Exhibit 10.15
COLLABORATIVE LICENSE AGREEMENT
BETWEEN
DENDREON CORPORATION
AND
KIRIN BREWERY CO., LTD.
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as
amended.
TABLE OF CONTENTS
PAGE
ARTICLE 1 DEFINITIONS....................................................... 2
1.1 "Affiliate"....................................................... 2
1.2 "Controlled"...................................................... 2
1.3 "Dendreon Antigen"................................................ 2
1.4 "Dendreon Improvement"............................................ 2
1.5 "Dendreon Know-How"............................................... 3
1.6 "Dendreon Patents"................................................ 3
1.7 "Dendreon Product"................................................ 3
1.8 "Dendreon Technology"............................................. 3
1.9 "Dendreon Territory".............................................. 3
1.10 "Dendritic Cell".................................................. 3
1.11 "Drug Approval Application"....................................... 4
1.12 "Field"........................................................... 4
1.13 "FTE"............................................................. 4
1.14 "Fully Burdened Manufacturing Costs".............................. 4
1.15 "Information"..................................................... 4
1.16 "Joint Territory"................................................. 4
1.17 "Kirin Antigen"................................................... 4
1.18 "Kirin/Dendreon Term Sheet"....................................... 5
1.19 "Kirin Improvements".............................................. 5
1.20 "Kirin Know-How".................................................. 5
1.21 "Kirin Patents"................................................... 5
1.22 "Kirin Product"................................................... 5
1.23 "Kirin Technology"................................................ 5
1.24 "Kirin Territory"................................................. 5
1.25 "Licensed Dendreon Product"....................................... 6
1.26 "Licensed Kirin Product".......................................... 6
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as
amended.
i
TABLE OF CONTENTS
(CONTINUED)
PAGE
1.27 "Net Revenue"..................................................... 6
1.28 "XXX Xxxxx"....................................................... 6
1.29 "North America"................................................... 6
1.30 "Patent".......................................................... 7
1.31 "Patent Costs".................................................... 7
1.32 "Phase II"........................................................ 7
1.33 "Product"......................................................... 7
1.34 "Reagent"......................................................... 7
1.35 "Reasonable Efforts".............................................. 7
1.36 "Regulatory Approval"............................................. 7
1.37 "Separation Devices".............................................. 8
1.38 "Single Treatment"................................................ 8
1.39 "Sublicensee"..................................................... 8
1.40 "Steering Committee".............................................. 8
1.41 "Third Party Royalties"........................................... 8
1.42 "Third Party"..................................................... 8
ARTICLE 2 LICENSES AND RELATED RIGHTS....................................... 8
2.1 Licenses Granted to Kirin......................................... 8
2.2 Licenses Granted to Dendreon...................................... 10
2.3 Kirin Option to License Dendreon Products......................... 10
2.4 Dendreon Option to License Kirin Products......................... 12
2.5 Notice of Development............................................. 14
2.6 Trademark Rights.................................................. 14
ARTICLE 3 MANAGEMENT........................................................ 17
3.1 The Steering Committee............................................ 17
3.2 Steering Committee Meetings....................................... 18
3.3 Decision-Making and Issue Resolution.............................. 19
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as
amended.
ii
TABLE OF CONTENTS
(CONTINUED)
PAGE
3.4 Research Efforts and Expenses..................................... 19
3.5 Other Research.................................................... 19
ARTICLE 4 DEVELOPMENT AND MARKETING IN THE JOINT TERRITORY.................. 19
4.1 Collaborative Development and Marketing........................... 19
ARTICLE 5 FEES AND ROYALTIES................................................ 20
5.1 Technology Transfer Fee........................................... 20
5.2 Royalties on Sales of Kirin Products.............................. 20
5.3 Royalties on Sales of Licensed Dendreon Products.................. 21
5.4 Royalties on Dendreon Sales of Licensed Kirin Products............ 22
5.5 Kirin Milestone Payments.......................................... 22
5.6 Dendreon Milestone Payments....................................... 22
5.7 Payment of Royalties.............................................. 23
5.8 Royalty Structure and Marketing Strategy.......................... 23
ARTICLE 6 EQUITY INVESTMENT BY KIRIN........................................ 24
6.1 Stock Purchase at IPO............................................. 24
6.2 Put Right......................................................... 24
6.3 No Double Purchase................................................ 25
ARTICLE 7 CONFIDENTIALITY................................................... 25
7.1 Confidentiality; Exceptions....................................... 25
7.2 Authorized Disclosure............................................. 26
7.3 Survival.......................................................... 26
ARTICLE 8 INTELLECTUAL PROPERTY............................................. 26
8.1 Ownership......................................................... 26
8.2 Prosecution and Maintenance of Patents by Dendreon; Abandonment... 26
8.3 Prosecution and Maintenance of Patents by Kirin; Abandonment...... 27
8.4 Defense and Settlement of Third Party Claims...................... 27
8.5 Third Party Royalties............................................. 27
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as
amended.
iii
TABLE OF CONTENTS
(CONTINUED)
PAGE
8.6 Enforcement of Patent Rights...................................... 28
ARTICLE 9 REPRESENTATIONS AND WARRANTIES.................................... 29
9.1 Representations and Warranties.................................... 29
ARTICLE 10 REPORTS, RECORDS AND SAMPLES...................................... 29
10.1 Sharing of Information............................................ 29
10.2 Records of Net Revenue............................................ 30
10.3 Materials......................................................... 30
10.4 Publicity Review.................................................. 30
10.5 Publications...................................................... 30
ARTICLE 11 TERM AND TERMINATION.............................................. 31
11.1 Term.............................................................. 31
11.2 Termination for Breach............................................ 31
11.3 Surviving Rights.................................................. 32
11.4 Non-exclusive Licenses after Expiration........................... 32
ARTICLE 12 INDEMNIFICATION................................................... 32
12.1 Indemnification in Kirin Territory................................ 32
12.2 Indemnification in the Dendreon Territory......................... 33
ARTICLE 13 MISCELLANEOUS..................................................... 33
13.1 Assignment........................................................ 33
13.2 Retained Rights................................................... 33
13.3 Force Majeure..................................................... 33
13.4 Further Actions................................................... 34
13.5 No Trademark Rights............................................... 34
13.6 Notices........................................................... 34
13.7 Dispute Resolution................................................ 35
13.8 Waiver............................................................ 35
13.9 Severability...................................................... 35
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as
amended.
iv
TABLE OF CONTENTS
(CONTINUED)
PAGE
13.10 Ambiguities....................................................... 36
13.11 Entire Agreement.................................................. 36
13.12 Headings.......................................................... 36
[ * ] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and
Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as
amended.
v
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Exhibit 10.15
COLLABORATIVE LICENSE AGREEMENT
This Collaborative License Agreement (the "Agreement") is made and entered
into effective as of December, 1998 (the "Effective Date") by and between
Dendreon Corporation, a Delaware corporation having its principal place of
business at 000 Xxxxx Xxxxxxxx Xxxxxx, Xxxxxxxx Xxxx, Xxxxxxxxxx, X.X.X.
("Dendreon"), and Kirin Brewery Co., Ltd., a corporation organized and existing
under the laws of Japan having its principal place of business at 00-0, Xxxxxxxx
0-xxxxx, Xxxx-xx, Xxxxx, Xxxxx ("Kirin"). Dendreon and Kirin may be referred to
herein collectively as the "Parties" or individually as a "Party."
RECITALS
A. Dendreon has developed and owns certain proprietary technology relating
to the isolation and activation of dendritic and other antigen-presenting cells
with antigens of interest for use in human therapies, and Kirin possesses
research, development and marketing capabilities for pharmaceutical and other
medical products.
B. Kirin desires to obtain from Dendreon a license to such Dendreon
technology to develop and commercialize, in Japan and certain other Asian
countries, activated, including without limitation antigen-activated, dendritic
and other antigen-presenting cell products based on such technology, and an
option to obtain the exclusive license to commercialize in such countries
certain Dendreon antigen-presenting cell products that have or will enter into
clinical development during the term of this Agreement.
C. Dendreon desires to obtain from Kirin an option to obtain the exclusive
license to commercialize in North America any Kirin products that are developed
by Kirin under this Agreement based on the Dendreon technology.
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D. With regard to the research collaboration set forth in the
Kirin/Dendreon Term Sheet, Dendreon and Kirin will enter into a Research and
License Agreement consistent with the Kirin/Dendreon Term Sheet.
E. In addition, Dendreon and Kirin will enter into a Manufacturing and
Supply Agreement consistent with the Kirin/Dendreon Term Sheet, which will
establish the terms and conditions for the Parties' purchase and supply of
certain separation devices, reagents and proprietary antigens.
NOW, THEREFORE, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
The following terms shall have the following meanings as used in this Agreement:
1.1 "Affiliate" means, with respect to a particular Party, a person,
corporation or other entity that, directly or indirectly, through one or more
intermediaries, controls, is controlled by or is under common control with such
Party. For the purposes of this definition, "control" means the direct or
indirect ownership by a Party of at least fifty percent (50%) of the outstanding
voting securities of the controlled entity; provided, that in any country where
the law does not permit foreign equity ownership of at least fifty percent
(50%), then with respect to corporations organized under such country's laws,
"control" shall mean the direct or indirect ownership by a Party of outstanding
voting securities of such corporation at the maximum amount permitted by the law
of such country.
1.2 "Controlled" means, with respect to a particular item, material, or
intellectual property right, that a Party owns or has a license under such item,
material or intellectual property right and has the ability to grant to the
other Party access to and/or a license or sublicense under such item, material
or intellectual property right as provided for herein without violating the
terms of any agreement or other arrangement with, or the rights of, any Third
Party.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
2
1.3 "Dendreon Antigen" means an antigen that is claimed by a patent or
is otherwise covered by intellectual property rights that are Controlled by
Dendreon.
1.4 "Dendreon Improvement" means any improvement to platform
technologies in the Dendreon Know-How that relates to the Field and is made and
Controlled by Dendreon during the Agreement and prior to approval of the first
Kirin Product in Japan, or if later, the termination of the Research Program.
1.5 "Dendreon Know-How" means all Information that (a) is Controlled by
Dendreon on the Effective Date, and (b) relates to Dendritic Cell separation and
enrichment, antigens, antigen engineering for delivery of antigen to Dendritic
Cells, Dendritic Cell activation or loading with antigen and/or infusion of such
activated or loaded Dendritic Cells for use in human therapies, which includes,
without limitation, the Information summarized on Exhibit A, as amended from
time to time by Dendreon.
1.6 "Dendreon Patents" means the Patents and Patent applications that
(a) are Controlled by Dendreon during the term of the Agreement, and (b) claim
an invention in the Dendreon Know-How or Dendreon Improvements. Such Patents
existing as of the Effective Date are listed on Exhibit B, and Dendreon will use
reasonable efforts to amend such Exhibit B from time to time to reflect any
changes.
1.7 "Dendreon Product" means: (a) any therapeutic product comprising
Dendritic Cells that have been activated or loaded with a specific antigen,
engineered antigen or antigen gene, (including without limitation Dendreon
Antigen), for use in human therapy by infusion into a patient, which product has
been developed by Dendreon based on the Dendreon Technology; or (b) any service
provided by or on behalf of Dendreon to a patient that utilizes the Dendreon
Technology and involves isolation or preparation of Dendritic Cells, activation
or loading with specific antigen, engineered antigen or antigen gene, (including
without limitation Dendreon Antigen), and infusion of such activated or antigen
loaded Dendritic Cells into a patient. Further, the Parties may agree in writing
to amend and extend the definition of Dendreon Product as provided in Section
5.8.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
3
1.8 "Dendreon Technology" means the Dendreon Know-How, the Dendreon
Improvements and the Dendreon Patents, either collectively or any part thereof.
1.9 "Dendreon Territory" means all countries of the world and all
territories and possessions thereof, excluding all countries, territories and
possessions within the Kirin Territory and the Joint Territory.
1.10 "Dendritic Cell" means a human dendritic cell or other antigen-
presenting cell or other cells from which dendritic cells can be derived.
1.11 "Drug Approval Application" means an application for Regulatory
Approval required before commercial sale or use of a Product as a drug in a
regulatory jurisdiction.
1.12 "Field" means the discovery, development, manufacture, use and sale
of products that generally utilize Dendritic Cell separation, antigen
engineering, and antigen or antigen gene delivery to Dendritic Cells for use in
human therapies that are based on, comprise, utilize or are derived from the
Dendreon Technology. The foregoing products may have applications for other
human medical uses, and if Kirin demonstrates to Dendreon's reasonable
satisfaction that such other uses exist, then the Parties agree to negotiate in
good faith an amendment to the Agreement that extends the Field to cover such
additional uses, including such additional amendments as may be needed to
properly cover such products for royalty purposes.
1.13 "FTE" means work hours equivalent to the work performed by one full-
time employee working for one year (including normal vacation).
1.14 "Information" means any and all information and data of any kind,
including without limitation techniques, inventions, practices, methods,
knowledge, know-how, skill, experience, test data (including pharmacological,
toxicological and clinical test data), analytical and quality control data,
marketing, cost, sales and manufacturing data and descriptions, compositions,
and assays.
1.15 "Joint Territory" means the countries that are members of the
European Union, as such union is constituted at the applicable time.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
4
1.16 "Kirin Antigen" means an antigen that is claimed by a patent or is
otherwise covered by intellectual property rights that are Controlled by Kirin.
1.17 "Kirin/Dendreon Term Sheet" means that certain Term Sheet executed
by the Parties and dated as of June 30, 1998.
1.18 "Kirin Improvements" means all Information developed by or on behalf
of Kirin that (a) is Controlled by Kirin during the term of the Agreement and
prior to approval of the first Kirin Product in Japan, or if later, the
termination of the Research Program, and (b) comprises improvements or
modifications to platform technologies in the Dendreon Technology or their use.
1.19 "Kirin Know-How" means all Information developed by or Controlled by
or on behalf of Kirin that relates directly to a Kirin Product or its
manufacture or use, but excluding the Kirin Improvements.
1.20 "Kirin Patents" means all Patents and Patent applications that claim
any inventions in the Kirin Improvements or the Kirin Know-How, which Patents
shall be listed on Exhibit C promptly after filing, and Kirin will use
reasonable efforts to amend such Exhibit C from time to time to reflect any
changes.
1.21 "Kirin Product" means: (a) any therapeutic product developed by or
on behalf of Kirin based on, derived from or incorporating the Dendreon
Technology that comprises Dendritic Cells that have been activated or loaded
with a specific antigen, engineered antigen or antigen gene, (including without
limitation a Kirin Antigen), for use in human therapy by infusion into a
patient; or (b) any service provided by or on behalf of Kirin to a patient that
involves isolation or preparation of Dendritic Cells, activation or loading of a
specific antigen, engineered antigen or antigen gene, (including without
limitation a Kirin Antigen), and infusion of such activated or antigen loaded
Dendritic Cells into a patient, wherein such service is based on, utilizes,
comprises or is derived from the Dendreon Technology. The Parties may agree in
writing to amend and extend the definition of Kirin Product as provided in
Section 5.8.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
5
1.22 "Kirin Technology" means the Kirin Improvements, Kirin Know-How and
Kirin Patents, either collectively or any part thereof.
1.23 "Kirin Territory" means Japan, Australia, New Zealand, People's
Republic of China (including Hong Kong and Macao), Taiwan, South Korea, North
Korea, Mongolia, Vietnam, Laos, Cambodia, Thailand, Myanmar, Philippines,
Brunei, Singapore, Indonesia and Malaysia.
1.24 "Licensed Dendreon Product" shall have the meaning set forth in
Section 2.3(b).
1.25 "Licensed Kirin Product" shall have the meaning set forth in Section
2.4(b).
1.26 "Net Revenue" means the total revenue received by a Party for sale
or other disposition of a Product by such Party or an Affiliate or Sublicensee
of such Party to a Third Party less the following to the extent actually
incurred or allowed with respect to such sale or disposition: (i) reasonable
costs paid, if any, by the Party to a Third Party on account of apheresis
performed as part of or in association with the Product; (ii) discounts,
including cash discounts, or rebates, retroactive price reductions or allowances
actually allowed or granted from the billed amount; (iii) credits or allowances
actually granted upon claims, rejections or returns of Products, including
recalls, regardless of the Party requesting such; (iv) freight, postage,
shipping and insurance charges paid for delivery of Product, to the extent
billed; and (v) taxes, duties or other governmental charges levied on or
measured by the billing amount when included in billing, as adjusted for rebates
and refunds; provided, however, that with respect to sales of a particular Kirin
Product or Licensed Dendreon Product by Kirin or its Affiliate or Sublicensee in
Japan, the "total revenue received", as set forth above in the first line of
this definition, shall not in any event be less than the XXX Xxxxx established
for insurance reimbursement of Single Treatment, less the average amount charged
by the particular hospital purchaser of such Product for the same number of
apheresis services and infusion services needed for and performed for Single
Treatment where such averages are calculated including all apheresis services or
infusion services, as applicable, that were performed for any purpose during the
applicable period.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
6
1.27 "XXX Xxxxx" means the maximum sale price for a particular
pharmaceutical or medical price as established by the Japanese National Ministry
of Health and Welfare.
1.28 "North America" means the United States and all possessions and
territories thereof, Canada, Greenland, Mexico, Guatemala, Costa Rica, Belize,
Nicaragua, Honduras, El Salvador, Panama, Haiti, the Dominican Republic, the
Bahamas, Cuba and the British Virgin Islands.
1.29 "Patent" means (i) a valid and enforceable patent, including any
extension, registration, confirmation, reissue, re-examination or renewal
thereof; and (ii) to the extent valid and enforceable rights are granted by a
governmental authority thereunder, a patent application.
1.30 "Patent Costs" means the fees and expenses paid to outside legal
counsel and other Third Parties, and filing and maintenance expenses, incurred
in connection with the establishment, maintenance of rights under Patents
applicable to Products including the costs of patent interference proceedings.
1.31 "Phase II" means that portion of a clinical development program that
provides for additional assessment of safety and preliminary assessment of
efficacy of a product in human volunteers or patients, which is intended to
gather information to support the pivotal human clinical trials using such
product in a particular country. Any such clinical development program shall be
performed in accordance with the U.S.A. Federal Food, Drug and Cosmetic Act and
applicable regulations promulgated thereunder (including without limitation 21
CFR Part 312), as amended from time to time, or the comparable foreign laws and
regulations in the applicable country.
1.32 "Product" means a Kirin Product or a Dendreon Product.
1.33 "Reagent" means, with respect to a particular Licensed Dendreon
Product, any proprietary reagent of Dendreon (excluding any reagents contained
in a Separation Device) that is required for commercial manufacture and/or use
of such Licensed Dendreon Product.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
7
1.34 "Reasonable Efforts" shall mean efforts and resources commonly used
in the research-based pharmaceutical industry for the research, development and
commercialization of a product at a similar stage in its product life taking
into account the establishment of the product in the marketplace, the
competitiveness of the marketplace, the proprietary position of the product, the
regulatory structure involved, the profitability of the product and other
relevant factors.
1.35 "Regulatory Approval" means any approvals, licenses, registrations
or authorizations of any federal, state or local regulatory agency, department,
bureau or other government entity, necessary for the manufacture, use, storage,
import, transport or sale of Products in a regulatory jurisdiction.
1.36 "Separation Devices" means any Dendreon device, including all
containers and proprietary reagents comprising such device, that is intended for
use by Dendreon and its licensees for the isolation and purification of
Dendritic Cells for use in human therapy by activation or loading with specific
antigen, engineered antigen or antigen gene, and infusion into a patient.
1.37 "Single Treatment" means a single course of treatment of a patient
involving isolation of such patient's Dendritic Cells, or other preparation of
appropriate Dendritic Cells, activation or loading with specific antigen,
engineered antigen or antigen gene, and infusion of such Dendritic Cells into a
patient (which may involve multiple infusions over several months), as
determined by the Steering Committee.
1.38 "Sublicensee" shall mean any Third Party expressly licensed by a
Party to make and sell one or more Products. A Sublicensee shall not include
distributors or sales agents that do no more than purchase and resell finished
Products on behalf of a Party.
1.39 "Steering Committee" shall have the meaning set forth in Section
3.1.
1.40 "Third Party Royalties" means royalties payable to a Third Party in
respect of the sale of Kirin Products or Dendreon Products other than royalties
payable with respect to licenses entered into prior to the Effective Date.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
8
1.41 "Third Party" means any entity other than Dendreon or Kirin or an
Affiliate of Dendreon or Kirin.
ARTICLE 2
LICENSES AND RELATED RIGHTS
2.1 Licenses Granted to Kirin.
(a) Subject to the terms of this Agreement, Dendreon hereby
grants to Kirin an exclusive license to use the Dendreon Technology to develop,
use, make, have made, sell and offer for sale Kirin Products in the Kirin
Territory. Kirin may grant sublicenses to its Affiliates under the license
rights granted by Dendreon in the foregoing license for any permitted purpose
without Dendreon's prior written approval and may grant sublicenses under such
rights to Third Parties solely for sale (but not therapeutic development) of
Kirin Products in the Kirin Territory without Dendreon's prior written approval.
Additionally, Kirin and its Affiliates may conduct clinical development of
particular Kirin Products in the Dendreon Territory and Joint Territory so long
as Kirin obtains Dendreon's prior written approval of the location and clinical
study protocol of any such clinical work or study of each such Kirin Product,
such approval not to be unreasonably withheld, and such work is intended to
generate data to be used in obtaining Regulatory Approval of such Kirin Product
for manufacturing, marketing and sale in the Kirin Territory.
(b) Subject to the terms of this Agreement (including without
limitation Section 2.4 and Article 5), Dendreon hereby grants to Kirin an
exclusive (except in the Joint Territory) license under the Dendreon Technology,
with the right to sublicense, to make, have made, use, sell and offer for sale
any Kirin Product created that contains a Kirin Antigen. The foregoing license
grant shall apply in countries where there is a patent or other intellectual
property right Controlled by Kirin covering such Kirin Antigen. Specifically
excluded from the license rights granted under this subsection (b) are any
rights to make, have made, use, import, sell and offer for sale in North America
any Kirin Product for which Dendreon has exercised the Dendreon Option pursuant
to Section 2.4.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
9
(c) Subject to the terms of this Agreement, Dendreon hereby
grants to Kirin an exclusive license to use the Dendreon Technology to use,
make, have made, import, sell and offer for sale Licensed Dendreon Products
solely in the Kirin Territory. Kirin may grant sublicenses under the license
rights granted by Dendreon in the foregoing to its Affiliates and to Third
Parties solely for sale of Licensed Dendreon Products in the Kirin Territory
without Dendreon's prior written approval. Additionally, Kirin and its
Affiliates may conduct clinical development of specific Licensed Dendreon
Products in the Dendreon Territory and Joint Territory so long as Kirin obtains
Dendreon's prior written approval of the location and clinical study protocol of
any such clinical work or study of a Licensed Dendreon Product, such approval
not to be unreasonably withheld, and such work is intended to generate data to
be used in obtaining Regulatory Approval of such Licensed Dendreon Product for
marketing and sale in the Kirin Territory.
(d) Subject to the terms of this Agreement, Dendreon grants to
Kirin a non-exclusive license to use the Dendreon Technology to make, have made,
use, sell and offer for sale Kirin Products in the countries in the world
outside of the Kirin Territory, North America and the Joint Territory; provided,
however, that Kirin and Dendreon shall mutually agree in writing upon any
Sublicensees of Kirin under the foregoing rights to sell the Kirin Products in
any such countries or territories, such agreement not to be unreasonably
withheld.
(e) Subject to the terms of Section 5.8, and except as
otherwise provided in the Manufacturing and Supply Agreement, the license rights
granted in the subsections (a) through (d) above are subject to the following
express limitation (and to all other obligations and limitations in the
Agreement): Kirin obtains no license or rights to make or to practice any of the
Dendreon Technology to make Separation Devices, Reagents or any other devices or
products for use in the isolation or purification of Dendritic Cells or any
other cells. Kirin may purchase Separation Devices and Reagents only under the
terms of the Manufacturing and Supply Agreement. Kirin may use Separation
Devices to isolate Dendritic Cells only as part of preparing a Kirin Product or
Licensed Dendreon Product or performing a service comprising a Kirin Product or
Licensed Dendreon Product.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
10
2.2 Licenses Granted to Dendreon.
(a) Subject to the terms of this Agreement, Kirin hereby grants to
Dendreon an exclusive license in the Dendreon Territory, with the right to
sublicense, under the Kirin Improvements and the Kirin Patents that claim such
Kirin Improvements to develop, make, have made, use, import and sell Dendreon
Products.
(b) Subject to the terms of this Agreement, Kirin hereby grants to
Dendreon an exclusive license under the Kirin Technology to use, make, have
made, import, sell and offer for sale Licensed Kirin Products in North America.
Dendreon may grant sublicenses under the license rights granted by Kirin in the
foregoing to its Affiliates and to Third Parties solely for the sale of Licensed
Kirin Products in North America.
2.3 Kirin Option to License Dendreon Products.
(a) Subject to the terms of this Section 2.3 and Article 5, Dendreon
hereby grants to Kirin an exclusive option (the "Kirin Option") to obtain an
exclusive license, with the right to sublicense, to conduct clinical development
on and to commercialize specific Dendreon Products in the Kirin Territory. The
Kirin Option is exercisable by Kirin, with respect to any particular Dendreon
Product in clinical development by Dendreon or its Afiliate, at any time
following the commencement of such clinical development, but no later than one
hundred ten (110) days after Dendreon delivers to Kirin a report on early Phase
II clinical trial data for such Dendreon Product (the "Kirin Option Period").
The report shall be available within thirty (30) days after completion of early
Phase II clinical trials for such Dendreon Product. To exercise the Kirin Option
for a particular Dendreon Product in development, Kirin shall provide Dendreon
written notice of Kirin's election prior to the expiration of the applicable
Kirin Option Period. Notwithstanding the above, Kirin shall have the right to
negotiate for an extension of the Kirin Option Period applicable to a particular
Dendreon Product. In consideration of any such extension, if any, the Parties
will negotiate in good faith compensation to be paid to Dendreon.
(b) If Kirin properly exercises the Kirin Option for a particular
Dendreon Product, then such Dendreon Product shall thereafter be deemed a
"Licensed Dendreon Product" for
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purposes of this Agreement. Kirin shall be entitled, subject to compliance with
the other terms of the Agreement, to exercise the license rights granted under
Section 2.1(c) with respect to such Licensed Dendreon Product. Kirin shall use
Reasonable Efforts to develop and obtain Regulatory Approval in the Kirin
Territory for each Licensed Dendreon Product. Kirin shall pay all the
development and registration costs for all such Licensed Dendreon Products in
the Kirin Territory. Kirin shall use Reasonable Efforts to market and sell in
the Kirin Territory all Licensed Dendreon Products for which Regulatory Approval
in the Kirin Territory has been obtained.
(c) For each Dendreon Product in development during the term of the
Agreement, Dendreon agrees that it shall not grant any rights, interests, or
options to any Third Parties for the commercialization of such Dendreon Product
in the Kirin Territory until the earlier of: (i) the expiration of the Kirin
Option Period applicable to such Dendreon Product without Kirin having exercised
such Kirin Option; or (ii) Kirin's failure to use Reasonable Efforts to develop
and market such Dendreon Product in the Kirin Territory at any time commencing
one hundred eighty (180) days after Kirin's exercise of the Kirin Option; or
(iii) termination of the Agreement. If Kirin fails to exercise the Kirin Option
as to a particular Dendreon Product, Dendreon shall have the right to develop
and commercialize such Dendreon Product in the Kirin Territory. Further, if
Kirin fails to use Reasonable Efforts to develop and market a Licensed Dendreon
Product in the Kirin Territory at any time commencing one hundred eighty (180)
days after Kirin's exercise of the Kirin Option, Dendreon shall have the right
to develop and commercialize such Licensed Dendreon Product in the Kirin
Territory upon ninety (90) days notice from Dendreon; provided, however, that if
Kirin initiates Reasonable Efforts to develop and market such Licensed Dendreon
Product in the Kirin Territory within the ninety (90) day notice period and
continues thereafter to use Reasonable Efforts to develop and market such
Licensed Dendreon Product in the Kirin Territory, then Dendreon shall not obtain
such rights unless and until Kirin does not continue using such Reasonable
Efforts. Dendreon's right to commercialize Dendreon Products for which the Kirin
Option has expired shall be subject to the following: If Kirin has any ongoing
or current research, development or commercial project involving Dendritic Cell-
based therapy for the same tumor type as is the subject of treatment by such
Dendreon Product, and the goal of such project is the creation of a Kirin
Product, and Kirin has
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previously identified such project to Dendreon prior to Dendreon's disclosure of
such Dendreon Product to Kirin, or has demonstrated the existence of such
project to Dendreon's reasonable satisfaction based on official notebook data
entries created prior to such disclosure, then Dendreon agrees not to develop
and market such Dendreon Product in the Kirin Territory, nor to grant to a Third
Party a license to develop and market such Dendreon Product in the Kirin
Territory, without obtaining Kirin's prior written consent. For clarity, the
requirement that Kirin use Reasonable Efforts in developing and commercializing
Licensed Dendreon Products does not necessarily require that Kirin expend such
efforts in every country in the Kirin Territory, so long as such efforts are
expended in each country where it is economically reasonable to do so.
2.4 Dendreon Option to License Kirin Products.
(a) Subject to the terms of this Section 2.4 and Article 5, Kirin
hereby grants to Dendreon an exclusive option (the "Dendreon Option") to obtain
an exclusive license, with the right to sublicense, to commercialize specific
Kirin Products in North America. The Dendreon Option is exercisable by Dendreon,
with respect to any particular Kirin Product in clinical development, at any
time following the commencement of such clinical development, but no later than
one hundred ten (110) days after Kirin delivers to Dendreon a report on early
Phase II clinical trial data for such Kirin Product (the "Dendreon Option
Period"). The report shall be available thirty (30) days after completion of
early Phase II clinical trials for such Kirin Product. To exercise the Dendreon
Option for a particular Kirin Product in development, Dendreon shall provide
Kirin written notice of Dendreon's election prior to the expiration of the
applicable Dendreon Option Period. Notwithstanding the above, Dendreon shall
have the right to negotiate for an extension of the Dendreon Option Period
applicable to a particular Kirin Product. In consideration of any such
extension, if any, the Parties will negotiate in good faith compensation to be
paid to Kirin.
(b) If Dendreon properly exercises the Dendreon Option for a
particular Kirin Product, then such Kirin Product shall thereafter be deemed a
"Licensed Kirin Product" for purposes of this Agreement. Dendreon shall be
entitled, subject to compliance with the other terms of the Agreement, to
exercise the license rights granted under Section 2.2(b) with respect
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to such Licensed Kirin Product. Dendreon shall pay all the development and
registration costs for all such Licensed Kirin Products in North America.
(c) For each Kirin Product in development during the term of the
Agreement, Kirin agrees that it shall not grant any rights, interests, or
options to any Third Parties for the commercialization of such Kirin Product in
North America until the earlier of: (i) the expiration of the Dendreon Option
Period applicable to such Kirin Product without Dendreon having exercised such
option; (ii) Dendreon's failure to use Reasonable Efforts to develop and market
such Kirin Product in North America at any time commencing one hundred eighty
(180) days after Dendreon's exercise of the Dendreon Option; or (iii)
termination of the Agreement. If Dendreon fails to exercise the Dendreon Option
as to a particular Kirin Product, Kirin shall have the right to develop and
commercialize such Kirin Product in North America. Further, if Dendreon fails to
use Reasonable Efforts to develop and market the respective Licensed Kirin
Product in North America at any time commencing one hundred eighty (180) days
after Dendreon's exercise of the Dendreon Option, Kirin shall thereafter have
the right to develop and commercialize such Kirin Product in North America, upon
ninety (90) days notice from Kirin; provided, however, that if Dendreon
initiates Reasonable Efforts to develop and market such Licensed Kirin Product
in North America within the ninety (90) day notice period and continues
thereafter to use Reasonable Efforts to develop and market such Licensed Kirin
Product in the North America, then Kirin shall not obtain such rights unless and
until Dendreon does not continue using Reasonable Efforts. Kirin's right to
commercialize Kirin Products for which the Dendreon Option has expired shall be
subject to the following: If Dendreon has any ongoing or current research,
development or commercial project involving Dendritic Cell-based therapy for the
same tumor type as is the subject of treatment by such Kirin Product, and the
goal of such project is the creation of a Dendreon Product, and Dendreon has
previously identified such project to Kirin prior to Kirin's disclosure of such
Kirin Product to Dendreon, or has demonstrated the existence of such project to
Dendreon's reasonable satisfaction based on official laboratory notebook data
entries created prior to such disclosure, then Kirin agrees not to develop and
market such Kirin Product in North America, nor to grant to a Third Party a
license to develop and market such Kirin Product in North America, without
obtaining Dendreon's prior written consent. For clarity, the requirement that
Dendreon use Reasonable Efforts in developing
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and commercializing Licensed Kirin Products does not necessarily require that
Dendreon expend such efforts in every country in North America, so long as such
efforts are expended in each country where it is economically reasonable to do
so.
2.5 Notice of Development. Upon reasonable request by Dendreon, Kirin
will provide Dendreon with Information regarding the Kirin Products that are in
clinical trials prior to Phase II. Upon reasonable request by Kirin, Dendreon
will provide Kirin with Information regarding the Dendreon Products that are in
clinical trials prior to Phase II.
2.6 Trademark Rights.
(a) License Grants.
(i) License to Dendreon. Subject to the limitations set forth
below, Kirin grants to Dendreon a non-exclusive, royalty-free license, with the
right to sublicense, to use any and all marks Kirin has adopted for use with
Kirin Products (the "Kirin Licensed Marks"), solely in connection with the
promotion and sale of Licensed Kirin Products in North America. Dendreon shall
not use Kirin Licensed Marks in connection with any other products or in any
other activities without prior written approval of Kirin.
(ii) License to Kirin. Subject to the limitations set forth
below, Dendreon grants to Kirin a non-exclusive, royalty-free license, with the
right to sublicense, to use any and all marks Dendreon has adopted for use with
the Dendreon Products (the "Dendreon Licensed Marks"), solely in connection with
the promotion and sale of Licensed Dendreon Products and Kirin Products in the
Kirin Territory. Kirin shall not use Dendreon Licensed Marks in connection with
any other products or activities without prior written approval of Dendreon.
(b) Additional Marks. The Parties may wish to extend this Agreement
to cover additional marks, including without limitation any marks for products
resulting from the Collaboration Program, which either Party may acquire and
desire to license to the other Party. The Parties agree that in such event, a
letter from either Party to the other Party specifying such additional marks
shall be sufficient to extend the applicable license granted herein, and all the
terms and conditions thereof, to such additional marks for the permitted
purposes.
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(c) Form of Use. Dendreon, its Affiliates and Sublicensees shall
use Kirin Licensed Marks only in the form(s) approved in writing by Kirin and
shall include where appropriate the designations (R) and (TM) and a statement
that Kirin Licensed Marks are the trademarks of Kirin Brewery Co., and other
proprietary notices as reasonably required by Kirin from time-to-time.
Similarly, Kirin, its Affiliates and Sublicensees shall use Dendreon Licensed
Marks only in the form(s) set forth on Exhibit D hereto or otherwise approved in
writing by Dendreon and shall include where appropriate the designations (R) and
(TM) and a statement that Dendreon Licensed Marks are the trademarks of Dendreon
Corporation, and other proprietary notices as reasonably required by Dendreon
from time-to-time. The Parties agree to comply with all applicable laws and
regulations pertaining to the proper use and designation of trademarks.
(d) Ownership of Licensed Marks.
(i) Ownership. Each Party acknowledges that it has no interest
in the other Party's Licensed Marks other than the license granted under this
Agreement and that each Party is, and will continue to be, the sole and
exclusive owner of all right, title and interest in its respective Licensed
Marks.
(ii) No Contest. Each Party agrees that it will not contest,
oppose or challenge the other Party's ownership of its Licensed Marks. Each
Party agrees that it will do nothing to impair the other Party's ownership or
rights in its Licensed Marks. In particular, neither Party will register or
attempt to register the other Party's Licensed Marks in any jurisdiction nor
oppose the other's registration of its Licensed Marks, alone or with other words
or designs, in any jurisdiction. If either Party uses, registers or applies to
register a licensed xxxx that violates its obligations under this section, such
Party agrees, at the other's request, to abandon the use of such xxxx and any
application or registration for such xxxx.
(iii) Adverse Use. Each Party shall notify the other Party of
any adverse use by a Third Party of the other Party's Licensed Marks or of a
xxxx or name confusingly similar to the other's Licensed Marks and agrees to
take no action with respect thereto except with the other's prior written
authorization. The Party that owns any infringed Licensed Marks may thereupon
take such action as it in its sole discretion deems advisable for
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the protection of its rights in and to its Licensed Marks, including allowing
the licensed Party to bring and prosecute a claim against such Third Party at
the licensed Party's expense. Each Party further agrees to provide full
cooperation with any legal or equitable action by the other Party to protect the
other's rights, title and interest in its Licensed Marks.
(e) Quality Control.
(i) Kirin's Obligations. The nature and quality of all goods
sold by Kirin, its Affiliates and Sublicensees in connection with Dendreon
Licensed Marks and all advertising and promotional uses and all other related
uses of Dendreon Licensed Marks by Kirin, its Affiliates and Sublicensees shall
conform to Dendreon's standards. Kirin further agrees to provide samples of
advertising and other promotional material bearing Dendreon Licensed Marks to
Dendreon for approval at least thirty (30) days before such materials are to be
distributed, displayed or otherwise used. Kirin, its Affiliates and Sublicensees
will not distribute, display or otherwise use such materials without Dendreon's
prior written approval, which approval shall not be unreasonably withheld.
(ii) Dendreon's Obligations. The nature and quality of all goods
sold by Dendreon, its Affiliates and Sublicensees in connection with Dendreon's
use of Kirin Licensed Marks and all advertising and promotional uses and all
other related uses of Kirin Licensed Marks by Dendreon, its Affiliates and
Sublicensees shall conform to Kirin's standards. Dendreon further agrees to
provide samples of advertising and other promotional material bearing Kirin
Licensed Marks to Kirin for approval at least thirty (30) days before such
materials are to be distributed, displayed or otherwise used. Dendreon, its
Affiliates and Sublicensees will not distribute, display or otherwise use such
materials without Kirin's prior written approval, which approval shall not be
unreasonably withheld.
(f) Confusingly Similar and/or Combination Marks.
(i) Kirin's Obligations. Kirin agrees that Kirin, its
Affiliates and Sublicensees will not adopt or use any other trademarks, words,
symbols, letters, designs or marks (i) in combination with Dendreon Licensed
Marks in a manner that would create
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combination marks or (ii) that would be confusingly similar to Dendreon Licensed
Marks, provided, however, that Kirin, its Affiliates and Sublicensees may use
Dendreon Licensed Marks with other marks or names if such other marks or names
are sufficiently separated from Dendreon Licensed Marks and sufficiently
distinctive to avoid the consumer impression that such other marks or their
owners are associated with Dendreon.
(ii) Dendreon's Obligations. Dendreon agrees that Dendreon, its
Affiliates and Sublicensees will not adopt or use any other trademarks, words,
symbols, letters, designs or marks (i) in combination with Kirin Licensed Marks
in a manner that would create combination marks or (ii) that would be
confusingly similar to Kirin Licensed Marks, provided, however, that Dendreon,
its Affiliates and Sublicensees may use Kirin Licensed Marks with other marks or
names if such other marks or names are sufficiently separated from Kirin
Licensed Marks and sufficiently distinctive to avoid the consumer impression
that such other marks or their owners are associated with Kirin.
ARTICLE 3
MANAGEMENT
3.1 The Steering Committee. Dendreon and Kirin agree to form, as of the
Effective Date, a committee to facilitate the research and development of Kirin
Products and Dendreon Products ("the Steering Committee"). The Steering
Committee shall be comprised of four (4) individuals, two (2) being Dendreon
employees appointed and replaced by Dendreon at its discretion and two (2) being
Kirin employees appointed and replaced by Kirin at its discretion. The size and
composition of the Steering Committee may be by mutual agreement of the Parties.
The Parties shall form the Steering Committee within twenty (20) days after the
Effective Date. The Steering Committee shall have the following authority and
obligations:
(a) To encourage and facilitate the ongoing cooperation of the
Parties in conducting the research and development of Kirin Products and
Dendreon Products;
(b) To establish and implement specific plans for accomplishing the
tasks and goals of the Parties as set forth in the Agreement;
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(c) To coordinate the communication, information exchange and
efforts of the Parties with respect to all matters under this Agreement; and
(d) To discuss and resolve, if possible, any issues or disputes that
arise under the Agrement.
3.2 Steering Committee Meetings. The Steering Committee shall act at
meetings held regularly with all members present, according to the following:
(a) The Steering Committee meetings shall take place at such times
and places as shall be determined by the Steering Committee but no less
frequently than once per six (6) months; it is expected that the meetings will
alternate between appropriate offices of each Party, or at such other convenient
locations as agreed;
(b) If requested by a Party, the Steering Committee may conduct a
particular meeting by telephone or video conference or other acceptable
electronic means, provided that all Steering Committee members attend such
meeting and can hear and communicate with all other members, and any decisions
made during such meeting are recorded in writing and confirmed by signature of
at least one of the Steering Committee members from each of the Parties;
(c) A Party may bring a reasonable number of additional
representatives, in a non-voting capacity, to attend appropriate Steering
Committee meetings, provided that such attendance is helpful to the Steering
Committee carrying out its tasks and obligations;
(d) Prior to each meeting, the designated chair of the Steering
Committee (which may vary during the term) shall circulate an agenda for the
meeting, and the Steering Committee shall keep minutes reflecting matters
discussed and the actions taken at the meeting, a copy of which shall be
provided to each Party; and
(e) The Steering Committee may act on a specific issue or matter
without a meeting if the Steering Committee members all agree as to such action
and such agreement is set forth in a written consent signed by all the members
of the Steering Committee.
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3.3 Decision-Making and Issue Resolution. All decisions of or actions
taken by the Steering Committee shall be by unanimous approval of all the
members of the Steering Committee or such subcommittee, and voting on any
matters shall be reflected in the minutes of the meeting at which the vote was
taken. If the Steering Committee fails to reach unanimous agreement on an issue
or matter needing resolution, the matter shall be referred for good faith
discussion and resolution by the appropriate senior executive officer of each
Party.
3.4 Research Efforts and Expenses. Each of the Parties will maintain
scientific staff, laboratories, offices and other facilities necessary to carry
out the tasks and obligations assigned to it pursuant to this Agreement. Each
party shall use Reasonable Efforts to conduct and complete such tasks and
obligations. Kirin will bear all of its own expenses incurred in connection
with research and development of Kirin Products and Licensed Dendreon Products
by Kirin in the Kirin Territory or in North America pursuant to Section 2.4(c).
Dendreon shall bear all of its own expenses incurred in connection with research
and development of Dendreon Products and Licensed Kirin Products by Dendreon in
the Dendreon Territory or in the Kirin Territory, pursuant to Section 2.3(c).
3.5 Other Research. Kirin acknowledges and agrees that nothing in this
Agreement shall prevent or otherwise hinder Dendreon from conducting, and
Dendreon shall retain full rights to conduct, its own independent research and
development work with respect to Dendreon Technology or any aspect thereof for
any use or purpose outside the Kirin Territory or any use or purpose outside the
Field in the Kirin Territory, and including conducting such research and
development work with or on behalf of Third Party partners.
ARTICLE 4
DEVELOPMENT AND MARKETING IN THE JOINT TERRITORY
4.1 Collaborative Development and Marketing. The Parties agree jointly to
conduct clinical development of, and to commercialize in the Joint Territory,
all Kirin Products and any Collaboration Products (as such term is defined in
the Research and License Agreement) that result from the Research Program. Such
collaborative clinical development and marketing shall be conducted pursuant to
a Commercialization Agreement to be negotiated and agreed to and
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signed by the Parties, which agreement shall be consistent with the applicable
provisions of the Kirin/Dendreon Term Sheet and with the summary terms set forth
below, and will contain, in addition, such other reasonable and typical terms as
are consistent with similar agreements in the industry and the following terms:
Under the terms of such agreement, Dendreon and Kirin shall share equally in all
the costs of conducting clinical development of such Kirin Products and
Collaboration Products in the Joint Territory and shall share equally the
marketing profits from sales of such Kirin Products and Collaboration Products
in the Joint Territory, with "marketing profit" understood to mean the total
revenue derived from such sales less the actual costs directly attributable to
the manufacture, marketing and sale of such products. The details of such joint
clinical development and marketing arrangement shall be set forth in a
Commercialization Agreement consistent with the foregoing.
ARTICLE 5
FEES AND ROYALTIES
5.1 Technology Transfer Fee. Kirin shall pay Dendreon a non-refundable
technology transfer fee in the amount of eight million U.S. dollars
($8,000,000), payable in accordance with the following schedule:
(a) Five million dollars ($5,000,000) in cash on the Effective
Date.
(b) Three million dollars ($3,000,000) in cash within [ * ] of the
[ * ] of the [ * ] for the [ * ]. For purposes of this Section, [ * ] means
[ * ] on which [ * ] in [ * ] to [ * ] the [ * ].
The foregoing technology transfer fee payments are inclusive of such
withholding taxes as are finally ascertained to be due and payable by Kirin on
account of Dendreon and shall be made by wire transfer to an account designated
by Dendreon for such purpose.
5.2 Royalties on Sales of Kirin Products.
(a) Subject to subsection (b) below, Kirin shall pay Dendreon
royalties on sales of Kirin Products by or on behalf of Kirin or its Affiliates
or Sublicensees in any country excluding the Joint Territory, as follows:
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(i) Kirin shall pay royalties equal to [ * ] of the Net
Revenue based on sales of Kirin Products in such countries by Kirin and its
Affiliates and Sublicensees (except as otherwise provided in subclause (ii)
below);
(ii) for so long as China or another country in the Kirin
Territory imposes an upper limit on royalties transferable outside of China or
such other country, Kirin shall pay royalties on the Net Revenue based on sales
of the Kirin Products sold in such countries equal to the greater of: (A) [ * ]
of any such upper limit; or (B) [ * ] of such Net Revenue; provided that the
royalty payable under this Section 5.2(a)(ii) shall not exceed [ * ] of such Net
Revenue for any particular royalty accounting period.
(b) For each particular Kirin Product, Kirin shall pay the royalties
specified above, on a country by country basis, until the later of the
expiration of ten (10) years from the first commercial launch of such Kirin
Product in such country or the last to expire of the Patents with claims
covering such Kirin Product or its manufacture or use in such country. The
foregoing royalty payments are inclusive of such withholding taxes as are
finally ascertained to be due and payable by Kirin on account of Dendreon, and
shall be made by wire transfer to an account designated by Dendreon for such
purpose.
5.3 Royalties on Sales of Licensed Dendreon Products.
(a) Subject to subsection (b) below, Kirin shall pay Dendreon
royalties on sales of Licensed Dendreon Products in the Kirin Territory as
follows:
(i) Kirin shall pay a royalty equal to [ * ] of the Net
Revenue based on sales of Licensed Dendreon Products sold in the Kirin Territory
by Kirin or its Affiliates or Sublicensees (except as otherwise provided in
subclause (ii) below);
(ii) for so long as China or any other country in the Kirin
Territory imposes an upper limit on royalties transferable outside of China or
such other country, Kirin shall pay Dendreon a royalty based on the Net Revenue
for Licensed Dendreon Products sold in such countries equal to the greater of:
(A) [ * ] of any such upper limit; or (B) [ * ] of such Net
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Revenue; provided that the royalty payable under this Section 5.3(a)(ii) shall
not exceed [ * ] of such Net Revenue for any particular royalty accounting
period.
(b) Kirin shall pay the royalties specified above, on a country by
country basis until the later of the expiration of ten (10) years from the first
commercial launch of the first Dendreon Product in such country or the last to
expire of the Patents with claims covering any Dendreon Product in such country.
The foregoing royalty payments are inclusive of such withholding taxes as are
finally ascertained to be due and payable by Kirin on account of Dendreon, and
shall be made by wire transfer to an account designated by Dendreon for such
purpose.
5.4 Royalties on Dendreon Sales of Licensed Kirin Products . Dendreon shall
pay Kirin a royalty equal to [ * ] of the Net Revenue based on sales of Licensed
Kirin Products sold by Dendreon, its Affiliates or any of its Sublicensees in
North America. With respect to each such Licensed Kirin Product, Dendreon shall
pay the royalties specified above on a country by country and product by product
basis until the later of the expiration of ten (10) years from the first
commercial launch of such Licensed Kirin Product in such country or the last to
expire of the Patents with claims covering such Licensed Kirin Product in such
country. The foregoing royalty payments are inclusive of such withholding taxes
as are finally ascertained to be due and payable by Dendreon on account of
Kirin, and shall be made by wire transfer to an account designated by Kirin for
such purpose.
5.5 Kirin Milestone Payments. Kirin shall make to Dendreon the following
non-refundable milestone payments on a product by product basis for each
Licensed Dendreon Product for which Kirin has exercised the Kirin Option:
Within [ * ] of the [ * ] of the [ * ] $1,000,000
Within [ * ] of the [ * ] of [ * ] $2,000,000
Within [ * ] of [ * ] $2,000,000
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The foregoing milestone payments are inclusive of such withholding taxes as are
finally ascertained to be due and payable by Kirin on account of Dendreon and
shall be made by wire transfer to an account designated by Dendreon for such
purpose.
5.6 Dendreon Milestone Payments. Dendreon shall make to Kirin the
following non-refundable milestone payments on a product by product basis for
each Licensed Kirin Product for which Dendreon has exercised the Dendreon
Option:
Within [ * ] of the [ * ] of the [ * ] $1,000,000
Within [ * ] of the [ * ] of [ * ] the [ * ] $2,000,000
Within [ * ] of [ * ] the [ * ] $2,000,000
The foregoing payments are inclusive of such withholding taxes as are finally
ascertained to be due and payable by Dendreon on account of Kirin and shall be
made by wire transfer to an account designated by Kirin for such purpose.
5.7 Payment of Royalties. Royalty obligations hereunder shall accrue at
the time of sale of the applicable Product, and all such royalties that have
accrued during a particular calendar quarter shall be paid quarterly within
sixty (60) days after the end of such calendar quarter. Such royalties shall be
calculated on the basis of Net Revenue in the local currency of each country,
and converted into U.S. Dollars and paid in U.S. Dollars on the basis of the
average currency exchange rate for the applicable calendar quarter quoted by the
Tokyo Mitsubishi Bank (or its successor) for currency exchanges in excess of one
million U.S. dollars ($1,000,000). Each royalty payment shall be accompanied by
a statement of such royalties showing the Net Revenue for the applicable
royalty-bearing Products, on a country by country and product by product basis.
If a Party receives a refund or rebate for taxes it paid on behalf of the other
Party, the Party receiving such refund or rebate shall promptly remit it to the
other Party.
5.8 Royalty Structure and Marketing Strategy. The terms of this Agreement
permit Kirin to market and sell Kirin Products and Licensed Dendreon Products to
hospitals and other similar health-care provider organizations as services or as
products comprising Dendritic
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Cells activated or loaded with specific antigen, engineered antigen or antigen
gene, including without limitation a Kirin Antigen. Kirin shall not, and
covenants not to, sell Separation Devices, Reagents or Dendreon Antigens to
Third Parties except as permitted in this Agreement. The Parties agree to
discuss alternative marketing strategies for Kirin Products and Licensed
Dendreon Products when commercially reasonable to do so. At such time, the
Parties also shall agree on any needed adjustment to the royalty calculation
mechanism established for sales of such Kirin Products and Dendreon Products,
including appropriate amendments to the definitions of such terms under Article
1. For example, if the Parties agree that Kirin may sell devices and reagents
(including specific antigens) for use by a Third Party in isolating and
activating Dendritic Cells, then such definitions may be amended to include the
concept that a Dendreon Product or Kirin Product includes any set of products
that are developed by the applicable Party and are intended for use in preparing
a product meeting the criteria in subsection 1.7(a) or 1.22(a), as applicable,
or in performing a service as set forth in subsection 1.7(b) or 1.22(b), as
applicable. Any change to the current marketing strategy, and any adjustment to
the royalty calculation mechanism related thereto, must be set forth in writing
and signed by an authorized representative of each Party. Neither Party shall
have any obligation to make changes to the marketing strategy already
established in this Agreement.
ARTICLE 6
EQUITY INVESTMENT BY KIRIN
6.1 Stock Purchase at IPO. In further consideration for the license
granted by Dendreon to Kirin under the Agreement, in addition to Kirin's
purchase of two million dollars ($2,000,000) worth of Series D preferred shares
of Dendreon on July 31, 1998, Kirin agrees to purchase from Dendreon, in a
private placement, five million dollars ($5,000,000) worth of unregistered
Dendreon common stock at the time of Dendreon's initial public offering (IPO),
with the price per share for such purchase equal to the price of the sale of
Dendreon's stock to the public in such IPO, provided that an initial public
offering of Dendreon shares of common stock is completed by January 1, 2000.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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6.2 Put Right. In the event that Dendreon has not completed an IPO by
January 1, 2000, then Dendreon will thereafter have the right, at its sole
option but only until January 1, 2001, to require Kirin to purchase up to one
million (1,000,000) shares of Dendreon preferred stock at a per share purchase
price to be negotiated by the Parties in good faith reflecting the fair value of
such stock, but in any event not less than the per share purchase price of the
most recent private sale of Dendreon preferred stock in excess of an aggregate
of one million dollars ($1,000,000) of preferred stock, and provided that the
total amount of the purchase price for such stock shall not exceed five million
dollars ($5,000,000). Dendreon shall exercise such right in writing to Kirin
prior to January 1, 2001, and upon such exercise the Parties shall negotiate the
purchase price in good faith and close the purchase of the capital stock as soon
as reasonably practicable, but in no event longer than sixty (60) days from the
date that Dendreon exercised such option. Dendreon may not exercise such right
after January 1, 2001, unless otherwise agreed to by the Parties in writing.
6.3 No Double Purchase. For clarity, it is agreed that, under the terms
of this Article 6, Kirin is required to purchase Dendreon stock only under
Section 6.1 in a private placement in conjunction with the IPO, or under Section
6.2 after exercise of the Dendreon's put right therein, but shall not be
required to purchase Dendreon stock under both such Sections.
ARTICLE 7
CONFIDENTIALITY
7.1 Confidentiality; Exceptions. Except to the extent expressly
authorized by this Agreement or otherwise agreed in writing, the Parties agree
that, for the term of this Agreement and for ten (10) years thereafter, the
receiving Party shall keep confidential and shall not publish or otherwise
disclose to a Third Party or use for any purpose other than as provided for in
this Agreement any Information and materials furnished to it by the other Party
pursuant to this Agreement (collectively, "Confidential Information"), except to
the extent that it can be established by the receiving Party by competent proof
that such Confidential Information:
(a) was already known to the receiving Party, other than under an
obligation of confidentiality, at the time of disclosure by the other Party;
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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(b) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the receiving Party;
(c) became generally available to the public or otherwise part of the
public domain after its disclosure and other than through any act or omission of
the receiving Party in breach of this Agreement; or
(d) was disclosed to the receiving Party, other than under an
obligation of confidentiality, by a Third Party who had no obligation to the
disclosing Party not to disclose such information to others.
7.2 Authorized Disclosure. Each Party may disclose the other's
Confidential Information to the extent such disclosure is reasonably necessary
in filing or prosecuting patent applications, prosecuting or defending
litigation, complying with applicable governmental regulations or conducting
preclinical or clinical trials, provided that if a Party is required by law or
regulation to make any such disclosure of the other Party's Confidential
Information it will except where impracticable for necessary disclosures, for
example in the event of medical emergency, give reasonable advance notice to the
other Party of such disclosure requirement and, except to the extent
inappropriate in the case of patent applications, will use its best efforts to
secure confidential treatment of such Confidential Information required to be
disclosed.
7.3 Survival. This Article 7 shall survive the termination or expiration
of this Agreement for a period of ten (10) years.
ARTICLE 8
INTELLECTUAL PROPERTY
8.1 Ownership. Each Party shall solely own Patents for any inventions
made solely by that Party's employees or consultants in the course of performing
any work under this Agreement. The law of inventorship of the United States
shall apply to any inventions whether made inside or outside the United States
by either of the Parties.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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8.2 Prosecution and Maintenance of Patents by Dendreon; Abandonment.
Dendreon shall have the responsibility to file, prosecute and maintain the
Dendreon Patents in the world and shall bear all expenses associated therewith.
All decisions regarding prosecution of the Dendreon Patents in the world will be
at Dendreon's sole discretion and responsibility. Dendreon agrees to keep Kirin
informed of the course of patent prosecution or other proceedings relating to
the Dendreon Patents in the Kirin Territory in the Field. In the event Dendreon
elects not to prosecute a Dendreon Patent application filed or to abandon an
issued Dendreon Patent in the Kirin Territory in the Field, Dendreon shall
notify Kirin not less than two (2) months before any relevant deadline, and
thereafter Kirin shall have the right to pursue, at its expense and sole
discretion, prosecution of such Dendreon Patent application or maintenance of
such issued Patent. In such event, Dendreon shall promptly assign its rights
therein to Kirin.
8.3 Prosecution and Maintenance of Patents by Kirin; Abandonment. Kirin
shall have the responsibility to file, prosecute and maintain the Kirin Patents
in the world and shall bear all expenses associated therewith. All decisions
regarding prosecution of the Kirin Patents in the world will be at Kirin's sole
discretion and responsibility. Kirin agrees to keep Dendreon informed of the
course of patent prosecution or other proceedings relating to the Kirin Patents
in North America in the Field. In the event Kirin elects not to prosecute a
Kirin Patent application filed, or to abandon an issued Kirin Patent in North
America in the Field, Kirin shall notify Dendreon not less than two (2) months
before any relevant deadline, and thereafter Dendreon shall have the right to
pursue, at its expense and in its sole discretion, prosecution of such Kirin
Patent application or maintenance of such issued Patent. In such event, Kirin
shall promptly assign its rights therein to Dendreon.
8.4 Defense and Settlement of Third Party Claims. If a Third Party files
a claim, suit or action against a Party claiming that a Patent or other
intellectual property right owned by such Third Party is infringed by the
development, use, marketing, distribution or sale of a Kirin Product or Dendreon
Product, and such claim, suit or action (a "Claim") arises out of such Party's
practice in the Field pursuant to this Agreement, the Party against whom the
Third Party has filed such Claim ("Defending Party") will have the right to
defend against any such Claim. The other Party will assist in the defense of any
such Claim as reasonably requested by the
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Defending Party and at the Defending Party's expense and may retain separate
counsel at its own expense. The Defending Party shall not settle any such Claim
without the prior express written consent of the other Party, which consent
shall not be unreasonably withheld or delayed, if such settlement would impose
on such other Party the obligation to pay any damages or would adversely affect
such Party's rights.
8.5 Third Party Royalties. In the event that a Party is required to
obtain a license under a Third Party patent that covers or claims the
manufacture, use or sale of a Kirin Product or Dendreon Product in order to
practice a Dendreon Patent or Kirin Patent to sell a Kirin Product or Dendreon
Product as permitted under the licenses in Article 2, provided, that such Party
shall disclose the relevant portions of such license under such Third Party
patent to the other Party in English and, if any, the extent of any alleged
infringement, such Party shall be entitled to deduct [ * ] of any royalties
owing to such Third Party based on the sale of such Kirin Products or Dendreon
Products under such license from amounts owing to the other Party, subject to a
maximum royalty reduction of [ * ] of the amounts that otherwise would be owed
by such Party under Article 5 hereof.
8.6 Enforcement of Patent Rights
(a) If any Dendreon Patent or Kirin Patent in the Field is infringed
by a Third Party, the Party to this Agreement first having knowledge of such
infringement shall promptly notify the other in writing. The notice shall set
forth the facts of such infringement in reasonable detail.
(b) Dendreon shall have the right, but not the obligation to
institute, prosecute and control any action or proceeding with respect to
infringement of Dendreon Patents in the Dendreon Territory, Kirin Patents in
North America and patents abandoned by Kirin pursuant to Section 8.3.
(c) Kirin shall have the right, but not the obligation, to institute,
prosecute and control any action or proceeding with respect to infringement of
Dendreon Patents in the Kirin
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COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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Territory, Kirin Patents in the Kirin Territory and the rest of the world except
North America and the Joint Territory, and patents abandoned by Dendreon
pursuant to Section 8.2.
(d) If a Party given the right to enforce a Kirin Patent or Dendreon
Patent pursuant to Section 8.6(b) or Section 8.6(c) fails to bring an action or
proceeding against a suspected infringer within a period of ninety (90) days
after having knowledge of such infringement in the Field, the other Party shall
have the right to bring and control an action against such infringer by counsel
of its own choice, and the non-enforcing Party shall have the right to be
represented in any such action by counsel of its own choice at its own expense.
(e) The Party controlling an action involving any infringement in the
Field shall consider in good faith the interests of the other Party in so doing,
and shall not settle or consent to an adverse judgment in any such action which
would have a material adverse effect on the rights or interests of the other
Party without the prior express written consent of such other Party. If one
Party brings any such action or proceeding, the other Party agrees to be joined
as a Party plaintiff if necessary to prosecute the action and to give the first
Party reasonable assistance and authority to file and prosecute the suit. In
each case relating to infringement within the Field, each Party shall bear the
costs of its enforcement of the Patent rights discussed in this section and
retain for its own account any amounts received from Third Parties; provided,
however, that any such recovery shall be deemed Net Revenue of the infringed
Product, subject to the royalty provisions of Article 5.
(f) The Parties shall consult regarding the institution, prosecution
and control of any action or proceeding with respect to infringement outside the
Field of any of the Dendreon Patents or Kirin Patents. In the absence of
Agreement with respect to infringement outside the Field, the Party owning the
infringed Kirin Patent or Dendreon Patent may proceed in such manner as the law
permits.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
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ARTICLE 9
REPRESENTATIONS AND WARRANTIES
9.1 Representations and Warranties. Each of the Parties hereby
represents and warrants as follows:
(a) This Agreement is a legal and valid obligation binding upon such
Party and enforceable in accordance with its terms. The execution, delivery and
performance of the Agreement by such Party does not conflict with any agreement,
instrument or understanding, oral or written, to which it is a Party or by which
it is bound, nor violate any law or regulation of any court, governmental body
or administrative or other agency having jurisdiction over it.
(b) Such Party has not, and during the term of the Agreement will
not, grant any right to any Third Party relating to its respective technology in
the Field licensed to the other Party hereunder which would conflict with such
rights granted to the other Party.
ARTICLE 10
REPORTS, RECORDS AND SAMPLES
10.1 Sharing of Information. Commencing on the Effective Date and
continuing during the term of this Agreement, each Party will make available and
disclose to the other Party the Information Controlled by such Party that
reasonably relates to such other Party's activities under this Agreement in the
Field. In particular, Dendreon will disclose to Kirin on a regular basis the
Dendreon Technology and provide reasonable assistance to Kirin (at Kirin's
request and expense) in transferring such Dendreon Technology for use in
developing Kirin Products and for use in commercializing the Licensed Dendreon
Products in the Kirin Territory. Similarly, Kirin will disclose to Dendreon on a
regular basis the Kirin Technology and provide reasonable assistance to Dendreon
(at Dendreon's request and expense) in transferring such Kirin Technology for
use in developing Dendreon Products and for use in commercializing the Licensed
Kirin Products in North America. In addition, both Parties will disclose to each
other any non-clinical and clinical regulatory information which relates to such
other Party's activities under this Agreement in the Field.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
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10.2 Records of Net Revenue. Each Party will maintain complete and
accurate records of Net Revenue which are relevant to payments to be made under
this Agreement. Such records shall be open during reasonable business hours, for
a period of three (3) years from creation of individual records, for examination
at the other Party's expense, and not more often than once each year and upon
not less than thirty (30) days advance notice, by a certified public accountant
selected by the other Party and acceptable to the Party keeping the records for
the sole purpose of verifying for the inspecting Party the correctness of
calculations or payments made under this Agreement.
10.3 Materials. The Parties intend to maintain an open and extensive
exchange of biological, chemical and other tangible materials during the course
of the Agreement. Information obtained by the other Party in the testing of
such materials will be promptly disclosed to the Party providing the sample, and
all such Information will be considered Information to be protected by both
Parties under the restrictions of Article 7.
10.4 Publicity Review. If either Party is required by law or regulation
to make a public disclosure or announcement concerning this Agreement or the
subject matter thereof, such Party shall give reasonable prior advance notice of
the proposed text of such disclosure or announcement to the other Party for its
review and comment. The terms of this Agreement may also be disclosed to Third
Parties with the consent of the other Party, which consent shall not be
unreasonably withheld so long as such disclosure is made under a binder of
confidentiality.
10.5 Publications. Each Party agrees that it shall not publish or
present the results of studies carried out pursuant to this Agreement without
the opportunity for prior review by the other Party. Each Party shall provide to
the other the opportunity to review any proposed abstracts, manuscripts or
presentations (including information to be presented verbally) which relate to
the Field at least thirty (30) days prior to their intended submission for
publication and such submitting Party agrees, upon written request from the
other Party, not to submit such abstract or manuscript for publication or to
make such presentation until the other Party is given a reasonable period of
time to secure patent protection for any material in such publication or
presentation which it believes is patentable.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
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10.6 Adverse Event Reporting. In the event that either Party, its
Affiliates or Sublicensees obtains, directly or indirectly, information and data
on the side effects or toxicity of a Product during the development, marketing
and distribution of any of the Products hereunder, such Party shall disclose, as
soon as reasonably practicable, such information and data to the other Party.
Either Party, its Affiliates and Sublicensees shall notify the other Party as
soon as reasonably practicable of any complaints or reports of adverse events
associated with the Products which are serious, new or unexpected events, or
events with increased frequency. All other adverse events associated with
Products shall be reported by either Party to the other Party in summary format
at least quarterly. At the request of either Party, the other Party shall
cooperate in the investigation and respond to any Product complaints which may
relate to the role of the informed Party in the development or manufacture of
the Products. Each Party shall be responsible for all reporting of adverse
events to regulatory authorities in its respective territory.
ARTICLE 11
TERM AND TERMINATION
11.1 Term. This Agreement shall commence on the Effective Date and,
unless sooner terminated as provided herein, shall continue in effect until the
expiration of all of the payment obligations of Kirin and Dendreon under the
Agreement.
11.2 Termination for Breach. If either Party materially breaches this
Agreement at any time, which breach is not cured within thirty (30) days of
written notice thereof if such breach is caused by the failure of a Party to
meet its financial obligations under this Agreement, or within ninety (90) days
of written notice thereof for any other material breach of this Agreement, from
the non-breaching Party specifying in detail the nature of the breach, the
breaching Party's licenses granted in this Agreement shall terminate and the
non-breaching Party shall have the exclusive, royalty-free right under the
breaching Party's Technology, Patents and Licensed Marks to make, have made, use
and sell Products it already had developed or sold, in those countries in which
it already had developed or sold such Products. The breaching Party will assist
the non-breaching Party in every proper way to effect the license granted above.
The breaching Party shall further deliver to the non-breaching Party such
relevant tangible materials
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
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embodying such Technology, Patents and Licensed Marks as may be necessary or
useful to the exercise of the non-breaching Party of the license hereunder.
11.3 Surviving Rights. The obligations and rights of the Parties under
Articles 7, 8 and 12, and Sections 2.6(c)-(f), 10.4, 10.5, 13.6 and 13.7 of this
Agreement will survive termination.
11.4 Non-exclusive Licenses after Expiration. Upon the expiration of the
Agreement under Section 11.1, Kirin shall retain a non-exclusive, royalty-free
license to use the Dendreon Technology and Dendreon Licensed Marks to make, have
made, use offer for sale and sell in the Kirin Territory the Kirin Products and
Licensed Dendreon Products that Kirin was selling as of the date of such
expiration, and Dendreon shall retain a non-exclusive, royalty-free license to
use the Kirin Technology and Kirin Licensed Marks to make, have made, use, offer
for sale and sell in North America the Dendreon Products and Licensed Kirin
Products that Dendreon was selling as of the date of such expiration.
11.5 Termination Without Cause. On or after January 1, 2002, Kirin may
terminate this Agreement without cause upon ninety (90) days prior written
notice to Dendreon. At such time, all licenses granted to Kirin under this
Agreement shall terminate, and Kirin shall covenant not to use any Information
or materials of any kind related to, made or derived from the Dendreon
Technology or Dendreon Licensed Marks after such termination. Kirin also shall
return to Dendreon all Information and materials of any kind related to, made or
derived from the Dendreon Technology or Dendreon Licensed Marks upon such
termination. Kirin's licenses to Dendreon under this Agreement shall survive
any such termination. Dendreon's royalty obligations to Kirin shall survive any
such termination and shall terminate as provided in Article 5.
ARTICLE 12
INDEMNIFICATION
12.1 Indemnification in Kirin Territory. Kirin shall indemnify, defend
and hold Dendreon harmless from and against any and all liability, damage, loss,
cost (including
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EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
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reasonable attorneys' fees) and expense resulting from any infringement, claim
of bodily injury or property damage (a) relating to the development,
manufacture, use, distribution or sale of any Product by Kirin, its Affiliates,
Sublicensees, employees or agents or (b) due to the negligence or willful
misconduct of Kirin or its Affiliates, Sublicensees, employees or agents.
12.2 Indemnification in the Dendreon Territory. Dendreon shall indemnify
and hold Kirin harmless from and against any and all liability, damage, loss,
cost (including reasonable attorneys' fees) and expense resulting from any
infringement, claim of bodily injury or property damage (a) relating to the
development, manufacture, use, distribution or sale of any Product by Dendreon,
its Affiliates, Sublicensees, employees or agents or (b) due to the negligence
or willful misconduct of Dendreon or its Affiliates, Sublicensees, employees or
agents.
ARTICLE 13
MISCELLANEOUS
13.1 Assignment. Neither Party shall assign any of its rights and
obligations hereunder except (i) as incident to the merger, consolidation,
reorganization or acquisition of stock affecting actual voting control or of
substantially all of the assets of the assigning Party or (ii) to an Affiliate;
provided, however, that in no event shall either Party's rights and obligations
hereunder be assigned without prior written notice to the other Party. In any
case, neither Party may make an assignment of its assets which renders it unable
to perform its material obligations hereunder. This Agreement shall be binding
upon and inure to the benefit of the Parties hereto and their permitted
successors and assigns.
13.2 Retained Rights. Nothing in this Agreement shall limit in any
respect the right of either Party to conduct research and development with
respect to, and market products outside of, the Field using such Party's
Technology, but no license to use the other Party's technology to do so is
granted herein expressly or by implication.
13.3 Force Majeure. Neither Party shall lose any rights hereunder or be
liable to the other Party for damages or losses on account of failure of
performance by the defaulting Party if
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
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the failure is occasioned by government action, war, fire, explosion, flood,
strike, lockout, embargo, act of God, or any other similar cause beyond the
control of the defaulting Party, provided that the Party claiming force majeure
has exerted all reasonable efforts to avoid or remedy such force majeure;
provided, however, in no event shall a Party be required to settle any labor
dispute or disturbance.
13.4 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 this
Agreement.
13.5 No Trademark Rights. Except as otherwise provided herein, no right,
express or implied, is granted by the Agreement to use in any manner the name
"Dendreon" or "Kirin" or any other trade name or trademark of the other Party in
connection with the performance of the Agreement.
13.6 Notices. All notices and other communications hereunder shall be in
writing and shall be deemed given if delivered personally or by facsimile
transmission (receipt verified), telexed, mailed by registered or certified mail
(return receipt requested), postage prepaid, or sent by express courier service,
to the Parties at the following addresses (or at such other address for a Party
as shall be specified by like notice; provided, that notices of a change of
address shall be effective only upon receipt thereof):
If to Dendreon, addressed to:
Dendreon Corporation
000 Xxxxx Xxxxxxxx Xxxxxx
Xxxxxxxx Xxxx, XX 00000
Attention: X. X. Xxxxxx
Telephone: (000) 000-0000
Telecopy: (000) 000-0000
With copy to:
Xxxxxx Godward LLP
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
00
Xxxx Xxxx Xxxx Xxxxxx, 0xx Xxxxx
Xxxx Xxxx, XX 00000
Attention: Xxxxxxx X. Xxxx, Esq.
Telephone: (000) 000-0000
Telecopy: (000) 000-0000
If to Kirin, addressed to:
Kirin Brewery Co., Ltd.
00-0, Xxxxxxxx 0-xxxxx
Xxxxxxx-xx
Xxxxx 000-0000, Xxxxx
Attention: Xxxxxxx Xxxxxxxxx
Research and Product Development Department
Pharmaceutical Division
Telephone: (00) 0000-0000
Telecopy: (00) 0000-0000
13.7 Dispute Resolution. If any dispute, controversy or claim arises out
of or in connection with this Agreement, the Parties shall use reasonable
efforts to settle it by friendly negotiation within sixty (60) days of notice
from one Party to the other of such dispute, controversy or claim, before
pursuing any other remedies available to them. If either Party fails or refuses
to participate in such negotiations, or if, in any event, the dispute,
controversy or claim is not resolved to the satisfaction of both Parties within
the sixty (60) day period, any such dispute, controversy or claim shall be
settled by arbitration. Any such arbitration shall be conducted in accordance
with the Japan-American Trade Arbitration Agreement of September 16, 1952. The
Parties agree that any such arbitration shall be conducted in the English
language in a location within the United States selected by the Party that did
not initiate such arbitration, and the Agreement shall be governed by and
construed in accordance with the laws of the State of California and the United
States of America. The arbitrators shall include one independent, un-affiliated
nominee selected by each Party and a third neutral arbitrator selected by such
nominees. The Parties agree that any arbitration panel shall include members
knowledgeable as to the evaluation of biopharmaceutical technology. Judgment
upon the award rendered may be entered in the highest state or federal court or
forum, state or federal, having jurisdiction; provided, however, that the
provisions of this Section 13.7 shall not apply to any dispute or
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EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
37
controversy as to which any treaty or law prohibits such arbitration. The
prevailing Party shall be entitled to reasonable attorney's fees and costs to be
fixed by the arbitrators.
13.8 Waiver. Except as specifically provided for herein, the waiver from
time to time by either of the Parties of any of their rights or their failure to
exercise any remedy shall not operate or be construed as a continuing waiver of
same or of any other of such Party's rights or remedies provided in this
Agreement.
13.9 Severability. If any term, covenant or condition of this Agreement
or the application thereof to any Party or circumstance shall, to any extent, be
held to be invalid or unenforceable, then the remainder of this Agreement, or
the application of such term, covenant or condition to Parties or circumstances
other than those as to which it is held invalid or unenforceable, shall not be
affected thereby and each term, covenant or condition of this Agreement shall be
valid and be enforced to the fullest extent permitted by law.
13.10 Ambiguities. Ambiguities, if any, in this Agreement shall not be
construed against any Party, irrespective of which Party may be deemed to have
authored the ambiguous provision.
13.11 Entire Agreement. This Agreement sets forth all the covenants,
promises, agreements, warranties, representations, conditions and understandings
between the Parties hereto with regard to the subject matter discussed herein
and supersedes and terminates all prior agreements and understanding between the
Parties with regard to the subject matter discussed herein. There are no
covenants, promises, agreements, warranties, representations conditions or
understandings, either oral or written, between the Parties with regard to the
subject matter discussed herein other than as set forth in this Agreement;
provided that the Parties agree that the Kirin/Dendreon Term Sheet provides
terms for a collaboration program, to be set forth in a Research and License
Agreement to be negotiated and executed by the Parties consistent with such
terms, for joint development and commercialization in the Joint Territory, to be
set forth in a Commercialization Agreement to be negotiated and executed by the
Parties consistent with such terms, and for the manufacture and supply of
products, to be set forth in a Manufacturing and Supply Agreement to be
negotiated and executed by the Parties consistent with such terms.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
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No subsequent alteration, amendment, change or addition to this Agreement shall
be binding upon the Parties hereto unless reduced to writing and signed by the
respective authorized officers of the Parties.
13.12 Headings. The Section and Paragraph headings contained herein are
for the purposes of convenience only and are not intended to define or limit the
contents of the Section or Paragraphs to which they apply.
IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate
originals by their proper officers as of the date and year first above written.
DENDREON CORPORATION KIRIN BREWERY CO., LTD.
By: /s/ Xxxxxxxxxxx X. Xxxxxx By: /s/ Xxxxxxxx Xxxxxxx
------------------------------------- -------------------------------------
Title: Chief Executive Officer 12/7/98 Title: President, Pharm. Div. 12/10/98
------------------------------------ --------------------------------------
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
39
EXHIBIT A
DENDREON KNOW-HOW
Dendreon "Know-How" would also relate to information (clinical protocols, Batch
Record, SOP's, Release Specifications, minutes from meetings, and other Dendreon
documents) that was discussed and memorialized at previous Kirin-Dendreon
Meetings. Dendreon "Know-How" would include information such as the following:
[*]
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
1.
EXHIBIT B
DENDREON PATENTS
[ * ]
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
1.
EXHIBIT C
KIRIN PATENTS
None as of the Effective Date.
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
1.
EXHIBIT D
TRADEMARK RIGHTS
1. Kirin Licensed Marks
The following trademarks are the subject of the foregoing license:
Word Marks:
Stylized Marks:
2. Kirin Trademark Applications
Xxxx Application No. Application Date
---- --------------- ----------------
3. Dendreon Licensed Marks
The following trademarks are the subject of the foregoing license:
Word Marks:
Stylized Marks:
4. Dendreon Trademark Registrations and Applications
Xxxx Registration No. Registration Date
---- ---------------- -----------------
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BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
1.
5. Forms of Authorized Use of Kirin Trademarks
6. Forms of Authorized Use of Dendreon Trademarks
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS
AMENDED.
2.
