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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
DATED: MAY 4, 2000
BRITISH BIOTECH PHARMACEUTICALS LIMITED
AND
IMMUNOGEN, INC
DEVELOPMENT, COMMERCIALIZATION
AND LICENSE AGREEMENT
RE: huN901-DM1
British Biotech Pharmaceuticals Limited
Xxxxxxxxxx Xxxx
Xxxxxx XX0 0XX
Tel: 00000 000000
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
INDEX OF CONTENTS
1. Definitions..............................................................
A COMMENCEMENT PROVISIONS
2. Grant and acceptance of rights...........................................
3. Sub-licenses.............................................................
4. Other Countries..........................................................
5. Provision of Technical Information and assistance........................
6. Term.....................................................................
7. Formation of Collaboration Committee.....................................
B ANCILLARY PROVISIONS
8. [*]......................................................................
9. [*]......................................................................
9A [*]......................................................................
C COMPENSATION PROVISIONS
10. Compensation.............................................................
11. Royalties in respect of sales of Licensed Compound and/or Product........
12. Accounting and Payment...................................................
D CLINICAL DEVELOPMENT PROVISIONS
12A Preparation and filing of IND............................................
13. Development Plan.........................................................
14. Pre-Clinical Studies and Pharmacokinetic Studies.........................
15. Agreed Clinical Studies..................................................
16. Clinical Development for other indications
17. Investigators' meetings..................................................
18. Adverse Event Reporting..................................................
E MANUFACTURING AND SUPPLY PROVISIONS
19. Product Specification....................................................
20. Transfer of Manufacturing Information....................................
21. Development obligations of ImmunoGen.....................................
22. Supply for Clinical Development purposes.................................
23. Non-conforming clinical supplies.........................................
24. Commercial Manufacture and Supply of Product.............................
25. Contract Manufacturing...................................................
26. Retention of records.....................................................
27. ImmunoGen's inability to supply..........................................
28. Regulatory compliance and reporting......................................
29. Audit rights of BB.......................................................
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F COMMERCIALIZATION PROVISIONS
30. BB's Diligence Obligations...............................................
31. Obtaining Regulatory Approval in the Territory...........................
32. Regulatory Approvals outside the Territory...............................
33. Marketing and sale of Product............................................
34. Trade marks..............................................................
G PATENT PROVISIONS
35. Patent Prosecution and Maintenance.......................................
36. Inventions of BB.........................................................
37. Infringement and Invalidity Proceedings..................................
38. Third Party Infringement Proceedings.....................................
39. Miscellaneous Provisions.................................................
40. Effect of Interim or Final Restraining Orders or Injunctions on Agreement
41. Further Third Party Licenses.............................................
42. Compulsory Licenses......................................................
43. Direct Affiliate Licenses................................................
H TERMINATION PROVISIONS
44. BB's Rights to Terminate.................................................
45. ImmunoGen's Rights to Terminate..........................................
46. General rights of termination by either party............................
47. Effect of Termination....................................................
I PUBLICITY AND PUBLICATIONS PROVISIONS
48. Publicity................................................................
49. Publications.............................................................
J DISPUTE PROVISIONS
50. Governing Law and Jurisdiction...........................................
51. Dispute Resolution.......................................................
52. Legal Proceedings........................................................
K CONFIDENTIALITY, NON-SOLICITATION AND STANDSTILL PROVISIONS
53. Confidentiality..........................................................
54. Additional provision of information by ImmunoGen.........................
55. Non-solicitation of Staff................................................
56. Standstill Provisions....................................................
L WARRANTY AND INDEMNITY PROVISIONS
57. Representations and Warranties of each Party.............................
58. Representations and Warranties of ImmunoGen..............................
59. Non-compete..............................................................
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60. No Inconsistent Agreements...............................................
61. Representation by Legal Counsel..........................................
62. Indemnification..........................................................
M GENERAL PROVISIONS
63. Bankruptcy protection....................................................
64. Notices..................................................................
65. Force Majeure............................................................
66. Assignments..............................................................
67. Severability.............................................................
68. Waiver...................................................................
69. VAT......................................................................
70. Costs of Preparation.....................................................
71. Government Consent.......................................................
72. Independent Discoveries by BB............................................
73. Independent Relationship.................................................
74. Counterparts.............................................................
75. Recording................................................................
76. Further Actions..........................................................
77. Entire Agreement.........................................................
Schedule 1 Part 1 - Chemical Structure of huN901..........................
Part 2 - Chemical Structure of Licensed Compound...............
Schedule 2 Patents........................................................
Schedule 3 Development Plan...............................................
Schedule 4 Principal terms of Commercial Supply Agreement.................
Schedule 5 List of Third Party Licenses...................................
Schedule 6 Registration in the RoW based on an EU/USA Development Plan....
Schedule 7 CMC Development activities for huN901-DM1......................
Schedule 8 Calculation of COGS............................................
Schedule 9 Schedule of costs for bioanalytical work to be conducted by
ImmunoGen under Clause 14.2....................................
Schedule 10 Further Third Party licenses...................................
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THIS AGREEMENT is made the 4th day of May, 2000
BETWEEN
BRITISH BIOTECH PHARMACEUTICALS LIMITED an English company (registered number
1985479) whose registered office is at Xxxxxxxxxx Xxxx, Xxxxxx XX0 0XX, Xxxxxxx
("BB")
and
IMMUNOGEN, INC. a corporation organized and existing under the laws of the
Commonwealth of Massachusetts, USA and having its principal place of business at
000 Xxxxxxxxxx Xxxxxxx, Xxxxxxx, Xxxxxxxxxxxxx, 00000 XXX ("ImmunoGen")
WHEREAS
(A) ImmunoGen owns and controls proprietary rights, titles and interest in
the Patents, the Technical Information and the Manufacturing
Information relating to a conjugated antibody known as huN901-DM1 and
the components thereof.
(B) ImmunoGen has conducted a number of pre-clinical studies evaluating
huN901-DM1 as an anti-cancer agent in the treatment of small cell lung
cancer and the results of such studies have shown huN901-DM1 to be
effective in treating models of small cell lung cancer at non-toxic
doses.
(C) The parties wish to enter into a development and commercialization
collaboration whereby, inter alia:
(1) BB shall be responsible for the clinical development of
huN901-DM1 in the treatment of small cell lung cancer in the
Territory and the USA together with the right to develop
huN901-DM1 for other indications within the Field in the
Territory;
(2) ImmunoGen shall retain responsibility for all pre-clinical
activities and the manufacture and supply of huN901-DM1 for
clinical development, registration and commercialization
purposes both inside and outside the Territory;
(3) BB shall be responsible for filing and obtaining Regulatory
Approvals in the Territory and ImmunoGen shall be responsible
for filing and obtaining Regulatory Approvals outside the
Territory; and
(4) BB shall have the right to market and sell products containing
huN901-DM1 in the Territory and ImmunoGen shall have the right
to market and sell products containing huN901-DM1 outside the
Territory.
subject to and in accordance with the terms and conditions set out
below.
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NOW THEREFORE IT IS AGREED AS FOLLOWS:
1 DEFINITIONS
1.1 "Accounting Period" means any period of three (3) months ending on 31st
January, 30th April, 31st July or 31st October (each an "Accounting
Date") in any year. The first Accounting Period in a particular country
in the Territory shall commence on the day of the first Launch in such
country and shall terminate on the next Accounting Date at least three
(3) months thereafter.
1.2 "Affiliate" means any Entity which (directly or indirectly) owns, is
owned by or is under common ownership with a party to this Agreement or
any Entity actually controlled by, controlling or under common control
with a party to this Agreement. For the purposes of this definition
"ownership" or "control" shall mean the possession (directly or
indirectly) of more than fifty per cent (50%) of voting stock and/or
the ability to direct the business affairs of another Entity.
1.3 "Agreed Clinical Study" means any study or studies in humans more
particularly detailed in the Development Plan that will be undertaken
by BB in order to obtain Regulatory Approval to market and sell Product
in the Territory or the USA and to assist in obtaining Regulatory
Approvals in other parts of the world for use in the treatment of the
Primary Indication.
1.4 "BB Improvements" means any inventions, discoveries, improvements or
enhancements relating to Licensed Compound or Product, whether
patented, patentable or non-patentable, conceived or first reduced to
practice by BB during the term of this Agreement by or on behalf of BB
but independent of any patents, patent applications, technical
information or know-how (including ImmunoGen Improvements) of ImmunoGen
and in respect of which BB is free to disclose and grant licenses to
ImmunoGen.
1.5 "BLA" means a Biologics License Application or a New Drug Application
("NDA") (whichever is applicable to Product) or equivalent filed with
the FDA, a Marketing Authorization Application filed with the EMEA or a
Marketing Authorization Application or a Product License Application or
equivalent filed in any one or more of the countries within the
Territory.
1.6 "Clinical Development" means all activities subsequent to the Effective
Date relating to human clinical trials specifically required to support
Regulatory Approvals to market and sell Product in the USA or the
Territory. Clinical Development specifically excludes Manufacture, CMC
Development and any and all activities relating to Pre-Clinical
Studies, which shall be the responsibility of ImmunoGen.
1.7 "Clinical Study" means any study or studies in humans that will be
undertaken in order to obtain or to assist in obtaining Regulatory
Approval (i) to market and sell Product in the Territory or any part
thereof for use in any part of the Field or (ii) to market and sell
Product in any country outside the Territory.
1.8 "CMC Development" means all 'chemical, manufacturing and controls'
development activities relating to Product designed to ensure the
registration of the Product both inside and outside the Territory,
including without limitation, Manufacture, scale-up, quality assurance,
quality control, Product characterization and stability.
1.9 "COGS" means the costs of producing the Product as defined in Schedule
8.
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1.10 "Collaboration Committee" means the committee to be established
pursuant to Clause 7.
1.11 "Commercialization Study" means any or all of the following:
1.11.1 studies required to obtain local opinion leader support ahead
of marketing outside of the Territory;
1.11.2 studies required to further study the use of the drug in
normal practice (for example Phase IV studies) outside the
Territory; or
1.11.3 studies required to support pricing and reimbursement outside
the Territory.
1.12 "Confidential Information" means that information defined as
confidential in Clause 53.1.
1.13 "Development Plan" means the plan, as amended from time to time, which
sets forth:
1.13.1 BB's strategies, plans, activities and estimated time
schedules with regard to Clinical Development in the Primary
Indication in the USA and the Territory; and
1.13.2 BB's strategies, plans, activities and estimated time
schedules for obtaining Regulatory Approvals for Product in
the Territory;
a draft of which is attached as Schedule 3 and which shall be
agreed by the parties pursuant to Clause 13.3 and amended
pursuant to Clauses 13.4 or 13.5.
1.14 "DM1" means that maytansinoid drug whose more specific chemical name is
N2'-deacetyl-N2'-(3-mercapto-1-oxopropyl)-maytansine.
1.15 "Effective Date" means 4th May 2000.
1.16 "EMEA" means the European Agency for the Evaluation of Medicinal
Products or its successor in title.
1.17 "Entity" means, and includes, any person, firm or company or group of
persons or unincorporated body.
1.18 "FDA" means the United States Food and Drug Administration or its
successor in title.
1.19 "Field" means the treatment of any and all human therapeutic
indications (including, without limitation, the Primary Indication) by
use of Licensed Compound and/or Product either alone or in combination.
1.20 "Good Manufacturing Practice" or "GMP" means current good manufacturing
practices for the methods to be used in, and the facilities and
controls to be used for the Manufacture and/or holding of Licensed
Compound or Product, all as set forth from time to time by the FDA and
relevant regulatory authorities in such other countries within the
Territory. With respect to the EU Territory, "GMP" means the standards
set out in The Rules Governing Medicinal Products in the European
Community, Volume IV and Annex to the EC Guide, Manufacture of
Investigational Medicinal Products (111/3004/91-EN) as amended from
time to time.
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CONFIDENTIAL TREATMENT REQUESTED.
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WITH THE SECURITIES AND EXCHANGE COMMISSION
1.21 "Gross Profits" means [*]
1.22 "huN901" means a humanized antibody which binds to the same epitope as
N901. One such humanized antibody has the cDNA sequence outlined in
Schedule 1, Part 1.
1.23 "huN901-DM1" means huN901 conjugated to DM1 using proprietary
technology developed by ImmunoGen.
1.24 "ICH Guidelines" means the applicable guidelines recommended by the
International Conference on Harmonization with regard to, amongst other
things, the conduct of laboratory, clinical or manufacturing activities
in respect of pharmaceutical products, as amended from time to time.
1.25 "ImmunoGen Improvements" means any inventions, discoveries,
improvements or enhancements relating to Licensed Compound or Product,
whether patented, patentable or non-patentable, conceived or first
reduced to practice by ImmunoGen during the term of this Agreement by
or on behalf of ImmunoGen, but independent of any patents, patent
applications, technical information, know-how (including BB
Improvements) of BB, and in respect of which ImmunoGen is free to
disclose and grant licenses to BB.
1.26 "IND" means an Investigational New Drug Application filed with the FDA
or any other regulatory approval that may be required to be issued in
order to commence a Clinical Study in any one or more of the countries
within the Territory.
1.27 "Independent Third Party" means any Entity other than ImmunoGen, BB or
their respective Affiliates or any Sub-licensee.
1.28 "Joint Improvements" means any inventions, discoveries, improvements or
enhancements relating to Licensed Compound or Product, whether
patentable or non-patentable, conceived or first reduced to practice
jointly by both BB and ImmunoGen or by either party with the use of any
patents, patent applications, technical information or know-how or
improvements of the other party.
1.29 "Launch" means, in respect of each country within the Territory, the
first commercial sale of Product by BB or Sub-licensees within such
country for the treatment of a particular disease indication within the
Field following Regulatory Approval.
1.30 "Licensed Compound" means huN901-DM1. huN901-DM1 is illustrated by the
structure more particularly set out in Schedule 1, Part 2.
1.31 "Licensed IP" means the Patents, Technical Information, Manufacturing
Information, Third Party Licenses and ImmunoGen's interest in any Joint
Improvements.
1.32 "Major EU Markets" means France, Germany, Italy, Spain and the UK.
1.33 "Manufacture" means all such steps and processes to be undertaken to
produce Product in appropriate pharmaceutical form including, without
limitation to the generality of the foregoing, formulation of Licensed
Compound or Product with appropriate excipients for oral use, its
tabletting or encapsulation, its filling into ampoules or vials for
intravenous, subcutaneous or similar administration, all in-process and
final quality control testing, assessment and release, the labeling,
insertion of inserts and packaging, all in compliance with the
applicable specifications and GMP.
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1.34 "Manufacturing Information" means all information and know-how in the
possession and at the free disposal of ImmunoGen in relation to the
methods and processes for the Manufacture of huN901-DM1 or Product,
including all in-process and final release test methods together with
information and know-how relating to the co-formulation of Licensed
Compound or Product with another product or pharmaceutical agent, to
the extent applicable.
1.35 "Market Exclusivity" means, in respect of any country in the Territory
where a Patent subsists, that BB can enforce its rights under the
Patent licenses granted to it pursuant to this Agreement to prevent an
Independent Third Party from commercializing a generic compound
containing Licensed Compound or Product (whether alone or in
combination with other therapeutically active compounds).
1.36 "N901" means any antibody or fragment thereof which has the six
complementarity-determining region sequences as described in Schedule
1, Part 1.
1.37 "Net Sales" means the total gross amounts invoiced in respect of all
sales of Product by or on behalf of BB to an Independent Third Party,
and exclusive of inter-company transfers or inter-company sales, less:
1.37.1 normal and customary trade, cash and quantity discounts,
allowances and credits granted or allowed;
1.37.2 credits or allowances actually granted for damaged goods,
returns or rejections of Product and retroactive price
reductions;
1.37.3 sales taxes, duties or other taxes with respect to such sales
(including duties or other governmental charges levied on,
absorbed or otherwise imposed on the sale of Product
including, without limitation, value added taxes or similar
taxes or other governmental charges otherwise measured by the
billing amount, when included in billing but excluding income
or other taxes levied with respect to gross receipts) actually
collected by BB or Sub-licensees;
1.37.4 insurance, postage, customs duties and transportation costs
incurred in shipping Product to any Independent Third Party by
BB or Sub-licensees to the extent separately itemized and
included in the invoiced amount;
1.37.5 charge back payments and rebates granted to managed health
care organizations or to federal, state and local governments,
their agencies, and purchasers and reimbursers or to trade
customers, including but not limited to, wholesalers and chain
and pharmacy buying groups;
1.37.6 rebates (or equivalents thereof) granted to or charged by
national, state or local governmental authorities in countries
other than the United States.
1.38 "Patents" means the patents and patent applications set out in Schedule
2 and any other patents or patent applications that ImmunoGen has been
granted or has filed in the Territory or any part thereof at the
Effective Date and any further patents or patent applications that
ImmunoGen may be granted or may file in the Territory or any part
thereof with regard to the composition of matter, methods of
administration, processes and/or intermediates for preparing,
formulation or use of Licensed Compound or Product in the Field
(whether alone or in combination with another
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product or pharmaceutical agent) including patent applications made in
respect of ImmunoGen Improvements thereto, and any continuations,
continuations-in-part, patents of addition, revisions, divisions,
substitutions, registrations, confirmations, any other patent
applications claiming priority from any of those patents or patent
applications, re-examinations, reissues, renewals or extensions
(including supplementary protection certificates or their equivalent)
of any such patents and international equivalents thereof.
1.39 "Pre-Clinical Development" means all activities relating to the conduct
of Pre-Clinical Studies specifically required to support Regulatory
Approvals to market and sell Product in the USA or the Territory.
1.40 "Pre-Clinical Study" means any one of those studies, other than a
Clinical Study, carried out, in vivo or in vitro, by or on behalf of
ImmunoGen on Licensed Compound and/or Product including, without
limiting the generality of the foregoing, drug absorption,
distribution, metabolism and excretion ("ADME"), toxicology,
pharmacokinetics, pathology, pharmaceutical formulation, drug
metabolism, stability and pharmacology studies which are required or
advisable to be carried out in order to obtain the grant of an IND to
develop Licensed Compound and/or Product in any one or more countries
of the Territory and/or required for Regulatory Approval purposes.
1.41 "Primary Indication" means small cell lung cancer.
1.42 "Product" means Licensed Compound in any pharmaceutical form or dosage
in which Licensed Compound is developed, manufactured, packaged,
marketed, used or sold in final form by prescription, over-the-counter
or any other method in accordance with the terms of this Agreement.
1.43 "Regulatory Approval" means the technical, medical and scientific
licenses, registrations, authorizations or approvals (including,
without limitation, approvals of BLA's, supplements, amendments,
pre-and post-approvals, pricing and third party reimbursement
approvals; marketing authorizations based upon such approvals,
including any prerequisite manufacturing approvals or authorizations
related thereto and labeling approval(s)), of any national, regional,
state or local regulatory agency, department, bureau, commission,
council or other governmental entity, necessary for the development,
manufacture, distribution, marketing, promotion, offer for sale, use,
import, export or sale of Licensed Compound and/or Product by BB in the
Territory or any part thereof or by ImmunoGen outside the Territory or
any part thereof.
1.44 "Regulatory Authority" means the EMEA or its equivalent in each part of
the Territory or the FDA in North America or its equivalent in other
countries outside the Territory.
1.45 "Specifications" means the specifications for Licensed Compound and
Product and any raw materials employed in the Manufacture thereof to be
established pursuant to Clause 19.
1.46 "Sub-licensee" means any Entity, not being an Affiliate of BB, which is
authorized directly by BB through express license or consent to
develop, make, have made, import, export, use, keep (whether for
disposal or otherwise), distribute, market, promote, offer for sale and
sell Licensed Compound and/or Product in the Territory or any part
thereof for use in the Field in accordance with the provisions of this
Agreement.
1.47 "Technical Information" means all information, know-how and/or
expertise in relation to the research, development or use of huN901-DM1
in the Field, whether alone or in combination with another product or
pharmaceutical agent, (excluding Manufacturing Information) including,
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without limiting the generality of the foregoing, (1) results of
Pre-Clinical Studies and Clinical Studies, (2) discoveries, practices,
methods, knowledge, processes, ideas, skill, experience, know-how,
technology, trade secrets, purification and isolation techniques,
instructions, formulae, data, assays, drawings and designs, (3)
chemical, pharmacoeconomic, toxicological, pharmacological, analytical,
safety, quality control and testing data, and (4) all applications,
registrations, licenses, authorizations, approvals and correspondence
submitted to or received from any regulatory authorities in the
Territory relating to huN901-DM1 (including, without limitation,
minutes and meeting notes relating to any communications with any
regulatory authority in the Territory relating to huN901-DM1) in the
possession and at the free disposal of ImmunoGen, BB or Sub-licensees.
1.48 "Territory" means:
1.48.1 all countries for the time being of the European Union ("EU")
and the European Economic Area ("EEA") as constituted at the
Effective Date. For the avoidance of doubt, new member
countries of the EU and/or the EEA will automatically be
included in the definition of Territory provided that
ImmunoGen has not otherwise licensed the Licensed IP to
another party in that country between the Effective Date and
the date the country joins either the EU or the EEA; and
1.48.2 Japan.
1.49 "Third Party Licenses" means the licenses to third party intellectual
property rights, including without limitation, patents, patent
applications, trade secrets, technical information and/or know-how
covering or related to N901, huN901, DM1, huN901-DM1, Licensed
Compound, Product or the manufacture thereof, under which ImmunoGen or
its Affiliates have a right to grant a sublicense to BB. A list of
Third Party Licenses is attached as Schedule 5.
1.50 The singular includes the plural and vice versa, words denoting any
gender include all genders.
1.51 Where the context so admits or requires, references to "ImmunoGen" and
"BB" and "Sub-licensee(s)" shall include their respective employees,
officers, directors and agents.
1.52 Headings to Clauses in this Agreement are included for convenience only
and shall not affect the construction and interpretation of this
Agreement.
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PART A - COMMENCEMENT PROVISIONS
2 GRANT AND ACCEPTANCE OF RIGHTS
2.1 GRANT to BB. Subject to the terms and conditions of this Agreement,
ImmunoGen grants to BB and its Affiliates an exclusive license,
exclusive even as to ImmunoGen, under the Licensed IP to:
2.1.1 develop Licensed Compound for the Primary Indication in the
USA and the Territory;
2.1.2 develop Licensed Compound for such other indications as may be
agreed pursuant to Clause 16 in the Field in the USA and the
Territory;
2.1.3 file applications for, and obtain, Regulatory Approvals
relating to Licensed Compound in the Field in the Territory;
and
2.1.4 import, export, keep (whether for disposal or otherwise),
market, distribute, use, promote, offer for sale and sell
Licensed Compound or Product in the Territory;
together with the right to grant sub-licenses pursuant to Clauses 3.1
and 3.2.
BB accepts the exclusive rights granted by ImmunoGen pursuant to Clause
2.1 subject to the terms and conditions of this Agreement.
2.2 GRANT TO ImmunoGen. Subject to the terms and conditions of this
Agreement BB grants to ImmunoGen and its Affiliates an exclusive
license (exclusive even as to BB), under BB Improvements and BB's
interest in Joint Improvements, to:
2.2.1 develop Licensed Compound for such other indications as may be
agreed pursuant to Clause 16 in the Field outside of the
Territory;
2.2.2 file applications for, and obtain, Regulatory Approvals
relating to Licensed Compound in the Field outside the
Territory; and
2.2.3 import, export, keep (whether for disposal or otherwise),
market, distribute, use, promote, offer for sale and sell
Licensed Compound or Product outside the Territory.
together with the right to grant such licenses pursuant to
Clauses 3.1 and 3.2.
2.3 THIRD PARTY TECHNOLOGY. The parties acknowledge that the licenses
granted to BB in this Agreement include sub-licenses under Third Party
Licenses. [*] BB agrees to abide by the terms and conditions of such
Third Party Licenses applicable to BB as ImmunoGen's sublicensee.
ImmunoGen shall use reasonable commercial efforts to abide by the terms
and conditions of all Third Party Licenses to maintain the Third Party
Licenses for BB as ImmunoGen's sublicensee. ImmunoGen agrees not to
terminate or assign, nor by act or omission permit the termination or
assignment of, any of the Third Party Licenses, nor to amend or by act
or omission permit the amendment of any Third Party Licenses to the
extent such an amendment would adversely affect BB's rights under this
Agreement, without the prior written consent of BB, which consent will
not be unreasonably withheld. Within [*] after entering into any
amendment of a Third Party License, ImmunoGen shall notify BB and
provide BB with a copy of the amendment. To the extent that ImmunoGen
enters into any Further Third Party Licenses (as such term is defined
in Clause 41) the provisions of Clause 41 shall apply.
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CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
2.4 REGISTRATION OF LICENSE. BB and any Sub-licensee shall be entitled to
be registered as a licensee of any Patents in respect of the rights
granted pursuant to Clause 2.1 in the Field in any part of the
Territory where such registration is possible and ImmunoGen shall do
all acts and sign and swear such documents as may be reasonably
required by BB to procure such registration and all fees and expenses
reasonably incurred by ImmunoGen associated with such registration
shall be borne by BB.
3 SUB-LICENSES
3.1 RIGHT TO GRANT. Either party shall have the right to grant sub-licenses
under the license granted by Clause 2.1 and 2.2, respectively, and to
employ Affiliates and Independent Third Parties in connection with the
performance of its rights and obligations under this Agreement, subject
to any limitations imposed upon either party's ability to sub license
by any Third Party License. BB's right to grant sub-licenses under this
Clause shall be exercisable provided that BB shall remain responsible
as primary obligor to ImmunoGen for the performance of its Affiliates
and/or Sub-licensees and provided, further, that BB shall remain
obligated to ensure payment of all compensation and royalty obligations
as set forth in Section C. BB confirms that it shall not grant a
Sub-licensee any greater rights than is reasonably required to enable
such Sub-licensee to fulfill its contractual obligations to BB.
3.2 TERMS OF SUB-LICENSE. The terms and conditions of each sub-license
granted pursuant to Clause 3.1 shall be communicated to the other party
in writing within [*] of the grant thereof (excluding financial terms
or information relating to products which are not covered by this
Agreement) and in order to be validly granted hereunder shall contain
the following provisions:
3.2.1 that the sub-license shall be personal to the Sub-licensee and
shall not be assignable or licensable;
3.2.2 covenants by the Sub-licensee to observe and perform
conditions at least equivalent to those contained in this
Agreement in respect of that part of the Territory to which
the sub-license applies insofar as the same are applicable
and, in addition, such sub-license shall also contain
provisions for ipso facto termination in whole or in part in
the event of, and contemporaneously with, the termination of
this Agreement or termination of this Agreement in respect of
that part of the Territory to which the sub-license applies.
Any sub-license purported to be granted by either party and not
containing the above provisions shall be deemed invalid and of no
effect against the other party until such time as such party remedies
the discrepancies.
4 OTHER COUNTRIES
4.1 RESTRICTIONS ON FUTURE ImmunoGen LICENSEES. Subject to Clause 4.2
below, ImmunoGen retains the right to grant licenses for the sale,
marketing and distribution of the Product in all countries outside the
Territory; provided, however, that ImmunoGen agrees that for each such
license entered into after the Effective Date, it will impose on each
such licensee, to the extent permitted by applicable law, a covenant
prohibiting the licensee from:
4.1.1 seeking approval, directly or indirectly, from the relevant
Regulatory Authorities, to label or re-label the Product in a
manner that would permit it to be marketed or sold inside the
Territory,
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WITH THE SECURITIES AND EXCHANGE COMMISSION
4.1.2 selling or exporting the Product to any Independent Third
Party for use or resale inside the Territory,
4.1.3 selling the Product to any Independent Third Party that
ImmunoGen has reason to believe intends to resell or export
the Product inside the Territory.
4.2 COVENANT. ImmunoGen covenants with BB, [*]:
4.2.1 [*];
4.2.2 [*];
4.2.3 [*];
4.2.4 [*];
4.2.5 [*].
5 PROVISION OF TECHNICAL INFORMATION AND ASSISTANCE
5.1 TIMETABLE FOR PROVISION. Within [*] of the Effective Date, ImmunoGen
shall make available to BB, and shall provide BB with a list of, all
Technical Information in its possession or control which it has not
previously disclosed to BB. BB shall, at its cost, be entitled to
conduct a review of such Technical Information and shall be entitled to
require ImmunoGen to provide BB with copies of such documentation as it
may request. Within [*] following receipt of such request, ImmunoGen
shall, at its cost, provide BB with copies of all such requested
documentation.
5.2 FURTHER TECHNICAL INFORMATION. Any further Technical Information
developed or acquired (whether by license, assignment or otherwise) by
ImmunoGen or which otherwise comes into ImmunoGen's possession during
the term of this Agreement shall be made available to BB at no cost as
soon as reasonably practicable after such development or acquisition by
ImmunoGen, to the extent ImmunoGen has the right to make such Technical
Information available to BB.
5.3 ASSISTANCE. ImmunoGen shall,[*] provide reasonable technical assistance
to enable BB to utilize such Technical Information.
6 TERM
6.1 This Agreement shall commence on the Effective Date and, unless
otherwise terminated, on a country by country basis, shall expire:
6.1.1 [*];
6.1.2 [*].
6.2 Upon the expiry of this Agreement by passage of time on a country by
country basis (as determined pursuant to Clause 6.1), BB shall not be
precluded from using any Technical Information or Manufacturing
Information without payment of royalties and shall be automatically
granted a fully paid-up, perpetual, transferable, royalty free,
non-exclusive license
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
to the Licensed IP (including, for the avoidance of doubt, ImmunoGen
Improvements) to develop, apply for Regulatory Approvals, import,
export, keep (whether for disposal or otherwise), market, distribute,
use, promote, offer for sale and sell Licensed Compound and/ or Product
in the Field in the Territory.
7 FORMATION OF COLLABORATION COMMITTEE
7.1 ESTABLISHMENT. To facilitate the development collaboration between the
parties contemplated by this Agreement, within [*] of the Effective
Date, the parties shall establish the Collaboration Committee
containing, for example, senior scientists, clinical research,
manufacturing, regulatory and/or marketing/sales members from both
parties.
7.2 APPOINTMENT OF MEMBERS. The Collaboration Committee shall consist of
six (6) members, three (3) of whom shall be appointed by BB and three
(3) of whom shall be appointed by ImmunoGen. Each party shall designate
its members to the Collaboration Committee and shall notify the other
party in writing if it substitutes or replaces any of its members,
whether on a permanent basis or due to the unavailability of a
particular member to attend a particular meeting.
7.3 MEETINGS. The Collaboration Committee shall meet at least four (4)
times per year unless otherwise agreed by the parties. Meetings may be
held by telephone or video conference or in person and members may
participate in any of the foregoing ways, it being recognized that it
is the current intention of the parties that the Collaboration
Committee should meet in person at least twice a year. To the extent
that it is necessary for the Collaboration Committee to meet in person,
unless otherwise agreed, such meetings shall alternate between Oxford,
UK and Boston, Massachusetts, USA. All costs relating to participation
by each member in the activities of the Collaboration Committee shall
be borne by the party appointing such member. Furthermore, if the
parties regard it as being necessary, the Collaboration Committee shall
be allowed to constitute sub-committees to deal with specific issues
that may arise and in such event the provisions of this Clause shall
govern the conduct and voting at such sub-committee meetings.
7.4 LANGUAGE. All meetings of the Collaboration Committee shall be held in
the English language and all documentation submitted to, or generated
by, the Collaboration Committee shall be in the English language.
7.5 QUORUM; VOTING. The presence of at least two (2) members, one (1) of
whom shall have been selected by each party, shall constitute a quorum
for the purpose of consideration and action by the Collaboration
Committee. Each party shall have only one (1) vote, irrespective of the
number of attendees at such meeting.
7.6 DEADLOCK. The Collaboration Committee shall strive to make decisions by
unanimous consensus. In the event that consensus cannot be reached on
matters assigned to the Collaboration Committee, then, save as
otherwise provided in this Agreement:
7.6.1 [*];
7.6.2 [*].
7.7 CHAIRMAN AND SECRETARY: RESPONSIBILITIES. The Collaboration Committee
shall appoint a Chairman and a Secretary from the members, it being
agreed that the Chairman shall be a member appointed by BB and the
Secretary shall be a member appointed by ImmunoGen. The Chairman shall
be responsible for calling meetings and preparing and circulating
agendas. The
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Secretary shall be required to prepare the minutes of the Collaboration
Committee meetings and to circulate these to the members within [*]
following the conclusion of the meeting. All Collaboration Committee
minutes shall, following review by the parties and agreement of their
contents, be countersigned on behalf of each party as evidence of
acceptance of the correctness of such minutes.
7.8 PARTICIPATION OF NON-MEMBERS. Additional non-voting representatives or
consultants may be invited by either ImmunoGen or BB to attend and
participate in Collaboration Committee meetings (for example, to
evaluate and advise on business or scientific issues) subject to
compliance with the confidentiality provisions of Clause 53. Each party
shall be responsible for the costs and expenses incurred in connection
with the attendance and participation in Collaboration Committee
meetings of representatives or consultants invited by such party.
7.9 COMMITTEE RESPONSIBILITIES. The Collaboration Committee shall be
responsible, without limitation, for monitoring and coordinating
certain of the parties activities regarding the development and
commercialization of Licensed Compound and/or Product as set out below:
7.9.1 [*];
7.9.2 [*];
7.9.3 [*];
7.9.4 [*];
7.9.5 [*];
7.9.6 [*];
7.9.7 [*];
7.9.8 [*];
7.9.9 [*];
7.9.10 [*];
7.9.11 [*]
7.9.12 [*]
7.9.13 [*]
7.9.14 [*];
7.9.15 [*];
7.9.16 [*];
7.9.17 [*]
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
7.9.18 [*].
7.10 ADDITIONAL RESPONSIBILITY: THIRD PARTY REQUESTS. In addition to its
other responsibilities, the Collaboration Committee shall also be
responsible for considering any requests from Independent Third Parties
relating to potential investigator-held IND studies, compassionate use
of Licensed Compound or extension studies, and to the extent that the
Collaboration Committee unanimously agrees to the commencement of such
activity it shall agree how the costs relating thereto shall be borne
by the parties;
7.11 PERIOD OF EXISTENCE. The Collaboration Committee shall remain in
existence until the termination of the Agreement in all countries
within the Territory or until disbanded by agreement of the parties.
7.12 Save as specifically provided in this Agreement, the Collaboration
Committee shall not be entitled or have the power to vary or amend the
terms of this Agreement or commit either party to any financial
expenditure not contemplated in this Agreement.
PART B - ADDITIONAL GRANT PROVISIONS
8 [*]
8.1 [*]
9 [*]
9.1 In the event that the [*]:
9.1.1 [*];
9.1.2 [*];
9.1.3 [*];
9.1.4 [*];
[*]
9A [*]
9A.1 If during the term of this Agreement, [*]
9A.2 In the event that the parties are unable to reach agreement on terms
following [*]days good faith discussions, such negotiations shall
cease, unless otherwise agreed.
PART C - COMPENSATION PROVISIONS
10 COMPENSATION
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10.1 INITIAL PAYMENT. In consideration of the rights granted to it under
this Agreement, BB shall pay in cash to ImmunoGen the sum of one
million five hundred thousand United States dollars (US$1,500,000)
within ten (10) business days following the Effective Date.
10.2 PAYMENT BY ImmunoGen. In consideration for the performance of those
clinical trials which BB has agreed to conduct under this Agreement,
ImmunoGen agrees to pay to BB the sum of [*] days of the grant to
ImmunoGen of a BLA in the USA.
10.3 MODE OF PAYMENT. Payment of the consideration referred to in Clause
10.1 or 10.2 shall be paid by check or bank wire transfer in
immediately available funds to such bank account as is designated in
writing by the receiving party.
11 ROYALTIES IN RESPECT OF SALES OF LICENSED COMPOUND AND/OR PRODUCT
11.1 As further consideration for the rights granted to BB under this
Agreement, BB shall pay to ImmunoGen a royalty in respect of Gross
Profit for Licensed Compound and/or Product in the Territory made by BB
or Sub-licensees, for the term of this Agreement as provided for in
Clause 6, on the following basis:
11.1.1 BB shall pay a royalty of[*] of Gross Profit to ImmunoGen in
respect of sales of Product in each country in the Territory
where [*].
11.1.2 BB shall pay a royalty of [*] of Gross Profit to ImmunoGen in
respect of sales of Product in each country in the Territory
where:
11.1.2.1 [*]
11.1.2.2 [*].
11.2 INTERNAL TRANSFERS. No royalties shall be due upon the sale or other
transfer of Licensed Compound or Product among BB or Sub-licensees, but
in such cases the royalty shall be due and calculated upon BB's or its
Sub-licensees' sale to the first Independent Third Party.
11.3 SAMPLES AND DONATIONS. No royalties shall accrue on the disposition of
Licensed Compound or Product by BB or Sub-licensees as samples
(promotion or otherwise) or as donations (to non-profit institutions or
government agencies for a non-commercial purpose) or for Clinical
Studies, it being agreed that BB or Sub-licensees shall not in
aggregate dispose of more than [*] of annual sales of Licensed Compound
and Product by way of sample or donation, it being further expressly
agreed that donations of Licensed Compound and Product [*].
11.4 PAYMENT OF ROYALTIES; CURRENCY AND EXCHANGE. Payments to be made by BB
to ImmunoGen under this Agreement, and in accordance with Clause 12.4
and 12.5, shall be paid by check or by bank wire transfer in
immediately available funds to such bank account as is designated in
writing by ImmunoGen from time to time. Royalties shall be deemed
payable from the country in which they are earned in local currency and
subject to foreign exchange regulations then prevailing. Royalty
payments shall be made in United States dollars to the extent that free
conversion to United States dollars is permitted. The rate of exchange
to be used in any such conversion from the currency in the country
where such sales are made shall be the average rate of exchange
applicable for the relevant Accounting Period as determined by the Bank
of New York. If, due to restrictions or prohibitions imposed by any
national or international authority, payments cannot be made as
aforesaid, the parties shall consult with a view to finding a prompt
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and acceptable solution, and BB will deal with such monies as ImmunoGen
may lawfully direct at no additional out-of-pocket expense to BB.
Notwithstanding the foregoing, if royalties in any country cannot be
remitted to ImmunoGen for any reason within six (6) months after the
end of the relevant Accounting Period during which they are earned,
then BB shall be obligated to deposit the royalties in a bank account
in such country in the name of ImmunoGen.
12 ACCOUNTING AND PAYMENT
12.1 AUDIT OF RECORDS. BB shall, and shall procure that any Sub-licensee
shall, keep at its usual place of business complete and proper records
and books of account showing the quantity, description and sales of
Licensed Compound and/or Product sold hereunder and in respect of each
country within the Territory. Upon forty-five (45) days prior written
notice from ImmunoGen, BB shall permit an independent certified public
accounting firm of nationally recognized standing selected by ImmunoGen
and approved by BB (such approval not to be unreasonably withheld or
delayed) at ImmunoGen's expense, to examine pertinent books and records
of BB and Sub-licensees at their respective usual places of business as
may be reasonably necessary to verify the accuracy of the royalty
reports hereunder and BB shall procure the cooperation of Sub-licensees
in this regard. BB may designate competitively sensitive information
which such auditor may see and review but which it may not disclose to
ImmunoGen; provided however, that such designation shall not encompass
or restrict the auditor's conclusions. The accounting firm shall be
entitled to report to ImmunoGen on the scope of its audit, any
reservations that it may have resulting from such audit, any other
material information which it determines in its reasonable opinion
should be brought to ImmunoGen's attention and to disclose to ImmunoGen
whether it is of the opinion that the royalty reports are correct or
incorrect and the specific details concerning any discrepancies. No
other information shall be provided to ImmunoGen. ImmunoGen shall
obtain a confidentiality agreement (in form and substance reasonably
acceptable to BB) requiring such auditor to keep any information
gathered from the inspection of such records and books confidential,
for the sole purpose of verifying the accuracy of the payments made by
BB under this Agreement. Such review shall be conducted no more
frequently than once per calendar year and shall be scheduled during
ordinary business hours at such a time as is reasonably acceptable to
BB.
12.2 RETENTION OF RECORDS. Such books and records referred in Clause 12.1
shall be retained by BB or Sub-licensees for two (2) years from the
date of their origin; provided that, if a review is requested during
the third year, each such book and record subject to review shall be
retained for one (1) year beyond the completion of the review. Any
adjustment required as a result of such review to the sums payable by
BB to ImmunoGen shall be made in the next payment by BB to ImmunoGen.
Furthermore, in the event of a dispute between the parties relating to
such books or accounts, BB shall, and shall procure that Sub-licensees
shall, retain such books and accounts until such dispute is settled or
a final unappealable decision has been reached by the competent
judicial authorities.
12.3 BINDING CALCULATION. Upon the expiration of the two (2) year period set
forth above, the calculation of royalties payable under this Agreement
with respect to such year shall be binding and conclusive upon the
parties, and BB and Sub-licensees shall be released from any liability
or accountability with respect to royalties for such calendar year.
12.4 PROVISION OF ROYALTY STATEMENT. Within forty-five (45) days of the end
of each Accounting Period, BB shall submit or cause to be submitted to
ImmunoGen a written statement in respect of BB and Sub-licensees
recording the quantity and description and of Licensed Compound and/or
Product invoiced hereunder in each country in the Territory during the
relevant
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Accounting Period to which the report relates together with a
calculation of Gross Profit. In the event that no invoiced sales of
Licensed Compound and/or Product have been made during any such
Accounting Period, BB shall submit a nil statement.
12.5 SIMULTANEOUS PAYMENT. Simultaneously with the submission of such
written statement, BB shall pay to ImmunoGen a sum equal to the royalty
due for such Accounting Period, calculated in accordance with this
Agreement (reconciled for any previous overpayments or underpayments).
12.6 WITHHOLDING TAXES. If at any time, any jurisdiction within the
Territory requires the withholding of income taxes or other taxes
imposed upon payments set forth in this Agreement, BB shall make such
withholding payments as required and subtract such withholding payments
from the payments set forth in this Clause. BB shall provide ImmunoGen
with documentation of such withholding and payment in a manner that is
satisfactory for purposes of UK tax laws. Any withholdings paid when
due hereunder shall be for the account of ImmunoGen and shall not be
included in any calculation of Gross Profit. To the extent that
payments of withholding taxes made by BB pursuant to this Clause are
based upon financial information to be provided to BB by ImmunoGen and,
to the extent that such information is incorrect or incomplete,
ImmunoGen shall be liable for any fine, assessment or penalty, or any
deficiency, imposed by any taxing authority in the Territory for any
deficiency in the amount of any such withholding or the failure to make
such withholding payment. If BB is required to pay any such deficiency,
or any such fine, assessment or penalty for any such deficiency,
ImmunoGen shall promptly reimburse BB for such payments, which shall
not be included in the calculation of Gross Profit. BB shall and shall
procure that any Sub-licensees shall, at its cost, give ImmunoGen such
reasonable assistance, which shall include the provision of appropriate
certificates of such deductions made together with other supporting
documentation as may be required by the relevant tax authority, to
enable ImmunoGen to claim exemption from such withholding or other tax
imposed or obtain a repayment thereof or reduction thereof and shall
upon request provide such additional documentation from time to time as
is reasonably required to confirm the payment of tax.
PART D - CLINICAL DEVELOPMENT PROVISIONS
12A PREPARATION AND FILING OF IND APPLICATION
12A.1 While it is agreed that BB shall be responsible for the preparation and
submission of the application for an IND in its name, it is
acknowledged that ImmunoGen is in possession of, and developed, certain
Technical Information that may form a substantive proportion of the IND
application. In recognition of the foregoing, as soon as reasonably
practicable following the Effective Date, the parties shall meet to
commence the preparation of the IND application and ImmunoGen shall
provide BB with all necessary information, advice, assistance,
documentation and data as may be reasonably requested by BB for and in
connection with the preparation of such IND application.
12A.2 If requested by BB, ImmunoGen shall attend a pre-IND submission meeting
with the relevant Regulatory Authorities and answer such questions as
the Regulatory Authorities may have relating to the data generated by
ImmunoGen and to advise and assist BB as may be reasonably required. To
the extent that a Regulatory Authority requires any amendments to the
IND which require the assistance of ImmunoGen, ImmunoGen shall provide
such assistance. In addition, if
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
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any further assistance is required following submission, and prior to
approval of the IND approval, ImmunoGen provide such assistance to BB
in accordance with any timetable set by BB for responding to such
Regulatory Authority's requests.
12A.3 If, following the pre-IND meeting, BB reasonably believes that the
Development Plan requires amendment(s) to reflect the views expressed
or comments made by the Regulatory Authority, the Collaboration
Committee shall meet to agree any amendments to be made to such Plan.
13 DEVELOPMENT PLAN
13.1 CONTENTS OF PLAN. The Development Plan will set out, amongst other
things, the details of those Agreed Clinical Studies that BB is
obligated to undertake, a copy of which is attached at Schedule 3. It
is expressly agreed that BB may discharge its responsibilities under
the Development Plan through its Affiliates, Sub-licensees or
Independent Third Parties under contract.
13.2 OBJECTIVE OF PLAN. The initial objective of the Development Plan shall
be the generation of a body of data (in addition to the Technical
Information) that shall be sufficient to support the filing of
applications for Regulatory Approvals to enable (a) BB to commence the
sale of Product in respect of the treatment of the Primary Indication
in the Territory; and (b) ImmunoGen to commence the sale of Product in
respect of the treatment of the Primary Indication in the USA.
13.3 AGREEMENT OF PLAN. The Development Plan shall be agreed by the parties
within [*] of the Effective Date (subject always to any amendments
required pursuant to Clause 12A.3). For this purpose, representatives
of the parties shall meet as frequently as required following the
Effective Date in order to agree the Development Plan. Following
agreement of the Development Plan by the parties, such Plan shall be
submitted to the FDA for review and approval at a pre-IND meeting. Any
amendments required by the FDA shall be incorporated into the
Development Plan. The Development Plan shall be designed on the
assumption that BB shall devote all reasonably necessary resources
(including financial and manpower resources) in the conduct of the
Agreed Clinical Studies in order to meet the timetable stipulated in
the Development Plan.
13.4 ANALYSIS OF DATA; REVISIONS TO PLAN. Following agreement of the
Development Plan, the Collaboration Committee shall regularly review
such Plan in the light of clinical data arising from the reporting of
each of the Agreed Clinical Studies and to changing regulatory
requirements and consider the effect (if any) that such data or
regulatory changes may have on the Development Plan and agree any
appropriate revisions to be made thereto.
13.5 AMENDMENTS TO PLAN. In agreeing the Development Plan the parties
recognize that:
13.5.1 certain reasonable variations (both shortening and
lengthening) of the Development Plan timetable may be required
in which case the parties shall be able to make such
amendments as may be necessary and/or appropriate to the
Development Plan, which revised plan shall thereafter become
the Development Plan;
13.5.2 the Development Plan (or parts thereof) may be unattainable if
unforeseen material technical problems beyond BB's control
arise (which shall not include technical problems arising as a
result of insufficient resource being devoted to the
Development Plan by
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
either party or Sub-licensees) and that significant alteration
or amendment may have to be made to the Development Plan (or
parts thereof) as a result of such technical problems. Should
this occur, any amendment that may be necessary to the
Development Plan shall be agreed between the parties and such
amended Development Plan shall thereafter be the Development
Plan.
13.6 COORDINATION OF PLAN. The Development Plan shall be coordinated and
supervised by the Collaboration Committee. In order to enable the
Collaboration Committee to carry out its duties of coordination and
supervision with regard to the Development Plan, BB shall, following
agreement of the Development Plan, be required to report to each
meeting of the Collaboration Committee which shall include the progress
made with the Development Plan since the Effective Date or the last
meeting of the Collaboration Committee (as the case may be).
13.7 ImmunoGen DEVELOPMENT PLAN.
13.7.1 Within [*] of the Effective Date the Collaboration Committee
shall meet to agree a development plan prepared by ImmunoGen
relating to ImmunoGen's strategies, plans, activities and
estimated time schedules for obtaining Regulatory Approval in
the USA.
13.7.2 In due course, following the grant of Regulatory Approval in
the USA, the Collaboration Committee shall meet to agree a
development plan prepared by ImmunoGen relating to ImmunoGen's
plans, activities and estimated time schedules for obtaining
Regulatory Approval in such other of ImmunoGen's retained
territories.
Once such plans have been agreed, the provisions of Clauses 13.4, 13.5
and 13.6 (as adjusted, to the extent necessary, to substitute ImmunoGen
for BB) shall apply in respect of such plans.
14 PRE-CLINICAL STUDIES AND PHARMACOKINETIC STUDIES
14.1 RESPONSIBILITY. ImmunoGen shall be responsible, at its cost, for all
necessary Pre-Clinical Development required to be conducted in respect
of the development of Licensed Compound or Product to enable Regulatory
Approval to be obtained both inside and outside the Territory. The
Collaboration Committee shall be responsible for determining what
Pre-Clinical Studies need to be conducted with regard to development of
the Licensed Compound and in this regard within [*] of the Effective
Date, the Collaboration Committee shall meet to agree upon a formal
Pre-Clinical Development plan. Once such plan has been agreed, the
provisions of Clauses 13.4, 13.5 and 13.6 (as adjusted, to the extent
necessary, to substitute ImmunoGen for BB and references to Development
Plan for Pre-Clinical Development plan) shall apply in respect of such
plan.
14.2 It is further agreed that ImmunoGen shall carry out, on BB's behalf,
all necessary bioanalysis in support of the phase I Clinical
Development programme, including, without limitation, plasma huN901 and
huN901-DM1 (conjugate) pharmacokinetics (PK) by ELISA and human
anti-human antibody (HAHA) and human anti-DM1 antibody (HADA)
responses. Plasma huN901-DM1 bioactivity may also be measured in plasma
samples, as agreed by the Collaboration Committee. Such studies are
required to support applications for Regulatory Approvals in the
Territory and the USA and ImmunoGen shall provide BB with written
reports relating thereto in a form suitable for use in applying for
Regulatory Approvals. BB agrees to reimburse ImmunoGen for its direct
costs in carrying out any of the above agreed studies in accordance
with the provisions of Schedule 9. In addition, ImmunoGen shall provide
all necessary documentation and assistance to support Regulatory
Approvals in the Territory in respect of any such studies so conducted.
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
15 AGREED CLINICAL STUDIES
15.1 RESPONSIBILITY. BB shall be responsible for and shall bear all its
costs associated with conducting, and preparing clinical reports on,
the Agreed Clinical Studies. The Agreed Clinical Studies shall be
conducted in accordance with all applicable laws and regulations in
force from time to time and in accordance with the Development Plan.
15.2 DATA SHARING. In recognition of the fact that ImmunoGen shall be
responsible for filing applications for Regulatory Approval with the
appropriate regulatory authorities in respect of the Primary Indication
outside the Territory, BB agrees that, following the completion of the
Agreed Clinical Studies and generation of clinical reports, it shall
make available to ImmunoGen all necessary data relating to the Agreed
Clinical Studies with respect thereto to enable ImmunoGen to file
applications for Regulatory Approvals outside the Territory.
16 CLINICAL DEVELOPMENT FOR OTHER INDICATIONS
16.1 OTHER INDICATIONS. With regard to the pre-clinical and clinical
development of Licensed Compound for all indications [*] other than the
Primary Indication, the parties shall be responsible for such
activities on equivalent terms as provided in this Agreement. Prior to
the commencement of clinical development of Licensed Compound for other
indications, to the extent that either party wishes to recommend such
development, such party shall make a proposal for development to the
Collaboration Committee outlining the following matters:
16.1.1 the scientific rationale for development;
16.1.2 the commercial viability for Licensed Compound in the
treatment of such indication; and
16.1.3 the proposed development plan;
it being agreed that in the event that the Collaboration Committee is
not able to reach unanimous consensus on development, then development
of the Licensed Compound for such indication shall not proceed.
17 INVESTIGATORS' MEETINGS
17.1 RIGHT TO ATTEND. In respect of any Clinical Studies conducted by one
party, the other party shall, at its own cost, have the right (but not
the obligation) to ensure that one of its senior clinical staff is
present as an observer at any major investigators' meeting taking place
subject to the prior consent of the investigators attending the
meeting. The party conducting the meeting will use its reasonable
efforts to obtain such consent prior to any such meeting.
17.2 LIMITATION OF RIGHT. It is agreed by the parties that to the extent
that a representative is in attendance at a major investigators'
meetings in respect of the other party's Clinical Studies, such
representative shall only be entitled to be present to the extent that
Licensed Compound or Product are being discussed and not other
unrelated independent products, compounds or other confidential
information proprietary to that other party.
18 ADVERSE EVENT REPORTING
18.1 AGREEMENT OF REPORTING PROCEDURE. Within[*]of the Effective Date, the
parties shall meet to agree upon standard operating procedures for the
investigation and reporting of adverse experiences concerning Licensed
Compound or Product. Such written procedures shall be approved by the
parties within[*] of the Effective Date and for the avoidance of doubt
shall
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also relate to BB's Sub-licensees or ImmunoGen's licensees outside the
Territory. Giving due consideration to each parties current standards
pursuant to which they conduct adverse event reporting, the following
matters shall be taken into account when agreeing the standard
operating procedures:
18.1.1 BB shall be responsible for the investigation and reporting of
adverse experiences in respect of the Agreed Clinical Studies;
18.1.2 in respect of Clinical Studies conducted for other indications
within the Field, BB shall be responsible for the
investigation and reporting of adverse experiences in respect
any Clinical Studies it conducts in the Territory and
ImmunoGen shall be responsible for the investigation and
reporting of adverse experiences in respect of any Clinical
Studies it conducts outside the Territory;
18.1.3 each party shall notify the other party at least in accordance
with the time limits laid down in the ICH Guidelines for the
time being in force of the receipt by it (or such other more
stringent standards that the parties may agree) of a report of
a "serious adverse experience" or "unexpected adverse
experience" (as defined below). The notification shall be made
in the format mutually agreed from time to time and shall be
sent by express courier or facsimile transmission or, if none
of these methods is available, notification shall be made by
telephone with written copy to follow by the fastest available
means;
18.1.4 the relevant party shall promptly investigate a serious
adverse experience and shall submit follow-up reports (copies
of which shall be provided to other party) at least in
accordance with the ICH Guidelines' time limits (or such other
more stringent time limits as the parties may agree) of the
receipt of new information;
18.1.5 each party shall notify the other party of any other adverse
experiences, not being serious adverse experiences or
unexpected adverse experiences;
18.1.6 in respect of those Clinical Studies for which it is
responsible, BB shall be responsible for reporting all
relevant adverse experiences relating to Licensed Compound or
Product to the relevant regulatory authorities in the
Territory in accordance with the legal requirements prevailing
from time to time in the Territory with respect to such
reporting. ImmunoGen shall, where reasonably necessary, assist
BB in such reporting; and
18.1.7 in respect of those Clinical Studies for which it is
responsible, ImmunoGen shall be responsible for reporting all
relevant adverse experiences relating to Licensed Compound or
Product to the relevant regulatory authorities in the
Territory in accordance with the legal requirements prevailing
from time to time outside the Territory with respect to such
reporting. BB shall, where reasonably necessary, assist
ImmunoGen in such reporting.
18.2 DEFINITIONS. For the purposes of this Clause:
"serious adverse experience" shall mean any adverse event associated
with the use of Product in humans (whether or not considered
drug-related) that gives rise at any dose to one or more of the
following: death, threat to life, new or prolonged in-patient
hospitalization, permanent, persistent or significant disability or
incapacitation, overdose, congenital abnormality, a congenital anomaly
or birth defect or any other serious event or laboratory abnormality
which is thought by the reporting physician to be serious or associated
with relevant clinical signs or symptoms; and
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"unexpected adverse experience" shall mean any adverse event that is
not consistent in nature, severity, or frequency with information
contained in the current clinical investigation brochure for Product
not yet marketed or in the approved prescribing information for
marketed Product.
PART E - MANUFACTURING AND SUPPLY PROVISIONS
19 PRODUCT SPECIFICATION
19.1 AGREEMENT AND AMENDMENT. Within [*] of the Effective Date, the parties
shall meet to review and agree upon initial Specifications for Licensed
Compound and/or Product. Such initial Specifications shall be agreed
upon through good faith discussions by the parties within [*] of the
Effective Date, and shall set forth reasonably attainable
specifications based upon data accumulated from historical batches of
Licensed Compound, including without limitation safety and
manufacturing data. Such agreed Specifications shall be designed to
meet all applicable regulatory requirements and shall then be used as
the standard pursuant to which ImmunoGen shall fulfill its
Manufacturing and supply obligations under this Agreement. The
Specifications may be amended from time to time by the parties as
required to reflect the development of Product or as required to obtain
Regulatory Approval for the Product.
19.2 AMENDMENT FOR REGULATORY PURPOSES. Following Regulatory Approval for
Product in the Territory, BB shall have the right to require ImmunoGen
to modify (i) the Specifications and (ii) the facilities, equipment and
quality control procedures applicable to Product, in each case to the
extent required by Regulatory Authorities in the Territory.
20 TRANSFER OF MANUFACTURING INFORMATION
20.1 TIMETABLE FOR PROVISION. Within [*] of the Effective Date, ImmunoGen
shall make available to BB, and shall provide BB with a list of, all
Manufacturing Information. BB shall, at its cost, be entitled to
conduct a review of such Manufacturing Information and shall be
entitled to require ImmunoGen to provide BB with copies of such
documentation as it may request. Within [*] following receipt of such
request, ImmunoGen shall, at its cost, provide BB with copies of all
such requested documentation.
21 DEVELOPMENT OBLIGATIONS OF IMMUNOGEN
21.1 DEVELOPMENT OF PRODUCT. ImmunoGen agrees that it shall, [*] be
responsible for the continued development of the Licensed Compound into
the final Product, in a form acceptable to the Regulatory Authorities
in the USA and the Territory, which will be used by both BB and
ImmunoGen in the Clinical Development and commercialization of Licensed
Compound for the treatment of the Primary Indication. ImmunoGen shall
complete all reasonable steps required by the Regulatory Authorities to
obtain Regulatory Approval for Product sale in such dosage form. BB
shall have the right to consult with ImmunoGen with respect to such
development activities. In the event that ImmunoGen does not develop
the Licensed Compound or Product in a manner consistent with and within
the time frame set forth in the Development Plan, the parties shall
meet and discuss a reasonable amendment to the time frame. If the
parties are unable to agree upon such amendment within [*] BB shall
have the right, [*] to either take responsibility for such development
or appoint an Independent Third Party reasonably acceptable to
ImmunoGen to complete such activities.
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21.2 CMC DEVELOPMENT REQUIREMENTS. IMMUNOGEN AND BB WILL CONSULT, FROM TIME
to time, on the CMC Development that will be necessary to accumulate
data required for submitting a BLA for the Product in the Territory.
ImmunoGen shall be responsible for providing to BB in writing, all data
and documents necessary to complete the chemistry, manufacturing and
controls sections of applications for Regulatory Approval for Licensed
Compound in accordance with the timetable provided for in the
Development Plan. Such data and documents shall be of a form and
substance as might reasonably be expected to be sufficient to support
an application for Regulatory Approval. By way of example only, and
without limiting the generality of the foregoing, the parties agree
that such data and documents shall include, but not be limited to, the
method of manufacture, in-process and release specifications, completed
or ongoing stability program data, validated analytical procedures for
release and in support of the stability program, and development of all
appropriate packaging and labeling. Without limitation, certain of
ImmunoGen's CMC Development obligations are set out in Schedule 7 of
this Agreement. Furthermore, within[*] of the Effective Date the
Collaboration Committee shall meet and agree upon a formal CMC
Development Plan. Once such plan has been agreed, the provisions of
Clauses 13.4, 13.5 and 13.6 (as adjusted, to the extent necessary, to
substitute ImmunoGen for BB and references to Development Plan for CMC
Development plan) shall apply in respect of such plan.
21.3 DATA DEFICIENCIES. In the event that BB reasonably determines that the
data and documents provided by ImmunoGen pursuant to Clause 21.2 are
not of a form and substance as might reasonably be expected to be
sufficient for either the filing of an application for Regulatory
Approval or Regulatory Approval of Licensed Compound, then BB shall
submit to ImmunoGen in writing a description of the deficiencies in
such data or documents. Subject to Clause 21.4, ImmunoGen shall,
promptly, and at its own cost and expense, take all steps reasonably
necessary, including conducting additional analyses or manufacturing
additional Licensed Compound, to generate or otherwise obtain
sufficient data or documents necessary to cure the deficiency.
21.4 In the event that ImmunoGen disputes the determination in Clause 21.3
that the data or documents are deficient, then ImmunoGen shall submit
in writing to BB, within [*]of receipt of BB's notice of deficiencies
provided pursuant to Clause 21.3, above, ImmunoGen's bases for
disputing BB's determination. Within [*] of ImmunoGen's notice, the
parties shall either resolve the dispute or agree upon a procedure for
resolving the dispute. The procedure shall include either (a) the
selection of a third-party expert experienced in such matters who shall
review submissions from both parties and make a determination that
shall be binding upon the parties or (b) a process for seeking a
determination from the applicable regulatory authority, which
determination shall be binding upon the parties. Notwithstanding the
foregoing, in the event that an applicable regulatory authority rejects
BB's application as deficient with respect any of the matters for which
ImmunoGen is responsible pursuant to Clause 21.2, above, then ImmunoGen
shall not be entitled to dispute whether the data and documents are
deficient.
22 SUPPLY FOR CLINICAL DEVELOPMENT PURPOSES
22.1 ESTIMATES. ImmunoGen and BB shall cooperate, through the Collaboration
Committee, in estimating the volume of Licensed Compound required from
time to time by BB or Sub-licensees during Clinical Development.
22.2 SUPPLY OBLIGATIONS. During the Clinical Development phase, ImmunoGen
shall supply all of BB's required quantities of Licensed Compound for
Clinical Studies within a reasonable period of receipt of an order from
BB provided that such order is in accordance with the estimated volumes
agreed pursuant to Clause 22.1 for Licensed Compound for such Clinical
Study and
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further ImmunoGen shall use reasonable commercial efforts to ensure
continuity of supply of Licensed Compound during the Clinical
Development phase. All such supplies of Licensed Compound during the
Clinical Development phase shall be in conformity with the
Specifications. Following the grant of Regulatory Approval for Product
for the treatment of a particular indication within the Field, the
supply provisions set out in Clause 24 shall apply; provided always
that to the extent that Clinical Development of Licensed Compound is
ongoing for other indications within the Field the provisions of this
Clause shall apply to supply therefor.
22.3 CHANGE TO PRODUCTION PROCEDURE ETC. The parties recognize that in order
to optimize the production procedure for commercial purposes, changes
and modifications are expected to be required during the Clinical
Development phase. It is further acknowledged that it is the parties'
intention that the manufacturing production process for commercial
purposes should be formalized [*]. If ImmunoGen decides that any change
or modification of the production procedure of the Licensed Compound is
necessary during the term for any reason or if any changes to
manufacturing facilities, equipment (except to the extent that changes
are made as a result of routine maintenance) or quality control
procedures are proposed, ImmunoGen shall promptly notify BB in writing
of the need for such change or modification. To the extent that any
change or modification is material, ImmunoGen shall not implement such
change or modification to the actual production procedure without BB's
prior written consent, which shall not be unreasonably withheld and
shall be deemed given unless ImmunoGen is otherwise notified in writing
by BB within [*] of ImmunoGen's corresponding notice. It is agreed that
it shall be reasonable for BB to withhold its consent to any changes
which may materially impact on BB's ability to apply for Regulatory
Approvals in the Territory or which would result in a material
interruption in the supply of Licensed Compound or Product. To the
extent that any material changes are made to the manufacturing process,
ImmunoGen shall carry out, [*], all necessary pre-clinical work to
minimize the need for clinical comparability studies to be conducted,
provided always that in the event that the Regulatory Authorities
require any such clinical comparability studies to be so conducted,
these shall be conducted [*]t. Furthermore, in the event that any
changes result [*].
22.4 PRICE AND PAYMENT. Those amounts of Licensed Compound required by BB to
carry out Clinical Studies in the Territory and the USA during the
Clinical Development phase shall be supplied by ImmunoGen to BB at [*]
(as defined below). Payment in respect of the supply of any Licensed
Compound shall be made within [*] of receipt of the appropriate invoice
by BB and shall be paid in the currency in which the invoice provides.
For the purposes of this Clause, the [*] shall mean [*]. To the extent
that any [*]
[*]
22.5 IMPORT APPROVALS. BB shall be responsible for ensuring that the
appropriate approval has been obtained for, and to manage, the
importation of Licensed Compound for such Clinical Study within that
part of the Territory into which such Licensed Compound is to be
imported. ImmunoGen shall supply all necessary documentation reasonably
requested by BB to obtain consent to import Licensed Compound required
during the Clinical Development phase and provide all reasonable
assistance required to enable Licensed Compound to be imported into
that part of the Territory in which it is required.
22.6 LABELING. The parties shall, through the Collaboration Committee,
cooperate to ensure that Licensed Compound for any Pre-Clinical Study
or Clinical Study is appropriately labeled.
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22.7 PROVISION OF RECORDS. Each shipment of Licensed Compound shall be
accompanied by certified copies of its batch records, environmental
controls records and a certificate of analysis issued and signed by the
person responsible for the Quality Control Unit (or nominated deputy)of
ImmunoGen confirming or detailing, amongst other things, (i) the
company issuing such certificate; (ii) the product and batch; (iii) a
list of all tests conducted on the Licensed Compound together with the
acceptance limits for each test; and (iv) that such shipment complies
with the Specification. The Collaboration Committee shall agree any
other requirements for the certificate of analysis as soon as
reasonably practicable.
22.8 SHIPMENTS. ImmunoGen shall promptly notify BB of the shipments of
Licensed Compound during the Clinical Development phase. Such shipments
shall be sent at [*] to such place of delivery as BB shall specify to
meet any agreed delivery dates, which expense shall [*].
22.9 SAFETY DATA To the extent that any new safety data is generated by
ImmunoGen it shall promptly notify BB and the Collaboration Committee
shall agree upon the appropriate actions to be taken and the
preparation and circulation of appropriate safety data sheets to
relevant parties.
23 NON-CONFORMING CLINICAL SUPPLIES
23.1 NONCONFORMING CLINICAL SUPPLIES. Within [*] after the delivery of
Licensed Compound and the accompanying certificate of analysis to BB,
BB shall submit to ImmunoGen in writing any claim that such Licensed
Compound does not conform with the Specifications, accompanied by a
report of BB's analysis (which analysis shall be conducted in good
faith) and a sample of the Licensed Compound at issue, explaining in
reasonable detail the basis on which the allegedly nonconforming
Licensed Compound does not meet the Specifications. BB shall not be
obligated to pay for such nonconforming shipment of Licensed Compound.
Only those tests listed in the Specifications may be used to
demonstrate nonconformance of Licensed Compound.
23.2 REPLACEMENT; CANCELLATION; SETTLEMENT. ImmunoGen shall conduct its own
analysis of the sample in good faith within [*] after the receipt by
ImmunoGen of the report and sample from BB, and provide the results to
BB. If after ImmunoGen's own analysis of the sample ImmunoGen agrees
with the claim of nonconformity, BB shall promptly inform ImmunoGen if
BB wishes to have ImmunoGen replace the nonconforming Licensed Compound
with conforming Licensed Compound. If BB wishes to receive such
replacement Licensed Compound, ImmunoGen shall provide such replacement
as soon as reasonably practicable thereafter, in which case BB shall be
obligated to pay only for such replacement Licensed Compound. BB shall
not be obligated to pay for the nonconforming Licensed Compound, and
ImmunoGen shall: (i) credit BB for the amount paid by BB for the
nonconforming Licensed Compound if BB has already paid for such
nonconforming Licensed Compound or (ii) cancel its invoice to BB for
such nonconforming Licensed Compound if BB has not yet paid for such
nonconforming Licensed Compound, and BB shall not be obligated to pay
such canceled invoiced amount. If, after its own analysis, ImmunoGen
does not agree with the claim of nonconformity or determines that BB is
responsible for the nonconformity, the Parties shall in good faith
discuss and agree upon a settlement of the issue, and BB shall not be
obligated to pay for such alleged nonconforming Licensed Compound until
such settlement is reached.
23.3 RETURN OR DESTRUCTION OF NON-CONFORMING STOCK. After ImmunoGen has
agreed that the Licensed Compound shipment is nonconforming, and if
ImmunoGen is responsible for the nonconformity, BB shall return or
destroy it at ImmunoGen's request and cost in the most cost effective
and environmentally safe and appropriate manner available, consistent
with all relevant laws and regulations.
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24 COMMERCIAL MANUFACTURE AND SUPPLY OF PRODUCT
24.1 PRODUCT FOR COMMERCIAL SALE. ImmunoGen shall retain responsibility for
the commercial Manufacture and supply of Licensed Compound and/or
Product to BB until the termination or expiration of this Agreement,
which Manufacture and supply shall be in accordance with all Regulatory
Approvals granted, and all laws and regulations in force, in each
country within the Territory. ImmunoGen shall use commercially
reasonable efforts to manufacture for and supply to BB all of BB's
requirements for Product in accordance with the terms of any agreement
to be agreed between the parties taking in accordance with the terms
attached to this Agreement as Schedule 4 ("Supply Agreement"). The
price to BB for commercial supply of Product shall be [*].
24.2 Subject to Clause 27 below, during the term of this Agreement, BB shall
purchase all its requirements for Product from ImmunoGen. Upon BB's
request, during the[*] period preceding the expiration of the term of
this Agreement, the parties agree to negotiate in good faith for an
extension of supply by ImmunoGen and purchase of the Product by BB.
25 CONTRACT MANUFACTURING
25.1 ImmunoGen may contract with one or more contract manufacturers to
perform any or all of its Manufacture obligations under this Agreement
and the Supply Agreement, provided that (i) ImmunoGen incorporates all
relevant provisions of this Agreement into any arrangements it enters
into with contract manufacturers after the Effective Date (each a
"Contract Manufacturer Agreement"), and (ii) ImmunoGen provides BB with
a true and accurate copy of each such Contract Manufacturer Agreement.
25.2 ImmunoGen agrees to use its commercially reasonable efforts to include
in each Contract Manufacturer Agreement the following provisions: (i) a
prohibition against sublicensing by such contract manufacturer of
Licensed IP licensed to such Contract Manufacturer by ImmunoGen; (ii) a
prohibition against the sale by such contract manufacturer to any
Independent Third Party of (A) Licensed Compound for use in any product
to be sold or distributed in the Territory or (B) Product for resale
(other than by ImmunoGen to BB, or by BB itself) in the Territory, and
(iii) a right for ImmunoGen to terminate such Contract Manufacturer
Agreement in the event of a breach of the terms set forth in either of
(i) or (ii) above.
25.3 ALTERNATE SUPPLY. ImmunoGen agrees to use commercially reasonable
efforts to cause at least one further source of supply of Licensed
Compound (in addition to its primary source of supply) to become and
remain pre-qualified as soon as practicable after the first Regulatory
Approval is granted in the Territory and during the remainder of the
term of this Agreement.
26 RETENTION OF RECORDS
26.1 RECORDS. ImmunoGen shall maintain, and shall cause its Affiliates,
sub-contractors or other agents to maintain, all records necessary to
comply with applicable laws, rules and regulations relating to the
manufacture and storage of Licensed Compound and the Product (in bulk
or finished form). All such records shall be maintained for such period
as may be required by law, rule or regulation; provided, however, that
all records relating to the manufacture, stability and quality control
of each batch or partial batch of the Product shall be retained at
least until the first anniversary of the end of the approved shelf life
for all Product from such batch or partial batch; and provided further
that neither party shall destroy such records without first notifying
the other
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party and giving the other party an opportunity to take control of such
records if the party being notified believes that applicable law or its
own written corporate policy requires such records to be maintained.
27 IMMUNOGEN'S INABILITY TO SUPPLY
27.1 INABILITY TO SUPPLY. If ImmunoGen fails for any reason, either during
the term of this Agreement or following its expiry, other than for a
force majeure event described in Clause 65, to deliver Licensed
Compound and/or Product to BB, then BB shall have the right to make or
have made all of its requirements of Licensed Compound and/or Product
and all such licenses as may be required by BB to conduct such
manufacture shall automatically be deemed to be granted to BB by
ImmunoGen; provided that BB shall not have the right to manufacture if,
[*] days after BB first notifies ImmunoGen of its intent to exercise
its rights under this Clause, ImmunoGen provides BB with a plan to cure
the inability to supply within the next [*] and then does so within
such [*] period. In addition to the other remedies provided for with
respect to any failure to supply the Product, the Supply Agreement
shall set forth a mechanism by which ImmunoGen will transfer to BB,
upon request, such Manufacturing Information, technology and know-how
(not already in BB's possession) so as to permit BB to manufacture
Product and/or Licensed Compound, and ImmunoGen agrees to cooperate
with BB to facilitate the transition. Notwithstanding the foregoing, if
ImmunoGen provides BB with notice of its ability to once again supply
BB with its requirements of Licensed Compound and/or Product, the
parties shall meet to discuss whether BB requires ImmunoGen to
recommence all or any part of supply of Licensed Compound or Product to
it.
28 REGULATORY COMPLIANCE AND REPORTING
28.1 GOVERNMENT INSPECTION. ImmunoGen agrees to advise BB by telephone and
facsimile immediately of any proposed or announced visit or inspection,
and as soon as possible but in any case within [*] of any unannounced
visit or inspection, by any Regulatory Authority of any facilities used
by or on behalf ImmunoGen in the performance of its obligations under
this Agreement, including the processes or procedures used at such
facilities in the manufacture of Licensed Compound or Product.
ImmunoGen shall provide BB with a reasonable description of each such
visit or inspection promptly (but in no event later than [*] calendar
[*]) thereafter, and with copies of any letters, reports or other
documents (including Form 483's) issued by any such authorities that
relate to Licensed Compound, Product, or such facilities, processes or
procedures. BB may review ImmunoGen's responses to any such reports and
communications, and if practicable, and, insofar as timely received,
BB's reasonable views and requests shall be taken into account prior to
submission of such reports and communications to the relevant
Regulatory Authority.
28.2 NOTIFICATION AND RECALL. If any Regulatory Authority issues or requests
a recall or takes similar action in connection with Licensed Compound
or the Product, or if either party determines that an event, incident
or circumstance has occurred which may result in the need for a recall
or market withdrawal, the party notified of or wishing to call such
recall or similar action shall, within [*], advise the other party of
notification or its determination by telephone or facsimile, after
which the parties shall promptly discuss and work together to effect an
appropriate course of action; provided, however, that either party may
initiate a recall or market withdrawal thereafter if it deems such
action necessary or appropriate. ImmunoGen shall be responsible for
notification to applicable Regulatory Authorities outside the Territory
and compliance with applicable laws outside the Territory in conducting
such recall. BB shall be responsible for notification to the
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applicable Regulatory Authorities with respect to countries in the
Territory and compliance with applicable laws in the Territory in
conducting such recall.
28.3 RECALL EXPENSE. If a recall results from the breach of a party's
warranties or obligations under this Agreement, the breaching party
shall bear the full expense of both parties incurred in any such
recall. Such expenses of recall shall include, without limitation, the
expenses of notification and destruction or return of the recalled
Product and the sum paid for the recalled Product. In the event,
however, that a recall is partially caused by both parties' actions or
omissions, then each party shall be responsible for its proportionate
share of the recall expenses based on its proportionate share of
causation.
28.4 REGULATORY COMPLIANCE. ImmunoGen shall ensure that any Licensed
Compound and/or Product packaging (together with any inserts or
material relating to the sale of Licensed Compound and/or Product)
which is Manufactured by or on its behalf and supplied to BB complies
with all relevant regulatory requirements in the Territory or any part
thereof. Furthermore, to the extent permitted by relevant laws and
regulations, BB shall ensure that Product sold in the Territory shall
contain a clear and prominent statement that Licensed Compound and/or
Product is sold under a license from ImmunoGen.
29 AUDIT RIGHTS OF BB
29.1 AUDIT OF RECORDS. ImmunoGen shall, and shall procure that any
sub-contractors or agents shall, keep at its usual place of business
complete and proper records and books of account showing the quantity
and COGS of Licensed Compound and/or Product Manufactured and supplied
whether inside or outside the Territory. Upon [*] prior written notice
from BB, ImmunoGen shall permit an independent certified public
accounting firm of nationally recognized standing selected by BB and
approved by ImmunoGen (such approval not to be unreasonably withheld or
delayed) at BB's expense, to examine pertinent books and records of
ImmunoGen, its sub-contractors or agents at their respective usual
places of business as may be reasonably necessary to verify the
accuracy of the price payable for clinical supplies or COGS in respect
of commercial supplies hereunder and ImmunoGen shall procure the
cooperation of its sub-contractors or agents in this regard. The
provisions of Clauses 12.1, 12.2 and 12.3 shall equally apply with
regard to the rights and obligations of the parties in connection with
audits under this Clause.
29.2 AUDIT OF FACILITIES. BB, or at BB's choice a third party auditor agreed
with ImmunoGen, shall be entitled to audit ImmunoGen's, or any
authorized sub-contractors', premises and processes for compliance with
the principles of GMP, and to audit the validation of facilities,
equipment, and production and tests to ensure their suitability for the
particular stage of development. ImmunoGen shall procure that BB has
equivalent rights to audit any additional approved sub-contractor(s)
that may be appointed by ImmunoGen. At BB's option, a written
questionnaire may be substituted for an audit. Audits may be made
before commencement of the operations specified in this Agreement,
during their execution and/or upon completion of such activities. Such
audit or audits shall be during normal plant or laboratory working
hours, and shall be on a date or dates agreed between the parties.
Under normal circumstances BB shall not audit ImmunoGen more than once
a year, however additional audits may be requested:
29.2.1 in the event of major process or facility change, to verify
corrective actions for significant deficiencies identified in
prior audits; or
29.2.2 in the event of process failures.
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In all cases BB shall provide a copy of any audit report to ImmunoGen.
ImmunoGen shall provide a response to the report within [*] of receipt
thereof, including a description of agreed corrective actions plus a
timetable for their implementation.
PART F - COMMERCIALIZATION PROVISIONS
30 BB'S DILIGENCE OBLIGATIONS
30.1 BB warrants and undertakes that it shall, at BB's expense, use
reasonable commercial efforts to diligently develop Licensed Compound
and obtain Regulatory Approval for the Product in the Territory and to
promote, market and sell Product in the Territory. The parties
acknowledge and agree that, subject to the terms of this Agreement, all
business decisions including, without limitation, decisions relating to
BB's research, development, registration, manufacture, sale,
commercialization, design, price, distribution, marketing and promotion
of Licensed Compound and/or Product covered under this Agreement and
relating to the Territory, shall be within the sole discretion of BB.
ImmunoGen acknowledges that nothing in this Agreement shall be
construed as imposing on BB the duty to market and/or sell and exploit
Product for which royalties are payable hereunder to the exclusion of,
or in preference to, any other product of comparable potential, or in
any way other than in accordance with its normal commercial practices.
The parties further acknowledge that the use of Independent Third Party
contractors in connection with obtaining Regulatory Approvals and/or
marketing of Product may facilitate the performance of such activities,
and that BB shall have the right, in its sole discretion, to utilize
Independent Third Party contractors for such purposes and to grant
appropriate sublicenses to such Independent Third Party subcontractors,
provided that BB first complies with the sublicensing obligations set
forth in Clause 3.
30.2 If, in ImmunoGen's reasonable opinion, BB fails to comply with any of
its diligence obligations under Clause 30.1, then, without limiting any
other remedies that may be available to ImmunoGen, ImmunoGen shall have
the right to give BB written notice thereof stating in reasonable
detail the particular failure(s). BB shall have a period of [*] from
the receipt of such notice to correct the failure or, in the event that
the failure cannot be reasonably cured within a [*] period, then BB
shall initiate actions reasonably expected to cure the failure within
[*] days of receiving notice and shall thereafter diligently pursue
such actions to cure the failure, even if requiring longer than the
time period specified in Clause 46. In the event of a dispute as to
whether or not BB has failed to exercise due diligence under Clause
30.1, or whether BB is diligently pursuing actions reasonably expected
to cure such failure under this Clause, such dispute shall be resolved
in accordance with Clause 51.
30.3 In addition to the provisions of Clause 65, the diligence obligations
of BB with respect to Product under this Agreement are expressly
conditioned upon the continuing absence of any adverse condition or
event which warrants a delay in Product commercialization including,
but not limited to, an adverse condition or event relating to Product
safety or efficacy or unfavorable labeling, pricing or pricing
reimbursement approvals, or lack of Regulatory Approval, and the
obligation of BB to develop or market Product shall be delayed or
suspended so long as in BB's reasonable opinion any such condition or
event exists. In the event that the parties disagree as to whether any
such condition or event exists or is continuing, the matter shall be
referred to the Collaboration Committee. If the Collaboration Committee
is unable to resolve the matter within
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[*] of the submission of the matter to it for resolution, the matter
shall be resolved in accordance with Clauses 51 and 52.
31 OBTAINING REGULATORY APPROVAL IN THE TERRITORY
31.1 BB shall be responsible, at its cost, for obtaining Regulatory Approval
for Product in the Field in the Territory where there is adequate
clinical data to support Regulatory Approval from each competent health
authority in the Territory.
31.2 Each Regulatory Approval and each pricing and reimbursement approval in
the Territory shall be placed in BB's name or the name of BB's
Affiliate(s) unless applicable law requires, or ImmunoGen and BB
otherwise agree, that an approval be solely or jointly in the name of
ImmunoGen or a designated ImmunoGen Affiliate. ImmunoGen agrees that
notwithstanding such Regulatory Approval or pricing and reimbursement
approval in its name, BB remains solely responsible for and retains the
exclusive rights to import, export, keep (whether for disposal or
otherwise), market, distribute, use, promote, offer for sale and sell
Licensed Compound and/or Product as granted to BB under the terms of
this Agreement.
31.3 BB agrees that, prior to the commencement of any appropriate pivotal
Agreed Clinical Study(ies) (as set out in the Development Plan), it
shall consult with the EMEA and/or the FDA to determine whether such
regulatory body is of the opinion that should such study(ies) meet its
primary protocol objective, when considered in conjunction with the
clinical data existing at that time, such combined data would be
reasonably sufficient to gain Regulatory Approval.
31.4 ImmunoGen shall provide BB, at BB's expense, with such assistance in
obtaining Regulatory Approval for Product as may be reasonably
requested by BB, including all reasonable assistance in relation to the
preparation and submission of Regulatory Approval dossiers to the
regulatory authorities and the response to questions posed by such
authorities, in respect of any Pre-Clinical Studies conducted by
ImmunoGen, CMC Development, Manufacture or such other data that has
been generated by ImmunoGen. ImmunoGen shall provide all such
assistance to enable BB to respond to the Regulatory Authorities in
accordance with any timetable that BB may set for filing such a
response.
31.5 Each party shall keep the other party fully informed of all its
interactions with Regulatory Authorities including the provision of all
material submissions, minutes of any meetings and all relevant
correspondence from the Regulatory Authorities.
31.6 BB shall take all commercially reasonable steps to maintain, at its
cost, and to comply with all necessary regulatory requirements relating
to the maintenance of, any Regulatory Approval granted for Product in
the Field in the Territory.
32 REGULATORY APPROVALS OUTSIDE THE TERRITORY
32.1 It is acknowledged that with regard to obtaining Regulatory Approvals
in countries outside the Territory, the general expectation is that
such applications will be based upon either upon an application for
Regulatory Approval or a Regulatory Approval filed with either the FDA
or the EMEA ("Primary Dossiers"). Schedule 6 sets out a summary of the
parties' current understanding with regard to ImmunoGen's ability to
rely on Primary Dossiers outside the Territory.
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32.2 In recognition of the fact that ImmunoGen will be relying on data,
Technical Information and/or Primary Dossiers generated by BB, BB shall
provide ImmunoGen, at ImmunoGen's expense, with such assistance in
obtaining Regulatory Approval for Product outside the Territory as may
be reasonably requested by ImmunoGen, including all reasonable
assistance in relation to the preparation and submission of Regulatory
Approval dossiers to the Regulatory Authorities and the response to
questions posed by such authorities, in respect of any Agreed Clinical
Studies, Technical Information, Primary Dossiers or other data that has
been generated by BB. BB shall provide all such assistance to enable
ImmunoGen to respond to the Regulatory Authorities in accordance with
any timetable that ImmunoGen may set for filing such a response.
32.3 It is further agreed that to the extent that any Regulatory Authority
outside the Territory requires ImmunoGen to conduct local Clinical
Studies (with the exception of the USA, where the conduct of Agreed
Clinical Studies shall be the responsibility, and at the cost, of BB)
or Commercialization Studies to support any application for Regulatory
Approval, such studies shall be the responsibility of ImmunoGen at its
cost. It is specifically acknowledged that in the event that ImmunoGen
applies for Regulatory Approval in China, due to the recognized
physiological differences that exist in the Chinese population, local
Clinical Studies and/or Commercialization Studies are likely to be
required.
32.4 In recognition of the fact that payment of the fee by ImmunoGen
pursuant to Clause 10.2 is dependant on the grant of a BLA in the USA,
ImmunoGen agrees that, following the generation of sufficient data from
the Agreed Clinical Studies, it will use reasonable commercial efforts
to apply for and obtain Regulatory Approval for Product in the USA
32.5 To the extent reasonably required, BB will provide ImmunoGen, at
ImmunoGen's cost, with advice and assistance in the design of any local
Clinical Studies or Commercialization Studies that ImmunoGen is
required to conduct outside the Territory.
33 MARKETING AND SALE OF PRODUCT
33.1 AGREEMENT OF MARKETING PLAN. Commencing in the year in which either BB
files an application for Regulatory Approval in any of the Major EU
Markets or ImmunoGen files an application for Regulatory Approval in
the USA, but in any event no earlier than [*] after such filing, the
parties shall, via the Collaboration Committee, meet to agree a
marketing plan to coordinate the worldwide commercialization (to the
extent legally permissible in accordance with applicable anti-trust
legislation in and outside the Territory) for Product which shall
include the following information:
33.1.1 a sales target in respect of the sale of Product;
33.1.2 anticipated or actual pricing of Product, as applicable, on a
country-by-country basis in each geographic market;
33.1.3 the branding and labeling of Product, which it is intended
shall be consistent across all countries in which Product is
marketed by the parties to the extent reasonably practicable
in all the circumstances;
33.1.4 the proposed detailing to be assigned to the sale of Product;
and
33.1.5 the major marketing programs and marketing assumptions;
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(referred to as the "Marketing Plan").
33.2 ANNUAL UPDATES. The Marketing Plan shall be updated annually thereafter
in the fourth calendar quarter of each year and in this respect the
parties shall meet, via the Collaboration Committee, to agree any
revisions thereto.
33.3 OTHER AMENDMENTS. It is agreed that:
33.3.1 the Marketing Plan may be subject to amendments, adjustments
and/or revisions by the parties to take into account current
market conditions and/or any events which may occur during the
period to which the Marketing Plan relates provided always
that amending party shall notify the Collaboration Committee
as soon as reasonably practicable in the event that such party
proposes to make any such amendment, adjustment or revision;
and
33.3.2 to the extent that any changes are made to the Marketing Plan
which have not been notified to the Collaboration Committee
pursuant to Clause 33.3.1, they shall be discussed and
explained at the annual meetings to take place between the
parties pursuant to Clause 33.2.
33.4 INTENTION TO OUT-LICENSE. In the event that either party elects to
license an Independent Third Party to conduct the marketing and sale of
Product in the whole of its territorial market it shall notify the
other party. If both parties agree that the Product should be
out-licensed to an Independent Third Party for the relevant indication
on a worldwide basis the parties agree to cooperate, through the
Collaboration Committee, in the identification of a suitable
pharmaceutical entity to conduct such worldwide commercialization on
their behalf. If after [*] (or such longer period as may be agreed by
the Collaboration Committee at the time), the parties have been unable
to interest a suitable pharmaceutical entity, and encourage such entity
to submit preliminary business terms, or if both parties decide that
any terms so submitted are unacceptable to them, each of BB and
ImmunoGen shall be entitled, in their sole discretion, to appoint a
licensee or licensees in respect of their respective territories or
part thereof. If both parties decide that the terms are acceptable, it
is agreed that [*]
33.5 BB's FIRST RIGHT TO NEGOTIATE. In the event that ImmunoGen elects to
appoint a licensee in any country(ies) outside the Territory and BB
intends to commercialize Product in the Territory, ImmunoGen agrees to
grant BB first right to enter discussions with it with regard to BB
being licensed to commercialize Product in such country(ies) outside
the Territory. If after [*] good faith negotiations, ImmunoGen
reasonably determines that BB would not be a suitable licensee, it
shall be entitled to initiate discussions with Independent Third
Parties.
33.6 ImmunoGen's FIRST RIGHT TO NEGOTIATE. In the event that BB elects to
appoint a licensee in any country(ies) of the Territory and ImmunoGen
intends to commercialize Product outside the Territory, BB agrees to
grant ImmunoGen first right to enter discussions with it with regard to
ImmunoGen being licensed to commercialize Product in such country(ies)
in the Territory. If after [*] good faith negotiations, BB reasonably
determines that ImmunoGen would not be a suitable licensee, it shall be
entitled to initiate discussions with Independent Third Parties.
34 TRADE MARKS
34.1 To the extent reasonably practicable and allowable, the parties shall
endeavor to ensure that that marketing and selling of Product shall
occur under the same trade marks and logos both in and outside the
Territory it being agreed that BB shall be the owner of any such trade
marks or logos
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WITH THE SECURITIES AND EXCHANGE COMMISSION
in the Territory and ImmunoGen shall be the owner of any such trade
marks or logos outside the Territory. To the extent that it is not
possible for Product to be marketed and sold under a global trade xxxx
or logo, BB shall be entitled to select its own trade marks and logos
in the Territory and ImmunoGen shall be entitled to select its own
trade marks outside the Territory.
PART G - PATENT PROVISIONS
35 PATENT PROSECUTION AND MAINTENANCE
35.1 ImmunoGen, [*], shall file, prosecute and do all such acts and things
as may be reasonably necessary to obtain the grant of the Patents for
their full term. In addition, ImmunoGen, [*] shall file and prosecute
applications for patents covering any ImmunoGen Improvement that it
adjudges in its reasonable opinion has potential commercial application
and that constitutes a ImmunoGen Improvement or a Joint Improvement in
accordance with the following principles:
35.1.1 applications shall be filed expeditiously at the appropriate
time in all countries in which ImmunoGen in its absolute
discretion considers that patent protection for a ImmunoGen
Improvement or a Joint Improvement is necessary or desirable;
35.1.2 ImmunoGen shall notify BB of its proposed filing list at least
[*] prior to the deadline for filing; and
35.1.3 in the event that BB wishes a patent application to be filed
in respect of the said ImmunoGen Improvement or Joint
Improvement in a particular country that does not appear upon
ImmunoGen's filing list it shall request the addition of such
country to ImmunoGen's filing list. If ImmunoGen refuses to
include such country in the said list [*] . ImmunoGen shall
allow BB to apply for patent protection in its own name in
respect of such country and shall allow BB to take the benefit
of ImmunoGen's priority date and, [*] give all reasonable
assistance required by BB.
For purposes of clarity the parties acknowledge and agree that patent
applications claiming ImmunoGen Improvements or Joint Improvements
filed pursuant to this Clause, and any patents issuing therefrom, shall
be included in the definition of Patents.
35.2 At BB's request, ImmunoGen shall,[*] provide BB with copies of:
35.2.1 granted Patents;
35.2.2 pending applications for Patents and amendments thereto; and
35.2.3 such material correspondence to and from patent offices within
the Territory concerning pending applications for Patents to
allow for review by, and consultation with, BB reasonably in
advance of any submission to a patent office which could
materially affect the scope or extent or validity of any
Patent that may result.
35.3 Save as provided in Clause 35.4, ImmunoGen shall during the term of
this Agreement [*] and do all such acts and things as may be reasonably
necessary to maintain any granted Patents for their full term in any
part of the Territory.
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35.4 In the event that ImmunoGen intends to abandon any of the Patents or
allow any of the Patents to lapse in any part of the Territory, it
shall notify BB in writing of such intention at least [*] prior to such
proposed abandonment or lapse and offer BB an opportunity to acquire
such Patents to the extent they apply to such part of the Territory for
nominal consideration. BB shall have a period of[*] days to respond to
such written offer by ImmunoGen. In the event that no response is
received from BB within such thirty [*] period, ImmunoGen shall be
entitled to allow such Patents to become abandoned or lapse without
further notice to BB. In the event that BB does elect to acquire the
Patent(s), ImmunoGen shall, [*] give all reasonable assistance required
by BB to assign all rights relating to any such Patent(s) which shall
thereafter not be considered Patents under this Agreement and ImmunoGen
shall have no further rights or obligations with respect thereto,
provided that in the event that this Agreement is terminated, except
for any termination by BB under Clause 46 for material breach by
ImmunoGen, BB will grant ImmunoGen a royalty-free non-exclusive license
thereunder.
35.5 Unless the term of any Patent has already been extended by ImmunoGen at
the time of the granting of Regulatory Approval in a particular part of
the Territory, ImmunoGen shall be entitled to apply in such part of the
Territory for an extension of the term of any such Patent(s) capable of
extension in such part of the Territory. In this event, BB shall, and
shall use reasonable endeavors to procure that any Sub-licensees shall,
make available to ImmunoGen [*] all relevant documentation and other
materials which may be in the possession or under the control of BB or
Sub-licensees which in ImmunoGen's reasonable opinion are necessary to
procure such extension. If in order to obtain such extension it is in
ImmunoGen's reasonable opinion necessary for BB to join with ImmunoGen
in making the application for extension, BB shall at [*] promptly do so
and shall fully cooperate with ImmunoGen in connection with any such
application.
35.6 ImmunoGen shall provide BB or BB's nominated agent with an annual
status report of patent applications filed by ImmunoGen under this
Clause 35. In addition, ImmunoGen shall promptly notify BB in writing
in the event that ImmunoGen becomes aware of any facts, information or
circumstances that may cause any of the Patents to be deemed invalid or
unenforceable, in whole or in part, and shall thereafter undertake
diligent efforts to defend the validity and enforceability of such
Patents.
36 INVENTIONS OF BB
36.1 BB, [*], shall file and prosecute applications for patents covering any
BB Improvement that it adjudges in its reasonable opinion has potential
commercial application and that constitutes a BB Improvement in
accordance with the following principles:
36.1.1 applications shall be filed expeditiously at the appropriate
time in all countries in which BB in its absolute discretion
considers that patent protection for a BB Improvement is
necessary or desirable;
36.1.2 BB shall notify ImmunoGen of its proposed filing list at least
[*] prior to the deadline for filing;
36.1.3 In the event that ImmunoGen wishes a patent application to be
filed in respect of the said BB Improvement in a particular
country that does not appear upon BB's filing list it shall
request the addition of such country to BB's filing list. If
BB refuses to include such country in the said list then [*]
BB shall allow ImmunoGen to apply for patent protection
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CONFIDENTIAL TREATMENT REQUESTED.
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in its own name in respect of such country and shall allow
ImmunoGen to take the benefit of BB's priority date and, [*],
give all reasonable assistance required by ImmunoGen; and
36.1.4 BB shall not abandon any such patent application or permit any
patent issuing therefrom to lapse without first having given
to ImmunoGen at least [*] prior notice in writing of its
intention to permit such application to be abandoned or lapse
and permitting ImmunoGen to continue the prosecution or
maintenance of such application or patent (as appropriate).
ImmunoGen shall have[*] to respond to such written notice from
BB. In the event that no response is received from ImmunoGen
within such [*] period, BB shall be entitled to allow such
patent or patent application to become abandoned or lapse. In
the event that ImmunoGen does elect to acquire the patent or
patent application, BB shall [*] give all reasonable
assistance required by ImmunoGen to assign all rights relating
to any such patent application or patent to ImmunoGen to
enable it to prosecute or maintain the said patent application
or patent (as appropriate) which shall thereafter be
considered Patents under this Agreement and except as
expressly granted under this Agreement BB shall have no
further rights or obligations with respect thereto, provided
that in the event that this Agreement is terminated by BB
under Clause 46 for material breach by ImmunoGen, ImmunoGen
will grant BB a royalty-free non-exclusive license thereunder.
36.2 At ImmunoGen's request, BB shall, [*] furnish ImmunoGen with copies of:
36.2.1 granted patents obtained by BB pursuant to this Clause 36;
36.2.2 pending applications for such patents and amendments thereto;
and
36.2.3 such material correspondence to and from patent offices to
allow for review by, and consultation with, ImmunoGen
reasonably in advance of any submission to a patent office
which could materially affect the scope or extent or validity
of the patent that may result.
36.3 BB shall provide ImmunoGen or ImmunoGen's nominated agent with an
annual status report of patent applications filed by BB under this
Clause 36.
37 INFRINGEMENT AND INVALIDITY PROCEEDINGS
37.1 In the event that either BB or ImmunoGen becomes aware of any third
party infringement within the Territory of any Patents, it will notify
the other party in writing to that effect. Any such notice shall
include any evidence in the notifying party's possession to support an
allegation of infringement by such third party. ImmunoGen shall have a
period of [*] from the date of said notice to obtain a discontinuance
of such infringement and failing the obtaining of such discontinuance,
ImmunoGen shall have the right but not the obligation to bring legal
proceedings against the third party infringer. ImmunoGen shall bear all
the expenses of any suit brought by it (except to the extent otherwise
provided in this Clause 37).
37.2 In the event that ImmunoGen elects to bring suit against the third
party infringer, BB shall have the right, [*], to be represented in an
such action by ImmunoGen by counsel of BB's own choice; provided, that
under no circumstances shall the foregoing affect the right of
ImmunoGen to control the suit as described in Section 37.1.
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37.3 BB will reasonably cooperate with ImmunoGen in any such suit or action
and shall have the right to consult with ImmunoGen and be independently
advised by independent counsel, provided that ImmunoGen shall [*] with
ImmunoGen. ImmunoGen shall indemnify and hold BB harmless for any
monetary judgment or award against or penalty levied upon ImmunoGen or
BB arising out of ImmunoGen's acts in the enforcement of such Patents
except to the extent that any such monetary judgment award or penalty
is caused by the negligent acts or omissions of BB.
37.4 If ImmunoGen does not take any action within [*] after written notice
from BB of such infringement, then BB shall have the right, but not the
obligation, to bring suit against such infringer under the Patents and
to the extent required by law, join ImmunoGen as a party plaintiff,
[*](except to the extent otherwise provided in this Clause). ImmunoGen
will reasonably cooperate with BB in any such suit for infringement of
a Patent brought by BB against a third party, and shall have the right
to consult with BB and be independently advised by independent counsel
in such litigation [*]. [*] in cooperating with BB. BB shall incur no
liability to ImmunoGen as a consequence of such litigation or any
unfavorable decision resulting therefrom, including any decision
holding any of the Patents invalid or unenforceable, except that BB
shall indemnify and hold ImmunoGen harmless for any monetary judgement
or award against or penalty levied upon either ImmunoGen or BB arising
out of BB's acts in the enforcement of such Patents except to the
extent that any such monetary judgment award or penalty is caused by
the negligent acts or omissions of ImmunoGen.
38 THIRD PARTY INFRINGEMENT PROCEEDINGS
38.1 In the event that a third party sues BB alleging that BB's or its
Sub-licensees' importing, exporting, keeping (whether for sale or
otherwise), using, distributing, marketing, promoting, offering for
sale or selling Licensed Compound or Product in one or more countries
in the Territory infringes or will infringe said third party's patent,
the parties shall meet as soon as reasonably practicable to discuss the
future conduct thereof. If following such discussions:
38.1.1 ImmunoGen determines that it wishes to participate in the
conduct of such action, it is hereby agreed that [*].
38.1.2 ImmunoGen determines that it does not wish to participate in
the conduct of such action then [*].
38.2 Upon the institution of an action referred to in Clause 38.1,
[*].
38.3 [*].
38.4 [*]
39 MISCELLANEOUS PROVISIONS
39.1 The parties shall keep one another informed of the status of their
respective activities regarding any litigation or settlement thereof
concerning Licensed Compound or Product or any actual or threatened
infringement of the Patents.
39.2 Any damages obtained as a result of the proceedings contemplated by
Clause 37 [*]:
39.2.1 [*];
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39.2.2 [*]:
39.2.2.1 [*]
39.2.2.2 [*].
39.3 ImmunoGen shall promptly notify BB in writing in the event that
ImmunoGen becomes aware of:
39.3.1 any actual or potential claim by a third party alleging an
ownership interest in the Licensed IP or any actual or
potential liens, charges or encumbrances with respect to the
Licensed IP;
39.3.2 any information suggesting that the Licensed IP and the
development, manufacture, use, distribution, marketing,
promotion and sale of Licensed Compound and/or Product may
interfere or infringe on any intellectual property rights
owned or possessed by any Independent Third Party;
39.3.3 any pending or threatened claims or litigation against
ImmunoGen relating to Licensed Compound, Product or the
Licensed IP;
39.3.4 any circumstances that would render BB liable to an
Independent Third Party for patent infringement as a
consequence of BB's sale of the Licensed Compound or Product
or use of the Licensed IP; or
39.3.5 any Patents which have not been properly registered, or for
which applications for registration have not been properly
made, on behalf of and in the name of ImmunoGen as sole
proprietor, or of any grounds for refusing any existing
application for registration of any of the Patents.
Following such notice to BB, ImmunoGen shall provide BB with reasonable
assistance to resolve such situation in a manner reasonably acceptable
to BB and in accordance with the terms of this Agreement.
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WITH THE SECURITIES AND EXCHANGE COMMISSION
40 EFFECT OF INTERIM OR FINAL RESTRAINING ORDER OR INJUNCTION ON AGREEMENT
40.1 If at any stage an interim or final restraining order or interlocutory
injunction or similar order of the Court is granted whereby BB or
ImmunoGen is restrained from manufacturing, supplying, importing,
exporting, keeping (whether for disposal or otherwise), selling or
otherwise dealing with or in Licensed Compound and/or Product in a
particular part of the Territory then BB's obligations to
commercialize, use, sell, distribute and/or market, and ImmunoGen's
obligations to supply, Licensed Compound or Product in the Field in
such part of the Territory to which the said order or injunction
applies pursuant to this Agreement and to pay any future royalty or
other sums in connection therewith shall be suspended in respect of
such part of the Territory only.
40.2 The provisions of Clause 40.1 shall in no way affect BB's obligations
to pay ImmunoGen any accrued payments which relate to its activities
prior to any such order or injunction being granted or payments in
respect of any part of the Territory unaffected by the order or
injunction. In the event that any temporary restraining order or
injunction is removed, BB's obligations under this Agreement in respect
of such part of the Territory to which the order or injunction related
shall automatically recommence from the date that such removal is
effective.
41 FURTHER THIRD PARTY LICENSES
41.1 In the event that further patent licenses from third parties
(including, without limitation, those set out in Schedule 10) are
reasonably required by either (a) ImmunoGen in order for it to carry
out Pre-Clinical Studies, to fulfil its CMC Development obligations or
to Manufacture Licensed Compound or Product; or (b) BB or its
Sub-licensees in order to develop, import, export, keep (whether for
disposal or otherwise) use, distribute, promote, market, offer for sale
or sell Licensed Compound and/or Product (hereinafter "Further Third
Party Licenses"), [*]. Upon the conclusion of a Further Third Party
License, [*].
42 COMPULSORY LICENSES
42.1 If a compulsory license (as such term is construed pursuant to section
48 of the UK Patents Xxx 0000 as amended by the Patents and Trademarks
(World Trade Organization) Regulations 1999, or such equivalent
statutory provision in any other country of the Territory) is granted
under the Patents to an Independent Third Party with respect to
Licensed Compound and/or Product in any country in the Territory [*].
43 DIRECT AFFILIATE LICENSES
43.1 Whenever BB shall reasonably demonstrate to ImmunoGen that, in order to
facilitate direct royalty payments by an Affiliate, it is desirable
that a separate license agreement be entered into between ImmunoGen and
such Affiliate, ImmunoGen will grant such licenses directly to such
Affiliate by means of an agreement which shall be consistent with all
of the provisions hereof, provided that BB guarantees the Affiliate's
obligations thereunder.
PART H - TERMINATION PROVISIONS
44 BB'S RIGHT TO TERMINATE
44.1 BB shall have the right, but not the obligation, to terminate this
Agreement [*]
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44.1.1 [*];
44.1.2 [*]
44.1.2.1 [*]
44.1.2.2 [*]
44.1.2.3 [*].
44.1.3 [*]:
44.1.3.1 [*]
44.1.3.2 [*]
In the event that ImmunoGen disagrees that the opinion formed by BB in
Section 44.1.2 above is reasonable, the matter shall be referred to the
Collaboration Committee. If the Collaboration Committee is unable to
resolve the matter within [*] of the submission of the matter to it for
resolution, BB shall be entitled to terminate the Agreement and all
licensed rights shall return to ImmunoGen pursuant to the provisions of
Clause 47.2.
44.2 If in the reasonable opinion of BB, [*]
45 IMMUNOGEN'S RIGHTS TO TERMINATE
45.1 Save in the circumstances expressly referred to herein, in the event
that [*].
45.2 ImmunoGen shall have the right, but not the obligation, to terminate
this Agreement [*]:
45.2.1 [*]
45.2.2 [*]
46 GENERAL RIGHTS OF TERMINATION BY EITHER PARTY
46.1 INSOLVENCY. If at any time either party shall become insolvent or shall
cease to carry on its business or shall go into liquidation, whether
compulsory or voluntary (other than a voluntary liquidation for the
purpose of reconstruction or amalgamation), or shall have a receiver
appointed over the whole or any part of its assets or shall enter into
any arrangement or composition with its creditors or become bankrupt or
enter into a corporate rehabilitation or corporate reorganization then,
and in any of the foregoing events, the other party shall be entitled
to terminate this Agreement forthwith by notice in writing.
46.2 MATERIAL BREACH. This Agreement may be terminated by either party if
the other party is in breach of its material obligations hereunder and
has not cured such breach within [*] after written notice requesting
cure of the breach with reasonable detail of the particulars of the
alleged breach, or within [*] of receiving notice initiated actions
reasonably expected to cure the cited failure and thereafter diligently
pursued such actions to cure the failure (even if requiring longer than
the ninety [*] set forth in this subsection). To the extent that the
party receiving the notice
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disputes the existence of a material breach, the provisions of Clause
51 shall apply and the notice shall be suspended until the outcome
thereof.
47 EFFECT OF TERMINATION
47.1 GENERAL PROVISIONS. The termination of this Agreement either in whole
or in part shall:
47.1.1 be without prejudice to the accrued obligation of either party
to pay to the other party all sums due and payable either in
whole or in part, which sums shall be paid within forty five
(45) days of the date of termination;
47.1.2 be without prejudice to any right of, or remedy available to,
either party against the other in respect of anything done or
omitted hereunder prior to such termination; and
47.1.3 not release either party from the inability to supply,
confidentiality, non-solicitation, standstill or
indemnification obligations set forth in Clauses 27, 53, 55,
56 and 62 hereof.
47.1.4 not relieve BB or ImmunoGen from complying with the applicable
terms and conditions of this Agreement.
47.2 EFFECT OF TERMINATION[*] If this Agreement is terminated [*]:
47.2.1 [*];
47.2.2 [*];
47.2.3 [*];
47.2.4 [*];
47.2.5 [*]
47.2.6 [*].
47.3 EFFECT OF TERMINATION BY [*]. If this Agreement is terminated by[*]:
47.3.1 [*];
47.3.2 [*];
47.3.3 [*]
47.3.4 [*]
PART I - PUBLICITY AND PUBLICATION PROVISIONS
48 PUBLICITY
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48.1 Except as provided in Clause 53, a party may not use the name of the
other party in any publicity, advertising or in any other public way
and, may not issue press releases or otherwise publicize or disclose
any information related to the existence of this Agreement, the terms
or conditions of this Agreement, or any information relating to the
subject matter hereof, without the prior written consent of the other
party. The parties may agree upon an initial press release to announce
the execution of this Agreement, together with a corresponding Q&A
outline for use in responding to inquiries about the Agreement.
Following such initial press release, either party may use the specific
information contained therein, or in any subsequent public
announcements or publications made by the other party or by mutual
agreement of the parties, in its investor relations and public
relations activities. Neither party shall make public announcements,
either written, oral or in any medium relating to the safety of
Licensed Compound and/or Product, except for statements in official
correspondence with government patent authorities in support of Patents
as provided for in this Agreement. Nothing in the foregoing, however,
shall prohibit a party from making disclosures to the extent required
under applicable federal or state securities laws or any rule or
regulation of any nationally recognized securities exchange, provided
same is accurate and complete. In such event, however, the disclosing
party shall use good faith efforts to consult with the other party
prior to such disclosure and, where applicable, shall request
confidential treatment to the extent available.
49 PUBLICATIONS
49.1 BB and ImmunoGen each acknowledge the potential benefit in publishing
results of certain studies to obtain recognition within the scientific
community and to advance the state of scientific knowledge. Each party
also recognizes the mutual interest in obtaining valid patent
protection and in protecting business interests and trade secret
information. No publication of Manufacturing Information, Patents or
Technical Information or other Confidential Information (collectively,
"Protected Information") may be made without mutual written consent.
The parties agree that BB, its employees or consultants shall be free
to make any publication which does not disclose any of the Protected
Information. In the event that any proposed publication (as defined
below) discloses Protected Information, the following procedure shall
apply: Either party, its employees or consultants wishing to make a
publication shall deliver to the other party a copy of the proposed
written publication or an outline of an oral disclosure at least [*]
prior to submission for publication or presentation. For purposes of
this Agreement, the term "publication" shall include, without
limitation, abstracts and manuscripts for publication, slides and texts
of oral or other public presentations, and texts of any transmission
through any electronic media, e.g. any computer access system such as
the Internet, including the World Wide Web. The reviewing party shall
have the right (i) to propose modifications to the publication for
patent reasons, trade secret reasons or business reasons or (ii) to
request delay of the publication or presentation in order to protect
patentable information. If the reviewing party requests a delay, the
publishing party shall delay submission or presentation for a period
not less than [*] from the filing date of the first patent application
in the Territory covering the information contained in the proposed
publication or presentation. If the reviewing party requests
modifications to the publication, the publishing party may edit such
publication to prevent disclosure of trade secret or proprietary
business information prior to submission of the publication or
presentation. Following Regulatory Approval, BB shall have the right to
use any clinical data arising out of this Agreement, to the extent that
it relates to the Product(s) in respect of which Regulatory Approval
has been obtained.
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
PART J - DISPUTE PROVISIONS
50 GOVERNING LAW AND JURISDICTION
50.1 This Agreement shall be governed by and construed and interpreted in
accordance with the laws of the State of New York and the United States
without regard to that body of law known as conflicts of law; provided
that issues relating to the validity and enforceability of patents
shall be governed by the laws of the jurisdiction by which such patent
was granted. Any proceeding between the parties shall be conducted in
the English language.
51 DISPUTE RESOLUTION
51.1 In the event that a dispute arises between the parties as to the
interpretation or performance of any of the provisions of this
Agreement or as to matters related to but not covered by this
Agreement, the parties shall consult initially to try and resolve the
matter amicably. If they shall not be capable of resolving the matter
within [*]of the dispute arising, or such other period as may be
provided by this Agreement, it shall be referred to the respective
Chief Executive Officers or Chief Operating Officers of the parties.
51.2 If the Chief Executive Officers or Chief Operating Officers cannot
resolve the dispute within [*] days of it being referred to them, to
the extent that the parties mutually agree, the matter shall be
referred to binding or non-binding arbitration or mediation. Such
arbitration or mediation proceedings shall be held in Boston,
Massachusetts in the event that the dispute originated from BB and in
London, England in the event that the dispute originated from
ImmunoGen. To the extent that the parties do not mutually agree upon
the matter being referred to arbitration or mediation or to the extent
that the arbitration or mediation proceedings are non-binding and one
of the parties disputes the outcome thereof, the matter shall be dealt
with in accordance with the provisions of Clause 52.
52 LEGAL PROCEEDINGS
52.1 In the event that disputes between the parties have not been settled in
accordance with the provisions of Clause 51, the parties shall be
entitled to bring court proceedings in the Courts of New York, which
courts shall have the exclusive jurisdiction in respect thereof.
PART K - CONFIDENTIALITY, NON-SOLICITATION AND STANDSTILL PROVISIONS
53 CONFIDENTIALITY
53.1 During the term of this Agreement and, subject to the provisions of
Clause 4, for [*] thereafter, each party shall hold in confidence any
confidential information (including but not limited to Technical
Information, Manufacturing Information or BB Technical Information)
generated by the other party or received from the other party pursuant
to this Agreement ("Confidential Information") and shall not without
the prior written consent of the other party disclose any part of the
same to any Independent Third Party except such of its employees and
consultants and those of its Sub-licensees and contractors who have a
need to know in order to effect the work of the
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Development Plan or the obtaining of Regulatory Approval or marketing
of Product and who are bound by equivalent obligations of
confidentiality as those contained in this Clause.
53.2 BB and its Sub-licensees shall only use the Confidential Information
obtained from ImmunoGen in pursuit of its rights and obligations under
this Agreement including for the purposes of carrying out the
Development Plan or Marketing Plan in respect of Product.
53.3 ImmunoGen, its licensees and its contractors shall only use the
Confidential Information obtained from BB for the purpose of assisting
it in registering, marketing and selling Product outside the Territory.
53.4 The provisions of this Clause shall not apply to information received
by either ImmunoGen or BB or Sub-licensees hereunder which:
53.4.1 as of the date of receipt is in the public domain or comes
into the public domain through no breach of this Agreement by
the receiving party of any confidentiality obligation; or
53.4.2 is received at any time in good faith from a third party
lawfully in possession of the same and having no restriction
disclosing the same; or
53.4.3 was known to the receiving party prior to its receipt from the
disclosing party as can be demonstrated by the receiving party
through written evidence; or
53.4.4 is developed by the receiving party its Affiliate or
Sub-licensees without aid, application or use of any of the
Confidential Information to which the obligation of
confidentiality applies by employee(s) of the receiving party
who were not given access to the Confidential Information
received hereunder.
53.5 Nothing contained herein shall prevent:
53.5.1 BB from disclosing Confidential Information generated by or on
behalf of ImmunoGen for the purpose of procuring the requisite
Regulatory Approval from the appropriate authority and other
governmental agencies in the Territory for BB or Sub-licensees
to undertake clinical trials upon Product (including any
institutional review board of any Entity conducting clinical
studies) or to market Product in the Territory or any part
thereof; provided however that all reasonable steps are taken
to require the appropriate authority and said other
governmental agencies in the Territory or any part thereof to
treat the Confidential Information as confidential and
proprietary information of ImmunoGen; or
53.5.2 ImmunoGen from disclosing Confidential Information generated
by BB for the purpose of procuring the requisite Regulatory
Approval from the appropriate authority and other governmental
agencies outside the Territory for ImmunoGen to undertake
clinical trials upon Product (including any institutional
review board of any Entity conducting clinical studies) or to
market Product outside the Territory or any part thereof;
provided however that all reasonable steps are taken to
require the appropriate governmental agencies to treat the
Confidential Information as confidential and proprietary
information; or
53.5.3 Confidential Information that is required by law, regulation,
rule, act or order of any governmental authority or agency to
be disclosed by a party, provided that notice is promptly
delivered to the other party in order to provide an
opportunity to seek a
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
protective order or other similar order with respect to such
Confidential Information and thereafter the disclosing party
discloses to the requesting entity only the minimum
Confidential Information required to be disclosed in order to
comply with the request, whether or not a protective order or
other similar order is obtained by the other party.
53.6 The parties agree that the commercial and other terms of this Agreement
[*] shall, unless otherwise agreed, be treated as Confidential
Information.
54 ADDITIONAL PROVISION OF INFORMATION BY IMMUNOGEN
54.1 ImmunoGen agrees to provide BB with [*]
55 NON-SOLICITATION OF STAFF
55.1 For a period of [*] from the Effective Date, neither of the parties
shall do or permit any of the following without the prior written
consent of the other party:
55.1.1 solicit or entice away, or endeavor to solicit or entice away,
any key person employed by the other party in a managerial,
supervisory, technical, scientific or sales capacity.
55.1.2 cause or permit any Affiliate, and in the case of BB, any
Sub-licensee, to do any of the acts or things specified in
Clause 55.1.1.
55.2 Whilst the undertaking in Clause 55.1 is considered by the parties to
be reasonable in all the circumstances, if one or more is held invalid
as an unreasonable restraint of trade or for any other reason but would
have been held valid if part of the wording had been deleted, the
period reduced or the range of activities or area dealt with reduced in
scope, the undertakings shall apply with such modifications as may be
necessary to make them valid.
56 STANDSTILL PROVISIONS
56.1 For the duration of this Agreement and for a period of [*] from the
date on which this Agreement terminates for whatever reason neither
ImmunoGen nor BB will:
56.1.1 [*]
56.1.2 [*]
PART L - WARRANTY AND INDEMNITY PROVISIONS
57 REPRESENTATIONS AND WARRANTIES OF EACH PARTY
57.1 Each of ImmunoGen and BB hereby represents, warrants and covenants to
the other party that as at the Effective Date:
57.1.1 it is a corporation or entity duly organized and validly
existing under the laws of the state or other jurisdiction of
its incorporation or formation;
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57.1.2 the execution, delivery and performance of this Agreement by
such party has been duly authorized by all requisite corporate
action;
57.1.3 it has the power and authority to execute and deliver this
Agreement and to perform their obligations hereunder;
57.1.4 the execution, delivery and performance by such party of this
Agreement and its compliance with the terms and provisions
hereof does not and will not conflict with or result in a
breach of any of the terms and provisions of or constitute a
default under (i) a loan agreement, guaranty, financing
agreement, agreement affecting a product or other agreement or
instrument binding or affecting it, its Affiliates, or their
property; (ii) the provisions of its or its Affiliates'
charter or operative documents or bylaws; or (iii) any order,
writ, claim form, injunction or decree of any court or
governmental authority entered against it or its Affiliates or
by which any of its or their property is bound;
57.1.5 except for the governmental and Regulatory Approvals required
to market Product in the Territory, the execution, delivery
and performance of this Agreement by such party does not
require the consent, approval or authorization of, or notice,
declaration, filing or registration with, any governmental or
regulatory authority and the execution, delivery or
performance of this Agreement will not violate any law, rule
or regulation applicable to such party;
57.1.6 this Agreement has been duly authorized, executed and
delivered and constitutes such party's legal, valid and
binding obligation enforceable against it in accordance with
its terms subject, as to enforcement, to bankruptcy,
insolvency, reorganization and other laws of general
applicability relating to or affecting creditors' rights and
to the availability of particular remedies under general
equity principles;
57.1.7 there is no action, suit, notice of violation, proceeding or
investigation pending or, to the best of its knowledge,
threatened against it or any of its Affiliates or any of their
respective properties before or by any court, governmental or
administrative agency or regulatory authority which:
57.1.7.1 relates to or challenges the legality, validity or
enforceability of this Agreement; or
57.1.7.2 could, individually or in aggregate, materially
impair its ability to perform fully on a timely
basis its obligations under this Agreement.
Furthermore, the board of directors of each party does not
have knowledge of any fact or circumstance which is likely to
lead to any such action, suit, notice of violation, proceeding
or investigation; and
57.1.8 the information set out in the Schedules is true and accurate
in all material respects insofar as it is aware there is no
matter which renders any such information untrue, inaccurate,
incomplete or misleading.
57.2 Each of ImmunoGen and BB represents, warrants and covenants to the
other party that during the term of this Agreement it shall comply with
all applicable material laws and regulations relating to its activities
under this Agreement.
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58 REPRESENTATIONS AND WARRANTIES OF IMMUNOGEN
58.1 ImmunoGen represents, warrants and covenants to BB, except as set forth
in Schedule 10, in respect of the Territory and, where appropriate,
only to the extent that Licensed IP relates to the rights specifically
granted to BB in respect of the Licensed Compound or Product, that:
58.1.1 to the best of its knowledge, to the extent that they have
been granted, the Patents are valid, subsisting and
enforceable, in whole or in part, and there are no facts which
would as a matter of law preclude the issuance of Patents for
which patent applications are pending;
58.1.2 it has the full right, power and authority to grant all of the
right, title and interest in the licenses granted to BB under
Clause 2;
58.1.3 it and its Affiliates have not previously assigned,
transferred, conveyed or otherwise encumbered its right, title
and interest in the Licensed Compound, or the Licensed IP;
58.1.4 to the best of its knowledge, the Patents and the development,
manufacture, importation, exportation, keeping (whether for
disposal or otherwise) marketing, distribution, use,
promotion, offer for sale and sale of Licensed Compound or the
Product do not interfere or infringe on any intellectual
property rights owned or possessed by any Independent Third
Party;
58.1.5 to the best of ImmunoGen's knowledge, there are no claims,
judgements or settlements against or amounts with respect
thereto owed by ImmunoGen or pending or threatened claims or
litigation against ImmunoGen relating to Licensed Compound or
Licensed IP and no grounds exist which may support any such
claims;
58.1.6 it is in compliance in all material respects with any Third
Party Licenses relating to Licensed IP;
58.1.7 to the best of its knowledge, there are no circumstances that
would render BB liable to an Independent Third Party for
patent infringement as a consequence of BB's sale of Product
or use of the Licensed IP and there has been no claim
concerning such infringement made or considered by ImmunoGen;
58.1.8 to the best of its knowledge, all data summaries provided in
writing to BB by ImmunoGen relating to pre-clinical studies of
the Licensed Compound accurately represent the raw data
underlying such summaries;
58.1.9 to the best of ImmunoGen's knowledge, there is no fact
undisclosed by ImmunoGen which materially adversely affects or
would materially adversely affect the rights granted to BB
under this Agreement;
58.1.10 during the term of this Agreement, it and its Affiliates will
use reasonable commercial efforts not to diminish the rights
under the Licensed IP granted to BB hereunder, including
without limitation, by committing or permitting any actions or
omissions which would cause the breach of any agreements
between itself and Independent Third Parties which provide for
intellectual property rights applicable to the development,
manufacture,
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
use or sale of Licensed Compound and/or Product(s), and that
it will provide BB promptly with notice of any such breach.
58.2 Nothing in this Agreement or any license granted hereunder is to be
construed as a representation or warranty that Licensed Compound shall
be or is capable of being successfully developed or granted Regulatory
Approval in the Territory or any part thereof for the treatment of any
disease within the Field.
58.3 BB acknowledges that ImmunoGen has not given and BB is not relying on
any warranty, covenant or representation of any kind (other than
ImmunoGen's warranties, covenants and representations under Clauses 57
and 58.1) express or implied, in relation to Licensed Compound or its
use including but not limited to implied warranties for merchantability
or fitness for a particular purpose. BB further acknowledges that it
has made its own due and careful inquiries before entering this
Agreement.
59 [*]
59.1 [*]
60 NO INCONSISTENT AGREEMENTS
60.1 Neither party has in effect and after the Effective Date neither party
shall enter into any oral or written agreement or arrangement that
would be inconsistent with its obligations under this Agreement.
61 REPRESENTATION BY LEGAL COUNSEL
61.1 Each party hereto represents that it has been represented by legal
counsel in connection with this Agreement and acknowledges that it has
participated in the drafting hereof. In interpreting and applying the
terms and provisions of this Agreement, the parties agree that no
presumption shall exist or be implied against the party which drafted
such terms and provisions.
62 INDEMNIFICATION
62.1 BB shall indemnify and hold harmless ImmunoGen, its Affiliates and
their employees, officers, directors and agents (each, a "ImmunoGen
Indemnified Party") from and against any and all claims, demands,
lawsuits, proceedings, settlement amounts, liability, loss, damage,
cost and expense (including reasonable attorneys' fees), but subject to
the limitations in Clause 62.5 (collectively, a "Liability") which may
be asserted against the ImmunoGen Indemnified Party or which the
ImmunoGen Indemnified Party may incur, suffer or be required to pay
resulting from or arising out of (i) the research, discovery,
development, manufacture, importing, exporting, keeping (whether for
disposal or otherwise), promotion, distribution, use, testing,
marketing, sale of Licensed Compound and/or Product(s) by BB or
Sub-licensees (including without limitation any personal injury, death,
or other injuries suffered by users of Product), or (ii) the breach by
BB of any covenant, representation or warranty contained in this
Agreement; or (iii) the successful enforcement by a ImmunoGen
Indemnified Party of its rights under this Clause. Notwithstanding the
foregoing, BB shall have no obligation under this Agreement to
indemnify or hold harmless any ImmunoGen Indemnified Party with respect
to any Liability which results from the willful misconduct or negligent
acts or omissions of ImmunoGen, its Affiliates or any of their
employees, officers, directors or agents.
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62.2 ImmunoGen shall indemnify and hold harmless BB, its Affiliates and
their employees, officers, directors and agents (each, a "BB
Indemnified Party") from and against any Liability which the BB
Indemnified Party may incur, suffer or be required to pay resulting
from or arising out of (i) the development, manufacture, importing,
exporting, keeping (whether for disposal or otherwise), use or testing
of Licensed Compound and/or Product(s) by ImmunoGen (including without
limitation) any personal injury, death or other injuries suffered by
users of Product; (ii) the breach by ImmunoGen of any covenant,
representation or warranty contained in this Agreement; or (iii) the
successful enforcement by a BB Indemnified Party of its rights under
this Clause. Notwithstanding the foregoing, ImmunoGen shall have no
obligation under this Agreement to indemnify or hold harmless any BB
Indemnified Party with respect to any Liability which results from
willful misconduct or negligent acts or omissions of BB, its Affiliates
or their employees, officers, directors or agents.
62.3 Each party agrees to promptly give the other party notice of any claim
for which indemnification may be sought. Failure of an indemnified
party to provide notice of a claim to the indemnifying party shall
affect the indemnified party's right to indemnification only to the
extent that such failure has a material adverse effect on the
indemnifying party's ability to defend or the nature or the amount of
the Liability. Subject to the provisions of Section G (Patent
Provisions) of this Agreement, the indemnifying party shall have the
right to assume the defense of any suit or claim related to the
Liability if it has assumed responsibility for the suit or claim in
writing; provided, however, that if in the reasonable judgement of the
indemnified party, such suit or claim involves an issue or matter which
could have a materially adverse effect on the business operations or
assets of the indemnified party, the indemnified party may waive its
rights to indemnity under this Agreement and control the defense or
settlement thereof, but in no event shall any such waiver be construed
as a waiver of any indemnification rights such party may have at law or
in equity. If the indemnifying party defends the suit or claim, the
indemnified party may participate in (but not control) the defense
thereof at its sole cost and expense.
62.4 Subject to the provisions of Part G (Patent Provisions) of this
Agreement, neither party may settle a claim or action related to a
Liability without the consent of the other party if such settlement
would impose any monetary obligation on the other party or require the
other party to submit to an injunction or otherwise limit the other
party's rights under this Agreement, provided that such consent shall
not be unreasonably withheld or delayed. Any payment made by a party to
settle any such claim or action shall be at its own cost and expense.
62.5 With respect to any claim by one party against the other arising out of
the performance or failure of performance of the other party under this
Agreement, the parties expressly agree that the liability of such party
to the other party for such breach shall be limited under this
Agreement or otherwise at law or equity to direct damages only and in
no event shall a party be liable for, punitive, exemplary or
consequential damages suffered or incurred by the other party.
62.6 Each party acknowledges and agrees that during the term of this
Agreement it shall maintain adequate insurance for contractual
liability insurance to cover such party's obligations under this
Agreement (including product liability). The Collaboration Committee
shall review the level of each party's insurance coverage annually to
ensure that it is, in their reasonable opinion, adequate, taking into
account all relevant circumstances. Each party shall provide the other
party with evidence of such insurance upon request.
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PART M - GENERAL PROVISIONS
63 BANKRUPTCY PROTECTION
63.1 RETENTION OF LICENSE RIGHTS. All licenses and rights granted under or
pursuant to this Agreement by ImmunoGen to BB are, and shall otherwise
be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy
Code, licenses of rights to "intellectual property" as defined under
Section 101(52) of the U.S. Bankruptcy Code. The parties agree that BB,
as a licensee of such rights under this Agreement, shall retain and may
fully exercise all of its rights and elections under the U.S.
Bankruptcy Code, subject to performance by BB of its pre-existing
obligations under this Agreement. The parties further agree that, in
the event of the commencement of a bankruptcy proceeding by or against
ImmunoGen under the U.S. Bankruptcy Code, BB shall be entitled to a
complete duplicate of (or complete access to, as appropriate) any such
intellectual property and all embodiments of such intellectual
property, and same, if not already in its possession, shall be promptly
delivered to BB (a) upon any such commencement of a bankruptcy
proceeding upon written request therefor by BB, unless ImmunoGen elects
to continue to perform all of its obligations under this Agreement, or
(b) if not delivered under (a) above, upon the rejection of this
Agreement by or on behalf of ImmunoGen upon written request therefor by
BB, provided, however, that upon ImmunoGen's (or its successor's)
written notification to BB that it is again willing and able to perform
all of its obligations under this Agreement, BB shall promptly return
all such tangible materials to ImmunoGen, but only to the extent that
BB does not require continued access to such materials to enable BB to
perform its obligations under this Agreement.
64 NOTICES
64.1 ADDRESS DETAILS. Any notice required or permitted under this Agreement
shall be delivered by hand or sent by courier, by first class postage
prepaid and receipt requested or by facsimile transmission to the
following addresses of the parties:
BB's Address: British Biotech Pharmaceuticals Limited
Xxxxxxxxxx Xxxx
Xxxxxx XX0 0XX
Xxxxxxx
Fax no: x00-0000-000000
For the attention of the Legal Department
ImmunoGen's Address: ImmunoGen Inc.
000 Xxxxxxxxxx Xxxxxxx
Xxxxxxx, XX 00000
XXX
Fax no: (000) 000-0000
For the attention of Chief Executive Officer
With copies to: Xxxxx. Xxxxx, Cohn, Ferris, Glovsky
and Popeo, P.C.
Xxx Xxxxxxxxx Xxxxxx
Xxxxxx, XX 00000
Attn: Xxxxxxx X. Xxxxxx, Esq.
Fax no.: (000) 000-0000
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64.2 TIME OF RECEIPT. Any notice required or permitted to be given
concerning this Agreement shall be deemed to have been received by the
party to whom it is addressed:
64.2.1 if delivered by hand, upon receipt at the premises referred to
above; or
64.2.2 if sent by post or by courier, on the date it was received as
recorded on the return receipt; or
64.2.3 if sent by facsimile (confirmed by letter sent by first class
post), at the time of receipt shown on the transmission
confirmation report.
64.3 LANGUAGE OF NOTICE. Any notice or other document served by one party on
the other in accordance with the terms of this Agreement shall be in
the English language and shall not be validly served unless this
condition is complied with.
65 FORCE MAJEURE
65.1 Failure of any party to perform its obligations under this Agreement
(except the obligation to make payments when properly due) shall not
subject such party to any liability or place them in breach of any term
or condition of this Agreement to the other party if such failure is
due to any cause beyond the reasonable control of such non-performing
party ("force majeure"), unless conclusive evidence to the contrary is
provided. Causes of non-performance constituting force majeure shall
include, without limitation, acts of God, fire, explosion, flood,
drought, war, riot, sabotage, embargo, strikes or other labor trouble,
failure in whole or in part of suppliers to deliver on schedule
materials, equipment or machinery, interruption of or delay in
transportation, a national health emergency or compliance with any
order or regulation of any government entity acting with color of
right. The party affected shall promptly notify the other party of the
condition constituting force majeure as defined herein and shall exert
reasonable efforts to eliminate, cure and overcome any such causes and
to resume performance of its obligations with all possible speed;
provided, however, that nothing contained herein shall require any
party to settle on terms unsatisfactory to such party any strike,
lock-out or other labor difficulty, any investigation or proceeding by
any public authority, or any litigation by any third party. If a
condition constituting force majeure as defined herein exists for more
than ninety (90) consecutive days, the parties shall meet to negotiate
a mutually satisfactory resolution to the problem, if practicable.
66 ASSIGNMENTS
66.1 Neither this Agreement nor any or all of the rights and obligations of
a party hereunder shall be assigned, delegated, sold, transferred,
sublicensed (except as expressly permitted hereunder) or otherwise
disposed of, by operation of law or otherwise, to any Independent Third
Party (other than an Affiliate of an assigning party under the
condition that the assignor remain responsible to the other party under
this Agreement), without the prior written consent of the other party.
Any attempted assignment, delegation, sale, transfer, sublicense or
other disposition, by operation of law or otherwise, of this Agreement
or of any rights or obligations hereunder contrary to this Clause 66.1
shall be a material breach of this Agreement by the attempting party,
and shall be void and without force or effect; provided, however,
either party may, without such consent, assign the Agreement and its
rights and obligations hereunder to an Affiliate or in connection with
the transfer or sale of all or substantially all of its assets related
to the division or the subject business, or in the event of its merger
or consolidation or change in control or similar transaction.
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66.2 This Agreement shall be binding upon, and inure to the benefit of, each
party and its permitted successors and assigns. Each party shall be
responsible for the compliance by its Affiliates with the terms and
conditions of this Agreement.
67 SEVERABILITY
67.1 In the event that any Clause or any part of any Clause contained in
this Agreement is declared invalid or unenforceable by the judgment or
decree by consent or otherwise of a Court of competent jurisdiction not
subject to appeal, all other Clauses or parts of Clauses contained in
this Agreement shall remain in full force and effect and shall not be
affected thereby for the term of this Agreement.
68 WAIVER
68.1 No relaxation, forbearance, delay or indulgence by either party in
enforcing any of the terms and conditions of this Agreement or the
granting of time by either party to the other shall prejudice, affect
or restrict the rights and powers of that said party hereunder nor
shall any waiver by either party of any breach hereof operate as a
waiver of or in relation to any subsequent or any continuing breach
hereof.
68.2 A waiver by one party of a breach by the other of any term of this
Agreement shall not prevent the subsequent enforcement of that term and
shall not be deemed a waiver of any subsequent breach.
69 VAT
69.1 Any amount payable under this Agreement shall be deemed to be exclusive
of Value Added Tax.
70 COSTS OF PREPARATION
70.1 The parties hereto shall pay their own respective legal costs incurred
in the preparation of this Agreement.
71 GOVERNMENT CONSENT
71.1 Insofar as this Agreement requires the consent of any official body of
the Government of either the UK or the USA, each party shall use its
reasonable endeavors to obtain the approval of such body in such
country and notify the other thereof promptly.
72 INDEPENDENT DISCOVERIES BY BB
72.1 Subject to the provisions of this Agreement, ImmunoGen acknowledges
that BB has ongoing research programs which may now or in the future
independently discover, develop and/or acquire technologies and/or
products relating to treatment and prevention of any disease, disorder
or condition in humans or animals. ImmunoGen agrees that such
technologies and products, to the extent discovered without use of
Patents or Technical Information, will not be deemed to be BB Technical
Information or Improvements and will fall outside the scope of this
Agreement.
54
55
CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
73 INDEPENDENT RELATIONSHIP
73.1 Nothing in this Agreement shall be deemed to create an employment,
agency, joint venture or partnership relationship between the parties
hereto or any of their respective agents or employees, or any other
legal arrangement that would impose liability upon one party for the
act or failure to act of the other party. Neither party shall have any
power to enter into any contracts or commitments or to incur any
liabilities in the name of, or on behalf of, the other party, or to
bind the other party in any respect whatsoever. Further, nothing in
this Agreement shall entitle either party to make any representation or
give a warranty on behalf of the other party.
74 COUNTERPARTS
74.1 This Agreement shall become binding when any one or more counterparts
hereof, individually or taken together, shall bear the signatures of
each of the parties hereto. This Agreement may be executed in any
number of counterparts, each of which shall be an original as against
either party whose signature appears thereon, but all of which taken
together shall constitute but one and the same instrument.
75 RECORDING
75.1 Each party shall have the right, at any time, to record register, or
otherwise notify this Agreement in appropriate governmental or
regulatory offices anywhere in the world, and each party shall provide
reasonable assistance to the other in effecting such recording,
registering or notifying. Notwithstanding the foregoing, prior to
recording, registering, or otherwise notifying this Agreement, the
party desiring to so record, register, or notify shall provide a copy
of all materials to be filed for review, comment and approval by the
other party, such approval not unreasonably to be withheld or delayed.
76 FURTHER ACTIONS
76.1 Each party agrees to execute, acknowledge and deliver such further
instruments, and to do all other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this
Agreement including, without limitation, any filings with any antitrust
agency which may be required.
77 ENTIRE AGREEMENT
77.1 This Agreement (including its Exhibits and Schedules) [*] set forth the
entire agreement and understanding of the parties relating to the
subject matter hereof, and merge all prior discussions between them and
all prior memoranda of intent or understanding. Neither party shall be
bound by any definition, condition or representation other than as
expressly stated in this Agreement or as subsequently agreed by the
parties in writing, signed by a duly authorized officer of each party.
55
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SCHEDULE 1
PART 1 - CHEMICAL STRUCTURE OF huN901
AMINO ACID SEQUENCES OF CDR-GRAFTED V(L) AND V(H) OF huN901. Numbering follows
the Xxxxx system. The constant regions are human (kappa) for the light chain and
human (gamma)-1 for the heavy chain.
V(L)
----.---10----.---20--- -.--ABCDEF-30---- .---40----.----50----.- --60----.
DVVMTQSPLSLPVTLGQPASISC RSSQIIIHSDGNTY-LE WFQQRPGQSPRRLIY KVSNRFS GVPDRFSGS
----------------- -------
CDR L1 CDR L2
---70----.---80----.--- 90----.-- 100----.--
GSGTDFTLKISRVEAEDVGVYYC FQGSHVPHT FGQGTKVEIK
---------
CDR L3
V(H)
----.---10----.---20----.---30 ----. ---40----.----50--A--.--- 60--- -- .
QVQLVESGGGVVQPGRSLRLSCAASGFTFS SFGMH WVRQAPGKGLEWVA YISSGSFTIY YADSVKG
----- ----------
CDR H1 CDR H2
---70----.---80--ABC--. -- --90---- . -- -100A-- --. -- -110--
RFTISRDNSKNTLYLQMNSLRAEDTAVYYCAR MRKGYAMDY WGQGTLVTVS
---------
CDR H3
CDR = Complementarity-Determining Regions
V(L) = variable region, light chain
V(H) = variable region, heavy chain
56
57
SCHEDULE 1
PART 2 - CHEMICAL STRUCTURE OF LICENSED COMPOUND, huN901-DM1
[2 GRAPHICS OMITTED EACH DEPICTING THE MOLECULAR
STRUCTURE OF THE LICENSED COMPOUND, huN9901-DM1]
57
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SCHEDULE 2
PATENTS
MAYTANSINOID CONJUGATES
-----------------------------------------------------------------------------------------------------------------------------------
Attorney Country Appl. No. Filing Date Priority Patent No. Issue Date Exp. Date Next Annuity
Reference No. Date Date
-----------------------------------------------------------------------------------------------------------------------------------
A-5567 U.S. 07/426,247 10/25/89 Abandoned
A-5567-1 U.S.
Rule 62 07/911,380 07/13/92 10/25/89 5,208,020 05/04/93 05/04/10 11/04/00
Continuation
F89903 Europe* 0 90 311 590.5 10/23/90 10/25/89 0 425 235 B1 09/25/96 10/23/10 10/23/00
*National
Patents in AT,
BE, CH, DE,
DK, ES, FR,
XX, XX, XX,
XX, XX, SE
DE number: G
690 28678.3-08
F89902 Canada 2,026,147-1 09/25/90 10/25/89 Pending 9/25/00
F89904 Japan 2-290,625 10/25/90 10/25/89 Pending
-----------------------------------------------------------------------------------------------------------------------------------
N901 ANTIBODY
-----------------------------------------------------------------------------------------------------------------------------------
Attorney Country Appl. No. Filing Date Priority Patent No. Issue Date Exp. Date Next Annuity
Reference No. Date Date
-----------------------------------------------------------------------------------------------------------------------------------
XXXX #00
00000/000 X.X. 06/603,181 04/23/84 4,772,552 09/20/88 09/20/05 03/17/00
00530/028EP1 Europe* 0 85 302 806.6 04/22/85 04/23/84 160486 01/02/92 04/22/05 04/22/00
*National
Patents in AT,
BE, CH, DE,
FR, XX, XX,
XX, XX, XX,
SE
00530/028CA1 Canada 479685 04/22/85 04/23/84 1271715 07/17/90 04/22/05 07/17/00
00000/000XX0 Xxxxx 87354/85 04/23/85 04/23/84 1875957 10/07/94 04/23/05 12/21/00
00000/000XX0 Xxxxx
(Divisional) 323131/92 04/23/85 04/23/84 1999925 12/08/95 04/23/05 04/19/00
-----------------------------------------------------------------------------------------------------------------------------------
N901 SYNERGY
-----------------------------------------------------------------------------------------------------------------------------------
Attorney Country Appl. No. Filing Date Priority Patent No. Issue Date Exp. Date Next Annuity
Reference No. Date Date
-----------------------------------------------------------------------------------------------------------------------------------
104322.198 U.S.
(Provisional) 60/157,051 10/01/99 Pending
-----------------------------------------------------------------------------------------------------------------------------------
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
SCHEDULE 3
DEVELOPMENT PLAN
REGULATORY AND CLINICAL STRATEGY FOR huN901-DM1
[*]:
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SCHEDULE 4
PRINCIPAL TERMS OF COMMERCIAL SUPPLY AGREEMENT
1 PARTIES
1.1 The Agreement shall be between British Biotech Pharmaceuticals Limited
and ImmunoGen Inc.
2 MANUFACTURE AND SUPPLY
2.1 British Biotech will appoint ImmunoGen to manufacture and supply, and
ImmunoGen will manufacture and supply to British Biotech, Product for
commercial use in the Territory.
3 WARRANTIES AND COVENANTS
3.1 ImmunoGen will warrant, amongst other things, that:
- all Product manufactured will comply with the manufacturer's
licenses, the Regulatory Approvals, the Specifications and all
applicable laws and regulations in force from time to time in
the relevant part of the Territory in respect of which Product
will be sold in;
- it will promptly disclose to British Biotech any comments by
Regulatory Authorities concerning its manufacturer's licenses
and that it will not seek to vary its manufacturer's licenses
without the consent of British Biotech (not to be unreasonably
withheld);
- all Product supplied will have a minimum shelf life, to be
agreed by the parties;
- all Product will be batch marked in accordance with agreed
marking procedures;
- all raw materials and Product will be stored in accordance
with the terms of the manufacturer's licenses and the
Regulatory Approvals pending delivery to British Biotech.
3.2 ImmunoGen will covenant, amongst other things, that:
- it will have and will maintain all necessary manufacturer's
licences in accordance with all applicable laws and
regulations to manufacture and supply Product for use in the
Territory;
- it will conduct the manufacture in accordance with the
Technical Agreement to be agreed by the parties;
- any raw materials employed by ImmunoGen in the Manufacture
will comply with the Specifications;
- it will allow, during normal business hours and upon
reasonable notice, authorised representatives of British
Biotech and representatives of any Government or regulatory
bodies to inspect the premises where the manufacture of the
Product is carried out or the Product or raw materials are
stored and to inspect the process of manufacture;
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
- it will upon written request supply BB with reasonable
quantities of samples of the Product manufactured by it;
- it shall retain a quantity of samples of each production batch
of the Products equal to twice the amount reasonably required
to conduct relevant analysis;
- it shall retain all manufacturing, analytical and distribution
records and shall retain such samples of the Products as are
required by, and in the manner and for the duration specified
by, all applicable laws and regulations, including GMP. Such
records will be made available to BB upon reasonable notice.
Records and samples shall not be destroyed without notice to
BB;
- it will have in place and will continue to have in place, and
will procure that any approved sub-contractors have in place,
appropriate health and safety procedures in compliance with
all applicable laws in the Territory.
3.3 BB will covenant that it will have and will maintain throughout the
term of this Agreement appropriate Regulatory Approvals for the Product
in the Territory or part(s) thereof for which the Product is to be
marketed distributed sold or used.
4 TECHNICAL AGREEMENT
4.1 The respective responsibilities of ImmunoGen and BB relating to the
manufacture of Product shall be as specified in the Technical Agreement
to be agreed by the parties which agreement shall include, amongst
other things, terms relating to:
- the way in which each batch of Product is to be manufactured
and checked for compliance with and adherence to the
appropriate Specifications and GMP
- the responsibility for purchasing materials
- testing and releasing materials
- undertaking production and quality control including
in-process controls as well as sampling and analysis
5 DURATION
5.1 The Agreement shall continue until the expiry or termination of the
Collaboration, Development and License Agreement subject to the
specific exceptions contained therein. Further, at least [*] prior to
the expiry of the Collaboration, Development and License Agreement, the
parties shall meet to discuss terms for the continued supply of Product
to British Biotech.
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
6 FORECASTS
6.1 The parties shall agree upon appropriate provisions regarding the
submission by British Biotech of non-binding and binding estimates for
Product. Procedures relating to the provision by ImmunoGen of the
confirmation of orders shall be agreed, which confirmations shall
specify, amongst other things, quantity to be supplied and delivery
times.
6.2 The parties shall agree upon a suitable amount of Product in respect of
which British Biotech shall be entitled to order on a binding basis in
addition to amount estimated (for example, up to fifty per cent. (50%)
more than the quantity specified in the non-binding forecast for such
month).
6.3 In addition to the above, if so requested, ImmunoGen will use
reasonable efforts but with no obligation in respect of the quantity
thereof, to supply to British Biotech additional Product in excess of
that ordered or contained in the relevant forecast having due regard
for ImmunoGen production capacity and other manufacturing commitments.
7 SUPPLY
7.1 Product shall be supplied by ImmunoGen in final form, fully packaged
and ready for sale and shall be delivered to British Biotech or its
designee [*]. In addition, ImmunoGen shall supply British Biotech with
those documents specified in the Technical Agreement with each batch of
the Product.
7.2 [*] Notwithstanding [*], title to the Product shall be and remain with
ImmunoGen unless and until BB has paid in full for such Product.
7.3 Procedures relating to inspection and/or testing of Product by British
Biotech following delivery shall be agreed, which procedures shall also
regulate the rejection and/or acceptance of Product by British Biotech
together with a dispute resolution procedure in the event of
disagreement. Product inspection and testing shall be to ensure
compliance with the Specifications.
7.4 If ImmunoGen accepts that the Product does not conform to the
Specifications due to the negligence or default of ImmunoGen then
ImmunoGen shall manufacture and deliver to BB (at no additional cost to
British Biotech) a sufficient quantity of the Product to replace the
defective batch or batches. If BB accepts that the relevant batches of
Product were Manufactured in accordance with the Specifications or that
any defect did not arise due to ImmunoGen negligence or default
ImmunoGen shall have no liability or obligation to BB in respect of
such Batches.
7.5 To the extent that [*]
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
8 INTELLECTUAL PROPERTY
8.1 Save as specifically provided, neither party shall acquire any rights
in respect of any of the other party's intellectual property in
relation to the Products or the manufacture thereof or of the goodwill
associated therewith.
9 PRICES
9.1 The Agreement shall state a price to be charged for the Product, which
price shall be effective for a stated period (for example twelve (12)
months) subject only to variations due to direct increases or savings
(for example raw material costs, economies of scale etc.) during such
period.
9.2 A mechanism for the review of price of Product shall be agreed which
shall regulate annual price increases/decreases following the initial
period.
In addition, ImmunoGen may review the price to take account of any
increased cost of production and raw material costs provided that such
review [*]
9.3 Invoices will be submitted to BB when the Product has been delivered.
BB will pay such within [*] after the date of receipt of the invoice
unless there is any dispute relating to the conformity of the Product
with the Specifications, in which case payment will be made within [*]
of receipt by British Biotech of conforming Product or agreement that
the original Product was conforming.
9.4 If, as a result of any inspection of the manufacturing premises used by
ImmunoGen, a requirement is imposed by a competent authority which
leads to or requires a change in the cost of production or to the
Specification of the Product then, upon written notification by
ImmunoGen to BB, ImmunoGen and BB will meet to discuss any increase to
the price of the Product, the date upon which such price increase will
take effect and any other consequences arising from such changes.
Failure to reach agreement within an agreed time, shall mean the matter
being subject to the agreed dispute resolution provisions.
9.5 ImmunoGen shall agree that [*]
10 INDEMNITY
10.1 Each party (the "indemnifying party") shall indemnify other party (the
"indemnified party") against legal liability to third parties in
respect of all claims, actions, judgements, damages, lawsuits, costs or
expenses or professional fees incurred or arising out of (a) any breach
of contract by or any act or omission of the indemnifying party, its
employees, sub-contractors or agents; (b) any claim for death or
personal injury incurred by the indemnified party in relation to or
arising out of any breach of contract by the indemnifying party or any
negligent act or omission of the indemnifying party, its employees,
sub-contractors or agents.
10.2 A notification procedure shall be agreed to regulate how an indemnified
party may claim the benefit of any indemnity, to include notification
of any claims, and agreement not to compromise the conduct of any such
claims or take any material steps in relation to such claims without
the prior consent of the indemnifying party and co-operation with the
indemnifying party in the handling of any such claims.
11 CONTRACT MANUFACTURE AND ALTERNATE SUPPLY
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11.1 ImmunoGen shall be entitled to appoint sub-contractors to perform its
obligations under the Supply provided that it complies with the
provisions of Clause 25 of the License Agreement and provided that
British Biotech is entitled to audit such proposed sub-contractor prior
to appointment and, to the extent that any such proposed third party
fails such audit, to require all corrective steps to be taken by such
third party, to British Biotech's reasonable satisfaction, prior to
appointment.
11.2 To the extent that sub-contractors are appointed by ImmunoGen, it shall
ensure that an appropriate technical agreement is put in place
11.3 ImmunoGen shall use commercially reasonable efforts to cause at least
two sources of supply to become and remain pre-qualified during the
continuance of the Agreement.
12 INABILITY TO SUPPLY
12.1 The Agreement shall incorporate provisions equivalent to those set out
in Clause 27 of the License Agreement, enabling British Biotech to
assume responsibility for manufacture of Product in the event that
ImmunoGen is unable for whatever reason to deliver British Biotech's
Product requirements. In such event, ImmunoGen shall co-operate with
British Biotech, in terms of transfer of information and provision of
assistance, to enable British Biotech to assume manufacturing
responsibility.
13 STOCK REPORTING
13.1 The parties shall agree upon the timetable for ImmunoGen to report to
British Biotech on stock held and work-in-progress, the form of which
report shall be agreed upon by the parties.
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WITH THE SECURITIES AND EXCHANGE COMMISSION
SCHEDULE 5
LIST OF THIRD PARTY LICENSES
[*]
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WITH THE SECURITIES AND EXCHANGE COMMISSION
SCHEDULE 6
REGISTRATION IN THE REST OF THE WORLD,
BASED ON AN EU/USA DEVELOPMENT PLAN
[*]
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CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
SCHEDULE 7
CMC DEVELOPMENT ACTIVITIES FOR huN901-DM1
1. MANUFACTURING PROCESS
Develop the manufacturing process to:
[*]
2. PRODUCT DEVELOPMENT
[*]
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CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
3. ANALYTICAL METHODS
[*]
4. STABILITY STUDIES
[*]
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
5. COMPATIBILITY TESTING
[*]
6. CLINICAL TRIAL SUPPLIES (CTS)
[*]
7. DOCUMENTATION
[*]
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
SCHEDULE 8
COGS CALCULATION
[*]
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CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS INDICATED BY "*", HAVE BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION
SCHEDULE 9
SCHEDULE OF COSTS FOR BIOANALYTICAL WORK
TO BE CONDUCTED BY IMMUNOGEN UNDER CLAUSE 14.2
[*]
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SCHEDULE 10
FURTHER THIRD PARTY LICENSES
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IN WITNESS whereof each of the parties intend this Agreement to be a deed and
have caused it to be executed as such by executed by their duly authorized
representatives the day and year first before written.
------------------------------------------
Signed and delivered as a deed on behalf of
BRITISH BIOTECH PHARMACEUTICALS LIMITED
by:
Name:
Title:
------------------------------------------
Signed and delivered as a deed on behalf of
IMMUNOGEN, INC
by:
Name:
Title:
73
