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Exhibit
10.83
Note: Redacted portions have
been marked with [*]. The redacted portions are subject to a
request for confidential treatment that has been filed with the
Securities and Exchange Commission.
License Agreement
By and Between
Amgen Inc.
and
Takeda Pharmaceutical Company
Limited
Dated
February 1,
2008
CONFIDENTIAL
Table of Contents
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1 DEFINITIONS
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1 |
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2 COLLABORATION
SCOPE AND GOVERNANCE
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10 |
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3 GRANT OF
LICENSE
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14 |
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4 DEVELOPMENT AND
REGULATORY ACTIVITIES
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18 |
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5 COMMERCIALIZATION
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25 |
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6 DILIGENT EFFORTS;
DISTRACTING PROGRAMS AND TRANSACTIONS
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27 |
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7 MANUFACTURE AND
SUPPLY
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30 |
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8 PAYMENT
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31 |
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9 INTELLECTUAL
PROPERTY
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36 |
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10 CONFIDENTIALITY AND
PUBLICATIONS
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38 |
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11 REPRESENTATIONS, WARRANTIES
AND COVENANTS
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41 |
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12 LIMITATIONS OF LIABILITY;
INSURANCE
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43 |
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13 INDEMNIFICATION
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43 |
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14 TERM
AND TERMINATION
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45 |
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15 MISCELLANEOUS
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47 |
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| SCHEDULES |
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License
Agreement
Preamble
This License Agreement (this
“Agreement” ) is entered into as of the 1st day
of February, 2008 (the “Effective Date” ) by and
between Amgen Inc., a Delaware corporation having its principal
place of business at One Amgen Center Drive, Thousand Oaks, CA
91320-1799 ( “Amgen” ), and Takeda
Pharmaceutical Company Limited, a Japanese corporation having its
principal place of business at 1-1, Doshomachi 4-Chome, Chuo-ku,
Osaka 540-8645, Japan ( “Licensee” ). Amgen and
Licensee are sometimes referred to herein individually as a
“Party” and collectively as the
“Parties.”
Recitals
WHEREAS, Amgen is a
global biotechnology company that conducts pharmaceutical research,
development, manufacturing and commercialization;
WHEREAS, Licensee is a
global pharmaceutical company that conducts pharmaceutical
research, development, manufacturing and commercialization;
and
WHEREAS, Amgen wishes
to partner with Licensee, and Licensee wishes to partner with
Amgen, in each case with respect to the worldwide development and
commercialization of a product Amgen is developing that is referred
to as AMG706 in the Indications (each as defined below), all in
accordance with the terms and conditions hereof.
NOW, THEREFORE, in
consideration of the mutual promises contained herein, and for
other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, and intending to be legally
bound, the Parties hereto agree as follows:
1 D
EFINITIONS
| 1.1. |
“ Additional Indications ” shall mean, with
respect to Licensed Product, any specific indications other than
the NSCLC Indication that are mutually agreed upon by the Parties
through the Development Committee pursuant to Section 6.6
(Additional Indications). |
| 1.2. |
“Affiliate” shall mean any corporation,
person or other entity which directly or indirectly controls, is
controlled by or is under common control with a Party, for so long
as such control exists. For the purposes of this Section 1.2
(“Affiliate”), “ control ” of a
corporation or other entity shall mean: (i) in the case of any
corporate entity, direct or indirect ownership of more than fifty
percent (50%) of the stock having the right to vote for the
election of directors thereof; or (ii) in the case of any
non-corporate entity, direct or indirect ownership of more than
fifty percent (50%) of the equity or income interest
therein. |
| 1.3. |
“Agreement” shall have the meaning set forth
in the Preamble . |
| 1.4. |
“Amgen” shall have the meaning set forth in
the Preamble. |
| 1.5. |
“Amgen Development Data” shall mean the
preclinical and clinical data generated by or on the behalf of
Amgen or its Affiliates on a worldwide basis in the course of its
preclinical and clinical development of Licensed Product in an
Indication, both before and after [*] of this
Agreement. |
| 1.6. |
“Amgen Indemnitees” shall have the meaning
set forth in Section 13.1 (Indemnity). |
| 1.7. |
“Amgen Territory” shall mean the United
States, Canada and Mexico and their respective territories and
possessions. |
| 1.8. |
“AMG706” shall mean that certain small
molecule known as motesanib diphosphate in clinical development as
of [*]. |
| 1.9. |
“Asia” shall mean the following countries
and their respective territories and possessions: [*] and
[*]. |
| 1.10. |
“Bundle” shall mean the Licensed Product
sold to an end-user together with another pharmaceutical compound
for a single price. |
| 1.11. |
“ [*] Quarter” shall mean a
three-month period beginning on [*]. |
| 1.12. |
“ [*] Year” shall mean a one-year
period beginning on [*] and ending on [*]. |
| 1.13. |
“Change of Control” shall mean, with respect
to Licensee, the occurrence of any of the following events:
[*]. |
| 1.14. |
“Claims” shall have the meaning set forth in
Section 13.1 (Indemnity). |
| 1.15. |
“Collaboration” shall have the meaning set
forth in Section 2.1 (Conduct of the
Collaboration). |
| 1.16. |
“Commercialization Committee” shall mean the
committee established by the Parties to oversee and coordinate the
commercialization of the Licensed Product pursuant to the
Collaboration and shall have the responsibilities set forth in
Section 2.10 (Commercialization Committee). |
| 1.17. |
“Commercialization Costs” shall mean [*].
Commercialization Costs shall not include any of the foregoing
costs in this Section 1.17 with respect to Japan. |
| 1.18. |
“Confidential Information” shall have the
meaning set forth in Section 10.1 (Confidentiality;
Exceptions). |
| 1.19. |
“Contract Interest Rate” shall mean [*] plus
the [*] rate effective for the date [*] as published by The Wall
Street Journal , Eastern U.S. Edition, on the [*] (or, if
unavailable on such date, [*] on which such rate is available), or,
if lower, the maximum rate permitted by Law. |
| 1.20. |
“Control” shall mean, with respect to any
Information or intellectual property, that the applicable Party
owns or has a license to such Information or intellectual property
and has the right to grant to the other Party access to and a
license or sublicense (as applicable) under such Information or
intellectual property as set forth herein without violating the
terms of any agreement with any Third Party as of the time such
Party would first be required hereunder to grant such access and
license or sublicense or, with respect to Japan only, requiring any
payment (whether or not then due and payable) under any agreement
with any Third Party as of the time such Party would first be
required hereunder to grant such access and license or
sublicense. |
| 1.21. |
“Cost of Goods Sold” shall mean the [*].
Cost of Goods Sold shall include [*] such activities. Cost of Goods
Sold shall not include any of the foregoing costs in this
Section 1.21 with respect to Japan. |
| 1.22. |
“Cost of Sales” shall mean the sum of Cost
of Goods Sold and [*]. |
| 1.23. |
“Development Committee” shall mean the
committee established by the Parties to oversee and coordinate the
development of the Licensed Product pursuant to the Collaboration
and shall have the responsibilities set forth in Section 2.9
(Development Committee). |
| 1.24. |
“Development Costs” shall mean [*].
Development Costs shall not include any of the foregoing costs in
this Section 1.24 with respect to Japan. |
| 1.25. |
“Development Plan” shall have the meaning
set forth in Section 2.9.3 (Development Plans). |
| 1.26. |
“Distracting Product” shall mean any
[*]. |
| 1.27. |
“Distracting Product Commercial Conditions”
shall have the meaning set forth in Section 6.3 (Addition of
Distracting Products). |
| 1.28. |
“Distracting Product Expiration Date” shall
have the meaning set forth in Section 6.3 (Addition of
Distracting Products). |
| 1.29. |
“Distracting Program” shall mean the [*] by
either Party of any Distracting Product. |
| 1.30. |
“Distracting Transaction” shall mean any
transaction entered into by a Party or its Affiliate after [*]
whereby a Third Party that is engaged in a Distracting Program
becomes an Affiliate of such Party prior to the Distracting Product
Expiration Date. |
| 1.31. |
“Distracting Transaction Affiliates” shall
mean those entities that are or would become Affiliates of a Party
by virtue of a Distracting Transaction. |
| 1.32. |
“Distracting Transaction Party” shall have
the meaning set forth in Section 6.4 (Distracting
Transactions). |
| 1.33. |
“Divest” shall mean, with respect to any
Distracting Product or Distracting Program, the sale, exclusive
license or other transfer of all of the right, title and interest
in and to the applicable Distracting Product, including technology
and other intellectual property and other assets materially
relating thereto, to an independent Third Party, without the
retention or reservation of any rights, title or interest (other
than solely an economic interest) in or to the applicable
Distracting Product or Distracting Program by the relevant Party or
its Affiliates. |
| 1.34. |
“Effective Date” shall have the meaning set
forth in the Preamble. |
| 1.35. |
“EMEA” shall mean the European Medicines Evaluation
Agency or any successor agency thereof. |
| 1.36. |
“ Europe ” shall mean the following
countries and territories: [*]. |
| 1.37. |
“FDA” shall mean the United States Food and
Drug Administration, and any successor agency thereto. |
| 1.38. |
“Federal Court” shall have the meaning set
forth in Section 15.12 (Jurisdiction and Venue). |
| 1.39. |
“First Commercial Sale” shall mean with
respect to a Party, the first sale of a Licensed Product following
Regulatory Approval by or on the behalf of such Party or any of its
Affiliates or licensees. |
| 1.40. |
“Force Majeure” shall have the meaning set
forth in Section 15.9 (Force Majeure). |
| 1.41. |
“FTE” shall mean the equivalent of the work
of one employee full time for one year (consisting of at least a
total of [*] weeks or [*] hours per year (excluding vacations and
holidays)). Overtime, and work on weekends, holidays and the like
shall not be counted with any multiplier (e.g., time-and-a-half or
double time) toward the number of hours that are used to calculate
the FTE contribution. |
| 1.42. |
“FTE Rate” shall mean [*] per full-time
employee per year (as of [*]), increasing by [*] of the
then-current FTE Rate on [*]. |
| 1.43. |
“GAAP” shall mean either Japanese (with
respect to Licensee) or U.S. (with respect to Amgen) generally
accepted accounting principles, consistently applied, as used by a
Party to record the relevant transaction. |
| 1.44. |
“Governmental Authority” shall mean any
government administrative agency, commission or other governmental
authority, body or instrumentality, or any federal, state, local,
domestic or foreign governmental regulatory body. |
| 1.45. |
“Gross Profit” shall mean Net Sales of
Licensed Product (excluding Net Sales in Japan) less the Cost of
Sales for such Licensed Product, plus any Recoveries. |
| 1.46. |
“Indemnified Party” shall have the meaning
set forth in Section 13.2 (Claim for
Indemnification). |
| 1.47. |
“Indemnifying Party” shall have the meaning
set forth in Section 13.2 (Claim for
Indemnification). |
| 1.48. |
“Indications” shall mean with respect to
each Licensed Product, the treatment, palliation, prevention or
prophylaxis of disease in humans with respect only to (i) the
NSCLC Indication, and (ii) any Additional
Indication. |
| 1.49. |
“Information” shall mean all tangible and
intangible techniques, information, technology, practices, trade
secrets, inventions (whether patentable or not and whether or not
reduced to practice), processes, methods, knowledge, know-how,
conclusions, skill, experience, test data and results (including
pharmacological, toxicological and clinical test data and results),
analytical and quality control data, results or descriptions,
software and algorithms. |
| 1.50. |
“Initiation” of a clinical trial or to
“Initiate” a clinical trial shall mean the first
dosing of a human subject with a Licensed Product in such
trial. |
| 1.51. |
“Joint Loss(es)” shall have the meaning set
forth in Section 13.3 (Joint Losses). |
| 1.52. |
“Joint Patents” shall mean any invention,
patent or patent application jointly owned by the Parties pursuant
to Section 9.1 (Ownership). |
| 1.53. |
“Joint Project Team” shall mean the
committee established by the Parties to coordinate the activities
of the Parties hereunder and to establish and designate
subcommittees as necessary to manage the activities of the Parties
hereunder. |
| 1.54. |
“Law” shall mean, individually and
collectively, any and all laws, ordinances, rules, directives,
administrative circulars and regulations of any kind whatsoever of
any Governmental Authority within the applicable
jurisdiction. |
| 1.55. |
“ Licensed Amgen Know-How ” shall mean
Information Controlled by Amgen (or its Affiliates), as of [*] or
thereafter during the Term, that is reasonably necessary for
Licensee to develop or commercialize a Licensed Product in the
Indications in the Licensee Territory. Licensed Amgen Know-How
shall include Amgen Development Data that is reasonably necessary
for Licensee to develop or commercialize a Licensed Product in the
Indications in the Licensee Territory. Except to the extent
otherwise mutually agreed by the Parties in connection with any
supply arrangement entered into pursuant to Section 7.3
(Commercial Supply), Licensed Amgen Know-How does not include Amgen
manufacturing Information. Licensed Amgen Know-How shall include
Information known to the employees of Amgen K.K., Amgen’s
wholly-owned subsidiary that is being acquired by Licensee, as of
the consummation of the transactions contemplated in that certain
Sale and Purchase Agreement executed concurrently herewith that is
reasonably necessary for Licensee to develop or commercialize a
Licensed Product in the Indications in the Licensee
Territory. |
| 1.56. |
“ Licensed Amgen Patents ” shall mean those
patents and patent applications set forth on the Licensed Amgen
Patents Schedule, as well as any continuation, divisional,
substitution, continuations-in-part, reissue, reexamination,
provisional and converted provisional applications thereof, [*].
For purposes of determining whether a patent application falls
within this definition, a patent application shall be considered
“infringed” if its pending claims would be infringed if
issued as then currently set forth in the patent
application. |
| 1.57. |
“ Licensed Amgen Trademarks ” shall mean any
trademark rights Controlled by Amgen (or its Affiliates) in the
Licensee Territory on or after [*] and corresponding to any
trademarks adopted by Amgen for use with a Licensed Product in an
Indication in the Amgen Territory (not including any corporate or
house marks, and not including any marks to the extent such marks
would conflict with any right of any Third Party inside the
Licensee Territory). |
| 1.58. |
“ Licensed Licensee Know-How ” shall mean
Information Controlled by Licensee (or its Affiliates), as of [*]
or thereafter during the Term, that is reasonably necessary for
Amgen to develop, manufacture or commercialize a Licensed Product
in the Territory in any Indication. Licensed Licensee Know-How
shall include Licensee Development Data that is reasonably
necessary for Amgen to develop, manufacture or commercialize a
Licensed Product in the Territory in any Indication. |
| 1.59. |
“ Licensed Licensee Patents ” shall mean
those patents and patent applications Controlled by Licensee or its
Affiliates (including an interest in a patent or Joint Patent
pursuant to Section 9.1 (Ownership)) that [*]. For purposes of
determining whether a patent application falls within this
definition, a patent application shall be considered
“infringed” if its pending claims would be infringed if
issued as then currently set forth in the patent
application. |
| 1.60. |
“ Licensed Licensee Trademarks ” shall mean
any trademarks adopted by Licensee for use with a Licensed Product
in the Licensee Territory in the Indications (not including any
corporate or house marks or Licensed Amgen Trademarks). |
| 1.61. |
“ Licensed Product ” shall mean any
pharmaceutical composition comprising [*]. |
| 1.62. |
“ Licensee ” shall have the meaning set
forth in the Preamble. |
| 1.63. |
“ Licensee Assumed Item ” shall have the
meaning set forth in Section 9.2.1(ii) (Licensee Secondary
Prosecution). |
| 1.64. |
“ Licensee Development Data ” shall mean the
preclinical and clinical data generated by or on behalf of Licensee
or its Affiliates in the course of its preclinical (if any) and
clinical development of a Licensed Product, on or after
[*]. |
| 1.65. |
“ Licensee Indemnitees ” shall have the
meaning set forth in Section 13.1 (Indemnity). |
| 1.66. |
“Licensee Territory” shall mean the entire
world excluding the Amgen Territory. |
| 1.67. |
“Licensee Territory IP” shall have the
meaning set forth in Section 9.4.1 (In Licensee
Territory). |
| 1.68. |
“Licensee Territory Patents and Trademarks”
shall have the meaning set forth in Section 9.2.1
(i) (Amgen Primary Prosecution). |
| 1.69. |
“ Losses ” shall have the meaning set forth
in Section 13.1 (Indemnity). |
| 1.70. |
“MHLW” shall mean the Japanese Ministry of
Health, Labour and Welfare, and any successor agency
thereto. |
| 1.71. |
“Net Operating Profit” shall mean, with
respect to each Party, such Party’s share of Gross Profit
less such Party’s share of Operating Expenses
. |
| 1.72. |
“Net Sales” shall mean with respect to a
given period, the gross invoiced sales price for a Licensed Product
sold by or on behalf of a Party, its Affiliates or licensees
hereunder to Third Parties (not including such Party’s
Affiliates, unless and to the extent such Affiliate is the end-user
of such a Licensed Product) during such period, less the
total of the following charges or expenses, as determined in
accordance with GAAP: |
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1.72.1. |
Trade, cash, prompt payment and quantity discounts; |
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1.72.2. |
Returns, allowances, rebates, chargebacks and payments to
government agencies; |
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1.72.3. |
Retroactive price reductions; |
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1.72.4. |
Fees paid to distributors, wholesalers, selling agents
(excluding any sales representatives of a Party or any of its
Affiliates), group purchasing organizations and managed care
entities; |
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1.72.5. |
Credits and allowances for product replacement, whether cash or
trade; and |
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1.72.6. |
Non-recoverable sales taxes, excise taxes, tariffs and duties
(excluding taxes when assessed on income derived from
sales); |
in each case, to the extent
related to sales of a Licensed Product in an Indication and
actually given.
| 1.73. |
“NSCLC Indication” shall mean the treatment,
palliation, prevention or prophylaxis of disease in humans with
respect only to non-small cell lung cancer (NSCLC). |
| 1.74. |
“Ongoing Studies” shall mean those clinical
studies that are being undertaken by Amgen as of [*] with respect
to the Licensed Product, including those set forth on the Ongoing
Studies Schedule. |
| 1.75. |
“Operating Expenses” shall mean [*].
Operating Expenses shall include Commercialization Costs and Other
Collaboration Costs. Operating Expenses shall not include any of
the foregoing costs in this Section 1.75 with respect to
Japan. |
| 1.76. |
“Other Collaboration Costs” shall mean [*].
Other Collaboration Costs shall not include any of the foregoing
costs in this Section 1.76 with respect to Japan. |
| 1.77. |
“Party/Parties” shall have the meaning set
forth in the Preamble. |
| 1.78. |
“Patent Matters” shall have the meaning set
forth in Section 9.2.1(i) (Amgen Primary
Prosecution). |
| 1.79. |
“Phase I Trial” shall mean, with
respect to the United States, any human clinical trial, the
principal purpose of which is preliminary determination of safety
in healthy individuals or patients as required under 21 C.F.R.
§312.21(a), or, with respect to a jurisdiction other than the
United States, an equivalent clinical study. |
| 1.80. |
“Phase II Trial” shall mean, with respect to
the United States, any human clinical trial conducted in the
specific patient population with the disease or condition of
interest intended to be studied in a Phase III Trial for the
purposes of preliminary assessment of safety and efficacy in the
indication being studied, and selection of the dose regimen(s) to
be studied in a Phase III Trial, as described under 21 C.F.R.
§312.21(b), and that, if the defined end-points are met, is
sufficient to allow the Initiation of a Phase III Trial in the
indication being studied, or, with respect to a jurisdiction other
than the United States, an equivalent clinical study. |
| 1.81. |
“Phase III Trial” shall mean, with
respect to the United States, any human clinical trial, that, if
the defined end-points are met, is intended to be a pivotal trial
for obtaining Regulatory Approval in the indication being studied
or to otherwise establish safety and efficacy in patients with the
indication being studied for purposes of filing for Regulatory
Approval with the FDA as required under 21 C.F.R.
§312.21(c), or, with respect to a jurisdiction other than the
United States, an equivalent clinical study. |
| 1.82. |
“Prior Agreement” shall have the meaning set
forth in Section 10.4 (Prior Agreement). |
| 1.83. |
“Publishing Party” shall have the meaning
set forth in Section 10.5.2 (Oversight and
Review). |
| 1.84. |
“Reasonably Diligent Efforts” shall mean,
with respect to a Party and a particular Licensed Product, the
application of a level of resources, efforts and urgency to develop
and commercialize such Licensed Product consistent with such
Party’s practices in pursuing the development and
commercialization of its other high-value pharmaceutical products
in light of its characteristic features, target indication,
competitiveness, sales volume and intellectual property situation,
but in no event less than the high professional standards and level
commonly applied by other pharmaceutical companies to their
high-value pharmaceutical products. [*]. |
| 1.85. |
“Recall” means a “recall” or
“market withdrawal” (each as defined per
Section 7.3 of Title 21 (Food and Drugs) of the Code of
Federal Regulations, or, with respect to a jurisdiction other than
the United States, the equivalent regulations of the applicable
Governmental Authority in such jurisdiction) of Licensed Product or
any lots thereof. |
| 1.86. |
“Recoveries” shall mean [*]. Recoveries
shall not include any of the foregoing amounts in this
Section 1.86 with respect to Japan. |
| 1.87. |
“Regulatory Approval” shall mean, with
respect to a country or territory, the product-specific approvals
from a Governmental Authority necessary for the marketing,
distribution and sale of a Licensed Product in such country or
territory. |
| 1.88. |
“Regulatory Filing” shall mean any filing
with any Governmental Authority with respect to the development,
marketing, commercialization or reimbursement of a Licensed
Product. |
| 1.89. |
“Reviewing Party” shall have the meaning set
forth in Section 10.5.2 (Oversight and Review). |
| 1.90. |
“SOPs” shall have the meaning set forth in
Section 4.14 (Recalls). |
| 1.91. |
“SPC” shall mean any patent term extension
or related extension of rights, including supplementary protection
certificates and similar rights. |
| 1.92. |
“State Court” shall have the meaning set
forth in Section 15.12 (Jurisdiction and Venue). |
| 1.93. |
“Steering Committee” shall mean the
committee established by the Parties to oversee and coordinate
their activities hereunder, and to ensure appropriate communication
and oversight by the Parties, as set forth in Section 2.7
(Steering Committee). |
| 1.94. |
“Taxes” shall mean any tax, excise or duty,
other than taxes upon income. |
| 1.95. |
“Term” shall mean the period beginning on
[*] and ending upon the termination of this Agreement pursuant to
Article 14 (Term and Termination). |
| 1.96. |
“Termination Date” shall have the meaning
set forth in Section 14.3 (Effect of Termination). |
| 1.97. |
“Territory” shall mean the entire
world. |
| 1.98. |
“Third Party” shall mean any entity other
than a Party or an Affiliate of a Party. |
| 1.99. |
“Third Party Royalties” shall mean [*].
Third Party Royalties shall not include any of the foregoing
amounts in this Section 1.99 with respect to
Japan. |
| 1.100. |
“Transition Period” shall have the meaning
set forth in Section 14.5 (Transition Period). |
| 1.101. |
“VAT” shall mean any value added
tax. |
2 C OLLABORATION S
COPE AND G
OVERNANCE
| 2.1 |
Conduct of the Collaboration . The Parties shall
cooperate to develop and commercialize the Licensed Product in the
Indications in the Territory, in accordance with the terms and
conditions of this Agreement (the
“Collaboration” ). |
| 2.2 |
Governance . The Collaboration shall be governed by
(i) a Steering Committee, which shall oversee the activities
of the Parties hereunder generally, (ii) a Joint Project Team,
which shall coordinate the activities of the Parties hereunder, and
(iii) subcommittees of the Joint Project Team which shall be
established by the Joint Project Team as necessary to manage the
activities of the Parties hereunder. Two such subcommittees shall
be those of the Development Committee and the Commercialization
Committee, which shall oversee the development and
commercialization of the Licensed Product hereunder, respectively.
The Steering Committee, the Joint Project Team, the Development
Committee and the Commercialization Committee shall be formed
promptly following [*]. |
| 2.3 |
Membership . Unless otherwise mutually agreed by the
Parties, the Joint Project Team, the Development Committee and the
Commercialization Committee shall each be comprised of [*] members
appointed by Amgen and [*] members appointed by Licensee. Each
committee shall be led by [*] co-chairs, [*] appointed by each of
the Parties. Unless otherwise mutually agreed by the Parties, the
Steering Committee shall be comprised of [*] members appointed by
Amgen and [*] member appointed by Licensee. The Joint Project Team
shall have the right to delegate any of its responsibilities to one
or more subcommittees as it determines appropriate. |
| 2.4 |
Replacement of Members . Each Party shall have the right
to replace its committee members or co-chairs by written notice to
the other Party. In the event any committee member or co-chair
becomes unwilling or unable to fulfill his or her duties hereunder,
the Party that appointed such member shall promptly appoint a
replacement by written notice to the other Party. |
| 2.5 |
Input from other Personnel . Any committee member shall
have the right to solicit input or assistance from any other
personnel of the Party that appointed such member. |
| 2.6 |
No Authority to Amend or Modify . Notwithstanding
anything herein to the contrary, no committee shall have any
authority to amend, modify or waive compliance with this
Agreement. |
| 2.7 |
Steering Committee . The Steering Committee shall be
responsible for overseeing the Parties’ conduct of the
Collaboration generally, and for ensuring an appropriate level of
oversight of the Collaboration. |
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2.7.1. |
Meetings . The Steering Committee shall meet [*] in
person, via teleconference or videoconference or otherwise (with at
least [*] meeting per [*] Year being in person), or as otherwise
agreed by the Parties. Any in-person meetings shall be held on an
alternating basis between Licensee’s and Amgen’s
facilities, unless otherwise agreed by the Parties. As appropriate,
other employee representatives
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of the Parties may attend
Steering Committee meetings as nonvoting participants, but no Third
Party personnel may attend unless otherwise agreed by the Parties.
Each Party may also call for special meetings as reasonably
required to resolve particular matters requested by such Party by
at least [*] days written notice to the co-chair appointed by the
other Party. All Steering Committee meetings must have at least [*]
member appointed by each Party in attendance.
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2.7.2. |
Reporting . The Joint Project Team shall keep the
Steering Committee fully and promptly informed of progress and
results of activities conducted by the Parties hereunder and shall
fully inform the Steering Committee with respect to all relevant
facts and activities reasonably requested by any member thereof
regarding Licensed Product. |
| |
2.7.3. |
Decision Making . The Steering Committee shall make
decisions by consensus. In the event the Steering Committee fails
to reach consensus with respect to any matter that may [*], such
matter shall be [*]. |
| 2.8 |
Joint Project Team . The Joint Project Team shall be
responsible for overseeing and coordinating the overall plans of
the Parties and resolving matters that are otherwise not resolved
within the various subcommittees as may exist hereunder and for
ensuring an appropriate level of communication between the
Parties. |
| |
2.8.1. |
Meetings . The Joint Project Team shall meet [*] in
person, via teleconference or videoconference or otherwise (with at
least [*] meetings per [*] Year being in person), or as otherwise
agreed by the Parties. Any in-person meetings shall be held on an
alternating basis between Licensee’s and Amgen’s
facilities, unless otherwise agreed by the Parties. As appropriate,
other employee representatives of the Parties may attend Joint
Project Team meetings as nonvoting participants, but no Third Party
personnel may attend unless otherwise agreed by the Parties. All
Joint Project Team meetings must have at least [*] member appointed
by each Party in attendance. |
| |
2.8.2. |
Reporting . Each Party, through the members appointed by
it on each subcommittee, shall keep the Joint Project Team fully
and promptly informed of progress and results of activities for
which each subcommittee is responsible. Each Party, through the
members appointed by it on each subcommittee, shall fully inform
the Joint Project Team with respect to all relevant facts and
activities reasonably requested by any member thereof regarding any
Licensed Product. |
| |
2.8.3. |
Decision
Making . With respect to unresolved development matters, the
Joint Project Team shall make decisions by consensus. In the event
the Joint Project Team fails to reach consensus with respect to any
such matter, and the Joint Project Team determines that it is
appropriate to do so, such matter shall be escalated to the
Steering Committee for resolution. With respect to unresolved
commercialization matters, [*] shall make the final determination
with respect to commercialization of Licensed Product in the
Licensee Territory, and [*] shall
|
| |
make the final
determination with respect to commercialization of Licensed Product
in the Amgen Territory.
|
| 2.9 |
Development Committee . With respect to each Licensed
Product, the Development Committee shall be responsible for:
(i) subject to Section 2.9.3 (Development Plans),
reviewing and approving new development plans prior to adoption of
such plans by a Party; (ii) reviewing and approving changes to
development plans (including the AMG706 Development Plan) prior to
adoption of such changes by a Party; (iii) providing for
communication and discussion between the Parties to, as
appropriate, coordinate the development activities of the Parties
and to optimize the efficacy and safety of the development of the
applicable Licensed Product; (iv) reviewing and monitoring the
activities and progress of the Parties against the development
plans, including site enrollment, patient enrollment, progress of
trials and data received; (v) communicating with the
Commercialization Committee regarding the interrelationship between
development activities and potential commercialization; and
(vi) communicating with the Joint Project Team regarding all
of the foregoing. |
| |
2.9.1. |
Meetings . Each Development Committee shall meet [*] in
person, via teleconference or videoconference or otherwise (with at
least [*] meetings per [*] Year being in person), more frequently
as may be required by ongoing development activities, or as
otherwise agreed by the Parties. Any in-person meetings shall be
held on an alternating basis between Licensee’s and
Amgen’s facilities, unless otherwise agreed by the Parties.
As appropriate, other employee representatives of the Parties may
attend Development Committee meetings as nonvoting participants,
but no Third Party personnel may attend unless otherwise agreed by
the Parties. Each Party may also call for special meetings as
reasonably required to resolve particular matters requested by such
Party by at least [*] days written notice to the co-chair appointed
by the other Party. All committee meetings must have at least [*]
member appointed by each Party in attendance. |
| |
2.9.2. |
Reporting . Each Party shall keep the relevant
Development Committee fully and promptly informed of progress and
results of development activities for which it is responsible or
that it is permitted to conduct hereunder through its members on
such Development Committee and as otherwise provided herein,
including by promptly providing copies of all clinical data and
results for Licensed Product as reasonably requested by the other
Party through the Development Committee. Each Party shall fully
inform the applicable Development Committee with respect to all
relevant facts and activities reasonably requested by any member
thereof regarding any Licensed Product development matter. At least
five (5) business days prior to the first meeting of each
Development Committee of each Calendar Quarter, each Party shall
deliver to such Development Committee a written summary of
development activities conducted hereunder and material clinical
data and results received by each such Party since the last such
report, in each case with respect to the applicable Licensed
Product(s). |
| |
2.9.3. |
Development Plans . The development plan and budget for
development of AMG706 for the NSCLC Indication in the Territory and
completion of the
|
| |
Ongoing Studies has been
mutually agreed upon by the Parties as of [*] and is attached
hereto as the Development Plan Schedule (as amended by Agreement of
the Development Committee from time to time, “ Development
Plan ”). Should either Party seek to make changes to an
approved Development Plan, then at least [*] days prior to the next
meeting of the Development Committee, it shall provide the
Development Committee any proposed changes to the previously
approved Development Plan for the Development Committee’s
review and approval (including approval for any Additional
Indication).
|
| |
2.9.4. |
Decision Making. The Development Committee shall make
decisions by consensus. In the event the Development Committee
fails to reach consensus with respect to any matter, such matter
shall be [*]. |
| 2.10 |
Commercialization Committee . The Commercialization
Committee shall be responsible for: (i) reviewing and
approving global commercialization plans (and changes thereto)
prior to adoption of such plans (or changes) by the Parties;
(ii) communicating with the Development Committee regarding
the interrelationship between development activities and potential
commercialization; (iii) reviewing the commercialization
activities of the Parties; (iv) overseeing the trademark and
publication strategies; and (v) communicating with the Joint
Project Team regarding all of the foregoing. |
| |
2.10.1. |
Meetings . The Commercialization Committee shall meet
[*] in person, via teleconference or videoconference or otherwise
(with at least [*] meetings per [*] Year being in person), or as
otherwise agreed by the Parties. Any in-person meetings shall be
held on an alternating basis between Licensee’s and
Amgen’s facilities, unless otherwise agreed by the Parties.
As appropriate, other employee representatives of the Parties may
attend Commercialization Committee meetings as nonvoting
participants, but no Third Party personnel may attend unless
otherwise agreed by the Parties. Each Party may also call for
special meetings as reasonably required to resolve particular
matters requested by such Party by at least [*] days written notice
to the co-chair appointed by the other Party. All committee
meetings must have at least [*] member appointed by each Party in
attendance. |
| |
2.10.2. |
Reporting . Each Party shall keep the Commercialization
Committee fully and promptly informed of progress and results of
commercialization activities in the territory for which it is
responsible or that it is permitted to conduct hereunder through
its members on the Commercialization Committee and as otherwise
provided herein. Each Party shall fully inform the
Commercialization Committee with respect to all relevant facts and
activities reasonably requested by any member thereof regarding any
Licensed Product commercialization matter. At least [*] days prior
to the Commercialization Committee meeting of each [*] Quarter,
each Party shall deliver to the Commercialization Committee a
written summary of commercialization activities conducted hereunder
by each such Party since the last such report. |
| |
2.10.3. |
Commercialization Plans . At least [*] days prior to the
last meeting of the Commercialization Committee of each [*] Year
(or such other time as mutually agreed), each Party shall provide
the Commercialization Committee a copy of its proposed
commercialization plan for the Licensed Product in such
Party’s respective territory under the Collaboration for the
next [*] Year for the Commercialization Committee’s review,
comment and approval (either by Indication or for all Indications
for which it is responsible in such Party’s respective
territory)). In addition, should a Party seek to make material
changes to an approved commercialization plan, then at least [*]
days prior to the next meeting of the Commercialization Committee
it shall provide the Commercialization Committee any proposed
changes to the previously approved commercialization plan for the
Commercialization Committee’s approval. |
| |
2.10.4. |
Decision Making . The Commercialization Committee shall
strive to reach consensus on decisions, taking into account the
views of each committee member. Decisions with respect to
day-to-day commercial operations for which a Party has
responsibility (other than any matter that could reasonably be
expected to adversely affect the other Party’s
commercialization in its territory), shall be made by such Party
and notice thereof shall be submitted to the Commercialization
Committee solely for informational purposes. With respect to any
commercial matter that could reasonably be expected to adversely
affect the other Party’s commercialization of Licensed
Product in such Party’s respective territory, if the
Commercialization Committee fails to reach consensus, such matter
shall be [*]. Notwithstanding the above, with respect to unresolved
matters that could reasonably be expected to adversely affect the
other Party’s commercialization of Licensed Product and that
have been [*], in the event that exigent circumstances require a
Party to take action in the best interests of the Licensed Product
with respect to its territory, such Party shall be allowed to do so
by providing written notice of such decision or action to the
Commercialization Committee. |
3 G RANT
OF L ICENSE
| 3.1 |
Licensed Amgen Patents . Amgen hereby grants Licensee
[*] right and license under the Licensed Amgen Patents during the
Term, subject to the terms and conditions hereof, solely to
research, develop, commercialize, use, import and sell Licensed
Product only in the Indications in the Licensee Territory, except
that Amgen retains non-exclusive rights in the Licensee Territory
to develop, use, commercialize and sell (in accordance with
Section 5.3 (Commercialization in Europe) or as otherwise
agreed by the Commercialization Committee), and manufacture
Licensed Product. Such license to Licensee shall include the right
to sublicense only as set forth in Section 3.4 (Licensee
Sublicensing). Amgen also hereby grants Licensee [*] right and
license under the Licensed Amgen Patents during the Term, subject
to the terms and conditions hereof, solely to develop Licensed
Product only in the Indications in the Amgen Territory. |
| 3.2 |
Licensed
Amgen Know-How . Amgen hereby grants Licensee [*] right and
license during the Term, subject to the terms and conditions
hereof, to utilize the Licensed Amgen
|
| |
Know-How solely for the
purpose of supporting its research, development, commercialization,
use, importation and sale of Licensed Product only in the
Indications in the Licensee Territory, except that Amgen retains
non-exclusive rights in the Licensee Territory to research,
develop, use, import, commercialize and sell (in accordance with
Section 5.3 (Commercialization in Europe) or as otherwise
agreed by the Commercialization Committee), and manufacture
Licensed Product. Such license shall include the right to
sublicense only as set forth in Section 3.4 (Licensee
Sublicensing). Amgen also hereby grants Licensee [*] right and
license during the Term, subject to the terms and conditions
hereof, to utilize the Licensed Amgen Know-How solely for the
purpose of supporting its development of Licensed Product only in
the Indications in the Amgen Territory.
|
| 3.3 |
Licensed Licensee Know-How and Patents . Licensee hereby
grants Amgen [*] right and license, subject to the terms and
conditions hereof, under the Licensed Licensee Know-How and
Licensed Licensee Patents (i) solely for the purpose of the
development, commercialization, manufacture, use, importation and
sale of Licensed Product in the Amgen Territory for all uses,
(ii) solely for the purpose of the development, manufacture,
use and importation of Licensed Product in the Licensee Territory
(excluding Japan during the Term) and for the purpose of
commercialization and sale of Licensed Product in the Licensee
Territory (x) during the Term in accordance with
Section 5.3 (Commercialization in Europe) or as otherwise
agreed by the Commercialization Committee and (y) after the
Term for all uses, and (iii) for performing its obligations
hereunder, including any supply obligations with respect to
Licensed Product. Such license shall include the right to grant
sublicenses to those persons and entities to which Amgen (or its
Affiliate or licensee) is also granting licenses to any Amgen
patent or know-how relating to Licensed Product or the use thereof;
provided, however, that: (a) any sublicensee shall be required
to enter into a written agreement obligating it to maintain the
confidentiality of the Confidential Information of Licensee;
(b) Amgen shall be responsible for any disclosure of the
Confidential Information of Licensee by such sublicensee in
violation of the provisions of Article 10 (Confidentiality and
Publications); (c) no such sublicense shall operate to excuse
Amgen’s compliance with its obligations hereunder; and
(d) Amgen shall be responsible for a breach by such
sublicensee of any such obligations or prohibitions. |
| 3.4 |
Licensee
Sublicensing . Licensee shall have the right to sublicense the
rights granted it hereunder only with Amgen’s prior written
consent, which consent may not be unreasonably withheld or delayed,
except with respect to any of the parties [*] for which Amgen may
withhold or condition its consent in its sole discretion. Any
permitted sublicensee shall be required to enter into a written
agreement obligating it to maintain the confidentiality of the
Confidential Information of Amgen and Licensee shall be responsible
for any disclosure of the Confidential Information of Amgen by such
sublicensee in violation of the provisions of Article 10
(Confidentiality and Publications). In addition, such written
agreement shall require such sublicensee to comply with the
obligations and prohibitions of this Agreement relevant to the
right(s) sublicensed, and Licensee shall be responsible for a
breach by such sublicensee of any such obligations or prohibitions.
No sublicense shall operate to excuse Licensee’s compliance
with its
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obligations hereunder.
Licensee shall have the right to distribute a Licensed Product in
the Licensee Territory through reputable distributors with prior
written notice to Amgen.
|
| 3.5 |
Provision of Know-How . Following [*], the Parties shall
cooperate to establish procedures for the provision of Licensed
Amgen Know-How to Licensee and Licensed Licensee Know-How to Amgen.
During the Term, Amgen shall use reasonable efforts to provide all
material Licensed Amgen Know-How to Licensee, and Licensee shall
use reasonable efforts to provide all material Licensed Licensee
Know-How to Amgen. In any event, each of the Parties shall provide
to the other any Licensed Amgen Know-How or Licensed Licensee
Know-How (respectively) as the other Party shall reasonably
request. Notwithstanding the foregoing, Amgen shall have no
obligation to provide manufacturing information to Licensee (except
as may be expressly agreed to by the Parties pursuant to
Section 7.3 (Commercial Supply)) unless provision of such
information is necessary to develop and commercialize Licensed
Products in accordance with this Agreement and neither Party shall
have an obligation to provide information relating to any product
other than the Licensed Product. |
| |
3.6.1. |
Grant to
Licensee . Amgen hereby grants to Licensee [*] right and
license during the Term, subject to the terms and conditions
hereof, solely to develop, commercialize, use, import and sell
Licensed Product in the Licensee Territory in the Indications under
the same Licensed Amgen Trademarks as used by Amgen for Licensed
Product in such Indications in the Amgen Territory. Such license
shall include the right to sublicense only as set forth in
Section 3.4 (Licensee Sublicensing). The Parties acknowledge
that the use of the Licensed Amgen Trademarks in the Licensee
Territory may have commercial value to Licensee, and that Licensee
shall have the right to commercialize Licensed Product in the
Indications in the Licensee Territory under the same Licensed Amgen
Trademarks as utilized for Licensed Product in such Indications by
Amgen in the Amgen Territory. Should the Parties desire that a
different trademark be used for Indications in the Licensee
Territory, or if additional trademarks to those used in the Amgen
Territory are otherwise required, the Parties shall consult and
agree upon an additional or replacement trademark (or trademarks)
(which additional or replacement trademark(s) shall, as between the
Parties, be owned by Amgen). In addition, if the manufacture of
Licensed Product for Licensee for use in the Licensee Territory
materially varies from the manufacture of Licensed Product for
Amgen or its Affiliates for use in the Amgen Territory, then upon
the request of Amgen, the Parties shall consult and agree upon a
replacement trademark (or trademarks) (which replacement
trademark(s) shall, as between the Parties, be owned by Amgen).
Upon Amgen’s request, Licensee shall include an Amgen
trademark designated by Amgen to Licensee in writing (e.g.,
“Amgen”) on all packaging, labeling, promotional and
marketing materials for the applicable Licensed Product in equal
prominence to those of Licensee in a form and manner approved by
Amgen. Amgen hereby grants Licensee a non-exclusive right and
license, with the right to sublicense only as set forth in
Section 3.4 (Licensee Sublicensing), during the Term, subject
to the terms and conditions hereof, to use
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such Amgen marks solely
for such purpose. Such Amgen marks shall be subject to the quality
control provisions set forth in Section 3.7 (Trademark Quality
Standards). All uses by Licensee of the Licensed Amgen Trademarks
and other Amgen marks permitted hereunder, and all goodwill
associated therewith, shall inure solely to the benefit of
Amgen.
|
| |
3.6.2. |
Grant to Amgen . Licensee hereby grants to Amgen [*]
right and license during the Term to use Licensed Licensee
Trademarks in connection with Amgen’s activities pursuant to
Section 5.3 (Commercialization in Europe) and Section 5.5
(Co-Promotion Rights). All uses by Amgen of the Licensed Licensee
Trademarks, and all goodwill associated therewith, shall inure
solely to the benefit of Licensee. Upon any termination or
expiration of this Agreement, such license shall become paid-up and
perpetual, and shall include the right to use the relevant Licensed
Licensee Trademarks in connection with Licensed Product in all
indications and throughout the Territory unless, at
Licensee’s option, Licensee decides to assign the relevant
Licensed Licensee Trademarks (and the associated goodwill) to Amgen
at no charge. |
| 3.7 |
Trademark Quality Standards . Each Party shall
(i) maintain such reasonable quality standards for the
Licensed Amgen Trademarks (with respect to Licensee) or the
Licensed Licensee Trademarks (with respect to Amgen) at least as
high as the standards it maintains for its own trademarks of a
similar nature and shall comply with the other Party’s
reasonable specifications and usage standards supplied to it in
writing (and as may be updated by written notice from time to
time); (ii) not use any Licensed Amgen Trademark (with respect
to Licensee) or Licensed Licensee Trademark (with respect to Amgen)
in a manner that suggests any connection with any product other
than a Licensed Product or any service; and (iii) not use or
display the Licensed Amgen Trademarks (with respect to Licensee) or
the Licensed Licensee Trademarks (with respect to Amgen) in any
manner that might dilute, tarnish, disparage or reflect adversely
on the other Party or such marks. Prior to using any Licensed Amgen
Trademark (with respect to Licensee) or Licensed Licensee Trademark
(with respect to Amgen), the Parties shall agree upon a guideline
for use of such trademarks, including the review procedure and
timing. From time to time, upon request by a Party, the other Party
shall provide representative specimens of the usage of the Licensed
Amgen Trademarks (with respect to Licensee) or Licensed Licensee
Trademarks (with respect to Amgen) used in the marketing or
promotion of a Licensed Product in order to review such usage.
Amgen shall not seek to register or obtain ownership rights in any
Licensed Licensee Trademark (or confusingly similar trademark) and
Licensee shall not seek to register or obtain ownership rights in
any Licensed Amgen Trademark or any trademark used by Amgen in
connection with Licensed Product in the Amgen Territory in any
indication (or confusingly similar trademark to any of the
foregoing). |
| 3.8 |
Retained
Rights and Limitations . Except as expressly granted in this
Article 3, no rights are granted to Licensee hereunder to Licensed
Amgen Patents, Licensed Amgen Know-How or Licensed Amgen Trademarks
outside the Indications, or outside the Licensee Territory. Except
to the extent expressly set forth in Sections 7.2 (Clinical Supply)
or 7.3 (Commercial Supply), no rights are granted to Licensee
hereunder to make or have made
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a Licensed Product or any
other product. No rights are granted to Licensee hereunder to
import or export a Licensed Product manufactured by Amgen or its
licensee, except as specifically contemplated herein. No rights are
granted herein to Licensee to control the research, development or
commercialization of a Licensed Product in the Amgen Territory
except, with respect to development, as otherwise agreed by the
Parties through the Development Committee and, with respect to
commercialization, as allowed under Section 5.5 (Co-Promotion
Rights). No rights to either Party’s patents, trademarks or
other intellectual property or proprietary rights are granted
pursuant to this Agreement except as expressly set forth herein,
and all other rights are reserved.
|
4 D EVELOPMENT
AND R EGULATORY A
CTIVITIES
| 4.1 |
Collaboration for Development . The Parties shall use
Reasonably Diligent Efforts to develop the Licensed Product in the
NSCLC Indication, and in such Additional Indications as may be
mutually agreed upon by the Parties for the Licensed Product
through the Development Committee, and such development shall be
conducted in accordance with the Development Plan. The Parties
shall also use Reasonably Diligent Efforts to develop Licensed
Product in such other Indications, as may be mutually agreed upon
by the Parties through the Development Committee, and development,
if any, of Licensed Product in any such mutually agreed
Indication(s) shall be conducted in accordance with the
then-current Development Plan approved by the Development Committee
for Licensed Product in such Indication(s). |
| 4.2 |
Preclinical Development in Indications . Licensee shall
not conduct any preclinical research with respect to Licensed
Product without the prior written approval of the Development
Committee. Any such research shall be conducted in accordance with
a research plan to be agreed in writing by the Parties through the
Development Committee. If such research is approved by the
Development Committee, Licensee shall promptly and diligently
conduct such research (itself or through a subcontractor) and shall
keep Amgen updated with respect to such pre-clinical research
activities through the Development Committee, and as may be
requested by Amgen from time to time. |
| |
4.3.1. |
Conduct of
Clinical Trials Outside Japan. Amgen shall have the sole right
and obligation to manage and conduct all aspects of all clinical
trials for the Licensed Product in the NSCLC Indication that have
been Initiated as of [*] in the Territory (excluding Japan) and all
Ongoing Studies. To the extent any of the Ongoing Studies currently
contemplate use of Japanese sites, Licensee shall be obligated to
conduct the Japanese aspects of the Ongoing Studies pursuant to
Amgen’s overall management of such studies. Amgen shall have
the first right, but not the obligation, to manage and conduct all
aspects of all clinical trials for the Licensed Product in the
NSCLC Indication that are Initiated from and after [*] in the
Territory (excluding Japan). Licensee shall have the first right,
but not the obligation, to manage and conduct all aspects of all
clinical trials for the Licensed Product in the first Additional
Indication in the Territory (and shall have the
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obligation to do so in
Japan). For all other Indications, responsibilities between the
Parties shall be decided by the Development Committee.
|
| |
4.3.2. |
Licensee’s Conduct of Clinical Trials in Japan.
Except with respect to Ongoing Studies, Licensee shall have the
sole right and obligation to manage and conduct all aspects of all
clinical trials for the Licensed Product in all Indications in
Japan, including (i) designing study protocols;
(ii) establishing/contracting with clinical trial sites,
investigators and clinical research organizations;
(iii) enrolling clinical trial subjects; (iv) organizing
investigator meetings, scientific meetings, advisory panel
workshops and regulatory meetings; (v) analyzing and
summarizing clinical trial results; (vi) forecasting clinical
manufacturing production requirements; and (vii) reporting on
study design, study outcome, other communications and regulatory
filings to the MHLW. Licensee shall keep the Development Committee
updated with respect to all of its clinical trials in Japan for the
Licensed Product in all Indications. |
| 4.4 |
Regulatory Activities . |
| |
4.4.1. |
Licensee Responsibility. Licensee shall own and be
solely responsible for filing, obtaining and maintaining all
Regulatory Approvals for the Licensed Product in the Indications in
the Licensee Territory and any approval for any product labeling or
promotional materials in the Licensee Territory with respect
thereto; and unless otherwise agreed or required by applicable Law,
all such approvals shall be held in the name of Licensee. Licensee
shall also be responsible for any post-approval activities required
to be conducted by any Governmental Authority in the Licensee
Territory for Licensed Product; provided that any post-marketing
studies not required by the MHLW or any other Governmental
Authority in the Licensee Territory, shall be submitted to and
approved by the Development Committee prior to commencing any such
post-marketing studies (as set forth in Section 4.5 (Voluntary
Post-Marketing Studies)), and in any event, Licensee shall submit a
proposal detailing such post-marketing studies required by any
Governmental Authority in the Licensee Territory to the Development
Committee for review (not approval) and shall keep the Development
Committee apprised of the progress and results thereof. |
| |
4.4.2. |
Amgen
Responsibility. Amgen shall own and be solely responsible for
filing, obtaining and maintaining all Regulatory Approvals for the
Licensed Product in the Indications in the Amgen Territory and any
approval for any product labeling or promotional materials in the
Amgen Territory with respect thereto; and unless otherwise agreed
or required by applicable Law, all such approvals shall be held in
the name of Amgen (or its designee). Amgen shall also be
responsible for any post-approval activities required to be
conducted by any Governmental Authority in the Amgen Territory for
any Licensed Product; provided that any post-marketing studies not
required by the FDA or any other Governmental Authority in the
Amgen Territory, shall be submitted to and approved by the
Development Committee prior to commencing any such post-marketing
studies (as set forth in Section 4.5 (Voluntary Post-Marketing
Studies)), and in any event, Amgen shall
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submit a proposal
detailing such post-marketing studies required by any Governmental
Authority in the Amgen Territory to the Development Committee for
review (not approval) and shall keep the Development Committee
apprised of the progress and results thereof.
|
| 4.5 |
Voluntary Post-Marketing Studies . Should either Party
desire to conduct any post-marketing studies (other than
post-marketing studies required by any Governmental Authority in
such Party’s respective territory under the Collaboration),
such Party shall submit a proposal detailing such post-marketing
studies to the Development Committee for review and approval. The
Development Committee shall give due consideration to any concern
expressed by a Party that the conduct of any such post-marketing
study could reasonably be expected to adversely affect such
Party’s development or commercialization of a Licensed
Product in any Indication. Should the Development Committee approve
any such post-marketing study, the then-current applicable
development plan shall be amended accordingly and the Party
proposing to conduct such post-approval study shall conduct such
study in accordance with the amended development plan and shall
keep the Development Committee apprised of the progress and results
thereof. |
| 4.6 |
Development in Combination . Licensee shall not, without
Amgen’s prior express written consent, conduct any
development of Licensed Product in combination with any other
pharmaceutical product. Amgen reserves the right to develop
Licensed Product in combination with other Amgen products or
product candidates but does not intend to develop a single
pharmaceutical agent containing both Licensed Product and another
pharmaceutical product. If Amgen proposes to conduct development of
Licensed Product in combination with another Amgen product or
product candidate, the Parties shall discuss conducting such
development within the Collaboration. If and only if the Parties do
not agree on conducting such development within the Collaboration,
then Amgen shall have the right to conduct such development outside
the Collaboration at its sole expense. For the avoidance of doubt,
nothing in this Section 4.6 (Development in Combination) is
intended to limit or take away from the exclusive right of Licensee
to sell Licensed Product in the Licensee Territory in accordance
with Sections 3.1 (Licensed Amgen Patents) and 3.2 (Licensed Amgen
Know-How). |
| 4.7 |
Sharing of
Regulatory Filings . Each Party shall disclose to the other
Party a draft copy of any Regulatory Filing for a Licensed Product
in an Indication no less than [*] days prior to filing it with a
Governmental Authority. Each Party shall consider in good faith any
comments made by the other Party with respect to such filings.
Where documents are not in English, each Party shall also provide
an English translation. Amgen shall maintain a centralized database
which contains all clinical trial data accumulated from all
clinical trials of a Licensed Product conducted by, on behalf of,
or with the support of each Party under the Collaboration (in a
computer readable format as reasonably specified by Amgen), and
each Party shall have full access to the database. Upon the request
of either Party, the other Party shall provide a right of reference
to any requested Regulatory Filings or Regulatory Approvals for a
Licensed Product in such Party’s respective territory under
the Collaboration, in each case as reasonably necessary for the
requesting Party’s development or commercialization of such
Licensed Product as permitted
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hereunder (and/or, with
respect to Amgen, as reasonably necessary for the manufacture of
such Licensed Product). Notwithstanding the foregoing,
(i) Amgen shall not be required to provide to Licensee nor to
allow Licensee to access (but shall provide a right of reference as
set forth in Section 4.13 (Amgen Cooperation –
Manufacturing Information) to the extent necessary) to
Amgen’s manufacturing information with respect to a Licensed
Product or any sections of any Regulatory Filing related thereto,
and (ii) neither Party shall have an obligation to provide
information relating to any product other than a Licensed
Product.
|
| 4.8 |
Quality Agreement . Promptly following [*], the quality
assurance departments of Amgen and Licensee shall develop and agree
upon a quality agreement governing the quality and specifications
of clinical Licensed Product to be supplied hereunder (with
commercial product handled separately through the supply agreement
to be entered into pursuant to Section 7.3 (Commercial Supply)
or one or more additional quality agreements) including with
respect to product quality and product complaints (to the extent
not covered in a separate safety agreement entered into pursuant to
Section 4.10 (Safety Agreement)) with respect to the Licensed
Product. The quality agreement will be documented in writing, and
routinely updated by mutual written agreement of the
Parties. |
| 4.9 |
Transfer of Regulatory Filing . Promptly after [*],
Amgen shall transfer to Licensee all Regulatory Filings in Japan
with respect to the Licensed Product. Licensee shall not transfer
title in, fail to maintain or otherwise attempt in any manner to
dispose of any Regulatory Filings or Regulatory Approvals or other
governmental licenses, approvals or certificates for Licensed
Product in Japan without the express prior written approval of
Amgen. Notwithstanding the foregoing, Amgen shall have no
obligation to transfer any Regulatory Filing if effectuating such
transfer may give rise to any material delay in, or make less
likely, the receipt of any Regulatory Approval or might otherwise
adversely affect any such Regulatory Filing. Should any such
transfer be so delayed: (i) Amgen shall take steps reasonably
necessary to provide Licensee the necessary access to such
Regulatory Filing; and (ii) Amgen shall thereafter transfer
such Regulatory Filing at such time as such delay or adverse effect
is no longer likely to occur. |
| 4.10 |
Safety Agreement . Promptly following [*] the safety
departments of Amgen and Licensee shall develop and agree upon
safety data exchange procedures governing the coordination of
collection, investigation, reporting, and exchange of information
concerning adverse events with respect to the Licensed Product
sufficient to permit each Party, its Affiliates, permitted
licensees (including permitted sublicensees) t |
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