Document:

Exhibit
10.1

 

DEVELOPMENT AND LICENSE
AGREEMENT

 

This Development and
License Agreement (this “Agreement”) is made effective as of October 1, 2004
(the “Effective Date”) by and between Biogen Idec MA Inc., a Massachusetts
corporation with its principal place of business at 14 Cambridge Center,
Cambridge, Massachusetts 02142 (“Biogen Idec”), and ImmunoGen, Inc., a
Massachusetts corporation with its principal place of business at 128 Sidney
Street, Cambridge, Massachusetts 02139 (“ImmunoGen”).  Biogen Idec and ImmunoGen are sometimes each
hereinafter referred to individually as a “Party” and collectively as the “Parties”.

 

WHEREAS, Biogen Idec is
the owner of or otherwise controls certain rights in proprietary technology and
know-how relating to certain [***]
Antibodies (as defined below); and

 

WHEREAS, ImmunoGen is the
owner of or otherwise controls certain rights in proprietary technology and
know-how relating to or otherwise useful in the conjugation of maytansine
derivatives to binding proteins; and

 

WHEREAS, pursuant to the
terms and conditions set forth herein, Biogen Idec desires to obtain from
ImmunoGen, and ImmunoGen desires to grant to Biogen Idec, a license under
certain of ImmunoGen’s technology and/or intellectual property rights to
develop and commercialize one or more Licensed Products (as defined below).

 

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

 

1.                                      DEFINITIONS

 

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

 

1.1.                            “Adverse Drug Experience” is defined in
21 CFR 310.305, 21 CFR 314.80, and 21 CFR 600.80, as amended, or any
replacements thereof.

 

 

CONFIDENTIAL

Portions of this Exhibit
were omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Act of 1934.

 

1

 

1.2.                            “Affiliate” shall mean any
corporation, firm, limited liability company, partnership or other entity which
directly or indirectly controls or is controlled by or is under common control
with a Party to this Agreement.  For purposes of this Section 1.2, “control”
means ownership, directly or indirectly through one or more Affiliates, of
fifty percent (50%) or more of the shares of stock entitled to vote for the
election of directors, in the case of a corporation, or fifty percent (50%) or
more of the equity interests in the case of any other type of legal entity, or
status as a general partner in the case of any partnership, or any other
arrangement whereby a Party controls or has the right to control the Board of
Directors or equivalent governing body or management of a corporation or other
entity.

 

1.3.                            “Agreement” shall mean this
Development and License Agreement between the Parties, dated as of the
Effective Date, including any
exhibits, schedules or other attachments hereto and incorporated herein, as any
of the foregoing may be validly amended from time to time.  In the event of any inconsistency between the
terms of this Agreement and the terms of any exhibits, schedules or other
attachments incorporated herein, unless the Parties expressly agree otherwise
in writing, the terms of this
Agreement shall govern.

 

1.4.                            “Antibody” shall mean a composition
comprising a whole antibody or fragment thereof (whether polyclonal or
monoclonal, multiple or single chain, recombinant, transgenic animal derived or
naturally occurring, and any
constructs thereof) or having been derived from nucleotide sequences encoding,
or amino acid sequences of, such an antibody or fragment.

 

1.5.                            “[******************]” shall mean
any Program Technology that is a structural modification, formulation, method
of use, administration or delivery of an [***]
[***] or other [***] not [***]
to a [***]  [***********].

 

1.6.                            “[***] Antibody”
shall mean any Antibody that is Controlled by Biogen Idec and that binds with a
protein encoded by any gene within the [***]
Gene Family.

 

1.7.                            “Biogen Idec Background Technology”
means any Technology used by Biogen Idec,
or provided by Biogen Idec for use, in the Research Program that is useful in
the Field and that is (a) Controlled by Biogen Idec as of the Effective Date or
(b) Controlled by Biogen Idec and developed or conceived by employees of, or
consultants to, Biogen Idec on and after the Effective Date in the conduct of
activities outside the Research Program and without the use of any Licensed
Technology, Licensed Patent Rights or Joint Program Technology.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

2

 

1.8.                            “Biogen Idec Patent Rights” shall mean
all Patent Rights with respect to Biogen Idec Background Technology.

 

1.9.                            “Biogen Idec Program Technology”
shall mean any Program Technology made solely by employees of, or agents or
others obligated to assign inventions to, Biogen Idec or a Biogen Idec
Affiliate.

 

1.10.                     “BLA” shall mean a
biologics license application (as defined in Title 21 of the United States Code
of Federal Regulations, as amended from time to time) filed with the FDA
seeking Regulatory Approval to market and sell any Licensed Product in the
United States for a particular indication within the Field.

 

1.11.                     “Clinical Materials” shall mean any MAY Compound and/or [*****]-MAY
Conjugates supplied by ImmunoGen to Biogen Idec pursuant to Section 4.3
and/or the Supply Agreement for use in human clinical testing.

 

1.12.                     “Collaboration Committee”
shall mean the committee with representatives of each Party established as set
forth in Section 3.4.

 

1.13.                     “Combination Product” shall mean a
product containing both a Licensed Product and one or more other active
ingredients in addition to the Licensed Product that are not covered by the
Licensed Patent Rights or do not incorporate Licensed Technology where the
other active ingredients have independent, additive or synergistic diagnostic,
prophylactic or therapeutic effect in the disease or indication for which the
Combination Product is labeled, whether the Licensed Product and the other
active ingredients are together in a physical mixture or packaged and priced
together as a single product.

 

1.14.                     “Commercialization” or “Commercialize” shall mean any and all
activities constituting importing, marketing, distributing, offering for sale,
selling, making, having made, exporting, having exported and supporting the
Licensed Product in the Territory for use in the Field.  Commercialization shall include, but not be
limited to, promotion as well as post-approval clinical trial and regulatory
activities, including Adverse Drug Experience reporting.  When used as a verb, Commercialize shall mean
to engage in Commercialization.

 

1.15.                     “Confidential Information” shall mean,
with respect to a Party (the “receiving Party”), all information which is
disclosed by the other Party (the “disclosing Party”) to the receiving Party
hereunder or to any of its employees, consultants, Affiliates or Sublicensees,

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

3

 

except to the extent that the receiving Party can demonstrate by
written record or other suitable physical evidence that such information,
(a) prior to the disclosure is demonstrably known to the receiving Party
or its Affiliates other than by virtue of a prior confidential disclosure to
such Party or its Affiliates; (b) as of the date of disclosure is in, or
subsequently enters, the public domain, through no fault or omission of the
receiving Party; (c) is obtained from a Third Party having a lawful right
to make such disclosure free from any obligation of confidentiality to the
disclosing Party; or (d) is independently developed by or for the
receiving Party without reference to or reliance upon any Confidential
Information of the Disclosing Party.  For
purposes of clarity, subject to the exceptions in the preceding sentence or as
otherwise set forth in this Agreement, (a) any technical or financial
information of a disclosing Party disclosed at any meeting of the Collaboration
Committee, or disclosed through an audit or other report shall constitute
Confidential Information of such disclosing Party, (b) the terms of this
Agreement, to the extent not disclosed in a public filing or press release
permitted under Section 6 of this Agreement, shall constitute Confidential
Information of each Party unless otherwise specified, (c) all know-how and
trade secrets disclosed by ImmunoGen to Biogen Idec in connection with the licenses
set forth in Section 2.1 of this Agreement shall constitute Confidential
Information of ImmunoGen, and (d) all know-how and trade secrets disclosed by
Biogen Idec to ImmunoGen in connection with the license set forth in
Section 2 of this Agreement shall constitute Confidential Information of
Biogen Idec.

 

1.16.                     “Consumer Price Index or CPI” shall mean
the CPI for All Urban Consumers published from time to time by the Bureau of
Labor Statistics of the United States Department of Labor.

 

1.17.                     “Contract Year” shall mean the period
beginning on the Effective Date and ending on December 31, 2004 and each
succeeding calendar year thereafter during the Term.

 

1.18.                     “Control” or “Controlled”
shall mean, with respect to any Patent Rights Technology or Proprietary
Materials (including, without limitation, any MAY Compound, [***] Antibody or other proprietary
biologic material covered under this Agreement), the possession by a Party of
the ability to grant a license or sublicense (other than by rights granted in
this Agreement) of such Patent Rights or Technology and the rights thereto or
to supply such

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application requesting
confidential investment under Rule 24b-2 under the Securities Exchange Act of
1934.

 

4

 

Proprietary Materials as provided for in this Agreement without
violating the terms of any arrangement or agreement between such Party or its
Affiliates and any Third Party.

 

1.19.                     “Cost” shall mean, with
respect to any Preclinical Materials or Clinical Materials manufactured and QC
tested by ImmunoGen, ImmunoGen’s fully-burdened costs (including the costs
associated with product testing and release activities) of producing and
packaging such Preclinical or Clinical Materials, including the sum of the
following components:  (a) direct costs,
including (1) materials directly used in producing and packaging such Preclinical
Materials or Clinical Materials and (2) with respect to any Preclinical
Materials or Clinical Materials obtained by ImmunoGen from a Third Party and
supplied to Biogen Idec without modification, the amount paid by ImmunoGen to
such Third Party for the same; (b) an allocation of manufacturing overhead
costs, including manufacturing and quality labor and manufacturing and quality
supervisory services, operating and administrative costs of the manufacturing
and quality departments and occupancy costs which are allocable to company
departments based on space occupied or headcount, or another activity-based
method; (c) any other reasonable out-of-pocket costs borne by ImmunoGen for the
testing, transport, customs clearance, duty, insurance and/or storage of such
Preclinical Materials or Clinical Materials; and (d) ImmunoGen’s general and
administrative costs, including purchasing, human resources, payroll,
information system and accounting, which are allocable to its departments based
on space occupied or headcount or another activity-based method, according to
GAAP.  Manufacturing overhead costs under
the foregoing clause (b) and administrative costs under the foregoing clause
(d) are allocable to each batch of Preclinical Material and/or Clinical
Material produced based upon the [***]
of [***], or any portion of a [***], that a manufacturing [***] is [***]
to the [***] (including [******] and [********]) of [***]-MAY
Conjugate at ImmunoGen’s facilities. 
Notwithstanding the foregoing, Cost shall not include the cost of
purchasing any Dedicated Equipment pursuant to Section 4.4 of this
Agreement.

 

1.20.                     “[***] Gene Family” shall mean the
family of human [***] genes that
encode the proteins known as, [*****]
or [**************************] ([***]) [***],
the polypeptide sequences which are set forth on Schedule C attached
hereto, any polynucleotide encoding an amino acid sequence at least [***]% identical to the aforementioned
polypeptide sequences.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

5

 

1.21.                     “[***]-MAY Conjugate” shall mean any
conjugate of an [***] Antibody
with a MAY Compound.

 

1.22.                     “Dedicated Equipment” shall mean any equipment, instrument or
machinery used by ImmunoGen exclusively in the manufacturing of Preclinical
Materials or Clinical Materials.

 

1.23.                     “Development” and “Develop” shall mean, with respect
to any Licensed Product, all activities with respect to such Licensed Product
relating to research and development in connection with seeking, obtaining
and/or maintaining any Regulatory Approval for such Licensed Product in the
Field in the Territory, including without limitation, all pre-clinical research
and development activities, test method development and stability testing,
toxicology, formulation, process development, manufacturing scale-up,
development-stage manufacturing, quality assurance/quality control development
and performance, all activities relating to developing the ability to
manufacture any Licensed Product or any component thereof (including, without
limitation, process development work), and all other activities relating to
seeking, obtaining and/or maintaining any Regulatory Approvals from the FDA
and/or any Foreign Regulatory Authority and Adverse Drug Experience reporting.

 

1.24.                     “Drug Approval Application” shall
mean any application for Regulatory Approval (including pricing and
reimbursement approvals) required prior to any commercial sale or use of a
Licensed Product in any country or jurisdiction in the Territory, including,
without limitation, (a) any BLA, NDA or other regulatory application filed with
the FDA prior to any commercial sale or use of a Licensed Product in the United
States, and (b) any MAA or other equivalent regulatory application filed with
any Foreign Regulatory Authority for Regulatory Approval (including pricing and
reimbursement approvals) required prior to any commercial sale or use of a
Licensed Product in any other country or jurisdiction in the Territory.

 

1.25.                     “Effective Date” shall mean the date
first written above in the introductory paragraph to this Agreement.

 

1.26.                     “EMEA” shall mean the European Medicines
Agency and any successor agency or authority thereto.

 

1.27.                     “FDA” shall mean the United States
Food and Drug Administration and any successor agency or authority thereto.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

6

 

1.28.                     “Field” shall mean all human
therapeutic, diagnostic and prophylactic uses.

 

1.29.                     “First Commercial Sale” shall mean
the date of the first commercial transfer or disposition to a Third Party of a
Licensed Product by or on behalf of Biogen Idec or any Affiliate or Sublicensee
of Biogen Idec.

 

1.30.                     “Foreign Regulatory Authority” shall
mean the EMEA and any other applicable supranational, national, federal, state
or local regulatory agency, department, bureau or other governmental entity of
any country or jurisdiction in the Territory (other than the FDA in the United
States), having responsibility in such country or jurisdiction for any
Regulatory Approvals of any kind in such country or jurisdiction, and any successor
agency or authority thereto.

 

1.31.                     “Full Time Equivalent” or “FTE” shall mean the equivalent of one
person-year of work on the Research Program, consisting of [*****]
or [*************], and which is carried
out by employees, contractors or agents of ImmunoGen having the appropriate
scientific expertise to conduct such activities.  For the purposes of this Agreement, [***] person [***] be [***] as [***] than [***]  [***] in any
given year.

 

1.32.                     “FTE Cost” shall mean, for any period
during the Term of this Agreement, the FTE Rate multiplied by the number of
FTEs expended over such period.

 

1.33.                     “FTE Rate” shall mean, for the [***]  [***]  [***] Contract Year commencing on the Effective Date, [***]; and, for each Contract Year thereafter, the result
obtained by multiplying [***] by the
sum of (1+CPI) where CPI is a fraction, the numerator of which is the
difference between the Consumer Price Index as of the last month of the
immediately preceding Contract Year and the Consumer Price Index as of the
month immediately preceding the Effective Date and the denominator of which is
the Consumer Price Index as of the month immediately preceding the Effective
Date.

 

1.34.                     “GMPs” shall mean all good
manufacturing practices under Title 21 of the United States Code of Federal
Regulations, as amended from time to time.

 

1.35.                     “Gross Sales” shall mean the gross amount invoiced by Biogen
Idec or its Affiliates or Sublicensees for sales of a Licensed Product to Third
Parties in the Territory, including sales to distributors.  Note for purposes of clarification, Gross
Sales will include Biogen Idec’s revenue from distributors, and not revenue of
the distributors themselves.  A sale

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

7

 

or transfer of a Licensed Product by Biogen Idec to one of its
Affiliates or Sublicensees shall not be considered a sale to a Third Party for
the purpose of this provision but the resale of such Licensed Product by such
Affiliate or Sublicensee to a Third Party shall be a sale for such purposes.  In the event the Licensed Product is sold in
the form of a Combination Product, Gross Sales will be determined by
multiplying actual Gross Sales of such Combination Product by the fraction A/(A
+ B), where A is the invoice price of the Licensed Product, if sold separately,
and B is the invoice price of any other active component or components in the
combination, if sold separately, in each case in the same country and in the
same class, purity and dosage as in the Combination Product.  If, on a country-by-country basis, the other
active component or components in the combination are not sold separately in
such country, Gross Sales shall be calculated by multiplying actual Gross Sales
of such Combination Product by the fraction A/C where A is the invoice price of
the Licensed Product if sold separately, and C is the invoice price of the
Combination Product, in each case in the same country and in the same class,
purity and dosage as in the Combination Product.  If, on a country-by-country basis, the
Licensed Product component of the Combination Product is not sold separately in
such country, but the other active component or components are sold separately,
Gross Sales shall be calculated by multiplying actual Gross Sales of such
Combination Product by the fraction (C-B)/C where B is the invoice price of the
other active component or components, if sold separately, and C is the invoice
price of the Combination Product, in each case in the same country and in the
same class, purity and dosage as in the Combination Product.  If, on a country-by-country basis, neither
the Licensed Product nor the other active component or components of the
Combination Product is sold separately in such country, Gross Sales, for such
Combination Product shall be determined by the Parties in good faith.

 

1.36.                     “ImmunoGen Materials” shall mean any
Proprietary Materials Controlled by ImmunoGen and used by ImmunoGen, or
provided by ImmunoGen for use, in the Research Program.  ImmunoGen Materials shall include, without
limitation, any MAY Compound.

 

1.37.                     “ImmunoGen Program Technology” shall
mean any Program Technology made solely by employees of, or agents or others
obligated to assign inventions to, ImmunoGen or an ImmunoGen Affiliate.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

8

 

1.38.                     “Improvements” shall mean, collectively,
[********************], Licensed
Technology Improvements, [*************]
and MAY Compound Improvements.

 

1.39.                     “IND” shall mean an investigational
new drug application (as defined in Title 21 of the United States Code of
Federal Regulations, as amended from time to time) filed or to be filed with
the FDA with regard to any Licensed Product.

 

1.40.                     “Indemnitees” and “Indemnifying Party” shall have the
meanings set forth in Section 9.

 

1.41.                     “Joint Program Technology” shall
mean any Program Technology made jointly by at least one employee or agent to,
or other person obligated to assign inventions to, ImmunoGen or an ImmunoGen
Affiliate, and by at least on employee or agent to, or other person obligated
to assign inventions to, Biogen Idec or a Biogen Idec Affiliate.

 

1.42.                     “Licensed Patent Rights” shall mean
any Patent Rights which are Controlled by ImmunoGen or its Affiliates as of the
Effective Date or become Controlled by ImmunoGen or its Affiliates during the
Term (including without limitation ImmunoGen’s interest in any Improvements
Controlled by ImmunoGen or an ImmunoGen Affiliate, and ImmunoGen Program
Technology and Joint Program Technology covered by Patent Rights), to the
extent necessary or useful to Develop, have Developed, Commercialize, have
Commercialized, make, have made, use, have used, sell, have sold, offer for
sale, import, have imported, export and have exported any [***]-MAY
Conjugate in the Field in the Territory. 
Certain Licensed Patent Rights existing as of the Effective Date are set
forth in Schedule A attached hereto and incorporated herein by
reference.

 

1.43.                     “Licensed Product” shall mean any
product (a) that incorporates, is comprised of, or is otherwise derived from
Licensed Technology, or (b) the Development, Commercialization, manufacture,
use, sale, offer for sale, importation or exportation of which would, but for
the license granted herein, infringe a Valid Claim of the Licensed Patent
Rights.

 

1.44.                     “Licensed Technology” shall mean any
Technology which is Controlled by ImmunoGen or its Affiliates as of the
Effective Date or becomes Controlled by ImmunoGen of its Affiliates during the
Term (including without limitation ImmunoGen’s
interest in any Improvements Controlled by ImmunoGen or its Affiliates,
ImmunoGen Program Technology and Joint Program Technology), which is
necessary or useful for the Development,

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

9

 

Commercialization, manufacture, use, sale, offer for sale, import or
export of any [***]-MAY Conjugate in the Field
in the Territory.

 

1.45.                     “Licensed Technology Improvements” shall mean any
Technology (including without limitation any Program Technology), other than [*******]  [***], MAY
Compound Improvements or [*****]  [*****], conceived or reduced to practice in the course of
Development of Licensed Products as a result of the use of Licensed Technology
or Licensed Patent Rights or ImmunoGen Materials, that is an enhancement,
improvement or modification to the Licensed Technology or to an invention
claimed in the Licensed Patent Rights.  Licensed Technology Improvements does not
include modifications related to humanization or other structural
modifications, formulation, method of use, administration or delivery of an
Antibody.

 

1.46.                     “[*****************]” shall
mean any Program Technology that is an [***], [***] or [***] to [***] useful for [***] a [***] or [********],
such as a [*******], to [***]
or other [***********].

 

1.47.                     “MAA” shall mean an application
filed with the EMEA to market and sell any Licensed Product in the European
Union or any country or territory therein for a particular indication within
the Field.

 

1.48.                     “MAY Compound” shall mean any and
all maytansinoid compounds, including, without limitation (a) N2’-deacetyl-N2’-(3-mercapto-1-oxopropyl)-maytansine
(CAS No. 139504-50-0) (commonly referred to as DM1); (b) N2’-deacetyl-N2-(4-mercapto-1-oxopentyl)-maytansine
(commonly referred as DM3); and (c) N2’-deacetyl-N2-(4-mercapto-4-methyl-1-oxopentyl)-maytansine
(commonly referred as DM4), and all fragments, variants and derivatives of such
maytansinoid compounds.

 

1.49.                     “MAY Compound Improvements”
shall mean any Technology (including without limitation any Program Technology)
conceived or reduced to practice in the course of Development of Licensed
Products, that is an enhancement, improvement or modification of a MAY
Compound, and any compositions or methods useful for the manufacture of such
MAY Compound.

 

1.50.                     “MTA” shall mean that
certain Material Transfer and Evaluation Agreement between Biogen, Inc. and
ImmunoGen dated [***], [***],
as amended by amendments dated [***], [***], [***], [***], [***], [***] and [***], [***].

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

10

 

1.51.                     “NDA” shall mean a new drug
application (as defined in Title 21 of the United States Code of Federal
Regulations, as amended from time to time) filed with the FDA seeking
Regulatory Approval to market and sell any Licensed Product in the United
States for a particular indication within the Field.

 

1.52.                     “Net Sales” shall mean Gross Sales of a Licensed Product
less applicable Sales Returns and Allowances.

 

1.53.                     “Patent Rights” shall mean the
rights and interests in and to any and all issued patents and pending patent
applications (including inventor’s certificates, applications for inventor’s
certificates, statutory invention registrations, applications for statutory
invention registrations, utility models, and any foreign equivalents thereof)
in any country or jurisdiction in the Territory, including any and all
provisionals, non-provisionals, substitutions, continuations,
continuations-in-part, divisionals and other continuing applications,
supplementary protection certificates, renewals, and all letters patent on any
of the foregoing, and any and all reissues, reexaminations, extensions,
confirmations, registrations and patents of addition on any of the foregoing.

 

1.54.                     “Phase II Clinical Trial” shall
mean, as to a particular Licensed Product for a particular indication, a
controlled and lawful study in humans of the safety, dose ranging and efficacy
of such Licensed Product for such indication, which is prospectively designed
to generate sufficient data (if successful) to commence a Pivotal Clinical
Trial of such Licensed Product for such indication.

 

1.55.                     “Pivotal Clinical Trial”
shall mean, as to a particular Licensed Product for a particular indication, a
controlled and lawful study in humans of the safety and efficacy of such
Licensed Product for such indication, which is prospectively designed to
demonstrate statistically whether such Licensed Product is safe and effective
for use in such indication in a manner sufficient to file an NDA or BLA to
obtain Regulatory Approval to market and sell that Licensed Product in the
United States or in any other country in the Territory for the indication under
investigation in such study.

 

1.56.                     “Preclinical Materials” shall mean any MAY Compound and/or [***]-MAY Conjugates supplied by ImmunoGen
to Biogen Idec under Section 4.2 for the purpose of conducting research
activities and/or preclinical testing with respect to a Licensed Product.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

11

 

1.57.                     “Program Technology” shall mean any Technology, whether or not
patentable, conceived or reduced to practice in the conduct of the Research
Program, or during manufacture of Preclinical Material or Clinical Material.

 

1.58.                     “Proprietary Materials” shall mean any
tangible chemical, biological or physical research materials that are furnished
by or on behalf of one Party to the other Party in connection with this
Agreement, regardless of whether such materials are specifically designated as
proprietary by the transferring Party.

 

1.59.                     “Regulatory Approval” shall mean any
and all approvals (including pricing and reimbursement approvals), product and
establishment licenses, registrations or authorizations of any kind of any
Regulatory Authority necessary for the development, pre-clinical and/or human
clinical testing, manufacture, quality testing, supply, use, storage, importation,
export, transport, marketing and sale of a Licensed Product (or any component
thereof) for use in the Field in any country or other jurisdiction in the
Territory.

 

1.60.                     “Regulatory Authority” shall mean the
FDA and/or a Foreign Regulatory Authority.

 

1.61.                     “Research Plan” shall mean the written plan describing the research
activities to be carried out by each Party pursuant to this Agreement.

 

1.62.                     “Research Program” shall mean the research activities in the Field
commencing after the Effective Date to be conducted by the Parties pursuant to
Section 3.1 of this Agreement and reflected in the Research Plan.

 

1.63.                     “Sales Returns and Allowances” shall mean the sum of (a) and (b), where: (a) is
a provision, determined by Biogen Idec under U.S. GAAP for sales of Licensed
Product in the Territory for (i) trade, cash and quantity discounts on Licensed
Product (other than price discounts granted at the time of invoicing and which
are already included in the determination of Gross Sales), (ii) credits or allowances
given or made for rejection or return of previously sold Licensed Product or
for rebates or retroactive price reductions (including Medicare, Medicaid and
similar types of rebates and chargebacks), (iii) taxes, duties or other
governmental charges levied on or measured by the billing amount for Licensed
Product, as adjusted for rebates and refunds (excluding income and franchise
taxes), (iv) charges for freight and insurance directly related to the
distribution of Licensed Product, to the extent included in Gross Sales, and
(v)

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

12

 

credits for allowances given or made for wastage replacement, indigent
patient and any other sales programs for Licensed Product to the extent the
sale of the Licensed Product was included in Gross Sales and the credit is
applied against such Gross Sales; and (b) is a periodic adjustment of the
provision determined in (a) to reflect amounts actually incurred by Biogen Idec
in the Territory for items (i), (ii), (iii), (iv) and (v) in clause (a).

 

1.64.                     “Sublicensee” shall mean any Third
Party expressly sublicensed by Biogen Idec
in accordance with Section 2.1(a)(ii) of this Agreement.  A Sublicensee shall not include (a) a
distributor or other Third Party who purchases Licensed Products for the sole
purpose of selling such Licensed Products but not to make, have made or
formulate Licensed Product (other than a license to perform final packaging of
Licensed Product) or (b) a Third Party who primarily performs sales and/or
marketing activities with respect to such Licensed Products.

 

1.65.                     “Target” shall mean any antigen with
which a particular Antibody interacts, and any fragment, peptide or epitope
thereof.

 

1.66.                     “Technology” shall mean and include
any and all unpatented proprietary ideas, trade secrets, inventions,
discoveries, data, results, formulae, designs, specifications, methods,
processes, formulations, techniques, know-how, technical information
(including, without limitation, structural and functional information), process
information, pre-clinical information, clinical information, and any and all
proprietary biological, chemical, pharmacological, toxicological, pre-clinical,
clinical, assay, control and manufacturing data and materials.

 

1.67.                     “Term” shall mean the period
commencing on the Effective Date and continuing until the expiration or
termination of this Agreement in accordance with the terms hereof.

 

1.68.                     “Territory” shall mean all countries
and jurisdictions of the world.

 

1.69.                     “Third Party”, as to a Party, shall
mean any entity other than the Party and its respective Affiliates.

 

1.70.                     “Third Party Payments” shall have
the meaning set forth in Section 5.3(b).

 

1.71.                     “Upfront Fee” shall have the meaning set
forth in Section 5.1(a).

 

1.72.                     “Valid Claim” shall mean a claim (i)
of any issued, unexpired patent within the Licensed Patent Rights that (a) has
not been finally cancelled, withdrawn, abandoned or rejected by any
administrative agency or other body of competent jurisdiction, or (b) has not
been revoked, held invalid, or declared unpatentable or unenforceable in a
decision of a court or other

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

13

 

body of competent jurisdiction that is unappealable or unappealed
within the time allowed for appeal, or (c) has not been rendered unenforceable
through disclaimer or otherwise, or (d) is not lost through an interference
proceeding; or (ii) of any patent application within the Licensed Patent Rights
that shall not have been (a) cancelled, withdrawn, abandoned, or (b) been
pending for more than [***] ([***]) years.

 

2.                                      GRANT OF RIGHTS

 

2.1                               License
Grants.

 

(a)                                   Commercialization
License.

 

(i)                                     License
to Biogen Idec.  Subject to the terms
and conditions of this Agreement, ImmunoGen hereby grants to Biogen Idec an
exclusive, royalty-bearing license, including the right to grant sublicenses as
described in Section 2.1(a)(ii) below, under the Licensed Patent Rights
and Licensed Technology, to Develop, have Developed, Commercialize, have
Commercialized, make, have made, use, have used, sell, have sold, offer for
sale, import, have imported, export and have exported Licensed Products in the
Field in the Territory.  Biogen Idec
shall have the full and unrestricted right to extend the licenses granted under
this Section 2.1(a)(i) and elsewhere under this Agreement to its
Affiliates.  Biogen Idec shall promptly
advise ImmunoGen in writing of any such extension to its Affiliates.  [***] shall be
responsible for paying any royalty obligations that ImmunoGen may have to any
of its Affiliates or to any Third Party under agreements between ImmunoGen and
such Affiliates or Third Parties in effect as of the Effective Date arising
from the license grant herein.

 

(ii)                                  Right
to Sublicense.  Biogen Idec shall
have the right freely to grant sublicenses to all or any portion of its rights
under the license rights granted pursuant to Section 2.1(a)(i) hereof to
any Third Party; provided, however, that (1) ImmunoGen shall be
notified in writing of each such sublicense, (2) any and all sublicenses shall
be consistent with the terms and conditions of this Agreement, and (3) Biogen
Idec shall remain obligated for the payment to ImmunoGen of all of its payment
obligations hereunder, including, without limitation, the payment of any
milestones and royalties described in Section 5 hereof.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

14

 

(b)                                  Research
Licenses.

 

(i)                                     Research License to Biogen Idec.  Subject
to the terms and conditions of this Agreement, during the Term of this
Agreement, ImmunoGen hereby grants to Biogen Idec a fully paid up,
non-exclusive, royalty free, worldwide license, without the right to grant
sublicenses, under the Licensed Technology and Licensed Patent Rights for the
sole purpose of conducting the activities required in the performance of its
obligations hereunder as part of the Research Program.

 

(ii)                                  Research
License to ImmunoGen.  Subject to the terms and conditions of this
Agreement, during the Term of this Agreement, Biogen Idec hereby grants to
ImmunoGen a paid-up, non-exclusive, royalty-free, worldwide license, without
the right to grant sublicenses, under the Biogen Idec Background Technology and
Biogen Idec Patent Rights and Biogen Idec’s interest in any Improvements Controlled
by Biogen Idec or its Affiliates, Biogen
Idec Program Technology and Joint Program Technology, for the sole purpose of
conducting the activities required in the performance of its obligations
hereunder as part of the Research Program.

 

2.2                               Retained Rights and Covenants.

 

(a)                                   Retained
Rights.  Subject to the other terms
of this Agreement (including, without limitation, Sections 2.2(b) and
2.3), ImmunoGen retains the right to use the Licensed Technology and
Improvements Controlled by ImmunoGen and practice the Licensed Patent Rights
(i) to perform its obligations under this Agreement (including without
limitation its obligation to manufacture Preclinical Materials and Clinical
Materials in accordance with Section 4 of this Agreement) (ii) to develop,
have developed, commercialize, have commercialized, make, have made, use, have
used, sell, have sold, offer for sale, import, have imported, export and have
exported any product that does not contain a conjugate of a MAY Compound to an
Antibody which selectively and specifically binds with a protein encoded by a gene
within the [***] Gene Family, and (iii) for
any and all uses outside of the Field.

 

(b)                                  Covenants.  Notwithstanding anything to the contrary
contained in this Agreement, ImmunoGen hereby agrees during the Term of this
Agreement, that it shall not (i) grant to any Third Party any license or other
right under any Patent Rights, Improvements or Technology Controlled by
ImmunoGen or its Affiliates to develop, have developed, commercialize, have
commercialized, make, have made, use, have used, sell, have sold, offer for

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

15

 

sale, import, have imported, export and have exported
any product containing a conjugate of a MAY Compound to an Antibody which
selectively and specifically binds with a protein encoded by a gene within the [***] Gene Family, or (ii) outside the performance of its
obligations under this Agreement, develop, have developed, commercialize, have
commercialized, make, have made, use, have used, sell, have sold, offer for
sale, import, have imported, export and have exported any products containing a
conjugate of a MAY Compound to an Antibody which selectively and specifically
binds with a protein encoded by a gene within the [***]
Gene Family.

 

2.3                               Improvement
Licenses.

 

(a)                                   License to ImmunoGen.  Biogen
Idec hereby grants to ImmunoGen a non-exclusive, fully paid, irrevocable,
royalty-free license, including, except as set forth below, the right to grant
sublicenses, (i) under Biogen Idec’s interest in Improvements Controlled by
Biogen Idec or its Affiliates to manufacture Clinical Materials or Preclinical
Materials pursuant to the terms of this Agreement, and/or each applicable
Supply Agreement, (ii) under Biogen Idec’s interest in [**********],
MAY Compound Improvements, and Licensed Technology Improvements, Controlled by
Biogen Idec or its Affiliates, to develop, have developed, commercialize, have
commercialized, make, have made, use, sell, have sold, offer for sale, import,
have imported, export, and have exported any product that is conjugated to a
MAY Compound that is not a conjugate of a MAY Compound to an Antibody which
selectively and specifically binds with a protein encoded by a gene within the [***] Gene Family, and (iii) under Biogen Idec’s interest in
MAY Compound Improvements and Licensed Technology Improvements Controlled by
Biogen Idec or its Affiliates to exploit such MAY Compound Improvements and
Licensed Technology Improvements for any and all uses outside of the
Field.  The licenses granted under Biogen
Idec’s interest in Improvements Controlled by Biogen Idec or its Affiliates are
limited to such Improvements only. 
Notwithstanding the foregoing, ImmunoGen shall only be permitted to
sublicense rights to Improvements granted by Biogen Idec under this Section
2.3(a) to any Third Party which has entered into an agreement with ImmunoGen
involving the license to such Third Party of ImmunoGen’s Technology used in the
conjugation of maytansine derivatives to binding proteins (“ImmunoGen MAY
Technology”)

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

16

 

and which contains Substantially Similar Grant Back
Rights (as defined below) (each such Third Party, a “Qualified ImmunoGen MAY
Licensee”).  For purposes of this
Agreement, “Substantially Similar Grant Back Rights” shall mean the grant by a Qualified
ImmunoGen MAY Licensee to ImmunoGen of a non-exclusive license to MAY
Improvement Patent Rights (as defined below) with the right to sublicense to
all other Qualified ImmunoGen MAY Licensees, the grant by a Qualified ImmunoGen
MAY Licensee of a non-exclusive license to MAY Improvement Patent Rights (as
defined below) to all other Qualified ImmunoGen MAY Licensees, or the ownership
by ImmunoGen of MAY Improvement Patent Rights, which ownership results in
ImmunoGen Controlling such MAY Improvement Patent Rights.  For purposes of the foregoing, “MAY
Improvement Patent Rights” shall mean Patent Rights which are (a) discovered by (or on behalf of) such
Qualified ImmunoGen MAY Licensee through the use of ImmunoGen MAY Technology
and (b) which represent an enhancement or improvement to ImmunoGen MAY
Technology.  Nothing in this Agreement or
the course of dealings between the Parties or usage or custom in the industry
or trade shall be construed to confer any other rights or licenses to any other
intellectual property Controlled by Biogen Idec or its Affiliates by
implication, estoppel or otherwise.

 

(b)                                  Licenses
to Biogen Idec.  ImmunoGen hereby
grants to Biogen Idec (i) a perpetual, worldwide, non-exclusive, fully paid,
irrevocable, royalty-free license, including the right to [*******], under
ImmunoGen’s interest in [************] Controlled
by ImmunoGen or its Affiliates to develop, have developed, commercialize, have
commercialized, make, have made, use, sell, have sold, offer for sale, import,
have imported, export and have exported [*****************************]
for [***] and [***] and
(ii) a [******************] (even as to
ImmunoGen) [*******************************],
under ImmunoGen’s interest in [*****]
Controlled by ImmunoGen or its Affiliates, to develop, have developed,
commercialize, have commercialized, make, have made, use, sell, have sold,
offer for sale, import, have imported, export and have exported [********] for [***] and [***].  The licenses
granted under ImmunoGen’s interest in Improvements Controlled by ImmunoGen or
its Affiliates are limited to such Improvements only.  Nothing in this Agreement or the course of
dealings between the Parties or usage or custom in the industry or trade shall
be construed to

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

17

 

confer any other rights or licenses to any other
intellectual property Controlled by ImmunoGen or its Affiliates by implication,
estoppel or otherwise.

 

2.4                               Right to [************************]. 
In accordance with and
subject to this Section 2.4, Biogen Idec shall have the right, at any time
during the period commencing on the Effective Date and continuing until [***], [***] (the “[**********************]”) to [***]
that ImmunoGen [***] into an [****************]
on [***************]  to the [***] set forth
in this [***] (each, an “[*********************]”)
with respect to any Antibody (other than an [***]
Antibody) and Target (each, a “[*******]”) by
providing a written notice to ImmunoGen, which notice shall specify in
reasonable detail the [*******] that
it wishes to be the subject of an [*************]
(the “[*************]”).  ImmunoGen shall provide a written notice to
Biogen Idec within [***] ([***]) days of its receipt of any [*************]
specifying whether or not it wishes to [***] into an [*************] with respect to the [******]
(the “[**********]”).  In the event that ImmunoGen indicates in its [*************]  that
it [***] to the [***]
of an [*************] with respect to the [******] described in the [*************],
the Parties shall negotiate in good faith an [*************]
in the form of [*****] with respect to the [*****].  If in the [*************], ImmunoGen indicates that it does not wish
to [***] into an [*************]
with respect to the [*****]
described in the [*************], ImmunoGen shall
have no further obligations to Biogen Idec under this Section 2.4 with
respect to the [*****] described in the [*************]. 
Notwithstanding anything to the contrary set forth in this Agreement,
the Parties hereby agree that (a) on and after the expiration of the [****************], ImmunoGen shall have no further
obligations to Biogen Idec under this Section 2.4 and (b) Biogen Idec shall
have the right to select and maintain no more than [***]
([***]) [*****************************]
(in addition to [******]).

 

3.                                      RESEARCH PROGRAM; DEVELOPMENT AND COMMERCIALIZATION

OF LICENSED PRODUCTS

 

3.1                               Research Program.

 

(a)                                   Implementation of
Research Program.  As soon as practicable after the Effective Date, the Parties shall prepare
a Research Plan which shall set forth with reasonable specificity the
research objectives and tasks to be conducted by the Parties under the Research

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

18

 

Program, which shall be designed to facilitate the
selection of the appropriate [***]
Antibodies and MAY Compound to be used in preparing the [***]-MAY
Conjugate.  Without limiting the
foregoing, to the extent that Biogen Idec requests that ImmunoGen manufacture
Preclinical Materials and Clinical Materials, ImmunoGen shall, in consultation
with Biogen Idec, as part of the Research Program, conduct all process
development activities as ImmunoGen determines in its discretion are reasonably
necessary to produce the quantities of Preclinical Materials and Clinical
Materials so ordered, which process development activities shall be [***] within the [***] of [***] to be [***] by Biogen
Idec pursuant to Sections 4.2 and 4.3 of this Agreement, provided that [******] shall have [***]-[***] the [***] for such [******] activities. 
The Parties acknowledge and agree that Biogen Idec shall have the final
decision making authority with respect to the establishment of, additions to
and modifications of the Research Plan, provided that allocation of activities
specifically to ImmunoGen under the Research Plan, including any amendments or
updates to such activities, shall be subject to ImmunoGen’s prior written
consent, which consent shall not be unreasonably withheld.  Each Party agrees that the activities
assigned to it in the Research Plan shall be conducted diligently and in good
scientific manner in accordance with accepted laboratory practices and in
compliance with any and all laws, regulations and bioethical conventions
applicable to the jurisdiction in which those activities take place.

 

(b)                                  Collaborative
Efforts and Reports.  The Parties
agree that the successful execution of the Research Program will require the
collaborative use of both Parties’ areas of expertise.  The Parties shall keep the Collaboration
Committee and each other fully informed about the status of the Research
Program.  Scientists at ImmunoGen and
Biogen Idec shall cooperate in the performance of the Research Program and,
subject to any confidentiality obligations to Third Parties, shall exchange information
and materials in a mutually acceptable secure manner as necessary to carry out
the Research Program, but subject to the provisions of Section 6
hereof.  The Parties expect that such
exchange of information and materials may involve short-term on-site visits (up
to a few weeks) by scientists of each Party to the facilities of the other
Party.

 

(c)                                   Additional
Obligations of ImmunoGen.  Subject to the other terms of this Agreement,
ImmunoGen may, [***]  [***]
[***]  [***],
conduct such additional research

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

19

 

activities that ImmunoGen
determines, in its sole discretion are necessary or useful for the Development
of Licensed Products.  ImmunoGen shall
provide Biogen Idec with all information and materials Controlled by ImmunoGen
resulting from such research activities. 
Without limiting the generality of the foregoing, at Biogen Idec’s
request, ImmunoGen shall from time to time, provide Biogen Idec with technical
assistance within ImmunoGen’s area of expertise (or its subcontractors)
concerning the Development of Licensed Products, provided that such technical
assistance and expertise is within the scope of the Licensed Technology and/or
Licensed Patent Rights covered under this Agreement.  Such technical assistance and expertise shall
include, but not be limited to, visits by ImmunoGen personnel to Biogen Idec
and visits by Biogen Idec personnel to ImmunoGen (or its subcontractors), at
Biogen Idec’s expense, at such times and for such periods of time as may be
reasonably acceptable to the Parties.

 

(d)                                  Supply
of Proprietary Materials.  From time
to time during the Research Program, either Party (the “transferring Party”)
may supply the other Party (the “recipient Party”) with its Proprietary
Materials for use in the Research Program. 
In connection therewith, the recipient Party hereby agrees that (i) it
shall not use Proprietary Materials for any purpose other than exercising any
rights specifically granted to it or reserved by it hereunder; (ii) it shall
use the Proprietary Materials only in compliance with all applicable, federal,
state, and local laws and regulations; (iii) it shall not transfer any
Proprietary Materials to any Third Party without the prior written consent of
the transferring Party, except as expressly permitted hereby or by Article 6;
(iv) the transferring Party shall retain full ownership of all such Proprietary
Materials; and (v) upon the expiration or termination of this Agreement, the
recipient Party shall at the instruction of the transferring Party either
destroy or return any Proprietary Materials which are not the subject of the
grant of a continuing license hereunder.

 

(e)                                   Transition
of Services Being Provided by ImmunoGen. 
In the event that ImmunoGen fails to carry out its material
obligation(s) under Section 3.1(a), 3.2(b) 4.2 or 4.3 of this Agreement, (i)
Biogen Idec shall provide ImmunoGen with written notice which shall identify
such material obligation(s) and (ii) solely to the extent ImmunoGen fails to
remedy such failure on or before [***] ([***]) days of receipt of such notice, Biogen Idec may, in
addition to other remedies available to it under this Agreement at law and in
equity, assume such obligations which ImmunoGen has failed to carry out under
such Sections or assign them to a Third Party.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities Exchange
Act of 1934.

 

20

 

ImmunoGen agrees to reasonably cooperate with Biogen
Idec in the transition of its activities under this Section 3.1(e) to Biogen
Idec or a Third Party as contemplated by the preceding sentence, such
cooperation to include without limitation using commercially reasonable efforts
to [**************************] of [********] to permit Biogen Idec or a Third Party to carry
out the activities transitioned under this Section 3.1(e).  Upon completion of the transition of
activities set forth above, the Parties shall negotiate in good faith an [****************] to any provisions related to [***] and [***] from
Biogen Idec to ImmunoGen under this Agreement to [***]
for the [***] of such services.

 

3.2                               Development and
Commercialization.

 

(a)                                   Responsibility.  Subject to Section 3.3 of
this Agreement, on and after the Effective Date, Biogen Idec shall have sole
control and authority over the Development and Commercialization of Licensed
Products in the Field in the Territory, including, without limitation, (i)
research and all pre-clinical Development activities (including the assessment
of alternative designs for the [***]-MAY
Conjugate, the selection of the final [***] Antibody
and MAY Compound to be used in the [***]-MAY
Conjugate and the selection of the [***]-MAY
Conjugate to be Developed as a Licensed Product, all preclinical and
IND-enabling studies, including toxicology testing, any pharmaceutical
development work on formulations or process development relating to any such
Licensed Product), (ii) all activities related to human clinical trials
(including any Phase II Clinical Trials and/or Pivotal Trials), (iii) subject
to Section 4 of this Agreement, all activities relating to manufacture and
supply of all [***] Antibodies, all MAY
Compounds, all [***]-MAY Conjugates and all
Licensed Products, to the extent such activities relate to the Development and
Commercialization of Licensed Products (including all required process
development and scale up work with respect thereto), (iv) all
Commercialization, activities relating to any Licensed Product, and (v) all
activities relating to any regulatory filings, registrations, applications and
Regulatory Approvals relating to any of the foregoing (including any INDs or
foreign equivalents, any manufacturing facility validation and/or licensure,
any Drug Approval Applications and any

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

21

 

other Regulatory
Approvals).  Biogen Idec shall own all
Technology arising from any such activities under this Agreement as well as all
regulatory filings, registrations, applications and Regulatory Approvals
relating to Licensed Products (including any INDs or foreign equivalents, any
Drug Approval Applications and any other Regulatory Approvals), and all of the
foregoing Technology, filings, registrations, applications and Regulatory
Approvals relating to Licensed Products shall be considered Confidential
Information solely owned by Biogen Idec. 
Notwithstanding the foregoing, ImmunoGen shall own all Technology
arising from ImmunoGen’s activities relating to the manufacture and supply of
MAY Compounds and Licensed Products to Biogen Idec, and all such Technology
shall be considered Confidential Information solely owned by ImmunoGen.  All activities relating to Development and
Commercialization of Licensed Products under this Agreement shall be undertaken
at Biogen Idec’s sole cost and expense, except as otherwise expressly provided
in this Agreement.

 

(b)                                  Licensed Technology and Information – Regulatory
Authorities and Manufacturing.  ImmunoGen shall disclose and make available
to Biogen Idec in a timely manner all Licensed Technology requested by Biogen
Idec for use by Biogen Idec, its Affiliates and Sublicensees in connection with
Development and Commercialization activities and filings with Regulatory
Authorities including, without limitation, the Licensed Technology relating to
the manufacture and supply of MAY Compounds and Licensed Products owned by
ImmunoGen under Section 3.2(a) and other Confidential Information and
Proprietary Materials of ImmunoGen.  Upon
request by Biogen Idec and at Biogen Idec’s expense, ImmunoGen shall transfer
to Biogen Idec (and/or a Third Party designated by Biogen Idec) all
manufacturing-related Licensed Technology (including without limitation
Confidential Information, Proprietary Materials, batch records, assays and
SOPs) necessary or useful for Biogen Idec and/or its designee to manufacture
and supply Licensed Product and related materials (including without
limitation, the MAY Compound and the [***]-MAY
Conjugate, Preclinical Materials and Clinical Materials) and ImmunoGen shall
use commercially reasonable efforts to ensure that such transfer of Licensed
Technology is completed promptly following each such Biogen Idec request.

 

(c)                                   Due Diligence.  Biogen Idec will use
commercially reasonable efforts to Develop Licensed Products, and to undertake
investigations and actions required to obtain appropriate Regulatory Approvals
necessary to market Licensed Products, in the Field and in the Territory and,
if approved, to Commercialize Licensed Products, such commercially reasonable efforts to be in accordance with
the efforts and resources Biogen Idec would use for a compound

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

22

 

owned by it or to which it has
rights, which is of similar market potential at a similar stage in development
as the applicable Licensed Product, taking into account the proprietary
position of the Licensed Product, the relative potential safety and efficacy of
the Licensed Product, the regulatory requirements involved in its Development,
Commercialization and Regulatory Approval,  the cost of goods and
availability of capacity to manufacture and supply the Licensed Product at commercial
scale, and other relevant factors including, without limitation, technical,
legal, scientific or medical factors.

 

3.3                               Updates and Reports;
Notification of Milestones; Exchange of Adverse Drug Experience Information.

 

(a)                                   Updates and Reports.  Biogen
Idec shall keep ImmunoGen reasonably informed of the progress of Biogen Idec’s
efforts to Develop and Commercialize Licensed Products in the Field in the
Territory by providing ImmunoGen with brief written reports no less frequently
than on or about December 31 of each year during the Term of this Agreement
(other than December 31, 2004) which shall summarize Biogen Idec’s efforts to
so Develop and Commercialize Licensed Products hereunder, identify the Drug
Approval Applications with respect to any Licensed Product that Biogen Idec and
its Affiliates and Sublicensees have filed, sought or obtained in the prior
twelve (12)-month period, and any they reasonably expect to make, seek or
attempt to obtain in the following twelve (12)-month period.

 

(b)                                  Notification of
Milestone Achievement.  Biogen Idec shall provide ImmunoGen with prompt
written notice of the occurrence of any event giving rise to an obligation to
make a milestone payment to ImmunoGen under Section 5.1(b), which shall in
any event be no later than ten (10) business days after the occurrence of such
event, and shall provide ImmunoGen with prompt written notice of the occurrence
of the First Commercial Sale of any particular Licensed Product.  In the event that, notwithstanding the fact
that Biogen Idec has not given any such notice, ImmunoGen believes any such
milestone event has occurred, it shall so notify Biogen Idec in writing, and
shall provide to Biogen Idec the data and information demonstrating that the
conditions for payment have been achieved. 
Within ten (10) business days of its receipt of such notice, the Parties
shall meet to review the data and information and shall agree in good faith
whether or not the conditions for payment have been achieved.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

23

 

(c)                                   Adverse Drug Experiences.  The
Parties agree to negotiate in good faith a safety data exchange agreement
within a commercially reasonable period of time before the commencement of a
first human clinical trial with Licensed Products, such agreement to cover,
among other things, information sharing between the Parties regarding Adverse
Drug Experiences relating to Licensed Products; provided, that,
the Parties hereby acknowledge and agree that the failure of the Parties to
negotiate such agreement foregoing shall in no way limit or otherwise affect
the Parties’ respective obligations to provide the other Party with any and all
Adverse Drug Experiences in its Control relating to Licensed Products or other
MAY Compound-conjugated products as is reasonably necessary to ensure the safe
use of MAY Compound-conjugated products by the Parties.

 

(d)                                  Review of Correspondence for Licensed Products.  Biogen
Idec shall use reasonable commercial efforts to provide ImmunoGen with at least
[***] ([***])
days advance notice of any material meeting with the FDA which is for the
purpose of obtaining Regulatory Approval for any Licensed Product and Biogen
Idec shall provide to ImmunoGen the minutes of any such meeting communicated to
or from the Regulatory Authority within [***] ([***]) days from the date on which the meeting minutes were
submitted to, or received from such Regulatory Agency.

 

(e)                                   Confidential Information.  All
information, reports, updates, Adverse Drug Experience, product complaint and
other information provided by the disclosing Party to the receiving Party under
this Agreement (including under this Section 3.3), shall be considered
Confidential Information of the disclosing Party, subject to the terms,
exceptions and permitted disclosures of Section 6.

 

3.4                               Collaboration Committee.

 

(a)                                   Mandate and Establishment of Committee.  Promptly
after the Effective Date, the Parties shall form a Collaboration Committee to
serve as a forum for coordination and communication between the Parties with
respect to the Research Program and/or the Development of manufacturing
processes applicable to any MAY Compound or Licensed Product covered by this
Agreement (including, without limitation, all process science and process
development work, formulation work, and quality control/assurance work
hereunder), and to assist Biogen Idec in the exercise of its rights to make or
have made Licensed Products

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

24

 

under this Agreement.  The Collaboration Committee shall solely serve
as a forum for coordination and communication and shall not have any authority
to make decisions.  Within a reasonable
period of time after the Effective Date, the Parties shall each nominate
representatives (which shall be no less than two (2) and no more than five (5)
each) for membership on the Collaboration Committee.  Each representative shall be an individual of
suitable authority and seniority who has sufficient experience in
biopharmaceutical drug research, development, manufacturing or commercialization.  Each Party may change its representative(s)
as it deems appropriate by notice to the other Party.

 

(b)                                  Chair of Committee; Meetings.  The
chair of the Collaboration Committee shall be one of the Biogen Idec
representatives on the Collaboration Committee, as designated by Biogen
Idec.  The Collaboration Committee shall
meet on a semi-annual basis or other schedule agreed upon by the Parties,
unless at least thirty (30) days in advance of any meeting the chair of the
Collaboration Committee determines that there is no need for a meeting.  In such instance, the next Collaboration
Committee meeting shall also be scheduled as agreed upon by the Parties.  The location of meetings of the Collaboration
Committee shall alternate between ImmunoGen’s offices in the United States and
Biogen Idec’s offices in the United States, unless otherwise agreed by the
Parties. As agreed upon by the Parties, Collaboration Committee meetings may be
face-to-face or may be conducted through teleconferences and/or videoconferences.  In addition to its Collaboration Committee
representatives, each Party shall be entitled to have other employees attend
such meetings to present and participate. 
Each Party shall bear all costs and expenses, including travel and
lodging expense, that may be incurred by its Collaboration Committee
representatives or other of its attendees at Collaboration Committee meetings,
as a result of such meetings hereunder. 
Minutes of each Collaboration Committee meeting will be transcribed and
issued to members of the Collaboration Committee by the chair within thirty
(30) days after each meeting, and such minutes shall be reviewed and modified
as mutually required to obtain approval of such minutes promptly thereafter.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

25

 

4.                                      SUPPLY AND MANUFACTURING OBLIGATIONS

 

4.1                               Supply of Preclinical Materials, Clinical
Materials and Licensed Product. 
Biogen Idec shall be responsible, at its sole cost, for manufacturing or
having manufactured any materials (including without limitation, the [***] Antibody, the MAY Compound and the [***]  [***]-MAY
Conjugate) as may be required for all preclinical and clinical studies
necessary to obtain Regulatory Approval of Licensed Products and any materials
and/or quantities of each Licensed Product as may required for all preclinical
and clinical studies applicable to such Licensed Product and for
Commercialization of such Licensed Product.

 

4.2                               Supply
of Preclinical Materials by ImmunoGen. 
Notwithstanding anything to the contrary in Section 4.1, during the
Term of this Agreement, ImmunoGen shall, at Biogen Idec’s request, use
reasonable commercial efforts to supply Biogen Idec with such quantities of
Preclinical Materials as may be reasonably ordered by Biogen Idec in connection
with the conduct of pre-clinical Development activities (including, without
limitation, toxicology testing) relating to Licensed Products.  Biogen Idec shall order all amounts of
Preclinical Materials, and ImmunoGen shall deliver all such ordered amounts, in
accordance with advance ordering timeframes and delivery timeframes, and in
accordance with specifications, to be agreed upon by the Parties.  To the extent Biogen Idec requests ImmunoGen
to manufacture any [***]-MAY
Conjugate, Biogen Idec shall supply ImmunoGen with quantities of [***] Antibody sufficient to enable ImmunoGen to produce
such [***]-MAY Conjugate.  ImmunoGen shall use commercially reasonable
efforts to deliver such amounts of Preclinical Materials ordered in accordance
with the foregoing (including such agreed upon timeframes) in a timely manner; provided,
that, to the extent such Preclinical Materials are [***]-MAY
Conjugates, ImmunoGen’s obligations shall be contingent on the Parties’ mutual
agreement as to specifications and ImmunoGen’s receipt of the required
quantities of [***] Antibody from Biogen
Idec.  In connection with any ordering of
Preclinical Materials by Biogen Idec, ImmunoGen shall provide Biogen Idec
promptly with ImmunoGen’s good faith estimate of the Cost for manufacture and
supply of such Preclinical Materials. 
ImmunoGen’s price to supply Preclinical Materials to Biogen Idec shall
equal [******************]  ([***]) for such Preclinical
Materials.  In connection with such
supply, Biogen Idec hereby agrees that (a) it shall

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

26

 

not use the Preclinical Materials in any human
subject, (b) it shall use the Preclinical Materials in compliance with all
applicable federal, state and local laws and regulations, and (c) it (as a
matter of contract between itself and ImmunoGen) shall assume all liability for
damages that may arise from the use, storage and disposal of any Preclinical
Materials, unless such liability results from the negligence or willful
misconduct of ImmunoGen or its Affiliates or their respective employees or
agents.  Biogen Idec shall be entitled to
transfer Preclinical Materials to any Third Party under terms obligating such
Third Party not to transfer or use such Preclinical Materials except in
compliance with the foregoing clauses (a) and (b) of this Section 4.2.

 

4.3                               Supply
of Clinical Materials by ImmunoGen.  Notwithstanding anything
to the contrary in Section 4.1, during the Term of this Agreement,
ImmunoGen shall, at Biogen Idec’s request, use reasonable commercial efforts to
supply Biogen Idec with such quantities of Clinical Materials as may be
reasonably ordered by Biogen Idec in connection with human clinical testing of
such Clinical Materials through the completion of any Phase II Clinical Trials
deemed necessary by Biogen Idec.  Should
Biogen Idec determine in good faith that it plans to request ImmunoGen to
manufacture Clinical Materials as provided in the foregoing sentence, ImmunoGen
and Biogen Idec shall enter into a separate agreement detailing the terms of supply
for any Clinical Materials that ImmunoGen may be so requested to supply to
Biogen Idec for the purpose of conducting clinical trials, which supply
agreement shall include, without limitation, the terms set forth on Schedule
B attached hereto and the remainder of this Section 4.3 (the “Supply
Agreement”).  The Supply Agreement will
provide that Biogen Idec shall (a) provide ImmunoGen with a non-binding
forecast of the quantity of Clinical Materials it reasonably expects to order
over the succeeding [***] ([***]) month period and (b) supply ImmunoGen with quantities
of bulk [***] Antibody sufficient to enable
ImmunoGen to produce the quantity of Clinical Materials so requested.  Subject to the foregoing, Biogen Idec shall
order all amounts of Clinical Materials, and ImmunoGen shall deliver all such
ordered amounts, in accordance with forecasting parameters, advance ordering
timeframes and delivery timeframes to be agreed upon by the Parties in the
Supply Agreement.  The Supply Agreement
further shall provide that ImmunoGen shall use commercially reasonable efforts
to deliver such amounts of Clinical Materials ordered in accordance with the
foregoing (including such agreed upon timeframes) in a timely manner; provided,
that, ImmunoGen’s obligations shall be contingent on ImmunoGen’s

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

27

 

receipt of the required quantities of [***] Antibody from Biogen Idec.  In connection with any ordering of Clinical
Materials by Biogen Idec, ImmunoGen shall provide Biogen Idec promptly with
ImmunoGen’s good faith estimate of the Cost for manufacture and supply of such
Clinical Materials.  The Supply Agreement
shall provide that ImmunoGen’s price to supply Clinical Materials to Biogen
Idec shall equal [******************] ([***])  [***] for such
Clinical Materials.  Biogen Idec hereby
agrees that (a) it shall use the Clinical Materials in compliance with all
applicable federal, state and local laws, and (b) it (as a matter of contract
between itself and ImmunoGen) shall assume all liability for damages that may
arise from the use, storage and disposal of such Clinical Materials, unless
such liability results from the gross negligence or willful misconduct of
ImmunoGen or its Affiliates or their respective employees or agents.  Biogen Idec shall be entitled to transfer
Clinical Materials to any Third Party under terms obligating such Third Party
not to transfer or use such Clinical Materials except in compliance with the
foregoing clauses (a) and (b) of this Section 4.3 and the Supply Agreement.

 

4.4                               Purchase
of Dedicated Equipment.

 

(a)                                   If,
during the Term of this Agreement, ImmunoGen determines in good faith that it
is necessary or advisable to purchase Dedicated Equipment in order to perform
any of its obligations to manufacture Preclinical Materials and Clinical
Materials under Sections 4.2 or 4.3 of this Agreement, then ImmunoGen shall
provide Biogen Idec with written notice of such determination, along with the
estimated price for such purchase and quality parameters for the Dedicated
Equipment, for Biogen Idec’s written approval of such purchase and the price
and features of such Dedicated Equipment. 
Promptly after the consummation of such purchase, ImmunoGen shall
provide Biogen Idec with a copy of the invoice or invoices reflecting such
purchase, and, provided that Biogen Idec has provided ImmunoGen with prior
written approval of the purchase, Biogen Idec shall reimburse ImmunoGen for the
purchase of all such approved equipment hereunder within thirty (30) days of
its receipt of such invoice from ImmunoGen; provided, however,
that no costs reimbursed by Biogen Idec hereunder (or depreciation of such
purchased equipment or instruments) shall be included within the calculation of
any Costs under this Agreement.

 

(b)                                  Title
to the Dedicated Equipment shall at all times remain with Biogen Idec.  The Dedicated Equipment shall be and remain
the personal property of Biogen Idec.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

28

 

ImmunoGen shall cause the Dedicated Equipment to be
marked with the name of Biogen Idec as owner and shall execute such documents
and take such actions as Biogen Idec may from time to time reasonably deem
necessary to maintain or protect Biogen Idec’s ownership interest in the
Dedicated Equipment.  ImmunoGen shall not
change the location of the Dedicated Equipment without the prior written
consent of Biogen Idec and agrees to maintain the Dedicated Equipment free and
clear of any liens and encumbrances.

 

(c)                                   ImmunoGen
shall use the Dedicated Equipment solely to perform any of its obligations to
manufacture Preclinical Materials and Clinical Materials under Sections 4.2 or
4.3 of this Agreement.  ImmunoGen shall
use the Dedicated Equipment in a manner consistent with its intended
purposes.  ImmunoGen shall, [*******], cause the Dedicated Equipment to be kept and
maintained as recommended by the manufacturer in as good an operating condition
as when installed, ordinary wear and tear resulting from proper use excepted,
and ImmunoGen will, at Biogen Idec’s expense, provide all service, repair and
replacements necessary for such purpose.

 

(d)                                  Upon
Biogen Idec’s request and/or upon termination or expiration of the
manufacturing and supply obligations of ImmunoGen under this Agreement,
ImmunoGen shall deliver the Dedicated Equipment to Biogen Idec (or a Third
Party designated by Biogen Idec) within a reasonable period of time after
Biogen Idec’s request and/or termination or expiration of ImmunoGen’s
manufacturing and supply obligations at Biogen Idec’s sole expense.

 

(e)                                   BIOGEN
IDEC EXPRESSLY DISCLAIMS AND MAKES TO IMMUNOGEN NO WARRANTY OR REPRESENTATION,
EXPRESS OR IMPLIED, OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OR
AGAINST LATENT DEFECTS OR OTHERWISE WITH RESPECT TO THE DEDICATED EQUIPMENT.  All assignable warranties made by the
manufacturer or supplier relating to the Dedicated Equipment are hereby
assigned to ImmunoGen so long as ImmunoGen (or one of its Affiliates is in
possession of the Dedicated Equipment and ImmunoGen agrees to resolve any
claims directly with the manufacturer or supplier.  BIOGEN IDEC IS NOT RESPONSIBLE OR LIABLE FOR
ANY DIRECT, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOSSES OF
IMMUNOGEN OR ANY THIRD PARTY RESULTING FROM

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

29

 

THE INSTALLATION, OPERATION OR USE BY IMMUNOGEN OF THE
DEDICATED EQUIPMENT.

 

5.                                      PAYMENTS AND ROYALTIES

 

5.1                               Milestone Payments for Licensed Products.

 

(a)                                   Upfront Fee.  In consideration of the grant of the license
described in Section 2.1 hereof, Biogen Idec hereby agrees to pay
ImmunoGen an upfront fee (the “Upfront Fee”) in the amount of $1,000,000
payable in immediately available funds within ten (10) business days of the
Effective Date.  The Upfront Fee shall be
[***] only to the extent provided in
Section 5.1(c) below.

 

(b)                                  Milestones.  In further consideration of the grant of the
license by ImmunoGen hereunder, and subject to the other terms of this
Agreement, Biogen Idec will make the following nonrefundable, noncreditable
payments to ImmunoGen within [***] ([***]) days after the first occurrence of each of the
milestones set forth below:

 

	
  Milestone

  	
   

  	
  Milestone Payment

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [******] for
  a [**********]

  	
   

  	
  $

  	
  [******]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [**********]
  of [***]

  	
   

  	
   

  	
   

  
	
  [**********]
  in [*****] for a [**********]

  	
   

  	
  $

  	
  [******]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [**********]
  of [*************]

  	
   

  	
   

  	
   

  
	
  for a [**********]

  	
   

  	
  $

  	
  [******]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [**********]
  or [********] for a [********]

  	
   

  	
  $

  	
  [******]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [**********]
  of [***] or [***]
  or other [********]

  	
   

  	
   

  	
   

  
	
  [*****] by
  the [***] for a [**********]

  	
   

  	
  $

  	
  [******]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [**********]
  of an [***] or other [***]

  	
   

  	
   

  	
   

  
	
  [********] by
  the [***] for a [**********]

  	
   

  	
  $

  	
  [******]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [**********]
  of a [**************] for a

  	
   

  	
   

  	
   

  
	
  [**********]
  in [***]

  	
   

  	
  $

  	
  [******]

  	
   

  

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

30

 

	
  [**********]
  of [**********]

  	
   

  	
   

  	
   

  
	
  [*************]

  	
   

  	
  $

  	
  [******]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [**********]
  of [**********]

  	
   

  	
   

  	
   

  
	
  [*************]

  	
   

  	
  $

  	
  [******]

  	
   

  

 

It is hereby acknowledged and agreed that any
milestone payment shall be made only once, with respect to the first
achievement of the relevant milestone regardless of how many times such
milestone is achieved and how many Licensed Products achieve such milestone
under this Agreement.  Biogen Idec shall
notify ImmunoGen of the achievement of each milestone hereunder as provided in
Section 3.3(b) above.

 

(c)                                   [*********] of [******].  In the event that an [*******************************************

*******], Biogen Idec shall give ImmunoGen written notice of same
and Biogen Idec shall be entitled to [***] a [***] of the [***] pursuant
to Section [***] above towards the [***] included in any [***] that may
be [***] by the Parties in accordance with
Section 2.4 which covers a [***] of an [***] by Biogen Idec and a [***],
as follows:

 

	
  [******] of [***] of [****]

  [******] Under Section [***]

  	
   

  	
  [*********] of [*********]

  That Can Be [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  From [******] to
  [***], [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  From [***], [***] to , [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  From [***], [***] to [***], [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  From [***], [***] to [***], [***]

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  On and after [***], [***] and [***]

  	
   

  	
  [***]

  	
   

  

 

Notwithstanding
the above, the Parties hereby acknowledge and agree that ImmunoGen shall be
under no obligation to [***] into any [************]
with Biogen Idec.

 

5.2                               Research Funding.  In consideration of the performance by
ImmunoGen of the Research Program, Biogen Idec will pay ImmunoGen for all FTEs
used by ImmunoGen in such Research Program, as described in the Research Plan
and/or agreed to by the Parties, at a rate per FTE equal to the FTE Rate.  From time to time after the Effective Date, the
Parties shall agree in writing upon the number of FTEs required of ImmunoGen
for agreed-upon portions of the Research Program and Biogen Idec shall pay the
FTE Cost for the FTEs who perform the

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

31

 

approved activities but [***]
to [***] the [***]
of [***] reflected in such written
agreement.  If, at any time during the
Term of this Agreement, ImmunoGen determines that the actual number of FTEs for
a particular period agreed to by the Parties is [***]
to [***] the [***]
set forth in such written agreement for such period, ImmunoGen shall give
Biogen Idec prompt written notice of same and the Parties shall discuss in good
faith whether to [***] the [***]
of such [******]  [***]
or to [***] the [***]
to be [***], such that such [***] are [***].

 

5.3                               Payment of Royalties; Royalty Rates.

 

(a)                                   Royalty Payments.  In further consideration of the grant of the
license by ImmunoGen hereunder, and subject to the other terms of this
Agreement, commencing on the first date of First Commercial Sale of Licensed
Products in any country or jurisdiction in the Territory, Biogen Idec shall pay
to ImmunoGen the following royalties (subject to Sections 5.3(b) and 5.5),
based on Net Sales of all Licensed Products sold by Biogen Idec, its Affiliates
and/or Sublicensees, on an incremental basis in each calendar year during the
royalty term specified in Section 5.5, at the following rates:

 

	
  For Annual Worldwide Net Sales

  of Licensed Products

  	
   

  	
  Royalty
  Rate (% of Annual Net Sales)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Above $[***] and up to $[******]

  	
   

  	
  [***]

  	
  %

  
	
   

  	
   

  	
   

  	
   

  
	
  Above $[******]
  and up to $[******]

  	
   

  	
  [***]

  	
  %

  
	
   

  	
   

  	
   

  	
   

  
	
  Above $[******]

  	
   

  	
  [***]

  	
  %

  

 

(b)                                  Third Party Royalty Offset.  In the event that Biogen Idec determines
that, in order to Develop, have Developed, Commercialize, have
Commercialized, make, have made, use, have used, sell, have sold, offer for
sale, import, have imported, export or have exported Licensed Products in any
country in the Territory, it must make and actually does make royalty payments
to any Third Party (“Third Party
Payments”) (a) pursuant to a license to an issued patent or patents or
patent applications, in the absence of which the MAY Compound portion of a
Licensed Product could not or, in the case of patent applications, if a patent
or patents issued from such an application, would not be able to be developed,
manufactured or sold in such country and/or (b) pursuant to a license to an
issued patent or patents specific to the Licensed Technology, in the absence of
which any of the Licensed Technology reasonably necessary to conjugate MAY
Compound to an [***] Antibody as part of Licensed
Product could

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

32

 

not or, in the case of patent applications, if a
patent or patents issued from such an application, would not be able to be
practiced, then the royalties due to ImmunoGen for such Licensed Product may be
reduced by [***] percent ([***]%) of the amount of such Third Party Payments in such
country.  Notwithstanding the foregoing,
in the event that any license referred to in (a) or (b) above is to a patent
application or applications that do not result in an issued patent on or before
[***] ([***])
years from the date of filing (calculated from the latest date of filing in the
case of a license involving multiple patent applications), then (1) any
adjustment to the royalties relating to such license under this Section 5.3(b)
shall be immediately suspended unless and until such time as a patent is issued
and (2) except with respect to licenses to a patent application or applications
from a Third Party or its Affiliates excepted from the representation made by
ImmunoGen under Section 9.1(i), Biogen Idec shall as promptly as possible make
a one-time payment to ImmunoGen in an amount equal to the difference between the
adjusted royalty that was paid by Biogen Idec as a result of such patent
application license and the amount of the royalty that would have been paid to
ImmunoGen if no such adjustment had been made. 
In no event shall the reductions under this Section 5.3 and the
reductions under Sections 5.5 and 7.5 reduce the royalty for any Licensed
Product payable under Section 5.3(a) to less than [***]
percent ([***]%) of Net Sales in any
country.  Furthermore, in the event Biogen Idec determines that it
is necessary or useful for the Development or Commercialization of Licensed
Products to obtain a license to Technology or Patent Rights owned or controlled
by a Third Party, ImmunoGen agrees to take reasonable action to assist
Biogen Idec in obtaining such a license upon request by Biogen Idec and at
Biogen Idec’s sole expense but without [*********] to Biogen Idec (other than
such expense) or such Third Party. Such action by ImmunoGen may include
providing reasonable assistance to Biogen Idec to the extent it seeks to
execute, or have executed by ImmunoGen, any documents that may be reasonably
necessary to remove contractual impediments placed on such Third Party by
ImmunoGen restricting such Third Party from granting such a license to Biogen
Idec.

 

5.4                               One
Royalty.  Only one royalty,
calculated in accordance with this Section 5, shall be payable to ImmunoGen
hereunder for each sale of a Licensed Product.

 

5.5                               Royalty
Term; Royalty Rate for Net Sales for Licensed Products not covered by a Valid
Claim of the Licensed Patent Rights. 
Biogen Idec shall pay royalties with respect

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

33

 

to each Licensed Product on a country-by-country and
Licensed Product-by-Licensed Product basis until the later of (a) [***] ([***]) years
from the First Commercial Sale of such Licensed Product in such country and (b)
the expiration of the last to expire Valid Claim of the Licensed Patent Rights
which, but for the license granted to Biogen Idec herein, would be infringed by
the manufacture, use, sale, offer for sale, or importation of the Licensed
Product in such country (the “Royalty Term”).  Following such Royalty Term, Biogen Idec shall
have a fully paid-up, irrevocable, freely transferable and sublicensable
license in such country under the relevant Licensed Patent Rights and Licensed
Technology, to Develop, have Developed, Commercialize, have Commercialized,
make, have made, use, have used, sell, have sold, offer for sale, import, have
imported, export and have exported such Licensed Product in such country.  Notwithstanding the foregoing, if, during the
Royalty Term, the use or sale of a Licensed Product by Biogen Idec, its
Affiliates or Sublicensees in a country in which the Licensed Product is sold
is not covered by a Valid Claim of the Licensed
Patent Rights covering the
Licensed Product in such country, the royalties payable with respect to Net
Sales in such country shall be reduced by [***] percent ([***]%) of the amounts otherwise due under Section 5.3(a).

 

5.6                               Payment Terms.

 

(a)                                   Payment
of Milestones; Payment of Royalties. 
Biogen Idec shall make any milestone payments owed to ImmunoGen
hereunder in United States Dollars, using the wire transfer provisions of
Section 5.6(d) within [***] ([***]) days after the occurrence of the applicable milestone.  Biogen Idec shall make any royalty payments
owed to ImmunoGen in United States Dollars, quarterly within [***] ([***]) days
following the end of each calendar quarter for which sales giving rise to such
royalties are deemed to occur (as provided in the next sentence), using the
wire transfer provisions of Section 5.6(d).  For purposes of determining when a sale of
any Licensed Product occurs under this Agreement, the sale shall be deemed to
occur on the earlier of (i) the date the Licensed Product is received by the
third party purchaser or (ii) the date of the invoice to the purchaser of the
Licensed Product.  Each royalty payment
shall be accompanied by a report for each country in the Territory in which sales
of Licensed Products occurred in the calendar quarter covered by such statement
in substantially the form attached hereto as Schedule D.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

34

 

(b)                                  Accounting.  All payments hereunder shall be made in the
United States in United States dollars. Conversion of foreign currency to
United States dollars shall be made at the conversion rate existing in the
United States (as reported in The
Wall Street Journal) on the last
business day of the applicable calendar quarter to which payment relates.  If The
Wall Street Journal ceases to be
published, then the rate of exchange to be used shall be that reported in such
other business publication of national circulation in the United States as the
Parties reasonably agree.

 

(c)                                   Tax
Withholding; Restrictions on Payment.  All payments
hereunder shall be made free and clear of any taxes, duties, levies, fees or
charges, except for withholding taxes (to the extent applicable).  Biogen Idec shall make any applicable
withholding payments due on behalf of ImmunoGen and shall promptly provide
ImmunoGen with written documentation of any such payment sufficient to satisfy
the requirements of the United States Internal Revenue Service relating to an
application by ImmunoGen for a foreign tax credit for such payment.  If by law, regulations or fiscal policy of a
particular country in the Territory, remittance of royalties in United States
Dollars is restricted or forbidden, written notice thereof shall promptly be
given to ImmunoGen, and payment of the royalty shall be made by the deposit
thereof in local currency to the credit of ImmunoGen in a recognized banking
institution designated by ImmunoGen by written notice to Biogen Idec.  When in any country in the Territory the law
or regulations prohibit both the transmittal and the deposit of royalties on
sales in such country, royalty payments shall be suspended for as long a such
prohibition is in effect and as soon as such prohibition ceases to be in
effect, all royalties that Biogen Idec would have been under an obligation to
transmit or deposit but for the prohibition shall forthwith be deposited or
transmitted, to the extent allowable.

 

(d)                                  Wire
Transfers.  All payments hereunder
shall be made to ImmunoGen by bank wire transfer in immediately available funds
to the account designated by ImmunoGen by written notice to Biogen Idec from
time to time.

 

5.7                               Overdue
Payments.  Subject to the other
terms of this Agreement, royalties or milestones not paid within the time
period set forth in this Section 5 shall bear interest at a rate of [***] percent ([***]%) plus
three-month LIBOR (London Interbank Offering Rate) from the delinquency date until paid in full, provided that in
no event shall such annual rate exceed the

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

35

 

maximum interest rate permitted by law in regard to
such payments.  Such royalty or milestone
payment when made shall be accompanied by all interest so accrued.  Such interest and the payment and acceptance
thereof shall not negate or waive the right of ImmunoGen to any other remedy,
legal or equitable, to which it may be entitled because of the delinquency of
the payment.

 

5.8                               Records Retention; Audit.

 

(a)                                   Royalties.  Commencing as of the date of First Commercial
Sale of the first Licensed Product, Biogen Idec and its Affiliates and
Sublicensees shall keep for at least [***] ([***]) years from the end of the calendar year to which they
pertain complete and accurate records of sales by Biogen Idec or its Affiliates
or Sublicensees, as the case may be, of each Licensed Product, in sufficient
detail to allow the accuracy of the royalties to be confirmed.

 

(b)                                  Audit.  Subject to the other terms of this
Section 5.8(b), at the request of ImmunoGen, upon at least [***] ([***]) business
days’ prior written notice, and at its sole expense (except as otherwise
provided herein), Biogen Idec shall permit an independent certified public
accountant reasonably selected by ImmunoGen and reasonably acceptable to Biogen
Idec to inspect (during regular business hours) the relevant records required
to be maintained by Biogen Idec under Section 5.8(a).  At ImmunoGen’s request (which shall not be
made more frequently than once per calendar year), the accountant shall be
entitled to audit the then-preceding [***] ([***]) years of Biogen Idec’s records for purposes of
verifying Biogen Idec’s royalty calculations; provided, that no year shall be
audited more than once.  At Biogen Idec’s
request, the accountant shall enter into a confidentiality agreement with both
Parties substantially similar to the provisions of Section 6 limiting the
disclosure and use of such information by such accountant to authorized
representatives of the Parties and the purposes germane to this
Section 5.8.  Results of any such
audit shall be made available to both Parties and shall be binding on both
Parties.  ImmunoGen agrees to treat the
results of any such accountant’s review of Biogen Idec’s records under this
Section 5.8 as Confidential Information of Biogen Idec subject to the
terms of Section 6.  If any such
audit reveals a deficiency in the calculation of royalties resulting from any
underpayment by Biogen Idec, Biogen Idec shall promptly pay ImmunoGen the amount
remaining to be paid (plus interest thereon at the rate provided in
Section 5.7 above), and if such underpayment is by [***]
percent ([***]%) or more, Biogen Idec

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

36

 

shall pay the costs and expenses of the audit.  If such audit reveals overpayments by Biogen
Idec in any year, such amounts shall be refunded by ImmunoGen to Biogen Idec.

 

6.                                      TREATMENT OF CONFIDENTIAL INFORMATION

 

6.1                               Confidential
Information.  ImmunoGen and Biogen Idec each recognize that
the other Party’s Confidential Information constitutes highly valuable and
proprietary confidential information. 
For a period of [***] ([***]) years after the receipt of any such Confidential
Information from the disclosing Party hereunder, subject to the terms of this
Section 6, the receiving Party shall keep confidential and not disclose
(by publication or otherwise) such Confidential Information of the disclosing
Party, and shall not use, publish or otherwise disclose Confidential
Information of the disclosing Party for any purpose other than those purposes
contemplated by this Agreement.  Each
receiving Party shall take such action, and shall cause its Affiliates or
Sublicensees to take such action, to preserve the confidentiality of the
disclosing Party’s Confidential Information as it would customarily take to
preserve the confidentiality of its own Confidential Information, using, in all
such circumstances, not less than reasonable care. Each receiving Party, upon
the request of the disclosing Party, will return all the Confidential
Information disclosed or transferred to it by the disclosing Party pursuant to
this Agreement other than Confidential Information that was included in a
filing with a Regulatory Authority, including all copies and extracts of documents
and all manifestations in whatever form, within [***]
([***]) days of the termination or
expiration of this Agreement; provided  however, that a receiving
Party may retain (a) any Confidential Information of the disclosing Party
relating to any license which expressly survives termination and (b) one (1)
copy of all other Confidential Information in inactive archives solely for the
purpose of establishing the contents thereof.

 

6.2                               Permitted Disclosures; Publications.

 

(a)                                   Disclosures
to Certain Employees, Agents and Third Parties.  Each receiving Party shall be entitled to
disclose Confidential Information of the disclosing Party to employees of the
receiving Party, provided that such employees are bound by obligations of
confidentiality to the receiving Party, and also to Affiliates, Sublicensees,
potential Sublicensees, consultants, agents, Third Parties (other than
Regulatory Authorities) for any purpose provided for in this Agreement,
provided that any such Affiliate, Sublicensee, potential Sublicensee,

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

37

 

consultant, agent or other Third Party (other than
Regulatory Authorities) has first agreed to confidentiality restrictions and
obligations at least as protective as this Section 6, in each case for any
purpose contemplated by this Agreement (including without limitation
Development and Commercialization of Licensed Products and as reasonably
necessary for a Party to exercise any of its rights or perform any obligations
under this Agreement).

 

(b)                                  Disclosures
to Regulatory Authorities.  Biogen
Idec shall be entitled to disclose Confidential Information of ImmunoGen to
Regulatory Authorities in connection with Licensed Products free of any
obligation to obtain agreement or an understanding from any Regulatory
Authority that it will maintain the confidentiality of such Confidential
Information.

 

(c)                                   Other
Permitted Disclosures. 
Notwithstanding the foregoing, Confidential Information of a disclosing
Party may be disclosed by the receiving Party to the extent such disclosure is
reasonably necessary for (i) filing or prosecuting patent applications or
maintaining patents, (ii) prosecuting or defending litigation, enforcing rights
and/or obligations under this Agreement, or (iii) complying with applicable laws,
regulations or court order; provided, that, if a receiving Party
is required by applicable law, regulation or court order to make such
disclosure of the disclosing Party’s Confidential Information, it will give
reasonable advance notice of the need for such disclosure and will use its
commercially reasonable efforts to secure confidential treatment (if available)
of such disclosing Party’s Confidential Information required to be disclosed.

 

(d)                                  Review
of Publications.  Each receiving
Party shall consult with the disclosing Party prior to the submission of any
manuscript for publication if the publication will contain any Confidential
Information of the disclosing Party, unless applicable laws and regulations
prohibit such consultation.  Such
consultation shall include providing a copy of the proposed manuscript to the
disclosing Party at least [***] ([***]) days prior to the proposed date of submission to a
publisher, incorporating appropriate changes proposed by the disclosing Party
regarding its Confidential Information into the manuscript submission and
deleting all Confidential Information of the disclosing Party as it may
request; provided, however, that the disclosing Party’s
review hereunder shall be deemed completed at the end of such [***] ([***])-day
period. Notwithstanding the foregoing, ImmunoGen shall not present or publish
results of

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application requesting
confidential investment under Rule 24b-2 under the Securities Exchange Act of
1934.

 

38

 

any research or other activities under this Agreement
related to Licensed Products (including under the Research Program) without the
prior written consent of Biogen Idec.

 

6.3                               Use of Names; Press Releases.

 

(a)                                   Use
of Names.  A Party may not use the
name of the other Party (or any trademarks or trade names of the other Party)
in any publicity or advertising without the prior written consent of the other
Party.

 

(b)                                  Press
Releases.  Neither Party may issue a
press release or otherwise publicize or disclose the terms or conditions of
this Agreement or its activities under this Agreement, without the prior
written consent of the other Party; provided, however, that (i)
either Party may make such a disclosure to the extent required by law or by the
requirements of any nationally recognized securities exchange, quotation system
or over-the-counter market on which such Party has its securities listed or
traded, (ii) either Party may make such a disclosure to any investors,
prospective investors, lenders and other potential financing sources who are
obligated to keep such information confidential, and (iii) Biogen Idec may make
disclosures about its Development and Commercialization of Licensed Products
under this Agreement without the prior written consent of ImmunoGen; provided,
that, if any such disclosure includes a description of any Technology
and/or Patent Rights Controlled by ImmunoGen, Biogen Idec shall confirm the
accuracy of such information with ImmunoGen prior to releasing such disclosure
and if any such disclosure includes patentable subject matter not covered by
the Licensed Patent Rights, Biogen Idec shall obtain the prior written consent
of ImmunoGen to such disclosure.  In the event of any disclosure under (i) or
(ii), the disclosing Party shall make reasonable efforts to provide the other
Party with notice beforehand and to coordinate with the other Party with
respect to the wording and timing of any such disclosure which consent shall
not be unreasonably withheld.  The
Parties shall mutually agree on the text of any press release announcing the
execution of this Agreement.  Once any
written text is approved (as applicable) for disclosure by both Parties as
provided herein, either Party may make subsequent or repeated public
disclosures of the contents thereof without the further approval of the other
Party.

 

6.4                               Integration;
Survival.  As to the subject
matter of this Agreement, this Section 6 supersedes any confidential
disclosure agreements between the Parties, including, without limitation, the
confidentiality provisions of the MTA, and of that certain Confidentiality

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

39

 

Agreement effective [***],
[***]. 
Any confidential information of a Party under any such agreement shall
be treated as Confidential Information of such Party hereunder, subject to the
terms of this Section 6. 
Section 6 shall survive termination or expiration of this
Agreement.

 

7.                                      PROVISIONS CONCERNING THE FILING, PROSECUTION AND

MAINTENANCE
OF PATENT RIGHTS

 

7.1                               Ownership of Intellectual Property.

 

(a)                                   Solely-Owned
Technology.  Subject to the licenses
granted hereunder, ImmunoGen shall own (i) the Licensed Patent Rights, the
Licensed Technology, the ImmunoGen Materials, (ii) all ImmunoGen Program
Technology and (iii) all inventions (including, without limitation,
Improvements) conceived and reduced to practice solely by employees of or agents
or others obligated to assign inventions to ImmunoGen or an ImmunoGen Affiliate
(“ImmunoGen Inventions”).  Subject to the
licenses granted hereunder, Biogen Idec shall own (i) the Biogen Idec
Background Technology, the Biogen Idec Patent Rights and the Biogen Idec
Proprietary Materials, (ii) all Biogen Idec Program Technology and (iii) all
inventions (including, without limitation, Improvements) conceived and reduced
to practice solely by employees of or agents or others obligated to assign
inventions to Biogen Idec or a Biogen Idec Affiliate (“Biogen Idec Inventions”).  Subject to the licenses granted to Biogen
Idec under this Agreement, the Party solely owning any Technology hereunder
shall be the sole owner of any inventorship certificate(s), patent application(s)
and patent(s) thereon. All determinations of inventive contribution shall be as
determined by United States laws of inventorship.  Subject to the terms of Section 7.2
below relating to Improvements, the Party solely owning an invention hereunder will
be solely responsible, at its own cost and expense and in its sole discretion,
for the filing, prosecution and maintenance of any inventorship certificate(s),
patent application(s) and patent(s) thereon.

 

(b)                                  Joint
Technology.  Subject to the licenses
granted hereunder, all Joint Program Technology shall be jointly owned by
ImmunoGen and Biogen Idec.  All
determinations of inventive contribution shall be as determined by United
States laws of inventorship.  The Parties
shall also jointly own any inventorship certificate(s), patent application(s)
and patent(s) on any inventions related to Joint Program Technology and

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

40

 

Improvements jointly conceived and reduced to practice
hereunder by at least one employee of or agent or other person obligated to
assign inventions to ImmunoGen or an ImmunoGen Affiliate and by at least one
employee of or agent or other person obligated to assign inventions to Biogen
Idec or a Biogen Idec Affiliate (“Joint Inventions”).  The terms of Section 7.2 below relating
to Joint Program Technology shall apply to any inventorship certificate(s),
patent application(s) and patent(s) thereon.

 

(c)                                   Disclosure.  As regards any Program Technology hereunder,
each Party shall provide to the other Party any invention disclosure made
during the course of performance of this Agreement and relating to activities
carried out hereunder within [***] ([***]) days after such Party receives such disclosure from
its employees, agents or others obligated to assign inventions to such Party.

 

7.2                               Patent Filing, Prosecution and Maintenance.

 

(a)                                   ImmunoGen
Rights – Solely-Owned Technology.  Subject to the other terms of this
Section 7.2, ImmunoGen shall have the right to prepare, file, prosecute,
obtain and maintain, at its sole cost and expense, all Licensed Patent Rights
including all Patent Rights covering ImmunoGen Program Technology and ImmunoGen
Inventions.  ImmunoGen will keep Biogen
Idec reasonably informed of the status of each such filing covering Licensed
Patent Rights and Patent Rights covering ImmunoGen Program Technology and
ImmunoGen Inventions that are Improvements licensed to Biogen Idec under
Section 2.3, and the prosecution and maintenance thereof, including, without
limitation, by using reasonable commercial efforts to (i) provide Biogen Idec
with a copy of any such proposed patent application covering ImmunoGen Program
Technology and/or ImmunoGen Inventions that are Improvements licensed to Biogen
Idec under Section 2.3 for review and comment reasonably in advance of filing,
and (ii) provide Biogen Idec a reasonable time prior to taking or failing to
take any action that would affect the scope or validity of any such of any such
filing (including the substantially narrowing, cancellation or abandonment of
any claim(s), or the failure to file or perfect the filing of any claim(s) in
any country), with prior written notice of such proposed action or inaction and
supporting documentation, including without limitation, relevant portions of
the underlying prosecution file history so that Biogen Idec has a reasonable
opportunity to review and comment.  If
ImmunoGen fails to undertake the filing(s) of any patent application with
respect to any

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

41

 

invention under such Licensed Patent Rights or such
Patent Rights covering such ImmunoGen Program Technology or ImmunoGen
Improvements within [***] ([***]) days after receipt of written notice from Biogen Idec
that Biogen Idec believes filing of such an application by ImmunoGen is
appropriate, Biogen Idec may undertake such filing(s) at its own expense.

 

(b)                                  Biogen
Idec Rights.  Biogen Idec shall have
the right to prepare, file, prosecute, obtain and maintain, at its sole cost
and expense, all Patent Rights covering Biogen Idec Background Technology,
Biogen Idec Program Technology and Biogen Idec Inventions.  Biogen Idec will keep ImmunoGen reasonably
informed of the status of each such filing covering Biogen Idec Inventions that
are Improvements licensed to ImmunoGen under Section 2.3, and the prosecution
and maintenance thereof, including, without limitation, by using reasonable
commercial efforts to (i) provide ImmunoGen with a copy of any such proposed
patent application covering Biogen Idec Program Technology and/or Biogen Idec
Inventions that are Improvements licensed to ImmunoGen under Section 2.3 for
review and comment reasonably in advance of filing, and (ii) provide ImmunoGen
a reasonable time prior to taking or failing to take any action that would
affect the scope or validity of any such of any such filing (including the
substantially narrowing, cancellation or abandonment of any claim(s) or the
failure to file or perfect the filing of any claim(s) in any country), with
prior written notice of such proposed action or inaction and supporting
documentation, including without limitation, relevant portions of the
underlying prosecution file history so that ImmunoGen has a reasonable
opportunity to review and comment.  If
Biogen Idec fails to undertake the filing(s) of any patent application with
respect to any invention under such Biogen Idec Improvement within [***] ([***]) days
after receipt of written notice from ImmunoGen that ImmunoGen believes filing
of such an application by Biogen Idec is appropriate, ImmunoGen may undertake
such filing(s) at its own expense.

 

(c)                                   Joint
Program Technology.  As regards any
Patent Rights claiming Joint Program Technology and Joint Inventions, the Party
from whom the majority of the data underlying any such Joint Program Technology
or Joint Inventions arose (the “controlling Party”) will have the first right,
but not the obligation, to undertake filing(s), prosecution and maintenance of
inventorship certificate(s), patent application(s) and patent(s) thereon.  In connection with any such filing(s), the
controlling Party will use patent counsel mutually

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

42

 

acceptable to each Party (in its reasonable
determination) and the Parties will, prior to filing of the patent application,
agree on mutually acceptable sharing of the costs and expenses of such
filing(s), prosecution and maintenance. 
In any case the controlling Party (i) will provide the non-controlling
Party with a copy of any such proposed patent application for review and comment
reasonably in advance of filing, and (ii) will keep the non-controlling Party
reasonably informed of the status of such filing, prosecution and maintenance,
including, without limitation, by using reasonable commercial efforts to (A)
provide the non-controlling Party with copies of all communications received
from or filed in patent office(s) with respect to such filing, and (B) provide
the non-controlling Party, a reasonable time prior to taking or failing to take
any action that would affect the scope or validity of any such filing
(including the substantially narrowing, cancellation or abandonment of any
claim(s) without retaining the right to pursue such subject matter in a
separate application, or the failure to file or perfect the filing of any claim(s)
in any country), with prior written notice of such proposed action or inaction
so that the non-controlling Party has a reasonable opportunity to review and
comment. If the controlling Party fails to undertake the filing(s) of any such
patent application with respect to any such Joint Program Technology or Joint
Inventions within [***] ([***]) days after receipt of written notice from the other
Party that the other Party believes filing(s) of such an application by such
Party is appropriate, such other Party may undertake such filing(s) at its own
expense, in which case the non-filing Party will assign all of its rights to
such Joint Program Technology or Joint Inventions to the filing Party and any
subsequently issued patent thereon will be owned solely by the filing
Party.  Subject to the licenses granted
under this Agreement, either Party may assign its rights hereunder to any Joint
Program Technology or Joint Inventions, inventorship certificate, patent
application or patent to the other Party, who will then have the right, in its
discretion, to assume the filing, prosecution and/or maintenance thereof as the
sole owner thereof and at its sole cost and expense.

 

7.3                               Notice
of Infringement.  If, during the
Term of this Agreement, either Party learns of any actual, alleged or
threatened infringement by a Third Party of any Licensed Patent Rights under
this Agreement, such Party shall promptly notify the other Party and shall
provide such other Party with available evidence of such infringement.

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

43

 

7.4                               Infringement of Patent Rights.

 

(a)                                   ImmunoGen
Rights to Control.  ImmunoGen shall
have the first right (but not the obligation), at its own expense, to bring and
control the suit (or take other appropriate legal action) against any actual,
alleged or threatened infringement of the Licensed Patent Rights including
Patent Rights covering ImmunoGen Improvements, with legal counsel of its own
choice.  Biogen Idec shall have the
right, at its own expense, to be represented in any such action by ImmunoGen by
counsel of Biogen Idec’s own choice; provided, however, that
under no circumstances shall the foregoing affect the right of ImmunoGen to
bring and control the suit as described in the first sentence of this
Section 7.4(a).  If ImmunoGen does
not file any action or proceeding against such infringement within [*********] ([***]) days after the later of (i) ImmunoGen’s notice to
Biogen Idec under Section 7.3 above, (ii) Biogen Idec’s notice to
ImmunoGen under Section 7.3 above, or (iii) a written request from Biogen
Idec to take action with respect to such infringement, then Biogen Idec shall
have the right (but not the obligation), at its own expense, to bring suit (or
take other appropriate legal action) against such actual, alleged or threatened
infringement, with legal counsel of its own choice. ImmunoGen shall have the
right, at its own expense, to be represented in any such action by Biogen Idec
by counsel of ImmunoGen’s own choice. 
Any damages, monetary awards or other amounts recovered, whether by
judgment or settlement, pursuant to any suit, proceeding or other legal action
taken under this Section 7.4(a) attributable to the development,
manufacture, sale or importation of Licensed Products under this Agreement, shall
first be applied to reimburse the costs and expenses (including attorneys’
fees) of the Party bringing such suit or proceeding or taking such other legal
action, then to the costs and expenses (including attorneys’ fees), if any, of
the other Party and second, to Biogen Idec in reimbursement for lost sales
associated with Licensed Products and to ImmunoGen in reimbursement for lost
royalties owing hereunder based on such lost sales.  Any other damages, awards or amounts
recovered (including for punitive damages) shall be allocated as follows:  (A) if Biogen Idec is the Party bringing such
suit or proceeding or taking such other legal action, [***]
percent ([***]%) to Biogen Idec, and [***] percent ([***]%) to
ImmunoGen, (B) if ImmunoGen is the Party bringing such suit or proceeding or
taking such other legal action, [***] percent ([***]%) to ImmunoGen and (C) if the suit is brought jointly,
[***] percent ([***]%)
to each Party.  If a Party brings any
such action or proceeding hereunder, the other Party agrees to be joined as
party plaintiff if necessary to

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

44

 

prosecute such action or proceeding, and to give the
Party bringing such action or proceeding reasonable assistance and authority to
file and prosecute the suit; provided, however, that neither
Party shall be required to transfer any right, title or interest in or to any
property to the other Party or any Third Party to confer standing on a Party
hereunder.

 

(b)                                  Infringement
of Joint Program Technology.  As to
any actual, alleged or threatened infringement of any Patent Rights jointly
owned by ImmunoGen and Biogen Idec under this Agreement, including actions
against any alleged infringer, the Parties hereto will consult with each other
in good faith regarding the best manner in which to proceed.  The Parties agree as a basic principle that
in the case of such actions against infringers, the expenses incurred and
damages awarded shall be for the account of the Party or Parties who take such
actions to the extent of their financial participation therein.

 

(c)                                   Biogen
Idec Rights to Control.  Biogen Idec
shall have the sole right (but not the obligation), at its own expense, to
bring suit (or take other appropriate legal action) against any actual, alleged
or threatened misappropriation or infringement of the Biogen Idec Background
Technology and Biogen Idec Improvements, with legal counsel of its own choice.

 

7.5                               Third
Party Patents.  If any Third
Party claims that a patent it owns or controls claims any aspect of a Licensed
Product or its manufacture, use, sale, offer for sale, or importation, the
Party with notice of such claim shall notify the other Party promptly. In such
circumstances, Biogen Idec shall have the sole right (but not the obligation),
at its own expense, to defend or bring suit (or take other appropriate legal
action) using legal counsel of its own choice. 
ImmunoGen shall have the right, at its own expense, to be represented in
any such action by Biogen Idec by counsel of ImmunoGen’s own choice; provided,
however, that under no circumstances shall the foregoing affect the
right of Biogen Idec to control the suit as described in the first sentence of
Section 7.4(c).  Biogen Idec shall have the sole control and authority
over how to respond to and defend against such Third Party claims and whether
and how to bring any counterclaims and will keep ImmunoGen reasonably informed
of the status of the claims.  In the
event that pursuant to any suit, proceeding or other legal action taken under
this Section 7.5, a court of competent jurisdiction orders the payment of
any damages, monetary awards or other amounts by Biogen Idec to such Third
Party and such court determines that all or a portion of such damages, monetary
award or other award is attributable to the development, manufacture,

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

45

 

sale or importation of the MAY Compound portion of a
Licensed Product, Biogen Idec shall be entitled to offset [***]
percent ([***]%) of the applicable portion of
such damages, monetary award or other amounts against any royalties then owed
or which become due thereafter under this Agreement to ImmunoGen.  Notwithstanding the foregoing, in no event
shall the reductions under Sections 5.3 and 5.5 and this Section 7.5 reduce the
royalty for any Licensed Product payable under Section 5.3(a) to less than [***] percent ([***]%) of Net
Sales in any country.  In the event
further manufacture, use, sale, offer for sale or importation of the Licensed
Product is enjoined as a result of a judgment in any suit, proceeding or other
legal action taken under this Section 7.5 the Parties shall cooperate with
each other reasonably and in good faith to comply with such judgment.

 

7.6                               Trademarks.  All Licensed Products shall be sold under one
or more trademarks and trade names selected and owned by Biogen Idec in the
Territory.  Biogen Idec shall control the
preparation, prosecution and maintenance of applications related to all such
trademarks and trade names in the Territory, at its sole cost and expense and
at its sole discretion.  ImmunoGen shall
notify Biogen Idec promptly upon learning of any actual, alleged or threatened
infringement of a trademark or trade name applicable to a Licensed Product in the
Territory, or of any unfair trade practices, trade dress imitation, passing off
of counterfeit goods, or like offenses in the Territory.  All of the costs, expenses and legal fees in
bringing, maintaining and prosecuting any action to maintain, protect or defend
any trademark owned by Biogen Idec hereunder, and any damages or other
recovery, shall be Biogen Idec’s sole responsibility, and taken in its sole
discretion.

 

7.7                               Integration.  This Section 7 supersedes any agreement
between the Parties as to the subject matter hereof, including, without
limitation, any provisions of the MTA relating to inventions, patent
applications and patents.

 

8.                                      TERM AND TERMINATION

 

8.1                               Term;
Expiration.  The term of this
Agreement (the “Term”) shall,
unless earlier terminated, expire on a country-by-country basis upon the
expiration of the final royalty payment obligation with respect to the final
Licensed Product under Section 5.3(a) above.  Upon the expiration of the Term of this
Agreement, Biogen Idec shall have a fully paid-up, irrevocable,

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

46

 

freely transferable and sublicensable license under
the Licensed Patent Rights and Licensed Technology, to Develop, have Developed,
Commercialize, have Commercialized, make, have made, use, have used, sell, have
sold, offer for sale, import, have imported, export and have exported any and
all Licensed Products in the Territory.

 

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

 

(a)                                   Voluntary
Termination by Biogen Idec.  Biogen
Idec shall have the right to terminate this Agreement at anytime upon providing
at least [***] ([***])
days prior written notice to ImmunoGen.

 

(b)                                  Breach.  A Party may terminate this Agreement and the
licenses granted herein, effective upon written notice to the other Party, upon
any breach by the other Party of any material obligation or condition of this
Agreement, which material breach remains uncured [***]
([***]) days after the non-breaching
Party gives a first written notice to the other Party describing such breach in
reasonable detail; provided, however, that in the event of a
payment breach by Biogen Idec under this Agreement, the applicable cure period
shall be [***] ([***])
days (in lieu of [***] ([***])
days) but the other terms of this Section 8.2(b) shall apply to termination in
connection with any such payment breach. 
Notwithstanding anything set forth herein, if the asserted material
breach is cured or shown to be non-existent within the applicable cure period,
the first notice of breach hereunder shall be deemed automatically withdrawn
and of no effect.

 

(c)                                   Bankruptcy.  A Party may terminate this Agreement,
effective on written notice to the other Party, in the event the other Party
shall have become insolvent or bankrupt, or shall have made an assignment for
the benefit of its creditors, or there shall have been appointed a trustee or
receiver of the other Party or for all or a substantial part of its property,
or any case or proceeding shall have been commenced or other action taken by or
against the other Party in bankruptcy or seeking reorganization, liquidation,
dissolution, winding-up, arrangement, composition or readjustment of its debts
or any other relief under any bankruptcy, insolvency, reorganization or other
similar act or law of any jurisdiction now or hereafter in effect, or there
shall have been issued a warrant of attachment, execution, distraint or similar
process against any substantial part of the property of the other Party, and
any such foregoing events shall have continued for [***]
([***]) days undismissed, unbonded and
undischarged.  All rights and

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

47

 

licenses granted under this Agreement are, and shall
be deemed to be, for purposes of Section 365(n) of the United States
Bankruptcy Code, licenses of rights to “intellectual property” as defined under
Section 101(56) of the United States Bankruptcy Code.  The Parties agree that in the event of the
commencement of a bankruptcy proceeding by or against one Party hereunder under
the United States Bankruptcy Code, the other Party shall be entitled to
complete access to any such intellectual property, and all embodiments of such
intellectual property, pertaining to the rights granted in the licenses
hereunder of the Party by or against whom a bankruptcy proceeding has been
commenced, subject, however, to payment of the milestone amounts and royalties
set forth in this Agreement through the effective date of any termination
hereunder.

 

8.3                               Effects
of Termination.  Upon any
termination of this Agreement by ImmunoGen under Section 8.2(b), as of the
effective date of such termination, all relevant licenses and sublicenses
granted by ImmunoGen to Biogen Idec hereunder shall terminate
automatically.  Notwithstanding the
foregoing, (a) no such termination of this Agreement shall be construed as a
termination of any valid sublicense of any Sublicensee hereunder, and
thereafter each such Sublicensee shall be considered a direct licensee of
ImmunoGen, provided, that, (i) such Sublicensee is then in full
compliance with all terms and conditions of its sublicense, (ii) all accrued
payments obligations to ImmunoGen have been paid, and (iii) such Sublicensee
agrees to assume all obligations of Biogen Idec under this Agreement within ten
(10) business days of ImmunoGen having given notice to the Sublicensee of such
termination and of all obligations of Biogen Idec under this Agreement, and (b)
Biogen Idec and its Sublicensees shall have the right, for [***]
([***]) months or such longer time
period (if any) on which the Parties mutually agree in writing, to sell or
otherwise dispose of all inventoried Licensed Products then on hand, with
royalties to be paid to ImmunoGen on all Net Sales of such Licensed Products as
provided for in this Agreement.

 

8.4                               Remedies. 
Except as otherwise expressly set forth in this Agreement, the
termination provisions of this Section 8 are in addition to any other
relief and remedies available to either Party at law.

 

8.5                               Surviving
Provisions.  Notwithstanding any provision herein to the
contrary, the rights and obligations of the Parties set forth in Sections 2.3,
3.3(e), 4.5(b), 4.5(c), 4.5(d), 5.9(b), 6, 7.2, 7.4, 7.5, 8.1, 8.3, 8.4, 8.5,
9.3, 10 and 11 as well as any rights or obligations otherwise

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

48

 

accrued hereunder (including any accrued payment
obligations), shall survive the expiration or termination of the Term of this
Agreement. Without limiting the generality of the foregoing, Biogen Idec shall
have no obligation to make any milestone or royalty payment to ImmunoGen that
has not accrued prior to the effective date of any termination of this
Agreement, but shall remain liable for all such payment obligations accruing
prior to the effective date of such termination.

 

9.                                      REPRESENTATIONS AND WARRANTIES

 

9.1                               ImmunoGen
Representations.  ImmunoGen
represents and warrants to Biogen Idec that: 
(a) the execution and delivery of this Agreement and the performance of
the transactions contemplated hereby have been duly authorized by all
appropriate ImmunoGen corporate action; (b) this Agreement is a legal and valid
obligation binding upon ImmunoGen and enforceable in accordance with its terms,
and the execution, delivery and performance of this Agreement by the Parties
does not conflict with any agreement, instrument or understanding to which
ImmunoGen is a party or by which it is bound; (c) ImmunoGen has the full right
and legal capacity to grant the licenses and rights to Biogen Idec pursuant to
Section 2 above without violating the rights of any Third Party or any
agreements between ImmunoGen or its Affiliates and any Third Party; (d) to
ImmunoGen’s knowledge, no Patent Rights within the Licensed Patent Rights are
invalid or unenforceable and as of the Effective Date no patents within the
Licensed Patent Rights have expired; (e) to ImmunoGen’s knowledge, it has
disclosed to Biogen Idec all facts known to ImmunoGen as of the Effective Date
that ImmunoGen believes to be materially relevant to the patentability,
validity and enforceability of the Licensed Patent Rights; (f) during the Term
of the Agreement, ImmunoGen will not take any action that it reasonably
believes would in any material way prevent it from granting the rights granted
to Biogen Idec under this Agreement with respect to Licensed Patent Rights or Licensed
Technology Controlled by ImmunoGen after the Effective Date; (g) to ImmunoGen’s
knowledge, but without conducting any independent patent search of any kind, it
is not aware of any issued patents claiming inventions relating to Licensed
Technology or Licensed Patent Rights owned or controlled by an ImmunoGen
Affiliate or a Third Party which would be infringed by the use of Licensed
Patents to manufacture, sell, use or import Licensed Products as contemplated
by this

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

49

 

Agreement, and as of the Effective Date, ImmunoGen is
not aware of any infringement by a Third Party of the Licensed Patent Rights;
(h) ImmunoGen has not received any notice from any Third Party claiming that
patents owned or controlled by such Third Party are being infringed by it in
the course of its conduct in substantially the same activities under Licensed
Patent Rights as are contemplated in the research, Development and
Commercialization of Licensed Products under this Agreement; and, (i) except as
otherwise disclosed by ImmunoGen to Biogen Idec as of the Effective Date,
ImmunoGen’s agreements with its Qualified ImmunoGen MAY Licensees in effect as
of the Effective Date include Substantially Similar Grant Back Rights (as that
term is defined in Section 2.3 (a) above).

 

9.2                               Biogen
Idec Representations.  Biogen
Idec represents and warrants to ImmunoGen that: 
(a) the execution and delivery of this Agreement and the performance of
the transactions contemplated hereby have been duly authorized by all
appropriate Biogen Idec corporate action; and (b) this Agreement is a legal and
valid obligation binding upon Biogen Idec and enforceable in accordance with
its terms, and the execution, delivery and performance of this Agreement by the
Parties does not conflict with any agreement, instrument or understanding to
which Biogen Idec is a party or by which it is bound.

 

9.3                               No Warranties.

 

(a)                                   Except
as specifically set forth in Section 9.1, nothing in this Agreement is or shall
be construed as:

 

(i)                                     a
warranty or representation by ImmunoGen as to the validity or scope of any
patent application or patent within the Licensed Patent Rights;

 

(ii)                                  a
warranty or representation that anything made, used, sold or otherwise disposed
of under any license granted in this Agreement is or will be free from
infringement of patents, copyrights, and other rights of Third Parties.

 

(b)                                  Except
as expressly set forth in this Agreement, NEITHER PARTY MAKES ANY
REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED.  WITHOUT LIMITING THE FOREGOING,
THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, THAT ANY LICENSED PRODUCT WILL BE SUCCESSFULLY DEVELOPED OR
MARKETED, OR THAT THE DEVELOPMENT,

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

50

 

MANUFACTURE, SALE, IMPORTATION OR USE OF THE LICENSED
PRODUCT(S) WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER RIGHTS,
OR ANY OTHER EXPRESS OR IMPLIED WARRANTIES.

 

10.                               INDEMNIFICATION; LIABILITY

 

10.1                        Indemnification.

 

(a)                                   Biogen
Idec Indemnity.  Subject to
Section 10.1(b) below and the remainder of this Section 10, Biogen
Idec shall indemnify, defend and hold harmless ImmunoGen, its Affiliates and
their respective directors, officers, employees, and agents and their
respective successors, heirs and assigns (the “ImmunoGen Indemnitees”), from and against any
liability, damage, loss or expense (including reasonable attorneys’ fees and
expenses of litigation) incurred by or imposed upon such ImmunoGen Indemnitees,
or any of them, in connection with any Third Party claims, suits, actions,
demands or judgments, including, without limitation, personal injury and
product liability matters, that arise out of or relate to (i) any actions or
omissions of Biogen Idec or any Affiliate or Sublicensee of Biogen Idec, in the
development, testing, production, manufacture, supply, promotion, import, sale
or use by any person of any Licensed Product (or any component thereof)
manufactured or sold by Biogen Idec or any Affiliate or Sublicensee of Biogen
Idec, under this Agreement, (ii) any material breach of this Agreement by
Biogen Idec, or (iii) the gross negligence or willful misconduct on the part of
Biogen Idec, its Affiliates or their respective employees or agents, except to
the extent of ImmunoGen’s responsibility therefor under Section 10.1(b)
below.

 

(b)                                  ImmunoGen
Indemnity.  Subject to
Section 10.1(a) above and the remainder of this Section 10, ImmunoGen
shall indemnify, defend and hold harmless Biogen Idec, its Affiliates and their
respective directors, officers, employees, and agents, and their respective
successors, heirs and assigns (the “Biogen Idec Indemnitees”), from and against any liability, damage, loss or
expense (including reasonable attorneys’ fees and expenses of litigation)
incurred by or imposed upon such Biogen Idec Indemnitees, or any of them, in
connection with any Third Party claims, suits, actions, demands or judgments,
including, without limitation, personal injury and product liability matters,
that arise out of or relate to (i) any material breach of this Agreement by
ImmunoGen, or (ii) the gross negligence or willful

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

51

 

misconduct on the part of ImmunoGen, its Affiliates or
their respective employees or agents, except to the extent of Biogen Idec’s
responsibility therefor under Section 10.1(a) above.

 

10.2                        Indemnification
Procedures.  In the event that
any Indemnitee is seeking indemnification under Section 10.1 above from a
Party (the “Indemnifying Party”),
the other Party shall notify the Indemnifying Party of such claim with respect
to such Indemnitee as soon as reasonably practicable after the Indemnitee
receives notice of the claim, and the Party (on behalf of itself and such
Indemnitee) shall permit the Indemnifying Party to assume direction and control
of the defense of the claim (including the right to settle the claim solely for
monetary consideration) and shall cooperate as requested (at the expense of the
Indemnifying Party) in the defense of the claim.

 

10.3                        Liability.  NOTWITHSTANDING ANYTHING ELSE IN THIS
AGREEMENT OR OTHERWISE, NEITHER PARTY WILL BE LIABLE WITH RESPECT TO ANY
SUBJECT MATTER OF THIS AGREEMENT UNDER ANY CONTRACT, NEGLIGENCE, STRICT
LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR ANY INDIRECT, INCIDENTAL,
CONSEQUENTIAL OR PUNITIVE DAMAGES OR LOST PROFITS OR COST OF PROCUREMENT OF
SUBSTITUTE GOODS, TECHNOLOGY OR SERVICES.

 

11.                               MISCELLANEOUS

 

11.1                        Entire
Agreement; Amendments.  This is
the entire Agreement between the Parties with respect to the subject matter
herein, and supersedes any prior agreements, understandings, negotiations or
correspondence between the Parties respecting the subject matter hereof,
whether written or verbal (including, without limitation, the MTA, and that
certain Confidentiality Agreement effective [***],
[***]. 
No modification or other amendment of this Agreement shall be effective
unless in writing and signed by a fully authorized representative of each
Party.

 

11.2                        Waiver.  The terms or conditions of this Agreement may
be waived only by a written instrument executed by a duly authorized
representative of the Party waiving compliance. 
The failure of either Party at any time or times to require performance
of any provision hereof shall in no manner affect its rights at a later time to
enforce the same.  No waiver by either
Party

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

52

 

of any condition or term shall be deemed as a
continuing waiver of such condition or term or of another condition or term.

 

11.3                        Governing
Law.  This Agreement will be
construed, interpreted and applied in accordance with the laws of the
Commonwealth of Massachusetts applicable to contracts entered into and to be
performed entirely within the Commonwealth of Massachusetts without giving
effect to any choice of law principles that would require the application of
the laws of a different state. 
Notwithstanding the foregoing, any dispute, controversy or claim arising
out of this Agreement relating to the scope, validity, enforceability or
infringement of any Patent Rights or other intellectual property rights shall
be submitted to a court of competent jurisdiction in the territory in which
such Patent Rights or other intellectual property rights were granted or arose.

 

11.4                        Notices.  Any notices, requests, deliveries, approvals
or consents required or permitted to be given under this Agreement to Biogen
Idec or ImmunoGen shall be in writing and shall be personally delivered or sent
by telecopy (with machine confirmation of transmission) or by overnight courier
providing evidence of receipt or certified mail, return receipt requested,
postage prepaid, in each case to the respective address specified below (or to
such address as may be specified in writing to the other Party hereto):

 

	
  If to ImmunoGen:

  	
   

  	
  ImmunoGen, Inc.

  
	
   

  	
   

  	
  128 Sidney Street

  
	
   

  	
   

  	
  Cambridge, MA 02139

  
	
   

  	
   

  	
  Attn: Chief Executive
  Officer

  
	
   

  	
   

  	
  Fax: (617) 995-2510

  
	
   

  	
   

  	
   

  
	
  with a copy to

  	
   

  	
  Mintz, Levin, Cohn,
  Ferris, Glovsky and Popeo, P.C.

  
	
   

  	
   

  	
  One Financial Center

  
	
   

  	
   

  	
  Boston, MA 02111

  
	
   

  	
   

  	
  Attn: [***]. [***], Esq.

  
	
   

  	
   

  	
  Fax: (617) 542-2241

  
	
   

  	
   

  	
   

  
	
  If to Biogen Idec:

  	
   

  	
  Biogen Idec MA Inc.

  
	
   

  	
   

  	
  14 Cambridge Center

  
	
   

  	
   

  	
  Cambridge, MA 02142

  
	
   

  	
   

  	
  Attn: Executive Vice
  President, Business Development

  
	
   

  	
   

  	
  Fax: (617) 679-2617

  
	
   

  	
   

  	
   

  
	
  with a copy to

  	
   

  	
  Biogen Idec MA Inc.

  
	
   

  	
   

  	
  14 Cambridge Center

  

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

53

 

	
   

  	
   

  	
  Cambridge, MA 02142

  
	
   

  	
   

  	
  Attn: Executive Vice
  President and General Counsel

  
	
   

  	
   

  	
  Fax: (617) 679-2838

  

 

Such notices shall be
deemed to have been sufficiently given on: 
(a) the date sent if delivered in person or transmitted by facsimile, or
(b) the next business day after dispatch in the case of overnight courier.

 

11.5                        No
Implied Licenses.  Except as
expressly set forth elsewhere in this Agreement, neither Party grants to the
other Party any right or license to any of its intellectual property.

 

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

 

11.7                        Assignment.  This Agreement may not be assigned by either
Party without the consent of the other, except that each Party may, without
such consent, assign this Agreement and the rights, obligations and interests
of such Party, in whole or in part, to any of its Affiliates, to any purchaser
of all or substantially all of its assets in the line of business to which this
Agreement pertains or to any successor corporation resulting from any merger or
consolidation of such Party with or into such corporations.

 

11.8                        Force
Majeure.  Neither Party shall be
liable for failure of or delay in performing obligations set forth in this
Agreement, and neither shall be deemed in breach of its obligations, if such
failure or delay is due to natural disasters or any causes beyond the
reasonable control of such Party.  In
event of such force majeure, the Party affected thereby shall use reasonable
efforts to cure or overcome the same and resume performance of its obligations
hereunder.

 

11.9                        Construction.  The Parties hereto acknowledge and agree
that:  (a) each Party and its
counsel reviewed and negotiated the terms and provisions of this Agreement and
have contributed to its revision; (b) the rule of construction to the
effect that any ambiguities are resolved against the drafting Party shall not
be employed in the interpretation of this Agreement; and (c) the terms and
provisions of this Agreement shall be construed fairly as to each Party hereto
and not in a favor of or against any Party, regardless of which Party was
generally responsible for the preparation of this Agreement.

 

11.10                 Severability.  If any provision(s) of this Agreement are or
become invalid, are ruled illegal by any court of competent jurisdiction or are
deemed unenforceable under then

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

54

 

current applicable law from time to time in effect
during the term hereof, it is the intention of the Parties that the remainder
of this Agreement shall not be affected thereby provided that a Party’s rights
under this Agreement are not materially affected.  The Parties hereto covenant and agree to
renegotiate any such term, covenant or application thereof in good faith in
order to provide a reasonably acceptable alternative to the term, covenant or
condition of this Agreement or the application thereof that is invalid, illegal
or unenforceable, it being the intent of the Parties that the basic purposes of
this Agreement are to be effectuated.

 

11.11                 Status.  Nothing in this Agreement is intended or
shall be deemed to constitute a partner, agency, employer-employee, or joint
venture relationship between the Parties.

 

11.12                 Dispute
Resolution.  The Parties
recognize that a bona fide dispute as to certain matters may from time to time
arise during the term of this Agreement relating to either Party’s rights
and/or obligations hereunder or otherwise relating to the validity,
enforceability or performance of this Agreement, including disputes relating to
alleged breach or termination of this Agreement but excluding any determination
of the validity of the Parties’ patents (hereinafter, a “Dispute”).  In the event of the occurrence of any such
Dispute, the Parties shall, by written notice to the other Party, have such
dispute referred to their respective senior officers designated below (and to
any designated officer of a Biogen Idec Sublicensee, if such Dispute involves
such Sublicensee), for attempted resolution by good faith negotiations
commencing promptly after such notice is received.  Said designated senior officials of the
Parties are as follows:

 

	
  For Biogen Idec:

  	
   

  	
  Chief Executive
  Officer; and

  
	
  For ImmunoGen:

  	
   

  	
  Chief Executive
  Officer.

  

 

In the event the
designated senior officials are not able to resolve such Dispute, the Parties
may seek to mediate their Dispute, on terms and with a mediator mutually
agreeable to the Parties.

 

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

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

55

 

11.14                 Counterparts.  This Agreement may be executed simultaneously
in one or more counterparts, each of which shall be deemed an original, but all
of which together shall constitute one and the same instrument.

 

[Remainder
of page intentionally left blank.]

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

56

 

IN WITNESS WHEREOF, the
Parties have caused this Agreement to be executed by their duly authorized
representative in two (2) originals.

 

 

	
  BIOGEN IDEC MA INC.

  	
  IMMUNOGEN, INC.

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
  /s/
  Michael Gilman, Ph.D.

  	
   

  	
  By:  

  	
  /s/
  Pauline Jen Ryan

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Name: 

  	
  Michael Gilman, Ph.D.

  	
   

  	
  Name:

  	
  Pauline Jen Ryan

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Title: 

  	
    Executive Vice President,
  Research

  	
   

  	
  Title: 

  	
   Senior Vice
  President, Business 

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   Development

  	
   

  
													

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

57

 

SCHEDULE
A

 

LICENSED
PATENT RIGHTS

 

[*******************]

 

[*************************************************************************]

 

	
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  [***]

  	
   

  	
  [***]

  

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

58

 

	
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[******************************************************************************************]

 

[***************************************************************************]

 

	
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  [***]

  	
   

  	
  [***]

  

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

59

 

	
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[*********************************]

 

[*********************************************************************************]

 

	
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  [***]

  

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

60

 

	
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[********************************************************]

 

[**************************************************************************************************]

 

	
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[****************]

 

[************************************************************************************************]

 

	
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  [***]

  	
   

  	
  [***]

  

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

61

 

	
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[********************************************************************************************]

 

	
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[*************************************************************]

 

	
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[************************************************************************]

 

	
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  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

62

 

	
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[**********************************]

 

[******************************************************]

 

	
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[*****************]

 

[*********************************************************************************************************]

 

	
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  [***]

  	
   

  	
  [***]

  

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

63

 

[**********************************]

 

[*********************************************************************************************************]

 

	
  [***]

  	
   

  	
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[****************]

 

[********************************************************************************************************]

 

	
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  [***]

  	
   

  	
  [***]

  

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

64

 

	
  [***]

  	
   

  	
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  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  	
   

  	
  [***]

  

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

65

 

SCHEDULE
B

 

PROVISIONS
FOR SUPPLY AGREEMENTS

 

[***]
Supply Agreements [***]

 

[***************************************************************]

 

[***************************************************************]

 

[********************************************************************************************************

*************************************************************************************]

 

[********************************************************************************************************

*************************************************************************************]

 

[********************************************************************************************************

*********************************************************************************************************

********************************************************************************************]

 

[********************************************************************************************************

*************************************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[********************************************************************************************************

*************************************************************************************]

 

[***************************************************************]

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

66

 

SCHEDULE C

 

POLYPEPTIDE
SEQUENCES OF [***] [***]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

67

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

[***************************************************************]

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application
requesting confidential investment under Rule 24b-2 under the Securities
Exchange Act of 1934.

 

68

 

SCHEDULE
D

 

FORM OF
ROYALTY REPORT

 

[********]

 

[*********************]

 

[******]

 

	
  [*****]                    [***]

  	
   

  	
  [******]

  	
   

  	
  [*******]

  	
   

  	
  [******]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [******]

  	
   

  	
  [***]

  	
   

  	
   

  	
   

  	
  [***]

  	
   

  

 

 

CONFIDENTIAL

Portions of this Exhibit were omitted and have been filed separately
with the Secretary of the Commission pursuant to the Company's application requesting
confidential investment under Rule 24b-2 under the Securities Exchange Act of
1934.

 

69Exhibit 10.2

 

DEVELOPMENT AND LICENSE AGREEMENT

 

This
Development and License Agreement (this “Agreement”) is made effective as of December 23,
2004 (the “Effective Date”) by and between Centocor, Inc., a wholly owned
subsidiary of Johnson & Johnson, with its principal place of business at
200 Great Valley Parkway, Malvern, Pennsylvania 19355 (“Centocor”), and
ImmunoGen, Inc., a Massachusetts corporation with its principal place of
business at 128 Sidney Street, Cambridge, Massachusetts 02139 (“ImmunoGen”).  Centocor and ImmunoGen are sometimes each
hereinafter referred to individually as a “Party” and collectively as the “Parties”.

 

WHEREAS,
Centocor is the owner of or otherwise controls certain rights in proprietary
technology and know-how relating to certain [*******************] Antibodies
(as defined below); and

 

WHEREAS,
ImmunoGen is the owner of or otherwise controls certain rights in proprietary
technology and know-how relating to or otherwise useful in the conjugation of
maytansine derivatives to binding proteins; and

 

WHEREAS,
pursuant to the terms and conditions set forth herein, Centocor desires to
obtain from ImmunoGen, and ImmunoGen desires to grant to Centocor, a license
under certain of ImmunoGen’s Technology and/or Patent Rights to develop and
commercialize one or more Licensed Products (as defined below).

 

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

 

1.                                      DEFINITIONS

 

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

 

1.1.                            “Adverse Event” shall mean any untoward medical occurrence in a patient or
subject who is administered a Licensed Product, whether or not considered
related to the Licensed Product including, without limitation, any undesirable
sign (including abnormal

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

 

laboratory
findings of clinical concern), symptom or disease temporally associated with
the use of such Licensed Product.

 

1.2.                            “Affiliate” shall mean any
corporation, firm, limited liability company, partnership or other entity which
directly or indirectly controls or is controlled by or is under common control
with a Party to this Agreement.  For purposes of this Section 1.2, “control”
means ownership, directly or indirectly through one or more Affiliates, of
fifty percent (50%) or more of the shares of stock entitled to vote for the
election of directors, in the case of a corporation, or fifty percent (50%) or
more of the equity interests in the case of any other type of legal entity, or
status as a general partner in the case of any partnership, or any other
arrangement whereby a Party controls or has the right to control the Board of Directors
or equivalent governing body or management of a corporation or other entity.

 

1.3.                            “Agreement” shall mean this
Development and License Agreement between the Parties, dated as of the
Effective Date, including any
exhibits, schedules or other attachments hereto and incorporated herein, as any
of the foregoing may be validly amended from time to time.  In the event of any inconsistency between the
terms of this Agreement and the terms of any exhibits, schedules or other
attachments incorporated herein, unless the Parties expressly agree otherwise
in writing the terms of this
Agreement shall govern.

 

1.4.                            [***************************]
shall mean any [**************************] consisting of an [**************]
in [*********************************].

 

1.5.                            [***************************]-MAY Conjugate” shall mean any
conjugate of an [********************************] Antibody with a MAY
Compound.

 

1.6.                            “Ansamitocins” shall mean
precursor(s) of MAY Compound produced by microbial fermentation, such as
Ansamitocin P0, P1, P2, P3, P3’, P4, and P4’.

 

1.7.                            [***************************]
Antibody” shall mean any Antibody
(including [********] that is Controlled by Centocor and that targets
[*************************].

 

1.8.                            “Antibody” shall mean a composition
comprising a whole antibody or fragment

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

2

 

thereof (whether
polyclonal or monoclonal, human, humanized, chimeric or murine, or derived from
another relevant species, multiple or single chain, recombinant, transgenic
animal derived or naturally occurring, and any
constructs thereof) or having been derived from nucleotide sequences encoding,
or amino acid sequences of, such an antibody or fragment.

 

1.9.                            “Centocor Background Technology”
means any Technology used by Centocor or provided
by Centocor for use, in the Research Program that is useful in the Field and
that is (a) Controlled by Centocor as of the Effective Date or (b) Controlled
by Centocor and developed or conceived by employees of, or consultants to,
Centocor on and after the Effective Date in the conduct of activities outside
the Research Program and without the use of any Licensed Technology, Licensed
Patent Rights or Joint Program Technology.  
Any Centocor Background Technology Controlled by Centocor as of the
Effective Date is, or that becomes Controlled by Centocor on and after the
Effective Date shall be, described in Schedule C attached hereto
and incorporated herein by reference.

 

1.10.                     “Centocor Patent Rights” shall mean
all Patent Rights with respect to Centocor Background Technology.

 

1.11.                     “Centocor Program Technology” shall
mean any Program Technology made solely by employees of, or others obligated to
assign inventions to, Centocor or any Affiliate of Centocor.

 

1.12.                     “Clinical Materials” shall mean any MAY Compound or Licensed Product supplied by ImmunoGen to Centocor pursuant to Section 4.3
and/or the terms of a Supply Agreement for use in human
clinical testing.

 

1.13.                     “Collaboration Committee”
shall mean the committee with representatives of each Party established as set
forth in Section 3.4.

 

1.14.                     [***************************************]
shall mean a [*****] of [************] in [********************] to
[***************] of [********] of [****************] to
[***********************************] and [********] launch of a product
incorporating MAY Compound.

 

1.15.                     “Commercialization” or “Commercialize” shall mean any and all
activities

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

3

 

directed to pre-launch
and launch of Licensed Products, including marketing, promoting, distributing,
offering for sale and selling such Licensed Product, importing Licensed
Products for sale, manufacturing for commercial sale (except for scale-up
activities, which shall be Development activities) and securing reimbursement
for sales. When used as a verb, “Commercialize” shall mean to engage in
Commercialization.

 

1.16.                     “Confidential Information” shall mean,
with respect to a Party (the “receiving Party”), all information which is
disclosed by the other Party (the “disclosing Party”) to the receiving Party
hereunder or to any of its employees, consultants, Affiliates, licensees or
sublicensees, except to the extent that the receiving Party can demonstrate by
written record or other suitable physical evidence that such information, (a) as
of the date of disclosure is demonstrably known to the receiving Party or its
Affiliates other than by virtue of a prior confidential disclosure to such
Party or its Affiliates; (b) as of the date of disclosure is in, or
subsequently enters, the public domain, through no fault or omission of the
receiving Party; (c) is obtained from a Third Party having a lawful right
to make such disclosure free from any obligation of confidentiality to the
disclosing Party; or (d) is independently developed by or for the
receiving Party without reference to or reliance upon any Confidential
Information of the Disclosing Party.  For
purposes of clarity, (a) any technical or financial information of a disclosing
Party disclosed at any meeting of the Collaboration Committee, or disclosed
through an audit report shall constitute Confidential Information of such
disclosing Party, (b) the terms of this Agreement, to the extent not disclosed
in a public filing (or press release permitted under Section 6 of this
Agreement, shall constitute Confidential Information of each Party unless
otherwise specified, (c) all know-how and trade secrets disclosed by ImmunoGen
to Centocor in connection with the licenses set forth in Section 2.1 of
this Agreement shall constitute Confidential Information of ImmunoGen, and (d)
all know-how and trade secrets disclosed by Centocor to ImmunoGen in connection
with the license set forth in Section 2 of this Agreement shall constitute
Confidential Information of Centocor.

 

1.17.                     “Consumer Price Index or “CPI”
shall mean the CPI for All Urban Consumers published from time to time by the
Bureau of Labor Statistics of the United States Department of 

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

4

 

Labor.

 

1.18.                     “Contract Year” shall mean the period
beginning on the Effective Date and ending on December 31, 2005 and each
succeeding twelve (12) month period thereafter during the Term.

 

1.19.                     “Control” or “Controlled”
shall mean, with respect to any Patent Rights, Technology or Proprietary
Materials (including, without limitation, any MAY Compound,
[*********************************] Antibody or other proprietary biologic
material covered under this Agreement), the possession by a Party of the
ability to grant a license or sublicense of such Patent Rights or Technology and
the rights thereto or to supply such Proprietary Materials as provided for in
this Agreement without violating the terms of any arrangement or agreement
between such Party or its Affiliates and any Third Party.

 

1.20.                     “Cost” shall mean, with respect to any
Preclinical Materials or Clinical Materials manufactured by ImmunoGen,
ImmunoGen’s fully-burdened costs (including the costs associated with product
testing and release activities) of producing and packaging such Preclinical or
Clinical Materials, including the sum of the following components:  (a) direct costs, including (1) materials
directly used in producing and packaging such Preclinical Materials or Clinical
Materials and (2) with respect to any Preclinical Materials or Clinical
Materials obtained by ImmunoGen from a Third Party and supplied to Centocor
without modification, the amount paid by ImmunoGen to such Third Party for the
same; (b) manufacturing overhead costs attributable to the cost of goods under
the foregoing clause (a) (1), including manufacturing and quality labor and
manufacturing and quality supervisory services, operating and administrative
costs of the manufacturing and quality departments and occupancy costs which
are allocable to company departments based on space occupied or headcount, or
another activity-based method; (c) any other reasonable and customary
out-of-pocket costs borne by ImmunoGen for the testing, transport, customs
clearance, duty, insurance and/or storage of such Preclinical Materials or
Clinical Materials; and (d) ImmunoGen’s general and administrative costs,
including purchasing, human resources, payroll, information system and
accounting, which are directly attributable or reasonably allocable to company
departments

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

5

 

based on space occupied
or headcount or another activity-based method. 
In no event shall Manufacturing Costs include costs associated with idle
capacity.  Manufacturing overhead costs
under the foregoing clause (b) and general and administrative costs under the
foregoing clause (d) are allocable to each batch of Preclinical Material and/or
Clinical Material produced based upon the [******] of [******], or any portion
of a [****], that a Manufacturing [*****] is [**********] for the [**********]
(including [*****************] and [*******]) if Preclinical Materials or
Clinical Materials, as the use may be, at ImmunoGen’s facilities.  Notwithstanding the foregoing, Cost shall not
include the cost of purchasing any Dedicated Equipment pursuant to Section 4.4
of this Agreement.

 

1.21.                     “Dedicated Equipment” shall mean any equipment, instrument or
machinery used by ImmunoGen exclusively in the manufacturing of Preclinical
Materials or Clinical Materials.

 

1.22.                     “Development” and “Develop” shall mean, with respect
to any Licensed Product, all activities with respect to such Licensed Product
relating to research and development in connection with seeking, obtaining
and/or maintaining any Regulatory Approval for such Licensed Product in the
Field in the Territory, including without limitation, all pre-clinical research
and development activities, test method development and stability testing,
toxicology, formulation, process development, manufacturing scale-up,
development-stage manufacturing, quality assurance/quality control development
and performance, all activities relating to developing the ability to
manufacture any Licensed Product or any component thereof (including, without
limitation, process development work), and all other activities relating to
seeking, obtaining and/or maintaining any Regulatory Approvals from the FDA
and/or any Foreign Regulatory Authority.

 

1.23.                     “Drug Approval Application” shall
mean any application for Regulatory Approval (including pricing and
reimbursement approvals) required prior to any commercial sale or use of a
Licensed Product in any country or jurisdiction in the Territory, including,
without limitation, (a) any NDA or other regulatory application filed with the
FDA prior to any commercial sale or use of a Licensed Product in the United States,
and (b) any MAA or other

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

6

 

equivalent regulatory
application filed with any Foreign Regulatory Authority for Regulatory Approval
(including pricing and reimbursement approvals) required prior to any
commercial sale or use of a Licensed Product in any other country or
jurisdiction in the Territory.

 

1.24.                     “Effective Date” shall mean the date
first written above in the introductory paragraph to this Agreement.

 

1.25.                     “FDA” shall mean the United States
Food and Drug Administration and any successor agency or authority thereto.

 

1.26.                     “Field” shall mean all human
therapeutic uses.

 

1.27.                     “First Commercial Sale” shall mean
the date of the first commercial transfer or disposition for value to a Third
Party of a Licensed Product by or on behalf of Centocor or any Affiliate or
Sublicensee of Centocor.

 

1.28.                     “Foreign Regulatory Authority” shall
mean any applicable supranational, national, federal, state or local regulatory
agency, department, bureau or other governmental entity of any country or
jurisdiction in the Territory (other than the FDA in the United States),
including, without limitation, the Europeon Medicines Agency, having
responsibility in such country or jurisdiction for any Regulatory Approvals of
any kind in such country or jurisdiction, and any successor agency or authority
thereto.

 

1.29.                     “Full Time Equivalent” or “FTE” a full time person dedicated to
the Research Program, or in the case of less than a full-time dedicated person,
a full-time, equivalent person year, based on a total of at least [************] or [*******************]
per year of work, on or directly related to the Research Program, and which is
carried out by employees, contractors or agents of ImmunoGen having the
appropriate scientific expertise to conduct such activities.

 

1.30.                     “FTE Cost” shall mean, for any period
during the Term of this Agreement, the FTE Rate multiplied by the number of
FTEs expended over such period.

 

1.31.                     “FTE Rate” shall mean, for the [*****]
Contract Year commencing on the Effective Date, [*************]; and, for each
Contract Year thereafter, the result obtained by multiplying [*************] by
the sum of (1+CPI) where CPI is a fraction, the numerator of

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

7

 

which is the difference
between the Consumer Price Index as of the last month of the immediately
preceding Contract Year and the Consumer Price Index as of the month
immediately preceding the Effective Date and the denominator of which is the
Consumer Price Index as of the month immediately preceding the Effective Date.

 

1.32.                     “GMPs” shall mean all good
manufacturing practices under Title 21 of the United States Code of Federal
Regulations, as amended from time to time.

 

1.33.                     “ImmunoGen Materials” shall mean any
Proprietary Materials Controlled by ImmunoGen and used by ImmunoGen, or
provided by ImmunoGen for use, in the Research Program.  ImmunoGen Materials shall include, without
limitation, any MAY Compound.

 

1.34.                     “ImmunoGen Program Technology” shall
mean any Program Technology made solely by employees of, or agents or others
obligated to assign inventions to, ImmunoGen or an Affiliate of ImmunoGen.

 

1.35.                     “Improvement” shall mean any
enhancement, improvement or modification to the Licensed Technology or the
Licensed Patent Rights which is conceived or reduced to practice by either
Party in the conduct of the Research Program and/or in connection with the
development of any Licensed Product.

 

1.36.                     “IND” shall mean an investigational
new drug application (as defined in Title 21 of the United States Code of
Federal Regulations, as amended from time to time) filed or to be filed with
the FDA with regard to any Licensed Product.

 

1.37.                     “Indemnitees” and “Indemnifying Party” shall have the
meanings set forth in Section 9.

 

1.38.                     “Joint Program Technology” shall
mean any Program Technology made jointly by one or more employees of or agents
to, or other persons obligated to assign inventions to, ImmunoGen or an
ImmunoGen Affiliate, and by one or more employees of or agents to, or other persons
obligated to assign inventions to, Centocor or a Centocor Affiliate.

 

1.39.                     “Licensed Patent Rights” shall mean
any Patent Rights in the Field which are Controlled by ImmunoGen as of the
Effective Date or become Controlled by ImmunoGen during the Term (including
ImmunoGen’s interest in any ImmunoGen Program Technology and Joint

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

8

 

Program Technology
covered by Patent Rights that are Controlled by ImmunoGen), to the extent
necessary to Develop, have Developed, make, have made, use, sell, have sold,
import or export any Licensed Product in the Field in the Territory.  Licensed Patent Rights as of the Effective
Date are set forth in Schedule A attached hereto and incorporated
herein by reference.

 

1.40.                     “Licensed Product” shall mean any
product that incorporates, is comprised of, or is otherwise derived from, an
[***************]- MAY Conjugate.

 

1.41.                     “Licensed Technology” shall mean any
Technology in the Field which is Controlled by ImmunoGen as of the Effective
Date or becomes Controlled by ImmunoGen during the Term (including ImmunoGen’s interest in any ImmunoGen Program
Technology and Joint Program Technology), which is necessary or useful
to Develop, have Developed, make, have made, use, sell, have sold, import or export
any Licensed Product in the Field in the Territory.

 

1.42.                     “MAA” shall mean an application
filed with the relevant Foreign Regulatory Authorities in Europe seeking
Regulatory Approval to market and sell any Licensed Product in Europe or any
country or territory therein for a particular indication within the Field.

 

1.43.                     [*****************************]
shall mean the [*********] of (a) an [*****] (such [*****] to [*****] the
[****] under (b) below) of a [****************] by [******] that [*******************]
to [******************] that the [*******************] is [*******] of using
[***********************************] to [********************
****************] to [**********************] in terms of
[************************] and [***************] for [*********] to be used in
(i) [***************************] involving [**************] and (ii)
[******************************] of a [****************], and (b) the
[*********] by [*********] or [******] and [************ *************] of a
[***************] that [*********************************] is [***********]
with the [*****] of [*******] as described under (a) above.  For the avoidance of doubt, if [*******]
chooses [***] to [*******] the [*****] under (a) above [*****] to the
[********] of the [****************] referenced under (b) above, the
[****************** *************] will be [**************] and

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

9

 

[*********] upon the
[*********] of only (b) above.

 

1.44.                     “MAY Compound” shall mean any and
all maytansinoid compounds and any and all derivatives of any such maytansinoid
compounds, to the extent, in any case, Controlled by ImmunoGen, including
without limitation, (a) N2’-deacetyl-N2’-(3-mercapto-1-oxopropyl)-maytansine
(CAS No. 139504-50-0) (commonly referred to as DM1); (b) N2’-deacetyl-N2-(4-mercapto-1-oxopentyl)-maytansine
(commonly referred as DM3); and (c) N2’-deacetyl-N2-(4-mercapto-4-methyl-1-oxopentyl)-maytansine
(commonly referred as DM4).

 

1.45.                     “MTA”
shall mean that certain Material Transfer and Evaluation Agreement between
Centocor and ImmunoGen dated [***************], as amended on
[********************] and [********************].

 

1.46.                     “NDA” shall mean a new drug
application (as defined in Title 21 of the United States Code of Federal Regulations,
as amended from time to time) filed with the FDA seeking Regulatory Approval to
market and sell any Licensed Product in the United States for a particular
indication within the Field.

 

1.47.                     “Net Sales” shall mean, as to each
calendar quarter during the Term, the gross invoiced sales prices charged for
all Licensed Products sold by Centocor or its Sublicensees to Third Parties
throughout the Territory during such calendar quarter, less the following
amounts incurred or paid by Centocor or its Sublicensees during such calendar
quarter with respect to sales of Licensed Products regardless of the calendar
quarter in which such sales were made:

 

(a)                                   (i)
trade, cash and quantity discounts actually allowed or taken, including
discounts to governmental or managed care organizations; (ii) rebates actually
paid or credited, including government rebates such as Medicaid chargebacks or
rebates; (iii) retroactive price reductions or allowances actually allowed or
granted from the billed amount; and (iv) commercially reasonably promotional
allowances actually granted to customers as reflected on the same invoice as
for the sale of Licensed Product

 

(b)                                  credits
or allowances actually given or made for rejection of or return of, previously
sold Licensed Products;

 

(c)                                   any
charges for insurance, freight, and other transportation costs directly

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

10

 

related to the
delivery of Licensed Product to the extent included in the gross invoiced sales
price;

 

(d)                                  any
tax, tariff, duty or governmental charge levied on the sales, transfer,
transportation or delivery of a Licensed Product (including any tax such as a
value added or similar tax or government charge) borne by the seller thereof,
other than franchise or income tax of any kind whatsoever; and

 

(e)                                   any
import or export duties or their equivalent borne by the seller.

 

“Net Sales” shall not
include sales or transfers between Centocor and its Affiliates, unless the
Licensed Product is consumed by the Affiliates.

 

1.48.                     “Patent Rights” shall mean the
rights and interests in and to any and all issued patents and pending patent
applications (including inventor’s certificates and utility models) in any
country or jurisdiction in the Territory, including any and all provisionals,
non-provisionals, substitutions, continuations, continuations-in-part,
divisionals and other continuing applications, supplementary protection
certificates, renewals, and all letters patent on any of the foregoing, and any
and all reissues, reexaminations, extensions, confirmations, registrations and
patents of addition on any of the foregoing.

 

1.49.                     “Phase II Clinical Trial” shall
mean, as to a particular Licensed Product for a particular indication, a
controlled and lawful study in humans of the safety, dose ranging and efficacy
of such Licensed Product for such indication, which is prospectively designed
to generate sufficient data (if successful) to commence a Pivotal Clinical
Trial of such Licensed Product for such indication.

 

1.50.                     “Pivotal Clinical Trial”
shall mean, as to a particular Licensed Product for a particular indication, a
controlled and lawful study in humans of the safety and efficacy of such
Licensed Product for such indication, which is prospectively designed to
demonstrate statistically whether such Licensed Product is safe and effective
for use in such indication in a manner sufficient to file an NDA to obtain
Regulatory Approval to market and sell that Licensed Product in the United
States or in any other country in the Territory for the indication under
investigation in such study.

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

11

 

1.51.                     “Preclinical Materials” shall mean any MAY Compound and/or
[***************************]-MAY Conjugate supplied by ImmunoGen to Centocor
in accordance with Section 4.2 for the purpose of conducting research
activities and/or preclinical testing under the Research Program with respect
to a Licensed Product.

 

1.52.                     “Program Technology” shall mean any Technology, whether or not patentable, conceived or
reduced to practice in the conduct of the Research Program, or, during the
manufacture of Preclinical Material or Clinical Material in accordance with Section 4
of this Agreement.

 

1.53.                     “Proprietary Materials” shall mean any
tangible chemical, biological or physical research materials that are furnished
by or on behalf of one Party to the other Party in connection with this
Agreement, regardless of whether such materials are specifically designated as
proprietary by the transferring Party.

 

1.54.                     “Regulatory Approval” shall mean any
and all approvals (including pricing and reimbursement approvals), product and
establishment licenses, registrations or authorizations of any kind of the FDA
or any Foreign Regulatory Authority necessary for the development, pre-clinical
and/or human clinical testing, manufacture, quality testing, supply, use,
storage, importation, export, transport, marketing and sale of a Licensed
Product (or any component thereof) for use in the Field in any country or other
jurisdiction in the Territory.  “Regulatory
Approval” shall include, without limitation, any NDA, MAA or any other Drug
Approval Application.

 

1.55.                     “Regulatory Authority”
shall mean the FDA and/or a Foreign Regulatory Authority.

 

1.56.                     “Research Budget” shall
mean the budget for the Research Plan as agreed to by the parties.

 

1.57.                     “Research Plan” shall mean the written plan describing the
research activities to be carried out by each Party pursuant to this Agreement
attached hereto as Appendix 3.1.

 

1.58.                     “Research Program” shall mean the
research activities in the Field commencing on the Effective Date to be
conducted by the Parties pursuant to Section 3.1 of this
Agreement

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

12

 

and reflected in the
Research Plan.

 

1.59.                     “Sublicensee” shall mean any Third
Party to which Centocor grants a
sublicense of the rights granted to Centocor
pursuant to this Agreement.

 

1.60.                     “Technology” shall mean and include
any and all unpatented proprietary ideas, inventions, trade secrets,
discoveries, data, results, formulae, designs, specifications, methods,
processes, formulations, techniques, know-how, technical information
(including, without limitation, structural and functional information), process
information, pre-clinical information, clinical information, and any and all
Proprietary Materials, including all proprietary biological, chemical,
pharmacological, toxicological, pre-clinical, clinical, assay, control and
manufacturing data and materials.

 

1.61.                     “Term” shall mean the period
commencing on the Effective Date and continuing until the expiration or
termination of this Agreement in accordance with the terms hereof.

 

1.62.                     “Territory” shall mean all countries
and jurisdictions of the world.

 

1.63.                     “Third Party” shall mean, as to a
Party, any entity other than that Party and its respective Affiliates.

 

1.64.                     “Third Party Payments” shall have
the meaning set forth in Section 5.3.2.

 

1.65.                     “Upfront Fee” shall have the meaning set
forth in Section 5.1.1.

 

1.66.                     “Valid Claim” shall mean any claim
within an issued, unexpired patent or pending patent application within the
Licensed Patent Rights that (a) has not been finally cancelled, withdrawn,
abandoned or rejected by any administrative agency or other body of competent
jurisdiction, and (b) has not been revoked, held invalid, or declared
unpatentable or unenforceable in a decision of a court or other body of
competent jurisdiction that is unappealable or unappealed within the time
allowed for appeal, and (c) has not been rendered unenforceable through
disclaimer or otherwise, and (d) is not lost through an interference
proceeding.

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

13

 

2.                                      GRANT OF RIGHTS

 

2.1                               License Grants.

 

(a)                                   Commercialization
License.

 

(i)                                     License
to Centocor  Subject to the terms and
conditions of this Agreement, ImmunoGen hereby grants to Centocor an exclusive,
royalty-bearing license, including the right to grant sublicenses as described
in Section 2.1(a)(ii) below, under the Licensed Patent Rights and Licensed
Technology and ImmunoGen’s interest in Improvements, to Develop, have Developed,
make, have made, use, have used, sell, have sold, offer for sale, import, have
imported, export and have exported Licensed Products in the Field in the
Territory.

 

(ii)                                  Right
to Sublicense.  Centocor shall have
the right freely to grant sublicenses to all or any portion of its rights under
the license rights granted pursuant to Section 2.1(a)(i) hereof to any
Third Party; provided, however, that (1) ImmunoGen shall be
notified in writing of each such sublicense, (2) any and all sublicenses shall
be consistent with the terms and conditions of this Agreement, and (3) Centocor
shall remain obligated for the payment to ImmunoGen of all of its payment
obligations hereunder, including, without limitation, the payment of any
milestones and royalties described in Section 5 hereof.

 

(b)                                  Research
Licenses.

 

(i)                                     Research
License to Centocor  Subject
to the terms and conditions of this Agreement, during the Term of this
Agreement, ImmunoGen hereby grants to Centocor a fully paid-up, non-exclusive,
royalty-free, worldwide license, without the right to grant sublicenses, under
the Licensed Technology and Licensed Patent Rights and ImmunoGen’s interest in
any Improvements, for the sole purpose of conducting the activities it is
required to perform as part of the Research Program.

 

(ii)                                  Research
License to ImmunoGen.  Subject to the terms and conditions of this
Agreement, during the Term of this Agreement, Centocor hereby grants to
ImmunoGen a fully paid-up, non-exclusive, royalty-free, worldwide license,
without the right to grant sublicenses, under the Centocor Background
Technology and Centocor Patent Rights and Centocor’s interest in any
Improvements, Centocor Program Technology and Joint Program Technology, for the
sole purpose of conducting the activities it is required to perform as part of
the Research Program.

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

14

 

2.2                               Retained Rights and Covenants.

 

(a)                                   Retained
Rights.  Subject to the other terms
of this Agreement (including, without limitation, Section 2.2(b)),
ImmunoGen retains the right to use the Licensed Technology and its interest in
any Improvements and practice the Licensed Patent Rights (a) to perform its
obligations under this Agreement (including without limitation its obligation
to manufacture Preclinical Materials and Clinical Materials in accordance with Section 4
of this Agreement) (b) to develop, have developed, make, have made, use, have
used, sell, have sold, offer for sale, import, have imported, export and have
exported any product that is not a Licensed Product, and (c) for any and all
uses outside of the Field.

 

(b)                                  Covenants.  Notwithstanding anything to the contrary
contained in Section 2.2(a) or 2.3 of this Agreement, ImmunoGen hereby
agrees during the Term of this Agreement, that it shall not grant to any Third
Party any license or other right under any Patent Rights or Technology
Controlled by ImmunoGen to develop, have developed, commercialize, have
commercialized, make or have made any product containing a conjugate of a MAY
Compound to an Antibody which selectively and specifically binds with
[**************************].

 

2.3                               Improvement License to
ImmunoGen.  Centocor hereby grants to ImmunoGen a
non-exclusive, fully paid, irrevocable, royalty-free license, including the
right to grant sublicenses, under Centocor’s interest in Improvements
Controlled by Centocor (a) to manufacture Clinical Materials or Preclinical
Materials pursuant to the terms of this Agreement, and/or each applicable
Supply Agreement (b) to develop, make, have made, use, sell, have sold, offer
for sale, import, have imported, export and have exported any product that is
not a Licensed Product, and (c) to otherwise exploit such Improvements for all
uses outside of the Field.

 

3.                                      RESEARCH PROGRAM; DEVELOPMENT AND COMMERCIALIZATION

OF LICENSED PRODUCTS.

 

3.1                               Research Program.

 

(a)                                   Implementation of
Research Program.  Promptly following the
execution of this Agreement, the Parties shall cooperate in conducting the
Research Program as described

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

15

 

in the Research
Plan in Appendix 3.1 attached hereto. The Research Program shall be designed to
facilitate the selection of the appropriate [************************]
Antibodies and MAY Compounds to be used in preparing
[*********************]-MAY Conjugates and the conduct of initial research with respect to the
[*********************]-MAY Conjugates. The Research Program shall be conducted
pursuant to a Research Budget agreed to by the Parties.  The Parties may, by mutual agreement, make
adjustments in the Research Plan and Research Budget from time to time during
the Term of this Agreement.  Each Party
undertakes that the activities assigned to it in a Research Plan shall be
conducted diligently and in good scientific manner in accordance with accepted
laboratory practices and in compliance with any and all laws, regulations and
bioethical conventions applicable to the jurisdiction in which those activities
take place.

 

(b)                                  Collaborative
Efforts and Reports.  The Parties
agree that the successful execution of the Research Program will require the
collaborative use of both Parties’ areas of expertise.  The Parties shall keep the Collaboration
Committee and each other fully informed about the status of the Research
Program.  Scientists at ImmunoGen and
Centocor shall cooperate in the performance of the Research Program and,
subject to any confidentiality obligations to Third Parties, shall exchange
information and materials in a mutually acceptable secure manner as necessary
to carry out the Research Program, but subject to the provisions of Section 6
hereof.  The Parties expect that such
exchange of information and materials may involve short-term on-site visits by
scientists of each Party to the facilities of the other Party.

 

(c)                                   Additional
Obligations of ImmunoGen.  Subject to the other terms of this Agreement,
ImmunoGen may, [******************************], conduct such additional
research activities, as ImmunoGen, in its sole discretion, are necessary as
useful for the Development of Licensed Products.  Without limiting the generality of the
foregoing, ImmunoGen may from time to time, provide Centocor technical
assistance within ImmunoGen’s area of expertise (or its subcontractors)
concerning the Development of Licensed Products, provided that such technical
assistance and expertise is within the scope of the Licensed Technology and/or
Licensed Patent Rights covered under this Agreement.  Such technical

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

16

 

assistance and expertise shall include, but not be limited to, visits by ImmunoGen
personnel to Centocor and visits by Centocor Personnel to ImmunoGen (or its
subcontractors), at Centocor’s expense, at such times and for such periods of
time as may be reasonably acceptable to the Parties.

 

(d)                                  Supply
of Proprietary Materials.  From time
to time during the Research Program Term, either Party (the “transferring Party”)
may supply the other Party (the “recipient Party”) with its Proprietary
Materials for use in the Research Program. 
In connection therewith, the recipient Party hereby agrees that (i) it
shall not use Proprietary Materials for any purpose other than exercising any
rights granted to it or reserved by it hereunder; (ii) it shall use the
Proprietary Materials only in compliance with all applicable, federal, state,
and local laws and regulations; (iii) it shall not transfer any Proprietary
Materials to any Third Party without the prior written consent of the
transferring Party, except as expressly permitted hereby; (iv) the transferring
Party shall retain full ownership of all such Proprietary Materials; and (v)
upon the expiration or termination of this Agreement, the recipient Party shall
at the instruction of the transferring Party either destroy or return any
Proprietary Materials which are not the subject of the grant of a continuing
license hereunder.

 

3.2                               Development and
Commercialization.

 

(a)                                   Responsibility.  Subject to Section 3.3 of
this Agreement, on and after the Effective Date, Centocor shall have sole
control and authority over the Development and Commercialization of Licensed
Products in the Field in the Territory, including, without limitation, (i) the
conduct of all research and pre-clinical Development activities (including the
assessment of alternative designs for the [**********************]-MAY Conjugates,
the selection of the final [************************] Antibodies and MAY
Compounds to be used in the [*********************]-MAY Conjugates and the
selection of the [***********************]-MAY Conjugates to be Developed as
Licensed Products, all preclinical and IND-enabling studies, including
toxicology testing, any pharmaceutical development work on formulations or
process development relating to any such Licensed Products), (ii) all
activities related to human clinical trials, (iii) subject to Section 4 of
this

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

17

 

Agreement, all activities relating to the manufacture and supply of
[***********************] Antibodies, MAY Compounds and Licensed Products, to
the extent such activities relate to the Development and Commercialization of
Licensed Products (including all required process development and scale up work
with respect thereto), (iv) all Commercialization activities relating to any
Licensed Product, and (v) all activities relating to any regulatory filings, registrations,
applications and Regulatory Approvals relating to any of the foregoing
(including any INDs or foreign equivalents, any manufacturing facility
validation and/or licensure, any Drug Approval Applications and any other
Regulatory Approvals).  Except as
described in the next sentence, Centocor shall own all Technology arising from
any such activities under this Agreement, including, without limitation, all
regulatory filings, registrations, applications and Regulatory Approvals
relating to Licensed Products (including any INDs or foreign equivalents, any
Drug Approval Applications and any other Regulatory Approvals), and all of the
foregoing Technology and filings, registrations and applications shall be
considered Confidential Information solely owned by Centocor.  Notwithstanding the foregoing, ImmunoGen
shall own all Technology arising from ImmunoGen’s activities relating to the
manufacture and supply of MAY Compounds to Centocor and all of the foregoing
Technology shall be considered Confidential Information solely owned by
ImmunoGen.  Notwithstanding anything to
the contrary in this Agreement, (i) all activities relating to Development and
Commercialization of Licensed Products under this Agreement shall be undertaken
at Centocor’s sole cost and expense, except as otherwise expressly provided in
this Agreement, (ii) all business decisions, including, but not limited
to, the design, sale, price and promotion of Licensed Products under this
Agreement and the decision whether to market any particular Licensed Product
shall be within the sole discretion of Centocor, (iii) any marketing of a
Licensed Product in one market or country shall not obligate Centocor to market
said Licensed Product in any other market or country and (iv) Centocor makes no
warranty or representation that the marketing of any Licensed Product shall be
the exclusive means by which Centocor will participate in the Field to which
the Licensed Product relates.

 

(b)                                  Due Diligence.  Centocor will use commercially
reasonable efforts to

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

18

 

Develop and Commercialize Licensed Products, and to undertake
investigations and actions required to obtain appropriate Regulatory Approvals
necessary to market Licensed Products, in the Field and in the Territory, such commercially reasonable efforts to be
in accordance with the efforts and resources Centocor would use for a compound
owned by it or to which it has rights, which is of similar market potential at
a similar stage in development as the applicable Licensed Product, taking into
account the proprietary position of the Licensed Product, the relative
potential safety and efficacy of the Licensed Product, the regulatory
requirements involved in its Development, Commercialization and Regulatory
Approval,  the cost of goods and availability of capacity to
manufacture and supply the Licensed Product at commercial scale, and other
relevant factors including, without limitation, technical, legal, scientific or
medical factors.  In determining whether Centocor
is using the efforts described in this Section 4.4 to Develop a Licensed
Product the Parties shall consider, among other things, whether such Licensed
Product is in Active Development.  “Active
Development” shall mean that at any given time Centocor shall be diligently
engaging in one or more of the following Development activities for a given
Licensed Product:
[*************************************************************] from the
[************************] or [****************************] for any
[********************************************************] being [*******] or
[***************] or [*******************************************************
**************************************************************] and
[*******************] or [********************] and [*****************] from a
[**********************] and [********************] within [******************]
to [********] any of the preceding activities. 
Notwithstanding the foregoing, Centocor shall not be considered to have
failed to meet its obligation to use such efforts or have a Licensed Product in
Active Development if such failure is due to the failure on the part of
ImmunoGen to provide Preclinical or Clinical Materials under Article 4
hereof.  In the event that Centocor fails
to use commercially reasonable efforts as required hereunder, then, ImmunoGen’s
sole remedy shall be the right, in its sole discretion to (i) terminate the
licenses granted under Section 2.1 this Agreement for breach under Section 8.2(b)
below (including the notice and cure provisions

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

19

 

therein) or (ii) convert the licenses granted under Section 2.1 of
this Agreement from exclusive licenses to non-exclusive licenses, in either
case only as such licenses apply to such Licensed Product in such country,
which termination or conversion, as the case may be, shall be effective upon
expiration of the cure period specified in 8.2(b) below provided that such
failure remains uncured upon such expiration.

 

3.3                               Updates and Reports;
Notification of Milestones; Exchange of Adverse Event Information.

 

(a)                                   Updates and Reports.  Centocor
shall keep ImmunoGen informed of the progress of Centocor’s efforts to Develop
and Commercialize Licensed Products in the Field in the Territory by providing
ImmunoGen with brief written reports no less frequently than on each
anniversary of the Effective Date during the Term of this Agreement (commencing
with the first anniversary of the Effective Date) which shall summarize
Centocor’s efforts to Develop and Commercialize such Licensed Products,
identify the Drug Approval Applications that Centocor and its Sublicensees have
filed, sought or obtained in the prior twelve (12)-month period, and any they
reasonably expect to make, seek or attempt to obtain in the following twelve
(12)-month period.  The Parties agree
that the minutes of the Collaboration Committee meetings may serve as reports
hereunder, to the extent such minutes adequately address the above issues.

 

(b)                                  Notification
of Milestone Achievement.  Centocor shall provide ImmunoGen with prompt
written notice of the occurrence of any event giving rise to an obligation to
make a milestone payment to ImmunoGen under Section 5.1.2, which shall in
any event be no later than [***********] days after the occurrence of such event,
and shall provide ImmunoGen with prompt written notice of the occurrence of the
First Commercial Sale of any Licensed Product. 
In the event that, notwithstanding the fact that Centocor has not given
any such notice, ImmunoGen believes any such milestone event has occurred, it
shall so notify Centocor in writing, and shall provide to Centocor the data and
information demonstrating that the conditions for payment have been
achieved.  Within [***] ([***]) days of
its receipt of such notice, the Parties shall meet to review the data and
information and shall agree in good faith whether or not the conditions for
payment have been achieved.

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

20

 

(c)                                   Adverse Events.  As the owner of all regulatory
approvals, Centocor will be primarily responsible for Adverse Event, safety and
pharmacovigilence reporting on all Licensed Products.  To the extent that it may apply to a Licensed
Product, ImmunoGen agrees to provide Centocor with Adverse Event and product
complaint information relating to any product containing any MAY Compound that
is compiled and prepared by ImmunoGen or any Third Party in the normal course
of business in connection with the development, commercialization or sale of
any such product, in accordance with procedures that shall be agreed to by the
Parties based, in general, on Schedule D attached hereto (it being
the understanding of the Parties that such Schedule D is included
as an example only and shall not be binding upon the Parties); provided,
however, that the foregoing shall not require ImmunoGen to violate any
agreements with or confidentiality obligations owed to any Third Party.  In addition, Centocor agrees to provide
ImmunoGen with agreed upon Adverse Event information and product complaint
information relating to Licensed Products as compiled and prepared by Centocor
in the normal course of business in connection with the Development or
Commercialization of any Licensed Product, within time frames consistent with
reporting obligations under applicable laws and regulations in accordance with
procedures that shall be agreed to by the Parties based, in general, on Schedule D
attached hereto (it being the understanding of the Parties that such Schedule D
is included as an example only and shall not be binding upon the Parties).  Centocor shall provide its Adverse Event and
product complaint information hereunder to ImmunoGen’s designated
representative, who shall be its Chief Regulatory Officer unless ImmunoGen
otherwise notifies Centocor.  ImmunoGen
shall provide its Adverse Event and product complaint information hereunder to
Centocor’s designated representative identified on Schedule D
unless Centocor otherwise notifies ImmunoGen.

 

(d)                                  Correspondence for Licensed Products.  To the
extent reasonably practicable and subject to any Third Party confidentiality
obligations, Centocor shall provide ImmunoGen with copies of any material
documents or correspondence pertaining to ImmunoGen’s manufacture of
Preclinical Materials, Clinical Materials or any Licensed Product and prepared
for submission to the FDA and any material documents or other correspondence

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

21

 

received from the FDA pertaining to ImmunoGen’s manufacture of
Preclinical Materials, Clinical Materials or any Licensed Product.  ImmunoGen shall complete its review within
[********] days after receipt of the proposed submission. When requested in
writing, ImmunoGen shall provide reasonable assistance to Centocor in obtaining
Regulatory Approvals for Licensed Product. 
Notwithstanding the foregoing, Centocor shall have the sole
responsibility for, and ImmunoGen agrees that Centocor shall be the sole owner
of, any Regulatory Approval for the Licensed Product.

 

(e)                                   Confidential Information.  All
reports, updates, Adverse Event, product complaint and other information
provided by the disclosing Party to the receiving Party under this Agreement
(including under this Section 3.3), shall be considered Confidential
Information of the disclosing Party, subject to the terms of Section 6.

 

3.4                               Collaboration Committee.

 

(a)                                   Mandate and Establishment of Committee.  Promptly
after the Effective Date, the Parties shall form a Collaboration Committee to
serve as a forum for coordination and communication between the Parties with
respect to the Research Program and/or the development of manufacturing
processes applicable to any MAY Compound or Licensed Product covered by this
Agreement (including, without limitation, all process science and process
development work, formulation work, and quality control/assurance work
hereunder), and to assist Centocor in its exercise of its rights to make or
have made Licensed Products under this Agreement.  Within thirty (30) days after the Effective
Date, the Parties shall each nominate an equal number of representatives (which
shall be no less than two (2) each) for membership on the Collaboration
Committee.  Each Party may change its
representative(s) as it deems appropriate by notice to the other Party.

 

(b)                                  Chair of Committee; Meetings.  The
chair of the Collaboration Committee shall be one of the Centocor
representatives on the Collaboration Committee, as designated by Centocor.  The Collaboration Committee shall meet on a
semi-annual basis or other schedule agreed upon by the Parties, unless at
least thirty (30) days in advance of any meeting the chair of the Collaboration
Committee determines that there is no need for a meeting.  In such instance,

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

22

 

the next Collaboration Committee meeting shall also be scheduled as
agreed upon by the Parties.  The location
of meetings of the Collaboration Committee shall alternate between ImmunoGen’s
offices and Centocor’s offices in Cambridge, Massachusetts and
Malvern/Radnor/Horsham/ Chesterbrook/Springhouse, Pennsylvania, respectively,
unless otherwise agreed by the Parties. As agreed upon by the Parties,
Collaboration Committee meetings may be face-to-face or may be conducted
through teleconferences and/or videoconferences.  In addition to its Collaboration Committee
representatives, each Party shall be entitled to have other employees attend
such meetings to present and participate, though not in a decision-making
capacity.  Each Party shall bear its own
costs and expenses, including travel and lodging expense, that may be incurred
by Collaboration Committee representatives or other attendees at Collaboration
Committee meetings, as a result of such meetings hereunder.  Minutes of each Collaboration Committee
meeting will be transcribed and issued to members of the Collaboration
Committee by the chair within thirty (30) days after each meeting, and such
minutes shall be reviewed and modified as mutually required to obtain approval
of such minutes promptly thereafter.

 

4.                                      SUPPLY AND MANUFACTURING OBLIGATIONS

 

4.1                               Supply of Preclinical Materials, Clinical
Materials and Licensed Product. 
Centocor shall be responsible, at its sole cost, for manufacturing or
having manufactured through Third Party contract manufacturers, any materials
(including without limitation, all [**********************] Antibodies, MAY
Compounds and [******************]-MAY Conjugates) as may be required for all
preclinical and clinical studies necessary to obtain Regulatory Approval of
Licensed Products and any materials and/or quantities of each Licensed Product
as may required for all preclinical and clinical studies applicable to such
Licensed Product and for Commercialization of such Licensed Product.

 

4.2                               Supply
of Preclinical Materials by ImmunoGen. 
Notwithstanding anything to the contrary in Section 4.1, during the
Term of this Agreement, Centocor may request ImmunoGen to supply Centocor with
such quantities of Preclinical Materials as may be reasonably required by
Centocor in order to conduct all pre-clinical Development activities

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

23

 

(including,
without limitation, toxicology testing) relating to Licensed Products.  Centocor shall order all amounts of
Preclinical Materials, and ImmunoGen shall deliver all such ordered amounts, in
accordance with advance ordering timeframes and delivery timeframes and
specifications to be agreed upon by the Parties.  To the extent Centocor requests ImmunoGen to
manufacture any [*********************]-MAY Conjugate, Centocor shall supply
ImmunoGen with quantities of [***************************] Antibodies
sufficient to enable ImmunoGen to produce such [**************************]-MAY
Conjugate.  ImmunoGen shall use
commercially reasonable efforts to deliver to Centocor such amounts of
Preclinical Materials as are ordered by Centocor in accordance with the
foregoing (including such agreed upon timeframes) in a timely manner; provided,
that, to the extent such Preclinical Materials are
[************************]-MAY Conjugates, ImmunoGen’s obligations shall be
contingent on ImmunoGen’s receipt of the required quantities of
[************************] Antibodies from Centocor.  In connection with any ordering of
Preclinical Materials by Centocor, ImmunoGen shall provide Centocor promptly
with ImmunoGen’s good faith estimate of the Cost for manufacture and supply of
such Preclinical Materials.  ImmunoGen’s
price to supply Preclinical Materials to Centocor shall equal
[*************************] for such Preclinical Materials.  In connection with such supply, Centocor
hereby agrees that (a) it shall not use the Preclinical Materials in any human
subject, (b) it shall use the Preclinical Materials in compliance with all
applicable federal, state and local laws and regulations, and (c) it (as a
matter of contract between itself and ImmunoGen) shall assume all liability for
damages that may arise from the use, storage and disposal of any Preclinical
Materials.  Centocor shall be entitled to
transfer Preclinical Materials to any Third Party under terms obligating such
Third Party not to transfer or use such Preclinical Materials except in
compliance with the foregoing clauses (a) and (b) of this Section 4.2.

 

4.3                               Supply
of Clinical Materials by ImmunoGen.  If, during the Term of
this Agreement, Centocor requests in writing that ImmunoGen supply Centocor
with such quantities of Clinical Materials as may be reasonably required by
Centocor in order to conduct human clinical trials of such Clinical Materials
through the completion of non-pivotal Phase II Clinical

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

24

 

Trials for such
Clinical Materials, ImmunoGen will use commercially reasonable efforts to
supply Centocor with such Clinical Materials. 
If, during the Term of this Agreement, Centocor requests in writing that
ImmunoGen supply it with Clinical Materials in connection with the conduct of
Pivotal Clinical Trials, ImmunoGen will supply Centocor with such Clinical
Materials only to the extent ImmunoGen has the capability to do so at the time
of Centocor’s request.  In either event,
the Parties shall share information concerning specifications, forecasting and
capacity requirements in order to adequately plan for the manufacture of such
Clinical Materials. To the extent Centocor requests ImmunoGen to manufacture
Clinical Materials as provided in the foregoing sentences, ImmunoGen and Centocor
shall enter into a separate supply and quality agreements detailing the terms
of supply for any Clinical Materials that ImmunoGen is so requested to supply
to Centocor for the purpose of conducting clinical trials, which supply
agreement shall include, without limitation, the terms set forth on Schedule B
attached hereto and the remainder of this Section 4.3 (the “Supply
Agreement”).  Subject to the foregoing,
Centocor shall order all amounts of Clinical Materials, and ImmunoGen shall
deliver all such ordered amounts, in accordance with forecasting parameters,
advance ordering timeframes and delivery timeframes to be agreed upon by the
Parties in the Supply Agreement.  The
Supply Agreement further shall provide that ImmunoGen shall use commercially reasonable
efforts to deliver such amounts of Clinical Materials ordered in accordance
with the foregoing (including such agreed upon timeframes) in a timely manner; provided,
that, ImmunoGen’s obligations shall be contingent on ImmunoGen’s receipt
of the required quantities of [************************] Antibodies from
Centocor.  In connection with any
ordering of Clinical Materials by Centocor, ImmunoGen shall provide Centocor
promptly with ImmunoGen’s good faith estimate of the Cost for manufacture and supply
of such Clinical Materials.  The Supply
Agreement shall provide that ImmunoGen’s price to supply Clinical Materials to
Centocor shall equal [************************************] for such Clinical
Materials.  Centocor hereby agrees that
(a) it shall use the Clinical Materials in compliance with all applicable
federal, state and local laws, and (b) it (as a matter of contract between
itself and ImmunoGen) shall assume all liability for damages that may arise
from the

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

25

 

use, storage and
disposal of such Clinical Materials. 
Centocor shall be entitled to transfer Clinical Materials to any Third
Party under terms obligating such Third Party not to transfer or use such
Clinical Materials except in compliance with the foregoing clause (a) of this Section 4.3.

 

4.4                               Purchase
of Dedicated Equipment.  If, during the Term
of this Agreement, ImmunoGen determines in good faith that it is necessary or
advisable to purchase Dedicated Equipment in order to perform any of its
obligations to manufacture Preclinical Materials and Clinical Materials under
Sections 4.2 or 4.3 of this Agreement, then ImmunoGen shall provide Centocor
with written notice of such determination, along with the estimated price for
such purchase and quality parameters for the Dedicated Equipment, for Centocor’s
approval of such price and features. 
Promptly after the consummation of such purchase, assuming that Centocor
has provided its approval hereunder, ImmunoGen shall provide Centocor with a
copy of the invoice or invoices reflecting such purchase, and Centocor shall
reimburse ImmunoGen for the purchase of all such approved Dedicated Equipment
hereunder within [****************] of its receipt of such invoice from
ImmunoGen; provided, however, that no costs reimbursed by
Centocor hereunder (or depreciation of such purchased equipment or instruments)
shall be included within the calculation of any Costs under this
Agreement.  Centocor shall have title and
ownership of all such Dedicated Equipment purchased pursuant to this Section 4.4,
and shall have the right to reclaim or retain possession of such Dedicated
Equipment at its expense upon reasonable notice at such time as it is no longer
required for use by ImmunoGen to carry out this Agreement.  Notwithstanding the foregoing, the purchase
of items including, but not limited to, routine lab equipment, biological
materials, products and reagents reasonably required by ImmunoGen to conduct
the Research Program shall be included in the Research Budget and shall be ImmunoGen’s
obligation and responsibility.

 

4.5                               Process
Development Activities.  To the
extent that Centocor requests that ImmunoGen manufacture Preclinical Materials
or Clinical Materials as described in this Section 4, ImmunoGen shall
conduct such process development activities as the Parties agree are necessary
to produce the quantities of Preclinical Materials or Clinical Materials so
ordered,

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

26

 

which process
development activities shall be included within the calculation of Cost to be
paid by Centocor pursuant to Sections 4.2 and/or 4.3 of this Agreement and/or
the Supply Agreement.

 

4.6                               Audit Rights

 

4.6.1                     Audit
of Records.  ImmunoGen will maintain
complete and accurate records which are relevant to its supply of Preclinical
Materials as described in this Section 4, for subsequent use in GLP
toxicology studies, including records concerning the Costs, purchase of
Dedicated Equipment and Process Development Activities.  ImmunoGen shall maintain all records relating
thereto in good order.  At the request of
Centocor, upon at least [***********] business days’ prior written notice, but
no more often than once per year, and at its sole expense (except as otherwise
provided herein), ImmunoGen shall permit an independent certified public
accountant reasonably selected by Centocor and reasonably acceptable to
ImmunoGen to inspect (during regular business hours) the relevant records
required to be maintained by ImmunoGen under this Section 4.5 (including
records pertaining to ImmunoGen’s compliance with the Policy described in Section 9.1).  At Centocor’s request, the accountant shall
be entitled to audit the then-preceding [***********] years of ImmunoGen’s
records for purposes of verifying ImmunoGen’s records concerning Costs and its
purchase of Dedicated Equipment.  To the
extent requested by ImmunoGen the accountant shall enter into a confidentiality
agreement with both Parties substantially similar to the provisions of Section 6
limiting the disclosure and use of such information by such accountant to
authorized representatives of the Parties and the purposes germane to this Section 4.5.  The results of any such audit shall be made
available to both Parties and shall be binding on both Parties.  Centocor agrees to treat the results of any
such accountant’s review of ImmunoGen’s records under this Section 4.5 as
Confidential Information of ImmunoGen subject to the terms of Section 6.  If any such audit reveals an overcharge to
Centocor attributable to a deficiency in the calculation of Costs, or the
purchase of Dedicated Equipment, ImmunoGen shall promptly pay Centocor the
amount of the overpayment (plus interest thereon at the rate provided in Section 5.7
above), and if such overpayment is by [****] percent [*******] or more, ImmunoGen
shall pay the costs and expenses of the audit.

 

4.6.2                     Audit
of Facility.  ImmunoGen agrees that,
to the extent ImmunoGen

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

27

 

manufactures any
Preclinical Materials under this Section 4 for subsequent use in GLP
toxicology studies, Centocor shall have the right to audit, under appropriate
confidentiality provisions, during normal business hours and not more often
than once per year, the facilities employed and the documentation utilized by
ImmunoGen or its contractors or subcontractors for manufacturing Preclinical
Materials.  Centocor may appoint a Third
Party reasonably acceptable to ImmunoGen to perform such audit; provided
Centocor hereby warrants that such Third Party will abide by secrecy and
non-use obligations no less stringent than those contained in this Agreement
and, to the extent requested by ImmunoGen, Cenotocor to provide ImmunoGen with
a copy of the confidentiality agreement evidencing such secrecy and non-use
obligations.  All such audits shall be at
Centocor’s sole cost and expense. 
Centocor will notify ImmunoGen at least [************] business days in
advance of such an audit by Centocor and [***********] business days in advance
of such an audit by a Third Party. 
ImmunoGen shall use commercially reasonable efforts to remedy any
material deficiencies identified in such audit as soon as possible.  In the event that, subject to the obligation
of ImmunoGen to use commercially reasonable efforts, such deficiencies cannot
be remedied within [**************] business days, ImmunoGen shall so notify
Centocor and Centocor shall, as its sole remedy, be entitled to terminate this
Agreement in accordance with Section 8.2(b).  ImmunoGen acknowledges that the provisions of
this Section 4.6.2 granting Centocor certain audit rights shall in no way
relieve ImmunoGen of any of its obligations under this Agreement, nor shall
such provisions require Centocor to conduct any such audits.

 

4.7                               Debarrment.   ImmunoGen
shall not employ, contract with or retain any person, directly or indirectly,
to perform any services under this Section 4 if such person is debarred by
the FDA under 21 U.S.C. § 335a. Upon written request from Centocor,
ImmunoGen shall, within [***********] days, provide written confirmation that
it has complied with the foregoing obligation.

 

4.8                               Manufacturing
Licenses and Governmental Audits.   ImmunoGen shall obtain and maintain at its sole
expense all licenses and registrations appropriate and necessary in connection
with any manufacturing activities it agrees to conduct under this Section 4
at its

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

28

 

manufacturing facility.  To the extent ImmunoGen undertakes any
manufacturing obligations under this Section 4, ImmunoGen shall
notify Centocor of any inspections or audits of ImmunoGen’s facilities
conducted by governmental authorities (such as the FDA and equivalent European
regulatory authorities) affecting or which could reasonably be expected to
affect the manufacture of Licensed Product. All of ImmunoGen’s expenses
(including internal costs such as, without limitation, labor costs) associated
with such audits or inspections shall be borne by ImmunoGen.

 

5.                                      PAYMENTS AND ROYALTIES

 

5.1                               Milestone Payments for Licensed Products.

 

5.1.1                     Upfront Fee.  In consideration of the grant of the license
described in Section 2.1 hereof, Centocor hereby agrees to pay ImmunoGen
an upfront fee (the “Upfront Fee”) in the amount of $1,000,000 payable in
immediately available funds within three (3) business days of the Effective
Date, which Upfront Fee shall be non-refundable and non-creditable.

 

5.1.2                     Milestones.  In further consideration of the grant of the
license by ImmunoGen hereunder, and subject to the other terms of this
Agreement, Centocor will make the following payments to ImmunoGen within
[**********] days after the first occurrence of each of the milestones set
forth below:

 

	
  Milestone

  	
   

  	
  Milestone Payment

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [********] for a [********]

  	
   

  	
  $

  	
  [********]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [********] of the [********]

  	
   

  	
   

  	
   

  
	
  [********] as defined in [********]

  	
   

  	
  $

  	
  [********]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [*************]
  of [********************]

  	
   

  	
   

  	
   

  
	
  [********] in
  [********] for a [**************]

  	
   

  	
  $

  	
  [********]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [********] of
  [****************]

  	
   

  	
   

  	
   

  
	
  ([********]) for
  the [*************] of a

  	
   

  	
   

  	
   

  
	
  [*****************]

  	
   

  	
  $

  	
  [********]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [************]
  of [*******************]

  	
   

  	
   

  	
   

  
	
  ([********] or
  [********]) for the[************] of a

  	
   

  	
   

  	
   

  
	
  [********]

  	
   

  	
  $

  	
  [********]

  	
   

  

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

29

 

	
  [********] or
  [********] for the [********] of a

  	
   

  	
   

  	
   

  
	
  [*******************]

  	
   

  	
  $

  	
  [********]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [********] or
  [********] for the [********] of

  	
   

  	
   

  	
   

  
	
  a
  [****************]

  	
   

  	
  $

  	
  [********]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [********] of
  [****] or [********] or [************]

  	
   

  	
   

  	
   

  
	
  by the
  [********] for the [********] of a [********]

  	
   

  	
  $

  	
  [********]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [********] of
  [********] or [********] or [********]

  	
   

  	
   

  	
   

  
	
  for the
  [********] of [********]

  	
   

  	
  $

  	
  [********]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [********] of an
  [********] or [********]

  	
   

  	
   

  	
   

  
	
  [********] in
  any [********]

  	
   

  	
   

  	
   

  
	
  for the
  [********] of a [**************]

  	
   

  	
  $

  	
  [********]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [********] of an
  [*****] or [***********] in

  	
   

  	
   

  	
   

  
	
  any
  [*************] for the [********]

  	
   

  	
   

  	
   

  
	
  [********] of a
  [***************]

  	
   

  	
  $

  	
  [********]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  [********] of a
  [***************] for the

  	
   

  	
   

  	
   

  
	
  [********] of a
  [***********] in [********]

  	
   

  	
  $

  	
  [********]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [********] of a
  [***********************] for

  	
   

  	
   

  	
   

  
	
  the
  [*************] of a [********] in [********]

  	
   

  	
  $

  	
  [********]

  	
   

  

 

It is hereby acknowledged and agreed that (a) any
milestone payment shall be made only once, with respect to the first
achievement of the relevant milestone for given indication of a Licensed
Product regardless of how many times that particular indication of a Licensed
Product achieves such milestone under this Agreement and (b) if one or more of
the above milestone payments has been paid with respect to a given Licensed Product
and the Development or Commercialization of the Licensed Product is
subsequently discontinued by Centocor, Centocor shall be entitled to credit any
milestone payment made with respect to such discontinued Licensed Product
against any milestone payments that may be due and payable for the next
Licensed Product to achieve such milestone. 
Except as provided in the preceding sentence, all milestone payments
shall be nonrefundable and noncreditable. 
Centocor shall notify ImmunoGen of the achievement of each

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

30

 

milestone hereunder for each Licensed Product as
provided in Section 3.3(b) above.

 

5.2                               Research Funding.  In consideration of the performance by
ImmunoGen of the Research Program, Centocor will pay ImmunoGen for all FTEs
used by ImmunoGen in such Research Program and pursuant to the Research Budget,
as described in the Research Plan and/or agreed to by the Parties, at a rate
per FTE equal to the FTE Rate.  From time
to time after the Effective Date, the Parties shall agree in writing upon the
number of FTEs required of ImmunoGen for agreed-upon portions of the Research
Program and Centocor shall pay the FTE Cost for the FTEs reflected in such
written agreement.  If, at any time
during the Term of this Agreement, ImmunoGen determines that the actual number
of FTEs for a particular period agreed to by the Parties is [******] to
[******] by [********] the FTE number set forth in such written agreement for
such period, ImmunoGen shall give Centocor prompt written notice of same and
the Parties shall discuss in good faith whether to [********] the [***] of such
[********] or to [********] the [********] to be [********], such that such
[************] are [********] ImmunoGen
will maintain complete and accurate records which are relevant to its
expenditure of Research Program funding provided to it by Centocor pursuant to
this Article 5.3 as well as the purchase of any dedicated Equipment
pursuant to Section 4.4 hereof. At the request of
Centocor, upon at least [********] business days’ prior written notice, but no
more often than once per year, and at its sole expense (except as otherwise
provided herein), ImmunoGen shall permit an independent certified public
accountant reasonably selected by Centocor and reasonably acceptable to
ImmunoGen to inspect (during regular business hours) the relevant records
required to be maintained by ImmunoGen under this Section 5.2.  At Centocor’s request, the accountant shall
be entitled to audit the then-preceding [*****] years of ImmunoGen’s records
for purposes of verifying ImmunoGen’s records concerning FTEs. To the extent
requested by ImmunoGen, the accountant shall enter into a confidentiality
agreement with both Parties substantially similar to the provisions of Section 6
limiting the disclosure and use of such information by such accountant to
authorized representatives of the Parties and the purposes germane to this Section 5.2.  The results of any such audit shall be made
available to both Parties and shall be binding on both Parties.  Centocor agrees to treat the results of any
such

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

31

 

accountant’s
review of ImmunoGen’s records under this Section 5.2 as Confidential
Information of ImmunoGen subject to the terms of Section 6.  If any such audit reveals that the actual
FTEs expended by ImmunoGen are less than the amount of FTEs ImmunoGen indicated
was expended, ImmunoGen shall promptly pay Centocor the amount of overpayment
(plus interest thereon at the rate provided in Section 5.7 above) made by
Centocor with respect to such FTEs and if any such audit reveals that the
actual FTEs expended by ImmunoGen was in excess of the amount of FTEs ImmunoGen
indicated was expended, Centocor shall promptly pay ImmunoGen the amount of
underpayment (plus interest thereon at the rate provided in Section 5.7
above) with respect to such FTEs.

 

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

 

5.3.1                     Royalty
Payments.  In further
consideration of the grant of the license by ImmunoGen hereunder, and subject
to the other terms of this Agreement, commencing on the first date of First
Commercial Sale of Licensed Products in any country or jurisdiction in the
Territory, Centocor shall pay to ImmunoGen the following royalties based on Net
Sales of all Licensed Products sold by Centocor and/or its Sublicensees which
would, but for the license granted herein, infringe a Valid Claim of the
Licensed Patent Rights or which utilizes the Licensed Technology, on an
incremental basis in each calendar year during the Term, at the following
rates:

 

	
  For
  Annual Worldwide Net Sales

  of Licensed Products

  	
   

  	
  Royalty Rate (% of Annual Net Sales)

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Above $[*], but
  less than $[********]

  	
   

  	
  [*]

  	
  %

  
	
   

  	
   

  	
   

  	
   

  
	
  $[********] and
  above, but less than $[********]

  	
   

  	
  [*]

  	
  %

  
	
   

  	
   

  	
   

  	
   

  
	
  $[********] and
  above, but less than $[********]

  	
   

  	
  [*]

  	
  %

  
	
   

  	
   

  	
   

  	
   

  
	
  $[********] and
  above

  	
   

  	
  [*]

  	
  %

  

 

5.3.2                     Third
Party Royalty Offset.  In the event that Centocor, in order to exploit the license
granted to it under Section 2.1 of this Agreement in any country in the
Territory, is required to and actually makes royalty payments to any Third
Party (“Third Party Payments”)
(a) to obtain a license to an issued patent or patents in the absence of which
the

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

32

 

MAY Compound
portion of a Licensed Product could not legally be developed, manufactured or
sold in such country and/or (b) to obtain a license to an issued patent or
patents specific to the Licensed Technology used by ImmunoGen to conjugate MAY
Compound to Antibodies, in the absence of which any of the Licensed Patent
Rights necessary to conjugate MAY Compound to an Antibody Controlled by
Centocor as part of a Licensed Product can not legally be practiced (as
evidenced, to the extent reasonably requested by ImmunoGen, by an opinion of
patent counsel), then royalties due to ImmunoGen for such Licensed Product may
be reduced by [********] ([***]%) of the amount of such Third Party Payments in
such country.  Notwithstanding the
following, any such reductions under this Section 5.3.2 shall in no event
reduce the royalty for such Licensed Product payable under Section 5.3.1
to less than [*]% of Net Sales in such country.

 

5.4                               One
Royalty.  Only one royalty,
calculated at the highest applicable royalty rate under this Section 5,
shall be payable to ImmunoGen hereunder for each sale of a Licensed Product.

 

5.5                               Royalty
Term.  Centocor shall pay
royalties with respect to each Licensed Product on a country-by-country and
Licensed Product-by-Licensed Product basis until the later of (a) [********]
years from the First Commercial Sale of such Licensed Product in such country
and (b) the expiration of the last to expire Valid Claim of the Licensed Patent
Rights covering the Licensed Product in such country.  Following such royalty term, Centocor shall
have a fully paid-up, irrevocable, freely transferable and sublicensable
license in such country under the relevant Licensed Patent Rights and Licensed
Technology, to Develop, have Developed, make, have made, use, have used, sell,
have sold, offer for sale, export, have exported, import and have imported such
Licensed Product in such country.

 

5.6                               Payment Terms.

 

(a)                                   Payment
of Milestones; Payment of Royalties; Royalty Reports.  Centocor shall make any milestone payments
owed to ImmunoGen hereunder in United States Dollars, using the wire transfer
provisions of Section 5.6(d) within [********] days of the occurrence of
the applicable milestone.  Centocor shall
make any royalty payments owed to ImmunoGen in 

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

33

 

United States Dollars,
quarterly within [******] days following the end of each calendar quarter for
which such royalties are deemed to occur (as provided in the next sentence),
using the wire transfer provisions of Section 5.6(d).  For purposes of determining when a sale of
any Licensed Product occurs under this Agreement, the sale shall be deemed to
occur on the earlier of (i) the date the Licensed Product is shipped or (ii)
the date of the invoice to the purchaser of the Licensed Product.  Each royalty payment shall be accompanied by
a report for each country in the Territory in which sales of Licensed Products
occurred in the calendar quarter covered by such statement, specifying:  the gross sales (if available) and Net Sales
in each country’s currency; the applicable royalty rate under this Agreement;
the royalties payable in each country’s currency, including an accounting of
deductions taken in the calculation of Net Sales; the applicable exchange rate
to convert from each country’s currency to United States Dollars under this Section 5.6;
and the royalties payable in United States Dollars.

 

(b)                                  Accounting.  All payments hereunder shall be made in the
United States in United States dollars. In the case of sales of any Licensed
Product outside the United States, royalty payments by Centocor to ImmunoGen
shall be converted to Dollars in accordance with Centocor’s current customary
and usual procedures for calculating same which are the following:  the rate of currency conversion shall be
calculated using a simple monthly period average of the end “spot rates”
provided by Brown Brothers Harriman, 59 Wall Street, NY, NY 10005, for each
quarter, or if such rate is not available, the spot rate as published by a
leading United States commercial bank for such accounting period.  Centocor hereby represents to ImmunoGen that
this method of conversion is consistent with Centocor’s current accounting
methods.  Centocor shall give ImmunoGen
prompt written notice of any changes to Centocor’s customary and usual
procedures for currency conversion, which shall only apply [********] days
after such notice has been delivered and provided that such changes continue to
maintain a set methodology for currency conversion.

 

(c)                                   Tax
Withholding; Restrictions on Payment.   All payments hereunder shall be made free and
clear of any taxes, duties, levies, fees or charges, except for withholding
taxes (to the extent applicable). 
Centocor shall make any applicable withholding payments due on

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

34

 

behalf of
ImmunoGen and shall promptly provide ImmunoGen with written documentation of
any such payment sufficient to satisfy the requirements of the United States
Internal Revenue Service relating to an application by ImmunoGen for a foreign
tax credit for such payment.  If by law,
regulations or fiscal policy of a particular country in the Territory,
remittance of royalties in United States Dollars is restricted or forbidden,
written notice thereof shall promptly be given to ImmunoGen, and payment of the
royalty shall be made by the deposit thereof in local currency to the credit of
ImmunoGen in a recognized banking institution designated by ImmunoGen by
written notice to Centocor.  When in any
country in the Territory the law or regulations prohibit both the transmittal
and the deposit of royalties on sales in such country, royalty payments shall
be suspended for as long a such prohibition is in effect and as soon as such
prohibition ceases to be in effect, all royalties that Centocor would have been
under an obligation to transmit or deposit but for the prohibition shall
forthwith be deposited or transmitted, to the extent allowable.

 

(d)                                  Wire
Transfers.  All payments hereunder
shall be made to ImmunoGen by bank wire transfer in immediately available funds
to the account designated by ImmunoGen by written notice to Centocor from time
to time.

 

5.7                               Overdue
Payments.  Subject to the other
terms of this Agreement, royalties or milestones not paid within the time
period set forth in this Section 5 shall bear interest at a rate equal to
[********] per month compounded monthly from the due date until paid in full,
provided that in no event shall such annual rate exceed the maximum interest
rate permitted by law in regard to such payments.  Such royalty or milestone payment when made
shall be accompanied by all interest so accrued.  Such interest and the payment and acceptance
thereof shall not negate or waive the right of ImmunoGen to any other remedy,
legal or equitable, to which it may be entitled because of the delinquency of
the payment.

 

5.8                               Records Retention; Audit.

 

(a)                                   Royalties.  Commencing as of the date of First Commercial
Sale of the first Licensed Product, Centocor and its Affiliates and
Sublicensees shall keep for at least [********] years from the end of the
calendar year to which they pertain complete and accurate

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

35

 

records of sales
by Centocor or its Affiliates or Sublicensees, as the case may be, of each
Licensed Product, in sufficient detail to allow the accuracy of the royalties
to be confirmed.

 

(b)                                  Audit.  Subject to the other terms of this Section 5.8(b),
at the request of ImmunoGen, upon at least [********] business days’ prior
written notice, but no more often than once per year, and at its sole expense
(except as otherwise provided herein), Centocor shall permit an independent
certified public accountant reasonably selected by ImmunoGen and reasonably
acceptable to Centocor to inspect (during regular business hours) the relevant
records required to be maintained by Centocor under Section 5.8(a).  At ImmunoGen’s request, the accountant shall
be entitled to audit the then-preceding [********] years of Centocor’s records
for purposes of verifying Centocor’s royalty calculations.  To the extent requested by Centocor the
accountant shall enter into a confidentiality agreement with both Parties
substantially similar to the provisions of Section 6 limiting the
disclosure and use of such information by such accountant to authorized
representatives of the Parties and the purposes germane to this Section 5.8.  Results of any such audit shall be made
available to both Parties and shall be binding on both Parties.  ImmunoGen agrees to treat the results of any
such accountant’s review of Centocor’s records under this Section 5.8 as
Confidential Information of Centocor subject to the terms of Section 6.  If any such audit reveals a deficiency in the
calculation of royalties resulting from any underpayment by Centocor, Centocor
shall promptly pay ImmunoGen the amount remaining to be paid (plus interest
thereon at a rate equal to the prime rate plus [********] percent (**%)), and
if such underpayment is by [*****] percent (**%) or more, Centocor shall pay
the costs and expenses of the audit.

 

6.                                      TREATMENT OF CONFIDENTIAL INFORMATION

 

6.1                               Confidential
Information.  ImmunoGen and Centocor each recognize that
the other Party’s Confidential Information constitutes highly valuable and
proprietary confidential information. 
During the term of this Agreement, and for a period of [********] years
after the receipt of any such Confidential Information from the disclosing
Party hereunder, whichever is longer, subject to the terms of this Section 6,
the receiving Party shall keep confidential and not

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

36

 

disclose (by
publication or otherwise) Confidential Information of the disclosing Party, and
shall not use, publish or otherwise disclose Confidential Information of the
disclosing Party for any purpose other than those purposes contemplated by this
Agreement.  Each receiving Party shall
take such action, and shall cause its Affiliates or sublicensees to take such
action, to preserve the confidentiality of the disclosing Party’s Confidential
Information as it would customarily take to preserve the confidentiality of its
own Confidential Information, using, in all such circumstances, not less than
reasonable care. Each receiving Party, upon the request of the disclosing
Party, will return all the Confidential Information disclosed or transferred to
it by the disclosing Party pursuant to this Agreement, including all copies and
extracts of documents and all manifestations in whatever form, within
[********] days of such request or, if earlier, the termination or expiration
of this Agreement; provided  however, that a receiving Party may retain
(a) any Confidential Information of the disclosing Party relating to any
license which expressly survives such termination and (b) one (1) copy of all
other Confidential Information in inactive archives solely for the purpose of
establishing the contents thereof.

 

6.2                               Permitted Disclosures; Publications.

 

(a)                                   Disclosures
to Certain Employees and Agents. 
Each receiving Party shall be entitled to disclose Confidential
Information of the disclosing Party to employees of the receiving Party,
provided that such employees are bound by obligations of confidentiality to the
receiving Party, and also to Affiliates, consultants, agents and Third Parties
for any purpose provided for in this Agreement, provided that any such
Affiliate, consultant, agent or other Third Party has first agreed to
confidentiality restrictions and obligations at least as protective as this Section 6,
in each case for any purpose contemplated by this Agreement (including as
reasonably necessary to exercise any rights or perform any obligations under
this Agreement).

 

(b)                                  Other
Permitted Disclosures. 
Notwithstanding the foregoing, Confidential Information of a disclosing
Party may be disclosed by the receiving Party to the extent such disclosure is
reasonably necessary for (i) filing or prosecuting patent applications or
maintaining patents, (ii) prosecuting or defending litigation, enforcing rights
and/or obligations under this Agreement, or (iii) complying with applicable
laws, regulations or court orders; provided, that, if

 

 

Portions of
this Exhibit were omitted and have been filed separately with the Secretary of
the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

37

 

a receiving Party
is required by applicable law, regulation or court order to make disclosure of
the disclosing Party’s Confidential Information, it will give reasonable
advance notice to the disclosing Party of the need for such disclosure and will
use its commercially reasonable efforts to secure confidential treatment (if
available) of such disclosing Party’s Confidential Information required to be
disclosed.

 

(c)                                   Review
of Publications.  Each receiving
Party shall consult with the disclosing Party prior to the submission of any
manuscript or abstract for publication if the publication will contain any
Confidential Information of the disclosing Party, unless the applicable laws
and regulations prohibit such consultation. 
Such consultation shall include providing a copy of the proposed
manuscript or abstract to the disclosing Party at least [********] days prior
to the proposed date of submission to a publisher, incorporating appropriate
changes proposed by the disclosing Party regarding its Confidential Information
into the manuscript or abstract submission and deleting all Confidential
Information of the disclosing Party as it may request; provided, however,
that the disclosing Party’s review hereunder shall be deemed completed at
the end of such [********] day period.

 

6.3                               Use of Names; Press Releases.

 

(a)                                   Use
of Names.  A Party may not use the
name of the other Party (or any trademarks or trade names of the other Party)
in any press release or any other publicity or advertising without the prior
written consent of the other Party.

 

(b)                                  Press
Releases.  Neither Party may issue a
press release or otherwise publicize or disclose any information related to
this Agreement or the terms or conditions hereof, without the prior written consent
of the other Party, which consent shall not be unreasonably withheld or
delayed; provided, however, that either Party may make such a
disclosure (a) to the extent required by law or by the requirements of any
nationally recognized securities exchange, quotation system or over-the-counter
market on which such Party has its securities listed or traded, or (b) to any
investors, prospective investors, lenders and other potential financing sources
who are obligated to keep such information confidential.  In
the event that such disclosure is required as aforesaid, the disclosing Party
shall make reasonable efforts to provide

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

38

 

the other Party
with notice beforehand and to coordinate with the other Party with respect to the
wording and timing of any such disclosure. 
The Parties shall mutually agree on the text of any press release
announcing the execution of this Agreement. 
Once any written text is approved for disclosure by both Parties as
provided herein, either Party may make subsequent or repeated public
disclosures of the contents thereof without the further approval of the other
Party.

 

6.4                               Integration;
Survival.  As to the subject
matter of this Agreement, this Section 6 supersedes any confidential
disclosure agreements between the Parties, including, without limitation, the
confidentiality provisions of the MTA, and of that certain Confidentiality
Agreement effective [********].  Any
confidential information of a Party under any such agreement shall be treated
as Confidential Information of such Party hereunder, subject to the terms of
this Section 6.  Section 6
shall survive termination or expiration of this Agreement.

 

7.                                      PROVISIONS CONCERNING THE FILING, PROSECUTION AND

MAINTENANCE
OF PATENT RIGHTS

 

7.1                               Ownership of Intellectual Property.

 

(a)                                   Solely-Owned
Technology.  ImmunoGen shall own (i)
the Licensed Patent Rights, the Licensed Technology and the ImmunoGen
Materials, (ii) all ImmunoGen Program Technology (whether or not patentable),
and (iii) all Improvements made during the course of and pursuant to activities
carried out under this Agreement solely by employees of or agents to or others
obligated to assign inventions to ImmunoGen. 
Centocor shall own (i) all Centocor Program Technology (whether or not
patentable) and (ii) all Improvements made during the course of and pursuant to
activities carried out under this Agreement solely by employees of or agents to
or others obligated to assign inventions to Centocor.  The Party solely owning any Technology
hereunder shall be the sole owner of all Patent Rights with respect thereto.
All determinations of inventive contribution shall be as determined by United
States laws of inventorship.  Subject to
the terms of Section 7.2 below relating to Improvements, the Party solely
owning an invention hereunder will be solely responsible, at its own cost and
expense and in its sole discretion, for the filing, prosecution and maintenance
of any inventorship

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

39

 

certificate(s),
patent application(s) and patent(s) thereon.

 

(b)                                  Joint
Technology.  All Joint Program
Technology and all Improvements made during the course of and pursuant to
activities carried out under this Agreement jointly by employees of or agents
of or others obligated to assign inventions to ImmunoGen and Centocor shall be
jointly owned by ImmunoGen and Centocor. 
All determinations of inventive contribution shall be as determined by
United States laws of inventorship.  The
Parties shall also jointly own any Patent Rights covering any such Joint
Program Technology and/or jointly-owned Improvements.  The terms of Section 7.2 below relating
to Joint Program Technology shall apply to any such Patent Rights.

 

(c)                                   Disclosure.  As regards any ImmunoGen Program Technology
or Improvement hereunder or any Centocor Program Technology or Improvement
hereunder, each Party shall provide to the other Party any invention disclosure
made during the course of performance of this Agreement and relating to
activities carried out hereunder within [********] days after such Party
receives such disclosure from its employees, agents or others obligated to
assign inventions to such Party.

 

7.2                               Patent Filing, Prosecution and Maintenance.

 

(a)                                   ImmunoGen
Rights.  Subject
to the other terms of this Section 7.2, ImmunoGen shall have the right to
prepare, file, prosecute, obtain and maintain, at its sole cost and expense,
all Licensed Patent Rights and all Patent Rights covering Improvements made
during the course of and pursuant to activities carried out under this
Agreement solely by employees of or agents to or others obligated to assign
inventions to ImmunoGen.  ImmunoGen will
keep Centocor reasonably informed of the status of each such filing,
prosecution and maintenance, including, without limitation, by using reasonable
commercial efforts to provide Centocor a reasonable time prior to taking or
failing to take any action that would affect the scope or validity of any such
filing (including the substantially narrowing, cancellation or abandonment of
any claim(s) without retaining the right to pursue such subject matter in a
separate application, or the failure to file or perfect the filing of any
claim(s) in any country), with prior written notice of such proposed action or
inaction so that Centocor has a reasonable

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

40

 

opportunity to
review and comment.  If ImmunoGen fails
to undertake the filing(s) of any patent application with respect to any
invention under such Licensed Patent Rights or such Patent Rights covering
Improvements within [********] days after receipt of written notice from
Centocor that Centocor believes filing of such an application by ImmunoGen is
appropriate, Centocor may undertake such filing(s) at its own expense.

 

(b)                                  Centocor
Rights.  Subject to the other terms
of this Section 7.2, Centocor shall have the right to prepare, file,
prosecute, obtain and maintain, at its sole cost and expense, all Licensed
Patent Rights and all Patent Rights covering Improvements made during the
course of and pursuant to activities carried out under this Agreement solely by
employees of or agents to or others obligated to assign inventions to
Centocor.  Centocor will keep ImmunoGen
reasonably informed of the status of each such filing, prosecution and
maintenance, including, without limitation, by using reasonable commercial
efforts to provide ImmunoGen a reasonable time prior to taking or failing to
take any action that would affect the scope or validity of any such filing
(including the substantially narrowing, cancellation or abandonment of any
claim(s) without retaining the right to pursue such subject matter in a
separate application, or the failure to file or perfect the filing of any
claim(s) in any country), with prior written notice of such proposed action or
inaction so that ImmunoGen has a reasonable opportunity to review and
comment.  If Centocor fails to undertake
the filing(s) of any patent application with respect to any invention under
such Patent Rights covering Improvements within [********] days after receipt
of written notice from ImmunoGen that ImmunoGen believes filing of such an
application by Centocor is appropriate, ImmunoGen may undertake such filing(s)
at its own expense.

 

(c)                                   Joint
Program Technology.  As regards any
Joint Program Technology, the Party from whom the majority of the data
underlying any such Joint Program Technology arose (the “controlling Party”)
will have the first right, but not the obligation, to undertake filing(s),
prosecution and maintenance of inventorship certificate(s), patent application(s)
and patent(s) thereon.  In connection
with any such filing(s), the filing Party will use patent counsel mutually
acceptable to each Party (in its reasonable determination) and the Parties
will, prior to

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

41

 

filing of the
patent application, agree on mutually acceptable sharing of the costs and
expenses of such filing(s), prosecution and maintenance.  In any case the filing Party (i) will provide
the non-controlling Party with a copy of any such proposed patent application
for review and comment reasonably in advance of filing, and (ii) will keep the
non-controlling Party reasonably informed of the status of such filing,
prosecution and maintenance, including, without limitation, (A) by providing
the non-controlling Party with copies of all communications received from or
filed in patent office(s) with respect to such filing, and (B) by providing the
non-controlling Party, a reasonable time prior to taking or failing to take any
action that would affect the scope or validity of any such filing (including
the substantially narrowing, cancellation or abandonment of any claim(s)
without retaining the right to pursue such subject matter in a separate
application, or the failure to file or perfect the filing of any claim(s) in
any country), with prior written notice of such proposed action or inaction so
that the non-controlling Party has a reasonable opportunity to review and
comment. If the Party from whom the majority of the data underlying any such
Joint Program Technology fails to undertake the filing(s) of any such patent
application with respect to any such Joint Program Technology within [********]
days after receipt of written notice from the other Party that the other Party
believes filing(s) of such an application by such Party is appropriate, such
other Party may undertake such filing(s) at its own expense, in which case the
non-filing Party will assign all of its rights to such Joint Program Technology
to the filing Party and any subsequently issued patent thereon will be owned
solely by the filing Party.  Either Party
may assign its rights hereunder to any Joint Program Technology, inventorship
certificate, patent application or patent to the other Party, who will then have
the right, in its discretion, to assume the filing, prosecution and/or
maintenance thereof as the sole owner thereof and at its sole cost and expense.

 

7.3                               Notice
of Infringement.  If, during the
Term of this Agreement, either Party learns of any actual, alleged or
threatened infringement by a Third Party of any Licensed Patent Rights under
this Agreement, such Party shall promptly notify the other Party and shall
provide such other Party with available evidence of such infringement.

 

 

Portions
of this Exhibit were omitted and have been filed separately with the Secretary
of the Commission Pursuant to the Company’s application requesting confidential
investment under Rule 24b-2 under the Securities Exchange Ace of 1934.

 

42

 

7.4                               Infringement of Patent Rights.

 

(a)                                   ImmunoGen
Rights to Control.  ImmunoGen shall
have the first right (but not the obligation), at its own expense, to bring and
control a suit (or take other appropriate legal action) against any actual,
alleged or threatened infringement of the Licensed Patent Rights, and Patent
Rights with respect to Improvements made by ImmunoGen, with legal counsel of
its own choice.  Centocor shall have the
right, at its own expense, to be joined as a party plaintiff and to be represented
in any such action by ImmunoGen by counsel of Centocor’s own choice; provided,
however, that under no circumstances shall the foregoing affect the
right of ImmunoGen to bring and control the suit as described in the first
sentence of this Section 7.4(a).  No
settlement may be entered into by ImmunoGen however, without the written
consent of Centocor, which consent shall not be unreasonably withheld or
delayed, if such settlement would have a material adverse effect on Centocor’s
interests.  If ImmunoGen does not file
any action or proceeding against such infringement within [****************]
days after the later of (i) ImmunoGen’s notice to Centocor under
Section 7.3 above, (ii) Centocor’s notice to ImmunoGen under
Section 7.3 above, or (iii) a written request from Centocor to take action
with respect to such infringement, then Centocor shall have the right (but not
the obligation), at its own expense, to bring suit (or take other appropriate
legal action) against such actual, alleged or threatened infringement, with
legal counsel of its own choice. ImmunoGen shall have the right, at its own
expense, to be represented in any such action by Centocor by counsel of
ImmunoGen’s own choice.  Any damages,
monetary awards or other amounts recovered, whether by judgment or settlement,
pursuant to any suit, proceeding or other legal action taken under this
Section 7.4(a), shall first be applied to reimburse the costs and expenses
(including attorneys’ fees) of the Party bringing such suit or proceeding or
taking such other legal action, then to the costs and expenses (including
attorneys’ fees), if any, of the other Party and second, to Centocor in
reimbursement for lost sales associated with Licensed Products and to ImmunoGen
in reimbursement for lost royalties owing hereunder based on such lost
sales.  Any other damages, awards or
amounts recovered (including for punitive damages) shall be allocated as
follows:  (A) if Centocor is the Party
bringing such suit or proceeding or taking such other legal action, [********]
percent (**%) to Centocor and [********] percent (**%) to ImmunoGen, (B) if
ImmunoGen is the

 

 

Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission Pursuant to the
Company’s application requesting confidential investment under Rule 24b-2 under
the Securities Exchange Ace of 1934.

 

43

 

Party bringing such suit or proceeding or taking such
other legal action, [*************] (***%) to ImmunoGen and (C) if the suit is
brought jointly, [********] percent (**%) to each Party.  If a Party brings any such action or
proceeding hereunder, the other Party agrees to be joined as party plaintiff if
necessary to prosecute such action or proceeding, and to give the Party
bringing such action or proceeding reasonable assistance and authority to file
and prosecute the suit; provided, however, that neither Party
shall be required to transfer any right, title or interest in or to any
property to the other Party or any Third Party to confer standing on a Party
hereunder.

 

(b)                                  Infringement
of Joint Program Technology.  With
respect to Joint Program Technology, the controlling Party (as defined in
Section 7.2(b)) shall have the primary right, but not the obligation, to
institute, prosecute and control any action or proceeding with respect to
infringement of such Patents, by counsel of its own choice and at its own
expense; provided, however, no settlement may be entered into by
the controlling Party without the written consent of the other Party, which
consent shall not be unreasonably withheld or delayed, if such settlement would
have a material adverse effect on such other Party’s interest.  In any event, the Parties will consult with
each other in good faith regarding the best manner in which to proceed in
connection with any actual, alleged or threatened infringement of any Patent
Rights jointly owned by ImmunoGen and Centocor under this Agreement, including
actions against any alleged infringer.

 

7.5                               Third
Party Patents.  If any Third
Party claims that a patent it owns or controls claims any aspect of a Licensed
Product or its manufacture, use or sale, the Party with notice of such claim
shall notify the other Party promptly, and the Parties shall as soon as
practicable thereafter discuss in good faith regarding the best response.

 

7.6                               Patent Assignment.  Neither Party may assign its interest in
rights under Joint Program Technology or any Patent Rights claiming a Licensed
Product, except with the prior written consent of the other Party, such consent
not to be unreasonably withheld or delayed; provided, however, that either
Party may assign such rights without consent of the other Party to a permitted
assignee under this Agreement.

 

 

Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission Pursuant to the
Company’s application requesting confidential investment under Rule 24b-2 under
the Securities Exchange Ace of 1934.

 

44

 

7.7                               Notices Relating to the Act.  ImmunoGen shall notify Centocor of the
issuance of each U.S. patent included in the Licensed Patent Rights, giving the
date of issue and patent number for each such patent.  ImmunoGen and Centocor each shall immediately
give notice to the other of any certification filed under the “U.S. Drug Price
Competition and Patent Term Restoration Act of 1984” (hereinafter the “Act”),
including, but not necessarily limited to, notices pursuant to §§101 and 103 of
the Act from persons who have filed an abbreviated NDA (“ANDA”) or a “paper”
NDA claiming that Patent Rights covering ImmunoGen Program Technology, Centocor
Program Technology, or Joint Program Technology is invalid or that infringement
will not arise from the manufacture, use or sale of any Licensed Product by a
Third Party.  The following provisions
shall apply to any such certification:

 

(a)                                  If
Centocor decides not to bring infringement proceedings against the entity
making such a certification or otherwise fails to give notice to ImmunoGen of
its decision within [********] days
after receipt of notice of such certification, ImmunoGen shall have the right,
but shall not be required, to bring suit against the Third Party.

 

(b)                                 Any
suit by Centocor or ImmunoGen under this Section 7.7 shall either be in the
name of Centocor or in the name
of ImmunoGen, or jointly in the name of Centocor and ImmunoGen, as may be
required by law.

 

(c)                                  For
purposes of this Section 7.7, the Party not bringing suit shall execute such
legal papers reasonably
necessary for the prosecution of such suit as may be reasonably requested by
the Party bringing suit.

 

7.8                               Patent
Term Extensions.  In connection
with the Development and Commercialization of any Licensed Product, ImmunoGen
hereby authorizes Centocor (a) to provide in any NDA filed with respect to any
such Licensed Product a list of patents which includes the Licensed Patent
Rights that relate to such Licensed Product; (b) subject to Section 7.4 of this
Agreement, to commence suit for infringement of the Licensed Patent Rights that
relate to such Licensed Product under §271(e) (2) of Title 35 of the United
States Code; and (c) subject to Section 7.4 of this Agreement, to apply for an
extension of the term of any patent included in the Licensed Patent Rights that
relate to such Licensed Product.  In the
event that

 

 

Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission Pursuant to the
Company’s application requesting confidential investment under Rule 24b-2 under
the Securities Exchange Ace of 1934.

 

45

 

applicable law in any country provides for the
extension of the term of any patent included in the Licensed Patent Rights that
relate to such Licensed Product, such as under the Act, the Supplementary
Certificate of Protection of the Member States of the European Union and other
similar measures in any other country, ImmunoGen shall apply for and use
commercially reasonable efforts to obtain such an extension or, should the law
require Centocor to so apply, ImmunoGen shall grant permission to Centocor to
do so.  Centocor and ImmunoGen agree to
cooperate with one another in obtaining such extension.  ImmunoGen agrees to cooperate with Centocor
or its Sublicensee, as applicable, in the exercise of the authorization granted
herein and shall execute such documents and take such additional action as
Centocor may reasonably request in connection therewith, including, if
necessary, permitting itself to be joined as a Party in any suit for
infringement brought by Centocor hereunder.

 

7.9                               Trademarks.  All Licensed Products shall be sold under one
or more trademarks and trade names selected and owned by Centocor in the
Territory.  Centocor shall control the
preparation, prosecution and maintenance of applications related to all such
trademarks and trade names in the Territory, at its sole cost and expense and
at its sole discretion.  ImmunoGen shall
notify Centocor promptly upon learning of any actual, alleged or threatened
infringement of a trademark or trade name applicable to a Licensed Product in
the Territory, or of any unfair trade practices, trade dress imitation, passing
off of counterfeit goods, or like offenses in the Territory.  All of the costs, expenses and legal fees in
bringing, maintaining and prosecuting any action to maintain, protect or defend
any owned by Centocor hereunder, and any damages or other recovery, shall be
Centocor’s sole responsibility, and taken in its sole discretion.

 

7.10                        Integration.
 This Section 7 supersedes any
agreement between the Parties as to the subject matter hereof, including,
without limitation, any provisions of the MTA relating to inventions, patent
applications and patents.

 

8.                                      TERM AND TERMINATION

 

8.1                               Term;
Expiration.  The term of this
Agreement (the “Term”) shall
expire on a country-by-country basis upon the expiration of the final royalty
payment obligation with respect

 

 

Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission Pursuant to the
Company’s application requesting confidential investment under Rule 24b-2 under
the Securities Exchange Ace of 1934.

 

46

 

to the final Licensed Product under Section 5.3.1
above.  Upon the expiration of the Term
of this Agreement, Centocor shall have a fully paid-up, irrevocable, freely
transferable and sublicensable license in the Territory under the Licensed
Patent Rights and Licensed Technology, to Develop, have Developed, Commercialized,
have Commercialized, make, have made, use, have used, sell, have sold, offer
for sale, import and have imported any and all Licensed Products in the
Territory.

 

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

 

(a)                                   Voluntary
Termination by Centocor.  Centocor
shall have the right to terminate this Agreement at any time upon not less than
[********] days’ prior written notice to ImmunoGen.

 

(b)                                  Breach.  A Party may terminate this Agreement and the
licenses granted herein, effective upon written notice to the other Party, upon
any breach by the other Party of any material obligation or condition of this
Agreement, which material breach remains uncured [********] days after the
non-breaching Party gives a first written notice to the other Party describing
such breach in reasonable detail; provided, however, that in the
event of a payment breach by Centocor under this Agreement, the applicable cure
period shall be [********] days (in lieu of [********] days) but the other
terms of this Section 8.2(b) shall apply to termination in connection with
any such payment breach.  Notwithstanding
anything set forth herein, if the asserted material breach is cured or shown to
be non-existent within the applicable cure period, the first notice of breach hereunder
shall be deemed automatically withdrawn and of no effect.

 

(c)                                   Bankruptcy.  A Party may terminate this Agreement,
effective on written notice to the other Party, in the event the other Party
shall have become insolvent or bankrupt, or shall have made an assignment for
the benefit of its creditors, or there shall have been appointed a trustee or
receiver of the other Party or for all or a substantial part of its property,
or any case or proceeding shall have been commenced or other action taken by or
against the other Party in bankruptcy or seeking reorganization, liquidation,
dissolution, winding-up, arrangement, composition or readjustment of its debts
or any other relief under any bankruptcy, insolvency, reorganization or other
similar act or law of any jurisdiction now or hereafter in effect, or there

 

 

Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission Pursuant to the
Company’s application requesting confidential investment under Rule 24b-2 under
the Securities Exchange Ace of 1934.

 

47

 

shall have been issued a warrant of attachment,
execution, distraint or similar process against any substantial part of the
property of the other Party, and any such foregoing events shall have continued
for [********] days undismissed, unbonded and undischarged.  All rights and licenses granted under this
Agreement are, and shall be deemed to be, for purposes of Section 365(n)
of the United States Bankruptcy Code, licenses of rights to “intellectual
property” as defined under Section 101(56) of the United States Bankruptcy
Code.  The Parties agree that in the
event of the commencement of a bankruptcy proceeding by or against one Party
hereunder under the United States Bankruptcy Code, the other Party shall be
entitled to complete access to any such intellectual property, and all
embodiments of such intellectual property, pertaining to the rights granted in
the licenses hereunder of the Party by or against whom a bankruptcy proceeding
has been commenced, subject, however, to payment of the milestone amounts and
royalties set forth in this Agreement through the effective date of any
termination hereunder.

 

8.3                               Effects
of Termination.  Upon any
termination of this Agreement by either Party under Section 8.2, as of the
effective date of such termination, all relevant licenses and sublicenses
granted by ImmunoGen to Centocor hereunder shall terminate automatically.  Notwithstanding the foregoing, and unless
ImmunoGen specifies otherwise in writing, (a) no such termination of this
Agreement shall be construed as a termination of any valid sublicense of any
Sublicensee hereunder, and thereafter each such Sublicensee shall be considered
a direct licensee of ImmunoGen, provided, that, (i) such
Sublicensee is then in full compliance with all terms and conditions of its
sublicense, (ii) all accrued payments obligations to ImmunoGen have been paid,
and (iii) such Sublicensee agrees at least [**************] prior to the
effective date of such termination to assume all obligations of Centocor under
this Agreement, and (b) Centocor and its Sublicensees shall have the right, for
[********] months or such longer time period (if any) on which the Parties
mutually agree in writing, to sell or otherwise dispose of all Licensed
Products then on hand, with royalties to be paid to ImmunoGen on all Net Sales
of such Licensed Products as provided for in this Agreement.

 

8.4                               Remedies. 
Except as otherwise expressly set forth in this Agreement, the
termination provisions of this Section 8 are in addition to any other
relief and remedies available

 

 

Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission Pursuant to the
Company’s application requesting confidential investment under Rule 24b-2 under
the Securities Exchange Ace of 1934.

 

48

 

to either Party at law.

 

8.5                               Surviving
Provisions.  Notwithstanding any provision herein to the
contrary, the rights and obligations of the Parties set forth in Sections
5.8(b), 6, 7.2, 7.4, 8.3, 8.4, 8.5, 9.3, 10 and 11 as well as any rights or
obligations otherwise accrued hereunder (including any accrued payment
obligations), shall survive the expiration or termination of the Term of this
Agreement. Without limiting the generality of the foregoing, Centocor shall
have no obligation to make any milestone or royalty payment to ImmunoGen that
has not accrued prior to the effective date of any termination of this Agreement,
but shall remain liable for all such payment obligations accruing prior to the
effective date of such termination.

 

9.                                      REPRESENTATIONS AND WARRANTIES

 

9.1                               ImmunoGen
Representations.  ImmunoGen
represents and warrants to Centocor that: 
(a) the execution and delivery of this Agreement and the performance of
the transactions contemplated hereby have been duly authorized by all
appropriate ImmunoGen corporate action; (b) this Agreement is a legal and valid
obligation binding upon ImmunoGen and enforceable in accordance with its terms,
and the execution, delivery and performance of this Agreement by the Parties
does not conflict with any agreement, instrument or understanding to which
ImmunoGen is a party or by which it is bound; (c) ImmunoGen has the full right
and legal capacity to grant the licenses and rights to Centocor pursuant to
Section 2 above without violating the rights of any Third Party; (d) to
ImmunoGen’s knowledge, no Patent Rights within the Licensed Patent Rights are
invalid or unenforceable and as of the Effective Date no patents within the
Licensed Patent Rights have expired; (e) as of the Effective Date, ImmunoGen
has received no notice from a Third Party claiming that the exercise of the
license granted hereunder to Centocor will infringe the issued patents of any
such Third Party; (f) to the extent it undertakes to manufacture Preclinical
Materials under this Agreement, it shall comply with all statutes and laws
relating to the manufacture and supply of such Preclinical Materials being supplied
hereunder, including, without limitation, those enforced by the FDA; and (g)
ImmunoGen has read the [**************] on the [********] of [********] (the “Policy”)

 

 

Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission Pursuant to the
Company’s application requesting confidential investment under Rule 24b-2 under
the Securities Exchange Ace of 1934.

 

49

 

attached hereto as Schedule F and agrees, in relation
to Preclinical Materials manufactured and supplied by ImmunoGen hereunder, to
[***************] only as permitted by the Policy.

 

9.2                               Centocor
Representations.  Centocor
represents and warrants to ImmunoGen that: 
(a) the execution and delivery of this Agreement and the performance of
the transactions contemplated hereby have been duly authorized by all
appropriate Centocor corporate action; and (b) this Agreement is a legal and
valid obligation binding upon Centocor and enforceable in accordance with its
terms, and the execution, delivery and performance of this Agreement by the
Parties does not conflict with any agreement, instrument or understanding to
which Centocor is a party or by which it is bound.

 

9.3                               No Warranties.

 

(a)                                   Nothing
in this Agreement is or shall be construed as:

 

(i)                                     a
warranty or representation by ImmunoGen as to the validity or scope of any
patent application or patent within the Licensed Patent Rights;

 

(ii)                                  a
warranty or representation that anything made, used, sold or otherwise disposed
of under any license granted in this Agreement is or will be free from
infringement of patents, copyrights, and other rights of Third Parties.

 

(b)                                  Except
as expressly set forth in this Agreement, NEITHER PARTY MAKES ANY
REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED.  WITHOUT LIMITING THE FOREGOING,
THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE, THAT ANY LICENSED PRODUCT WILL BE SUCCESSFULLY DEVELOPED OR
MARKETED, OR THAT THE DEVELOPMENT, MANUFACTURE, SALE, IMPORTATION OR USE OF THE
LICENSED PRODUCT(S) WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR
OTHER RIGHTS, OR ANY OTHER EXPRESS OR IMPLIED WARRANTIES.

 

 

Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission Pursuant to the
Company’s application requesting confidential investment under Rule 24b-2 under
the Securities Exchange Ace of 1934.

 

50

 

10.                               INDEMNIFICATION; LIABILITY

 

10.1                        Indemnification.

 

(a)                                   Centocor
Indemnity.  Subject to
Section 10.1(b) below and the remainder of this Section 10, Centocor
shall indemnify, defend and hold harmless ImmunoGen, its Affiliates and their
respective directors, officers, employees, and agents and their respective
successors, heirs and assigns (the “ImmunoGen Indemnitees”), from and against any liability, damage, loss or
expense (including reasonable attorneys’ fees and expenses of litigation)
incurred by or imposed upon such ImmunoGen Indemnitees, or any of them, in
connection with any Third Party claims, suits, actions, demands or judgments,
including, without limitation, personal injury and product liability matters,
that arise out of or relate to (i) any actions or omissions of Centocor or any
Affiliate or Sublicensee of Centocor in the development, testing, production,
manufacture, supply, promotion, import, sale or use by any person of any
Licensed Product (or any component thereof) manufactured or sold by Centocor or
any Affiliate or Sublicensee of Centocor under this Agreement, (ii) any
material breach of this Agreement by Centocor or (iii) the gross negligence or
willful misconduct on the part of Centocor except to the extent of ImmunoGen’s
responsibility therefor under Section 10.1(b) below.

 

(b)                                  ImmunoGen
Indemnity.  Subject to
Section 10.1(a) above and the remainder of this Section 10, ImmunoGen
shall indemnify, defend and hold harmless Centocor its Affiliates and their
respective directors, officers, employees, and agents, and their respective
successors, heirs and assigns (the “Centocor Indemnitees”), from and against any liability, damage, loss or
expense (including reasonable attorneys’ fees and expenses of litigation)
incurred by or imposed upon such Centocor Indemnitees, or any of them, in
connection with any Third Party claims, suits, actions, demands or judgments,
including, without limitation, personal injury and product liability matters,
that arise out of or relate to (i) any material breach of this Agreement by
ImmunoGen, or (ii) the gross negligence or willful misconduct on the part of
ImmunoGen, except to the extent of Centocor’s responsibility therefor under
Section 10.1(a) above.

 

10.2                        Indemnification
Procedures.  In the event that
any Indemnitee is seeking

 

 

Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission Pursuant to the
Company’s application requesting confidential investment under Rule 24b-2 under
the Securities Exchange Ace of 1934.

 

51

 

indemnification under Section 10.1 above from a
Party (the “Indemnifying Party”),
the other Party shall notify the Indemnifying Party of such claim with respect
to such Indemnitee as soon as reasonably practicable after the Indemnitee
receives notice of the claim, and the Party (on behalf of itself and such
Indemnitee) shall permit the Indemnifying Party to assume direction and control
of the defense of the claim (including the right to settle the claim solely for
monetary consideration) and shall cooperate as requested (at the expense of the
Indemnifying Party) in the defense of the claim.

 

10.3                        Liability.  NOTWITHSTANDING ANYTHING ELSE IN THIS
AGREEMENT OR OTHERWISE, NEITHER PARTY WILL BE LIABLE WITH RESPECT TO ANY
SUBJECT MATTER OF THIS AGREEMENT UNDER ANY CONTRACT, NEGLIGENCE, STRICT
LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR ANY INDIRECT, INCIDENTAL,
CONSEQUENTIAL OR PUNITIVE DAMAGES OR LOST PROFITS OR COST OF PROCUREMENT OF
SUBSTITUTE GOODS, TECHNOLOGY OR SERVICES.

 

10.4                        Insurance Proceeds. Any
indemnification hereunder shall be made net of any insurance proceeds recovered
by the Indemnified Party; provided, however, that if, following the payment to
the Indemnified Party of any amount under this Article 10, such Indemnified
Party recovers any insurance proceeds in respect of the claim for which such
indemnification payment was made, the Indemnified Party shall promptly pay an
amount equal to the amount of such proceeds (but not exceeding the amount of such
indemnification payment) to the Indemnifying Party.

 

10.5                        Insurance. Centocor and
ImmunoGen shall use all commercially reasonable efforts to maintain insurance,
including product liability insurance, with respect to its activities
hereunder.  Such insurance shall be in
such amounts and subject to such deductibles as the Parties may agree, based
upon standards prevailing in the industry at the time.  Centocor may satisfy its obligations under
this Section through self-insurance to the same extent.

 

 

Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission Pursuant to the
Company’s application requesting confidential investment under Rule 24b-2 under
the Securities Exchange Ace of 1934.

 

52

 

11.                               MISCELLANEOUS

 

11.1                        Entire
Agreement; Amendments.  This is
the entire Agreement between the Parties with respect to the subject matter
herein, and supersedes any prior agreements, understandings, negotiations or
correspondence between the Parties respecting the subject matter hereof,
whether written or verbal (including, without limitation, the MTA, and that
certain Confidentiality Agreement effective [***************].  No modification or other amendment of this
Agreement shall be effective unless in writing and signed by a fully authorized
representative of each Party.

 

11.2                        Waiver.  The terms or conditions of this Agreement may
be waived only by a written instrument executed by a duly authorized
representative of the Party waiving compliance. 
The failure of either Party at any time or times to require performance
of any provision hereof shall in no manner affect its rights at a later time to
enforce the same.  No waiver by either
Party of any condition or term shall be deemed as a continuing waiver of such
condition or term or of another condition or term.

 

11.3                        Governing
Law.  This Agreement will be
construed, interpreted and applied in accordance with the laws of the
Commonwealth of Massachusetts applicable to contracts entered into and to be
performed entirely within the Commonwealth of Massachusetts without giving
effect to any choice of law principles that would require the application of
the laws of a different state.  Notwithstanding
the foregoing, any dispute, controversy or claim relating to the scope,
validity, enforceability or infringement of any Patent Rights or other
intellectual property rights shall be governed by the law of the territory in
which such Patent Rights or other intellectual property rights were granted or
arose.

 

11.4                        Notices.  Any notices, requests, deliveries, approvals
or consents required or permitted to be given under this Agreement to Centocor
or ImmunoGen shall be in writing and shall be personally delivered or sent by
telecopy (with machine confirmation of transmission) or by overnight courier
providing evidence of receipt or certified mail, return receipt requested,
postage prepaid, in each case to the respective address specified below (or to
such address as may be specified in writing to the other Party hereto):

 

 

Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission Pursuant to the
Company’s application requesting confidential investment under Rule 24b-2 under
the Securities Exchange Ace of 1934.

 

53

 

	
  If to ImmunoGen:

  	
   

  	
  ImmunoGen, Inc.

  
	
   

  	
   

  	
  128 Sidney Street

  
	
   

  	
   

  	
  Cambridge, MA 02139

  
	
   

  	
   

  	
  Attn: Chief Executive
  Officer

  
	
   

  	
   

  	
  [*****************]

  
	
   

  	
   

  	
   

  
	
  with a copy to

  	
   

  	
  Mintz, Levin, Cohn,
  Ferris, Glovsky and Popeo, P.C.

  
	
   

  	
   

  	
  One Financial Center

  
	
   

  	
   

  	
  Boston, MA 02111

  
	
   

  	
   

  	
  Attn:
  [****************], Esq.

  
	
   

  	
   

  	
  [*****************]

  
	
   

  	
   

  	
   

  
	
  If to Centocor:

  	
   

  	
  Centocor, Inc.

  
	
   

  	
   

  	
  200 Great Valley
  Parkway

  
	
   

  	
   

  	
  Malvern, Pennsylvania
  19355

  
	
   

  	
   

  	
  Attn: President

  
	
   

  	
   

  	
  [*****************]

  
	
   

  	
   

  	
   

  
	
  With copy to:

  	
   

  	
  Office of General
  Counsel

  
	
   

  	
   

  	
  Johnson & Johnson

  
	
   

  	
   

  	
  One Johnson &
  Johnson Plaza

  
	
   

  	
   

  	
  New Brunswick, New
  Jersey 08933

  
	
   

  	
   

  	
  [*****************]

  

 

Such notices shall be
deemed to have been sufficiently given on: 
(a) the date sent if delivered in person or transmitted by facsimile, or
(b) the next business day after dispatch in the case of overnight courier.

 

11.5                        No
Implied Licenses.  Except as
expressly set forth elsewhere in this Agreement, neither Party grants to the
other Party any right or license to any of its intellectual property.

 

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

 

11.7                        Assignment.  This Agreement may not be assigned by either
Party without the consent of the other, except that each Party may, without
such consent, assign this Agreement and the rights, obligations and interests
of such Party, in whole or in part, to any of its Affiliates, to any purchaser
of all or substantially all of its assets in the line of business to which this
Agreement pertains or to any successor corporation resulting from any merger or
consolidation

 

 

Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission Pursuant to the
Company’s application requesting confidential investment under Rule 24b-2 under
the Securities Exchange Ace of 1934.

 

54

 

of such Party with or into such corporations.

 

11.8                        Force
Majeure.  Neither Party shall be
liable for failure of or delay in performing obligations set forth in this
Agreement, and neither shall be deemed in breach of its obligations, if such
failure or delay is due to natural disasters or any causes beyond the
reasonable control of such Party.  In
event of such force majeure, the Party affected thereby shall use reasonable
efforts to cure or overcome the same and resume performance of its obligations
hereunder.

 

11.9                        Construction.  The Parties hereto acknowledge and agree
that:  (a) each Party and its
counsel reviewed and negotiated the terms and provisions of this Agreement and
have contributed to its revision; (b) the rule of construction to the
effect that any ambiguities are resolved against the drafting Party shall not
be employed in the interpretation of this Agreement; and (c) the terms and
provisions of this Agreement shall be construed fairly as to each Party hereto
and not in a favor of or against any Party, regardless of which Party was
generally responsible for the preparation of this Agreement.

 

11.10                 Severability.  If any provision(s) of this Agreement are or
become invalid, are ruled illegal by any court of competent jurisdiction or are
deemed unenforceable under then current applicable law from time to time in
effect during the term hereof, it is the intention of the Parties that the
remainder of this Agreement shall not be affected thereby provided that a Party’s
rights under this Agreement are not materially affected.  The Parties hereto covenant and agree to
renegotiate any such term, covenant or application thereof in good faith in
order to provide a reasonably acceptable alternative to the term, covenant or
condition of this Agreement or the application thereof that is invalid, illegal
or unenforceable, it being the intent of the Parties that the basic purposes of
this Agreement are to be effectuated.

 

11.11                 Status.  Nothing in this Agreement is intended or
shall be deemed to constitute a partner, agency, employer-employee, or joint
venture relationship between the Parties.

 

11.12                 Dispute
Resolution.  The Parties recognize that a bona fide
dispute as to certain matters may from time to time arise during the term of
this Agreement relating to either Party’s rights and/or obligations hereunder
or otherwise relating to the validity, enforceability or performance of this
Agreement, including disputes relating to alleged breach or termination of

 

 

Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission Pursuant to the
Company’s application requesting confidential investment under Rule 24b-2 under
the Securities Exchange Ace of 1934.

 

55

 

this Agreement but excluding any determination of the
validity of the Parties’ patents (hereinafter, a “Dispute”).  In the event of the occurrence of any such
Dispute, the Parties shall, by written notice to the other Party, have such
Dispute referred to their respective senior officers designated below (and to
any designated officer of a Centocor Sublicensee, if such Dispute involves such
Sublicensee), for attempted resolution by good faith negotiations commencing
promptly after such notice is received. 
Said designated senior officials of the Parties are as follows:

 

For Centocor:  President, Centocor Research, Development and
Supply, Inc,; and

For ImmunoGen:    Chief
Executive Officer.

 

In the event the
designated senior officials are not able to resolve such Dispute within
[********] days, the Dispute will be resolved in accordance with Schedule E
attached hereto and incorporated herein by reference.

 

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

 

11.14                 Counterparts.  This Agreement may be executed simultaneously
in one or more counterparts, each of which shall be deemed an original, but all
of which together shall constitute one and the same instrument.

 

 

Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission Pursuant to the
Company’s application requesting confidential investment under Rule 24b-2 under
the Securities Exchange Ace of 1934.

 

56

 

IN WITNESS WHEREOF, the Parties have caused this
Agreement to be executed by their duly authorized representative in two (2)
originals.

 

 

	
  CENTOCOR,
  INC.

  	
  IMMUNOGEN,
  INC.

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
  /s/
  Jay P. Siegel

  	
   

  	
  By:  

  	
  /s/ Mitchel Sayare/

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Name: 

  	
  Jay Siegel

  	
   

  	
   

  	
  Mitchel Sayare

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Title: 

  	
  President, Centocor
  Research

  	
   

  	
  Title: 

  	
  CEO

  	
   

  
	
   

  	
  Development and Supply,
  Inc.

  	
   

  	
   

  	
   

  
												

 

 

Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission Pursuant to the
Company’s application requesting confidential investment under Rule 24b-2 under
the Securities Exchange Ace of 1934.

 

57

 

APPENDIX
3.1

 

RESEARCH PLAN FOR[************]

 

YEAR 2005 (AND 2006)

 

A.                                      [***************]

B.                                      [***************]

C.                                      [********************]

 

A. 
[****************************************************

*****************************************]

 

[***********************]

 

[******]

 

[******************************************************************************************************]

 

[******]

 

[******************************************************************************************************]

 

[******]

 

[************************************************************

*********************

******************************************

******************************************

*************************************

***************************]

 

[******]

 

[************************************************************

*********************

******************************************

******************************************

*************************************

***************************]

 

[******]

 

3.1-1

 

[************************************************************

*********************

******************************************

******************************************

*************************************

***************************]

 

[******]

 

[************************************************************

******************************************

******************************************

******************************************]

 

[******]

 

[***************************************************

******************************************

******************************************

******************************************]

 

[******]

 

[****************************

***********************

***********************

*******************************]

 

[******]

 

[************************************************************

************************************************************]

 

[***************]

 

1.               [*********************************************************

*********************************************]

2.               [******************************************************************]

3.               [*****************************************************************]

4.               [********************************************************************]

[**************]

[**************]

[**************]

 

[**************]

 

3.1-2

 

12.                               B.
[**********************************************]

 

[*******************************************************]

 

[****************************************************************************************************

*********].

 

[***************************************************************************************************

****************************************************************************************************

****************************************************************************************************

****************************************************************************************************

****************************************************************************************************

************************].

 

[*****************************************************************************************************

*********************************************************************].

 

[***************************************************************************************************

****************************************************************************************************

****************************************************************************************************

************************].

 

[******************************************************************************************************

*******************************************].

 

[****************************************************************************************************

*****************************************************************************************************

*****************************************************************************************************

*********************].

 

[********************************************************************************************************

*****************************************].

 

[*****************************************************************************************************

******************************************************************************************************

******************************************************************************************************

******************].

 

3.1-3

 

[********************************************************************************************************

*****************************************].

 

[*****************************************************************************************************

******************************************************************************************************

******************************************************************************************************

******************].

 

[********************************************************************************************************

*****************************************].

 

[******************************************************************************************************

*******************************************************************************************************

*******************************************************************************************************

**************************************************************************].

 

3.1-4

 

C.             [************************]

 

[********************************************************************************************************

***************************************************************]:

 

•    [**************************************************************************************************

**************************************************************************************************

**************************************************************************************************

**************************************************************************************************

**************************************************************************************************

**************************************************************************************************

**************************************************************************************************

**************************************************************************************************

**************************************************************************************************

**************************************************************************************************

**************************************************************************************************

**********************************************************************************].

 

[*********************************************************************************************************

**********************************************************************************************************

****************************************************************************************************]:

 

•    [**************************************************************************************************

**************************************************************************************************

**************************************************************************************************

**************************************************************************************************

**************************************************************************************************

**************************************************************************************************

**************************************************************************************************

**************************************************************************************************

**************************************************************************************************

********************************************].

 

3.1-5

 

SCHEDULE
A

 

LICENSED
PATENT RIGHTS

 

MAYTANSINOID CONJUGATES

(Cytotoxic agents comprising maytansinoids and their therapeutic use)

 

	
  Atty. Ref. No.

  	
   

  	
  Country

  	
   

  	
  Appl. No.

  	
   

  	
  Filing Date

  	
   

  	
  Priority Date

  	
   

  	
  Patent No.

  	
   

  	
  Issue Date

  	
   

  	
  Expiry Date

  
	
  A-5567*

  	
   

  	
  U.S.

  	
   

  	
  07/426,247

  	
   

  	
  25-Oct-89

  	
   

  	
   

  	
   

  	
  Abandoned

  	
   

  	
   

  	
   

  	
   

  
	
  A-5567-1*

  	
   

  	
  U.S.

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Rule 62 Cont.

  	
   

  	
  07/911,380

  	
   

  	
  13-Jul-92

  	
   

  	
  25-Oct-89

  	
   

  	
  5,208,020

  	
   

  	
  04-May-93

  	
   

  	
  04-May-10

  
	
  A-6190*

  	
   

  	
  U.S. Div.

  	
   

  	
  07/986,578

  	
   

  	
  07-Dec-92

  	
   

  	
  25-Oct-89

  	
   

  	
  5,416,064

  	
   

  	
  16-May-95

  	
   

  	
  16-May-12

  
	
  F89903

  	
   

  	
  Europe

  	
   

  	
  0 90 311 590.5

  	
   

  	
  23-Oct-90

  	
   

  	
  25-Oct-89

  	
   

  	
  0 425 235 B1

  	
   

  	
  25-Sep-96

  	
   

  	
  23-Oct-10

  
	
  F89903

  	
   

  	
  AT

  	
   

  	
  0 90 311 590.5

  	
   

  	
  23-Oct-90

  	
   

  	
  25-Oct-89

  	
   

  	
  0 425 235 B1

  	
   

  	
  25-Sep-96

  	
   

  	
  23-Oct-10

  
	
  F89903

  	
   

  	
  BE

  	
   

  	
  0 90 311 590.5

  	
   

  	
  23-Oct-90

  	
   

  	
  25-Oct-89

  	
   

  	
  0 425 235 B1

  	
   

  	
  25-Sep-96

  	
   

  	
  23-Oct-10

  
	
  F89903

  	
   

  	
  CH

  	
   

  	
  0 90 311 590.5

  	
   

  	
  23-Oct-90

  	
   

  	
  25-Oct-89

  	
   

  	
  0 425 235 B1

  	
   

  	
  25-Sep-96

  	
   

  	
  23-Oct-10

  
	
  F89903

  	
   

  	
  DE

  	
   

  	
  0 90 311 590.5

  	
   

  	
  23-Oct-90

  	
   

  	
  25-Oct-89

  	
   

  	
  690 28678.3-3-08

  	
   

  	
  25-Sep-96

  	
   

  	
  23-Oct-10

  
	
  F89903

  	
   

  	
  DK

  	
   

  	
  0 90 311 590.5

  	
   

  	
  23-Oct-90

  	
   

  	
  25-Oct-89

  	
   

  	
  0 425 235 B1

  	
   

  	
  25-Sep-96

  	
   

  	
  23-Oct-10

  
	
  F89903

  	
   

  	
  ES

  	
   

  	
  0 90 311 590.5

  	
   

  	
  23-Oct-90

  	
   

  	
  25-Oct-89

  	
   

  	
  0 425 235 B1

  	
   

  	
  25-Sep-96

  	
   

  	
  23-Oct-10

  
	
  F89903

  	
   

  	
  FR

  	
   

  	
  0 90 311 590.5

  	
   

  	
  23-Oct-90

  	
   

  	
  25-Oct-89

  	
   

  	
  0 425 235 B1

  	
   

  	
  25-Sep-96

  	
   

  	
  23-Oct-10

  
	
  F89903

  	
   

  	
  GB

  	
   

  	
  0 90 311 590.5

  	
   

  	
  23-Oct-90

  	
   

  	
  25-Oct-89

  	
   

  	
  0 425 235 B1

  	
   

  	
  25-Sep-96

  	
   

  	
  23-Oct-10

  
	
  F89903

  	
   

  	
  IT

  	
   

  	
  0 90 311 590.5

  	
   

  	
  23-Oct-90

  	
   

  	
  25-Oct-89

  	
   

  	
  0 425 235 B1

  	
   

  	
  25-Sep-96

  	
   

  	
  23-Oct-10

  
	
  F89903

  	
   

  	
  LI

  	
   

  	
  0 90 311 590.5

  	
   

  	
  23-Oct-90

  	
   

  	
  25-Oct-89

  	
   

  	
  0 425 235 B1

  	
   

  	
  25-Sep-96

  	
   

  	
  23-Oct-10

  
	
  F89903

  	
   

  	
  LU

  	
   

  	
  0 90 311 590.5

  	
   

  	
  23-Oct-90

  	
   

  	
  25-Oct-89

  	
   

  	
  0 425 235 B1

  	
   

  	
  25-Sep-96

  	
   

  	
  23-Oct-10

  
	
  F89903

  	
   

  	
  NL

  	
   

  	
  0 90 311 590.5

  	
   

  	
  23-Oct-90

  	
   

  	
  25-Oct-89

  	
   

  	
  0 425 235 B1

  	
   

  	
  25-Sep-96

  	
   

  	
  23-Oct-10

  
	
  F89903

  	
   

  	
  SE

  	
   

  	
  0 90 311 590.5

  	
   

  	
  23-Oct-90

  	
   

  	
  25-Oct-89

  	
   

  	
  0 425 235 B1

  	
   

  	
  25-Sep-96

  	
   

  	
  23-Oct-10

  
	
  F89902

  	
   

  	
  Canada

  	
   

  	
  2,026,147-1

  	
   

  	
  25-Sep-90

  	
   

  	
  25-Oct-89

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F89904

  	
   

  	
  Japan

  	
   

  	
  2-290,625

  	
   

  	
  25-Oct-90

  	
   

  	
  25-Oct-89

  	
   

  	
  3155998

  	
   

  	
  09-Feb-01

  	
   

  	
  25-Oct-10

  

 

MAYTANSINOID PROCESS

(Process for the preparation and purification of thiol-containing
maytansinoids)

 

	
  Atty. Ref. No.

  	
   

  	
  Country

  	
   

  	
  Appl. No.

  	
   

  	
  Filing Date

  	
   

  	
  Priority Date

  	
   

  	
  Patent No.

  	
   

  	
  Issue Date

  	
   

  	
  Expiry Date

  
	
  A7752*

  	
   

  	
  U.S.

  	
   

  	
  09/641,348

  	
   

  	
  18-Aug-00

  	
   

  	
   

  	
   

  	
  6,333,410 B1

  	
   

  	
  25-Dec-01

  	
   

  	
  18-Aug-20

  
	
  A8451

  	
   

  	
  U.S.

  	
   

  	
  10/410,143

  	
   

  	
  10-Apr-03

  	
   

  	
  18-Aug-00

  	
   

  	
  Re-Issue

  	
   

  	
   

  	
   

  	
   

  
	
  A8707

  	
   

  	
  U.S. (Div)

  	
   

  	
  10/758,264

  	
   

  	
  16-Jan-04

  	
   

  	
  19-Aug-00

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F145222

  	
   

  	
  PCT

  	
   

  	
  PCT/US01/10816

  	
   

  	
  26-Apr-01

  	
   

  	
  18-Aug-00

  	
   

  	
  Pub. No. WO 02/16368 A1 02/28/02)

  	
   

  	
   

  	
   

  	
   

  
	
  F145201

  	
   

  	
  Australia

  	
   

  	
  53118/01

  	
   

  	
  26-Apr-01

  	
   

  	
  18-Aug-00

  	
   

  	
  763107

  	
   

  	
  30-Oct-03

  	
   

  	
  26-Apr-21

  
	
  F145202

  	
   

  	
  Canada

  	
   

  	
  2373554

  	
   

  	
  26-Apr-01

  	
   

  	
  18-Aug-00

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F145203

  	
   

  	
  Europe

  	
   

  	
  01926594-1

  	
   

  	
  26-Apr-01

  	
   

  	
  18-Aug-00

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F145204

  	
   

  	
  Japan

  	
   

  	
  2002-521468

  	
   

  	
  26-Apr-01

  	
   

  	
  18-Aug-00

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F145239

  	
   

  	
  Hong Kong

  	
   

  	
  03108241.7

  	
   

  	
  13-Nov-03

  	
   

  	
  18-Aug-00

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  

 

A-1

 

MAYTANSINOID CONJUGATE PROCESS

(Methods for the preparation of cytotoxic conjugates of maytansinoids
and cell binding agents)

 

	
  Atty. Ref. No.

  	
   

  	
  Country

  	
   

  	
  Appl. No.

  	
   

  	
  Filing Date

  	
   

  	
  Priority Date

  	
   

  	
  Patent No.

  	
   

  	
  Issue Date

  	
   

  	
  Expiry Date

  
	
  A7970*

  	
   

  	
  U.S.

  	
   

  	
  09/867,598

  	
   

  	
  31-May-01

  	
   

  	
   

  	
   

  	
  6,441,163 B1

  	
   

  	
  27-Aug-02

  	
   

  	
  31-May-21

  
	
  A8369

  	
   

  	
  U.S.

  	
   

  	
  10/161,651

  	
   

  	
  05-Jun-02

  	
   

  	
  31-May-01

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F154222

  	
   

  	
  PCT

  	
   

  	
  PCT/US02/03378

  	
   

  	
  14-Feb-02

  	
   

  	
  31-May-01

  	
   

  	
  Pub. No. WO 02/098883 A1 (12/12/02)

  	
   

  	
   

  	
   

  	
   

  
	
  F154201

  	
   

  	
  Australia

  	
   

  	
  2002251880

  	
   

  	
  14-Feb-02

  	
   

  	
  31-May-01

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F154202

  	
   

  	
  Canada

  	
   

  	
  2,417,858

  	
   

  	
  14-Feb-02

  	
   

  	
  31-May-01

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F154203

  	
   

  	
  Europe

  	
   

  	
  02720913.9

  	
   

  	
  14-Feb-02

  	
   

  	
  31-May-01

  	
   

  	
  Pub. No. 1390370 (2/25/04)

  	
   

  	
   

  	
   

  	
   

  
	
  F154204

  	
   

  	
  Japan

  	
   

  	
  2003-502004

  	
   

  	
  14-Feb-02

  	
   

  	
  31-May-01

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F154221

  	
   

  	
  New Zealand

  	
   

  	
  523655

  	
   

  	
  14-Feb-02

  	
   

  	
  31-May-01

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F154239

  	
   

  	
  Hong Kong

  	
   

  	
  4103250.5

  	
   

  	
  14-Feb-02

  	
   

  	
  31-May-01

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  

 

ANTI-ErbB ANTIBODY-MAYTANSINOID CONJUGATES (“Genentech
Application”)

(Methods of treatment using anti-ErbB antibody-maytansinoid conjugates)

 

	
  Atty. Ref. No.

  	
   

  	
  Country

  	
   

  	
  Appl. No.

  	
   

  	
  Filing Date

  	
   

  	
  Priority Date

  	
   

  	
  Patent No.

  	
   

  	
  Issue Date

  	
   

  	
  Expiry Date

  
	
  ?

  	
   

  	
  U.S.

  	
   

  	
  60/141,316

  	
   

  	
  25-Jun-99

  	
   

  	
   

  	
   

  	
  Provisional

  	
   

  	
   

  	
   

  	
   

  
	
  PR1801R1

  	
   

  	
  U.S.

  	
   

  	
  60/189,844

  	
   

  	
  16-Mar-00

  	
   

  	
   

  	
   

  	
  Provisional

  	
   

  	
   

  	
   

  	
   

  
	
  PR1801

  	
   

  	
  U.S.

  	
   

  	
  60/329,563

  	
   

  	
  23-Jun-00

  	
   

  	
   

  	
   

  	
  Provisional

  	
   

  	
   

  	
   

  	
   

  
	
  PR1801-2

  	
   

  	
  U.S.

  	
   

  	
  60/238,327

  	
   

  	
  05-Oct-00

  	
   

  	
   

  	
   

  	
  Provisional

  	
   

  	
   

  	
   

  	
   

  
	
  P1801R1

  	
   

  	
  U.S./CIP

  	
   

  	
  09/602,530

  	
   

  	
  23-Jun-00

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  P1801R2

  	
   

  	
  U.S.

  	
   

  	
  09/811,123

  	
   

  	
  16-Mar-01

  	
   

  	
  16-Mar-00

  23-Jun-00

  05-Oct-00

  	
   

  	
  Pub. No. 2002-0001587 (1/3/02)

  	
   

  	
   

  	
   

  	
   

  
	
  P1801R1

  	
   

  	
  PCT

  	
   

  	
  PCT/US00/17229

  	
   

  	
  23-Jun-00

  	
   

  	
  25-Jun-99

  16-Mar-00

  	
   

  	
  Pub. No. WO 0100244 (1/4/01)

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  P1801R1

  	
   

  	
  Australia

  	
   

  	
  56329/00

  	
   

  	
  23-Jun-00

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  P1801R1

  	
   

  	
  Brazil

  	
   

  	
  PI0012196.7

  	
   

  	
  23-Jun-00

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  P1801R1

  	
   

  	
  Canada

  	
   

  	
  2370466

  	
   

  	
  23-Jun-00

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  P1801R1

  	
   

  	
  China

  	
   

  	
  811782.9

  	
   

  	
  23-Jun-00

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  P1801R1

  	
   

  	
  Europe

  	
   

  	
  941649.6

  	
   

  	
  23-Jun-00

  	
   

  	
   

  	
   

  	
  EP 1191944 A2 (1/4/01)

  	
   

  	
   

  	
   

  	
   

  
	
  P1801R1

  	
   

  	
  Hungary

  	
   

  	
  0201616

  	
   

  	
  23-Jun-00

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  P1801R1

  	
   

  	
  Israel

  	
   

  	
  147241

  	
   

  	
  23-Jun-00

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  P1801R1

  	
   

  	
  Japan

  	
   

  	
  505951/01

  	
   

  	
  23-Jun-00

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  P1801R1

  	
   

  	
  Korea

  	
   

  	
  10-2001-7016486

  	
   

  	
  23-Jun-00

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  P1801R1

  	
   

  	
  Mexico

  	
   

  	
  PA/a/2001/013240

  	
   

  	
  23-Jun-00

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  P1801R1

  	
   

  	
  New Zealand

  	
   

  	
  515975

  	
   

  	
  23-Jun-00

  	
   

  	
   

  	
   

  	
  51595

  	
   

  	
  10-May-04

  	
   

  	
  23-Jun-20

  
	
  P1801R1

  	
   

  	
  Poland

  	
   

  	
  P352678

  	
   

  	
  23-Jun-00

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  P1801R1

  	
   

  	
  So. Africa

  	
   

  	
  9768/01

  	
   

  	
  23-Jun-00

  	
   

  	
   

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  

 

A-2

 

PF4-4 STRAIN

(Mutant
Actinosynnema pretiosum strain with increased maytansinoid production)

 

	
  Atty. Ref. No.

  	
   

  	
  Country

  	
   

  	
  Appl. No.

  	
   

  	
  Filing Date

  	
   

  	
  Priority Date

  	
   

  	
  Patent No.

  	
   

  	
  Issue Date

  	
   

  	
  Expiry Date

  
	
  A8275

  	
   

  	
  U.S.

  	
   

  	
  10/057,561

  	
   

  	
  29-Jan-02

  	
   

  	
   

  	
   

  	
  6,790,954

  	
   

  	
  14-Sep-04

  	
   

  	
  29-Jan-22

  
	
  A8802

  	
   

  	
  U.S. (Div)

  	
   

  	
  10/898,169

  	
   

  	
  26-Jul-04

  	
   

  	
  29-Jan-02

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F163522

  	
   

  	
  PCT

  	
   

  	
  PCT/US03/00026

  	
   

  	
  15-Jan-03

  	
   

  	
  29-Jan-02

  	
   

  	
  Pub. No. WO 03/064610 A2 (8/7/03)

  	
   

  	
   

  	
   

  	
   

  
	
  F163501

  	
   

  	
  Australia

  	
   

  	
  20033238752

  	
   

  	
  15-Jan-03

  	
   

  	
  29-Jan-02

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F163502

  	
   

  	
  Canada

  	
   

  	
  No number yet

  	
   

  	
  15-Jan-03

  	
   

  	
  29-Jan-02

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F163503

  	
   

  	
  Europe

  	
   

  	
  03734944.6

  	
   

  	
  15-Jan-03

  	
   

  	
  29-Jan-02

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F163504

  	
   

  	
  Japan

  	
   

  	
  2003-564206

  	
   

  	
  15-Jan-03

  	
   

  	
  29-Jan-02

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F163521

  	
   

  	
  New Zealand

  	
   

  	
  532831

  	
   

  	
  15-Jan-03

  	
   

  	
  29-Jan-02

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  

 

METHODS FOR THE PRODUCTION OF ANSAMITOCINS (Fermentation Process)

 

	
  Atty. Ref. No.

  	
   

  	
  Country

  	
   

  	
  Appl. No.

  	
   

  	
  Filing Date

  	
   

  	
  Priority Date

  	
   

  	
  Patent No.

  	
   

  	
  Issue Date

  	
   

  	
  Expiry Date

  
	
  P8588

  	
   

  	
  U.S.

  	
   

  	
  60/468,638

  	
   

  	
  08-May-03

  	
   

  	
   

  	
   

  	
  Provisional

  	
   

  	
   

  	
   

  	
   

  
	
  A8588

  	
   

  	
  U.S.

  	
   

  	
  10/840,768

  	
   

  	
  07-May-04

  	
   

  	
  08-May-03

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F174522

  	
   

  	
  PCT

  	
   

  	
  PCT/US04/01300

  	
   

  	
  10-May-04

  	
   

  	
  08-May-03

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  

 

IMPROVED CYTOTOXIC AGENTS COMPRISING NEW MAYTANSINOIDS (DM4)

 

	
  Atty. Ref. No.

  	
   

  	
  Country

  	
   

  	
  Appl. No.

  	
   

  	
  Filing Date

  	
   

  	
  Priority Date

  	
   

  	
  Patent No.

  	
   

  	
  Issue Date

  	
   

  	
  Expiry Date

  
	
  P8576

  	
   

  	
  U.S.

  	
   

  	
  60/471,739

  	
   

  	
  20-May-03

  	
   

  	
   

  	
   

  	
  Provisional

  	
   

  	
   

  	
   

  	
   

  
	
  A8576

  	
   

  	
  U.S.

  	
   

  	
  10/849,136

  	
   

  	
  20-May-04

  	
   

  	
  20-May-03

  	
   

  	
  Pub. No. 2004/0235840 A1 (11/25/04)

  	
   

  	
   

  	
   

  	
   

  
	
  F177222

  	
   

  	
  PCT

  	
   

  	
  PCT/US04/013314

  	
   

  	
  20-May-04

  	
   

  	
  20-May-03

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  

 

DRUG CONJUGATE COMPOSITION (Formulation)

 

	
  Atty. Ref. No.

  	
   

  	
  Country

  	
   

  	
  Appl. No.

  	
   

  	
  Filing Date

  	
   

  	
  Priority Date

  	
   

  	
  Patent No.

  	
   

  	
  Issue Date

  	
   

  	
  Expiry Date

  
	
  LVM 219992

  	
   

  	
  U.S.

  	
   

  	
  60/470,550

  	
   

  	
  14-May-03

  	
   

  	
   

  	
   

  	
  Provisional

  	
   

  	
   

  	
   

  	
   

  
	
  LVM 228669

  	
   

  	
  U.S.

  	
   

  	
  10/846,129

  	
   

  	
  14-May-04

  	
   

  	
  14-May-03

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  LVM 228670

  	
   

  	
  PCT

  	
   

  	
  PCT/US04/15376

  	
   

  	
  14-May-04

  	
   

  	
  14-May-03

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  

 

SMCC CONJUGATES

(Maytansinoid conjugates with non-cleavable linkers)

 

	
  Atty. Ref. No.

  	
   

  	
  Country

  	
   

  	
  Appl. No.

  	
   

  	
  Filing Date

  	
   

  	
  Priority Date

  	
   

  	
  Patent No.

  	
   

  	
  Issue Date

  	
   

  	
  Expiry Date

  
	
  P8662

  	
   

  	
  U.S.

  	
   

  	
  60/509,901

  	
   

  	
  10-Oct-03

  	
   

  	
   

  	
   

  	
  Provisional

  	
   

  	
   

  	
   

  	
   

  
	
  A8662

  	
   

  	
  U.S.

  	
   

  	
  10/960,602

  	
   

  	
  08-Oct-04

  	
   

  	
  10-Oct-03

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F189422

  	
   

  	
  PCT

  	
   

  	
  PCT/US04/030917

  	
   

  	
  12-Oct-04

  	
   

  	
  10-Oct-03

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  

 

A-3

 

PEG LINKER

 

(Cytotoxic agents bearing a reactive
polyethylene glycol moiety, cytotoxic conjugates comprising polyethylene glycol
linking groups,

and methods of making and using the same)

 

	
  Atty. Ref. No.

  	
   

  	
  Country

  	
   

  	
  Appl. No.

  	
   

  	
  Filing Date

  	
   

  	
  Priority Date

  	
   

  	
  Patent No.

  	
   

  	
  Issue Date

  	
   

  	
  Expiry Date

  
	
  A8212

  	
   

  	
  U.S.

  	
   

  	
  10/024,290

  	
   

  	
  21-Dec-01

  	
   

  	
   

  	
   

  	
  6,716,821

  	
   

  	
  6-Apr-04

  	
   

  	
  21-Dec-21

  
	
  F159322

  	
   

  	
  PCT

  	
   

  	
  PCT/US02/25972

  	
   

  	
  10-Sep-02

  	
   

  	
  21-Dec-01

  	
   

  	
  Pub. No. WO 03/068144 A2 (8/21/03)

  	
   

  	
   

  	
   

  	
   

  
	
  F159301

  	
   

  	
  Australia

  	
   

  	
  2002332542

  	
   

  	
  10-Sep-02

  	
   

  	
  21-Dec-01

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F159302

  	
   

  	
  Canada

  	
   

  	
  2,462,085

  	
   

  	
  10-Sep-02

  	
   

  	
  21-Dec-01

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F159303

  	
   

  	
  Europe

  	
   

  	
  02806788.2

  	
   

  	
  10-Sep-02

  	
   

  	
  21-Dec-01

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F159304

  	
   

  	
  Japan

  	
   

  	
  2003-567329

  	
   

  	
  10-Sep-02

  	
   

  	
  21-Dec-01

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  F159321

  	
   

  	
  New Zealand

  	
   

  	
  529834

  	
   

  	
  10-Sep-02

  	
   

  	
  21-Dec-01

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  

 

NITRO-PYRIDYL LINKER

 

(Cross-linkers with high reactivity and
solubility and their use in the preparation of conjugates for targeted delivery
of small molecule

drugs)

 

	
  Atty. Ref. No.

  	
   

  	
  Country

  	
   

  	
  Appl. No.

  	
   

  	
  Filing Date

  	
   

  	
  Priority Date

  	
   

  	
  Patent No.

  	
   

  	
  Issue Date

  	
   

  	
  Expiry Date

  
	
  P8359

  	
   

  	
  U.S.

  	
   

  	
  60/403,652

  	
   

  	
  16-Aug-02

  	
   

  	
   

  	
   

  	
  Provisional

  	
   

  	
   

  	
   

  	
   

  
	
  A8359

  	
   

  	
  U.S.

  	
   

  	
  10/633,616

  	
   

  	
  05-Aug-03

  	
   

  	
  16-Aug-02

  	
   

  	
  Allowed (9/16/04)

  	
   

  	
   

  	
   

  	
   

  
	
  F171622

  	
   

  	
  PCT

  	
   

  	
  PCT/US03/22494

  	
   

  	
  05-Aug-03

  	
   

  	
  16-Aug-02

  	
   

  	
  Pub. No. WO 04/016801 A2 (2/26/04)

  	
   

  	
   

  	
   

  	
   

  

 

SYNERGY

(Compositions
and methods for treating cancer using immunoconjugates and chemotherapeutic
agents)

 

	
  Atty. Ref. No.

  	
   

  	
  Country

  	
   

  	
  Appl. No.

  	
   

  	
  Filing Date

  	
   

  	
  Priority Date

  	
   

  	
  Patent No.

  	
   

  	
  Issue Date

  	
   

  	
  Expiry Date

  
	
  104322.198

  	
   

  	
  U.S.

  	
   

  	
  09/671,995

  	
   

  	
  29-Sep-00

  	
   

  	
  10/01/99

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  104322.198WO

  	
   

  	
  PCT

  	
   

  	
  PCT/US00/26800

  	
   

  	
  29-Sep-00

  	
   

  	
  01-Oct-99

  	
   

  	
  Pub. No. WO 01/24763 (04/12/01)

  	
   

  	
   

  	
   

  	
   

  
	
  104322.198EP

  	
   

  	
  Europe

  	
   

  	
  970516.1

  	
   

  	
  29-Sep-00

  	
   

  	
  01-Oct-99

  	
   

  	
  Pub. No. 1229934 (08/14/02)

  	
   

  	
   

  	
   

  	
   

  
	
  104322.198JP

  	
   

  	
  Japan

  	
   

  	
  2001-527762

  	
   

  	
  04/01/02?

  	
   

  	
  01-Oct-99

  	
   

  	
  Pub. No. 2003-528034 (09/24/03)

  	
   

  	
   

  	
   

  	
   

  
	
  104322.198CA

  	
   

  	
  Canada

  	
   

  	
  2,385,528

  	
   

  	
  29-Sep-00

  	
   

  	
  01-Oct-99

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  
	
  104322.198AU

  	
   

  	
  Australia

  	
   

  	
  79885/00

  	
   

  	
  29-Sep-00

  	
   

  	
  01-Oct-99

  	
   

  	
  Allowed (6/17/04)

  	
   

  	
   

  	
   

  	
   

  
	
  104322.198HK

  	
   

  	
  Hong Kong

  	
   

  	
  3100743.7

  	
   

  	
  29-Jan-03

  	
   

  	
  01-Oct-99

  	
   

  	
  Pending

  	
   

  	
   

  	
   

  	
   

  

 

A-4

 

SCHEDULE
B

 

PROVISIONS
FOR SUPPLY AGREEMENTS

 

All
Supply Agreements will include:

 

[******************************************************************************************************

***************************************************].

 

[*****************************************************************************************************

**********************************************************************].

 

[*************************************************].

 

[*********************************************************************************].

 

[******************************************************************************************************

*******************************************************************************************************

*************************************].

 

[*******************************************************************************************************

**********************************************************************************].

 

[*******************************************************************************************************

********************************************************************************************************

**************************************************************************].

 

[*******************************************************************************************************

**********************************************************************************].

 

[*******************************************].

 

[********************************************************************************************************

****************************].

 

[*******************************************************************************************************

***********************************************************************************************].

 

[*******************************************************************************************************

******************************************************************].

 

B-1

 

SCHEDULE
C

 

CENTOCOR BACKGROUND TECHNOLOGY

 

[**************************]

 

C-1

 

SCHEDULE
D

 

ADVERSE EVENT REPORTING PROCEDURES FOR LICENSED
PRODUCT

 

[**************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

*****************************].

 

A.                                   DEFINITIONS

 

Capitalized terms in this
Appendix have the following meanings. 
Capitalized terms not defined in this Appendix shall have the meanings
assigned to them in the Agreement.

 

1.             [******************************************************************************************

**********************************************************************************************************

****.*******.]

 

(a)
[***************************************];

 

(b)
[***************************************];

 

(c) [******]; and

 

(d) [************].

 

The term [*************] also includes a [*******]
of [*************************] of the [*******].

 

2.                                       [***************************************]:

 

(a) [*********************];

 

(b)
[***************************************];

 

(c) [***************];

 

(d)
[***************************************]; or

 

(e)
[***************************************].

 

3.                                       [******************************************************];

 

D-1

 

4.             [*****************************************************************************************

**************************************************************************************************].

 

5.             [******************************************************************************************

**********************************************************************************************************

*********************].

 

B.                                     [***********************************]

 

1.             [******************************************************************************************

**********************************************************************************************************

******************].

 

2.             [******************************************************************************************

**********************************************************************************************************

**************].

 

3.             [******************************************************************************************

**********************************************************************************************************

***********].

 

4.             [******************************************************************************************

*********************************************************************************************************

***].

 

C.                                     [***********************]

 

1.             [*****************************************************************************************

*********************************************************************************************************

**************************************************************************].

 

2.                                       [**************************************************************************:

 

(a)             [**********************************************************************************

**********************************************************************************************************

**********************************************************************].

 

(b)             [**********************************************************************************

**********************************************************************************************************

*****].

 

D-2

 

D.                                    [******************************]

 

1.             [******************************************************************************************

***************************************************************].

 

2.             [******************************************************************************************

**********************************************************************************************************

***********************].

 

3.             [******************************************************************************************

**********************************************************************************************************

**************************************************************************].

 

4.             [******************************************************************************************

**********************************************************************************************************

*******].

 

5.             [******************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

******************************************].

 

6.             [******************************************************************************************

**********************************************************************************************************

********************************************************************].

 

7.             [******************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************].

 

8.             [******************************************************************************************

***********].

 

9.             [******************************************************************************************

**********************************************************************************************************

**************************************].

 

D-3

 

SCHEDULE
E

 

DISPUTE
RESOLUTION PROCEDURES

 

[**************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

***************************].

 

a.         [********************************************************************************************

**************************************].

 

b.         [********************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

****************************************************************************************].

 

c.         [********************************************************************************************

**********************************************************************************************************

*********************************************************************************].

 

d.         [********************************************************************************************

**********************************************************************************************************

***************].

 

e.         [********************************************************************************************

***********************************************

 

E-1

 

**********************************************************************************************************

**********].

 

f.         [********************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

*****************************].

 

g.         [********************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

*****************].

 

h.         [********************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

***************************************].

 

i.         [*********************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

*********

 

E-2

 

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

******************************************************************************************].

 

j.         [********************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

****************************************************************************************************].

 

k.         [********************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

******************************************************************************].

 

E-3

 

l.         [*********************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

*****************************************************************************].

 

m.         [********************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

****************].

 

n.         *********************************************************************************************

**********************************************************************************************************

**********************************************************************************************************

***************].

 

E-4

 

o.         [*********************************************************************************************

**********************************************************************************************************

*******************************************************************************************************].

 

p.         [********************************************************].

 

q.         [********************************************************************************************

***************].

 

r.         [********************************************************************************************

*************].

 

s.         [********************************************************************************************

*******************************].

 

E-5

 

SCHEDULE F

 

[*****************************************************]

 

[********************************************************************

******************************************************************:

 

(a)          [******************************************************]

[******************************************************]

[******************************************************]

[********************************************]

 

(b)         [******************************************************]

[******************************************************]

[*******]

 

(c)          [******************************************************]

[******************************************************]

[******************************************************]

[*********************************].

 

F-1

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00077-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00077-of-00352.parquet"}]]