside the Territory.
1.72 “Zogenix Indemnitees” has the meaning set forth in Section 11.1.
1.73 “Zogenix Know-How” means all Information and Data that Zogenix Controls as
of the Effective Date or during the Term, which Information is necessary or
reasonably useful to file for, obtain or maintain Regulatory Approval or to
market, promote, sell, offer for sale or import the Product in the Field in the
Territory.
1.74 “Zogenix Patents” means all Patents that Zogenix Controls as of the
Effective Date or during the Term, which Patents would be infringed, absent a
license, by the use, sale, offer for sale or import of the Product in the Field
in the Territory, including any Patents issuing from the applications listed in
Exhibit 1.74.
1.75 “Zogenix Technology” means the Zogenix Know-How and Zogenix Patents.
1.76 “Zogenix Trademark” has the meaning set forth in Section 9.7.

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ARTICLE 2.
GRANT OF RIGHTS
2.1 Grant of Rights to Distributor. Subject to the terms and conditions of this
Agreement, Zogenix hereby appoints Distributor, and Distributor accepts
appointment, as the exclusive distributor (even as to Zogenix) of the Product in
the Field in the Territory during the Term, and grants to Distributor the
exclusive rights to maintain Regulatory Approval of (while Distributor is the
MAH Party), package, promote, market, offer for sale, sell, import and
distribute the Product in the Field in the Territory during the Term. The
Parties agree that the rights granted in this Section 2.1 do not grant any right
or license to, and Distributor shall not, supply, sell, offer for sale or
otherwise dispose of or provide access to the Product in the Territory unless
and until the Product obtains Regulatory Approval in the Field in the Territory.
2.2 Sub-distribution by Distributor. Distributor shall not have the right to
(a) appoint any Sub-distributors for the Product in the Field in the Territory
or (b) otherwise subcontract any sales, marketing, distribution or promotional
activities with respect to the Product in the Field in the Territory, including
to any contract sales organization, in each case, except with the prior written
approval of Zogenix. If Zogenix grants such approval, in accordance with this
Section 2.2 and Section 4.8, any Sub-distributor agreement shall be in writing
and, with the exception of the financial terms, on substantially the same terms
as this Agreement, to the extent applicable to the Sub-distributor’s activity,
and shall provide for the assignment of all Data generated by such
Sub-distributors to Distributor, and the right for Distributor to terminate such
agreement immediately in the event of any violation by such Sub-distributor of
the FCPA or other Applicable Laws. Distributor shall be responsible for the acts
or omissions of its Sub-distributors under any Sub-distributors agreement,
including any such act or omission that would constitute a breach hereunder. In
the event of any such breach by a Sub-distributor of its obligations to comply
with the FCPA or other Applicable Laws, Distributor shall immediately terminate
the applicable Sub-distributor agreement(s), unless otherwise agreed to by
Zogenix in writing. Within [***] after execution thereof, Distributor shall
provide Zogenix with a full and complete copy of each Sub-distributor agreement
(provided that Distributor may redact any confidential information contained
therein that is not relevant to compliance with this Agreement).
2.3 Supply of Product for Distributorship. Zogenix shall supply (or have
supplied) to Distributor, in accordance with the terms set forth on Exhibit 2.3,
and Distributor shall purchase exclusively from Zogenix, Distributor’s and its
Affiliates’ and Sub-distributors’ Unlabeled Drug Product requirements of the
Product for sale by Distributor or its Affiliates or Sub-distributors in the
Territory in the Field, subject to and under the provisions of Section 5.2 and
the Supply Agreement. Distributor shall purchase all such amounts of Unlabeled
Drug Product of the Product for sale by Distributor supplied by Zogenix under
the payment provisions of Section 6.5 and Article 7. Notwithstanding the
foregoing, upon the reasonable request of Distributor, Zogenix will provide
Product free of charge to Distributor to the extent necessary for Distributor to
meet its analytical testing obligations hereunder.

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2.4 No Other Rights; Other Limitations. Except for the rights expressly granted
in this Agreement, Zogenix retains all rights under the Zogenix Technology and
with respect to the Product, including the exclusive right to manufacture and
sell the Product to Distributor, to develop the Product, and to promote, market
and sell the Product outside the Territory, and all rights with respect to the
Product outside the Field in the Territory. No rights shall be deemed granted by
one Party to the other Party under this Agreement by implication, estoppel or
otherwise. Distributor agrees not to use any Zogenix Technology except as
necessary to file for and maintain Regulatory Approval of, promote, market,
sell, offer for sale, distribute and import the Product in the Field in the
Territory during the Term in accordance with the terms of this Agreement and the
Supply Agreement. Without limiting the foregoing, Distributor agrees that in no
event shall Distributor or its Affiliates manufacture or have manufactured the
Product, or purchase the Product from any party other than Zogenix pursuant to
the Supply Agreement. Without limiting the foregoing, Distributor further
acknowledges that it has no right to and agrees that it will not perform any
studies of the Product or allow its Affiliate or any Third Party to perform any
studies of the Product (including any investigator-initiated studies) except
with the prior written approval of Zogenix, which Zogenix may withhold in its
sole discretion.
2.5 Non-Compete Covenant. During the Term, without the prior written approval of
Zogenix, Distributor shall not, and shall cause its Affiliates not to, either
directly or indirectly, file for Regulatory Approval of, promote, market, offer
for sale, sell, import or distribute in the Territory any product containing
fenfluramine or any salt, enantiomer, or polymorph of fenfluramine, or any
product for [***].
2.6 No Activities Outside the Territory or Field. Distributor shall not, and
shall cause its Affiliates and Sub-distributors not to, (a) actively seek
customers for the Product outside the Territory or the Field, (b) establish or
maintain a branch office, warehouse, or distribution facility for the Product
outside the Territory, (c) engage in any advertising or promotional activities
relating to the Product directed to customers outside the Territory or directed
to any use outside the Field, or (d) solicit orders from any prospective
purchaser with its principal place of business located outside the Territory. If
Distributor receives any order from a prospective purchaser outside the
Territory, Distributor shall not accept any such order but shall immediately
refer that order to Zogenix.

ARTICLE 3.
GOVERNANCE
3.1 Joint Steering Committee. The Parties shall establish a joint steering
committee (the “Joint Steering Committee” or “JSC”) to oversee the activities of
the Parties pursuant to this Agreement.
(a) Composition. The JSC will be comprised of [***] members appointed by
Distributor and [***] members appointed by Zogenix, which members shall be
senior level employees or representatives of each Party with decision-making
authority. Each Party will
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notify the other Party of its initial JSC members within [***] after the
Effective Date. The Parties, through the JSC, may change the number of JSC
members as long as an equal number of members from each of Distributor and
Zogenix is maintained. Each Party may change its JSC members at any time by
written notice to the other Party, which may be delivered at a scheduled meeting
of the JSC. Any member of the JSC may designate a substitute to attend and
perform the functions of that member at any meeting of the JSC. Zogenix shall
appoint one (1) of its members as chair, whose role shall be to convene and
preside at meetings of the JSC, but the chair shall not be entitled to prevent
items from being discussed or to cast any tie-breaking vote. Each Party may,
with the consent of the other Party, such consent not to be unreasonably
withheld or delayed, invite non-member, non-voting representatives of such Party
to attend meetings of the JSC.
(b) Responsibilities. The JSC shall be responsible for oversight of the Parties’
activities under this Agreement with respect to filing for, obtaining and
maintaining Regulatory Approval and commercializing (including commercial supply
to Distributor and marketing and sales) the Product in the Field in the
Territory. Without limiting the foregoing, the JSC shall:
(i) review, discuss and approve the Regulatory Plan, including all amendments
thereto;
(ii) review, discuss and approve the Commercialization Plan, including all
amendments thereto;
(iii) periodically review, discuss and assess the progress and results of the
Parties under the Regulatory Plan and Commercialization Plan to ensure, to the
extent reasonably practical, compliance with obligations under this Agreement;
(iv) periodically discuss the status of the development and commercialization of
the Product in the Field outside the Territory;
(v) review Distributor’s binding and non-binding forecasts for the Product and
monitor the production capacity of Zogenix and its Third Party manufacturers;
(vi) periodically review Distributor’s and Zogenix’s pharmacovigilance policies
and procedures;
(vii) facilitate the exchange of Data between the Parties; and
(viii) perform such other duties as are specifically assigned by the Parties to
the JSC in this Agreement.
(c) Meetings. The JSC will hold meetings at such frequency as determined by the
JSC members, but no less than twice every calendar year. Such meetings may be in
person, via videoconference, or via teleconference; provided, that no fewer than
two (2) JSC
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meetings each calendar year prior to First Commercial Sale shall be in-person
unless the Parties otherwise agree. The location of in-person JSC meetings will
alternate between Zogenix’s offices and Distributor’s offices, unless the
Parties otherwise agree. At least [***] prior to each JSC meeting, each Party
shall provide written notice to the other Party of agenda items proposed by such
Party for discussion or decision at such meeting, together with appropriate
information related thereto. Reasonably detailed written minutes will be kept of
all JSC meetings and will reflect material decisions made at such meetings.
Meeting minutes will be prepared by each Party on an alternating basis and sent
to each member of the JSC for review and approval within [***] after a meeting.
Minutes will be deemed approved unless a member of the JSC objects to the
accuracy of such minutes within [***] of receipt.
(d) Decisions.  The JSC may make decisions with respect to any subject matter
that is within the JSC’s responsibilities. Subject to this Section 3.1(d), all
decisions of the JSC shall be made by unanimous vote, with Zogenix and
Distributor each having, collectively, among its respective members, one (1)
vote in all such decisions. If the JSC cannot reach consensus with regard to any
matter to be decided by the JSC within [***] after such matter has been brought
to the JSC’s attention, then such matter shall be referred to the Chief
Executive Officer of Zogenix and the Director, Member of the Board of
Distributor (the “Executives”) for resolution. If the Executives cannot resolve
the issue within [***] after the matter has been brought to their attention
then:
(i) Subject to good faith consideration of the views of Distributor, Zogenix
shall have the tie-breaking vote on all matters to be decided by the JSC
relating to [***]; provided, however, [***]; and
(ii) Subject to good faith consideration of the views of Zogenix and to Section
3.1(d)(iii), Distributor shall have the tie-breaking vote on all matters to be
decided by the JSC relating to [***]; provided, however, [***]; and
(iii) Subject to good faith consideration of the views of Zogenix and Section
12.2(g), Distributor shall have the tie-breaking vote on the decision of [***],
unless otherwise mutually agreed between the Parties; and
(iv) Subject to good faith consideration of the views of Distributor, Zogenix
shall have the tie-breaking vote on all matters other than the decisions set
forth in Section 3.1(d)(ii) and (iii) to be decided by the JSC that may affect
commercialization outside the Territory; provided, however, that Zogenix shall
not have power to amend or waive compliance with this Agreement or the
Commercialization Plan.
(e) Discontinuation of JSC Participation. The activities to be performed by the
JSC relate solely to governance under this Agreement, and are not intended to be
or involve the delivery of services. The JSC will continue to exist until the
Parties mutually agreeing to disband the JSC. Once the Parties mutually agree to
disband the JSC, the JSC shall have no further obligations under this Agreement
and, thereafter, each Party shall designate a contact person for the exchange of
information under this Agreement, and decisions of the JSC shall be
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decisions as between the Parties, subject to the decision-making authority under
Section 3.1(d) and other terms and conditions of this Agreement.
3.2 Expenses. Each Party shall bear all its own costs, including expenses
incurred by the members nominated by it, in connection with its members’ JSC
representation and meetings.
3.3 Alliance Managers. Promptly after the Effective Date, each Party shall
appoint an individual to act as the alliance manager for such Party (the
“Alliance Manager”). Each Alliance Manager will be permitted to attend meetings
of the JSC as non-voting participants. The Alliance Managers will be the primary
contact for the Parties regarding the activities contemplated by this Agreement
and shall facilitate all such activities hereunder. Each Party may replace its
Alliance Manager with an alternative representative at any time with prior
written notice to the other Party. Any Alliance Manager may designate a
substitute to temporarily perform the functions of that Alliance Manager.
3.4 Scope of Governance. Notwithstanding the creation of the JSC, each Party
shall retain the rights, powers and discretion granted to it hereunder, and the
JSC shall not be delegated or vested with rights, powers or discretion unless
such delegation or vesting is expressly provided herein or the Parties expressly
so agree in writing. The JSC shall not have the power to amend or modify this
Agreement, and no decision of the JSC shall be in contravention of any terms and
conditions of this Agreement. It is understood and agreed that issues to be
formally decided by the JSC are only those specific issues that are expressly
provided in this Agreement to be decided by the JSC. In no event shall the JSC
have any decision-making authority with respect to matters relating to the
Product outside the Territory or outside the Field. For clarity, any decision of
an Executive made in resolution of a dispute of the JSC pursuant to Section
3.1(d) shall be treated as decisions of the JSC for purposes of this Agreement.
It is understood between the Parties that under no circumstances are the
activities to be performed by the JSC intended or allowed to violate any
Applicable Laws (including but not limited to any competition and/or antitrust
law).

ARTICLE 4.
DEVELOPMENT AND REGULATORY ACTIVITIES
4.1 Nonclinical and Clinical Studies and CMC Requirements. Promptly after the
Effective Date, the JSC will discuss what nonclinical or clinical Development
studies or CMC requirements are required to obtain Regulatory Approval of the
Product for the treatment of Dravet syndrome and Lennox-Gastaut syndrome or
would otherwise be useful for the Commercialization of the Product in the Field
in the Territory, and if Zogenix agrees that such Development activities should
be conducted, Zogenix will be responsible for conducting or having conducted all
such Development activities. All non-clinical and clinical studies and CMC
requirements completed or initiated by Zogenix as of the Effective Date or any
such non-clinical and clinical studies and CMC requirements that are described
in the initial version of Regulatory Plan, shall be conducted at Zogenix’s own
cost and expense, except for Distributor’s payment
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obligations under Section 6.2 and as otherwise expressly set forth herein. Any
additional Territory-specific Development activities not set forth in the
initial version of the Regulatory Plan, including those conducted at the
suggestion or requirement of the MHLW or at [***] incurred by the Parties while
conducting such Territory-specific Development activities. For clarity,
Distributor shall have no right to conduct any Development activities for the
Product unless otherwise agreed by Zogenix, and Zogenix shall have and retain
all rights, in its sole discretion, to conduct any Development activities for
the Product in the Territory outside the Field or any Development activities
outside the Territory.
4.2 Regulatory Activities.
(a) Regulatory Plan. All regulatory Development activities with respect to the
Product in the Field in the Territory will be conducted in accordance with a
comprehensive regulatory plan (as amended in accordance with this Agreement, the
“Regulatory Plan”) which sets forth [***]. The initial version of the Regulatory
Plan prepared by Zogenix and agreed to by Distributor will be attached to this
Agreement as Exhibit 4.2(a) [***]. Any changes and updates to the Regulatory
Plan must be approved by the JSC, subject to the decision-making procedures set
forth in Section 3.1(d). As between the Parties, Zogenix will have the sole
right and obligation to conduct (itself or through an Affiliate or Third Party)
nonclinical and clinical studies concerning the Product in the Field in or for
the Territory. Zogenix shall provide updates to the JSC concerning its progress
under the Regulatory Plan and copies of final nonclinical and clinical study
reports following completion of such Development studies. The JSC shall discuss
such activities, including any updates on the progress and results thereof
provided by Zogenix. During the Term, Zogenix shall use Commercially Reasonable
Efforts to Develop the Product in the Field in the Territory in accordance with
the Regulatory Plan and the terms of this Agreement.
(b) Global Clinical Studies for New Indications. In the event that Zogenix
intends to conduct a global (including the Territory) clinical trial of the
Product for indications other than Dravet syndrome and Lennox-Gastaut syndrome
(a “Global Study”), Zogenix will provide a summary of such Global Study to
Distributor for review. In the event Distributor agrees to participate in a
Global Study, Zogenix (or its designee) will be responsible for conducting such
Global Study, including in the Territory, [***].
(c) Conduct of Regulatory Activities. Subject to Section 4.2(d), Zogenix shall
be the marketing authorization holder for the Product in the Territory, and
Zogenix shall be deemed the MAH Party and Distributor deemed the Non-MAH Party
for purposes of this Agreement. Zogenix shall use Commercially Reasonable
Efforts to [***]. In addition, Zogenix shall use Commercially Reasonable Effort
to ensure [***] shall have the capabilities and obtain the necessary licenses
for filing an MAA for the Product in the Territory in advance of the planned MAA
submission date in the initial version of Regulatory Plan.
(i) Regulatory Approval Activities. Zogenix will be responsible for filing for
and obtaining Regulatory Approval of the Product in the Field in the Territory.
In connection with such activities, Zogenix shall be responsible for preparing
and filing INDs and
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other necessary Regulatory Filings and for communicating with Regulatory
Authorities in the Territory, except as otherwise mutually agreed to by the
Parties in writing. Zogenix shall be responsible for preparing, filing and
obtaining Regulatory Approval of the Product in the Field in the Territory, all
in accordance with the Regulatory Plan. Zogenix shall ensure that the
Distributor is involved in the planning and conduct of all such activities and
the decisions with respect thereto, including discussions with any Regulatory
Authority and any decisions regarding the labeling of the Product in the Field
in the Territory. Zogenix shall consider in good faith all input provided by the
Distributor with respect to such regulatory approval activities. In connection
with such activities, Zogenix shall: (i) timely inform the Distributor of any
scheduled meetings with Regulatory Authorities in the Territory with respect to
the Product in the Field as soon as practicable in order to allow the
Distributor time to convey its opinion on the matter and (ii) use all reasonable
efforts to ensure that the Distributor is afforded the opportunity to
participate in such meetings. Zogenix shall keep the Distributor regularly and
fully informed of the preparation, Regulatory Authority review and approval of
submissions and communications with Regulatory Authorities with respect to the
Product in the Field in the Territory. In particular, Zogenix shall promptly
provide the Distributor with copies of all material documents, information and
correspondence received from or provided to a Regulatory Authority with respect
to the Product in the Field in the Territory and, upon reasonable request, with
copies of any other documents, reports and communications from or to any
Regulatory Authority relating to the Product in the Field in the Territory, as
well as written summaries of all material oral communications with a Regulatory
Authority with respect to the Product in the Field in the Territory.
(ii) Post-Approval Regulatory Activities. Following the filing of the MAA for
the Product in the Territory, Zogenix and Distributor shall collaborate in good
faith concerning a pricing negotiation strategy for the Product. Following
Regulatory Approval of the Product in the Field in the Territory, Zogenix will
be responsible for negotiating and obtaining initial pricing approval for the
Product with the applicable Regulatory Authority in accordance with such
strategy. The MAH Party shall use Commercially Reasonable Efforts to maintain
Regulatory Approval for the Product in the Field in the Territory. The MAH Party
shall be responsible for all interactions with Regulatory Authorities with
respect to the Product in the Field in the Territory during the Term and
maintaining Regulatory Approval of the Product in the Field in the Territory. In
connection with such activities, the MAH Party shall: (i) timely inform the
Non-MAH Party of any scheduled meetings with Regulatory Authorities in the
Territory with respect to the Product in the Field as soon as practicable in
order to allow the Non-MAH Party time to convey its opinion on the matter and
(ii) use all reasonable efforts to ensure that the Non-MAH Party is afforded the
opportunity to participate in such meetings. The MAH Party shall keep the
Non-MAH Party regularly and fully informed of the preparation of submissions and
communications with Regulatory Authorities with respect to the Product in the
Field in the Territory. In particular, the MAH Party shall promptly provide the
Non-MAH Party with copies of all material documents, information and
correspondence received from or provided to a Regulatory Authority with respect
to the Product in the Field in the Territory and, upon reasonable request, with
copies of any other documents, reports and communications from or to any
Regulatory Authority relating to the Product in the Field in the Territory, as
well as written
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summaries of all material oral communications with a Regulatory Authority with
respect to the Product in the Field in the Territory.
(A) Post-Marketing Surveillance Studies. The MAH Party shall be responsible for
conducting any post-marketing surveillance studies, including those required by
the MHLW or Applicable Law, that are required to maintain the MAA. The MAH Party
shall ensure that Non-MAH Party is involved in the planning and conduct of all
such post-approval activities and the decisions with respect thereto, including
discussions with any Regulatory Authority and any decisions regarding any
post-marketing surveillance studies with respect to, the Product in Field in the
Territory. The MAH Party shall consider in good faith all input provided by
Zogenix with respect to such regulatory activities. The MAH Party shall be
responsible for filing any post-marketing surveillance studies with the MHLW.
(B) Post-Approval Clinical Studies. Zogenix shall be responsible for conducting
any post-approval clinical study that is requested upon or after approval or
otherwise required by the MHLW as a condition of or to maintain the MAA
approval. [***] shall bear [***] the total Out-of-Pocket Costs and Expenses
incurred by the Parties while conducting any such post-approval clinical study
that is for the Territory. Zogenix shall ensure that Distributor is involved in
the planning and conduct of all such post-approval clinical studies and the
decisions with respect thereto, including discussions with any Regulatory
Authority and any decisions regarding any post-approval clinical study with
respect to, the Product in Field in the Territory. Zogenix shall consider in
good faith all input provided by the Distributor with respect to such
post-approval clinical study. The MAH Party shall be responsible for filing any
post-approval clinical studies with the MHLW.
(C) Risk Management Plan. Zogenix shall be responsible for filing the initial
risk management plan, if any, and approving any subsequent changes thereto. The
MAH Party shall be responsible for conducting or having conducted any risk
management plan requested or required by the MHLW. The Distributor shall support
and implement the risk management plan and cooperate with Zogenix, and the
Parties shall share and discuss the results and data generated from any risk
management plan required by MHLW. The Distributor shall collaborate with Zogenix
to ensure global alignment and consistency with the safety specifications,
pharmacovigilance planning and risk management commitments and activities.
(d) Transfer of Marketing Authorization. Zogenix shall be the marketing
authorization holder of the Product in the Territory for the [***] following
Regulatory Approval of the Product in the Territory. Thereafter, Zogenix shall
transfer the marketing authorization for the Product in the Territory to
Distributor within [***] following [***], unless delayed or prohibited by a
Regulatory Authority or Applicable Law or otherwise agreed by the Parties. Upon
the transfer of the marketing authorization of the Product in the Territory to
Distributor, then Distributor shall be deemed the MAH Party for purposes of this
Agreement and Zogenix shall be deemed the Non-MAH Party.
(e) Ownership of Regulatory Information. The Parties acknowledge and agree that
Zogenix shall retain the full unfettered ownership of the Data and drug dossier
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submitted to the PMDA for the Regulatory Approval (including but not limited to
safety & efficacy data, clinical data package, drug formulation and method of
administration). Notwithstanding the foregoing, if Zogenix asks Distributor to
solely conduct any additional Territory-specific Development activities which
are urgently required by the MHLW for the MAA in the Territory, Distributor
shall retain co-ownership with Zogenix of any Data generated solely by
Distributor. Distributor hereby grants Zogenix an irrevocable, perpetual,
royalty-free, fully paid-up, exclusive license with the right to grant
sublicenses to use such Data solely generated and co-owned by Distributor
outside of the Territory and a co-exclusive license in the Territory upon
expiration or termination of the Agreement.
(f) Regulatory Cooperation. Each Party shall cooperate in good faith with any
reasonable requests for assistance from the other Party with respect to
obtaining or maintaining Regulatory Approval of the Product in and outside the
Territory, including by providing to the other Party all Information in its
possession and Control that is requested by, or needed to respond to inquiries
of, a Regulatory Authority with respect to the Product.
4.3 Distributor’s Right to Use and Reference. Distributor shall have the right
to reference and use all Data and Regulatory Filings (including all Regulatory
Approvals) for the purpose of fulfilling Distributor’s obligations set forth in
this Agreement. For clarity, in accordance with Section 4.2(b), [***].
4.4 Zogenix’s Right to Use and Reference. In the event that Distributor is
responsible for filing for and obtaining Regulatory Approval of the Product in
the Field in the Territory or Distributor otherwise is the holder of the
Regulatory Approval for the Product in the Territory, Zogenix and its Affiliates
and Zogenix ex-Territory Distributors shall have the royalty-free right to
reference and use all Data and Regulatory Filings (including all Regulatory
Approvals), including all data contained or referenced therein, provided by or
to Distributor under this Article 4, such reference and use in connection with
filing for, obtaining and maintaining Regulatory Approval and commercializing
the Product outside the Territory and in the Territory outside the Field.
Distributor shall, on written request by Zogenix, provide, or shall cause its
applicable Affiliate to provide, to Zogenix and to any specified Regulatory
Authority a letter, in the form reasonably required by Zogenix, acknowledging
and confirming that Zogenix and its Affiliates and/or Zogenix ex-Territory
Distributors, as applicable, have the rights of reference to any such Regulatory
Filing (including any such Regulatory Approval) for all purposes consistent with
the Development, Regulatory Approval and commercialization of the Product
outside the Territory and in the Territory outside the Field. Distributor shall
not, and shall cause its Affiliates not to, transfer or disclose any Regulatory
Filings (including any Regulatory Approval) relating to the Product in the
Territory to any Third Party without the prior written consent of Zogenix, and
in any such permitted transfer Distributor shall require the transferee to
acknowledge in writing to Zogenix, Zogenix’s (and its Affiliates’ and Zogenix
ex-Territory Distributors’) rights of reference to and right to use all such
Regulatory Filings (including Regulatory Approvals) as provided in this Section
4.3.
4.5 Adverse Event Reporting. The MAH Party shall be responsible for the timely
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reporting of all relevant adverse drug reactions/experiences, Product quality,
Product complaints and safety data relating to the Product in the Field to the
appropriate Regulatory Authorities in the Territory, all in accordance with
Applicable Laws and requirements of Regulatory Authorities in the Territory.
Zogenix (or its Affiliate, or Zogenix ex-Territory Distributors) shall be
responsible for the timely reporting of all relevant adverse drug
reactions/experiences, Product quality, Product complaints and safety data
relating to the Product to the appropriate Regulatory Authorities outside the
Territory. The details of such reporting shall be set forth in a
pharmacovigilance agreement (as may be amended, the “Pharmacovigilance
Agreement”), which will be agreed to by the Parties prior to the First
Commercial Sale in the Territory. The Pharmacovigilance Agreement shall include,
without limitation, governance provisions that set forth a process for
communication and escalation, where necessary, of safety issues, label changes,
and the like. Zogenix shall have the right to share any and all information
received from Distributor under this Section 4.5, or the Pharmacovigilance
Agreement, with Zogenix’s Affiliates and Zogenix ex-Territory Distributors. The
Pharmacovigilance Agreement shall identify the responsibilities of each Party
regarding the information to be exchanged and the timeframes for such exchange,
regulatory reporting, literature review, risk management, and labeling. Prior to
executing the Pharmacovigilance Agreement, the Parties agree to work together in
good faith to coordinate regarding pharmacovigilance activities with respect to
the Product in the Field, including by exchanging Distributor’s standard
operating procedures and other Information relevant to such pharmacovigilance
activities.
4.6 Drug Safety and Pharmacovigilance System including Global Safety Database.
Zogenix shall maintain a global system for monitoring and management of the
risks associated with the Product. This system will provide signal management as
well as the collection, identification, evaluation, and management of individual
case safety reports and cumulative reports. As part of this pharmacovigilance
system, Zogenix shall maintain the global safety database with respect to the
Product, which shall serve as the reference database for all responses to safety
queries and aggregate safety reports and be the main source for individual case
safety report processing. Each Party shall cooperate, and shall cause its
Affiliates, Sub-distributors and Zogenix ex-Territory Distributors, as
applicable, to cooperate, in implementing and adhering to a pharmacovigilance
mutual alert process with respect to the Product to comply with Applicable Laws,
as set forth in the Pharmacovigilance Agreement. Notwithstanding anything to the
contrary in this Agreement, Zogenix shall have final decision making authority
over all issues that implicate global safety.
4.7 Regulatory Audit. Each Party shall notify the other Party within [***] of
receipt of any notice of a MHLW audit of any of such Party or its Affiliate or
subcontractor with respect to the Product in the Territory. Notwithstanding the
foregoing, if a Party is subject to an unannounced audit from the MHLW or
receives a notice of an imminent audit from the MHLW, in each case with respect
to the Product in the Territory, such Party shall notify the other Party
promptly, but in any event within [***]. Such other Party shall have the right
to have its or its Affiliates’ or its subcontractors’ employees or consultants
participate in any audits or other inspections to the extent permitted by
Applicable Law. To the extent permitted by Applicable Law, the audited Party
shall provide the other Party with the copies of any resulting document or
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action pertaining to the Product in the Territory that results from such audit
within [***] of their receipt.
4.8 Use of Subcontractors. To the extent that Distributor performs any of its
regulatory or commercial activities under this Agreement through one or more
subcontractors (including a Sub-distributor), if and as permitted under the
terms of this Agreement, Distributor shall ensure that (a) none of Zogenix’s
rights hereunder are diminished or otherwise adversely affected as a result of
such subcontracting, (b) the subcontractor assigns to Distributor all
Distributor Inventions and all data generated by such subcontractor that, if
Controlled by Distributor, would be included in the definition of Data, (c) the
subcontractor undertakes in writing obligations of confidentiality and non-use
regarding Confidential Information and compliance with the FCPA and other
Applicable Laws that are substantially the same as those undertaken by the
Parties pursuant to Article 8 and Section 10.2, (d) the subcontractor does not
have an adverse history or reputation, (e) the use of the subcontractor will not
cause the Zogenix Indemnitees to be in violation of the FCPA or any other
Applicable Laws, and (f) the use of the subcontractor will not cause
reputational harm to the Zogenix Indemnitees. In the event that Distributor
performs any of its regulatory activities hereunder through a subcontractor,
Distributor will at all times be fully responsible for the performance and
payment of such subcontractor.
4.9 Recalls.
(a) In the event that the MHLW issues a request or orders a recall or takes
similar action in connection with the Product in the Territory, or in the event
either Party determines that an event, incident, or circumstance has occurred
that may result in the need for a voluntary withdrawal of the Product in the
Territory, the Party notified of such recall or desiring such voluntary
withdrawal shall, within [***], advise the other Party thereof by telephone (and
confirm by electronic mail or facsimile). Regarding any recall order or request
from the MHLW, the Parties shall, to the extent practicable, discuss and
endeavor to agree upon a plan for recalling the affected Product. Regarding any
request for a voluntary withdrawal, the Parties shall discuss and endeavor to
agree upon whether to voluntarily withdraw the Product in the Territory, and
each Party shall review and consider in good faith all information provided by
the other Party in connection with such discussion, including any assessment of
safety and whether to withdraw the Product.
(b) For all recalls requested or ordered by the MHLW, the MAH Party shall have
the sole authority and responsibility to make all decisions with respect to such
recall, subject to good faith consideration of the views of the non-MAH Party.
For all voluntary withdrawals concerning quality defects, such as compliance,
foreign substances, tampering and labeling defects, the MAH Party shall have the
sole authority and responsibility to make all decisions with respect to such
withdrawal, subject to good faith consideration of the views of non-MAH party.
For all voluntary withdrawals concerning efficacy or safety, Zogenix shall have
the sole authority and responsibility to make all decisions with respect to such
withdrawal, subject to good faith consideration of the views of the Distributor.

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(c) Distributor shall be responsible for conducting any such recall or
withdrawal, shall use Commercially Reasonable Efforts to minimize the expenses
of any such recall or withdrawal and shall keep Zogenix fully informed of all
actions taken in conducting such recall or withdrawal. If a recall or withdrawal
is due to Zogenix’s negligence, willful misconduct or breach of this Agreement,
Zogenix shall reimburse Distributor for all of the reasonable costs and expenses
actually incurred by Distributor in connection with such recall or withdrawal,
including, but not limited to, costs of personnel expenses of Distributor’s
sales representatives, fees for consultation with the Regulatory Authority in
the Territory and travel expenses for consultation, and its actual reasonable
Out-of-Pocket Costs and Expenses incurred while retrieving Product already
delivered to customers, costs and expenses Distributor is required to pay for
notification, shipping and handling charges, and such other costs as may be
reasonably related to the recall or withdrawal. If a recall or withdrawal is due
to Distributor’s negligence, willful misconduct or breach of this Agreement,
Distributor shall reimburse Zogenix for all the reasonable costs and expenses
described above actually incurred by Zogenix in connection with such recall or
withdrawal, including administration of the recall and such other actual costs
as may be reasonably related to the recall or withdrawal in the Territory. If a
recall or withdrawal results from a cause other than the negligence in the
Territory, willful misconduct or breach of this Agreement of or by Distributor
or Zogenix, the parties hereto [***]. Prior to any reimbursements pursuant to
this Section, the party claiming any reimbursement shall provide the other party
with reasonably acceptable documentation of all reimbursable costs and expenses.
Neither Party will be liable to the other for Indirect Losses in connection with
any recall or withdrawal pursuant to this Section.
4.10 Development Expenses. Unless expressly stated otherwise, each Party shall
bear its own Out-of-Pocket Costs and Expenses and any employee and overhead
expenses incurred while performing its obligations under this Article 4.

ARTICLE 5.
COMMERCIALIZATION; SUPPLY: TRADEMARKS
5.1 Commercialization of the Product.
(a) Distributor Responsibilities. Distributor shall have the exclusive right to
market, promote, sell, offer for sale, import, package and otherwise
Commercialize the Product in the Field in the Territory, at its sole cost and
expense, in accordance with Applicable Laws and the Commercialization Plan and
subject to the terms and conditions of this Agreement. Without limiting the
foregoing, Distributor will have the exclusive right and responsibility in the
Field in the Territory for the following:
(i) designing the Commercialization strategy and tactics for the Product,
subject to JSC approval of the Commercialization Plan;
(ii) undertaking all promotional activities for the Product;

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(iii) establishing and implementing post-marketing surveillance studies for the
Product in the Territory as required or recommended by a Regulatory Authority;
(iv) receiving, accepting and filling orders for the Product from customers;
(v) warehousing and distributing the Product to customers;
(vi) controlling invoicing, order processing and collection of accounts
receivable for sales of the Product;
(vii) recording sales of the Product in the Territory in its books of account
for sales; and
(viii) providing results of sales of the Product in the Territory for purposes
of periodic safety reports and exposure estimates.
Distributor shall provide updates regularly to the JSC relating to
Commercialization activities for the Product in the Field in the Territory.
(b) Commercialization Plan. Distributor shall be responsible for the creation
and implementation of an annual plan for the Commercialization of the Product in
the Field in the Territory, which shall identify proposed plans to address
potential challenges with respect to Commercialization of the Product in the
Field in the Territory (the “Commercialization Plan”). The Commercialization
Plan shall set forth in reasonable detail the major Commercialization activities
planned for the Product in the Territory for the applicable period, including
[***]. Distributor shall prepare and submit to the JSC the initial
Commercialization Plan no later than [***] after MAA filing for the Product in
the Field in the Territory for review and approval by the JSC in accordance with
the decision-making procedures set forth in Section 3.1(d). Distributor shall
submit subsequent updated Commercialization Plans to the JSC on an annual basis
on or before the end of each Fiscal Year for review and approval by the JSC.
Through the JSC, Distributor shall regularly consult with and provide updates to
Zogenix regarding the Commercialization strategy for and the Commercialization
of the Product in the Field in the Territory.
(c) Diligence. During the Term, Distributor shall use Commercially Reasonable
Efforts to market, promote, sell, offer for sale, import, package, distribute
and otherwise commercialize the Product in the Field in the Territory in
accordance with the Commercialization Plan and the terms of this Agreement.
Without limiting the foregoing, Distributor shall Submit the first purchase
order of the Product in the Field in the Territory to Zogenix within [***],
achieve First Commercial Sale of the Product in the Field in the Territory as
soon as reasonably practicable after the Product is first available for delivery
to Distributor in the Territory, and use Commercially Reasonable Efforts to
timely accomplish all the activities set forth in the Commercialization Plan.

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(d) Distributor’s Diligence Failure.
(i) After [***] of the First Commercial Sale of the Product in the Territory, if
Zogenix reasonably believes that Distributor has failed to achieve or maintain
the diligence obligations set forth in Section 5.1(c), Zogenix shall provide
written notice thereof to Distributor requesting a detailed written response
concerning such failure and Distributor shall provide such detailed written
response to Zogenix within [***] of the date of Zogenix’s request. Zogenix’s
notice shall specify in reasonable detail the facts and circumstances
constituting Zogenix’s reasons for reaching such a determination. Following
Zogenix’s receipt of Distributor’s response, the Parties shall promptly, and in
any event within [***], discuss in good faith Distributor’s obligations and its
proposed actions to cure its failure to achieve its diligence obligations. Where
remedy is possible and reasonably acceptable to Zogenix, Distributor shall use
its Commercially Reasonable Efforts to start substantive steps within [***] of
the date of Zogenix’s notice to Distributor. If Distributor (A) fails to provide
a detailed written response to Zogenix within [***] of the date of Zogenix’s
notice to Distributor, or (B) fails to use its Commercially Reasonable Efforts
to start substantive steps to remedy such failure [***] of the date of Zogenix’s
notice to Distributor, Zogenix shall have the right, [***] effective upon
written notice thereof by Zogenix to Distributor, to (1) [***] or (2) [***].
(ii) Any failure of Distributor to achieve the diligence obligations set forth
in Section 5.1(c) shall not be considered Distributor’s diligence failure as
described in Section 5.1(d)(i) or a breach of this Agreement to the extent such
failure was caused by (A) Zogenix’s inability or failure to supply Product in
accordance with the terms of the Supply Agreement, (B) any changes to the
Regulatory Plan approved by the JSC in accordance with Section 4.2(a), or (C)
any changes to the Commercialization Plan approved by the JSC in accordance with
Section 5.1(b).
(iii) This Section 5.1(d) shall not limit any other remedies or damages that
Zogenix may have or seek under this Agreement or Applicable Laws.
5.2 Supply. The Parties acknowledge and agree that Zogenix shall retain all
rights to make and have made the Product in and for the Territory. Promptly
after the Effective Date, the Parties shall commence negotiating a supply
agreement containing reasonable and customary terms for an agreement of such
type, governing Zogenix’s supply of the Product to Distributor for sale in the
Field in the Territory in accordance with the terms of this Agreement (as may be
amended, the “Supply Agreement”), and shall use reasonable efforts to enter into
the Supply Agreement within [***] after the Effective Date. Zogenix shall
supply, or cause to be supplied, Product to Distributor in accordance with the
Supply Agreement, and Distributor shall purchase all of its and its Affiliates’
and Sub-distributors’ requirements for the Product under the Supply Agreement.
Distributor shall pay to Zogenix the Transfer Price for Product supplied under
the Supply Agreement in accordance with Section 6.5.

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5.3 Trademark Rights.
(a) Product Trademarks. Subject to the terms and conditions of this Agreement,
Zogenix hereby grants to Distributor an co-exclusive, royalty-free, limited
right under the Product Trademarks solely to promote, market, sell, offer for
sale, import, package and distribute the Product in Field in the Territory in
accordance with the terms of this Agreement.
(b) Zogenix Trademarks. Subject to the terms and conditions of this Agreement,
Zogenix hereby grants to Distributor a non-exclusive, royalty-free, limited
right under the Zogenix Trademarks solely to promote, market, sell, offer for
sale, import, package and distribute the Product in Field in the Territory in
accordance with the terms of this Agreement.
5.4 Commercial Expenses. Unless expressly stated otherwise, each Party shall
bear its own Out-of-Pocket Costs and Expenses and all employee and overhead
expenses incurred while performing its obligations under this Article 5.

ARTICLE 6.
PAYMENTS
6.1 Upfront Payment. Distributor shall pay to Zogenix, upon the receipt of the
invoice from Zogenix after the Effective Date, a non-refundable, non-creditable
upfront payment of Seven Million Five Hundred Thousand U.S. Dollars (US
$7,500,000), which upfront payment shall consist of [***] in consideration for
the exclusive right to distribute Product in the Territory for the treatment of
Dravet syndrome and [***] in consideration for the exclusive right to distribute
Product in the Territory for the treatment of Lennox-Gastaut syndrome.
Distributor shall pay such payment to Zogenix within [***] of receipt of the
invoice.
6.2 Funding to Support Development of The Product. Distributor shall pay to
Zogenix Twelve Million Five Hundred Thousand U.S. Dollars (US $12,500,000) for
support of Zogenix’s global nonclinical and clinical Development studies
concerning the Product for Dravet syndrome and Lennox-Gastaut syndrome as it
relates to Regulatory Approval of the Product in the Territory. For clarity, the
Six Million Five Hundred Thousand U.S. Dollar (US $6,500,000) payment is
intended to support studies previously conducted by Zogenix and that will be
included in the MAA for the Territory. The remaining Six Million U.S. Dollars
(US 6,000,000) in payments are intended to support those studies conducted by
Zogenix and indicated as being paid for by Zogenix under the initial Regulatory
Plan during [***] after the Effective Date, and such payments will be made
[***]. The five (5) Development payments pursuant to this Section 6.2 will be
made according to the following schedule:
(a) Within [***] after the Effective Date, a non-refundable, non-creditable
one-time payment of [***];
(b) Within [***] after the Effective Date, a non-refundable, non-creditable
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one-time payment of [***];
(c) On the [***] of the Effective Date, a non-refundable, non-creditable
one-time payment of [***];
(d) On the [***] of the Effective Date, a non-refundable, non-creditable
one-time payment of [***]; and
(e) On the [***] of the Effective Date, a non-refundable, non-creditable
one-time payment of [***].
For clarity, each of the foregoing payments to be made by Distributor to Zogenix
shall be payable within [***] of receipt of the invoice therefor from Zogenix.
In the event that Zogenix terminates the Development the Product in the
Territory for both Dravet syndrome and Lennox-Gastaut syndrome prior to the due
date for any of the foregoing payments any such payment whose due date is after
such termination shall no longer be due and payable to Zogenix.
6.3 Regulatory Milestones. Distributor shall pay to Zogenix the non-refundable,
non-creditable milestone payments as set forth in this Section 6.3. Upon the
occurrence of each milestone event in this Section 6.3 Zogenix shall issue an
invoice to Distributor for the amount of the milestone payment corresponding to
such achieved milestone event, and Distributor shall pay to Zogenix such
invoiced amount within [***] of its receipt from Zogenix.
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Regulatory Milestone EventMilestone
Payment[***][***][***][***][***][***][***][***][***][***][***][***][***][***][***][***]

Each milestone payment set forth above shall be payable only once for the
Product. For clarity, the total regulatory milestone payments set forth in this
Section shall not exceed: (a) [***] if [***]; (b) [***] if [***]; and (c) [***].
6.4 Sales Milestones. For each Fiscal Quarter in which aggregate annual Net
Sales first reach a threshold indicated in the table below, Distributor shall
inform Zogenix within [***] that the aggregated annual Net Sales first reached
such threshold. Zogenix shall issue an invoice to Distributor for the applicable
milestone payment, and Distributor shall pay such invoice within [***] of its
receipt from Zogenix:

Annual Net Sales LevelMilestone Payment
First Fiscal Year in which aggregate annual Net Sales of the Product in the
Field in the Territory exceed [***]
[***]
First Fiscal Year in which aggregate annual Net Sales of the Product in the
Field in the Territory exceed [***]
[***]
First Fiscal Year in which aggregate annual Net Sales of the Products in the
Field in the Territory exceed [***]
[***]

The milestone payments set forth in this Section 6.4 shall be additive, such
that if all three (3)
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milestone events are achieved in the same Fiscal Year, Distributor shall pay to
Zogenix all three (3) milestone payments.
6.5 Supply Payments.
(a) Transfer Price. During the Distribution Term, and in addition to the
consideration provided pursuant to Sections 6.1, 6.2, 6.3, and 6.4, for all
Product supplied by Zogenix to Distributor under purchase orders submitted
pursuant to the Supply Agreement in a particular Fiscal Year, Distributor shall
pay to Zogenix a transfer price per unit of Product supplied (the “Transfer
Price”) equal to the sum of (i) [***] of the Fully-Burdened Manufacturing Cost
per unit of Product for such Fiscal Year, (ii) [***] of aggregate annual Net
Sales for such Fiscal Year, and (iii) the applicable markup percent of the
applicable aggregate Net Price for such Fiscal Year, which markup percent is
determined based on the incremental amount of Product ordered in such Fiscal
Year as set forth below, as may be adjusted pursuant to Section 6.5(b):

Amount of Product Supplied per Fiscal YearNet Price Markup
For the portion of Product supplied less than or equal to the equivalent of
[***] in Net Sales in such Fiscal Year
[***]
For the portion of Product supplied in excess of the equivalent of [***] in Net
Sales and less than or equal to the equivalent of [***] in Net Sales in such
Fiscal Year
[***]
For the portion of Product supplied in excess of the equivalent of [***] in Net
Sales and less than or equal to the equivalent of [***] in Net Sales in such
Fiscal Year
[***]
For the portion of Product supplied in excess of the equivalent of [***] in Net
Sales in such Fiscal Year
[***]

The Net Sales equivalent described in the left column of the table above is
calculated by determining the total number of units ordered in the applicable
Fiscal Year and multiplying such number by the Net Price for such Fiscal Year.
Following the expiration of the Distribution Term and during the remaining Term
of this Agreement, for all Product supplied by Zogenix to Distributor under
purchase orders submitted pursuant to the Supply Agreement in a particular
Fiscal Year, Distributor shall pay to Zogenix the Transfer Price per unit of
Product supplied shall be equal to the sum of (i) [***] of the Fully-Burdened
Manufacturing Cost per unit of Product for such Fiscal Year, and (ii) [***] of
aggregate annual Net Sales for such Fiscal Year.
(b) Estimates. No later than [***] before the beginning of each Fiscal Year,
starting with the Fiscal Year in which the First Commercial Sale is anticipated
to occur, the Parties shall discuss in good faith and agree on a reasonable
estimate of the Net Price for the Product for such Fiscal Year, which estimate
will be based on a reasonable approximation of the aggregate Net Sales of
Product to be recognized by Distributor and its Affiliates during such Fiscal
Year. The agreed Net Price will be used to calculate the Transfer Price
initially invoiced by Zogenix and payable by Distributor for the total number of
units of the Product ordered by
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and delivered to Distributor under the Supply Agreement during such Fiscal Year.
(c) Reports. Within [***] after the end of each of the first three Fiscal
Quarters in a Fiscal Year, starting with the Fiscal Quarter in which the First
Commercial Sale occurs, Distributor shall deliver to Zogenix a report setting
forth: (i) the total Net Sales of the Product in the Territory during such
Fiscal Quarter, (ii) the detailed and total deductions from gross amounts
invoiced to arrive at such Net Sales, (iii) the number of units of the Product
sold in the Territory during such Fiscal Quarter and (iv) gross amounts invoiced
for such sales. Within [***] after the end of each Fiscal Year, starting with
the Fiscal Year in which the First Commercial Sale occurs, Distributor shall
deliver to Zogenix a report setting forth: (A) the total Net Sales of the
Product in the Territory during such Fiscal Year, (B) the detailed and total
deductions from gross amounts invoiced to arrive at such Net Sales, (C) the
number of units of the Product sold in the Territory during such Fiscal Year,
(D) the gross amounts invoiced for such sales, (E) the calculation of actual Net
Price for such Fiscal Year, (F) the total amount invoiced by Zogenix and paid by
Distributor to Zogenix under the Supply Agreement for the total number of units
of the Product ordered by and delivered to Distributor during such Fiscal Year,
based on the estimated Net Price for such Fiscal Year, (G) the total amount
actually owed to Zogenix for the total number of units of the Product ordered by
and delivered to Distributor during such Fiscal Year based on the actual Net
Price and (H) the difference between the amounts in clauses (F) and (G) (each
such report, an “Annual Report”).
(d) True-Up. For each Annual Report, if the amount in clause (G) of such Annual
Report exceeds the amount in clause (F), then Distributor shall pay the amount
in clause (H) to Zogenix concurrently with its delivery of such Annual Report to
Zogenix. Otherwise, if the amount in clause (G) is less than the amount in
clause (F), the amount in clause (H) will be credited against the subsequent
payment(s) due from Distributor to Zogenix (or if no further payments will be
due, paid by Zogenix to Distributor within [***] after Zogenix’s receipt of such
Annual Report from Distributor). In no event shall the effective Transfer Price
for the Product in a Fiscal Year exceed [***] of the aggregate annual Net Sales
of the Product in the Field in the Territory for such Fiscal Year.

ARTICLE 7.
PAYMENTS, BOOKS AND RECORDS
7.1 Payment Method. All amounts specified to be payable under this Agreement are
in United States dollars and shall be paid in United States dollars. All
payments under this Agreement shall be made by bank wire transfer in immediately
available funds to an account designated in writing by the payee Party or by
such other means as directed by such Party in writing. Payments hereunder will
be considered to be made as of the day on which they are received by the payee
Party’s designated bank.

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7.2 Currency Conversion. For the purpose of calculating any sums due under this
Agreement and determining the annual Net Sales levels in Section 6.5, conversion
shall be made to U.S. dollars by using the arithmetic mean of the exchange rates
for the purchase of United States dollars as published in The Wall Street
Journal, Eastern Edition, for each Business Day in the Fiscal Quarter to which
such calculations relate.
7.3 Taxes. Any taxes imposed on Distributor or with respect to Distributor’s
business operations or activities hereunder, including any value added taxes,
consumption, transfer, sales, use or other such taxes relating to the
transactions contemplated herein, shall be borne by Distributor, and Distributor
shall timely pay, and indemnify and hold harmless, Zogenix from and against all
such taxes, including any penalties or interest associated therewith. If
Distributor is required by Applicable Law to deduct and withhold taxes from a
payment due and payable to Zogenix hereunder (excluding national, state or local
taxes based on income to Zogenix), Distributor shall: (a) promptly notify
Zogenix of such requirement; (b) make such required deduction and withholding
from the corresponding payment; (c) pay to the relevant Governmental Authority
the full amount required to be so deducted and withheld; and (d) promptly
forward to Zogenix an official receipt or other documentation reasonably
acceptable to Zogenix evidencing such payment to such Governmental
Authority(ies). The Parties acknowledge and agree that it is their mutual
objective and intent to minimize, to the extent feasible under the Applicable
Laws, any taxes payable in connection with this Agreement, and shall reasonably
cooperate each other in good faith in accordance with Applicable Laws to
minimize any Taxes in connection with this Agreement, including provision of any
tax forms and other information that may be reasonably necessary in order for
the paying Party not to withhold tax or to withhold tax at a reduced rate under
an applicable bilateral income tax treaty.
7.4 Records. Distributor shall keep, and require its Affiliate and
Sub-distributors to keep, complete, fair and true books of accounts and records
for the purpose of (a) determining the amounts payable to Zogenix pursuant to
this Agreement and the Supply Agreement and (b) ensuring that Distributor and
its Affiliates and Sub-distributors do not otherwise cause any Zogenix
Indemnitees to be in violation of the FCPA or other Applicable Laws. Such books
and records shall be kept for such period of time required by Applicable Laws,
but no less than three (3) years following the end of the Fiscal Year to which
they pertain. Such records shall be subject to inspection in accordance with
Section 7.5.
7.5 Audits. Upon reasonable prior written notice, Distributor shall permit an
independent, certified public accountant selected by Zogenix and reasonably
acceptable to Distributor, which acceptance will not be unreasonably withheld or
delayed, to audit or inspect those books or records of Distributor and its
Affiliates and Sub-distributors that relate to Net Sales for the sole purpose of
verifying: (a) the payments due hereunder and payments due under the Supply
Agreement; (b) the withholding taxes, if any, required by Applicable Laws to be
withheld; and (c) Distributor’s compliance with Sections 10.1 and 10.2. Such
accountant will disclose to Zogenix only the amount and accuracy of payments
reported and actually paid or otherwise payable under this Agreement or the
Supply Agreement, and will send a copy of the report to Distributor at the same
time it is sent to Zogenix. Prompt adjustments (including
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interest under Section 7.6 for underpaid amounts) shall be made by the Parties
to reflect the results of such audit. Such inspections may be made no more than
once each Fiscal Year (unless an audit or inspection reveals a material
inaccuracy in reports made under this Agreement, in which case it may be
repeated within such Fiscal Year), and during normal business hours, with
reasonable efforts to minimize disruption of Distributor’s normal business
activities. Inspections conducted under this Section 7.5 shall be at the expense
of Zogenix, unless a variation or error producing an underpayment in amounts
payable exceeding [***] of the amount paid for a period covered by the
inspection is established, in which case all reasonable costs relating to the
inspection for such period shall be paid by Distributor. Absent manifest error,
the accountant’s report will be final and binding on the Parties.
7.6 Late Payments. In the event that any payment due under this Agreement or the
Supply Agreement is not made when due, the payment shall accrue interest from
the date due at a rate per annum equal to [***] above the U.S. Prime Rate (as
set forth in The Wall Street Journal, Eastern U.S. Edition) for the date on
which payment was due, calculated daily on the basis of a 365-day year, or
similar reputable data source; provided that in no event shall such rate exceed
the maximum legal annual interest rate. The payment of such interest shall not
limit a Party from exercising any other rights it may have as a consequence of
the lateness of any payment.

ARTICLE 8.
CONFIDENTIALITY
8.1 Confidential Information. Except to the extent expressly authorized by this
Agreement or otherwise agreed in writing by the Parties, the Parties agree that
during the Term and for [***] thereafter, the receiving Party (the “Receiving
Party”) shall keep confidential and shall not publish or otherwise disclose or
use for any purpose other than as provided for in this Agreement or the Supply
Agreement any Information or materials furnished to it or its Affiliates by or
on behalf of the other Party (the “Disclosing Party”) or its Affiliates pursuant
to this Agreement, the Supply Agreement, the Confidentiality Agreement or any
other written agreement between the Parties or their Affiliates, in any form
(written, oral, photographic, electronic, magnetic, or otherwise), including all
information concerning the Product and any other technical or business
information of whatever nature (collectively, “Confidential Information” of the
Disclosing Party). All Zogenix Technology (including, without limitation, all
Product Inventions and Data) shall be deemed the Confidential Information of
Zogenix. Distributor Inventions shall be deemed the Confidential Information of
Distributor. Joint Inventions shall be deemed the Confidential Information of
each of Zogenix and Distributor. Each Party may use the Confidential Information
of the other Party only to the extent required to accomplish the purposes of
this Agreement or the Supply Agreement (including to exercise its rights or
fulfill its obligations under this Agreement or the Supply Agreement). Each
Party will use at least the same standard of care as it uses to protect
proprietary or confidential information of its own (but in no event less than
reasonable care) to ensure that its employees, agents, consultants and other
representatives do not disclose or make any unauthorized use of the
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Confidential Information of the other Party. Each Party will promptly notify the
other upon discovery of any unauthorized use or disclosure of the Confidential
Information of the other Party.
8.2 Exceptions. Notwithstanding Section 8.1 above, the obligations of
confidentiality and non‑use shall not apply to information that the Receiving
Party can prove by competent written evidence: (a) is now, or hereafter becomes,
through no act or failure to act on the part of the Receiving Party or any of
its Affiliates, generally known or available; (b) is known by the Receiving
Party or any of its Affiliates, other than under an obligation of
confidentiality to the Disclosing Party, at the time of receiving such
information; (c) is hereafter lawfully furnished to the Receiving Party or any
of its Affiliates by a Third Party, which Third Party did not receive such
information directly or indirectly from the Disclosing Party under an obligation
of confidence; (d) is independently discovered or developed by the Receiving
Party or any of its Affiliates without the use of Confidential Information
belonging to the Disclosing Party; or (e) is the subject of a written permission
to disclose provided by the Disclosing Party.
8.3 Permitted Disclosures. Notwithstanding the provisions of Section 8.1, the
Receiving Party may disclose Confidential Information of the Disclosing Party as
expressly permitted by this Agreement or if and to the extent such disclosure is
reasonably necessary in the following instances:
(a) filing or prosecuting Patents as permitted by this Agreement;
(b) prosecuting or defending litigation as permitted by this Agreement;
(c) complying with applicable court orders, governmental regulations, applicable
subpoenas or reasonable requests issued by governmental authorities in relation
to compliance with the FCPA and other Applicable Laws;
(d) in the case of Zogenix, disclosure under terms of confidentiality no less
stringent than under this Agreement to potential or actual Zogenix ex-Territory
Distributors;
(e) disclosure to its and its Affiliates’ contractors, employees and
consultants, in each case who need to know such information for filing for,
obtaining and maintaining Regulatory Approvals and Commercialization of Product
in the Territory in accordance with this Agreement and manufacturing and
supplying of Product in accordance with the Supply Agreement (or, in the case of
disclosures by Zogenix, who need to know such information for the Development,
manufacture and commercialization of the Product outside the Field or
Territory), on the condition that any such Third Parties agree to be bound by
confidentiality and non-use obligations that are no less stringent than those
confidentiality and non-use provisions contained in this Agreement; and
(f) disclosure to Third Parties in connection with due diligence or similar
investigations by such Third Parties, and disclosure to potential Third Party
investors in confidential financing documents, provided, in each case, that any
such Third Party agrees to be
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bound by confidentiality and non-use obligations that are no less stringent than
those confidentiality and non-use provisions contained in this Agreement.
Notwithstanding the foregoing, in the event a Party is required to make a
disclosure of the other Party’s Confidential Information pursuant to
Section 8.3(b) or (c), it will, except where impracticable, give reasonable
advance notice to the other Party of such disclosure and use efforts to secure
confidential treatment of such information at least as diligent as such Party
would use to protect its own confidential information, but in no event less than
reasonable efforts. In any event, the Parties agree to take all reasonable
action to avoid disclosure of Confidential Information hereunder.
8.4 Confidentiality of this Agreement and its Terms. Except as otherwise
provided in this Article 8, each Party agrees not to disclose to any Third Party
the existence of this Agreement or the terms of this Agreement without the prior
written consent of the other Party, except that each Party may disclose the
terms of this Agreement that are not otherwise made public as contemplated by
Section 8.5 as permitted under Section 8.3.
8.5 Public Announcements.
(a) As soon as practicable following the Effective Date, the Parties may each
issue a press release in English and/or Japanese, in the form attached hereto as
Exhibit 8.5(a), announcing the existence of this Agreement. Except as required
by Applicable Laws (including disclosure requirements of the SEC or any stock
exchange on which securities issued by a Party or its Affiliates are traded),
neither Party shall make any other public announcement concerning this Agreement
or the subject matter hereof without the prior written consent of the other,
which shall not be unreasonably withheld or delayed; provided that each Party
may make any public statement in response to questions by the press, analysts,
investors or those attending industry conferences or financial analyst calls, or
issue press releases, so long as any such public statement or press release is
not inconsistent with prior public disclosures or public statements approved by
the other Party pursuant to this Section 8.5 and does not reveal non‑public
information about the other Party; and provided further that Zogenix may make
public statements regarding the results of Development and Commercialization
activities in the Territory. In the event of a public announcement required by
Applicable Laws, to the extent practicable under the circumstances, the Party
making such announcement shall provide the other Party with a copy of the
proposed text of such announcement sufficiently in advance of the scheduled
release to afford such other Party a reasonable opportunity to review and
comment upon the proposed text.
(b) The Parties will coordinate in advance with each other in connection with
the filing of this Agreement (including redaction of certain provisions of this
Agreement) with the SEC or any stock exchange on which securities issued by a
Party or its Affiliate are traded, and each Party will use reasonable efforts to
seek confidential treatment for the terms proposed to be redacted; provided that
each Party will ultimately retain control over what information to disclose to
the SEC or other applicable government body, and provided further that the
Parties will use their reasonable efforts to file redacted versions with any
governing bodies which are consistent with redacted versions previously filed
with any other governing bodies. Other than
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such obligation, neither Party (nor its Affiliates) will be obligated to consult
with or obtain approval from the other Party with respect to any filings to the
SEC or any other government body governing a stock exchange.
(c) Except as expressly permitted in this Agreement or as required by Applicable
Laws, neither Party may use the other Party’s trademarks, service marks or trade
names, or otherwise refer to or identify that other Party in marketing or
promotional materials, press releases, statements to news media or other public
announcements, without the other Party’s prior written consent, which that other
Party may grant or withhold in its sole discretion.
8.6 Publication. At least [***] prior to Distributor or its Affiliates or
Sub-distributors publishing, publicly presenting, and/or submitting for written
or oral publication a manuscript, presentation, abstract, marketing document or
the like that includes Information relating to the Product that has not been
previously published, Distributor shall provide to Zogenix’s Alliance Manager a
draft copy thereof for Zogenix’s review (unless Distributor is required by
Applicable Laws to publish such Information sooner, in which case Distributor
shall provide such draft copy to Zogenix’s Alliance Manager as much in advance
of such publication as possible). Distributor shall consider in good faith any
comments provided by Zogenix during such [***] period, and in the event that
Zogenix raises any concerns the matter shall be raised at the JSC; provided that
Distributor shall, at Zogenix’s reasonable request, cease such proposed
publication or remove therefrom any information requested by Zogenix. The
contribution of each Party shall be noted in all publications or presentations
by acknowledgment or co-authorship, whichever is appropriate.
8.7 Prior Non-Disclosure Agreements. As of the Effective Date, the terms of this
Article 8 shall supersede any prior non-disclosure, secrecy or confidentiality
agreement between the Parties (or their Affiliates) dealing with the subject of
this Agreement, including the Confidentiality Agreement, but excluding any terms
of the Supply Agreement. Any information disclosed under such prior agreements
shall be deemed disclosed under this Agreement.
8.8 Equitable Relief. Given the nature and value of the Confidential Information
and the competitive damage and irreparable harm that would result to a Party
upon unauthorized disclosure, use or transfer of its Confidential Information to
any Third Party, the Parties agree that monetary damages may not be a sufficient
remedy for any breach of this Article 8. If the Receiving Party becomes aware of
any breach or threatened breach of this Article 8 by the Receiving Party or a
Third Party to whom the Receiving Party disclosed the Disclosing Party’s
Confidential Information, the Receiving Party promptly shall notify the
Disclosing Party and cooperate with the Disclosing Party to regain possession of
its Confidential Information and prevent any further breach. In addition to all
other remedies, a Party shall be entitled to seek specific performance and
injunctive and other equitable relief as a remedy for any breach or threatened
breach of this Article 8 without furnishing proof of actual damages or posting a
bond.

ARTICLE 9.

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INTELLECTUAL PROPERTY OWNERSHIP AND ENFORCEMENT
9.1 Ownership of Intellectual Property.
(a) Zogenix Technology. Zogenix shall retain all right, title and interest in
and to the Zogenix Technology.
(b) Inventions and Intellectual Property Rights.
(i) Ownership. Zogenix shall own the entire right, title and interest in and to
any and all Inventions discovered, developed, identified, made, conceived or
reduced to practice solely by or on behalf of Zogenix under or in connection
with this Agreement, including in the course of conducting regulatory activities
or Commercialization of the Product in the Field in the Territory, whether or
not patented or patentable, together with any and all intellectual property
rights in any such Inventions, including Patents that claim or disclose any such
Inventions (collectively, the “Product Invention”). Distributor shall own the
entire right, title and interest in and to any and all Inventions discovered,
developed, identified, made, conceived or reduced to practice solely by
Distributor or its Affiliates or Sub-distributors or its other subcontractors in
the Territory and under or in connection with this Agreement, including in the
course of conducting regulatory activities or Commercialization of the Product
in the Field in the Territory, whether or not patented or patentable, together
with any and all intellectual property rights in any such Inventions, including
Patents that claim or disclose any such Inventions (collectively, the
“Distributor Invention”). Zogenix and Distributor shall each own an undivided
right, title, and interest in and to any and all Inventions discovered,
developed, identified, made, conceived or reduced to practice jointly by or on
behalf of Zogenix under or in connection with this Agreement and by Distributor
or its Affiliates or Sub-distributors or its other subcontractors in the
Territory and under or in connection with this Agreement (“Joint Invention”). In
the event that either Zogenix or Distributor intends to file a patent
application containing a Joint Invention, such Party shall promptly notify the
other Party of such intention and shall provide a draft of any such patent
application to such other Party [***] before filing such patent application with
any patent office and the Parties shall negotiate in good faith concerning the
terms and conditions of a joint patent agreement.
(ii) Disclosure, License. Distributor shall, and shall cause its Affiliates and
Sub-distributors and other subcontractors to, promptly disclose any Distributor
Inventions to Zogenix in writing promptly following its discovery, development,
identification, making, conception or reduction to practice by the Distributor,
its Affiliates, Sub-distributors or other subcontractors. Distributor hereby
grants Zogenix an irrevocable, perpetual, world-wide, royalty-free, fully
paid-up, non-exclusive license with the right to grant sublicenses under such
Distributor Inventions and any patents or patent applications claiming or
disclosing such Distributor Inventions. In the event that Distributor intends to
file a patent application containing Distributor Inventions, Distributor shall
promptly notify Zogenix of such intention and shall provide a draft of any such
patent application to Zogenix at least [***] before filing such patent
application with any patent office. Distributor shall have the sole right to
file for patent protection for such Distributor Inventions only if Zogenix does
not provide a written objection
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within [***] of being provided with a draft of such patent application.
(c) Personnel Obligations. Prior to receiving any Confidential Information or
beginning work under this Agreement, Distributor shall ensure that each
employee, agent or contractor of Distributor or its Affiliates or
Sub-distributors shall be bound in writing by non-disclosure and Invention
assignment obligations that are consistent with the obligations of the Parties
in Article 8 and this Article 9, including obligations to: (a) promptly report
any invention, discovery, process or other intellectual property right; (b)
assign to Distributor or Zogenix all of his, her or its right, title and
interest in and to any invention, discovery, process or other intellectual
property right; (c) cooperate in the preparation, filing, prosecution,
maintenance and enforcement of any patent and patent application; (d) perform
all acts and sign, execute, acknowledge and deliver any and all documents
required for effecting the obligations and purposes of this Agreement; and (e)
abide by the obligations of confidentiality and non-use set forth in Article 8.
It is understood and agreed that such non-disclosure and invention assignment
agreements need not reference or be specific to this Agreement.
9.2 Zogenix Patent Prosecution and Maintenance. During the term of this
Agreement, Zogenix shall use Commercially Reasonable Efforts to prepare, file,
prosecute (including any reissues, re-examinations, post-grant proceedings,
requests for patent term extensions, interferences, and defense of oppositions),
at Zogenix’s sole discretion and cost. If there is any material change in
Zogenix Patents specified in Exhibit 1.74, Zogenix shall provide Distributor
with updated information concerning the Zogenix Patent in a timely manner.
9.3 Infringement by Third Parties.
(a) Notice. In the event that either Zogenix or Distributor becomes aware of any
infringement or threatened infringement by a Third Party in the Territory of any
Zogenix Patents, it shall notify the other Party in writing to that effect. Any
such notice shall include evidence to support an allegation of infringement or
threatened infringement by such Third Party.
(b) Control of Action. Each Party shall share with the other Party all
information available to it regarding such alleged or threatened infringement by
a Third Party. Zogenix shall have the sole right, but not the obligation, to
bring and control any action or proceeding with respect to alleged or threatened
infringement by a Third Party in the Territory of any Zogenix Patent at
Zogenix’s cost and expense. If Zogenix elects to commence a suit to enforce the
applicable Zogenix Patent against such infringements, then Distributor shall
have the right to join such enforcement action, if permitted by Applicable Law,
upon notice to Zogenix and be represented by a counsel of its own choice at its
own cost and expense. Zogenix shall keep Distributor reasonably informed of any
such actions or proceedings and consider in good faith any comments or requests
made by Distributor, and the Parties shall cooperate and consult with each other
in strategizing regarding any such action or proceeding, provided that Zogenix
shall control and have the right to make all final decisions (regardless of
whether or not Distributor is a party to such action or proceeding) regarding
all matters in the preparation and conduct of any such action or proceeding.
Each Party shall cooperate fully with the other Party with respect to actions or
proceedings under this Section 9.3, including being joined as a party
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plaintiff in any such action or proceeding and providing access to relevant
documents and other evidence and making its employees available at reasonable
business hours, with the costs of such cooperation to be included as shared
costs for actions or proceedings brought hereunder.
(c) Recoveries. Any monetary recovery resulting from actions or proceedings
under this Section 9.3 will be allocated as follows: each of Distributor and
Zogenix first will be reimbursed, out of such recovery, for its reasonable and
verifiable costs and expenses with respect to such action or proceeding (such
reimbursement to be pro-rata based on the Parties’ relative costs and expenses
if the recovery is not sufficient to reimburse both Parties fully) with any
remainder being (i) allocated [***] if[***] or (ii) allocated [***] if [***].
9.4 Third Party Intellectual Property Rights.
(a) If either Party becomes aware of a Patent in the Territory owned by a Third
Party that it believes will, or may, be infringed by the manufacture,
importation, Development or Commercialization of the Product in the Field in the
Territory as contemplated by this Agreement, such Party shall notify the other
Party of such Patent. The Parties then shall discuss the matter and seek in good
faith to agree on whether the Parties should take a license under such Patent,
and if so, on what terms; provided, that if the Parties are unable to agree
after a reasonable period, [***], of good faith discussions, then Zogenix shall
have the right to obtain such a license on such terms as it determines in its
sole discretion and at its own cost and expense. Provided, however, in the event
that Zogenix elects not to seek or fails to obtain a license under such Patent,
Distributor shall have the right to obtain such a license with prior written
notice to Zogenix.
(b) Each Party shall promptly notify the other Party in writing of any
allegation by a Third Party that the activity of either Party pursuant to this
Agreement or the Supply Agreement infringes or may infringe the intellectual
property rights of such Third Party. Zogenix shall have the sole right to
control any defense of any such claim involving alleged infringement of Third
Party rights, at Zogenix’s sole cost and expense and by counsel of its own
choice; provided however that Distributor may participate in the defense, at its
own expense, to be represented in any such action by counsel of its own choice.
In any event, Zogenix agrees to keep Distributor reasonably informed of all
material developments in connection with any such action. Zogenix agrees not to
settle such infringement or make any admissions or assert any position in such
action in a manner that would materially adversely affect the rights or interest
of Distributor, without the prior written consent of Distributor, which shall
not be unreasonably withheld, delayed or conditioned. Neither Party shall enter
into any settlement or compromise of any action under this Section 9.4 which
would in any manner alter, diminish, or be in derogation of the other Party’s
rights under this Agreement without the prior written consent of such other
Party, which shall not be unreasonably withheld, delayed or conditioned.
9.5 Patent Term Restoration. At the request of Zogenix, the Parties shall
cooperate with each other in obtaining patent term restoration, extensions
and/or any other extensions of the Zogenix Patents as available under Applicable
Laws, subject to Zogenix’s rights under Section 9.2. Zogenix shall bear the cost
for such patent term restoration and/or any other
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extensions of the Zogenix Patent.
9.6 Patent Marking. Distributor shall, and shall require its Affiliates and
Sub-distributors to, mark all Product sold in the Territory (in a reasonable
manner consistent with industry custom and practice and Applicable Law) with
appropriate patent numbers or indicia to the extent permitted by Applicable
Laws, if such markings impact recoveries of damages or equitable remedies
available with respect to infringements of patents.
9.7 Zogenix Trademarks. All packaging, promotional materials, package inserts,
and labeling for the Product in the Field in the Territory shall bear, free of
charge, one or more house Trademarks chosen and owned by Zogenix, including the
Zogenix name and logo set forth in Exhibit 9.7 (each, a “Zogenix Trademark”).
Zogenix or its Affiliates shall own all right, title, and interest in and to all
Zogenix Trademarks, all corresponding trademark applications and registrations
thereof, and all common law rights thereto. Zogenix shall, at Zogenix’s sole
expense, have sole control over the registration, prosecution, maintenance,
enforcement and defense of the Zogenix Trademarks. All goodwill of the business
associated with or symbolized by the Zogenix Trademarks shall inure to the
benefit of Zogenix. Distributor acknowledges Zogenix’s exclusive ownership of
the Zogenix Trademarks and agrees not to take any action inconsistent with such
ownership. Distributor shall provide Zogenix with samples of any advertising and
promotional materials in original language that incorporate the Zogenix
Trademarks prior to distributing such materials for use. Distributor shall
comply with reasonable policies provided by Zogenix from time to time to
maintain the goodwill and value of the Zogenix Trademarks. Distributor shall
not, and shall cause its Affiliates not to, (i) use, seek to register, or
otherwise claim rights in any Trademark that is confusingly similar to,
misleading or deceptive with respect to, or that materially dilutes, any of the
Zogenix Trademarks, or (ii) knowingly do, cause to be done, or knowingly omit to
do any act, the doing, causing or omitting of which endangers, undermines,
impairs, destroys or similarly affects, in any material respect, the validity or
strength of any of the Zogenix Trademarks (including any registration or pending
registration application relating thereto) or the value of the goodwill
pertaining to any of the Zogenix Trademarks.
9.8 Product Trademarks.
(a) Selection and Ownership of Product Trademarks. All packaging, promotional
materials, package inserts, and labeling for the Product in the Field in the
Territory shall bear one or more Trademarks that pertain specifically to the
Product, including the Trademarks in existence as of the Effective Date as set
forth in Exhibit 9.8 (each, a “Product Trademark”). If the Product Trademarks in
existence as of the Effective Date are not eligible for trademark protection or
for use in connection with the Product in the Field in the Territory or if the
Parties agree that alternative or additional Trademarks may be beneficial,
Distributor may investigate appropriate Trademarks for the Product in the
Territory. If the Parties identify and agree on alternative or additional
Trademarks for the Product in the Territory, Zogenix shall use Commercially
Reasonable Efforts to register such Trademark(s) for the Product in the Field in
the Territory. Zogenix or its Affiliates shall own all right, title, and
interest in and to all Product
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Trademarks, all corresponding trademark applications and registrations thereof,
and all common law rights thereto. All goodwill of the business associated with
or symbolized by the Product Trademarks shall inure to the benefit of Zogenix.
Distributor acknowledges Zogenix’s exclusive ownership of the Product Trademarks
and agrees not to take any action inconsistent with such ownership.
(b) Maintenance and Prosecution of Product Trademarks. Zogenix shall, at
Zogenix’s sole expense, control the registration, prosecution and maintenance of
the Product Trademarks in the Territory; provided, that Zogenix shall keep
Distributor reasonably informed of Zogenix’s actions with respect thereto and
shall consider in good faith any reasonable comments made by Distributor with
respect thereto.
(c) Use of Product Trademarks. Distributor shall promote, market, sell, offer
for sale, import, distribute and otherwise commercialize the Product in the
Field in the Territory only under the Product Trademarks. Distributor shall
provide Zogenix with samples of any advertising and promotional materials that
incorporate the Product Trademarks prior to distributing such materials for use.
Distributor shall comply with reasonable policies provided by Zogenix from time
to time to maintain the goodwill and value of the Product Trademarks.
Distributor shall not, and shall cause its Affiliates not to, (i) use, seek to
register, or otherwise claim rights in the Territory in any Trademark that is
confusingly similar to, misleading or deceptive with respect to, or that
materially dilutes, any of the Product Trademarks, or (ii) knowingly do, cause
to be done, or knowingly omit to do any act, the doing, causing or omitting of
which endangers, undermines, impairs, destroys or similarly affects, in any
material respect, the validity or strength of any of the Product Trademarks
(including any registration or pending registration application relating
thereto) or the value of the goodwill pertaining to any of the Product
Trademarks.
(d) Enforcement of Product Trademarks. Zogenix shall have the first right, but
not the obligation, at Zogenix’s expense, to enforce and defend the Product
Trademarks in the Territory, including (i) defending against any alleged,
threatened or actual claim by a Third Party that the use of the Product
Trademarks in the Territory infringes, dilutes or misappropriates any Trademark
of that Third Party or constitutes unfair trade practices, or any other claims
that may be brought by a Third Party against a Party in connection with the use
of or relating to Product Trademarks in the Territory with respect to the
Product and (ii) taking such action as Zogenix deems necessary against a Third
Party based on any alleged, threatened or actual infringement, dilution or
misappropriation of, or unfair trade practices or any other like offense
relating to, the Product Trademarks in the Territory by a Third Party. If
Zogenix elects not to enforce or defend the Product Trademarks in any such
instance, then Zogenix shall promptly so notify Distributor and Distributor
shall have the right, but not the obligation, at its expense, to do so. Each
Party shall provide to the other Party all reasonable assistance requested by
such first Party in connection with any such action, claim or suit under this
Section 9.8(d), including allowing such first Party access to such other Party’s
documents and to such other Party’s personnel who may have possession of
relevant information.

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(e) Distributor’s Housemarks. In addition to the Product Trademarks, Distributor
shall have the right to brand the Product in the Territory with those trademarks
of Distributor that are associated with Distributor’s name or identity and are
pre-approved in writing by Zogenix (“Distributor Housemarks”). Distributor shall
own all rights in the Distributor Housemarks, and all goodwill in the
Distributor Housemarks shall accrue to Distributor. Distributor and its
Affiliates and Sub-distributor shall not use any trademarks, other than the
Zogenix Trademarks, Product Trademarks and the approved Distributor Housemarks,
in connection with the Commercialization of the Product in the Field in the
Territory, without the prior written consent of Zogenix.

ARTICLE 10.
REPRESENTATIONS, WARRANTIES AND COVENANTS;
LIMITATION OF LIABILITY
10.1 Mutual Representations, Warranties and Covenants. Each Party hereby
represents and warrants to the other Party, as of the Effective Date, as
follows:
(a) Duly Organized. Such Party is a corporation duly organized, validly existing
and in good standing under the laws of the jurisdiction of its incorporation, is
qualified to do business and is in good standing as a foreign corporation in
each jurisdiction in which the conduct of its business or the ownership of its
properties requires such qualification and failure to have such would prevent
such Party from performing its obligations under this Agreement.
(b) Due Authorization; Binding Agreement. The execution, delivery and
performance of this Agreement by such Party have been duly authorized by all
necessary corporate action. This Agreement is a legal and valid obligation
binding on such Party and enforceable in accordance with its terms and does not:
(i) to such Party’s knowledge and belief, violate any law, rule, regulation,
order, writ, judgment, decree, determination or award of any court, governmental
body or administrative or other agency having jurisdiction over such Party; nor
(ii) conflict with, or constitute a default under, any agreement, instrument or
understanding, oral or written, to which such Party is a party or by which it is
bound.
(c) Consents. Such Party has obtained, or is not required to obtain, the
consent, approval, order or authorization of any Third Party, or has completed,
or is not required to complete, any registration, qualification, designation,
declaration or filing with any Regulatory Authority or governmental authority in
connection with the execution and delivery of this Agreement and the performance
by such Party of its obligations under this Agreement.
(d) No Conflicting Grant of Rights. Such Party has the right to grant the rights
contemplated under this Agreement and has not, and will not during the Term,
grant any right to any Third Party that would conflict with the rights granted
to the other Party hereunder.
(e) Debarment. Such Party is not debarred or disqualified under the United
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States Federal Food, Drug and Cosmetic Act or comparable Applicable Laws in the
Territory and it does not, and will not during the Term, employ or use the
services of any Person who is debarred or disqualified, in connection with
activities relating to the Product. In the event that either Party becomes aware
of the debarment or disqualification or threatened debarment or disqualification
of any Person providing services to such Party, including the Party itself and
its Affiliates or Sub-distributors, that directly or indirectly relate to
activities under this Agreement, such Party shall immediately notify the other
Party and shall cease employing, contracting with, or retaining any such person
to perform any services under this Agreement.
(f) Comply with Applicable Laws. In the performance of its obligations
hereunder, such Party shall comply and shall cause its and its Affiliates’
employees and contractors to comply with all Applicable Laws.
(g) Anti-Corruption.  Such Party shall not, directly or indirectly through Third
Parties, pay, promise or offer to pay, or authorize the payment of, any money or
give any promise or offer to give, or authorize the giving of anything of value
to a Public Official or Entity or other Person for purpose of obtaining or
retaining business for or with, or directing business to, any Person, including,
without limitation, Zogenix or Distributor. Without any limitation to the
foregoing, such Party has not and shall not directly or indirectly promise,
offer or provide any corrupt payment, gratuity, emolument, bribe, kickback,
illicit gift or hospitality or other illegal or unethical benefit to a Public
Official or Entity or any other Person.
(h) Accuracy of Materials. All due diligence materials that such Party has
provided and will provide to the other Party were and will be to the knowledge
of such Party accurate, truthful, and complete at the time such materials are
provided to the other Party, and such Party has not and will not intentionally
omit any material facts requested by the other Party.
(i) Notification for Violation of Applicable Laws. Such Party shall immediately
notify the other Party if it has any information or suspicion that there may be
a violation of the FCPA or any other Applicable Law in connection with the
performance of this Agreement or the sale of the Product in the Territory.
(j) No Pubic Officials. No owner, shareholder (direct or beneficial), officer,
director, employee, third-party representative, agent, or other individual with
any direct or indirect beneficial interest in such Party or its Affiliates or,
to its knowledge, in its Sub-distributors or other contractors, or any immediate
family relation of any such Person (collectively, “Interested Persons”), is a
Public Official or Entity. Such Party shall notify the other Party immediately
if during the Term (i) any Interested Person becomes a Public Official or Entity
or (ii) any Public Official or Entity acquires a legal or beneficial interest in
it or its Affiliate or, to its knowledge, in its Sub-distributors or other
subcontractors. 
10.2 Representations, Warranties and Covenants of Distributor. Distributor
represents, warrants, and covenants to Zogenix that:
(a) in the performance of its obligations hereunder, Distributor shall comply
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and shall cause its and its Affiliates’ and Sub-distributors’ employees and
contractors to comply with Applicable Law and Distributor’s compliance policies,
complete copies of which will be provided to Zogenix before the launch of the
Product in the Territory;
(b) during the Term, Distributor agrees that:
(i) Zogenix will have the right, upon reasonable prior written notice and during
Distributor’s regular business hours, to audit Distributor’s and its Affiliates’
books and records by an independent certified public accounting firm of
recognized international standing, and Distributor shall ensure that Zogenix has
the right to audit its Sub-distributors’ and subcontractors’ books and records,
to investigation potential violations of any of the representations, warranties
or covenants in this Section 10.2, the FCPA or other Applicable Laws or
Distributor’s compliance policies. Such audit may be made no more than once each
Fiscal Year (unless an audit reveals a violation under this Agreement, in which
case an additional audit may be conducted within such Fiscal Year);
(ii) Distributor will certify to Zogenix annually in writing or otherwise upon
Zogenix’s written request, under the form set forth in Exhibit 10.2(b) attached
hereto, Distributor’s compliance with the representations, warranties and
covenants in this Section 10.2, the FCPA and other Applicable Laws and
Distributor’s compliance policies;
(iii) Distributor will inform Zogenix promptly of any changes in its business
that would change any of its representations, warranties or covenants in this
Section 10.2;
(iv) Zogenix shall have the right to suspend or terminate the supply of Product
under the Supply Agreement and to terminate this Agreement if there is credible
evidence that Distributor or its Affiliate or Sub-distributor may have violated
any of the representations, warranties or covenants in this Section 10.2 the
FCPA or other Applicable Laws or Distributor’s compliance policies.
10.3 Representations and Warranties of Zogenix. Zogenix represents, warrants and
covenants to Distributor that:
(a) Zogenix will inform Distributor promptly of any changes in its business that
would change any of its representations, warranties or covenants in this
Section 10.3; and
(b) as of the Effective Date, Zogenix has not received written notice of any
pending or threatened claims or actions alleging that the Development or
Commercialization of the Product in the Field infringes or would infringe the
Patents of any Third Party in the Territory.
10.4 Disclaimer. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT AND THE SUPPLY
AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF
ANY KIND, EITHER EXPRESS OR IMPLIED, AND
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EACH PARTY EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE OR USE, NON-INFRINGEMENT, VALIDITY AND
ENFORCEABILITY OF PATENTS, OR THE PROSPECTS OR LIKELIHOOD OF DEVELOPMENT OR
COMMERCIAL SUCCESS OF THE PRODUCT.
10.5 Limitation of Liability. NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM
THE OTHER PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES IN
CONNECTION WITH THIS AGREEMENT; provided however, that this Section 10.5 shall
not be construed to limit (a) either Party’s right to special, incidental or
consequential damages for the other Party’s breach of Article 8 or (b) either
Party’s indemnification rights or obligations under Article 11.

ARTICLE 11.
INDEMNIFICATION
11.1 Indemnification of Zogenix. Distributor shall indemnify, defend and hold
harmless Zogenix and its Affiliates and their respective directors, officers,
employees and agents (the “Zogenix Indemnitees”), from and against any and all
losses, liabilities, damages, penalties, fines, costs and expenses (including
reasonable attorneys’ fees and other expenses of litigation) (“Losses”) incurred
by any Zogenix Indemnitee resulting from any claims, actions, suits or
proceedings brought by a Third Party (“Third Party Claims”) to the extent
arising from, or occurring as a result of: (a) the registration, use, handling,
storage, import, offer for sale, sale or other disposition of the Product in the
Territory by or on behalf of Distributor or its Affiliates; (b) the negligence
or willful misconduct of any Distributor Indemnitees in connection with
Distributor’s performance of its obligations or exercise of its rights under
this Agreement; or (c) any breach of any representations, warranties or
covenants of Distributor in this Agreement, except to the extent such Third
Party Claims fall within the scope of the indemnification obligations of Zogenix
set forth in Section 11.2 or arise out of the breach by Zogenix of any of the
terms of the Supply Agreement.
11.2 Indemnification of Distributor. Zogenix shall indemnify, defend and hold
harmless Distributor and its Affiliates and their respective directors,
officers, employees and agents (the “Distributor Indemnitees”), from and against
any and all Losses incurred by any Distributor Indemnitee resulting from any
Third Party Claims to the extent arising from, or occurring as a result of:
(a) the manufacture, use, handling, storage, import, offer for sale, sale or
other disposition of the Product outside the Territory by or on behalf of
Zogenix or its Affiliates; (b) the negligence or willful misconduct of any
Zogenix Indemnitees in connection with Zogenix’s performance of its obligations
or exercise of its rights under this Agreement; or (c) any breach of any
representations, warranties or covenants of Zogenix in this Agreement, except to
the extent such Third Party Claims fall within the scope of the indemnification
obligations of Distributor set forth in Section 11.1 or arise out of the breach
by Distributor of any of the terms of the Supply Agreement.

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11.3 Procedure. A Party that intends to claim indemnification under this Article
11 (the “Indemnitee”) shall promptly notify the indemnifying Party (the
“Indemnitor”) in writing of any Third Party Claim, in respect of which the
Indemnitee intends to claim such indemnification, and the Indemnitor shall have
sole control of the defense and/or settlement thereof. The Indemnitee may
participate at its expense in the Indemnitor’s defense of and settlement
negotiations for any Third Party Claim with counsel of the Indemnitee’s own
selection. The indemnity arrangement in this Article 11 shall not apply to
amounts paid in settlement of any action with respect to a Third Party Claim, if
such settlement is effected without the consent of the Indemnitor, which consent
shall not be withheld or delayed unreasonably. The failure to deliver written
notice to the Indemnitor within a reasonable time after the commencement of any
action with respect to a Third Party Claim shall only relieve the Indemnitor of
its indemnification obligations under this Article 11 if and to the extent the
Indemnitor is actually prejudiced thereby. The Indemnitee shall cooperate fully
with the Indemnitor and its legal representatives in the investigation of any
action with respect to a Third Party Claim covered by this indemnification.
11.4 Insurance.  Each Party, at its own expense, shall maintain product
liability and other appropriate insurance (or self-insure) in an amount
consistent with industry standards during the Term. Each Party shall provide a
certificate of insurance (or evidence of self-insurance) evidencing such
coverage to the other Party upon written request.

ARTICLE 12.
TERM AND TERMINATION
12.1 Term. This Agreement shall commence on the Effective Date and shall remain
in effect until September 1, 2045, unless earlier terminated by either Party
pursuant to this Article 12 (the “Term”).
12.2 Termination.
(a) Mutual Agreement. The Parties may terminate this Agreement by mutual written
agreement.
(b) Distributor Convenience. At any time following the expiration of the
Distribution Term (as defined in Section 1.17), the Distributor may terminate
this Agreement at will upon [***] prior written notice to Zogenix.
(c) Zogenix Convenience. At any time following the expiration of the
Distribution Term, Zogenix may terminate this Agreement at will upon [***] prior
written notice to Distributor.
(d) Material Breach. If either Party believes in good faith that the other is in
material breach of its obligations hereunder, then the non-breaching Party may
deliver written
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notice of such breach to the other Party, and the allegedly breaching Party
shall have [***] from receipt of such notice to dispute the validity of such
breach. For all breaches of this Agreement, the allegedly breaching Party shall
have [***] from the receipt of the initial notice to cure such breach. If the
Party receiving notice of breach fails to cure the breach within such [***]
period, then the non-breaching Party may terminate this Agreement in its
entirety effective on written notice of termination to the other Party.
Notwithstanding the foregoing, (a) if such material breach (other than a payment
breach), by its nature, is curable, but is not reasonably curable within the
[***] period, then such period shall be extended if the breaching Party provides
a written plan for curing such breach to the non-breaching Party and uses
Commercially Reasonable Efforts to cure such breach in accordance with such
written plan; provided, that no such extension shall exceed [***] without the
consent of the non-breaching Party.
(e) Diligence. Zogenix shall have the right to terminate this Agreement pursuant
to Section 5.1(d).
(f) Bankruptcy. A Party shall have the right to terminate this Agreement upon
written notice to the other Party upon the bankruptcy, dissolution or winding up
of such other Party, or the making or seeking to make or arrange an assignment
for the benefit of creditors of such other Party, or the initiation of
proceedings in voluntary or involuntary bankruptcy, or the appointment of a
receiver or trustee of such other Party’s property, that is not discharged
within [***].
(g) Commercial Viability. In the event that prior to launch of the Product in
the Field in the Territory (i) either Party has a good faith concern that the
launch of the Product in the Field in the Territory is not likely to be possible
with Commercially Reasonable Efforts, based upon credible evidence, such as any
decision by a Regulatory Authority to require significant additional information
before granting or as a condition to granting Regulatory Approval, or
(ii) Distributor has a good faith concern that the Commercialization of the
Product in the Territory will not be commercially viable, such Party may raise
such concern for discussion by the JSC. If, within the time periods set forth in
Section 3.1(d) or such longer time period as the Parties may mutually agree upon
in writing, neither the JSC nor the Executives agree whether to launch or
commercialize Product in the Territory, then, notwithstanding anything to the
contrary in Section 3.1(d) or Article 13, either Party shall have the right to
terminate this Agreement upon at least [***] written notice to the other Party.
(h) Third Party Patent.
(i) Distributor shall have the right to terminate this Agreement upon written
notice to Zogenix if (A) the Parties have discussed an issued Patent under
Section 9.4(a), (B) either (1) both Zogenix and Distributor agree not to seek a
license under such issued Patent or (2) the applicable Party as determined
pursuant to Section 9.4(a) failed to obtain a license under such issued Patent,
after good faith efforts to do so, within [***] after the Parties’ agreement as
to which Party would seek such license, and (C) Distributor reasonably and in
good faith believes that the sale, offer for sale or import of the Product in
the Territory in the Field infringes such issued Patent in the Territory, such
that Distributor is not able to sell the Product in
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the Territory in the Field without infringing such issued Patent.
(ii) Zogenix shall have the right to terminate this Agreement upon written
notice to Distributor if (A) the Parties have discussed an issued Patent under
Section 9.4(a), (B) either (1) both Zogenix and Distributor agree not to seek a
license under such issued Patent or (2) the applicable Party as determined
pursuant to Section 9.4(a) failed to obtain a license under such issued Patent,
after good faith efforts to do so, within [***] after the Parties’ agreement as
to which Party would seek such license, and (C) Zogenix reasonably and in good
faith believes that the manufacture for and sale to Distributor of the Product
infringes such issued Patent, such that Zogenix will not be able to conduct (or
have conducted on its behalf) such manufacturing for and sale of the Product to
Distributor without infringing (or its contract manufacturers infringing) such
issued Patent.
(i) Change of Control. This Agreement may be terminated by either Party upon
[***] written notice to the other Party in the event that the other Party
undergoes a Change of Control; provided, however, that such termination notice
shall only be effective if delivered within [***] after the later of the
occurrence of such Change of Control or the date the Party undergoing the Change
of Control delivers written notice thereof to the other Party.
(j) Other Zogenix Termination Rights. Zogenix shall have the right to terminate
this Agreement immediately upon written notice to Distributor (i) if Distributor
or any of its Affiliates or Sub-distributors, directly or indirectly through any
Third Party, commences any interference or opposition proceeding with respect
to, challenges the validity or enforceability of, or opposes any extension of or
the grant of a supplementary protection certificate with respect to, any Zogenix
Patent (or any related Patent owned or controlled by Zogenix outside the
Territory); (ii) if Zogenix determines that Distributor or its Affiliates or
Sub-distributors are, or have caused or shall cause any Zogenix Indemnitee to
be, in violation of the FCPA or any other Applicable Laws; or (iii) if Zogenix
decides to withdraw the Product from the market in the Territory or otherwise
believes that the promotion of the Product in the Field in the Territory
presents a substantial risk of harm or injury to consumers which risk is
unacceptable according to established principles of medical ethics.
(k) Termination of Supply Agreement. Following the execution of the Supply
Agreement pursuant to Section 5.2, the Parties agree that this Agreement shall
automatically terminate upon termination of the Supply Agreement for any reason.
(l) Distributor Safety Concern. This Agreement may be terminated by Distributor
upon written notice to Zogenix, in the event that Distributor has a reasonable
belief after due inquiry that the promotion of the Product in the Field in the
Territory presents a substantial risk of harm or injury to consumers which risk
is unacceptable according to established principles of medical ethics. Prior to
terminating this Agreement in accordance with this Section 12.2(l), Distributor
shall present evidence supporting the basis for such termination to Zogenix and
shall consider in good faith all comments provided by Zogenix prior to
terminating this Agreement.

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12.3 Rights on Termination. The following will apply upon any termination of
this Agreement:
(a) Termination of Rights and Obligations. Upon termination of this Agreement,
all rights and obligations of the Parties under this Agreement will terminate,
except as provided in this Section 12.3 and Sections 12.4, 12.5 and 12.6. Within
[***] after the effective date of termination of this Agreement, each Party
shall deliver to the other Party any and all Confidential Information of such
other Party then in its possession, except to the extent a Party retains the
right to use such Confidential Information pursuant to any rights granted under
this Agreement that survive termination of this Agreement, and except for one
(1) copy which may be kept in such Party’s (or its counsel’s) office for
archival purposes subject to a continuing obligation of confidentiality and
non-use under Article 8 for the duration set forth in Section 8.1. Neither Party
shall be required to destroy Confidential Information contained in any
electronic back-up tapes or other electronic back-up files that have been
created solely by its automatic or routine archiving and back-up procedures, to
the extent created and retained in a manner consistent with its standard
archiving and back-up.
(b) Technology and Trademark License, Including Right to Reference and
Technology Transfer. In the event that Zogenix terminates this Agreement
pursuant to Section 12.2(c) or Distributor terminates this Agreement pursuant to
Section 12.2(d), or after the expiration of this Agreement in accordance with
Section 12.1, Zogenix shall negotiate in good faith with Distributor a license
agreement for Distributor to make, use and sell the Product in the Field in the
Territory under the Zogenix Technology, Zogenix Trademarks and the Product
Trademarks. Any such license would include a royalty rate for the net sales of
Product in the Field in the Territory of [***] if this Agreement is terminated
by Distributor pursuant to Section 12.2(d) or of [***] if this Agreement is
terminated by Zogenix pursuant to Section 12.2(c) or if the Agreement expires in
accordance with Section 12.1. For clarity, the royalty rates, as applicable, set
forth in this Section would be the total royalty due to Zogenix on Net Sales of
the Product in the Territory under any such license agreement. In the event that
Zogenix is the holder of the Regulatory Approval for the Product in the
Territory at the time of termination pursuant to Section 12.2(c) by Zogenix or
Section 12.2(d) by Distributor or expiration pursuant to Section 12.1, such
license agreement shall also include a grant by Zogenix to Distributor of the
right to reference and use all Data and Regulatory Filings (including all
Regulatory Approvals), such reference and use solely for maintaining Regulatory
Approval and commercializing the Product in the Territory in the Field. Such
license shall also include Zogenix’s agreement to use Commercially Reasonable
Efforts to enable Distributor to establish manufacturing capability for the
Product in or for the Territory at Distributor’s cost. Such support and
assistance would include: (i) amending agreements with Zogenix’s contract
manufacturers of Product for the Territory to permit such contract manufacturers
to enter into manufacturing agreements with Distributor to manufacture the
Product in or for the Territory and introducing Distributor to such contract
manufacturers, (ii) provision of reasonable access to and consultation with
Persons knowledgeable of the manufacture of such Products and (iii) providing
such technical assistance as may be reasonably requested by Distributor relating
to methods and manufacturing know-how transfer to Distributor’s manufacturing
facility. Such license
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agreement would include such other standard terms and conditions for license
agreements of this type as are mutually agreed to by the Parties.
(c) Commercialization Transition. Unless this Agreement is terminated by Zogenix
under Sections 12.2(f), (g)(i), (h)(ii), (j)(ii), or (j)(iii), or by Distributor
under Sections 12.2(d), (g), or (l), or terminated automatically under Section
12.2(k), Distributor shall continue, to the extent that Distributor continues to
have Product inventory, to fulfill orders received from customers for Product in
the Territory until up to [***] after the date on which Zogenix notifies
Distributor in writing that Zogenix has secured an alternative distributor for
the Product in the Territory, but in no event for more for than [***] after the
effective date of termination. All Product sold by or on behalf of Distributor
or its Affiliates or Sub-distributors after the effective date of termination
will be included in calculations under Article 6. Notwithstanding the foregoing,
Distributor shall cease such activities upon [***] written notice from Zogenix
at any time after the effective date of termination requesting that such
activities cease. Within [***] after receipt of such cessation request,
Distributor shall provide Zogenix an estimate of the quantity and shelf life of
all Product remaining in Distributor’s or its Affiliates’ or Sub-distributors’
inventory, and Zogenix shall have the right to purchase any such quantities of
Product from Distributor at a price mutually agreed by the Parties.
(d) Assignment of Regulatory Filings and Regulatory Approvals. Unless this
Agreement is terminated by Zogenix under Section 12.2(c), at Zogenix’s option,
which shall be exercised by written notice to Distributor, to the extent
permitted under Applicable Laws, Distributor shall assign or cause to be
assigned to Zogenix or its designee (or to the extent not so assignable,
Distributor shall take all reasonable actions to make available to Zogenix or
its designee the benefits of), at Zogenix’s cost, all Regulatory Filings and
Regulatory Approvals for the Product in the Field in the Territory.
(e) Transition. Unless this Agreement is terminated by Zogenix under Section
12.2(c), Distributor shall use Commercially Reasonable Efforts to cooperate with
Zogenix and/or its designee to effect a smooth and orderly transition in the
registration and Commercialization of the Product in the Field in the Territory
during the applicable notice period under Section 12.2 and following the
effective date of termination. Without limiting the foregoing, Distributor shall
use Commercially Reasonable Efforts to conduct, in an expeditious manner, any
activities to be conducted under this Section 12.3.
(f) Third Party Agreements. Unless this Agreement is terminated by Zogenix under
Section 12.2(c), at the written request of Zogenix, Distributor shall assign to
Zogenix any Product-specific Third Party agreements, to the furthest extent
possible, provided that such assignment is permitted under the Product-specific
agreement or is otherwise agreed by the applicable Third Party. In the event
such assignment is not requested by Zogenix or is not permitted or agreed by
such Third Party, then the rights of such Third Party with respect to the
Product will terminate upon termination of Distributor’s rights. Distributor
shall ensure that each such Third Party (if its contract is not assigned to
Zogenix pursuant to this Section 12.3) will transition any remaining Product
back to Zogenix in the manner set forth in this Section 12.3 as
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if such Third Party were named herein. Distributor shall include provisions
requiring compliance with these provisions in all applicable agreements with
Third Parties.
12.4 Exercise of Right to Terminate. The use by either Party hereto of a
termination right provided for under this Agreement shall not give rise, on its
own, to the payment of damages or any other form of compensation or relief to
the other Party with respect thereto.
12.5 Damages; Relief. Subject to Section 12.4 above, termination of this
Agreement shall not preclude either Party from claiming any other damages,
compensation or relief that it may be entitled to upon such termination.
12.6 Accrued Obligations; Survival. The expiration or termination of this
Agreement for any reason shall not release either Party from any liability that,
at the time of such expiration or termination, has already accrued to such Party
or that is attributable to a period prior to such termination, nor will any
termination of this Agreement preclude either Party from pursuing all rights and
remedies it may have under this Agreement, at law or in equity, with respect to
breach of this Agreement. The following Articles and Sections will survive any
expiration or termination of this Agreement: Sections 4.2(e) (Ownership of
Regulatory Information), 4.9 (Recalls) (to the extent Product remains on the
market that was distributed under this Agreement), 7.4 (Records), 9.1 (Ownership
of Intellectual Property), 9.7 (Zogenix Trademarks) (to the extent applicable to
any post-termination distribution provided under Section 12.3(c)), 9.8 (Product
Trademarks) (to the extent applicable to any post-termination distribution
provided under Section 12.3(c)), 10.5 (Limitation of Liability), 12.3 (Rights on
Termination), 12.4 (Exercise of Right to Terminate), 12.5 (Damages; Relief) and
12.6 (Accrued Obligations; Survival) and Articles 1 (Definitions) (to the extent
necessary to give effect to other surviving provisions), 7 (Payments, Books and
Records) (only with respect to periods prior to termination and, if applicable,
any post-termination distribution provided under Section 12.3(c)), 8
(Confidentiality), 11 (Indemnification), 13 (Dispute Resolution) and 14 (General
Provisions).

ARTICLE 13.
DISPUTE RESOLUTION
13.1 Objective. The Parties recognize that disputes as to matters arising under
or relating to this Agreement or either Party’s rights or obligations hereunder
may arise from time to time. It is the objective of the Parties to establish
procedures to facilitate the resolution of such disputes in an expedient manner
by mutual cooperation and without resort to litigation. To accomplish this
objective, the Parties agree to follow the procedures set forth in this Article
13 to resolve any such dispute if and when it arises.
13.2 Resolution by Executives. Except as otherwise provided in Article 3, if an
unresolved dispute as to matters arising under or relating to this Agreement or
either Party’s rights or obligations hereunder arises, either Party may refer
such dispute to the Executives, who shall meet in person or by telephone within
[***] after such referral to attempt in good faith to
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resolve such dispute. If such matter cannot be resolved by discussion of such
officers within such [***] (as may be extended by mutual written agreement),
such dispute shall be resolved in accordance with Section 13.3. The Parties
acknowledge that discussions between the Parties to resolve disputes are
settlement discussions under applicable rules of evidence and without prejudice
to either Party’s legal position.
13.3 Arbitration.
(a) Any and all disputes that are not resolved pursuant to Section 13.2 shall be
finally settled by binding arbitration administered under the Rules of
Arbitration of the International Chamber of Commerce by three (3) arbitrators
appointed in accordance with said Rules. The arbitration will be conducted in
New York, New York. The language to be used in the arbitral proceedings will be
English. Judgment on the award may be entered in any court having jurisdiction.
(b) The award shall be rendered within [***] of the constitution of the arbitral
tribunal, unless the arbitral tribunal determines that the interest of justice
requires that such limit be extended.
(c) The arbitrators shall award to the prevailing party, if any, as determined
by the arbitrators, its reasonable attorneys’ fees and costs.
(d) The arbitration proceeding will be confidential and the arbitrators shall
issue appropriate protective orders to safeguard each Party’s Confidential
Information. Except as required by Applicable Laws, no Party shall make (or
instruct the arbitrators to make) any public announcement with respect to the
proceedings or decision of the arbitrators without prior written consent of the
other Party. The existence of any dispute submitted to arbitration, and the
award, shall be kept in confidence by the Parties and the arbitrators, except as
required in connection with the enforcement of such award or as otherwise
required by Applicable Laws.

ARTICLE 14.
GENERAL PROVISIONS
14.1 Governing Law. This Agreement and all questions regarding its existence,
validity, interpretation, breach or performance and any dispute or claim arising
out of or in connection with it (whether contractual or non-contractual in
nature such as claims in tort, from breach of statute or regulation or
otherwise) shall be governed by, and construed and enforced in accordance with,
the laws of the State of New York, United States, without reference to its
conflicts of law principles to the extent those principles would require
applying another jurisdiction’s laws. The United Nations Conventions on
Contracts for the International Sale of Goods shall not be applicable to this
Agreement or the Supply Agreement.
14.2 Force Majeure. Neither Party shall be held liable to the other Party nor be
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deemed to have defaulted under or breached this Agreement for failure or delay
in performing any obligation under this Agreement (other than failure to make
payment when due) when such failure or delay is caused by or results from causes
beyond the reasonable control of the affected Party, including embargoes, war,
acts of war (whether war be declared or not), insurrections, riots, fire,
floods, or other acts of God, or acts, omissions or delays in acting by any
governmental authority or the other Party. The affected Party shall notify the
other Party of such force majeure circumstances as soon as reasonably
practicable, and shall promptly undertake all reasonable efforts necessary to
cure such force majeure circumstances. Such excuse from liability shall be
effective only to the extent and duration of the event(s) causing the failure or
delay in performance and provided that the Party has not caused such event(s) to
occur.
14.3 Assignment. Except as expressly provided in this Section 14.3, neither this
Agreement nor any rights or obligations hereunder may be assigned or otherwise
transferred by either Party without the prior written consent of the other
Party, which consent shall not be unreasonably withheld; provided, however, that
either Party may assign this Agreement and its rights and obligations hereunder
without the other Party’s consent:
(a) in connection with the transfer or sale of all or substantially all of the
business of the assigning Party to a Third Party, whether by merger, sale of
stock, sale of assets or otherwise; provided that in the event of a transaction
(whether this Agreement is actually assigned or is assumed by the acquiring
party by operation of law (e.g., in the context of a reverse triangular
merger)), unless otherwise agreed with the acquiring party in writing,
intellectual property of the acquiring party shall not be included in the
intellectual property to which the other Party has access under this Agreement;
or
(b) to an Affiliate, provided that the assigning Party shall remain liable and
responsible to the non‑assigning Party hereto for the performance and observance
of all such duties and obligations by such Affiliate.
For the avoidance of doubt, in the event that either Party assigns this
Agreement pursuant to this Section 14.3(a), the other Party shall have the right
to terminate this Agreement pursuant to Section 12.2(i). This Agreement shall be
binding upon successors and permitted assigns of the Parties. Any assignment not
in accordance with this Section 14.3 will be null and void.
14.4 Severability. If any one or more of the provisions contained in this
Agreement is held invalid, illegal or unenforceable in any respect, the
validity, legality and enforceability of the remaining provisions contained
herein shall not in any way be affected or impaired thereby, unless the absence
of the invalidated provision(s) adversely affects the substantive rights of the
Parties. The Parties shall in such an instance use their best efforts to replace
the invalid, illegal or unenforceable provision(s) with valid, legal and
enforceable provision(s) which, insofar as practical, implement the purposes of
this Agreement.
14.5 Notices. All notices required or permitted hereunder shall be in writing
and sufficient if delivered personally, sent by facsimile (and promptly
confirmed by personal delivery, registered or certified mail or overnight
courier), sent by internationally-recognized
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overnight courier or sent by registered or certified mail, postage prepaid,
return receipt requested, addressed as follows:
If to Zogenix, addressed to:
Zogenix, Inc.
5959 Horton Street, Suite 500
Emeryville, CA 94608, U.S.A
Attention: Chief Executive Officer
Facsimile Number: +1 (510) 550-8340
With a copy to (which shall not constitute notice):
Latham & Watkins, LLP
12670 High Bluff Drive
San Diego, CA 92130, U.S.A
Attention: Cheston Larson, Esq.
Facsimile Number: +1 (858) 523-5450
If to Distributor, addressed to:
Nippon Shinyaku Co., Ltd.
14, Nishinosho-monguchi-cho
Kisshoin, Minami-ku
Kyoto 601-8550, JAPAN
Attention: Alliance Department
Facsimile Number: +81-75-321-9019
or to such other address as the Party to whom notice is to be given may have
furnished to the other Party in writing in accordance herewith. Any such notice
shall be deemed to have been given: (a) when delivered if personally delivered
or sent by facsimile on a Business Day; and (b) on the second Business Day after
dispatch if sent by internationally-recognized overnight courier.
14.6 Entire Agreement; Amendments. This Agreement and the Supply Agreement,
together with the exhibits hereto and thereto, contain the entire understanding
of the Parties with respect to the subject matter hereof and thereof and
supersede and cancel all previous express or implied agreements and
understandings, negotiations, writings and commitments, either oral or written,
in respect to the subject matter hereof and thereof, including the
Confidentiality Agreement. This Agreement may be amended, or any term hereof
modified, only by a written instrument duly executed by authorized
representatives of both Parties, but “written instrument” does not include the
text of e-mails or similar electronic transmissions.
14.7 Headings. The captions to the several Articles and Sections hereof are not
a part of this Agreement, but are merely for convenience to assist in locating
and reading the several
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Sections hereof.
14.8 Independent Contractors. It is expressly agreed that Zogenix and
Distributor shall be independent contractors and that the relationship between
the two Parties shall not constitute a partnership, joint venture or agency.
Neither Zogenix nor Distributor shall have the authority to make any statements,
representations or commitments of any kind or to take any action that shall be
binding on the other Party, without the prior written consent of the other
Party.
14.9 Waiver. The waiver by either Party hereto of any right hereunder, or the
failure of the other Party to perform, or a breach by the other Party, shall not
be deemed a waiver of any other right hereunder or of any other breach or
failure by such other Party whether of a similar nature or otherwise.
14.10 Cumulative Remedies. No remedy referred to in this Agreement is intended
to be exclusive, but each shall be cumulative and in addition to any other
remedy referred to in this Agreement or otherwise available under law.
14.11 Waiver 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 shall be construed against the drafting Party shall not apply.
14.12 Interpretation. All references in this Agreement to an Article or Section
shall refer to an Article or Section in or to this Agreement, unless otherwise
stated. Any reference to any federal, national, state, local, or foreign statute
or law shall be deemed also to refer to all rules and regulations promulgated
thereunder, unless the context requires otherwise. The word “including” and
similar words means including without limitation. The words “herein,” “hereof”
and “hereunder” and other words of similar import refer to this Agreement as a
whole and not to any particular Section or other subdivision. All references to
days, months, quarters or years are references to calendar days, calendar
months, calendar quarters, or calendar years, unless stated otherwise.
References to the singular include the plural.
14.13 No Third Party Beneficiaries. This Agreement is neither expressly nor
impliedly made for the benefit of any Party other than Zogenix and Distributor,
except as otherwise provided in this Agreement with respect to Zogenix
Indemnitees under Section 11.1 and Distributor Indemnitees under Section 11.2.
This Agreement may be terminated, varied or amended in accordance with its terms
or with the agreement of Distributor and Zogenix without the consent of the
Zogenix Indemnitees or Distributor Indemnitees.
14.14 English Language. This Agreement is in the English language, and the
English language shall control its interpretation. In addition, unless otherwise
explicitly stipulated in this Agreement, all notices required or permitted to be
given under this Agreement, and all written, electronic, oral or other
communications between the Parties regarding this Agreement, shall be in the
English language.

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14.15 Counterparts. This Agreement may be executed in two counterparts, each of
which shall be deemed to be an original as against any party whose signature
appears thereon, all of which together shall constitute but one and the same
instrument.
14.16 Further Actions. Each Party will execute, acknowledge and deliver such
further instruments, and to do all such other ministerial, administrative or
similar acts, as may be necessary or appropriate in order to carry out the
purposes and intent of this Agreement.
[Signature Page Follows]

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IN WITNESS WHEREOF, the Parties have executed this Distributorship Agreement as
of the Effective Date.

ZOGENIX, INC.
NIPPON SHINYAKU COMPANY, LTD.
By:/s/ Stephen J. FarrBy:/s/Shigenobu MaekawaName:Stephen J. FarrName:Shigenobu
MaekawaTitle:President and Chief Executive OfficerTitle:President

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Exhibit 1.70
UNLABELED DRUG PRODUCT

[***][***] [***] [***] [***] [***] [***] 

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Exhibit 1.74
ZOGENIX ZX008 PATENTS AS OF THE EFFECTIVE DATE

Patents claiming ZX008 or its use in Japan
Docket No
Appln. No
Filing Date
Publn. No
Patent No
Issue Date[***]ZGNX-135JP[***][***][***][***]11/30/18ZGNX-135JP DIV[***][***]

[***]
ZGNX-143JP[***][***][***]

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Exhibit 2.3
MATERIAL TERMS OF SUPPLY AGREEMENT
The Supply Agreement will include the following terms and conditions:
1. Appointment as Exclusive Supplier. During the Term, Zogenix shall retain and
have the sole and exclusive right to supply or have supplied all of
Distributors’ and its Affiliates’ and Sub-distributors’ requirements of the
Product for sale in the Field in the Territory.
2. Transfer Price. The price at which Zogenix supplies the Product (as Unlabeled
Drug Product) to Distributor equals the consideration and Transfer Price set
forth in the Agreement in Section 6.5. Distributor shall make payment in
accordance with Sections 6.1, 6.3, and 6.4, and shall also pay Zogenix’s invoice
for the estimated Transfer Price within [***] of the date on which the
applicable units of Product are delivered by Zogenix in accordance Section 6.5
and the terms of the Supply Agreement. The Parties will true-up the
Fully-Burdened Manufacturing Cost on an annual basis when truing-up the Transfer
Price. For any Product that is supplied to Distributor under this Agreement and
damaged by Distributor during labeling or packaging, the transfer price for any
such Product shall be [***] per unit of Product for the applicable Fiscal Year.
The Supply Agreement shall also include terms permitting Distributor to audit
Zogenix’s Fully-Burdened Manufacturing Costs that are similar to Zogenix’s audit
rights in Section 7.5 of the Agreement.
3. Third Party Manufacturer Agreements. The terms of the Supply Agreement shall
(a) establish the procedures, terms and conditions for manufacture, quality
control, forecasting, ordering, delivery price, payment and appropriate other
activities relating to the supply of the Product in the Territory so as to
reasonably enable Zogenix to meet its obligations under its agreements with
Third Party manufacturers and (b) provide Distributor no remedies for Zogenix’s
failure to supply the Product in accordance with the Supply Agreement that are
in addition to those set forth herein or that are available to Zogenix in its
existing agreements with Third Party manufacturers, and (c) set forth such terms
and conditions so that the Supply Agreement is otherwise consistent in all
material respects with such agreements with Third Party manufacturers.
4. Forecasts and Orders. [***] prior to the anticipated First Commercial Sale,
Distributor shall provide Zogenix with a good faith, [***] rolling forecast of
its anticipated requirements of the Product, the first [***] of which shall be
on a monthly basis and the last [***] of which shall be on a quarterly basis.
The first [***] of such forecast shall be binding. Distributor shall submit
binding purchase orders consistent with the binding portion of its forecasts.
Each purchase order shall have a requested delivery date that is at least [***]
after the date of the purchase order. The terms of the Supply Agreement shall
also provide for the order and delivery of launch stock for the Product prior to
Regulatory Approval to ensure timely launch of the product following Regulatory
Approval.

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Purchase orders shall be placed in full batch increments as defined in the
Supply Agreement.
5. Delivery. All Products shall be shipped Ex Works manufacturing site
(Incoterms 2010) to the destination requested by Distributor. Distributor shall
be responsible for labeling and packaging Product.
6. Safety Stock. Distributor shall use Commercially Reasonable Efforts to build
promptly following Regulatory Approval and thereafter to maintain an inventory
of Product (itself and/or with wholesalers) which is not less than the
equivalent of the immediate next [***] of anticipated demand for the Product in
the Territory.
7. Change Controls. The Parties shall include in the Supply Agreement a
reasonable change control procedure to deal with any reasonable changes to the
Product specifications and other changes required by Applicable Laws. All Third
Party costs incurred by either Party for any such changes in accordance with the
agreed-upon change control procedure shall be paid by Distributor if requested
by Distributor or if such changes are required by Applicable Laws in the
Territory.
8. Second Source. Based on Distributor’s forecasts, including its [***]
forecasts, the Parties will discuss and determine whether Zogenix will obtain
additional capacity to support Distributor’s requirements for the Product in the
Territory. Any decisions to build or engage additional manufacturing capacity
for the Territory will be at Zogenix’s sole discretion, and in no event will
Zogenix be obligated to supply Product in excess of Distributor’s binding
forecasts.
9.  Product Quality/Complaints. The Supply Agreement will define procedures for
resolution of any disputes regarding Product quality and for notification of
each Party in the event of a Product complaint or Product recall. The Supply
Agreement will contain mutually acceptable provisions regarding release testing
of the Product and, if applicable, the transfer of information necessary for
Distributor to perform required quality testing, as applicable.
10. Regulatory Audits. Not more than once per Fiscal Year or as otherwise agreed
by the Parties, and subject to the terms of the applicable agreement between
Zogenix and its Third Party manufacturers, Zogenix shall, at Distributor’s
request, conduct GMP audits of the Third Party manufacturers and, if applicable,
exercise such other audit rights that Zogenix may have under such agreements,
and shall disclose to Distributor the results of such audits. Zogenix will use
commercially reasonable efforts to cause such Third Party manufacturers to
promptly correct any deficiencies or other adverse findings.
11. Representations and Warranties. Zogenix shall provide standard warranties
applicable in the pharmaceutical industry, including warranties that all Product
manufactured for Distributor:

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a. shall be manufactured and tested in accordance with all Applicable Laws,
including GMP applicable to the manufacturing, storage, and shipment of the
Product,
b. shall not be adulterated or misbranded within the meaning of the United
States Food, Drug and Cosmetic Act, 21 U.S.C. Section 301c et. seq., or other
Applicable Laws, and
c. the time of delivery to Distributor will meet the Product specifications.
12. Quality Agreement. The Parties shall work together in good faith to enter
into a mutually acceptable quality agreement with respect to the manufacture of
the Product prior to shipment of any Product to Distributor.

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Exhibit 4.2(a)
THE INITIAL VERSION OF THE REGULATORY PLAN

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Exhibit 8.5(a)
PRESS RELEASE

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Exhibit 9.7
ZOGENIX TRADEMARKS

TrademarkCountryStatusRegistration
numberNext renewal dateApplication
numberApplication
dateRegistration
dateClass
(Zogenix Logo)
 JapanPendingN/AN/A2019031449 2/28/2019N/A5, 42 

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Exhibit 9.8
PRODUCT TRADEMARKS

TrademarkCountryStatusRegistration
numberNext renewal dateApplication
numberApplication
dateRegistration
dateClassFINTEPLAJapanRegistered 610509912/7/20282018028557 3/9/201812/7/2018 5
(Fintepla Logo)
 Japan Registered6093116 10/26/20282018028558 3/9/201810/26/20185 

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Exhibit 10.2(b)
FORM OF COMPLIANCE CERTIFICATION

Date: __________
To: Zogenix, Inc. and its Affiliates (“Zogenix”)
Re: Distributorship Agreement dated [ ] (“the Agreement”)
For and on behalf of [__________________] and our Affiliates (as defined in the
Agreement) and employees, we confirm that in respect of our distribution of
Zogenix Product within the Territory during the period [insert date] to [insert
date]:-
•there was no offer, or promise to make, authorize or provide (directly or
indirectly) a gift, payment or anything of value to a government official,
political parties or candidates or private sector employee, in order to
influence or reward any action or decision by such person in his or her official
or professional capacity, for the purpose of corruptly obtaining or retaining
business or securing any improper advantage;
•all payments, expenses or credits properly paid to or incurred on behalf of
Zogenix, were accurately and appropriately recorded and described in accordance
with acceptable accounting and recordkeeping procedures, and substantiated by
supporting documents and evidence;
•there were no unauthorized and/or excessive payments of any kind to health care
institutions, hospitals, hospital services or departments; and
•has performed the necessary due diligence to ensure compliance with Applicable
Laws (including anti-bribery laws and the U.S. FCPA) and the terms of the
Agreement.
Please be advised accordingly.
Yours faithfully,

[____________________]
Authorized Representative
Name:    Title:
Signature:   Date:

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