Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Double asterisks denote omissions.
Exhibit 10.1

Confidential

License Agreement

This Agreement, dated as of June 10, 2016, is entered into by and between

F. Hoffmann-La Roche Ltd
with an office and place of business at Grenzacherstrasse 124, 4070 Basel,
Switzerland ("Roche Basel")
and
Hoffmann-La Roche Inc.
with an office and place of business at 150 Clove Road, Suite 8, Little Falls,
New Jersey 07424, U.S.A. ("Roche US"; Roche Basel and Roche US together referred
to as "Roche")
on the one hand
and
Eleven Biotherapeutics, Inc.
with an office and place of business at 215 First Street, Suite 400, Cambridge,
Massachusetts 02142, U.S.A. ("Eleven")
on the other hand.

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

Table of Contents
1.
Definitions
1

 
1.1
Affiliate
1

 
1.2
Agreement
1

 
1.3
Agreement Term
2

 
1.4
Alternative Transaction
2

 
1.5
Applicable Law
2

 
1.6
Base Returnable Product
2

 
1.7
Biosimilar Product
2

 
1.8
BLA
2

 
1.9
Business Day
2

 
1.10
Calendar Quarter
3

 
1.11
Calendar Year
3

 
1.12
Carve-Out Transaction
3

 
1.13
Change of Control
3

 
1.14
Change of Control Group
3

 
1.15
Clinical Study
3

 
1.16
Combination Product
3

 
1.17
Commercially Reasonable Efforts
4

 
1.18
Companion Diagnostic
4

 
1.19
Composition of Matter Claim
4

 
1.20
Compound
4

 
1.21
Compulsory Sublicense Compensation
4

 
1.22
Confidential Information
5

 
1.23
Continuation Election Evaluation Process
5

 
1.24
Continuation Election Notice
5

 
1.25
Control
5

 
1.26
Cover
6

 
1.27
Core Compound Patent Rights
6

 
1.28
Early Returnable Product
6

 
1.29
Effective Date
6

 
1.30
Eleven Base Patent Rights
6

 
1.31
Eleven Cell Line Materials
6

 
1.32
Eleven Compounds
6

 
1.33
Eleven Know-How
7

 
1.34
Eleven Patent Rights
7

 
1.35
EU
7

 
1.36
Excluded Eleven Patent Right
7

 
1.37
Exclusivity Agreement
7

 
1.38
Expert
7

 
1.39
Expiration Date
8

 
1.40
Extended Roche GLP Tox Study
8

 
1.41
FDA
8

 
1.42
FDCA
8

- ii -

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1.43
Field
8

 
1.44
Filing
8

 
1.45
First Commercial Sale
8

 
1.46
First Option Period
9

 
1.47
FujiFilm
9

 
1.48
Handle
9

 
1.49
ICD-10
9

 
1.50
IFRS
9

 
1.51
IND
9

 
1.52
IND Clearance
9

 
1.53
IND Clearance Activities
9

 
1.54
Indication
10

 
1.55
Infringe
10

 
1.56
Initiation
10

 
1.57
Inventory
10

 
1.58
Know-How
10

 
1.59
Licensed Compound
10

 
1.60
Licensed Product
10

 
1.61
Major EU Country
11

 
1.62
Modified Returnable Product
11

 
1.63
Net Sales
11

 
1.64
Non-Prosecution Claim
11

 
1.65
Non-Prosecution Patent Right
12

 
1.66
Party
12

 
1.67
Patent Rights
12

 
1.68
Phase I Study
12

 
1.69
Phase II Study
12

 
1.70
Phase III Study
12

 
1.71
Pre-Commercialized Returnable Product
12

 
1.72
Primary Composition of Matter Claim
12

 
1.73
Product
13

 
1.74
Proprietary Manufacturing IP
13

 
1.75
Qualified Person
13

 
1.76
Regulatory Approval
13

 
1.77
Regulatory Authority
13

 
1.78
Required Company Stockholder Vote
13

 
1.79
Responsibility Transfer Date
14

 
1.80
Returnable Product
14

 
1.81
Roche Activated Termination
14

 
1.82
Roche Group
14

 
1.83
Roche Group Third Party
14

 
1.84
Roche Know-How
14

 
1.85
Roche Patent Rights
14

 
1.86
Royalty Term
14

- iii -

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1.87
Sales
14

 
1.88
Secondary Composition of Matter Claim
15

 
1.89
Second Option Period
16

 
1.90
Signature Date
16

 
1.91
Stockholder Voting Proposal
16

 
1.92
Sublicensee
16

 
1.93
Symbiosis
16

 
1.94
Territory
16

 
1.95
Third Party
16

 
1.96
Third Party Eleven IP
16

 
1.97
US
16

 
1.98
US$
16

 
1.99
Valid Claim
16

 
1.100
Additional Definitions
17

2.
Grant of License
18

 
2.1
Grant of Rights
18

 
2.2
License
18

 
2.3
Sublicense
18

 
2.4
Retained Rights
19

3.
Diligence
19

4.
Development
20

 
4.1
Development for IND Clearance
20

 
4.2
Development Other Than IND Clearance Activities
20

5.
Regulatory
20

 
5.1
Responsibility
20

 
5.2
Disclosure Covenant
21

6.
Manufacture and Supply of Product
21

 
6.1
Product Inventory
21

 
6.2
Responsibility and Transfer
21

 
6.3
GMP Quality Agreements and Auditing
22

7.
Commercialization
22

8.
Information Exchange and Reports
22

 
8.1
Alliance Director
22

 
8.2
Updates to Eleven
23

9.
Payment
23

 
9.1
License Fee
23

 
9.2
Event Payments
23

 
9.3
Royalty Payments
24

 
9.4
Buy-out Options
27

 
9.5
Disclosure of Payments
28

10.
Accounting and Reporting
28

 
10.1
Timing of Payments
28

 
10.2
Late Payment
28

 
10.3
Method of Payment
28

- iv -

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10.4
Currency Conversion
28

 
10.5
Reporting
 
11.
Taxes
29

12.
Auditing
29

 
12.1
Eleven Right to Audit
29

 
12.2
Audit Reports
30

 
12.3
Over- or Underpayment
30

13.
Intellectual Property
30

 
13.1
Prosecution of Primary Eleven Patent Rights
30

 
13.2
Prosecution of Select Non-Prosecution Patent Rights
31

 
13.3
Patent Coordination Liaison
31

 
13.4
Infringement
31

 
13.5
Defense
33

 
13.6
Common Interest Disclosures
33

 
13.7
Biosimilar or interchangeable biological products
34

 
13.8
Patent Term Extensions
34

 
13.9
Consent to File Patent Applications
34

14.
Representations and Warranties
34

 
14.1
Eleven Representations and Warranties
34

 
14.2
Roche Representations and Warranties
36

 
14.3
No Other Representations
37

15.
Indemnification
37

16.
Liability
38

 
16.1
Limitation of Liability
38

 
16.2
Coordination
38

17.
Obligation Not to Disclose Confidential Information
38

 
17.1
Non-Use and Non-Disclosure
38

 
17.2
Permitted Disclosure
38

 
17.3
Press Releases
38

 
17.4
Commercial Considerations
39

18.
Agreement Expiration and Termination
40

 
18.1
Commencement and Expiration
40

 
18.2
Termination
41

 
18.3
Consequences of Termination
42

 
18.4
Royalty and Payment Obligations
48

 
18.5
Survival
48

19.
Solicitation
48

20.
Bankruptcy
49

21.
Miscellaneous
49

 
21.1
Governing Law
49

 
21.2
Disputes
49

 
21.3
Jurisdiction; Arbitration
49

 
21.4
Assignment and Change of Control
50

 
21.5
Debarment
51

- v -

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21.6
Independent Contractor
51

 
21.7
Unenforceable Provisions and Severability
51

 
21.8
Waiver
51

 
21.9
Appendices
51

 
21.10
Entire Understanding
52

 
21.11
Amendments
52

 
21.12
Invoices
52

 
21.13
Notice
52

 
21.14
Interpretation
53

- vi -

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License Agreement

WHEREAS, Eleven has discovered proprietary IL-6 antagonist monoclonal
antibodies, including the compound known as EBI-031 (as defined below), and
possesses proprietary intellectual property rights relating thereto; and
WHEREAS, Roche has expertise in the research, development, manufacture and
commercialization of pharmaceutical and diagnostic products, and wishes to
develop and commercialize such IL-6 antagonist monoclonal antibodies; and
WHEREAS, Eleven is willing to grant to Roche rights to use certain of its
intellectual property rights to make, use, offer for sale, sell and import and
export Licensed Compounds and Licensed Products in the Territory for use in the
Field (as such terms are respectively defined below), as contemplated herein.
NOW, THEREFORE, in consideration of the mutual covenants and promises contained
in this Agreement and other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Parties hereto, intending to
be legally bound, do hereby agree as follows:

1.
Definitions

As used in this Agreement, the following terms, whether used in the singular or
plural, shall have the following meanings:

1.1

Affiliate

The term “Affiliate” shall mean any individual, corporation, association or
other business entity that directly or indirectly controls, is controlled by, or
is under common control with the Party or specified entity in question. As used
in this definition of “Affiliate,” the term “control” shall mean the direct or
indirect ownership of more than fifty percent (>50%) of the stock having the
right to vote for directors thereof or the ability to otherwise control the
management of the corporation or other business entity whether through the
ownership of voting securities, by contract, resolution, regulation or
otherwise. Anything to the contrary in this paragraph notwithstanding, neither
Chugai Pharmaceutical Co., Ltd, a Japanese corporation (“Chugai”) or its
subsidiaries (if any) nor Foundation Medicine, Inc., a Delaware corporation
(“FMI”) or its subsidiaries (if any) shall be deemed as Affiliates of Roche
unless Roche provides written notice to Eleven of its desire to include Chugai,
FMI or their respective subsidiaries (as applicable) as Affiliate(s) of Roche.

1.2

Agreement

The term “Agreement” shall mean this document, including any and all appendices
and amendments to it, as may be amended from time to time in accordance with the
provisions of this Agreement.

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

1.3

Agreement Term

The term “Agreement Term” shall mean the period of time commencing on the
Signature Date and ending on the earlier of the Expiration Date or the effective
date of termination of the Agreement if the Agreement is terminated prior to the
Expiration Date as provided in Article 18.

1.4

Alternative Transaction

The term “Alternative Transaction” shall mean any exclusive outbound license of,
exclusive collaboration regarding, or sale, transfer or other disposition, of a
material portion of Eleven’s assets, rights and know-how in Eleven’s IL-6
program, including EBI-031, whether by agreement, equity purchase, asset
purchase, merger, business combination, restructuring or otherwise, it being
understood and agreed that the following shall not constitute an “Alternative
Transaction”: (i) a Carve-Out Transaction, (ii) a financing transaction solely
related to the continued financing of the operations of Eleven or (iii) the
transactions contemplated by this Agreement.

1.5

Applicable Law

The term “Applicable Law” shall mean any law, statute, ordinance, code, rule or
regulation that has been enacted by a government authority (including without
limitation, any Regulatory Authority) and is in force as of the Signature Date
or comes into force during the Agreement Term, in each case to the extent that
the same is applicable to the performance by the Parties of their respective
obligations under this Agreement.

1.6

Base Returnable Product

The term “Base Returnable Product” shall mean, with respect to a given
Returnable Product, the Returnable Product in its then-existing form at the time
of a Roche Activated Termination applicable to such Returnable Product.

1.7

Biosimilar Product

The term “Biosimilar Product” shall mean, with reference to a given Licensed
Product in a country, a Product that (i) is not produced, licensed or owned by
the Roche Group, (ii) is, according to the relevant Regulatory Authority for the
given country or jurisdiction, highly similar with respect to the given Licensed
Product, notwithstanding minor differences in clinically inactive components,
and with no meaningful differences between the Biosimilar Product and the given
Licensed Product in terms of the efficacy, safety, purity and potency of the
product and (iii) is approved through an abbreviated regulatory pathway. For
countries or jurisdictions where no explicit biosimilar regulations exist, a
Biosimilar Product includes any Product that (x) has been deemed to be a
biosimilar to the given Licensed Product by a Regulatory Authority in another
country or jurisdiction or (y) has the same amino acid sequence as the Compound
in such Licensed Product.

1.8

BLA

The term “BLA” shall mean a Biologics License Application, or similar
application for marketing approval, of a Product for use in the Field submitted
to the FDA, or a foreign equivalent of the FDA.

1.9

Business Day

The term “Business Day” shall mean 9.00am to 5.00pm local time on a day other
than a Saturday, Sunday or other day on which commercial banking institutions in
New York, New York are authorized or permitted by law to be closed.

1.10

Calendar Quarter

The term “Calendar Quarter” shall mean each period of three (3) consecutive
calendar months, ending March 31, June 30, September 30, and December 31.

1.11

Calendar Year

The term “Calendar Year” shall mean the period of time beginning on January 1
and ending December 31, except for the first year of the Agreement Term which
shall begin on the Effective Date and end on December 31.

1.12

Carve-Out Transaction

The term “Carve-Out Transaction” means a merger, tender offer, consolidation or
other business combination pursuant to which the overall business or assets of
Eleven is combined with that of a Third-Party in a transaction (i) that, if to
be entered into prior to the Effective Date, will provide for the continued
effectiveness of this Agreement and the rights and obligations of the Parties
and (ii) that specifically contemplates the exclusion of Eleven’s development
and commercialization rights with respect to the IL-6 program, including
EBI-031.

1.13

Change of Control

The term “Change of Control” shall mean, with respect to Eleven: (i) the
acquisition by any Third Party of beneficial ownership of fifty percent (50%) or
more of the then-outstanding common shares or voting power of Eleven, other than
acquisitions by employee benefit plans sponsored or maintained by Eleven; (ii)
the consummation of a business combination involving Eleven, unless, following
such business combination, the stockholders of Eleven immediately prior to such
business combination beneficially own directly or indirectly more than fifty
percent (50%) of the then outstanding common shares or voting power of the
entity resulting from such business combination; or (iii) the sale of all or
substantially all of Eleven’s assets or business to a Third Party.

1.14

Change of Control Group

The term “Change of Control Group” shall mean the person or entity, or group of
related persons or entities, that is the acquirer of, or the successor to,
Eleven in connection with a Change of Control of Eleven, together with
Affiliates of such persons or entities that are not Affiliates of Eleven
immediately prior to the completion of such Change of Control of Eleven.

1.15

Clinical Study

- 2 -

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

The term “Clinical Study” shall mean a Phase I Study, a Phase II Study or Phase
III Study, as applicable.

1.16

Combination Product

The term “Combination Product” shall mean
a)
a single pharmaceutical formulation containing as its active ingredients both

(i)
a Compound and

(ii)
one or more other therapeutically or prophylactically active ingredients that
are not Compounds (each such therapeutically or prophylactically active
ingredients, a “Non-Compound Active Agent”), or

b)
a combination therapy comprised of

(i)
a Compound and

(ii)
one or more other therapeutically or prophylactically active products containing
at least one Non-Compound Active Agent but not containing any Compounds,

priced and sold in a single package containing such multiple products or
packaged separately but sold together for a single price,
in each case, including all dosage forms, formulations, presentations, line
extensions, and package configurations. All references to Product in this
Agreement shall be deemed to include Combination Product; all references to
Licensed Product in this Agreement shall be deemed to include Combination
Products containing a Licensed Product.

1.17

Commercially Reasonable Efforts

The term “Commercially Reasonable Efforts” shall mean such level of efforts
consistent with

(i)
with respect to Eleven, the efforts that a company of comparable size and
resources to and at the same stage of development as Eleven devotes, and

(ii)
with respect to Roche, the efforts that Roche devotes,

at the same stage of development or commercialization (including, as applicable,
to the Handling of Patent Rights), as applicable, for its own internally
developed pharmaceutical products in a similar area with similar market
potential, at a similar stage of their product life taking into account the
existence of other competitive products in the market place or under
development, the proprietary position of the product, the regulatory structure
involved, the anticipated profitability of the product and other relevant
factors. It is understood that such product potential may change from time to
time based upon changing scientific, business and marketing and return on
investment considerations.

However, Roche (and its Affiliates) does not always seek to market its own
products in every country or seek to obtain regulatory approval in every country
or for every potential indication. As a result, except as expressly set forth in
Article 3, the exercise of diligence by Roche is to be determined by judging
Roche’s commercially reasonable efforts, taken as a whole.

1.18

Companion Diagnostic

- 3 -

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

The term “Companion Diagnostic” shall mean any product that is used for
predicting or monitoring the response of a human being to treatment with a
Product (e.g., device, compound, kit, biomarker or service that contains a
component that is used to detect or quantify the presence or amount of an
analyte in body or tissue that affects the pathogens of the disease).

1.19

Composition of Matter Claim

The term "Composition of Matter Claim" shall mean a Primary Composition of
Matter Claim or a Secondary Composition of Matter Claim.

1.20

Compound

The term “Compound” shall mean any IL-6 antagonist anti-IL-6 monoclonal
antibody, either whole or an active fragment thereof, including EBI-031.

1.21

Compulsory Sublicense Compensation

The term “Compulsory Sublicense Compensation” shall mean, for a given Licensed
Product and a given country or region in the Territory, the compensation paid by
a Roche Group Third Party (in such context, a “Compulsory Sublicensee”) to any
member of the Roche Group (other than such Compulsory Sublicensee) under a
sublicense of Eleven Patent Rights granted to the Compulsory Sublicensee by a
member of the Roche Group through the order, decree or grant of a governmental
authority having competent jurisdiction in such country or region, authorizing
such Roche Group Third Party to manufacture, use, sell, offer for sale, import
or export such Licensed Product in such country or region (the “Compulsory
Sublicense”).

1.22

Confidential Information

The term “Confidential Information” shall mean any and all information, data or
know-how (including Know-How), whether technical or non-technical, oral or
written, that is disclosed by one Party or any of its Affiliates (each, a
“Disclosing Party”) to the other Party or any of its Affiliates (each a
“Receiving Party”), including, after the Effective Date, any Eleven NDA
Information and any Eleven MTA Information. Confidential Information shall not
include any information, data or know-how that:
(i)
was generally available to the public at the time of disclosure by the
Disclosing Party to the Receiving Party, or becomes available to the public
after disclosure by the Disclosing Party to the Receiving Party other than
through fault (whether by action or inaction) of the Receiving Party or any of
its Affiliates under circumstances permitting its use or disclosure,

(ii)
can be evidenced by written records to have been already known to the Receiving
Party or any of its Affiliates prior to its receipt from the Disclosing Party,

(iii)
is obtained by the Receiving Party or any of its Affiliates at any time lawfully
from a Third Party under circumstances permitting its use or disclosure,

(iv)
is developed independently by the Receiving Party or any of its Affiliates as
evidenced by written records other than through knowledge of or reference to the
Disclosing Party’s Confidential Information, or

(v)
is approved in writing by the Disclosing Party for release by the Receiving
Party.

The terms of this Agreement shall be considered Confidential Information of the
Parties, with each Party being considered the Disclosing Party and the Receiving
Party with respect thereto.

- 4 -

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

1.23

Continuation Election Evaluation Process

The term “Continuation Election Evaluation Process” shall mean the procedure
described in Section 18.3.2 that may culminate in Eleven providing Roche with a
Continuation Election Notice.

1.24

Continuation Election Notice

The term “Continuation Election Notice” shall mean the notice Eleven provides to
Roche under Section 18.3.2 describing (i) Eleven’s bona fide intentions to
continue ongoing development and commercialization of specified Returnable
Product(s) and (ii) to the extent applicable, Eleven’s preliminary request for
Roche’s continuation of activities during the termination period or transfer of
the data, material and information relating to the Returnable Product(s) in
accordance with Section 18.3.2.

1.25

Control

The term “Control” shall mean (as an adjective or as a verb including
conjugations and variations such as “Controls” “Controlled” or “Controlling”)
(i) with respect to Patent Rights or Know-How, the possession by a Party (or
another specified entity) of the ability to grant a license or sublicense of
such Patent Rights or Know-How without violating the terms of any agreement or
arrangement between such Party (or such other specified entity) and any other
party and (ii) with respect to proprietary materials, the possession by a Party
(or another specified entity) of the ability to supply such proprietary
materials to the other Party (or another specified entity) as provided herein
without violating the terms of any agreement or arrangement between such
supplying Party (or such other specified supplying entity) and any other party.

1.26

Cover

The term “Cover” shall mean (as an adjective or as a verb including conjugations
and variations such as “Covered,” “Coverage” or “Covering”) that the developing,
making, using, offering for sale, promoting, selling, exporting or importing of
a given compound, formulation or product would Infringe a Valid Claim in the
absence of a license under or ownership in the Patent Rights to which such Valid
Claim pertains. The determination of whether a compound, formulation, process or
product is Covered by a particular Valid Claim shall be made on a
country-by-country basis; for clarity, Valid Claims that apply to a given
country may be national for such country or may be regional or international
where and to the extent applicable to such country.

1.27

Core Compound Patent Rights

The term “Core Compound Patent Rights” shall mean the Core Patent Rights, other
than the Patent Right listed in the Appendix 1.30 table headed “IL-6 Antagonist
Formulations and Uses Thereof” and patents and patent applications claiming
priority from such Patent Right and any substitution, extension or supplementary
protection certificate, reissue, reexamination, renewal, divisional,
continuation or continuation-in-part of any of the foregoing.

- 5 -

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

1.28

Early Returnable Product

The term “Early Returnable Product” shall mean a Returnable Product that has not
yet reached an end-of-Phase-2 meeting with the FDA or EMA or the Initiation of
the first Phase III Study by the effective date of the termination.

1.29 Effective Date
The term “Effective Date” shall mean the date that is one (1) Business Day
following the date on which the Stockholder Voting Proposal shall have been
authorized at the Company Meeting, at which a quorum is present, by the Required
Company Stockholder Vote; provided that no governmental entity of competent
jurisdiction shall have enacted, issued, promulgated, enforced or entered any
order, stay, decree, judgment or injunction or statute, rule or regulation which
has the effect of prohibiting the consummation of the transactions contemplated
by this Agreement.

1.30

Eleven Base Patent Rights

The term “Eleven Base Patent Rights” shall mean any and all Patent Rights in the
Territory that
(a)
are Controlled by Eleven on the Signature Date or

(b)
are Controlled by Eleven and claim first priority to an application filed after
the Signature Date and claim an invention conceived or reduced to practice
before the Signature Date by an employee of Eleven or an individual with an
obligation to assign all rights in such invention and related Patent Rights to
Eleven,

excluding Excluded Eleven Patent Rights and Third Party Eleven IP.
Notwithstanding the foregoing, Eleven Base Patent Rights include the Patent
Rights listed or described in Appendix 1.30 (the “Core Patent Rights”).

1.31

Eleven Cell Line Materials

The term “Eleven Cell Line Materials” shall mean the cell lines and cell banks
currently used or held for use by or on behalf of Eleven to manufacture or
produce Licensed Compounds.

1.32

Eleven Compounds

The term “Eleven Compounds” shall mean the monoclonal antibodies designated as
(i)
EBI-031 (“EBI-031”),

(ii)
EBI-028,

(iii)
EBI-029, and

(iv)
EBI-030.

The sequences of the Eleven Compounds are set forth in Appendix 1.32.

1.33

Eleven Know-How

The term “Eleven Know-How” shall mean Know-How, other than Third Party Eleven
IP, that are necessary or reasonably useful for the research, manufacture,
development or commercialization of any Licensed Compound or Licensed Product
that Eleven Controls
(i)
on the Signature Date or

- 6 -

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

(ii)
during the Agreement Term but prior to a Change of Control (however for clarity,
even in the event of a Change of Control, Eleven Know-How includes the Know-How
relating to Licensed Compounds and Licensed Products to be transferred to Roche
in connection with Articles 4, 5 and 6).

1.34

Eleven Patent Rights

The term “Eleven Patent Rights” shall mean
(a)
the Eleven Base Patent Rights and

(b)
to the extent not included in Eleven Base Patent Rights, the Patent Rights that
Eleven Controls on the period commencing the day after the Signature Date and
ending at the end of the Agreement Term; provided, however, that

(i)
if Roche has exercised a Buy-Out Option, such period shall end on the second
(2nd) anniversary of the Expiration Date, and

(ii)
in any event, such period shall end on the occurrence of a Change of Control,

but for such subpart (b), excluding Excluded Eleven Patent Rights and Third
Party Eleven IP.

1.35

EU

The term “EU” shall mean the European Union and all its then-current member
countries, but in any event includes each of the Major EU Countries, whether or
not then a member of the European Union.

1.36

Excluded Eleven Patent Right

The term “Excluded Eleven Patent Right” means a claim in a Patent Right
Controlled by Eleven that claims a Non-Compound Active Agent, alone or in
combination with other molecular entities, none of which can be Compounds. For
clarity, if a claim in a Patent Right Controlled by Eleven lists a molecular
entity that could be a Compound, then such Patent Right is not an Excluded
Eleven Patent Right.

1.37

Exclusivity Agreement

The term “Exclusivity Agreement” means the Exclusivity Agreement by and between
the Parties effective as of March 15, 2016.

1.38

Expert

The term “Expert” shall mean a person with no less than ten (10) years of
pharmaceutical industry experience and expertise having occupied at least one
senior position within a large pharmaceutical company relating to product
commercialization or licensing but excluding any current or former employee or
consultant of either Party, either Party’s Affiliates or a Sublicensee. Such
person shall be fluent in the English language.

1.39

Expiration Date

The term “Expiration Date” shall mean
(a)
the date Roche provides timely written notice of exercise of a Buy-out Option,
or

(b)
if Roche does not provide timely written notice of exercise of a Buy-out Option,
then on the date after the First Commercial Sale of any Licensed Product when
(i) Roche is not conducting any

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Clinical Studies of any Licensed Product under this Agreement and (ii) the
Royalty Term has ended in each country in the Territory for each Licensed
Product having achieved a First Commercial Sale.

1.40

Extended Roche GLP Tox Study

The term “Extended Roche GLP Tox Study” shall mean, in the case where the FDA
requires an FDA-Required GLP Tox Study, a GLP toxicity study conducted by or on
behalf of Roche that is designed such that the last dose is administered to
subjects more than fifteen (15) weeks after the first dose and is either
(a)
an FDA-Required GLP Tox Study or

(b)
a GLP toxicity study that (i) is not required by the FDA for IND Clearance but
still satisfies the FDA’s requirements for IND Clearance and (ii) is not run in
parallel with or after an FDA-Required GLP Tox Study designed such that the last
dose is administered to subjects fifteen (15) or fewer weeks after the
administration of the first dose.

1.41

FDA

The term “FDA” shall mean the Food and Drug Administration of the United States
of America.

1.42

FDCA

The term “FDCA” shall mean the Food, Drug and Cosmetics Act.

1.43

Field

The term “Field” shall mean all prophylactic, therapeutic and diagnostic use in
all indications in humans or animals.

1.44

Filing

The term “Filing” shall mean the acceptance for substantive review of an
application submitted to FDA, as provided in the Public Health Services Act and
applicable regulations, or the equivalent application to the equivalent agency
in any other country or group of countries, the official approval of which is
required before any lawful commercial sale or marketing of a given Licensed
Product.

1.45

First Commercial Sale

The term “First Commercial Sale” shall mean, on a Licensed Product-by-Licensed
Product and country-by-country basis, the first invoiced sale of such a Licensed
Product to a Roche Group Third Party by a member of the Roche Group in such
country following the receipt of any Regulatory Approval required for the sale
of such Licensed Product, or if no such Regulatory Approval is required, the
date of the first invoiced sale of such Licensed Product to a Roche Group Third
Party by a member of the Roche Group in such country.

1.46

First Option Period

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The term “First Option Period” shall mean the period of time commencing on the
day after the Initiation of the first Phase II Study for a Licensed Product and
ending on the day before the Initiation of the first Phase III Study for a
Licensed Product.

1.47

FujiFilm

The term “FujiFilm” or “Fuji” shall mean FujiFilm Diosynth Biotechologies UK
Limited, located at Belasis Avenue, Billingham, TS23 1LH, United Kingdom.

1.48

Handle

The term “Handle” shall mean preparing, filing, prosecuting (including
interference and opposition proceedings) and maintaining (including
interferences, reissue, re-examination, post-grant reviews, inter-parties
reviews, derivation proceedings and opposition proceedings).

1.49

ICD-10

The term “ICD-10” shall mean the Tenth Revision of the International
Classifications of Diseases and Related Health Problems, as may be revised or
amended from time to time, or a successor classification.

1.50

IFRS

The term “IFRS” shall mean International Financial Reporting Standards.

1.51

IND

The term “IND” shall mean, with respect to a Licensed Product, an
investigational new drug application as defined in the FDCA and applicable
regulations promulgated by the FDA, the filing of which is necessary to commence
clinical testing of such Licensed Product in humans.

1.52

IND Clearance

The term “IND Clearance” shall mean the first IND for any Licensed Product going
into effect in accordance with 21 C.F.R. 312.40(b).

1.53

IND Clearance Activities

The term “IND Clearance Activities” shall mean any activities required by the
FDA (if any), after submission of the IND for EBI-031 by Eleven, to achieve IND
Clearance for EBI-031.

IND Clearance Activities to be conducted by or on behalf of Roche (“Roche IND
Clearance Activities”) are:
(a)
new GLP toxicology stud(y)(ies) required by the FDA to achieve IND Clearance for
EBI-031 (each an “FDA-Required GLP Tox Study”),

(b)
IND Clearance Activities that the Parties mutually agree should be conducted by
Roche; and

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(c)
on or after September 16, 2016, any IND Clearance Activities that Roche requests
to either conduct or take over from Eleven.

IND Clearance Activities to be conducted by or on behalf of Eleven (“Eleven IND
Clearance Activities”) are all IND Clearance Activities other than Roche IND
Clearance Activities.

1.54

Indication

The term “Indication” shall mean a disease (i) for which the given Licensed
Product is indicated for treatment (or for which a BLA for such Licensed Product
is filed) and (ii) that is described in the Licensed Product label as required
by the Regulatory Approval granted by the applicable Regulatory Authority (or
which is proposed in the BLA).

To distinguish one Indication from another Indication, the two Indications have
to be (i) listed in two different blocks of the ICD-10 (as a way of example, any
retinopathy under H35 is in a different block from any retinopathy under block
H31, whereas H35.023 and H35.031 belong to the same block) and (ii) developed by
Roche under separate pivotal Clinical Studies.

1.55

Infringe

The term “Infringe” shall mean (a) with respect to a claim in an issued patent,
that such claim would, in the absence of a license under or ownership of such
claim, be infringed by the applicable activity, and (b) with respect to a claim
in a patent application, that such claim would, in the absence of a license
under or ownership of such claim, be infringed by the applicable activity if
such claim were to issue.

1.56

Initiation

The term “Initiation” shall mean, as applicable in this Agreement, the date that
a human is first dosed with the given Licensed Product in a Clinical Study
approved by the respective Regulatory Authority or otherwise permitted under
Applicable Law, or the date that the first animal is dosed with a Licensed
Product containing EBI-031 in an Extended Roche GLP Tox Study.

1.57

Inventory

The term “Inventory” shall mean all existing clinical and non-clinical grade
drug product, active pharmaceutical ingredient, intermediates and raw materials
associated with Licensed Compounds in the Control of Eleven, as well as any
other existing materials (such as reference standards and retention samples),
drug delivery systems and packaging associated with the manufacture or testing
of such Licensed Compounds and Licensed Products containing therein.

1.58

Know-How

The term “Know-How” shall mean data, knowledge and information, including
materials, samples, chemical manufacturing data, toxicological data,
pharmacological data, preclinical data, assays, platforms, formulations,
specifications, quality control testing data, that are necessary or reasonably
useful for the research, manufacture, development or commercialization of
Products.

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1.59

Licensed Compound

The term “Licensed Compound” shall mean
(a)
any Eleven Compound or

(b)
any other Compound that (i) is Covered by a Core Compound Patent Right in the US
or EU or (ii) was Covered by an issued Core Compound Patent Right in the US or
EU that has expired less than ten (10) years from the applicable date.

1.60

Licensed Product

The term “Licensed Product” shall mean a Product containing a Licensed Compound.

1.61

Major EU Country

The term “Major EU Country” shall mean any of the following: France, Germany,
Italy, Spain and the United Kingdom.

1.62

Modified Returnable Product

The term “Modified Returnable Product” shall mean, with respect to a given
Returnable Product, a version of the applicable Base Returnable Product modified
by or on behalf of Eleven or any of its Affiliates, licensees or sublicensees
after the time of the applicable Roche Activated Termination (but before
commercialization of the Returnable Product) in a manner consistent with
customary progression of the development of such Returnable Product.

1.63

Net Sales

The term “Net Sales” shall mean, for a Licensed Product in a particular period,
the amount calculated by subtracting from the Sales of such Licensed Product for
such period described in Section 1.87(i): (i) a lump sum deduction of four
percent (4%) of such Sales in lieu of those deductions that are not accounted
for on a Licensed Product-by-Licensed Product basis (e.g., freight, postage
charges, transportation insurance, packing materials for dispatch of goods,
custom duties); (ii) uncollectible amounts accrued during such period with
respect to such Sales based on a proportional allocation of the total bad debts
accrued during such period and not already taken as a gross-to-net deduction in
accordance with the then currently used IFRS in the calculation of such Sales of
such Licensed Product for such period; (iii) credit card charges (including
processing fees) incurred during such period on such Sales and not already taken
as a gross-to-net deduction in accordance with the then currently used IFRS in
the calculation of Sales of such Licensed Product for such period; and
(iv) government mandated fees and taxes and other government charges accrued
during such period with respect to such Sales not already taken as a
gross-to-net deduction in accordance with the then currently used IFRS in the
calculation of such Sales of such Licensed Product for such period, including,
for example, any fees, taxes or other charges that become due in connection with
any healthcare reform, change in government pricing or discounting schemes, or
other action of a government or regulatory body, but excluding any taxes on net
income of a member of the Roche Group. For clarity, no deductions taken in
calculating Sales under Section 1.87 may be taken a second time in calculating
Net Sales,

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and no deductions under this definition of Net Sales may be taken more than once
in calculating Net Sales for a given Licensed Product for a given period.

1.64

Non-Prosecution Claim

The term “Non-Prosecution Claim” means a claim in a Patent Right Controlled by
Eleven that, (i) in the absence of a license, would not be Infringed by the use
or sale of a Compound; (ii) claims a generic class of compounds, a formulation
of a generic class of compounds, or a method of making or using a generic class
of compounds, which, in the absence of a license, would be Infringed by the use
or sale of a Compound and would be Infringed by the use or sale of a compound
other than a Compound; or (iii) in the absence of a license, would be Infringed
by the use or sale of a Licensed Product and would be Infringed by the use or
sale of a corresponding Compound-Free Product. As used in this definition with
respect to a given Licensed Product, the term “Compound-Free Product” means a
product that includes the same therapeutically or prophylactically active
ingredients as the Licensed Product with the sole exception being the absence of
Licensed Compound(s)). For clarity, the determination of whether a given claim
in a Patent Right is a Non-Prosecution Claim shall be made on a patent claim
basis.

1.65

Non-Prosecution Patent Right

The term “Non-Prosecution Patent Right” means a Patent Right that includes a
Non-Prosecution Claim.

1.66

Party

The term “Party” shall mean Eleven or Roche, as the case may be, and “Parties”
shall mean Eleven and Roche collectively.

1.67

Patent Rights

The term “Patent Rights” shall mean all rights under any patent or patent
application, in any country of the Territory, including any patents issuing on
such patent application, and further including any substitution, extension or
supplementary protection certificate, reissue, reexamination, renewal,
divisional, continuation or continuation-in-part of any of the foregoing.

1.68

Phase I Study

The term “Phase I Study” shall mean a human clinical trial in any country that
would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from
time to time, and the foreign equivalent thereof.

1.69

Phase II Study

The term “Phase II Study” shall mean a human clinical trial that includes
(i)
a control arm (placebo or standard of care),

(ii)
a minimum of one hundred (100) patients per indication (except (x) if the
indication is an orphan indication as determined under Applicable Law, in which
case there shall be no such minimum, or (y) if the clinical trial is intended to
explore multiple indications in the same arm or arms of

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such clinical trial, in which case a minimum of one hundred (100) total
patients, irrespective of indication, shall apply), and
(iii)
a minimum duration of dosing for each patient of five (5) months from the
initial dose until the last dose, regardless of how frequently any such patients
are dosed,

for which the primary endpoints include a determination of dose ranges or a
preliminary determination of efficacy in patients being studied, as described in
21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign
equivalent thereof.

1.70

Phase III Study

The term “Phase III Study” shall mean a human clinical trial that is
prospectively designed to, if successful, demonstrate statistically whether a
product is safe and effective for use in humans in a manner which, if such trial
is successful, would be sufficient, alone or with other Clinical Studies, to
seek to obtain regulatory approval to market such product in patients having the
disease or condition being studied, as described in 21 C.F.R. § 312.21(c)
(FDCA), as amended from time to time, and the foreign equivalent thereof.

1.71

Pre-Commercialized Returnable Product

The term “Pre-Commercialized Returnable Product” shall mean a Returnable Product
that has not achieved First Commercial Sale anywhere in the Territory on the
effective date of termination.

1.72

Primary Composition of Matter Claim

The term "Primary Composition of Matter Claim" shall mean, for a given Licensed
Product in a given country of the Territory, a Valid Claim of an Eleven Patent
Right that (i) claims the composition of matter of a Compound included in such
Licensed Product and (ii) but for the licenses granted in this Agreement would
be Infringed by the use or sale of such Compound as a pharmaceutical agent. For
clarity, Valid Claims of an Eleven Patent Right that claim manufacturing
processes, product-by-process, formulations or delivery devices shall not be
deemed as Primary Composition of Matter Claims, provided that a composition
claim from the Core Compound Patent Rights which includes a term such as
formulation, preparation, pharmaceutical preparation, or similar terms, such as
"a composition of formulation x,...", which without such term would be
considered a composition of matter claim, will be considered a Primary
Composition of Matter Claim.

1.73

Product

The term “Product” shall mean any product containing a Compound as a
pharmaceutically active agent, regardless of their finished forms, delivery
methods, formulations or dosages.

1.74

Proprietary Manufacturing IP

The term “Proprietary Manufacturing IP” shall mean cell lines, growth media,
culture media or technical development/manufacturing know-how that is Controlled
by Roche and in Roche’s good faith judgment contains valuable trade secrets with
broader applicability than solely to the Returnable Products, and Roche Patent
Rights that claim thereof.

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1.75

Qualified Person

The term “Qualified Person” shall mean any person or entity making an
unsolicited inquiry, proposal or offer with respect to an Alternative
Transaction that Eleven’s Board of Directors determines in good faith (after
consultation with outside counsel and its financial advisors) is, or could
reasonably be expected to lead to an Alternative Transaction that is, more
favorable to Eleven or its stockholders than the transactions contemplated by
this Agreement, taking into account all the terms and conditions of such
proposal or offer, and that is reasonably capable of being completed on the
terms proposed, taking into account all financial, regulatory, legal and other
aspects of such proposal or offer.

1.76

Regulatory Approval

The term “Regulatory Approval” shall mean any approvals, registrations or
authorizations by Regulatory Authority, necessary for the sale of a Product in
the Field in a regulatory jurisdiction in the Territory.

1.77

Regulatory Authority

The term “Regulatory Authority” shall mean any national, supranational (e.g.,
the European Commission, the Council of the European Union, the European
Medicines Agency), regional, state or local regulatory agency, department,
bureau, commission, council or other governmental entity, including the FDA, in
each country involved in the granting of Regulatory Approval for the Product.

1.78

Required Company Stockholder Vote

The term “Required Company Stockholder Vote” shall mean the affirmative vote in
favor of the Stockholder Voting Proposal by the holders of at least a majority
of the outstanding shares of Eleven’s common stock, par value $0.001, on the
record date for the meeting of Eleven’s stockholders (the “Company Meeting”) to
consider the Stockholder Voting Proposal.

1.79

Responsibility Transfer Date

The term “Responsibility Transfer Date” shall mean the earlier of
(a)
the date of the IND Clearance for a Licensed Product containing EBI-031 or

(b)
in the case of on-going Roche IND Clearance Activities, the conclusion of Eleven
IND Clearance Activities (with the Parties to work in good faith to agree upon
the appropriate date for conclusion of Eleven IND Clearance Activities).

1.80

Returnable Product

The term “Returnable Product” shall mean a Licensed Product subject to a Roche
Activated Termination that has advanced at least into Initiation of a Phase I
Study by the effective date of such Roche Activated Termination.

1.81

Roche Activated Termination

The term "Roche Activated Termination” shall mean a termination by Eleven for
Roche’s material breach under Section 18.2.1 or for development discontinuation
under Section 18.2.3 (each an

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“Involuntary Termination”) or by Roche without cause under Section 18.2.2 (a
“Voluntary Termination”).

1.82

Roche Group

The term “Roche Group” shall mean collectively Roche, its Affiliates and its
Sublicensees.

1.83

Roche Group Third Party

The term “Roche Group Third Party” shall mean a Third Party other than a member
of the Roche Group.

1.84

Roche Know-How

The term “Roche Know-How” shall mean all Know-How that (i) Roche and Roche’s
Affiliates Control during the Agreement Term and (ii) would be necessary to
develop, manufacture or commercialize a given Base Returnable Product; however
subject to Sections 18.3.4.2(c) and Section 18.3.4.3.

1.85

Roche Patent Rights

The term “Roche Patent Rights” shall mean all Patent Rights that (i) Roche and
Roche’s Affiliates Control during the Agreement Term and (ii) would be necessary
to develop, manufacture, import, offer for sale, use or sell a given Base
Returnable Product; however subject to Section 18.3.4.3. For purposes of
clarity, the Patent Rights identified in Appendix 1.85 (“Excluded Roche Patent
Rights”) are specifically excluded from the Roche Patent Rights.

1.86

Royalty Term

Subject to Section 9.4, the term “Royalty Term” shall mean, on a
country-by-country basis, with respect to a Licensed Product, the period of time
commencing on the date of First Commercial Sale of such Licensed Product in such
country and ending on the later of the date that is (i) ten (10) years after the
date of the First Commercial Sale of such Licensed Product in such country, or
(ii) the expiration of the last to expire Composition of Matter Claim Covering
such Licensed Product or any Compound in such Licensed Product in such country.

1.87

Sales

The term “Sales” shall mean, for a Licensed Product in a particular period, the
sum of (i) and (ii):

(i)
the amount stated in the Roche Holding AG “Sales” line of its externally
published audited consolidated financial statements with respect to such
Licensed Product for such period (excluding sales for resale to any Sublicensees
that are not Affiliates of Roche). This amount reflects the gross invoice price
at which such Licensed Product was sold or otherwise disposed of (other than for
use as clinical supplies or free samples) by Roche and its Affiliates to such
Third Parties (excluding sales to any Sublicensees that are not Affiliates of
Roche) in such period reduced by gross-to-net deductions, if not previously
deducted from such invoiced amount, taken in accordance with the then currently
used IFRS.

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By way of example, the gross-to-net deductions taken in accordance with IFRS as
of the Effective Date include the following:

(a)
credits, reserves or allowances granted for (i) damaged, outdated, returned,
rejected, withdrawn or recalled Licensed Product, (ii) wastage replacement and
short-shipments; (iii) billing errors and (iv) indigent patient and similar
programs (e.g., price capitation);

(b)
governmental price reductions and government mandated rebates;

(c)
chargebacks, including those granted to wholesalers, buying groups and
retailers;

(d)
customer rebates, including cash sales incentives for prompt payment, cash and
volume discounts; and

(e)
taxes, duties and any other governmental charges or levies imposed upon or
measured by the import, export, use, manufacture or sale of a Licensed Product
(excluding income or franchise taxes).

For purposes of clarity, sales by Roche and its Affiliates to any Sublicensee
that is not a Roche Affiliate for resale shall be excluded from clause (i) of
this definition of “Sales”.

(ii)
for Sublicensees that are not Roche Affiliates (and excluding Compulsory
Sublicensees), the sales amounts reported to Roche and its Affiliates in
accordance with the sublicensee contractual terms and their then-currently used
accounting standards. For the purpose of clarity, any such Sublicensee sales as
reported to Roche in accordance with Compulsory Sublicense agreements shall be
excluded from the sales amount.

For clarity, no deductions taken in calculating Sales under this Section 1.87
may be taken a second time in calculating Net Sales, and no deductions under
this definition of Sales may be taken more than once in calculating Net Sales
for a given Licensed Product for a given period.

1.88

Secondary Composition of Matter Claim

The term "Secondary Composition of Matter Claim" shall mean, for a given
Licensed Product in a given country of the Territory, a Valid Claim of an Eleven
Patent Right that (i) claims such Product, (ii) but for the licenses granted in
this Agreement would be Infringed by the use or sale of such Product, and
(iii) is not a Primary Composition of Matter Claim. For clarity, Valid Claims of
an Eleven Patent Right that claim manufacturing processes, product-by-process or
delivery devices shall not be deemed as Secondary Composition of Matter Claims.

1.89

Second Option Period

The term “Second Option Period” shall mean the period of time commencing on the
day after the Initiation of the first Phase III Study for a Licensed Product and
ending on the day before the first Filing of a BLA for a Licensed Product in
either the US or anywhere in the EU.

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1.90

Signature Date

The term “Signature Date” shall mean the date set forth on the cover page to
this Agreement.

1.91

Stockholder Voting Proposal

The term “Stockholder Voting Proposal” shall mean the authorization by Eleven’s
stockholders of the transactions contemplated by this Agreement, including the
grant of the exclusive licenses provided for under, and on the terms and
conditions set forth in, this Agreement.

1.92

Sublicensee

The term “Sublicensee” shall mean an entity to which Roche has licensed rights
(through one or multiple tiers), other than through a Compulsory Sublicense,
pursuant to this Agreement.

1.93

Symbiosis

The term “Symbiosis” shall mean Symbiosis Pharmaceutical Services Ltd., located
at Scio House, Unit 10, Stirling University Innovation Park, Stirling FK9 4NF,
Scotland, United Kingdom.

1.94

Territory

The term “Territory” shall mean the world.

1.95

Third Party

The term “Third Party” shall mean a person or entity other than (i) Eleven or
any of its Affiliates or (ii) Roche or any of its Affiliates.

1.96

Third Party Eleven IP

The term “Third Party Eleven IP” shall mean the Know-How and Patent Rights
licensed to Eleven pursuant to its agreements with Thrombogenics N.V. and
Novozymes Biopharma DK A/S.

1.97

US

The term “US” shall mean the United States of America and its territories and
possessions.

1.98

US$

The term “US$” shall mean US dollars.

1.99

Valid Claim

The term “Valid Claim” shall mean, as applicable, a claim in any (i) unexpired
and issued Patent Right that has not been disclaimed, revoked or held invalid by
a final nonappealable decision of a court of competent jurisdiction or
government agency; or (ii) pending patent application in any country of the

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Territory that (a)  in the situation where such pending patent application is
being Handled by Eleven, Eleven is using Commercially Reasonable Efforts to
Handle such pending patent application and such pending patent application is on
file with the applicable patent office and has shown evidence of reasonable
progression in such applicable patent office to advance to issuance of a patent,
and (b) regardless of whether Eleven or Roche is Handling such pending patent
application, has been on file with the applicable patent office for no more than
seven (7) years from the earliest date to which the patent application claims
its earliest priority, wherein following such date such claim is considered
expired until the date (if any) that such a claim is issued or accepted for
issuance, upon which it is prospectively reinstated as a Valid Claim.

1.100

Additional Definitions

Each of the following definitions is set forth in the Section of this Agreement
indicated below:

Definition
Section
Accounting Period
10.1
Alliance Director
8.1
Bankruptcy Code
20
Breaching Party
18.2.1
Buy-out Notice
9.4
Buy-out Option
9.4
CEEP Start Date
18.3.2
Chugai
1.1
Company Meeting
1.78
Compound-Free Product
1.64
Compulsory Profit Share Percentage
9.3.8
Compulsory Sublicense
1.21
Compulsory Sublicensee
1.21
Core Patent Rights
1.30
Decision Period
13.4
EBI-031
1.32
Eleven Assigned Patent Rights
13.1.2
Eleven IND Clearance Activities
1.53
Eleven MTA Information
21.10
Eleven NDA Information
21.10
Eleven-Originated Transfer Activities
18.3.4.3
Excluded Roche Patent Rights
1.85
Expert Committee
9.3.3
Extended Roche GLP Tox Study Event
9.2
FDA-Required GLP Tox Study
1.53(a)
First Buy-out Option
9.4
FMI
1.1

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Definition
Section
HSR Act
14.1.5
Indemnified Party
15.3
Indemnifying Party
15.3
Initiating Party
13.4
Involuntary Termination
1.81
Minimum Transfer Payment
18.3.4.3
MTA
13.9
NDA
21.10
Non-Breaching Party
18.2.1
Non-Compound Active Agent
1.16
Patent Term Extensions
13.8
Payment Currency
10.3
Peremptory Notice Period
18.2.1
Primary Eleven Patent Rights
13.1.1
Redacted Agreement
17.4
Reference Product Sponsor
13.7
Relative Commercial Value
9.3.3
Representatives
19
Roche IND Clearance Activities
1.53
Roche Indemnitees
15.2
Roche Transfer Activities
18.3.4.3
Samples and PI Information
18.3.4.3
Second Buy-out Option
9.4
Select Non-Prosecution Patent Rights
13.2
Sensitive Information
21.4(c)
Settlement
13.4
SPCs
13.8
Suit Notice
13.4
Voluntary Termination
1.81

2.

Grant of License

2.1

Grant of Rights

Effective on the Signature Date, Eleven hereby agrees to grant Roche the right
to receive the rights and licenses set forth in Section 2.2 as of the Effective
Date.

2.2

License

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Effective on the Effective Date, Eleven hereby grants to Roche an exclusive
(even as to Eleven) right and license, including the right to sublicense, under
Eleven’s interest in the Eleven Patent Rights and Eleven Know-How to make, have
made, use, have used, register, have registered, sell, have sold, offer for
sale, import and export Compounds, Products and Companion Diagnostics in the
Field in the Territory.

The exclusivity of the above license is subject to the right of Eleven to
conduct such pre-clinical development activities, manufacturing and other
obligations (if any) in accordance with this Agreement, including Section 4.1.

2.3

Sublicense

2.3.1

Right to Sublicense to its Affiliates

Roche shall have the right to grant sublicenses to its Affiliates (through
multiple tiers), and to Chugai or FMI if Chugai or FMI is not an Affiliate under
this Agreement, under its rights granted under Section 2.2 without prior
approval of Eleven. If a member of the Roche Group grants such a sublicense,
Roche shall ensure that all of the applicable terms and conditions of this
Agreement shall apply to the Affiliate (or to Chugai or FMI, as applicable) to
the same extent as they apply to Roche for all purposes. Roche assumes full
responsibility for the performance of all obligations and observance of all
terms so imposed on such Affiliate (or on Chugai or FMI, as applicable) and
shall itself account to Eleven for all payments due under this Agreement by
reason of such sublicense.
2.3.2

Right to Sublicense to Third Parties

Roche and its Affiliates shall have the right to grant written sublicenses to
non-Affiliate entities (through multiple tiers) under its rights granted under
Section 2.2 without prior approval of Eleven. Roche shall inform Eleven promptly
after the signature of an agreement under this Section 2.3.2. Each sublicense
shall be consistent in all material respects with the terms and conditions of
the Agreement. Roche shall be responsible for the payment of all amounts due
hereunder, and for all other obligations of its sublicensees under the Agreement
as if such obligations were those of Roche. Eleven shall receive a copy of such
agreement with a Third Party which may be redacted to exclude financial terms
and confidential information of Roche or the Sublicensee. If Roche grants such a
sublicense, Roche shall ensure that all of the applicable terms and conditions
of this Agreement shall apply to the Sublicensee to the same extent as they
apply to Roche for all purposes. Roche assumes full responsibility for the
performance of all obligations and observance of all terms so imposed on such
Sublicensee and shall itself account to Eleven for all payments due under this
Agreement by reason of such sublicense.
2.3.3

Right to Subcontract

Roche shall have the right to subcontract the work performed under this
Agreement without prior approval of Eleven, and Roche is responsible for its
subcontractors’ compliance with this Agreement.

2.4

Retained Rights

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Each Party shall retain all rights under any information, data or know-how
(including Know-How), Patent Rights and other intellectual property rights that
are owned by or licensed to such Party, except for those rights that are
expressly granted to the other Party under this Agreement.

3.

Diligence

Roche and Eleven shall use Commercially Reasonable Efforts to perform their
respective activities contemplated by Articles 4, 5, 6, 7, 8, 13 or 18 of this
Agreement and, subject to Section 13.1.1(a), nothing in Articles 4, 5, 6, 7, 8,
13 or 18 shall imply a higher obligation of diligence imposed on either Party.
Specifically, Roche agrees to use Commercially Reasonable Efforts to pursue
further development and commercialization of Licensed Products in the Field in
the Territory and specifically in the US and anywhere in the EU; and Roche shall
be deemed to have used Commercially Reasonable Efforts with respect to such
obligation if it develops and commercializes at least one Licensed Product in at
least one Indication in the US and anywhere in the EU.

4.

Development

4.1

Development for IND Clearance

If the FDA requires IND Clearance Activities, Eleven shall be responsible for
Eleven IND Clearance Activities at Eleven’s cost as necessary to achieve IND
Clearance, and Roche shall be responsible at Roche’s cost for Roche IND
Clearance Activities as necessary to achieve IND Clearance. Each Party shall
notify the other Party of the results of any IND Clearance Activity it conducts
promptly after its completion, which, in the case of Roche IND Clearance
Activities, such notification shall consist of a status update to Eleven
regarding Roche’s assessment of the progress towards IND Clearance.

As necessary for Roche to continue development of EBI-031, Eleven shall, for
three (3) months after the later of the Effective Date and IND Clearance (except
as otherwise specifically set forth in this Agreement), cooperate with Roche and
disclose and make available to Roche all data and information in Eleven’s
possession and Control regarding EBI-031.

4.2

Development Other Than IND Clearance Activities

Roche, at its sole cost and discretion (but subject to Article 3), shall be
responsible for all development activities of Licensed Products that are not IND
Clearance Activities, except that Eleven shall be responsible at its sole cost
for any tissue cross-reactivity studies of EBI-031 that Eleven initiates before
IND Clearance if such studies are not IND Clearance Activities.

5.

Regulatory

5.1

Responsibility

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Eleven shall be responsible at its own expense, in consultation with Roche
(which consultation shall not in any way be permitted to adversely affect or
delay the achievement of IND Clearance), for all regulatory affairs relating to
the EBI-031 Product prior to the Responsibility Transfer Date. Promptly after
the Responsibility Transfer Date, Eleven shall transfer sponsorship of such IND
to the Roche Affiliate designated by Roche, and the Parties will cooperate to
draft and execute the necessary documents required to effect such transfer. If
the IND for EBI-031 is transferred to Roche prior to achievement of IND
Clearance, Eleven will provide to Roche such assistance as is reasonably
required by Roche to achieve IND Clearance.

After the Responsibility Transfer Date, Eleven shall promptly transfer (or cause
to be transferred) to Roche or Roche’s designee all preclinical and regulatory
documentation in Eleven’s possession and Control regarding the Licensed Product
containing EBI-031, to allow Roche to continue development of Products.

Roche shall thereafter be solely responsible at its own expense for all
regulatory affairs related to Licensed Products in the Territory, including the
preparation and filing of applications for Regulatory Approval, as well as any
or all governmental approvals required to develop, have developed, make, have
made, use, have used, manufacture, have manufactured, import, have imported,
sell and have sold Licensed Products. Roche shall be responsible for pursuing,
compiling and submitting all regulatory filing documentation, and for
interacting with regulatory agencies, for all Licensed Products in all countries
in the Territory. Roche or its Affiliates shall own and file in their sole
discretion (but subject to Article 3) all regulatory filings and Regulatory
Approvals for all Licensed Products in all countries of the Territory.

5.2

Disclosure Covenant

Eleven will promptly disclose to Roche, to the extent not already provided, the
results of all preclinical testing of any Licensed Product in Eleven’s
possession and Control as exists on the later of the Effective Date or the date
of IND Clearance. Eleven will promptly disclose to Roche during the Agreement
Term all information in Eleven’s possession and Control concerning side effects,
injury, toxicity or sensitivity reaction and incidents or severity thereof in
humans with respect to any Licensed Product.

6.

Manufacture and Supply of Product

6.1

Product Inventory

Appendix 6.1 is a complete list of the Inventory (other than intermediates, raw
materials and in-process research material) and Eleven Cell Line Materials under
the Control of Eleven as of the Signature Date.

6.2

Responsibility and Transfer

Eleven shall maintain in full force and effect the CMO agreements with Third
Parties listed on Appendix 6.2 for such time as Roche reasonably requires to
transition, but in no event shall Eleven be required to maintain such agreements
for longer than fifteen (15) months after the Effective Date. In particular,
Eleven shall, at Roche’s expense, ensure during such period (i) the
then-existing Inventory

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and Eleven Cell Line Materials are stored as on the Effective Date unless Roche
provides a written notice requesting otherwise and (ii) the continuation of
on-going testing of EBI-031 and Licensed Product containing EBI-031 under such
agreements.

Eleven shall maintain responsibility for payment under Third Party CMO
agreements for Eleven IND Clearance Activities. Roche (or Roche’s designated
Affiliate) shall assume responsibility for payment under such Third Party CMO
agreements for (i) Roche IND Clearance Activities, (ii) after the Responsibility
Transfer Date, such services as Eleven is required to maintain under this
Agreement (unless waived in writing by Roche), and (iii) such additional
services as Roche requests. At such time as Roche assumes responsibility for
payment, Roche (or Roche’s designated Affiliate) shall have authority for
directing the activities of the applicable CMOs in Eleven’s stead (or through
Eleven, as applicable) in accordance with the applicable CMO agreement, and
Eleven shall cooperate with Roche to ensure transfer of such authority with the
applicable CMOs.

Eleven shall maintain responsibility for the existing inventory of EBI-031 and
Licensed Product containing EBI-031 up to the Responsibility Transfer Date;
however if so requested by Roche, all or a portion of the Inventory and Eleven
Cell Line Materials may be transferred prior to the Responsibility Transfer Date
(with Eleven having the right to retain such Inventory and Eleven Cell Line
Materials needed for Eleven to meet its Eleven IND Clearance Activities under
Section 4.1). After the Responsibility Transfer Date (but for no longer than
fifteen (15) months after the Effective Date), Eleven shall, via the Third Party
CMO agreements (as previously described) under the direction of Roche in
Eleven’s stead or through Eleven, as applicable, maintain the remaining
then-existing Inventory and Eleven Cell Line Materials until such time as
(a) Roche requests and Eleven transfers (or causes to be transferred) such
Inventory and Eleven Cell Line Materials to Roche or Roche’s designee, or
(b) Roche or its Affiliate(s) enters into agreements with the applicable CMOs,
or such agreements are assigned to Roche or its Affiliate, so that Roche may,
directly or through its Affiliates, through such CMOs or other Third Parties,
maintain such Inventory and Eleven Cell Line Materials. For clarity, the
maintenance by Eleven of the Inventory and Eleven Cell Line Materials under the
CMO agreements after the Responsibility Transfer Date shall be paid for by
Roche, however such transfer of the Inventory and Eleven Cell Line Materials to
Roche or Roche’s designee shall be at Eleven’s expense. Once Roche or its
Affiliate(s) has in place agreements with the applicable CMOs (or such
agreements are assigned to Roche or its Affiliate) or Eleven has transferred (or
caused to be transferred) the Inventory and Eleven Cell Line Materials to Roche
or Roche’s designee in accordance with this Section, but in any event no later
than fifteen (15) months after the Effective Date, Eleven shall be free to
terminate such Eleven CMO agreements.

In addition, at Roche’s reasonable request and expense, Eleven shall, within
three (3) months after the later of the Effective Date or the Responsibility
Transfer Date, support the transfer of such manufacturing activities and related
know-how in Eleven’s possession and Control to Roche or Roche’s designee,
including making available to answer Roche questions Eleven representative(s)
with historical knowledge of such CMO activities and contracts.

Roche or Roche’s designee shall in all other events be responsible at its own
expense for the manufacture and supply of clinical and commercial supplies of
the Product.

6.3

GMP Quality Agreements and Auditing

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Upon Roche’s request, the Parties shall execute a separate GMP quality agreement
as Roche deems necessary according to US GMP requirements for the sole purpose
of allowing Roche to verify Eleven’s ability to perform lot disposition
according to US GMP requirements and verifying where applicable that current
quality agreements in place with CMOs are acceptable for the existing GMP
Inventory and GMP Eleven Cell Line Materials.

To the extent it has not done so, and where necessary according to US GMP
requirements, Eleven shall
(a)
promptly enter into a GMP quality agreement with Eleven’s CMOs (including
Eurofins Lancaster Laboratories, Inc.), and

(b)
in good faith facilitate a joint GMP audit of such CMOs by Eleven with Roche, in
each case at Roche’s expense.

7.

Commercialization

Roche, at its own expense, shall have sole responsibility and, as between the
Parties, but subject to Article 3, decision making authority for the marketing,
promotion, sale and distribution of Products in the Territory.

8.

Information Exchange and Reports

8.1

Alliance Director

Each Party shall appoint one person to be its point of contact with
responsibility for facilitating communication and collaboration between the
Parties (each, an “Alliance Director”). The Alliance Directors shall attempt to
facilitate resolution of potential and pending issues and potential disputes.
Each Party may change its Alliance Director on written or email notice to the
other Party.

8.2

Updates to Eleven

Prior to the first Licensed Product to achieve First Commercial Sale, Roche
shall provide Eleven with an annual summary report of the Roche Group’s
development activities with respect to Licensed Products. In addition, prior to
the first BLA Filing, the Roche Alliance Director shall be available upon
Eleven’s request to answer questions about the status of the Roche Group’s
development activities once per each Calendar Quarter (except for such Calendar
Quarter that Roche provides Eleven with the annual summary report).

9.

Payment

9.1

License Fee

Within thirty (30) days after the Effective Date and receipt of an invoice from
Eleven, Roche shall pay to Eleven Seven Million Five Hundred Thousand US Dollars
(US$ 7,500,000).

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9.2

Event Payments

Roche shall pay up to a total of Two Hundred Sixty-Two Million Five Hundred
Thousand US Dollars (US$ 262,500,000) in relation to the achievements of events
with respect to Licensed Products. The event payments under this Section 9.2
shall be paid by Roche according to the following schedule of development
events.

Event
US Dollars (in millions)
IND Clearance-Related Events
(a) IND Clearance (if IND Clearance is achieved on or before September 15, 2016)
$22.5*
(b) IND Clearance (if IND Clearance is achieved after September 15, 2016 and no
Extended Roche GLP Tox Study)
$20*
(c) Initiation of the first Extended Roche GLP Tox Study (the “Extended Roche
GLP Tox Study Event”)
$5*
(d) IND Clearance (if IND Clearance is achieved after September 15, 2016 and
subsequent to completion of an Extended Roche GLP Tox Study)
$15
Initiation of the first Phase II Study
$20
Initiation of the first Phase III Study
$30
BLA Filing in US
$25
BLA Filing anywhere in the EU**
$15
BLA Filing in Japan
$10
First Commercial Sale in US
$40
First Commercial Sale anywhere in the EU**
$25
First Commercial Sale in Japan
$10
BLA Filing for a second Indication in US
$10
BLA Filing for a second Indication anywhere in the EU**
$5
Regulatory Approval in a second Indication in US
$30
Regulatory Approval in a second Indication anywhere in the EU**
$20

Except as otherwise set forth in this Section 9.2, each event payment shall be
paid only once, the first time the first Licensed Product reaches the applicable
triggering event, regardless of the number of times such events are reached and
by how many Licensed Products. To the extent that any of the above triggering
events contemplate precursor events (e.g., the first Phase III Study for a
Licensed Product commonly follows the first Phase II Study for a Licensed
Product), such triggering event, if achieved, shall result in the payment of the
contemplated precursor milestone payment if such payment has not yet otherwise
been triggered.

For any events first achieved by a Licensed Product containing a Licensed
Compound other than EBI-031, Eleven shall receive fifty percent (50%) of the
amounts in the above table with no further amount owed for any such event;
provided, however, that if the event first achieved with such Licensed

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Compound other than EBI-031 involves a non-ophthalmology indication and the
event subsequently-achieved with a Licensed Product containing EBI-031 involves
an ophthalmology indication, then Eleven shall receive the remaining fifty
percent (50%) of such amounts.

* minus the Exclusivity Fee Payment (as such term is defined in the Exclusivity
Agreement) previously paid by Roche. For clarity, only one of the IND Clearance
payments in clause (a), (b) or (d) above shall be payable under this Agreement,
and the Extended Roche GLP Tox Study Event in clause (c) above shall only apply
in conjunction with the IND Clearance event payment associated therewith in
clause (d) above.

** Event payments shall be reduced by fifty percent (50%) in the event there is
no Eleven Patent Right issued anywhere in the EU containing a Primary
Composition of Matter Claim Covering the Licensed Compound in such Licensed
Product or the Licensed Product at the time the event is achieved.

The applicable IND Clearance event payment shall be made within thirty (30) days
after occurrence of the IND Clearance (of which Roche shall timely notify Eleven
if the IND Clearance occurs after the Responsibility Transfer Date) and receipt
of an invoice from Eleven. For all other event payments, upon achieving events,
Roche shall timely notify Eleven and event payments shall be paid by Roche to
Eleven within thirty (30) days from occurrence of the applicable event and
receipt of an invoice from Eleven.

9.3

Royalty Payments

9.3.1

Royalty Term

Roche shall pay to Eleven royalties on Net Sales of Licensed Products during the
applicable Royalty Terms. Thereafter, the licenses granted to Roche shall be
fully paid up, irrevocable and royalty-free.
9.3.2

Royalty Rates

The following royalty rates shall apply to the respective tiers of aggregate
Calendar Year Net Sales of a Licensed Product in the Territory, on an
incremental basis, as follows:

Tier of Calendar Year
Net Sales in billion US$
Percent (%) of Net Sales of Licensed Products containing EBI-031*
0 – 1
7.5%
> 1 – 2
9%
> 2 – 4
11%
> 4
15%

For example, if Net Sales of a Licensed Product containing EBI-031, for a given
Calendar Year, are US$ 3.5 billion, then royalties owed to Eleven on such Net
Sales of such Licensed Product for that Calendar Year shall equal US$ three
hundred thirty million (US$ 330,000,000) calculated as follows:

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[(0.075*1 billion)+(0.09*1 billion)+(0.11*1.5 billion)] = US$330,000,000 royalty
payment

* Royalty rates on Licensed Products that do not contain EBI-031 shall be at
fifty percent (50%) of the EBI‑031 royalty rates.

For the purpose of calculating royalties of a Licensed Product, Calendar Year
Net Sales and the royalty rates shall be subject to the following adjustments,
as applicable:
9.3.3

Combination Product

If Roche or its Affiliates intend to sell a Combination Product, then the
Parties shall meet approximately one (1) year prior to the anticipated First
Commercial Sale of such Combination Product in the Territory to negotiate in
good faith and agree to an appropriate adjustment to Net Sales to reflect the
relative commercial value contributed by the components of the Combination
Product (the “Relative Commercial Value”). If, after such good faith
negotiations not to exceed ninety (90) days, the Parties cannot agree to an
appropriate adjustment, the dispute shall be initially referred to the executive
officers of the Parties in accordance with Section 21.2.

If the Parties are unable to agree on the Relative Commercial Value, then Roche
will select one (1) individual who would qualify as an Expert, Eleven will
select (1) individual who would qualify as an Expert, and those two (2)
individuals shall select one (1) individual who would qualify as an Expert and
who shall be chairman of a committee of the three Experts (the “Expert
Committee”), each with a single vote. The Expert Committee will promptly hold a
meeting to review the issue under review, at which it will consider memoranda
submitted by each Party at least fifteen (15) days before the meeting, as well
as reasonable presentations that each Party may present at the meeting. The
determination of the Expert Committee as to the issue under review will be
binding on both Parties. The Parties will share equally in the costs of the
Expert Committee. Unless otherwise agreed to by the Parties, the Expert
Committee may not decide on issues outside the scope mandated under terms of
this Section 9.3.3.

For any Combination Product that includes the active ingredient ranibizumab as
its only other active ingredient, the Relative Commercial Value of the Licensed
Compound may not be less than fifty percent (50%); however if either Eleven or
Roche reasonably believes the Licensed Compound in a Combination Product that
includes ranibizumab as its only other active ingredient has a Relative
Commercial Value of more than fifty percent (50%) in such Combination Product,
then the procedure in this Section 9.3.3 shall apply.
9.3.4

No Primary Composition of Matter Claim

With respect to a given Licensed Product, if in a given country within the
Territory there is no Primary Composition of Matter Claim Covering such Licensed
Product in such country, then
(a)
If, after the ten year anniversary of the First Commercial Sale of such Licensed
Product in such country, there is a Secondary Composition of Matter Claim
Covering such Licensed Product in such country and a Biosimilar Product has
entered the market in such country then no royalty payments shall be due to
Eleven for such Licensed Product in such country; otherwise

(b)
the royalty payments due to Eleven for such Licensed Product in such country
shall be reduced by fifty percent (50%).

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9.3.5

Biosimilar Product

(a)
If a Product that is a Biosimilar Product to a given Licensed Product enters the
market in a given country prior to the end of the Royalty Term and Net Sales of
such Licensed Product in such country subsequently decrease for two consecutive
Calendar Quarters by more than twenty-five percent (25%) of the level of the Net
Sales of such Licensed Product in such country achieved in the Calendar Year
immediately prior to such entry divided by four, then the royalty rate owed to
Eleven for such Licensed Product shall be reduced by fifty percent (50%) in such
country.

(b)
If subsequent to such a Biosimilar Product entry, the Net Sales of such Licensed
Product in such country decrease by more than fifty percent (50%) of the level
of the Net Sales of such Licensed Product in such country achieved in the
Calendar Year immediately prior to such entry divided by four, then the royalty
rate owed to Eleven in such country for such Licensed Product shall be reduced
by seventy-five percent (75%) in such country.

9.3.6

Third Party Payments

Eleven shall be responsible for satisfying the obligations of all existing
licenses entered into by Eleven prior to the Effective Date. The Roche Group
shall be responsible for and pay or have paid the entire consideration owed to
any Roche Group Third Party in relation to Roche Group Third Party intellectual
property rights the Roche Group secures after the Effective Date.
(a)
The Roche Group shall not have the right to deduct any amounts paid by the Roche
Group for any Patent Right that claims (i) any pharmaceutically-active compound
other than a Licensed Compound, (ii) any use claims (except those claiming one
or more approved Indications for the Licensed Product in the given country) or
(iii) any manufacturing claims.

(b)
For all other Patent Rights that the Roche Group otherwise would have Infringed
by selling the relevant Licensed Product in the relevant country, the Roche
Group shall have the right to deduct from royalties otherwise due and payable by
the Roche Group to Eleven for such Licensed Product in such country under the
Agreement (i) a maximum of fifty percent (50%) of the royalties actually paid by
the Roche Group to a Roche Group Third Party with respect to such arrangement
except for Patent Rights that claim any delivery device and (i) a maximum of
twenty-five percent (25%) of the royalties actually paid by the Roche Group to a
Roche Group Third Party with respect to such arrangement for Patent Rights that
claim any delivery device. Roche may not otherwise deduct the amounts paid to
any such Roche Group Third Party, including any amounts for the development of
any Licensed Product.

9.3.7

Maximum Deductions

In no event shall the reductions resulting from Sections 9.3.4(b), 9.3.5 or
9.3.6, in the aggregate, reduce the royalty payments to Eleven for any Licensed
Product below fifty percent (50%) of the payments that would otherwise be due
for such Licensed Product pursuant to Section 9.3.2 and 9.3.3, or, if
Section 9.3.5(b) applies, below twenty-five percent (25%) of the payments that
would be otherwise due for such Licensed Product pursuant to Section 9.3.2 and
9.3.3.
9.3.8

Apportionment of Compulsory Sublicensee Consideration

Compulsory Sublicense Compensation received by a member of the Roche Group from
a Compulsory Sublicensee during the Royalty Term shall be shared with Eleven on
an equivalent profit share

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percentage (the “Compulsory Profit Share Percentage”) calculated for the
respective Calendar Year as follows:

1.5      x
(royalties payable to Eleven for the Licensed Product in the Territory)
(Net Sales related to the royalties payable for the Licensed Product in the
Territory)

At the end of the Calendar Year, Roche shall pay to Eleven the Compulsory
Sublicense Compensation under a given country or region of the Territory
multiplied by the Compulsory Profit Share Percentage. The first time the Roche
Group receives Compulsory Sublicense Compensation with respect to a given
country and Licensed Product, Roche shall provide in writing (to the extent
allowed by Applicable Law) the (i) name of the Licensed Product, country and
Compulsory Sublicensee to which such Compulsory Sublicense applies and (ii) the
reason for the relevant Compulsory Sublicense. For clarity, any sales or
payments by Compulsory Sublicensees under a Compulsory Sublicense shall not be
considered as Net Sales and shall not give rise to any royalty payment under
Section 9.3.2 of this Agreement.

9.4

Buy-out Options

Roche shall have the right by providing written notice (the “Buy-out Notice”)
during either the First Option Period (the “First Buy-out Option”) or the Second
Option Period (the “Second Buy-out Option”), to elect to make a one-time payment
to Eleven to buy-out Roche’s remaining payment obligations under the Agreement
with respect to events that had not yet been achieved under Section 9.2 and
Sales that had not yet been made under Section 9.3 (the First Buy-out Option and
the Second Buy-out Option each being a “Buy-out Option”). If Roche elects to
make such payment by providing a timely Buy-out Notice and thereafter making the
associated payment described in this Section, Roche’s exclusive license grant
pursuant to Section 2.2 shall become perpetual, irrevocable and fully paid-up.

If Roche elects to make the First Buy-out Option, Roche shall pay Eleven a
one-time payment of One Hundred Thirty-Five Million US Dollars (US$ 135,000,000)
within thirty (30) days after providing such timely Buy-out Notice to Eleven and
receipt by Roche of an invoice in such amount, after which Roche shall have no
further payment (under Sections 9.2 and 9.3) or diligence obligations to Eleven
under the Agreement (including, for clarity, any milestone payments on events
that occur after delivery of the Buy-out Notice, but not prior to delivery of
the Buy-out Notice).

If Roche elects to make the Second Buy-out Option, Roche shall pay Eleven a
one-time payment of
(i)
Two Hundred Sixty-Five Million US Dollars (US$ 265,000,000) in the event a
Patent Right containing a Primary Composition of Matter Claim Covering any
Licensed Compound or Licensed Product has issued anywhere in the EU, or

(ii)
Two Hundred Twenty Million US Dollars (US$ 220,000,000) in the event no Patent
Right containing a Primary Composition of Matter Claim Covering any Licensed
Compound or Licensed Product has issued anywhere in the EU,

within thirty (30) days after providing such timely Buy-out Notice to Eleven and
receipt by Roche of an invoice in such amount, after which Roche shall have no
further payment (under Sections 9.2 and 9.3) or diligence obligations to Eleven
under the Agreement (including, for clarity, any milestone

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payments on events, or royalties on Sales, that occur after delivery of the
Buy-out Notice, but not prior to delivery of the Buy-out Notice).

If Roche does not elect to make a Buy-out Option, all remaining payment
obligations pursuant to Sections 9.2 and 9.3 shall continue.

9.5

Disclosure of Payments

Each Party acknowledges that the other Party may be obligated to disclose this
financial arrangement, including all fees, payments and transfers of value, as
may be advisable or required under Applicable Law, including the US Sunshine
Act.

10.

Accounting and Reporting

10.1

Timing of Payments

Roche shall calculate royalties on Net Sales quarterly as of March 31, June 30,
September 30 and December 31 (each being the last day of an "Accounting Period”)
and shall pay royalties on Net Sales within ninety (90) days after the end of
each Accounting Period in which such Net Sales occur.

10.2

Late Payment

Any payment 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 two (2) percentage points above the average one-month Euro Interbank Offered
Rate (EURIBOR), as reported by Reuters from time to time, calculated on the
number of days such payment is overdue.

10.3

Method of Payment

Royalties on Net Sales and all other amounts payable by Roche hereunder shall be
paid by Roche in US Dollars (the “Payment Currency”) from a US bank account in
immediately available funds to account(s) designated by Eleven.

10.4

Currency Conversion

When calculating the Sales of any Licensed Product that occur in currencies
other than the Payment Currency, Roche shall convert the amount of such sales
into Swiss Francs and then into the Payment Currency using Roche’s then-current
internal foreign currency translation method actually used on a consistent basis
in preparing its audited financial statements (at the Effective Date, YTD
average rate as reported by Reuters).

10.5

Reporting

With each payment Roche shall provide Eleven in writing for the relevant
Calendar Quarter on a Licensed Product-by-Licensed Product basis the following
information:

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(a)
Sales in Swiss Francs;

(b)
Net Sales in Swiss Francs;

(c)
adjustments made pursuant to Section 9.3.3;

(d)
Net Sales in Swiss Francs after adjustments made pursuant to Section 9.3.3 in
Swiss Francs;

(e)
exchange rate used for the conversion of Net Sales from Swiss Francs to the
Payment Currency pursuant to Section 10.4;

(f)
Net Sales after adjustments made pursuant to Section 9.3.3 in the Payment
Currency;

(g)
royalty rate pursuant to Section 9.3.2;

(h)
adjustments under Sections 9.3.4 - 9.3.7; and

(i)
total royalty payable in the Payment Currency after adjustments made pursuant to
Sections 9.3.4 - 9.3.7.

11.

Taxes

Eleven shall pay all sales, turnover, income, revenue, value added, and other
taxes levied on account of any payments accruing or made to Eleven under this
Agreement, excluding any of the foregoing due on the net income of a member of
the Roche Group.

If Applicable Law of any country requires withholding of taxes of any type,
levies or other charges with respect to any royalty or other amount payable
under this Agreement by Roche to Eleven despite Roche’s compliance with
Section 10.3, then Roche shall promptly pay such tax, levy or charge for and on
behalf of Eleven to the proper governmental authority, and shall promptly
furnish Eleven with receipt of payment, in which case Roche shall be entitled to
deduct the amount of any such tax, levy or charge actually paid from any royalty
or other payment due Eleven. Each Party agrees to reasonably assist the other
Party in claiming exemption from such deductions or withholdings under double
taxation or similar agreement or treaty from time to time in force and in
minimizing the amount required to be so withheld or deducted, including by
providing or filing any relevant certificate or other document.

All royalties and payments due to Eleven under the terms of this Agreement are
expressed to be exclusive of value added tax (VAT). If VAT applies the VAT
amount will be added to any royalties and payments under this Agreement.

12.

Auditing

12.1

Eleven Right to Audit

Roche shall keep, and shall require its Affiliates and Sublicensees to keep,
full, true and accurate books of account containing all particulars that may be
necessary for the purpose of calculating all royalties payable under this
Agreement. Such books of accounts shall be kept at their principal place of
business. At the expense of Eleven, Eleven shall have the right to engage an
internationally recognized independent public accountant reasonably acceptable
to Roche to perform, on behalf of Eleven, an audit of such books and records of
Roche and its Affiliates and Sublicensees that are deemed necessary by the
independent public accountant to report on Net Sales of Licensed Product

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for the period or periods requested by Eleven and the correctness of any
financial report or payments made under this Agreement.

Upon timely request and at least sixty (60) working days' prior written notice
from Eleven, such audit shall be conducted in the countries specifically
requested by Eleven, during regular business hours in such a manner as to not
unnecessarily interfere with Roche's normal business activities. Such audit
shall be limited to results in the three (3) Calendar Years prior to audit
notification. Accordingly if Eleven does not request an audit of a given
Calendar Year for a given country on or before the third (3rd) anniversary of
the end of such Calendar Year, then Eleven will be deemed to have accepted the
royalty payments and reports for such country in such Calendar Year.

Such audit shall not be performed more frequently than once per Calendar Year
nor more frequently than once with respect to records covering any specific
period of time.

All information, data documents and abstracts herein referred to shall be used
only for the purpose of verifying royalty statements, shall be treated as
Roche’s Confidential Information subject to the obligations of this Agreement
and need neither be retained more than one (1) year after completion of an audit
hereof, if an audit has been requested; nor more than three (3) years from the
end of the Calendar Year to which each shall pertain; nor more than one (1) year
after the date of termination of this Agreement.

12.2

Audit Reports

The auditors shall only state factual findings in the audit reports and shall
not interpret this Agreement. The auditors shall share all draft audit findings
with Roche before sharing such findings with Eleven and before the final audit
report is issued. The final audit report shall be shared with Roche at the same
time it is shared with Eleven.

12.3

Over- or Underpayment

If the audit reveals an overpayment, Eleven shall reimburse Roche for the amount
of the overpayment within thirty (30) days. If the audit reveals an
underpayment, Roche shall make up such underpayment with the next royalty
payment or, if no further royalty payments are owed by Roche, Roche shall
reimburse Eleven for the amount of the underpayment within thirty (30) days.
Roche shall pay for the audit costs if the underpayment of Roche exceeds five
percent (5%) of the aggregate amount of royalty payments owed with regard to the
royalty statements subject of the audit. Section 10.2 shall apply to this
Section 12.3.

13.

Intellectual Property

13.1

Prosecution of Primary Eleven Patent Rights

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13.1.1

Prior to Exercising Buy-out Option

Until such time as Roche exercises a Buy-out Option (or after the Second Option
Period if Roche fails to timely exercise both Buy-out Options), Roche shall, at
its own expense and, at Eleven’s request, in consultation with Eleven, Handle
all
(i)
Core Patent Rights and

(ii)
other Eleven Patent Rights (excluding Non-Prosecution Patent Rights) claiming
Products or any Compound therein (or any uses thereof) for a Product that has
reached at least Initiation of a Phase I Study in development by or on behalf of
a member of the Roche Group,

collectively the “Primary Eleven Patent Rights”.

During such time,
(a)
Roche shall use Commercially Reasonable Efforts to Handle Primary Eleven Patent
Rights, without Roche taking into account the payment reductions under this
Agreement that would occur if any such Patent Rights were not to exist or if any
applicable Composition of Matter Claim were not to exist.

(b)
Should Roche decide that it does not desire to Handle a Primary Eleven Patent
Right, it shall promptly advise Eleven thereof in writing in sufficient time as
is reasonably needed for Eleven to not lose any rights with respect to such
Primary Eleven Patent Right. Eleven may thereafter Handle the same at Eleven’s
own cost, to the extent that Eleven desires to do so.

13.1.2

After Exercising Buy-out Option

After such time as Roche exercises a Buy-out Option, Roche may Handle all
Primary Eleven Patent Rights (except those which Roche previously opted not to
Handle under Section 13.1.1) at its own expense and discretion and without
consultation with Eleven. Roche shall not be required to use Commercially
Reasonable Efforts to Handle such Primary Eleven Patent Rights and shall not be
required to advise Eleven if it desires to discontinue the Handling of a given
Primary Eleven Patent Right or be required to allow Eleven to continue Handling.
If Roche so requests, Eleven will, at Roche’s expense, assign to Roche all of
Eleven’s ownership rights under such Primary Eleven Patent Rights designated by
Roche that are owned by Eleven (such rights, upon assignment, the “Eleven
Assigned Patent Rights”). Eleven shall provide copies of lab notebooks and
inventor contact information as may be necessary for Roche to assume ownership
responsibility for such Eleven Assigned Patent Rights.

13.2

Prosecution of Select Non-Prosecution Patent Rights

Eleven shall, at its own expense and discretion, Handle Non-Prosecution Patent
Rights, except with respect to the Non-Prosecution Patent Rights listed in
Appendix 13.2 (the “Select Non-Prosecution Patent Rights”), (i) Eleven will not
claim any Eleven Compounds per se in the Select Non-Prosecution Patent Rights
without the consent of Roche and (ii) Eleven will timely consult with Roche
(unless Roche waives such right in writing) on the Handling of the Select
Non-Prosecution Patent Rights so as to provide Roche with an opportunity to
recommend any changes (which changes Eleven may not unreasonably refuse) that
Roche reasonably believes are necessary to avoid damage to the Core Patent
Rights listed in the Appendix 1.30 table headed “Improved IL-6 Antibodies” and
patents and patent applications claiming priority from such Patent Right and any
substitution, extension or supplementary protection certificate, reissue,
reexamination, renewal, divisional, continuation or

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continuation-in-part of any of the foregoing; provided, however, that Eleven may
abandon any Select Non-Prosecution Patent Right without consultation with or
consent of Roche.

13.3

Patent Coordination Liaison

Where the Parties need to consult with or seek the assistance of each other on
the Handling of Patent Rights, the Parties shall each nominate a patent liaison
and shall adopt procedures for interacting on patent matters. Each Party shall
reasonably cooperate and assist each other to effect the transfer of
responsibility for such Handling of Patent Rights, and shall reasonably assist
the other Party in such Handling where needed, including the execution of
necessary authorizations and assignments and take such other actions as may be
reasonably requested in the Handling of such Patent Rights.

13.4

Infringement

Each Party shall promptly provide written notice to the other Party during the
Agreement Term of any
(i)
known infringement or suspected infringement by a Roche Group Third Party of any
Valid Claim of the Primary Eleven Patent Rights through the unauthorized
manufacture, use, sale or importation of a Licensed Compound or Licensed
Product, or

(ii)
known or suspected unauthorized use or misappropriation by a Roche Group Third
Party of any Eleven Know-How in the unauthorized manufacture, use, sale or
importation of a Licensed Compound or Licensed Product by such Roche Group Third
Party,

and shall provide the other Party with all factual evidence in its possession
supporting such infringement or unauthorized use or misappropriation.

Within sixty (60) days after Roche provides or receives such written notice or
such shorter period of time as is reasonably necessary for Eleven to avoid loss
of material enforcement rights or remedies (unless such shorter period is not
possible under the circumstances) (“Decision Period”), Roche, in its sole
discretion, shall decide whether or not to initiate a suit or action in the
Territory regarding such infringement or unauthorized use or misappropriation
and shall notify Eleven of its decision in writing (“Suit Notice”).

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If Roche decides to bring a suit or take action, once Roche provides Suit
Notice, Roche shall commence such suit or take such action. In the event that
Roche (i) does not in writing advise Eleven within the Decision Period that
Roche will commence suit or take action, or (ii) fails to commence suit or take
action within a reasonable time after providing Suit Notice, Eleven shall
thereafter have the right (subject to Roche’s written consent, which except for
Eleven Assigned Patent Rights is not to be unreasonably withheld) to commence
suit or take action and shall provide written notice to Roche of any such suit
commenced or action taken by Eleven.

Upon written request, the Party bringing suit or taking action (“Initiating
Party”) shall keep the other Party informed of the status of any such suit or
action and shall provide the other Party with copies, to the extent the
Initiating Party is lawfully permitted to do so, of all substantive documents or
communications filed in such suit or action. The Initiating Party shall have the
sole and exclusive right to select counsel for any such suit or action.

The Initiating Party shall, except as provided below, pay all expenses of the
suit or action, including the Initiating Party’s attorneys’ fees and court costs
(and such costs of the other Party if participating at the Initiating Party’s
request). Unless otherwise agreed by the Parties, and subject to the Parties’
respective obligations under Article 15, all monies recovered upon the final
judgment or settlement of any action described in this Section 13.4 shall be
used as follows:
(a)    First, to reimburse the Initiating Party for its costs and, if any
remains, to the other Party for any advisory counsel fees and costs not already
reimbursed by the Initiating Party; and
(b)    Second,
(i)
if a member of the Roche Group is the Initiating Party,

(A)
any remaining amount that represents compensation for lost sales, a reasonable
royalty or lost profits, shall be retained by or paid to the Initiating Party;
provided, however, any such amount (after relevant adjustment to convert to Net
Sales of Products) shall be subject to the royalty obligations set forth in
Section 9.3; and

(B)
any remaining amount that represents additional damages (e.g., enhanced or
punitive damages) shall be allocated to Roche; and

(ii)
if Eleven is the Initiating Party, the balance, if any, shall be allocated
seventy five percent (75%) to the Initiating Party, and twenty five percent
(25%) to the other Party.

If the Initiating Party believes it is reasonably necessary or desirable to
obtain an effective remedy, upon written request the other Party agrees to be
joined as a party to the suit or action but shall be under no obligation to
participate except to the extent that such participation is required as the
result of its being a named party to the suit or action, all of which shall be
at the Initiating Party’s expense. At the Initiating Party’s written request,
the other Party shall offer reasonable assistance to the Initiating Party in
connection therewith at no charge to the Initiating Party except for
reimbursement of reasonable out-of-pocket expenses incurred by the other Party
in rendering such assistance. The other Party shall have the right to
participate and be represented in any such suit or action by its own counsel at
its own expense.

The Initiating Party may settle, consent to judgment or otherwise voluntarily
dispose of the suit or action (“Settlement”) without the written consent of the
other Party but only if such Settlement can be achieved without adversely
affecting the other Party (including any of its Patent Rights). If a Settlement
could materially adversely affect the other Party, then the written consent of
the other Party would be

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required, which consent shall not be unreasonably withheld, however if the other
Party is unable to timely respond, then such consent shall be deemed as granted.

For clarity, Roche shall be solely responsible, at its own expense and
discretion, for responding to the infringement of any Eleven Assigned Patent
Rights, and will receive all monies recovered upon the final judgment or
settlement of any action taken by Roche in connection therewith. If a Settlement
could materially adversely affect Eleven, then the written consent of Eleven
would be required, which consent shall not be unreasonably withheld, however if
Eleven is unable to timely respond, then such consent shall be deemed as
granted. Eleven will reasonably assist Roche in any such actions, at Roche’s
expense.

13.5

Defense

Subject to Article 15, if an action for infringement is commenced against either
Party, its licensees or its sublicensees related to the discovery, development,
manufacture, use or sale of a Product, then Roche shall have the right (but not
the obligation) to defend such action at its own expense, and Eleven shall
assist and cooperate with Roche, at Roche’s expense, to the extent necessary in
the defense of such suit. Roche shall have the right to settle the suit or
consent to an adverse judgment thereto, in its sole discretion, so long as such
settlement or adverse judgment does not adversely affect the rights of Eleven.
Roche shall assume full responsibility for the payment of any award for damages,
or any amount due pursuant to any settlement entered into by it with such Third
Party.

13.6

Common Interest Disclosures

With regard to any information or opinions about intellectual property disclosed
pursuant to this Agreement between the Parties, the Parties agree that, to the
extent possible under Applicable Law, they have a common legal interest in
(i) determining whether, and to what extent, Third Party intellectual property
rights may affect Compounds or Products and (ii) defending against any actual or
prospective Third Party claims based on allegations of misuse or infringement of
intellectual property rights relating to Compounds or Products. Accordingly, the
Parties agree that, to the extent possible under Applicable Law, (i) all such
relevant information or opinions obtained by Eleven and Roche from each other
will be used solely for purposes of the Parties’ common legal interests with
respect to the conduct of the Agreement; (ii) all such information and materials
will be treated as protected by the attorney-client privilege, the work product
privilege, the joint defense privilege, the common interest privilege, and any
other privilege or immunity that may otherwise be applicable; (iii) by sharing
any such information and materials, neither Party intends to waive or limit any
privilege or immunity that may apply to the shared information and materials.
Nothing in this Section 13.6 shall prevent either Roche or Eleven from claiming
a common interest privilege in any other matter properly subject to that
privilege. Neither Party shall have the authority to waive any privilege or
immunity on behalf of the other Party without such other Party’s prior written
consent, nor shall the waiver of privilege or immunity resulting from the
conduct of one Party be deemed to apply against any other Party.

It is expressly understood that nothing contained in this Section 13.6 shall
limit the right of either Party to disclose to anyone (or withhold disclosure
from anyone) any of their own documents and information, as they see fit.

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13.7

Biosimilar or interchangeable biological products

Notwithstanding anything herein to the contrary, within four (4) years after the
approval of a Product that has been licensed in the US as a biological product
under 42 USC §262(a), and as may be needed from time to time thereafter, upon
request by Roche, the Parties shall consult as to potential strategies with
respect to unexpired US Primary Eleven Patent Rights Controlled by Eleven that
Cover the Product. Specifically, in anticipation of a receipt by the Product’s
reference product sponsor (“Reference Product Sponsor”) of a biosimilar or
interchangeable product application pursuant to the Biologics Price Competition
and Innovation Act of 2009 (Public Law 111-148), the Parties will discuss the
Reference Product Sponsor’s likely course of action with regard to US Primary
Eleven Patent Rights in the procedural steps set forth under 42 USC §262(l),
including a general plan for timely communication between the Parties in light
of the statutory response deadlines.

13.8

Patent Term Extensions

The Parties shall use Commercially Reasonable Efforts to obtain all available
patent term extensions, adjustments or restorations, or supplementary protection
certificates (“SPCs”, and together with patent term extensions, adjustments and
restorations, “Patent Term Extensions”) for Primary Eleven Patent Rights. Eleven
shall execute such authorizations and other documents and take such other
actions as may be reasonably requested by Roche to obtain such Patent Term
Extensions, including designating Roche as its agent for such purpose as
provided in 35 USC § 156. All filings for such Patent Term Extensions shall be
made by Roche; provided, that in the event that Roche elects not to file for a
Patent Term Extension for a Primary Eleven Patent Right, Roche shall
(i) promptly inform Eleven of its intention not to file and (ii) grant Eleven
the right to file for such Patent Term Extension. Each Party shall execute such
authorizations and other documents and take such other actions as may be
reasonably requested by the other Party to obtain such extensions. The Parties
shall cooperate with each other in gaining patent term restorations, extensions
or SPCs wherever applicable to such Primary Eleven Patent Rights.

13.9

Consent to File Patent Applications

Eleven hereby provides consent under Section 4(f) of the Material Transfer
Agreement by and between the Parties effective November 18, 2015, as amended
(the “MTA”).

14.

Representations and Warranties

14.1

Eleven Representations and Warranties

Eleven represents and warrants to Roche, in each case as of the Signature Date
(except with respect to any such statement that is expressly made as of a
specific date, which representation and warranty shall be as of such date):
14.1.1

Safety Data

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(a)
Eleven has disclosed to Roche and, to the extent set forth in Section 5.2, will
promptly disclose to Roche the results of all preclinical testing of Licensed
Product in its Control.

(b)
Eleven has not conducted human clinical testing of any Licensed Product. In
accordance with Section 5.2, Eleven will disclose to Roche all information in
its Control concerning side effects, injury, toxicity or sensitivity reaction
and incidents or severity thereof in humans with respect to Licensed Product.

14.1.2

Ownership of Patent Rights

Eleven is the exclusive owner of all right, title and interest in, or is the
exclusive licensee of, the Eleven Base Patent Rights existing on the Signature
Date. Appendix 1.30 and Appendix 13.2 collectively contain a complete and
accurate list of all Patent Rights Controlled by Eleven as of the Signature Date
that Cover Eleven Compounds. Between the Signature Date and the Effective Date,
Eleven will have used Commercially Reasonable Efforts to prosecute or maintain
the Core Patent Rights and has not granted and will not grant rights to any
Third Party under the Eleven Base Patent Rights that conflict with the rights
granted to Roche hereunder.
14.1.3

Third Party Eleven IP

To the knowledge of Eleven, the Third Party Eleven IP does not Cover or relate
to Compounds or Products, and the scope of the Third Party Eleven IP does not
overlap with the Eleven Base Patent Rights.
14.1.4

Inventors

Eleven warrants that the inventors of the inventions disclosed or claimed in
Eleven Patent Rights have transferred to Eleven full ownership of the Patent
Rights licensed under this Agreement.
14.1.5

Grants

To the best of Eleven’s knowledge and belief, Eleven has the lawful right to
grant Roche and its Affiliates the rights and licenses described in this
Agreement, assuming that no filing is required under the Hart Scott Rodino
Antitrust Improvements Act of 1976 (the “HSR Act”).
14.1.6

Authorization

The execution, delivery and performance of this Agreement by Eleven and all
instruments and documents to be delivered by Eleven hereunder, subject, in each
case, to the receipt of the Required Company Stockholder Vote and assuming that
no filing is required under the HSR Act: (i) are within the corporate power of
Eleven; (ii)  have been duly authorized by all necessary or proper corporate
action; (iii) are not in contravention of any provision of the certificate of
incorporation of Eleven; (iv) to the knowledge of Eleven, will not violate any
law or regulation or any order or decree of any court of governmental
instrumentality; (v) will not violate the terms of any indenture, mortgage, deed
of trust, lease, agreement, or other instrument to which Eleven is a party or by
which Eleven or any of its property is bound; and (vi) do not require any filing
or registration with, or the consent or approval of, any governmental body,
agency, authority or any other person, which has not been made or obtained

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previously (other than filings of reports, schedules or materials with the
Securities and Exchange Commission or pursuant to any applicable state
securities laws and filings with Regulatory Authorities with respect to
Products), except, in the case of clauses (iv), (v) and (vi), for any such
violations, and for any filings, registrations or consents not obtained or made,
that, individually or in the aggregate, are not reasonably likely to have a
material adverse effect on the financial condition of Eleven or on the ability
of Eleven to perform its obligations hereunder.
14.1.7

Validity of Patent Rights

Eleven is not in possession of information that Eleven reasonably believes could
render invalid or unenforceable any claims that are in any of the Primary Eleven
Patent Rights existing on the Signature Date. Eleven has no knowledge of any
inventorship disputes concerning any Eleven Patent Rights.
14.1.8

Ownership and Validity of Know-How

The Eleven Know-How is legitimately in the possession of Eleven and has not been
misappropriated from any Third Party. Eleven has taken reasonable measures to
protect the confidentiality of the Eleven Know-How.
14.1.9

No Claims

There are no claims or investigations, pending or, to Eleven’s knowledge,
threatened against Eleven, at law or in equity, or before or by any governmental
authority relating to the matters contemplated under this Agreement that would
materially and adversely affect Eleven’s ability to perform its obligations
hereunder.
14.1.10

Scope of License

On the Signature Date and Effective Date, Eleven has not granted any rights to
another entity that would reduce the scope of the license to Roche contemplated
by this Agreement.

14.2

Roche Representations and Warranties

Roche represents and warrants to Eleven, in each case as of the Signature Date
(except with respect to any such statement that is expressly made as of a
specific date, which representation and warranty shall be as of such date):
14.2.1

Authorization

The execution, delivery and performance of this Agreement by Roche and all
instruments and documents to be delivered by Roche hereunder: (i) are within the
corporate power of Roche; (ii) have been duly authorized by all necessary or
proper corporate action; (iii) are not in contravention of any provision of the
certificate of formation or limited liability company agreement of Roche;
(iv) to the knowledge of Roche, will not violate any law or regulation or any
order or decree of any court of governmental instrumentality; (v) will not
violate the terms of any indenture, mortgage, deed of trust, lease, agreement,
or other instrument to which Roche is a party or by which Roche or any of its
property

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is bound; and (vi) do not require any filing or registration with, or the
consent or approval of, any governmental body, agency, authority or any other
person, which has not been made or obtained previously (other than filings with
the Securities and Exchange Commission or pursuant to any applicable state
securities laws and filings with Regulatory Authorities with respect to
Products), except, in the case of clauses (iv), (v) and (vi), for any such
violations, and for any filings, registrations or consents not obtained or made,
that, individually or in the aggregate, are not reasonably likely to have a
material adverse effect on the financial condition of Roche or on the ability of
Roche to perform its obligations hereunder.
14.2.2

No Claims

There are no claims or investigations, pending or, to Roche’s knowledge,
threatened against Roche, at law or in equity, or before or by any governmental
authority relating to the matters contemplated under this Agreement that would
materially adversely affect Roche’s ability to perform its obligations
hereunder.

14.3

No Other Representations

EXCEPT AS OTHERWISE PROVIDED IN THIS AGREEMENT, THE FOREGOING REPRESENTATIONS
AND WARRANTIES ARE THE SOLE AND EXCLUSIVE REPRESENTATIONS AND WARRANTIES,
EXPRESS, STATUTORY OR IMPLIED AND WHETHER WRITTEN OR ORAL RELATED TO THE SUBJECT
MATTER OF THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF PRODUCTS OR
NON-INFRINGEMENT. ROCHE HAS RELIED SOLELY UPON ITS OWN INVESTIGATION AND
ANALYSIS AND THE REPRESENTATIONS AND WARRANTIES OF ELEVEN EXPRESSLY SET FORTH IN
THIS AGREEMENT.

15.

Indemnification

15.1

Indemnification by Roche

Roche shall indemnify, hold harmless and defend Eleven and its directors,
officers, employees and agents (collectively, “Eleven Indemnitees”) from and
against any and all losses, expenses, cost of defense (including without
limitation attorneys' fees, witness fees, damages, judgments, fines and amounts
paid in settlement) and any amounts Eleven becomes legally obligated to pay,
because of a claim by a Roche Group Third Party, to the extent resulting from
the breach of the Agreement by Roche or activities related to the Licensed
Product (e.g., product liability claims) conducted by or on behalf of a member
of the Roche Group (other than by Eleven Indemnitees), except to the extent such
losses, expenses, costs and amounts are due to the breach of the Agreement by
Eleven or the gross negligence or willful misconduct or failure to act of Eleven
Indemnitees.

15.2

Indemnification by Eleven

Eleven shall indemnify, hold harmless and defend Roche and its directors,
officers, employees and agents (collectively, “Roche Indemnitees”) from and
against any and all losses, expenses, cost of

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defense (including without limitation attorneys' fees, witness fees, damages,
judgments, fines and amounts paid in settlement) and any amounts Roche becomes
legally obligated to pay, because of a claim by a Roche Group Third Party, to
the extent resulting from the breach of the Agreement by Eleven or activities
related to the Licensed Product (e.g., product liability claims) conducted by or
on behalf of Eleven (other than by Roche Indemnitees or any member of the Roche
Group), except to the extent such losses, expenses, costs and amounts are due to
the breach of the Agreement by Roche or the gross negligence or willful
misconduct or failure to act of Roche Indemnitees or any member of the Roche
Group.

15.3

Procedure

In the event of a claim by a Roche Group Third Party against a Party 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 and its settlement. The
Indemnified Party shall cooperate with the Indemnifying Party 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 otherwise
agrees in writing.

16.

Liability

16.1

Limitation of Liability

(a)

Subject to Article 3, neither Party shall be liable to the other Party as a
result of failure or delay to develop or commercialize the Licensed Compound or
the Licensed Product, as applicable, including but not limited to, a) a delay in
timelines, or b) delay or failure to recruit patients, or c) a change in its
respective study protocols, or d) failure of the other Party to obtain
Regulatory Approval for the Licensed Compound or the Licensed Product, as
applicable.

(b)

EXCEPT FOR INDEMNIFICATION UNDER ARTICLE 15, NEITHER PARTY SHALL BE ENTITLED TO
RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL, INDIRECT OR
PUNITIVE DAMAGES, OR LOST PROFITS, IN CONNECTION WITH THIS AGREEMENT OR ANY
LICENSE GRANTED HEREUNDER REGARDLESS OF THE FORM OF ACTION THROUGH WHICH ANY OF
THE FOREGOING ARE SOUGHT.

16.2

Coordination

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Roche Basel and Roche US shall coordinate the exercise of Roche’s rights under
this Agreement. Roche Basel and Roche US shall be jointly and severally liable
for Roche’s obligations under this Agreement.

17.

Obligation Not to Disclose Confidential Information

17.1

Non-Use and Non-Disclosure

During the Agreement Term and for five (5) years thereafter, a Receiving Party
shall (and shall require its Affiliates to) (i) treat Confidential Information
provided by Disclosing Party as it would treat its own information of a similar
nature, (ii) take all reasonable precautions not to disclose such Confidential
Information to Third Parties, without the Disclosing Party’s prior written
consent, and (iii) not use such Confidential Information other than for
fulfilling its obligations or exercising its rights under this Agreement.

17.2

Permitted Disclosure

Notwithstanding the obligation of non-use and non-disclosure set forth in
Section 17.1, the Parties recognize the need for certain exceptions to this
obligation, specifically set forth below, with respect to press releases, patent
rights, publications, and certain commercial considerations.

17.3

Press Releases

(a)
The Parties may issue solely or jointly the press releases announcing the
existence and selected key terms of this Agreement, in a form substantially
similar to the templates attached as Appendix 17.3.

(b)
Eleven shall only issue other press releases related to the activities
contemplated by this Agreement that either (i) have been approved by Roche or
(ii) are required to be issued by Eleven as a matter of law based on advice of
legal counsel. In all such circumstances, Eleven shall provide Roche with a
draft press release at least two (2) weeks prior to its intended publication for
Roche's review. During such period, Roche shall (i) approve the draft press
release and permit Eleven to issue the press release, (ii) contact Eleven to
discuss modification to the draft press release, or (iii) contact Eleven and
disapprove the press release. If Roche asks for modification, then Eleven shall
either make such modification or work with Roche to arrive at a press release
that Roche approves.

(c)
Notwithstanding anything else to the contrary in this Agreement, Eleven may
issue press releases or announcements, make filings or submissions or otherwise
publicly disclose information regarding this Agreement and the transactions
contemplated hereby without the prior written consent of Roche to the extent
required by Applicable Law or the rules or regulations of any applicable U.S. or
non-U.S. securities exchange or regulatory governmental body to which it is
subject to or submits to, including any disclosures contained in proxy or other
similar materials issued in connection with the Stockholder Voting Proposal;
provided, however, the issuance by Eleven of any such press release without
following the procedures of Section 17.3(b) must be based on advice of legal
counsel that the release was required to be issued by Eleven as a matter of law.
Notwithstanding the foregoing, in all such cases Eleven shall use Commercially
Reasonable

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Efforts to provide Roche an advance draft press release, announcement, filing or
submission as applicable as soon as reasonably practicable and consider in good
faith Roche’s reasonable and timely comments prior to publicly issuing its final
version.

(d)
To the extent the content of any press release or other announcement has been
made in accordance with this Section 17.3 or with Section 17.4, no separate
approval shall be required in respect of such content to the extent replicated
in whole or in part in any subsequent press release or other announcement.

(e)
To ensure communication alignment, responses (if any) to inquiries by media or
other Third Parties (other than inquiries by any governmental authority, body,
agency or other instrumentality) after issuance of a permitted press release by
Eleven (solely or jointly with Roche) shall consist solely of the press release
language or shall follow the response guidelines that may be mutually developed
by the Parties.

17.4

Commercial Considerations

(a)

After the Effective Date, nothing in this Agreement shall prevent Roche or its
Affiliates from disclosing Confidential Information of Eleven to
(i) governmental agencies to the extent required or desirable to secure
government approval for the development, manufacture or sale of Product in the
Territory, (ii) Third Parties acting on behalf of Roche, to the extent
reasonably necessary for the development, manufacture or sale of Product in the
Territory, or (iii) Third Parties to the extent reasonably necessary to market
the Product in the Territory.

(b)

Either Party may disclose this Agreement to actual or potential licensees,
sublicensees, acquirers or investors under terms of confidentiality no less
stringent than in this Agreement.

(c)

The Receiving Party may disclose Confidential Information of the Disclosing
Party to the extent that such Confidential Information is required to be
disclosed by the Receiving Party to comply with Applicable Law, to defend or
prosecute litigation or to comply with governmental regulations, provided that
the Receiving Party provides prior written notice of such disclosure to the
Disclosing Party, if possible, and, to the extent practicable, takes reasonable
and lawful actions to minimize the degree of such disclosure.

(d)

The Parties acknowledge that either or both Parties may be obligated to make one
or more filings (including to file a copy of this Agreement) with the U.S.
Securities and Exchange Commission (or equivalent foreign agency) or a
governmental authority. Each Party will be entitled to make such a required
filing, provided that it will (i) submit in connection with such filing a copy
of this Agreement in a form mutually agreed by the Parties in advance or, if
despite the commercially reasonable efforts of Eleven a form mutually agreed by
the Parties cannot be agreed in advance, redacted to the extent permitted by
Applicable Law (the “Redacted Agreement”), (ii) request, and use commercially
reasonable efforts consistent with Applicable Laws to obtain, confidential
treatment of all terms redacted from this Agreement, as reflected in

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the Redacted Agreement, for a period of at least ten (10) years, (iii) to the
extent consistent with Applicable Law, promptly deliver to the other Party any
written correspondence received by it or its representatives from the U.S.
Securities and Exchange Commission (or equivalent foreign agency) or a
governmental authority with respect to such confidential treatment request and
promptly advise the other Party of any other material communications between it
or its representatives with the U.S. Securities and Exchange Commission (or
equivalent foreign agency) or a governmental authority with respect to such
confidential treatment request, (iv) upon the written request of the other
Party, if legally justifiable, request an appropriate extension of the term of
the confidential treatment period, and (v) if the U.S. Securities and Exchange
Commission (or equivalent foreign agency) or a governmental authority requests
any changes to the redactions set forth in the Redacted Agreement, use
commercially reasonable efforts consistent with Applicable Laws to support the
redactions in the Redacted Agreement as originally filed and not agree to any
changes to the Redacted Agreement without, to the extent practical, first
discussing such changes with the other Party and taking the other Party’s
comments into consideration when deciding whether to agree to such changes
(provided that a Party will only be required to make such efforts to support
such redactions once). For clarity, following a request from a governmental
authority to change the redactions requested by a Party, a Party will not be
required pursuant to the provisions of this Section 17.4(d) to again request the
redactions rejected by the applicable governmental authority. Each Party will be
responsible for its own legal and other external costs in connection with any
such filing, registration or notification.

18.

Agreement Expiration and Termination

18.1

Commencement and Expiration

This Agreement shall commence upon the date hereof (except for Sections 2.2 and
2.3, Articles 3-15 (except for Sections 9.5 and 14.3, which shall be effective
as of the Signature Date) and Sections 18.2.1-18.2.4, 18.3, 18.4, 21.5 and 21.12
which shall commence as of the Effective Date, and except for such other
provisions of this Agreement which expressly commence as of a specific date,
which shall commence as of such date) and, unless earlier terminated under
Section 18.2, shall expire on the Expiration Date.

18.2

Termination

18.2.1

Termination for Material Breach After the Effective Date

After the Effective Date, a Party (“Non-Breaching Party”) shall have the right
to terminate this Agreement in its entirety or on a country-by-country basis in
the event the other Party (“Breaching Party”) is in breach of any of its
material obligations under this Agreement. The non-Breaching Party shall provide
written notice to the Breaching Party, which notice shall identify the breach
and the countries in which the Non-Breaching Party intends to have this
Agreement terminate. The Breaching Party shall have a period of ninety (90) days
after such written notice is provided (“Peremptory Notice Period”) to cure such
breach. If the Breaching Party has a bona fide dispute as to whether such breach

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occurred or has been cured, it will so notify the Non-Breaching Party, and the
expiration of the Peremptory Notice Period shall be tolled until such dispute is
resolved pursuant to Sections 21.2 or 21.3. Upon a determination of breach or
failure to cure, the Breaching Party may have the remainder of the Peremptory
Notice Period to cure such breach. If such breach is not cured within the
Peremptory Notice Period, then absent withdrawal of the Non-Breaching Party’s
request for termination, this Agreement shall terminate in its entirety or such
identified countries effective as of the expiration of the Peremptory Notice
Period.
18.2.2

Termination by Roche without Cause After the Effective Date

After the Effective Date, Roche shall have the right to terminate this Agreement
at any time as a whole or on a Product-by-Product or country-by-country basis
upon ninety (90) days prior written notice before First Commercial Sale in the
Territory or upon one hundred eighty (180) days prior written notice after the
First Commercial Sale in the Territory. The effective date of termination under
this Section 18.2.2 shall be the date ninety (90) days (or one hundred eighty
(180) days as the case may be) after Roche provides such written notice to
Eleven.
18.2.3

Termination by Eleven for Development Discontinuation After the Effective Date

After the Effective Date, Eleven shall have the right to terminate this
Agreement upon written notice if, prior to the first BLA Filing for a Licensed
Product, the Roche Group has discontinued material development of all Licensed
Products for the previous twelve (12) consecutive months, and such
discontinuations were not due to events outside of the reasonable control of the
Roche Group (including actions taken by Regulatory Authorities, or any Third
Party litigation relating to the safety of a Licensed Product).
18.2.4

Termination for Eleven Debarment

After the Effective Date, Roche shall have the right to terminate this Agreement
upon written notice for Eleven’s debarment in accordance with Section 21.5.
18.2.5

Termination by a Party Prior to the Effective Date

(a)
Eleven will inform Roche of the date of the Company Meeting at which a vote of
the Stockholder Voting Proposal is to be taken. Eleven will inform Roche of the
results of the Company Meeting at which a vote on the Stockholder Voting
Proposal was taken within one (1) Business Day of such meeting. Eleven will
inform Roche within one (1) Business Day of a decision by the Board of Directors
of Eleven to approve or recommend to the stockholders any Alternative
Transaction from a Qualified Person.

(b)
Prior to the Effective Date, if, at the Company Meeting at which a vote on the
Stockholder Voting Proposal is taken, the Required Company Stockholder Vote in
favor of the Stockholder Voting Proposal is not obtained, this Agreement shall
automatically terminate as of the date of such Company Meeting at which such
vote on the Stockholder Voting Proposal was taken.

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(c)
Prior to the Effective Date, Roche shall have the right to terminate this
Agreement upon written notice if the Company Meeting at which a vote on the
Stockholder Voting Proposal is taken does not occur on or prior to the
seventy-fifth (75th) day following the Signature Date.

(d)
Prior to the Effective Date, either Party shall have the right to terminate this
Agreement upon written notice if the Board of Directors of Eleven shall have
approved or recommended to the stockholders any Alternative Transaction from a
Qualified Person.

18.3

Consequences of Termination

This Section 18.3 only applies to termination under Section 18.2.1-18.2.4.
18.3.1

Termination for Eleven Breach or Debarment

Upon any termination by Roche under Section 18.2.1 (material breach by Eleven)
or 18.2.4 (Eleven debarment), the rights and licenses granted by Eleven to Roche
under this Agreement shall terminate in their entirety or on a
country-by-country and Product-by-Product basis, as applicable, on the effective
date of termination. In the event of a material breach by Eleven or Eleven’s
debarment, if the Roche Group elects not to terminate this Agreement, Roche
shall be entitled to seek remedies, including but not limited to damages and
reduction of payment obligations in Article 9, subject to the terms and
conditions of this Agreement.
18.3.2

Roche Activated Termination

Upon any Roche Activated Termination, the rights and licenses granted by Eleven
to Roche under this Agreement shall terminate in their entirety or on a
country-by-country and Product-by-Product basis, as applicable, on the effective
date of termination. The Continuation Election Evaluation Process corresponding
to an Involuntary Termination shall begin on the effective date of termination;
the Continuation Election Evaluation Process corresponding to a Voluntary
Termination shall begin on the date Roche provides its notice of termination to
Eleven (each such date, a “CEEP Start Date”).

During the Continuation Election Evaluation Process, Roche shall continue
activities, including preparatory activities, ongoing as of the CEEP Start Date
with respect to the relevant Returnable Product(s). However, Roche shall not be
obliged to initiate any new activities not ongoing as of the CEEP Start Date
except as expressly set forth herein and except that Roche shall initiate such
new activities at Eleven’s reasonable written request and expense. Where
possible the Alliance Directors will cooperate with each other to facilitate
meeting Eleven’s reasonable requests for information and continuation of
activities reasonably needed for Eleven’s bona fide intention to continue
development of the Returnable Product(s) while minimizing Roche’s investment in
labor and expenses during the Continuation Election Evaluation Process.

Within ten (10) days after the CEEP Start Date, Roche shall have the opportunity
(but not the obligation) to provide Eleven with either such information as Roche
would like Eleven to consider or a notification waiving the right to provide
such information. Within twenty (20) days after the CEEP Start Date, Eleven
shall communicate to Roche either (x) a non-binding statement of continued
interest in developing the specified Returnable Product(s) or (y) a binding
waiver of Eleven’s right to submit a Continuation Election Notice. If Eleven
elects to communicate the latter or fails to communicate with Roche, then

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Eleven shall have been deemed to have not provided a timely Continuation
Election Notice and Section 18.3.4.1 shall apply. If Eleven elects to
communicate the former, Roche shall promptly populate a secure data room with
such material information pertaining to the applicable Roche Group’s
development, manufacturing and commercialization activities for such Returnable
Product(s) as is reasonably necessary for Eleven to make an informed decision as
to whether to submit a Continuation Election Notice, which data room shall be
fully populated and opened for Eleven’s access no later than thirty (30) days
after Eleven’s communication of a non-binding indication of interest under
clause (x) above. Roche shall make the relevant personnel available for Eleven’s
reasonable follow-up questions and requests pertaining to such information, and
Roche shall disclose such additional materials as are reasonably necessary to
respond to Eleven’s requests. Notwithstanding anything in this Section, such
data room and personnel follow-up is not intended to provide Eleven with a
similar scope of information or follow-up as would be required and commensurate
with types of investment and diligence commitment Roche has made to Eleven under
this Agreement, nor is it a substitute for Roche Transfer Activities that are
reimbursed in accordance with Section 18.3.4.3(d); rather it is intended to be a
process to minimize Roche’s continuation activity costs where not required;
provided, however, that the data provided in the data room must be adequate for
Eleven to make a reasonably informed decision regarding the Continuation
Election Notice. If Eleven desires to continue development or commercialization
of Returnable Product(s), Eleven shall give a Continuation Election Notice to
Roche within forty (40) days after the data room is reasonably populated and
open for Eleven’s access; if during such forty (40) day period, Eleven does not
have a bona fide interest in pursuing development, Eleven shall promptly notify
Roche.

After Roche’s receipt of a timely Continuation Election Notice from Eleven, to
the extent reasonably requested by Eleven with respect to the Returnable
Product(s) specified in such Continuation Election Notice:

a)
Roche shall, and shall ensure that its Affiliates shall, (and, to the extent
Roche or any of its Affiliates has the right to do so and to the extent such
sublicensees do not take a direct license in accordance with Section 18.3.3,
shall require the other members of the Roche Group to,) promptly transfer to
Eleven all regulatory filings and approvals, all final pre-clinical and clinical
study reports and clinical study protocols, and all data, including clinical
data, in their possession and control related to Returnable Product(s) necessary
for Eleven to continue to develop and commercialize the Returnable Product(s).
All data shall be transferred in the form and format in which it is maintained
by the relevant member of the Roche Group. Original paper copies shall only be
transferred, if legally required. Roche shall not be required to prepare or
finalize any new data, reports or information solely for purposes of transfer to
Eleven.

b)
Roche shall, and shall ensure that its Affiliates shall, (and, to the extent
Roche or any of its Affiliates has the right to do so and to the extent such
sublicensees do not take a direct license in accordance with Section 18.3.3,
shall require the other members of the Roche Group to,) make reasonable efforts
to promptly assign all clinical trial agreements, to the extent such agreements
have not been cancelled, are assignable without subjecting Roche to any material
liability and are assignable without Roche paying any consideration (unless
Eleven agrees to pay such consideration) or commencing litigation in order to
effect an assignment of any such agreement.

c)
Eleven shall, upon such transfer, have the right to disclose such filings,
approvals and data to (i) governmental agencies of the country to the extent
required or desirable to secure government

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approval for the development, manufacture or sale of Returnable Product(s) in
the country; (ii) Third Parties acting on behalf of Eleven, its Affiliates or
licensees, to the extent reasonably necessary solely for the development,
manufacture, or sale of Returnable Product(s) in the country, or (iii) Third
Parties to the extent reasonably necessary to market Returnable Product(s) in
the country.

d)
In exchange for Roche’s transfer of such items that were not originally provided
from Eleven to Roche under this Agreement (i.e., created or developed by or on
behalf of Roche), Eleven shall pay Roche a royalty on all net sales (as
determined by reasonable accounting methods) of such Returnable Product(s) by
Eleven, its Affiliates or licensees or sublicensees to which Eleven has licensed
or sublicensed rights other than through a Compulsory Sublicense, mutatis
mutandis, for such Returnable Product(s) (other than licensees that have a
direct license in accordance with Section 18.3.3), with the royalty rate as
follows:

Status of Returnable Product at time of termination
Royalty rate
Phase II Study Initiated
2%
Phase III Study Initiated
5%
First Commercial Sale in US or anywhere in the EU
10%

Such royalties shall be paid on a Returnable Product-by-Returnable Product and
country-by-country basis commencing on the first commercial sale of the
Returnable Product in such country by Eleven, or any of its Affiliates or any of
such of its licensees or sublicensees (other than an entity that is or was a
member of the Roche Group) and ending ten (10) years after the first commercial
sale of the Returnable Product in such country by any entity (including a member
of the Roche Group). Royalties may be reduced upon entry of a biosimilar product
in accordance with the reduction structure set forth in Section 9.3.5, and with
respect to any other reductions described in Sections 9.3.3, 9.3.4 and 9.3.6, as
if applied to Eleven, its Affiliates and licensees or sublicensees in lieu of
the Roche Group. Such payments shall be subject to the reporting and auditing
obligations comparable to those set forth in this Agreement, except with Eleven
as the licensee instead of Roche.

e)
In connection with such transfer, and in all cases subject to Section 18.3.4.3,
Eleven shall have a non-exclusive license, sublicensable through multiple tiers,
under the Roche Patent Rights and Roche Know-How, solely to the extent necessary
to allow Eleven, its Affiliates or licensees or sublicensees to register, have
registered, develop, manufacture, have manufactured, use, offer to sell, sell,
promote, export and import the Base Returnable Product associated with each
applicable Returnable Product specified in such Continuation Election Notice and
all associated applicable Modified Returnable Product(s) for such Base
Returnable Product in the applicable country(ies), with the proviso that

(i)
with respect to Early Returnable Products, unless Roche specifically agrees to
the contrary, such license shall not extend to Proprietary Manufacturing IP for
Early Returnable Products;

(ii)
with respect to Returnable Products other than Early Returnable Products, such
license does not apply to Proprietary Manufacturing IP for so long as Roche
elects to manufacture and supply such Returnable Product under
Section 18.3.4.2(c), and if Roche transfers the process to one or more Third
Party CMOs acceptable to Roche under conditions of confidentiality and non-use
acceptable to Roche in accordance with Section 18.3.4.2(c), such license of

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Proprietary Manufacturing IP shall not extend to Eleven and will instead be
limited to such Third Party CMO(s) for the sole purpose of manufacturing such
Returnable Products on behalf of Eleven, Eleven’s Affiliates or Eleven’s
licenses or sublicensees.
Eleven shall ensure that all of the applicable terms and conditions of this
Agreement shall apply to its Affiliates and licensees and sublicensees to the
same extent as they apply to Eleven for all purposes, and Eleven assumes full
responsibility for the performance of all obligations and observances of all
terms so imposed on such Affiliates, licensees and sublicensees. Eleven shall
provide Roche a copy of any such agreements with licensees and sublicensees
which may be redacted to exclude financial terms and confidential information of
Eleven or the licensee or sublicensee. For clarity, the licenses under this
Section 18.3.2(e) shall not include any licenses that Roche has with a Third
Party for which such grant would be prohibited or under which a member of the
Roche Group would incur liability or financial obligations (unless Eleven agrees
to pay such financial obligations) to such Third Party.

f)
If requested by Eleven in writing, and solely to the extent Roche is able to do
so truthfully, Roche will represent and warrant to Eleven that, as of the
effective date of the termination, Roche and its Affiliates have not been
debarred under 21 U.S.C. §335a, disqualified under 21 C.F.R. §312.70 or
§812.119, sanctioned by a Federal Health Care Program (as defined in 42 U.S.C.
§1320 a-7b(f)), including without limitation the federal Medicare or a state
Medicaid program, or debarred, suspended, excluded or otherwise declared
ineligible from any other similar Federal or state agency or program in a manner
that would materially impact the Returnable Products.

18.3.3

Direct License

Irrespective of anything to the contrary in this Agreement, any existing,
permitted sublicense granted directly by Roche under Section 2.3.2 of this
Agreement (and any further sublicenses thereunder) to any Third Party shall,
upon the written request of Roche, remain in full force and effect to the extent
that Roche had complied with its obligations under Section 2.3.2 with respect
thereto, provided that (i) each such Sublicensee and any further sublicensees
are not then in breach of its sublicense agreement (and, in the case of
termination by Eleven for material breach by Roche, that neither such
Sublicensee nor any further sublicensees caused the material breach that gave
rise to the termination by Eleven); (ii) each such direct Sublicensee agrees to
be bound to Eleven under all the terms and conditions of such sublicense
agreement; and (iii) Eleven is provided with a true and complete copy of such
sublicense agreement.
18.3.4

Other Obligations Applicable for Roche Activated Terminations

18.3.4.1

Obligations Related to Ongoing Activities

(a)
If Eleven does not provide timely a Continuation Election Notice, then Roche
(i) shall have the right to cancel all ongoing obligations with Third Parties
with respect to any terminated Returnable Product under this Agreement and
(ii) shall be permitted to complete, and be solely responsibility for, all
non-cancellable obligations with Third Parties with respect to any terminated
Returnable Product, but only at its own expense.

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(b)
If Eleven provides such timely Continuation Election Notice, then from the date
of notice of termination until (i) the effective date of termination (in the
event of a Voluntary Termination) and (ii) four (4) months after the effective
date of termination (in the event of an Involuntary Termination), Roche shall
continue activities, including preparatory activities, ongoing as of the date of
notice of termination with respect to the relevant Returnable Products, at
Roche’s expense. However, Roche shall not be obliged to initiate any new
activities not ongoing at the date of notice of termination except as expressly
set forth herein.

(c)
After the effective date of termination, Roche shall have no obligation to
perform or complete any activities or to make any payments for performing or
completing any activities under this Agreement, except as expressly stated
herein.

In addition to the foregoing, upon the request of Eleven, Roche shall, and shall
ensure that its Affiliates shall, and, to the extent Roche or any of its
Affiliates has the right to do so, shall require the other members of the Roche
Group to, complete, or promptly transition to Eleven or its designee, any
Clinical Studies related to the Returnable Product(s) that are being conducted
under any of their INDs for the Returnable Product(s) and are ongoing as of the
effective date of termination; provided, however, that
(i)
both Eleven and Roche in their reasonable judgment have concluded that
completing any such Clinical Studies does not present an unreasonable risk to
patient safety;

(ii)
Roche shall have no obligation to recruit or enroll any additional patients
after the effective date of termination; and

(iii)
Subject to Section 18.3.4.1(b), Eleven agrees to reimburse Roche for all of its
reasonable development costs that arise after the effective date of termination
in completing or transitioning such Clinical Studies.

18.3.4.2

Obligations Related to Manufacturing

a)
Clinical Supplies

If Eleven elects to develop the Returnable Product(s), Roche shall, at Eleven’s
request, transfer (i) all existing and available clinical material to Eleven at
a price of Roche’s fully burdened manufacturing cost and (ii) as part of the
Roche Transfer Activities of Section 18.3.2, all existing documentation as to
the quality of such clinical material that is reasonably required for further
development activities. Roche shall have no obligation to perform any additional
activities concerning the clinical supplies (e.g., retesting, analyses). Upon
request, Roche shall notify Eleven of any issues concerning such materials that
to Roche’s knowledge might reasonably subject Eleven to liability through use of
such materials, and Eleven may thereafter elect not to receive such materials.
Eleven shall assume all liability for the use of such transferred material.

b)
Commercial Supplies

If a Returnable Product is marketed in any country of Territory on the date of
the notice of termination of this Agreement, upon the request of Eleven, Roche
shall manufacture and supply such Returnable Product to Eleven for a period of
eighteen (18) months from the effective date of the termination of this
Agreement (unless such obligation is earlier terminated by Eleven) at a price of
one hundred twenty-five percent (125%) of Roche’s fully burdened manufacturing
cost. Eleven shall use Commercially Reasonable Efforts to take over the
manufacturing as soon as possible after the effective date of termination.

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c)
Option of Roche

Irrespective of the foregoing, Roche shall not be required to provide
Proprietary Manufacturing IP with respect to Early Returnable Products. Roche
will continue to supply Eleven with Returnable Products other than Early
Returnable Products at a price of one hundred twenty-five percent (125%) of
Roche’s fully burdened manufacturing cost for a period, at Roche’s election, of
either (i) indefinitely (in which case the Parties will promptly and in good
faith negotiate the non-financial terms of applicable supply and quality
agreements, and Roche shall make good faith efforts to supply Eleven with such
Returnable Products during such negotiation period) or (ii) until such time as
Roche transfers the process to a Third Party CMO acceptable to Roche under
conditions of confidentiality and non-use acceptable to Roche. If Roche elects
to transfer the process to a Third Party CMO and Eleven requests an additional
CMO be utilized (for reasons such as second source manufacturing, competitive
pricing), Roche will make good faith efforts to accommodate such request and
transfer the process to a second Third Party CMO acceptable to Roche under
conditions of confidentiality and non-use acceptable to Roche.
18.3.4.3

Limitations on Grant-Backs; Transfer Expenses

For purposes of clarity, irrespective of anything to the contrary in this
Agreement:

a)
All transfers and licenses from Roche to Eleven or other obligations of Roche
under Section 18.3 are solely with respect to Returnable Product(s) that are not
Combination Product(s). Such transfers, licenses and obligations do not extend
to

(i)
other therapeutically active ingredients or therapeutically active products,
even if physically mixed, combined or packaged together with a Returnable
Product, or

(ii)
with respect to Pre-Commercialized Returnable Products, delivery technologies
that are proprietary to Roche (through ownership or license) (with the proviso
that if Eleven would be unable to use any alternative delivery technology to
commercialize such Pre-Commercialized Returnable Product, Roche will in good
faith consider making such delivery technologies available to Eleven),

even if a Returnable Product is intended (according to the investigation plan,
proposed labeling or actual labeling, as applicable) for use with such other
therapeutically active ingredients, therapeutically active products, or delivery
technologies.

b)
In connection with research studies, clinical trials or other activities
associated with the development and commercialization of Returnable Products,
Roche or other members of the Roche Group may have collected human samples and
patient information that may contain personal identifiable information (“Samples
and PI Information”). Legal and contractual restrictions may apply to such
Samples and PI Information. Eleven acknowledges and accepts that, where Roche in
good faith has reasonable concerns that Applicable Law or insufficient patient
consent would prohibit the transfer of such Samples and PI Information or
subject Roche to liability because of such transfer and subsequent use by
Eleven, then Roche shall not be obliged to transfer such Samples and PI
Information to Eleven.

c)
Nothing in this Agreement shall be construed as granting Eleven any license
under the Excluded Roche Patent Rights.

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d)
If Eleven issues a Continuation Election Notice, then Eleven shall reimburse
Roche for all reasonable out-of-pocket costs and expenses (including FTE
charges) incurred by or on behalf of Roche for transfer activities from Roche to
Eleven under Section 18.3.2 (including costs associated with locating,
assembling and populating information into the data room) (“Roche Transfer
Activities”) within thirty (30) days after receipt of an invoice, with an
invoice to be provided no more than once per Calendar Quarter; however transfer
activities corresponding to the return of material remains, data, reports,
records, documents, regulatory filings and Regulatory Approvals originally
provided by Eleven to Roche no less than three (3) years prior to the effective
date of termination (“Eleven-Originated Transfer Activities”) shall be returned
to Eleven free of charge. If the Agreement was terminated due to a Voluntary
Termination and Eleven desires Roche Transfer Activities other than
Eleven-Originated Transfer Activities, Eleven shall make a payment to Roche of
Two Hundred Fifty Thousand US Dollars (US$ 250,000) (“Minimum Transfer Payment”)
within thirty (30) days after receipt of an invoice. The Minimum Transfer
Payment shall be non-refundable, but shall be fully creditable against Eleven’s
reimbursement for the Roche Transfer Activities and payments under
Section 18.3.2(d). Roche shall be under no obligation to provide Roche Transfer
Activities (beyond the Eleven-Originated Transfer Activities) prior to receipt
of the Minimum Transfer Payment, if applicable.

18.4

Royalty and Payment Obligations

Expiration or termination of this Agreement shall not release Roche from any
obligation to pay royalties or make any payments to Eleven that are earned but
not yet paid prior to the Expiration Date or effective date of termination,
including milestone payments on events, and royalties on Sales, that occur prior
to the Expiration Date or effective date of termination. Expiration of this
Agreement as a result of Roche exercising a Buy-out Option shall not release
Roche from the obligation to pay the fee associated with such Buy-out Option
under Section 9.4. Except as set forth in this Section 18.4, termination of this
Agreement by a Party, for any reason, will release Roche from any obligation to
pay royalties or make any payments to Eleven under Sections 9.2 or 9.3 that
would otherwise become payable on or after the effective date of termination
(including, for clarity, any milestone payments on events, or royalties on
Sales, that occur after the effective date of termination, but not prior to the
effective date of termination).

18.5

Survival

To the extent then in effect as set forth in Section 18.1, Article 1
(Definitions, to the extent necessary to interpret this Agreement), Section 9.5
(Disclosure of Payments), Article 10 (Accounting and Reporting) (solely as
applicable to amounts described in Section 18.4), Article 12 (Auditing),
Section 14.3 (No Other Representations), Article 15 (Indemnification),
Article 16 (Liability), Article 17 (Obligation Not to Disclose Confidential
Information), Article 18 (Agreement Expiration and Termination) and Article 21
(Miscellaneous) (except for Sections 21.4(a)-(c) (Assignment and Change of
Control)) shall survive any expiration or termination of this Agreement for any
reason. If Roche exercises a Buy-out Option, Section 9.4 (Buy-out Options),
Article 13 (Intellectual Property) and Article 20 (Bankruptcy) shall also
survive.

19.

Solicitation

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Except as otherwise set forth in Article 17 and in this Article 19, until the
earlier of the Effective Date and the termination of this Agreement in
accordance with Section 18.2.5, Eleven shall not, and shall use its reasonable
best efforts to cause its officers, directors, employees, investment bankers,
attorneys or other agents or advisors (collectively, “Representatives”) not to,
directly or indirectly:
(a)

solicit, initiate or knowingly facilitate or knowingly encourage the submission
of any proposal or offer from any Third Party for an Alternative Transaction;

(b)

enter into or participate in any discussions or negotiations with, furnish any
non-public information relating to the IL-6 program to, or afford access to the
business, properties, assets, books or records of the IL-6 program to, any Third
Party that, to Eleven’s knowledge, is seeking to make, or has made, any proposal
or offer for an Alternative Transaction, in each case relating to or in
connection with an Alternative Transaction; or

(c)

enter into any agreement with any person or entity (other than Roche) for an
Alternative Transaction.

Notwithstanding the foregoing, Eleven may: (i) furnish non-public information
relating to, and afford access to the business, properties, assets, books or
records of, the IL-6 program to any Qualified Person (and the Representatives of
any such Qualified Person), pursuant to a confidentiality agreement not
materially less restrictive of the other party than the confidentiality
obligations applicable to Roche pursuant to the NDA; (ii) engage in discussions
or negotiations (including solicitation of revised proposals with respect to an
Alternative Transaction) with any Qualified Person (and the representatives of
such Qualified Person) with respect to a potential Alternative Transaction;
(iii) amend or grant a waiver or release under, any standstill or similar
agreement with respect to any capital stock of Eleven with any Qualified Person;
or (iv) enter into an agreement with a Qualified Person with respect to an
Alternative Transaction.

20.

Bankruptcy

All licenses (and to the extent applicable rights) granted under or pursuant to
this Agreement by Eleven to Roche are, and shall otherwise be deemed to be, for
purposes of Section 365(n) of Title 11, US Code (the “Bankruptcy Code”) licenses
of rights to “intellectual property” as defined under Section 101(35A) of the
Bankruptcy Code. Unless Roche elects to terminate this Agreement, the Parties
agree that Roche, as a licensee or sublicensee of such rights under this
Agreement, shall retain and may fully exercise all of its rights and elections
under the Bankruptcy Code, subject to the continued performance of its
obligations under this Agreement.

21.

Miscellaneous

21.1

Governing Law

This Agreement shall be governed by and construed in accordance with the laws of
the state of Delaware, US, without reference to its conflict of laws principles.

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21.2

Disputes

After the Effective Date, unless otherwise set forth in this Agreement, in the
event of any dispute in connection with this Agreement, such dispute shall be
referred to the respective executive officers of the Parties designated below or
the Party’s designee, for good faith negotiations attempting to resolve the
dispute. The designated executive officers are as follows:
For Eleven:    CEO
For Roche:    Head of Roche Partnering

21.3

Jurisdiction; Arbitration

Prior to the Effective Date, each of the Parties (a) consents to submit itself
to the exclusive jurisdiction of the Court of Chancery of the State of Delaware
or, solely if such court lacks subject matter jurisdiction, United States
District Court sitting in Wilmington, Delaware, with respect to any action or
proceeding arising out of or relating to this Agreement or any of the
transactions contemplated by this Agreement, (b) agrees that all claims in
respect of such action or proceeding may be heard and determined in any such
court, (c) agrees that it shall not attempt to deny or defeat such personal
jurisdiction by motion or other request for leave from any such court and (d)
agrees not to bring any action or proceeding arising out of or relating to this
Agreement or any of the transactions contemplated by this Agreement in any other
court, and each Party hereby further irrevocably and unconditionally waives and
agrees not to plead or claim in any such court that any such legal proceeding
brought in any such court has been brought in an inconvenient forum. Each Party
hereby agrees that service of any process, summons, notice or document by U.S.
registered mail to the respective addresses set forth in Section 21.13 shall be
effective service of process.

After the Effective Date, should the Parties fail to agree within two (2) months
after a dispute in connection with this Agreement has first arisen, it shall be
finally settled by arbitration in accordance with the Rules of American
Arbitration Association (AAA) as in force at the time when initiating the
arbitration. The tribunal shall consist of three arbitrators. Each Party shall
select one (1) arbitrator and the arbitrators shall select the third arbitrator.
The place of arbitration shall be in the city of New York, New York, US. The
language to be used shall be English. Notwithstanding anything to the contrary
in this Agreement, a Party may seek temporary equitable relief in the form of
specific performance, a temporary restraining order, a preliminary injunction or
any other equitable remedy in any court of competent jurisdiction.

21.4

Assignment and Change of Control

Neither Party may assign its rights or obligations under this Agreement absent
the prior written consent of the other Party, except to any of its Affiliates
(provided that the assigning Party shall be responsible for the actions of its
Affiliates) or in the context of a merger, an acquisition, a Change of Control,
or a sale or other transaction involving all or substantially all of the assets
of the Party seeking to assign. Any permitted assignment shall be binding on the
successors of the assigning Party. Notwithstanding anything else herein to the
contrary, Eleven may, without Roche’s consent, assign, distribute, dividend or
otherwise transfer its right to receive payment(s) from Roche under all or part
of Article 9, provided, however, for clarity, Roche’s right to pursue reduction
of payments in the event of a material breach by Eleven shall not be impacted by
such assignment, distribution, dividend or transfer; moreover this

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right extends only to the right to receive payment, so all other rights
(including the right to audit) shall remain with Eleven absent Roche’s written
consent.

If there is a Change of Control, then the following provisions shall apply and
be in full force and effect:
(a)
Eleven shall provide written notice to Roche within fifteen (15) days after
completion of such Change of Control.

(b)
The acquirer of or the successor to in connection with such Change of Control
shall acknowledge in writing to Roche that the Eleven Know-How and the Primary
Eleven Patent Rights are subject to the exclusive licenses to Roche for the
research, development or commercialization of Compounds or Products, subject to
the terms and conditions of this Agreement.

(c)
If either Eleven or the Change of Control Group are engaged in the conduct of
clinical studies or commercialization of competing ophthalmic products either at
the time of the Change of Control or thereafter, then Roche may upon written
request require Eleven and the Change of Control Group to institute a firewall
to limit access of information and reports provided to Eleven by the Roche Group
under Article 8 and Article 13 (collectively “Sensitive Information”) to (1)
such Eleven and Change of Control Group personnel, attorneys, agents and
advisors that reasonably need access to and knowledge of such Sensitive
Information to perform Eleven’s obligations and exercise Eleven’s rights under
the Agreement and (2) C-level personnel of Eleven or the Change of Control
Group, with the objective to prohibit the use of such Sensitive Information by
Eleven or the Change of Control Group for competitive reasons that would be
detrimental to Roche’s interests under the Agreement or Licensed Compounds or
Licensed Products without foreclosing the ability of Eleven or the Change of
Control Group to perform Eleven’s obligations and exercise Eleven’s rights under
the Agreement. For clarity, (i) information about payments made by Roche under
this Agreement shall not be deemed as Sensitive Information that is subject to
the firewall of this Section 21.4(c), and (ii) the exceptions under Sections
1.21(i)-(v), 17.3 and 17.4 to Eleven’s obligations to protect Roche’s
Confidential Information shall also apply to Sensitive Information.

21.5

Debarment

Eleven represents and warrants that, as of the Signature Date, it has never been
debarred under 21 U.S.C. §335a, disqualified under 21 C.F.R. §312.70 or
§812.119, sanctioned by a Federal Health Care Program (as defined in 42 U.S.C.
§1320 a-7b(f)), including without limitation the federal Medicare or a state
Medicaid program, or debarred, suspended, excluded or otherwise declared
ineligible from any other similar Federal or state agency or program. In the
event Eleven receives notice of its debarment, suspension, sanction, exclusion,
ineligibility or disqualification under the above-referenced statutes, Eleven
shall immediately notify Roche in writing and Roche shall have the right, but
not the obligation, to terminate this Agreement, effective, at Roche’s option,
immediately or at a specified future date.

21.6

Independent Contractor

No employee or representative of either Party shall have any authority to bind
or obligate the other Party to this Agreement for any sum or in any manner
whatsoever or to create or impose any contractual or other liability on the
other Party without said Party's prior written approval. For all purposes, and
notwithstanding any other provision of this Agreement to the contrary, each
Party’s legal relationship to the other Party under this Agreement shall be that
of independent contractor, and nothing contained

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in this Agreement shall be deemed or construed to create a partnership, joint
venture, employment, franchise, agency or fiduciary relationship between the
Parties.

21.7

Unenforceable Provisions and Severability

If any of the provisions of this Agreement are held to be void or unenforceable,
then such void or unenforceable provisions shall be replaced by valid and
enforceable provisions that will achieve as far as possible the economic
business intentions of the Parties. However the remainder of this Agreement will
remain in full force and effect, provided that the material interests of the
Parties are not affected, i.e., the Parties would presumably have concluded this
Agreement without the unenforceable provisions.

21.8

Waiver

The failure by either Party to require strict performance or observance of any
obligation, term, provision or condition under this Agreement will neither
constitute a waiver thereof nor affect in any way the right of the respective
Party to require such performance or observance. The waiver by either Party of a
breach of any obligation, term, provision or condition hereunder shall not
constitute a waiver of any subsequent breach thereof or of any other obligation,
term, provision or condition.

21.9

Appendices

All Appendices to this Agreement shall form an integral part to this Agreement.

21.10

Entire Understanding

This Agreement, together with the Exclusivity Agreement, the MTA and the
Non-Disclosure Agreement by and between Eleven and Roche US effective June, 2015
(the “NDA”), contains the entire understanding between the Parties with respect
to the subject matter hereof and supersedes any and all prior agreements,
understandings and arrangements, whether written or oral. For clarity, after the
Effective Date, the treatment of Information related to Technology (as such
terms are defined in the NDA) or Eleven’s business or financial information
received by Roche or any of its Affiliates from Eleven under the NDA (the
“Eleven NDA Information”), and any Confidential Information (as such term is
defined in the MTA) of Eleven subject to the MTA (the “Eleven MTA Information”),
is superseded by the licenses and treatment of Confidential Information under
this Agreement. For clarity, the three-way confidentiality agreements among
(i) Eleven, Roche US and Symbiosis, effective January 25, 2016, (ii) Eleven,
Roche US and FujiFilm, effective January 25, 2016, and (iii) Eleven, Roche US
and BioAgilytix Labs, LLC, effective June 3, 2016, shall remain in effect.

21.11

Amendments

No amendments of the terms and conditions of this Agreement shall be binding
upon either Party hereto unless in writing and signed by both Parties.

21.12

Invoices

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All invoices that are required or permitted hereunder shall be in writing and
sent by Eleven to Roche at the following address or such other US address as
Roche may later provide, and referencing the name and date of this Agreement:

Hoffmann-La Roche Inc.
Suite 8
150 Clove Road
Little Falls, NJ 07424
Attn: Roche Partnering Legal Department

With copies to:        vfspecialhandling@gene.com

and to:                F. Hoffmann-La Roche Ltd
Kreditorenbuchhaltung
Grenzacherstrasse 124
4070 Basel
Switzerland
Attn: (name of a Roche contact at time of invoice, e.g. the Alliance Director)

21.13

Notice

All notices that are required or permitted hereunder shall be in writing and
sufficient if delivered personally, sent by facsimile (and promptly confirmed by
personal delivery, registered or certified mail or overnight courier), sent by
nationally recognized overnight courier or sent by registered or certified mail,
postage prepaid, return receipt requested, addressed as follows:

if to Eleven, to:

Eleven Biotherapeutics, Inc.
215 First Street, Suite 400
Cambridge, Massachusetts 02142
U.S.A.
Attn: Chief Executive Officer
Facsimile: +1 617-858-0911
 
 
if to Roche, to:
F. Hoffmann-La Roche Ltd
Grenzacherstrasse 124
4070 Basel
Switzerland
Attn: Legal Department
Facsimile No.: +41 61 688 13 96

and:
Hoffmann-La Roche Inc.
150 Clove Road
Suite 8
Little Falls, New Jersey 07424
U.S.A.
Attn. Corporate Secretary
Facsimile No.: +1 973 890-8433

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or to such other address as the Party to whom notice is to be given may have
furnished to the other Party in writing in accordance herewith.

21.14

Interpretation

a)

Each Party acknowledges that it has been advised by counsel during the course of
negotiation of this Agreement, and, therefore, that this Agreement shall be
interpreted without regard to any presumption or rule requiring construction
against the Party causing this Agreement to be drafted.

b)

The headings, captions and table of contents in this Agreement are for
convenience of reference only and shall not be considered in construing this
Agreement.

c)

In construing this Agreement, except where the context acquires otherwise,
(i) use of the singular includes the plural and vice versa; (ii) the words
“include” “including”, “includes” and “e.g.” means “including without
limitation”; (iii) the word “or” is used in the inclusive sense that is
typically associated with the phrase “and/or”; (iv) the words “herein,” “hereof”
and “hereunder,” and words of similar import, refer to this Agreement in its
entirety and not to any particular provision hereof; (v) the verb “will” shall
be construed to have the same meaning and effect as the word “shall”; (vi) use
of any gender includes any other gender; (vii) any reference to any law or
regulation includes any amendment or modification to such law or regulation and
shall be deemed also to refer to all rules and regulations promulgated
thereunder; (viii) references to a particular person or entity include such
person’s or entity’s successors and assigns to the extent not prohibited by this
Agreement; and (ix) a capitalized term not defined herein but reflecting a
different part of speech than a capitalized term which is defined herein shall
be interpreted in a correlative manner.

[Signature Page Follows]

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IN WITNESS WHEREOF, the Parties have entered into this Agreement as of the
Signature Date.

Eleven Biotherapeutics, Inc.

___/s/ Abbie Celniker___________
Name: Abbie Celniker
Title: Chief Executive Officer

F. Hoffmann-La Roche Ltd

/s/ Stefan Arnold______________
Name: Stefan Arnold
Title: Head Legal Pharma

/s/ Vikas Kabra________________
Name: Vikas Kabra
Title: Head of Transaction Excellence

Hoffmann-La Roche Inc.

___/s/ John P. Parise_________________
Name: John P. Parise
Title: Authorized Signatory

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

Appendix 1.30

Core Patent Rights

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Application No.
Status
Filing Date
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Application No.
Status
Filing Date
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Any patents issuing on such patent applications listed above, and further
including any patents and patent applications claiming priority from the patents
and patent applications listed above and any substitution, extension or
supplementary protection certificate, reissue, reexamination, renewal,
divisional, continuation or continuation-in-part of any of the foregoing.

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

Appendix 1.32
Sequence of Eleven Compounds

Description

Sequence
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Appendix 1.85

Excluded Roche Patent Rights

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

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

Appendix 6.1

Product Inventory

The following is a complete list the Inventory (other than intermediates, raw
materials and in-process research material) and Eleven Cell Line Materials under
the Control of Eleven as of the Signature Date, including where and under which
conditions each item is stored:

Item
Description
Amounts, format and storage place

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Appendix 6.2

Agreements with Third Parties

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of one page was omitted. [**]

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

Appendix 13.2

Select Non-Prosecution Patent Rights

[**]
Country
Application No.
Status
Filing Date
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]

Any patents issuing on such patent applications listed above, and further
including any patents and patent applications claiming priority from the patents
and patent applications listed above and any substitution, extension or
supplementary protection certificate, reissue, reexamination, renewal,
divisional, continuation or continuation-in-part of any of the foregoing.

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

Appendix 17.3

Form of Press Releases

[pages follow]

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

[ebiologoa06.jpg]

Eleven Biotherapeutics Announces Signing of Exclusive License Agreement
License to Roche Covers IL-6 Antagonist Antibody Technology, Including EBI-031
IND Submission [Announced Today/Planned for this Quarter]
Cambridge, MA – June [13], 2016 –Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a
biopharmaceutical company discovering and developing protein therapeutics to
treat diseases of the eye, today announced that it has entered into an exclusive
license agreement with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc.
(Roche) relating to Eleven’s Interleukin-6 (IL-6) technology. Under the terms of
the agreement, Eleven has agreed to grant an exclusive, worldwide license to
Roche to develop and commercialize EBI-031, a humanized monoclonal antibody that
potently binds IL-6 and inhibits all known forms of IL-6 cytokine signaling,
currently being developed for the potential treatment of ocular diseases, and
all other IL-6 antagonist antibody technology owned by Eleven.
Under the agreement, Eleven will be entitled to an upfront payment of $7.5
million, along with potential future milestone payments of up to $262.5 million.
The first potential future milestone payment is subject to the effectiveness of
an investigational new drug application (IND) for EBI-031. This first milestone
payment will equal $22.5 million if the IND becomes effective on or before
September 15, 2016 or $20.0 million if the IND becomes effective after September
15, 2016. In addition, Eleven could be entitled to receive royalties for net
sales of potential future products containing EBI-031 or any other potential
future products containing other Eleven IL-6 compounds. Effectiveness of the
license agreement is subject to approval of the license by holders of at least a
majority of the outstanding shares of Eleven’s common stock.
“We remain on track to make a planned submission of an IND for EBI-031 this
quarter/were pleased to announce submission of an IND for EBI-031 [today],”
said Abbie Celniker, Ph.D., President and Chief Executive Officer of Eleven
Biotherapeutics. “We are pleased to see Roche poised to further develop this
potent IL-6 blocker for the potential benefit of patients. As previously
announced, we also continue to evaluate additional strategic alternatives with a
goal to maximize shareholder value.”
About EBI-031
Eleven Biotherapeutics' most advanced preclinical product candidate is EBI-031
for treatment of diabetic macular edema, or DME, and uveitis. EBI-031 was
designed and engineered for intravitreal delivery using Eleven’s AMP-Rx
platform. EBI-031 is a potent blocker of both free IL-6 and IL-6 complexed to
the soluble IL-6 receptor (IL-6R). [Eleven is undertaking the necessary
manufacturing development work and nonclinical safety studies to support the
submission of an investigational new drug application, or IND, to the FDA in the
[first half of 2016] for the purpose of conducting clinical trials of EBI-031 in
DME and uveitis.]
About Eleven Biotherapeutics

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

[ebiologoa06.jpg]

Eleven Biotherapeutics, Inc. is a preclinical-stage biopharmaceutical company
with a proprietary protein engineering platform, called AMP-Rx, that it applies
to the discovery and development of protein therapeutics to treat diseases of
the eye. Eleven’s therapeutic approach is based on the role of cytokines in
diseases of the eye, the Company’s understanding of the structural biology of
cytokines and the Company’s ability to rationally design and engineer proteins
to modulate the effects of cytokines. Cytokines are cell signaling molecules
found in the body that can have important inflammatory effects. For more
information please refer to the Company's website www.elevenbio.com.
Important Information
The Company plans to file with the Securities and Exchange Commission (“SEC”)
and mail to its stockholders a proxy statement in connection with the
transactions contemplated by the license agreement. Additionally, the Company
will file other relevant materials with the SEC in connection with the
transactions contemplated by the license agreement. The proxy statement will
contain important information about the Company, the transactions contemplated
by the license agreement and related matters. Investors and security holders are
urged to read the proxy statement carefully when it is available before making
any voting or investment decision with respect to the proposed transactions
because they will contain important information about the proposed transactions.
Investors and security holders will be able to obtain free copies of the proxy
statement and other documents filed with the SEC by the Company through the web
site maintained by the SEC at www.sec.gov. In addition, investors and security
holders will be able to obtain free copies of the proxy statement from public
company by contacting Leah Monteiro at (617) 714-0619.
The Company and its directors and executive officers may be deemed to be
participants in the solicitation of proxies in respect of the transactions
contemplated by the license agreement. Information regarding the Company’s
directors and executive officers is contained in the Company’s Form 10-K for the
fiscal year ended December 31, 2015, and its proxy statement dated April 29,
2016, each of which has been filed with the SEC. Additional information
regarding the participants in the solicitation of proxies in respect of the
transactions contemplated by the license agreement and a description of their
direct and indirect interests, by security holdings or otherwise, will be
contained in the proxy statement and other relevant materials to be filed with
the SEC when they become available.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and
prospects for the Company, including statements about the potential
effectiveness of the license agreement or receipt of payments thereunder, the
future rights and obligations of the parties under the license agreement, the
Company's strategy, future operations, advancement or maturation of its product
candidates and product pipeline, clinical development of the Company's product
candidates, including expectations regarding timing of regulatory submissions
and initiation of clinical trials, regulatory requirements for initiation of
clinical trials and registration of product candidates, the review of its
strategic alternatives and the outcome of such review, the completion and
results of potential strategic transactions, the sufficiency of its cash
resources and other statements containing the words "anticipate," "believe,"
"estimate," "expect," "intend," "may," "plan," "predict," "project," "target,"
"potential," "will," "would," "could," "should," "continue," and

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

[ebiologoa06.jpg]

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: the occurrence of any event, change or
other circumstances that could give rise to the termination of the license
agreement, the outcome of any legal proceedings that could be instituted against
the Company or its directors related to the license agreement, the inability to
consummate the transactions contemplated by the license agreement due to the
failure to obtain the requisite approval of the Company’s stockholders, the
uncertainties inherent in the initiation and conduct of clinical trials,
availability and timing of data from clinical trials, whether results of early
clinical trials or preclinical studies will be indicative of the results of
future trials, the adequacy of any clinical models, uncertainties associated
with regulatory review of clinical trials and applications for marketing
approvals and other factors discussed in the "Risk Factors" section of the
Company's quarterly report on Form 10-Q for the quarter ended March 31, 2016 as
filed with the Securities and Exchange Commission and other reports on file with
the Securities and Exchange Commission. In addition, the forward-looking
statements included in this press release represent the Company's views as of
the date hereof. The Company anticipates that subsequent events and developments
will cause the Company's views to change. However, while the Company may elect
to update these forward-looking statements at some point in the future, the
Company specifically disclaims any obligation to do so. These forward-looking
statements should not be relied upon as representing the Company's views as of
any date subsequent to the date hereof.

Contacts:
Leah Monteiro
Eleven Biotherapeutics
Leah.Monteiro@elevenbio.com
617-714-0619

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

[ebiologoa06.jpg]

Eleven Biotherapeutics Announces Investigational New Drug Application Submission
to Initiate Clinical Trials of EBI-031 for Ocular Diseases
Cambridge, MA – June [13], 2016 – Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a
biopharmaceutical company discovering and developing protein therapeutics to
treat diseases of the eye, today announced that it has submitted an
Investigational New Drug (IND) application to the U.S. Food and Drug
Administration (FDA) to initiate a Phase 1 clinical trial of EBI-031, a
humanized monoclonal antibody that potently binds interleukin-6 (IL-6) and
inhibits all known forms of IL-6 cytokine signaling, which may be effective for
the treatment of ocular diseases such as diabetic macular edema and uveitis.
[Today/On June XX, 2016] Eleven announced that it had entered into an exclusive
license agreement with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc.
(Roche) for the further development and commercialization of EBI-031 and all
other IL-6 antagonist antibody technology owned by Eleven. Under the terms of
the agreement, Eleven could receive up to $262.5 million upon the achievement of
certain regulatory, development and commercialization milestones. The first
potential future milestone payment is subject to the effectiveness of the IND
for EBI-031. This first milestone payment will equal $22.5 million if the IND
becomes effective on or before September 15, 2016 or $20.0 million if the IND
becomes effective after September 15, 2016. In addition, Eleven could be
entitled to receive royalties for net sales of potential future products
containing EBI-031 or any other potential future products containing other
Eleven IL-6 compounds. Effectiveness of the license agreement is subject to
approval of the license by holders of at least a majority of the outstanding
shares of Eleven’s common stock.]
“We are pleased to have this IND under review by the FDA,” said Abbie Celniker,
Ph.D., President and Chief Executive Officer of Eleven Biotherapeutics. [“We
look forward to providing additional details on the development of EBI-031 as a
potential treatment for ocular diseases of the eye, such as diabetic macular
edema and uveitis, as they become available.”]
About EBI-031
Eleven Biotherapeutics' most advanced preclinical product candidate is EBI-031
for treatment of diabetic macular edema, or DME, and uveitis. EBI-031 was
designed and engineered for intravitreal delivery using Eleven’s AMP-Rx
platform. EBI-031 is a potent blocker of both free IL-6 and IL-6 complexed to
the soluble IL-6 receptor (IL-6R).
About Eleven Biotherapeutics
Eleven Biotherapeutics, Inc. is a preclinical-stage biopharmaceutical company
with a proprietary protein engineering platform, called AMP-Rx, that it applies
to the discovery and development of protein therapeutics to treat diseases of
the eye. Eleven’s therapeutic approach is based on the role of cytokines in
diseases of the eye, the Company’s understanding of the structural biology of
cytokines and the Company’s ability to rationally design and engineer proteins
to modulate the

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

[ebiologoa06.jpg]

effects of cytokines. Cytokines are cell signaling molecules found in the body
that can have important inflammatory effects. For more information please refer
to the Company's website www.elevenbio.com.
[Important Information
The Company plans to file with the Securities and Exchange Commission (“SEC”)
and mail to its stockholders a proxy statement in connection with the
transactions contemplated by the license agreement. Additionally, the Company
will file other relevant materials with the SEC in connection with the
transactions contemplated by the license agreement. The proxy statement will
contain important information about the Company, the transactions contemplated
by the license agreement and related matters. Investors and security holders are
urged to read the proxy statement carefully when it is available before making
any voting or investment decision with respect to the proposed transactions
because they will contain important information about the proposed transactions.
Investors and security holders will be able to obtain free copies of the proxy
statement and other documents filed with the SEC by the Company through the web
site maintained by the SEC at www.sec.gov. In addition, investors and security
holders will be able to obtain free copies of the proxy statement from public
company by contacting Leah Monteiro at (617) 714-0619.
The Company and its directors and executive officers may be deemed to be
participants in the solicitation of proxies in respect of the transactions
contemplated by the license agreement. Information regarding the Company’s
directors and executive officers is contained in the Company’s Form 10-K for the
fiscal year ended December 31, 2015, and its proxy statement dated April 29,
2016, each of which has been filed with the SEC. Additional information
regarding the participants in the solicitation of proxies in respect of the
transactions contemplated by the license agreement and a description of their
direct and indirect interests, by security holdings or otherwise, will be
contained in the proxy statement and other relevant materials to be filed with
the SEC when they become available.]
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and
prospects for the Company, including statements about the [potential
effectiveness of the license agreement or receipt of payments thereunder, the
future rights and obligations of the parties under the license agreement, the]
Company's strategy, future operations, advancement or maturation of its product
candidates and product pipeline, clinical development of the Company's product
candidates, including expectations regarding timing of regulatory submissions
and initiation of clinical trials, regulatory requirements for initiation of
clinical trials and registration of product candidates, the review of its
strategic alternatives and the outcome of such review, the completion and
results of potential strategic transactions, the sufficiency of its cash
resources 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: [the occurrence of any event, change or
other circumstances that could give rise to the termination of the license
agreement, the outcome of any legal proceedings that could be instituted against
the

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

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Company or its directors related to the license agreement, the inability to
consummate the transactions contemplated by the license agreement due to the
failure to obtain the requisite approval of the Company’s stockholders,] the
uncertainties inherent in the initiation and conduct of clinical trials,
availability and timing of data from clinical trials, whether results of early
clinical trials or preclinical studies will be indicative of the results of
future trials, the adequacy of any clinical models, uncertainties associated
with regulatory review of clinical trials and applications for marketing
approvals and other factors discussed in the "Risk Factors" section of the
Company's quarterly report on Form 10-Q for the quarter ended March 31, 2016 as
filed with the Securities and Exchange Commission and other reports on file with
the Securities and Exchange Commission. In addition, the forward-looking
statements included in this press release represent the Company's views as of
the date hereof. The Company anticipates that subsequent events and developments
will cause the Company's views to change. However, while the Company may elect
to update these forward-looking statements at some point in the future, the
Company specifically disclaims any obligation to do so. These forward-looking
statements should not be relied upon as representing the Company's views as of
any date subsequent to the date hereof.

Contact:

Leah Monteiro
Eleven Biotherapeutics
Leah.Monteiro@elevenbio.com
617-714-0619

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

[ebiologoa06.jpg]

Eleven Biotherapeutics Announces Effectiveness of Investigational New Drug
Application for EBI-031
Eleven entitled to receive [$22.5] million milestone payment for IND
effectiveness
Cambridge, MA – July XX, 2016 – Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a
biopharmaceutical company discovering and developing protein therapeutics to
treat diseases of the eye, today announced that the company’s Investigational
New Drug (IND) application for EBI-031, a humanized monoclonal antibody that
potently binds interleukin-6 (IL-6) and inhibits all known forms of IL-6
cytokine signaling, for treatment of ocular diseases, has become effective. As a
result of the achievement of this milestone, Eleven is entitled to receive a
[$22.5] million payment from F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche
Inc. (Roche) pursuant to the terms of its license agreement with Roche.
On June [13], 2016, Eleven announced that it had entered into an exclusive
license agreement with Roche for the further development and commercialization
of EBI-031 and all other IL-6 antagonist antibody technology owned by Eleven.
Under the terms of the agreement, Eleven could receive up to $262.5 million upon
the achievement of certain regulatory, development and commercialization
milestones, including this $22.5 million payment upon the effectiveness of the
IND for EBI-031. In addition, Eleven could be entitled to receive royalties for
net sales of potential future products containing EBI-031 or any other potential
future products containing other Eleven IL-6 compounds. [Effectiveness of the
license agreement, including Roche’s obligation to make the $22.5 million
milestone payment, is subject to approval of the license by holders of at least
a majority of the outstanding shares of Eleven’s common stock. OR The license
agreement became effective on XX 2016 subsequent to the approval of the license
by a majority vote of the holders of the outstanding shares of Eleven’s common
stock.]
“We look forward to Roche advancing EBI-031 into the clinic to explore its
potential use for ocular diseases, such as diabetic macular edema, in an effort
to bring this potential treatment to patients,” said Abbie Celniker, Ph.D.,
President and Chief Executive Officer of Eleven Biotherapeutics.
About EBI-031
Eleven Biotherapeutics' most advanced preclinical product candidate is EBI-031
for treatment of diabetic macular edema, or DME, and uveitis. EBI-031 was
designed and engineered for intravitreal delivery using Eleven’s AMP-Rx
platform. EBI-031 is a potent blocker of both free IL-6 and IL-6 complexed to
the soluble IL-6 receptor (IL-6R). Eleven filed an IND with the FDA in June 2016
for the purpose of conducting clinical trials of EBI-031 in DME and uveitis.
About Eleven Biotherapeutics
Eleven Biotherapeutics, Inc. is a preclinical-stage biopharmaceutical company
with a proprietary protein engineering platform, called AMP-Rx, that it applies
to the discovery and development of protein therapeutics to treat diseases of
the eye. Eleven’s therapeutic approach is based on the

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

[ebiologoa06.jpg]

role of cytokines in diseases of the eye, the Company’s understanding of the
structural biology of cytokines and the Company’s ability to rationally design
and engineer proteins to modulate the effects of cytokines. Cytokines are cell
signaling molecules found in the body that can have important inflammatory
effects. For more information please refer to the Company's website
www.elevenbio.com.
Important Information
The Company plans to file with the Securities and Exchange Commission (“SEC”)
and mail to its stockholders a proxy statement in connection with the
transactions contemplated by the license agreement. Additionally, the Company
will file other relevant materials with the SEC in connection with the
transactions contemplated by the license agreement. The proxy statement will
contain important information about the Company, the transactions contemplated
by the license agreement and related matters. Investors and security holders are
urged to read the proxy statement carefully when it is available before making
any voting or investment decision with respect to the proposed transactions
because they will contain important information about the proposed transactions.
Investors and security holders will be able to obtain free copies of the proxy
statement and other documents filed with the SEC by the Company through the web
site maintained by the SEC at www.sec.gov. In addition, investors and security
holders will be able to obtain free copies of the proxy statement from public
company by contacting Leah Monteiro at (617) 714-0619.
The Company and its directors and executive officers may be deemed to be
participants in the solicitation of proxies in respect of the transactions
contemplated by the license agreement. Information regarding the Company’s
directors and executive officers is contained in the Company’s Form 10-K for the
fiscal year ended December 31, 2015, and its proxy statement dated April 29,
2016, each of which has been filed with the SEC. Additional information
regarding the participants in the solicitation of proxies in respect of the
transactions contemplated by the license agreement and a description of their
direct and indirect interests, by security holdings or otherwise, will be
contained in the proxy statement and other relevant materials to be filed with
the SEC when they become available.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and
prospects for the Company, including statements about the potential
effectiveness of the license agreement or receipt of payments thereunder, the
future rights and obligations of the parties under the license agreement, the
Company's strategy, future operations, advancement or maturation of its product
candidates and product pipeline, clinical development of the Company's product
candidates, including expectations regarding timing of regulatory submissions
and initiation of clinical trials, regulatory requirements for initiation of
clinical trials and registration of product candidates, the review of its
strategic alternatives and the outcome of such review, the completion and
results of potential strategic transactions, the sufficiency of its cash
resources 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: the

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

[ebiologoa06.jpg]

occurrence of any event, change or other circumstances that could give rise to
the termination of the license agreement, the outcome of any legal proceedings
that could be instituted against the Company or its directors related to the
license agreement, the inability to consummate the transactions contemplated by
the license agreement due to the failure to obtain the requisite approval of the
Company’s stockholders, the uncertainties inherent in the initiation and conduct
of clinical trials, availability and timing of data from clinical trials,
whether results of early clinical trials or preclinical studies will be
indicative of the results of future trials, the adequacy of any clinical models,
uncertainties associated with regulatory review of clinical trials and
applications for marketing approvals and other factors discussed in the "Risk
Factors" section of the Company's quarterly report on Form 10-Q for the quarter
ended March 31, 2016 as filed with the Securities and Exchange Commission and
other reports on file with the Securities and Exchange Commission. In addition,
the forward-looking statements included in this press release represent the
Company's views as of the date hereof. The Company anticipates that subsequent
events and developments will cause the Company's views to change. However, while
the Company may elect to update these forward-looking statements at some point
in the future, the Company specifically disclaims any obligation to do so. These
forward-looking statements should not be relied upon as representing the
Company's views as of any date subsequent to the date hereof.

Contact:
Leah Monteiro
Eleven Biotherapeutics
Leah.Monteiro@elevenbio.com
617-714-0619

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

[ebiologoa06.jpg]

Eleven Biotherapeutics Announces Effectiveness of Investigational New Drug
Application for EBI-031
Eleven entitled to receive $20 million milestone payment for IND effectiveness
Cambridge, MA – Month/Day TBD, 2016 – Eleven Biotherapeutics, Inc. (NASDAQ:
EBIO), a biopharmaceutical company discovering and developing protein
therapeutics to treat diseases of the eye, today announced that the company’s
Investigational New Drug (IND) application for EBI-031, a humanized monoclonal
antibody that potently binds interleukin-6 (IL-6) and inhibits all known forms
of IL-6 cytokine signaling, for treatment of ocular diseases, has become
effective. As a result of the achievement of this milestone, Eleven is entitled
to receive a $20 million payment from F. Hoffmann-La Roche Ltd. and Hoffmann-La
Roche Inc. (Roche) pursuant to the terms of its license agreement with Roche.
On June [13], 2016, Eleven announced that it had entered into an exclusive
license agreement with Roche for the further development and commercialization
of EBI-031 and all other IL-6 antagonist antibody technology owned by Eleven.
[The license agreement became effective on XX, 2016 following the approval of
the transaction by a majority vote of holders of the outstanding shares of
Eleven’s common stock.] Under the terms of the agreement, Eleven could receive
up to $260 million upon the achievement of certain regulatory, development and
commercialization milestones, including this $20 million payment upon the
effectiveness of the IND for EBI-031. In addition, Eleven could be entitled to
receive royalties for net sales of potential future products containing EBI-031
or any other potential future products containing other Eleven IL-6 compounds.
[Effectiveness of the license agreement, including Roche’s obligation to make
the $20 million milestone payment, is subject to approval of the license by
holders of at least a majority of the outstanding shares of Eleven’s common
stock]
“We look forward to Roche advancing EBI-031 into the clinic to explore its
potential use for ocular diseases, such as diabetic macular edema, in an effort
to bring this potential treatment to patients,” said Abbie Celniker, Ph.D.,
President and Chief Executive Officer of Eleven Biotherapeutics.
About EBI-031
Eleven Biotherapeutics' most advanced preclinical product candidate is EBI-031
for treatment of diabetic macular edema, or DME, and uveitis. EBI-031 was
designed and engineered for intravitreal delivery using Eleven’s AMP-Rx
platform. EBI-031 is a potent blocker of both free IL-6 and IL-6 complexed to
the soluble IL-6 receptor (IL-6R). Eleven filed an IND with the FDA in June 2016
for the purpose of conducting clinical trials of EBI-031 in DME and uveitis.
About Eleven Biotherapeutics
Eleven Biotherapeutics, Inc. is a preclinical-stage biopharmaceutical company
with a proprietary protein engineering platform, called AMP-Rx, that it applies
to the discovery and development of protein therapeutics to treat diseases of
the eye. Eleven’s therapeutic approach is based on the

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

[ebiologoa06.jpg]

role of cytokines in diseases of the eye, the Company’s understanding of the
structural biology of cytokines and the Company’s ability to rationally design
and engineer proteins to modulate the effects of cytokines. Cytokines are cell
signaling molecules found in the body that can have important inflammatory
effects. For more information please refer to the Company's website
www.elevenbio.com.
Important Information
The Company plans to file with the Securities and Exchange Commission (“SEC”)
and mail to its stockholders a proxy statement in connection with the
transactions contemplated by the license agreement. Additionally, the Company
will file other relevant materials with the SEC in connection with the
transactions contemplated by the license agreement. The proxy statement will
contain important information about the Company, the transactions contemplated
by the license agreement and related matters. Investors and security holders are
urged to read the proxy statement carefully when it is available before making
any voting or investment decision with respect to the proposed transactions
because they will contain important information about the proposed transactions.
Investors and security holders will be able to obtain free copies of the proxy
statement and other documents filed with the SEC by the Company through the web
site maintained by the SEC at www.sec.gov. In addition, investors and security
holders will be able to obtain free copies of the proxy statement from public
company by contacting Leah Monteiro at (617) 714-0619.
The Company and its directors and executive officers may be deemed to be
participants in the solicitation of proxies in respect of the transactions
contemplated by the license agreement. Information regarding the Company’s
directors and executive officers is contained in the Company’s Form 10-K for the
fiscal year ended December 31, 2015, and its proxy statement dated April 29,
2016, each of which has been filed with the SEC. Additional information
regarding the participants in the solicitation of proxies in respect of the
transactions contemplated by the license agreement and a description of their
direct and indirect interests, by security holdings or otherwise, will be
contained in the proxy statement and other relevant materials to be filed with
the SEC when they become available.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and
prospects for the Company, including statements about the potential
effectiveness of the license agreement or receipt of payments thereunder, the
future rights and obligations of the parties under the license agreement, the
Company's strategy, future operations, advancement or maturation of its product
candidates and product pipeline, clinical development of the Company's product
candidates, including expectations regarding timing of regulatory submissions
and initiation of clinical trials, regulatory requirements for initiation of
clinical trials and registration of product candidates, the review of its
strategic alternatives and the outcome of such review, the completion and
results of potential strategic transactions, the sufficiency of its cash
resources 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: the

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

[ebiologoa06.jpg]

occurrence of any event, change or other circumstances that could give rise to
the termination of the license agreement, the outcome of any legal proceedings
that could be instituted against the Company or its directors related to the
license agreement, the inability to consummate the transactions contemplated by
the license agreement due to the failure to obtain the requisite approval of the
Company’s stockholders, the uncertainties inherent in the initiation and conduct
of clinical trials, availability and timing of data from clinical trials,
whether results of early clinical trials or preclinical studies will be
indicative of the results of future trials, the adequacy of any clinical models,
uncertainties associated with regulatory review of clinical trials and
applications for marketing approvals and other factors discussed in the "Risk
Factors" section of the Company's quarterly report on Form 10-Q for the quarter
ended March 31, 2016 as filed with the Securities and Exchange Commission and
other reports on file with the Securities and Exchange Commission. In addition,
the forward-looking statements included in this press release represent the
Company's views as of the date hereof. The Company anticipates that subsequent
events and developments will cause the Company's views to change. However, while
the Company may elect to update these forward-looking statements at some point
in the future, the Company specifically disclaims any obligation to do so. These
forward-looking statements should not be relied upon as representing the
Company's views as of any date subsequent to the date hereof.

Contact:
Leah Monteiro
Eleven Biotherapeutics
Leah.Monteiro@elevenbio.com
617-714-0619

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

[ebiologoa06.jpg]

Eleven Biotherapeutics Completes Exclusive Licensing Deal for IL-6 Antagonist
Antibody Technology, Including EBI-031
Eleven entitled to $[7.5][30] million payment
Cambridge, MA – July XX, 2016 – Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a
biopharmaceutical company discovering and developing protein therapeutics to
treat diseases of the eye, today announced the effectiveness of the exclusive
licensing deal with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc.
(Roche), pursuant to which Eleven has granted Roche an exclusive, worldwide
license to develop and commercialize EBI-031, a humanized monoclonal antibody
that potently binds interleukin-6 (IL-6) and inhibits all known forms of IL-6
cytokine signaling, currently being developed for the treatment of ocular
diseases, and all other IL-6 antagonist antibody technology owned by Eleven. In
connection with the effectiveness of the license agreement, Eleven is entitled
to an upfront payment of $7.5 million.
[On June XX, 2016 Eleven Biotherapeutics announced submission of an
investigational new drug application (IND) for EBI-031 to the FDA and is
awaiting clearance. Upon effectiveness of the IND, Eleven will be entitled to an
additional $22.5 million if the IND becomes effective on or before September 15,
2016 or $20.0 million if the IND becomes effective after September 15, 2016.] OR
[On July [XX], 2016, the Investigational New Drug (IND) application for EBI-031
became effective. As a result of the achievement of this milestone, Eleven is
entitled to receive an additional $22.5 million payment from Roche pursuant to
the terms of the license agreement.] Under the terms of the agreement, Eleven
could receive up to an additional $240 million upon the achievement of certain
future regulatory, development and commercialization milestones. In addition,
Eleven could be entitled to receive royalties for net sales of potential future
products containing EBI-031 or any other potential future products containing
other Eleven IL-6 compounds.
“This is an important milestone in the development of EBI-031 and we look
forward to the advancement by Roche of EBI-031 into the clinic to explore its
potential use for ocular diseases, such as diabetic macular edema,” said Abbie
Celniker, Ph.D., President and Chief Executive Officer of Eleven
Biotherapeutics.
About EBI-031
Eleven Biotherapeutics' most advanced preclinical product candidate is EBI-031
for treatment of diabetic macular edema, or DME, and uveitis. EBI-031 was
designed and engineered for intravitreal delivery using Eleven’s AMP-Rx
platform. EBI-031 is a potent blocker of both free IL-6 and IL-6 complexed to
the soluble IL-6 receptor (IL-6R). Eleven filed an IND with the FDA in June 2016
[and received clearance in XXX 2016] for the purpose of conducting clinical
trials of EBI-031 in DME and uveitis.
About Eleven Biotherapeutics

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

[ebiologoa06.jpg]

Eleven Biotherapeutics, Inc. is a preclinical-stage biopharmaceutical company
with a proprietary protein engineering platform, called AMP-Rx, that it applies
to the discovery and development of protein therapeutics to treat diseases of
the eye. Eleven’s therapeutic approach is based on the role of cytokines in
diseases of the eye, the Company’s understanding of the structural biology of
cytokines and the Company’s ability to rationally design and engineer proteins
to modulate the effects of cytokines. Cytokines are cell signaling molecules
found in the body that can have important inflammatory effects. For more
information please refer to the Company's website www.elevenbio.com.
Important Information
The Company plans to file with the Securities and Exchange Commission (“SEC”)
and mail to its stockholders a proxy statement in connection with the
transactions contemplated by the license agreement. Additionally, the Company
will file other relevant materials with the SEC in connection with the
transactions contemplated by the license agreement. The proxy statement will
contain important information about the Company, the transactions contemplated
by the license agreement and related matters. Investors and security holders are
urged to read the proxy statement carefully when it is available before making
any voting or investment decision with respect to the proposed transactions
because they will contain important information about the proposed transactions.
Investors and security holders will be able to obtain free copies of the proxy
statement and other documents filed with the SEC by the Company through the web
site maintained by the SEC at www.sec.gov. In addition, investors and security
holders will be able to obtain free copies of the proxy statement from public
company by contacting Leah Monteiro at (617) 714-0619.
The Company and its directors and executive officers may be deemed to be
participants in the solicitation of proxies in respect of the transactions
contemplated by the license agreement. Information regarding the Company’s
directors and executive officers is contained in the Company’s Form 10-K for the
fiscal year ended December 31, 2015, and its proxy statement dated April 29,
2016, each of which has been filed with the SEC. Additional information
regarding the participants in the solicitation of proxies in respect of the
transactions contemplated by the license agreement and a description of their
direct and indirect interests, by security holdings or otherwise, will be
contained in the proxy statement and other relevant materials to be filed with
the SEC when they become available.
Cautionary Note on Forward-Looking Statements
Any statements in this press release about future expectations, plans and
prospects for the Company, including statements about the potential
effectiveness of the license agreement or receipt of payments thereunder, the
future rights and obligations of the parties under the license agreement, the
Company's strategy, future operations, advancement or maturation of its product
candidates and product pipeline, clinical development of the Company's product
candidates, including expectations regarding timing of regulatory submissions
and initiation of clinical trials, regulatory requirements for initiation of
clinical trials and registration of product candidates, the review of its
strategic alternatives and the outcome of such review, [the results of strategic
transactions], the sufficiency of its cash resources 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

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

[ebiologoa06.jpg]

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: the occurrence of any event, change or other circumstances
that could give rise to the termination of the license agreement, the outcome of
any legal proceedings that could be instituted against the Company or its
directors related to the license agreement, the inability to consummate the
transactions contemplated by the license agreement due to the failure to obtain
the requisite approval of the Company’s stockholders, the uncertainties inherent
in the initiation and conduct of clinical trials, availability and timing of
data from clinical trials, whether results of early clinical trials or
preclinical studies will be indicative of the results of future trials, the
adequacy of any clinical models, uncertainties associated with regulatory review
of clinical trials and applications for marketing approvals and other factors
discussed in the "Risk Factors" section of the Company's quarterly report on
Form 10-Q for the quarter ended March 31, 2016 as filed with the Securities and
Exchange Commission and other reports on file with the Securities and Exchange
Commission. In addition, the forward-looking statements included in this press
release represent the Company's views as of the date hereof. The Company
anticipates that subsequent events and developments will cause the Company's
views to change. However, while the Company may elect to update these
forward-looking statements at some point in the future, the Company specifically
disclaims any obligation to do so. These forward-looking statements should not
be relied upon as representing the Company's views as of any date subsequent to
the date hereof.

Contact:
Leah Monteiro
Eleven Biotherapeutics
Leah.Monteiro@elevenbio.com
617-714-0619