Document:

PLAN DOCUMENT

 

 

Executive

Stock Option Based Incentive Program

Fiscal Year 2003

(“Incentive Program”)

 

 

 

 

Contents

 

 

A.                 Purpose

 

B.                   Management Participation

Qualifications

 

C.                   Incentive Program Changes

 

D.                  Rules

 

E.                    Overall

Incentive Program Concepts and Definitions

 

F.                    Example

 

G.                   Procedure

 

 

 

Attachment:   Letter Acknowledging Participation

 

 

 

A.            Purpose

 

The purpose of the Executive Stock Option Based

Incentive Program for Fiscal Year 2003 (“Incentive Program”) is to encourage

and reward performance which contributes to the Company’s growth and

success.  Stock option incentives which

complement base salary will be awarded to eligible Exar executives.

 

 

B.            Management

Participant Qualifications

 

1.               Direct participation is limited to those executives

who have a primary responsibility  for

the operation, profits, and direction of Exar.

 

2.               Participation shall be recommended by the

President/CEO and is subject to approval by the Compensation and Employee

Option Administration Committees of the Board of Directors.

 

3.               Participation and the Incentive Program information

divulged is considered confidential and may not be discussed to others.

 

 

C.            Incentive

Program Changes

 

As business conditions, participants’ positions, or

the Company’s needs change, the Compensation and Employee Option Administration

Committees reserve the right to modify or cancel at any time this Incentive

Program, with prior notice, and participants should not presume continued

participation in an Incentive Program.

 

 

D.            Rules

 

1.               This Incentive Program is especially designed for FY

2003.  Participants in previous year(s)

are not automatically included in subsequent years.  A number of factors may change from year to year, such as:

business conditions, individual employee contribution, criticality of certain

positions, etc.

 

2.               The President/CEO will make incentive stock option

recommendations for all participants, other than himself, to be submitted to

the Compensation and Employee Option Administration Committees for final

approval.

 

3.               The Compensation and Employee Option Administration

Committees will have final authority and determination for the number of incentive

stock options awarded under the terms of this Incentive Program, including to

the President/CEO.

 

 

2

 

4.               Inclusion in the Incentive Program does not constitute

a guarantee of employment, or specific award of future stock options.

 

 

E.              

Overall Incentive Program Concepts and Definitions

 

1.               Base

Salary:  Projected base salary as of March 31, 2002.

2.               Target

Cash Incentive:

A percentage of the projected base salary used to calculate the stock option

award, as determined by the Compensation Committee.

3.               Stock

Option Award:  The basis for the number of options awarded

will be calculated using the employee’s Target Cash Incentive, divided by an

estimated gain per share of $10.   The

final number of stock options awarded may be adjusted at the discretion of the

President/CEO and with the approval of the Compensation and Employee Option

Administration Committees of the Board of Directors. Options granted are

“non-qualified” and therefore subject to applicable taxes at the time of

exercise.

4.               Stock

Option Price:  $22.925 per share (fair market value of Exar

stock as of December 5, 2001).

5.               Option

Grant Date:  December 5, 2001.

6.               Vesting

Schedule:  Stock options granted for this Incentive

Program will vest in equal amounts over a twelve month period beginning April

5, 2002 and ending March 5, 2003.

7.               Expiration

of Grant:  Seven (7) years from the date of grant, or

three (3) months from the participant’s date of termination, whichever is

sooner.

 

F.               Example

 

	

  Employee

  projected base salary on 3/31/02

  	

   

  	

  $

  	

  200,000

  	

   

  
	

  Target Cash

  Incentive @ 35%

  	

   

  	

  $

  	

  70,000

  	

   

  
	

  Estimated gain

  per share

  	

   

  	

  $

  	

  10

  	

   

  

 

Stock Option Award:

 

	

   

  	

  $70,000

  	

  =

  	

  7,000 options 

  (may be modified by Board of Directors)

  	

   

  
	

   

  	

  $10

  	

   

  	

   

  	

   

  

 

 

3

 

G.            Procedure

 

Employees selected for inclusion in the Incentive

Program will be notified in writing and provided a copy of the Incentive

Program.  Any changes in the Incentive

Program or the measurement criteria must be approved in writing by the

Compensation and Employee Option Administration Committees.

 

Participants are eligible to exercise their options at

any time once they are vested, subject to insider trader rules.

 

 

4

Attachment

 

 

 

 

 

I

acknowledge receiving a copy of the “Executive Stock Option Based Incentive

Program.”  I have read and understand

the terms of this Incentive Program, and also understand that this Incentive

Program neither constitutes a contract of employment nor a representation as to

my future earnings or award of stock options. 

The Letter of Notification and the Incentive Program constitute the

entire agreement and supersede any prior written and oral agreements with

respect to the Stock Option Awards under the Incentive Program.  Further, I understand that the Compensation

and Employee Option Administration Committees of the Board of Directors have

the sole discretionary authority for interpreting the provisions of the

Incentive Program and approving eligibility.

 

 

 

 

	

   

  	

   

  
	

   

  	

   

  
	

   

  	

  Employee Name (Please

  Print)

  
	

   

  	

   

  
	

   

  	

   

  
	

   

  	

  Employee Signature

  
	

   

  	

   

  
	

   

  	

   

  
	

   

  	

  Date

  

 

 

 

5Development and License Agreement

Development and License Agreement

between

 

ImmunoGen, Inc.

128 Sidney Street

Cambridge, MA  02139

U.S.A.

(hereinafter called “ImmunoGen”)

 

and

 

Boehringer Ingelheim

International GmbH

Binger Strasse 173

55218 Ingelheim am Rhein

GERMANY

(hereinafter called “BI”)

 

having an Effective Date of

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

 

WITNESSETH:

 

WHEREAS, BI is a pharmaceutical company engaged in the

research, development, manufacture and commercialisation of pharmaceutical

products and Controls certain patents and know-how related to the humanised

monoclonal antibody BIWA4; and

 

WHEREAS, ImmunoGen Controls certain patents, and

know-how related to ImmunoGen’s maytansinoid DM1 technology, and it has the

right to grant certain rights and licenses thereunder as set forth herein; and

 

WHEREAS, BI desires to obtain a license from ImmunoGen

to develop, manufacture, market and sell the Licensed Products in the

Territory, and ImmunoGen desires to grant such a license to BI, on the terms

and conditions contained in this Agreement.

 

NOW THEREFORE, in consideration of the covenants and promises

in this Agreement, ImmunoGen and BI agree as follows:

 

1

 

Table of Contents

 

	

  1.

  	

  DEFINITIONS

  
	

  2.

  	

  GRANT OF RIGHTS AND

  RESTRICTIONS

  
	

  3.

  	

  PAYMENTS, REPORTS AND

  RECORDS

  
	

  4.

  	

  DEVELOPMENT AND

  COMMERCIALISATION

  
	

  5.

  	

  SUPPLY AND

  MANUFACTURING OBLIGATIONS

  
	

  6.

  	

  PRODUCT

  INQUIRIES, COMPLAINTS AND ADVERSE EVENTS

  
	

  7.

  	

  RIGHTS

  AND IMPROVEMENTS

  
	

  8.

  	

  PATENTS

  AND TRADEMARKS

  
	

  9.

  	

  INFRINGEMENT

  
	

  10.

  	

  REPRESENTATIONS AND

  WARRANTIES

  
	

  11.

  	

  INDEMNIFICATION

  
	

  12.

  	

  CONFIDENTIALITY

  
	

  13.

  	

  TERM

  AND TERMINATION

  
	

  14.

  	

  EFFECTS

  OF TERMINATION

  
	

  15.

  	

  MISCELLANEOUS

  
	

  16.

  	

  SCHEDULES

  

 

2

 

	

  1.

  	

  DEFINITIONS

  	

   

  
	

   

  	

   

  	

   

  
	

  1.1

  	

  “Adverse Event”

  	

  shall mean any untoward

  medical occurrence in a patient or subject who is administered a Licensed

  Product, whether or not considered related to the Licensed Product, including,

  without limitation, any undesirable sign (including abnormal laboratory

  findings of clinical concern), symptom or disease temporally associated with

  the use of such Licensed Product.

  
	

   

  	

   

  	

   

  
	

  1.2

  	

  “Affiliates”

  	

  shall mean any company or

  business entity which controls, is controlled by, or is under common control

  with, either ImmunoGen or BI.  For

  purposes of this definition, “control” shall mean the possession, directly or

  indirectly or the power to direct or cause the direction of the management

  and policies of an entity (other than a natural person), whether through the

  majority ownership of voting capital stock, by contract or otherwise.

  
	

   

  	

   

  	

   

  
	

  1.3

  	

  “BI Materials”

  	

  shall mean any tangible

  chemical, biological or research materials, including without limitation, any

  assays or antibodies, whether or not patentable, used by BI or furnished by

  BI to ImmunoGen under this Agreement. 

  BI Materials shall include, without limitation, the BIWA4 antibody.

   

  
	

  1.4

  	

  “BI Intellectual Property”

  	

  shall mean any Technology

  and Patent Rights Controlled by BI during the Term that are used by BI or

  provided by BI for use in the activities contemplated by this Agreement.  BI Intellectual Property Patent Rights as

  of the Effective Date are described on Schedule C.

  
	

   

  	

   

  	

   

  
	

  1.5

  	

  “BIWI1”

  	

  shall mean any conjugate of

  “naked” BIWA4 with DM1.

  
	

   

  	

   

  	

   

  
	

  1.6 

  	

  “Commercially Reasonable

  Efforts”

  	

  shall mean the efforts and

  resources that BI would use for a compound owned by it or to which is has

  rights, which is of similar market potential at a similar stage in

  development as the applicable Licensed Product, taking into account the

  competitiveness of the marketplace, the proprietary position of the Licensed

  Product, the profitability and the relative potential safety and efficacy of

  the Licensed Product, and other relevant factors including, without,

  limitation, technical, legal, scientific or medical factors.

  
	

   

  	

   

  	

   

  
	

  1.7

  	

  “Comparable Product”

  	

  shall mean any [ * ] that has the

  same [ * ]

  as a Licensed Product.

  
	

   

  	

   

  	

   

  
	

  1.8

  	

  “Competent Authorities”

  	

  shall mean the United States

  Food and Drug Administration (FDA), the European Commission and any foreign

  health authority charged with responsibility for regulating the approval to

  market a Licensed Product for the treatment of humans.

  

 

3

 

	

  1.9

  	

  “Control”

  	

  shall mean, with respect to

  tangible or intangible property, including intellectual property or other

  matters, title to such property and/or possession of the ability to grant a

  license or sublicense to such property without violating any agreement with a

  third party.

  
	

   

  	

   

  	

   

  
	

  1.10

  	

  “[ * ] ”

  	

  shall mean with respect to any Drug Substance or

  Drug Product, the  [ * ] of producing (including the  [ * ] of such Drug Substance and Drug Product, including the sum of the

  following components: (a) the  [ * ] , including[ * ]and [ * ], of [ * ] and [ * ] such BIWI1; (b) all [ * ] incurred by ImmunoGen attributable to

  the [ * ] under the foregoing

  clause (a), including, without limitation, [ * ] and [ * ]

  which are [ * ] to [ * ] or another [ * ]; (c) any other [ * ] borne by ImmunoGen for the [ * ] and/or [ * ] of

  such Drug Substance and Drug Product; and (d) [ * ] and [ * ]

  which are [ * ] to [ * ] or another [ * ] . 

  Notwithstanding the foregoing, [ * ] of Drug Substance shall not include the [ * ] of [ * ] any [ * ] to the [ * ] by BI pursuant to Section [ * ] 

  of this Agreement.

  
	

   

  	

   

  	

   

  
	

  1.11

  	

  “DM1”

  	

  shall mean that certain

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

  
	

   

  	

   

  	

   

  
	

  1.12

  	

  “Drug Product”

  	

  shall mean Drug Substance,

  manufactured under cGMP in the final concentration for clinical use,

  aseptically filled in unlabeled, primary packaging material.

  
	

   

  	

   

  	

   

  
	

  1.13

  	

  “Drug Substance”

  	

  shall mean bulk BIWI1.

  
	

   

  	

   

  	

   

  
	

  1.14

  	

  “Effective Date”

  	

  shall mean the date first

  mentioned above.

  
	

   

  	

   

  	

   

  
	

  1.15

  	

  “Field”

  	

  shall mean [ * ].

  
	

   

  	

   

  	

   

  
	

  1.16

  	

  “First Commercial Sale”

  	

  shall mean the date of the

  first commercial sale (other than for purposes of obtaining regulatory

  approval) of a Licensed Product by or on behalf of BI or any Sublicensee of

  BI.

  
	

   

  	

   

  	

   

  
	

  1.17

  	

  “ImmunoGen Materials”

  	

  shall mean any tangible

  chemical, biological or research materials, including without limitation,

  DM1, or any assays or antibodies other than BI Materials, whether or not

  patentable, used by ImmunoGen or furnished by ImmunoGen to BI under this

  Agreement.

  

 

4

 

	

  1.18

  	

  “Improvement(s)”

  	

  shall mean any enhancement,

  improvement or modification to the Licensed Technology or covered by the

  Licensed Patent Rights which is conceived, reduced to practice or discovered

  during the Term of this Agreement.

  
	

   

  	

   

  	

   

  
	

  1.19

  	

  “Indication”

  	

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

  
	

   

  	

   

  	

   

  
	

  1.20

  	

  “Initiation”

  	

  shall mean, with respect to

  any clinical study, the [ * ] for such clinical study by or on behalf of BI.

  
	

   

  	

   

  	

   

  
	

  1.21

  	

  “IND”

  	

  shall mean an

  investigational new drug application (as defined in Title 21 of the United

  States Code of Federal Regulations, as amended from time to time) filed or to

  be filed with the FDA with regard to any Licensed Product.

  
	

   

  	

   

  	

   

  
	

  1.22

  	

  “Licensed Product(s)”

  	

  shall mean any product

  containing a conjugate of DM1 with an antibody or antibody derivative that is

  specific for the Target Antigen, including, without limitation, BIWI1, and

  any drug product containing such conjugate. 

  For purposes of clarity, the Parties hereby acknowledge and agree that

  a given Licensed Product that has one or more Indications shall not be

  considered to be a Subsequent Licensed Product for purposes of Section 3.3(d)

  of this Agreement.

  
	

   

  	

   

  	

   

  
	

  1.23

  	

  “Licensed Technology”

  	

  shall mean (i) the

  Technology described on Schedule A attached hereto; and (ii) any

  Improvements thereto (other than Improvements that are Patent Rights)

  Controlled by ImmunoGen during the Term of the Agreement [ * ] to the extent [ * ] in accordance

  with Section 2.3 hereof, [ * ] to the extent that any of the foregoing relates to any

  Licensed Patent Rights or is necessary or useful to develop, have developed,

  make, have made, sell and have sold Licensed Products.

  
	

   

  	

   

  	

   

  
	

  1.24

  	

  “Licensed Patent Rights”

  	

  shall mean the Patent Rights

  in the Field in the Territory Controlled by ImmunoGen during the Term which

  block, absent a license, the use, making or selling of a Licensed Product.

  Licensed Patent Rights as of the Effective Date are described on Schedule [ * ]  attached thereto.

  
	

   

  	

   

  	

   

  
	

  1.25

  	

  “Major Markets”

  	

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

  
	

   

  	

   

  	

   

  

 

5

 

	

  1.26

  	

  “Net Sales”

  	

  shall mean, as to each [ * ] during the [ * ], the [ * ] for all [ * ] sold by BI and

  its Sublicensees to third parties throughout the [ * ] 

  during such [ * ], less the [ * ] or [ * ] by BI or its Sublicensees during such [ * ] with respect

  to [ * ] of

  [ * ]

  regardless of the [ *

  ] in which such [ * ] were made:

  
	

   

  	

   

  	

   

  
	

   

  	

   

  	

  (a)

  	

  [ * ]and [ * ]

  or [ * ]

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

  
	

   

  	

   

  	

   

  	

   

  
	

   

  	

   

  	

  (b)

  	

  [ * ]]or [ * ]

  given or made for [ *

  ] or [ * ]

  of [ * ] or

  for [ * ]

  (including [ * ]

  and similar types of [

  * ]);

  
	

   

  	

   

  	

   

  	

   

  
	

   

  	

   

  	

  (c)

  	

  any [ * ] for [ * ]and other [ * ] directly

  related to the [ * ]

  of [ * ] to

  the extent included in the[ * ];

  
	

   

  	

   

  	

   

  	

   

  
	

   

  	

   

  	

  (d)

  	

  any [ * ] or [ * ] levied on the [ * ] or [ * ] of a [ * ]] (including

  any [ * ]

  such as a [ * ]

  or [ * ] or

  [ * ])

  borne by the seller thereof, other than [ * ]or of any kind whatsoever; and

  
	

   

  	

   

  	

   

  	

   

  
	

   

  	

   

  	

  (e)

  	

  any [ * ] or [ * ] or their

  equivalent borne by the seller.

  
	

   

  	

   

  	

   

  
	

  1.27

  	

  “Patent Rights”

  	

  shall mean the rights and

  interests in and to any and all issued patents and pending patent

  applications (including inventor’s certificates and utility models) in any

  country or jurisdiction in the Territory, including any and all provisions,

  non-provisionals, substitutions, continuations, continuations-in-part,

  divisionals and other continuing applications, supplementary protection

  certificates, renewals, and all letters patent on any of the foregoing, and

  any and all reissues, reexaminations, extensions, confirmations,

  registrations and patents of addition of any of the foregoing.

  
	

   

  	

   

  	

   

  
	

  1.28

  	

  “Phase I Trial”

  	

  shall mean any clinical

  study involving the use of the Licensed Product in humans that is designed

  primarily to obtain preliminary safety data on the use of a Licensed Product

  in human patients.

  
	

   

  	

   

  	

   

  
	

  1.29

  	

  “Phase IIa Trial”

  	

  shall mean any controlled

  clinical study involving the use of the Licensed Product in human patients

  that is designed primarily to obtain preliminary data on the effectiveness of

  a specific therapy involving the use of a Licensed Product in human

  patients.  Phase IIa Trials must take

  place after Phase I Trials.

  
	

   

  	

   

  	

   

  
	

  1.30

  	

  “Pivotal Trial”

  	

  shall mean any Phase IIb/III

  clinical study involving a Licensed Product and having adequate statistical

  power to meet the requirements for regulatory approval by the FDA or the

  European Commission.

  
	

   

  	

   

  	

   

  
	

  1.31

  	

  “Recognised Agents”

  	

  shall mean any third party

  legal entity (other than an Affiliate of BI) engaged by BI in the normal

  course of its business to market and/or distribute its products in a

  particular country of the Territory.

  

 

6

 

	

  1.32

  	

  “Sublicensee”

  	

  shall mean any person,

  corporation, unincorporated body, or other entity including Affiliates of BI

  to whom BI grants a sublicense of the rights granted to BI pursuant to this

  Agreement. For the avoidance of doubt, Recognised Agents shall not be

  considered to be Sublicensees for the purposes of this Agreement.

  
	

   

  	

   

  	

   

  
	

  1.33

  	

  “Target Antigen”

  	

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

  Section [ * ]  applies, [ * ]

  
	

   

  	

   

  	

   

  
	

  1.34

  	

  “Technology”

  	

  shall mean and include any

  and all unpatented proprietary ideas, inventions, discoveries, data, results,

  formulae, designs, specifications, methods, processes, formulations,

  techniques, ideas, know-how, technical information (including, without

  limitation, structural and functional information), process information, and

  any and all proprietary biological, chemical, pharmacological, toxicological,

  pharmacokinetic, chemical, analytical, pharmaceutical, and clinical data.

  
	

   

  	

   

  	

   

  
	

  1.35

  	

  “Territory”

  	

  shall mean the world.

  
	

   

  	

   

  	

   

  
	

  1.36

  	

  “Valid Claim”

  	

  shall mean a claim in an

  issued, unexpired patent within the Licensed Patent Rights that (i) has not

  been finally cancelled, withdrawn, abandoned or rejected by any

  administrative agency or other body of competent jurisdiction and (ii) has

  not been revoked, held invalid, or declared unpatentable or unenforceable in

  a decision of a court or other body of competent jurisdiction that is

  unappealable or unappealed within the time allowed for appeal.

  

 

2.             GRANT

OF RIGHTS AND RESTRICTIONS

 

2.1           Grant of License to BI:

 

Subject to

the terms and conditions of this Agreement, ImmunoGen grants to BI, and BI

accepts, an exclusive, royalty-bearing license, including the right to grant

sublicenses as described below, within the Field and in the Territory, under

the Licensed Technology and the Licensed Patent Rights and ImmunoGen’s interest

in any Improvements Controlled by ImmunoGen to the extent accepted in

accordance with Section 2.3 hereof, to develop, make, use and sell Licensed

Products.

 

2.2           ImmunoGen Retained Rights:

 

Subject to the

other terms of this Agreement, ImmunoGen retains the right to use the Licensed

Technology and practice the Licensed Patent Rights and to use ImmunoGen’s

interest in all Improvements (i) to perform its work under this Agreement (ii)

to develop, have developed, make, have made, use, have used, sell have sold,

offer for sale, import, have imported, export and have exported any product

that is not a Licensed Product and (iii) for any and all uses outside of the

Field.

 

7

 

2.3           Additional Rights:

 

(a)                                  ImmunoGen herewith grants to BI [ * ] during the Term

regarding all Improvements (including its interest in any Improvements owned

jointly by ImmunoGen and BI) Controlled by ImmunoGen or its Affiliates during

the Term to the extent such Improvements relate to any Licensed Patent Rights

or are necessary or useful to develop, have developed, make, have made, sell

and have sold Licensed Products. If BI [ * ] ImmunoGen [ * ] of its [ * ] in the respective Improvement at any

time during the Term, BI shall [ * ] an [ * ] so long as such Improvement is Controlled by ImmunoGen

at the [ * ]

of such[ * ],

consistent with the terms of[ * ], which [ * ]such Improvement to the [ * ] of the Licensed Patent Rights and/or

Licensed Technology, as the case may be, [ * ] any [ * ] from BI to ImmunoGen.

 

(b)                                 BI hereby grants to ImmunoGen a non-exclusive,

royalty-free license under BI Intellectual Property and BI’s interest in any

Improvements to manufacture the Drug Substance and Drug Product solely for

delivery to BI, its Affiliates, Recognised Agents and Sublicensees for the

limited duration and purposes as set forth in Section 5 below and subject to

the terms of this Agreement and the Clinical Supply Agreement attached as Schedule

G.

 

2.4           Right to

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

 

(a)                                  BI shall have the right to grant sublicenses of its rights granted

under Section 2.1 hereof to its Affiliates and other Sublicensees.

 

(b)                                 BI agrees to contractually bind its

Sublicensees by terms and obligations substantially similar to those applying

to BI hereunder, including without limitation, BI's confidentiality and royalty

obligations.

 

(c)                                  BI shall have the right to partner with third

parties to co-market and/or co-promote the Licensed Products in all countries

of the Territory.

 

(d)                                 Notwithstanding anything herein to the

contrary, BI shall be responsible for all obligations herein to be performed by

it and any Sublicensee or partner.  BI

shall also be responsible for any and all breaches of any obligations hereunder

by any Sublicensee, Recognised Agent, partner and other subcontractor of BI.

 

(e)                                  BI shall not license its interest in any Improvements to any third

party, other than in connection with the grant of a sublicense to a Licensed

Product or any license or sublicense to any other product containing DM1

Controlled by BI.  Subject to the

foregoing, BI shall be free to use its interest in any Improvements for all

purposes, including, without limitation, the sale of DM1 and DM1 intermediates

to third parties.

 

8

 

3.             PAYMENTS,

REPORTS AND RECORDS

 

3.1           Upfront-fee:

 

In consideration of the rights granted by

ImmunoGen to BI hereunder, BI will pay ImmunoGen the non-refundable,

non-creditable sum of [ * ]

to an account designated by ImmunoGen within [ * ] business days following the Effective Date.

 

3.2           Milestone

Payments:

 

(a)                                  In further consideration of the rights granted by ImmunoGen to BI

hereunder, including the licenses set forth in Section 2 above, BI will pay

ImmunoGen non-refundable, non-creditable milestone payments as follows:

 

(i)            [ * ]:                                                   Payment

	

    Upon [ *

  ]of an [ *

  ]in the [ *

  ]for a[ * ].

  	

  [ * ]

  

 

(ii)           [ *

]:                                                   Payment

	

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

  	

  [ * ]

  
	

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

  	

  [ * ]

  
	

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

  	

  [ * ]

  
	

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

  	

  [ * ]

  
	

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

  	

  [ * ]

  
	

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

  	

  [ * ]

  
	

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

  	

  [ * ]

  
	

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

  	

  [ * ]

  
	

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

  	

  [ * ]

  
	

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

  	

  [ * ]

  
	

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

  	

  [ * ]

  

 

(iii)          [ * ]:

 

A [ * ]of :

·      [ * ]

·      [ * ]

·      [ * ]

·      [ * ]

 

(b)                                 BI shall pay ImmunoGen the [ * ]

set forth in Section [ * ]  and [ * ]  within [ * ] of the occurrence of the respective [ * ] and the [ * ] pursuant to Section [ * ]  within [ * ] of the [ * ] of the[ * ]. The [ * ] pursuant to Section [ * ]  and the [ * ] pursuant to Section [ * ]  and [ * ]shall be [ * ] in[ * ]. The [ * ] pursuant to Section [ * ]  shall be [ * ] in[ * ].

 

9

 

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

for any [ * ]

of [ * ] by a[ * ].

 

3.3           Royalty Payments:

 

(a)                                  In further consideration of the rights granted by ImmunoGen to BI

hereunder, including the licenses set forth in Section 2 above, BI will pay

ImmunoGen a [ * ]on

[ * ]of [ * ]by a [ * ]under a [ * ] or [ * ] as follows:

 

[ * ]                                                        [

* ]                                                     [

* ]

[ * ]                                                        [

* ]                                                     [

* ]

[ * ]                                                        [

* ]                                                     [

* ]

[ * ]                                                        [

* ]                                                     [

* ]

[ * ]                                                               

 

**For purposes of

this Section 3.3(a), “[

* ]” shall refer to the [ * ]to [ * ]to [ * ]such that the “[ * ]” shall be [ * ]if ImmunoGen [ * ] a [ * ] with such[ * ].

 

(b)                                 The above [ * ]

shall be [ * ]

on a [ * ]

basis on the [ * ]

of [ * ] from

its [ * ]

until the [ * ]

of the [ * ]

as provided in Section [

* ]. The above [ * ] be [ * ] by [ * ] in [ * ] on a [ * ] basis with respect to[ * ] if (i) the[ * ] or [ * ]of such [ * ]in such country

is [ * ]by a [ * ]in [ * ]but is [ * ]by the[ * ]; or (ii) (A) the

[ * ]in [ * ]covering the [ * ]or of a [ * ], (B) [ * ]are [ * ]in such [ * ] and (C)

such [ * ]

have, in the [ * ]

during such[ * ]or

[ * ]of the [ * ] in such [ * ] in connection

with the [ * ]

of such[ * ]

 

(c)                                  In the event that BI, in order to [ * ]to it [ * ]hereunder in any[ * ], is required to [ * ] to [ * ] or [ * ] (i) to

[ * ] under

their [ * ]

in the [ * ]of

which the [ * ]

of a [ * ]

could not [ * ]

be [ * ] or [ * ] in such [ * ] and/or (ii) to [ * ] under their [ * ] specific to the [ * ] used by

ImmunoGen to[ * ],

in the [ * ]

of which any of the [ *

] necessary to [ * ] as part of a [ * ] can not [ * ] be [ * ] ([ * ], to the[ * ], by an [ * ]of[ * ]), then [ * ]due to [ * ]for a given [ * ]may be [ * ]by [ * ]of the [ * ]of such [ * ]Notwithstanding the following, such [ * ] shall in no

event [ * ]

the [ * ] for

such [ * ]payable

under [ * ]

Section [ * ]  to less than [ * ] of [ * ] in such[ * ]

 

10

 

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

 

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

 

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

 

(A) if BI at the [ * ] of the [ * ] is [ * ] in [ * ] with [ * ] of the [ * ]under Section [ * ]  of this Agreement, then until

the [ * ] of (i) the [ * ] of the [ * ] of the [ * ] covering the [ * ] or (ii) [ * ] from the [ * ] of [ * ] of such[ * ]; provided, that, [ * ]Section [ * ] 

of this Agreement, the [ * ] for any [ * ] covered by this Section 3.3(d)(2)(A)(ii) shall be [ * ] and;

 

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

 

3.4           Reports:

 

Each

royalty payment shall be accompanied by a written report describing the Net

Sales of the Licensed Product sold by or on behalf of BI, its Affiliates and

Sublicensees during a "Payment Period" in each country in the

Territory in which such Licensed Product occurred in the [ * ] covered by such

statement, specifying: the [ * ]  and [ * ] in each

country’s currency; the applicable [ * ] under this Agreement; the [ * ] in each

country’s currency, including an [ * ] of [ * ] taken in the [ * ] of[ * ]; the [ * ] to [ * ] from each [ * ] to[ * ], under this Section 3.4; and the [ * ] in[ * ].  Payment Period means a[ * ], commencing upon

the[ * ]

 

3.5           Method and Manner of Royalty

Payment:

 

(a)                                  BI shall deliver to ImmunoGen within [ * ] following the end of each [ * ] a [ * ] as set forth in

Section [ * ]  along with BI's payment to ImmunoGen of any [ * ] and [ * ] to ImmunoGen for

such[ * ].

 

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

 

3.6           Withholding

Tax:

 

(a)                                  BI shall [ * ] any [ * ] and other [ * ] from the [ * ] agreed upon

under Sections[ * ], and [ * ]  of this Agreement

and [ * ] them to the [ * ] required by law applicable at the date of [ * ] BI

shall maintain [ * ] of [ * ] of any [ * ] and forward these [ * ] to

ImmunoGen.

 

11

 

(b)                                 The parties will exercise their best efforts to ensure that any [ * ]

imposed are [ * ] as far as possible under the provisions of the current or any

future [ * ]between the [ * ] and the [ * ].

 

(c)                                  The parties hereby acknowledge that according to [ * ] this [ * ]

requires that the [ * ] a [ * ] of[ * ]

 

(d)                                 The parties hereby acknowledge that in order to achieve such [ * ]

ImmunoGen is required to provide [ * ] with the [ * ] for a [ * ] of [ * ]in

respect of [ * ] performed on the [ * ] containing the statement of [ * ] and [

* ] of the [ * ] as well as the [ * ] of [ * ] a [ * ] , in which it confirms

that it does not [ * ] the [ * ] through a [ * ] in [ * ] BI agrees to provide

ImmunoGen with the [ * ]

 

(e)                                  ImmunoGen hereby acknowledges that every [ * ] ImmunoGen is required to

submit a[ * ], which complies with the above-mentioned prerequisites.

 

3.8           Records:

 

BI and/or its Sublicensees shall keep and

maintain records of sales of Licensed Product so that the royalties payable and

the royalty statements may be verified. Such records shall be open to

inspection during business hours for a [ * ] period after the royalty period to which

such records relate, but in any event[ * ], by a nationally recognised independent

certified public accountant selected by ImmunoGen to whom BI has no reasonable

objections and retained at ImmunoGen's expense. Said accountant shall sign a

confidentiality agreement prepared by ImmunoGen and reasonably acceptable to BI

and shall then have the right to examine the records kept pursuant to this

Agreement and report to ImmunoGen the findings 

[ * ]

of said examination of records as are necessary to evidence that the records

were or were not maintained and used in accordance with this Agreement. A copy

of any report provided to ImmunoGen by the accountant shall be given

concurrently to BI. If said examination of records reveals any [ * ]of the[ * ], then BI shall

promptly pay the balance due to ImmunoGen, and if the [ * ] is/are more than[ * ], then BI shall

also bear the expenses of said accountant. If said examination of records

reveals any overpayment(s) of royalty payable, then ImmunoGen shall credit the

amount overpaid against BI's future royalty payment(s).

 

3.9           Overdue Payments.

 

Payments not paid

within the time period set forth in this Section 3 shall bear interest at a

rate of [

* ]per [ * ] from the due date until paid in

full.

 

4.             DEVELOPMENT

AND COMMERCIALISATION

 

4.1           Development

Responsibility:

 

(a)                                  Except as otherwise set forth in this Agreement, BI shall solely be

responsible for the development of the Licensed Product for the Field as

provided hereunder, including but not limited to any and all pre-clinical

development activities, clinical studies and other testing and work conducted

in connection with the Licensed Product for the Field, at BI's own expense and

BI shall be solely responsible for making decisions related hereto.

 

12

 

(b)                                 If prior to any [

* ] by BI with respect to a given[ * ], BI determines, in its reasonable

discretion, that the [ *

] of such [ *

] using the [

* ] has[ * ],

then BI shall have the right, upon not less than [ * ] prior written notice to ImmunoGen, to[ * ] as the [ * ] without any [ * ] from BI to

ImmunoGen.  Any decision regarding the [ * ] of [ * ] of a [ * ]that is [ * ] to the [ * ] is in the [ * ] of[ * ]

 

4.2           Development

Obligation:

 

(a)                                  After the Effective Date, BI shall use its [ * ] and shall accept the corresponding

responsibility, at its sole cost and expense, for the development, safety of,

and all required periodic reporting to Competent Authorities required to obtain

all regulatory approvals for, the Licensed Product(s) for the Field in the

Major Market countries.

 

(b)                                 After the Effective Date, BI shall provide to ImmunoGen regular written

reports every[ * ],

setting forth (i) significant developments with respect to Licensed Product,

and (ii) the status and progress of the development and/or registration

activities related to the Licensed Product.

 

(c)                                  BI shall promptly advise ImmunoGen in writing upon the filing for

regulatory approval to market a Licensed Product, and upon receipt of

regulatory approval to market a Licensed Product, in each case in each country

of the Territory.

 

(d)                                 ImmunoGen [ * ]

to [ * ] and [ * ] the [ * ] for [ * ] to meet [ * ]for [ * ] of [ * ] , according to

the [ * ]

attached as Schedule [ * ] and thereby agrees to maintain the [ * ] included in Schedule

[ * ]which

may be amended by the Parties during the development.  During this [ * ] and[ * ], ImmunoGen will keep BI informed on a regular basis and [ * ] be [ * ] to [ * ] and [ * ] to such[ * ], as appropriate.

 

(e)                                  ImmunoGen shall provide the necessary documentation and assist BI in

preparation of the chemical, pharmaceutical, and analytical sections of

regulatory submissions for IND or foreign equivalent.

 

4.3           Marketing

Efforts:

 

(a)                                  BI will use its Commercially Reasonable Efforts during the Term of this

Agreement to commercialise a Licensed Product in each Major Market in which

such Licensed Product is approved for marketing.  Notwithstanding BI’s [ * ]to[ * ] in[ * ], BI shall not discontinue such efforts for

any reason other than Force Majeure, mutual agreement of the parties and/or

material adverse side effects in rendering such Licensed Product unsuitable as

a medicine for human use.

 

(b)                               With respect to each country in the Territory that is not a Major

Market, BI shall have the right to determine, in its sole judgement, whether

and to what extent it will commercialise the Licensed Product in each such

country in which the Licensed Product is approved for marketing.

 

13

 

(c)                                  All commercialisation efforts undertaken by BI's Affiliates,

Sublicensees and Recognised Agents hereunder shall be attributable to BI.

 

4.4           Effect of Failure to Use[ * ]

 

In the event that

BI fails to use [ * ]as

described in Section[ * ], then ImmunoGen shall have the right to terminate the Agreement in

accordance with Section 13.2.

 

5.             SUPPLY AND MANUFACTURING OBLIGATIONS

 

5.1           Non-clinical Material; Clinical Material;

Dedicated Equipment

 

(a)                                  During the Term of this Agreement, ImmunoGen will[ * ] BI with its [ * ] of [ * ]in [ * ]and [ * ]as well as [ * ]and [ * ]for the [ * ]of [ * ]and [ * ]and [ * ]in [ * ]and in [ * ]in order for BI

to [ * ]of

the[ * ], as

listed on Schedule [ * ]attached

hereto.  BI will pay ImmunoGen a

transfer price for such [

* ]equal to [

* ]of ImmunoGen’s [ * ]of[

* ].  In addition, ImmunoGen

will [ * ]BI

with [ * ]at

least a [ * ]of

the [ * ]in

its [ * ].  A [ * ]will be [ * ]and [ * ]until the earlier of the [ * ] of [ * ] or until[ * ].  For GLP material, ImmunoGen will provide a

Certificate of Analysis for each batch manufactured.

 

(b)                                 In the event that, over a given[ * ],[ * ]to [ * ]with [ * ]of its [ * ]of [ * ]for that [ * ]in the [ * ]as specified in Schedule [ * ]and such [ * ]is not

attributable to a [ * ]set

forth in Section [ * ]  or BI’s [ * ] to [ * ] an [ * ] of [ * ] in a timely manner, then, subject to the [ * ] of [ * ] Section[ * ],[ * ]as follows.  If such [ * ] to [ * ] to[ * ], then [ * ]the [ * ]and [ * ]to Section[ * ]. 

If [ * ]to

[ * ]of[ * ], then [ * ] the [ * ] and [ * ] to Section[ * ].  The foregoing notwithstanding, [ * ] the [ * ] of the [ * ] to [ * ]such [ * ] and [ * ]

 

(c)                                  In addition, [ *

] with such [

* ] of [ * ]

in order for BI to [ * ]

until [ * ]of

[ * ] and[ * ]. The terms and

conditions of the supply of Drug Product shall be governed by the Clinical

Supply Agreement between ImmunoGen and Boehringer Ingelheim Pharma KG (“BI

Pharma”) attached hereto as Schedule G.

 

(d)                                 If ImmunoGen determines that it is necessary or advisable to purchase

dedicated equipment in order to manufacture non-clinical Drug Substance for BI,

BI will reimburse ImmunoGen for the cost of procuring such dedicated equipment[ * ].  In case of termination,

ImmunoGen shall permit BI to remove such dedicated equipment at BI’s sole cost

and expense.

 

(e)                                  The [ * ] in Section [ * ] and [ * ] of the

Clinical Supply Agreement shall also apply for non-clinical material.

 

14

 

5.2           Technology

Transfer.

 

As soon as

reasonably practicable following the Effective Date, ImmunoGen will transfer to

BI and its agents such Technology within its Control related to the Licensed

Technology and [ * ] as may be reasonably required by BI for the [ * ] of [ * ] in accordance with the [ * ] to be agreed upon by BI and

ImmunoGen before[ * ], the major terms of which are attached hereto as Schedule[ * ].

 

6.             PRODUCT

INQUIRIES, COMPLAINTS AND ADVERSE EVENTS

 

6.1           Medical/Scientific

Product Inquiries:

 

(a)                                  BI shall be solely responsible for responding to all medical questions

and inquiries relating to the Licensed Products in each country in the

Territory.

 

(b)                                 In conjunction with the marketing and sale of Licensed Products in a

country in the Territory, BI shall be solely responsible for providing (i)

medical, technical and scientific information concerning Licensed Product to

healthcare professionals, managed care organisations, sales representatives,

medical publishers, consumers, patient assistance programs and others who may

request such information, and (ii) after-hours coverage to address emergency

requests for medical, technical and such scientific information concerning the

Licensed Products.

 

6.2           Adverse Medical Events and

Complaints:

 

BI agrees to

provide ImmunoGen with Adverse Event information and product complaint

information relating to Licensed Products as compiled and prepared by BI in the

normal course of business in connection with the development, commercialization

or sale of any Licensed Product, within time frames consistent with reporting

obligations under applicable laws and regulations. [ *

] agrees to [ * ] with [ * ] and [ * ] to[

* ] that is [ * ] and [ * ] by [ * ] or [ * ] in the

normal course of business in connection with the [ * ] or [ * ] of any such[ * ], within time frames consistent with reporting obligations under

applicable laws and regulations; provided, however, that the foregoing shall

not require [ * ] to [ * ]any[ * ] with or [ * ] owed to[ * ]. 

ImmunoGen, in [ * ] in which it has [ * ]or [

* ] a [ * ] under the [ * ] and[ * ],[

* ]or[ * ], as the case may be, a [ * ] to [ * ] of [ * ] to the [ * ] that is

the [ * ] of such[ * ].[ * ] will [ * ] and [ * ] these [ * ] and will [ * ] to [ * ] all [ * ]which is

relevant for the [ * ] of the [ * ] and its

[ * ] to[ * ].  [ * ]hereby affirms to [ * ] that such [ * ] is not [ * ] the [ * ] owes to[ * ].  BI shall provide its Adverse Event and

product complaint information hereunder to ImmunoGen’s designated

representative, who shall be its Chief Regulatory Officer unless ImmunoGen

otherwise notifies BI. [ * ] shall [ * ] its [ * ]and [ * ] hereunder to [ * ] designated representative, who shall be the

head of its Drug Safety group in [ * ] unless [ * ]

otherwise notifies[ * ].

 

15

 

7.             RIGHTS

AND IMPROVEMENTS

 

7.1           Ownership of Technology and Proprietary Materials:

 

All BI Intellectual

Property and BI Materials shall be sole and exclusive property of BI and may be

used by BI in any manner BI, in its sole discretion, deems appropriate to

exercise its rights under this Agreement. 

All Licensed Technology and ImmunoGen Materials shall be sole and exclusive

property of ImmunoGen and may be used by ImmunoGen in any manner ImmunoGen, in

its sole discretion, deems appropriate, to exercise its rights under this

Agreement, subject to the grant of the licenses to BI described in this

Agreement.

 

7.2           [ * ]:

 

(a)                                  [ * ]will [ * ]to [

* ]any and all [ * ]or [ * ]or [ * ]it or [ * ]under

its [ * ] during [ * ] of this Agreement to the extent such [ * ] are related to [ * ] or are [ * ] or [ * ] to [ * ] and[ * ].

 

(b)                                 To the extent any [ * ] was [ * ] or [ * ] or [ * ] and [ * ] (a “[ * ] ”), such [ * ] shall be [ * ] by [ * ] and[ * ]. 

ImmunoGen and BI each hereby represents that all employees and other

persons acting on its behalf in performing its obligations under this Agreement

shall be obligated under a binding written agreement or the applicable law to [ * ] to it or as it [ * ]all [ * ] or [ * ] by such employees or other persons.

 

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

 

8.             PATENTS

AND TRADEMARKS

 

8.1           Patent Prosecution:

 

(a)                                  ImmunoGen agrees to use commercially reasonable effort to continue, [ * ] , the

prosecution and maintenance of the Licensed Patent Rights; provided, however,

that ImmunoGen shall keep BI fully and timely informed in respect of the course

and conduct of patent application prosecution matters pertaining to Licensed

Products. Prosecution and maintenance of Licensed Patent Rights shall include,

but not be limited to, prosecuting pending patent applications therein and

maintaining and extending patents therein, including in any defensive

proceedings such as oppositions and the like and any reissue or re-examination

proceedings, in any country in the Territory should such actions be reasonably

deemed necessary or desirable by ImmunoGen. ImmunoGen shall keep BI advised of

the status of such prosecution and maintenance by timely providing BI with

copies of all patent applications and patents, and all official communications

with respect to such patent applications and patents, contained in the Licensed

Patent Rights for the purpose of obtaining substantive comment of BI patent

counsel.

 

16

 

(b)                                 As regards any Patent Rights covering Joint Improvements, ImmunoGen

will have the first right, but not the obligation, to undertake filing(s), prosecution

and maintenance of inventorship certificate(s), patent application(s) and

patent(s) thereon. ImmunoGen shall advise BI within [ * ] whether it will file any such patent

application with respect to any Joint Improvements.  If ImmunoGen fails to undertake the filing(s) of any such patent

application within [ * ]

after receipt of written notice from BI that it believes filing(s) of such an

application by ImmunoGen is appropriate, BI may undertake such filing(s) at its

own expense.   In connection with any

such filing(s), the filing party will file, prosecute and maintain such patent

application in the name of both parties jointly.    In any case, the filing party (i) will provide the non-filing

party with a copy of any such proposed patent application for review and

comment reasonably in advance of filing, and (ii) will keep the non-filing

party reasonably informed of the status of such filing, prosecution and

maintenance.  Costs of any such filing,

prosecution and maintenance shall be shared jointly by the parties.

 

8.2           Patent Abandonment:

 

If ImmunoGen elects

to abandon any patent application or patent included within the Licensed Patent

Rights, and/or terminate its future obligations to prosecute and maintain any

such patent application or patent, then it shall provide BI with [ * ] prior written notice of its

election.  If BI notifies ImmunoGen

within such [ * ]

response period, that it wishes to prosecute or maintain such patent

application or patent at its own expense, then ImmunoGen shall promptly transfer

and assign such patent application or patent to BI and continue to prosecute

and maintain such patent application or patent or until such transfer and

assignment become effective. Upon such transfer and assignment becoming

effective, such patent application or patent shall no longer be considered to

be included within the Licensed Patent Rights, and ImmunoGen and its employees

shall thereafter reasonably assist BI in the prosecution and maintenance of

such patent application or patent; provided, however, that such assistance

shall be subject to BI's reimbursement of ImmunoGen's out-of-pocket expenses

with respect thereto.

 

8.3           Trademarks:

 

BI, in its sole discretion, in its own name

and at its own expense, may prepare or develop, adopt and register all

trademarks, trade names, brand names and logos for use with the Licensed

Products. These trademarks, trade names, brand names and logos shall be and

shall remain the sole and exclusive property of BI. All use of such trademarks,

trade names, brand names and logos shall inure to the sole benefit of BI. BI

shall remain the owner of the trademarks, trade names, brand names and logos

and the goodwill associated with the same and ImmunoGen agrees not to assert

any ownership interest in such trademarks, trade names, brand names and logos

or the goodwill associated therewith.

 

17

 

9.             INFRINGEMENT

 

9.1           Infringement of Third Parties’ Rights:

 

(a)                                  Notice. 

If the development, registration, manufacture, use, marketing or sale of

the Licensed Products results in a claim against a party of infringement or

misappropriation of any third party’s patent or other intellectual property

right (“Third-Party Claim”), the party first having notice of a Third-Party

Claim shall promptly notify the other party in writing specifying in reasonable

detail the alleged grounds or basis for the Third-Party Claim (to the extent

known).

 

(b)                                 Patent

Infringement Claims.  If the development, registration,

manufacture, use, marketing or sale of Licensed Products in a country in the

Territory results in a Third-Party Claim of patent infringement, the parties

agree to respond to and/or defend against the Third-Party Claim as follows:

 

(i)                                     Control of Defence. 

ImmunoGen shall have the initial right to manage solely the defence of

the parties against the Third-Party Claim. 

If ImmunoGen elects to exercise such right as to the Third-Party Claim,

BI shall cooperate with ImmunoGen at ImmunoGen’s request and shall have the

right to be represented by counsel selected and paid for by BI.  If ImmunoGen elects not to exercise such

right as to the Third-Party Claim, BI shall have the right to manage solely the

defence of the parties against the Third-Party Claim and ImmunoGen shall

cooperate with BI at BI’s request and shall have the right to be represented by

counsel selected by ImmunoGen.

 

(ii)                                  Settlements.  The

party that manages solely the defence of the parties against the Third-Party

Claim shall also have the right to settle such Third-Party Claim on terms

deemed appropriate by such party provided, however, that (A) neither party shall settle

any Third-Party Claim in a manner that is prejudicial to the Licensed Products, (B) such

party shall consult with the other party concerning the terms of any settlement

agreement before entering into such an agreement, and (C) neither party shall settle

any such Third-Party Claim without the prior written consent of the other

party, which consent shall not be unreasonably withheld.

 

(iii)                               Costs of Defence.  Each

party shall be responsible for its own fees and costs of attorneys and

consultants, together with the court costs, incurred in defending against the

Third-Party Claim.

 

9.2           Infringement Claims against Third

Parties:

 

ImmunoGen agrees during the Term of this Agreement to

take reasonable actions to protect the Licensed Patent Rights from infringement

and the Licensed Technology from unauthorised possession or use.

 

(a)           A party first having knowledge of any

infringement or misappropriation, or knowledge of a reasonable probability of

such infringement or misappropriation, by a third party, including that

contained in a notice provided under the 1984 Act by a party filing an ANDA or

Paper NDA for Licensed Products, or an equivalent action in any other country

of the world, shall promptly notify the other party in writing. ImmunoGen shall

institute, prosecute, and control, at its own expense and with counsel of its

own choosing, any action or proceeding against the third party with respect to

such infringement or misappropriation, and keep BI informed of the progress of

such enforcement proceeding and shall give due consideration to the suggestions

or comments of BI in connection therewith.

 

 

18

 

(b)                                 If ImmunoGen fails to act within a period of [ * ] after receiving notice of the

infringement in a country in the Territory, BI shall have the right to bring

and control, at its own expense, any such action by counsel of its own

choice.  If BI brings any such action or

proceeding, ImmunoGen may be joined as a party plaintiff and ImmunoGen agrees

to give BI reasonable assistance to file and to prosecute such suit.

 

(c)                                  To the extent that ImmunoGen or BI initiates

and prosecutes a proceeding under Section 9.2 on its own, without the material

assistance of or the participation as a co-plaintiff in the action by the other

party, then the party that prosecuted the action shall be entitled to retain

for its sole and exclusive benefit any damages or other monetary award

recovered therein in its favour.

 

(d)                                 To the extent that both ImmunoGen and BI materially assist or

participate in, or, pursuant to Section 9.2(b) above, are both parties to, any

such proceeding, then:

 

(i)                                     the costs and expenses of each of ImmunoGen and BI under this Section

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

 

(ii)                                  the amount of any [ * ] or other[ * ] therein in favour of ImmunoGen and/or BI, in

excess of the [ * ] provided

for in clause (i) above, shall be [ * ] as follows: 

(1) first, to[ * ], as [ * ] for [ * ]associated with [ * ] and to [ * ] as [ * ] for [ * ] to the

extent that the [ * ] or [ * ] is [ * ] to [ * ] associated with[ * ]; and (ii) second, any amounts remaining shall be allocated as follows:

(a) if [

* ] is the party

prosecuting such action, [ * ] to[

* ], (b) if [ * ] is the party prosecuting such

action, [

* ] to [ * ] and [ * ] to[ * ], and (c) if both parties are prosecuting such action, [ * ] to[ * ].

 

10.          REPRESENTATIONS

AND WARRANTIES

 

10.1         ImmunoGen Representations:

 

ImmunoGen

represents and warrants to BI that:

 

(a)                                  No Conflict. The execution, delivery and performance of

this Agreement by ImmunoGen does not conflict with any agreement, instrument or

understanding, oral or written, to which it is a party or by which it may be

bound, and does not violate any law or regulation of any court, governmental

body or administrative or other agency having

authority over it, including, without limitation, 35 U.S.C.A. Sections 203 and

204.  ImmunoGen is not currently a party

to, and during the Term of this Agreement will not enter into, any agreements,

oral or written, that are inconsistent with its obligations under this

Agreement.

 

19

 

(b)                                 Authority. ImmunoGen is validly existing and

in good standing under the laws of the state of its incorporation and has the

corporate power and authority to enter into this Agreement. The execution,

delivery and performance of this Agreement have been duly authorized by all

necessary action on the part of ImmunoGen, its officers and directors.

 

(c)                                  Ownership. To ImmunoGen’s knowledge, all of

the Licensed Patents are subsisting and are valid and enforceable. ImmunoGen

(i) has not previously assigned, transferred, conveyed or otherwise encumbered

its right, title and interest in Licensed Patents, or any component of the

Licensed Technology, and (ii) has no knowledge of the existence of any

patent, trademark or other intellectual property right (other than any patent

application) owned or controlled by ImmunoGen, other than the Licensed Patent

Rights, in case of either (i) or (ii), that would prevent ImmunoGen and BI from

manufacturing and supplying Licensed Products, and BI from exploiting its

rights granted under Section 2.1.  In

addition, ImmunoGen has no knowledge of the existence of any patent or

intellectual property right (other than any patent application) owned or

Controlled by a third party that would materially conflict with the grant of

the license set forth in Section 2.1 of this Agreement.

 

(d)                                 Litigation. There are no claims, judgements or

settlements against, pending with respect to the Licensed Patents or any

component of Licensed Technology. In addition, to ImmunoGen's knowledge, no

such claims, judgements or settlements are threatened.

 

(e)                                  Further Warranties:

 

ImmunoGen covenants

to BI that:

 

(i)                                     The development and manufacture of DM1 by

ImmunoGen under this Agreement shall be in compliance with the laws, requirements

and regulations applicable thereto in the Territory.

 

(ii)                                  The documentation to be provided to BI pursuant

to Section 5.2 will, at the time of transfer to BI, contain all material

know-how and information then in ImmunoGen’s Control relating to the production

of Licensed Products.

 

(iii)                               All Certificate of Analysis documents which

will be provided to BI under this Agreement shall be generated and documented

in accordance with generally accepted standards of the pharmaceutical industry.

 

20

 

(iv)                              All[ * ], submitted to [ * ] by [ * ] in [ * ] to[ * ], regarding Licensed Technology and Licensed

Patent Rights is, to the best of ImmunoGen’s knowledge, accurate in all

material respects.

 

10.2         BI Representations and Warranties:

 

BI represents,

warrants and covenants to ImmunoGen that:

 

(a)                                  No Conflict. The execution, delivery and performance of

this Agreement by BI does not conflict with any agreement, instrument or

understanding, oral or written, to which it is a party or by which it may be

bound, and does not violate any law or regulation of any court, governmental

body or administrative or other agency having authority over it.  BI is not currently a party to, and during

the term of this Agreement will not enter into, any agreements, oral or

written, that are inconsistent with its obligations under this Agreement.

 

(b)                                 Authority. BI is validly existing and in good standing

under the laws of the state of its incorporation and has the corporate power

and authority to enter into this Agreement. The execution, delivery and

performance of this Agreement have been duly authorized by all necessary action

on the part of BI, its officers and directors.

 

10.3         Warranty Disclaimer.

 

Except as otherwise

expressly provided in this agreement, neither party makes any warranty with

respect to any technology, goods, services, rights or other subject matter of

this Agreement and hereby disclaims warranties of merchantability, fitness for

a particular purpose and noninfringement with respect to any and all of the

foregoing.

 

11.          INDEMNIFICATION

 

11.1         Indemnification

by the Parties:

 

Each party (the

"Indemnitor") will indemnify the other party (the

"Indemnitee") against any liability in connection with any claim,

suits, liabilities, etc. arising out of the performance by the Indemnitor of

its work under the Agreement or the exploitation by the Indemnitor of its

rights under the Agreement, including, without limitation, the development,

manufacture, promotion, or sale of Licensed Products, unless such liability

results from (i) the negligence or wilful misconduct of the Indemnitee or (ii)

a breach of the warranties set forth in the Agreement by the Indemnitee.

 

11.2         Indemnification Procedures:

 

(a)                                  The Indemnitee shall: (i) notify the Indemnitor

of any liability and full details of the basis therefor with respect to which

the Indemnitee intends to claim indemnification as soon as practicable after

the Indemnitee becomes aware of any such liability; (ii) permit the Indemnitor

to assume the defence thereof; and (iii) cooperate with the Indemnitor, at the

Indemnitor’s expense, in the defence thereof.

 

21

 

(b)                                 With respect to any matter for which the

Indemnitor has an obligation to indemnify the Indemnitee under this Agreement,

the Indemnitee shall have the right to participate and be represented (at the

Indemnitor’s expense) by legal counsel of the Indemnitee’s choice in all

proceedings and negotiations, if representation by counsel retained by Indemnitor

would be inappropriate due to actual or potential differing interests between

the Indemnitee and any other party represented by such counsel in such

proceedings.

 

(c)                                  The indemnity agreement in this Section 11

shall not apply to amounts paid in settlement of any liability if such

settlement is effected without the consent of the Indemnitor, which consent

shall not be unreasonably withheld.

 

(d)                                 Failure of the Indemnitee to deliver notice to

the Indemnitor within thirty (30) days after becoming aware of a liability

shall relieve the Indemnitor of any liability to the Indemnitee pursuant to

this Section 11 in the event, but only to the extent, such delay is prejudicial

to the Indemnitor’s ability to defend such action.

 

12.          CONFIDENTIALITY

 

12.1         Confidential Information:

 

All data,

information, documents and materials transmitted by BI to ImmunoGen or by

ImmunoGen to BI in conjunction with this Agreement, including, but not limited to, all scientific, technical and clinical data,

information reports, financial or business records, forecasts, orders,

summaries and information gathered, generated or transferred by a party during

the course of this Agreement is considered confidential and proprietary

information of the disclosing party (hereinafter “Confidential Information”).

The parties shall use the Confidential Information only for the purpose of

executing their rights and fulfilling their obligations under this Agreement.

 

12.2         Disclosure:

 

(a)                                  Upon execution of this Agreement and thereafter

on an ongoing basis during the Term of the Agreement, each party shall disclose

to the other party, in confidence, subject to the terms of this Section 12,

information required by the other party in order to execute its rights and

fulfil its obligations pursuant to this Agreement. Notwithstanding the

foregoing, a party shall not be obligated to disclose to the other party any

information that it is prohibited from disclosing to the other party, either by

reason of a contract with a third party or by law. In the event of such a

restriction, the parties shall cooperate and take such legally permissible

action as may be reasonable to permit such disclosure to be made.

 

(b)                                 The receiving party shall not disclose, without

prior written consent of the disclosing party, any Confidential Information to

any third party other than officers, directors, Affiliates and representatives

of the receiving party and to third parties mentioned in Section 2.4. When the

receiving party does disclose information, it will only be on a need to know

basis, including, without limitation, fulfilment of corporate reporting

required by law or regulation, hospital authorities, regulatory authorities and

others who have agreed in writing to observe the confidentiality of

Confidential Information in the same manner and to the same extent as provided

in this Section 12.

 

22

 

12.3         Publications

 

(a)                                  In recognition of BI’s assumption of

development and marketing responsibilities in connection with the Licensed

Product, and in order to assure consistency with BI’s marketing plans, except

for submissions of manuscripts, abstracts or other publications made prior to

the Effective Date, ImmunoGen, its Affiliates, their employees, clinical

investigators or consultants shall not have the right to make any public

disclosure of information, whether oral or in writing, concerning the

pre-clinical and/or clinical trial activities and/or results pertaining

specifically to Licensed Products without the express written consent of BI,

which consent may be withheld in BI’s sole discretion.  BI shall be entitled to publish scientific

information and data, including the results of clinical trials, as it deems

appropriate, to advance the commercialization of the Licensed Product, subject

to subsection (b) below.

 

(b)                                 Notwithstanding the foregoing, BI shall consult with ImmunoGen prior to

the submission of any manuscript for publication if the publication will

contain any Confidential Information of ImmunoGen, unless the applicable laws

and regulations prohibit such consultation. 

Such consultation shall include providing a copy of the proposed

manuscript to ImmunoGen at least [ * ] prior to the proposed date of

submission to a publisher, incorporating appropriate changes proposed by

ImmunoGen regarding its Confidential Information into the manuscript submission

and deleting all Confidential Information of ImmunoGen as it may request;

provided, however, that ImmunoGen’s review hereunder shall be deemed completed

at the end of such [ * ]period.

 

12.4         Obligation to Obtain Agreements:

 

The obligations of

the receiving party regarding the confidentiality and nondisclosure of

Confidential Information shall extend to and be binding upon all employees or

agents of the receiving party who have access to Confidential Information

pursuant to this Agreement as if such employees or agents were parties hereto.

 

12.5         Exceptions:

 

The obligations of the receiving party regarding the

confidentiality and nondisclosure of information as provided in this Section 12

shall not apply to certain information if it can be demonstrated by written

documentation or other adequate proof that such information:

 

(a)                                  Is already known to the receiving party as

shown by competent written records;

 

(b)                                 Is or becomes publicly available through no

fault of the receiving party;

 

23

 

(c)                                  Is disclosed to the receiving party by a third

party not subject to an obligation of confidentiality to the disclosing party

respecting such information;

 

(d)                                 Is required to be disclosed by law, regulation,

order, decree or subpoena or other legal process; provided that the receiving

party has used reasonable efforts to obtain a protective order and has taken

reasonable actions to avoid further disclosure of such information to any party

not part of such requirement; or

 

(e)                                  Is independently developed by the receiving

party without reliance on information provided by the disclosing party as shown

by competent written records.

 

12.6         Public Disclosure:

 

Neither ImmunoGen

nor BI shall issue a press release or in any other way announce to the public

the existence, terms, conditions of, or performance under this Agreement

without the prior written consent of the other party, which consent shall not be

unreasonably withheld or delayed, unless the existence, terms, conditions of,

or performance under this Agreement is required to be disclosed by law,

regulation, order, decree or subpoena or other legal process; provided that the

party ordered to so announce has used reasonable efforts to obtain a protective

order or other applicable protection against further disclosure or release or

announcement of such information.  The

parties shall mutually agree on the text of a press release announcing the

execution of this Agreement and on any confidential treatment request(s) to be

filed with the Securities and Exchange Commission with respect to this

Agreement.  Once any written text is

approved for disclosure by both parties as provided herein, either party may make

subsequent or repeated public disclosures of the contents thereof without the

further approval of the other party. 

Nothing in the foregoing, however, shall prohibit a party from making

such disclosures regarding this Agreement or the terms thereof to the extent

deemed necessary under applicable federal or state securities laws or any rule

or regulation of any nationally recognized securities exchange, subject to the

terms of Section 12.5 above regarding disclosures required to comply with

applicable laws, regulations or court order.

 

13.          TERM

AND TERMINATION

 

13.1         Term:

 

Unless earlier terminated pursuant hereto, the term of

this Agreement (the “Term”) shall continue on a country-by-country basis

through the last to expire of any obligation of BI to pay a royalty to

ImmunoGen hereunder in such countries in the Territory. However, in the

European Union the obligation of ImmunoGen not to license or exploit by itself

the Licensed Technology shall expire on a country-by-country basis after

expiration of the Licensed Patent Rights in the respective country or after [ * ] from [ * ] of the respective Licensed Product,

whichever is the longer.

 

13.2         Early Termination:

 

Notwithstanding Section 13.1, either party may, in

addition to exercising any other 

available legal or equitable rights or remedies, terminate this

Agreement, effective immediately upon the expiration of any applicable cure

period, upon the occurrence of an Event of Default (as defined below) with

respect to the other party.  The term

“Event of Default” with respect to a party means the occurrence of any of the

following events:

 

24

 

 

(a)                                  The failure of a party to comply with or perform any material provision

of this Agreement, and such failure remains uncured for [ * ] following written notice of such failure (if such default is cured

within the cure period, such written notice shall be null and void), provided

that, if the defaulting party can establish to the reasonable satisfaction of

the other party that it is diligently and actively pursuing a cure at the

expiration of the cure period, and that the default is reasonably capable of

being cured, then the cure period shall be extended for so long as a cure is

being diligently and actively pursued, not to exceed [ * ] and [ * ] in the aggregate.

 

(b)                                 A party (i) becomes unable to pay its debts as they

mature, (ii) is the subject of a voluntary or involuntary petition in

bankruptcy or of any other proceeding under bankruptcy, insolvency or similar

laws which, if involuntary, is not dismissed within [ * ] of the date filed, (iii) makes an assignment

for the benefit of creditors, (iv) is named in, or its property is subject to,

a suit for the appointment of a receiver which is not dismissed within [ * ]of the date filed, or (v) is dissolved or

liquidated.

 

13.3         Termination by BI:

 

BI has the right to terminate this Agreement for any

reason at any time upon [ * ] advance written notice given to

ImmunoGen.

 

14.          EFFECTS OF TERMINATION

 

14.1         Further Licenses/Reversion of Rights:

 

(a)                                  Upon the expiration of this Agreement pursuant Section 13.1, on a

country by country basis, BI shall have a non-exclusive, irrevocable, fully

paid-up, royalty free license to use and exploit the Licensed Technology in

such country.

 

(b)                                 In the event this Agreement is terminated by BI in accordance with

Section 13.2(a) of this Agreement as a result of the grant by ImmunoGen to a

third party of a license under the Licensed Technology and/or Licensed Patent

Rights in violation of the exclusive license granted to BI under Section 2.1,

BI’s [ *

] under [ * ]  of this Agreement shall [ * ] a[

* ].

 

(c)                                  In the event this Agreement is terminated for

any other reason other than as described in Section 14.1(a) and (b) above, all

rights granted to BI under Section 2.1 shall terminate and revert to ImmunoGen.

 

14.2         Inventory:

 

If either party

terminates this Agreement, then BI shall have the right, within [ * ] after such termination, to sell off

its remaining inventory of Licensed Product and pay ImmunoGen all royalties on

account thereof.

 

25

 

14.3         Other Penalties:

 

(a)                                  Termination of this Agreement by either party

shall not prejudice the rights of such party under this Agreement, at law or in

equity or otherwise, to seek damages or injunctive relief for any breach of

this Agreement by the other party hereto and all payment obligations accruing

under this Agreement prior to the effective date of termination.

 

(b)                                 Except

as otherwise provided

in this Agreement, neither ImmunoGen nor BI will be liable with respect to any

subject matter of this Agreement under any contract, negligence, strict

liability or other legal or equitable theory for any punitive damages or

indirect, incidental, consequential damagesor lost profits, including, without

limitation, cost of procurement of substitute goods or technology, or loss of

opportunity, loss of income or compensation for loss of goodwill.

 

14.4         Accrued Rights:

 

Termination of this

Agreement for whatever reason shall not affect the accrued rights of either

ImmunoGen or BI arising under or out of this Agreement.  The obligations under any other provision

that expressly or by implication are intended to survive

expiration or termination shall survive expiration or termination of this

Agreement.

 

14.5         Confidential Information.

 

Upon the expiration

or termination of this Agreement, the receiving party will upon request from

the disclosing party promptly return to the disclosing party all of the

Confidential Information in the receiving party’s possession, as well as all

written information and materials that incorporate Confidential Information; provided,

however, that the receiving party may keep (i) all information and

material that incorporate Confidential Information necessary to exploit the

receiving party’s rights set forth in Section 14 and/or (ii) one (1) copy of

such Confidential Information, or as required by applicable laws, rules or

regulations, subject to the confidentiality provisions contained herein.

 

15.          MISCELLANEOUS

 

15.1                           Either party shall not be entitled to assign or

otherwise transfer its rights and obligations under this Agreement in whole or

in part to any third party without the prior written consent of the other

party.

 

15.2                           This Agreement set forth the entire agreement

between the parties and supersedes all previous agreements, written or oral

regarding the subject matter hereof. This Agreement may be amended only by an

instrument in writing duly executed on behalf of the parties.

 

15.3                           Neither party shall be liable for delay or failure to perform hereunder

due to any contingency beyond its control, including but not limited to acts of

God, fires, floods, wars, civil wars, sabotage, strikes, governmental laws,

ordinances, rules or regulations or failure of third party delivery, provided,

such party promptly gives to the other party hereto written notice claiming for

force majeure and uses its best efforts to eliminate the effect of such force

majeure, insofar as is possible and with all reasonable dispatch. If the period

of delay or failure should extend for more than [ * ] then either party shall have the right to terminate this Agreement

forthwith upon written notice at any time after expiration of said [ * ] period.

 

26

 

15.4                           Any waiver shall be made in writing for it to

be effective and unless expressly stated shall not be a continuing waiver nor

shall it prevent the waiving party from acting upon that or any subsequent

breach or from enforcing any term or condition of this Agreement.

 

15.5                           The invalidity of any provision of this

Agreement or any loophole in this Agreement shall not affect the validity of

any other provision hereof. The parties undertake to replace the invalid

provision or close the loophole in the Agreement with another provision which

reflects legally the originally intended commercial objectives of the parties

as closely as possible.

 

15.6                           This Agreement shall be governed exclusively by[ * ]. In the event of any controversy or

claim arising out of or relating to any provision of this Agreement, the

parties shall first try to settle those conflicts amicably between themselves.

Any dispute, controversy or claim initiated by either party arising out of,

resulting from or relating to this Agreement, or the performance by either

party of its obligations under this Agreement (other than bona fide third party

actions or proceedings filed or instituted in an action or proceeding by a

third party against a party), whether before or after termination of this

Agreement, shall be finally resolved by binding arbitration.  Whenever a party shall decide to institute

arbitration proceedings, it shall give written notice to that effect to the

other party.  Any such arbitration shall

be conducted under the commercial arbitration rules of the ICC by a panel of

three arbitrators appointed in accordance with such rules.  Any such arbitration shall be held in[ * ]. 

The arbitrators shall have the authority to grant specific performance

and to allocate between the parties the costs of arbitration in such equitable

manner as they determine.  Judgment upon

the award so rendered may be entered in any court having jurisdiction or

application may be made to such court for judicial acceptance of any award and

an order of enforcement, as the case may be. 

In no event shall a demand for arbitration be made after the date when

institution of a legal or equitable proceeding based upon such claim, dispute

or other matter in question would be barred by the applicable statute of

limitations.  Notwithstanding the

foregoing, either party shall have the right, without waiving any right or

remedy available to such party under this Agreement or otherwise to seek and

obtain from any court of jurisdiction any interim or provisional relief that is

necessary or desirable to protect the rights or property of such party, pending

the selection of the arbitrators hereunder or pending the arbitrators’

determination of any dispute, controversy or claim hereunder.

 

15.7                           In the performance of this Agreement each party

shall be an independent contractor, and therefore, no party shall be entitled

to any benefits applicable to any employee of the other party. No party is

authorised to act as an agent for the other party for any purpose, and no party

shall enter into any contract, warranty or representation as to any matter on

behalf of the other party.

 

27

 

16.          SCHEDULES

 

A reference to the terms of

this Agreement shall be meant to include all Schedules.  The following Schedules are incorporated and

made part of this Agreement:

 

Schedule A.  Licensed Technology

 

Schedule B.  Licensed Patent Rights

 

Schedule C.  BI Intellectual Property

 

Schedule D.  Provision of Non-clinical BIWI1

 

Schedule E.  Major Terms of Technical Transfer Plan

 

Schedule F:  Development Plan

 

Schedule G.  Clinical Supply Agreement

 

[Remainder of page intentionally left blank]

 

28

 

IN WITNESS WHEREOF,

the parties hereto have caused this Agreement to be executed in triplicate by

their duly authorised representatives.

 

	

  Boehringer Ingelheim

  International GmbH

  	

  ImmunoGen, Inc.

  
	

  ppa.

  	

   

  
	

   

  	

   

  
	

   

  	

   

  	

   

  	

   

  
	

  Dr. K. Wilgenbus

  	

  Claudia Jesse

  	

   

  	

  Pauline Jen Ryan

  	

   

  
					

 

29

 

Schedule A

Licensed Technology

 

[ * ] (including [ * ] for [ * ] of[

* ],[ * ]of [ * ]to[ * ],[

* ]of[ * ],[ * ]of [ * ] to[

* ],[ * ] of[ * ], and [ * ] of [ * ] and [ * ] and [ * ] in biological material and in Drug Substance

and Drug Product preparations).

 

A-1

 

Schedule B

Licensed Patent Rights

 

[ * ]

 

	

  Attorney

  Reference No.

  	

  Country

  	

  Appl. No.

  	

  Filing

  Date

  	

  Priority

  Date

  	

  Patent No.

  	

  Issue Date

  	

  Exp. Date

  
	

   

  	

   

  	

   

  	

   

  	

   

  	

   

  	

   

  	

   

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

   

  	

  [ * ]

  	

   

  	

   

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  
	

   

  	

   

  	

   

  	

   

  	

   

  	

   

  	

   

  	

   

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  
	

   

  	

  [ * ]

  	

   

  	

   

  	

   

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

   

  	

   

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  
	

   

  	

   

  	

   

  	

   

  	

   

  	

   

  	

   

  	

   

  

 

[ * ]

 

	

  Attorney

  Reference No.

  	

  Country

  	

  Appl. No.

  	

  Filing

  Date

  	

  Priority

  Date

  	

  Patent No.

  	

  Issue Date

  	

  Exp. Date

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

   

  	

  [ * ]

  	

   

   

  	

   

   

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

   

  	

   

  

 

 [ * ] (2)

 

	

  Attorney

  Reference No.

  	

  Country

  	

  Appl. No.

  	

  Filing

  Date

  	

  Priority

  Date

  	

  Patent No.

  	

  Issue Date

  	

  Exp. Date

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

   

  	

  [ * ]

  	

   

   

  	

   

   

  

 

[ * ]

 

	

  Attorney

  Reference No.

  	

  Country

  	

  Appl. No.

  	

  Filing

  Date

  	

  Priority

  Date

  	

  Patent No.

  	

  Issue Date

  	

  Exp. Date

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

   

   

  	

   

   

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  

 

B-1

 

Schedule C

BI Intellectual Property

 

	

  [ * ]

  	

  Subject

  	

  Expiry and Status Europe

  	

  Expiry and Status US

  	

  File No. EP 

  and US

  	

  Geographic Coverage

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  

 

C-1

 

Schedule

D

Provision of [ * ]

 

	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  
	

  [ * ]

  	

  [ * ]

  	

   

  	

   

  	

   

  
	

  [ * ]

  	

  [ * ]

  	

   

  	

   

  	

   

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

   

  	

   

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

   

  	

   

  
	

  [ * ]

  	

   

  	

   

  	

  [ * ]

  	

  [ * ]

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

   

  	

   

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

   

  	

   

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

   

  	

   

  
	

  [ * ]

  	

  [ * ]

  	

   

  	

   

  	

   

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  
	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  
	

  TOTAL

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  	

  [ * ]

  

 

D-1

 

Schedule E

Major Terms of [ * ]

 

It is the intention of the

parties that the [ * ] referenced in Section [ * ]  of this Agreement will be

finalised by the parties as soon as practicable and in any event no later than[ * ]. 

Both parties agree to negotiate such finalized terms in good faith,

which shall be based on the [ * ] by [ * ] to [ * ] of following documentation, to the

extent available:

 

For [ * ]

purposes:

 

[ * ]:

•               [

* ]and [ * ]for [ * ]of the [ * ]covering [ * ] and [ * ] ([

* ]for

[ * ]including[ * ])

•               [ * ]and [ * ] for [ * ] covering [ * ] for[ * ],[ * ]and [

* ]

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

•               [

* ]of the [ * ]

•               [

* ]of [ * ] for [ * ]

•               [

* ]for[ * ] ([ * ])

•               [

* ]of all[ * ] of[ * ]

•               [

* ]for [ * ]([ * ]and [

* ]

conditions)

 

[ * ]:

•               [

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

•               [

* ]of [ * ]([ * ])

•               [

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

* ])

 

For [ * ]Purposes:

 

•               [

* ]of [ * ]([ * ])

•               [

* ]for [ * ]

•               [

* ]for [ * ](see below)

•               [

* ] ([ * ])

of each [ * ](see below)

 

[ * ]of “[

* ]”:

•               [

* ]

•               [

* ]

•               [

* ]

•               [

* ]

•               [

* ]

•               [

* ]

•               [

* ]

 

For[ * ] purposes:

 

ImmunoGen will [ * ]BI with [ * ]that

are [ * ]for [

* ](e.g. [ * ]etc.).

ImmunoGen will [ * ]BI with all required [ * ]and

[ * ]on [

* ]of[ * ].

 

E-1

 

For [ * ]purposes:

 

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

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

•    [ * ]of [ * ]used in the [ * ]

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

* ])

•    [ * ]regarding the [ * ]

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

necessary [

* ]

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

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

* ]

•    [ * ]of each [ * ](i.e. [ * ]of [

* ]of the [ * ]when [ * ]in the [ * ]for example[ * ])

 

General:

 

ImmunoGen will

agree to [

* ]for the

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

 

ImmunoGen will

agree, [ * ] , to [ * ] an [ * ] of [ * ] from BI at [ * ] during the [ * ] in order to [ * ] such [ * ] in the [ * ] of the [ * ] and [ * ] that are [ * ] for the [ * ] of[ * ].  Such [ * ] shall take place at [ * ] at mutually convenient times and shall not

exceed an aggregate of in duration.  BI

shall [ *

] the [ * ] and [ * ] of all such[ * ].  

ImmunoGen will also agree to let BI [ * ] the [ * ]of at least [ * ] of[

* ].

 

ImmunoGen will

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

 

On not less than [ * ] prior written notice from BI,

ImmunoGen will also agree to [ * ]to the [ * ] for a [ * ] not to exceed [ * ] in the aggregate, while the [ * ] is being[ * ]. BI will have the right to [ * ] to ImmunoGen as to the [ * ] and [ * ] of such [ * ] desired as well as the [ * ] of such[ * ]. To the extent practicable, ImmunoGen will

attempt to [ * ] in such

[ * ] who have [ * ] on the[ * ]. 

ImmunoGen and BI will agree to negotiate in good faith any [ * ] of such[ * ].  BI

will agree to [ * ]

ImmunoGen for all of its [ * ] in connection with such [ * ] at [ * ] of [ * ] for[ * ], and [ * ]for [ * ]and[ * ], such as[ * ], will also be [ * ] by BI.

 

It is the [ * ] of the [ * ] that this [ * ] will [ * ] as soon as BI Pharma [ * ] of [ * ]which

comply with [ * ] and are

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

 

E-2

 

Schedule F

[ * ]for [ * ]

 

Initial[ * ]:

 

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

Strategy: [ * ] and [ * ] will be based on

the [ * ]

developed during [ * ]

and[ * ],

with [ * ] in

[ * ] to take

account of increasing [

* ] as well as[

* ]. No [ * ]

to the [ * ]

(eg., [ *

]) are envisaged during this[ * ].

 

[ * ]and

[ * ]                  [ * ]             ([ * ])

                                                        [[ * ]]

 

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

 

[ * ]                  [ * ];

                                                        [ * ]to be[ * ].

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

 

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

 

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

 

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

 

[ * ]                  [ * ]at [ * ]

                                                        [ * ]

 

[ * ]to

[ * ]                  [ * ]at [ * ]

 

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

 

[ * ]to

[ * ]                  [ * ]at [ * ]

 

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

 

[ * ]                                            [ * ]at [ * ]

 

ASSUMPTIONS:

(a)               [ * ]will

[ * ]of [ * ]for [ * ]([ * ]of [ * ]may be [ * ]for[ * ]),[ * ]at [ * ]to [ * ]are similar to

those obtained at[ * ].

(b)              [ * ]is[ * ].

 

F-1

 

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

include[ * ].

(d)              [ * ]that

[ * ]and [ * ]are [ * ]and [ * ]in a[ * ].

 

 

F-2

 

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

 

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

 

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

 

[ * ]for[ * ]:

 

[ * ]under way[ * ],

at[ * ].  This is an [ * ]to [ * ]a [ * ]for[ * ]. 

However, an [ * ]

was [ * ] for

[ * ] of [ * ] for [ * ]

 

[ * ]selected for [ *

] in[ * ].

 

[ * ]using the[ * ],

including [ * ]

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

 

[ * ]of[ * ]:    [ * ]of [ * ]to[ * ].

 

[ * ]to[ * ]:  [ * ]for[ * ].

 

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

 

[ * ]:  [ * ]of

[ * ]from [ * ]at[ * ].

 

[ * ]:   [ * ]of [ * ] for[ * ].

 

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

 

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

 

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

 

F-3

 

 [ * ]for [ * ]

 

[ * ]:[ * ]

that [ * ] is

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

 

[ * ]in the [ * ]

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

 

[ * ]from [ * ]

from the [ * ]

of [ * ] will

be [ * ] to [ * ] to [ * ] for [ * ] of [ * ]

 

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

 

 

F-4

 

Schedule G

CLINICAL SUPPLY AGREEMENT

 

This CLINICAL SUPPLY AGREEMENT (this “Agreement”) is

entered into as of November 27, 2001 (the “Effective Date”) by and between

ImmunoGen, Inc., a Massachusetts corporation having its principal office at 128

Sidney Street, Cambridge, Massachusetts 02139, USA (“ImmunoGen”), and

Boehringer Ingelheim Pharma KG, a company organized under the laws of Germany

having its principal office at Binger Strasse 173, 55218 Ingelheim am Rhein, Germany (“BI Pharma”). ImmunoGen and BI Pharma are sometimes referred to

individually herein as a “Party” and collectively as the “Parties.”

 

WHEREAS, Boehringer Ingelheim International

GmbH at Binger

Strasse 173, 55218 Ingelheim am Rhein, Germany (“BI”) and

ImmunoGen have contemporaneously entered into a Development and License

Agreement as of the Effective Date (the “License Agreement”), and BI Pharma is

an Affiliate of BI; and

 

WHEREAS, the License Agreement provides the

basis for the manufacture and supply of Drug Substance for non-clinical use to

BI or as directed by BI under the License Agreement and, moreover, states that

ImmunoGen and BI Pharma shall enter or have entered into contemporaneously a

supply agreement for the manufacture and supply of Drug Product for clinical

use (this “Agreement”) attached to that License Agreement as Schedule G;

and

 

WHEREAS, the Parties are in agreement that the

definitions used in the License Agreement and this Agreement shall have the

same meaning, force and effect, unless expressly otherwise provided for in this

Agreement; and

 

WHEREAS, ImmunoGen has agreed to supply BI

Pharma or as directed by BI Pharma with such quantities of Drug Product as BI

Pharma may reasonably request subject to the terms and conditions set forth

herein;

 

                NOW,

THEREFORE, in consideration of the mutual covenants contained herein, and for

other good and valuable consideration, the receipt of which is hereby

acknowledged, the Parties agree as follows:

 

1.              DEFINITIONS

 

Whenever used in this Agreement with an

initial capital letter, the respective terms shall have the meanings used in

the License Agreement and shall be incorporated by reference herein and the

terms defined in this Section 1 shall have the meanings specified hereinafter.

 

1.1           “BIWA4”

means unconjugated BIWA4 monoclonal antibody.

 

1.2           “Drug

Substance Batch” means a specific quantity of the Drug Substance

that is intended to be of uniform character and quality and is produced during

the same Batch Run.

 

 

G-1

 

1.3           “Drug

Product Batch” means a specific quantity of the Drug Product

that is intended to be of uniform character and quality and is produced during

the same aseptic filling campaign.

 

1.4           “Batch Run”

shall mean the production and purification process performed by ImmunoGen to

generate a Batch of Drug Substance pursuant to this Agreement.

 

1.5           “Calendar

Quarter” means each period of three consecutive calendar months

ending on March 31, June 30, September 30 or December 31.

 

1.6           “Calendar

Year” means each successive period of twelve months commencing

on January 1 and ending on December 31.

 

1.7           “Certificate

of Analysis” means a document, signed by an authorized

representative of ImmunoGen, describing specifications for, and testing methods

applied to Drug Product or Drug Substance, and the results thereof. A template

of the Certificate of Analysis is attached hereto as Schedule I.

 

1.8           “[   *   ]” shall mean with respect to any Drug

Product or Drug Substance, the [   *   ] of

producing (including the [   *   ] and [   *   ] of such Drug Product or Drug Substance, including the [   *   ] of the [   *   ] : (a) the [   *   ] , including [   *   ] and [   *   ] , of [   *   ] and [   *   ] such Drug Product or Drug Substance; (b) all[   *   ] incurred by ImmunoGen attributable to the [   *   ] under the foregoing clause (a), including [   *   ] and [   *   ]

which are [   *   ] to [   *   ] or [   *   ] or another [   *   ] ; (c) any other [   *   ] borne by ImmunoGen for the [   *   ] and/or [   *   ] of Drug Product or Drug Substance; and (d) [   *   ] and [   *   ] which are [   *   ] to [   *   ] or [   *   ] or another [   *   ] . [   *   ]  shall the [   *   ] to [   *   ] .  Notwithstanding the

foregoing, [   *   ] of Drug Product or Drug Substance [   *   ] (i) the [   *   ] of [   *   ] any [   *   ] to the extent [   *   ] by BI Pharma pursuant to Section [   *   ] of this

Agreement, (ii) the [   *   ] of [   *   ]

other than pursuant to Section [   *   ] of this Agreement, (iii) the [   *   ] of [   *   ] at [   *   ] pursuant to Section [   *   ]  of this Agreement, or (iv) any

[   *   ] to [   *   ] for [   *   ]

in the Facility. If [   *   ] as the

case may be can [   *   ] to [   *   ] that [   *   ] or [   *   ]

used for the [   *   ] of [   *   ] and/or [   *   ] of the [   *   ] and [   *   ] can be [   *   ]

at a [   *   ] than [   *   ] and [   *   ] or [   *   ] , or that [   *   ] can be [   *   ] on a [   *   ] and [   *   ]

, then [   *   ] shall [   *   ] such [   *   ] for the [   *   ] of the[   *   ].

 

1.9           “Draft

Specifications” means the preliminary written specifications

established for the characteristics, and quality as well as quality control

testing procedures for Drug Product or Drug Substance as the case may be, as

developed and mutually approved by the Parties in accordance with the License

Agreement, and attached hereto as Schedule A.  Draft Specifications shall dictate the manufacture of Drug

Product until such time as the Final Specifications (as hereinafter defined)

are agreed to by the Parties in accordance with Section 3.2.

 

1.10         “Drug

Product” means Drug Substance, manufactured under cGMP in the

final concentration for clinical use, aseptically filled in unlabeled, primary

packaging material.

 

1.11         “Drug

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

 

 

G-2

 

1.12         “Dedicated

Equipment”

means any equipment or machinery exclusively used by ImmunoGen in the

manufacturing of Drug Substance.

 

1.13         “Facility”

means ImmunoGen’s manufacturing facility used for manufacture of Drug Substance

located at 333 Providence Highway, Norwood, Massachusetts USA 02062 and all

equipment contained therein.

 

1.14         “Good

Manufacturing Practices” or “cGMP” means the current good

manufacturing practices applicable to the manufacturing of a Drug Product under

Title 21 of the United States Code of Federal Regulations as amended from time

to time.

 

1.15         “Final

Specifications” means the final written specifications

established for the characteristics, quality and quality control testing

procedures for Drug Substance or Drug Product, as developed and approved by the

Parties in accordance with Section 3.2 of this Agreement.

 

1.16         “Manufacturing

Process” means any and all processes (or a singular step in any

process) used or planned to be used by ImmunoGen for the manufacturing of Drug

Substance and Drug Product as described in Master Batch Records.

 

1.17         “Manufacturing

Documentation” shall mean all executed batch records and all

deviation reports and investigation reports associated with each individual

Batch Run.

 

1.18         “Master

Batch Record” means a written description of the Manufacturing

Process for Drug Substance or Drug Product, which shall be approved by BI

Pharma prior to start of production of the first cGMP Drug Substance or Drug

Product Batch. All such batch records shall include all technical requirements

and specifications with regard to the manufacturing methods, packaging process,

and storage methods and procedures, as applicable.

 

1.19         “[   *   ]”

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

 

1.20         “Transfer

Price” shall mean the price of any Drug Product to be invoiced

by ImmunoGen and payable by BI Pharma upon delivery of such Drug Product to BI

Pharma, which shall be determined in accordance with Section 7.1 hereof.

 

1.21         “Other

Definitions” shall have the meaning as defined in the respective

Sections enumerated below.

 

“Shipment Order”, see Section 3.4

 

“[   *   ] “, see Section [   *   ]

 

“Drug Product Forecast”, see Section 4.2

 

“Purchase Order”, see Section 4.3

 

“Laboratory”,

see Section 6.1.3

 

 

G-3

 

“Review”, see Section 6.1.2

 

“[   *   ]

”, see Section [   *   ]

 

“Term”, see Section 9.1

 

“Event of Default”, see Section 9.3

 

“Competent Authority”, see Section 11.3

 

“Indemnitor”, see Section 12.1.3

 

“Indemnitee”, see Section 12.1.3

 

2.             SCOPE OF AGREEMENT

 

2.1           Scope.

Any reference to a defined term or concept, including but not limited to those

relating to the supply of Drug Product, financial terms, intellectual property,

indemnification, termination or governance, not specifically contained in or

otherwise addressed by this Agreement shall be governed by the terms and

conditions as set forth in the License Agreement and, as such, any and all

terms and conditions of the License Agreement shall be

incorporated by reference herein.

 

2.2           Objective.

The overall objective of this Agreement is to govern the terms and conditions

pursuant to which ImmunoGen will produce for (or will have produced for as

permitted herein) and supply to BI Pharma or as directed by BI Pharma, Drug

Product for Phase I and non-pivotal Phase IIa human clinical trials.  The production and supply of Drug Substance

for non-clinical use is governed by the License Agreement.

 

3.             SUPPLY AND SPECIFICATIONS

 

3.1           Supply.

ImmunoGen is

obliged to supply BI Pharma with certain quantities of Drug Product in order

for BI Pharma to conduct Phase I Trials and non-pivotal Phase IIa Trials. The [   *   ] of [   *   ] to

be [   *   ] to

[   *   ] by

[   *   ] in

each respective [   *   ]

during the [   *   ]

of this [   *   ]

is attached hereto as Schedule [   *   ]. It is the

understanding of ImmunoGen and BI Pharma that ImmunoGen shall not be obliged to

supply BI Pharma with quantities [   *   ]

of the [   *   ]

of [   *   ]

in each [   *   ]

as listed in Schedule [   *   ]

attached to this Agreement, provided that ImmunoGen [   *   ] to [   *   ].  ImmunoGen shall produce

Drug Product in a series of Batch Runs, the exact number and size of which

shall be determined by [   *   ].  The Parties acknowledge that

the number, size and/or yield of Batch Runs are subject to change due to

numerous factors, including but not limited to production and purification

processes, recruitment of patients to clinical trials and the number of and

dosing schedules chosen for human clinical trials.

 

 

G-4

 

3.2           Drug

Substance and Drug Product Specifications. Draft

Specifications for Drug Substance and Drug Product as provided by BI Pharma are

attached hereto as Schedule A. The Parties acknowledge that these Draft

Specifications are subject to change with the collection of Batch Run

manufacturing data. Final Specifications have to be defined mutually by the

Parties prior to manufacture of the first clinical batch. ImmunoGen shall not make any changes

to the Final Specifications and the Master Batch Records, without the prior

written permission of BI Pharma; [   *   ]

that [   *   ]

has [   *   ]

, [   *   ]

be [   *   ]

for the [   *   ]

of such [   *   ]

and for [   *   ]

for [   *   ] or

[   *   ] arising

therefrom. 

Upon the determination of the Final Specifications, the Draft

Specifications will no longer be applicable to the manufacture of Drug

Substance and Drug Product and shall be replaced in full by the terms of the

Final Specifications.

 

3.3           Manufacturing

Process and Master Batch Records. ImmunoGen will

provide BI Pharma with Master Batch Records describing the Manufacturing

Process for Drug Product as well as for Drug Substance. ImmunoGen shall supply

BI Pharma with all required written information, including but not limited to

standard operating procedures, describing quality control procedures for

testing of Drug Substance and Drug Product. 

The Master Batch Records will be agreed upon by the Parties prior to

manufacturing of the first cGMP batch. Any change to the Master Batch Records

requires prior written approval by BI Pharma. ImmunoGen will provide copies of

all Manufacturing Documentation to BI Pharma.

 

3.4           Provision of BIWA4. BI Pharma shall

deliver the necessary quantities of BIWA4, at BI Pharma’s sole cost, for a

Batch Run no less than [   *   ] days prior to the scheduled initiation of the Batch Run. The Parties

acknowledge that the necessary quantity of BIWA4 is subject to change and is

dependent on the number, size and/or yield of Batch Runs. ImmunoGen shall not

be responsible for any delay caused by BI Pharma’s failure to deliver such

BIWA4 as contemplated by this Section 3.4. BI Pharma shall

provide or arrange to provide ImmunoGen free of charge with such quantities of

BIWA4 as shall be necessary according to the Master Batch Records for the

manufacture of Drug Product for BI Pharma. ImmunoGen shall

use the BIWA4 exclusively for the manufacturing of Drug Product for BI Pharma.

ImmunoGen shall store BIWA4 in controlled areas and in accordance with the

conditions specified by BI Pharma.  ImmunoGen shall issue a

written request for BIWA4 to BI Pharma (a “Shipment Order”) including, but not

limited to, amount and delivery date not later than [   *   ] prior to the scheduled initiation of the Batch Run.

 

3.5           Excipients and Other Components.

ImmunoGen shall purchase at [   *   ] all

excipients (pharmacopoeial grade), and other items of any nature whatsoever

that ImmunoGen may use or have used in manufacturing the Drug Product, other

than BIWA4. [   *   ]

the [   *   ]

for ensuring that all [   *   ]

used in the manufacture of Drug Product, comply with the Draft

Specifications and Final Specifications and all applicable laws and

regulations. ImmunoGen shall test and release all materials for identity and quality in

accordance with the Draft Specifications and Final Specifications prior to

using the same. All right, title and interest in and to

such items, and in and to all work-in-process incorporating such items, shall

remain the sole property of ImmunoGen.

 

 

G-5

 

3.6           [   *   ] has [   *   ]

into [   *   ]

for the [   *   ]

of [   *   ]

and [   *   ]

(“[   *   ]

”) and [   *   ]

, to [   *   ]

of its [   *   ]

, that the [   *   ] of [   *   ] and [   *   ]

under the [   *   ] , as in

effect on the Effective Date, is [   *   ]

to [   *   ]

for [   *   ] under Section [   *   ]

of the Supply Agreement.  A list of the [   *   ] is attached hereto as Schedule [   *   ].

 

4.             FORECASTS

AND PURCHASE ORDERS

 

4.1           Initial

Supply Forecast. The minimum quantities of clinical Drug Product

to be supplied to BI Pharma by ImmunoGen during the Term of this Agreement is

attached as an initial non-binding forecast for Drug Product in Schedule

[   *   ]

(provision of clinical Drug Product). In Schedule[   *   ]

the [   *   ] of [   *   ] that [   *   ] to [   *   ] from [   *   ] based upon [   *   ] is listed beginning with the first Calendar Year after the Effective

Date.

 

4.2           Drug Product Forecasts. BI Pharma shall

use its best efforts to submit to ImmunoGen within thirty (30) days of the

Effective Date and thereafter at least three (3) calendar months prior to the

start of each Calendar Quarter, a rolling written forecast of the quantities of

Drug Product estimated to be required for the following four Calendar Quarters

(“Drug Product Forecast”). In the Drug Product Forecast, BI Pharma shall

include a breakdown of the total quantity of Drug Product by Calendar Quarters.

The Parties acknowledge that factors including, but not limited to, number of

human clinical studies conducted, clinical study enrollment and stability of

Drug Product might affect the accuracy of such Drug Product Forecasts. [   *   ] will [   *   ]

from time to time the [   *   ] so as to [   *   ]

for such [   *   ].

 

4.3           Delivery of Purchase Order; Contents.

Together with each Drug Product Forecast, BI Pharma shall deliver to ImmunoGen,

in writing, a binding purchase order (“Purchase Order”) for Drug Product for

the [   *   ]

Subsequent Purchase Orders shall equal the Drug

Product Forecast for the [   *   ]

of the accompanying forecast. Each Purchase Order

shall specify: (i) the total quantity of Drug Product; (ii) a reference to the

actual Final Specification and the Master Batch Records; (iii) the requested

location for delivery; (iv) time of delivery; and (v) the carrier and/or manner

of shipment that ImmunoGen should use in delivering the Drug Product.

 

4.4           Governing

Terms. For ordering, the [   *   ]

shall use [   *   ] (see Schedule [   *   ]

[   *   ]:), however all

orders shall be subject to the provisions of this Agreement and shall not be

subject to any inconsistent terms and conditions contained on any Purchase

Order or Shipment Order, except insofar as any such document or request

establishes: (a) the quantity of Drug Product to be shipped; (b) the delivery

date; (c) the requested location for delivery; or (d) the carrier and/or manner

of shipment.

 

4.5           [   *   ] for

[   *   ]

to [   *   ].  In the event that, over a

given [   *   ], [   *   ]

to [   *   ]

with at [   *   ]

of the [   *   ] of [   *   ]

specified in the [   *   ] for that

[   *   ]

or the [   *   ]

of [   *   ]

specified in Schedule [   *   ] for that [   *   ]

and [   *   ]

is not [   *   ]

to a [   *   ]

set forth in Section [   *   ] or to a [   *   ]

by [   *   ]

or [   *   ]

of this Agreement, then, subject to the [   *   ] of [   *   ]

Section [   *   ]

under the [   *   ] as

follows.  If [   *   ] to [   *   ]

of [   *   ], then [   *   ]

the [   *   ]

and [   *   ]

pursuant to Section [   *   ] of the [   *   ].  If [   *   ] to [   *   ]

of [   *   ], then [   *   ]

the [   *   ] and [   *   ]

pursuant to Section [   *   ] of the[   *   ].  The foregoing

notwithstanding, [   *   ]

the [   *   ]

of the [   *   ]

to [   *   ]

such [   *   ]

and [   *   ].

 

 

 

G-6

 

4.6           Notices. 

All notices to ImmunoGen under this Section 4 shall be delivered to

ImmunoGen to the attention of [   *   ]

at 128 Sidney Street, Cambridge, Massachusetts USA

02139 or to such other person and location as ImmunoGen may specify to BI

Pharma in writing from time to time.

 

5.             PRODUCTION

 

5.1           Batch Runs. All production and supply

by ImmunoGen of Drug Product under this Agreement shall be denominated in terms

of Batch Runs. ImmunoGen will review each Drug Product Forecast and determine [   *   ] the exact number and size of the Batch Runs necessary to fulfill each

Purchase Order. The Parties acknowledge that the number, size and/or yield of

Batch Runs are subject to change due to numerous factors, including but not

limited to production and purification processes. [   *   ] to [   *   ]

and [   *   ]

the [   *   ]

for[   *   ]

to [   *   ]

for [   *   ]

of [   *   ]

(for details, see [   *   ]

Section [   *   ]

).  The

Parties agree that all changes to the Manufacturing Process are subject to a

change control procedure and have to be finally agreed upon by BI Pharma.

ImmunoGen shall complete in accordance with the requirements of cGMP a

Manufacturing Documentation and a Certificate of Analysis for every Drug

Substance Batch and Drug Product Batch. ImmunoGen shall provide copies of this

documentation and shall maintain all documentation pertaining to the Drug

Product for at least [   *   ]

of the date of final release by BI Pharma of the Drug

Product.

 

5.2           Specifications.

All Drug Product supplied to BI Pharma hereunder (i) will comply with all

applicable Draft Specifications or Final Specifications at the time of

manufacture and (ii) will have been manufactured in accordance with the Master

Batch Records and cGMP.

 

5.3           Facility. ImmunoGen shall conduct all

manufacturing of the Drug Substance at the Facility and shall maintain at the

Facility all equipment, Dedicated Equipment, components and other items used to

manufacture Drug Substance. ImmunoGen (i) shall notify BI Pharma in writing,

not less than [   *   ]

prior to any proposed, foreseeable change in the

location or status of the Facility and (ii) shall notify BI Pharma in writing

as soon as possible of any unforeseeable change in the location or status of

the Facility and (iii) shall be responsible for obtaining, at its own expense,

any necessary regulatory approvals in connection with any such change and BI

Pharma’s agreement thereto. [   *   ]

to [   *   ]

with the [   *   ]

to [   *   ]

at the Facility. Any [   *   ] in the [   *   ]

of the [   *   ] , which shall not be unreasonably withheld.

 

5.4           [   *   ].

 Notwithstanding the following provision, [   *   ]

shall not be allowed to [   *   ]

any [   *   ]

in the [   *   ]

and [   *   ]

of the [   *   ]

the [   *   ]

of [   *   ]. The [   *   ] of [   *   ] is attached hereto as Schedule [   *   ].  [   *   ]

and [   *   ]

of [   *   ]

of [   *   ].  [   *   ]

(i) shall notify [   *   ]

in writing, not less than [   *   ]

prior to any [   *   ]

in the [   *   ]

and (ii) shall notify [   *   ]

in writing as soon as possible of any [   *   ]

in the [   *   ].  However, in the case of a [   *   ]

in [   *   ], [   *   ] of [   *   ] or [   *   ] of [   *   ] shall require the [   *   ] of [   *   ].  [   *   ]

hereby [   *   ]

that [   *   ]

has the [   *   ]

to [   *   ]

each of [   *   ], to be [   *   ], if feasible, and that the [   *   ]

is [   *   ]

to [   *   ] into a [   *   ].

 

 

G-7

 

5.5           Dedicated Equipment.

ImmunoGen shall supply, at its own expense, all equipment required for the

purpose of manufacturing the Drug Substance. Notwithstanding the foregoing, if

during the Term of this Agreement, [   *   ] determine

in [   *   ]

that it is necessary or advisable to purchase

Dedicated Equipment for ImmunoGen to perform any of its obligations to

manufacture Drug Substance under this Agreement, then ImmunoGen shall [   *   ] of [   *   ], along with the [   *   ]

for such [   *   ]

and [   *   ]

for such Dedicated Equipment, in order to achieve BI

Pharma’s written approval of the same. [   *   ] shall

evaluate [   *   ]

the [   *   ]

of such Dedicated Equipment to [   *   ] to be [   *   ]

for such [   *   ]

is [   *   ]

to [   *   ] and whether such [   *   ]

at a [   *   ].  [   *   ]shall provide [   *   ]

with a [   *   ]

of [   *   ]

to [   *   ]

of [   *   ], which will be necessary during the production of Drug Product (see Schedule

[   *   ]). Subject to the foregoing, promptly after the consummation of such

purchase on behalf of BI Pharma, ImmunoGen shall provide BI Pharma with a copy

of the invoice or invoices reflecting such purchase(s), and BI Pharma shall

reimburse ImmunoGen for the purchase of all such agreed Dedicated Equipment

hereunder within [   *   ]

of its receipt of such invoices from ImmunoGen. All

such Dedicated Equipment shall be owned by BI Pharma, shall be maintained,

decontaminated and cleaned by ImmunoGen as long as ImmunoGen has possession

thereof, and shall be used by ImmunoGen solely for the benefit of BI Pharma.

The Parties hereby agree that any costs that are incurred by ImmunoGen and are

reimbursed by BI Pharma under this Section 5.5 shall not be included within the

[   *   ]

of any [   *   ]

under this Agreement. Upon any termination of this

Agreement, ImmunoGen shall permit BI Pharma to remove all such Dedicated

Equipment from its Facility at BI Pharma’s sole cost and expense, provided,

that any reimbursement due by BI Pharma for such Dedicated Equipment has been

fully paid to ImmunoGen.

 

5.6           Maintenance

of Facility. ImmunoGen shall maintain, at its own expense, the

Facility, (including, without limitation the equipment and the Dedicated

Equipment) in a state of repair, cleanliness and operating efficiency

consistent with the requirements of the Draft Specifications and Final

Specifications respectively, cGMP and other applicable requirements.

 

6.             DELIVERY,

TESTING AND ACCEPTANCE

 

6.1           Pre-Delivery

Testing.

 

6.1.1.          ImmunoGen Responsibilities.

Prior to delivery to BI Pharma, ImmunoGen shall test, or cause to be tested, a

representative sample of each Drug Product Batch (or components as applicable)

to demonstrate that such Drug Product Batch complies with the applicable

specifications (manufacturer’s release). For each Drug Product Batch to be

delivered to BI Pharma or to a recipient designated by BI Pharma, ImmunoGen

shall prepare and submit a representative sample of such Drug Product Batch,

and a Certificate of Analysis that identifies the items tested, the applicable

specifications and test results. The present format and required content of the

Certificate of Analysis is attached hereto as Schedule I. Any

changes thereto shall be agreed upon by the Parties. ImmunoGen will also submit

a copy of the Manufacturing Documentation. ImmunoGen shall provide raw data

upon reasonable request by BI Pharma.

 

 

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6.1.2.          BI Pharma Responsibilities.

Prior to delivery to BI Pharma, BI Pharma shall determine whether the Drug

Product conforms to applicable specifications for use in human clinical trials

(the “Review”). BI Pharma may conduct a Review by: (i) reviewing the

Certificate of Analysis and the Manufacturing Documentation and such other

documents, if any, as BI Pharma may request; and (ii) conducting acceptance

testing of a representative sample of the Drug Product Batch. BI Pharma shall conduct

its Review within [   *   ]

of the receipt of a representative sample of the Drug

Product Batch including Manufacturing Documentation of Drug Substance, [   *   ] that [   *   ]

have a [   *   ]

of [   *   ]

for [   *   ]

after [   *   ]

of [   *   ]

and [   *   ]

after [   *   ]

of [   *   ]

the [   *   ].

 

6.1.3.          Specification Dispute Resolution.

In case of any disagreement between the Parties as to whether a Drug Product

conformed with applicable Draft Specifications or Final Specifications, a representative

sample of the disputed Drug Product shall be submitted for tests and final

determination of whether the Drug Product conformed with such applicable

specifications to an independent testing organization mutually agreed upon by

the Parties (the “Laboratory”).  The

Laboratory must meet current Good Laboratory Practices as defined by the FDA

from time to time, and the appointment of such Laboratory shall not be

unreasonably withheld or delayed by either Party. Such Laboratory shall use the

test methods contained in the applicable specifications. The determination of

such Laboratory with respect to all or part of the Drug Product shall be final

and binding on the Parties.  The fees

and expenses of the Laboratory incurred in making such determination shall be

paid by the Party against whom the determination is made.

 

6.2           Notification. Within [   *   ] of the completion of the Review, BI Pharma shall notify ImmunoGen in

writing whether the Drug Product conforms to Final Specifications.

 

6.3           [   *   ];

Inspection and Rejection; Shortages. In the event

that any Drug Product Batch after [   *   ]

to BI Pharma is [   *   ]

to [   *   ]

to [   *   ]

with the [   *   ], ImmunoGen shall, [   *   ] (a) [   *   ] of such Drug Product to BI Pharma or [   *   ]

the [   *   ], as the case may be, [   *   ]; or (b) if [   *   ] is not possible [   *   ], at [   *   ], either [   *   ] or [   *   ] for the [   *   ] for such Drug Product. ImmunoGen may [   *   ]

any Drug Product [   *   ]

for [   *   ].  The foregoing does not apply

if the [   *   ] of the [   *   ] is [   *   ] the [   *   ] of ImmunoGen.  [   *   ], the [   *   ] only if [   *   ] is [   *   ] to the [   *   ] of the [   *   ].  [   *   ]

shall [   *   ]

the [   *   ]

and [   *   ]

for the [   *   ]

of [   *   ]

to [   *   ]

as the [   *   ]

over [   *   ]

from [   *   ]

with the [   *   ].  Any dispute regarding [   *   ]

under [   *   ]

Section [   *   ]

shall be resolved in the same manner as provided for

in Section [   *   ]

 

6.4           Failed Batches. ImmunoGen shall bear

the responsibility for a failed Batch Run if such failure is attributable to

the [   *   ]

or [   *   ]

of ImmunoGen. 

The foregoing notwithstanding, the [   *   ] that

there may be [   *   ]

not [   *   ]

to [   *   ]

. [   *   ]

of [   *   ]

shall take place according to the [   *   ] in [   *   ], in which the [   *   ]

to the [   *   ]

of [   *   ].

 

6.5           Shipment.

Upon receipt of written notice from BI Pharma, ImmunoGen shall deliver to BI

Pharma or as directed by BI Pharma the respective Drug Product on the date

provided for in the respective Purchase Order. 

Drug Product delivered pursuant to the terms of this Agreement shall be

suitably packed and marked for shipment according to BI Pharma’s Purchase

Order. Delivery terms shall be DDP location in EU as determined by BI Pharma in

the respective Purchase Order or CIP Ridgefield (INCO terms 2000) at BI

Pharma’s option. [   *   ] to the[   *   ] be [   *   ] to [   *   ] upon [   *   ] of [   *   ].  The Parties shall agree on a

preferred carrier, packaging material, and detailed insurance conditions.  

 

 

G-9

 

6.6           Final

Release. BI Pharma shall be responsible for the release of Drug

Product for use in clinical trials (final release).

 

6.7           Notices.  All notices to ImmunoGen under this Section

6 shall be delivered to ImmunoGen to the attention of [   *   ]

at 333 Providence Highway, Norwood, Massachusetts USA

02062 or to such other person and location as ImmunoGen may specify to BI

Pharma in writing from time to time.

 

6.8           [   *   ].  In an effort to [   *   ] the [   *   ]

of [   *   ]

the [   *   ]

of [   *   ]

by the [   *   ]

of [   *   ]

, [   *   ]

and [   *   ]

hereby agree to use [   *   ] during the [   *   ]

of this [   *   ]

to [   *   ]

and [   *   ]

an [   *   ]

of [   *   ]

of the [   *   ]

to [   *   ]

the [   *   ]

listed on Schedule [   *   ] of the[   *   ], as it becomes [   *   ]

and to the extent it is [   *   ] or [   *   ]

and [   *   ]

and [   *   ].  In connection therewith,

ImmunoGen shall provide [   *   ]

to BI of the [   *   ] of [   *   ] and the [   *   ]

as well as the other [   *   ] (if any) of such [   *   ]

and [   *   ]

to [   *   ]

to [   *   ]

.  Subject to

the foregoing, all [   *   ]

associated with [   *   ] the [   *   ] of [   *   ]

shall be borne by [   *   ]. 

Upon any termination of this Agreement, [   *   ]

shall [   *   ] to [   *   ] all such [   *   ] from its [   *   ] at sole cost and expense, provided, that any [   *   ]

due by [   *   ]

[   *   ] for such [   *   ]

has been fully paid to [   *   ].

 

7.             PRICE

AND PAYMENT

 

7.1           Transfer Price for Product. All Drug

Product supplied to BI Pharma or a third party designated by BI Pharma under

this Agreement shall be supplied to BI Pharma at a Transfer Price equal to [   *   ] of ImmunoGen’s [   *   ]

of such [   *   ]

in accordance with Section [   *   ] hereof.

 

7.2           Invoicing and Timing. The payment will

be made [   *   ]

upon written notice of [   *   ] of the [   *   ]

by [   *   ]

and after [   *   ] by [   *   ] of the [   *   ], [   *   ]

if any.  The [   *   ] or [   *   ] shall [   *   ]

the [   *   ]

of [   *   ]

as described in Schedule [   *   ] . In case of [   *   ]

that [   *   ]

is [   *   ]

to [   *   ]

for pursuant to Schedule [   *   ], [   *   ]

shall be made within [   *   ] of receipt of such invoice.  Any invoices which remain unpaid more than [   *   ] beyond the scheduled payment due date may

be subjected to an interest charge at a rate of [   *   ].

 

7.3           Notices.  All notices to BI Pharma under this Section

7 shall be delivered to BI Pharma to the attention of Grp.Contr.F+E+M Pharma D,

att.: [   *   ] at Birkendorfer Str. 65, 88397 Biberach, Germany, or to such other

person and location as BI Pharma may specify to ImmunoGen in writing from time

to time.

 

 

G-10

 

8.             TITLE AND AUDIT RIGHTS

 

8.1           BI Pharma

Audit Rights.

 

8.1.1.          Audit of Facility. ImmunoGen

agrees that BI Pharma and its agents shall have the right, upon reasonable

prior notice to ImmunoGen, to inspect the Facility and audit ImmunoGen’s

quality control system and [   *   ]

during normal business hours in order to ascertain

compliance by ImmunoGen with the terms of this Agreement, including, but not

limited to, inspection of (a) the materials used in the manufacture of the Drug

Product, (b) the holding facilities for such materials, (c) the equipment used

to manufacture the Drug Product, (d) the quality control procedures and (e) all

records relating to such manufacturing, quality control and Facility. Any

information disclosed in writing, orally or by inspection of tangible objects

shall be considered ImmunoGen’s Confidential Information and protected as such

by BI Pharma and its agents pursuant to the terms of the License Agreement. [   *   ] agrees to [   *   ]

and [   *   ]

of [   *   ]

of [   *   ]

and [   *   ]

a [   *   ]

to the [   *   ].

 

8.1.2.          [   *   ]

of [   *   ].  [   *   ]

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

 

8.1.3.          Audit of Total Cost. ImmunoGen

shall keep complete and accurate records of its Total Cost of Drug Product

supplied under this Agreement in sufficient detail to allow such Total Cost to

be determined accurately. BI Pharma shall have the right, during the Term of

this Agreement [   *   ], to appoint an independent certified public accountant reasonably

acceptable to ImmunoGen to inspect the relevant records of ImmunoGen to verify

its statements of Total Cost of Drug Product. ImmunoGen shall make its records

available for inspection by such independent certified public accountant during

regular business hours at such place or places where such records are

customarily kept, upon reasonable notice from BI Pharma, solely to verify the accuracy

of its statements of Total Cost of Drug Product. Such inspection right shall

not be exercised more than [   *   ] during any [   *   ] period.  BI Pharma agrees to

hold in strict confidence all information concerning ImmunoGen’s costs, and all

information learned in the course of any audit or inspection, except to the

extent necessary for BI Pharma to reveal such information in order to enforce

its rights under this Agreement or if disclosure is required by law, regulation

or judicial order. The results of each inspection, if any, shall be binding on

both Parties. BI Pharma shall pay for such inspections, except that, in the

event an inspection reveals an overcharge to BI Pharma of greater than [   *   ], ImmunoGen shall pay for such inspection.

 

8.2           Government

Inspections. ImmunoGen, in accordance with applicable laws and

regulations, shall permit representatives of any regulatory agency having

jurisdiction over the manufacture and/or marketing of the Drug Substance or the

Drug Product, including the FDA and the EMEA, but not limited to the same, to

inspect its Facility in conjunction with the manufacture, quality control,

registration, storage, handling and shipping of the Drug Product. ImmunoGen

shall promptly advise BI Pharma if ImmunoGen receives a notice of an impending

inspection or if an authorized agent of the FDA or other governmental agency

visits any of ImmunoGen’s facilities including the Facility concerning the Drug

Product. ImmunoGen shall furnish to BI Pharma non-confidential copies of any

report, including any FDA Form 483 notices (or comparable notices of other

agencies), regulatory letters or similar documents received from such agency

and the application of such report to Drug Product, if any, within [   *   ]

of ImmunoGen’s receipt of such report.

 

 

G-11

 

9.             TERM AND TERMINATION

 

9.1           Term. This Agreement shall become

effective on the Effective Date and shall continue in full force and effect

until the earlier of the conclusion of Phase I Trials and non-pivotal Phase IIa

Trials or the termination of the License Agreement (the “Term”).

 

9.2           Termination

[   *   ].  This Agreement may

be terminated [   *   ] by [   *   ] by giving [   *   ] prior written notice to[   *   ].

 

9.3           Early

Termination.Notwithstanding Section 9.1, either Party may,

in addition to exercising any other available legal or equitable rights or

remedies, terminate this Agreement, effective immediately upon the expiration

of any applicable cure period, upon the occurrence of an Event of Default (as

defined below) with respect to the other Party.  The term “Event of Default” with respect to a Party means the

occurrence of any of the following events:

 

(a)                                  The failure of a Party to comply with or

perform any material provision of this Agreement, and such failure remains

uncured for [   *   ]

following written notice of such failure (if such default is cured

within the cure period, such written notice shall be null and void), provided

that, if the defaulting Party can establish to the reasonable satisfaction of

the other Party that it is diligently and actively pursuing a cure at the

expiration of the cure period, and that the default is reasonably capable of

being cured, then the cure period shall be extended for so long as a cure is

being diligently and actively pursued, not to exceed [   *   ] in the aggregate.

 

(b)                                 A Party (i) becomes unable to pay

its debts as they mature, (ii) is the subject of a voluntary or involuntary

petition in bankruptcy or of any other proceeding under bankruptcy, insolvency

or similar laws which, if involuntary, is not dismissed within [   *   ] of

the date filed, (iii) makes an assignment for the benefit of creditors, (iv) is

named in, or its property is subject to, a suit for the appointment of a

receiver which is not dismissed within [   *   ]

of the date filed, or (v) is dissolved or liquidated.

 

9.4           Effect of

Termination of this Agreement. The termination of this Agreement

shall in no way affect the validity of the License Agreement.  Upon termination, ImmunoGen shall invoice BI

Pharma for all costs that are incurred but remain unbilled as of the effective

date of termination.  Payment of such

invoice shall be pursuant to the terms of Section 7.2 of this Agreement.

 

9.5           Limited

Liability.  Except as

otherwise provided in this Agreement, neither ImmunoGen nor BI Pharma will be

liable with respect to any subject matter of this Agreement under any contract,

negligence, strict liability or other legal or equitable theory for any

punitive damages or indirect, incidental, consequential damages or lost

profits, including, without limitation, cost of procurement of substitute goods

or technology, or loss of opportunity, loss of income or compensation for loss

of goodwill.

 

 

G-12

 

10.          SECRECY OBLIGATIONS

 

10.1         General

Applicability of the Provisions of the License Agreement. The

Parties are in agreement that the confidentiality and secrecy obligations of

the License Agreement shall apply to this Agreement for the Term of this

Agreement and for a period of [   *   ]

thereafter.

 

11.          ADDITIONAL OBLIGATIONS OF THE PARTIES

 

11.1         Laws and

Regulations. The Parties agree to comply with all applicable

laws, rules, regulations or requirements in connection with the manufacture of

BIWA4, Drug Substance, and Drug Product.

 

11.2         Permits

and Licenses for Facility / Regulatory Submissions. ImmunoGen

shall be responsible for obtaining, [   *   ], any Facility or other licenses or permits, and any regulatory and

government approvals necessary for the manufacture of Drug Substance and the

supply of Drug Product to BI Pharma in accordance with the terms and conditions

of this Agreement. ImmunoGen shall provide to BI Pharma all information

relevant to specific methods of Drug Product manufacture and any other

information specific to the Drug Product and relevant to FDA and analogous

non-U.S. regulatory submissions, including, without limitation, IND, BLA and

other regulatory submissions, in a timely manner to enable punctual submission

by BI Pharma of necessary regulatory documentation.

 

11.3         Notification of Inspections; Communications.

ImmunoGen shall permit BI Pharma or its agents to be present and participate in

any visit to, or inspection of, the Facility as it pertains to Drug Substance

or Drug Product or review of the Manufacturing Process by any Competent

Authorities. ImmunoGen shall give prompt notice to BI Pharma of any such visit,

inspection or review. ImmunoGen shall promptly provide to BI Pharma all

information (including copies of any written communication) from and to

Competent Authorities concerning the Drug Substance or Drug Product, and shall

use reasonable commercial efforts to consult with BI Pharma concerning the

response of ImmunoGen to each such communication. It is understood by the Parties that all such communications fall

under the confidentiality obligations.

 

11.4         Regulatory

Assistance. ImmunoGen agrees to provide to BI Pharma such

information and assistance relating to the manufacture and quality control of

the Drug Product as BI Pharma may reasonably require for purposes of applying

for and maintaining all registrations for the Drug Product including, without

limitation, providing BI Pharma with all reports, authorizations, certificates,

methodologies, and other documentation in the possession or under the control

of ImmunoGen relating to the manufacture and quality control of the Drug

Product (or any component thereof).

 

 

G-13

 

11.5         Debarment.

ImmunoGen represents and warrants that it has not been debarred and is not

subject to a pending debarment and that it will not use in any capacity, in

connection with the services to be performed under this Agreement, any person

who has been debarred pursuant to section 306 of the Federal Food, Drug, and

Cosmetic Act, 21 U.S.C. § 335a, or who is the subject of a conviction

described in such section. ImmunoGen agrees to inform BI Pharma in writing

immediately if it or any person who is performing services hereunder is debarred

or is the subject of a conviction described in section 306, or if any action,

suit, claim, investigation, or legal or administrative proceeding is pending

or, to the best of ImmunoGen’s knowledge, is threatened, relating to the

debarment or conviction of ImmunoGen or any person performing services

hereunder.

 

11.6         Compliance

with U.S. Export Regulations. BI Pharma understands that Drug

Product to be purchased hereunder may require ImmunoGen to obtain a validated

export license from the United States Department of Commerce. It shall be

ImmunoGen’s task and responsibility to obtain such export license and BI Pharma

agrees to assist ImmunoGen in obtaining any such required license by supplying

appropriate documentation reasonably requested by ImmunoGen. In connection

therewith, BI Pharma agrees to comply with U.S. Export Administration

Regulations as in effect from time to time and brought to BI Pharma’s attention

by ImmunoGen. BI Pharma will also maintain all records necessary to comply with

United States Export Administration Regulations brought to BI Pharma’s

attention by ImmunoGen.

 

12.          WARRANTY /LIABILITY

 

12.1.1.     ImmunoGen Representations:  ImmunoGen represents and warrants to BI

Pharma that:

 

(a)                                  No Conflict. The execution, delivery and performance of

this Agreement by ImmunoGen does not conflict with any agreement, instrument or

understanding, oral or written, to which it is a Party or by which it may be

bound, and does not violate any law or regulation of any court, governmental

body or administrative or other agency having authority over it.  ImmunoGen is not currently a party to, and

during the term of this Agreement will not enter into, any agreements, oral or

written, that are inconsistent with its obligations under this Agreement.

 

(b)                                 Authority. ImmunoGen is validly existing and in good

standing under the laws of the state of its incorporation and has the corporate

power and authority to enter into this Agreement. The execution, delivery and

performance of this Agreement have been duly authorized by all necessary action

on the part of ImmunoGen, its officers and directors.

 

 

G-14

 

(c)                                  Ownership.  To

ImmunoGen’s knowledge, all of the Licensed Patents are subsisting and are valid

and enforceable. ImmunoGen (i) has not previously assigned, transferred,

conveyed or otherwise encumbered its right, title and interest in Licensed

Patents, or any component of the Licensed Technology, and (ii) has no

knowledge of the existence of any patent, trademark or other intellectual

property right (other than any patent application) owned or Controlled by

ImmunoGen, other than the Licensed Patent Rights, in case of either (i) or

(ii), that would prevent ImmunoGen and BI Pharma from manufacturing and

supplying Drug Product, and BI from exploiting its rights granted under Section

2.1 of the License Agreement.  In

addition, ImmunoGen has no knowledge of the existence of any patent or

intellectual property right (other than any patent application) owned or

Controlled by a third party that would materially conflict with the grant of

the license set forth in Section 2.1 of the License Agreement.

 

(d)                                 Litigation. There are no claims, judgements or settlements

against, pending with respect to the Licensed Patents or any component of

Licensed Technology. In addition, to ImmunoGen’s knowledge, no such claims,

judgements or settlements are threatened.

 

(e)                                  Further Warranties: 

ImmunoGen covenants to BI Pharma that:

 

(i)                                     The development and manufacture of Drug

Substance and Drug Product by ImmunoGen under this Agreement shall be in

compliance with all applicable laws, requirements and regulations.

 

(ii)                                  All Certificates of Analysis which will be

provided to BI Pharma under this Agreement shall be generated and documented in

accordance with generally accepted standards of the pharmaceutical industry.

 

(iii)                               ImmunoGen hereby represents and warrants that

as of the Effective Date (a) ImmunoGen has [   *   ]

the [   *   ]

as listed on Schedule [   *   ],

and (b) each of the is in [   *   ]

and [   *   ]

and constitutes a [   *   ]

and [   *   ]

of [   *   ].

 

12.1.2.     BI Pharma Representations and

Warranties:  BI Pharma represents,

warrants and covenants to ImmunoGen that:

 

(a)                                  No Conflict. The execution, delivery and performance of

this Agreement by BI Pharma does not conflict with any agreement, instrument or

understanding, oral or written, to which it is a party or by which it may be

bound, and does not violate any law or regulation of any court, governmental

body or administrative or other agency having authority over it.  BI Pharma is not currently a party to, and

during the term of this Agreement will not enter into, any agreements, oral or

written, that are inconsistent with its obligations under this Agreement.

 

 

G-15

 

(b)                                 Authority. BI Pharma is validly existing and in good

standing under the laws of the state of its incorporation and has the corporate

power and authority to enter into this Agreement. The execution, delivery and

performance of this Agreement have been duly authorized by all necessary action

on the part of BI Pharma, its officers and directors.

 

(c)                                  BIWA4.  BI

Pharma’s manufacture and delivery of BIWA4 under this Agreement shall be in

compliance with the laws, requirements and regulations applicable thereto in

the Territory.

 

12.1.3.     Indemnification

by the Parties: Each party (the “Indemnitor”) will indemnify the other

party (the “Indemnitee”) against any liability in connection with any claim,

suits, liabilities, etc. arising out of the performance by the Indemnitor of

its work under this Agreement or the exploitation by the Indemnitor of its

rights under this Agreement, including, without limitation, the development and

manufacture of Drug Substance and Drug Product, unless such liability results

from (i) the negligence or wilful misconduct of the Indemnitee or (ii) a breach

of the warranties set forth in this Agreement by the Indemnitee.

 

12.1.4.     Indemnification Procedures:

 

(a)                                  The Indemnitee shall: (i) notify the Indemnitor

of any liability and full details of the basis therefor with respect to which

the Indemnitee intends to claim indemnification as soon as practicable after

the Indemnitee becomes aware of any such liability; (ii) permit the Indemnitor

to assume the defence thereof ; and (iii) cooperate with the Indemnitor, at the

Indemnitor’s expense, in the defence thereof.

 

(b)                                 With respect to any matter for which the

Indemnitor has an obligation to indemnify the Indemnitee under this Agreement,

the Indemnitee shall have the right to participate and be represented (at the

Indemnitor’s expense) by legal counsel of the Indemnitee’s choice in all

proceedings and negotiations, if representation by counsel retained by

Indemnitor would be inappropriate due to actual or potential differing

interests between the Indemnitee and any other party represented by such

counsel in such proceedings.

 

(c)                                  The indemnity agreement in this Section 12

shall not apply to amounts paid in settlement of any liability if such

settlement is effected without the consent of the Indemnitor, which consent

shall not be unreasonably withheld.

 

(d)                                 Failure of the Indemnitee to deliver notice to

the Indemnitor within [   *   ]

after becoming aware of a liability shall relieve the Indemnitor of

any liability to the Indemnitee pursuant to this Section 12 in the event, but

only to the extent, such delay is prejudicial to the Indemnitor’s ability to

defend such action.

 

 

G-16

 

13.          MISCELLANEOUS

 

13.1         Force Majeure. The Parties shall not be

liable in any respect for failure to perform their obligations hereunder or for

delay in shipment of BIWA4 or Drug Product pursuant to accepted orders where

such failure or delay shall have been due wholly or in part to the elements,

acts of God, acts of civil or military authority or terrorism, fires, floods,

epidemics, quarantine restrictions, war, riots, strikes, lock outs, break down,

differences with workmen, accidents to machinery, delays in transportation or

delays in delivery by suppliers or manufacturers beyond the Parties’ control.

In event of such force majeure, the Party affected thereby shall use reasonable

efforts to cure or overcome the same and resume performance of its obligations

hereunder.

 

13.2         Other

Restrictions. Both Parties will conduct business in a manner

that reflects favorably at all times on the products containing DM1, goodwill,

and reputation of the other Party. Without limiting the foregoing, neither

Party nor its Affiliates shall engage in any deceptive, misleading, illegal,

unfair, or unethical practices that are or may be detrimental to the other

Party or its Affiliates.

 

13.3         Notices.

Unless otherwise and expressly required under this Agreement, all notices shall

be in writing and mailed via certified mail, return receipt requested, courier,

or facsimile transmission addressed as follows, or to such other address as may

be designated by either Party in writing to the other Party from time to time:

 

	

  If to ImmunoGen:

   

  	

   

  	

  If to BI Pharma:

  
	

  Attn: Chief Executive Officer

  	

   

  	

  Attn: 

  Clinical Trial Supplies Unit

  
	

  128 Sidney Street

  	

   

  	

  Department of Pharmaceutical Research and

  Development

  
	

  Cambridge, MA 02139

  	

   

  	

  Birkendorfer Strasse 65

  
	

  United States of America

  	

   

  	

  88397 Biberach

  
	

   

  	

   

  	

  Germany

  

 

13.4         Governing

Law. This Agreement shall be governed [   *   ].  Where not as otherwise provided for in this

Agreement, in the event of any controversy or claim arising out of or relating

to any provision of this Agreement, the Parties shall first try to settle those

conflicts amicably between themselves. Any dispute, controversy or claim

initiated by either Party arising out of, resulting from or relating to this

Agreement, or the performance by either Party of its obligations under this

Agreement (other than bona fide third Party actions or proceedings filed or

instituted in an action or proceeding by a third Party against a Party),

whether before or after termination of this Agreement, shall be finally

resolved by binding arbitration. 

Whenever a Party shall decide to institute arbitration proceedings, it

shall give written notice to that effect to the other Party.  Any such arbitration shall be conducted

under the commercial arbitration rules of the ICC by a panel of three

arbitrators appointed in accordance with such rules.  Any such arbitration shall be held in [   *   ].  The arbitrators shall have the authority to

grant specific performance and to allocate between the Parties the costs of

arbitration in such equitable manner as they determine.  Judgment upon the award so rendered may be

entered in any court having jurisdiction or application may be made to such

court for judicial acceptance of any award and an order of enforcement, as the

case may be.  In no event shall a demand

for arbitration be made after the date when institution of a legal or equitable

proceeding based upon such claim, dispute or other matter in question would be

barred by the applicable statute of limitations.  Notwithstanding the foregoing, either Party shall have the right,

without waiving any right or remedy available to such Party under this

Agreement or otherwise to seek and obtain from any court of jurisdiction any

interim or provisional relief that is necessary or desirable to protect the

rights or property of such Party, pending the selection of the arbitrators

hereunder or pending the arbitrators’ determination of any dispute, controversy

or claim hereunder.

 

 

G-17

 

13.5         Binding

Effect. This Agreement shall be binding upon and inure to the

benefit of the Parties and their respective legal representatives, successors

and permitted assigns.

 

13.6         Headings.

Section and subsection headings are inserted for convenience of reference only

and do not form a part of this Agreement.

 

13.7         Amendment;

Waiver. This Agreement may be amended, modified, superseded or

canceled, and any of the terms may be waived, only by a written instrument

executed by each Party or, in the case of waiver, by the Party or Parties

waiving compliance. The delay or failure of any Party at any time or times to

require performance of any provisions shall in no manner affect the rights at a

later time to enforce the same. No waiver by any Party of any condition or of

the breach of any term contained in this Agreement, whether by conduct, or

otherwise, in any one or more instances, shall be deemed to be, or considered

as, a further or continuing waiver of any such condition or of the breach of

such term or any other term of this Agreement.

 

13.8         Independent

Contractors; No Agency or Partnership. The relationship between

ImmunoGen and BI Pharma is that of independent contractors. Nothing contained

in this Agreement shall give either Party the right to bind the other, or be

deemed to constitute the Parties as agents for the other or as partners with each

other or any third party.

 

13.9         Assignment

and Successors. Either Party shall not be entitled to assign or otherwise transfer its

rights and obligations under this Agreement in whole or in part to any third

party without the prior written consent of the other Party.

 

13.10       Integration;

Severability. If any provision of this Agreement is or becomes

invalid or is ruled invalid by any court of competent jurisdiction or is deemed

unenforceable, it is the intention of the Parties that the remainder of the

Agreement shall not be affected.

 

14.          LIST OF SCHEDULES

 

Schedule A:                               [   *   ]

for Drug Substance

and Drug Product as provided by BI Pharma

 

Schedule B:                                 [   *   ]

Dedicated Equipment to [   *   ]

of [   *   ], which will be necessary during the production of Drug Product (see

Section 5.5)

 

 

G-18

 

Schedule [   *   ]:        Table of [   *   ]

 

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

 

Schedule [   *   ]:        [   *   ]

 

Schedule F:                                  Purchase Order BI Pharma

 

Schedule G:                                 [   *   ]

of [   *   ]

 

Schedule [   *   ]:        [   *   ]

 

Schedule I:                                     Templates of Certificates of

Analysis for Drug Substance and Drug Product

 

 

IN WITNESS WHEREOF, the Parties have caused

this Agreement to be executed by their duly authorized representatives.

 

	

   

  	

  IMMUNOGEN, INC.

  
	

   

  	

   

  	

   

  	

   

  
	

   

  	

   

  	

   

  	

   

  
	

   

  	

  By:

  	

   

  	

   

  
	

   

  	

   

  	

   

  	

   

  
	

   

  	

  Title:

  	

   

  	

   

  
	

   

  	

   

  	

   

  	

   

  
	

   

  	

   

  	

   

  	

   

  
	

   

  	

  BOEHRINGER INGELHEIM PHARMA KG

  
	

   

  	

   

  	

  ppa.

  	

   

  
	

   

  	

   

  	

   

  	

   

  
	

   

  	

  By:

  	

   

  	

   

  
	

   

  	

   

  	

   

  	

   

  
	

   

  	

   

  	

   

  	

   

  
	

  Authorized

  Signatories:

  	

   

  	

  A. Dehio

  	

  Dr. H. Michelberger

  
							

 

 

G-19

 

Schedule A

[   *   ]

 

 

of

	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  

1[   *   ]

on the [   *   ]

 

of 

	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  

1[   *   ]

on the [   *   ] n

 

A-1

 

Schedule B

[   *   ] of [   *   ]

for [   *   ]

 

[   *   ] /[   *   ]

 

1              [   *   ]

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

 

[   *   ]

 

1                                          [   *   ]

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

 

[   *   ]

 

 

[   *   ]

 

1                                          [   *   ]

1                                          [   *   ]

 

[   *   ]

 

1                                          [   *   ]

                                                    [   *   ]

1                                          [   *   ]

                                                    [   *   ]

 

 

[   *   ]

include [   *   ]

and [   *   ].

 

B-1

 

SCHEDULE C

 

[   *   ]

 

Section [   *   ]

of the Agreement [   *   ]

by the [   *   ] for certain [   *   ] not [   *   ] to [   *   ] .  The [   *   ]

of such [   *   ] shall take place in accordance with the table and description

below.  

 

	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  
	

  [   *   ]

  

  	

  [   *   ]

  

  

 

[   *   ]

 

[   *   ]

represents the [   *   ]

of the [   *   ] that result in [   *   ] that [   *   ] and/or [   *   ] The Parties estimate that for the [   *   ]

, there may be [   *   ]

that result in [   *   ]

and/or Therefore, [   *   ]

may, [   *   ] up to [   *   ] to [   *   ] of [   *   ] five (5) Successful Batch Runs [   *   ]

shall [   *   ] In the event that [   *   ] must [   *   ] than to [   *   ] the [   *   ] of [   *   ] , [   *   ] shall [   *   ] all [   *   ] associated with [   *   ]

 

[   *   ]

 

[   *   ]

estimate that for the [   *   ]

there may be [   *   ]

that result in [   *   ]

and/or [   *   ] Therefore, [   *   ] may [   *   ]up to [   *   ] to[   *   ] of [   *   ]

shall [   *   ] all [   *   ] associated with [   *   ] In the event that [   *   ] must [   *   ] to [   *   ] the of [   *   ] , [   *   ] shall [   *   ]

all [   *   ] associated with [   *   ]

 

[   *   ]

 

For all [   *   ]

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

 

C-1

 

Schedule D

Form of Invoice and [   *   ]

of [   *   ]

 

 

Schedule E

 

List of [   *   ]

 

(1)          For [   *   ]

[   *   ]

 between [   *   ]

and [   *   ]

 

[   *   ]

 

(2)          For [   *   ]

[   *   ]

 for the [   *   ]

of [   *   ] dated [   *   ] and [   *   ]

 

[   *   ]

 

E-1

 

Schedule F

Purchase Order BI Pharma

 

 

Schedule G

 

[   *   ]

 

	

   

  	

  [   *   ]

  
	

   

  	

  [   *   ]

  	

  [   *   ]

  	

  [   *   ]

  	

  [   *   ]

  
	

  [   *   ]

  

  	

  [   *   ]

  	

  [   *   ]

  	

  [   *   ]

  	

  [   *   ]

  

 

 

G-1

 

Schedule H

 

[   *   ] as

of Effective Date

 

[   *   ]

 

[   *   ]

 

H-1

 

Schedule I

 

Template of Certificates of Analysis for Drug

Substance and Drug Product

 

For

Drug Substance:

 

CERTIFICATE OF

ANALYSIS

 

PRODUCT:

 

LOT NUMBER:

 

	

  TEST

  	

  RESULT

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  

This lot of material was manufactured to [       *              ]

and to the approved [       *              ].

 

 

QU Approval: ____________________________     Date: _____________________

 

I-1

 

For

Drug Product:

 

CERTIFICATE OF

ANALYSIS

 

PRODUCT:

 

LOT NUMBER:

 

	

  TEST

  	

  RESULT

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

  	

   

  
	

  [               *              ]

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

   

  	

   

  
	

  [               *              ]

  	

   

  

 

This lot of material was manufactured to [       *              ]

and to the approved [       *              ].

 

 

QU Approval: ____________________________     Date: _____________________

 

I-2

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