Exhibit 10.96


 





 


December 31, 2004


 


Thomas D. Zindrick


Vice President, Law


Amgen Inc.


One Amgen Center Drive


Thousand Oaks, CA 91320-1799


 


Re:                             Amendment
Number 2 to Amgen/InterMune License and Commercialization Agreement for
Infergen


 


Dear Mr. Zindrick:


 


As you know, Amgen Inc. (“Amgen”) and InterMune, Inc. (“InterMune”)
are parties to that certain License and Commercialization Agreement effective June 15,
2001, as first amended April 25, 2002 (the “Agreement”).  The Parties have now agreed to amend the Agreement
to provide for the transfer of certain Amgen technology for manufacturing
Infergen to InterMune and/or InterMune’s contract manufacturer[ * ] in accordance with the terms set
forth in this letter amendment (the “Amendment”).


 


Therefore, for good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, the
Parties hereby agree to amend the Agreement pursuant to this Amendment as
follows:


 


1.                                       This
Amendment is effective as of the Amendment Effective Date.  Capitalized terms used herein and not
otherwise defined will have the same meaning as ascribed thereto in the
Agreement.


 


2.                                       The
following capitalized terms will have the meanings set forth below:


 


(a)                                  “Allowed
Activities” means use on and after the Amendment Effective Date by
InterMune, its Affiliates, its assignees and/or its Authorized Sublicensees, in
accordance with this Amendment, of the Manufacturing Process and any
improvements thereto developed by InterMune or [ * ] on InterMune’s behalf, to develop, manufacture or have
manufactured a Licensed Product for development, use or sale in the Territory.


 


(b)                                 “Amendment
Effective Date” means the date first set forth above.


 










[  *  ] =
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 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.


 





















 


(c)                                  “Amgen
Manufacturing Improvements” means any improvements to the Manufacturing
Process conceived, created or discovered solely by Amgen, its Affiliates or its
licensees (other than InterMune) after the Amendment Effective Date but prior
to the expiration of the Term or the earlier termination of the Agreement.


 


(d)                                 “Amgen
Manufacturing Patents” means all Patents [ *
].  Amgen Manufacturing
Patents will be [ * ] of [ *
] for all purposes under the Agreement.


 


(e)                                  “Amgen
Manufacturing Technology” means: (i) the Manufacturing Process; (ii) all
data, documentation, know-how and trade secrets owned or Controlled by Amgen
relating to the Manufacturing Process to the extent actually provided by Amgen
to InterMune under Section 6 of this Amendment; (iii) the Amgen
Manufacturing Patents; and (iv) the Amgen Materials.  Amgen Manufacturing Technology excludes any
InterMune Manufacturing Improvements.


 


(f)                                    “Amgen
Materials” means the materials set forth in Exhibit 2 hereto and any
other material provided to InterMune and/or [ *
] by Amgen pursuant to Section 6.


 


(g)                                 “Authorized
Sublicensee” means a sublicensee of InterMune’s rights pursuant to Section 3
of this Amendment, the sublicense to whom is permitted pursuant to Section 3(a) or
3(d) of this Amendment.


 


(h)                                 “[ * ] Affiliate” will mean an
entity that, directly or indirectly, through one or more intermediaries,
controls, is controlled by, or is under common control with   [ * ].  For the purposes of this definition, control
will mean the direct, indirect or indirect ownership of greater than fifty
percent (50%) or, if less than fifty percent (50%), the maximum percentage as
allowed by applicable law of (i) the stock shares entitled to vote for the
election of directors or (ii) ownership interest.


 


(i)                                     “CDA”
means the confidentiality and materials transfer agreement substantially in the
form attached hereto as Exhibit 7 hereto to be executed by and among
InterMune, Amgen and [ * ] to
enable the technology transfer activities described in Section 6 hereof to
commence.


 


(j)                                     “Contract
Manufacturer” means a manufacturer of [ *
] Licensed Product [ * ]
and/or [ * ] Licensed Product,
which manufacturer is [ * ]
responsible for such manufacture, although it may [ * ] to perform [ * ]
of the [ * ] Licensed Products.


 


(k)                                  “GMP”
means current Good Manufacturing Practices as defined in the United States Code
of Federal Regulations (21 CFR 210 and 211 et
seq.).


 


(l)                                     “Infergen
BLA” means the BLA for Infergen and any and all updates and supplements
thereto.


 


(m)                               “InterMune
Manufacturing Improvements” means any improvements to the Manufacturing
Process conceived, created or discovered solely by InterMune, its


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


Affiliates or
its sublicensees (other than Amgen) after the Amendment Effective Date but
prior to the expiration of the Term or the earlier termination of the
Agreement.


 


(n)                                 “Manufacturing
Process” means the manufacturing process for Infergen described in the
Infergen BLA (i) as it exists as of the Amendment Effective Date, e.g., in
the CMC section of the BLA and updates to the BLA existing as of the
Amendment Effective Date (such as annual reportable information, GMP requirements,
etc.), and (ii) as such Infergen BLA may be modified by Amgen at any time
after the Amendment Effective Date until the successful completion of the
transfer of the Manufacturing Process to [ *
] (or another Contract Manufacturer, as the case may be) as
contemplated in this Amendment.


 


(o)                                 “Manufacturing
Sublicense” means a sublicense agreement between InterMune and [ * ], or other Contract Manufacturer,
pursuant to which InterMune grants      [ * ] or such other Contract Manufacturer a
sublicense under the license set forth in Section 3 below to contract
manufacture Licensed Products.


 


(p)                                 “Process-Related
Technical Issues” means manufacturing process issues and analytical testing
issues relating solely to the Manufacturing Process identified through GMP
compliance investigations as required by a Regulatory Authority as “Process
Related” and does not include issues identified as “Equipment Related” or “Human
Error Related.”


 


3.                                      (a)                                  Pursuant
to and subject to that certain Amendment to License and Supply Agreement by and
between Amgen and [ * ] dated [ * ] and the License and Supply Agreement
by and between Amgen and [ * ]
dated [ * ] as amended [ * ] Amgen hereby grants to InterMune
during the Term of the Agreement a non-exclusive license under the Amgen Manufacturing
Technology solely for the purposes of InterMune granting a sublicense to [ * ], to solely develop and contract
manufacture (and perform all associated activities relating thereto) Licensed
Products, including without limitation Infergen and PEG-Infergen Product in [ * ] solely for/to InterMune and its
Affiliates and Sublicensees for [ * ]
InterMune and its Affiliates and Sublicensees in the Territory (which
sublicense will include the right for [ * ]
to use [ * ] Affiliates and
subcontractors to perform elements of the [ *
] Licensed Products).  Upon
the prior written consent of [ * ]
Amgen, which consent from Amgen [ * ]
will not be unreasonably withheld or delayed, InterMune may grant a sublicense
under the foregoing license to another Contract Manufacturer [ * ] the identical rights permitted to be
granted to [ * ] pursuant to this Section 3(a)).


 


(b)                                Amgen
hereby grants to InterMune a non-exclusive license under the Amgen
Manufacturing Technology solely to manufacture and have manufactured Licensed
Products in the Territory, provided, however, that InterMune will not
manufacture any Licensed Products or grant any rights to any Third Party to
manufacture Licensed Products for InterMune until and unless Amgen has first
granted its consent thereto pursuant to Section 3(d) below.


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


(c)                                 Amgen
hereby grants to InterMune a non-exclusive sublicense under the Existing
License Patents solely to import, manufacture and have manufactured Infergen in
the Territory, provided, however, that InterMune will not manufacture any
Infergen or grant any rights to any Third Party to manufacture Infergen for
InterMune until and unless Amgen has first granted its consent thereto pursuant
to Section 3(d) below.


 


(d)                                Prior
to manufacturing or engaging any Contract Manufacturer (other than [ * ]) to manufacture any Licensed Product,
InterMune shall provide to Amgen a written request for such manufacturing along
with a reasonably detailed description of the manufacturing activities, the
Contract Manufacturer (if applicable), and upon Amgen’s reasonable request, any
other information that would be helpful to Amgen in evaluating the then current
capabilities of InterMune or such Contract Manufacturer and the extent to which
such Contract Manufacturer (if applicable) is competitive to Amgen.  Within [ *
] days of receiving InterMune’s request and such supplemental
information as Amgen requests pursuant to this Section 3(d), Amgen will
review such request and provide to InterMune its decision about whether to
consent to the proposed manufacturing activities, which consent will not be
unreasonably withheld.  Once Amgen has
approved a sublicense to a particular Contract Manufacturer, Amgen’s further
consent will not be required for such Contract Manufacturer to use its
affiliates and subcontractors to perform elements of the manufacturing, filling
and finishing of Licensed Products.


 


The licenses
set forth in this Section 3 are granted [ *
] or [ * ] other than
as set forth in      [ * ] of the Agreement.  Notwithstanding any sublicensing of InterMune’s
rights and obligations hereunder to [ *
] or other Authorized Sublicensees, InterMune will remain
responsible for the full and complete performance of all of InterMune’s
obligations and duties hereunder and under the Agreement.  Nothing herein is intended to alter the
exclusive rights granted to InterMune by Amgen in Article 2 of the
Agreement.  InterMune’s licenses set
forth this Section 3 will, upon expiration of the Agreement as set forth
in Section 13.1 thereof, automatically convert to being irrevocable and
fully-paid.


 


4.                                       Amgen
hereby covenants that during the period of InterMune’s licenses set forth in Section 3
hereof, neither Amgen, nor any Amgen Affiliate or assignee (the “Amgen
Covenantors”) will sue InterMune, its Affiliates, its assignees and/or
Authorized Sublicensees for infringement of any Patent or know-how owned or
Controlled by any Amgen Covenantor (but excluding the Amgen Manufacturing
Technology), or under which any Amgen Covenantor has the right to sue
infringers, solely to the extent InterMune, its Affiliates, its assignees
and/or its Authorized Sublicensees are performing Allowed Activities.  The covenant in this Section 4 is
expressly subject to InterMune’s and its Affiliates’, assignees’ and/or
sublicensees’ continuous compliance with all of the terms and conditions of
this Amendment and the Agreement.


 


For the
avoidance of doubt, nothing set forth in the Agreement or this Amendment will
preclude Amgen from using the Amgen Manufacturing Technology or granting a
license to the Amgen Manufacturing Technology to a Third Party, in each case
for: [ * ].


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


5.                                       Amgen
will provide InterMune and [
* ] with access
to the [ * ] Infergen BLA.  InterMune will be the license holder for the
Infergen BLA and any supplements thereto. 
As between Amgen and InterMune, [ *
] for interacting with Regulatory Authorities and for obtaining all
necessary Regulatory Approvals for the manufacturing of Infergen by     [ * ]
for use or sale in the Territory.


 


6.                                       Amgen
will provide support (not to exceed [ *
] hours for technical support and [
* ] hours of regulatory support, except as set forth herein below)
to InterMune as requested by InterMune, as solely limited to the following:


 


(a)                                  assisting
InterMune in developing a plan to transfer the Manufacturing Process (a
preliminary form of transfer plan is attached as Exhibit 4 hereto);


 


(b)                                 assisting
InterMune in the transfer of the Manufacturing Process to [ *
]; and


 


(c)                                  providing
relevant manufacturing know-how and documentation set forth on Exhibit 5 hereto
(which Amgen will complete within [ * ]
days from the Amendment Effective Date, except for relevant manufacturing
know-how and documentation set forth on Exhibit 5 hereto that relates to
tasks and processes currently performed at [
* ] which Amgen will complete within [ * ] days after the Amendment Effective Date; provided,
however, that in the event that InterMune provides written notice to Amgen of
specific know-how and documentation that relates to tasks and processes
currently performed at [ * ] and
the reason that the same is needed prior to the end of such [ * ] day [
* ] period then Amgen shall use reasonable efforts to endeavor to
provide the requested know-how and documentation sooner) and such other
know-how and documentation necessary to manufacture Infergen as InterMune
reasonably requests, provided that such
know-how and documentation exists and Amgen would not have to [ * ] and that Amgen’s obligation to
deliver such know-how and documentation will be limited to Amgen’s obligations
to provide support under this Section 6, and further provided that InterMune hereby acknowledges that [ * ] may not have been [ * ] Amgen and therefore may [ * ] to be [ * ] hereunder.


 


InterMune acknowledges that Amgen has already
expended, but not yet invoiced InterMune for, approximately [ *
] hours of technical support expended in [ * ], which will be deemed deducted from such [ * ] hours of technical support described
above. In its sole discretion, Amgen may provide additional support beyond the
hour limits stated above upon InterMune’s reasonable request.  InterMune and Amgen will each endeavor to
manage blocks of time for coordinating technical transfer discussions, issues
and manufacturing site interactions with Amgen and [ * ] so as to minimize [ *
], in accordance with the preliminary transfer plan attached as Exhibit 4
hereto.  During the first [ * ] months and [ * ] days from the Amendment Effective Date, the Parties will
hold [ * ] meetings with the
appropriate technical personnel from InterMune and Amgen, and at InterMune’s
request, [ * ], no less than [ * ] as described in more detail in the
Communications Plan attached hereto as Exhibit 8.  Where practicable, such meeting will be held
at [ * ]. 
Amgen’s technical support obligations under Sections 6(a), (b) and (c) above
with respect to transfer of the Manufacturing Process will not extend beyond [ * ]


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


months from the execution of the CDA (the “Initial
Support Term”), subject to subsection (i) below, and provided that Amgen’s obligation to
provide up to [ * ] hours of regulatory support will
continue until such time as [ * ]
receives FDA approval to manufacture bulk and finished Infergen for commercial
supply.


 


Amgen will [
* ], and InterMune will [ * ]
Amgen under this Section 6 in accordance with the Additional Work
provision in Exhibit F of the Agreement as well as [ * ] Amgen’s      [ * ]
including, without limitation, [ * ].  All such [ *
] will be [ * ] in
accordance with Amgen’s then-current [ * ]
policy.


 


Solely in the event that, prior to InterMune
providing a notice to Amgen pursuant to Section 14(b) below and prior
to InterMune obtaining regulatory approval for the production of any Licensed
Product at [ * ], the
Manufacturing Process transfer is [ * ]
by Process-Related Technical Issues that [ *
] Amgen will:


 


(i)                                     use
such efforts as [ * ] (if any) to render the Manufacturing
Process transferable, which will be at its own expense once the above-mentioned
[ * ] hours of technical support
have been utilized; and


 


(ii)                                  notwithstanding
Section 14(a), continue to manufacture and supply Infergen on behalf of
InterMune as specified in the Agreement prior to this Amendment.


 


Issues related
to changes to the Manufacturing Process by InterMune or [ * ] after the Amendment Effective Date
will be deemed not to be Process-Related Technical Issues, and will be [ * ] sole responsibility.


 


Each Party
will designate in writing to the other Party a project leader, which individual
will be a person of appropriate experience, skill and knowledge to oversee such
Party’s activities under this Section 6. 
If any dispute between the Parties arises relating to Amgen’s provision
of support under this Section 6, then either Party may give written notice
thereof to the other Party.  Within [ * ] days of receipt of such notice, the
project leaders will meet and attempt in good faith to resolve such disputed
issue.  If such project leaders are
unable to resolve any such issue within [ *
] days after receipt of such notice, then such issue will be dealt
with as set forth in Section 14.1 of the Agreement.


 


7.                                       (a)                                  InterMune
will obtain a covenant from [
* ] (and any
other Contract Manufacturer [ * ])
that provides that such Contract Manufacturer will:


 


(i)                                     during
the term of the applicable Manufacturing Sublicense, work exclusively with
InterMune and/or its Affiliates, assignees and/or Sublicensees on the
development and contract manufacturing of Licensed Product and will not, on its
own behalf and/or on behalf of a Third Party, enter into any agreement, render
services or otherwise supply any Licensed Product to any Third Party other than
InterMune and its Affiliates, assignees and/or sublicensees whereby such
agreement, service or supply would conflict with the exclusivity obligations of
such Contract Manufacturer set forth hereinabove; and


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


(ii)                                  during
the term of the [ * ]: (x)
maintain in confidence all Amgen Manufacturing Technology to the same extent
such Contract Manufacturer maintains its own proprietary industrial information
of similar kind and value (but at a minimum such Contract Manufacturer will use
commercially reasonable efforts to maintain such Amgen Manufacturing Technology
in confidence); and (y) keep confidential and will not publish or otherwise
disclose and will not use for any purpose other than such development and
contract manufacturing for/to InterMune and its affiliates and sublicensees
Amgen Manufacturing Technology, provided,
however, that: (A) such Contract Manufacturer will not be
restricted by the provisions of this sentence with respect to Amgen Manufacturing
Technology that: (1) is publicly disclosed by [ * ] Amgen, either before or after it becomes known to such
Contract Manufacturer; (2) was known to such Contract Manufacturer,
without obligation to keep it confidential, prior to when it was received from
InterMune or Amgen, as demonstrated by competent written proof; (3) is
subsequently disclosed to such Contract Manufacturer by a Third Party lawfully
in possession thereof without obligation to keep it confidential; (4) has
been publicly disclosed other than by [ * ]
Amgen and without breach of an obligation of confidentiality with respect
thereto; or (5) has been independently developed by such Contract
Manufacturer without the aid, application or use of Amgen Manufacturing
Technology, as demonstrated by competent written proof; provided, however that
this clause (5) shall not be interpreted to implicate to any extent
InterMune Manufacturing Improvements and (B) such Contract Manufacturer
may disclose Amgen Manufacturing Technology to the extent and to the persons
and entities as required by an applicable law, rule, regulation, legal process,
court order or the rules of the National Association of Securities Dealers
or of the FDA or its Canadian equivalents or any successor thereto.


 


InterMune’s
obligations under this subsection (a) will expire simultaneously with
Amgen’s obligation to [ * ] that the above covenants be maintained;
provided that no such expiration will relieve InterMune of its confidentiality
obligations under the Agreement.


 


(b)                                 Prior
to Amgen commencing the delivery of any Amgen Materials or Amgen Manufacturing
Technology to or on behalf of InterMune under this Amendment, and for so long
as subsection (a) remains in effect, InterMune will provide to Amgen [ * ] of [ *
] necessary to demonstrate compliance with all of the obligations of
this Section 7 for [ * ]
governing any [ * ] which
agreement(s) will contain provisions required under subsection (a) above.  All of the licenses granted by Amgen and
obligations of Amgen under this Amendment are expressly conditioned upon
InterMune obtaining the provisions described in subsection (a) above
of this Amendment and [ * ] to enforce such provisions during the
Term.


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


(c)                                  If
[ * ] to [ *
] by the obligations set forth in Sections 7(a), 7(c) and 9 of
this Amendment, and InterMune is [ * ]
a suitable [ * ] then InterMune
will give Amgen written notice thereof. 
In such event, InterMune will reimburse Amgen for all of its costs
incurred in performing its obligations under this Amendment, and InterMune may thereafter
terminate this Amendment upon providing written notice of such termination to
Amgen.


 


8.                                       Amgen
retains all rights, title and interest in and to the Amgen Technology and Amgen
Manufacturing Technology and will have the right to use the Manufacturing
Process and/or transfer the Manufacturing Process (and/or the right to access
and reference the Infergen BLA as it exists as of the Amendment Effective Date)
to one or more Third Parties solely to enable such Third Parties to manufacture
products that are not Licensed Products for any reason and to manufacture
products comprising Licensed Products for the sole purpose of commercializing
such product(s) outside the Territory.


 


9.                                       InterMune
hereby covenants that it and its Affiliates, assignees and sublicensees
(collectively, “InterMune Covenantors”) will not sue any Amgen Covenantor, for
infringement of any Patent owned or Controlled by any InterMune Covenantor, or
under which any InterMune Covenantor has the right to sue infringers, in each
case claiming any InterMune Manufacturing Improvements, with respect to any
product containing [ * ] by any
Amgen Covenantor thereof for use and/or sale outside the Territory during the
Term.  InterMune will automatically be
deemed to have extended the foregoing covenant to any licensee of any Amgen
Covenantor [ * ] any product
containing [ * ], which licensee
has provided to InterMune, in writing, a covenant identical to that set forth
in Section 11, for so long as such licensee’s covenant remains in effect.


 


10.                                 Amgen
will have a complete and unrestricted right to reference the Infergen BLA held
by InterMune, its Affiliates, assignees and/or sublicensees, including all
updates and supplements thereto, for the sole purpose of manufacturing Infergen
for InterMune, its Affiliates, assignees and/or sublicensees until the
expiration or termination of all of Amgen’s obligations to manufacture Infergen
for InterMune and/or its Affiliates, assigns and/or sublicensees, but
thereafter Amgen will have no right of reference to any updates or supplements
to the Infergen BLA filed by InterMune or its Affiliates or sublicensees after
the Amendment Effective Date.


 


(a)                                  Upon
termination of the Agreement (except InterMune’s termination for Amgen’s
material breach), InterMune will be deemed to have hereby granted to Amgen
a    [
* ] non-exclusive license, with the right to grant sublicenses,
under the InterMune Manufacturing Improvements (including, without limitation,
InterMune Manufacturing Improvements conceived, created or discovered by [ * ] (or any other Contract
Manufacturer)), solely to the extent necessary to update the Manufacturing
Process and to use for any filings with Regulatory Authorities relating to the
Manufacturing Process and for the operation of the Manufacturing Process as
improved.


 


(b)                                 Nothing
in subsection (a) above will require InterMune to provide Amgen with
access to: (i) [ * ] developed by or for InterMune or its
Affiliates or sublicensees,


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


or (ii) any
confidential or proprietary information of any Third Party.  Notwithstanding the foregoing, in the event
of a Third Party claim against Amgen arising from InterMune’s use of the
Manufacturing Process (as improved by any InterMune Manufacturing
Improvements), InterMune will provide Amgen, at Amgen’s expense, access to the
InterMune Manufacturing Improvements (including but not limited to any [ * ] developed by or for InterMune or its
Affiliates or sublicensees) solely in order for Amgen to defend against such
Third Party claim.


 


Nothing in
this Section 10 is intended to prevent the Parties from entering into one
or more separate agreements or arrangements to provide Amgen access to any
InterMune Manufacturing Improvements on such terms as the Parties may agree in
their respective sole and absolute discretion.


 


11.                                 All
Amgen Manufacturing Improvements will be owned solely and exclusively by
Amgen.  Subject to Section 4 above,
InterMune will have no right or license to any Amgen Manufacturing
Improvement.  Notwithstanding the
foregoing, Amgen hereby covenants that no Amgen Covenantor will sue any
InterMune Covenantor for infringement of any Patent owned or Controlled by any
Amgen Covenantor, or under which any Amgen Covenantor has the right to sue
infringers, in each case claiming any Amgen Manufacturing Improvements, with respect
to any Licensed Product manufactured by any InterMune Covenantor thereof for
use and/or sale within the Territory during the period of InterMune’s licenses
set forth in Section 3 hereof.


 


THE AMGEN MANUFACTURING IMPROVEMENTS ARE
PROVIDED “AS IS,” AND AMGEN MAKES NO REPRESENTATIONS OR WARRANTIES WITH RESPECT
TO ANY AMGEN MANUFACTURING IMPROVEMENTS, INCLUDING WITHOUT LIMITATION ANY
WARRANTY OF TITLE, FITNESS FOR PARTICULAR PURPOSE, MARKETABILITY OR
NON-INFRINGEMENT OF ANY THIRD PARTY PROPRIETARY RIGHT.  NO AMGEN COVENANTOR WILL HAVE ANY LIABILITY
TO ANY INTERMUNE COVENANTOR RELATING TO SUCH INTERMUNE COVENANTOR’S USE OF ANY
AMGEN MANUFACTURING IMPROVEMENT.


 


12.                                 InterMune
will have no right of reference to any updates or supplements to any BLA for a
product comprising [ * ] filed by Amgen or its Affiliates,
licensees or sublicensees after the successful completion of the transfer of
the Manufacturing Process to [ * ]
(or another Contract Manufacturer, as the case may be) as contemplated in this
Amendment.


 


(a)                                  Upon
termination of the Agreement (except Amgen’s termination for InterMune’s
material breach), Amgen will be deemed to have hereby granted to InterMune
a    [ *
], non-exclusive license, with the right to grant sublicenses, under
the Amgen Manufacturing Improvements, solely to the extent necessary to update
the Manufacturing Process and to use for any filings with Regulatory
Authorities relating to the Manufacturing Process and for the operation of the
Manufacturing Process as improved.


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


(b)                                 Nothing
in subsection (a) above will require Amgen to provide InterMune with
access: to (i) any [ * ] developed by or for Amgen or its
Affiliates or sublicensees, or (ii) any confidential or proprietary
information of any Third Party. 
Notwithstanding the foregoing, in the event of a Third Party claim
against InterMune arising from Amgen’s use of the Manufacturing Process (as
improved by any Amgen Manufacturing Improvements), Amgen will provide
InterMune, at InterMune’s expense, access to the Amgen Manufacturing Improvements
(including but not limited to any [ * ]
developed by or for Amgen or its Affiliates or sublicensees) solely in order
for InterMune to defend against such Third Party claim.


 


Nothing in
this Section 12 is intended to prevent the Parties from entering into one
or more separate agreements or arrangements to provide InterMune access to any
Amgen Manufacturing Improvements on such terms as the Parties may agree in
their respective sole and absolute discretion.


 


13.                                 InterMune
will be [ * ] for [ * ] associated with all work Amgen
performs pursuant to Sections 6 and 14 of this Amendment in accordance with the
“Additional Work” provisions of Exhibit F of the Agreement.  Amgen will [ *
] InterMune no more frequently than [ * ] for all such work. 
InterMune will [ * ] within [
* ] days of receipt.


 


14.                                 (a)                                 In
accordance with InterMune’s expected Regulatory Approval by [ * ] and subject to Amgen’s obligations
under Sections 5 and 6 of this Amendment, Amgen’s commitment to manufacture
Infergen pursuant to Exhibit F of the Agreement will be changed to the schedule provided
below, unless InterMune notifies Amgen in writing pursuant to Exhibit F,
Rolling Forecast section of the Agreement:


 


(i)                                    [ * ]


 


(ii)                                 [ * ]


 


Amgen will provide
InterMune with its production schedules and inventory reports for Infergen at
least [ * ] for so long as Amgen manufactures Infergen for
InterMune.


 


(b)                               If, prior to the dates set forth in subsection (a) above,
the Rolling Forecast provides for no Infergen to be manufactured, InterMune
reserves the right to provide written notice to Amgen that Amgen will no longer
be required to produce [ * ] Infergen
following a specified date (an “End Date”). 
In any event, InterMune shall also have the right to provide [ * ] month written notice
to Amgen that Amgen will no longer be required to produce [ * ] Infergen following a specified date (also, an “End
Date”).  Upon the earlier of Amgen’s
receipt of either type of written notice described in this Section 14(b) or
InterMune’s receipt of Regulatory Approval for [ * ] or other Contract Manufacturer to manufacture
Infergen for commercial use in the Territory, Amgen shall automatically and
irrevocably be released of all obligations to manufacture, supply and/or
provide


 










[ 
*  ] = 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
OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


assistance relating thereto following an
applicable End Date or the date of InterMune’s receipt of Regulatory Approval; provided, however:


 


(i)                                     at InterMune’s written request, Amgen shall complete
any then-current work-in-progress and InterMune shall promptly take all
necessary actions, with Amgen’s reasonable cooperation, to remove Amgen’s name
from the Infergen BLA; and


 


(ii)                                  unless otherwise requested in writing by InterMune,
Amgen will remain responsible for continuing to perform all on-going regulatory
obligations required of pharmaceutical manufacturers by the FDA for all
Infergen manufactured by Amgen for InterMune, including without limitation
stability testing.  Such work will be [ * ] in accordance with
the “Additional Work” provisions of Exhibit F of the Agreement.


 


Nothing in this subsection (b) is
intended to release Amgen from its obligations under Section 4.7 of the
Agreement or under Sections 5(e), 6, 11, 12 and 13 of the [
* ].


 


(c)                                The work described in subsections (b)(i) and (ii) above will be [ * ] in accordance with the “Additional Work” provisions
of Exhibit F of the Agreement.


 


(d)                               Notwithstanding InterMune obtaining Regulatory
Approval for [ * ] or other Contract Manufacturer to manufacture Infergen, InterMune
shall remain obligated to purchase remaining [ * ] Infergen manufactured, or in the process of being
manufactured, by Amgen, based on the Rolling Forecast. Concurrently with Amgen’s
final invoice for such Infergen, Amgen shall deliver to InterMune an invoice
for a [ * ] (or [ * ] as applicable) representing the [ * ] between the [ * ] for [ * ] Infergen and [
* ] Infergen charged to InterMune based on the
then-established [ * ] for the last
applicable fiscal year (based on Amgen’s fiscal year), or portion thereof and
Amgen’s actual [ * ] for manufacturing
Infergen for the same period.  Such [ * ] (or [ * ] as applicable) will not include the [ * ] for any work for which Amgen [ * ] InterMune under the “Additional Work” provisions of
Exhibit F of the Agreement.


 


15.                                 The
forecast for [ * ] Infergen and [ * ] for the next [ * ] quarters attached hereto as Exhibit 6
(the “New Forecast”) will have the effect of replacing the previous
Rolling Forecast provided by InterMune under the Agreement for each quarter so
forecasted.


 


16.                                 Each
Party hereby confirms to the other Party that the indemnity and insurance
obligations set forth in Sections 10.2 and 10.3 of the Agreement remain in full
force and effect and will apply to all of the responsibilities under the
Agreement, including the manufacture, distribution, marketing and sale of
Licensed Products.  InterMune further
agrees that beginning on the date InterMune (or its Affiliates, assignees,
sublicensees, subcontractors, co-promoters/co-marketers and distributors) first
offers for sale a Licensed Product not manufactured by Amgen, InterMune will
maintain product liability insurance with reasonable deductibles and aggregate
coverage limits for the Licensed


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


Products no lower than [ * ] U.S. dollars [ * ] which limits are not intended to be
construed as (x) a limit to the obligations set forth in Section 10.3 of
the Agreement, (y) a measure of adequate insurance to cover InterMune’s
obligations under the Agreement, nor (z) a limit to the InterMune’s liability
with respect to indemnification obligations under the Agreement.


 


17.                                 Amgen
hereby represents and warrants that Amgen has sufficient rights in and to the
Amgen Manufacturing Technology and the Amgen Technology to grant the rights set
forth in this Amendment.


 


Except as
expressly stated herein, all terms and conditions of the Agreement will remain
in full force and effect.


 


If you are in agreement with the terms of this Amendment, please have
an authorized representative of your company sign the two (2) enclosed
originals, and return them to the attention of [ * ] at InterMune.  We
will return one fully executed original for your records.


 


	
  Sincerely,

  
	
   

  
	
  /s/ Daniel Welch

  	
   

  
	
  Daniel G. Welch

  
	
  President and CEO

  
	
  InterMune, Inc.

  



 


 


Accepted and Agreed:


 


	
  Amgen Inc.

  
	
   

  	
   

  
	
  By:

  	
  /s/ T.D. Zindrick

  	
   

  
	
   

  	
   

  
	
  Name:

  	
  Thomas D. Zindrick

  	
   

  
	
   

  	
   

  
	
  Title:

  	
  Vice President, Law

  	
   

  
	
   

  	
   

  
	
  Date:

  	
  1/13/2005

  	
   

  
						



 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


EXHIBIT
1


 


Amgen
Manufacturing Patents


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


EXHIBIT 1


 


AMGEN CONSENSUS INTERFERON
PATENTS/APPLICATIONS


 


[
* ]


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


EXHIBIT
2


 


Amgen
Materials


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


Exhibit 2


 


Amgen
Materials


 


[
* ]


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


EXHIBIT
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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


[
* ]


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


EXHIBIT
4


 


Preliminary
Transfer Plan


 










[  *  ] =
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 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.


 





















 


[
* ]


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


EXHIBIT
5


 


Documentation


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


EXHIBIT
5


 


Documentation


 


[
* ]


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


EXHIBIT
6


 


Forecast


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


[ * ]


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


EXHIBIT 7


 


Form of CDA


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


CONFIDENTIAL DISCLOSURE
AGREEMENT


 


[
* ]


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


EXHIBIT 8


 


Communications Plan


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


 





















 


COMMUNICATION PLAN


 


[
* ]


 










[ 
*  ] = 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 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.