[ * ] = Certain information on this document has
been redacted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portions.
EXHIBIT 10.71
FIRST AMENDMENT
TO
EXCLUSIVE LICENSE AND
COLLABORATION AGREEMENT
This First Amendment (this “
Amendment ”) to the Exclusive License and
Collaboration Agreement effective as of October 16, 2006, (the
“Agreement” ) is made effective as of
October 16, 2008 (the “ Amendment Effective Date
”) and entered into by and between Hoffmann-La Roche
Inc. , a New Jersey corporation located at 340 Kingsland
Street, Nutley, New Jersey 07110 ( “Roche
Nutley” ), and F.Hoffmann-La Roche Ltd , a Swiss
corporation, with its principal office at Grenzacherstrasse 124,
CH-4070 Basel, Switzerland ( “Roche Basel” ;
Roche Nutley and Roche Basel are collectively referred to as
“Roche” ), on the one hand, and InterMune,
Inc. , a Delaware corporation with its principal place of
business at 3280 Bayshore Boulevard, Brisbane, California 94005 (
“InterMune” ), on the other hand.
WHEREAS, InterMune and Roche wish to amend the Agreement
to (i) extend the Research Program Term (and consequently [
* ] ) for an additional amount of time set forth herein;
(ii) provide for Roche’s funding of a certain number of
InterMune FTEs assigned to the Research Program as well as certain
Third Party vendor costs incurred in connection with the Research
Program during the extended Research Program Term,
(iii) provide Roche a credit for such funding amounts against
certain future Licensed Compound Payment(s); and (iv) to
extend the period during which Roche may substitute Licensed
Compounds for a period of [ * ] ( [ * ] ) months
following the expiration of the Research Program Extension
Term.
NOW, THEREFORE,
in consideration of the foregoing
premises and the mutual covenants herein contained, and for good
and valuable consideration, the receipt and sufficiency which are
hereby acknowledged, Roche and InterMune hereby agree as
follows:
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1.
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Any capitalized
term not otherwise defined herein shall have the meaning ascribed
to it in the Agreement.
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2.
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The Parties
acknowledge that the Research Program Term expired on [ * ]
under the existing terms and conditions of the Agreement. The
Parties hereby agree to extend the Research Program Term for an
additional [ * ] ( [ * ] ) year period commencing as
of [ * ] and ending on [ * ] (the “ Research
Program Extension Term ”), provided however, that Roche
shall have the option to terminate the Research Program Extension
Term prior to [ * ] in accordance with Section 5 of
this Amendment. As a result of this Amendment, the definition of
“Research Program Term” for purposes of the Agreement
shall include the Research Program Extension Term, with the express
exception of Section 12.2 of the Agreement and with the
express amendment to Section 6.1.1 as set forth in this
Section 2. The Parties agree that the [ * ] provided
for in the Agreement shall [ * ] ; provided, however that
[ * ] is hereby amended to [ * ] .
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3.
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The Parties shall work together
to modify the Research Plan, as appropriate, to specify the ongoing
activities of the Research Program during the Research Program
Extension Term
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1
[ * ] = Certain information on this document has
been redacted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portions.
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consistent with the guidelines
set forth in Schedule 1.1 attached to this Amendment
(“ Schedule 1.1” ). For purposes of the Research
Program Extension Term, the definition of “Research
Program” under the Agreement, as amended by this Amendment,
shall include those activities contemplated in the revised Research
Plan.
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4.
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During the
Research Program Extension Term, Roche shall fund [ * ]
percent ( [ * ] %) of the Research Program activities as
follows:
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A.
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From the [ *
] until [ * ] , Roche shall fund [ * ] ( [ *
] ) InterMune FTEs assigned to the Research Program, and from
[ * ] through [ * ] , Roche shall fund [ * ] (
[ * ] ) InterMune FTEs assigned to the Research Program;
provided, however, that Roche shall have no obligation to fund more
than the [ * ] ( [ * ] ) and the [ * ] ( [
* ] ) InterMune FTEs set forth herein unless mutually agreed to
by the Parties. For purposes hereof, Roche shall fund the InterMune
FTEs at an FTE rate equal to CHF [ * ] ( [ * ] ) for
[ * ] , which FTE rate will then increase yearly by [ *
] percent ( [ * ] %) beginning on [ * ] . On a
Calendar Quarter basis, InterMune shall invoice Roche for the
actual FTEs used at the FTE rate set forth herein that were
incurred during the relevant Calendar Quarter and payment for each
invoice shall be made by Roche to InterMune at the same time cash
settlement is made between the Parties based on the Reconciliation
Statement process described in Section 1.6 of Exhibit A
attached to the Agreement.
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B.
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During the
Research Program Extension Term, Roche shall [ * ] , which
use shall be consistent with the Research Plan and the guidelines
set forth in Schedule 1.1 . Furthermore, the Parties agree
that the JRC shall continually review, discuss and monitor the use
of various Third Party vendors and the incurrence of costs from
such use. On a Calendar Quarter basis, InterMune shall provide to
Roche copies of all invoices received by such Third Party vendors
to evidence such actual costs incurred during the relevant Calendar
Quarter and [ * ] .
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5.
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In the event
that Roche, in its sole discretion, has not selected a
Collaboration Compound for evaluation by [ * ] , Roche shall
have the right to terminate the Research Program Extension Term
prior to [ * ] by providing [ * ] ( [ * ] )
days prior written notice to InterMune; provided, however, that the
effective date of termination of the Research Program Extension
Term shall in no event be earlier than [ * ] . If Roche
terminates the Research Program Extension Term, prior to [ *
] , then the [ * ] shall automatically terminate
effective upon delivery of the written notice sent to InterMune
pursuant to this Section. In addition, in the event InterMune
undergoes and closes a Change of Control transaction at any time
during the Research Program Extension Term, the Research Program
Extension Term and the [ * ] shall automatically terminate
upon the closing of such Change of Control transaction. However,
Roche’s obligation [ * ] of termination of the
Research Program Extension Term shall survive such early
termination and Roche will [ * ] as a result of the Research
Program.
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6.
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For purposes of clarification,
without limiting the scope of the Original Agreement, each and
every [ * ] in the Field (together with its salts and
esters), other than ITMN-191, resulting from the Research Program
during the Research Program Term (including the Research Program
Extension Term), shall be deemed a Collaboration Compound, treated
as such and subject to the terms and condition of the Agreement, as
amended; provided, however that
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2
[ * ] = Certain information on this document has
been redacted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect
to the omitted portions.
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when such [ * ] is deemed
a Collaboration Compound hereunder, the Parties agree that such
Collaboration Compound is not necessarily deemed “Controlled
by InterMune” as set forth in the definition of Collaboration
Compound in Section 1.30 of the Agreement and that
determination of whether an invention was made by one Party or
jointly by the Parties shall continue to be governed under Article
10 of the Agreement.
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7.
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By way of
background, the Agreement currently provides that in connection
with the Parties’ Co-Funded Development of ITMN-191 under the
Agreement, Roche shall provide to InterMune a Co-Funded Development
Plan therefor as described in Section 4.3.7(a)(iii) of the
Agreement and InterMune shall have the right to exercise its [ *
] in the case of [ * ] . The Agreement also currently
provides that in the event InterMune does not exercise its [ *
] in the case of ITMN-191 based on the applicable ITMN-191
Co-Funded Development Plan provided by Roche to InterMune under
Section 4.3.7(a)(iii) of the Agreement for such
decision-making purposes by InterMune, Roche shall bear all [ *
] or [ * ] incurred in the ITMN-191 Development that
exceeds [ * ] percent ( [ * ] %) in total of the
initial ITMN-191 Co-Funded Development Budget included in such
ITMN-191 Co-Funded Development Plan presented by Roche to
InterMune.
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As a subpart of the Co-Funded
Development of ITMN-191, the Parties are currently planning to
engage in the Development of ITMN-191 [ * ] (“
STAT-C ”) [ * ] . With respect to such ITMN-191
STAT-C Development, due to the difficulty at the present time in
determining the appropriate budget for the STAT-C Development part
of the ITMN-191 Co-Funded Development Plan, the Parties hereby
a
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