Exhibit 10.2

 

DEVELOPMENT AND LICENSE AGREEMENT

 

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

 

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

 

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

 

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

 

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

 

1.                                      DEFINITIONS

 

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

 

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

 

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

 

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

 

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

 

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

 

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

 

 

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

 

4

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Labor.

 

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

 

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

 

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

 

 

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

 

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

 

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

 

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

 

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

 

 

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

 

6

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

 

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

 

7

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

 

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

 

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

 

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

 

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

 

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

 

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

 

 

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

 

9

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

 

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

 

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

 

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

 

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

 

(A)                                   (I) TRADE, CASH AND QUANTITY DISCOUNTS
ACTUALLY ALLOWED OR TAKEN, INCLUDING DISCOUNTS TO GOVERNMENTAL OR MANAGED CARE
ORGANIZATIONS; (II) REBATES ACTUALLY PAID OR CREDITED, INCLUDING GOVERNMENT
REBATES SUCH AS MEDICAID CHARGEBACKS OR REBATES; (III) RETROACTIVE PRICE
REDUCTIONS OR ALLOWANCES ACTUALLY ALLOWED OR GRANTED FROM THE BILLED AMOUNT; AND
(IV) COMMERCIALLY REASONABLY PROMOTIONAL ALLOWANCES ACTUALLY GRANTED TO
CUSTOMERS AS REFLECTED ON THE SAME INVOICE AS FOR THE SALE OF LICENSED PRODUCT

 

(B)                                  CREDITS OR ALLOWANCES ACTUALLY GIVEN OR
MADE FOR REJECTION OF OR RETURN OF, PREVIOUSLY SOLD LICENSED PRODUCTS;

 

(C)                                   ANY CHARGES FOR INSURANCE, FREIGHT, AND
OTHER TRANSPORTATION COSTS DIRECTLY

 

 

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

 

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RELATED TO THE DELIVERY OF LICENSED PRODUCT TO THE EXTENT INCLUDED IN THE GROSS
INVOICED SALES PRICE;

 

(D)                                  ANY TAX, TARIFF, DUTY OR GOVERNMENTAL
CHARGE LEVIED ON THE SALES, TRANSFER, TRANSPORTATION OR DELIVERY OF A LICENSED
PRODUCT (INCLUDING ANY TAX SUCH AS A VALUE ADDED OR SIMILAR TAX OR GOVERNMENT
CHARGE) BORNE BY THE SELLER THEREOF, OTHER THAN FRANCHISE OR INCOME TAX OF ANY
KIND WHATSOEVER; AND

 

(E)                                   ANY IMPORT OR EXPORT DUTIES OR THEIR
EQUIVALENT BORNE BY THE SELLER.

 

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

 

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

 

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

 

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

 

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

 

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

 

12

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and reflected in the Research Plan.

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

 

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

 

13

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

 

2.                                      GRANT OF RIGHTS

 

2.1                               LICENSE GRANTS.

 

(A)                                   COMMERCIALIZATION LICENSE.

 

(I)                                     LICENSE TO CENTOCOR  SUBJECT TO THE
TERMS AND CONDITIONS OF THIS AGREEMENT, IMMUNOGEN HEREBY GRANTS TO CENTOCOR AN
EXCLUSIVE, ROYALTY-BEARING LICENSE, INCLUDING THE RIGHT TO GRANT SUBLICENSES AS
DESCRIBED IN SECTION 2.1(A)(II) BELOW, UNDER THE LICENSED PATENT RIGHTS AND
LICENSED TECHNOLOGY AND IMMUNOGEN’S INTEREST IN IMPROVEMENTS, TO DEVELOP, HAVE
DEVELOPED, MAKE, HAVE MADE, USE, HAVE USED, SELL, HAVE SOLD, OFFER FOR SALE,
IMPORT, HAVE IMPORTED, EXPORT AND HAVE EXPORTED LICENSED PRODUCTS IN THE FIELD
IN THE TERRITORY.

 

(II)                                  RIGHT TO SUBLICENSE.  CENTOCOR SHALL HAVE
THE RIGHT FREELY TO GRANT SUBLICENSES TO ALL OR ANY PORTION OF ITS RIGHTS UNDER
THE LICENSE RIGHTS GRANTED PURSUANT TO SECTION 2.1(A)(I) HEREOF TO ANY THIRD
PARTY; PROVIDED, HOWEVER, THAT (1) IMMUNOGEN SHALL BE NOTIFIED IN WRITING OF
EACH SUCH SUBLICENSE, (2) ANY AND ALL SUBLICENSES SHALL BE CONSISTENT WITH THE
TERMS AND CONDITIONS OF THIS AGREEMENT, AND (3) CENTOCOR SHALL REMAIN OBLIGATED
FOR THE PAYMENT TO IMMUNOGEN OF ALL OF ITS PAYMENT OBLIGATIONS HEREUNDER,
INCLUDING, WITHOUT LIMITATION, THE PAYMENT OF ANY MILESTONES AND ROYALTIES
DESCRIBED IN SECTION 5 HEREOF.

 

(B)                                  RESEARCH LICENSES.

 

(I)                                     RESEARCH LICENSE TO CENTOCOR  SUBJECT TO
THE TERMS AND CONDITIONS OF THIS AGREEMENT, DURING THE TERM OF THIS AGREEMENT,
IMMUNOGEN HEREBY GRANTS TO CENTOCOR A FULLY PAID-UP, NON-EXCLUSIVE,
ROYALTY-FREE, WORLDWIDE LICENSE, WITHOUT THE RIGHT TO GRANT SUBLICENSES, UNDER
THE LICENSED TECHNOLOGY AND LICENSED PATENT RIGHTS AND IMMUNOGEN’S INTEREST IN
ANY IMPROVEMENTS, FOR THE SOLE PURPOSE OF CONDUCTING THE ACTIVITIES IT IS
REQUIRED TO PERFORM AS PART OF THE RESEARCH PROGRAM.

 

(II)                                  RESEARCH LICENSE TO IMMUNOGEN.  SUBJECT TO
THE TERMS AND CONDITIONS OF THIS AGREEMENT, DURING THE TERM OF THIS AGREEMENT,
CENTOCOR HEREBY GRANTS TO IMMUNOGEN A FULLY PAID-UP, NON-EXCLUSIVE,
ROYALTY-FREE, WORLDWIDE LICENSE, WITHOUT THE RIGHT TO GRANT SUBLICENSES, UNDER
THE CENTOCOR BACKGROUND TECHNOLOGY AND CENTOCOR PATENT RIGHTS AND CENTOCOR’S
INTEREST IN ANY IMPROVEMENTS, CENTOCOR PROGRAM TECHNOLOGY AND JOINT PROGRAM
TECHNOLOGY, FOR THE SOLE PURPOSE OF CONDUCTING THE ACTIVITIES IT IS REQUIRED TO
PERFORM AS PART OF THE RESEARCH PROGRAM.

 

 

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

 

14

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

 

2.2                               RETAINED RIGHTS AND COVENANTS.

 

(A)                                   RETAINED RIGHTS.  SUBJECT TO THE OTHER
TERMS OF THIS AGREEMENT (INCLUDING, WITHOUT LIMITATION, SECTION 2.2(B)),
IMMUNOGEN RETAINS THE RIGHT TO USE THE LICENSED TECHNOLOGY AND ITS INTEREST IN
ANY IMPROVEMENTS AND PRACTICE THE LICENSED PATENT RIGHTS (A) TO PERFORM ITS
OBLIGATIONS UNDER THIS AGREEMENT (INCLUDING WITHOUT LIMITATION ITS OBLIGATION TO
MANUFACTURE PRECLINICAL MATERIALS AND CLINICAL MATERIALS IN ACCORDANCE WITH
SECTION 4 OF THIS AGREEMENT) (B) TO DEVELOP, HAVE DEVELOPED, MAKE, HAVE MADE,
USE, HAVE USED, SELL, HAVE SOLD, OFFER FOR SALE, IMPORT, HAVE IMPORTED, EXPORT
AND HAVE EXPORTED ANY PRODUCT THAT IS NOT A LICENSED PRODUCT, AND (C) FOR ANY
AND ALL USES OUTSIDE OF THE FIELD.

 

(B)                                  COVENANTS.  NOTWITHSTANDING ANYTHING TO THE
CONTRARY CONTAINED IN SECTION 2.2(A) OR 2.3 OF THIS AGREEMENT, IMMUNOGEN HEREBY
AGREES DURING THE TERM OF THIS AGREEMENT, THAT IT SHALL NOT GRANT TO ANY THIRD
PARTY ANY LICENSE OR OTHER RIGHT UNDER ANY PATENT RIGHTS OR TECHNOLOGY
CONTROLLED BY IMMUNOGEN TO DEVELOP, HAVE DEVELOPED, COMMERCIALIZE, HAVE
COMMERCIALIZED, MAKE OR HAVE MADE ANY PRODUCT CONTAINING A CONJUGATE OF A MAY
COMPOUND TO AN ANTIBODY WHICH SELECTIVELY AND SPECIFICALLY BINDS WITH
[**************************].

 

2.3                               IMPROVEMENT LICENSE TO IMMUNOGEN.  CENTOCOR
HEREBY GRANTS TO IMMUNOGEN A NON-EXCLUSIVE, FULLY PAID, IRREVOCABLE,
ROYALTY-FREE LICENSE, INCLUDING THE RIGHT TO GRANT SUBLICENSES, UNDER CENTOCOR’S
INTEREST IN IMPROVEMENTS CONTROLLED BY CENTOCOR (A) TO MANUFACTURE CLINICAL
MATERIALS OR PRECLINICAL MATERIALS PURSUANT TO THE TERMS OF THIS AGREEMENT,
AND/OR EACH APPLICABLE SUPPLY AGREEMENT (B) TO DEVELOP, MAKE, HAVE MADE, USE,
SELL, HAVE SOLD, OFFER FOR SALE, IMPORT, HAVE IMPORTED, EXPORT AND HAVE EXPORTED
ANY PRODUCT THAT IS NOT A LICENSED PRODUCT, AND (C) TO OTHERWISE EXPLOIT SUCH
IMPROVEMENTS FOR ALL USES OUTSIDE OF THE FIELD.

 

3.                                      RESEARCH PROGRAM; DEVELOPMENT AND
COMMERCIALIZATION
OF LICENSED PRODUCTS.

 

3.1                               RESEARCH PROGRAM.

 

(A)                                   IMPLEMENTATION OF RESEARCH PROGRAM. 
PROMPTLY FOLLOWING THE EXECUTION OF THIS AGREEMENT, THE PARTIES SHALL COOPERATE
IN CONDUCTING THE RESEARCH PROGRAM AS DESCRIBED

 

 

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

 

15

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

 

IN THE RESEARCH PLAN IN APPENDIX 3.1 ATTACHED HERETO. THE RESEARCH PROGRAM SHALL
BE DESIGNED TO FACILITATE THE SELECTION OF THE APPROPRIATE
[************************] ANTIBODIES AND MAY COMPOUNDS TO BE USED IN PREPARING
[*********************]-MAY CONJUGATES AND THE CONDUCT OF INITIAL RESEARCH WITH
RESPECT TO THE [*********************]-MAY CONJUGATES. THE RESEARCH PROGRAM
SHALL BE CONDUCTED PURSUANT TO A RESEARCH BUDGET AGREED TO BY THE PARTIES.  THE
PARTIES MAY, BY MUTUAL AGREEMENT, MAKE ADJUSTMENTS IN THE RESEARCH PLAN AND
RESEARCH BUDGET FROM TIME TO TIME DURING THE TERM OF THIS AGREEMENT.  EACH PARTY
UNDERTAKES THAT THE ACTIVITIES ASSIGNED TO IT IN A RESEARCH PLAN SHALL BE
CONDUCTED DILIGENTLY AND IN GOOD SCIENTIFIC MANNER IN ACCORDANCE WITH ACCEPTED
LABORATORY PRACTICES AND IN COMPLIANCE WITH ANY AND ALL LAWS, REGULATIONS AND
BIOETHICAL CONVENTIONS APPLICABLE TO THE JURISDICTION IN WHICH THOSE ACTIVITIES
TAKE PLACE.

 

(B)                                  COLLABORATIVE EFFORTS AND REPORTS.  THE
PARTIES AGREE THAT THE SUCCESSFUL EXECUTION OF THE RESEARCH PROGRAM WILL REQUIRE
THE COLLABORATIVE USE OF BOTH PARTIES’ AREAS OF EXPERTISE.  THE PARTIES SHALL
KEEP THE COLLABORATION COMMITTEE AND EACH OTHER FULLY INFORMED ABOUT THE STATUS
OF THE RESEARCH PROGRAM.  SCIENTISTS AT IMMUNOGEN AND CENTOCOR SHALL COOPERATE
IN THE PERFORMANCE OF THE RESEARCH PROGRAM AND, SUBJECT TO ANY CONFIDENTIALITY
OBLIGATIONS TO THIRD PARTIES, SHALL EXCHANGE INFORMATION AND MATERIALS IN A
MUTUALLY ACCEPTABLE SECURE MANNER AS NECESSARY TO CARRY OUT THE RESEARCH
PROGRAM, BUT SUBJECT TO THE PROVISIONS OF SECTION 6 HEREOF.  THE PARTIES EXPECT
THAT SUCH EXCHANGE OF INFORMATION AND MATERIALS MAY INVOLVE SHORT-TERM ON-SITE
VISITS BY SCIENTISTS OF EACH PARTY TO THE FACILITIES OF THE OTHER PARTY.

 

(C)                                   ADDITIONAL OBLIGATIONS OF IMMUNOGEN. 
SUBJECT TO THE OTHER TERMS OF THIS AGREEMENT, IMMUNOGEN MAY,
[******************************], CONDUCT SUCH ADDITIONAL RESEARCH ACTIVITIES,
AS IMMUNOGEN, IN ITS SOLE DISCRETION, ARE NECESSARY AS USEFUL FOR THE
DEVELOPMENT OF LICENSED PRODUCTS.  WITHOUT LIMITING THE GENERALITY OF THE
FOREGOING, IMMUNOGEN MAY FROM TIME TO TIME, PROVIDE CENTOCOR TECHNICAL
ASSISTANCE WITHIN IMMUNOGEN’S AREA OF EXPERTISE (OR ITS SUBCONTRACTORS)
CONCERNING THE DEVELOPMENT OF LICENSED PRODUCTS, PROVIDED THAT SUCH TECHNICAL
ASSISTANCE AND EXPERTISE IS WITHIN THE SCOPE OF THE LICENSED TECHNOLOGY AND/OR
LICENSED PATENT RIGHTS COVERED UNDER THIS AGREEMENT.  SUCH TECHNICAL

 

 

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

 

16

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

 

ASSISTANCE AND EXPERTISE SHALL INCLUDE, BUT NOT BE LIMITED TO, VISITS BY
IMMUNOGEN PERSONNEL TO CENTOCOR AND VISITS BY CENTOCOR PERSONNEL TO IMMUNOGEN
(OR ITS SUBCONTRACTORS), AT CENTOCOR’S EXPENSE, AT SUCH TIMES AND FOR SUCH
PERIODS OF TIME AS MAY BE REASONABLY ACCEPTABLE TO THE PARTIES.

 

(D)                                  SUPPLY OF PROPRIETARY MATERIALS.  FROM TIME
TO TIME DURING THE RESEARCH PROGRAM TERM, EITHER PARTY (THE “TRANSFERRING
PARTY”) MAY SUPPLY THE OTHER PARTY (THE “RECIPIENT PARTY”) WITH ITS PROPRIETARY
MATERIALS FOR USE IN THE RESEARCH PROGRAM.  IN CONNECTION THEREWITH, THE
RECIPIENT PARTY HEREBY AGREES THAT (I) IT SHALL NOT USE PROPRIETARY MATERIALS
FOR ANY PURPOSE OTHER THAN EXERCISING ANY RIGHTS GRANTED TO IT OR RESERVED BY IT
HEREUNDER; (II) IT SHALL USE THE PROPRIETARY MATERIALS ONLY IN COMPLIANCE WITH
ALL APPLICABLE, FEDERAL, STATE, AND LOCAL LAWS AND REGULATIONS; (III) IT SHALL
NOT TRANSFER ANY PROPRIETARY MATERIALS TO ANY THIRD PARTY WITHOUT THE PRIOR
WRITTEN CONSENT OF THE TRANSFERRING PARTY, EXCEPT AS EXPRESSLY PERMITTED HEREBY;
(IV) THE TRANSFERRING PARTY SHALL RETAIN FULL OWNERSHIP OF ALL SUCH PROPRIETARY
MATERIALS; AND (V) UPON THE EXPIRATION OR TERMINATION OF THIS AGREEMENT, THE
RECIPIENT PARTY SHALL AT THE INSTRUCTION OF THE TRANSFERRING PARTY EITHER
DESTROY OR RETURN ANY PROPRIETARY MATERIALS WHICH ARE NOT THE SUBJECT OF THE
GRANT OF A CONTINUING LICENSE HEREUNDER.

 

3.2                               DEVELOPMENT AND COMMERCIALIZATION.

 

(A)                                   RESPONSIBILITY.  SUBJECT TO SECTION 3.3 OF
THIS AGREEMENT, ON AND AFTER THE EFFECTIVE DATE, CENTOCOR SHALL HAVE SOLE
CONTROL AND AUTHORITY OVER THE DEVELOPMENT AND COMMERCIALIZATION OF LICENSED
PRODUCTS IN THE FIELD IN THE TERRITORY, INCLUDING, WITHOUT LIMITATION, (I) THE
CONDUCT OF ALL RESEARCH AND PRE-CLINICAL DEVELOPMENT ACTIVITIES (INCLUDING THE
ASSESSMENT OF ALTERNATIVE DESIGNS FOR THE [**********************]-MAY
CONJUGATES, THE SELECTION OF THE FINAL [************************] ANTIBODIES AND
MAY COMPOUNDS TO BE USED IN THE [*********************]-MAY CONJUGATES AND THE
SELECTION OF THE [***********************]-MAY CONJUGATES TO BE DEVELOPED AS
LICENSED PRODUCTS, ALL PRECLINICAL AND IND-ENABLING STUDIES, INCLUDING
TOXICOLOGY TESTING, ANY PHARMACEUTICAL DEVELOPMENT WORK ON FORMULATIONS OR
PROCESS DEVELOPMENT RELATING TO ANY SUCH LICENSED PRODUCTS), (II) ALL ACTIVITIES
RELATED TO HUMAN CLINICAL TRIALS, (III) SUBJECT TO SECTION 4 OF THIS

 

 

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

 

17

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

 

AGREEMENT, ALL ACTIVITIES RELATING TO THE MANUFACTURE AND SUPPLY OF
[***********************] ANTIBODIES, MAY COMPOUNDS AND LICENSED PRODUCTS, TO
THE EXTENT SUCH ACTIVITIES RELATE TO THE DEVELOPMENT AND COMMERCIALIZATION OF
LICENSED PRODUCTS (INCLUDING ALL REQUIRED PROCESS DEVELOPMENT AND SCALE UP WORK
WITH RESPECT THERETO), (IV) ALL COMMERCIALIZATION ACTIVITIES RELATING TO ANY
LICENSED PRODUCT, AND (V) ALL ACTIVITIES RELATING TO ANY REGULATORY FILINGS,
REGISTRATIONS, APPLICATIONS AND REGULATORY APPROVALS RELATING TO ANY OF THE
FOREGOING (INCLUDING ANY INDS OR FOREIGN EQUIVALENTS, ANY MANUFACTURING FACILITY
VALIDATION AND/OR LICENSURE, ANY DRUG APPROVAL APPLICATIONS AND ANY OTHER
REGULATORY APPROVALS).  EXCEPT AS DESCRIBED IN THE NEXT SENTENCE, CENTOCOR SHALL
OWN ALL TECHNOLOGY ARISING FROM ANY SUCH ACTIVITIES UNDER THIS AGREEMENT,
INCLUDING, WITHOUT LIMITATION, ALL REGULATORY FILINGS, REGISTRATIONS,
APPLICATIONS AND REGULATORY APPROVALS RELATING TO LICENSED PRODUCTS (INCLUDING
ANY INDS OR FOREIGN EQUIVALENTS, ANY DRUG APPROVAL APPLICATIONS AND ANY OTHER
REGULATORY APPROVALS), AND ALL OF THE FOREGOING TECHNOLOGY AND FILINGS,
REGISTRATIONS AND APPLICATIONS SHALL BE CONSIDERED CONFIDENTIAL INFORMATION
SOLELY OWNED BY CENTOCOR.  NOTWITHSTANDING THE FOREGOING, IMMUNOGEN SHALL OWN
ALL TECHNOLOGY ARISING FROM IMMUNOGEN’S ACTIVITIES RELATING TO THE MANUFACTURE
AND SUPPLY OF MAY COMPOUNDS TO CENTOCOR AND ALL OF THE FOREGOING TECHNOLOGY
SHALL BE CONSIDERED CONFIDENTIAL INFORMATION SOLELY OWNED BY IMMUNOGEN. 
NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, (I) ALL ACTIVITIES
RELATING TO DEVELOPMENT AND COMMERCIALIZATION OF LICENSED PRODUCTS UNDER THIS
AGREEMENT SHALL BE UNDERTAKEN AT CENTOCOR’S SOLE COST AND EXPENSE, EXCEPT AS
OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, (II) ALL BUSINESS DECISIONS,
INCLUDING, BUT NOT LIMITED TO, THE DESIGN, SALE, PRICE AND PROMOTION OF LICENSED
PRODUCTS UNDER THIS AGREEMENT AND THE DECISION WHETHER TO MARKET ANY PARTICULAR
LICENSED PRODUCT SHALL BE WITHIN THE SOLE DISCRETION OF CENTOCOR, (III) ANY
MARKETING OF A LICENSED PRODUCT IN ONE MARKET OR COUNTRY SHALL NOT OBLIGATE
CENTOCOR TO MARKET SAID LICENSED PRODUCT IN ANY OTHER MARKET OR COUNTRY AND (IV)
CENTOCOR MAKES NO WARRANTY OR REPRESENTATION THAT THE MARKETING OF ANY LICENSED
PRODUCT SHALL BE THE EXCLUSIVE MEANS BY WHICH CENTOCOR WILL PARTICIPATE IN THE
FIELD TO WHICH THE LICENSED PRODUCT RELATES.

 

(B)                                  DUE DILIGENCE.  CENTOCOR WILL USE
COMMERCIALLY REASONABLE EFFORTS TO

 

 

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

 

18

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

 

DEVELOP AND COMMERCIALIZE LICENSED PRODUCTS, AND TO UNDERTAKE INVESTIGATIONS AND
ACTIONS REQUIRED TO OBTAIN APPROPRIATE REGULATORY APPROVALS NECESSARY TO MARKET
LICENSED PRODUCTS, IN THE FIELD AND IN THE TERRITORY, SUCH COMMERCIALLY
REASONABLE EFFORTS TO BE IN ACCORDANCE WITH THE EFFORTS AND RESOURCES CENTOCOR
WOULD USE FOR A COMPOUND OWNED BY IT OR TO WHICH IT HAS RIGHTS, WHICH IS OF
SIMILAR MARKET POTENTIAL AT A SIMILAR STAGE IN DEVELOPMENT AS THE APPLICABLE
LICENSED PRODUCT, TAKING INTO ACCOUNT THE PROPRIETARY POSITION OF THE LICENSED
PRODUCT, THE RELATIVE POTENTIAL SAFETY AND EFFICACY OF THE LICENSED PRODUCT, THE
REGULATORY REQUIREMENTS INVOLVED IN ITS DEVELOPMENT, COMMERCIALIZATION AND
REGULATORY APPROVAL, THE COST OF GOODS AND AVAILABILITY OF CAPACITY TO
MANUFACTURE AND SUPPLY THE LICENSED PRODUCT AT COMMERCIAL SCALE, AND OTHER
RELEVANT FACTORS INCLUDING, WITHOUT LIMITATION, TECHNICAL, LEGAL, SCIENTIFIC OR
MEDICAL FACTORS.  IN DETERMINING WHETHER CENTOCOR IS USING THE EFFORTS DESCRIBED
IN THIS SECTION 4.4 TO DEVELOP A LICENSED PRODUCT THE PARTIES SHALL CONSIDER,
AMONG OTHER THINGS, WHETHER SUCH LICENSED PRODUCT IS IN ACTIVE DEVELOPMENT. 
“ACTIVE DEVELOPMENT” SHALL MEAN THAT AT ANY GIVEN TIME CENTOCOR SHALL BE
DILIGENTLY ENGAGING IN ONE OR MORE OF THE FOLLOWING DEVELOPMENT ACTIVITIES FOR A
GIVEN LICENSED PRODUCT:
[*************************************************************] FROM THE
[************************] OR [****************************] FOR ANY
[********************************************************] BEING [*******] OR
[***************] OR [*******************************************************
**************************************************************] AND
[*******************] OR [********************] AND [*****************] FROM A
[**********************] AND [********************] WITHIN [******************]
TO [********] ANY OF THE PRECEDING ACTIVITIES.  NOTWITHSTANDING THE FOREGOING,
CENTOCOR SHALL NOT BE CONSIDERED TO HAVE FAILED TO MEET ITS OBLIGATION TO USE
SUCH EFFORTS OR HAVE A LICENSED PRODUCT IN ACTIVE DEVELOPMENT IF SUCH FAILURE IS
DUE TO THE FAILURE ON THE PART OF IMMUNOGEN TO PROVIDE PRECLINICAL OR CLINICAL
MATERIALS UNDER ARTICLE 4 HEREOF.  IN THE EVENT THAT CENTOCOR FAILS TO USE
COMMERCIALLY REASONABLE EFFORTS AS REQUIRED HEREUNDER, THEN, IMMUNOGEN’S SOLE
REMEDY SHALL BE THE RIGHT, IN ITS SOLE DISCRETION TO (I) TERMINATE THE LICENSES
GRANTED UNDER SECTION 2.1 THIS AGREEMENT FOR BREACH UNDER SECTION 8.2(B) BELOW
(INCLUDING THE NOTICE AND CURE PROVISIONS

 

 

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

 

19

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

 

THEREIN) OR (II) CONVERT THE LICENSES GRANTED UNDER SECTION 2.1 OF THIS
AGREEMENT FROM EXCLUSIVE LICENSES TO NON-EXCLUSIVE LICENSES, IN EITHER CASE ONLY
AS SUCH LICENSES APPLY TO SUCH LICENSED PRODUCT IN SUCH COUNTRY, WHICH
TERMINATION OR CONVERSION, AS THE CASE MAY BE, SHALL BE EFFECTIVE UPON
EXPIRATION OF THE CURE PERIOD SPECIFIED IN 8.2(B) BELOW PROVIDED THAT SUCH
FAILURE REMAINS UNCURED UPON SUCH EXPIRATION.

 

3.3                               UPDATES AND REPORTS; NOTIFICATION OF
MILESTONES; EXCHANGE OF ADVERSE EVENT INFORMATION.

 

(A)                                   UPDATES AND REPORTS.  CENTOCOR SHALL KEEP
IMMUNOGEN INFORMED OF THE PROGRESS OF CENTOCOR’S EFFORTS TO DEVELOP AND
COMMERCIALIZE LICENSED PRODUCTS IN THE FIELD IN THE TERRITORY BY PROVIDING
IMMUNOGEN WITH BRIEF WRITTEN REPORTS NO LESS FREQUENTLY THAN ON EACH ANNIVERSARY
OF THE EFFECTIVE DATE DURING THE TERM OF THIS AGREEMENT (COMMENCING WITH THE
FIRST ANNIVERSARY OF THE EFFECTIVE DATE) WHICH SHALL SUMMARIZE CENTOCOR’S
EFFORTS TO DEVELOP AND COMMERCIALIZE SUCH LICENSED PRODUCTS, IDENTIFY THE DRUG
APPROVAL APPLICATIONS THAT CENTOCOR AND ITS SUBLICENSEES HAVE FILED, SOUGHT OR
OBTAINED IN THE PRIOR TWELVE (12)-MONTH PERIOD, AND ANY THEY REASONABLY EXPECT
TO MAKE, SEEK OR ATTEMPT TO OBTAIN IN THE FOLLOWING TWELVE (12)-MONTH PERIOD. 
THE PARTIES AGREE THAT THE MINUTES OF THE COLLABORATION COMMITTEE MEETINGS MAY
SERVE AS REPORTS HEREUNDER, TO THE EXTENT SUCH MINUTES ADEQUATELY ADDRESS THE
ABOVE ISSUES.

 

(B)                                  NOTIFICATION OF MILESTONE ACHIEVEMENT. 
CENTOCOR SHALL PROVIDE IMMUNOGEN WITH PROMPT WRITTEN NOTICE OF THE OCCURRENCE OF
ANY EVENT GIVING RISE TO AN OBLIGATION TO MAKE A MILESTONE PAYMENT TO IMMUNOGEN
UNDER SECTION 5.1.2, WHICH SHALL IN ANY EVENT BE NO LATER THAN [***********]
DAYS AFTER THE OCCURRENCE OF SUCH EVENT, AND SHALL PROVIDE IMMUNOGEN WITH PROMPT
WRITTEN NOTICE OF THE OCCURRENCE OF THE FIRST COMMERCIAL SALE OF ANY LICENSED
PRODUCT.  IN THE EVENT THAT, NOTWITHSTANDING THE FACT THAT CENTOCOR HAS NOT
GIVEN ANY SUCH NOTICE, IMMUNOGEN BELIEVES ANY SUCH MILESTONE EVENT HAS OCCURRED,
IT SHALL SO NOTIFY CENTOCOR IN WRITING, AND SHALL PROVIDE TO CENTOCOR THE DATA
AND INFORMATION DEMONSTRATING THAT THE CONDITIONS FOR PAYMENT HAVE BEEN
ACHIEVED.  WITHIN [***] ([***]) DAYS OF ITS RECEIPT OF SUCH NOTICE, THE PARTIES
SHALL MEET TO REVIEW THE DATA AND INFORMATION AND SHALL AGREE IN GOOD FAITH
WHETHER OR NOT THE CONDITIONS FOR PAYMENT HAVE BEEN ACHIEVED.

 

 

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

 

20

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

 

(C)                                   ADVERSE EVENTS.  AS THE OWNER OF ALL
REGULATORY APPROVALS, CENTOCOR WILL BE PRIMARILY RESPONSIBLE FOR ADVERSE EVENT,
SAFETY AND PHARMACOVIGILENCE REPORTING ON ALL LICENSED PRODUCTS.  TO THE EXTENT
THAT IT MAY APPLY TO A LICENSED PRODUCT, IMMUNOGEN AGREES TO PROVIDE CENTOCOR
WITH ADVERSE EVENT AND PRODUCT COMPLAINT INFORMATION RELATING TO ANY PRODUCT
CONTAINING ANY MAY COMPOUND THAT IS COMPILED AND PREPARED BY IMMUNOGEN OR ANY
THIRD PARTY IN THE NORMAL COURSE OF BUSINESS IN CONNECTION WITH THE DEVELOPMENT,
COMMERCIALIZATION OR SALE OF ANY SUCH PRODUCT, IN ACCORDANCE WITH PROCEDURES
THAT SHALL BE AGREED TO BY THE PARTIES BASED, IN GENERAL, ON SCHEDULE D ATTACHED
HERETO (IT BEING THE UNDERSTANDING OF THE PARTIES THAT SUCH SCHEDULE D IS
INCLUDED AS AN EXAMPLE ONLY AND SHALL NOT BE BINDING UPON THE PARTIES);
PROVIDED, HOWEVER, THAT THE FOREGOING SHALL NOT REQUIRE IMMUNOGEN TO VIOLATE ANY
AGREEMENTS WITH OR CONFIDENTIALITY OBLIGATIONS OWED TO ANY THIRD PARTY.  IN
ADDITION, CENTOCOR AGREES TO PROVIDE IMMUNOGEN WITH AGREED UPON ADVERSE EVENT
INFORMATION AND PRODUCT COMPLAINT INFORMATION RELATING TO LICENSED PRODUCTS AS
COMPILED AND PREPARED BY CENTOCOR IN THE NORMAL COURSE OF BUSINESS IN CONNECTION
WITH THE DEVELOPMENT OR COMMERCIALIZATION OF ANY LICENSED PRODUCT, WITHIN TIME
FRAMES CONSISTENT WITH REPORTING OBLIGATIONS UNDER APPLICABLE LAWS AND
REGULATIONS IN ACCORDANCE WITH PROCEDURES THAT SHALL BE AGREED TO BY THE PARTIES
BASED, IN GENERAL, ON SCHEDULE D ATTACHED HERETO (IT BEING THE UNDERSTANDING OF
THE PARTIES THAT SUCH SCHEDULE D IS INCLUDED AS AN EXAMPLE ONLY AND SHALL NOT BE
BINDING UPON THE PARTIES).  CENTOCOR SHALL PROVIDE ITS ADVERSE EVENT AND PRODUCT
COMPLAINT INFORMATION HEREUNDER TO IMMUNOGEN’S DESIGNATED REPRESENTATIVE, WHO
SHALL BE ITS CHIEF REGULATORY OFFICER UNLESS IMMUNOGEN OTHERWISE NOTIFIES
CENTOCOR.  IMMUNOGEN SHALL PROVIDE ITS ADVERSE EVENT AND PRODUCT COMPLAINT
INFORMATION HEREUNDER TO CENTOCOR’S DESIGNATED REPRESENTATIVE IDENTIFIED ON
SCHEDULE D UNLESS CENTOCOR OTHERWISE NOTIFIES IMMUNOGEN.

 

(D)                                  CORRESPONDENCE FOR LICENSED PRODUCTS.  TO
THE EXTENT REASONABLY PRACTICABLE AND SUBJECT TO ANY THIRD PARTY CONFIDENTIALITY
OBLIGATIONS, CENTOCOR SHALL PROVIDE IMMUNOGEN WITH COPIES OF ANY MATERIAL
DOCUMENTS OR CORRESPONDENCE PERTAINING TO IMMUNOGEN’S MANUFACTURE OF PRECLINICAL
MATERIALS, CLINICAL MATERIALS OR ANY LICENSED PRODUCT AND PREPARED FOR
SUBMISSION TO THE FDA AND ANY MATERIAL DOCUMENTS OR OTHER CORRESPONDENCE

 

 

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

 

21

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

 

RECEIVED FROM THE FDA PERTAINING TO IMMUNOGEN’S MANUFACTURE OF PRECLINICAL
MATERIALS, CLINICAL MATERIALS OR ANY LICENSED PRODUCT.  IMMUNOGEN SHALL COMPLETE
ITS REVIEW WITHIN [********] DAYS AFTER RECEIPT OF THE PROPOSED SUBMISSION. WHEN
REQUESTED IN WRITING, IMMUNOGEN SHALL PROVIDE REASONABLE ASSISTANCE TO CENTOCOR
IN OBTAINING REGULATORY APPROVALS FOR LICENSED PRODUCT.  NOTWITHSTANDING THE
FOREGOING, CENTOCOR SHALL HAVE THE SOLE RESPONSIBILITY FOR, AND IMMUNOGEN AGREES
THAT CENTOCOR SHALL BE THE SOLE OWNER OF, ANY REGULATORY APPROVAL FOR THE
LICENSED PRODUCT.

 

(E)                                   CONFIDENTIAL INFORMATION.  ALL REPORTS,
UPDATES, ADVERSE EVENT, PRODUCT COMPLAINT AND OTHER INFORMATION PROVIDED BY THE
DISCLOSING PARTY TO THE RECEIVING PARTY UNDER THIS AGREEMENT (INCLUDING UNDER
THIS SECTION 3.3), SHALL BE CONSIDERED CONFIDENTIAL INFORMATION OF THE
DISCLOSING PARTY, SUBJECT TO THE TERMS OF SECTION 6.

 

3.4                               COLLABORATION COMMITTEE.

 

(A)                                   MANDATE AND ESTABLISHMENT OF COMMITTEE. 
PROMPTLY AFTER THE EFFECTIVE DATE, THE PARTIES SHALL FORM A COLLABORATION
COMMITTEE TO SERVE AS A FORUM FOR COORDINATION AND COMMUNICATION BETWEEN THE
PARTIES WITH RESPECT TO THE RESEARCH PROGRAM AND/OR THE DEVELOPMENT OF
MANUFACTURING PROCESSES APPLICABLE TO ANY MAY COMPOUND OR LICENSED PRODUCT
COVERED BY THIS AGREEMENT (INCLUDING, WITHOUT LIMITATION, ALL PROCESS SCIENCE
AND PROCESS DEVELOPMENT WORK, FORMULATION WORK, AND QUALITY CONTROL/ASSURANCE
WORK HEREUNDER), AND TO ASSIST CENTOCOR IN ITS EXERCISE OF ITS RIGHTS TO MAKE OR
HAVE MADE LICENSED PRODUCTS UNDER THIS AGREEMENT.  WITHIN THIRTY (30) DAYS AFTER
THE EFFECTIVE DATE, THE PARTIES SHALL EACH NOMINATE AN EQUAL NUMBER OF
REPRESENTATIVES (WHICH SHALL BE NO LESS THAN TWO (2) EACH) FOR MEMBERSHIP ON THE
COLLABORATION COMMITTEE.  EACH PARTY MAY CHANGE ITS REPRESENTATIVE(S) AS IT
DEEMS APPROPRIATE BY NOTICE TO THE OTHER PARTY.

 

(B)                                  CHAIR OF COMMITTEE; MEETINGS.  THE CHAIR OF
THE COLLABORATION COMMITTEE SHALL BE ONE OF THE CENTOCOR REPRESENTATIVES ON THE
COLLABORATION COMMITTEE, AS DESIGNATED BY CENTOCOR.  THE COLLABORATION COMMITTEE
SHALL MEET ON A SEMI-ANNUAL BASIS OR OTHER SCHEDULE AGREED UPON BY THE PARTIES,
UNLESS AT LEAST THIRTY (30) DAYS IN ADVANCE OF ANY MEETING THE CHAIR OF THE
COLLABORATION COMMITTEE DETERMINES THAT THERE IS NO NEED FOR A MEETING.  IN SUCH
INSTANCE,

 

 

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

 

22

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

 

THE NEXT COLLABORATION COMMITTEE MEETING SHALL ALSO BE SCHEDULED AS AGREED UPON
BY THE PARTIES.  THE LOCATION OF MEETINGS OF THE COLLABORATION COMMITTEE SHALL
ALTERNATE BETWEEN IMMUNOGEN’S OFFICES AND CENTOCOR’S OFFICES IN CAMBRIDGE,
MASSACHUSETTS AND MALVERN/RADNOR/HORSHAM/ CHESTERBROOK/SPRINGHOUSE,
PENNSYLVANIA, RESPECTIVELY, UNLESS OTHERWISE AGREED BY THE PARTIES. AS AGREED
UPON BY THE PARTIES, COLLABORATION COMMITTEE MEETINGS MAY BE FACE-TO-FACE OR MAY
BE CONDUCTED THROUGH TELECONFERENCES AND/OR VIDEOCONFERENCES.  IN ADDITION TO
ITS COLLABORATION COMMITTEE REPRESENTATIVES, EACH PARTY SHALL BE ENTITLED TO
HAVE OTHER EMPLOYEES ATTEND SUCH MEETINGS TO PRESENT AND PARTICIPATE, THOUGH NOT
IN A DECISION-MAKING CAPACITY.  EACH PARTY SHALL BEAR ITS OWN COSTS AND
EXPENSES, INCLUDING TRAVEL AND LODGING EXPENSE, THAT MAY BE INCURRED BY
COLLABORATION COMMITTEE REPRESENTATIVES OR OTHER ATTENDEES AT COLLABORATION
COMMITTEE MEETINGS, AS A RESULT OF SUCH MEETINGS HEREUNDER.  MINUTES OF EACH
COLLABORATION COMMITTEE MEETING WILL BE TRANSCRIBED AND ISSUED TO MEMBERS OF THE
COLLABORATION COMMITTEE BY THE CHAIR WITHIN THIRTY (30) DAYS AFTER EACH MEETING,
AND SUCH MINUTES SHALL BE REVIEWED AND MODIFIED AS MUTUALLY REQUIRED TO OBTAIN
APPROVAL OF SUCH MINUTES PROMPTLY THEREAFTER.

 

4.                                      SUPPLY AND MANUFACTURING OBLIGATIONS

 

4.1                               SUPPLY OF PRECLINICAL MATERIALS, CLINICAL
MATERIALS AND LICENSED PRODUCT.  CENTOCOR SHALL BE RESPONSIBLE, AT ITS SOLE
COST, FOR MANUFACTURING OR HAVING MANUFACTURED THROUGH THIRD PARTY CONTRACT
MANUFACTURERS, ANY MATERIALS (INCLUDING WITHOUT LIMITATION, ALL
[**********************] ANTIBODIES, MAY COMPOUNDS AND [******************]-MAY
CONJUGATES) AS MAY BE REQUIRED FOR ALL PRECLINICAL AND CLINICAL STUDIES
NECESSARY TO OBTAIN REGULATORY APPROVAL OF LICENSED PRODUCTS AND ANY MATERIALS
AND/OR QUANTITIES OF EACH LICENSED PRODUCT AS MAY REQUIRED FOR ALL PRECLINICAL
AND CLINICAL STUDIES APPLICABLE TO SUCH LICENSED PRODUCT AND FOR
COMMERCIALIZATION OF SUCH LICENSED PRODUCT.

 

4.2                               SUPPLY OF PRECLINICAL MATERIALS BY IMMUNOGEN. 
NOTWITHSTANDING ANYTHING TO THE CONTRARY IN SECTION 4.1, DURING THE TERM OF THIS
AGREEMENT, CENTOCOR MAY REQUEST IMMUNOGEN TO SUPPLY CENTOCOR WITH SUCH
QUANTITIES OF PRECLINICAL MATERIALS AS MAY BE REASONABLY REQUIRED BY CENTOCOR IN
ORDER TO CONDUCT ALL PRE-CLINICAL DEVELOPMENT ACTIVITIES

 

 

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

 

23

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

 

(INCLUDING, WITHOUT LIMITATION, TOXICOLOGY TESTING) RELATING TO LICENSED
PRODUCTS.  CENTOCOR SHALL ORDER ALL AMOUNTS OF PRECLINICAL MATERIALS, AND
IMMUNOGEN SHALL DELIVER ALL SUCH ORDERED AMOUNTS, IN ACCORDANCE WITH ADVANCE
ORDERING TIMEFRAMES AND DELIVERY TIMEFRAMES AND SPECIFICATIONS TO BE AGREED UPON
BY THE PARTIES.  TO THE EXTENT CENTOCOR REQUESTS IMMUNOGEN TO MANUFACTURE ANY
[*********************]-MAY CONJUGATE, CENTOCOR SHALL SUPPLY IMMUNOGEN WITH
QUANTITIES OF [***************************] ANTIBODIES SUFFICIENT TO ENABLE
IMMUNOGEN TO PRODUCE SUCH [**************************]-MAY CONJUGATE.  IMMUNOGEN
SHALL USE COMMERCIALLY REASONABLE EFFORTS TO DELIVER TO CENTOCOR SUCH AMOUNTS OF
PRECLINICAL MATERIALS AS ARE ORDERED BY CENTOCOR IN ACCORDANCE WITH THE
FOREGOING (INCLUDING SUCH AGREED UPON TIMEFRAMES) IN A TIMELY MANNER; PROVIDED,
THAT, TO THE EXTENT SUCH PRECLINICAL MATERIALS ARE
[************************]-MAY CONJUGATES, IMMUNOGEN’S OBLIGATIONS SHALL BE
CONTINGENT ON IMMUNOGEN’S RECEIPT OF THE REQUIRED QUANTITIES OF
[************************] ANTIBODIES FROM CENTOCOR.  IN CONNECTION WITH ANY
ORDERING OF PRECLINICAL MATERIALS BY CENTOCOR, IMMUNOGEN SHALL PROVIDE CENTOCOR
PROMPTLY WITH IMMUNOGEN’S GOOD FAITH ESTIMATE OF THE COST FOR MANUFACTURE AND
SUPPLY OF SUCH PRECLINICAL MATERIALS.  IMMUNOGEN’S PRICE TO SUPPLY PRECLINICAL
MATERIALS TO CENTOCOR SHALL EQUAL [*************************] FOR SUCH
PRECLINICAL MATERIALS.  IN CONNECTION WITH SUCH SUPPLY, CENTOCOR HEREBY AGREES
THAT (A) IT SHALL NOT USE THE PRECLINICAL MATERIALS IN ANY HUMAN SUBJECT, (B) IT
SHALL USE THE PRECLINICAL MATERIALS IN COMPLIANCE WITH ALL APPLICABLE FEDERAL,
STATE AND LOCAL LAWS AND REGULATIONS, AND (C) IT (AS A MATTER OF CONTRACT
BETWEEN ITSELF AND IMMUNOGEN) SHALL ASSUME ALL LIABILITY FOR DAMAGES THAT MAY
ARISE FROM THE USE, STORAGE AND DISPOSAL OF ANY PRECLINICAL MATERIALS.  CENTOCOR
SHALL BE ENTITLED TO TRANSFER PRECLINICAL MATERIALS TO ANY THIRD PARTY UNDER
TERMS OBLIGATING SUCH THIRD PARTY NOT TO TRANSFER OR USE SUCH PRECLINICAL
MATERIALS EXCEPT IN COMPLIANCE WITH THE FOREGOING CLAUSES (A) AND (B) OF THIS
SECTION 4.2.

 

4.3                               SUPPLY OF CLINICAL MATERIALS BY IMMUNOGEN. 
IF, DURING THE TERM OF THIS AGREEMENT, CENTOCOR REQUESTS IN WRITING THAT
IMMUNOGEN SUPPLY CENTOCOR WITH SUCH QUANTITIES OF CLINICAL MATERIALS AS MAY BE
REASONABLY REQUIRED BY CENTOCOR IN ORDER TO CONDUCT HUMAN CLINICAL TRIALS OF
SUCH CLINICAL MATERIALS THROUGH THE COMPLETION OF NON-PIVOTAL PHASE II CLINICAL

 

 

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

 

24

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

 

TRIALS FOR SUCH CLINICAL MATERIALS, IMMUNOGEN WILL USE COMMERCIALLY REASONABLE
EFFORTS TO SUPPLY CENTOCOR WITH SUCH CLINICAL MATERIALS.  IF, DURING THE TERM OF
THIS AGREEMENT, CENTOCOR REQUESTS IN WRITING THAT IMMUNOGEN SUPPLY IT WITH
CLINICAL MATERIALS IN CONNECTION WITH THE CONDUCT OF PIVOTAL CLINICAL TRIALS,
IMMUNOGEN WILL SUPPLY CENTOCOR WITH SUCH CLINICAL MATERIALS ONLY TO THE EXTENT
IMMUNOGEN HAS THE CAPABILITY TO DO SO AT THE TIME OF CENTOCOR’S REQUEST.  IN
EITHER EVENT, THE PARTIES SHALL SHARE INFORMATION CONCERNING SPECIFICATIONS,
FORECASTING AND CAPACITY REQUIREMENTS IN ORDER TO ADEQUATELY PLAN FOR THE
MANUFACTURE OF SUCH CLINICAL MATERIALS. TO THE EXTENT CENTOCOR REQUESTS
IMMUNOGEN TO MANUFACTURE CLINICAL MATERIALS AS PROVIDED IN THE FOREGOING
SENTENCES, IMMUNOGEN AND CENTOCOR SHALL ENTER INTO A SEPARATE SUPPLY AND QUALITY
AGREEMENTS DETAILING THE TERMS OF SUPPLY FOR ANY CLINICAL MATERIALS THAT
IMMUNOGEN IS SO REQUESTED TO SUPPLY TO CENTOCOR FOR THE PURPOSE OF CONDUCTING
CLINICAL TRIALS, WHICH SUPPLY AGREEMENT SHALL INCLUDE, WITHOUT LIMITATION, THE
TERMS SET FORTH ON SCHEDULE B ATTACHED HERETO AND THE REMAINDER OF THIS
SECTION 4.3 (THE “SUPPLY AGREEMENT”).  SUBJECT TO THE FOREGOING, CENTOCOR SHALL
ORDER ALL AMOUNTS OF CLINICAL MATERIALS, AND IMMUNOGEN SHALL DELIVER ALL SUCH
ORDERED AMOUNTS, IN ACCORDANCE WITH FORECASTING PARAMETERS, ADVANCE ORDERING
TIMEFRAMES AND DELIVERY TIMEFRAMES TO BE AGREED UPON BY THE PARTIES IN THE
SUPPLY AGREEMENT.  THE SUPPLY AGREEMENT FURTHER SHALL PROVIDE THAT IMMUNOGEN
SHALL USE COMMERCIALLY REASONABLE EFFORTS TO DELIVER SUCH AMOUNTS OF CLINICAL
MATERIALS ORDERED IN ACCORDANCE WITH THE FOREGOING (INCLUDING SUCH AGREED UPON
TIMEFRAMES) IN A TIMELY MANNER; PROVIDED, THAT, IMMUNOGEN’S OBLIGATIONS SHALL BE
CONTINGENT ON IMMUNOGEN’S RECEIPT OF THE REQUIRED QUANTITIES OF
[************************] ANTIBODIES FROM CENTOCOR.  IN CONNECTION WITH ANY
ORDERING OF CLINICAL MATERIALS BY CENTOCOR, IMMUNOGEN SHALL PROVIDE CENTOCOR
PROMPTLY WITH IMMUNOGEN’S GOOD FAITH ESTIMATE OF THE COST FOR MANUFACTURE AND
SUPPLY OF SUCH CLINICAL MATERIALS.  THE SUPPLY AGREEMENT SHALL PROVIDE THAT
IMMUNOGEN’S PRICE TO SUPPLY CLINICAL MATERIALS TO CENTOCOR SHALL EQUAL
[************************************] FOR SUCH CLINICAL MATERIALS.  CENTOCOR
HEREBY AGREES THAT (A) IT SHALL USE THE CLINICAL MATERIALS IN COMPLIANCE WITH
ALL APPLICABLE FEDERAL, STATE AND LOCAL LAWS, AND (B) IT (AS A MATTER OF
CONTRACT BETWEEN ITSELF AND IMMUNOGEN) SHALL ASSUME ALL LIABILITY FOR DAMAGES
THAT MAY ARISE FROM THE

 

 

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

 

25

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

 

USE, STORAGE AND DISPOSAL OF SUCH CLINICAL MATERIALS.  CENTOCOR SHALL BE
ENTITLED TO TRANSFER CLINICAL MATERIALS TO ANY THIRD PARTY UNDER TERMS
OBLIGATING SUCH THIRD PARTY NOT TO TRANSFER OR USE SUCH CLINICAL MATERIALS
EXCEPT IN COMPLIANCE WITH THE FOREGOING CLAUSE (A) OF THIS SECTION 4.3.

 

4.4                               PURCHASE OF DEDICATED EQUIPMENT.  IF, DURING
THE TERM OF THIS AGREEMENT, IMMUNOGEN DETERMINES IN GOOD FAITH THAT IT IS
NECESSARY OR ADVISABLE TO PURCHASE DEDICATED EQUIPMENT IN ORDER TO PERFORM ANY
OF ITS OBLIGATIONS TO MANUFACTURE PRECLINICAL MATERIALS AND CLINICAL MATERIALS
UNDER SECTIONS 4.2 OR 4.3 OF THIS AGREEMENT, THEN IMMUNOGEN SHALL PROVIDE
CENTOCOR WITH WRITTEN NOTICE OF SUCH DETERMINATION, ALONG WITH THE ESTIMATED
PRICE FOR SUCH PURCHASE AND QUALITY PARAMETERS FOR THE DEDICATED EQUIPMENT, FOR
CENTOCOR’S APPROVAL OF SUCH PRICE AND FEATURES.  PROMPTLY AFTER THE CONSUMMATION
OF SUCH PURCHASE, ASSUMING THAT CENTOCOR HAS PROVIDED ITS APPROVAL HEREUNDER,
IMMUNOGEN SHALL PROVIDE CENTOCOR WITH A COPY OF THE INVOICE OR INVOICES
REFLECTING SUCH PURCHASE, AND CENTOCOR SHALL REIMBURSE IMMUNOGEN FOR THE
PURCHASE OF ALL SUCH APPROVED DEDICATED EQUIPMENT HEREUNDER WITHIN
[****************] OF ITS RECEIPT OF SUCH INVOICE FROM IMMUNOGEN; PROVIDED,
HOWEVER, THAT NO COSTS REIMBURSED BY CENTOCOR HEREUNDER (OR DEPRECIATION OF SUCH
PURCHASED EQUIPMENT OR INSTRUMENTS) SHALL BE INCLUDED WITHIN THE CALCULATION OF
ANY COSTS UNDER THIS AGREEMENT.  CENTOCOR SHALL HAVE TITLE AND OWNERSHIP OF ALL
SUCH DEDICATED EQUIPMENT PURCHASED PURSUANT TO THIS SECTION 4.4, AND SHALL HAVE
THE RIGHT TO RECLAIM OR RETAIN POSSESSION OF SUCH DEDICATED EQUIPMENT AT ITS
EXPENSE UPON REASONABLE NOTICE AT SUCH TIME AS IT IS NO LONGER REQUIRED FOR USE
BY IMMUNOGEN TO CARRY OUT THIS AGREEMENT.  NOTWITHSTANDING THE FOREGOING, THE
PURCHASE OF ITEMS INCLUDING, BUT NOT LIMITED TO, ROUTINE LAB EQUIPMENT,
BIOLOGICAL MATERIALS, PRODUCTS AND REAGENTS REASONABLY REQUIRED BY IMMUNOGEN TO
CONDUCT THE RESEARCH PROGRAM SHALL BE INCLUDED IN THE RESEARCH BUDGET AND SHALL
BE IMMUNOGEN’S OBLIGATION AND RESPONSIBILITY.

 

4.5                               PROCESS DEVELOPMENT ACTIVITIES.  TO THE EXTENT
THAT CENTOCOR REQUESTS THAT IMMUNOGEN MANUFACTURE PRECLINICAL MATERIALS OR
CLINICAL MATERIALS AS DESCRIBED IN THIS SECTION 4, IMMUNOGEN SHALL CONDUCT SUCH
PROCESS DEVELOPMENT ACTIVITIES AS THE PARTIES AGREE ARE NECESSARY TO PRODUCE THE
QUANTITIES OF PRECLINICAL MATERIALS OR CLINICAL MATERIALS SO ORDERED,

 

 

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

 

26

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

 

WHICH PROCESS DEVELOPMENT ACTIVITIES SHALL BE INCLUDED WITHIN THE CALCULATION OF
COST TO BE PAID BY CENTOCOR PURSUANT TO SECTIONS 4.2 AND/OR 4.3 OF THIS
AGREEMENT AND/OR THE SUPPLY AGREEMENT.

 

4.6                               AUDIT RIGHTS

 

4.6.1                     AUDIT OF RECORDS.  IMMUNOGEN WILL MAINTAIN COMPLETE
AND ACCURATE RECORDS WHICH ARE RELEVANT TO ITS SUPPLY OF PRECLINICAL MATERIALS
AS DESCRIBED IN THIS SECTION 4, FOR SUBSEQUENT USE IN GLP TOXICOLOGY STUDIES,
INCLUDING RECORDS CONCERNING THE COSTS, PURCHASE OF DEDICATED EQUIPMENT AND
PROCESS DEVELOPMENT ACTIVITIES.  IMMUNOGEN SHALL MAINTAIN ALL RECORDS RELATING
THERETO IN GOOD ORDER.  AT THE REQUEST OF CENTOCOR, UPON AT LEAST [***********]
BUSINESS DAYS’ PRIOR WRITTEN NOTICE, BUT NO MORE OFTEN THAN ONCE PER YEAR, AND
AT ITS SOLE EXPENSE (EXCEPT AS OTHERWISE PROVIDED HEREIN), IMMUNOGEN SHALL
PERMIT AN INDEPENDENT CERTIFIED PUBLIC ACCOUNTANT REASONABLY SELECTED BY
CENTOCOR AND REASONABLY ACCEPTABLE TO IMMUNOGEN TO INSPECT (DURING REGULAR
BUSINESS HOURS) THE RELEVANT RECORDS REQUIRED TO BE MAINTAINED BY IMMUNOGEN
UNDER THIS SECTION 4.5 (INCLUDING RECORDS PERTAINING TO IMMUNOGEN’S COMPLIANCE
WITH THE POLICY DESCRIBED IN SECTION 9.1).  AT CENTOCOR’S REQUEST, THE
ACCOUNTANT SHALL BE ENTITLED TO AUDIT THE THEN-PRECEDING [***********] YEARS OF
IMMUNOGEN’S RECORDS FOR PURPOSES OF VERIFYING IMMUNOGEN’S RECORDS CONCERNING
COSTS AND ITS PURCHASE OF DEDICATED EQUIPMENT.  TO THE EXTENT REQUESTED BY
IMMUNOGEN THE ACCOUNTANT SHALL ENTER INTO A CONFIDENTIALITY AGREEMENT WITH BOTH
PARTIES SUBSTANTIALLY SIMILAR TO THE PROVISIONS OF SECTION 6 LIMITING THE
DISCLOSURE AND USE OF SUCH INFORMATION BY SUCH ACCOUNTANT TO AUTHORIZED
REPRESENTATIVES OF THE PARTIES AND THE PURPOSES GERMANE TO THIS SECTION 4.5. 
THE RESULTS OF ANY SUCH AUDIT SHALL BE MADE AVAILABLE TO BOTH PARTIES AND SHALL
BE BINDING ON BOTH PARTIES.  CENTOCOR AGREES TO TREAT THE RESULTS OF ANY SUCH
ACCOUNTANT’S REVIEW OF IMMUNOGEN’S RECORDS UNDER THIS SECTION 4.5 AS
CONFIDENTIAL INFORMATION OF IMMUNOGEN SUBJECT TO THE TERMS OF SECTION 6.  IF ANY
SUCH AUDIT REVEALS AN OVERCHARGE TO CENTOCOR ATTRIBUTABLE TO A DEFICIENCY IN THE
CALCULATION OF COSTS, OR THE PURCHASE OF DEDICATED EQUIPMENT, IMMUNOGEN SHALL
PROMPTLY PAY CENTOCOR THE AMOUNT OF THE OVERPAYMENT (PLUS INTEREST THEREON AT
THE RATE PROVIDED IN SECTION 5.7 ABOVE), AND IF SUCH OVERPAYMENT IS BY [****]
PERCENT [*******] OR MORE, IMMUNOGEN SHALL PAY THE COSTS AND EXPENSES OF THE
AUDIT.

 

4.6.2                     AUDIT OF FACILITY.  IMMUNOGEN AGREES THAT, TO THE
EXTENT IMMUNOGEN

 

 

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

 

27

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

 

MANUFACTURES ANY PRECLINICAL MATERIALS UNDER THIS SECTION 4 FOR SUBSEQUENT USE
IN GLP TOXICOLOGY STUDIES, CENTOCOR SHALL HAVE THE RIGHT TO AUDIT, UNDER
APPROPRIATE CONFIDENTIALITY PROVISIONS, DURING NORMAL BUSINESS HOURS AND NOT
MORE OFTEN THAN ONCE PER YEAR, THE FACILITIES EMPLOYED AND THE DOCUMENTATION
UTILIZED BY IMMUNOGEN OR ITS CONTRACTORS OR SUBCONTRACTORS FOR MANUFACTURING
PRECLINICAL MATERIALS.  CENTOCOR MAY APPOINT A THIRD PARTY REASONABLY ACCEPTABLE
TO IMMUNOGEN TO PERFORM SUCH AUDIT; PROVIDED CENTOCOR HEREBY WARRANTS THAT SUCH
THIRD PARTY WILL ABIDE BY SECRECY AND NON-USE OBLIGATIONS NO LESS STRINGENT THAN
THOSE CONTAINED IN THIS AGREEMENT AND, TO THE EXTENT REQUESTED BY IMMUNOGEN,
CENOTOCOR TO PROVIDE IMMUNOGEN WITH A COPY OF THE CONFIDENTIALITY AGREEMENT
EVIDENCING SUCH SECRECY AND NON-USE OBLIGATIONS.  ALL SUCH AUDITS SHALL BE AT
CENTOCOR’S SOLE COST AND EXPENSE.  CENTOCOR WILL NOTIFY IMMUNOGEN AT LEAST
[************] BUSINESS DAYS IN ADVANCE OF SUCH AN AUDIT BY CENTOCOR AND
[***********] BUSINESS DAYS IN ADVANCE OF SUCH AN AUDIT BY A THIRD PARTY. 
IMMUNOGEN SHALL USE COMMERCIALLY REASONABLE EFFORTS TO REMEDY ANY MATERIAL
DEFICIENCIES IDENTIFIED IN SUCH AUDIT AS SOON AS POSSIBLE.  IN THE EVENT THAT,
SUBJECT TO THE OBLIGATION OF IMMUNOGEN TO USE COMMERCIALLY REASONABLE EFFORTS,
SUCH DEFICIENCIES CANNOT BE REMEDIED WITHIN [**************] BUSINESS DAYS,
IMMUNOGEN SHALL SO NOTIFY CENTOCOR AND CENTOCOR SHALL, AS ITS SOLE REMEDY, BE
ENTITLED TO TERMINATE THIS AGREEMENT IN ACCORDANCE WITH SECTION 8.2(B). 
IMMUNOGEN ACKNOWLEDGES THAT THE PROVISIONS OF THIS SECTION 4.6.2 GRANTING
CENTOCOR CERTAIN AUDIT RIGHTS SHALL IN NO WAY RELIEVE IMMUNOGEN OF ANY OF ITS
OBLIGATIONS UNDER THIS AGREEMENT, NOR SHALL SUCH PROVISIONS REQUIRE CENTOCOR TO
CONDUCT ANY SUCH AUDITS.

 

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

 

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

 

 

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

 

28

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

 

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

 

5.                                      PAYMENTS AND ROYALTIES

 

5.1                               MILESTONE PAYMENTS FOR LICENSED PRODUCTS.

 

5.1.1                     UPFRONT FEE.  IN CONSIDERATION OF THE GRANT OF THE
LICENSE DESCRIBED IN SECTION 2.1 HEREOF, CENTOCOR HEREBY AGREES TO PAY IMMUNOGEN
AN UPFRONT FEE (THE “UPFRONT FEE”) IN THE AMOUNT OF $1,000,000 PAYABLE IN
IMMEDIATELY AVAILABLE FUNDS WITHIN THREE (3) BUSINESS DAYS OF THE EFFECTIVE
DATE, WHICH UPFRONT FEE SHALL BE NON-REFUNDABLE AND NON-CREDITABLE.

 

5.1.2                     MILESTONES.  IN FURTHER CONSIDERATION OF THE GRANT OF
THE LICENSE BY IMMUNOGEN HEREUNDER, AND SUBJECT TO THE OTHER TERMS OF THIS
AGREEMENT, CENTOCOR WILL MAKE THE FOLLOWING PAYMENTS TO IMMUNOGEN WITHIN
[**********] DAYS AFTER THE FIRST OCCURRENCE OF EACH OF THE MILESTONES SET FORTH
BELOW:

 

Milestone

 

Milestone Payment

 

 

 

 

 

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

 

$

[********]

 

 

 

 

 

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

 

 

 

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

 

$

[********]

 

 

 

 

 

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

 

 

 

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

 

$

[********]

 

 

 

 

 

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

 

 

 

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

 

 

 

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

 

$

[********]

 

 

 

 

 

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

 

 

 

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

 

 

 

[********]

 

$

[********]

 

 

 

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

 

29

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

 

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

 

 

 

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

 

$

[********]

 

 

 

 

 

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

 

 

 

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

 

$

[********]

 

 

 

 

 

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

 

 

 

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

 

$

[********]

 

 

 

 

 

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

 

 

 

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

 

$

[********]

 

 

 

 

 

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

 

 

 

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

 

 

 

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

 

$

[********]

 

 

 

 

 

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

 

 

 

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

 

 

 

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

 

$

[********]

 

 

 

 

 

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

 

 

 

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

 

$

[********]

 

 

 

 

 

 

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

 

 

 

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

 

$

[********]

 

 

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

 

 

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

 

30

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

 

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

 

5.2                               RESEARCH FUNDING.  IN CONSIDERATION OF THE
PERFORMANCE BY IMMUNOGEN OF THE RESEARCH PROGRAM, CENTOCOR WILL PAY IMMUNOGEN
FOR ALL FTES USED BY IMMUNOGEN IN SUCH RESEARCH PROGRAM AND PURSUANT TO THE
RESEARCH BUDGET, AS DESCRIBED IN THE RESEARCH PLAN AND/OR AGREED TO BY THE
PARTIES, AT A RATE PER FTE EQUAL TO THE FTE RATE.  FROM TIME TO TIME AFTER THE
EFFECTIVE DATE, THE PARTIES SHALL AGREE IN WRITING UPON THE NUMBER OF FTES
REQUIRED OF IMMUNOGEN FOR AGREED-UPON PORTIONS OF THE RESEARCH PROGRAM AND
CENTOCOR SHALL PAY THE FTE COST FOR THE FTES REFLECTED IN SUCH WRITTEN
AGREEMENT.  IF, AT ANY TIME DURING THE TERM OF THIS AGREEMENT, IMMUNOGEN
DETERMINES THAT THE ACTUAL NUMBER OF FTES FOR A PARTICULAR PERIOD AGREED TO BY
THE PARTIES IS [******] TO [******] BY [********] THE FTE NUMBER SET FORTH IN
SUCH WRITTEN AGREEMENT FOR SUCH PERIOD, IMMUNOGEN SHALL GIVE CENTOCOR PROMPT
WRITTEN NOTICE OF SAME AND THE PARTIES SHALL DISCUSS IN GOOD FAITH WHETHER TO
[********] THE [***] OF SUCH [********] OR TO [********] THE [********] TO BE
[********], SUCH THAT SUCH [************] ARE [********] IMMUNOGEN WILL MAINTAIN
COMPLETE AND ACCURATE RECORDS WHICH ARE RELEVANT TO ITS EXPENDITURE OF RESEARCH
PROGRAM FUNDING PROVIDED TO IT BY CENTOCOR PURSUANT TO THIS ARTICLE 5.3 AS WELL
AS THE PURCHASE OF ANY DEDICATED EQUIPMENT PURSUANT TO SECTION 4.4 HEREOF. AT
THE REQUEST OF CENTOCOR, UPON AT LEAST [********] BUSINESS DAYS’ PRIOR WRITTEN
NOTICE, BUT NO MORE OFTEN THAN ONCE PER YEAR, AND AT ITS SOLE EXPENSE (EXCEPT AS
OTHERWISE PROVIDED HEREIN), IMMUNOGEN SHALL PERMIT AN INDEPENDENT CERTIFIED
PUBLIC ACCOUNTANT REASONABLY SELECTED BY CENTOCOR AND REASONABLY ACCEPTABLE TO
IMMUNOGEN TO INSPECT (DURING REGULAR BUSINESS HOURS) THE RELEVANT RECORDS
REQUIRED TO BE MAINTAINED BY IMMUNOGEN UNDER THIS SECTION 5.2.  AT CENTOCOR’S
REQUEST, THE ACCOUNTANT SHALL BE ENTITLED TO AUDIT THE THEN-PRECEDING [*****]
YEARS OF IMMUNOGEN’S RECORDS FOR PURPOSES OF VERIFYING IMMUNOGEN’S RECORDS
CONCERNING FTES. TO THE EXTENT REQUESTED BY IMMUNOGEN, THE ACCOUNTANT SHALL
ENTER INTO A CONFIDENTIALITY AGREEMENT WITH BOTH PARTIES SUBSTANTIALLY SIMILAR
TO THE PROVISIONS OF SECTION 6 LIMITING THE DISCLOSURE AND USE OF SUCH
INFORMATION BY SUCH ACCOUNTANT TO AUTHORIZED REPRESENTATIVES OF THE PARTIES AND
THE PURPOSES GERMANE TO THIS SECTION 5.2.  THE RESULTS OF ANY SUCH AUDIT SHALL
BE MADE AVAILABLE TO BOTH PARTIES AND SHALL BE BINDING ON BOTH PARTIES. 
CENTOCOR AGREES TO TREAT THE RESULTS OF ANY SUCH

 

 

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

 

31

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ACCOUNTANT’S REVIEW OF IMMUNOGEN’S RECORDS UNDER THIS SECTION 5.2 AS
CONFIDENTIAL INFORMATION OF IMMUNOGEN SUBJECT TO THE TERMS OF SECTION 6.  IF ANY
SUCH AUDIT REVEALS THAT THE ACTUAL FTES EXPENDED BY IMMUNOGEN ARE LESS THAN THE
AMOUNT OF FTES IMMUNOGEN INDICATED WAS EXPENDED, IMMUNOGEN SHALL PROMPTLY PAY
CENTOCOR THE AMOUNT OF OVERPAYMENT (PLUS INTEREST THEREON AT THE RATE PROVIDED
IN SECTION 5.7 ABOVE) MADE BY CENTOCOR WITH RESPECT TO SUCH FTES AND IF ANY SUCH
AUDIT REVEALS THAT THE ACTUAL FTES EXPENDED BY IMMUNOGEN WAS IN EXCESS OF THE
AMOUNT OF FTES IMMUNOGEN INDICATED WAS EXPENDED, CENTOCOR SHALL PROMPTLY PAY
IMMUNOGEN THE AMOUNT OF UNDERPAYMENT (PLUS INTEREST THEREON AT THE RATE PROVIDED
IN SECTION 5.7 ABOVE) WITH RESPECT TO SUCH FTES.

 

5.3                               PAYMENT OF ROYALTIES; ROYALTY RATES;
ACCOUNTING FOR ROYALTIES AND RECORDS.

 

5.3.1                     ROYALTY PAYMENTS.  IN FURTHER CONSIDERATION OF THE
GRANT OF THE LICENSE BY IMMUNOGEN HEREUNDER, AND SUBJECT TO THE OTHER TERMS OF
THIS AGREEMENT, COMMENCING ON THE FIRST DATE OF FIRST COMMERCIAL SALE OF
LICENSED PRODUCTS IN ANY COUNTRY OR JURISDICTION IN THE TERRITORY, CENTOCOR
SHALL PAY TO IMMUNOGEN THE FOLLOWING ROYALTIES BASED ON NET SALES OF ALL
LICENSED PRODUCTS SOLD BY CENTOCOR AND/OR ITS SUBLICENSEES WHICH WOULD, BUT FOR
THE LICENSE GRANTED HEREIN, INFRINGE A VALID CLAIM OF THE LICENSED PATENT RIGHTS
OR WHICH UTILIZES THE LICENSED TECHNOLOGY, ON AN INCREMENTAL BASIS IN EACH
CALENDAR YEAR DURING THE TERM, AT THE FOLLOWING RATES:

 

For Annual Worldwide Net Sales
of Licensed Products

 

Royalty Rate (% of Annual Net Sales)

 

 

 

 

 

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

 

[*]

%

 

 

 

 

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

 

[*]

%

 

 

 

 

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

 

[*]

%

 

 

 

 

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

 

[*]

%

 

5.3.2                     THIRD PARTY ROYALTY OFFSET.  IN THE EVENT THAT
CENTOCOR, IN ORDER TO EXPLOIT THE LICENSE GRANTED TO IT UNDER SECTION 2.1 OF
THIS AGREEMENT IN ANY COUNTRY IN THE TERRITORY, IS REQUIRED TO AND ACTUALLY
MAKES ROYALTY PAYMENTS TO ANY THIRD PARTY (“THIRD PARTY PAYMENTS”) (A) TO OBTAIN
A LICENSE TO AN ISSUED PATENT OR PATENTS IN THE ABSENCE OF WHICH THE

 

 

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

 

32

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MAY COMPOUND PORTION OF A LICENSED PRODUCT COULD NOT LEGALLY BE DEVELOPED,
MANUFACTURED OR SOLD IN SUCH COUNTRY AND/OR (B) TO OBTAIN A LICENSE TO AN ISSUED
PATENT OR PATENTS SPECIFIC TO THE LICENSED TECHNOLOGY USED BY IMMUNOGEN TO
CONJUGATE MAY COMPOUND TO ANTIBODIES, IN THE ABSENCE OF WHICH ANY OF THE
LICENSED PATENT RIGHTS NECESSARY TO CONJUGATE MAY COMPOUND TO AN ANTIBODY
CONTROLLED BY CENTOCOR AS PART OF A LICENSED PRODUCT CAN NOT LEGALLY BE
PRACTICED (AS EVIDENCED, TO THE EXTENT REASONABLY REQUESTED BY IMMUNOGEN, BY AN
OPINION OF PATENT COUNSEL), THEN ROYALTIES DUE TO IMMUNOGEN FOR SUCH LICENSED
PRODUCT MAY BE REDUCED BY [********] ([***]%) OF THE AMOUNT OF SUCH THIRD PARTY
PAYMENTS IN SUCH COUNTRY.  NOTWITHSTANDING THE FOLLOWING, ANY SUCH REDUCTIONS
UNDER THIS SECTION 5.3.2 SHALL IN NO EVENT REDUCE THE ROYALTY FOR SUCH LICENSED
PRODUCT PAYABLE UNDER SECTION 5.3.1 TO LESS THAN [*]% OF NET SALES IN SUCH
COUNTRY.

 

5.4                               ONE ROYALTY.  ONLY ONE ROYALTY, CALCULATED AT
THE HIGHEST APPLICABLE ROYALTY RATE UNDER THIS SECTION 5, SHALL BE PAYABLE TO
IMMUNOGEN HEREUNDER FOR EACH SALE OF A LICENSED PRODUCT.

 

5.5                               ROYALTY TERM.  CENTOCOR SHALL PAY ROYALTIES
WITH RESPECT TO EACH LICENSED PRODUCT ON A COUNTRY-BY-COUNTRY AND LICENSED
PRODUCT-BY-LICENSED PRODUCT BASIS UNTIL THE LATER OF (A) [********] YEARS FROM
THE FIRST COMMERCIAL SALE OF SUCH LICENSED PRODUCT IN SUCH COUNTRY AND (B) THE
EXPIRATION OF THE LAST TO EXPIRE VALID CLAIM OF THE LICENSED PATENT RIGHTS
COVERING THE LICENSED PRODUCT IN SUCH COUNTRY.  FOLLOWING SUCH ROYALTY TERM,
CENTOCOR SHALL HAVE A FULLY PAID-UP, IRREVOCABLE, FREELY TRANSFERABLE AND
SUBLICENSABLE LICENSE IN SUCH COUNTRY UNDER THE RELEVANT LICENSED PATENT RIGHTS
AND LICENSED TECHNOLOGY, TO DEVELOP, HAVE DEVELOPED, MAKE, HAVE MADE, USE, HAVE
USED, SELL, HAVE SOLD, OFFER FOR SALE, EXPORT, HAVE EXPORTED, IMPORT AND HAVE
IMPORTED SUCH LICENSED PRODUCT IN SUCH COUNTRY.

 

5.6                               PAYMENT TERMS.

 

(A)                                   PAYMENT OF MILESTONES; PAYMENT OF
ROYALTIES; ROYALTY REPORTS.  CENTOCOR SHALL MAKE ANY MILESTONE PAYMENTS OWED TO
IMMUNOGEN HEREUNDER IN UNITED STATES DOLLARS, USING THE WIRE TRANSFER PROVISIONS
OF SECTION 5.6(D) WITHIN [********] DAYS OF THE OCCURRENCE OF THE APPLICABLE
MILESTONE.  CENTOCOR SHALL MAKE ANY ROYALTY PAYMENTS OWED TO IMMUNOGEN IN

 

 

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

 

33

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

 

UNITED STATES DOLLARS, QUARTERLY WITHIN [******] DAYS FOLLOWING THE END OF EACH
CALENDAR QUARTER FOR WHICH SUCH ROYALTIES ARE DEEMED TO OCCUR (AS PROVIDED IN
THE NEXT SENTENCE), USING THE WIRE TRANSFER PROVISIONS OF SECTION 5.6(D).  FOR
PURPOSES OF DETERMINING WHEN A SALE OF ANY LICENSED PRODUCT OCCURS UNDER THIS
AGREEMENT, THE SALE SHALL BE DEEMED TO OCCUR ON THE EARLIER OF (I) THE DATE THE
LICENSED PRODUCT IS SHIPPED OR (II) THE DATE OF THE INVOICE TO THE PURCHASER OF
THE LICENSED PRODUCT.  EACH ROYALTY PAYMENT SHALL BE ACCOMPANIED BY A REPORT FOR
EACH COUNTRY IN THE TERRITORY IN WHICH SALES OF LICENSED PRODUCTS OCCURRED IN
THE CALENDAR QUARTER COVERED BY SUCH STATEMENT, SPECIFYING:  THE GROSS SALES (IF
AVAILABLE) AND NET SALES IN EACH COUNTRY’S CURRENCY; THE APPLICABLE ROYALTY RATE
UNDER THIS AGREEMENT; THE ROYALTIES PAYABLE IN EACH COUNTRY’S CURRENCY,
INCLUDING AN ACCOUNTING OF DEDUCTIONS TAKEN IN THE CALCULATION OF NET SALES; THE
APPLICABLE EXCHANGE RATE TO CONVERT FROM EACH COUNTRY’S CURRENCY TO UNITED
STATES DOLLARS UNDER THIS SECTION 5.6; AND THE ROYALTIES PAYABLE IN UNITED
STATES DOLLARS.

 

(B)                                  ACCOUNTING.  ALL PAYMENTS HEREUNDER SHALL
BE MADE IN THE UNITED STATES IN UNITED STATES DOLLARS. IN THE CASE OF SALES OF
ANY LICENSED PRODUCT OUTSIDE THE UNITED STATES, ROYALTY PAYMENTS BY CENTOCOR TO
IMMUNOGEN SHALL BE CONVERTED TO DOLLARS IN ACCORDANCE WITH CENTOCOR’S CURRENT
CUSTOMARY AND USUAL PROCEDURES FOR CALCULATING SAME WHICH ARE THE FOLLOWING: 
THE RATE OF CURRENCY CONVERSION SHALL BE CALCULATED USING A SIMPLE MONTHLY
PERIOD AVERAGE OF THE END “SPOT RATES” PROVIDED BY BROWN BROTHERS HARRIMAN, 59
WALL STREET, NY, NY 10005, FOR EACH QUARTER, OR IF SUCH RATE IS NOT AVAILABLE,
THE SPOT RATE AS PUBLISHED BY A LEADING UNITED STATES COMMERCIAL BANK FOR SUCH
ACCOUNTING PERIOD.  CENTOCOR HEREBY REPRESENTS TO IMMUNOGEN THAT THIS METHOD OF
CONVERSION IS CONSISTENT WITH CENTOCOR’S CURRENT ACCOUNTING METHODS.  CENTOCOR
SHALL GIVE IMMUNOGEN PROMPT WRITTEN NOTICE OF ANY CHANGES TO CENTOCOR’S
CUSTOMARY AND USUAL PROCEDURES FOR CURRENCY CONVERSION, WHICH SHALL ONLY APPLY
[********] DAYS AFTER SUCH NOTICE HAS BEEN DELIVERED AND PROVIDED THAT SUCH
CHANGES CONTINUE TO MAINTAIN A SET METHODOLOGY FOR CURRENCY CONVERSION.

 

(C)                                   TAX WITHHOLDING; RESTRICTIONS ON PAYMENT. 
 ALL PAYMENTS HEREUNDER SHALL BE MADE FREE AND CLEAR OF ANY TAXES, DUTIES,
LEVIES, FEES OR CHARGES, EXCEPT FOR WITHHOLDING TAXES (TO THE EXTENT
APPLICABLE).  CENTOCOR SHALL MAKE ANY APPLICABLE WITHHOLDING PAYMENTS DUE ON

 

 

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

 

34

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

 

BEHALF OF IMMUNOGEN AND SHALL PROMPTLY PROVIDE IMMUNOGEN WITH WRITTEN
DOCUMENTATION OF ANY SUCH PAYMENT SUFFICIENT TO SATISFY THE REQUIREMENTS OF THE
UNITED STATES INTERNAL REVENUE SERVICE RELATING TO AN APPLICATION BY IMMUNOGEN
FOR A FOREIGN TAX CREDIT FOR SUCH PAYMENT.  IF BY LAW, REGULATIONS OR FISCAL
POLICY OF A PARTICULAR COUNTRY IN THE TERRITORY, REMITTANCE OF ROYALTIES IN
UNITED STATES DOLLARS IS RESTRICTED OR FORBIDDEN, WRITTEN NOTICE THEREOF SHALL
PROMPTLY BE GIVEN TO IMMUNOGEN, AND PAYMENT OF THE ROYALTY SHALL BE MADE BY THE
DEPOSIT THEREOF IN LOCAL CURRENCY TO THE CREDIT OF IMMUNOGEN IN A RECOGNIZED
BANKING INSTITUTION DESIGNATED BY IMMUNOGEN BY WRITTEN NOTICE TO CENTOCOR.  WHEN
IN ANY COUNTRY IN THE TERRITORY THE LAW OR REGULATIONS PROHIBIT BOTH THE
TRANSMITTAL AND THE DEPOSIT OF ROYALTIES ON SALES IN SUCH COUNTRY, ROYALTY
PAYMENTS SHALL BE SUSPENDED FOR AS LONG A SUCH PROHIBITION IS IN EFFECT AND AS
SOON AS SUCH PROHIBITION CEASES TO BE IN EFFECT, ALL ROYALTIES THAT CENTOCOR
WOULD HAVE BEEN UNDER AN OBLIGATION TO TRANSMIT OR DEPOSIT BUT FOR THE
PROHIBITION SHALL FORTHWITH BE DEPOSITED OR TRANSMITTED, TO THE EXTENT
ALLOWABLE.

 

(D)                                  WIRE TRANSFERS.  ALL PAYMENTS HEREUNDER
SHALL BE MADE TO IMMUNOGEN BY BANK WIRE TRANSFER IN IMMEDIATELY AVAILABLE FUNDS
TO THE ACCOUNT DESIGNATED BY IMMUNOGEN BY WRITTEN NOTICE TO CENTOCOR FROM TIME
TO TIME.

 

5.7                               OVERDUE PAYMENTS.  SUBJECT TO THE OTHER TERMS
OF THIS AGREEMENT, ROYALTIES OR MILESTONES NOT PAID WITHIN THE TIME PERIOD SET
FORTH IN THIS SECTION 5 SHALL BEAR INTEREST AT A RATE EQUAL TO [********] PER
MONTH COMPOUNDED MONTHLY FROM THE DUE DATE UNTIL PAID IN FULL, PROVIDED THAT IN
NO EVENT SHALL SUCH ANNUAL RATE EXCEED THE MAXIMUM INTEREST RATE PERMITTED BY
LAW IN REGARD TO SUCH PAYMENTS.  SUCH ROYALTY OR MILESTONE PAYMENT WHEN MADE
SHALL BE ACCOMPANIED BY ALL INTEREST SO ACCRUED.  SUCH INTEREST AND THE PAYMENT
AND ACCEPTANCE THEREOF SHALL NOT NEGATE OR WAIVE THE RIGHT OF IMMUNOGEN TO ANY
OTHER REMEDY, LEGAL OR EQUITABLE, TO WHICH IT MAY BE ENTITLED BECAUSE OF THE
DELINQUENCY OF THE PAYMENT.

 

5.8                               RECORDS RETENTION; AUDIT.

 

(A)                                   ROYALTIES.  COMMENCING AS OF THE DATE OF
FIRST COMMERCIAL SALE OF THE FIRST LICENSED PRODUCT, CENTOCOR AND ITS AFFILIATES
AND SUBLICENSEES SHALL KEEP FOR AT LEAST [********] YEARS FROM THE END OF THE
CALENDAR YEAR TO WHICH THEY PERTAIN COMPLETE AND ACCURATE

 

 

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

 

35

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

 

RECORDS OF SALES BY CENTOCOR OR ITS AFFILIATES OR SUBLICENSEES, AS THE CASE MAY
BE, OF EACH LICENSED PRODUCT, IN SUFFICIENT DETAIL TO ALLOW THE ACCURACY OF THE
ROYALTIES TO BE CONFIRMED.

 

(B)                                  AUDIT.  SUBJECT TO THE OTHER TERMS OF THIS
SECTION 5.8(B), AT THE REQUEST OF IMMUNOGEN, UPON AT LEAST [********] BUSINESS
DAYS’ PRIOR WRITTEN NOTICE, BUT NO MORE OFTEN THAN ONCE PER YEAR, AND AT ITS
SOLE EXPENSE (EXCEPT AS OTHERWISE PROVIDED HEREIN), CENTOCOR SHALL PERMIT AN
INDEPENDENT CERTIFIED PUBLIC ACCOUNTANT REASONABLY SELECTED BY IMMUNOGEN AND
REASONABLY ACCEPTABLE TO CENTOCOR TO INSPECT (DURING REGULAR BUSINESS HOURS) THE
RELEVANT RECORDS REQUIRED TO BE MAINTAINED BY CENTOCOR UNDER SECTION 5.8(A).  AT
IMMUNOGEN’S REQUEST, THE ACCOUNTANT SHALL BE ENTITLED TO AUDIT THE
THEN-PRECEDING [********] YEARS OF CENTOCOR’S RECORDS FOR PURPOSES OF VERIFYING
CENTOCOR’S ROYALTY CALCULATIONS.  TO THE EXTENT REQUESTED BY CENTOCOR THE
ACCOUNTANT SHALL ENTER INTO A CONFIDENTIALITY AGREEMENT WITH BOTH PARTIES
SUBSTANTIALLY SIMILAR TO THE PROVISIONS OF SECTION 6 LIMITING THE DISCLOSURE AND
USE OF SUCH INFORMATION BY SUCH ACCOUNTANT TO AUTHORIZED REPRESENTATIVES OF THE
PARTIES AND THE PURPOSES GERMANE TO THIS SECTION 5.8.  RESULTS OF ANY SUCH AUDIT
SHALL BE MADE AVAILABLE TO BOTH PARTIES AND SHALL BE BINDING ON BOTH PARTIES. 
IMMUNOGEN AGREES TO TREAT THE RESULTS OF ANY SUCH ACCOUNTANT’S REVIEW OF
CENTOCOR’S RECORDS UNDER THIS SECTION 5.8 AS CONFIDENTIAL INFORMATION OF
CENTOCOR SUBJECT TO THE TERMS OF SECTION 6.  IF ANY SUCH AUDIT REVEALS A
DEFICIENCY IN THE CALCULATION OF ROYALTIES RESULTING FROM ANY UNDERPAYMENT BY
CENTOCOR, CENTOCOR SHALL PROMPTLY PAY IMMUNOGEN THE AMOUNT REMAINING TO BE PAID
(PLUS INTEREST THEREON AT A RATE EQUAL TO THE PRIME RATE PLUS [********] PERCENT
(**%)), AND IF SUCH UNDERPAYMENT IS BY [*****] PERCENT (**%) OR MORE, CENTOCOR
SHALL PAY THE COSTS AND EXPENSES OF THE AUDIT.

 

6.                                      TREATMENT OF CONFIDENTIAL INFORMATION

 

6.1                               CONFIDENTIAL INFORMATION.  IMMUNOGEN AND
CENTOCOR EACH RECOGNIZE THAT THE OTHER PARTY’S CONFIDENTIAL INFORMATION
CONSTITUTES HIGHLY VALUABLE AND PROPRIETARY CONFIDENTIAL INFORMATION.  DURING
THE TERM OF THIS AGREEMENT, AND FOR A PERIOD OF [********] YEARS AFTER THE
RECEIPT OF ANY SUCH CONFIDENTIAL INFORMATION FROM THE DISCLOSING PARTY
HEREUNDER, WHICHEVER IS LONGER, SUBJECT TO THE TERMS OF THIS SECTION 6, THE
RECEIVING PARTY SHALL KEEP CONFIDENTIAL AND NOT

 

 

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

 

36

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

 

DISCLOSE (BY PUBLICATION OR OTHERWISE) CONFIDENTIAL INFORMATION OF THE
DISCLOSING PARTY, AND SHALL NOT USE, PUBLISH OR OTHERWISE DISCLOSE CONFIDENTIAL
INFORMATION OF THE DISCLOSING PARTY FOR ANY PURPOSE OTHER THAN THOSE PURPOSES
CONTEMPLATED BY THIS AGREEMENT.  EACH RECEIVING PARTY SHALL TAKE SUCH ACTION,
AND SHALL CAUSE ITS AFFILIATES OR SUBLICENSEES TO TAKE SUCH ACTION, TO PRESERVE
THE CONFIDENTIALITY OF THE DISCLOSING PARTY’S CONFIDENTIAL INFORMATION AS IT
WOULD CUSTOMARILY TAKE TO PRESERVE THE CONFIDENTIALITY OF ITS OWN CONFIDENTIAL
INFORMATION, USING, IN ALL SUCH CIRCUMSTANCES, NOT LESS THAN REASONABLE CARE.
EACH RECEIVING PARTY, UPON THE REQUEST OF THE DISCLOSING PARTY, WILL RETURN ALL
THE CONFIDENTIAL INFORMATION DISCLOSED OR TRANSFERRED TO IT BY THE DISCLOSING
PARTY PURSUANT TO THIS AGREEMENT, INCLUDING ALL COPIES AND EXTRACTS OF DOCUMENTS
AND ALL MANIFESTATIONS IN WHATEVER FORM, WITHIN [********] DAYS OF SUCH REQUEST
OR, IF EARLIER, THE TERMINATION OR EXPIRATION OF THIS AGREEMENT; PROVIDED
HOWEVER, THAT A RECEIVING PARTY MAY RETAIN (A) ANY CONFIDENTIAL INFORMATION OF
THE DISCLOSING PARTY RELATING TO ANY LICENSE WHICH EXPRESSLY SURVIVES SUCH
TERMINATION AND (B) ONE (1) COPY OF ALL OTHER CONFIDENTIAL INFORMATION IN
INACTIVE ARCHIVES SOLELY FOR THE PURPOSE OF ESTABLISHING THE CONTENTS THEREOF.

 

6.2                               PERMITTED DISCLOSURES; PUBLICATIONS.

 

(A)                                   DISCLOSURES TO CERTAIN EMPLOYEES AND
AGENTS.  EACH RECEIVING PARTY SHALL BE ENTITLED TO DISCLOSE CONFIDENTIAL
INFORMATION OF THE DISCLOSING PARTY TO EMPLOYEES OF THE RECEIVING PARTY,
PROVIDED THAT SUCH EMPLOYEES ARE BOUND BY OBLIGATIONS OF CONFIDENTIALITY TO THE
RECEIVING PARTY, AND ALSO TO AFFILIATES, CONSULTANTS, AGENTS AND THIRD PARTIES
FOR ANY PURPOSE PROVIDED FOR IN THIS AGREEMENT, PROVIDED THAT ANY SUCH
AFFILIATE, CONSULTANT, AGENT OR OTHER THIRD PARTY HAS FIRST AGREED TO
CONFIDENTIALITY RESTRICTIONS AND OBLIGATIONS AT LEAST AS PROTECTIVE AS THIS
SECTION 6, IN EACH CASE FOR ANY PURPOSE CONTEMPLATED BY THIS AGREEMENT
(INCLUDING AS REASONABLY NECESSARY TO EXERCISE ANY RIGHTS OR PERFORM ANY
OBLIGATIONS UNDER THIS AGREEMENT).

 

(B)                                  OTHER PERMITTED DISCLOSURES. 
NOTWITHSTANDING THE FOREGOING, CONFIDENTIAL INFORMATION OF A DISCLOSING PARTY
MAY BE DISCLOSED BY THE RECEIVING PARTY TO THE EXTENT SUCH DISCLOSURE IS
REASONABLY NECESSARY FOR (I) FILING OR PROSECUTING PATENT APPLICATIONS OR
MAINTAINING PATENTS, (II) PROSECUTING OR DEFENDING LITIGATION, ENFORCING RIGHTS
AND/OR OBLIGATIONS UNDER THIS AGREEMENT, OR (III) COMPLYING WITH APPLICABLE
LAWS, REGULATIONS OR COURT ORDERS; PROVIDED, THAT, IF

 

 

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

 

37

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

 

A RECEIVING PARTY IS REQUIRED BY APPLICABLE LAW, REGULATION OR COURT ORDER TO
MAKE DISCLOSURE OF THE DISCLOSING PARTY’S CONFIDENTIAL INFORMATION, IT WILL GIVE
REASONABLE ADVANCE NOTICE TO THE DISCLOSING PARTY OF THE NEED FOR SUCH
DISCLOSURE AND WILL USE ITS COMMERCIALLY REASONABLE EFFORTS TO SECURE
CONFIDENTIAL TREATMENT (IF AVAILABLE) OF SUCH DISCLOSING PARTY’S CONFIDENTIAL
INFORMATION REQUIRED TO BE DISCLOSED.

 

(C)                                   REVIEW OF PUBLICATIONS.  EACH RECEIVING
PARTY SHALL CONSULT WITH THE DISCLOSING PARTY PRIOR TO THE SUBMISSION OF ANY
MANUSCRIPT OR ABSTRACT FOR PUBLICATION IF THE PUBLICATION WILL CONTAIN ANY
CONFIDENTIAL INFORMATION OF THE DISCLOSING PARTY, UNLESS THE APPLICABLE LAWS AND
REGULATIONS PROHIBIT SUCH CONSULTATION.  SUCH CONSULTATION SHALL INCLUDE
PROVIDING A COPY OF THE PROPOSED MANUSCRIPT OR ABSTRACT TO THE DISCLOSING PARTY
AT LEAST [********] DAYS PRIOR TO THE PROPOSED DATE OF SUBMISSION TO A
PUBLISHER, INCORPORATING APPROPRIATE CHANGES PROPOSED BY THE DISCLOSING PARTY
REGARDING ITS CONFIDENTIAL INFORMATION INTO THE MANUSCRIPT OR ABSTRACT
SUBMISSION AND DELETING ALL CONFIDENTIAL INFORMATION OF THE DISCLOSING PARTY AS
IT MAY REQUEST; PROVIDED, HOWEVER, THAT THE DISCLOSING PARTY’S REVIEW HEREUNDER
SHALL BE DEEMED COMPLETED AT THE END OF SUCH [********] DAY PERIOD.

 

6.3                               USE OF NAMES; PRESS RELEASES.

 

(A)                                   USE OF NAMES.  A PARTY MAY NOT USE THE
NAME OF THE OTHER PARTY (OR ANY TRADEMARKS OR TRADE NAMES OF THE OTHER PARTY) IN
ANY PRESS RELEASE OR ANY OTHER PUBLICITY OR ADVERTISING WITHOUT THE PRIOR
WRITTEN CONSENT OF THE OTHER PARTY.

 

(B)                                  PRESS RELEASES.  NEITHER PARTY MAY ISSUE A
PRESS RELEASE OR OTHERWISE PUBLICIZE OR DISCLOSE ANY INFORMATION RELATED TO THIS
AGREEMENT OR THE TERMS OR CONDITIONS HEREOF, WITHOUT THE PRIOR WRITTEN CONSENT
OF THE OTHER PARTY, WHICH CONSENT SHALL NOT BE UNREASONABLY WITHHELD OR DELAYED;
PROVIDED, HOWEVER, THAT EITHER PARTY MAY MAKE SUCH A DISCLOSURE (A) TO THE
EXTENT REQUIRED BY LAW OR BY THE REQUIREMENTS OF ANY NATIONALLY RECOGNIZED
SECURITIES EXCHANGE, QUOTATION SYSTEM OR OVER-THE-COUNTER MARKET ON WHICH SUCH
PARTY HAS ITS SECURITIES LISTED OR TRADED, OR (B) TO ANY INVESTORS, PROSPECTIVE
INVESTORS, LENDERS AND OTHER POTENTIAL FINANCING SOURCES WHO ARE OBLIGATED TO
KEEP SUCH INFORMATION CONFIDENTIAL.  IN THE EVENT THAT SUCH DISCLOSURE IS
REQUIRED AS AFORESAID, THE DISCLOSING PARTY SHALL MAKE REASONABLE EFFORTS TO
PROVIDE

 

 

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

 

38

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

 

THE OTHER PARTY WITH NOTICE BEFOREHAND AND TO COORDINATE WITH THE OTHER PARTY
WITH RESPECT TO THE WORDING AND TIMING OF ANY SUCH DISCLOSURE.  THE PARTIES
SHALL MUTUALLY AGREE ON THE TEXT OF ANY PRESS RELEASE ANNOUNCING THE EXECUTION
OF THIS AGREEMENT.  ONCE ANY WRITTEN TEXT IS APPROVED FOR DISCLOSURE BY BOTH
PARTIES AS PROVIDED HEREIN, EITHER PARTY MAY MAKE SUBSEQUENT OR REPEATED PUBLIC
DISCLOSURES OF THE CONTENTS THEREOF WITHOUT THE FURTHER APPROVAL OF THE OTHER
PARTY.

 

6.4                               INTEGRATION; SURVIVAL.  AS TO THE SUBJECT
MATTER OF THIS AGREEMENT, THIS SECTION 6 SUPERSEDES ANY CONFIDENTIAL DISCLOSURE
AGREEMENTS BETWEEN THE PARTIES, INCLUDING, WITHOUT LIMITATION, THE
CONFIDENTIALITY PROVISIONS OF THE MTA, AND OF THAT CERTAIN CONFIDENTIALITY
AGREEMENT EFFECTIVE [********].  ANY CONFIDENTIAL INFORMATION OF A PARTY UNDER
ANY SUCH AGREEMENT SHALL BE TREATED AS CONFIDENTIAL INFORMATION OF SUCH PARTY
HEREUNDER, SUBJECT TO THE TERMS OF THIS SECTION 6.  SECTION 6 SHALL SURVIVE
TERMINATION OR EXPIRATION OF THIS AGREEMENT.

 

7.                                      PROVISIONS CONCERNING THE FILING,
PROSECUTION AND
MAINTENANCE OF PATENT RIGHTS

 

7.1                               OWNERSHIP OF INTELLECTUAL PROPERTY.

 

(A)                                   SOLELY-OWNED TECHNOLOGY.  IMMUNOGEN SHALL
OWN (I) THE LICENSED PATENT RIGHTS, THE LICENSED TECHNOLOGY AND THE IMMUNOGEN
MATERIALS, (II) ALL IMMUNOGEN PROGRAM TECHNOLOGY (WHETHER OR NOT PATENTABLE),
AND (III) ALL IMPROVEMENTS MADE DURING THE COURSE OF AND PURSUANT TO ACTIVITIES
CARRIED OUT UNDER THIS AGREEMENT SOLELY BY EMPLOYEES OF OR AGENTS TO OR OTHERS
OBLIGATED TO ASSIGN INVENTIONS TO IMMUNOGEN.  CENTOCOR SHALL OWN (I) ALL
CENTOCOR PROGRAM TECHNOLOGY (WHETHER OR NOT PATENTABLE) AND (II) ALL
IMPROVEMENTS MADE DURING THE COURSE OF AND PURSUANT TO ACTIVITIES CARRIED OUT
UNDER THIS AGREEMENT SOLELY BY EMPLOYEES OF OR AGENTS TO OR OTHERS OBLIGATED TO
ASSIGN INVENTIONS TO CENTOCOR.  THE PARTY SOLELY OWNING ANY TECHNOLOGY HEREUNDER
SHALL BE THE SOLE OWNER OF ALL PATENT RIGHTS WITH RESPECT THERETO. ALL
DETERMINATIONS OF INVENTIVE CONTRIBUTION SHALL BE AS DETERMINED BY UNITED STATES
LAWS OF INVENTORSHIP.  SUBJECT TO THE TERMS OF SECTION 7.2 BELOW RELATING TO
IMPROVEMENTS, THE PARTY SOLELY OWNING AN INVENTION HEREUNDER WILL BE SOLELY
RESPONSIBLE, AT ITS OWN COST AND EXPENSE AND IN ITS SOLE DISCRETION, FOR THE
FILING, PROSECUTION AND MAINTENANCE OF ANY INVENTORSHIP

 

 

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

 

39

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

 

CERTIFICATE(S), PATENT APPLICATION(S) AND PATENT(S) THEREON.

 

(B)                                  JOINT TECHNOLOGY.  ALL JOINT PROGRAM
TECHNOLOGY AND ALL IMPROVEMENTS MADE DURING THE COURSE OF AND PURSUANT TO
ACTIVITIES CARRIED OUT UNDER THIS AGREEMENT JOINTLY BY EMPLOYEES OF OR AGENTS OF
OR OTHERS OBLIGATED TO ASSIGN INVENTIONS TO IMMUNOGEN AND CENTOCOR SHALL BE
JOINTLY OWNED BY IMMUNOGEN AND CENTOCOR.  ALL DETERMINATIONS OF INVENTIVE
CONTRIBUTION SHALL BE AS DETERMINED BY UNITED STATES LAWS OF INVENTORSHIP.  THE
PARTIES SHALL ALSO JOINTLY OWN ANY PATENT RIGHTS COVERING ANY SUCH JOINT PROGRAM
TECHNOLOGY AND/OR JOINTLY-OWNED IMPROVEMENTS.  THE TERMS OF SECTION 7.2 BELOW
RELATING TO JOINT PROGRAM TECHNOLOGY SHALL APPLY TO ANY SUCH PATENT RIGHTS.

 

(C)                                   DISCLOSURE.  AS REGARDS ANY IMMUNOGEN
PROGRAM TECHNOLOGY OR IMPROVEMENT HEREUNDER OR ANY CENTOCOR PROGRAM TECHNOLOGY
OR IMPROVEMENT HEREUNDER, EACH PARTY SHALL PROVIDE TO THE OTHER PARTY ANY
INVENTION DISCLOSURE MADE DURING THE COURSE OF PERFORMANCE OF THIS AGREEMENT AND
RELATING TO ACTIVITIES CARRIED OUT HEREUNDER WITHIN [********] DAYS AFTER SUCH
PARTY RECEIVES SUCH DISCLOSURE FROM ITS EMPLOYEES, AGENTS OR OTHERS OBLIGATED TO
ASSIGN INVENTIONS TO SUCH PARTY.

 

7.2                               PATENT FILING, PROSECUTION AND MAINTENANCE.

 

(A)                                   IMMUNOGEN RIGHTS.  SUBJECT TO THE OTHER
TERMS OF THIS SECTION 7.2, IMMUNOGEN SHALL HAVE THE RIGHT TO PREPARE, FILE,
PROSECUTE, OBTAIN AND MAINTAIN, AT ITS SOLE COST AND EXPENSE, ALL LICENSED
PATENT RIGHTS AND ALL PATENT RIGHTS COVERING IMPROVEMENTS MADE DURING THE COURSE
OF AND PURSUANT TO ACTIVITIES CARRIED OUT UNDER THIS AGREEMENT SOLELY BY
EMPLOYEES OF OR AGENTS TO OR OTHERS OBLIGATED TO ASSIGN INVENTIONS TO
IMMUNOGEN.  IMMUNOGEN WILL KEEP CENTOCOR REASONABLY INFORMED OF THE STATUS OF
EACH SUCH FILING, PROSECUTION AND MAINTENANCE, INCLUDING, WITHOUT LIMITATION, BY
USING REASONABLE COMMERCIAL EFFORTS TO PROVIDE CENTOCOR A REASONABLE TIME PRIOR
TO TAKING OR FAILING TO TAKE ANY ACTION THAT WOULD AFFECT THE SCOPE OR VALIDITY
OF ANY SUCH FILING (INCLUDING THE SUBSTANTIALLY NARROWING, CANCELLATION OR
ABANDONMENT OF ANY CLAIM(S) WITHOUT RETAINING THE RIGHT TO PURSUE SUCH SUBJECT
MATTER IN A SEPARATE APPLICATION, OR THE FAILURE TO FILE OR PERFECT THE FILING
OF ANY CLAIM(S) IN ANY COUNTRY), WITH PRIOR WRITTEN NOTICE OF SUCH PROPOSED
ACTION OR INACTION SO THAT CENTOCOR HAS A REASONABLE

 

 

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

 

40

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

 

OPPORTUNITY TO REVIEW AND COMMENT.  IF IMMUNOGEN FAILS TO UNDERTAKE THE
FILING(S) OF ANY PATENT APPLICATION WITH RESPECT TO ANY INVENTION UNDER SUCH
LICENSED PATENT RIGHTS OR SUCH PATENT RIGHTS COVERING IMPROVEMENTS WITHIN
[********] DAYS AFTER RECEIPT OF WRITTEN NOTICE FROM CENTOCOR THAT CENTOCOR
BELIEVES FILING OF SUCH AN APPLICATION BY IMMUNOGEN IS APPROPRIATE, CENTOCOR MAY
UNDERTAKE SUCH FILING(S) AT ITS OWN EXPENSE.

 

(B)                                  CENTOCOR RIGHTS.  SUBJECT TO THE OTHER
TERMS OF THIS SECTION 7.2, CENTOCOR SHALL HAVE THE RIGHT TO PREPARE, FILE,
PROSECUTE, OBTAIN AND MAINTAIN, AT ITS SOLE COST AND EXPENSE, ALL LICENSED
PATENT RIGHTS AND ALL PATENT RIGHTS COVERING IMPROVEMENTS MADE DURING THE COURSE
OF AND PURSUANT TO ACTIVITIES CARRIED OUT UNDER THIS AGREEMENT SOLELY BY
EMPLOYEES OF OR AGENTS TO OR OTHERS OBLIGATED TO ASSIGN INVENTIONS TO CENTOCOR. 
CENTOCOR WILL KEEP IMMUNOGEN REASONABLY INFORMED OF THE STATUS OF EACH SUCH
FILING, PROSECUTION AND MAINTENANCE, INCLUDING, WITHOUT LIMITATION, BY USING
REASONABLE COMMERCIAL EFFORTS TO PROVIDE IMMUNOGEN A REASONABLE TIME PRIOR TO
TAKING OR FAILING TO TAKE ANY ACTION THAT WOULD AFFECT THE SCOPE OR VALIDITY OF
ANY SUCH FILING (INCLUDING THE SUBSTANTIALLY NARROWING, CANCELLATION OR
ABANDONMENT OF ANY CLAIM(S) WITHOUT RETAINING THE RIGHT TO PURSUE SUCH SUBJECT
MATTER IN A SEPARATE APPLICATION, OR THE FAILURE TO FILE OR PERFECT THE FILING
OF ANY CLAIM(S) IN ANY COUNTRY), WITH PRIOR WRITTEN NOTICE OF SUCH PROPOSED
ACTION OR INACTION SO THAT IMMUNOGEN HAS A REASONABLE OPPORTUNITY TO REVIEW AND
COMMENT.  IF CENTOCOR FAILS TO UNDERTAKE THE FILING(S) OF ANY PATENT APPLICATION
WITH RESPECT TO ANY INVENTION UNDER SUCH PATENT RIGHTS COVERING IMPROVEMENTS
WITHIN [********] DAYS AFTER RECEIPT OF WRITTEN NOTICE FROM IMMUNOGEN THAT
IMMUNOGEN BELIEVES FILING OF SUCH AN APPLICATION BY CENTOCOR IS APPROPRIATE,
IMMUNOGEN MAY UNDERTAKE SUCH FILING(S) AT ITS OWN EXPENSE.

 

(C)                                   JOINT PROGRAM TECHNOLOGY.  AS REGARDS ANY
JOINT PROGRAM TECHNOLOGY, THE PARTY FROM WHOM THE MAJORITY OF THE DATA
UNDERLYING ANY SUCH JOINT PROGRAM TECHNOLOGY AROSE (THE “CONTROLLING PARTY”)
WILL HAVE THE FIRST RIGHT, BUT NOT THE OBLIGATION, TO UNDERTAKE FILING(S),
PROSECUTION AND MAINTENANCE OF INVENTORSHIP CERTIFICATE(S), PATENT
APPLICATION(S) AND PATENT(S) THEREON.  IN CONNECTION WITH ANY SUCH FILING(S),
THE FILING PARTY WILL USE PATENT COUNSEL MUTUALLY ACCEPTABLE TO EACH PARTY (IN
ITS REASONABLE DETERMINATION) AND THE PARTIES WILL, PRIOR TO

 

 

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

 

41

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

 

FILING OF THE PATENT APPLICATION, AGREE ON MUTUALLY ACCEPTABLE SHARING OF THE
COSTS AND EXPENSES OF SUCH FILING(S), PROSECUTION AND MAINTENANCE.  IN ANY CASE
THE FILING PARTY (I) WILL PROVIDE THE NON-CONTROLLING PARTY WITH A COPY OF ANY
SUCH PROPOSED PATENT APPLICATION FOR REVIEW AND COMMENT REASONABLY IN ADVANCE OF
FILING, AND (II) WILL KEEP THE NON-CONTROLLING PARTY REASONABLY INFORMED OF THE
STATUS OF SUCH FILING, PROSECUTION AND MAINTENANCE, INCLUDING, WITHOUT
LIMITATION, (A) BY PROVIDING THE NON-CONTROLLING PARTY WITH COPIES OF ALL
COMMUNICATIONS RECEIVED FROM OR FILED IN PATENT OFFICE(S) WITH RESPECT TO SUCH
FILING, AND (B) BY PROVIDING THE NON-CONTROLLING PARTY, A REASONABLE TIME PRIOR
TO TAKING OR FAILING TO TAKE ANY ACTION THAT WOULD AFFECT THE SCOPE OR VALIDITY
OF ANY SUCH FILING (INCLUDING THE SUBSTANTIALLY NARROWING, CANCELLATION OR
ABANDONMENT OF ANY CLAIM(S) WITHOUT RETAINING THE RIGHT TO PURSUE SUCH SUBJECT
MATTER IN A SEPARATE APPLICATION, OR THE FAILURE TO FILE OR PERFECT THE FILING
OF ANY CLAIM(S) IN ANY COUNTRY), WITH PRIOR WRITTEN NOTICE OF SUCH PROPOSED
ACTION OR INACTION SO THAT THE NON-CONTROLLING PARTY HAS A REASONABLE
OPPORTUNITY TO REVIEW AND COMMENT. IF THE PARTY FROM WHOM THE MAJORITY OF THE
DATA UNDERLYING ANY SUCH JOINT PROGRAM TECHNOLOGY FAILS TO UNDERTAKE THE
FILING(S) OF ANY SUCH PATENT APPLICATION WITH RESPECT TO ANY SUCH JOINT PROGRAM
TECHNOLOGY WITHIN [********] DAYS AFTER RECEIPT OF WRITTEN NOTICE FROM THE OTHER
PARTY THAT THE OTHER PARTY BELIEVES FILING(S) OF SUCH AN APPLICATION BY SUCH
PARTY IS APPROPRIATE, SUCH OTHER PARTY MAY UNDERTAKE SUCH FILING(S) AT ITS OWN
EXPENSE, IN WHICH CASE THE NON-FILING PARTY WILL ASSIGN ALL OF ITS RIGHTS TO
SUCH JOINT PROGRAM TECHNOLOGY TO THE FILING PARTY AND ANY SUBSEQUENTLY ISSUED
PATENT THEREON WILL BE OWNED SOLELY BY THE FILING PARTY.  EITHER PARTY MAY
ASSIGN ITS RIGHTS HEREUNDER TO ANY JOINT PROGRAM TECHNOLOGY, INVENTORSHIP
CERTIFICATE, PATENT APPLICATION OR PATENT TO THE OTHER PARTY, WHO WILL THEN HAVE
THE RIGHT, IN ITS DISCRETION, TO ASSUME THE FILING, PROSECUTION AND/OR
MAINTENANCE THEREOF AS THE SOLE OWNER THEREOF AND AT ITS SOLE COST AND EXPENSE.

 

7.3                               NOTICE OF INFRINGEMENT.  IF, DURING THE TERM
OF THIS AGREEMENT, EITHER PARTY LEARNS OF ANY ACTUAL, ALLEGED OR THREATENED
INFRINGEMENT BY A THIRD PARTY OF ANY LICENSED PATENT RIGHTS UNDER THIS
AGREEMENT, SUCH PARTY SHALL PROMPTLY NOTIFY THE OTHER PARTY AND SHALL PROVIDE
SUCH OTHER PARTY WITH AVAILABLE EVIDENCE OF SUCH INFRINGEMENT.

 

 

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

 

42

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

 

7.4                               INFRINGEMENT OF PATENT RIGHTS.

 

(A)                                   IMMUNOGEN RIGHTS TO CONTROL.  IMMUNOGEN
SHALL HAVE THE FIRST RIGHT (BUT NOT THE OBLIGATION), AT ITS OWN EXPENSE, TO
BRING AND CONTROL A SUIT (OR TAKE OTHER APPROPRIATE LEGAL ACTION) AGAINST ANY
ACTUAL, ALLEGED OR THREATENED INFRINGEMENT OF THE LICENSED PATENT RIGHTS, AND
PATENT RIGHTS WITH RESPECT TO IMPROVEMENTS MADE BY IMMUNOGEN, WITH LEGAL COUNSEL
OF ITS OWN CHOICE.  CENTOCOR SHALL HAVE THE RIGHT, AT ITS OWN EXPENSE, TO BE
JOINED AS A PARTY PLAINTIFF AND TO BE REPRESENTED IN ANY SUCH ACTION BY
IMMUNOGEN BY COUNSEL OF CENTOCOR’S OWN CHOICE; PROVIDED, HOWEVER, THAT UNDER NO
CIRCUMSTANCES SHALL THE FOREGOING AFFECT THE RIGHT OF IMMUNOGEN TO BRING AND
CONTROL THE SUIT AS DESCRIBED IN THE FIRST SENTENCE OF THIS SECTION 7.4(A).  NO
SETTLEMENT MAY BE ENTERED INTO BY IMMUNOGEN HOWEVER, WITHOUT THE WRITTEN CONSENT
OF CENTOCOR, WHICH CONSENT SHALL NOT BE UNREASONABLY WITHHELD OR DELAYED, IF
SUCH SETTLEMENT WOULD HAVE A MATERIAL ADVERSE EFFECT ON CENTOCOR’S INTERESTS. 
IF IMMUNOGEN DOES NOT FILE ANY ACTION OR PROCEEDING AGAINST SUCH INFRINGEMENT
WITHIN [****************] DAYS AFTER THE LATER OF (I) IMMUNOGEN’S NOTICE TO
CENTOCOR UNDER SECTION 7.3 ABOVE, (II) CENTOCOR’S NOTICE TO IMMUNOGEN UNDER
SECTION 7.3 ABOVE, OR (III) A WRITTEN REQUEST FROM CENTOCOR TO TAKE ACTION WITH
RESPECT TO SUCH INFRINGEMENT, THEN CENTOCOR SHALL HAVE THE RIGHT (BUT NOT THE
OBLIGATION), AT ITS OWN EXPENSE, TO BRING SUIT (OR TAKE OTHER APPROPRIATE LEGAL
ACTION) AGAINST SUCH ACTUAL, ALLEGED OR THREATENED INFRINGEMENT, WITH LEGAL
COUNSEL OF ITS OWN CHOICE. IMMUNOGEN SHALL HAVE THE RIGHT, AT ITS OWN EXPENSE,
TO BE REPRESENTED IN ANY SUCH ACTION BY CENTOCOR BY COUNSEL OF IMMUNOGEN’S OWN
CHOICE.  ANY DAMAGES, MONETARY AWARDS OR OTHER AMOUNTS RECOVERED, WHETHER BY
JUDGMENT OR SETTLEMENT, PURSUANT TO ANY SUIT, PROCEEDING OR OTHER LEGAL ACTION
TAKEN UNDER THIS SECTION 7.4(A), SHALL FIRST BE APPLIED TO REIMBURSE THE COSTS
AND EXPENSES (INCLUDING ATTORNEYS’ FEES) OF THE PARTY BRINGING SUCH SUIT OR
PROCEEDING OR TAKING SUCH OTHER LEGAL ACTION, THEN TO THE COSTS AND EXPENSES
(INCLUDING ATTORNEYS’ FEES), IF ANY, OF THE OTHER PARTY AND SECOND, TO CENTOCOR
IN REIMBURSEMENT FOR LOST SALES ASSOCIATED WITH LICENSED PRODUCTS AND TO
IMMUNOGEN IN REIMBURSEMENT FOR LOST ROYALTIES OWING HEREUNDER BASED ON SUCH LOST
SALES.  ANY OTHER DAMAGES, AWARDS OR AMOUNTS RECOVERED (INCLUDING FOR PUNITIVE
DAMAGES) SHALL BE ALLOCATED AS FOLLOWS:  (A) IF CENTOCOR IS THE PARTY BRINGING
SUCH SUIT OR PROCEEDING OR TAKING SUCH OTHER LEGAL ACTION, [********] PERCENT
(**%) TO CENTOCOR AND [********] PERCENT (**%) TO IMMUNOGEN, (B) IF IMMUNOGEN IS
THE

 

 

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

 

43

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

 

PARTY BRINGING SUCH SUIT OR PROCEEDING OR TAKING SUCH OTHER LEGAL ACTION,
[*************] (***%) TO IMMUNOGEN AND (C) IF THE SUIT IS BROUGHT JOINTLY,
[********] PERCENT (**%) TO EACH PARTY.  IF A PARTY BRINGS ANY SUCH ACTION OR
PROCEEDING HEREUNDER, THE OTHER PARTY AGREES TO BE JOINED AS PARTY PLAINTIFF IF
NECESSARY TO PROSECUTE SUCH ACTION OR PROCEEDING, AND TO GIVE THE PARTY BRINGING
SUCH ACTION OR PROCEEDING REASONABLE ASSISTANCE AND AUTHORITY TO FILE AND
PROSECUTE THE SUIT; PROVIDED, HOWEVER, THAT NEITHER PARTY SHALL BE REQUIRED TO
TRANSFER ANY RIGHT, TITLE OR INTEREST IN OR TO ANY PROPERTY TO THE OTHER PARTY
OR ANY THIRD PARTY TO CONFER STANDING ON A PARTY HEREUNDER.

 

(B)                                  INFRINGEMENT OF JOINT PROGRAM TECHNOLOGY. 
WITH RESPECT TO JOINT PROGRAM TECHNOLOGY, THE CONTROLLING PARTY (AS DEFINED IN
SECTION 7.2(B)) SHALL HAVE THE PRIMARY RIGHT, BUT NOT THE OBLIGATION, TO
INSTITUTE, PROSECUTE AND CONTROL ANY ACTION OR PROCEEDING WITH RESPECT TO
INFRINGEMENT OF SUCH PATENTS, BY COUNSEL OF ITS OWN CHOICE AND AT ITS OWN
EXPENSE; PROVIDED, HOWEVER, NO SETTLEMENT MAY BE ENTERED INTO BY THE CONTROLLING
PARTY WITHOUT THE WRITTEN CONSENT OF THE OTHER PARTY, WHICH CONSENT SHALL NOT BE
UNREASONABLY WITHHELD OR DELAYED, IF SUCH SETTLEMENT WOULD HAVE A MATERIAL
ADVERSE EFFECT ON SUCH OTHER PARTY’S INTEREST.  IN ANY EVENT, THE PARTIES WILL
CONSULT WITH EACH OTHER IN GOOD FAITH REGARDING THE BEST MANNER IN WHICH TO
PROCEED IN CONNECTION WITH ANY ACTUAL, ALLEGED OR THREATENED INFRINGEMENT OF ANY
PATENT RIGHTS JOINTLY OWNED BY IMMUNOGEN AND CENTOCOR UNDER THIS AGREEMENT,
INCLUDING ACTIONS AGAINST ANY ALLEGED INFRINGER.

 

7.5                               THIRD PARTY PATENTS.  IF ANY THIRD PARTY
CLAIMS THAT A PATENT IT OWNS OR CONTROLS CLAIMS ANY ASPECT OF A LICENSED PRODUCT
OR ITS MANUFACTURE, USE OR SALE, THE PARTY WITH NOTICE OF SUCH CLAIM SHALL
NOTIFY THE OTHER PARTY PROMPTLY, AND THE PARTIES SHALL AS SOON AS PRACTICABLE
THEREAFTER DISCUSS IN GOOD FAITH REGARDING THE BEST RESPONSE.

 

7.6                               PATENT ASSIGNMENT.  NEITHER PARTY MAY ASSIGN
ITS INTEREST IN RIGHTS UNDER JOINT PROGRAM TECHNOLOGY OR ANY PATENT RIGHTS
CLAIMING A LICENSED PRODUCT, EXCEPT WITH THE PRIOR WRITTEN CONSENT OF THE OTHER
PARTY, SUCH CONSENT NOT TO BE UNREASONABLY WITHHELD OR DELAYED; PROVIDED,
HOWEVER, THAT EITHER PARTY MAY ASSIGN SUCH RIGHTS WITHOUT CONSENT OF THE OTHER
PARTY TO A PERMITTED ASSIGNEE UNDER THIS AGREEMENT.

 

 

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

 

44

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

 

7.7                               NOTICES RELATING TO THE ACT.  IMMUNOGEN SHALL
NOTIFY CENTOCOR OF THE ISSUANCE OF EACH U.S. PATENT INCLUDED IN THE LICENSED
PATENT RIGHTS, GIVING THE DATE OF ISSUE AND PATENT NUMBER FOR EACH SUCH PATENT. 
IMMUNOGEN AND CENTOCOR EACH SHALL IMMEDIATELY GIVE NOTICE TO THE OTHER OF ANY
CERTIFICATION FILED UNDER THE “U.S. DRUG PRICE COMPETITION AND PATENT TERM
RESTORATION ACT OF 1984” (HEREINAFTER THE “ACT”), INCLUDING, BUT NOT NECESSARILY
LIMITED TO, NOTICES PURSUANT TO §§101 AND 103 OF THE ACT FROM PERSONS WHO HAVE
FILED AN ABBREVIATED NDA (“ANDA”) OR A “PAPER” NDA CLAIMING THAT PATENT RIGHTS
COVERING IMMUNOGEN PROGRAM TECHNOLOGY, CENTOCOR PROGRAM TECHNOLOGY, OR JOINT
PROGRAM TECHNOLOGY IS INVALID OR THAT INFRINGEMENT WILL NOT ARISE FROM THE
MANUFACTURE, USE OR SALE OF ANY LICENSED PRODUCT BY A THIRD PARTY.  THE
FOLLOWING PROVISIONS SHALL APPLY TO ANY SUCH CERTIFICATION:

 

(A)                                  IF CENTOCOR DECIDES NOT TO BRING
INFRINGEMENT PROCEEDINGS AGAINST THE ENTITY MAKING SUCH A CERTIFICATION OR
OTHERWISE FAILS TO GIVE NOTICE TO IMMUNOGEN OF ITS DECISION WITHIN [********]
DAYS AFTER RECEIPT OF NOTICE OF SUCH CERTIFICATION, IMMUNOGEN SHALL HAVE THE
RIGHT, BUT SHALL NOT BE REQUIRED, TO BRING SUIT AGAINST THE THIRD PARTY.

 

(B)                                 ANY SUIT BY CENTOCOR OR IMMUNOGEN UNDER THIS
SECTION 7.7 SHALL EITHER BE IN THE NAME OF CENTOCOR OR IN THE NAME OF IMMUNOGEN,
OR JOINTLY IN THE NAME OF CENTOCOR AND IMMUNOGEN, AS MAY BE REQUIRED BY LAW.

 

(C)                                  FOR PURPOSES OF THIS SECTION 7.7, THE PARTY
NOT BRINGING SUIT SHALL EXECUTE SUCH LEGAL PAPERS REASONABLY NECESSARY FOR THE
PROSECUTION OF SUCH SUIT AS MAY BE REASONABLY REQUESTED BY THE PARTY BRINGING
SUIT.

 

7.8                               PATENT TERM EXTENSIONS.  IN CONNECTION WITH
THE DEVELOPMENT AND COMMERCIALIZATION OF ANY LICENSED PRODUCT, IMMUNOGEN HEREBY
AUTHORIZES CENTOCOR (A) TO PROVIDE IN ANY NDA FILED WITH RESPECT TO ANY SUCH
LICENSED PRODUCT A LIST OF PATENTS WHICH INCLUDES THE LICENSED PATENT RIGHTS
THAT RELATE TO SUCH LICENSED PRODUCT; (B) SUBJECT TO SECTION 7.4 OF THIS
AGREEMENT, TO COMMENCE SUIT FOR INFRINGEMENT OF THE LICENSED PATENT RIGHTS THAT
RELATE TO SUCH LICENSED PRODUCT UNDER §271(E) (2) OF TITLE 35 OF THE UNITED
STATES CODE; AND (C) SUBJECT TO SECTION 7.4 OF THIS AGREEMENT, TO APPLY FOR AN
EXTENSION OF THE TERM OF ANY PATENT INCLUDED IN THE LICENSED PATENT RIGHTS THAT
RELATE TO SUCH LICENSED PRODUCT.  IN THE EVENT THAT

 

 

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

 

45

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

 

APPLICABLE LAW IN ANY COUNTRY PROVIDES FOR THE EXTENSION OF THE TERM OF ANY
PATENT INCLUDED IN THE LICENSED PATENT RIGHTS THAT RELATE TO SUCH LICENSED
PRODUCT, SUCH AS UNDER THE ACT, THE SUPPLEMENTARY CERTIFICATE OF PROTECTION OF
THE MEMBER STATES OF THE EUROPEAN UNION AND OTHER SIMILAR MEASURES IN ANY OTHER
COUNTRY, IMMUNOGEN SHALL APPLY FOR AND USE COMMERCIALLY REASONABLE EFFORTS TO
OBTAIN SUCH AN EXTENSION OR, SHOULD THE LAW REQUIRE CENTOCOR TO SO APPLY,
IMMUNOGEN SHALL GRANT PERMISSION TO CENTOCOR TO DO SO.  CENTOCOR AND IMMUNOGEN
AGREE TO COOPERATE WITH ONE ANOTHER IN OBTAINING SUCH EXTENSION.  IMMUNOGEN
AGREES TO COOPERATE WITH CENTOCOR OR ITS SUBLICENSEE, AS APPLICABLE, IN THE
EXERCISE OF THE AUTHORIZATION GRANTED HEREIN AND SHALL EXECUTE SUCH DOCUMENTS
AND TAKE SUCH ADDITIONAL ACTION AS CENTOCOR MAY REASONABLY REQUEST IN CONNECTION
THEREWITH, INCLUDING, IF NECESSARY, PERMITTING ITSELF TO BE JOINED AS A PARTY IN
ANY SUIT FOR INFRINGEMENT BROUGHT BY CENTOCOR HEREUNDER.

 

7.9                               TRADEMARKS.  ALL LICENSED PRODUCTS SHALL BE
SOLD UNDER ONE OR MORE TRADEMARKS AND TRADE NAMES SELECTED AND OWNED BY CENTOCOR
IN THE TERRITORY.  CENTOCOR SHALL CONTROL THE PREPARATION, PROSECUTION AND
MAINTENANCE OF APPLICATIONS RELATED TO ALL SUCH TRADEMARKS AND TRADE NAMES IN
THE TERRITORY, AT ITS SOLE COST AND EXPENSE AND AT ITS SOLE DISCRETION. 
IMMUNOGEN SHALL NOTIFY CENTOCOR PROMPTLY UPON LEARNING OF ANY ACTUAL, ALLEGED OR
THREATENED INFRINGEMENT OF A TRADEMARK OR TRADE NAME APPLICABLE TO A LICENSED
PRODUCT IN THE TERRITORY, OR OF ANY UNFAIR TRADE PRACTICES, TRADE DRESS
IMITATION, PASSING OFF OF COUNTERFEIT GOODS, OR LIKE OFFENSES IN THE TERRITORY. 
ALL OF THE COSTS, EXPENSES AND LEGAL FEES IN BRINGING, MAINTAINING AND
PROSECUTING ANY ACTION TO MAINTAIN, PROTECT OR DEFEND ANY OWNED BY CENTOCOR
HEREUNDER, AND ANY DAMAGES OR OTHER RECOVERY, SHALL BE CENTOCOR’S SOLE
RESPONSIBILITY, AND TAKEN IN ITS SOLE DISCRETION.

 

7.10                        INTEGRATION.  THIS SECTION 7 SUPERSEDES ANY
AGREEMENT BETWEEN THE PARTIES AS TO THE SUBJECT MATTER HEREOF, INCLUDING,
WITHOUT LIMITATION, ANY PROVISIONS OF THE MTA RELATING TO INVENTIONS, PATENT
APPLICATIONS AND PATENTS.

 

8.                                      TERM AND TERMINATION

 

8.1                               TERM; EXPIRATION.  THE TERM OF THIS AGREEMENT
(THE “TERM”) SHALL EXPIRE ON A COUNTRY-BY-COUNTRY BASIS UPON THE EXPIRATION OF
THE FINAL ROYALTY PAYMENT OBLIGATION WITH RESPECT

 

 

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

 

46

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

 

TO THE FINAL LICENSED PRODUCT UNDER SECTION 5.3.1 ABOVE.  UPON THE EXPIRATION OF
THE TERM OF THIS AGREEMENT, CENTOCOR SHALL HAVE A FULLY PAID-UP, IRREVOCABLE,
FREELY TRANSFERABLE AND SUBLICENSABLE LICENSE IN THE TERRITORY UNDER THE
LICENSED PATENT RIGHTS AND LICENSED TECHNOLOGY, TO DEVELOP, HAVE DEVELOPED,
COMMERCIALIZED, HAVE COMMERCIALIZED, MAKE, HAVE MADE, USE, HAVE USED, SELL, HAVE
SOLD, OFFER FOR SALE, IMPORT AND HAVE IMPORTED ANY AND ALL LICENSED PRODUCTS IN
THE TERRITORY.

 

8.2                               TERMINATION.  SUBJECT TO THE OTHER TERMS OF
THIS AGREEMENT:

 

(A)                                   VOLUNTARY TERMINATION BY CENTOCOR. 
CENTOCOR SHALL HAVE THE RIGHT TO TERMINATE THIS AGREEMENT AT ANY TIME UPON NOT
LESS THAN [********] DAYS’ PRIOR WRITTEN NOTICE TO IMMUNOGEN.

 

(B)                                  BREACH.  A PARTY MAY TERMINATE THIS
AGREEMENT AND THE LICENSES GRANTED HEREIN, EFFECTIVE UPON WRITTEN NOTICE TO THE
OTHER PARTY, UPON ANY BREACH BY THE OTHER PARTY OF ANY MATERIAL OBLIGATION OR
CONDITION OF THIS AGREEMENT, WHICH MATERIAL BREACH REMAINS UNCURED [********]
DAYS AFTER THE NON-BREACHING PARTY GIVES A FIRST WRITTEN NOTICE TO THE OTHER
PARTY DESCRIBING SUCH BREACH IN REASONABLE DETAIL; PROVIDED, HOWEVER, THAT IN
THE EVENT OF A PAYMENT BREACH BY CENTOCOR UNDER THIS AGREEMENT, THE APPLICABLE
CURE PERIOD SHALL BE [********] DAYS (IN LIEU OF [********] DAYS) BUT THE OTHER
TERMS OF THIS SECTION 8.2(B) SHALL APPLY TO TERMINATION IN CONNECTION WITH ANY
SUCH PAYMENT BREACH.  NOTWITHSTANDING ANYTHING SET FORTH HEREIN, IF THE ASSERTED
MATERIAL BREACH IS CURED OR SHOWN TO BE NON-EXISTENT WITHIN THE APPLICABLE CURE
PERIOD, THE FIRST NOTICE OF BREACH HEREUNDER SHALL BE DEEMED AUTOMATICALLY
WITHDRAWN AND OF NO EFFECT.

 

(C)                                   BANKRUPTCY.  A PARTY MAY TERMINATE THIS
AGREEMENT, EFFECTIVE ON WRITTEN NOTICE TO THE OTHER PARTY, IN THE EVENT THE
OTHER PARTY SHALL HAVE BECOME INSOLVENT OR BANKRUPT, OR SHALL HAVE MADE AN
ASSIGNMENT FOR THE BENEFIT OF ITS CREDITORS, OR THERE SHALL HAVE BEEN APPOINTED
A TRUSTEE OR RECEIVER OF THE OTHER PARTY OR FOR ALL OR A SUBSTANTIAL PART OF ITS
PROPERTY, OR ANY CASE OR PROCEEDING SHALL HAVE BEEN COMMENCED OR OTHER ACTION
TAKEN BY OR AGAINST THE OTHER PARTY IN BANKRUPTCY OR SEEKING REORGANIZATION,
LIQUIDATION, DISSOLUTION, WINDING-UP, ARRANGEMENT, COMPOSITION OR READJUSTMENT
OF ITS DEBTS OR ANY OTHER RELIEF UNDER ANY BANKRUPTCY, INSOLVENCY,
REORGANIZATION OR OTHER SIMILAR ACT OR LAW OF ANY JURISDICTION NOW OR HEREAFTER
IN EFFECT, OR THERE

 

 

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

 

47

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

 

SHALL HAVE BEEN ISSUED A WARRANT OF ATTACHMENT, EXECUTION, DISTRAINT OR SIMILAR
PROCESS AGAINST ANY SUBSTANTIAL PART OF THE PROPERTY OF THE OTHER PARTY, AND ANY
SUCH FOREGOING EVENTS SHALL HAVE CONTINUED FOR [********] DAYS UNDISMISSED,
UNBONDED AND UNDISCHARGED.  ALL RIGHTS AND LICENSES GRANTED UNDER THIS AGREEMENT
ARE, AND SHALL BE DEEMED TO BE, FOR PURPOSES OF SECTION 365(N) OF THE UNITED
STATES BANKRUPTCY CODE, LICENSES OF RIGHTS TO “INTELLECTUAL PROPERTY” AS DEFINED
UNDER SECTION 101(56) OF THE UNITED STATES BANKRUPTCY CODE.  THE PARTIES AGREE
THAT IN THE EVENT OF THE COMMENCEMENT OF A BANKRUPTCY PROCEEDING BY OR AGAINST
ONE PARTY HEREUNDER UNDER THE UNITED STATES BANKRUPTCY CODE, THE OTHER PARTY
SHALL BE ENTITLED TO COMPLETE ACCESS TO ANY SUCH INTELLECTUAL PROPERTY, AND ALL
EMBODIMENTS OF SUCH INTELLECTUAL PROPERTY, PERTAINING TO THE RIGHTS GRANTED IN
THE LICENSES HEREUNDER OF THE PARTY BY OR AGAINST WHOM A BANKRUPTCY PROCEEDING
HAS BEEN COMMENCED, SUBJECT, HOWEVER, TO PAYMENT OF THE MILESTONE AMOUNTS AND
ROYALTIES SET FORTH IN THIS AGREEMENT THROUGH THE EFFECTIVE DATE OF ANY
TERMINATION HEREUNDER.

 

8.3                               EFFECTS OF TERMINATION.  UPON ANY TERMINATION
OF THIS AGREEMENT BY EITHER PARTY UNDER SECTION 8.2, AS OF THE EFFECTIVE DATE OF
SUCH TERMINATION, ALL RELEVANT LICENSES AND SUBLICENSES GRANTED BY IMMUNOGEN TO
CENTOCOR HEREUNDER SHALL TERMINATE AUTOMATICALLY.  NOTWITHSTANDING THE
FOREGOING, AND UNLESS IMMUNOGEN SPECIFIES OTHERWISE IN WRITING, (A) NO SUCH
TERMINATION OF THIS AGREEMENT SHALL BE CONSTRUED AS A TERMINATION OF ANY VALID
SUBLICENSE OF ANY SUBLICENSEE HEREUNDER, AND THEREAFTER EACH SUCH SUBLICENSEE
SHALL BE CONSIDERED A DIRECT LICENSEE OF IMMUNOGEN, PROVIDED, THAT, (I) SUCH
SUBLICENSEE IS THEN IN FULL COMPLIANCE WITH ALL TERMS AND CONDITIONS OF ITS
SUBLICENSE, (II) ALL ACCRUED PAYMENTS OBLIGATIONS TO IMMUNOGEN HAVE BEEN PAID,
AND (III) SUCH SUBLICENSEE AGREES AT LEAST [**************] PRIOR TO THE
EFFECTIVE DATE OF SUCH TERMINATION TO ASSUME ALL OBLIGATIONS OF CENTOCOR UNDER
THIS AGREEMENT, AND (B) CENTOCOR AND ITS SUBLICENSEES SHALL HAVE THE RIGHT, FOR
[********] MONTHS OR SUCH LONGER TIME PERIOD (IF ANY) ON WHICH THE PARTIES
MUTUALLY AGREE IN WRITING, TO SELL OR OTHERWISE DISPOSE OF ALL LICENSED PRODUCTS
THEN ON HAND, WITH ROYALTIES TO BE PAID TO IMMUNOGEN ON ALL NET SALES OF SUCH
LICENSED PRODUCTS AS PROVIDED FOR IN THIS AGREEMENT.

 

8.4                               REMEDIES.  EXCEPT AS OTHERWISE EXPRESSLY SET
FORTH IN THIS AGREEMENT, THE TERMINATION PROVISIONS OF THIS SECTION 8 ARE IN
ADDITION TO ANY OTHER RELIEF AND REMEDIES AVAILABLE

 

 

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

 

48

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

 

TO EITHER PARTY AT LAW.

 

8.5                               SURVIVING PROVISIONS.  NOTWITHSTANDING ANY
PROVISION HEREIN TO THE CONTRARY, THE RIGHTS AND OBLIGATIONS OF THE PARTIES SET
FORTH IN SECTIONS 5.8(B), 6, 7.2, 7.4, 8.3, 8.4, 8.5, 9.3, 10 AND 11 AS WELL AS
ANY RIGHTS OR OBLIGATIONS OTHERWISE ACCRUED HEREUNDER (INCLUDING ANY ACCRUED
PAYMENT OBLIGATIONS), SHALL SURVIVE THE EXPIRATION OR TERMINATION OF THE TERM OF
THIS AGREEMENT. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, CENTOCOR SHALL
HAVE NO OBLIGATION TO MAKE ANY MILESTONE OR ROYALTY PAYMENT TO IMMUNOGEN THAT
HAS NOT ACCRUED PRIOR TO THE EFFECTIVE DATE OF ANY TERMINATION OF THIS
AGREEMENT, BUT SHALL REMAIN LIABLE FOR ALL SUCH PAYMENT OBLIGATIONS ACCRUING
PRIOR TO THE EFFECTIVE DATE OF SUCH TERMINATION.

 

9.                                      REPRESENTATIONS AND WARRANTIES

 

9.1                               IMMUNOGEN REPRESENTATIONS.  IMMUNOGEN
REPRESENTS AND WARRANTS TO CENTOCOR THAT:  (A) THE EXECUTION AND DELIVERY OF
THIS AGREEMENT AND THE PERFORMANCE OF THE TRANSACTIONS CONTEMPLATED HEREBY HAVE
BEEN DULY AUTHORIZED BY ALL APPROPRIATE IMMUNOGEN CORPORATE ACTION; (B) THIS
AGREEMENT IS A LEGAL AND VALID OBLIGATION BINDING UPON IMMUNOGEN AND ENFORCEABLE
IN ACCORDANCE WITH ITS TERMS, AND THE EXECUTION, DELIVERY AND PERFORMANCE OF
THIS AGREEMENT BY THE PARTIES DOES NOT CONFLICT WITH ANY AGREEMENT, INSTRUMENT
OR UNDERSTANDING TO WHICH IMMUNOGEN IS A PARTY OR BY WHICH IT IS BOUND; (C)
IMMUNOGEN HAS THE FULL RIGHT AND LEGAL CAPACITY TO GRANT THE LICENSES AND RIGHTS
TO CENTOCOR PURSUANT TO SECTION 2 ABOVE WITHOUT VIOLATING THE RIGHTS OF ANY
THIRD PARTY; (D) TO IMMUNOGEN’S KNOWLEDGE, NO PATENT RIGHTS WITHIN THE LICENSED
PATENT RIGHTS ARE INVALID OR UNENFORCEABLE AND AS OF THE EFFECTIVE DATE NO
PATENTS WITHIN THE LICENSED PATENT RIGHTS HAVE EXPIRED; (E) AS OF THE EFFECTIVE
DATE, IMMUNOGEN HAS RECEIVED NO NOTICE FROM A THIRD PARTY CLAIMING THAT THE
EXERCISE OF THE LICENSE GRANTED HEREUNDER TO CENTOCOR WILL INFRINGE THE ISSUED
PATENTS OF ANY SUCH THIRD PARTY; (F) TO THE EXTENT IT UNDERTAKES TO MANUFACTURE
PRECLINICAL MATERIALS UNDER THIS AGREEMENT, IT SHALL COMPLY WITH ALL STATUTES
AND LAWS RELATING TO THE MANUFACTURE AND SUPPLY OF SUCH PRECLINICAL MATERIALS
BEING SUPPLIED HEREUNDER, INCLUDING, WITHOUT LIMITATION, THOSE ENFORCED BY THE
FDA; AND (G) IMMUNOGEN HAS READ THE [**************] ON THE [********] OF
[********] (THE “POLICY”)

 

 

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

 

49

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

 

ATTACHED HERETO AS SCHEDULE F AND AGREES, IN RELATION TO PRECLINICAL MATERIALS
MANUFACTURED AND SUPPLIED BY IMMUNOGEN HEREUNDER, TO [***************] ONLY AS
PERMITTED BY THE POLICY.

 

9.2                               CENTOCOR REPRESENTATIONS.  CENTOCOR REPRESENTS
AND WARRANTS TO IMMUNOGEN THAT:  (A) THE EXECUTION AND DELIVERY OF THIS
AGREEMENT AND THE PERFORMANCE OF THE TRANSACTIONS CONTEMPLATED HEREBY HAVE BEEN
DULY AUTHORIZED BY ALL APPROPRIATE CENTOCOR CORPORATE ACTION; AND (B) THIS
AGREEMENT IS A LEGAL AND VALID OBLIGATION BINDING UPON CENTOCOR AND ENFORCEABLE
IN ACCORDANCE WITH ITS TERMS, AND THE EXECUTION, DELIVERY AND PERFORMANCE OF
THIS AGREEMENT BY THE PARTIES DOES NOT CONFLICT WITH ANY AGREEMENT, INSTRUMENT
OR UNDERSTANDING TO WHICH CENTOCOR IS A PARTY OR BY WHICH IT IS BOUND.

 

9.3                               NO WARRANTIES.

 

(A)                                   NOTHING IN THIS AGREEMENT IS OR SHALL BE
CONSTRUED AS:

 

(I)                                     A WARRANTY OR REPRESENTATION BY
IMMUNOGEN AS TO THE VALIDITY OR SCOPE OF ANY PATENT APPLICATION OR PATENT WITHIN
THE LICENSED PATENT RIGHTS;

 

(II)                                  A WARRANTY OR REPRESENTATION THAT ANYTHING
MADE, USED, SOLD OR OTHERWISE DISPOSED OF UNDER ANY LICENSE GRANTED IN THIS
AGREEMENT IS OR WILL BE FREE FROM INFRINGEMENT OF PATENTS, COPYRIGHTS, AND OTHER
RIGHTS OF THIRD PARTIES.

 

(B)                                  EXCEPT AS EXPRESSLY SET FORTH IN THIS
AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF
ANY KIND, EITHER EXPRESS OR IMPLIED.  WITHOUT LIMITING THE FOREGOING, THERE ARE
NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE, THAT ANY LICENSED PRODUCT WILL BE SUCCESSFULLY DEVELOPED OR MARKETED,
OR THAT THE DEVELOPMENT, MANUFACTURE, SALE, IMPORTATION OR USE OF THE LICENSED
PRODUCT(S) WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER RIGHTS,
OR ANY OTHER EXPRESS OR IMPLIED WARRANTIES.

 

 

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

 

50

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

 

10.                               INDEMNIFICATION; LIABILITY

 

10.1                        INDEMNIFICATION.

 

(A)                                   CENTOCOR INDEMNITY.  SUBJECT TO
SECTION 10.1(B) BELOW AND THE REMAINDER OF THIS SECTION 10, CENTOCOR SHALL
INDEMNIFY, DEFEND AND HOLD HARMLESS IMMUNOGEN, ITS AFFILIATES AND THEIR
RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES, AND AGENTS AND THEIR RESPECTIVE
SUCCESSORS, HEIRS AND ASSIGNS (THE “IMMUNOGEN INDEMNITEES”), FROM AND AGAINST
ANY LIABILITY, DAMAGE, LOSS OR EXPENSE (INCLUDING REASONABLE ATTORNEYS’ FEES AND
EXPENSES OF LITIGATION) INCURRED BY OR IMPOSED UPON SUCH IMMUNOGEN INDEMNITEES,
OR ANY OF THEM, IN CONNECTION WITH ANY THIRD PARTY CLAIMS, SUITS, ACTIONS,
DEMANDS OR JUDGMENTS, INCLUDING, WITHOUT LIMITATION, PERSONAL INJURY AND PRODUCT
LIABILITY MATTERS, THAT ARISE OUT OF OR RELATE TO (I) ANY ACTIONS OR OMISSIONS
OF CENTOCOR OR ANY AFFILIATE OR SUBLICENSEE OF CENTOCOR IN THE DEVELOPMENT,
TESTING, PRODUCTION, MANUFACTURE, SUPPLY, PROMOTION, IMPORT, SALE OR USE BY ANY
PERSON OF ANY LICENSED PRODUCT (OR ANY COMPONENT THEREOF) MANUFACTURED OR SOLD
BY CENTOCOR OR ANY AFFILIATE OR SUBLICENSEE OF CENTOCOR UNDER THIS AGREEMENT,
(II) ANY MATERIAL BREACH OF THIS AGREEMENT BY CENTOCOR OR (III) THE GROSS
NEGLIGENCE OR WILLFUL MISCONDUCT ON THE PART OF CENTOCOR EXCEPT TO THE EXTENT OF
IMMUNOGEN’S RESPONSIBILITY THEREFOR UNDER SECTION 10.1(B) BELOW.

 

(B)                                  IMMUNOGEN INDEMNITY.  SUBJECT TO
SECTION 10.1(A) ABOVE AND THE REMAINDER OF THIS SECTION 10, IMMUNOGEN SHALL
INDEMNIFY, DEFEND AND HOLD HARMLESS CENTOCOR ITS AFFILIATES AND THEIR RESPECTIVE
DIRECTORS, OFFICERS, EMPLOYEES, AND AGENTS, AND THEIR RESPECTIVE SUCCESSORS,
HEIRS AND ASSIGNS (THE “CENTOCOR INDEMNITEES”), FROM AND AGAINST ANY LIABILITY,
DAMAGE, LOSS OR EXPENSE (INCLUDING REASONABLE ATTORNEYS’ FEES AND EXPENSES OF
LITIGATION) INCURRED BY OR IMPOSED UPON SUCH CENTOCOR INDEMNITEES, OR ANY OF
THEM, IN CONNECTION WITH ANY THIRD PARTY CLAIMS, SUITS, ACTIONS, DEMANDS OR
JUDGMENTS, INCLUDING, WITHOUT LIMITATION, PERSONAL INJURY AND PRODUCT LIABILITY
MATTERS, THAT ARISE OUT OF OR RELATE TO (I) ANY MATERIAL BREACH OF THIS
AGREEMENT BY IMMUNOGEN, OR (II) THE GROSS NEGLIGENCE OR WILLFUL MISCONDUCT ON
THE PART OF IMMUNOGEN, EXCEPT TO THE EXTENT OF CENTOCOR’S RESPONSIBILITY
THEREFOR UNDER SECTION 10.1(A) ABOVE.

 

10.2                        INDEMNIFICATION PROCEDURES.  IN THE EVENT THAT ANY
INDEMNITEE IS SEEKING

 

 

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

 

51

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

 

INDEMNIFICATION UNDER SECTION 10.1 ABOVE FROM A PARTY (THE “INDEMNIFYING
PARTY”), THE OTHER PARTY SHALL NOTIFY THE INDEMNIFYING PARTY OF SUCH CLAIM WITH
RESPECT TO SUCH INDEMNITEE AS SOON AS REASONABLY PRACTICABLE AFTER THE
INDEMNITEE RECEIVES NOTICE OF THE CLAIM, AND THE PARTY (ON BEHALF OF ITSELF AND
SUCH INDEMNITEE) SHALL PERMIT THE INDEMNIFYING PARTY TO ASSUME DIRECTION AND
CONTROL OF THE DEFENSE OF THE CLAIM (INCLUDING THE RIGHT TO SETTLE THE CLAIM
SOLELY FOR MONETARY CONSIDERATION) AND SHALL COOPERATE AS REQUESTED (AT THE
EXPENSE OF THE INDEMNIFYING PARTY) IN THE DEFENSE OF THE CLAIM.

 

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

 

10.4                        INSURANCE PROCEEDS. ANY INDEMNIFICATION HEREUNDER
SHALL BE MADE NET OF ANY INSURANCE PROCEEDS RECOVERED BY THE INDEMNIFIED PARTY;
PROVIDED, HOWEVER, THAT IF, FOLLOWING THE PAYMENT TO THE INDEMNIFIED PARTY OF
ANY AMOUNT UNDER THIS ARTICLE 10, SUCH INDEMNIFIED PARTY RECOVERS ANY INSURANCE
PROCEEDS IN RESPECT OF THE CLAIM FOR WHICH SUCH INDEMNIFICATION PAYMENT WAS
MADE, THE INDEMNIFIED PARTY SHALL PROMPTLY PAY AN AMOUNT EQUAL TO THE AMOUNT OF
SUCH PROCEEDS (BUT NOT EXCEEDING THE AMOUNT OF SUCH INDEMNIFICATION PAYMENT) TO
THE INDEMNIFYING PARTY.

 

10.5                        INSURANCE. CENTOCOR AND IMMUNOGEN SHALL USE ALL
COMMERCIALLY REASONABLE EFFORTS TO MAINTAIN INSURANCE, INCLUDING PRODUCT
LIABILITY INSURANCE, WITH RESPECT TO ITS ACTIVITIES HEREUNDER.  SUCH INSURANCE
SHALL BE IN SUCH AMOUNTS AND SUBJECT TO SUCH DEDUCTIBLES AS THE PARTIES MAY
AGREE, BASED UPON STANDARDS PREVAILING IN THE INDUSTRY AT THE TIME.  CENTOCOR
MAY SATISFY ITS OBLIGATIONS UNDER THIS SECTION THROUGH SELF-INSURANCE TO THE
SAME EXTENT.

 

 

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

 

52

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

 

11.                               MISCELLANEOUS

 

11.1                        ENTIRE AGREEMENT; AMENDMENTS.  THIS IS THE ENTIRE
AGREEMENT BETWEEN THE PARTIES WITH RESPECT TO THE SUBJECT MATTER HEREIN, AND
SUPERSEDES ANY PRIOR AGREEMENTS, UNDERSTANDINGS, NEGOTIATIONS OR CORRESPONDENCE
BETWEEN THE PARTIES RESPECTING THE SUBJECT MATTER HEREOF, WHETHER WRITTEN OR
VERBAL (INCLUDING, WITHOUT LIMITATION, THE MTA, AND THAT CERTAIN CONFIDENTIALITY
AGREEMENT EFFECTIVE [***************].  NO MODIFICATION OR OTHER AMENDMENT OF
THIS AGREEMENT SHALL BE EFFECTIVE UNLESS IN WRITING AND SIGNED BY A FULLY
AUTHORIZED REPRESENTATIVE OF EACH PARTY.

 

11.2                        WAIVER.  THE TERMS OR CONDITIONS OF THIS AGREEMENT
MAY BE WAIVED ONLY BY A WRITTEN INSTRUMENT EXECUTED BY A DULY AUTHORIZED
REPRESENTATIVE OF THE PARTY WAIVING COMPLIANCE.  THE FAILURE OF EITHER PARTY AT
ANY TIME OR TIMES TO REQUIRE PERFORMANCE OF ANY PROVISION HEREOF SHALL IN NO
MANNER AFFECT ITS RIGHTS AT A LATER TIME TO ENFORCE THE SAME.  NO WAIVER BY
EITHER PARTY OF ANY CONDITION OR TERM SHALL BE DEEMED AS A CONTINUING WAIVER OF
SUCH CONDITION OR TERM OR OF ANOTHER CONDITION OR TERM.

 

11.3                        GOVERNING LAW.  THIS AGREEMENT WILL BE CONSTRUED,
INTERPRETED AND APPLIED IN ACCORDANCE WITH THE LAWS OF THE COMMONWEALTH OF
MASSACHUSETTS APPLICABLE TO CONTRACTS ENTERED INTO AND TO BE PERFORMED ENTIRELY
WITHIN THE COMMONWEALTH OF MASSACHUSETTS WITHOUT GIVING EFFECT TO ANY CHOICE OF
LAW PRINCIPLES THAT WOULD REQUIRE THE APPLICATION OF THE LAWS OF A DIFFERENT
STATE.  NOTWITHSTANDING THE FOREGOING, ANY DISPUTE, CONTROVERSY OR CLAIM
RELATING TO THE SCOPE, VALIDITY, ENFORCEABILITY OR INFRINGEMENT OF ANY PATENT
RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS SHALL BE GOVERNED BY THE LAW OF THE
TERRITORY IN WHICH SUCH PATENT RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHTS WERE
GRANTED OR AROSE.

 

11.4                        NOTICES.  ANY NOTICES, REQUESTS, DELIVERIES,
APPROVALS OR CONSENTS REQUIRED OR PERMITTED TO BE GIVEN UNDER THIS AGREEMENT TO
CENTOCOR OR IMMUNOGEN SHALL BE IN WRITING AND SHALL BE PERSONALLY DELIVERED OR
SENT BY TELECOPY (WITH MACHINE CONFIRMATION OF TRANSMISSION) OR BY OVERNIGHT
COURIER PROVIDING EVIDENCE OF RECEIPT OR CERTIFIED MAIL, RETURN RECEIPT
REQUESTED, POSTAGE PREPAID, IN EACH CASE TO THE RESPECTIVE ADDRESS SPECIFIED
BELOW (OR TO SUCH ADDRESS AS MAY BE SPECIFIED IN WRITING TO THE OTHER PARTY
HERETO):

 

 

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

 

53

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

 

If to ImmunoGen:

 

ImmunoGen, Inc.

 

 

128 Sidney Street

 

 

Cambridge, MA 02139

 

 

Attn: Chief Executive Officer

 

 

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

 

 

 

with a copy to

 

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

 

 

One Financial Center

 

 

Boston, MA 02111

 

 

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

 

 

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

 

 

 

If to Centocor:

 

Centocor, Inc.

 

 

200 Great Valley Parkway

 

 

Malvern, Pennsylvania 19355

 

 

Attn: President

 

 

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

 

 

 

With copy to:

 

Office of General Counsel

 

 

Johnson & Johnson

 

 

One Johnson & Johnson Plaza

 

 

New Brunswick, New Jersey 08933

 

 

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

 

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

 

11.5                        NO IMPLIED LICENSES.  EXCEPT AS EXPRESSLY SET FORTH
ELSEWHERE IN THIS AGREEMENT, NEITHER PARTY GRANTS TO THE OTHER PARTY ANY RIGHT
OR LICENSE TO ANY OF ITS INTELLECTUAL PROPERTY.

 

11.6                        HEADINGS.  SECTION AND SUBSECTION HEADINGS ARE
INSERTED FOR CONVENIENCE OF REFERENCE ONLY AND DO NOT FORM PART OF THIS
AGREEMENT.

 

11.7                        ASSIGNMENT.  THIS AGREEMENT MAY NOT BE ASSIGNED BY
EITHER PARTY WITHOUT THE CONSENT OF THE OTHER, EXCEPT THAT EACH PARTY MAY,
WITHOUT SUCH CONSENT, ASSIGN THIS AGREEMENT AND THE RIGHTS, OBLIGATIONS AND
INTERESTS OF SUCH PARTY, IN WHOLE OR IN PART, TO ANY OF ITS AFFILIATES, TO ANY
PURCHASER OF ALL OR SUBSTANTIALLY ALL OF ITS ASSETS IN THE LINE OF BUSINESS TO
WHICH THIS AGREEMENT PERTAINS OR TO ANY SUCCESSOR CORPORATION RESULTING FROM ANY
MERGER OR CONSOLIDATION

 

 

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

 

54

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

 

OF SUCH PARTY WITH OR INTO SUCH CORPORATIONS.

 

11.8                        FORCE MAJEURE.  NEITHER PARTY SHALL BE LIABLE FOR
FAILURE OF OR DELAY IN PERFORMING OBLIGATIONS SET FORTH IN THIS AGREEMENT, AND
NEITHER SHALL BE DEEMED IN BREACH OF ITS OBLIGATIONS, IF SUCH FAILURE OR DELAY
IS DUE TO NATURAL DISASTERS OR ANY CAUSES BEYOND THE REASONABLE CONTROL OF SUCH
PARTY.  IN EVENT OF SUCH FORCE MAJEURE, THE PARTY AFFECTED THEREBY SHALL USE
REASONABLE EFFORTS TO CURE OR OVERCOME THE SAME AND RESUME PERFORMANCE OF ITS
OBLIGATIONS HEREUNDER.

 

11.9                        CONSTRUCTION.  THE PARTIES HERETO ACKNOWLEDGE AND
AGREE THAT:  (A) EACH PARTY AND ITS COUNSEL REVIEWED AND NEGOTIATED THE TERMS
AND PROVISIONS OF THIS AGREEMENT AND HAVE CONTRIBUTED TO ITS REVISION; (B) THE
RULE OF CONSTRUCTION TO THE EFFECT THAT ANY AMBIGUITIES ARE RESOLVED AGAINST THE
DRAFTING PARTY SHALL NOT BE EMPLOYED IN THE INTERPRETATION OF THIS AGREEMENT;
AND (C) THE TERMS AND PROVISIONS OF THIS AGREEMENT SHALL BE CONSTRUED FAIRLY AS
TO EACH PARTY HERETO AND NOT IN A FAVOR OF OR AGAINST ANY PARTY, REGARDLESS OF
WHICH PARTY WAS GENERALLY RESPONSIBLE FOR THE PREPARATION OF THIS AGREEMENT.

 

11.10                 SEVERABILITY.  IF ANY PROVISION(S) OF THIS AGREEMENT ARE
OR BECOME INVALID, ARE RULED ILLEGAL BY ANY COURT OF COMPETENT JURISDICTION OR
ARE DEEMED UNENFORCEABLE UNDER THEN CURRENT APPLICABLE LAW FROM TIME TO TIME IN
EFFECT DURING THE TERM HEREOF, IT IS THE INTENTION OF THE PARTIES THAT THE
REMAINDER OF THIS AGREEMENT SHALL NOT BE AFFECTED THEREBY PROVIDED THAT A
PARTY’S RIGHTS UNDER THIS AGREEMENT ARE NOT MATERIALLY AFFECTED.  THE PARTIES
HERETO COVENANT AND AGREE TO RENEGOTIATE ANY SUCH TERM, COVENANT OR APPLICATION
THEREOF IN GOOD FAITH IN ORDER TO PROVIDE A REASONABLY ACCEPTABLE ALTERNATIVE TO
THE TERM, COVENANT OR CONDITION OF THIS AGREEMENT OR THE APPLICATION THEREOF
THAT IS INVALID, ILLEGAL OR UNENFORCEABLE, IT BEING THE INTENT OF THE PARTIES
THAT THE BASIC PURPOSES OF THIS AGREEMENT ARE TO BE EFFECTUATED.

 

11.11                 STATUS.  NOTHING IN THIS AGREEMENT IS INTENDED OR SHALL BE
DEEMED TO CONSTITUTE A PARTNER, AGENCY, EMPLOYER-EMPLOYEE, OR JOINT VENTURE
RELATIONSHIP BETWEEN THE PARTIES.

 

11.12                 DISPUTE RESOLUTION.  THE PARTIES RECOGNIZE THAT A BONA
FIDE DISPUTE AS TO CERTAIN MATTERS MAY FROM TIME TO TIME ARISE DURING THE TERM
OF THIS AGREEMENT RELATING TO EITHER PARTY’S RIGHTS AND/OR OBLIGATIONS HEREUNDER
OR OTHERWISE RELATING TO THE VALIDITY, ENFORCEABILITY OR PERFORMANCE OF THIS
AGREEMENT, INCLUDING DISPUTES RELATING TO ALLEGED BREACH OR TERMINATION OF

 

 

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

 

55

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

 

THIS AGREEMENT BUT EXCLUDING ANY DETERMINATION OF THE VALIDITY OF THE PARTIES’
PATENTS (HEREINAFTER, A “DISPUTE”).  IN THE EVENT OF THE OCCURRENCE OF ANY SUCH
DISPUTE, THE PARTIES SHALL, BY WRITTEN NOTICE TO THE OTHER PARTY, HAVE SUCH
DISPUTE REFERRED TO THEIR RESPECTIVE SENIOR OFFICERS DESIGNATED BELOW (AND TO
ANY DESIGNATED OFFICER OF A CENTOCOR SUBLICENSEE, IF SUCH DISPUTE INVOLVES SUCH
SUBLICENSEE), FOR ATTEMPTED RESOLUTION BY GOOD FAITH NEGOTIATIONS COMMENCING
PROMPTLY AFTER SUCH NOTICE IS RECEIVED.  SAID DESIGNATED SENIOR OFFICIALS OF THE
PARTIES ARE AS FOLLOWS:

 

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

For ImmunoGen:    Chief Executive Officer.

 

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

 

11.13                 FURTHER ASSURANCES.  EACH PARTY AGREES TO EXECUTE,
ACKNOWLEDGE AND DELIVER SUCH FURTHER INSTRUMENTS, AND TO DO ALL OTHER SUCH ACTS,
AS MAY BE NECESSARY OR APPROPRIATE IN ORDER TO CARRY OUT THE PURPOSES AND INTENT
OF THIS AGREEMENT.

 

11.14                 COUNTERPARTS.  THIS AGREEMENT MAY BE EXECUTED
SIMULTANEOUSLY IN ONE OR MORE COUNTERPARTS, EACH OF WHICH SHALL BE DEEMED AN
ORIGINAL, BUT ALL OF WHICH TOGETHER SHALL CONSTITUTE ONE AND THE SAME
INSTRUMENT.

 

 

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

 

56

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

 

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

 

 

CENTOCOR, INC.

IMMUNOGEN, INC.

 

 

 

 

 

 

 

 

By:

/s/ Jay P. Siegel

 

By:  

/s/ Mitchel Sayare/

 

 

 

 

 

Name:

Jay Siegel

 

 

Mitchel Sayare

 

 

 

 

 

Title:

President, Centocor Research

 

Title:

CEO

 

 

Development and Supply, Inc.

 

 

 

 

 

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

 

57

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

 

APPENDIX 3.1

 

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

 

YEAR 2005 (AND 2006)

 

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

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

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

 

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

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

 

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

 

[******]

 

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

 

[******]

 

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

 

[******]

 

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

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

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

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

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

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

 

[******]

 

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

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

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

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

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

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

 

[******]

 

3.1-1

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

 

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

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

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

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

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

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

 

[******]

 

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

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

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

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

 

[******]

 

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

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

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

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

 

[******]

 

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

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

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

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

 

[******]

 

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

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

 

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

 

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

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

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

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

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

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

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

 

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

 

3.1-2

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

3.1-3

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

 

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

 

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

 

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

 

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

 

3.1-4

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

 

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

 

[********************************************************************************************************
***************************************************************]:

 

•    [**************************************************************************************************
**************************************************************************************************
**************************************************************************************************
**************************************************************************************************
**************************************************************************************************
**************************************************************************************************
**************************************************************************************************
**************************************************************************************************
**************************************************************************************************
**************************************************************************************************
**************************************************************************************************
**********************************************************************************].

 

[*********************************************************************************************************
**********************************************************************************************************
****************************************************************************************************]:

 

•    [**************************************************************************************************
**************************************************************************************************
**************************************************************************************************
**************************************************************************************************
**************************************************************************************************
**************************************************************************************************
**************************************************************************************************
**************************************************************************************************
**************************************************************************************************
********************************************].

 

3.1-5

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

 

SCHEDULE A

 

LICENSED PATENT RIGHTS

 

MAYTANSINOID CONJUGATES

(Cytotoxic agents comprising maytansinoids and their therapeutic use)

 

Atty. Ref. No.

 

Country

 

Appl. No.

 

Filing Date

 

Priority Date

 

Patent No.

 

Issue Date

 

Expiry Date

A-5567*

 

U.S.

 

07/426,247

 

25-Oct-89

 

 

 

Abandoned

 

 

 

 

A-5567-1*

 

U.S.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Rule 62 Cont.

 

07/911,380

 

13-Jul-92

 

25-Oct-89

 

5,208,020

 

04-May-93

 

04-May-10

A-6190*

 

U.S. Div.

 

07/986,578

 

07-Dec-92

 

25-Oct-89

 

5,416,064

 

16-May-95

 

16-May-12

F89903

 

Europe

 

0 90 311 590.5

 

23-Oct-90

 

25-Oct-89

 

0 425 235 B1

 

25-Sep-96

 

23-Oct-10

F89903

 

AT

 

0 90 311 590.5

 

23-Oct-90

 

25-Oct-89

 

0 425 235 B1

 

25-Sep-96

 

23-Oct-10

F89903

 

BE

 

0 90 311 590.5

 

23-Oct-90

 

25-Oct-89

 

0 425 235 B1

 

25-Sep-96

 

23-Oct-10

F89903

 

CH

 

0 90 311 590.5

 

23-Oct-90

 

25-Oct-89

 

0 425 235 B1

 

25-Sep-96

 

23-Oct-10

F89903

 

DE

 

0 90 311 590.5

 

23-Oct-90

 

25-Oct-89

 

690 28678.3-3-08

 

25-Sep-96

 

23-Oct-10

F89903

 

DK

 

0 90 311 590.5

 

23-Oct-90

 

25-Oct-89

 

0 425 235 B1

 

25-Sep-96

 

23-Oct-10

F89903

 

ES

 

0 90 311 590.5

 

23-Oct-90

 

25-Oct-89

 

0 425 235 B1

 

25-Sep-96

 

23-Oct-10

F89903

 

FR

 

0 90 311 590.5

 

23-Oct-90

 

25-Oct-89

 

0 425 235 B1

 

25-Sep-96

 

23-Oct-10

F89903

 

GB

 

0 90 311 590.5

 

23-Oct-90

 

25-Oct-89

 

0 425 235 B1

 

25-Sep-96

 

23-Oct-10

F89903

 

IT

 

0 90 311 590.5

 

23-Oct-90

 

25-Oct-89

 

0 425 235 B1

 

25-Sep-96

 

23-Oct-10

F89903

 

LI

 

0 90 311 590.5

 

23-Oct-90

 

25-Oct-89

 

0 425 235 B1

 

25-Sep-96

 

23-Oct-10

F89903

 

LU

 

0 90 311 590.5

 

23-Oct-90

 

25-Oct-89

 

0 425 235 B1

 

25-Sep-96

 

23-Oct-10

F89903

 

NL

 

0 90 311 590.5

 

23-Oct-90

 

25-Oct-89

 

0 425 235 B1

 

25-Sep-96

 

23-Oct-10

F89903

 

SE

 

0 90 311 590.5

 

23-Oct-90

 

25-Oct-89

 

0 425 235 B1

 

25-Sep-96

 

23-Oct-10

F89902

 

Canada

 

2,026,147-1

 

25-Sep-90

 

25-Oct-89

 

Pending

 

 

 

 

F89904

 

Japan

 

2-290,625

 

25-Oct-90

 

25-Oct-89

 

3155998

 

09-Feb-01

 

25-Oct-10

 

MAYTANSINOID PROCESS

(Process for the preparation and purification of thiol-containing maytansinoids)

 

Atty. Ref. No.

 

Country

 

Appl. No.

 

Filing Date

 

Priority Date

 

Patent No.

 

Issue Date

 

Expiry Date

A7752*

 

U.S.

 

09/641,348

 

18-Aug-00

 

 

 

6,333,410 B1

 

25-Dec-01

 

18-Aug-20

A8451

 

U.S.

 

10/410,143

 

10-Apr-03

 

18-Aug-00

 

Re-Issue

 

 

 

 

A8707

 

U.S. (Div)

 

10/758,264

 

16-Jan-04

 

19-Aug-00

 

Pending

 

 

 

 

F145222

 

PCT

 

PCT/US01/10816

 

26-Apr-01

 

18-Aug-00

 

Pub. No. WO 02/16368 A1 02/28/02)

 

 

 

 

F145201

 

Australia

 

53118/01

 

26-Apr-01

 

18-Aug-00

 

763107

 

30-Oct-03

 

26-Apr-21

F145202

 

Canada

 

2373554

 

26-Apr-01

 

18-Aug-00

 

Pending

 

 

 

 

F145203

 

Europe

 

01926594-1

 

26-Apr-01

 

18-Aug-00

 

Pending

 

 

 

 

F145204

 

Japan

 

2002-521468

 

26-Apr-01

 

18-Aug-00

 

Pending

 

 

 

 

F145239

 

Hong Kong

 

03108241.7

 

13-Nov-03

 

18-Aug-00

 

Pending

 

 

 

 

 

A-1

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

 

MAYTANSINOID CONJUGATE PROCESS

(Methods for the preparation of cytotoxic conjugates of maytansinoids and cell
binding agents)

 

Atty. Ref. No.

 

Country

 

Appl. No.

 

Filing Date

 

Priority Date

 

Patent No.

 

Issue Date

 

Expiry Date

A7970*

 

U.S.

 

09/867,598

 

31-May-01

 

 

 

6,441,163 B1

 

27-Aug-02

 

31-May-21

A8369

 

U.S.

 

10/161,651

 

05-Jun-02

 

31-May-01

 

Pending

 

 

 

 

F154222

 

PCT

 

PCT/US02/03378

 

14-Feb-02

 

31-May-01

 

Pub. No. WO 02/098883 A1 (12/12/02)

 

 

 

 

F154201

 

Australia

 

2002251880

 

14-Feb-02

 

31-May-01

 

Pending

 

 

 

 

F154202

 

Canada

 

2,417,858

 

14-Feb-02

 

31-May-01

 

Pending

 

 

 

 

F154203

 

Europe

 

02720913.9

 

14-Feb-02

 

31-May-01

 

Pub. No. 1390370 (2/25/04)

 

 

 

 

F154204

 

Japan

 

2003-502004

 

14-Feb-02

 

31-May-01

 

Pending

 

 

 

 

F154221

 

New Zealand

 

523655

 

14-Feb-02

 

31-May-01

 

Pending

 

 

 

 

F154239

 

Hong Kong

 

4103250.5

 

14-Feb-02

 

31-May-01

 

Pending

 

 

 

 

 

ANTI-ErbB ANTIBODY-MAYTANSINOID CONJUGATES (“Genentech Application”)

(Methods of treatment using anti-ErbB antibody-maytansinoid conjugates)

 

Atty. Ref. No.

 

Country

 

Appl. No.

 

Filing Date

 

Priority Date

 

Patent No.

 

Issue Date

 

Expiry Date

?

 

U.S.

 

60/141,316

 

25-Jun-99

 

 

 

Provisional

 

 

 

 

PR1801R1

 

U.S.

 

60/189,844

 

16-Mar-00

 

 

 

Provisional

 

 

 

 

PR1801

 

U.S.

 

60/329,563

 

23-Jun-00

 

 

 

Provisional

 

 

 

 

PR1801-2

 

U.S.

 

60/238,327

 

05-Oct-00

 

 

 

Provisional

 

 

 

 

P1801R1

 

U.S./CIP

 

09/602,530

 

23-Jun-00

 

 

 

Pending

 

 

 

 

P1801R2

 

U.S.

 

09/811,123

 

16-Mar-01

 

16-Mar-00
23-Jun-00
05-Oct-00

 

Pub. No. 2002-0001587 (1/3/02)

 

 

 

 

P1801R1

 

PCT

 

PCT/US00/17229

 

23-Jun-00

 

25-Jun-99
16-Mar-00

 

Pub. No. WO 0100244 (1/4/01)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

P1801R1

 

Australia

 

56329/00

 

23-Jun-00

 

 

 

Pending

 

 

 

 

P1801R1

 

Brazil

 

PI0012196.7

 

23-Jun-00

 

 

 

Pending

 

 

 

 

P1801R1

 

Canada

 

2370466

 

23-Jun-00

 

 

 

Pending

 

 

 

 

P1801R1

 

China

 

811782.9

 

23-Jun-00

 

 

 

Pending

 

 

 

 

P1801R1

 

Europe

 

941649.6

 

23-Jun-00

 

 

 

EP 1191944 A2 (1/4/01)

 

 

 

 

P1801R1

 

Hungary

 

0201616

 

23-Jun-00

 

 

 

Pending

 

 

 

 

P1801R1

 

Israel

 

147241

 

23-Jun-00

 

 

 

Pending

 

 

 

 

P1801R1

 

Japan

 

505951/01

 

23-Jun-00

 

 

 

Pending

 

 

 

 

P1801R1

 

Korea

 

10-2001-7016486

 

23-Jun-00

 

 

 

Pending

 

 

 

 

P1801R1

 

Mexico

 

PA/a/2001/013240

 

23-Jun-00

 

 

 

Pending

 

 

 

 

P1801R1

 

New Zealand

 

515975

 

23-Jun-00

 

 

 

51595

 

10-May-04

 

23-Jun-20

P1801R1

 

Poland

 

P352678

 

23-Jun-00

 

 

 

Pending

 

 

 

 

P1801R1

 

So. Africa

 

9768/01

 

23-Jun-00

 

 

 

Pending

 

 

 

 

 

A-2

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

 

PF4-4 STRAIN

(Mutant Actinosynnema pretiosum strain with increased maytansinoid production)

 

Atty. Ref. No.

 

Country

 

Appl. No.

 

Filing Date

 

Priority Date

 

Patent No.

 

Issue Date

 

Expiry Date

A8275

 

U.S.

 

10/057,561

 

29-Jan-02

 

 

 

6,790,954

 

14-Sep-04

 

29-Jan-22

A8802

 

U.S. (Div)

 

10/898,169

 

26-Jul-04

 

29-Jan-02

 

Pending

 

 

 

 

F163522

 

PCT

 

PCT/US03/00026

 

15-Jan-03

 

29-Jan-02

 

Pub. No. WO 03/064610 A2 (8/7/03)

 

 

 

 

F163501

 

Australia

 

20033238752

 

15-Jan-03

 

29-Jan-02

 

Pending

 

 

 

 

F163502

 

Canada

 

No number yet

 

15-Jan-03

 

29-Jan-02

 

Pending

 

 

 

 

F163503

 

Europe

 

03734944.6

 

15-Jan-03

 

29-Jan-02

 

Pending

 

 

 

 

F163504

 

Japan

 

2003-564206

 

15-Jan-03

 

29-Jan-02

 

Pending

 

 

 

 

F163521

 

New Zealand

 

532831

 

15-Jan-03

 

29-Jan-02

 

Pending

 

 

 

 

 

METHODS FOR THE PRODUCTION OF ANSAMITOCINS (Fermentation Process)

 

Atty. Ref. No.

 

Country

 

Appl. No.

 

Filing Date

 

Priority Date

 

Patent No.

 

Issue Date

 

Expiry Date

P8588

 

U.S.

 

60/468,638

 

08-May-03

 

 

 

Provisional

 

 

 

 

A8588

 

U.S.

 

10/840,768

 

07-May-04

 

08-May-03

 

Pending

 

 

 

 

F174522

 

PCT

 

PCT/US04/01300

 

10-May-04

 

08-May-03

 

Pending

 

 

 

 

 

IMPROVED CYTOTOXIC AGENTS COMPRISING NEW MAYTANSINOIDS (DM4)

 

Atty. Ref. No.

 

Country

 

Appl. No.

 

Filing Date

 

Priority Date

 

Patent No.

 

Issue Date

 

Expiry Date

P8576

 

U.S.

 

60/471,739

 

20-May-03

 

 

 

Provisional

 

 

 

 

A8576

 

U.S.

 

10/849,136

 

20-May-04

 

20-May-03

 

Pub. No. 2004/0235840 A1 (11/25/04)

 

 

 

 

F177222

 

PCT

 

PCT/US04/013314

 

20-May-04

 

20-May-03

 

Pending

 

 

 

 

 

DRUG CONJUGATE COMPOSITION (Formulation)

 

Atty. Ref. No.

 

Country

 

Appl. No.

 

Filing Date

 

Priority Date

 

Patent No.

 

Issue Date

 

Expiry Date

LVM 219992

 

U.S.

 

60/470,550

 

14-May-03

 

 

 

Provisional

 

 

 

 

LVM 228669

 

U.S.

 

10/846,129

 

14-May-04

 

14-May-03

 

Pending

 

 

 

 

LVM 228670

 

PCT

 

PCT/US04/15376

 

14-May-04

 

14-May-03

 

Pending

 

 

 

 

 

SMCC CONJUGATES

(Maytansinoid conjugates with non-cleavable linkers)

 

Atty. Ref. No.

 

Country

 

Appl. No.

 

Filing Date

 

Priority Date

 

Patent No.

 

Issue Date

 

Expiry Date

P8662

 

U.S.

 

60/509,901

 

10-Oct-03

 

 

 

Provisional

 

 

 

 

A8662

 

U.S.

 

10/960,602

 

08-Oct-04

 

10-Oct-03

 

Pending

 

 

 

 

F189422

 

PCT

 

PCT/US04/030917

 

12-Oct-04

 

10-Oct-03

 

Pending

 

 

 

 

 

A-3

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

 

PEG LINKER

 

(Cytotoxic agents bearing a reactive polyethylene glycol moiety, cytotoxic
conjugates comprising polyethylene glycol linking groups,

and methods of making and using the same)

 

Atty. Ref. No.

 

Country

 

Appl. No.

 

Filing Date

 

Priority Date

 

Patent No.

 

Issue Date

 

Expiry Date

A8212

 

U.S.

 

10/024,290

 

21-Dec-01

 

 

 

6,716,821

 

6-Apr-04

 

21-Dec-21

F159322

 

PCT

 

PCT/US02/25972

 

10-Sep-02

 

21-Dec-01

 

Pub. No. WO 03/068144 A2 (8/21/03)

 

 

 

 

F159301

 

Australia

 

2002332542

 

10-Sep-02

 

21-Dec-01

 

Pending

 

 

 

 

F159302

 

Canada

 

2,462,085

 

10-Sep-02

 

21-Dec-01

 

Pending

 

 

 

 

F159303

 

Europe

 

02806788.2

 

10-Sep-02

 

21-Dec-01

 

Pending

 

 

 

 

F159304

 

Japan

 

2003-567329

 

10-Sep-02

 

21-Dec-01

 

Pending

 

 

 

 

F159321

 

New Zealand

 

529834

 

10-Sep-02

 

21-Dec-01

 

Pending

 

 

 

 

 

NITRO-PYRIDYL LINKER

 

(Cross-linkers with high reactivity and solubility and their use in the
preparation of conjugates for targeted delivery of small molecule

drugs)

 

Atty. Ref. No.

 

Country

 

Appl. No.

 

Filing Date

 

Priority Date

 

Patent No.

 

Issue Date

 

Expiry Date

P8359

 

U.S.

 

60/403,652

 

16-Aug-02

 

 

 

Provisional

 

 

 

 

A8359

 

U.S.

 

10/633,616

 

05-Aug-03

 

16-Aug-02

 

Allowed (9/16/04)

 

 

 

 

F171622

 

PCT

 

PCT/US03/22494

 

05-Aug-03

 

16-Aug-02

 

Pub. No. WO 04/016801 A2 (2/26/04)

 

 

 

 

 

SYNERGY

(Compositions and methods for treating cancer using immunoconjugates and
chemotherapeutic agents)

 

Atty. Ref. No.

 

Country

 

Appl. No.

 

Filing Date

 

Priority Date

 

Patent No.

 

Issue Date

 

Expiry Date

104322.198

 

U.S.

 

09/671,995

 

29-Sep-00

 

10/01/99

 

Pending

 

 

 

 

104322.198WO

 

PCT

 

PCT/US00/26800

 

29-Sep-00

 

01-Oct-99

 

Pub. No. WO 01/24763 (04/12/01)

 

 

 

 

104322.198EP

 

Europe

 

970516.1

 

29-Sep-00

 

01-Oct-99

 

Pub. No. 1229934 (08/14/02)

 

 

 

 

104322.198JP

 

Japan

 

2001-527762

 

04/01/02?

 

01-Oct-99

 

Pub. No. 2003-528034 (09/24/03)

 

 

 

 

104322.198CA

 

Canada

 

2,385,528

 

29-Sep-00

 

01-Oct-99

 

Pending

 

 

 

 

104322.198AU

 

Australia

 

79885/00

 

29-Sep-00

 

01-Oct-99

 

Allowed (6/17/04)

 

 

 

 

104322.198HK

 

Hong Kong

 

3100743.7

 

29-Jan-03

 

01-Oct-99

 

Pending

 

 

 

 

 

A-4

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

 

SCHEDULE B

 

PROVISIONS FOR SUPPLY AGREEMENTS

 

All Supply Agreements will include:

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

B-1

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

 

SCHEDULE C

 

CENTOCOR BACKGROUND TECHNOLOGY

 

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

 

C-1

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

 

SCHEDULE D

 

ADVERSE EVENT REPORTING PROCEDURES FOR LICENSED PRODUCT

 

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

 

A.                                   DEFINITIONS

 

Capitalized terms in this Appendix have the following meanings.  Capitalized
terms not defined in this Appendix shall have the meanings assigned to them in
the Agreement.

 

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

 

(a) [***************************************];

 

(b) [***************************************];

 

(c) [******]; and

 

(d) [************].

 

The term [*************] also includes a [*******] of
[*************************] of the [*******].

 

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

 

(a) [*********************];

 

(b) [***************************************];

 

(c) [***************];

 

(d) [***************************************]; or

 

(e) [***************************************].

 

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

 

D-1

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

 

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

 

5.             [******************************************************************************************
**********************************************************************************************************
*********************].

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

2.                                      
[**************************************************************************:

 

(a)             [**********************************************************************************
**********************************************************************************************************
**********************************************************************].

 

(b)             [**********************************************************************************
**********************************************************************************************************
*****].

 

D-2

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

 

D.                                    [******************************]

 

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

 

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

 

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

 

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

 

5.             [******************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
******************************************].

 

6.             [******************************************************************************************
**********************************************************************************************************
********************************************************************].

 

7.             [******************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************].

 

8.             [******************************************************************************************
***********].

 

9.             [******************************************************************************************
**********************************************************************************************************
**************************************].

 

D-3

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

 

SCHEDULE E

 

DISPUTE RESOLUTION PROCEDURES

 

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

 

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

 

b.         [********************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
****************************************************************************************].

 

c.         [********************************************************************************************
**********************************************************************************************************
*********************************************************************************].

 

d.         [********************************************************************************************
**********************************************************************************************************
***************].

 

e.         [********************************************************************************************
***********************************************

 

E-1

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

 

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

 

f.         [********************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
*****************************].

 

g.         [********************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
*****************].

 

h.         [********************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
***************************************].

 

i.         [*********************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
*********

 

E-2

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

 

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

 

j.         [********************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
****************************************************************************************************].

 

k.         [********************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
******************************************************************************].

 

E-3

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

 

l.         [*********************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
*****************************************************************************].

 

m.         [********************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
****************].

 

n.         *********************************************************************************************
**********************************************************************************************************
**********************************************************************************************************
***************].

 

E-4

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

 

o.         [*********************************************************************************************
**********************************************************************************************************
*******************************************************************************************************].

 

p.         [********************************************************].

 

q.         [********************************************************************************************
***************].

 

r.         [********************************************************************************************
*************].

 

s.         [********************************************************************************************
*******************************].

 

E-5

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

 

SCHEDULE F

 

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

 

[********************************************************************
******************************************************************:

 

(a)          [******************************************************]
[******************************************************]
[******************************************************]
[********************************************]

 

(b)         [******************************************************]
[******************************************************]
[*******]

 

(c)          [******************************************************]
[******************************************************]
[******************************************************]
[*********************************].

 

F-1

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