Exhibit 10.1


 


 


TERMINATION OF THE
DEVELOPMENT, COMMERCIALIZATION


 


AND


 


LICENSE AGREEMENT


 


MADE BETWEEN VERNALIS
(R&D) LIMITED


 


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


 

















 


TERMINATION OF THE DEVELOPMENT,
COMMERCIALIZATION AND LICENSE AGREEMENT MADE BETWEEN VERNALIS (R&D) LIMITED
(THEN BRITISH BIOTECH PHARMACEUTICALS LIMITED) AND IMMUNOGEN INC, ON 4TH
MAY 2000.


 


This Termination Agreement (this “Agreement”)
is effective as of January 7, 2004 (the Termination Effective Date”), by
and between ImmunoGen, Inc. (“ImmunoGen”), a Massachusetts corporation with a
principal place of business at 128 Sidney Street, Cambridge, MA 02139, U.S.A
and Vernalis (R&D) Limited (“Vernalis”), an English corporation with a
principal place of business at Oakdene Court, Winnersh, Berkshire, RG41 5UA,
United Kingdom.


 


WHEREAS, ImmunoGen and Vernalis have
previously entered into a Development, Commercialization and License Agreement
dated as of May 4, 2000, as supplemented by a letter agreement (the “Letter
Agreement”) dated as of August 2, 2002 (as so supplemented, the “Existing Agreement”);
and


 


WHEREAS, ImmunoGen and Vernalis wish to
terminate the Existing Agreement effective as of the Termination Effective
Date, and wish to set forth herein the mutual understanding of the parties as
to the consequences of such termination.


 


NOW, THEREFORE, in consideration of the
mutual covenants and agreements set forth herein and for other valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, the
undersigned hereby agree as follows:


 


1.                                       Defined terms in the Existing Agreement shall be deemed to have the
same meaning herein.


 


In addition the following terms shall have
the following meanings:


 


“Contingent Payment” means (a) *****(*****)
if ***** patients have been enrolled to the US Study prior to 30th
June 2004 and (i) not all of those patients have been completed at 30th
June 2004 or (ii) all of those patients have been completed and there is
***** or (b) *****(*****) if enrolment of the first ***** patients to
the US Study has not completed by 30th June 2004.


 


“Compound Supply Batch” means the batch of
P009031001 sent to Vernalis by ImmunoGen as described on the invoice attached
hereto as Exhibit A and incorporated herein by reference.


 


“Compound Supply Payment” means  *****.


 


“UK Study” means the ongoing UK phase I daily
dosing study (C10/IVB/002)


 


“US Study” means the ongoing US phase II
weekly dosing study (C10/IVB/001)


 


References to dollars are to US dollars.  References to ***** shall be interpreted in
accordance with the protocol for US Study. 
A patient shall be deemed to be enrolled when he/she has received
his/her first dose of Licensed Compound.


 


2.                                       Vernalis and ImmunoGen hereby terminate the Existing Agreement with
effect from the Termination Effective Date. 
Such termination is subject to the terms of this Agreement.  In deciding to effect such termination, both
parties have taken into account the other provisions of this Agreement.  Except as otherwise expressly provided in this
Agreement, as of the Termination Effective Date, all rights, obligations, and
licenses of the parties under the Existing Agreement shall terminate and be of
no further force and effect.  In
connection therewith, effective as of the Termination Effective Date, each of
ImmunoGen and Vernalis hereby releases the other and its respective officers,
employees, Affiliates and agents from any and all


 

















 


claims, actions or causes of action by it and
arising from or related to the Existing Agreement, the transactions
contemplated thereby or the termination thereof; provided, that, this Section 2
shall not be interpreted to release either ImmunoGen or Vernalis from any
obligation expressly set forth in this Agreement, including, without
limitation, their respective continuing obligations set forth in clause 10
below.


 


3.                                       Vernalis shall use all reasonable efforts to complete the UK Study
no later than ***** and to make a preliminary report on the results to
ImmunoGen no later than ***** (*****) ***** after the last patient last visit
for the UK Study in accordance with the protocol therefor.


 


4.                                       Vernalis shall use all reasonable efforts to complete the enrolment
to the US Study of the initial ***** patients (as contemplated by the protocol
for the US Study) by 30th June 2004.  Such reasonable efforts shall consist solely of keeping open all
of the sites that are open as at 1st December 2003 and making
at least ***** per site between 1st January 2004 and 30th
June 2004 and making a preliminary report on the results to ImmunoGen no
later than ***** (*****) ***** after the earlier   of (a) completion of the last patient last visit for the first
****** patients enrolled to the US Study and (b) 30th
June 2004.


 


5.                                       Vernalis is permitted to sub-contract the performance of any work to
be carried out by Vernalis under this Agreement to any third party or third
parties of Vernalis’ choosing, provided that Vernalis shall remain primarily
responsible to ImmunoGen for the performance of any such third party or third
parties.


 


6.                                       Vernalis’s final obligations as regards the US Study shall depend on
the status of the US Study as at 30th June 2004:


 


6.1         if *****
patients complete the US Study prior to 30th June 2004 but
there are ***** then Vernalis shall terminate the US Study, following which its
only obligations shall be to report the results to ImmunoGen as described in
clause 4 of this Agreement.


6.2         if (a)
***** patients complete the US Study prior to 30th June 2004
and there is at ***** or (b) enrolment of the first ***** patients to the US
Study has completed by 30th June 2004 but not all such patients
have been completed at that date (regardless of whether there have been *****),
or (c) enrolment of the first ***** patients to the US Study does not complete
(regardless of whether there have been *****), Vernalis shall immediately
transfer all responsibilities, including the IND and sponsorship of the US
Study, to ImmunoGen or its nominee (so that ImmunoGen can then complete the US
Study, or terminate it, as it sees fit), and Vernalis shall  provide such documentation and execute such
documents as may be reasonably necessary to effect such transfer to ImmunoGen
and, following this, Vernalis shall have no further obligations in respect of
the US Study. Documents shall only qualify as ‘reasonably necessary’ in this
context if ImmunoGen has made a request in writing to Vernalis, no later than
*****, that Vernalis supply such documents to ImmunoGen. In addition, upon
request from ImmunoGen, the parties shall discuss in good faith the possibility
of entering into a consulting agreement containing commercially reasonable
terms relating to certain consulting services to be performed by medically
qualified persons in connection with ImmunoGen’s conduct of the US Study post
30 June 2004.  If the parties do
not enter into such a consulting agreement, Vernalis shall, if requested by
ImmunoGen, suggest to ImmunoGen a third party consultant who ImmunoGen may wish
to use for such purposes.


 


7.                                       ImmunoGen shall supply Vernalis with the Compound Supply Batch in
accordance with the Specifications. If Vernalis requires any further supplies
of Licensed Compound in order for Vernalis to carry out its obligations under
clauses 3 and 4 above then ImmunoGen shall supply the same in accordance with
the Letter Agreement.   Clauses 22.5 to
22.9, 23, 25.1, 25.2, 26 and 28 of the Existing Agreement shall apply to such
supply save that in no circumstances shall Vernalis be obliged to make any
payment to ImmunoGen under such clauses and if there


 

















 


is any conflict between the terms of this
Agreement and such clauses then this Agreement shall prevail.


 


8.                                       Vernalis acknowledges and agrees that ImmunoGen has sent Vernalis
the invoice for the Compound Supply Payment attached hereto as Exhibit A and
incorporated herein by reference. 
Vernalis shall use all reasonable endeavours to expedite the procedures
for the release of the Compound Supply Batch and shall pay ImmunoGen the
Compound Supply Payment within ***** (*****) ***** of such release by Vernalis.
If release is not ***** then the parties shall meet and discuss in good faith a
resolution of such issues.  Vernalis
shall also pay ImmunoGen the Contingent Payment if (and only if) any of the
scenarios set out in clause 6.2 occur. Vernalis shall not make the Contingent
Payment if ***** patients complete the US Study by 30 June 2004 and there
are not ***** amongst such patients. 
Vernalis shall make such payment (if applicable) within 30 days of
ImmunoGen sending Vernalis an invoice therefore (such invoice to be dated 30th
June 2004 or thereafter).   In
connection therewith (a) Vernalis acknowledges and agrees that ImmunoGen has
paid to Vernalis any and all amounts due and payable by ImmunoGen to Vernalis
under the Existing Agreement, and (b) ImmunoGen acknowledges and agrees that,
other than with respect to the payment of the Compound Supply Payment and (if
applicable) the Contingent Payment as described in this clause 8, Vernalis has
paid to ImmunoGen any and all amounts due and payable by Vernalis to ImmunoGen
under, or in connection with, the Existing Agreement.


 


9.                                       Neither party shall make any public announcements, either written,
oral or in any medium relating to the Existing Agreement, this Agreement, or
Licensed Compound without the consent of the other party (such consent not to
be unreasonably withheld).  Nothing in
the foregoing however shall prohibit a party from making disclosures to the
extent required under applicable federal or state securities laws or any rule
or regulation of any nationally recognised securities exchange, provided same
is accurate and complete.


 


10.                                 Clauses 47.2.1, 47.2.2, 47.2.4 (effect of termination), 53 (other
than 53.3) (confidentiality) and 56 (standstill) of the Existing Agreement
shall survive termination of the Existing Agreement.


 


11.                                 This Agreement shall be governed by and construed and interpreted in
accordance with the Laws of the State of New York and the parties submit to the
jurisdiction of the State or Federal courts 
located in the City of New York, New York, which courts have exclusive
jurisdiction in respect thereof.


 


This agreement has been executed on the
7thJanuary 2004


 


	
  Executed by Vernalis (R&D) Limited

  acting by

  	
   

  	
  /s/ Simon Sturge

  	
   

  
	
   

  	
   

  	
  Director

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Executed by ImmunoGen, Inc

  acting by

  	
   

  	
  /s/ Mitchel Sayare

  	
   

  
	
   

  	
   

  	
  Chief Executive Officer

  



 

















 


Exhibit A


 


*****


 


 


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