COLLABORATION AND OPTION AGREEMENT between IMMUNOGEN, INC. and JAZZ PHARMACEUTICALS IRELAND LIMITED dated August 28, 2017
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 xxxx “[***],” 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
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Page |
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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 |
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Portions of this Exhibit, indicated by the xxxx “[***],” 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
(continued)
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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 |
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Portions of this Exhibit, indicated by the xxxx “[***],” 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
(continued)
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Page |
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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 |
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Portions of this Exhibit, indicated by the xxxx “[***],” 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.
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 000 Xxxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxxxxxx 00000, and Jazz Pharmaceuticals Ireland Limited, a corporation organized under the laws of Ireland (“Jazz”), with its principal place of business at Xxxxxxxx Xxxxxxxx, Xxxxxxxx Xxxx, Xxxxxx 0, Xxxxxxx. 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 xxxx “[***],” 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.
1.1 “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
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Portions of this Exhibit, indicated by the xxxx “[***],” 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.
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)
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Portions of this Exhibit, indicated by the xxxx “[***],” 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.
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
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Portions of this Exhibit, indicated by the xxxx “[***],” 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.
3.5), [***] 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
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Portions of this Exhibit, indicated by the xxxx “[***],” 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.
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 [***].
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Portions of this Exhibit, indicated by the xxxx “[***],” 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.
1.28 “[***]” 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.
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Portions of this Exhibit, indicated by the xxxx “[***],” 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.
1.34 “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
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Portions of this Exhibit, indicated by the xxxx “[***],” 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.
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 [***].
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Portions of this Exhibit, indicated by the xxxx “[***],” 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.
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Portions of this Exhibit, indicated by the xxxx “[***],” 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.
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Portions of this Exhibit, indicated by the xxxx “[***],” 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
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Portions of this Exhibit, indicated by the xxxx “[***],” 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
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Portions of this Exhibit, indicated by the xxxx “[***],” 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
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Portions of this Exhibit, indicated by the xxxx “[***],” 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
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Portions of this Exhibit, indicated by the xxxx “[***],” 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
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Portions of this Exhibit, indicated by the xxxx “[***],” 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).
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Portions of this Exhibit, indicated by the xxxx “[***],” 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
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Portions of this Exhibit, indicated by the xxxx “[***],” 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 XXXx 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
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Portions of this Exhibit, indicated by the xxxx “[***],” 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.
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Portions of this Exhibit, indicated by the xxxx “[***],” 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.
1.91 “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 |
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Portions of this Exhibit, indicated by the xxxx “[***],” 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 |
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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 |
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Portions of this Exhibit, indicated by the xxxx “[***],” 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;
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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
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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:
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(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.
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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:
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(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.
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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 .
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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
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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:
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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 [***].
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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
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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
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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.
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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.
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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
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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 [***]
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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.
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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.
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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
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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 [***]
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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;
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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
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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
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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
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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”). [***]
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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.
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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
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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
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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
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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.
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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
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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
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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
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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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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
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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
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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).
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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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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
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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.
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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
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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: [***].
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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
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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
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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
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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
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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;
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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
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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
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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.
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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
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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.
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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;
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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 [***];
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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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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
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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 Xxxxxxx Xxx 0000 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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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
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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
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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
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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.
000 Xxxxxx Xxxxxx
Xxxxxxx, XX 00000
Xxxxxx Xxxxxx of America
Attn: Vice President, Business Development
with a copy to: ImmunoGen, Inc.
000 Xxxxxx Xxxxxx
Xxxxxxx, XX 00000
Xxxxxx Xxxxxx of America
Attn: Legal Department
If to Jazz: Jazz Pharmaceuticals Ireland Limited
Xxxxxxxx Xxxxxxxx
Xxxxxxxx Xxxx
Xxxxxx 0
Xxxxxxx
Attn: Secretary
with a copy to: Jazz Pharmaceuticals
0000 Xxxxxx Xxxxx
Xxxx Xxxx, Xxxxxxxxxx 00000
Xxxxxx Xxxxxx of America
Attn: General Counsel
with a copy to: Xxxxxx LLP
0000 Xxxxxxx Xxxxxx
Xxxx Xxxx, XX 00000-0000
Xxxxxx Xxxxxx of America
Attn: Xxxxx X. Xxxxxxx, 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
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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
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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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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
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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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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
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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
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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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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives.
IMMUNOGEN, INC. |
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JAZZ PHARMACEUTICALS |
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IRELAND LIMITED |
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By: |
/s/ Xxxxx Xxxxxxxx |
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By: |
/s/ Xxxx Xxxxxx |
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Name: |
Xxxxx Xxxxxxxx |
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Name: |
Xxxx Xxxxxx |
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Title: |
Vice President, Business Development |
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Title: |
Director |
Portions of this Exhibit, indicated by the xxxx “[***],” 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 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 [***].
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SCHEDULE B
FORM OF LICENSE AGREEMENT
See attached.
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Portions of this Exhibit, indicated by the xxxx “[***],” 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 xxxx “[***],” 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 |
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1. |
DEFINITIONS |
1 | |
2. |
GRANT OF RIGHTS |
30 | |
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2.1. |
License Grants |
30 |
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2.2. |
Retained Rights |
31 |
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2.3. |
Covenants |
31 |
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2.4. |
No Implied Licenses |
31 |
3. |
Governance |
31 | |
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3.1. |
Alliance Management |
31 |
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3.2. |
Joint Steering Committee |
32 |
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3.3. |
Joint Development Committee |
34 |
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3.4. |
Joint Patent Committee |
36 |
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3.5. |
One Committee |
37 |
4. |
Development and Commercialization |
37 | |
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4.1. |
Development and Commercialization |
37 |
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4.2. |
Safety; Adverse Event Reporting |
39 |
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4.3. |
Updates and Reports; Notification of Milestones; Product Recalls |
39 |
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4.4. |
Use of ImmunoGen Proprietary Materials |
41 |
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4.5. |
Unauthorized Use of ImmunoGen’s Proprietary Materials and Confidential Information |
41 |
5. |
SUPPLY AND MANUFACTURING OBLIGATIONS; SERVICES |
44 | |
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5.1. |
Manufacturing Responsibilities |
44 |
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5.2. |
Technology Transfers |
44 |
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5.3. |
Interim Supply; CMO Agreements |
45 |
6. |
FINANCIAL TERMS |
46 | |
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6.1. |
Upfront Payment |
46 |
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6.2. |
Development Costs |
46 |
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6.3. |
Milestone Payments for Licensed Product |
50 |
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6.4. |
Payment of Royalties; Royalty Rates; Accounting for Royalties and Records |
51 |
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6.5. |
Royalty Term |
54 |
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6.6. |
Payment Terms |
55 |
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6.7. |
Overdue Payments |
56 |
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6.8. |
Records Retention; Audit |
57 |
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6.9. |
Financial Statements |
58 |
7. |
CO-DEVELOPMENT OPT-IN RIGHT |
60 | |
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7.1. |
ImmunoGen Opt-In Right |
60 |
8. |
TREATMENT OF CONFIDENTIAL INFORMATION |
60 | |
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8.1. |
Confidentiality |
60 |
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8.2. |
Publicity |
62 |
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8.3. |
Publications and Presentations |
63 |
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8.4. |
Integration |
64 |
9. |
FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS |
65 | |
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9.1. |