<PAGE>
EXHIBIT 10.28
***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.
LICENSE
AND COMMERCIALIZATION AGREEMENT
BY AND BETWEEN
AMGEN INC.
AND
INTERMUNE, INC.
JUNE 15, 2001
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TABLE OF CONTENTS
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ARTICLE 1 DEFINITIONS
1
1.1 "Active Component"
1
1.2 "Affiliate"
1
1.3 "Amgen Know-How"
1
1.4 "Amgen Trademarks"
1
1.5 "Amgen Patent"
2
1.6 "Amgen Technology"
2
1.7 "BLA"
2
1.8 "CMC"
2
1.9 "Combination Product"
2
1.10
"Commercialize"
or "Commercialization"
2
1.11
"Commercially
Reasonable Efforts"
2
1.12
"Confidential
Information"
2
1.13
"Control"
2
1.14
"Default"
2
1.15
"Directly
Competitive Product"
2
1.16
"Dollar"
2
1.17
"Drug Approval
Application"
2
1.18
"Existing
License"
3
1.19
"Existing
License Patents"
3
1.20
"Existing
Licensor"
3
1.21
"FDA"
3
1.22
"Force Majeure"
3
1.23
"GAAP"
3
1.24
"Infergen"
3
1.25
"IND"
3
1.26
"Interferon
alfacon-1"
3
1.27
"Licensed
Product"
3
1.28
"Losses"
3
1.29
"Net Sales"
3
1.30
"Ongoing
Clinical Trials"
3
1.31
"Other Licensee"
3
1.32
"Patent"
3
1.33
"PEG Know-How"
4
1.34
"PEG Patent"
4
1.35
"PEG Program"
4
1.36
"PEG-Infergen
Product"
4
1.37
"Phase III
Clinical Trial"
4
1.38
"Phase IV
Clinical Trial"
4
1.39
"Planning Period
Date"
4
1.40
"Regulatory
Approval"
4
1.41
"Regulatory
Authority"
4
1.42
"Royalty" or
Royalties"
4
1.43
"Sublicensee"
4
1.44
"Supply Terms"
4
1.45
"Term"
4
1.46
"Territory"
4
1.47
"Third Party"
4
1.48
"Trademark"
4
1.49
"Valid Claim"
5
ARTICLE 2 LICENSES; EXCLUSIVITY; TRADEMARKS
5
2.1 Technology Ownership
5
2.2 Patent License to
InterMune
5
2.3 Trademark and
Copyright Licenses to InterMune
5
2.4 Know-How License to
InterMune
5
2.5 Sublicenses
5
2.6 Sublicensed Technology
6
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2.7 Exclusivity
7
2.8 Retained Rights.
7
2.9 Import
7
2.10
Covenant.
7
ARTICLE 3 DEVELOPMENT
7
3.1 Ongoing Clinical
Trials.
7
3.2 PEG--Infergen Products
7
3.3 Development Efforts.
8
3.4 Amgen Interim
Activities.
8
3.5 Development Data.
8
3.6 Development Activities
in Territory.
8
ARTICLE 4 REGULATORY
8
4.1 General
8
4.2 Additional Regulatory
Filings
9
4.3 InterMune Access to
Amgen Regulatory Data
9
4.4 Adverse Event
Reporting; Customer Complaints
9
4.5 Communications
10
4.6 Applications for
Regulatory Exclusivity
10
4.7 Recalls and Voluntary
Withdrawals.
10
4.8 Safety and Clinical
Database
10
ARTICLE 5 COMMERCIALIZATION
11
5.1 Pricing
11
5.2 Diligence
11
5.3 Reports
11
5.4 Amgen Transition
Assistance
11
5.5 Change of Promotional
Material
11
5.6 Medical and Other
Inquiries
11
5.7 Trade Returns;
Reimbursements
12
5.8 Distribution
Agreements
12
ARTICLE 6 COMPENSATION
13
6.1 License Fee
13
6.2 Amgen Performance
Milestones.
13
6.3 Product Milestones
13
6.4 Royalties
14
6.5 Term of Royalties
14
6.6 Combination Products
14
6.7 Existing License
Royalties
14
6.8 Royalty Payments and
Reports
15
6.9 Taxes
15
6.10
Blocked Currency
15
6.11
Foreign Exchange
15
6.12
Patent and
Trademark Expenses
15
6.13
Late Payments
15
ARTICLE 7 MANUFACTURE AND SUPPLY
16
7.1 General.
16
ARTICLE 8 INTELLECTUAL PROPERTY
16
8.1 Ownership of
Inventions
16
8.2 Prosecution of Patents
16
8.3 Infringement of
Patents and Trademarks by Third Parties
16
8.4 Infringement of Third
Party Rights
17
8.5 Patent Marketing
17
ARTICLE 9 REPRESENTATIONS AND WARRANTIES
18
9.1 Mutual Representations
and Warranties
18
9.2 Mutual Covenants
18
9.3 Representations,
Warranties and Covenants of InterMune
18
9.4 Representations,
Warranties and Covenants of Amgen
19
ARTICLE 10
20
10.1
Indemnification
by Amgen
20
10.2
Indemnification
by InterMune
20
10.3
Insurance
20
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10.4
Pre-Effective
Date Losses.
21
10.5
Limitation of
Liability
21
ARTICLE 11 RECORDS; ROYALTY AUDIT; PUBLICATIONS
21
11.1
Records; Royalty
Audit
21
11.2
Publications
21
ARTICLE 12 CONFIDENTIALITY
22
12.1
Treatment of
Confidential Information
22
12.2
Authorized
Disclosure
22
12.3
Publicity; Terms
of Agreement
22
ARTICLE 13 TERM AND TERMINATION
23
13.1
Term
23
13.2
Discontinuation
of Commercialization or Further Development
23
13.3
Termination for
Default
23
13.4
Licenses Upon
Expiration
23
13.5
Survival
24
13.6
Determination of
PEG Diligence.
24
ARTICLE 14 DISPUTE RESOLUTION
24
14.1
Disputes
24
14.2
Governing Law;
Judicial Resolution
24
14.3
Patent and
Trademark Dispute Resolution
25
ARTICLE 15 MISCELLANEOUS
25
15.1
Entire
Agreement; Amendment
25
15.2
Force Majeure
25
15.3
Notices
25
15.4
Maintenance of
Records
26
15.5
No Strict
Construction
26
15.6
Assignment
26
15.7
Performance by
Affiliates
26
15.8
Counterparts
26
15.9
Severability
26
15.10
Headings
27
15.11
Further Actions
27
15.12
Independent
Contractors
27
15.13
Use of Name
27
15.14
No Waiver
27
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iii
<PAGE>
LICENSE AND COMMERCIALIZATION AGREEMENT
THIS
LICENSE AND COMMERCIALIZATION AGREEMENT (the "Agreement") is
made
effective as of the 15th day of June, 2001 (the "Effective Date")
by and between
AMGEN INC., a Delaware corporation having its principal place of
business at One
Amgen Center Drive, Thousand Oaks, CA 91320-1799 ("Amgen") and
INTERMUNE, INC.,
a Delaware corporation having its principal place of business at
1710 Gilbreth
Road, Suite 310, Burlingame, CA 94010-1317 ("InterMune"). Amgen and
InterMune
are sometimes referred to herein individually as a "Party" and
collectively as
the "Parties", and references to "InterMune" and "Amgen" shall
include their
respective Affiliates.
RECITALS
WHEREAS, Amgen has bioengineered, developed, obtained regulatory
approval
for, and currently markets in the United States and Canada a
pharmaceutical
composition containing a novel, non-naturally occurring Type 1
interferon, sold
under the trademark Infergen(R);
WHEREAS, InterMune has clinically developed and currently markets
an
interferon-gamma product in the United States, and therefore has
both clinical
development experience and a sales force that may be particularly
well suited to
market and further develop a product such as Infergen;
WHEREAS, InterMune desires to obtain, and Amgen wishes to grant
InterMune,
the exclusive license to commercialize and further develop Infergen
in the
United States and Canada on the terms and conditions set forth
herein; and
WHEREAS, Amgen is willing to supply InterMune, and InterMune wishes
to be
supplied by Amgen, with quantities of Infergen (as such term is
defined below)
on the Supply Terms (as defined below);
NOW
THEREFORE, based on the foregoing premises and the mutual covenants
and
obligations set forth below, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
The
following terms shall have the following meanings as used in
this
Agreement:
1.1
"ACTIVE COMPONENT" shall mean any product other than the
Licensed
Product which [***] therapeutic or prophylactic function when
combined with the
Licensed Product.
1.2
"AFFILIATE" shall mean, except as provided below, a Person
that,
directly or indirectly, through one or more intermediaries,
controls, is
controlled by or is under common control with Amgen or InterMune.
For purposes
of this definition, "control" shall mean the possession, direct or
indirect, of
the power to cause the direction of the management and policies of
a Person,
whether through ownership of fifty percent (50%) or more of the
voting
securities of such Person, by contract or otherwise. Affiliate
[***] shall [***]
1.3
"AMGEN KNOW-HOW" shall mean the following information: (1)
information
disclosed in the BLA for Infergen as of the Effective Date, (2)
information
disclosed as of the Effective Date in any BLA supplements for
Infergen, (3) all
Amgen-sponsored investigator-driven clinical trial results, and the
results of
the Ongoing Clinical Trials, (subject to any contractual
confidentiality
obligations of Amgen to Third Parties regarding such results); (4)
Infergen
sales and marketing training materials; (5) any regulatory data
which Amgen
provides to InterMune pursuant to Section 4.3; (6) [***]; (7) the
safety and
clinical database referenced in Section 4.8; and (8) Formulating
Know-How (as
defined in Section 12.1 of Exhibit F).
1.4
"AMGEN TRADEMARKS" shall mean the registered trademarks listed
at
EXHIBIT A, all trademark applications listed at EXHIBIT A and all
trademarks
issuing from such applications, together with any renewals,
modifications or
extensions thereto.
***Confidential Treatment Requested
1
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1.5
"AMGEN PATENT" shall mean [***]
1.6
"AMGEN TECHNOLOGY" shall mean all Amgen Patents, Amgen Know-How
and
Amgen Trademarks.
1.7
"BLA" shall mean a Biological License Application for
Regulatory
Approval filed in the United States.
1.8
"CMC" shall mean the Chemistry Manufacturing Control section of a
BLA.
1.9
"COMBINATION PRODUCT" shall have the meaning assigned such term
pursuant to Section 6.6.
1.10
"COMMERCIALIZE" OR "COMMERCIALIZATION" shall mean those
activities
relating to the promotion, marketing and sale of Licensed Products
and shall
include without limitation, Phase IV Clinical Trials or equivalent
clinical
trials conducted following Regulatory Approval to market a
pharmaceutical
product.
1.11
"COMMERCIALLY REASONABLE EFFORTS" shall mean the level of efforts
and
resources required to Commercialize a Licensed Product in a
sustained manner
consistent with the efforts a similarly situated biopharmaceutical
company would
typically devote to a product of similar market potential, profit
potential or
strategic value resulting from its own research efforts, based on
conditions
then prevailing. Commercially Reasonable Efforts shall be
determined on a
country-by-country (each country including its territories) basis
for a
particular Licensed Product, and it is anticipated that the level
of effort will
change over time reflecting changes in the status of the Licensed
Product and
the country (including its territories) involved.
1.12
"CONFIDENTIAL INFORMATION" shall mean all information received
by
either Party from the other Party pursuant to this Agreement, other
than that
portion of such information or materials which:
(A) is publicly disclosed by the disclosing Party, either before
or
after it becomes known to the receiving Party;
(B) was known to the receiving Party, without obligation to keep
it
confidential, prior to when it was received from the disclosing
Party;
(C) is subsequently disclosed to the receiving Party by a Third
Party
lawfully in possession thereof without obligation to keep it
confidential;
(D) has been publicly disclosed other than by the disclosing Party
and
without breach of an obligation of confidentiality with respect
thereto; or
(E) has been independently developed by the receiving Party
without
the
aid, application or use of Confidential Information, as
demonstrated by
competent written proof.
1.13
"CONTROL" shall mean possession of the ability to grant a license
or
sublicense as provided for herein under such intellectual property
right without
violating the terms of any agreement or other arrangement with any
Third Party.
1.14
"DEFAULT" shall mean with respect to either Party (i) that any
representation or warranty of such Party set forth herein shall
have been untrue
in any material respect when made or (ii) such Party, such Party's
Affiliate or
such Party's sublicensee shall have failed to materially perform
any material
obligation set forth herein.
1.15
"DIRECTLY COMPETITIVE PRODUCT" shall mean any pharmaceutical
product
that contains [***] or [***] of such [***] and that [***] with
[***] in [***]
such Licensed Product [***]
1.16
"DOLLAR" shall mean a United States dollar, and "$" shall be
interpreted accordingly.
1.17
"DRUG APPROVAL APPLICATION" shall mean an application for
Regulatory
Approval required before commercial sale or use of a Licensed
Product as a drug
or to treat a particular indication in a regulatory jurisdiction,
including
without limitation applications to expand the label of an approved
drug.
***Confidential Treatment Requested
2
<PAGE>
1.18
"EXISTING LICENSE" shall mean that certain Agreement between
[***]
1.19
"EXISTING LICENSE PATENTS" shall mean the Patents under which
Amgen
has a license pursuant to the Existing License, a copy of which has
been
provided to InterMune.
1.20
"EXISTING LICENSOR" shall mean [***]
1.21
"FDA" shall mean the United States Food and Drug Administration,
or
any successor thereto.
1.22
"FORCE MAJEURE" shall mean any occurrence beyond the reasonable
control of a Party that prevents or substantially interferes with
the
performance by the Party of any of its obligations hereunder, if
such occurs by
reason of any act of God, flood, fire, explosion, breakdown of
plant,
earthquake, strike, lockout, labor dispute, casualty or accident,
or war,
revolution, civil commotion, acts of public enemies, blockage or
embargo, or any
injunction, law, order, proclamation, regulation, ordinance, demand
or
requirement of any government or of any subdivision, authority or
representative
or any such government, inability to procure or use materials,
labor, equipment,
transportation, or energy sufficient to meet manufacturing needs
without the
necessity of allocation, or any other cause whatsoever, whether
similar or
dissimilar to those above enumerated, beyond the reasonable control
of such
Party, if and only if the Party affected shall have used reasonable
efforts to
avoid such occurrence and to remedy it promptly if it shall have
occurred.
1.23
"GAAP" shall mean United States generally accepted accounting
principles.
1.24
"INFERGEN" shall mean the product containing Interferon alfacon-1
for
which Amgen has obtained Regulatory Approval in each country of the
Territory
prior to the Effective Date, in either bulk or filled and finished
form.
1.25
"IND" shall mean Investigational New Drug application.
1.26
"INTERFERON ALFACON-1" shall mean the polypeptide having the
amino
acid sequence which is set forth in EXHIBIT C.
1.27
"LICENSED PRODUCT" shall mean any product comprising Interferon
alfacon-1 or [***] Licensed Products include but are not limited to
Infergen.
1.28
"LOSSES" shall mean suits, claims, actions, demands,
liabilities,
expenses and/or losses, including without limitation reasonable
legal expenses
and attorneys' fees.
1.29
"NET SALES" shall mean all revenues recognized in accordance with
GAAP
from the sale or other disposition of Licensed Products by
InterMune, its
Affiliates or Sublicensee to a Third Party, less [***]
Amounts received by InterMune, its Affiliates or Sublicensees for
the sale
of Licensed Products among InterMune, its Affiliates and
Sublicensees for resale
shall not be included in the computation of Net Sales hereunder.
Distributors of
InterMune selling Licensed Products shall not be deemed to be
Sublicensees of
InterMune.
1.30
"ONGOING CLINICAL TRIALS" shall mean those clinical trials listed
at
Exhibit E hereto, which are clinical trials of Infergen that Amgen
is conducting
in the Territory as of the Effective Date. For avoidance of doubt,
Ongoing
Clinical Trials shall exclude any Amgen-sponsored
investigator-driven clinical
trials. Amgen represents that the Ongoing Clinical Trials are the
only clinical
trials of Infergen being conducted in the Territory by or on
Amgen's behalf as
of the Effective Date.
1.31
"OTHER LICENSEE" shall mean any Third Party to which Amgen has
granted
or grants a license and/or sublicense to develop or Commercialize a
Licensed
Product outside the Territory, including without limitation
[***]
1.32
"PATENT" shall mean (i) an issued, unexpired patent (with the
term
"patent" being deemed to encompass, without limitation, an
inventor's
certificate) which has not been held invalid or unenforceable by a
court of
competent jurisdiction from which no appeal can be taken or has
been taken
within the
***Confidential Treatment Requested
3
<PAGE>
required time period, including without limitation any
substitution, extension,
registration, confirmation, reissue, re-examination, renewal or any
like filing
thereof or (ii) a pending application for a patent, including
without limitation
any provisional, converted provisional, continued prosecution
application,
continuation, divisional or continuation-in-part thereof; any
patents issuing
therefrom; and any substitution, extension, registration,
confirmation, reissue,
reexamination, renewal or like filing thereof.
1.33
"PEG KNOW-HOW" shall mean any of the following which is
conceived,
reduced to practice, developed or employed by Amgen (solely or
jointly with
InterMune) [***] the PEG Program: (i) techniques and data
specifically relating
to (but not necessarily solely to) the [***] of PEG-Infergen
Product, including,
but not limited to, [***] and (ii) [***] of PEG Infergen Product.
For avoidance
of doubt, PEG Know-How as it relates to manufacturing, shall only
include [***]
PEG-Infergen Products, and shall not include [***]
1.34
"PEG PATENT" shall mean [***]
1.35
"PEG PROGRAM" shall mean a program of collaborative development by
the
Parties of a PEG-Infergen Product (if any such program is agreed to
by the
Parties pursuant to Section 3.2).
1.36
"PEG-INFERGEN PRODUCT" shall mean a pharmaceutical composition
containing as its active ingredient [***]
1.37
"PHASE III CLINICAL TRIAL" means a clinical trial (or set of
clinical
trials) of a pharmaceutical product on sufficient numbers of
patients which, if
the defined end-points are met, are designed or intended to file
for Regulatory
Approval on the basis thereof.
1.38
"PHASE IV CLINICAL TRIAL" shall mean a pharmaceutical product
support
clinical trial of a pharmaceutical product commenced after receipt
of Regulatory
Approval in the country where such trial is being conducted.
1.39
"PLANNING PERIOD DATE" shall have the meaning assigned such
term
pursuant to Section 3.2.
1.40
"REGULATORY APPROVAL" shall mean any approvals (including
supplements,
amendments, pre- and post-approvals and price approvals),
licenses,
registrations or authorizations of any national, supra-national
regional, state
or local regulatory agency, department, bureau, commission, council
or other
governmental entity, necessary for the distribution, use or sale of
a Licensed
Product in a regulatory jurisdiction. Regulatory Approval shall not
include any
[***]
1.41
"REGULATORY AUTHORITY" shall mean the FDA or any counterpart of
the
FDA outside the United States.
1.42
"ROYALTY" OR ROYALTIES" shall mean those amounts payable as
royalties
by InterMune to Amgen pursuant to Sections 6.4 and 6.7(a) of this
Agreement.
1.43
"SUBLICENSEE" shall mean a sublicensee of InterMune under
InterMune's
rights pursuant to Section 2.2, 2.3 and 2.4, the sublicense to whom
is permitted
pursuant to Section 2.5.
1.44
"SUPPLY TERMS" shall mean the terms and conditions set forth in
Exhibit F.
1.45
"TERM" shall mean the term of this Agreement.
1.46
"TERRITORY" shall mean the United States and Canada, and the
possessions and territories of each such country.
1.47
"THIRD PARTY" shall mean any entity other than Amgen or InterMune
or
an Affiliate of either of them.
1.48
"TRADEMARK" shall mean any trade name, service mark, logo or
trademark
(whether or not registered) together with all goodwill associated
therewith, and
any renewals, extensions or modifications thereto.
***Confidential Treatment Requested
4
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1.49
"VALID CLAIM" shall mean (i) an unexpired claim of an issued
patent
within the Amgen Patents that has not been found to be
unpatentable, invalid or
unenforceable by a court or other authority in the country of the
patent, from
which decision no appeal is taken or can be taken; or (ii) a claim
of a pending
application within the Amgen Patents, which application claims a
first priority
no more than [***] prior to the date upon which pendency is
determined.
ARTICLE 2
LICENSES; EXCLUSIVITY; TRADEMARKS
2.1
TECHNOLOGY OWNERSHIP. Except for items (1) and (2) listed in
the
definition of Amgen Know-How, Amgen shall retain sole right and
interest,
subject only to the licenses granted in Section 2.2, 2.3 and 2.4 of
this
Agreement, to the Amgen Technology.
2.2
PATENT LICENSE TO INTERMUNE.
(A) Subject to the terms and conditions of this Agreement,
Amgen
hereby grants to InterMune an exclusive (even as to Amgen) license,
with
the
right to grant sublicenses (subject to InterMune's compliance
with
Section 2.5 of this Agreement), under the Amgen Patents to [***]
Licensed
Products in the Territory.
(B) Subject to the terms and conditions of this Agreement,
Amgen
hereby grants to InterMune an exclusive (even as to Amgen)
sublicense,
without the right to grant sublicenses, under the Existing License
Patents
to
[***] Infergen in the Territory. Except as expressly set forth
herein,
Amgen does not grant InterMune any other rights with respect to
the
Existing License or to Existing License Patents.
(C) Subject to the terms and conditions of this Agreement,
Amgen
hereby grants to InterMune an exclusive license (even as to Amgen),
under
the
PEG Patent, to [***] pegylated Licensed Products.
(D) Subject to the terms and conditions of this Agreement,
Amgen
hereby grants to InterMune an exclusive [***] license (even as to
Amgen),
under PEG Know-How and Patents claiming PEG Know-How, to [***]
pegylated
Licensed Products.
2.3
TRADEMARK AND COPYRIGHT LICENSES TO INTERMUNE.
(A) Amgen hereby grants to InterMune an exclusive [***] license,
with
the
right to grant sublicenses (subject to InterMune's compliance
with
Section 2.5 of this Agreement), under the entire right, title and
interest
in
and to the Amgen Trademarks, to use and display the Amgen
Trademarks in
connection with Licensed Products in the Territory. InterMune shall
have
the
right to select for and use and display with Licensed Products
such
Trademarks as it desires, consistent with any reasonable quality
standards
which Amgen may prescribe for use and display of the Amgen
Trademarks.
(B) Amgen hereby grants to InterMune an exclusive [***] license
under
Amgen's entire right, title and interest in any copyrights in
Infergen-specific promotional materials existing on or before the
Effective
Date, with the right to grant sublicenses (subject to
InterMune's
compliance with Section 2.5 of this Agreement), to reproduce,
distribute
copies of, prepare derivative works of and publicly perform and
display
such
promotional materials in connection with Licensed Products in
the
Territory.
2.4
KNOW-HOW LICENSE TO INTERMUNE. Subject to the terms and conditions
of
this Agreement, Amgen grants InterMune a [***], exclusive license
under the
Amgen Know-How to use the Amgen Know-How for the sole purposes of
[***] Licensed
Products in the Territory.
2.5
SUBLICENSES. Subject to Amgen's prior written approval in each
instance, InterMune may grant sublicenses to Third Parties under
Sections 2.2,
2.3 and 2.4. Notwithstanding the sublicensing of all or part of
InterMune's
rights and obligations hereunder, InterMune shall remain
responsible for the
full and complete performance of all of InterMune's obligations and
duties under
this Agreement. There shall be
***Confidential Treatment Requested
5
<PAGE>
no presumption that Amgen will provide its approval for InterMune
to grant a
sublicense to any Third Party, however Amgen shall not unreasonably
withhold its
consent.
2.6
SUBLICENSED TECHNOLOGY. Amgen shall timely perform and discharge
its
obligations under the Existing License during the Term and shall
not permit any
action to be taken or event to occur, in each case, within Amgen's
reasonable
control, which would give Existing Licensor the right to terminate
Existing
License. InterMune agrees that the rights granted under this
Agreement are
subject to, and agrees to be bound by, all the terms and conditions
required of
sublicensees under the Existing License.
6
<PAGE>
2.7
EXCLUSIVITY.
(A) Except as explicitly permitted pursuant to this Agreement,
Amgen
shall not use, develop, import, promote, sell, or offer for sale
Licensed
Products for use within the Territory.
(B) Amgen shall not [***] a Directly Competitive Product in the
Territory, and shall not [***] take such actions during the Term;
provided,
however, that the foregoing
prohibition shall be subject to Amgen's rights
pursuant to Section 13.6.
2.8
RETAINED RIGHTS. Notwithstanding the exclusive license granted
InterMune pursuant to Section 2.2, Amgen retains the
non-transferable,
non-exclusive right under the Amgen Patents and Amgen Know-How to
[***];
provided, however, that, except as authorized under Section 12.2(b)
Amgen shall
not publish the [***], to the extent [***] of the [***] in [***]
nothing shall
prohibit Amgen or its Affiliates from fulfilling its obligations or
exercising
its rights in this Agreement or with regard to Licensed Products
outside the
Territory.
2.9
IMPORT. The term "import" or "importing" whenever used in this
agreement shall not permit InterMune to conduct any activities
outside the
Territory outside the Territory regarding Licensed Product without
the express
written consent of the Other Licensees.
2.10
COVENANT. Amgen hereby covenants that it and its Affiliates,
assignees, and licensees ("Covenantors") shall not sue InterMune,
its Affiliates
and Sublicensees for infringement of any Patent owned or Controlled
by any
Covenantor, or under which any Covenantor has the right to sue
infringers, in
each case during the Term [***]
ARTICLE 3
DEVELOPMENT
3.1
ONGOING CLINICAL TRIALS. As of the Effective Date, Amgen is
conducting
the Ongoing Clinical Trials in the Territory. As soon as is
reasonably practical
after the Effective date, Amgen will assign (to the extent
assignable) and
transfer its clinical trial contracts covering the Ongoing Clinical
Trials to
InterMune. Amgen shall make reasonable efforts to complete such
assignments
within [***] days after the Effective Date and transfer to
InterMune any data
from the Ongoing Clinical Trials that Amgen possesses as of such
date. To the
extent that Amgen is still conducting the Ongoing Clinical Trials
during such
[***] day transition period, Amgen shall comply with all applicable
laws and
regulations, and regulations of the Regulatory Authorities having
jurisdiction
in the Territory in Amgen's conduct of the Ongoing Clinical Trials,
shall keep
InterMune promptly informed of any inquiries of such Regulatory
Authorities
regarding the Ongoing Clinical Trials, shall provide InterMune with
drafts of
all proposed correspondence with any such Regulatory Authority
regarding any
Ongoing Clinical Trial and permit InterMune to be present at any
meeting with
such a Regulatory Authority regarding any Ongoing Clinical Trial.
InterMune
shall reimburse Amgen for all Ongoing Clinical Trial expenses
incurred by Amgen
after the Effective Date.
3.2
PEG-INFERGEN PRODUCTS. InterMune shall have a period of [***] days
to
[***] and whether it desires to have Amgen provide [***] (as
defined in the Code
of Federal Regulations, as may be amended from time to time) for
the [***] The
Parties recognize that Amgen's expertise with Infergen may be
particularly
applicable to the preclinical development of any PEG-Infergen
Product. Within
[***] days after the end of such [***] day period, if InterMune
notifies Amgen
in writing that InterMune wishes to negotiate with Amgen what
development
activities Amgen would carry out with respect to such PEG-Infergen
Product and
commercially reasonable terms upon which Amgen would carry out such
[***] then
Amgen and InterMune shall negotiate in good faith such activities
and terms for
a period of no less than [***] The end of such [***] day period
shall be
referred to as the "Planning Period Date". The Parties have agreed
that such
commercially reasonable terms for the development of PEG-Infergen
would include
(i) InterMune funding any such development work by Amgen at a rate
equal to
[***] and (ii) all PEG Know How and Patents claiming PEG
***Confidential Treatment Requested
7
<PAGE>
Know-How, which shall be included in the Amgen Technology and
therefore subject
to the licenses of Article 2 of this Agreement.
3.3
DEVELOPMENT EFFORTS. Beginning reasonably promptly after [***]
InterMune shall commence using Commercially Reasonable Efforts to
develop and
seek Regulatory Approval for (in due course) a PEG-Infergen Product
in the
regulatory jurisdictions of the Territory.
3.4
AMGEN INTERIM ACTIVITIES. As InterMune evaluates the business
opportunity for PEG-Infergen Products, Amgen will undertake the
following
preparatory activities to enable InterMune to better evaluate the
possibility of
conducting a collaborative PEG Program with Amgen:
(A) Amgen will [***] with a [***] and provide InterMune with
written
notice of such accomplishment.
(B) Amgen will prepare and provide to InterMune a written [***]
work
plan
detailing activities [***] as part of a PEG Program and
associated
anticipated schedules and costs. Any such plan shall include a
description
of
actions (and associated timings and costs) for Amgen to develop
and
supply InterMune with quantities of GMP-compliant PEG-Infergen
sufficient
to
commence Phase I Clinical Trials thereof. Such a plan shall be
referred
to
herein as a "[***] Work Plan."
Amgen's actions as permitted by this Section 3.4 shall not be
deemed to
bind InterMune to proceed with a PEG Program in collaboration with
Amgen.
3.5
DEVELOPMENT DATA. [***] InterMune shall provide Amgen with
written
summaries of all pre-clinical and clinical data generated by
InterMune with
respect to Infergen (such summaries, the "Development Summaries").
All such
Development Summaries shall be considered Confidential Information
of InterMune
and Amgen may share it with its Other Licensees under appropriate
obligations of
confidentiality and non-use commensurate with those contained
herein. Upon any
Other Licensee's request, InterMune will [***] in such detail as
shall be
reasonably necessary to allow [***] outside the Territory.
3.6
DEVELOPMENT ACTIVITIES IN TERRITORY.
(A) InterMune may collaborate or consult with researchers and
investigators and contract for pre-clinical studies without regard
to
whether such research, investigators and studies are inside or
outside of
the
Territory and without obtaining permission from any Other Licensee,
but
in
no event will InterMune conduct clinical trials with any
Licensed
Product outside the Territory without advance written consent from
the
Other Licensee in whose territory outside the Territory InterMune
wishes to
conduct such clinical trials.
(B) Amgen and any Other Licensee may collaborate or consult
with
researchers and investigators and contract for pre-clinical studies
without
regard to whether such research, investigators and studies are
inside or
outside of the Territory and without obtaining permission from
InterMune,
but
in no event will Amgen or any Other Licensee conduct clinical
trials in
the
Territory with any Licensed Product without advance written
consent
from
InterMune.
ARTICLE 4
REGULATORY
4.1
GENERAL. As of the Effective Date, Amgen owns in its own name
Regulatory Approvals for Infergen in each country of the Territory.
Exhibit D
contains a complete list of such Regulatory Approvals existing as
of the
Effective Date. Subject to Amgen's rights of reference as described
below in
Section 4.3 and Amgen's other rights pursuant to such Section,
Amgen hereby
assigns to InterMune Amgen's entire right, title and interest in
and to all
Regulatory Approvals and Drug Approval Applications for Infergen in
the
Territory to InterMune. [***] after the Effective Date, Amgen shall
notify
Regulatory Authorities in the Territory of, and as soon as is
reasonably
practicable thereafter take all actions reasonably necessary to
effect or
evidence, the transfer of such Regulatory Approvals to InterMune.
In light of
such assignment
***Confidential Treatment Requested
8
<PAGE>
and transfer during the time period when Amgen will be
transitioning the Ongoing
Clinical Trials to InterMune, the Parties will [***] to make
appropriate
arrangements in accordance with law to allow for Amgen continue to
conduct the
Ongoing Clinical Trials under Amgen's IND until the transition of
the Ongoing
Clinical Trials to InterMune is complete. For the avoidance of
doubt, the
transfer of such Regulatory Approvals shall not be effective to
transfer to
InterMune ownership of, [***] any manufacturing trade secret
disclosed therein,
including without limitation, [***]
4.2
ADDITIONAL REGULATORY FILINGS. InterMune shall have the exclusive
right
to file, and will own in its own name, any additional Drug Approval
Applications
for Licensed Products in the Territory, including without
limitation any filings
relating to label expansions for Infergen.
4.3
INTERMUNE ACCESS TO AMGEN REGULATORY DATA.
(A) REGULATORY DATA AS OF THE EFFECTIVE DATE. Amgen will, as soon
as
is
reasonably practicable after the Effective Date, provide
InterMune
originals of the BLA and Canadian equivalent for Infergen in the
United
States and Canada, respectively, and all supplements to either of
the
foregoing; provided, however that Amgen shall be entitled to redact
any
trade secret information relating to products other than Licensed
Products
and
any manufacturing trade secrets proprietary to Amgen (other than
the
[***] for Infergen). Amgen has provided InterMune with a list
of
correspondence between Amgen and the FDA regarding Infergen for
the
approximately two (2) years prior to the Effective Date and shall
provide
InterMune with reasonable access to the correspondence referenced
in such
list, and to other
correspondence between Amgen and Regulatory Authorities
having jurisdiction in the Territory, upon the request of
InterMune.
(B) REGULATORY DATA GENERATED AFTER THE EFFECTIVE DATE. During
the
Term, Amgen will provide to InterMune all regulatory data owned
or
Controlled by Amgen regarding any Licensed Product and necessary
for
marketing or making regulatory filings for Licensed Products in
the
Territory as it becomes available. Such data shall be data
generated in the
Ongoing Clinical Trials (including adverse events encountered in
the
Ongoing Clinical Trials). Except for the information contained in
the CMC
section of Amgen's BLA filings for Infergen, Amgen shall have
no
obligation, for any reason or under any circumstance, to provide
InterMune
with
any information regarding Amgen's manufacturing facility or any
information pertaining to the manufacture of Licensed Products
(including,
without limitation, [***]).
(C)
AMGEN USE OF INFORMATION. Amgen shall have the right to review,
a
right of access, a right of reference and the right to use and
incorporate
all
Amgen Know-How outside the Territory or to satisfy Amgen's
obligations
in
the Territory hereunder or to any Other Licensee [***] The Parties
shall
discuss, as soon as practicable after the Effective Date, the form
in which
the
Parties shall exchange information pursuant to this Section 4.3
and
Section 4.4.
(D) LEGALLY REQUIRED ACCESS. Notwithstanding anything to the
contrary
in
this Agreement, InterMune shall have the right to receive from
Amgen,
and
Amgen shall provide to InterMune, any regulatory data or
information
(including without limitation manufacturing information) to
which
InterMune, as the holder of any Regulatory Approval in the
Territory, is
required by law, rule, regulation or a Regulatory Authority
having
jurisdiction in the Territory, is required to have access, but
shall only
be
entitled to use such regulatory data or information to the
extent
required by such law, rule, regulation or Regulatory Authority.
4.4
ADVERSE EVENT REPORTING; CUSTOMER COMPLAINTS.
(A) After the Effective Date, InterMune shall be responsible for
the
adverse experience and safety reporting for the Licensed Product
in
compliance with the requirements of the U.S. Food, Drug and
Cosmetic Act,
21
USC Section 321 et seq. and the regulations promulgated thereunder
and
the
equivalent regulations in the Territory; provided that Amgen
shall
provide interim adverse experience and safety reporting services
for
Infergen on InterMune's behalf for a period of [***] after the
Effective
Date. Amgen shall, as soon as practicable following of the
Effective Date,
provide InterMune with a
***Confidential Treatment Requested
9
<PAGE>
summary of the information relating to the investigation and
reporting of
adverse experiences regarding Infergen and all information
submitted to
Regulatory Authorities in Amgen's BLA for Infergen and any BLA
supplements
relevant to the safe use of Infergen. If Amgen receives any
customer
complaints regarding the marketing or distribution of Infergen in
the
Territory more than [***] after the Effective Date, it shall
promptly refer
such
complaint to InterMune for handling.
(B) To enable InterMune to satisfy its reporting obligations to
the
Regulatory Authorities having jurisdiction in the Territory, Amgen
shall
require each of its Other Licensees to disclose to Amgen and to
allow Amgen
to
disclose to InterMune all information relating to adverse
events
encountered by or on behalf of such Other Licensee in connection
with any
Licensed Products.
(C) InterMune shall reasonably promptly disclose to Amgen, and
permit
Amgen to disclose to Other Licensees all information relating to
adverse
events encountered by or on behalf of InterMune in connection with
the
Licensed Products.
4.5
COMMUNICATIONS. Except as may be required by law, requested by
InterMune or any Regulatory Authority having jurisdiction in the
Territory, and
except as to issues regarding the manufacture of Licensed Products
in the
Territory, Amgen shall not communicate regarding any Licensed
Product with any
Regulatory Authority having jurisdiction in the Territory unless
requested to do
so by InterMune. Amgen will keep InterMune informed of any such
required
communications. Amgen will reasonably cooperate with InterMune to
make any
communications regarding manufacture of any Licensed Product by
Amgen for supply
to InterMune, with the Regulatory Authorities having jurisdiction
in the
Territory; provided that Amgen shall have no obligation, [***] to
provide
InterMune with any information regarding [***] (including, without
limitation,
[***]). For so long as Amgen is supplying InterMune with Infergen
hereunder,
Amgen shall have the right to be present at all meetings and
telephone calls
with the Regulatory Authorities having jurisdiction in the
Territory at which
[***] is to be discussed.
4.6
APPLICATIONS FOR REGULATORY EXCLUSIVITY. The Parties recognize
that
exclusivity rights granted or provided for under regulatory laws of
the
countries of the Territory may be commercially significant to
Licensed Products.
To the extent permitted by law, InterMune shall have the exclusive
right (even
as to Amgen) to file for, request and maintain any regulatory
exclusivity rights
for Licensed Products in the Territory, including without
limitation regulatory
exclusivity rights based upon an orphan drug designation of a
Licensed Product,
and to conduct and prosecute any proceedings or actions to enforce
such
regulatory exclusivity rights, and Amgen shall reasonably cooperate
with
InterMune in such actions at InterMune's expense.
4.7
RECALLS AND VOLUNTARY WITHDRAWALS. The Parties shall exchange
their
internal standard operating procedures as to product recalls
("SOPs") reasonably
promptly after the Effective Date. If either Party becomes aware of
information
about quantities of Licensed Product supplied by Amgen to InterMune
indicating
that such quantities of Licensed Product may not conform to the
specifications
for such product then in effect pursuant to the Supply Terms, or
that there are
potential adulteration, misbranding and/or other issues regarding
safety or
effectiveness, it shall promptly so notify the other Party. The
Parties will
meet to discuss such circumstances and to consider appropriate
courses of
action, which courses of action with respect to each recall shall
be consistent
with the internal SOP of the Party having the right to control such
recall
pursuant to this Section 4.7. InterMune shall have the right to
control, and
shall bear all costs associated with, a recall of the Licensed
Product in the
Territory. If [***] shall [***] not to [***] in the [***] shall
have the [***]
at [***] As between Amgen and InterMune, Amgen shall control, at
its sole
expense, all recalls of Licensed Product outside the Territory.
InterMune and
Amgen shall each maintain complete and accurate records of any
recall it has the
right to control pursuant to this Section 4.7 for such periods as
may be
required by legal requirements, but in any event for no less than
three (3)
years.
4.8
SAFETY AND CLINICAL DATABASE. Within sixty (60) days after the
Effective Date, Amgen shall transfer to InterMune Amgen's safety
and clinical
database relating to Infergen and existing on the Effective
Date.
***Confidential Treatment Requested
10
<PAGE>
ARTICLE
5
COMMERCIALIZATION
5.1
PRICING. InterMune shall determine in its sole discretion the
pricing,
discounting policy and other commercial terms relating to Licensed
Products in
the Territory.
5.2
DILIGENCE.
(A) InterMune shall use its Commercially Reasonable Efforts to
Commercialize Infergen in the Territory during the Term.
(B) Beginning promptly after the receipt of Regulatory Approval for
a
first PEG-Infergen Product in each country of the Territory,
InterMune
shall use its Commercially Reasonable Efforts to Commercialize
a
PEG-Infergen Product in such country.
5.3
REPORTS. InterMune shall provide Amgen with detailed written
[***]
reports concerning its efforts regarding development and
Commercialization of
the Licensed Products in the Territory. The information contained
in such
reports shall be deemed to be InterMune's Confidential Information.
InterMune
shall, at Amgen's request, promptly meet with Amgen no less
frequently than
[***] to discuss the [***] reports and InterMune's progress
regarding
development and Commercialization of the Licensed Products in the
Territory.
5.4
AMGEN TRANSITION ASSISTANCE.
(A) During the period commencing on the Effective Date and
ending
[***] Amgen shall provide (i) reasonable assistance to InterMune
in
notifying Amgen's distributors and customers as of the Effective
Date of
InterMune's license to Commercialize and further develop the
Licensed
Product; and (ii) [***] on InterMune's behalf.
(B) Until [***] after the Effective Date, Amgen shall provide
reasonable assistance to InterMune to enable it to assume its
responsibilities pursuant to Section 5.6.
(C) For a period of up to [***] after the Effective Date, Amgen
shall
provide InterMune, at mutually agreed times and locations, with
reasonable
access to and assistance from those of Amgen's Infergen
marketing
personnel, as of the Effective Date, selected by Amgen to
transition the
marketing and sales force training knowledge and materials to
InterMune.
Such
assistance would include, without limitation, meeting with
InterMune's
marketing and sales personnel to educate them regarding Infergen
and the
existing marketing arrangements that Amgen had in place for
Infergen as of
the
Effective Date.
5.5
CHANGE OF PROMOTIONAL MATERIAL. Promptly after the Effective Date
and
subject to applicable regulatory requirements and Regulatory
Approvals,
InterMune, at its own expense, shall prepare all advertising and
promotional
materials for any Licensed Product to identify InterMune (or its
distributors)
as the marketer of the Licensed Product, in such form as InterMune
shall
determine. As soon as practicable after the Effective Date,
InterMune, at its
own expense, shall make such changes in the package insert,
Licensed Product
labeling and packaging as may be required to reflect InterMune as
the marketer
of the Licensed Product, including making all required filings in
connection
therewith including without limitation filings with the Regulatory
Authorities
having jurisdiction in the Territory. Promptly after the Effective
Date, Amgen
shall file with Regulatory Authorities in the Territory a notice
that InterMune
is the marketer and distributor of the Licensed Product in the
United States. To
the extent that Regulatory Authorities in the Territory request
additional
information or meetings regarding InterMune's responsibilities as
marketer and
distributor of the Licensed Product in the Territory, Amgen and
InterMune shall
cooperate with each other, and coordinate a response.
5.6
MEDICAL AND OTHER INQUIRIES. On the Effective Date, InterMune
shall
assume all responsibility for all correspondence and communication
with
physicians and other health care professionals and customers in the
United
States and any other countries in the Territory where Amgen had
this
responsibility relating
***Confidential Treatment Requested
11
<PAGE>
to the Licensed Product. InterMune shall keep such records and make
such reports
as shall be reasonably necessary to document such communications in
compliance
with all applicable regulatory requirements. After the Effective
Date, Amgen
shall refer all questions relating to the Licensed Product raised
by health care
professionals and customers to InterMune for its response.
5.7
TRADE RETURNS; REIMBURSEMENTS. Amgen shall bear all costs and
expenses
related to all returns, charge backs and rebates for units of
Licensed Products
sold in the Territory prior to or on the Effective Date. InterMune
shall bear
all costs and expenses related to all returns, charge backs and
rebates for
units of Licensed Products sold after the Effective Date. [***]
shall bear all
costs and expenses related to Medicaid reimbursements for the
Licensed Product
[***] [***] shall bear all costs and expenses related to Medicaid
reimbursements
for the Licensed Product [***] If Amgen receives any [***] it shall
promptly
refer such [***] to InterMune for handling. If InterMune receives
any [***]
InterMune shall promptly refer such [***] to Amgen for
handling.
5.8
DISTRIBUTION AGREEMENTS. Amgen has [***] of all outstanding
material
contracts, agreements or arrangements between Amgen and any Third
Party in the
Territory (including governme
