Exhbit 10.39

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

COLLABORATION AGREEMENT

between

BOEHRINGER INGELHEIM INTERNATIONAL GmbH

and

EPIZYME, INC.

Dated as of Wednesday November 14, 2018

 

BII Contract Number [**]

 

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TABLE OF CONTENTS

Page

ARTICLE 1 Definitions

1

ARTICLE 2 Collaboration Management

27

2.1.

Joint Steering Committee

27

2.2.

General Provisions Applicable to Joint Committees

30

2.3.

Interactions Between JSC and Internal Teams

32

2.4.

Working Groups

32

2.5.

Expenses

32

ARTICLE 3 Research Plan; Research Period

33

3.1.

Research Plan

33

3.2.

Research Period

33

3.3.

Amendments to the Research Plan

34

ARTICLE 4 Research Program

34

4.1.

Prior to SoLO

34

4.2.

Following SoLO but Prior to SoD

36

4.3.

Materials, Compound Transfer, and Customs Related Topics

37

4.4.

Exclusivity

39

ARTICLE 5 Post-Research Responsibilities

40

5.1.

BII Controlled Project

40

5.2.

Jointly Controlled Project

41

5.3.

Manufacturing; Technology Transfer

50

5.4.

Recalls

50

ARTICLE 6 Grant of Rights

51

6.1.

Grant to Epizyme

51

6.2.

Grant to BII

51

6.3.

Negative Covenant

52

6.4.

Sublicenses

52

6.5.

Subcontracting

52

6.6.

Retention of Rights

52

6.7.

Recordation

52

ARTICLE 7 Payments and Records

53

7.1.

Upfront Payment

53

7.2.

Research Funding

53

7.3.

Milestone Payments

54

7.4.

Royalties

55

7.5.

Royalty Payments and Reports

56

7.6.

Mode of Payment; Offsets

57

7.7.

Taxes; Withholding Taxes

57

7.8.

Interest on Late Payments

58

7.9.

Financial and Other Records

58

7.10.

Audit; Audit Dispute

58

7.11.

Confidentiality

59

ARTICLE 8 Intellectual Property

59

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TABLE OF CONTENTS

(cont’d)

Page

8.1.

Ownership of Intellectual Property

59

8.2.

Maintenance and Prosecution of Patents

61

8.3.

Enforcement of Patents

63

8.4.

Infringement Claims by Third Parties

69

8.5.

Invalidity or Unenforceability Defenses or Actions.

70

8.6.

Third Party Licenses

71

8.7.

Product Marks

71

8.8.

Inventor’s Remuneration

72

ARTICLE 9 Pharmacovigilance and Safety

72

9.1.

Pharmacovigilance

72

9.2.

Global Safety Database

72

ARTICLE 10 Confidentiality and Non-Disclosure

73

10.1.

Confidentiality Obligations

73

10.2.

Permitted Disclosures

74

10.3.

Use of Name

75

10.4.

Press Releases

76

10.5

Agreement Redactions

76

10.6.

Publications

76

10.7.

Confidentiality Redaction

77

10.8.

Survival

77

ARTICLE 11 Representations and Warranties

78

11.1.

Mutual Representations and Warranties

78

11.2.

Additional Representations and Warranties of Epizyme

79

11.3.

Mutual Covenants

79

11.4.

DISCLAIMER OF WARRANTIES

80

ARTICLE 12 Indemnity

80

12.1.

Indemnification of Epizyme

80

12.2.

Indemnification of BII

80

12.3.

Procedure

81

12.4.

No Consequential Damages

81

12.5.

Insurance

81

ARTICLE 13 Term and Termination

82

13.1.

Term

82

13.2.

Termination

82

13.3.

Effects of Termination

84

13.4.

Effects of Expiration and Termination

92

13.5.

Remedies

92

13.6.

Survival

92

ARTICLE 14 Miscellaneous

93

14.1.

Force Majeure

93

14.2.

Change in Control

93

14.3.

Export Control

94

14.4.

Assignment

94

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TABLE OF CONTENTS

(cont’d)

Page

14.5.

Severability

95

14.6.

Governing Law; Service

95

14.7.

Dispute Resolution

95

14.8.

Notices

97

14.9.

Entire Agreement; Amendments

98

14.10.

English Language

98

14.11.

Equitable Relief

98

14.12.

Waiver and Non-Exclusion of Remedies

98

14.13.

No Benefit to Third Parties

98

14.14.

Further Assurance

98

14.15.

Relationship of the Parties

99

14.16.

Counterparts; Execution

99

14.17.

References

99

14.18.

Construction

99

 

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TABLE OF CONTENTS

(cont’d)

Page

SCHEDULES

Schedule 1.40Compound Criteria

Schedule 1.48[**] Competing Product Criteria

Schedule 1.81FTE Rate

Schedule 1.97Invoicing Requirements

Schedule 1.156 Research Plan (Including SoLO Criteria and SoD Criteria)

Schedule 1.164[**] Competing Product Criteria

Schedule 10.4Press Release

Schedule 13.3Special Arbitration

 

 

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COLLABORATION AGREEMENT

This Collaboration Agreement (this “Agreement”) is made and entered into as of
Wednesday November 14, 2018 (the “Effective Date”) by and between Boehringer
Ingelheim International GmbH, a German corporation, with its principal place of
business at Binger Strasse 173, 55216 Ingelheim am Rhein, Germany (“BII”), and
Epizyme, Inc., a Delaware corporation, with its principal place of business at
400 Technology Square, 4th Floor, Cambridge, Massachusetts 02139, USA
(“Epizyme”). BII and Epizyme may each be referred to herein as a “Party” and,
collectively, as the “Parties.”

RECITALS

WHEREAS, BII is a global pharmaceutical company with experience in the research,
development, manufacture and commercialization of pharmaceutical products;

WHEREAS, Epizyme is a clinical stage biopharmaceutical company engaged in the
research, development and manufacture of novel epigenetic medicines for patients
with cancer and other diseases; and

WHEREAS, subject to the terms and conditions of this Agreement, BII and Epizyme
now desire to collaborate with respect to researching and developing small
molecule compounds that are inhibitors of the [**] (a histone acetyl
transferase) and [**] (a helicase) targets, along with associated predictive
biomarkers therefor, and commercializing products containing such compounds.

NOW, THEREFORE, in consideration of the premises and the mutual promises and
conditions hereinafter set forth, and other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the Parties, intending
to be legally bound, do hereby agree as follows:

ARTICLE 1
Definitions

Unless otherwise specifically provided herein, the following terms will have the
following meanings:

1.1“Additional Cure Period” has the meaning set forth in Section 13.2.1
(Termination of Agreement for Cause).

1.2“Affiliate” means, with respect to a Party, any Person that, directly or
indirectly, through one or more intermediaries, controls, is controlled by or is
under common control with such Party. For purposes of this definition, “control”
and, with correlative meanings, the terms “controlled by” and “under common
control with” means: (a) the possession, directly or indirectly, of the power to
direct the management or policies of a Person, whether through the ownership of
voting securities, by contract relating to voting rights or corporate
governance, or otherwise; or (b) the ownership, directly or indirectly, of at
least fifty percent (50%) of the voting securities or other ownership interest
of a Person (or, with respect to a limited partnership or other similar entity,
its general partner or controlling entity). The Parties acknowledge that in the

 

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case of certain entities organized under the laws of certain countries outside
of the United States, the maximum percentage ownership permitted by law for a
foreign investor may be less than fifty percent (50%), and that in such case
such lower percentage will be substituted in the preceding sentence; provided
that such foreign investor has the power to direct the management or policies of
such entity.

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

1.4“Alliance Manager” has the meaning set forth in Section 2.2.4 (Alliance
Manager).

1.5“Allowable Expenses” means the following expenses that are specifically
identifiable and directly attributable to the Commercialization of Joint
Products in the United States:

1.5.1Sales and Marketing Costs;

1.5.2Distribution Costs;

1.5.3Manufacturing Costs;

1.5.4Medical Affairs Costs, including (for clarity) Phase IV Costs;

1.5.5Patient Assistance Program Costs;

 

1.5.6

Third Party Payments, including the appropriate allocable portion of upfront
payments;

1.5.7Diagnostic Third Party Payments;

1.5.8Trademark Costs;

1.5.9Recall Costs;

1.5.10Product Liability Costs; and

1.5.11Product Insurance Costs.

1.6“ANDA Act” has the meaning set forth in Section 8.3.5 (Generic Competition).

1.7“Applicable Law” means federal, state, local, national and supra-national
laws, statutes, rules and regulations, including any rules, regulations,
regulatory guidelines or other requirements of the Regulatory Authorities, major
national securities exchanges or major securities listing organizations, that
may be in effect from time to time during the Term and applicable to a
particular activity or country hereunder.

1.8“ArbnErfG” has the meaning set forth in Section 8.1.6 (German Statute).

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1.9“Bankruptcy Code” has the meaning set forth in Section 13.2.5 (Termination
for Insolvency).

1.10“BII” has the meaning set forth in the Preamble.

1.11“BII Compound” has the meaning set forth in Section 5.1.1 (BII Products
Report).

1.12“BII Controlled Project” means the Target Project directed to the [**]
target.

1.13“BII Indemnitees” has the meaning set forth in Section 12.2 (Indemnification
of BII).

1.14“BII Know-How” means all Information that is: (a) Controlled by BII or any
of its Affiliates on the Effective Date or during the Term, (b) not generally
known, (c) reasonably necessary or useful for performing Research Activities or
for the Development, Manufacture or Commercialization of a Compound, Product or
Diagnostic Product and (d) arose from or was actually applied in (i) the
performance of Research Activities or (ii) the Development, Manufacture or
Commercialization of a Compound, Product or Diagnostic Product, but excluding
any Information comprising Joint Know-How.

1.15“BII Patents” means all of the Patents that: (a) are Controlled by BII or
any of its Affiliates on the Effective Date or during the Term, (b) Covers
subject matter that is reasonably necessary or useful (or, with respect to
patent applications, would be reasonably necessary or useful if such patent
applications were to issue as patents) for performing Research Activities or for
the Development, Manufacture or Commercialization of a Compound, Product or
Diagnostic Product and (c) arose from or was actually applied in (i) the
performance of Research Activities or (ii) the Development, Manufacture or
Commercialization of a Compound, Product or a Diagnostic Product, but excluding
any Joint Patents.

1.16“BII Product” has the meaning set forth in Section 5.1.1 (BII Products
Report).

1.17“BII Product Infringement” has the meaning set forth in Section 8.3.3
(Enforcement of BII Patents).

1.18“BII Product Patents” has the meaning set forth in Section 8.2.3 (BII
Patents).

1.19“BII Product Prosecuted Infringements” has the meaning set forth in Section
8.3.3 (Enforcement of BII Patents).

1.20“BII Products Report” has the meaning set forth in Section 5.1.1 (BII
Products Report).

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1.21“BII Research Compounds” means all compounds that are identified by BII and
arising under this Agreement, including any modifications, variations or
derivatives thereof, including any metabolite, salt, ester, hydrate, solvate,
isomer, enantiomer, free acid form, free base form, crystalline form,
co-crystalline form, amorphous form, pro-drug (including ester pro-drug) form,
racemate, polymorph, chelate, stereoisomer, tautomer, optically active form or
any derivatives; provided that, following cross-screening of such compounds by
BII or by Epizyme in accordance with the Research Plan using its helicase or
histone acetyl transferase cross-screening panels, BII will have the right to
exclude up to [**] Compounds that are shown through such cross-screening to be
[**] inhibitors and up to [**] Compounds that are shown through such
cross-screening to be [**] inhibitors from the definition of BII Research
Compounds upon written notice to Epizyme (such written notices, collectively,
the “Excluded Compound List”); provided further that BII may periodically update
the Excluded Compound List with other Compounds upon written notice to Epizyme
(but in no event may the Excluded Compound List identify more than [**]
inhibitors and [**] inhibitors at any time) and, upon each such update (i)
Compounds that were previously included in the Excluded Compound List but that
BII removes from the Excluded Compound List, shall be deemed to be BII Research
Compounds and (ii) Compounds that were not previously included in the Excluded
Compound List but that BII adds to the Excluded Compound List, shall be excluded
from the definition of BII Research Compounds.

1.22“BII SoD Committee” has the meaning set forth in Section 4.2.2(a)
(Satisfaction of SoD Criteria).

1.23“BII SoLO Committee” has the meaning set forth in Section 4.1.2(a)
(Satisfaction of SoLO Criteria).

1.24“BII Technology” means, collectively, the BII Know-How and BII Patents.

1.25“Board of Directors” has the meaning set forth in the definition of “Change
in Control.”

1.26“Business Day” means a day other than a Saturday or Sunday on which banking
institutions in Boston, Massachusetts and Ingelheim am Rhein, Germany are open
for business.

1.27“Calendar Quarter” means each successive period of three (3) calendar months
commencing on January 1, April 1, July 1 and October 1, except that the first
Calendar Quarter of the Term will commence on the Effective Date and end on the
day immediately prior to the first to occur of January 1, April 1, July 1 or
October 1 after the Effective Date, and the last Calendar Quarter will end on
the last day of the Term.

1.28“Calendar Year” means each successive period of twelve (12) calendar months
commencing on January 1 and ending on December 31, except that the first
Calendar Year of the Term will commence on the Effective Date and end on
December 31 of the year in which the Effective Date occurs, and the last
Calendar Year of the Term will commence on January 1 of the year in which the
Term ends and end on the last day of the Term.

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1.29“Centralized Approval Procedure” means the procedure through which a MAA
filed with the EMA results in a single marketing authorization valid throughout
the European Union.

1.30“Change in Control” means, with respect to a Party, the occurrence of any of
the following after the Effective Date:

1.30.1any “person” or “group” (as such terms are defined below): (a) is or
becomes the “beneficial owner” (as defined below), directly or indirectly, of
shares of capital stock or other interests (including partnership interests) of
such Party then outstanding and normally entitled (without regard to the
occurrence of any contingency) to vote in the election of the directors,
managers or similar supervisory positions (“Voting Stock”) of such Party
representing fifty percent (50%) or more of the total voting power of all
outstanding classes of Voting Stock of such Party; or (b) has the power,
directly or indirectly, to elect a majority of the members of the Party’s board
of directors, or similar governing body (“Board of Directors”); or

1.30.2such Party enters into a merger, consolidation or similar transaction with
another Person (whether or not such Party is the surviving entity) and as a
result of such merger, consolidation or similar transaction (a) the members of
the Board of Directors of such Party immediately prior to such transaction
constitute less than a majority of the members of the Board of Directors of such
Party or such surviving Person immediately following such transaction; or
(b) the Persons that beneficially owned, directly or indirectly, the shares of
Voting Stock of such Party immediately prior to such transaction cease to
beneficially own, directly or indirectly, shares of Voting Stock of such Party
representing at least a majority of the total voting power of all outstanding
classes of Voting Stock of the surviving Person in substantially the same
proportions as their ownership of Voting Stock of such Party immediately prior
to such transaction; or

1.30.3such Party sells or transfers to any Third Party, in one or more related
transactions, properties or assets representing all or substantially all of such
Party’s consolidated total assets to which this Agreement relates; or

1.30.4the holders of capital stock of such Party approve a plan or proposal for
the liquidation or dissolution of such Party.

For the purpose of this definition of “Change in Control,” (a) “person” and
“group” have the meanings given such terms under Section 13(d) and 14(d) of the
United States Securities Exchange Act of 1934 and the term “group” includes any
group acting for the purpose of acquiring, holding or disposing of securities
within the meaning of Rule 13d-5(b)(1) under the said Act; (b) a “beneficial
owner” will be determined in accordance with Rule 13d-3 under the aforesaid Act;
and (c) the terms “beneficially owned” and “beneficially own” will have meanings
correlative to that of “beneficial owner.”

1.31“Clinical Trials” means, collectively, First In-Human Clinical Trials,
Non-Pivotal Clinical Trials and Pivotal Clinical Trials, and such other tests
and studies in human subjects or patients that are required by Applicable Law,
or otherwise recommended by the Regulatory Authorities, to obtain or maintain
Regulatory Approvals for a Product for one or

-5-

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more Indications, including tests or studies that are intended to expand the
Product Labeling for such Product with respect to one or more such Indications
or are otherwise deemed useful with respect to the continued Development of a
Compound and/or Product. For clarity, Phase IV Studies are not part of Clinical
Trials.

1.32“Collaboration Technology” means, collectively, the BII Technology, the
Epizyme Technology and the Joint Technology.

1.33“Combination Product” means a Product that is sold in the form of a
combination product, whether in a fixed dose combination or in the same
packaging, containing both a Compound and one or more independently
therapeutically active pharmaceutical or biologic products.

1.34“Commercialization” means any and all activities directed to the preparation
for sale of, offering for sale of or sale of a Product, including activities
related to marketing, promoting, distributing, importing and exporting such
Product, and interacting with Regulatory Authorities regarding any of the
foregoing, and in all cases, which do not constitute Development activities.
When used as a verb, “to Commercialize” and “Commercializing” means to engage in
Commercialization, and “Commercialized” has a corresponding meaning.

1.35“Commercialization Overrun” has the meaning set forth in Section
5.2.2(c)(iv) (Commercialization Overruns).

1.36“Commercially Reasonable Efforts” means, with respect to the performance of
Development and Commercialization activities with respect to any Compound,
Product or Diagnostic Product by a Party, the carrying out of such activities in
a sustained manner using efforts and resources, in good faith, consistent with
reasonable practices and expended in a manner and timing consistent with the
exercise of prudent scientific and business judgment that a similarly situated
company within the biopharmaceutical or pharmaceutical industry, as the case may
be, would reasonably devote in a given market for the development and
commercialization of a pharmaceutical product having similar market potential as
a particular Compound, Product or Diagnostic Product at a similar stage in
development or product life, taking into account all scientific, commercial, and
other factors that such company would take into account, including issues of
safety and efficacy, expected and actual cost and time to develop, expected and
actual profitability, expected and actual competitiveness of alternative
products [**] (including generic or biosimilar products)), the nature and extent
of expected and actual market exclusivity (including Patent coverage and
regulatory exclusivity), the expected likelihood of Regulatory Approval, the
expected and actual reimbursability and pricing, and the expected and actual
amounts of marketing and promotional expenditures required.

1.37“Committed Costs” means, with respect to the Joint Product, (a) (i) the next
[**] of expenses not yet incurred, as set forth in the firm budget portion of
the then-current Joint Development Plan and Budget or Joint Commercialization
Plan and Budget for such Joint Product or (ii) if less than [**] remain with
respect to the firm budget portion of the then-current Joint Development Plan
and Budget or Joint Commercialization Plan and Budget for such Joint Product,
the expenses not yet incurred and associated with the months remaining in the
firm budget portion of the then-current Joint Development Plan and Budget or
Joint

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Commercialization Plan and Budget for such Joint Product and (b) [**] costs
associated with Clinical Trials for the Joint Product that have been Initiated
as of the effective date of the termination of this Agreement or date of the
Epizyme Opt-Out Notice with respect to such Joint Product.

1.38“Companion Diagnostic Product” means a medical device, often an in vitro
device (IVD), that provides Information that is essential for the safe and
effective use of a Compound or Product.

1.39“Complementary Diagnostic Product” means a test that aids in the
benefit-risk decision-making about the use of a Compound or Product, where the
difference in benefit-risk is clinically meaningful.

1.40“Compound” means, with respect to each Target Project, all small molecule
[**] inhibitors and [**] inhibitors that meet the criteria set forth on Schedule
1.40 and are (a) Controlled by Epizyme as of the Effective Date of this
Agreement or (b) Controlled by Epizyme or BII following the Effective Date and
discovered or identified by or on behalf of a Party in performing its activities
under this Agreement or, with respect to (a)-(b), (i) any modifications,
variations or derivatives thereof that meet the criteria set forth on Schedule
1.40 or (ii) regardless of whether they meet the criteria set forth on Schedule
1.40 (A) any salt, ester, hydrate, solvate, enantiomer, free acid form, free
base form, crystalline form, co-crystalline form, amorphous form, pro-drug
(including ester pro-drug) form, racemate, polymorph, chelate, tautomer or
optically active form thereof or (B) any metabolite, isomer, stereoisomer or
isotopic derivatives thereof that are useful for Development and, with respect
to each of the foregoing (i)-(ii), that are discovered identified or created by
or on behalf of a Party during the Term; provided that any [**] inhibitor or
[**] inhibitor that achieves SoLO Approval or SoD Approval shall be considered a
Compound irrespective of whether such [**] inhibitor or [**] inhibitor meets the
criteria set forth on Schedule 1.40.

1.41“Conduct” means, with respect to any Clinical Trial, to (a) sponsor, support
or perform, directly or indirectly through a Third Party, such Clinical Trial;
or (b) provide to a Third Party funding for, or clinical supplies (including
placebo (to the extent required by Clinical Trial design)) for use in, such
Clinical Trial.

1.42“Confidential Information” means any Information or data provided orally,
visually, in writing or other form by or on behalf of one Party (or an Affiliate
or representative of such Party) to the other Party (or to an Affiliate or
representative of such Party) in connection with this Agreement, whether prior
to, on or after the Effective Date, including Information relating to the terms
of this Agreement, any Compound, Product or Diagnostic Product, any Exploitation
of any Compound, Product or Diagnostic Product, any know-how with respect
thereto developed by or on behalf of the disclosing Party or its Affiliates or
the scientific, regulatory or business affairs or other activities of either
Party.

1.43“Contractor” means a Third Party to whom a Party has subcontracted any of
its activities under this Agreement pursuant to Section 6.5 (Subcontracting).

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1.44“Control” means, with respect to any item of Information, material, Patent
or other property right, the possession of the right, whether directly or
indirectly, and whether by ownership, license, covenant not to sue or otherwise,
to grant a license, sublicense or other right to or under such Information,
material, Patent or other property right as provided for herein without
violating the terms of any agreement or other arrangement with any Third Party.
Notwithstanding the foregoing, a Party and its Affiliates will not be deemed to
“Control” any item of Information, material, Patent or other property right
that, prior to or following the consummation of a Change in Control of such
Party, is owned or in-licensed by a Third Party that becomes an Affiliate of
such acquired Party after the Effective Date as a result of such Change in
Control unless (a) prior to the consummation of such Change in Control, such
acquired Party or any of its Affiliates also Controlled such item of
Information, material, Patent or other property right or (b) the item of
Information, material, Patent or other property right owned or in-licensed by
the applicable Third Party were not used in the performance of activities under
this Agreement prior to the consummation of such Change in Control, but after
the consummation of such Change in Control, such acquired Party or any of its
Affiliates determines to use or uses any such item of Information, material,
Patent or other property right in the performance of its obligations or exercise
of its rights under this Agreement, in each of which cases ((a) and (b)), such
item of Information, material, Patent or other property right will be
“Controlled” by such Party for purposes of this Agreement.

1.45“Counter Screen” means an enzymatic or cellular assay used to determine the
activity of a compound as an inhibitor or activator of helicase or histone
acetyl transferase activity.

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

1.47“[**]” means [**].

1.48“[**]” means [**].

1.49“Defaulting Party” has the meaning set forth in Section 13.2.1 (Termination
of Agreement for Cause).

1.50“Detail” means, with respect to a Joint Product in the United States, a
face-to-face or virtual/digital contact between a sales representative and a
physician or other medical professional licensed to prescribe drugs, during
which a primary position detail or a secondary position detail is made to such
Person, in each case, as measured by each Party’s internal recording of such
activity and always consistent with then-current Joint Commercialization Plan
and Budget; provided that such meeting is consistent with and in accordance with
the requirements of Applicable Law, the PhRMA Code on Interactions with
Healthcare Professionals and this Agreement. When used as a verb, “Detail” or
“Detailing” means to engage in a Detail. For clarity, Detail shall exclude
discussions at conventions, trade shows and similar forums or meetings.

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1.51“Detail Costs” means those costs incurred in accordance with the Joint
Commercialization Plan and Budget and specifically identifiable and directly
attributable to Detailing the Joint Product in the United States, which shall be
determined in accordance with Section 5.2.2(c)(ii) (FTE Records and
Calculation).

1.52“Development” means all activities related to research, pre-clinical and
other non-clinical testing, test method development and stability testing,
toxicology, formulation, process development, Manufacturing scale-up,
qualification and validation, quality assurance/quality control, Clinical
Trials, including Manufacturing in support thereof, statistical analysis and
report writing, the preparation and submission of Drug Approval Applications,
regulatory affairs with respect to the foregoing and all other activities
necessary or reasonably useful or otherwise requested or required by a
Regulatory Authority as a condition or in support of obtaining or maintaining a
Regulatory Approval. When used as a verb, “Develop” means to engage in
Development, and “Developed” means to have engaged in Development. For purposes
of clarity, Development will include any submissions and activities required in
support thereof, required by Applicable Laws or a Regulatory Authority as a
condition or in support of obtaining a pricing or reimbursement approval for an
approved Compound, Product or Diagnostic Product.

1.53“Development Costs” means the FTE Costs (charged in accordance with Section
5.2.1(d)(ii) (FTE Records and Calculation)) incurred and the out-of-pocket costs
recorded as an expense in accordance with GAAP, by or on behalf of a Party or
any of its Affiliates, after the Effective Date and during the Term, that are
incurred in accordance with the Joint Development Plan and Budget and
specifically identifiable and directly attributable to the following Development
activities with respect to a Product in the Territory, as applicable:

(a)pre-clinical and non-clinical activities such as toxicology and formulation
development, test method development, stability testing, quality assurance,
quality control development and statistical analysis;

(b)Clinical Trials for a Compound, Product or Diagnostic Product, including:
(i) the preparation for and Conduct of Clinical Trials; (ii) data collection and
analysis and report writing; (iii) clinical laboratory work; (iv) regulatory
activities in direct connection with such studies, including adverse event
recording and reporting; and (v) advisory meetings in connection with a
Compound, Product or Diagnostic Product;

(c)the preparation of a regulatory dossier to the extent necessary to obtain any
Regulatory Approval for a Product in the Territory and filing fees in connection
with the filing of applications for Regulatory Approvals;

(d)(i) Manufacturing of Compound, Product or Diagnostic Product for use in
Clinical Trials or other Development activities for such Compound, Product or
Diagnostic Product; (ii) the Manufacture, purchase or packaging of comparators
or placebo (to the extent required by Clinical Trial design) for use in Clinical
Trials for a Compound, Product or Diagnostic Product (with the manufacturing
costs for comparators or placebo (to the extent required by Clinical Trial
design) to be determined in the same manner as Manufacturing Costs are
determined for such Compound, Product or Diagnostic Product); and (iii) costs
and expenses of disposal of drugs and other supplies used in such Clinical
Trials or other Development activities;

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(e)Third Party Payment, including the appropriate allocable portion of upfront
payments;

(f)Diagnostic Third Party Payments;

(g)maintaining the Global Safety Database (and, if applicable, the parallel
safety database) pursuant to Section 9.2 (Global Safety Database); and

(h)costs for the establishment of the Manufacturing process for a Compound,
Product or Diagnostic Product, scale-up, Manufacturing process validation,
including validation batches, Manufacturing improvements and qualification and
validation of Third Party contract manufacturers, but not including the purchase
or construction of capital equipment, capital assets or real estate for the
purposes of building manufacturing facilities and capabilities.

1.54“Development Overrun” has the meaning set forth in Section 5.2.1(d)(iii)
(Development Overruns).

1.55“Diagnostic Products” means Companion Diagnostic Products or Complementary
Diagnostic Products.

1.56“Diagnostic Third Party Payments” means all payments of any kind, including
upfront payments, milestone payments, royalties or other amounts paid by a Party
to a Third Party after the Effective Date and during the Term of this Agreement
that are in consideration of the supply of Diagnostic Products to the Parties or
a license of Patents that Cover or Information that is used in the making,
using, offering to sell, selling, importing or exporting of Diagnostic Products
in the Territory.

1.57“Distribution Costs” means the FTE Costs (charged in accordance with Section
5.2.2(c)(ii) (FTE Records and Calculation)) incurred, and the out-of-pocket
costs recorded as an expense in accordance with GAAP, by a Party or any of its
Affiliates after the Effective Date and during the Term that are incurred in
accordance with the Joint Commercialization Plan and Budget and specifically
identifiable and directly attributable to the commercial distribution of a Joint
Product to a Third Party in the U.S., including:

1.57.1handling and transportation to fulfill orders (excluding such costs, if
any, treated as a deduction in the definition of Net Sales);

1.57.2customer services, including order entry, billing and adjustments, inquiry
and credit and collection; and

1.57.3direct cost of storage and distribution of such Joint Product.

The Parties may, if appropriate, agree that Distribution Costs be determined on
the basis of a specified annual charge or as a percentage of Net Sales.

1.58“Dollars” or “$” means United States Dollars.

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1.59“Drug Approval Application” means any New Drug Application (“NDA”), as
defined in the FFDCA, or any corresponding foreign applications in the
Territory, including (a) with respect to the European Union, a Marketing
Authorization Application (a “MAA”) filed with the EMA pursuant to the
Centralized Approval Procedure or with the applicable Regulatory Authority of a
country in Europe with respect to the mutual recognition or any other regional
or national approval procedure or (b) with respect to Japan, an MAA filed with
the PMDA.

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

1.61“EMA” means the European Medicines Agency and any successor agency(ies) or
authority having substantially the same function.

1.62“Epizyme” has the meaning set forth in the Preamble.

1.63“Epizyme Carve-Out Patents” has the meaning set forth in Section 8.2.5(a)
(Joint Patents and Epizyme Product Patents).

1.64“Epizyme Indemnitees” has the meaning set forth in Section 12.1
(Indemnification of Epizyme).

1.65“Epizyme Know-How” means all Information that is (a) Controlled by Epizyme
or any of its Affiliates on the Effective Date or during the Term, (b) not
generally known and (c) reasonably necessary or useful for performing Research
Activities or for the Development, Manufacture or Commercialization of a
Compound, Product or a Diagnostic Product, but excluding any Information
comprising Joint Know-How or to the extent related to any active ingredient in a
Product that is not a Compound.

1.66“Epizyme Patents” means all of the Patents that (a) are Controlled by
Epizyme or any of its Affiliates on the Effective Date or during the Term and
(b) Covers subject matter that is reasonably necessary or useful (or, with
respect to patent applications, would be reasonably necessary or useful if such
patent applications were to issue as patents) for performing Research Activities
or for the Development, Manufacture or Commercialization of a Compound, Product
or a Diagnostic Product, but excluding any Joint Patents or any Patents solely
to the extent Covering any active ingredient in a Product that is not a
Compound.

1.67“Epizyme Product Patents” means any Epizyme Patent that Covers a Compound
(including the composition of matter), Product or a method of use of a Compound
or Product; provided that, with respect to Epizyme Patents that Cover the
Manufacture of a Compound or Product, such Patents shall only be Epizyme Product
Patents if such Patents are specifically and solely related to a Compound or
Product.

1.68“Epizyme Technology” means, collectively, the Epizyme Know-How and Epizyme
Patents.

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

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1.70“Excluded Claim” has the meaning set forth in Section 14.7.2(f) (ADR;
Arbitration).

1.71“Excluded Compound List” has the meaning set forth in the definition of BII
Research Compounds.

1.72“Exploit” or “Exploitation” means to make, have made, import, export, use,
have used, sell, have sold, or offer for sale, including to Develop,
Commercialize, register, modify, enhance, improve, Manufacture, have
Manufactured, hold or keep (whether for disposal or otherwise), formulate,
optimize, transport, distribute, promote or otherwise dispose of. When used as a
verb, “to Exploit” and “Exploiting” means to engage in Exploitation, and
“Exploited” has a corresponding meaning.

1.73“FDA” means the United States Food and Drug Administration and any successor
agency(ies) or authority having substantially the same function.

1.74“FFDCA” means the United States Federal Food, Drug, and Cosmetic Act, 21
U.S.C. § 301 et seq., as amended from time to time, together with any rules,
regulations and requirements promulgated thereunder (including all additions,
supplements, extensions, and modifications thereto).

1.75“Field” means any and all uses, including the diagnostic, prophylactic and
therapeutic treatment of humans and animals.

1.76“[**]” has the meaning set forth in Section 5.2.1(b)(ii) (Revisions).

1.77“First Commercial Sale” means, with respect to a Product and a country, the
first sale for monetary value in an arm’s-length transaction for use or
consumption by the end user of such Product in such country after Regulatory
Approval for such Product has been obtained in such country. Sales prior to
receipt of Regulatory Approval for a Product, such as so-called “treatment IND
sales,” “named patient sales,” and “compassionate use sales,” will not be
construed as a First Commercial Sale.

1.78“First In-Human Clinical Trial” means the first human clinical trial of a
Product that is Conducted in any country in the Territory in accordance with GCP
(whether a standalone trial or a stage of a “Phase 1/2” clinical trial described
in the protocol as the Phase 1 portion) that: (a) is intended to initially
evaluate the safety, tolerability, pharmacokinetic and sometimes pharmacological
effect of a Product (including evaluating such Product in target tissues,
collecting biologic materials from human subjects or patients and evaluating
such biologic materials for signs of pharmacodynamic activity of such Product)
and determine the maximum tolerated dose, biologically optimal dose or
recommended dose of a Product for subsequent human clinical trials; or (b) that
would otherwise satisfy requirements of 21 C.F.R. § 312.21(a), or its foreign
equivalent. For clarity, a First In-Human Clinical Trial may include an efficacy
component so long as such efficacy component is not the principal purpose of
such First In-Human Clinical Trial, and inclusion of such efficacy component
will not result in a First In-Human Clinical Trial being considered to be a
Non-Pivotal Clinical Trial or Pivotal Clinical Trial.

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1.79“FTE” means the equivalent of the work of one employee full time for one
Calendar Year (consisting of at least a total of [**] working hours per Calendar
Year, and always excluding vacation, holiday, sick, personal, or other like
time). No additional payment will be made with respect to any Person who works
more than [**] hours per Calendar Year and any Person who devotes less than [**]
hours per Calendar Year will be treated as an FTE on a pro rata basis based upon
the actual number of hours worked divided by [**].

1.80“FTE Cost” means, with respect to a Party for any period, the applicable FTE
Rate multiplied by the applicable number of FTEs of such Party performing
activities during such period.

1.81“FTE Rate” means the rate set forth on Schedule 1.81 (FTE Rate).

1.82“GAAP” means (i) for BII, the maintenance of records and books of accounts
in accordance with Handelsgesetzbuch (HGB), which standards or principles are
currently used at the relevant time, and consistently applied by BII and (ii)
for Epizyme, the maintenance of records and books of accounts in accordance with
Generally Accepted Accounting Principles in the United States, which standards
or principles are currently used at the relevant time, and consistently applied
by Epizyme.

1.83“Generic Competition” means, on a country-by-country and Product-by-Product
basis, the unit volume of Generic Products sold in a country by one or more
Third Parties in a Calendar Quarter is at least [**] percent ([**]%) of the
aggregate unit volume of Products sold in such country by BII, its Affiliates
and Sublicensees (or its or their distributors) and all Generic Products sold in
such country, based on data provided by IQVIA (formerly, Quintiles IMS Holdings,
Inc.) or, if such data is not available, such other reliable data source as
agreed upon by the Parties (such agreement not to be unreasonably withheld).

1.84“Generic Product” means, on a country by country basis with respect to a
Product, any generic product such as a product that contains the Compound as an
active ingredient; and is approved in reliance, in whole or in part, on the
prior approval (or on safety or efficacy data submitted in support of the prior
approval) of such Product as determined by the applicable Regulatory Authority,
including any product authorized for sale (i) in the U.S. pursuant to Section
505(b)(2) or Section 505(j) of the FFDCA (21 U.S.C. 355(b)(2) and 21 U.S.C.
355(j), respectively), (ii) in the E.U. pursuant to a provision of Articles 10,
10a or 10b of Parliament and Council Directive 2001/83/EC as amended (including
an application under Article 6.1 of Parliament and Council Regulation (EC) No
726/2004 that relies for its content on any such provision), or (iii) in any
other country or jurisdiction pursuant to all equivalents of such provisions,
including any amendments and successor statutes with respect to the subsections
(i) through (iii) thereto. A Product marketed under the same Drug Approval
Application as that of BII or any of its Affiliates but with the same or
different trade name (i.e., commonly known as an authorized generic product)
will not constitute a Generic Product.

1.85“Good Clinical Practice” or “GCP” means, with respect to any applicable
jurisdiction, the then-current standards, practices and procedures for clinical
trials for pharmaceuticals promulgated or endorsed by the applicable Regulatory
Authority in such jurisdiction (including, with respect to the United States,
the FDA) as set forth in the Applicable

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Laws of such jurisdiction, including, with respect to the United States, the
guidelines titled “Guidance for Industry E6 Good Clinical Practice: Consolidated
Guidance” and related regulatory requirements imposed by the FDA, and with
respect to jurisdictions outside the United States, comparable regulatory
standards, practices and procedures promulgated by the EMA, PMDA or other
Regulatory Authority, as applicable, including any applicable quality guidelines
promulgated under the International Conference on Harmonization (“ICH”), in each
case as they may be updated from time to time.

1.86“Good Laboratory Practice” or “GLP” means, with respect to any applicable
jurisdiction, the then-current standards, practices and procedures for
laboratory activities for pharmaceuticals promulgated or endorsed by the
applicable Regulatory Authority in such jurisdiction (including, with respect to
the United States, the FDA) as set forth in the Applicable Laws of such
jurisdiction, including, with respect to the United States, 21 C.F.R. Part 58
and related regulatory requirements imposed by the FDA, and with respect to
jurisdictions outside the United States, comparable regulatory standards,
practices and procedures promulgated by the EMA, PMDA or other Regulatory
Authority, as applicable, including any applicable quality guidelines
promulgated under the ICH, in each case as they may be updated from time to
time.

1.87“Good Manufacturing Practice” or “GMP” means, with respect to any applicable
jurisdiction, the then-current good manufacturing practices for the manufacture
and testing of pharmaceutical materials required by the applicable Regulatory
Authority in such jurisdiction (including, with respect to the United States,
the FDA) as set forth in the Applicable Laws of such jurisdiction, including,
with respect to the United States, the FFDCA, as amended, and the regulations
promulgated thereunder, and with respect to applicable jurisdictions outside the
United States, comparable regulatory standards, practices and procedures
promulgated by the EMA, PMDA or other Regulatory Authority, as applicable,
including the guidelines promulgated by the ICH designated ICH Q7A, titled “Q7A
Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients” and
the regulations promulgated thereunder, in each case as they may be updated from
time to time.

1.88“ICC” means the International Chamber of Commerce.

1.89“ICH” has the meaning set forth in the definition of “Good Clinical
Practice.”

1.90“IND” means an application filed with a Regulatory Authority for
authorization to commence Clinical Trials, including: (a) an Investigational New
Drug Application as defined in the FFDCA or any successor application or
procedure filed with the FDA; (b) any equivalent of a United States IND in other
countries or regulatory jurisdictions (i.e., clinical trial application); and
(c) all supplements, amendments, variations, extensions and renewals thereof
that may be filed with respect to any of the foregoing.

1.91“Indemnified Party” has the meaning set forth in Section 12.3 (Procedure).

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1.92“Indemnifying Party” has the meaning set forth in Section 12.3 (Procedure).

1.93“Indication” means a separate and distinct disease or medical condition in
humans and non-humans. For clarity, with respect to oncologic diseases,
Non-Small Cell Lung Cancer (“NSCLC”) is a separate and distinct disease from,
for example, Small Cell Lung Cancer, Breast Cancer, Colorectal Cancer, and
Melanoma and any similarly described conditions, however, any indication that
would allow for the treatment of patients who have NSCLC (or Colorectal Cancer,
or Breast Cancer, etc.) in a first line setting and/or a second line setting
and/or a third line setting (or any of these), such treatment lines would not
constitute a separate and distinct disease or medical condition.

1.94“Information” means all technical, scientific, business and other know-how,
information, trade secrets, knowledge, technology, means, methods, processes,
practices, formulae, instructions, skills, techniques, procedures, experiences,
ideas, technical assistance, designs, drawings, assembly procedures, computer
programs, apparatuses, specifications, data, results and other material,
including biological, chemical, pharmacological, toxicological, pharmaceutical,
physical and analytical, pre-clinical, clinical, safety, regulatory,
Manufacturing and quality control data and information, including study designs
and protocols, reagents (e.g., plasmids, proteins, cell lines, assays and
compounds) and biological methodology; in each case (whether or not
confidential, proprietary, patented or patentable, of commercial advantage or
not) in written, electronic or any other form now known or hereafter developed.

1.95“Initiation” or “Initiate” means, with respect to a Clinical Trial, the
first dosing of the first human subject or patient in such Clinical Trial.

1.96“Intellectual Property” has the meaning set forth in Section 13.2.5
(Termination for Insolvency).

1.97“Invoice” means an original invoice sent by Epizyme to BII with respect to
any payment due hereunder that contains the Information within Schedule 1.97.

1.98“IRB” means an institutional review board, ethics committee or other similar
body.

1.99“JCC” or “Joint Commercialization Committee” has the meaning set forth in
Section 2.4.2 (Joint Commercialization Committee).

1.100“Joint Commercialization Plan and Budget” has the meaning set forth in
Section 5.2.2(a)(i) (Joint Commercialization Plan and Budget).

1.101“Joint Compound” has the meaning set forth in Section 5.2.1(b)(i) (Initial
Development Plan and Budget).

1.102“Joint Counsel” has the meaning set forth in Section 8.2.4 (Joint Patents
and Epizyme Product Patents).

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1.103“Joint Counsel Patent Rights” has the meaning set forth in Section 8.2.4
(Joint Patents and Epizyme Product Patents).

1.104“Joint Development Plan and Budget” has the meaning set forth in Section
5.2.1(b)(i) (Initial Development Plan and Budget).

1.105“Joint Know-How” has the meaning set forth in Section 8.1.2 (Ownership of
Joint Technology).

1.106“Joint Patents” has the meaning set forth in Section 8.1.2 (Ownership of
Joint Technology).

1.107“Joint Product” has the meaning set forth in Section 5.2.1(b)(i) (Initial
Development Plan and Budget).

1.108“Joint Product Infringement” has the meaning set forth in Section 8.3.1
(Enforcement of Epizyme’s Patents and Joint Patents).

1.109“Joint Product Patents” means any Joint Patent that Covers a Compound
(including the composition of matter), Product, or a method of use of a Compound
or Product.

1.110“Joint Product Prosecuted Infringement” has the meaning set forth in
Section 8.3.1 (Enforcement of Epizyme’s Patents and Joint Patents).

1.111“Joint Technology” has the meaning set forth in Section 8.1.2 (Ownership of
Joint Technology).

1.112“Jointly Controlled Project” means the Target Project directed to the [**]
target but, for the avoidance of doubt, [**].

1.113 “JSC” or “Joint Steering Committee” has the meaning set forth in Section
2.1.1 (Formation).

1.114“Losses” has the meaning set forth in Section 12.1 (Indemnification of
Epizyme).

1.115“MAA” has the meaning set forth in the definition of “Drug Approval
Application”.

1.116“Major Markets” means each of the [**].

1.117“Manufacture” and “Manufacturing” means all activities related to the
synthesis, making, production, processing, purifying, formulating, filling,
finishing, packaging, testing and release, labeling, shipping, handling, storing
and holding of a Compound, any Product or any intermediate thereof, including
process development, process qualification and validation, scale-up,
pre-clinical, clinical and commercial production and analytic development,
product characterization, stability testing, quality assurance and quality
control.

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1.118“Manufacturing Costs” means the FTE Costs (charged in accordance with
Section 5.2.2(c)(ii) (FTE Records and Calculation)) incurred, and the
out-of-pocket costs recorded as an expense in accordance with GAAP, by or on
behalf of a Party or any of its Affiliates after the Effective Date and during
the Term that are incurred in accordance with the Joint Commercialization Plan
and Budget and specifically identifiable and directly attributable to the
following Manufacturing activities with respect to Joint Products in the U.S.
for Commercialization purposes:

1.118.1synthesis, making, production, processing, purifying, formulating a
Compound or Joint Product;

1.118.2filling, finishing, packaging and labelling;

1.118.3testing and releasing, shipping, handling storing and holding; and

1.118.4stability testing, quality assurance and quality control.

provided that, in no event will Manufacturing Costs include the purchase or
construction of capital equipment, capital assets or real estate for the
purposes of building manufacturing facilities and capabilities.

1.119“Materials” has the meaning set forth in Section 4.3.1(a) (Provision of
Materials).

1.120“Medical Affairs Activities” means, with respect to a Joint Product in the
U.S., the coordination of medical Information requests and field based medical
scientific liaisons with respect to such Joint Product, including activities
designed to ensure or improve appropriate medical use of, conduct medical
education of, or further research regarding such Joint Product, including (a)
conducting service based medical activities (including providing input and
assistance with consultancy meetings, recommending investigators for Clinical
Trials and providing input in the design of such trials and other research
related activities), (b) delivering non-promotional communications and
conducting non-promotional activities (including presenting new Clinical Trial
data and other scientific Information), (c) reviewing grants to support
continuing medical education or symposia related to the Joint Product, (d)
development, publication and dissemination of publications relating to the Joint
Product and relevant disease states in the United States, (e) conducting
advisory board meetings or other consultant programs, (f) supporting
investigator-initiated trials, (g) managing relationships with cooperative
groups, physician/hospital networks and advocacy groups, (h) establishing and
implementing risk, evaluation and mitigation strategies pertaining to the Joint
Product and (i) Conducting Phase IV Studies.

1.121“Medical Affairs Costs” means the FTE Costs (charged in accordance with
Section 5.2.2(c)(ii) (FTE Records and Calculation)) incurred, and the
out-of-pocket costs recorded as an expense in accordance with GAAP, by or on
behalf of a Party or its Affiliates after the Effective Date and during the Term
that are incurred in accordance with the Joint Commercialization Plan and Budget
and specifically identifiable and directly attributable to Medical Affairs
Activities with respect to any Joint Product sold in the United States,
including Phase IV Costs.

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1.122“Milestone Event” has the meaning set forth in Section 7.3 (Milestone
Payments).

1.123“Milestone Payment” has the meaning set forth in Section 7.3 (Milestone
Payments).

1.124“Net Losses” has the meaning set forth in the definition of “Net Profits.”

1.125“Net Profits” and, with correlative meaning, “Net Losses,” means, with
respect to a Joint Product, Net Sales of such Joint Product in the United
States, less Allowable Expenses (to the extent not already deducted from Net
Sales and with respect to the Joint Product in the United States).

1.126“Net Sales” means, with respect to a certain time period, the gross
invoiced sales charged for Product(s) sold by or for BII, its Affiliates and
Sublicensees in arm’s-length transactions to Third Parties (but not including
sales relating to transactions between BII, its Affiliates or their respective
Sublicensees) during such time period, less the total of the following charges
or expenses as determined in accordance with GAAP (as defined in this
Agreement), consistently applied across all products sold by BII and its
Affiliates, in each case without duplication:

1.126.1sales returns and allowances actually paid, granted or accrued, including
trade, quantity, prompt payment and cash discounts and any other adjustments,
including those granted on account of price adjustments or billing errors;

1.126.2credits or allowances actually granted for rejected goods, damaged or
defective goods, recalls and returns;

1.126.3rebates, chargeback rebates, compulsory rebates, reimbursements or
similar payments granted or given to wholesalers or other distributors, buying
groups, health care insurance carriers or other institutions (e.g. managed care
entities) and compulsory payments to governmental authorities and any other
governmental charges imposed upon the sale of such Product to Third Parties;

1.126.4retroactive price reductions applicable to sales of such Product;

1.126.5adjustments actually made in accordance with consumer discount programs
or other similar programs;

1.126.6the actual acquisition cost of devices used for dispensing or
administering the Product that are shipped with the Product and included in the
gross invoiced sales price;

1.126.7non-collectable receivables related to Product;

1.126.8customs or excise duties, sales tax, consumption tax, VAT and other taxes
(except income taxes); and

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1.126.9charges for packing, freight, shipping and insurance (to the extent that
BII, its Affiliates or Sublicensees bear the cost for Product).

BII and its Affiliates and Sublicensees shall not incur discounts, allowances,
credits, rebates or other deductions on the Product in order to advantage other
products of BII, its Affiliates or Sublicensees, such that the Product would
bear a disproportionate portion of such deductions (i.e., the Product would
serve as a loss leader for the benefit of other products). All defined
deductions in this section shall be consistent with BII’s, its Affiliates’ or
its Sublicensees’, as applicable, audited financial statements.

For the sake of clarity and avoidance of doubt, sales by BII and its Affiliates
or Sublicensees of a Product to a Recognized Agent of such Product in a given
country shall be considered a sale to a Third Party customer (the term
“Recognized Agent” used in this sentence shall mean any Third Party who
distributes Products directly to customers in countries where BII has no
Affiliate or Sublicensee).

Any disposal of Product for promotional or advertising purposes, or use of
Products in pre-clinical trials or Clinical Trials, given as free samples, or
transferred to Third Parties as part of an expanded access program,
compassionate sales or use program, an indigent program, or distributed at no
charge to patients unable to purchase Product shall not be included in Net
Sales. Donations for charity reasons shall also not be part of Net Sales.

Upon any sale or other disposal of any Product that should be included in Net
Sales for any consideration other than an exclusively monetary consideration on
bona fide arm’s-length terms, then for purposes of calculating the Net Sales
under this Agreement, such Product shall be deemed to be sold exclusively for
money at the average sales price charged for such Product during the applicable
reporting period achieved for such Product in the country in which such sale or
other disposal occurred when such Product is sold alone and not with other
products. In the event no sales price is available for the Product alone in such
country during the applicable reporting period, then such Product shall be
deemed to be sold exclusively for money at the arithmetic mean sales price
charged for such Product during the applicable reporting period generally
achieved for such Product in all countries in which such sale or other disposal
occurred when such Product is sold alone and not with other products; provided,
however, that if such Product is not sold alone in any country, then BII shall
calculate in good faith an estimated market price for the Product, allocating
the same proportion of costs, overhead and profit as are then allocated to all
similar products then being made and marketed by BII and having an ascertainable
market price, and shall provide Epizyme with a written summary  of the
methodology used by BII in arriving at such estimated market price.

If a Product is sold in the form of a Combination Product, then the Net Sales of
such Product for the purpose of calculating payments owed under this Agreement
for sales of such Product shall be determined as described below.
Notwithstanding the foregoing, Net Sales shall not include amounts (whether
actually existing or deemed to exist for purposes of calculation) for Product
distributed for use in Clinical Trials. In the event a Product is sold as a
Combination Product, Net Sales of the Combination Product will be calculated as
follows:

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1.126.10If the Combination Product, the Product and the other product are sold
separately, Net Sales of the Product portion of Combination Products will be
calculated by multiplying the total Net Sales of the Combination Product by the
fraction A/(A+B), where A is the average gross selling price in the applicable
country in the Territory of the Product sold separately in the same formulation
and dosage, and B is the sum of the average gross selling prices in the
applicable country in the Territory of all other therapeutically or
prophylactically active ingredients or products in the Combination Product sold
separately in the same formulation and dosage, during the applicable Calendar
Quarter.

1.126.11If the Combination Product and the Product are sold separately, but the
average gross selling price of the other product(s) cannot be determined, Net
Sales of the Combination Product shall be equal to the Net Sales of the
Combination Product multiplied by the fraction A/C wherein A is the average
gross selling price of the Product and C is the average gross selling price of
the Combination Product.

1.126.12If the Combination Product and the other product(s) are sold separately,
but the average gross selling price of the Product cannot be determined, Net
Sales of the Combination Product shall be equal to the Net Sales of the
Combination Product multiplied by the following formula: one (1) minus B/C
wherein B is the average gross selling price of the other product(s) and C is
the average gross selling price of the Combination Product.

1.126.13If the Combination Product are sold but the average gross selling price
of neither the Product nor the other product(s) can be determined, Net Sales of
the Combination Product shall be equal to Net Sales of the Combination Product
multiplied by a mutually agreed percentage.

The average gross selling price for such other product(s) contained in the
Combination Product shall be calculated for each Calendar Year by dividing the
sales amount by the units of such other product(s), as published by IQVIA or
another mutually agreed independent source.

In the initial Calendar Year during which a Combination Product is sold, a
forecasted average gross selling price shall be used for the Product, other
product(s), or Combination Product. Any overpayment or underpayment due to a
difference between forecasted and actual average gross selling prices shall be
paid or credited in the second royalty payment of the following Calendar Year.
In the following Calendar Year, the average gross selling price of the previous
Calendar Year shall apply from the second royalty payment on.

1.127“Non-Defaulting Party” has the meaning set forth in Section 13.2.1
(Termination of Agreement for Cause).

1.128“Non-Pivotal Clinical Trial” means a human clinical trial of a Product that
is Conducted in any country in the Territory (whether a standalone trial or a
stage of a “Phase 1/2” clinical trial described in the protocol as the Phase 2
portion, or a stage of a “Phase 2/3” clinical trial described in the protocol as
the Phase 2 portion) the principal purpose of which is: (a) to evaluate the
clinical efficacy, safety, pharmacodynamics or biological activity of such
Product (itself or other biological materials) in the target patient population
as its primary endpoint and is prospectively designed to generate sufficient
data that may permit commencement of a Pivotal Clinical Trial; or (b) that would
otherwise satisfy the requirements of 21 C.F.R. § 312.21(b), or its foreign
equivalent.

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1.129“Off-Cycle Amendment” has the meaning set forth in Section 5.2.1(b)(ii)
(Revisions).

1.130“Opt-Out Notice” has the meaning set forth in Section 5.2.5 (Epizyme
Opt-Out).

1.131“Opt-Out Royalties” has the meaning set forth in Section 5.2.5 (Epizyme
Opt-Out).

1.132“Party” and “Parties” has the meaning set forth in the Preamble.

1.133“Patent Liaisons” has the meaning set forth in Section 8.2.1 (Patent
Liaisons).

1.134“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; and (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)).

1.135“Patient Assistance Program Costs” means the FTE Costs (charged in
accordance with Section 5.2.2(c)(ii) (FTE Records and Calculation)) incurred,
and the out-of-pocket costs recorded as an expense in accordance with GAAP, by
or on behalf of a Party or any of its Affiliates after the Effective Date and
during the Term that are incurred in accordance with the Joint Commercialization
Plan and Budget and specifically identifiable to operating patient assistance
programs that aim to provide low-income or uninsured patients with free or
low-cost medications.

1.136“Person” means an individual, sole proprietorship, partnership, limited
partnership, limited liability partnership, corporation, limited liability
company, business trust, joint stock company, trust, unincorporated association,
joint venture or other similar entity or organization, including a government or
political subdivision, department or agency of a government.

1.137“Phase IV Costs” means the FTE Costs (charged in accordance with Section
5.2.2(c)(ii) (FTE Records and Calculation)) incurred, and the out-of-pocket
costs recorded as an expense in accordance with GAAP, by or on behalf of a Party
or any of its Affiliates after the Effective Date, during the Term of and
pursuant to this Agreement, that are specifically identifiable and directly
attributable to Phase IV Studies, wherever conducted, of a Joint Product in
support of Commercialization of such Joint Product in the U.S. and always
consistent with then-current Joint Commercialization Plan and Budget.

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1.138“Phase IV Study” means a post-marketing human clinical study for a Product
with respect to any Indication as to which Regulatory Approval has been received
or for a use that is the subject of an investigator-initiated study program.

1.139“Pivotal Clinical Trial” means a human clinical trial of a Product that is
Conducted in any country in the Territory (whether a standalone trial or a stage
of a multiple-stage clinical trial): (a) with a defined dose or a set of defined
doses of such Product designed to establish statistically significant efficacy
and safety of such Product for the purpose of enabling the preparation and
submission of a Drug Approval Application to the competent Regulatory
Authorities in a country of the Territory; (b) where the results of such
clinical trial are intended (if successful) to be used to establish both safety
and efficacy of such Product in patients which are the subject of such trial and
serve as the basis for initial or supplemental marketing authorization of such
Product in at least one Major Market; or (c) that would otherwise satisfy
requirements of 21 C.F.R. § 312.21(c), or its foreign equivalent. For the
avoidance of doubt, a Non-Pivotal Clinical Trial will be considered a Pivotal
Clinical Trial if the results of such Non-Pivotal Clinical Trial ultimately
serve as the basis for a Drug Approval Application, regardless of original
intent.

1.140“PMDA” means Japan’s Pharmaceuticals and Medical Devices Agency and any
successor agency(ies) or authority having substantially the same function.

1.141“Product” means any and all preparations in final form containing Compound
for use in the Field in the Territory, including BII Products and Joint
Products.

1.142“Product Insurance Costs” means the out-of-pocket costs recorded as an
expense in accordance with GAAP, by or on behalf of a Party or any of its
Affiliates after the Effective Date and during the Term that are incurred in
accordance with the Joint Commercialization Plan and Budget and specifically
identifiable and directly attributable to the premiums paid for Product
liability insurance.

1.143“Product Labeling” means, with respect to a Product in a country in the
Territory: (a) the Regulatory Authority‑approved full prescribing Information
for such Product for such country, including any required patient Information;
and (b) all labels and other written, printed, or graphic matter upon a
container, wrapper or any package insert utilized with or for such Product in
such country.

1.144 “Product Liability Costs” means the out-of-pocket costs (including
reasonable attorney’s fees) and awards recorded as an expense in accordance with
GAAP, by or on behalf of a Party or any of its Affiliates after the Effective
Date and during the Term of and pursuant to this Agreement that are specifically
identifiable and directly attributable to the costs of Product liability that
are not otherwise covered by insurance pursuant to Section 12.5 (Insurance) and
otherwise not subject to indemnification pursuant to ARTICLE 12 (Indemnity).

1.145“Product Marks has the meaning set forth in Section 8.1.5 (Ownership of
Product Marks).

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1.146“Prosecution and Maintenance” means, with respect to a Patent, preparation,
filing, prosecution and maintenance of such Patent, as well as post grant review
proceedings, reexaminations, reissues and the like with respect to such Patent,
together with the conduct of interferences, the defense of oppositions and other
similar proceedings with respect to the particular Patent; and “Prosecute and
Maintain” shall have the correlative meaning.

1.147“Publication Policies” has the meaning set forth in Section 10.6
(Publications).

1.148“Recall Costs” means the FTE Costs (charged in accordance with Section
5.2.2(c)(ii) (FTE Records and Calculation)) incurred, and the out-of-pocket
costs recorded as an expense in accordance with GAAP, by or on behalf of a Party
or any of its Affiliates after the Effective Date and during the Term of and
pursuant to this Agreement that are specifically identifiable and directly
attributable to conducting recalls, market suspensions or market withdrawals for
the Joint Product pursuant to Section 5.4 (Recalls).

1.149“Regulatory Approval” means, with respect to a country in the Territory,
any and all approvals (including Drug Approval Applications that have been
approved by a Regulatory Authority), licenses, registrations or authorizations
of any Regulatory Authority necessary to Commercialize a Product in such
country, excluding separate pricing or reimburseability approvals that may be
required or useful to Commercialize a Product.

1.150“Regulatory Authority” means any applicable supra-national, federal,
national, regional, state, provincial or local governmental or regulatory
authority, agency, department, bureau, commission, council or other entities
(e.g., the FDA, EMA and PMDA) regulating or otherwise exercising authority with
respect to activities contemplated in this Agreement, including the Exploitation
of Compounds or Products in the Territory.

1.151“Remedial Plan” has the meaning set forth in Section 4.1.2(b) (Satisfaction
of SoLO Criteria).

1.152“Replacement Product” has the meaning set forth in Section 7.3 (Milestone
Payments).

1.153“Research Activities” means those research and other activities undertaken
by the Parties pursuant to the Research Plan with respect to discovering,
characterizing, identifying and optimizing Compounds directed to (a) the [**]
target and (b) the [**] target.

1.154“Research Funding” has the meaning set forth in Section 7.2 (Research
Funding).

1.155“Research Period” has the meaning set forth in Section 3.2.1 (Initial
Research Period).

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1.156“Research Plan” means the Research and Development Plan and Budget attached
hereto as Schedule 1.156 (Research Plan) and described in Section 3.1 (Research
Plan), including the SoLO Criteria and SoD Criteria, as may be amended from time
to time pursuant to Section 3.3 (Amendments to Research Plan).

1.157“ROW” means all countries of the world other than the U.S.

1.158“Royalty Term” means, with respect to each Product and each country in the
Territory, the period beginning on the date of the First Commercial Sale of such
Product in such country, and ending on the [**] to occur of: (a) subject to
Section 8.2.5 (Patent Term Extensions), the expiration, invalidation or
abandonment date of the last Epizyme Patent, BII Patent or Joint Patent that
includes a Valid Claim that claims the composition of matter of the Compound for
such Product; or (b) the [**] anniversary of the First Commercial Sale of such
Product in such country.

1.159“Sales and Marketing Costs” means the FTE Costs (charged in accordance with
Section 5.2.2(c)(ii) (FTE Records and Calculation)) incurred, and the
out-of-pocket costs recorded as an expense, by a Party or any of its Affiliates
in accordance with GAAP after the Effective Date and during the Term that are
incurred in accordance with the Joint Commercialization Plan and Budget and
specifically identifiable and directly attributable to the sales and marketing
of a Joint Product in the United States. Sales and Marketing Costs shall include
amounts paid by a Party to Third Parties that are specifically identifiable and
directly attributable to the Commercialization of a Joint Product by such Third
Party in the U.S. Subject to the foregoing, Sales and Marketing Costs include
costs incurred in connection with the following activities (but in each case
only to the extent specifically identifiable and directly attributable to the
sales and marketing of a Joint Product in the United States):

1.159.1activities directed to the advertising and marketing of Joint Products in
the United States;

1.159.2launch meetings;

1.159.3advertising and public relations agencies, including development and
distribution of selling and advertising and promotional materials relating to
the use of a Joint Product, field literature, direct‑to‑consumer advertising
campaigns, media/journal advertising, distribution of such advertising and
promotional materials by a Party to its sales force personnel, exhibiting at
seminars and conventions, convention costs, and promotional premiums;

1.159.4speakers programs, including training of such speakers;

1.159.5developing, obtaining, and providing educational and training packages
for Joint Products, promotional literature, promotional materials, and other
selling materials, including shipment costs of the same to a Party’s central
distribution facility and from a Party’s central distribution facility to its
sales force personnel;

1.159.6transporting, housing and maintaining sales representatives for training
and the costs of all training materials used for such purpose;

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1.159.7developing and performing market research;

1.159.8developing Information and data specifically intended for national
accounts, managed care organizations, governmental agencies (e.g., federal,
state and local), and other group purchasing organizations, including
pull‑through activities;

1.159.9developing Product Trademarks, including style guides;

1.159.10Detail Costs; and

1.159.11operation and maintenance of the sales representatives that promote a
Joint Product in the U.S., sales bulletins and other communications, sales
meetings, specialty sales forces, call reporting and other monitoring/tracking
costs, district and regional sales management, home office personnel who support
the sales force, development and copying of training, motivational and
communications materials relating to Joint Products, and other services
ancillary to the foregoing.

1.160“SEC Filing” has the meaning set forth in Section 10.5 (Agreement
Redactions).

1.161“[**]” has the meaning set forth in Section 5.2.1(b)(ii) (Revisions).

1.162“Senior Officers” means, with respect to BII, [**], or a designee nominated
by such individual, and with respect to Epizyme, its Chief Executive Officer (or
his or her designee).

1.163“[**]” means [**].

1.164“[**]” means [**].

1.165“[**]” means [**].

1.166“SoD” or “Start of Development” means, with respect to a Compound, that
such Compound has demonstrated sufficient characteristics in pre-clinical
Development to warrant activities with respect to such Compound directed toward
the start of clinical Development of such Compound, which is expected to occur
prior to the initiation of IND-enabling toxicity studies of such Compound.

1.167“SoD Approval” has the meaning set forth in Section 4.2.2(b) (Satisfaction
of SoD Criteria).

1.168“SoD Criteria” has the meaning set forth in Section 3.1 (Research Plan).

1.169“SoLO” or “Start of Lead Optimization” means, with respect to a Compound,
that such Compound has demonstrated sufficient characteristics in pre-clinical
Development to warrant the start of lead optimization of such Compound.

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1.170“SoLO Approval” has the meaning set forth in Section 4.1.2(b) (Satisfaction
of SoLO Criteria).

1.171“SoLO Criteria” has the meaning set forth in Section 3.1 (Research Plan).

1.172“Sublicensee” has the meaning set forth in Section 6.4.2 (Sublicenses).

1.173“Target Projects” means, collectively, the two (2) projects conducted by
the Parties pursuant to the Research Plan related to the discovery and research
of Compounds that are inhibitors to (a) the [**] target and (b) the [**] target,
and the corresponding and resulting Joint Compound or Joint Product on the one
hand, and BII Compound or BII Product on the other hand, as these are further
Developed and Commercialized by the Parties or by BII under this Agreement. When
used in the singular, “Target Project” means either the [**] target project
(including any Joint Compound or Joint Product) or the [**] target project
(including any BII Compound or BII Product), as the context requires.

1.174“Term” has the meaning set forth in Section 13.1.1 (Term).

1.175“Territory” means ROW and the United States.

1.176“[**]” has the meaning set forth in Section 5.2.1(b)(ii) (Revisions).

1.177“Third Party” means any Person other than Epizyme and its Affiliates and
BII and its Affiliates.

1.178“Third Party Claims” has the meaning set forth in Section 12.1
(Indemnification of Epizyme).

1.179“Third Party Payments” means all upfront payments, milestone payments or
royalties paid by a Party to a Third Party after the Effective Date and during
the Term of and pursuant to this Agreement that are in consideration of a
license of Patents that Cover, or Information that is used in, the making,
using, offering to sell, selling, importing or exporting of a Compound or
Product in the Territory.

1.180“Trademark” means any word, name, symbol, color, designation or device or
any combination thereof that functions as a source identifier, including any
trademark, trade dress, brand mark, service mark, trade name, brand name, logo,
business symbol or domain names, whether or not registered.

1.181“Trademark Costs” means those out‑of‑pocket costs (including the reasonable
fees and expenses paid to outside counsel and other Third Parties, and filing
and maintenance fees paid to governmental authorities) recorded as an expense by
a Party or any of its Affiliates in accordance with GAAP after the Effective
Date, during the Term of and pursuant to this Agreement, (a) in connection with
the prosecution and maintenance of rights, including filing and registration
fees with respect to the Trademark(s) for the Joint Products in the U.S. and
(b) the costs of litigation (enforcement or defense) or other proceedings, under
the Trademark(s) for the Joint Products in the U.S., only to the extent not
reimbursed by a Third Party.

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1.182“Transition Agreement” has the meaning set forth in Section 13.3.2(f)
(Transition Agreement).

1.183“United States” or “U.S.” means the United States of America and its
territories and possessions (including the District of Columbia and Puerto
Rico).

1.184“Valid Claim” means, as applicable, a claim in any (a) unexpired and issued
Patent that has not been disclaimed, revoked or held invalid by a final
non-appealable decision of a court of competent jurisdiction or government
agency or (b) a pending Patent application that has not been finally abandoned,
finally rejected or expired (after exhaustion of all appeals); provided that, if
a claim of a pending Patent application shall not have been issued within [**]
after the earliest filing date from which such claim takes priority, such claim
shall not constitute a Valid Claim for the purposes of this Agreement unless and
until a Patent issues with respect to such claim.

1.185“VAT” has the meaning set forth in Section 7.7 (Taxes; Withholding Taxes).

1.186“Voting Stock” has the meaning set forth in the definition of “Change in
Control.”

1.187“Working Group” has the meaning set forth in Section 2.4.1 (Working Groups
– Generally).

ARTICLE 2
Collaboration Management

2.1.Joint Steering Committee.

2.1.1Formation. Within [**] of the Effective Date (or such later date as may be
agreed to by the Parties), the Parties will establish a joint steering committee
(the “JSC”). The JSC shall consist of an equal number of representatives from
each of the Parties, each of whom will have the requisite experience and
seniority to enable such Person to make decisions on behalf of the Parties with
respect to the issues falling within the jurisdiction of the JSC. Each Party
shall select from its representatives a chairperson for the JSC. From time to
time, each Party may substitute one or more of its representatives to the JSC
upon written notice (including by email or otherwise) to the other Party.

2.1.2Specific Responsibilities. Subject to the limitations on its authority
imposed by Section 2.1.3 (Limitations on Authority), the JSC shall provide
oversight and decision-making for all matters arising in connection with this
Agreement, including by serving as a forum for planning, reviewing and
coordinating activities related to Target Projects, Compounds, Products and
Diagnostic Products. In particular, the JSC will be responsible for:

(a)establishing Working Groups from time to time pursuant to Section 2.4
(Working Groups);

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(b)periodically reviewing and, as necessary, approving proposed amendments to
the Research Plan pursuant to Section 3.3 (Amendments to the Research Plan);

(c)overseeing Epizyme’s undertaking of characterization, validation and
identification activities (if any) pursuant to Section 4.1.1 (SoLO Performance
Obligation) that are necessary for SoLO Approval;

(d)determining whether to nominate a [**] inhibitor or [**] inhibitor to BII for
SoLO Approval pursuant to Section 4.1.2(a) (Satisfaction of SoLO Criteria) and
to nominate a Compound to BII for SoD Approval pursuant to Section 4.2.2(a)
(Satisfaction of SoD Criteria);

(e)determining whether to re-nominate a [**] inhibitor or [**] inhibitor to BII
for SoLO Approval upon completing a Remedial Plan with respect thereto pursuant
to Section 4.1.2 (Satisfaction of SoLO Criteria) and to re-nominate a Compound
to BII for SoD Approval upon completing a Remedial Plan with respect thereto
pursuant to Section 4.2.2(b) (Satisfaction of SoD Criteria);

(f)approving the (i) Joint Development Plan and Budget pursuant to Section
5.2.1(b)(i) (Initial Development Plan and Budget) and (ii) Joint
Commercialization Plan and Budget pursuant to Section 5.2.2(a)(i) (Initial
Commercialization Plan and Budget), with respect to (i)-(ii), including all
revisions and all amendments thereto;

(g)(i) monitoring the Development of Joint Products for the United States and
serving as the decision-making forum with respect to decisions impacting the
Development of the Joint Product for the United States, including with respect
to determining (A) the specific Clinical Trials to be Conducted (including those
that are committed and those that are conditioned based upon the results of
ongoing Clinical Trials), (B) the anticipated timelines for such Clinical Trials
and (C) the Clinical Trial activities to be assigned to each Party and (ii)
monitoring the Development of the Joint Product for the ROW and serving as a
forum for the Parties with respect to discussing matters affecting the
Development of the Joint Product for the ROW and U.S. and Information sharing
with respect thereto, with respect to (i)-(ii), pursuant to Section 5.2.1(c)
(JSC Development Responsibility);

(h)(i) monitoring the Commercialization of Joint Products in the United States
and serving as the decision-making forum with respect to strategic decisions
impacting the Commercialization of the Joint Product in the United States,
including with respect to establishing (A) a general Commercialization strategy
(including life-cycle plans), (B) anticipated timelines for launch, (C) pricing
and reimbursement strategy, (D) branding strategy, (E) supply chain and
distribution strategy, (F) packaging and labeling, (G) advertising and public
relations agencies of record, (H) market research strategy, (I) sales force
strategy, (J) sizing and alignment, planned physician detail equivalents,
deployment and incentive compensation guidelines, (K) revenue forecasts, (L)
sales objectives, (M) Medical Affair Activities and (N) allocating specific
accounts or geographies to a Party and (ii) serving as a forum for the Parties
with respect to discussing matters affecting the Commercialization of the Joint
Product for the ROW and U.S. and Information sharing with respect thereto, with
respect to (i)-(ii), pursuant to Section 5.2.2(b) (JSC Commercialization
Responsibility);

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(i)following notice from Epizyme pursuant to Section 5.2.3 (Adverse Actions),
discussing (i) Epizyme’s concerns that BII’s proposed regulatory or
Commercialization activities in a ROW country could adversely affect a Product’s
Development or Commercialization in the U.S. and (ii) whether BII should amend
its proposed regulatory or Commercialization activities based on Epizyme’s
concerns;

(j)establishing the pre-clinical, clinical and commercial supply strategy for
Joint Compounds and Joint Products in the U.S. pursuant to Section 5.3.1 (Supply
Plans);

(k)developing and approving Publication Policies and reviewing abstracts,
manuscripts and presentations pursuant to Section 10.6 (Publications); and

(l)performing such other functions as are set forth in this Agreement or as the
Parties may mutually agree in writing, except where in conflict with any
provision of this Agreement.

2.1.3Limitations on Authority.

(a)For the BII Controlled Project, the scope of the JSC’s oversight and
decision-making authority shall be limited to those activities set forth in the
Research Plan that occur prior to SoD Approval for the BII Controlled Project.

(b)For the Jointly Controlled Project, the scope of the JSC’s oversight and
decision-making authority shall extend to all matters arising in connection with
this Agreement; provided that, other than serving as a forum for the
coordination of ROW matters and Information sharing with respect thereto, the
JSC will have no authority to direct Development, regulatory or
Commercialization matters that pertain specifically to ROW.

(c)The JSC will not have the power to amend, modify or waive compliance with
this Agreement (including the SoLO Criteria and SoD Criteria set forth in the
Research Plan), which may only be amended or modified as provided in
Section 14.9 (Entire Agreement; Amendments) or compliance with which may only be
waived as provided in Section 14.12 (Waiver and Non-Exclusion of Remedies).

(d)Each Party will retain the rights, powers and discretion granted to it under
this Agreement and no such rights, powers or discretion will 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.

2.1.4Disbandment.

(a)In the event that Epizyme provides BII with an Opt-Out Notice pursuant to
Section 5.2.5 (Epizyme Opt-Out), unless otherwise mutually agreed in writing by
the Parties, the JSC shall be disbanded upon the effective date of the Opt-Out
Notice as set forth in Section 5.2.5 (Epizyme Opt-Out).

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(b)In the event that BII elects, pursuant to Section 14.2.1 (U.S.
Commercialization Rights), to terminate Epizyme’s Development and
Commercialization rights, responsibilities and obligations with respect to the
Joint Compound and Joint Product in the U.S. and to vest all such rights,
responsibilities and obligations for the Joint Compound and Joint Product in
BII, then, unless otherwise mutually agreed in writing by the Parties, the JSC
shall be disbanded as set forth in the transition plan agreed to by the Parties
pursuant to Section 14.2.1 (U.S. Commercialization Rights). If the JSC is
disbanded as set forth in this Section 2.1.4(b), then at least [**] prior to the
start of the [**], BII will provide Epizyme (or its successor) with a
non-binding, good faith, written estimate of the Development Costs and Allowable
Expenses that BII reasonably expects to incur (or have incurred on its behalf)
for the remainder of the [**] in which the JSC was disbanded, which estimate
will be provided on a [**] basis. Contemporaneously with delivery of the
foregoing estimate, BII will also provide Epizyme (or its successor) with a
non-binding, good faith, written estimate of the Development Costs and Allowable
Expenses that BII reasonably expects to incur (or have incurred on its behalf)
for the [**] following the [**] in which the JSC is disbanded, which estimate
will be provided on a [**] basis. Thereafter, BII will provide revised estimates
to Epizyme (or its successor) [**] so that Epizyme (or its successor) always has
a written estimate of the Development Costs and Allowable Expenses that BII
reasonably expects to incur (or have incurred on its behalf) during the ensuing
[**] period, which estimates will be provided (i) on a [**] basis with respect
to the [**] of such [**] period and (ii) on a [**] basis, with respect to the
[**] of such [**] period. For the avoidance of doubt, any such estimates
provided by BII to Epizyme (or its successor) are non-binding and BII shall in
its sole discretion determine and conduct Development and Commercialization
activities (always subject to Commercially Reasonable Efforts) for which
Development Costs or Allowable Expenses are incurred in any such period,
regardless of whether such actual costs and expenses incurred deviate
substantially more or less from those Development Costs or Allowable Expenses
reflected in such estimates.

(c)In the event the JSC is disbanded pursuant to this Section 2.1.4
(Disbandment) with respect to [**], all rights, responsibilities and obligations
assigned to the JSC pursuant to this Agreement for [**] shall instead be deemed
to be assigned to BII and BII shall have sole decision-making authority with
respect thereto.

2.2.General Provisions Applicable to Joint Committees.

2.2.1Meetings and Minutes. The JSC will meet [**], and more frequently should
the chairpersons mutually agree. The location of such meetings will alternate
between locations designated by Epizyme and locations designated by BII. Both
Party’s chairpersons shall initially establish the schedule of JSC meetings, and
such schedule shall be continually updated to provide for the meetings times and
locations for the next [**]. Each Party will make all proposals for agenda items
and will provide all appropriate Information with respect to such proposed items
at least [**] in advance of the applicable meeting; provided that, under exigent
circumstances requiring input by the JSC, a Party may provide its agenda items
to the other Party within a shorter period of time in advance of the meeting, or
may propose that there not be a specific agenda for a particular meeting, so
long as the other Party consents to such later addition of such agenda items or
the absence of a specific agenda for such meeting, such consent not to be
unreasonably withheld or delayed. The JSC will designate an individual to
prepare and circulate for review and approval of the Parties minutes of each
meeting [**] after the meeting. The Parties will agree on the minutes of each
meeting promptly, but in no event later than [**] after the meeting, and a
representative of each Party will execute such agreed minutes.

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2.2.2Procedural Rules. The JSC will have the right to adopt such standing rules
as will be necessary for its work, to the extent that such rules are not
inconsistent with this Agreement. A quorum of the JSC will exist whenever there
is present (for clarity, in accordance with the participation options given in
the immediately following sentence) at a meeting at least [**] appointed by each
Party. Each Party’s JSC representatives 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. The JSC will take
action by consensus of the representatives present at a meeting at which a
quorum exists, with each Party having a single vote irrespective of the number
of representatives of such Party in attendance, or by a written resolution
signed by at least one representative appointed by each Party. Alliance Managers
and, with the prior consent of the other Party (not to be unreasonably withheld
or delayed) and on a need to participate basis, other employees or consultants
of either Party who are not representatives of such Party on the JSC, may attend
meetings of the JSC; provided that such attendees: (a) will not vote in the
decision-making process of the JSC; and (b) are bound by obligations of
confidentiality and non-disclosure equivalent at least as protective of the
other Party as to those set forth in ARTICLE 10 (Confidentiality and
Non-Disclosure).

2.2.3Disagreement Resolution. If the JSC cannot, or does not, reach consensus on
an issue that is within the scope of its responsibilities at any JSC meeting or
within a period of [**] thereafter, then the disagreement will first be referred
to the Senior Officers of the Parties, who will confer in good faith on the
resolution of the issue. Any final decision mutually agreed to by the Senior
Officers will be conclusive and binding on the Parties. If the Senior Officers
are not able to agree on the resolution of any such issue within [**] after such
issue was first referred to them, then (a) with respect to disagreements related
to the BII Controlled Project, the Senior Officer of [**] shall have final
decision-making authority with respect thereto, without recourse to the dispute
resolution process set forth in Section 14.7 (Dispute Resolution) and (b) with
respect to disputes related to the Jointly Controlled Project, (i) the Senior
Officer of [**] shall have final decision-making authority with respect to all
matters arising prior to [**] for the Jointly Controlled Project and (ii) the
Senior Officer of [**] shall have final decision-making authority with respect
to all matters that arise following [**] for the Jointly Controlled Project,
with respect to (i)-(ii), without recourse to the dispute resolution process set
forth in Section 14.7 (Dispute Resolution); provided that, with respect to
(a)-(b), each Party shall exercise its final decision-making authority in good
faith. Notwithstanding the foregoing, in no event (A) may BII exercise its final
decision-making authority to impose on Epizyme an obligation to perform a
Development, Manufacturing or Commercialization activity with respect to the
Jointly Controlled Project without Epizyme’s consent, (B) may either Epizyme or
BII exercise its final decision-making authority to amend the SoLO Criteria or
SoD Criteria, (C) may BII exercise its final decision-making authority to force
the Parties to share a Development Overrun pursuant to Section 5.2.1(d)(iii)
(Development Overruns) or (D) may BII exercise its final decision-making
authority to force the Parties to share a Commercialization Overrun pursuant to
Section 5.2.2(c)(iv) (Commercialization Overruns).

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2.2.4Alliance Manager. Each Party will appoint one employee of such Party who
will oversee contact between the Parties for all matters between meetings of
each JSC and will have such other responsibilities as the Parties may agree in
writing after the Effective Date (each, an “Alliance Manager”). Each Party may
replace its Alliance Manager at any time by notice in writing (including by
email or otherwise) to the other Party. The Alliance Managers will work together
to manage and facilitate the communication between the Parties under this
Agreement, including the resolution (in accordance with the terms of this
Agreement) of issues between the Parties that arise in connection with this
Agreement.

2.3.Interactions Between JSC and Internal Teams. The Parties recognize that each
Party possesses an internal structure (including various committees, teams and
review boards) that will be involved in administering such Party’s activities
under this Agreement. Nothing contained in this ARTICLE 2 (Collaboration
Management) will prevent a Party from making routine day-to-day decisions
relating to the conduct of those activities for which it has a performance or
other obligations hereunder, in each case in a manner consistent with the
then-current Research Plan or, as applicable, and the terms and conditions of
this Agreement.

2.4.Working Groups.

2.4.1Generally. From time to time, the JSC may establish and delegate duties to
subcommittees or directed teams (each, a “Working Group”) on an “as-needed”
basis to oversee particular projects or activities (e.g., a Development Working
Group responsible for clinical efforts in the Territory). Each such Working
Group will be constituted and will operate as the JSC determines; provided that
each Working Group will have equal representation from each Party, unless
otherwise mutually agreed. Working Groups may be established on an ad hoc basis
for purposes of a specific project or on such other basis as the JSC may
determine. Each Working Group and its activities will be subject to the
oversight, review and approval of, and will report to, the JSC. In no event will
the authority of the Working Group exceed that specified by the JSC for such
Working Group. All decisions of a Working Group will be by consensus. Any
disagreement between the designees of BII and Epizyme with respect to a Working
Group will be referred to the JSC for resolution.

2.4.2Joint Commercialization Committee. Upon the earlier of (a) [**] for a Joint
Product in the Territory or (b) [**] prior to the anticipated First Commercial
Sale of a Joint Product in the U.S., the JSC shall establish a Working Group
responsible for overseeing the Commercialization of the Joint Product in the
U.S. (the “JCC” or “Joint Commercialization Committee”) and shall specify the
specific responsibilities of the JCC (which may include responsibilities of the
JSC described in Section 2.1.2 (Specific Responsibilities)). The JCC will
generally operate in accordance with Section 2.1.1 (Formation), Section 2.2.1
(Meetings and Minutes) and Section 2.2.2 (Procedural Rules), as applicable.
Disputes that cannot be resolved at the JCC will be referred to the JSC for
resolution in accordance with Section 2.2.3 (Disagreement Resolution).

2.5.Expenses. Each Party will be responsible for all travel and related costs
and expenses for its members and other representatives to attend meetings of,
and otherwise participate on, the JSC or other Working Group.

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ARTICLE 3
Research Plan; Research Period

3.1.Research Plan. As more fully set forth in this Agreement, BII and Epizyme
shall conduct Research Activities allocated to such Party for each Target
Project pursuant to the Research Plan. The Research Plan shall set forth (a) the
overall objectives of each Target Project, (b) a list of criteria to be used to
determine SoLO (the “SoLO Criteria”) and a list of criteria to be used to
determine SoD (the “SoD Criteria”) for such Target Project, (c) the Research
Activities to be conducted by the Parties in connection with such Target
Project, including the work packages to be generated by the Parties in
connection with its Research Activities, (d) the resources to be allocated by
each Party in connection with such Target Project and (e) the budget for such
Target Project.

3.2.Research Period.

3.2.1Initial Research Period. With respect to a Target Project, the term of the
Research Plan for such Target Project shall commence on the Effective Date and
continue (unless sooner terminated pursuant to ARTICLE 13 (Term and
Termination)) until the earlier to occur of (a) December 31, 2019 (unless
extended pursuant to Section 3.2.2 (Extension)) or (b) [**] (the “Research
Period”).

3.2.2Extension. If BII believes, acting reasonably and in good faith, that [**]
will likely not be achieved by December 31, 2019, then BII, in its sole
discretion, may elect to extend the initial Research Period for such Target
Project by providing written notice to Epizyme of such election no later than
[**], which notice shall set forth the duration of such extension (not to exceed
an additional twelve (12) month period). Upon receipt of such extension notice
provided by BII pursuant to this Section 3.2.2 (Extension), the Parties shall,
upon mutual written agreement, promptly amend the Research Plan to include (a)
the additional Research Activities (including Research Activities that may have
been set forth in the existing Research Plan that Epizyme did not complete by
December 31, 2019) to be performed by the Parties on account of such extension,
(b) any additional work packages (including work packages that may have been set
forth in the existing Research Plan that Epizyme did not generate by December
31, 2019) to be generated by the Parties on account of such extension, (c) any
additional resources (including resources that may be required to complete the
activities or generate the work packages set forth in subclause (a) or (b)
above) to be allocated by the Parties on account of such extension and (d)
pursuant to Section 7.2.2 (Research Funding – Calendar Year 2020), the
additional Research Funding to be paid to Epizyme on account of such extension,
which additional Research Funding shall be appropriate and commercially
reasonable with respect to the additional Research Activities to be performed
and resources to be expended. The Research Period for such Target Project shall
be deemed extended by the period set forth in any notice provided by BII
pursuant to this Section 3.2.2 (Extension) upon the mutual agreement of the
Parties with respect to the matters set forth in the immediately preceding
sentence. If the Parties are unable to reach mutual agreement with respect to
such matters by [**], then BII may solely decide to perform, at its sole
expense, any additional research activities from January 1, 2020 onwards with
respect to the applicable Target Project, subject to JSC oversight as
applicable, and with BII having final decision making with respect to any JSC
decisions notwithstanding the provisions found in Section 2.2.3 (Disagreement
Resolutions).

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3.3.Amendments to the Research Plan. Either Party may, acting through its
representatives on the JSC, propose amendments to the Research Plan at any time.
The JSC may amend the Research Plan provided such amendments are mutually agreed
to by the JSC representatives of each Party (without reference to the
tie-breaking provisions of Section 2.2.3 (Disagreement Resolution)) and in no
event may the JSC amend the SoLO Criteria or SoD Criteria, unless such
amendments are mutually agreed to by the Parties as provided in Section 14.9
(Entire Agreement; Amendments).

ARTICLE 4
Research Program

4.1.Prior to SoLO.

4.1.1SoLO Performance Obligation. Following the Effective Date, Epizyme shall,
in accordance with the Research Plan, use Commercially Reasonable Efforts to (a)
further characterize and validate the [**] target and [**] target (if further
efforts are needed) and (b) conduct research to identify and characterize [**]
inhibitors and [**] inhibitors for BII to determine, acting reasonably and in
good faith, whether a [**] inhibitor and [**] inhibitor has satisfied the SoLO
Criteria for a Target Project. Subject to BII’s obligation to provide Research
Funding to Epizyme pursuant to the Section 7.2 (Research Funding), Epizyme shall
bear the costs of all Research Activities undertaken by Epizyme pursuant to this
Section 4.1.1 (SoLO Performance Obligation).

4.1.2Satisfaction of SoLO Criteria.

(a)If Epizyme believes that a [**] inhibitor or [**] inhibitor has met all of
the SoLO Criteria for the applicable Target Project, then it shall notify the
JSC. The JSC shall discuss and review the Research Plan results that pertain to
such inhibitors and criteria, and decide whether the SoLO Criteria have been
met. If the JSC representatives of each Party mutually agree in good faith
(without reference to the tie-breaking provisions of Section 2.2.3 (Disagreement
Resolution)) that the SoLO Criteria have been met, then the JSC shall so notify
BII in writing, which notice shall be accompanied by a report containing
Information in sufficient detail to demonstrate that the SoLO Criteria have been
achieved for such [**] inhibitor or [**] inhibitor, as applicable. Upon BII’s
receipt of such written notice and report, BII will promptly inform its [**]
(collectively, the “BII SoLO Committee”) of the JSC’s belief that the relevant
[**] inhibitor or [**] inhibitor should be considered for SoLO Approval and will
initiate a process for the BII SoLO Committee to determine whether or not such
[**] inhibitor or [**] inhibitor should receive SoLO Approval. For the avoidance
of doubt, the JSC may always decide to nominate a [**] inhibitor or [**]
inhibitor prior to such [**] inhibitor or [**] inhibitor, as applicable, meeting
all of the SoLO Criteria for the applicable Target Project provided the members
of the JSC of each Party mutually agree (without reference to the tie-breaking
provisions of Section 2.2.3 (Disagreement Resolution)).

(b)Within [**] of BII’s receipt of such report, the BII SoLO Committee shall
notify the JSC in writing that SoLO has occurred for the Target Project with
respect to such [**] inhibitor or [**] inhibitor (the “SoLO Approval”), unless
the BII SoLO Committee, acting reasonably and in good faith, has a scientific or
commercial reason for

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withholding SoLO Approval for such [**] inhibitor or [**] inhibitor. In the
event that the BII SoLO Committee has such a reason for withholding SoLO
Approval for a [**] inhibitor or [**] inhibitor, the BII SoLO Committee (or its
designee) shall provide the JSC with written notice of its reasons and a plan
aimed at remedying such concerns (each, a “Remedial Plan”) with respect to such
nominated [**] inhibitor or [**] inhibitor, which Remedial Plan may include the
performance or re-performance of Research Activities that were set forth in the
existing Research Plan or performance of additional Research Activities not set
forth in the existing Research Plan and, if such Remedial Plan does include the
performance of additional Research Activities not set forth in the then existing
Research Plan, then such Remedial Plan shall include a reasonable timeline for
completing such additional Research Activities. Subject to Section 3.2.2
(Extension), with respect to Research Activities set forth in the Remedial Plan,
Epizyme will bear the costs of conducting any such Research Activities that were
set forth in the existing Research Plan that were not completed at the time the
[**] inhibitor or [**] inhibitor was nominated for SoLO Approval consideration
pursuant to Section 4.1.2(a) (Satisfaction of SoLO Criteria), while the costs of
any such Research Activities not set forth in the existing Research Plan (i.e.,
additional Research Activities) shall be at (i) BII’s cost if (A) the Remedial
Plan requires that BII perform any additional research activities with respect
to any [**] inhibitor or [**] inhibitor, (B) the entirety of the SoLO Criteria
were met for a [**] inhibitor or [**] inhibitor, but the BII SoLO Committee
nevertheless withholds SoLO Approval for such [**] inhibitor or [**] inhibitor
or (C) the work contemplated in the Remedial Plan is intended to produce results
or data that is not included in the SoLO Criteria (and not already covered under
the existing Research Plan) and (ii) Epizyme’s costs if the JSC members mutually
agreed (without reference to the tie-breaking provisions of Section 2.2.3
(Disagreement Resolution)) to nominate a [**] inhibitor or [**] inhibitor for
SoLO Approval prior to such [**] inhibitor or [**] inhibitor meeting all of the
SoLO Criteria for the applicable Target Project.

(c)Upon completion of the Remedial Plan, the JSC shall notify BII in writing,
which notice shall be accompanied by a report containing Information in
sufficient detail to demonstrate that the Remedial Plan was completed. Upon
BII’s receipt of such written notice and report, BII will promptly inform the
BII SoLO Committee. Within [**] of BII’s receipt of such report, the BII SoLO
Committee will provide the JSC with SoLO Approval with respect to the applicable
[**] inhibitor or [**] inhibitor, unless BII has further scientific or
commercial reasons for withholding SoLO Approval for such [**] inhibitor or [**]
inhibitor. If BII has further scientific or commercial reasons for withholding
SoLO Approval, then Epizyme shall continue to perform in accordance with the
Research Plan and BII may solely decide to perform any additional research
related activities not set forth in the Research Plan with respect to achieving
SoLO Approval for a Target Project or Compound, subject to JSC oversight as
applicable, and with BII having final decision making with respect to any JSC
decisions with respect to such additional research related activities
notwithstanding the provisions found in Section 2.2.3 (Disagreement
Resolutions).

4.1.3Allocation of Responsibilities Following SoLO Approval. Following SoLO
Approval for a Target Project but prior to SoD for such Target Project, as more
fully set forth in the Research Plan and Section 4.2 (Following SoLO But Prior
to SoD), (a) with respect to the BII Controlled Project, BII shall be primarily
responsible for and assume the operational activities concerning such Target
Project; provided that Epizyme shall assist BII as set forth in the Research
Plan or as may be mutually agreed to by the Parties and (b) with respect

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to the Jointly Controlled Project, Epizyme shall be primarily responsible for
and assume the operational activities concerning such Target Project; provided
that BII shall assist Epizyme as set forth in the Research Plan or as may be
mutually agreed to by the Parties.

4.2.Following SoLO but Prior to SoD

4.2.1Research Performance Obligation. Following SoLO Approval for a particular
Target Project, each Party shall use Commercially Reasonable Efforts to perform
its Research Activities under the Research Plan for each Target Project during
the applicable Research Period applicable to such Target Project to achieve the
SoD Criteria for each Target Project. Subject to BII’s obligation to provide
Research Funding to Epizyme pursuant to the Section 7.2 (Research Funding),
Epizyme shall bear the costs of all Research Activities undertaken by Epizyme
pursuant to this Section 4.2.1 (Research Performance Obligation).

4.2.2Satisfaction of SoD Criteria.

(a)If Epizyme believes that a Compound has met all of the SoD Criteria for the
applicable Target Project, then it shall notify the JSC. The JSC shall discuss
and review the Research Plan results that pertain to such inhibitors and
criteria, and decide whether the SoD Criteria have been met. If the JSC
representatives of each Party mutually agree in good faith (without reference to
the tie-breaking provisions of Section 2.2.3 (Disagreement Resolution)) that the
SoD Criteria have been met, then the JSC shall so notify BII in writing, which
notice shall be accompanied by a report containing Information in sufficient
detail to demonstrate that the SoD Criteria have been achieved for such
Compound. Upon BII’s receipt of such written notice and report, BII will
promptly inform its [**] (collectively, the “BII SoD Committee”) of the JSC’s
belief that the relevant Compound should be considered for SoD Approval and will
initiate a process for the BII SoD Committee to determine whether or not such
Compound should receive SoD Approval. For the avoidance of doubt, the JSC may
always decide to nominate a Compound prior to such Compound meeting all of the
SoD Criteria for the applicable Target Project provided the members of the JSC
of each Party mutually agree (without reference to the tie-breaking provisions
of Section 2.2.3 (Disagreement Resolution)).

(b)Within [**] of BII’s receipt of such report, the BII SoD Committee shall
notify the JSC in writing that SoD has occurred for the Target Project with
respect to such Compound (the “SoD Approval”), unless the BII SoD Committee,
acting reasonably and in good faith, has a scientific or commercial reason for
withholding SoD Approval for such Compound. In the event that the BII SoD
Committee has such a reason for withholding SoD Approval for a Compound, the BII
SoD Committee (or its designee) shall provide the JSC with written notice of its
reasons and a Remedial Plan with respect to such nominated Compound, which
Remedial Plan may include the performance or re-performance of Research
Activities that were set forth in the existing Research Plan or performance of
additional Research Activities not set forth in the existing Research Plan and,
if such Remedial Plan does include the performance of additional Research
Activities not set forth in the then existing Research Plan, shall include a
reasonable timeline for completing such additional Research Activities. Subject
to Section 3.2.2 (Extension), with respect to Research Activities set forth in
the Remedial Plan, Epizyme will bear the costs of conducting any such Research
Activities that were set forth in the existing Research Plan that were not
completed at the time the Compound

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was nominated for SoD Approval consideration pursuant to Section 4.2.2(a)
(Satisfaction of SoD Criteria), while the costs of any such Research Activities
not set forth in the existing Research Plan (i.e., additional Research
Activities) shall be at (i) BII’s cost if (A) the Remedial Plan requires that
BII perform any additional research activities with respect to any Compound, (B)
the entirety of the SoD Criteria were met for a Compound, but the BII SoD
Committee nevertheless withholds SoD Approval for such Compound or (C) the work
contemplated in the Remedial Plan is intended to produce results or data that is
not included in the SoD Criteria (and not already covered under the existing
Research Plan) and (ii) Epizyme’s costs if the JSC members mutually agreed
(without reference to the tie-breaking provisions of Section 2.2.3 (Disagreement
Resolution)) to nominate a Joint Compound for SoD Approval prior to such Joint
Compound meeting all of the SoD Criteria for the applicable Target Project.

(c)Upon completion of the Remedial Plan, the JSC shall notify BII in writing,
which notice shall be accompanied by a report containing Information in
sufficient detail to demonstrate that the Remedial Plan was completed. Upon
BII’s receipt of such written notice and report, BII will promptly inform the
BII SoD Committee. Within [**] of BII’s receipt of such report, the BII SoD
Committee will provide the JSC with SoD Approval with respect to the applicable
Compound, unless BII has further scientific or commercial reasons for
withholding SoD Approval for such Compound. If BII has further scientific or
commercial reasons for withholding SoD Approval, Epizyme shall continue to
perform in accordance with the Research Plan, including conducting any Research
Activities set forth in the Research Plan, and BII may solely decide to perform
any additional research related activities not set forth in the Research Plan
with respect to achieving SoD Approval for a Target Project or Compound, subject
to JSC oversight as applicable, and with BII having final decision making with
respect to any JSC decisions with respect to such additional research related
activities notwithstanding the provisions found in Section 2.2.3 (Disagreement
Resolutions).

4.3.Materials, Compound Transfer, and Customs Related Topics.

4.3.1Provision of Materials.

(a)In order to facilitate the Research Plan and Research Activities, each Party
shall, as set forth in the Research Plan, provide to the other Party certain
tangible biological and chemical materials, including Compounds (collectively,
“Materials”). All Materials provided by one Party to the other Party remain the
sole property of the supplying Party.

(b)Epizyme will not ship any Materials to BII without the prior written request
of BII and BII shall request such Materials through a written purchase order
issued to Epizyme, which will outline the specific amount and price (if any)
assigned to such Materials and the requested date of delivery, as agreed to
between the Parties. Epizyme shall monitor the synthesis, production and
shipment of Materials provided to BII under this Agreement. Epizyme shall share
information related to the synthesis, production and shipment of such Materials
and send such information to BII upon shipment of the applicable Materials to
BII. Epizyme agrees to reasonably cooperate with BII to determine whether
Epizyme may become an approved exporter in a country that has a Reciprocal
Preferential Trade Agreement with the E.U. in place, and therefore all Materials
meet preferential origin status. Epizyme shall

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declare the country of origin for each shipment of Materials and correspond and
fulfill the rules of origin for preferential trade with the E.U. Epizyme shall
use reasonable efforts to make available to BII any additional information
required by the relevant customs authorities to prove that each shipment of
Materials corresponds and fulfills the rules of origin for preferential trade
with the E.U. Epizyme shall undertake to provide legal authorizations for the
issue of preference certificates, in particular the status of the authorized
exporter under E.U. free trade agreements or a comparable status in other E.U.
preferential agreements (for example, the status as a registered exporter in the
general preferential system) and ensure the correct exercise of the obligations
resulting from the granting of the respective status. Following the expiration
or termination of this Agreement, Epizyme shall continue to support BII in
matters related to taxes and customs with respect to the Materials shipped to
BII pursuant to this Section 4.3.1 (Provision of Materials) for a period of [**]
following such expiration or termination.

4.3.2Provision of Protocols. In order to enable BII to perform Compound
synthesis or production as provided under this Agreement, Epizyme agrees to
transfer, and shall use reasonable efforts to cause its Third Party
manufacturers to transfer (including by using reasonable efforts to negotiate
contractual obligations for such Third Party manufacturers to do so under
agreements entered into following the Effective Date) the synthesis or
production protocols of all Compounds and relevant assay protocols to BII and to
provide reasonable assistance requested by BII to enable BII (or its Affiliate
or designated Third Party manufacturer, as applicable) to understand and
implement such synthesis or production protocols at the facilities designated by
BII. Such transfer shall be conducted at (a) BII’s expense, if related to the
BII Compound and (b) at BII’s and Epizyme’s expense, if related to the Joint
Compound, which shall be split in accordance with the Development Cost
allocation principles found in Section 5.2.1(b)(iv) (Allocation).

4.3.3Limitations. All Materials shall be used (a) only for the specific purpose
provided for in the applicable Research Plan and (b) solely under the control of
the receiving Party. Unless set forth in the Research Plan, the Materials may
not be used or delivered to or for the benefit of any Third Party without the
prior written consent of the supplying Party, and shall not be used in research
or testing involving human subjects, except as expressly contemplated in the
applicable Research Plan or in accordance with this Agreement. All Materials
shall be destroyed after completion of the permitted use. For clarity, Materials
provided by one Party to the other Party may continue to be used by the other
Party after the Research Period expires; provided that such receiving Party
continues to use such Materials for further research and Development efforts
covered under this Agreement and in accordance with any licenses granted under
ARTICLE 6 (Grant of Rights).

4.3.4DISCLAIMER. ANY MATERIALS ARE PROVIDED “AS IS” AND WITHOUT ANY
REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY
OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT
THE USE OF THE MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER
PROPRIETARY RIGHT OF ANY THIRD PARTY.

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4.3.5Research Compounds. In order for Epizyme to fully exercise the research
license granted to it by BII pursuant to Section 6.1.2 (Grant to Epizyme), BII
will transfer to Epizyme [**].

4.4.Exclusivity.

4.4.1[**].

(a)During the Term (other than in connection with a Party’s activities under
this Agreement), neither Party nor its Affiliates may, directly or indirectly,
(i) conduct research with the intent to identify or synthesize any [**]
Competing Product or (ii) Develop, Manufacture or Commercialize any [**]
Competing Product, in either case, until [**] for a Compound arising from a
Target Project directed to a [**] target under this Agreement; provided that
[**].

(b)Notwithstanding anything to the contrary in this Agreement, the restrictions
on BII and its Affiliates or Epizyme and its Affiliates in Section 4.4.1(a)
(Exclusivity – [**]) will not extend to any Third Party developing or
commercializing a product where such Third Party becomes an Affiliate of either
BII or Epizyme after the Effective Date as a result of a Change in Control of
BII or Epizyme or by any Affiliates of such Third Party that existed prior to
such Change in Control if (i) such product is being clinically developed or
commercialized by such Third Party or any of such Affiliates of such Third Party
prior to the date of such a Change in Control of BII or Epizyme or after such a
Change in Control of BII or Epizyme without any access to any BII Know-How or
Epizyme Know-How or Joint Know-How and any unpublished BII Patents or Epizyme
Patents or Joint Patents, (ii) a “firewall” of reasonable safeguards (including
physical separation, where appropriate) is put in place by BII or Epizyme and
such Third Party or any of such Affiliates of such Third Party between
individuals with access to Confidential Information of BII or Epizyme, BII
Know-How or Epizyme Know-How or Joint Know-How, and any unpublished BII Patents
or Epizyme Patents and Joint Patents, on the one hand, and the personnel
responsible for the development or commercialization of any such product, on the
other hand and (c) such development or commercialization of such product
continues or is undertaken without the use of any BII Know-How or Epizyme
Know-How or Joint Know-How and any unpublished BII Patents or Epizyme Patents or
Joint Patents after such Third Party becomes an Affiliate of BII or Epizyme.

4.4.2[**].

(a)During the Term (other than in connection with a Party’s activities under
this Agreement), neither Party nor its Affiliates may, directly or indirectly,
(i) conduct research with the intent to identify or synthesize any [**]
Competing Product or (ii) Develop, Manufacture or Commercialize any [**]
Competing Product, in either case, until [**] for a Compound arising from a
Target Project directed to a [**] target under this Agreement.

(b)Notwithstanding anything to the contrary in this Agreement, the restrictions
on BII and its Affiliates or Epizyme and its Affiliates in Section 4.4.2(a)
(Exclusivity – [**]) will not extend to any Third Party developing or
commercializing a product where such Third Party becomes an Affiliate of either
BII or Epizyme after the Effective

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Date as a result of a Change in Control of BII or Epizyme or by any Affiliates
of such Third Party that existed prior to such Change in Control if (i) such
product is being clinically developed or commercialized by such Third Party or
any of such Affiliates of such Third Party prior to the date of such a Change in
Control of BII or Epizyme or after such a Change in Control of BII or Epizyme
without any access to any BII Know-How or Epizyme Know-How or Joint Know-How,
and any unpublished BII Patents or Epizyme Patents or Joint Patents, (ii) a
“firewall” of reasonable safeguards (including physical separation, where
appropriate) is put in place by BII or Epizyme and such Third Party or any of
such Affiliates of such Third Party between individuals with access to
Confidential Information of BII or Epizyme, BII Know-How or Epizyme Know-How or
Joint Know-How, and any unpublished BII Patents or Epizyme Patents and Joint
Patents, on the one hand, and the personnel responsible for the development or
commercialization of any such product, on the other hand and (c) such
development or commercialization of such product continues or is undertaken
without the use of any BII Know-How or Epizyme Know-How or Joint Know-How and
any unpublished BII Patents or Epizyme Patents or Joint Patents after such Third
Party becomes an Affiliate of BII or Epizyme.

ARTICLE 5
Post-Research Responsibilities

5.1.BII Controlled Project.

5.1.1BII Products Report. Following [**] with respect to the BII Controlled
Project, BII (and its Affiliates), at its sole cost, shall have sole
decision-making authority and control over the BII Controlled Project, including
with respect to Developing, Manufacturing, pursuing Regulatory Approval for,
Commercializing and otherwise Exploiting (a) Compounds arising from the BII
Controlled Project (“BII Compounds”), (b) Products containing the BII Compounds
(“BII Products”) and (c) Diagnostic Products for the BII Compound and BII
Products. Prior to the [**] of BII Product, BII will provide Epizyme through its
Alliance Manager, within [**], with a written report summarizing BII’s, its
Affiliates’ and Sublicensees’ activities and results with respect to the
previous [**] period and the then-current expected activities for the next [**]
period for Development of the BII Compounds, the BII Product and Diagnostic
Products for the BII Compound and BII Product in the Field in the Territory
(such report, the “BII Products Report”).

5.1.2BII Diligence. BII, itself or through its Affiliates or Sublicensees, shall
use Commercially Reasonable Efforts to (a) Develop and pursue Regulatory
Approval for at least one BII Product and (b) Commercialize one BII Product in
the Territory where Regulatory Approval is received for such Product. With
respect to certain countries, the Parties understand that due to pricing or
reimbursement limitations, parallel trade and importation issues or other market
related considerations that may arise, it may become impractical, unprofitable,
undesirable or unreasonable to launch and sell BII Product in such countries
alone or when considering potential impacts on other countries where BII Product
shall be Commercialized and, in all such like instances, BII shall be entitled
to decide to not Commercialize BII Product in such countries and not be in
breach of its Commercially Reasonable Efforts and other obligations under this
Section 5.1.2 (BII Diligence).

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5.2.Jointly Controlled Project.

5.2.1Development Responsibilities and Expenses.

(a)General. Unless otherwise agreed to by the JSC in the Joint Development Plan
and Budget pursuant to Section 5.2.1(b) (Joint Development Plan and Budget),
upon [**] with respect to the Jointly Controlled Project, whichever occurs
first, BII shall have operational responsibility for the Jointly Controlled
Project.

(b)Joint Development Plan and Budget.

(i)Initial Development Plan and Budget. Subject to Section 5.2.1(a) (Jointly
Controlled Project – General), with respect to Developing, Manufacturing and
seeking Regulatory Approval for (A) Compounds arising from the Jointly
Controlled Project (“Joint Compounds”), (B) Products containing Joint Compounds
(“Joint Products”) and (C) Diagnostic Products for the Joint Compound or Joint
Product, the JSC shall allocate such responsibilities between the Parties
pursuant to a [**] rolling Development plan and budget approved by the JSC (such
plan and budget, together with all revisions and amendments thereto, the “Joint
Development Plan and Budget”); provided that BII shall be solely responsible for
pursuing Regulatory Approval for Joint Products and Diagnostic Products for
Joint Compounds or Joint Products if such Regulatory Approvals relate solely to
an ROW country or countries. Without limitation, the Joint Development Plan and
Budget shall set forth, among other things, (1) the specific Clinical Trials to
be Conducted, including those that are committed and those that are conditioned
upon the results of ongoing Clinical Trials, (2) the anticipated timelines for
such Clinical Trials and (3) the Clinical Trial activities to be assigned to
each Party, with respect to (1)-(3), for the Joint Product in the Territory. The
Parties shall not conduct any Development, Manufacturing or Regulatory
Activities with respect to the Joint Compounds, Joint Products or Diagnostic
Products for Joint Compounds or Joint Products that are inconsistent with the
Joint Development Plan and Budget. In the event the JSC has been disbanded
pursuant to Section 2.1.4 (Disbandment), the Joint Development Plan and Budget
will terminate (except as provided for under any transition related plans), and
BII will be responsible for preparing and providing Epizyme with [**] reports
with respect to the Joint Product that correspond with the reporting provisions
found in Section 5.1.1 (BII Products Report) of this Agreement, mutatis
mutandis.

(ii)Revisions. The JSC shall revise the Joint Development Plan and Budget [**]
so that immediately following such revision the Joint Development Plan and
Budget always sets forth a [**] rolling Development plan and budget for the
Joint Compound and Joint Product in the Territory. The budget for the [**]
period (the “[**]”) of the Joint Development Plan and Budget shall be firm. In
connection with making [**] revisions to the Joint Development Plan and Budget
pursuant to this Section 5.2.1(b)(ii) (Revisions), unless the Parties otherwise
mutually agree, the JSC may not increase the budget for such activities (A) with
respect to the [**] (which had previously been [**] (the “[**]”) in the previous
Joint Development Plan and Budget), by more than [**] percent ([**]%) of the
budget set forth in the previous Joint Development Plan and Budget for such
months and (B) with respect to the [**] period (which had previously been [**]
(the “[**]”) in the previous Joint Development Plan and Budget), by more than
[**] percent ([**]%) of the budget set forth in the

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previous Joint Development Plan and Budget for such [**]. The JSC shall act in
good faith when establishing the budget for the Joint Development Plan and
Budget. In the event the JSC decides to revise the Joint Development Plan and
Budget prior to the expiration of the then-current [**] period (i.e., before
[**] revision is required) (each such revision, an “Off-Cycle Amendment”), then
the [**] rolling period for the Joint Development Plan and Budget shall commence
anew as of the effective date of the Off-Cycle Amendment, but such Off-Cycle
Amendment shall otherwise remain subject to the terms of this Section
5.2.1(b)(ii) (Revisions), including that: (1) the Joint Development Plan and
Budget shall be revised [**]from the effective date of the Off-Cycle Amendment
so that it always sets forth a [**] rolling Development plan and budget for the
Joint Compound and Joint Product in the Territory; (2) the JSC may not increase
the budget for any [**] that were previously included in the [**], unless the
Parties, acting through their JSC members, otherwise mutually agree (without
reference to the tie-breaking provisions of Section 2.2.3 (Disagreement
Resolution)); (3) the JSC may not increase the budget by more than [**] percent
([**]%) for any [**] that were previously included in the [**] and (4) the JSC
may not increase the budget by more than [**] percent ([**]%) for any [**] that
were previously included in the [**].

(iii)Other Amendments. Subject to the budgeting restrictions set forth in
Section 5.2.1(b)(ii) (Revisions), the JSC shall review the Joint Development
Plan and Budget [**] to determine if any non-budgetary amendments are necessary
to the Joint Development Plan and Budget, and shall approve any such amendments
to the Joint Development Plan and Budget.

(iv)Allocation. Sixty-five percent (65%) of the Development Costs associated
with Developing, Manufacturing and seeking Regulatory Approval for Joint
Compounds and Joint Products shall be allocated to BII and thirty-five percent
(35%) of such Development Costs shall be allocated to Epizyme; provided that (1)
to the extent any such Development Costs relate to activities undertaken solely
to obtain Regulatory Approval in the U.S., the Parties shall equally share such
costs (50:50) and (2) to the extent any such Development Costs relate to
activities undertaken solely to obtain Regulatory Approval in a ROW country or
countries, BII shall be solely responsible for all such costs.

(c)JSC Development Responsibility.

(i)United States. The JSC will monitor the Development of Joint Products for the
United States and will serve as the primary decision-making forum with respect
to significant decisions affecting the Development of the Joint Product for the
United States; provided that each Party undertaking such Development activities
will have control over the day-to-day conduct of such activities. Each Party
will submit to the JSC for its review, within [**], a report with respect to its
Development activities for the Joint Product for the United States undertaken by
such Party during [**].

(ii)ROW. The JSC will monitor the Development of the Joint Product for the ROW
and will serve as a forum for the Parties with respect to discussing matters
affecting the Development of the Joint Product for the ROW and U.S. and
Information sharing with respect thereto. In connection with the foregoing, BII
will submit to the JSC for its review, within [**], a report with respect to its
Development activities for the Joint Product for the ROW during [**].

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(d)Reporting and Reconciliation Payments; Overruns.

(i)Reporting; Audit. Each Party shall report to the other, within [**], the
actual Development Costs incurred by such Party with respect to the Joint
Compound and Joint Product [**]. Such report shall specify, in reasonable
detail, such Development Costs. Within [**], BII shall reconcile all Development
Costs incurred [**] by the Parties and provide Epizyme with written notice of
the results of such reconciliation. Based on the results of such reconciliation,
a payment shall be made by one Party to the other as may be necessary to effect
the division of Development Costs set forth in Section 5.2.1(b)(iv)
(Allocation), which payment shall be made within [**] following Epizyme’s
receipt of the reconciliation notice. If either Party believes, in good faith,
that the Development Costs reported by the other Party [**] are not accurate,
then the Parties shall meet and discuss the alleged inaccuracy and attempt to
come to resolution with respect thereto. In the event the Parties are unable to
resolve the alleged inaccuracy, the Party alleging the inaccuracy will have the
right to perform an audit of the other Party’s Development Costs pursuant to the
provisions of Section 7.10 (Audit; Audit Dispute), mutatis mutandis.

(ii)FTE Records and Calculations. Each Party shall record and account for its
FTE effort with respect to Joint Products in the Territory to the extent that
such FTE efforts are included in Development Costs that are shared under this
Agreement. Each Party shall calculate and maintain records relating to FTE
efforts incurred by it in a manner consistent with the provisions found within
this Agreement and generally as used for other products developed by such Party.

(iii)Development Overruns. If the Development Costs incurred by a Party for
Development activities exceed the amounts set forth in the Joint Development
Plan and Budget by more than [**] percent ([**]%) (calculated for all costs
incurred over the [**] (as such may be adjusted pursuant to Section
5.2.1(b)(ii)) for all budgeted activities), such excess Development Costs (each,
a “Development Overrun”) shall be borne by the Party responsible for performing
or causing to be performed such activities and such Development Overrun shall be
excluded from the division of Development Costs set forth in Section
5.2.1(b)(iv) (Allocation); provided that, if such Development Overrun was
outside the reasonable control of, and not attributable to a failure to use
Commercially Reasonable Efforts by, the Party responsible for such Development
Overrun, or did not result from the failure of such Party to adequately
supervise a Third Party performing such activities, then the Party incurring
such Development Overrun may petition the JSC to have such Development Overrun
included in the division of Development Costs and shared by the Parties pursuant
to Section 5.2.1(b)(iv) (Allocation) and, only if the Parties, acting through
their JSC representatives, mutually agree (without reference to the tie-breaking
provisions of Section 2.2.3 (Disagreement Resolution)) that such Development
Overrun should be included in the division of Development Cost (without BII
exercising its tie-breaking authority pursuant to Section 2.2.3 (Disagreement
Resolution)), will such Development Overrun be shared by the Parties pursuant to
Section 5.2.1(b)(iv) (Allocation).

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(e)Development Diligence. Each Party, itself or through its Affiliates or
permitted Contractors or Sublicensees, shall use Commercially Reasonable Efforts
to perform the activities allocated to it under the Joint Development Plan and
Budget, including by Developing and pursuing Regulatory Approval for Joint
Products as set forth in the Joint Development Plan and Budget. For the
avoidance of doubt, BII shall be solely responsible for submitting all Drug
Approval Applications to Regulatory Authorities for Regulatory Approvals, and
any and all such Drug Approval Applications that have received Regulatory
Approval shall be solely owned by and held in BII’s name.

5.2.2Commercialization Responsibilities and Expenses.

(a)Joint Commercialization Plan and Budget.

(i)Initial Commercialization Plan and Budget. With respect to the
Commercialization of Joint Products throughout the U.S., the JSC shall allocate
such responsibilities between the Parties pursuant to a [**] rolling
Commercialization plan and budget approved by the JSC (such plan and budget,
together with all revisions and amendments thereto, the “Joint Commercialization
Plan and Budget”), which shall be agreed to [**] of a Joint Product in the
United States. Without limitation, the Joint Commercialization Plan and Budget
shall set forth, among other things, [**]. Notwithstanding the foregoing, if the
JSC determines to adopt a Joint Commercialization Plan and Budget [**] of the
Joint Product, then the JSC may determine to include in such Joint
Commercialization Plan and Budget, [**] budget (rather than a [**] rolling
budget) and such Joint Commercialization Plan and Budget need not include all of
the items set forth in ensuing subclauses (A)-(N), as the JSC deems appropriate.
The JSC shall, at all times, except as provided elsewhere in this Agreement,
endeavor to split Commercialization responsibilities with respect to the Joint
Compound and Joint Product in the United States equally between the Parties,
including 50:50 participation in co-promotion, Detailing and medical science
liaison activities. [**] of Joint Product in the U.S., Epizyme shall have
established a commercial team composed of qualified marketing and other
commercial-oriented employees, knowledgeable and experienced in the sale of
oncology pharmaceutical products, and [**] of Joint Product in the U.S., Epizyme
shall have established a sales force organization, sales representatives and a
medical science liaison organization of suitable size, composition and with
relevant oncology product experience to perform the anticipated Detailing,
medical education and other responsibilities required in the then current Joint
Commercialization Plan and Budget. Unless otherwise agreed to by the JCC, at
least [**] percent ([**]%) of all such sales force representatives and medical
science liaisons performing Epizyme’s delegated activities shall be Epizyme
employees (or any such lesser percentage if BII or its Affiliate(s) employs such
lesser percentage of its sales force representatives and medical science
liaisons in performing BII’s delegated activities), and all such representatives
shall be fully trained and qualified, based on the same criteria applicable by
BII to the qualification and training of its sales representatives generally,
[**] of Product in the U.S., unless the JSC provides otherwise through the Joint
Commercialization Plan and Budget. The Parties shall not conduct any
Commercialization activities for the Joint Compound and Joint Product
inconsistent with the Joint Commercialization Plan and Budget. BII shall be
solely responsible for Commercializing the Joint Product in the ROW.

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(ii)Revisions. The JSC shall revise the Joint Commercialization Plan and Budget
[**] so that immediately following such revision the Joint Commercialization
Plan and Budget always sets forth a [**] rolling Commercialization plan and
budget for the Joint Compound and Joint Product in the Territory. The budget for
the [**] of the Joint Commercialization Plan and Budget shall be firm. In
connection with making [**] revisions to the Joint Commercialization Plan and
Budget pursuant to this Section 5.2.2(a)(ii) (Revisions), unless the Parties
otherwise mutually agree, the JSC may not increase the budget for such
activities (A) with respect to the [**], by more than [**] percent ([**]%) of
the budget set forth in the previous Joint Commercialization Plan and Budget for
such [**] and (B) with respect to the [**], by more than [**] percent ([**]%) of
the budget set forth in the previous Joint Commercialization Plan and Budget for
such months. The JSC shall act in good faith when establishing the budget for
the Joint Commercialization Plan and Budget. In the event the JSC decides to
make an Off-Cycle Amendment to the Joint Commercialization Plan and Budget prior
to the expiration of then then-current [**] period (i.e., before [**] revision
is required), then the [**] rolling period for the Joint Commercialization Plan
and Budget shall commence anew as of the effective date of the Off-Cycle
Amendment, but such Off-Cycle Amendment shall otherwise remain subject to the
terms of this Section 5.2.2(a)(ii) (Revisions), including that: (1) the Joint
Commercialization Plan and Budget shall be revised [**] from the effective date
of the Off-Cycle Amendment so that it always sets forth a [**] rolling
Commercialization plan and budget for the Joint Compound and Joint Product in
the United States; (2) the JSC may not increase the budget for any [**] that
were previously included in the [**] unless the Parties, acting through their
JSC members, otherwise mutually agree (without reference to the tie-breaking
provisions of Section 2.2.3 (Disagreement Resolution)); (3) the JSC may not
increase the budget by more than [**] percent ([**]%) for any [**] that were
previously included in the [**]; and (4) the JSC may not increase the budget by
more than [**] percent ([**]%) for any [**] that were previously included in the
[**].

(iii)Other Amendments. Subject to the budgeting restrictions set forth in
Section 5.2.2(a)(ii) (Revisions), the JSC shall review the Joint
Commercialization Plan and Budget [**] to determine if any non-budgetary
amendments are necessary to the Joint Commercialization Plan and Budget and
shall approve any such amendments to the Joint Commercialization Plan and
Budget.

(iv)Allocation. Epizyme shall receive fifty percent (50%) of all Net Sales and
bear fifty percent (50%) of all Allowable Expenses resulting from
Commercialization of Joint Products in the United States and BII shall receive
fifty percent (50%) of all Net Sales and bear fifty percent (50%) of all
Allowable Expenses resulting from Commercialization of Joint Products in the
United States.

(b)JSC Commercialization Responsibility.

(i)United States. The JSC will monitor the Commercialization of Joint Products
for the United States and will serve as the primary decision-making forum with
respect to significant decisions affecting the Commercialization of the Joint
Product for the United States; provided that, each Party undertaking such
Commercialization activities will have control over the day-to-day conduct of
such activities. Each Party will submit to the JSC for its review, within [**],
a report with respect to its Commercialization activities for the Joint Product
for the United States during the previous [**].

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(ii)ROW. The JSC will monitor the Commercialization of the Joint Product for the
ROW and will serve as a forum for the Parties with respect to discussing matters
affecting the Commercialization of the Joint Product for the ROW and U.S. and
Information sharing with respect thereto. In connection with the foregoing, BII
will submit to the JSC for its review, within [**], a report with respect to its
Commercialization activities for the Joint Product for the ROW during the
previous [**].

(c)Profit Share. In furtherance of the 50:50 allocation of Net Sales and
Allowable Expenses as set forth in Section 5.2.2(a) (Joint Commercialization
Plan and Budget):

(i)Reports and Payments in General. Each Party shall report to the other Party,
within [**] after the end of each Calendar Quarter, the actual Net Sales and
Allowable Expenses incurred by such Party with respect to Joint Products in the
U.S. during such Calendar Quarter. Such report shall specify in reasonable
detail all deductions allowed in the calculation of such Net Sales and all
expenses included in Allowable Expenses. Within [**] after the end of each
Calendar Quarter, BII shall reconcile all Net Sales and Allowable Expenses to
ascertain whether there is a Net Profit or Net Loss and provide Epizyme with
written notice of the results of such reconciliation. Based on the results of
such reconciliation, payments shall, subject to Section 5.2.2(c)(iv) (Overruns),
be made as follows: (A) if there is a Net Profit for such Calendar Quarter, then
BII shall pay to Epizyme an amount equal to fifty percent (50%) of the Net
Profit for such Calendar Quarter; or (B) if there is a Net Loss for such
Calendar Quarter, then the Party that has borne less than fifty percent (50%) of
the aggregate Allowable Expenses incurred by the Parties during such Calendar
Quarter shall make a reconciling payment to the other Party so that each Party
bears fifty percent (50%) of the aggregate Allowable Expenses during such
Calendar Quarter. Such payments shall be made within [**] following Epizyme’s
receipt of the reconciliation notice. If either Party believes, in good faith,
that the Net Sales or Allowable Expenses reported by the other Party for a
Calendar Quarter are not accurate, then the Parties shall meet and discuss the
alleged inaccuracy and attempt to come to resolution with respect thereto. In
the event the Parties are unable to resolve the alleged inaccuracy, the Party
alleging the inaccuracy will have the right to perform an audit of the other
Party’s Net Sales and Allowable Expenses pursuant to the provisions of Section
7.10 (Audit; Audit Dispute), mutatis mutandis.

(ii)FTE Records and Calculations. Each Party shall record and account for its
FTE effort with respect to Joint Products in the U.S. to the extent that such
FTE efforts are included in Allowable Expenses that are shared under this
Agreement. Each Party shall calculate and maintain records relating to FTE
efforts incurred by it in a manner consistent with the provisions found within
this Agreement and generally as used for other products developed by such Party.
Each Party shall charge the FTE Rate for all FTEs who perform Commercialization
activities encompassed within the definition of Allowable Expenses, except with
respect to those activities encompassed within the definition of Sales and
Marketing Costs. The FTE Rate(s) for activities encompassed within the
definition of Sales and Marketing Costs shall be discussed by the JSC and the
representatives of the Parties shall use good faith efforts to mutually agree on
such FTE Rate(s) to be applied; provided that, in the event that the
representatives of the Parties are unable to mutually agree on an FTE Rate(s),
or the JSC has been disbanded under Section 2.1.4 (Disbandment) due to a Change
in Control of Epizyme, then

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the Parties shall use the FTE Rate set forth in Schedule 1.81. Notwithstanding
the foregoing, the Allowable Expenses for sales representatives co-promoting the
Joint Product in the U.S. shall be based on a fixed cost for Details in the
primary or secondary position for similar prescriber specialties, and
established by the JSC (or by BII in the event the JSC has been disbanded under
Section 2.1.4 (Disbandment) due to a Change in Control of Epizyme) based on
industry standard comparable benchmarks.

(iii)Last Calendar Quarter. No separate payment shall be made for the last
Calendar Quarter in any Calendar Year. Instead, at the end of each such Calendar
Year, a final reconciliation shall be conducted by comparing the share of Net
Profit or Net Loss to which a Party is otherwise entitled for such Calendar Year
against the sum of all amounts (if any) previously paid or retained by such
Party for prior Calendar Quarters during such Calendar Year, and the Parties
shall make reconciling payments to one another no later than [**] after the end
of such Calendar Quarter, if and as necessary to ensure that each Party receives
for such Calendar Year its share of Net Profits and bears its share of Net
Losses in accordance with Section 5.2.2(a)(iv) (Allocation).

(iv)Commercialization Overruns. If the Allowable Expenses incurred by a Party
for Commercialization activities exceed the amounts set forth in the Joint
Commercialization Plan and Budget by more than [**] percent ([**]%) (calculated
for all costs incurred over the [**] (as such may be adjusted on account of an
Off-Cycle Amendment pursuant to Section 5.2.2(a)(ii) (Revisions)) for all
budgeted activities), such excess Allowable Expenses (each, a “Commercialization
Overrun”) shall be borne by the Party responsible for performing or causing to
be performed such activities and shall be excluded from “Allowable Expenses”
hereunder; provided that, if such Commercialization Overrun was outside the
reasonable control of, and not attributable to a failure to use Commercially
Reasonable Efforts by, the Party responsible for such Commercialization Overrun,
or did not result from the failure of such Party to adequately supervise a Third
Party performing such activities, then the Party incurring such
Commercialization Overrun may petition the JSC to have such Commercialization
Overrun included in the division of Allowable Expenses and shared by the Parties
pursuant to Section 5.2.2(a)(iv) (Allocation) and, only if the Parties, acting
through their JSC representatives, mutually agree (without reference to the
tie-breaking provisions of Section 2.2.3 (Disagreement Resolution)) that such
Commercialization Overrun should be included in the division of Allowable
Expenses (without BII exercising its tie-breaking authority pursuant to Section
2.2.3 (Disagreement Resolution)), will such Commercialization Overrun be shared
by the Parties pursuant to Section 5.2.2(a)(iv) (Allocation).

(d)Commercialization Diligence. BII, with respect to the ROW, and each Party,
with respect to the United States, itself or through its Affiliates or permitted
Contractors or Sublicensees, shall use Commercially Reasonable Efforts to
Commercialize Joint Products in the Territory where Regulatory Approval is
received for such Product. Each Party will use Commercially Reasonable Efforts
to perform the activities allocated to it under the Joint Commercialization Plan
and Budget. With respect to certain countries, the Parties understand that due
to pricing or reimbursement limitations, parallel trade and importation issues
or other market related considerations that may arise, it may become
impractical, unprofitable, undesirable or unreasonable to launch and sell Joint
Product(s) in such countries alone or when considering potential impacts on
other countries where Joint Product(s)

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shall be Commercialized and, in all such like instances, BII shall be entitled
to decide to not Commercialize Joint Product(s) in such countries and not be in
breach of its Commercially Reasonable Efforts and other obligations under this
Section 5.2.2(d) (Commercialization Diligence).

(e)Delegation to JCC. For clarity, the JSC may delegate any or all of its
responsibilities under Section 5.2.2 (Commercialization Responsibilities and
Expenses) to the JCC pursuant to Section 2.4 (Working Groups), but, in such
event, the JSC will remain responsible for approving the Joint Commercialization
Plan and Budget established by the JCC, including all revisions and any other
amendments thereto.

5.2.3Adverse Actions. In the event that Epizyme reasonably believes, in good
faith, that any proposed activity by BII with respect to a Joint Product in an
ROW country could adversely affect the Development or Commercialization of a
Joint Product in the U.S., then Epizyme shall inform the JSC in writing of its
concerns and the JSC shall promptly meet and no later than at the next regularly
scheduled JSC meeting, and consult on such matters to determine whether BII
should make any changes to its proposed activities. Notwithstanding the
foregoing, in all instances, BII shall have final decision-making authority with
respect to such ROW Development or Commercialization activities and whether to
implement or not implement any potential changes pursuant to Section 2.2.3
(Disagreement Resolution).

5.2.4Booking of Sales; Distribution. BII and its Affiliates will have the sole
right in setting prices, determining discounts, contracting with Third Parties,
invoicing and booking sales (in relation to gross sales and Net Sales),
warehousing and distributing Joint Products in the Territory, and to perform or
cause to be performed all related services, subject to the JSC’s role in
determining the terms thereof with respect to the Joint Product in the United
States pursuant to Section 5.2.2(b)(i) (JSC Commercialization Responsibility –
United States), but always subject to Section 2.2.3 (Disagreement Resolution)
where BII has final decision making powers. BII and its Affiliates will handle
all returns, recalls or withdrawals, order processing, invoicing, collection,
distribution and inventory management with respect to Joint Products in the
Territory.

5.2.5Epizyme Opt-Out. With respect to the Joint Product, Epizyme may, [**]
included in such Joint Product, upon prior written notice to BII (such notice,
the “Opt-Out Notice”), elect to cease its participation in the Development and
Commercialization of such Joint Product (for clarity, if elected [**], Epizyme
shall continue to perform its obligations with respect to the Research
Activities under the Research Plan and those obligations contained in ARTICLE 2
(Collaboration Management), ARTICLE 3 (Research Plan; Research Period) and
ARTICLE 4 (Research Program) of this Agreement that relate to Joint Product).
The Epizyme Opt-Out Notice shall become effective (a) upon [**] prior written
notice, if given [**], (b) upon [**] prior written notice, if given [**] or (c)
upon [**] prior written notice, if given [**]; provided, however, that Epizyme
may only cease its participation in the Development and Commercialization of the
Joint Product during the [**] period [**] if BII agrees and provides its prior
written consent that Epizyme may opt-out as aforesaid. Epizyme may always
provide an Opt-Out Notice to BII at any time after [**]. In the event Epizyme
does provide BII with an Opt-Out Notice as aforesaid, once effective: (i)
Epizyme shall have no further obligation to, and shall cease to, perform
Development activities (other than any Research Activities to be performed

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under the Research Plan if such Opt-Out Notice is provided [**] as set forth in
the first sentence of this Section 5.2.5 (Epizyme Opt-Out)) and
Commercialization activities with respect to such Joint Compound or Joint
Product in the United States, which cessation will occur pursuant to a mutually
agreed to transition plan that will wind-down Epizyme’s performance of (A)
Development activities as soon as reasonably practicable following the effective
date of the opt-out (subject to the requirement that Epizyme continue to perform
its obligations with respect to the Research Activities under the Research Plan
if the Opt-Out Notice is provided prior to [**] as set forth in the first
sentence of this Section 5.2.5 (Epizyme Opt-Out)) and using reasonable efforts
to avoid unnecessary Development disruptions and (B) Commercialization
activities over a period of not more than [**] following the effective date of
the opt-out and using reasonable efforts to avoid unnecessary Commercialization
disruptions, and for the avoidance of doubt, upon the completion of the Epizyme
activities described in (A)-(B) and reflected in the transition plan, the
license grants under Section 6.1.1 shall expire and terminate; (ii) Epizyme
shall remain responsible for one hundred percent (100%) of its share of
Allowable Expenses that were (A) actually incurred prior to the effective date
of the Opt-Out Notice or (B) if not actually incurred prior to the effective
date of the Opt-Out Notice, are nevertheless Committed Costs; (iii) Epizyme
shall remain responsible for one hundred percent (100%) of its share of
Development Costs that were (A) actually incurred prior to the effective date of
the Opt-Out Notice or (B) if not actually incurred prior to the effective date
of the Opt-Out Notice, are nevertheless Committed Costs; and (iv) the 50:50
profit and cost share set forth in Section 5.2.2 (Commercialization
Responsibilities and Expenses) with respect to Net Sales of Joint Products in
the U.S. shall cease and, instead, BII shall pay Epizyme a royalty based on
future Net Sales of such Joint Product in the U.S. as follows (the “Opt-Out
Royalties”):

Timing of Opt-Out Notice

Royalty Rate

If the Opt-Out Notice is given [**] with respect to such Joint Product

BII Controlled Project royalty rates (as set forth in Section 7.4.1) shall
apply.

If the Opt-Out Notice is [**] with respect to such Joint Product

BII Controlled Project royalty rates (as set forth in Section 7.4.1) shall
apply, plus [**] percent ([**]%)

If the Opt-Out Notice is [**], with respect to such Joint Product

BII Controlled Project royalty rates (as set forth in Section 7.4.1) shall
apply, plus [**] percent ([**]%)

If the Opt-Out Notice is [**]

BII Controlled Project royalty rates (as set forth in Section 7.4.1) shall
apply, plus [**] percent ([**]%)

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For the avoidance of doubt, BII’s payment of Opt-Out Royalties shall be governed
by Sections 7.4.2 (Royalty Term), 7.4.3 (Reductions), 7.5 (Royalty Payments and
Reports), 7.6 (Mode of Payment; Offsets), 7.7 (Taxes; Withhold Taxes), 7.8
(Interest on Late Payments), 7.9 (Financial and Other Records), 7.10 (Audit;
Audit Dispute) and 7.11 (Confidentiality).

5.3.Manufacturing; Technology Transfer.

5.3.1Supply Plans. The JSC shall establish the pre-clinical, clinical and
commercial supply strategy for Joint Compounds, Joint Products and Diagnostic
Products for Joint Compounds or Joint Products in the United States, including
Manufacturing plans with respect thereto. BII or its Affiliates, or its or their
Contractors or Sublicensees. shall Manufacture (a) all pre-clinical and clinical
requirements of Joint Compounds, Joint Products (including placebo or other
comparators) and Diagnostic Products for Joint Compounds or Joint Products, with
respect to each, for use by the Parties in connection with Development
activities as contemplated in the Joint Development Plan and Budget and (b) all
commercial requirements of Joint Compounds, Joint Products and Diagnostic
Products for Joint Compounds or Joint Products, with respect to each, for use by
the Parties in connection with Commercialization activities as contemplated in
the Joint Commercialization Plan and Budget, with respect to (a)-(b), in
accordance with the JSC-approved supply strategy and Manufacturing plans. If,
pursuant to the Joint Development Plan and Budget, the JSC appoints Epizyme to
Conduct a Clinical Trial for a Joint Product, then BII and Epizyme shall
promptly enter into a (i) supply agreement for the supply and Manufacture of the
Joint Compounds, Joint Products or Diagnostic Products for Joint Compounds or
Joint Products that are the subject of such Clinical Trial and (ii) a quality
agreement related to such Manufacture and supply, which will set forth the
applicable quality, release and approval procedures.

5.3.2Manufacture. All Compounds and Products (and any applicable placebos or
other comparators) Manufactured and delivered by BII or its Affiliates, or its
or their Contractors or Sublicensees, pursuant to Section 5.3.1 (Supply Plans)
shall be Manufactured, transported, stored and handled in accordance with GMP
and all other Applicable Laws.

5.4.Recalls. BII or its Affiliates shall use reasonable efforts to notify
Epizyme promptly following its determination that any event, incident, or
circumstance has occurred that may result in the need for a recall, market
suspension, or market withdrawal of a Joint Product in the Territory and shall
include in such notice the reasoning behind such determination, and any
supporting facts. BII (or its Affiliates or Sublicensee) shall have the right to
make the final determination whether to voluntarily implement any such recall,
market suspension or market withdrawal in the Territory. If a recall, market
suspension, or market withdrawal is mandated by a Regulatory Authority in the
Territory, then BII (or its Affiliates or its Sublicensee) shall initiate such a
recall, market suspension, or market withdrawal in compliance with Applicable
Law. For all recalls, market suspensions or market withdrawals undertaken
pursuant to this Section 5.4 (Recalls), BII (or its Affiliates or Sublicensee)
responsible for the recall, market suspension, or market withdrawal shall be
solely responsible for the execution thereof and Epizyme shall reasonably
cooperate in all such recall efforts. Subject to ARTICLE 12 (Indemnity), (a) in
the event that a recall, market suspension or market withdrawal resulted from a
Party’s or its Affiliate’s breach of its obligations hereunder, or from such
Party’s or its Affiliate’s negligence

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or willful misconduct, such Party shall bear the expense of such recall, market
suspension or market withdrawal, (b) with respect to any other recall, market
suspension or market withdrawal of the Joint Product in the U.S., the expenses
incurred by the Parties as a result of such recall, market suspension or market
withdrawal shall be included in Allowable Expenses hereunder and resolved
pursuant to Section 5.2.2(a)(iv) (Allocation) and (c) with respect to any
recall, market suspension or market withdrawal not covered by clause (a) or (b),
BII shall be responsible for all costs of such recall, market suspension or
market withdrawal.

ARTICLE 6
Grant of Rights

6.1.Grant to Epizyme. Subject in the first instance to Section 6.2 (Grant to
BII), and subject to Section 6.4 (Sublicenses), BII (on behalf of itself and its
Affiliates) hereby grants back to Epizyme and solely to those Epizyme Affiliates
whereby, consistent with the definitional guidance provided under Section 1.2
(Definition of “Affiliate”), Epizyme controls such Person that is an Affiliate
of Epizyme, but no licenses are granted to any Epizyme Affiliates whereby the
Person that is an Affiliate of Epizyme either controls Epizyme or is under
common control with Epizyme:

6.1.1a non-exclusive, royalty-free and non-transferable (except in accordance
with Section 14.4 (Assignment)) license under the Collaboration Technology to
(a) conduct the Research Activities assigned to it under the Research Plan and
(b) Develop, Manufacture, Commercialize and otherwise Exploit the Joint Compound
and Joint Product in accordance with the Joint Development Plan and Budget and
Joint Commercialization Plan and Budget in the United States; and

6.1.2a limited, non-exclusive, royalty-free, non-transferable (except pursuant
to Section 14.4 (Assignment)), research license to use BII Research Compounds
solely in Counter Screens for the sole purpose to identify inhibitors of other
helicase targets and histone acetyl transferase targets other than a [**] target
or [**] target.

6.2.Grant to BII. In the first instance and prior to any of the license grants
in  Section 6.1 (Grant to Epizyme), and subject to Section 6.4 (Sublicenses),
Epizyme (on behalf of itself and its Affiliates) hereby grants to BII and its
Affiliates:

6.2.1an exclusive, royalty-free and non-transferable (except in accordance with
Section 14.4 (Assignment)) license under the Epizyme Technology and Epizyme’s
interest in Joint Technology for the purpose of conducting the Research
Activities assigned to it under the Research Plan and with respect to Compounds
and Products in the Field and in the Territory; and

6.2.2an exclusive (even with respect to Epizyme and its Affiliates),
royalty-bearing and non-transferable (except in accordance with Section 14.4
(Assignment)) license under the Epizyme Technology and Epizyme’s interest in
Joint Technology to Develop, Manufacture, Commercialize and otherwise Exploit in
the Field and in the Territory Compounds and Products, including (i) the BII
Compound and BII Product and (ii) the Joint Compound and Joint Product.

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6.3.Negative Covenant. With respect to the licenses granted to Epizyme under
Section 6.1.1(b), BII hereby covenants that it shall not grant any similar
licenses to Third Parties other than to those who are considered Contractors
pursuant to Section 6.5 (Contractors) of this Agreement.

6.4.Sublicenses. Either Party may sublicense the rights granted to it in Section
6.1 (Grant to Epizyme) or Section 6.2 (Grant to BII) as follows:

6.4.1(a) with respect to the rights granted to Epizyme in Section 6.1.1 or
Section 6.1.2 and (b) with respect to the rights granted to BII in Section
6.2.1, to Third Parties engaged by a Party pursuant to Section 6.5
(Subcontracting);

6.4.2with respect to the rights granted BII in Section 6.2.2, through multiple
tiers, to Third Parties (each, a “Sublicensee”);

6.4.3any sublicense granted by a Party to a Contractor or Sublicensee pursuant
to this Section 6.4 (Sublicenses) shall be granted pursuant to a written
agreement that is consistent with the terms and conditions of this Agreement, a
copy of which shall be provided to the non-granting Party within [**] of
execution. The Party granting the sublicense shall remain liable for any breach
by a Contractor or Sublicensee that would constitute a breach of this Agreement.

6.5.Subcontracting. BII shall have the right to subcontract any of its
activities to a Contractor; provided that BII will remain responsible and liable
for the actions of its Contractors, including with respect to the achievement of
Milestone Events and breaches of this Agreement. Epizyme shall have the right to
subcontract any of its activities: (i) under the Research Plan to a Contractor
without BII’s consent, unless such activities relate to (A) Compound synthesis
directed toward in vivo safety studies, (B) the performance of in vivo safety
studies (including histology analysis and CV assessment) or (C) assay
development using human tissue, each of which ((A)-(C)) require BII’s prior
written consent (not to be unreasonably withheld or delayed) or (ii) under the
Joint Development Plan and Budget or Joint Commercialization Plan and Budget,
provided Epizyme first obtains BII’s prior written consent (not to be
unreasonably withheld or delayed), unless such subcontracting and Contractor are
specifically contemplated under the Joint Development Plan and Budget or Joint
Commercialization Plan and Budget. Epizyme will remain responsible and liable
for the actions of its Contractors, including with respect to breaches of this
Agreement.

6.6.Retention of Rights. Except as expressly provided herein, Epizyme grants no
additional rights or licenses to BII or its Affiliates in, to or under any
intellectual property rights Controlled by Epizyme. Except as expressly provided
herein, BII grants no additional rights or licenses to Epizyme or its Affiliates
in, to or under any intellectual property rights Controlled by BII.

6.7.Recordation. Following the Effective Date or at any time during the Term,
either Party at the request and expense of the other Party, shall promptly
register or record the licenses (including by registering a short-form license)
granted to such other Party under this Agreement with the appropriate patent
offices in all applicable countries of the Territory;

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provided that such registration or recordation specifies the applicable
limitations of such license; and provided further that such registration shall
have no effect on the allocation of Prosecution and Maintenance rights and
obligations set forth in ARTICLE 8 (Intellectual Property). In the event any of
the licenses granted by a Party to the other Party under this Agreement are
terminated, such other Party shall promptly take such actions and execute such
documents as are reasonably requested by the granting Party, to cancel such
registration(s) or recordation(s) in the applicable countries with respect to
the terminated license grants, at the expense of the Party that had requested
such registration(s) or recordation(s).

ARTICLE 7
Payments and Records

7.1.Upfront Payment. No later than [**] following the Effective Date (provided
BII has received both an originally signed version of this Agreement and an
Invoice from Epizyme), BII will pay Epizyme an upfront amount equal to Fifteen
Million Dollars ($15,000,000). Such payment will be non-creditable against any
other payments due hereunder.

7.2.Research Funding.

7.2.1Calendar Year 2019. As partial consideration (“Research Funding”) for the
costs to be incurred by Epizyme in connection with its Research Activities
pursuant to the Research Plan or any Remedial Plan for Calendar Year 2019 (with
the Parties acknowledgment that a portion of the amounts payable for achieving
preclinical research Milestone Events include partial consideration for the
costs to be incurred by Epizyme in connection with its Research Activities
pursuant to the Research Plan), BII will pay Epizyme Five Million Dollars
($5,000,000), divided into [**] payments of [**] Dollars ($[**]), and payable by
BII in [**] installments due within [**] for Calendar Year 2019, as long as BII
has received an Invoice from Epizyme with respect to the payment of such
amounts.

7.2.2Calendar Year 2020. In the event BII elects to extend the Research Period
pursuant to Section 3.2.2 (Extension), any additional Research Funding from BII
to Epizyme as consideration for the costs to be incurred by Epizyme in
connection with: (i) performing Research Activities not completed by Epizyme
under the prior Research Plan that BII desires for Epizyme to continue during
Calendar Year 2020; and (ii) any additional Research Activities not already
covered under the existing Research Plan (if any) undertaken pursuant to any
revisions made to the Research Plan for Calendar Year 2020, with respect to
(i)-(ii), and the timing of such payments, shall be agreed to by the Parties
pursuant to Section 3.2.2 (Extension; provided that, with respect to (i)-(ii),
BII shall be allowed to credit against any such additional Research Funding an
amount equal to the total budget of [**] Dollars ($[**]) that Epizyme has
allocated for its performance of Research Activities under the Research Plan in
Calendar Year 2019, minus the expenses Epizyme actually incurred in connection
with the performance of such activities, and BII shall make such payments in
accordance with such payment schedule.

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7.3.Milestone Payments. On a Target Project-by-Target Project basis, BII will
pay Epizyme the following amounts (each, a “Milestone Payment”) within [**]
after (a) the applicable event is first achieved with respect to a Target
Project, whether achieved by or on behalf of BII, its Affiliates or Sublicensees
and (b) BII’s receipt of an Invoice for such Milestone Payment (each, a
“Milestone Event”). BII will provide Epizyme written notice of the achievement
of a Milestone Event within [**] after its occurrence:

 

Milestone Event

Milestone Payment

(in [**] USD)

BII Controlled Project

(i.e., Achieved by BII Compound or BII Product)

Jointly Controlled Project

(i.e., Achieved by Joint Compound or Joint Product)

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

Each Milestone Payment made under this Section 7.3 (Milestone Payments) will be
payable only once, upon the first achievement of the applicable Milestone Event
by a Compound or Product, as applicable, with respect to a Target Project and no
additional amounts will be due for subsequent or repeated achievements of such
Milestone Event by a Compound or Product, as applicable, for such Target
Project. If Development or Commercialization of a Compound or Product is
discontinued after any Milestone Payment set forth in the above table has been
made with respect to such Compound or Product, and a different Compound or
Product from the same Target Project is selected to replace the discontinued
Compound or Product (each, a “Replacement Product”), then there shall be no
payment due upon achievement of the same Milestone Event by such Replacement
Product for which Epizyme already received a Milestone Payment for the original
Product. If a Compound or Product for a Target Project achieves a

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subsequent Milestone Event before achieving a prior Milestone Event
(“subsequent” being read to mean a Milestone Event (other than any of the
described [**] Milestone Events) that appears lower in the above table when
compared to another Milestone Event), then the Milestone Payments for both the
subsequent Milestone Event and for any previously unpaid and unachieved
Milestone Events for such Compound or Product shall be due and payable to
Epizyme upon achievement of the subsequent Milestone Event. For example, (i) if
a Product were to achieve the Milestone Event associated with [**] and
subsequently achieve [**] without achieving [**], then, upon [**], both the
Milestone Payment associated with [**] and the Milestone Payment associated with
[**] would become due and payable to Epizyme with respect to such Product, (ii)
if a Product were to achieve the Milestone Event associated with [**] prior to
achieving [**], then, upon [**], both the Milestone Payment associated with [**]
and the Milestone Payment associated with [**] would become due and payable to
Epizyme with respect to such Product and (iii) for clarity, if a Product were to
achieve a Milestone Event associated with [**] Milestone Events not yet achieved
with respect to such Product shall not become due and payable to Epizyme until
such [**] Milestone Event is achieved by such Product.

7.4.Royalties.

7.4.1Royalty Rates. Commencing upon the First Commercial Sale of a Product in a
country in the Territory, on a Product-by-Product basis, BII will pay to Epizyme
tiered royalties on Net Sales of each Product in the Territory or ROW as
applicable during each Calendar Year at the following rates:

Calendar Year Net Sales of a Product in a
Country in the Territory or ROW as Applicable

Royalty Rate

BII Controlled Project (i.e., Achieved by BII Product)

For that portion of aggregate Net Sales of a Product in the Territory during a
Calendar Year that are less than $[**]

[**]%

For that portion of aggregate Net Sales of a Product in the Territory during a
Calendar Year that are more than or equal to $[**] and less than or equal to
$[**]

[**]%

For that portion of aggregate Net Sales of a Product in the Territory during a
Calendar Year that are greater than $[**] and less than or equal to $[**]

[**]%

For that portion of aggregate Net Sales of a Product in the Territory during a
Calendar Year that are greater than $[**]

[**]%

Jointly Controlled Project (i.e., Achieved by Joint Product)

For that portion of aggregate Net Sales of a Product in the ROW during a
Calendar Year that are less than $[**]

[**]%

For that portion of aggregate Net Sales of a Product in the ROW during a
Calendar Year that are more than or equal to $[**] and less than or equal to
$[**]

[**]%

For that portion of aggregate Net Sales of a Product in the ROW during a
Calendar Year that are greater than $[**] and less than or equal to $[**]

[**]%

For that portion of aggregate Net Sales of a Product the ROW during a Calendar
Year that are greater than $[**]

[**]%

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7.4.2Royalty Term. With respect to each Product in each country in the
Territory, from and after the expiration of the Royalty Term for such Product in
such country, Net Sales of such Product in such country will be excluded for
purposes of calculating the Net Sales thresholds and ceilings set forth in
Section 7.4.1 (Royalty Rates), and BII will have no obligation to pay any
royalty on Net Sales of any Product in any country in the Territory after the
Royalty Term for such Product in such country has expired. Upon expiration of
the Royalty Term for a Product in a country, the license granted to BII pursuant
to Section 6.2 (Grant to BII) will be fully paid-up, royalty-free, perpetual and
irrevocable with respect to such Product in such country.

7.4.3Reductions. Notwithstanding the foregoing:

(a)in the event that, and in such case from and after the date on which, a
Product is sold in a country and is not covered by a Valid Claim of a Patent in
such country claiming the composition of matter of the underlying Compound for
such Product, the royalty rate set forth in Section 7.4.1 (Royalty Rates) with
respect to such country will be reduced by [**] percent ([**]%);

(b)in the event that BII enters into an agreement with a Third Party in order to
obtain a license under a Patent or other intellectual property right controlled
by such Third Party that is necessary to make, have made, use, offer to sell,
sell, import or export a BII Product in any country in the Territory or a Joint
Product in any country in ROW, BII will be entitled to deduct [**] percent
([**]%) of all Third Party Payments paid to such Third Party in respect of such
agreement from any payments due to Epizyme hereunder with respect to such
Product;

(c)in the event that in any country in the Territory during the Royalty Term for
a Product there is Generic Competition in such country, then, for each such
country, the royalties payable to Epizyme for the Net Sales of such Product in
such country will be reduced by [**] percent ([**]%) of the applicable royalty
rate(s) set forth in Section 7.4.1 (Royalty Rates); and

(d)notwithstanding the foregoing clauses (a)-(c), in no event will the royalties
due to Epizyme for any given Calendar Year in any country in the Territory for
any Product during the applicable Royalty Term be reduced by more than [**]
percent ([**]%), in the aggregate, of the amount otherwise due and payable to
Epizyme in such Calendar Year in such country for such Product pursuant to the
reductions set forth in this Section 7.4.3 (Reductions). BII shall have the
right to carry forward and offset against future royalties payable to Epizyme
with respect to the applicable Product, any amounts that, but for this Section
7.4.3(d), BII would have been entitled to deduct from any royalty payments to
Epizyme.

7.5.Royalty Payments and Reports. Royalties will be payable within [**] after
the end of the Calendar Quarter during which the applicable Net Sales of Product
occurred. In connection with the payment of royalties to Epizyme, BII shall also
provide Epizyme with a written report with respect to the Net Sales of Product
sold by or on behalf of BII, its Affiliates and Sublicensees during such
Calendar Quarter in each country of the Territory or ROW, as applicable, in
sufficient detail to permit confirmation of the accuracy of the royalty payments

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made to Epizyme. Each payment of royalties due to Epizyme will be accompanied by
(a) a statement of the amount of Net Sales of each Product during such Calendar
Quarter, (b) an itemized calculation of Net Sales for the Territory as a whole
and on a country-by-country basis, showing for both the deductions provided for
in the definition of “Net Sales” and (c) a calculation of the royalty payment
due on such Net Sales for such Calendar Quarter.

7.6.Mode of Payment; Offsets. All payments to either Party under this Agreement
will be made by deposit of Dollars in the requisite amount to such bank account
as the receiving Party may from time to time designate by notice to the paying
Party. In converting any amount expressed in a foreign currency into Dollars,
BII shall use the monthly average exchange rates used by BII throughout its
regular accounting system for the Calendar Quarter in which Product is sold.

7.7.Taxes; Withholding Taxes. All payments under or in connection with this
Agreement shall be inclusive of any Taxes and each Party shall be responsible
for and shall bear, pay or set-off its own Taxes assessed by a tax or other
authority except as otherwise set forth in this Agreement (as used in this
sentence, “Taxes” shall mean all forms of preliminary or finally imposed
taxation, domestic and foreign taxes, fees, levies, duties and other assessments
or charges of whatever kind (including but not limited to sales, use, excise,
stamp, transfer, property, value added, goods and services, withholding and
franchise taxes) together with any interest, penalties or additions payable in
connection with such taxes, fees, levies duties and other assessments or
charges). For purposes of value added tax (“VAT”), or similar indirect taxes
(e.g. goods and service tax), VAT/indirect taxes shall be added to the payments
due to the terms if legally applicable. The VAT amounts of invoices received by
one Party are not billable to the other Party as far as the first Party has an
input VAT deduction, i.e. is able to receive a refund by the competent
authority. If VAT is not refundable because of legal restrictions, which are not
caused by the first Party, the VAT amounts are billable to the other Party.
Prior to the invoicing of the aforementioned billable amounts written approval
by the other Party is mandatory. Legal restrictions which are caused by the
first Party and lead to a non-billable amount shall be the following but not
limited to (a) missing of a limitation period or (b) inaccurate documents in
order to receive the input VAT deduction. If Applicable Laws require withholding
by BII or its Affiliates of any taxes imposed upon Epizyme on account of any
royalties and other payments paid under this Agreement to the benefit of
Epizyme, such taxes have to be retained by BII or its Affiliates as required by
local law from such remittable royalty and other payment and shall be paid by
BII or its Affiliates to the proper tax authorities on account of Epizyme.
Official receipts of payment of any retained local withholding tax shall be
secured and sent by BII or its Affiliates to Epizyme as evidence of such payment
only on Epizyme’s request. The Parties shall cooperate and exercise their best
efforts to ensure that any withholding taxes imposed on Epizyme are reduced as
far as possible under the provisions of any relevant double tax treaty.
Withholding taxes retained by BII or its Affiliates and paid to the proper
German/local tax authorities as well as a possible refund of retained and paid
local withholding taxes from the German/local tax authorities in favor of
Epizyme are paid in local/German currency (Local currency/EUR). Any effect by
currency conversion is to the benefit or burden of Epizyme as tax-payer and are
not refundable or taken by BII and/or its Affiliates.

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7.8.Interest on Late Payments. Any undisputed amounts owed by a Party under this
Agreement that is not paid on or before the date such payment is due shall bear
interest, to the extent permitted by Applicable Law, at an annual rate of [**]
percent ([**]%) above the one (1) month EUR LIBOR rate that applied on the first
date on which payment was delinquent and calculated for the exact number of days
in the interest period based on a year of three hundred sixty (360) days
(actual/360). If the LIBOR is no longer published, the Parties will agree upon
another internationally recognized rate which has historically been
substantially equivalent to the one (1) month EUR LIBOR rate and utilize such
rate retroactively to such time as the rate was no longer available. Interest
shall not accrue on undisputed amounts that were paid after the due date as a
result of mistaken actions by the receiving Party (e.g., if a payment is late as
a result of the receiving Party providing an incorrect account for receipt of
payment).

7.9.Financial and Other Records. Each Party shall, and shall cause its
Affiliates to, keep complete and accurate books and records pertaining to Net
Sales of Products and Net Profits and Net Losses with respect to Joint Products
in sufficient detail to calculate all amounts payable hereunder and to verify
compliance with its obligations under this Agreement. Such books and records
shall be retained by such Party and its Affiliates until [**] after the end of
the period to which such books and records pertain or for such longer period as
may be required by Applicable Law.

7.10.Audit; Audit Dispute. At the request of the other Party, each Party will,
and will cause its Affiliates to, permit an independent public accounting firm
of nationally recognized standing designated by the other Party and reasonably
acceptable to the audited Party, at reasonable times during normal business
hours and upon reasonable notice, to audit the books and records maintained
pursuant to Section 7.9 (Financial and Other Records) solely to confirm the
accuracy of all Net Sales, royalty payments, Milestone Payments and financial
reports and payments made hereunder. Such examinations may not (a) be conducted
for any Calendar Quarter more than [**] after the end of such Calendar Quarter,
(b) be conducted more than [**] period (unless a previous audit during such [**]
period revealed an underpayment of at least [**] percent ([**]%) of the amount
actually due with respect to such period) or (c) be repeated for any Calendar
Quarter. The accounting firm will execute a reasonable written confidentiality
agreement with the audited Party and will disclose to the auditing Party only
such Information as is reasonably necessary to provide the auditing Party with
information regarding any actual or potential discrepancies between amounts
reported and actually paid and amounts payable under this Agreement. The
accounting firm’s report will include the methodology and calculations used to
determine the results, will be delivered to each Party at the same time and,
unless such report is disputed by a Party as set forth below, will be deemed
final [**] after it is received by both Parties. Each Party will have the right
during such [**] period to discuss the report with the accounting firm. In the
event a Party disputes any portion of the accounting firm’s report following
such [**] period, then, no later than [**] following the end of such [**]
period, such Party may refer such dispute for resolution in accordance with
Section 14.7 (Dispute Resolution). The auditing Party shall bear the full cost
of any such audit, unless the accounting firm’s report discloses an underpayment
by the audited Party of more than [**] percent ([**]%) of the amount due for any
Calendar Quarter, in which case the audited Party shall bear the full cost of
such audit. The audited Party shall pay the amount of any undisputed
underpayment disclosed in the accounting firm’s report, together with interest
thereon from the date such payment was originally due, within [**] after
delivery to the Parties of the accounting firm’s

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report. If the accounting firm’s report discloses an undisputed overpayment by
the audited Party, the auditing Party will reimburse the audited Party for such
excess amount within [**] after delivery to the Parties of the accounting firm’s
report (or credit such overpayment against any royalties subsequently owed to
Epizyme in the event the audited Party is BII, unless, for clarity, there are
insufficient subsequent royalties due to Epizyme, in which case, upon the
expiration of BII’s obligations to pay royalties hereunder, Epizyme will
reimburse BII for the amount of such overpayment not previously credited). Upon
the expiration of [**] following the end of any Calendar Quarter, the
calculation of royalty payments with respect to such Calendar Quarter shall be
binding on the Parties and each Party shall be released from any liability and
obligation with respect to payments for such year, except in the case of fraud
or willful deceit.

7.11.Confidentiality. The receiving Party will treat all Information subject to
review under this ARTICLE 7 (Payments and Records) in accordance with the
confidentiality provisions of ARTICLE 10 (Confidentiality and Non-Disclosure).

ARTICLE 8
Intellectual Property

8.1.Ownership of Intellectual Property.

8.1.1Ownership of Technology. Subject to Section 8.1.2 (Ownership of Joint
Technology), as between the Parties, each Party shall own and retain all right,
title and interest in and to any and all: (a) Information and inventions that
are conceived, discovered, developed or otherwise made by or on behalf of such
Party (or its Affiliates or Sublicensees) under or in connection with this
Agreement, whether or not patented or patentable, and any and all Patents and
other intellectual property rights with respect thereto, except to the extent
that any such Information or invention or any Patent or intellectual property
rights with respect thereto, is Joint Know-How or Joint Patents; provided that
any Information or inventions conceived, discovered, developed or otherwise made
by or on behalf of such Party (or its Affiliates or Sublicensees) while
exercising its rights under Section 8.2.2 (Epizyme Patents) or Section 8.2.3
(BII Patents) to review and comment on any material communications to and from
any Patent authority or drafts of any material filings or responses to be made
to Patent authorities in connection with the preparation, filing, prosecution or
maintenance of a specific Patent shall inure to the benefit of and be owned by
the Party who owns such Patent and (b) other Information, inventions, Patents
and other intellectual property rights that are owned or otherwise Controlled
(other than pursuant to the licenses granted under Sections 6.1 (Grant to
Epizyme) and 6.2 (Grant to BII)) by such Party, its Affiliates or its
Sublicensees.

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8.1.2Ownership of Joint Technology. As between the Parties, the Parties shall
each own an equal, undivided interest in any and all (a) Information and
inventions that are conceived, discovered, developed or otherwise made jointly
by or on behalf of Epizyme or its Affiliates or Sublicensees, on the one hand,
and BII or its Affiliates and Sublicensees, on the other hand, in connection
with the work conducted under or in connection with this Agreement, in each
case, whether or not patented or patentable (the “Joint Know-How”) and
(b) Patents (the “Joint Patents”) and other intellectual property rights with
respect to the Information and inventions described in clause (a) (together with
Joint Know-How and Joint Patents, the “Joint Technology”). Each Party shall
promptly disclose to the other Party in writing, and shall cause its Affiliates
and Sublicensees to so disclose, the development, making, conception or
reduction to practice of any Joint Technology. Subject to the licenses granted
under Section 6.1 (Grant to Epizyme) and Section 6.2 (Grant to BII), the
exclusivity obligations under Section 4.4 (Exclusivity) and any other
conditions, requirements or limitations under this Agreement, each Party shall
have the right to Exploit the Joint Technology without a duty of seeking consent
or accounting to the other Party.

8.1.3United States Law. The determination of whether Information and inventions
are conceived, discovered, developed, or otherwise made by a Party for the
purpose of allocating proprietary rights (including Patent, copyright or other
intellectual property rights) therein, shall, for purposes of this Agreement, be
made in accordance with Applicable Law in the United States irrespective of
where such conception, discovery, development or making occurs.

8.1.4Assignment Obligation. Each Party shall cause all Persons who perform
Research Activities or who conduct Development, Manufacturing and
Commercialization activities for such Party under this Agreement with respect to
Compounds or Products to be under an obligation to assign their rights in any
Information and inventions resulting therefrom to such Party, except where
Applicable Law requires otherwise.

8.1.5Ownership of Product Marks. BII shall own all Trademarks, together with all
goodwill related thereto, used on or in connection with Products in the
Territory (collectively, “Product Marks”), and shall, at its sole cost and
acting in its sole discretion, be responsible for the procurement, maintenance,
enforcement and defense of all Product Marks in the Territory. BII shall have
the right to obtain from the World Health Organization International
Nonproprietary Name Committee and the US Adopted Names Council a generic name
for the Products.

8.1.6German Statute. With respect to “Employee Inventions” as defined by and
subject to the German Employee Inventions Act (Gesetz über
Arbeitnehmererfindungen “ArbnErfG”) that are conceived, discovered, developed,
or otherwise made by employees of a Party (or its Affiliates) under or in
connection with this Agreement, such Party shall claim rights in and to such
Employee Inventions in accordance with Section 6 et seq. of the ArbnErfG, unless
and to the extent the JSC has resolved that it would not be commercially
reasonable to do so. The Party subject to the ArbnErfG shall be solely
responsible for any payments to its employees and such Party will take all
actions necessary to obtain the rights to use any such inventions for the other
Party. This section shall also apply to “Technical Improvements” as defined in
Section 3 of the ArbnErfG.

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8.2.Maintenance and Prosecution of Patents.

8.2.1Patent Liaisons. Promptly (but in no event more than [**]) following the
Effective Date, the Parties shall each designate a representative to consult
with the other Party’s representative with respect to preparing, filing,
prosecuting, maintaining, enforcing and defending the Epizyme Patents, BII
Patents and Joint Patents (such representatives, the “Patent Liaisons”). The
Patent Liaisons shall discuss and provide input to each other, at such times,
places and frequencies as mutually agreed, all material issues with respect to
preparing, filing, prosecuting, maintaining, enforcing and defending the Epizyme
Patents, BII Patents and Joint Patents; provided that all final decisions
related to preparing, filing, prosecuting, maintaining, enforcing and defending
any Epizyme Patents, BII Patents or Joint Patents shall be made by the Party
with the right to control such preparation, file, prosecution, maintenance,
enforcement or defense, as applicable, as set forth in this ARTICLE 8
(Intellectual Property).

8.2.2Epizyme Patents. Epizyme shall be responsible for the Prosecution and
Maintenance of the Epizyme Patents (other than Epizyme Product Patents, which
are subject to Section 8.2.4 (Joint Patents and Epizyme Product Patents)) and
Epizyme Carve-Out Patents, which are subject to Section 8.2.5 (Epizyme Carve-Out
Patents), at its sole expense. Epizyme will reasonably inform BII (or its
designee) regarding the filing, prosecution, defense and maintenance of the
Epizyme Patents (including in any case, an update at least [**]), and Epizyme
shall give BII (or its designee) an opportunity to review the text of each
application, office action response or other substantive document for such
Epizyme Patent before filing with any patent office in the Territory, and shall
reasonably consider BII’s (or its designee’s) reasonable comments with respect
thereto, and shall supply BII (or its designee) with a copy of each such
application, office action response or other substantive document as filed,
together with notice of its filing date and serial number. Epizyme shall notify
BII (or its designee) at least [**] in advance of the next deadline if (i)
Epizyme decides that it does not wish to continue paying for the Prosecution and
Maintenance of an Epizyme Patent in any country and for which no substitute has
been filed or (ii) Epizyme decides to irrevocably abandon a claim scope in an
Epizyme Patent and BII determines that such claim scope proposed to be abandoned
can be separately filed in a divisional or other filing separate from such
Epizyme Patent without having a detrimental effect on the patentability of such
claim scope, Epizyme shall allow BII (or its designee) to assume sole
responsibility and control for Prosecution and Maintenance of such Epizyme
Patent or divisional or other filing, as applicable, including payments
incurred, after [**] after receipt of Epizyme’s notice. If BII determines that
the proposed abandoned claim scope cannot be separately filed without having a
detrimental effect on the patentability of such claim scope, then Epizyme shall
maintain and continue to prosecute such claim scope in the Epizyme Patent and
the Parties will thereafter equally share all fees and costs related to
Prosecution and Maintenance of such Epizyme Patent. If BII (or its designee)
assumes such responsibility and control, then BII (or its designee) may
designate any counsel of its choice to handle the Prosecution and Maintenance of
such Epizyme Patent or of such divisional or other filings, as applicable, and
(A) it shall no longer be considered an Epizyme Patent, (B) such Patent or such
divisional or other filing, as applicable, shall cease to be considered an
Epizyme Patent and (C) Epizyme hereby assigns and transfers all its right, title
and interest in such Patent or such divisional or other filing, as applicable,
to BII as the sole owner and shall execute any documents necessary to reflect
such ownership. For clarity, BII’s step-in rights to Prosecute and Maintain an
Epizyme Patent or such divisional or other filing under this Section 8.2.2 shall
only apply to the Epizyme Patents that are not also Epizyme Product Patents
(which step-in rights are governed by Section 8.2.4(e)).

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8.2.3BII Patents. For clarity, BII shall always be responsible for the
Prosecution and Maintenance of any BII Patents, at its sole expense and in its
sole discretion; provided that, with respect to any BII Patents that Cover a
Compound or Product or method of use of a Compound or Product (the “BII Product
Patents”), BII shall give Epizyme (or its designee) an opportunity to review the
text of each application, office action response or other substantive document
for such BII Product Patent before filing with any patent office in the
Territory, and shall reasonably consider Epizyme’s (or its designee’s)
reasonable comments with respect thereto, and shall supply Epizyme (or its
designee) with a copy of each such application, office action response or other
substantive document as filed, together with notice of its filing date and
serial number. BII shall notify Epizyme (or its designee) at least [**] in
advance of the next deadline if (i) BII decides that it does not wish to
continue paying for the Prosecution and Maintenance of such BII Product Patent
in any country and for which no substitute has been filed or (ii) BII decides to
irrevocably abandon a claim scope in a BII Product Patent and Epizyme determines
that such claim scope proposed to be abandoned can be separately filed in a
divisional or other filing separate from such BII Product Patent without having
a detrimental effect on the patentability of such claim scope, BII shall allow
Epizyme (or its designee) to assume sole responsibility and control for
Prosecution and Maintenance of such BII Product Patent or divisional or other
filing, as applicable, including payments incurred, after [**] after receipt of
BII’s notice. If Epizyme determines that the proposed abandoned claim scope
cannot be separately filed without having a detrimental effect on the
patentability of such claim scope, then BII shall maintain and continue to
prosecute such claim scope in the BII Patent and the Parties will thereafter
equally share all fees and costs related to Prosecution and Maintenance of such
BII Patent. If Epizyme (or its designee) assumes such responsibility and
control, then Epizyme (or its designee) may designate any counsel of its choice
to handle the Prosecution and Maintenance of such BII Product Patent or of such
divisional or other filings, as applicable, and (A) it shall no longer be
considered a BII Product Patent, (B) such Patent or such divisional or other
filing, as applicable, shall cease to be considered a BII Product Patent and (C)
BII hereby assigns and transfers all its right, title and interest in such
Patent or such divisional or other filing, as applicable, to Epizyme as the sole
owner and shall execute any documents necessary to reflect such ownership.

8.2.4Joint Patents and Epizyme Product Patents. The Prosecution and Maintenance
of the Epizyme Product Patents and Joint Patents (collectively, the “Joint
Counsel Patent Rights”) shall be through mutually selected patent counsel.
Within a reasonable period of time following the Effective Date, the Parties
shall mutually agree on a patent counsel (“Joint Counsel”) who shall be engaged
by both Parties for the Prosecution and Maintenance of all Joint Counsel Patent
Rights. Subject to Section 8.5.2 (Invalidity or Unenforceability Defenses or
Actions – Epizyme Product Patents and Joint Patents), the following terms shall
apply to each Joint Counsel Patent Right:

(a)The Joint Counsel shall give BII and Epizyme (or each Party’s designee) an
opportunity to review the text of each application, office action response or
other substantive document for a Joint Counsel Patent Right before filing with
any patent office in the Territory, shall incorporate BII’s and Epizyme’s (or
each Party’s designee) reasonable comments with respect thereto and shall supply
BII and Epizyme (or each Party’s designee) with a copy of each such application,
office action response or other substantive document as filed, together with
notice of its filing date and serial number; provided that Epizyme, through
counsel

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of its choosing, will have the right to draft each initial application for an
Epizyme Product Patent or Joint Patent and will provide BII with such draft
application for review, comment and proposed edits, and the Parties will discuss
and agree on the final text of such application and, in the event of a
disagreement among the Parties, the Joint Counsel will decide on the final text
of the application with a clear prioritization, in all instances, to protecting
the worldwide patentability of the Compounds covered by such application, even
if such prioritization results in any detrimental effects to compounds (which
are not Compounds) that may be covered under such application. Once the final
text of any patent application under this Section 8.2.4(a) is available, such
patent application will then be Prosecuted and Maintained in accordance with
this Section 8.2.4 (Joint Patents and Epizyme Product Patents). In addition to
the foregoing, BII and Epizyme (or each Party’s designee) may also provide the
Joint Counsel with proactive suggestions with respect to the Prosecution and
Maintenance of the Joint Counsel Patent Rights at times when no filing is
otherwise requested or contemplated, and the Joint Counsel shall reasonably
consider any such suggestions. In the event that Epizyme and BII provide Joint
Counsel with conflicting instructions regarding the Prosecution and Maintenance
of a Joint Counsel Patent Right, Joint Counsel shall make the Parties aware of
such conflicting instructions and, if the Parties are not able to resolve such
conflict within a reasonable time prior to the applicable filing deadline, then
the Joint Counsel shall take such action as would reasonably be expected to
maximize the scope, extent and coverage of such Joint Counsel Patent Right with
a clear prioritization, in all instances, to protecting the worldwide
patentability of Compounds covered by such Joint Counsel Patent Right, even if
such prioritization results in any detrimental effects to compounds (which are
not Compounds) that may be covered under such Joint Counsel Patent Right.
Notwithstanding the foregoing, BII shall have final decision-making authority
with respect to the subject matter to be filed on (subject to Section 8.2.5(b)),
the timing of filing and country scope for any Joint Counsel Patent Right;
provided that BII shall not, and shall direct the Joint Counsel to not, without
first obtaining Epizyme’s prior written consent, allow the Epizyme Product
Patent directed to [**] to lapse or expire without having filed at least a PCT
application by the [**] of the filing date of the application for such Epizyme
Product Patent. Notwithstanding the foregoing, in the event that: (i) no
Compound included in the PCT application has received [**] and (ii) BII, in good
faith, determines that publication of such PCT application may have a
detrimental effect on the patentability of any Compound that may receive [**],
then BII may direct the Joint Counsel to withdraw the aforementioned Epizyme
Product Patent prior to its publication in order to prevent its publication.
Joint Counsel shall be given the directive that, in the Prosecution and
Maintenance of the Joint Counsel Patent Rights, Joint Counsel shall take all
actions with a clear prioritization, in all instances, to protecting the
worldwide patentability of the Compounds and Products covered by such Joint
Counsel Patent Right, even if such prioritization results in any detrimental
effects to compounds (which are not Compounds) that may be covered under such
Joint Counsel Patent Right. Once any Joint Counsel Patent Right is granted,
issued or indicated as allowable by any patent authority, under no circumstances
shall any reissue, reexamination or other reopening of the prosecution be
allowed for the purposes of protecting (1) a product that is not a Product, (2)
a compound that is not a Compound or (3) the manufacture or use of any of the
foregoing (1)-(2), absent BII’s prior written consent, which may be withheld in
BII’s sole discretion.

(b)Both Parties shall reasonably cooperate with Joint Counsel in Prosecution and
Maintenance of patent applications for Joint Counsel Patent Rights, including
providing Joint Counsel with data and other Information as appropriate with
respect thereto.

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(c)Joint Counsel shall keep BII and Epizyme advised of the status of the
Prosecution and Maintenance of Joint Counsel Patent Rights, including actual and
prospective patent filings for Joint Counsel Patent Rights, and shall provide
each Party with advance copies of any and all papers related thereto. Joint
Counsel shall promptly give notice to BII and Epizyme of the grant, lapse,
revocation, surrender, invalidation or abandonment of any Joint Counsel Patent
Right.

(d)BII shall bear all fees and costs charged by Joint Counsel with respect to
the Prosecution and Maintenance of Joint Counsel Patent Rights and all other
mutually agreed and approved out-of-pocket costs and expenses incurred by either
Party in connection with such Prosecution and Maintenance of Joint Counsel
Patent Rights.

(e)BII shall notify Epizyme and Joint Counsel at least [**] in advance of the
next deadline if (i) BII decides that it does not wish to continue paying for
the Prosecution and Maintenance of any Joint Counsel Patent Right and for which
no substitute has been filed or (ii) BII decides that it intends to irrevocably
abandon claim scope in any Joint Counsel Patent Right, in which case, with
respect to this clause (ii), Epizyme may assume responsibility for such claim
scope. In such cases (i) or (ii), BII shall allow Epizyme to assume
responsibility and control for Prosecution and Maintenance of the respective
Patent, including payments incurred after [**] after receipt of BII’s notice. If
Epizyme assumes such responsibility and control, then: (1) Epizyme may designate
any counsel of its choice to handle the Prosecution and Maintenance of such
Joint Counsel Patent Right or of such claim scope, as applicable, and such
Patent shall no longer be considered a Joint Counsel Patent Right but, rather,
shall be considered an Epizyme Patent and (2) in case of a Joint Patent or claim
scope therein, BII shall and hereby does assign and transfer all right, title
and interest in such Joint Patent or such claim scope therein, as applicable, to
Epizyme as the sole owner. If Epizyme decides not to assume such responsibility,
then it shall instruct Joint Counsel to abandon the Prosecution and Maintenance
of such Joint Counsel Patent Right or claim scope, as applicable.

(f)At least every [**] during the Term, the Parties through their respective
Patent Liaison’s will work together to generate appropriate lists clearly
designating Epizyme Patents (and of those which are Epizyme Product Patents),
BII Patents and any Joint Patents.

8.2.5Epizyme Carve-Out Patents.

(a)With respect to any Epizyme Product Patent that is not yet the subject of a
PCT application or U.S. non-provisional application and that has a specification
that Epizyme believes, in good faith, sets forth one or more claims that Cover
(i) a product that is not a Product, (ii) a compound that is not a Compound or
(iii) the manufacture or use of any of the foregoing (i)-(ii) and, wherein
(i)-(iii) are based upon a compound which has a core structure that is different
and considered by the Parties to be patentably distinct from any Compound set
forth in such Epizyme Product Patent, Epizyme may request, in writing to BII,
that BII consider the feasibility of filing one or more separate patent
applications for such claims. In the event that Epizyme makes such a request,
the Parties shall work together to determine the feasibility of filing such
separate patent applications. If the Parties: (1) agree on the feasibility of
filing such separate patent applications, they shall direct Joint Counsel to
prepare the text of such

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applications, subject to the Parties review and input as described further below
or (2) do not agree on the feasibility of filing such separate patent
applications, then the Joint Counsel shall promptly consider Epizyme’s request
and, if the Joint Counsel determines, acting in good faith, that making one or
more separate patent applications is feasible and will not have any detrimental
effect on the Patents Covering Compounds or Products, then the Joint Counsel
shall file, in Epizyme’s name, one or more separate patent applications
requested by Epizyme (such applications and issued Patents under either clause
(1) or (2), the “Epizyme Carve-Out Patents”). The Joint Counsel shall give
Epizyme (or its designee) and BII (or its designee) an opportunity to review the
text of each such application prior to filing, shall incorporate Epizyme’s and
BII’s (or each Party’s designee) comments with respect thereto and shall supply
BII and Epizyme (or each Party’s designee) with a copy of each such application,
together with notice of its filing date and serial number. Upon such filing,
Epizyme shall assume responsibility for Prosecuting and Maintaining such Epizyme
Carve-Out Patent pursuant to Section 8.2.5(c). With respect to any Epizyme
Product Patent that is already the subject of a filed PCT application or U.S.
non-provisional application, then an Epizyme Carve-Out Patent filing shall only
be authorized upon BII’s prior written consent and in BII’s sole discretion.

(b)In the event that the Joint Counsel determines that making one or more
separate patent applications as set forth in Section 8.2.5(a) is not feasible or
may have a detrimental effect on the Compounds or Products such that no Epizyme
Carve-Out Patent is filed, then, with respect to the claims of the Epizyme
Product Patent Covering such products, compounds or manufacturing or use rights,
the Joint Counsel shall nevertheless incorporate Epizyme’s (or its designee)
reasonable comments, statements or amendments with respect thereto in the text
of each application, office action response or other substantive document for
such Epizyme Product Patent, unless BII believes, acting in good faith, that
such comments, statements or amendments, if incorporated, may have a detrimental
effect on Patents Covering the Compounds or Products.

(c)With respect to the Epizyme Carve-Out Patents, once the Joint Counsel files a
patent application for an Epizyme Carve-Out Patent pursuant to Section 8.2.5(a),
Epizyme shall be responsible for the Prosecution and Maintenance of such Epizyme
Carve-Out Patent, at its sole expense and in its sole discretion. For clarity,
in no event will an Epizyme Carve-Out Patent be deemed to be an Epizyme Patent
or a Joint Counsel Patent Right. Notwithstanding the foregoing, Epizyme shall
not take any action or fail to take any action in connection with the
Prosecution and Maintenance of any Epizyme Carve-Out Patent that may have, or
actually results in, any detrimental effect upon the patentability, validity or
enforceability of any Patent Right Covering Compounds or Products and Epizyme
shall keep BII fully advised of any references, other evidence and any other
actions taken in connection with the Prosecution and Maintenance of Epizyme
Carve-Out Patents that may be relevant to the patentability, validity or
enforceability of any Patent Right Covering Compounds or Products. Without
limiting the foregoing, Epizyme shall not introduce any disclosure or claims in
any Epizyme Carve-Out Patent covering Compounds.

(d)Epizyme shall ensure that all obligations of Epizyme under this Agreement
with respect to the Epizyme Carve-Out Patents will be placed upon any Third
Party who secures rights with respect to the Prosecution and Maintenance of the
Epizyme Carve-Out Patents.

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8.2.6Patent Term Extensions. Notwithstanding anything to the contrary in this
ARTICLE 8 (Intellectual Property), the Parties shall discuss in good faith and
seek to reach mutual agreement for which, if any, of the Patents within the
Epizyme Product Patents, BII Product Patents and Joint Product Patents they
shall apply to obtain patent term extensions, adjustments, restorations or
supplementary protection certificates under Applicable Laws, based on the best
commercial interests of the Compounds or Products Covered by such Patents. If
the Parties are unable to reach mutual agreement on which Patent to apply to
obtain patent term extensions, adjustments, restorations or supplementary
protection certificates, then BII shall have the right to make the final
decision. If, with respect to a Product, the Patents for which the Parties (or
BII, in the event the Parties are unable to mutually agree) determine to apply
to obtain patent term extensions, adjustments, restorations or supplementary
protection certificates do not claim the composition of matter of the Compound
in such Product, then, notwithstanding the decision to extend a non-composition
of matter Patent, in determining the Royalty Term for such Product, the period
referred to in clause (a) of the definition of Royalty Term shall refer to
expiration of the last Epizyme Patent, BII Patent or Joint Patent that includes
a Valid Claim claiming the composition of matter of the Compound in such Product
as if such Epizyme Patent, BII Patent or Joint Patent had been extended.

8.2.7Patent Listings. BII, in consultation with the Patent Liaisons, shall have
the sole right to make all filings with Regulatory Authorities throughout the
Territory with respect to BII Patents, Joint Patents and Epizyme Product
Patents, including as required or allowed in the United States, in the FDA’s
Orange Book or other international equivalents. Epizyme shall (i) provide to BII
all Information necessary or reasonably useful to enable BII to make such
filings with Regulatory Authorities in the Territory with respect to such
Patents and (ii) cooperate with BII’s reasonable requests in connection
therewith, including meeting any submission deadlines, in each case ((i) and
(ii)), to the extent required or permitted by Applicable Law.

8.3.Enforcement of Patents.

8.3.1Enforcement of Epizyme Product Patents and Joint Patents. Each Party (or
its Patent Liaison) shall promptly notify the other Party in writing of any
alleged or threatened infringement of the Epizyme Product Patents or Joint
Patents, with respect to each, by a Third Party in the Territory of which it
becomes aware (including alleged or threatened infringement based on the
development, commercialization or an application to market a product containing
a Compound or any Product in the Territory (a “Joint Product Infringement”)).
BII, in consultation with the Patent Liaisons, shall have the first right, but
not the obligation, to prosecute any Joint Product Infringement in the Territory
(the “Joint Product Prosecuted Infringements”) at its sole expense and BII shall
retain control of the prosecution of such claim, suit or proceeding. In the
event BII prosecutes any Joint Product Prosecuted Infringement, Epizyme shall
join as a party if requested by BII, at BII’s cost, and will otherwise have the
right, but not the obligation to join as a party to such claim, suit or
proceeding in the Territory and participate with its own counsel at its own
expense; provided that BII shall retain control of the prosecution of such
claim, suit or proceeding. If Epizyme agrees, after good faith discussion with
BII, to bring other Epizyme Patents into such claim, suit or proceeding, the
Epizyme Patent Liaison shall work with the BII Patent Liaison to identify such
other Epizyme Patents and assist and cooperate with BII to assert such Epizyme
Patents in such claim, suit or proceeding;

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provided that BII shall retain control of the prosecution of such claim, suit or
proceeding. During any such claim, suit or proceeding, BII shall not settle any
such claim, suit or proceeding except in a manner that BII believes, in good
faith, is in the best interests of the Compounds or Products. If BII does not
take commercially reasonable steps to prosecute a Joint Product Prosecuted
Infringement (i) within [**] following the first notice provided above with
respect to the Joint Product Prosecuted Infringement or (ii) provided such date
occurs after the first such notice of the Joint Product Prosecuted Infringement
is provided, [**] before the time limit, if any, set forth in Applicable Law for
filing of such actions, whichever comes first, then Epizyme, in consultation
with the Patent Liaisons, may prosecute the Joint Product Prosecuted
Infringement at its own expense; provided, however, that Epizyme must consider,
in good faith, any reasons provided by BII for not prosecuting such Joint
Product Infringement. Epizyme shall not, and agrees not to, prosecute any
alleged, threatened or actual infringement of any Epizyme Product Patents or
Joint Patents that is not a Joint Product Infringement absent prior written
consent from BII, which may be withheld in BII’s sole discretion. In the event
BII provides such consent, Epizyme shall not prosecute such action or settle any
such claim, suit or proceeding except in a manner that Epizyme believes, in good
faith, is in the best interests of the Compounds or Products covered by such
Patent.

8.3.2Enforcement of Other Epizyme Patents. Each Party (or its Patent Liaison)
shall promptly notify the other Party in writing of any alleged or threatened
infringement of the Epizyme Patents (other than Epizyme Product Patents, which
are handled pursuant to Section 8.3.1 (Enforcement of Epizyme Product Patents
and Joint Patents)) or Epizyme Carve-Out Patents by a Third Party in the
Territory of which such Party becomes aware. Epizyme shall have the sole right,
but not the obligation, in consultation with the Patent Liaisons, to prosecute
any such infringement in the Territory at its sole expense and Epizyme shall
retain control of the prosecution of such claim, suit or proceeding; provided
that Epizyme will not be required to consult with the Patent Liaisons in
connection with prosecuting an infringement claim concerning the Epizyme
Carve-Out Patents.

8.3.3Enforcement of BII Product Patents. Each Party (or its Patent Liaison)
shall promptly notify the other Party in writing of any alleged or threatened
infringement of the BII Product Patents by a Third Party in the Territory of
which it becomes aware (including alleged or threatened infringement based on
the development, commercialization or an application to market a product
containing a Compound or any Product in the Territory (a “BII Product
Infringement”)). BII, in consultation with the Patent Liaisons, shall have the
first right, but not the obligation, to prosecute any BII Product Infringement
in the Territory (the “BII Product Prosecuted Infringements”) at its sole
expense and BII shall retain control of the prosecution of such claim, suit or
proceeding. In the event BII prosecutes any BII Product Prosecuted Infringement,
Epizyme shall join as a party if requested by BII, at BII’s cost, and will
otherwise have the right, but not the obligation to join as a party to such
claim, suit or proceeding in the Territory and participate with its own counsel
at its own expense; provided that BII shall retain control of the prosecution of
such claim, suit or proceeding. During any such claim, suit or proceeding, BII
shall not settle any such claim, suit or proceeding except in a manner that BII
believes, in good faith, is in the best interests of the Compounds or Products.
If BII does not take commercially reasonable steps to prosecute a BII Product
Prosecuted Infringement (i) within [**] following the first notice provided
above with respect to the BII Product Prosecuted Infringement or (ii) provided
such date occurs after the first such notice of

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the BII Product Prosecuted Infringement is provided, [**] before the time limit,
if any, set forth in Applicable Law for filing of such actions, whichever comes
first, then Epizyme, in consultation with the Patent Liaisons, may prosecute the
BII Product Prosecuted Infringement at its own expense; provided, however, that
Epizyme must consider, in good faith, any reasons provided by BII for not
prosecuting such BII Product Infringement. Epizyme shall not, and agrees not to,
prosecute any alleged, threatened or actual infringement of any BII Product
Patent that is not a BII Product Infringement absent prior written consent from
BII, which may be withheld in BII’s sole discretion. In the event BII provides
such consent, Epizyme shall not prosecute such action or settle any such claim,
suit or proceeding except in a manner that Epizyme believes, in good faith, is
in the best interests of the Compounds or Products covered by such Patent.

8.3.4Enforcement of Other BII Patents. Each Party (or its Patent Liaisons) shall
promptly notify the other Party in writing of any alleged or threatened
infringement of the BII Patents (other than the BII Product Patents, which is
handled pursuant to Section 8.3.3 (Enforcement of BII Product Patents)) by a
Third Party in the Territory of which such Party becomes aware. BII shall, in
consultation with the Patent Liaisons, have the sole right, but not the
obligation, to prosecute any such infringement in the Territory at its sole
expense and BII shall retain control of the prosecution of such claim, suit or
proceeding.

8.3.5Generic Competition. Notwithstanding the foregoing, if either Party or its
Patent Liaison (a) reasonably believes that a Third Party may be filing or
preparing or seeking to file a generic or abridged Drug Approval Application
that refers or relies on regulatory documentation submitted by either Party to
any Regulatory Authority, (b) receives any notice of certification regarding the
Epizyme Patents, BII Patents or the Joint Patents pursuant to the U.S. “Drug
Price Competition and Patent Term Restoration Act” of 1984 (21 United States
Code §355(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV)) (“ANDA Act”) claiming that any
such Patents are invalid or unenforceable or claiming that any such Patents will
not be infringed by the Manufacture, use, marketing or sale of a product for
which an application under the ANDA Act is filed or (c) receives any equivalent
or similar certification or notice in any other jurisdiction, it shall
(i) notify the other Party (or its Patent Liaison) in writing identifying the
alleged applicant or potential applicant and furnishing the information upon
which determination is based and (ii) provide the other Party (or its Patent
Liaison) with a copy of any such notice of certification within [**] of the date
of receipt and the Parties’ rights and obligations with respect to any legal
action as a result of such certification shall be as set forth in Sections
8.3.1, 8.3.2, 8.3.3 or 8.3.5, as applicable; provided that, if the Party
entitled to first enforce the Patents pursuant to the foregoing Sections elects
not to bring suit against the Third Party providing notice of such certification
within [**] of receipt of such notice, the other Party shall have the right, but
shall not be obligated, to bring suit against such Third Party. Notwithstanding
the foregoing, Epizyme shall not, and agrees not to, bring such suit against the
Third Party if it is not in connection with a Generic Product (as defined in
Section 1.84 (Definition of “Generic Product”) absent prior written consent from
BII, which may be withheld in BII’s sole discretion.

8.3.6Cooperation. The Parties and their Patent Liaisons agree to cooperate fully
in any infringement action pursuant to Section 8.3 (Enforcement of Patents).
Where a Party brings such an action, the other Party will, where necessary,
furnish a power of attorney solely for such purpose or will join in, or be named
as a necessary party to, such action.

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Unless otherwise set forth herein, the Party entitled to bring any Patent
infringement litigation in accordance with Section 8.3 (Enforcement of Patents)
will have the right to settle such claim; provided that neither Party will have
the right to settle any Patent infringement litigation under Section 8.3
(Enforcement of Patents) in a manner that diminishes or has a material adverse
effect on the rights or interest of the other Party, or in a manner that imposes
any costs or liability on, or involves any admission by, the other Party,
without the express written consent of such other Party. The Party commencing
the litigation will provide the other Party’s Patent Liaison with copies of all
pleadings and other documents filed with the court and will consider reasonable
input from the other Party’s Patent Liaison during the course of the
proceedings.

8.3.7Recovery. Any recovery realized as a result of such litigation described in
Section 8.3 (Enforcement of Patents) (whether by way of settlement or otherwise)
will be first, allocated to reimburse the Parties for their costs and expenses
in making such recovery (which amounts will be allocated pro rata if
insufficient to cover the totality of such expenses). Any remainder after such
reimbursement is made will be retained by the Party that has exercised its right
to bring the enforcement action; provided that (i) to the extent that any award
or settlement (whether by judgment or otherwise) is attributable to loss of
sales with respect to a BII Product, the Parties will treat such amount as Net
Sales for such BII Product, (ii) to the extent that any award or settlement
(whether by judgment or otherwise) is attributable to loss of sales with respect
to a Joint Product in the ROW, the Parties will treat such amount as Net Sales
for such Joint Product in the ROW and (iii) in the event of an infringement that
is competitive with a Joint Product in the United States, all recoveries will be
treated as Net Sales and allocated in accordance with Section 5.2.2(a)(iv)
(Allocation).

8.4.Infringement Claims by Third Parties. If the Development, Manufacture,
Commercialization or other Exploitation of a Compound, Product or Diagnostic
Product in the Territory pursuant to this Agreement results in, or may result
in, any claim, suit or proceeding by a Third Party alleging Patent infringement
by a Party (or its Affiliates or Sublicensees), the Party (or its Patent
Liaison) first having knowledge of such claim, suit or proceeding shall promptly
notify the other Party thereof in writing. BII, in consultation with the Patent
Liaisons, shall have the first right, but not the obligation, to defend and
control the defense of any such claim, suit or proceeding at its own expense,
using counsel of its own choice. Epizyme may participate in any such claim, suit
or proceeding with counsel of its choice at its own expense. Without limitation
of the foregoing, if BII finds it necessary or desirable to join Epizyme as a
party to any such action, Epizyme shall execute all papers and perform such acts
as shall be reasonably required at BII’s expense. If BII elects (in a written
communication submitted to Epizyme within a reasonable amount of time after
notice of the alleged Patent infringement) not to defend or control the defense
of, or otherwise fails to initiate and maintain the defense of, any such claim,
suit or proceeding, within such time periods so that Epizyme is not prejudiced
by any delays, Epizyme, in consultation with the Patent Liaisons, may conduct
and control the defense of any such claim, suit or proceeding at its own
expense. Each Party’s Patent Liaison shall keep the other Party’s Patent Liaison
reasonably informed of all material developments in connection with any such
claim, suit or proceeding. Each Party’s Patent Liaison shall provide the other
Party’s Patent Liaison with copies of all pleadings filed in such action and to
allow the other Party’s Patent Liaison a reasonable opportunity to participate
in the defense of the claims. In case either Party desires to submit a
counterclaim in such defensive action, Section 8.3 (Enforcement of Patents)
applies in case such counterclaim concerns the enforcement of an Epizyme Patent,
Joint Patent or BII Patent, including with respect to any recoveries realized as
a result of such counterclaim.

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8.5.Invalidity or Unenforceability Defenses or Actions.

8.5.1Notice. Each Party shall promptly notify the other Party in writing of any
alleged or threatened assertion of invalidity or unenforceability of any of the
Epizyme Patents, BII Patents or Joint Patents by a Third Party, in each case in
the Territory and of which such Party becomes aware, which assertion arises
outside of the context of an enforcement proceeding under Section 8.3
(Enforcement of Patents).

8.5.2Epizyme Product Patents and Joint Patents. BII, in consultation with the
Patent Liaisons, shall have the first right, but not the obligation, to defend
and control the defense of the validity and enforceability of the Epizyme
Product Patents or Joint Patents at its own expense in the Territory. Epizyme
may participate in any such claim, suit or proceeding in the Territory with
counsel of its choice at its own expense; provided that BII shall retain control
of the defense in such claim, suit or proceeding. If BII elects not to defend or
control the defense of the Epizyme Product Patents or Joint Patents in a suit
brought in the Territory, or otherwise fails to initiate and maintain the
defense of any such claim, suit or proceeding, then Epizyme, in consultation
with the Patent Liaisons, may conduct and control the defense of any such claim,
suit, or proceeding at its own.

8.5.3Other Epizyme Patents. Epizyme, in consultation with the Patent Liaisons,
shall have the sole right to defend and control the defense of the validity and
enforceability of the Epizyme Patents (other than the Epizyme Product Patents,
which are handled pursuant to Section 8.5.2 (Epizyme Product Patents and Joint
Patents)) and, without consulting the Patent Liaisons, the Epizyme Carve-Out
Patents, with respect to each, at its own expense in the Territory.
Notwithstanding the foregoing, Epizyme shall not take any action or fail to take
any action, in connection with the defense of any Epizyme Carve-Out Patent that
may have, or actually results in, any detrimental effect upon the patentability,
validity or enforceability of any Patent Right Covering Compounds or Products.
Epizyme shall ensure that all obligations of Epizyme under this Agreement with
respect to the Epizyme Carve-Out Patents will be placed upon any Third Party who
secures rights with respect to the defense of the Epizyme Carve-Out Patents.

8.5.4BII Product Patents. BII, in consultation with the Patent Liaisons, shall
have the first right, but not the obligation, to defend and control the defense
of the validity and enforceability of the BII Product Patents at its own expense
in the Territory. Epizyme may participate in any such claim, suit or proceeding
in the Territory with counsel of its choice at its own expense; provided that
BII shall retain control of the defense in such claim, suit or proceeding. If
BII elects not to defend or control the defense of the BII Product Patents in a
suit brought in the Territory, or otherwise fails to initiate and maintain the
defense of any such claim, suit or proceeding, then Epizyme, in consultation
with the Patent Liaisons, may conduct and control the defense of any such claim,
suit, or proceeding at its own expense.

8.5.5Other BII Patents. BII, in consultation with the Patent Liaisons, shall
have the sole right to defend and control the defense of the validity and
enforceability of the BII Patents (other than the BII Product Patents, which are
handled pursuant to Section 8.5.4 (BII Product Patents)) at its own expense in
the Territory.

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8.5.6Cooperation. Each Party shall assist and cooperate with the other Party,
including through its Patent Liaison, as such other Party may reasonably request
from time to time in connection with its activities set forth in this Section
8.5 (Invalidity or Unenforceability Defenses or Actions), 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’s Patent Liaison and shall keep the other Party’s Patent
Liaison reasonably informed of any steps taken, including by providing the other
Party’s Patent Liaison with copies of all documents filed in connection with
such defense, claim or counterclaim. In connection with the activities set forth
in this this Section 8.5 (Invalidity or Unenforceability Defenses or Actions),
each Party’s Patent Liaison shall consult with the other Party’s Patent Liaison
as to the strategy for the defense of the Epizyme Patents, BII Patents and Joint
Patents, but the Party having control of such proceeding as specified in this
Section 8.5 (Invalidity or Unenforceability Defenses or Actions) shall have
final decision making authority with respect thereto.

8.6.Third Party Licenses. If, in the reasonable opinion of a Party, the
Development, Manufacture or Commercialization of any Compound or Product by the
Parties or 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 the Territory,  then (i) with respect to the
BII Compound and BII Product in the Territory, BII has the sole right to
negotiate and obtain a license from such Third Party for BII or its Affiliates,
or its and their Sublicensees, to Develop, Manufacture and Commercialize BII
Compounds and BII Products in the Territory; provided that, BII shall be solely
responsible for any Third Party Payments owed in connection with such license
pursuant to Section 5.1 (BII Controlled Project), subject to Section 7.4.3(b)
(Reductions), (ii) with respect to the Joint Compound or Joint Product in the
ROW, BII has the sole right to negotiate and obtain a license from such Third
Party for BII or its Affiliates, or its and their Sublicensees, to Develop,
Manufacture and Commercialize Joint Compounds and Joint Product in the ROW,
subject to Section 7.4.3(b) (Reductions) and (iii) with respect to the Joint
Compound and Joint Product in the U.S., BII will have the right to negotiate and
obtain a license from such Third Party for either Party or its Affiliates, and
its and their Sublicensees, to Develop, Manufacture and Commercialize Joint
Compounds and Joint Products in the United States; provided that (i) BII will
keep Epizyme reasonably informed as to the status of such negotiations,
including by providing Epizyme with copies thereof, and will reasonably consider
any comments offered by Epizyme with respect thereto and (ii) any Third Party
Payments owed in connection with such license shall be included in Allowable
Expenses and the Parties shall share such Third Party Payments consistent with
Section 5.2.2(a)(iv) (Allocation).

8.7.Product Marks.

8.7.1Ownership and Prosecution of Product Marks. BII will own all right, title,
and interest to the Product Marks in the Territory, and will be responsible for
the preparation, filing, prosecution and maintenance thereof. All costs and
expenses of registering, prosecuting and maintaining the Product Marks will be
borne solely by BII. Epizyme will provide all assistance and documents
reasonably requested by BII in support of its prosecution, registration and
maintenance of the Product Marks.

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8.7.2Enforcement of Product Marks. BII will have the sole right and
responsibility for taking such action as BII deems necessary against a Third
Party based on any alleged, threatened or actual infringement, dilution,
misappropriation or other violation of, or unfair trade practices or any other
like offense relating to, the Product Marks by a Third Party in the Territory.
BII will bear the costs and expenses relating to any enforcement action
commenced pursuant to this Section 8.7.2 (Enforcement of Product Marks) and any
settlements and judgments with respect thereto, and will retain any damages or
other amounts collected in connection therewith.

8.7.3Third Party Claims. BII will have the sole right and responsibility for
defending against any alleged, threatened or actual claim by a Third Party that
the use or registration of the Product Marks in the Territory infringes,
dilutes, misappropriates or otherwise violates any Trademark or other right of
that Third Party or constitutes unfair trade practices or any other like
offense, or any other claims as may be brought by a Third Party against a Party
in connection with the use of the Product Marks with respect to a Product in the
Territory. BII will bear the costs and expenses relating to any defense
commenced pursuant to this Section 8.7.3 (Third Party Claims) and any
settlements and judgments with respect thereto, and will retain any damages or
other amounts collected in connection therewith.

8.7.4Notice and Cooperation. Each Party will provide to the other Party prompt
written notice of any actual or threatened infringement of the Product Marks in
the Territory and of any actual or threatened claim that the use of the Product
Marks in the Territory violates the rights of any Third Party. Each Party agrees
to cooperate fully with the other Party with respect to any enforcement action
or defense commenced pursuant to this Section 8.7 (Product Marks).

8.8.Inventor’s Remuneration. Each Party will be solely responsible for any
remuneration that may be due to such Party’s inventors under any applicable
inventor remuneration laws.

ARTICLE 9
Pharmacovigilance and Safety

9.1.Pharmacovigilance. Within [**] after JSC approval of a Joint Development
Plan and Budget that includes a Clinical Trial to be sponsored by Epizyme, the
Parties shall enter into an agreement to initiate a process for the exchange of
safety data (including post-marketing spontaneous reports received by each Party
and its Affiliates) in a mutually agreed format in order to monitor the safety
of the Compounds, Products and Diagnostic Products and to meet reporting
requirements with any applicable Regulatory Authority.

9.2.Global Safety Database. BII shall be responsible for setting up, holding and
maintaining (at BII’s sole cost and expense) the global safety database for
Compounds, Products and Diagnostic Products; provided that Epizyme shall have
the right to hold and maintain a parallel safety database for the Joint
Compound, Joint Product and Diagnostic Products for the Joint Compound only if
required by Applicable Laws. Each Party shall provide the other Party with all
Information necessary or desirable for the other Party to comply with its
pharmacovigilance responsibilities in the Territory, including, as applicable,
any adverse drug

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experiences, from pre-clinical or clinical laboratory, animal toxicology and
pharmacology studies, Clinical Trials and commercial experiences with a
Compound, Product or Diagnostic Product, in each case, in the form reasonably
requested by the other Party. Each Party’s and its Affiliates’ and Sublicensees’
costs incurred in connection with receiving, recording, reviewing,
communicating, reporting and responding to adverse events for Joint Products in
the United States shall be included in Allowable Expenses so long as such
actions are consistent with the Joint Commercialization Plan and Budget.

ARTICLE 10
Confidentiality and Non-Disclosure

10.1.Confidentiality Obligations. At all times during the Term and for a period
of [**] following termination or expiration hereof in its entirety, each Party
will, and will cause its Affiliates and its and their respective officers,
directors, employees and agents to, keep confidential and not publish or
otherwise disclose to a Third Party and not use, directly or indirectly, for any
purpose, any Confidential Information furnished or otherwise made known to it,
directly or indirectly, by the other Party, except to the extent such disclosure
or use is expressly permitted by the terms of this Agreement or is necessary for
the performance of, or the exercise of such Party’s rights under, this
Agreement. Notwithstanding the foregoing, to the extent the receiving Party can
demonstrate by documentation or other competent proof, the confidentiality and
non-use obligations under this Section 10.1 (Confidentiality Obligations) with
respect to any Confidential Information will not include any Information that:

10.1.1has been published by a Third Party or otherwise is or hereafter becomes
part of the public domain by public use, publication, general knowledge or the
like through no wrongful act, fault or negligence on the part of the receiving
Party;

10.1.2have been in the receiving Party’s possession prior to disclosure by the
disclosing Party without any obligation of confidentiality with respect to such
Information;

10.1.3is subsequently received by the receiving Party from a Third Party without
restriction and without breach of any agreement between such Third Party and the
disclosing Party;

10.1.4that is generally made available to Third Parties by the disclosing Party
without restriction on disclosure; or

10.1.5have been independently developed by or for the receiving Party without
reference to, or use or disclosure of, the disclosing Party’s Confidential
Information.

Specific aspects or details of Confidential Information will not be deemed to be
within the public domain or in the possession of the receiving Party merely
because the Confidential Information is embraced by more general Information in
the public domain or in the possession of the receiving Party. Further, any
combination of Confidential Information will not be considered in the public
domain or in the possession of the receiving Party merely because individual
elements of such Confidential Information are in the public domain or in the
possession of the receiving Party unless the combination and its principles are
in the public domain or in the possession of the receiving Party.

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10.2.Permitted Disclosures. Each Party may disclose the Confidential Information
of the other Party that is received in connection with this Agreement to the
extent that such disclosure is:

10.2.1in the reasonable opinion of the receiving Party’s legal counsel, required
to be disclosed pursuant to Applicable Law or a valid order of a court of
competent jurisdiction or other supra-national, federal, national, regional,
state, provincial and local governmental body of competent jurisdiction,
(including by reason of filing with securities regulators, but subject to
Section 10.5 (Agreement Redactions)); provided that the receiving Party will
first have given prompt written notice (and to the extent possible, at least
[**] notice) to the disclosing Party and given the disclosing Party a reasonable
opportunity to take whatever action it deems necessary to protect its
Confidential Information (for example, 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 governmental body or, if disclosed, be used only for
the purposes for which the order was issued). In the event that no protective
order or other remedy is obtained, or the disclosing Party waives compliance
with the terms of this Agreement, the receiving Party will furnish only that
portion of Confidential Information which the receiving Party is advised by
counsel is legally required to be disclosed;

10.2.2made by or on behalf of the receiving Party to the Regulatory Authorities
as required in connection with any filing, application or request for Regulatory
Approval in accordance with the terms of this Agreement; provided that
reasonable measures will be taken to assure confidential treatment of such
Confidential Information to the extent practicable and consistent with
Applicable Law;

10.2.3made by or on behalf of the receiving Party to a Patent authority as may
be reasonably necessary or useful for purposes of obtaining, defending or
enforcing a Patent in accordance with the terms of this Agreement; provided that
reasonable measures will be taken to assure confidential treatment of such
Confidential Information, to the extent practicable and consistent with
Applicable Law;

10.2.4made by the receiving Party to: (a) its Board of Directors, accountants
and legal advisors who have a need to know the disclosing Party’s Confidential
Information, (b) its Affiliates who have a need to know the disclosing Party’s
Confidential Information, however never to any Affiliates who control a [**]
Competing Product or [**] Competing Product and always conforming with the
exclusivity obligations under Section 4.4 (Exclusivity) of this Agreement or (c)
its or their consultants, advisors, Sublicensees or Contractors who have a need
to know the disclosing Party’s Confidential Information in connection with the
research, Development, Manufacture, Commercialization, use or other Exploitation
of Compounds, Products or Diagnostic Products; provided that such Persons will
be subject to obligations of confidentiality and non-use with respect to such
Confidential Information at least as protective to the disclosing Party as the
obligations of confidentiality and non-use of the receiving Party pursuant to
this Agreement;

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10.2.5made by the receiving Party to its actual investors, bankers, financial
advisors, lenders or financing sources (and their respective attorneys and
professional advisors) on a need to know basis, each of whom prior to disclosure
must be subject to appropriate obligations of confidentiality and non-use
equivalent in scope and time to those set forth in this Agreement; provided that
a disclosure pursuant to this Section 10.2.5 is limited to (a) a high-level
status overview of and projections for the research, Development, Manufacturing
or Commercialization of Compounds and Products, and the actual and projected
financial payments to and from Epizyme with respect thereto, and, for clarity,
does not include chemical structures, chemical names and molecular weights of
Compounds and (b) the terms of this Agreement, but excluding the terms of the
Research Plan, Joint Development Plan and Budget, Joint Commercialization Plan
and Budget, the SoLO Criteria or SoD Criteria,  unless such investors, bankers,
financial advisors, lenders or financing sources (or their respective attorneys
and professional advisors) request disclosure of such terms, in which case, such
terms shall be disclosed only after suitable redactions have been made and have
been agreed to by BII, such agreement not to be unreasonably withheld;

10.2.6made by the receiving Party to its bona fide prospective investors,
acquirers, lenders or financing sources on a need to know basis in connection
with any transaction, each of whom prior to disclosure must be subject to
appropriate obligations of confidentiality and non-use equivalent in scope and
time to those set forth in this Agreement; provided that a disclosure pursuant
to this Section 10.2.6 is limited to (a) a high-level status overview of and
projections for the research, Development, Manufacturing or Commercialization of
Compounds and Products, and the actual and projected financial payments to and
from Epizyme with respect thereto, and, for clarity, does not include chemical
structures, chemical names and molecular weights of Compounds and (b) to the
extent necessary for the relevant transaction, the terms of this Agreement, but
excluding the terms of the Research Plan, Joint Development Plan and Budget,
Joint Commercialization Plan and Budget, the SoLO Criteria or SoD Criteria,
unless such prospective investors, acquirers, lenders or financing sources
request disclosure of such terms, in which case, such terms shall be disclosed
only after suitable redactions have been made and have been agreed to by BII,
such agreement not to be unreasonably withheld; and

10.2.7made by the receiving Party to the extent mutually agreed to in writing by
the Parties.

10.3.Use of Name. Except as expressly provided herein, neither Party will
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. The
restrictions imposed by this Section 10.3 (Use of Name) will not prohibit either
Party from making any disclosure identifying the other Party that, in the
opinion of the disclosing Party’s counsel, is required by Applicable Law;
provided that such Party will submit the proposed disclosure identifying the
other Party in writing to the other Party as far in advance as reasonably
practicable (and in no event less than [**] prior to the anticipated date of
disclosure) so as to provide a reasonable opportunity to comment thereon.

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10.4.Press Releases. The Parties have agreed upon the content of a joint press
release, which shall be issued substantially in the form attached hereto as
Schedule 10.4, the release of which the Parties shall coordinate to issue such
release as soon as practicable after execution of this Agreement. Subject to the
other provisions of this Agreement, no other press release, public statement or
public disclosure concerning the existence or terms of this Agreement shall be
made, either directly or indirectly, by either Party, without first obtaining
the written approval of the other Party, such written approval not to be
unreasonably withheld (for clarity, either Party may disclose in any subsequent
press release the contents of Schedule 10.4 without having to obtain the other
Party’s consent, provided such press release is limited to disclosing only the
Information contained in Schedule 10.4); provided that, in connection with
issuing subsequent press releases, Epizyme may disclose its achievement of any
Milestone Event and receipt of any Milestone Payment, including the amount
thereof without obtaining BII’s prior written consent. Epizyme may only disclose
in a press release (i) material developments with respect to the Joint Product
in the United States or (ii) information required to be disclosed as described
in Section 10.2.1, with respect to (i)-(ii), provided it first obtains BII’s
prior written consent, not to be unreasonably withheld. Subject to Section
10.2.1, in no event shall any such subsequent press release, public statement or
public disclosure by a Party disclose, if previously undisclosed, the identity
of any Compound or Product, the stage of development of any Product or the
financial terms of this Agreement. Once any public statement or public
disclosure has been approved in accordance with this Section 10.4 (Press
Release), then either Party may appropriately communicate information contained
in such permitted statement or disclosure.

10.5.Agreement Redactions. Notwithstanding any of the provisions of this ARTICLE
10 (Confidentiality and Non-Disclosure), a Party may disclose the existence and
terms of this Agreement (however, excluding, as far as legally possible, any and
all information and terms contained within the Agreement) or the Parties’
activities under this Agreement, where required, as reasonably determined by the
legal counsel of the disclosing Party, by Applicable Law, by applicable stock
exchange regulation or by order or other ruling of a competent court; provided
that, to the extent practicable, the other Party shall be given [**] advance
notice of any such legally required disclosure, so such other Party may provide
comments to the disclosing Party, and the disclosing Party shall use their
commercially reasonable efforts to reasonably consider such comments provided by
such other Party on the proposed disclosure, and the disclosing Party shall use
reasonable efforts to redact the information contained within the Agreement in a
consistent manner and consistent with the intentions of this Agreement that
information shall not be disclosed unless absolutely required by Applicable Law
or regulations or if the other Party provides its prior written consent. In case
either Party is obliged to publish the Agreement as a “material agreement” in
accordance with the U.S. stock exchange regulations (“SEC Filing”) or any other
similar stock exchange regulations throughout the Territory, the Agreement shall
be redacted by the filing Party as far as legally possible, and the filing Party
shall cooperate with the other Party reasonably in advance to such SEC Filing to
enable the other Party to review and comment on the scope of such redaction, all
in accordance with the requirements found in the immediately preceding sentence.

10.6.Publications. Within [**] of the Effective Date, the Parties, through the
JSC, shall develop policies and procedures (“Publication Policies”) for any
publication with respect to Development of Compounds (including any research
results arising from the conduct of Research Activities under the Research
Plan), Products and Diagnostic Products, including the

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results of Clinical Trials and disclosure in applicable clinical trial
registries, which policies and procedures shall be consistent with the Parties’
respective policies and procedures for publication and disclosure of the results
of Clinical Trials, with disputes to be resolved in favor of the policy that
provides for the narrowest disclosure of such results. All abstracts,
manuscripts and presentations (including Information to be presented verbally)
that disclose results of the Development of Compounds (including any research
results arising from the conduct of Research Activities under the Research
Plan), Products and Diagnostic Products, shall be reviewed and approved by the
JSC in accordance with the Publication Policies. Notwithstanding the foregoing,
each Party shall provide to the other Party (through the JSC) the opportunity to
review each of the submitting Party’s proposed abstracts, manuscripts or
presentations (including Information to be presented verbally) that relate to
any activities under the Research Plan or otherwise with respect to a Compound,
Product or Diagnostic Product at least [**] prior to its intended presentation
or submission for publication and such submitting Party agrees, upon written
request from the other Party given within such [**] period, as applicable, not
to submit such abstract or manuscript for publication or to make such
presentation until the other Party is given up to [**] from the date of such
written request to seek appropriate Patent protection for any material in such
publication or presentation that it reasonably believes, in good faith, may be
patentable. Both Parties understand that a reasonable commercial strategy may
require the delay of publications of information or the filings of patent
applications with respect to activities performed or results obtained pursuant
to this Agreement, and in such instances, such information shall not be
published until a patent application is filed or it is otherwise deemed suitable
for publication by both Parties, and always subject to BII’s rights to determine
the timing of filings of Joint Counsel Patent Rights as specified in Section
8.2.4(a) (Joint Patents and Epizyme Product Patents). For clarity and
notwithstanding anything to the contrary contained in this Section 10.6
(Publications), BII and its Affiliates may publish or present results, data or
scientific findings of any of their activities performed with respect to the BII
Compound or BII Product [**] has been achieved with respect to such BII Compound
or BII Product without the prior review or consent of Epizyme, unless Epizyme is
required to be or is otherwise acknowledged in or listed as an author of such
publication or presentation, in which event BII may not make such presentation
or publication without Epizyme’s prior written consent, such consent not to be
unreasonably withheld. Each Party also shall have the right to require that any
of its Confidential Information (but not the results of Clinical Trials that
have been approved for disclosure pursuant to the Publication Policies) that is
disclosed in any such proposed publication or presentation be deleted prior to
such publication or presentation. Any publication shall include recognition of
the contributions of the other Party according to standard practice for
assigning scientific credit, either through authorship or acknowledgement, as
may be appropriate.

10.7.Confidentiality Redaction. Each Party also shall have the right to require
that any of its Confidential Information (but not the results of Clinical Trials
that have been approved for disclosure pursuant to the Publication Policies)
that is disclosed in any such proposed publication or presentation be deleted
prior to such publication or presentation. Any publication or presentation shall
include recognition of the contributions of the other Party according to
standard practice for assigning scientific credit, either through authorship or
acknowledgement, as may be appropriate.

10.8.Survival. All Confidential Information will continue to be subject to the
terms of this Agreement for the period set forth in Section 10.1
(Confidentiality Obligations).

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ARTICLE 11
Representations and Warranties

11.1.Mutual Representations and Warranties. Each Party hereby represents and
warrants to the other, as of the Effective Date, that:

11.1.1it is a corporation duly organized, validly existing, and in good standing
under the laws of the jurisdiction of its organization, and has all requisite
power and authority, corporate or otherwise, to execute, deliver and perform
this Agreement;

11.1.2the execution and delivery of this Agreement and the performance by it of
the transactions contemplated hereby have been duly authorized by all necessary
corporate action, and do not violate (a) such Party’s charter documents, bylaws,
or other organizational documents, (b) any agreement, instrument, or contractual
obligation to which such Party is bound, (c) any requirement of any Applicable
Law or (d) any order, writ, judgment, injunction, decree, determination, or
award of any court or governmental agency presently in effect applicable to such
Party;

11.1.3this Agreement is a legal, valid and binding obligation of such Party
enforceable against it in accordance with its terms and conditions, subject to
the effects of bankruptcy, insolvency, or other laws of general application
affecting the enforcement of creditor rights, judicial principles affecting the
availability of specific performance, and general principles of equity (whether
enforceability is considered a proceeding at law or equity);

11.1.4it is not under any obligation, contractual or otherwise, to a Person that
conflicts with or is inconsistent with the terms of this Agreement, or that
would impede the diligent and complete fulfillment of its obligations hereunder;

11.1.5to its knowledge, it has not (i) employed and has not used a Contractor or
consultant that has employed, any Person debarred by the FDA (or subject to
similar sanctions of the EMA or other Regulatory Authority) or (ii) employed any
Person that is the subject of an FDA debarment investigation or proceeding (or
similar proceeding of the EMA or other Regulatory Authority), with respect to
(i)-(ii), in the conduct of any pre-clinical activities with respect to
Compounds;

11.1.6no consent of any Third Party is required for such Party to grant the
licenses and rights granted to the other Party under this Agreement or to
perform its obligations hereunder; and

11.1.7all of such Party’s personnel and employees and Third Parties, including
Contractors, hired by such Party and involved in activities under this Agreement
are, or when hired will be, under a written agreement whereby they have
presently assigned to such Party any right that they may have in any invention
first invented, discovered, made, conceived or reduced to practice while
employed by or working on behalf of such Party in the conduct of activities
pursuant to the Research Plan, or in the Development, Manufacture or
Commercialization of any of such Compounds or Products, and all intellectual
property rights therein.

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11.2.Additional Representations and Warranties of Epizyme. Epizyme further
represents and warrants to BII, as of the Effective Date, that:

11.2.1Epizyme has the right to grant all rights and license it purports to grant
to BII with respect to the Epizyme Technology under this Agreement;

11.2.2Epizyme has not granted any right or license to any Third Party relating
to any Epizyme Technology that would conflict with or interfere with or limit
the scope of any rights or licenses granted to BII hereunder;

11.2.3Epizyme has not granted any liens or security interest on the Epizyme
Technology that would limit the scope of any rights or licenses granted to BII
hereunder;

11.2.4Neither Epizyme nor its Affiliates have knowledge of or have received any
written notice of any claim that any Patent or trade secret right Controlled by
a Third Party would be infringed or misappropriated by the Manufacture, use,
sale, offer for sale or importation of the Compounds or Products, as
contemplated by this Agreement;

11.2.5To Epizyme’s knowledge, the Epizyme Technology is not being infringed or
misappropriated by a Third Party; and

11.2.6The inventions claimed or covered by the Epizyme Patents existing as of
the Effective Date (a) were not conceived, discovered, developed, or otherwise
made in connection with any research activities funded, in whole or in part, by
the federal government of the United States or any agency thereof, (b) are not a
“subject invention” as that term is described in 35 U.S.C. Section 201(f) and
(c) are not otherwise subject to the provisions of the Bayh-Dole Act.

11.3.Mutual Covenants. Each Party hereby covenants to the other Party, as of the
Effective Date, that:

11.3.1all of its and its Affiliates’ employees who are working under this
Agreement will presently 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;

11.3.2to the best of its knowledge, without further duty of inquiry, such Party
will not (a) employ or use any Contractor or consultant that employs any Person
debarred by the FDA (or subject to similar sanction of the EMA or other
Regulatory Authority) or (b) employ any Person that is the subject of an FDA
debarment investigation or proceeding (or similar proceeding of the EMA or other
Regulatory Authority), in each of (i)-(ii), in the conduct of its activities
under this Agreement;

11.3.3it will perform or cause to be performed, its Research Activities and any
activities assigned to it under the Joint Development Plan and Budget and Joint
Commercialization Plan and Budget, in good scientific manner and in compliance
with all Applicable Laws; and

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11.3.4neither Party shall, during the Term, enter into an agreement with a Third
Party, or grant any right or license to any Third Party relating to any of the
intellectual property rights it Controls, or otherwise encumber such
intellectual property rights it Controls, that would conflict with any of the
rights, obligations or licenses granted to the other Party hereunder.

11.4.DISCLAIMER OF WARRANTIES. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH
HEREIN, NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES,
EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR
OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER
WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY,
MERCHANTABILITY, OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS
TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL
PROPERTY RIGHTS OF THIRD PARTIES.

ARTICLE 12
Indemnity

12.1.Indemnification of Epizyme. BII will indemnify Epizyme, its Affiliates and
its and their respective directors, officers, employees and agents (the “Epizyme
Indemnitees”) and defend and save each of them harmless, from and against any
and all losses, damages, liabilities, penalties, costs and expenses (including
reasonable attorneys’ fees and expenses) (collectively, “Losses”) in connection
with any and all suits, investigations, claims or demands of Third Parties
(collectively, “Third Party Claims”) incurred by or rendered against the Epizyme
Indemnitees arising from or occurring as a result of: (a) the breach by BII or
its Affiliates of this Agreement; (b) the fraud, gross negligence or willful
misconduct on the part of BII or its Affiliates or their respective directors,
officers, employees and agents in performing its or their obligations under this
Agreement; (c) the use of Product Marks in connection with the Exploitation of
Products in the Territory; (d) the Exploitation of BII Products in the Territory
by BII or its Affiliates; and (e) the Exploitation of Joint Products in the
Territory by BII or its Affiliates; provided that, in the case of clauses
(a)-(e), for those Losses for which Epizyme, in whole or in part, has an
obligation to indemnify BII pursuant to Section 12.2 (Indemnification of BII)
hereof, as to which Losses each Party will indemnify the other to the extent of
their respective liability for such Losses.

12.2.Indemnification of BII. Epizyme will indemnify BII, its Affiliates and its
and their respective directors, officers, employees and agents (the “BII
Indemnitees”), and defend and save each of them harmless, from and against any
and all Losses in connection with any and all Third Party Claims incurred by or
rendered against the BII Indemnitees arising from or occurring as a result of:
(a) the breach by Epizyme or its Affiliates of this Agreement; (b) the fraud,
gross negligence or willful misconduct on the part of Epizyme or its Affiliates
or its or their respective directors, officers, employees and agents in
performing its obligations under this Agreement; and (c) the Exploitation of
Joint Products in the Territory by Epizyme or its Affiliates; provided that, in
the case of clauses (a)-(c), for those Losses for which BII, in whole or in
part, has an obligation to indemnify Epizyme pursuant to Section 12.1
(Indemnification of Epizyme) hereof, as to which Losses each Party will
indemnify the other to the extent of their respective liability for the Losses.

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12.3.Procedure. In the event of a claim by a Third Party against a Person
entitled to indemnification under this Agreement (“Indemnified Party”), the
Indemnified Party shall promptly notify the other Party (“Indemnifying Party”)
in writing of the claim and the Indemnifying Party shall undertake and solely
manage and control, at its sole expense, the defense of the claim, including any
settlement thereof. The Indemnified Party shall, at the Indemnifying Party’s
expense, reasonably cooperate with the Indemnifying Party in connection with the
defense of such claim and may, at its option and expense, be represented in any
such action or proceeding by counsel of its choice. The Indemnifying Party shall
not be liable for any litigation costs or expenses incurred by the Indemnified
Party without the Indemnifying Party’s written consent. The Indemnifying Party
shall not settle any such claim unless such settlement fully and unconditionally
releases the Indemnified Party from all liability relating thereto, unless the
Indemnified Party agrees in writing otherwise.

12.4.No Consequential Damages. EXCEPT (A) FOR THE FRAUD OR WILLFUL MISCONDUCT OR
GROSS NEGLIGENCE OF A PARTY, (B) FOR A PARTY’S BREACH OF ITS OBLIGATIONS UNDER
ARTICLE 10 (CONFIDENTIALITY AND NON-DISCLOSURE), (C) TO THE EXTENT ANY SUCH
DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM FOR WHICH A
PARTY PROVIDES INDEMNIFICATION UNDER THIS ARTICLE 12 (INDEMNITY) OR (D) A
PARTY’S BREACH OF SECTION 4.4 (EXCLUSIVITY), NEITHER PARTY NOR ANY OF ITS
AFFILIATES OR ITS OR THEIR SUBLICENSEES WILL BE LIABLE FOR INDIRECT, INCIDENTAL,
SPECIAL, EXEMPLARY, PUNITIVE OR CONSEQUENTIAL DAMAGES, INCLUDING LOSS OF PROFITS
OR BUSINESS INTERRUPTION, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER
IN CONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE IN
CONNECTION WITH OR ARISING IN ANY WAY OUT OF THE TERMS OF THIS AGREEMENT OR THE
TRANSACTIONS CONTEMPLATED HEREBY OR THE USE OF THE LICENSED CONSTRUCTS OR
LICENSED PRODUCT, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.

12.5.Insurance. Each Party will obtain and carry in full force and effect the
minimum insurance requirements set forth below, except that BII may
alternatively decide to self-insure itself in its sole discretion. Such
insurance (a) will be primary insurance with respect to each Party’s own
participation under this Agreement, (b) will be issued by a recognized insurer
rated by A.M. Best “A-VII” (or its equivalent) or better, or an insurer
pre-approved in writing by the other Party and (c) will list the other Party as
an additional named insured thereunder, as applicable.

12.5.1Types and Minimum Limits. The types of insurance, and minimum limits will
be:

(a)Any insurance policy that is required by any Applicable Law, including
workers compensation and employer’s liability policies where applicable.

(b)General liability insurance with a minimum limit of [**] Dollars ($[**]) per
occurrence and [**] Dollars ($[**]) in the aggregate; provided that beginning at
least [**] prior to the Initiation of any Clinical Trial Conducted by a Party,
such Party’s

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general liability insurance will also include (i) Clinical Trial insurance with
a minimum limit of [**] Dollars ($[**]) in the aggregate and (ii) cyber/network
liability insurance with a minimum limit of [**] Dollars ($[**]) in the
aggregate, in each case, to be maintained throughout the Conduct of any such
Clinical Trials.

12.5.2Certificates of Insurance. Upon request by a Party, the other Party will
provide Certificates of Insurance evidencing compliance with this Section 12.5
(Insurance), except to the extent BII decides to self-insure itself. The
insurance policies will be under an occurrence form, but if only a claims-made
form is available to a Party, then such Party will continue to maintain such
insurance after the expiration or termination of this Agreement for the longer
of (a) a period of [**] following termination or expiration of this Agreement in
its entirety, or (b) with respect to a particular Party, last sale of a Product
(or but for expiration or termination, would be considered a Product) sold under
this Agreement by a Party.

ARTICLE 13
Term and Termination

13.1.Term.

13.1.1Term. This Agreement shall commence on the Effective Date and continue,
unless terminated earlier pursuant to Section 13.2 (Termination), on a
Product-by-Product basis, until the last to expire Royalty Term for such
Product; provided that, with respect to the Joint Product in the U.S., this
Agreement shall continue until both Parties mutually agree to cease
Commercialization of the Joint Product in the U.S. (such period until this
Agreement has expired pursuant to this Section with respect to all Products, the
“Term”).

13.2.Termination.

13.2.1Termination of Agreement for Cause. This Agreement may be terminated at
any time during the Term, on a Target Project-by-Target Project basis, or in its
entirety should the alleged material breach concern both Target Projects, upon
written notice by either Party (the “Non-Defaulting Party”) upon the material
breach of the other Party (the “Defaulting Party”), which material breach
remains uncured for [**] (or [**] in the event of  non-payment) after written
notice requesting cure of such material breach. The Non-Defaulting Party shall
provide written notice to the Defaulting Party, which notice shall identify the
material breach, the intent to so terminate and the actions or conduct that it
considers would be an acceptable cure of such material breach. If the Defaulting
Party disputes that a material breach has occurred or the actions that would
constitute an acceptable cure, then such dispute shall be resolved in accordance
with Section 14.7 (Dispute Resolution) and the cure period will be tolled during
the pendency of such dispute. If, as a result of such dispute resolution
process, it is determined that the alleged Defaulting Party committed a material
breach and the Defaulting Party does not cure such material breach within [**]
(or [**] in the event of a non-payment) after the date of such dispute
resolution award (but in no event less than the [**] or [**] cure periods
described above) (the “Additional Cure Period”), then such termination shall be
effective as of the expiration of the Additional Cure Period. If the Parties
dispute whether such material breach was so cured, either Party alone may
request the same tribunal to determine whether it was so cured, and the Parties
shall cooperate to allow such determination to be made within [**] after

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such request by either Party. Any such dispute resolution proceeding does not
suspend any obligation of either Party hereunder, and each Party shall use
reasonable efforts to mitigate any damage. If, as a result of any such dispute
resolution proceeding, it is determined that the alleged Defaulting Party did
not commit such material breach (or such material breach was cured in accordance
with this Section), then no termination shall be effective, and this Agreement
shall continue in full force and effect.

13.2.2Termination if BII Challenges Epizyme Patents. If BII or any of its
Affiliates or Sublicensees, (a) initiates or requests an interference,
post-grant review, derivation proceeding or opposition proceeding against any
Epizyme Patent, (b) makes, files or maintains any claim, demand, lawsuit or
cause of action to challenge the validity, enforceability, patentability or
scope of any claim within any Epizyme Patent in a tribunal or forum or (c)
opposes any extension of, or the grant of a supplementary protection certificate
with respect to, any Epizyme Patent, with respect to (a)-(c), Epizyme shall have
the right to terminate this Agreement (i) on a Target Project-by-Target Project
basis, as it concerns the subject matter covered under the challenged Epizyme
Patent or (ii) in its entirety, if the challenged Epizyme Patent concerns both
Target Projects, with respect to each, and upon [**] written notice to BII. Any
such termination shall only become effective if BII or its Affiliates or
Sublicensees, as applicable, (1) have not withdrawn such action before the end
of the above notice period, (2) withdrew the action before the end of the above
notice period but the action was not terminated as a result of such withdrawal
or (3) with respect to any BII Sublicensee, BII has not terminated its agreement
with such Sublicensee before the end of the above notice period. The Parties
acknowledge and agree that it shall not be grounds for terminating this
Agreement if BII or any of its Affiliates or Sublicensees challenges the
validity, enforceability, patentability or scope of any claim within an Epizyme
Patent in defense of an action for infringement of such Epizyme Patent brought
by Epizyme or any of its Affiliates solely with respect to BII’s or its
Affiliates’ or Sublicensees’ activities outside the scope of this Agreement.

13.2.3Termination if Epizyme Challenges Patents Controlled by BII. If Epizyme or
any of its Affiliates (a) initiates or requests an interference, post-grant
review, derivation proceeding or opposition proceeding against any BII Patent,
(b) makes, files or maintains any claim, demand, lawsuit or cause of action to
challenge the validity, enforceability, patentability or scope of any claim
within any BII Patent in a tribunal or forum or (c) opposes any extension of, or
the grant of a supplementary protection certificate with respect to, any BII
Patent, with respect to (a)-(c), BII shall have the right to terminate this
Agreement (i) on a Target Project-by-Target Project basis, as it concerns the
subject matter covered under the challenged BII Patent or (ii) in its entirety,
if the challenged BII Patent concerns both Target Projects, with respect to
each, and upon [**] written notice to Epizyme. Any such termination shall only
become effective if Epizyme or its Affiliates, as applicable, (1) have not
withdrawn such action before the end of the above notice period or (2) withdrew
the action before the end of the above notice period but the action was not
terminated as a result of such withdrawal. The Parties acknowledge and agree
that it shall not be grounds for terminating this Agreement if Epizyme or any of
its Affiliates challenges the validity, enforceability, patentability or scope
of any claim within an BII Patent in defense of an action for infringement of
such BII Patent brought by BII or any of its Affiliates or Sublicensees solely
with respect to Epizyme’s or its Affiliates’ activities outside the scope of
this Agreement.

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13.2.4Termination by BII Without Cause. BII shall have the right to terminate
the Agreement, at any time, in its entirety or on a Target Project-by-Target
Project basis, (a) if terminating with respect to a Target Project during the
Research Period for such Target Project, upon [**] notice to Epizyme, (b) if
terminating with respect to a Target Project after the Research Period but prior
to [**] for such Target Project, upon [**] notice to Epizyme, (c) if terminating
with respect to a Target Project following [**] for such Target Project, [**]
notice to Epizyme and (d) if terminating in its entirety and neither Target
Project was the subject of a previous termination, then the corresponding notice
periods for each of the two Target Projects in subclauses (a) through (c) shall
separately apply, as applicable.

13.2.5Termination for Insolvency. In the event that either Party: (a) files for
protection under bankruptcy or insolvency laws; (b) makes an assignment for the
benefit of creditors; (c) appoints or suffers appointment of a receiver or
trustee over substantially all of its property that is not discharged within
[**] after such filing; (d) proposes a written agreement of composition or
extension of its debts; (e) proposes or is a party to any dissolution or
liquidation; (f) files a petition under any bankruptcy or insolvency act or has
any such petition filed against that is not discharged within [**] of the filing
thereof; or (g) admits in writing its inability generally to meet its
obligations as they fall due in the general course, then the other Party may
terminate this Agreement in its entirety effective immediately upon written
notice to such Party. All rights and licenses (collectively, the “Intellectual
Property”) granted under or pursuant to this Agreement are intended to be, and
will otherwise be deemed to be, for purposes of Section 365(n) of the United
States Bankruptcy Code (the “Bankruptcy Code”) or any analogous provisions in
any other country or jurisdiction, licenses of rights to “intellectual property”
as defined under Section 101(35A) of the Bankruptcy Code. The Parties agree that
the licensee of such intellectual property under this Agreement will retain and
may fully exercise all of its rights and elections under the Bankruptcy Code,
including Section 365(n) of the Bankruptcy Code, or any analogous provisions in
any other country or jurisdiction. All of the rights granted to either Party
under this Agreement will be deemed to exist immediately before the occurrence
of any bankruptcy case in which the other Party is the debtor. If a bankruptcy
proceeding is commenced by or against either Party under the Bankruptcy Code or
any analogous provisions in any other country or jurisdiction, the non-debtor
Party will be entitled to a complete duplicate of (or complete access to, as
appropriate) any intellectual property and all embodiments of such intellectual
property, which, if not already in the non-debtor Party’s possession, will be
delivered to the non-debtor Party within [**] of such request; provided that the
debtor Party is excused from its obligation to deliver the intellectual property
to the extent the debtor Party continues to perform all of its obligations under
this Agreement and the Agreement has not been rejected pursuant to the
Bankruptcy Code or any analogous provision in any other country or jurisdiction.

13.3.Effects of Termination.

13.3.1Termination by BII for Cause, Epizyme Patent Challenge or Epizyme
Insolvency. If BII has the right to terminate this Agreement with respect to a
specific Target Project or  in its entirety pursuant to Sections 13.2.1
(Termination of Agreement for Cause), Section 13.2.3 (Termination if Epizyme
Challenges Patents Controlled by BII) or Section 13.2.5 (Termination for
Insolvency), then BII may, in its sole discretion, elect either of the following
options, which will be applied on a Target Project-by-Target Project basis (if
BII

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has the right to terminate this Agreement with respect to a specific Target
Project) or with respect to both Target Projects (if BII has the right to
terminate this Agreement in its entirety)), and if BII has not provided written
notice of its election within [**] from the end of the relevant cure periods
under Sections 13.2.1 (Termination of Agreement for Cause) or Section 13.2.3
(Termination if Epizyme Challenges Patents Controlled by BII), as applicable,
then BII shall be deemed to have elected clause (a):

(a)BII may terminate this Agreement; provided that, in such event, (i) Sections
13.3.2(a)-13.3.2(d) shall apply and (ii) BII may solely determine whether or not
the Parties will, within [**] following BII’s written notice of its decision to
terminate, enter into a Transition Agreement that adheres to the requirements of
Sections 13.3.2(f) and, in connection with entering into such Transition
Agreement, the Parties shall negotiate with each other in good faith and set
forth in such Transition Agreement commercially reasonable consideration to be
paid by Epizyme to BII in connection with the assignments and licenses granted
to Epizyme in such Transition Agreement; provided, however, that if the Parties
are unable to reach agreement with respect to commercially reasonable
consideration to be paid to BII within [**] following BII’s written notice of
its decision to terminate, then the matter shall, at the request of either
Party, be submitted to arbitration using the process set forth in Schedule 13.3
to determine industry standard, commercially reasonable consideration, the
results of which shall be binding on the Parties, but in all instances, the
Parties agree that any such awarded consideration shall not be less than [**]
percent ([**]%) of any Milestone Payments and royalties that would otherwise
have been due and payable by BII to Epizyme; or

(b)(i) BII may elect not to terminate this Agreement and instead have this
Agreement, including  BII’s licenses pursuant to this Agreement, continue in
accordance with its terms; provided that, in such event, BII shall continue to
fulfill its Milestone Payment and royalty obligations as specified herein,
except that BII may reduce its Milestone Payments or royalty payments under
ARTICLE 7 (Payments and Records) by [**] percent ([**]%), which shall be BII’s
sole remedy with respect to such breach, (ii) Epizyme shall, within [**] after
the effective date of such termination, return or cause to be returned to BII,
copies of all BII’s Confidential Information provided by BII in connection with
this Agreement, except that Epizyme may retain one copy of BII’s Confidential
Information solely for legal archive purposes and to exercise the licenses
granted to Epizyme which survive termination of this Agreement, (iii) BII shall
be released of its ongoing disclosure and information exchange obligations under
this Agreement, except for information sharing that relates to (A) disclosure of
Joint Technology pursuant to Section 8.1.2 (Ownership of Joint Technology), (B)
the Prosecution and Maintenance of Epizyme Patents, BII Patents or Joint Patents
pursuant to Section 8.2 (Maintenance and Prosecution of Patents), (C)
enforcement of the Epizyme Patents, BII Patents or Joint Patents pursuant to
Section 8.3 (Enforcement of Patents), (D) infringement claims brought by Third
Parties pursuant to Section 8.4 (Infringement Claims by Third Parties), (E)
invalidity or unenforceability actions pursuant to Section 8.5 (Invalidity or
Unenforceability Defenses or Actions) or (F) a Party’s indemnification
obligation pursuant to ARTICLE 12 (Indemnification), (iv) the JSC and its
working groups shall be disbanded and (v) if the breach relates to the Joint
Product, then Epizyme shall be deemed to have provided an Opt-Out Notice to BII
with respect to the Joint Product and its Development and Commercialization
interests with respect to the United States pursuant to Section 5.2.5 (Epizyme
Opt-Out).

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13.3.2Termination by BII Without Cause or by Epizyme for Cause, BII Patent
Challenge or BII Insolvency. Upon termination of this Agreement by BII under
Section 13.2.4 (Termination by BII Without Cause) or by Epizyme under Section
13.2.1 (Termination of Agreement for Cause), Section 13.2.2 (Termination if BII
Challenges Epizyme Patents) or Section 13.2.5 (Termination for Insolvency), then
with respect to the terminated Target Project (if this Agreement is terminated
on a Target Project-by-Target Project basis) or with respect to both Target
Projects (if this Agreement is terminated in its entirety), as applicable:

(a)BII’s licenses pursuant to Section 6.2 (Grant to BII) shall terminate as of
the effective date of termination;

(b)Epizyme’s licenses pursuant to Section 6.1 (Grant to Epizyme) shall terminate
as of the effective date of termination;

(c)the Parties’ exclusivity obligations pursuant to Section 4.4 (Exclusivity)
shall terminate;

(d)each Party shall, within [**] after the effective date of termination,
destroy all copies of the other Party’s Confidential Information in its
possession and confirm such destruction in writing to the other Party; provided
that the destroying Party will be permitted to retain one copy of such
Confidential Information for the sole purpose of performing any continuing
obligations or exercising any continuing rights hereunder (and may make
additional copies of such Confidential Information for such purposes), as
required by Applicable Law or for bona fide archival purposes;

(e)BII shall have no obligation to Initiate any Clinical Trial that has not
already been Initiated as of the earlier of (i) the date notice was provided
regarding the termination or (ii) the Effective Date of termination, with
respect to each, but otherwise may have been planned (whether under the Joint
Development Plan and Budget or otherwise); and

(f)Upon Epizyme’s written request, such request to be made as soon as reasonably
practicable and no later than: (i) [**] after the effective date of termination
should Epizyme have terminated under Sections 13.2.1 (Termination of Agreement
for Cause), 13.2.2 (Termination if BII Challenges Epizyme Patents) or 13.2.5
(Termination for Insolvency or (ii) thirty (30) days following Epizyme’s receipt
of BII’s termination notice if BII is terminating under Section 13.2.4
(Termination by BII Without Cause), the Parties shall negotiate and conclude, in
good faith, within [**], a written transition agreement (the “Transition
Agreement”) pursuant to which BII and Epizyme will effect and coordinate a
transition of relevant obligations and rights. The Transition Agreement shall
provide (unless, in the case of clauses (1), (2) and (3) below, BII agrees to
assign, rather than provide, the items described in such clauses):

 

(1)

that BII shall provide to Epizyme with the right to use and to permit Third
Parties to use, to the extent allowed by Applicable Law, the following materials
within [**] following termination or as soon as reasonably possible

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thereafter: (i) a list of all terminated Compounds, Products or Diagnostic
Products (ii) the key samples of such Compounds, Products and Diagnostic
Products, (iii) data supporting Compound Development work on potential drug
substance and drug product, (iv) assay results and reports, including structural
biology reports and data from biochemical and biology (in vitro and in vivo),
pharmacology, toxicology, ADME/DMPK, safety, and Clinical Trial studies and (v)
notebook records or reports (or copies thereof) for Clinical Trials required to
support Regulatory Approvals;

 

(2)

that BII shall provide to Epizyme with the right to use and to permit Third
Parties to use, within [**] following termination or as soon as reasonably
possible thereafter, reports or data files and other results and reports
Controlled by BII as of the effective date of termination and generated in and
reasonably necessary for the continued Development, Manufacture or
Commercialization of Compounds, Products or Diagnostic Products for Compounds or
Products from terminated Target Projects, including pharmacology, toxicology,
biology, ADME/DMPK, safety, and Clinical Trial data and results, batch records,
formulation Information, and other Manufacturing-related Information as well as
any Patent-related documents that concern such Compounds, Products or Diagnostic
Products that have not already been disclosed to the Epizyme Patent Liaison
pursuant to the terms of this Agreement, and all of the above always subject to
any limitations as provided under Applicable Laws;

 

(3)

where permitted by Applicable Law, that (i) BII shall transfer to Epizyme with
the right to use and to permit Third Parties to use all of its right, title and
interest in all regulatory documentation then owned by BII and in its name that
are solely applicable to the terminated Target Project (if terminating on a
Target Project-by-Target Project basis) or both Target Projects (if terminating
in its entirety), including all INDs, Drug Approval Applications, reimbursement
approvals, pricing approvals, drug dossiers, master files and other regulatory
filings and regulatory correspondence with Regulatory Authorities related
thereto and (ii) BII shall, and does hereby, grant Epizyme a right of reference
to all regulatory documentation then owned by BII and in BII’s name that is
necessary or reasonably useful for Epizyme, its Affiliates or its Sublicensees
to Develop, Manufacture or Commercialize any Compounds, Products

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or Diagnostic Products arising from the terminated Target Project (if
terminating on a Target Project-by-Target Project basis) or both Target Project
(if terminating in its entirety) that is not transferred to Epizyme pursuant to
clause (i), as such regulatory documentation exists as of the effective date of
such termination;

 

(4)

that BII shall notify the applicable Regulatory Authorities and take any other
action reasonably necessary to effect the transfers and the right of reference
set forth in clauses (2) and (3) above;

 

(5)

that (i) if Epizyme elects, upon written notice to BII, not to continue a
Clinical Trial being Conducted by BII with respect to a terminated Target
Project as of the effective date of termination, then BII shall wind-down and
closeout such Clinical Trial at BII’s cost and expense, unless BII is prohibited
from doing so based on Applicable Law or by any Regulatory Authority and (ii) if
Epizyme elects, upon written notice to BII, to continue a Clinical Trial being
Conducted by BII with respect to a terminated Target Project as of the effective
date of termination, then, unless BII is prohibited from doing so based on
Applicable Law or by any Regulatory Authority, BII shall continue to Conduct
such Clinical Trial on behalf of Epizyme (A) if such Clinical Trial is for a BII
Product, then at Epizyme’s cost and (B) if such Clinical Trial is for a Joint
Product in the Territory, then BII will remain responsible for its share of
Committed Costs with respect to such Clinical Trial as set forth in Section
5.2.1(b)(iv) (Allocation). BII will Conduct such Clinical Trial on behalf of
Epizyme until such time as BII is able to transfer control of such Clinical
Trial to Epizyme without interruption, pursuant to the Transition Agreement;

 

(6)

that, at Epizyme’s written election, BII shall assign (or cause its Affiliates
to assign) to Epizyme all agreements with any Third Party that solely relate to
Compounds, Products or Diagnostic Products for Compounds or Products from
terminated Target Projects, including any agreement with respect to the
Manufacture of such Compounds, such Products or Diagnostic Products for such
Compounds or Products and any conduct of pre-clinical Development activities or
Clinical Trials for such Compounds, such Products or Diagnostic Products for
such Compounds or Products, such as agreements with contract research
organizations, clinical sites, investigators and

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manufacturing providers, unless, with respect to any such agreement, such
agreement (i) expressly prohibits such assignment or (ii) covers Clinical Trials
for Combination Products in which any active ingredient that is not a BII
Compound or Joint Compound is covered by Patents Controlled by BII or any of its
Affiliates. For the avoidance of doubt, to the extent that Epizyme does not
request such assignments be made by the earlier of (A) the effective date of the
Transition Agreement or (B) within [**] following the effective date of
termination, BII shall be entitled to terminate or take any other action with
respect to such Third Party agreements, as solely determined by BII;

 

(7)

that, at Epizyme’s written election, BII or its permitted Affiliates or
Contractors, as applicable, shall Manufacture and supply Compounds, Products or
Diagnostic Products for Compounds or Products from terminated Target Projects to
Epizyme (and only to the extent BII currently performs such activities for its
own account as of the effective date of termination) until the earlier of (i)
[**] following termination, (ii) the assignment to Epizyme of all Third Party
agreements that provide for the Manufacture of such Compounds, such Products or
Diagnostic Products for such Compounds or Products in accordance with clause (6)
or (iii) Epizyme qualifying a Third Party to Manufacture such Compounds, such
Products or Diagnostic Products for such Compounds or Products. The manufacture
and supply of any such Compounds, Products or Diagnostic Products for such
Compounds or Products directly by BII or its Affiliates shall be sold to Epizyme
at a negotiated price reflected in the Transition Agreement, not to exceed BII’s
costs plus [**] percent ([**]%) or, if supplied under a Third Party agreement
assigned under subclause (6) hereof, in accordance with the terms of such
agreement. If Epizyme requests that BII transfer to Epizyme processes,
documents, materials or Information, to the extent Controlled by BII as of the
effective date of termination, that are necessary for and used in the
Manufacture of Compounds, Products or Diagnostic Products for Compounds or
Products, this technology transfer shall be completed at Epizyme’s expense;

 

(8)

that, at Epizyme’s written election, BII shall sell to Epizyme, at cost, all or
any specified portion of any Compounds, Products and Diagnostic Products for
Compounds or Products from terminated Target Projects that are in inventory or
in-process as of the effective date of

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termination; provided, however, that, should any terminated Products be
commercialized by BII within any country in the Territory, BII shall have the
first right, if BII so elects, to sell such remaining inventory of such Product
within [**] following the effective date of termination, so long as BII
continues to sell such Product in accordance with the then-existing Joint
Commercialization Plan and Budget (including with respect to price) and pays the
royalties or share of profits to Epizyme in connection with such sales pursuant
to Section 5.2.2(c) (Profit Share) or Section 7.4 (Royalties), as applicable;

 

(9)

that BII shall assign to Epizyme all right, title, and interest of BII in each
Product Trademark;

 

(10)

(A) BII shall either, as solely determined by BII:

 

(i)

grant to Epizyme, exercisable from and after such termination, an exclusive,
worldwide, license, with the right to grant sublicenses (through multiple
tiers), under BII’s and its Affiliates’ interest in the Joint Know-How and Joint
Patents, solely to the extent that such licenses are necessary to research,
Develop, make, have made, use, offer for sale, sell, export and import
Compounds, Products and Diagnostic Products for Compounds and Products in the
Field in the Territory; or

 

(ii)

assign its rights and interest in the Joint Patents, and grant to Epizyme an
exclusive, worldwide, license, with the right to grant sublicenses (through
multiple tiers), under BII’s and its Affiliates’ interest in all other Joint
Know-How, solely to the extent that such assignment and license is necessary to
research, Develop, make, have made, use, offer for sale, sell, export and import
such Compounds, Products and Diagnostic Products for Compounds and Products in
the Field in the Territory.

(B) BII shall grant to Epizyme a worldwide, perpetual, irrevocable, exclusive,
sublicensable (through multiple tiers) license, under BII Know-How and BII
Patents, solely to the limited extent to continue to research,

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Develop, make, have made, use, offer for sale, sell, export and import such
Compounds, Products and Diagnostic Products for Compounds and Products in the
Field in the Territory.

(C) The Parties shall negotiate with each other, in good faith, commercially
reasonable consideration to be paid to BII concerning the rights, assignments
and licenses granted in clauses (A) and (B) above; provided, however, that, if
the Parties are unable to reach agreement within the allotted timeframe with
respect to the commercially reasonable consideration to be paid to BII, the
matter shall, at the request of either Party, be submitted to arbitration using
the process set forth in Schedule 13.3 to determine industry standard,
commercially reasonable consideration to be paid to BII, the results of which
shall be binding on the Parties, but in all instances, the Parties agree that
should BII have [**] for any Product, any such awarded consideration shall not
be less than [**] percent ([**]%) of any Milestone Payments and Royalties that
would otherwise have been due and payable by BII to Epizyme for such Product.

(D) In the event that BII grants to Epizyme an exclusive license or assigns
Joint Patents to Epizyme under Section 13.3.2(f)(10)(A), Epizyme shall be solely
responsible for the Prosecution and Maintenance of such Joint Patents and with
respect to any such Joint Patent, Epizyme shall have the first right to enforce
such Joint Patent with respect to an infringement by a Third Party infringing
the relevant Joint Patent by making, using or selling a product that competes
with the relevant Product. In the event that BII grants to Epizyme an exclusive
license under Section 13.3.2(f)(10)(B) with respect to any BII Patents or BII
Know-How, BII shall determine whether BII or Epizyme shall have the first right
to (i) Prosecute and Maintain and enforce such BII Patents with respect to an
infringement by a Third Party infringing the relevant BII Patent by making,
using or selling a product that competes with the relevant Product and (ii)
enforce a legal claim with respect to the misappropriation or unauthorized use
of the BII Know-How by a Third Party in the context of making, using or selling
a product that competes with the relevant Product.

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(11)

The Transition Agreement shall make clear that Epizyme shall be responsible for
(i) making any payments (including royalties, milestones and other amounts)
arising out of Epizyme’s exercise of the rights assigned or granted in Section
13.3.2(f)(10) and payable by BII to Third Parties under any Third Party
agreements that may be licensed or assigned to Epizyme by BII by making such
payments directly to BII (in case of a license) or such Third Party (in case of
an assignment) and, in each instance, Epizyme shall make the requisite payments
to BII or the Third Party as applicable and provide the necessary reporting
information to BII in sufficient time to enable BII to comply with its
obligations under such Third Party agreements and (ii) 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.

13.4.Effects of Expiration and Termination. Upon any expiration or termination
of this Agreement with respect to a given Product or in its entirety, (a) all
amounts due or payable to a Party that were accrued, or that arise out of acts
or events occurring prior to the effective date of expiration or termination,
shall remain due and payable and (b) neither Party shall be relieved of any
obligation that accrued prior to the effective date of such expiration or
termination.

13.5.Remedies. Termination of this Agreement (either in its entirety or with
respect to one or more Target Projects) in accordance with the provisions hereof
will not limit remedies that may otherwise be available in law or equity.

13.6.Survival. Termination or expiration of this Agreement (either in its
entirety or with respect to one more Target Projects) for any reason will be
without prejudice to any rights that will have accrued to the benefit of a Party
prior to such termination or expiration. Such termination or expiration will not
relieve a Party from obligations that are expressly indicated to survive the
termination or expiration of this Agreement. Without limiting the foregoing (i)
Sections 4.3.1(b) (Provision of Materials) (with respect to Epizyme continuing
to support BII in matters related to taxes and customs for Materials shipped to
BII prior to expiration or termination of this Agreement), 4.3.3 (Limitations),
4.3.4 (Disclaimer), 5.2.1(b)(iv) (Allocation) (solely with respect to costs
incurred prior to expiration or termination), 5.2.1(d) (Reporting and
Reconciliation Payments; Overruns), 5.2.2(a)(iv) (Allocation) (solely with
respect to amounts incurred prior to expiration or termination), 5.2.2(c)
(Profit Share), 5.4 (Recalls), 6.1.2 (Research Grant), 6.6 (Retention of
Rights), 6.7 (Recordation), 7.4.2 (Royalty Term), 7.10 (Audit; Audit Dispute),
8.1 (Ownership of Intellectual Property), 8.7.1 (Ownership and Prosecution of
Product Marks), 9.2 (Global Safety Database), 11.4 (Disclaimer), 13.3 (Effects
of Termination), 13.4 (Effects of Expiration), 13.5 (Remedies) and 13.6
(Survival) and (ii) ARTICLE 1 (Definitions), ARTICLE 7 (Payments and Records)
(solely with respect to amounts incurred prior to expiration or termination),
ARTICLE 10 (Confidentiality and Non-Disclosure), ARTICLE 12 (Indemnity) and
ARTICLE 14 (Miscellaneous), with respect to each, of this Agreement will survive
the termination or expiration of this Agreement for any reason.

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ARTICLE 14
Miscellaneous

14.1.Force Majeure. Neither Party will be held liable or responsible to the
other Party or be deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any term of this Agreement when
such failure or delay is caused by or results from events beyond the reasonable
control of the non-performing Party, including fires, floods, earthquakes,
hurricanes, embargoes, shortages, epidemics, quarantines, war, acts of war
(whether war be declared or not), terrorist acts, insurrections, riots, civil
commotion, strikes, lockouts, or other labor disturbances (whether involving the
workforce of the non-performing Party or of any other Person), acts of God or
acts, omissions or delays in acting by any governmental authority (except to the
extent such delay results from the breach by the non-performing Party or any of
its Affiliates of any term or condition of this Agreement). The non-performing
Party will notify the other Party of such force majeure within [**] after such
occurrence by giving written notice to the other Party stating the nature of the
event, its anticipated duration, and any action being taken to avoid or minimize
its effect. The suspension of performance will be of no greater scope and no
longer duration than is necessary and the non-performing Party will use
commercially reasonable efforts to remedy its inability to perform.

14.2.Change in Control. Epizyme (or its successor) shall provide BII with
written notice of its Change in Control promptly and no later than [**]
following the closing date of such transaction. Upon a Change in Control of
Epizyme, the following shall occur:

14.2.1U.S. Commercialization Rights. Within [**] following BII’s receipt of
Epizyme’s (or its successor’s) notice of Epizyme’s Change in Control, BII may
elect, upon written notice to Epizyme, to terminate Epizyme’s Development
rights, responsibilities and obligations (other than any Research Activities
with respect to the Joint Compound that are set forth in the Research Plan if
such Change in Control occurs [**] of the Joint Compound) and Commercialization
rights, responsibilities and obligations with respect to the Joint Compound and
Joint Product in the U.S. and vest all such rights, responsibilities and
obligations for the Joint Compound and Joint Product in BII. In such event,
Epizyme (or its successor) shall have no further obligation to, and shall cease
to, perform Development activities (other than any Research Activities to be
performed under the Research Plan provided such Change in Control occurs [**])
and Commercialization activities with respect to such Joint Compound or Joint
Product in the United States, which cessation will occur pursuant to a mutually
agreed to transition plan that will wind-down Epizyme’s performance of (a)
Development activities as soon as reasonably practicable following the effective
date of the opt-out (subject to the requirement that Epizyme continue to perform
its obligations with respect to the Research Activities under the Research Plan
if the Opt-Out Notice is provided prior to [**] as set forth in the first
sentence of this Section 5.2.5 (Epizyme Opt-Out)) and using reasonable efforts
to avoid unnecessary Development disruptions and (b) Commercialization
activities over a period of not more than [**] following Epizyme’s receipt of
BII’s written notice and using reasonable efforts to avoid unnecessary
Commercialization disruptions. For the avoidance of doubt, upon the completion
of the Epizyme activities described in (a)-(b) and reflected in the transition
plan, the license grants under Section 6.1.1 (Grant to Epizyme) shall expire and
terminate. If BII does not provide Epizyme with such written notice within the
aforementioned [**] period, then BII shall be deemed to have waived its right to
terminate Epizyme’s

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Development and Commercialization rights, responsibilities and obligations with
respect to the Joint Compound and Joint Product in the U.S. and to vest all such
rights, responsibilities and obligations for the Joint Compound and Joint
Product in BII pursuant to this Section 14.2.1 (U.S. Commercialization Rights).

14.2.2Financial Ramifications. If BII elects to assume Epizyme’s U.S.
Development and Commercialization rights, responsibilities and obligations with
respect to the Joint Product pursuant to Section 14.2.1 (U.S. Commercialization
Rights), then, if such Change in Control of Epizyme: (a) occurs [**] with
respect to such Joint Product, then the Development Cost share set forth in
Section 5.2.1(b)(iv) (Allocation) and the 50:50 profit and cost share set forth
in Section 5.2.2(a)(iv) (Allocation) shall cease with respect to such Joint
Product and, instead, BII shall pay Epizyme the Opt-Out Royalties pursuant to
Section 5.2.5 (Epizyme Opt-Out) on future Net Sales of such Joint Product in the
U.S.; and (b) occurs [**] with respect to such Joint Product, then the
Development Cost share set forth in Section 5.2.1(b)(iv) (Allocation) and the
50:50 profit and cost share set forth in Section 5.2.2(a)(iv) (Allocation) shall
continue with respect to such Joint Product in the U.S. in accordance with the
terms of this Agreement, with the Parties agreeing that from the end of the
transition plan, all Development Costs and Allowable Expenses shall be fully
incurred by BII since all Development and Commercialization rights shall rest
with BII, and any and all types of Development Costs and Allowable Expenses
incurred by BII shall no longer be subject to a Joint Development Plan and
Budget and a Joint Commercialization Plan and Budget; provided that the
foregoing shall not preclude Epizyme from electing its opt-out option with
respect to such Joint Product pursuant to Section 5.2.5 (Epizyme Opt-Out) at a
future date.

14.3.Export Control. This Agreement is made subject to any restrictions
concerning the export of products or technical Information from the United
States or other countries that may be imposed on the Parties from time to time.
Each Party agrees that it will not export, directly or indirectly, any technical
Information acquired from the other Party under this Agreement or any products
using such technical Information to a location or in a manner that at the time
of export requires an export license or other governmental approval, without
first obtaining the written consent to do so from the appropriate agency or
other governmental entity in accordance with Applicable Law.

14.4.Assignment. Without the prior written consent of the other Party, such
consent not to be unreasonably withheld, conditioned or delayed, neither Party
will sell, transfer, assign, delegate, pledge or otherwise dispose of, whether
voluntarily, involuntarily, by operation of law or otherwise, this Agreement or
any of its rights or duties hereunder; provided that each Party may make such an
assignment without the other Party’s consent to its Affiliate or to a successor,
whether in a merger, sale of stock or sale of substantially all of its assets
that relate to this Agreement. With respect to an assignment to an Affiliate,
the assigning Party will remain responsible for the performance by such
Affiliate of the rights and obligations hereunder. Any attempted assignment or
delegation in violation of this Section 14.4 (Assignment) will be void and of no
effect. All validly assigned and delegated rights and obligations of the Parties
hereunder will be binding upon and inure to the benefit of and be enforceable by
and against the successors and permitted assigns of Epizyme or BII, as the case
may be. The permitted assignee or transferee will assume all obligations of its
assignor or transferor under this Agreement.

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14.5.Severability. If any provision of this Agreement is held to be illegal,
invalid or unenforceable under any present or future law, and if the rights or
obligations of either Party under this Agreement will not be materially and
adversely affected thereby: (a) such provision will be fully severable; (b) this
Agreement will be construed and enforced as if such illegal, invalid or
unenforceable provision had never comprised a part hereof; (c) the remaining
provisions of this Agreement will remain in full force and effect and will not
be affected by the illegal, invalid, or unenforceable provision or by its
severance herefrom; and (d) in lieu of such illegal, invalid or unenforceable
provision, there will be added automatically as a part of this Agreement a
legal, valid and enforceable provision as similar in terms to such illegal,
invalid, or unenforceable provision as may be possible and reasonably acceptable
to the Parties. To the fullest extent permitted by Applicable Law, each Party
hereby waives any provision of law that would render any provision hereof
illegal, invalid, or unenforceable in any respect.

14.6.Governing Law; Service.

14.6.1Governing Law. This Agreement or the performance, enforcement, breach or
termination hereof will be interpreted, governed by and construed 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 Parties agree
to exclude the application to this Agreement of the United Nations Convention on
Contracts for the International Sale of Goods.

14.6.2Service. Each Party further agrees that service of any process, summons,
notice or document by registered mail to its address set forth in Section 14.8.2
(Address for Notices) will be effective service of process for any action, suit,
or proceeding brought against it under this Agreement in any such court.

14.7.Dispute Resolution. Except for disagreements resolved by the procedures set
forth in Sections 2.2.3 (Disagreement Resolution), 7.10 (Audit; Audit Dispute)
or 14.11 (Equitable Relief), if a dispute arises between the Parties in
connection with or relating to this Agreement or any document or instrument
delivered in connection herewith, it will be resolved pursuant to this Section
14.7 (Dispute Resolution).

14.7.1General. Any dispute will first be referred to the Senior Officers of the
Parties, who will confer in good faith on the resolution of the issue. Any final
decision mutually agreed to by the Senior Officers will be conclusive and
binding on the Parties. If the Senior Officers are not able to agree on the
resolution of any such issue within [**] (or such other period of time as
mutually agreed by the Senior Officers) after such issue was first referred to
them, then either Party may, by written notice to the other Party, elect to
initiate an alternative dispute resolution proceeding pursuant to the procedures
set forth in Section 14.7.2 (ADR; Arbitration) for purposes of having the matter
settled.

14.7.2ADR; Arbitration. If the Parties do not finally and fully resolve a
dispute pursuant to Section 14.7.1 (General) and a Party wishes to pursue the
matter further, then each such dispute that is not an Excluded Claim shall be
finally resolved by binding arbitration in accordance with the Rules of
Arbitration of the ICC and judgment on the arbitration award may be entered in
any court having jurisdiction thereof.

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(a)Except as provided below in this Section 14.7.2(a), the arbitration shall be
conducted by a panel of three (3) Persons. Within [**] after initiation of
arbitration, each Party shall select one (1) Person to act as arbitrator and the
two (2) Party-selected arbitrators shall select a third (3rd) arbitrator within
[**] after their appointment. If the dispute involves claims for damages of less
than USD [**] ($[**]), there shall be only one (1) arbitrator, nominated jointly
by the Parties within [**] days of initiation of arbitration. If any arbitrator
is not nominated within these time periods, the ICC Court of Arbitration shall
appoint such arbitrator. The place of arbitration shall be London, United
Kingdom, and all proceedings and communications shall be in English.

(b)Either Party may apply to the arbitrators for interim injunctive relief until
the arbitration award is rendered or the dispute is otherwise resolved. Either
Party also may also, without waiving any remedy under this Agreement, seek from
any court having jurisdiction any injunctive or provisional relief necessary to
protect the rights or property of that Party pending the arbitration award. The
scope of the authority of the arbitrators shall be limited to the strict
application of law. The arbitrators shall have no authority to award punitive or
any other type of damages not measured by a Party’s compensatory damages, except
as permitted by Section 12.4 (No Consequential Damages). Each Party
participating in an arbitration pursuant to the terms of this Agreement shall,
subject to the award of the arbitrators, pay an equal share of the arbitrators’
fees. The arbitrators shall have the power to award recovery of all costs
(including reasonable attorney’s fees, administrative fees, arbitrators’ fees
and court costs) to the prevailing Party.

(c)Neither Party shall be required to give general discovery of documents, but
may be required to produce documents or testimony that are relevant or
considered relevant by the arbitrators to the dispute. It is the objective and
intent of the Parties that any arbitration proceeding be conducted in such a
manner that a decision will be rendered by the arbitrators within [**] after the
third arbitrator is appointed to the panel, and the Parties and the panel
selected in the manner provided above will adopt rules and procedures intended
to implement such objective and intent.

(d)Except to the extent necessary to confirm or vacate an award or as may be
required by Applicable Law (including applicable securities laws or the rules of
any stock exchange on which a Party’s securities may then be listed), neither a
Party nor an arbitrator may disclose the existence, content, or results of
arbitration without the prior written consent of both Parties. In no event shall
arbitration be initiated after the date when commencement of a legal or
equitable proceeding based on the dispute, controversy or claim would be barred
by the applicable New York statute of limitations.

(e)The Parties agree that any payment made pursuant to this Agreement pending
resolution of the dispute shall be refunded or credited if the arbitrators or
court determines that such payments are not due.

(f)As used in this Section, the term “Excluded Claim” shall mean a dispute that
concerns (i) the validity, enforceability, scope or infringement of a Patent,
Trademark or copyright; or (ii) any antitrust, anti-monopoly or competition law
or regulation, whether or not statutory.

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14.7.3Adverse Ruling. Any determination pursuant to this Section 14.7 (Dispute
Resolution) that a Party is in material breach of its material obligations
hereunder will specify a (nonexclusive) set of actions to be taken to cure such
material breach, if feasible.

14.8.Notices.

14.8.1Notice Requirements. Any notice, request, demand, waiver, consent,
approval or other communication permitted or required under this Agreement will
be in writing, will refer specifically to this Agreement and will be deemed
given only if (a) delivered by hand or (b) by internationally recognized
overnight delivery service that maintains records of delivery, addressed to the
Parties at their respective addresses specified in Section 14.8.2 (Address for
Notice) or to such other address as the Party to whom notice is to be given may
have provided to the other Party in accordance with this Section 14.8.1 (Notice
Requirements). Such notice will be deemed to have been given as of the date
delivered by hand or on the second Business Day (at the place of delivery) after
deposit with an internationally recognized overnight delivery service. This
Section 14.8.1 (Notice Requirements) is not intended to govern the day-to-day
business communications necessary between the Parties in performing their
obligations under the terms of this Agreement.

14.8.2Address for Notice.

If to Epizyme, to:

Epizyme, Inc.

400 Technology Square, 4th Floor

Attention: Chief Executive Officer

Email: [**]

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

Ropes & Gray LLP

800 Boylston Street, Prudential Tower

Boston, MA 02199, USA

Attention: Marc Rubenstein

Email: marc.rubenstein@ropesgray.com

If to BII, to:

Boehringer Ingelheim Corporate Center GmbH

Attn: Head of Strategic Transactions & Alliance Management

Binger Strasse 173

55216 Ingelheim am Rhein

Germany

 

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

 

Boehringer Ingelheim Corporate Center GmbH

Attn: Head of Corporate Legal IU

(same address as above)

-97-

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

 

 

14.9.Entire Agreement; Amendments. This Agreement, together with the Schedules
attached hereto, sets forth and constitutes the entire agreement and
understanding between the Parties with respect to the subject matter hereof and
all prior agreements, understandings, promises and representations, whether
written or oral, with respect thereto are superseded hereby. Each Party confirms
that it is not relying on any representations or warranties of the other Party
except as specifically set forth in this Agreement. No amendment, modification,
release, or discharge will be binding upon the Parties unless in writing and
duly executed by authorized representatives of both Parties.

14.10.English Language. This Agreement will be written and executed in, and all
other communications under or in connection with this Agreement will be in, the
English language. Any translation into any other language will not be an
official version thereof, and in the event of any conflict in interpretation
between the English version and such translation, the English version will
control.

14.11.Equitable Relief. Section 14.7 (Dispute Resolution) notwithstanding, each
Party acknowledges and agrees that remedies available at law for a breach or
threatened breach of any of this Agreement may be inadequate and, in recognition
of this fact, each Party agrees that, in addition to any remedies available at
law (including, without limitation, damages), equitable relief in the form of
specific performance, a temporary restraining order, a temporary or permanent
injunction or any other equitable remedy shall be available in the event of a
breach or threatened breach of this Agreement, without the need for the Party
seeking such remedy to post a bond in connection therewith.

14.12.Waiver and Non-Exclusion of Remedies. Any term or condition of this
Agreement may be waived at any time by the Party that is entitled to the benefit
thereof, but no such waiver will be effective unless set forth in a written
instrument duly executed by or on behalf of the Party waiving such term or
condition. The waiver by either Party hereto of any right hereunder or of the
failure to perform or of a breach by the other Party will not be deemed a waiver
of any other right hereunder or of any other breach or failure by such other
Party whether of a similar nature or otherwise. The rights and remedies provided
herein are cumulative and do not exclude any other right or remedy provided by
Applicable Law or otherwise available except as expressly set forth herein.

14.13.No Benefit to Third Parties. Except as set forth ARTICLE 12 (Indemnity),
the covenants and agreements set forth in this Agreement are for the sole
benefit of the Parties hereto and their successors and permitted assigns, and
they will not be construed as conferring any rights on any other Persons.

14.14.Further Assurance. Each Party will duly execute and deliver, or cause to
be duly executed and delivered, such further instruments and do and cause to be
done such further acts and things, including the filing of such assignments,
agreements, documents, and instruments, as may be necessary or as the other
Party may reasonably request in connection with this Agreement or to carry out
more effectively the provisions and purposes hereof, or to better assure and
confirm unto such other Party its rights and remedies under this Agreement.

-98-

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14.15.Relationship of the Parties. It is expressly agreed that BII, on the one
hand, and Epizyme, on the other hand, will be independent contractors and that
the relationship between the Parties will not constitute a partnership, joint
venture, or agency, including for all tax purposes. Neither BII, on the one
hand, nor Epizyme, on the other hand, will have the authority to make any
statements, representations or commitments of any kind, or to take any action,
which will be binding on the other, without the prior written consent of the
other Party to do so. All Persons employed by a Party will be employees of such
Party and not of the other Party and all costs and obligations incurred by
reason of any such employment will be for the account and expense of such Party.

14.16.Counterparts; Execution. This Agreement may be executed in two (2) or more
counterparts, each of which will be deemed an original, but all of which
together will constitute one and the same instrument. This Agreement may be
executed by electronically transmitted signatures and such signatures will be
deemed to bind each Party hereto as if they were original signatures.

14.17.References. Unless otherwise specified, (a) references in this Agreement
to any ARTICLE, Section or Schedule will mean references to such ARTICLE,
Section or Schedule of this Agreement, (b) references in any Section to any
clause are references to such clause of such Section and (c) references to any
agreement, instrument, or other document in this Agreement refer to such
agreement, instrument or other document as originally executed or, if
subsequently amended, replaced, or supplemented from time to time, as so
amended, replaced, or supplemented and in effect at the relevant time of
reference thereto.

14.18.Construction. Except where the context otherwise requires, wherever used,
the singular will include the plural and the plural the singular, the use of any
gender will be applicable to all genders and the word “or” is used in the
inclusive sense (and/or). Whenever this Agreement refers to a number of days,
unless otherwise specified, such number refers to calendar days. The captions of
this Agreement are for convenience of reference only and in no way define,
describe, extend, or limit the scope or intent of this Agreement or the intent
of any provision contained in this Agreement. The term “including,” “include,”
or “includes” as used herein will mean “including, but not limited to,” and will
not limit the generality of any description preceding such term. The language of
this Agreement will be deemed to be the language mutually chosen by the Parties
and no rule of strict construction will be applied against either Party hereto.
Each Party represents that it has been represented by legal counsel in
connection with this Agreement and acknowledges that it has participated in the
drafting hereof. In interpreting and applying the terms and provisions of this
Agreement, the Parties agree that no presumption will apply against the Party
which drafted such terms and provisions.

[SIGNATURE PAGE FOLLOWS]

-99-

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IN WITNESS WHEREOF, the Parties, through their duly authorized representatives,
have entered into this Agreement as of the Effective Date.

 

BOEHRINGER INGELHEIM INTERNATIONAL GMBH

ppa.

By:

 

Dr. Jochen Gann

Name:

 

Dr. Jochen Gann

Title:

 

Head of CDept. Finance

 

 

ppa.

 

By:

 

/s/ Dorothee Schwall-Rudolph

Name:

 

Dorothee Schwall-Rudolph

Title:

 

Head of Corp. Legal IU

 

EPIZYME, INC.

By:

 

/s/ Robert Bazemore Jr.

Name:

 

Robert Bazemore Jr.

Title:

 

President & CEO

 

 

 

-100-

 

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Schedule 1.40

Compound Criteria

[**]Compound Criteria

 

[**]

 

 

-101-

 

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

 

Schedule 1.48

[**] Competing Product Criteria

[**]

 

 

-102-

 

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Schedule 1.81

FTE Rate

During Calendar Year 2019, the FTE Rate for all FTEs shall be set at a flat rate
of [**] U.S. Dollars ($[**]) per FTE.

 

Beginning with Calendar Year 2020 (and for each subsequent Calendar Year) the
FTE Rate for all FTEs shall be increased or decreased by the percentage increase
or decrease, if any, observed in the Consumer Price Index (“CPI”) based on the
‘Annual’ data for Calendar Year 2019 in relation to Calendar Year 2018, where
“Consumer Price Index” means the Consumer Price Index – Urban Wage Earners and
Clerical Workers, US City Average, All Items, 1982-84 = 100, published by the US
Department of Labor, Bureau of Labor Statistics (or its successor equivalent
index) , as further reflected in the relevant ‘Annual’ column of data in the
below table, taken from the referenced index. For each subsequent Calendar Year,
the similar methodology shall be applied to arrive at the appropriate increase
or decrease in the FTE Rate for such Calendar Year.

 

CPI-Urban Wage Earners and Clerical Workers (Current Series)

 

Series Id:

 

CWUR0000SA0

 

 

 

 

 

 

 

 

 

 

 

 

 

Not Seasonally Adjusted

 

 

 

 

 

 

 

 

 

 

 

 

 

Area:

 

U.S. city average

 

 

 

 

 

 

 

 

 

 

 

 

Item:

 

All items

 

 

 

 

 

 

 

 

 

 

 

 

Base Period:

1982-84=100

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Top of Form

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Download:

Bottom of Form

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Year

Jan

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

Dec

Annual

Half1

Half2

2007

197.559

198.544

200.612

202.130

203.661

203.906

203.700

203.199

203.889

204.338

205.891

205.777

202.767

201.069

204.466

2008

206.744

207.254

209.147

210.698

212.788

215.223

216.304

215.247

214.935

212.182

207.296

204.813

211.053

210.309

211.796

2009

205.700

206.708

207.218

207.925

208.774

210.972

210.526

211.156

211.322

211.549

212.003

211.703

209.63

207.883

211.377

2010

212.568

212.544

213.525

213.958

214.124

213.839

213.898

214.205

214.306

214.623

214.750

215.262

213.967

213.426

214.507

2011

216.400

217.535

220.024

221.743

222.954

222.522

222.686

223.326

223.688

223.043

222.813

222.166

221.575

220.196

222.954

2012

223.216

224.317

226.304

227.012

226.600

226.036

225.568

227.056

228.184

227.974

226.595

225.889

226.229

225.581

226.878

2013

226.520

228.677

229.323

228.949

229.399

230.002

230.084

230.590

230.537

229.735

229.138

229.174

229.324

228.812

229.837

2014

230.04

230.871

232.56

232.56

234.216

234.702

234.525

234.030

234.170

233.229

231.551

229.909

232.771

232.639

232.902

2015

228.294

229.421

231.065

231.520

232.908

233.804

233.806

233.366

232.661

232.373

231.721

230.791

231.810

231.167

232.453

2016

231.061

230.972

232.209

233.438

234.436

235.289

234.771

234.904

235.495

235.732

235.215

235.39

234.076

232.901

235.251

2017

236.854

237.477

237.656

238.432

238.609

238.813

238.617

239.448

240.939

240.573

240.666

240.526

239.051

237.974

240.128

 

However, during the Term of this Agreement, in no instance shall the FTE Rate be
adjusted below [**] U.S. Dollars ($[**]) per FTE nor shall it exceed [**] U.S.
Dollars ($[**]) per FTE.

 

 

 

 

 

-103-

 

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

 

Schedule 1.97

Invoice Requirements

Invoices to be sent to:

Boehringer Ingelheim International GmbH
Accounts Payable
HPZ: [**]
Binger Strasse 173
55216 Ingelheim am Rhein
GERMANY

Quote the BI in-house contact person in a corresponding reference field or
anywhere on the invoice/credit note outside of the address field:

Contact: [**]

Invoices to contain the following information:

 

-

Name and address of the providing (contracting) company …..as listed in the
agreement

 

-

Name and address of the recipient (e.g. Boehringer Ingelheim International GmbH)

 

-

Taxpayer Identification No. of the recipient (e.g. Boehringer Ingelheim
International GmbH: DE [**])

 

-

Taxpayer Identification No. of providing party (if applicable)

 

-

Date of invoice

 

-

Invoice Due Date (as reflected in agreement)

 

-

Invoice No.

 

-

Contract No. of invoicing party

-

Boehringer Ingelheim Contract No. [**]

 

-

For milestone payments invoice shall indicate specific Compound or Product, if
applicable (please adapt wording to specific contract)

 

-

Time/period of deliveries or services

 

-

Description of Services

 

-

Amount due and currency

 

-

Reverse Charge Clause (not applicable)

 

-

Electronic Funds Transfer Instructions to include the below information:

 

•

Name and address of the invoicing party’s bank

 

•

Routing Number

 

•

Account Number

 

•

Swift Code

 

•

IBAN Number

 

-

Additional details are required for VAT purposes

The invoice must be in accordance to the actual tax law to the extent known to
the invoicing Party

-104-

 

 

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

 

Schedule 1.156

Research Plan

Overall Objectives

For the [**] Target Project, the overall research objective is to [**] with
respect thereto are outlined below in the Research Plan.

For the [**] Target Project, the overall research objective is [**] are outlined
below in the Research Plan.

The Research Plan outlines the resources and research activities that are
currently expected to be needed in order to successfully achieve the overall
objectives for the [**] Target Project and [**] Target Project, based on the
[**].  Pursuant to Section 3.3 of the Agreement, the Research Plan will be
periodically reviewed and updated by the Parties as necessary pursuant to the
terms of the Agreement and based on the progress and results that are made as
the Target Projects advance.

-105-

 

 

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

 

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of 65 pages were omitted.[**]

 

-106-

 

 

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Schedule 1.164

[**] Competing Product Criteria

[**]

 

-107-

 

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

 

 

Schedule 10.4

Press Release

Boehringer Ingelheim and Epizyme Announce Worldwide Collaboration to Develop
Novel Epigenetic Oncology Therapies

 

Boehringer Ingelheim Expands Biomarker-driven Oncology Programs

 

Alliance Enhances Epizyme’s Leadership in Oncology Epigenetics

 

CAMBRIDGE, Mass. and INGELHEIM, Germany, [Insert Date], 2018 -- Boehringer
Ingelheim and Epizyme, Inc. (Nasdaq: EPZM) today announced a new global
collaboration focused on the research, development and commercialization of
novel small molecule inhibitors directed toward two previously unaddressed
epigenetic targets as potential therapies for people with cancer. Specifically,
these targets are enzymes within the helicase and histone acetyltransferase
(HAT) families that when dysregulated have been linked to the development of
cancers that currently lack therapeutic options.

 

“Boehringer Ingelheim’s collaboration with Epizyme furthers our strategic vision
to profoundly impact the oncology treatment landscape by enabling a new
generation of precision medicines,” said Clive R. Wood, Ph.D., Senior Corporate
Vice President, Discovery Research, Boehringer Ingelheim. “We are excited to
launch this partnership with Epizyme and to work together with them to advance
epigenetic inhibitors that have the potential to transform the lives of patients
and help win the fight against difficult-to-treat cancers.”

 

Epigenetic modification affects how genes are biologically regulated. More than
half of cancers can stem from functional errors in epigenetic modification. In
particular cases, epigenetic dysregulation is associated with alterations in
specific components of gene regulation, which can be used to identify patients
most likely to benefit from the therapy.  What makes both targets compelling is
not only the clear role they play in cancer but that both targets have patient
stratification biomarkers, which will enable a focus on the patients most likely
to benefit from these potential treatments. Epizyme is a leader in the discovery
of the roles of such enzymes and their development as therapy targets. 

 

“This partnership with Boehringer Ingelheim to develop treatments for two novel
epigenetic targets, which have been historically viewed as undruggable, further
validates the promise of epigenetics for oncology and our pioneering leadership
in this field,” said Robert Bazemore, president and chief executive officer of
Epizyme. “By combining our innovative target identification and research
capabilities with Boehringer Ingelheim’s world-class drug development and
commercialization expertise, we are aiming to realize the full potential of
these targets and our platform, while continuing to focus on executing
development of our lead program in multiple ongoing and planned clinical
trials.”  

 

The collaboration has a strategic goal to focus on lung and other solid tumor
cancers in patients with defined mutations, sub-populations that currently lack
precision medicine treatments. Under

-108-

 

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

 

 

the terms of the agreement, Boehringer Ingelheim and Epizyme will jointly
research and develop a helicase program, with both parties sharing U.S.
commercialization responsibilities and Boehringer Ingelheim assuming
responsibility for commercialization outside the U.S. Epizyme and Boehringer
Ingelheim will share research responsibilities for the HAT program, with
Boehringer Ingelheim assuming responsibility for worldwide development and
commercialization.

 

Epizyme will receive an upfront payment of $15 million and an additional $5
million in research funding in 2019. Epizyme is eligible to receive more than
$280 million in additional payments for research, development, regulatory and
commercial milestones. For the helicase program, Epizyme will fund a portion of
the global development costs, retain a share of U.S. profits and receive tiered
royalties on ex-U.S. sales. For the HAT program, Epizyme is eligible to receive
tiered royalties on worldwide sales.

 

About Helicases and HATs

Helicases are ATP-dependent enzymes that act as molecular motors to unwind and
remodel the nucleic acids that compose DNA and RNA. The human genome has a large
helicase gene family of more than 100 members, some of which have been linked to
multiple cancers when dysregulated.

 

The family of HATs includes 18 enzymes that add acetyl groups to proteins
including histones. Acetylation, along with such other modifications as
methylation and phosphorylation, affects how histones interact with DNA. These
changes in the structural support provided to chromosomes in turn influence gene
expression. Changes in histones, including dysregulated acetylation, have been
associated with diseases including multiple cancers.

 

About Boehringer Ingelheim

Improving the health and quality of life of patients is the goal of the
research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing
so is on diseases for which no satisfactory treatment option exists to date. The
company therefore concentrates on developing innovative therapies that can
extend patients’ lives. In animal health, Boehringer Ingelheim stands for
advanced prevention.

 

Family-owned since it was established in 1885, Boehringer Ingelheim is one of
the pharmaceutical industry’s top 20 companies. Some 50,000 employees create
value through innovation daily for the three business areas human
pharmaceuticals, animal health and biopharmaceuticals. In 2017, Boehringer
Ingelheim achieved net sales of nearly 18.1 billion euros. R&D expenditure,
exceeding three billion euros, corresponded to 17.0 per cent of net sales.

 

As a family-owned company, Boehringer Ingelheim plans in generations and focuses
on long-term success, rather than short-term profit. The company therefore aims
at organic growth from its own resources with simultaneous openness to
partnerships and strategic alliances in research. In everything it does,
Boehringer Ingelheim naturally adopts responsibility towards mankind and the
environment.

 

-109-

 

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More information about Boehringer Ingelheim can be found on
www.boehringer-ingelheim.com or in our annual report:
http://annualreport.boehringer-ingelheim.com.

 

About Boehringer Ingelheim in Oncology
Cancer takes away loved ones, time and untapped potential. At Boehringer
Ingelheim we are providing new hope for patients by taking cancer on. We are
collaborating with the oncology community to deliver scientific breakthroughs to
transform the lives of patients. Our primary focus is in lung and
gastrointestinal cancers, with the goal of delivering breakthrough,
first-in-class treatments that can help win the fight against cancer. Our
commitment to innovation has resulted in pioneering treatments for lung cancer
and we are advancing a unique pipeline of cancer cell directed agents, immune
oncology therapies and intelligent combination approaches to help combat many
cancers.

About Epizyme, Inc.
Epizyme, Inc. is a clinical-stage biopharmaceutical company committed to
rewriting treatment for cancer and other serious diseases through novel
epigenetic medicines. Epizyme is broadly developing its lead product candidate,
tazemetostat, a first-in-class EZH2 inhibitor, with studies underway in both
solid tumors and hematological malignancies, as a monotherapy and combination
therapy in relapsed and front-line disease. The company also is developing a
novel G9a program with its next development candidate, EZM8266, which is
targeting sickle cell disease. By focusing on the genetic drivers of disease,
Epizyme's science seeks to match targeted medicines with the patients who need
them. For more information, visit www.epizyme.com.  

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 relating to the company’s ability to resume enrollment in its
tazemetostat trials and the timing of such resumption, and the impact of safety
findings on enrollment of patients in ongoing and future trials of tazemetostat
following the lifting of the partial clinical hold and the resumption of
enrollment; uncertainties inherent in the initiation of future clinical studies
and in the 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; whether results from preclinical studies or earlier
clinical studies will be predictive of the results of future trials; whether
results from clinical studies will warrant meetings with regulatory authorities,
submissions for regulatory approval or review by governmental authorities under
the accelerated approval process; whether Fast Track Designation and Orphan Drug
Designations will provide the benefits for which tazemetostat is eligible;
expectations for regulatory approvals to conduct trials or to market products;
whether the company's cash resources will be sufficient to fund 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; and other factors discussed
in the "Risk Factors" section of the company's most recent Form 10-Q filed with
the SEC and in the company's other filings from

-110-

 

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

 

 

time to time with the SEC. In addition, the forward-looking statements included
in this press release represent the company's views as of the date hereof and
should not be relied upon as representing the company's views as of any date
subsequent to 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.

 

###

 

Contacts

Media:

 

Linda Ruckel

Boehringer Ingelheim

Linda.ruckel@boehringer-ingelheim.com

917-692-0848

 

Erin Graves

Epizyme, Inc.

media@epizyme.com

617-500-0615

 

 

Investors:

 

Monique Allaire

THRUST Strategic Communications

monique@thrustsc.com

617-895-9511

 

 

-111-

 

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Schedule 13.3

SPECIAL Arbitration

Location. Disputes referred to arbitration covered under this Schedule 13.3
shall be finally resolved by arbitration conducted by three (3) arbitrators in
London, United Kingdom in the English language in accordance with the Rules of
Arbitration of the ICC (International Chamber of Commerce). Each Party shall be
entitled to appoint one arbitrator. The Parties shall appoint their respective
arbitrators within [**] after submission for arbitration. The two (2)
arbitrators so appointed shall agree on the appointment of the third arbitrator
from the list of arbitrators maintained by the ICC. If the Parties’ appointed
arbitrators fail to agree, within [**] from the date both Parties’ arbitrators
have been appointed, on the identity of the third arbitrator, then such
arbitrator shall be appointed by the ICC pursuant to its procedures. The ICC
shall be the administrator of the arbitration proceedings.

Submission of Proposals. Within [**] after appointment of the full arbitration
panel, each Party shall provide to the other Party and the arbitration panel its
proposal for the matter to be decided, which shall approximate as closely as
possible the proposals of such Party previously made in the negotiations between
the Parties with respect thereto, together with a brief or other written
memorandum supporting the merits of its proposal. The arbitration panel shall
promptly convene a hearing, at which time each Party shall have one hour to
argue in support of its proposal. Neither Party may call any witnesses in
support of its arguments.

Ruling. The arbitration panel shall, within [**] after such hearing, select one
Party’s proposal, as applicable, and notify the Parties of such selection in
writing. In making their selection, (a) the arbitrators shall not modify the
terms or conditions of either Party’s proposal; (b) the arbitrators shall not
combine provisions from both Party’s proposals; and (c) to the extent
applicable, the arbitrators shall consider the terms and conditions of this
Agreement (and shall always consider the provisions found in Section 13.3.1(a)
or Section 13.3.2(f)(10)(C) of this Agreement), the relative merits of the
proposals, the then current stage of research, Development or Commercialization
of the Compounds or Products, and the written and oral arguments of the Parties.
The arbitrators may proceed to an award notwithstanding the failure of the other
Party to participate in the proceedings. The arbitrators shall issue a written
decision in order to explain the basis of the ruling, unless otherwise agreed by
the Parties.

Fees. Each Party shall bear its own costs in preparing for the arbitration. The
costs of the arbitrators will be equally divided between the Parties.

Finality. Any decision or award of the arbitrators shall be final, conclusive,
and binding on the Parties, and judgment may be entered on any award in any
court of competent jurisdiction.

-112-