Exhibit 10.1

 

Execution Copy

 

CLINICAL SUPPLY AGREEMENT

 

This Clinical Supply Agreement (the “Agreement”) is made and entered into as of
the date of the last signature written below (the “Effective Date”) by and
between ImmunoGen, Inc., a corporation organized under the laws of the
Commonwealth of Massachusetts, with its principal offices at 830 Winter Street,
Waltham, Massachusetts 02451, U.S.A. (“ImmunoGen”) and  Sicor Società Italiana
Corticosteroidi S.r.l (in abbreviated form, Sicor S.r.l., hereafter referred to
as “Sicor”), an Italian corporation with registered offices at Via Messina 38,
20154 Milan, Italy and principal offices at Via Terrazzano 77, 20017 Rho
(MI), Italy (Sicor and ImmunoGen together the “Parties”, each a “Party”).

 

WHEREAS under a certain Technology Transfer and Development Agreement between
ImmunoGen and Sicor effective as of November 12, 2004 and amended on June 21,
2006 and December 15, 2006 (the “Technology Transfer Agreement”) Sicor has
provided ImmunoGen with expertise, technical assistance and advice in connection
with the development of a fermentation process using an ImmunoGen strain for the
production of ansamitocin compounds, and of a chemical synthesis process for
conversion of certain of such compounds into maytansinoid derivatives; and

 

WHEREAS under a certain Scale-Up Agreement between the Parties effective 27
April 2007 (the “Scale-Up Agreement”), the aforementioned processes were
scaled-up by Sicor so as to be utilizable for the production of certain
maytansinoid derivative compounds at the industrial scale; and

 

WHEREAS under a certain letter agreement between ImmunoGen, Sicor and [***]
dated [***] (the [***]),[***] authorized [***] to [***] to [***] certain [***]
of [***] for certain limited [***] by [***] and subject to certain terms and
conditions;

 

WHEREAS, based on the practical experience and results obtained during the
aforementioned scale-up activities, ImmunoGen desires to have Sicor manufacture
DMx compounds (as defined below) to be used in clinical testing, development,
registration and regulatory approvals for marketing and sale of drug product(s),
and Sicor is willing to manufacture and supply such compounds to ImmunoGen, on
the terms and conditions herein;

 

NOW THEREFORE, in consideration of the foregoing premises and the mutual
covenants herein contained, the Parties hereby agree as follows:

 

1.     Definitions.  The following terms, whether used in the singular or
plural, will have the meanings set forth below. Other terms underlined elsewhere
in this Agreement shall have the meaning set out where underlined.

 

1.1.      “Affiliate” shall mean any entity directly or indirectly controlling,
controlled by or under common control with, a Party.  For purposes hereof, the
direct or indirect ownership of over fifty percent (50%) of the outstanding
voting securities of an entity, or the right to receive over fifty percent (50%)
of the profits or earnings of an entity shall be deemed to constitute control. 
Such other relationship as in fact results in actual control by an entity over
the management, business and affairs of another entity shall also be deemed to
constitute control for purposes of this definition.

 

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

 

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1.2.      “Ansamitocins” shall mean the various ansamitocin isomers produced by
the Actinosynnema pretiosum Strain, including but not limited to the following
compounds:

 

[***]

 

1.3.      “Applicable Law” means all federal, state, local, national and
supra-national laws, statutes, rules and regulations, including any rules,
regulations, guidelines or requirements of applicable Regulatory Authorities,
national securities exchanges or securities exchanges or securities listing
organizations that may be in effect from time to time during the term of this
Agreement and applicable to a particular activity hereunder.

 

1.4.      “Batch” means a specific quantity of Product produced during the same
cycle of Manufacture as defined by the applicable Batch Record.

 

1.5.      “Batch Record” means the specific documentation produced in connection
with the Manufacture of a particular Batch and/or lot.

 

1.6.      “Committed Quantities” has the meaning set forth in Sub-Paragraph
4.7.1.2.

 

1.7.      “cGMP” means the current good manufacturing practices applicable to
the Manufacture of Product pursuant to Applicable Law in effect in the European
Union and/or the United States of America as of the date of Manufacture of a
particular Batch of Product.

 

1.8.      “Clinical and Registration Production” shall mean fermentation and
chemical synthesis of DMx compounds for use in Drug Product(s) being developed
for and/or destined for use in clinical testing and/or for submitting and
obtaining approval of Health Registration(s) thereof, by or on behalf of
ImmunoGen or ImmunoGen Marketing Partners (all terms as defined below).

 

1.9.      “Clinical Trial” shall mean a human clinical trial conducted in any
country or countries in patients with a particular disease or condition with the
purpose of establishing the safety and tolerability of an investigational drug
and confirming or establishing its efficacy for such disease or condition.

 

1.10.    “Control” or “Controlled” means (a) with respect to any Technology,
Patent Rights or Confidential Information, the possession by a Party of the
right to grant a license or sublicense of such Technology, or Patent Rights or
disclose such Confidential Information as provided herein without breaching the
terms of any agreement between such Party and any Third Party and (b) with
respect to any proprietary materials, the possession by a Party of the right to
supply such proprietary materials to the other Party without breaching the terms
of any agreement between such Party and a Third Party.

 

1.11.    “DMx” shall mean all maytansinoid derivatives containing the maytansine
chemical substructure set forth in described in US Patent Nos. 5,208,020 (May 4,
1993) and 7,276,497 (October 2, 2007) including, but not limited to, the
following chemical compounds:

 

- DM1: N2’-deacetyl-N2’-(3-mercapto-1-oxopropyl)-maytansine, CAS#139504-50-0;

 

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

 

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- DM4: N2’-deacetyl-N2’-(4-mercapto-4-methyl-1-oxopentyl)-maytansine,
CAS#796073-69-3.

 

1.12.    “Drug Product” shall mean any finished drug product that is developed,
manufactured, marketed or sold by ImmunoGen or any Marketing Partner that
incorporates, is comprised of, or is derived from, DMx conjugated with an
antibody.

 

1.13.    “DSP Technologies” shall mean any Technology Controlled by [***] that
is necessary or useful for the [***] resulting from the use of the ImmunoGen
Fermentation Process Technologies.

 

1.14.    “Effective Date” shall have the meaning set out hereinabove.

 

1.15.    “Equipment” means any equipment or machinery used by Sicor in the
Manufacture of Product.

 

1.16.    “FDA” shall mean the U.S. Food and Drug Administration.

 

1.17.    “FDCA” means the United States Federal Food, Drug and Cosmetic Act, 21
U.S.C. §§321 et seq., as amended from time to time.

 

1.18.    “Force Majeure” has the meaning set forth in Section 12.1.

 

1.19.    “Health Registrations” shall mean the technical, medical and scientific
licenses, registrations, authorizations and/or approvals of Drug
Product(s) (including the prerequisite manufacturing approvals or authorizations
related thereto) that are required or deemed necessary by any Regulatory
Authority (including any national, supra-national (e.g., the European Commission
or the Council or the European Union), regional, state or local regulatory
agency, department, bureau or other governmental entity in the Territory),
necessary for the manufacture, distribution, use or sale of such Drug
Product(s) in the Territory, as they may be amended or supplemented from time to
time.  With respect to the United States, Health Registration shall include,
without limitation, any New Drug Application or Abbreviated New Drug Application
for the Drug Product(s), as amended or supplemented from time to time.

 

1.20.    “ImmunoGen Chemical Synthesis Technologies” shall mean any Technology
Controlled by ImmunoGen that is necessary or useful to conduct the chemical
synthesis process described by ImmunoGen to Sicor in its [***], any chemical
synthesis process developed under the Technology Transfer Agreement or the
Scale-Up Agreement (excluding in either case any [***]), or any other chemical
synthesis process agreed to by the Parties, with reactions steps starting from
[***] through the production of [***].

 

1.21.    “ImmunoGen Confidential Information” shall mean (a) the ImmunoGen
Technology (as defined below), (b) all other proprietary or confidential
information in relation to ImmunoGen’s general business operations, Technology
and products, and manufacturing processes and licensees and collaborative
partners which is disclosed to Sicor by or on behalf of ImmunoGen or its
Affiliates pursuant to this Agreement, and (c) all other information
specifically identified herein as ImmunoGen Confidential Information. Sicor
shall treat the terms of this Agreement, including without limitation the
pricing terms, as ImmunoGen Confidential Information.

 

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

 

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1.22.    “ImmunoGen Fermentation and DSP Technologies” shall mean, collectively,
the Strain, the ImmunoGen Fermentation Process Technologies and the DSP
Technologies.

 

1.23.    “ImmunoGen Fermentation Process Technologies” shall mean any Technology
Controlled by ImmunoGen that is necessary or useful to use the [***] to [***],
including all defined procedures, equipment and analytical methodologies for
in-process controls.

 

1.24.    “ImmunoGen Indemnitee” has the meaning set forth in Section 14.1.

 

1.25.    “ImmunoGen Materials” means (a) the Strain, and (b) any New Strain (as
defined in Section 7.6 below) transferred by ImmunoGen or by a Third Party on
ImmunoGen’s behalf to Sicor or purchased by Sicor on ImmunoGen’s behalf, in any
case for the purpose of conducting the activities contemplated by this
Agreement.

 

1.26.    “ImmunoGen Patent Rights” shall mean any Patent Rights Controlled by
ImmunoGen containing one or more claims that cover ImmunoGen Technology.

 

1.27.    “ImmunoGen Technology” shall mean, collectively, the ImmunoGen
Fermentation Process Technologies, the DSP Technologies and the ImmunoGen
Chemical Synthesis Technologies.

 

1.28.    “Losses” has the meaning set forth in Section 14.1.

 

1.29.    “Manufacture” and “Manufacturing” means any steps, processes and
activities necessary to produce Product, including without limitation, the
manufacturing, processing, quality control testing, release or storage of
Product.

 

1.30.    “Manufacturing Process” means any and all processes (or any step in any
process) used or planned to be used by Sicor to Manufacture Product, as
evidenced or referenced in the Master Batch Record and associated Records.

 

1.31.    “Marketing Partner” shall mean any Third Party that, prior to the
Effective Date or during the term of this Agreement, has or will have been
[***].  For purposes of this Agreement, any such Third Party shall cease to be a
Marketing Partner upon the [***].

 

1.32.    “Master Batch Record” means a written description of the Manufacturing
Process, reviewed and approved by ImmunoGen before Manufacturing commences,
which shall include all technical requirements and Manufacturing parameters with
regard to the Manufacturing methods.

 

1.33.    “Maytansinol” shall mean the maytansinoid derivative containing the
maytansine chemical substructure identified by CAS#57103-68-1.

 

1.34.    “Maytansinoid Products” shall mean DMx and any precursors of DMx
containing the maytansine chemical substructure, including, but not limited to,
Ansamitocins and Maytansinol.

 

1.35.    “Patent Rights” means the rights and interests in and to issued patents
and pending patent applications (including certificates of invention,
applications for certificates of invention and priority rights) in any country
or region, including all provisional applications,

 

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

 

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substitutions, continuations, continuations-in-part, divisionals, renewals, all
letters patent granted thereon, and all reissues, re-examinations and extensions
thereof, and all foreign counterparts of any of the foregoing.

 

1.36.    “Processing Time” has the meaning set forth in Sub-Paragraph 4.7.1.2.

 

1.37.    “Product” shall mean either DM1 or DM4; “Products” shall mean both DM1
and DM4.

 

1.38.    “Project Inventions” means any and all inventions, improvements,
discoveries, developments, original works of authorship, trade secrets, or other
Technology conceived, developed and/or reduced to practice, whether in whole or
in part, by Sicor in the performance of the activities contemplated by this
Agreement.  For purposes of this Agreement, “Sicor Project Inventions” means any
Project Inventions that are [***]; “Joint Restricted Project Inventions” means
any Project Inventions that that are [***]; “Joint Unrestricted Project
Inventions” means any Project Inventions that are [***] and “Joint Inventions”
means, collectively, all Joint Restricted Project Inventions and Joint
Unrestricted Project Inventions.

 

1.39.    “Quality Agreement” means the Quality Agreement of even date herewith
entered into by the Parties containing quality assurance provisions applicable
for the Clinical and Registration Production and, in general, Manufacturing to
be carried out under this Agreement.  A copy of the Quality Agreement is
attached hereto as Annex A.

 

1.40.    “Records” has the meaning set forth in Section 4.4.

 

1.41.    “Regulatory Authority” shall mean the applicable government regulatory
authority in any country in the Territory involved in granting the Health
Registrations for Drug Product or otherwise having authority over the
distribution, importation, exportation, manufacture, production, use, storage,
transport, clinical testing or sale of Drug Product.  Such term includes,
without limitation, the FDA, the Committee for Medicinal Products for Human Use
(CHMP) within the European Union and the national medicines agencies of
countries within the European Union, and any successors thereto.

 

1.42.    “Reprocess” and “Reprocessing” means repeating step(s) that are part of
the Manufacturing Process in order to cause Product that does not conform to
Specifications to conform to Specifications.

 

1.43.    “Rework” and “Reworking” means performing step(s) that are not part of
the Manufacturing Process in order to cause a Product that does not conform to
applicable standards or Specifications to conform to those standards or
Specifications.

 

1.44.    “Rolling Forecast” has the meaning set forth in Paragraph 4.7.1.

 

1.45.    “Sicor Confidential Information” shall mean all data and information
regarding any Sicor Project Inventions or regarding any compounds produced by or
for Sicor or any of its Affiliates outside the performance of the activities
contemplated by this Agreement, or any intermediates, raw materials or
impurities utilized or produced by or for Sicor or any of its Affiliates in
manufacturing such compounds, or any degradation products deriving therefrom,
including but not limited to processes for the synthesis or production of any of
such

 

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

 

5

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substances, testing and analytical methodology and data relative to such
substances, equipment, and sources of supply, and concerning any Sicor or Sicor
Affiliate cost, price and volume information, business plans, and production
capabilities regarding any product of Sicor or of a Sicor Affiliate, that are,
in any case, Controlled by Sicor and disclosed or supplied to ImmunoGen by or on
behalf of Sicor pursuant to this Agreement.  ImmunoGen shall treat the terms of
this Agreement, including without limitation the pricing terms (subject to
Section 13.8), as Sicor Confidential Information.

 

1.46.    “Sicor Facilities” means the facilities of Sicor located at Rho, Italy
and/or Santhià, Italy.

 

1.47.    “Sicor Indemnitee” has the meaning set forth in Section 14.2.

 

1.48.    “Specifications” mean the specifications and the quality control
testing procedures for each of the Products, as set forth in the Quality
Agreement, or as otherwise agreed to by the Parties in writing.

 

1.49.    “Strain” shall mean ImmunoGen’s proprietary Actinosynnema pretiosum
strain, with the properties and characteristics set forth in [***].

 

1.50.    “Supply Partner” shall mean any Marketing Partner with respect to which
ImmunoGen has agreed to supply such Marketing Partner with one or more
Maytansinoid Product(s) ordered by such Marketing Partner.

 

1.51.    “Technology” shall mean, collectively, know-how, inventions, trade
secrets, and proprietary information and methods, including without limitation,
methods of production or use of, and structural and functional information
pertaining to, chemical compounds and all data, formulations processes and
results.

 

1.52.    “Territory” shall mean the entire world.

 

1.53.    “Third Party” means any person or entity other than Sicor, ImmunoGen,
and their respective Affiliates.

 

2.     Implementation of Scaled-up Process.

 

2.1.      Each Party will appoint a “Technical Contact” having primary
responsibility for day-to-day interactions with the other Party for the Clinical
and Registration Production.  Any change to a Technical Contact will be
identified in writing to the other Party.  Each Party will use reasonable
efforts to provide the other Party with at least thirty (30) days  prior written
notice of any change in that Party’s Technical Contact.  Except for notices or
communications required or permitted under this Agreement, which shall be
subject to Section 16.3 below, all communications between Sicor and ImmunoGen
regarding the conduct of the Clinical and Registration Production will be
addressed to the Party’s relevant Technical Contact.

 

2.2.      The Parties will hold project team meetings via teleconference or in
person, on a periodic basis as agreed by the Technical Contacts.

 

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

 

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2.3.      The Parties shall establish a Joint Steering Committee (the “JSC”)
comprised of an equal number of representatives designated by each Party (which
number shall not be less than two (2) nor more than five (5)).  The Technical
Contacts shall report to the JSC.  Notwithstanding the foregoing, the Technical
Contacts may be members of the JSC.

 

2.3.1.             Each Party will be free to replace its representative members
on the JSC after using reasonable efforts to provide the other Party with at
least thirty (30) days prior written notice of any change in the JSC.

 

2.3.2.             The JSC shall be responsible for overseeing and directing the
Parties’ interaction and the performance of their respective obligations under
this Agreement.  Without limiting the generality of the foregoing, its duties
include:

 

·             Monitoring the performance of the activities contemplated by this
Agreement;

 

·    Resolving disagreements that arise under this Agreement; and

 

·    Determining the need and terms of any change orders.

 

2.3.3.             The JSC shall meet at such times as the JSC determines to
resolve issues arising hereunder and to perform its responsibilities under this
Agreement.  Such meetings may be in person or by telephone as agreed by the
JSC.  To the extent that meetings are held in person, they shall alternate
between the offices of the Parties unless the Parties agree otherwise.  The
Technical Contacts shall attend all meetings of the JSC.  All decisions of the
JSC shall be unanimous.

 

2.3.4.             The chairperson of the JSC shall be designated every year on
an alternate basis between the Parties.  The chairperson shall be responsible
for calling meetings, sending notices of meetings, and for leading such
meetings.

 

2.3.5.             In the event that the JSC cannot reach agreement with respect
to any material issue, then such dispute shall be resolved in accordance with
Section 16.4 below.

 

2.3.6.             The JSC is not empowered to amend the terms of this
Agreement.

 

2.4.      Sicor may subcontract the performance of certain of its obligations
under this Agreement to qualified Affiliates and/or Third Parties pursuant to
section 3.3 of the Quality Agreement.

 

3.     Clinical and Registration Production.

 

3.1.      During the term of this Agreement and subject to the terms and
conditions of Sub-Paragraphs 4.7.1.2, 4.7.2.2 and 4.7.2.5, Sicor shall
Manufacture and supply to ImmunoGen ImmunoGen’s good faith requirements of
Product ordered by ImmunoGen for all Clinical Trials of Drug Product to be
carried out by or for ImmunoGen and its Supply Partners for the submission of
Health Registrations thereof in the Territory and, in general,

 

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

 

7

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for use in Drug Product(s) being developed for and/or destined for use in
clinical testing and/or for submitting and obtaining approval of Health
Registration(s) thereof, pursuant to the terms and conditions of articles 4, 5,
6, and 7 and other applicable provisions of this Agreement.

 

3.2.      During the term of this Agreement and as long as Sicor is able to
Manufacture (including the [***] provisions of Section 4.8) and supply Product
in a timely manner, pursuant to Section 4.7, with the objective of providing
ImmunoGen with sufficient quantities of Product to meet ImmunoGen good faith
requirements as described in Section 3.1, ImmunoGen agrees to purchase from
Sicor all its requirements of Product for Clinical Trials of Drug Product(s) to
be carried out by or for ImmunoGen or its Supply Partners, and for submitting
and obtaining approval of Health Registration(s) thereof in the Territory, and,
in general, for use in Drug Product(s) being developed for and/or destined for
use in clinical testing and/or for submitting and obtaining approval of Health
Registration(s) thereof. For purposes of this Section 3.2, including Paragraph
3.2.2, and of Section 11.2 hereof, Sicor will be deemed to have Manufactured and
supplied Product in a timely manner when (i) Product and AP3 or Maytansinol
[***] has been Manufactured, and AP3 or Maytansinol, respectively, converted to
Manufactured Product, pursuant to and in accordance with the provisions of
Sub-Paragraphs 4.7.1.2, 4.7.2.2 and 4.7.2.5 and Section 4.8 hereof, and
(ii) Product is supplied by Sicor within [***] days of the delivery date set
forth in the Purchase Orders provided in accordance with such provisions.

 

3.2.1.             Notwithstanding the foregoing, with respect to the
requirements of ImmunoGen’s Supply Partners, this Section shall apply only to a
Supply Partner’s requirements [***].

 

3.2.2.             Upon any failure by Sicor to Manufacture and supply Product
in a timely manner, ImmunoGen shall thereafter be entitled to obtain from one or
more of its Affiliates or Third Parties the quantities of Product in question.

 

3.3.      All Clinical and Registration Production shall be carried out in
accordance with the provisions of the Quality Agreement.

 

3.4.      Sicor shall be responsible and shall carry out any Product licensure
and any other regulatory filings that are required for the clinical testing and
submissions described in Section 3.2, and is responsible to ensure that all of
such filings with Regulatory Authorities are consistent with the Specification,
the Master Batch Record and the Quality Agreement.  Such licensure and filings
shall not be deemed to require Sicor to [***], unless agreed to by the Parties
in respect of or under the Specification, the Master Batch Records or the
Quality Agreement, which agreement shall be the subject of one or more separate
writings. The respective regulatory responsibilities of Sicor and ImmunoGen as
to such filings and Product to be Manufactured hereunder are set forth in the
Quality Agreement.

 

4.     Manufacture and Supply of Product.

 

4.1.      Sicor will Manufacture Product at the Sicor Facilities. The foregoing
shall not preclude Sicor’s right to subcontract certain Manufacturing activities
to qualified Affiliates or Third Parties at other sites and facilities pursuant
to Section 2.4 hereof. For the purpose having two alternative sites available
for the downstream chemistry processing of AP3 into

 

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

 

8

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Product to be supplied to ImmunoGen hereunder as contemplated in Appendix III of
the Quality Agreement, Sicor agrees to have both of the Sicor Facilities
qualified and utilizable for such purpose, in accordance with the relevant
provisions the Quality Agreement. Furthermore, Sicor may otherwise propose to
change the location from one of the Sicor Facilities to the other, or use any
additional facility controlled by Sicor or its Affiliates for the Manufacture of
Product, pursuant to the terms of the Quality Agreement and in any event only
upon (a) providing ImmunoGen with written notice of such proposal at least [***]
days commencing any of the preparatory steps necessary to qualify such other
facility for such activities, and (b) receiving ImmunoGen’s prior written
consent, which consent will not be unreasonably withheld or delayed.  The
Parties agree that it will be reasonable for ImmunoGen to withhold such consent
pending satisfactory completion by each of the Parties of their respective
quality assurance audits and/or regulatory impact assessments of the new
location or additional facility, as the case may be.  Sicor will maintain, at
its own expense, the Sicor Facilities (and any additional facility approved for
use as described above) and all Equipment required for the Manufacture of
Product in a state of repair and operating efficiency consistent with the
requirements of cGMP and Applicable Law.

 

4.2.      Any change or modification to the Manufacturing Process or
Specifications for any Product must be carried out in accordance with the
provisions of the Quality Agreement (if applicable).

 

4.3.      Sicor will take and retain, for such period and in such quantities as
may be required by cGMP and the Quality Agreement, samples of Product from the
Manufacturing Process produced under this Agreement.  Further, Sicor will submit
such samples to ImmunoGen, upon ImmunoGen’s written request.

 

4.4.      Sicor will keep complete and accurate records, including, without
limitation, reports, accounts, notes, data, and records of all information and
results obtained from performance of the Manufacturing activities contemplated
by this Agreement, including without limitation, all documents listed in section
5.2.2 of the Quality Agreement  (such documents referred to as the “Records”). 
All Records will be will be treated by Sicor as ImmunoGen Confidential
Information.  Upon ImmunoGen’s request, Sicor will promptly provide ImmunoGen
with copies of such Records.  Sicor will not transfer, deliver or otherwise
provide any such Records to any party other than ImmunoGen, without the prior
written approval of ImmunoGen, provided that (a) Sicor may provide the necessary
parts of Records to any Regulatory Authority without ImmunoGen consent to the
extent required for compliance or abidance with Applicable Laws, and (b) [***]. 
While in the possession or control of Sicor, Records will be made available for
inspection, examination and copying by or on behalf of ImmunoGen.  All original
Records of the Manufacture of Product hereunder will be retained and archived by
Sicor in accordance with cGMP and Applicable Law, and according to its
applicable procedures. Sicor will not destroy the Records without first giving
ImmunoGen written notice and the opportunity for ImmunoGen to receive the
Records at ImmunoGen’s expense.

 

4.5.      Subcontracting.  To the extent ImmunoGen gives its consent, which
consent shall not be unreasonably withheld or delayed, Sicor shall have the
right to grant a sublicense under any ImmunoGen Technology and/or to grant a
license to use of its interest in any Joint Inventions, and provide ImmunoGen
Confidential Information, to subcontractors used pursuant to Section 2.4 hereof,
but solely as may be necessary for such Affiliate or Third

 

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

 

9

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Party subcontractor to perform the subcontracted activities. Sicor shall take
reasonable steps to insure that any such sublicense is carried out in a manner
that sufficiently protects ImmunoGen intellectual property rights and
Confidential Information which shall include, without limitation, entering into
agreements with each such Affiliate or Third Party subcontractor reasonably
acceptable to ImmunoGen that includes obligations of confidentiality and non-use
comparable to those set forth herein applicable to Sicor.  Any and all
activities performed by any such subcontractor shall be at Sicor’s sole cost and
expense.

 

4.6.      Use of ImmunoGen Materials.  In connection with all ImmunoGen
Materials supplied by ImmunoGen to Sicor under this Agreement, Sicor hereby
agrees that (a) it shall not use such ImmunoGen Materials for any purpose other
than exercising any rights granted to it hereunder (except that Sicor may use
the ImmunoGen Materials for the purpose of manufacturing and supplying Product
to ImmunoGen’s Marketing Partners so long as they remain Marketing Partners);
(b) it shall use such ImmunoGen Materials only in compliance with all applicable
national, regional, and local laws and regulations; (c) it shall not transfer
such ImmunoGen Materials to any Affiliate or Third Party without the prior
written consent of ImmunoGen, which consent shall not be withheld where
necessary for the subcontracting activities consented to by ImmunoGen pursuant
to Section 2.4; (d) it shall maintain all such ImmunoGen Materials in storage
under its control in the Sicor Facilities, using commercially reasonable efforts
to keep such ImmunoGen Materials secure and safe from loss and damage in such
manner as Sicor stores materials of a similar nature and in accordance with
reasonable storage guidelines provided by ImmunoGen, in such a way as to be able
to distinguish the same from products and materials belonging to Sicor or held
by Sicor for a Third Party; (e) ImmunoGen shall retain full ownership of all
such ImmunoGen Materials; and (f) upon the expiration or termination of this
Agreement, Sicor shall at the instruction of ImmunoGen either destroy or return
any unused ImmunoGen Material.

 

4.7.      Forecasts and Purchase Orders.

 

4.7.1.             Rolling Forecasts.  Starting with the forecast set out in
Annex B, and thereafter at least [***] prior to the start of each [***] during
the term of this Agreement, ImmunoGen shall submit to Sicor a good-faith rolling
written forecast of the total quantity of Products estimated to be required for
the [***] commencing with such [***], based on the then-current grams of Product
per Batch being produced by Sicor, substantially in the form of Annex C attached
hereto (each a “Rolling Forecast”).  In each Rolling Forecast, ImmunoGen shall
include a breakdown of the total quantity of Products and the number of Batches
of each to be made by [***].  In the event that ImmunoGen expects to require in
any [***] more or less than multiples of whole Batches of Product, then it shall
state this requirement, specifying any quantities of Product required additional
to the number of, or instead of, any whole Batches to be supplied.

 

4.7.1.1.            The [***] of each Rolling Forecast shall be binding, as to
the quantities and/or number of Batches forecast. Except for the binding nature
of the [***] as set forth hereinbelow, the Parties acknowledge that each Rolling
Forecast shall otherwise be non-binding and that factors including, but not
limited to, the number of clinical studies conducted, clinical enrollment and
Product yields may affect the accuracy of such Rolling Forecasts.  ImmunoGen may
amend any

 

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

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

 

10

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

 

portion of the [***] of each Rolling Forecast to the extent not already covered
by a Purchase Order (as defined below), so as to account for such variables, in
a subsequent Rolling Forecast containing such amended portion in the first
quarter.

 

4.7.1.2.     Sicor shall not be obliged to supply any quantities of Product set
out in any Rolling Forecast which would exceed, for the applicable [***],
(i) the amounts of Product required to be [***] as described in Section 4.8
hereof, based on the [***] terms stated therein, plus (ii) the amounts that
would be [***], based on a [***] processing time (the “Processing Time”) and
always pursuant to the [***] terms stated therein (amounts of Product in (i) and
(ii) collectively, the “Commitment Quantities”).  Within [***] of the submission
to Sicor by ImmunoGen of each Rolling Forecast, Sicor shall deliver to ImmunoGen
a written notice stating that portion of such Rolling Forecast beyond the
Commitment Quantities it believes it cannot supply in the designated [***]
applicable to such portions, and shall inform ImmunoGen of its first available
manufacturing slot for such quantities.

 

4.7.2.             Purchase Orders.

 

4.7.2.1.          ImmunoGen shall deliver to Sicor, together with each Rolling
Forecast, a written binding purchase order (each, a “Purchase Order”) for the
amount of Products which ImmunoGen wishes to order to be made during the [***]
covered by such Rolling Forecast.

 

4.7.2.2.          ImmunoGen may also issue Purchase Orders for Product at other
times, provided that each such Purchase Orders shall always be issued to Sicor
(i) in accordance with the timing established for Sicor having available
Commitment Quantities and (ii) with regards to any quantities of Product to be
Manufactured from [***], at least [***] prior to the requested delivery date for
Product. Notwithstanding the foregoing, and the provisions of Sub-Paragraph
4.7.2.1, the first Purchase Orders delivered to Sicor under this Agreement, and
all subsequent Purchase Orders until [***] pursuant to the provisions of
Paragraph 4.8.3 hereof, shall be issued by ImmunoGen at least [***] prior to the
requested delivery date for Product. In the event that ImmunoGen issues Purchase
Orders with shorter lead times, or inconsistent with the timing established for
having available Commitment Quantities, Sicor shall be under no obligation to
fulfill such Purchase Orders, although it may do so pursuant the following
provisions. Sicor shall also have no obligation to accept or fulfill any
Purchase Orders, whether under this or the previous Sub-Paragraphs, for any
delivery quantity of less than [***] of Product.

 

4.7.2.3.          At least [***] prior to issuance of any Purchase
Order, ImmunoGen shall also send Sicor’s Technical Contact information as to
quantities, delivery dates and other pertinent information regarding the planned
Purchase Order, so as to allow Sicor to propose alternative timing and
modalities of Product supply which ImmunoGen will be under no

 

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

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

 

11

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

 

obligation to accept to the extent that such alternative timing and modalities
fail to conform to the terms of this Agreement.

 

4.7.2.4.          Each Purchase Order shall specify: (a) the total quantity of
Product which ImmunoGen assumes would be supplied with such Purchase Order; and
(b) the requested time and location for delivery of each Batch.  Notwithstanding
the foregoing, if ImmunoGen requires more or less than multiples of whole
Batches of Product, rather than (a) and (b) ImmunoGen shall specify in the
Purchase Order that it is requesting a specific quantity of Product (which
specific quantity shall be in increments of [***]. Notwithstanding the
foregoing, ImmunoGen may also request in Purchase Orders, and Sicor agrees to
supply, a quantity of Product smaller than [***], but solely to the extent that
such quantity is the full residual amount remaining in any Batch after all
previous orders of [***] quantities. Sicor shall not, in any event, be required
to fulfill any Purchase Order for any quantities of less than [***] of Product,
provided that such lesser quantity of Product may be supplied if the Parties can
reach agreement on appropriate pricing for such lesser quantity.

 

4.7.2.5.          Sicor shall provide ImmunoGen with prompt written notice of
its acceptance of each such Purchase Order.  Sicor shall have the right to
reject any purchase quantities within any Purchase Order to the extent that such
quantities are inconsistent with the timing established for having available
Commitment Quantities, or when the Purchase Order provides for a shorter lead
time than that set forth in Sub-Paragraph 4.7.2.2. In such cases, Sicor shall
provide ImmunoGen with a notice of such inconsistencies and/or shorter lead
time, and rejection within [***] after its receipt of the applicable Purchase
Order, it being agreed that any Purchase Order, or portion thereof, which is not
timely rejected shall be deemed to have been accepted.  Sicor shall Manufacture
and supply ImmunoGen with Products in quantities sufficient to fulfill accepted
Purchase Orders.

 

4.7.3.             Cancellations.  ImmunoGen may cancel, no more than [***] per
[***], by providing prompt written notice of same (a “Cancellation Notice”) to
Sicor.  With respect to any Batch or Batches which are the subject of a
Cancellation Notice, the following shall apply:

 

4.7.3.1.          Before Initiation. If ImmunoGen gives Cancellation Notice
prior to Sicor’s initiating the Manufacture of any such cancelled Batch(es), the
cancellation shall be effective upon Sicor’s receipt of such notice, and Sicor
shall immediately cease all work and cancel all outstanding permitted
subcontracts associated therewith.  If that cancellation occurs less than [***]
prior to the agreed-to date for the start of the production of such Batches,
then ImmunoGen shall pay to Sicor an amount equal to [***] (assuming each such
cancelled Batch would have produced [***] of Product set forth in the
then-current Master Batch Record).  By way of clarification, in the event the
Sicor Activity constitutes production of one or more Batches and that
cancellation

 

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

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

 

12

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

 

occurs more than [***] prior to the agreed-to date for the start of the
production of such Batches, then ImmunoGen shall not pay to Sicor any amounts
associated with the cancelled Batch(es) other than the [***].

 

4.7.3.2.          After Initiation.  In the event that ImmunoGen provides Sicor
a Cancellation Notice after Sicor has initiated production of one or more of
such cancelled Batch(es), Sicor shall, as applicable, conclude the production of
the then-current production stage (Ansamitocin, Maytansinol or Product) of the
cancelled Batch(es) in accordance with the applicable order.  With respect to
those cancelled Batch(es) that were commenced, unless otherwise agreed by the
Parties, Sicor shall, as directed by ImmunoGen, deliver, offer for sale (on
terms to be agreed by the Parties), store or destroy such Batch(es), and
ImmunoGen shall pay Sicor an amount equal to [***] if the product to be
manufactured from such Batch(es) hereunder is an Ansamitocin, [***] if the
product to be manufactured from such Batch(es) hereunder is Maytansinol and
[***] if the product to be manufactured from such Batch(es) hereunder is DMx (in
each case assuming each such cancelled Batch would have produced [***] of
Product set forth in the then-current Master Batch Record). With respect to
those cancelled Batch(es), if any, that were not commenced ImmunoGen shall pay
to Sicor an amount, if any, in accordance with Section 4.7.3.1 above.

 

4.8.      [***].  Throughout the term of this Agreement, Sicor shall [***] of

 

·      [***] sufficient to [***]; and

 

·      Between [***] and [***] of [***], as specified in Paragraph 4.8.2; and

 

·      Between [***] and [***] of [***], as specified in Paragraph 4.8.2.

 

4.8.1.     Sicor shall be allowed at least [***] to [***] after any [***] is
[***] therefrom to [***] for ImmunoGen.

 

4.8.2.     Sicor shall not be required to [***] until and unless, in each case,
such [***] below the [***]. Upon such [***], Sicor shall be allowed at least
[***] to [***], as the case may be, to the [***], by [***] one or more [***], as
applicable, which would result in having at least [***], as the case may be, but
no more than [***], as the case may be, in the [***].

 

4.8.3.     From the Effective Date of the Agreement, Sicor shall be allowed
[***] to create the [***].

 

4.8.4.     ImmunoGen agrees to [***] (i) all [***] pursuant to this section 4.8,
and (ii) all [***] pursuant to this section 4.8, at least [***] prior to the
[***] relative to [***], so that all [***] will be [***] and supplied to
ImmunoGen in such manner, such obligation to survive expiration or termination
of this Agreement.

 

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

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

 

13

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

 

5.     Product and Process Acceptance.

 

5.1.      Any Product to be Manufactured hereunder will be Manufactured in
accordance with the Manufacturing Process, the Quality Agreement and cGMP.  Each
Batch of Product will be sampled and tested by Sicor against the Specifications.
The quality assurance department of Sicor will review the Batch Record for such
Batch and will assess if the Manufacture has taken place in compliance with cGMP
and the Manufacturing Process.  It is the Parties’ mutual objective that Product
shall be [***]; provided, however, that Sicor (Sub-Paragraph 4.7.2.4 hereof
notwithstanding) shall continue the practice as of the Effective Date of
providing [***] of Product to ImmunoGen until ImmunoGen successfully completes
development work enabling it to [***] at its facility.

 

5.2.      Sicor shall only release Product for delivery to ImmunoGen if, based
upon the aforementioned tests, a Batch of Product conforms to the Specifications
and was Manufactured according to cGMP and the Manufacturing Process, and then
only subsequent to the Record approval procedure set out in the last two
paragraphs of Section 5.1 of the Quality Agreement.

 

5.3.      During such Record approval procedure, ImmunoGen may also test samples
of such Batch against the Specifications.  In such case, ImmunoGen will notify
Sicor in writing of its acceptance or rejection of such Batch within the term
set forth in Section 5.6 of the Quality Agreement for completion of said
procedure.  ImmunoGen has no obligation to accept a Batch if the Batch does not
comply with the Specifications and/or was not Manufactured in compliance with
cGMP and with the Manufacturing Process.

 

5.4.      If the Parties disagree as to whether a Batch of Product conforms to
the applicable Specifications, the Parties will then attempt to resolve any such
disagreement in good faith and ImmunoGen and Sicor will follow their respective
standard operating procedures to determine the conformity of the Batch of
Product to cGMP, the Manufacturing Process and to the Specifications. If the
Parties are not able to resolve such disagreement within [***] of the end of the
aforementioned Record approval procedure term, then either Party may use the
dispute resolution mechanism set forth in Section 5.7.1 of the Quality Agreement
in the event the disagreement regards conformity of the Batch to the
Specifications, or any other applicable dispute mechanism or procedure
contemplated in this Agreement or the Quality Agreement for other cases of
non-conformity.

 

5.5.      If, following the Record approval procedure contemplated under
Section 5.2 and, if applicable, the dispute resolution procedures referenced in
Section 5.4, it is agreed or determined that a Batch of Product fails to conform
to the Specifications or was not Manufactured in compliance with cGMP and the
Manufacturing Process, then Sicor will, at ImmunoGen’s sole option:

 

5.5.1.             [***]; or

 

5.5.2.             [***]; or

 

5.5.3.             [***].

 

Moreover, the Parties will meet to discuss, evaluate and analyze the reasons for
and implications of the failure to comply with cGMP and/or the Manufacturing
Process.

 

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

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

 

14

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

 

6.     Shipping and Delivery.

 

6.1.      Shipping will be in accordance with reasonable instructions for
shipping and packaging specified by ImmunoGen in writing or as otherwise agreed
to in writing by the Parties. Delivery terms are [***].  A bill of lading will
be furnished to ImmunoGen with respect to each shipment.

 

6.2.      ImmunoGen will promptly notify Sicor in writing of loss, damage,
defects or non-delivery of any part of a Product shipment after delivery of such
shipment to ImmunoGen, or its designee, but in any event no later than [***]
after delivery or, if in case any defects are not evident to ImmunoGen at the
time of delivery, such notification by ImmunoGen to Sicor will be made no later
than [***] after discovery thereof and in any event no later than [***] after
delivery.

 

7.     Price and Payments.

 

7.1.      The Parties agree that the pricing for orders covering at least one
full Batch of Product supplied under this Agreement shall be [***], subject to
Section 7.4 below, or such lesser amount determined on a [***] basis as mutually
agreed upon by the Parties.

 

Although, based on production experience of Sicor prior to execution of the
present Agreement, it is expected that the quantities of Product produced per
Batch may be in the range of about [***] to [***], any different values will not
in any way, be deemed contrary to the parties’ intent or a breach of this
Agreement, and shall not effect the above prices or any of the other terms or
conditions of this Agreement).

 

7.2.      Sicor will invoice ImmunoGen according to the above schedule, or as
otherwise contemplated under this Agreement, for Clinical and Registration
Production of Product.  Payment of invoices will be due [***] after receipt
thereof the invoice by ImmunoGen.  ImmunoGen will make all payments in Euros and
by check or wire transfer to a bank account designated in writing by Sicor.

 

7.3.      Duty, sales, use or excise taxes imposed by any governmental entity
that apply to the provision of Clinical and Registration Production or
Manufacture and supply of Product hereunder (other than any taxes based upon the
income of Sicor) will be borne by ImmunoGen. In particular, all payments due
hereunder are deemed to be net of VAT and any other applicable taxes or duties,
which shall be paid by ImmunoGen.

 

7.4.      Notwithstanding the pricing otherwise set out in Section 7.1, Sicor
agrees that ImmunoGen shall [***], as described in the following sentences of
this Section 7.4, for all orders of quantities of Product equal to at least one
full production Batch (i.e., [***]).  For purposes of clarity, at any time
during the term of this Agreement should Sicor have [***], or as otherwise then
in effect pursuant to this Section 7.4, then ImmunoGen’s [***] shall be
immediately [***] as follows: For each [***], the [***] shall be [***] in a
[***], until the [***].  Such [***] shall then [***].  For purposes of clarity,
the Batches of Product purchased under the [***] shall be included in
determining [***] in accordance with this Section 7.4.

 

7.5.      Sicor shall keep complete and accurate records of [***], and [***], to
all [***] in sufficient detail to allow ImmunoGen to verify and enforce its
rights under Section 7.4 above as follows.  ImmunoGen shall have the right,
during the term of this Agreement and

 

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

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

 

15

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

 

for a period of one (1) year after expiration or termination of this Agreement,
to appoint an independent auditor reasonably acceptable to Sicor to examine the
relevant records for such purpose.  Such examination shall be conducted, and
Sicor shall make its records available, during ordinary working hours at the
Sicor Facility located in Rho, Italy, no more than [***], on a reasonably
acceptable date no earlier than [***] after written notice has been provided by
ImmunoGen to Sicor.  Before permitting such independent auditor to have access
to such records, Sicor may require such independent auditor to sign a
confidentiality agreement (in form and substance reasonably acceptable to both
Parties) as to any confidential information which is to be provided to such
independent representative or to which such independent representative will have
access while conducting its examination contemplated hereby.  The independent
representative shall provide both Parties with a written report stating solely
whether ImmunoGen has received [***] to which it is entitled hereunder and the
specific amounts of any discrepancies.  Such independent representative may not
reveal to ImmunoGen any information learned in the course of such examination
other than the [***].  ImmunoGen agrees to hold in strict confidence all
information disclosed to it in accordance with Section 13 hereof, except to the
extent necessary for ImmunoGen to enforce its rights under this Agreement or if
disclosure is required by law.  [***] shall pay for such examinations, except
that, in the event an examination reveals an [***] of at least [***] of the
overall amounts subject to such verification, [***] shall pay for such
examination.

 

7.6.      The Parties agree that the pricing set forth in Section 7.1 is based
on [***] in connection with the Manufacturing Process.  Subject to acceptance by
all then current Marketing Partners that are procuring Product from
Sicor, ImmunoGen may subsequent to initiating the Commercial Supply contemplated
in the following Article 8, at its option, elect to have Sicor [***] which is
intended to result in [***] and consequent [***] to the Manufacturing Process. 
The Parties shall agree upon a mutually acceptable work plan to enable Sicor to
use the [***] in the Manufacturing Process, and shall negotiate in good faith
the [***] manufactured for ImmunoGen thereafter.

 

8.     Commercial Supply

 

8.1.      At least [***] prior to the expected completion of the first [***]
involving a Drug Product for which Sicor supplied the Product to ImmunoGen
hereunder, the Parties shall begin good faith negotiations for a commercial
supply agreement regarding the manufacture, purchase and supply of such quantity
of DMx compounds as may be required for commercialization of such Drug Product
substantially on the terms set forth in APPENDIX 7 to the Technology Transfer
Agreement (on pricing terms as set forth in Section 7.1 of this Agreement (as
may be [***]) or as otherwise agreed upon).  ImmunoGen recognizes and agrees
that, as the [***] of [***] and [***] active pharmaceutical ingredients to the
[***] and [***], and as long as it remains such, [***] shall have the right to
[***], and [***], for the [***]; provided, however, that in no event shall
ImmunoGen be required to agree to the Manufacture of Product at any facility
other than the [***].  In any such agreement, Sicor [***] shall, in any event,
have the [***] of all such required quantities of the DMx compounds.  In
connection therewith, the Parties shall negotiate in good faith for a period of
[***] with respect to the terms and conditions of such agreement, including
specification of price and quantity terms.  If the Parties are unable to agree
upon the terms and conditions of such agreement within such [***] period,
then Sicor [***] shall [***].  If ImmunoGen does not [***], ImmunoGen shall
thereafter have the right to pursue such supply, including the right to
negotiate with, and grant rights to, any ImmunoGen

 

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

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

 

16

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

 

Affiliate or Third Party with respect to such manufacture and supply, but only
on terms that are [***], taking into account all factors deemed reasonably
relevant by ImmunoGen.  ImmunoGen will inform Sicor [***] and, to the extent
[***], ImmunoGen will [***] that ImmunoGen has determined is [***] as described
above and Sicor [***] shall have [***] to provide written notice to ImmunoGen as
to whether it is willing to enter into an agreement with ImmunoGen [***].  If
Sicor [***] fail to provide written notice within such [***], ImmunoGen’s
obligations under this Section 8.1 shall terminate.  If Sicor [***] provide such
written notice within such [***], the Parties, [***], will negotiate and execute
a commercial supply agreement which shall contain [***].

 

8.2.      ImmunoGen shall inform Sicor promptly upon execution of any such
agreement with an Affiliate or Third Party having [***] as described in
Section 8.1.  Sicor [***] shall subsequently have the right, upon reasonable
notice to ImmunoGen solely to the extent provided to ImmunoGen on or before
[***] from the date of Sicor’s receipt of such notice from ImmunoGen, to
designate an independent representative reasonably acceptable to ImmunoGen to
have access, during ordinary working hours to ImmunoGen’s premises and to such
records as may be necessary to verify that ImmunoGen has granted any such
manufacture and supply rights to an Affiliate or Third Party in compliance with
Section 8.1; provided, that, to the extent requested by ImmunoGen, such Sicor
[***] representative shall enter into a confidentiality agreement with ImmunoGen
reasonably acceptable to ImmunoGen.  Such representative (i) shall not have
access to any information relating to the business of ImmunoGen except that
which is reasonably necessary for such representative to confirm compliance with
Section 8.1, and (ii) shall, in any event, only disclose to Sicor [***] whether
or not ImmunoGen is in compliance with Section 8.1 and shall under no
circumstances disclose to Sicor [***] the actual terms of such agreement.

 

9.     Representations and Warranties.

 

9.1.      Sicor represents and warrants that:

 

9.1.1.             The Clinical and Registration Production will be performed
with requisite care, skill and diligence, in accordance with Applicable Law,
industry standards and this Agreement, and by individuals who are appropriately
trained and qualified.

 

9.1.2.             At the time of delivery to ImmunoGen, the Product
Manufactured under this Agreement (i) will have been Manufactured in accordance
with cGMP and Applicable Law, the Manufacturing Process, and the Specifications,
and (ii) will not be adulterated or misbranded under the FDCA or other
Applicable Law.

 

9.1.3.             Neither Sicor, its officers nor any person used by Sicor to
perform Clinical and Registration Production (i) has been debarred, or
convicted, or is subject to a pending debarment or conviction, pursuant to
section 306 of the FDCA, 21 U.S.C. § 335a or (ii) has been listed by any federal
or state agencies, excluded, debarred, suspended or otherwise been made
ineligible to participate in federal and/or state healthcare programs or federal
procurement or non-procurement programs (as that term is defined in 42 U.S.C.
1320a-7b(f)) or (iii) has been convicted of a criminal offense related to the
provision of healthcare

 

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

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

 

17

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

 

items or services, or is subject to any such pending action. Sicor agrees to
inform ImmunoGen in writing immediately if Sicor or any person who is performing
Clinical and Registration Production is subject to the foregoing, or if any
action, suit, claim, investigation, or proceeding relating to the foregoing is
pending, or to the best of Sicor’s knowledge, is threatened.

 

9.2.      ImmunoGen represents and warrants that:

 

9.2.1.             To the best of ImmunoGen’s knowledge, the use of ImmunoGen
Technology as contemplated herein will not infringe the intellectual property
rights of any Third Party and ImmunoGen will promptly notify Sicor in writing
should it become aware of any claims asserting such infringement.

 

9.3.      [***]

 

10.   Compliance With Government Regulations and other Applicable Law.

 

10.1.    Sicor agrees to comply with all Applicable Law in performing Clinical
and Registration Production.  Sicor will be responsible for obtaining, at its
expense, any necessary licenses or permits for the activities contemplated
hereunder, and any regulatory and government approvals necessary therefor.
ImmunoGen will be solely responsible for carrying out or having carried out all
Clinical Trials and submitting all Drug Product Health Registration applications
in respect to any Product supplied hereunder, in accordance with all Applicable
Law.

 

10.2.    ImmunoGen will be responsible for obtaining, at its expense, all
regulatory and governmental approvals and permits necessary for ImmunoGen’s use
of any Product Manufactured hereunder.  Sicor will be responsible for providing
ImmunoGen with all supporting data and information in its possession relating to
the Manufacture of Product requested by ImmunoGen for obtaining such approvals. 
The format of such data and information for submission by ImmunoGen to a
regulatory agency will be agreed in advance by the Parties.

 

10.3.    Sicor will permit ImmunoGen and/or its representatives (which may
include representatives of [***], always subject to prior binding of such [***]
to confidentiality obligations as set forth in Paragraph 13.2.3) to be present
and participate in any visit or inspection by any Regulatory Authority of the
Sicor Facilities (to the extent it relates in any way to any Product or to the
Manufacturing Process).  Sicor will give as much advance notice as possible to
ImmunoGen of any such visit or inspection.  Sicor will provide to ImmunoGen a
copy of any report or other written communication received from any Regulatory
Authority within [***] after receipt thereof, and will consult with and require
approval from, ImmunoGen before responding to each such communication.  Sicor
will provide ImmunoGen with a copy of its final responses within [***]
submission thereof.

 

10.4.    The generation, collection, storage, handling, transportation, movement
and release of hazardous materials and waste generated in connection with the
Clinical and Registration Production and Manufacture will be the responsibility
of Sicor at Sicor’s sole cost and expense.  Sicor will prepare, execute and
maintain, as the generator of waste, all documentation required under Applicable
Law.

 

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

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

 

18

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

 

10.5.    Sicor will be solely responsible for implementing and maintaining
health and safety procedures for the performance of Clinical and Registration
Production. Sicor, in consultation with ImmunoGen, will develop safety and
handling procedures for Product; provided, however, that ImmunoGen will have no
responsibility for Sicor’s health and safety program.

 

10.6.    In the case of recalls of ImmunoGen Drug Product that incorporates, is
comprised of, or is derived from, DMx Manufactured by Sicor, [***] shall bear
all reasonable costs associated with the performance of a recall of Drug Product
(i) only in respect of the disposition and replacement of the affected DMx
material; (ii) only if [***] was informed and involved with [***] from the start
of in discussions on an eventual recall such, and (iii) only if [***] has been
determined to be the sole responsible party for the recall due to out of
specification DMx which could not have been recognized as such by the release
activities of [***] contemplated under the Quality Agreement.

 

11.   Term and Termination.

 

11.1.    This Agreement will take effect as of the Effective Date and, unless
earlier terminated pursuant to this Section, will continue in effect for seven
(7) years from the Effective Date, and shall be automatically renewed for
additional periods of one (1) year unless either Party gives the other written
termination notice at least one (1) year prior to any renewal date.
Notwithstanding the foregoing, if any Clinical Trials for a Drug Product have
begun but have not been completed prior to expiration, this Agreement will
expire upon such Clinical Trials having been either abandoned or completed (with
the relative submission(s) set forth in Section 3.1 hereof).  Anything contained
in this Agreement to the contrary notwithstanding, either Party may terminate
this Agreement in respect of any DMx compound upon [***] prior written notice to
the other Party at any time following the execution of any commercial supply
agreement entered into by ImmunoGen for such compound in accordance with the
provisions of Section 8 hereof.

 

11.2.    Termination for Force Majeure.  If it becomes apparent to either Party
at any time during the term of this Agreement that it will not be possible for
Sicor to carry out its obligations and responsibilities hereunder, including,
without limitation, the timely manufacture and supply of Product to ImmunoGen,
as a result of Force Majeure (as described in Section 12.1 below), where such
condition continues for a period of [***], the Parties shall permit [***] for
discussion to resolve, if possible, the Force Majeure issue giving rise to the
problem.  If the Parties fail to resolve the problem within this [***] period,
either Party shall have the right to terminate this Agreement, effective upon
written notice to the other.

 

11.3.    ImmunoGen will have the right, in its sole discretion, to terminate
this Agreement upon [***] prior written notice to Sicor if it ceases on a
permanent basis the Phase III Clinical Trials and submission(s) contemplated in
Sections 3.1 and 3.2 hereof.  ImmunoGen may also terminate this Agreement upon
[***] prior written notice to Sicor if Sicor materially breaches this Agreement
and fails to cure the breach during the notice period.

 

11.4.    Sicor may terminate this Agreement upon [***] prior written notice to
ImmunoGen if ImmunoGen materially breaches this Agreement and fails to cure the
breach during the notice period.

 

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

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

 

19

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

 

11.5.    Upon termination or expiration of this Agreement, neither Sicor nor
ImmunoGen shall have any further obligations under this Agreement, except that:

 

11.5.1.           Sicor will terminate (where applicable) all Clinical and
Registration Production or Manufacture of Product in progress, including
subcontracted Clinical and Registration Production, [***], unless ImmunoGen
specifies in the notice of termination that [***];

 

11.5.2.           Sicor will deliver to ImmunoGen all [***] in recorded form
that was provided by ImmunoGen, that are [***]. Notwithstanding the foregoing,
Sicor shall be allowed to retain such [***] as are required for Sicor to [***]
and/or [***] for [***], pursuant to and under the [***] for such purpose;

 

11.5.3.           ImmunoGen (i) will [***], (ii) [***], and (iii) may either
(x) purchase any other Product ordered by ImmunoGen in process held by Sicor as
of the date of the termination, at a price to be mutually agreed (it being
understood that such price will reflect, on a pro rata basis, work performed and
non-cancelable out-of-pocket expenses actually incurred by Sicor with respect to
the Manufacture of such in-process Product), or (y) reimburse Sicor for such
price and direct Sicor to dispose of such material at ImmunoGen’s cost;

 

11.5.4.           Each Party will immediately return the other Party’s
Confidential Information; and

 

11.5.5.           Any rights and obligations of the Parties that by their terms
survive termination or expiration of this Agreement, including, without
limitation, representations and warranties (Article 8), retention of property
for use for Marketing Partners (Section 11.5.2), confidentiality (Article 13),
indemnification (Article 14), and intellectual property rights (Article 15)
provisions of this Agreement, will survive termination or expiration.
Termination of this Agreement shall not effect any rights and obligations of the
Parties under the Technology Transfer Agreement.

 

12.           Force Majeure.

 

12.1.    Except as otherwise expressly set forth in this Agreement, neither
Party will have breached this Agreement for failure or delay in fulfilling or
performing any term of this Agreement other than for payments of money, when
such failure or delay is caused by or results from causes beyond the reasonable
control of the affected Party, including, without limitation, fire, floods,
embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be
declared or not), insurrections, riots, civil commotion, strikes, acts of God or
acts, omissions, or delays in acting, by any governmental authority (“Force
Majeure”).  The Party affected by any event of Force Majeure will promptly
notify the other Party, explaining the nature, details and expected duration
thereof.  Such Party will also notify the other Party from time to time as to
when the affected Party reasonably expects to resume performance in whole or in
part of its obligations hereunder, and to notify the other Party of the
cessation of any such event.  A Party affected by an event of Force Majeure will
use its reasonable efforts to remedy, remove, or mitigate such event and the
effects thereof with all reasonable dispatch.  If a Party anticipates that an
event of Force Majeure may occur, such Party will

 

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

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

 

20

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

 

notify the other Party of the nature, details and expected duration thereof.
Subject to Section 11.2 above, upon termination of the event of Force Majeure,
the performance of any suspended obligation or duty will promptly recommence.

 

13.         Confidentiality.

 

13.1.            ImmunoGen Confidential Information. Sicor shall not disclose
ImmunoGen Confidential Information to any person other than

 

13.1.1.          Sicor employees or employees of affiliated companies of the
Sicor group who are bound by similar obligations of confidentiality and who have
a need to know such information in connection with Sicor’s performance of the
activities contemplated by this Agreement;

 

13.1.2.          Marketing Partners, solely to the extent required in order to
develop, register, manufacture, market and sell such Marketing Partners DMx;
provided that such Marketing Partners must first be bound to substantially
similar obligations of confidentiality, restricted use and restricted disclosure
as those undertaken by Sicor under this Agreement;

 

13.1.3.          Regulatory Authorities, solely to the extent required in order
to implement or carry out the present Agreement and the Quality Agreement, and
the activities contemplated under such agreements;

 

13.1.4.          in respect solely to the disclosure of the terms of this
Agreement, other persons who are bound by similar obligations of confidentiality
and who have a need to know such information in connection with any actual or
potential [***].

 

13.2.            Sicor Confidential Information. ImmunoGen shall not disclose
any Sicor Confidential Information to any person other than:

 

13.2.1.                                  its employees or consultants who are
bound by substantially similar obligations of confidentiality and who have a
need to know such information in connection with ImmunoGen’s exercise of its
rights and performance of its obligations hereunder;

 

13.2.2.                                  Regulatory Authorities, solely to the
extent required in order to implement or carry out the present Agreement and the
Quality Agreement, and the activities contemplated under such agreements,
including, without limitation, the development and commercialization of Drug
Products;

 

13.2.3                                     its Marketing Partners, solely to the
extent required in order to enable such Marketing Partners to disclose such
information to Regulatory Authorities in connection with their development and
commercialization of Drug Products; provided that such Marketing Partners must
first be bound to substantially similar obligations of confidentiality,
restricted use and restricted disclosure as those undertaken by ImmunoGen under
this Agreement. ImmunoGen shall identify all Marketing Partners to Sicor, and
shall inform Sicor when such Third Parties cease to be Marketing Partners
pursuant to Section 1.31;

 

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

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

 

21

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

 

13.2.4.                                  its legal, accounting and financial
advisors who are bound by similar obligations of confidentiality and who have a
need to know such information in connection with their performance of services
for ImmunoGen; or

 

13.2.5.                                  in respect solely to the disclosure of
the terms of this Agreement, other persons who are bound by similar obligations
of confidentiality and who have a need to know such information in connection
with any actual or potential [***].

 

13.3.            Exceptions. The obligations of confidentiality applicable to
ImmunoGen Confidential Information and Sicor Confidential Information shall not
apply to any information that is:

 

13.3.1.                                  known publicly or becomes known
publicly through no fault of the recipient;

 

13.3.2.                                  obtained or acquired by the recipient
from a Third Party entitled to disclose it;

 

13.3.3.                                  developed by the recipient
independently of information obtained from the disclosing Party [***];

 

13.3.4.                                  already known to the recipient before
receipt from the disclosing Party, [***];

 

13.3.5.                                  required to be disclosed by law,
regulation or the order of a judicial or administrative authority, provided,
that, the recipient notifies the disclosing Party immediately upon receipt of
any such order or becoming aware of any such law or regulation, and provided,
that, such exception applies only so as to allow such disclosure in such manner;
or

 

13.3.6.                                  released with the prior written consent
of the disclosing Party.

 

13.4.            Joint Inventions. Information, data and/or know-how relative to
the Joint Inventions shall be used by the parties only in a manner that will not
be prejudicial to the potential Patent Rights with respect of such Joint
Inventions as established in Article 15 hereof.

 

13.5.            Treatment and Handling of Confidential Information.  Both
ImmunoGen and Sicor shall use reasonable and customary precautions to safeguard
ImmunoGen Confidential Information and Sicor Confidential Information, and
information and data regarding Joint Inventions, including ensuring that all
employees or consultants who are provided access to such information are
informed of the confidential and proprietary nature of such information and
understand that all such information is required to be maintained confidential.

 

13.6.            Others. No right or license under any patent or proprietary
right is granted hereunder by virtue of the disclosure of ImmunoGen Confidential
Information or Sicor Confidential Information except as expressly provided
herein.

 

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

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

 

22

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

 

13.7.            Supply Partners.  Anything contained in this Agreement to the
contrary notwithstanding, ImmunoGen shall be permitted to disclose [***], solely
to the extent that such disclosure is necessary for the negotiation or
determination of Product supply prices in the relative Product agreement(s) with
such potential or actual Supply Partners; and provided that such potential or
actual Supply Partners are first identified to Sicor and bound by similar
obligations of confidentiality.  The identity of any Third Party as a Supply
Partner shall be deemed to be ImmunoGen Confidential Information.

 

14.         Indemnification.

 

14.1.            Sicor will indemnify and hold harmless ImmunoGen, its
Affiliates and their respective officers, directors, employees and agents (each
a “ImmunoGen Indemnitee”) from and against any and all losses, damages,
liabilities or expenses (including reasonable attorneys fees and other costs of
defense) (collectively, “Losses”) in connection with any and all actions, suits,
claims or demands that may be brought or instituted against any ImmunoGen
Indemnitee by any Third Party [***], any (a) [***] by Sicor of its
representations, warranties or covenants hereunder, or (b) [***] act or omission
or the willful misconduct of any Sicor Indemnitees (as defined in Section 14.2
below) in performing obligations under this Agreement, except in each case to
the extent any such Losses are based on, arise out of or result from a [***] by
ImmunoGen of its representations, warranties or covenants hereunder or the [***]
act or omission or the willful misconduct of an ImmunoGen Indemnitee in
performing obligations under this Agreement.  As a condition of this
indemnification obligation, ImmunoGen must [***].  Notwithstanding the
foregoing, Sicor will not agree to settle any claim on such terms or conditions
as would [***] ImmunoGen’s ability or right to Manufacture, market, sell or
otherwise use Product, or as would [***] Sicor’s ability, right or obligation to
perform its obligations hereunder.

 

14.2.            ImmunoGen will indemnify and hold harmless Sicor, its
Affiliates and their respective officers, directors, employees and agents (each
a “Sicor Indemnitee”) from and against any and all Losses in connection with any
and all actions, suits, claims or demands that may be brought or instituted
against any Sicor Indemnitee by any Third Party [***] (a) the use of the
ImmunoGen Material, Product, or any other Maytansinoid Product produced by Sicor
for ImmunoGen, including but not limited to use in any Clinical Trial(s) and/or
Health Registration(s), except to the extent that such damages are within the
scope of the indemnification obligation of Sicor under Section 14.1, (b) [***]
by ImmunoGen of its representations, warranties or covenants hereunder, or
(c) any [***] act or omission or the willful misconduct of any ImmunoGen
Indemnitees in performing obligations under this Agreement, except in each case
to the extent such Losses are based on, arise out of or result from a [***] by
Sicor of its representations, warranties or covenants hereunder or the [***] act
or omission or the willful misconduct of a Sicor Indemnitee in performing
obligations under this Agreement. As a condition of this indemnification
obligation, Sicor must [***], must [***], and must [***].

 

14.3.            [***].

 

15.         Intellectual Property Rights.

 

15.1.            General. All intellectual property rights and other rights of a
proprietary nature subsisting in a Party prior to the Effective Date or that are
purchased, licensed, or conceived

 

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

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

 

23

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

 

and reduced to practice by a Party after the Effective Date but outside of the
conduct of the Project shall remain with and be solely owned or where
applicable, Controlled by that Party and nothing in this Agreement shall be
deemed to be a license to such intellectual property or proprietary rights even
if used in the performance of this Agreement.  Without limiting the foregoing,
as between the Parties (a) ImmunoGen shall have sole and exclusive ownership of
all right, title and interest in and to all ImmunoGen Technology, ImmunoGen
Patent Rights and ImmunoGen Confidential Information and (b) Sicor shall have
sole and exclusive ownership of all Sicor Confidential Information. Both Parties
shall treat the other Party’s intellectual property, including any Project
Inventions, in a confidential manner, so as to maintain the proprietary nature
and to avoid prejudice to possible patentability thereof.

 

15.2.            Specific Provisions.

 

15.2.1.                                  Disclosure; Ownership. [***] shall
promptly and fully disclose to [***] any and all Project Inventions.  All Joint
Inventions shall be [***] owned by [***].  [***] hereby agree that (i) as [***]
of Joint Unrestricted Project Inventions, [***] may use or license or sublicense
to any Affiliate or Third Party all such rights for any or all purposes without
restriction and without any obligation to account to [***], and is hereby
granted by [***] an irrevocable, royalty-free right under its interest in any
Joint Unrestricted Project Inventions to use, license or sublicense any such
Joint Unrestricted Project Inventions and (ii) notwithstanding anything to the
contrary contained herein or under Applicable Law, (A) [***] shall have the
right to use [***] in Joint Restricted Project Inventions, and [***] hereby
grants [***] a royalty-free, non-exclusive license under [***] in Joint
Restricted Project Inventions, solely for the performance of processing,
manufacturing, purifying and testing Maytansinoid Products for, and supplying
Maytansinoid Products to, [***] and [***] and (B) under no circumstances shall
[***] (1) use its interest in, or practice the above license under, Joint
Restricted Project Inventions for any other purpose or (2) grant a license to
any Third Party under [***] in Joint Restricted Project Inventions, or grant a
sublicense to any Third Party under the above license to Joint Restricted
Project Inventions, for any purpose except as provided for under Section 2.3. 
The Parties agree that, [***] Joint Restricted Project Inventions, [***] may use
or license or sublicense to any Affiliate or Third Party all such rights for any
and all purposes without restriction and without any obligation to account to
[***], and [***] is hereby granted by [***] an irrevocable, royalty-free right
under [***]in any Joint Restricted Project Inventions to use, license or
sublicense any such Joint Restricted Project Inventions.

 

The Parties acknowledge that, with the exception of works of authorship solely
covering [***], all original works of authorship made by Sicor within the scope
of the services it provides in accordance with the Project are “works made for
hire,” as that term is defined in the United States Copyright Act (17 U.S.C. §
101).  Without prejudice to any retention rights it may otherwise have
hereunder, Sicor further agrees that upon completion or termination of this
Agreement, Sicor will turn over to ImmunoGen, or make such disposition thereof
as may be directed or approved by ImmunoGen, any data or information acquired or
completed by Sicor in carrying out the terms of this Agreement other than works
of authorship solely covering Sicor Project Inventions.

 

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

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

 

24

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

 

15.2.2.                                  Retained Rights.  Notwithstanding
anything to the contrary in this Agreement (a) all Technology or other
intellectual property, including any derivative works related thereto, which
(i) [***] owns or acquires from any Third Party as of the Effective Date, or
(ii) [***] creates or acquires outside of its performance of the activities
contemplated by this Agreement and (b) any [***], in each case, will remain the
sole and exclusive property of [***] and [***] shall have no rights thereto.
[***] acknowledges that no license or other rights, other than as specifically
set forth in this Agreement, are granted to [***] under this Agreement with
respect to any Patent Rights or Technology of [***].

 

15.2.3.                                  [***].  As between the Parties, [***]
shall own all right, title and interest in and to the [***].

 

15.3.            Patent Filings. For any Patent Rights or potential Patent
Rights with respect to Joint Project Inventions (“Joint Project Patent Rights”),
[***] shall have the sole right to determine when and where patent applications
are to be filed, subject to the following, and shall be responsible for all
filings, prosecutions and maintenance of such applications, using patent counsel
of its choice, and any patents issuing therefrom, and for all payments relative
thereto (in such case, [***] referred to as the “Filing Party”).  [***] shall
undertake to file Joint Project Patent Rights in the name of [***].  For Joint
Restricted Project Inventions, [***] use of such Joint Project Patent Rights
shall in any event be restricted as set forth in Paragraph 15.2.1 hereof.  If
[***] in its sole discretion decides to abandon or not to pursue any of the
Joint Project Patent Rights in any country or region, [***] shall inform [***]
of such decision promptly.  If [***] requests in writing that [***] permit it to
assume responsibility for beginning or continuing the prosecution of any such
Joint Project Patent Rights, or which [***] has otherwise failed to file, pursue
or maintain, then, subject to the following proviso, [***] shall have the right
to assume such responsibility and pay any required fees to prosecute or maintain
such Joint Project Patent Rights in such country and defend such Joint Project
Patent Rights, in each case at [***] sole expense (in such case, [***] referred
to as the “Filing Party”).  With respect to any such Patent Rights or potential
Patent Rights which have not been published, [***] shall have such right to
assume such responsibilities solely to the extent that [***] consents to such
request (which consent may withheld in its sole discretion), [***] use of such
Joint Project Patent Rights shall remain subject to the restrictions set forth
in Paragraph 15.2.1 of this Agreement.

 

15.4.            Cooperation.  Each Party agrees to cooperate with the other
Party to the fullest extent possible in respect of the filing, prosecution,
obtaining and maintenance of any patent, provisional patent or other similar
protection in respect of all Joint Project Patent Rights.  If any patent filing
or prosecution of, or grant of a sublicense under, any Joint Project Patent
Rights in any country requires co-inventors of jointly invented technology to
execute any document or agreement or take any other action, the Parties agree to
cooperate with each other, including without limitation by executing such
document or agreement, and/or taking such other action, at its sole expense, to
ensure the ability of [***] to freely practice such Joint Project Patent Rights
and of [***] to use its interest in such rights as described above.

 

15.5.            Third Party Infringement.

 

15.5.1.                                  In the event either Party becomes aware
of any possible infringement of any Joint Project Patent Rights (an
“Infringement”), that Party

 

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

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

 

25

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

 

shall promptly notify the other Party and provide it with all details of such
Infringement of which it is aware (each, an “Infringement Notice”).  [***] shall
have the sole right to eliminate such Infringement by reasonable steps, which
may include the institution of legal proceedings or other action.  All costs,
including without limitation attorneys’ fees, relating to such legal proceedings
or other action shall be borne by [***].  [***] shall have the right to settle
any Infringement claim or proceeding under this Section without the prior
written consent of [***].

 

15.5.2.                                  In any action, suit or proceeding
instituted under this Section, the Parties shall cooperate with and assist each
other in all reasonable respects.  Upon the reasonable request of [***], [***]
shall join such action, suit or proceeding and shall be represented using
counsel of its own choice, at [***] expense.

 

15.5.3.                                  Any amounts recovered by [***] pursuant
to this Section 15.5, whether by settlement or judgment, shall be allocated in
the following order: (i) first, to reimburse the parties for their reasonable
out-of-pocket expenses in making such recovery (which amounts shall be allocated
pro rata if insufficient to cover the totality of such expenses); and (ii) then,
[***] to [***].

 

15.6.            License. Without prejudice to any other rights granted to Sicor
under this Agreement or under Technology Transfer Agreement or the Scale-Up
Agreement, ImmunoGen hereby grants to Sicor a non-exclusive, royalty-free right
and license, during the term of this Agreement, to use ImmunoGen Confidential
Information and ImmunoGen Technology and ImmunoGen’s interest in Joint
Inventions, for the sole purpose of enabling Sicor to carry out its tasks and
responsibilities under this Agreement.  Such license shall not include the right
to sublicense (except as specifically set forth in Section 4.5 hereinabove).

 

16.         Miscellaneous.

 

16.1.            Assignment.  This Agreement may not be assigned or otherwise
transferred by either Party without the prior written consent of the other
Party; provided, however, that either Party may, without such consent, but with
notice to the other Party, assign this Agreement, in whole or in part, (a) in
connection with the transfer or sale of all or substantially all of the assets
of such Party or the line of business or Product to which this Agreement
relates, (b) to the successor entity or acquiror in the event of the merger,
consolidation or change of control of a Party hereto, or (c) to any Affiliate of
the assigning Party, provided that the assignee shall have agreed in writing to
assume all of the assignor’s obligations hereunder, and provided, further, that
any such assignment shall be subject to prior notification to the other Party. 
Any such assignment shall not relieve the assigning Party of any liabilities or
obligations owed to the other Party hereunder.  Any purported assignment in
violation of this Section will be void.

 

16.2.            Severability.  If any provision of this Agreement becomes or is
declared by a court of competent jurisdiction to be illegal, unenforceable or
void, this Agreement will continue in full force and effect without said
provision.  If any provision of this Agreement is held to be excessively broad,
it will be reformed and construed by limiting and reducing it so as to be
enforceable to the maximum extent permitted by law.  The Parties will use their

 

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

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

 

26

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

 

reasonable efforts to replace the invalid, illegal or unenforceable
provision(s) with valid, legal and enforceable provision(s), which, insofar as
practical, implement the intent of the Parties.  The foregoing will not apply to
provisions relating to price and payment hereunder.

 

16.3.            Notices.  All notices or other communications which are
required or permitted hereunder will be made in writing and delivered
personally, sent by telecopier (and promptly confirmed by personal delivery,
registered or certified mail or overnight courier), sent by
nationally-recognized overnight courier or sent by registered or certified mail,
postage prepaid, return receipt requested, addressed as follows:

 

If to Sicor, to:

 

If to ImmunoGen, to:

 

 

 

Sicor S.r.l.

 

ImmunoGen Inc.

Via Terrazzano 77

 

830 Winter Street

20017 Rho (MI), Italy

 

Waltham, MA 02451 USA

Attention: Managing Director

 

Attention: Chief Financial Officer

Telecopier No.: [***]

 

Telecopier No.: [***]

 

with a copy to:

Attention: Legal Department

 

or to such other address as the Party to whom notice is to be given may have
furnished to the other Party in writing. Any such communication will be deemed
to have been given (a) when delivered, if personally delivered or sent by
telecopier on a business day, (b) on the [***] after dispatch, if sent by
nationally-recognized overnight courier, or (c) on the [***] following the date
of mailing, if sent by first class mail.

 

16.4.            Choice of Law; Disputes.  This Agreement will in all events and
for all purposes be governed by, and construed in accordance with, the laws of
the State of New York without regard to any choice of law principle that would
dictate the application of the law of another jurisdiction.

 

16.4.1.                                  Negotiation.  The Parties recognize
that a bona fide dispute as to certain matters may from time to time arise
during the term of this Agreement that relates to either Party’s rights and/or
obligations hereunder.  In the event of the occurrence of such a dispute, other
than that which is contemplated under Section 5.4 hereof, either Party may, by
written notice to the other Party, have such dispute referred to their
respective senior officials designated below or their successors, for attempted
resolution by good faith negotiations within [***] after such notice is
received.  Said designated senior officials are as follows:

 

For ImmunoGen:                           Chief Executive Officer

 

For Sicor:                Managing Director

 

16.4.2.                                  Arbitration.  Subject to Section 5.4
and Paragraph 16.4.1 above, all disputes arising in connection with the present
Agreement or otherwise between the Parties hereto with regards to the activities
contemplated by this Agreement shall be finally settled under the Rules of
Conciliation and Arbitration of the International Chamber of Commerce by three
arbitrators appointed in

 

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

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

 

27

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

 

accordance with said rules.  Language of the arbitration shall be [***].  Place
of arbitration shall be [***], if arbitration is brought by [***] and shall be
[***] if arbitration is brought by [***].  Notwithstanding the foregoing, either
Party shall have the right, without waiving any right or remedy available to
such Party under this Agreement or otherwise, to seek and obtain from any court
of competent jurisdiction any interim or provisional relief that is necessary or
desirable to protect the rights and property of such Party, pending the
selection of the arbitrators hereunder or pending the arbitrators’ determination
of any dispute, controversy or claim hereunder.

 

16.5.            Entire Agreement; Amendment.  Except for the Quality Agreement
and for any provisions still applicable of [***], the Technology Transfer
Agreement and the Scale-up Agreement, this Agreement constitutes the entire
agreement of the Parties with regard to its subject matter, and supersedes all
previous written or oral representations, agreements and understandings between
ImmunoGen and Sicor, provided that this Agreement shall supersede Sections 6.1
and 6.2 of the Technology Transfer Agreement in their entirety.  This Agreement,
may only be changed by a writing signed by authorized representatives of the
Party(ies) to be bound.

 

16.6.            Conflicts.  If there is any conflict, discrepancy, or
inconsistency between the terms of this Agreement and the Technology Transfer
Agreement, the Scale-up Agreement, or the Quality Agreement, the terms of this
Agreement will control.

 

16.7.            Headings; Construction.  The Section headings are intended for
convenience of reference only and are not intended to be a part of or to affect
the meaning or interpretation of this Agreement. Both Parties have participated
equally in the formation of this Agreement and the language of this Agreement
will not be presumptively construed against either Party.

 

16.8.            No Partnership or Employment Relationship.  This Agreement does
not create a partnership or employment relationship between ImmunoGen and the
Sicor.

 

16.9.            Waiver.  The waiver by either Party hereto of any right
hereunder or the failure to perform or of a breach by the other Party will not
be deemed a waiver of any other right hereunder or of any other breach or
failure by said other Party whether of a similar nature or otherwise.

 

16.10.      Counterparts.  This Agreement may be executed in two (2) or more
counterparts, each of which will be deemed an original, but all of which
together will constitute one and the same instrument.

 

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

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

 

28

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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
by their duly authorized representatives as of the date first above written.

 

 

ImmunoGen, Inc.

 

 

 

 

 

 

By:

/s/ Craig Barrows

 

 

Name:

Craig Barrows

 

 

Title:

Vice President

 

 

Date:

9 DEC 2010

 

 

 

 

 

 

Sicor S.r.l.

 

 

 

 

 

 

By:

/s/ David Mezraghi

 

 

Name:

David Mezraghi

 

 

Title:

Managing Director

 

 

Date:

Dec. 21, 2010

 

 

 

 

 

 

Sicor S.r.l..

 

 

 

 

 

 

By:

/s/ Stefano Lombardi

 

 

Name:

Stefano Lombardi

 

 

Title:

General Manager

 

 

Date:

14th Dec. 2010

 

 

 

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

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

 

29

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