Development and License Agreement

between

 

ImmunoGen, Inc.

128 Sidney Street

Cambridge, MA  02139

U.S.A.

(hereinafter called “ImmunoGen”)

 

and

 

Boehringer Ingelheim International GmbH

Binger Strasse 173

55218 Ingelheim am Rhein

GERMANY

(hereinafter called “BI”)

 

having an Effective Date of November 27, 2001 (the “Effective Date”).

 

WITNESSETH:

 

WHEREAS, BI is a pharmaceutical company engaged in the research, development,
manufacture and commercialisation of pharmaceutical products and Controls
certain patents and know-how related to the humanised monoclonal antibody BIWA4;
and

 

WHEREAS, ImmunoGen Controls certain patents, and know-how related to ImmunoGen’s
maytansinoid DM1 technology, and it has the right to grant certain rights and
licenses thereunder as set forth herein; and

 

WHEREAS, BI desires to obtain a license from ImmunoGen to develop, manufacture,
market and sell the Licensed Products in the Territory, and ImmunoGen desires to
grant such a license to BI, on the terms and conditions contained in this
Agreement.

 

NOW THEREFORE, in consideration of the covenants and promises in this Agreement,
ImmunoGen and BI agree as follows:

 

1

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

 

Table of Contents

 

1.

DEFINITIONS

2.

GRANT OF RIGHTS AND RESTRICTIONS

3.

PAYMENTS, REPORTS AND RECORDS

4.

DEVELOPMENT AND COMMERCIALISATION

5.

SUPPLY AND MANUFACTURING OBLIGATIONS

6.

PRODUCT INQUIRIES, COMPLAINTS AND ADVERSE EVENTS

7.

RIGHTS AND IMPROVEMENTS

8.

PATENTS AND TRADEMARKS

9.

INFRINGEMENT

10.

REPRESENTATIONS AND WARRANTIES

11.

INDEMNIFICATION

12.

CONFIDENTIALITY

13.

TERM AND TERMINATION

14.

EFFECTS OF TERMINATION

15.

MISCELLANEOUS

16.

SCHEDULES

 

2

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

 

1.

DEFINITIONS

 

 

 

 

1.1

“Adverse Event”

shall mean any untoward medical occurrence in a patient or subject who is
administered a Licensed Product, whether or not considered related to the
Licensed Product, including, without limitation, any undesirable sign (including
abnormal laboratory findings of clinical concern), symptom or disease temporally
associated with the use of such Licensed Product.

 

 

 

1.2

“Affiliates”

shall mean any company or business entity which controls, is controlled by, or
is under common control with, either ImmunoGen or BI.  For purposes of this
definition, “control” shall mean the possession, directly or indirectly or the
power to direct or cause the direction of the management and policies of an
entity (other than a natural person), whether through the majority ownership of
voting capital stock, by contract or otherwise.

 

 

 

1.3

“BI Materials”

shall mean any tangible chemical, biological or research materials, including
without limitation, any assays or antibodies, whether or not patentable, used by
BI or furnished by BI to ImmunoGen under this Agreement.  BI Materials shall
include, without limitation, the BIWA4 antibody.

 

1.4

“BI Intellectual Property”

shall mean any Technology and Patent Rights Controlled by BI during the Term
that are used by BI or provided by BI for use in the activities contemplated by
this Agreement.  BI Intellectual Property Patent Rights as of the Effective Date
are described on Schedule C.

 

 

 

1.5

“BIWI1”

shall mean any conjugate of “naked” BIWA4 with DM1.

 

 

 

1.6

“Commercially Reasonable Efforts”

shall mean the efforts and resources that BI would use for a compound owned by
it or to which is has rights, which is of similar market potential at a similar
stage in development as the applicable Licensed Product, taking into account the
competitiveness of the marketplace, the proprietary position of the Licensed
Product, the profitability and the relative potential safety and efficacy of the
Licensed Product, and other relevant factors including, without, limitation,
technical, legal, scientific or medical factors.

 

 

 

1.7

“Comparable Product”

shall mean any [ * ] that has the same [ * ] as a Licensed Product.

 

 

 

1.8

“Competent Authorities”

shall mean the United States Food and Drug Administration (FDA), the European
Commission and any foreign health authority charged with responsibility for
regulating the approval to market a Licensed Product for the treatment of
humans.

 

3

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

 

1.9

“Control”

shall mean, with respect to tangible or intangible property, including
intellectual property or other matters, title to such property and/or possession
of the ability to grant a license or sublicense to such property without
violating any agreement with a third party.

 

 

 

1.10

“[ * ] ”

shall mean with respect to any Drug Substance or Drug Product, the  [ * ] of
producing (including the  [ * ] of such Drug Substance and Drug Product,
including the sum of the following components: (a) the  [ * ] , including[ *
]and [ * ], of [ * ] and [ * ] such BIWI1; (b) all [ * ] incurred by ImmunoGen
attributable to the [ * ] under the foregoing clause (a), including, without
limitation, [ * ] and [ * ] which are [ * ] to [ * ] or another [ * ]; (c) any
other [ * ] borne by ImmunoGen for the [ * ] and/or [ * ] of such Drug Substance
and Drug Product; and (d) [ * ] and [ * ] which are [ * ] to [ * ] or another [
* ] .  Notwithstanding the foregoing, [ * ] of Drug Substance shall not include
the [ * ] of [ * ] any [ * ] to the [ * ] by BI pursuant to Section [ * ]  of
this Agreement.

 

 

 

1.11

“DM1”

shall mean that certain maytansine derivative known as “DM1” whose specific
chemical name is N2’-deacetyl-N2’(3-mercapto-1-oxopropyl)-maytansine.

 

 

 

1.12

“Drug Product”

shall mean Drug Substance, manufactured under cGMP in the final concentration
for clinical use, aseptically filled in unlabeled, primary packaging material.

 

 

 

1.13

“Drug Substance”

shall mean bulk BIWI1.

 

 

 

1.14

“Effective Date”

shall mean the date first mentioned above.

 

 

 

1.15

“Field”

shall mean [ * ].

 

 

 

1.16

“First Commercial Sale”

shall mean the date of the first commercial sale (other than for purposes of
obtaining regulatory approval) of a Licensed Product by or on behalf of BI or
any Sublicensee of BI.

 

 

 

1.17

“ImmunoGen Materials”

shall mean any tangible chemical, biological or research materials, including
without limitation, DM1, or any assays or antibodies other than BI Materials,
whether or not patentable, used by ImmunoGen or furnished by ImmunoGen to BI
under this Agreement.

 

4

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

 

1.18

“Improvement(s)”

shall mean any enhancement, improvement or modification to the Licensed
Technology or covered by the Licensed Patent Rights which is conceived, reduced
to practice or discovered during the Term of this Agreement.

 

 

 

1.19

“Indication”

shall mean [ * ], e.g. [ * ] or mean and [ * ].

 

 

 

1.20

“Initiation”

shall mean, with respect to any clinical study, the [ * ] for such clinical
study by or on behalf of BI.

 

 

 

1.21

“IND”

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

 

 

 

1.22

“Licensed Product(s)”

shall mean any product containing a conjugate of DM1 with an antibody or
antibody derivative that is specific for the Target Antigen, including, without
limitation, BIWI1, and any drug product containing such conjugate.  For purposes
of clarity, the Parties hereby acknowledge and agree that a given Licensed
Product that has one or more Indications shall not be considered to be a
Subsequent Licensed Product for purposes of Section 3.3(d) of this Agreement.

 

 

 

1.23

“Licensed Technology”

shall mean (i) the Technology described on Schedule A attached hereto; and (ii)
any Improvements thereto (other than Improvements that are Patent Rights)
Controlled by ImmunoGen during the Term of the Agreement [ * ] to the extent [ *
] in accordance with Section 2.3 hereof, [ * ] to the extent that any of the
foregoing relates to any Licensed Patent Rights or is necessary or useful to
develop, have developed, make, have made, sell and have sold Licensed Products.

 

 

 

1.24

“Licensed Patent Rights”

shall mean the Patent Rights in the Field in the Territory Controlled by
ImmunoGen during the Term which block, absent a license, the use, making or
selling of a Licensed Product. Licensed Patent Rights as of the Effective Date
are described on Schedule [ * ]  attached thereto.

 

 

 

1.25

“Major Markets”

shall mean the [ * ] and the [ * ] .

 

 

 

 

5

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

 

1.26

“Net Sales”

shall mean, as to each [ * ] during the [ * ], the [ * ] for all [ * ] sold by
BI and its Sublicensees to third parties throughout the [ * ]  during such [ *
], less the [ * ] or [ * ] by BI or its Sublicensees during such [ * ] with
respect to [ * ] of [ * ] regardless of the [ * ] in which such [ * ] were made:

 

 

 

 

 

(a)

[ * ]and [ * ] or [ * ] actually taken and allowed, including [ * ] or [ * ] to
[ * ] or [ * ] ;

 

 

 

 

 

 

(b)

[ * ]]or [ * ] given or made for [ * ] or [ * ] of [ * ] or for [ * ] (including
[ * ] and similar types of [ * ]);

 

 

 

 

 

 

(c)

any [ * ] for [ * ]and other [ * ] directly related to the [ * ] of [ * ] to the
extent included in the[ * ];

 

 

 

 

 

 

(d)

any [ * ] or [ * ] levied on the [ * ] or [ * ] of a [ * ]] (including any [ * ]
such as a [ * ] or [ * ] or [ * ]) borne by the seller thereof, other than [ *
]or of any kind whatsoever; and

 

 

 

 

 

 

(e)

any [ * ] or [ * ] or their equivalent borne by the seller.

 

 

 

1.27

“Patent Rights”

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

 

 

 

1.28

“Phase I Trial”

shall mean any clinical study involving the use of the Licensed Product in
humans that is designed primarily to obtain preliminary safety data on the use
of a Licensed Product in human patients.

 

 

 

1.29

“Phase IIa Trial”

shall mean any controlled clinical study involving the use of the Licensed
Product in human patients that is designed primarily to obtain preliminary data
on the effectiveness of a specific therapy involving the use of a Licensed
Product in human patients.  Phase IIa Trials must take place after Phase I
Trials.

 

 

 

1.30

“Pivotal Trial”

shall mean any Phase IIb/III clinical study involving a Licensed Product and
having adequate statistical power to meet the requirements for regulatory
approval by the FDA or the European Commission.

 

 

 

1.31

“Recognised Agents”

shall mean any third party legal entity (other than an Affiliate of BI) engaged
by BI in the normal course of its business to market and/or distribute its
products in a particular country of the Territory.

 

6

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

 

1.32

“Sublicensee”

shall mean any person, corporation, unincorporated body, or other entity
including Affiliates of BI to whom BI grants a sublicense of the rights granted
to BI pursuant to this Agreement. For the avoidance of doubt, Recognised Agents
shall not be considered to be Sublicensees for the purposes of this Agreement.

 

 

 

1.33

“Target Antigen”

shall mean either [ * ] and its [ * ] or, in case Section [ * ]  applies, [ * ]

 

 

 

1.34

“Technology”

shall mean and include any and all unpatented proprietary ideas, inventions,
discoveries, data, results, formulae, designs, specifications, methods,
processes, formulations, techniques, ideas, know-how, technical information
(including, without limitation, structural and functional information), process
information, and any and all proprietary biological, chemical, pharmacological,
toxicological, pharmacokinetic, chemical, analytical, pharmaceutical, and
clinical data.

 

 

 

1.35

“Territory”

shall mean the world.

 

 

 

1.36

“Valid Claim”

shall mean a claim in an issued, unexpired patent within the Licensed Patent
Rights that (i) has not been finally cancelled, withdrawn, abandoned or rejected
by any administrative agency or other body of competent jurisdiction and (ii)
has not been revoked, held invalid, or declared unpatentable or unenforceable in
a decision of a court or other body of competent jurisdiction that is
unappealable or unappealed within the time allowed for appeal.

 

2.             GRANT OF RIGHTS AND RESTRICTIONS

 

2.1           Grant of License to BI:

 

Subject to the terms and conditions of this Agreement, ImmunoGen grants to BI,
and BI accepts, an exclusive, royalty-bearing license, including the right to
grant sublicenses as described below, within the Field and in the Territory,
under the Licensed Technology and the Licensed Patent Rights and ImmunoGen’s
interest in any Improvements Controlled by ImmunoGen to the extent accepted in
accordance with Section 2.3 hereof, to develop, make, use and sell Licensed
Products.

 

2.2           ImmunoGen Retained Rights:

 

Subject to the other terms of this Agreement, ImmunoGen retains the right to use
the Licensed Technology and practice the Licensed Patent Rights and to use
ImmunoGen’s interest in all Improvements (i) to perform its work under this
Agreement (ii) to develop, have developed, make, have made, use, have used, sell
have sold, offer for sale, import, have imported, export and have exported any
product that is not a Licensed Product and (iii) for any and all uses outside of
the Field.

 

7

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

 

2.3           Additional Rights:

 

(a)                                  ImmunoGen herewith grants to BI [ * ]
during the Term regarding all Improvements (including its interest in any
Improvements owned jointly by ImmunoGen and BI) Controlled by ImmunoGen or its
Affiliates during the Term to the extent such Improvements relate to any
Licensed Patent Rights or are necessary or useful to develop, have developed,
make, have made, sell and have sold Licensed Products. If BI [ * ] ImmunoGen [ *
] of its [ * ] in the respective Improvement at any time during the Term, BI
shall [ * ] an [ * ] so long as such Improvement is Controlled by ImmunoGen at
the [ * ] of such[ * ], consistent with the terms of[ * ], which [ * ]such
Improvement to the [ * ] of the Licensed Patent Rights and/or Licensed
Technology, as the case may be, [ * ] any [ * ] from BI to ImmunoGen.

 

(b)                                 BI hereby grants to ImmunoGen a
non-exclusive, royalty-free license under BI Intellectual Property and BI’s
interest in any Improvements to manufacture the Drug Substance and Drug Product
solely for delivery to BI, its Affiliates, Recognised Agents and Sublicensees
for the limited duration and purposes as set forth in Section 5 below and
subject to the terms of this Agreement and the Clinical Supply Agreement
attached as Schedule G.

 

2.4           Right to Sublicense/Sub-contract and Partner; Right to License BI
Improvements:

 

(a)                                  BI shall have the right to grant
sublicenses of its rights granted under Section 2.1 hereof to its Affiliates and
other Sublicensees.

 

(b)                                 BI agrees to contractually bind its
Sublicensees by terms and obligations substantially similar to those applying to
BI hereunder, including without limitation, BI's confidentiality and royalty
obligations.

 

(c)                                  BI shall have the right to partner with
third parties to co-market and/or co-promote the Licensed Products in all
countries of the Territory.

 

(d)                                 Notwithstanding anything herein to the
contrary, BI shall be responsible for all obligations herein to be performed by
it and any Sublicensee or partner.  BI shall also be responsible for any and all
breaches of any obligations hereunder by any Sublicensee, Recognised Agent,
partner and other subcontractor of BI.

 

(e)                                  BI shall not license its interest in any
Improvements to any third party, other than in connection with the grant of a
sublicense to a Licensed Product or any license or sublicense to any other
product containing DM1 Controlled by BI.  Subject to the foregoing, BI shall be
free to use its interest in any Improvements for all purposes, including,
without limitation, the sale of DM1 and DM1 intermediates to third parties.

 

8

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

 

3.             PAYMENTS, REPORTS AND RECORDS

 

3.1           Upfront-fee:

 

In consideration of the rights granted by ImmunoGen to BI hereunder, BI will pay
ImmunoGen the non-refundable, non-creditable sum of [ * ] to an account
designated by ImmunoGen within [ * ] business days following the Effective Date.

 

3.2           Milestone Payments:

 

(a)                                  In further consideration of the rights
granted by ImmunoGen to BI hereunder, including the licenses set forth in
Section 2 above, BI will pay ImmunoGen non-refundable, non-creditable milestone
payments as follows:

 

(i)            [ * ]:                                                   Payment

  Upon [ * ]of an [ * ]in the [ * ]for a[ * ].

[ * ]

 

(ii)           [ * ]:                                                   Payment

Upon[ * ] of the [ * ] for a.

[ * ]

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

[ * ]

Upon [ * ] of the [ * ] for a[ * ].

[ * ]

Upon [ * ]of the [ * ] in the [ * ] for a[ * ]

[ * ]

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

[ * ]

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

[ * ]

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

[ * ]

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

[ * ]

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

[ * ]

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

[ * ]

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

[ * ]

 

(iii)          [ * ]:

 

A [ * ]of :

·      [ * ]

·      [ * ]

·      [ * ]

·      [ * ]

 

(b)                                 BI shall pay ImmunoGen the [ * ] set forth
in Section [ * ]  and [ * ]  within [ * ] of the occurrence of the respective [
* ] and the [ * ] pursuant to Section [ * ]  within [ * ] of the [ * ] of the[ *
]. The [ * ] pursuant to Section [ * ]  and the [ * ] pursuant to Section [ * ] 
and [ * ]shall be [ * ] in[ * ]. The [ * ] pursuant to Section [ * ]  shall be [
* ] in[ * ].

 

9

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

 

(c)                                  It is hereby understood that each [ * ]
shall be [ * ] for the [ * ] of a [ * ]by a [ * ] and that [ * ] shall be made
for any [ * ] of [ * ] by a[ * ].

 

3.3           Royalty Payments:

 

(a)                                  In further consideration of the rights
granted by ImmunoGen to BI hereunder, including the licenses set forth in
Section 2 above, BI will pay ImmunoGen a [ * ]on [ * ]of [ * ]by a [ * ]under a
[ * ] or [ * ] as follows:

 

[ * ]                                                        [ *
]                                                     [ * ]

[ * ]                                                        [ *
]                                                     [ * ]

[ * ]                                                        [ *
]                                                     [ * ]

[ * ]                                                        [ *
]                                                     [ * ]

[ * ]                                                              

 

**For purposes of this Section 3.3(a), “[ * ]” shall refer to the [ * ]to [ *
]to [ * ]such that the “[ * ]” shall be [ * ]if ImmunoGen [ * ] a [ * ] with
such[ * ].

 

(b)                                 The above [ * ] shall be [ * ] on a [ * ]
basis on the [ * ] of [ * ] from its [ * ] until the [ * ] of the [ * ] as
provided in Section [ * ]. The above [ * ] be [ * ] by [ * ] in [ * ] on a [ * ]
basis with respect to[ * ] if (i) the[ * ] or [ * ]of such [ * ]in such country
is [ * ]by a [ * ]in [ * ]but is [ * ]by the[ * ]; or (ii) (A) the [ * ]in [ *
]covering the [ * ]or of a [ * ], (B) [ * ]are [ * ]in such [ * ] and (C) such [
* ] have, in the [ * ] during such[ * ]or [ * ]of the [ * ] in such [ * ] in
connection with the [ * ] of such[ * ]

 

(c)                                  In the event that BI, in order to [ * ]to
it [ * ]hereunder in any[ * ], is required to [ * ] to [ * ] or [ * ] (i) to [ *
] under their [ * ] in the [ * ]of which the [ * ] of a [ * ] could not [ * ] be
[ * ] or [ * ] in such [ * ] and/or (ii) to [ * ] under their [ * ] specific to
the [ * ] used by ImmunoGen to[ * ], in the [ * ] of which any of the [ * ]
necessary to [ * ] as part of a [ * ] can not [ * ] be [ * ] ([ * ], to the[ *
], by an [ * ]of[ * ]), then [ * ]due to [ * ]for a given [ * ]may be [ * ]by [
* ]of the [ * ]of such [ * ]Notwithstanding the following, such [ * ] shall in
no event [ * ] the [ * ] for such [ * ]payable under [ * ] Section [ * ]  to
less than [ * ] of [ * ] in such[ * ]

 

10

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

 

(d)                                 BI shall pay [ * ]with respect to each [ *
]on a [ * ]and [ * ] basis as follows:

 

(1) with respect to the [ * ] by BI or any Sublicensee of BI under this
Agreement (the “[ * ] ”) until the [ * ] of the [ * ] of the [ * ] to [ * ] of
the [ * ] or [ * ] from [ * ] of [ * ] of such[ * ], and;

 

(2) with respect to any [ * ] the [ * ] of [ * ] of the [ * ](each, a “[ * ] ”);

 

(A) if BI at the [ * ] of the [ * ] is [ * ] in [ * ] with [ * ] of the [ *
]under Section [ * ]  of this Agreement, then until the [ * ] of (i) the [ * ]
of the [ * ] of the [ * ] covering the [ * ] or (ii) [ * ] from the [ * ] of [ *
] of such[ * ]; provided, that, [ * ]Section [ * ]  of this Agreement, the [ * ]
for any [ * ] covered by this Section 3.3(d)(2)(A)(ii) shall be [ * ] and;

 

(B) if BI at the [ * ] of the [ * ] is [ * ] from [ * ] of the [ * ] under
Section[ * ], then until the [ * ] of (i) the [ * ] of the [ * ] of the [ * ]
covering the [ * ] or (ii) the [ * ] on which [ * ]to [ * ]from [ * ] of any [ *
] for an [ * ] of [ * ] (whether or not such [ * ] are [ * ]).

 

3.4           Reports:

 

Each royalty payment shall be accompanied by a written report describing the Net
Sales of the Licensed Product sold by or on behalf of BI, its Affiliates and
Sublicensees during a "Payment Period" in each country in the Territory in which
such Licensed Product occurred in the [ * ] covered by such statement,
specifying: the [ * ]  and [ * ] in each country’s currency; the applicable [ *
] under this Agreement; the [ * ] in each country’s currency, including an [ * ]
of [ * ] taken in the [ * ] of[ * ]; the [ * ] to [ * ] from each [ * ] to[ * ],
under this Section 3.4; and the [ * ] in[ * ].  Payment Period means a[ * ],
commencing upon the[ * ]

 

3.5           Method and Manner of Royalty Payment:

 

(a)                                  BI shall deliver to ImmunoGen within [ * ]
following the end of each [ * ] a [ * ] as set forth in Section [ * ]  along
with BI's payment to ImmunoGen of any [ * ] and [ * ] to ImmunoGen for such[ *
].

 

(b)                                 All royalty payments shall be [ * ] and [ *
] in [ * ] at [ * ] as [ * ] by the[ * ], and as customarily used by BI in its[
* ]

 

3.6           Withholding Tax:

 

(a)                                  BI shall [ * ] any [ * ] and other [ * ]
from the [ * ] agreed upon under Sections[ * ], and [ * ]  of this Agreement and
[ * ] them to the [ * ] required by law applicable at the date of [ * ] BI shall
maintain [ * ] of [ * ] of any [ * ] and forward these [ * ] to ImmunoGen.

 

11

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

 

(b)                                 The parties will exercise their best efforts
to ensure that any [ * ] imposed are [ * ] as far as possible under the
provisions of the current or any future [ * ]between the [ * ] and the [ * ].

 

(c)                                  The parties hereby acknowledge that
according to [ * ] this [ * ] requires that the [ * ] a [ * ] of[ * ]

 

(d)                                 The parties hereby acknowledge that in order
to achieve such [ * ] ImmunoGen is required to provide [ * ] with the [ * ] for
a [ * ] of [ * ]in respect of [ * ] performed on the [ * ] containing the
statement of [ * ] and [ * ] of the [ * ] as well as the [ * ] of [ * ] a [ * ]
, in which it confirms that it does not [ * ] the [ * ] through a [ * ] in [ * ]
BI agrees to provide ImmunoGen with the [ * ]

 

(e)                                  ImmunoGen hereby acknowledges that every [
* ] ImmunoGen is required to submit a[ * ], which complies with the
above-mentioned prerequisites.

 

3.8           Records:

 

BI and/or its Sublicensees shall keep and maintain records of sales of Licensed
Product so that the royalties payable and the royalty statements may be
verified. Such records shall be open to inspection during business hours for a [
* ] period after the royalty period to which such records relate, but in any
event[ * ], by a nationally recognised independent certified public accountant
selected by ImmunoGen to whom BI has no reasonable objections and retained at
ImmunoGen's expense. Said accountant shall sign a confidentiality agreement
prepared by ImmunoGen and reasonably acceptable to BI and shall then have the
right to examine the records kept pursuant to this Agreement and report to
ImmunoGen the findings  [ * ] of said examination of records as are necessary to
evidence that the records were or were not maintained and used in accordance
with this Agreement. A copy of any report provided to ImmunoGen by the
accountant shall be given concurrently to BI. If said examination of records
reveals any [ * ]of the[ * ], then BI shall promptly pay the balance due to
ImmunoGen, and if the [ * ] is/are more than[ * ], then BI shall also bear the
expenses of said accountant. If said examination of records reveals any
overpayment(s) of royalty payable, then ImmunoGen shall credit the amount
overpaid against BI's future royalty payment(s).

 

3.9           Overdue Payments.

 

Payments not paid within the time period set forth in this Section 3 shall bear
interest at a rate of [ * ]per [ * ] from the due date until paid in full.

 

4.             DEVELOPMENT AND COMMERCIALISATION

 

4.1           Development Responsibility:

 

(a)                                  Except as otherwise set forth in this
Agreement, BI shall solely be responsible for the development of the Licensed
Product for the Field as provided hereunder, including but not limited to any
and all pre-clinical development activities, clinical studies and other testing
and work conducted in connection with the Licensed Product for the Field, at
BI's own expense and BI shall be solely responsible for making decisions related
hereto.

 

12

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

 

(b)                                 If prior to any [ * ] by BI with respect to
a given[ * ], BI determines, in its reasonable discretion, that the [ * ] of
such [ * ] using the [ * ] has[ * ], then BI shall have the right, upon not less
than [ * ] prior written notice to ImmunoGen, to[ * ] as the [ * ] without any [
* ] from BI to ImmunoGen.  Any decision regarding the [ * ] of [ * ] of a [ *
]that is [ * ] to the [ * ] is in the [ * ] of[ * ]

 

4.2           Development Obligation:

 

(a)                                  After the Effective Date, BI shall use its
[ * ] and shall accept the corresponding responsibility, at its sole cost and
expense, for the development, safety of, and all required periodic reporting to
Competent Authorities required to obtain all regulatory approvals for, the
Licensed Product(s) for the Field in the Major Market countries.

 

(b)                                 After the Effective Date, BI shall provide
to ImmunoGen regular written reports every[ * ], setting forth (i) significant
developments with respect to Licensed Product, and (ii) the status and progress
of the development and/or registration activities related to the Licensed
Product.

 

(c)                                  BI shall promptly advise ImmunoGen in
writing upon the filing for regulatory approval to market a Licensed Product,
and upon receipt of regulatory approval to market a Licensed Product, in each
case in each country of the Territory.

 

(d)                                 ImmunoGen [ * ] to [ * ] and [ * ] the [ * ]
for [ * ] to meet [ * ]for [ * ] of [ * ] , according to the [ * ] attached as
Schedule [ * ] and thereby agrees to maintain the [ * ] included in Schedule [ *
]which may be amended by the Parties during the development.  During this [ * ]
and[ * ], ImmunoGen will keep BI informed on a regular basis and [ * ] be [ * ]
to [ * ] and [ * ] to such[ * ], as appropriate.

 

(e)                                  ImmunoGen shall provide the necessary
documentation and assist BI in preparation of the chemical, pharmaceutical, and
analytical sections of regulatory submissions for IND or foreign equivalent.

 

4.3           Marketing Efforts:

 

(a)                                  BI will use its Commercially Reasonable
Efforts during the Term of this Agreement to commercialise a Licensed Product in
each Major Market in which such Licensed Product is approved for marketing. 
Notwithstanding BI’s [ * ]to[ * ] in[ * ], BI shall not discontinue such efforts
for any reason other than Force Majeure, mutual agreement of the parties and/or
material adverse side effects in rendering such Licensed Product unsuitable as a
medicine for human use.

 

(b)                               With respect to each country in the Territory
that is not a Major Market, BI shall have the right to determine, in its sole
judgement, whether and to what extent it will commercialise the Licensed Product
in each such country in which the Licensed Product is approved for marketing.

 

13

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

 

(c)                                  All commercialisation efforts undertaken by
BI's Affiliates, Sublicensees and Recognised Agents hereunder shall be
attributable to BI.

 

4.4           Effect of Failure to Use[ * ]

 

In the event that BI fails to use [ * ]as described in Section[ * ], then
ImmunoGen shall have the right to terminate the Agreement in accordance with
Section 13.2.

 

5.             SUPPLY AND MANUFACTURING OBLIGATIONS

 

5.1           Non-clinical Material; Clinical Material; Dedicated Equipment

 

(a)                                  During the Term of this Agreement,
ImmunoGen will[ * ] BI with its [ * ] of [ * ]in [ * ]and [ * ]as well as [ *
]and [ * ]for the [ * ]of [ * ]and [ * ]and [ * ]in [ * ]and in [ * ]in order
for BI to [ * ]of the[ * ], as listed on Schedule [ * ]attached hereto.  BI will
pay ImmunoGen a transfer price for such [ * ]equal to [ * ]of ImmunoGen’s [ *
]of[ * ].  In addition, ImmunoGen will [ * ]BI with [ * ]at least a [ * ]of the
[ * ]in its [ * ].  A [ * ]will be [ * ]and [ * ]until the earlier of the [ * ]
of [ * ] or until[ * ].  For GLP material, ImmunoGen will provide a Certificate
of Analysis for each batch manufactured.

 

(b)                                 In the event that, over a given[ * ],[ * ]to
[ * ]with [ * ]of its [ * ]of [ * ]for that [ * ]in the [ * ]as specified in
Schedule [ * ]and such [ * ]is not attributable to a [ * ]set forth in Section [
* ]  or BI’s [ * ] to [ * ] an [ * ] of [ * ] in a timely manner, then, subject
to the [ * ] of [ * ] Section[ * ],[ * ]as follows.  If such [ * ] to [ * ] to[
* ], then [ * ]the [ * ]and [ * ]to Section[ * ].  If [ * ]to [ * ]of[ * ], then
[ * ] the [ * ] and [ * ] to Section[ * ].  The foregoing notwithstanding, [ * ]
the [ * ] of the [ * ] to [ * ]such [ * ] and [ * ]

 

(c)                                  In addition, [ * ] with such [ * ] of [ * ]
in order for BI to [ * ] until [ * ]of [ * ] and[ * ]. The terms and conditions
of the supply of Drug Product shall be governed by the Clinical Supply Agreement
between ImmunoGen and Boehringer Ingelheim Pharma KG (“BI Pharma”) attached
hereto as Schedule G.

 

(d)                                 If ImmunoGen determines that it is necessary
or advisable to purchase dedicated equipment in order to manufacture
non-clinical Drug Substance for BI, BI will reimburse ImmunoGen for the cost of
procuring such dedicated equipment[ * ].  In case of termination, ImmunoGen
shall permit BI to remove such dedicated equipment at BI’s sole cost and
expense.

 

(e)                                  The [ * ] in Section [ * ] and [ * ] of the
Clinical Supply Agreement shall also apply for non-clinical material.

 

14

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

 

5.2           Technology Transfer.

 

As soon as reasonably practicable following the Effective Date, ImmunoGen will
transfer to BI and its agents such Technology within its Control related to the
Licensed Technology and [ * ] as may be reasonably required by BI for the [ * ]
of [ * ] in accordance with the [ * ] to be agreed upon by BI and ImmunoGen
before[ * ], the major terms of which are attached hereto as Schedule[ * ].

 

6.             PRODUCT INQUIRIES, COMPLAINTS AND ADVERSE EVENTS

 

6.1           Medical/Scientific Product Inquiries:

 

(a)                                  BI shall be solely responsible for
responding to all medical questions and inquiries relating to the Licensed
Products in each country in the Territory.

 

(b)                                 In conjunction with the marketing and sale
of Licensed Products in a country in the Territory, BI shall be solely
responsible for providing (i) medical, technical and scientific information
concerning Licensed Product to healthcare professionals, managed care
organisations, sales representatives, medical publishers, consumers, patient
assistance programs and others who may request such information, and (ii)
after-hours coverage to address emergency requests for medical, technical and
such scientific information concerning the Licensed Products.

 

6.2           Adverse Medical Events and Complaints:

 

BI agrees to provide ImmunoGen with Adverse Event information and product
complaint information relating to Licensed Products as compiled and prepared by
BI in the normal course of business in connection with the development,
commercialization or sale of any Licensed Product, within time frames consistent
with reporting obligations under applicable laws and regulations. [ * ] agrees
to [ * ] with [ * ] and [ * ] to[ * ] that is [ * ] and [ * ] by [ * ] or [ * ]
in the normal course of business in connection with the [ * ] or [ * ] of any
such[ * ], within time frames consistent with reporting obligations under
applicable laws and regulations; provided, however, that the foregoing shall not
require [ * ] to [ * ]any[ * ] with or [ * ] owed to[ * ].  ImmunoGen, in [ * ]
in which it has [ * ]or [ * ] a [ * ] under the [ * ] and[ * ],[ * ]or[ * ], as
the case may be, a [ * ] to [ * ] of [ * ] to the [ * ] that is the [ * ] of
such[ * ].[ * ] will [ * ] and [ * ] these [ * ] and will [ * ] to [ * ] all [ *
]which is relevant for the [ * ] of the [ * ] and its [ * ] to[ * ].  [ *
]hereby affirms to [ * ] that such [ * ] is not [ * ] the [ * ] owes to[ * ]. 
BI shall provide its Adverse Event and product complaint information hereunder
to ImmunoGen’s designated representative, who shall be its Chief Regulatory
Officer unless ImmunoGen otherwise notifies BI. [ * ] shall [ * ] its [ * ]and [
* ] hereunder to [ * ] designated representative, who shall be the head of its
Drug Safety group in [ * ] unless [ * ] otherwise notifies[ * ].

 

15

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

 

7.             RIGHTS AND IMPROVEMENTS

 

7.1           Ownership of Technology and Proprietary Materials:

 

All BI Intellectual Property and BI Materials shall be sole and exclusive
property of BI and may be used by BI in any manner BI, in its sole discretion,
deems appropriate to exercise its rights under this Agreement.  All Licensed
Technology and ImmunoGen Materials shall be sole and exclusive property of
ImmunoGen and may be used by ImmunoGen in any manner ImmunoGen, in its sole
discretion, deems appropriate, to exercise its rights under this Agreement,
subject to the grant of the licenses to BI described in this Agreement.

 

7.2           [ * ]:

 

(a)                                  [ * ]will [ * ]to [ * ]any and all [ * ]or
[ * ]or [ * ]it or [ * ]under its [ * ] during [ * ] of this Agreement to the
extent such [ * ] are related to [ * ] or are [ * ] or [ * ] to [ * ] and[ * ].

 

(b)                                 To the extent any [ * ] was [ * ] or [ * ]
or [ * ] and [ * ] (a “[ * ] ”), such [ * ] shall be [ * ] by [ * ] and[ * ]. 
ImmunoGen and BI each hereby represents that all employees and other persons
acting on its behalf in performing its obligations under this Agreement shall be
obligated under a binding written agreement or the applicable law to [ * ] to it
or as it [ * ]all [ * ] or [ * ] by such employees or other persons.

 

(c)                                  To the extent any [ * ] was [ * ] or [ * ]
or [ * ] one party, the [ * ] shall be [ * ] .

 

8.             PATENTS AND TRADEMARKS

 

8.1           Patent Prosecution:

 

(a)                                  ImmunoGen agrees to use commercially
reasonable effort to continue, [ * ] , the prosecution and maintenance of the
Licensed Patent Rights; provided, however, that ImmunoGen shall keep BI fully
and timely informed in respect of the course and conduct of patent application
prosecution matters pertaining to Licensed Products. Prosecution and maintenance
of Licensed Patent Rights shall include, but not be limited to, prosecuting
pending patent applications therein and maintaining and extending patents
therein, including in any defensive proceedings such as oppositions and the like
and any reissue or re-examination proceedings, in any country in the Territory
should such actions be reasonably deemed necessary or desirable by ImmunoGen.
ImmunoGen shall keep BI advised of the status of such prosecution and
maintenance by timely providing BI with copies of all patent applications and
patents, and all official communications with respect to such patent
applications and patents, contained in the Licensed Patent Rights for the
purpose of obtaining substantive comment of BI patent counsel.

 

16

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

 

(b)                                 As regards any Patent Rights covering Joint
Improvements, ImmunoGen will have the first right, but not the obligation, to
undertake filing(s), prosecution and maintenance of inventorship certificate(s),
patent application(s) and patent(s) thereon. ImmunoGen shall advise BI within [
* ] whether it will file any such patent application with respect to any Joint
Improvements.  If ImmunoGen fails to undertake the filing(s) of any such patent
application within [ * ] after receipt of written notice from BI that it
believes filing(s) of such an application by ImmunoGen is appropriate, BI may
undertake such filing(s) at its own expense.   In connection with any such
filing(s), the filing party will file, prosecute and maintain such patent
application in the name of both parties jointly.    In any case, the filing
party (i) will provide the non-filing party with a copy of any such proposed
patent application for review and comment reasonably in advance of filing, and
(ii) will keep the non-filing party reasonably informed of the status of such
filing, prosecution and maintenance.  Costs of any such filing, prosecution and
maintenance shall be shared jointly by the parties.

 

8.2           Patent Abandonment:

 

If ImmunoGen elects to abandon any patent application or patent included within
the Licensed Patent Rights, and/or terminate its future obligations to prosecute
and maintain any such patent application or patent, then it shall provide BI
with [ * ] prior written notice of its election.  If BI notifies ImmunoGen
within such [ * ] response period, that it wishes to prosecute or maintain such
patent application or patent at its own expense, then ImmunoGen shall promptly
transfer and assign such patent application or patent to BI and continue to
prosecute and maintain such patent application or patent or until such transfer
and assignment become effective. Upon such transfer and assignment becoming
effective, such patent application or patent shall no longer be considered to be
included within the Licensed Patent Rights, and ImmunoGen and its employees
shall thereafter reasonably assist BI in the prosecution and maintenance of such
patent application or patent; provided, however, that such assistance shall be
subject to BI's reimbursement of ImmunoGen's out-of-pocket expenses with respect
thereto.

 

8.3           Trademarks:

 

BI, in its sole discretion, in its own name and at its own expense, may prepare
or develop, adopt and register all trademarks, trade names, brand names and
logos for use with the Licensed Products. These trademarks, trade names, brand
names and logos shall be and shall remain the sole and exclusive property of BI.
All use of such trademarks, trade names, brand names and logos shall inure to
the sole benefit of BI. BI shall remain the owner of the trademarks, trade
names, brand names and logos and the goodwill associated with the same and
ImmunoGen agrees not to assert any ownership interest in such trademarks, trade
names, brand names and logos or the goodwill associated therewith.

 

17

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

 

9.             INFRINGEMENT

 

9.1           Infringement of Third Parties’ Rights:

 

(a)                                  Notice.  If the development, registration,
manufacture, use, marketing or sale of the Licensed Products results in a claim
against a party of infringement or misappropriation of any third party’s patent
or other intellectual property right (“Third-Party Claim”), the party first
having notice of a Third-Party Claim shall promptly notify the other party in
writing specifying in reasonable detail the alleged grounds or basis for the
Third-Party Claim (to the extent known).

 

(b)                                 Patent Infringement Claims.  If the
development, registration, manufacture, use, marketing or sale of Licensed
Products in a country in the Territory results in a Third-Party Claim of patent
infringement, the parties agree to respond to and/or defend against the
Third-Party Claim as follows:

 

(i)                                     Control of Defence.  ImmunoGen shall
have the initial right to manage solely the defence of the parties against the
Third-Party Claim.  If ImmunoGen elects to exercise such right as to the
Third-Party Claim, BI shall cooperate with ImmunoGen at ImmunoGen’s request and
shall have the right to be represented by counsel selected and paid for by BI. 
If ImmunoGen elects not to exercise such right as to the Third-Party Claim, BI
shall have the right to manage solely the defence of the parties against the
Third-Party Claim and ImmunoGen shall cooperate with BI at BI’s request and
shall have the right to be represented by counsel selected by ImmunoGen.

 

(ii)                                  Settlements.  The party that manages
solely the defence of the parties against the Third-Party Claim shall also have
the right to settle such Third-Party Claim on terms deemed appropriate by such
party provided, however, that (A) neither party shall settle any Third-Party
Claim in a manner that is prejudicial to the Licensed Products, (B) such party
shall consult with the other party concerning the terms of any settlement
agreement before entering into such an agreement, and (C) neither party shall
settle any such Third-Party Claim without the prior written consent of the other
party, which consent shall not be unreasonably withheld.

 

(iii)                               Costs of Defence.  Each party shall be
responsible for its own fees and costs of attorneys and consultants, together
with the court costs, incurred in defending against the Third-Party Claim.

 

9.2           Infringement Claims against Third Parties:

 

ImmunoGen agrees during the Term of this Agreement to take reasonable actions to
protect the Licensed Patent Rights from infringement and the Licensed Technology
from unauthorised possession or use.

 

(a)           A party first having knowledge of any infringement or
misappropriation, or knowledge of a reasonable probability of such infringement
or misappropriation, by a third party, including that contained in a notice
provided under the 1984 Act by a party filing an ANDA or Paper NDA for Licensed
Products, or an equivalent action in any other country of the world, shall
promptly notify the other party in writing. ImmunoGen shall institute,
prosecute, and control, at its own expense and with counsel of its own choosing,
any action or proceeding against the third party with respect to such
infringement or misappropriation, and keep BI informed of the progress of such
enforcement proceeding and shall give due consideration to the suggestions or
comments of BI in connection therewith.

 

 

18

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

 

(b)                                 If ImmunoGen fails to act within a period of
[ * ] after receiving notice of the infringement in a country in the Territory,
BI shall have the right to bring and control, at its own expense, any such
action by counsel of its own choice.  If BI brings any such action or
proceeding, ImmunoGen may be joined as a party plaintiff and ImmunoGen agrees to
give BI reasonable assistance to file and to prosecute such suit.

 

(c)                                  To the extent that ImmunoGen or BI
initiates and prosecutes a proceeding under Section 9.2 on its own, without the
material assistance of or the participation as a co-plaintiff in the action by
the other party, then the party that prosecuted the action shall be entitled to
retain for its sole and exclusive benefit any damages or other monetary award
recovered therein in its favour.

 

(d)                                 To the extent that both ImmunoGen and BI
materially assist or participate in, or, pursuant to Section 9.2(b) above, are
both parties to, any such proceeding, then:

 

(i)                                     the costs and expenses of each of
ImmunoGen and BI under this Section 9.2(d) shall be [ * ] to[ * ], based on the
[ * ] by[ * ], out of any [ * ] or other [ * ] therein in favour of ImmunoGen
and/or BI; and

 

(ii)                                  the amount of any [ * ] or other[ * ]
therein in favour of ImmunoGen and/or BI, in excess of the [ * ] provided for in
clause (i) above, shall be [ * ] as follows:  (1) first, to[ * ], as [ * ] for [
* ]associated with [ * ] and to [ * ] as [ * ] for [ * ] to the extent that the
[ * ] or [ * ] is [ * ] to [ * ] associated with[ * ]; and (ii) second, any
amounts remaining shall be allocated as follows: (a) if [ * ] is the party
prosecuting such action, [ * ] to[ * ], (b) if [ * ] is the party prosecuting
such action, [ * ] to [ * ] and [ * ] to[ * ], and (c) if both parties are
prosecuting such action, [ * ] to[ * ].

 

10.          REPRESENTATIONS AND WARRANTIES

 

10.1         ImmunoGen Representations:

 

ImmunoGen represents and warrants to BI that:

 

(a)                                  No Conflict. The execution, delivery and
performance of this Agreement by ImmunoGen does not conflict with any agreement,
instrument or understanding, oral or written, to which it is a party or by which
it may be bound, and does not violate any law or regulation of any court,
governmental body or administrative or other agency having authority over it,
including, without limitation, 35 U.S.C.A. Sections 203 and 204.  ImmunoGen is
not currently a party to, and during the Term of this Agreement will not enter
into, any agreements, oral or written, that are inconsistent with its
obligations under this Agreement.

 

19

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

 

(b)                                 Authority. ImmunoGen is validly existing and
in good standing under the laws of the state of its incorporation and has the
corporate power and authority to enter into this Agreement. The execution,
delivery and performance of this Agreement have been duly authorized by all
necessary action on the part of ImmunoGen, its officers and directors.

 

(c)                                  Ownership. To ImmunoGen’s knowledge, all of
the Licensed Patents are subsisting and are valid and enforceable. ImmunoGen (i)
has not previously assigned, transferred, conveyed or otherwise encumbered its
right, title and interest in Licensed Patents, or any component of the Licensed
Technology, and (ii) has no knowledge of the existence of any patent, trademark
or other intellectual property right (other than any patent application) owned
or controlled by ImmunoGen, other than the Licensed Patent Rights, in case of
either (i) or (ii), that would prevent ImmunoGen and BI from manufacturing and
supplying Licensed Products, and BI from exploiting its rights granted under
Section 2.1.  In addition, ImmunoGen has no knowledge of the existence of any
patent or intellectual property right (other than any patent application) owned
or Controlled by a third party that would materially conflict with the grant of
the license set forth in Section 2.1 of this Agreement.

 

(d)                                 Litigation. There are no claims, judgements
or settlements against, pending with respect to the Licensed Patents or any
component of Licensed Technology. In addition, to ImmunoGen's knowledge, no such
claims, judgements or settlements are threatened.

 

(e)                                  Further Warranties:

 

ImmunoGen covenants to BI that:

 

(i)                                     The development and manufacture of DM1
by ImmunoGen under this Agreement shall be in compliance with the laws,
requirements and regulations applicable thereto in the Territory.

 

(ii)                                  The documentation to be provided to BI
pursuant to Section 5.2 will, at the time of transfer to BI, contain all
material know-how and information then in ImmunoGen’s Control relating to the
production of Licensed Products.

 

(iii)                               All Certificate of Analysis documents which
will be provided to BI under this Agreement shall be generated and documented in
accordance with generally accepted standards of the pharmaceutical industry.

 

20

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

 

(iv)                              All[ * ], submitted to [ * ] by [ * ] in [ * ]
to[ * ], regarding Licensed Technology and Licensed Patent Rights is, to the
best of ImmunoGen’s knowledge, accurate in all material respects.

 

10.2         BI Representations and Warranties:

 

BI represents, warrants and covenants to ImmunoGen that:

 

(a)                                  No Conflict. The execution, delivery and
performance of this Agreement by BI does not conflict with any agreement,
instrument or understanding, oral or written, to which it is a party or by which
it may be bound, and does not violate any law or regulation of any court,
governmental body or administrative or other agency having authority over it. 
BI is not currently a party to, and during the term of this Agreement will not
enter into, any agreements, oral or written, that are inconsistent with its
obligations under this Agreement.

 

(b)                                 Authority. BI is validly existing and in
good standing under the laws of the state of its incorporation and has the
corporate power and authority to enter into this Agreement. The execution,
delivery and performance of this Agreement have been duly authorized by all
necessary action on the part of BI, its officers and directors.

 

10.3         Warranty Disclaimer.

 

Except as otherwise expressly provided in this agreement, neither party makes
any warranty with respect to any technology, goods, services, rights or other
subject matter of this Agreement and hereby disclaims warranties of
merchantability, fitness for a particular purpose and noninfringement with
respect to any and all of the foregoing.

 

11.          INDEMNIFICATION

 

11.1         Indemnification by the Parties:

 

Each party (the "Indemnitor") will indemnify the other party (the "Indemnitee")
against any liability in connection with any claim, suits, liabilities, etc.
arising out of the performance by the Indemnitor of its work under the Agreement
or the exploitation by the Indemnitor of its rights under the Agreement,
including, without limitation, the development, manufacture, promotion, or sale
of Licensed Products, unless such liability results from (i) the negligence or
wilful misconduct of the Indemnitee or (ii) a breach of the warranties set forth
in the Agreement by the Indemnitee.

 

11.2         Indemnification Procedures:

 

(a)                                  The Indemnitee shall: (i) notify the
Indemnitor of any liability and full details of the basis therefor with respect
to which the Indemnitee intends to claim indemnification as soon as practicable
after the Indemnitee becomes aware of any such liability; (ii) permit the
Indemnitor to assume the defence thereof; and (iii) cooperate with the
Indemnitor, at the Indemnitor’s expense, in the defence thereof.

 

21

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

 

(b)                                 With respect to any matter for which the
Indemnitor has an obligation to indemnify the Indemnitee under this Agreement,
the Indemnitee shall have the right to participate and be represented (at the
Indemnitor’s expense) by legal counsel of the Indemnitee’s choice in all
proceedings and negotiations, if representation by counsel retained by
Indemnitor would be inappropriate due to actual or potential differing interests
between the Indemnitee and any other party represented by such counsel in such
proceedings.

 

(c)                                  The indemnity agreement in this Section 11
shall not apply to amounts paid in settlement of any liability if such
settlement is effected without the consent of the Indemnitor, which consent
shall not be unreasonably withheld.

 

(d)                                 Failure of the Indemnitee to deliver notice
to the Indemnitor within thirty (30) days after becoming aware of a liability
shall relieve the Indemnitor of any liability to the Indemnitee pursuant to this
Section 11 in the event, but only to the extent, such delay is prejudicial to
the Indemnitor’s ability to defend such action.

 

12.          CONFIDENTIALITY

 

12.1         Confidential Information:

 

All data, information, documents and materials transmitted by BI to ImmunoGen or
by ImmunoGen to BI in conjunction with this Agreement, including, but not
limited to, all scientific, technical and clinical data, information reports,
financial or business records, forecasts, orders, summaries and information
gathered, generated or transferred by a party during the course of this
Agreement is considered confidential and proprietary information of the
disclosing party (hereinafter “Confidential Information”). The parties shall use
the Confidential Information only for the purpose of executing their rights and
fulfilling their obligations under this Agreement.

 

12.2         Disclosure:

 

(a)                                  Upon execution of this Agreement and
thereafter on an ongoing basis during the Term of the Agreement, each party
shall disclose to the other party, in confidence, subject to the terms of this
Section 12, information required by the other party in order to execute its
rights and fulfil its obligations pursuant to this Agreement. Notwithstanding
the foregoing, a party shall not be obligated to disclose to the other party any
information that it is prohibited from disclosing to the other party, either by
reason of a contract with a third party or by law. In the event of such a
restriction, the parties shall cooperate and take such legally permissible
action as may be reasonable to permit such disclosure to be made.

 

(b)                                 The receiving party shall not disclose,
without prior written consent of the disclosing party, any Confidential
Information to any third party other than officers, directors, Affiliates and
representatives of the receiving party and to third parties mentioned in Section
2.4. When the receiving party does disclose information, it will only be on a
need to know basis, including, without limitation, fulfilment of corporate
reporting required by law or regulation, hospital authorities, regulatory
authorities and others who have agreed in writing to observe the confidentiality
of Confidential Information in the same manner and to the same extent as
provided in this Section 12.

 

22

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

 

12.3         Publications

 

(a)                                  In recognition of BI’s assumption of
development and marketing responsibilities in connection with the Licensed
Product, and in order to assure consistency with BI’s marketing plans, except
for submissions of manuscripts, abstracts or other publications made prior to
the Effective Date, ImmunoGen, its Affiliates, their employees, clinical
investigators or consultants shall not have the right to make any public
disclosure of information, whether oral or in writing, concerning the
pre-clinical and/or clinical trial activities and/or results pertaining
specifically to Licensed Products without the express written consent of BI,
which consent may be withheld in BI’s sole discretion.  BI shall be entitled to
publish scientific information and data, including the results of clinical
trials, as it deems appropriate, to advance the commercialization of the
Licensed Product, subject to subsection (b) below.

 

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

 

12.4         Obligation to Obtain Agreements:

 

The obligations of the receiving party regarding the confidentiality and
nondisclosure of Confidential Information shall extend to and be binding upon
all employees or agents of the receiving party who have access to Confidential
Information pursuant to this Agreement as if such employees or agents were
parties hereto.

 

12.5         Exceptions:

 

The obligations of the receiving party regarding the confidentiality and
nondisclosure of information as provided in this Section 12 shall not apply to
certain information if it can be demonstrated by written documentation or other
adequate proof that such information:

 

(a)                                  Is already known to the receiving party as
shown by competent written records;

 

(b)                                 Is or becomes publicly available through no
fault of the receiving party;

 

23

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

 

(c)                                  Is disclosed to the receiving party by a
third party not subject to an obligation of confidentiality to the disclosing
party respecting such information;

 

(d)                                 Is required to be disclosed by law,
regulation, order, decree or subpoena or other legal process; provided that the
receiving party has used reasonable efforts to obtain a protective order and has
taken reasonable actions to avoid further disclosure of such information to any
party not part of such requirement; or

 

(e)                                  Is independently developed by the receiving
party without reliance on information provided by the disclosing party as shown
by competent written records.

 

12.6         Public Disclosure:

 

Neither ImmunoGen nor BI shall issue a press release or in any other way
announce to the public the existence, terms, conditions of, or performance under
this Agreement without the prior written consent of the other party, which
consent shall not be unreasonably withheld or delayed, unless the existence,
terms, conditions of, or performance under this Agreement is required to be
disclosed by law, regulation, order, decree or subpoena or other legal process;
provided that the party ordered to so announce has used reasonable efforts to
obtain a protective order or other applicable protection against further
disclosure or release or announcement of such information.  The parties shall
mutually agree on the text of a press release announcing the execution of this
Agreement and on any confidential treatment request(s) to be filed with the
Securities and Exchange Commission with respect to this Agreement.  Once any
written text is approved for disclosure by both parties as provided herein,
either party may make subsequent or repeated public disclosures of the contents
thereof without the further approval of the other party.  Nothing in the
foregoing, however, shall prohibit a party from making such disclosures
regarding this Agreement or the terms thereof to the extent deemed necessary
under applicable federal or state securities laws or any rule or regulation of
any nationally recognized securities exchange, subject to the terms of Section
12.5 above regarding disclosures required to comply with applicable laws,
regulations or court order.

 

13.          TERM AND TERMINATION

 

13.1         Term:

 

Unless earlier terminated pursuant hereto, the term of this Agreement (the
“Term”) shall continue on a country-by-country basis through the last to expire
of any obligation of BI to pay a royalty to ImmunoGen hereunder in such
countries in the Territory. However, in the European Union the obligation of
ImmunoGen not to license or exploit by itself the Licensed Technology shall
expire on a country-by-country basis after expiration of the Licensed Patent
Rights in the respective country or after [ * ] from [ * ] of the respective
Licensed Product, whichever is the longer.

 

13.2         Early Termination:

 

Notwithstanding Section 13.1, either party may, in addition to exercising any
other  available legal or equitable rights or remedies, terminate this
Agreement, effective immediately upon the expiration of any applicable cure
period, upon the occurrence of an Event of Default (as defined below) with
respect to the other party.  The term “Event of Default” with respect to a party
means the occurrence of any of the following events:

 

24

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

 

 

(a)                                  The failure of a party to comply with or
perform any material provision of this Agreement, and such failure remains
uncured for [ * ] following written notice of such failure (if such default is
cured within the cure period, such written notice shall be null and void),
provided that, if the defaulting party can establish to the reasonable
satisfaction of the other party that it is diligently and actively pursuing a
cure at the expiration of the cure period, and that the default is reasonably
capable of being cured, then the cure period shall be extended for so long as a
cure is being diligently and actively pursued, not to exceed [ * ] and [ * ] in
the aggregate.

 

(b)                                 A party (i) becomes unable to pay its debts
as they mature, (ii) is the subject of a voluntary or involuntary petition in
bankruptcy or of any other proceeding under bankruptcy, insolvency or similar
laws which, if involuntary, is not dismissed within [ * ] of the date filed,
(iii) makes an assignment for the benefit of creditors, (iv) is named in, or its
property is subject to, a suit for the appointment of a receiver which is not
dismissed within [ * ]of the date filed, or (v) is dissolved or liquidated.

 

13.3         Termination by BI:

 

BI has the right to terminate this Agreement for any reason at any time upon [ *
] advance written notice given to ImmunoGen.

 

14.          EFFECTS OF TERMINATION

 

14.1         Further Licenses/Reversion of Rights:

 

(a)                                  Upon the expiration of this Agreement
pursuant Section 13.1, on a country by country basis, BI shall have a
non-exclusive, irrevocable, fully paid-up, royalty free license to use and
exploit the Licensed Technology in such country.

 

(b)                                 In the event this Agreement is terminated by
BI in accordance with Section 13.2(a) of this Agreement as a result of the grant
by ImmunoGen to a third party of a license under the Licensed Technology and/or
Licensed Patent Rights in violation of the exclusive license granted to BI under
Section 2.1, BI’s [ * ] under [ * ]  of this Agreement shall [ * ] a[ * ].

 

(c)                                  In the event this Agreement is terminated
for any other reason other than as described in Section 14.1(a) and (b) above,
all rights granted to BI under Section 2.1 shall terminate and revert to
ImmunoGen.

 

14.2         Inventory:

 

If either party terminates this Agreement, then BI shall have the right, within
[ * ] after such termination, to sell off its remaining inventory of Licensed
Product and pay ImmunoGen all royalties on account thereof.

 

25

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

 

14.3         Other Penalties:

 

(a)                                  Termination of this Agreement by either
party shall not prejudice the rights of such party under this Agreement, at law
or in equity or otherwise, to seek damages or injunctive relief for any breach
of this Agreement by the other party hereto and all payment obligations accruing
under this Agreement prior to the effective date of termination.

 

(b)                                 Except as otherwise provided in this
Agreement, neither ImmunoGen nor BI will be liable with respect to any subject
matter of this Agreement under any contract, negligence, strict liability or
other legal or equitable theory for any punitive damages or indirect,
incidental, consequential damagesor lost profits, including, without limitation,
cost of procurement of substitute goods or technology, or loss of opportunity,
loss of income or compensation for loss of goodwill.

 

14.4         Accrued Rights:

 

Termination of this Agreement for whatever reason shall not affect the accrued
rights of either ImmunoGen or BI arising under or out of this Agreement.  The
obligations under any other provision that expressly or by implication are
intended to survive expiration or termination shall survive expiration or
termination of this Agreement.

 

14.5         Confidential Information.

 

Upon the expiration or termination of this Agreement, the receiving party will
upon request from the disclosing party promptly return to the disclosing party
all of the Confidential Information in the receiving party’s possession, as well
as all written information and materials that incorporate Confidential
Information; provided, however, that the receiving party may keep (i) all
information and material that incorporate Confidential Information necessary to
exploit the receiving party’s rights set forth in Section 14 and/or (ii) one (1)
copy of such Confidential Information, or as required by applicable laws, rules
or regulations, subject to the confidentiality provisions contained herein.

 

15.          MISCELLANEOUS

 

15.1                           Either party shall not be entitled to assign or
otherwise transfer its rights and obligations under this Agreement in whole or
in part to any third party without the prior written consent of the other party.

 

15.2                           This Agreement set forth the entire agreement
between the parties and supersedes all previous agreements, written or oral
regarding the subject matter hereof. This Agreement may be amended only by an
instrument in writing duly executed on behalf of the parties.

 

15.3                           Neither party shall be liable for delay or
failure to perform hereunder due to any contingency beyond its control,
including but not limited to acts of God, fires, floods, wars, civil wars,
sabotage, strikes, governmental laws, ordinances, rules or regulations or
failure of third party delivery, provided, such party promptly gives to the
other party hereto written notice claiming for force majeure and uses its best
efforts to eliminate the effect of such force majeure, insofar as is possible
and with all reasonable dispatch. If the period of delay or failure should
extend for more than [ * ] then either party shall have the right to terminate
this Agreement forthwith upon written notice at any time after expiration of
said [ * ] period.

 

26

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

 

15.4                           Any waiver shall be made in writing for it to be
effective and unless expressly stated shall not be a continuing waiver nor shall
it prevent the waiving party from acting upon that or any subsequent breach or
from enforcing any term or condition of this Agreement.

 

15.5                           The invalidity of any provision of this Agreement
or any loophole in this Agreement shall not affect the validity of any other
provision hereof. The parties undertake to replace the invalid provision or
close the loophole in the Agreement with another provision which reflects
legally the originally intended commercial objectives of the parties as closely
as possible.

 

15.6                           This Agreement shall be governed exclusively by[
* ]. In the event of any controversy or claim arising out of or relating to any
provision of this Agreement, the parties shall first try to settle those
conflicts amicably between themselves. Any dispute, controversy or claim
initiated by either party arising out of, resulting from or relating to this
Agreement, or the performance by either party of its obligations under this
Agreement (other than bona fide third party actions or proceedings filed or
instituted in an action or proceeding by a third party against a party), whether
before or after termination of this Agreement, shall be finally resolved by
binding arbitration.  Whenever a party shall decide to institute arbitration
proceedings, it shall give written notice to that effect to the other party. 
Any such arbitration shall be conducted under the commercial arbitration rules
of the ICC by a panel of three arbitrators appointed in accordance with such
rules.  Any such arbitration shall be held in[ * ].  The arbitrators shall have
the authority to grant specific performance and to allocate between the parties
the costs of arbitration in such equitable manner as they determine.  Judgment
upon the award so rendered may be entered in any court having jurisdiction or
application may be made to such court for judicial acceptance of any award and
an order of enforcement, as the case may be.  In no event shall a demand for
arbitration be made after the date when institution of a legal or equitable
proceeding based upon such claim, dispute or other matter in question would be
barred by the applicable statute of limitations.  Notwithstanding the foregoing,
either party shall have the right, without waiving any right or remedy available
to such party under this Agreement or otherwise to seek and obtain from any
court of jurisdiction any interim or provisional relief that is necessary or
desirable to protect the rights or property of such party, pending the selection
of the arbitrators hereunder or pending the arbitrators’ determination of any
dispute, controversy or claim hereunder.

 

15.7                           In the performance of this Agreement each party
shall be an independent contractor, and therefore, no party shall be entitled to
any benefits applicable to any employee of the other party. No party is
authorised to act as an agent for the other party for any purpose, and no party
shall enter into any contract, warranty or representation as to any matter on
behalf of the other party.

 

27

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

 

16.          SCHEDULES

 

A reference to the terms of this Agreement shall be meant to include all
Schedules.  The following Schedules are incorporated and made part of this
Agreement:

 

Schedule A.  Licensed Technology

 

Schedule B.  Licensed Patent Rights

 

Schedule C.  BI Intellectual Property

 

Schedule D.  Provision of Non-clinical BIWI1

 

Schedule E.  Major Terms of Technical Transfer Plan

 

Schedule F:  Development Plan

 

Schedule G.  Clinical Supply Agreement

 

[Remainder of page intentionally left blank]

 

28

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

 

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
in triplicate by their duly authorised representatives.

 

Boehringer Ingelheim International GmbH

ImmunoGen, Inc.

ppa.

 

 

 

 

 

 

 

Dr. K. Wilgenbus

Claudia Jesse

 

Pauline Jen Ryan

 

 

29

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

 

Schedule A

Licensed Technology

 

[ * ] (including [ * ] for [ * ] of[ * ],[ * ]of [ * ]to[ * ],[ * ]of[ * ],[ *
]of [ * ] to[ * ],[ * ] of[ * ], and [ * ] of [ * ] and [ * ] and [ * ] in
biological material and in Drug Substance and Drug Product preparations).

 

A-1

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

 

Schedule B

Licensed Patent Rights

 

[ * ]

 

Attorney Reference No.

Country

Appl. No.

Filing Date

Priority Date

Patent No.

Issue Date

Exp. Date

 

 

 

 

 

 

 

 

[ * ]

[ * ]

[ * ]

[ * ]

 

[ * ]

 

 

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

 

 

 

 

 

 

 

 

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

 

[ * ]

 

 

 

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

 

 

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

 

 

 

 

 

 

 

 

 

[ * ]

 

Attorney Reference No.

Country

Appl. No.

Filing Date

Priority Date

Patent No.

Issue Date

Exp. Date

[ * ]

[ * ]

[ * ]

[ * ]

 

[ * ]

 

 

 

 

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

 

 

 

 [ * ] (2)

 

Attorney Reference No.

Country

Appl. No.

Filing Date

Priority Date

Patent No.

Issue Date

Exp. Date

[ * ]

[ * ]

[ * ]

[ * ]

 

[ * ]

 

 

 

 

 

[ * ]

 

Attorney Reference No.

Country

Appl. No.

Filing Date

Priority Date

Patent No.

Issue Date

Exp. Date

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

 

 

 

 

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

 

B-1

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

 

Schedule C

BI Intellectual Property

 

[ * ]

Subject

Expiry and Status Europe

Expiry and Status US

File No. EP
and US

Geographic Coverage

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

 

C-1

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

 

Schedule D

Provision of [ * ]

 

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

 

 

 

[ * ]

[ * ]

 

 

 

[ * ]

[ * ]

[ * ]

 

 

[ * ]

[ * ]

[ * ]

 

 

[ * ]

 

 

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

 

 

[ * ]

[ * ]

[ * ]

 

 

[ * ]

[ * ]

[ * ]

 

 

[ * ]

[ * ]

 

 

 

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

[ * ]

TOTAL

[ * ]

[ * ]

[ * ]

[ * ]

 

D-1

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

 

Schedule E

Major Terms of [ * ]

 

It is the intention of the parties that the [ * ] referenced in Section [ * ] 
of this Agreement will be finalised by the parties as soon as practicable and in
any event no later than[ * ].  Both parties agree to negotiate such finalized
terms in good faith, which shall be based on the [ * ] by [ * ] to [ * ] of
following documentation, to the extent available:

 

For [ * ] purposes:

 

[ * ]:

•               [ * ]and [ * ]for [ * ]of the [ * ]covering [ * ] and [ * ] ([ *
]for [ * ]including[ * ])

•               [ * ]and [ * ] for [ * ] covering [ * ] for[ * ],[ * ]and [ * ]
([ * ]for [ * ]including[ * ], and[ * ])

•               [ * ]of the [ * ]

•               [ * ]of [ * ] for [ * ]

•               [ * ]for[ * ] ([ * ])

•               [ * ]of all[ * ] of[ * ]

•               [ * ]for [ * ]([ * ]and [ * ] conditions)

 

[ * ]:

•               [ * ]for all [ * ] of the [ * ] ([ * ])

•               [ * ]of [ * ]([ * ])

•               [ * ]of all [ * ](in [ * ]and[ * ])

 

For [ * ]Purposes:

 

•               [ * ]of [ * ]([ * ])

•               [ * ]for [ * ]

•               [ * ]for [ * ](see below)

•               [ * ] ([ * ]) of each [ * ](see below)

 

[ * ]of “[ * ]”:

•               [ * ]

•               [ * ]

•               [ * ]

•               [ * ]

•               [ * ]

•               [ * ]

•               [ * ]

 

For[ * ] purposes:

 

ImmunoGen will [ * ]BI with [ * ]that are [ * ]for [ * ](e.g. [ * ]etc.).

ImmunoGen will [ * ]BI with all required [ * ]and [ * ]on [ * ]of[ * ].

 

E-1

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

 

For [ * ]purposes:

 

•    Information about [ * ]for[ * ], including [ * ]for any steps that [ *
]takes for [ * ]

•    [ * ]for the [ * ]with [ * ]and [ * ]for [ * ]and [ * ]

•    [ * ]of [ * ]used in the [ * ]

•    [ * ]for each [ * ]of the [ * ]([ * ]and[ * ])

•    [ * ]regarding the [ * ]

•    [ * ]about different[ * ], additional information which is necessary [ * ]

•    [ * ]about necessary [ * ]for every [ * ]

•    Copies of the [ * ]and [ * ]from [ * ]which were [ * ]at [ * ]

•    [ * ]of each [ * ](i.e. [ * ]of [ * ]of the [ * ]when [ * ]in the [ * ]for
example[ * ])

 

General:

 

ImmunoGen will agree to [ * ]for the collaboration with BI throughout the[ * ].
To the extent practicable, ImmunoGen will attempt to [ * ]in the [ * ](in the [
* ]and[ * ]) who have [ * ]on the [ * ]with BI.

 

ImmunoGen will agree, [ * ] , to [ * ] an [ * ] of [ * ] from BI at [ * ] during
the [ * ] in order to [ * ] such [ * ] in the [ * ] of the [ * ] and [ * ] that
are [ * ] for the [ * ] of[ * ].  Such [ * ] shall take place at [ * ] at
mutually convenient times and shall not exceed an aggregate of in duration.  BI
shall [ * ] the [ * ] and [ * ] of all such[ * ].   ImmunoGen will also agree to
let BI [ * ] the [ * ]of at least [ * ] of[ * ].

 

ImmunoGen will further agree to use [ * ] to make arrangements for BI [ * ] to [
* ]in a [ * ] to[ * ].

 

On not less than [ * ] prior written notice from BI, ImmunoGen will also agree
to [ * ]to the [ * ] for a [ * ] not to exceed [ * ] in the aggregate, while the
[ * ] is being[ * ]. BI will have the right to [ * ] to ImmunoGen as to the [ *
] and [ * ] of such [ * ] desired as well as the [ * ] of such[ * ]. To the
extent practicable, ImmunoGen will attempt to [ * ] in such [ * ] who have [ * ]
on the[ * ].  ImmunoGen and BI will agree to negotiate in good faith any [ * ]
of such[ * ].  BI will agree to [ * ] ImmunoGen for all of its [ * ] in
connection with such [ * ] at [ * ] of [ * ] for[ * ], and [ * ]for [ * ]and[ *
], such as[ * ], will also be [ * ] by BI.

 

It is the [ * ] of the [ * ] that this [ * ] will [ * ] as soon as BI Pharma [ *
] of [ * ]which comply with [ * ] and are [ * ] for [ * ] for[ * ].

 

E-2

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

 

Schedule F

[ * ]for [ * ]

 

Initial[ * ]:

 

Goal:  Develop a [ * ] for [ * ] of [ * ] that can be [ * ] to [ * ] of [ * ] in
the [ * ]of [ * ] to [ * ] to [ * ] for [ * ] and[ * ].[ * ] to be at a [ * ] of
[ * ]to[ * ].

Strategy: [ * ] and [ * ] will be based on the [ * ] developed during [ * ] and[
* ], with [ * ] in [ * ] to take account of increasing [ * ] as well as[ * ]. No
[ * ] to the [ * ] (eg., [ * ]) are envisaged during this[ * ].

 

[ * ]and

[ * ]                  [ * ]             ([ * ])

                                                        [[ * ]]

 

[ * ]of[ * ]   f[ * ]or [ * ]based on[ * ].

 

[ * ]                  [ * ];

                                                        [ * ]to be[ * ].

                                                        [ * ]for [ * ]([ * ])

 

[ * ]                  [ * ].[ * ]to[ * ].[ * ]any [ * ]and [ * ]for[ * ].

 

[ * ]or[ * ]   [ * ]at[ * ]                     [ * ]for [ * ]work

 

[ * ]                  [ * ].[ * ]to[ * ].[ * ]any [ * ]and [ * ]for[ * ].

 

[ * ]                  [ * ]at [ * ]

                                                        [ * ]

 

[ * ]to

[ * ]                  [ * ]at [ * ]

 

[ * ]                                  [ * ]to[ * ].[ * ]any [ * ]and [ * ]for[
* ].

 

[ * ]to

[ * ]                  [ * ]at [ * ]

 

[ * ]                                  [ * ]to[ * ].[ * ]any [ * ]and [ * ]for[
* ].

 

[ * ]                                            [ * ]at [ * ]

 

ASSUMPTIONS:

(a)               [ * ]will [ * ]of [ * ]for [ * ]([ * ]of [ * ]may be [ * ]for[
* ]),[ * ]at [ * ]to [ * ]are similar to those obtained at[ * ].

(b)              [ * ]is[ * ].

 

F-1

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

 

(c)               The [ * ] are for [ * ] of[ * ], and do not include[ * ].

(d)              [ * ]that [ * ]and [ * ]are [ * ]and [ * ]in a[ * ].

 

 

F-2

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

 

Plan for the [ * ] of [ * ] and [ * ]

 

[ * ]of [ * ]for [ * ]and [ * ]

 

[ * ]from[ * ].[ * ]to [ * ] a [ * ] with[ * ].

 

[ * ]for[ * ]:

 

[ * ]under way[ * ], at[ * ].  This is an [ * ]to [ * ]a [ * ]for[ * ]. 
However, an [ * ] was [ * ] for [ * ] of [ * ] for [ * ]

 

[ * ]selected for [ * ] in[ * ].

 

[ * ]using the[ * ], including [ * ] was [ * ] in[ * ], at[ * ].   Certain
aspects of this [ * ] are also [ * ] at [ * ] with the[ * ].

 

[ * ]of[ * ]:   [ * ]of [ * ]to[ * ].

 

[ * ]to[ * ]:  [ * ]for[ * ].

 

[ * ]:                   [ * ]from [ * ]to[ * ].

 

[ * ]:  [ * ]of [ * ]from [ * ]at[ * ].

 

[ * ]:   [ * ]of [ * ] for[ * ].

 

[ * ]to[ * ]:[ * ] in[ * ].

 

[ * ]                    [ * ]begins to [ * ] from[ * ].

 

After the [ * ] is[ * ],[ * ] will continue in the area of [ * ] as well as [ *
] and [ * ]of[ * ].

 

F-3

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

 

 [ * ]for [ * ]

 

[ * ]:[ * ] that [ * ] is [ * ] to [ * ] of [ * ] for[ * ].[ * ] that [ * ]is [
* ]of[ * ].  Some [ * ] in [ * ] may [ * ] the [ * ]

 

[ * ]in the [ * ] of[ * ]:[ * ] from [ * ] at [ * ] on a [ * ] of[ * ].

 

[ * ]from [ * ] from the [ * ] of [ * ] will be [ * ] to [ * ] to [ * ] for [ *
] of [ * ]

 

[ * ]in[ * ]:[ * ] obtained from [ * ] from the [ * ] is used in the [ * ] of[ *
].  May require[ * ], as appropriate.

 

 

F-4

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

 

Schedule G

CLINICAL SUPPLY AGREEMENT

 

This CLINICAL SUPPLY AGREEMENT (this “Agreement”) is entered into as of November
27, 2001 (the “Effective Date”) by and between ImmunoGen, Inc., a Massachusetts
corporation having its principal office at 128 Sidney Street, Cambridge,
Massachusetts 02139, USA (“ImmunoGen”), and Boehringer Ingelheim Pharma KG, a
company organized under the laws of Germany having its principal office at
Binger Strasse 173, 55218 Ingelheim am Rhein, Germany (“BI Pharma”). ImmunoGen
and BI Pharma are sometimes referred to individually herein as a “Party” and
collectively as the “Parties.”

 

WHEREAS, Boehringer Ingelheim International GmbH at Binger Strasse 173, 55218
Ingelheim am Rhein, Germany (“BI”) and ImmunoGen have contemporaneously entered
into a Development and License Agreement as of the Effective Date (the “License
Agreement”), and BI Pharma is an Affiliate of BI; and

 

WHEREAS, the License Agreement provides the basis for the manufacture and supply
of Drug Substance for non-clinical use to BI or as directed by BI under the
License Agreement and, moreover, states that ImmunoGen and BI Pharma shall enter
or have entered into contemporaneously a supply agreement for the manufacture
and supply of Drug Product for clinical use (this “Agreement”) attached to that
License Agreement as Schedule G; and

 

WHEREAS, the Parties are in agreement that the definitions used in the License
Agreement and this Agreement shall have the same meaning, force and effect,
unless expressly otherwise provided for in this Agreement; and

 

WHEREAS, ImmunoGen has agreed to supply BI Pharma or as directed by BI Pharma
with such quantities of Drug Product as BI Pharma may reasonably request subject
to the terms and conditions set forth herein;

 

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

 

1.              DEFINITIONS

 

Whenever used in this Agreement with an initial capital letter, the respective
terms shall have the meanings used in the License Agreement and shall be
incorporated by reference herein and the terms defined in this Section 1 shall
have the meanings specified hereinafter.

 

1.1           “BIWA4” means unconjugated BIWA4 monoclonal antibody.

 

1.2           “Drug Substance Batch” means a specific quantity of the Drug
Substance that is intended to be of uniform character and quality and is
produced during the same Batch Run.

 

 

G-1

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

 

1.3           “Drug Product Batch” means a specific quantity of the Drug Product
that is intended to be of uniform character and quality and is produced during
the same aseptic filling campaign.

 

1.4           “Batch Run” shall mean the production and purification process
performed by ImmunoGen to generate a Batch of Drug Substance pursuant to this
Agreement.

 

1.5           “Calendar Quarter” means each period of three consecutive calendar
months ending on March 31, June 30, September 30 or December 31.

 

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

 

1.7           “Certificate of Analysis” means a document, signed by an
authorized representative of ImmunoGen, describing specifications for, and
testing methods applied to Drug Product or Drug Substance, and the results
thereof. A template of the Certificate of Analysis is attached hereto as
Schedule I.

 

1.8           “[   *   ]” shall mean with respect to any Drug Product or Drug
Substance, the [   *   ] of producing (including the [   *   ] and [   *   ] of
such Drug Product or Drug Substance, including the [   *   ] of the [   *   ] :
(a) the [   *   ] , including [   *   ] and [   *   ] , of [   *   ] and
[   *   ] such Drug Product or Drug Substance; (b) all[   *   ] incurred by
ImmunoGen attributable to the [   *   ] under the foregoing clause (a),
including [   *   ] and [   *   ] which are [   *   ] to [   *   ] or [   *   ]
or another [   *   ] ; (c) any other [   *   ] borne by ImmunoGen for the
[   *   ] and/or [   *   ] of Drug Product or Drug Substance; and (d) [   *   ]
and [   *   ] which are [   *   ] to [   *   ] or [   *   ] or another [   *   ]
. [   *   ]  shall the [   *   ] to [   *   ] .  Notwithstanding the foregoing,
[   *   ] of Drug Product or Drug Substance [   *   ] (i) the [   *   ] of
[   *   ] any [   *   ] to the extent [   *   ] by BI Pharma pursuant to Section
[   *   ] of this Agreement, (ii) the [   *   ] of [   *   ] other than pursuant
to Section [   *   ] of this Agreement, (iii) the [   *   ] of [   *   ] at
[   *   ] pursuant to Section [   *   ]  of this Agreement, or (iv) any
[   *   ] to [   *   ] for [   *   ] in the Facility. If [   *   ] as the case
may be can [   *   ] to [   *   ] that [   *   ] or [   *   ] used for the
[   *   ] of [   *   ] and/or [   *   ] of the [   *   ] and [   *   ] can be
[   *   ] at a [   *   ] than [   *   ] and [   *   ] or [   *   ] , or that
[   *   ] can be [   *   ] on a [   *   ] and [   *   ] , then [   *   ] shall
[   *   ] such [   *   ] for the [   *   ] of the[   *   ].

 

1.9           “Draft Specifications” means the preliminary written
specifications established for the characteristics, and quality as well as
quality control testing procedures for Drug Product or Drug Substance as the
case may be, as developed and mutually approved by the Parties in accordance
with the License Agreement, and attached hereto as Schedule A.  Draft
Specifications shall dictate the manufacture of Drug Product until such time as
the Final Specifications (as hereinafter defined) are agreed to by the Parties
in accordance with Section 3.2.

 

1.10         “Drug Product” means Drug Substance, manufactured under cGMP in the
final concentration for clinical use, aseptically filled in unlabeled, primary
packaging material.

 

1.11         “Drug Substance” means bulk BIWI1 as defined in the License
Agreement.

 

 

G-2

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

 

1.12         “Dedicated Equipment” means any equipment or machinery exclusively
used by ImmunoGen in the manufacturing of Drug Substance.

 

1.13         “Facility” means ImmunoGen’s manufacturing facility used for
manufacture of Drug Substance located at 333 Providence Highway, Norwood,
Massachusetts USA 02062 and all equipment contained therein.

 

1.14         “Good Manufacturing Practices” or “cGMP” means the current good
manufacturing practices applicable to the manufacturing of a Drug Product under
Title 21 of the United States Code of Federal Regulations as amended from time
to time.

 

1.15         “Final Specifications” means the final written specifications
established for the characteristics, quality and quality control testing
procedures for Drug Substance or Drug Product, as developed and approved by the
Parties in accordance with Section 3.2 of this Agreement.

 

1.16         “Manufacturing Process” means any and all processes (or a singular
step in any process) used or planned to be used by ImmunoGen for the
manufacturing of Drug Substance and Drug Product as described in Master Batch
Records.

 

1.17         “Manufacturing Documentation” shall mean all executed batch records
and all deviation reports and investigation reports associated with each
individual Batch Run.

 

1.18         “Master Batch Record” means a written description of the
Manufacturing Process for Drug Substance or Drug Product, which shall be
approved by BI Pharma prior to start of production of the first cGMP Drug
Substance or Drug Product Batch. All such batch records shall include all
technical requirements and specifications with regard to the manufacturing
methods, packaging process, and storage methods and procedures, as applicable.

 

1.19         “[   *   ]” means any [   *   ] or [   *   ] to [   *   ] on
[   *   ] of [   *   ] in order to perform the [   *   ] or any [   *   ] for
Drug Substance or Drug Product.

 

1.20         “Transfer Price” shall mean the price of any Drug Product to be
invoiced by ImmunoGen and payable by BI Pharma upon delivery of such Drug
Product to BI Pharma, which shall be determined in accordance with Section 7.1
hereof.

 

1.21         “Other Definitions” shall have the meaning as defined in the
respective Sections enumerated below.

 

“Shipment Order”, see Section 3.4

 

“[   *   ] “, see Section [   *   ]

 

“Drug Product Forecast”, see Section 4.2

 

“Purchase Order”, see Section 4.3

 

“Laboratory”, see Section 6.1.3

 

 

G-3

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

 

“Review”, see Section 6.1.2

 

“[   *   ] ”, see Section [   *   ]

 

“Term”, see Section 9.1

 

“Event of Default”, see Section 9.3

 

“Competent Authority”, see Section 11.3

 

“Indemnitor”, see Section 12.1.3

 

“Indemnitee”, see Section 12.1.3

 

2.             SCOPE OF AGREEMENT

 

2.1           Scope. Any reference to a defined term or concept, including but
not limited to those relating to the supply of Drug Product, financial terms,
intellectual property, indemnification, termination or governance, not
specifically contained in or otherwise addressed by this Agreement shall be
governed by the terms and conditions as set forth in the License Agreement and,
as such, any and all terms and conditions of the License Agreement shall be
incorporated by reference herein.

 

2.2           Objective. The overall objective of this Agreement is to govern
the terms and conditions pursuant to which ImmunoGen will produce for (or will
have produced for as permitted herein) and supply to BI Pharma or as directed by
BI Pharma, Drug Product for Phase I and non-pivotal Phase IIa human clinical
trials.  The production and supply of Drug Substance for non-clinical use is
governed by the License Agreement.

 

3.             SUPPLY AND SPECIFICATIONS

 

3.1           Supply. ImmunoGen is obliged to supply BI Pharma with certain
quantities of Drug Product in order for BI Pharma to conduct Phase I Trials and
non-pivotal Phase IIa Trials. The [   *   ] of [   *   ] to be [   *   ] to
[   *   ] by [   *   ] in each respective [   *   ] during the [   *   ] of this
[   *   ] is attached hereto as Schedule [   *   ]. It is the understanding of
ImmunoGen and BI Pharma that ImmunoGen shall not be obliged to supply BI Pharma
with quantities [   *   ] of the [   *   ] of [   *   ] in each [   *   ] as
listed in Schedule [   *   ] attached to this Agreement, provided that ImmunoGen
[   *   ] to [   *   ].  ImmunoGen shall produce Drug Product in a series of
Batch Runs, the exact number and size of which shall be determined by
[   *   ].  The Parties acknowledge that the number, size and/or yield of Batch
Runs are subject to change due to numerous factors, including but not limited to
production and purification processes, recruitment of patients to clinical
trials and the number of and dosing schedules chosen for human clinical trials.

 

 

G-4

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

 

3.2           Drug Substance and Drug Product Specifications. Draft
Specifications for Drug Substance and Drug Product as provided by BI Pharma are
attached hereto as Schedule A. The Parties acknowledge that these Draft
Specifications are subject to change with the collection of Batch Run
manufacturing data. Final Specifications have to be defined mutually by the
Parties prior to manufacture of the first clinical batch. ImmunoGen shall not
make any changes to the Final Specifications and the Master Batch Records,
without the prior written permission of BI Pharma; [   *   ] that [   *   ] has
[   *   ] , [   *   ] be [   *   ] for the [   *   ] of such [   *   ] and for
[   *   ] for [   *   ] or [   *   ] arising therefrom.  Upon the determination
of the Final Specifications, the Draft Specifications will no longer be
applicable to the manufacture of Drug Substance and Drug Product and shall be
replaced in full by the terms of the Final Specifications.

 

3.3           Manufacturing Process and Master Batch Records. ImmunoGen will
provide BI Pharma with Master Batch Records describing the Manufacturing Process
for Drug Product as well as for Drug Substance. ImmunoGen shall supply BI Pharma
with all required written information, including but not limited to standard
operating procedures, describing quality control procedures for testing of Drug
Substance and Drug Product.  The Master Batch Records will be agreed upon by the
Parties prior to manufacturing of the first cGMP batch. Any change to the Master
Batch Records requires prior written approval by BI Pharma. ImmunoGen will
provide copies of all Manufacturing Documentation to BI Pharma.

 

3.4           Provision of BIWA4. BI Pharma shall deliver the necessary
quantities of BIWA4, at BI Pharma’s sole cost, for a Batch Run no less than
[   *   ] days prior to the scheduled initiation of the Batch Run. The Parties
acknowledge that the necessary quantity of BIWA4 is subject to change and is
dependent on the number, size and/or yield of Batch Runs. ImmunoGen shall not be
responsible for any delay caused by BI Pharma’s failure to deliver such BIWA4 as
contemplated by this Section 3.4. BI Pharma shall provide or arrange to provide
ImmunoGen free of charge with such quantities of BIWA4 as shall be necessary
according to the Master Batch Records for the manufacture of Drug Product for BI
Pharma. ImmunoGen shall use the BIWA4 exclusively for the manufacturing of Drug
Product for BI Pharma. ImmunoGen shall store BIWA4 in controlled areas and in
accordance with the conditions specified by BI Pharma.  ImmunoGen shall issue a
written request for BIWA4 to BI Pharma (a “Shipment Order”) including, but not
limited to, amount and delivery date not later than [   *   ] prior to the
scheduled initiation of the Batch Run.

 

3.5           Excipients and Other Components. ImmunoGen shall purchase at
[   *   ] all excipients (pharmacopoeial grade), and other items of any nature
whatsoever that ImmunoGen may use or have used in manufacturing the Drug
Product, other than BIWA4. [   *   ] the [   *   ] for ensuring that all
[   *   ] used in the manufacture of Drug Product, comply with the Draft
Specifications and Final Specifications and all applicable laws and regulations.
ImmunoGen shall test and release all materials for identity and quality in
accordance with the Draft Specifications and Final Specifications prior to using
the same. All right, title and interest in and to such items, and in and to all
work-in-process incorporating such items, shall remain the sole property of
ImmunoGen.

 

 

G-5

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

 

3.6           [   *   ] has [   *   ] into [   *   ] for the [   *   ] of
[   *   ] and [   *   ] (“[   *   ] ”) and [   *   ] , to [   *   ] of its
[   *   ] , that the [   *   ] of [   *   ] and [   *   ] under the [   *   ] ,
as in effect on the Effective Date, is [   *   ] to [   *   ] for [   *   ]
under Section [   *   ] of the Supply Agreement.  A list of the [   *   ] is
attached hereto as Schedule [   *   ].

 

4.             FORECASTS AND PURCHASE ORDERS

 

4.1           Initial Supply Forecast. The minimum quantities of clinical Drug
Product to be supplied to BI Pharma by ImmunoGen during the Term of this
Agreement is attached as an initial non-binding forecast for Drug Product in
Schedule [   *   ] (provision of clinical Drug Product). In Schedule[   *   ]
the [   *   ] of [   *   ] that [   *   ] to [   *   ] from [   *   ] based upon
[   *   ] is listed beginning with the first Calendar Year after the Effective
Date.

 

4.2           Drug Product Forecasts. BI Pharma shall use its best efforts to
submit to ImmunoGen within thirty (30) days of the Effective Date and thereafter
at least three (3) calendar months prior to the start of each Calendar Quarter,
a rolling written forecast of the quantities of Drug Product estimated to be
required for the following four Calendar Quarters (“Drug Product Forecast”). In
the Drug Product Forecast, BI Pharma shall include a breakdown of the total
quantity of Drug Product by Calendar Quarters. The Parties acknowledge that
factors including, but not limited to, number of human clinical studies
conducted, clinical study enrollment and stability of Drug Product might affect
the accuracy of such Drug Product Forecasts. [   *   ] will [   *   ] from time
to time the [   *   ] so as to [   *   ] for such [   *   ].

 

4.3           Delivery of Purchase Order; Contents. Together with each Drug
Product Forecast, BI Pharma shall deliver to ImmunoGen, in writing, a binding
purchase order (“Purchase Order”) for Drug Product for the [   *   ] Subsequent
Purchase Orders shall equal the Drug Product Forecast for the [   *   ] of the
accompanying forecast. Each Purchase Order shall specify: (i) the total quantity
of Drug Product; (ii) a reference to the actual Final Specification and the
Master Batch Records; (iii) the requested location for delivery; (iv) time of
delivery; and (v) the carrier and/or manner of shipment that ImmunoGen should
use in delivering the Drug Product.

 

4.4           Governing Terms. For ordering, the [   *   ] shall use [   *   ]
(see Schedule [   *   ] [   *   ]:), however all orders shall be subject to the
provisions of this Agreement and shall not be subject to any inconsistent terms
and conditions contained on any Purchase Order or Shipment Order, except insofar
as any such document or request establishes: (a) the quantity of Drug Product to
be shipped; (b) the delivery date; (c) the requested location for delivery; or
(d) the carrier and/or manner of shipment.

 

4.5           [   *   ] for [   *   ] to [   *   ].  In the event that, over a
given [   *   ], [   *   ] to [   *   ] with at [   *   ] of the [   *   ] of
[   *   ] specified in the [   *   ] for that [   *   ] or the [   *   ] of
[   *   ] specified in Schedule [   *   ] for that [   *   ] and [   *   ] is
not [   *   ] to a [   *   ] set forth in Section [   *   ] or to a [   *   ] by
[   *   ] or [   *   ] of this Agreement, then, subject to the [   *   ] of
[   *   ] Section [   *   ] under the [   *   ] as follows.  If [   *   ] to
[   *   ] of [   *   ], then [   *   ] the [   *   ] and [   *   ] pursuant to
Section [   *   ] of the [   *   ].  If [   *   ] to [   *   ] of [   *   ],
then [   *   ] the [   *   ] and [   *   ] pursuant to Section [   *   ] of
the[   *   ].  The foregoing notwithstanding, [   *   ] the [   *   ] of the
[   *   ] to [   *   ] such [   *   ] and [   *   ].

 

 

 

G-6

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

 

4.6           Notices.  All notices to ImmunoGen under this Section 4 shall be
delivered to ImmunoGen to the attention of [   *   ] at 128 Sidney Street,
Cambridge, Massachusetts USA 02139 or to such other person and location as
ImmunoGen may specify to BI Pharma in writing from time to time.

 

5.             PRODUCTION

 

5.1           Batch Runs. All production and supply by ImmunoGen of Drug Product
under this Agreement shall be denominated in terms of Batch Runs. ImmunoGen will
review each Drug Product Forecast and determine [   *   ] the exact number and
size of the Batch Runs necessary to fulfill each Purchase Order. The Parties
acknowledge that the number, size and/or yield of Batch Runs are subject to
change due to numerous factors, including but not limited to production and
purification processes. [   *   ] to [   *   ] and [   *   ] the [   *   ]
for[   *   ] to [   *   ] for [   *   ] of [   *   ] (for details, see [   *   ]
Section [   *   ] ).  The Parties agree that all changes to the Manufacturing
Process are subject to a change control procedure and have to be finally agreed
upon by BI Pharma. ImmunoGen shall complete in accordance with the requirements
of cGMP a Manufacturing Documentation and a Certificate of Analysis for every
Drug Substance Batch and Drug Product Batch. ImmunoGen shall provide copies of
this documentation and shall maintain all documentation pertaining to the Drug
Product for at least [   *   ] of the date of final release by BI Pharma of the
Drug Product.

 

5.2           Specifications. All Drug Product supplied to BI Pharma hereunder
(i) will comply with all applicable Draft Specifications or Final Specifications
at the time of manufacture and (ii) will have been manufactured in accordance
with the Master Batch Records and cGMP.

 

5.3           Facility. ImmunoGen shall conduct all manufacturing of the Drug
Substance at the Facility and shall maintain at the Facility all equipment,
Dedicated Equipment, components and other items used to manufacture Drug
Substance. ImmunoGen (i) shall notify BI Pharma in writing, not less than
[   *   ] prior to any proposed, foreseeable change in the location or status of
the Facility and (ii) shall notify BI Pharma in writing as soon as possible of
any unforeseeable change in the location or status of the Facility and (iii)
shall be responsible for obtaining, at its own expense, any necessary regulatory
approvals in connection with any such change and BI Pharma’s agreement thereto.
[   *   ] to [   *   ] with the [   *   ] to [   *   ] at the Facility. Any
[   *   ] in the [   *   ] of the [   *   ] , which shall not be unreasonably
withheld.

 

5.4           [   *   ].  Notwithstanding the following provision, [   *   ]
shall not be allowed to [   *   ] any [   *   ] in the [   *   ] and [   *   ]
of the [   *   ] the [   *   ] of [   *   ]. The [   *   ] of [   *   ] is
attached hereto as Schedule [   *   ].  [   *   ] and [   *   ] of [   *   ] of
[   *   ].  [   *   ] (i) shall notify [   *   ] in writing, not less than
[   *   ] prior to any [   *   ] in the [   *   ] and (ii) shall notify
[   *   ] in writing as soon as possible of any [   *   ] in the [   *   ]. 
However, in the case of a [   *   ] in [   *   ], [   *   ] of [   *   ] or
[   *   ] of [   *   ] shall require the [   *   ] of [   *   ].  [   *   ]
hereby [   *   ] that [   *   ] has the [   *   ] to [   *   ] each of
[   *   ], to be [   *   ], if feasible, and that the [   *   ] is [   *   ] to
[   *   ] into a [   *   ].

 

 

G-7

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

 

5.5           Dedicated Equipment. ImmunoGen shall supply, at its own expense,
all equipment required for the purpose of manufacturing the Drug Substance.
Notwithstanding the foregoing, if during the Term of this Agreement, [   *   ]
determine in [   *   ] that it is necessary or advisable to purchase Dedicated
Equipment for ImmunoGen to perform any of its obligations to manufacture Drug
Substance under this Agreement, then ImmunoGen shall [   *   ] of [   *   ],
along with the [   *   ] for such [   *   ] and [   *   ] for such Dedicated
Equipment, in order to achieve BI Pharma’s written approval of the same.
[   *   ] shall evaluate [   *   ] the [   *   ] of such Dedicated Equipment to
[   *   ] to be [   *   ] for such [   *   ] is [   *   ] to [   *   ] and
whether such [   *   ] at a [   *   ].  [   *   ]shall provide [   *   ] with a
[   *   ] of [   *   ] to [   *   ] of [   *   ], which will be necessary during
the production of Drug Product (see Schedule [   *   ]). Subject to the
foregoing, promptly after the consummation of such purchase on behalf of BI
Pharma, ImmunoGen shall provide BI Pharma with a copy of the invoice or invoices
reflecting such purchase(s), and BI Pharma shall reimburse ImmunoGen for the
purchase of all such agreed Dedicated Equipment hereunder within [   *   ] of
its receipt of such invoices from ImmunoGen. All such Dedicated Equipment shall
be owned by BI Pharma, shall be maintained, decontaminated and cleaned by
ImmunoGen as long as ImmunoGen has possession thereof, and shall be used by
ImmunoGen solely for the benefit of BI Pharma. The Parties hereby agree that any
costs that are incurred by ImmunoGen and are reimbursed by BI Pharma under this
Section 5.5 shall not be included within the [   *   ] of any [   *   ] under
this Agreement. Upon any termination of this Agreement, ImmunoGen shall permit
BI Pharma to remove all such Dedicated Equipment from its Facility at BI
Pharma’s sole cost and expense, provided, that any reimbursement due by BI
Pharma for such Dedicated Equipment has been fully paid to ImmunoGen.

 

5.6           Maintenance of Facility. ImmunoGen shall maintain, at its own
expense, the Facility, (including, without limitation the equipment and the
Dedicated Equipment) in a state of repair, cleanliness and operating efficiency
consistent with the requirements of the Draft Specifications and Final
Specifications respectively, cGMP and other applicable requirements.

 

6.             DELIVERY, TESTING AND ACCEPTANCE

 

6.1           Pre-Delivery Testing.

 

6.1.1.          ImmunoGen Responsibilities. Prior to delivery to BI Pharma,
ImmunoGen shall test, or cause to be tested, a representative sample of each
Drug Product Batch (or components as applicable) to demonstrate that such Drug
Product Batch complies with the applicable specifications (manufacturer’s
release). For each Drug Product Batch to be delivered to BI Pharma or to a
recipient designated by BI Pharma, ImmunoGen shall prepare and submit a
representative sample of such Drug Product Batch, and a Certificate of Analysis
that identifies the items tested, the applicable specifications and test
results. The present format and required content of the Certificate of Analysis
is attached hereto as Schedule I. Any changes thereto shall be agreed upon by
the Parties. ImmunoGen will also submit a copy of the Manufacturing
Documentation. ImmunoGen shall provide raw data upon reasonable request by BI
Pharma.

 

 

G-8

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

 

6.1.2.          BI Pharma Responsibilities. Prior to delivery to BI Pharma, BI
Pharma shall determine whether the Drug Product conforms to applicable
specifications for use in human clinical trials (the “Review”). BI Pharma may
conduct a Review by: (i) reviewing the Certificate of Analysis and the
Manufacturing Documentation and such other documents, if any, as BI Pharma may
request; and (ii) conducting acceptance testing of a representative sample of
the Drug Product Batch. BI Pharma shall conduct its Review within [   *   ] of
the receipt of a representative sample of the Drug Product Batch including
Manufacturing Documentation of Drug Substance, [   *   ] that [   *   ] have a
[   *   ] of [   *   ] for [   *   ] after [   *   ] of [   *   ] and [   *   ]
after [   *   ] of [   *   ] the [   *   ].

 

6.1.3.          Specification Dispute Resolution. In case of any disagreement
between the Parties as to whether a Drug Product conformed with applicable Draft
Specifications or Final Specifications, a representative sample of the disputed
Drug Product shall be submitted for tests and final determination of whether the
Drug Product conformed with such applicable specifications to an independent
testing organization mutually agreed upon by the Parties (the “Laboratory”). 
The Laboratory must meet current Good Laboratory Practices as defined by the FDA
from time to time, and the appointment of such Laboratory shall not be
unreasonably withheld or delayed by either Party. Such Laboratory shall use the
test methods contained in the applicable specifications. The determination of
such Laboratory with respect to all or part of the Drug Product shall be final
and binding on the Parties.  The fees and expenses of the Laboratory incurred in
making such determination shall be paid by the Party against whom the
determination is made.

 

6.2           Notification. Within [   *   ] of the completion of the Review, BI
Pharma shall notify ImmunoGen in writing whether the Drug Product conforms to
Final Specifications.

 

6.3           [   *   ]; Inspection and Rejection; Shortages. In the event that
any Drug Product Batch after [   *   ] to BI Pharma is [   *   ] to [   *   ] to
[   *   ] with the [   *   ], ImmunoGen shall, [   *   ] (a) [   *   ] of such
Drug Product to BI Pharma or [   *   ] the [   *   ], as the case may be,
[   *   ]; or (b) if [   *   ] is not possible [   *   ], at [   *   ], either
[   *   ] or [   *   ] for the [   *   ] for such Drug Product. ImmunoGen may
[   *   ] any Drug Product [   *   ] for [   *   ].  The foregoing does not
apply if the [   *   ] of the [   *   ] is [   *   ] the [   *   ] of
ImmunoGen.  [   *   ], the [   *   ] only if [   *   ] is [   *   ] to the
[   *   ] of the [   *   ].  [   *   ] shall [   *   ] the [   *   ] and
[   *   ] for the [   *   ] of [   *   ] to [   *   ] as the [   *   ] over
[   *   ] from [   *   ] with the [   *   ].  Any dispute regarding [   *   ]
under [   *   ] Section [   *   ] shall be resolved in the same manner as
provided for in Section [   *   ]

 

6.4           Failed Batches. ImmunoGen shall bear the responsibility for a
failed Batch Run if such failure is attributable to the [   *   ] or [   *   ]
of ImmunoGen.  The foregoing notwithstanding, the [   *   ] that there may be
[   *   ] not [   *   ] to [   *   ] . [   *   ] of [   *   ] shall take place
according to the [   *   ] in [   *   ], in which the [   *   ] to the [   *   ]
of [   *   ].

 

6.5           Shipment. Upon receipt of written notice from BI Pharma, ImmunoGen
shall deliver to BI Pharma or as directed by BI Pharma the respective Drug
Product on the date provided for in the respective Purchase Order.  Drug Product
delivered pursuant to the terms of this Agreement shall be suitably packed and
marked for shipment according to BI Pharma’s Purchase Order. Delivery terms
shall be DDP location in EU as determined by BI Pharma in the respective
Purchase Order or CIP Ridgefield (INCO terms 2000) at BI Pharma’s option.
[   *   ] to the[   *   ] be [   *   ] to [   *   ] upon [   *   ] of
[   *   ].  The Parties shall agree on a preferred carrier, packaging material,
and detailed insurance conditions. 

 

 

G-9

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

 

6.6           Final Release. BI Pharma shall be responsible for the release of
Drug Product for use in clinical trials (final release).

 

6.7           Notices.  All notices to ImmunoGen under this Section 6 shall be
delivered to ImmunoGen to the attention of [   *   ] at 333 Providence Highway,
Norwood, Massachusetts USA 02062 or to such other person and location as
ImmunoGen may specify to BI Pharma in writing from time to time.

 

6.8           [   *   ].  In an effort to [   *   ] the [   *   ] of [   *   ]
the [   *   ] of [   *   ] by the [   *   ] of [   *   ] , [   *   ] and
[   *   ] hereby agree to use [   *   ] during the [   *   ] of this [   *   ]
to [   *   ] and [   *   ] an [   *   ] of [   *   ] of the [   *   ] to
[   *   ] the [   *   ] listed on Schedule [   *   ] of the[   *   ], as it
becomes [   *   ] and to the extent it is [   *   ] or [   *   ] and [   *   ]
and [   *   ].  In connection therewith, ImmunoGen shall provide [   *   ] to BI
of the [   *   ] of [   *   ] and the [   *   ] as well as the other [   *   ]
(if any) of such [   *   ] and [   *   ] to [   *   ] to [   *   ] .  Subject to
the foregoing, all [   *   ] associated with [   *   ] the [   *   ] of
[   *   ] shall be borne by [   *   ].  Upon any termination of this Agreement,
[   *   ] shall [   *   ] to [   *   ] all such [   *   ] from its [   *   ] at
sole cost and expense, provided, that any [   *   ] due by [   *   ] [   *   ]
for such [   *   ] has been fully paid to [   *   ].

 

7.             PRICE AND PAYMENT

 

7.1           Transfer Price for Product. All Drug Product supplied to BI Pharma
or a third party designated by BI Pharma under this Agreement shall be supplied
to BI Pharma at a Transfer Price equal to [   *   ] of ImmunoGen’s [   *   ] of
such [   *   ] in accordance with Section [   *   ] hereof.

 

7.2           Invoicing and Timing. The payment will be made [   *   ] upon
written notice of [   *   ] of the [   *   ] by [   *   ] and after [   *   ] by
[   *   ] of the [   *   ], [   *   ] if any.  The [   *   ] or [   *   ] shall
[   *   ] the [   *   ] of [   *   ] as described in Schedule [   *   ] . In
case of [   *   ] that [   *   ] is [   *   ] to [   *   ] for pursuant to
Schedule [   *   ], [   *   ] shall be made within [   *   ] of receipt of such
invoice.  Any invoices which remain unpaid more than [   *   ] beyond the
scheduled payment due date may be subjected to an interest charge at a rate of
[   *   ].

 

7.3           Notices.  All notices to BI Pharma under this Section 7 shall be
delivered to BI Pharma to the attention of Grp.Contr.F+E+M Pharma D, att.:
[   *   ] at Birkendorfer Str. 65, 88397 Biberach, Germany, or to such other
person and location as BI Pharma may specify to ImmunoGen in writing from time
to time.

 

 

G-10

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

 

8.             TITLE AND AUDIT RIGHTS

 

8.1           BI Pharma Audit Rights.

 

8.1.1.          Audit of Facility. ImmunoGen agrees that BI Pharma and its
agents shall have the right, upon reasonable prior notice to ImmunoGen, to
inspect the Facility and audit ImmunoGen’s quality control system and [   *   ]
during normal business hours in order to ascertain compliance by ImmunoGen with
the terms of this Agreement, including, but not limited to, inspection of (a)
the materials used in the manufacture of the Drug Product, (b) the holding
facilities for such materials, (c) the equipment used to manufacture the Drug
Product, (d) the quality control procedures and (e) all records relating to such
manufacturing, quality control and Facility. Any information disclosed in
writing, orally or by inspection of tangible objects shall be considered
ImmunoGen’s Confidential Information and protected as such by BI Pharma and its
agents pursuant to the terms of the License Agreement. [   *   ] agrees to
[   *   ] and [   *   ] of [   *   ] of [   *   ] and [   *   ] a [   *   ] to
the [   *   ].

 

8.1.2.          [   *   ] of [   *   ].  [   *   ] shall [   *   ] can be
[   *   ] by [   *   ] for [   *   ] in the same manner as described in Section
[   *   ].

 

8.1.3.          Audit of Total Cost. ImmunoGen shall keep complete and accurate
records of its Total Cost of Drug Product supplied under this Agreement in
sufficient detail to allow such Total Cost to be determined accurately. BI
Pharma shall have the right, during the Term of this Agreement [   *   ], to
appoint an independent certified public accountant reasonably acceptable to
ImmunoGen to inspect the relevant records of ImmunoGen to verify its statements
of Total Cost of Drug Product. ImmunoGen shall make its records available for
inspection by such independent certified public accountant during regular
business hours at such place or places where such records are customarily kept,
upon reasonable notice from BI Pharma, solely to verify the accuracy of its
statements of Total Cost of Drug Product. Such inspection right shall not be
exercised more than [   *   ] during any [   *   ] period.  BI Pharma agrees to
hold in strict confidence all information concerning ImmunoGen’s costs, and all
information learned in the course of any audit or inspection, except to the
extent necessary for BI Pharma to reveal such information in order to enforce
its rights under this Agreement or if disclosure is required by law, regulation
or judicial order. The results of each inspection, if any, shall be binding on
both Parties. BI Pharma shall pay for such inspections, except that, in the
event an inspection reveals an overcharge to BI Pharma of greater than
[   *   ], ImmunoGen shall pay for such inspection.

 

8.2           Government Inspections. ImmunoGen, in accordance with applicable
laws and regulations, shall permit representatives of any regulatory agency
having jurisdiction over the manufacture and/or marketing of the Drug Substance
or the Drug Product, including the FDA and the EMEA, but not limited to the
same, to inspect its Facility in conjunction with the manufacture, quality
control, registration, storage, handling and shipping of the Drug Product.
ImmunoGen shall promptly advise BI Pharma if ImmunoGen receives a notice of an
impending inspection or if an authorized agent of the FDA or other governmental
agency visits any of ImmunoGen’s facilities including the Facility concerning
the Drug Product. ImmunoGen shall furnish to BI Pharma non-confidential copies
of any report, including any FDA Form 483 notices (or comparable notices of
other agencies), regulatory letters or similar documents received from such
agency and the application of such report to Drug Product, if any, within
[   *   ] of ImmunoGen’s receipt of such report.

 

 

G-11

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

 

9.             TERM AND TERMINATION

 

9.1           Term. This Agreement shall become effective on the Effective Date
and shall continue in full force and effect until the earlier of the conclusion
of Phase I Trials and non-pivotal Phase IIa Trials or the termination of the
License Agreement (the “Term”).

 

9.2           Termination [   *   ].  This Agreement may be terminated [   *   ]
by [   *   ] by giving [   *   ] prior written notice to[   *   ].

 

9.3           Early Termination.Notwithstanding Section 9.1, either Party may,
in addition to exercising any other available legal or equitable rights or
remedies, terminate this Agreement, effective immediately upon the expiration of
any applicable cure period, upon the occurrence of an Event of Default (as
defined below) with respect to the other Party.  The term “Event of Default”
with respect to a Party means the occurrence of any of the following events:

 

(a)                                  The failure of a Party to comply with or
perform any material provision of this Agreement, and such failure remains
uncured for [   *   ] following written notice of such failure (if such default
is cured within the cure period, such written notice shall be null and void),
provided that, if the defaulting Party can establish to the reasonable
satisfaction of the other Party that it is diligently and actively pursuing a
cure at the expiration of the cure period, and that the default is reasonably
capable of being cured, then the cure period shall be extended for so long as a
cure is being diligently and actively pursued, not to exceed [   *   ] in the
aggregate.

 

(b)                                 A Party (i) becomes unable to pay its debts
as they mature, (ii) is the subject of a voluntary or involuntary petition in
bankruptcy or of any other proceeding under bankruptcy, insolvency or similar
laws which, if involuntary, is not dismissed within [   *   ] of the date filed,
(iii) makes an assignment for the benefit of creditors, (iv) is named in, or its
property is subject to, a suit for the appointment of a receiver which is not
dismissed within [   *   ] of the date filed, or (v) is dissolved or liquidated.

 

9.4           Effect of Termination of this Agreement. The termination of this
Agreement shall in no way affect the validity of the License Agreement.  Upon
termination, ImmunoGen shall invoice BI Pharma for all costs that are incurred
but remain unbilled as of the effective date of termination.  Payment of such
invoice shall be pursuant to the terms of Section 7.2 of this Agreement.

 

9.5           Limited Liability.  Except as otherwise provided in this
Agreement, neither ImmunoGen nor BI Pharma will be liable with respect to any
subject matter of this Agreement under any contract, negligence, strict
liability or other legal or equitable theory for any punitive damages or
indirect, incidental, consequential damages or lost profits, including, without
limitation, cost of procurement of substitute goods or technology, or loss of
opportunity, loss of income or compensation for loss of goodwill.

 

 

G-12

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

 

10.          SECRECY OBLIGATIONS

 

10.1         General Applicability of the Provisions of the License Agreement.
The Parties are in agreement that the confidentiality and secrecy obligations of
the License Agreement shall apply to this Agreement for the Term of this
Agreement and for a period of [   *   ] thereafter.

 

11.          ADDITIONAL OBLIGATIONS OF THE PARTIES

 

11.1         Laws and Regulations. The Parties agree to comply with all
applicable laws, rules, regulations or requirements in connection with the
manufacture of BIWA4, Drug Substance, and Drug Product.

 

11.2         Permits and Licenses for Facility / Regulatory Submissions.
ImmunoGen shall be responsible for obtaining, [   *   ], any Facility or other
licenses or permits, and any regulatory and government approvals necessary for
the manufacture of Drug Substance and the supply of Drug Product to BI Pharma in
accordance with the terms and conditions of this Agreement. ImmunoGen shall
provide to BI Pharma all information relevant to specific methods of Drug
Product manufacture and any other information specific to the Drug Product and
relevant to FDA and analogous non-U.S. regulatory submissions, including,
without limitation, IND, BLA and other regulatory submissions, in a timely
manner to enable punctual submission by BI Pharma of necessary regulatory
documentation.

 

11.3         Notification of Inspections; Communications. ImmunoGen shall permit
BI Pharma or its agents to be present and participate in any visit to, or
inspection of, the Facility as it pertains to Drug Substance or Drug Product or
review of the Manufacturing Process by any Competent Authorities. ImmunoGen
shall give prompt notice to BI Pharma of any such visit, inspection or review.
ImmunoGen shall promptly provide to BI Pharma all information (including copies
of any written communication) from and to Competent Authorities concerning the
Drug Substance or Drug Product, and shall use reasonable commercial efforts to
consult with BI Pharma concerning the response of ImmunoGen to each such
communication. It is understood by the Parties that all such communications fall
under the confidentiality obligations.

 

11.4         Regulatory Assistance. ImmunoGen agrees to provide to BI Pharma
such information and assistance relating to the manufacture and quality control
of the Drug Product as BI Pharma may reasonably require for purposes of applying
for and maintaining all registrations for the Drug Product including, without
limitation, providing BI Pharma with all reports, authorizations, certificates,
methodologies, and other documentation in the possession or under the control of
ImmunoGen relating to the manufacture and quality control of the Drug Product
(or any component thereof).

 

 

G-13

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

 

11.5         Debarment. ImmunoGen represents and warrants that it has not been
debarred and is not subject to a pending debarment and that it will not use in
any capacity, in connection with the services to be performed under this
Agreement, any person who has been debarred pursuant to section 306 of the
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 335a, or who is the subject of
a conviction described in such section. ImmunoGen agrees to inform BI Pharma in
writing immediately if it or any person who is performing services hereunder is
debarred or is the subject of a conviction described in section 306, or if any
action, suit, claim, investigation, or legal or administrative proceeding is
pending or, to the best of ImmunoGen’s knowledge, is threatened, relating to the
debarment or conviction of ImmunoGen or any person performing services
hereunder.

 

11.6         Compliance with U.S. Export Regulations. BI Pharma understands that
Drug Product to be purchased hereunder may require ImmunoGen to obtain a
validated export license from the United States Department of Commerce. It shall
be ImmunoGen’s task and responsibility to obtain such export license and BI
Pharma agrees to assist ImmunoGen in obtaining any such required license by
supplying appropriate documentation reasonably requested by ImmunoGen. In
connection therewith, BI Pharma agrees to comply with U.S. Export Administration
Regulations as in effect from time to time and brought to BI Pharma’s attention
by ImmunoGen. BI Pharma will also maintain all records necessary to comply with
United States Export Administration Regulations brought to BI Pharma’s attention
by ImmunoGen.

 

12.          WARRANTY /LIABILITY

 

12.1.1.     ImmunoGen Representations:  ImmunoGen represents and warrants to BI
Pharma that:

 

(a)                                  No Conflict. The execution, delivery and
performance of this Agreement by ImmunoGen does not conflict with any agreement,
instrument or understanding, oral or written, to which it is a Party or by which
it may be bound, and does not violate any law or regulation of any court,
governmental body or administrative or other agency having authority over it. 
ImmunoGen is not currently a party to, and during the term of this Agreement
will not enter into, any agreements, oral or written, that are inconsistent with
its obligations under this Agreement.

 

(b)                                 Authority. ImmunoGen is validly existing and
in good standing under the laws of the state of its incorporation and has the
corporate power and authority to enter into this Agreement. The execution,
delivery and performance of this Agreement have been duly authorized by all
necessary action on the part of ImmunoGen, its officers and directors.

 

 

G-14

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

 

(c)                                  Ownership.  To ImmunoGen’s knowledge, all
of the Licensed Patents are subsisting and are valid and enforceable. ImmunoGen
(i) has not previously assigned, transferred, conveyed or otherwise encumbered
its right, title and interest in Licensed Patents, or any component of the
Licensed Technology, and (ii) has no knowledge of the existence of any patent,
trademark or other intellectual property right (other than any patent
application) owned or Controlled by ImmunoGen, other than the Licensed Patent
Rights, in case of either (i) or (ii), that would prevent ImmunoGen and BI
Pharma from manufacturing and supplying Drug Product, and BI from exploiting its
rights granted under Section 2.1 of the License Agreement.  In addition,
ImmunoGen has no knowledge of the existence of any patent or intellectual
property right (other than any patent application) owned or Controlled by a
third party that would materially conflict with the grant of the license set
forth in Section 2.1 of the License Agreement.

 

(d)                                 Litigation. There are no claims, judgements
or settlements against, pending with respect to the Licensed Patents or any
component of Licensed Technology. In addition, to ImmunoGen’s knowledge, no such
claims, judgements or settlements are threatened.

 

(e)                                  Further Warranties:  ImmunoGen covenants to
BI Pharma that:

 

(i)                                     The development and manufacture of Drug
Substance and Drug Product by ImmunoGen under this Agreement shall be in
compliance with all applicable laws, requirements and regulations.

 

(ii)                                  All Certificates of Analysis which will be
provided to BI Pharma under this Agreement shall be generated and documented in
accordance with generally accepted standards of the pharmaceutical industry.

 

(iii)                               ImmunoGen hereby represents and warrants
that as of the Effective Date (a) ImmunoGen has [   *   ] the [   *   ] as
listed on Schedule [   *   ], and (b) each of the is in [   *   ] and [   *   ]
and constitutes a [   *   ] and [   *   ] of [   *   ].

 

12.1.2.     BI Pharma Representations and Warranties:  BI Pharma represents,
warrants and covenants to ImmunoGen that:

 

(a)                                  No Conflict. The execution, delivery and
performance of this Agreement by BI Pharma does not conflict with any agreement,
instrument or understanding, oral or written, to which it is a party or by which
it may be bound, and does not violate any law or regulation of any court,
governmental body or administrative or other agency having authority over it. 
BI Pharma is not currently a party to, and during the term of this Agreement
will not enter into, any agreements, oral or written, that are inconsistent with
its obligations under this Agreement.

 

 

G-15

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

 

(b)                                 Authority. BI Pharma is validly existing and
in good standing under the laws of the state of its incorporation and has the
corporate power and authority to enter into this Agreement. The execution,
delivery and performance of this Agreement have been duly authorized by all
necessary action on the part of BI Pharma, its officers and directors.

 

(c)                                  BIWA4.  BI Pharma’s manufacture and
delivery of BIWA4 under this Agreement shall be in compliance with the laws,
requirements and regulations applicable thereto in the Territory.

 

12.1.3.     Indemnification by the Parties: Each party (the “Indemnitor”) will
indemnify the other party (the “Indemnitee”) against any liability in connection
with any claim, suits, liabilities, etc. arising out of the performance by the
Indemnitor of its work under this Agreement or the exploitation by the
Indemnitor of its rights under this Agreement, including, without limitation,
the development and manufacture of Drug Substance and Drug Product, unless such
liability results from (i) the negligence or wilful misconduct of the Indemnitee
or (ii) a breach of the warranties set forth in this Agreement by the
Indemnitee.

 

12.1.4.     Indemnification Procedures:

 

(a)                                  The Indemnitee shall: (i) notify the
Indemnitor of any liability and full details of the basis therefor with respect
to which the Indemnitee intends to claim indemnification as soon as practicable
after the Indemnitee becomes aware of any such liability; (ii) permit the
Indemnitor to assume the defence thereof ; and (iii) cooperate with the
Indemnitor, at the Indemnitor’s expense, in the defence thereof.

 

(b)                                 With respect to any matter for which the
Indemnitor has an obligation to indemnify the Indemnitee under this Agreement,
the Indemnitee shall have the right to participate and be represented (at the
Indemnitor’s expense) by legal counsel of the Indemnitee’s choice in all
proceedings and negotiations, if representation by counsel retained by
Indemnitor would be inappropriate due to actual or potential differing interests
between the Indemnitee and any other party represented by such counsel in such
proceedings.

 

(c)                                  The indemnity agreement in this Section 12
shall not apply to amounts paid in settlement of any liability if such
settlement is effected without the consent of the Indemnitor, which consent
shall not be unreasonably withheld.

 

(d)                                 Failure of the Indemnitee to deliver notice
to the Indemnitor within [   *   ] after becoming aware of a liability shall
relieve the Indemnitor of any liability to the Indemnitee pursuant to this
Section 12 in the event, but only to the extent, such delay is prejudicial to
the Indemnitor’s ability to defend such action.

 

 

G-16

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

 

13.          MISCELLANEOUS

 

13.1         Force Majeure. The Parties shall not be liable in any respect for
failure to perform their obligations hereunder or for delay in shipment of BIWA4
or Drug Product pursuant to accepted orders where such failure or delay shall
have been due wholly or in part to the elements, acts of God, acts of civil or
military authority or terrorism, fires, floods, epidemics, quarantine
restrictions, war, riots, strikes, lock outs, break down, differences with
workmen, accidents to machinery, delays in transportation or delays in delivery
by suppliers or manufacturers beyond the Parties’ control. In event of such
force majeure, the Party affected thereby shall use reasonable efforts to cure
or overcome the same and resume performance of its obligations hereunder.

 

13.2         Other Restrictions. Both Parties will conduct business in a manner
that reflects favorably at all times on the products containing DM1, goodwill,
and reputation of the other Party. Without limiting the foregoing, neither Party
nor its Affiliates shall engage in any deceptive, misleading, illegal, unfair,
or unethical practices that are or may be detrimental to the other Party or its
Affiliates.

 

13.3         Notices. Unless otherwise and expressly required under this
Agreement, all notices shall be in writing and mailed via certified mail, return
receipt requested, courier, or facsimile transmission addressed as follows, or
to such other address as may be designated by either Party in writing to the
other Party from time to time:

 

If to ImmunoGen:

 

 

If to BI Pharma:

Attn: Chief Executive Officer

 

Attn:  Clinical Trial Supplies Unit

128 Sidney Street

 

Department of Pharmaceutical Research and Development

Cambridge, MA 02139

 

Birkendorfer Strasse 65

United States of America

 

88397 Biberach

 

 

Germany

 

13.4         Governing Law. This Agreement shall be governed [   *   ].  Where
not as otherwise provided for in this Agreement, in the event of any controversy
or claim arising out of or relating to any provision of this Agreement, the
Parties shall first try to settle those conflicts amicably between themselves.
Any dispute, controversy or claim initiated by either Party arising out of,
resulting from or relating to this Agreement, or the performance by either Party
of its obligations under this Agreement (other than bona fide third Party
actions or proceedings filed or instituted in an action or proceeding by a third
Party against a Party), whether before or after termination of this Agreement,
shall be finally resolved by binding arbitration.  Whenever a Party shall decide
to institute arbitration proceedings, it shall give written notice to that
effect to the other Party.  Any such arbitration shall be conducted under the
commercial arbitration rules of the ICC by a panel of three arbitrators
appointed in accordance with such rules.  Any such arbitration shall be held in
[   *   ].  The arbitrators shall have the authority to grant specific
performance and to allocate between the Parties the costs of arbitration in such
equitable manner as they determine.  Judgment upon the award so rendered may be
entered in any court having jurisdiction or application may be made to such
court for judicial acceptance of any award and an order of enforcement, as the
case may be.  In no event shall a demand for arbitration be made after the date
when institution of a legal or equitable proceeding based upon such claim,
dispute or other matter in question would be barred by the applicable statute of
limitations.  Notwithstanding the foregoing, either Party shall have the right,
without waiving any right or remedy available to such Party under this Agreement
or otherwise to seek and obtain from any court of jurisdiction any interim or
provisional relief that is necessary or desirable to protect the rights or
property of such Party, pending the selection of the arbitrators hereunder or
pending the arbitrators’ determination of any dispute, controversy or claim
hereunder.

 

 

G-17

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

 

13.5         Binding Effect. This Agreement shall be binding upon and inure to
the benefit of the Parties and their respective legal representatives,
successors and permitted assigns.

 

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

 

13.7         Amendment; Waiver. This Agreement may be amended, modified,
superseded or canceled, and any of the terms may be waived, only by a written
instrument executed by each Party or, in the case of waiver, by the Party or
Parties waiving compliance. The delay or failure of any Party at any time or
times to require performance of any provisions shall in no manner affect the
rights at a later time to enforce the same. No waiver by any Party of any
condition or of the breach of any term contained in this Agreement, whether by
conduct, or otherwise, in any one or more instances, shall be deemed to be, or
considered as, a further or continuing waiver of any such condition or of the
breach of such term or any other term of this Agreement.

 

13.8         Independent Contractors; No Agency or Partnership. The relationship
between ImmunoGen and BI Pharma is that of independent contractors. Nothing
contained in this Agreement shall give either Party the right to bind the other,
or be deemed to constitute the Parties as agents for the other or as partners
with each other or any third party.

 

13.9         Assignment and Successors. Either Party shall not be entitled to
assign or otherwise transfer its rights and obligations under this Agreement in
whole or in part to any third party without the prior written consent of the
other Party.

 

13.10       Integration; Severability. If any provision of this Agreement is or
becomes invalid or is ruled invalid by any court of competent jurisdiction or is
deemed unenforceable, it is the intention of the Parties that the remainder of
the Agreement shall not be affected.

 

14.          LIST OF SCHEDULES

 

Schedule A:                               [   *   ] for Drug Substance and Drug
Product as provided by BI Pharma

 

Schedule B:                                 [   *   ] Dedicated Equipment to
[   *   ] of [   *   ], which will be necessary during the production of Drug
Product (see Section 5.5)

 

 

G-18

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

 

Schedule [   *   ]:        Table of [   *   ]

 

Schedule D:                                Form of Invoice and [   *   ] of
[   *   ]

 

Schedule [   *   ]:        [   *   ]

 

Schedule F:                                  Purchase Order BI Pharma

 

Schedule G:                                 [   *   ] of [   *   ]

 

Schedule [   *   ]:        [   *   ]

 

Schedule I:                                     Templates of Certificates of
Analysis for Drug Substance and Drug Product

 

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized representatives.

 

 

IMMUNOGEN, INC.

 

 

 

 

 

 

 

 

 

By:

 

 

 

 

 

 

 

Title:

 

 

 

 

 

 

 

 

 

 

 

BOEHRINGER INGELHEIM PHARMA KG

 

 

ppa.

 

 

 

 

 

 

By:

 

 

 

 

 

 

 

 

 

 

Authorized Signatories:

 

A. Dehio

Dr. H. Michelberger

 

 

G-19

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

 

Schedule A

[   *   ]

 

 

of

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

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

1[   *   ] on the [   *   ]

 

of

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

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

1[   *   ] on the [   *   ] n

 

A-1

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

 

Schedule B

[   *   ] of [   *   ]

for [   *   ]

 

[   *   ] /[   *   ]

 

1              [   *   ] for [   *   ] and [   *   ] of [   *   ] up to
[   *   ] or [   *   ] (including [   *   ] and [   *   ] ) ([   *   ] )

 

[   *   ]

 

1                                          [   *   ] for [   *   ] and [   *   ]
of [   *   ] (including [   *   ] and [   *   ] )

 

[   *   ]

 

 

[   *   ]

 

1                                          [   *   ]

1                                          [   *   ]

 

[   *   ]

 

1                                          [   *   ]
                                                    [   *   ]

1                                          [   *   ]
                                                    [   *   ]

 

 

[   *   ] include [   *   ] and [   *   ].

 

B-1

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

 

SCHEDULE C

 

[   *   ]

 

Section [   *   ] of the Agreement [   *   ] by the [   *   ] for certain
[   *   ] not [   *   ] to [   *   ] .  The [   *   ] of such [   *   ] shall
take place in accordance with the table and description below. 

 

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

 

[   *   ]

 

[   *   ] represents the [   *   ] of the [   *   ] that result in [   *   ]
that [   *   ] and/or [   *   ] The Parties estimate that for the [   *   ] ,
there may be [   *   ] that result in [   *   ] and/or Therefore, [   *   ] may,
[   *   ] up to [   *   ] to [   *   ] of [   *   ] five (5) Successful Batch
Runs [   *   ] shall [   *   ] In the event that [   *   ] must [   *   ] than
to [   *   ] the [   *   ] of [   *   ] , [   *   ] shall [   *   ] all
[   *   ] associated with [   *   ]

 

[   *   ]

 

[   *   ] estimate that for the [   *   ] there may be [   *   ] that result in
[   *   ] and/or [   *   ] Therefore, [   *   ] may [   *   ]up to [   *   ]
to[   *   ] of [   *   ] shall [   *   ] all [   *   ] associated with [   *   ]
In the event that [   *   ] must [   *   ] to [   *   ] the of [   *   ] ,
[   *   ] shall [   *   ] all [   *   ] associated with [   *   ]

 

[   *   ]

 

For all [   *   ] of [   *   ] there may be up to [   *   ] Therefore, [   *   ]
may, [   *   ] up to [   *   ] of [   *   ] of [   *   ] shall [   *   ] all
[   *   ] associated with these [   *   ] In the event that [   *   ] must
[   *   ] than [   *   ] to [   *   ] the [   *   ] of [   *   ]shall [   *   ]
all [   *   ] associated with [   *   ]

 

C-1

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

 

Schedule D

Form of Invoice and [   *   ] of [   *   ]

 

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

 

Schedule E

 

List of [   *   ]

 

(1)          For [   *   ]
[   *   ]  between [   *   ] and [   *   ]

 

[   *   ]

 

(2)          For [   *   ]
[   *   ]  for the [   *   ] of [   *   ] dated [   *   ] and [   *   ]

 

[   *   ]

 

E-1

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

 

Schedule F

Purchase Order BI Pharma

 

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

 

Schedule G

 

[   *   ]

 

 

[   *   ]

 

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

[   *   ]

 

 

G-1

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

 

Schedule H

 

[   *   ] as of Effective Date

 

[   *   ]

 

[   *   ]

 

H-1

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

 

Schedule I

 

Template of Certificates of Analysis for Drug Substance and Drug Product

 

For Drug Substance:

 

CERTIFICATE OF ANALYSIS

 

PRODUCT:

 

LOT NUMBER:

 

TEST

RESULT

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

This lot of material was manufactured to [       *              ] and to the
approved [       *              ].

 

 

QU Approval: ____________________________     Date: _____________________

 

I-1

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

 

For Drug Product:

 

CERTIFICATE OF ANALYSIS

 

PRODUCT:

 

LOT NUMBER:

 

TEST

RESULT

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

[               *              ]

 

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

[               *              ]

 

 

This lot of material was manufactured to [       *              ] and to the
approved [       *              ].

 

 

QU Approval: ____________________________     Date: _____________________

 

I-2

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