exv10w1



 





[ * ] = Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule
24b-2 on the Securities Exchange Act of 1934, as amended.




Exhibit 10.1




July 26, 2005




Dr. Kurt Konopitzky

Head Division Biopharmaceutical Operations

Boehringer Ingelheim Austria GmbH

Dr. Boehringer-Gasse 5 — 11

A-1121 Vienna, Austria





			
	Re:	 	Amendment No. 3 to the Data Transfer, Clinical Trial and Market Supply Agreement, dated as of
January 27, 2000








Dear Mr. Kanzler;




          As you know, InterMune, Inc. (“InterMune”) and Boehringer Ingelheim Austria GmbH (“BI
Austria”) are parties to that certain Data Transfer, Clinical Trial and Market Supply Agreement
effective January 27, 2000, as amended effective June 19, 2002 and as further amended effective
September 18, 2003 (the “Agreement”). This letter (this “Amendment”) will confirm our agreement to
amend and supplement the Agreement as follows, effective as of the date first set forth above:




	 	1.	 	The parties hereby agree that InterMune’s obligation to purchase [ * ] of [ *
] vials of the PRODUCT for [ * ] pursuant to Section 3.2.1 of the Agreement is
hereby waived without further payment or any liability or penalty to InterMune with
regard to the aforementioned waiver.
	 
	 	2.	 	The parties hereby agree that InterMune’s obligation to purchase [ * ] of [ *
] vials of the PRODUCT for [ * ] pursuant to Section 3.2.1 of the Agreement shall be
[ * ] vials for such [ * ] without liability or penalty to InterMune with regard to
the aforementioned [ * ] . The parties further hereby agree that with respect to such
[ * ] vials that InterMune is required [ * ] to purchase in [ * ] pursuant to
Section 3.2.1 of the Agreement after giving effect to the modification thereto as set
forth in this Section 3 of this Amendment, such vials will be produced by BI Austria in
the [ * ] for delivery to InterMune in the [ * ] and such vials will have [ * ] of
in the second calendar quarter of [ * ] .
	 
	 	3.	 	The Agreement is hereby amended to delete the second (2nd) paragraph
of Section 3.2.1 and replace such paragraph with the following:






	 	 	“Following BI Austria’s and BI Pharma KG’s FDA approval to manufacture




 









 






	 	 	PRODUCT for market supply, InterMune shall order the requested amounts of
PRODUCT. In any case, the [ * ] of PRODUCT ordered by InterMune shall be as
follows: [ * ] per year for delivery in each calendar year through calendar year [
* ] ; (ii) [ * ] vials of PRODUCT per year for delivery in [ * ] ; provided,
however, that for [ * ] , the [ * ] of PRODUCT ordered by InterMune shall be [ * ]
vials of Product and provided, further, that for [ * ] , instead of InterMune having
any [ * ] , InterMune, for the remainder of the term of the Agreement, shall [ * ]
annual purchases of PRODUCT [ * ] equal to [ * ] such that if at the end of a
given year InterMune purchases less than [ * ] in PRODUCT, InterMune shall pay to
BI Austria the difference between [ * ] and that amount in PRODUCT actually
purchased by InterMune during such year.”






	 	4.	 	The first sentence of Section 3.2.6 of the Agreement shall be deleted and
replaced with the following sentence:






	 	 	     “If InterMune determines that [ * ] vials of PRODUCT, or the [ * ] as
applicable, per year exceeds InterMune’s annual requirements for PRODUCT [ * ]
then InterMune may so notify BI Austria, stating the number of vials of PRODUCT
or the [ * ] , as applicable, that InterMune predicts will actually require
going forward from the date of InterMune’s notice (the “Revised Level”).”






	 	5.	 	The Agreement is hereby amended to add the following language at the end of
Section 3.3.4:






	 	 	“With respect to PRODUCTS ordered by InterMune for [ * ] requirements, the
number of vials supplied by BI Austria shall not exceed the number of vials
subject to the applicable purchase order submitted by InterMune; provided,
however, that if the number of vials BI Austria is able to supply [ * ] the
number of vials ordered by InterMune in such purchase order and [ * ] is [ * ]
the number ordered by InterMune, BI Austria shall notify InterMune in writing
and inquire as to whether [ * ] is acceptable and if not, whether BI
Austria should [ * ] . If InterMune notifies BI Austria that such [ * ] is
acceptable to InterMune, then the applicable purchase order shall be deemed to
be amended to provide for [ * ] and BI Austria shall be deemed to have accepted
such purchase order in accordance with Section 3.3. On the other hand, if
InterMune notifies BI Austria that BI Austria should [ * ] , then BI Austria
shall be obligated to produce [ * ] InterMune shall be obligated to purchase
[ * ] vials of PRODUCT produced by BI Austria from [ * ] and the purchase
order submitted to BI Austria by InterMune shall be deemed amended to account [
* ] resulting from the [ * ] and such purchase order shall be deemed accepted
by BI Austria in accordance with Section 3.3.”




[ * ] = certain confidential information contained in this document, marked by brackets, has been
omitted and filed separately with the securities and exchange
commission pursuant to rule 24b-2 on the securities exchange act
of 1934, as amended.




 









 









	 	6.	The Agreement is hereby amended to add a new Section 3.7.3 after Section 3.7.2
hereof as follows:
	 
	 	 	“3.7.3 	    In addition, the parties, through the STEERING COMMITTEE shall work together in
good faith to develop a risk mitigation plan to minimize any risk of interruption
in the supply of PRODUCT for use in clinical trials and market supply, which plan
may include, among other things, [ * ] and/or [ * ] .”






	 	7.	 	The Agreement is hereby amended by adding at the end of Section 4.1 the
following paragraph:
	 
	 	 	 	     “Payments by InterMune to BI Austria hereunder shall be in Euros; provided,
however, that on each invoice, the applicable exchange rate to convert Euros to US
Dollars as of the invoice date shall be noted. For purposes of InterMune’s payments to
BI Austria hereunder, the foreign currency exchange rate will be [ * ] such that any
gain or loss resulting from exchange rate fluctuation outside [ * ] of the [ * ] will
be shared [ * ] between BI Austria and InterMune and payments owed by InterMune to BI
Austria will be adjusted to reflect such sharing of foreign exchange risks.”






	 	8.	 	The Agreement is hereby amended by deleting Section 13.1 in its entirety and
replacing it with the following:






	 	 	 	“13.1 Duration






	 	 	 	The Agreement shall be effective as of the Effective Date and shall continue
in force until December 31, 2012. This Agreement shall automatically renew
for successive four (4) year periods, provided, however, that either Party
may elect not to renew this Agreement by providing the other Party written
notice of such election at least thirty-six (36) months prior to the date of
expiration of the then-current term. In addition, in the event that results
from InterMune’s Phase III clinical trial for idiopathic pulmonary fibrosis
(GIPF 007) (“Inspire Trial”) and/or InterMune’s Phase III clinical trial for
ovarian cancer (GIOV-001) (“Graces Trial”) are positive so as to cause
InterMune to decide to proceed with filing a BLA, InterMune shall have the
option exercisable with prior written notice to BI Austria to extend the
initial term of the Agreement from December 31, 2012 to a period of time up
to December 31, 2021.”






	 	9.	 	The Agreement is hereby amended to delete in its entirety Section 14.4 and
replace it with the following:






	 	 	 	“14.4 Notices




[ * ] = certain confidential information contained in this document, marked by brackets, has been
omitted and filed separately with the securities and exchange
commission pursuant to rule 24b-2 on the securities exchange act
of 1934, as amended.




 









 









	 	 	 	Any notice required or permitted to be given hereunder by either Party shall
be in writing and shall be (i) delivered personally, (ii) sent by registered
mail, return receipt requested, postage prepaid or (iii) delivered by
facsimile and confirmed by certified or registered mail to the addresses or
facsimile numbers set forth below:





	 	 	 	 	 
	 

	 	If to InterMune:
	 	InterMune, Inc.
	 

	 	 	 	3280 Bayshore Boulevard
	 

	 	 	 	Brisbane, CA 94005 USA
	 

	 	 	 	Facsimile: +1 — 415 — 466 — 2300
	 

	 	 	 	Attention: Russell Kawahata
	 
	 	 	 	 
	 

	 	with a copy to:
	 	InterMune, Inc.
	 

	 	 	 	3280 Bayshore Boulevard
	 

	 	 	 	Brisbane, CA 94005 USA
	 

	 	 	 	Facsimile: +1 — 415 – 466-2300
	 

	 	 	 	Attention: General Counsel
	 
	 	 	 	 
	 

	 	If to BI Austria:
	 	Boehringer Ingelheim Austria GmbH
	 

	 	 	 	Dr. Boehringer-Gasse 5 – 11
	 

	 	 	 	A-1121 Vienna, Republic of Austria
	 

	 	 	 	Facsimile: +43 – 1 – 801 05 – 2440
	 

	 	 	 	Attention: Monika Henninger
	 

	 	 	 	Business Support Biotech
	 
	 	 	 	 
	 

	 	with a copy to:	 	 
	 

	 	 	 	Boehringer Ingelheim GmbH
	 

	 	 	 	Binger Strasse 173
	 

	 	 	 	D-55 216 Ingelheim am Rhein
	 

	 	 	 	Facsimile: +49 – 61 32 77 – 98 287
	 

	 	 	 	Attention: Rolf G. Werner
	 

	 	 	 	Corporate Division Biopharmaceuticals”







	 	10.	 	The parties understand and agree that InterMune intends [ * ] to [ * ] in [ *
] The parties [ * ] in good faith [ * ] for the performance by BI Austria of
appropriate [ * ] required in order to [ * ] in [ * ] As a result, the parties, as
of the date hereof, have [ * ] which sets forth [ * ] A copy [ * ] is attached
hereto as Exhibit A, which [ * ] may be revised as agreed upon [ * ] Provided that [
* ] is successful, both parties intend for [ * ] to become [ * ] Accordingly, the
parties agree that they will [ * ] to [ * ] for the [ * ] by BI Austria, consistent
with [ * ] and the pricing at which BI Austria [ * ] and other related terms and
conditions, all of which will be set forth in a separate amendment, addendum or
agreement upon [ * ]




[ * ] = certain confidential information contained in this document, marked by brackets, has been
omitted and filed separately with the securities and exchange
commission pursuant to rule 24b-2 on the securities exchange act
of 1934, as amended.




 









 









	 	 	 	Except as set forth above, all terms and conditions of the Agreement will remain in full force and
effect. Any capitalized term used herein and not otherwise defined will have the same meaning as
set forth in the Agreement. In the event of any conflict between this Amendment and the Agreement,
the terms of this Amendment shall govern to the extent of such conflict.
	 
	 	 	 	Please acknowledge your agreement to the above by countersigning both enclosed copies of this
letter where indicated below, and returning one original to the attention of Lucinda Y. Quan,
Director, Legal Affairs at InterMune, Tel: (415) 466-2223, Fax: (415) 466-2323. We would be happy
to proceed based on receipt of a facsimile copy while awaiting the original.






	 	 	 	 	 
	 

	Sincerely,	 	 
	 
	 	 	 	 
	 

	/s/ Russell Kawahata	 	 
	 
	 	 	 	 
	 

	Russell Kawahata	 	 
	 

	Vice President, Technical Operations
	  Acknowledged and Agreed:
	 
	 	 	 	 
	 

	InterMune, Inc.
	  Boehringer Ingelheim Austria GmbH
	 
	 	 	 	 
	 

	By:	/s/ Roger Hawley	  By:  	/s/ Kurt Konopitzky
	 

	 	 
	 	 
	 

	 	Roger Hawley,
	 	Dr. Kurt Konopitzky
	 

	 	Executive Vice President
	 	Head Division Biopharmaceuticals
	 

	 	Of Commercial and Technical Operations
	 	Division
	 
	 	 	 	 
	 

	Date: July 26, 2005
	  Date: July 26, 2005
	 
	 	 	 	 
	 

	 	 	  Boehringer Ingelheim Austria GmbH
	 
	 	 	 	 
	 

	 	 	  By:  	/s/ Monika Henninger
	 

	 	 	 	 
	 

	 	 	 	Dr. Monika Henninger
	 

	 	 	 	Head, Customer Relations & Projects
	 
	 	 	 	 
	 

	 	 	  Date: July 26, 2005





[ * ] = certain confidential information contained in this document, marked by brackets, has been
omitted and filed separately with the securities and exchange
commission pursuant to rule 24b-2 on the securities exchange act
of 1934, as amended.




 









 








EXHIBIT A




[ * ]



[ * ] = certain confidential information contained in this document, marked by brackets, has been
omitted and filed separately with the securities and exchange
commission pursuant to rule 24b-2 on the securities exchange act
of 1934, as amended.




 









 













Biopharmaceuticals/Operations




[ * ]




[ * ]



[ * ] = certain confidential information contained in this document, marked by brackets, has been
omitted and filed separately with the securities and exchange
commission pursuant to rule 24b-2 on the securities exchange act
of 1934, as amended.