EXHIBIT 10.30
***TEXT OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(B)(4)
AND 240.24B-2.
(INTERMUNE (R) LOGO)
December 31, 2004
Xxxxxx X. Xxxxxxxx
Vice President, Law
Amgen Inc.
Xxx Xxxxx Xxxxxx Xxxxx
Xxxxxxxx Xxxx, XX 00000-0000
RE: AMENDMENT NUMBER 2 TO AMGEN/INTERMUNE LICENSE AND COMMERCIALIZATION
AGREEMENT FOR INFERGEN
Dear Xx. Xxxxxxxx:
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.
***Confidential Treatment Requested
(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
***Confidential Treatment Requested
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.
***Confidential Treatment Requested
(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 xxx 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 xxx 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: [***].
***Confidential Treatment Requested
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 [***]
***Confidential Treatment Requested
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
***Confidential Treatment Requested
(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.
***Confidential Treatment Requested
(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 xxx 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 xxx 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,
***Confidential Treatment Requested
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 xxx 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
xxx 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.
***Confidential Treatment Requested
(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
***Confidential Treatment Requested
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
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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/ Xxxxxx Xxxxx
-------------------------------------
Xxxxxx X. Xxxxx
President and CEO
InterMune, Inc.
Accepted and Agreed:
AMGEN INC.
By: /s/ X.X. Xxxxxxxx
---------------------------------
Name: Xxxxxx X. Xxxxxxxx
Title: Vice President, Law
Date: 1/13/2005
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EXHIBIT 1
AMGEN MANUFACTURING PATENTS
EXHIBIT 1
AMGEN CONSENSUS INTERFERON PATENTS/APPLICATIONS
[***]
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EXHIBIT 2
AMGEN MATERIALS
Exhibit 2
Amgen Materials
[***]
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EXHIBIT 3
[***]
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[***]
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EXHIBIT 4
PRELIMINARY TRANSFER PLAN
[***]
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EXHIBIT 5
DOCUMENTATION
EXHIBIT 5
DOCUMENTATION
[***]
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EXHIBIT 6
FORECAST
[***]
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EXHIBIT 7
FORM OF CDA
CONFIDENTIAL DISCLOSURE AGREEMENT
[***]
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EXHIBIT 8
COMMUNICATIONS PLAN
COMMUNICATION PLAN
[***]
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