Exhibit 10.1

 

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Double asterisks denote omissions. Execution Version

AMENDED AND RESTATED

COLLABORATION AND LICENSE AGREEMENT

by and between

EISAI CO., LTD.

and

EPIZYME, INC.

CONFIDENTIAL

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Table of Contents

 

               Page  

ARTICLE 1

   DEFINITIONS      2   

ARTICLE 2

   COLLABORATION OVERVIEW; DEVELOPMENT ACTIVITIES      18       2.1   
Collaboration Overview      18       2.2    Development Activities      18      
2.3    Reports; Results      19       2.4    Subcontracting      19       2.5   
Regulatory Matters; Compliance      19       2.6    Transition Matters      20
  

ARTICLE 3

   COMMERCIALIZATION ACTIVITIES; DILIGENCE; MANUFACTURING AND SUPPLY      21   
   3.1    Commercialization      21       3.2    Diligence      21       3.3   
Manufacturing and Supply      22   

ARTICLE 4

   GOVERNANCE      23       4.1    Joint Steering Committee      23       4.2   
Alliance Managers      25       4.3    Senior Management Meetings      25   

ARTICLE 5

   LICENSE GRANTS      25       5.1    License Grant To EISAI      25       5.2
   License Grants to EPIZYME      26       5.3    Rights Retained by the Parties
     27       5.4    Section 365(n) of the Bankruptcy Code      27       5.5   
Access to Know-How      28       5.6    Right of Negotiation      28   

ARTICLE 6

   FINANCIAL TERMS      29       6.1    Reimbursement of Previous Development
Costs      29       6.2    Development Costs      29       6.3    Development
Milestones      29       6.4    Licensed Product Royalties      31       6.5   
Blended Royalty      34       6.6    Reports; Royalty Payments      34       6.7
   Methods of Payments      34       6.8    Accounting      35       6.9   
Withholding Taxes      36       6.10    Late Payments      36       6.11   
Limitations on Payments for [**] Use      36       6.12    FDA Priority Review
Voucher      37   

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Table of Contents

               Page  

ARTICLE 7

   EXCLUSIVITY; CHANGE OF CONTROL      37       7.1    Target Exclusivity     
37       7.2    Exceptions      38   

ARTICLE 8

   INTELLECTUAL PROPERTY RIGHTS      38       8.1    Ownership      38       8.2
   Prosecution and Maintenance of Patents      39       8.3    Patent Costs     
41       8.4    Defense of Claims Brought by Third Parties      41       8.5   
Enforcement of EPIZYME Patents, Collaboration Patents and Joint Patents      41
      8.6    Invalidity or Unenforceability Defenses or Actions      43      
8.7    Third Party Licenses      44       8.8    Ownership and Prosecution of
Product Trademarks      44   

ARTICLE 9

   CONFIDENTIALITY      45       9.1    Confidentiality; Exceptions      45   
   9.2    Product Information      45       9.3    Authorized Disclosure      46
      9.4    Press Release; Disclosure of Agreement      47       9.5   
Termination of Prior Confidentiality Agreement      47       9.6    Remedies   
  48       9.7    Publications      48       9.8    Clinical Trial Register     
49       9.9    Use of Name      49       9.10    Return of Confidential
Information      49   

ARTICLE 10

   REPRESENTATIONS AND WARRANTIES      50       10.1    Representations and
Warranties of Both Parties      50       10.2    Representations and Warranties
of EPIZYME      50       10.3    Representations and Warranties of EISAI      53
      10.4    Mutual Covenants      53       10.5    Disclaimer      53   

ARTICLE 11

   INDEMNIFICATION; INSURANCE      54       11.1    Indemnification by EISAI   
  54       11.2    Indemnification by EPIZYME      54       11.3    Procedure   
  56       11.4    Insurance      56       11.5    LIMITATION OF LIABILITY     
57   

ARTICLE 12

   TERM AND TERMINATION      57       12.1    Term; Expiration      57      
12.2    Unilateral Termination      57       12.3    Termination for Cause     
58       12.4    Termination for EISAI Patent Challenge      59   

 

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Table of Contents

               Page      12.5    Effects of Termination      60       12.6   
Accrued Rights; Surviving Provisions      69   

ARTICLE 13

   MISCELLANEOUS      70       13.1    Dispute Resolution      70       13.2   
Arbitration Request      70       13.3    Governing Law      71       13.4   
Assignment      71       13.5    Performance Warranty      72       13.6   
Force Majeure      72       13.7    Notices      73       13.8    Export Clause
     74       13.9    Waiver      74       13.10    Severability      74      
13.11    Entire Agreement      74       13.12    Independent Contractors      74
      13.13    Non-solicitation of Key Employees      75       13.14   
Headings; Construction; Interpretation      75       13.15    Books and Records
     75       13.16    Further Actions      75       13.17    Parties in
Interest      76       13.18    Performance by Affiliates      76       13.19   
Counterparts      76       13.20    Amendment and Restatement; No Novation     
76   

List of Exhibits

 

Exhibit A    -    EPIZYME Patents (as of the Restatement Date) Exhibit B    -   
Transition Matters Exhibit C    -    Press Release Exhibit D    -    Asia

 

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AMENDED AND RESTATED COLLABORATION AND LICENSE AGREEMENT

This AMENDED AND RESTATED COLLABORATION AND LICENSE AGREEMENT (this “Agreement”)
is entered into and made effective as of the 12th day of March, 2015 (the
“Restatement Date”) by and between Epizyme, Inc., a Delaware corporation having
its principal place of business at 400 Technology Square, 4th Floor, Cambridge,
Massachusetts 02139, U.S.A. (“EPIZYME”), and Eisai Co., Ltd., a Japan
corporation, having its principal place of business at Koishikawa 4-6-10,
Bunkyo-Ku, Tokyo 112-8088, Japan (“EISAI”). EPIZYME and EISAI are each referred
to herein by name or as a “Party” or, collectively, as the “Parties.”

RECITALS

WHEREAS, EPIZYME possesses proprietary technology and intellectual property to
identify and develop novel, small molecule histone methyltransferase (“HMT”)
inhibitors;

WHEREAS, EISAI possesses expertise in the Development and Commercialization
(each as defined below) of human pharmaceuticals;

WHEREAS, EISAI and EPIZYME previously entered into a Collaboration and License
Agreement effective April 1, 2011 (such agreement, as previously amended, the
“Prior Agreement” and such date, the “Prior Agreement Effective Date”) under
which they collaborated with respect to the Development and Commercialization of
EZH2 Compounds (as defined below);

WHEREAS, EISAI and EPIZYME now desire to amend and restate the Prior Agreement
to reflect their agreement to engage in further collaborative efforts pursuant
to which EPIZYME will carry out global Development activities directed to EZH2
(as defined below) and Commercialize resulting Licensed Products (as defined
below) in the EPIZYME Territory (as defined below) and EISAI will carry out
Japan-Specific Development Activities (as defined below) directed to such
Licensed Products and Commercialize such Licensed Products in the EISAI
Territory (as defined below); and

WHEREAS, concurrently with the execution of this Agreement, EISAI and EPIZYME
are separately amending and restating their letter agreement dated December 21,
2012 regarding their Companion Diagnostics Agreement dated December 18, 2012
(the “Existing RMS Agreement”) with Roche Molecular Systems, Inc., as amended
(such amended and restated letter agreement, the “Amended CDx Letter
Agreement”).

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

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ARTICLE 1

DEFINITIONS

As used in this Agreement, the following terms will have the meanings set forth
in this Article 1 unless context dictates otherwise:

1.1 “Affiliate” means, with respect to a Person, any other Person which,
directly or indirectly through one (1) or more intermediaries, controls, is
controlled by or is under common control with such Person, regardless of whether
such Affiliate is or becomes an Affiliate on or after the Prior Agreement
Effective Date. A Person shall be deemed to “control” another Person if it
(a) owns, directly or indirectly, beneficially or legally, more than fifty
percent (50%) of the outstanding voting securities or capital stock of such
other Person, or has other comparable ownership interest with respect to any
Person other than a corporation; or (b) has the power, whether pursuant to
contract, ownership of securities or otherwise, to direct the management and
policies of such other Person.

1.2 “Applicable Commercialization Party” means EISAI with respect to the EISAI
Territory and EPIZYME with respect to the EPIZYME Territory.

1.3 “Asia” means the countries identified on Exhibit E.

1.4 “Bayh-Dole Act” means the Patent and Trademark Law Amendments Act of 1980,
as amended, codified at 35 U.S.C. §§ 200-212, as amended, as well as any
regulations promulgated pursuant thereto, including in 37 C.F.R. § 401.

1.5 “Business Day” means a day on which banking institutions in Boston,
Massachusetts are open for business, excluding any Saturday or Sunday.

1.6 “Calendar Quarter” means a period of three (3) consecutive months ending on
the last day of March, June, September, or December, respectively.

1.7 “Calendar Year” means a period of twelve (12) consecutive months beginning
on January 1 and ending on December 31.

1.8 “cGMP” means all Laws governing Manufacturing practices for intermediates,
bulk products or finished products, including the regulations set forth in the
FDA’s current Good Manufacturing Practices, 21 CFR Parts 210 and 211, and The
Rules Governing Medicinal Products in the European Community, Volume IV, Good
Manufacturing Practice for Medicinal Products, as each may be amended from time
to time.

1.9 “Change of Control Event” means (a) a Party (i) merges or consolidates with
any Third Party, or (ii) effects any other transaction or series of related
transactions involving the transfer of capital stock of such Party to a Third
Party, other than a transaction in which such Party or underwriters for such
Party sell securities of such Party (A) in a public offering, or (B) directly to
bona fide venture capital investors or bona fide institutional investors that
routinely make such investments for the potential financial return on such
investments and not with any view to acquisition, in the case of each of the
foregoing clauses (i) and (ii) such that the stockholders of such Party
immediately prior thereto, in the aggregate, no longer beneficially own more
than fifty percent (50%) of the outstanding voting securities of the surviving
entity or the ultimate parent of the surviving entity, following the closing of
such merger, consolidation, other transaction or series of related transactions;
(b) such Party sells all or substantially all of its business or assets to which
this Agreement relates to a Third Party; or (c) any “person” or “group” (as such
terms are defined under Section 13(d) and 14(d) of the United States Securities
Exchange Act of 1934) obtains control (as defined in Section 1.1) of such Party.

 

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1.10 “Clinical Trial” means a Phase 1 Clinical Trial, Phase 2 Clinical Trial,
Phase 3 Clinical Trial, or a study incorporating more than one of these phases.

1.11 “Collaboration IP” means Collaboration Know-How and Collaboration Patents.

1.12 “Collaboration Know-How” means EISAI Collaboration Know-How and EPIZYME
Collaboration Know-How.

1.13 “Collaboration Patents” means EISAI Collaboration Patents and EPIZYME
Collaboration Patents.

1.14 “Commercialization” and “Commercialize” means all activities undertaken
with respect to a product relating to marketing, promotion (including
advertising and detailing), medical affairs activities, medical science liaison
activities, sponsored product or continuing medical education activities,
post-Regulatory Approval clinical studies (that are not required to obtain or
maintain such Regulatory Approval), obtaining pricing and reimbursement
approval, in each case with respect to such product, any importing, offering for
sale, distribution and sale of such product, identifying, screening or
diagnosing patients as potential users of such product, interacting with
Regulatory Authorities regarding the foregoing, and Manufacturing commercial
supplies for the foregoing activities.

1.15 “Commercially Reasonable Efforts” means:

(a) with respect to EPIZYME, subject to the last paragraph of this Section 1.15,
such efforts that are consistent with the efforts and resources normally used by
EPIZYME in the exercise of its reasonable business discretion relating to the
Development and Commercialization of a potential pharmaceutical product:

(i) that is at a similar stage in its Development or product life as the
relevant Compound, Licensed Compound or Licensed Product; and

(ii) that has commercial and market potential similar to the relevant Compound,
Licensed Compound or Licensed Product, taking into account issues of
intellectual property scope, subject matter and coverage, safety and efficacy,
product profile, competitiveness of the marketplace, proprietary position and
profitability (including pricing and reimbursement status achieved or likely to
be achieved, and royalties and other payments required under this Agreement);
and

(b) with respect to EISAI, such efforts that are consistent with the efforts and
resources normally used by EISAI in the exercise of its reasonable business
discretion relating to the Development and Commercialization of a potential
pharmaceutical product:

(i) that is at a similar stage in its Development or product life as the
relevant Compound, Licensed Compound or Licensed Product; and

 

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(ii) that has commercial and market potential similar to the relevant Compound,
Licensed Compound or Licensed Product, taking into account issues of
intellectual property scope, subject matter and coverage, safety and efficacy,
product profile, competitiveness of the marketplace, proprietary position and
profitability (including pricing and reimbursement status achieved or likely to
be achieved, and royalties required under this Agreement).

“Commercially Reasonable Efforts” shall be determined on a country-by-country
basis, except that the Party may consider the impact of its efforts and
resources expended with respect to any country on any other country. If either
Party grants a sublicense or assigns its rights and obligations under this
Agreement to an Affiliate or Third Party as permitted under this Agreement,
then, with respect to such Sublicensee, assignee or designee, Commercially
Reasonable Efforts shall mean the efforts and resources (as defined above in
this Section 1.15) normally used by the Party granting the sublicense, assigning
its rights and obligations, qualified by the items in clause (a)(i) – (ii),
inclusive, if EPIZYME is the sublicensing, assigning or designating Party, and
qualified by the items in clause (b)(i) – (ii), inclusive, if EISAI is the
sublicensing, assigning or designating Party; provided that if a Change of
Control Event occurs with respect to EPIZYME, and the Person that acquires,
combines with or comes to control EPIZYME or acquires EPIZYME’s assets as a
result of such Change of Control Event (or any of such Person’s then-existing
Affiliates) already has a Competing Program, then from and after such Change of
Control Event Commercially Reasonable Efforts with respect to EPIZYME shall not
be less than the level of efforts and resources normally used by a company in
the global research-based biotechnology and pharmaceutical industries, qualified
by the items in clause (a)(i) – (ii), inclusive.

1.16 “Comparable Third Party Product” means, with respect to a Therapeutic
Product in any country in the EPIZYME Territory, any pharmaceutical product sold
by a Third Party in such country not authorized by or on behalf of EPIZYME, its
Affiliates or Sublicensees, and with respect to a Therapeutic Product in the
EISAI Territory, any pharmaceutical product sold by a Third Party in the EISAI
Territory not authorized by or on behalf of EISAI, its Affiliates or
Sublicensees, in each case that:

(a) contains, as an active pharmaceutical ingredient, the same Compound as the
Licensed Compound contained in the applicable Therapeutic Product; and

(b) is approved by the applicable Regulatory Authority in such country for one
or more of the same Indications as the applicable Therapeutic Product.

1.17 “Comparable Third Party Product Competition” means, with respect to a
Therapeutic Product in any country in the Territory in a given Calendar Quarter,
that, during such Calendar Quarter:

(a) one or more Comparable Third Party Product(s) is commercially available in
such country; and

(b) such Comparable Third Party Product(s) have a market share of [**] percent
([**]%) or more of the aggregate market in such country of such Therapeutic
Product

 

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and the Comparable Third Party Product(s) collectively (based on sales of units
of such Therapeutic Product and such Comparable Third Party Product(s), as
reported by IMS International, or if such data are not available, such other
reliable data source as reasonably determined by EPIZYME and EISAI). As used
herein, a “unit” of a product means the equivalent amount of product used for an
equivalent treatment cycle of such product.

1.18 “Compound(s)” means a small molecule HMT inhibitor.

1.19 “Control”, “Controls” or “Controlled” means, with respect to any
intellectual property right or Know-How, possession of the right (whether
through ownership or license (other than by operation of this Agreement) or
control (as defined in Section 1.1) over an Affiliate with such right) to grant
the licenses or sublicenses under such intellectual property right or Know-How
as provided herein without violating the terms of any agreement or other
arrangement with any Third Party. Notwithstanding the foregoing, intellectual
property rights or Know-How of a Party that is licensed or otherwise acquired
from a Third Party after the Prior Agreement Effective Date and would otherwise
be considered to be under the Control of a Party shall not be deemed to be under
the Control of such Party if the application of such definition in the context
of any license grants or sublicenses under this Agreement would require the
granting Party to make additional payments or royalties to a Third Party in
connection with such license or sublicense grants, unless the other Party agrees
to pay the additional payments or royalties to the Third Party (but subject to
Section 6.4.4(b)).

1.20 “Cost of Goods” means a Party’s (or its Affiliates’) fully allocated costs
of Manufacturing (or acquiring from a Third Party) Licensed Compound or Licensed
Product for Development or Commercialization, without markup, determined in
accordance with GAAP, consistently applied. For purposes of this definition,
“fully allocated costs” means direct and identifiable internal and external
costs and charges consisting of the following:

(a) with respect to Manufacturing activities conducted by such Party (or its
Affiliates), “fully allocated costs” of Manufacturing Licensed Compound or
Licensed Product shall consist of the following costs and charges: (i) costs of
active pharmaceutical ingredients, other raw materials and packaging components,
plus inbound and outbound freight/transportation, duty, quality assurance (i.e.,
testing, documentation and release of drug product), and other direct raw
materials costs, (ii) labor costs directly involved with the Manufacturing of or
acquiring Licensed Compound or Licensed Product, including quality assurance
(i.e., testing, documentation and release of drug product), (iii) manufacturing
plant overhead charges reasonably allocable to the Licensed Compound or Licensed
Product, including indirect labor and indirect expenses necessary to support
Manufacturing of Licensed Compound or Licensed Product and depreciation,
purchase price variances and other manufacturing variances, utilities,
manufacturing management and administration costs, general supplies,
transportation, warehouse equipment and IT, maintenance, repair and installation
costs, costs of other plant services (waste treatment, waste incineration),
ongoing stability program costs, technical services (process design and process
improvement), and security, in each case to the extent reasonably allocable to
the Licensed Compound or Licensed Product, and (iv) direct write-offs for
inventory adjustments and losses due to expired, spoiled, damaged or otherwise
unsaleable Licensed Compound or Licensed Product (but excluding costs due to
negligence or willful misconduct of such Party or its Affiliates); but excluding
(w) costs and charges related to

 

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or occasioned by unused manufacturing capacity, (x) the manufacture of other
products at such Party’s manufacturing facilities, (y) amortization of property,
plant or equipment not reasonably related to Manufacturing of Licensed Compound
or Licensed Product hereunder, and (z) allocation of general corporate overhead
or other administrative costs or expenses not directly or indirectly involved in
the management of manufacturing, material procurement or product distribution
for Licensed Compound or Licensed Product; and

(b) with respect to Manufacturing activities conducted by Third Parties for such
Party or its Affiliates, “fully allocated costs” shall consist of the invoiced
costs and charges of suppliers of goods and services directly related to such
Manufacturing activities.

1.21 “Cover”, “Covering” or “Covered” means, with respect to a product,
composition, technology, process or method that, in the absence of ownership of
or a license granted under a Valid Claim, the Manufacture, use, offer for sale,
sale or importation of such product or composition, or the practice of such
technology, process or method, would infringe such Valid Claim (or, in the case
of a Valid Claim that has not yet issued, would infringe such Valid Claim if it
were to issue).

1.22 “Develop” or “Development” means discovery, research, preclinical
development, clinical development with respect to a product, including
identification, characterization, optimization, non-clinical testing,
pharmacology studies, toxicology studies, formulation, chemical analysis,
bioanalytical analysis, material performance studies (such as measurements of
stability, physical form, dissolution, or visual or spectroscopic analysis, and
the like), Manufacturing process development and scale-up (including active
pharmaceutical ingredient and drug product production), Manufacturing
pre-clinical and clinical supplies for the foregoing activities, quality
assurance and quality control, technical support, pharmacokinetic studies,
clinical studies, interacting with Regulatory Authorities regarding the
foregoing, and all other activities relating to seeking, obtaining or
maintaining any Regulatory Approvals for such product from the FDA or any other
applicable Regulatory Authority.

1.23 “Development Costs” means, with respect to Development activities performed
by or on behalf of a Party hereunder, all costs and expenses of such Party and
its Affiliates that are paid or payable to Third Parties and specifically
associated with the conduct of such activities. For clarity, Development Costs
shall not include internal costs of a Party or its Affiliates with respect to
Development activities, including costs with respect to the employees of such
Party or its Affiliates, and costs and expenses of the kinds that are normally
included in full-time equivalent rates for internal personnel.

1.24 “Diagnostic Know-How” means Know-How that is necessary or reasonably useful
to Develop or Commercialize any Diagnostic Product in the Field in the
Territory.

1.25 “Diagnostic Patents” means Patents claiming or directed to Diagnostic
Know-How.

1.26 “Diagnostic Product” means any biomarker or diagnostic assay or test that
is designed for use with, or that relates to, is associated with or is
correlated with patient populations that do or do not respond to treatment with,
a particular Therapeutic Product or Veterinary Product, as applicable.

 

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1.27 “Dollars” or “$” means the legal tender of the U.S.

1.28 “EISAI Collaboration IP” means EISAI Collaboration Know-How and EISAI
Collaboration Patents.

1.29 “EISAI Collaboration Know-How” means Know-How that is discovered,
developed, invented, conceived or reduced to practice solely by or on behalf of
EISAI or its Affiliates or Sublicensees pursuant to the conduct of activities
under the Collaboration or in the exercise of EISAI’s licenses under this
Agreement from and after the Prior Agreement Effective Date (it being understood
that any activities carried out by or on behalf of EPIZYME, its Affiliates or
Sublicensees under the Collaboration shall not be construed or interpreted to be
carried out by or on behalf of EISAI, its Affiliates or Sublicensees for
purposes hereof).

1.30 “EISAI Collaboration Patents” means Patents claiming or directed to EISAI
Collaboration Know-How.

1.31 “EISAI IP” means EISAI Know-How and EISAI Patents.

1.32 “EISAI Know-How” means Know-How that (a) is Controlled by EISAI as of the
Prior Agreement Effective Date or at any time thereafter prior to the expiration
of the Target Exclusivity Period, (b) arises outside of the Collaboration, and
(c) is necessary or reasonably useful for the Development, Manufacture or
Commercialization of Licensed Compounds and Licensed Products in the Field in
the Territory, but expressly excluding any Know-How Controlled by EISAI that
relates to any compound or molecule that is not a Compound directed to EZH2. For
purposes of clarity, EISAI Know-How includes Diagnostic Know-How Controlled by
EISAI as of the Prior Agreement Effective Date or at any time thereafter prior
to the expiration of the Target Exclusivity Period, but excludes any
Collaboration Know-How owned by EISAI and EISAI’s interest in any Joint
Know-How.

1.33 “EISAI Patent(s)” means Patents that (a) are Controlled by EISAI as of the
Prior Agreement Effective Date or at any time thereafter prior to the expiration
of the Target Exclusivity Period, (b) arise outside of the Collaboration, and
(c) claim or are directed to EISAI Know-How, but expressly excluding any Patent
that claims or is directed to the composition of matter of any compound or
molecule that is not a Compound directed to EZH2. For purposes of clarity, EISAI
Patents include Diagnostic Patents Controlled by EISAI as of the Prior Agreement
Effective Date or at any time thereafter prior to the expiration of the Target
Exclusivity Period, but exclude Collaboration Patents owned by EISAI and EISAI’s
interest in any Joint Patents.

1.34 “EISAI Territory” means Japan.

1.35 “EMA” means the European Medicines Agency, and any successor entity
thereto.

1.36 “EPIZYME Collaboration IP” means EPIZYME Collaboration Know-How and EPIZYME
Collaboration Patents.

 

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1.37 “EPIZYME Collaboration Know-How” means Know-How that is discovered,
developed, invented, conceived or reduced to practice solely by or on behalf of
EPIZYME or its Affiliates or Sublicensees pursuant to the conduct of activities
under the Collaboration or in the exercise of EPIZYME’s licenses under this
Agreement from and after the Prior Agreement Effective Date (it being understood
that any activities carried out by or on behalf of EISAI, its Affiliates or
Sublicensees under this Agreement shall not be construed or interpreted to be
carried out by or on behalf of EPIZYME, its Affiliates or Sublicensees for
purposes hereof).

1.38 “EPIZYME Collaboration Patents” means Patents claiming or directed to
EPIZYME Collaboration Know-How.

1.39 “EPIZYME IP” means EPIZYME Know-How and EPIZYME Patents.

1.40 “EPIZYME Know-How” means Know-How that (a) is Controlled by EPIZYME as of
the Prior Agreement Effective Date or at any time thereafter prior to the
expiration of the Target Exclusivity Period, (b) arises outside of the
Collaboration, and (c) is necessary or reasonably useful for the Development,
Manufacture or Commercialization of Licensed Compounds and Licensed Products in
the Field in the Territory, but expressly excluding any Know-How Controlled by
EPIZYME that relates to any compound or molecule that is not a Compound directed
to EZH2. For purposes of clarity, EPIZYME Know-How includes Diagnostic Know-How
Controlled by EPIZYME as of the Prior Agreement Effective Date or at any time
thereafter prior to the expiration of the Target Exclusivity Period, but
excludes Collaboration Know-How owned by EPIZYME and EPIZYME’s interest in any
Joint Know-How.

1.41 “EPIZYME Patents” means:

(a) the patents and patent applications listed on Exhibit A;

(b) any substitutions, divisionals, continuations, continuations-in-part,
provisional applications, reissues, renewals, registrations, confirmations,
re-examinations, extensions, supplementary protection certificates and the like
of any patents or patent applications set forth on Exhibit A;

(c) foreign counterparts of any of the foregoing in clause (a) or (b); and

(d) Patents other than those included in the foregoing clauses (a) through
(c) that are Controlled by EPIZYME as of the Prior Agreement Effective Date or
at any time thereafter prior to the expiration of the Target Exclusivity Period
and arise outside of the Collaboration, that claim or are directed to EPIZYME
Know-How, but expressly excluding any Patent that claims or is directed to the
composition of matter of any compound or molecule that is not a Compound
directed to EZH2.

For purposes of clarity, EPIZYME Patents include Diagnostic Patents Controlled
by EPIZYME as of the Prior Agreement Effective Date or at any time thereafter
prior to the expiration of the Target Exclusivity Period, but exclude
Collaboration Patents owned by EPIZYME and EPIZYME’s interest in any Joint
Patents.

 

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1.42 “EPIZYME Territory” means the entire world other than Japan.

1.43 “EU” means all countries that are officially recognized as member states of
the European Union at any particular time during the Term.

1.44 “Executive Officers” means EPIZYME’s Chief Executive Officer and EISAI’s
President of its Oncology Product Creation Unit.

1.45 “EZH2” means catalytic subunit of Polycomb repressive complex 2 (PRC2),
which is a highly conserved histone methyltransferase that targets lysine-27 of
histone H3.

1.46 “EZH2 Compound(s)” means any Compound(s) that:

(a) is directed to EZH2; and

(b) has an in vitro IC50 potency with a numerical value of [**] and [**]
selectivity relative to the next most active HMT target, other than EZH1.

1.47 “FDA” means the U.S. Food and Drug Administration, and any successor entity
thereto.

1.48 “Field” means the treatment, prevention, palliation or diagnosis of any
human or veterinary disease, disorder or condition.

1.49 “First Commercial Sale” means, with respect to each Licensed Product in a
country in the EPIZYME Territory or EISAI Territory, the first sale for which
revenue has been recognized by the Applicable Commercialization Party or its
Affiliates or Sublicensees for use or consumption by the general public of such
Licensed Product in such country after Regulatory Approval (and pricing or
reimbursement approval, if legally required for such sale) for such Licensed
Product has been obtained in such country; provided, however, that the following
shall not constitute a First Commercial Sale:

(a) any sale to an Affiliate or Sublicensee unless the Affiliate or Sublicensee
is the last entity in the distribution chain of the Licensed Product;

(b) any use of such Licensed Product in Clinical Trials, non-clinical activities
or other Development activities, or disposal or transfer of Licensed Products
for a bona fide charitable purpose; and

(c) treatment IND sales, named patient sales, or compassionate use.

1.50 “Global Development Plan” means the development plan approved by the JSC
that sets forth the Development activities of EPIZYME with respect to
Therapeutic Product(s) and related Diagnostic Product(s), as such plan may be
amended from time to time in accordance with the terms hereof.

 

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1.51 “GLP” means the then-current good laboratory practice standards promulgated
or endorsed by the FDA, as defined in U.S. 21 C.F.R. Part 58 (or such other
comparable regulatory standards in jurisdictions outside the U.S.).

1.52 “IND” means an investigational new drug application submitted to the FDA
pursuant to Part 312 of Title 21 of the U.S. Code of Federal Regulations,
including any amendments thereto. References herein to IND shall include, to the
extent applicable, any comparable filing(s) outside the U.S. for the
investigation of any product in any other country or group of countries (such as
a Clinical Trial Application (“CTA”) in the EU).

1.53 “Indication” means any human disease or condition, or sign or symptom of a
human disease or condition.

1.54 “Initiate” or “Initiation” means, with respect to a Clinical Trial, the
first dosing of the first subject enrolled in such Clinical Trial with a
Therapeutic Product.

1.55 “Japan Development Plan” means the development plan approved by the JSC
that sets forth Japan-Specific Development Activities of EISAI with respect to
Therapeutic Product(s), as such plan may be amended from time to time in
accordance with the terms hereof.

1.56 “Japan-Specific Development Activities” means, with respect to a Licensed
Product, such Development activities the primary purpose of which is to obtain
or maintain Regulatory Approval of such Licensed Product in Japan.

1.57 “Joint IP” means Joint Know-How and Joint Patents.

1.58 “Joint Know-How” means Know-How that is jointly discovered, developed,
invented, conceived or reduced to practice by one or more employees, agents or
consultants of EPIZYME, its Affiliates or Sublicensees, on the one hand, and one
or more employees, agents or consultants of EISAI, its Affiliates of
Sublicensees on the other hand, pursuant to the conduct of activities under the
Collaboration or in the exercise of each Party’s licenses under this Agreement
from and after the Prior Agreement Effective Date.

1.59 “Joint Patent(s)” means Patents that claim or are directed to Joint
Know-How.

1.60 “Know-How” means all tangible and intangible:

(a) information, techniques, technology, practices, trade secrets, inventions
(whether patentable or not), methods, knowledge, know-how, skill, experience,
data, results (including pharmacological, toxicological, pre-clinical and
clinical test data and results, research data, reports and batch records),
analytical and quality control data, analytical methods (including applicable
reference standards), full batch documentation, packaging records, release,
stability, storage and shelf-life data, and Manufacturing process information,
results or descriptions, software and algorithms; and

(b) compositions of matter, cells, cell lines, assays, animal models and
physical, biological or chemical material;

 

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in each case ((a) and (b)) that is not generally known.

As used in this Agreement, “clinical test data” shall be deemed to include all
information related to clinical testing, including patient report forms,
investigators’ reports, biostatistical, pharmaco-economic and other related
analyses, regulatory filings and communications, and the like.

1.61 “Law” or “Laws” means all applicable laws, statutes, rules, regulations,
orders, judgments, or ordinances having the effect of law of any federal,
national, multinational, state, provincial, county, city or other political
subdivision.

1.62 “Licensed Compound(s)” means any EZH2 Compound(s) that is:

(a) synthesized or identified by either Party (or by any of its respective
Affiliates or any Third Party working with or on behalf of such Party or any of
its respective Affiliates) or jointly by or on behalf of the Parties in the
conduct of the Collaboration or in the exercise of such Party’s licenses under
this Agreement from and after the Prior Agreement Effective Date, excluding
Compounds Controlled by either Party and first identified as EZH2 Compounds
after the expiration of the Target Exclusivity Period; or

(b) otherwise Controlled by EPIZYME as of the Prior Agreement Effective Date or
at any time thereafter prior to the expiration of the Target Exclusivity Period.

1.63 “Licensed Product” means any Therapeutic Product, any Diagnostic Product or
any Veterinary Product, as applicable.

1.64 “MAA” means a regulatory application filed with the EMA or MHLW seeking
Regulatory Approval of a Licensed Product, and all amendments and supplements
thereto filed with the EMA or MHLW.

1.65 “Major EU Country” means any of the following countries: France, Germany,
Italy, Spain or the United Kingdom. “Major EU Countries” means all of the
foregoing countries.

1.66 “Major Market Country(ies)” means (a) the United States, (b) Japan or
(c) one (or more) of the Major EU Countries.

1.67 “Manufacture” or “Manufacturing” means, as applicable, all activities
associated with the production, manufacture, supply, processing, filling,
packaging, labeling, shipping, and storage of a Licensed Compound, Licensed
Product or any components thereof, including manufacturing process and
formulation development and scale-up (including active pharmaceutical ingredient
and drug production), manufacturing process validation, stability testing,
preclinical, clinical and commercial manufacture and analytical development,
product characterization, quality assurance and quality control development,
testing and release.

1.68 “MHLW” means the Ministry of Health, Labour and Welfare of Japan, or the
Pharmaceuticals and Medical Devices Agency, or any successor to either of them,
as the case may be.

 

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1.69 “NDA” means a New Drug Application (as more fully described in 21 C.F.R.
314.50 et seq. or its successor regulation) and all amendments and supplements
thereto filed with the FDA, or any equivalent filing, including an MAA, in a
country or regulatory jurisdiction other than the United States.

1.70 “Net Sales” means with respect to any Licensed Product for any period, the
gross amounts invoiced by the Applicable Commercialization Party, its Affiliates
and Sublicensees (each, a “Selling Party”) to Third Party customers for sales of
such Licensed Product during such period, less the following deductions actually
incurred, allowed, paid, accrued or specifically allocated in its financial
statements in accordance with GAAP, for:

(a) customary and reasonable trade, quantity, and cash discounts, wholesaler
allowances and inventory management fees;

(b) customary and reasonable credits, rebates and chargebacks (including those
to managed-care entities and government agencies), and allowances or credits to
customers on account of rejection or returns (including wholesaler and retailer
returns) or on account of retroactive price reductions affecting such Licensed
Product;

(c) freight, postage and duties, and transportation charges relating to such
Licensed Product, including handling and insurance therefor;

(d) sales (such as VAT or its equivalent) and excise taxes, other consumption
taxes, and customs duties (excluding any taxes paid on the income from such
sales) to the extent the Selling Party is not otherwise entitled to a credit or
a refund for such taxes, duties or payments made; and

(e) amounts previously included in Net Sales that are written-off by the Selling
Party as uncollectible in accordance with the standard practices of such Selling
Party for writing off uncollectible amounts, consistently applied; provided,
however, that if any such written-off amounts are subsequently collected, such
collected amounts shall be included in Net Sales in the period in which they are
subsequently collected.

If non-monetary consideration is received for any Licensed Product in any
country, Net Sales will be calculated based on the average price charged for
such Licensed Product in such country during the preceding Calendar Quarter, or
in the absence of such sales, the fair market value of the Licensed Product in
such country, as determined by the Parties in good faith. If the Parties are
unable to reach such an agreement, the Parties will refer such matter to a
jointly selected Third Party with expertise in the pricing of pharmaceutical
products that is not an employee, consultant, legal advisor, officer, director
or stockholder of, and does not have any conflict of interest with respect to,
either Party for resolution. If the Parties are unable to agree on such a Third
Party expert within thirty (30) days after a Party has notified the other Party
that it desires to refer such matter to such a Third Party for resolution,
either Party may request that the New York, New York office of the American
Arbitration Association (“AAA”) appoint such an expert to resolve such matter.
The resolution determined by any such expert that is either jointly selected or
appointed by the AAA shall be final and binding on the Parties. Notwithstanding
anything to the contrary herein, the transfer, disposal or use of Licensed
Product, without

 

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consideration, for marketing, regulatory, development or charitable purposes,
such as sampling, clinical trials, preclinical trials, compassionate use, named
patient use, or indigent patient programs, shall not be deemed a sale hereunder.

Net Sales shall be determined on, and only on, the first sale by a Party or any
of its Affiliates or Sublicensees to a non-Sublicensee Third Party.

Each Party shall not, and shall cause its Selling Parties not to, use any
Licensed Product as a loss leader or otherwise unfairly or inappropriately
discount the gross invoiced sales price of a Licensed Product in a manner that
is intended to benefit, or provide an incentive to enhance sales of, any other
pharmaceutical product sold by such Party or any of its Selling Parties. Sales
of a Licensed Product between a Party and any of its Selling Parties for resale
shall be excluded from the computation of Net Sales, but the subsequent resale
of such Licensed Product to a non-Sublicensee Third Party shall be included
within the computation of Net Sales. In addition, sales of a Licensed Product by
one Party or its Affiliates or Sublicensees to the other Party or its Affiliates
or Sublicensees pursuant to a mutually agreed Manufacturing and supply
relationship shall be excluded from the computation of Net Sales, but the
subsequent resale of such Licensed Product by the purchasing Party or its
Affiliate or Sublicensee to a non-Sublicensee Third Party shall be included
within the computation of Net Sales.

If a Therapeutic Product is sold as part of a Combination Product (as defined
below) in any country, Net Sales for such country for any period will be the
product of (i) Net Sales of the Combination Product calculated as above in such
country for such period (i.e., calculated as for a non-Combination Product) and
(ii) the fraction (A/(A+B)), where:

“A” is the average wholesale acquisition cost in such country of the Therapeutic
Product comprising a Licensed Compound as the sole therapeutically active
ingredient during such period; and

“B” is the average wholesale acquisition cost in such country of the other
therapeutically active ingredients contained in the Combination Product when
sold separately during such period.

If “A” or “B” cannot be determined by reference to non-Combination Product sales
as described above, then Net Sales for purposes of determining royalty payments
will be calculated as above, but the average wholesale acquisition cost in the
above equation shall be determined by mutual agreement reached in good faith by
the Parties prior to the end of the accounting period in question based on an
equitable method of determining the same that takes into account, in the
applicable country, variations in dosage units and the relative fair market
value of each therapeutically active ingredient in the Combination Product. If
the Parties are unable to reach such an agreement prior to the end of the
applicable accounting period, then the Parties will refer such matter to a
jointly selected Third Party with expertise in the pricing of pharmaceutical
products that is not an employee, consultant, legal advisor, officer, director
or stockholder of, and does not have any conflict of interest with respect to,
either Party for resolution. If the Parties are unable to agree on such a Third
Party expert within thirty (30) days after a Party has notified the other Party
that it desires to refer such matter to such a Third Party for resolution,
either Party may request that the New York, New York office of the AAA appoint
such an expert to resolve such matter. The resolution determined by any such
expert that is either jointly selected or appointed by the AAA shall be final
and binding on the Parties.

 

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As used in this Section 1.70, “Combination Product” means a Therapeutic Product
that contains one or more additional active ingredients (whether coformulated or
copackaged) that are not Licensed Compounds. Pharmaceutical dosage form
vehicles, adjuvants and excipients shall be deemed not to be “active
ingredients.”

1.71 “Patents” means (a) all national, regional and international patents and
patent applications, including provisional patent applications, (b) all patent
applications filed either from such patents, patent applications or provisional
applications or from an application claiming priority from either of these,
including divisionals, continuations, continuations-in-part, provisionals,
converted provisionals and continued prosecution applications, (c) any and all
patents that have issued or in the future issue from the foregoing patent
applications ((a) and (b)), including utility models, petty patents and design
patents and certificates of invention, (d) any and all extensions or
restorations by existing or future extension or restoration mechanisms,
including revalidations, reissues, re-examinations and extensions (including any
supplementary protection certificates and the like) of the foregoing patents or
patent applications ((a), (b), and (c)), and (e) any similar rights, including
so-called pipeline protection or any importation, revalidation, confirmation or
introduction patent or registration patent or patent of additions to any of such
foregoing patent applications and patents.

1.72 “Patent-Based Exclusivity” means, with respect to a Licensed Product in a
country in the Territory, that at least one Valid Claim of the EPIZYME Patents,
the EISAI Patents that Cover the composition of matter of the applicable
Licensed Compound, the Collaboration Patents or the Joint Patents Covers such
Licensed Product in such country.

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

1.74 “Phase 1 Clinical Trial” means a human clinical trial of a product in any
country, the principal purpose of which is a preliminary determination of safety
in healthy individuals or patients, that would satisfy the requirements of 21
C.F.R. 312.21(a), or a similar clinical study prescribed by the relevant
Regulatory Authorities in a country other than the United States.

1.75 “Phase 2 Clinical Trial” means a human clinical trial of a product in any
country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is
intended to explore a variety of doses, dose response, and duration of effect,
and to generate initial evidence of clinical safety and activity in a target
patient population, or a similar clinical study prescribed by the relevant
Regulatory Authorities in a country other than the United States.

1.76 “Phase 3 Clinical Trial” means a human clinical trial of a product in any
country that would satisfy the requirements of 21 C.F.R. 312.21(c) and is
intended to (a) establish that the product is safe and efficacious for its
intended use, (b) define warnings, precautions and adverse reactions that are
associated with the product in the dosage range to be prescribed, and
(c) support Regulatory Approval for such product.

 

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1.77 “Prosecution and Maintenance” or “Prosecute and Maintain” means, with
regard to a Patent, the preparation, filing, prosecution and maintenance of such
Patent, as well as re-examinations, reissues, appeals, and requests for patent
term adjustments with respect to such Patent, together with the initiation or
defense of interferences, the initiation or defense of oppositions and other
similar proceedings with respect to the particular Patent, and any appeals
therefrom. For clarification, “Prosecution and Maintenance” or “Prosecute and
Maintain” shall not include any other defense or enforcement actions taken with
respect to a Patent.

1.78 “PRV” means a priority review voucher awarded by FDA pursuant to
Section 524 or Section 529 of the FFDCA.

1.79 “Regulatory Approval” means, with respect to a country in the Territory,
the approval, license or authorization of the applicable Regulatory
Authority(ies) necessary for the marketing and sale of a pharmaceutical product
for a particular Indication in such country in the Territory, excluding separate
pricing or reimbursement approvals that may be required.

1.80 “Regulatory Authority” means, with respect to a country in the Territory,
any national, regional, state or local regulatory agency, department, bureau,
commission, council or other governmental entity that regulates or otherwise
exercises authority with respect to the Development, Manufacture, marketing,
sale, distribution, use or other exploitation of pharmaceutical products in such
country, including the FDA, the EMA and the MHLW, and any successor(s) thereto.

1.81 “Regulatory-Based Exclusivity” means, with respect to a Licensed Product in
a country in the Territory, that (a) the Applicable Commercialization Party or
any of its Affiliates or Sublicensees has been granted the exclusive legal right
by a Regulatory Authority (or is otherwise entitled to the exclusive legal right
by operation of Law) in such country to market and sell the Licensed Product or
the active ingredient comprising such Licensed Product in such country, or
(b) the data and information submitted by the Applicable Commercialization Party
or any of its Affiliates or Sublicensees to the relevant Regulatory Authority in
such country for purposes of obtaining Regulatory Approval may not be disclosed,
referenced or relied upon in any way by such Regulatory Authority (including by
relying upon the Regulatory Authority’s previous findings regarding the safety
or effectiveness of the Licensed Product) to support the Regulatory Approval or
marketing of any product by a Third Party in such country.

1.82 “Regulatory Dossier” means the technical, medical and scientific
registrations, authorizations and approvals (including approvals of NDAs,
supplements and amendments, pre- and post- approvals, pricing and Third Party
reimbursement approvals, and labeling approvals) of any Regulatory Authority
necessary for the Development (including the conduct of clinical studies),
Manufacture, distribution, marketing, promotion, offer for sale, use, import,
reimbursement, export or sale of a product in a regulatory jurisdiction,
together with all related correspondence to or from any Regulatory Authority and
all documents referenced in the complete regulatory chronology for each NDA,
including all Regulatory Materials and drug master file(s) (if any).

1.83 “Regulatory Materials” means regulatory applications, notifications,
registrations, Regulatory Approvals or other submissions made to or with a
Regulatory Authority that are

 

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necessary or reasonably desirable in order to Develop, Manufacture, market, sell
or otherwise Commercialize a product in a particular country, territory or
possession. Regulatory Materials include INDs, CTAs, NDAs and MAAs, and
amendments and supplements to any of the foregoing, and applications for pricing
approvals.

1.84 “ROW” means all countries in the world other than Japan.

1.85 “Sublicensee” means (a) a Third Party to whom the Applicable
Commercialization Party has granted a license or a sublicense pursuant to
Section 5.1.2 or Section 5.2.2 to Develop or Commercialize Licensed Compounds or
Licensed Products in the Field, excluding any Third Party acting solely as a
distributor and (b) with respect to EPIZYME, a Third Party to whom EPIZYME has
granted a license under the EPIZYME IP, EPIZYME Collaboration IP or EPIZYME’s
interest in the Joint IP to Develop or Commercialize Licensed Compounds or
Licensed Products in the Field in the EPIZYME Territory, excluding any Third
Party acting solely as a distributor.

1.86 “Target Exclusivity Period” means the period commencing on the Prior
Agreement Effective Date and ending on the date that is eight years after the
First Commercial Sale of any Licensed Product in a first country in the
Territory.

1.87 “Territory” means the EPIZYME Territory and the EISAI Territory
collectively.

1.88 “Therapeutic Product” means any human therapeutic, prophylactic or
palliative pharmaceutical product comprising a Licensed Compound, whether or not
as the sole active ingredient, and in any dosage form or formulation.

1.89 “Third Party” means any Person other than EPIZYME or EISAI that is not an
Affiliate of EPIZYME or of EISAI.

1.90 “UNC” means The University of North Carolina at Chapel Hill.

1.91 “UNC License Agreement” means the License Agreement, dated January 7, 2008,
between UNC and EPIZYME.

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

1.93 “Valid Claim” means:

(a) a claim of an issued patent in the U.S. or in a jurisdiction outside the
U.S., that has not expired, lapsed, been cancelled or abandoned, or been
dedicated to the public, disclaimed, or held unenforceable, invalid, or
cancelled by a court or administrative agency of competent jurisdiction in an
order or decision from which no appeal has been or can be taken, including
through opposition, reexamination, reissue or disclaimer; or

(b) a claim of a pending patent application that has not been finally abandoned
or finally rejected and which has been pending for no more than [**] years from
the date of filing of the earliest priority patent application to which such
pending patent application is entitled to claim benefit.

 

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For clarity, a claim of an issued patent that ceased to be a Valid Claim before
it issued because it had been pending too long, but subsequently issued and is
otherwise described by clause (a) of the foregoing sentence shall again be
considered to be a Valid Claim once it issues. The same principle shall apply in
similar circumstances such as if, for example (but without limitation), a final
rejection of a claim is overcome.

1.94 “Veterinary Product” means any therapeutic, prophylactic or palliative
pharmaceutical product comprising a Licensed Compound, whether or not as the
sole active ingredient, for veterinary use and in any dosage form or
formulation.

1.95 Additional Definitions. Each of the following definition is set forth in
the section of this Agreement indicated below:

 

Definition:

  

Section:

AAA    1.70 Alliance Manager    4.2 Amended CDx Letter Agreement    Recitals
Arbitration Request    14.2 Breaching Party    13.3.1(a) Chairperson    4.1.1
Collaboration    2.1 Combination Product    1.70 Competing Business    7.2.1
Competitive Infringement    8.5.1 Compulsory Third Party Product    6.4.3
Confidential Information    9.1 CREATE Act    8.2.6 CTA    1.52 Disclosing Party
   9.1 EISAI    Preamble EISAI Patent Challenge    12.4(b) EPIZYME    Preamble
Excess Eisai Value    12.5.2(i) Existing Confidentiality Agreement    9.5
Existing Know-How    10.2.3 Existing Patents    10.2.1 Existing RMS Agreement   
Recitals FFDCA    10.1.6 GAAP    13.15 HMT    Recitals Indemnified Party   
11.3.1 Indemnifying Party    11.3.1 JSC    4.1 Key Employee    13.13

 

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Definition:

  

Section:

Losses    11.1 Marketing-Related Materials    12.5.1(g) Negotiating Period   
5.6 Non-Breaching Party    12.3.1(a) Party or Parties    Preamble Payee    6.6
Payor    6.6 Prior Agreement    Recitals Prior Agreement Effective Date   
Recitals Product Information    9.2 PRV    6.11 Receiving Party    9.1
Redemption Date    6.12.2 Royalty Term    6.4.2(a) SDEA    2.5.4 Selling Party
   1.70 Severed Clause    13.10 Subcommittee    4.1.6 Term    12.1.1 Third Party
Claims    11.1 Third Party Offer Notice    5.6

ARTICLE 2

COLLABORATION OVERVIEW; DEVELOPMENT ACTIVITIES

2.1 Collaboration Overview. Pursuant to this Agreement, the Parties have
collaborated on the conduct of global Development activities prior to the
Restatement Date, and after the Restatement Date EPIZYME shall continue to
conduct global Development activities with respect to Licensed Compounds and
Licensed Products and shall Commercialize the Licensed Products in the EPIZYME
Territory and EISAI shall conduct Japan-Specific Development Activities with
respect to Licensed Compounds and Licensed Products and shall Commercialize the
Licensed Products in the EISAI Territory (the “Collaboration”).

2.2 Development Activities.

2.2.1 Subject to EISAI’s sole right and responsibility to conduct Japan-Specific
Development Activities as set forth in Section 2.2.2, EPIZYME shall have the
sole right and responsibility for all global Development activities for Licensed
Products following the Restatement Date. EPIZYME shall use Commercially
Reasonable Efforts to conduct all such global Development activities in
accordance with the Global Development Plan.

(a) Not later than [**] days after the Restatement Date, EPIZYME shall provide a
proposed Global Development Plan to the JSC for review and approval pursuant to
Section 4.1.5.

 

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2.2.2 EISAI shall have the sole right and responsibility for all Japan-Specific
Development Activities for Licensed Products following the Restatement Date.
EISAI shall use Commercially Reasonable Efforts to conduct all such
Japan-Specific Development Activities in accordance with the Japan Development
Plan.

(a) Prior to the commencement of any Japan-Specific Development Activities,
EISAI shall provide a proposed Japan Development Plan to the JSC for review and
approval pursuant to Section 4.1.5.

2.2.3 EPIZYME shall submit to the JSC for its review and approval all proposed
amendments to the Global Development Plan, and EISAI shall submit to the JSC for
its review and approval all proposed amendments to the Japan Development Plan.

2.3 Reports; Results. Each Party shall provide to the other Party quarterly
written progress reports on the status of its Development activities under the
Collaboration, including summaries of data and results associated with such
Development activities, and (with respect to EPIZYME) progress toward completing
the milestones in Section 6.3 hereof, at least five (5) Business Days in advance
of each JSC meeting.

2.4 Subcontracting. Subject to the terms of this Agreement, each Party shall
have the right to engage Affiliates or Third Party subcontractors to perform its
obligations under this Agreement. Any Affiliate or subcontractor to be engaged
by a Party to perform a Party’s obligations set forth in this Agreement shall
meet the qualifications typically required by such Party for the performance of
work similar in scope and complexity to the subcontracted activity; provided
that any Party engaging an Affiliate or subcontractor hereunder shall remain
responsible and obligated for such activities.

2.5 Regulatory Matters; Compliance.

2.5.1 Compliance. Each Party agrees that in performing its obligations under
this Agreement, it shall perform such obligations in good scientific manner and
comply in all material respects with all applicable FDA and other applicable
current international regulatory requirements and standards, including (as
applicable) FDA’s cGMP, GLP and good clinical practices, and comparable foreign
regulatory standards, and other Laws.

2.5.2 Data Integrity. Each Party shall maintain, or cause to be maintained,
records of its Development activities pursuant to this Agreement in accordance
with Law, in sufficient detail and accuracy and in good scientific manner
appropriate for patent and regulatory purposes, and properly reflecting all work
done and results achieved in the performance of its Development activities. Such
records shall be retained by each Party for at least three (3) years after the
termination of this Agreement, or for such longer period as may be required by
Law. Each Party shall have the right, during normal business hours and upon
reasonable notice, to inspect and copy any such records, except to the extent
that a Party reasonably determines that such records contain Confidential
Information that is not licensed to the other Party, or to which the other Party
does not otherwise have a right hereunder.

 

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2.5.3 Regulatory Filings and Data. EPIZYME, at its sole cost, shall have the
right and responsibility, in consultation with EISAI, for preparing, filing and
maintaining all regulatory filings and Regulatory Approvals necessary for the
Development or Commercialization of Licensed Compounds and Licensed Products in
the Field in the EPIZYME Territory, including applicable INDs and NDAs. EPIZYME
shall own all such regulatory filings and Regulatory Approvals relating to the
EPIZYME Territory. EISAI, at its sole cost, shall have the right and
responsibility, in consultation with EPIZYME, for preparing, filing and
maintaining all regulatory filings and Regulatory Approvals necessary for
Japan-Specific Development Activities or Commercialization of Licensed Compounds
and Licensed Products in the Field in the EISAI Territory, including applicable
INDs and NDAs. EISAI shall own all such regulatory filings and Regulatory
Approvals relating to the EISAI Territory.

2.5.4 Adverse Event Reporting; Global Safety Database. EPIZYME, at its sole
cost, shall be solely responsible for reporting to applicable Regulatory
Authorities in the EPIZYME Territory all adverse drug experiences associated
with Licensed Compounds and Licensed Products in the Field. EISAI, at its sole
cost, shall be solely responsible for reporting to applicable Regulatory
Authorities in the EISAI Territory all adverse drug experiences associated with
Licensed Compounds and Licensed Products in the Field. The Parties shall
negotiate and agree to, within ninety (90) days following the Restatement Date,
a detailed safety data exchange agreement (the “SDEA”) setting forth reasonable
and customary procedures governing the collection, investigation, reporting and
exchange of information to enable collaboration on all matters of safety of use
of the Licensed Compounds and Licensed Products worldwide, including the
exchange of adverse drug experience information and similar matters sufficient
to permit each Party to comply with its reporting obligations under this
Section 2.5.4. EPIZYME, at its sole cost, shall establish, hold and maintain the
global pharmacovigilance database for the Licensed Compounds and Licensed
Products, and EISAI shall transfer all safety data in its possession as of the
Restatement Date to EPIZYME in accordance with Section 2.6.

2.6 Transition Matters.

2.6.1 Following the Restatement Date, the Parties shall use Commercially
Reasonable Efforts to perform the transfers and other transitional activities
set forth in Exhibit B on the timelines therefor specified in Exhibit B.

2.6.2 EPIZYME shall reimburse EISAI on a quarterly basis for (a) all internal
costs, including costs with respect to the employees of EISAI or its Affiliates,
that are incurred by EISAI and its Affiliates in the performance of the
transfers and other transitional activities set forth in Exhibit B solely to the
extent such internal costs are specifically identified under the “Costs
Associated” column in Exhibit B; (b) all reasonable, documented costs that are
paid or payable to Third Parties and incurred by EISAI and its Affiliates in the
performance of the transfers and other transitional activities set forth in
Exhibit B solely to the extent such costs are paid or payable to Third Parties
and are specifically identified under the “Costs Associated” column in Exhibit
B; and (c) with respect to any transfer or transitional activities which are not
set forth in Exhibit B but which EPIZYME requests and EISAI agrees to perform,
all internal costs (including costs with respect to the employees of EISAI or
its Affiliates) and any reasonable, documented costs that are paid or payable to
Third Parties and incurred by EISAI and its Affiliates in such performance,
provided that in the case of the foregoing clause (c): (1) costs

 

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shall only be reimbursed if EPIZYME has pre-approved such payments in writing;
and (2) internal costs shall be payable at a full-time equivalent rate of $[**]
USD/month (or $[**] USD/day) and, as part of the pre-approval by EPIZYME
pursuant to the foregoing clause (1), EISAI shall provide to EPIZYME its good
faith estimate of the internal cost it will incur prior to performing the
applicable transfer or transition activity. For the avoidance of doubt, EISAI
shall not be obligated to agree to perform any transfer or transitional
activities requested by EPIZYME under the foregoing clause (c). Following the
end of each Calendar Quarter in which any such costs are incurred, EISAI shall
provide EPIZYME with a written report and invoice setting forth in reasonable
detail all such costs incurred during the quarter. EPIZYME shall pay all
invoices within thirty (30) days of the invoice date. EISAI shall keep, and
shall require its Affiliates to keep, full, clear and accurate books and records
of all costs incurred by EISAI and its Affiliates for which reimbursement is
requested under this Section 2.6.2 for a period of at least three (3) years
following the end of the applicable quarter. EPIZYME shall have the right to
audit such books and records pursuant to the terms of Sections 6.8.2 and 6.8.3,
applied to this Section 2.6.2 mutatis mutandis.

ARTICLE 3

COMMERCIALIZATION ACTIVITIES; DILIGENCE; MANUFACTURING AND SUPPLY

3.1 Commercialization. On a Licensed Compound-by-Licensed Compound basis,
(a) EPIZYME, at its sole cost, either itself or by and through its Affiliates,
Sublicensees or contractors, shall have the sole right and responsibility for
all Commercialization activities in connection with such Licensed Compound, any
Therapeutic Product or Veterinary Product comprising such Licensed Compound and
any related Diagnostic Product(s) in the Field in the EPIZYME Territory, and
(b) EISAI, at its sole cost, either itself or by and through its Affiliates,
Sublicensees or contractors, shall have the sole right and responsibility for
all Commercialization activities in connection with such Licensed Compound, any
Therapeutic Product or Veterinary Product comprising such Licensed Compound and
any related Diagnostic Product(s) in the Field in the EISAI Territory. EPIZYME
shall book all sales of Licensed Products in the EPIZYME Territory and EISAI
shall book all sales of Licensed Products in the EISAI Territory.

3.2 Diligence.

3.2.1 EPIZYME shall use Commercially Reasonable Efforts (itself or through an
Affiliate or Sublicensee) to Develop, obtain Regulatory Approval for and
Commercialize at least [**] in each of the United States and the Major EU
Countries. For clarity, EPIZYME shall not have any obligation to use
Commercially Reasonable Efforts to Develop, obtain Regulatory Approval for or
Commercialize more than [**] in any country outside the United States and the
Major EU Countries.

3.2.2 EISAI shall use Commercially Reasonable Efforts (itself or through an
Affiliate or Sublicensee) to conduct Japan-Specific Development Activities for,
obtain Regulatory Approval for and Commercialize at least [**] in Japan;
provided that, if EPIZYME does not conduct such global Development activities
(excluding Japan-Specific Development Activities) as are necessary to submit an
application for Regulatory

 

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Approval for at least [**] in Japan or if EPIZYME does not comply with its
obligations under Section 3.3 and the supply agreement(s) contemplated thereby,
then EISAI shall, for the duration of EPIZYME’s noncompliance, be excused from
its obligations under this Section 3.2.2 to the extent the conduct of such
global Development activities or such compliance by EPIZYME is reasonably
necessary for EISAI to satisfy its obligations under this Section 3.2.2. For
clarity, EISAI shall not have any obligation to use Commercially Reasonable
Efforts to conduct Japan-Specific Development Activities for, obtain Regulatory
Approval for or Commercialize, more than [**] in Japan.

3.2.3 Subject to the foregoing obligations to use Commercially Reasonable
Efforts, neither Party provides any representation, warranty or guarantee that
the Collaboration will be successful or that any particular results will be
achieved with respect to the Collaboration, EZH2, or any Compound, Licensed
Compound or Licensed Product hereunder.

3.3 Manufacturing and Supply.

3.3.1 Subject to the terms and conditions of this Section 3.3, EPIZYME shall be
responsible for the Manufacture and supply of Licensed Compounds and Licensed
Products (including the active pharmaceutical ingredients thereof) for use for
Development and Commercialization purposes by EPIZYME in the EPIZYME Territory
and (unless EISAI elects to undertake such Manufacture and supply as set forth
in Section 3.3.2) by EISAI in the EISAI Territory during the Term.

3.3.2 EISAI shall have the right, but not the obligation, to elect to itself
Manufacture and supply or have Manufactured and supplied Licensed Compounds and
Licensed Products for use for Japan-Specific Development Activities and
Commercialization purposes by EISAI in the EISAI Territory during the Term upon
written notice to EPIZYME of such election, provided that if such notice is
provided after the date that is [**] prior to the projected date (as reasonably
determined by EISAI) of the first filing of an NDA for a Licensed Product in the
EISAI Territory, then: (i) unless otherwise agreed by the Parties, EISAI shall
continue to purchase from EPIZYME its requirements of Licensed Compounds and
Licensed Products for a period of [**] following such notice date (unless
EPIZYME fails to supply such requirements of Licensed Compounds and Licensed
Products as required under Section 3.3 and the supply agreement(s) contemplated
thereby); and (ii) EISAI shall reimburse EPIZYME for all EISAI
Territory-specific costs and expenses incurred by EPIZYME attributable to the
Manufacture and supply of Licensed Compounds and Licensed Products to EISAI and
not recovered through transfer pricing amounts paid by EISAI to EPIZYME prior to
such transition (such as, by way of example, costs incurred in meeting any
regulatory requirements relating to the EISAI Territory and translation costs).

3.3.3 Upon written request by either Party, the Parties shall in good faith
negotiate and enter into a clinical supply agreement pursuant to which EPIZYME
would Manufacture and supply to EISAI such quantity of Licensed Compounds and
Licensed Products as shall be reasonably requested by EISAI in writing in order
to conduct Japan-Specific Development Activities. Such clinical supply agreement
shall: (i) provide that EPIZYME shall Manufacture such Licensed Compounds and
Licensed Products in accordance with cGMP and other Law in the EISAI Territory
and the applicable specifications therefor, and shall deliver

 

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such Licensed Compounds and Licensed Products to EISAI FCA (Incoterms 2010)
EPIZYME’s (or its contract manufacturer’s) manufacturing facility; (ii) provide
that EISAI shall pay EPIZYME a purchase price equal to [**] for each such
delivery of Licensed Compounds and Licensed Products; (iii) provide that EPIZYME
shall invoice EISAI for the applicable purchase price promptly after delivery,
and EISAI shall pay such invoice not later than forty-five (45) days after
receipt thereof; and (iv) contain other reasonable and customary clinical supply
terms, including provisions addressing forecasting and ordering, delivery,
payment, acceptance and rejection procedures, regulatory assistance, warranties,
indemnification, limitations of liability and quality assurance and control.

3.3.4 Subject to EISAI’s right to make the election set forth in Section 3.3.2,
not later than one (1) year prior to the projected date (as reasonably
determined by EISAI) of receipt of the first Regulatory Approval of a Licensed
Product in the EISAI Territory, the Parties shall in good faith negotiate and
enter into a commercial supply agreement pursuant to which EPIZYME shall
Manufacture and supply to EISAI commercial quantities of finished, packaged
Licensed Products for sale and distribution in the EISAI Territory. Such
commercial supply agreement shall (a) provide that the purchase price for
Licensed Product supplied thereunder shall be equal to [**] percent ([**]%) of
EPIZYME’s Cost of Goods therefor and (b) contain other reasonable and customary
commercial supply terms, including provisions addressing forecasting and
ordering, delivery, payment, acceptance and rejection procedures, regulatory
assistance, warranties, indemnification, limitations of liability and quality
assurance and control.

ARTICLE 4

GOVERNANCE

4.1 Joint Steering Committee. The Parties have as of the Restatement Date
established a joint steering committee (the “JSC”) as more fully described in
this Section 4.1. The JSC shall have review, oversight and decision-making
responsibilities as more specifically provided herein. Each Party agrees to keep
the JSC informed of its progress and activities under the Collaboration. The JSC
may establish Subcommittees as set forth in Section 4.1.6.

4.1.1 Membership. The JSC shall be comprised of three (3) representatives (or
such other number of representatives as the Parties may agree) from each of
EISAI and EPIZYME. Each Party may replace any or all of its representatives on
the JSC at any time upon written notice to the other Party. Each representative
of a Party shall have sufficient seniority and expertise in the biotechnology
and pharmaceutical industry to participate on 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, provided that such substitute meets the foregoing
qualifications. Each Party may, subject to the other Party’s prior approval,
invite non-member representatives of such Party to attend meetings of the JSC as
non-voting participants, subject to the confidentiality obligations of Article
10. EPIZYME shall designate a chairperson (the “Chairperson”) to oversee the
operation of the JSC.

4.1.2 Meetings.

(a) The JSC shall meet at least twice each Calendar Year, or more or less
frequently as the Parties mutually deem appropriate, on such dates and at such
places and times

 

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as provided herein or as the Parties shall agree. Members of the JSC may attend
a meeting either in person or by telephone, video conference or similar means in
which each participant can hear what is said by, and be heard by, the other
participants; provided that at least one (1) JSC meeting per Calendar Year shall
be held in person.

(b) Meetings of the JSC that are held in person shall alternate between the
offices of the Parties, or such other location as the Parties may agree, with
the first meeting after the Restatement Date held at the offices of EPIZYME. The
members of the JSC also may convene or be polled or consulted from time to time
by electronic mail or correspondence, as deemed necessary or appropriate. A
quorum of the JSC shall exist whenever there is present at a meeting at least
one (1) representative appointed by each Party. Each Party will bear all
expenses it incurs in regard to participating in all meetings of the JSC,
including all travel and living expenses.

4.1.3 Minutes. The Alliance Manager from one of the Parties, on an alternating
basis, shall be responsible for preparing and circulating minutes of each
meeting of the JSC, setting forth, inter alia, an overview of the discussions at
the meeting and a list of any actions, decisions or determinations approved by
the JSC. Such minutes shall be effective only after approval by both Parties in
writing (which may be by electronic mail). Definitive minutes of all JSC
meetings shall be finalized no later than thirty (30) days after the meeting to
which the minutes pertain.

4.1.4 Responsibilities. The JSC shall perform the following functions:

(a) review and monitor progress of the Collaboration;

(b) review and approve the initial Global Development Plan and any amendments
thereto;

(c) review and approve the initial Japan Development Plan and any amendments
thereto;

(d) serve as a forum for exchange of information and to facilitate discussions
regarding the conduct of the Collaboration hereunder;

(e) attempt to resolve any disputes in any Subcommittee; and

(f) such other responsibilities as may be assigned to the JSC pursuant to this
Agreement or as may be mutually agreed upon by the Parties from time to time.

Each Party shall retain the rights, powers, and discretion granted to it under
this Agreement and no such rights, powers, or discretion shall be delegated to
or vested in the JSC unless such delegation or vesting of rights is expressly
provided for in this Agreement or the Parties expressly so agree in writing. For
clarity, the JSC shall not have any authority beyond the specific matters set
forth in this Section 4.1.4, and in particular shall not have any power to amend
or modify the terms of this Agreement. In any case where a matter within the
JSC’s authority arises, the JSC shall convene a meeting and consider such matter
within thirty (30) days after the matter is first brought to the JSC’s
attention, or, if earlier, at the next regularly-scheduled JSC meeting.

 

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4.1.5 Decisions. Except as otherwise provided herein, all decisions of the JSC
shall be made by consensus, with each Party collectively having one vote. The
Parties shall use good faith, reasonable efforts to attempt to reach consensus
on each matter submitted to the JSC. If the JSC cannot agree on a matter within
the JSC’s authority within ten (10) Business Days after it has met and attempted
to reach such decision, then (a) EISAI shall have the right to determine the
resolution of such matters relating to the Japan Development Plan and to
Japan-Specific Development Activities, regulatory and Commercialization issues
in the EISAI Territory and, to the extent EISAI has assumed Manufacturing
responsibility for the EISAI Territory in accordance with Section 3.3.2,
Manufacturing issues relating to the EISAI Territory in its sole discretion, and
(b) EPIZYME shall have the right to determine the resolution of all other
matters, including matters relating to the Global Development Plan and to global
Development, Manufacturing, regulatory and Commercialization issues, in its sole
discretion.

4.1.6 Subcommittee(s). From time to time, the JSC may establish subcommittees to
oversee particular projects or activities, as it deems necessary or advisable
(each, a “Subcommittee”). Each Subcommittee shall consist of such number of
members as the JSC determines is appropriate from time to time. Such members
shall be individuals with expertise and responsibilities in the relevant areas
such as non-clinical Development, pharmacology, clinical Development, Patents,
process sciences, Manufacturing, quality and regulatory affairs, as applicable
to the stage of the project or activity.

4.2 Alliance Managers. Each Party has appointed an individual to act as alliance
manager for such Party (each, an “Alliance Manager”). The Alliance Managers
shall be the primary point of contact for the Parties regarding the activities
contemplated by this Agreement and shall facilitate all such activities
hereunder. The Alliance Managers shall attend all meetings of the JSC and shall
be responsible for assisting the JSC in performing its oversight
responsibilities. The name and contact information for any Alliance Manager
replacement(s) chosen by EPIZYME or EISAI, in their sole discretion, from time
to time, shall be promptly provided to the other Party in accordance with
Section 13.7.

4.3 Senior Management Meetings. Without limiting the generality of the foregoing
in this Article 4, the senior management of each Party, including, for EPIZYME,
the Chief Executive Officer, Chief Scientific Officer, Chief Development Officer
and other appropriate members of senior management of EPIZYME as may be
designated by EPIZYME, and, for EISAI, the President of the Oncology Product
Creation Unit and other appropriate members of senior management of EISAI as may
be designated by EISAI, shall meet in person once a year, at a time and location
to be mutually agreed by the Parties, to discuss the Collaboration, strategic
plans for Licensed Products, and other related matters.

ARTICLE 5

LICENSE GRANTS

5.1 License Grant To EISAI. Subject to the terms and conditions of this
Agreement:

5.1.1 Licensed Compounds and Licensed Products. EPIZYME hereby grants to EISAI
(a) an exclusive right and license (even as to EPIZYME and its Affiliates), with
the right to grant sublicenses (subject to Section 5.1.2), under the EPIZYME IP,
the EPIZYME

 

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Collaboration IP, and EPIZYME’s interest in the Joint IP, to obtain and maintain
Regulatory Approvals for, use, offer for sale, sell, import and otherwise
Commercialize (but excluding Manufacturing) Licensed Compounds and Licensed
Products in the Field in the EISAI Territory and (b) a non-exclusive right and
license, with the right to grant sublicenses (subject to Section 5.1.2), under
the EPIZYME IP, the EPIZYME Collaboration IP, and EPIZYME’s interest in the
Joint IP, to conduct and have conducted Japan-Specific Development Activities
and (if EISAI elects to assume Manufacturing responsibilities as set forth in
Section 3.3.2) to Manufacture and have Manufactured Licensed Compounds and
Licensed Products anywhere in the world solely for purposes of exercising the
rights and licenses granted in the foregoing clause (a).

5.1.2 EISAI’s Sublicensing Rights. EISAI shall have the right to grant
sublicenses under the rights granted to it under Section 5.1.1 without the prior
written consent of EPIZYME, to (a) any EISAI Affiliate, or (b) any Third Party.
EISAI shall provide EPIZYME with a fully-executed copy of any agreement
(redacted as necessary to protect confidential or commercially sensitive
information) reflecting any sublicense granted by EISAI under this
Section 5.1.2, other than sublicenses to Affiliates or Third Party service
providers engaged by EISAI in the ordinary course of business, promptly (but in
no event later than ten (10) days) after the execution thereof. Each sublicense
granted by EISAI under this Section 5.1.2 shall be subject to and consistent
with the terms and conditions of this Agreement. EISAI shall remain primarily
liable for, and shall guarantee the performance of, its Affiliates and
Sublicensees with respect to any sublicense granted pursuant to this
Section 5.1.2.

5.1.3 Marketing Materials. EPIZYME hereby grants to EISAI an exclusive right and
license, with the right to grant sublicenses (subject to Section 5.1.2), solely
in the EISAI Territory, to reproduce, distribute, display, use, modify and
exploit, directly or indirectly, all promotional materials used by EPIZYME in
the promotion of Licensed Products in the EPIZYME Territory solely for purposes
of exercising the rights and licenses granted in Section 5.1.1(a); provided
that: (i) neither EISAI nor any of its Affiliates or Sublicensees shall have any
right or license to reproduce, distribute, display, use, modify or exploit any
corporate name or logo of EPIZYME or its Affiliates on such materials;
(ii) EISAI shall solely bear all costs and expenses incurred in connection with
exercising its rights under such license; and (iii) EISAI shall be solely
responsible for the compliance of all such promotional materials and their use
by or on behalf of EISAI with Laws in the EISAI Territory.

5.2 License Grants to EPIZYME. Subject to the terms and conditions of this
Agreement:

5.2.1 Licensed Compounds and Licensed Products. EISAI hereby grants to EPIZYME
(a) an exclusive right and license (even as to EISAI and its Affiliates), with
the right to grant sublicenses (subject to Section 5.2.2), under the EISAI IP,
the EISAI Collaboration IP and EISAI’s interest in the Joint IP, to obtain and
maintain Regulatory Approvals for, use, offer for sale, sell, import and
otherwise Commercialize (but excluding Manufacturing) Licensed Compounds and
Licensed Products in the Field in the EPIZYME Territory, (b) a non-exclusive
right and license, with the right to grant sublicenses (subject to
Section 5.2.2), under the EISAI IP, the EISAI Collaboration IP and EISAI’s
interest in the Joint IP, to conduct and have conducted global Development
activities and to Manufacture and have Manufactured Licensed Compounds and
Licensed Products anywhere in the world solely for purposes of exercising the

 

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rights and licenses granted in the foregoing clause (a), and (c) a non-exclusive
right and license, with the right to grant sublicenses (subject to
Section 5.2.2), under the EISAI IP, the EISAI Collaboration IP and EISAI’s
interest in the Joint IP, to Manufacture and have Manufactured Licensed
Compounds and Licensed Products anywhere in the world solely for the supply
thereof to EISAI in the EISAI Territory as set forth in Section 3.3.

5.2.2 EPIZYME’s Sublicensing Rights. EPIZYME may grant sublicenses under the
rights granted to it under Section 5.2.1 to (a) any of EPIZYME’s Affiliates and
to any Third Party in any country other than a country in Asia without the prior
written consent of EISAI, or (b) subject to compliance with Section 5.6, any of
EPIZYME’s Affiliates and to any Third Party in Asia (outside of the EISAI
Territory) without the prior written consent of EISAI. EPIZYME shall provide
EISAI with a fully-executed copy of any agreement (redacted as necessary to
protect confidential or commercially sensitive information) reflecting any
sublicense granted by EPIZYME under this Section 5.2.2, other than sublicenses
to Affiliates or Third Party service providers engaged by EPIZYME in the
ordinary course of business, promptly (but in no event later than [**] days)
after the execution thereof. Each sublicense granted by EPIZYME under this
Section 5.2.2 shall be subject to and consistent with the terms and conditions
of this Agreement. EPIZYME shall remain primarily liable for, and shall
guarantee the performance of, its Affiliates and Sublicensees with respect to
any sublicense granted pursuant to this Section 5.2.2.

5.3 Rights Retained by the Parties.

5.3.1 Any rights of EPIZYME or EISAI, as the case may be, not expressly granted
to the other Party pursuant to this Agreement shall be retained by such Party.

5.3.2 For clarity, subject to Section 7.1 and Section 7.2:

(a) EPIZYME retains the right, under Patents and Know-How Controlled by EPIZYME,
including its interest in Joint IP, to perform ongoing platform discovery
activities;

(b) EPIZYME retains the right, under Patents and Know-How Controlled by EPIZYME,
including its interest in Joint IP, to Develop, Manufacture and Commercialize
biomarkers and diagnostic assays and tests outside of this Agreement, subject to
the license granted to EISAI under Section 5.1.1; and

(c) EISAI retains the right, under Patents and Know-How Controlled by EISAI,
including its interest in Joint IP, to Develop, Manufacture and Commercialize
biomarkers and diagnostic assays and tests outside of this Agreement, subject to
the license granted to EPIZYME under Section 5.2.1.

5.4 Section 365(n) of the Bankruptcy Code. All rights and licenses granted under
or pursuant to this Agreement by EISAI or EPIZYME are, and shall otherwise be
deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code or any
analogous provisions in any other country or jurisdiction, licenses of right to
“intellectual property” as defined under Section 101 of the U.S. Bankruptcy
Code. The Parties agree that the Parties, as licensees of such rights under this
Agreement, shall retain and may fully exercise all of their respective rights
and

 

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elections under the U.S. Bankruptcy Code or any analogous provisions in any
other country or jurisdiction. The Parties further agree that, in the event of
the commencement of a bankruptcy proceeding by or against either Party under the
U.S. Bankruptcy Code or any analogous provisions in any other country or
jurisdiction, the Party hereto that is not a party to such proceeding shall be
entitled to a complete duplicate of (or complete access to, as appropriate) any
such intellectual property and all embodiments of such intellectual property,
which, if not already in the non-subject Party’s possession, shall be promptly
delivered to it (a) upon any such commencement of a bankruptcy proceeding upon
the non-subject Party’s written request therefor, unless the Party subject to
such proceeding elects to continue to perform all of its obligations under this
Agreement, or (b) if not delivered under clause (a) above, following the
rejection of this Agreement by or on behalf of the Party subject to such
proceeding upon written request therefor by the non-subject Party.

5.5 Access to Know-How.

5.5.1 To the extent not already provided prior to the Restatement Date, each
Party promptly shall provide to the other Party access to, and copies of all
documents and materials containing, the Know-How and Collaboration Know-How
licensed to the other Party hereunder as shall be reasonably requested by the
other Party as necessary or reasonably useful to exercise its rights under the
license grants in Sections 5.1.1 and 5.2.1 in order to exercise such license
rights.

5.5.2 In furtherance of, and subject to, the foregoing and without expanding the
scope of the licenses granted pursuant to Sections 5.1.1 and 5.2.1, from time to
time, each Party shall:

(a) make reasonably available to the other Party then existing documentation
Controlled by the providing Party constituting material support, performance
advice, shop practice, standard operating procedures, specifications as to
materials to be used and control methods that are necessary or reasonably useful
to use and practice the Know-How and Patents licensed hereunder; and

(b) cause appropriate employees and representatives of such Party and its
Affiliates to meet with employees or representatives of the other Party, at
mutually convenient times, to provide reasonable technical assistance to the
other Party with respect to the use and practice of the Know-How and Patents
licensed hereunder.

5.6 Right of Negotiation. In the event that EPIZYME or any Affiliate desires to
grant to a Third Party rights to Develop or Commercialize (including rights to
distribute) any Licensed Compound or Licensed Product in any country in Asia,
then EPIZYME shall provide EISAI with written notice (a “Third Party Offer
Notice”) that EPIZYME is soliciting offers from Third Parties for such rights.
EPIZYME shall not enter into any agreement with respect to such rights with any
Third Party until thirty (30) days (or such longer period as the Parties may
agree) after delivery of the Third Party Offer Notice to EISAI. If, within such
thirty (30) day (or such longer period as the Parties may agree) period, EISAI
delivers to EPIZYME a written offer proposing financial and other terms for the
expansion of this Agreement to include such rights, then EPIZYME shall negotiate
such offer with EISAI exclusively and in good faith for a period of

 

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ninety (90) days (or such longer period as the Parties may agree) (the
“Negotiating Period”) and EPIZYME shall not discuss or enter into any agreement
with respect to such rights with any Third Party during the Negotiating Period.
If the Parties do not reach a written agreement for the expansion of rights
under this Agreement during the Negotiating Period, then EPIZYME and its
Affiliates thereafter shall be free to enter into an agreement with a Third
Party with respect to such rights on such terms as EPIZYME may determine in its
sole discretion. If EISAI fails to provide EPIZYME with a written offer
proposing financial and other terms for the expansion of this Agreement to
include such rights during the applicable thirty (30) day (or such longer period
as the Parties may agree), then EPIZYME and its Affiliates shall be free to
enter into an agreement with a Third Party with respect to such rights on such
terms as EPIZYME may determine in its sole discretion.

ARTICLE 6

FINANCIAL TERMS

6.1 Execution Payment. Within ten (10) Business Days after the Restatement Date
EPIZYME shall pay EISAI a non-refundable, non-creditable payment of Forty
Million Dollars ($40,000,000).

6.2 Development Costs. From and after the Restatement Date, except as is
otherwise expressly set forth herein, each Party shall be solely responsible for
any and all Development Costs incurred by such Party or its Affiliates, and any
and all internal costs of such Party or its Affiliates, in performing activities
in connection with the Development of Licensed Compounds and Licensed Products
hereunder.

6.3 Development Milestones.

6.3.1 In partial consideration for the amendment and restatement of the Prior
Agreement and the rights and licenses granted to EPIZYME hereunder, EPIZYME
shall make the non-creditable milestone payments to EISAI that are set forth
below in accordance with Section 6.3.2 upon the first occurrence of the
milestone events set forth below.

 

Milestone Event

   Milestone
Payments  

(1) The earlier to occur of (a) Initiation by or on behalf of EPIZYME, its
Affiliates or Sublicensees of a first Phase 3 Clinical Trial of any Licensed
Product for any Indication and in any specific patient population, and (b) the
first submission by or on behalf of EPIZYME, its Affiliates or Sublicensees in
the United States or a Major EU Country (or to the EMA through the centralized
approval procedure) of an NDA for any Licensed Product for any Indication and in
any specific patient population.

     [**]   

 

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Milestone Event

   Milestone
Payments  

(2) The earlier to occur of (a) Initiation by or on behalf of EPIZYME, its
Affiliates or Sublicensees of a first Phase 3 Clinical Trial for any Licensed
Product either (i) for an Indication different from the Indication for which a
previous Phase 3 Clinical Trial for any Licensed Product has been Initiated or
an NDA for any Licensed Product previously has been submitted in the United
States or a Major EU Country (or to the EMA through the centralized approval
procedure), or (ii) for the same the Indication for which a previous Phase 3
Clinical Trial for any Licensed Product has been Initiated or for which an NDA
for any Licensed Product previously has been submitted in the United States or a
Major EU Country (or to the EMA through the centralized approval procedure), but
in a different specific patient population from the specific patient population
for which a previous Phase 3 Clinical Trial for any Licensed Product for such
Indication has been Initiated or for which an NDA for any Licensed Product
previously has been submitted in the United States or a Major EU Country (or to
the EMA through the centralized approval procedure), and (b) the first
submission by or on behalf of EPIZYME, its Affiliates or Sublicensees in the
United States or a Major EU Country (or to the EMA through the centralized
approval procedure) of an NDA for any Licensed Product either (i) for an
Indication different from the Indication for which a previous Phase 3 Clinical
Trial for any Licensed Product has been Initiated or for which an NDA for any
Licensed Product previously has been submitted in the United States or a Major
EU Country (or to the EMA through the centralized approval procedure), or (ii)
for the same the Indication for which a previous Phase 3 Clinical Trial for any
Licensed Product has been Initiated or for which an NDA for any Licensed Product
previously has been submitted in the United States or a Major EU Country (or to
the EMA through the centralized approval procedure), but in a different specific
patient population from the specific patient population for which a previous
Phase 3 Clinical Trial for any Licensed Product for such Indication has been
Initiated or for which an NDA for any Licensed Product previously has been
submitted in the United States or a Major EU Country (or to the EMA through the
centralized approval procedure).

     [**]   

(3) First Regulatory Approval of any Licensed Product in the United States or a
Major EU Country (or by EMA through the centralized approval procedure) for any
Indication and in any specific patient population.

     [**]   

 

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Milestone Event

   Milestone
Payments  

(4) First Regulatory Approval of any Licensed Product in the United States or a
Major EU Country (or by EMA through the centralized approval procedure) (a) for
an Indication different from the Indication for which a previous Regulatory
Approval for any Licensed Product has been obtained or (b) for the same the
Indication for which a previous Regulatory Approval for any Licensed Product has
been obtained, but in a different specific patient population from the specific
patient population for which a previous Regulatory Approval for any Licensed
Product has been obtained.

     [**]   

No milestone payment in this Section 6.3.1 will be made more than once
irrespective of the number of Licensed Products that have achieved the milestone
events set forth in this Section 6.3.1. The maximum aggregate amount payable by
EPIZYME pursuant to this Section 6.3.1 is $70,000,000.

6.3.2 Upon achievement by or on behalf of EPIZYME, its Affiliates or
Sublicensees of any milestone event listed above, EPIZYME shall promptly (but in
no event more than ten (10) Business Days after achievement thereof) notify
EISAI of such achievement, and EPIZYME shall pay EISAI the corresponding
milestone payment within thirty (30) days after receipt of an invoice for the
milestone payment from EISAI (which invoice shall not be sent by EISAI prior to
achievement of such milestone event).

6.4 Licensed Product Royalties.

6.4.1 Royalties.

(a) EISAI Territory Royalties. In partial consideration for the amendment and
restatement of the Prior Agreement and the rights and licenses granted to EISAI
hereunder, subject to Sections 6.4.2, 6.4.3, and 6.4.4, EISAI shall pay EPIZYME
royalties of [**]% of Net Sales of each Therapeutic Product in the EISAI
Territory during the Royalty Term for such Therapeutic Product, on a Therapeutic
Product-by-Therapeutic Product basis.

(b) EPIZYME Territory Royalties. In partial consideration for the amendment and
restatement of the Prior Agreement and the rights and licenses granted to
EPIZYME hereunder, subject to Sections 6.4.2, 6.4.3, and 6.4.4, EPIZYME shall
pay EISAI royalties of [**]% of Net Sales of each Therapeutic Product in each
country in the EPIZYME Territory during the Royalty Term for such Therapeutic
Product in such country, on a Therapeutic Product-by-Therapeutic Product basis.

6.4.2 Royalty Term and Adjustments.

(a) Each Party’s royalty obligations under Section 6.4.1 shall commence on a
country-by-country and Licensed Product-by-Licensed Product basis on the date of
First Commercial Sale by such Party, its Affiliates or Sublicensees of the
relevant Licensed Product in the relevant country and shall expire on a
country-by-country basis and Licensed Product-by-Licensed Product basis upon the
latest of the following (the “Royalty Term”), as applicable:

(i) expiration of Patent-Based Exclusivity with respect to such Licensed Product
in such country;

 

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(ii) expiration of Regulatory-Based Exclusivity with respect to such Licensed
Product in such country; and

(iii) the tenth (10th) anniversary of the First Commercial Sale of such Licensed
Product in such country by such Party, its Affiliates or Sublicensees.

(b) The foregoing provisions of this Section 6.4 notwithstanding, the royalties
payable with respect to Net Sales of Licensed Products shall be reduced, on a
Licensed Product-by-Licensed Product and country-by-country basis, to [**]
percent ([**]%) of the amounts otherwise payable pursuant to Section 6.4.1
during any portion of the Royalty Term when neither Patent-Based Exclusivity nor
Regulatory-Based Exclusivity applies to such Licensed Product in such country.

(c) Each Party shall have no obligation to pay any royalty with respect to Net
Sales of any Licensed Product in any country after the Royalty Term for such
Licensed Product in such country has expired.

6.4.3 Royalty Reduction for Comparable Third Party Product Competition. If, on a
Licensed Product-by-Licensed Product, country-by-country and Calendar
Quarter-by-Calendar Quarter basis, (a) Comparable Third Party Product
Competition is present with respect to such Licensed Product in such country
during such Calendar Quarter, or (b) a court or a governmental agency of
competent jurisdiction requires the Applicable Commercialization Party or any of
its Affiliates or Sublicensees to grant a compulsory license to a Third Party
permitting such Third Party to make and sell such Licensed Product in such
country (such Licensed Product when sold by such Third Party, a “Compulsory
Third Party Product”), and such Compulsory Third Party Product(s) have a market
share of [**] percent ([**]%) or more of the aggregate market in such country of
the applicable Licensed Product and the Compulsory Third Party Product(s)
collectively (based on sales of units of such Licensed Product and such
Compulsory Third Party Product(s), as reported by IMS International, or if such
data are not available, such other reliable data source as reasonably determined
by EPIZYME and EISAI (as used herein, a “unit” of a product means the equivalent
amount of product used for an equivalent treatment cycle of such product)),
then, in each case (clause (a) or (b)), the royalties payable with respect to
Net Sales of such Licensed Product pursuant to Sections 6.4.1 and 6.4.2 in such
country during such Calendar Quarter shall be reduced to [**] percent ([**]%) of
the royalties otherwise payable pursuant to Sections 6.4.1 and 6.4.2.

6.4.4 Third Party Payments.

(a) Subject to Section 6.4.4(c), the Applicable Commercialization Party shall be
entitled to credit against the royalties due to the other Party on Net Sales of
a Licensed Product in a country an amount equal to [**] percent ([**]%) of all
upfront payments, milestone payments, royalties, and other amounts paid by the
Applicable Commercialization Party, its Affiliates or Sublicensees to Third
Parties with respect to license rights to Third Party intellectual property
licensed by the Applicable Commercialization Party, its Affiliates or
Sublicensees from

 

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the applicable Third Party that the Applicable Commercialization Party
reasonably believes are necessary for the Development, Manufacture, or
Commercialization of such Licensed Product in such country; provided, however,
that, to the extent that any such Third Party license includes a license to
Third Party intellectual property that is applicable to products being or to be
developed or commercialized by the Applicable Commercialization Party or its
Affiliates other than such Licensed Product in such country, then the Applicable
Commercialization Party shall reasonably allocate all upfront payments,
milestone payments and other non-royalty amounts between the Licensed Product
and such other products, and the Applicable Commercialization Party shall only
be entitled to credit against the royalties due to the other Party hereunder on
Net Sales of such Licensed Product [**] percent ([**]%) of the amounts that are
reasonably allocable to the Licensed Product. In addition, the Applicable
Commercialization Party shall be entitled to credit against the royalties due to
the other Party hereunder defense costs in accordance with Section 8.4.

(b) In the event a Party enters into any Third Party intellectual property
license necessary for the Development, Manufacture, or Commercialization of a
Licensed Product in a country in the other Party’s part of the Territory after
the Restatement Date (EPIZYME represents and warrants to EISAI that EPIZYME is
not a party to any such relevant Third Party licenses as of the Restatement
Date), under which such Party is entitled to grant a sublicense to the other
Party, the other Party will have the right to obtain such sublicense from such
sublicensor Party; provided that, if such other Party elects to obtain such
sublicense, such other Party shall pay [**] percent ([**]%) of the amounts
payable to the Third Party on account of such sublicense (either directly to the
Third Party licensor or to the sublicensor Party, as the Parties shall
reasonably agree with the goal of ensuring timely payment to the Third Party)
and such other Party shall be entitled to credit against the royalties due to
the sublicensor Party on Net Sales of such Licensed Product in such country in
an amount equal to [**] percent ([**]%) of the amounts paid by such other Party
(either directly or indirectly through the sublicensor Party) to such Third
Party with respect to such license rights for such Licensed Product in such
country.

(c) If any amount is or becomes payable to UNC under the UNC License Agreement
(or under any other agreement entered into by EPIZYME or any Affiliate and UNC
with respect to the intellectual property that is the subject of the UNC License
Agreement) with respect to the Development, Manufacture, or Commercialization of
a Licensed Product in any country in the world, EPIZYME shall be solely
responsible for and shall pay all such amounts, and no such amounts shall be
creditable against any royalties payable to EISAI hereunder.

6.4.5 Aggregate Limitation on Deductions. Notwithstanding anything to the
contrary herein, under no circumstances shall the combined effect of all
reductions to the royalties payable to a Party under Sections 6.4.2(b), 6.4.3
and 6.4.4, on a country-by-country and Licensed Product-by-Licensed Product
basis, reduce the effective royalties payable by a Party pursuant to this
Agreement for any Calendar Quarter below [**] percent ([**]%) of the otherwise
applicable royalties pursuant to Section 6.4.1; provided that, each Party shall
have the right to carry forward for application against royalties payable to the
other Party with respect to Net Sales of such Licensed Product in such country
in future periods any amount that is not so credited due to the limitation in
this Section 6.4.5.

 

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6.5 Blended Royalty. Each Party acknowledges that (a) the licensed Know-How and
the Know-How included in the Regulatory Materials Controlled by the other Party
are proprietary and valuable and that without such Know-How and Regulatory
Materials such Party would not be able to obtain and maintain Regulatory
Approvals with respect to the Licensed Products in such Party’s part of the
Territory, (b) such Regulatory Approvals may allow such Party to obtain and
maintain Regulatory-Based Exclusivity with respect to the Licensed Products,
(c) access to the other Party’s Know-How and the rights with respect to the
Regulatory Materials have provided such Party with a competitive advantage in
the marketplace, and (d) the milestone payments and royalties set forth in
Sections 6.3, 6.4.1 and 6.4.2(b), respectively, are, in part, intended to
compensate the other Party for such exclusivity and such competitive advantage.
The Parties agree that the royalty rates set forth in Sections 6.4.1 and
6.4.2(b) reflect an efficient and reasonable blended allocation of the value
provided to such Party by the other Party.

6.6 Reports; Royalty Payments.

6.6.1 Until the expiration of each Party’s royalty payment obligations under
this Article 6, such Party shall make written reports to the other Party within
forty-five (45) days after the end of each Calendar Quarter covering sales of
Licensed Products on a product-by-product and country-by-country basis in the
applicable part of the Territory by such Party, its Affiliates and Sublicensees
during such Calendar Quarter. The information contained in each report under
this Section 6.6 shall be considered Confidential Information of the reporting
Party.

6.6.2 Each such written report shall provide Net Sales by country by Licensed
Product for the period in question, and all adjustments (if any) made pursuant
to Sections 6.4.2, 6.4.3 and 6.4.4. In addition to the foregoing, each such
written report shall, with respect to each of the Major Market Countries, and,
to the extent such information is available, with respect to other countries,
provide:

(a) number of units sold for each Licensed Product, as applicable;

(b) the gross sales for each Licensed Product, as applicable;

(c) a calculation of the adjustments to Net Sales for Combination Products (if
applicable); and

(d) the calculation of the royalty payment due on such Net Sales pursuant to
this Article 6.

6.6.3 Concurrently with the delivery of each such report, the reporting Party
shall make the royalty payment due to the other Party under this Article 6 for
the Calendar Quarter covered by such report.

6.7 Methods of Payments. All payments due from one Party (the “Payor”) to the
other Party (the “Payee”) under this Agreement shall be paid in Dollars by
electronic funds transfer to a bank account designated in writing by the Payee.

 

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6.8 Accounting.

6.8.1 Each Party agrees to keep, and to require its Affiliates and Sublicensees
to keep, full, clear and accurate records for a minimum period of three (3)
years after the relevant payment is owed pursuant to this Agreement setting
forth the sales and other disposition of Licensed Products sold or otherwise
disposed of and, to the extent EPIZYME is acting as a supplier to EISAI as
contemplated under Sections 3.3.1, 3.3.3 and 3.3.4, Cost of Goods, in sufficient
detail to enable royalties and other amounts payable to the other Party under
this Agreement to be determined.

6.8.2 Each Party (the “audited Party”) further agrees, upon not less than thirty
(30) days’ prior written notice, to permit, and to require its Affiliates and
Sublicensees to permit, the books and records relating to sales of Licensed
Products and, if applicable, Cost of Goods, to be examined by an independent
accounting firm selected by the other Party (the “auditing Party”) and
reasonably acceptable to the audited Party, for the purpose of verifying reports
provided by the audited Party under Section 6.6 and, if applicable, Cost of
Goods. Such audit shall not (i) be performed more frequently than once in any
twelve (12)-month period (unless a previous audit during such twelve (12)-month
period revealed a material discrepancy with respect to such period), (ii) be
conducted for any Calendar Quarter more than three (3) years after the end of
the Calendar Year of which such Calendar Quarter is a part, or (iii) be repeated
for any Calendar Quarter, and shall be conducted under appropriate
confidentiality provisions, for the sole purpose of verifying the accuracy and
completeness of all reports provided under Section 6.6 and, if applicable, Cost
of Goods. The independent accounting firm shall have the right to make copies of
relevant portions of the audited Party’s books and records; provided that any
such copies shall be the Confidential Information of the audited Party, shall be
protected by appropriate confidentiality obligations and shall not be shared
with the auditing Party or any other Person. The independent accounting firm
will prepare and provide to EISAI and EPIZYME a written report stating only
whether the reports submitted and amounts paid hereunder were correct or
incorrect, and the amounts of any discrepancies.

6.8.3 Such examination is to be made at the expense of the auditing Party,
except if the results of the audit reveal an underpayment of royalties to the
auditing Party by the audited Party of [**] percent ([**]%) or more in any
Calendar Year, or an overpayment by EISAI to EPIZYME for Licensed Compound or
Licensed Product supplied by EPIZYME pursuant to Section 3.3 of [**] percent
([**]%) or more in any Calendar Year, in which case reasonable audit fees for
such examination shall be paid by the audited Party.

6.8.4 When calculating Net Sales, the amount of such sales in foreign currencies
shall be converted into Dollars using the standard methodologies employed by the
audited Party for consolidation purposes. The audited Party shall provide
reasonable documentation of the calculation and reconciliation of the conversion
figures on a product-by-product and country-by-country basis as part of its
report of Net Sales for the period covered under the applicable report.

6.8.5 EPIZYME shall keep, and shall require its Affiliates to keep, full, clear
and accurate records of all Development Costs incurred by EPIZYME and its
Affiliates in performing activities in connection with the Development of
Licensed Compounds and Licensed Products hereunder, which records shall be
subject to audit to the extent set forth in Section 12.5.2(h)(iii).

 

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6.9 Withholding Taxes. The Payor shall inform the Payee of any withholding tax
obligation imposed by taxing authorities on payments due to the Payee under this
Agreement as soon as it becomes aware of the withholding tax obligation. The
Parties shall meet promptly thereafter to discuss how best to minimize the
amount of such withholding tax obligation, and the Payee shall take all
reasonable and lawful steps requested by the Payor to minimize the amount of any
such withholding tax obligation at the Payor’s expense. The Parties agree to
cooperate in good faith to provide one another with such documents and
certifications as are reasonably necessary to enable EISAI and EPIZYME to
minimize or recover any withholding tax payment. EISAI may withhold taxes in the
event that revenue authorities in any country outside the United States require
the withholding of taxes on amounts paid hereunder to EPIZYME, and EPIZYME may
withhold taxes in the event that revenue authorities in any country outside
Japan require the withholding of taxes on amounts paid hereunder to EISAI. In
any such event the Payor shall deduct such taxes from such payment and such
taxes shall be paid by the Payor to the proper taxing authority on behalf of the
Payee (evidence of which payment to such taxing authority shall be provided
promptly by the Payor to the Payee hereunder). Notwithstanding the foregoing
provisions of this Section 6.9, if EISAI is required by any taxing authority
outside of the United States to withhold taxes from any amount payable by EISAI
hereunder, or if EPIZYME is required by any taxing authority outside of Japan to
withhold taxes from any amount payable by EPIZYME hereunder, then the Payor
shall pay to the Payee an additional amount as may be necessary so that the
Payee shall receive, after deduction of such withholding tax, the amount which
the Payee would have received in the absence of such withholding tax; provided
that, such payment of additional amounts shall not be required to the extent the
required withholding of taxes results from the Payee’s assignment of this
Agreement or redomiciliation of the Payee outside of Japan, in the case of
EISAI, or outside of the United States, in the case of EPIZYME.

6.10 Late Payments. Any undisputed amount owed by Payor to Payee under this
Agreement that is not paid on or before the date such payment is due shall bear
interest at a rate per annum equal to the lesser of (a) the prime or equivalent
rate per annum quoted by The Wall Street Journal, Eastern Edition on the first
Business Day after such payment is due, plus [**] basis points, and (b) the
highest rate permitted by applicable Law, in either case calculated on the
number of days such payments are paid after such payments are due and compounded
monthly. Interest shall not accrue on undisputed amounts that were paid after
the due date as a result of mistaken Payee actions (e.g., if a payment is late
as a result of Payee providing an incorrect account for receipt of payment).

6.11 Limitations on Payments for [**] Use. Notwithstanding anything herein to
the contrary, except as otherwise set forth in the last sentence of this
Section 6.11, the royalties in Section 6.4.1 shall not apply to [**], provided,
that neither Party may sell any [**] unless and until the Parties have mutually
agreed upon the royalties payable on Net Sales of such [**], as applicable, in
accordance with this Section 6.11, or a Party elects, in its sole discretion and
by written notice to the other Party, to sell such [**], as applicable, subject
to payment of the royalties set forth in Section 6.4.1 with respect to such
[**], as applicable. In the event that a Party Develops a [**], the Parties
shall negotiate a downward adjustment to the royalties set forth in
Section 6.4.1 for the sale of such [**] that reflects the commercial potential
of such product and standard commercial terms in the industry for [**], as
applicable (it being understood that either Party may elect, in its sole
discretion and upon written notice to the other Party, to sell such [**], as
applicable, subject to payment of the royalties set forth in Section 6.4.1 with
respect to such [**], as applicable).

 

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6.12 FDA Priority Review Voucher.

6.12.1 If EPIZYME, its Affiliate or Sublicensee is awarded a PRV in connection
with the NDA for any Licensed Product, and EPIZYME, such Affiliate or
Sublicensee thereafter sells such PRV to a Third Party, EPIZYME shall pay to
EISAI [**] percent ([**]%) of the total consideration that EPIZYME, such
Affiliate or Sublicensee receives for such sale within ten (10) Business Days
after receipt of such consideration. EPIZYME shall notify EISAI of the execution
by EPIZYME, its Affiliate or Sublicensee of any agreement for the sale of such
PRV to a Third Party and shall provide to EISAI a complete copy of such sale
agreement within ten (10) Business Days after such execution. In case any such
consideration received by EPIZYME, such Affiliate or Sublicensee is non-cash
consideration, the value of such non-cash consideration shall be determined in
good faith by the Parties.

6.12.2 If EPIZYME, its Affiliate or Sublicensee is awarded a PRV in connection
with the NDA for any Licensed Product, and EPIZYME, such Affiliate or
Sublicensee thereafter redeems such PRV for use with any product other than a
Licensed Product, then (a) not later than ten (10) Business Days after the date
of such redemption (the “Redemption Date”) EPIZYME shall notify EISAI of such
redemption, and (b) not later than [**] days after the Redemption Date, pay to
EISAI an amount equal to [**] percent ([**]%) of the mean of the sales prices of
the [**] PRVs most recently sold by Third Parties prior to the Redemption Date.
For the avoidance of doubt, no compensation shall be payable by EPIZYME to EISAI
under this Section 6.12.2 if EPIZYME, its Affiliate or Sublicensee redeems a PRV
for use with a Licensed Product.

6.12.3 If the Parties are unable to reach agreement as to a valuation pursuant
to Section 6.12.1 or 6.12.2, the Parties will refer such matter to a jointly
selected Third Party with expertise in the pricing of pharmaceutical products
that is not an employee, consultant, legal advisor, officer, director or
stockholder of, and does not have any conflict of interest with respect to,
either Party for resolution. If the Parties are unable to agree on such a Third
Party expert within thirty (30) days after a Party has notified the other Party
that it desires to refer such matter to such a Third Party for resolution,
either Party may request that the New York, New York office of the AAA appoint
such an expert to resolve such matter. The resolution determined by any such
expert that is either jointly selected or appointed by the AAA shall be final
and binding on the Parties.

ARTICLE 7

EXCLUSIVITY; CHANGE OF CONTROL

7.1 Target Exclusivity. Except for Licensed Compounds and Licensed Products
pursuant to this Agreement, until the expiration of the Target Exclusivity
Period, neither Party nor any of its respective Affiliates shall, except as
otherwise permitted in Section 7.2, either (a) alone or with or for any Third
Party, Develop, Manufacture (for Development or Commercialization), or
Commercialize in the Field any Compounds directed to EZH2 anywhere in the
Territory, or (b) grant a license or sublicense to, sell or transfer assets
(including intellectual property) to, or otherwise assist or contract with, any
Third Party to Develop, Manufacture (for Development or Commercialization), or
Commercialize in the Field any Compounds directed to EZH2 anywhere in the
Territory.

 

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7.2 Exceptions. Notwithstanding the foregoing:

7.2.1 If a Change of Control Event occurs with respect to EPIZYME, and the
Person that acquires, combines with or comes to control EPIZYME or acquires
EPIZYME’s assets as a result of such Change of Control Event (or any of such
Person’s then-existing Affiliates) already has a program or business that
existed prior to the Change of Control Event that would otherwise violate
Section 7.1 above at the time of such Change of Control Event (such program or
business, to the extent that the conduct thereof would otherwise violate
Section 7.1, a “Competing Business”), such Person (or such Person’s Affiliate)
shall be permitted to continue such Competing Business after such Change of
Control Event and such continuation shall not constitute a violation of
Section 7.1 above, provided that:

(a) the Development activities of EPIZYME under this Agreement shall be
conducted separately (including by separate personnel) from any Development
activities of EPIZYME directed to such Competing Business, including the
maintenance of separate lab notebooks and records; and

(b) EPIZYME shall continue to comply with all of its obligations hereunder,
including its obligations under Section 3.2.1.

7.2.2 If either Party or any of its Affiliates merges or consolidates (in a
transaction that does not constitute a Change of Control Event) with, or
acquires, a Third Party with a Competing Business, or if either Party or any of
its Affiliates acquires assets that include a Competing Business, in any case
pursuant to a transaction or series of transactions in which the acquisition of
the Competing Business is ancillary to and not a principal focus of the
transaction or series of transactions, then such continuing operation of the
Competing Business for up to [**] months following the closing of such
transaction or the first of any series of transactions shall not constitute a
breach of Section 7.1, if the Party within [**] months after the closing date of
such transaction or the first of any series of transactions either divests, or
causes the relevant Affiliate to divest, the Competing Business, or permanently
ceases, or causes the relevant Affiliate to permanently cease, operations of the
Competing Business; provided that, in no event shall either Party or any of its
Affiliates be permitted to merge or consolidate with, or acquire, a Third Party
that is in a Competing Business, or acquire assets that include a Competing
Business, pursuant to a transaction or series of transactions in which the
acquisition of the Competing Business is the principal focus of the transaction
or series of transactions.

ARTICLE 8

INTELLECTUAL PROPERTY RIGHTS

8.1 Ownership.

8.1.1 Intellectual Property Arising Outside of this Agreement. As between the
Parties, EPIZYME shall retain all of its right, title and interest in, to and
under the EPIZYME IP and EISAI shall retain all of its rights, title and
interest in, to and under the EISAI IP, except to the extent that any such
rights are expressly licensed by one Party to the other Party under this
Agreement.

 

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8.1.2 Intellectual Property Arising Under This Agreement.

(a) EISAI shall be the sole owner of any EISAI Collaboration Know-How and EISAI
Collaboration Patents, and EISAI shall retain all of its right, title and
interest thereto, except to the extent that any rights or licenses are expressly
granted thereunder by EISAI to EPIZYME under this Agreement.

(b) EPIZYME shall be the sole owner of any EPIZYME Collaboration Know-How and
EPIZYME Collaboration Patents, and EPIZYME shall retain all of its right, title
and interest thereto, except to the extent that any rights or licenses are
expressly granted thereunder by EPIZYME to EISAI under this Agreement.

(c) Any Joint Patents or Joint Know-How shall be owned jointly by EISAI and
EPIZYME, and all rights, title and interest thereto shall be jointly owned by
the Parties, subject to any rights or licenses that are expressly granted by one
Party to the other Party under this Agreement. Except to the extent either Party
is restricted by the licenses granted by one Party to the other Party pursuant
to this Agreement, or the covenants contained herein, each Party shall be
entitled to practice and license the Joint Know-How and the Joint Patents
without restriction and without consent of, or (subject to the financial
provisions of this Agreement) an obligation to account to, the other Party, and
each Party hereby waives any right it may have under Laws to require any such
consent or accounting.

8.2 Prosecution and Maintenance of Patents.

8.2.1 EPIZYME Patents; Collaboration Patents; Joint Patents. Subject to
Section 8.2.2:

(a) As between the Parties, EPIZYME shall have the right (but not the
obligation) to Prosecute and Maintain the EPIZYME Patents, Collaboration
Patents, and Joint Patents. EPIZYME shall keep EISAI informed as to material
developments with respect to the Prosecution and Maintenance of such Patents,
including by providing copies of all substantive office actions or any other
substantive documents that EPIZYME receives from any patent office, including
notice of all interferences, reissues, re-examinations, oppositions or requests
for patent term extensions.

(b) EPIZYME shall also provide EISAI with a reasonable opportunity to
substantively comment on Prosecution and Maintenance of EPIZYME Patents,
Collaboration Patents, and Joint Patents prior to taking material actions
(including the filing of initial applications), and will in good faith consider
any actions recommended by EISAI. EISAI shall have the right to review and make
comments on and recommendations in relation to the Prosecution and Maintenance
of such Patents; provided that EISAI does so promptly and consistent with any
applicable filing deadlines.

 

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8.2.2 Filing Decision or Prosecution Lapse. If, during the Term, the Party with
the first right, pursuant to Section 8.2.1, to Prosecute and Maintain an EPIZYME
Patent, Collaboration Patent or Joint Patent, as applicable, in any country
decides not to file such Patent or intends to allow such Patent to lapse or
become abandoned without having first filed a substitute, the prosecuting or
maintaining Party shall notify and consult with the other Party on such decision
or intention at least [**] days prior to the date upon which the subject matter
of such Patent shall become unpatentable or such Patent shall lapse or become
abandoned, and such other Party shall thereupon have the right (but not the
obligation) to assume the Prosecution and Maintenance thereof at its own expense
with counsel of its own choice.

8.2.3 Cooperation Regarding the Filing and Prosecution of Patents.

(a) The Parties agree to cooperate fully in the preparation, filing,
prosecution, and maintenance of the EPIZYME Patents that are primarily
applicable to EZH2 or EZH2 Compounds, Collaboration Patents, and Joint Patents
in the Territory under this Agreement. Cooperation shall include:

(i) executing all papers and instruments, or requiring its employees or
contractors to execute such papers and instruments, so as to (A) effectuate the
ownership of intellectual property set forth in Section 8.1, (B) enable the
other Party to apply for and to prosecute Patent applications in the Territory,
and (C) obtain and maintain any Patent extensions, supplementary protection
certificates, and the like with respect to the EPIZYME Patents that are
primarily applicable to EZH2 or EZH2 Compounds, Collaboration Patents, or Joint
Patents, each of (A), (B), and (C) to the extent provided for in this Agreement;

(ii) consistent with this Agreement, assisting in any license registration
processes with applicable governmental authorities that may be available in the
Territory for the protection of a Party’s interests in this Agreement; and

(iii) promptly informing the other Party of any matters coming to such Party’s
attention that may materially affect the preparation, filing, prosecution, or
maintenance of any EPIZYME Patents that are primarily applicable to EZH2 or EZH2
Compounds, Collaboration Patents, or Joint Patents in the Territory.

(b) At either Party’s request, the Parties shall cooperate with one another to
file and prosecute divisional Patent applications with respect to EPIZYME
Patents that are primarily applicable to EZH2 or EZH2 Compounds, Collaboration
Patents and Joint Patents for which either Party is responsible for Prosecution
and Maintenance pursuant to this Section 8.2, if practicable and if necessary or
desirable to divide subject matter relating to the Development, Manufacture or
Commercialization of Licensed Compounds and Licensed Products from other subject
matter.

8.2.4 United States Law. The determination of whether Know-How discovered,
developed, invented, conceived or reduced to practice made by a Party for the
purpose of allocating proprietary rights (including Patent or other intellectual
property rights) therein, shall, for purposes of this Agreement, be made in
accordance with Law in the United States as in effect on the Prior Agreement
Effective Date.

 

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8.2.5 CREATE Act. Notwithstanding anything to the contrary in this Article 8,
neither Party shall have the right to make an election under the Cooperative
Research and Technology Enhancement Act of 2004, 35 U.S.C. § 103(c)(2)-(c)(3)
(the “CREATE Act”) when exercising its rights under this Article 8 without the
prior written consent of the other Party. With respect to any such permitted
election, the Parties shall use reasonable efforts to cooperate and coordinate
their activities with respect to any submissions, filings or other activities in
support thereof. The Parties acknowledge and agree that this Agreement is a
“joint research agreement” as defined in the CREATE Act.

8.3 Patent Costs. Each Party shall be responsible for all costs and expenses
associated with its Prosecution and Maintenance activities under Section 8.2;
provided that, EISAI will reimburse EPIZYME for all EISAI Territory-specific
out-of-pocket costs and expenses reasonably incurred by EPIZYME for the
Prosecution and Maintenance of EPIZYME Patents, Collaboration Patents and Joint
Patents in the EISAI Territory pursuant to Section 8.2.1 within [**] days after
receipt of any invoice from EPIZYME therefor.

8.4 Defense of Claims Brought by Third Parties. If a Party becomes aware of any
claim, suit, or proceeding alleging that the Development, Manufacture or
Commercialization of a Licensed Compound or Licensed Product infringes the
intellectual property rights of any Third Party, such Party shall promptly
notify the other Party. Subject to Article 11, each Party shall have the first
right, but not the obligation, to defend and control the defense of any such
claim, suit, or proceeding brought against such Party at its own expense (but
subject to deduction as provided below), using counsel of its own choice. The
other Party may participate in any such claim, suit, or proceeding with counsel
of its choice at its own expense. Each Party shall keep the other Party
reasonably informed of all material developments in connection with any such
claim, suit, or proceeding. Each Party agrees to provide the other Party with
copies of all pleadings filed in such action and to allow the other Party
reasonable opportunity to participate in the defense of the claims. Each Party
shall be entitled to credit [**] percent ([**]%) of the reasonable out-of-pocket
costs of defending such claim, suit, or proceeding against royalties due to the
other Party pursuant to Section 6.4. Any recoveries by a Party of any sanctions
awarded to such Party and against a Third Party asserting a claim being defended
under this Section 8.4 shall be applied as follows: such recovery shall be
applied first to (i) reimburse such Party for its reasonable out-of-pocket costs
of defending such claim, suit or proceeding to the extent not credited against
royalties pursuant to the previous sentence, and (ii) reimburse the other Party
for royalty credits pursuant to the previous sentence, and to the extent the
amount of recovery is not sufficient to reimburse the Parties for the total
amount described under subsections (i) and (ii) above, the recovery shall be
shared by the Parties equally. The balance of any such recoveries shall be
retained by the Party defending such claim, suit or proceeding and included in
such Party’s Net Sales for the relevant Licensed Product.

8.5 Enforcement of EPIZYME Patents, Collaboration Patents and Joint Patents.

8.5.1 Duty to Notify of Infringement. If any Party learns of an infringement or
threatened infringement by a Third Party with respect to any EPIZYME Patent,
Collaboration Patent or Joint Patent, including actual or alleged infringement
under 35 U.S.C. § 271(e)(2), that is or would be competitive with a Licensed
Compound or Licensed Product (“Competitive Infringement”), such Party shall
promptly notify the other Party and shall provide such other Party with
available evidence of such Competitive Infringement.

 

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8.5.2 Enforcement of EPIZYME Patents. As between the Parties, EPIZYME shall have
the primary right, but not the obligation, to institute, prosecute, control and
settle any action or proceeding with respect to any Competitive Infringement of
EPIZYME Patents in the Territory, by counsel of its own choice, and EISAI shall
have the right, at its own expense, to be represented in such action by counsel
of its own choice. If EPIZYME fails to bring an action or proceeding or
otherwise take affirmative actions to address such infringement within a period
of [**] days after first being notified of such Competitive Infringement (or
[**] days after being notified in the case of an action brought under the
Hatch-Waxman Act or any ex-U.S. equivalent of the Hatch-Waxman Act), as between
the Parties, EISAI shall have the right to bring and control such an action by
counsel of its own choice, and EPIZYME shall have the right to be represented in
any such action by counsel of its own choice at its own expense.

8.5.3 Enforcement of Collaboration Patents and Joint Patents that Cover Licensed
Compounds. EPIZYME shall have the primary right, but not the obligation, to
institute, prosecute, control and settle any action or proceeding with respect
to any Competitive Infringement of Collaboration Patents and Joint Patents in
the Territory, by counsel of its own choice, and EISAI shall have the right, at
its own expense, to be represented in such action by counsel of its own choice.
If EPIZYME fails to bring an action or proceeding or otherwise take affirmative
actions to address such infringement within a period of [**] days after first
being notified of such Competitive Infringement (or [**] days after being
notified in the case of an action brought under the Hatch-Waxman Act or any
ex-U.S. equivalent of the Hatch-Waxman Act), EISAI shall have the right to bring
and control such an action by counsel of its own choice, and EPIZYME shall have
the right to be represented in any such action by counsel of its own choice at
its own expense.

8.5.4 Settlement. A settlement or consent judgment or other voluntary final
disposition of a suit under this Section 8.5 may be entered into without the
consent of the Party not bringing suit; provided that (a) any such settlement,
consent judgment or other disposition of any action or proceeding by a Party
under this Article 8 shall not, without the consent of the Party not bringing
suit, impose any liability or obligation on such Party not bringing suit,
(b) the Party bringing suit shall not settle, enter into a consent judgment or
dispose of any such claim, suit or proceeding, except in a manner that it
believes in good faith is in the best interests of the Licensed Products
(without taking into consideration products in such Party’s portfolio that are
not Licensed Products), (c) any such settlement, consent judgment or other
disposition of any action or proceeding by a Party under this Article 8 shall
not, without the consent of the Party not bringing suit, conflict with or reduce
the scope of the subject matter claimed in any Patent owned (solely or jointly)
by the Party not bringing suit, and (d) without the prior written consent of the
Party not bringing suit, the Party bringing suit shall not be entitled to grant
any license in the other Party’s part of the Territory that would conflict with
the licenses granted to the Party not bringing suit in Section 5.1 or
Section 5.2, as applicable.

8.5.5 Cooperation. If one Party brings any such action or proceeding in
accordance with this Section 8.5, the other Party agrees to be joined as a party
plaintiff where legally required to initiate or maintain suit or collect
damages, and to give the first Party reasonable assistance and authority to file
and prosecute the suit.

 

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8.5.6 Costs and Recoveries. The costs and expenses of the Party bringing suit
under this Section 8.5 shall be borne by such Party, and any damages or other
monetary awards recovered shall be shared as follows:

(a) the amount of such recovery actually received by the Party controlling such
action shall first be applied to the out-of-pocket costs incurred by each Party
in connection with such action; and

(b) then any remaining proceeds shall be allocated between the Parties such that
the Party bringing suit under this Section 8.5 retains [**] and the other Party
retains [**] of such amount.

8.5.7 Regulatory Data Protection. To the extent required by Law, EPIZYME shall
use Commercially Reasonable Efforts to promptly, accurately and completely list,
with the applicable Regulatory Authorities during the Term, all applicable
Patents for any Licensed Product that EPIZYME intends to, or has begun to,
Commercialize and that have become the subject of an application for Regulatory
Approval submitted to FDA, such listings to include all so called “Orange Book”
listings required under the Hatch-Waxman Act and all so called “Patent Register”
listings as required in Canada. Prior to such listings, the Parties shall meet
to evaluate and identify all applicable Patents. Notwithstanding the preceding
sentence, EPIZYME shall retain final decision-making authority as to the listing
of all applicable Patents for such Licensed Product, regardless of which Party
owns such Patent.

8.5.8 Patent Term Extensions. EPIZYME and EISAI shall discuss and seek to reach
mutual agreement for which, if any, of the Patents within the EPIZYME Patents,
Collaboration Patents, or Joint Patents the Parties shall apply to obtain patent
term extensions, adjustments, restorations, or supplementary protection
certificates under Law, based on the best commercial interests of the Licensed
Products Covered by such Patents. If the Parties are unable to reach mutual
agreement, as between the Parties, EPIZYME shall have the right to make the
final decision as to such Patents in the EPIZYME Territory and EISAI shall have
the right to make the final decision as to such Patents in the EISAI Territory.

8.6 Invalidity or Unenforceability Defenses or Actions.

8.6.1 Notice. If a Third Party asserts, as a defense or as a counterclaim in any
infringement action under Section 8.5 or claim or counterclaim asserted under
Section 8.4, or in a declaratory judgment action or similar action or claim
filed by such Third Party, in either case that any EPIZYME Patent, Collaboration
Patent or Joint Patent is invalid or unenforceable, then the Party pursuing such
infringement action, or the Party first obtaining knowledge of such assertion
shall promptly give written notice to the other Party.

8.6.2 Defense. The right to defend the applicable EPIZYME Patent, Collaboration
Patent or Joint Patent against such assertion of invalidity or unenforceability
shall be determined in the same manner as the right to enforce such Patent
pursuant to Section 8.5;

 

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provided that, if the assertion is made in a suit that is already being
controlled by a Party pursuant to Section 8.4 or 8.5, the controlling Party
shall retain control of such defense. The other Party may participate in any
such claim, suit, or proceeding with counsel of its choice at its own expense.
If a Party elects not to defend or control the defense of the EPIZYME Patents,
Collaboration Patents or Joint Patents, or otherwise fails to initiate and
maintain the defense of any such claim, suit, or proceeding, then the other
Party may conduct and control the defense of any such claim, suit, or proceeding
at its own expense.

8.6.3 Cooperation. Each Party shall assist and cooperate with the other Party as
such other Party may reasonably request from time to time in connection with its
activities set forth in this Section 8.6, including by being joined as a party
plaintiff in such action or proceeding, providing access to relevant documents
and other evidence, and making its employees available at reasonable business
hours. In connection with any such defense or claim or counterclaim, the
controlling Party shall consider in good faith any comments from the other Party
and shall keep the other Party reasonably informed of any steps taken, and shall
provide copies of all documents filed, in connection with such defense, claim,
or counterclaim. In connection with the activities set forth in this
Section 8.6, each Party shall consult with the other as to the strategy for the
defense of the EPIZYME Patents, Collaboration Patents and Joint Patents.

8.7 Third Party Licenses. If in the reasonable opinion of the Applicable
Commercialization Party, the Development, Manufacture, or Commercialization of
any Licensed Compound or Licensed Product by the Applicable Commercialization
Party, any of its Affiliates, or any of its or their Sublicensees infringes or
misappropriates any Patent, trade secret, or other intellectual property right
of a Third Party in any country in such Party’s part of the Territory, such that
the Applicable Commercialization Party, any of its Affiliates or any of its or
their Sublicensees cannot Develop, Manufacture, or Commercialize such Licensed
Compound or Licensed Product in such country without infringing such Patent,
trade secret, or other intellectual property right of such Third Party, then the
Applicable Commercialization Party shall have the right, but not the obligation,
to negotiate and obtain a license from such Third Party as necessary for the
Applicable Commercialization Party and its Affiliates, and its and their
Sublicensees to Develop, Manufacture, and Commercialize Licensed Compounds and
Licensed Products in such country.

8.8 Ownership and Prosecution of Product Trademarks. The Applicable
Commercialization Party shall own all right, title, and interest to the
trademarks used with respect to the Licensed Products in such Party’s part of
the Territory, and shall be responsible for the registration, prosecution,
maintenance and enforcement thereof. For clarity, EISAI may use the same
trademarks in the EISAI Territory with respect to the Licensed Products as
EPIZYME uses in the EPIZYME Territory with respect to the Licensed Products, and
EISAI shall own such trademarks in the EISAI Territory, provided that: (i) EISAI
shall not use such trademarks with respect to any products or services other
than Licensed Products and (ii) upon the effectiveness of the license granted to
EPIZYME under Section 12.5.1(d), if applicable, EISAI agrees to assign and
hereby does assign to EPIZYME all right, title and interest in and to such
trademarks in the EISAI Territory.

 

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ARTICLE 9

CONFIDENTIALITY

9.1 Confidentiality; Exceptions. Except to the extent expressly authorized by
this Agreement or otherwise agreed in writing, the Parties agree that 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 any Know-How or other information and materials, patentable or
otherwise, in any form (written, oral, photographic, electronic, magnetic, or
otherwise) which is disclosed to it by the other Party (the “Disclosing Party”)
or otherwise received or accessed by a Receiving Party in the course of
performing its obligations or exercising its rights under this Agreement,
including trade secrets, Know-How, inventions or discoveries, proprietary
information, formulae, processes, techniques and information relating to a
Party’s past, present and future marketing, financial and Development activities
of any product or potential product or useful technology of the Disclosing Party
and the pricing thereof (collectively, “Confidential Information”), except to
the extent that it can be established by the Receiving Party that such
Confidential Information:

(a) was in the lawful knowledge and possession of the Receiving Party prior to
the time it was disclosed to, or learned by, the Receiving Party, or was
otherwise developed independently by the Receiving Party, as evidenced by
written records kept in the ordinary course of business, or other documentary
proof of actual use by the Receiving Party;

(b) was generally available to the public or otherwise part of the public domain
at the time of its disclosure to the Receiving Party;

(c) became generally available to the public or otherwise part of the public
domain after its disclosure and other than through any act or omission of the
Receiving Party in breach of this Agreement; or

(d) was disclosed to the Receiving Party, other than under an obligation of
confidentiality, by a Third Party who had no obligation to the Disclosing Party
not to disclose such information to others.

9.2 Product Information. EPIZYME recognizes that by reason of, inter alia,
EISAI’s status as an exclusive licensee in the EISAI Territory under this
Agreement, EISAI has an interest in EPIZYME’s retention in confidence of certain
information of EPIZYME. Accordingly, until the end of all Royalty Term(s) in the
EISAI Territory, EPIZYME shall keep confidential, and not publish or otherwise
disclose, and not use for any purpose other than to fulfill EPIZYME’s
obligations, or exercise EPIZYME’s rights, hereunder any EPIZYME Know-How
Controlled by EPIZYME or EPIZYME Collaboration Know-How, in each case that are
primarily applicable to EZH2 or EZH2 Compounds (the “Product Information”),
except to the extent (a) the Product Information is in the public domain through
no fault of EPIZYME, (b) such disclosure or use is expressly permitted under
Section 9.3, or (c) such disclosure or use is otherwise expressly permitted by
the terms and conditions of this Agreement. For purposes of Section 9.3, each
Party shall be deemed to be both the Disclosing Party and the Receiving Party
with respect to Product Information. For clarification, the disclosure by
EPIZYME to EISAI of Product Information shall not cause such Product Information
to cease to be subject to the

 

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provisions of this Section 9.2 with respect to the use and disclosure of such
Confidential Information by EPIZYME. In the event this Agreement is terminated
pursuant to Article 12, this Section 9.2 shall have no continuing force or
effect, but the Product Information, to the extent disclosed by EPIZYME to EISAI
hereunder, shall continue to be Confidential Information of EPIZYME, subject to
the terms of Sections 9.1 and 9.3 for purposes of the surviving provisions of
this Agreement. Each Party shall be responsible for compliance by its
Affiliates, and its and its Affiliates’ respective officers, directors,
employees and agents, with the provisions of Section 9.1 and this Section 9.2.

9.3 Authorized Disclosure. Except as expressly provided otherwise in this
Agreement, a Receiving Party may use and disclose Confidential Information of
the Disclosing Party as follows:

(a) under appropriate confidentiality provisions similar to those in this
Agreement, in connection with the performance of its obligations or exercise of
rights granted or reserved in this Agreement (including the rights to Develop
and Commercialize Licensed Compounds or Licensed Products and to grant licenses
and sublicenses hereunder);

(b) to Regulatory Authorities as required in connection with any filing,
application or request for Regulatory Approval; provided, however, that
reasonable measures shall be taken to assure confidential treatment of such
information;

(c) in response to a valid order of a court of competent jurisdiction or other
supra-national, federal, national, regional, state, provincial and local
governmental or regulatory body of competent jurisdiction or, if so advised by
the Receiving Party’s legal counsel, such disclosure is otherwise required by
Law, including by reason of filing with securities regulators; provided,
however, that, to the extent practicable, the Receiving Party shall first have
given notice to the Disclosing Party and given the Disclosing Party a reasonable
opportunity to quash such order or to obtain a protective order or confidential
treatment requiring that the Confidential Information and documents that are the
subject of such order be held in confidence by such court or agency or, if
disclosed, be used only for the purposes for which the order was issued; and
provided further that the Confidential Information disclosed in response to such
court or governmental order shall be limited to that information which is
legally required to be disclosed in response to such court or governmental
order;

(d) to a patent authority as may be reasonably necessary or useful for purposes
of obtaining or enforcing a Patent with respect to which the Receiving Party has
the right or responsibility to conduct such activities hereunder; provided,
however, that reasonable measures shall be taken to assure confidential
treatment of such information, to the extent such protection is available;

(e) in communication with actual or potential investors, lenders, acquirors,
merger partners, consultants, advisors, licensees, sublicensees, collaborators
or others on a need to know basis, in each case under appropriate
confidentiality provisions substantially equivalent to those of this Agreement;
or

(f) to the extent mutually agreed to in writing by the Parties.

 

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9.4 Press Release; Disclosure of Agreement.

9.4.1 Press Release. On or promptly after the Restatement Date, each Party shall
issue a public announcement of this amendment and restatement of the Prior
Agreement in the form attached hereto as (for EPIZYME’s announcement) Exhibit
C-1 and (for EISAI’s announcement) Exhibit C-2. Thereafter, the Parties shall
use good faith efforts to agree on joint press releases with respect to material
developments relating to the Development or Commercialization of Licensed
Products; provided that (a) EPIZYME shall have the right, without having to
obtain EISAI’s consent, to issue press releases or make other public
announcements or disclosures with respect to Licensed Products (but not the
terms of this Agreement) if the Parties cannot agree on a joint press release
with respect thereto within five (5) Business Days after EPIZYME notifies EISAI
of EPIZYME’s desire to issue such press release; and (b) EISAI shall have the
right, without having to obtain EPIZYME’s consent, to issue press releases or
make other public announcements or disclosures with respect to the receipt by
EISAI of a payment for achievement of a milestone pursuant to Section 6.3.1 of
this Agreement if the Parties cannot agree on a joint press release with respect
thereto within five (5) Business Days after EISAI notifies EPIZYME of EISAI’s
desire to issue such press release.

9.4.2 Disclosure of Agreement Terms.

(a) Except to the extent required by Law or by securities exchange listing
requirements or as otherwise permitted in accordance with Section 9.4.1, neither
Party shall make any public announcements concerning this Agreement or the
subject matter hereof without the prior written consent of the other, which
shall not be unreasonably withheld, conditioned or delayed.

(b) Notwithstanding the foregoing, to the extent information regarding this
Agreement has already been publicly disclosed, either Party may subsequently
disclose the same information to the public without the consent of the other
Party to the extent such information remains accurate. Each Party shall also be
permitted to disclose the terms of this Agreement, in each case under
appropriate confidentiality provisions substantially equivalent to those of this
Agreement, to any actual or potential acquirors, merger partners, licensees,
sublicensees, collaborators, investors, lenders and professional advisors.

(c) Each Party shall give the other Party a reasonable opportunity to review
those portions of all filings with the United States Securities and Exchange
Commission (or any stock exchange, including Nasdaq, or any similar regulatory
agency in any country other than the U.S.) describing the terms of this
Agreement (including any filings of this Agreement) prior to submission of such
filings, and shall give due consideration to any reasonable comments by the
non-filing Party relating to such filing, including the provisions of this
Agreement for which confidential treatment should be sought.

9.5 Termination of Prior Confidentiality Agreement. This Agreement supersedes
and replaces the Confidentiality Agreement between EPIZYME and EISAI dated
July 13, 2010 (the “Existing Confidentiality Agreement”). All information
exchanged between the Parties under the Existing Confidentiality Agreement shall
be deemed Confidential Information hereunder and shall be subject to the terms
of this Article 9.

 

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9.6 Remedies. Each Party shall be entitled to seek, in addition to any other
right or remedy it may have, at Law or in equity, a temporary injunction,
without the posting of any bond or other security, enjoining or restraining the
other Party from any violation or threatened violation of this Article 9.

9.7 Publications.

9.7.1 Publications; Restrictions. Neither EISAI nor its Affiliates shall publish
or publicly disclose the results generated in the course of performing any of
the Development or Commercialization activities directed to EZH2 conducted by
the either Party under this Agreement without the prior written consent of
EPIZYME, except (i) EISAI may publish or publicly disclose the results generated
in the course of performing any Japan-Specific Development Activities conducted
by EISAI under this Agreement without such consent, subject to EISAI first
providing EPIZYME with an opportunity to review the proposed publication as set
forth in Section 9.7.2, or (ii) as otherwise expressly permitted in Section 9.8
or otherwise in this Agreement. EPIZYME may publish or publicly disclose the
results generated in the course of performing any of the Development or
Commercialization activities directed to EZH2 conducted by EPIZYME under this
Agreement without the prior written consent of EISAI, subject to EPIZYME first
providing EISAI with an opportunity to review the proposed publication as set
forth in Section 9.7.2, or as otherwise expressly permitted in Section 9.8 or
otherwise in this Agreement.

9.7.2 Submission; Review. The Party seeking to publish results hereunder (the
“publishing Party”) shall provide the other Party (the “reviewing Party”) with a
copy of such proposed abstract, manuscript, or presentation no less than fifteen
(15) days prior to its intended submission for publication. The reviewing Party
shall respond in writing promptly and in no event later than ten (10) days after
receipt of the proposed material, with one or more of the following:

(a) comments on the proposed material, which the publishing Party shall consider
in good faith;

(b) a specific statement of concern, based upon the need to seek patent
protection or to block publication if the reviewing Party determines that the
proposed disclosure is intellectual property that should be maintained as a
trade secret to protect a Compound or any Development activities conducted under
this Agreement; or

(c) an identification of the reviewing Party’s Confidential Information that is
contained in the material reviewed.

9.7.3 Patent and Trade Secret Protection. In the event of concern by the
reviewing Party over patent protection or whether maintaining a trade secret
would be a priority, the publishing Party agrees not to submit such publication
or to make such presentation that contains such information until the reviewing
Party is given a reasonable period of time, and in no event less than [**] days,
to seek patent protection for any material in such publication or presentation
which it believes is patentable or to resolve any other issues, or to abandon
such proposed publication or presentation if the reviewing Party reasonably
determines in good faith

 

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that maintaining such information as a trade secret is a commercially-reasonable
priority. Any Confidential Information of the reviewing Party shall, if
requested by the reviewing Party, be removed.

9.7.4 Review of Third Party Materials. With respect to any proposed abstracts,
manuscripts or summaries of presentations by investigators or other Third
Parties conducting Development with or on behalf of a Party hereunder, such
materials shall be subject to review by the other Party under this Section 9.7
to the same extent that EISAI or EPIZYME (as the case may be) has the right to
do so.

9.8 Clinical Trial Register. Each of EISAI and EPIZYME shall have the right to
list and publish summaries of data and results from any human clinical trials
conducted by such Party under this Agreement on its clinical trials registry or
on a government-sponsored database such as www.clinicaltrials.gov or other
publicly available websites such as www.clinicalstudyresults.org, without
requiring the consent of the other Party. The Parties shall discuss and
reasonably cooperate in order to facilitate the process to be employed in order
to ensure the publication of any such summaries of human clinical trials data
and results as required on the clinical trial registry of each Party and any
government-sponsored database such as clinicaltrials.gov or other publicly
available websites such as www.clinicalstudyresults.org, and shall provide
copies of such summaries to the other Party at least thirty (30) days prior to
the proposed publication date for the purposes of preparing any necessary patent
filings.

9.9 Use of Name. Except as expressly provided herein, neither Party shall
mention or otherwise use the name, logo, or trademark of the other Party or any
of its Affiliates (or any abbreviation or adaptation thereof) in any
publication, press release, marketing and promotional material, or other form of
publicity without the prior written approval of such other Party in each
instance. The restrictions imposed by this Section 9.9 shall not prohibit either
Party from making any disclosure identifying the other Party that is required by
Law. In addition, EPIZYME may use EISAI’s name, logo or trademark on EPIZYME’s
website to identify EISAI as one of EPIZYME’s collaborators provided that
EPIZYME complies with the formatting specifications provided by EISAI.

9.10 Return of Confidential Information. Upon the effective date of expiration
or termination of this Agreement for any reason, either Party may request in
writing, and the other Party shall either, with respect to Confidential
Information to which such first Party does not retain rights under the surviving
provisions of this Agreement: (i) promptly destroy all copies of such
Confidential Information in the possession of the other Party and confirm such
destruction in writing to the requesting Party; or (ii) promptly deliver to the
requesting Party, at the other Party’s expense, all copies of such Confidential
Information in the possession of the other Party; provided, however, that the
other Party shall be permitted to retain such Confidential Information for the
sole purpose of performing any continuing obligations hereunder or exercising
its rights hereunder that survive such termination (e.g., the exercise of its
rights under a license grant back). Notwithstanding the foregoing, such other
Party also shall be permitted to retain one (1) copy of such Confidential
Information for archival purposes and such additional copies of, or any computer
records or files containing, such Confidential Information that have been
created solely by such Party’s automatic archiving and back-up procedures, to
the extent created and retained in a manner consistent with such other Party’s
standard archiving and back-up procedures, but not for any other use or purpose.
All Confidential Information shall continue to be subject to the terms of this
Agreement for the period set forth in Section 12.6.2.

 

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ARTICLE 10

REPRESENTATIONS AND WARRANTIES

10.1 Representations and Warranties of Both Parties. Each Party hereby
represents, warrants and covenants to the other Party, as of the Restatement
Date, that:

10.1.1 Such Party is duly organized, validly existing and in good standing under
the Laws of the jurisdiction of its incorporation and has full corporate power
and authority to enter into this Agreement and to carry out the provisions
hereof;

10.1.2 Such Party has taken all necessary action on its part to authorize the
execution and delivery of this Agreement and the performance of its obligations
hereunder;

10.1.3 This Agreement has been duly executed and delivered on behalf of such
Party, and constitutes a legal, valid, binding obligation, enforceable against
it in accordance with the terms hereof;

10.1.4 The execution, delivery and performance of this Agreement by such Party
does not and will not conflict with any agreement or any provision thereof, or
any instrument or understanding, oral or written, to which it is or becomes a
party or by which it is or becomes bound, nor violate any Law or regulation of
any court, governmental body or administrative or other agency having
jurisdiction over such Party;

10.1.5 No government authorization, consent, approval, license, exemption of, or
filing or registration with any court or governmental department, commission,
board, bureau, agency or instrumentality, domestic or foreign, under any Laws
currently in effect, is necessary for its execution and delivery of this
Agreement; and

10.1.6 it has not (i) employed and has not used a contractor or consultant that
has employed, any Person debarred pursuant to Section 306 of the Federal Food,
Drug and Cosmetic Act (the “FFDCA”), or who is the subject of a conviction
described in such section (or subject to a similar sanction of EMA), or,
(ii) employed any Person that is the subject of an FDA debarment investigation
or proceeding (or similar proceeding of EMA), in the conduct of any pre-clinical
activities or clinical studies of Compounds.

10.2 Representations and Warranties of EPIZYME. EPIZYME hereby represents,
warrants and covenants to EISAI, as of the Restatement Date, that:

10.2.1 All EPIZYME Patents in the EISAI Territory existing as of the Restatement
Date are listed on Exhibit A (such EPIZYME Patents existing as of the
Restatement Date, collectively, the “Existing Patents”). To EPIZYME’s knowledge,
no issued patents included in the Existing Patents are invalid or unenforceable.

10.2.2 RESERVED.

 

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10.2.3 There are no claims, judgments or settlements against, or amounts with
respect thereto, owed by EPIZYME or any of its Affiliates relating to the
Existing Patents or the EPIZYME Know-How existing as of the Restatement Date
(such EPIZYME Know-How existing as of the Restatement Date, collectively, the
“Existing Know-How”). No claim or litigation has been brought or threatened
against EPIZYME or any of its Affiliates by any Person alleging, and EPIZYME has
no knowledge of any claim, whether or not asserted, that (a) the Existing
Patents are invalid or unenforceable, (b) the Existing Patents or the Existing
Know-How or the disclosing, copying, making, assigning or licensing of the
Existing Patents or the Existing Know-How, or the Development or
Commercialization of the Licensed Compounds or Licensed Products prior to the
Restatement Date has violated, infringed or otherwise conflicted or interfered
with, any intellectual property or proprietary right of any Person, or (c) the
disclosing, copying, making, assigning or licensing of the Existing Patents or
the Existing Know-How or the Development or Commercialization of the Licensed
Compounds or Licensed Products as contemplated herein would violate, infringe or
otherwise conflict or interfere with, any intellectual property or proprietary
right of any Person.

10.2.4 Except for any Existing Patents and Existing Know-How as to which EISAI
is a joint owner, EPIZYME is the sole and exclusive owner of the Existing
Patents and the Existing Know-How, free of any encumbrance, lien or claim of
ownership by any Third Party. EPIZYME is entitled to grant to EISAI the licenses
specified herein.

10.2.5 During the Term, EPIZYME shall not encumber or diminish its rights with
respect to the EPIZYME Patents, in each case if such encumbrance or diminution
would in any way adversely affect the rights and licenses granted to EISAI, or
the obligations of EISAI or EPIZYME, hereunder, without prior written consent of
EISAI.

10.2.6 To EPIZYME’s knowledge, the Existing Patents are being diligently
prosecuted in the respective patent offices in accordance with Law. All
applicable filing and maintenance fees with respect to the Existing Patents have
been paid on or before the due date for payment.

10.2.7 EPIZYME and its Affiliates have not previously assigned, transferred,
licensed, conveyed or otherwise encumbered its or their right, title or interest
in or to the Existing Patents that are primarily applicable to EZH2 or EZH2
Compounds, Existing Know-How that are primarily applicable to EZH2 or EZH2
Compounds, or any EZH2 Compound (including by granting any covenant not to sue
with respect thereto) or any Patents or Know-How that would be Existing Patents
or Existing Know-How, in each case that are primarily applicable to EZH2 or EZH2
Compounds, but for such assignment, transfer, license, conveyance or
encumbrance, except in each case where such assignment, transfer, license,
conveyance or encumbrance is terminated and no longer in force or effect, and
EPIZYME and its Affiliates will not enter into any such agreements or grant any
such right, title or interest to any Person that is inconsistent with the rights
and licenses granted to EISAI under this Agreement or EPIZYME’s obligations
under this Agreement.

10.2.8 To EPIZYME’s knowledge, no Person is infringing or threatening to
infringe the Existing Patents or misappropriating or threatening to
misappropriate the Existing Know-How.

 

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10.2.9 True, complete and correct copies of: (a) the file wrapper and other
material documents relating to the prosecution, defense, maintenance, validity
and enforceability of the Existing Patents were provided or made available to
EISAI prior to the Prior Agreement Date, and (b) all information known to
EPIZYME that EPIZYME believes to be materially adverse with respect to the
safety and efficacy of the EZH2 Compounds controlled by EPIZYME as of the
Restatement Date, were provided or made available to EISAI prior to the
Restatement Date.

10.2.10 To EPIZYME’s knowledge, the conduct of the Development activities
hereunder contemplated as of the Restatement Date will not infringe any Patent
or other intellectual property or proprietary right of any Person.

10.2.11 The conception, development and reduction to practice of the Existing
Patents and Existing Know-How have not constituted or involved the
misappropriation of trade secrets or other rights or property of any Person. The
conception, development and reduction to practice of Collaboration Patents and
Collaboration Know-How, in each case by or on behalf of EPIZYME and its
Affiliates prior to the Restatement Date, have not constituted or involved the
misappropriation of trade secrets or other rights or property of any Person.

10.2.12 In respect of the pending patent applications included in the Existing
Patents, EPIZYME has complied with its duty of candor to relevant patent
offices.

10.2.13 The Existing Patents represent all Patents within EPIZYME’s Control
relating to EZH2 Compounds in the EISAI Territory as of the Restatement Date. To
EPIZYME’s knowledge, there is no Know-How Controlled by EPIZYME as of the
Restatement Date that relates to EZH2 Compounds that is not within the Existing
Know-How.

10.2.14 To EPIZYME’s knowledge, each of the Existing Patents properly identifies
each and every inventor of the claims thereof as determined in accordance with
the laws of the jurisdiction in which such Existing Patent is issued or such
application is pending.

10.2.15 To EPIZYME’s knowledge, each Person who has or has had any rights in or
to any Existing Patent or any Existing Know-How, has assigned and has executed
an agreement assigning its entire right, title and interest in and to such
Existing Patent and Existing Know-How to EPIZYME.

10.2.16 No material Existing Know-How owned by EPIZYME have been disclosed or
authorized to be disclosed to any Third Party not subject to confidentiality
obligations to EPIZYME, and, to EPIZYME’s knowledge, no Third Party to such a
nondisclosure agreement with EPIZYME is in breach or default thereof. EPIZYME
has implemented reasonable policies and procedures to protect and maintain the
confidentiality of Existing Know-How.

10.2.17 All information, documentation and other materials furnished or made
available by EPIZYME upon the request of EISAI during EISAI’s period of
diligence prior to the Prior Agreement Effective Date were, as of the date such
information, documentation or materials were furnished or made available to
EISAI, true, complete and correct copies of what they purport to be.

 

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10.2.18 EPIZYME and its Affiliates have conducted, and, to EPIZYME’s knowledge,
their respective contractors and consultants have conducted, all Development of
Licensed Compounds or the Licensed Products that they have conducted prior to
the Restatement Date, in accordance with Law.

10.3 Representations and Warranties of EISAI. EISAI hereby represents and
warrants to EPIZYME, as of the Restatement Date, that (a) to EISAI’s knowledge,
neither EISAI nor any Affiliate owns or controls any rights to EZH2 Compounds
except for Licensed Compounds to which it has been granted rights hereunder,
(b) EISAI is entitled to grant to EPIZYME the licenses specified herein, and
(c) the conception, development and reduction to practice of Collaboration
Patents and Collaboration Know-How, in each case by or on behalf of EISAI and
its Affiliates prior to the Restatement Date, have not constituted or involved
the misappropriation of trade secrets or other rights or property of any Person.

10.4 Mutual Covenants. Each Party hereby covenants to the other Party that:

(a) All employees of such Party or its Affiliates working under this Agreement
will be under the obligation to assign all right, title and interest in and to
their inventions and discoveries, whether or not patentable, to such Party as
the sole owner thereof;

(b) It shall not use in any capacity, in connection with the performance of the
activities contemplated by this Agreement, any Person who has been debarred
pursuant to Section 306 of the FFDCA, or who is the subject of a conviction
described in such section (or subject to a similar sanction of EMA). It agrees
to inform the other Party in writing immediately if it or any Person who is
performing services hereunder on its behalf is debarred or is the subject of a
conviction described in Section 306, or if any action, suit, claim,
investigation or legal or administrative proceeding is pending or, to its
knowledge, is threatened, relating to the debarment or conviction of it or any
Person performing services hereunder; and

(c) Neither Party shall, during the Term, grant any right or license to any
Third Party relating to any of the intellectual property rights it owns or
Controls which would conflict with any of the rights or licenses granted to the
other Party hereunder or any of such Party’s obligations hereunder.

10.5 Disclaimer. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT,
NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND,
EITHER EXPRESS OR IMPLIED, AND EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. Without
limiting the generality of the foregoing, each Party disclaims any warranties
with regards to: (a) the success of any study or test commenced under this
Agreement, or (b) the safety or usefulness for any purpose of the technology or
materials, including any Compounds, it provides or discovers under this
Agreement.

 

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ARTICLE 11

INDEMNIFICATION; INSURANCE

11.1 Indemnification by EISAI. EISAI shall indemnify, defend and hold harmless
EPIZYME and its Affiliates, and its and their respective directors, officers,
employees and agents, from and against any and all liabilities, damages, losses,
costs and expenses, including the reasonable fees of attorneys and other
professional Third Parties (collectively, “Losses”), arising out of or resulting
from any and all Third Party suits, claims, actions, proceedings or demands
(“Third Party Claims”) based upon:

(a) the negligence, recklessness or wrongful intentional acts or omissions of
EISAI or its Affiliates or its or their respective directors, officers,
employees and agents, in connection with EISAI’s performance of its obligations
or exercise of its rights under this Agreement;

(b) any breach of any representation or warranty or covenant made by EISAI under
Article 10 or any other provision under this Agreement;

(c) the Development that is actually conducted by or on behalf of EISAI, its
Affiliates or Sublicensees (excluding any Development carried out by or on
behalf of EPIZYME, its Affiliates or Sublicensees hereunder), the handling and
storage by or on behalf of EISAI, its Affiliates or Sublicensees of any chemical
agents or other compounds for the purpose of conducting Development by or on
behalf of EISAI, its Affiliates or Sublicensees, and the Manufacture and
Commercialization by EISAI, its Affiliates or Sublicensees of any Licensed
Compound or Licensed Product, including (i) any product liability, personal
injury, property damage or other damage resulting from any Licensed Compound or
Licensed Product distributed by or on behalf of EISAI, its Affiliates or
Sublicensees, and (ii) infringement of any Patent or other intellectual property
rights of any Third Party by EISAI, its Affiliates or Sublicensees, in each case
resulting from any of the foregoing activities described in this
Section 11.1(c); or

(d) the Development, Commercialization, or Manufacture of Compounds, Licensed
Compounds or Licensed Products anywhere in the world after the Term, including
the use of Marketing Related Materials, by or on behalf of EISAI or its
Affiliates or Third Party sublicensees;

in each case, provided that, such indemnity shall not apply to the extent
EPIZYME has an indemnification obligation pursuant to Section 11.2 for such
Loss, in which event each Party shall indemnify the other to the extent of their
respective liability for such Loss.

11.2 Indemnification by EPIZYME. EPIZYME shall indemnify, defend and hold
harmless EISAI and its Affiliates, and its and their respective directors,
officers, employees and agents, from and against any and all Losses, arising out
of or resulting from any and all Third Party Claims based upon:

(a) the negligence, recklessness or wrongful intentional acts or omissions of
EPIZYME or its Affiliates or its or their respective directors, officers,
employees and agents, in connection with EPIZYME’s performance of its
obligations or exercise of its rights under this Agreement;

 

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(b) any breach of any representation or warranty or covenant made by EPIZYME
under Article 10 or any other provision under this Agreement;

(c) the Development that is actually conducted by or on behalf of EPIZYME, its
Affiliates or Sublicensees (including Development carried out by EISAI or its
Affiliates pursuant to Exhibit B, but without expanding EPIZYME’s obligations to
pay the costs of any activities conducted pursuant to Exhibit B or Section 2.6
beyond EPIZYME’s payment obligations as set forth in Section 2.6.2 and otherwise
excluding any Development carried out by or on behalf of EISAI or its Affiliates
or Sublicensees; provided, however, that the Development which is to be carried
out by or on behalf of EPIZYME, its Affiliates or Sublicensees hereunder shall
not be considered or interpreted to be Development carried out by or on behalf
of EISAI or its Affiliates or Sublicensees), the handling and storage by or on
behalf of EPIZYME, its Affiliates or Sublicensees of any chemical agents or
other compounds for the purpose of conducting Development by or on behalf of
EPIZYME, its Affiliates or Sublicensees (including the handling and storage by
EISAI or its Affiliates of any chemical agents or other compounds pursuant to
Exhibit B), and the Manufacture and Commercialization by EPIZYME, its Affiliates
or Sublicensees of any Licensed Compound or Licensed Product, including (i) any
product liability, personal injury, property damage or other damage resulting
from any Licensed Compound or Licensed Product distributed by or on behalf of
EPIZYME, its Affiliates or Sublicensees, and (ii) infringement of any Patent or
other intellectual property rights of any Third Party by EPIZYME, its Affiliates
or Sublicensees, in each case resulting from any of the foregoing activities
described in this Section 11.2(c);

(d) any gross negligence, recklessness, wrongful intentional act or omission,
failure to comply with any Law, breach of any agreement with a Third Party, or
infringement of Patent or other intellectual property rights of any Third Party
by EPIZYME, its Affiliates or Third Party sublicensees with respect to any
Development, Commercialization, or Manufacture of Licensed Compounds or Licensed
Products anywhere in the world prior to the Prior Agreement Effective Date;

(e) the Development, Commercialization, or Manufacture of Compounds, Licensed
Compounds or Licensed Products anywhere in the world after the Term, including
the use of Marketing Related Materials, by or on behalf of EPIZYME or its
Affiliates or Third Party sublicensees; or

(f) the Development, Commercialization, or Manufacture of Compounds, Licensed
Compounds or Licensed Products in the EISAI Territory after the termination of
this Agreement with respect to the EISAI Territory, including the use of
Marketing Related Materials, by or on behalf of EPIZYME or its Affiliates or
Third Party sublicensees;

in each case, provided that, such indemnity shall not apply to the extent EISAI
has an indemnification obligation pursuant to Section 11.1 for such Loss, in
which event each Party shall indemnify the other to the extent of their
respective liability for such Loss.

 

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11.3 Procedure.

11.3.1 Notice of Claim. A Person seeking indemnification under this Article 11
(an “Indemnified Party”) shall give prompt written notification to the Party
from whom indemnification is sought (the “Indemnifying Party”) of the Third
Party Claim for which indemnification may be sought (it being understood and
agreed, however, that the failure by an Indemnified Party to give notice of a
Third Party Claim as provided in this Section 11.3 shall not relieve the
Indemnifying Party of its indemnification obligation under this Agreement except
and only to the extent that such Indemnifying Party is actually prejudiced as a
result of such failure to give notice).

11.3.2 Assumption of Defense; Participation. Within [**] days after delivery of
such notification, the Indemnifying Party may, upon written notice thereof to
the Indemnified Party, assume control of the defense of such Third Party Claim
with counsel reasonably satisfactory to the Indemnified Party. If the
Indemnifying Party does not assume control of such defense, the Indemnified
Party shall control such defense and, without limiting the Indemnifying Party’s
indemnification obligations, the Indemnifying Party shall reimburse the
Indemnified Party for all costs and expenses, including reasonable attorneys’
fees and disbursements, incurred by the Indemnified Party in defending itself
within [**] days after receipt of any invoice therefor from the Indemnified
Party. The Party not controlling such defense may participate therein at its own
expense; provided, however, that, if the Indemnifying Party assumes control of
such defense and the Indemnified Party in good faith concludes, based on written
advice from outside counsel, that the Indemnifying Party and the Indemnified
Party have conflicting interests with respect to such Third Party Claim
sufficiently adverse to make unadvisable the representation by the same counsel
of both Parties under Law, ethical rules or equitable principles, the
Indemnifying Party shall be responsible for the reasonable fees and expenses of
a single counsel to the Indemnified Party in connection therewith. The Party
controlling such defense shall keep the other Party advised of the status of
such Third Party Claim and the defense thereof and shall consider
recommendations made by the other Party with respect thereto.

11.3.3 Settlements. The Indemnified Party shall not agree to any settlement of
such Third Party Claim without the prior written consent of the Indemnifying
Party, which shall not be unreasonably withheld, delayed or conditioned. The
Indemnifying Party shall not agree to any settlement of such Third Party Claim
or consent to any judgment in respect thereof that does not include a complete
and unconditional release of the Indemnified Party from all liability with
respect thereto, that imposes any liability or obligation on the Indemnified
Party or that acknowledges fault by the Indemnified Party, without the prior
written consent of the Indemnified Party.

11.4 Insurance.

11.4.1 EPIZYME’s Insurance Obligations. EPIZYME shall maintain, at its cost,
insurance against liability and other risks associated with its activities and
obligations under this Agreement, in such amounts, subject to such deductibles
and on such terms as are customary for a company such as EPIZYME for the
activities to be conducted by it under this Agreement. EPIZYME shall furnish to
EISAI evidence of such insurance upon request.

 

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11.4.2 EISAI’s Insurance Obligations. EISAI shall maintain self-insurance
against liability and other risks associated with its activities and obligations
under this Agreement, including its Clinical Trials and the Commercialization of
Licensed Products, in such amounts and on such terms as are customary for a
company such as EISAI for the activities to be conducted by it under this
Agreement. EISAI shall furnish to EPIZYME evidence of such self-insurance upon
request.

11.5 LIMITATION OF LIABILITY. EXCEPT FOR A BREACH OF ARTICLE 7 OR ARTICLE 9 OR
FOR CLAIMS OF A THIRD PARTY THAT ARE SUBJECT TO INDEMNIFICATION UNDER THIS
ARTICLE 11, NEITHER EPIZYME NOR EISAI, NOR ANY OF THEIR RESPECTIVE AFFILIATES OR
SUBLICENSEES, WILL BE LIABLE TO THE OTHER PARTY TO THIS AGREEMENT, ITS
AFFILIATES OR ANY OF THEIR SUBLICENSEES FOR ANY INDIRECT, INCIDENTAL,
CONSEQUENTIAL, SPECIAL OR PUNITIVE DAMAGES OR LOST PROFITS OR LOST ROYALTIES
(OTHER THAN ROYALTIES DUE TO THE OTHER PARTY HEREUNDER ON ACTUAL NET SALES),
LOST DATA OR COST OF PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES, WHETHER
LIABILITY IS ASSERTED IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT
LIABILITY), INDEMNITY OR CONTRIBUTION, AND IRRESPECTIVE OF WHETHER THAT PARTY OR
ANY REPRESENTATIVE OF THAT PARTY HAS BEEN ADVISED OF, OR OTHERWISE MIGHT HAVE
ANTICIPATED THE POSSIBILITY OF, ANY SUCH LOSS OR DAMAGE.

ARTICLE 12

TERM AND TERMINATION

12.1 Term; Expiration.

12.1.1 Term. This Agreement shall become effective on the Prior Agreement
Effective Date and, unless earlier terminated pursuant to this Article 12, shall
remain in effect until the expiration of all payment obligations under this
Agreement with respect to all Licensed Products in all countries in the
Territory (the “Term”).

12.1.2 Effect of Expiration of Royalty Term. After expiration of the applicable
Royalty Term with respect to a Licensed Product in a country in the Territory
(but not after earlier termination of this Agreement), the Applicable
Commercialization Party shall have a non-exclusive, fully-paid, royalty-free
right and license, with the right to grant sublicenses, under the Know-How and
Patents licensed to such Party hereunder, in each case as used at the time of
such expiration, to continue to Develop and Commercialize such Licensed Product
in the Field in such country, for so long as it continues to do so.

12.2 Unilateral Termination.

12.2.1 Termination for Convenience.

(a) EPIZYME shall have the right, at its sole discretion, exercisable at any
time to terminate this Agreement with respect to the EPIZYME Territory upon
ninety (90) days’ prior written notice to EISAI hereunder.

(b) EISAI shall have the right, at its sole discretion, exercisable at any time
to terminate this Agreement with respect to the EISAI Territory, upon ninety
(90) days’ prior written notice to EPIZYME hereunder.

 

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12.2.2 Cessation of Activities. Without limiting the generality of
Section 12.2.1, if a Party or its designated Affiliate or Sublicensee in all
material respects ceases (or fails to undertake) Development and
Commercialization activities with respect to all Licensed Compounds and Licensed
Products as to (with respect to EPIZYME) all of the United States, the United
Kingdom, Germany, France, Spain and Italy, or (with respect to EISAI) Japan
(excluding in each case temporary cessation during periods in which such Party
is using Commercially Reasonable Efforts to prepare to resume or commence
Development or Commercialization and temporary cessation during periods of [**]
months or less in which such Party is conducting a strategic review of Licensed
Products in order to determine whether to resume or commence Development or
Commercialization), then if such cessation or failure is consistent with the
exercise of Commercially Reasonable Efforts (and therefore not a breach of such
Party’s obligations to use Commercially Reasonable Efforts that is a basis for
termination by the other Party pursuant to Section 12.3), such cessation or
failure shall nonetheless be deemed to constitute a termination by the Party
which ceases or fails to undertake such Development and Commercialization
activities under Section 12.2.1 with respect to the EISAI Territory, in the case
of EISAI as the terminating Party, or with respect to the EPIZYME Territory, in
the case of EPIZYME as the terminating Party. For clarity, cessation under this
Section 12.2.2 with respect to a Party’s part of the Territory shall not be
deemed to have occurred if (i) such Party or its designated Affiliate or
Sublicensee is performing Development or Commercialization activities with
respect to at least one (1) Licensed Compound or Licensed Product with respect
to such Party’s part of the Territory or (ii) such Party or its Affiliate is
engaged in active negotiations with a Third Party in connection with a license
or sublicense in such Party’s part of the Territory with respect to any Licensed
Compound or Licensed Product.

12.3 Termination for Cause.

12.3.1 Termination for Material Breach.

(a) Either Party (the “Non-Breaching Party”) may, without prejudice to any other
remedies available to it under Law or in equity, terminate this Agreement if the
other Party (the “Breaching Party”) shall have materially breached in the
performance of its obligations hereunder, and such breach shall have continued
for [**] days (or, in the case of a payment breach, [**] days) after written
notice thereof was provided to the Breaching Party by the Non-Breaching Party,
such notice describing the alleged breach. Subject to Section 12.3.2, any such
termination of this Agreement under this Section 12.3.1 shall become effective
at the end of such [**] day (or [**] day, as applicable) cure period, unless:

(i) the Breaching Party has cured such breach prior to the expiration of such
cure period; or

(ii) such breach is not susceptible to cure within such cure period even with
the use of Commercially Reasonable Efforts, in which event the Non-Breaching
Party’s right to termination shall be suspended only if and for so long as
(A) the Breaching Party has

 

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provided to the Non-Breaching Party a written plan that is reasonably calculated
to effect a cure, (B) such plan is acceptable to the Non-Breaching Party, and
(C) the Breaching Party commits to and does carry out such plan; provided that,
unless otherwise mutually agreed by the Parties, in no event shall such
suspension of the Non-Breaching Party’s right to terminate extend beyond [**]
days after the original cure period.

(b) Notwithstanding the foregoing provisions of this Section 12.3.1, (i) if the
applicable material breach is a material breach by EISAI of its obligations
under Section 3.2.2, then EPIZYME’s termination right pursuant to this
Section 12.3.1 with respect to such breach shall be limited to a termination
only in the EISAI Territory, and (ii) if the applicable material breach is not a
material breach by EISAI of its obligations under Section 3.2.2, then EPIZYME
may elect to limit such termination to the EISAI Territory.

(c) Notwithstanding the foregoing provisions of this Section 12.3.1, (i) if the
applicable material breach is a material breach by EPIZYME of its obligations
under Section 3.2.1, then EISAI’s termination right pursuant to this Section
12.3.1 with respect to such breach shall be limited to a termination only in the
EPIZYME Territory, and (ii) if the applicable material breach is not a material
breach by EPIZYME of its obligations under Section 3.2.1, then EISAI may elect
to limit such termination to the EPIZYME Territory

(d) The right of either Party to terminate this Agreement, or a portion of this
Agreement, as provided in this Section 12.3.1 shall not be affected in any way
by such Party’s waiver or failure to take action with respect to any previous
material breach.

12.3.2 Disagreement. If the Parties reasonably and in good faith disagree as to
whether there has been a material breach, the Party that seeks to dispute that
there has been a material breach may contest the allegation in accordance with
Section 13.1. The cure period for any allegation made in good faith as to a
material breach under this Agreement will, subject to Sections 12.3.1 and 13.2,
run from the date that written notice was first provided to the Breaching Party
by the Non-Breaching Party.

12.4 Termination for EISAI Patent Challenge. If EISAI or any of its Affiliates
or Sublicensees:

(a) commences or otherwise voluntarily determines to participate in (other than
as may be necessary or reasonably required to assert a cross-claim or a
counter-claim or to respond to a court request or order or administrative law
request or order) any action or proceeding (including any patent opposition or
re-examination proceeding), challenging or denying the validity of any EPIZYME
Patent or Collaboration Patent owned by EPIZYME, or any claim of any of the
foregoing; or

(b) actively assists any other Person (other than as may be necessary or
reasonably required to assert a cross-claim or a counter-claim or to respond to
a court request or order or administrative law request or order) in bringing or
prosecuting any action or proceeding (including any patent opposition or
re-examination proceeding) challenging or denying the validity of any of such
Patents or any claim thereof (each activity under the foregoing clause (a) or
(b), an “EISAI Patent Challenge”);

 

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then EPIZYME shall have the right to terminate this Agreement upon thirty
(30) days’ written notice to EISAI.

12.5 Effects of Termination.

12.5.1 Termination by EISAI for Convenience; Termination by EPIZYME for Cause or
for Patent Challenge. If (w) this Agreement is terminated in its entirety as a
result of EISAI’s uncured breach pursuant to Section 12.3.1(a), (x) EPIZYME
terminates this Agreement with respect to EISAI Territory as a result of EISAI’s
uncured breach pursuant to Section 12.3.1(b), (y) EPIZYME terminates this
Agreement in its entirety as a result of an EISAI Patent Challenge pursuant to
Section 12.4, (z) EISAI terminates this Agreement with respect to the EISAI
Territory pursuant to Section 12.2.1(b) (including any deemed termination
pursuant to Section 12.2.2), then:

(a) Effect on Licenses. All licenses granted to EISAI under this Agreement shall
be terminated and of no further force or effect and all licenses granted to
EPIZYME under Section 5.2.1 of this Agreement shall survive and remain in full
force and effect; provided that such licenses under Section 5.2.1 shall be
limited to EISAI IP, Collaboration IP, and Joint IP in each case Controlled by
EISAI as of the effective date of termination and used as of the effective date
of termination in the Development, Manufacture or Commercialization of the
Licensed Compound(s) and Licensed Product(s) as they exist as of the date of
termination.

(b) Summary of Activities. Within [**] days after such termination, EISAI shall
provide to EPIZYME a fair and accurate summary report of the status and results
of its (and its Affiliates’ and Sublicensees’) Development and Commercialization
activities for Licensed Compounds and Licensed Products prior to the effective
date of termination in the Field in the EISAI Territory.

(c) Transition Assistance. Without limiting the generality of the remainder of
this Section 12.5.1, EISAI shall use its Commercially Reasonable Efforts, at
EPIZYME’s cost, to effect a seamless, timely transition to EPIZYME of all
Development, Manufacturing and Commercialization activities and responsibilities
for Licensed Compounds and Licensed Products in the EISAI Territory as they
exist as of the date of termination in accordance with a transition plan to be
mutually agreed by the Parties.

(d) License Grant to EPIZYME. Effective upon such termination, EISAI hereby
grants to EPIZYME a perpetual, irrevocable, royalty bearing (at the royalty
rate(s) specified in (A) Section 12.5.2(g)(i)(A), if such termination is a
termination described in the foregoing clause (z) of this Section 12.5.1 or
(B) Section 12.5.2(g)(i)(B)(1), if such termination is a termination described
in the foregoing clauses (w), (x) or (y) of this Section 12.5.1 and as if the
EISAI Territory were in ROW, in each case (A or B) subject to Sections 6.4.2,
6.4.3, 6.4.4, 6.4.5, 6.6, 6.7, 6.8, 6.9, 6.10 and 6.11, mutatis mutandis),
exclusive right and license (even as to EISAI and its Affiliates), with the
right to grant sublicenses, under all EISAI IP, Collaboration IP, and Joint IP
in each case Controlled by EISAI as of the effective date of termination and
used as of the effective date of termination in the Development, Manufacture or
Commercialization of the Licensed Compound(s) and Licensed Product(s) as they
exist as of the date of termination, solely to continue to Develop, Manufacture
or Commercialize such Licensed Compound(s) and Licensed Product(s) in the Field
in the EISAI Territory; provided that:

(i) the foregoing license shall exclude any license or other rights with respect
to any therapeutically active pharmaceutical ingredient that is not a Licensed
Compound and which is covered by Patents Controlled by EISAI or any of its
Affiliates;

 

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(ii) EISAI shall provide EPIZYME with copies of any and all Third Party
agreements with respect to the EISAI IP and EISAI Collaboration IP that is the
subject of the license granted by EISAI to EPIZYME pursuant to this
Section 12.5.1(d) and EPIZYME may at any time thereafter exclude any or all of
the EISAI IP and EISAI Collaboration IP that is the subject of any such Third
Party agreement from the grant set forth in this Section 12.5.1(d) by written
notice to EISAI, in which event clause (iii) below shall not apply thereafter to
such Third Party agreement and EPIZYME shall have no obligations with respect to
any amounts that may become payable under such Third Party agreement;

(iii) EPIZYME shall be responsible for (A) making any payments (including
royalties, milestones and other amounts) payable by EISAI to Third Parties under
any such Third Party agreements that are applicable to the grant to EPIZYME of
such license or to the exercise of such license by EPIZYME or any of its
Affiliates or sublicensees, by making such payments directly to EISAI and, in
each instance, EPIZYME shall make the requisite payments to EISAI and provide
the necessary reporting information to EISAI in sufficient time to enable EISAI
to comply with its obligations under such Third Party agreements, and
(B) complying with any other obligations included in any such Third Party
agreements that are applicable to the grant to EPIZYME of such license or to the
exercise of such license by EPIZYME or any of its Affiliates or sublicensees;
and

(iv) EISAI shall be responsible for paying or providing to any such Third Party
any payments or reports made or provided by EPIZYME under this
Section 12.5.1(d).

(e) Clinical Development Activities. With respect to any clinical Development
activities in the EISAI Territory that are in progress at the time of notice of
termination, (i) EPIZYME may elect, in its sole discretion, to complete such
clinical Development activities, in which event EISAI shall transfer to EPIZYME
(or its designee) all such clinical Development activities as part of the
transition plan to be mutually agreed by the Parties under clause (c) above, at
EPIZYME’s expense, or (ii) if EPIZYME does not elect to complete such clinical
Development activities, EISAI shall promptly discontinue or wind-down, at
EISAI’s cost, any such clinical Development activities, and forward all interim
and final reports and underlying data from such activities to EPIZYME (or its
designee).

(f) Regulatory Filings. To the extent permitted by Law, EISAI will promptly
assign to EPIZYME all Regulatory Approvals, Regulatory Dossiers and Regulatory
Materials for Licensed Products in the EISAI Territory. If EISAI is restricted
under Law from transferring ownership of any of the foregoing items to EPIZYME
(including in order to continue to conduct any transition activities as
contemplated in this Section 12.5.1, including the conduct of clinical
Development activities, if applicable, pursuant to Section 12.5.1(e) above),
EISAI shall grant

 

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EPIZYME (or its designee) a right of reference or use to such item (it being
understood that EISAI shall use Commercially Reasonable Efforts to transfer the
same to EPIZYME after the completion of such transition activities). EISAI shall
take all actions reasonably necessary to effect such transfer or grant of right
of reference or use to EPIZYME, including by making such filings as may be
required with Regulatory Authorities and other Governmental Authorities in the
Territory that may be necessary to record such assignment or effect such
transfer.

(g) Marketing-Related Materials. Upon EPIZYME’s request, EISAI will promptly
transfer and deliver to EPIZYME (or its designee) all promotional materials used
by EISAI as of the effective date of termination in the promotion of Licensed
Products in the EISAI Territory (“Marketing-Related Materials”) and effective on
such termination EISAI hereby grants to EPIZYME a perpetual, irrevocable, fully
paid-up, non-exclusive license, with the right to grant sublicenses, to
reproduce, distribute, display, use, modify and exploit, directly or indirectly,
any such Marketing-Related Materials, in each case solely in connection with the
exploitation of the Licensed Products; provided that neither EPIZYME nor any of
its Affiliates or sublicensees shall have any right or license to reproduce,
distribute, display, use, modify or exploit any corporate name or logo of EISAI
or its Affiliates on such materials. EPIZYME ACKNOWLEDGES AND AGREES THAT
(A) EISAI MAKES NO REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED,
WITH RESPECT TO THE USE OF SUCH MATERIALS, INCLUDING ANY WARRANTY THAT THE
MATERIALS ARE FIT FOR ANY PURPOSE OR THAT THE MATERIALS WILL NOT INFRINGE THE
INTELLECTUAL PROPERTY RIGHTS OF ANY PERSON OR ENTITY, AND (B) NEITHER EISAI NOR
ITS AFFILIATES SHALL HAVE ANY LIABILITY OF ANY KIND TO EPIZYME, ITS AFFILIATES
OR ANY THIRD PARTY RESULTING FROM OR IN CONNECTION WITH THE USE OF ANY SUCH
MATERIALS BY ANY PERSON OR ENTITY.

(h) Trademarks. If the First Commercial Sale of any Licensed Products in the
EISAI Territory has occurred as of the effective date of termination, at
EPIZYME’s request and cost, EISAI shall assign to EPIZYME any EISAI trademark(s)
used with respect to Licensed Products (other than EISAI’s company-specific
names and company-specific logos) for use solely in connection with such
Licensed Product.

(i) Transfer of Data. Upon EPIZYME’s request, EISAI will promptly provide to
EPIZYME (or its designee) copies of pharmacological, toxicological and clinical
test data and results, research data, reports and batch records, safety data and
all other data, including CMC-related information, formulation information,
chemistry and biology data, Controlled by EISAI as of the effective date of
termination and used as of the effective date of termination in the Development,
Manufacture or Commercialization in the EISAI Territory of the Licensed Products
as they exist as of the effective date of termination and which has not
previously been provided to EPIZYME.

(j) Contracts. EISAI shall assign to EPIZYME, to the extent assignable and
included in the transition plan to be agreed by the Parties under clause
(c) above, EISAI’s rights in any or all Third Party agreements for licenses,
services or supplies used in connection with the Development, Manufacture or
Commercialization of Licensed Products in the EISAI Territory, including any
Third Party manufacturing agreements and clinical trial agreements (subject to

 

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clause (e) above), unless any such agreement covers Combination Products in
which any active pharmaceutical ingredient that is not a Licensed Compound is
covered by Patents Controlled by EISAI or any of its Affiliates. In any
manufacturing agreement relating to the Licensed Products, EISAI shall use
Commercially Reasonable Efforts to require that the agreement be assignable to
EPIZYME upon termination of this Agreement. To the extent that any such
agreement is not assignable by EISAI, then such agreement will not be assigned,
and upon the request of EPIZYME, EISAI will cooperate in good faith and use
Commercially Reasonable Efforts to allow EPIZYME to obtain and to enjoy the
benefits of such agreement in the form of a license or other right to the extent
held by EISAI and subject to such Third Party’s rights. In addition, to the
extent that any such Third Party agreement is not specific to Licensed Products,
and EISAI needs to retain such agreement for its own purposes unrelated to the
applicable Licensed Products, EISAI will cooperate in good faith and use
Commercially Reasonable Efforts to allow EPIZYME to obtain and to enjoy the
benefits of such agreement with respect to the applicable Licensed Products in
the form of a sublicense, subcontract or other right, subject to such Third
Party’s rights.

(k) Manufacturing. Upon EPIZYME’s request, EISAI shall, as part of the
transition plan to be mutually agreed by the Parties under clause (c) above, at
EPIZYME’s expense, transfer to EPIZYME (or its designee) any processes,
documents, materials and other Know-How, to the extent the foregoing is
Controlled by EISAI as of the effective date of termination and used in the
Manufacture of Licensed Products in the Field as they exist as of the date of
termination.

(l) Existing Inventory. At EPIZYME’s election, EISAI will transfer to EPIZYME
such portion of EISAI’s existing inventory of Licensed Products (including
clinical trial materials and synthetic intermediates, if applicable) that
EPIZYME elects and, with respect to any commercial supply, that is in good and
saleable condition, in its original, unopened packaging, at [**].

(m) Prosecution and Enforcement. The provisions of Article 8 shall be
terminated, except Section 8.1. In addition, as between the Parties, EPIZYME
shall have the right (but not the obligation) to prosecute, maintain and enforce
all EISAI Collaboration Patents that are primarily applicable to EZH2 or EZH2
Compounds and licensed to EPIZYME pursuant to clause (d) above, under the same
terms and to the same extent as EPIZYME had the right to prosecute, maintain and
enforce the EISAI Collaboration Patents under Article 8 during the Term. EISAI
shall provide such assistance and cooperation as may be reasonably necessary in
connection with the transition of prosecution and enforcement responsibilities
to EPIZYME with respect to such EISAI Collaboration Patents, including execution
of such documents as may be necessary to effect such transition.

(n) EPIZYME Territory Obligations Remain. For clarity, if EISAI terminates this
Agreement with respect to the EISAI Territory pursuant to Section 12.2.1(b)
(including any deemed termination pursuant to Section 12.2.2), or EPIZYME
terminates this Agreement with respect to the EISAI Territory pursuant to
Section 12.3.1(b), this Agreement and all of the Parties’ rights and obligations
with respect to the EPIZYME Territory shall remain in full force and effect,
including EPIZYME’s obligations under Article 6; provided that, solely if
EPIZYME terminates this Agreement with respect to the EISAI Territory pursuant
to Section 12.3.1(b), on

 

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the effective date of such termination Section 6.3 shall be terminated and of no
further force or effect (but, for clarity, EPIZYME shall be obligated to pay in
accordance with Section 6.3.2 any milestone payment with respect to any
milestone event under Section 6.3.1 achieved as of the effective date of
termination but not paid by EPIZYME as of the effective date of termination).

(o) Payment Obligations. Any payment obligations that have accrued but that have
not been satisfied prior to the date of such termination shall survive.

12.5.2 Termination by EISAI for Cause; Termination by EPIZYME for Convenience.
If (x) EISAI terminates this Agreement with respect to the EPIZYME Territory
pursuant to Section 12.3.1(c) as a result of EPIZYME’s uncured breach, (y) EISAI
terminates this Agreement in its entirety pursuant to Section 12.3.1(a) as a
result of EPIZYME’s uncured material breach, or (z) EPIZYME terminates this
Agreement with respect to the EPIZYME Territory pursuant to Section 12.2.1(a)
(including any deemed termination pursuant to Section 12.2.2), then:

(a) Effect on Licenses. If EISAI elects to obtain a reversion as described in
Section 12.5.2(b) below, all licenses granted to EPIZYME under Section 5.2 shall
be terminated and of no further force and effect and, whether or not EISAI
elects to obtain such reversion, all licenses granted to EISAI under Section 5.1
shall survive and remain in full force and effect; provided that such licenses
under Section 5.1 shall be limited to EPIZYME IP, Collaboration IP, and Joint IP
in each case Controlled by EPIZYME as of the effective date of termination and
used as of the effective date of termination in the Development, Manufacture or
Commercialization of the Licensed Compound(s) and Licensed Product(s) as they
exist as of the date of termination. If EISAI does not elect to obtain a
reversion as described in Section 12.5.2(b) below, all licenses granted to
EPIZYME under Section 5.2.1 of this Agreement shall survive and remain in full
force and effect; provided that such licenses under Section 5.2.1 shall be
limited to EISAI IP, Collaboration IP, and Joint IP in each case Controlled by
EISAI as of the effective date of termination and used as of the effective date
of termination in the Development, Manufacture or Commercialization of the
Licensed Compound(s) and Licensed Product(s) as they exist as of the date of
termination.

(b) Reversion Option. EISAI shall have the right to elect, pursuant to written
notice provided to EPIZYME on or before the later of (i) the date that is [**]
days after the effective date of such termination and (ii) the date that is [**]
days after EPIZYME provides the report required by Section 12.5.2(j), for the
provisions set forth in Sections 12.5.2(c) through 12.5.2(i) to become
effective.

(c) License Grant to EISAI. Effective upon such termination, if EISAI elects to
obtain such license in accordance with Section 12.5.2(b), EPIZYME hereby grants
to EISAI a perpetual, irrevocable, royalty-bearing (as set forth in
Section 12.5.2(g)), exclusive right and license (even as to EPIZYME and its
Affiliates), with the right to grant sublicenses, under all EPIZYME IP,
Collaboration IP, and Joint IP in each case Controlled by EPIZYME as of the
effective date of termination and used as of the effective date of termination
in the Development, Manufacture or Commercialization of the Licensed Compound(s)
and Licensed Product(s) as they exist as of the date of termination, solely to
continue to Develop, Manufacture or Commercialize such Licensed Compound(s) and
Licensed Product(s) in the Field in the EPIZYME Territory; provided that:

(i) the foregoing license shall exclude any license or other rights with respect
to any therapeutically active pharmaceutical ingredient that is not a Licensed
Compound and which is covered by Patents Controlled by EPIZYME or any of its
Affiliates;

 

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(ii) EPIZYME shall provide EISAI with copies of any and all Third Party
agreements with respect to the EPIZYME IP and EPIZYME Collaboration IP that is
the subject of the license granted by EPIZYME to EISAI pursuant to this
Section 12.5.2(c) and EISAI may at any time thereafter exclude any or all of the
EPIZYME IP and EPIZYME Collaboration IP that is the subject of any such Third
Party agreement from the grant set forth in this Section 12.5.2(c) by written
notice to EPIZYME, in which event clause (iii) below shall not apply thereafter
to such Third Party agreement and EISAI shall have no obligations with respect
to any amounts that may become payable under such Third Party agreement;

(iii) EISAI shall be responsible for (1) making any payments (including
royalties, milestones and other amounts) payable by EPIZYME to Third Parties
under any such Third Party agreements that are applicable to the grant to EISAI
of such license or to the exercise of such license by EISAI or any of its
Affiliates or sublicensees, by making such payments directly to EPIZYME and, in
each instance, EISAI shall make the requisite payments to EPIZYME and provide
the necessary reporting information to EPIZYME in sufficient time to enable
EPIZYME to comply with its obligations under such Third Party agreements, and
(2) complying with any other obligations included in any such Third Party
agreements that are applicable to the grant to EISAI of such license or to the
exercise of such license by EISAI or any of its Affiliates or sublicensees;
provided that EPIZYME shall be solely responsible for and shall pay all amounts
payable to UNC under the UNC License Agreement (or under any other agreement
entered into by EPIZYME or any Affiliate and UNC); and

(iv) EPIZYME shall be responsible for paying or providing to any such Third
Party any payments or reports made or provided by EISAI under this
Section 12.5.2(c).

(d) Manufacturing. Upon EISAI’s request, EPIZYME shall, as part of the
transition plan to be mutually agreed by the Parties under clause (e) below, at
EISAI’s expense, transfer to EISAI (or its designee) any processes, documents,
materials and other Know-How, to the extent the foregoing is Controlled by
EPIZYME as of the effective date of termination and used in the Manufacture of
Licensed Products in the Field as they exist as of the date of termination;
provided that, upon EISAI’s request and pursuant to a supply agreement to be
negotiated in good faith by the Parties, at a purchase price equal to EPIZYME’s
Cost of Goods for clinical supplies and [**]% of EPIZYME’s Cost of Goods for
commercial supplies, supply EISAI with clinical and commercial quantities of the
Licensed Products for the EPIZYME Territory in the dosage strengths,
formulations and presentations under Development or being Commercialized by
EPIZYME, in either case, as of the effective date of termination, until the
earlier of: (A) [**] months after the effective date of termination; or
(B) establishment by EISAI of an alternative supply for such Licensed Products
on commercially reasonable terms.

(e) Prosecution and Enforcement. The provisions of Article 8 shall be
terminated, except Section 8.1. In addition, as between the Parties, EISAI shall
have the right (but not the obligation) to prosecute, maintain and enforce all
EPIZYME Collaboration Patents that are primarily applicable to EZH2 or EZH2
Compounds and licensed to EISAI pursuant to

 

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clause (a) above, under the same terms and to the same extent as EPIZYME had the
right to prosecute, maintain and enforce the EPIZYME Collaboration Patents under
Article 8 during the Term. EPIZYME shall provide such assistance and cooperation
as may be reasonably necessary in connection with the transition of prosecution
and enforcement responsibilities to EISAI with respect to such EPIZYME
Collaboration Patents, including execution of such documents as may be necessary
to effect such transition.

(f) Other Provisions.

(i) The effects of termination set forth in Sections 12.5.1(b), (c), (e), (f),
(g), (h), (i), (j), and (l) above shall apply mutatis mutandis, with “EISAI”
being substituted for “EPIZYME” and “EPIZYME” being substituted for “EISAI”.

(ii) If, as of the date of termination, none of EPIZYME, its Affiliates or
Sublicensees has been awarded a PRV in connection with the NDA for any Licensed
Product, then the provisions of Section 6.12 (FDA Priority Review Voucher) shall
apply mutatis mutandis, with “EISAI” being substituted for “EPIZYME” and
“EPIZYME” being substituted for “EISAI”.

(iii) If, as of the date of termination, EPIZYME, its Affiliate or Sublicensee
has been awarded a PRV in connection with the NDA for any Licensed Product but
such PRV has not been redeemed or transferred to a Third Party by EPIZYME, its
Affiliate or Sublicensee, then (A) within [**] days after EISAI’s election to
obtain a reversion as described in Section 12.5.2(b), EPIZYME shall, or shall
cause the applicable Affiliate or Sublicensee to, assign, convey and transfer to
EISAI all right, title and interest in and to such PRV for no additional
consideration, and (B) after such transfer the provisions of Section 6.12 (FDA
Priority Review Voucher) shall apply mutatis mutandis, with “EISAI” being
substituted for “EPIZYME” and “EPIZYME” being substituted for “EISAI”.

(iv) If, as of the date of termination, EPIZYME, its Affiliate or Sublicensee
has been awarded a PRV in connection with the NDA for any Licensed Product and
such PRV has been redeemed or transferred to a Third Party by EPIZYME, its
Affiliate or Sublicensee, then the provisions of Section 6.12 (FDA Priority
Review Voucher) shall survive in accordance with their terms.

(g) Royalties.

(i) Subject to Sections 6.4.2, 6.4.3, 6.4.4 and 6.4.5, mutatis mutandis, EISAI
shall pay EPIZYME:

(A) royalties of [**]% of Net Sales of each Therapeutic Product in Japan during
the Royalty Term for such Therapeutic Product in Japan, on a Therapeutic
Product-by-Therapeutic Product basis; and

(B) either:

(1) if EISAI terminates this Agreement with respect to the EPIZYME Territory
pursuant to Section 12.3.1(c) or EISAI terminates this Agreement in its

 

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entirety pursuant to Section 12.3.1(a), royalties on [**] Net Sales of each
Therapeutic Product in each country in ROW during the Royalty Term for such
Therapeutic Product in such country, on a Therapeutic Product-by-Therapeutic
Product and country-by-country basis, at the royalty rates set forth in the
table below:

 

[**] Net Sales

(For Each Therapeutic Product in Each Country)

   Incremental
Royalty Rates  

Portion up to and including $[**]

     [** ]% 

Portion greater than $[**]

     [** ]% 

For clarity, the royalty tiers set forth in the table above shall apply
separately to each separate Therapeutic Product and to each country in ROW. For
example: (x) if [**] Net Sales over the applicable Royalty Term in country Y for
Therapeutic Product A are $[**], and [**] Net Sales over the applicable Royalty
Term in country Y for Therapeutic Product B are $[**], then all such Net Sales
in country Y for both Therapeutic Product A and Therapeutic Product B shall bear
a royalty rate of [**]%; (y) if [**] Net Sales over the applicable Royalty Term
in country Y for Therapeutic Product A have exceeded $[**], then [**] Net Sales
in country Y of Therapeutic Product A up to and including $[**] shall bear a
royalty of rate of [**]% and all [**] Net Sales in country Y of Therapeutic
Product A in excess of $[**] shall bear a royalty rate of [**]% for the
remainder of the Royalty Term for Therapeutic Product A in country Y, and (z) if
[**] Net Sales over the applicable Royalty Term in country Y for Therapeutic
Product A have exceeded $[**] and [**] Net Sales in country Z for Therapeutic
Product A are $[**], then [**] Net Sales in country Y over the applicable
Royalty Term of Therapeutic Product A in excess of $[**] shall bear a royalty
rate of [**]% for the remainder of the Royalty Term for Therapeutic Product A in
country Y, and [**] Net Sales in country Z for Therapeutic Product A shall bear
a royalty rate of [**]% until [**] Net Sales in country Z of Therapeutic Product
A reach $[**], after which the [**] Net Sales in country Z of Therapeutic
Product A shall bear a royalty rate of [**]% for the remainder of the Royalty
Term for Therapeutic Product A in country Z; or

(2) if EPIZYME terminates this Agreement with respect to the EPIZYME Territory
pursuant to Section 12.2.1(a) (including any deemed termination pursuant to
Section 12.2.2), royalties of [**] percent ([**]%) on annual Net Sales of each
Therapeutic Product in each country in ROW during the Royalty Term for such
Therapeutic Product in such country, on a Therapeutic Product-by-Therapeutic
Product basis.

(ii) The provisions of Sections 6.6, 6.7, 6.8, 6.9, 6.10 and 6.11, mutatis
mutandis, shall apply to EISAI’s royalty payment obligations under Section
12.5.2(g).

 

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(h) Development Costs.

(i) If, as of the date of termination, no Licensed Product has achieved
Regulatory Approval in the United States or a Major EU Country (or by EMA
through the centralized approval procedure) for any Indication, then:

(1) EISAI shall reimburse EPIZYME for an amount equal to [**] percent ([**]%) of
all Development Costs incurred by EPIZYME in performing activities in connection
with the Development of Licensed Compounds and Licensed Products hereunder
during the period beginning on the Restatement Date and ending on the date of
termination, which amount shall be payable by EISAI in [**] equal installments
not later than the first Business Day of each of the first [**] Calendar
Quarters occurring after the date of EISAI’s election pursuant to
Section 12.5.2(b); and

(2) if, and only if, a Licensed Product achieves Regulatory Approval in the
United States or a Major EU Country (or by EMA through the centralized approval
procedure) for any Indication after the date of termination, EISAI shall
reimburse EPIZYME for an amount equal to [**] percent ([**]%) of all Development
Costs incurred by EPIZYME in performing activities in connection with the
Development of Licensed Compounds and Licensed Products hereunder during the
period beginning on the Restatement Date and ending on the date of termination,
which amount shall be payable by EISAI in [**] equal installments not later than
the first Business Day of each of the first [**] Calendar Quarters occurring
after the date of the first such Regulatory Approval.

(ii) If, as of the date of termination, at least [**] has achieved Regulatory
Approval in the United States or a Major EU Country (or by EMA through the
centralized approval procedure) for any Indication, then EISAI shall reimburse
EPIZYME for an amount equal to [**] incurred by EPIZYME in performing activities
in connection with the Development of Licensed Compounds and Licensed Products
hereunder during the period beginning on the Restatement Date and ending on the
date of the first such Regulatory Approval, which amount shall be payable by
EISAI in [**] equal installments not later than the first Business Day of each
of the first [**] Calendar Quarters occurring after the date of EISAI’s election
pursuant to Section 12.5.2(b).

(iii) EISAI shall, during the three (3) year period following EISAI’s election
pursuant to Section 12.5.2(b), have the right to have EPIZYME’s books and
records relating to the Development Costs reimbursable hereunder audited
pursuant to the terms of Sections 6.8.2 and 6.8.3, applied to this
Section 12.5.2(h) mutatis mutandis.

(i) Damages Offset. In the event EISAI validly elects to exercise its reversion
option as described under Section 12.5.2(b) and such option arose under
Section 12.5.2(x) or (y), then, without limiting the applicability of
Section 11.5, if EISAI makes a claim for damages against EPIZYME following such
reversion, EPIZYME shall be entitled to an offset against any damages to which
EISAI would otherwise be entitled equal to the [**] (as defined below). If EISAI
makes such a claim for damages, then the Parties shall, within [**] business
days of the date of such claim, engage a reputable investment banker mutually
agreeable to the parties (with agreement not to be unreasonably withheld or
delayed) with expertise in the biotechnology and pharmaceutical industries to
perform a monetary valuation of the rights and licenses granted or otherwise
transferred to EISAI under Sections 12.5.2(c) through (h). [**]. Each party
shall pay [**]% of the fees payable to the [**].

 

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(j) Report of Development Costs. Not later than thirty (30) days after the date
of termination, EPIZYME shall provide to EISAI a written report of all
Development Costs incurred by EPIZYME in performing activities in connection
with the Development of Licensed Compounds and Licensed Products hereunder
during the period beginning on the Restatement Date and ending on the date of
termination, which report shall be in reasonable detail, together with
reasonable evidence supporting such Development Costs.

(k) No Reversion. For the avoidance of doubt, the provisions of Sections
12.5.2(c) through 12.5.2(h) shall be of no force or effect unless and until
EISAI makes a valid election to that effect as specified under
Section 12.5.2(b). If EISAI does not make such election in accordance with
Section 12.5.2(b), then:

(i) EPIZYME’s obligations and EISAI’s rights under Article 6 shall survive such
termination (including, for clarity, if EPIZYME has ceased Development and
Commercialization of the Licensed Compounds and Licensed Products as of the date
of such termination but EPIZYME or its Affiliates restart Development or
Commercialization of the Licensed Compounds or Licensed Products after the date
of such termination).

(ii) In the event that EPIZYME or its Affiliates sell or otherwise transfer to a
Third Party ownership of assets relating to any Licensed Compound or Licensed
Product in the EPIZYME Territory in a transaction that does not involve the
assignment to and assumption by such Third Party of EPIZYME’s rights and
obligations under this Agreement pursuant to Section 13.4, such Third Party
shall agree, as a condition to any such sale or transfer, to fully assume the
obligations of EPIZYME set forth in Section 12.5.2(k)(i), in each case as such
obligations relate to such assets. Any purported sale or transfer of assets in a
transaction described above in this Section 12.5.2(k)(ii) that does not include
such assumption of obligations shall be null and void.

(iii) This Agreement and all of the Parties’ rights and obligations with respect
to the EISAI Territory shall remain in full force and effect.

(l) Payment Obligations. Any payment obligations that have accrued but that have
not been satisfied prior to the date of such termination shall survive.

12.6 Accrued Rights; Surviving Provisions.

12.6.1 Termination or expiration of this Agreement for any reason shall be
without prejudice to any rights that shall have accrued to the benefit of any
Party prior to such termination or expiration, including the payment obligations
under Article 7 hereof, and any and all damages or remedies arising from any
breach hereunder. Such termination or expiration shall not relieve any Party
from obligations which are expressly indicated to survive termination of this
Agreement.

12.6.2 The provisions of Sections 2.5.2, 5.3, 5.4, 6.12, 8.1, 10.5, 12.1.2,
12.5, 12.6, and Articles 1 (to the extent definitions are required to interpret
the surviving provisions of this Agreement), 6 (to the extent any amounts are
due but unpaid as of the effective date of termination and to the extent
provisions of Article 6 relate to payment obligations that otherwise

 

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survive pursuant to Section 12.5 in accordance with its terms), 9, 11 and 13
shall survive the termination of this Agreement in its entirety or expiration of
this Agreement, as applicable, in accordance with their respective terms and
conditions, and for the duration stated, and where no duration is stated, shall
survive indefinitely. Article 9 shall survive for a period of [**] years after
the effective date of termination or expiration of this Agreement.

ARTICLE 13

MISCELLANEOUS

13.1 Dispute Resolution. Except with respect to disputes described in
Section 1.70 and Section 6.12 and disputes as to matters within the authority of
the JSC, which shall be determined in accordance with Section 1.70, Section 6.12
and Section 4.1.5, respectively, and which shall not be subject to this
Section 13.1 (for purposes of clarity, neither shall such dispute be subject to
arbitration pursuant to Section 13.2), if a dispute between the Parties arises
under this Agreement, either Party shall have the right to refer such dispute in
writing to the respective Executive Officers, and such Executive Officers shall
attempt in good faith to resolve such dispute. If the Executive Officers are
unable to resolve a given dispute pursuant to this Section 13.1 within [**] days
after referring such dispute to the Executive Officers, either Party may have
the given dispute settled by binding arbitration pursuant to Section 13.2.

13.2 Arbitration Request. If a Party intends to begin an arbitration to resolve
a dispute arising under this Agreement, such Party shall provide written notice
(the “Arbitration Request”) to the other Party of such intention and a statement
of the issues for resolution. From the date of the Arbitration Request and until
such time as the dispute has become finally settled, the running of the time
periods as to which the other Party must cure a breach of this Agreement becomes
suspended as to any breach that is the subject matter of the dispute.

13.2.1 Additional Issues. Within [**] days after the receipt of the Arbitration
Request, the other Party may, by written notice, add additional issues for
resolution in a statement of counter-issues.

13.2.2 No Arbitration of Patent Issues. Any dispute, controversy or claim
relating to the scope, validity, enforceability, infringement, inventorship or
ownership of any Patents shall be submitted to a court of competent jurisdiction
in the country in which such patent rights apply.

13.2.3 Arbitration Procedure. Any arbitration pursuant to this Article 13 will
be held in New York, New York, United States unless another location is mutually
agreed by the Parties. The arbitration will be governed by the United States
Arbitration Act, 9 U.S.C. §§ 1-16, to the exclusion of any inconsistent state
Law. The Parties shall mutually agree on the rules to govern discovery and the
rules of evidence for the arbitration within [**] days after the Arbitration
Request. If the Parties fail to timely agree to such rules, the United States
Federal Rules of Civil Procedure will govern discovery and the United States
Federal Rules of Evidence will govern evidence for the arbitration. The
arbitration will be conducted by a single arbitrator knowledgeable in the
subject matter at issue in the dispute and acceptable to both Parties; provided
that, the Parties may by mutual agreement elect to have the arbitration
conducted by a panel of three (3) arbitrators. If the Parties fail to agree on a
mutually acceptable arbitrator

 

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within [**] days after the Arbitration Request, then the arbitrator shall be
selected by the New York, New York office of the AAA. The arbitrator may proceed
to an award, notwithstanding the failure of either Party to participate in the
proceedings. The arbitrator shall, within [**] days after the conclusion of the
arbitration hearing, issue a written award and statement of decision describing
the essential findings and conclusions on which the award is based, including
the calculation of any damages awarded. The arbitrator shall be limited in the
scope of his or her authority to resolving only the specific matter which the
Parties have referred to arbitration for resolution and shall not have authority
to render any decision or award on any other issues. Subject to Section 12.5,
the arbitrator shall be authorized to award compensatory damages, but shall not
be authorized to award punitive, special, consequential, or any other similar
form of damages, or to reform, modify or materially change this Agreement. The
arbitrator also shall be authorized to grant any temporary, preliminary or
permanent equitable remedy or relief the arbitrator deems just and equitable and
within the scope of this Agreement, including an injunction or order for
specific performance. The Parties hereby expressly agree to waive the right to
appeal from the decisions of the arbitrator, and there shall be no appeal to any
court or other authority (government or private) from the decision of the
arbitrator. Judgment on the award rendered by the arbitrator may be enforced in
any court having competent jurisdiction thereof, subject only to revocation of
the award on grounds set forth in the United Nations Convention on the
Recognition and Enforcement of Foreign Arbitral Awards.

13.2.4 Costs. Each Party shall bear its own attorneys’ fees, costs, and
disbursements arising out of the arbitration, and shall pay an equal share of
the fees and costs of the arbitrator.

13.2.5 Preliminary Injunctions. Notwithstanding anything in this Agreement to
the contrary, a Party may seek a temporary restraining order or a preliminary
injunction from any court of competent jurisdiction in order to prevent
immediate and irreparable injury, loss, or damage on a provisional basis,
pending the award of the arbitrator on the ultimate merits of any dispute.

13.2.6 Confidentiality. All proceedings and decisions of the arbitrator shall be
deemed Confidential Information of each of the Parties, and shall be subject to
Article 10.

13.3 Governing Law. This Agreement and any dispute arising from the performance
or breach hereof shall be governed by and construed and enforced in accordance
with the Laws of the State of New York excluding any conflicts or choice of law
rule or principle that might otherwise refer construction or interpretation of
this Agreement to the substantive law of another jurisdiction. The provisions of
the United Nations Convention on Contracts for the International Sale of Goods
shall not apply to this Agreement or any subject matter hereof.

13.4 Assignment. Neither Party may assign this Agreement without the consent of
the other Party, except as otherwise provided in this Section 13.4. Either Party
may assign this Agreement in whole or in part to any Affiliate of such Party
without the consent of the other Party; provided that, such assigning Party
provides the other Party with written notice of such assignment, the Affiliate
agrees in writing to assume performance of all assigned obligations, and the
assigning Party shall remain primarily liable for the performance of its
obligations under this Agreement by such Affiliate. Further, each Party may
assign this Agreement, and all of its

 

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rights and obligations hereunder, without the consent of the other Party, to its
successor in interest by way of merger or consolidation or in connection with
the sale of all or substantially all of its business or assets to which this
Agreement relates, and in the event of such an assignment the assigning Party
shall provide the other Party with written notice of such assignment and the
assignee shall be required to agree in writing to assume performance of all
assigned obligations; provided that if a Change of Control Event described in
Section 1.9(b) occurs, the assigning Party shall be required to assign this
Agreement, and all of its rights and obligations hereunder, to the acquiror of
all or substantially all of such Party business or assets to which this
Agreement relates and such assignee shall be required to agree with the other
Party in writing to assume performance of all assigned obligations. Any
purported assignment in violation of this Section 13.4 shall be null and void.

13.5 Performance Warranty. Each Party hereby acknowledges and agrees that it
shall be responsible for the full and timely performance as and when due under,
and observance of all the covenants, terms, conditions and agreements set forth
in this, Agreement by its Affiliate(s) and Sublicensees.

13.6 Force Majeure. No Party shall be held liable or responsible to the other
Party nor be deemed to be in default under, or in breach of any provision of,
this Agreement for failure or delay in fulfilling or performing any obligation
(other than a payment obligation) of this Agreement when such failure or delay
is due to force majeure, and without the fault or negligence of the Party so
failing or delaying. For purposes of this Agreement, force majeure is defined as
causes beyond the control of the Party, including acts of God; material changes
in Law; war; civil commotion; destruction of production facilities or materials
by fire, flood, earthquake, explosion or storm; labor disturbances; epidemic;
and failure of public utilities or common carriers. In such event EPIZYME or
EISAI, as the case may be, shall immediately notify the other Party of such
inability and of the period for which such inability is expected to continue.
The Party giving such notice shall thereupon be excused from such of its
obligations under this Agreement as it is thereby disabled from performing for
so long as it is so disabled for up to a maximum of ninety (90) days, after
which time EPIZYME and EISAI shall promptly meet to discuss in good faith how to
best proceed in a manner that maintains and abides by the Agreement. To the
extent possible, each Party shall use reasonable efforts to minimize the
duration of any force majeure.

 

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13.7 Notices. Any notice or request required or permitted to be given under or
in connection with this Agreement shall be deemed to have been sufficiently
given if in writing and personally delivered or sent by, facsimile transmission
(receipt verified), or international overnight express courier service
(signature required), prepaid, to the Party for which such notice is intended,
at the address set forth for such Party below:

 

If to EPIZYME, addressed to: Epizyme, Inc. 400 Technology Drive, 4th Floor
Cambridge, Massachusetts 02139 Attention: Chief Executive Officer Telephone:
(617) 229-5872 Facsimile: (617) 349-0707 with a copy to: WilmerHale LLP 60 State
Street Boston, MA 02109 Attention: Stuart M. Falber, Esq. Steven D. Barrett,
Esq. Telephone: (617) 526-6000 Facsimile: (617) 526-5000 If to EISAI, addressed
to: Eisai Co., Ltd. Koishikawa 4-6-10 Bunkyo-Ku Tokyo 112-8088 Japan Attention:
Chief Product Creation Officer Telephone: 81-3-3817-5149 Facsimile:
81-3-3811-1459 with copies to: Eisai Co., Ltd. Koishikawa 4-6-10 Bunkyo-Ku Tokyo
112-8088 Japan Attention: General Counsel Telephone: 81-3-3817-5089 Facsimile:
81-3-3811-5535

and

Eisai Inc. 100 Tice Blvd. Woodcliff Lake, NJ 07677 Attention: President General
Counsel Telephone: (201) 746-2305 Facsimile: (201) 746-3201

or to such other address for such Party as it shall have specified by like
notice to the other Party, provided that notices of a change of address shall be
effective only upon receipt thereof. If delivered personally or by facsimile
transmission, the date of delivery shall be deemed to be the

 

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day on which such notice or request was given, or if such day is not a Business
Day, the first Business Day thereafter. If sent by overnight express courier
service, the date of delivery shall be deemed to be the second Business Day
after such notice or request was deposited with such service.

13.8 Export Clause. Each Party acknowledges that the Laws of the United States
restrict the export and re-export of certain commodities and technical data of
United States origin. Each Party agrees that it will not export or re-export
restricted commodities or the technical data of the other Party in any form
without the appropriate United States and foreign government licenses.

13.9 Waiver. Neither Party may waive or release any of its rights or interests
in this Agreement except in writing. The failure of either Party to assert a
right hereunder or to insist upon compliance with any term of this Agreement
shall not constitute a waiver of that right or excuse a similar subsequent
failure to perform any such term or condition. No waiver by either Party of any
condition or term in any one or more instances shall be construed as a
continuing waiver of such condition or term or of another condition or term. The
rights and remedies provided herein are cumulative and do not exclude any other
right or remedy provided by Law or otherwise available except as expressly set
forth herein.

13.10 Severability. If any provision hereof should be held invalid, illegal or
unenforceable in any jurisdiction or otherwise directly or indirectly affects
the validity of any other material provision(s) of this Agreement (“Severed
Clause”), all other provisions hereof shall remain in full force and effect in
such jurisdiction except for such Severed Clause, and such invalidity,
illegality or unenforceability shall not affect the validity, legality or
enforceability of such provision in any other jurisdiction. The Parties shall
consult and use good faith efforts to agree upon a valid and enforceable
provision which shall be a reasonable substitute for such Severed Clause in
light of the intent of this Agreement.

13.11 Entire Agreement. This Agreement, together with the Exhibits hereto and
thereto, the Existing RMS Agreement and the Amended CDx Letter Agreement set
forth all the covenants, promises, agreements, warranties, representations,
conditions and understandings between the Parties with respect to the subject
matter of this Agreement, the Existing RMS Agreement and the Amended CDx Letter
Agreement and supersede and terminate all prior agreements and understandings
between the Parties with respect to the subject matter of this Agreement, the
Existing RMS Agreement and the Amended CDx Letter Agreement. In particular, and
without limitation, this Agreement supersedes and replaces the Existing
Confidentiality Agreement and any and all term sheets relating to the
transactions contemplated by this Agreement and exchanged between the Parties
prior to the Restatement Date. There are no covenants, promises, agreements,
warranties, representations, conditions or understandings, either oral or
written, between the Parties with respect to the subject matter of this
Agreement other than as set forth herein and therein. No subsequent alteration,
amendment, change or addition to this Agreement shall be binding upon the
Parties unless reduced to writing and signed by the respective authorized
officers of the Parties.

13.12 Independent Contractors. Nothing herein shall be construed to create any
relationship of employer and employee, agent and principal, partnership or joint
venture between

 

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the Parties. Each Party is an independent contractor. Neither Party shall
assume, either directly or indirectly, any liability of or for the other Party.
Neither Party shall have the authority to bind or obligate the other Party and
neither Party shall represent that it has such authority.

13.13 Non-solicitation of Key Employees. During the period commencing on the
Restatement Date and ending upon the termination or expiration of this Agreement
with respect to the EISAI Territory, neither Party shall solicit any Key
Employee to leave the employment of the other Party and accept employment or
work as a consultant with the soliciting Party. Notwithstanding the foregoing,
nothing herein shall restrict or preclude either Party’s right to make
generalized searches for employees by way of a general solicitation for
employment placed in a trade journal, newspaper or website. For purposes of this
Section 13.13, “Key Employee” means any employee who is material to the
performance of the Collaboration hereunder, including any members of the JSC or
any Subcommittee thereof.

13.14 Headings; Construction; Interpretation. Headings used herein are for
convenience only and shall not in any way affect the construction of or be taken
into consideration in interpreting this Agreement. The terms of this Agreement
represent the results of negotiations between the Parties and their
representatives, each of which has been represented by counsel of its own
choosing, and neither of which has acted under duress or compulsion, whether
legal, economic or otherwise. Accordingly, the terms of this Agreement shall be
interpreted and construed in accordance with their usual and customary meanings,
and each of the Parties hereto hereby waives the application in connection with
the interpretation and construction of this Agreement of any rule of Law to the
effect that ambiguous or conflicting terms or provisions contained in this
Agreement shall be interpreted or construed against the Party whose attorney
prepared the executed draft or any earlier draft of this Agreement. Any
reference in this Agreement to an Article, Section, subsection, paragraph,
clause or Exhibit shall be deemed to be a reference to any Article, Section,
subsection, paragraph, clause or Exhibit, of or to, as the case may be, this
Agreement. Except where the context otherwise requires, (a) any definition of or
reference to any agreement, instrument or other document refers to such
agreement, instrument other document as from time to time amended, supplemented
or otherwise modified (subject to any restrictions on such amendments,
supplements or modifications set forth herein or therein), (b) any reference to
any Law refers to such Law as from time to time enacted, repealed or amended,
(c) the words “herein,” “hereof” and “hereunder,” and words of similar import,
refer to this Agreement in its entirety and not to any particular provision
hereof, (d) the words “include,” “includes,” and “including,” shall be deemed to
be followed by the phrase “but not limited to,” “without limitation” or words of
similar import, (e) the word “or” is used in the inclusive sense (and/or) and
(f) the singular shall include the plural, the plural the singular, the use of
any gender shall be applicable to all genders.

13.15 Books and Records. Any financial books and records to be maintained under
this Agreement by a Party or its Affiliates or Sublicensees shall be maintained
in accordance with the accounting principles customarily used by such Person in
the applicable country (“GAAP”), consistently applied, except that the same need
not be audited.

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

 

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13.17 Parties in Interest. All of the terms and provisions of this Agreement
shall be binding upon, and shall inure to the benefit of and be enforceable by
the Parties hereto and their respective successors and permitted assigns. The
covenants and agreements set forth in this Agreement are for the sole benefit of
the Parties and their successors, permitted assigns and, with respect to
indemnification under Article 11, the indemnitees identified thereunder, and
they shall not be construed as conferring any rights on any other Persons.

13.18 Performance by Affiliates. To the extent that this Agreement imposes
obligations on Affiliates of a Party, such Party agrees to cause its Affiliates
to perform such obligations.

13.19 Counterparts. This Agreement may be signed in counterparts, each and every
one of which shall be deemed an original, notwithstanding variations in format
or file designation which may result from the electronic transmission, storage
and printing of copies from separate computers or printers. Facsimile signatures
and signatures transmitted via PDF shall be treated as original signatures.

13.20 Amendment and Restatement; No Novation. This Agreement constitutes an
amendment and restatement of the Prior Agreement effective from and after the
Restatement Date. The execution and delivery of this Agreement shall not
constitute a novation of any rights or obligations owing under the Prior
Agreement based on facts or events occurring or existing prior to the
Restatement Date. As of the Restatement Date, the Prior Agreement is hereby
amended, supplemented, modified and restated in its entirety as described
herein.

[Signature page to follow]

 

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IN WITNESS WHEREOF, and intending to be legally bound hereby, the Parties have
caused this Agreement to be executed by their duly authorized representatives as
of the Restatement Date.

 

Epizyme, Inc. By:

/s/ Robert Gould

Name: Robert Gould Title: President and CEO Eisai Co., Ltd. By:

/s/ Hideki Hayashi

Name: Hideki Hayashi Title: Representative Corporate Officer, Corporate Planning
& Strategy and Chief Information Officer

 

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EXHIBIT A

EPIZYME Patents

(as of the Restatement Date)

 

Origin

 

Country

 

Title

 

Inventor List

 

Appl’n
Status

 

Serial
Number

 

Filing Date

 

Publication
Number

 

Publication
Date

 

Patent
Number

 

Issue Date

 

Expiration
Date

                                                                 

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of seven pages were omitted. [**]

 

A-1

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

EXHIBIT B

Transition Matters

 

#

 

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

  CLINICAL     1   [**]     2   [**]   [**]   Epizyme will reimburse Eisai’s
external costs with [**]. Current Estimated costs for [**] to be $[**] 3   [**]
  [**]   Epizyme will reimburse Eisai internal costs of up to [**] FTE for [**]
at a rate of $[**]USD/FTE/month during the transition, actual duration as
determined by Epizyme (Total estimated to be [**]) 4   [**]   Letter to be sent
to Biotrials no later than [**] days after execution of the Agreement.   None 5
  [**]   Documents will be provided no later than [**] days days after execution
of the Agreement   None 6   [**]   Eisai will provide/ facilitate assistance
with transition of [**] to Epizyme and/or Epizyme’s [**], but no later than
[**].   Epizyme will reimburse Eisai internal costs of: 1) up to [**] FTE for
[**] at rate of $[**]USD/FTE/month for up to[**] months during transition (Total
estimated to be [**]) and 2) up to[**] FTE for [**] Support at a rate of $[**]
USD/FTE/month up to for up to [**] months (Total estimated to be [**]) during
transition as determined by Epizyme. Epizyme will reimburse Eisai internal costs
of up to [**] FTE for [**] at rate of $[**] USD/month as determined necessary by
Epizyme (Total cost of $[**]) currently anticipated to be [**]) 7   [**]  
Copies of all [**] will be provided to Epizyme within [**] days of execution of
the Agreement   None

 

B-1

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

#

 

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

8   [**]   Upon execution of Epizyme [**] and provide assistance for [**]days
following transfer completion   Epizyme will reimburse Eisai internal costs for
[**] of up to [**] FTE at rate of $[**] USD/FTE/month for up to [**] months
during the transition (estimated total of $[**]) and up to [**] FTE for up to
[**] following transition (estimated total of $[**]) in each case, as determined
necessary by Epizyme. 9   [**]   Upon execution of Epizyme [**] and provide
assistance for [**] days following transfer completion   Included in item #6 10
  [**]   Upon execution of Epizyme [**]   None 11   [**]   Documents existing as
of the completion of [**] will be added within [**] days of [**] Additional
documents generated during transition will be added within [**] days of document
creation.   None 12   [**]   Eisai will fully support [**]   Epizyme will
reimburse Eisai’s external costs with [**] upon assignment Epizyme will
reimburse Eisai internal costs of: 1) up to [**] FTE for [**] at rate of
$[**]USD/FTE/month for up to [**] months during transition (estimated total of
$[**]) and 2) up to [**] FTE for [**] at a rate of $[**]USD/FTE/month up to for
up to [**] months (estimated total of $[**]) during transition as determined by
Epizyme. Epizyme will reimburse Eisai internal costs of up to [**] FTE for [**]
at rate of $[**] USD/FTE/month for up to [**] months (estimated total of $[**])
as determined by Epizyme. 13   [**]   Upon execution of Agreement at mutually
agreeable times as needed upon request from Epizyme during through [**]   None

 

B-2

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

#

 

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

14   [**]   Confirmation of complete list and receipt of copies to be completed
within [**] days of executing the Agreement   None 15   [**]   Through
completion of [**] can be assigned by Eisai to Epizyme, upon all parties mutual
agreement.   Epizyme will reimburse Eisai’s external costs with [**] after the
execution of the Restated Agreement and then assume any additional costs/payment
of [**] after execution of Epizyme [**] or Eisai Assignment of [**]assignment
Reimbursement by Epizyme for actual invoices received by Eisai from [**] Current
Estimated costs for [**] months to be estimated at $[**] 16   [**]   Letter to
be sent to [**] no later than [**] days after execution of the Agreement.   None
17   [**]   Complete [**] and provided to Epizyme within [**] days of execution
of the Agreement and samples to be transferred to Epizyme’s [**] and no later
than or upon regulatory approval of Epizyme’s [**].   shipping to be reimbursed
18   [**]   After approval of [**]   None 19   [**]   [**] will be maintained by
Eisai until Epizyme assumes regulatory control of study.   Epizyme to reimburse
Eisai for invoiced costs from [**] prior to Epizyme’s assuming coverage
Estimated costs $[**] USD 20   [**]   Promptly after Epizyme assumes [**].  
None 21   [**]   Eisai will confirm version of [**] upon execution of the
Agreement and facilitate [**] within [**] days of Epizyme’s execution of CRO
contract.   None 22   [**]   [**] at least from execution of Agreement through
[**] and for an additional [**] days thereafter to allow Epizyme to [**].   None
23   [**]   Eisai will send [**] to Epizyme for review upon execution of the
Agreement and [**] will be sent by Eisai, with Epizyme contact copied, within
[**] days of execution of the Agreement. [**].   None

 

B-3

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

#

 

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

24   [**]   Upon execution of the Agreement and through Epizyme’s [**].   None
25   Word and pdf documents of the final:   Within [**] days of execution of the
Agreement   None 26   [**]   Within [**] days of execution of the Agreement  
None 27   [**]   Within [**] days of execution of the Agreement   None 28   [**]
  Within [**] days of execution of the Agreement   None 29   [**]   Within [**]
days of execution of the Agreement   None 30   [**]   within [**] days post
execution   None

 

B-4

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

   

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

  REGULATORY     31   [**]   Initiated after [**].   Epizyme will reimburse
Eisai internal costs of [**] FTE for Regulatory Support at rate of
$[**]USD/FTE/month for up to 3 months during transition (total estimated cost of
$[**]) as determined by Epizyme. 32   [**]   [**] will be performed by [**] and
[**] to be provided by [**]   Epizyme will reimburse Eisai internal costs for
Data Management Support at a rate of [**] FTE at $[**]USD/FTE/month, duration as
determined by Epizyme. 33   [**]   Within [**] days of execution of the
Agreement   None 34   [**]   Within [**] days of execution of the Agreement  
None None 35   [**]   Within [**] days of execution of the Agreement   None 36  
[**]   Within [**] days of execution of the Agreement   None 37   [**]   Within
[**] days of execution of the Agreement   None 38   Word and pdf documents of
the final:   Within [**] days of execution of the Agreement   39   [**]   Within
[**] days of execution of the Agreement   None 40   [**]   Within [**] days of
execution of the Agreement   None 41   [**]   Within [**] days of execution of
the Agreement   None 42   [**]   Within [**] days of execution of the Agreement
  None 43   [**]   Within [**] days of execution of the Agreement   None

 

B-5

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

   

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

  EPZ6438 CMC & MFG     44   [**]   Received on [**] with Epizyme’s approval and
confirmation within [**] days of execution of Agreement.   None 45   [**]  
Completed by [**] for shipment indicated below.   None 46   [**]   Within [**]
days of execution of Agreement   [**] USD/gm, plus any costs for shipping,
import tax, consumer tax, and VAT etc. 47   [**]   Received on [**] with
Epizyme’s approval and confirmation within [**] days of execution of Agreement.
  None 48   [**]   Received on [**] with Epizyme’s approval and confirmation
within [**] days of execution of Agreement.   None 49   [**]   Provided no later
than [**] days following date of execution of the agreement   Up to [**]
FTE-days for preparing summary at $[**]/day 50   [**]   Received on [**] with
Epizyme’s approval and confirmation within [**] days of execution of Agreement.
  None 51   [**]   Received on [**] with Epizyme’s approval and confirmation
within [**] days of execution of Agreement.   None 52   [**]   Provided no later
than the date of execution of Agreement. [**]   None 53   [**]   Documents
provided previously and receipt to be confirmed by Epizyme within [**] days of
execution of the Agreement.   None 54   [**]   Provided no later than [**] days
following date of execution of the agreement   None 55   [**]   Provided no
later than [**] days following date of execution of the agreement   None 56  
[**]   Provided no later than [**] days following date of execution of the
agreement   None 57   [**]   Received on [**] with Epizyme’s approval and
confirmation within [**] days of execution of Agreement.   None

 

B-6

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

   

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

58   [**]   Received on [**] with Epizyme’s approval and confirmation within
[**] days of execution of Agreement.   None 59   [**]   Shipped to Epizyme’s
designee within [**] days of confirmation of Epizyme designated recipient and
receipt of email request.   [**] USD (based on [**]gram of drug substance of
[**] USD/gram), plus any costs for shipping, import tax, consumer tax, and VAT
etc. 60   [**]   Shipped to Epizyme’s designee within [**] days of confirmation
of Epizyme designated recipient and receipt of email request.  

[**] g is available, [**] USD/gram, total [**] USD

 

Markers:

 

[**]

 

[**] USD/gram, total [**] USD

 

Plus any costs for shipping, import tax, consumer tax, and VAT etc.

61   [**]   No later than [**] days following execution of the Agreement,
pending identification of Epizyme’s designated recipient and pending government
approvals for shipment   [**]Plus any FTE for documentation, costs for shipping,
import tax, consumer tax, and VAT etc. 62   [**]   Shipped to [**]by[**] and
transfer ownership to Epizyme within [**] days of Epizyme’s execution of
contract with [**]   [**] USD, plus any costs for shipping, import tax, consumer
tax, and VAT etc. when the payment for tax is required by authorities. 63   [**]
  As agreed by [**]   Up to [**] FTE-days for preparing summary report at
$[**]/day. 64   [**]   Provided no later than [**]   None 65   [**]   Provided
no later than [**]   None 66   [**]   As agreed no later than [**] [**]   Up to
[**] FTE-days for preparing report at $[**]/day 67   [**]   Provided no later
than [**]   None 68   [**]   Provided no later than [**] days following date of
execution of the agreement   None 69   [**]   Provided no later than [**] days
following date of execution of the agreement   None 70   [**]   Provided no
later than [**] days following date of execution of the Agreement   None 71  
[**]   Shipped to Epizyme designee no later than [**]   $[**] USD (EXW)to be
invoiced under P.O. number to be provided by Epizyme

 

B-7

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

   

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

72   [**]   Shipped to Epizyme’s designee within [**] days of confirmation of
Epizyme designated recipient and receipt of email request with instructions.  
$[**]/gram based on actual amount available, plus any costs of shipping, import
tax, consumer tax, and VAT etc. 73   [**]   Shipped to Epizyme’s designee within
[**] days of confirmation of Epizyme designated recipient and receipt of email
request with instructions   [**] USD, plus any costs for shipping, import tax,
consumer tax, and VAT etc. 74   [**]   Ownership to be transferred upon [**]  
Epizyme will reimburse the cost of current [**] stocked in [**]. Tablet cost
$[**] USD, per quote [**]. [**] cost $[**] USD to be invoiced to Epizyme. 75  
[**]   No later than [**]   None 76   [**]   Received with [**] to be
acknowledged by Epizyme no later than [**] days following execution of the
Agreement   None 77   [**]   No later than [**]   None 78   [**]   No later than
[**]   Copy preparation to be invoiced at $[**]/day rate 79   [**]   Provided no
later than [**] days following date of execution of the Agreement   None 80  
[**]   No later than [**] days following execution of the Agreement   FTEs for
documentation for [**] days 81   [**]   Within [**] days of Epizyme’s request
following execution of the agreement but in no event later than [**] days
following execution of the Agreement.   [**]USD, plus any costs for shipping,
import tax, consumer tax, and VAT etc. 82   [**]   [**] after [**] for stability
study   [**] 83   [**]   Estimated delivery date of [**]   Pass through costs
for material to be invoiced in US dollars including Eisai tech transfer costs at
FTE rate of $[**]/day, subject to pre-approval by Epizyme of CMO cost, plus any
costs for shipping import tax, consumer tax and VAT. 84   [**]   [**]
(tentative)   Cost based on [**]. Eisai and Epizyme agreed to confirm the actual
estimated price by the [**]. 85   [**]   Starting [**] days after execution of
the Agreement until [**].   Epizyme will reimburse Eisai internal/external cost
for [**] based on Epizyme requests basis. Internal cost will be calculated using
$[**]/day.

 

[**]

 

B-8

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

   

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

86   [**]   Provided no later than [**] days following execution of the
Agreement   None   10961 CMC & MFG     87   [**]   Provided no later than [**]
days following date of execution of the Agreement   None 88   [**]   Provided no
later than [**] days following date of execution of the Agreement   None 89  
[**]   Provided no later than [**] days following date of execution of the
Agreement   None 90   [**]   Provided no later than [**] days following date of
execution of the Agreement   None 91   [**]   Provided no later than [**] days
following date of execution of the Agreement   None 92   [**]   Provided no
later than [**] days following date of execution of the Agreement   None 93  
[**]   Provided no later than [**] days following date of execution of the
Agreement   None 94   [**]   Provided no later than [**] days following date of
execution of the Agreement   None 95   [**]   Within [**] days of Epizyme’s
request following execution of the agreement but in no event later than [**]
days following execution of the Agreement.  

[**] USD (based on [**] g is available and [**]USD/gram), plus any

costs for shipping, import tax, consumer tax, and VAT etc.

96   [**]   Provided no later than [**] days following date of execution of the
Agreement   None 97   [**]   Provided no later than [**] days following date of
execution of the Agreement   None 98   [**]   Within [**]days following
execution of the Agreement   None 99   [**]   Within [**]days following
execution of the Agreement   None

 

B-9

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

   

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

100   [**]   Within [**]days following execution of the Agreement   None 101  
[**]   Within [**]days following execution of the Agreement   None 102   [**]  
Within [**]days following execution of the Agreement   None 103   [**]   Within
[**]days following execution of the Agreement, pending confirmation of Epizyme’s
designated recipient   [**] USD (based on [**]kg at [**]USD/gram), plus any
costs for shipping, import tax, consumer tax, and VAT etc. 104   [**]   Within
[**]days following execution of the Agreement   [**] USD/gram), plus any costs
for shipping, import tax, consumer tax, and VAT etc. 105   [**]   Within
[**]days following execution of the Agreement pending confirmation of Epizyme’s
designated recipient   [**] USD/gram), plus any costs for shipping, import tax,
consumer tax, and VAT etc. 106   [**]   Within [**]days following execution of
the Agreement-   [**]USD/gram), plus any costs for shipping, import tax,
consumer tax, and VAT etc.   [**]     107   [**]   Within [**] days of Agreement
execution   Copy preparation to be invoiced at $[**]/day rate 108   [**]  
Within [**] days of Agreement execution   None 109     Starting [**] days after
execution until Dec   Epizyme will reimburse Eisai internal/external cost for
[**] based on Epizyme requests basis. Internal cost will be calculated at $[**]
per day.

 

B-10

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

   

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

  PRECLINICAL BIOLOGY     110   [**]   Within [**] days of Agreement execution  
None   [**]       [**]       [**]       [**]       [**]       [**]       [**]  
    [**]       [**]       [**]       [**]       [**]     111   [**]   Within
[**] days of Agreement execution   $[**] for hard drive and shipping   [**]    
  [**]       [**]       [**]       [**]       [**]       [**]       [**]     112
  [**]   Within [**] days of Agreement execution   None   [**]       [**]      
[**]       [**]       [**]       [**]     113   [**]   Within [**] days of
Agreement execution   $[**] for dry ice shipping   [**]       [**]       [**]  
    [**]       [**]     114   [**]     shipping to be reimbursed   [**]   TBD  
  [**]   TBD     [**]   Within [**] days of Agreement execution     [**]  
Within [**] days of Agreement execution   115   [**]   Within [**] days of
Agreement execution   shipping to be reimbursed   [**]    

 

B-11

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

   

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

116   [**]     None   [**]     117   [**]   Within [**] days of Agreement
execution   shipping to be reimbursed   [**]       [**]     118   [**]   Within
[**] days of Agreement execution   $[**], for dry ice shipping   [**]       [**]
      [**]       [**]     119   [**]   Within [**] days of Agreement execution  
None   [**]     120   [**]     None   [**]     121   [**]   Within [**] days of
Agreement execution   None   [**]       NONCLINICAL DMPK-6438     122   [**]  
Within [**] days of Agreement execution   None 123   [**]   Within [**] days of
Agreement execution   None 124   [**]   Within [**] days of Agreement execution
  None   [**]   Within [**] days of Agreement execution   None   [**]   Within
[**] days of Agreement execution   None   [**]   Within [**] days of Agreement
execution   None 125   [**]   Within [**] days of Agreement execution   None 126
  [**]   Within [**] days of Agreement execution   None 127   [**]   Within [**]
days of Agreement execution   None 128   [**]   Within [**] days of Agreement
execution   None 129   [**]   Within [**] days of Agreement execution   None 130
  [**]   Within [**] days of Agreement execution   None

 

B-12

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

   

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

131   [**]   Within [**] days of Agreement execution   None 132   [**]   Within
[**] days of Agreement execution   None 133   [**]   Within [**] days of
Agreement execution   None 134   [**]   Within [**] days of Agreement execution
  None 135   [**]   Within [**] days of Agreement execution   None 136   [**]  
Within [**] days of Agreement execution   None 137   [**]   Within [**] days of
Agreement execution   None 138   [**]   Within [**] days of Agreement execution
  None 139   [**]   Within [**] days of Agreement execution   None 140   [**]  
Within [**] days of Agreement execution   None 141   [**]   Within [**] days of
Agreement execution   None 142   [**]   Within [**] days of Agreement execution
  None 143   [**]   Within [**] days of Agreement execution   None 144   [**]  
Within [**] days of Agreement execution   None 145   [**]   Within [**] days of
Agreement execution   None 146   [**]   Within [**] days of Agreement execution
  None 147   [**]   Within [**] days of Agreement execution   None 148   [**]  
Within [**] days of Agreement execution   None 149   [**]   Within [**] days of
Agreement execution   None 150   [**]   Within [**] days of Agreement execution
  None 151   [**]     152   [**]   Within [**] days of Agreement execution  
None 153   [**]   Within [**] days of Agreement execution   None 154   [**]  
Within [**] days of Agreement execution   None 155   [**]   Within [**] days of
Agreement execution   None 156   [**]   Within [**] days of Agreement execution
  None 157   [**]   Within [**] days of Agreement execution   None

 

B-13

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

   

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

158   [**]   Within [**] days of Agreement execution   None 159   [**]   Within
[**] days of Agreement execution   None 160   [**]   Within [**] days of
Agreement execution   None 161   [**]   Within [**] days of Agreement execution
  None 162   [**]   Within [**] days of Agreement execution   None 163   [**]  
Within [**] days of Agreement execution   None 164   [**]   Within [**] days of
Agreement execution   None 165   [**]   Within [**] days of Agreement execution
  None 166   [**]   Within [**] days of Agreement execution   None 167   [**]  
Within [**] days of Agreement execution   None 168   [**]   Within [**] days of
Agreement execution   None 169   [**]   Within [**] days of Agreement execution
  None 170   [**]   Within [**] days of Agreement execution   None 171   [**]  
Within [**] days of Agreement execution   None 172   [**]   Within [**] days of
Agreement execution   None 173   [**]   Within [**] days of Agreement execution
  None 174   [**]   Within [**] days of Agreement execution   None 175   [**]  
  176   [**]     177   [**]   within [**] days of Agreement execution   None 178
  [**]   within [**] days of Agreement execution   None 179   [**]   within [**]
days of Agreement execution   None 180   [**]   within [**] days of Agreement
execution   None 181   [**]   within [**] days of Agreement execution   None 182
  [**]   within [**] days of Agreement execution   None 183   [**]   within [**]
days of Agreement execution   None 184   [**]   within [**] days of Agreement
execution   None

 

B-14

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

   

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

185   [**]   within [**] days of Agreement execution   None 186   [**]   within
[**] days of Agreement execution   None 187   [**]   within [**] days of
Agreement execution   None 188   [**]   within [**] days of Agreement execution
  None 189   [**]   within [**] days of Agreement execution   None 190   [**]  
within [**] days of receipt of final study report from CRO   [**] 191   [**]  
within [**] days of Agreement execution   None 192   [**]   within [**] days of
Agreement execution   None 193   [**]   within [**] days of Agreement execution
  None 194   [**]   within [**] days of Agreement execution   None 195   [**]  
within [**] days of Agreement execution   None 196   [**]   within [**] days of
Agreement execution   None 197   [**]   within [**] days of Agreement execution
  None 198   [**]     199   [**]   within [**] days of execution of Agreement
and upon Epizyme’s request send to Epizyme designated archive site   shipping to
be reimbursed 200   [**]   within [**] days of execution of Agreement and upon
Epizyme’s request send to Epizyme designated archive site   shipping to be
reimbursed 201   [**]   within [**] days of execution of Agreement and upon
Epizyme’s request send to Epizyme designated archive site   shipping to be
reimbursed 202   [**]   within [**] days of execution of Agreement and upon
Epizyme’s request send to Epizyme designated archive site   shipping to be
reimbursed 203   [**]   within [**] days of execution of Agreement and upon
Epizyme’s request send to Epizyme designated archive site   shipping to be
reimbursed 204   [**]   within [**] days of execution of Agreement and upon
Epizyme’s request send to Epizyme designated archive site   shipping to be
reimbursed 205   [**]   within [**] days of execution of Agreement and upon
Epizyme’s request send to Epizyme designated archive site   shipping to be
reimbursed

 

B-15

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

   

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

206   [**]   within [**] days of execution of Agreement and upon Epizyme’s
request send to Epizyme designated archive site   shipping to be reimbursed 207
  [**]   within [**] days of execution of Agreement and upon Epizyme’s request
send to Epizyme designated archive site   shipping to be reimbursed 208   [**]  
within [**] days of execution of Agreement and upon Epizyme’s request send to
Epizyme designated archive site   shipping to be reimbursed 209   [**]   within
[**] days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site   shipping to be reimbursed 210   [**]   within [**]
days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site   shipping to be reimbursed 211   [**]   within [**]
days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site   shipping to be reimbursed 212   [**]     213   [**]  
within [**] days of execution of Agreement and upon Epizyme’s request send to
Epizyme designated archive site   shipping to be reimbursed 214   [**]   within
[**] days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site   shipping to be reimbursed 215   [**]   within [**]
days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site   shipping to be reimbursed 216   [**]   within [**]
days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site   shipping to be reimbursed 217   [**]   within [**]
days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site   shipping to be reimbursed

 

B-16

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

   

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

218   [**]   within [**] days of execution of Agreement and upon Epizyme’s
request send to Epizyme designated archive site   shipping to be reimbursed 219
  [**]   within [**] days of execution of Agreement and upon Epizyme’s request
send to Epizyme designated archive site   shipping to be reimbursed 220   [**]  
within [**] days of execution of Agreement and upon Epizyme’s request send to
Epizyme designated archive site   shipping to be reimbursed 221   [**]   within
[**] days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site   shipping to be reimbursed 222   [**]   within [**]
days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site archive site   shipping to be reimbursed 223   [**]  
within [**] days of execution of Agreement and upon Epizyme’s request send to
Epizyme designated archive site   shipping to be reimbursed 224   [**]   within
[**] days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site   shipping to be reimbursed 225   [**]     226   [**]  
within [**] days of execution of Agreement and upon Epizyme’s request send to
Epizyme designated archive site   shipping to be reimbursed 227   [**]   within
[**] days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site   shipping to be reimbursed 228   [**]   within [**]
days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site   shipping to be reimbursed 229   [**]   within [**]
days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site   shipping to be reimbursed 230   [**]   within [**]
days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site   shipping to be reimbursed 231   [**]   within [**]
days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site   shipping to be reimbursed

 

B-17

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

   

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

232   [**]   within [**] days of execution of Agreement and upon Epizyme’s
request send to Epizyme designated archive site   shipping to be reimbursed 233
  [**]   within [**] days of execution of Agreement and upon Epizyme’s request
send to Epizyme designated archive site   shipping to be reimbursed 234   [**]  
within [**] days of execution of Agreement and upon Epizyme’s request send to
Epizyme designated archive site archive site   shipping to be reimbursed 235  
[**]   within [**] days of execution of Agreement and upon Epizyme’s request
send to Epizyme designated archive site   shipping to be reimbursed 236   [**]  
within [**] days of execution of Agreement and upon Epizyme’s request send to
Epizyme designated archive site   shipping to be reimbursed 237   [**]   within
[**] days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site   shipping to be reimbursed 238   [**]   within [**]
days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site   shipping to be reimbursed 239   [**]   within [**]
days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site   shipping to be reimbursed 240   [**]   within [**]
days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site   shipping to be reimbursed 241   [**]   within [**]
days of execution of Agreement and upon Epizyme’s request send to Epizyme
designated archive site   shipping to be reimbursed 242   [**]     243   [**]  
within [**] days of execution of Agreement and upon Epizyme’s request send to
Epizyme designated archive site   None 244   [**]   within [**] days of
Agreement execution and upon Epizyme’s request send to Epizyme designated
archive site   None 245   [**]   within [**] days of Agreement execution   None
246   [**]   within [**] days of Agreement execution   None

 

B-18

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

   

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

247   [**]   within [**] days of Agreement execution   None 248   [**]   within
[**] days of Agreement execution   None 249   [**]   within [**] days of
Agreement execution and upon Epizyme’s request send to Epizyme designated
archive site   None 250   [**]   within [**] days of Agreement execution and
upon Epizyme’s request send to Epizyme designated archive site   None 251   [**]
    252   [**]   within [**] days of Agreement execution   None 253   [**]  
within [**] days of Agreement execution   None 254   [**]   within [**] days of
Agreement execution   shipping to be reimbursed 255   [**]   within [**] days of
Agreement execution   None 256   [**]   within [**] days of Agreement execution
  None 257   [**]   within [**] days of Agreement execution   None 258   [**]  
within [**] days of Agreement execution   None 259   [**]   within [**] days of
Agreement execution   shipping to be reimbursed 260   [**]   within [**] days of
Agreement execution   None 261   [**]   within [**] days of Agreement execution
  None 262   [**]   within [**] days of Agreement execution   shipping to be
reimbursed

 

B-19

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

263

 

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

264   [**]   [**] days following execution of Agreement   None 265  
Intentionally Blank   Intentionally Blank   Intentionally Blank 266  
Intentionally Blank   Intentionally Blank   Intentionally Blank

 

B-20

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

   

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

  TRANSLATIONAL MEDICINE     267   [**]     Epizyme will reimburse Eisai for
internal costs for performance of [**] at monthly FTE rate of $[**]
USD/FTE/month for up to [**] FTE and up to [**] months as determined by Epizyme.
Epizyme will reimburse Eisai up to [**] FTE for [**] months to complete [**].
Epizyme will reimburse up to $[**] USD for pass through costs associated with
[**]. 268   [**]     Epizyme will reimburse Eisai for internal costs for [**] at
monthly FTE rate of $[**] USD/FTE/month for up to [**][**] FTE and up to [**]
months as determined needed by Epizyme. Epizyme will reimburse Eisai up to [**]
FTE for [**] months to complete [**]. Epizyme will reimburse up to $[**] USD for
pass through costs associated with [**]. 269   [**]     270   [**]     271  
[**]     271   [**]   upon execution   Shipping to be reimbursed 273   [**]  
upon execution   Shipping to be reimbursed 274   [**]     275   [**]   upon
execution   Shipping to be reimbursed   [**]     276   [**]   upon execution  
Shipping to be reimbursed   [**]     277   [**]   upon execution   Shipping to
be reimbursed   [**]     278   [**]   upon execution   Shipping to be reimbursed
  [**]     279   [**]   upon execution   Shipping to be reimbursed   [**]    
280   [**]   within [**] days of Agreement execution   None 281   [**]   within
[**] days of Agreement execution   None 282   [**]   within [**] days of
Agreement execution   None

 

B-21

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

   

Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

283   [**]   within [**] days of Agreement execution   None 284   [**]   within
[**] days of Agreement execution   None   [**]       [**]     285   [**]  
within [**] days of Agreement execution   None 286   [**]   within [**] days of
Agreement execution   None   [**]     287   [**]   within [**] days of Agreement
execution   None 288   [**]   within [**] days of Agreement execution   None 290
  [**]   within [**] days of Agreement execution   None 291   [**]   within [**]
days of Agreement execution   None 292   [**]   within [**] days of Agreement
execution   None 293   [**]   within [**] days of Agreement execution   None 294
  [**]   within [**] days of Agreement execution   None 295   [**]   within [**]
days of Agreement execution   None   [**]     296   [**]   Upon Execution   None
297   [**]   within [**] days of Agreement execution   None   [**]     298  
[**]   Upon Execution   None 299   [**]   within [**] days of Agreement
execution   None   [**]     300   [**]   within [**] days of Agreement execution
  None   [**]     301   [**]   within [**] days of Agreement execution   None
302   [**]   within [**] days of Agreement execution   None 303   [**]   within
[**] days of Agreement execution   None 304   [**]   within [**] days of
Agreement execution   None 305   [**]   within [**] days of Agreement execution
  None

 

B-22

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Deliverable and Performance Requirement

 

Duration or Completion Deadline

 

Costs Associated

306   [**]   within [**] days of Agreement execution   None 307   [**]   within
[**] days of Agreement execution   None 308   [**]   within [**] days of
Agreement execution   None 309   [**]   within [**] days of Agreement execution
  None   [**]       [**]     310   [**]   upon execution   None 311   [**]  
upon execution   None 312   [**]   upon execution   None   [**]     313   [**]  
within [**] days of Agreement execution   None 314   [**]   within [**] days of
Agreement execution   None 315   [**]   within [**] days of Agreement execution
  None 316   [**]   within [**] days of Agreement execution   in clinical
database   [**]     317   [**]   upon execution   None 318   [**]   upon
execution   None 319   [**]   upon execution   None 320   [**]   within [**]
days of Agreement execution   None 321   [**]   within [**] days of Agreement
execution   None 322   [**]   within [**] days of Agreement execution   None 323
  [**]   within [**] days of Agreement execution   None 324   [**]   within [**]
days of Agreement execution   None 325   [**]   within [**] days of Agreement
execution   None 326   [**]   within [**] days of Agreement execution   None 327
  [**]   within [**] days of Agreement execution   None 328   [**]   within [**]
days of Agreement execution   None

Except as set forth below in the proviso, all liabilities to Third Parties
accrued by Eisai prior to the Restatement Date of the Agreement are borne by
Eisai.

To the extent Third Party liabilities are agreed to be assumed by Epizyme
herein, Epizyme is only responsible for liabilities accrued beginning on the
Restatement Date of the Agreement; provided, however, that any milestone based
payments [**] or scheduled payments based on regular timing intervals [**] which
have not become due and payable prior to the Restatement Date of the Agreement,
shall be borne solely by Epizyme.

 

B-23

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To the extent the Parties transfer materials between them in connection with any
transfer and transitional activities, the Parties shall document such transfers
in writing through customary material transfer documentation.

 

B-24

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EXHIBIT C-1

Epizyme Press Release

Epizyme Reacquires Global Rights from Eisai for First-in-Class EZH2 Inhibitor
EPZ-6438

— Epizyme obtains global operational responsibility and exclusive worldwide
commercial rights outside of Japan —

Cambridge, Mass., March 12, 2015 - Epizyme, Inc. (NASDAQ: EPZM), a clinical
stage biopharmaceutical company creating novel epigenetic therapeutics for
cancer patients, announced today that it has reacquired global rights to its
EZH2 program, including EPZ-6438 from its partner Eisai. Under the terms of the
agreement, Epizyme will be solely responsible for global clinical development,
manufacturing and commercialization in all countries outside of Japan, where
Eisai will retain rights. EPZ-6438, a first-in-class inhibitor of EZH2, is
currently being evaluated in a Phase 1/2 clinical study for the treatment of
B-cell non-Hodgkin lymphoma (NHL) and INI1-deficient solid tumors, such as
synovial sarcoma and malignant rhabdoid tumor.

“Over the past seven years, we have been deliberately building Epizyme as an
independent, fully integrated oncology company. Obtaining global control of
EPZ-6438, a very promising clinical asset, represents an important milestone in
the evolution of the Company,” said Robert Gould, Ph.D., President and Chief
Executive Officer, Epizyme. “As we began to see the quality and duration of the
responses, including two complete responses, in relapsed and refractory NHL and
INI1-deficient patients treated with EPZ-6438 as a monotherapy, it became clear
to us that having worldwide development and commercialization responsibility for
a targeted therapeutic like 6438 would be transformative for Epizyme.”

“With the continued emergence of clinical data on EPZ-6438, it is apparent that
this is a therapy with tremendous potential to benefit a variety of patient
populations,” said Takashi Owa, Ph.D., Chief Innovation Officer, Eisai Product
Creation Systems. “As we re-focus our resources on our later stage programs
across therapeutic areas, we believe that Epizyme is well positioned to move
EPZ-6438 development forward aggressively. We are pleased that the structure of
this agreement allows us to participate in the future success of EPZ-6438.”

Following completion of the transition of EPZ-6438 from Eisai to Epizyme,
Epizyme plans to conduct a five-arm Phase 2 study in approximately 150 patients
with non-Hodgkin lymphoma. This study will evaluate EPZ-6438 in the following
patient cohorts:

 

  •   Diffuse large B-cell lymphoma, germinal center B-cell-like (GCB) type with
wild-type EZH2

 

  •   Diffuse large B-cell lymphoma, GCB type with mutant EZH2

 

  •   Follicular lymphoma with wild-type EZH2

 

  •   Follicular lymphoma with mutant EZH2

 

  •   Diffuse large B-cell lymphoma, non-GCB type

 

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The cohort of patients with diffuse large B-cell non-GCB type is expected to
include predominantly patients with wild type EZH2, since the frequency of EZH2
mutations is approximately 5% in this sub-population of diffuse large B-cell
lymphoma.

In addition, Epizyme plans to initiate a Phase 2 study in adults with INI-1
deficient tumors, including synovial sarcoma, and a Phase 1 study in children
with INI-1 deficient tumors, including malignant rhabdoid tumors. Epizyme will
also continue the clinical pharmacology studies that are part of the Eisai /
Epizyme clinical plan.

“We are pleased to lead the development of EPZ-6438, and look forward to further
exploring and defining its clinical activity and safety in a range of
hematological and solid tumor indications,” said Peter Ho, M.D., Ph.D., Chief
Development Officer, Epizyme.

Terms of the Agreement

Under the terms of the agreement, Epizyme will be responsible for global
development, manufacturing and commercialization. Epizyme will fund 100 percent
of global development costs, and Eisai will fund 100 percent of Japan-specific
development costs.

Epizyme will make a $40 million upfront payment to Eisai, with a total of up to
$20 million in potential clinical milestone payments and up to $50 million in
potential regulatory milestone payments. Epizyme will pay Eisai a royalty at a
percentage in the mid-teens on sales of EPZ-6438 outside of Japan, and Eisai
will pay Epizyme a royalty at a percentage in the mid-teens on sales in Japan.
Eisai will have a limited right of first negotiation for Asia rights if Epizyme
decides to license Asia rights to a third party.

Conference Call Information

The Company will discuss details of this transaction and the Company’s
development plans for EPZ-6438 on its 2014 financial results conference call, to
be held at 7:30 a.m. today, March 12.

To participate in the conference call, please dial 1-877-844-6886 (domestic) or
1-970-315-0315 (international) and refer to conference ID 1428077. The live
webcast can be accessed under “Events and Presentations” in the Investor
Relations section of the Company’s website at www.epizyme.com.

About EPZ-6438

Epizyme is developing EPZ-6438 for the treatment of non-Hodgkin lymphoma
patients and patients with INI1-deficient solid tumors. EPZ-6438 is a small
molecule inhibitor of EZH2 developed by Epizyme. In many human cancers,
misregulated EZH2 enzyme activity results in misregulation of genes that control
cell proliferation—without these control mechanisms, cancer cells are free to
grow rapidly.

EPZ-6438 is the second HMTi to enter human clinical development (following
Epizyme’s DOT1L inhibitor, EPZ-5676).

Additional information about this program, including clinical trial information,
may be found here:
http://clinicaltrials.gov/ct2/show/NCT01897571?term=7438&rank=1

About Epizyme, Inc.

Epizyme, Inc. is a clinical stage biopharmaceutical company creating novel
epigenetic therapeutics for cancer patients. Epizyme has built a proprietary
product platform that the company uses to create small molecule inhibitors of a
96-member class of enzymes known as

 

C-2

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histone methyltransferases, or HMTs. HMTs are part of the system of gene
regulation, referred to as epigenetics, that controls gene expression. Genetic
alterations can result in changes to the activity of HMTs, making them oncogenic
(cancer-causing). By focusing on the genetic drivers of cancers, Epizyme’s
targeted science seeks to match the right medicines with the right patients.

For more information, visit www.epizyme.com and connect with us on Twitter
at @EpizymeRx.

Cautionary Note on Forward-Looking Statements

Any statements in this press release about future expectations, plans and
prospects for Epizyme, Inc. and other statements containing the words
“anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,”
“continue,” and similar expressions, constitute forward-looking statements
within the meaning of The Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important factors, including:
uncertainties inherent in the initiation of future clinical studies or expansion
of ongoing clinical studies, availability and timing of data from ongoing
clinical studies, whether interim results from a clinical trial will be
predictive of the final results of the trial or the results of future trials,
expectations for regulatory approvals, development progress of the Company’s
companion diagnostics, availability of funding sufficient for the Company’s
foreseeable and unforeseeable operating expenses and capital expenditure
requirements, other matters that could affect the availability or commercial
potential of the Company’s therapeutic candidates or companion diagnostics and
other factors discussed in the “Risk Factors” section of the Company’s Annual
Report on Form 10-K for the year ended December 31, 2014, that will be filed
with the Securities and Exchange Commission. In addition, the forward-looking
statements included in this press release represent the Company’s views as of
the date hereof. The Company anticipates that subsequent events and developments
will cause the Company’s views to change. However, while the Company may elect
to update these forward-looking statements at some point in the future, the
Company specifically disclaims any obligation to do so. These forward-looking
statements should not be relied upon as representing the Company’s views as of
any date subsequent to the date hereof.

Media/Investors:

Manisha Pai

Epizyme, Inc.

617.229.7560

mpai@epizyme.com

 

C-3

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EXHIBIT C-2

 

No. 15-19 Eisai Press Release March 12, 2015 Eisai Co., Ltd.

STATEMENT REGARDING CHANGES TO STRATEGIC PARTNERSHIP WITH

EPIZYME, INC. TO DISCOVER, DEVELOP AND COMMERCIALIZE

ANTICANCER THERAPIES TARGETING EZH2 EPIGENETIC ENZYME

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today
that Eisai and Epizyme, Inc. (Headquarters: Cambridge, Massachusetts, CEO:
Robert Gould, Ph.D., “Epizyme”) have agreed to change the scope of collaboration
for their worldwide partnership initiated in March 2011 to discover, develop and
commercialize cancer therapeutics targeting EZH2, an epigenetic enzyme.

In March 2011, Eisai and Epizyme entered into a collaboration agreement
concerning the discovery, development and commercialization of cancer
therapeutics targeting the epigenetic enzyme EZH2 for the treatment of
non-Hodgkin B-cell lymphoma and other cancers. Under this agreement, Eisai has
been conducting a Phase I/II clinical study of the EZH2 inhibitor E7438 (Epizyme
development code: EPZ-6438) in patients with advanced solid tumors or
non-Hodgkin B-cell lymphoma.

Eisai and Epizyme have revised the scope of their partnership for worldwide
development and commercialization rights for anticancer therapies targeting
EZH2, including E7438, with Epizyme assuming responsibility for development and
commercialization in regions outside of Japan and Eisai retaining responsibility
for development and commercialization within Japan as well as having the right
of first negotiation for licensing rights in Asia. The decision to change the
scope of the partnership was agreed upon by the two companies in consideration
of the priorities of each company’s pipeline strategy and the maximization of
the potential value of the compounds including E7438.

Based on this change in the agreement, Eisai will receive from Epizyme a
contractual one-time payment as well as milestone payments as projects progress
and marketing authorization is obtained. The companies will pay royalties to one
another dependent upon on the sales in each company’s respective sales regions
after launch.

Eisai considers oncology a therapeutic area of focus and is committed to the
development of new anticancer agents and treatments for supportive care. Eisai
strives to further contribute to addressing the diverse needs of, and increasing
the benefits provided to, patients with cancer and their families.

 

C-4

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Media Inquiries:

Public Relations Department,

Eisai Co., Ltd.

+81-(0)3-3817-5120

[Notes to editors]

 

1. About Epizyme Inc.

Epizyme, Inc. is a clinical stage biopharmaceutical company that discovers,
develops and plans to commercialize novel epigenetic therapies for cancer
patients. Epizyme has built a proprietary product platform that the Company uses
to create small molecule inhibitors of enzymes known as histone
methyltransferases, or HMTs. HMTs are part of the system of gene regulation,
referred to as epigenetics, that controls gene expression. Genetic alterations
can result in changes to the activity of HMTs, making them oncogenic
(cancer-causing). By focusing on the genetic drivers of cancers, Epizyme’s
targeted science seeks to match the right medicines with the right patients for
a personalized approach to cancer treatment. For more information, visit
www.epizyme.com.

 

2. About EZH2

EZH2 is one of the proteins that make up the histone methyltransferases (HMTs)
that alter gene expression. EZH2 is known to methylate lysine 27 of the protein
H3 (H3K27), H3 being one of the five major histone groups (H1, H2A, H2B, H3 and
H4) that together help to store DNA in eukaryotic cell nuclei. H3K27 methylation
is also known to suppress gene transcription. It is believed that EZH2 regulates
cell proliferation, and may have an important role in carcinogenesis. Also,
deletion of the INI1 subunit SWI/SNF chromatin-remodeling complex occurs in
nearly all malignant rhabdoid tumors (MRT), a rare cancer, but with a
particularly poor prognosis. An antagonistic relationship has been demonstrated
between the biochemical action of the SWI/SNF complex and EZH2 on chromatin,
which is relieved in MRT due to the INI1 deletion. EZH2 may be a potential
driving oncogene in these cancers and therefore an important therapeutic target
requiring further investigation. Created through Epizyme’s proprietary product
platform, E7438 (EPZ-6438) is a first-in-class selective small molecule
inhibitor of the epigenetic enzyme EZH2. Eisai and Epizyme initiated a global
strategic partnership in March 2011 regarding the research, development and
marketing of EZH2 targeted therapies for lymphomas and other cancers influenced
by these genetic alterations.

 

C-5

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EXHIBIT D

Asia

Bahrain, Bangladesh, Bhutan, Burma, Cambodia, China, Hong Kong, Indonesia, South
Korea, Laos, Phillipines, Malaysia, Maldives, Mongolia, Nepal, Singapore, Sri
Lanka, Taiwan, Thailand, Timor-Leste, and Vietnam.