10.1


 


Execution Copy


 


COLLABORATION
AND LICENSE AGREEMENT


 


By
and Between


 


IMMUNOGEN,
INC.


 


and


 


AVENTIS
PHARMACEUTICALS INC.


 


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


 

















 


TABLE OF CONTENTS


 


	
  ARTICLE 1

  	
   

  	
  DEFINITIONS

  
	
   

  	
   

  	
   

  
	
  ARTICLE 2

  	
   

  	
  RESEARCH PROGRAM

  
	
   

  	
   

  	
   

  
	
  2.1

  	
   

  	
  General

  
	
   

  	
   

  	
   

  
	
  2.2

  	
   

  	
  Burdened Technology

  
	
   

  	
   

  	
   

  
	
  2.3

  	
   

  	
  Joint Research Committee

  
	
   

  	
   

  	
   

  
	
  2.4

  	
   

  	
  Joint Research Project
  Teams

  
	
   

  	
   

  	
   

  
	
  2.5

  	
   

  	
  Conduct of the Research
  Program

  
	
   

  	
   

  	
   

  
	
  2.6

  	
   

  	
  Annual Research Plan

  
	
   

  	
   

  	
   

  
	
  2.7

  	
   

  	
  Materials

  
	
   

  	
   

  	
   

  
	
  2.8

  	
   

  	
  Targets

  
	
   

  	
   

  	
   

  
	
  2.9

  	
   

  	
  Research Program Records

  
	
   

  	
   

  	
   

  
	
  2.10

  	
   

  	
  Disclosure of
  Research Program Results

  
	
   

  	
   

  	
   

  
	
  2.11

  	
   

  	
  Material Transfer

  
	
   

  	
   

  	
   

  
	
  2.12

  	
   

  	
  Liability

  
	
   

  	
   

  	
   

  
	
  2.13

  	
   

  	
  Use of Approved
  Subcontractors

  
	
   

  	
   

  	
   

  
	
  ARTICLE 3

  	
   

  	
  PRECLINICAL
  AND CLINICAL DEVELOPMENT PROGRAM

  
	
   

  	
   

  	
   

  
	
  3.1

  	
   

  	
  Selection of Lead
  Antibodies

  
	
   

  	
   

  	
   

  
	
  3.2

  	
   

  	
  Designation of an EDC
  Antibody

  
	
   

  	
   

  	
   

  
	
  3.3

  	
   

  	
  Development
  of an EDC Antibody into a Collaboration Product

  
	
   

  	
   

  	
   

  
	
  3.4

  	
   

  	
  Inclusion of Rights

  
	
   

  	
   

  	
   

  
	
  3.5

  	
   

  	
  Joint Development Committee

  
	
   

  	
   

  	
   

  
	
  3.6

  	
   

  	
  Development Activities

  
	
   

  	
   

  	
   

  
	
  3.7

  	
   

  	
  Dropped Products

  
	
   

  	
   

  	
   

  
	
  3.8

  	
   

  	
  Right of
  *****; Royalty to Aventis

  
	
   

  	
   

  	
   

  
	
  3.9

  	
   

  	
  Use Of Approved
  Subcontractors

  
	
   

  	
   

  	
   

  
	
  ARTICLE 4

  	
   

  	
  MANUFACTURE AND SUPPLY

  
	
   

  	
   

  	
   

  
	
  4.1

  	
   

  	
  Supply
  of Preclinical Materials, Clinical Materials and Product

  
	
   

  	
   

  	
   

  
	
  4.2

  	
   

  	
  Manufacturing and
  Supply Agreement

  
	
   

  	
   

  	
   

  
	
  4.3

  	
   

  	
  Purchase of Dedicated
  Equipment

  
	
   

  	
   

  	
   

  
	
  4.4

  	
   

  	
  Use of Approved
  Subcontractors

  



 


i

















 


	
  ARTICLE 5

  	
   

  	
  REGULATORY MATTERS

  
	
   

  	
   

  	
   

  
	
  5.1

  	
   

  	
  Ownership

  
	
   

  	
   

  	
   

  
	
  5.2

  	
   

  	
  Regulatory Coordination

  
	
   

  	
   

  	
   

  
	
  5.3

  	
   

  	
  Review of
  Correspondence for Products

  
	
   

  	
   

  	
   

  
	
  5.4

  	
   

  	
  Notice of Adverse Events

  
	
   

  	
   

  	
   

  
	
  ARTICLE 6

  	
   

  	
  COMMERCIALIZATION PROGRAM

  
	
   

  	
   

  	
   

  
	
  6.1

  	
   

  	
  Objectives
  for Commercialization of Products

  
	
   

  	
   

  	
   

  
	
  6.2

  	
   

  	
  ImmunoGen
  Option to Co-Promote Products

  
	
   

  	
   

  	
   

  
	
  6.3

  	
   

  	
  Decision Making; Meetings

  
	
   

  	
   

  	
   

  
	
  6.4

  	
   

  	
  Duties

  
	
   

  	
   

  	
   

  
	
  6.5

  	
   

  	
  Notice of
  Number of ImmunoGen Sales Reps

  
	
   

  	
   

  	
   

  
	
  6.6

  	
   

  	
  Reimbursement

  
	
   

  	
   

  	
   

  
	
  6.7

  	
   

  	
  Sales Rep Performance

  
	
   

  	
   

  	
   

  
	
  6.8

  	
   

  	
  Booking Sales

  
	
   

  	
   

  	
   

  
	
  6.9

  	
   

  	
  Promotional Materials

  
	
   

  	
   

  	
   

  
	
  6.10

  	
   

  	
  Information Exchange

  
	
   

  	
   

  	
   

  
	
  6.11

  	
   

  	
  Public Statements
  Regarding Products

  
	
   

  	
   

  	
   

  
	
  6.12

  	
   

  	
  Compliance with Laws

  
	
   

  	
   

  	
   

  
	
  6.13

  	
   

  	
  Use of Subcontractors

  
	
   

  	
   

  	
   

  
	
  6.14

  	
   

  	
  Training Program

  
	
   

  	
   

  	
   

  
	
  6.15

  	
   

  	
  Labeling

  
	
   

  	
   

  	
   

  
	
  ARTICLE 7

  	
   

  	
  LICENSES AND EXCLUSIVITY

  
	
   

  	
   

  	
   

  
	
  7.1

  	
   

  	
  ImmunoGen Grants

  
	
   

  	
   

  	
   

  
	
  7.2

  	
   

  	
  Aventis Grants

  
	
   

  	
   

  	
   

  
	
  7.3

  	
   

  	
  Technology Transfer

  
	
   

  	
   

  	
   

  
	
  7.4

  	
   

  	
  Retained Rights

  
	
   

  	
   

  	
   

  
	
  7.5

  	
   

  	
  Exclusivity

  
	
   

  	
   

  	
   

  
	
  7.6

  	
   

  	
  Section 365(n) of the
  Bankruptcy Code

  



 


ii

















 


	
  ARTICLE 8

  	
   

  	
  FINANCIAL PROVISIONS

  
	
   

  	
   

  	
   

  
	
  8.1

  	
   

  	
  Upfront Research Payment

  
	
   

  	
   

  	
   

  
	
  8.2

  	
   

  	
  Payments

  
	
   

  	
   

  	
   

  
	
  8.3

  	
   

  	
  Determination That Payments
  Are Due

  
	
   

  	
   

  	
   

  
	
  8.4

  	
   

  	
  Royalties

  
	
   

  	
   

  	
   

  
	
  ARTICLE 9

  	
   

  	
  ROYALTY PAYMENTS; REPORTING; BOOKS AND
  RECORDS

  
	
   

  	
   

  	
   

  
	
  9.1

  	
   

  	
  Reports and Payments

  
	
   

  	
   

  	
   

  
	
  ARTICLE 10

  	
   

  	
  INTELLECTUAL PROPERTY OWNERSHIP,
  PROTECTION AND RELATED MATTERS

  
	
   

  	
   

  	
   

  
	
  10.1

  	
   

  	
  Aventis Intellectual Property
  Rights

  
	
   

  	
   

  	
   

  
	
  10.2

  	
   

  	
  ImmunoGen
  Intellectual Property Rights

  
	
   

  	
   

  	
   

  
	
  10.3

  	
   

  	
  Program Intellectual Property
  Rights

  
	
   

  	
   

  	
   

  
	
  10.4

  	
   

  	
  Prosecution and Maintenance of Patent
  Rights

  
	
   

  	
   

  	
   

  
	
  10.5

  	
   

  	
  Cooperation

  
	
   

  	
   

  	
   

  
	
  10.6

  	
   

  	
  Third Party Infringement

  
	
   

  	
   

  	
   

  
	
  10.7

  	
   

  	
  Other Intellectual Property
  Infringement

  
	
   

  	
   

  	
   

  
	
  10.8

  	
   

  	
  Marks
  for Products

  
	
   

  	
   

  	
   

  
	
  ARTICLE 11

  	
   

  	
  CONFIDENTIALITY; NON-SOLICITATION

  
	
   

  	
   

  	
   

  
	
  11.1

  	
   

  	
  Confidential Information

  
	
   

  	
   

  	
   

  
	
  11.2

  	
   

  	
  Exception for Disclosure of Tax Treatment

  
	
   

  	
   

  	
   

  
	
  11.3

  	
   

  	
  Employee and Advisor Obligations

  
	
   

  	
   

  	
   

  
	
  11.4

  	
   

  	
  Term

  
	
   

  	
   

  	
   

  
	
  11.5

  	
   

  	
  Publications

  
	
   

  	
   

  	
   

  
	
  11.6

  	
   

  	
  Prohibition on Solicitation

  
	
   

  	
   

  	
   

  
	
  ARTICLE 12

  	
   

  	
  TERM AND TERMINATION

  
	
   

  	
   

  	
   

  
	
  12.1

  	
   

  	
  Term

  
	
   

  	
   

  	
   

  
	
  12.2

  	
   

  	
  Material Breach; Termination

  
	
   

  	
   

  	
   

  
	
  12.3

  	
   

  	
  Certain Rights Upon Scheduled Expiration
  of the Research Program Term

  
	
   

  	
   

  	
   

  
	
  12.4

  	
   

  	
  Residual Rights; Survival

  



 


iii

















 


	
  ARTICLE 13

  	
   

  	
  JOINT STEERING COMMITTEE

  
	
   

  	
   

  	
   

  
	
  13.1

  	
   

  	
  Joint Steering Committee

  
	
   

  	
   

  	
   

  
	
  13.2

  	
   

  	
  Chairperson of the Joint Steering
  Committee

  
	
   

  	
   

  	
   

  
	
  ARTICLE 14

  	
   

  	
  REPRESENTATIONS, WARRANTIES AND
  COVENANTS

  
	
   

  	
   

  	
   

  
	
  14.1

  	
   

  	
  Representation of
  Authority; Consents

  
	
   

  	
   

  	
   

  
	
  14.2

  	
   

  	
  No Conflict

  
	
   

  	
   

  	
   

  
	
  14.3

  	
   

  	
  Knowledge of Pending or Threatened
  Litigation

  
	
   

  	
   

  	
   

  
	
  14.4

  	
   

  	
  Disclosure of Certain Agreements

  
	
   

  	
   

  	
   

  
	
  14.5

  	
   

  	
  Disclaimer of Warranty

  
	
   

  	
   

  	
   

  
	
  14.6

  	
   

  	
  Additional ImmunoGen
  Representations, Warranties and Covenants

  
	
   

  	
   

  	
   

  
	
  ARTICLE 15

  	
   

  	
  MISCELLANEOUS PROVISIONS

  
	
   

  	
   

  	
   

  
	
  15.1

  	
   

  	
  Indemnification

  
	
   

  	
   

  	
   

  
	
  15.2

  	
   

  	
  Insurance

  
	
   

  	
   

  	
   

  
	
  15.3

  	
   

  	
  Governing Law

  
	
   

  	
   

  	
   

  
	
  15.4

  	
   

  	
  Assignment

  
	
   

  	
   

  	
   

  
	
  15.5

  	
   

  	
  Amendments

  
	
   

  	
   

  	
   

  
	
  15.6

  	
   

  	
  Change of Control of ImmunoGen

  
	
   

  	
   

  	
   

  
	
  15.7

  	
   

  	
  Notices

  
	
   

  	
   

  	
   

  
	
  15.8

  	
   

  	
  Force Majeure

  
	
   

  	
   

  	
   

  
	
  15.9

  	
   

  	
  Compliance with Export Regulations

  
	
   

  	
   

  	
   

  
	
  15.10

  	
   

  	
  Public Announcements

  
	
   

  	
   

  	
   

  
	
  15.11

  	
   

  	
  Independent Contractors

  
	
   

  	
   

  	
   

  
	
  15.12

  	
   

  	
  No
  Strict Construction

  
	
   

  	
   

  	
   

  
	
  15.13

  	
   

  	
  Headings

  
	
   

  	
   

  	
   

  
	
  15.14

  	
   

  	
  No Implied Waivers; Rights
  Cumulative

  
	
   

  	
   

  	
   

  
	
  15.15

  	
   

  	
  Severability

  
	
   

  	
   

  	
   

  
	
  15.16

  	
   

  	
  Execution in Counterparts

  
	
   

  	
   

  	
   

  
	
  15.17

  	
   

  	
  No
  Third Party Beneficiaries

  
	
   

  	
   

  	
   

  
	
  15.18

  	
   

  	
  No Consequential Damages

  



 


iv

















 


COLLABORATION
AND LICENSE AGREEMENT


 


This Collaboration and License Agreement dated as of July 30, 2003
(the “Effective Date”) is by and between ImmunoGen, Inc., a
Massachusetts corporation with a principal office at 128 Sidney Street,
Cambridge, Massachusetts 02139 (“ImmunoGen”), and Aventis
Pharmaceuticals Inc., a Delaware corporation with a principal office at 200
Crossing Boulevard, Bridgewater, New Jersey 08807 (“Aventis”).


 


INTRODUCTION


 


WHEREAS, Aventis is in the business of discovering, developing and
commercializing pharmaceutical products;


 


WHEREAS, ImmunoGen is in the business of discovering and developing
antibody-based therapeutics;


 


WHEREAS, Aventis desires to access ImmunoGen’s scientific and
development expertise in the areas of antibody target validation, antibody
generation and humanization, effector molecule generation and development,
conjugation and linker technology, and process development expertise for
antibody-drug conjugates; and


 


WHEREAS, ImmunoGen and Aventis are interested in collaborating in the
identification and validation of targets for use in the discovery of antibodies
and antibody-drug conjugates in the Collaborative Focus Area and in the
development and commercialization of such antibodies and antibody-drug
conjugates.


 


NOW, THEREFORE, ImmunoGen and Aventis agree as follows:


 


ARTICLE 1


 


DEFINITIONS


 


When used in this Agreement, each of the following terms shall have the
meanings set forth in this Article 1:


 


1.1          “Active” or “Activity”,
with respect to an Antibody or TAP Antibody, means that such Antibody or TAP
Antibody has the ***** to an Antibody Target as determined by the Joint
Research Committee on an Antibody Target-by-Antibody Target basis.


 


1.2          “Adverse Event”
means any untoward medical occurrence in a human patient or subject who is
administered a product, whether or not considered related to the product,
including, without limitation, any undesirable sign (including abnormal
laboratory findings of clinical concern), symptom or disease associated with
the use of such product.


 

















 


1.3          “Affiliate” means
any corporation, company, partnership, joint venture, firm and/or other entity
that controls, is controlled by, or is under common control with a Party to
this Agreement.  For purposes of this
Section 1.3, “control” shall be presumed to exist if one of the following
conditions is met: (a) in the case of corporate entities, direct or indirect
ownership of more than fifty percent (50%) of the stock or shares having the
right to vote for the election of directors, and (b) in the case of
non-corporate entities, direct or indirect ownership of more than fifty percent
(50%) of the equity interest with the power to direct the management and
policies of such non-corporate entities or status as the general partner in the
case of any partnership.  The Parties
acknowledge that in the case of certain entities organized under the laws of
certain countries outside of the United States, the maximum percentage
ownership permitted by law for a foreign investor may be fifty percent (50%) or
less, and that in such case such lower percentage shall be substituted in the
preceding sentence, provided that such owner has the power to direct the
management and policies of such entity.


 


1.4          “Annual Research Plan”
means the plan and budget to be developed by the Joint Research Committee for
***** each Contract Year, to be updated as necessary during each Contract Year,
setting forth, among other things, a master plan for the Research Program
during the Research Program Term and the matters described in Section 2.6
below.  Exhibit A sets forth the
Annual Research Plan for the Contract Year 1.


 


1.5          “Antibody” means a
polyclonal or monoclonal antibody, whether multiple or single chain,
recombinant or naturally occurring, whole or fragment, and any variants,
derivatives or constructs thereof, including but not limited to, antigen
binding portions including Fab, Fab’, F(ab’)2, Fv, dAb and CDR fragments,
single chain antibodies (scFv), chimeric antibodies, diabodies and polypeptides
(including any humanized versions thereof) that contain at least a portion of
an immunoglobulin that is sufficient to confer specific antigen binding to the
polypeptide.  When used alone, the term
“Antibody” does not include TAP Antibodies.


 


1.6          “Antibody Progression
Manual” means the manual prepared by Aventis and ImmunoGen that sets forth
selection criteria to be used by the Joint Research Committee in its
Development decisions with respect to any Antibody or TAP Antibody, as amended
from time to time by the Joint Research Committee.


 


1.7          “Antibody Target”
means, subject to the limitations set forth in Section 2.8.2(b), *****
that (a) either Party ***** has ***** in ***** or ***** or ***** that may be
useful in the ***** and (b) has been ***** by such ***** to the ***** for *****
in the *****.


 


1.8          “Approved
Subcontractors” means (a) any Third Party with which ImmunoGen has entered
into a subcontract agreement for the supply or manufacture of components or
materials as of the Effective Date, but only with respect to such subcontract
agreement, and (b) any Third Party approved by the Joint Research Committee or
the Joint Development Committee, as appropriate, as a subcontractor for the
performance of a Party’s obligations hereunder, but only with respect to the
performance of the obligations for which such approval was granted.  Schedule 1.8 to this Agreement
sets forth all Approved Subcontractors of ImmunoGen as of the Effective Date.


 


2

















 


1.9          “Aventis Intellectual
Property” means the Aventis Technology, Aventis Patent Rights, any other
intellectual property rights Controlled by Aventis covering the Aventis
Materials, Aventis Technology Improvements, and all Patent Rights Controlled by
Aventis Covering any Aventis Technology Improvements.


 


1.10        “Aventis Materials”
means any material, including without limitation, biological materials or
chemical compounds such as tissue samples, molecules, reagents and screens,
Antibody Targets, Antibodies, Effector Molecules and Linkers, which are (a)
Controlled by Aventis and (b) provided by Aventis, and accepted by the Joint
Research Committee, for use in the Research Program in accordance with
Section 2.2.2 of this Agreement.


 


1.11        “Aventis Patent Rights”
means all Patent Rights that are Controlled by Aventis that Cover any Aventis
Technology or Aventis Materials.


 


1.12        “Aventis Technology”
means any Technology that is used by Aventis, or provided by Aventis for use,
in the Research Program and that is (a) Controlled by Aventis as of the
Effective Date or (b) developed or conceived by employees of, or consultants
to, Aventis on or after the Effective Date in the conduct of activities outside
of the Research Program.  For purposes
of clarity, Aventis Technology shall not include Aventis Technology Improvements
or Aventis Materials.


 


1.13        “Aventis Technology
Improvements” means any Technology which (a) is developed or conceived by
employees of, or consultants to, either Party or jointly by both Parties under
this Agreement and (b) is Covered by the Aventis Patent Rights.


 


1.14        “BLA” means (a) (i) a
Biologics License Application (as defined in Title 21 of the United States Code
of Federal Regulations, as amended from time to time) filed with the FDA, or
any successor application or procedure, and (ii) any foreign counterpart of a
U.S. Biologics License Application, and (b) all supplements and amendments,
including supplemental Biologics License Applications (and any foreign
counterparts), that may be filed with respect to the foregoing.


 


1.15        “Business Day” means a
day on which banking institutions in New York are open for business.


 


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


 


1.17        “Calendar Year” means
each successive period of twelve (12) months commencing on January 1 and
ending on December 31.


 


3

















 


1.18        “Change of Control”
means (a) a merger or consolidation of ImmunoGen and any Third Party which
results in the voting securities of ImmunoGen outstanding immediately prior
thereto ceasing to represent more than fifty percent (50%) of the combined
voting power of the surviving entity immediately after such merger or
consolidation, or (b) any Third Party, together with its affiliates, becoming
the beneficial owner of fifty percent (50%) or more of the combined voting
power of the outstanding securities of ImmunoGen, or (c) the sale or other
transfer to a Third Party of all or substantially all of ImmunoGen’s assets
which relate to this Agreement.


 


1.19        “Clinical Materials”
means any materials, including without limitation, any Effector Molecules,
Linkers or Program Antibodies, used in connection with the Development or
Commercialization of a Product.


 


1.20        “Collaboration Product”
means any product, other than a Licensed Product, containing an EDC Antibody.


 


1.21        “Collaborative Focus Area”
means the use of Antibodies and TAP Antibodies in the prevention, control and/or
treatment in humans of precancerous and/or cancerous conditions.


 


1.22        “Combination Product”
means any Product or ***** that contains, in addition to an Antibody or TAP
Antibody, one or more other ingredients that (a) are not covered by ImmunoGen
Intellectual Property or Program Intellectual Property, and (b) have
independent biologic or chemical activity as a therapeutic, prophylactic or
diagnostic agent when present alone.


 


1.23        “Commercialization” or
“Commercialize”
means any and all activities directed to pre-launch and launch of products,
marketing, promoting, distributing, offering for sale and selling a product,
importing a product for sale, conducting Phase III Studies (other than in
connection with Development activities) and Phase IV Studies, and manufacturing
for commercial sale (except for scale-up activities, which shall be Development
activities).  When used as a verb,
“Commercialize” means to engage in Commercialization.


 


1.24        “Commercially Reasonable
Efforts” means (a) with respect to Aventis, the efforts and resources
typically used by pharmaceutical companies similar in size to Aventis,
including Aventis, to perform the obligation at issue, and (b) with respect to
ImmunoGen, the efforts and resources typically used by biotechnology companies
similar in size to ImmunoGen, including ImmunoGen, to perform the obligation at
issue; in each case with respect to a product or potential product of similar
nature at a similar stage in its development or product life and of similar
market potential, in view of conditions prevailing at the time, and evaluated
taking into account all relevant factors, including without limitation, the
mechanism of action, efficacy, safety, the anticipated regulatory authority
approved labeling, the competitiveness of alternative products that are in the
marketplace or under development, the patent and other proprietary position of
the product, the likelihood of Regulatory Approval, the profitability of the
product and other technical, scientific, legal, medical, marketing and
competitive factors.


 


4

















 


1.25        “Confidential Information”
means all proprietary materials, know-how or other information (whether or not
patentable) regarding a Party’s technology, products, business information or
objectives, which is designated as confidential in writing by the disclosing
Party, whether by letter or by the use of an appropriate stamp or legend, prior
to or at the time any such material, know-how or other information is disclosed
by the disclosing Party to the other Party. 
Notwithstanding the foregoing to the contrary, materials, know-how or
other information which is orally, electronically or visually disclosed by a
Party, or is disclosed in writing without an appropriate letter, stamp or
legend, shall constitute Confidential Information of a Party (a) if the
disclosing Party, within thirty (30) days after such disclosure, delivers to
the other Party a written document or documents describing the materials,
know-how or other information and referencing the place and date of such oral,
visual, electronic or written disclosure and the names of the persons to whom
such disclosure was made, or (b) such information is of the type that is
customarily considered to be confidential information by persons engaged in
activities that are substantially similar to the activities being engaged in by
the Parties.  Notwithstanding the
foregoing, (w) any technical or financial information of a Party disclosed at a
meeting of the Joint Research Committee, the Joint Development Committee, any
U.S. Commercialization Team or the Joint Steering Committee (or any
subcommittees or project teams of the foregoing) or disclosed through an audit
report shall constitute Confidential Information of such Party, (x) the terms
of this Agreement to the extent not disclosed in a public filing, shall
constitute Confidential Information of each Party unless otherwise specified,
(y) all know-how and trade secrets disclosed by ImmunoGen to Aventis in
connection with the license set forth in Section 7.3 of this Agreement
shall constitute Confidential Information of ImmunoGen, and (z) all know-how
and trade secrets disclosed by Aventis to ImmunoGen in connection with the
license set forth in Section 7.2.4 of this Agreement shall constitute
Confidential Information of Aventis.


 


1.26        “Contract Year” means
the period beginning on September 1, 2003 and ending on August 31,
2004 (“Contract Year 1”) and each succeeding twelve (12) month period
thereafter during the Research Program Term (referred to as “Contract
Year 2”, “Contract Year 3”, etc.) unless the Research
Program Term is terminated or extended, in which case the final Contract Year
shall end as of the last date of the Research Program Term, as terminated or
extended.


 


1.27        “Control” or “Controlled”
means with respect to any (a) material, document, item of information, method,
data or other know-how or (b) intellectual property right, the possession
(whether by ownership or license, other than by a license granted pursuant to
this Agreement) by a Party or its Affiliates of the ability to grant to the
other Party access and/or a license or sublicense as provided herein under such
item or right without violating the terms of any agreement or other arrangement
with any Third Party existing before or after the Effective Date.


 


1.28        “Cost” means, with
respect to any Product, Preclinical Materials or Clinical Materials
manufactured by Immunogen, ***** (including the ***** associated with ***** and
*****) of ***** and ***** such Product, Preclinical or Clinical Materials,
including the sum of


 


5

















 


the following components: (i)
*****, including (1) ***** used in ***** and ***** such ***** and (2) with
respect to any *****, ***** or ***** by ***** from a ***** and ***** to Aventis
without *****, the ***** by ***** to such ***** for the same; (ii) ***** to the
***** of ***** under the foregoing clause (i) (1), including ***** and *****
and ***** and *****, ***** and ***** of the ***** and ***** and ***** which are
***** to ***** based on ***** or *****, or another ***** and are subject to the
***** as determined ***** to *****; (iii) any other ***** borne by ***** for
the *****, *****, *****, *****, ***** and/or ***** of such *****, ***** or *****;
and (iv) ***** and *****, including *****, *****, *****, ***** and *****, which
are ***** to ***** based on ***** or ***** or another *****. ***** under the
foregoing clause (ii) and ***** and ***** under the foregoing clause (iv) are
allocable to each *****, ***** and/or ***** produced based upon ***** at *****
and are ***** to the ***** as ***** to *****. 
Notwithstanding the foregoing, ***** shall not ***** the ***** of *****
any ***** by ***** pursuant to ***** of this Agreement.


 


1.29        “Covering”, “Cover”,
or “Covered”
means, with respect to a Patent Right, that, but for a license granted to a
party under a Valid Claim included in such Patent Right, the practice by such
party of an invention claimed in such Patent Right would infringe such Valid
Claim.


 


1.30        “Dedicated Equipment”
means any equipment, instrument or machinery used by ImmunoGen exclusively in
the manufacturing of Product, Preclinical Materials or Clinical Materials.


 


1.31        “Detail” means a
face-to-face sales call made to an individual medical professional with
prescribing authority or a small group of such professionals during which a
Co-Promoted Product is discussed with such professional(s).


 


1.32        “Development” or “Develop”
means, with respect to an EDC Antibody, all preclinical and clinical drug
development activities undertaken to obtain Regulatory Approval of such EDC
Antibody in accordance with this Agreement after the Effective Date and up to
the obtaining of Regulatory Approval of such EDC Antibody.  These activities shall include among other
things: test method development and stability testing, toxicology, formulation,
process development, manufacturing scale-up, development-stage manufacturing,
quality assurance/quality control development and performance with respect to
clinical materials, statistical analysis and report writing, clinical studies
and regulatory affairs, product approval and registration (including pricing
approvals).  When used as a verb,
“Develop” means to engage in Development. 
Development shall include a Phase III Study conducted in conjunction
with Development activities.


 


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


 


6

















 


1.34        “Early Development
Candidate Status” or “EDC Status” means the status that may be
assigned by the Joint Research Committee to a Lead Antibody when the results of
Pre-EDC Research Evaluation Activities ***** of *****.


 


1.35        “EDC Antibody” means a
Lead Antibody that has achieved EDC Status in the Research Program, as
determined in accordance with Section 3.2.


 


1.36        “Effective Date” means
the date set forth in the first paragraph of this Agreement.


 


1.37        “Effector Molecule”
means any small molecule cytotoxic or anticancer chemical entity that may be
conjugated to an Antibody to create a TAP (Tumor Activated Prodrug).


 


1.38        “European Union” means
*****, *****, *****, *****, *****, *****, *****, *****, *****, the *****,
*****, *****, *****, ***** and the *****.


 


1.39        “Facility” means any
one or more of ImmunoGen’s plant facilities as may be designated by ImmunoGen
from time to time during the term of this Agreement.


 


1.40        “FDA” means the United
States Food and Drug Administration, or a successor agency thereto.


 


1.41        “Field” means all
human therapeutic, prophylactic and diagnostic uses.


 


1.42        “First Commercial Sale”
means, for a product, on a country-by-country basis, the first shipment of such
product to a Third Party by the selling Party, or its Affiliates or
sublicensees, in a country in the Territory after Regulatory Approval has been
achieved for such product in such country. 
Sales for test marketing, sampling and promotional uses, clinical trial
purposes or compassionate or similar use shall not be considered to constitute
a First Commercial Sale.


 


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


 


1.44        “FTE” means a full
time equivalent person year (consisting of a total of ***** hours per year) of
scientific, technical or managerial work on or directly related to the Research
Program or the Development or Commercialization of Products.


 


1.45        “Good Clinical Practices”
or “GCP”
means the standards, practices and procedures set forth in the guidelines
entitled “Guidance for Industry E6 Good Clinical Practice: Consolidated
Guidance,” including related regulatory requirements imposed by the FDA, any successor
agency and, as applicable, the equivalent thereof in jurisdictions outside the
United States.


 


7

















 


1.46        “Good Laboratory
Practices” or “GLP” means the then-current good
laboratory practice standards promulgated or endorsed by the FDA as defined in
21 C.F.R. Part 58, and comparable regulatory standards in jurisdictions outside
the United States.


 


1.47        “Good Manufacturing
Practices” or “GMP” means the then-current good
manufacturing practices required by the FDA and set forth in the U.S. Federal
Food, Drug, and Cosmetic Act, as amended, and the regulations promulgated
thereunder, for the manufacturing and testing of pharmaceutical materials, and
any other laws or regulations applicable to the manufacturing and testing of
pharmaceutical materials in jurisdictions outside the United States.


 


1.48        “ImmunoGen Intellectual
Property” means the ImmunoGen Technology, ImmunoGen Patent Rights, any
other intellectual property rights Controlled by ImmunoGen covering the
ImmunoGen Materials, ImmunoGen Technology Improvements, and all Patent Rights
Controlled by ImmunoGen Covering ImmunoGen Technology Improvements.  For purposes of clarity, the term “ImmunoGen
Intellectual Property” shall not include Program Intellectual Property.


 


1.49        “ImmunoGen Materials”
means any materials, including without limitation, biological materials or
chemical compounds such as tissue samples, molecules, reagents and screens,
Antibody Targets, Antibodies, TAP Antibodies, Effector Molecules and Linkers,
which are (a) Controlled by ImmunoGen and (b) provided by ImmunoGen, and
accepted by the Joint Research Committee, for use in the Research Program in
accordance with Section 2.2.2 of this Agreement.


 


1.50        “ImmunoGen Patent Rights”
means the patents and patent applications listed on Schedule 1.50,
and any other Patent Rights that are Controlled by ImmunoGen that Cover any
ImmunoGen Technology or ImmunoGen Materials.


 


1.51        “ImmunoGen Researcher”
means a professional researcher and scientist who is an employee of ImmunoGen
and has at least a ***** in ***** (except, as of the Effective Date, ***** who
does not have a ***** in ***** but has been employed by ImmunoGen in a capacity
which involves performing the task assigned to such individual for at least
***** (*****) *****) and other academic or professional credentials reasonably
demonstrating appropriate expertise for the task to be performed.


 


1.52        “ImmunoGen Technology”
means any Technology that is used by ImmunoGen, or provided by ImmunoGen for use,
in the Research Program and that is (a) Controlled by ImmunoGen as of the
Effective Date or (b) developed or conceived by employees of, or consultants
to, ImmunoGen on or after the Effective Date in the conduct of activities
outside of the Research Program.  For
purposes of clarity, ImmunoGen Technology shall not include ImmunoGen
Technology Improvements or ImmunoGen Materials.


 


1.53        “ImmunoGen Technology
Improvements” means any Technology which (a) is developed or conceived by
employees of, or consultants to, either Party or jointly by both Parties, under
this Agreement and (b) (i) is Covered by the ImmunoGen Patent Rights or (ii) is
a


 


8

















 


maytansinoid that is
substantially equivalent to a maytansinoid Covered by an ImmunoGen Patent Right
listed on Schedule 1.50 or (iii) is a method of manufacture or use with
respect to a maytansinoid that is substantially equivalent to a method of
manufacture or use, respectively, with respect to a maytansinoid and Covered by
an ImmunoGen Patent Right listed on Schedule 1.50.


 


1.54        “IND” means (a) (i) an
Investigational New Drug Application, as defined in the U.S. Federal Food, Drug
and Cosmetic Act, as amended, and the regulations promulgated thereunder, that
is required to be filed with the FDA before beginning clinical testing of a
pharmaceutical product in human subjects, or any successor application or
procedure and (ii) any foreign counterpart of a U.S. Investigational New Drug
Application, and (b) all supplements and amendments that may be filed with
respect to the foregoing.


 


1.55        “Joint Steering Committee”
or “JSC”
means a committee comprised of representatives of ImmunoGen and Aventis and
established for the purpose of planning and overseeing the activities under this
Agreement as contemplated by Article 13.


 


1.56        “Laws” means all laws,
statutes, rules, regulations, ordinances and other pronouncements having the
effect of law of any federal, national, multinational, state, provincial,
county, city or other political subdivision, domestic or foreign.


 


1.57        “Lead Antibody” means
a Program Antibody that meets the Lead Selection Criteria as determined by the
Joint Research Committee.


 


1.58        “Lead Selection Criteria”
means the criteria set forth in the Antibody Progression Manual that, when met
by a Program Antibody, will make such Program Antibody eligible for designation
as a Lead Antibody by the Joint Research Committee pursuant to Section 3.1
of this Agreement.


 


1.59        “Licensed Antibody”
means ***** known as *****, as more fully described on Schedule 1.59.


 


1.60        “Licensed Product”
means the first to occur of each of the following:


 


(a)           a product
containing only ***** without any Effector Molecule; or


 


(b)           a product
containing ***** to an ***** in the ***** of *****; it being understood that
any product containing ***** alone or conjugated to an Effector Molecule not in
the ***** of Effector Molecules shall be considered a *****, not a *****.


 


1.61        “Licensed TAP Antibody”
means ***** known as *****, as more fully described on Schedule 1.61.


 


1.62        “Limited Target”
means, subject to the proviso at the end of this Section 1.62:


 


9

















 


(a)           (i) any Target
where ImmunoGen has granted a Third Party the exclusive option to obtain an exclusive
license to conjugate TAP Antibodies with respect to any Effector Molecule
directed thereto (a “Limited Exclusive Option Target”) and (ii) any
Limited Exclusive Option Target where such Third Party exercises such option
and obtains such license (a “Limited Exclusive Target”),


 


(b)           (i) any Target
where ***** has ***** a ***** the ***** to ***** an ***** to ***** directed
thereto with an ***** only from the ***** of ***** (a “Limited Exclusive
Maytan Option Target”) and (ii) (A) any ***** where such ***** such *****
and ***** such ***** or (B) any ***** where ***** has a ***** and ***** to
***** directed thereto with an ***** from the ***** of ***** (each, a “Limited
Exclusive Maytan Target”),


 


(c)           (i) any Target
where ***** has ***** a ***** the ***** to ***** a ***** to ***** thereto with
an ***** from the ***** of ***** (a “Limited Non-Exclusive Maytan Option
Target”) and (ii) any ***** where such ***** such ***** and ***** such
***** (a “Limited Non-Exclusive Maytan Target”), and


 


(d)           any Target where
***** has ***** a ***** the right to ***** whether to ***** an ***** to have
such ***** become either a Limited Exclusive Maytan Option Target or Limited
Non-Exclusive Maytan Option Target and/or, ***** thereof, a Limited Exclusive
Maytan Target or Limited Non-Exclusive Maytan Target, respectively (a “Limited
Maytan Evaluation Target”);


 


provided, however, that (a) any Limited Exclusive Option Target,
Limited Exclusive Maytan Option Target or Limited Non-Exclusive Maytan Option
Target shall ***** to be a ***** if the ***** does not *****, in ***** with all
***** and *****, the ***** to ***** such ***** into a *****, ***** or *****,
respectively, and (b) any Limited Maytan Evaluation Target shall ***** to be a
***** if the ***** does not *****, in ***** with all ***** and other *****, the
***** to ***** such ***** into either (x) a Limited Exclusive Maytan Option
Target and/or a Limited Exclusive Maytan Target or (y) a Limited Non-Exclusive
Maytan Option Target and/or a Limited Non-Exclusive Maytan Target.  Schedule 1.62 sets forth a list
of the categories of Limited Targets and a description of the agreements and
the number of Targets related thereto.


 


1.63        “Linker” means any
chemical entity utilized to attach an Effector Molecule to a TAP Antibody.


 


1.64        “MAA” means an
application filed with the relevant Foreign Regulatory Authority seeking
Regulatory Approval to market and sell any Product outside the United States
for a particular indication.


 


1.65        “NDA” means a New Drug
Application, as defined in the U.S. Federal Food, Drug and Cosmetics Act or BLA
submitted to the FDA, or any successor application or procedure required for
Regulatory Approval to commence sale of a Product in the United States.


 


1.66        “Net Sales” means:


 


10

















 


(a)           with respect to
Aventis, the gross amounts invoiced by any of Aventis or its Affiliates or
sublicensees on account of sales of Products or ***** to Third Parties
(including without limitation Third Party distributors and wholesalers), less
the total of the following amounts absorbed or accrued by Aventis or its
Affiliates under generally accepted accounting principles consistently applied:


 


(i)            trade, cash and/or
quantity discounts allowed and taken directly with respect to such sales, or
reflected in the invoiced amount;


 


(ii)           excise, sales and
other consumption taxes (including VAT on the sale of Products or ***** and
excluding taxes based on income) and custom duties imposed upon and paid
directly by Aventis with respect to the Products or *****, to the extent
included in the invoice price;


 


(iii)         freight, insurance
and other transportation charges, to the extent included in the invoice price;


 


(iv)          amounts repaid or
credited by reason of returns, rejections, defects or recalls, chargebacks,
retroactive price reductions, refunds and billing errors; and


 


(v)            compulsory
payments and rebates directly related to the sale of Products or *****,
accrued, paid or deducted, pursuant to agreements (including, but not limited
to, managed care agreements) or governmental regulations.


 


Use of
Products or ***** for promotional or sampling purposes and for use in clinical
trials contemplated under this Agreement shall not be considered in determining
Net Sales.  In the case of any sale of a
Product or ***** between or among Aventis and its Affiliates or sublicensees
for resale, Net Sales shall be calculated as above only on the first arm’s
length sale thereafter to a Third Party.


 


In the
event a Product or ***** is sold as part of a Combination Product, the Net
Sales from the Combination Product, for the purposes of determining royalty
payments, shall be determined by multiplying the Net Sales of the Combination
Product (as defined in the standard Net Sales definition above), during the
applicable royalty reporting period, by the fraction, A/A+B, where A is the
average per unit sale price of active ingredient contained in the Product or
*****, when sold separately in finished form in the country in which the
Combination Product is sold and B is the average per unit sale price of active
ingredient contained in the other product(s) included in the Combination
Product when sold separately in finished form in the country in which the
Combination Product is sold, in each case during the applicable royalty reporting
period or, if sales of the Product or ***** alone did not occur in such period,
then in the most recent royalty reporting period in which arms length fair
market sales of such Product or ***** occurred.  In the event that such average sale price cannot be determined
for the Product or *****, on the one hand, and all other product(s) included in
the Combination Product, on the other, Net Sales for the purposes of
determining royalty payments shall be mutually agreed upon by the Parties based


 


11

















 


on the
relative value contributed by each component, such agreement to be negotiated
in good faith.


 


(b)           with respect to
ImmunoGen, the gross amounts invoiced by any of ImmunoGen or its Affiliates or
sublicensees on account of sales of any Dropped Products which are not
otherwise subject to a Commercialization Agreement between the Parties to Third
Parties (including without limitation Third Party distributors and
wholesalers), less the total of the following amounts absorbed or accrued by
ImmunoGen or its Affiliates under generally accepted accounting principles
consistently applied:


 


(i)            trade, cash and/or
quantity discounts allowed and taken directly with respect to such sales, or
reflected in the invoiced amount;


 


(ii)           excise, sales and
other consumption taxes (including VAT on the sale of such Dropped Products and
excluding taxes based on income) and custom duties imposed upon and paid
directly by ImmunoGen with respect to such Dropped Products, to the extent included
in the invoice price;


 


(iii)         freight, insurance
and other transportation charges, to the extent included in the invoice price;


 


(iv)          amounts repaid or
credited by reason of returns, rejections, defects or recalls, chargebacks,
retroactive price reductions, refunds and billing errors; and


 


(v)            compulsory
payments and rebates directly related to the sale of such Dropped Products,
accrued, paid or deducted, pursuant to agreements (including, but not limited
to, managed care agreements) or governmental regulations.


 


Use of
Dropped Products for promotional or sampling purposes and for use in clinical
trials contemplated under this Agreement shall not be considered in determining
Net Sales.  In the case of any sale of a
Dropped Product between or among ImmunoGen and its Affiliates or sublicensees
for resale, Net Sales shall be calculated as above only on the first arm’s
length sale thereafter to a Third Party.


 


1.67        “*****”
means a ***** (other than a Product or Dropped Product) that contains a *****
or other ***** (other than an ***** or *****) that is ***** by ***** in a *****
in ***** against a ***** (the “*****”).


 


1.68        “Party” means Aventis
or ImmunoGen; “Parties” means Aventis and ImmunoGen.


 


1.69        “Patent Rights” means
all existing patents and patent applications and all patent applications
hereafter filed, including any continuations, continuations-in-part, divisions,
provisionals or any substitute applications, any patent issued with respect to
any such patent applications, any reissue, reexamination, renewal or extension
(including any supplemental


 


12

















 


patent certificate) of any such
patent, and any confirmation patent or registration patent or patent of
addition based on any such patent, and all foreign counterparts of any of the
foregoing.


 


1.70        “Phase I Study” means
a clinical study in subjects to evaluate the pharmacokinetic and
pharmacodynamic properties, maximum tolerated dose, dosing interval, and
absorption, distribution, metabolism and excretion (ADME) of a candidate drug.


 


1.71        “Phase IIB Study”
means a controlled dose ranging clinical trial to evaluate further the efficacy
and safety of a candidate drug in the targeted patient population and to define
the optimal dosing regimen.


 


1.72        “Phase III Study”
means, as to a particular product for a particular indication, a controlled and
lawful study in humans of the safety and efficacy of such product for such
indication, which is prospectively designed to demonstrate statistically
whether such product is safe and effective for use in such indication in a
manner sufficient to file a Drug Approval Application to obtain Regulatory
Approval to market and sell that product for the indication under investigation
in such study.


 


1.73        “Phase IV Study” means
a study initiated in a country after receipt of Regulatory Approval in such
country within the approved product labeling.


 


1.74        “Preclinical Materials”
means any materials, including without limitation any Effector Molecules,
Linkers, Program Antibodies and Antibody Targets, used for the purpose of
conducting preclinical testing of a Product.


 


1.75        “Pre-EDC Research
Evaluation Activities” means any and all of the activities relating to the
qualification of a Program Antibody for EDC Status, including, but not limited
to, molecular biological or other modification activities and preclinical
activities.


 


1.76        “Products” means,
collectively, any and all Licensed Products and Collaboration Products.


 


1.77        “Program Antibody”
means an Antibody or a TAP Antibody that: (a) (i) is in a Party’s or any of its
Affiliates’ Control as of the Effective Date, or becomes Controlled by a Party
or any of its Affiliates during the Research Program Term but outside of the
Research Program, (ii) is Active against a Program Target and (iii) is selected
by the Joint Research Committee for Pre-EDC Research Evaluation Activities in
the conduct of the Research Program; or (b) is created, made or acquired by a
Party or its Affiliate in the course of performing activities under the Research
Program and is Active against a Program Target.


 


1.78        “Program Intellectual
Property” means, collectively, Program Patent Rights, Program Materials and
Program Technology.  For purposes of
clarity, “Program Intellectual Property” shall not include Aventis Technology
Improvements or ImmunoGen Technology Improvements.


 


13

















 


1.79        “Program Materials”
means any material first identified or discovered by either or both Parties in
the conduct of the Research Program, including, without limitation, biological
materials or chemical compounds such as tissue samples, molecules, reagents and
screens, Antibody Targets, Program Antibodies, Effector Molecules and Linkers
subject to Burdened Technology Obligations.


 


1.80        “Program Patent Rights”
means the Patent Rights that Cover any Program Technology or Program Materials.


 


1.81        “Program Target” means
any Antibody Target that is ***** by the ***** as a Program Target and for
which the Joint Research Committee has committed to initiate activities in the
Research Program that relate to ***** or ***** of ***** against such Target.


 


1.82        “Program Technology”
means any Technology, other than ImmunoGen Technology Improvements and Aventis
Technology Improvements, that is developed or conceived by employees of, or
consultants to, either Party or jointly by both Parties, in the conduct of the
Research Program.


 


1.83        “Regulatory Approval”
means any and all approvals (including any applicable governmental price and
reimbursement approvals), licenses, registrations, or authorizations of any
federal, national, multinational, state, provincial or local regulatory agency,
department, bureau or other governmental entity necessary for the manufacture,
use, storage, import, transport, promotion, marketing and sale of a product in
a country or group of countries.


 


1.84        “Research Program”
means the collaborative research program to be conducted by the Parties in
accordance with the Annual Research Plan and any Development activities
allocated to ImmunoGen FTEs under this Agreement.


 


1.85        “ROW” means all the
countries in the Territory excluding the United States.


 


1.86        “Serious Adverse Event”
means any Adverse Event occurring at any dose that:


 


(a)           results in death or
threatens life;


 


(b)           results in persistent
or significant disability/incapacity;


 


(c)           results in or
prolongs hospitalization;


 


(d)           results in a
congenital anomaly or birth defect; or


 


(e)           is otherwise
medically significant.


 


1.87        “TAP Antibody” means
an Antibody that is conjugated to an Effector Molecule.


 


1.88        “Target” means any
antigen that can be recognized by an Antibody.


 


14

















 


1.89        “*****”
means, with respect to a given Program Target, a ***** of ***** which the Joint
Research Committee determines in good faith based upon reasonable scientific
evidence to so designate, including, in particular, a determination that the
***** is ***** to the given ***** and is reasonably likely to have
substantially the ***** as such *****. 
The Parties hereby acknowledge and agree that unless the Joint Research
Committee has a reasonable scientific basis for determining otherwise: (a) no
more than ***** (*****) ***** may be included as part of a *****; and (b) a
***** shall not include all or substantially all of the ***** known to be *****
with a *****.


 


1.90        “Technology” means and
includes all inventions, discoveries, improvements, trade secrets and
proprietary methods and materials, whether or not patentable, relating to the
Field, including but not limited to (a) samples of, methods of production or
use of, and structural and functional information pertaining to, chemical
compounds, proteins or other biological substances and (b) data, formulations,
techniques and know-how (including any negative results).


 


1.91        “Territory” means the
entire world.


 


1.92        “Third Party” means
any person or entity other than a Party or any of its Affiliates.


 


1.93        “Valid Claim” means a
claim (a) of any issued, unexpired patent which has not been revoked or held
unenforceable or invalid by a decision of a court or governmental agency of
competent jurisdiction from which no appeal can be taken, or with respect to
which an appeal is not taken within the time allowed for appeal, and which has
not been disclaimed, denied or admitted to be invalid or unenforceable through
reissue, disclaimer or otherwise, or (b) of any patent application which shall
not have been pending on or after the ***** (*****th) anniversary of the date
of issuance of a first Patent Office communication during examination of the
first application related thereto, and shall not have been earlier cancelled,
withdrawn or abandoned, and, on a country-by-country basis, which is
enforceable on the operative date of inquiry by virtue of applicable Law in
such country.


 


1.94        Additional Definitions.  Each of the following definitions is set
forth in the Section of this Agreement indicated below:


 


	
  Definition

  	
   

  	
  Section

  
	
   

  	
   

  	
   

  
	
  Aventis Indemnified Parties

  	
   

  	
  15.1.2

  
	
  Aventis Reply

  	
   

  	
  3.8.2

  
	
  Breaching Party

  	
   

  	
  12.2.1

  
	
  Burdened Technology

  	
   

  	
  2.2.1

  
	
  Burdened Technology Obligations

  	
   

  	
  2.2.1

  
	
  Collaboration Product Royalties

  	
   

  	
  8.4.2

  
	
  Commercialization Agreement

  	
   

  	
  3.8.1

  
	
  Comparable Product

  	
   

  	
  2.9.1

  



 


15

















 


	
  Confidential Information

  	
   

  	
  2.9.1

  
	
  Co-Promoted Product

  	
   

  	
  6.2

  
	
  Dropped Product

  	
   

  	
  3.7.1

  
	
  Dropped Target

  	
   

  	
  2.8.4

  
	
  Event

  	
   

  	
  8.2

  
	
  ImmunoGen Indemnified Parties

  	
   

  	
  15.1.1

  
	
  ImmunoGen Notice

  	
   

  	
  3.8.1

  
	
  ImmunoGen Sales Reps

  	
   

  	
  6.5

  
	
  Joint Development Committee

  	
   

  	
  3.5.1

  
	
  Joint Research Committee

  	
   

  	
  2.3.1

  
	
  Joint Research Project Team

  	
   

  	
  2.3.1

  
	
  Lead Data Package

  	
   

  	
  3.1.1

  
	
  Licensed Product Royalties

  	
   

  	
  8.4.1

  
	
  Limitations

  	
   

  	
  2.8.2

  
	
  Limited Exclusive Maytan Option Target

  	
   

  	
  1.62(b)

  
	
  Limited Exclusive Maytan Target

  	
   

  	
  1.62(b)

  
	
  Limited Exclusive Option Target

  	
   

  	
  1.62(a)

  
	
  Limited Exclusive Target

  	
   

  	
  1.62(a)

  
	
  Limited Maytan Evaluation Target

  	
   

  	
  1.62(d)

  
	
  Limited Non-Exclusive Maytan Option Target

  	
   

  	
  1.62(c)

  
	
  Limited Non-Exclusive Maytan Target

  	
   

  	
  1.62(c)

  
	
  Limited Target

  	
   

  	
  2.8.2

  
	
  Limited Target Notice

  	
   

  	
  2.8.2

  
	
  Marks

  	
   

  	
  10.8.1

  
	
  naked Antibodies

  	
   

  	
  2.8.2(b)(ii)

  
	
  *****

  	
   

  	
  3.8.2

  
	
  Non-Antibody Target

  	
   

  	
  1.67

  
	
  *****

  	
   

  	
  4.1.2

  
	
  Patent Prosecution

  	
   

  	
  10.4.1

  
	
  *****

  	
   

  	
  7.5.2

  
	
  Research Program Term

  	
   

  	
  2.1.2

  
	
  Royalties

  	
   

  	
  8.4.2

  
	
  U.S. Commercialization Team

  	
   

  	
  6.2

  
	
  U.S. Marketing Plan

  	
   

  	
  6.4(b)

  
	
  Withholding Taxes

  	
   

  	
  9.1.2

  



 


ARTICLE 2

RESEARCH PROGRAM


 


2.1          General.


 


2.1.1       Objective.


 


16

















 


(a)           The Parties shall
collaborate in carrying out the Research Program as set forth in the
then-current Annual Research Plan, with the global objectives, consistent with
the resources allocated to such activities under the Annual Research Plan, of:
(i) utilizing ImmunoGen Technology, ImmunoGen Materials and ImmunoGen
Technology Improvements within the Collaborative Focus Area, including Target
validation, Antibody generation and humanization, Effector Molecule generation
and development, and process development expertise for TAP Antibodies and
Linkers; (ii) identifying Targets for designation as Antibody Targets and
evaluating Antibody Targets for designation as Program Targets suitable for
discovery and development of Antibodies and TAP Antibodies Active against such
Program Targets; (iii) ***** with respect to TAP Antibodies and Linker
conjugation; (iv) *****, prior to the end of *****, ***** (*****) ***** ready
to enter *****; (v) *****, prior to the end of *****, ***** (*****) or *****
(*****) ***** ready to enter ***** (including ***** of all ***** with respect
thereto), and between ***** (*****) to ***** (*****) *****, of which at least
***** (*****) contains a ***** arising out of the Research Program, in each
case with potential utility in the Collaboration Focus Area; and (vi) providing
Aventis with access pursuant to the terms of this Agreement to ImmunoGen’s
scientific and development expertise in the areas of antibody target
validation, antibody generation and humanization, effector molecule generation
and development, conjugation and linker technology, and process development
expertise for antibody-drug conjugates.


 


(b)           It is intended
that, to the extent practicable, both Parties will participate in the full
range of activities to be conducted in the Research Program, including without
limitation, Target identification and validation, generation of Antibodies and
TAP Antibodies, resurfacing of Antibodies and Pre-EDC Research Evaluation
Activities with respect to Program Antibodies, and chemical synthesis and
optimization of Effector Molecules and Linkers, all of the foregoing subject to
the Parties’ respective capabilities and capacities to perform such activities
and, in each case, in accordance with the Annual Research Plan.


 


(c)           It is intended that
the Research Program will be conducted as a collaborative effort with
activities by the Parties carried out at each Party’s respective facilities as
may be outlined in the Annual Research Plan.


 


(d)           It is also
understood that, during the Research Program Term, Aventis and, subject to the
provisions of Section 7.5, ImmunoGen, will each be conducting broader
Target identification and validation and research evaluation of Antibodies, TAP
Antibodies, Effector Molecules and Linkers, as well as assay configuration,
high throughput screening and evaluation of small molecule and other compounds,
in each case which may be directed to the Collaborative Focus Area but which
may be conducted outside of the Research Program.


 


(e)           It is also intended
that, during the Research Program Term, the Parties shall collaborate in making
available for the Research Program, Antibodies, TAP Antibodies, Targets,
Effector Molecules and Linkers, as set forth in the then current Annual
Research Plan, with the global objectives of maximizing the quantity and
quality of


 


17

















 


Collaboration Products
consistent with the resources allocated to such activities under the Annual
Research Plan.


 


2.1.2       Term.  The term of the Research Program (the “Research
Program Term”) shall commence on the first day of Contract Year 1 and end
on the last day of Contract Year 3, unless (a) earlier terminated pursuant to
the provisions of Article 12 or (b) extended pursuant to the provisions of
this Section 2.1.2; provided, however, that, Aventis shall
have the option to extend the Research Program Term for up to two (2)
additional twelve (12) month periods upon not less than twelve (12) months’
prior written notice of each such twelve (12) month extension to ImmunoGen.


 


2.2          Burdened Technology.


 


2.2.1       General.  The Parties hereby acknowledge that certain
ImmunoGen Technology and ImmunoGen Materials, and data and information relating
thereto Controlled by ImmunoGen, may be subject to financial and/or other
contractual obligations to Third Parties incurred by ImmunoGen as a result of
an in-license or similar agreement entered into after the Effective Date (“Burdened
Technology”) and that the use of such Burdened Technology in the Research
Program and the Development and Commercialization of Products resulting from
the Research Program may (i) result in financial or other contractual
obligations of ImmunoGen to Third Parties, or (ii) require that certain notices
or disclosures be made by ImmunoGen to such Third Party as a result of the use
thereof (collectively, the “Burdened Technology Obligations”).  For purposes of clarity, neither the term
“Burdened Technology”, nor the term “Burdened Technology Obligations,” shall
include Limited Targets.  For clarity,
any financial and/or other contractual obligations to Third Parties under
agreements entered into by ImmunoGen on or prior to the Effective Date, that would
have been “Burdened Technology” if entered into after the Effective Date, shall
be the ***** of ImmunoGen.


 


2.2.2       Review of Technology
and Materials.  The Joint Research
Committee shall review all ImmunoGen Technology, ImmunoGen Materials, Aventis
Technology and Aventis Materials that ImmunoGen and Aventis, respectively,
propose to use in the conduct of the Research Program.  To the extent that the Technology or
materials so proposed by ImmunoGen are subject to Burdened Technology
Obligations or constitute Limited Targets, ImmunoGen shall promptly identify
and, subject to any confidentiality obligations it may have to any Third
Parties, describe in reasonable detail to the Joint Research Committee the
extent and nature of such Burdened Technology Obligations or the fact that such
Technology or materials constitute Limited Targets.  Promptly upon receipt of ImmunoGen’s notice, the Joint Research
Committee shall determine whether to include such ImmunoGen Technology,
ImmunoGen Materials, Aventis Technology or Aventis Materials in the Research
Program.  ImmunoGen shall be solely
responsible for any Burdened Technology Obligations that are existing as of the
date such Technology or materials are first used in the conduct of the Research
Program to the extent not identified and described to the Joint Research
Committee prior to such use; it being agreed and understood that ImmunoGen’s
failure to identify and describe Burdened Technology Obligations shall not be
considered a material breach of this Agreement for purposes of


 


18

















 


Section 12.2.3 so long as
the related Technology and materials remain available for use under this
Agreement.


 


2.2.3       Inclusion of
Burdened Technology.  Aventis hereby
agrees that, to the extent that the Joint Research Committee determines to
include any Burdened Technology in the Research Program, and to the extent that
ImmunoGen has identified and described such Burdened Technology Obligation in
reasonable detail to the Joint Research Committee, the Parties will ***** the
***** of ***** for the contractual and/or financial obligations to such Third
Parties which comprise such Burdened Technology Obligations, as necessary to
include such Burdened Technology within the Research Program and/or in the
Development or Commercialization of Products, for so long as such Burdened
Technology is used in the Research Program or to the extent such obligations
are otherwise applicable to the use of such Burdened Technology in the Research
Program and/or is used to Develop or Commercialize Products.  Once any ImmunoGen Technology or ImmunoGen
Materials, including without limitation any Target, Program Antibody, Effector
Molecule or Linker, is recommended by the Joint Research Committee for
inclusion in the Research Program, ImmunoGen will not, without the prior
written consent of Aventis, enter into any agreement with any Third Party that
would result in any such ImmunoGen Technology or ImmunoGen Materials becoming
subject to additional Burdened Technology Obligations with respect thereto or
would result in any such Target becoming a Limited Target.


 


2.3          Joint Research Committee.


 


2.3.1       Formation and
Membership.  As soon as practicable
after the Effective Date, Aventis and ImmunoGen shall establish a Joint
Research Committee (the “Joint Research Committee”) comprised of at
least four (4) representatives designated by Aventis and at least four (4)
representatives designated by ImmunoGen; provided, that, Aventis
and ImmunoGen may designate additional representatives from time to time.  The Joint Research Committee shall include
at least one Development representative from each Party.  Each Party shall be responsible for its own
expenses incurred in connection with attendance by its personnel at any meeting
of the Joint Research Committee.  From
time to time during the Research Program Term, the Joint Research Committee may
establish one or more teams comprised of representatives of both Parties to
implement various aspects of the Annual Research Plan as determined by the
Joint Research Committee (each, a “Joint Research Project Team”).  Such Joint Research Project Teams shall be
governed in the same manner and subject to the relevant requirements as set
forth herein for the Joint Research Committee.


 


2.3.2       Administrative
Matters.  The Joint Research Committee
shall appoint two co-chairpersons from among its members, which positions shall
be filled by one representative of Aventis and one representative of
ImmunoGen.  The co-chairpersons shall be
responsible for calling meetings of the Joint Research Committee and for
leading the meetings.  A Joint Research
Committee member of the Party hosting a meeting of the Joint Research Committee
shall serve as secretary of that meeting. 
The secretary of the meeting shall prepare and distribute to all members
of the Joint Research Committee minutes of the meeting sufficiently in advance
of the next meeting to allow adequate review and comment prior to the
meeting.  Such minutes


 


19

















 


shall provide a description in
reasonable detail of the discussions had at the meeting and a list of any
actions, decisions or determinations approved by the Joint Research
Committee.  Minutes of each Joint
Research Committee meeting shall be approved or disapproved, and revised as
necessary, at the next meeting.  Final
minutes of each meeting shall be distributed to the members of the Joint
Research Committee by the co-chairpersons.


 


2.3.3       Decision Making.  Each Party shall have one vote on the Joint
Research Committee (and each Joint Research Project Team).  Both Parties must vote in the affirmative to
allow the Joint Research Committee (or Joint Research Project Team) to take any
action that requires the vote of the Joint Research Committee or a Joint Research
Project Team, with respect to any actions delegated to a Joint Research Project
Team by the Joint Research Committee. 
If a Joint Research Project Team is unable to reach unanimous agreement
on any matter, such matter shall be referred to the Joint Research
Committee.  If the Joint Research
Committee is unable to reach unanimous agreement within ***** (*****) *****
following the date the matter was first put to a vote, then *****.


 


2.3.4       Meetings.


 


(a)           The Joint Research
Committee shall meet at least four (4) times per Contract Year (except that
proportionately fewer meetings shall be held in a Contract Year with fewer than
12 months).  Such meetings shall be held
at such times and places as are mutually agreed upon by the members of the
Joint Research Committee.


 


(b)           Each Party shall
endeavor to have its representatives attend the meetings of the Joint Research
Committee in person.  If a Party’s
representative is unable to attend a meeting, such Party may attend such
meeting by telephonic or video conference or designate an alternate representative
to attend such meeting in person in place of the absent representative.  In addition, each Party may, at its
discretion, invite additional employees and, with the consent of the other
Party, consultants or scientific advisors, to attend the meetings of the Joint
Research Committee.


 


(c)           Either Party may
also convene a special meeting of the Joint Research Committee for the purpose
of resolving disputes or for the purpose of reviewing (or making) a decision
pertaining to the designation of an Antibody Target as a Program Target, or the
designation of an Antibody or TAP Antibody as a Program Antibody, or the
selection of an Effector Molecule by providing at least ten (10) Business Days
written notice to the other Party.


 


2.3.5       Responsibilities.  The Joint Research Committee shall be
responsible for, among other things:


 


(a)           overseeing the
Research Program;


 


(b)           providing a forum
for consensual decision making;


 


20

















 


(c)           reviewing
recommendations from and advising the Joint Research Project Teams;


 


(d)           preparing and
approving each Annual Research Plan for each Contract Year after Contract Year
1;


 


(e)           appointing one or
more Joint Research Project Teams, as may be appropriate, to implement the
Annual Research Plan;


 


(f)            monitoring the
Parties’ compliance with their respective obligations under the Annual Research
Plan, including the accomplishment of key objectives and the devotion of an
appropriate number of FTEs to the Research Program;


 


(g)           reviewing and approving
any amendments to the Annual Research Plan and evaluating any substantive
departures by either Party from the Annual Research Plan;


 


(h)           reviewing and
approving any amendments to the Antibody Progression Manual, including without
limitation the Lead Selection Criteria;


 


(i)            evaluating any
Burdened Technology Obligations and Limited Targets and deciding whether to
accept Burdened Technology or Limited Targets into the Research Program;


 


(j)            accepting a Target
for inclusion into the Research Program as an Antibody Target, subject to the
limitation set forth in Section 2.8.2(b);


 


(k)           approving selection
of an Antibody Target for designation as a Program Target and identifying any
***** of which such Program Target is a part;


 


(l)            approving
selection of an Antibody or a TAP Antibody for designation as a Program
Antibody;


 


(m)          approving selection
of a Program Antibody for designation as a Lead Antibody;


 


(n)           approving selection
of Effector Molecules and directing the chemical optimization and synthesis thereof;


 


(o)           approving selection
of Linkers;


 


(p)           monitoring reports
submitted by the Parties pursuant to the Annual Research Plan;


 


(q)           reviewing and
commenting upon (but not approving) the patent filing strategies of the Parties
as provided in Article 10 of this Agreement; and


 


21

















 


(r)           approving
recommendations to drop Antibody Targets or Program Targets.


 


2.4          Joint Research Project Teams.


 


2.4.1       Formation of Joint
Research Project Teams.  If the
Joint Research Committee determines to establish a Joint Research Project Team,
Aventis and ImmunoGen shall each make its initial designation of its
representatives not later than ***** (*****) ***** after the formation of such
Joint Research Project Team.  Either Party
may change its designees to any Joint Research Project Team at any time upon
written notice to the other Party.


 


2.4.2       Responsibilities.  Each Joint Research Project Team shall be
responsible for, among other things:


 


(a)           implementing
aspects of the Annual Research Plan assigned to such Joint Research Project
Team by the Joint Research Committee;


 


(b)           recommending to the
Joint Research Committee Antibody Targets as Program Targets;


 


(c)           recommending to the
Joint Research Committee Antibodies and TAP Antibodies for designation as
Program Antibodies;


 


(d)           recommending to the
Joint Research Committee Program Antibodies for designation as Lead Antibodies;


 


(e)           recommending to the
Joint Research Committee Effector Molecules based upon cytotoxicity, ease of synthesis,
patentability and other relevant factors; and


 


(f)            recommending
Linkers to the Joint Research Committee.


 


2.4.3       Special Meeting.  Either Party may convene a special meeting
of the appropriate Joint Research Project Team for the purpose of reviewing (or
making) such recommendations as described in Section 2.4.2 by providing
***** (*****) ***** prior written notice to the other Party.


 


2.5          Conduct of the Research Program.


 


2.5.1       ImmunoGen shall use
Commercially Reasonable Efforts to perform its obligations under the Research
Program in accordance with the Annual Research Plan.  As part of such efforts, during the Research Program Term,
ImmunoGen shall ***** the ***** and ***** necessary to carry out its obligations
under the Annual Research Plan, and shall make available the ***** of ***** in
each year of the Research Program Term as set forth in Section 2.5.3.  In furtherance of the foregoing, the Annual
Research Plan shall set forth the ***** of ***** and by Calendar Quarter (or
partial Calendar Quarter, as the case may be) and


 


22

















 


shall set a ***** related to
the use of Approved Subcontractors by project and by Calendar Quarter (or
partial Calendar Quarter, as the case may be). 
If, at any time during the Research Program Term, ImmunoGen determines
that either the ***** of ***** for a particular Calendar Quarter or the costs
related to the use by ImmunoGen of Approved Subcontractors for a particular
Calendar Quarter or for the Contract Year is expected to exceed the number or
costs set forth in the Annual Research Plan for such Calendar Quarter or for
the Contract Year by ***** (*****) or more, ImmunoGen shall convene a special
meeting of the Joint Research Committee. 
The Joint Research Committee shall then determine whether to ***** the
use of such ***** or such additional Approved Subcontractor services or whether
to ***** the ***** to be *****, such that such ***** or ***** related to the
use by ImmunoGen of Approved Subcontractors are *****.  Such determination of the Joint Research
Committee shall be set forth in a revised Annual Research Plan as a revised
work plan or budget, as the case may be. 
To the extent agreed to by the Joint Research Committee, ***** may be
allocated by the Joint Development Committee to Development activities relating
to Collaboration Products or Licensed Products.  Subject to ImmunoGen’s right to receive the funding described in
Section 2.5.3 below, ImmunoGen shall have the responsibility, at its sole
cost and expense, of paying the ***** and ***** of its *****, including any
***** conducting ***** under the Research Program.  Except as otherwise provided herein, Aventis shall have no
liability as a result of its ***** hereunder to ***** for any *****, *****,
*****, *****, ***** and ***** and ***** and ***** incurred by ***** and *****
with the *****.


 


2.5.2       During the Research
Program Term, Aventis shall use Commercially Reasonable Efforts to perform its
obligations under the Research Program in accordance with the Research Plan.


 


2.5.3       Pursuant to the terms
of this Agreement, Aventis will pay to ImmunoGen funds in the amount of *****
in ***** and ***** and***** in ***** and for any ***** for which the Research
Program Term is extended.  ImmunoGen shall
invoice Aventis for, and Aventis shall fund, a minimum of ***** (*****) *****
in *****, and ***** (*****) ***** in each of ***** and *****.  Subject to Aventis’ right to be reimbursed
pursuant to Section 2.5.6 for any excess amounts paid by Aventis, all such
payments made pursuant to this Section 2.5.3 shall be non-refundable and
non-creditable against any other payments owed by Aventis to ImmunoGen
hereunder.  The Parties shall mutually
agree on the number of ***** to be used for any extension term, based upon the
scope of activities to be performed in the Research Program as so extended; provided,
however, that Aventis may determine not to exercise its option to extend
the Research Program Term in its sole discretion and for any reason including,
without limitation, the failure of the Parties to agree on the number of *****.


 


2.5.4       Within ***** after the ***** of ***** during the Research Program Term
and the ***** following the expiration or termination of the Research Program
Term, ***** will provide to ***** a ***** and ***** the ***** of ***** ***** to
the Research Program during each ***** in such *****, along with ***** and
*****, together with an ***** of the ***** between such ***** and the ***** of
***** for that *****.  Within *****
(*****) days from the date of its ***** of each such *****, ***** will pay to
***** the ***** as *****


 


23

















 


for the ***** by the
*****.  For purposes of clarity and
pursuant to the ***** set forth in Section 2.5.3, but subject to Sections
2.5.6, 12.2.3, 12.2.7 and 15.6 of this Agreement, or except as otherwise
permitted under this Agreement, the ***** to be ***** in *****  will be no less than***** ; the ***** to be
***** in ***** will be no less than ***** and the ***** to be ***** in ***** will
be no less than *****.


 


2.5.5       Within ***** (*****) ***** after the end of each ***** during the
Research Program Term and the ***** following the expiration or termination of
the of the Research Program Term, ImmunoGen will provide to Aventis a report setting
forth the names of the Approved Subcontractors actually applied to the Research
Program during each month in such Calendar Quarter, together with an accounting
of the difference between the budgeted costs and the actual costs for Approved
Subcontractors for that Calendar Quarter. 
Within ***** (*****) ***** from the end of each Calendar Quarter,
ImmunoGen shall provide to Aventis an invoice setting forth the names of such
Approved Subcontractors and the costs incurred and invoiced by such Approved Subcontractors
during such Calendar Quarter.  Within
***** (*****) ***** from the date of its receipt of each such invoice, Aventis
will pay to ImmunoGen any invoice amount due as reimbursement for the work
performed by such Approved Subcontractors to the extent such Approved
Subcontractors are eligible to be used by ImmunoGen in accordance with
Section 2.13 of this Agreement.


 


2.5.6       During the Research Program Term and for a period of ***** (*****) *****
thereafter, ImmunoGen shall keep and maintain, and shall require its Affiliates
and Approved Subcontractors to keep and maintain, accurate and complete
laboratory books and other records of activities performed by ***** in
performing *****, and by each Approved Subcontractor in performing Approved
Subcontractor services, under the Research Program.  In furtherance of the foregoing, ImmunoGen shall keep track of
the activities of ***** on a ***** as determined by ***** in a manner mutually
agreed to by the Parties; it being agreed and understood that ***** to ***** of
***** shall ***** a ***** of the Research Program.  ImmunoGen shall ***** this ***** with respect to all of its *****
and*****.  Not more than ***** per
*****, ***** shall have the right to engage an independent certified public
accounting firm of nationally recognized standing and reasonably acceptable to
ImmunoGen, which shall have the right to examine in confidence the relevant
books, records or other relevant reports, of ImmunoGen and its respective
Affiliates and Approved Subcontractors as may be reasonably necessary to
determine and/or ***** of the ***** to ***** and the ***** of ***** applied to
the ***** of ***** under the Research Program. 
For clarity, such examination shall include, without limitation, the
right of the certified public accounting firm to examine in confidence reports
relating to ***** for all ***** with respect to the Research Program and all of
***** and *****, for the sole purpose of ***** the ***** of the ***** of *****
applied to the ***** of ***** under the Research Program and such accounting
firm may not reveal to Aventis any information with respect to ***** and
*****.  Such examination shall be
conducted, and ImmunoGen shall make its records available, during normal
business hours, after at least ***** (*****) ***** prior written notice shall
have been provided by Aventis to ImmunoGen, as applicable, and shall take place
at the Facility(ies) where such records are maintained.  Each such examination shall be limited to
pertinent books, records or reports for any year ending not


 


24

















 


more than ***** (*****) months
prior to the date of request; provided, that, Aventis shall not
be permitted to audit the same period of time more than once.  Before permitting such independent
accounting firm to have access to such books and records, ImmunoGen may require
such independent accounting firm and its personnel involved in such audit, to
sign a confidentiality agreement (in form and substance reasonably acceptable
to each of the Parties) as to any confidential information which is to be
provided to such accounting firm or to which such accounting firm will have
access, while conducting the audit under this paragraph.  The accounting firm shall provide both
ImmunoGen and Aventis with a written report stating whether the reports
submitted by ImmunoGen are correct or incorrect and the specific details
concerning any discrepancies.  Such
accounting firm may not reveal to Aventis any information learned in the course
of such audit other than the amount of any such discrepancies.  Aventis agrees that all such information
shall be Confidential Information of ImmunoGen and further agrees to hold in
strict confidence all information disclosed to it in accordance with
Article 11 of this Agreement, except to the extent necessary for Aventis
to enforce its rights under this Agreement or if disclosure is required by
law.  If the actual ***** in the *****
of the ***** is ***** than that ***** by ImmunoGen, ImmunoGen shall ***** (but
in no event ***** than ***** (*****) ***** after ImmunoGen’s receipt of the
independent auditor’s report so correctly concluding) ***** Aventis for any
***** by ***** to ***** pursuant to Section 2.5.3.  Aventis shall bear the full cost of such
audit unless such audit ***** the ***** in the ***** of ***** under the *****
to be ***** than that ***** by ***** by ***** (*****) or *****, in which case
ImmunoGen shall ***** for all ***** by ***** in connection with such audit.


 


2.5.7       During the period commencing on the Effective Date and continuing for
the longer of the termination or expiration of this Agreement and ***** (*****)
***** from the date of filing of any patent application pursuant to
Article 10 covering any Product, each Party shall use Commercially
Reasonable Efforts to keep and maintain accurate and complete lab notebooks
reflecting the screening and other research and development activities
performed by such Party under the Research Program.  Upon ***** (*****) ***** prior written notice from a Party, the
other Party shall permit a Third Party patent expert selected by the first
Party and reasonably acceptable to the other Party to examine (at the first
Party’s sole cost and expense) the relevant lab notebooks of the other Party,
as applicable; provided, that, any such Third Party patent expert
shall be required to execute and deliver to the other Party an appropriate
confidentiality agreement covering the information contained in the lab
notebooks to be examined.


 


2.5.8       Each Party shall have
caused or shall cause each participant in the Research Program to execute such
Party’s standard non-disclosure and invention assignment agreement.


 


2.5.9       Each Party shall
identify one of its representatives to serve as a program coordinator with
responsibility for overseeing that Party’s day-to-day activities relating to
the Research Program and to serve as a contact person for coordinating Research
Program activities between the Parties.


 


25

















 


2.5.10     Each Party shall identify
one of its representatives to serve as a program manager with overall
responsibility for achievement of the objectives of the Research Program.  Such program manager shall serve as a member
of the Joint Research Committee and the Joint Development Committee.


 


2.6          Annual Research Plan.


 


2.6.1       The Joint Research Committee shall prepare and approve the Annual
Research Plan for each Contract Year (other than the Contract Year 1) at least
***** (*****) ***** prior to the ***** of such*****.  The Annual Research Plan for the Contract Year 1 is set forth in Exhibit
A to this Agreement.  As noted in
the Annual Research Plan, and as soon as practicable following the Effective
Date but no later than the commencement of Contract Year 1, the Joint Research
Committee shall prepare and approve the budget for Contract Year 1.


 


2.6.2       The Joint Research
Committee shall update and amend, as appropriate, the then current Annual
Research Plan from time to time.


 


2.6.3       Each Annual Research Plan shall contain the specific research objectives
to be achieved during the Contract Year, the specific activities to be
performed under the Research Program and the timeline for performing such
activities, the ***** and ***** of ***** and Approved Subcontractors required
to perform such activities, a detailed budget for performing such activities
and the Party which shall be responsible for performing each of the activities.


 


2.6.4       Each Annual Research
Plan shall be consistent with the other terms and conditions of this Agreement,
including the objectives set forth in Section 2.1.1, and shall be in
substantially the same form, including the items itemized in, the Annual
Research Plan attached as Exhibit A, except that it shall include a
budget.


 


2.7          Materials.


 


2.7.1       Subject to Sections 2.7.2 and 2.8.2 below, during the Research Program
Term, ImmunoGen shall present to the Joint Research Committee for inclusion in
the Research Program all ***** and ***** and *****, and all *****, ***** and
other ***** and ***** related to each of the foregoing in its ***** or in the
***** of which it *****, which ***** reasonably determines, based on its *****
at such time, is ***** to have ***** in the *****.


 


2.7.2       If, during the Research Program Term, ImmunoGen ***** a ***** to the
***** and ***** of ***** (other than a *****) that contains a ***** or other
***** (other than an ***** or *****), then:


 


(a)           ImmunoGen shall have the right to ***** for
***** on its ***** or with a ***** any such ***** that is not ***** any *****
that has ***** for ***** or ***** in the***** ; and


 


26

















 


(b)           ImmunoGen shall have the right to ***** for
***** on its ***** or, subject to clause (ii) below, with a ***** any such
***** that is ***** against any ***** that has ***** for ***** or ***** in the
*****, provided that (i) ImmunoGen shall ***** to ***** such ***** (to
the extent ***** by ***** or in the *****) to the Joint Research Committee
pursuant to Section 2.8.2 and (ii) Aventis shall, at any time prior to the
***** of the ***** of the *****, have a ***** of ***** with respect to *****
pursuant to the procedures set forth in Sections ***** through ***** which
shall apply mutatis mutandis.


 


2.8          Targets.


 


2.8.1       Obligations with
respect to Targets.  During the
Research Program Term and consistent with the Annual Research Plan and the
terms of this Agreement, ImmunoGen and Aventis shall (i) identify and provide
Targets during the Research Program Term for use in the Research Program, (ii)
use Commercially Reasonable Efforts to validate Targets so provided and (iii)
designate such Targets as Antibody Targets pursuant to Section 2.8.2 below
using the technologies, data and materials specified in such Annual Research
Plan.


 


2.8.2       Inclusion of Targets
as Antibody Targets; Limited Targets.


 


(a)           When a Party presents a ***** to the ***** for
***** in the ***** as an*****, such Party shall present to the ***** all *****
and ***** in the ***** of which such Party is ***** or ***** by such Party
relating to the ***** for ***** in the ***** of any such*****.  Within ***** (*****) ***** from the date a
Target is presented to the Joint Research Committee, ImmunoGen shall provide
written notice to the Joint Research Committee if such Target is a Limited
Target.  Such notice shall include the
identity of the type of Limited Target that it is and a reasonably detailed
description of the limitations that would be imposed on Aventis’ rights with
respect to such Limited Target (in each case, the “Limitations”).


 


(b)           In the event that ImmunoGen provides notice within
such ***** (*****) ***** period that such Target is a Limited Target, then the
Joint Research Committee shall promptly determine whether to:


 


(i)            decline to include
such Limited Target in the Research Program and such Limited Target shall not
become an Antibody Target, or


 


(ii)           include such
Limited Target in the Research Program as an Antibody Target subject to the
Limitations identified by ImmunoGen; provided that, in no event shall
such Limitations restrict the rights granted to Aventis in this Agreement with
respect to the research, Development or Commercialization of (A) Antibodies
other than TAP Antibodies (commonly referred to as “naked Antibodies”)
or (B) in the case of any Limited Target other than a Limited Exclusive Option
Target or Limited Exclusive Target, any TAP Antibody containing an Effector
Molecule from a class of molecules other than the maytansinoid class of
molecules.


 


27

















 


(c)           Subject to
Section 2.8.4 below, each Target included in the Research Program as an
Antibody Target shall be subject to the restrictions contained in
Section 7.5.  ImmunoGen shall
promptly notify Aventis and the Joint Research Committee if at any time during
the Research Program Term any Limited Target ceases to be subject to any or all
of the Limitations applicable thereto, whereupon such Limited Target shall be
eligible for inclusion in the Research Program as an Antibody Target, subject
to any remaining Limitations, or if already an Antibody Target, such Limited Target
shall no longer be subject to the particular Limitations that have ceased to be
in effect.


 


(d)           Notwithstanding anything to the contrary set
forth in this Agreement, under no circumstances shall ***** than ***** (*****)
***** be ***** by the ***** as ***** at any ***** during the*****.  For clarity, such ***** of ***** shall not
***** any ***** that would be ***** in the ***** of such ***** upon such *****
becoming a *****.


 


2.8.3       Designation of
Program Targets.  From time to time during the Research Program
Term and no less frequently than at each Joint Research Committee meeting, the
Joint Research Committee shall review all data and information with respect to
each Antibody Target, including any reports as to whether such Antibody Target
may be useful in identifying Antibodies or TAP Antibodies suitable for the
Development of Products in the Collaborative Focus Area.  Promptly following its review, the Joint
Research Committee shall determine whether additional data or information is
required for the Joint Research Committee to make a decision as to whether to
designate such Antibody Target as a Program Target.  If the Joint Research Committee finds that sufficient data and
information have been obtained by the relevant Joint Research Project Teams, the
Joint Research Committee shall provide written notice of same to
ImmunoGen.  The Joint Research Committee
shall, as soon as practicable, but in any event on or before ***** (*****)
***** from the date of such notice, determine in good faith whether to designate
such Antibody Target as a Program Target or to drop such Antibody Target from
the Research Program in accordance with Section 2.8.4 of this Agreement,
which determination and the rationale therefor shall be recorded in the minutes
of the meeting.  The Joint Research
Committee shall prepare and approve an amendment to the Annual Research Plan to
reflect the activities to be undertaken by the Parties with respect to any
Antibody Target that has been designated as a Program Target.


 


2.8.4       Dropped Targets.  If at any time during the Research Program
Term the Joint Research Committee fails to designate any Antibody Target as a
Program Target within the period described in Section 2.8.3, then such
Antibody Target shall be deemed a “Dropped Target.”  In addition, if at any time during the
Research Program Term either Party determines in good faith that the evaluation
of an Antibody Target or Program Target should be discontinued, then either
Party may propose to the Joint Research Committee that the Antibody Target or
Program Target should be dropped from the Research Program.  The Joint Research Committee shall review
each such proposal in good faith and make a determination in favor or against
such proposal as soon as reasonably practicable.  If the Joint Research Committee accepts any such proposal, then,
subject to Section 2.8.3 (in the event that a Lead Antibody has been
Developed


 


28

















 


against such Program Target),
such Antibody Target or Program Target shall thereafter be deemed to be a “Dropped
Target”.


 


2.8.5       Use of Dropped
Targets.  Once a Target becomes a
Dropped Target:


 


(a)           Aventis shall have the right to exploit (i)
any Dropped Target that was ***** for use in the Research Program by ***** and
is not Covered by any Valid Claim of an issued patent within the ***** for any
and all purposes and (ii) any Dropped Target to the extent Covered by any Valid
Claim of an issued patent within the ***** or to the extent obtained by *****
from a ***** and provided by ***** for use in the Research Program in
accordance with Section 2.2 of this Agreement, for the sole purpose of
making, using and selling*****, subject to Sections 8.2.3 and 8.4.3 of this
Agreement.


 


(b)           Subject to Section 2.8.5(a)(ii) above,
ImmunoGen shall have the right to exploit any Dropped Target to the extent
Covered by ***** or to the extent obtained by ***** from a ***** and provided
by ***** for use in the Research Program in accordance with Section 2.2 of
this Agreement, for any purpose other than for the purpose of making, using and
selling *****.


 


(c)           Each Party shall
have the right to exploit any Dropped Target that is part of the public domain.


 


(d)           The exploitation by a Party described in each
of subsections (a)(i), (b) and (c) above shall not require the consent of, nor
trigger any duty to account or make a payment to, the other Party.  The rights of Aventis and of ImmunoGen to
Dropped Targets in each of subsections (a)(i), (b) and (c) above shall include
the rights to all ***** and ***** (together with the specific ***** and *****
to which it is *****) that are ***** against such Dropped Target to the extent
not covered by the intellectual property rights of the other Party.


 


2.9          Research Program Records.


 


2.9.1       All work conducted by
either Party in the course of the Research Program shall be completely and
accurately recorded, in sufficient detail and in good scientific manner, in
separate laboratory notebooks.  On
reasonable notice, and at reasonable intervals, each Party shall have the right
to inspect and copy all such records of the other Party reflecting Program
Technology, Aventis Technology Improvements, ImmunoGen Technology Improvements,
or work done under the Research Program, to the extent reasonably required to
carry out its respective obligations and to exercise its respective rights
hereunder.  Notwithstanding the
definition of “Confidential Information”, all such records shall
constitute Confidential Information of the Party creating such laboratory
notebooks and other records.  The
Parties acknowledge and agree that neither Party guarantees the success of the
Research Program tasks undertaken hereunder.


 


2.9.2       In order to protect the
Parties’ Patent Rights under U.S. law in any inventions conceived or reduced to
practice during or as a result of the Research Program, each


 


29

















 


Party agrees to maintain a
policy which requires its employees to record and maintain all data and
information developed during the Research Program in such a manner as to enable
the Parties to use such records to establish the earliest date of invention
and/or diligence to reduction to practice. 
At a minimum, the policy shall require such individuals to record all
inventions generated by them in standard laboratory notebooks which are dated
and corroborated by non-inventors on a regular, contemporaneous basis.


 


2.10        Disclosure of Research Program
Results.  Subject to restrictions imposed by a Party’s
confidentiality obligations to any Third Party, each Party will disclose to the
other all Program Technology, Aventis Technology Improvements and ImmunoGen
Technology Improvements discovered, invented, or made by such Party during the
course of the Research Program, including, without limitation, information regarding
(i) Targets, Antibodies, TAP Antibodies, Effector Molecules and Linkers
identified in the Research Program through the use of Program Targets, (ii) the
Activity of such Antibodies and TAP Antibodies and any derivatives thereof, and
(iii) the results of in vitro and in vivo studies, assay techniques and new
assays.  Such Program Technology,
Aventis Technology Improvements and ImmunoGen Technology Improvements will be
promptly disclosed to the other Party (including the actual sequence of a
Target or the nucleic or amino acid sequence of an Antibody), with discoveries
or advances being communicated as promptly as practicable after such
information is obtained.  Each Party
will provide the other with copies of the raw data generated in the course of
the Research Program, if reasonably necessary to the other Party’s work under
the Research Program or as requested by the other Party.  Any information disclosed pursuant to this
Section 2.10 may be used by the other Party solely for the purposes of the
Research Program or as otherwise expressly permitted in this Agreement.


 


2.11        Material Transfer.  Except as
otherwise provided under this Agreement, (a) all Aventis Materials or ImmunoGen
Materials delivered to the other Party shall remain the sole property of the
supplying Party and shall be used only in furtherance of the Research Program
under the sole control of the other Party and its Affiliates and (b) a Party
receiving Aventis Materials or ImmunoGen Materials hereunder shall not use such
materials for the benefit of, or deliver such materials to, any Third Party
without the prior written consent of the supplying Party.


 


2.12        Liability. 
In connection with conduct of the Research Program, each Party shall be
responsible for, and hereby assumes, any and all risks of personal injury or
property damage attributable to the negligent acts or omissions of that Party
or its Affiliates, and their respective directors, officers, employees and
agents.


 


2.13        Use of Approved Subcontractors.  Either Party may perform some of its
obligations under the Research Program through one or more Approved
Subcontractors as approved by the Joint Research Committee or Joint Development
Committee, as appropriate; provided, that, (a) none of the rights
of the other Party hereunder are diminished or otherwise adversely affected as
a result of such subcontracting, and (b) the Approved Subcontractor undertakes
in writing all obligations of confidentiality and non-use regarding the other
Party’s Confidential Information which are substantially the same as those
undertaken by Aventis and


 


30

















 


ImmunoGen pursuant to
Article 11 hereof and (c) with respect to ImmunoGen, only those
obligations which ImmunoGen in good faith determines it does not have the
ability and/or reasonable capacity to perform in light of its existing
obligations to Aventis and/or Third Parties shall be eligible for assignment to
an Approved Subcontractor; provided, that with respect to any
such obligations of ImmunoGen described in this clause (c), to the extent that
ImmunoGen does not take actions necessary to enable it to perform such
obligations, then Aventis may, in its sole discretion, perform, or make
arrangements for such obligations to be performed, in which case such obligations
shall not be eligible for assignment to an Approved Subcontractor by
ImmunoGen.  In the event that a Party
performs one or more of its obligations under the Research Program through any
such Approved Subcontractor, then such Party shall at all times be responsible
for the performance by such Approved Subcontractor of such Party’s obligations
hereunder.  Aventis shall reimburse
ImmunoGen pursuant to Section 2.5.5 for payments made by ImmunoGen to Approved
Subcontractors that are eligible to be used by ImmunoGen in accordance with
this Section 2.13.


 


ARTICLE 3



PRECLINICAL AND CLINICAL
DEVELOPMENT PROGRAM


 


3.1          Selection of Lead Antibodies.


 


3.1.1       Notification.  Each Party or the applicable Joint Research
Project Team shall notify the Joint Research Committee in writing when such
Party or Joint Research Project Team determines to recommend that a Program
Antibody should be designated as a Lead Antibody in accordance with the
selection criteria as set forth in the Antibody Progression Manual.  Such notification shall (a) identify the
Program Antibody with specificity and (b) identify the related Program
Target.  Such notification shall be
accompanied by any pertinent data, information, results and materials relating
to the foregoing, which shall be made available to the Joint Research Committee
for review (the “Lead Data Package”).


 


3.1.2       Lead Data Package
Approval.  If the Joint Research Committee determines that the Lead Data Package is
complete and that such Program Antibody meets the Lead Selection Criteria as
set forth in the Antibody Progression Manual, it shall approve the Lead Data
Package and such Program Antibody shall thereafter be designated as a Lead
Antibody, subject to Section 3.4 of this Agreement.  If the Joint Research Committee believes
that the Lead Data Package is incomplete, or it is insufficient to make a
determination as to whether to Develop and Commercialize such Lead Antibody, it
shall promptly, but in no event later than ***** (*****) ***** following
receipt of the Lead Data Package, notify the applicable Party or Joint Research
Project Team and specifically identify any additional data, information,
results or materials that should be provided to the Joint Research Committee
for review.


 


3.1.3       Development of Lead
Antibody.  Aventis shall, as soon as possible after the Joint Research Committee
has designated any Lead Antibody, provide the Joint Research Committee with
written notification of its interest or lack of interest in Developing such
Lead


 


31

















 


Antibody; provided, that,
in no event shall Aventis have the right to ***** more than ***** (*****)
*****, without the prior written consent of ImmunoGen; provided, that,
***** the Joint Research Committee or the Joint Development Committee ***** of
a ***** or *****, Aventis shall have the right to ***** an ***** in *****
thereof.  Subject to the foregoing, if
Aventis desires to pursue the Development of such Lead Antibody, the Parties
shall thereafter conduct Pre-EDC Research Evaluation Activities with respect to
such Lead Antibody.


 


3.2          Designation of an EDC Antibody.  Once
the Joint Research Committee has concluded that the results of Pre-EDC Research
Evaluation Activities applicable to a Lead Antibody support the commencement of
***** as reasonably determined by the Joint Research Committee the Joint
Research Committee shall then make a decision as to whether to designate such
Lead Antibody as an EDC Antibody.


 


3.3          Development of an EDC Antibody into a
Collaboration Product.  Upon designation
of each EDC Antibody by the Joint Research Committee under Section 3.2 of
this Agreement, Aventis shall use Commercially Reasonable Efforts to Develop
such EDC Antibody for the purpose of Commercializing a Product hereunder.


 


3.4          Inclusion of Rights.  Upon designation of a Lead Antibody, the
rights of Aventis to such Lead Antibody shall also include rights to (a) all
***** that are ***** the Target (and the members of the ***** of such Target)
against which such Lead Antibody was directed under the Research Program and
(b) solely to the extent that any such Lead Antibody is a TAP Antibody, all
***** (together with any appropriate *****) from the applicable ***** class(es)
(e.g., *****) for which such TAP Antibody (or any other Program Antibody included
under clause (a) above) has been conjugated.


 


3.5          Joint Development Committee.


 


3.5.1       Formation Of Joint
Development Committee.  As soon as practicable after the Effective
Date, the Parties shall establish a Joint Development Committee (the “Joint
Development Committee”) to provide a forum through which Aventis shall
regularly update ImmunoGen on the Development of all Products and ImmunoGen can
provide suggestions with respect thereto. 
The Joint Development Committee shall include at least ***** (*****)
representatives from each Party.  In
addition, the Joint Development Committee shall follow the organizational and
meeting procedures set forth in Article 2 (including the decision making
procedures set forth in Section 2.3.3) with respect to the Joint Research
Committee, except that the ***** of the Joint Development Committee shall be an
*****.  Each Party shall be responsible
for its own expenses incurred in connection with attendance by its personnel at
any meeting of the Joint Development Committee.  It is understood that ***** will have ***** for ***** the *****
as to the Development of any Product. 
Notwithstanding the foregoing, Aventis shall have the right to make any
final decisions with respect to the Development of Products.  The Joint Development Committee shall not
have the power to amend or waive any compliance by a Party under this
Agreement.


 


32

















 


3.6          Development Activities.  Aventis shall use Commercially Reasonable Efforts to conduct the
Development of all Products and shall be solely responsible for all activities
in connection therewith, including without limitation, engaging any Third Party
to manufacture and supply any Preclinical Materials and/or Clinical Materials
necessary to Develop and Commercialize such Products, as well as all
Development and commercial supplies of the finished Product.  ImmunoGen shall use Commercially Reasonable
Efforts to conduct such Development activities as are requested by the Joint
Development Committee.


 


3.7          Dropped Products.


 


3.7.1       If (a) Aventis
undertakes the Development of a Lead Antibody and thereafter Aventis determines
not to continue to Develop such Lead Antibody or any other Antibody that is
Active against the Target against which such Lead Antibody is Active, and (b)
Aventis determines that the Program Target against which such Lead Antibody is
Active should be dropped from the Research Program, then such Lead Antibody
shall thereafter be deemed a “Dropped Product.”


 


3.7.2       Subject to the provisions of Section 3.8 below, ImmunoGen shall
have the right to exploit for any and all purposes any Dropped Product and (a)
all licenses granted by ImmunoGen to Aventis with respect to such Dropped
Product shall immediately terminate, (b) all obligations of Aventis for any
Burdened Technology Obligations with respect to such Dropped Product shall
terminate, and (c) Aventis shall be deemed to have granted to ImmunoGen the
licenses set forth in Section 7.2.5 with respect to such Dropped Product,
it being understood and agreed that such licenses shall ***** only the *****
with respect to the ***** in its ***** as a ***** and shall not ***** the *****
to use any ***** thereof (i.e., *****, *****, *****, ***** or *****) by
***** or in a ***** other than the *****. 
In addition, Aventis shall promptly transfer to ImmunoGen any related
Drug Approval Applications or Regulatory Approvals related to such Dropped
Product (including transfer of all relevant data and information relevant to
regulatory authorities, if any).


 


3.8          *****;*****.


 


3.8.1       If ImmunoGen desires to ***** an ***** with a ***** for the *****, *****,
or ***** of a Dropped Product, or, if earlier, within ***** (*****) *****
following the ***** of the ***** with respect to a *****, ImmunoGen shall *****
in ***** to ***** the ***** to ***** into an ***** (a “***** “) pursuant
to which ImmunoGen would ***** to ***** a ***** to *****, *****, *****, and
***** such ***** (such ***** being referred to herein as the “*****”).  The ***** shall specify (i) the ***** that
***** to have ***** or ***** subject to such ***** and (ii) all reasonably
relevant ***** and ***** relating to such ***** including, but not limited to,
***** of the *****, if applicable.


 


3.8.2       Within ***** (*****) ***** after provision of an *****, if ***** desires
to ***** into a ***** by such*****, ***** shall send a ***** to such ***** (an
“*****”).  Upon receipt of
an*****, ***** and ***** the ***** of the ***** in ***** for a period not to


 


33

















 


exceed ***** (*****) *****,
which ***** may be ***** in writing by the Parties (the “*****”).


 


3.8.3       If Aventis fails to ***** an ***** within such ***** (*****) *****
period or, if after providing an *****, Aventis fails to ***** to ***** a *****
setting forth ***** for a ***** within ***** (*****) ***** of the date of
issuance of the *****, then ImmunoGen shall be ***** at its option to ***** to
***** such ***** or ***** into an ***** with respect to such ***** with any
***** in accordance with this Section 3.8.


 


3.8.4       ImmunoGen agrees not to ***** or to ***** into any ***** or ***** for a
***** with a ***** during the ***** (*****) ***** period after the ***** or
during the*****.  If ***** and *****,
despite their good faith efforts, do not ***** into a ***** within the *****,
then ***** may at its option ***** to ***** such ***** or ***** into an *****
with a *****, without any further ***** to ***** other than as provided in
Sections 3.8.5 and 3.8.6; provided, however, that if the ***** and *****
of such ***** with such ***** would, taken as a whole, be ***** to ***** than
the ***** by *****, then ***** shall ***** a ***** to*****, whereupon *****
shall have another ***** (*****) ***** period to send a new ***** and, if it
does so, another ***** (*****) ***** therefor. 
The Parties hereby acknowledge and agree that neither ***** nor *****
shall have an obligation to enter into a *****.


 


3.8.5       Notwithstanding anything to the contrary contained in this Agreement, if
ImmunoGen either itself or in collaboration with a Third Party commercializes
any Dropped Product with respect to which a ***** had commenced prior to the
time such Product became a Dropped Product, then ***** shall ***** to ***** a
***** on the ***** of such ***** to ***** (*****).  Such ***** shall be ***** on a ***** for the ***** of *****
(*****) ***** following the ***** of such ***** in such country or, *****,
until the ***** to ***** under ***** existing as of the date ***** became a
***** (a) for any *****, ***** the ***** (i.e., ***** per se ***** only) of any
*****, ***** or ***** of such ***** in such country or (b) for any other *****,
***** such ***** in such *****.


 


3.8.6       With respect to any obligation on the part of ImmunoGen to ***** to
Aventis on account of ***** of a*****, the provisions of ***** shall apply mutatis mutandis.


 


3.9          Use Of Approved Subcontractors.  Aventis may perform its obligations
regarding the Development of Products through one or more Approved
Subcontractors; provided, that, Aventis shall at all times be
responsible for the performance of Aventis’ obligations by such Approved
Subcontractor.


 


34

















 


ARTICLE 4



MANUFACTURE AND SUPPLY


 


4.1          Supply of Preclinical Materials,
Clinical Materials and Product.


 


4.1.1       Aventis shall be
responsible, at its sole cost, for manufacturing or having manufactured any
materials (including without limitation, raw materials) as may be required for
preclinical and clinical studies necessary to obtain Regulatory Approval of
Products and in addition, such materials and/or quantities of each Product as
may be required for all clinical studies applicable to such Product and for
Commercialization of such Product.


 


4.1.2       Notwithstanding the
foregoing, during the Term of this Agreement, Aventis may request ImmunoGen to
supply it with Preclinical Materials, Clinical Materials and/or Products, and
(a) with respect to the supply of Preclinical Materials and Clinical Materials
up to and including for Phase IIB Studies, ImmunoGen shall be responsible for
supplying Aventis with such Preclinical and Clinical Materials, and (b) with
respect to Clinical Materials for Phase III and Phase IV Studies and Product
for Commercialization, Aventis shall have the right to request ImmunoGen to
produce such Clinical Materials and Product in ImmunoGen’s conjugate pilot
plant, in each case subject to the provisions of this Article 4.  Notwithstanding the foregoing, Aventis
acknowledges that ImmunoGen gives no assurances that its conjugate pilot plant
can be modified, validated or obtain the necessary regulatory approval to
enable the production of Products for Commercial sale. In the case that
ImmunoGen’s conjugate pilot plant does not fulfill GMP or other legal or
regulatory requirements to produce Product or materials for Commercialization,
ImmunoGen shall not have any obligation to produce such Product or materials
for Aventis.


 


4.1.3       Upon any request by Aventis pursuant to Section 4.1.2, ImmunoGen
shall provide Aventis with ImmunoGen’s non-binding good faith estimate of the Costs
for supply of such Preclinical Materials, Clinical Materials, or Product, as
applicable.  The Parties shall
thereafter ***** in good faith (a) a ***** (the “*****”) on the ***** under
clause (ii) of the definition of ***** contained herein and ***** under clause
(iv) of the definition of *****, (b) the specifications pursuant to which such
Preclinical Materials, Clinical Materials or Product will be manufactured and
(c) the other material terms and conditions of a separate manufacturing and
supply agreement, consistent with the provisions of Section 4.2.  The Parties acknowledge and agree that (a)
ImmunoGen shall have no obligation to supply Aventis with Preclinical
Materials, Clinical Materials and/or Products until such a manufacturing and
supply agreement has been executed by the Parties with respect to such
Preclinical Materials, Clinical Materials and/or Products and (b) neither
Aventis nor ImmunoGen shall have any obligation to enter into any such
manufacturing and supply agreement if the Parties are unable to agree on the
terms thereof, including the *****.


 


4.2          Manufacturing and Supply Agreement.  The terms of any manufacturing and supply
agreement shall provide, among other things, that: (a) ImmunoGen shall supply
Aventis with such quantities of Preclinical Materials and/or Clinical Materials
as may be reasonably


 


35

















 


requested by Aventis in order
to conduct all preclinical Development and/or clinical activities relating to
any Product; (b) Aventis shall order all amounts of Preclinical Materials,
Clinical Materials and Products, and ImmunoGen shall deliver all such ordered
amounts, in accordance with advance ordering timeframes and delivery timeframes
as agreed upon by the Parties; (c) if ImmunoGen’s conjugate pilot plant
facility is to be utilized, appropriate periodic capacity limits and
allocations as agreed upon by the Parties, such that the manufacture of
Preclinical Material and Clinical Material shall take priority over the
manufacture of Product for Commercial sale; (d) ImmunoGen shall use
commercially reasonable efforts to deliver such amounts of Preclinical
Materials, Clinical Materials and/or Products ordered in accordance with the
foregoing (including such agreed upon timeframes) in a timely manner; and (e)
such quantities of Preclinical Materials, Clinical Materials and Products shall
be manufactured in accordance with all applicable GMP and other legal
requirements and all applicable specifications for the same and shall be
supplied to Aventis at ImmunoGen’s Cost (which term shall include the agreed
upon Overhead Cap).  An appropriate
quality agreement shall be included as part of, or attached as an exhibit to,
such manufacturing and supply agreement.


 


4.3          Purchase of Dedicated Equipment.  If, during the Term of this Agreement,
ImmunoGen determines in good faith that it is necessary or advisable that any
Dedicated Equipment be purchased in order to perform any of its obligations to
manufacture Preclinical Materials, Clinical Materials and/or Products under
Section 4.1 of this Agreement, then ImmunoGen shall request that Aventis
purchase such equipment by providing Aventis with written notice of such
determination, along with the estimated price for such purchase and quality
parameters for the Dedicated Equipment, for Aventis’ approval.  If Aventis approves the purchase of such
Dedicated Equipment, then Aventis shall purchase such equipment and have such
equipment delivered to an ImmunoGen Facility, as directed by the Joint
Development Committee.  In no event
shall the Joint Development Committee require ImmunoGen to purchase Dedicated
Equipment with ImmunoGen’s own funds. 
At any time, Aventis shall have the right to require that ImmunoGen, at
Aventis’ sole cost and expense, transfer any Dedicated Equipment to an Aventis
facility as directed by Aventis.  If
Aventis does not approve the purchase of any Dedicated Equipment, the Parties
shall modify any obligations of ImmunoGen as appropriate to exclude obligations
that would require such Dedicated Equipment.


 


4.4          Use of Approved Subcontractors.  Aventis may perform its obligations
regarding the manufacturing and supply of Products through one or more Approved
Subcontractors; provided, that, Aventis shall at all times be
responsible for the performance by each such Approved Subcontractor of Aventis’
obligations hereunder.


 


ARTICLE 5



REGULATORY MATTERS


 


5.1          Ownership. 
Aventis shall own all Drug Approval Applications and Regulatory
Approvals with respect to all Products.


 


36

















 


5.2          Regulatory Coordination.  Aventis will have exclusive control over, and authority and
responsibility for, the regulatory strategies relating to the development and
commercialization of all Products, including, without limitation (i) the
preparation of all documents submitted to Regulatory Authorities and the filing
of all INDs, Drug Approval Applications and other submissions relating to
Products and (ii) all regulatory actions, communications and meetings with any
Regulatory Authority with respect to any Products.  Subject to any confidentiality obligations of ImmunoGen to Third
Parties, ImmunoGen shall provide to Aventis on a timely basis all information
Controlled by ImmunoGen or otherwise in ImmunoGen’s possession as a result of
its activities under this Agreement or the manufacturing and supply agreement
contemplated by Article 4 which is necessary to enable Aventis to comply
with all regulatory obligations on a global basis applicable to Products,
including without limitation, filing updates, information amendments, annual
reports, pharmacovigilance filings, preclinical research data, preclinical
study reports, investigator notifications and chemistry, manufacturing and
controls information.  All updates and
reports provided hereunder shall be provided in a form as reasonably required
by Aventis for inclusion in any regulatory submission.  Aventis shall be responsible for
interfacing, corresponding and meeting with all Regulatory Authorities with
respect to any Product.  The Parties
shall cooperate with each other to provide all reasonable assistance and take
all actions reasonably requested by the other Party that are necessary or
desirable to comply with any law applicable to any Product, including, but not
limited to, providing Aventis with reasonable access during ordinary business
hours and upon reasonable written notice to ImmunoGen personnel, ImmunoGen
contract research organizations and any facilities at which preclinical studies
were conducted, as reasonably necessary for audit purposes and/or to answer
questions or explain any information ImmunoGen provides pursuant to this
Section 5.2, and the reporting of adverse drug experience reports (and
serious adverse drug experience reports) to Regulatory Authorities pursuant to
Section 5.4 below.


 


5.3          Review of Correspondence for Products. 
Aventis shall use reasonable efforts to provide ImmunoGen with at least
***** (*****) ***** advance notice of any material meeting with the FDA which
is for the purpose of obtaining Regulatory Approval for any Product and
ImmunoGen may elect to send one person reasonably acceptable to Aventis to
participate as an observer (at ImmunoGen’s ***** and *****) in such
meeting.  To the extent reasonably practicable
and subject to any Third Party confidentiality obligations, Aventis shall
provide ImmunoGen with drafts of any material documents or correspondence
pertaining to any Product and prepared for submission to the FDA sufficiently
in advance of submission so that ImmunoGen may review and comment on the
substance of such material documents or correspondence.  Aventis shall promptly provide ImmunoGen
with copies of any material documents or other correspondence received from the
FDA pertaining to any Product.  If
ImmunoGen has not commented on such material documents or correspondence within
***** (*****) ***** of provision of such material documents or correspondence
to ImmunoGen, then ImmunoGen shall be deemed to have no comments on such
material documents or correspondence. 
Aventis agrees to consider all comments in good faith, taking into
account the best interests of the Product on a global basis.


 


37

















 


5.4          Notice of Adverse Events.  Each Party shall provide the other Party with prompt notice of
Adverse Events as follows:


 


5.4.1       Adverse Events.


 


(a)           Aventis agrees to
provide ImmunoGen with (i) Serious Adverse Event information and product
complaint information relating to Products as compiled and prepared by Aventis
in the normal course of business in connection with the Development,
Commercialization or sale of any Product, within time frames consistent with
reporting obligations under applicable laws and regulations and (ii) upon
ImmunoGen’s reasonable request, all other Adverse Event information with
respect to such Products and all other safety data and information relevant to
an analysis or investigation of such Adverse Event; provided, however,
that the foregoing shall not require Aventis to violate any agreements with or
confidentiality obligations owed to any Third Party.


 


(b)           ImmunoGen agrees to
provide Aventis with (i) Serious Adverse Event and product complaint
information relating to any Dropped Product and any product containing any
ImmunoGen Materials (if applicable) that is compiled and prepared by ImmunoGen
or any Third Party in the normal course of business in connection with the
Development, Commercialization or sale of any such product, within time frames
consistent with reporting obligations under applicable laws and regulations and
(ii) upon Aventis’ reasonable request, all other Adverse Event information with
respect to such products and all other safety data and information relevant to
an analysis or investigation of such Adverse Events; provided, however,
that the foregoing shall not require ImmunoGen to violate any agreements with
or confidentiality obligations owed to any Third Party.


 


(c)           Aventis shall
provide its Adverse Event and product complaint information hereunder to
ImmunoGen’s designated representative. 
ImmunoGen shall provide its Adverse Event and product complaint
information hereunder to Aventis’ designated representative.


 


5.4.2       Confidential
Information.  All Adverse Event,
product complaint and other information provided by one Party to the other
Party under this Agreement (including under this Section 5.4), shall be
considered Confidential Information of the disclosing Party, subject to the
terms of Article 11 of this Agreement.


 


ARTICLE 6



COMMERCIALIZATION PROGRAM


 


6.1          Objectives for Commercialization of
Products.  Aventis will have the
sole discretion and exclusive right to promote, sell and distribute Products in
the ROW.  Aventis will have the sole
discretion and exclusive right to promote, sell and distribute Products in the
United States, subject to ImmunoGen’s right to Co-Promoted Products (as defined
below) as set forth in this Article 6.


 


38

















 


6.2          ImmunoGen Option to Co-Promote
Products.  If,
with respect to any Product, ImmunoGen provides written notice of its intent to
participate in the Commercialization of such Product in the United States and
such written notice is received by Aventis within ***** (*****) ***** following
the date of the ***** for such Product, then (a) such Product shall be deemed
to be a “Co-Promoted Product” for purposes of this Agreement and (b)
ImmunoGen and Aventis shall form a commercialization team (the “U.S.
Commercialization Team”) which shall have as its overall purpose the
implementation of Commercialization activities for such Co-Promoted Product in
the United States.  The U.S.
Commercialization Team shall be comprised of an equal number of representatives
from each of Aventis and ImmunoGen, as selected by such Party.  The exact number of representatives of each
Party shall be as determined by Aventis and ImmunoGen.  The chairperson of the U.S.
Commercialization Team shall be a ***** of ***** and shall be responsible for
calling meetings of the U.S. Commercialization Team and for leading the
meetings.


 


6.3          Decision Making; Meetings.  Decisions of the U.S.
Commercialization Team shall be made by unanimous approval of both Parties,
with each Party having one (1) vote on all matters.  If such efforts do not result in mutual agreement on resolution
of the matter, ***** shall have the ***** to ***** a *****, which shall be
deemed the decision of the U.S. Commercialization Team on the issue.  The U.S. Commercialization Team shall meet
at least one (1) time per Calendar Quarter.


 


6.4          Duties. 
The U.S. Commercialization Team shall:


 


(a)           develop and discuss
strategies for the promotion and marketing of each Co-Promoted Product in the
United States, including allocation of responsibility for marketing and
Commercialization activities;


 


(b)           implement the U.S.
portion of the marketing plan as developed by Aventis (the “U.S. Marketing
Plan”);


 


(c)           prepare short term
and long term sales forecasts;


 


(d)           present sales
forecasts and the results of all U.S. Commercialization efforts to the Joint
Steering Committee as needed, but no less often than quarterly;


 


(e)           coordinate the
Detailing efforts of both Parties in the United States;


 


(f)            oversee all
recalls, market withdrawals and any other corrective actions related to each
Co-Promoted Product in the United States;


 


(g)           receive and provide
to the Parties sales reports pertaining to Co-Promoted Products; and


 


39

















 


(h)           perform such
activities as are or may be delegated to the U.S. Commercialization Team
pursuant to this Agreement.


 


6.5          Notice of Number of ImmunoGen Sales Reps.  At
the time ImmunoGen delivers its notice to Aventis of ImmunoGen’s desire to
participate in the Commercialization of a Co-Promoted Product pursuant to
Section 6.2, and thereafter on an annual basis in accordance with the
timetable established by the U.S. Commercialization Team, ImmunoGen shall
inform Aventis of the ***** of ***** that ImmunoGen desires and in good faith
expects to have participate in ***** and ***** Co-Promoted Products in the
United States (“*****”) for the next succeeding Calendar Year and the estimated
***** of ***** that each of these ***** are expected (i) to be ***** and (ii)
to be devoted to ***** products other than Co-Promoted Products during such
Calendar Year.  Aventis shall reimburse
ImmunoGen under Section 6.6 for up to ***** (*****) ***** for *****.


 


6.6          Reimbursement. 
Aventis shall reimburse ImmunoGen
for the cost of up to ***** (*****) ***** for ***** per Calendar Year, and for
such other activities performed by ImmunoGen in accordance with the U.S. Marketing
Plan, calculated as set forth in this Section 6.6.


 


6.6.1       Aventis’ ***** for the ***** of ***** for ***** shall be at a ***** to
be mutually agreed upon by Aventis and ImmunoGen following ImmunoGen’s election
to participate in the Commercialization of the Co-Promoted Product.  The ***** shall be based upon Aventis’ then
***** for its *****.


 


6.6.2       Aventis’ reimbursement for the cost of any activities performed by
ImmunoGen in accordance with the U.S. Marketing Plan shall be ***** to the
***** unless otherwise agreed by the Parties: (a) all payments made to Third
Parties that are approved by the U.S. Commercialization Team and directly
related to conduct of such activities, and (b) the out-of-pocket costs of *****
for use in conducting such activities; provided, however, that if
such Co-Promoted Product is obtained from or through Aventis, it shall be at
Aventis’ ***** for such Co-Promoted Product.


 


6.6.3       Within ***** (*****) ***** prior to the end of each Calendar Quarter
during which ImmunoGen is participating with Aventis in Detailing a Co-Promoted
Product in the United States, ImmunoGen shall submit to Aventis a *****
reasonably detailing ImmunoGen’s good faith estimate of the ***** by ImmunoGen
during such Calendar Quarter, if such ***** did not ***** in the ***** of
Co-Promoted Products for the ***** Calendar Quarter, when such ***** and *****
such *****, whether such individuals participated in the detailing of any
products other than Co-Promoted Products, if such ***** did ***** in the *****
of any such other *****, the ***** that such ***** spend ***** such other *****
versus the time they spent ***** Co-Promoted Products, and any other activities
performed by ImmunoGen in accordance with the U.S. Marketing Plan for which
ImmunoGen is seeking reimbursement hereunder. 
Within ***** (*****) ***** following the end of each Calendar Quarter,
ImmunoGen shall submit to Aventis a final report reasonably detailing the items


 


40

















 


described in the preceding sentence.  Payment of amounts to be reimbursed under
this Section 6.6 shall be made in accordance with the provisions of
Section 9.1.1 below.


 


6.7          Sales Rep Performance. 
ImmunoGen will use Commercially Reasonable Efforts in performing its
designated activities under the U.S. Marketing Plan, and to ensure that its
sales force is adequately trained with respect to Co-Promoted Products to be
co-promoted thereunder.


 


6.8          Booking
Sales.  During
the term of this Agreement, ***** will book ***** sales for all Products in the
Territory and ***** the ***** at which such Products are sold.


 


6.9          Promotional Materials.  In connection with its
marketing and promotion of Co-Promoted Products, ***** shall make and use only
claims, promotional materials, Product samples, advertising and literature
approved by ***** and provided to the U.S. Commercialization Team.


 


6.10        Information Exchange.  Each Party shall keep the U.S.
Commercialization Team reasonably informed as to such Party’s activities in
connection with the marketing, sale, promotion, distribution and other
Commercialization of Co-Promoted Products in the United States.  In addition, ***** shall provide ***** with
***** of Net Sales of all Co-Promoted Products in the United States.


 


6.11        Public Statements Regarding Products.  Each of ImmunoGen and Aventis shall ensure
that no claims or representations in respect of the Co-Promoted Products or the
characteristics thereof are made by or on behalf of it (by members of its sales
force or otherwise) which do not represent an accurate summary or explanation
of the labeling of the Co-Promoted Products or a portion thereof, except to the
extent permitted by Law.


 


6.12        Compliance with Laws.  Each of
ImmunoGen and Aventis agrees to comply with all applicable Laws with respect to
the Commercialization of Co-Promoted Products. 
Neither ImmunoGen nor Aventis shall be required to undertake any
activity relating to the Commercialization of Co-Promoted Products in that it
believes, in good faith, may violate any Law.


 


6.13        Use of Subcontractors. *****
may perform its obligations regarding the Commercialization of Co-Promoted
Products through one or more subcontractors; provided, that,
***** shall at all times be responsible for the performance by its
subcontractor.


 


6.14        Training
Program. ***** will ensure that adequate training programs
are developed for personnel involved in the Commercialization of Co-Promoted
Products in the U.S.; provided, that, (a) ***** shall
participate, as reasonably determined by the Joint Development Committee, in
the preparation of such training materials and conduct of training and (b)
***** shall submit to the U.S. Commercialization Team for its review all such
training materials.  Such training shall
be carried out at a time that is mutually acceptable to the Parties
hereto.  Except as provided herein, it
is agreed that the out-of-pocket costs of the development,


 


41

















 


production and printing of such
training materials shall be borne by *****. 
Each ***** shall bear ***** incurred in participating in the preparation
of such training materials.


 


6.15        Labeling. 
To the extent not prohibited by law or regulation and subject to
approval by the FDA, all product labels for Co-Promoted Products shall include,
in equal prominence, the names of both Aventis and ImmunoGen.


 


ARTICLE 7



LICENSES AND EXCLUSIVITY


 


7.1          ImmunoGen Grants.


 


7.1.1       Activities Under
Research Program.  ImmunoGen hereby
grants to Aventis and its Affiliates, subject to Section 7.1.8 below, a
co-exclusive (with ImmunoGen and its Affiliates), worldwide, royalty-free
license, during the Research Program Term, with the right to grant sublicenses
to Approved Subcontractors, under the ImmunoGen Intellectual Property, to
conduct the Research Program in accordance with the Annual Research Plan.


 


7.1.2       Development Licenses.  On a Lead Antibody, EDC Antibody, Licensed
Antibody and Licensed TAP Antibody basis, ImmunoGen hereby grants to Aventis
and its Affiliates, subject to Section 7.1.8 below, an exclusive (even as
to ImmunoGen and its Affiliates), worldwide, royalty-free license, with the
right to grant sublicenses to Approved Subcontractors, under ImmunoGen
Intellectual Property, to Develop Products.


 


7.1.3       Commercialization
Licenses.  ImmunoGen hereby grants
to Aventis and its Affiliates, subject to Section 7.1.8 below, an
exclusive (even as to ImmunoGen and its Affiliates), worldwide, royalty-bearing
license, with the right to grant sublicenses, under ImmunoGen Intellectual
Property, to Commercialize Products in the Field and in the Territory.


 


7.1.4       Manufacturing
License.  ImmunoGen hereby grants to
Aventis and its Affiliates, subject to Section 7.1.8 below, an exclusive
(even as to ImmunoGen and its Affiliates), worldwide, royalty-free license,
with the right to grant sublicenses to any subcontractor, under ImmunoGen
Intellectual Property, to make and have made Products, including but not
limited to any active pharmaceutical ingredients, Antibodies, TAP Antibodies,
Effector Molecules, Linkers and pharmaceutical dosage forms that comprise such
Product as well as the finished Product.


 


7.1.5       General Research
License; Commercial License.


 


(a)           ImmunoGen hereby grants to Aventis and its
Affiliates a non-exclusive, worldwide, royalty-free license under the ImmunoGen
Patent Rights, to conduct research during the Research Program Term.  The foregoing license shall be ***** by
***** and its *****only upon the ***** of *****, ***** be ***** or *****, *****
no ***** shall be


 


42

















 


required in order for Aventis
or its Affiliates to ***** a ***** to any ***** in connection with the supply
or manufacture of components or materials or the supply or performance of
services.


 


(b)           Upon written request of Aventis at any time
during or after the Research Program Term, ***** shall ***** in ***** with
***** for a period of ***** (*****) ***** the ***** and ***** of a *****
pursuant to which ***** would ***** to ***** a ***** under the ***** to enable
***** to continue to ***** for ***** and *****.  Any such ***** shall be on ***** and ***** to the ***** and *****
then ***** by ***** from ***** to whom ***** in *****.  At the request of *****, such ***** shall include
a ***** on such ***** as the ***** may ***** for ***** to ***** and ***** that
result from ***** of the ***** set forth in this Section 7.1.5.  Notwithstanding the foregoing, in no event
shall either Party be ***** to ***** into any such ***** with the other Party.


 


7.1.6       License With Respect to *****. 
ImmunoGen hereby grants to Aventis and its Affiliates, subject to
Section 7.1.8 below, an exclusive (even as to ImmunoGen and its
Affiliates), worldwide, royalty-bearing license, ***** the ***** to *****,
under ImmunoGen Patent Rights, to develop, make, use and sell ***** in the Field
and in the Territory.


 


7.1.7       License With Respect to ImmunoGen Technology
Improvements.  ImmunoGen hereby grants to Aventis and its
Affiliates a co-exclusive perpetual, irrevocable, worldwide, fully paid,
royalty free license under the ImmunoGen Technology Improvements and all Patent
Rights that Cover any ImmunoGen Technology Improvements, to research, develop
and commercialize any products, and to otherwise commercially exploit such
ImmunoGen Technology Improvements and Patent Rights for any and all purposes.  The foregoing license shall be ***** by
***** and its ***** only upon the ***** of *****, ***** be ***** or *****;
***** no ***** shall be required in order for Aventis or its Affiliates to
***** a ***** to any ***** in connection with the supply or manufacture of
components or materials or the supply or performance of services.


 


7.1.8       Limitation on Scope
of License Grants.  Notwithstanding
anything to the contrary set forth in this Section 7.1, the co-exclusive
licenses granted to Aventis under Sections 7.1.1 and 7.1.7. and the exclusive
licenses granted to Aventis under Sections 7.1.2, 7.1.3, 7.1.4 and 7.1.6 shall
be co-exclusive and exclusive, respectively, but shall be subject to the
Limitations with respect to Limited Targets.


 


7.2          Aventis
Grants.


 


7.2.1       Activities under
Research Program.  Aventis hereby
grants to ImmunoGen and its Affiliates a co-exclusive (with Aventis and its
Affiliates), worldwide, royalty-free license, with the right to grant
sublicenses to Approved Subcontractors, during the Research Program Term, under
the Aventis Intellectual Property and the Program Intellectual Property, to
conduct the Research Program in accordance with the Annual Research Plan.


 


7.2.2       Development Licenses.  On a Lead Antibody, EDC Antibody, Licensed Antibody
and Licensed TAP Antibody basis, Aventis hereby grants to ImmunoGen and its


 


43

















 


Affiliates a non-exclusive,
non-sublicensable, royalty-free license, under the Aventis Intellectual
Property and the Program Intellectual Property, to Develop Products in the
manner and to the extent such Development is assigned to ImmunoGen by the Joint
Development Committee.


 


7.2.3       Co-Promotion License.  On a
Co-Promoted Product-by-Co-Promoted Product basis, Aventis hereby grants to
ImmunoGen and its Affiliates a co-exclusive (with Aventis and its Affiliates),
royalty-free license with the right to grant sublicenses ***** to *****, under
the Aventis Intellectual Property and the Program Intellectual Property, to
co-promote Co-Promoted Products in the United States, in the manner set forth
in the U.S. Marketing Plan for such Co-Promoted Product.


 


7.2.4       Limited Research
License.  Aventis hereby grants to
ImmunoGen and its Affiliates a perpetual, irrevocable, worldwide, non-exclusive,
non-sublicensable, royalty-free, license, under the Program Intellectual
Property to conduct research in the Field.


 


7.2.5       Exclusive License
for Dropped Products.  Subject to
the rights of Aventis contained in Section 3.8 Aventis hereby grants to
ImmunoGen and its Affiliates a worldwide, exclusive (even as to Aventis and its
Affiliates) license under the Aventis Intellectual Property, the Program
Intellectual Property, to the extent required to research, develop, and
commercialize Dropped Products.


 


7.3          Technology Transfer. 
ImmunoGen hereby grants to Aventis and its Affiliates a non-exclusive,
worldwide, royalty-free, perpetual, irrevocable license under (a) any ImmunoGen
Technology or ImmunoGen Materials existing as of the Effective Date and not
Covered by a Valid Claim of the ImmunoGen Patent Rights listed on Schedule 1.50,
and (b) any other ImmunoGen Technology or ImmunoGen Materials not Covered by a
Valid Claim of ***** existing as of the ***** of the *****, in each case to
*****, ***** and ***** any *****, other than *****, ***** or in ***** or *****
with *****, and to ***** such ***** and ***** for ***** and *****.  The foregoing license shall be ***** by
***** and ***** only upon the *****of *****, ***** shall not be ***** or *****;
***** no such ***** shall be ***** in order for ***** or ***** to *****
a ***** to any ***** in connection with the ***** or *****of ***** or ***** or
the ***** or ***** of *****.  The
restrictions on ***** contained in this Section 7.3 and Sections 7.1.5 and
7.1.7 above shall not be deemed to ***** or ***** from *****, and it is
understood that ***** and/or ***** may ***** into, ***** or other ***** with
***** with respect to the *****, ***** and ***** of *****, other than *****,
pursuant to which ***** or ***** may *****, but not ***** except as otherwise
***** or ***** to, (a) the ***** and/or ***** which are ***** under this
Section 7.3 and/or (b) the ***** 
which are ***** under Section 7.1.5(a) above, and/or (c) the *****
which are ***** under Section 7.1.7 above.


 


7.4          Retained Rights.


 


7.4.1       Aventis Retained
Rights.  With respect to this
Agreement, any rights of Aventis not expressly granted to ImmunoGen under the
provisions of this Agreement shall be retained by Aventis.  Without limiting the foregoing, subject to
the other terms of this


 


44

















 


Agreement, including, without
limitation, Section 7.5, Aventis retains the right to use the Aventis
Intellectual Property and the Program Intellectual Property (i) to perform its
work hereunder, (ii) to Develop and Commercialize Products hereunder and (iii)
to research, have researched, develop, have developed, make, have made, use,
have used, sell, offer for sale, have sold, imported and have imported, for any
and all purposes, both alone and together with any Third Party, any product
that is not a Product.


 


7.4.2       ImmunoGen Retained
Rights.  With respect to this
Agreement, any rights of ImmunoGen not expressly granted to Aventis under the
provisions of this Agreement shall be retained by ImmunoGen.  Without limiting the foregoing, subject to
the other terms of this Agreement including without limitation
Section 7.5, ImmunoGen retains the right to use the ImmunoGen Intellectual
Property (i) to perform its work hereunder and to manufacture and supply
Preclinical Materials, Clinical Materials and Products for Aventis, (ii) to
co-promote Co-Promoted Products hereunder and (iii) to research, have
researched, develop, have developed, make, have made, use, have used, sell,
offer for sale, have sold, import and have imported, for any and all purposes,
both alone and together with any Third Party, any product that is not a
Product.


 


7.4.3       No Other Rights.  Except as otherwise expressly set forth in
Section 7.1 and 7.2, nothing in this Agreement shall be construed as a
grant to a Party of any license or other rights with respect to any Technology
(including, without limitation, any Confidential Information) or Patent Rights
Controlled (in whole or in part) by the other Party.


 


7.5          Exclusivity.


 


7.5.1       Neither Party may either, ***** or ***** a *****, ***** any *****or
*****, or ***** in such *****, or any Target against which a ***** is *****
(including without limitation the *****, ***** and *****) for any purpose other
than for the performance of such Party’s obligations and responsibilities under
the relevant Annual Research Plan or this Agreement, except that (a) Aventis
shall have the right to exploit, both within and outside the Collaborative
Focus Area, any such *****, subject to Sections 8.2.3 and 8.4.3 of this
Agreement, if applicable, for the *****of*****, ***** and *****, and (b)
ImmunoGen shall have the right to ***** its ***** to ***** relating to *****
with respect to the *****.


 


7.5.2       During the *****, ImmunoGen shall not ***** or ***** any ***** or other
***** with a ***** such ***** to ***** (or any portion thereof) in the *****,
except for (a) (i) ***** between ***** and ***** as of the ***** relating to
***** and listed on *****, together with a ***** of the ***** of ***** so
*****, and (ii) ***** between ***** and ***** with respect to ***** and *****
as of the ***** and listed on *****, and (b) ***** with *****, in addition to
those described on *****, ***** into after the *****, not to ***** (*****) in  the ***** (the “*****”), that are
***** to those ***** in ***** (*****) ***** (other than ***** to ***** and
*****) that are on a ***** whereby the ***** that is the ***** of such ***** is
***** a ***** or was ***** (as between ***** and such *****) by such
*****;*****, the ***** of ***** shall be ***** by ***** (*****) for each *****
that the ***** is extended, up


 


45

















 


 


to an ***** of ***** (*****)
*****.  In addition, during the *****,
***** shall not ***** any ***** and ***** in the *****, other than with a
*****.


 


7.5.3       During the *****, ***** not ***** into any
***** with a ***** that ***** the ***** to such ***** of exclusive rights to
***** (or any portion thereof) with respect to an entire therapeutic indication
or disease without *****; provided that, following the *****, *****
ability to ***** into any ***** shall ***** to the other ***** contained in
this *****.


 


7.5.4       During the Term of this Agreement, ImmunoGen
shall not, either alone or with a Third Party, develop, manufacture or
commercialize (i) any ***** or ***** that is ***** in a ***** or that is *****
a ***** (or any ***** of the ***** of any *****), or (ii) any *****, except in
each case (a) in the performance of its obligations and responsibilities under
the relevant Annual Research Plan or this Agreement, (b) to the extent included
in a Dropped Product pursuant to Section 3.7 or (c) as necessary to *****
its ***** to ***** relating to the ***** with respect to *****.


 


7.5.5       During the period commencing on the Effective
Date and ***** the ***** of the ***** of 
***** or ***** of the *****, ImmunoGen shall not, either alone or with a
Third Party, develop, manufacture or commercialize any TAP Antibody where the
Effector Molecule of such TAP Antibody is from the taxane class of molecules,
except (i) in the performance of its obligations and responsibilities under the
relevant Annual Research Plan or this Agreement, (ii) to the extent included in
a Dropped Product pursuant to Section 3.7, or (iii) as necessary to *****
its ***** to a ***** relating to the ***** permitting such ***** to ***** to
the relevant ***** or *****, as the case may be, with an ***** from the *****
of *****.


 


7.6          Section 365(n) of the Bankruptcy Code.  All rights and licenses granted under or pursuant
to any Section of this Agreement are, and shall otherwise be deemed to be,
for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights
to “intellectual property” as defined under Section 101(35A) of the
Bankruptcy Code.  The Parties shall
retain and may fully exercise all of their respective rights and elections
under the Bankruptcy Code.  Upon the
bankruptcy of any Party, the non-bankrupt Party shall further be entitled to a
complete duplicate of (or complete access to, as appropriate) any such
intellectual property, and such, if not already in its possession, shall be
promptly delivered to the non-bankrupt Party, unless the bankrupt Party elects
to continue, and continues, to perform all of its obligations under this
Agreement.


 


ARTICLE 8


 


FINANCIAL
PROVISIONS


 


8.1          Upfront Research Payment.  In connection with the funding of research
of Products, Aventis shall pay ImmunoGen, within three (3) Business Days of the
execution of this agreement, Twelve Million Dollars ($12,000,000), which amount
shall be non-refundable and non-creditable. 
For purposes of clarity, in no event shall payments under this
Section 8.1 be credited against the amounts payable under
Section 2.5.3 of this Agreement.


 


46

















 


8.2          Payments.  As
additional funding of research of Products, Aventis shall pay ImmunoGen the
non-refundable and non-creditable amounts set forth below within ***** (*****)
***** following the first occurrence of each event specified below, together with
a copy of any applicable Regulatory Approval letter in connection therewith
(each, an “Event”):


 


8.2.1       Events
and Payments Related to Licensed Products.


 


(a)           *****.  ***** ($*****) upon ***** of
***** of ***** for the ***** of a *****.


 


(b)           *****.  ***** ($*****) upon ***** of
***** of ***** for the ***** of a *****.


 


(c)           *****.  ***** ($*****) upon ***** of
***** of ***** for the ***** of a *****.


 


(d)           *****.  ***** ($*****) upon ***** by
***** of the ***** with the ***** with respect to a *****.


 


(e)           *****.  ***** ($*****) upon ***** of
the ***** by the ***** with respect to a *****; provided that if, at the
***** of *****, the ***** by Section ***** above was ***** to the *****
that ***** had been ***** on any ***** at the time of *****, then the ***** to
be ***** by ***** under this Section 8.2.1(e) shall be ***** by *****
($*****) for a ***** under this subsection (e) of ***** ($*****).


 


(f)            *****.  ***** ($*****) upon ***** of
the ***** and ***** of a ***** in any ***** of the *****, whether by the *****
(by the ***** for ***** of ***** (*****)) in the ***** or by the ***** in the
***** of the ***** in the *****.


 


(g)           *****.  ***** ($*****) upon ***** of
the ***** and ***** of a ***** in *****.


 


For
purposes of clarification, (i) each of the ***** shall be ***** and upon the
***** of each ***** for each *****, ***** of the ***** of ***** of each *****
for such *****, (ii) ***** or ***** shall be ***** the ***** for purposes of
this Section 8.2.1 if ***** are ***** at the *****, (iii) *****, *****,
***** or ***** for a ***** for which a ***** has been made shall not *****,
(iv) in no event shall ***** under this Section 8.2.1 be ***** any *****
under Section ***** of this Agreement, and (v) “*****” with respect to a
***** shall mean the ***** the ***** is ***** with a ***** in *****.


 


8.2.2       Events
and Payments Related to Collaboration Products.


 


(a)           *****.  ***** ($*****) upon the ***** by the *****
pursuant to Section ***** of a ***** as an ***** for ***** into a *****.


 


47

















 


(b)           *****.  ***** ($*****) upon ***** of ***** of *****
for the ***** of a *****.


 


(c)           *****.  ***** ($*****) upon ***** of ***** of *****
for the ***** of a *****.


 


(d)           *****.
***** ($*****) upon ***** of ***** of ***** for the ***** of a *****.


 


(e)           *****.  ***** ($*****) upon ***** by ***** of the
***** with the ***** with respect to a *****.


 


(f)            *****.  ***** ($*****) upon ***** of the ***** by
the ***** with respect to a *****; provided that if, at the ***** of
*****, the ***** required by Section ***** above was ***** to the *****
that ***** had been ***** on any ***** at the time of *****, then the ***** to
be ***** by ***** under this Section 8.2.2(f) shall be ***** by *****
($*****) for a ***** under this subsection (f) of ***** ($*****).


 


(g)           *****.  ***** ($*****) upon ***** of the ***** and
***** of a ***** in any ***** of the *****, whether by the ***** (by the *****
for ***** of ***** (*****)) in the ***** or by the ***** in the ***** of the
***** in the *****.


 


(h)           *****.  ***** ($*****) upon ***** of the ***** and
***** of a ***** in *****.


 


For purposes of clarification, (i) each of the ***** shall be made
***** and upon the ***** of each ***** for each *****, ***** of the ***** of
***** of each ***** (ii) ***** or ***** shall be *****the *****for purposes of
this Section 8.2.2 if such *****are *****at the*****, (iii) *****, *****,
***** or ***** for a ***** shall not *****, (iv) in no event shall ***** under
this Section 8.2.2 be ***** any ***** under Section ***** of this
Agreement and (v) “*****” with respect to a ***** shall mean the ***** the
***** is ***** with of a ***** in *****.


 


8.2.3       *****.  If (i) the ***** for such ***** constitutes
***** and is not a *****, (ii) a ***** for such ***** is ***** under this
Agreement but such ***** becomes a ***** after an ***** has been ***** with
respect thereto and (iii) the ***** by ***** of such ***** would ***** a *****
under the *****, then:


 


(a)           *****.  ***** ($*****) upon ***** of  ***** of ***** for the ***** of *****.


 


(b)           *****.  ***** ($*****) upon ***** of  ***** of ***** for the ***** of *****.


 


(c)           *****.  ***** ($*****) upon the ***** in the *****
by ***** of *****.


 


48

















 


(d)           *****.  ***** ($*****) upon the ***** by ***** in
any ***** of the ***** of *****.


 


(e)           *****.  ***** ($*****) upon the ***** by ***** in
***** of *****.


 


For purposes of clarification, (i) each of the ***** shall be made
***** and upon the ***** of each ***** for each *****, ***** of the ***** of *****
of each *****, (ii) ***** (*****) or ***** shall be ***** the ***** for
purposes of this Section 8.2.3 if such ***** are ***** at the *****, (iii)
*****, *****, ***** or ***** for an ***** shall not *****, (iv) in no event
shall ***** under this Section 8.2.3 be ***** any ***** under
Section ***** of this Agreement and (v) “*****” with respect to a *****
shall mean the ***** the ***** is ***** with ***** in *****.


 


8.3          Determination
That Payments Are Due.  Aventis shall provide ImmunoGen with prompt
written notice upon its achievement of each of the Events set forth in
Section 8.2 of this Agreement.  In
the event that, notwithstanding the fact that Aventis has not given any such
notice, ImmunoGen believes any such Event has occurred, it shall so notify
Aventis and the Joint Development Committee in writing, and shall provide to
Aventis and the Joint Development Committee the data and information
demonstrating that the conditions for payment have been achieved.  Within ***** (*****) ***** of its receipt of
such notice, the Joint Development Committee shall review the data and
information and shall certify in writing whether or not the conditions for
payment have been achieved.  Any
negative determination shall be accompanied by a detailed explanation of the
reasons therefor.


 


8.4          Royalties.


 


8.4.1       Licensed
Products.  Subject to the provisions
of this Section 8.4, Aventis shall pay the following royalties (“Licensed
Product Royalties”) on a Licensed Product-by-Licensed Product basis based
on aggregate, worldwide, annual Net Sales of each Licensed Product, as follows:


 


(a)           *****
(*****) of that ***** of ***** of such ***** that is ***** than or ***** to
$***** in a *****.


 


(b)           *****
(*****) of that ***** of ***** of such ***** that is ***** than $***** but *****
than or ***** to $***** in a *****.


 


(c)           *****
(*****) of that ***** of ***** of such ***** that is ***** than $***** in a
*****.


 


8.4.2       Collaboration
Products.  Subject to the provisions
of this Section 8.4, Aventis shall pay the following royalties (“Collaboration
Product Royalties”) on a Collaboration Product-by-Collaboration Product
basis based on aggregate, worldwide, annual Net Sales of each Collaboration
Product, as follows:


 


49

















 


(a)           *****
(*****) of that ***** of ***** of such ***** that is ***** than or ***** to
$***** in a *****.


 


(b)           *****
(*****) of that ***** of ***** of such ***** that is ***** than $***** but
***** than or ***** to $***** in a *****.


 


(c)           *****
(*****) of that ***** of ***** of such ***** that is ***** than $***** in a
*****.


 


8.4.3       *****.  Subject to the provisions of this
Section 8.4.3, Aventis shall pay the following royalties (“*****”
and together with the ***** and the *****, the “*****”) on a ***** -
***** based on *****, *****, ***** of each *****, as follows:


 


(a)           If
(i) the ***** for such ***** constitutes ***** and is either (x) a ***** or (y)
a ***** for a ***** that is ***** prior to the ***** of an ***** with respect
thereto and (ii) the ***** by ***** of such ***** would ***** a ***** under the
*****, then ***** (*****) of the ***** of such *****;


 


(b)           If
(i) (A) the ***** for such ***** constitutes ***** and is not a *****, (B) a
***** for such ***** is ***** and ***** under this Agreement for which *****
and ***** will be ***** under this Agreement, and (C) the ***** by ***** of
such ***** would ***** a ***** under the *****, or (ii) the ***** meets the
***** set forth in Section *****, then (x) ***** (*****) of that ***** of
***** of such ***** that is ***** than or ***** to $***** in a *****, (y) *****
(*****) of that ***** of ***** of ***** that is ***** than $***** but *****
than or ***** to $***** in a *****, and (z) ***** (*****) of that ***** of
***** of such ***** that is ***** than $***** in a *****.


 


(c)           If
(i) the ***** for such ***** is brought to the ***** by ***** from a ***** and
constitutes ***** of such *****, (ii) the ***** by ***** of such ***** would
***** a ***** of a ***** of such ***** such ***** and (iii) no other ***** are
due and payable pursuant to Section ***** or ***** hereof with respect to
such *****, then ***** (*****) of the ***** of such *****.


 


8.4.4       Royalty Term.


 


(a)           Subject
to the provisions of Section 8.4.5 below, with respect to Products
containing TAP Antibodies, Aventis shall pay to ImmunoGen the Royalties set
forth in Sections 8.4.1 and 8.4.2 on a Product-by-Product basis and a
country-by-country basis for so long as there exists in such country a Valid
Claim within any ImmunoGen Patent Rights or Program Patent Rights ***** the
***** of ***** (i.e., ***** per se ***** only) of any ***** or ***** of
such ***** Product, or, if longer, until the ***** (*****) ***** of the First
Commercial Sale of such Product in a given country; provided  that,
subject to Section 8.4.5(d), such Royalties shall be ***** by ***** (e.g.
a ***** (*****) ***** shall be ***** to ***** and ***** (*****)) solely for
that portion of the royalty payment term during which no such ***** exists in
such *****.


 


50

















 


(b)           Subject
to the provisions of Section 8.4.5 below, with respect to Products other
than those containing TAP Antibodies, Aventis shall pay to ImmunoGen the
Royalties set forth in Sections 8.4.1 and 8.4.2 on a Product-by-Product basis
and a country-by-country basis for so long as there exists in such country a
Valid Claim within any ImmunoGen Patent Rights or Program Patent Rights which
***** the *****, a ***** thereof or the ***** of ***** of such ***** in such
*****, or, if *****, until the ***** (*****) ***** of the ***** of such *****
in a given country; provided that, subject to Section 8.4.5(d),
such Royalties shall be ***** by ***** (e.g. a ***** (*****) ***** shall be
***** to ***** and ***** (*****)) solely for that portion of the royalty payment
term during which no such ***** exists in such *****.


 


(c)           Subject
to the provisions of Section 8.4.5 below, with respect to *****, *****
shall ***** to ***** the ***** set forth in Section ***** on a ***** basis
and a ***** basis for so long as there ***** in such ***** a ***** under the
***** (or under a ***** of a ***** in the case of Section *****) which
***** the ***** of such ***** in such *****.


 


(d)           For
purposes of clarity, Royalties are determined on a country-by-country basis
such that, if Aventis is no longer obligated to pay a Royalty in a given
country with respect to a Product, ***** from the sale of such Product in such
country shall not be ***** in *****, or the *****, under Sections 8.4.1, 8.4.2
and 8.4.3 above.


 


8.4.5       Additional
Royalty Reductions.  The Royalties
payable hereunder shall be subject to the following additional reductions:


 


(a)           If
(i) ***** is ***** to ***** a ***** under ***** of a ***** in order to *****
the ***** thereof, or other ***** of a ***** in order to ***** thereof, in
either case, in connection with the*****, ***** or ***** of a ***** (other than
***** or ***** related to the ***** of *****generally), and (ii) such *****
would be required by any company desiring to *****, ***** or ***** that
incorporate the ***** related to *****, *****or *****of *****or*****, then,
subject to Section 8.4.5(c), Aventis may ***** the ***** of any *****,
***** or other ***** made to such ***** for such *****.  Aventis shall use *****to *****any such
***** on ***** that, in ***** determination, are as ***** as then available.


 


(b)           If
a ***** (other than ***** required under Section 8.4.5(a)) under ***** or
other ***** of a ***** (other than ***** or ***** related to the ***** of *****
generally) is necessary to ***** or ***** a *****, then, subject to
Section 8.4.5(c), ***** may ***** of the amount of any *****, ***** or
other ***** made by ***** to such ***** for such ***** from Royalties payable
hereunder; provided, that (i) the foregoing reduction shall not
apply to any ***** or ***** rights ***** subject matter whose ***** is a *****
in the ***** of ***** of *****, unless ***** an ***** in such ***** of *****
for the future Development or Commercialization of the Product, in which case,
if such ***** is applied to ***** of *****, other than the Product, then such
Royalty reduction shall be based on a ***** of the license to the Product; and
(ii) in no event shall ***** provisions of this Section 8.4.5(b) ***** the
***** (in each *****) hereunder by more than ***** (*****) *****.  To the extent any such ***** or other *****
(other than *****) ***** by ***** under this Section 8.4.5(b) are not able
to be ***** by ***** in the ***** in which they are ***** by *****, then *****
may continue such ***** in ***** until such ***** or other ***** is *****.


 


51

















 


(c)           In
no event shall all ***** provisions of Sections 8.4.4 and 8.4.5(a) and (b)
***** the ***** hereunder to ***** than ***** (*****) of *****.


 


(d)           All
Royalties then in effect on a Product in a particular country shall be ***** by
***** (e.g., a ***** (*****) ***** shall be ***** to ***** and ***** (*****))
during the ***** (as defined below) in the event that a ***** sells a ***** (as
defined below) in such *****.  For
purposes of this Section 8.4.5(d), a “*****” shall mean a *****,
other than any ***** on the ***** as of the Effective Date, which includes an
***** or *****, as applicable, that is ***** against the ***** as a ***** and
the term “*****” shall mean the ***** during which the ***** of the
***** by such ***** in the relevant ***** are ***** to at ***** (*****) of
***** or ***** of the relevant ***** in such *****.


 


(e)           All
Royalties then in effect on a Product in a particular country shall ***** on
the ***** of (i) the ***** on which the ***** of ***** in such ***** are *****
to at least ***** (*****) of ***** or ***** of the relevant ***** in such
*****, or (ii) the ***** on which a ***** is ***** in such country where the
laws or regulations of such ***** permit ***** of ***** of a *****.  For purposes of this Section 8.4.5, a “*****”
shall mean a ***** that ***** the same ***** as a ***** (*****may vary) and is
***** to such *****.


 


(f)            If
***** reasonably and in good faith believes that a ***** is required in order
to permit Aventis to Commercialize a Product in a particular ***** with a
*****, ***** may notify ***** of such belief and its basis therefor and, if
such notification is made, the Parties shall ***** as ***** as ***** to discuss
in good faith whether a ***** to the ***** for such ***** in such ***** is
appropriate.


 


8.4.6       Development
Costs.  Except as otherwise provided
in this Agreement, Development costs for all Products shall be borne one
hundred percent (100%) by Aventis.


 


52

















 


ARTICLE 9


 


ROYALTY
PAYMENTS; REPORTING; BOOKS AND RECORDS


 


9.1          Reports and Payments.


 


9.1.1       Statements
and Payment.  Aventis shall deliver to ImmunoGen, within
thirty (30) days after the end of each Calendar Quarter, a report setting forth
for such Calendar Quarter the following information for each Product: (i) Net
Sales of such Product or *****, on a country-by-country basis, (ii) the basis
for any reductions to the Royalties payable due to the application of Sections
8.4.3 and 8.4.4, as applicable (iii) the Royalties due to ImmunoGen on account
of sales of such Product or *****, and (iv) the exchange rates used in
calculating any of the foregoing.  The
total Royalties due on account of sales of Products or ***** during such
Calendar Quarter, plus any amounts due as reimbursement for ***** pursuant to
Section 6.6, shall be remitted at the ***** is *****.


 


9.1.2       Taxes
and Withholding.  Any payments made by Aventis to ImmunoGen
under this Agreement shall be free and clear of any taxes, duties, levies, fees
or charges, and such amounts shall be reduced by the amount required to be paid
or withheld pursuant to any applicable law, including, but not limited to,
United States federal, state or local tax law (“Withholding Taxes”).  Any such Withholding Taxes required by law
to be paid or withheld shall be an expense of, and borne solely by,
ImmunoGen.  Aventis, as applicable,
shall submit to ImmunoGen reasonable proof of payment of the Withholding Taxes,
together with an accounting of the calculations of such taxes, within *****
(*****) ***** after such Withholding Taxes are remitted to the proper
authority.  The Parties will cooperate
reasonably in completing and filing documents required under the provisions of
any applicable tax laws or under any other applicable law in connection with
the making of any required tax payment or withholding payment, or in connection
with any claim to a refund of or credit for any such payment.


 


9.1.3       Currency
Exchange.  With respect to Net Sales
invoiced or expenses incurred in U.S. dollars, the Net Sales or expense amounts
and the amounts due to ImmunoGen hereunder shall be expressed in U.S.
dollars.  With respect to Net Sales
invoiced or expenses incurred in a currency other than U.S. dollars, the Net
Sales or expense shall be expressed in the domestic currency of the entity
making the sale or incurring the expense, together with the U.S. dollar
equivalent, calculated using the arithmetic average of the spot rates on the
last Business Day of each month of the Calendar Quarter in which the Net Sales
were made or the expense was incurred. 
The “closing mid-point rates” found in the “Dollar spot forward against
the Dollar” table published by The Financial Times, or any other
publication as agreed to by the Parties, shall be used as the source of spot
rates to calculate the average as defined in the preceding sentence.  All payments shall be made by wire transfer
in U.S. dollars to the credit of such bank account as shall be designated at
least five (5) Business Days in advance by ImmunoGen in writing to Aventis.


 


9.1.4       Maintenance
of Records; Audit.  For a period of ***** (*****) *****, Aventis
shall keep and maintain, and shall require its respective Affiliates and
sublicensees to


 


53

















 


keep and maintain, such accurate and complete
books and records in connection with the sale of Products hereunder, as are
necessary to allow the accurate calculation consistent with generally accepted
accounting principles of the Royalties due to ImmunoGen, including any records
required to calculate any royalty adjustments hereunder.  ***** per *****, ImmunoGen shall have the
right to engage an independent certified public accounting firm of nationally
recognized standing and reasonably acceptable to Aventis, which shall have the
right to examine in confidence the relevant books and records of Aventis and
its respective Affiliates and sublicensees as may be reasonably necessary to
determine and/or verify the amount of Royalty payments due hereunder.  Such examination shall be conducted, and
Aventis shall make its records available, during normal business hours, after
at least ***** (*****) ***** prior written notice to Aventis, as applicable,
and shall take place at the facility(ies) where such records are
maintained.  Each such examination shall
be limited to pertinent books and records for any year ending not more than
***** (*****) ***** prior to the date of request; provided, that,
ImmunoGen shall not be permitted to audit the same period of time more than
once.  Before permitting such
independent accounting firm to have access to such books and records, Aventis
may require such independent accounting firm and its personnel involved in such
audit, to sign a confidentiality agreement (in form and substance reasonably
acceptable to each of the Parties) as to any confidential information which is
to be provided to such accounting firm or to which such accounting firm will
have access, while conducting the audit under this paragraph.  The ImmunoGen independent accounting firm
will prepare and provide to each Party a written report stating whether the
Royalty reports submitted and Royalties paid are correct or incorrect and the
specific details concerning any discrepancies. 
Such accounting firm may not reveal to ImmunoGen any information learned
in the course of such audit other than the amount of any such
discrepancies.  ImmunoGen agrees to hold
in strict confidence all information disclosed to it, except to the extent
necessary for ImmunoGen to enforce its rights under this Agreement or if
disclosure is required by law.  In the
event there was an underpayment by Aventis hereunder, Aventis shall promptly
(but in no event later than ***** (*****) ***** after such Party’s receipt of
the independent auditor’s report so correctly concluding) make payment to
ImmunoGen of any shortfall.  In the
event that there was an overpayment by Aventis hereunder, ImmunoGen shall
promptly (but in no event later than ***** (*****) ***** after ImmunoGen’s
receipt of the independent auditor’s report so correctly concluding) refund to
Aventis the excess amount.  ***** shall
bear the ***** of such audit unless such audit discloses an underreporting by
Aventis of more than ***** (*****) of the aggregate amount of Royalties in any
***** (*****) ***** period, in which case, Aventis shall reimburse ImmunoGen
for all costs incurred by ImmunoGen in connection with such examination and
audit.


 


9.1.5       Overdue
Royalties. In the event that any payment for Royalties due hereunder is not
made when due, the payment shall accrue interest from the date due at a rate
equal to the average one-month London Interbank Offered Rate (LIBOR) for the US
Dollar, as published by The Financial Times or any other
publication as mutually agreed to by the Parties, plus one hundred (100) basis
points, calculated on the number of days between the actual date the payment is
made and the date the payment was due; provided, however, that in no event
shall such rate exceed the maximum annual interest rate permitted under
applicable Law.


 


54

















 


ARTICLE 10


 


INTELLECTUAL
PROPERTY OWNERSHIP,

PROTECTION AND RELATED MATTERS


 


10.1        Aventis Intellectual Property Rights.  Aventis shall have sole and exclusive
ownership of all right, title and interest on a worldwide basis in and to any
and all Aventis Intellectual Property, with full rights to license or
sublicense, subject to the licenses to ImmunoGen as set forth herein and
subject to the provisions of Section 7.5.


 


10.2        ImmunoGen Intellectual Property Rights.  ImmunoGen shall have sole and exclusive
ownership of all right, title and interest on a worldwide basis in and to any
and all ImmunoGen Intellectual Property, with full rights to license or
sublicense, subject to the licenses to Aventis as set forth herein and subject
to the provisions of Section 7.5.


 


10.3        Program Intellectual Property Rights.  *****
shall have ***** and ***** of all *****, subject to ***** granted to ***** as
set forth herein and subject to the provisions of Section *****.


 


10.4        Prosecution and Maintenance of Patent Rights.


 


10.4.1     Aventis
shall be responsible for (a) preparing, filing and prosecuting patent
applications (including reissue, continuing, divisional, and substitute
applications and any foreign counterparts thereof), (b) for maintaining any
Patent Rights, and (c) for managing any interference or opposition proceedings
relating to the foregoing (“Patent Prosecution”) Covering any Aventis
Intellectual Property or Program Intellectual Property.  ImmunoGen shall be responsible for Patent
Prosecution for ImmunoGen Intellectual Property.  All Patent Prosecution expenses, including attorneys’ fees,
incurred by a Party in the performance of Patent Prosecution shall be borne by
such Party.


 


10.4.2     Except with respect to Aventis Intellectual
Property, with respect to which ImmunoGen shall not have rights under this
Section, if the prosecuting Party elects not to continue pursuing Patent
Prosecution with respect to any rights within Patent Rights (and the other
Party has rights under such Patent Right), then the prosecuting Party shall
notify the other Party in writing of such election at least ***** (*****) *****
prior to the last available date for action to preserve such Patent Rights.  If such other Party elects to continue
Patent Prosecution, such other Party may do so at its sole expense.  If ImmunoGen is the Party that elects not to
continue pursuing Patent Prosecution and Aventis elects to continue such Patent
Prosecution, then (a) such affected Patent Rights shall not be considered a
Valid Claim hereunder and no Royalties shall be payable by Aventis to ImmunoGen
hereunder with respect to the affected Patent Rights in such country and (b)
Aventis shall be entitled to offset the costs of such Patent Prosecution
against Royalties, if any, due to ImmunoGen hereunder for sales of Products in
such country.  For clarity, in the event
that Aventis incurs such costs of Patent Prosecution and there are not
sufficient Royalties to fully offset such costs in the ***** in which such
costs are incurred, ImmunoGen shall have no obligation to make a payment to
Aventis for such costs;


 


55

















 


provided that, Aventis may continue such offsets in
subsequent ***** until such costs are fully recovered.


 


10.5        Cooperation.  Each Party hereby agrees:


 


10.5.1     to
make its employees, agents and consultants reasonably available to the other
Party (or to the other Party’s authorized attorneys, agents or
representatives), to the extent reasonably necessary to enable the prosecuting
Party to undertake Patent Prosecution,


 


10.5.2     to
provide the other Party with copies of all material correspondence with the
U.S. Patent and Trademark Office or its foreign counterparts pertaining to
Patent Prosecution for Program Patent Rights and Patent Rights Covering
ImmunoGen Technology Improvements as to which such Party has a license under
this Agreement reasonably in advance of any relevant filing deadline or
intended filing date for such other Party to review and comment thereon, to
incorporate, absent a substantial reason to the contrary, the non-filing
Party’s comments on such filing before submitting such filing to the relevant
patent authority, and to provide the other Party a copy of all material notices
received from a patent authority with respect thereto;


 


10.5.3     to
cooperate, if necessary and appropriate, with the other Party in gaining patent
term extensions wherever applicable to Program Patent Rights; and


 


10.5.4     to
endeavor in good faith to coordinate its efforts with the other Party to
minimize or avoid interference with the Patent Prosecution of the other Party’s
patent applications.


 


10.6        Third Party Infringement.


 


10.6.1     Notice.  Each Party shall promptly provide the other
Party with written notice reasonably detailing any known or alleged
infringement by a Third Party of Program Patent Rights, Aventis Patent Rights,
ImmunoGen Patent Rights or Patent Rights Covering either ImmunoGen Technology
Improvements or Aventis Technology Improvements.


 


10.6.2     Products.


 


(a)           *****
shall have the first right, but not the obligation, to institute and direct
legal proceedings against any Third Party believed to be infringing the Program
Patent Rights.  All costs, including
attorneys’ fees, relating to such legal proceedings shall be borne by *****.


 


(b)           *****
shall have the first right, but not the obligation, to institute and direct
legal proceedings against any Third Party believed to be infringing the
ImmunoGen Patent Rights or Patent Rights Covering ImmunoGen Technology
Improvements.  All costs, including
attorneys’ fees, relating to such legal proceedings shall be borne by *****.


 


56

















 


(c)           Any
damages, monetary awards or other amounts recovered, whether by judgment or
settlement, pursuant to any suit, proceeding or other legal action taken under
this Section 10.6.2, shall be applied as follows:


 


(i)            First,
to reimburse the Parties for their respective costs and expenses (including
reasonable attorneys’ fees and costs) incurred in prosecuting such enforcement
action;


 


(ii)           Second,
to Aventis in reimbursement for lost sales associated with Products and to
ImmunoGen in reimbursement for lost Royalties owing hereunder based on such
lost sales;


 


(iii)         Third,
any amounts remaining shall be allocated as follows:  (a) if ImmunoGen is the Party bringing such suit or proceeding or
taking such other legal action, ***** (*****) to ImmunoGen, (b) if Aventis is
the Party bringing such suit or proceeding or taking such other legal action,
***** (*****) to Aventis, and (c) if the suit is brought jointly, ***** (*****)
to each Party.


 


10.6.3     Cooperation
In Patent Infringement Proceedings. 
In the event that either Aventis or ImmunoGen takes action pursuant to
this Section 10.6, the other Party shall cooperate to the extent
reasonably necessary and at the first Party’s sole expense.  Upon the reasonable request of the Party
bringing such action, such other Party shall join the suit and shall be
represented in any such legal proceedings using counsel of its own choice, at
the first Party’s expense.  Neither
Party shall settle any claim or proceeding relating to Program Patent Rights,
ImmunoGen Patent Rights or Patent Rights Covering ImmunoGen Technology
Improvements Controlled in whole or in part by the other Party or licensed
under this Agreement to the other Party without the prior written consent of
such other Party, which consent shall not be unreasonably withheld.


 


10.6.4     Back-Up
Enforcement Rights.  If the Party
having the first right under this Section 10.6 with respect to a Program
Patent Right, ImmunoGen Patent Right or Patent Rights Covering ImmunoGen
Technology Improvements fails to institute and prosecute an action or
proceeding to abate the infringement within a period of ***** (*****) *****
after receiving written notice or otherwise having knowledge of the
infringement as provided above (or ***** (*****) ***** if such action is
brought under the Hatch-Waxman Act), then the other Party shall have the right,
but not the obligation, to bring and prosecute any such action if it is
licensed under such Patent Right pursuant to this Agreement, or Controls such
Patent Right.  Any recovery of damages
and costs in any such action brought pursuant to this Section 10.6.4 shall
be shared by the Parties equally to the extent arising out of the competitive
product infringement that gave rise to a Party’s ability to bring such action
under this Section 10.6.


 


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10.7        Other Intellectual Property Infringement.


 


10.7.1     Notice.


 


(a)           Each
Party shall notify the other in writing of any allegations it receives from a
Third Party that Program Intellectual Property, ImmunoGen Intellectual
Property, Aventis Intellectual Property or any Product infringes the
intellectual property rights of such Third Party.  Such notice shall be provided promptly, but in no event after
more than ***** (*****) *****, following receipt of such allegations.


 


(b)           In
the event that a Party receives notice that it or any of its Affiliates have
been individually named as a defendant in a legal proceeding by a Third Party
alleging infringement of a Third Party patent or other intellectual property
right as a result of the manufacture, production, use, development, sale or distribution
of Program Intellectual Property, ImmunoGen Intellectual Property or any
Product, such Party shall immediately notify the other Party in writing and in
no event notify them later than ***** (*****) ***** after the receipt of such
notice.  Such written notice shall
include a copy of any summons or complaint (or the equivalent thereof) received
regarding the foregoing.


 


(c)           Each
Party shall provide to the other Party copies of any allegations of alleged
patent invalidity or non-infringement of a patent or patents with respect to
Program Intellectual Property, ImmunoGen Intellectual Property or any Product
pursuant to a Paragraph IV Patent Certification or equivalent certification by
a Party filing for an approval of a generic product.  Such copies shall be provided promptly, but in any event within
***** (*****) *****, of receipt of such certification.


 


(d)           Each
Party shall provide to the other Party copies of any notices it receives from
Third Parties regarding any patent nullity actions, any declaratory judgment
actions, any alleged infringement of Program Intellectual Property, ImmunoGen
Intellectual Property or any Product. 
Such notices shall be provided promptly, but in no event after more than
***** (*****) *****, following receipt thereof.


 


10.7.2     In
all cases where a claim is made by a Third Party and for which notice was given
in accordance with Section 10.7.1, ***** shall determine the appropriate
course of action for such Product.


 


10.8        Marks for Products.


 


10.8.1     Aventis
shall own all trademarks and service marks associated with Commercializing a
Product (collectively, “Marks”). 
Aventis shall also own any domain names including any Marks.  Under no circumstances shall Aventis acquire
any rights under this Section 10.8 in any trademark or service mark
including the word “ImmunoGen.”


 


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10.8.2     Aventis
shall grant to ImmunoGen a license to such Marks solely for the purposes of
performing its obligations and exercising its rights, if any, relating to the
Commercialization of a Co-Promoted Product in the Territory.


 


10.8.3     Except
as expressly stated in this Agreement, ImmunoGen shall not have any right,
title, interest or other license in or to any of the Marks, and all uses of
such Marks shall inure solely to the benefit of Aventis.


 


10.8.4     ImmunoGen
agrees not to contest the validity of, by act or omission jeopardize, or take
any action inconsistent with, Aventis’ rights or goodwill in any of its Marks
in any country, including, without limitation, attempted registration of any
such Mark, or use or attempted registration of any confusingly similar names,
trademarks or logos.


 


10.8.5     In
the event that ImmunoGen becomes aware of any infringement of a Mark in the
United States by a Third Party, it shall promptly notify Aventis.


 


ARTICLE 11


 


CONFIDENTIALITY;
NON-SOLICITATION


 


11.1        Confidential Information.  Except in connection with the activities
contemplated by this Agreement, Confidential Information disclosed by a Party
to the other Party during the term of this Agreement shall not be used by the
receiving Party, shall be maintained in confidence by the receiving Party and
shall not otherwise be disclosed by the receiving Party to any other person,
firm, or agency, governmental or private (other than a Party’s Affiliates),
without the prior written consent of the disclosing Party, except to the extent
that the Confidential Information (as determined by competent documentation):


 


11.1.1     was
known or used by the receiving Party or its Affiliates prior to its date of
disclosure to the receiving Party; or


 


11.1.2     either
before or after the date of the disclosure to the receiving Party is lawfully
disclosed to the receiving Party or its Affiliates by sources other than the
disclosing Party rightfully in possession of the Confidential Information; or


 


11.1.3     either
before or after the date of the disclosure to the receiving Party or its
Affiliates becomes published or generally known to the public (including
information known to the public through the sale of products in the ordinary
course of business) through no fault or omission on the part of the receiving
Party, its Affiliates or its sublicensees; or


 


11.1.4     is
independently developed by or for the receiving Party or its Affiliates without
reference to or reliance upon the Confidential Information.  In addition, the provisions of this
Section 11.1.4 shall not preclude the receiving Party or its Affiliates
from disclosing Confidential Information to the extent such Confidential
Information is required to be disclosed by the receiving Party or its
Affiliates to comply with applicable laws, to defend or prosecute


 


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litigation or to comply with
governmental regulations, provided that the receiving Party provides prior
written notice of such disclosure to the disclosing Party and takes reasonable
and lawful actions to avoid and/or minimize the degree of such disclosure.  Specific information shall not be deemed to
be within any of the foregoing exclusions merely because it is embraced by more
general information falling within these exclusions.


 


11.2        Exception for Disclosure of Tax Treatment.  Notwithstanding anything else in this
Agreement to the contrary, each Party hereto (and each employee,
representative, or other agent of any Party) may disclose to any and all
persons, without limitation of any kind, the Federal income tax treatment and
Federal income tax structure of any and all transaction(s) contemplated herein
and all materials of any kind (including opinions or other tax analyses) that
are or have been provided to any Party (or to any employee, representative, or
other agent of any party) relating to such tax treatment or tax structure,
provided, however, that this authorization of disclosure shall not apply to
restrictions reasonably necessary to comply with securities laws.  This authorization of disclosure is
retroactively effective immediately upon commencement of the first discussions
regarding the transactions contemplated herein, and the Parties aver and affirm
that this tax disclosure authorization has been given on a date which is no
later than thirty (30) days from the first day that any Party hereto (or any
employee, representative, or other agent of any party hereto) first made or
provided a statement as to the potential tax consequences that may result from
the transactions contemplated hereby.


 


11.3        Employee and Advisor Obligations.  ImmunoGen and Aventis each agree that they
shall provide Confidential Information received from the other Party only to
their respective employees, consultants and advisors, and to the employees,
consultants and advisors of such Party’s Affiliates, who have a need to know
and have a written obligation to treat such information and materials as
confidential in a substantially similar manner to that reflected in the
confidentiality obligations of the Parties contained herein.


 


11.4        Term.  All obligations of
confidentiality imposed under this Article 11 shall expire ***** (*****)
***** following termination or expiration of this Agreement.


 


11.5        Publications. 
Each Party shall consult with the other Party prior to the submission of
any manuscript for publication if the publication will contain any Confidential
Information of the other Party, unless the applicable laws and regulations
prohibit such consultation.  Such
consultation shall include providing a copy of the proposed manuscript to the
other Party at least ***** (*****) ***** prior to the proposed date of
submission to a publisher, incorporating appropriate changes proposed by the
other Party regarding its Confidential Information into the manuscript
submission and deleting all Confidential Information of the other Party as it
may request; provided however, that the other Party’s review hereunder
shall be deemed to be completed at the end of such ***** (*****) *****
period.  The review period shall be
extended for an additional ***** (*****) ***** in the event the non-publishing
Party can demonstrate a reasonable need for such extension including, but not
limited to, the preparation and filing of patent applications.  Each Party shall provide to the other Party
the opportunity to review any proposed abstracts, manuscripts or summaries of
presentations which cover the


 


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results of the Research Program
or of the Development of a Product. 
Each Party shall designate a person who shall be principally responsible
for approving such publications.


 


11.6        Prohibition on Solicitation.  Without the written consent of the other Party,
neither Party nor its Affiliates shall, during the Research Program Term and
for a period of one year following the expiration or termination of the
Research Program Term, solicit (directly or indirectly) any person who was
employed by the other Party or its Affiliates at any time during the Research
Program Term and was primarily dedicated to the Research Program to terminate
his or her employment with such Party or its Affiliates and become employed by
such other Party.  This provision shall
not restrict either Party or its Affiliates from advertising employment
opportunities in any manner that does not directly target the other Party or
its Affiliates.


 


ARTICLE 12


 


TERM AND
TERMINATION


 


12.1        Term.


 


12.1.1     This
Agreement shall become effective as of the Effective Date and, unless earlier
terminated by mutual agreement of the Parties or as set forth in this
Article 12, this Agreement will continue in full force and effect on a
country-by-country and product-by-product basis until the obligation to pay
royalties with respect to the sale of such product in such country expires or
is earlier terminated in accordance with the terms hereof.


 


12.1.2     On a
country-by-country basis and on a Product-by-Product basis and a ***** -by-
***** basis, upon the scheduled expiration (as contemplated in
Section 8.4.4) of Aventis’ obligation to pay Royalties with respect to the
sale of such Product or ***** in such country, the licenses granted under
Section 7.1, with respect to a given Product or ***** shall become fully paid
up, royalty-free, perpetual and irrevocable.


 


12.1.3     On
a country-by-country basis and on a Dropped Product-by-Dropped Product basis,
upon the scheduled expiration (as contemplated in Section 3.8.5) of
ImmunoGen’s obligation to pay royalties with respect to the sale of such
product in such country, the licenses granted under Section 7.2.5 shall
become fully paid up, royalty-free, perpetual and irrevocable.


 


12.2        Material Breach; Termination.


 


12.2.1     Material
Breach.  If either Party believes
that the other Party (the “Breaching Party”) is in material breach of
this Agreement (including without limitation any material breach of a
representation or warranty made in this Agreement), then the non-breaching
Party may deliver notice to the Breaching Party specifying the material
breach.  For all breaches other than a
failure to make a payment set forth in Article 8, the allegedly Breaching
Party shall have ***** (*****) ***** to either cure such breach or, if cure cannot
be reasonably effected within such ***** (*****) ***** period, to deliver to
the other Party a plan for curing such breach that is reasonably sufficient to
effect a cure within ***** (*****) *****. 
Such a plan


 


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shall set forth a program for achieving
cure as rapidly as practicable. 
Following delivery of such plan, the Breaching Party shall use diligent
efforts to carry out the plan and cure the breach.  For any breach arising from a failure to make a payment set forth
in Article 8 hereof, the allegedly Breaching Party shall have *****
(*****) ***** to cure such breach.  If
any material breach is not cured as specified above, then the provisions of
Sections 12.2.2, 12.2.3, 12.2.4 and 12.2.5 shall apply.


 


12.2.2     Consequences
of Material Breach by Aventis Relating to the Research Program.  If a material breach of Aventis relates to
the Research Program and is not cured in accordance with Section 12.2.1,
then ImmunoGen shall have the right to terminate the Research Program.  Upon such termination, this Agreement shall
continue in full force and effect with respect to Aventis’ further Development
and Commercialization of any Product then existing at a ***** or *****
(including the payment of Royalties and Event based payments).  For purposes of clarity, if ImmunoGen
terminates the Research Program:


 


(a)           the
licenses granted under Sections *****, *****, ***** and ***** shall terminate;


 


(b)           the
provisions of the ***** only of Section ***** shall apply; and


 


(c)           ImmunoGen
will have no further obligations to perform activities under the Research
Program or at the direction of the Joint Development Committee and Aventis will
have no further funding obligations for the Research Program.


 


12.2.3     Consequences
of Material Breach by ImmunoGen Relating to the Research Program.  If a material breach of ImmunoGen relates to
the Research Program and is not cured in accordance with Section 12.2.1,
then Aventis shall have the right at its option to reduce or terminate
ImmunoGen’s participation in the Research Program by ***** the ***** to *****
the ***** of ***** (which ***** may be to *****) to be utilized in the Research
Program and the obligation of Aventis to ***** a ***** of ***** shall
terminate.


 


12.2.4     Consequences
of Material Breach by Aventis Relating to a Product.  If the material breach of Aventis relates to
the Development or Commercialization of a Product and is not cured in
accordance with the provisions of Section 12.2.1, then:


 


(a)           such
Product shall be deemed a Dropped Product;


 


(b)           ImmunoGen
shall have the rights thereto as set forth in Section 3.7; provided
that Aventis shall not have the right to receive the royalty set forth in
Section 3.8.5 and shall not have the right of first negotiation with
respect to such Product as set forth in Sections 3.8.1 through 3.8.4;


 


(c)           if
the Product is then being Commercialized, the Parties will take reasonable
steps necessary to ensure that ImmunoGen has sufficient commercial supplies of
such Product for a period of ***** (*****) ***** from the effective date of such
termination; and


 


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(d)           upon
ImmunoGen’s request, Aventis shall grant to ImmunoGen an exclusive, worldwide
license to utilize any of the Marks which were used exclusively to market the
affected Product in ***** for a ***** from ***** to ***** to be ***** in *****
by the Parties not to ***** a ***** of ***** (*****) of ***** of such Products
***** by ImmunoGen or any of its Affiliates, licenses or sublicenses using any
of such Marks.


 


12.2.5     Consequences
of Material Breach by ImmunoGen Relating to a Co-Promoted Product.  If the material breach by ImmunoGen relates
to the Commercialization of a Co-Promoted Product and is not cured in
accordance with the provisions of Section 12.2.1, then the license set forth
in Section 7.2.3 shall terminate with respect to that Co-Promoted Product
and ImmunoGen shall have no further right to co-promote that Co-Promoted
Product.


 


12.2.6     Exclusive
Remedy.  The rights of the
non-breaching Party set forth in Sections 12.2.2 through 12.2.4 shall be the
exclusive legal remedy to a Party arising from a material breach other than the
failure to make a payment; provided, however, that (i) in
addition to the above described legal remedy, the Parties may seek any and all
equitable remedies, including without limitation declarative and injunctive
relief in accordance with applicable law and (ii) this restriction shall not
prevent either Party from seeking indemnification pursuant to Article 15.


 


12.2.7     Rights
of Aventis Upon *****.  At any time during Research Program Term,
Aventis may at its option terminate this Agreement in its entirety or terminate
the Research Program upon ***** (*****) ***** prior written notice to ImmunoGen
in the event that the Joint Research Committee, the Joint Development Committee
or the Joint Steering Committee determines that ***** and ***** that could
reasonably result from the Research Program would be, ***** on *****, ***** to
***** such that no ***** could ***** be ***** to *****.  If this Agreement or the Research Program is
terminated by Aventis pursuant to this Section 12.2.7, then on or before
the effective date of such termination, ***** shall ***** to *****, in ***** an
***** to the ***** for ***** specified to be ***** to the ***** under the then
***** for the ***** (*****) ***** the delivery of Aventis’ written notice to
ImmunoGen and Aventis shall have ***** for the Research Program and (b) all
***** of ImmunoGen set forth in Sections ***** 
and ***** of this Agreement shall immediately terminate.  Alternatively, Aventis shall have the option
to ***** the ***** to ***** the ***** on ***** other than ***** and to *****
the ***** of ***** to be ***** in the ***** to a number appropriate in light of
the ***** to be ***** under such *****, in which case the obligation of Aventis
to ***** a ***** of *****.


 


12.3        Certain Rights Upon Scheduled Expiration of the Research
Program Term.  Upon the
scheduled expiration of the Research Program Term:


 


12.3.1     All
Antibody Targets that have not been designated as Program Targets and all
Program Targets against which no Antibodies or TAP Antibodies have been
generated as of the expiration of the Research Program Term shall be deemed to
be Dropped Targets and the Parties shall have the rights to such Targets as set
forth in Section 2.8.5.  With
respect to any such Targets that are ***** by *****, ***** shall have the *****
to ***** that ***** in *****


 


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for a period of ***** (*****)
***** the ***** and ***** of a ***** with respect to such *****.  The consideration for any ***** such *****
shall be as agreed to in such ***** and the ***** and ***** contained herein
shall not be ***** with respect thereto.


 


12.3.2     All
*****, all ***** against which such ***** are ***** and all ***** in the *****
of such ***** shall remain subject to the restrictions contained in
Section *****, and available to Aventis for ***** and ***** under this
Agreement.


 


12.4        Residual Rights; Survival.  Upon expiration or termination of this
Agreement, except as specifically provided herein to the contrary, all rights
and obligations of the Parties under this Agreement shall cease, except as
follows:


 


12.4.1     Obligations
to pay amounts accruing hereunder up to the date of expiration or termination;


 


12.4.2     The
obligations regarding confidentiality as set forth in Article 11;


 


12.4.3     All
obligations for record keeping and accounting reports;


 


12.4.4     The
Parties’ right to inspect books and records of each other as set forth in
Section 9.1.4;


 


12.4.5     The
Parties’ rights with respect to the ownership of intellectual property as set
forth in Article 10;


 


12.4.6     Obligations
of defense and indemnity, which obligations shall continue in full force and
effect for an unlimited period;


 


12.4.7     In
addition to the provisions of Sections 12.1.2 and 12.1.3, the licenses granted
pursuant to Sections *****, *****, *****, *****, *****, *****, *****, ***** and
***** shall survive.


 


ARTICLE 13


 


JOINT STEERING
COMMITTEE


 


13.1        Joint Steering Committee.


 


13.1.1     As
soon as practicable after the Effective Date, Aventis and ImmunoGen shall
establish a Joint Steering Committee comprised of at least three (3) senior
executives of Aventis and at least three (3) senior executives of ImmunoGen.


 


13.1.2     The
Joint Steering Committee shall meet at least two (2) times annually to review
the efforts of the Parties in the conduct of the Research Program and
Development and Commercialization activities.


 


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13.1.3     The
location of such meetings of the Joint Steering Committee shall be as agreed by
the Parties.  The Joint Steering
Committee may also meet by means of a telephone conference call or by
videoconference.


 


13.1.4     Each
Party may change any one or more of its representatives to the Joint Steering
Committee at any time upon written notice to the other Party.


 


13.1.5     Each
Party shall use commercially reasonable efforts to cause its representatives to
attend the meetings of the Joint Steering Committee.  If a representative of a Party is unable to attend a meeting,
such Party may designate an alternative to attend such meeting in place of the
absent representative, and such alternate shall have full voting power at such
meeting.


 


13.1.6     In
addition, each Party may, at its discretion, invite non-voting employees, and,
with the consent of the other Party, consultants or scientific advisors, to
attend meetings of the Joint Steering Committee.


 


13.1.7     Decisions of
the Joint Steering Committee shall be made by unanimous consent of Aventis and
ImmunoGen, with each Party having one vote, through written consent, through
any other mutually agreed upon affirmative electronic form of consent, or at a
regularly scheduled meeting or any other meeting held for such purpose.  If the Joint Steering Committee is unable to
reach unanimous agreement within ***** (*****) ***** following the date the
matter was first put to a vote, then ***** have the ***** to ***** the
*****.  Either Party may convene a
special meeting of the Joint Steering Committee for the purpose of resolving
disputes.


 


13.2        Chairperson of
the Joint Steering Committee.  The chairperson of the Joint Steering
Committee shall be a representative of ***** and shall be responsible for
calling meetings of the Joint Steering Committee and for leading the meetings.


 


ARTICLE 14


 


REPRESENTATIONS,
WARRANTIES AND COVENANTS


 


14.1        Representation of Authority; Consents.  ImmunoGen and Aventis each represent and
warrant to the other Party that as of the Effective Date (a) it is a
corporation duly organized and validly existing under the laws of its
jurisdiction of incorporation, (b) it has full right, power and authority to
enter into this Agreement, (c) this Agreement has been duly executed by such
Party and constitutes a legal, valid and binding obligation of such Party,
enforceable in accordance with its terms, and all necessary consents, approvals
and authorizations of all government authorities and other persons required to
be obtained by such Party in connection with the execution, delivery and
performance of this Agreement have been and shall be obtained, and (d) it has
the full right, power and authority to grant the licenses granted to the other
under Section 7 hereof.


 


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14.2        No Conflict.  Each Party represents to the other Party, as
of the Effective Date, that the execution and delivery of this Agreement and
the performance of such Party’s obligations hereunder (a) do not conflict with
or violate such Party’s corporate charter and bylaws or any requirement of
applicable laws of regulations, and (b) do not and shall not in any material
respect conflict with, violate or breach or constitute a default or require any
consent under, any contractual obligation of such Party provided, that
ImmunoGen makes no representations or warranties under this
Section 14.2(b) with respect to Limited Targets and Burdened Technology,
which matters are the subject to Section 14.4.


 


14.3        Knowledge of Pending or Threatened Litigation.  Each Party represents and warrants to the
other Party that there is no claim, investigation, suit, action or proceeding
pending or, to such Party’s knowledge, expressly threatened, against such Party
before or by any governmental entity or arbitrator that, individually or in the
aggregate, could reasonably be expected to (i) materially impair the ability of
such Party to perform any obligation under this Agreement or (ii) prevent or
materially delay or alter the consummation of any or all of the transactions
contemplated hereby.


 


14.4        Disclosure of Certain Agreements.  ImmunoGen represents that ***** is true,
complete and correct in all material respects.


 


14.5        Disclaimer of Warranty. 
NEITHER PARTY MAKES ANY EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR USE OR PURPOSE, QUALITY OR USEFULNESS OF ANY TARGET,
PROGRAM ANTIBODY, LEAD ANTIBODY, EDC ANTIBODY, LICENSED PRODUCT OR
COLLABORATION PRODUCT.  EXCEPT AS
OTHERWISE PROVIDED HEREIN, ALL IMMUNOGEN MATERIALS ARE PROVIDED “AS IS,” AND
IMMUNOGEN MAKES NO EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR
A PARTICULAR USE OR PURPOSE, QUALITY OR USEFULNESS OF ANY IMMUNOGEN TECHNOLOGY
OR IMMUNOGEN MATERIALS.  EXCEPT AS
OTHERWISE PROVIDED HEREIN, ALL AVENTIS MATERIALS ARE PROVIDED “AS IS,” AND
AVENTIS MAKES NO EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR USE OR PURPOSE, QUALITY OR USEFULNESS OF ANY AVENTIS TECHNOLOGY OR
AVENTIS MATERIALS.


 


14.6        Additional ImmunoGen Representations, Warranties
and Covenants.  ImmunoGen
represents, warrants and covenants to Aventis that:


 


14.6.1     all
Patent Rights included within the ImmunoGen Patent Rights listed on Schedule 1.50
are existing and, to its best knowledge, are not invalid or unenforceable, in
whole or in part;


 


14.6.2     as
of the Effective Date, ImmunoGen has the right to (i) use and license the
ImmunoGen Intellectual Property as is necessary to fulfill its obligations
under this


 


66

















 


Agreement and to grant the
licenses to Aventis pursuant to this Agreement, and (ii) except as set forth on
Schedule 14.6.2, enforce all Patent Rights listed on Schedule 1.50.


 


14.6.3     (i)
all inventors of any inventions included within the ImmunoGen Patent Rights
listed on Schedule 1.50 have assigned their entire right, title and
interest in and to such inventions and the corresponding Patent Rights to
ImmunoGen and (ii) to the best knowledge of ImmunoGen, no Person, other than
those Persons named as inventors on any patent or patent application included
within such ImmunoGen Patent Rights, is an inventor of the invention(s) claimed
in such patent or patent application;


 


14.6.4     as
of the Effective Date, there are no claims, judgments or settlements against
ImmunoGen pending or, to its best knowledge, threatened, seeking to invalidate
the ImmunoGen Patent Rights listed on Schedule 1.50 and during the
term of this Agreement, ImmunoGen shall promptly notify Aventis in writing upon
learning of any actual or threatened claim, judgment or settlement with respect
to the ImmunoGen Patent Rights; and


 


14.6.5     as
of the Effective Date, to the best of its knowledge, (a) the *****, ***** or
***** the ***** as ***** will not ***** a ***** of any ***** in ***** as of the
*****; provided that ***** is made as to the ***** of ***** by ***** to
***** in writing during ***** to the *****, and (b) no ***** is ***** the
*****.


 


ARTICLE 15


 


MISCELLANEOUS
PROVISIONS


 


15.1        Indemnification.


 


15.1.1     Aventis.  Aventis agrees to defend ImmunoGen and its
Affiliates at Aventis’ cost and expense, and will indemnify and hold ImmunoGen
and its Affiliates and their respective directors, officers, employees and
agents (the “ImmunoGen Indemnified Parties”) harmless from and against
any losses, costs, damages, fees or expenses arising out of any Third Party
claim relating to (i) any material breach by Aventis of any of its
representations, warranties or obligations pursuant to this Agreement, (ii) the
gross negligence or willful misconduct of Aventis, or (iii) injuries resulting
from the development, manufacture, use, sale or other disposition by Aventis of
any Product or ***** (other than as set forth in Section 15.1.2(iii)
below).  In the event of any such claim
against the ImmunoGen Indemnified Parties by any Third Party, ImmunoGen shall
promptly notify Aventis in writing of the claim and Aventis shall manage and
control, at its sole expense, the defense of the claim and its settlement.  The ImmunoGen Indemnified Parties shall
cooperate with Aventis and may, at their option and expense, be represented in
any such action or proceeding.  Aventis
shall not be liable for any litigation costs or expenses incurred by the
ImmunoGen Indemnified Parties without Aventis’ prior written
authorization.  In addition, Aventis
shall not be responsible for the indemnification or defense of any ImmunoGen
Indemnified Party arising from any negligent or intentional acts by any
ImmunoGen Indemnified Party or the breach by ImmunoGen of any obligation or


 


67

















 


warranty under this Agreement,
or any claims compromised or settled without its prior written consent.


 


15.1.2     ImmunoGen.  ImmunoGen agrees to defend Aventis and its
Affiliates at ImmunoGen’s cost, and will indemnify and hold Aventis and its
Affiliates and their respective directors, officers, employees and agents (the
“Aventis Indemnified Parties”) harmless from and against any losses,
costs, damages, fees or expenses arising out of any Third Party claim relating
to (i) any material breach by ImmunoGen of any of its representations,
warranties or obligations pursuant to this Agreement, (ii) the gross negligence
or willful misconduct of ImmunoGen, (iii) any act or omission by ImmunoGen in
the performance of its activities under the Research Program or with respect to
Co-Promoted Products or Dropped Products except those Dropped Products with
respect to which Aventis has entered into a Commercialization Agreement with
ImmunoGen, or (iv) Aventis’ use of Burdened Technology or Limited Targets, or
any Burdened Technology Obligations, to the extent any of the foregoing were
not properly disclosed by ImmunoGen to Aventis pursuant to Sections 2.2.2 and
2.8.2.  In the event of any claim
against the Aventis Indemnified Parties by any Third Party, Aventis, shall
promptly notify ImmunoGen in writing of the claim and ImmunoGen shall manage
and control, at its sole expense, the defense of the claim and its
settlement.  The Aventis Indemnified
Parties shall cooperate with ImmunoGen and may, at their option and expense, be
represented in any such action or proceeding. 
ImmunoGen shall not be liable for any litigation costs or expenses
incurred by the Aventis Indemnified Parties without ImmunoGen’s prior written
authorization.  In addition, ImmunoGen
shall not be responsible for the indemnification or defense of any Aventis
Indemnified Party arising from any negligent or intentional acts by any Aventis
Indemnified Party, or the breach by Aventis of any obligation or warranty under
this Agreement, or any claims compromised or settled without its prior written
consent.


 


15.1.3     Insurance
Proceeds.  Any indemnification
hereunder shall be made net of any insurance proceeds recovered by the
Indemnified Party; provided, however, that if, following the
payment to the Indemnified Party of any amount under this Article 15, such
Indemnified Party recovers any insurance proceeds in respect of the claim for
which such indemnification payment was made, the Indemnified Party shall
promptly pay an amount equal to the amount of such proceeds (but not exceeding
the amount of such indemnification payment) to the Indemnifying Party.


 


15.2        Insurance.  Each Party shall use all commercially
reasonable efforts to maintain insurance, including product liability
insurance, with respect to its activities hereunder.


 


15.2.1     Such
insurance shall be in such amounts and subject to such deductibles as the
Parties may agree based upon standards prevailing in the industry at the time.


 


15.2.2     Either
Party may satisfy its obligations under this Section through
self-insurance to the same extent.


 


15.3        Governing Law.  This Agreement shall be governed and the
respective rights of the Parties determined according to the substantive laws
of the State of Delaware without giving


 


68

















 


effect to any
choice of law principles that would require the application of the laws of a
different state.  Notwithstanding the
foregoing, any dispute, controversy or claim relating to the scope, validity,
enforceability or infringement of any Patent Rights or other intellectual
property rights shall be submitted to a court of competent jurisdiction in the
territory in which such Patent Rights or other intellectual property rights
were granted or arose.


 


15.4        Assignment.  Neither ImmunoGen nor Aventis may assign
this Agreement in whole or in part without the consent of the other, except
(subject in the case of ImmunoGen to Section 15.6) if such assignment
occurs in connection with the sale or transfer (by merger or otherwise) of all
or substantially all of the business and assets of ImmunoGen or Aventis to
which the subject matter of this Agreement pertains, provided that the
acquirer confirms to the other Party in writing its agreement to be bound by
all of the terms and conditions of this Agreement.  Notwithstanding the foregoing, either Party may assign this
Agreement to an Affiliate, provided that such Party shall guarantee the
performance of such Affiliate.


 


15.5        Amendments.  This Agreement and the Exhibits and
Schedules referred to in this Agreement constitute the entire agreement between
the Parties with respect to the subject matter hereof, and supersede all
previous arrangements with respect to the subject matter hereof, whether
written or oral.  The Parties
acknowledge that the Exhibits and Schedules referred to in this Agreement are being
simultaneously delivered by the Parties on or before the Effective Date.  Any amendment or modification to this
Agreement shall be made in writing signed by both Parties.


 


15.6        ***** of ***** of *****.  If ***** into or ***** to *****
into a ***** which will ***** in a ***** of ***** during the ***** of this
Agreement, ***** shall notify ***** of such ***** and the ***** of the ***** to
such ***** and such notice may be given at any time ***** to ***** into, or
***** the ***** of, such *****.  Within *****
(*****) ***** of such notice, ***** may, at its *****, ***** to ***** in the
***** (including ***** with respect thereto) and/or ***** any then ***** and
***** of ***** pursuant to Section ***** by written notice to *****.  If ***** to ***** in the *****, the *****
pursuant to Sections ***** and ***** shall *****.  If ***** to ***** the *****, the ***** pursuant to
Section ***** shall *****.  If
***** does not ***** its ***** to ***** in the ***** and/or such ***** and
***** pursuant to this Section *****, ***** shall have no ***** under this
Section 15.6 with respect to the ***** in such *****, provided that
such ***** is ***** or ***** to the ***** of the ***** of ***** to *****
hereunder.


 


15.7        Notices.  Notices to ImmunoGen shall be addressed to:


 


	
  ImmunoGen, Inc.

  
	
  128 Sidney Street

  
	
  Cambridge, Massachusetts 02139

  
	
  Attention:  Chief Executive
  Officer

  
	
  Facsimile No.:  (617) 995-2510

  



 


69

















 


	
  with a copy to:

  
	
   

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

  
	
  One Financial Center

  
	
  Boston, Massachusetts 02111

  
	
  Attention:  *****

  
	
  Facsimile No.:  (*****) *****

  
	
   

  
	
  Notices to Aventis shall be addressed to:

  
	
   

  
	
  Aventis Pharmaceuticals Inc.

  
	
  Vice President, Legal Corporate Development

  
	
  200 Crossing Boulevard

  
	
  Bridgewater, New Jersey 
  08807-0890

  
	
  Attention:  *****

  
	
  Facsimile No.:  (*****) *****

  
	
   

  
	
  with a copy to:

  
	
   

  
	
  Morgan, Lewis & Bockius, LLP

  
	
  502 Carnegie Center

  
	
  Princeton, New Jersey  08540

  
	
  Attention:  *****

  
	
  Facsimile No.:  (*****) *****

  



 


Either Party may change its address to which notices shall be sent by
giving notice to the other Party in the manner herein provided.  Any notice required or provided for by the
terms of this Agreement shall be in writing and shall be (a) sent by registered
or certified mail, return receipt requested, postage prepaid, (b) sent via a
reputable overnight courier service, or (c) sent by facsimile transmission, in
each case properly addressed in accordance with the paragraph above.  The effective date of notice shall be the
actual date of receipt by the Party receiving the same.


 


15.8        Force Majeure.  No failure or omission by either Party in
the performance of any obligation of this Agreement shall be deemed a breach of
this Agreement or create any liability if the same shall arise from any cause
or causes beyond the control of such Party, including, but not limited to, the
following:  acts of gods; acts or
omissions of any government; any rules, regulations or orders issued by any
governmental authority or by any officer, department, agency or instrumentality
thereof; fire; storm; flood; earthquake; accident; war; rebellion;
insurrection; riot; terrorist attack and invasion; provided that such
failure or omission resulting from one of the above causes is cured as soon as
is practicable after the occurrence of one or more of the above mentioned
causes.


 


70

















 


15.9        Compliance with Export Regulations.  Neither Party shall export any technology
licensed to it by the other Party under this Agreement except in compliance
with U.S. export laws and regulations.


 


15.10      Public Announcements.  On the
Effective Date, the Parties shall issue one or more press releases in the form
attached hereto as Exhibit B, the timing of which shall be mutually agreed.  Any announcements or similar publicity with
respect to the execution of this Agreement shall be agreed upon between the
Parties in advance of such announcement. 
The Parties agree that any such announcement will not contain
confidential business or technical information and, if disclosure of
confidential business or technical information is required by law or
regulation, will make commercially reasonable efforts to minimize such
disclosure and obtain confidential treatment for any such information which is
disclosed to a governmental agency or group. 
Each Party agrees to provide to the other Party a copy of any public
announcement as soon as reasonably practicable under the circumstances prior to
its scheduled release.  Except under
extraordinary circumstances, each Party shall provide the other with an advance
copy of any press release at least five (5) Business Days prior to the
scheduled disclosure.  Each Party shall
have the right to expeditiously review and recommend changes to any
announcement regarding this Agreement or the subject matter of this
Agreement.  Except as otherwise required
by law, the Party whose press release has been reviewed shall remove any
information the reviewing Party reasonably deems to be inappropriate for
disclosure.  The contents of any such
announcement or similar publicity which has been reviewed and approved by the
reviewing Party can be re-released by either Party without a requirement for
re-approval.  Furthermore, each Party
shall give the other Party a reasonable opportunity to review all filings with
the United States Securities and Exchange Commission describing the terms of
this Agreement prior to submission of such filings, and shall give due
consideration to any reasonable comments by the non-filing Party relating to
such filing, including without limitation the provisions of this Agreement for
which confidential treatment should be sought.


 


15.11      Independent Contractors.  It is understood and agreed that the relationship between the
Parties is that of independent contractors and that nothing in this Agreement
shall be construed as authorization for either ImmunoGen or Aventis to act as
agent for the other.  Members of the
Joint Steering Committee, the Joint Research Committee, the Joint Development
Committee, the U.S. Commercialization Team and any subcommittees thereof shall
be, and shall remain, employees of ImmunoGen or Aventis, as the case may
be.  No Party shall incur any liability
for any act or failure to act by members of the Joint Steering Committee, the
Joint Research Committee, the Joint Development Committee, the U.S.
Commercialization Team and any subcommittees thereof who are employees of the
other Party.


 


15.12      No Strict Construction. 
This Agreement has been prepared jointly and shall not be strictly
construed against either Party.


 


15.13      Headings.  The captions or headings of the sections or
other subdivisions hereof are inserted only as a matter of convenience or for
reference and shall have no effect on the meaning of the provisions hereof.


 


71

















 


15.14      No Implied Waivers; Rights Cumulative.  No failure on the part of ImmunoGen or
Aventis to exercise, and no delay in exercising, any right, power, remedy or
privilege under this Agreement, or provided by statute or at law or in equity
or otherwise, shall impair, prejudice or constitute a waiver of any such right,
power, remedy or privilege or be construed as a waiver of any breach of this
Agreement or as an acquiescence therein, nor shall any single or partial
exercise of any such right, power, remedy or privilege preclude any other or
further exercise thereof or the exercise of any other right, power, remedy or
privilege.


 


15.15      Severability.  If any provision hereof is held invalid,
illegal or unenforceable in any respect in any jurisdiction, the Parties shall
substitute, by mutual consent, valid provisions for such invalid, illegal or
unenforceable provisions which valid provisions in their economic effect are
sufficiently similar to the invalid, illegal or unenforceable provisions that
it can be reasonably assumed that the Parties would have entered into this
Agreement with such valid provisions. 
In case such valid provisions cannot be agreed upon, the invalid,
illegal or unenforceable of one or several provisions of this Agreement shall
not affect the validity of this Agreement as a whole, unless the invalid,
illegal or unenforceable provisions are of such essential importance to this
Agreement that it is to be reasonably assumed that the Parties would not have
entered into this Agreement without the invalid, illegal or unenforceable
provisions.


 


15.16      Execution in Counterparts.  This Agreement may be executed in counterparts, each of which
counterparts, when so executed and delivered, shall be deemed to be an
original, and all of which counterparts, taken together, shall constitute one
and the same instrument.


 


15.17      No Third Party Beneficiaries.  No person or entity other than Aventis, ImmunoGen and their
respective Affiliates and permitted assignees hereunder shall be deemed an
intended beneficiary hereunder or have any right to enforce any obligation of
this Agreement.


 


15.18      No Consequential Damages.  NEITHER PARTY HERETO WILL BE LIABLE FOR SPECIAL, INCIDENTAL OR
CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS
RIGHTS HEREUNDER, INCLUDING WITHOUT LIMITATION LOST PROFITS ARISING FROM OR
RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH
DAMAGES.  NOTHING IN THIS
SECTION 15.18 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS
OR OBLIGATIONS OF EITHER PARTY WITH RESPECT TO THIRD PARTY CLAIMS.


 


 


[Signature
Page Follows]


 


72

















 


IN WITNESS
WHEREOF, the Parties have executed this Agreement as of the Effective Date.


 


 


	
   

  	
  IMMUNOGEN, INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
  Mitchel Sayare, Ph.D.

  
	
   

  	
   

  	
  President and Chief Executive Officer

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  AVENTIS PHARMACEUTICALS INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  Frank L. Douglas, M.D.

  
	
   

  	
   

  	
   

  	
  Executive Vice President

  
	
   

  	
   

  	
   

  	
  Drug Innovation & Approval

  Aventis Authorized Signatory

  
					



 


73

















 


EXHIBIT A


 


ANNUAL
RESEARCH PLAN


 


 

















 


Exhibit B


 


PRESS RELEASE


 


 


[See
Attached]


 


B-1

















 


	
   

  	
  

  



 


	
  Corinne Hoff

  	
   

  	
  Kara Smith

  
	
  Aventis Global Media Relations

  	
   

  	
  DI&A Communications

  
	
  Tel.: +33 (0)3 88 99 19 16

  	
   

  	
  Tel.: +1 908 231 4490

  
	
  Corinne.Hoff@Aventis.com

  	
   

  	
  Kara.Smith@Aventis.com

  



 


 


Aventis and ImmunoGen Sign Collaboration
Agreement

to Discover, Develop, and Commercialize Novel Anti-cancer Therapeutics


 


Collaboration Pairs Aventis’ Strength in the
Global Development and Commercialization of Novel Anti-cancer Products
with ImmunoGen’s Antibody Expertise


 


Strasbourg, France, July 31, 2003
–  Aventis and ImmunoGen announced today
the signing of a collaboration agreement to discover, develop, and
commercialize novel antibody-based anti-cancer products.  The agreement combines the strength of
Aventis in oncology product development and commercialization with ImmunoGen’s
antibody expertise.


 


Aventis will
acquire the worldwide commercialization rights to the new product candidates
created by the collaboration as well as worldwide commercialization rights to
three early-stage product candidates in ImmunoGen’s research pipeline: a
potential new treatment for the blood cancer, acute myeloid leukemia; a
potential new treatment for a number of solid tumors, including breast, lung
and prostate cancers; and a potential new treatment for certain B-cell blood
cancers including non-Hodgkin’s lymphoma.


 


Aventis and
ImmunoGen will collaborate to create antibody-based anti-cancer products using
targets provided by both companies. 
Aventis is responsible for product development, manufacturing, and
commercialization, and will cover all associated costs.  ImmunoGen has an option to certain
co-promotion rights in the United States on a product-by-product basis.


 


“Fully in line with our strategy to reinforce our leadership position
in oncology, this alliance provides Aventis with a foothold in the expanding
field of monoclonal antibodies. 
ImmunoGen’s antibody expertise, including their immunoconjugate
technology, is highly complementary to our established oncology expertise.  We are very pleased to work with ImmunoGen
to develop additional potential treatments to combat cancer,” said Frank L.
Douglas, Executive Vice President of Drug Innovation & Approval and a
member of the Management Board of Aventis.


 


B-2

















 


Mitchel
Sayare, Ph.D., ImmunoGen Chairman and CEO, commented, “We are delighted to
enter into a collaboration with Aventis, a leading pharmaceutical company and a
global powerhouse in oncology.  This
partnership is an important milestone for ImmunoGen – it enables us to develop
more products, faster, and at lower cost, than would be possible on our own and
it provides us with a global commercialization partner for the collaboration
products.  We now are able to expand our
efforts in the development of naked antibody therapeutics, enhance our effector
molecule program for Tumor-Activated Prodrug (TAP) immunoconjugate products,
and significantly increase our product development programs overall.”


 


Under the
terms of the agreement, ImmunoGen will receive an upfront payment of $12
million and more than $50 million in committed research funding over a
three-year period.  Aventis has an
option to extend the research collaboration for one to two years.  An extension of the collaboration could
bring the total committed funding to ImmunoGen up to $99 million.  Additionally, for each product candidate,
ImmunoGen can receive milestone payments of between $20 million and $30 million
based on development and regulatory achievements as well as royalties on
commercial sales.  Aventis is responsible
for and pays for the manufacturing of clinical and commercial materials.  Additional financial terms were not
disclosed.


 


Aventis is a world leader in oncology. 
Its oncology product portfolio includes TaxotereÒ,
one of the most widely used chemotherapeutics in the world.  In 2002, Taxotere sales worldwide exceeded
€1 billion.


 


In addition to Taxotere, Aventis markets CamptoÒ (irinotecan),
a reference treatment for advanced colorectal cancer, in countries other than
Japan and North America, and AnzemetÒ (dolasetron
mesylate), a 5HT3 inhibitor for the treatment of chemotherapy induced nausea
and vomiting that is marketed in North America.


 


Aventis also
has a rich pipeline of investigational oncology compounds, including AVE-8062,
a unique antivascular agent; flavopiridol, a novel cell cycle inhibitor; new
taxoids, that may offer benefits over available taxanes; and the ALVAC cancer
vaccines being developed through the vaccines business of Aventis.


 


In 2002,
Aventis entered a global agreement with Genta Inc. to jointly develop and
commercialize GenasenseÔ,
an antisense compound designed to decrease the synthesis of Bcl-2, a protein
which prevents apoptosis.  Genasense,
currently in late-stage development, may enhance the effectiveness of current
anti-cancer treatments.


 


ImmunoGen has
comprehensive capabilities in the creation of antibody-based anti-cancer
therapeutics, including expertise and intellectual property related to the
identification and validation of biological targets for cancer treatments, the
development and humanization of monoclonal antibodies, and the creation of
potent cell-killing agents designed for antibody delivery to cancer cells.  ImmunoGen’s proprietary Tumor-Activated
Prodrug (TAP) technology provides the company with the flexibility to develop a
product candidate as either an


 


B-3

















 


immunoconjugate
(products that use the antibody to deliver a potent cell-killing agent to the
cancer cell) or as a naked antibody (products in which the antibody alone
inhibits or kills the cancer cell) depending on the target.


 


About Aventis


Aventis is dedicated to treating and preventing disease by discovering
and developing innovative prescription drugs and human vaccines.  In 2002, Aventis generated sales of € 17.6
billion, invested € 3.1 billion in research and development and employed
approximately 71,000 people in its core business.  Aventis corporate headquarters are in Strasbourg, France.  For more information, please visit:
www.aventis.com


 


About ImmunoGen, Inc.


ImmunoGen, Inc. develops targeted anti-cancer therapeutics.  The Company has extensive expertise and
intellectual property related to identification of biological targets for
cancer treatments, development and humanization of monoclonal antibodies, and
creation of potent cell-killing agents designed for antibody delivery to cancer
cells.  The Company’s TAP technology
uses tumor-targeting antibodies to deliver a highly potent, cell-killing agent
specifically to cancer cells.  Two
ImmunoGen-developed TAP products have begun clinical evaluation: cantuzumab
mertansine and huN901-DM1/BB-10901; the latter is licensed to British Biotech
in certain territories.  Several
companies are developing products using TAP technology licensed from ImmunoGen:
Millennium Pharmaceuticals (MLN2704), Boehringer Ingelheim (bivatuzumab
mertansine), and Genentech (Trastuzumab-DM1). 
For more information, visit ImmunoGen’s website at www.ImmunoGen.com.


 


Statements in this
news release other than historical information are forward-looking statement
subject to risks and uncertainties. 
Actual results could differ materially depending on factors such as the
availability of resources, the timing and effects of regulatory actions, the
strength of competition, the outcome of litigation and the effectiveness of
patent protection.  Additional
information regarding risks and uncertainties is set forth in the current
Annual Report on Form 20-F of Aventis on file with the Securities and Exchange
Commission.


 


ImmunoGen Contacts:


 


	
  Carol Hausner (Investors)

  	
   

  	
  Peter Holmberg (Media)

  
	
  Senior Director, Investor Relations and

  Corporate Communications

  	
   

  	
  Rx Communications Group, LLC

  
	
  Tel: +1 617 995 2500

  	
   

  	
  Tel: +1 917 322 2164

  
	
  info@ImmunoGen.com

  	
   

  	
  pholmberg@rxir.com

  



 


B-4

















 


Schedule 1.8


 


Approved Subcontractors


 


Related to Production
of GMP Grade Materials


 


	
  Subcontractor

  	
   

  	
  Address

  	
   

  	
  Service
  Provided

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  



 


 


Research


 


	
  Subcontractor

  	
   

  	
  Address

  	
   

  	
  Service
  Provided

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  



 


S-1

















 


Schedule 1.50


 


ImmunoGen Patent Rights


 


 


*****


(***** comprising ***** and their *****)


 


	
  Atty. Ref.

  No.

  	
   

  	
  Country

  	
   

  	
  Appl.

  No.

  	
   

  	
  Filing

  Date

  	
   

  	
  Priority

  Date

  	
   

  	
  Patent

  No.

  	
   

  	
  Issue Date

  	
   

  	
  Expiry

  Date

  	
   

  	
  Next

  Due

  	
   

  	
  Entity

  	
   

  	
  Assignee

  	
   

  	
  Agent

  	
   

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
   

  	
   

  	
  *****

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  *****

  	
   

  
	
  *****

  	
   

  	
  *****

  	
   

  	
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  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
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  *****

  	
   

  	
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  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
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  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  
	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
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  *****

  	
   

  	
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  *****

  	
   

  	
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  *****

  	
   

  	
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  *****

  	
   

  	
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  *****

  	
   

  	
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***** (“*****”)


(***** of ***** using *****)


 


	
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*****


(*****
for the ***** and ***** of *****)


 


	
  Atty. Ref.

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S-2

















 


*****


(***** for the ***** of ***** of ***** and *****)


 


	
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*****


(*****
with *****)


 


	
  Atty. Ref.

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  Due

  	
   

  	
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  *****

  	
   

  	
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*****
FOR THE ***** OF *****


 


	
  Atty. Ref.

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  Due

  	
   

  	
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  *****

  	
   

  	
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*****
COMPRISING *****


 


	
  Atty. Ref.

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*****
(*****)


 


	
  Atty. Ref.

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*****


(***** of ***** and ***** of *****; *****)


 


	
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*****


(***** for the ***** of ***** of ***** and
*****)


 


	
  Atty. Ref.

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***** OF *****


(***** for the ***** of ***** of ***** and
*****)


 


	
  Atty. Ref.

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  Due

  	
   

  	
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*****


(*****
of *****)


 


	
  Atty. Ref.

  No.

  	
   

  	
  Country

  	
   

  	
  Appl.

  No.

  	
   

  	
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  No.

  	
   

  	
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  Date

  	
   

  	
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  Entity

  	
   

  	
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S-3

















 


	
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*****


(***** and ***** for ***** using ***** and
*****)


 


	
  Atty. Ref.

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*****


(***** comprising ***** and their *****)


 


	
  Atty. Ref.

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(***** comprising ***** and their *****)


(***** with *****)


 


	
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(*****
to ***** and *****, and ***** thereof)


 


	
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(***** and ***** for ***** of  ***** using the *****)


 


	
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(*****
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S-4

















 


*****


(***** and ***** of using the *****)


 


	
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*****


(*****
and ***** of using the *****)


 


	
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  No.

  	
   

  	
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S-5

















 


Schedule 1.59


 


*****
of *****


 


 


*****


 


*****


 


*****


 


*****


 


*****


 


S-6

















 


Schedule 1.61


 


Description
of ***** Antibody


 


 


*****; *****


 


 


*****


 


*****


 


*****


 


*****


 


*****


 


S-7

















 


Schedule 1.62


 


*****
Targets


 


 


S-8

















 


Schedule 14.6.2


 


Patent
*****


 


S-9