[ * ] = 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.
Dr. Kurt
Konopitzky
Head Division Biopharmaceutical Operations
Boehringer Ingelheim Austria GmbH
Dr. Boehringer-Gasse 5 — 11
A-1121 Vienna, Austria
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Re:
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Amendment No. 3 to the Data
Transfer, Clinical Trial and Market Supply Agreement, dated as of
January 27, 2000
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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:
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1.
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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.
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2.
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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 [ * ] .
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3.
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The
Agreement is hereby amended to delete the second (2
nd
) paragraph of
Section 3.2.1 and replace such paragraph with the
following:
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“Following BI Austria’s
and BI Pharma KG’s FDA approval to manufacture
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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.”
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4.
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The
first sentence of Section 3.2.6 of the Agreement shall be
deleted and replaced with the following sentence:
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“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”).”
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5.
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The
Agreement is hereby amended to add the following language at the
end of Section 3.3.4:
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“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
[
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