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
TABLE OF CONTENTS
PAGE
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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
i
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
ii
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
iii
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 Xxx
Xxxxx Xxxxxx Xxxxx, Xxxxxxxx Xxxx, XX 00000-0000 ("Amgen") and INTERMUNE, INC.,
a Delaware corporation having its principal place of business at 0000 Xxxxxxxx
Xxxx, Xxxxx 000, Xxxxxxxxxx, XX 00000-0000 ("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.
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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.
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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
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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 xxxx, logo or trademark
(whether or not registered) together with all goodwill associated therewith, and
any renewals, extensions or modifications thereto.
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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
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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.
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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 xxx 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 xxx 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
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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
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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
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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.
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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
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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 government agencies, health maintenance organizations and
all other buyers of Licensed Product, other than wholesalers) relating to the
sale of the Licensed Product (collectively, "Distribution Agreements"). On the
Effective Date, InterMune shall assume Amgen's obligations under the
Distribution Agreements, to the extent such Distribution Agreements are
assignable by their terms and to the extent (i) pertaining to time periods
subsequent to the Effective Date and (ii) not arising on or before the Effective
Date. To the extent any Distribution Agreement is not freely assignable, Amgen
shall use reasonable efforts to seek the consent of the applicable
Distributor(s) to assign such Distribution Agreement to InterMune and, if and
when so assigned, InterMune shall assume Amgen's obligations under such
Distribution Agreement to the extent (i) pertaining to a time period subsequent
to the date such Distribution Agreement is assigned to InterMune, and (ii) not
arising on or before such date.
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ARTICLE 6
COMPENSATION
6.1 LICENSE FEE.
(A) Prior to the Effective Date InterMune paid Amgen one million
Dollars ($1,000,000) in consideration of exclusive negotiations that led to
the execution of this Agreement.
(B) Within five (5) business days after the Effective Date, InterMune
shall pay Amgen a license fee of twenty million Dollars ($20,000,000) in
cash by wire transfer of immediately available funds into an account
designated by Amgen. This license fee shall be nonrefundable and
noncreditable against Royalties due Amgen pursuant to Section 6.3 and any
other fees, milestone payments or other payments due Amgen under this
Agreement.
6.2 AMGEN PERFORMANCE MILESTONES.
(A) Within [***] days after [***] InterMune shall pay Amgen a
performance milestone payment equal to [***]
(B) Within [***] days after the time Amgen provides InterMune with
written notice, in accordance with Section [***] that Amgen has [***] that
is [***] InterMune shall pay Amgen a performance milestone payment equal to
[***]
(C) Within [***] business days after the time Amgen provides InterMune
with a [***] to do pursuant to [***] InterMune shall pay Amgen a
performance milestone payment equal to [***]
6.3 PRODUCT MILESTONES.
(A) InterMune shall pay to Amgen milestone payments as set forth in
this Section 6.3(a) within [***] days after the first achievement of the
corresponding milestone for a PEG-Infergen Product that is pegylated [***]
(an "Amgen PEG-Infergen Product") that is [***] to be [***]. No milestone
payment shall be payable more than once, no matter how many times achieved
by a single [***] or multiple [***] Such milestone payments shall be
nonrefundable and noncreditable against royalties payable pursuant to
Sections 6.4 and 6.7, and any other fees, milestone payments or other
payments due Amgen under this Agreement.
MILESTONE PAYMENT
MILESTONE EVENT AMOUNT
--------------- -----------------
1. [***] [***]
2. [***] [***]
3. [***] [***]
4. [***] [***]
5. [***] [***]
-----
TOTAL [***]
(B) InterMune shall pay to Amgen milestone payments as set forth in
this Section 6.3(b) within [***] days after the first achievement of the
corresponding milestone for an Amgen PEG-Infergen Product [***] No
milestone payment shall be payable more than once, no matter how many times
achieved by a single [***] or multiple [***] Such milestone payments shall
be nonrefundable and
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noncreditable against Royalties payable pursuant to Sections 6.4 and 6.7,
and any other fees, milestone payments or other payments due Amgen under
this Agreement.
MILESTONE PAYMENT
MILESTONE EVENT AMOUNT
--------------- -----------------
1. [***] [***]
2. [***] [***]
3. [***] [***]
4. [***] [***]
5. [***] [***]
-----
TOTAL [***]
(C) [***] MILESTONE PAYMENTS. If any Milestone Event [***] to Amgen
hereunder of any previously listed Milestone Payment described in Sections
6.3(a) or (b), respectively, with respect to such Licensed Product, then
[***] all previously listed Milestone Payments described in Sections 6.3(a)
or (b) with respect to such Licensed Product [***]
6.4 ROYALTIES. Subject to the other terms and conditions of this Agreement,
InterMune shall pay Amgen a royalty equal to [***] percent [***] (the "Royalty")
of Net Sales of each Licensed Product sold during each calendar quarter by
InterMune and its Affiliates and Sublicensees. For purposes of calculating such
royalty, Net Sales of any Combination Product shall be determined as provided
pursuant to Section 6.6.
6.5 TERM OF ROYALTIES. Amgen's right to receive Royalties under Section 6.4
shall expire, on a Licensed Product-by-Licensed Product basis, in each country
of the Territory upon the [***]
6.6 COMBINATION PRODUCTS. Net Sales of any Licensed Product sold by or on
behalf of InterMune, its Affiliates and/or its Sublicensees as part of a product
which consists of the Licensed Product in combination with one or more Active
Components ("Combination Product"), for purposes of determining the Royalty
payable to Amgen under Section 6.4, shall be calculated as follows:
(A) In the event each of the Active Components and Licensed Product
are sold separately, the Net Sales for the purpose of determining Royalties
on sales of the Combination Product shall be calculated by multiplying Net
Sales of such Combination Product by the fraction A/(A+B) where A is the
price to Third Parties of the Licensed Product component of the Combination
Product when sold separately, and B is the price to Third Party end users
of the Active Component(s) of the Combination Product when sold separately.
(B) If, on a country-by-country basis, the Active Component(s) in the
Combination Product are not sold separately in such country, but the
Licensed Product is sold separately in such country, Net Sales for the
purpose of determining Royalties of the Combination Product shall be
calculated by multiplying Net Sales of such Combination Product by the
fraction A/C where A is the price to Third Party end users of the Licensed
Product when sold separately, and C is the price to Third Parties of the
Combination Product. If, on a country-by-country basis, the Licensed
Product is not sold separately in such country, Net Sales for the purposes
of determining royalties of the Combination Product shall be D/(D+E), where
D is the fair market value of the portion of the Combination Product that
contains the Licensed Product and E is the fair market value of the portion
of the Combination Product containing the Active Component(s) included in
such Combination Product, as such fair market values are determined in good
faith by the Parties.
6.7 EXISTING LICENSE ROYALTIES.
(A) Amgen is, as of the Effective Date, a party to the Existing
License, and pursuant to the Existing License Amgen owes the Existing
Licensor a royalty of [***] percent [***] on Net Sales of Infergen by Amgen
and its sublicensees under its licenses pursuant to the Existing License.
In addition
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to Royalties payable by InterMune pursuant to Section 6.4, InterMune shall
pay to Amgen a royalty equal to [***] percent [***] of Net Sales of
Infergen sold during each calendar quarter by InterMune and its Affiliates.
Such obligation to pay Amgen a royalty beyond that due pursuant to Section
6.4 shall expire upon the expiration or termination of Amgen's obligation
to pay a royalty for Infergen pursuant to the Existing License in respect
of Net Sales of Infergen by InterMune and its Affiliates. Without limiting
Amgen's obligations pursuant to Section 2.6, including its obligations
thereunder with respect to the Existing License, Amgen shall timely make
all payments due to the Existing Licensor under the Existing License in
respect of InterMune's and its Affiliates' Net Sales of Infergen. Amgen
shall promptly notify InterMune of any notice of default or breach that it
receives in relation to the Existing License. If the Existing License
terminates or expires in such a way that Amgen does not have a right to
sublicense under any intellectual property licensed under the Existing
License that relates to Infergen, Amgen shall promptly notify InterMune.
6.8 ROYALTY PAYMENTS AND REPORTS. All Royalties payable to Amgen under this
Agreement (including Royalties payable to Amgen under Section 6.6(a) in relation
to the Existing License) shall be paid in Dollars within [***] days of the end
of each calendar quarter except as otherwise specifically provided herein. Each
payment of Royalties owing to Amgen shall be accompanied by a statement [***] in
performing such computations and in accordance with GAAP, on a
country-by-country basis, of the amount of gross sales of Licensed Products and
Combination Products, an itemized calculation of Net Sales of each Licensed
Product and Combination Product during such quarter, showing any deductions
provided for in Section 1.30 during such quarter, the amount of aggregate
worldwide gross sales of Licensed Product and Combination Product and Net Sales
during such quarter and on a cumulative basis for the current year and the
amount of Royalty due on Net Sales during such quarter.
6.9 TAXES. Amgen shall be responsible for any and all taxes levied on
account of amounts it receives under this Agreement. If InterMune is required by
law, rule or regulation to withhold taxes from such types of payments due Amgen
hereunder, InterMune will (i) deduct those taxes from the remittable amount,
(ii) pay the taxes to the proper taxing authority, and (iii) send original
copies of all official receipts evidencing such tax obligation together with
written evidence of payment to Amgen within [***] following that payment. In the
event of such withholding, the Parties agree to confer regarding other
reasonable, lawful measures to minimize such withholding.
6.10 BLOCKED CURRENCY. In any country of the Territory where conversion of
the local currency is blocked and such currency cannot be removed from the
country, InterMune shall make payments of any Royalties due hereunder in respect
of Net Sales of Licensed Products in such country in local currency by
depositing such amount to an interest-bearing account in the name of Amgen, in a
bank within such country designated by Amgen.
6.11 FOREIGN EXCHANGE. For the purpose of computing the Net Sales for
Licensed Products sold in a currency other than Dollars, such currency shall be
converted into Dollars at the average rate of exchange for buying funds as
retrieved from the on-line edition of the Wall Street Journal (at
xxxx://xxx.xxxxxxxxxxx.xxx.xxx) for the calendar quarter in which such Net Sales
were made.
6.12 PATENT AND TRADEMARK EXPENSES. InterMune shall reimburse Amgen's costs
(as documented by written invoices for legal services and receipts for filing
and maintenance fees paid) to [***] provided that Amgen shall obtain advance
written consent from InterMune (such consent not to be unreasonably withheld) in
the event any such expenses [***] In the event InterMune does not consent to
reimburse Amgen for any aspect related to [***] Amgen shall not be obligated to
continue any of its activities or to incur any further costs or expenses related
to such aspect.
6.13 LATE PAYMENTS. Any amounts not paid by InterMune when due under this
Agreement shall be subject to interest from and including the date payment is
due through and including the date upon which InterMune has made a wire transfer
of immediately available funds into an account designated by Amgen at a rate
equal to the sum of [***] plus the annual prime rate or successive annual prime
rates of interest
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quoted in the Money Rates section of the on-line edition of the Wall Street
Journal (at xxxx://xxx.xxxxxxxxxxx.xxx.xxx) calculated daily on the basis of a
365-day year.
ARTICLE 7
MANUFACTURE AND SUPPLY
7.1 GENERAL. As of the Effective Date, Amgen has established manufacturing
arrangements for bulk Infergen and finished Infergen. During the Term, Amgen
shall supply to InterMune, and InterMune shall purchase from Amgen, InterMune's
requirements of Licensed Products for Commercialization and any further clinical
development of Infergen in the Territory during the Term, on the Supply Terms
(set forth in Exhibit F). The Parties intend to be bound to a supply
relationship pursuant to the Supply Terms. Each Party hereby agrees that the
Supply Terms are sufficient to govern such relationship and legally binding upon
the Parties.
ARTICLE 8
INTELLECTUAL PROPERTY
8.1 OWNERSHIP OF INVENTIONS. Each Party shall own any inventions made
solely by its employees or agents in their activities hereunder. Inventions
hereunder made jointly by employees or agents of each Party ("Joint Inventions")
shall be owned jointly by the parties. Except to the extent either Party is
restricted by the licenses granted to the other Party and covenants contained
herein, and to the extent permitted by law, each Party shall be entitled to
practice and sublicense Joint Inventions without restriction or an obligation to
account to the other Party. Inventorship shall be determined in accordance with
U.S. patent laws.
8.2 PROSECUTION OF PATENTS.
(A) AMGEN PATENTS. [***] at InterMune's expense to the extent provided
pursuant to Section 6.12 and, to the extent Amgen elects to incur
additional expense for the further prosecution, defend or maintenance of
such Amgen Patents, at Amgen's sole expense. [***] in the jurisdictions of
the Territory. To that end, [***] prior to the date such submission is
proposed to be made, and will [***] shall provide [***] with a copy of each
submission to a patent authority of a jurisdiction within the Territory
regarding any Amgen Patent reasonably promptly after making such filing.
[***] discretion to abandon or not [***] any claim or patent application
within the Amgen Patents anywhere in the Territory, then [***] and shall
provide [***] claim or patent application in the Territory [***] sole
expense.
(B) JOINT PATENTS. With respect to Joint Inventions, the parties shall
select and jointly retain mutually acceptable outside counsel to prosecute
patent applications claiming such Joint Invention (any such patent
application and any patents issuing therefrom a "Joint Patent"). Each party
must consent to any action taken with respect to the Joint Patents (which
consent will not be withheld if withholding consent will, in the opinion of
the retained outside counsel, adversely affect the scope or validity of any
patentable claims) on all such patent applications and patents and all
correspondence to and from such patent offices, including proposed
responses, interferences and oppositions. Each Party shall bear its own
internal costs, and the external costs for outside counsel, filing fees,
etc. shall be borne equally by the Parties, except as provided in the next
sentence of this paragraph. Either Party may disclaim its interest in any
particular Patent covering a Joint Invention, in which case (i) the
disclaiming Party shall assign its ownership interest in such Patent to the
other Party for no additional consideration, (ii) the Party which is then
the sole owner shall be solely responsible for all future costs of such
Patent, and (iii) the disclaiming Party shall have no further rights under
such Patent.
8.3 INFRINGEMENT OF PATENTS AND TRADEMARKS BY THIRD PARTIES.
(A) [***] the Amgen Trademarks and Amgen Patents against Third Parties
and to defend the Amgen Trademarks and Amgen Patents against any challenges
in the Territory. In the event [***] shall
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reasonably assist and cooperate in any such enforcement or defense. [***]
all costs and expenses (including attorneys' fees) incurred by [***] after
the Effective Date to carry out the activities described in the foregoing
two (2) sentences. Recoveries in any actions under this Section 8.3(a)
shall go first to reimburse the Parties' costs and expenses (including
attorneys' fees) for such action and any remainder shall [***]
(B) [***] does not commence an enforcement and/or defense action
pursuant to Section 8.3(a) within [***] in writing or infringement of the
Amgen Patents or Amgen Trademarks in the Territory (or of the filing of a
declaratory judgement action, in the case of defense actions), [***] shall
be entitled to bring and prosecute such an action [***]
(C) JOINT PATENTS. With respect to Third Party Infringement of Joint
Patents other than that Infringement described in Sections 8.5(b) and
8.5(c), the Parties shall confer and take such action, and allocate
expenses and recoveries, in such manner as they shall agree.
8.4 INFRINGEMENT OF THIRD PARTY RIGHTS.
(A) AMGEN AS NAMED PARTY. [***] any action naming Amgen [***] and
claiming the infringement of (i) any Third Party Trademark through the
development or Commercialization of Licensed Product; or (ii) Third Party
Patent through the making, using, selling or having sold Licensed Product.
The Parties shall confer with each other and cooperate during the defense
of any action in which both Amgen and InterMune are named parties.
InterMune shall assist and cooperate with Amgen in the defense of any such
action and if Amgen finds it necessary or desirable to join InterMune as a
party, InterMune shall execute all papers or perform such other acts as may
reasonably be required by Amgen. [***] be entitled to [***] and [***] in
any [***] [***] shall bear all associated costs and expenses (including
attorneys' fees) incurred after the Effective Date and pay all damages and
settlement amounts with respect to the Territory; provided, however, that
[***] shall have no obligation to bear such costs and expenses and pay such
damages and settlement amounts to the extent attributable to [***] Licensed
Products.
(B) INTERMUNE AS NAMED PARTY. InterMune [***] any action which names
InterMune but does not name Amgen and which claims the infringement of (i)
any Third Party Trademark through the development or Commercialization of
Licensed Product; or (ii) Third Party Patent through the using, selling or
having sold Licensed Product. If necessary and at InterMune's expense,
Amgen will assist and cooperate with InterMune in any such defense.
InterMune shall bear all costs and expenses (including attorneys' fees) and
pay all damages and settlement amounts with respect to the Territory,
arising out of or in connection with any such action.
(C) NOTICE. Each Party shall promptly notify the other upon becoming
aware of (i) any Third Party claim or action against InterMune and/or Amgen
for infringement of any Third Party Trademark through the development or
Commercialization of Licensed Product; or Third Party Patent through the
using, selling or having sold Licensed Product; or (ii) any Third Party
infringement of the Amgen Trademarks or Amgen Patents.
(D) SETTLEMENT. Neither Party shall enter into any settlement that
affects the other Party's rights or interests without such other Party's
written consent, which consent shall not be unreasonably withheld or
delayed.
8.5 PATENT MARKING. Licensed Products marketed and sold by InterMune
hereunder shall be marked with appropriate patent numbers or indicia at Amgen's
request to the extent permitted by law in those countries of the Territory in
which such markings have notice value as against infringers of patents.
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ARTICLE 9
REPRESENTATIONS AND WARRANTIES
9.1 MUTUAL REPRESENTATIONS AND WARRANTIES. Each Party hereby represents and
warrants to the other Party as follows:
(A) CORPORATE EXISTENCE AND POWER. As of the Effective Date, it is a
corporation duly organized, validly existing and in good standing under the
laws of the state of Delaware, and has full corporate power and authority
and the legal right to own and operate its property and assets and to carry
on its business as it is now being conducted and as contemplated in this
Agreement, including, without limitation, the right to grant the licenses
granted hereunder.
(B) AUTHORITY AND BINDING AGREEMENT. As of the Effective Date, (a) it
has the corporate power and authority and the legal right to enter into
this Agreement and perform its obligations hereunder; (b) it has taken all
necessary corporate action on its part required to authorize the execution
and delivery of the Agreement and the performance of its obligations
hereunder; and (c) the Agreement has been duly executed and delivered on
behalf of such Party, and constitutes a legal, valid and binding obligation
of such Party that is enforceable against it in accordance with its terms.
(C) NO CONFLICT. As of the Effective Date, the execution, delivery and
performance of this Agreement by such Party does not conflict with, and
would not result in a breach of any agreement, instrument or understanding,
oral or written, to which it is a party or by which it may be bound, nor
violate any material law or regulation of any court, governmental body or
administrative or other agency having jurisdiction over it.
(D) VALIDITY. As of the Effective Date, it is aware of no action,
suit, inquiry or investigation instituted by any Third Party which
questions or threatens the validity of this Agreement.
9.2 MUTUAL COVENANTS. Each Party hereby covenants to the other Party as
follows:
(A) NO MISAPPROPRIATION. It shall not knowingly misappropriate the
trade secret of a Third Party in its activities to develop or Commercialize
Licensed Products.
(B) NO DEBARMENT. In the course of the development and manufacture of
Licensed Products and during the Term, such Party shall not knowingly use
and shall not have knowingly used any employee or consultant who is or has
been debarred by the FDA or Regulatory Authorities, or, to the best of such
Party's knowledge, is or has been the subject of debarment proceedings by
the FDA or Regulatory Authorities.
(C) NO CONFLICT. It will not enter into any agreement with any Third
Party that is in conflict with this Agreement, and will not take any action
that would in any way prevent it from assuming its obligations or granting
the rights granted to the other Party under this Agreement, or that would
otherwise materially conflict with or adversely affect its obligations or
assuming the rights granted to the other Party under this Agreement.
9.3 REPRESENTATIONS, WARRANTIES AND COVENANTS OF INTERMUNE.
(A) EXPERTISE. In entering into this Agreement, InterMune has [***]
(B) DILIGENCE. InterMune covenants to use [***]
(C) COMPLIANCE WITH TRADEMARK SPECIFICATIONS. InterMune covenants to
maintain such reasonable quality standards as [***] in the use of the Amgen
Trademarks to maintain the value of the Amgen Trademarks. During the Term,
InterMune shall provide, at the request of Amgen, representative samples of
items bearing the Amgen Trademarks (including but not limited to Licensed
Product brochures, advertising and other promotional literature).
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(D) COMPLIANCE BY INTERMUNE. InterMune covenants to comply with all
applicable statutes, regulations and guidance of Regulatory Authorities
relating to the Commercialization and further development of the Licensed
Products in each country in the Territory.
9.4 REPRESENTATIONS, WARRANTIES AND COVENANTS OF AMGEN.
(A) REPRESENTATIONS AND WARRANTIES. Amgen represents and warrants to
InterMune as follows:
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[***]
ARTICLE 10
INDEMNIFICATION
10.1 INDEMNIFICATION BY AMGEN. Amgen hereby agrees to defend, hold harmless
and indemnify (collectively "Indemnify") InterMune and its Affiliates, agents,
directors, officers and employees (the "InterMune Indemnitees") from and against
any and all Losses arising out of (i) any Third Party claims resulting directly
or indirectly out of any of Amgen's representations and warranties set forth in
this Agreement being untrue in any material respect when made or any material
breach or material default by Amgen of [***] To be eligible to be so
Indemnified, the InterMune Indemnitees shall provide Amgen with prompt notice of
any claim giving rise to the indemnification obligation pursuant to this Section
10.1 and the exclusive ability to defend (with the reasonable cooperation of
InterMune Indemnitees) and subject to InterMune's right to participate in and
have counsel selected by it participate, at InterMune's expense, in any action
for which InterMune seeks to be Indemnified by Amgen). InterMune shall not
settle any claim for the Loss associated with which any InterMune Indemnitee
seeks to be Indemnified by Amgen, without Amgen's prior written consent,
provided that the Indemnitor shall be relieved of its obligations only if the
failure by the Indemnitee to deliver prompt notice shall have been prejudicial
to its ability to defend such action. Amgen's obligation to Indemnify the
InterMune Indemnitees pursuant to this Section 10.1 shall not apply to the
extent of any Losses (i) that arise from the negligence or intentional
misconduct of any InterMune Indemnitee; (ii) that arise from InterMune's breach
of this Agreement; or (iii) for which InterMune is obligated to Indemnify the
Amgen Indemnitees pursuant to Section 10.2 of this Agreement [***]
10.2 INDEMNIFICATION BY INTERMUNE. InterMune hereby agrees to Indemnify
Amgen and its Affiliates, agents, directors, officers and employees (the "Amgen
Indemnitees") from and against any and all Losses arising from Third Party
claims resulting directly or indirectly from (i) any of InterMune's
representations and warranties set forth in this Agreement (including without
limitation the Supply Terms) being untrue in any material respect when made or
any material breach or material default by InterMune of [***]; or (ii) the
making, having made, using, selling, having sold, offering for sale, or resale
and/or otherwise distributing of Licensed Products by, on behalf of, or under
the authority of InterMune, its Affiliates or any of its Sublicensees. Without
limiting the foregoing, InterMune agrees to Indemnify the Amgen Indemnitees from
any Losses arising from, relating to, or based upon any claim by a Third Party
that a Licensed Product was or is [***] or a Licensed Product caused any death
or personal injury of any kind, including but not limited to any death or
personal injury occurring during the conduct of any clinical trial by, on behalf
of, or under the authority of InterMune, its Affiliates or Sublicensees. To be
eligible to be Indemnified as described above in this Section 10.2, The Amgen
Indemnitees shall provide InterMune with prompt notice of any claim giving rise
to the indemnification obligation pursuant to this Section 10.2 and the
exclusive ability to defend (with the reasonable cooperation of Amgen
Indemnitees and subject to Amgen's right to participate in and have counsel
selected by it participate, at Amgen's expense, in any action for which Amgen
seeks to be Indemnified by InterMune). Amgen shall not settle any claim for the
Loss associated with which any Amgen Indemnitee seeks to be Indemnified by
InterMune, without InterMune's prior written consent, provided that InterMune
shall be relieved of its obligations only if the failure by the Amgen Indemnitee
to deliver prompt notice shall have been prejudicial to its ability to defend
such action. InterMune's obligation to Indemnify the Amgen Indemnitees pursuant
to this Section 10.2 shall not apply to the extent of any Losses (i) that arise
from the negligence or intentional misconduct of any Amgen Indemnitee [***],
(ii) for which Amgen is obligated to Indemnify the InterMune Indemnitees
pursuant to Section 10.1 of this Agreement or the Supply Terms, or (iii) that
arise from any material breach by Amgen of this Agreement [***]
10.3 INSURANCE. Within thirty (30) days of the Effective Date, each Party
shall at its own expense procure and maintain during the Term, insurance
policy/policies, including product liability insurance,
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adequate to cover its obligations hereunder and which are consistent with normal
business practices of prudent companies similarly situated. Amgen may
self-insure and InterMune may, with the Amgen's prior written consent,
self-insure all or part of any such obligation consistent with pharmaceutical
industry practices. Each insurance policy required by, and procured under, this
Section 10.3 by InterMune shall name Amgen as an additional insured. Such
insurance shall not be construed to create a limit of the insuring Party's
liability with respect to its indemnification obligations under this Article 10.
InterMune shall provide Amgen with written evidence of such insurance upon
request. InterMune shall provide Amgen with written notice at least thirty (30)
days prior to the cancellation, non-renewal or material change in such insurance
or self-insurance which materially adversely affects the rights of Amgen
hereunder.
10.4 PRE-EFFECTIVE DATE LOSSES. In connection with this Agreement,
InterMune is not assuming or liable for any Losses resulting from or arising in
connection with the use, marketing, sale, manufacture, distribution or promotion
of any Licensed Product on or prior to the Effective Date. In addition,
InterMune shall not assume or be liable for any Losses whatsoever related to
acts or omissions relating to the Licensed Product occurring prior to the
Effective Date.
10.5 LIMITATION OF LIABILITY. NEITHER PARTY NOR ITS RESPECTIVE AFFILIATES
AND PERMITTED SUBLICENSEES SHALL BE LIABLE FOR SPECIAL, EXEMPLARY, CONSEQUENTIAL
OR PUNITIVE DAMAGES, WHETHER IN CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR
OTHERWISE INCURRED BY THE OTHER PARTY IN CONNECTION WITH THIS AGREEMENT,
INCLUDING BUT NOT LIMITED TO DAMAGES MEASURING LOST PROFITS OR BUSINESS
OPPORTUNITIES. NOTWITHSTANDING THE FOREGOING, AMOUNTS PAID BY A PARTY TO A THIRD
PARTY AS SPECIAL, EXEMPLARY, CONSEQUENTIAL OR PUNITIVE DAMAGES, WHETHER IN
CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR OTHERWISE SHALL BE REIMBURSED SUCH
PARTY BY THE OTHER PARTY TO THE EXTENT SUCH OTHER PARTY IS REQUIRED TO INDEMNIFY
SUCH FIRST PARTY PURSUANT TO THE INDEMNIFICATIONS OF SECTION 10.2 OR 10.1.
ARTICLE 11
RECORDS; ROYALTY AUDIT; PUBLICATIONS
11.1 RECORDS; ROYALTY AUDIT. InterMune shall keep or cause to be kept such
records as are required to determine, in a manner consistent with GAAP, the
accuracy of calculations of all sums or credits due under this Agreement. Such
records shall be retained for no less than a [***] period following the year in
which any payments were made hereunder. Once per calendar year, Amgen shall have
the option to engage, at its own expense, an independent certified public
accountant appointed by Amgen and reasonably acceptable to InterMune, to
examine, in confidence, the records of InterMune as may be necessary to
determine, with respect to any calendar year, the correctness or completeness of
any report or payment required to be made under this Agreement. The report of
such accountant shall be limited to a certificate verifying any report made or
payment submitted by InterMune during such period but may include, in the event
the accountant shall be unable to verify the correctness of any such payment,
information relating to why such payment is unverifiable. All information
contained in any such certificate shall be deemed Confidential Information
hereunder. If any audit performed under this Section 11.1 discloses a variance
of more than [***] from the amount of the original report, Royalty or payment
calculation, InterMune shall bear the full cost of the performance of such
audit.
11.2 PUBLICATIONS" Prior to oral or written presentation or submission for
publication of any data or information relating to Licensed Products, each Party
agrees to provide the other Party the opportunity to review any proposed
presentations or publication at least [***] to their intended submission for
publication for its Confidential Information and each Party shall remove the
Confidential Information of the other Party from any proposed publication or
presentation upon request by such other Party. Amgen will [***] permission from
each [***] relating to Infergen, and shall be [***] to review InterMune's
publications relating
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to Infergen. Any such publications that Amgen discloses to InterMune shall be
treated as Amgen Confidential Information hereunder, and Amgen shall only
disclose any such publications of InterMune's to Other Licensees that agree to
be bound by confidentiality and non-use obligations commensurate with those
contained herein.
ARTICLE 12
CONFIDENTIALITY
12.1 TREATMENT OF CONFIDENTIAL INFORMATION. The Parties agree that during
the Term, and for a period of five (5) years after this Agreement expires or
terminates, a Party receiving Confidential Information of the other Party shall
(i) maintain in confidence such Confidential Information to the same extent such
Party maintains its own proprietary industrial information of similar kind and
value (but at a minimum each Party shall use commercially reasonable efforts to
maintain Confidential Information in confidence); (ii) not disclose such
Confidential Information to any Third Party without prior written consent of the
disclosing Party, except for disclosures to its licensees, sublicensees and
commercial partners for Licensed Products who agree to be bound by obligations
of non-disclosure and non-use at least as stringent as those contained in this
Article 12; and (iii) not use such Confidential Information for any purpose
except those purposes permitted by this Agreement Amgen shall not knowingly
disclose to InterMune any Third Party information or Know-How that Amgen does
not have the legal right to disclose to InterMune and/or has a contractual
obligation not to disclose to InterMune.
12.2 AUTHORIZED DISCLOSURE. Notwithstanding any other provision of this
Agreement, each Party may disclose Confidential Information of the other Party:
(A) 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 a Regulatory
Authority; or
(B) as necessary to file or prosecute those patent applications for
which either Party has the right to assume prosecution or maintenance,
pursuant to Section 8.2(b) of this Agreement (in the case of Amgen's
Confidential Information), prosecute or defend litigation or otherwise
establish rights or enforce obligations under this Agreement, but only to
the extent that any such disclosure is necessary.
provided, however, that the Party required or intending to disclose the other
Party's Confidential Information under Sections 11.2(a) or (b) shall first have
given prompt notice to such other Party to enable it to seek any available
exemptions from or limitations on such disclosure requirement and shall
reasonably cooperate in such efforts by the other Party.
12.3 PUBLICITY; TERMS OF AGREEMENT. The Parties agree that the existence of
and the material terms of this Agreement shall be considered Confidential
Information of both Parties, subject to the special authorized disclosure
provisions set forth below in this Section 12.3 (in lieu of the authorized
disclosure provisions set forth in Section 12.2, to the extent of any conflict)
and without limiting the generality of the definition of Confidential
Information set forth in Section 1.12. The Parties will mutually agree the text
of a press release announcing the execution of this Agreement. Thereafter, if
either Party desires to make a public announcement concerning this Agreement or
the terms hereof, such Party shall give reasonable prior advance notice of the
proposed text of such announcement to the other Party for its prior review and
approval, such approval not to be unreasonably withheld. A Party shall not be
required to seek the permission of the other Party to repeat any information as
to the terms of this Agreement that have already been publicly disclosed by such
Party in accordance with the foregoing or by the other Party. Either Party may
disclose the terms of this Agreement to potential investors who agree to be
bound by obligations of non-disclosure and non-use at least as stringent as
those contained in this Article 12. The Parties acknowledge that Amgen and/or
InterMune may be obligated to file a copy of this Agreement with the U.S.
Securities and Exchange Commission with its next quarterly report on Form 10-Q,
annual report on Form 10-K or current report on Form 8-K or with any
registration statement filed with the U.S. Securities
22
and Exchange Commission (the "SEC") pursuant to the Securities Act of 1933, as
amended and each such Party shall be entitled to make such filing, provided that
it requests confidential treatment of the more sensitive terms hereof to the
extent such confidential treatment reasonably available to the filing Party
under the circumstances then prevailing. In the event of any such filing, the
filing Party will provide the non-filing Party with an advance copy of the
Agreement marked to show provisions for which the filing Party intends to seek
confidential treatment and shall reasonably consider the non-filings Party's
timely comments thereon.
ARTICLE 13
TERM AND TERMINATION
13.1 TERM. This Agreement shall become effective on the Effective Date and
shall remain in effect, unless earlier terminated pursuant to this Article 13,
until the expiration of the later to expire of the last Valid Claim within the
Amgen Patents claiming the use or sale of Licensed Product in the Territory.
13.2 DISCONTINUATION OF COMMERCIALIZATION OR FURTHER DEVELOPMENT. In the
event InterMune shall at any time elect to discontinue all Commercialization and
development activities relating to Licensed Products, InterMune shall notify
Amgen in writing of such election and upon Amgen's receipt of such notification,
this Agreement shall terminate and all licenses under the Amgen Technology
granted to InterMune hereunder shall revert to Amgen.
13.3 TERMINATION FOR DEFAULT.
(A) INTERMUNE. Upon any Default by InterMune under this Agreement
Amgen may notify InterMune of such Default and, in the event such Default
shall be a payment Default, require that InterMune cure such Default within
[***] days of Amgen's notice, or in the event such Default shall be a
Default other than a payment Default, require that InterMune cure such
Default within [***] days of Amgen's notice, or, if such Default (other
than a payment Default) cannot reasonably be cured within such time period,
present a reasonably achievable plan to cure such Default as promptly as is
reasonably practicable under the circumstances. In the event InterMune
shall not have cured the Default at the end of the applicable grace period,
Amgen may terminate this Agreement, and all licenses and assignments
granted hereunder to InterMune, its Affiliates and Sublicensees, shall
revert to Amgen. Upon termination of this Agreement pursuant to this
Section 13.3(a), InterMune shall immediately cease all development and
Commercialization of the Licensed Products, return to Amgen all physical
manifestations of the Amgen Technology, and promptly take all actions
reasonably necessary to effect the transfer to Amgen of all Regulatory
Approvals for Infergen in the Territory (including without limitation by
making such filings as may be required with Regulatory Authorities and
other governmental authorities of the Territory that may be necessary to
effect such transfer).
(B) AMGEN. Upon any Default by Amgen under this Agreement, InterMune
may notify Amgen in writing of such Default and require that Amgen cure
such Default within [***] days, or, if such Default cannot reasonably be
cured within such time period, present a reasonably achievable plan to cure
such Default as promptly as is reasonably practicable under the
circumstances. In the event Amgen shall not have cured the Default at the
end of the [***] grace period, InterMune may [***] or (ii) terminate this
Agreement effective upon a second written notice to Amgen. If Amgen fails
to cure a Default as described in clause (i) of the foregoing sentence
within [***] after such written notice, then any [***] and InterMune shall
be relieved of its obligations pursuant to [***] but the other provisions
of this Agreement (including without limitation Section 6.4) shall remain
in full force and effect.
13.4 LICENSES UPON EXPIRATION. InterMune's licenses pursuant to Sections
2.2, 2.3 and 2.4 shall, upon expiration of this Agreement as provided in Section
13.1 shall automatically convert to being irrevocable and fully paid. Sections
3.1, 3.6, 4.1, 4.2, 4.3, 4.5, 4.6, and 4.8 shall survive expiration of this
Agreement.
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13.5 SURVIVAL. The following provisions shall survive any expiration or
termination of this Agreement for the period of time specified: Articles 10, 11,
12, 13, 14 and 15 and Sections 2.1, 4.4, 4.7, 8.1, 8.2(b), 8.3 and 8.4 (but only
with respect to infringement during the Term), Termination of this Agreement
shall not relieve the Parties of any liability which accrued hereunder prior to
the effective date of such termination nor preclude either Party from pursuing
all rights and remedies it may have hereunder or at law or in equity with
respect to any breach of this Agreement nor prejudice either Party's right to
obtain performance of any obligation. The remedies provided in this Article 13
are not exclusive of any other remedies a Party may have in law or equity,
subject to the Section 13.6 as it applies to the limited category of Defaults
described therein.
13.6 DETERMINATION OF PEG DILIGENCE. If at any time following the Planning
Period Date Amgen believes that InterMune is not meeting its diligence
obligations pursuant to Sections 3.3 or 5.2(b), then Amgen may so notify
InterMune in writing and the Parties will meet to discuss the situation in good
faith. If after such discussions, Amgen continues to believe that InterMune has
not met its diligence obligations pursuant to such Sections, then Amgen may
[***] pursuant to [***] solely to the extent pertaining to [***] and Amgen shall
be entitled to [***] in the Territory [***] provided, however, that if InterMune
disagrees as to whether it has met such diligence obligations, then the matter
shall be resolved in accordance with Article 14, and [***] hereunder shall [***]
until such dispute is resolved (if it is resolved in favor of Amgen).
Notwithstanding anything to the contrary express or implied in this Agreement,
the remedy provided pursuant to this Section 13.6 shall be Amgen's exclusive
remedy (including without limitation to the exclusion of any remedies provided
pursuant to Section 13.2) for InterMune Defaults relating to InterMune's
diligence obligations with respect to a PEG-Infergen Product pursuant to
Sections 3.3 and 5.2(b).
ARTICLE 14
DISPUTE RESOLUTION
14.1 DISPUTES. The Parties recognize that disputes as to certain matters
may from time to time arise during the term of this Agreement which relate to
either Party's rights and/or obligations hereunder. It is the objective of the
Parties to establish procedures to facilitate the resolution of disputes arising
from, concerning or in any way relating to this Agreement in an expedient manner
by mutual cooperation and without resort to litigation. To accomplish this
objective, the Parties agree to follow the procedures set forth in this Section
14.1 if and when a dispute arises under this Agreement. The Parties shall
undertake good faith efforts to resolve any such dispute in good faith. In the
event the Parties shall be unable to resolve such dispute, either Party may, by
written notice to the other Party, have any dispute between the Parties
remaining unresolved after thirty (30) days referred to their respective
executive officers designated below or their designees or successors for
attempted resolution by good faith negotiations within thirty (30) days after
such notice is received. Such designated officers are as follows:
FOR INTERMUNE: INTERMUNE'S GENERAL COUNSEL
FOR AMGEN: AMGEN'S GENERAL COUNSEL
If the designated officers are not able to resolve such dispute within such
thirty (30) day period, either Party may at any time thereafter pursue any legal
or equitable remedy available to it. Notwithstanding the above, either Party
shall be entitled at all times and without delay to seek equitable relief.
14.2 GOVERNING LAW; JUDICIAL RESOLUTION. Resolution of all disputes arising
out of or related to this Agreement or the performance, enforcement, breach or
termination of this Agreement and any remedies relating thereto, shall be
governed by and construed under the substantive laws of the State of California,
as applied to agreements executed and performed entirely in the State of
California by residents of the State of California, without regard to conflicts
of law rules. Any dispute arising under this Agreement shall be submitted to a
state or federal court of competent jurisdiction in California; provided
however, that if
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Amgen is the initiating Party in a dispute, such suit shall be brought in a
state or federal court which has jurisdiction over Burlingame, California; and
if InterMune is the initiating Party in a dispute, such suit shall be brought in
a state or federal court which has jurisdiction over Thousand Oaks, California.
14.3 PATENT AND TRADEMARK DISPUTE RESOLUTION. Any dispute, controversy or
claim relating to the scope, validity, enforceability or infringement of any
patent rights claiming the use or sale of any Licensed Product or of any
Trademark rights relating to Licensed Product shall be submitted to a court of
competent jurisdiction in the Territory in which such patent or trademark rights
were granted or arose. Notwithstanding the foregoing, any dispute, controversy
or claim relating to the scope, validity, enforceability or infringement of any
United States patent rights covering the use or sale of any Licensed Product
shall be submitted to a court of competent jurisdiction in the State of
California. To the extent permitted by law, InterMune agrees that it shall not
dispute the scope, validity, enforceability or infringement of any patent right
outside the United States which claims the use or sale of any Licensed Product.
ARTICLE 15
MISCELLANEOUS
15.1 ENTIRE AGREEMENT; AMENDMENT. This Agreement (including all Exhibits),
the Confidential Disclosure Agreement dated March 9, 2001, and the Exclusive
Dealings Binder dated April 12, 2001 set forth the complete, final and exclusive
agreement and all the covenants, promises, agreements, warranties,
representations, conditions and understandings between the Parties hereto and
supersedes and terminates all prior agreements and understandings between the
Parties. There are no covenants, promises, agreements, warranties,
representations, conditions or understandings, either oral or written, between
the Parties other than as are set forth herein and therein. No subsequent
alteration, amendment, change or addition to this Agreement shall be binding
upon the Parties unless reduced to writing and signed by an authorized officer
of each Party.
15.2 FORCE MAJEURE. Both Parties shall be excused from the performance of
their obligations under this Agreement to the extent that such performance is
prevented by Force Majeure and the nonperforming Party promptly provides notice
of the prevention to the other Party. Such excuse shall be continued so long as
the condition constituting Force Majeure continues and the nonperforming Party
uses reasonable efforts to remove the condition.
15.3 NOTICES. Any notice required or permitted to be given under this
Agreement shall be in writing, shall specifically refer to this Agreement and
shall be deemed to have been sufficiently given for all purposes if mailed by
first class certified or registered mail, postage prepaid, express delivery
service or
25
personally delivered, or if sent by facsimile, electronic transmission
confirmed. Unless otherwise specified in writing, the mailing addresses of the
Parties shall be as described below.
For InterMune: InterMune, Inc.
0000 Xxxxxxxx Xxxx, Xxxxx 000
Xxxxxxxxxx, XX 00000-0000
Facsimile: (000) 000-0000
Attn: General Counsel
With a Copy to: Cooley Godward LLP
Five Palo Alto Square
0000 Xx Xxxxxx Xxxx
Xxxx Xxxx, XX 00000
Fax: (000) 000-0000
Attention: Xxxxxx X. Xxxxx, Esq.
For Amgen: Amgen, Inc.
Xxx Xxxxx Xxxxxx Xxxxx
Xxxxxxxx Xxxx, XX 00000-0000
Fax: (000) 000-0000
Attention: Vice President, Licensing
With a Copy to: Corporate Secretary
15.4 MAINTENANCE OF RECORDS. Each Party shall keep and maintain all records
required by law or regulation with respect to Licensed Products and shall make
copies of such records available to the other Party upon request.
15.5 NO STRICT CONSTRUCTION. This Agreement has been prepared jointly and
shall not be strictly construed against either Party.
15.6 ASSIGNMENT. Neither Party may assign or transfer this Agreement or any
rights or obligations hereunder without the prior written consent of the other,
except that a Party may make such an assignment without the other Party's
consent to Affiliates or to an entity that acquires all or substantially all of
the business of such Party, whether in a merger, consolidation, reorganization,
acquisition, sale or otherwise. This Agreement shall be binding on the
successors and assigns of the assigning Party, and the name of a Party appearing
herein shall be deemed to include the name(s) of such Party's successors and
permitted assigns to the extent necessary to carry out the intent of this
Agreement. Any assignment or attempted assignment by either Party in violation
of the terms of this Section 15.6 shall be null and void and of no legal effect.
15.7 PERFORMANCE BY AFFILIATES. Each of Amgen and InterMune acknowledge
that obligations under this Agreement may be performed by Affiliates of Amgen
and InterMune. Each of Amgen and InterMune guarantee performance of this
Agreement by its Affiliates, notwithstanding any assignment to Affiliates in
accordance with Section 15.6 of this Agreement. Wherever in this Agreement the
Parties delegate responsibility to Affiliates or local operating entities, the
Parties agree that such entities may not make decisions inconsistent with this
Agreement, amend the terms of this Agreement or act contrary to its terms in any
way.
15.8 COUNTERPARTS. This Agreement may be executed in two (2) or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
15.9 SEVERABILITY. If any one or more of the provisions of this Agreement
is held to be invalid or unenforceable by any court of competent jurisdiction
from which no appeal can be or is taken, the provision shall be considered
severed from this Agreement and shall not serve to invalidate any remaining
provisions hereof. The Parties shall make a good faith effort to replace any
invalid or unenforceable
26
provision with a valid and enforceable one such that the objectives contemplated
by the Parties when entering this Agreement may be realized.
15.10 HEADINGS. The headings for each article and section in this Agreement
have been inserted for convenience of reference only and are not intended to
limit or expand on the meaning of the language contained in the particular
article or section.
15.11 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of the
Agreement.
15.12 INDEPENDENT CONTRACTORS. The relationship between InterMune and Amgen
created by this Agreement is one of independent contractors and neither Party
shall have the power or authority to bind or obligate the other except as
expressly set forth in this Agreement.
15.13 USE OF NAME. No right, express or implied, is granted to either Party
by this Agreement to use in any manner any Trademark (except the Amgen
Trademarks as set forth in this Agreement) of the other Party, including the
names "Amgen" and "InterMune", without the prior written consent of the owning
Party, subject to Section 12.3.
15.14 NO WAIVER. Any delay in enforcing a Party's rights under this
Agreement or any waiver as to a particular default or other matter shall not
constitute a waiver of such Party's rights to the future enforcement of its
rights under this Agreement, except with respect to an express written and
signed waiver relating to a particular matter for a particular period of time.
IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate
originals by their duly authorized representatives as of the Effective Date.
AMGEN INC. INTERMUNE, INC.
By: /s/ XXXXX X. XXXXXXX By: /s/ XXXX X. XXXX
--------------------------------- ------------------------------------
Print Name: Xxxxx X. Xxxxxxx Print Name: Xxxx X. Xxxx
Title: Vice President, Licensing Title: Senior Vice President of
Corporate Development
27
EXHIBIT A
AMGEN TRADEMARKS
[***]
INFERGEN
3) Country: US
Appln. Date: 8/13/93
Appln. No.: 74/424795
Reg. Date: 11/7/95
Reg. No.: 1933729
Goods: Pharmaceutical preparation namely interferon for use in the
treatment of viral, neoplastic and autoimmune diseases.
4) Country: Canada
Appln. Date: 9/1/93
Appln. No.: 736130
Reg. Date: 7/21/95
***Confidential Treatment Requested
EXHIBIT B
AMGEN PATENTS AS OF THE EFFECTIVE DATE
[***]
[***]
***Confidential Treatment Requested
EXHIBIT C
PROTEIN SEQUENCE OF [***]
[***]
***Confidential Treatment Requested
EXHIBIT D
REGULATORY APPROVALS FOR INFERGEN AS OF THE EFFECTIVE DATE
UNITED STATES
BLA for HCV treatment--October 6, 1997
Supplement for SingleJect prefilled syringe--January 6, 1999
Supplement for 48-week retreatment--December 22, 1999
Supplement for geriatric language--August 10, 2000
CANADA
BLA for HCV treatment--March 9, 1999
EXHIBIT E
ONGOING CLINICAL TRIALS
[***] [***]
[***] [***]
[***] [***]
***Confidential Treatment Requested
EXHIBIT F
SUPPLY TERMS
- SUPPLY OF INFERGEN.
Amgen shall supply InterMune with InterMune's requirements of Infergen for
development and commercialization in the Licensed Territory in accordance with
the terms of this Exhibit F (the "Supply Terms").
- TERM.
The term of Amgen's supply obligation hereunder shall expire on the earlier
of: (1) the date on which InterMune receives Regulatory Approval to market
Infergen obtained pursuant to a supply agreement [***] Third Party for supply of
Infergen in the Licensed Territory; (2) the date on which InterMune receives
Regulatory Approval to market Infergen manufactured by InterMune or a Third
Party of its choice [***] the effective date of termination of the License and
Commercialization Agreement [***] January 1, 2015.
- EFFECT OF EXPIRATION OR TERMINATION. [***] in addition to
any all other accrued but unpaid payments due Amgen from
InterMune, and Amgen will be obligated to deliver to
InterMune all such firm orders paid for.
- TRANSFER OF MANUFACTURING RIGHTS.
- AMGEN'S THIRD PARTY CONTRACTOR. Amgen may assign or
sublicense any of its rights or obligations under this
Exhibit F to a Third Party contractor, provided that if such
assignment or sublicense is made to a Third Party other than
[***], Amgen shall first obtain InterMune's prior written
consent (not to be unreasonably withheld). Amgen shall
continue to supply Infergen to InterMune in accordance with
the Supply Terms until such time as InterMune receives all
necessary Regulatory Approvals in the Licensed Territory to
market Infergen manufactured by such Third Party contractor.
[***] associated with all work necessary to obtain
Regulatory Approval for InterMune to market Infergen
manufactured by [***] as applicable.
- INTERMUNE AND ITS THIRD PARTY CONTRACTOR. [***] InterMune
will be responsible for paying all costs associated with all
work necessary for InterMune to obtain Regulatory Approval
to market Infergen manufactured by InterMune.
- FORM OF SUPPLY.
Infergen shall be supplied in the following forms only:
- [***]
- [***]
- [***]
- PACKAGING AND LABELING. As of the Effective Date, Amgen has
in its inventory certain quantities of [***] Infergen,
labeled and packaged for commercial sale in the Territory
(the "Amgen Infergen Inventory") from which initial orders
of Infergen placed by InterMune will be filled. When the
Amgen Infergen Inventory is exhausted, InterMune shall
thereafter be responsible for and bear all costs associated
with the design, development, quality release and Regulatory
Approval of all labeling and packaging materials for
Infergen supplied hereunder for commercial sale. InterMune
shall perform its [***] InterMune shall be solely
responsible for labeling and packaging Infergen for clinical
trial use.
- SUPPLY PRICE; THIRD PARTY ROYALTIES; STATEMENTS AND PAYMENTS.
- INFERGEN SUPPLY PRICE
Amgen shall supply Infergen to InterMune at the following prices:
- [***]
***Confidential Treatment Requested
[***]
"Standard Cost" shall mean and include the following cost elements incurred by
Amgen: [***]
- ADDITIONAL WORK. If at InterMune's written request and upon
Amgen's written consent Amgen performs any work or
activities outside the scope of filling purchase orders
placed by InterMune pursuant to paragraph 6.3, or if Amgen
is required by a Regulatory Authority in the Licensed
Territory to perform work not necessitated by or arising
from Amgen's negligence in performing its obligations
hereunder, then [***] Any work performed or to be performed
by Amgen which is necessitated by or arises from Amgen's
negligence in performing its manufacture and supply
obligations hereunder, including but not limited to work
required by a Regulatory Authority in the Licensed Territory
[***]
- THIRD PARTY ROYALTIES. For purposes of this Section 5.3,
"Third Party Payments" shall mean [***]
- [***]
- During the term of Amgen's supply obligation hereunder,
[***]
- STATEMENTS AND PAYMENTS. Amgen shall, on an as delivered
basis, provide InterMune with a statement setting forth
quantities of Infergen delivered, the supply price, the
amount of any Third Party royalties and costs for additional
work, if any. Payments shall be due from InterMune within
[***] following the date of receipt of such shipment at
InterMune's designated facility. Delivery costs shall be
paid directly by InterMune to its designated carrier.
- FORECASTS/ORDERS.
- AMGEN INFERGEN INVENTORY.
Promptly after execution of the License and Commercialization Agreement,
Amgen will provide to InterMune a report showing Amgen's then-current inventory
levels of Amgen Infergen Inventory. InterMune shall specify by binding written
firm purchase order its reasonable requirements of Amgen Infergen Inventory not
later than [***]
- ROLLING FORECASTS.
- InterMune will determine its good faith projected
Infergen supply needs, taking into consideration the
Amgen Infergen Inventory levels, and will deliver the
first rolling forecast for the [***] months prior to
the requested delivery date for InterMune's first firm
order of Infergen to be supplied from Infergen
manufactured for InterMune (i.e., not Amgen Infergen
Inventory). For each quarter of the rolling forecast,
InterMune shall specify the quantity and form per
quarter of its future needs of Infergen. Following
submission of this first forecast, the forecast shall
be amended quarterly (no later than the first day of a
calendar quarter) to: (1) add a forecast for the next
successive calendar quarter for which no forecast has
been submitted and (2) [***] Each quarterly forecast
shall be [***]
- Not later than [***] days after Amgen's receipt of each
rolling forecast, Amgen will confirm in writing that it
can manufacture and supply the quantities specified in
the forecast in the quarters specified therein (the
"Forecast Confirmation"). [***] Promptly thereafter the
Parties shall discuss in good faith [***] If, at any
time after Amgen submits to InterMune its Forecast
Confirmation, Amgen [***] Amgen shall so notify
InterMune in writing and the Parties shall discuss in
good faith such proposed arrangements and other
appropriate means to ensure an uninterrupted supply of
Infergen to InterMune consistent with its forecast.
[***]
- FIRM ORDERS. InterMune shall specify by binding written firm
purchase order its reasonable requirements of Infergen for
each calendar quarter at least [***] in advance of each such
calendar quarter (collectively "Firm Purchase Orders"). Each
Firm Purchase Order shall specify: the quantity [***] and
the delivery date. In no event shall a Firm Purchase Order
be
***Confidential Treatment Requested
more or less than the amount specified for such applicable
quarter in the Rolling Forecast. Amgen will [***] Infergen
to InterMune in response to Firm Purchase Orders. For as
long as Amgen continues to manufacture Infergen [***]
Amgen's manufacturing capacity for Infergen for such period,
provided however that InterMune may order and Amgen shall
supply Infergen in quantities up to [***]
- PRODUCT SPECIFICATIONS; NONCOMPLIANT GOODS; INSPECTIONS.
- CGMP. Infergen supplied by Amgen hereunder will be
manufactured in accordance with current Good Manufacturing
Practices (as defined in the Code of Federal Regulations)
and the manufacturing process approved by the relevant
Regulatory Authorities in the Licensed Territory. Infergen
shall be manufactured by Amgen in a facility approved by
applicable Regulatory Authorities. Amgen shall be
responsible for keeping such facility and the manufacturing
processes for Infergen in compliance with current Good
Manufacturing Practices.
- SHELF LIFE. [***]
- PRODUCT SPECIFICATIONS AND MANUFACTURING PROCESS. Amgen will
supply Infergen which complies with the product
specifications and the manufacturing process approved by the
relevant Regulatory Authorities in the Licensed Territory
(collectively, the "Specifications"). For so long as
InterMune purchases Infergen from Amgen under the terms and
conditions set forth herein, no changes to the
Specifications may be made without each Party's prior
written consent (which may be withheld in either Party's
sole discretion, provided that no consent shall be needed
from InterMune in order for Amgen to make changes (i) as
required by the relevant Regulatory Authorities in the
Licensed Territory or (ii) to comply with current Good
Manufacturing Practices). [***] Amgen shall notify InterMune
in writing of any changes in or to the Specifications,
Amgen's manufacturing facilities or procedures, vendors, raw
materials or capital equipment that will or may require
InterMune to amend the BLA for Infergen or otherwise fulfill
InterMune's regulatory obligations.
- PRODUCT RELEASE. Amgen shall be responsible for the
manufacturer's release of Infergen. Amgen will provide to
InterMune upon release of each lot of Infergen complete and
accurate certificates of analysis, certificates of
compliance, and deviations and their investigations (the
"Disposition Package"). As InterMune may request from time
to time, Amgen will make batch records relating to
fermentation, bulk Infergen, Infergen for fill and finish
manufacturing and packaging available for InterMune's
inspection, which records shall be complete and accurate.
- TESTING AND NONCOMPLIANT GOODS. Amgen and InterMune shall
agree on a mutually acceptable Third Party to conduct
testing of Infergen for compliance with Specifications, and
Amgen and InterMune will each be entitled to a complete copy
of all testing data. InterMune shall have [***] from receipt
of all requested records, in which to (i) review the
Disposition Package, and upon InterMune's request, the
relevant batch records, provided pursuant to Subsection 7.4
above; (ii) test a shipment of Infergen for compliance with
Specifications, and (iii) notify Amgen in writing of any
noncompliant Infergen, including but not limited to Infergen
manufactured using a manufacturing process not approved by
the relevant Regulatory Authority. Amgen shall cooperate
with InterMune in good faith to determine whether such
rejection is justified. [***]
- FINAL PRODUCT LOT RELEASE. [***] shall be solely responsible
for final lot release of Infergen for all uses (including
but not limited to review of the Disposition Package and
batch records, and such testing as [***] may elect to
perform to ensure the final quality assurance and quality
control and conformance of such lots to the lot release
specifications of all applicable Regulatory Authorities).
- INSPECTIONS. In addition to its review of the Disposition
Package pursuant to subsection 7.4 above, InterMune may
visit and inspect and audit, at its own expense, [***] in
each case in so far as such facilities or records relate
solely to the Infergen supplied hereunder. Information
obtained by InterMune in the course of such inspections
shall be treated as Confidential
***Confidential Treatment Requested
Information, provided however that InterMune may disclose
such Confidential Information to the extent necessary to
comply with applicable law or regulations or other
requirements of the relevant Regulatory Authorities in the
Licensed Territory. Inspections conducted hereunder will be
limited in scope to what is reasonably necessary to confirm
that Amgen has complied with current Good Manufacturing
Practices in manufacturing and labeling and packaging
Infergen supplied to InterMune hereunder. InterMune may
conduct inspections no more frequently than [***] InterMune
will coordinate all inspections of manufacturing facilities
relating to Infergen with Amgen and provide Amgen with [***]
Amgen shall respond in writing with an action plan for
corrective and preventative actions [***] Amgen shall
reasonably cooperate with applicable Regulatory Authorities
with respect to inspections.
- KNOW-HOW. Except as expressly set forth in the License and
Commercialization Agreement, Amgen shall have no obligation
to disclose to InterMune, and InterMune shall have no rights
with respect to, any Amgen Know-How, including but not
limited to that pertaining to the Manufacturing Know-How
relating to Infergen; [***]
- DISCLAIMER. OTHER THAN THE EXPRESS WARRANTIES SPECIFICALLY
SET FORTH IN SUBSECTIONS 7.1, 7.2 AND 7.3 ABOVE, AMGEN MAKES
NO REPRESENTATIONS OR WARRANTIES OF ANY KIND AND HEREBY
DISCLAIMS ALL OTHER REPRESENTATIONS AND WARRANTIES OF ANY
KIND WHATSOEVER, EXPRESS OR IMPLIED, WITH RESPECT TO ITS
SUPPLY OF INFERGEN TO INTERMUNE.
- STABILITY. [***]
- SHIPMENT AND DELIVERY. All Infergen supplied by Amgen will be
delivered to [***] InterMune shall be responsible for all
delivery logistics, delivery validation, insurance and compliance
with laws and regulations (including but not limited to those
applicable to the export of each [***] delivery from the United
States to Canada) and all costs associated with any of the
foregoing. [***]
- COMPLIANCE WITH LAWS.
Subject to paragraph 5.2, Amgen shall be responsible for complying with
applicable laws and regulations relating to the manufacture of Infergen supplied
to InterMune hereunder. Amgen has and shall maintain all necessary government
permits, including without limitation, health and safety and environmental
permits necessary for the conduct of the actions it undertakes pursuant to its
supply obligations hereunder.
- BREACH OF SUPPLY OBLIGATION
If Amgen fails to timely supply material quantities of Infergen in
accordance with Firm Purchase Orders (other than by reason of force majeure) or
supplies material quantities of Infergen in material breach of paragraphs 7.1,
7.2, or 7.3, then [***]
- ADDITIONAL AGREEMENTS.
- [***]
- SUPPLY OF LICENSED PRODUCT. This Exhibit F governs
solely the supply of Infergen. The Parties shall
negotiate in good faith a separate supply agreement for
the supply of Licensed Products other than Infergen.
- DEFINITIONS. All capitalized terms not otherwise defined
herein shall have the meaning assigned to them in the
License and Commercialization Agreement.
- FORMULATING KNOW-HOW means Amgen's [***]
- MANUFACTURING KNOW-HOW means any Know-how [***]
- MANUFACTURING PATENTS mean any Patents [***]
- AMGEN MANUFACTURING TECHNOLOGY means Manufacturing
Know-how and Manufacturing Patents.
***Confidential Treatment Requested
