Exhibit 10.1

Execution Copy

COLLABORATION AND OPTION AGREEMENT

between

IMMUNOGEN, INC.

and

JAZZ PHARMACEUTICALS IRELAND LIMITED

dated

August 28, 2017

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Table of Contents

 

 

 

 

 

Page

 

 

ARTICLE I DEFINITIONS

1

ARTICLE II COLLABORATION MANAGEMENT

24

2.1

Alliance Management

24

2.2

Joint Steering Committee

25

2.3

Joint Research and Development Committee

27

2.4

Committee Consolidation with License Agreement(s)

30

ARTICLE III OVERVIEW; RESEARCH PROGRAMS

30

3.1

Overview

30

3.2

Early Research Programs

30

3.3

Candidate Research Programs

31

3.4

Selection of New Product

32

3.5

Back-Up Candidates

33

ARTICLE IV OPTION RIGHTS

34

4.1

Option Grant

34

4.2

Jazz Option Period

35

4.3

Provision of Data Package

36

4.4

Option Exercise

37

4.5

Expiration of Jazz Late Stage Options

38

4.6

[***]

38

ARTICLE V DEVELOPMENT AND MANUFACTURING

39

5.1

Development of Collaboration Products

39

5.2

[***]

43

5.3

[***]

44

5.4

Manufacturing; Supply of Materials

45

5.5

Exclusivity

46

5.6

ImmunoGen Opt-In

48

5.7

Burdened Technology

48

ARTICLE VI FINANCIAL TERMS

49

6.1

Upfront Fee

49

6.2

Research and Development Funding

49

 

-ii-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Table of Contents

(continued)

56

 

 

 

 

Page

 

 

 

6.3

Payment Terms

53

6.4

Overdue Payments

54

6.5

Records Retention; Audit

54

ARTICLE VII TREATMENT OF CONFIDENTIAL INFORMATION

56

7.1

Confidentiality

56

7.2

Publicity

57

7.3

Publications and Presentations

59

7.4

Integration

60

ARTICLE VIII INTELLECTUAL PROPERTY

60

8.1

Ownership of Intellectual Property; License

60

8.2

Patent Filing, Prosecution and Maintenance

61

8.3

Bankruptcy

61

ARTICLE IX TERM AND TERMINATION

61

9.1

Term

62

9.2

Termination

62

9.3

Consequences of Expiration or Termination

63

9.4

Surviving Provisions

64

ARTICLE X IMMUNOGEN PRODUCTS

64

10.1

Additional Definitions

64

10.2

Responsibility and Authority

69

10.3

Payment of Royalties; ImmunoGen Royalty Term

70

10.4

Payment of Royalties

71

10.5

Generic Competition

72

10.6

Accounting

72

10.7

No Set-Off; Tax Withholding

72

10.8

Wire Transfers

73

10.9

Overdue Payments

73

10.10

Records Retention; Audit

73

ARTICLE XI REPRESENTATIONS AND WARRANTIES

75

11.1

ImmunoGen Representations

75

-iii-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Table of Contents
(continued)

 

 

 

 

 

Page

 

 

 

11.2

Additional Representations and Warranties of ImmunoGen

76

11.3

Jazz Representations

78

11.4

Warranty Disclaimers

78

11.5

Covenants

79

11.6

Anti-Corruption Laws

80

ARTICLE XII INDEMNIFICATION; LIABILITY

80

12.1

Indemnification

80

12.2

Procedure

82

12.3

Insurance

83

12.4

Limited Liability

83

ARTICLE XIII MISCELLANEOUS

84

13.1

Notices

84

13.2

Governing Law

85

13.3

Entire Agreement

85

13.4

Amendment and Waiver

85

13.5

Binding Effect

85

13.6

Purpose and Scope

85

13.7

Headings

86

13.8

Assignment

86

13.9

Performance by Affiliates

86

13.10

Force Majeure

86

13.11

Interpretation

87

13.12

Severability

87

13.13

Dispute Resolution

87

13.14

Interim Equitable Relief

90

13.15

Prohibition on Hiring; Solicitation

90

13.16

Further Assurances

90

13.17

Execution

90

 

 

-iv-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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COLLABORATION AND OPTION AGREEMENT

This Collaboration and Option Agreement (this “Agreement”) is made effective as
of August 28, 2017 (the “Effective Date”) by and between ImmunoGen, Inc., a
Massachusetts corporation (“ImmunoGen”), with its principal place of business at
830 Winter Street, Waltham, Massachusetts 02451, and Jazz Pharmaceuticals
Ireland Limited, a corporation organized under the laws of Ireland (“Jazz”),
with its principal place of business at Waterloo Exchange, Waterloo Road, Dublin
4, Ireland. ImmunoGen and Jazz are sometimes each hereinafter referred to
individually as a “Party” and collectively as the “Parties.”

WHEREAS, ImmunoGen is the owner of or otherwise controls certain rights in
Technology relating to antibody-drug conjugates;

WHEREAS, Jazz has extensive experience and expertise in the development and
commercialization of biopharmaceutical products;

WHEREAS, pursuant to the terms and conditions set forth herein, ImmunoGen and
Jazz desire to collaborate in the research and development of Collaboration
Products (as defined below); and

WHEREAS, pursuant to the terms and conditions set forth herein, ImmunoGen
desires to grant to Jazz, and Jazz wishes to receive from ImmunoGen, an option
to take an exclusive, worldwide license to develop and commercialize
Collaboration Products;

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

ARTICLE I
DEFINITIONS

Whenever used in this Agreement with an initial capital letter, the terms
defined in this Article I have the meanings specified.

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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1.1       “ADC” means any compound that incorporates, is comprised of, or is
otherwise derived from, a conjugate of an Antibody with a Cytotoxic Compound,
whether with or without a Linker.

1.2       “ADC Platform Improvement” means any enhancement, improvement, or
modification (each, an “Improvement”) to the following Technology Controlled by
ImmunoGen: (a) the [***] of [***] or [***], (b) [***] of [***] or [***], (c) the
[***] for [***] (including [***] or [***] that create improvements in [***] of
such [***]), (d) the [***] for [***] or [***] any [***] or [***], or (e) the
[***] of [***], in each case of (a)–(e), [***] such [***] or [***] is (i) [***]
during [***] or (ii) [***] in its [***] or [***] of [***] under this Agreement
and [***] under this Agreement.

1.3       “Affiliate” means, with respect to any Person, any other Person that,
directly or indirectly through one or more Affiliates, controls or is controlled
by or is under common control with such Person. For purposes of this definition,
“control” means (a) ownership of fifty percent (50%) or more of the shares of
stock entitled to vote for the election of directors, in the case of a
corporation, or fifty percent (50%) or more of the equity interests in the case
of any other type of legal entity, (b) status as a general partner in the case
of any partnership, or (c) any other arrangement whereby a Person controls or
has the right to control the board of directors or equivalent governing body or
management of another Person. A Person shall be deemed an Affiliate only so long
as it satisfies the foregoing definition.

1.4       “AML” means Acute Myeloid Leukemia.

1.5       “Antibody” means a polypeptide that Targets an antigen, which
polypeptide comprises: (a) one or more immunoglobulin variable domains; (b) one
or more fragments, variants, modifications or derivatives of such immunoglobulin
variable domains irrespective of origin or source, including antigen binding
portions, fragments (including Fab, Fab’, F(ab’)2, Fv, dAb and CDR fragments),
single chain antibodies (scFv), chimeric antibodies, monospecific antibodies,
bispecific antibodies, multi-specific antibodies, diabodies and other
polypeptides, any of which contain at least a portion of an immunoglobulin
variable domain that is sufficient to confer specific

-2-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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antigen binding to the polypeptide; or (c) in each case (a) and (b) above,
humanized or fully human versions thereof.

1.6       “Applicable Laws” means all federal, state, local, national and
supra-national laws, statutes, rules, regulations, ordinances and pronouncements
having the effect of law including any rules, regulations, guidelines, or
requirements of Regulatory Authorities, securities regulatory authorities,
national securities exchanges or securities listing organizations that may be in
effect from time to time during the Term and applicable to a particular activity
hereunder.

1.7       “[***]” means (a) on a Candidate Research Program-by-Candidate
Research Program basis, at least [***] at the [***] as being the [***] to the
[***] for such Candidate Research Program, or (b) with respect to [***] or the
[***], an [***] pursuant to [***] to serve as a [***]. For purposes of clarity,
there is no [***] to [***].

1.8       “BLA” means a Biologics License Application under Title 21 of the
United States Code of Federal Regulations.

1.9       “BPDCN” means Blastic Plasmacytoid Dendritic Cell Neoplasm.

1.10      “Business Day” means any day other than a Saturday, Sunday or other
day on which banking institutions in Boston, Massachusetts or Dublin, Ireland
are required to be closed or are actually closed with legal authorization.

1.11      “Calendar Quarter” means, with respect to the first such Calendar
Quarter during the Term, the period beginning on the Effective Date and ending
on the last day of the calendar quarter within which the Effective Date falls,
and thereafter each successive period of three (3) consecutive months during the
Term ending on March 31, June 30, September 30, or December 31; except that the
last Calendar Quarter during the Term shall end upon the end of the Term in
accordance with Section 9.1.

1.12      “Calendar Year” means, with respect to the first such Calendar Year
during the Term, the period beginning on the Effective Date and ending on
December 31 of the calendar year within which the Effective Date falls, and
thereafter each successive period of twelve (12)

-3-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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consecutive months during the Term commencing on January 1 and ending on
December 31; except that the last Calendar Year during the Term shall end upon
the end of the Term in accordance with Section 9.1.

1.13      “Candidate” means the Lead Candidate [***].

1.14      “Candidate Research Program” means any and all research and
preclinical studies (other than [***]) undertaken by ImmunoGen with respect to a
particular Target after the [***] and prior to [***] in accordance with
Section 3.4, including [***], of any Candidates and the [***] of such Candidates
[***] in such [***] and [***].

1.15      “Change of Control” of a Party means (a) a merger or consolidation of
such Party or a direct or indirect parent of such Party with a Third Party that
results in the voting securities of such Party or its parent outstanding
immediately prior thereto ceasing to represent at least fifty percent (50%) of
the combined voting power of the surviving entity immediately after such merger
or consolidation, or (b) a transaction or series of related transactions in
which a Third Party, together with its Affiliates, becomes the beneficial owner
of fifty percent (50%) or more of the combined voting power of the outstanding
securities of such Party or its direct or indirect parent, or (c) the sale or
other transfer to a Third Party of all or substantially all of such Party’s
business to which the subject matter of this Agreement relates, except, in each
case, in connection with the issuance of equity securities for financing
purposes or to change the domicile of a Party.

1.16      “Co-Development Product” means a Jazz Product for which ImmunoGen has
exercised the ImmunoGen Opt-In Right pursuant to the applicable License
Agreement.

1.17      “Co-Development Territory” means the United States (including its
territories and possessions).

1.18      “Collaboration” means the activities performed by the Parties with
respect to the Candidate Research Programs and the Collaboration Products under
this Agreement.

1.19      “Collaboration Product” means each of (a) [***] IMGN779, [***] with
[***] or [***], in any [***] or [***], (b) [***] IMGN632 (or any [***] Candidate
[***] pursuant to Section

-4-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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3.5), [***] with [***] or [***], in any [***] or [***], or (c) [***] the New
Product (or any [***] Candidate or [***]pursuant to Section 3.5), [***] with
[***] or [***], in any [***] or [***]. For clarity, [***] described in (a) above
shall be considered a [***] Collaboration Product, [***] described in (b) above
shall be considered a [***] Collaboration Product, and [***] described in (c)
above shall be considered a [***] Collaboration Product. For further clarity,
when a Collaboration Product becomes an ImmunoGen Product, it shall cease to be
a Collaboration Product.

1.20      “Commercially Reasonable Efforts” means, with respect to a Party in
carrying out an obligation or activity under this Agreement, the use of efforts
and resources in respect of such activity in accordance with [***] would [***]
or to which [***], and that is of [***] and [***] as [***] and is at [***] as
[***] or [***], taking into account [***], the [***] of the [***] or [***] in
the [***], the [***] and [***] of the [***] or [***] in the [***], the [***]
involved in its [***], the [***], the [***], and other relevant factors
including [***] or [***] factors. Without limiting the foregoing, such efforts
include: (a) [***] for [***] for which such Party is [***] to [***] who are
[***] for the [***] and [***] of [***], (b) [***] and [***] to [***] for [***],
and (c) [***] and [***] and [***] or [***] to [***] with respect to and [***] in
an [***], in each case, [***] with the [***] and [***] in the [***] of [***] for
[***], in each case [***] or to which it has exclusive rights, at a [***] of
[***] or [***] and with [***] and [***] as the [***] or [***] in the [***],
taking into account [***], including [***] and [***] and other [***] and [***]
(including [***] and [***]).

1.21      “Confidential Information” means (a) with respect to ImmunoGen, the
[***] Intellectual Property and (b) with respect to each Party, all information
and Technology that is disclosed hereunder by or on behalf of such Party (in
such capacity, the “Disclosing Party”) to the other Party (in such capacity, the
“Receiving Party”) or to any of the Receiving Party’s or its Affiliates’
employees, consultants or subcontractors (collectively, “Representatives”),
except to the extent that the Receiving Party can demonstrate by written record
or other suitable evidence that such information, (i) as of the date of
disclosure is known to the Receiving Party or its Affiliates other than by
virtue of a prior confidential disclosure by or on behalf of the Disclosing
Party to the Receiving Party or its Affiliates; (ii) as of the date of
disclosure is in, or subsequently

-5-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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enters, the public domain through no fault or omission of the Receiving Party or
its Affiliates or their respective Representatives; (iii) is obtained by the
Receiving Party or its Affiliates from a Third Party without breach of any duty
and without restriction on disclosure or use; or (iv) is independently developed
by or for the Receiving Party or its Affiliates without reference to or reliance
upon any Confidential Information of the Disclosing Party.

1.22      “Confidentiality Agreement” means that certain Confidential Disclosure
Agreement effective October 11, 2016 by and between ImmunoGen and Jazz.

1.23      “Control” or “Controlled” means, with respect to any Patent Rights or
Technology, the possession by a Party of the ability to grant a license or
sublicense of or access to such Patent Rights or Technology and the rights
thereto as contemplated in this Agreement without violating the terms of any
arrangement or agreement between such Party or its Affiliates and any Third
Party in effect at the time of such grant.

1.24      “Cytotoxic Compound” means a MAY Compound, an IGN Compound, or any
other small molecule compound that inhibits the proliferation of cells within
the body or that causes, facilitates, or contributes to cell death.

1.25      “[***]” means the point in time in which the decision is made to [***]
to [***] and [***].

1.26      “[***]” means the point in time in which the decision is made by [***]
into [***] and [***].

1.27      “[***]” means, with respect to particular [***], a written report (or
electronic access to written documentation) containing at least the following
for [***]from such [***]: (a) [***] of all [***] with such [***] in [***],
(b) [***], if available, and if unavailable, [***], of [***] and [***] for such
[***], (c) an [***] of [***] of [***], (d) [***], (e) [***], (f) [***] that
includes at least (i) an [***] with [***] and [***], (ii) [***] and [***], (iii)
[***], (iv) [***], (v) [***], (vi) [***], (vii) [***], (viii) [***] and (ix) a
[***] for [***] and [***], (g) description of [***], including [***], and [***]
and [***], (h) list of [***] and [***] with [***] of [***] of [***], (i) list of
[***] to be used, (j) [***], and (k) a [***] and [***] of such [***] against the
[***].

-6-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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1.28      “[***]” means, with respect to particular [***] in which the [***] has
[***] and is otherwise [***], a written package (or electronic access to written
documentation) that contains at least the following for such [***] and, to the
extent available, for any [***] for such [***]: (a) all [***], including the
[***] and [***], (b) all [***] and the , (c) the [***], (d) all records of
[***], (e) the [***], (f) the [***], (g) a [***] for a [***] such [***], (h) a
[***] of the [***] and [***], (i) all [***], (j) list of [***] and [***] showing
such [***], (k) an [***] of [***]  ([***], and [***]) and [***], (l) [***] on
all [***], (m) [***] on of [***] and [***], (n) the [***] for the [***], (o) all
[***] regarding the [***], (p) the [***] and with [***], (q) [***] of the [***]
and size of all [***] through [***], and (r) a [***] of the [***] and [***] for
each of the [***].

1.29      “Development Plan” means, on a Development Program-by-Development
Program basis, a written plan that [***] an [***] and the [***] to be [***]
during the Term in furtherance of such Development Program pursuant to this
Agreement, as such written plan may be amended, modified or updated in
accordance with Section 5.1.3. Each Development Plan, and any modification,
amendment or update thereto, shall set forth, inter alia, the [***] and [***] of
[***] contained in the [***] as set forth on Section 1.29 of the Disclosure
Letter, including the [***], and a [***] for such [***].

1.30      “Development Program” means, on a Collaboration
Product-by-Collaboration Product basis, any and all [***] and [***] with respect
to such Collaboration Product that are [***] to obtain Regulatory Approval (as
defined in the License Agreement) in the [***] and, if ImmunoGen decides in its
discretion to pursue Regulatory Approval in [***] in the Territory, in such
[***].

1.31      “Disclosure Letter” means the letter delivered by ImmunoGen to Jazz on
the Effective Date in connection with this Agreement.

1.32      “Early Research Programs” means all research programs of ImmunoGen and
its Affiliates that are not Excluded Programs and that have not yet reached
[***].

1.33      “Early Research Program Data Package” means a written report on all
then-existing Early Research Programs containing at least the information set
forth on Section 1.33 of the Disclosure Letter.

-7-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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1.34      “Early Stage Option Data Package” means, on a Collaboration
Product-by-Collaboration Product basis, a written package containing at least
(a) the [***] of the [***] for such Collaboration Product, including the [***],
(b) the [***] of any [***] for the [***] of such Collaboration Product,
(c) [***] of all [***] for such Collaboration Product, (d) [***] of all [***] on
such Collaboration Product and [***] of any [***] for such Collaboration
Product, (e) all [***] from such Collaboration Product [***] including the [***]
and [***], (f) (i) a list of [***] and [***], (ii) (1) to the extent permitted
by the [***] after [***] of [***] to [***] such [***] (which [***]), [***] of
[***] and [***] to [***] used in connection with such Collaboration Product
[***], or (2) to the extent [***] of [***] are [***] by the [***] after such
[***],  [***] of [***] from [***], and (iii) (1) to the extent permitted by the
[***] after [***] of [***] to [***] such [***] (which [***]), [***] of [***] for
the Collaboration Product [***], or (2) to the extent [***] of [***] are [***]
by the [***] after such [***],  [***] from [***], (g) a list of [***] and [***]
in [***] and [***] of such Collaboration Product, (h) [***] that [***] in the
[***] are [***] and [***] as [***], (i) if [***] have been [***], the [***] and
[***] or [***], and if the [***] have [***], any [***] and [***] or [***] (even
if in [***] or [***]), (j) if there are any [***] to [***] or [***] of [***]
since the [***] of [***] or [***], a [***] to the [***] or [***] as appropriate,
(k) all [***], (l) [***] of all [***] and a [***] that [***] an [***] and the
[***] to be [***] under the [***], setting forth, inter alia, the [***] and
[***] of [***] in the [***] as set forth on Section 1.29 of the Disclosure
Letter, including the [***], and a [***] and [***] for such [***], (m) [***] of
the [***] of the [***] and [***] of the [***], (n) the [***] for such
Collaboration Product, (o) all [***] regarding such Collaboration Product, (p) a
list of [***] with such Collaboration Product with a [***] of the [***], (q) a
[***] and [***], (r) a [***] including all [***] pursuant to which ImmunoGen has
[***] a [***] to [***] (which, if the Jazz Option is exercised, shall be set
forth [***] to the License Agreement), (s) a [***] of [***] that are [***] by
ImmunoGen that are [***] to [***] or otherwise [***] the Collaboration Product
(which, if the Jazz Option is exercised, shall be set forth on [***]), (t) [***]
the information [***] to [***] on the [***] delivered on the [***], with respect
to any [***] or [***] the [***] of this Agreement that [***] or [***] set forth
in [***] if such [***] or [***] were [***] as of the [***] and with respect to
any such [***] and [***] that refer specifically to [***] or [***], where such
Collaboration Product is a [***] for [***] or the [***] or the [***] pursuant to
[***], such [***] and [***] shall instead be deemed to [***] to the [***] or the
[***] or the [***], as applicable, to the extent that such [***] and [***] refer

-8-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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specifically to [***] or [***] (which, if the Jazz Option is exercised, shall be
set forth on [***] to the License Agreement), and (u) two (2) original copies of
the License Agreement that have been executed by an authorized representative of
ImmunoGen and that have been modified from the form of License Agreement set
forth in Schedule B solely to (i) accurately identify the applicable Jazz
Product; and (ii) specify the applicable Option Exercise Fee as the upfront
payment in Section 6.1 of the License Agreement (which shall be [***] if such
License Agreement is executed pursuant to [***]) and the applicable royalty
rates in Section 6.4.1 of the License Agreement and any other modifications to
the License Agreement specifically required by the terms of this Agreement.

1.35      “Early Stage Option Period” means, as applicable, the IMGN779 Early
Stage Option Period, IMGN632 Early Stage Option Period or the New Product Early
Stage Option Period.

1.36      “Employment Cost Index” means “[***] published from time to time by
the [***].

1.37      “EU” means the economic, scientific and political organization of
member states of the European Union as it is constituted as of the effective
date of the Collaboration and Option Agreement, whether or not any such member
states may leave the European Union following such date (including the United
Kingdom), and any member states that may be added to the European Union from
time to time following such date.

1.38      “Excluded Program” means any [***] (i) [***], (ii) listed on Section
1.38 of the Disclosure Letter, or (iii) for which (a) ImmunoGen is [***]
(through [***], or [***] for the [***]) or [***] with a [***], and (b) such
[***] has [***] for each such [***] being [***] or [***]. An [***] described in
subsection (iii) above shall be deemed to be an Excluded Program [***] if the
[***] or  or [***], as applicable, in [***] (1) [***] or (2) [***]. If the [***]
or [***] are [***] to [***] or [***], as applicable, in [***] (1) [***] or (2)
[***], then such [***] is [***] and the Parties shall [***] to [***] that would
apply, to the [***] and [***] of [***] from such [***] in [***] or [***] for
which [***] is [***] or [***], if an [***] from such [***] were to [***] and if
[***] to such [***], which [***] should be [***] to the [***] that are set forth
in [***] and the [***] to [***] to the [***] or [***] such [***].

-9-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

1.39      “FDA” means the United States Food and Drug Administration and any
successor agency or authority thereto.

1.40      “FDCA” means the United States Food, Drug and Cosmetic Act, as amended
(21 U.S.C. § 301 et seq.), and the rules and regulations promulgated thereunder.

1.41      “FTE” means a full time equivalent person year (consisting of a total
of [***] hours per year) of scientific or technical work on or directly related
to the provision of the ImmunoGen Activities or any prorated portion of such
equivalent person year. [***] who [***] hours per year [***] shall be [***].

1.42      “FTE Cost” means, for any applicable period during the Funding Term,
the FTE Rate multiplied by the number of FTEs expended over such period.

1.43      “FTE Rate” means, for [***],  [***]; and for each [***], the result
obtained by [***] by the [***] where [***] is [***], the [***] is the [***] for
the [***] of the [***] and the [***] for the [***] the [***], and the [***] is
the [***] for the [***] the [***];  provided,  however, that in no event shall
the FTE Rate for any [***] be less than the [***]. For the avoidance of doubt,
such rate includes all travel expenses. The reported actual time spent shall be
substantiated by a time tracking system consistently applied.

1.44      “Funding Term” means the period beginning on the Effective Date and
ending on the earlier of (a) the seventh (7th) anniversary of the Effective Date
and (b) the last day of the Term.

1.45      “Future Acquirer” means a Third Party acquirer in any Change of
Control transaction involving either Party, and such Third Party acquirer’s
Affiliates other than the applicable acquired Party or any of its Affiliates
prior to such Change of Control.

1.46      “GLP” means all good laboratory practices under Title 21 of the United
States Code of Federal Regulations, as amended from time to time, and comparable
laws and regulations promulgated by the EMA or other Regulatory Authority
applicable to the Territory, as they may be updated from time to time, including
applicable quality guidelines promulgated under the ICH.

-10-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

1.47      “IGN Compound” means any and all [***]benzodiazepine compounds,
whether produced from a botanical source, natural fermentation, chemical
synthesis or otherwise, including all analogs, variants, fragments or
derivatives of any of the foregoing, in each case owned or Controlled by
ImmunoGen.

1.48      “IMGN632” means ImmunoGen’s proprietary ADC that Targets CD123 and is
designated by ImmunoGen as IMGN632 on the Effective Date [***].

1.49      “IMGN779” means ImmunoGen’s proprietary ADC that Targets CD33 and is
designated by ImmunoGen as IMGN779 on the Effective Date [***]r.

1.50      “ImmunoGen Accounting Standards” means US GAAP (United States
Generally Accepted Accounting Principles), as generally and consistently applied
throughout ImmunoGen’s organization.

1.51      “ImmunoGen Activities” means those activities to be undertaken by
ImmunoGen that are associated with (a) the Candidate Research Programs as
described in the Research Plans or (b) the Development Programs as described in
the Development Plans.

1.52      “ImmunoGen Development Costs” means FTE Costs and Out-of-Pocket Costs
reasonably incurred and specifically identifiable by ImmunoGen in connection
with the development of Collaboration Products in accordance with this Agreement
and the applicable Development Plans. ImmunoGen Development Costs exclude
capital expenditures and costs attributable to general corporate activities,
executive management, investor relations, treasury services, business
development, corporate government relations, external financial reporting and
other overhead activities.

1.53      “ImmunoGen Opt-In Right” means ImmunoGen’s right to opt-in to the
co-development and co-commercialization of one (1) Jazz Product in the
Co-Development Territory in accordance with the terms of the applicable License
Agreement.

-11-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

1.54      “ImmunoGen Opt-Out Right” means ImmunoGen’s right to opt-out of the
co-development and co-commercialization of the Jazz Product for which it
previously exercised the ImmunoGen Opt-In Right, pursuant to the applicable
License Agreement.

1.55      “ImmunoGen Product” means (a) any Collaboration Product for which all
Jazz Options have become exercisable, but have expired, in each case without
exercise, (b) any Collaboration Product for which all Jazz Options have
otherwise terminated without exercise, (c) any Collaboration Product that is
deemed to be an ImmunoGen Product pursuant to Section 3.5.1 or 3.5.2, or (d) any
Collaboration Product for which Jazz has exercised the Jazz Opt-Out pursuant to
Section 6.2.4, in each case, whether alone or in combination with one or more
other active ingredients, in any dosage form, formulation or strength.

1.56      “IND” means (a) an Investigational New Drug Application (as defined in
the FDCA and regulations promulgated thereunder) or any successor application or
procedure required to initiate clinical testing of an ADC in humans in the
United States; (b) a counterpart to an Investigational New Drug Application that
is required in any other country or region in the Territory before beginning
clinical testing of an ADC in humans in such country or region; and (c) all
supplements and amendments to any of the foregoing.

1.57      “Interim Data Package” means, on a Collaboration
Product-by-Collaboration Product basis, a written package containing:

(a)        if Jazz requests the Interim Data Package during the [***] of a
Collaboration Product (i) a list of all [***] and [***] and [***] with such
Collaboration Product, (ii) a [***] of the [***] of all [***] and [***] with
such Collaboration Product, (iii) [***] and [***] for such Collaboration
Product, (iv) the [***] for the [***] for such Collaboration Product and [***],
(v) [***] and [***] of the [***] for such Collaboration Product, if available,
or [***], if available, (vi) [***] for such Collaboration Product, (vii) the
[***] of any [***] of the [***] for such Collaboration Product, (viii) [***] of
all [***] for such Collaboration Product, (ix) [***] of all [***] on such
Collaboration Product, (x) [***] from the [***] for such Collaboration Product,
(xi) (1) a list of [***] and [***], (2) (A) to the extent permitted by the [***]
after [***] of [***] to  (which [***]), [***] of [***] and [***] to [***] used
in connection with such Collaboration

-12-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

Product [***], or (B) to the extent [***] of [***] are [***] by the [***] after
such [***],  [***] of [***] from [***], and (3) (A) to the extent permitted by
the [***] after [***] of [***] to [***] such [***] (which efforts ImmunoGen
shall make), audit reports of [***] for the Collaboration Product [***], or (B)
to the extent [***] of [***] are [***] by the [***] after such [***],  [***]
from [***] (xii) a list of all [***] and [***] in [***] and [***] of such
Collaboration Product, (xiii) list of [***] in the [***] that have been [***]
and [***] as [***], (xiv) if there are any [***] made to [***] or [***] of [***]
since the [***] of [***] or [***], a [***] to the [***] or [***] as appropriate,
(xv) all available [***] and a list of all [***], (xvi) [***] of the [***] of
the [***] and [***] of the [***], (xvii) the [***] for such Collaboration
Product, (xviii) all [***] regarding such Collaboration Product, (xix) a [***]
and [***], (xx) a [***] including all [***] pursuant to which ImmunoGen has
[***] a [***] to [***] (which, if the Jazz Option is exercised, shall be set
forth on [***] to the License Agreement), (xxi) a [***] of [***] that are [***]
by ImmunoGen that are [***] to [***] or otherwise [***] the Collaboration
Product (which, if the Jazz Option is exercised, shall be set forth on [***]),
(xxii) a [***] with respect to any [***] or [***] occurring [***] of this
Agreement that [***] or [***] set forth in [***] if such [***] or [***] were
[***] as of the [***] and with respect to any such [***] and [***] that refer
specifically to [***] or [***],  where such Collaboration Product is a [***] for
[***] or the [***] or the [***] pursuant to [***], such [***] and [***] shall
instead be deemed to refer to the [***] or the [***] or the [***], as
applicable, to the extent that such [***] and [***] refer specifically to [***]
or [***], and (xxiii) two (2) original copies of the License Agreement that have
been executed by an authorized representative of ImmunoGen and that have been
modified from the form of License Agreement set forth in Schedule B solely to
(1) accurately identify the applicable Jazz Product; and (2) specify the
applicable Option Exercise Fee as the upfront payment in Section 6.1 of the
License Agreement and the applicable royalty rates in Section 6.4.1 of the
License Agreement and any other modifications to the License Agreement
specifically required by the terms of this Agreement, or

(b)        if Jazz requests the Interim Data Package during the [***], (i) all
available [***] of all [***] with such Collaboration Product, (ii) a list of all
[***] and [***] and [***] with such Collaboration Product, (iii) a [***] of the
[***] of all [***] and [***] with such Collaboration Product, (iv) all [***] and
[***] for such Collaboration Product, (v) the [***] for all [***] of such
Collaboration Product and [***], (vi) if [***] for the [***] for such
Collaboration Product, all

-13-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

[***] and [***] of the [***] or if such [***] and [***] are [***], a [***],
(vii) [***] for such Collaboration Product, (viii) [***] of all [***] of all
such Collaboration Product [***], (ix) [***] of all [***] for such Collaboration
Product, (x) [***] of all [***] on such Collaboration Product, (xi) [***] from
all [***] with such Collaboration Product, (xii) (1) a list of [***] and [***],
(2) (A) to the extent permitted by the  of [***] to [***] such [***] (which
[***]), [***] of [***] and [***] to [***] of [***] in connection with such
Collaboration Product [***], or (B) to the extent [***] of [***] are [***] by
the [***] after such [***],  [***] of [***] from [***], and (3) (A) to the
extent permitted by the [***] after [***] of [***] to [***] such [***] (which
[***]), [***] of [***] for the Collaboration Product [***], or (B) to the extent
[***] of [***] are [***] by the [***] after such [***],  [***] from [***],
(xiii) a list of all [***] and [***] in [***] and [***] of such Collaboration
Product; (xiv) copies of the [***] in connection with all [***], (xv) a list of
[***] that are [***] (if [***] listed in the [***]) or [***] (if [***]), (xvi) a
report [***] that the [***] is [***] and [***], (xvii) all [***] and a list of
all [***], (xviii) a [***] of [***] (such as [***] and [***]) and [***], (xix)
if [***] have been [***], the [***] and [***] or [***], and if the [***] have
[***] any [***] and [***] or [***] (even if in [***] or [***]), (xx) if there
are any [***] made to [***] or [***] since [***] or [***], a [***] to the [***]
or [***] as appropriate, (xxi) the [***] for such Collaboration Product,
(xxii) all [***] regarding such Collaboration Product, (xxiii) a [***] and
[***], (xxiv) a [***] including all [***] pursuant to which ImmunoGen has [***]
a [***] to [***] (which, if the Jazz Option is exercised, shall be set forth on
[***]), (xxv) a [***] of [***] that are [***] by ImmunoGen that are [***] to
[***] or otherwise [***] the Collaboration Product (which, if the Jazz Option is
exercised, shall be set forth [***] to the License Agreement), (xxvi) a [***]
with respect to any [***] or [***] the [***] of this Agreement that [***] or
[***] set forth in [***] if such [***] or [***] were [***] as of the [***] and
with respect to any such [***] and [***] that refer specifically to [***] or
[***],  where such Collaboration Product is a [***] for [***] or the [***] or
the [***] pursuant to [***], such [***] and [***]s shall instead be deemed to
[***] to the [***] for [***] or the [***] or the [***], as applicable, to the
extent that such [***] and [***] refer specifically to [***] or [***], and
(xxvii) two (2) original copies of the License Agreement that have been executed
by an authorized representative of ImmunoGen and that have been modified from
the form of License Agreement set forth in Schedule B solely to (1) accurately
identify the applicable Jazz Product; and (2) specify the applicable Option
Exercise Fee as the upfront payment in Section 6.1 of the License Agreement and
the applicable royalty rates in

-14-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

Section 6.4.1 of the License Agreement and any other modifications to the
License Agreement specifically required by the terms of this Agreement.

1.59      “Jazz Development Costs” means FTE Costs and Out-of-Pocket Costs
(applied mutatis mutandis to Jazz) reasonably incurred and specifically
identifiable by Jazz to develop a Collaboration Product for which Jazz is deemed
to have exercised the Jazz Option pursuant to [***], commencing upon such
exercise and continuing until (a) in the case of [***] or [***], Jazz has [***]
that [***] to [***] for the applicable Jazz Product (or, if earlier, Jazz [***]
to [***]) as well as [***] required to be [***] in the [***] for such Jazz
Product (had it remained a Collaboration Product) or (b) in the case of a [***]
or [***], Jazz has [***] that [***] to [***] for the applicable Jazz Product
(or, if earlier, Jazz [***]) as well as [***] required to be [***] in the Late
Stage Option Data Package for such Jazz Product (had it remained a Collaboration
Product). Jazz Development Costs exclude capital expenditures and costs
attributable to general corporate activities, executive management, investor
relations, treasury services, business development, corporate government
relations, external financial reporting and other overhead activities.

1.60      “Jazz Option” means a Jazz Early Stage Option or Jazz Late Stage
Option.

1.61      “Jazz Option Period” means any one of the IMGN779 Option Period, the
IMGN632 Option Period, and the New Product Option Period.

1.62      “Jazz Product” means a Collaboration Product for which (a) Jazz has
exercised a Jazz Option in accordance with Section 4.4, and (b) ImmunoGen has
either (i) not exercised the ImmunoGen Opt-In Right or (ii) exercised the
ImmunoGen Opt-In Right and subsequently exercised the ImmunoGen Opt-Out Right.

1.63      “Knowledge” means the actual knowledge [***] of all ImmunoGen
“executive officers” (as defined in Rule 3b-7 promulgated under the Securities
Exchange Act of 1934, as amended) and [***].

1.64      “Late Stage Option Data Package” means, on a Collaboration
Product-by-Collaboration Product basis, a written package containing at least,
(a) the [***] of all [***] with such Collaboration Product, (b) the [***] of all
such Collaboration Product [***]s, (c) [***] of all

-15-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

[***] for such Collaboration Product, (d) [***] of all [***] on such
Collaboration Product and [***] of [***] of any [***] for such Collaboration
Product, (e) all [***] from all [***] with such Collaboration Product, including
the [***] and [***] for the [***] or [***] in [***] and [***] with [***] in
[***] and [***], (f) (i) a list of [***] and [***], (ii) (1) to the extent
permitted by the [***] after [***] of [***] to [***] such [***] (which [***]),
[***] of [***] and [***] to [***] of [***] in connection with such Collaboration
Product [***], or (2) to the extent [***] of [***] are  by the [***] after such
[***],  [***] of [***] from [***], and (iii) (1) to the extent permitted by the
[***] after [***] of [***] to [***] such [***] (which [***]), [***] of [***] for
the Collaboration Product [***], or (2) to the extent [***] of [***] are [***]
by the [***] after such [***],  [***] from [***], (g) copies of the [***] in
connection with all [***], (i) [***] that all [***] are [***] (if [***] listed
in the [***]) or [***] (if [***] as [***]), (j) a [***] that the [***] is [***]
and [***], (k) all [***], (l) a [***] of [***], (m) for [***], (n) if there are
any  since [***] or [***], a [***] showing [***] to the [***] or [***] as
appropriate, (o) the [***] for such Collaboration Product, (p) all [***]
regarding such Collaboration Product, (q) a list of any [***] with such
Collaboration Product with a [***], (r) a [***] that [***] an [***] and the
[***] to be [***] under the [***], setting forth, inter alia, the [***]
contained in the [***] as set forth on [***], including the [***], and a [***]
and [***] for such [***], (s) a [***] and [***], (t) a [***] including all [***]
pursuant to which ImmunoGen has [***] a [***] to [***] (which, if the Jazz
Option is exercised, shall be set forth on [***]), (u) a [***] of [***] that are
[***] by ImmunoGen that are [***] to [***] or otherwise [***] the Collaboration
Product (which, if the Jazz Option is exercised, shall be set forth on [***] to
the License Agreement), (v) a [***] the [***] on [***] on the [***] of this
Agreement, with respect to any [***] or [***] the [***] of this Agreement that
[***] any [***] or [***] set forth in [***] if such [***] or [***] were [***] as
of the [***] and with respect to any such [***] and [***] that refer
specifically to [***] or [***], where such Collaboration Product is a [***] for
[***] or the [***] or the [***] pursuant to [***], such [***] and [***] shall
instead be deemed to [***] to the [***] for [***] or the [***] or the [***], as
applicable, to the extent that such [***] and [***] refer specifically to [***]
or [***] (which, if the Jazz Option is exercised, shall be set forth on [***] to
the License Agreement), and (w) two (2) original copies of the License Agreement
that have been executed by an authorized representative of ImmunoGen and that
have been modified from the form of License Agreement set forth in Schedule B
solely to (i) accurately identify the applicable Jazz Product; and (ii) specify
the applicable Option Exercise Fee as the upfront payment

-16-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

in Section 6.1 of the License Agreement (which shall [***] if such License
Agreement is executed pursuant to [***]) and the applicable royalty rates in
Section 6.4.1 of the License Agreement and any other modifications to the
License Agreement specifically required by the terms of this Agreement.

1.65      “Late Stage Option Period” means, as applicable, the IMGN779 Late
Stage Option Period, IMGN632 Late Stage Option Period or the New Product Late
Stage Option Period.

1.66      “Lead Candidate” means, on Candidate Research Program-by-Candidate
Research Program basis, the ADC candidate selected by the JRDC at the [***] to
[***].

1.67      “License Agreement” means a written license agreement executed by the
Parties pursuant to Section 4.3 in the form set forth on Schedule B attached
hereto.

1.68      “Licensed Intellectual Property” has the meaning ascribed to such term
in the License Agreement.

1.69      “Linker” means any compound or composition [***] under this Agreement
to, or [***] under this Agreement as useful to, link a Cytotoxic Compound and an
Antibody together to form a conjugate of such Cytotoxic Compound with the
Antibody.

1.70      “MAA” means an application filed with the relevant Regulatory
Authorities in the EU seeking regulatory approval to market and sell a
Collaboration Product in the EU or any country or territory therein.

1.71      “MAY Compound” means any and all maytansinoid compounds (including
maytansinol, ansamitocins, DM1 and DM4), whether produced by a botanical source,
natural fermentation, chemical synthesis or otherwise, including all variants,
fragments, or derivatives of any of the foregoing, in each case owned or
Controlled by ImmunoGen.

1.72      “MDS” means Myelodysplastic Syndromes.

1.73      “NDA” means a New Drug Application (as more fully described in 21
C.F.R. Parts 314 et seq. or its successor regulation).

-17-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

1.74      “New Product” means (a) the Lead Candidate from a Candidate Research
Program, such Candidate Research Program selected by Jazz during the Funding
Term in accordance with the terms of this Agreement, and (b) any applicable
[***] of the foregoing. Subject to Section 3.5, in no event shall there be more
than one (1) New Product at any particular time. The term “New Product” shall
also refer to [***], as applicable.

1.75      “New Product Target” mean the Target Targeted by the New Product.

1.76      “Option Exercise Fee” means the payment made by Jazz following
execution of a License Agreement, the amount of which shall be as set forth on
Schedule A attached hereto.

1.77      “Out-of-Pocket Costs” means expenses paid by ImmunoGen to Third
Parties that are specifically identifiable through contract, purchase order, or
invoice and incurred for services or materials provided by such Third Parties
directly in their performance of the Development Programs, and for the avoidance
of doubt, not including pre-paid amounts (until expensed in accordance with
applicable ImmunoGen Accounting Standards). For clarity, Out-of-Pocket Costs
exclude any costs paid to Affiliates or included in capital expenditures,
payments for personnel (such as internal salaries or benefits), travel,
facilities, utilities, general office or laboratory supplies, information
technology, and the like.

1.78      “Patent Rights” means the rights and interests in and to any and all
issued patents and pending patent applications (including inventor’s
certificates, applications for inventor’s certificates, statutory invention
registrations, applications for statutory invention registrations, utility
models and any foreign counterparts thereof) in any country or jurisdiction in
the Territory, including any and all reissues, confirmations, registrations,
validations, provisionals, non-provisionals, substitutions, continuations,
continuations-in-part, divisionals and other continuing applications, extensions
or restorations by existing or future extension or restoration mechanisms,
including patent term extension, supplementary protection certificates or the
equivalent, renewals, and all letters patent on any of the foregoing, and any
and all reissues, reexaminations, additions, extensions, confirmations,
registrations and patents of addition on any of the foregoing.

1.79      “Person” means an individual, sole proprietorship, partnership,
limited partnership, limited liability partnership, corporation, limited
liability company, business trust, joint stock

-18-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

company, trust, incorporated association, joint venture or similar entity or
organization, including a government or political subdivision, department or
agency of a government.

1.80      “Prioritize” means, with respect to the [***] or [***], the use of
[***], including [***] the [***] and [***] consistent with the [***], (a) if
such research program is an [***], to [***] to a [***] and [***] to [***] with
the [***], and [***] in the [***] with the [***] of [***] a  to Jazz for such
[***] as [***] provided by ImmunoGen pursuant to Section 3.4 and with [***] and
[***] to the [***] that ImmunoGen has [***] to be in the [***] of the [***]
(with such [***] being [***] by ImmunoGen [***] in the [***] of its [***] of
[***]), or (b) if such [***] is a [***], to [***] such Candidate Research
Program [***] with the [***], and [***] in the [***] with the [***] a [***] to
Jazz for such [***] as  provided by ImmunoGen pursuant to Section 3.4 and with
[***] and resources devoted by ImmunoGen to the ImmunoGen research programs that
ImmunoGen has [***] to be in the [***] of the [***] (with such [***] being [***]
by ImmunoGen [***] in the [***] of its [***] of [***]).

1.81      “Product Patent Rights” means Patent Rights Controlled by ImmunoGen or
its Affiliates as of the Effective Date or during the Term [***] (all of the
foregoing being hereinafter referred to as “Product Patent Claims”). [***]

1.82      “Regulatory Authority” means the FDA or any counterpart to the FDA
outside the United States, or any other national, supra-national, federal,
regional, state, local, municipal or provincial regulatory agency, department,
bureau, commission, council or other governmental entity with authority over the
distribution, importation, exportation, manufacture, production, use, storage,
transport, clinical testing or sale of an ADC.

1.83      “Regulatory Filings” means, collectively: (a) all INDs, NDAs, BLAs,
CTAs, establishment license applications, drug master files, applications for
designation as an “Orphan Product” under the Orphan Drug Act, and all other
similar submissions (including MAAs and counterparts to any of the foregoing in
any country or region in the Territory) as may be required by any Regulatory
Authority for the development, manufacture, use or commercialization of a
Collaboration Product in the Territory; (b) all supplements and amendments to
any of the

-19-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

foregoing; and (c) all data and other information contained in, and
correspondence relating to, any of the foregoing.

1.84      “Research Plan” means the separate written plans describing the
research activities to be carried out by ImmunoGen during the Term (in
reasonable detail for the [***]) until Jazz has selected a New Product pursuant
to Section 3.4, in furtherance of each Candidate Research Program pursuant to
this Agreement, as such written plans may be amended, modified or updated. The
Research Plans, and any modification, amendment or update thereto, shall set
forth, inter alia, the scope and detail of information set forth on Section 1.84
of the Disclosure Letter, including the [***], and a [***] for such [***].

1.85      “Similar Market Opportunity” means an oncology indication for which
the then most current estimates in the Decision Resources Epidemiology patient
database (or a successor thereto) indicate a [***] incident population of at
least [***].

1.86      “[***] New Product Target” means the Target Targeted by the [***], if
one is selected by Jazz pursuant [***].

1.87      “Target” means, when used as a noun, a protein described by a unique
UniProtKB/Swiss Prot accession number (and all fragments, mutations and splice
variants thereof).

1.88      “Target,” “Targeting” or “Targeted” means, when used as a verb to
describe the relationship between a molecule and a Target, that the molecule’s
primary intended mechanism of action is to specifically bind to the Target (or a
portion thereof).

1.89      “Technology” means, collectively, all inventions, discoveries,
improvements, trade secrets and proprietary methods or materials, whether or not
patentable, including macromolecular sequences, data, formulations, processes,
techniques, know-how and results (including negative results).

1.90      “Territory” means all countries and jurisdictions of the world.

-20-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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1.91      “Third Party” means any Person other than ImmunoGen, Jazz and their
respective Affiliates.

1.92      “Vyxeos Third Party Combination Trials” means any clinical trial for
which Jazz or its Affiliates provides to a Third Party Jazz’s proprietary
product, Vyxeos, or any other product or product candidate that is proprietary
to Jazz or its Affiliates but for which Jazz and its Affiliates are not the
sponsor and do not provide any additional support or funding.

Additional Definitions. In addition, each of the following definitions shall
have the respective meanings set forth in the section of the Agreement indicated
below:

 

 

Definition

Section

Accelerated Rules

13.13.2(b)

Accelerated Rules Tribunal

13.13.2(b)

[***]

[***]

Agreement

Recitals

Alliance Managers

2.1.1

Anti-Corruption Laws

11.6

Arbitration

13.13.2(a)

Assigned Intellectual Property

8.1.1

[***]

[***]

[***]

[***]

Burdened Technology

5.7.1

Burdened Technology Obligations

5.7.1

CMO Agreement

5.4.2

Combination

10.1.9

Combination Trial

5.1.7

Combination Trial Agreement

5.1.7

Commercialization

10.1.1

Competing Product

5.5.2

Competing Program

5.5.3

Cost Summary

6.2.2

 

-21-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

 

 

Definition

Section

CPR Rules Tribunal

13.13.2(a)

[***]

[***]

Development

10.1.2

Disclosing Party

1.21

Dispute

13.13.1

Divestiture

5.5.3

Drug Approval Application

10.1.3

[***]

[***]

[***]

[***]

Effective Date

Recitals

[***]

[***]

Expired Jazz Option

4.5

[***]

[***]

[***]

[***]

First Commercial Sale

10.1.4

First [***] Late Stage Option Period

[***]

Generic Competition

10.1.5

Generic Product

10.1.6

[***] Early Stage Option Period

[***]

[***] Late Stage Option Period

[***]

[***] Option Period

[***]

[***] Early Stage Option Period

[***]

[***] Late Stage Option Period

[***]

[***] Option Period

[***]

ImmunoGen

Recitals

ImmunoGen Indemnitees

12.1.1

ImmunoGen Licensee

10.1.7

ImmunoGen Royalty Term

10.3

ImmunoGen Standard Exchange Rate Methodology

10.1.8

Improvement

1.2

-22-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

 

 

Definition

Section

Indemnified Party

12.2

Indemnifying Party

12.2

Jazz

Recitals

Jazz Development Funding

6.2.1(a)

Jazz Development Funding Cap

6.2.1(a)

Jazz Early Stage Option

4.1

Jazz Indemnitees

12.1.2

Jazz Late Stage Option

4.1

Jazz Opt-Out

6.2.4(a)

JRDC

2.3.1

JSC

2.2.1

Knowledge

11.5.1

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

Losses

12.1.1

[***]

[***]

Net Sales

10.1.9

[***] Early Stage Option Period

[***]

[***] Late Stage Option Period

[***]

[***] Option Period

[***]

Opt-Out Collaboration Product

6.2.4(b)

Party/Parties

Recitals

Product Patent Claims

1.81

Receiving Party

1.21

Representatives

1.21

Revised Jazz Development Funding Cap

6.2.4(a)

[***]

[***]

[***]

[***]

SEC

7.2.3

 

-23-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

 

 

Definition

Section

Second [***] Late Stage Option Period

[***]

Senior Officers

13.13.1

[***]

[***]

Term

9.1

Third Party Claims

12.1.1

Tribunal

13.13.2(b)

Upfront Fee

6.1

 

ARTICLE II
COLLABORATION MANAGEMENT

2.1       Alliance Management.

2.1.1      Appointment of Alliance Managers. Promptly after the Effective Date,
the Parties shall each appoint an individual who shall oversee contact between
the Parties for all matters related to this Agreement and the Parties’
respective activities hereunder (the “Alliance Managers”). The Alliance Managers
may not be members of the JSC or the JRDC and will not have any voting rights
thereon, but the Alliance Managers may attend all meetings of the JSC and the
JRDC and may bring to the attention of the JSC and the JRDC any matters or
issues either of them reasonably believes should be discussed by the JSC or the
JRDC. Each Party may replace its Alliance Manager at any time by notice to the
other Party.

2.1.2      Responsibilities. The Alliance Managers shall have the responsibility
of creating and maintaining a constructive work environment between the Parties
for all matters related to this Agreement and the Parties’ respective activities
hereunder. Without limiting the generality of the foregoing, the Alliance
Managers shall:

(a)        identify and bring to the attention of their respective managements
any disputes arising between the Parties related to this Agreement or the
Parties’ respective activities hereunder in a timely manner, including any
asserted occurrence of a material breach by a Party, and function as the point
of first referral in the resolution of each dispute;

-24-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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(b)       provide a single, continuous point of communication between the
Parties with respect to this Agreement and the Parties’ respective activities
hereunder;

(c)        plan and coordinate efforts and external communications by or between
the Parties with respect to this Agreement and the Parties’ respective
activities hereunder;

(d)       take such steps as may be required to ensure that meetings of the JSC
and JRDC occur as set forth in this Agreement, that procedures are followed with
respect to such meetings (including the giving of proper notice and the
preparation and approval of minutes) and that relevant action items resulting
from such meetings are appropriately carried out or otherwise addressed; and

(e)        undertake such other responsibilities as set forth in this Agreement
or as the Parties may mutually agree in writing.

2.2       Joint Steering Committee.

2.2.1      Mandate and Establishment of Committee. Promptly after the Effective
Date, the Parties shall establish a joint steering committee (the “JSC”) to
serve as a forum for the general oversight and coordination of the
Collaboration. Within [***] days after the Effective Date, the Parties shall
each nominate up to three (3) representatives for membership on the JSC. Each
Party may change its representatives as it deems appropriate by written notice
to the other Party; provided that neither Party may have more than three (3)
representatives and that each representative is an officer or employee of the
applicable Party or its Affiliate who has sufficient experience and
responsibility within such Party to make decisions arising within the scope of
the JSC’s responsibilities. From time to time, the JSC may establish one or more
sub-teams comprised of qualified representatives of both Parties to undertake
specific responsibilities of the JSC, which sub-teams shall be governed in the
same manner and subject to the relevant requirements set forth herein for the
JSC. If any sub-team fails to reach unanimous agreement on a matter before it
within [***] days, the sub-team will refer the matter to the JSC.

2.2.2      Co-Chairs of JSC. Each Party shall nominate a co-chair of the JSC.
The co-chairpersons are responsible on an alternating basis for preparing
reasonably detailed written

-25-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

minutes of JSC meetings that reflect all material decisions made at such
meetings. The applicable co-chairperson will prepare minutes of each JSC meeting
and will send draft minutes to each representative of the JSC for review and
approval within [***] Business Days after the JSC meeting. Such minutes shall be
deemed approved unless one or more JSC representatives object to the accuracy of
such minutes within [***] Business Days after receipt. The co-chairpersons shall
have no additional powers or rights beyond those held by other JSC
representatives.

2.2.3      Meetings. The JSC shall meet on [***] basis or other schedule agreed
upon by the Parties, unless the Parties mutually agree in advance of any
scheduled meeting that there is no need for such meeting. In such instance, the
next JSC meeting shall also be scheduled as agreed upon by the Parties. In
addition, either Party may call for a JSC meeting at any time by providing at
least [***] days’ notice to the other Party. The location of meetings of the JSC
shall alternate between ImmunoGen’s offices and Jazz’s offices, unless otherwise
agreed by the Parties. As agreed upon by the Parties, JSC meetings may be
face-to-face or may be conducted through teleconferences or videoconferences. In
addition to its JSC representatives, each Party may have other employees,
agents, or consultants attend such meetings to observe, present, and participate
in discussion, but such attendees will not have any decision-making capacity.
Each Party shall bear its own costs and expenses, including travel and lodging
expense, that may be incurred by JSC representatives or other attendees at JSC
meetings, as a result of such meetings hereunder.

2.2.4      Decision Making. All decisions of the JSC will be made by consensus,
with each Party having collectively one (1) vote. If the JSC is unable to reach
unanimous agreement on any matter within [***] days following the date such
matter was first put to a vote, then the JSC will refer such matter to the
Senior Officers for resolution by good faith negotiations commencing promptly
after such notice is received. If the Senior Officers are not able to resolve
such matter within [***] days following delivery of the notice referring the
matter to the Parties’ respective Senior Officers, then [***], but shall [***]
in good faith after [***];  provided, that [***] may [***] pursuant to this
Section 2.2.4 (i) in a manner that [***] any of its [***], or (ii) in a manner
that [***] or other [***] under this Agreement.

2.2.5      Responsibilities. The JSC shall be responsible for the following:

-26-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

(a)        periodically reviewing, discussing, coordinating and approving the
overall strategy and goals for the Collaboration;

(b)       establishing and overseeing joint sub-teams to oversee particular
projects or activities within the purview of the JSC;

(c)        serving, in accordance with [***], as a forum [***] under this
Agreement [***] regarding the conduct of the Candidate Research Programs and the
Development Programs; and

(d)       undertaking such other responsibilities as set forth in this Agreement
or as the Parties may mutually agree in writing.

2.3       Joint Research and Development Committee.

2.3.1      Mandate and Establishment of Committee. Promptly after the Effective
Date, the Parties shall establish a joint research and development committee
(the “JRDC”) to serve as a forum for coordination and communication between the
Parties with respect to (a) ImmunoGen’s conduct of the Early Research Programs,
(b) ImmunoGen’s conduct of the Candidate Research Programs pursuant to the
Research Plans, and (c) ImmunoGen’s development of the Collaboration Products
pursuant to the Development Plans. Within [***] days after the Effective Date,
the Parties shall each nominate between two (2) and five (5) (inclusive)
representatives for membership on the JRDC. Each Party may change its
representatives as it deems appropriate by written notice to the other Party;
provided that neither Party may have fewer than two (2) or more than five (5)
representatives and that each representative is an officer or employee of the
applicable Party or its Affiliate who has sufficient experience and
responsibility within such Party to make decisions arising within the scope of
the JRDC’s responsibilities. From time to time, the JRDC may establish one or
more sub-teams comprised of qualified representatives of both Parties to
undertake specific responsibilities of the JRDC, which sub-teams shall be
governed in the same manner and subject to the relevant requirements set forth
herein for the JRDC. If any sub-team fails to reach unanimous agreement on a
matter before it within [***] days, the sub-team will refer the matter shall to
the JRDC.

-27-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

2.3.2      Co-Chairs of JRDC. Each Party shall nominate a co-chair of the JRDC.
The co-chairpersons are responsible on an alternating basis for preparing
reasonably detailed written minutes of JRDC meetings that reflect all material
decisions made at such meetings. The applicable co-chairperson will prepare
minutes of each JRDC meeting and will send draft minutes to each representative
of the JRDC for review and approval within [***] Business Days after the JRDC
meeting. Such minutes shall be deemed approved unless one or more JRDC
representatives object to the accuracy of such minutes within [***] Business
Days after receipt. The co-chairpersons shall have no additional powers or
rights beyond those held by other JRDC representatives.

2.3.3      Meetings. The JRDC shall meet on a Calendar Quarterly basis or other
schedule agreed upon by the Parties, unless the Parties mutually agree in
advance of any scheduled meeting that there is no need for such meeting. In such
instance, the next JRDC meeting shall also be scheduled as agreed upon by the
Parties. In addition, either Party may call for a JRDC meeting at any time by
providing at least [***] days’ notice to the other Party. The location of
meetings of the JRDC shall alternate between ImmunoGen’s offices and Jazz’s
offices, unless otherwise agreed by the Parties. As agreed upon by the Parties,
JRDC meetings may be face-to-face or may be conducted through teleconferences or
videoconferences, provided that at least one (1) JRDC meeting during any
Calendar Year shall be conducted face-to-face, unless otherwise agreed to by the
Parties. In addition to its JRDC representatives, each Party may have other
employees, agents, or consultants attend such meetings to observe, present and
participate in discussion, but such attendees will not have any decision-making
capacity. Each Party shall bear its own costs and expenses, including travel and
lodging expense, that may be incurred by JRDC representatives or other attendees
at JRDC meetings, as a result of such meetings hereunder.

2.3.4      Decision Making. All decisions of the JRDC will be made by consensus,
with each Party having collectively one (1) vote. If the JRDC is unable to reach
unanimous agreement on any matter within its authority within [***] days
following the date such matter was first put to a vote, then the JRDC shall
refer the matter to [***] for resolution in accordance with [***].

2.3.5      Responsibilities. The JRDC shall be responsible for the following:

-28-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

(a)        reviewing and discussing the relative priority of the Targets to be
pursued in new Early Research Programs;

(b)       discussing the results, plans and timelines for the Early Research
Programs following an update with respect thereto by ImmunoGen;

(c)        reviewing, approving, and discussing the results from, the Research
Plans for Candidate Research Programs, and any material amendment, modification
and update thereto;

(d)       selecting the Lead Candidate [***] for each Candidate Research
Program;

(e)        overseeing the Development Programs and reviewing and discussing the
results therefrom;

(f)        reviewing and approving the initial Development Plan for each
Candidate for which ImmunoGen provides Jazz [***];

(g)        reviewing and approving the Development Plan for each Collaboration
Product and any material amendment, modification and update thereto, each such
Development Plan to be updated at least annually;

(h)       determining the likelihood of [***];

(i)        establishing and overseeing joint sub-teams to oversee particular
projects or activities within the purview of the JRDC; and

(j)        undertaking such other responsibilities as the Parties may mutually
agree in writing.

2.3.6      Discontinuation of the JRDC. The JRDC shall continue to exist until
the first to occur of (a) the expiration or termination of the Term of this
Agreement and (b) the Parties mutually agreeing to disband the JRDC.

-29-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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2.4       Committee Consolidation with License Agreement(s). Notwithstanding the
provisions of this Article II, the JSC and the JRDC shall each consist of the
same representatives, respectively, as the JSC and JDC established under the
License Agreement(s) for so long as both this Agreement and one or more License
Agreements are in full force and effect at the same time, all meetings of the
JSC under this Agreement and the JSC under all License Agreements shall be
scheduled at the same time and locations, and all meetings of the JRDC under
this Agreement and the JRDC under all License Agreements shall be scheduled at
the same time and locations.

ARTICLE III
OVERVIEW; RESEARCH PROGRAMS

3.1       Overview. Commencing on the Effective Date, ImmunoGen shall continue
the development of IMGN779 and IMGN632 in collaboration with Jazz in accordance
with their respective Development Plans, and as set forth in this Agreement.
After the Effective Date, Jazz shall have the option to select a New Product in
accordance with Section 3.4, which shall then be developed by ImmunoGen in
collaboration with Jazz in accordance with its Development Plan and as set forth
in this Agreement.

3.2       Early Research Programs. ImmunoGen shall conduct the Early Research
Programs with the goal of advancing the most promising Early Research Programs
to Candidate Research Programs. ImmunoGen shall update the JRDC at each meeting
with respect to, and the Parties shall discuss at such meeting, the Early
Research Programs, including the results arising from and progress made in each
Early Research Program since the previous JRDC meeting, the plans for advancing
each Early Research Program to [***], and the activities included in such plans
and the timelines for conducting such activities. [***] may [***] for [***] at
the JRDC. [***] shall [***] with regard to the Early Research Programs [***].
Notwithstanding the foregoing or anything to the contrary in this Agreement, and
provided that [***] has [***] pursuant to [***],  [***] shall have the [***],
for [***], to [***] for [***]. After such [***],  [***] shall [***] such [***].
For clarity, if [***],  [***] shall [***] in accordance with this Section 3.2.
In addition to the updates at JRDC meetings, each time that ImmunoGen delivers
[***] to Jazz pursuant to Section 3.4, ImmunoGen shall also provide Jazz with an
[***] that describes the [***] at such time and includes .

-30-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

3.3       Candidate Research Programs.

3.3.1      Objectives of the Candidate Research Programs. The objectives of each
Candidate Research Program are the identification and testing of an ADC that is
ready for IND filing and suitable for selection by Jazz as the New Product that
ImmunoGen will clinically develop under this Agreement and for which Jazz has an
option to obtain an exclusive license to further develop and commercialize as a
Jazz Product under a License Agreement.

3.3.2      Research Under the Research Plans. During the Term and until such
time as Jazz has selected a New Product in accordance with Section 3.4,
ImmunoGen shall prepare a Research Plan regarding each Candidate Research
Program for the JRDC’s review and approval and shall perform research according
to such Research Plans as approved by the JRDC. Each Research Plan shall
describe activities that are reasonably designed to achieve the objective of the
applicable Candidate Research Program. Each Research Plan shall be [***] and
shall describe the research activities to be carried out by ImmunoGen (a) in
reasonable detail for the [***] during the Term and (b) at [***]. ImmunoGen
shall [***] related to each such Research Plan. For Candidate Research Programs
that reach [***], (i) ImmunoGen shall prepare and provide to Jazz’s
representatives on the JRDC a [***] the [***] to [***] from [***] to the point
at which the decision is made to [***], and (ii) ImmunoGen’s representatives on
the JRDC shall [***] into each such [***] the [***] on the JRDC in furtherance
of generating [***] consistent with similar activities undertaken for IMGN632
and IMGN779. The initial Research Plan for each Candidate Research Program
underway as of the Effective Date will be reviewed, discussed, and voted upon by
the JRDC within [***] days after the Effective Date.

3.3.3      Amendments to the Research Plans. Each amendment, modification and
update of a Research Plan shall be set forth in a written document prepared by
ImmunoGen, and shall specifically state that it is an amendment, modification or
update to such Research Plan. ImmunoGen shall provide to the JRDC for review and
approval each initial Research Plan and all material amendments, modifications
and updates to each Research Plan. Without limiting the nature or frequency of
any other amendments, modifications or updates of a Research Plan, ImmunoGen
shall update each Research Plan every [***] months or more often as is
necessary, to

-31-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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describe the research activities to be carried out by ImmunoGen in conducting
each Candidate Research Program (a) in reasonable detail for the [***] during
the Term and (b) at a [***].

3.3.4      Conduct of the Candidate Research Programs. ImmunoGen shall be
responsible for execution of each Research Plan and early stage development of
ADC candidates under each Candidate Research Program, including, in accordance
with the applicable Research Plan, (a) making tactical decisions with respect
thereto, (b) assessing alternative product designs, (c) recommending to the JRDC
the Antibodies, Cytotoxic Compounds and Linkers to be used in the Lead
Candidates and (d) the conduct of all preclinical studies (including dose range
finding and safety studies in animals, and GLP toxicology studies). ImmunoGen
shall conduct all aspects of each Candidate Research Program in accordance with
the applicable Research Plan and Applicable Laws. Notwithstanding the foregoing
or anything to the contrary in this Agreement, [***] shall have the right, for a
period of [***] months following the Effective Date, in lieu of [***] pursuant
to [***], to [***] to [***] a particular Candidate Research Program, in which
case [***] shall [***] such Candidate Research Program. For clarity, if
[***],  in accordance with this Section 3.3 and Section 3.4. At least once
[***], or [***], during the [***] month period following the Effective Date,
ImmunoGen shall provide Jazz with a copy of ImmunoGen’s [***] that [***]
ImmunoGen’s current determination of [***], with the [***] being [***] and the
[***] being [***]; ImmunoGen may [***] that is provided to Jazz to [***] to
those [***] that are [***].

3.4       Selection of New Product. During the Term and only until Jazz has
selected a Candidate to become the New Product, ImmunoGen shall generate [***]
for each Candidate Research Program at the time that the applicable Lead
Candidate [***] and is otherwise [***], and ImmunoGen shall promptly provide to
Jazz [***] generated during the Funding Term, each for Jazz’s consideration
whether to select the applicable Lead Candidate as the New Product. ImmunoGen
shall provide Jazz with an Early Research Program Data Package pursuant to
Section 3.2 together with [***]. ImmunoGen shall, until Jazz has selected a New
Product in accordance with this Section 3.4,  [***] to deliver [***] to Jazz
during the Funding Term at [***] to [***] month [***] starting on the Effective
Date, or as otherwise agreed upon in writing by the Parties. ImmunoGen shall
share with Jazz, via JRDC meetings, [***] and [***] for [***] (including [***]
and [***] of the Lead Candidate), and [***]. Within [***] days of the later of:

-32-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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(a) completion of the JRDC meeting following delivery from ImmunoGen to Jazz of
[***] for a particular Candidate Research Program [***] and (b) [***], which
[***], if any, shall be [***] within [***] days of [***] of such [***], Jazz
shall notify ImmunoGen in writing if it wishes to designate the Lead Candidate
from such Candidate Research Program as the New Product. If Jazz provides such
written notification, the designated Lead Candidate will be deemed the New
Product, and ImmunoGen shall implement the Development Plan for such New Product
in accordance with Section 5.1. For the avoidance of doubt, except to the extent
contemplated by [***], ImmunoGen shall have [***] to [***] or [***] any further
[***] about any [***] after Jazz has selected the New Product in accordance with
this Section 3.4.

3.5       [***].

3.5.1      [***]. In the event that, after [***] in accordance with the
Development Plan for [***], the [***] that [***] has [***], then the [***] of
[***] for such [***] by ImmunoGen performing one or more of the following
activities: (a) [***] with the same [***], (b) [***] or [***] with the [***], or
(c) [***] a [***] against the [***]. If the JRDC decides that [***] and [***]
such a [***] is [***], then the JRDC shall determine the [***] of such [***],
the [***] to [***] such [***], and the [***] to [***] with a [***] for such
[***]. ImmunoGen shall initiate such [***] and activities and [***] to [***] and
activities and, upon [***], provide to Jazz [***] for such [***] for [***]. If
Jazz notifies ImmunoGen within [***] days of receiving such [***] of its [***],
then such [***] shall be deemed [***] under this Agreement as [***], and
ImmunoGen shall implement the Development Plan for such [***] in accordance with
[***]. If (i) the JRDC decides that [***] and [***] such [***] for the [***] is
[***], (ii) the JRDC decides that [***] and [***] such [***] for the [***] is
[***] but ImmunoGen is [***] and [***] a [***] for [***] of [***], or (iii)
Jazz, [***] for such [***],  [***] ImmunoGen, within [***] days of [***] such
[***], of [***] to have the [***] by ImmunoGen [***] for [***] pursuant to the
preceding sentence, then the Development Program for [***] will [***], Jazz
shall be [***] to have [***] with respect thereto, and [***] and such [***]
shall each be deemed [***]. For the avoidance of doubt, ImmunoGen shall [***] to
Jazz for [***] pursuant to this Section 3.5.1 if the [***] that [***] and [***]
such [***] is [***].

-33-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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3.5.2      [***]. In the event that, after [***] in accordance with the
Development Plan for [***], the [***] that [***] has [***], then the [***] of a
[***] for such [***] by performing [***]. If the JRDC decides that [***] and
[***] such a [***] is [***], then the JRDC shall determine the [***] of such
[***], the [***] to [***] such [***], and the [***] to [***] with a [***] for
such [***]. ImmunoGen shall initiate such [***] and activities and [***] to
[***] and activities and, upon [***], provide to Jazz [***] for such [***] for
[***]. If Jazz notifies ImmunoGen, within [***] days of receiving such [***], of
its [***], then such [***] shall be deemed [***] under this Agreement as [***],
and ImmunoGen shall implement the Development Plan for such [***] in accordance
with [***]. If Jazz does [***] ImmunoGen, within [***] days of receiving such
[***], of [***] to [***] such [***], then the Development Program for [***], and
all of Jazz’s rights, related to [***] will [***] and Jazz shall be [***] with
respect thereto, and [***] shall be deemed [***]. If (a) the JRDC decides that
[***] and [***] such [***] is [***] or (b) after [***] of the [***] of a [***]
for such [***], the JRDC determines [***] that such [***] has [***] as a result
of [***], then [***] shall be deemed [***] and ImmunoGen shall deliver to Jazz a
[***] for the [***] if any, that has [***] and is otherwise [***] following
[***] described in clause (a) or (b) above, provided that the [***] has [***]
prior to the [***] anniversary of the Effective Date, and Jazz may [***] as
[***]. Following the [***] of such [***] according to the process described for
the [***] of [***] for [***] above, ImmunoGen shall [***] for such [***] in
accordance with [***]. Upon Jazz’s [***] of [***], it shall be deemed to be
[***] for all purposes hereunder, provided,  however, that ImmunoGen shall not
have any obligation to [***] under this Section 3.5.2 with respect to [***] and
Jazz shall [***] under this Section 3.5.2 to [***] or [***] to [***].

3.5.3      For the avoidance of doubt, if [***] or  a [***] following [***] of
the [***], in each case in accordance with the applicable Development Plan, then
such Collaboration Product shall [***] for [***] in accordance with this Section
3.5.

ARTICLE IV
OPTION RIGHTS

4.1       Option Grant. With respect to each Collaboration Product, ImmunoGen
hereby grants to Jazz exclusive options to obtain an exclusive license under the
Licensed Intellectual

-34-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Property for such Collaboration Product in the Territory on the terms set forth
in the License Agreement (the first such option for each Collaboration Product,
a “Jazz Early Stage Option”, the second such option for each Collaboration
Product, a “Jazz Late Stage Option”).

4.2       Jazz Option Period. The Jazz Option Periods shall be determined for
each of the three Collaboration Products as follows:

4.2.1      For [***]: The “[***] Early Stage Option Period” shall commence upon
the Effective Date and shall [***] days after ImmunoGen’s provision to Jazz of
[***] for [***] that [***] to initiate a pivotal trial [***], and the “[***]
Late Stage Option Period” shall commence upon expiration of the [***] Early
Stage Option Period without the Jazz Early Stage Option being exercised for
[***], and shall end [***] days after ImmunoGen’s provision to Jazz of [***]
that [***] to file the first BLA [***]. The [***] Early Stage Option Period and
the [***] Late Stage Option Period shall each be referred to as an “[***] Option
Period”.

4.2.2      For [***]: The “[***] Early Stage Option Period” shall commence upon
the Effective Date and shall end [***] days after ImmunoGen’s provision to Jazz
of [***] for [***]2 that [***] to initiate a pivotal trial [***], and the “[***]
Late Stage Option Period” shall commence upon expiration of the [***] Early
Stage Option Period without the Jazz Early Stage Option having been exercised
for [***], and shall end [***] days after ImmunoGen’s provision to Jazz of [***]
that [***] to file the first BLA [***],  provided, that if [***] is the [***]
for which  in order to [***], the [***] Late Stage Option Period shall include
two option periods: one option period commencing upon expiration of the [***]
Early Stage Option Period without the Jazz Early Stage Option having been
exercised for [***], and ending [***] days after ImmunoGen’s provision to Jazz
of [***] that [***] to file the first BLA [***] (the “First [***] Late Stage
Option Period”) and a second option period commencing upon the date that is
[***] years after the expiration of the First [***] Late Stage Option Period and
ending [***] days after ImmunoGen’s provision to Jazz of [***] that [***] to
file the first BLA [***],  provided that if ImmunoGen receives approval of the
BLA for [***] during the [***] year period after the expiration of the First
[***] Late Stage Option Period, then such second option period shall begin [***]
months after such approval of the BLA and end [***] days after ImmunoGen’s
provision to Jazz of [***] that [***] to file the first BLA [***] and Jazz may
exercise the option during such second option period, if it commenced

-35-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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[***] months after such BLA approval pursuant to this proviso, upon [***]
months’ notice to ImmunoGen (the “Second [***] Late Stage Option Period”). The
[***] Early Stage Option Period and the [***] Late Stage Option Period,
including the First [***] Late Stage Option Period and the Second [***] Late
Stage Option Period, if applicable, shall each be referred to as an “[***]
Option Period”.

4.2.3      For [***]: The “[***] Early Stage Option Period” shall commence
upon  (or [***], as applicable) and shall end [***] days after ImmunoGen’s
provision to Jazz of [***] for [***] that [***] to initiate a pivotal trial
[***], and the “[***] Late Stage Option Period” shall commence upon the
expiration of the [***] Early Stage Option Period without the Jazz Early Stage
Option having been exercised for [***], and shall end [***] days after
ImmunoGen’s provision to Jazz of [***] that [***] to file the first BLA [***].
The [***] Early Stage Option Period and the [***] Late Stage Option Period shall
each be referred to as a “[***] Option Period”.

4.3       Provision of [***].

4.3.1      For each Collaboration Product, promptly after [***] that [***] to
initiate a pivotal trial for, or file the first BLA for, such Collaboration
Product [***] (but in no event longer than [***] months after [***] has been
[***]), ImmunoGen shall [***] and provide to Jazz [***] or [***], respectively,
for such Collaboration Product. Jazz shall promptly notify ImmunoGen if such
[***] is [***] or [***], in which case ImmunoGen shall [***] an [***] that is
[***] and that [***] by Jazz, and the applicable Option Period shall [***] has
been received by Jazz. The Parties shall promptly [***] Jazz may have with
respect to such [***] or [***], as applicable.

4.3.2      During each of the two (2) [***] Option Periods, three (3) [***]
Option Periods, and two (2) [***] Option Periods, Jazz may request in writing
from ImmunoGen [***] for [***], and [***], respectively. Within [***] days
following receipt of such notice, ImmunoGen shall provide [***] to Jazz for the
applicable Collaboration Product. For clarity, (a) ImmunoGen shall [***] to
[***], or [***] to [***] for [***] but it shall [***] to [***] and [***] based
upon [***] to the extent [***] in [***], and (b) the delivery [***] shall [***]
of, or otherwise [***], the applicable Early Stage Option Period or Late Stage
Option Period for such Collaboration Product.

-36-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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4.4       Option Exercise. With respect to each Collaboration Product, Jazz
shall have the right to exercise a Jazz Option, in its sole discretion, at any
time during one of the Jazz Option Periods for such Collaboration Product. Jazz
may exercise a Jazz Option prior to the expiration of the applicable Jazz Option
Period by delivering to ImmunoGen written notice of exercise thereof and a fully
executed License Agreement for the Collaboration Product for which Jazz is
exercising the Jazz Option. Such License Agreement will be [***], except to the
extent that any [***] or [***] with respect to the transaction contemplated by
such License Agreement to the extent set forth in the License Agreement, which
the Parties shall [***] as specified in such License Agreement. Notwithstanding
anything to the contrary in this Agreement, if (a) a [***] to a [***] for [***]
is [***], (b) [***] has a [***] as to [***] is [***] of [***] and the [***], and
(c) within [***] days after the [***], Jazz exercises the Jazz Option with
respect to [***] during the [***], then the [***] under the License Agreement
for [***] shall be [***],  provided that, if Jazz exercises the Jazz Option
pursuant to clause (c), Jazz shall, promptly following the effectiveness of the
License Agreement, take all necessary action under the License Agreement to
[***], in accordance with the terms of the License Agreement, to [***], and
[***] to conduct the Development of the New Product [***] until such time as the
Development Plan is [***] in accordance with the terms of the License Agreement,
provided that for the [***] month period following the exercise of the Jazz
Option, Jazz [***] the Development Plan under the License Agreement [***] there
is a [***] that [***] such [***]. For clarity, if any License Agreement is
terminated pursuant to Section 10.4 or 10.5 of the License Agreement, then the
Jazz Option will be deemed not to have been exercised during the relevant Jazz
Option Period pursuant to this Agreement with respect to the Collaboration
Product that is the subject of such License Agreement and (i) if such License
Agreement was executed by Jazz during the Early Stage Option Period for such
Collaboration Product or in the case of [***] during the First [***] Late Stage
Option Period (if any), then such Collaboration Product shall remain a
Collaboration Product until such time as it becomes a Jazz Product (as a result
of a subsequent exercise of a Jazz Option with respect thereto) or an ImmunoGen
Product in accordance with the terms of this Agreement and (ii) if such License
Agreement was executed by Jazz during the Late Stage Option Period for such
Collaboration Product (which in the case of [***] shall mean the Second [***]
Late Stage Option Period if there was a First [***] Late Stage Option Period)
then such Collaboration Product shall be deemed to be an ImmunoGen Product and
Section 10.3.5 shall apply.

-37-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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4.5       Expiration of Jazz Late Stage Options. If Jazz fails to exercise any
Jazz Late Stage Option prior to the expiration of the applicable Jazz Option
Period (each, an “Expired Jazz Option”), then the Collaboration Product covered
by the Expired Jazz Option shall be deemed to be an ImmunoGen Product; provided,
 however, that if there is a First [***] Late Stage Option Period, then the Jazz
Late Stage Option Period for [***] shall not expire until the expiration of the
Second [***] Late Stage Option Period and [***] shall not be deemed to be an
ImmunoGen Product until the expiration of the Second [***] Late Stage Option
Period. For clarity (a) this Section 4.5 does not apply to any Collaboration
Product with respect to which Jazz has exercised the applicable Jazz Early Stage
Option, and (b) if Jazz fails to exercise any Jazz Early Stage Option prior to
the expiration of the applicable Jazz Option Period, the applicable
Collaboration Product shall remain a Collaboration Product and Jazz shall have
the right to exercise a Jazz Late Stage Option with respect thereto unless Jazz
exercises a Jazz Opt-Out for such Collaboration Product pursuant to Section
6.2.4.

4.6       [***]. If [***] is [***] for which ImmunoGen completes or has
completed all pivotal trials required by the FDA to file a BLA for [***] and
[***] for [***] during both the [***] Early Stage Option Period and the First
[***] Late Stage Option Period, then [***] may [***], and [***] in [***], in
each case for [***] for [***]. Following [***] of any such [***] in a [***] or
any [***] that includes [***],  [***] may [***] in [***] in such country or
jurisdiction at its sole cost and expense, and [***];  provided, that [***] may
[***] with a [***] or [***] with a [***] for the commercialization of [***] the
Second [***] Late Stage Option Period expires without Jazz exercising its Jazz
Option. Regardless whether [***] any such [***] for [***] for [***] or [***] for
[***] following [***], ImmunoGen shall continue development of [***] in
accordance with the Development Plan, and Jazz may exercise its Jazz Late Stage
Option for [***] during the Second [***] Late Stage Option Period. If Jazz
exercises its Jazz Late Stage Option for [***] during the Second [***] Late
Stage Option Period, then ImmunoGen shall promptly transfer to Jazz [***]
pursuant to [***], and within [***] days after such exercise, ImmunoGen [***],
by written notice to Jazz, to [***] in [***],  provided that ImmunoGen is [***]
in such [***] as of the date of Jazz’s exercise of such Jazz Late Stage Option:
[***] and if ImmunoGen [***] during such [***]day period, then [***] shall be
treated as [***] in the [***] (and the [***] shall be [***]). If ImmunoGen [***]
in which ImmunoGen [***] as of the date of Jazz’s exercise of such Jazz Late

-38-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Stage Option, then ImmunoGen shall promptly transfer to Jazz all of ImmunoGen’s
[***] in [***], and Jazz shall [***] develop and commercialize [***] in all such
countries for all indications pursuant to the [***] License Agreement.
Regardless whether ImmunoGen [***] as of the date of Jazz’s exercise of such
Jazz Late Stage Option, ImmunoGen shall promptly transfer to Jazz all of
ImmunoGen’s [***] (a) in [***] as of the date of Jazz’s exercise of such Jazz
Late Stage Option and (b) in [***], and Jazz shall [***] develop and
commercialize [***] in [***] for all indications pursuant to the [***] License
Agreement. For the avoidance of doubt, if [***] pursuant to this Section 4.6,
then [***] shall [***] from [***], and, if [***], then [***] and [***] shall
[***].

ARTICLE V
DEVELOPMENT AND MANUFACTURING

5.1       Development of Collaboration Products.

5.1.1      Objectives of the Development Programs. The objectives of each
Development Program are to develop the applicable Collaboration Product (i.e.,
IMGN779, IMGN632 [***], or the New Product [***]) to obtain data sufficient to
initiate a pivotal trial [***] with respect to such Collaboration Product (at
which point Jazz may exercise its Jazz Early Stage Option with respect to such
Collaboration Product for further development and commercialization of such
Collaboration Product as a Jazz Product under a License Agreement) and, if Jazz
does not exercise its Jazz Early Stage Option, to further develop the applicable
Collaboration Product to obtain data sufficient to file a BLA [***] for such
Collaboration Product (at which point Jazz may exercise its Jazz Late Stage
Option with respect to such Collaboration Product for further development and
commercialization of such Collaboration Product as a Jazz Product under a
License Agreement).

5.1.2      Development Under the Development Plans. Commencing on the Effective
Date and continuing with respect to each Collaboration Product until the
earliest to occur of (i) the exercise of the Jazz Option, (ii) the exercise of
the Jazz Opt-Out, and (iii) the expiration of the last Jazz Option Period, in
each case with respect to such Collaboration Product, ImmunoGen shall perform
the activities as set forth in the Development Plan for such Collaboration
Product and in accordance with the terms and conditions of this Agreement
including Section 5.1.4. Each Development Plan shall (A) describe the activities
for each Collaboration Product that are [***]

-39-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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to [***] of such Development Program (1) in [***] for the [***] years and (2) at
[***] for [***] until [***] for such Collaboration Product and (B) specify [***]
for the [***] and [***] for [***] or [***] for the [***] years. The initial
Development Plans for each of IMGN779 and IMGN632 are set forth on Section 1.29
of the Disclosure Letter. All other Development Plans and all amended, modified
or updated Development Plans shall address at least all of the items set forth
in such attached Development Plans in a level of detail that is no less than
such attached Development Plans.

5.1.3      Amendments to the Development Plans. Each proposed amendment,
modification and update of any Development Plan shall be set forth in a written
document prepared by a Party, and shall specifically state that it is a proposed
amendment, modification or update to such Development Plan. Such Party shall
provide to the JRDC all amendments, modifications and updates to each
Development Plan for the JRDC’s review and approval. Without limiting the nature
or frequency of any other amendments, modifications or updates of the
Development Plans, ImmunoGen shall update for the JRDC’s review each Development
Plan on an annual basis or more often as is necessary, to describe the
development activities being, or to be, carried out by ImmunoGen in conducting
such Development Program (a) in [***] for the [***] years during the Term and
(b) at [***] for [***] until [***] for such Collaboration Product. On an annual
basis, ImmunoGen shall also [***] for the [***] and [***] for [***] or [***] for
each Collaboration Product in reasonable detail for the [***] years during the
Term. At each JRDC meeting, ImmunoGen shall provide the JRDC with an update
regarding its progress under each Development Plan.

5.1.4      Conduct of the Development Programs; Diligence. ImmunoGen shall [***]
execute each Development Program as set forth in the Development Plan, including
[***] of the Development Program, as specified in Section 5.1.1,  [***] set
forth in the Development Plan [***] (or in the case of the Development Program
for the New Product, [***] set forth in the Development Plan included in [***]
therefor) or [***] thereof. ImmunoGen shall [***] with respect to the
implementation of the Development Program in accordance with the Development
Plan and Applicable Laws.

-40-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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5.1.5      Regulatory Filings. Prior to Jazz’s exercise of the Jazz Option for a
given Collaboration Product, ImmunoGen shall have regulatory responsibility for
such Collaboration Product, including conducting all meetings with Regulatory
Authorities, and ImmunoGen shall own and hold all Regulatory Filings for such
Collaboration Product. Prior to Jazz’s exercise of the Jazz Option for a given
Collaboration Product, (a) ImmunoGen shall keep Jazz [***], including by [***]
of any [***], regarding ImmunoGen’s [***] and [***] with respect to such
Collaboration Product, including any [***] or [***] and all such [***] and [***]
shall be [***] the Development Plan, (b) ImmunoGen shall provide Jazz with (i)
[***] and [***] and [***] for such Collaboration Product [***] for [***] and
(ii) [***] of such [***], (c) to the extent permitted by Regulatory Authorities,
Jazz shall [***],  provided that [***] does [***] at such time, to have [***] at
the [***] and [***] (or if [***] is anticipated to be [***], the [***] or any
[***] prior to [***]) and [***] and [***] with such [***] or [***] that are
[***] of the Collaboration Product, as well as [***] or [***] regarding the
Collaboration Product occurring [***], and related to, such [***] and [***], and
shall be provided with [***] to [***], and (d) Jazz shall also [***] to [***]
and [***] any [***] with [***] or [***] related to such [***] or [***] that are
[***] to [***] of the Collaboration Product. ImmunoGen shall [***] to such [***]
and [***] with [***] or [***] in [***],  provided Jazz  within [***] Business
Days (or shorter if required by the [***]) of receipt, except for [***] for
[***] for which Jazz will have [***] Business Days to [***] (subject to [***]
upon written agreement by the Parties). Following Jazz’s exercise of the Jazz
Option for a particular Collaboration Product, all responsibility for Regulatory
Filings, associated documentation, and interactions with Regulatory Authorities
shall be transferred to Jazz as set forth in the applicable License Agreement.

5.1.6      Safety Concern.

(a)        Notwithstanding anything in this Agreement to the contrary,
ImmunoGen, as sponsor of the clinical trials to be conducted under each
Development Plan under this Agreement, shall have the unilateral right to
terminate any clinical trial conducted under this Agreement immediately for good
faith safety concerns. ImmunoGen shall provide written notice to Jazz upon
termination of any clinical trial conducted pursuant to this Agreement.

-41-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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(b)       If [***], then  shall [***] to a [***] for a [***], which [***] may
(upon mutual agreement of the Parties) include [***] for such trial. [***] shall
[***] each within [***] days after  and such [***] shall [***] within [***] days
thereafter. The [***] shall [***]. The [***] shall [***] in [***] so that each
Party may [***]. The [***] shall, within [***] days after the [***] describing
the [***] and [***] of the [***]. Each Party shall [***], and [***] arising out
of the [***] described in this Section 5.1.6(b), and shall [***] of the [***]
and [***] of the [***] and [***] related to the [***]. Unless the Parties
otherwise agree in writing, during the period of time that any [***] is [***]
under this Agreement, the Parties shall continue to comply with all those terms
and provisions of this Agreement that are [***] of the [***] of the [***].

(c)        If the [***] that ImmunoGen [***], and [***], ImmunoGen is [***] of
the Collaboration Product [***] covered by the [***], then  of the Collaboration
Product [***] and, if [***], the Parties’ rights and obligations with respect to
the related Collaboration Product shall be as specified in [***].

(d)       If the [***] that [***], then [***] the Development Program for the
applicable Collaboration Product to [***] of such Collaboration Product [***].
If the Parties [***] to [***] to the Development Program, then ImmunoGen shall
conduct such [***] Development Program pursuant to the terms of this Agreement.
If (i) [***] Development of such Collaboration Product under [***] Development
Program that [***] and [***] as to [***] Development Program is [***] or (ii) if
[***] development of such Collaboration Product [***], then in either such case
[***] of such Collaboration Product under a development Program [***], and, if
[***], the Parties shall [***] to [***] and if the [***] that it is [***] the
Development Program [***], the Parties’ rights and obligations with respect to
the related Collaboration Product shall be as specified in [***],  provided that
if [***], the Parties’ rights and obligations with respect to the related
Collaboration Product shall be as specified in [***].

5.1.7      Combination Trials. Pursuant to the Development Plan, where the
Parties anticipate that there will be a preclinical or clinical study testing a
Collaboration Product in combination with Vyxeos (such study, a “Combination
Trial”), the Parties shall negotiate in good faith a separate agreement (the
“Combination Trial Agreement”) that specifies the Parties’ rights and
obligations with respect to such Combination Trials, which shall include the
terms and

-42-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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conditions set forth on Schedule D attached hereto and other mutually-agreed,
commercially reasonable terms that are customary for an agreement of such type.

5.2       [***]. If (a) [***] is [***] with respect to the Development Plan for
any particular Collaboration Product, including [***] set forth in [***], then,
(i) if such [***] after the [***] pursuant to [***], and [***] does [***] such
[***] within [***] days of [***], or (ii) [***] such [***] within [***] days of
receiving such [***],  [***] been determined by the [***] under [***] to have
[***] such [***], and [***] to [***] within [***] days after such determination,
or (b) if [***] applies or [***] applies, then [***] may, within [***] days of
the occurrence of the events in clauses (i) or (ii), [***] and, if [***], then:

5.2.1      the [***] obligation under [***] will [***] of the [***] set forth in
[***] for the remainder of such Calendar Year and for each subsequent Calendar
Year during the Funding Term;

5.2.2      if [***] after the [***] for such Collaboration Product, then [***]
pursuant to [***] with respect to such Collaboration Product will [***];

5.2.3      [***] will be deemed to have [***] with respect to such Collaboration
Product;

5.2.4      such Collaboration Product will be [***] and the Parties shall [***]
with respect to such [***] as if [***] (A) the [***] for such Collaboration
Product pursuant to [***] if [***] made [***] before the [***] or (B) the [***]
for such Collaboration Product pursuant to [***] if [***] made [***] after the
[***], and the [***] will [***] to reflect the provisions of Sections [***], and
[***];

5.2.5      [***] shall [***] to [***] pursuant to [***] for [***];

5.2.6      [***] shall  of all [***] for [***];

5.2.7      [***] shall [***] for [***] of all [***] pursuant to Section 5.2.6,
which [***] may [***] (A) to the [***] set forth in  with respect to [***],
which shall otherwise [***]

-43-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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subject to [***], and (B) to the extent [***], to the [***] set forth in  with
respect to [***], which shall otherwise  subject to [***];

5.2.8      following the expiration of the applicable time period set forth in
[***], the Parties’ obligations with respect to [***] in connection with the
[***] of [***] shall be as specified in [***], except that [***] shall [***] of
such [***] pursuant to [***] and [***] shall [***] of such [***] pursuant to
[***];

5.2.9      subject to the [***] described in [***] shall [***] of the [***] set
forth in [***] with respect to [***];

5.2.10    subject to any [***] described in [***],  [***] shall [***] for [***]
pursuant to the terms and conditions of [***] for [***] (including [***]
specified in [***]), provided,  however, that if the [***] or [***] occurs [***]
in the case of [***], (b) [***] in the case of [***], or (c) [***] in the case
of [***], then in each case [***] shall be [***] (and [***] described in [***]
shall [***]); and

5.2.11    [***] may [***] for the [***] for which [***] to [***] pursuant to
[***].

For clarity, [***] can [***] and [***], in accordance with [***], the [***].
 The [***] listed in this [***] shall be [***] and [***] for the applicable
[***] of its [***] with respect to [***] for [***], including the [***] set
forth in [***], for which [***] the [***] in [***]. Notwithstanding the
foregoing, nothing contained herein shall affect [***] under any circumstances
to [***], to [***], or to [***].

5.3      [***].  If (a) [***] to [***] proposed by [***] is [***] by [***] in
accordance with [***] and [***] has [***] as to [***] or (b) if [***] applies,
then [***] of the applicable Collaboration Product, and, if [***], then:

5.3.1      if [***] of such Collaboration Product after [***] for such
Collaboration Product, then [***] pursuant to [***] with respect to such
Collaboration Product will [***];

5.3.2      [***] with respect to such Collaboration Product;

-44-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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5.3.3      such Collaboration Product will be [***] and the Parties shall [***]
with respect to such [***] as if [***] (A) [***] for such Collaboration Product
pursuant to [***] if [***] or (B) [***] for such Collaboration Product pursuant
to [***] if [***], and the [***] will be [***] to reflect the provisions of
Sections [***] and [***];

5.3.4      [***] shall [***] of the [***] for such Collaboration Product and
[***] may, in its discretion, (A) [***] (and [***] shall [***] within [***] days
after the date of [***]) or (B) [***] would otherwise [***];

5.3.5      [***] shall [***] for [***] of [***] for [***], which [***] may [***]
(A) to the applicable [***] in [***] for such [***], which will be [***] days
after, (1) in the case of  as well as [***] to be [***] for [***] or (2) in the
case of [***],  [***] as well as [***] to be [***] for [***], (B) to the extent
[***] by the [***], to the [***] set forth in [***] with respect to such [***],
which shall otherwise [***], and (C) to the extent [***] by the [***], to the
[***] set forth in [***] with respect to such [***], which shall otherwise
[***];

5.3.6      following the expiration of the applicable time period set forth in
[***], the Parties’ obligations with respect to [***] in connection with the
[***] of [***] shall be as specified in [***]; and

5.3.7      subject to any [***] that may be [***] in accordance with [***] shall
[***] and [***] to [***] for [***] pursuant to the terms and conditions of [***]
for [***].

For clarity, if [***], it can [***] in accordance with [***], and it [***] that
was [***] when [***] in accordance with [***].

5.4       Manufacturing; Supply of Materials.

5.4.1      Prior to Jazz’s exercise of the Jazz Option for a given Collaboration
Product [***], ImmunoGen shall manufacture or have manufactured and supply such
Collaboration Product and shall manufacture or have manufactured all materials
(including all Antibodies, Linkers, Cytotoxic Compounds, and ADCs), directly or
through Affiliates or Third Parties, to enable ImmunoGen to conduct such
Development Program. ImmunoGen shall promptly notify

-45-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Jazz of any [***] of the Collaboration Product or to produce Collaboration
Product [***]. ImmunoGen shall also share with the JRDC the [***].

5.4.2      For any agreements between ImmunoGen and a Third Party contract
manufacturing organization relating to a Collaboration Product or any components
thereof, including supply agreements and quality technical agreements, (each, a
“CMO Agreement”) entered into by ImmunoGen [***], ImmunoGen . [***] under this
Section 5.4.2 as [***] shall apply with respect thereto. ImmunoGen [***] shall
include (i) an [***] for the applicable Third Party contract manufacturing
organization to [***], (ii) the [***] for ImmunoGen to [***], to the extent, and
solely to the extent that the CMO Agreement [***] or (iii) an [***] for such
Third Party to [***], pursuant to which [***] with respect to the applicable
Collaboration Product [***].

5.4.3      Upon Jazz’s request at any point after the delivery of an Early Stage
Option Data Package, Late Stage Option Data Package, or Interim Data Package
with regard to a Collaboration Product, the Parties shall discuss in good faith
a plan to perform (either directly or via the applicable ImmunoGen contract
manufacturing organization) technology transfers to Jazz, its Affiliate, or
Permitted Third Party Service Provider (as defined in the License Agreement) as
contemplated by Section 5.2 of the License Agreement.

5.5       Exclusivity.

5.5.1      IMGN Obligations. During the Term, except for research and
development of [***] pursuant to this Agreement or a License Agreement,
ImmunoGen and its Affiliates shall not, either directly or indirectly through a
Third Party, research, develop, or commercialize any [***] Targeting CD33,
CD123, the New Product Target [***],  provided that the foregoing shall no
longer apply with respect to the Target of any ImmunoGen Product commencing at
the following time (as applicable): (a) if it became an ImmunoGen Product
pursuant to Section 1.55(a), upon the expiration of the last Jazz Option without
exercise, (b) if it became an ImmunoGen Product pursuant to Section 3.5.1 or
3.5.2, the earlier of (X) [***] years after the date that it is deemed to be an
ImmunoGen Product pursuant to Section 3.5.1 or 3.5.2 and (Y) the end of the
Term, (c) such ImmunoGen Product is IMGN779 and it became an ImmunoGen Product
pursuant to Section 6.2.4 following ImmunoGen’s termination of its clinical
development as a result of

-46-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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safety or efficacy concerns, the earlier of (X) [***] years after the Jazz
Opt-Out and (Y) the end of the Term, and (d) if it became an ImmunoGen Product
pursuant to Section 6.2.4 and subsection (c) does not apply, (i) with respect to
such ImmunoGen Product, upon the Jazz Opt-Out and (ii) with respect to all other
products Targeting the Target of such ImmunoGen Product, the earliest of (A)
[***] years after the Jazz Opt-Out, (B) [***] and (C) the end of the Term.

5.5.2      Jazz Obligations. During the Term, Jazz and its Affiliates shall not,
either directly or indirectly through a Third Party, research, develop, or
commercialize any [***] that Targets CD33, CD123, the New Product Target [***]
(a “Competing Product”), provided that the foregoing shall (a) not restrict the
ability of Jazz or its Affiliates to participate in any Vyxeos Third Party
Combination Trial, use data from any Vyxeos Third Party Combination Trial to
file an application with any Regulatory Authority for an expanded label for
Vyxeos, or to sell under an approved label Vyxeos or any other product that is
not a Competing Product and that is proprietary to Jazz and (b) no longer apply
with respect to the Target of (i) any Jazz Product or (ii) any ImmunoGen
Product.

5.5.3      Exceptions. Notwithstanding the foregoing, the restrictions of this
Section 5.5 shall not apply (a) to any Future Acquirer of a Party or its
Affiliate that engages in an activity that, if conducted by a Party, would cause
such Party to be in breach of its exclusivity obligations set forth in the
Section 5.5,  provided that such Future Acquirer engages in such activity [***],
or (b) if a Third Party becomes an Affiliate of such Party after the Effective
Date through merger, acquisition, consolidation or other similar transaction
that does not result in a Change of Control of such Party, and as of the closing
date of such transaction, such Third Party is engaged in the research,
development, or commercialization of a product that, if conducted by such Party,
would cause such Party to be in breach of its exclusivity obligations set forth
in this Section 5.5 (a “Competing Program”), then such Party and its new
Affiliate shall have [***] months from the closing date of such transaction to
wind down or complete the Divestiture of such Competing Program, and the conduct
of such Competing Program by such new Affiliate of such Party during such
[***]-month period is not a breach of such Party’s exclusivity obligations in
this Section 5.5;  provided that such new Affiliate conducts such Competing
Program during such [***]-month period independently of the activities of this
Agreement and without use of the proprietary

-47-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

Technology of (i) such Party or (ii) any Person that was an Affiliate of such
Party prior to such transaction. “Divestiture”, as used in this Section 5.5.3,
means the [***] the Competing Program to a Third Party [***] with respect to
[***] in, the [***] of such Competing Program, but, for the avoidance of doubt,
such [***] may include [***]. For clarity, if a Party has Divested a Competing
Program by licensing all rights to the Competing Program and such rights revert
to such Party during the Term (or the term of any applicable License Agreement),
then this Section 5.5.3 shall thereafter apply after such reversion.

5.6       ImmunoGen Opt-In. Except as set forth in [***], ImmunoGen may exercise
the ImmunoGen Opt-In Right under the applicable License Agreement with respect
to one, and only one, Jazz Product within [***] Business Days after being
notified by Jazz of FDA’s acceptance of the filing of the first BLA in the first
indication for such Jazz Product under the applicable License Agreement;
provided,  however, that such ImmunoGen Opt-In Right shall [***]. Until such
time as ImmunoGen has either exercised the ImmunoGen Opt-In Right or the
ImmunoGen Opt-In Right has expired, Jazz shall provide [***] to ImmunoGen for
[***] conducted by Jazz pursuant to a License Agreement for each Jazz Product
promptly following the [***]. Such ImmunoGen Opt-In Right shall be exercised in
accordance with the terms and conditions set forth in Section 7.1 of the
applicable License Agreement. Subject to [***], once ImmunoGen has exercised the
ImmunoGen Opt-In Right with respect to a Jazz Product, such ImmunoGen Opt-In
Right shall not thereafter be exercisable with respect to any other Jazz
Product.

5.7       Burdened Technology.

5.7.1      General. The Parties hereby acknowledge that certain Technology
Controlled by ImmunoGen may be subject to financial or other contractual
obligations to Third Parties incurred by ImmunoGen as a result of an in-license
or similar agreement (“Burdened Technology”), and that the use of Burdened
Technology in the development or commercialization of Collaboration Products or
Jazz Products may (a) result in financial or other contractual obligations of
ImmunoGen to Third Parties, or (b) require that certain notices or disclosures
be made by ImmunoGen to such Third Party as a result of the use thereof
(collectively, the “Burdened Technology Obligations”). [***]

-48-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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5.7.2      Review of Technology. After the Effective Date (or, in the case of
the New Product, after Jazz’s selection of such New Product) and prior to
exercise of the Jazz Option with respect to a Collaboration Product, if
ImmunoGen desires to acquire or in-license Technology related to such
Collaboration Product that would become Burdened Technology as a result of such
acquisition or in-license, then ImmunoGen shall [***] and, subject to [***] from
the [***] of such [***] (which ImmunoGen shall [***]), shall [***] the [***] of
such [***],  provided that ImmunoGen shall [***] ImmunoGen will [***] such
Burdened Technology, and to [***], and such decision by ImmunoGen shall [***] on
any [***] by [***] from ImmunoGen in connection with its exercise of a Jazz
Option or to [***] or [***] such Technology from a Third Party. ImmunoGen shall
notify Jazz promptly upon becoming aware of any Technology that arises from a
material transfer or similar agreement entered into by ImmunoGen pursuant to
which ImmunoGen provides a Third Party with access to a Collaboration Product
(or the Antibody contained in a Collaboration Product) to a Third Party for
[***] and shall discuss with Jazz [***]. If ImmunoGen [***], it shall [***] with
respect thereto. If ImmunoGen [***], then it shall [***] and not less than [***]
days before [***].

5.7.3      Responsibility for Burdened Technology Obligations. ImmunoGen shall
be responsible for [***] of payments to Third Parties for Burdened Technology
related to a Collaboration Product prior to exercise of the Jazz Option for such
Collaboration Product. Thereafter, as between the Parties, responsibility for
such Burdened Technology Obligations shall be as set forth in the applicable
License Agreement.

ARTICLE VI
FINANCIAL TERMS

6.1       Upfront Fee. In consideration of the grant of the Jazz Option set
forth Section 4.1, Jazz hereby agrees to pay ImmunoGen an upfront fee (the
“Upfront Fee”) in the amount of Seventy-Five Million U.S. Dollars ($75,000,000)
payable in accordance with Section 6.3 within [***] days after the Effective
Date, which Upfront Fee shall be non-refundable and non-creditable.

6.2       Research and Development Funding.

6.2.1      Funding Obligations.

-49-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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(a)        ImmunoGen shall bear all ImmunoGen Development Costs except to the
extent reimbursed by Jazz pursuant to this Section 6.2.1. Subject to Sections
5.2,  5.3,  6.2.2,  6.2.3, and 6.2.4, during the Funding Term, Jazz herby agrees
to pay ImmunoGen up to a total of One Hundred Million U.S. Dollars
($100,000,000) in development funding (the “Jazz Development Funding”) to
reimburse for ImmunoGen Development Costs. Jazz shall reimburse ImmunoGen for
fifty percent (50%) of the ImmunoGen Development Costs on a Calendar Quarterly
basis in arrears based on activity during such Calendar Quarter, within thirty
(30) days of receipt of an invoice from ImmunoGen for fifty (50%) of the
ImmunoGen Development Costs in accordance with Section 6.2.2 and Section 6.3, up
to the Jazz Development Funding Cap for each Calendar Year (or portion thereof)
within the Funding Term set forth in the chart below (each, a “Jazz Development
Funding Cap”).

 

 

Calendar Year (or portion thereof) within the Funding Term

Jazz Development Funding Cap

First partial Calendar Year (that portion of 2017 starting from the Effective
Date and ending at the end of such Calendar Year)

[***]

Second Calendar Year (2018)

[***]

Third Calendar Year (2019)

[***]

Fourth Calendar Year (2020)

[***]

Fifth Calendar Year (2021)

[***]

Sixth Calendar Year (2022)

[***]

Seventh Calendar Year (2023)

[***]

Eighth partial Calendar Year (that portion of 2024 up to the seventh anniversary
of the Effective Date).

[***]

 

Under no circumstances shall the total of all Jazz Development Funding Caps for
all Calendar Years within the Funding Term exceed one hundred million U.S.
Dollars ($100,000,000).

(b)       The Jazz Development Funding shall reimburse ImmunoGen solely for up
to [***] of the ImmunoGen Development Costs incurred to perform activities set
forth in

-50-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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the Development Plans. Except as provided otherwise in this Agreement, if [***]
of the ImmunoGen Development Costs in a given Calendar Year exceed the Jazz
Development Funding Cap for such Calendar Year, ImmunoGen shall solely bear such
excess ImmunoGen Development Costs and Jazz shall not have any obligation to
reimburse ImmunoGen for such excess ImmunoGen Development Costs. In addition,
ImmunoGen shall solely bear all ImmunoGen Development Costs incurred after the
end of the Funding Term and Jazz shall not have any obligation to reimburse
ImmunoGen for any such ImmunoGen Development Costs. ImmunoGen’s development
obligations hereunder shall not be reduced because the ImmunoGen Development
Costs exceed the applicable Jazz Development Funding Cap or are incurred after
the end of the Funding Term.

6.2.2      Cost Summary. ImmunoGen shall provide Jazz with a good faith,
non-binding estimate of ImmunoGen Development Costs incurred or to be incurred
by ImmunoGen for each Calendar Quarter [***] days before the end each Calendar
Quarter. Within [***] days following the last day of each Calendar Quarter
during the Funding Term, ImmunoGen shall provide to Jazz a summary (each, a
“Cost Summary”) of the ImmunoGen Development Costs actually incurred by
ImmunoGen during such Calendar Quarter, such ImmunoGen Development Costs to be
reported on a Development Program-by-Development Program basis, and a related
invoice for [***] of such ImmunoGen Development Costs. The Cost Summary shall
include all appropriate back-up documentation, including [***]. Within [***]
days from the date of its receipt of each such invoice, Jazz will pay to
ImmunoGen the invoice amount due as Jazz Development Funding for the ImmunoGen
Development Costs, subject to the applicable Jazz Development Funding Cap. If
Jazz disputes any charge contained in an invoice, it will pay any undisputed
amount in accordance with the preceding sentence, and the disputed amount will
be addressed under the dispute resolution provisions of Section 13.13.

6.2.3      Option Extension Funding. If a Collaboration Product achieves
completion of the clinical study that supports a good faith decision to initiate
a pivotal trial in AML or MDS (or, with respect to the New Product, an oncology
indication of  to [***]) and (i) Jazz does not exercise a Jazz Option with
respect to such Collaboration Product during the respective IMGN779 Early Stage
Option Period, IMGN632 Early Stage Option Period, or New Product Early Stage

-51-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Option Period, (ii) Jazz has not been deemed to have exercised the Jazz Option
with respect to such Collaboration Product pursuant to Sections 5.2 or 5.3, and
(iii) Jazz has not provided notice of exercise of a Jazz Opt-Out with respect to
such Collaboration Product pursuant to Section 6.2.4, then, for each such
Collaboration Product, Jazz shall pay ImmunoGen a Jazz Option extension fee of
[***] per year for up to the next [***] consecutive twelve- [***] for a total
payment of up to [***]. The first such Jazz Option extension fee for a
particular Collaboration Product shall be paid within [***] days after the
beginning of the next Calendar Quarter after the Calendar Quarter in which the
IMGN779 Early Stage Option Period, IMGN632 Early Stage Option Period, or New
Product Early Stage Option Period, as applicable, expires without exercise of
the Jazz Option, and the subsequent extension fees shall be due on the [***],
respectively, of such date, provided in each case that clauses (ii) and (iii) of
this Section 6.2.3 are still met as of such anniversary and that Jazz has not
exercised the Jazz Option with respect to such Collaboration Product by such
anniversary, and if clause (ii) or (iii) of this Section 6.2.3 is not met as of
such anniversary, then Jazz’s obligation to pay the Option extension fee
pursuant to this Section 6.2.3 shall be waived.

6.2.4      Jazz Opt-Out.

(a)        Jazz shall have the right, in its sole discretion, to opt-out of its
(i) rights to select a New Product with respect to the Early Research Programs
and Candidate Research Programs, at any time between [***] anniversary of the
Effective Date and ImmunoGen’s delivery to Jazz of [***], or (ii) financial
rights and responsibilities with respect to a Collaboration Product at any time
during the Funding Term, in each case upon [***] days’ written notice to
ImmunoGen (each of a (i) and (ii), a “Jazz Opt-Out”). Upon ImmunoGen’s receipt
of notice of a Jazz Opt-Out, (1) the Development Program for the applicable
Collaboration Product shall be terminated, (2) the Jazz Option with respect to
such Collaboration Product shall be terminated, (3) for each Jazz Opt-Out
exercised by Jazz, the Jazz Development Funding obligations under to Section
6.2.1 for each Calendar Year of the remainder of the Funding Term shall be
reduced by an amount equal to [***] of the applicable Jazz Development Funding
Cap set forth in Section 6.2.1(a) for such year (as so reduced, the “Revised
Jazz Development Funding Cap”), (4) if Jazz exercises a Jazz Opt-Out with
respect to the Early Research Programs and Candidate Research Programs,
ImmunoGen shall have no further obligation to provide to Jazz any

-52-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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further information about the Early Research Programs and Candidate Research
Programs and Jazz may no longer select a New Product under Section 3.4, (5) if
Jazz exercises a Jazz Opt-Out for a Collaboration Product during or after the
Early Stage Option Period for such Collaboration Product, then Jazz’s funding
obligations pursuant to Section 6.2.3 with respect to such Collaboration Product
will terminate, subject to Section 6.2.4(b), and (6) each Collaboration Product
for which Jazz exercises its Jazz Opt-Out shall be deemed to be an ImmunoGen
Product and, if applicable, ImmunoGen shall pay a royalty to Jazz pursuant to
Section 10.3. For clarity, Jazz may not exercise the Jazz Opt-Out with respect
to the Early Research Programs and Candidate Research Programs if ImmunoGen
delivers to Jazz [***] prior to the [***] anniversary of the Effective Date.

(b)       With respect to any Collaboration Product for which Jazz has exercised
the Jazz Opt-Out (the “Opt-Out Collaboration Product”), if one or more clinical
trials of the Opt-Out Collaboration Product are ongoing at the time Jazz
delivers notice of such Jazz Opt-Out to ImmunoGen, then, subject to the
applicable Jazz Development Funding Cap in effect immediately prior to Jazz’s
delivery of notice of the Jazz Opt-Out to ImmunoGen, Jazz shall reimburse
ImmunoGen for up to [***] of the ImmunoGen Development Costs incurred to (i)
responsibly wind-down such clinical trial if ImmunoGen elects not to continue
such clinical trial or (ii) conduct such ongoing clinical trials in accordance
with the Development Plan during the [***] day notice period for the applicable
Jazz Opt-Out and the [***] day period immediately following such [***] day
notice period if ImmunoGen elects to continue such clinical trial. For purposes
of clarity, ImmunoGen’s right to receive Jazz Development Funding with respect
to the Development Programs relating to the Collaboration Products for which
Jazz has not exercised the Jazz Opt-Out shall be subject to the Revised Jazz
Development Funding Cap.

6.2.5      Research Funding. ImmunoGen shall be solely responsible for all costs
associated with conducting the Early Research Programs and Candidate Research
Programs, and Jazz shall not have any obligation to reimburse ImmunoGen
therefor.

6.3       Payment Terms.

-53-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

6.3.1      No-Set-Off; Tax Withholding. All payments made by Jazz to ImmunoGen
hereunder shall be made without set-off or counterclaim and free and clear of
any taxes, duties, levies, fees or charges, except for withholding taxes, if
any. Jazz shall make any applicable withholding payments due on behalf of
ImmunoGen and shall provide ImmunoGen with reasonable proof of payment of such
withholding taxes, together with an accounting of the calculations of such
taxes, within [***] days after such payment is remitted to the proper authority.
Any withheld tax remitted by Jazz to the proper authority shall be treated as
having been paid by Jazz to ImmunoGen for all purposes of this Agreement. The
Parties shall cooperate reasonably in completing and filing documents required
under the provisions of any Applicable Laws in connection with the making of any
required withholding tax payment, or in connection with any claim to a refund of
or credit for any such payment.

6.3.2      Wire Transfers. All payments hereunder shall be made to ImmunoGen in
U.S. Dollars by bank wire transfer in immediately available funds to the account
designated by ImmunoGen by written notice from time to time.

6.4       Overdue Payments. Subject to the other terms of this Agreement, any
payments hereunder not paid within the applicable time period set forth herein
shall bear interest from the due date until paid in full, at a rate per annum
equal to the lesser of (a) [***], or (b) the maximum interest rate permitted by
Applicable Law in regard to such payments, calculated in each case from the date
such payment was due through to the date on which payment is actually made;
provided,  however, that with respect to any disputed payments, no interest
payment is due until such dispute is resolved and the interest payable thereon
will be based on the finally resolved amount of such payment, calculated from
the original date on which the disputed payment was due through the date on
which payment is actually made. Such interest and the payment and acceptance
thereof shall not negate or waive the right of a Party to any other remedy,
legal or equitable, to which it may be entitled because of the delinquency of
the payment.

6.5       Records Retention; Audit.

6.5.1      Records Retention. ImmunoGen shall keep for at least [***] years from
the end of the Calendar Year to which they pertain complete and accurate records
of the ImmunoGen

-54-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Development Costs incurred hereunder and any other costs and expenses of
ImmunoGen that are to be borne or reimbursed by Jazz hereunder in sufficient
detail to allow the accuracy of the amounts charged to Jazz to be confirmed.

6.5.2      Audit. Subject to the other terms of this Section 6.5.2, at the
request of Jazz, upon at least [***] Business Days’ prior written notice, but no
more often than [***] per Calendar Year and not more frequently than [***] with
respect to records covering any specific period of time, and at Jazz’s sole
expense (except as otherwise provided herein), ImmunoGen shall permit an
internationally recognized independent accounting firm [***] to inspect (during
regular business hours) at such place or places where such records are
customarily kept the relevant records required to be maintained by ImmunoGen
under Section 6.5.1. At Jazz’s request, the independent accounting firm may
audit the then-preceding [***] years of ImmunoGen’s records solely for purposes
of verifying ImmunoGen’s calculation of ImmunoGen Development Costs and any
other costs and expenses of ImmunoGen that are to be borne or reimbursed by Jazz
hereunder during the period subject to review. Before beginning the audit the
independent accounting firm shall enter into a confidentiality agreement with
both Parties substantially similar to the provisions of Article VII limiting the
disclosure and use of such information by such independent accounting firm to
authorized representatives of the Parties and the purposes germane to this
Section 6.5.2. The independent accounting firm shall provide its audit report
and basis for any determination to ImmunoGen at the time such report is provided
to Jazz. The Parties shall each have the right to request a further
determination by such independent accounting firm as to matters which such Party
disputes within [***] days following receipt of such report. The Party
initiating a dispute will provide the other Party and the independent accounting
firm with a reasonably detailed statement of the grounds upon which it disputes
any findings in the audit report and the independent accounting firm shall
undertake to complete such further determination within [***] days after the
dispute notice is provided, which determination shall be limited to the disputed
matters and provided to both Parties. The Parties shall use reasonable efforts,
through the participation of finance representatives of both Parties, to resolve
any dispute arising in relation to the audit by good faith discussion. The
results of any such audit, reflecting the independent accounting firm’s
determination of any disputed matters, shall be binding on both Parties, absent
manifest error. Jazz agrees to treat the results of any such independent
accounting firm’s review

-55-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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of ImmunoGen’s records under this Section 6.5.2 as Confidential Information of
ImmunoGen subject to the terms of Article VII. If any such audit reveals an
inaccuracy in the calculation of ImmunoGen Development Costs or other amounts
resulting in any overpayment by Jazz, ImmunoGen shall refund the amount of any
such overpayment, and if such overpayment is by [***] or more of the amount due,
ImmunoGen shall pay the reasonable costs and expenses of conducting the audit.
If any audit reveals an inaccuracy in the calculation of ImmunoGen Development
Costs resulting in an underpayment by Jazz, ImmunoGen may invoice Jazz for such
underpayment, and Jazz will pay such invoice within [***] days from the date of
its receipt of such invoice, in accordance with Section 6.3.

ARTICLE VII
TREATMENT OF CONFIDENTIAL INFORMATION

7.1       Confidentiality.

7.1.1      Confidentiality Obligations. ImmunoGen and Jazz each recognizes that
the other Party’s Confidential Information constitutes highly valuable assets of
such other Party. ImmunoGen and Jazz each agrees that, subject to Section 7.1.2,
during the Term and for an additional [***] years thereafter, (a) it shall not
disclose, and shall cause its Affiliates (and in the case of ImmunoGen, it shall
contractually obligate its subcontractors) not to disclose, any Confidential
Information of the other Party and (b) it shall not use, and shall cause its
Affiliates (and in the case of ImmunoGen, it shall contractually obligate its
subcontractors) not to use, any Confidential Information of the other Party, in
either case, except as expressly permitted hereunder. Without limiting the
generality of the foregoing, each Party shall take such action, and shall cause
its Affiliates (and in the case of ImmunoGen, it shall contractually obligate
its subcontractors) to take such action, to preserve the confidentiality of the
other Party’s Confidential Information as such Party would customarily take to
preserve the confidentiality of its own Confidential Information and shall, in
any event, use at least reasonable care to preserve the confidentiality of the
other Party’s Confidential Information. The Parties shall use adequate and
diligent efforts, consistent with each Party’s past practices but no less than a
reasonable degree of care, to preserve and protect the confidential nature of
its Confidential Information. On a Collaboration Product-by-Collaboration
Product basis, promptly following the earlier of the date

-56-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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on which: (i) all Jazz Options have expired unexercised with respect to such
Collaboration Product, and (ii) Jazz exercises the Jazz Opt-Out with respect to
such Collaboration Product, Jazz shall return to ImmunoGen or destroy all
Confidential Information of ImmunoGen related to such Collaboration Product.

7.1.2      Limited Disclosure. Each Receiving Party may disclose the Disclosing
Party’s Confidential Information to its Affiliates and their respective
Representatives to enable the Receiving Party to exercise its rights or to carry
out its responsibilities under this Agreement, provided that such disclosure
shall only be made to Persons who are bound by written obligations at least as
stringent as those described in Section 7.1.3, or, in the case of third party
investors or potential acquirors, who are bound by written obligations
consistent with industry standards and in any event not less than [***] years.
In addition, the Receiving Party may disclose the Disclosing Party’s
Confidential Information to the extent such disclosure is required by Applicable
Laws, provided that in the case of any such disclosure, the Receiving Party
shall (A) if practicable, provide the Disclosing Party with reasonable advance
notice of and an opportunity to comment on any such required disclosure, (B) if
requested by the Disclosing Party, cooperate in all reasonable respects with the
Disclosing Party’s efforts to obtain confidential treatment or a protective
order with respect to any such disclosure, at the Disclosing Party’s expense,
and (C) use good faith efforts to incorporate the comments of the Disclosing
Party in any such disclosure or request for confidential treatment or a
protective order.

7.1.3      Employees, Consultants and Subcontractors. ImmunoGen and Jazz each
hereby represents and warrants that all of its and its Affiliates’
Representatives who participate in the activities contemplated by this Agreement
or who otherwise have access to Confidential Information of the other Party are
or will, prior to their participation or access, be bound by written obligations
to maintain such Confidential Information in confidence and not to use such
information except as expressly permitted hereunder. Each Party agrees to use,
and to cause its Affiliates (and in the case of ImmunoGen, its subcontractors)
to use, reasonable efforts to enforce such obligations.

7.2       Publicity.

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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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7.2.1      Terms of Agreement. The Parties acknowledge that the terms of this
Agreement constitute the Confidential Information of each Party and may not be
disclosed except as permitted by Section 7.1 and this Section 7.2. Either Party
may disclose the terms of this Agreement (a) on a need-to-know basis to such
Party’s legal, accounting and financial advisors and (b) as reasonably necessary
in connection with any actual or potential (i) debt or equity or other financing
of such Party or (ii) purchase by any Third Party of all the outstanding capital
stock or all or substantially all of the assets of such Party or any merger or
consolidation involving such Party; and provided,  further, that in each case
the Person to whom the terms of this Agreement is to be disclosed agrees in
writing to maintain the confidentiality of such information with terms at least
as protective as those contained in Section 7.1 or in the case of Third Party
potential investors, acquirors, lenders or bankers or their representatives, who
are bound by written confidentiality obligations consistent with industry
standards.

7.2.2      Public Announcements. Following execution of this Agreement, the
Parties shall issue the press release as set forth on Schedule C attached
hereto. After issuance of such press release, neither Party shall publish,
present or otherwise disclose publicly any material related to events arising
under this Agreement without the prior written consent of the other Party, which
consent shall not be unreasonably withheld, conditioned or delayed; provided
that notwithstanding the foregoing, (A) neither Party will be prevented from
complying with any duty of disclosure it may have pursuant to Applicable Laws;
and (B) either Party shall be permitted to publish such material in scientific
journals or present such material at scientific conferences in accordance with
Section 7.3. Either Party may make subsequent and repeated public disclosure of
the contents of any disclosures made or permitted by this Section 7.2.2 without
the prior written consent of the other Party.

7.2.3      Legal Disclosures. Notwithstanding the terms of this Article VII,
either Party may disclose the existence and terms of this Agreement to the
extent required, in the reasonable opinion of such Party’s legal counsel, to
comply with Applicable Laws, including the rules and regulations promulgated by
the United States Securities and Exchange Commission (“SEC”) or any other
Governmental Authority. Notwithstanding the foregoing, before disclosing this
Agreement or any of the terms hereof pursuant to this Section 7.2.3, the Parties
will coordinate

-58-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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in advance with each other in connection with the redaction of certain
provisions of this Agreement with respect to any filings with the SEC, the
NASDAQ Stock Market or any other stock exchange on which securities issued by a
Party or a Party’s Affiliate are traded, and each Party shall use commercially
reasonable efforts to seek confidential treatment for such terms as may be
reasonably requested by the other Party; provided that each Party will
ultimately retain control over what information that Party discloses to their
relevant exchange; and provided further that the Parties shall use commercially
reasonable efforts to file redacted versions with any governing bodies that are
consistent with redacted versions previously filed with any other governing
bodies. Other than the foregoing obligation, neither Party (nor its Affiliates)
will be obligated to consult with or obtain approval from the other Party with
respect to any filings to the SEC the NASDAQ Stock Market or any other stock
exchange.

7.3       Publications and Presentations. Jazz agrees that, except as required
by Applicable Laws, it shall not publish or present, or permit to be published
or presented, the design or results of any Candidate Research Program or
Development Program prior to exercise of a Jazz Option. ImmunoGen agrees that,
except as required by Applicable Laws, it shall not publish or present, or
permit to be published or presented, the design or results of any Development
Program without complying with the obligations set forth in this Section 7.3.
ImmunoGen shall provide to Jazz the opportunity to review each of ImmunoGen’s
proposed (a) abstracts and manuscripts for scientific journals or conferences at
least [***] days prior to its intended submission for publication, and (b)
presentations at scientific conferences (including information to be presented
verbally) at least [***] Business Days prior to its intended presentation, in
each case of (a) and (b) that relate to the design or results of any Candidate
Research Program or Development Program. Upon written request from Jazz given
within such applicable review period, ImmunoGen shall remove any Confidential
Information of Jazz that is disclosed in any such proposed publication or
presentation prior to such publication or presentation and shall [***] to file
patent applications to protect any unpatented Technology Controlled by ImmunoGen
that is disclosed in such publication or presentation. Once such abstracts,
manuscripts or presentations have been submitted to Jazz for review and
ImmunoGen has [***] in accordance with the terms of this Section 7.3, the same
abstracts, manuscripts or presentations do not have to be provided again by
ImmunoGen to Jazz for review for a later submission for publication. At Jazz’s
reasonable timely request, in any

-59-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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permitted publication or presentation by ImmunoGen, Jazz’s contribution shall be
duly recognized, and co-authorship shall be determined in accordance with
customary industry standards.

7.4       Integration. As to the subject matter of this Agreement, this Article
VII supersedes any confidential disclosure agreements between the Parties,
including the Confidentiality Agreement. Any confidential information of a Party
under such agreement relating to the subject matter of this Agreement shall be
treated as Confidential Information of such Party hereunder, subject to the
terms of this Article VII.

ARTICLE VIII
INTELLECTUAL PROPERTY

8.1       Ownership of Intellectual Property; License.

8.1.1      Ownership. Except as otherwise expressly provided herein or in the
Combination Trial Agreement, all inventions and discoveries invented, conceived
or developed by or on behalf of a Party or its Affiliates, whether alone or with
the other Party or a Third Party, in conducting activities pursuant to this
Agreement shall be owned by ImmunoGen. For the avoidance of doubt, “activities
pursuant to this Agreement” includes participation in committee meetings and any
other communications between the Parties in connection with this Agreement. In
the event that an employee of Jazz or other Person obligated to assign
inventions to Jazz and its Affiliates invents, conceives or otherwise develops
an invention or discovery in conducting activities pursuant to this Agreement,
alone or with others, Jazz hereby assigns and agrees to assign to ImmunoGen
Jazz’s entire right, title and interest in and to such invention or discovery
and all associated intellectual property rights including Patent Rights claiming
such invention or discovery (all such inventions, discoveries and intellectual
property rights, the “Assigned Intellectual Property”). In each License
Agreement, the Assigned Intellectual Property shall be included in the Licensed
Intellectual Property (as defined in the License Agreement) if it is necessary
or useful to Develop (as defined in the License Agreement), make, have made,
use, sell, offer for sale, import, or otherwise Commercialize (as defined in the
License Agreement) the Licensed Product (as defined in the License Agreement).

-60-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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8.1.2      License. ImmunoGen hereby grants to Jazz a [***] and [***],  [***],
to use and practice the Assigned Intellectual Property (excluding any ADC
Platform Improvements) for [***] under any Early Research Program or Candidate
Research Program. If Jazz provides to ImmunoGen [***], ImmunoGen will [***].

8.2       Patent Filing, Prosecution and Maintenance.

8.2.1      Product Patent Rights. ImmunoGen, acting through patent counsel or
agents of its choice, shall have the sole right to prepare, file, prosecute, and
maintain (including responding to inter partes reviews, post-grant reviews, and
similar oppositions in other jurisdictions) at ImmunoGen’s sole expense all
Product Patent Rights. ImmunoGen shall [***] of all Product Patent Rights.
ImmunoGen shall [***], and ImmunoGen shall [***] relating thereto, including
[***]. ImmunoGen’s obligations and [***] under this Section 8.2.1 with respect
to any particular Product Patent Rights shall terminate on the expiration of all
Jazz Options with respect to all Collaboration Products covered or claimed by
the applicable Product Patent Rights or Jazz’s earlier exercise of its Opt-Outs
with respect to all such Collaboration Products.

8.2.2      [***]. Promptly after the Effective Date, the Parties’ respective
chief patent counsels (or persons serving in the same function), shall discuss
[***] on the Patent Rights Controlled by ImmunoGen as of the Effective Date to
[***]. ImmunoGen, after giving due consideration to such discussions, shall
[***], which shall be deemed to be [***],  provided that ImmunoGen shall be
under no obligation to take any action with respect to [***]. With respect to
new patent filings made during the Term, ImmunoGen shall [***],  provided that
ImmunoGen shall be under no obligation to [***].

8.3       Bankruptcy. All rights and licenses granted under this Agreement are,
and shall be deemed to be, for purposes of Section 365(n) of the United States
Bankruptcy Code, licenses of rights to “intellectual property” as defined under
Section 101(56) of the United States Bankruptcy Code.

ARTICLE IX

TERM AND TERMINATION

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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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9.1       Term. The term of this Agreement shall commence on the Effective Date
and shall continue, subject to earlier termination in accordance with
Section 9.2, until the earlier of the date on which: (i) all Jazz Options have
either been exercised or have expired or terminated unexercised (including
termination of Jazz Options as a result of exercising the Jazz Opt-Out), and
(ii) the Development Programs for IMGN632, IMGN779 and the New Product have all
been terminated by ImmunoGen in accordance with Section 5.1.6 (the “Term”).

9.2       Termination. Subject to the other terms of this Agreement:

9.2.1      Termination for Breach. Either Party may terminate this Agreement,
effective upon written notice to the other Party, upon any material breach by
the other Party of this Agreement that remains uncured [***] days ([***] days if
the breach is a failure by the other Party to make any payment required
hereunder) after the non-breaching Party first gives written notice of such
breach to the other Party describing such material breach in reasonable detail;
provided,  however, that if the nature of the asserted breach (other than a
breach for non-payment) is such that more than [***] days are reasonably
required to cure, then the cure period shall be extended for a period not to
exceed an additional [***] days so long as the Party seeking to cure the
asserted breach is [***]. Anything contained in this Agreement to the contrary
notwithstanding and subject to the proviso of this sentence, if the allegedly
breaching Party (a) disputes either (i) whether a material breach has occurred
or (ii) whether the material breach has been timely cured, and (b) provides
written notice of such dispute to the other Party within the above time periods,
then the matter will be addressed under the dispute resolution provisions of
Section 13.13, and the Party asserting the breach may not terminate this
Agreement until it has been finally determined under Section 13.13 that the
allegedly breaching Party is in material breach of this Agreement, and such
breaching Party further fails to cure such breach within [***] days ([***] days
if the breach is a failure by a Party to make any payment required hereunder)
after the conclusion of the dispute resolution procedure. Anything contained in
this Agreement to the contrary notwithstanding, if the asserted material breach
is cured or shown to be non-existent within the applicable cure period, the
first notice of breach hereunder shall be deemed automatically withdrawn and of
no effect.

9.2.2      Termination for Insolvency. To the extent not prohibited by
Applicable Laws, if either Party files for protection under bankruptcy laws,
makes an assignment for the

-62-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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benefit of creditors, appoints or suffers the appointment of a receiver or
trustee over its property, files a petition under any bankruptcy or insolvency
act or has any such petition filed against it which is not discharged within
sixty (60) days of the filing thereof, then the other Party may terminate this
Agreement effective immediately upon written notice to such Party.

9.3       Consequences of Expiration or Termination. Upon expiration or earlier
termination of this Agreement by either Party under Section 9.2, the following
provisions shall apply:

9.3.1      Expiration or Earlier Termination by ImmunoGen under Section 9.2.1 or
9.2.2. If this Agreement expires in accordance with its terms or is earlier
terminated by ImmunoGen under Section 9.2.1 or 9.2.2, then:

(a)        all unexercised Jazz Options granted by ImmunoGen pursuant to Article
IV shall immediately terminate;

(b)       all Collaboration Products for which a Jazz Option has not been
exercised shall be deemed ImmunoGen Products, and, if applicable, ImmunoGen
shall pay a royalty to Jazz pursuant to Article X; and

(c)        each Party shall promptly return or destroy all Confidential
Information of the other Party, provided that each Party may retain, subject to
Article VII (i) one (1) copy of the Confidential Information of the other Party
in its archives solely for the purpose of establishing the contents thereof and
ensuring compliance with its obligations hereunder, (ii) any Confidential
Information of the other Party contained in laboratory notebooks or databases,
(iii) any computer records or files containing such Confidential Information
that have been created solely by its automatic archiving and back-up procedures,
to the extent created and retained in a manner consistent with its standard
archiving and back-up procedures, but not for any other uses or purposes, and
(iv) any Confidential Information of the other Party to the extent reasonably
required to exercise its rights and perform its obligations under any
outstanding License Agreement. Notwithstanding the foregoing, no License
Agreement executed as of the date of termination of this Agreement shall be
affected by any termination of this Agreement.

-63-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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9.3.2      Termination by Jazz. If this Agreement is terminated by Jazz under
Section 9.2.1 or 9.2.2, then each of the Parties’ obligations pursuant to this
Agreement shall terminate except those that survive pursuant to Section 9.4, all
Collaboration Products for which a Jazz Option has not been exercised shall be
deemed ImmunoGen Products, and ImmunoGen shall pay a royalty to Jazz pursuant to
Article X.

9.3.3      Remedies. Except as otherwise expressly set forth in this Agreement,
the termination provisions of this Section 9.3 are in addition to any other
relief and remedies available to either Party at law or in equity.

9.4       Surviving Provisions. Notwithstanding any provision herein to the
contrary, the rights and obligations of the Parties set forth in Article I (to
the extent used in any surviving provisions), Sections 6.5,  7.1,  7.2,  8.1.1,
 8.1.2,  8.3,  9.3,  9.4,  Article X (for the applicable ImmunoGen Royalty
Term), Section 11.4, and Article XII and Article XIII, as well as any rights or
obligations otherwise accrued hereunder (including any accrued payment
obligations) shall survive the expiration or termination of the Term of this
Agreement, as well as any other provisions that, by their intent or meaning
under the circumstances, are intended to survive. Without limiting the
generality of the foregoing, Jazz shall remain liable for all payment
obligations accruing hereunder prior to the effective date of termination.

ARTICLE X
IMMUNOGEN PRODUCTS

10.1      Additional Definitions. Whenever used in this Article X with an
initial capital letter, the terms defined in this Section 10.1 have the meanings
specified:

10.1.1      “Commercialization” means, with respect to the ImmunoGen Product,
any and all activities relating to commercialization, including pre-launch and
launch activities, pricing and reimbursement activities, marketing, medical
affairs support, making or having made for commercial sale, promoting,
detailing, distributing, offering for sale and selling the ImmunoGen Product,
importing or exporting the ImmunoGen Product for sale, conducting post-marketing
human clinical trials, reporting of adverse events in patients, and interacting
with Regulatory

-64-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Authorities regarding any of the foregoing. When used as a verb, “Commercialize”
means to engage in Commercialization and “Commercialized” has a corresponding
meaning.

10.1.2      “Development” means, with respect to the ImmunoGen Product, any and
all activities relating to discovery, research and development in connection
with seeking, obtaining or maintaining any Regulatory Approval for the ImmunoGen
Product, including all pre-clinical research and development activities, all
pre-marketing human clinical studies (including clinical trial design and
operations), test method development and stability testing, regulatory
toxicology studies, formulation, all activities relating to developing the
ability to manufacture the ImmunoGen Product or any component or intermediate
thereof (including process development, manufacturing scale-up,
development-stage manufacturing and quality assurance/quality control
development), statistical analysis and report writing, preparing and filing Drug
Approval Applications, reporting of adverse events in clinical study subjects,
and all regulatory affairs related to the foregoing. When used as a verb,
“Develop” or “Developing” means to engage in Development and “Developed” has a
corresponding meaning.

10.1.3      “Drug Approval Application” means, with respect to the ImmunoGen
Product in a particular country or region, an application for Regulatory
Approval to market and sell the ImmunoGen Product in such country or region,
including: (a) an NDA or sNDA; (b) a BLA or BLA supplement; (c) a counterpart of
an NDA, sNDA, BLA or BLA supplement, including any MAA, in any country or region
outside the U.S.; and (d) all supplements and amendments to any of the
foregoing.

10.1.4      “First Commercial Sale” means, with respect to any ImmunoGen Product
in any country, the first sale of the ImmunoGen Product by or under the
authority of ImmunoGen, an Affiliate of ImmunoGen, or their ImmunoGen Licensees
to a Third Party in that country following Regulatory Approval of such ImmunoGen
Product in that country or, if no such Regulatory Approval or similar approval
is required, the date on which such ImmunoGen Product is first commercially
launched in such country; provided that “First Commercial Sale” shall not
include: [***].

-65-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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10.1.5      “Generic Competition” means, with respect to the ImmunoGen Product
in any country in the Territory, that one or more Generic Products are or become
commercially available in such country, and such Generic Products have a market
share (in the aggregate) of [***] or greater in a Calendar Quarter, provided
that such Generic Competition shall be deemed to exist only for so long as unit
volume sales of such Generic Products in such country, as a percentage of total
unit volume sales of ImmunoGen Products and such Generic Products, during any
Calendar Quarter thereafter exceeds [***], and, if such Generic Product market
share falls below [***] in such country, Generic Competition shall not
thereafter be deemed to exist until the unit volume market share of Generic
Products again exceeds [***]. Market share is based on the aggregate market in
such country of the ImmunoGen Product and the Generic Products, based on units
of the ImmunoGen Product sold and units of such Generic Products sold in the
aggregate, as reported by Quintiles/IMS Health, or if such data are not
available, such other reliable data source as reasonably agreed by the Parties.

10.1.6      “Generic Product” means, on a country-by-country basis, any
pharmaceutical or biological product (a) that contains (i) an identical active
ingredient as the ImmunoGen Product, or (ii) a [***] as the ImmunoGen Product,
as [***] is used in [***], and subject to the factors set forth in [***], (b)
for which Regulatory Approval is obtained by [***], (c) is approved for use in
such country pursuant to a Regulatory Approval process governing approval of
[***], or an equivalent process for Regulatory Approval [***], or any other
equivalent provision that comes into force, or is the subject of a notice with
respect to the ImmunoGen Product under [***] or any other equivalent provision
that comes into force [***], and (d) is sold in the same country (or is
commercially available in the same country via import from another country) as
the ImmunoGen Product by any Third Party that is [***].

10.1.7      “ImmunoGen Licensee” means any Third Party to which ImmunoGen or its
Affiliates grants a license of the rights to Develop, make or Commercialize
ImmunoGen Products.

10.1.8      “ImmunoGen Standard Exchange Rate Methodology” means, with respect
to amounts invoiced in U.S. Dollars, all such amounts shall be expressed in U.S.
Dollars. With respect to amounts invoiced in a currency other than U.S. Dollars,
all such amounts shall be

-66-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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expressed both in the currency in which the amount was invoiced and in the U.S.
Dollar equivalent. The U.S. Dollar equivalent shall be calculated using
ImmunoGen’s then-current standard exchange rate methodology which is in
accordance with the ImmunoGen Accounting Standards applied in its external
reporting for the conversion of foreign currency sales into U.S. Dollars or, in
the case of ImmunoGen Licensees, such similar methodology, consistently applied.

10.1.9      “Net Sales” means, as to each Calendar Quarter during the applicable
term, the gross invoiced sales prices charged for all ImmunoGen Products sold by
ImmunoGen or its Affiliates or ImmunoGen Licensees to Third Parties throughout
the Territory during such Calendar Quarter in bona fide arm’s length
transactions, as determined in accordance with the ImmunoGen Accounting
Standards, less the following amounts incurred or paid by ImmunoGen or its
Affiliates or ImmunoGen Licensees during such Calendar Quarter with respect to
sales of ImmunoGen Products regardless of the Calendar Quarter in which such
sales were made:

(a)        trade, quantity and cash discounts actually allowed or taken;

(b)       discounts, coupons, refunds, rebates, chargebacks, co-pay provided by
or on behalf of the selling party, retroactive price adjustments, and any other
allowances actually allowed or given which effectively reduce the net selling
price;

(c)        credits or allowances actually given or made for rejection or return
of previously-sold ImmunoGen Products;

(d)       any charges for freight, postage, shipping, warehousing, distribution
or transportation, or for insurance, in each case to the extent borne by
ImmunoGen, or its Affiliates or ImmunoGen Licensees;

(e)        the standard inventory cost of devices used for dispensing or
administering the ImmunoGen Product that are shipped with the ImmunoGen Product
and included in the gross invoiced sales price;

(f)        any tax, tariff, duty or government charge (including any sales,
value added, excise or similar tax or government charge, but excluding any
income tax) levied on

-67-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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the sale, transportation or delivery of the ImmunoGen Product and borne by
ImmunoGen, or its Affiliates or ImmunoGen Licensees without reimbursement from
any Third Party;

(g)        wholesaler inventory management fees and allowances actually paid or
given; and

(h)       other reductions or specifically identifiable amounts deducted for
reasons similar to those listed above in accordance with the ImmunoGen
Accounting Standards.

Net Sales shall not include sales or transfers among ImmunoGen and its
Affiliates and ImmunoGen Licensees where the ImmunoGen Product is intended for
subsequent sale to the end user. All the foregoing elements of Net Sales
calculations shall be determined from the books and records of ImmunoGen and its
Affiliates and ImmunoGen Licensees, maintained in accordance with the ImmunoGen
Accounting Standards or, in the case of ImmunoGen Licensees, such similar
accounting principles, consistently applied.

In the event an ImmunoGen Product is sold as a component of a combination or
bundled product that consists of an ImmunoGen Product together with one or more
other therapeutically active products (a “Combination”), the Net Sales from the
Combination, for the purposes of determining royalty payments hereunder, shall
be determined by multiplying the Net Sales of the Combination (as defined in the
standard Net Sales definition above) by the fraction A/(A+B), where A is the
weighted average per unit sale price of the ImmunoGen Product when sold
separately in finished form in the country in which the Combination is sold in
similar volumes and of the same class, purity, potency and dosage form, and B is
the weighted average per unit sale price of the other product(s) included in the
Combination when sold separately in finished form in the country in which the
Combination is sold in similar volumes and of the same class, purity, potency
and dosage form.

In the event that the weighted average per unit sale price of the ImmunoGen
Product can be determined but the weighted average per unit sale price of the
other product(s) included in the Combination cannot be determined, Net Sales for
purposes of determining royalty payments shall be calculated by multiplying the
Net Sales of the Combination (as defined in the standard Net Sales definition
above) by the fraction A/C, where A is the weighted average sale price of the

-68-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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ImmunoGen Product when sold separately in finished form in the country in which
the Combination is sold in similar volumes and of the same class, purity,
potency and dosage form, and C is the weighted average per unit sale price of
the Combination.

In the event that the weighted average per unit sale price of the other
product(s) included in the Combination can be determined but the weighted
average per unit sale price of the ImmunoGen Product in similar volumes and of
the same class purity, potency and dosage form as in the Combination cannot be
determined, Net Sales for purposes of determining royalty payments shall be
calculated by multiplying Net Sales of the Combination (as defined in the
standard Net Sales definition above) by a fraction determined by the following
formula: one (1) minus (B/C) where B is the weighted average per unit sale price
of the other product(s) included in the Combination when sold separately in
finished form in the country in which the Combination is sold in similar volumes
and of the same class, purity, potency and dosage form and C is the weighted
average per unit sale price of the Combination.

In the event that such average per unit sale price cannot be determined for the
ImmunoGen Product, on the one hand, and all other product(s) included in the
Combination, on the other, Net Sales for the purposes of determining royalty
payments shall be [***].

The weighted average per unit sale price for both the ImmunoGen Product, on the
one hand, and all other product(s) included in the Combination, on the other,
shall be calculated [***] for country [***] and such price shall be used during
[***]. When determining the weighted average per unit sale price in a particular
country of an ImmunoGen Product, other product(s), or Combination, such weighted
average per unit sale price shall be calculated by dividing sales dollars
(translated into U.S. Dollars using the ImmunoGen Standard Exchange Rate
Methodology) by the units sold in such country during the [***] months (or the
number of months in which sales occurred [***]) of the [***] for the respective
ImmunoGen Product, other product(s), or Combination. In the [***], a [***] will
be used for the ImmunoGen Product, other product(s), or Combination. Any over-
or under-payment due to a difference between [***].

10.2      Responsibility and Authority. Upon becoming an ImmunoGen Product,
ImmunoGen shall have sole authority and responsibility for the Development,
manufacture, use

-69-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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and Commercialization of such ImmunoGen Product including: (i) the conduct of
all research and pre-clinical Development activities (including, all
pre-clinical and IND-enabling studies (including toxicology testing), any
pharmaceutical development work on formulations and process development relating
to the ImmunoGen Product); (ii) all activities related to human clinical trials;
(iii) all activities relating to the manufacture and supply of the ImmunoGen
Product (including all required process development and scale up work with
respect thereto); and (iv) all Commercialization activities relating to the
ImmunoGen Product (including marketing, promotion, sales, distribution, import
and export activities and any post-marketing trials and safety surveillance).
Without limiting the generality of the foregoing, as between the Parties,
ImmunoGen shall have full control and authority and sole responsibility for (A)
making all Regulatory Filings for the ImmunoGen Product and filing all Drug
Approval Applications and otherwise seeking all Regulatory Approvals regarding
such matters and (B) the reporting of all adverse events for the ImmunoGen
Product to Regulatory Authorities if and to the extent required by Applicable
Laws.

10.3      Payment of Royalties; ImmunoGen Royalty Term. Commencing on the first
date of First Commercial Sale of each ImmunoGen Product in any country or
jurisdiction, ImmunoGen shall pay to Jazz the following royalties, as calculated
on a product-by-product basis by multiplying the applicable royalty rates below
by the corresponding amount of Net Sales of such ImmunoGen Product sold by
ImmunoGen, its Affiliates and its ImmunoGen Licensees during the applicable
royalty terms described below (each, an “ImmunoGen Royalty Term”):

10.3.1      If Jazz exercises a Jazz Opt-Out pursuant to Section 6.2.4 with
respect to a Collaboration Product [***] for such Collaboration Product,
ImmunoGen shall owe [***] on Net Sales of the resulting ImmunoGen Product;

10.3.2      If Jazz exercises a Jazz Opt-Out pursuant to Section 6.2.4 with
respect to a Collaboration Product [***] for such Collaboration Product but
[***] for such Collaboration Product, then with respect to the resulting
ImmunoGen Product, ImmunoGen shall pay to Jazz a royalty equal to [***] of Net
Sales on a country-by-country basis for a term of [***] years from the date of
First Commercial Sale of such ImmunoGen Product in such country;

-70-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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10.3.3      If Jazz exercises a Jazz Opt-Out pursuant to Section 6.2.4 with
respect to a Collaboration Product [***] for such Collaboration Product but
[***] for such Collaboration Product, then with respect to the resulting
ImmunoGen Product, ImmunoGen shall pay to Jazz a royalty equal to [***] of Net
Sales on a country-by-country basis for a term of [***] years from the date of
First Commercial Sale of such ImmunoGen Product in such country;

10.3.4      If ImmunoGen [***] in [***] pursuant to [***], then ImmunoGen shall
pay to Jazz a royalty equal to [***] of Net Sales on a country-by-country basis,
for a term of [***] years from the date of First Commercial Sale of IMGN632;
provided,  however, that if Jazz [***], then in the event that ImmunoGen or its
Affiliate [***], the Net Sales arising therefrom shall be included in the [***];

10.3.5      If, with respect to a Collaboration Product, all Jazz Options have
become exercisable, but have expired, in each case without exercise, then with
respect to the resulting ImmunoGen Product, ImmunoGen shall pay to Jazz a
royalty equal to [***] of Net Sales on a country-by-country basis for a term of
[***] years from the date of First Commercial Sale of such ImmunoGen Product in
such country;

10.3.6      If ImmunoGen terminates this Agreement pursuant to Section 9.2.2
(Termination for Insolvency) or pursuant to Section 9.2.1 (Termination for
Breach), then (i) with respect to the resulting ImmunoGen Product(s) ImmunoGen
shall pay to Jazz a royalty equal to [***] of Net Sales on a country-by-country
basis for a term of [***] years from the date of First Commercial Sale of such
ImmunoGen Product in such country, and (ii) ImmunoGen shall be entitled to
[***]; and

10.3.7      If Jazz terminates this Agreement pursuant to Section 9.2.2
(Termination for Insolvency) or pursuant to Section 9.2.1 (Termination for
Breach), then with respect to the resulting ImmunoGen Product(s) ImmunoGen shall
pay to Jazz a royalty equal to [***] of Net Sales on a country-by-country basis,
for a term of [***] from the date of First Commercial Sale of such ImmunoGen
Product in such country.

10.4      Payment of Royalties. ImmunoGen shall make any royalty payments owed
to Jazz in U.S. Dollars, quarterly within [***] days following the end of each
Calendar Quarter for which

-71-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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such royalties are deemed to occur (as provided in the next sentence), using the
wire transfer provisions of Section 10.8. Determination of when a sale of any
ImmunoGen Product occurs for purposes of this Agreement shall be made when the
revenue from such sale is recognized by ImmunoGen in accordance with ImmunoGen
Accounting Standards or, in the case of ImmunoGen Licensees, in accordance with
such ImmunoGen Licensees’ respective revenue recognition accounting standards,
consistently applied. Each royalty payment shall be accompanied by a report for
each country in which sales of the ImmunoGen Product occurred in the Calendar
Quarter covered by such statement, specifying each of: (i) the gross sales (if
available) and the Net Sales in each country’s currency of the ImmunoGen Product
during the reporting period by ImmunoGen and its Affiliates and ImmunoGen
Licensees (specifying in reasonable detail each of the deductions to gross sales
used to calculate Net Sales); (ii) the applicable exchange rate to convert each
country’s currency to U.S. Dollars under Section 10.6; (iii) the applicable
royalty rate(s) under Section 10.3 (specifying in reasonable detail each
adjustment, if any, to the royalty rate(s) as provided in Section 10.5); and
(iv) the royalties payable, in U.S. Dollars, which shall have accrued hereunder
with respect to such Net Sales. ImmunoGen shall provide Jazz with a non-binding
estimate of its royalty payments owed to Jazz for each Calendar Quarter at least
[***] days before the end of such Calendar Quarter.

10.5      Generic Competition. If Generic Competition exists with respect to an
ImmunoGen Product in a country in the Territory in a Calendar Quarter during the
applicable ImmunoGen Royalty Term, then the royalties payable with respect to
Net Sales of such ImmunoGen Product sold by ImmunoGen, its Affiliates, and its
ImmunoGen Licensees in such country for such Calendar Quarter shall be reduced
by [***] of the royalties otherwise owed to Jazz pursuant to Section 10.3.

10.6      Accounting.  All payments hereunder shall be made in U.S. Dollars.
Royalties shall be calculated based on Net Sales in U.S. Dollars, with the
conversion of Net Sales in each country to U.S. Dollars according the ImmunoGen
Standard Exchange Rate Methodology.

10.7      No Set-Off; Tax Withholding. All payments made by ImmunoGen to Jazz
hereunder shall be made without set-off or counterclaim and free and clear of
any taxes, duties, levies, fees or charges, except for withholding taxes, if
any. ImmunoGen shall make any applicable

-72-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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withholding payments due on behalf of Jazz and shall provide Jazz with
reasonable proof of payment of such withholding taxes, together with an
accounting of the calculations of such taxes, within [***] days after such
payment is remitted to the proper authority. Any withheld tax remitted by
ImmunoGen to the proper authority shall be treated as having been paid by
ImmunoGen to Jazz for all purposes of this Agreement. The Parties shall
cooperate reasonably in completing and filing documents required under the
provisions of any Applicable Laws in connection with the making of any required
withholding tax payment, or in connection with any claim to a refund of or
credit for any such payment.

10.8      Wire Transfers. All payments by either Party hereunder shall be made
in U.S. Dollars by bank wire transfer in immediately available funds to the
account designated the receiving Party by written notice to paying Party from
time to time.

10.9      Overdue Payments.  Subject to the other terms of this Agreement, any
payments hereunder not paid within the applicable time period set forth herein
shall bear interest from the due date until paid in full, at a rate per annum
equal to the lesser of (a) [***], or (b) the maximum interest rate permitted by
Applicable Law in regard to such payments, calculated in each case from the date
such payment was due through to the date on which payment is actually made;
provided,  however, that with respect to any disputed payments, no interest
payment is due until such dispute is resolved and the interest payable thereon
will be based on the finally resolved amount of such payment, calculated from
the original date on which the disputed payment was due through the date on
which payment is actually made. Such interest and the payment and acceptance
thereof shall not negate or waive the right of a Party to any other remedy,
legal or equitable, to which it may be entitled because of the delinquency of
the payment.

10.10      Records Retention; Audit.

10.10.1            ImmunoGen and its Affiliates and ImmunoGen Licensees shall
keep for at least [***] years from the end of the Calendar Year to which they
pertain complete and accurate records of the Net Sales of the ImmunoGen Product
incurred by ImmunoGen or its Affiliates or ImmunoGen Licensee in sufficient
detail to allow the accuracy of the royalty reports and royalties paid to Jazz
to be confirmed.

-73-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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10.10.2            Subject to the other terms of this Section 10.10.2, at the
request of Jazz, upon at least [***] Business Days’ prior written notice, but no
more often than [***] and not more frequently than [***] with respect to records
covering any specific period of time, and at Jazz’s sole expense (except as
otherwise provided herein), ImmunoGen shall permit an internationally recognized
independent accounting firm [***] to inspect (during regular business hours) at
such place or places where such records are customarily kept the relevant
records required to be maintained by ImmunoGen, its Affiliates and ImmunoGen
Licensees under Section 10.10.1. At Jazz’s request, the independent accounting
firm may audit the then-preceding [***] of ImmunoGen’s records solely for
purposes of verifying the items set forth in Section 10.10.1. Before beginning
the audit the independent accounting firm shall enter into a confidentiality
agreement with both Parties substantially similar to the provisions of Article
VII limiting the disclosure and use of such information by such independent
accounting firm to authorized representatives of the Parties and the purposes
germane to this Section 10.10.2. The independent accounting firm shall provide
its audit report and basis for any determination to ImmunoGen at the time such
report is provided to Jazz. Each Party shall each have the right to request a
further determination by such independent accounting firm as to matters which
such Party disputes within [***] days following receipt of such report. The
Party initiating a dispute will provide the other Party and the independent
accounting firm with a reasonably detailed statement of the grounds upon which
it disputes any findings in the audit report and the independent accounting firm
shall undertake to complete such further determination within [***] days after
the dispute notice is provided, which determination shall be limited to the
disputed matters and provided to both Parties. The Parties shall use reasonable
efforts, through the participation of finance representative of both Parties, to
resolve any dispute arising in relation to the audit by good faith discussion.
The results of any such audit, reflecting the independent accounting firm’s
determination of any disputed matters, shall be binding on both Parties, absent
manifest error. Jazz agrees to treat the results of any such independent
accounting firm’s review of ImmunoGen’s records under this Section 10.10.2 as
Confidential Information of ImmunoGen subject to the terms of Article VII
hereof. If any such audit reveals a deficiency in the calculation of royalties
or other error resulting in any underpayment by ImmunoGen, ImmunoGen shall pay
to Jazz the amount remaining to be paid (plus interest thereon at a rate
provided in Section 10.9) on or before the date the next quarterly royalty
payment would otherwise be due (or, if Jazz notifies ImmunoGen of such
deficiency after

-74-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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the expiration of the applicable ImmunoGen Royalty Term or any such payment
obligation, within [***] days from the date of ImmunoGen’s receipt of written
notification of such deficiency), and if such underpayment is by [***] or more
of the total amounts due over the audited period, ImmunoGen shall pay Jazz’s
reasonable costs and expenses of conducting the audit. If any audit reveals an
inaccuracy in the calculation of royalties resulting in an overpayment by
ImmunoGen, ImmunoGen may invoice Jazz for such overpayment, and Jazz shall pay
such invoice within [***] days from the date of Jazz’s receipt of such invoice.

ARTICLE XI
REPRESENTATIONS AND WARRANTIES

11.1      ImmunoGen Representations. ImmunoGen represents and warrants to Jazz
that, as of the Effective Date:

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

11.1.2      the execution and delivery of this Agreement and the performance of
the transactions contemplated hereby have been duly authorized by all
appropriate ImmunoGen corporate action;

11.1.3      this Agreement is a legal and valid obligation binding upon
ImmunoGen and enforceable in accordance with its terms, and the execution,
delivery and performance of this Agreement by the Parties does not conflict with
or result in any default under any agreement, instrument or understanding to
which ImmunoGen is a party or by which it is bound;

11.1.4      it has not granted any right to any Third Party which would conflict
with (a) the rights (including the Jazz Options) granted to Jazz hereunder or
(b) ImmunoGen’s obligation to enter into the License Agreements and to grant the
rights and licenses to Jazz pursuant to the License Agreements; and

11.1.5      it has obtained all Third Party approvals necessary to enter into
this Agreement, including all necessary shareholder approvals, if any.

-75-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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11.2      Additional Representations and Warranties of ImmunoGen. Except as
otherwise disclosed in the applicable provision of Disclosure Letter, ImmunoGen
represents and warrants to Jazz that, as of the Effective Date:

11.2.1      ImmunoGen has received no written notice from a Third Party claiming
that the use of the Licensed Intellectual Property [***] will infringe the
issued patents of any such Third Party [***];

11.2.2      there is no pending or, to ImmunoGen’s Knowledge, threatened,
litigation that alleges that the use of the Licensed Intellectual Property [***]
would infringe or misappropriate any intellectual property rights of any Third
Party;

11.2.3      to its Knowledge, there is no actual, pending, alleged or threatened
infringement[***] by a Third Party of any of the Licensed Patent Rights (as
defined in the License Agreement) [***] or the Licensed Technology (as defined
in the License Agreement) [***];

11.2.4      the issued Licensed Patent Rights (as defined in the License
Agreement) [***] have not been invalidated and are subsisting, and, to its
Knowledge, [***] there are no pending or threatened interference,
re-examination, opposition or cancellation proceedings involving any issued
Licensed Patent Rights[***];

11.2.5      if Jazz exercises a Jazz Option [***], the Patent Rights [***] would
be Licensed Patent Rights [***];

11.2.6      it owns all right, title and interest in each of the Patent Rights
[***];

11.2.7      it has provided to Jazz’s outside counsel for their review only a
true and correct copy of [***], it has not received any notice of any [***], and
to its Knowledge, there [***];

11.2.8      it and its Affiliates have generated, prepared, maintained, and
retained all Regulatory Filings relating to the Collaboration Products in
accordance with Applicable Law in all material respects, and all information
contained in such Regulatory Filings is true, complete and correct;

-76-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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11.2.9      it and its Affiliates have conducted, and their respective
contractors and consultants have conducted, all Development of the Collaboration
Product, including any and all pre-clinical and clinical studies related to the
Collaboration Product, in accordance with Applicable Law;

11.2.10     neither it nor any of its Affiliates is or has been, and neither it
nor any of its Affiliates or contractors has used in any capacity in connection
with the Development of the Collaboration Products, any Person who is or has
been: (i) debarred by the FDA under 21 U.S.C. § 335a, or to its Knowledge,
threatened with debarment by a pending proceeding, action, or investigation;
(ii) excluded from participation in any federal health care program, including
Medicare and Medicaid, the U.S. Department of Defense Military Health System,
and the U.S. Department of Veterans Affairs, pursuant to the Department of
Health and Human Services Office of Inspector General’s exclusion authority
under 42 U.S.C. § 1320a-7(a), as implemented by 42 C.F.R. Part 1001 et seq., or
the subject of an exclusion proceeding; or (iii) otherwise disqualified under 21
C.F.R. Part 58, subpart K or 21 C.F.R. § 312.7 or any other similar federal or
state law, or to its Knowledge, threatened with such disqualification by pending
proceeding, action, or investigation;

11.2.11     it has the right to use, disclose and reference for the purposes
contemplated in this Agreement, and to grant to Jazz pursuant to the License
Agreement, a [***] for the purposes contemplated in the License Agreement (a)
[***] to ImmunoGen pursuant to the [***] that is related to the Antibody
contained in [***] or any ADC containing such Antibody, (b) [***] in connection
with research and development of the Antibody contained in [***] or any ADC
containing such Antibody and (c) all [***] that is related to [***];

11.2.12     [***] any patentable invention, Patent Rights or other intellectual
property rights[***] in the course of or as a result of [***];

11.2.13     no Technology or Patent Rights [***];

11.2.14     to its Knowledge, there are no Technology or Patent Rights other
than Technology or Patent Rights (a) for which [***] or (b) used in the [***];

-77-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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11.2.15     to its Knowledge, there are no Technology or Patent Rights owned or
controlled by a Third Party that [***]; and

11.2.16     (a) it has a [***], (b) it has [***], and (c) following [***] and
may [***], in each case [***].

11.3      Jazz Representations. Jazz represents and warrants to ImmunoGen that,
as of the Effective Date:

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

11.3.2      the execution and delivery of this Agreement and the performance of
the transactions contemplated hereby have been duly authorized by all
appropriate Jazz corporate action; and

11.3.3      this Agreement is a legal and valid obligation binding upon Jazz and
enforceable in accordance with its terms, and the execution, delivery and
performance of this Agreement by the Parties does not conflict with or result in
any default under any agreement, instrument or understanding to which Jazz is a
party or by which it is bound; and

11.3.4      it has obtained all Third Party approvals necessary to enter into
this Agreement, including all necessary stockholder approvals, if any.

11.4      Warranty Disclaimers.

11.4.1      Except as expressly set forth in Section 11.1 or 11.2, nothing in
this Agreement is or shall be construed as a warranty or representation by
ImmunoGen that the manufacture, use, sale, offer for sale or import of any
Collaboration Product is or will be free from infringement of patents,
copyrights, and other rights of Third Parties.

11.4.2      EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER
PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY

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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, WITH RESPECT TO ANY TECHNOLOGY, GOODS,
SERVICES, RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT, AND EACH PARTY
HEREBY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF
TITLE, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT.

11.5      Covenants. During the Term, ImmunoGen shall and shall ensure that its
Affiliates shall:

11.5.1      not use in any capacity, in connection with the performance of the
ImmunoGen Activities, any Person who (a) has been debarred pursuant to Section
306 of the FDCA, (b) to ImmunoGen’s Knowledge, is threatened with debarment by a
pending proceeding, action, or investigation, (c) is the subject of a conviction
described in such section, (d) has been excluded from participation in any
federal health care program, including Medicare and Medicaid, the U.S.
Department of Defense Military Health System, and the U.S. Department of
Veterans Affairs, pursuant to the Department of Health and Human Services Office
of Inspector General’s exclusion authority under 42 U.S.C. § 1320a-7(a), as
implemented by 42 C.F.R. Part 1001 et seq., or the subject of an exclusion
proceeding; or (e) is otherwise disqualified under 21 C.F.R. Part 58, subpart K
or 21 C.F.R. § 312.70 or similar federal or state laws, or to ImmunoGen’s
Knowledge, threatened with such disqualification by pending proceeding, action,
or investigation;. ImmunoGen agrees to inform Jazz in writing promptly if it or
any such Person who is performing or has performed the ImmunoGen Activities is
debarred, excluded or disqualified or is the subject of a conviction described
in Section 306 of the FDCA or if any action, suit, claim, investigation or legal
or administrative proceeding is pending or, to ImmunoGen’s Knowledge, is
threatened, related to the debarment, exclusion, disqualification or conviction
of it or any such Person.

11.5.2      [***], directly or indirectly through any Person, or [***] regarding
[***] any Collaboration Product for which any Jazz Options remain unexpired and
for which Jazz has not exercised a Jazz Opt-Out in any country or jurisdiction
in the Territory, other than [***];

11.5.3      [***] or [***] (a) any Patent Rights or Technology [***] that would
[***], but for such [***] or (b) [***], except (i) to an Affiliate in a manner
that would not adversely

-79-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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affect rights granted by ImmunoGen to Jazz under this Agreement or to be granted
under any License Agreement, (ii) if [***] other than  in a manner that [***],
or (iii) if such [***] is applicable to [***] to [***] in a manner that [***];
 provided that, the [***] shall [***] with respect to any [***] that relate to a
Collaboration Product for which all Jazz Options have expired unexercised or for
which Jazz has exercised a Jazz Opt-Out and do not relate to any other
Collaboration Product;

11.5.4      [***];

11.5.5      [***];

11.5.6      [***], in each case for [***] for the Collaboration Products;

11.5.7      at Jazz’s request, [***], that include (a) [***] and (b) [***]; and

11.5.8      [***] provided that, the foregoing restrictions shall no longer
apply with respect to any Patent Rights or Technology that solely relate to a
Collaboration Product for which all Jazz Options have expired unexercised or for
which Jazz has exercised a Jazz Opt-Out and do not relate to any other
Collaboration Products.

11.6      Anti-Corruption Laws. Without limiting the foregoing, each Party shall
comply with the United States Foreign Corrupt Practices Act (FCPA), the UK
Bribery Act 2010 or any other applicable equivalent laws (collectively
“Anti-Corruption Laws”), and shall not cause the other Party or its Affiliates,
directors, officers, shareholders, employees or agents to be in violation of any
Anti-Corruption Laws. Without limiting the foregoing, neither Party shall,
directly or indirectly, pay any money to, or offer or give anything of value to,
any “foreign official” as that term is used in the FCPA or any “foreign public
official” as that term is used in the FCPA, in order to obtain or retain
business or to secure any commercial or financial advantage for the other Party
or for itself or any of their respective Affiliates or sublicensees.

ARTICLE XII
INDEMNIFICATION; LIABILITY

12.1      Indemnification.

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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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12.1.1      Jazz Indemnity. Jazz shall indemnify, defend and hold harmless
ImmunoGen, its Affiliates, their respective directors, officers, employees,
consultants and agents, and their respective successors, heirs and assigns (the
“ImmunoGen Indemnitees”), from and against all liabilities, damages, losses and
expenses (including reasonable attorneys’ fees and expenses of litigation)
(collectively, “Losses”) incurred by or imposed upon the ImmunoGen Indemnitees,
or any of them, as a direct result of any Third Party claims, suits, actions,
demands or judgments, including personal injury and product liability matters
(collectively, “Third Party Claims”), arising out of (a) a breach of this
Agreement by Jazz, or (b) the negligence, recklessness or willful misconduct of
Jazz or any of its Affiliates or subcontractors, except in each case to the
extent any such Third Party Claim or Losses result from (i) a breach of this
Agreement by ImmunoGen, or (ii) the negligence, recklessness or willful
misconduct of ImmunoGen or any of its Affiliates, (iii) the conduct of the Early
Research Programs or ImmunoGen Activities by or on behalf of ImmunoGen or any of
its Affiliates, (iv) [***] or (v) the Development or Commercialization
(including the production, manufacture, promotion, import, sale or use by any
Person) of any ImmunoGen Product by or on behalf of ImmunoGen or any of its
Affiliates, licensees, contractors, distributors or agents; provided that with
respect to any such Third Party Claim for which ImmunoGen also has an obligation
to any Jazz Indemnitee pursuant to Section 12.1.2, Jazz shall indemnify each
ImmunoGen Indemnitee for its Losses to the extent of Jazz’s responsibility,
relative to ImmunoGen (or to Persons for whom ImmunoGen is legally responsible),
for the facts underlying the Third Party Claim.

12.1.2      ImmunoGen Indemnity. ImmunoGen shall indemnify, defend and hold
harmless Jazz, its Affiliates, their respective directors, officers, employees,
consultants and agents, and their respective successors, heirs and assigns (the
“Jazz Indemnitees”), from and against all Losses incurred by or imposed upon the
Jazz Indemnitees, or any of them, as a direct result of any Third Party Claims
arising out of (a) a breach of this Agreement by ImmunoGen, (b) the conduct of
the Early Research Programs or ImmunoGen Activities by or on behalf of ImmunoGen
or any of its Affiliates, (c) the Development or Commercialization (including
the production, manufacture, promotion, import, sale or use by any Person) of
any ImmunoGen Product by or on behalf of ImmunoGen or any of its Affiliates,
licensees, contractors, distributors or agents, (d) [***] or (e) the negligence,
recklessness or willful misconduct of ImmunoGen or any of its

-81-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Affiliates or subcontractors, except in each case to the extent any such Third
Party Claim or Losses result from (i) a breach of this Agreement by Jazz, or
(ii) the negligence, recklessness or willful misconduct of, Jazz or any of its
Affiliates or subcontractors; provided that with respect to any such Third Party
Claim for which Jazz also has an obligation to any ImmunoGen Indemnitee pursuant
to Section 12.1.1, ImmunoGen shall indemnify each Jazz Indemnitee for its Losses
to the extent of ImmunoGen’s responsibility, relative to Jazz (or to Persons for
whom Jazz is legally responsible), for the facts underlying the Third Party
Claim.

12.2      Procedure. A Person seeking indemnification under Section 12.1 (the
“Indemnified Party”) in respect of a Third Party Claim shall give prompt notice
of such Third Party Claim to the Party from which recovery is sought (the
“Indemnifying Party”) and shall permit the Indemnifying Party to assume
direction and control of the defense of the Third Party Claim, provided that the
Indemnifying Party shall act reasonably and in good faith with respect to all
matters relating to the defense or settlement of such Third Party Claim as the
defense or settlement relates to the Indemnified Party. The Indemnified Party,
its employees and agents, shall reasonably cooperate with the Indemnifying Party
and its legal representatives in the investigation and defense of such Third
Party Claim. The foregoing notwithstanding, the Indemnified Party shall have the
right to participate in, but not control, the defense of any Third Party Claim,
and request separate counsel, with such attorneys’ fees and expenses or
litigation to be paid by the Indemnified Party, unless (a) representation of
such Indemnified Party by the counsel retained by the Indemnifying Party would
be inappropriate due to actual or potential conflicting interests between such
Indemnified Party and any other Person represented by such counsel in such
proceedings, or (b) the Indemnifying Party has failed to assume the defense of
the applicable Third Party Claim, and in connection with either clause (a) or
(b) above, such reasonable attorneys’ fees and expenses of litigation shall be
paid by the Indemnifying Party. Neither the Indemnifying Party nor the
Indemnified Party shall settle or otherwise resolve such Third Party Claim
without the other’s prior written consent (which consent shall not be
unreasonably withheld, conditioned or delayed); provided that the Indemnifying
Party may, without the Indemnified Party’s prior written consent, agree or
consent to any settlement or other resolution of such Third Party Claim which
requires solely money damages paid by the Indemnifying Party, and which includes
as an unconditional

-82-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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term thereof the giving by such claimant or plaintiff to the Indemnified Party
of a release from all liability in respect of such Third Party Claim.

12.3      Insurance. During the Term and for a period of at least [***] years
thereafter (or for ImmunoGen, in the event ImmunoGen is Developing or
Commercializing (as defined in Section 10.1) ImmunoGen Products, for a period of
at least [***] years after ImmunoGen ceases all such Development and
Commercialization of such ImmunoGen Products), each Party shall maintain on an
ongoing basis without interruption comprehensive general liability insurance in
the minimum amount of (a) [***] per occurrence and [***] annual aggregate
combined single limit for [***] liability at all times during which the
applicable product is [***] and for [***] thereafter (unless subsection (b)
applies) and (b) [***] per occurrence and [***] annual aggregate combined single
limit for [***] liability at all times during which the applicable product is
[***] by such Party and for [***] years thereafter, and any other insurance
required by Applicable Laws. All of such insurance coverage may be maintained
through a self-insurance plan that substantially complies with the foregoing
limits and requirements. Each Party shall use commercially reasonable efforts to
provide the other Party at least [***] days’ prior written notice of any
cancellation to or material change in its insurance coverage below the amounts
and types described above. Each such insurance policy shall contain a waiver of
subrogation by the insurer, or self-insurer as applicable, against Jazz or
ImmunoGen, as the case may be.

12.4      Limited Liability.  [***], NEITHER PARTY WILL BE LIABLE WITH RESPECT
TO ANY SUBJECT MATTER OF THIS AGREEMENT UNDER ANY CONTRACT, NEGLIGENCE, STRICT
LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR ANY SPECIAL, INCIDENTAL,
INDIRECT, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES (INCLUDING ANY DAMAGES
RESULTING FROM LOSS OF PROFITS, LOSS OF BUSINESS OR LOSS OF GOODWILL TO THE
EXTENT THAT SUCH DAMAGES ARE NOT DIRECT DAMAGES), EVEN IF EITHER PARTY IS
INFORMED IN ADVANCE OF THE POSSIBILITY OF SUCH DAMAGES. For purposes of clarity,
a Party’s monetary liability under a Third Party Claim for such Third Party’s
special, incidental, indirect or consequential damages, or for any exemplary or
punitive damages payable

-83-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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to such Third Party in connection with such Third Party Claim, shall be deemed
to be the direct damages of such Party for purposes of this Article XII.

ARTICLE XIII
MISCELLANEOUS

13.1      Notices. All notices and communications shall be in writing and
delivered personally or by courier or mailed via certified mail, return receipt
requested, postage prepaid, internationally recognized courier, addressed as
follows:

If to ImmunoGen:       ImmunoGen, Inc.

830 Winter Street

Waltham, MA 02451

United States of America

Attn: Vice President, Business Development

with a copy to:            ImmunoGen, Inc.

830 Winter Street

Waltham, MA 02451

United States of America

Attn: Legal Department

If to Jazz:                    Jazz Pharmaceuticals Ireland Limited

Waterloo Exchange

Waterloo Road

Dublin 4

Ireland

Attn: Secretary

with a copy to:            Jazz Pharmaceuticals

3180 Porter Drive

Palo Alto, California 94304

United States of America

Attn: General Counsel

with a copy to:            Cooley LLP

3175 Hanover Street

Palo Alto, CA 94304-1130

United States of America

Attn: Marya A. Postner, Ph.D.

Except as otherwise expressly provided in this Agreement or mutually agreed in
writing, any notice, communication or document (excluding payment) required to
be given or made shall

-84-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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be deemed given or made and effective upon actual receipt or, if earlier, (a)
one (1) Business Day after deposit with a nationally recognized overnight
express courier with charges prepaid, or (b) [***] Days after mailed by
certified mail, return receipt requested, postage prepaid, in each case
addressed to the receiving Party at its address stated above or to such other
address as such Party may designate by written notice given in accordance with
this Section 13.1.

13.2      Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of New York without regard to any choice
of law principle that would dictate the application of the law of another
jurisdiction.

13.3      Entire Agreement. This Agreement constitutes the entire agreement
between the Parties with respect to the subject matter hereof and supersedes any
prior or contemporaneous agreements, understandings, negotiations or
correspondence between the Parties, written or oral (including the
Confidentiality Agreement) concerning the subject matter hereof.

13.4      Amendment and Waiver. This Agreement may be amended, modified or
changed only by a written instrument executed by the Party to be bound. No term
of this Agreement will be deemed to have been waived and no breach excused,
unless such waiver or consent shall be in writing and signed by the Party
claiming to have waived or consented. Any consent by any Party to, or waiver of,
a breach by the other, whether express or implied, shall not constitute consent
to, or waiver of, or excuse for, any other different or subsequent breach.

13.5      Binding Effect. This Agreement shall be binding upon and inure to the
benefit of the Parties and their respective successors and permitted assigns.
Except as set forth in Article XII, no Third Party (including employees of
either Party) shall have or acquire any rights by reason of this Agreement.

13.6      Purpose and Scope. Nothing in this Agreement shall be construed to
establish any agency, employment, partnership, joint venture, franchise or
similar or special relationship between the Parties. Neither Party shall have
the right or authority to assume or create any obligations or to make any
representations, warranties or commitments on behalf of the other Party, whether
express or implied, or to bind the other Party in any respect whatsoever. Except
as

-85-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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expressly set forth elsewhere in this Agreement, neither Party grants to the
other Party any right or license to any of its intellectual property.

13.7      Headings. Section and subsection headings are inserted for convenience
of reference only and do not form part of this Agreement.

13.8      Assignment. Neither Party may assign this Agreement without the prior
written consent of the other Party, which consent shall not be unreasonably
withheld, conditioned or delayed, except that such consent shall not be required
in connection with any assignment to an Affiliate of the assigning Party, or to
a Third Party in connection with a sale or transfer of the business to which
this Agreement relates, or to any successor Person resulting from any merger or
consolidation of such Party with or into such Person, provided that the assignee
shall have agreed in writing to assume all of the assignor’s obligations
hereunder, and provided,  further, that the other Party shall be notified
promptly after such assignment has been effected. Any such assignment shall not
relieve the assigning Party of any liabilities or obligations owed to the other
Party hereunder, including in the case of Jazz, the payment of any amounts
described in Article VI, and in the case of ImmunoGen, the payment of any
amounts described in Article X. Any purported assignment of this Agreement in
violation of this Section 13.8 shall be null and void.

13.9      Performance by Affiliates. Each Party may discharge any obligations
and exercise any right hereunder through any of its Affiliates. Each Party
hereby guarantees the performance by its Affiliates of such Party’s obligations
under this Agreement, and shall cause its Affiliates to comply with the
provisions of this Agreement in connection with such performance. Any breach by
a Party’s Affiliate of any of such Party’s obligations under this Agreement
shall be deemed a breach by such Party, and the other Party may proceed directly
against such Party without any obligation to first proceed against such Party’s
Affiliate.

13.10      Force Majeure. Neither Party shall be liable for failure of or delay
in performing obligations set forth in this Agreement, and neither shall be
deemed in breach of its obligations, if such failure or delay is due to natural
disasters or any causes beyond the reasonable control of such Party, provided
that financial inability in and of itself shall not be considered to be a force
majeure

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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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event. In event of such force majeure, the Party affected thereby shall use
commercially reasonable efforts to cure or overcome the same and resume
performance of its obligations hereunder.

13.11      Interpretation. The Parties hereto acknowledge and agree that: (a)
each Party and its counsel reviewed and negotiated the terms and provisions of
this Agreement and have contributed to its revision; (b) the rule of
construction to the effect that any ambiguities are resolved against the
drafting Party shall not be employed in the interpretation of this Agreement;
and (c) the terms and provisions of this Agreement shall be construed fairly as
to each Party hereto and not in a favor of or against any Party, regardless of
which Party was generally responsible for the preparation of this Agreement. In
addition, unless the context otherwise requires, wherever used in this
Agreement: (i) the singular shall include the plural, the plural the singular;
(ii) the use of any gender shall be applicable to all genders; (iii) the words
“include” or “including” shall be construed as incorporating, also, “but not
limited to” or “without limitation” (irrespective of whether such words are used
in the applicable instance); (iv) the words “hereof,” “herein,” “hereby” and
derivative or similar words refer to this Agreement as a whole and not to any
particular provision of this Agreement; and (v) all references to “will” are
interchangeable with the word “shall” and shall be understood to be imperative
or mandatory in nature.

13.12      Severability. If any provision of this Agreement shall be held by a
court of competent jurisdiction, or declared under any law, rule or regulation
of any government having jurisdiction over the Parties hereto, to be illegal,
invalid or unenforceable, then such provision will, to the extent permitted by
the court or government, not be voided, but will instead be construed to give
effect to the intentions of the Parties to the maximum extent permissible under
Applicable Laws, and the remainder of this Agreement will remain in full force
and effect in accordance with its terms.

13.13      Dispute Resolution.

13.13.1            Senior Officers. The Parties recognize that a bona fide
dispute as to certain matters may from time to time arise during the Term
relating to either Party’s rights or obligations hereunder or otherwise relating
to the validity, enforceability, interpretation, application, or performance of
this Agreement, including disputes relating to alleged breach or termination of
this

-87-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Agreement (hereinafter, a “Dispute”). In the event of the occurrence of any such
Dispute, upon the written request of either Party, the Parties shall refer such
Dispute to their respective senior officers designated below (“Senior
Officers”), for attempted resolution by good faith negotiations commencing
within [***] days after such written notice is received. The Senior Officers of
the Parties are as follows:

For Jazz: A senior officer designated by Jazz at the time of the Dispute who has
settlement authority over the Dispute; and

For ImmunoGen: Chief Executive Officer.

Subject to Section 2.2.4, if the Senior Officers are not able to resolve such
Dispute within [***] days following delivery of the notice referring the Dispute
to the Parties’ respective Senior Officers, then either Party may then invoke
the provisions of Section 13.13.2.

13.13.2            Arbitration.

(a)        CPR Rules. Except as set forth in Section 13.13(b), any Dispute that
is not resolved pursuant to Section 13.13.1 shall be finally resolved by
arbitration in accordance with the International Institute for Conflict
Prevention and Resolution Rules for Administered Arbitration by three
arbitrators (the “CPR Rules Tribunal”), of whom each Party shall designate one,
with the third arbitrator to be designated by the two Party-designated
arbitrators (each such arbitration under this Section 13.13.2(a) or under
Section 13.13.2(b), an “Arbitration”).

(b)       CPR Accelerated Rules. Any Dispute relating to whether ImmunoGen is in
material breach of its obligations with respect to the Development Plan for any
particular Collaboration Product (including the obligations set forth in Section
5.1.4) that is not resolved pursuant to Section 13.13.1, shall be finally
resolved by arbitration in accordance with the International Institute for
Conflict Prevention & Resolution Global Rules for Accelerated Commercial
Arbitration (the “Accelerated Rules”), in effect on the date the arbitration is
commenced, by one arbitrator (the “Accelerated Rules Tribunal” and collectively
with the CPR Rules Tribunal, as applicable, the “Tribunal”) appointed in
accordance with the Accelerated Rules (provided, that any such arbitrator has
confirmed his or her availability to comply with the target

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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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award dates specified herein). The Accelerated Rules Tribunal shall establish a
schedule for the arbitration that will result in issuance of an award in as
short a period as feasible under the circumstances, consistent with the
reasonable needs of the Parties, the subject matter of the arbitration and such
other factors as the Accelerated Rules Tribunal determines to be appropriate,
but not later than six (6) months from the selection of the Accelerated Rules
Tribunal.

(c)        General. The Tribunal shall enforce and not modify the terms of this
Agreement. The place of Arbitration shall be the Borough of Manhattan, City of
New York, New York.

(d)       Award. Any award shall be promptly paid in U.S. Dollars free of any
tax, deduction or offset, and any costs, fees, or taxes incident to enforcing
the award shall, to the maximum extent permitted by law, be charged against the
Party resisting enforcement. Each Party shall abide by the award rendered in any
Arbitration conducted pursuant to this Section 13.13.2, and agrees, that subject
to the Federal Arbitration Act, judgment may be entered upon the final award in
a court of competent jurisdiction and that other courts may award full faith and
credit to such judgment in order to enforce such award. The award will include
interest from the date of any damages incurred for breach of the Agreement, and
from the date of the award until paid in full, at a rate fixed by the Tribunal.

(e)        Costs. Except as set forth in Section 13.13.2(d), each Party shall
bear its own legal fees, costs and expenses. The Tribunal shall assess its
costs, fees and expenses against the Party losing the Arbitration unless
concludes that neither Party is the clear loser, in which case the Tribunal
shall divide its fees, costs and expenses according to its sole discretion.

(f)        Confidentiality. Except to the limited extent necessary to comply
with Applicable Law, legal process, or a court order or to enforce a final
settlement agreement or secure enforcement or vacatur or the Tribunal’s award,
the Parties agree that the existence, terms and content of any Arbitration, all
information and documents disclosed in any Arbitration or evidencing any
Arbitration results, award, judgment or settlement, or the performance thereof,
and any allegations, statements and admissions made or positions taken by either
Party in any

-89-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Arbitration shall be treated and maintained in confidence and are not intended
to be used or disclosed for any other purpose or in any other forum.

13.14      Interim Equitable Relief. Anything contained in this Agreement to the
contrary notwithstanding, if a Party reasonably requires relief on a more
expedited basis than would be possible pursuant to the procedures set forth in
Section 13.13, such Party may seek a temporary injunction or other interim
equitable relief in a court of competent jurisdiction, without posting a bond,
pending the resolution of the Dispute in accordance with Section 13.13. Any such
remedies will be in addition to all other remedies available by law or at equity
to the injured Party.

13.15      Prohibition on Hiring; Solicitation. Without ImmunoGen’s prior
written consent, neither Jazz nor any of its Affiliates shall, [***],  (a)
solicit, directly or indirectly, for hire or engagement any person who is at the
time, or was within [***] months of the time, materially involved in performing
activities pursuant to a Research Plan or a Development Plan under this
Agreement [***], or (b) induce, directly or indirectly, any person who is, at
the time of such inducement, an employee of ImmunoGen who is materially involved
in performing activities pursuant to a Research Plan or a Development Plan under
this Agreement (and such involvement was known to Jazz) to leave such
employment. Notwithstanding the foregoing, clauses (a) and (b) above shall not
restrict Jazz or any of its Affiliates from general solicitations, including
advertising employment opportunities on Jazz’s website, job boards, and social
media (such as LinkedIn), or engaging in other activity directed towards
recruitment of personnel, in each case if and to the extent that such general
solicitation, advertising, or activities do not specifically target employees of
ImmunoGen or its Affiliates. For purposes of clarity under this Section 13.15,
“solicit” excludes circumstances where an employee of ImmunoGen initially
contacts Jazz seeking employment.

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

13.17      Execution. This Agreement may be executed in two or more
counterparts, all of which when taken together shall be considered one and the
same agreement and shall become effective when counterparts have been signed by
each Party and delivered to the other Party, it

-90-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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being understood that both Parties need not sign the same counterpart. If any
signature is delivered by facsimile transmission or by e-mail delivery of a
“PDF” format data file, such signature shall create a valid and binding
obligation of the Party executing (or on whose behalf such signature is
executed) with the same force and effect as if such facsimile or “PDF” signature
page were an original thereof.

[Signature page follows]

 

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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized representatives.

 

 

 

 

 

IMMUNOGEN, INC.

    

JAZZ PHARMACEUTICALS

 

 

 

IRELAND LIMITED

 

 

 

 

 

 

 

 

 

 

By:

/s/ Peter Williams

 

By:

/s/ Paul Treacy

 

 

 

 

 

Name:

Peter Williams

 

Name:

Paul Treacy

 

 

 

 

 

Title:

Vice President, Business Development

 

Title:

Director

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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SCHEDULE A

FINANCIAL TERMS

Jazz Option Exercise Fee

 

 

 

 

 

 

Collaboration Product

Early-Stage Option Payment ($M)

Late-Stage Option Payment ($M)

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

1Jazz shall pay ImmunoGen (a[***] at the time that Jazz exercises the Late Stage
Option for [***] triggered by [***] and (b) an additional [***] within [***]
days after the earlier of (i) ImmunoGen’s notice to Jazz that it is not
exercising the ImmunoGen Opt-In Right and (ii) expiration of the ImmunoGen
Opt-in Right without exercise.

2Jazz shall pay ImmunoGen (a) [***] at the time Jazz exercises the Late Stage
Option for IMGN632 [***], IMGN779 and the New Product and (b) an additional
[***] within [***] days after the earlier of (i) ImmunoGen’s notice to Jazz that
it is not exercising the ImmunoGen Opt-In Right and (ii) expiration of the
ImmunoGen Opt-In Right without exercise.

3  Jazz shall pay ImmunoGen [***] at the time Jazz exercises the Early Stage
Option for the New Product following [***].

 

 

A-1

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

SCHEDULE B

FORM OF LICENSE AGREEMENT

See attached.

 

 

B-1

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

Schedule B

FORM OF LICENSE AGREEMENT

between

IMMUNOGEN, INC.

and

JAZZ PHARMACEUTICALS IRELAND LIMITED

dated

[_____]

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

Table of Contents

 

 

 

 

Page

1.

DEFINITIONS

1

2.

GRANT OF RIGHTS

30

 

2.1.

License Grants

30

 

2.2.

Retained Rights

31

 

2.3.

Covenants

31

 

2.4.

No Implied Licenses

31

3.

Governance

31

 

3.1.

Alliance Management

31

 

3.2.

Joint Steering Committee

32

 

3.3.

Joint Development Committee

34

 

3.4.

Joint Patent Committee

36

 

3.5.

One Committee

37

4.

Development and Commercialization

37

 

4.1.

Development and Commercialization

37

 

4.2.

Safety; Adverse Event Reporting

39

 

4.3.

Updates and Reports; Notification of Milestones; Product Recalls

39

 

4.4.

Use of ImmunoGen Proprietary Materials

41

 

4.5.

Unauthorized Use of ImmunoGen’s Proprietary Materials and Confidential
Information

41

5.

SUPPLY AND MANUFACTURING OBLIGATIONS; SERVICES

44

 

5.1.

Manufacturing Responsibilities

44

 

5.2.

Technology Transfers

44

 

5.3.

Interim Supply; CMO Agreements

45

6.

FINANCIAL TERMS

46

 

6.1.

Upfront Payment

46

 

6.2.

Development Costs

46

 

6.3.

Milestone Payments for Licensed Product

50

 

6.4.

Payment of Royalties; Royalty Rates; Accounting for Royalties and Records

51

 

6.5.

Royalty Term

54

 

6.6.

Payment Terms

55

 

 

-i-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

 

 

 

 

 

6.7.

Overdue Payments

56

 

6.8.

Records Retention; Audit

57

 

6.9.

Financial Statements

58

7.

CO-DEVELOPMENT OPT-IN RIGHT

60

 

7.1.

ImmunoGen Opt-In Right

60

8.

TREATMENT OF CONFIDENTIAL INFORMATION

60

 

8.1.

Confidentiality

60

 

8.2.

Publicity

62

 

8.3.

Publications and Presentations

63

 

8.4.

Integration

64

9.

FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS

65

 

9.1.

Ownership of Intellectual Property; Disclosure

65

 

9.2.

Patent Filing, Prosecution and Maintenance

66

 

9.3.

Abandonment

69

 

9.4.

Third Party Infringement

70

 

9.5.

Response to Biosimilar Applicants

73

 

9.6.

Invalidity or Unenforceability Defenses or Actions

77

 

9.7.

Defense of Claims

78

 

9.8.

Trademarks

78

 

9.9.

Patent Term Extensions

79

.

9.10

Bankruptcy

79

10.

TERM AND TERMINATION

79

 

10.1.

Term

79

 

10.2.

Termination

79

 

10.3.

HSR Waiting Period

81

 

10.4.

Consequences of Termination

81

 

10.5.

Alternative to Termination

81

 

10.6.

Remedies

81

 

10.7.

Surviving Provisions

86

11.

Immunogen product

87

 

11.1.

Development Responsibility and Authority

87

 

11.2.

Grant of Rights

88

 

11.3.

Financial Terms

88

 

-ii-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

 

 

 

 

12.

REPRESENTATIONS AND WARRANTIES

92

 

12.1.

ImmunoGen Representations

92

 

12.2.

Jazz Representations

95

 

12.3.

Warranty Disclaimers

95

 

12.4.

Anti-Corruption Laws

96

13.

INDEMNIFICATION; LIABILITY

96

 

13.1.

Indemnification

96

 

13.2.

Procedure

98

 

13.3.

Insurance

98

 

13.4.

Limited Liability

99

14.

MISCELLANEOUS

100

 

14.1.

Notices

100

 

14.2.

Governing Law

101

 

14.3.

Entire Agreement

101

 

14.4.

Amendment and Waiver

101

 

14.5.

Binding Effect

101

 

14.6.

Purpose and Scope

101

 

14.7.

Headings

102

 

14.8.

Assignment

102

 

14.9.

Performance by Affiliates

102

 

14.10.

Force Majeure

102

 

14.11.

Interpretation

103

 

14.12.

Severability

103

 

14.13.

Dispute Resolution

103

 

14.14.

Interim Equitable Relief

106

 

14.15.

Further Assurances

106

 

14.16.

Antitrust Filings

106

 

14.17.

Execution

108

 

 

-iii-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

LICENSE AGREEMENT

This License Agreement (this “Agreement”) is dated as of _________________1 (the
“Signing Date”) by and between ImmunoGen, Inc., a Massachusetts corporation
(“ImmunoGen”), with its principal place of business at 830 Winter Street,
Waltham, Massachusetts 02451, and Jazz Pharmaceuticals Ireland Limited, a
corporation organized under the laws of Ireland (“Jazz”), with its principal
place of business at Waterloo Exchange, Waterloo Road, Dublin 4, Ireland.
ImmunoGen and Jazz are sometimes each hereinafter referred to individually as a
“Party” and collectively as the “Parties.”

WHEREAS, the Parties have entered into a Collaboration and Option Agreement,
pursuant to which ImmunoGen granted Jazz the right to obtain licenses to develop
and commercialize the Licensed Product as set forth herein;

WHEREAS, pursuant to the Collaboration and Option Agreement, Jazz has exercised
a Jazz Option (as defined in the Collaboration and Option Agreement) pursuant to
which the Parties have agreed to enter into this Agreement setting forth the
terms and conditions of the licenses;

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

1.         DEFINITIONS

Whenever used in this Agreement with an initial capital letter, the terms
defined in this Article 1 have the meanings specified.

1.1.      “ADC” means any compound that incorporates, is comprised of, or is
otherwise derived from, a conjugate of an Antibody with a Cytotoxic Compound,
whether with or without a Linker.

 

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

1 Insert Jazz Option exercise date, as defined in the Collaboration and Option
Agreement, with respect to this License Agreement.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

1.2.      “ADC Platform Improvement” means any enhancement, improvement, or
modification (each, an “Improvement”) to the following Licensed Intellectual
Property: (a) the [***] of [***] or [***] contained in [***], (b) [***] of [***]
or [***] contained in [***], (c) the [***] for [***] contained in [***]
(including [***] or [***] that create improvements in [***] of [***]), (d) the
[***] for [***] or [***] any [***] or [***] contained in [***], or (e) the [***]
of [***] contained in [***], in each case of (a)–(e), [***] such [***] or [***]
is (i) [***] during [***] or (ii) [***] or [***] in [***] or [***] of [***]
under this Agreement and [***] under this Agreement. The underlying Technology
described in clauses (a) through (e) above, and any Improvement thereto, in each
case to the extent Controlled by ImmunoGen or its Affiliates, are referred to
herein as the “ADC Platform Technology.”

1.3.      “Affiliate” means, with respect to any Person, any other Person that,
directly or indirectly through one or more Affiliates, controls or is controlled
by or is under common control with such Person. For purposes of this definition,
“control” means (a) ownership of fifty percent (50%) or more of the shares of
stock entitled to vote for the election of directors, in the case of a
corporation, or fifty percent (50%) or more of the equity interests in the case
of any other type of legal entity, (b) status as a general partner in the case
of any partnership, or (c) any other arrangement whereby a Person controls or
has the right to control the board of directors or equivalent governing body or
management of another Person. A Person shall be deemed an Affiliate only so long
as it satisfies the foregoing definition.

1.4.      “Antibody” means a polypeptide that Targets an antigen, which
polypeptide comprises: (a) one or more immunoglobulin variable domains; (b) one
or more fragments, variants, modifications or derivatives of such immunoglobulin
variable domains irrespective of origin or source, including antigen binding
portions, fragments (including Fab, Fab’, F(ab’)2, Fv, dAb and CDR fragments),
single chain antibodies (scFv), chimeric antibodies, monospecific antibodies,
bispecific antibodies, multi-specific antibodies, diabodies and other
polypeptides, any of which contain at least a portion of an immunoglobulin
variable domain that is sufficient to confer specific antigen binding to the
polypeptide; or (c) in each case (a) and (b) above, humanized or fully human
versions thereof.

-2-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

1.5.      “Applicable Laws” means all federal, state, local, national and
supra-national laws, statutes, rules, regulations, ordinances and pronouncements
having the effect of law including any rules, regulations, guidelines, or
requirements of Regulatory Authorities, securities regulatory authorities,
national securities exchanges or securities listing organizations that may be in
effect from time to time during the Term and applicable to a particular activity
hereunder.

1.6.      “BLA” means a Biologics License Application under Title 21 of the
United States Code of Federal Regulations.

1.7.      “BPCIA” means Biologics Price Competition and Innovation Act of 2009,
as amended.

1.8.      “Burdened Technology” means any Technology or Patent Rights Controlled
by ImmunoGen as of the Effective Date or during the Term that are necessary or
useful to Develop, make, have made, use, sell, offer for sale, import or
otherwise Commercialize the Licensed Product and are subject to (a) financial or
other contractual obligations to any Third Party, or (b) any requirement that
certain notices or disclosures be made as a result of the use thereof
(collectively, the “Burdened Technology Obligations”), in either case in the
performance of activities under this Agreement, pursuant to an in-license or
similar agreement between ImmunoGen and such Third Party. [***]

1.9.      “Business Day” means any day other than a Saturday, Sunday or other
day on which banking institutions in Boston, Massachusetts or Dublin, Ireland
are required to be closed or are actually closed with legal authorization.

1.10.     “Calendar Quarter” means, with respect to the first such Calendar
Quarter during the Term, the period beginning on the Effective Date and ending
on the last day of the calendar quarter within which the Effective Date falls,
and thereafter each successive period of three (3) consecutive months during the
Term ending on March 31, June 30, September 30, or December 31; except that the
last Calendar Quarter during the Term shall end upon the end of the Term in
accordance with Article 10.

-3-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

1.11.      “Calendar Year” means, with respect to the first such Calendar Year
during the Term, the period beginning on the Effective Date and ending on
December 31 of the calendar year within which the Effective Date falls, and
thereafter each successive period of twelve (12) consecutive months during the
Term commencing on January 1 and ending on December 31; except that the last
Calendar Year during the Term shall end upon the end of the Term in accordance
with Article 10.

1.12.      “Challenge” means any challenge to the [***], or [***] of any of the
Licensed Patent Rights that Cover the Licensed Product (or components or
intermediates thereof) in Development or being Commercialized by Jazz or any of
its Affiliates or Sublicensees at the time of such challenge[***].

1.13.      “Change of Control” of a Party means (a) a merger or consolidation of
such Party or a direct or indirect parent of such Party with a Third Party that
results in the voting securities of such Party or its parent outstanding
immediately prior thereto ceasing to represent at least fifty percent (50%) of
the combined voting power of the surviving entity immediately after such merger
or consolidation, or (b) a transaction or series of related transactions in
which a Third Party, together with its Affiliates, becomes the beneficial owner
of fifty percent (50%) or more of the combined voting power of the outstanding
securities of such Party or its direct or indirect parent, or (c) the sale or
other transfer to a Third Party of all or substantially all of such Party’s
business to which the subject matter of this Agreement relates, except, in each
case, in connection with the issuance of equity securities for financing
purposes or to change the domicile of a Party.

1.14.      “Clearance Date” means the date on which the waiting period (or any
extension thereof) under the HSR Act expires or is terminated.

1.15.      “Co-Development Product” means the Licensed Product that has been
designated as the Co-Development Product pursuant to Section 7.1.

1.16.      “Collaboration and Option Agreement” means that certain Collaboration
and Option Agreement effective as of August 28, 2017 (the “Option Agreement
Effective Date”) by and between ImmunoGen and Jazz, as the same may be amended
from time to time.

-4-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

1.17.      “Commercialization” means, with respect to the Licensed Product or
the ImmunoGen Product, as applicable, any and all activities relating to
commercialization in the Territory, including pre-launch and launch activities,
pricing and reimbursement activities, marketing, medical affairs support, making
or having made for commercial sale, Promoting, detailing, distributing, offering
for sale and selling the Licensed Product or the ImmunoGen Product, as
applicable, importing or exporting the Licensed Product or the ImmunoGen
Product, as applicable, for sale, conducting post-marketing human clinical
trials, reporting of adverse events in patients, and interacting with Regulatory
Authorities regarding any of the foregoing. When used as a verb, “Commercialize”
means to engage in Commercialization and “Commercialized” and “Commercializing”
have corresponding meanings.

1.18.      “Commercially Reasonable Efforts” means, with respect to a Party in
carrying out an obligation or activity under this Agreement, the use of efforts
and resources in respect of such activity in accordance with [***] would [***]
or to which [***], and that is of [***] and [***] as [***] and is [***] as
[***], taking into account [***], the [***] and [***] (including [***] and
[***]), [***] and [***], the [***] involved in [***] and [***] the [***], the
[***] of the [***], and other relevant factors including [***] or [***]. Without
limiting the foregoing, such efforts include: (a) [***] for activities for which
[***] to [***] who are [***] for the [***] and [***] of [***], (b) [***] and
[***] to [***] for [***] such [***], and (c) [***] and [***] and [***] to [***]
with respect to and [***] in [***], in each case, consistent with the [***] by
such Party in [***] of such activity for [***], in each case [***] or [***], at
[***] or [***] and with [***], taking into account [***], including [***] and
[***] of [***] and [***] and [***] (including [***] and [***]).

1.19.      “Competing Product” means any product [***] that (a) [***] and (b) is
not the Licensed Product.

1.20.      “Confidential Information” means (a) with respect to Jazz, all
information and Technology contained in the Licensed Intellectual Property that
is specific to the Licensed Product, (b) with respect to ImmunoGen, (i) all
information and Technology contained in the ADC Platform Technology and (ii) all
information and Technology contained in the Licensed Intellectual Property that
is not specific to the Licensed Product, and (c) with respect to each Party, all
information and Technology that is disclosed hereunder by or on behalf of such
Party (in such

-5-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

capacity, the “Disclosing Party”) to the other Party (in such capacity, the
“Receiving Party”) or to any of the Receiving Party’s or its Affiliates’
employees, consultants or subcontractors (collectively, “Representatives”),
except to the extent that the Receiving Party can demonstrate by written record
or other suitable evidence that such information, (i) as of the date of
disclosure is known to the Receiving Party or its Affiliates other than by
virtue of a prior confidential disclosure by or on behalf of the Disclosing
Party to the Receiving Party or its Affiliates; (ii) as of the date of
disclosure is in, or subsequently enters, the public domain through no fault or
omission of the Receiving Party or its Affiliates or their respective
Representatives; (iii) is obtained by the Receiving Party or its Affiliates from
a Third Party without breach of any duty and without restriction on disclosure
or use; or (iv) is independently developed by or for the Receiving Party or its
Affiliates without reference to or reliance upon any Confidential Information of
the Disclosing Party.

1.21.      “Controlled” means, with respect to any Patent Rights, Technology or
Proprietary Materials, the possession by a Party of the ability to grant a
license or sublicense of or access to such Patent Rights or Technology and the
rights thereto or to supply such Proprietary Materials as contemplated in this
Agreement without violating the terms of any arrangement or agreement between
such Party or its Affiliates and any Third Party in effect at the time of such
grant.

1.22.      “Core Patent Territory” means the [***], and, solely with respect to
[***].

1.23.      “Cover” means, with respect to a Valid Claim within the Licensed
Patent Rights, if, but for the license granted under Section 2.1.1, the making,
having made, use, sale, offer for sale or importation of the Licensed Product
(or any component or intermediate thereof) in a country by Jazz or any of its
Affiliates or Sublicensees in such country would infringe such Valid Claim;
provided,  however, that in determining whether a Valid Claim within the
Licensed Patent Rights “Covers” the Licensed Product under Section 6.4.3, any
Valid Claim within the Licensed Patent Rights that is jointly owned by Jazz (or
any of its Affiliates) with ImmunoGen (or any of its Affiliates) shall be deemed
to be owned solely by ImmunoGen or an Affiliate of ImmunoGen. “Covered” has a
corresponding meaning.

-6-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

1.24.      “Cytotoxic Compound” means a MAY Compound, an IGN Compound, or any
other small molecule compound that inhibits the proliferation of cells within
the body or that causes, facilitates, or contributes to cell death.

1.25.      “Development” means, with respect to the Licensed Product or the
ImmunoGen Product, as applicable, any and all activities relating to discovery,
research and development in connection with seeking, obtaining or maintaining
any Regulatory Approval for the Licensed Product or the ImmunoGen Product, as
applicable, in the Territory, including all pre-clinical research and
development activities, all pre-marketing human clinical studies (including
clinical trial design and operations), test method development and stability
testing, regulatory toxicology studies, formulation, all activities relating to
developing the ability to manufacture the Licensed Product or the ImmunoGen
Product, as applicable, or any component or intermediate thereof (including
process development, manufacturing scale-up, development-stage manufacturing and
quality assurance/quality control development), statistical analysis and report
writing, preparing and filing Drug Approval Applications, reporting of adverse
events in clinical study subjects, and all regulatory affairs related to the
foregoing. When used as a verb, “Develop” and “Developing” mean to engage in
Development and “Develop” and “Developed” have the corresponding meaning.

1.26.      “Development Costs” means Development FTE Costs and Development
Out-of-Pocket Costs reasonably incurred and specifically identifiable by either
Party and its Affiliates in connection with the Development of the Licensed
Product related to seeking, obtaining or maintaining Regulatory Approval in the
United States or the EU, in each case to the extent incurred in accordance with
this Agreement and the applicable Development Plan Budget, unless such costs are
incurred by Jazz pursuant to Section 6.2.2. Development Costs exclude all of the
payments set forth in Sections 6.3 and 6.4 and capital expenditures and costs
attributable to general corporate activities, executive management, investor
relations, treasury services, business development, corporate government
relations, external financial reporting and other overhead activities.

1.27.      “Development FTE” means the equivalent of a scientific, regulatory or
technical individual engaged full time for one (1) Calendar Year (consisting of
a total of [***] hours per year) directly related to Development (and related
manufacturing) activities under the

-7-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

Development Plan or conducted by Jazz pursuant to Section 6.2.2, or any prorated
portion thereof. [***] who [***] hours per year [***] shall be [***].

1.28.      “Development FTE Costs” means the product of the number of
Development FTEs times the Development FTE Rate.

1.29.      “Development FTE Rate” means, for [***]; and for each [***], the
result obtained by [***] by the [***] where [***] is [***], the [***] is the
[***] for the [***] of the [***] and the [***] for the [***] the [***], and the
[***] is the [***] for the [***] the [***]; provided,  however, that in no event
shall the Development FTE Rate for any [***] be less than the [***]. For the
avoidance of doubt, such rate includes all travel expenses. The reported actual
time spent shall be substantiated by a time tracking system consistently
applied.

1.30.      “Development Out-of-Pocket Costs” means all amounts that are included
in the Development Plan Budget (unless incurred by Jazz pursuant to Section
6.2.2) and that are paid or payable to Third Parties in connection with the
Development of the Licensed Product under the Development Plan or pursuant to
Section 6.2.2 related to seeking, obtaining or maintaining Regulatory Approval
in the United States or the EU, including:

(a)        out-of-pocket costs payable by either Party to [***] pursuant to
[***] after the [***] in consideration for the [***] or [***] to [***] that is
[***], including [***] and [***], provided, with respect to any such [***] that
is also [***] that such Party or its Affiliates or licensees is [***], then (i)
with respect to any payment made pursuant to [***] that [***], the [***] of such
payment shall be [***] this Section 1.30(a), (ii) with respect to any payment
made pursuant to [***] that [***], the [***] of such payment shall be [***] this
Section 1.30(a), and (iii) with respect to any other payment made pursuant to
[***] (such as [***]), the out-of-pocket costs to be included in this Section
1.30(a) shall [***] to reflect [***] to which [***] (e.g., if [***], then [***]
of such payment shall be [***] this Section 1.30(a)), further provided that this
Section 1.30(a) shall [***] any costs payable pursuant to [***] after the [***]
that [***] in writing pursuant to [***] to [***] the Licensed Intellectual
Property;

(b)        out-of-pocket costs for conducting clinical studies of the Licensed
Product (to the extent not captured below);

-8-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

(c)        out-of-pocket costs (if not otherwise captured above) of
manufacturing or having manufactured clinical supplies for conducting clinical
studies as set forth in the Development Plan, including, as applicable: (i) the
supply price of clinical supply of the Licensed Product; (ii) costs and expenses
incurred to purchase, package or distribute Third Party comparator or Third
Party combination drugs or devices; and (iii) costs and expenses of disposal of
clinical samples;

(d)        out-of-pocket costs representing fees incurred in connection with
Regulatory Filings with respect to the Licensed Product;

(e)        out-of-pocket costs (if not otherwise captured above) associated with
pre- and post-approval commitments mandated by governmental authorities, to the
extent incurred with respect to the Licensed Product;

(f)        out-of-pocket costs (if not otherwise captured above) incurred in
connection with chemistry, manufacturing and controls (“CMC”) Development or
qualification and validation of manufacturers, and if a [***] is established
[***], the out-of-pocket costs to do so, including the Parties’ costs for
transfer of process and manufacturing technology and analytical methods, scale
up, process and equipment validation, and initial manufacturing licenses,
approvals and inspections;

(g)        out-of-pocket costs (if not otherwise captured above) associated with
activities related to pharmacovigilance, including establishing, updating and
maintaining a global safety database for the Licensed Product; and

(h)        any other out-of-pocket costs incurred for activities specified in
the Development Plan and included in the Development Plan Budget.

For clarity, Development Out-of-Pocket Costs do not include payments for
internal expenses or the out-of-pocket portion, if any, of the following
expenses: salaries or benefits; facilities; utilities; general office or
facility supplies; insurance (other than clinical trial insurance); information
technology, capital expenditures or the like.

-9-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

1.31.      “Development Plan” means the written plan that describes an overall
development strategy and the Development activities to be carried out by the
Parties in the Jazz Territory during each Calendar Year pursuant to this
Agreement, as such written plan may be amended, modified or updated in
accordance with the terms of this Agreement. Such Development Plan, and any
modification, amendment or update thereto, shall set forth, inter alia, the
specific objectives, projected achievement milestones, resource allocation
requirements, applicable budgets, and a proposed timeline for such activities.
[***]

1.32.      “Development Plan Budget” means the budget for activities related to
seeking, obtaining or maintaining Regulatory Approval in the United States and
EU as set forth in the Development Plan on a rolling [***] Calendar Year basis.
[***]

1.33.      “Development Strategy” means the (a) target patient population, (b)
identity of other active ingredients, drugs or drug candidates to be tested or
used, together with the Licensed Product, in combination therapies, and (c)
primary endpoints, in each case for Development of the Licensed Product, as set
forth in the Development Plan as of the Effective Date, unless this Agreement
was entered into pursuant to [***] of the Collaboration and Option Agreement, in
which case as set forth, [***], in (i) the [***] as set forth in [***] under the
Collaboration and Option Agreement, in the case of [***], or as set forth in the
[***] under the Collaboration and Option Agreement [***] or (ii) the Development
Plan in effect under the Collaboration and Option Agreement for the Licensed
Product immediately prior to the deemed exercise of the Jazz Option under such
[***] of the Collaboration and Option Agreement.

1.34.      “Disclosure Letter”  means the letter delivered by ImmunoGen to Jazz
on the Schedule Revision Date in connection with this Agreement.

1.35.      “Drug Approval Application” means, with respect to the Licensed
Product in a particular country or region, an application for Regulatory
Approval to market and sell the Licensed Product in such country or region,
including: (a) an NDA or sNDA; (b) a BLA or BLA supplement; (c) a counterpart of
an NDA, sNDA, BLA or BLA supplement, including any MAA, in any country or region
in the Territory outside the U.S.; and (d) all supplements and amendments to any
of the foregoing.

-10-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

1.36.      “Effective Date” shall be, unless this Agreement has been terminated
by either Party pursuant to Section 10.4 or by Jazz pursuant to Section 10.5
prior to the [***] Business Day following the Schedule Revision Date, the
earlier of (i) [***] Business Days after the Schedule Revision Date and (ii) the
date that Jazz notifies ImmunoGen that it has determined that no HSR Filing is
required in connection with this Agreement pursuant to Section 14.16.1.

1.37.      “EMA” means the European Medicines Agency and any successor agency or
authority thereto.

1.38.      “Employment Cost Index” means [***] published from time to time by
the [***].

1.39.      “EU” means the economic, scientific and political organization of
member states of the European Union as it is constituted as of the effective
date of the Collaboration and Option Agreement, whether or not any such member
states may leave the European Union following such date (including the United
Kingdom), and any member states that may be added to the European Union from
time to time following such date.

1.40.      “Exclusive License Agreement” means any license agreement, other than
this Agreement, pursuant to which ImmunoGen grants Jazz an exclusive license as
a result of Jazz’s exercise of a Jazz Option under the Collaboration and Option
Agreement.

1.41.      “FDA” means the United States Food and Drug Administration and any
successor agency or authority thereto.

1.42.      “FDCA” means the United States Food, Drug and Cosmetic Act, as
amended (21 U.S.C. § 301 et seq.), and the rules and regulations promulgated
thereunder.

1.43.      “First Commercial Sale” means, (a) with respect to the Licensed
Product in any country in the Territory, the first sale of the Licensed Product
by or under the authority of Jazz, an Affiliate of Jazz, or their Sublicensees
to a Third Party in that country following Regulatory Approval of the Licensed
Product in that country or, if no such Regulatory Approval or similar approval
is required, the date on which the Licensed Product is first commercially
launched in such country, and (b) with respect to any ImmunoGen Product in any
country in the Territory, the

-11-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

first sale of the ImmunoGen Product by or under the authority of ImmunoGen, an
Affiliate of ImmunoGen, or their ImmunoGen Licensees to a Third Party in that
country following Regulatory Approval of such ImmunoGen Product in that country
or, if no such Regulatory Approval or similar approval is required, the date on
which such ImmunoGen Product is first commercially launched in such country;
provided that “First Commercial Sale” shall not include: [***].

1.44.      “Future Acquirer” means a Third Party acquirer in any Change of
Control transaction involving either Party, and such Third Party acquirer’s
Affiliates other than the applicable acquired Party or any of its Affiliates
prior to such Change of Control.

1.45.      “GCP” means all good clinical practices under Title 21 of the United
States Code of Federal Regulations, as amended from time to time, and comparable
laws and regulations promulgated by the EMA or other Regulatory Authority
applicable to the Territory, as they may be updated from time to time, including
applicable quality guidelines promulgated under the ICH.

1.46.      “Generic Competition” means, with respect to the Licensed Product in
any country in the Territory, that one or more Generic Products are or become
commercially available in such country, and such Generic Products have a market
share (in the aggregate) of [***] or greater in a Calendar Quarter provided that
such Generic Competition shall be deemed to exist only for so long as unit
volume sales of such Generic Products in such country, as a percentage of total
unit volume sales of Licensed Products and such Generic Products, during any
Calendar Quarter thereafter exceeds [***], and, if such Generic Product market
share falls below [***] in such country, Generic Competition shall not
thereafter be deemed to exist until the unit volume market share of Generic
Products again exceeds [***]. Market share is based on the aggregate market in
such country of the Licensed Product and the Generic Products, based on units of
the Licensed Product sold and units of such Generic Products sold in the
aggregate, as reported by Quintiles/IMS Health, or if such data are not
available, such other reliable data source as reasonably agreed by the Parties.

1.47.      “Generic Product” means, on a country-by-country basis, any
pharmaceutical or biological product (a) that contains (i) an identical active
ingredient as the Licensed Product, or (ii) a [***] as the Licensed Product, as
[***] is used in [***], and subject to the factors set forth

-12-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

in [***], (b) for which Regulatory Approval is obtained by [***], (c) is
approved for use in such country pursuant to a Regulatory Approval process
governing approval of [***], or an equivalent process for Regulatory Approval in
any country outside the United States, or any other equivalent provision that
comes into force, or is the subject of a notice with respect to the Licensed
Product under [***] or any other equivalent provision that comes into force
[***], and (d) is sold in the same country (or is commercially available in the
same country via import from another country) as the Licensed Product by any
Third Party that is [***].

1.48.      “GLP” means all good laboratory practices under Title 21 of the
United States Code of Federal Regulations, as amended from time to time, and
comparable laws and regulations promulgated by the EMA or other Regulatory
Authority applicable to the Territory, as they may be updated from time to time,
including applicable quality guidelines promulgated under the ICH.

1.49.      “GMP” means all good manufacturing practices under Title 21 of the
United States Code of Federal Regulations, as amended from time to time and
comparable laws and regulations applicable to the manufacture and testing of
pharmaceutical materials promulgated by the EMA or other Regulatory Authority
applicable to the Territory, as they may be updated from time to time, including
applicable quality guidelines promulgated under the ICH.

1.50.      “HSR Act” means (a) the Hart-Scott-Rodino Antitrust Improvements Act
of 1976, as amended, and the rules promulgated thereunder and (b) any equivalent
antitrust laws or regulations outside the United States.

1.51.      “HSR Filing” means (a) filings with the United States Federal Trade
Commission and the Antitrust Division of the United States Department of Justice
of a Notification and Report Form for Certain Mergers and Acquisitions (as that
term is defined in the HSR Act) with respect to the subject matter of this
Agreement, together with all required documentary attachments thereto and (b)
any equivalent antitrust filings with governmental authorities outside the
United States.

1.52.      “ImmunoGen Accounting Standards” means US GAAP (United States
Generally Accepted Accounting Principles), as generally and consistently applied
throughout ImmunoGen’s organization.

-13-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

1.53.      “ImmunoGen Generic Competition” means, with respect to the ImmunoGen
Product in any country in the Territory, that one or more ImmunoGen Generic
Products are or become commercially available in such country, and such
ImmunoGen Generic Products have a market share (in the aggregate) of [***] or
greater in a Calendar Quarter, provided that such ImmunoGen Generic Competition
shall be deemed to exist only for so long as unit volume sales of such ImmunoGen
Generic Products in such country, as a percentage of total unit volume sales of
ImmunoGen Products and such ImmunoGen Generic Products, during any Calendar
Quarter thereafter exceeds [***], and, if such ImmunoGen Generic Product market
share falls below [***] in such country, ImmunoGen Generic Competition shall not
thereafter be deemed to exist until the unit volume market share of ImmunoGen
Generic Products again exceeds [***]. Market share is based on the aggregate
market in such country of the ImmunoGen Product and the ImmunoGen Generic
Products, based on units of the ImmunoGen Product sold and units of such
ImmunoGen Generic Products sold in the aggregate, as reported by Quintiles/IMS
Health, or if such data are not available, such other reliable data source as
reasonably agreed by the Parties.

1.54.      “ImmunoGen Generic Product” means on a country-by-country basis, any
pharmaceutical or biological product (a) that contains (i) an identical active
ingredient as the ImmunoGen Product, or (ii) a [***] as the ImmunoGen Product,
as [***] is used in [***], and subject to the factors set forth in [***], (b)
for which Regulatory Approval is obtained by [***], (c) is approved for use in
such country pursuant to a Regulatory Approval process governing approval of
[***], or an equivalent process for Regulatory Approval [***], or any other
equivalent provision that comes into force, or is the subject of a notice with
respect to the ImmunoGen Product under [***] or any other equivalent provision
that comes into force [***], and (d) is sold in the same country (or is
commercially available in the same country via import from another country) as
the ImmunoGen Product by any Third Party that is [***].

1.55.      “ImmunoGen Licensee” means any Third Party to which ImmunoGen or its
Affiliates grants a license of the rights to Develop, make or Commercialize
ImmunoGen Products.

1.56.      “ImmunoGen Net Sales” means Net Sales applied to the ImmunoGen
Product sold by ImmunoGen or its Affiliates or ImmunoGen Licensees mutatis
mutandis.

-14-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

1.57.      “ImmunoGen Opt-In Data Package” means with respect to the Licensed
Product, a written package containing at least [***] and any of the following
information solely to the extent (i) not already provided by ImmunoGen to Jazz
under the Early Stage Option Data Package, Late Stage Option Data Package or any
Interim Data Package (each as defined in the Collaboration and Option Agreement)
and (ii) not included in [***] provided by Jazz to ImmunoGen: (a) the final ICH
compliant CSRs of all [***] with the Licensed Product, (b) the [***] of all
Licensed Product [***], (c) [***] of all [***] for the Licensed Product, (d)
[***] of all [***] on the Licensed Product, (e) all [***] from all [***] with
the Licensed Product, including the [***] and [***] for the [***] or [***] in
[***] and [***] with [***] in [***] and [***], (f) (i) a list of [***] and
[***], (ii) (1) to the extent permitted by the [***] after [***] of [***] to
[***] such [***] (which [***]), [***] of [***] and [***] to [***] of [***] in
connection with the Licensed Product [***], or (2) to the extent [***] of [***]
are [***] by the [***] after such [***], [***] of [***] from [***], and (iii)
(1) to the extent permitted by the [***] after [***] of [***] to [***] such
[***] (which [***]), [***] of [***] for the Licensed Product [***], or (2) to
the extent [***] of [***] are [***] by the [***] after such [***], [***] from
[***], (g) copies of the [***] in connection with all [***], (h) [***] that all
[***] are [***] (if [***] listed in the [***]) or [***] (if [***] as [***]), (i)
a [***] that the [***] is [***] and [***], (j) all [***], (k) a [***] of [***],
(l) for [***], (m) if there are any [***] or [***] since [***] or [***], a [***]
showing [***] to the [***] or [***] as appropriate, (n) the [***] for the
Licensed Product, (o) all [***] regarding the Licensed Product, and (p) a list
of any [***] with the Licensed Product with a [***].

1.58.      “ImmunoGen Opt-In Right” means ImmunoGen’s right to opt-in to the
co-development and co-commercialization in the Co-Development Territory of one
(1) Jazz Product, which may be the Licensed Product or another former
Collaboration Product that is the focus of an Exclusive License Agreement.

1.59.      “ImmunoGen Product” means the Licensed Product or Co-Development
Product with respect to which this Agreement has been terminated for any reason.

1.60.      “ImmunoGen Standard Exchange Rate Methodology” means, with respect to
amounts invoiced in U.S. Dollars, all such amounts shall be expressed in U.S.
Dollars. With respect to amounts invoiced in a currency other than U.S. Dollars,
all such amounts shall be expressed

-15-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

both in the currency in which the amount was invoiced and in the U.S. Dollar
equivalent. The U.S. Dollar equivalent shall be calculated using ImmunoGen’s
then-current standard exchange rate methodology which is in accordance with the
ImmunoGen Accounting Standards applied in its external reporting for the
conversion of foreign currency sales into U.S. Dollars or, in the case of
ImmunoGen Licensees, such similar methodology, consistently applied.

1.61.      “IND” means (a) an Investigational New Drug Application (as defined
in the FDCA and regulations promulgated thereunder) or any successor application
or procedure required to initiate clinical testing of the Licensed Product in
humans in the United States; (b) a counterpart to an Investigational New Drug
Application that is required in any other country or region in the Territory
before beginning clinical testing of the Licensed Product in humans in such
country or region; and (c) all supplements and amendments to any of the
foregoing.

1.62.      “Independent Patent Counsel” means an outside patent counsel
reasonably acceptable to both Parties who (and whose firm) is not at the time of
the dispute, and was not at any time during the [***]-year period preceding the
dispute, performing legal services of any nature for either of the Parties or
their respective Affiliates or Sublicensees and whose firm did not, at any time,
employ either of the Parties’ chief patent counsels (or persons with similar
responsibilities).

1.63.      “IGN Compound” means any and all [***] benzodiazepine compounds,
whether produced from a botanical source, natural fermentation, chemical
synthesis or otherwise, including all analogs, variants, fragments or
derivatives of any of the foregoing, in each case owned or Controlled by
ImmunoGen.

1.64.      “Jazz Accounting Standards” means US GAAP (United States Generally
Accepted Accounting Principles), as generally and consistently applied
throughout Jazz’s organization.

1.65.      “Jazz Intellectual Property” means any Patent Rights or Technology
Controlled by Jazz as of the Effective Date or that becomes Controlled by Jazz
during the Term (including Jazz Product Technology and Jazz’s interest in any
Joint Product Technology) that is necessary or useful for ImmunoGen to Develop,
make, have made or use the Licensed Product to the extent that

-16-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

ImmunoGen has the obligation to conduct such activities in accordance with the
terms of this Agreement. For purposes of clarity, Jazz Intellectual Property
excludes all ADC Platform Improvements assigned to ImmunoGen pursuant to Section
9.1.3.

1.66.      “Jazz Option” has the meaning ascribed to such term in the
Collaboration and Option Agreement.

1.67.      “Jazz Product Technology” means any Product Technology (other than
Joint Product Technology), the inventors of which include one or more employees
of, or other Persons obligated to assign inventions to, Jazz or any of its
Affiliates.

1.68.      “Jazz Standard Exchange Rate Methodology” means, with respect to
amounts invoiced in U.S. Dollars, all such amounts shall be expressed in U.S.
Dollars. With respect to amounts invoiced in a currency other than U.S. Dollars,
all such amounts shall be expressed both in the currency in which the amount was
invoiced and in the U.S. Dollar equivalent. The U.S. Dollar equivalent shall be
calculated using Jazz’s then-current standard exchange rate methodology which is
in accordance with the Jazz Accounting Standards applied in its external
reporting for the conversion of foreign currency sales into U.S. Dollars or, in
the case of Sublicensees, such similar methodology, consistently applied.

1.69.      “Jazz Territory” means the entire world; provided,  however, that if
ImmunoGen exercises the ImmunoGen Opt-In Right with respect to the Licensed
Product under this Agreement and has not exercised the ImmunoGen Opt-Out Right,
then the “Jazz Territory” shall exclude the Co-Development Territory.

1.70.      “Joint Product Patent” means any Patent Rights claiming Joint Product
Technology.

1.71.      “Joint Product Technology” means any Product Technology the inventors
of which include both (a) one or more employees of, or other Persons obligated
to assign inventions to, ImmunoGen or any of its Affiliates, and (b) one or more
employees of, or other Persons obligated to assign inventions to, Jazz or any of
its Affiliates.

-17-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

1.72.      “Knowledge” means the actual knowledge [***] of all ImmunoGen
“executive officers” (as defined in Rule 3b-7 promulgated under the Securities
Exchange Act of 1934, as amended) and [***].

1.73.      “Licensed Intellectual Property” means, collectively the Licensed
Patent Rights and the Licensed Technology.

1.74.      “Licensed Jazz Intellectual Property” means, collectively, the
Licensed Jazz Patent Rights and the Licensed Jazz Technology.

1.75.      “Licensed Jazz Patent Rights” means any Patent Rights Controlled by
Jazz or its Affiliates (a) that (i) arise out of any activities conducted under
this Agreement or any Exclusive License Agreement and (ii) are necessary or
useful to Develop, make, have made, use, sell, offer for sale, import and
otherwise Commercialize the ImmunoGen Product or (b) that Jazz or its Affiliates
actually uses or has used to Develop, make, have made, use, sell, offer for
sale, import and otherwise Commercialize the Licensed Product pursuant to this
Agreement prior to the Licensed Product becoming an ImmunoGen Product.

1.76.      “Licensed Jazz Technology” means any and all Technology Controlled by
Jazz or its Affiliates (a) that (i) arises out of any activities conducted under
this Agreement or any Exclusive License Agreement and (ii) is necessary or
useful to Develop, make, have made, use, sell, offer for sale, import and
otherwise Commercialize the ImmunoGen Product or (b) that Jazz or its Affiliates
actually uses or has used to Develop, make, have made, use, sell, offer for
sale, import and otherwise Commercialize the Licensed Product pursuant to this
Agreement prior to the Licensed Product becoming an ImmunoGen Product.

1.77.      “Licensed Patent Rights” means any Patent Rights that are Controlled
by ImmunoGen or its Affiliates as of the Effective Date or become Controlled by
ImmunoGen or its Affiliates during the Term (including ImmunoGen’s interest in
any Patent Rights claiming Joint Product Technology) that are necessary or
useful to Develop, make, have made, use, sell, offer for sale, import or
otherwise Commercialize the Licensed Product, other than any Patent Rights
excluded from Licensed Patent Rights pursuant to Section 6.2.3. The Licensed
Patent Rights as of the Schedule Revision Date are listed in Section 1.77 of the
Disclosure Letter.

-18-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

1.78.      “Licensed Product” means a product containing [_____]2, whether alone
or in combination with one or more other active ingredients, in any dosage form,
formulation or strength.

1.79.      “Licensed Target” means [_____]3.

1.80.      “Licensed Technology” means any and all Technology that is Controlled
by ImmunoGen or its Affiliates as of the Effective Date, or becomes Controlled
by ImmunoGen or its Affiliates during the Term (including ImmunoGen’s interest
in any Joint Product Technology) that is necessary or useful to Develop, make,
have made, use, sell, offer for sale, import and otherwise Commercialize the
Licensed Product, other than any Technology excluded from Licensed Technology
pursuant to Section 6.2.3.

1.81.      “Linker” means any compound or composition [***] under this Agreement
or [***] under this Agreement as useful to link a Cytotoxic Compound and an
Antibody together to form a conjugate of such Cytotoxic Compound with the
Antibody.

1.82.      “MAA” means an application filed with the relevant Regulatory
Authorities in the EU seeking Regulatory Approval to market and sell the
Licensed Product in the EU or any country or territory therein.

1.83.      “Material Adverse Event”  means an event, occurrence, development or
change within the reasonable control of ImmunoGen or its Affiliates that (a) is
reflected in any schedule delivered to Jazz pursuant to the proviso in the first
sentence of Section 12.1 after the Signing Date and less than three (3) days
following the Clearance Date or (b) should have been, but was not, included in a
schedule to Section 12.1 as of the Signing Date (each of (a) and (b), an
“Effect”) and that, individually or when taken together with all other Effects,
has or would reasonably be expected to have a material adverse effect on [***].

 

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

2 Insert Collaboration Product with respect to which the Jazz Option has been
exercised.

3 Insert the common name and UniProtKB/Swiss-Prot accession number of the Target
that the Licensed Product Targets.

-19-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

1.84.      “Material Base Budget Increase” means a proposed increase in the
Development Plan Budget for a given Calendar Year (the “Reference Year”) that
would cause both (i) the [***] to exceed [***] of the [***] and (ii) the sum of
the [***] plus the [***] to exceed the sum of the [***]; provided, that, in each
case of clause (i) and (ii) above, in the event the [***] were [***], then the
[***] shall be [***] to determine whether there has been a Material Base Budget
Increase. [***] means the Development Plan Budget included with the Development
Plan [***], updated [***] for each [***] beyond the [***]-year period covered by
such Development Plan Budget with the costs required to [***].

1.85.      “MAY Compound” means any and all maytansinoid compounds (including
maytansinol, ansamitocins, DM1 and DM4), whether produced by a botanical source,
natural fermentation, chemical synthesis or otherwise, including all variants,
fragments, or derivatives of any of the foregoing, in each case owned or
Controlled by ImmunoGen.4

1.86.      “NDA” means a New Drug Application (as more fully described in 21
C.F.R. Parts 314 et seq. or its successor regulation).

1.87.      “Net Sales” means, as to each Calendar Quarter during the Term, the
gross invoiced sales prices charged for the Licensed Product sold by Jazz or its
Affiliates or Sublicensees to Third Parties throughout the Territory during such
Calendar Quarter in bona fide arm’s length transactions, as determined in
accordance with the Jazz Accounting Standards, less the following amounts
incurred or paid by Jazz or its Affiliates or Sublicensees during such Calendar
Quarter with respect to sales of the Licensed Product regardless of the Calendar
Quarter in which such sales were made:

(a)        trade, quantity and cash discounts actually allowed or taken;

(b)        discounts, coupons, refunds, rebates, chargebacks, co-pay provided by
or on behalf of the selling party, retroactive price adjustments, and any other
allowances actually allowed or given which effectively reduce the net selling
price;

 

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

4 Include if Licensed Product is a DMx product only.

-20-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

(c)        credits or allowances actually given or made for rejection or return
of previously-sold Licensed Product;

(d)        any charges for freight, postage, shipping, warehousing, distribution
or transportation, or for insurance, in each case to the extent borne by Jazz,
or its Affiliates or Sublicensees;

(e)        any sales, credits or allowances given or made with respect to the
Licensed Product for wastage replacement, indigent patient, or clinical trials;

(f)        the standard inventory cost of devices used for dispensing or
administering the Licensed Product that are shipped with the Licensed Product
and included in the gross invoiced sales price;

(g)        any tax, tariff, duty or government charge (including any sales,
value added, excise or similar tax or government charge, but excluding any
income tax) levied on the sale, transportation or delivery of the Licensed
Product and borne by Jazz, or its Affiliates or Sublicensees without
reimbursement from any Third Party;

(h)        wholesaler inventory management fees and allowances actually paid or
given; and

(i)         other reductions or specifically identifiable amounts deducted for
reasons similar to those listed above in accordance with the Jazz Accounting
Standards.

Net Sales shall not include sales or transfers among Jazz and its Affiliates and
Sublicensees where the Licensed Product is intended for subsequent sale to the
end user. All the foregoing elements of Net Sales calculations shall be
determined from the books and records of Jazz and its Affiliates and
Sublicensees, as applicable, maintained in accordance with the Jazz Accounting
Standards, or in the case of Sublicensees, such similar accounting principles,
consistently applied.

In the event the Licensed Product is sold as a component of a combination or
bundled product that consists of the Licensed Product together with one or more
other therapeutically active products (a “Combination”), the Net Sales from the
Combination, for the purposes of determining

-21-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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royalty payments hereunder, shall be determined by multiplying the Net Sales of
the Combination (as defined in the standard Net Sales definition above) by the
fraction A/(A+B), where A is the weighted average per unit sale price of the
Licensed Product when sold separately in finished form in the country in which
the Combination is sold in similar volumes and of the same class, purity,
potency and dosage form, and B is the weighted average per unit sale price of
the other product(s) included in the Combination when sold separately in
finished form in the country in which the Combination is sold in similar volumes
and of the same class, purity, potency and dosage form.

In the event that the weighted average per unit sale price of the Licensed
Product can be determined but the weighted average per unit sale price of the
other product(s) included in the Combination cannot be determined, Net Sales for
purposes of determining royalty payments shall be calculated by multiplying the
Net Sales of the Combination (as defined in the standard Net Sales definition
above) by the fraction A/C, where A is the weighted average sale price of the
Licensed Product when sold separately in finished form in the country in which
the Combination is sold in similar volumes and of the same class, purity,
potency and dosage form, and C is the weighted average per unit sale price of
the Combination.

In the event that the weighted average per unit sale price of the other
product(s) included in the Combination can be determined but the weighted
average per unit sale price of the Licensed Product in similar volumes and of
the same class purity, potency and dosage form as in the Combination cannot be
determined, Net Sales for purposes of determining royalty payments shall be
calculated by multiplying Net Sales of the Combination (as defined in the
standard Net Sales definition above) by a fraction determined by the following
formula: one (1) minus (B/C) where B is the weighted average per unit sale price
of the other product(s) included in the Combination when sold separately in
finished form in the country in which the Combination is sold in similar volumes
and of the same class, purity, potency and dosage form and C is the weighted
average per unit sale price of the Combination.

In the event that such average per unit sale price cannot be determined for the
Licensed Product, on the one hand, and all other product(s) included in the
Combination, on the other, Net Sales for the purposes of determining royalty
payments shall be [***].

-22-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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The weighted average per unit sale price for both the Licensed Product, on the
one hand, and all other product(s) included in the Combination, on the other,
shall be calculated [***] for country [***] and such price shall be used during
[***]. When determining the weighted average per unit sale price in a particular
country of the Licensed Product, other product(s), or Combination, such weighted
average per unit sale price shall be calculated by dividing sales dollars
(translated into U.S. Dollars using the Jazz Standard Exchange Rate Methodology)
by the units sold in such country during the [***] months (or the number of
months in which sales occurred [***]) of the [***] for the respective Licensed
Product, other product(s), or Combination. In the [***], a [***] will be used
for the Licensed Product, other product(s), or Combination. Any over- or
under-payment due to a difference between [***].

1.88.      “Patent Rights” means the rights and interests in and to any and all
issued patents and pending patent applications (including inventor’s
certificates, applications for inventor’s certificates, statutory invention
registrations, applications for statutory invention registrations, utility
models and any foreign counterparts thereof) in any country or jurisdiction in
the Territory, including any and all reissues, confirmations, registrations,
validations, provisionals, non-provisionals, substitutions, continuations,
continuations-in-part, divisionals and other continuing applications, extensions
or restorations by existing or future extension or restoration mechanisms,
including patent term extension, supplementary protection certificates or the
equivalent, renewals, and all letters patent on any of the foregoing, and any
and all reissues, reexaminations, additions, extensions, confirmations,
registrations and patents of addition on any of the foregoing.

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

1.90.      “PHSA” means the Public Health Service Act, as amended (42 U.S.C. §
201 et seq.).

1.91.      “Platform Patent Rights” means all Licensed Patent Rights that are
[***].

-23-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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1.92.      “Product Patent Rights” means all Patent Rights Controlled by
ImmunoGen or its Affiliates as of the Effective Date or during the Term [***]
(all of the foregoing being hereinafter referred to as “Product Patent Claims”),
including the Patent Rights [***].

1.93.      “Product Technology” means any Technology (other than ADC Platform
Improvements) that is invented, conceived, or developed by or on behalf of a
Party or an Affiliate of a Party, in conducting activities pursuant to this
Agreement.

1.94.      “Promoting” means engaging in activities, including physicians
meetings, professional education, detailing, congresses, opinion leader
management, advertising and distributing samples of a product, that are
typically undertaken by a pharmaceutical company’s sales force to implement
marketing plans and strategies aimed at encouraging the appropriate use of a
particular product.

1.95.      “Proprietary Materials” means any tangible chemical, biological or
other research materials (other than the Licensed Product or components thereof)
that are furnished by or on behalf of one Party to the other Party in connection
with this Agreement, regardless of whether such materials are specifically
designated as proprietary by the transferring Party. Any mutant, derivative,
progeny or improvement made to or from a Party’s Proprietary Materials shall be
considered to be that Party’s Proprietary Materials. For clarity, Proprietary
Materials excludes any materials provided by ImmunoGen to Jazz pursuant to
Section 5.2.

1.96.      “Regulatory Approval” means any and all approvals (including any
pricing and reimbursement approvals, as applicable), product and establishment
licenses, registrations and authorizations of any kind of any Regulatory
Authority necessary for the Development, manufacture, use or Commercialization
of the Licensed Product (or any component thereof) for use in any country or
other jurisdiction in the Territory. The term “Regulatory Approval” includes any
approval by a Regulatory Authority of any Drug Approval Application.

1.97.      “Regulatory Authority” means the FDA or any counterpart to the FDA
outside the United States, or any other national, supra-national, federal,
regional, state, local, municipal, or provincial regulatory agency, department,
bureau, commission, council or other governmental

-24-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

entity with authority over the distribution, importation, exportation,
manufacture, production, use, storage, transport, clinical testing or sale of
the Licensed Product.

1.98.      “Regulatory Filings” means, collectively: (a) all INDs, NDAs, BLAs,
CTAs, establishment license applications, drug master files, applications for
designation as an “Orphan Product” under the Orphan Drug Act, and all other
similar submissions (including MAAs and counterparts to any of the foregoing in
any country or region in the Territory) as may be required by any Regulatory
Authority for the Development, manufacture, use or Commercialization of the
Licensed Product in the Territory; (b) all supplements and amendments to any of
the foregoing; and (c) all data and other information contained in, and
correspondence relating to, any of the foregoing.

1.99.      “Schedule Revision Date” means the [***] Business Day following
ImmunoGen’s receipt of notice from the applicable government agency of the
Clearance Date.

1.100.    “Sublicensee” means any Third Party to which Jazz or its Affiliates
grants a sublicense of the rights granted to Jazz pursuant to this Agreement.

1.101.    “Target” means, when used as a noun, a protein described by a unique
UniProtKB/Swiss-Prot accession number (and all fragments, mutations and splice
variants thereof).

1.102.    “Target” or “Targeting” means, when used as a verb to describe the
relationship between a molecule and a Target, that the molecule’s primary
intended mechanism of action is to specifically bind to the Target (or a portion
thereof).

1.103.    “Technical Transfer Materials” means all information, data,
documentation, materials, and other embodiments of Technology Controlled by
ImmunoGen that are necessary or useful to enable Jazz to establish or have
established manufacturing and supply capabilities for the Licensed Product and
each component necessary for the manufacture thereof (including the conjugation
of the Antibody to the Cytotoxic Compound) in compliance with the applicable
specifications for Development and Commercialization use and the generally
accepted practices

-25-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

and principles for such technology transfer, including the methods used by
ImmunoGen to manufacture the Licensed Product immediately prior to the Signing
Date.

1.104.    “Technology” means, collectively, all inventions, discoveries,
improvements, trade secrets and proprietary methods or materials, whether or not
patentable, including macromolecular sequences, data, formulations, processes,
techniques, know-how, information and results (including negative results).

1.105.    “Territory” means all countries and jurisdictions of the world.

1.106.    “Third Party” means any Person other than ImmunoGen, Jazz and their
respective Affiliates.

1.107.    “Valid Claim” means any claim (including a process, use, or
composition of matter claim) (a) in an issued and unexpired patent within the
Licensed Patent Rights that (i) has not been finally cancelled, withdrawn,
abandoned or rejected by any administrative agency or other body of competent
jurisdiction, and (ii) has not been revoked, held invalid, or declared
unpatentable or unenforceable in a decision of a court or other body of
competent jurisdiction that is unappealable or unappealed within the time
allowed for appeal, and (iii) has not been rendered unenforceable through
reissue, disclaimer or otherwise, and (iv) has not been disclaimed or otherwise
dedicated to the public, and (v) is not lost through an interference proceeding,
inter partes review, post-grant review or opposition, and any appeals therefrom;
or (b) in any [***] within the Licensed Patent Rights that [***]. Anything
contained in this Agreement to the contrary notwithstanding, if [***] is [***]
from or otherwise [***] in [***] of a claim within an issued and unexpired U.S.
patent included in the Licensed Patent Rights as a result of the operation of
[***] or [***], such claim shall remain a Valid Claim for all purposes under
this Agreement unless such [***] or [***] is attributable to [***].

1.108.    “Vyxeos Third Party Combination Trials” means any clinical trial for
which Jazz or its Affiliate provides to a Third Party Jazz’s proprietary
product, Vyxeos, or any other product or product candidate that is proprietary
to Jazz or its Affiliates but for which Jazz and its Affiliates are not the
sponsor and do not provide any additional support or funding.

-26-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

1.109.    Additional Definitions. In addition, each of the following definitions
shall have the respective meanings set forth in the section of the Agreement
indicated below:

 

 

Definition

Section

Abbreviated Financial Statements

6.9.1

Active Development

4.1.2

ADC Platform Technology

1.2

Additional Development Activities

6.2.2(a)

Additional Development Activities Budget

6.2.2(a)

Agreement

Recitals

Alliance Managers

3.1.1

Anti-Corruption Laws

12.4

Applicant

9.5.2

Applicant Response

9.5.3(b)

Arbitration

14.13.2(a)

Audited Party

6.8.2

Base Budget

1.84

Base Development FTE Rate

1.29

Biosimilar Application

9.5.1

BLA Notice

7.1

Burdened Technology Agreement

6.2.3

Burdened Technology Obligations

1.8

Burdened Technology Payments

6.2.3

Challenge Jurisdiction

6.4.6

Challenged Patent Rights

6.4.6

[***]

[***]

[***]

[***]

Clinical and Regulatory Transfer Plan

4.6

CMC

1.30(f)

Combination

1.87

Competing Program

2.3.2

Covered Results

8.3

-27-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

 

 

Definition

Section

Development Costs Report

6.2.1

Development Plan Budget

1.31

Disclosing Party

1.20

Dispute

14.13.1

Divestiture

2.3.2

DOJ

14.16.1

Exchange Act

6.9.1

Financial Statements

6.9.1

FTC

14.16.1

Immediate Patent Infringement Action

9.5.3(d)

ImmunoGen

Recitals

ImmunoGen Indemnitees

13.1.1

ImmunoGen Product Effective Date

11.1

ImmunoGen’s Qualified Counsel

9.5.2

ImmunoGen Royalty Term

11.3.1

ImmunoGen Third Party Payments

11.3.2

Improvement

1.2

Indemnified Party

13.2

Indemnifying Party

13.2

Infringement

9.4.1

Infringement Notice

9.4.1

Infringed Patent List

9.5.3(d)

Initial Patent List

9.5.3(a)

Inspected Party

4.1.5

Inspecting Party

6.8.2

Jazz

Recitals

Jazz Indemnitees

13.1.2

Jazz Response

9.5.3(c)

JDC

3.3.1

JIPC

3.4

JSC

3.2.1

 

-28-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

 

 

Definition

Section

[***]

[***]

[***]

[***]

Losses

13.1.1

Monies

9.4.7

Option Agreement Effective Date

1.16

Party/Parties

Recitals

Permitted Third Party Service Providers

2.1.4

Premarket Notice

9.5.4(b)

Product Patent Claims

1.92

Proposed Biosimilar Product

9.5.1

Proposed Initial Patent List

9.5.3(a)

Proposed Jazz Response

9.5.3(c)

Receiving Party

1.20

Reference Year

1.84

Representatives

1.20

Royalty Term

6.5

[***]

[***]

[***]

[***]

SEC

8.2.3

SEC Documents

6.9.1

Securities Act

6.9.1

Senior Officers

14.13.1

Signing Date

Recitals

Technology Transfer Plan

5.2

Term

10.1

Third Party Claims

13.1.1

Third Party Payments

6.4.2

Tribunal

14.13.2(a)

Unauthorized Use

4.5

US GAAP

6.9.1

Wind-Down Period

10.6.2

 

-29-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

2.         GRANT OF RIGHTS

2.1.      License Grants.

2.1.1.      Exclusive License to Jazz. Subject to the terms and conditions of
this Agreement and commencing as of the Effective Date, ImmunoGen shall, and
does hereby, grant to Jazz an exclusive, royalty-bearing right and license,
including the right to grant sublicenses as described in Section 2.1.3, under
the Licensed Intellectual Property, to Develop, make, have made, use, sell,
offer for sale, import and otherwise Commercialize the Licensed Product for all
uses in the Territory.

2.1.2.      Non-Exclusive License to ImmunoGen. Subject to the terms and
conditions of this Agreement, if the Parties agree that ImmunoGen will perform
certain activities under this Agreement then Jazz shall, and does hereby, grant
to ImmunoGen a non-exclusive, non-transferable (except as expressly permitted in
this Agreement), royalty-free, fully paid right and license, under any Jazz
Intellectual Property, solely for ImmunoGen to perform its obligations under
this Agreement in connection with Developing, making, having made, or using the
Licensed Product in accordance with this Agreement.

2.1.3.      Rights to Sublicense. Jazz shall have the right to grant sublicenses
under the license rights granted to it under Section 2.1.1 with respect to the
Licensed Product to any Affiliate, and Jazz and its Affiliates shall have the
right to grant sublicenses under the license rights granted to it under Section
2.1.1 (or in the case of Affiliates of Jazz, sublicensed to it under this
Section 2.1.3) with respect to the Licensed Product to any Sublicensee,
provided, that: [***].

2.1.4.      Permitted Third Party Service Providers. Each Party and its
Affiliates shall have the right, subject to the conditions set forth herein, to
engage one or more Third Parties (“Permitted Third Party Service Providers”) as
subcontractors to perform designated functions in connection with its activities
under this Agreement (including transferring or disclosing Licensed Intellectual
Property, the Jazz Intellectual Property and ImmunoGen’s Proprietary Materials
as may be necessary or useful for such Permitted Third Party Service Provider to
perform

-30-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

such designated functions); provided, that (a) ImmunoGen [***]; (b) [***], (c)
in the case of Jazz, (i) Jazz shall [***], and (d) in the case of ImmunoGen,
ImmunoGen shall [***].

2.2.      Retained Rights. Subject to the other terms of this Agreement
(including Section 2.3), ImmunoGen retains the right to use the Licensed
Technology and Licensed Patent Rights (a) to perform its obligations under this
Agreement; and (b) to develop, make, have made, use, sell, offer for sale,
import or otherwise commercialize [***], and to grant licenses to Third Parties
to do the same. Jazz retains the rights to use the Jazz Intellectual Property
for all purposes and to grant licenses to Third Parties to do the same.

2.3.      Covenants.

2.3.1.      Covenants. Anything contained in Section 2.2 to the contrary
notwithstanding, [***] hereby agrees that, on a country-by-country basis during
the Royalty Term, it and its Affiliates shall not (a) directly or indirectly
through a Third Party, [***]; provided that the foregoing shall not restrict the
ability of [***].

2.3.2.      Exceptions. Notwithstanding the foregoing, the restrictions of
Section 2.3.1 shall not apply [***].

2.4.      No Implied Licenses. Except as specifically set forth herein, neither
Party grants to the other Party or its Affiliates any rights or licenses to any
intellectual or other proprietary property owned or Controlled by that Party.

3.         GOVERNANCE

3.1.      Alliance Management.

3.1.1.      Appointment of Alliance Managers. Promptly after the Effective Date,
the Parties shall each appoint an individual who shall oversee contact between
the Parties for all matters related to this Agreement and the Parties’
respective activities hereunder (the “Alliance Managers”). The Alliance Managers
may not be members of the JSC or the JDC and will not have any voting rights
thereon, but the Alliance Managers may attend all meetings of the JSC and the
JDC and may bring to the attention of the JSC and the JDC any matters or issues
either of them

-31-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

reasonably believes should be discussed by the JSC or the JDC. Each Party may
replace its Alliance Manager at any time by notice to the other Party.

3.1.2.      Responsibilities. The Alliance Managers shall have the
responsibility of creating and maintaining a constructive work environment
between the Parties for all matters related to this Agreement and the Parties’
respective activities hereunder. Without limiting the generality of the
foregoing, the Alliance Managers shall:

(a)        identify and bring to the attention of their respective managements
any disputes arising between the Parties related to this Agreement or the
Parties’ respective activities hereunder in a timely manner, including any
asserted occurrence of a material breach by a Party, and function as the point
of first referral in the resolution of each dispute;

(b)        provide a single, continuous point of communication between the
Parties with respect to this Agreement and the Parties’ respective activities
hereunder;

(c)        plan and coordinate efforts and external communications by or between
the Parties with respect to this Agreement and the Parties’ respective
activities hereunder;

(d)        take such steps as may be required to ensure that meetings of the JSC
and JDC occur as set forth in this Agreement, that procedures are followed with
respect to such meetings (including the giving of proper notice and the
preparation and approval of minutes) and that relevant action items resulting
from such meetings are appropriately carried out or otherwise addressed; and

(e)        undertake such other responsibilities as set forth in this Agreement
or as the Parties may mutually agree in writing.

3.2.      Joint Steering Committee.

3.2.1.      Mandate and Establishment of Committee. Promptly after the Effective
Date, the Parties shall establish a joint steering committee (the “JSC”) to
serve as a forum for the general oversight and coordination of the Parties’
activities under this Agreement. Within [***] days after the Effective Date, the
Parties shall each nominate up to three (3) representatives for

-32-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

membership on the JSC. Each Party may change its representatives as it deems
appropriate by written notice to the other Party; provided that neither Party
may have more than three (3) representatives and that each representative is an
officer or employee of the applicable Party or its Affiliate who has sufficient
experience and responsibility within such Party to make decisions arising within
the scope of the JSC’s responsibilities. From time to time, the JSC may
establish one or more sub-teams comprised of qualified representatives of both
Parties to undertake specific responsibilities of the JSC, which sub-teams shall
be governed in the same manner and subject to the relevant requirements set
forth herein for the JSC. If any sub-team fails to reach unanimous agreement on
a matter before it within [***] days, the sub-team will refer the matter to the
JSC.

3.2.2.      Co-Chairs of Committee. Each Party shall nominate a co-chair of the
JSC. The co-chairpersons are responsible on an alternating basis for preparing
reasonably detailed written minutes of JSC meetings that reflect all material
decisions made at such meetings. The applicable co-chairperson will prepare
minutes of each JSC meeting and will send draft minutes to each representative
of the JSC for review and approval within [***] Business Days after the JSC
meeting. Such minutes shall be deemed approved unless one or more JSC
representatives object to the accuracy of such minutes within [***] Business
Days after receipt. The co-chairpersons shall have no additional powers or
rights beyond those held by other JSC representatives.

3.2.3.      Meetings. The JSC shall meet on [***] basis or other schedule agreed
upon by the Parties, unless the Parties mutually agree in advance of any
scheduled meeting that there is no need for such meeting. In such instance, the
next JSC meeting shall also be scheduled as agreed upon by the Parties. In
addition, either Party may call for a JSC meeting at any time by providing at
least [***] days’ notice to the other Party. The location of meetings of the JSC
shall alternate between ImmunoGen’s offices and Jazz’s offices, unless otherwise
agreed by the Parties. As agreed upon by the Parties, JSC meetings may be
face-to-face or may be conducted through teleconferences or videoconferences. In
addition to its JSC representatives, each Party may have other employees,
agents, or consultants attend such meetings to observe, present, and participate
in discussion, but such attendees will not have any decision-making capacity.
Each Party shall bear

-33-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

its own costs and expenses, including travel and lodging expense, that may be
incurred by JSC representatives or other attendees at JSC meetings, as a result
of such meetings hereunder.

3.2.4.      Decision Making. All decisions of the JSC will be made by consensus,
with each Party having collectively one (1) vote. If the JSC is unable to reach
unanimous agreement on any matter within [***] days following the date such
matter was first put to a vote, then the JSC will refer such matter to the
Senior Officers for resolution by good faith negotiations commencing promptly
after such notice is received. If the Senior Officers are not able to resolve
such matter within [***] days following delivery of the notice referring the
matter to the Parties’ respective Senior Officers, then [***]; provided that
[***] may [***] pursuant to this Section 3.2.4: (a) in a manner that excuses
Jazz from any of its obligations specifically enumerated in this Agreement, (b)
in a manner that [***], (c) to [***], (d) to [***], (e) to make [***] that
[***], or (f) in a manner that [***].

3.2.5.      Responsibilities. The JSC shall be responsible for the following:

(a)        establishing and overseeing joint sub-teams to oversee particular
projects or activities within the purview of the JSC;

(b)        serving, in accordance with [***], as a forum [***] under this
Agreement [***] regarding the Development of the Licensed Product or [***]
regarding [***]; and

(c)        undertaking such other responsibilities as set forth in this
Agreement or as the Parties may mutually agree in writing.

3.3.      Joint Development Committee.

3.3.1.      Mandate and Establishment of Committee. Promptly after the Effective
Date, the Parties shall establish a joint development committee (the “JDC”) to
serve as a forum for coordination and communication between the Parties with
respect to the Parties’ conduct of the Development of the Licensed Product
pursuant to the Development Plan, including the CMC aspects of the Development
Plan. Within [***] days after the Effective Date, the Parties shall each

-34-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

nominate between two (2) and five (5) (inclusive) representatives for membership
on the JDC. Each Party may change its representatives as it deems appropriate by
written notice to the other Party; provided that neither Party may have fewer
than two (2) or more than five (5) representatives and that each representative
is an officer or employee of the applicable Party or its Affiliate who has
sufficient experience and responsibility within such Party to make decisions
arising within the scope of the JDC’s responsibilities. From time to time, the
JDC may establish one or more sub-teams comprised of qualified representatives
of both Parties to undertake specific responsibilities of the JDC, which
sub-teams shall be governed in the same manner and subject to the relevant
requirements set forth herein for the JDC. If any sub-team fails to reach
unanimous agreement on a matter before it within [***] days, the sub-team will
refer the matter to the JDC.

3.3.2.      Co-Chairs of the JDC. Each Party shall nominate a co-chair of the
JDC. The co-chairpersons are responsible on an alternating basis for preparing
reasonably detailed written minutes of JDC meetings that reflect all material
decisions made at such meetings. The applicable co-chairperson will prepare
minutes of each JDC meeting and will send draft minutes to each representative
of the JDC for review and approval within [***] Business Days after the JDC
meeting. Such minutes shall be deemed approved unless one or more JDC
representatives object to the accuracy of such minutes within [***] Business
Days after receipt. The co-chairpersons shall have no additional powers or
rights beyond those held by other JDC representatives.

3.3.3.      Meetings. The JDC shall meet on a quarterly basis or other schedule
agreed upon by the Parties, unless the Parties mutually agree in advance of any
scheduled meeting that there is no need for such meeting. In such instance, the
next JDC meeting shall also be scheduled as agreed upon by the Parties. In
addition, either Party may call for a JDC meeting at any time by providing at
least [***] days’ notice to the other Party. The location of meetings of the JDC
shall alternate between ImmunoGen’s offices and Jazz’s offices, unless otherwise
agreed by the Parties. As agreed upon by the Parties, JDC meetings may be
face-to-face or may be conducted through teleconferences or videoconferences. In
addition to its JDC representatives, each Party may have other employees,
agents, or consultants attend such meetings to observe, present, and participate
in discussion, but such attendees will not have any decision-making

-35-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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capacity. Each Party shall bear its own costs and expenses, including travel and
lodging expense, that may be incurred by JDC representatives or other attendees
at JDC meetings, as a result of such meetings hereunder.

3.3.4.      Decision Making. All decisions of the JDC will be made by consensus,
with each Party having collectively one (1) vote. If the JDC is unable to reach
unanimous agreement on any matter within its authority within [***] days
following the date such matter was first put to a vote, then the JDC shall refer
the matter to [***] for resolution in accordance with [***].

3.3.5.      Responsibilities. The JDC shall be responsible for the following:

(a)        coordinating the activities of the Parties under and overseeing
Development of the Licensed Product pursuant to the Development Plan;

(b)        reviewing and discussing, as necessary, the performance of each
Party, or a Party’s Affiliate or Sublicensee, as applicable, in performing the
activities under the Development Plan;

(c)        reviewing and approving any material amendments to the Development
Plan on an annual basis so that the Development Plan covers at all times not
less than a two (2) year period, on a rolling basis, from the date of any such
update and evaluating any substantive departures from the Development Plan;

(d)        establishing and overseeing joint sub-teams to oversee particular
projects or activities within the purview of the JDC; and

(e)        undertaking such other responsibilities as set forth in this
Agreement or as the Parties may mutually agree in writing.

3.4.      Joint Intellectual Property Committee. Promptly after the Effective
Date, the Parties shall establish a joint intellectual property committee
(“JIPC”) to serve as a forum for providing periodic updates to the Parties with
respect to developments related to the Licensed Patent Rights and Patent Rights
disclosing Joint Product Technology and for coordinating the

-36-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Parties respective obligations to each other pursuant to Section 9. The JIPC
shall be comprised of at least one (1) representative of each Party. Each Party
may change its representative(s) as it deems appropriate by written notice to
the other Party; provided that each representative is an officer or employee of
the applicable Party or its Affiliate who has sufficient experience and
responsibility within such Party to make decisions arising within the scope of
the JIPC’s responsibilities. As agreed upon by the Parties, meetings of the JIPC
may be face-to-face or may be conducted by teleconferences or videoconferences,
from time to time as reasonably requested by either Party, but no less
frequently than [***], unless otherwise agreed to by the Parties.

3.5.      One Committee. Notwithstanding the provisions of this Article 3, the
JSC and the JDC shall consist of the same representatives, respectively, as the
JSC and JRDC established under the Collaboration and Option Agreement for so
long as both this Agreement and the Collaboration and Option Agreement are in
full force and effect at the same time, all meetings of the JSC under this
Agreement and the JSC under the Collaboration and Option Agreement shall be
scheduled at the same time and locations, and all meetings of the JDC under this
Agreement and the JRDC under the Collaboration and Option Agreement shall be
scheduled at the same time and locations.

4.         DEVELOPMENT AND COMMERCIALIZATION

4.1.      Development and Commercialization.

4.1.1.      Development Responsibility and Authority. From and after the
Effective Date, except as otherwise set forth in the Development Plan, and
subject to Sections 3.3 and 3.4, Jazz shall have sole authority and
responsibility (notwithstanding the formation of the JDC or its decisions) for
the Development, manufacture, use and Commercialization of the Licensed Product
in the Territory, including: (a) the conduct of all research and pre-clinical
Development activities (including all pre-clinical and IND-enabling studies
(including toxicology testing), any pharmaceutical development work on
formulations and process development relating to the Licensed Product); (b) all
activities related to human clinical trials; (c) all activities relating to the
manufacture and supply (including process development and scale up work) of the
Licensed Product, including manufacture and supply of Antibodies, Cytotoxic
Compounds and Linkers with respect thereto; and (d) all Commercialization
activities relating to the Licensed Product

-37-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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(including marketing, promotion, sales, distribution, import and export
activities and any post-marketing trials and safety surveillance). Without
limiting the generality of the foregoing, as between the Parties, Jazz shall
have full control and authority and sole responsibility for (i) making all
Regulatory Filings for the Licensed Product and filing all Drug Approval
Applications and otherwise seeking all Regulatory Approvals regarding such
matters and (ii) the reporting of all adverse events for the Licensed Product to
Regulatory Authorities if and to the extent required by Applicable Laws. All
Development activities with respect to the Licensed Product shall be conducted
pursuant to the Development Plan then in effect.

4.1.2.      Diligence. Jazz shall use [***] to Develop the Licensed Product and
to seek appropriate Regulatory Approvals necessary to market the Licensed
Product in the Jazz Territory and, following receipt of all such necessary
Regulatory Approvals in a particular country in the Jazz Territory, to
Commercialize the Licensed Product in such country. ImmunoGen shall use [***] to
perform, in accordance with the Development Plan, all Development activities
allocated to it pursuant to the Development Plan. In determining whether Jazz is
using [***] to Develop the Licensed Product, the Parties shall consider, among
other things, [***]. [***] means that Jazz or any of its Affiliates,
Sublicensees, or Permitted Third Party Service Providers are [***].

4.1.3.      Compliance. Each Party shall perform its obligations, if any, to
Develop the Licensed Product in good scientific manner and in compliance in all
material respects with all Applicable Laws, and, without limiting the foregoing,
with respect to each activity so performed that will or would reasonably be
expected to be submitted to a Regulatory Authority in support of a Regulatory
Filing, each Party comply in all material respects with the regulations and
guidance of the FDA that constitute GLP, GCP, or GMP. Jazz shall perform its
obligations to Commercialize the Licensed Product in compliance in all material
respects with all Applicable Laws.

4.1.4.      Regulatory Interactions. Jazz shall have regulatory responsibility
for the Licensed Product, including conducting all meetings with Regulatory
Authorities, and Jazz shall own and hold all Regulatory Filings for the Licensed
Product. During the Term, (a) Jazz shall [***]. Jazz shall [***] to such
material Regulatory Filings and correspondence with Regulatory Authorities or
their agents in good faith, provided [***] within [***] Business Days (or
shorter if

-38-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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required by the applicable Regulatory Authority) of receipt, except for [***]
for which [***] will have [***] Business Days to [***] (subject to extension
[***]).

4.1.5.      Governmental Inspections. If either Party or its Affiliates,
Sublicensees or Permitted Third Party Service Providers (each such Party, an
“Inspected Party”) are to be inspected by a government authority regarding the
Development, manufacture, or Regulatory Approval of the Licensed Product, the
Inspected Party shall promptly notify the other Party of the inspection in
writing as soon as reasonably practicable, and in advance, if any such
inspection is a scheduled inspection. The Inspected Party shall, where
practicable, [***]. The Parties shall cooperate in good faith and otherwise
mutually support any regulatory inspections of facilities, clinical sites,
contract manufacturers or the like with respect to the Licensed Product,
including by using reasonable efforts to make available such facilities,
documents, information and/or personnel as are reasonably necessary or useful
for such regulatory inspections by a government authority.

4.2.      Safety; Adverse Event Reporting. Promptly following the Effective
Date, the Parties, through the JDC, shall negotiate, in good faith, the terms of
a separate, related safety data exchange agreement providing details related to
managing adverse events that occur during clinical studies, safety issues
arising from pre-clinical research and other safety and reporting practices and
procedures in compliance with all Applicable Laws.

4.3.      Updates and Reports; Notification of Milestones; Product Recalls.

4.3.1.      Development Updates. Each Party shall keep the JDC reasonably
informed on the Development activities, if any, performed by such Party under
this Agreement,. Without limiting the foregoing, at each regularly scheduled JDC
meeting, each Party shall provide the JDC with a summary report of the
Development activities performed by it since the last JDC meeting and the
results thereof. The JDC shall discuss the progress and results of the Parties’
Development activities and each Party shall promptly respond to the other
Party’s reasonable questions or requests for additional information relating to
such Development activities.

4.3.2.      Commercialization Updates. Upon the request of ImmunoGen, Jazz shall
provide ImmunoGen with brief written reports, which ImmunoGen may request no
more frequently than [***] per Calendar Year, that summarize Jazz’s efforts to
Commercialize the

-39-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

Licensed Product in the Jazz Territory in sufficient detail to establish that
Jazz is [***] to Commercialize the Licensed Product in the Jazz Territory.

4.3.3.      Notification of Milestone Achievement. Jazz shall notify ImmunoGen
promptly in writing of the occurrence of any event giving rise to an obligation
to make a milestone payment to ImmunoGen under Section 6.3, which shall in any
event be no later than [***] Business Days after the occurrence of such event,
and shall notify ImmunoGen promptly in writing upon the occurrence of [***]. In
the event that, notwithstanding the fact that Jazz has not given any such
notice, ImmunoGen believes in good faith that any such milestone event has
occurred, it shall so notify Jazz in writing, and shall provide to Jazz the data
and information demonstrating that the conditions for payment have been
achieved.

4.3.4.      Product Recalls. In the event any Regulatory Authority issues or
requests a recall or takes similar action with respect to the Licensed Product,
or in the event either Party reasonably believes that an event, incident or
circumstance has occurred that may result in the need for such a recall, the
Party first becoming aware of such Regulatory Authority issuance or request or
having such reasonable belief shall promptly notify the other Party thereof by
telephone or email. Following such notification, Jazz shall decide and have
control of whether to conduct a recall or market withdrawal (except in the event
of a recall or market withdrawal mandated by a Regulatory Authority, in which
case it shall be required) or take such other corrective action in any country,
and of the manner in which any such recall, market withdrawal or corrective
action shall be conducted, provided that Jazz shall keep ImmunoGen informed
regarding any such recall, market withdrawal or corrective action as ImmunoGen
from time to time may reasonably request, but only to the extent Jazz is legally
permitted to do so. Jazz shall bear all expenses of any such recall, market
withdrawal or corrective action in the Jazz Territory, including expenses of
notification, destruction and return of the Licensed Product and any refund to
customers of the amounts paid for the Licensed Product; provided,  however,
notwithstanding the foregoing that [***].

4.3.5.      Confidential Information. All reports, updates, product complaints
and other information provided by the Disclosing Party to the Receiving Party
under this Agreement

-40-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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(including under this Section 4.3), is the Confidential Information of the
Disclosing Party, subject to the terms of Section 8.

4.4.      Use of ImmunoGen Proprietary Materials. If ImmunoGen supplies its
Proprietary Materials to Jazz for use in the Development and Commercialization
of the Licensed Product, Jazz agrees that (a) it shall not use such Proprietary
Materials for any purpose other than exercising its rights and performing its
obligations hereunder; (b) it shall not use such Proprietary Materials in any
human subject; (c) it shall use such Proprietary Materials in compliance with
Applicable Laws; (d) except for the rights expressly set forth herein, it shall
not acquire any other right, title or interest in or to such Proprietary
Materials as a result of such supply by ImmunoGen; and (e) upon termination of
this Agreement for any reason, Jazz shall, if and as instructed by ImmunoGen,
either destroy or return such Proprietary Materials that are not the subject of
a continuing license hereunder. Jazz may transfer such Proprietary Materials to
any Affiliate, Sublicensee or Permitted Third Party Service Provider under terms
obligating such Affiliate, Sublicensee or Permitted Third Party Service Provider
not to use or transfer such Proprietary Materials except in compliance with the
preceding sentence.

4.5.      Unauthorized Use of ImmunoGen’s Proprietary Materials and Confidential
Information. If Jazz or any of its Affiliates (a) use ImmunoGen’s Proprietary
Materials for any purpose other than in connection with Jazz’s exercise of its
rights and performance of its obligations hereunder or (b) use any ImmunoGen
Confidential Information (including any ImmunoGen Confidential Information
within the Licensed Technology) [***] for any purpose that is not in connection
with Jazz’s exercise of its rights and performance of its obligations hereunder
(each of (a) and (b), an “Unauthorized Use”), the results of any such
Unauthorized Use, and any results, discoveries or inventions that arise from
such Unauthorized Use, whether or not patentable, shall belong solely and
exclusively to ImmunoGen. If required in order to perfect or enforce ImmunoGen’s
rights to such results, discoveries and inventions, Jazz, on behalf of itself
and its Affiliates, agrees to assign, and hereby does assign, to ImmunoGen all
of its and their right, title and interest in and to all such results,
discoveries and inventions (including all Patent Rights thereto). Jazz agrees to
cause each Sublicensee or Permitted Third Party Service Provider to assign to
ImmunoGen all of such Sublicensee’s or Permitted Third Party Service Provider’s
interest in

-41-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

and to any results, discoveries and inventions, whether or not patentable,
arising from such Sublicensee’s or Permitted Third Party Service Provider’s
Unauthorized Use of ImmunoGen’s Proprietary Materials or ImmunoGen Confidential
Information (including any ImmunoGen Confidential Information within the
Licensed Technology). Jazz agrees that it will, and it will cause its
Affiliates, Sublicensees and Permitted Third Party Service Providers to,
cooperate with ImmunoGen, and to execute and deliver any and all documents that
ImmunoGen deems reasonably necessary or desirable, to perfect and enforce its
rights hereunder.

4.6.      Development Transition and Regulatory Transfer. The Parties shall
endeavor to agree upon a plan, based on the proposed clinical and regulatory
transfer plan provided to Jazz under the Collaboration and Option Agreement and
taking Jazz’s comments on such proposed plan into account, to effect a smooth
and orderly transfer of the following, to the extent not previously provided to
Jazz or its designee (such plan, once agreed upon by the Parties, the “Clinical
and Regulatory Transfer Plan”).

4.6.1.      Regulatory Approvals. ImmunoGen shall provide Jazz with complete and
accurate copies of (and if reasonably requested by Jazz, physical access to the
originals of) all filings, correspondence and meeting minutes from meetings,
teleconferences and videoconferences with Regulatory Authorities regarding the
Licensed Product. ImmunoGen shall, and hereby does, transfer to Jazz all of
ImmunoGen’s right, title, and interest in and to all Regulatory Filings and
Regulatory Approvals that are necessary or reasonably useful for Jazz to Develop
and Commercialize the Licensed Product (excluding any Regulatory Filings or
Regulatory Approvals required for the general operation of ImmunoGen’s
facilities). To the extent that ImmunoGen is unable under Applicable Law to
transfer any Regulatory Approvals to Jazz pursuant to this Section 4.6.1
ImmunoGen shall, and hereby does, effective as of the Effective Date, grant Jazz
a non-exclusive, royalty-free right of reference under the applicable Regulatory
Filings that are necessary or useful to Develop or Commercialize the Licensed
Product solely to Develop and Commercialize the Licensed Product.

4.6.2.      Clinical Trials. ImmunoGen shall cooperate with Jazz to effect a
smooth and orderly transfer to Jazz or its designee of all clinical trials of
the Licensed Product that are ongoing as of the Effective Date, which transfer
will be performed in accordance with a mutually

-42-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

agreed transition plan and in a manner designed to minimize any disruption or
delay caused by such transfer. At Jazz’s request, ImmunoGen shall transfer the
clinical databases and global safety database for the Licensed Product to Jazz
or its designee and take other actions reasonably requested by Jazz to enable it
to assume the regulatory reporting and other responsibilities associated with
being the sponsor of such ongoing clinical trials. In accordance with the
Clinical and Regulatory Transfer Plan,  ImmunoGen shall provide Jazz with
complete and accurate copies of (and if reasonably requested by Jazz, physical
access to the originals of) all data in ImmunoGen’s Control from clinical trials
or preclinical testing of the Licensed Product, to the extent that such data was
not provided pursuant to the Collaboration and Option Agreement.

4.6.3.      Third Party Agreements. At Jazz’s request, ImmunoGen shall assign to
Jazz or its designee those of ImmunoGen’s and its Affiliate’s agreements with
Third Parties pertaining to the Development of the Licensed Product (including
such agreements with contract research organizations, clinical sites, and
investigators) that are identified in Jazz’s request, except to the extent that
ImmunoGen is not able, despite the use of [***], to obtain consent for such
assignment [***]. For a period of [***] months after the Effective Date (except
for with respect to [***] for which there will be no time limitation), ImmunoGen
shall provide Jazz with the benefit of any agreements with Third Parties
pertaining to the Development that are not assigned to Jazz or its designee
pursuant to the preceding sentence to the extent requested by Jazz and Jazz
shall have the benefit of any such agreement solely for Jazz to Develop the
Licensed Product.

4.6.4.      Support. For a reasonable time (not to exceed [***] months) after
the Effective Date, as reasonably requested by Jazz, ImmunoGen shall make its or
its Affiliates’ employees and consultants available to Jazz the extent
reasonably necessary or useful: (a) for Jazz to conduct activities of similar
nature to the activities conducted by ImmunoGen prior to the Effective Date with
respect to the Development of the Licensed Product, including oversight of any
ongoing clinical trials and continuation of the investigator-initiated studies,
(b) to conduct activities reasonably necessary to transfer to Jazz all data in
the clinical databases and the global safety database, (c) to conduct activities
reasonably necessary to transfer to Jazz the INDs, orphan drug applications and
designations, and other Regulatory Filings and Regulatory Approvals, and (d) to
conduct all other activities that are reasonably necessary to enable Jazz to

-43-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

assume responsibility for all Development and Commercialization of the Licensed
Product, including conduct of on-going clinical trials, receipt, processing, and
reporting of SAEs, and creation of periodic regulatory reports (such as a DSUR
and IND annual reports). If Jazz requests that, in lieu of transitioning to Jazz
or its designee certain Development activities that ImmunoGen was conducting
immediately prior to the Effective Date, ImmunoGen continue or complete such
activities during such [***]-month period, then Jazz shall reimburse ImmunoGen
for Jazz’s share of the costs reasonably incurred by ImmunoGen to continue or
complete such activities (as if such costs were Development Costs).

5.         SUPPLY AND MANUFACTURING OBLIGATIONS; SERVICES

5.1.      Manufacturing Responsibilities. Jazz shall be responsible for
manufacturing or having manufactured, all materials (including all Antibody,
Linker, and Cytotoxic Compound) to enable it to Develop, manufacture, use and
Commercialize the Licensed Product.

5.2.      Technology Transfers. The Parties shall, within [***] days of the
Effective Date, agree in accordance with this Section 5.2 on a plan to perform
(either directly or via the applicable ImmunoGen contract manufacturing
organization) technology transfers to Jazz, its Affiliate, or Permitted Third
Party Service Provider (the “Technology Transfer Plan”), for the purpose of
enabling Jazz to exercise its rights under this Agreement with respect to
manufacture of the Licensed Product, including the manufacture of each of [***],
each of which shall be the subject of a separate technology transfer if
requested by Jazz. ImmunoGen shall prepare a draft Technology Transfer Plan and
provide it to Jazz for Jazz’s review and comments. ImmunoGen shall incorporate
Jazz’s reasonable comments into the draft Technology Transfer Plan to generate
the final Technology Transfer Plan. As part of such Technology Transfer Plan,
the Parties shall agree on terms relating to (a) provision of the applicable
Technical Transfer Materials to Jazz, its Affiliate, or its Permitted Third
Party Service Provider, (b) provision of reasonable and customary on-site
support at the facilities of Jazz or its Affiliate or Permitted Third Party
Service Provider, as applicable, (c) participation in technical exchange
meetings, (d) review of draft batch records, (e) provision of reasonable
assistance to facilitate Jazz’s entry into a direct agreement with one or more
contract manufacturing organizations, and (f) provision of technical supervision
during the manufacture and release of any batches necessary to demonstrate that
the technology transfer is

-44-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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complete; provided, that, such technical support for each such technology
transfer shall not require more than [***] hours of ImmunoGen’s personnel and
shall not be required to be provided after the [***] month anniversary of the
Effective Date. Each Party shall perform the activities allocated to it under
the Technology Transfer Plan in accordance with the timelines set forth therein,
provided that the Parties shall adjust such timelines in the Technology Transfer
Plan as reasonably necessary due to technical issues. All costs of the foregoing
technology transfer activities shall be [***], provided that if Jazz enters into
an agreement with a contract manufacturing organization to transfer a validated
process, Jazz shall be responsible for [***] of the costs in connection with
validation campaigns undertaken by such contract manufacturing organization and,
to the extent material produced in such campaigns is used for clinical
development, the unit production costs of such materials will be [***].

5.3.      Interim Supply; CMO Agreements. Pursuant to the Technology Transfer
Plan, ImmunoGen will provide reasonable assistance to facilitate Jazz’s entry
into a direct agreement with one or more of the contract manufacturing
organizations from which ImmunoGen obtained, pursuant to the Collaboration and
Option Agreement, Licensed Product-related manufacturing services including
conjugation services and supply of [***]. Until the earlier of the [***]
anniversary of the Effective Date and the date that Jazz enters into such a
direct agreement with the applicable contract manufacturing organization, at
Jazz’s request, ImmunoGen shall supply Jazz with the [***]. ImmunoGen shall not
be liable under the supply agreement described below for any damages or loss
caused by any action or omission of [***] provided that ImmunoGen reasonably
exercises (in a manner that is consistent the actions that ImmunoGen would
otherwise take [***]) its rights and remedies (including indemnification rights)
under [***]. At either Party’s request, the Parties shall negotiate in good
faith a supply agreement on customary terms consistent with those set forth in
this Section 5.3, pursuant to which ImmunoGen would[***].

-45-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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6.         FINANCIAL TERMS

6.1.      Upfront Payment. Jazz shall pay an upfront payment equal to [$XX]5 to
ImmunoGen within [***] days after the Effective Date of this Agreement, which
upfront payment shall be non-refundable and non-creditable.

6.2.      Development Costs.6

6.2.1.      Development Costs. The Parties shall each bear fifty percent (50%)
of all Development Costs for initial and subsequent indications; provided,
 however, that Jazz shall bear all Development Costs incurred with respect to
activities that are not part of a global clinical trial and that are conducted
primarily for the purpose of obtaining or maintaining Regulatory Approval for
the Licensed Product within the Jazz Territory other than the United States or
the EU. For clarity, the purpose of the Development activities, rather than the
location where such activities are conducted, shall determine whether the
associated Development Costs will be shared equally by the Parties or borne by
Jazz. Each Party shall provide the other with a non-binding estimate of its
Development Costs incurred or to be incurred by such Party for each Calendar
Quarter at least [***] days before the end of such Calendar Quarter. No later
than [***] days after the end of each Calendar Quarter, each Party shall provide
to the other Party a reasonably detailed report showing all Development Costs
incurred by such Party during the previous Calendar Quarter subject to the
limitation set forth in the last sentence in this Section 6.2.1 (each such
report, a “Development Costs Report”). Within [***] days after the date that
both Parties have received a Development Costs Report with respect to a
particular Calendar Quarter, the Party that has paid more than fifty percent
(50%) of the aggregate Development Costs incurred by both Parties for the
applicable Calendar Quarter shall provide the other Party with an invoice for an
amount equal to fifty percent (50%) of the difference between the Development
Costs incurred by such Party for such Calendar Quarter and the Development Costs
incurred by the other Party for such Calendar Quarter, and such other Party
shall pay such invoice within [***] days of receipt, using the wire transfer
provisions of Section 6.6.4. Notwithstanding the foregoing, in no event shall a
Party be required

 

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5 Include applicable amount of Jazz Option Exercise Fee under the Collaboration
and Option Agreement.

6 [***]

-46-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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to reimburse the other Party for Development Costs incurred by such other Party
in any Calendar Quarter in excess of [***] of the amount set forth in the
Development Plan Budget for such Calendar Quarter for the activities for which
the other Party is responsible under the Development Plan, as the Development
Plan and Development Plan Budget may be amended from time to time. If a Party
anticipates incurring costs in excess of [***] of the amount set forth in the
Development Plan Budget for activities for which such Party is responsible under
the Development Plan, (i) such Party shall notify the other Party and may
request an increase the Development Plan Budget to cover such excess costs, (ii)
the other Party shall consider such request in good faith and shall not deny
such request to the extent that such excess costs are due to unforeseeable
events outside of the reasonable control of such Party, and (iii) such Party
shall continue to be responsible for the performance of such activities under
the Development Plan and, unless the Parties mutually agree to an amendment to
the Development Plan and Development Plan Budget, such Party shall be
responsible for [***] of such excess costs.

6.2.2.      [***].

(a)        In the event that Jazz desires to (i) undertake Development
activities (other than post-marketing requirements or commitments imposed by a
Regulatory Authority) that are [***] in connection with the Development of the
Licensed Product related to seeking or maintaining Regulatory Approval in the
United States or the EU and [***] for such activities would [***], or (ii) make
Material Base Budget Increases that [***] and are [***], Jazz may so notify the
JDC of such proposed Development activities and Material Base Budget Increases,
as applicable, in reasonable detail and provide a good faith estimate of the
budget for such Development activities and material increases (such activities
and material increases, the “Additional Development Activities”, and such budget
estimate, the “Additional Development Activities Budget”) at least [***] days
prior to the meeting of the JDC at which such matter is to be considered.

(b)        If ImmunoGen [***] to have such Additional Development Activities and
Additional Development Activities Budget included in the Development Plan and
Development Plan Budget, then the Development Plan and Development Plan Budget
shall [***]. Notwithstanding the foregoing, Jazz may conduct the Additional
Development Activities [***]

-47-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

and shall provide updates on the conduct and results of such Additional
Development Activities at each subsequent meeting of the JDC during the conduct
of such Additional Development Activities.

(c)        Upon completion of such Additional Development Activities, Jazz shall
present a final report of the results of such Additional Development Activities
to the JDC. If such Additional Development Activities are Successful (as defined
below), then [***]. Additional Development Activities are “Successful” (1) with
respect to [Additional Development Activities directed to any [***]]7, if such
activities [***], in the case of a clinical trial, or otherwise [***] of such
Additional Development Activities that are [***], and (2) with respect to
Additional Development Activities directed to [***], if such activities [***].

(d)        [***]

6.2.3.      Burdened Technology for Licensed Products. ImmunoGen shall provide
Jazz with an unredacted copy of each agreement entered into by ImmunoGen with
Third Parties [***] under which ImmunoGen obtains rights to Burdened Technology
(a “Burdened Technology Agreement”). Jazz may elect in writing to exclude such
Technology and Patent Rights under such Burdened Technology Agreement from the
Licensed Intellectual Property that would otherwise be sublicensed to Jazz under
this Agreement (but for clarity, if ImmunoGen has a joint ownership interest in
and to any such Technology or Patent Rights, then such Technology and Patent
Rights shall remain included in the Licensed Intellectual Property with respect
to ImmunoGen’s ownership therein) and upon any such election Jazz shall have no
responsibility for any payments owed to such Third Party with respect to such
Technology or Patent Rights. If Jazz does not elect to exclude such Technology
and Patent Rights under any such agreement, then Jazz will be deemed to have
agreed to comply with the terms of any such agreement applicable to Jazz as a
sublicensee thereunder. Unless Jazz has elected to exclude Burdened Technology
from the Licensed Intellectual Property, Jazz shall [***] ImmunoGen for [***] by
ImmunoGen to Third Parties under a Burdened Technology Agreement (i) that are
incurred in connection with the Development of a Licensed Product and become due
because of an event pertaining specifically

 

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

7 [***]

-48-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

to the Development of the Licensed Product under the Development Plan or
pursuant to Section 6.2.2, in each case for the sole purpose of seeking,
obtaining or maintaining Regulatory Approval outside of the United States or the
EU, or (ii) that are incurred in connection with the Commercialization of the
Licensed Product ((i) and (ii) collectively, the “Burdened Technology
Payments”). ImmunoGen shall [***] of the Burdened Technology Payments made by
ImmunoGen to Third Parties under a Burdened Technology Agreement as set forth in
this Section 6.2.3, and Jazz shall pay such invoice within [***] days of
receipt, using the wire transfer provisions of Section 6.6.4. Notwithstanding
the foregoing, ImmunoGen shall be responsible for [***] of (1) all costs payable
to one or more Third Parties, if any, pursuant to [***]any [***] agreements
entered into by ImmunoGen [***] in consideration for use of the Burdened
Technology, including in each case [***] and (2) any [***]; provided that, (A)
[***], and (B) if such [***] grants rights to any intellectual property [***] or
for any purpose other than [***] for establishment of [***], then ImmunoGen
shall [***] with respect to the establishment of [***]. ImmunoGen shall not
terminate or materially breach its obligations pursuant to, or materially amend
in a manner that adversely affects Jazz’s rights under, the agreements [***].

6.2.4.      Categorization of Payments. Except with respect to any payments owed
pursuant to an agreement entered into by either Party with Third Parties [***],
or any Burdened Technology Agreement excluded from the Licensed Intellectual
Property by Jazz pursuant to Section 6.2.3, to determine whether a particular
payment by a Party to a Third Party in consideration for the acquisition,
license, or use of any rights to any Technology or Patent Rights is (i) a
Development Out-of-Pocket Cost under Section 6.2.1, (ii) a Burdened Technology
Payment under Section 6.2.3 [***], or (iii) a payment for which Jazz is able to
take a deduction under Section 6.4.2(a), the following shall apply:

(a)        For payments that specifically relate to Development activities for
the purpose of seeking, obtaining or maintaining Regulatory Approval in the
United States or the EU (e.g., a milestone that is payable upon the filing of a
BLA in the United States), such payments shall be considered to be in connection
with the Development of the Licensed Product and are Development Out-of-Pocket
Costs;

-49-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

(b)        For payments that specifically relate to Development activities for
the sole purpose of seeking, obtaining or maintaining Regulatory Approval
outside of the United States or the EU (e.g., a milestone that is payable upon
the filing of a BLA in Japan), such payments shall be considered to be in
connection with the Development of the Licensed Product and are not Development
Out-of-Pocket Costs, but rather are Burdened Technology Payments (for which Jazz
is able to take a deduction under Section 6.4.2(b)) if ImmunoGen entered into
such Third Party agreement or are payments for which Jazz is able to take a
deduction under Section 6.4.2(a) if Jazz entered into such Third Party
agreement;

(c)        For payments that specifically relate to Commercialization activities
(e.g., royalty and sales milestones), such payments shall be considered to be in
connection with the Commercialization of the Licensed Product and are Burdened
Technology Payments (for which Jazz is able to take a deduction under
Section 6.4.2(b)) if ImmunoGen entered into such Third Party agreement or are
payments for which Jazz is able to take a deduction under Section 6.4.2(a) if
Jazz entered into such Third Party agreement; and

(d)        For all other payments that are not specific to Development
activities or Commercialization activities (e.g., upfront payments), such
payments shall be considered to be (1) in connection with the Development of the
Licensed Product and Development Out-of-Pocket Costs if the related agreement
under which the rights were acquired was entered into by either Party [***], or
(2) in connection with the Commercialization of the Licensed Product and
Burdened Technology Payments (for which Jazz is able to take a deduction under
Section 6.4.2(b)) if ImmunoGen entered into such Third Party agreement or are
payments for which Jazz is able to take a deduction under Section 6.4.2(a) if
Jazz entered into such Third Party agreement, in each case if the related
agreement under which the rights were acquired was entered into by the
applicable Party [***].

6.3.      Milestone Payments for Licensed Product. In consideration of the grant
by ImmunoGen of the license described in Section 2.1.1 and subject to the other
terms and conditions of this Agreement (including Section 12 of Exhibit A), Jazz
shall make the following payments in U.S. Dollars to ImmunoGen in accordance
with Section 6.6.4 within thirty (30) days after achievement of each of the
following milestone events:

-50-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

 

 

(a) [***]

[***]

(b) [***]

[***]

 

It is hereby acknowledged and agreed that any milestone payment shall be made
only once, with respect to the first achievement of the relevant milestone,
regardless of how many times such milestone is achieved. In no event will Jazz
be required to pay more than a total of $100.0 million pursuant to this Section
6.3. All milestone payments shall be non-refundable and non-creditable. Jazz
shall notify ImmunoGen of the achievement of each milestone hereunder as
provided in Section 4.3.3.

6.4.      Payment of Royalties; Royalty Rates; Accounting for Royalties and
Records.

6.4.1.      Royalty Payments. Commencing on the first date of First Commercial
Sale of the Licensed Product in any country or jurisdiction in the Jazz
Territory, Jazz shall pay to ImmunoGen the following royalties, as calculated by
multiplying the applicable royalty rates below by the corresponding amount of
incremental Net Sales in the Jazz Territory of all Licensed Product sold by
Jazz, its Affiliates and its Sublicensees during the Royalty Term:

 

 

For Calendar Year Net Sales of Licensed Product in the Jazz Territory during the
Royalty Term

Royalty Rate8

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

6.4.2.      Third Party Royalty Offset. Subject to Section 6.4.7, if, with
respect to a Calendar Quarter, Jazz or any of its Affiliates or Sublicensees
[***] (a) [***] to one or more Third Parties [***] any rights to any
intellectual property that are [***] the Licensed Product in any country, and
(b) any Burdened Technology Payments ((a) and (b) collectively, “Third Party
Payments”), then Jazz shall have the right to reduce the royalties otherwise due
to ImmunoGen pursuant to Section 6.4.1 with respect to Net Sales in such country
of the Licensed Product in such

 

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

8 Insert lower number in each row if Jazz has exercised the Jazz Early Stage
Option, and the higher number in each row if Jazz has exercised the Jazz Late
Stage Option.

-51-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

Calendar Quarter by an amount equal to [***] of the amount of such Third Party
Payments; provided,  however, if Jazz or any of its Affiliates or Sublicensees
obtains rights to any intellectual property subject to this Section 6.4.2 that
is [***], then (i) with respect to any Third Party Payment that became due
because of an event pertaining [***] to [***], Jazz may reduce the royalties
pursuant to this Section 6.4.2 by [***] of such Third Party Payment, (ii) with
respect to any Third Party Payment that became due because of an event
pertaining [***] to [***], Jazz shall [***], and (iii) with respect to any other
Third Party Payment, then the amount by which Jazz may reduce the royalties
pursuant to this Section 6.4.2 on account of such Third Party Payment shall be
[***] (e.g., if the intellectual property [***], then Jazz may deduct [***] of
such Third Party Payment). For the avoidance of doubt, this Section 6.4.2 shall
not apply to (a) the portion of royalties owed by Jazz under Section 6.4.6 or
(b) any Third Party Payments payable by Jazz or any of its Affiliates or
Sublicensees under any license or other agreement, written or oral, between Jazz
or any of its Affiliates or Sublicensees, on the one hand, and any Third Party,
on the other hand, in existence as of the Effective Date. Notwithstanding the
foregoing, those amounts paid to Third Parties that have been included in the
calculation of Development Out-of-Pocket Costs (and therefore shared by the
Parties pursuant to Section 6.2.1) shall not also be used pursuant to this
Section 6.4.2 to reduce the royalties paid by Jazz under this Agreement.

6.4.3.      Valid Claim Coverage. Subject to Section 6.4.7, on a
country-by-country basis, if the Licensed Product is not Covered by a Valid
Claim within the Licensed Patent Rights at the time that Net Sales occur in such
country, the royalties payable with respect to Net Sales of the Licensed Product
sold by Jazz, its Affiliates and its Sublicensees in such country shall be
reduced by [***] of the royalties otherwise owed to ImmunoGen pursuant to
Section 6.4.1. Such reduction shall be calculated using a methodology similar to
that outlined in Exhibit C (Royalty Rate Reduction Methodology). The Parties
hereby acknowledge and agree that such royalties shall be in consideration of
the commercial advantage, know-how and background information gained from the
unpatented Licensed Technology.

6.4.4.      Applicability of Royalty Rates. For purposes of clarity, (i) if the
Licensed Product is Covered by a Valid Claim in a country within the Jazz
Territory such that royalties are payable by Jazz pursuant to Section 6.4.1, and
6.4.6, as applicable, and, prior to the expiration of

-52-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

the Royalty Term for the Licensed Product in such country, the Licensed Product
is no longer Covered by a Valid Claim in such country or there is Generic
Competition in such country, Jazz shall pay ImmunoGen a royalty at the rate set
forth in Section 6.4.3 or 6.4.4, as applicable, for the remainder of the Royalty
Term in such country; and (ii) if the Licensed Product is not Covered by a Valid
Claim in a country within the Territory such that royalties are paid by Jazz
pursuant to Section 6.4.3 and, prior to the expiration of the Royalty Term for
the Licensed Product in such country, the Licensed Product becomes Covered by a
Valid Claim within the Licensed Patent Rights in such country, then Jazz shall
pay ImmunoGen a royalty at the rates set forth in Section 6.4.1, and 6.4.6, as
applicable, for that portion of the Royalty Term during which such Valid Claim
Covers the Licensed Product in such country unless there is Generic Competition
in such country, in which case Jazz’s royalty obligation shall be as set forth
in Section 6.4.4 for the remainder of the Royalty Term.

6.4.5.      Generic Competition. Subject to Section 6.4.7, if Generic
Competition exists with respect to the Licensed Product in a country in the Jazz
Territory in a Calendar Quarter during the Royalty Term, then the royalties
payable with respect to Net Sales of the Licensed Product sold by Jazz, its
Affiliates, and its Sublicensees in such country for such Calendar Quarter shall
be reduced by [***] of the royalties otherwise owed to ImmunoGen pursuant to
Section 6.4.1 or 6.4.6, as applicable. Such reduction shall be calculated using
a methodology similar to [***].

6.4.6.      Effect of Challenge. Except to the extent the following is
unenforceable under Applicable Laws, if Jazz or its Affiliates initiates a
Challenge or induces or assists a Third Party in initiating or prosecuting a
Challenge (the Licensed Patent Rights subject to such Challenge being referred
to herein as the “Challenged Patent Rights”), then during the period that such
Challenge is pending, [***] in the country(ies) in which the Challenge is
pending (each, a “Challenge Jurisdiction”) commencing on the date of such
Challenge initiation or the date Jazz or its Affiliates first induces or
provides assistance to such Third Party, as applicable, but only with respect to
Net Sales in the applicable Challenge Jurisdiction(s). If, following the final,
unappealable conclusion of a Challenge in a Challenge Jurisdiction, there
remains one or more Valid Claims within the Challenged Patent Rights that would
be infringed by the manufacture, use, sale, offer for sale or importation of the
Licensed Product by Jazz or any of its Affiliates or

-53-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

Sublicensees in the applicable Challenge Jurisdiction, then (a) the [***] shall
remain in effect for the remainder of the Royalty Term with respect to Net Sales
of the Licensed Product in the applicable Challenge Jurisdiction, and (b) Jazz
shall reimburse ImmunoGen for its costs and expenses (including reasonable
attorneys’ and experts’ fees and expenses of litigation) incurred in responding
to the Challenge. Jazz shall pay such reimbursement within [***] days of
receiving an invoice therefor from ImmunoGen, which shall set forth in
reasonable detail the basis for the charges for which ImmunoGen is seeking
reimbursement. If, following the final, unappealable conclusion of a Challenge
in a Challenge Jurisdiction, there remain no Valid Claims within the Challenged
Patent Rights that would be infringed by the manufacture, use, sale, offer for
sale or importation of the Licensed Product by Jazz or any of its Affiliates or
Sublicensees in such Challenge Jurisdiction in the absence of the license
granted under Section 2.1.1, then ImmunoGen shall [***] with respect to the
[***] with respect to the Challenge Jurisdiction (the “[***]”) as follows: (i)
Jazz may [***] of each royalty payment due under this Section 6.4 as they become
due from and after the final, unappealable conclusion of such Challenge in such
Challenge Jurisdiction [***] until [***]; and (ii) ImmunoGen shall pay to Jazz
any [***] of the [***] within thirty (30) days after receipt by ImmunoGen of an
invoice from Jazz therefor.

6.4.7.      Minimum Royalty Rate. Anything contained in this Agreement to the
contrary notwithstanding, none of the reductions to royalties provided in
Sections 6.4.3 and 6.4.4, shall, individually or in the aggregate, [***] the
royalties payable with respect to Net Sales of the Licensed Product sold by
Jazz, its Affiliates and its Sublicensees in any country during the Royalty Term
by more than [***] of the royalties otherwise owed to ImmunoGen pursuant to
Section 6.4.1 or 6.4.6, whichever is applicable, without giving effect to any
royalty reduction provided in Section 6.4.3 or 6.4.4.

6.5.      Royalty Term. Jazz shall pay royalties with respect to the Licensed
Product on a country-by-country basis commencing upon the First Commercial Sale
of the Licensed Product in such country and ending on the later of (a) [***]
years from the date of First Commercial Sale of the Licensed Product in such
country and (b) the expiration of the last to expire Valid Claim within the
Licensed Patent Rights that Covers the Licensed Product in such country (the
“Royalty Term”). For the purposes of determining whether a Valid Claim Covers
the Licensed Product

-54-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

under this Section 6.5, any Valid Claim within the Licensed Patent Rights that
is jointly owned by Jazz (or any of its Affiliates) with ImmunoGen (or any of
its Affiliates) shall be deemed to be solely owned by ImmunoGen or an Affiliate
of ImmunoGen.

6.6.      Payment Terms.

6.6.1.      Payment of Milestones; Payment of Royalties; Royalty Reports. Jazz
shall make any milestone payments owed to ImmunoGen hereunder in U.S. Dollars,
using the wire transfer provisions of Section 6.6.4 within [***] days of the
occurrence of the applicable event giving rise to the obligation and receipt by
Jazz of an invoice from ImmunoGen to make such payment. Jazz shall make any
royalty payments owed to ImmunoGen in U.S. Dollars, quarterly within [***] days
following the end of each Calendar Quarter for which such royalties are deemed
to occur (as provided in the next sentence), using the wire transfer provisions
of Section 6.6.4. Determination of when a sale of the Licensed Product occurs
for purposes of this Agreement shall be made when the revenue from such sale is
recognized by Jazz in accordance with Jazz Accounting Standards or, in the case
of Sublicensees, in accordance with such Sublicensees’ respective revenue
recognition accounting standards, consistently applied. Each royalty payment
shall be accompanied by a report for each country in the Jazz Territory in which
sales of the Licensed Product occurred in the Calendar Quarter covered by such
statement, specifying each of: (a) the gross sales (if available) and the Net
Sales in each country’s currency of the Licensed Product in the Jazz Territory
during the reporting period by Jazz and its Affiliates and Sublicensees
(specifying in reasonable detail each of the deductions to gross sales used to
calculate Net Sales); (b) the applicable exchange rate to convert each country’s
currency to U.S. Dollars under Section 6.6.2; (c) the applicable royalty rate(s)
under this Agreement (specifying in reasonable detail each adjustment, if any,
to the royalty rate(s) as provided in Sections 6.6.2–6.7, inclusive); and (d)
the royalties payable, in U.S. Dollars, which shall have accrued hereunder with
respect to such Net Sales. Jazz shall provide ImmunoGen with a non-binding
estimate of its royalty payments owed

-55-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

to ImmunoGen for each Calendar Quarter at least [***] days before the end of
such Calendar Quarter.

6.6.2.      Accounting. All payments hereunder shall be made in U.S. Dollars.
Royalties shall be calculated based on Net Sales in U.S. Dollars, with the
conversion of Net Sales in each country to U.S. Dollars according the Jazz
Standard Exchange Rate Methodology.

6.6.3.      No Set-Off; Tax Withholding. All payments made by Jazz to ImmunoGen
hereunder shall be made without set-off or counterclaim and free and clear of
any taxes, duties, levies, fees or charges, except for withholding taxes, if
any. Jazz shall make any applicable withholding payments due on behalf of
ImmunoGen and shall provide ImmunoGen with reasonable proof of payment of such
withholding taxes, together with an accounting of the calculations of such
taxes, within [***] days after such payment is remitted to the proper authority.
Any withheld tax remitted by Jazz to the proper authority shall be treated as
having been paid by Jazz to ImmunoGen for all purposes of this Agreement. The
Parties shall cooperate reasonably in completing and filing documents required
under the provisions of any Applicable Laws in connection with the making of any
required withholding tax payment, or in connection with any claim to a refund of
or credit for any such payment.

6.6.4.      Wire Transfers. All payments by either Party hereunder shall be made
in U.S. Dollars by bank wire transfer in immediately available funds to the
account designated the receiving Party by written notice to paying Party from
time to time.

6.7.      Overdue Payments. Subject to the other terms of this Agreement, any
payments hereunder not paid within the applicable time period set forth herein
shall bear interest from the due date until paid in full, at a rate per annum
equal to the lesser of (a) [***], or (b) the maximum interest rate permitted by
Applicable Law in regard to such payments, calculated in each case from the date
such payment was due through to the date on which payment is actually made;
provided,  however, that with respect to any disputed payments, no interest
payment is due until such dispute is resolved and the interest payable thereon
will be based on the finally resolved amount of such payment, calculated from
the original date on which the disputed payment was due through the date on
which payment is actually made. Such interest and the payment and acceptance
thereof

-56-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

shall not negate or waive the right of a Party to any other remedy, legal or
equitable, to which it may be entitled because of the delinquency of the
payment.

6.8.      Records Retention; Audit.

6.8.1.      Record Retention. Each Party and its Affiliates and Sublicensees
shall keep for at least [***] years from the end of the Calendar Year to which
they pertain complete and accurate records of Net Sales and Development Costs
incurred by such Party or its Affiliates or Sublicensees, in sufficient detail
to allow the accuracy of the royalty payments and other payments and reports to
be confirmed.

6.8.2.      Audit. Subject to the other terms of this Section 6.8.2, at the
request of a Party (the “Inspecting Party”), upon at least [***] Business Days’
prior written notice, but no more often than [***] and not more frequently than
[***] with respect to records covering any specific period of time, and at the
Inspecting Party’s sole expense (except as otherwise provided herein), the other
Party (the “Audited Party”) shall permit an internationally recognized
independent accounting firm [***] to inspect (during regular business hours) at
such place or places where such records are customarily kept the relevant
records required to be maintained by the Audited Party and its Affiliates and
Sublicensees under Section 6.8.1. At the Inspecting Party’s request, the
independent accounting firm may audit the then-preceding [***] years of the
Audited Party’s records solely for purposes of verifying the items set forth in
Section 6.8.1. Before beginning the audit the independent accounting firm shall
enter into a confidentiality agreement with both Parties substantially similar
to the provisions of Section 8 limiting the disclosure and use of such
information by such independent accounting firm to authorized representatives of
the Parties and the purposes germane to this Section 6.8.2. The independent
accounting firm shall provide its audit report and basis for any determination
to the Audited Party at the time such report is provided to the Inspecting
Party. Each Party shall each have the right to request a further determination
by such independent accounting firm as to matters which such Party disputes
within [***] days following receipt of such report. The Party initiating a
dispute will provide the other Party and the independent accounting firm with a
reasonably detailed statement of the grounds upon which it disputes any findings
in the audit report and the independent accounting firm shall undertake to
complete such further determination within [***] days after the dispute notice
is

-57-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

provided, which determination shall be limited to the disputed matters and
provided to both Parties. The Parties shall use reasonable efforts, through the
participation of finance representatives of both Parties, to resolve any dispute
arising in relation to the audit by good faith discussion. The results of any
such audit, reflecting the independent accounting firm’s determination of any
disputed matters, shall be binding on both Parties, absent manifest error. The
Inspecting Party agrees to treat the results of any such independent accounting
firm’s review of the Audited Party’s records under this Section 6.8.2 as
Confidential Information of the Audited Party subject to the terms of Section 8.
If any such audit reveals an inaccuracy in the calculation of royalties or other
amounts resulting in any underpayment by the Audited Party, the Audited Party
shall pay the Inspecting Party the amount remaining to be paid (plus interest
thereon at a rate provided in Section 6.7) on or before the date the next
quarterly royalty payment or other Development Cost reimbursement payment would
otherwise be due (or, if the Audited Party is notified of such inaccuracy after
the expiration of the Royalty Term or any such payment obligation, within [***]
days from the date of the Audited Party’s receipt of written notification of
such inaccuracy), and if such underpayment is by [***] or more of the total
amounts due over the audited period, the Audited Party shall pay the Inspecting
Party’s reasonable costs and expenses of conducting the audit. If any audit
reveals an inaccuracy in the calculation of royalties or other Development Cost
reimbursement payment resulting in an overpayment by the Audited Party, the
Audited Party may invoice the Inspecting Party for such overpayment, and the
Inspecting Party shall pay such invoice within [***] days from the date of its
receipt of such invoice.

6.9.      Financial Statements.

6.9.1.      If Jazz determines that it or its Affiliates require financial
information regarding the Licensed Product to support its or its Affiliates’
accounting treatment for the transactions contemplated by this Agreement in
accordance with United States Generally Accepted Accounting Principles (“US
GAAP”) or to meet any regulatory requirements to present financial statements
related to the Licensed Product, (a) Jazz shall notify ImmunoGen of that
determination and (b) ImmunoGen shall promptly provide to Jazz and/or its
Affiliates statements of (i) assets acquired or licensed and liabilities assumed
and (ii) direct operating expenses relating to the Licensed Product, in each
case for the periods that are required (collectively, “Abbreviated

-58-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Financial Statements”). In addition, ImmunoGen acknowledges that Jazz and/or its
Affiliates may be required to include “carve out” financial statements and/or
other financial information relating to the Licensed Product for one or more
years or interim periods and pro forma financial information (collectively, and
together with the Abbreviated Financial Statements, the “Financial Statements”)
in documents that may be filed with the SEC by Jazz and/or its Affiliates
pursuant to the Securities Act of 1933, as amended (the “Securities Act”), and
that such Financial Statements may be required to be audited in accordance with
US GAAP and requirements of the Public Company Accounting Oversight Board Rules
and may need to comply with the requirements of one or more registration
statements, reports or other documents (collectively, the “SEC Documents”) under
the Securities Act, the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), and the rules set forth in Regulation S-X thereunder. From and
after the Effective Date, ImmunoGen shall (and shall cause its accountants,
counsel, agents and other Third Parties) assist Jazz and/or its Affiliates in
preparing and obtaining the Financial Statements. Jazz shall be responsible for,
and obligated to reimburse ImmunoGen for, all reasonable Third Party costs
(including all costs of its auditors) and expenses incurred by ImmunoGen
associated with obtaining the Financial Statements. ImmunoGen shall provide Jazz
and/or its Affiliates reasonable access during normal business hours to such
work papers, records and personnel of ImmunoGen and its Affiliates and their
respective accounting firms as Jazz and/or its Affiliates may reasonably request
to enable Jazz and/or its Affiliates, and their respective representatives and
accountants, to create and audit the Financial Statements, as the case may be.
ImmunoGen shall obtain representation letters and similar documents from
applicable personnel of ImmunoGen and its Affiliates as may be required in
connection with the preparation and audit of the Financial Statements.

6.9.2.      ImmunoGen hereby consents to the inclusion or incorporation by
reference of the Financial Statements in any SEC Document of Jazz or any of its
Affiliates to be filed with the SEC. Upon request of Jazz, ImmunoGen agrees to
request the external audit firm that audits the Financial Statements to consent
to the inclusion or incorporation by reference of its audit opinion with respect
to the audited Financial Statements in any such SEC Document. ImmunoGen shall
(i) provide Jazz and/or its Affiliates, successors or assignees and their
respective independent accountants with access to management representation
letters provided by

-59-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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ImmunoGen to the extent related to the Financial Statements and (ii) authorize
the external audit firm that audits the Financial Statements to provide its
audit work papers to the extent related to the Financial Statements to Jazz
and/or its Affiliates and their respective independent accountants.

7.         CO-DEVELOPMENT OPT-IN RIGHT

7.1.      ImmunoGen Opt-In Right. If ImmunoGen has not previously exercised the
ImmunoGen Opt-In Right under any Exclusive License Agreement, Jazz shall, and
shall cause its Affiliates and Sublicensees to, provide written notice to
ImmunoGen within [***] Business Days of [***] for the Licensed Product, which
notice shall also include (i) if Jazz [***], access for ImmunoGen to the [***]
for such [***] and (ii) an ImmunoGen Opt-In Data Package. ImmunoGen shall then
have the option, exercisable in its sole discretion, to designate the Licensed
Product as the Co-Development Product. ImmunoGen may exercise the ImmunoGen
Opt-In Right with respect to the Licensed Product by providing written notice to
Jazz at any time following the Effective Date until [***] Business Days
following receipt of [***], provided that ImmunoGen has not yet exercised the
ImmunoGen Opt-In Right under any Exclusive License Agreement[***] Upon exercise
of the ImmunoGen Opt-In Right hereunder, the terms of Exhibit A attached hereto
shall be effective.

8.         TREATMENT OF CONFIDENTIAL INFORMATION

8.1.      Confidentiality.

8.1.1.      Confidentiality Obligations. ImmunoGen and Jazz each recognizes that
the other Party’s Confidential Information constitutes highly valuable assets of
such other Party. ImmunoGen and Jazz each agrees that, subject to Section 8.1.2,
during the Term and for an additional [***] years thereafter, (a) it shall not
disclose, and it shall cause its Affiliates and contractually obligate its
Permitted Third Party Service Providers (and in the case of Jazz, it shall also
contractually obligate its Sublicensees) not to disclose, any Confidential
Information of the other Party and (b) it shall not use, and it shall cause its
Affiliates and contractually obligate its Permitted Third Party Service
Providers (and, in the case of Jazz, it shall also contractually obligate its
Sublicensees) not to use, any Confidential Information of the other Party, in
either case, except as expressly permitted hereunder. Without limiting the
generality of the foregoing, each Party shall

-60-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

take such action, and shall cause its Affiliates and contractually obligate its
Permitted Third Party Service Providers (and, in the case of Jazz, it shall also
contractually obligate its Sublicensees) to take such action, to preserve the
confidentiality of the other Party’s Confidential Information as such Party
would customarily take to preserve the confidentiality of its own Confidential
Information and shall, in any event, use at least reasonable care to preserve
the confidentiality of the other Party’s Confidential Information. In addition,
ImmunoGen shall, and shall cause its Affiliates to, use adequate and diligent
efforts, consistent with ImmunoGen’s past practices but no less than a
reasonable degree of care, to preserve and protect the confidential nature of
the Licensed Intellectual Property that is not specific to the Licensed Product.

8.1.2.      Limited Disclosure. Each Receiving Party may disclose the Disclosing
Party’s Confidential Information to its Affiliates and Permitted Third Party
Service Providers (and, in the case of Jazz, its Sublicensees) and their
respective Representatives to enable the Receiving Party to exercise its rights
or to carry out its responsibilities under this Agreement, provided that such
disclosure shall only be made to Persons who are bound by written obligations at
least as stringent as those described in Section 8.1.3. In addition, the
Receiving Party may disclose the Disclosing Party’s Confidential Information to
the extent such disclosure (a) is reasonably necessary to file, prosecute or
maintain patents or patent applications in accordance with the Receiving Party’s
rights under Section 9.2, or to file, prosecute or defend litigation related to
such patents or patent applications, subject to the restriction set forth in
Section 9.2.6, and otherwise in accordance with this Agreement, or (b) is
required by Applicable Laws, provided that in the case of any disclosure under
clause (b), the Receiving Party shall (i) if practicable, provide the Disclosing
Party with reasonable advance notice of and an opportunity to comment on any
such required disclosure, (ii) if requested by the Disclosing Party, cooperate
in all reasonable respects with the Disclosing Party’s efforts to obtain
confidential treatment or a protective order with respect to any such
disclosure, at the Disclosing Party’s expense, and (iii) use good faith efforts
to incorporate the comments of the Disclosing Party in any such disclosure or
request for confidential treatment or a protective order.

8.1.3.      Employees, Consultants and Subcontractors. ImmunoGen and Jazz each
hereby represents and warrants that all of its and its Affiliates’
Representatives who participate in

-61-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

the activities contemplated by this Agreement or who otherwise have access to
Confidential Information of the other Party are or will, prior to their
participation or access, be bound by written obligations to maintain such
Confidential Information in confidence and not to use such information except as
expressly permitted hereunder. Each Party agrees to use, and to cause its
Affiliates (and, in the case of Jazz, its Sublicensees and Permitted Third Party
Service Providers) to use, reasonable efforts to enforce such obligations.

8.2.      Publicity.

8.2.1.      Terms of Agreement. The Parties acknowledge that the terms of this
Agreement constitute the Confidential Information of each Party and may not be
disclosed except as permitted by Section 8.1 and this Section 8.2. Either Party
may disclose the terms of this Agreement (a) on a need-to-know basis to such
Party’s legal, accounting and financial advisors and (b) as reasonably necessary
in connection with any actual or potential (i) debt or equity or other financing
of such Party or (ii) purchase by any Third Party of all the outstanding capital
stock or all or substantially all of the assets of such Party or any merger or
consolidation involving such Party; and provided further that in each case the
Person to whom the terms of this Agreement is to be disclosed agrees in writing
to maintain the confidentiality of such information with terms at least as
protective as those contained in Section 8.1 or in the case of Third Party
potential investors, acquirors, lenders or bankers or their representatives, who
are bound by written confidentiality obligations consistent with industry
standards.

8.2.2.      Public Announcements. Anything contained in this Agreement to the
contrary notwithstanding, upon the execution of this Agreement the Parties shall
negotiate in good faith for a mutually agreed joint press release with respect
to this Agreement and shall issue such joint press release within [***] Business
Days following the Signing Date. After issuance of such press release, neither
Party shall publish, present or otherwise disclose publicly any material related
to events arising under this Agreement without the prior written consent of the
other Party, which consent shall not be unreasonably withheld, conditioned or
delayed; provided that notwithstanding the foregoing, (A) neither Party will be
prevented from complying with any duty of disclosure it may have pursuant to
Applicable Laws; (B) either Party shall be permitted to publish such material in
accordance with Section 8.3; (C) ImmunoGen shall be permitted to

-62-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

publicly announce the occurrence of any milestone event under Section 6.3 and
the amount payable to ImmunoGen in connection therewith, and (D) subject to
Section 8.3, Jazz may publish, present or otherwise disclose publicly any
materials related to events arising under this Agreement without ImmunoGen’s
prior written consent provided that Jazz provides ImmunoGen with a draft of the
relevant publication, presentation or disclosure for its review and comment at
least three (3) Business Days prior to publication and removes any Confidential
Information of ImmunoGen as requested by ImmunoGen. Either Party may make
subsequent and repeated public disclosure of the contents of any disclosures
made or permitted by this Section 8.2.2 without the prior written consent of the
other Party.

8.2.3.      Legal Disclosures. Notwithstanding the terms of this Article 8,
either Party may disclose the existence and terms of this Agreement to the
extent required, in the reasonable opinion of such Party’s legal counsel, to
comply with Applicable Laws, including the rules and regulations promulgated by
the United States Securities and Exchange Commission (“SEC”) or any other
Governmental Authority. Notwithstanding the foregoing, before disclosing this
Agreement or any of the terms hereof pursuant to this Section 8.2.3, the Parties
will coordinate in advance with each other in connection with the redaction of
certain provisions of this Agreement with respect to any filings with the SEC,
the NASDAQ Stock Market or any other stock exchange on which securities issued
by a Party or a Party’s Affiliate are traded, and each Party shall use
commercially reasonable efforts to seek confidential treatment for such terms as
may be reasonably requested by the other Party; provided that each Party will
ultimately retain control over what information that Party discloses to their
relevant exchange; and provided further that the Parties shall use commercially
reasonable efforts to file redacted versions with any governing bodies that are
consistent with redacted versions previously filed with any other governing
bodies. Other than the foregoing obligation, neither Party (nor its Affiliates)
will be obligated to consult with or obtain approval from the other Party with
respect to any filings to the SEC, the NASDAQ Stock Market or any other stock
exchange.

8.3.      Publications and Presentations. Jazz may publish or present, or permit
to be published or presented, the design or results of the Development,
manufacture, use and Commercialization of the Licensed Product or Co-Development
Product, if applicable (the

-63-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

“Covered Results”). ImmunoGen agrees that, except as required by Applicable
Laws, it shall not publish or present, or permit to be published or presented,
the Covered Results without the prior review by and approval of Jazz, which
approval shall not be unreasonably withheld, conditioned or delayed; provided,
that it shall be deemed reasonable for Jazz to withhold its consent to any
request by ImmunoGen to publish or present any Covered Results prior to the
planned publication or dissemination of such Covered Results by Jazz. Each Party
shall provide to the other Party the opportunity to review each of the
submitting Party’s proposed (a) abstracts and manuscripts for scientific
journals or conferences that relate to the Covered Results at least [***] days
prior to intended submission for publication, and (b) presentations at
scientific conferences (including information to be presented verbally) that
relate to the Covered Results at least [***] Business Days prior to its intended
presentation. Upon written request from a Party given within such applicable
review period, the other Party shall (i) not submit such abstract or manuscript
for publication or make such presentation until appropriate patent applications
are filed to protect any unpatented Technology disclosed in such publication or
presentation that such Party reasonably believes may be patentable and (ii)
remove any Confidential Information of such Party that is disclosed in any such
proposed publication or presentation prior to such publication or presentation.
Once such abstracts, manuscripts or presentations (or the information contained
therein) have been reviewed and, if applicable, modified for publication or
presentation pursuant to this Section 8.3, the same abstracts, manuscripts or
presentations (and the information contained therein) do not have to be provided
again by one Party to the other Party for review for a later submission for
publication. In any permitted publication or presentation by a Party, the other
Party’s contribution shall be duly recognized, and co-authorship shall be
determined in accordance with customary industry standards.

8.4.      Integration. Any confidential information of a Party disclosed under
that certain Confidential Disclosure Agreement effective [***] by and between
ImmunoGen and Jazz or the Collaboration and Option Agreement relating to the
subject matter of this Agreement shall be treated as Confidential Information of
such Party hereunder, subject to the terms of this Section 8, and to the extent
that the terms and conditions of such earlier agreements are not consistent with
this Section 8, the terms and conditions of this Section 8 shall take precedence
with respect to matters pertaining to this Agreement.

-64-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

9.         FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS

9.1.      Ownership of Intellectual Property; Disclosure. Except as set forth in
Section 9.1.3 or otherwise expressly provided herein, all inventions and
discoveries invented, conceived, or developed by or on behalf of a Party or its
Affiliates, whether alone or with the other Party or a Third Party, in
conducting activities pursuant to this Agreement and any Patent Rights claiming
the foregoing shall be owned based on inventorship, as inventorship is
determined in accordance with United States patent law, irrespective of where or
when such conception, discovery or development occurs. For the avoidance of
doubt, “activities pursuant to this Agreement” includes participation in
committee meetings and any other communications between the Parties in
connection with this Agreement.

9.1.1.      ImmunoGen Solely Owned Intellectual Property. Anything contained in
this Agreement to the contrary notwithstanding, as between the Parties,
ImmunoGen shall be the sole owner of, and subject to the license granted in
Section 2.1.1, shall retain all right, title and interest in and to the Licensed
Intellectual Property (other than Joint Product Technology and any Joint Product
Patents).

9.1.2.      Jazz Intellectual Property. Anything contained in this Agreement to
the contrary notwithstanding, as between the Parties, Jazz shall be the sole
owner of, and subject to the license granted in Section 2.1.2, shall retain all
right, title and interest in and to the Jazz Intellectual Property.

9.1.3.      Assignment of ADC Platform Improvements. Any ADC Platform
Improvements that are invented, conceived, or developed by or on behalf of Jazz
or its Affiliates or Sublicensees, whether alone or with ImmunoGen or a Third
Party, in conducting activities pursuant to this Agreement, and any Patent
Rights claiming any such ADC Platform Improvements, shall be owned by and
assigned to ImmunoGen. Jazz shall, and does hereby, assign, and shall cause its
Affiliates and Sublicensees to so assign, to ImmunoGen without additional
compensation, Jazz’s, or any Sublicensee of Jazz’s, entire right, title and
interest in and to such ADC Platform Improvements and any Patent Rights claiming
any such ADC Platform Improvement as is necessary to fully effectuate the sole
ownership provided in this Section 9.1.3.

-65-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

All such assigned ADC Platform Improvements and all Patent Rights claiming ADC
Platform Improvements shall be included in the Licensed Intellectual Property if
it is necessary or useful to Develop, make, have made, use, sell, offer for
sale, import, or otherwise Commercialize the Licensed Product.

9.1.4.      Ownership of Joint Product Technology. All Joint Product Technology
shall be jointly owned by ImmunoGen and Jazz, and the Parties shall also jointly
own Joint Product Patents, with each Party holding an undivided one-half
interest therein.

9.1.5.      Disclosure. On a semi-annual basis at a meeting of the JIPC, (a)
Jazz shall disclose to ImmunoGen the making, conception or reduction to practice
by or on behalf of Jazz of any Joint Product Technology and ADC Platform
Improvements, and (b) ImmunoGen shall disclose to Jazz the making, conception
and reduction to practice by or on behalf of ImmunoGen of any Joint Product
Technology and other Licensed Technology.

9.1.6.      Freedom to Operate. Subject to the exclusive licenses and rights set
forth in Section 2.1 and the payment obligations set forth in Article 6, the
corresponding provisions of any Exclusive License Agreement and the Jazz Options
pursuant to the Collaboration and Option Agreement, the Parties hereby agree
that either Party and its Affiliates shall be free to use and disclose all Joint
Product Technology for any and all uses, and to license Third Parties to do the
same on a worldwide basis, without obtaining the prior approval of the other
Party and without any duty to account or otherwise make any payment of
compensation to the other Party; provided, that (a) the Parties shall not
disclose any invention within the Joint Product Technology in a manner that
would prejudice either Party’s ability to patent such invention, and (b) each
Party’s use of Joint Product Technology shall be subject to the restrictions set
forth in Section 2.3.1 of this Agreement, the corresponding provisions of any
Exclusive License Agreement, and Section 5.3 of the Collaboration and Option
Agreement.

9.2.      Patent Filing, Prosecution and Maintenance.

9.2.1.      [***].  Promptly after the Effective Date, the Parties, acting
through the JIPC, shall discuss [***] on Licensed Patent Rights Controlled by
ImmunoGen as of the Effective Date to [***]. ImmunoGen, after giving due
consideration to such discussions, shall [***], which

-66-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

shall be deemed to be [***], provided that ImmunoGen shall be under no
obligation to take any action with respect to [***].

9.2.2.      With respect to new patent filings made during the Term, ImmunoGen
shall [***], provided that ImmunoGen shall be under no obligation to [***].

9.2.3.      Platform Patent Rights. [***], acting through patent counsel or
agents of its choice, shall have the initial right, but not the obligation, in
its sole discretion, to prepare, file, prosecute, and maintain (including
responding to inter partes reviews, post-grant reviews, and similar oppositions
in other jurisdictions) all Platform Patent Rights in the Core Patent Territory.
At [***] request and at its sole cost and expense, [***] shall prepare, file,
prosecute, and maintain Platform Patent Rights in countries specified by [***]
outside the Core Patent Territory. [***] in such Platform Patent Rights as a
result thereof. Upon [***] reasonable request (but no more than once in any
given twelve- (12-) month period), [***] shall provide [***] with a written
report summarizing the status of [***] and any material developments with
respect thereto during the previous [***] months, including any [***].

9.2.4.      Product Patent Rights. Promptly after the Effective Date, [***]
shall [***] and shall take all actions and execute all documents reasonably
necessary for [***] the prosecution, maintenance, and defense of the Product
Patent Rights. [***], acting through patent counsel or agents of its choice,
shall have the right, but not the obligation, in its sole discretion, to
prepare, file, prosecute, and maintain Product Patent Rights (including by
responding to any office action or filing other formal papers related to any
appeal, reissue, inter partes review, post-grant review, opposition or any other
patent office or court proceeding worldwide involving Product Patent Rights
covered by this section 9.2.4 (collectively, “Patent-Related Filings”)),
provided that [***] shall [***]. With respect to prosecution of Product Patent
Rights, [***] will provide [***] with a copy of any proposed Patent-Related
Filing for review and comment reasonably in advance of filing. [***] will [***]
that such filing [***]. [***] shall also provide [***] a reasonable time prior
to taking or failing to take any action that would affect the scope or validity
of any Product Patent Rights (including the substantial narrowing, cancellation
or abandonment of any claim(s) without retaining the right to pursue such
subject matter in a separate application, or the failure to file or perfect the
filing of any claim(s) in any country), with prior written notice of such
proposed

-67-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

action or inaction so that [***] has a reasonable opportunity to review and
comment and consider assuming responsibility for such Product Patent Rights
pursuant to Section 9.3.2 of this Agreement.

9.2.5.      Cooperation. Each Party agrees to cooperate reasonably with the
other Party in the preparation, filing, prosecution and maintenance of any
Licensed Patent Rights pursuant to this Section 9.2. Such cooperation includes
executing all papers and instruments, or requiring employees or others to
execute such papers or instruments, so as to effectuate the ownership of such
Licensed Patent Rights and to enable the filing, prosecution, maintenance, and
extension thereof in any country or region. In addition, the Parties shall
reasonably cooperate with each other in obtaining patent term restoration or
supplemental protection certificates or their equivalents in any country in the
Territory where applicable to the Licensed Patent Rights.

9.2.6.      Improper Patent Filings. Each Party agrees that, without the prior
written consent of the other Party, neither it nor any of its Affiliates will
claim in any patent application filed by or on behalf of such Party (or its
Affiliate) any unpatented, nonpublic invention for which the inventor(s) (alone
or with others) include employees of, or other persons obligated to assign
inventions to, the other Party or any Affiliate of the other Party, or disclose
any such invention in any such patent application in a manner that would
prejudice the other Party’s ability to patent such invention.

9.2.7.      Patent Prosecution Costs. Subject to Section 9.3, in addition to the
sharing of Development Costs to the extent required by this Agreement, the
Parties shall each bear fifty percent (50%) of all preparation, filing,
prosecution, and maintenance costs for the activities described in this Section
9.2, except that [***] shall bear all preparation, filing, prosecution, and
maintenance costs with respect to Platform Patent Rights in the Core Patent
Territory and [***] shall bear all preparation, filing, prosecution, and
maintenance costs with respect to Platform Patent Rights outside the Core Patent
Territory.

9.2.8.      Jazz Patents. As between the Parties, Jazz shall have the sole right
and option, but not the obligation, to prepare, file, prosecute, and maintain,
at its sole expense, any

-68-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

Patent Rights claiming any Jazz Intellectual Property or any Product Technology
solely owned by Jazz or its Affiliates.

9.3.      Abandonment.

9.3.1.      Platform Patent Rights

(a)        Within Core Patent Territory. If [***] decides to abandon or allow to
lapse, or otherwise determines to not prosecute or defend, any Platform Patent
Rights within the Core Patent Territory, ImmunoGen shall inform [***] of such
decision promptly and, in any event, so as to provide for a reasonable amount of
time to meet any applicable deadline to establish or preserve such Platform
Patent Rights in such country or region. If [***] does not have a bona fide
strategic reason for abandoning the prosecution, maintenance, or defense of any
Platform Patent Rights in any country or jurisdiction within the Core Patent
Territory, then [***] shall have the right to assume responsibility for
continuing the prosecution, maintenance, or defense of such Platform Patent in
such country or region and paying any required fees to maintain such Patent
Rights in such country or region or defending such Patent Rights, in each case
at [***] sole expense and through patent counsel or agents of its choice.
Otherwise, at [***] request, [***] shall continue the prosecution, maintenance,
and defense of such Platform Patent through patent counsel or agents of its
choice, all at [***] sole cost and expense. In either case, [***]. Upon transfer
of [***] responsibility for prosecuting, maintaining, and defending any of the
Platform Patent Rights under this Section 9.3.1(a), [***] shall promptly deliver
to [***] copies of all necessary files related to such Platform Patent Rights
with respect to which responsibility has been transferred and shall take all
actions and execute all documents reasonably necessary for [***] to assume such
prosecution, maintenance, and defense.

(b)        Outside Core Patent Territory. If [***] determines that it no longer
desires to pay for the prosecution or defense of any Platform Patent Rights in
one or more countries outside of the Core Patent Territory, then it may so
notify [***] and, thereafter, [***] may elect to continue the prosecution and
defense of such Platform Patent Rights in the country(ies) so specified by Jazz
in any such notice in ImmunoGen’s discretion at [***] sole expense and through
patent counsel or agents of its choice.

-69-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

9.3.2.      Product Patent Rights. If [***] decides to abandon or allow to
lapse, or otherwise determines to not prosecute or defend, any Product Patent
Rights, Jazz shall inform [***] of such decision promptly and, in any event, so
as to provide for a reasonable amount of time to meet any applicable deadline to
establish or preserve such Product Patent Rights in such country or region.
[***] shall have the right to assume responsibility for continuing the
prosecution, maintenance, or defense of such Product Patent Rights in such
country or region and paying any required fees to maintain such Product Patent
Rights in such country or region or defending such Product Patent Rights, in
each case at [***] sole expense and through patent counsel or agents of its
choice. [***] shall not become an assignee of [***] interest in such Product
Patent Rights claiming Joint Product Technology as a result of its assumption of
such responsibility. Upon transfer of [***] responsibility for prosecuting,
maintaining and defending any of the Product Patent Rights under this Section
9.3.2, [***] shall promptly deliver to [***] copies of all necessary files
related to such Product Patent Rights with respect to which responsibility has
been transferred and shall take all actions and execute all documents reasonably
necessary for [***] to assume such prosecution, maintenance and defense.

9.4.      Third Party Infringement.

9.4.1.      Notice of Infringement. If either Party becomes aware of any
possible infringement by, or submission by any Third Party of an application
under Section 351(k) of the PHSA with respect to, a product Targeting the
Licensed Target, the manufacture, use, offer for sale, sale or import of which
would, in the absence of a license from ImmunoGen, infringe any Licensed Patent
Rights (an “Infringement”), that Party shall promptly notify the other Party and
provide it with all details of such Infringement of which it is aware (each, an
“Infringement Notice”). If the Infringement involves such Third Party’s
application under Section 351(k) of the PHSA, Section 9.5 shall apply to such
Infringement to the extent that such Third Party complies with the provisions of
Section 351(I) of the PHSA referenced therein or contemplated thereby.

9.4.2.      Platform Patent Rights. [***] shall have the sole right to bring any
infringement action with respect to any alleged Infringement of the Platform
Patent Rights; provided, that notwithstanding the foregoing Jazz shall have the
first right to bring an infringement action with respect to any alleged
Infringement of any claim within the Platform Patent Rights that

-70-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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recites the specific Antibody component of the Licensed Product or any
cell-binding agent (including an Antibody) or conjugate of a cell-binding agent
with a Cytotoxic Compound (including an ADC) that Targets the Licensed Target.
[***] shall promptly notify [***] after bringing any such action and shall
provide [***] with quarterly updates regarding the status of such action. The
foregoing notwithstanding, [***] shall [***].

9.4.3.      Product Patent Rights. [***] shall have the first right and option,
but not the obligation, to eliminate such Infringement with respect to Product
Patent Rights by reasonable steps, which may include the institution of legal
proceedings or other action. All costs, including attorneys’ fees, relating to
such legal proceedings or other action shall be borne by [***]. If [***] does
not take commercially reasonable steps to eliminate the Infringement within
[***] days from any Infringement Notice, then [***] shall have the right and
option to do so at its expense, provided that if [***] has commenced
negotiations with an alleged infringer for elimination of such Infringement
within such [***]-day period, then [***] shall have an additional [***] days to
conclude its negotiations before [***] may take steps to eliminate such
Infringement.

9.4.4.      Consent to Settlement or Entry of Judgment. Jazz shall not consent
to the entry of judgment or enter into any settlement with respect to any
Infringement claim or proceeding under this Section 9.4 involving [***] without
the prior written consent of ImmunoGen, which consent shall not be unreasonably
withheld, conditioned or delayed. ImmunoGen shall not consent to the entry of
judgment or enter into any settlement with respect to any Infringement claim or
proceeding under this Section 9.4 involving [***] without the prior written
consent of Jazz, which consent shall not be unreasonably withheld, conditioned
or delayed.

9.4.5.      Participation. Each Party shall have the right to participate, and
be represented by counsel that it selects, at its own expense, in any legal
proceedings or other action instituted under this Section 9.4 by the other
Party, provided that [***] will have no such right with respect to [***]. If a
Party with the right to initiate legal proceedings under this Section 9.4 to
eliminate Infringement lacks standing to do so and the other Party has standing
to initiate such legal proceedings, such Party with standing shall initiate such
legal proceedings at the request and expense of the other Party.

-71-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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9.4.6.      Cooperation. In any action, suit or proceeding instituted under this
Section 9.4, the Parties shall cooperate with and assist each other in all
reasonable respects at the expense of the controlling Party. Upon the reasonable
request of the Party initiating such action, suit or proceeding, the other Party
shall join such action, suit or proceeding if necessary to establish standing
and shall be represented using counsel of its own choice, at the controlling
Party’s expense.

9.4.7.      Distribution of Monies. Unless otherwise mutually agreed by the
Parties, any damages, amounts received in settlement, judgment or other monetary
awards recovered by either Party pursuant to Section 9.4.2 or 9.4.3, whether by
settlement or judgment (“Monies”), shall be allocated in the following order:

First,

(a)        the Monies will be distributed first to the controlling Party for its
costs and expenses incurred under Section 9.4.2 or 9.4.3, as applicable; and

(b)        the Monies will then be distributed to the other Party for its costs
and expenses incurred under Section 9.4.3; and

(c)        the Monies remaining after (a) and (b) shall be deemed to be Net
Sales and (i) if Jazz is the controlling Party, then (1) Jazz shall pay to
ImmunoGen an amount equal to [***] of the royalty that would otherwise have been
owed by Jazz to ImmunoGen pursuant to Section 6.4 on account of such Net Sales
and (2) [***] or (ii) if ImmunoGen is the controlling Party, then (1) ImmunoGen
will retain an amount equal to [***] of royalty that would otherwise have been
owed by Jazz to ImmunoGen pursuant to Section 6.4 on account of such Net Sales
and (2) [***].

9.4.8.      Jazz Patents. As between the Parties, Jazz shall have the sole right
and option, but not the obligation, to eliminate any alleged infringement of any
Patent Rights claiming any Jazz Intellectual Property or any Product Technology
solely owned by Jazz or its Affiliates by reasonable steps, which may include
the institution of legal proceedings or other action as well as the settlement
thereof. Jazz may retain all damages, amounts received in connection therewith,

-72-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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including any settlement, judgment or other monetary awards recovered and shall
not have any obligation to make any payments to ImmunoGen with respect thereto.

9.5.      Response to Biosimilar Applicants.

9.5.1.      Notice. In the event that either Party (a) receives a copy of an
application submitted to the FDA under Section 351(k) of the PHSA (a “Biosimilar
Application”) for which the Licensed Product is a “reference product,” whether
or not such notice or copy is provided under any Applicable Laws (including
under the BPCIA, the United States Patient Protection and Affordable Care Act,
or implementing FDA regulations and guidance applicable to the approval or
manufacture of any “biosimilar or interchangeable biological product”) (a
“Proposed Biosimilar Product”), or (b) otherwise becomes aware that such a
Biosimilar Application has been filed (such as in an instance described in
Section 351(l)(9)(C) of the PHSA), then such Party shall promptly provide the
other Party with written notice. The terms “reference product” and “biosimilar
or interchangeable biological product” shall have the meanings given to such
terms in the BPCIA.

9.5.2.      Access to Confidential Information. Upon written request from
ImmunoGen, and to the extent permitted by Applicable Laws, Jazz shall provide
ImmunoGen’s counsel who meets the criteria set forth in PHSA Section
351(l)(1)(B)(ii) (“ImmunoGen’s Qualified Counsel”) with confidential access to
the Biosimilar Application and such other information provided by the Third
Party that submitted the Biosimilar Application (the “Applicant”) that describes
the process used to manufacture the Proposed Biosimilar Product, in each case,
(a) to the extent provided to Jazz by the Applicant and (b) only to the extent
necessary to determine which, if any, Licensed Patent Rights would be infringed
by the manufacture or sale of the Proposed Biosimilar Product; provided,
 however, that prior to receiving the Biosimilar Application and such
confidential information from Jazz, ImmunoGen shall confirm to Jazz and the
Applicant in writing its agreement to be subject to the confidentiality
provisions in Sections 351(l)(1)(B)(ii) and 351(l)(1)(B)(iii) of the PHSA. For
purposes of clarity, the Parties acknowledge and agree that, as set forth in
this Section 9.5, ImmunoGen has retained a right to participate in litigation
concerning any Licensed Patent Rights.

-73-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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9.5.3.      Initial Patent List.

(a)        Preparation of Initial Patent List. As soon as practicable after the
date of receipt by Jazz of a copy of a Biosimilar Application and related
manufacturing information and ImmunoGen’s receipt of notice contemplated by
Section 9.5.1, Jazz shall prepare and provide ImmunoGen with a list of those
patents within the Licensed Patent Rights that Jazz reasonably believes would be
infringed by the manufacture or sale of the Proposed Biosimilar Product (the
“Proposed Initial Patent List”). As soon as practicable following the date of
receipt by ImmunoGen of the Proposed Initial Patent List, ImmunoGen and Jazz
shall discuss in good faith the patents within the Licensed Patent Rights to be
included on the list to be sent to the Applicant under Section 351(l)(3)(A) of
the PHSA (the “Initial Patent List”), and Jazz shall consider in good faith
ImmunoGen’s proposals for changes to the Proposed Initial Patent List with
respect to the patents within the Licensed Patent Rights. Not later than [***]
days following Jazz’s receipt of the Biosimilar Application and related
manufacturing information and irrespective of whether Jazz has received comments
from ImmunoGen with respect to the Proposed Initial Patent List, Jazz shall
provide the Applicant with a copy of the Initial Patent List, which copy may be
redacted to delete all Patent Rights included in the Initial Patent List that
are not Licensed Patent Rights. Jazz shall have the right to include any of the
patents within the Licensed Patent Rights on the Initial Patent List to the
extent that Jazz reasonably believes that a claim of patent infringement for
such patent could be asserted by either ImmunoGen or Jazz; provided,  however,
that the right to control any suit or proceeding in which such a claim is
asserted shall be as set forth in Section 9.5.4.

(b)        Disclosure of the Applicant Response. Provided that ImmunoGen has
agreed to comply with the confidentiality provisions in Sections
351(l)(1)(B)(ii) and 351(l)(1)(B)(iii) of the PHSA and to the extent permitted
by Applicable Laws, Jazz shall provide to ImmunoGen Qualified Counsel any
response from the Applicant with regard to any patent within the Licensed Patent
Rights, including any response required under Section 351(l)(3)(B) of the PHSA
(the “Applicant Response”), within [***] days.

(c)        Preparation of Jazz Response. As promptly as practicable after the
date of receipt by Jazz of the Applicant Response, Jazz, with cooperation and
assistance from ImmunoGen as requested by Jazz, shall prepare and provide
ImmunoGen with a proposed response

-74-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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(the “Proposed Jazz Response”) that (i) describes on a claim-by-claim basis, how
each patent within the Licensed Patent Rights on the Initial Patent List would
be infringed by the commercial marketing of the Proposed Biosimilar Product, and
(ii) responds to the Applicant’s claims, if any, that the patents within the
Licensed Patent Rights on the Initial Patent List are invalid or unenforceable.
The Proposed Jazz Response shall include only the foregoing and shall not be
construed to include any proposed response to the Applicant relating to any
patents other than the Licensed Patent Rights; further, any actual response to
the Applicant under Section 351(l)(3)(C) of the PHSA (the “Jazz Response”) and
all decisions relating to subsequent procedures under the BPCIA with regard to
any patent other than those included within the Licensed Patent Rights shall be
within the sole discretion of Jazz. As soon as practicable following the date of
receipt by ImmunoGen of the Proposed Jazz Response, the Parties shall discuss in
good faith the statements in the Proposed Jazz Response and Jazz shall consider
in good faith ImmunoGen’s proposals for changes to the Proposed Jazz Response.
Not later than [***] days following Jazz’s receipt of the Applicant Response,
Jazz shall provide the Applicant with a copy of any portions of the Jazz
Response relating to the Licensed Patent Rights.

(d)        Negotiation; ImmunoGen Rights. After Jazz provides the Applicant with
a copy of the Jazz Response, Jazz shall commence good faith negotiations with
the Applicant for a period of not more than [***] days in an effort to reach
agreement on the patents on the Initial Patent List or on the Applicant’s list
pursuant to Section 351(l)(3)(B) of the PHSA (the “Infringed Patent List”) that
will be the subject of an immediate patent infringement litigation pursuant to
Section 351(l)(6) of the PHSA (an “Immediate Patent Infringement Action”);
provided,  however, that if the Initial Patent List includes both patents within
the Licensed Patent Rights that are [***] and patents that are [***] or are
[***], then Jazz shall not agree to the inclusion in the Infringed Patent List
of any [***] without the prior written consent of ImmunoGen, which consent shall
not be unreasonably withheld, conditioned or delayed. If Jazz and the Applicant
fail to reach agreement under Section 351(l)(4)(A) of the PHSA on the Infringed
Patent List, Jazz shall have the sole right to determine under Section
351(l)(5)(B) of the PHSA which patents of those on the Initial Patent List
should be the subject of an Immediate Patent Infringement Action; provided,
 however, that if the Initial Patent List includes both patents within the
Licensed Patent Rights that are Platform Patent Rights and patents that are
Product Patent

-75-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

Rights or are not within the Licensed Patent Rights, then Jazz shall not include
in the list of patents to be provided by Jazz to the Applicant pursuant to
Section 351(l)(5)(B)(i)(II) of the PHSA any Platform Patent Rights without the
prior written consent of ImmunoGen, which consent shall not be unreasonably
withheld, conditioned or delayed. Within [***] days following the exchange of
such lists by Jazz and the Applicant pursuant to Section 351(l)(5)(B)(i) of the
PHSA, Jazz shall, to the extent permitted by Applicable Laws, notify ImmunoGen
in writing of any Licensed Patent Rights included on the combined list(s)
referenced in Section 351(l)(6)(A) or (B) of the PHSA that will be the subject
of an Immediate Patent Infringement Action.

(e)        Supplements to Initial Patent List. ImmunoGen shall provide Jazz with
a copy of any U.S. patent within the Licensed Patent Rights that issues after
Jazz has provided the Initial Patent List to the Applicant within [***] days
after such issuance. As soon as practicable following the issuance of any such
patent, ImmunoGen and Jazz shall discuss in good faith whether such patent would
be infringed by the manufacture and/or sale of the Proposed Biosimilar Product.

9.5.4.      Claims, Suits and Proceedings.

(a)        Immediate Patent Infringement Action. With respect to any patents
within the Licensed Patent Rights that are to be the subject of an Immediate
Patent Infringement Action, the Parties’ respective rights and obligations with
respect to the litigation of such patents (including rights to initiate, step
in, participate in, settle and share amounts recovered pursuant to such
Immediate Patent Infringement Action, and obligations to pay legal costs and
expenses with respect to such Immediate Patent Infringement Action) shall be as
set forth in Sections 9.4.2 through 9.4.7, to the extent permitted by Applicable
Laws, except that the Party having the first right to file a claim for
Infringement against the Applicant with respect to any such patent subject to an
Immediate Patent Infringement Action shall file such claim within [***] days
after agreement is reached as to the Infringed Patent List under Section
351(l)(4)(A) of the PHSA or after the exchange of the lists under Section
351(l)(5)(B) of the PHSA, as applicable.

(b)        Premarketing Litigation. Either Party shall, within [***] days of
receiving any notice of commercial marketing provided by the Applicant pursuant
to Section 351(l)(8)(A) of the PHSA (the “Premarket Notice”), notify the other
Party. Thereafter,

-76-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

the Parties’ respective rights and obligations with respect to any litigation
pursuant to Section 351(l)(8)(B) of the PHSA (including rights to initiate, step
in, participate in, settle and share amounts recovered pursuant to such action,
and obligations to pay legal costs and expenses with respect to such action)
shall be as set forth in Sections 9.4.2 through 9.4.7, to the extent permitted
by Applicable Laws.

(c)        Cooperation; Standing. If a Party with the right to initiate legal
proceedings under this Section 9.5.4 lacks standing to do so (or lacks the right
under the BPCIA to do so) and the other Party has standing (or the sole right
under the BPCIA) to initiate such legal proceedings, such Party with standing or
such sole right shall initiate such legal proceedings at the request and expense
of the other Party, and the Party initiating such legal proceedings shall
provide such assistance and take such actions as the other Party may reasonably
request, at such other Party’s expense, to enable such other Party to exercise
its rights under this Section 9.5.4 to the fullest extent permitted by
Applicable Laws.

9.5.5.      Changes in Applicable Law. The Parties have agreed to the provisions
of this Section 9.5 on the basis of the BPCIA and other applicable laws and
regulations in effect as of the Effective Date. If there are any material
changes to the BPCIA or other Applicable Laws that would affect these
provisions, the Parties will discuss amendments to this Section 9.5 in good
faith.

9.6.      Invalidity or Unenforceability Defenses or Actions. In the event that
a Third Party asserts, as a defense or as a counterclaim in any infringement
action under Section 9.4.2, 9.4.3, 9.5.4 or 9.5.5, that any of the Licensed
Patent Rights is invalid or unenforceable, then the Parties’ respective rights
and obligations with respect to the response to such defense or the defense
against such counterclaim, as applicable, (including rights to initiate, step
in, participate in, settle and share amounts recovered pursuant to such action,
and obligations to pay legal costs and expenses with respect to such action)
shall be as set forth in Sections 9.4.2 through 9.4.7, to the extent permitted
by Applicable Laws; provided that for these purposes any such defense or
counterclaim shall be deemed to be an Infringement. In all other cases,
including any declaratory judgment action or similar action or claim filed by an
Applicant asserting that any of the Licensed Patent Rights is invalid or
unenforceable (as in a declaratory judgment action brought by the

-77-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Applicant following the Premarket Notice), then the Parties’ respective rights
and obligations with respect to such action (including rights to initiate, step
in, participate in, settle and share amounts recovered pursuant to such action,
and obligations to pay legal costs and expenses with respect to such action)
shall be as set forth in Sections 9.4.2 through 9.4.7, to the extent permitted
by Applicable Laws; provided that for these purposes any such case shall be
deemed to be an Infringement.

9.7.      Defense of Claims. If any action, suit or proceeding is brought or
threatened against either Party or an Affiliate or Sublicensee alleging
infringement of the Technology or Patent Rights of a Third Party by reason of
use by a Party, an Affiliate of a Party or a Sublicensee of the Licensed
Intellectual Property in the Development, manufacture, use or Commercialization
of the Licensed Product, the Party first receiving notice of such actual or
threatened action, suit or proceeding shall notify the other Party promptly, and
the Parties shall as soon as practicable thereafter confer in good faith
regarding the best response. The Parties acknowledge and agree that in the event
any such action, suit or proceeding is Third Party Claim for which either party
has indemnification obligations under Article 13 (Indemnification; Liability),
in addition to such conferring in good faith as set forth in this Section 9.7,
the Parties will otherwise follow the procedures set forth in Article 13
(Indemnification; Liability).

9.8.      Trademarks. All Licensed Product shall be sold under one or more
trademarks and trade names selected and owned by Jazz or its Affiliates or
Sublicensees in the Territory. As between the Parties, Jazz shall control the
preparation, prosecution and maintenance of applications related to all such
trademarks and trade names in the Territory, at its sole cost and expense and at
its sole discretion. ImmunoGen shall notify Jazz promptly upon learning of any
actual, alleged or threatened infringement of a trademark or trade name
applicable to the Licensed Product in the Territory, or of any unfair trade
practices, trade dress imitation, passing off of counterfeit goods, or like
offenses in the Territory. As between the Parties, all of the costs, expenses
and legal fees in bringing, maintaining and prosecuting any action to maintain,
protect or defend any trademark owned by Jazz or its Sublicensee hereunder, and
any damages or other recovery, shall be Jazz’s sole responsibility, and taken in
its sole discretion.

-78-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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9.9.      Patent Term Extensions. In connection with the Regulatory Approval of
the Licensed Product, Jazz shall consult with ImmunoGen before determining which
patent, if any, is to be extended, by way, for example, of a patent term
restoration and/or a supplementary protection certificate. Jazz shall not have
the right to extend any [***] without the prior written consent of ImmunoGen. In
jurisdictions where, by Applicable Laws, only one patent per product can be
extended, Jazz shall have the sole discretion to determine whether [***] is to
be extended and, in all other jurisdictions, either Party may designate Patent
Rights to be extended, provided that ImmunoGen’s decision to extend the term of
a particular Licensed Patent Right does not prevent Jazz from extending the term
of another Patent Right. ImmunoGen shall cooperate with Jazz to the extent
reasonably requested by Jazz to effectuate the intent of this Section 9.9.

9.10.    Bankruptcy. All rights and licenses granted under this Agreement are,
and shall be deemed to be, for purposes of Section 365(n) of the United States
Bankruptcy Code, licenses of rights to “intellectual property” as defined under
Section 101(56) of the United States Bankruptcy Code.

10.      TERM AND TERMINATION

10.1.    Term. Except with respect to Articles 8 and 14, which shall go into
effect as of the Signing Date, the term of this Agreement shall commence on the
Effective Date and shall expire on a country-by-country basis upon the
expiration of the Royalty Term in such country (the “Term”). Provided this
Agreement has not been terminated prior thereto by ImmunoGen under Section
10.2.2 or 10.2.3 or by Jazz under Section 10.2.1, following the expiration of
the Royalty Term in a country in accordance with Section 6.5, Jazz and its
Affiliates shall have a fully paid-up, irrevocable, freely transferable and
sublicensable, non-exclusive license under the relevant unpatented (or no longer
patented) Licensed Technology, to Develop, make, have made, use, sell, offer for
sale, import and otherwise Commercialize the Licensed Product in such country.

10.2.    Termination. Subject to the other terms of this Agreement:

10.2.1.      Voluntary Termination by Jazz. Jazz shall have the right to
terminate this Agreement at any time upon not less than [***] days’ prior
written notice to ImmunoGen.

-79-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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10.2.2.      Termination for Breach. Either Party may terminate this Agreement,
effective upon written notice to the other Party, upon any material breach by
the other Party of this Agreement that remains uncured [***] days ([***] days if
the breach is a failure by the other Party to make any payment required
hereunder) after the non-breaching Party first gives written notice of such
breach to the other Party describing such material breach in reasonable detail;
provided,  however, that if the nature of the asserted breach (other than a
breach for non-payment) is such that more than [***] days are reasonably
required to cure, then the cure period shall be extended for a period not to
exceed an additional [***] days so long as the Party seeking to cure the
asserted breach is [***]. Anything contained in this Agreement to the contrary
notwithstanding and subject to the proviso of this sentence, if the allegedly
breaching Party (a) disputes either (i) whether a material breach has occurred
or (ii) whether the material breach has been timely cured, and (b) provides
written notice of such dispute to the other Party within the above time periods,
then the matter will be addressed under the dispute resolution provisions of
Section 14.13, and the Party asserting the breach may not terminate this
Agreement until it has been finally determined under Section 14.13 that the
allegedly breaching Party is in material breach of this Agreement, and such
breaching Party further fails to cure such breach within [***] days ([***] days
if the breach is a failure by a Party to make any payment required hereunder)
after the conclusion of the dispute resolution procedure. Anything contained in
this Agreement to the contrary notwithstanding, if the asserted material breach
is cured or shown to be non-existent within the applicable cure period, the
first notice of breach hereunder shall be deemed automatically withdrawn and of
no effect. For the avoidance of doubt, Jazz’s failure to pay the upfront payment
pursuant to Section 6.1 shall be a material breach of this Agreement.

10.2.3.      Termination for Insolvency. To the extent not prohibited by
Applicable Laws, if either Party files for protection under bankruptcy laws,
makes an assignment for the benefit of creditors, appoints or suffers the
appointment of a receiver or trustee over its property, files a petition under
any bankruptcy or insolvency act or has any such petition filed against it which
is not discharged within sixty (60) days of the filing thereof, then the other
Party may terminate this Agreement effective immediately upon written notice to
such Party.

-80-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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10.3.    Termination for Safety Concerns. If Jazz has any significant safety
concerns regarding the Development and Commercialization of the Licensed Product
and is considering terminating this Agreement pursuant to this Section 10.3,
then at least [***] days prior to sending any notice of termination pursuant to
this Section 10.3, Jazz shall send ImmunoGen written notice describing such
safety concern and informing ImmunoGen that Jazz is considering its options to
address such concerns, which may include terminating this Agreement pursuant to
this Section 10.3. At ImmunoGen’s request, the Parties will engage in good faith
discussions regarding any such potential termination. After the expiration of
such [***] day period, Jazz may terminate this Agreement if Jazz determines in
good faith, based on a review of clinical data or other information, that
ceasing the Development and Commercialization of the Licensed Product is
warranted due to significant safety concerns; such termination shall be
effective immediately upon Jazz’s written notice to ImmunoGen.

10.4.    HSR Waiting Period. If (i) Jazz has not filed an HSR Filing within
[***] Business Days after the Signing Date and has not notified ImmunoGen prior
to such date that it does not believe that an HSR Filing is necessary in
connection with this Agreement, or (ii) the Effective Date has not occurred
within [***] days following the Signing Date, or such date as the Parties may
mutually agree, this Agreement may be terminated by either Party upon written
notice to the other. If this Agreement is terminated pursuant to this Section
10.4, then, notwithstanding any provision in this Agreement to the contrary,
neither Party will have any further obligation to the other Party with respect
to the subject matter of this Agreement. ImmunoGen shall provide Jazz with such
assistance and cooperation, at ImmunoGen’s expense, as necessary or reasonably
requested by Jazz to effectuate an HSR filing.

10.5.    Termination due to Material Adverse Event. This Agreement will
terminate in its entirety if a Material Adverse Event has occurred and Jazz
provides notice of termination to ImmunoGen, within [***] Business Days after
the Schedule Revision Date, that such Material Adverse Event has occurred.

10.6.    Consequences of Voluntary Termination or Termination for Breach or
Insolvency. Upon termination of this Agreement by either Party under Section
10.2, the following provisions shall apply:

-81-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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10.6.1.      the license granted by ImmunoGen to Jazz and its Affiliates
pursuant to Section 2.1.1 shall immediately terminate;

10.6.2.      Jazz shall immediately cease, and shall cause its Affiliates and
Sublicensees immediately to cease, any and all Development, manufacture, use and
Commercialization of the Licensed Product in the Territory, provided that Jazz
and its Affiliates and Sublicensees may, sell or otherwise dispose of all
Licensed Product then on hand, subject to the payment of royalties pursuant to
Section 6.4 and the other terms of this Agreement for a period of (a) [***]
consecutive months following the effective date of such termination if ImmunoGen
does not elect in writing within [***] Business Days of the effective date of
such termination to purchase from Jazz [***] inventory of Licensed Product, at a
cost equal to (i) for inventory [***], the [***] related to such inventory, (ii)
[***] for such inventory purchased for use in [***] (and not described in clause
(i)), and (iii) [***] plus [***] for such inventory purchased for use in [***]
(and not described in clause (i)), provided that, to the extent ImmunoGen has
previously made payments for inventory of the Co-Development Product being
purchased, ImmunoGen shall be entitled to credit such previous payments (in the
aggregate) against such costs in (i)–(iii) above, or (b) [***] consecutive
months following the effective date of such termination if ImmunoGen elects in
writing within [***] Business Days of the effective date of such termination to
purchase from Jazz [***] inventory of Licensed Product, at a cost equal to (A)
for inventory [***], the [***] related to such inventory, (B) [***] plus [***]
for such inventory purchased for use in [***] (and not described in clause (A)),
and (C) [***] for such inventory purchased for use in [***] (and not described
in clause (A)), provided that, to the extent ImmunoGen has previously made
payments for inventory of the Co-Development Product being purchased, ImmunoGen
shall be entitled to credit such previous payments (in the aggregate) against
such costs in (A)–(C) above, or in each case of (a) and (b) such longer period
(if any) to which the Parties mutually agree in writing (the “Wind-Down
Period”);

10.6.3.      each Party shall promptly return or destroy all Confidential
Information and Proprietary Materials of the other Party, provided that each
Party may retain, subject to Sections 4.3.5 and 8, (a) one (1) copy of the
Confidential Information of the other Party in its archives solely for the
purpose of establishing the contents thereof and ensuring compliance with

-82-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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its obligations hereunder, (b) any Confidential Information of the other Party
contained in laboratory notebooks or databases, (c) any computer records or
files containing such Confidential Information that have been created solely by
its automatic archiving and back-up procedures, to the extent created and
retained in a manner consistent with its standard archiving and back-up
procedures, but not for any other uses or purposes, and (d) any Confidential
Information of the other Party to the extent reasonably required to exercise its
rights and perform its obligations under the Collaboration and Option Agreement,
this Agreement, or any other Exclusive License Agreement;

10.6.4.      Jazz shall and hereby does, and shall cause all of its Affiliates
to, effective as of the effective date of termination, assign to ImmunoGen all
of its right, title and interest in and to (a) each trademark owned by Jazz or
its Affiliates under which the Licensed Product is sold and that exclusively
relates to the Licensed Product, and (b) all Regulatory Filings (including any
Regulatory Approvals), except where prohibited by Applicable Law, of Jazz, its
Affiliates, Sublicensees or their designees that exclusively relate to the
Licensed Product; provided that if any such Regulatory Filing is not immediately
transferable in a country, Jazz shall provide ImmunoGen with all benefit of such
Regulatory Filing, and such assistance and cooperation, at ImmunoGen’s expense
as necessary or reasonably requested by ImmunoGen to effectuate the transfer
such Regulatory Filing to ImmunoGen or its designee;

10.6.5.      the Licensed Product shall be deemed to be an ImmunoGen Product,
and in connection therewith, the Parties obligations with respect thereto shall
be as set forth in Article 11;

10.6.6.      Jazz shall and hereby does, and shall cause its Affiliates to,
effective as of the effective date of termination, grant to ImmunoGen an
exclusive right of reference, with the right to grant multiple tiers of further
rights of reference, in and to all Regulatory Filings (including all Regulatory
Approvals but excluding any Regulatory Filings or Regulatory Approvals required
for the general operation of Jazz’s facilities), except where prohibited by
Applicable Law, of Jazz, its Affiliates, Sublicensees, or their designees solely
to Develop, manufacture, use and Commercialize the Licensed Product and for
which Jazz does not have an assignment obligation under Section 10.6.4, provided
that ImmunoGen agrees to and shall reimburse Jazz for any Third

-83-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Party Payments with respect to the right of reference to any such Regulatory
Filings owned by a Third Party and Controlled by Jazz or its Affiliates;

10.6.7.      unless expressly prohibited by any Regulatory Authority, at
ImmunoGen’s written request, Jazz shall and hereby does, and shall cause its
Affiliates to cooperate with ImmunoGen to effect a smooth and orderly transfer
to ImmunoGen or its designee control of any or all clinical studies involving
the Licensed Product being conducted by or on behalf of Jazz or an Affiliate as
of the effective date of termination, in a manner that does not cause any
disruption to the conduct of any such clinical trial, provided that (a) if Jazz
terminates this Agreement pursuant to Section 10.2.1, Jazz will remain
responsible for its share of the Development Costs (i) for ImmunoGen to conduct
such ongoing clinical trials in accordance with the Development Plan during the
[***] month period immediately following the effective date of termination if
ImmunoGen elects to continue such clinical trial or (ii) to responsibly
wind-down such clinical trial if ImmunoGen elects not to continue such clinical
trial, (b) if ImmunoGen terminates this Agreement pursuant to Section 10.2.2,
Jazz will remain responsible for its share of the Development Costs (i) for
ImmunoGen to conduct such ongoing clinical trials in accordance with the
Development Plan during the [***] month period immediately following the
effective date of termination if ImmunoGen elects to continue such clinical
trial or (ii) to responsibly wind-down such clinical trial if ImmunoGen elects
not to continue such clinical trial and will be responsible for any reasonable
costs associated with transferring the clinical study to ImmunoGen, and (c) if
Jazz terminates this Agreement pursuant to Section 10.2.2, Jazz will remain
responsible for its share of the Development Costs to responsibly wind-down such
clinical trial if ImmunoGen elects not to continue such clinical trial;

10.6.8.      at ImmunoGen’s written request, Jazz shall provide complete copies
of the following, and at ImmunoGen’s written request, Jazz shall cause its
Affiliates to, assign to ImmunoGen or its designee (A) all material documents,
materials and data Controlled by Jazz, its Affiliates or Sublicensees that are
specific to the Licensed Product and were not previously provided to ImmunoGen
or generated by or on behalf of ImmunoGen and (B) all agreements entered into by
Jazz or any of its Affiliates, on the one hand, and one or more Third Parties,
on the other hand, in each case ((A) and (B)) that are necessary or reasonably
useful for the Development,

-84-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

manufacture, use or Commercialization of the Licensed Product, including, in the
case of clause (B) (a) any agreement pursuant to which Jazz or its Affiliates
receives any license or other rights to Develop, manufacture, use or
Commercialize the Licensed Product; (b) supply agreements pursuant to which Jazz
or its Affiliates obtains or will obtain quantities of the Licensed Product, (c)
clinical trial agreements, (d) contract research organization agreements, and
(e) service agreements, unless such agreement (i) expressly prohibits such
disclosure or assignment (in which case, Jazz or its Affiliate, as applicable,
shall use reasonable efforts to cooperate with ImmunoGen to secure the consent
of the applicable Third Party to such disclosure or assignment), or (ii) relates
to both the Licensed Product and products other than the Licensed Product (in
which case, at ImmunoGen’s request and expense, Jazz or its Affiliate, as
applicable shall use reasonable efforts to cooperate with ImmunoGen to secure
the written agreement of the applicable Third Party to a partial assignment of
the applicable agreement relating to the Licensed Product), provided that Jazz’s
obligations under this Section 10.6.8 shall terminate three (3) months after the
effective date of termination;

10.6.9.      the obligations set forth in Sections 10.6.1 through 10.6.8 shall
also apply to any Sublicensee solely to the extent that such Sublicensee does
not receive a direct license from ImmunoGen following termination of this
Agreement; and

10.6.10.      the Parties shall negotiate, in good faith, a termination
agreement to address all other matters related to termination that are
determined by the Parties to be necessary at the time of such termination,
provided that execution of such termination agreement shall not be a condition
to termination of this Agreement.

Notwithstanding the foregoing, unless ImmunoGen specifies in writing to the
contrary, no such termination of this Agreement shall be construed as a
termination of any valid sublicense to any Sublicensee hereunder, and thereafter
each such Sublicensee shall be considered a direct licensee of ImmunoGen
pursuant to the applicable terms and conditions of this Agreement, provided that
(a) such Sublicensee is then in full compliance with all terms and conditions of
its sublicense, (b) all accrued payment obligations to ImmunoGen hereunder have
been paid, (c) ImmunoGen shall not be subject to any obligations with respect to
such sublicense that are not included in this Agreement, and (d) such
Sublicensee agrees that within [***] Business Days after

-85-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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the effective date of such termination to assume all pertinent obligations of
Jazz under this Agreement.

10.7.    Consequences of Termination for Safety Reasons. Upon termination by
Jazz pursuant to Section 10.3, (a) the provisions of Section 10.6.1, Section
10.6.3, Section 10.6.4, Section 10.6.5, Section 10.6.6, and Section 10.6.8 shall
apply, (b) Jazz shall immediately begin responsibly winding-down any ongoing
clinical trials (including preparing any report for such ongoing clinical trials
required under Applicable Law) and ImmunoGen shall reimburse Jazz for [***] of
the costs to wind-down any clinical trials where development costs were shared,
(c) Jazz shall immediately cease, and shall cause its Affiliates and
Sublicensees immediately to cease, any and all Development, manufacture, use and
Commercialization of the Licensed Product in the Territory, (d) at the request
of ImmunoGen, ImmunoGen may purchase from Jazz any of Jazz’s remaining inventory
of Licensed Product at a cost equal to (i) [***], the [***] related to such
inventory, (ii) [***] for such inventory purchased for use in [***] (and not
described in clause (i)), and (iii) [***] for such inventory purchased for use
in [***] (and not described in clause (i)), provided that, to the extent
ImmunoGen has previously made payments for inventory of the Co-Development
Product being purchased, ImmunoGen shall be entitled to credit such previous
payments (in the aggregate) against such costs in (i)–(iii) above; provided
further that, ImmunoGen shall relabel any such Licensed Product to remove any of
Jazz’s logos and trademarks from the packaging, and (e) the [***] for ImmunoGen
set forth in [***] shall be [***] prior to [***] of the ImmunoGen Product in the
United States, (ii) [***] covering [***] of the ImmunoGen Product for the at
least [***] years after [***] for such ImmunoGen Product [***] and until the
provisions of subsection (iii) apply, and (iii) [***] for [***] of the ImmunoGen
Product [***] after [***] of the ImmunoGen Product [***] only if ImmunoGen has
[***] related to the applicable ImmunoGen Product during such [***]-year period.
The defined term Regulatory Approval as used in this Section 10.7 shall apply
mutatis mutandis with respect to ImmunoGen Products.

10.8.    Alternative to Termination. If this Agreement could be terminated by
Jazz under Section 10.2.2, then Jazz may elect, in its sole discretion, not to
terminate this Agreement and may instead provide notice to ImmunoGen of its
election to continue this Agreement pursuant to the following terms:

-86-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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10.8.1.      The exclusive license granted by ImmunoGen to Jazz pursuant to
Section 2.1.1 shall survive on a country-by-country basis until the expiration
of the Royalty Term for the Licensed Product in each such country, subject to
Jazz’s payment of [***] each milestone payment under Section 6.3 and [***]
royalty payments otherwise due under Section 6.4 (subject to applicable
reductions in Sections 6.4.2, 6.4.3, and 6.4.4) under and in accordance with
this Agreement with respect thereto from and after the date of such election;

10.8.2.      if the material breach by ImmunoGen related to the payment by
ImmunoGen of its share of Development Costs as required pursuant to Section 6.2,
the provisions of Section 6.2 shall terminate and from and after the date of
such election, Jazz shall bear all Development Costs incurred with respect to
activities conducted hereunder; and

10.8.3.      all other terms of this Agreement will remain in full force and
effect.

10.9.    Remedies. Except as otherwise expressly set forth in this Agreement,
the termination provisions of this Section 10 are in addition to any other
relief and remedies available to either Party at law or in equity.

10.10.  Surviving Provisions. Notwithstanding any provision herein to the
contrary, the rights and obligations of the Parties set forth in Article 1 (to
the extent used in any surviving provisions), Sections 4.3.3, 4.3.4, 4.3.5, 4.4,
4.5, 6.6, 6.7, 6.8, 8.1, 8.2, 8.4, 9.1, 9.10, 10.1, 10.4, 10.6, 10.7, 10.9,
10.10, Article 11 (for the duration of the applicable ImmunoGen Royalty Term or
as otherwise specified therein), Section 12.3 and Articles 13 and 14 as well as
any rights or obligations otherwise accrued hereunder (including any accrued
payment obligations) shall survive the expiration or termination of the Term of
this Agreement, as well as any other provisions that, by their intent or meaning
under the circumstances, are intended to survive. Without limiting the
generality of the foregoing, Jazz shall remain liable for all payment
obligations accruing hereunder prior to the effective date of termination.

11.       IMMUNOGEN PRODUCT

11.1.    Development Responsibility and Authority. Upon becoming the ImmunoGen
Product (the “ImmunoGen Product Effective Date”), ImmunoGen shall have sole
authority and

-87-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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responsibility for the Development, manufacture, use and Commercialization of
the ImmunoGen Product, including,: (i) the conduct of all research and
pre-clinical Development activities (including all pre-clinical and IND-enabling
studies (including, toxicology testing), any pharmaceutical development work on
formulations and process development relating to the ImmunoGen Product); (ii)
all activities related to human clinical trials; (iii) all activities relating
to the manufacture and supply of the ImmunoGen Product (including all required
process development and scale up work with respect thereto); and (iv) all
Commercialization activities relating to the ImmunoGen Product (including
marketing, promotion, sales, distribution, import and export activities and any
post-marketing trials and safety surveillance). Without limiting the generality
of the foregoing, as between the Parties, ImmunoGen shall have full control and
authority and sole responsibility for (A) making all Regulatory Filings for the
ImmunoGen Product and filing all Drug Approval Applications and otherwise
seeking all Regulatory Approvals regarding such matters and (B) the reporting of
all adverse events to Regulatory Authorities if and to the extent required by
Applicable Laws.

11.2.    Grant of Rights. Jazz shall, and does hereby, and shall cause its
Affiliates to, as of the ImmunoGen Product Effective Date, grant to ImmunoGen
and its Affiliates a worldwide, perpetual, irrevocable, royalty-bearing,
sublicensable, exclusive right and license, under the Licensed Jazz Intellectual
Property, to Develop, make, have made, use, sell, offer for sale, import and
otherwise Commercialize the ImmunoGen Product in the Territory. Except as
specifically set forth herein, neither Party grants to the other Party or its
Affiliates any rights or licenses to any intellectual or other proprietary
property owned or controlled by that Party.

11.3.    Financial Terms.

11.3.1.     Payment of Royalties; ImmunoGen Royalty Term. Commencing on the date
of First Commercial Sale of each ImmunoGen Product in any country or
jurisdiction, ImmunoGen shall pay to Jazz the following royalties, as calculated
on a product-by-product basis by multiplying the applicable royalty rates below
by the corresponding amount of incremental ImmunoGen Net Sales of the ImmunoGen
Product sold by ImmunoGen, its Affiliates and its ImmunoGen Licensees during the
applicable royalty terms (each, an “ImmunoGen Royalty Term”):

-88-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

(a)        If ImmunoGen terminates this Agreement pursuant to Section 10.2.3
(Termination for Insolvency) or pursuant to Section 10.2.2 (Termination for
Breach), then with respect to the resulting ImmunoGen Product(s) ImmunoGen shall
pay to Jazz a royalty equal to [***] of ImmunoGen Net Sales on a
country-by-country basis for a term of [***] from the date of First Commercial
Sale of such ImmunoGen Product in such country;

(b)        If Jazz terminates this Agreement pursuant to Section 10.2.1
(Voluntary Termination) or pursuant to Section 10.3 (Safety Concerns), then
ImmunoGen shall pay to Jazz a royalty equal to [***] of ImmunoGen Net Sales on a
country-by-country basis, for a term of [***] from the date of First Commercial
Sale of such ImmunoGen Product in such country;

(c)        If Jazz terminates this Agreement pursuant to Section 10.2.3
(Termination for Insolvency) or pursuant to Section 10.2.2 (Termination for
Breach), then with ImmunoGen shall pay to Jazz a royalty equal to [***] of
ImmunoGen Net Sales on a country-by-country basis for a term of [***] years from
the date of First Commercial Sale of such ImmunoGen Product in such country.

11.3.2.     Third Party Royalty Offset. Subject to Section 11.3.4, if, with
respect to a Calendar Quarter, ImmunoGen or any of its Affiliates or ImmunoGen
Licensees [***] to one or more Third Parties [***] any rights to any
intellectual property that are [***] the ImmunoGen Product in any country
(collectively, “ImmunoGen Third Party Payments”), then ImmunoGen shall have the
right to reduce the royalties otherwise due to Jazz pursuant to Section 11.3.1
with respect to Net Sales in such country of the ImmunoGen Product in such
Calendar Quarter by an amount equal to [***] of the amount of such ImmunoGen
Third Party Payments; provided,  however, if ImmunoGen or any of its Affiliates
or ImmunoGen Licensees obtains rights to any intellectual property subject to
this Section 11.3.2 that is [***], then (i) with respect to any ImmunoGen Third
Party Payment made pursuant to such license agreement that became due because of
an event pertaining [***] to [***], ImmunoGen may reduce the royalties pursuant
to this Section 11.3.2 by [***] of such ImmunoGen Third Party Payment, (ii) with
respect to any ImmunoGen Third Party Payment made pursuant to such license
agreement that became due because of an event [***] specifically to [***],
ImmunoGen shall [***], and (iii) with respect to any other ImmunoGen Third Party
Payment made pursuant to such license agreement, then the

-89-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

amount by which ImmunoGen may reduce the royalties pursuant to this Section
11.3.2 on account of such ImmunoGen Third Party Payment shall be [***] (e.g., if
the intellectual property [***], then ImmunoGen may deduct [***] of such
ImmunoGen Third Party Payment). For the avoidance of doubt, with respect to the
ImmunoGen Product, this Section 11.3.2 shall not apply to any ImmunoGen Third
Party Payments payable by ImmunoGen or any of its Affiliates or ImmunoGen
Licensees under any license or other agreement, written or oral, between
ImmunoGen or any of its Affiliates or ImmunoGen Licensees, on the one hand, and
any Third Party, on the other hand, in existence as of the date such ImmunoGen
Product became an ImmunoGen Product.

11.3.3.     Generic Competition. If ImmunoGen Generic Competition exists with
respect to the ImmunoGen Product in a country in the Territory in a Calendar
Quarter during the applicable ImmunoGen Royalty Term, then the royalties payable
with respect to Net Sales of the ImmunoGen Product sold by ImmunoGen, its
Affiliates, and its ImmunoGen Licensees in such country for such Calendar
Quarter shall be reduced by [***] of the royalties otherwise owed to Jazz
pursuant to Section 11.3.1, as applicable.

11.3.4.     Minimum Royalty Rate. Anything contained in this Article 11 to the
contrary notwithstanding, none of the reductions to royalties provided in
Section 11.3.2 or 11.3.3, shall, individually or in the aggregate, reduce the
royalties payable with respect to ImmunoGen Net Sales of the ImmunoGen Product
sold by ImmunoGen, its Affiliates and ImmunoGen Licensees in any country during
the applicable royalty term by more than [***] of the royalties otherwise owed
to Jazz pursuant to Section 11.3.1 without giving effect to any royalty
reduction provided in Sections 11.3.2 and 11.3.3.

11.3.5.     Payment of Royalties. ImmunoGen shall make any royalty payments owed
to Jazz in U.S. Dollars, quarterly within [***] days following the end of each
Calendar Quarter for which such royalties are deemed to occur (as provided in
the next sentence), using the wire transfer provisions of Section 6.6.4.
Determination of when a sale of any ImmunoGen Product occurs for purposes of
this Agreement shall be made when the revenue from such sale is recognized by
ImmunoGen in accordance with ImmunoGen Accounting Standards or, in the case of
ImmunoGen Licensees, in accordance with such ImmunoGen Licensees’ respective
revenue recognition accounting standards, consistently applied. Each royalty
payment shall be

-90-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

accompanied by a report for each country in which sales of the ImmunoGen Product
occurred in the Calendar Quarter covered by such statement, specifying each of:
(i) the gross sales (if available) and the ImmunoGen Net Sales in each country’s
currency of the ImmunoGen Product during the reporting period by ImmunoGen and
its Affiliates and ImmunoGen Licensees (specifying in reasonable detail each of
the deductions to gross sales used to calculate ImmunoGen Net Sales); (ii) the
applicable exchange rate to convert each country’s currency to U.S. Dollars
under Section 11.3.6; (iii) the applicable royalty rate(s) under Section 11.3.1
(specifying in reasonable detail each adjustment, if any, to the royalty rate(s)
as provided in Sections 11.3.2 and 11.3.3 ); and (iv) the royalties payable, in
U.S. Dollars, which shall have accrued hereunder with respect to such ImmunoGen
Net Sales. ImmunoGen shall provide Jazz with a non-binding estimate of its
royalty payments owed to Jazz for each Calendar Quarter at least [***] days
before the end of such Calendar Quarter.

11.3.6.     Accounting. All payments hereunder shall be made in U.S. Dollars.
Royalties shall be calculated based on Net Sales in U.S. Dollars, with the
conversion of Net Sales in each country to U.S. Dollars according the ImmunoGen
Standard Exchange Rate Methodology.

11.3.7.     No Set-Off; Tax Withholding. All payments made by ImmunoGen to Jazz
hereunder shall be made without set-off or counterclaim and free and clear of
any taxes, duties, levies, fees or charges, except for withholding taxes, if
any. ImmunoGen shall make any applicable withholding payments due on behalf of
Jazz and shall provide Jazz with reasonable proof of payment of such withholding
taxes, together with an accounting of the calculations of such taxes, within
[***] days after such payment is remitted to the proper authority. Any withheld
tax remitted by ImmunoGen to the proper authority shall be treated as having
been paid by ImmunoGen to Jazz for all purposes of this Agreement. The Parties
shall cooperate reasonably in completing and filing documents required under the
provisions of any Applicable Laws in connection with the making of any required
withholding tax payment, or in connection with any claim to a refund of or
credit for any such payment.

11.3.8.     Wire Transfers. All payments by either Party hereunder shall be made
in U.S. Dollars by bank wire transfer in immediately available funds to the
account designated the receiving Party by written notice to paying Party from
time to time.

-91-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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11.3.9.     Overdue Payments. Subject to the other terms of this Agreement, any
payments hereunder not paid within the applicable time period set forth herein
shall bear interest from the due date until paid in full, at a rate per annum
equal to the lesser of (a) [***], or (b) the maximum interest rate permitted by
Applicable Law in regard to such payments, calculated in each case from the date
such payment was due through to the date on which payment is actually made;
provided,  however, that with respect to any disputed payments, no interest
payment is due until such dispute is resolved and the interest payable thereon
will be based on the finally resolved amount of such payment, calculated from
the original date on which the disputed payment was due through the date on
which payment is actually made. Such interest and the payment and acceptance
thereof shall not negate or waive the right of a Party to any other remedy,
legal or equitable, to which it may be entitled because of the delinquency of
the payment.

11.3.10.   Records Retention; Audit.

(a)        ImmunoGen and its Affiliates and ImmunoGen Licensees shall keep for
at least [***] years from the end of the Calendar Year to which they pertain
complete and accurate records of the ImmunoGen Net Sales of the ImmunoGen
Product incurred by ImmunoGen or its Affiliates or ImmunoGen Licensee in
sufficient detail to allow the accuracy of the royalties paid to Jazz to be
confirmed.

(b)        Section 6.8.2 (Audit) shall apply mutatis mutandis with respect to
the relevant records required to be maintained pursuant to Section 11.3.10(a).

12.       REPRESENTATIONS AND WARRANTIES

12.1.    ImmunoGen Representations. ImmunoGen represents and warrants to Jazz
that, as of the Schedule Revision Date:

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

-92-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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12.1.2.      the execution and delivery of this Agreement and the performance of
the transactions contemplated hereby have been duly authorized by all
appropriate ImmunoGen corporate action;

12.1.3.      this Agreement is a legal and valid obligation binding upon
ImmunoGen and enforceable in accordance with its terms, and the execution,
delivery and performance of this Agreement by the Parties does not conflict with
or result in any default under any agreement, instrument or understanding to
which ImmunoGen is a party or by which it is bound;

12.1.4.      ImmunoGen has received no written notice from a Third Party
claiming that the use of the Licensed Intellectual Property pursuant to the
license granted hereunder to Jazz will infringe the issued patents of any such
Third Party [***];

12.1.5.      there is no pending or, to ImmunoGen’s Knowledge, threatened,
litigation that alleges that the use of the Licensed Intellectual Property
pursuant to the license granted hereunder to Jazz would infringe or
misappropriate any intellectual property rights of any Third Party;

12.1.6.      to its Knowledge, there is no actual, pending, alleged or
threatened infringement, misappropriation or other unauthorized use by a Third
Party of any of the Licensed Patent Rights or the Licensed Technology;

12.1.7.      the issued Licensed Patent Rights have not been invalidated and are
subsisting, and, to its Knowledge, [***] there are no pending or threatened
interference, re-examination, opposition or cancellation proceedings involving
any issued Licensed Patent Rights[***];

12.1.8.      it owns all right, title and interest in each of the Patent Rights
[***];

12.1.9.      it has provided to Jazz’s outside counsel for their review only a
true and correct copy of [***] such agreements are all in full force and effect,
it has not received any notice of any [***], and to its Knowledge, there [***];

-93-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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12.1.10.      it and its Affiliates have generated, prepared, maintained, and
retained all Regulatory Filings relating to the Licensed Product in accordance
with Applicable Law in all material respects, and all information contained in
such Regulatory Filings is true, complete and correct;

12.1.11.      it and its Affiliates have conducted, and their respective
contractors and consultants have conducted, all Development of the Licensed
Product prior to the Effective Date, including any and all pre-clinical and
clinical studies related to the Licensed Product, in accordance with Applicable
Law;

12.1.12.      neither it nor any of its Affiliates is or has been, and neither
it nor any of its Affiliates or contractors has used in any capacity in
connection with the Development of the Licensed Product, any Person who is or
has been: (i) debarred by the FDA under 21 U.S.C. § 335a, or to its Knowledge,
threatened with debarment by a pending proceeding, action, or investigation;
(ii) excluded from participation in any federal health care program, including
Medicare and Medicaid, the U.S. Department of Defense Military Health System,
and the U.S. Department of Veterans Affairs, pursuant to the Department of
Health and Human Services Office of Inspector General’s exclusion authority
under 42 U.S.C. § 1320a-7(a), as implemented by 42 C.F.R. Part 1001 et seq., or
the subject of an exclusion proceeding; or (iii) otherwise disqualified under 21
C.F.R. Part 58, subpart K or 21 C.F.R. § 312.7 or any other similar federal or
state law, or to its Knowledge, threatened with such disqualification by pending
proceeding, action, or investigation;

12.1.13.      [ImmunoGen has the right to use, disclose and reference for the
purposes contemplated in this Agreement, and to grant to Jazz to the extent
provided in this Agreement a [***] for the purposes contemplated in this
Agreement (a) [***] to ImmunoGen pursuant to the [***] that is related to the
Antibody contained in [***] or any ADC containing such Antibody, (b) [***] in
connection with research and development of the Antibody contained in [***] or
any ADC containing such Antibody and (c) all [***] that is related to [***];

-94-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

12.1.14.      [***] any patentable invention, Patent Rights or other
intellectual property rights [***] in the course of or as a result of [***];9

12.1.15.      no Technology or Patent Rights [***];

12.1.16.      to its Knowledge [***], there are no Technology or Patent Rights
[***]; and

12.1.17.      [(a) it has a [***], (b) it has [***], and (c) following [***] and
may [***], in each case [***]

12.2.    Jazz Representations. Jazz represents and warrants to ImmunoGen that,
as of the Signing Date and Effective Date:

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

12.2.2.      the execution and delivery of this Agreement and the performance of
the transactions contemplated hereby have been duly authorized by all
appropriate Jazz corporate action; and

12.2.3.      this Agreement is a legal and valid obligation binding upon Jazz
and enforceable in accordance with its terms, and the execution, delivery and
performance of this Agreement by the Parties does not conflict with or result in
any default under any agreement, instrument or understanding to which Jazz is a
party or by which it is bound.

12.3.    Warranty Disclaimers.

12.3.1.      Except as expressly set forth in Section 12.1, nothing in this
Agreement is or shall be construed as a warranty or representation by ImmunoGen
(a) as to the validity or scope of any patent application or patent within the
Licensed Patent Rights or (b) that anything

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9 [***]

-95-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

made, used, sold or otherwise disposed of under any license granted in this
Agreement is or will be free from infringement of patents, copyrights, and other
rights of Third Parties.

12.3.2.      EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER
PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EXPRESS OR
IMPLIED, WITH RESPECT TO ANY TECHNOLOGY, GOODS, SERVICES, RIGHTS OR OTHER
SUBJECT MATTER OF THIS AGREEMENT, AND EACH PARTY HEREBY DISCLAIMS ALL
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF TITLE, MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT.

12.4.    Anti-Corruption Laws. Without limiting the foregoing, each Party shall
comply with the United States Foreign Corrupt Practices Act (FCPA), the UK
Bribery Act 2010 or any other applicable equivalent laws (collectively
“Anti-Corruption Laws”), and shall not cause the other Party or its Affiliates,
directors, officers, shareholders, employees or agents to be in violation of any
Anti-Corruption Laws. Without limiting the foregoing, neither Party shall,
directly or indirectly, pay any money to, or offer or give anything of value to,
any “foreign official” as that term is used in the FCPA or any “foreign public
official” as that term is used in the FCPA, in order to obtain or retain
business or to secure any commercial or financial advantage for the other Party
or for itself or any of their respective Affiliates or Sublicensees.

13.       INDEMNIFICATION; LIABILITY

13.1.    Indemnification.

13.1.1.      Jazz Indemnity. Jazz shall indemnify, defend and hold harmless
ImmunoGen, its Affiliates, their respective directors, officers, employees,
consultants and agents, and their respective successors, heirs and assigns (the
“ImmunoGen Indemnitees”), from and against all liabilities, damages, losses and
expenses (including reasonable attorneys’ fees and expenses of litigation)
(collectively, “Losses”) incurred by or imposed upon the ImmunoGen Indemnitees,
or any of them, as a direct result of any Third Party claims, suits, actions,
demands or judgments, including personal injury and product liability matters
(collectively, “Third Party Claims”), arising out of (a) a breach of this
Agreement by Jazz, (b) the Development or

-96-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

Commercialization (including the production, manufacture, promotion, import,
sale or use by any Person) of the Licensed Product by Jazz or any of its
Affiliates, Sublicensees, subcontractors, distributors or agents, or (c) the
negligence, recklessness or willful misconduct of Jazz or any of its Affiliates,
Sublicensees, subcontractors, distributors or agents; except in each case to the
extent any such Third Party Claim or Losses result from (i) a breach of this
Agreement by ImmunoGen, (ii) the negligence, recklessness or willful misconduct
of ImmunoGen or any of its Affiliates, licensees, or subcontractors, (iii) the
conduct of any Development or Commercialization (including the production,
manufacture, promotion, import, sale or use by any Person) of the ImmunoGen
Product by or on behalf of ImmunoGen or any of its Affiliates, licensees,
subcontractors, distributors or agents or (iv) [***];provided that with respect
to any such Third Party Claim for which ImmunoGen also has an obligation to any
Jazz Indemnitee pursuant to Section 13.1.2, Jazz shall indemnify each ImmunoGen
Indemnitee for its Losses to the extent of Jazz’s responsibility, relative to
ImmunoGen (or to Persons for whom ImmunoGen is legally responsible), for the
facts underlying the Third Party Claim.

13.1.2.      ImmunoGen Indemnity. ImmunoGen shall indemnify, defend and hold
harmless Jazz, its Affiliates, their respective directors, officers, employees,
consultants and agents, and their respective successors, heirs and assigns (the
“Jazz Indemnitees”), from and against all Losses incurred by or imposed upon the
Jazz Indemnitees, or any of them, as a direct result of any Third Party Claims
arising out of (a) a breach of this Agreement by ImmunoGen, (b) the Development
or Commercialization (including the production, manufacture, promotion, import,
sale or use by any Person) of the ImmunoGen Product by or on behalf of ImmunoGen
or any of its Affiliates, sublicensees, subcontractors, distributors or agents,
(c) [[***]or (d) the negligence, recklessness or willful misconduct of ImmunoGen
or any of its Affiliates, Sublicensees, or subcontractors, except in each case
to the extent any such Third Party Claim or Losses result from a breach of this
Agreement by Jazz, or the negligence, recklessness or willful misconduct of Jazz
or any of its Affiliates, Sublicensees subcontractors, distributors or agents,
or the Development or Commercialization (including the production, manufacture,
promotion, import, sale or use by any Person) of the Licensed Product by Jazz or
any of its Affiliates, Sublicensees, subcontractors, distributors or agents;
provided that with respect to any such Third Party Claim for which Jazz also has
an obligation to any ImmunoGen Indemnitee pursuant to Section 13.1.1, ImmunoGen

-97-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

shall indemnify each Jazz Indemnitee for its Losses to the extent of ImmunoGen’s
responsibility, relative to Jazz (or to Persons for whom Jazz is legally
responsible), for the facts underlying the Third Party Claim.

13.2.    Procedure. A Person seeking indemnification under Section 13.1 (the
“Indemnified Party”) in respect of a Third Party Claim shall give prompt notice
of such Third Party Claim to the Party from which recovery is sought (the
“Indemnifying Party”) and shall permit the Indemnifying Party to assume
direction and control of the defense of the Third Party Claim, provided that the
Indemnifying Party shall act reasonably and in good faith with respect to all
matters relating to the defense or settlement of such Third Party Claim as the
defense or settlement relates to the Indemnified Party. The Indemnified Party,
its employees and agents, shall reasonably cooperate with the Indemnifying Party
and its legal representatives in the investigation and defense of such Third
Party Claim. The foregoing notwithstanding, the Indemnified Party shall have the
right to participate in, but not control, the defense of any Third Party Claim,
and request separate counsel, with such attorneys’ fees and expenses or
litigation to be paid by the Indemnified Party, unless (a) representation of
such Indemnified Party by the counsel retained by the Indemnifying Party would
be inappropriate due to actual or potential conflicting interests between such
Indemnified Party and any other Person represented by such counsel in such
proceedings, or (b) the Indemnifying Party has failed to assume the defense of
the applicable Third Party Claim, and in connection with either clause (a) or
(b) above, such reasonable attorneys’ fees and expenses of litigation shall be
paid by the Indemnifying Party. Neither the Indemnifying Party nor the
Indemnified Party shall settle or otherwise resolve such Third Party Claim
without the other’s prior written consent (which consent shall not be
unreasonably withheld, conditioned or delayed); provided that the Indemnifying
Party may, without the Indemnified Party’s prior written consent, agree or
consent to any settlement or other resolution of such Third Party Claim which
requires solely money damages paid by the Indemnifying Party, and which includes
as an unconditional term thereof the giving by such claimant or plaintiff to the
Indemnified Party of a release from all liability in respect of such Third Party
Claim.

13.3.    Insurance. During the Term and for a period of at least [***] years
thereafter (or for ImmunoGen, in the event ImmunoGen is developing or
commercializing ImmunoGen

-98-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

Products, for a period of at least [***] years after ImmunoGen ceases all
development and commercialization of such ImmunoGen Products), each Party shall
maintain on an ongoing basis without interruption comprehensive general
liability insurance in amounts customary for companies of comparable size and
stage of development or commercialization (taking into account a comparable
safety risk profile for the product under development) to such Party (but in any
event at least [***]) at all times during which [***] and of at least [***] at
all times during which [***])10 and any other insurance required by Applicable
Laws. All of such insurance coverage may be maintained through a self-insurance
plan that substantially complies with the foregoing limits and requirements.
Each Party shall use commercially reasonable efforts to provide the other Party
at least [***] days’ prior written notice of any cancellation to or material
change in its insurance coverage below the amounts and types described above.
Each such insurance policy shall contain a waiver of subrogation by the insurer,
or self-insurer as applicable, against Jazz or ImmunoGen, as the case may be.

13.4.    Limited Liability. [***], NEITHER PARTY WILL BE LIABLE WITH RESPECT TO
ANY SUBJECT MATTER OF THIS AGREEMENT UNDER ANY CONTRACT, NEGLIGENCE, STRICT
LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR ANY SPECIAL, INCIDENTAL,
INDIRECT, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES (INCLUDING ANY DAMAGES
RESULTING FROM LOSS OF PROFITS, LOSS OF BUSINESS OR LOSS OF GOODWILL TO THE
EXTENT THAT SUCH DAMAGES ARE NOT DIRECT DAMAGES), EVEN IF EITHER PARTY IS
INFORMED IN ADVANCE OF THE POSSIBILITY OF SUCH DAMAGES. For purposes of clarity,
a Party’s monetary liability under a Third Party Claim for such Third Party’s
special, incidental, indirect or consequential damages, or for any exemplary or
punitive damages payable to such Third Party in connection with such Third Party
Claim, shall be deemed to be the direct damages of such Party for purposes of
this Section 13.

 

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10 [***]

-99-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

14.       MISCELLANEOUS

14.1.      Notices. All notices and communications shall be in writing and
delivered personally or by courier or mailed via certified mail, return receipt
requested, postage prepaid, addressed as follows:

 

 

If to ImmunoGen:

ImmunoGen, Inc.

 

830 Winter Street

 

Waltham, MA 02451

 

United States of America

 

Attn: Vice President, Business Development

 

 

with a copy to:

ImmunoGen, Inc.

 

830 Winter Street

 

Waltham, MA 02451

 

United States of America

 

Attn: Legal Department

 

 

If to Jazz:

Jazz Pharmaceuticals Ireland Limited

 

Waterloo Exchange

 

Waterloo Road

 

Dublin 4

 

Ireland

 

Attn: Secretary

 

 

with a copy to:

Jazz Pharmaceuticals

 

3180 Porter Drive

 

Palo Alto, California 94304

 

United States of America

 

Attn: General Counsel

 

 

with a copy to:

Cooley LLP

 

3175 Hanover Street

 

Palo Alto, CA 94304-1130

 

United States of America

 

Attn: Marya A. Postner, Ph.D.

 

Except as otherwise expressly provided in this Agreement or mutually agreed in
writing, any notice, communication or document (excluding payment) required to
be given or made shall be deemed given or made and effective upon actual receipt
or, if earlier, (a) one (1) Business Day after deposit with a nationally
recognized overnight express courier with charges prepaid, or (b)

-100-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

[***] Business Days after mailed by certified mail, return receipt requested,
postage prepaid, in each case addressed to the receiving Party at its address
stated above or to such other address as such Party may designate by written
notice given in accordance with this Section 14.1.

14.2.    Governing Law. This Agreement shall be governed by and construed in
accordance with the laws of the State of New York without regard to any choice
of law principle that would dictate the application of the law of another
jurisdiction.

14.3.    Entire Agreement. This Agreement constitutes the entire agreement
between the Parties with respect to the subject matter hereof and supersedes any
prior or contemporaneous agreements or understandings, negotiations or
correspondence between the Parties, written or oral, concerning the subject
matter hereof.

14.4.    Amendment and Waiver. This Agreement may be amended, modified or
changed only by a written instrument executed by the Party to be bound. No term
of this Agreement will be deemed to have been waived and no breach excused,
unless such waiver or consent shall be in writing and signed by the Party
claiming to have waived or consented. Any consent by any Party to, or waiver of,
a breach by the other, whether express or implied, shall not constitute consent
to, or waiver of, or excuse for, any other different or subsequent breach.

14.5.    Binding Effect. This Agreement shall be binding upon and inure to the
benefit of the Parties and their respective successors and permitted assigns.
Except as set forth in Section 13.4, no Third Party (including employees of
either Party) shall have or acquire any rights by reason of this Agreement.

14.6.    Purpose and Scope. Nothing in this Agreement shall be construed to
establish any agency, employment, partnership, joint venture, franchise or
similar or special relationship between the Parties. Neither Party shall have
the right or authority to assume or create any obligations or to make any
representations, warranties or commitments on behalf of the other Party, whether
express or implied, or to bind the other Party in any respect whatsoever. Except
as expressly set forth elsewhere in this Agreement, neither Party grants to the
other Party any right or license to any of its intellectual property.

-101-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

14.7.    Headings. Section and subsection headings are inserted for convenience
of reference only and do not form part of this Agreement.

14.8.    Assignment. Neither Party may assign this Agreement without the prior
written consent of the other Party, which consent shall not be unreasonably
withheld, conditioned or delayed, except that such consent shall not be required
in connection with any assignment to an Affiliate of the assigning Party, or to
a Third Party in connection with a sale or transfer of the business to which
this Agreement relates, or to any successor Person resulting from any merger or
consolidation of such Party with or into such Person, provided that the assignee
shall have agreed in writing to assume all of the assignor’s obligations
hereunder, and provided,  further, that the other Party shall be notified
promptly after such assignment has been effected. Any such assignment shall not
relieve the assigning Party of any liabilities or obligations owed to the other
Party hereunder, including in the case of Jazz, the payment of any amounts
described in Article 6, and in the case of ImmunoGen, the payment of any amounts
described in Article 11. Any purported assignment of this Agreement in violation
of this Section 14.8 shall be null and void.

14.9.    Performance by Affiliates. Each Party may discharge any obligations and
exercise any right hereunder through any of its Affiliates. Each Party hereby
guarantees the performance by its Affiliates of such Party’s obligations under
this Agreement, and shall cause its Affiliates to comply with the provisions of
this Agreement in connection with such performance. Any breach by a Party’s
Affiliate of any of such Party’s obligations under this Agreement shall be
deemed a breach by such Party, and the other Party may proceed directly against
such Party without any obligation to first proceed against such Party’s
Affiliate.

14.10.   Force Majeure. Neither Party shall be liable for failure of or delay in
performing obligations set forth in this Agreement, and neither shall be deemed
in breach of its obligations, if such failure or delay is due to natural
disasters or any causes beyond the reasonable control of such Party, provided
that financial inability in and of itself shall not be considered to be a force
majeure event. In event of such force majeure, the Party affected thereby shall
use commercially reasonable efforts to cure or overcome the same and resume
performance of its obligations hereunder.

-102-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

14.11.   Interpretation. The Parties hereto acknowledge and agree that: (a) each
Party and its counsel reviewed and negotiated the terms and provisions of this
Agreement and have contributed to its revision; (b) the rule of construction to
the effect that any ambiguities are resolved against the drafting Party shall
not be employed in the interpretation of this Agreement; and (c) the terms and
provisions of this Agreement shall be construed fairly as to each Party hereto
and not in a favor of or against any Party, regardless of which Party was
generally responsible for the preparation of this Agreement. In addition, unless
the context otherwise requires, wherever used in this Agreement: (i) the
singular shall include the plural, the plural the singular; (ii) the use of any
gender shall be applicable to all genders; (iii) the words “include” or
“including” shall be construed as incorporating, also, “but not limited to” or
“without limitation” (irrespective of whether such words are used in the
applicable instance); (iv) the words “hereof,” “herein,” “hereby” and derivative
or similar words refer to this Agreement as a whole and not to any particular
provision of this Agreement; and (v) all references to “will” are
interchangeable with the word “shall” and shall be understood to be imperative
or mandatory in nature.

14.12.   Severability. If any provision of this Agreement shall be held by a
court of competent jurisdiction, or declared under any law, rule or regulation
of any government having jurisdiction over the Parties hereto, to be illegal,
invalid or unenforceable, then such provision will, to the extent permitted by
the court or government, not be voided, but will instead be construed to give
effect to the intentions of the Parties to the maximum extent permissible under
Applicable Laws, and the remainder of this Agreement will remain in full force
and effect in accordance with its terms.

14.13.   Dispute Resolution.

14.13.1.      Senior Officers. The Parties recognize that a bona fide dispute as
to certain matters may from time to time arise during the Term relating to
either Party’s rights or obligations hereunder or otherwise relating to the
validity, enforceability, interpretation, application, or performance of this
Agreement, including disputes relating to alleged breach or termination of this
Agreement but excluding any dispute under Section 14.13.3 (hereinafter, a
“Dispute”). In the event of the occurrence of any such Dispute, upon the written
request of either Party, the Parties shall refer such Dispute to their
respective senior officers designated below

-103-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

(“Senior Officers”), for attempted resolution by good faith negotiations
commencing within [***] days after such written notice is received. The Senior
Officers of the Parties are as follows:

For Jazz: A senior officer designated by Jazz at the time of the Dispute who has
settlement authority over the Dispute; and
For ImmunoGen: Chief Executive Officer.

If the Senior Officers are not able to resolve such Dispute within [***] days
following delivery of the notice referring the Dispute to the Parties’
respective Senior Officers, then either Party may then invoke the provisions of
Section 14.13.2.

14.13.2.   Arbitration.

(a)        CPR Rules. Except for Disputes subject to Section 14.13.3, any
Dispute that is not resolved pursuant to Section 14.13.1 shall be finally
resolved by arbitration in accordance with the International Institute for
Conflict Prevention and Resolution Rules for Administered Arbitration by three
arbitrators (the “Tribunal”), of whom each Party shall designate one, with the
third arbitrator to be designated by the two Party-designated arbitrators (each
such arbitration, an “Arbitration”). The Tribunal shall enforce and not modify
the terms of this Agreement. The place of Arbitration shall be the Borough of
Manhattan, City of New York, New York.

(b)        Award. Any award shall be promptly paid in U.S. Dollars free of any
tax, deduction or offset, and any costs, fees, or taxes incident to enforcing
the award shall, to the maximum extent permitted by law, be charged against the
Party resisting enforcement. Each Party shall abide by the award rendered in any
Arbitration conducted pursuant to this Section 14.13.2, and agrees, that subject
to the Federal Arbitration Act, judgment may be entered upon the final award in
a court of competent jurisdiction and that other courts may award full faith and
credit to such judgment in order to enforce such award. The award will include
interest from the date of any damages incurred for breach of the Agreement, and
from the date of the award until paid in full, at a rate fixed by the Tribunal.

-104-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

(c)        Costs. Except as set forth in Section 14.13.2(b), each Party shall
bear its own legal fees, costs and expenses. The Tribunal shall assess its
costs, fees and expenses against the Party losing the Arbitration unless
concludes that neither Party is the clear loser, in which case the Tribunal
shall divide its fees, costs and expenses according to its sole discretion.

(d)        Confidentiality. Except to the limited extent necessary to comply
with Applicable Law, legal process, or a court order or to enforce a final
settlement agreement or secure enforcement or vacatur or the Tribunal’s award,
the Parties agree that the existence, terms and content of any Arbitration, all
information and documents disclosed in any Arbitration or evidencing any
Arbitration results, award, judgment or settlement, or the performance thereof,
and any allegations, statements and admissions made or positions taken by either
Party in any Arbitration shall be treated and maintained in confidence and are
not intended to be used or disclosed for any other purpose or in any other
forum.

14.13.3.   Patent Disputes.

(a)        Inventorship. Any dispute, controversy or claim between the Parties
involving the inventorship of any inventions conceived or first actually reduced
to practice in conducting activities pursuant to this Agreement, including
disputes as to whether an invention was conceived or first actually reduced to
practice in conducting activities pursuant to this Agreement, that is not
resolved by mutual agreement of the Parties’ respective chief patent counsels
(or persons with similar responsibilities) within [***] days after the dispute
is raised by one or both of the Parties shall be submitted to an Independent
Patent Counsel for resolution. Such Independent Patent Counsel’s determination
of inventorship, absent manifest error, shall be final and binding on the
Parties; provided,  however, that any such determination with respect to any
inventions described or claimed in a patent application shall not preclude
either Party from disputing inventorship with respect to any different or
additional inventions described or claimed in any patent issuing from such
patent application, which disputes shall be resolved in accordance with this
Section 14.13.3(a). The Parties shall equally (50/50) share the Independent
Patent Counsel fees and expenses related to his or her determination of
inventorship.

-105-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

(b)        Other Patent Disputes. Any dispute, controversy or claim between the
Parties that involves the validity, scope, infringement, enforceability or
ownership of the Parties’ respective Patent Rights (i) that are pending or
issued in the United States shall be subject to actions before the United States
Patent and Trademark Office and/or submitted exclusively to the federal court
located in the jurisdiction [***], and (ii) that are pending or issued in any
other country (or region) shall be brought before an appropriate regulatory or
administrative body or court in that country (or region), and the Parties hereby
consent to the jurisdiction and venue of such courts and bodies.

14.14.   Interim Equitable Relief. Anything contained in this Agreement to the
contrary notwithstanding, if a Party reasonably requires relief on a more
expedited basis than would be possible pursuant to the procedures set forth in
Section 14.13, such Party may seek a temporary injunction or other interim
equitable relief in a court of competent jurisdiction, without posting a bond,
pending the resolution of the Dispute in accordance with Section 14.13. Any such
remedies will be in addition to all other remedies available by law or at equity
to the injured Party.

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

14.16.   Antitrust Filings.

14.16.1.      Unless Jazz notifies ImmunoGen in writing prior to the [***]
Business Day after the Signing Date that it believes that no HSR filing is
necessary, each of Jazz and ImmunoGen shall, within [***] Business Days after
Signing Date, file with the United States Federal Trade Commission (“FTC”), the
Antitrust Division of the United States Department of Justice (“DOJ”) and any
foreign governmental authority, any HSR Filing required of it under the HSR Act
with respect to the subject matter of this Agreement, which forms shall
specifically request early termination of the initial HSR Act waiting period.
The Parties shall cooperate with one another to the extent reasonably necessary
in the preparation of any such HSR Filing. Each Party is responsible for its own
costs and expenses. The Parties each agree to pay one-half of the filing fees
applicable to the HSR Filings.

-106-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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14.16.2.      Each of Jazz and ImmunoGen hereby covenants and agrees to use its
commercially reasonable efforts to secure, and not to take any action that will
have the effect of delaying, impairing or impeding, the early termination or
expiration of any waiting periods under the HSR Act for the transactions
contemplated hereby. The Parties shall each cooperate reasonably with one
another in connection with resolving any inquiry or investigation by the DOJ,
FTC or governmental authorities outside the United States relating to their
respective HSR Filings or the transactions contemplated hereby. Without limiting
the foregoing, each Party shall (a) promptly inform the other Party of any
written or oral communication received from DOJ, FTC or governmental authority
outside the United States relating to its HSR Filing or the transactions
contemplated hereby (and if in writing, furnish the other Party with a copy of
such communication); (b) respond as promptly as practicable to any request from
DOJ, FTC or governmental authority outside the United States for information,
documents or other materials in connection with a review of the transactions
contemplated hereby; (c) provide to the other Party, and permit the other Party
to review and comment in advance of submission, all proposed correspondence,
filings, and written communications to DOJ, FTC governmental authority outside
the United States with respect to the transactions contemplated hereby; and (d)
not participate in any substantive meeting or discussion with DOJ, FTC or
governmental authority outside the United States in respect of investigation or
inquiry concerning the transactions contemplated hereby unless it consults with
the other Party in advance and, except as prohibited by applicable Law, gives
the other Party the opportunity to attend and participate thereat. The Parties
shall consult and cooperate with each other, and consider in good faith the
views of one another, in connection with any analyses, appearances,
presentations, memoranda, briefs, arguments, opinions and proposals made or
submitted by or on behalf of any Party in connection with proceedings under or
relating to any antitrust law, except as may be prohibited or restricted by
Applicable Law.

14.16.3.      Nothing in this Section 14.16 requires either Party to consent to
the divestiture or other disposition of any of its or its Affiliates’ assets or
to consent to any other structural or conduct remedy, and each Party and its
Affiliates has no obligation to contest, administratively or in court, any
ruling, order or other action of the FTC, DOJ, any governmental authority
outside the United States or any Third Party respecting the transactions
contemplated by this Agreement.

-107-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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14.17.   Execution. This Agreement may be executed in two or more counterparts,
all of which when taken together shall be considered one and the same agreement
and shall become effective when counterparts have been signed by each Party and
delivered to the other Party, it being understood that both Parties need not
sign the same counterpart. If any signature is delivered by facsimile
transmission or by e-mail delivery of a “PDF” format data file, such signature
shall create a valid and binding obligation of the Party executing (or on whose
behalf such signature is executed) with the same force and effect as if such
facsimile or “PDF” signature page were an original thereof.

[Signature page follows]

-108-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized representatives.

 

 

 

 

 

IMMUNOGEN, INC.

    

JAZZ PHARMACEUTICALS IRELAND LIMITED

 

 

 

By:

 

 

By:

 

 

 

 

 

 

Name:

 

 

Name:

 

 

 

 

 

 

Title:

 

 

Title:

 

 

 

 

 

 

Date:

 

 

Date:

 

 

 

-109-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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EXHIBIT A

CO-DEVELOPMENT ADDITIONAL TERMS AND CONDITIONS

Except as expressly modified herein, all terms, conditions, covenants,
representations and warranties contained in the Agreement shall remain in full
force and effect. If any of the terms, conditions, covenants, representations
and warranties set forth in this Exhibit A conflict with, or are inconsistent
with the terms of the Agreement unmodified by this Exhibit A, as applied to the
Co-Development Product, the Co-Development Plan, or the Co-Development
Territory, the terms of this Exhibit A in such cases shall take precedence.

Upon ImmunoGen’s exercise of the ImmunoGen Opt-In Right and until such time as
ImmunoGen exercises the ImmunoGen Opt-Out Right (as defined below), the
following amendments to the Agreement shall be effective:

1.         Additional Definitions. Whenever used in this Exhibit A with an
initial capital letter, the terms defined in this Section 1 shall have the
meanings specified. Other capitalized terms shall have the meanings ascribed to
them in the Agreement.

1.1.      “Co-Development Plan” means the written plan describing the
Development activities to be carried out by the Parties during each Calendar
Year for the Co-Development Product developed in accordance with the terms of
this Agreement, as such written plan may be amended, modified or updated in
accordance with the terms of this Agreement. Such Co-Development Plan, and any
modification, amendment or update thereto, shall set forth, inter alia, the
specific objectives, projected achievement milestones, resource allocation
requirements, applicable budgets, and a proposed timeline for such activities.
The budget set forth in the Co-Development Plan is referred to herein as the
“Co-Development Plan Budget”.

1.2.      “Co-Development Territory” means the United States (including its
territories and possessions).11

 

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11 [***]

 

-110-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
406 of the Securities Act of 1933, as amended.

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1.3.      “Detail” means a face-to-face meeting, in an individual or group
practice setting, between [***] healthcare professionals and [***] ImmunoGen or
Jazz sales representative during which product information is communicated [***]
discussed during the meeting with the healthcare professional. For purposes of
determining a number of Details performed by a Party under this Agreement, [***]
shall be deemed to be [***]. For the avoidance of doubt, a communication
regarding a product that is [***].

1.4.      In the definition of “Net Sales” in the Agreement, references to the
Licensed Product will refer to the Co-Development Product for purposes of
Exhibit A-1, references to the Territory will refer to the Co-Development
Territory.

1.5.      The definition of “Jazz Intellectual Property” in the Agreement will
refer to any Patent Rights or Technology Controlled by Jazz as of the Effective
Date or that becomes Controlled by Jazz during the Term (including Jazz Product
Technology and Jazz’s interest in any Joint Product Technology) that is
necessary or useful for ImmunoGen to Commercialize the Licensed Product in the
Co-Development Territory in accordance with the Product Plan.

1.6.      “Product Plan” means the Product Plan with respect to the
Commercialization of the Co-Development Product in the Co-Development Territory
for the relevant Calendar Years, including an overall strategic plan for
Commercialization, a tactical plan to accomplish such strategy, a plan regarding
promotional educational/materials, subject to applicable compliance regulations,
a plan for medical affairs activities supporting such Co-Development Product,
sales force training, market research strategy, an advertising/public relations
plan, managed care/contracting strategy, sales force alignment, a sales force
deployment plan, pricing strategy and determination of pricing, and annual
forecasts including demand units and supply units (which forecasts the Parties
acknowledge and agree are non-binding and are not intended to provide any
assurance of future commercial success), and a budget for the foregoing
activities, in each case for the Co-Development Product in the Co-Development
Territory, as developed, approved and amended in accordance with this Agreement.
A budget for the foregoing activities related to the Co-Development Product in
the Co-Development Territory (the “Product Budget”) will be set forth in the
Product Plan.

-111-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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1.7.      “Product Out-of-Pocket Costs” means amounts paid to Third Party
vendors or contractors for services or materials provided by them directly in
the performance of activities under the Product Plan to the extent such services
or materials apply solely and directly to, or reasonably allocated to, the
Co-Development Product. For clarity, Product Out-of-Pocket Costs do not include
payments for a Party’s internal expenses or the out-of-pocket portion, if any,
of the following expenses of a Party (as opposed to its Third Party vendor or
contractor): salaries or benefits; facilities; utilities; general office or
facility supplies; insurance (other than clinical trial insurance and product
liability insurance); information technology, capital expenditures or the like.

2.         License. Subject to the terms and conditions of this Agreement, Jazz
shall, and does hereby, grant to ImmunoGen a non-exclusive, non-transferable
(except as expressly permitted in this Section 2), royalty-free right and
license to and under any Jazz Intellectual Property solely for ImmunoGen to
perform its obligations under this Agreement in connection with the
Commercialization of the Co-Development Product in the Co-Development Territory
in accordance with the Co-Development Plan and the terms of this Agreement.
ImmunoGen may grant sublicenses under the license granted to it under this
Section 2, or engage Third Party Service Providers as subcontractors to perform
its activities allocated to ImmunoGen under the Co-Development Plan, solely with
Jazz’s prior written consent.

3.         Joint Steering Committee. In addition to its responsibilities set
forth in Section 3.2.5 of the Agreement, the JSC shall serve as a forum for
resolution of disputes of the JIPC.

4.         Joint Development Committee. If the JDC has been disbanded, the JDC
shall be re-established with respect to Development of the Co-Development
Product pursuant to the Co-Development Plan until such time as the JDC
determines that the Development activities are completed.

5.         Joint Product Committee.

5.1.      Mandate and Establishment of Committee. Promptly following ImmunoGen’s
exercise of the ImmunoGen Opt-In Right with respect to the Licensed Product (the
“ImmunoGen Opt-In Date”), the Parties shall establish a joint product committee
(the “JPC”) to serve as a form for coordination and communication between the
Parties with respect to Commercialization of the

-112-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Co-Development Product in the Co-Development Territory. Within [***] days after
the ImmunoGen Opt-In Date, the Parties shall each nominate between two (2) and
five (5) (inclusive) representatives for membership on the JPC. Each Party may
change its representatives as it deems appropriate by written notice to the
other Party; provided, that neither Party may have fewer than two (2) or more
than five (5) representatives and that each representative is an officer or
employee of the applicable Party or its Affiliate who has sufficient experience
and responsibility within such Party to make decisions arising within the scope
of the JPC’s responsibilities. From time to time, the JPC may establish one or
more sub-teams comprised of qualified representatives of both Parties to
undertake specific responsibilities of the JPC, which sub-teams shall be
governed in the same manner and subject to the relevant requirements set forth
herein for the JPC. If any sub-team fails to reach unanimous agreement on a
matter before it within [***] days, the sub-team will refer the matter to the
JPC.

5.2.      Co-Chairs of Committee. Each Party shall nominate a co-chair of the
JPC. The co-chairpersons are responsible on an alternating basis for preparing
reasonably detailed written minutes of JPC meetings that reflect all material
decisions made at such meetings. The applicable co-chairperson will prepare
minutes of each JPC meeting and will send draft minutes to each representative
of the JPC for review and approval within [***] Business Days after the JPC
meeting. Such minutes shall be deemed approved unless one or more JPC
representatives object to the accuracy of such minutes within [***] Business
Days after receipt. The co-chairpersons shall have no additional powers or
rights beyond those held by other JPC representatives.

5.3.      Meetings. The JPC shall meet on a [***] basis or other schedule agreed
upon by the Parties, unless the Parties mutually agree in advance of any
scheduled meeting that there is no need for such meeting. In such instance, the
next JPC meeting shall also be scheduled as agreed upon by the Parties[***]
thirty (30) days’ notice to the other Party. The location of meetings of the JPC
shall alternate between ImmunoGen’s offices and Jazz’s offices, unless otherwise
agreed by the Parties. As agreed upon by the Parties, JPC meetings may be
face-to-face or may be conducted through teleconferences or videoconferences. In
addition to its JPC representatives, each Party may have other employees,
agents, or consultants attend such meetings to observe, present, and participate
in discussion, but such attendees will not have any decision-making capacity.
Each

-113-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

Party shall bear its own costs and expenses, including travel and lodging
expense, that may be incurred by JPC representatives or other attendees at JPC
meetings, as a result of such meetings hereunder.

5.4.      Decision Making. All decisions of the JPC will be made by consensus,
with each Party having collectively one (1) vote. If the JPC is unable to reach
consensus on any matter within its authority within [***] days following the
date such matter was first put to a vote, then the JPC will refer the matter to
[***] for resolution in accordance with [***] of the Agreement. For clarity,
[***] regarding the content, development and execution of the Product Plan,
including the aspects of the Product Plan set forth in Section 7.2 of this
Exhibit A, provided that such Product Plan includes the minimum participation
criteria set forth in Section 7.1((a)–(g)) of this Exhibit A.

5.5.      Responsibilities. The JPC shall be responsible for the following:

a)         reviewing and approving the Product Plan for the Co-Development
Product;

b)         coordinating and overseeing the Parties’ activities under the Product
Plan;

c)         providing a forum for each Party to provide feedback on the other
Party’s ongoing Commercialization activities of Co-Development Product;

d)         no less frequently than annually, reviewing and approving any
amendments to the Product Plan and evaluating any substantive departures by
either Party from the Product Plan;

e)         establishing and overseeing joint sub-teams to oversee particular
projects or activities within the purview of the JPC; and

f)          undertaking such other responsibilities as set forth in this
Agreement or as the Parties may mutually agree in writing.

6.         Co-Development Plan. All references to the “Development Plan” and
“Development Plan Budget” in the Agreement, unmodified by this Exhibit A, shall
apply solely with respect to the Jazz Territory. In addition, except with
respect to the definitions of “Development Plan” and

-114-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

“Development Plan Budget” in Section 1.30 and all references to the “Development
Plan” and “Development Plan Budget” in the Agreement be replaced with
“Development Plan or Co-Development Plan, as applicable” and “Development Plan
Budget or Co-Development Plan Budget, as applicable” respectively.

7.         Commercialization of Co-Development Product.

7.1.      Anything contained in Section 4.1.1 of the Agreement to the contrary
notwithstanding, within [***] days after the ImmunoGen Opt-In Date, Jazz shall
develop, in consultation with ImmunoGen, a proposed Product Plan for approval by
the JPC. The Product Plan proposed by Jazz and approved by the JPC shall:

a)         be consistent with the exercise of Commercially Reasonable Efforts to
Commercialize the Co-Development Product in the Co-Development Territory;

b)         allocate to Jazz primary control, authority and responsibility for
medical affairs activities and operationalizing the Product Plan and strategy
for Commercialization of the Co-Development Product in the Co-Development
Territory;

c)         allocate to ImmunoGen fifty percent (50%) of the Details, including
an equal number of sales representatives, in the Co-Development Territory for
the Co-Development Product, and fifty percent (50%) of the medical affairs
activities, including an equal number of medical science liaisons, in the
Co-Development Territory for the Co-Development Product (such Details and
medical affairs activities, collectively “Physician-Facing Activities”);

d)         specify a sale representative territory plan that (i) has been
reviewed by a Third Party consultant engaged by Jazz, and (ii) includes sales
representatives that are, as between the Parties, distributed in a balanced
manner across territories with roughly equivalent revenue opportunities and
geographical span;

e)         address field force strategy and detailing effort, size, structure,
incentive compensation, training, deployment as well as customer targets;

-115-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

f)          specify the aggregate number of individuals from both Parties who
will perform Physician-Facing Activities (such individuals, “Physician-Facing
FTEs”) by each commercial function;

g)         allocate to Jazz the development and modifications of materials to be
used for training of Physician-Facing FTEs;

h)         allocate to Jazz the establishment of the hiring profile of
Physician-Facing FTEs and the standards for performance (sales goals, incentive
compensation, etc.), operational metrics (number of calls and targets, etc.) and
measurement of business goals for all Physician-Facing Activities and
Physician-Facing FTEs;

i)          allow one (1) experienced employee of ImmunoGen to participate in
those portions of advisory board meetings that are specific to the
Co-Development Product;

j)          specify Jazz will provide, to one (1) manager at ImmunoGen who is
responsible for market access matters with respect to ImmunoGen’s own products,
a quarterly or more frequent update with respect to material meetings with
payers concerning the Co-Development Product and, to the extent any written
materials are prepared by Jazz following such material meeting, will provide
such materials to ImmunoGen; and

k)         comply with all Jazz policies, standard operating procedures, and
guidance, including with respect to compliance.

7.2.      ImmunoGen will be responsible for the performance of, and for hiring
and compensating, its Physician-Facing FTEs.

7.3.      Each Party will annually review whether the Physician-Facing FTEs
employed by the other Party satisfy the hiring profile, are properly trained
with respect to the Co-Development Product, and are adhering to the performance
standards. Each Party may provide comments to the other Party based on such
first Party’s annual review of the Physician-Facing FTEs and the other Party
shall consider such comments in good faith.

-116-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

7.4.      Following ImmunoGen’s exercise of the ImmunoGen Opt-In Right, the
Parties shall use Commercially Reasonable Efforts to Commercialize the
Co-Development Product in the Co-Development Territory in accordance with the
Product Plan. For purposes of clarity, Jazz shall retain sole authority and
responsibility for Commercialization of the Co-Development Product in the Jazz
Territory as set forth in Section 4.1.1.

7.5.      ImmunoGen’s employees and representatives will record all
Commercialization-related activities as reasonably directed by Jazz, which may
include recording such data in Jazz’s customer relationship management system in
the same manner, and following the same rules, as Jazz’s employees, recording
such data in a common customer relationship management system, or recording such
data in ImmunoGen’s customer relationship management system. The Parties will
cooperate to make sure that both Parties have reasonable access, which may be
indirect if required for compliance with terms of the vendor of the customer
relationship management system, to the Commercialization-related data recorded
by ImmunoGen’s sales representatives for purposes of reviewing sales force
performance of ImmunoGen’s Physician-Facing FTEs and, where such access is being
provided to ImmunoGen, directing and managing ImmunoGen’s Physician-Facing FTEs.
As between the Parties, Jazz shall own all Commercialization-related data
recorded by ImmunoGen’s sales representatives.

7.6.      All sales of the Co-Development Product will be booked by Jazz. If
ImmunoGen receives orders from customers for the Co-Development Product, it will
refer such orders to Jazz.

8.         Compliance. Each Party shall perform its obligations to Commercialize
the Co-Development Product in all material respects with all Applicable Laws.

9.         Commercialization Updates. Each Party shall keep the JPC reasonably
informed on the Commercialization activities performed by such Party in the
Co-Development Territory under this Agreement. Without limiting the foregoing,
at each regularly scheduled JPC meeting, each Party shall provide the JPC with a
summary report of the Commercialization or manufacturing activity performed by
it in the Co-Development Territory since the last JPC meeting and the results
thereof. The JPC shall discuss the progress and results of the Parties’
Commercialization or manufacturing activity in the Co-Development Territory and
each Party shall promptly respond to the other

-117-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Party’s reasonable questions or requests for additional information relating to
such Commercialization in the Co-Development Territory.

10.       Product Recalls. In the event any Regulatory Authority issues or
requests a recall or takes similar action with respect to the Co-Development
Product, or in the event either Party reasonably believes that an event,
incident or circumstance has occurred that may result in the need for such a
recall, the Party first becoming aware of such Regulatory Authority issuance or
request or having such reasonable belief shall promptly notify the other Party
thereof by telephone or email. Following such notification, Jazz shall decide
and have control of whether to conduct a recall or market withdrawal (except in
the event of a recall or market withdrawal mandated by a Regulatory Authority,
in which case it shall be required) or take such other corrective action in any
country and the manner in which any such recall, market withdrawal or corrective
action shall be conducted, provided that Jazz shall keep ImmunoGen informed
regarding any such recall, market withdrawal or corrective action as ImmunoGen
from time to time may reasonably request, but only to the extent Jazz is legally
permitted to do so. The expenses of any such recall, market withdrawal or
corrective action, including expenses of notification, destruction and return of
the Co-Development Product and any refund to customers of the amounts paid for
the Co-Development Product shall be Allowable Expenses (as defined in Exhibit
A-1).

11.       Confidential Information. All reports, updates, product complaints and
other information provided by the either Party to the other Party under this
Agreement (including under Section 3) with respect to the Commercialization of
the Co-Development Product in the Co-Development Territory, shall be considered
Confidential Information of both Parties, with both Parties being deemed the
Disclosing Party, subject to the terms of Section 8.

12.       Milestone Payment for Co-Development Product. Jazz shall remain
obligated to make the milestone payment set forth in Section 6.3(b) to ImmunoGen
in connection with the EMA’s approval of an MAA for the Co-Development Product
in the EU. For the avoidance of doubt, Jazz shall not make any milestone payment
under Section 6.3(a) for the Co-Development Product.

13.       Shared Commercialization Costs for Co-Development Product. Each Party
shall bear (and be entitled to) fifty percent (50%) of the Net Profit or Loss of
Commercialization activities

-118-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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for the Co-Development Product in the Co-Development Territory. The JPC shall
review quarterly reports of actual results of Commercialization of the
Co-Development Product in the Co-Development Territory submitted by the Parties
and will review and discuss potential discrepancies, reasonable forecasting, and
other finance and accounting matters, in accordance with Exhibit A-1, as
applicable, to determine the reimbursement due, if any, to a Party for each such
Calendar Quarter, and shall establish procedures with respect to the
reconciliation of Net Profit or Loss in the Co-Development Territory. Except to
the extent otherwise agreed by the Parties, such procedures shall include:

13.1.      Each Party shall provide the other with a non-binding estimate of its
Allowable Expenses incurred or to be incurred by such Party for each Calendar
Quarter [***] days before the end each Calendar Quarter. Within [***] days after
the end of each Calendar Quarter, each Party shall submit to the JPC a report
with regard to the estimated Net Sales (in the case of Jazz) and Allowable
Expenses (in the case of ImmunoGen and Jazz) incurred by each Party for the
Co-Development Product during such Calendar Quarter in the Co-Development
Territory in a manner sufficient to enable the other Party to comply with its
financial reporting requirements. Each Party shall submit a final report of such
Net Sales and Allowable Expenses within [***] days after the end of each
Calendar Quarter. Such report shall specify in reasonable detail all deductions
allowed in the calculation of such Net Sales and all expenses included in
Allowable Expenses. Following receipt of such report, each Party shall
reasonably cooperate to provide additional information as necessary to permit
calculation and reconciliation of Net Profit or Loss in the Co-Development
Territory for the applicable Calendar Quarter by the JPC. If reasonably
requested by the JPC, supporting documentation shall be promptly provided.

13.2.      Promptly following delivery of the reports from the Parties as
described above in Section 13.1 of this Exhibit A and in a reasonable time in
advance of applicable payments, the JPC shall develop a written report setting
forth in reasonable detail the calculation of Net Profit or Loss in the
Co-Development Territory for the applicable Calendar Quarter and amounts owed by
one Party to the other as necessary to accomplish the sharing of Net Profit or
Loss in the Co-Development Territory for the applicable Calendar Quarter in
accordance with this Section 13.2. The applicable Party shall pay the other
Party to reconcile Net Profit or Loss in the

-119-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Co-Development Territory within [***] days of receipt of such report by a Party
using the wire transfer provisions of Section 6.6.4 of the Agreement.

14.       Record Retention; Audit. Commencing on the ImmunoGen Opt-In Date, each
Party and its Affiliates and Sublicensees shall keep for at least [***] years
from the end of the Calendar Year to which they obtain complete and accurate
records of the Development Costs and Allowable Expenses received or incurred, by
such Party or its Affiliates or Sublicensees, as the case may be, of the
Co-Development Product, in sufficient detail to allow the accuracy of the
sharing of the Net Profit or Loss between the Parties. Each Party may inspect
such records of the other Party in accordance with Section 6.8.2 of the
Agreement.

15.       ImmunoGen Opt-Out Right. ImmunoGen shall have the option following
exercise of the ImmunoGen Opt-In Right, exercisable in its sole discretion, to
cease its obligations to Develop and Commercialize the Co-Development Product in
the Co-Development Territory (the “ImmunoGen Opt-Out Right”). ImmunoGen may
exercise the ImmunoGen Opt-Out Right at any time following the exercise of the
ImmunoGen Opt-In Right by providing [***] days’ notice of such opt-out to Jazz.
For purposes of clarity, ImmunoGen may not exercise the ImmunoGen Opt-In Right
under any Exclusive License Agreement following exercise of the ImmunoGen Opt-In
Right, regardless of whether ImmunoGen has exercised the ImmunoGen Opt-Out
Right. Following the effectiveness of ImmunoGen’s exercise of the ImmunoGen
Opt-Out Right, (i) ImmunoGen shall remain responsible for its share of all
Development Costs to the extent required by the Agreement, (ii) the
Co-Development Product will be deemed the Licensed Product subject to the terms
and conditions of the Agreement as if ImmunoGen had not exercised the ImmunoGen
Opt-Out Right, (iii) the Jazz Territory will be deemed to be worldwide, (iv) for
clarity, Jazz shall pay ImmunoGen the milestone set forth in Section 6.3(a) in
accordance with Section 6.3 if such milestone has not already been achieved by
the Parties prior to ImmunoGen’s exercise of the ImmunoGen Opt-Out Right, and
(v) for further clarity, Jazz shall pay ImmunoGen royalties on Net Sales of the
Licensed Product in the Jazz Territory in accordance with Section 6.4.

16.       Indemnification. ImmunoGen shall indemnify, defend and hold harmless
the Jazz Indemnitees, from and against all Losses incurred by or imposed upon
the Jazz Indemnitees, or any of them, as a direct result of any employment
related claim made by an ImmunoGen employee,

-120-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

sales representative, or medical science liaison, except in each case to the
extent any such claim or Losses result from a breach of this Agreement by Jazz,
or the negligence, recklessness or willful misconduct of Jazz or any of its
Affiliates, Sublicensees subcontractors, distributors or agents.

17.       Third Party Infringement. Anything in Section 9.4 of the Agreement to
the contrary notwithstanding, if an Infringement occurs in the Co-Development
Territory, all expenses incurred in any enforcement action pertaining to such
Infringement shall be considered Allowable Expenses and all Monies shall be
deemed Net Sales for the purpose of calculating Net Profits or Loss.

18.       Response to Biosimilar Applicants. Anything contained in Section 9.5
of the Agreement to the contrary notwithstanding, the Parties, acting through
the JPC, shall cooperate in responding to a Biosimilar Application for which the
Co-Development Product is the “reference product.”

19.       Term. Anything contained in Section 10.1 of the Agreement to the
contrary notwithstanding, the Term of the Agreement shall continue in the
Co-Development Territory until the Parties are no longer Developing or
Commercializing the Co-Development Product in the Co-Development Territory.

20.       Alternative to Termination.

20.1.      If Jazz elects to exercise its rights under Section 10.8, the
ImmunoGen Opt-Out Right will be deemed to have been exercised.

20.2.      If Jazz could have terminated the Agreement under Section 10.2.2 due
to a material breach of ImmunoGen for failing to comply with its funding
obligations under Section 6.2 of the Agreement or this Exhibit A, but Jazz
elects to exercise its rights under Section 10.8, then (a) ImmunoGen shall have
no further responsibility for the Development Costs, (b) the Co-Development
Product will be deemed the Licensed Product subject to the terms and conditions
of the Agreement as if ImmunoGen had not exercised the ImmunoGen Opt-Out Right
(subject to clauses (d) and (e) below), (c) the Jazz Territory will be deemed to
be worldwide, (d) Jazz shall pay ImmunoGen [***] the amount of the milestones
set forth in Section 6.3 if such milestones have not already been achieved prior
to Jazz’s election to exercise its rights under Section 10.8, and (e) Jazz shall
pay ImmunoGen royalties on Net Sales of the Licensed Product in the Jazz

-121-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

Territory at rate that is [***] the rates set forth in Section 6.4.1 (subject to
applicable reductions in Sections 6.4.2, 6.4.3, and 6.4.4).

20.3.      If Jazz could have terminated the Agreement under Section 10.2.2 due
to a material breach of ImmunoGen for any reason other than as set forth in
Section 20.2 of this Exhibit A, but Jazz elects to exercise its rights under
Section 10.8, then (a) ImmunoGen shall remain responsible for its share of the
Development Costs to the extent required by the Agreement, (b) the
Co-Development Product will be deemed the Licensed Product subject to the terms
and conditions of the Agreement as if ImmunoGen had not exercised the ImmunoGen
Opt-Out Right (subject to clauses (d) and (e) below), (c) the Jazz Territory
will be deemed to be worldwide, (d) Jazz shall pay ImmunoGen [***] the amount of
the milestones set forth in Section 6.3 if such milestones have not already been
achieved prior to Jazz’s election to exercise its rights under Section 10.8, and
(e) Jazz shall pay ImmunoGen royalties on Net Sales of the Licensed Product in
the Jazz Territory at rate that is [***] the rates set forth in Section 6.4.1
(subject to applicable reductions in Sections 6.4.2, 6.4.3, and 6.4.4).

21.       Change of Control. If ImmunoGen undergoes a Change of Control with an
entity that Jazz reasonably and in good faith views as a competitor to Jazz with
respect to the development, manufacture or commercialization of any of Jazz’s
products or product candidates, then the following terms shall apply:

21.1.      ImmunoGen and its representatives on the JPC shall [***]. [***] will
review the [***] to ensure that the [***] complies with the provisions of [***]
of this Exhibit A and all other terms and conditions of this Exhibit A and
[***]; and

21.2.      ImmunoGen shall [***]; provided, that [***] shall review [***] to
ensure that [***] is [***] in accordance with the terms of Exhibit A-1 and
[***].

-122-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

EXHIBIT A-1

FINANCIAL EXHIBIT

“Net Profit or Loss” in the Co-Development Territory shall be calculated in
accordance with this Exhibit A-1. Net Profit or Loss shall exclude all of the
payments set forth in Section 6 of the Agreement, all Development Costs, and any
other cost not specifically included in Allowable Expenses, including costs
attributable to general corporate activities, executive management, investor
relations, treasury services, business development, corporate government
relations, external financial reporting and other overhead activities. For the
sake of clarity, cost items included in components of Net Profit or Loss shall
not be double counted and shall not also be included in Development Costs.

Calculation of Net Profit or Loss

Net Profit or Loss in the Co-Development Territory shall be calculated for each
Calendar Quarter by determining the Net Sales of Co-Development Product in the
Co-Development Territory for such Calendar Quarter and subtracting the sum of
the Allowable Expenses (in each case, to the extent not already deducted from
Net Sales with respect to the Co-Development Product in the Co-Development
Territory) incurred with regard to Co-Development Product in the Co-Development
Territory during such Calendar Quarter. Notwithstanding the foregoing, on a
Calendar Year-to-date basis, Allowable Expenses shall [***]; provided,  however,
that Allowable Expenses [***] shall be included in the calculation of Net Profit
or Loss (i) if [***]; or (ii) to the extent such [***] allocated to be incurred
by such Party and its Affiliates in the applicable Calendar Year-to-date period
in accordance with the Product Budget for such Calendar Year; provided,
 however, that if any such [***] Allowable Expenses are [***] for a particular
Calendar Year-to-date period pursuant to the foregoing clause (ii), such [***]
Allowable Expenses shall be [***] and shall be [***] to the extent that they
satisfy clause (i) or (ii) in such subsequent [***].

Definitions

The following definitions shall apply for purposes of calculating Net Profit or
Loss in accordance with this Exhibit A-1.

-123-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

(1)        “Allowable Expenses” means, subject to the other provisions of this
Agreement and any Product Plan hereunder, the sum of the following costs and
expenses incurred following the ImmunoGen Opt-In Date by the Parties or their
Affiliates, in the course of the Commercialization of the Co-Development Product
in the Co-Development Territory in accordance with the Product Plan and this
Agreement during the applicable Calendar Quarter or the applicable Calendar
Year, in each case that are incurred in accordance with the Product Budget (each
as defined in the section listed in parentheses below):

a.         Product Out-of-Pocket Costs comprising upfront payments, milestones,
royalties, and any portion of other license fees or other payments arising out
of the manufacturing or Commercialization of the Co-Development Product and are
paid by a Party or its Affiliate to a Third Party pursuant to an agreement
entered into after the Option Agreement Effective Date wherein such Third Party
grants such Party or Affiliate a license to Patent Rights or Technology that are
owned or controlled by such Third Party and that are necessary or reasonably
useful to Develop, manufacture or Commercialize the Co-Development Product in
the Co-Development Territory; provided,  however, that if such Patent Rights or
Technology are [***] that such Party or its Affiliates is [***], then (i) with
respect to any such payment that [***], the [***] of such payment shall be [***]
in Product Out-of-Pocket Costs, (ii) with respect to any such payment that
[***], the [***] of such payment shall be [***] from Product Out-of-Pocket
Costs, and (iii) with respect to any other such payment (such as [***]), the
amount that qualifies as Product Out-of-Pocket Costs shall be [***] to [***]
(i.e. if the Patent Rights or Technology [***], then [***] of such payment shall
[***] Product Out-of-Pocket Costs);

b.         all Product Out-of-Pocket Costs and Product FTE Costs specifically
identifiable or reasonably allocable to the distribution of Co-Development
Product, including customer and wholesaler services, order entry, billing,
shipping, logistics, warehousing, inventory monitoring, product insurance,
freight not paid by customers, credit and collection and other like activities;

c.          Product Out-of-Pocket Costs and Product FTE Costs to conduct any
program to provide patients with the Co-Development Product prior to Regulatory
Approval in the Co-Development Territory, including treatment INDs/protocols,
named patient programs and

-124-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

compassionate use programs, including the costs of such programs following
Regulatory Approval;

d.         Product Out-of-Pocket Costs representing the annual fee paid to the
U.S. government as defined in the Affordable Care Act and similar taxes and
governmental fees in the United States, in each case to the extent directly
attributable or reasonably allocated to the Co-Development Product;

e.          Product Out-of-Pocket Costs and Product FTE Costs specifically
identifiable or reasonably allocable to the advertising, promotion and marketing
(including market and consumer research) of the Co-Development Product in the
Co-Development Territory, or to professional education with respect to the
Co-Development Product (and to the extent not performed by sales
representatives) in the Co-Development Territory;

f.          Product Out-of-Pocket Costs and Product FTE Costs approved by the
JPC and included in the Product Plan and the Product Budget that are not
otherwise included in any other Allowable Expense category, other than costs
associated with Development activities;

g.         Product Out-of-Pocket Costs and Product FTE Costs associated with
notification, retrieval and return of the Co-Development Product, destruction of
the returned Co-Development Product, replacement Co-Development Product and
distribution of the replacement Co-Development Product, in each case that are
incurred with respect to a recall conducted in accordance with Section 4.3.4 of
the Agreement; the Parties acknowledge that if the recall was not anticipated at
the time the Product Budget was established for a Calendar Year, then such
recall expenses shall not be included for determining whether the Party
conducting such recall has exceeded the amounts budgeted to be incurred by such
Party in such Calendar Year for Allowable Expenses. Notwithstanding the
foregoing, for clarity, such recall expenses that are Losses entitled to
indemnification under Sections 13.1.1(a) or (c) or 13.1.2(a) or ([d]) shall be
solely borne by the relevant Indemnifying Party, and shall not be shared
hereunder;

h.         Bad debts corresponding to gross invoiced sales for Co-Development
Products sold by Jazz or its Affiliates in the Co-Development Territory and
included in Net Sales

-125-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

of Co-Development Products but not collected and determined by Jazz or its
Affiliate to be uncollectible, provided that [***];

i.          Product Out-of-Pocket Costs and Product FTE Costs relating to grant
or maintenance of all permits, registrations, authorizations, licenses and
approvals (or waivers) required for the manufacture, Commercialization,
promotion, marketing, storage, import, export, transport, distribution, use,
offer for sale, sale or other commercialization of the Co-Development Product in
the Co-Development Territory, and personnel engaged in regulatory affairs
activities for the Co-Development Product in the Co-Development Territory,
including the filing and maintenance of such marketing authorizations in the
Co-Development Territory;

j.          Product Out-of-Pocket Costs and Product FTE Costs incurred with
respect to: sales representatives, sales managers, sales deployment planning,
customer targeting, payor and reimbursement activities, and hospital and managed
health care activities in each case specifically identifiable or reasonably
allocable to the Co-Development Product in the Co-Development Territory. The
Sales Representative FTEs and Sales Manager FTEs are calculated as described in
the definitions thereof. Costs for performance reporting and sales force
automation tools and hardware, such as laptops or tablets used to track
activity, are billable costs under this Agreement if below the capitalization
threshold or are to be replaced within [***];

k.         Product Out-of-Pocket Costs and Product FTE Costs incurred with
respect to medical affairs activities that are specifically identifiable or
reasonably allocable to the Co-Development Product in the Co-Development
Territory, including the cost of medical science liaisons, who shall be deemed
Product FTEs for purposes of determining Allowable Expenses;

l.          Product Out-of-Pocket Costs for the preparation, filing, prosecution
and maintenance of Product Patents, Patents claiming any Jazz Intellectual
Product, and trademarks and tradenames for the Co-Development Product in the
Co-Development Territory; and

m.        manufacturing (including conjugation, analytical testing, quality
assurance, packaging, and storage) costs for the Co-Development Product intended
or used for sale in the Co-Development Territory, which (i) to the extent the
Co-Development Product is manufactured by a Party or its Affiliates, shall
[***], and (ii) to the extent the Co-Development Product is

-126-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

manufactured by a Third Party in an arms-length transaction, the Product
Out-of-Pocket Costs paid to such Third Party for the manufacture of the
Co-Development Product (including manufacturing-related costs such as upfront
payments, start-up costs, amortization and depreciation costs, idle capacity
charges, cancellation fees, and minimum quantity fees) and the Product FTE Costs
incurred to manage or oversee such manufacture.

For clarity, it is understood that Allowable Expenses shall include only Product
Out-of-Pocket Costs and Product FTE Costs, and shall exclude Development Costs,
and that internal costs of a Party and its Affiliates shall be reimbursed only
as reflected in Product FTE Costs. For further clarity, ImmunoGen shall be
responsible for [***] of any costs payable by [***], following the [***], under
any [***] to use the [***] if such [***] to establish a [***]; provided that,
(A) [***] uses commercially reasonable efforts to [***], and (B) if such [***],
then ImmunoGen shall [***] with respect to the [***]. Notwithstanding anything
to the contrary in this Exhibit A-1, to the extent that any activity is
conducted (or a Product Out-of-Pocket Cost or Product FTE Cost is incurred) in
support of both the Co-Development Product and other products, services or
efforts of a Party, or is not solely attributable or reasonably allocable to the
Co-Development Product in the Co-Development Territory, then the Product
Out-of-Pocket Costs and Product FTE Costs thereof shall be included in Allowable
Expenses only to the extent included in the Product Budget, or included under
this Financial Exhibit. In connection with the JPC’s review of a proposed
Product Budget, upon the request of either Party, the JPC shall review the
methodology used to allocate to the Allowable Expenses, the Product FTE Costs
and Product Out-of-Pocket Costs of such combined activity, and if the JPC does
not approve such methodology, the matter shall be resolved by the JSC.

(2)        “Product FTE” means the equivalent of an individual engaged full time
for one (1) Calendar Year (consisting of a total of [***] hours per year)
directly related to Commercialization (and related manufacturing) activities
under the Product Plan, or any prorated portion thereof. [***] who works [***]
hours per year [***] shall be [***].

(3)        “Product FTE Costs” means the product of the number of Product FTEs
times the Product FTE Rate.

-127-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

(4)        “Product FTE Rate” means[***]and for each [***], the result obtained
by [***] by the [***] where [***] is [***], the [***] is the [***] for the [***]
of the [***] and the [***] for the [***] the [***], and the [***] is the [***]
for the [***] the [***]; provided,  however, that in no event shall the Product
FTE Rate for any [***] be less than the [***]. For the avoidance of doubt, such
rate includes all travel expenses. The reported actual time spent shall be
substantiated by a time tracking system consistently applied.

General Principles.

Allowable Expenses shall initially be borne by the Party incurring the cost or
expense, subject to reimbursement as provided herein.

Each Party shall provide financial statements in such reporting format as the
JPC may establish for use by the Parties.

All calculations to be made pursuant to this Financial Exhibit shall be made in
accordance with (i) the applicable definitions and terms set forth in this
Financial Exhibit and in the Agreement in a manner consistent with the
methodologies used for the Product Budget (first priority), (ii) the specific
accounting policies as may be established by the JPC (second priority) and (iii)
applicable accounting standards, consistently applied (third priority). All
undefined terms shall be construed in accordance with applicable accounting
standards, consistently applied, but only to the extent consistent with the
other express terms and definitions in this Financial Exhibit and the Agreement
and specific accounting policies established by the JPC.

For clarity, income and withholding taxes imposed on either of the Parties or
their Affiliates hereunder will not be included in the calculation of Net Profit
or Loss, except to the extent that the withholding taxes are paid by a Party or
its Affiliates for the benefit of a Third Party, as a result of the sale of the
Co-Development Product in the Co-Development Territory, and such Party or its
Affiliate is not permitted to deduct the taxes paid from the amount it would
otherwise owe such Third Party.

Losses from Third Party Claims; Exclusion of Costs Due to Breach or Subject to
Indemnification under Section 13.1.1 or 13.1.2 of the Agreement

-128-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

The Parties agree that Losses that arise out of the performance, in good faith,
of Development, manufacture, Commercialization or other exploitation of
Co-Development Product in or for the Co-Development Territory following the
Effective Date in accordance with the Agreement will be charged to the Net
Profit or Loss; provided, that Net Profit or Loss will not include Losses or
costs of a Party or its Affiliate that are subject to indemnification by such
Party pursuant to Section 13.1.1(a) or (c) or Section 13.1.2(a) or ([d]) of the
Agreement (for clarity, if a Third Party makes a Third Party Claim directly
against Jazz (or any of its Affiliates) or ImmunoGen (or any of its Affiliates),
respectively, that would otherwise be indemnified by Jazz pursuant to Section
13.1.1(a) or (c) or by ImmunoGen pursuant to Section 13.1.2(a) or ([d]), if such
Third Party Claim had been made against the other Party (or any of its
Affiliates), then Losses incurred by Jazz or ImmunoGen in connection with such
direct Third Party Claim will not be included in the calculation of Net Profit
or Loss).

Reconciliations

The JPC will coordinate to resolve any differences in or disputes regarding the
calculation of Net Profit or Loss, or any component thereof. If the JPC is
unable to resolve any such difference or dispute, the matter shall be resolved
by the JSC.

 

 

 

 

 

SCHEDULE C

PRESS RELEASE

See attached.

 

 

-129-

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

 

Picture 1 [imgn20170930ex101bd9885001.jpg]

Picture 2 [imgn20170930ex101bd9885002.jpg]

 

 

Jazz Pharmaceuticals and ImmunoGen, Inc. Announce a
Strategic Collaboration and Option Agreement to Develop and Commercialize
Antibody-Drug Conjugate Products

Strengthens Jazz hematology/oncology portfolio with options for innovative
development
candidates IMGN779 and IMGN632

ImmunoGen to receive a $75 million upfront payment, up to $100 million in
research support,
a co-commercialization option, and potential future opt-in fees, milestones and
royalties

ImmunoGen conference call to be held today at 8:00 AM EDT; Jazz conference call
to be held
today at 4:30 PM EDT

DUBLIN and Waltham, Mass. August 29, 2017 -- Jazz Pharmaceuticals plc (Nasdaq:
JAZZ) and ImmunoGen, Inc. (Nasdaq: IMGN) today announced that the companies have
entered into a collaboration and option agreement granting Jazz Pharmaceuticals
exclusive, worldwide rights to opt into development and commercialization of two
early-stage, hematology-related antibody-drug conjugate (ADC) programs, as well
as an additional program to be designated during the term of the agreement.  The
programs covered under the agreement include IMGN779, a CD33-targeted ADC for
the treatment of acute myeloid leukemia (AML) in Phase 1 testing, and IMGN632, a
CD123-targeted ADC for hematological malignancies expected to enter clinical
testing before the end of the year. 

Under the terms of the agreement, ImmunoGen will be responsible for the
development of the three ADC programs prior to any potential opt-in by
Jazz.  Following any opt-in, Jazz would be responsible for any further
development as well as for potential regulatory submissions and
commercialization.

As part of the agreement, Jazz will pay ImmunoGen an upfront payment of $75
million.  Additionally, Jazz will pay ImmunoGen up to $100 million in
development funding over seven years to support the three ADC programs.  For
each program, Jazz may exercise its opt-in right at any time prior to a pivotal
study or any time prior to a biologics license application (BLA) upon payment of
an option exercise fee of mid-double digit millions or low triple digit
millions, respectively.  For each program to which Jazz elects to opt-in,
ImmunoGen would be eligible to receive milestone payments based on receiving
regulatory approval of the applicable product, plus tiered royalties as a
percentage of commercial sales by Jazz, which depending upon sales levels and
the stage of development at the time of opt-in, range from mid- to high single
digits in the lowest tier to low 10’s to low 20’s in the highest tier.  After
opt-in, Jazz and ImmunoGen would share costs associated with developing and
obtaining regulatory approvals of the applicable product in the United States
(U.S.) and the European Union.  ImmunoGen has the right to co-commercialize in
the U.S. one product (or two products, under certain limited circumstances) with
U.S. profit sharing in lieu of Jazz’s payment of the U.S. milestone

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

 

and royalties to ImmunoGen.

“We are pleased to enter into this collaboration with ImmunoGen, a well-known
leader in the field of ADC technology, with demonstrated success in creating ADC
molecules, including the only FDA-approved ADC product to treat metastatic
breast cancer.  This investment supports our long-term commitment to expand our
hematology/oncology portfolio with the potential addition of multiple innovative
antibody drug conjugates,” said Bruce Cozadd, chairman and chief executive
officer of Jazz Pharmaceuticals.  “We look forward to the advancement of these
ADC programs and the potential synergy of these compounds with our current
products and pipeline, as new therapeutic options for cancer patients are
urgently needed.”

“This strategic partnership with Jazz significantly advances our goal of
accelerating the development of our early-stage novel ADC assets.  This deal
joins us with a global partner, provides us with substantial funding to support
these programs, and preserves the right to co-commercialize one of these
assets,” said Mark Enyedy, president and chief executive officer of
ImmunoGen.  “Jazz has demonstrated the ability to bring innovative compounds to
patients and will make an ideal partner to help develop and commercialize our
novel ADC assets targeting AML, and more broadly, in the area of
hematology/oncology.  In addition, this partnership significantly strengthens
our financial position and moves us closer to delivering upon our mission of
bringing ADC therapies to patients.”

IMGN779 is a novel ADC that combines a high-affinity, humanized anti-CD33
antibody, a cleavable disulfide linker, and one of ImmunoGen’s novel
indolino-benzodiazepine payloads, called IGNs, which alkylate DNA without
crosslinking, resulting in potent preclinical anti-leukemia activity with
relative sparing of normal hematopoietic progenitor cells1,2.  IMGN779 is in
Phase 1 clinical testing for the treatment of AML.  IMGN632 is a preclinical
stage humanized anti-CD123 antibody-based ADC that is a potential treatment for
AML, blastic plasmacytoid dendritic cell neoplasm (BPDCN), myelodysplastic
syndrome, B-cell acute lymphocytic leukemia, and other CD123-positive
malignancies.  IMGN632 uses a novel payload, linker, and antibody technology and
in AML xenograft models has demonstrated a large therapeutic index3.  ImmunoGen
expects to file an investigational new drug application (IND) for IMGN632 this
quarter and enroll the first patient in a Phase 1 study before the end of the
year.

Jazz Pharmaceuticals Conference Call Details

Jazz Pharmaceuticals will host a conference call and live audio webcast today at
4:30 p.m. EDT/9:30 p.m. IST to discuss this transaction.  Interested parties may
access the live audio webcast and slide presentation via the Investors section
of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.  Please
connect to the website prior to the start of the conference call to ensure
adequate time for any software downloads that may be necessary to listen to the
webcast.  A replay of the webcast will be archived on the website for one week.

Jazz audio webcast/conference call:

U.S. Dial-In Number: +1 855 353 7924

International Dial-In Number: +1 503 343 6056

Passcode:  76457218

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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

 

 

 

A replay of the conference call will be available through September 5, 2017 and
accessible through one of the following telephone numbers, using the passcode
below:

Replay U.S. Dial-In Number: +1 855 859 2056

Replay International Dial-In Number: +1 404 537 3406

Passcode:  76457218

ImmunoGen Conference Call Details

ImmunoGen will host a conference call and live audio webcast today at 8am EDT to
discuss this transaction. Interested parties may access the live audio webcast
via the Investors section of the ImmunoGen website at www.immunogen.com.  A
replay of the webcast will be archived on the website for approximately one
week.

ImmunoGen audio webcast/conference call:

Dial-In Number: +1 719-457-2607

Passcode:  8332814

About Jazz Pharmaceuticals

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is an international biopharmaceutical
company focused on improving patients’ lives by identifying, developing and
commercializing meaningful products that address unmet medical needs.  The
company has a diverse portfolio of products and product candidates, with a focus
in the areas of sleep and hematology/oncology. In these areas, Jazz
Pharmaceuticals markets Xyrem® (sodium oxybate) oral solution, Erwinaze®
(asparaginase Erwinia chrysanthemi), Defitelio® (defibrotide sodium) and Vyxeos™
(daunorubicin and cytarabine) liposome for injection in the U.S. and markets
Erwinase® and Defitelio® (defibrotide) in countries outside the U.S.  For more
information, please visit www.jazzpharmaceuticals.com.

About ImmunoGen

ImmunoGen is a clinical-stage biotechnology company that develops targeted
cancer therapeutics using its proprietary antibody-drug conjugate (ADC)
technology. ImmunoGen's lead product candidate, mirvetuximab soravtansine, is in
a Phase 3 trial for FRα-positive platinum-resistant ovarian cancer, and is in
Phase 1b/2 testing in combination regimens for earlier-stage
disease.  ImmunoGen's ADC technology is used in Roche's marketed product,
Kadcyla®, in other clinical-stage ImmunoGen product candidates, and in programs
in development by Amgen, Bayer, Biotest, CytomX, Debiopharm, Lilly, Novartis,
Sanofi and Takeda.  More information about the Company can be found at
www.immunogen.com.  

Jazz Pharmaceuticals “Safe Harbor” Statement under the Private Securities
Litigation Reform Act of 1995

This press release contains forward-looking statements, including, but not
limited to, statements related to the potential exercise by Jazz Pharmaceuticals
of its opt-in rights with respect to certain early-stage product
candidates covered by the collaboration and option agreement, the potential
benefits of such product candidates and related development and regulatory
activities, potential future payments to ImmunoGen by Jazz Pharmaceuticals, the
potential exercise by ImmunoGen of its

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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co-commercialization rights with respect to such product candidates, Jazz
Pharmaceuticals’ commitment to expand its hematology/oncology portfolio with the
potential addition of multiple innovative antibody drug conjugates, the
advancement of the ADC program covered by the collaboration and option agreement
and the potential synergy of these compounds with Jazz Pharmaceuticals’ current
products and pipeline, the timing of such events and activities, and other
statements that are not historical facts.  These forward-looking statements are
based on the company's current plans, objectives, estimates, expectations and
intentions and inherently involve significant risks and uncertainties.  Actual
results and the timing of events could differ materially from those anticipated
in such forward-looking statements as a result of these risks and uncertainties,
which include, without limitation, risks and uncertainties associated with:
whether Jazz Pharmaceuticals will exercise its opt-in rights with respect to
certain early-stage product candidates covered by the collaboration and option
agreement, and, if exercised, Jazz Pharmaceuticals' ability to achieve the
expected benefits (commercial or otherwise) from the acquisition of rights to
such product candidates; whether ImmunoGen will exercise its
co-commercialization rights with respect to such product candidates;
pharmaceutical product development and clinical success thereof; the regulatory
approval process; and effectively commercializing any product candidates
acquired by Jazz Pharmaceuticals under the collaboration and option agreement;
and other risks and uncertainties affecting the company and its development
programs, including those described from time to time under the caption "Risk
Factors" and elsewhere in Jazz Pharmaceuticals plc's Securities and Exchange
Commission filings and reports (Commission File No. 001-33500), including the
company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2017 and
future filings and reports by the company.  Other risks and uncertainties of
which the company is not currently aware may also affect the company's
forward-looking statements and may cause actual results and the timing of events
to differ materially from those anticipated.  The forward-looking statements
herein are made only as of the date hereof or as of the dates indicated in the
forward-looking statements, even if they are subsequently made available by the
company on its website or otherwise.  The company undertakes no obligation to
update or supplement any forward-looking statements to reflect actual results,
new information, future events, changes in its expectations or other
circumstances that exist after the date as of which the forward-looking
statements were made.

ImmunoGen “Safe Harbor” Statement under the Private Securities Litigation Reform
Act of 1995

This press release includes forward-looking statements.  For these statements,
ImmunoGen claims the protection of the safe harbor for forward-looking
statements provided by the Private Securities Litigation Reform Act of 1995.  It
should be noted that there are risks and uncertainties related to the
development of novel anticancer products, including IMGN779 and IMGN632,
including risks relating related to preclinical and clinical studies, their
timing and results.  A review of these risks can be found in ImmunoGen's
Transition Report on Form 10-K for the six-month period ended December 31,
2016 and other reports filed with the Securities and Exchange Commission.

References:

1  S. Adams et al, Abstract P526, Presented at the 22nd Congress of the European
Hematology Association, June 22-25, 2017.

2  Y. Kotvun et al. (2016) Blood 128:768.

3  S. Adams et al, Abstract 2832, Presented at the American Society of
Hematology, December 3-6,

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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2016.

 

 

 

Jazz Pharmaceuticals Contacts:

 

Investors: 
Kathee Littrell
Vice President, Investor Relations
Ireland, +353 1 634 7887
U.S., +1 650 496 2717

Media:
Jacqueline Kirby
Vice President, Corporate Affairs & Government Relations
Ireland, +353 1 697 2141
U.S., +1 215 867 4910

 

 

ImmunoGen Contacts:

 

Investors:

Sarah Kiely,

Director, Investor Relations

781-895-0600

sarah.kiely@immunogen.com

Media:

Courtney O'Konek,

Director, Corporate Communications

781-895-0158

courtney.okonek@immunogen.com

 

or

 

FTI Consulting, Inc.

Robert Stanislaro, 212-850-5657

robert.stanislaro@fticonsulting.com

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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SCHEDULE D

TERM SHEET FOR COMBINATION TRIAL AGREEMENT

 

 

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1.    [***]

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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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Portions of this Exhibit, indicated by the mark “[***],” were omitted and have
been filed separately with the Securities and Exchange Commission pursuant to
the Registrant’s application requesting confidential treatment pursuant to Rule
24b-2 of the Securities Exchange Act of 1934, as amended.

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