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CONFIDENTIAL TREATMENT REQUESTED EXHIBIT 10.10
CONFIDENTIAL TREATMENT REQUESTED: PAGES WHERE CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED ARE MARKED "CONFIDENTIAL TREATMENT REQUESTED" AND APPROPRIATE
SECTIONS, WHERE TEXT HAS BEEN OMITTED, ARE NOTED WITH "[CONFIDENTIAL TREATMENT
REQUESTED]." AN UNREDACTED VERSION OF THIS DOCUMENT HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION.
COLLABORATIVE DEVELOPMENT AGREEMENT
TAISHO PHARMACEUTICAL CO., LTD. - IDEC PHARMACEUTICALS CORPORATION
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TABLE OF CONTENTS
PAGE
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ARTICLE 1--DEFINITIONS...................................................... 1
ARTICLE 2--RESEARCH AND DEVELOPMENT......................................... 6
ARTICLE 3--OF RESEARCH AND DEVELOPMENT...................................... 11
ARTICLE 4--RIGHTS........................................................... 14
ARTICLE 5--EXCHANGE OF INFORMATION AND CONFIDENTIALITY...................... 14
ARTICLE 6--PATENTS AND PATENT PROSECUTION................................... 16
ARTICLE 7--PRODUCT SUPPLY................................................... 19
ARTICLE 8--REVERSIONS TO IDEC............................................... 20
ARTICLE 9--TERM AND TERMINATION............................................. 20
ARTICLE 10--RIGHTS AND DUTIES UPON TERMINATION.............................. 22
ARTICLE 11--WARRANTIES, REPRESENTATIONS, INSURANCE AND INDEMNIFICATIONS..... 23
ARTICLE 12--FORCE MAJEURE................................................... 25
ARTICLE 13--GOVERNING LAW................................................... 26
ARTICLE 14--DISPUTE RESOLUTION.............................................. 26
ARTICLE 15--SEPARABILITY.................................................... 27
ARTICLE 16--ENTIRE AGREEMENT................................................ 27
ARTICLE 17--NOTICES......................................................... 27
ARTICLE 18--ASSIGNMENT...................................................... 28
ARTICLE 19--RECORDATION..................................................... 28
ARTICLE 20--IN COUNTERPARTS................................................. 28
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APPENDIX TABLE
APPENDIX A: PATENTS..................................................... i
APPENDIX B: ANTIBODY RESEARCH:.......................................... ii
APPENDIX C: PRODUCT DEVELOPMENT......................................... iv
APPENDIX D: MANUFACTURING PROCESS....................................... ix
APPENDIX E: PRODUCT DEVELOPMENT PLAN FOR TAISHO TERRITORY............... xi
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COLLABORATIVE DEVELOPMENT AGREEMENT
This COLLABORATIVE DEVELOPMENT AGREEMENT ("CDA"), effective this 22nd day
of December, 1999 ("EFFECTIVE DATE"), between Taisho Pharmaceutical Co., Ltd.
organized under Japanese law and having its principal executive offices at 00-0
Xxxxxx 0-xxxxx, Xxxxxxx-xx, Xxxxx 000-0000, Xxxxx ("TAISHO") and IDEC
Pharmaceuticals Corporation, a company organized under the laws of the State of
Delaware and having its principal executive offices at 00000 Xxxxxxxxx Xxxx, Xxx
Xxxxx, Xxxxxxxxxx 00000, XXX ("IDEC").
BACKGROUND
WHEREAS, IDEC is engaged in research and development of Macrophage
Migration Inhibitory Factor ("MIF") and has accumulated knowledge relating to
antibody based products;
WHEREAS, both TAISHO and IDEC desire to collaborate in both the research of
antibodies against MIF and in the development of the PRODUCT (hereinafter
defined);
WHEREAS, IDEC acquired rights to develop and manufacture MIF technology
from Cytokine Networks, Inc. ("CNI").
WHEREAS, the PARTIES have entered into the LICENSE AGREEMENT as of even
date, providing for commercialization and marketing of the PRODUCT by both
TAISHO and IDEC in their respective territories. The PARTIES shall also consider
CO-PROMOTION (hereinafter defined) the PRODUCT in TAISHO TERRITORY-B.
NOW, THEREFORE, in consideration of the covenants and obligations expressed
herein, and intending to be legally bound by such covenants and obligations, and
otherwise to be bound by proper and reasonable conduct, the PARTIES agree as
follows:
ARTICLE 1--DEFINITIONS
"AFFILIATES" shall mean any corporation, firm, partnership or other entity,
whether de jure or de facto, which directly or indirectly owns, is owned by or
is under common ownership with a PARTY to this CDA to the extent of at least
fifty percent (50%) of the equity (or such
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lesser percentage which is the maximum allowed to be owned by a foreign
corporation in a particular jurisdiction) having the power to vote on election
of the directors thereof or direct the affairs of the entity and any person,
firm, partnership, corporation or other entity actually controlled by,
controlling or under common control with, a PARTY to this CDA.
"ANTIBODY RESEARCH" shall mean the collaborative research program between
IDEC and TAISHO to develop high affinity humanized monoclonal antibodies in the
FIELD as the PARTIES may agree to in accordance with ARTICLE 2 of this CDA and
as outlined in APPENDIX B hereto.
"BEST EFFORTS" shall mean the maximum effort consistent with the rational
and prudent exercise of business judgment for a commercial enterprise in the
biopharmaceuticals or pharmaceuticals industry. For example, a measure of BEST
EFFORTS shall be not less than the effort accorded a project of high priority
which results from the in-house research of a PARTY to this CDA.
"CDA INFORMATION" shall mean any and all proprietary or confidential data,
information, know-how and results obtained from the ANTIBODY RESEARCH and
PRODUCT DEVELOPMENT as further described in ARTICLE 2 of this CDA.
"CO-PROMOTION" shall mean, for purposes of this CDA, a way of collaboration
by the PARTIES under which TAISHO, it's AFFILIATE or it's sublicensee as one
PARTY and IDEC or it's AFFILIATE as the other PARTY, shall each deploy its own
sales force to market the FINISHED PRODUCT under the same tradename or
trademark, both PARTIES jointly promote the FINISHED PRODUCT in the same country
and in the same FIELD, which is implemented for any country in TAISHO
TERRITORY-B if IDEC determines to do so having exercised it's option under
Section 2.03 of the LICENSE AGREEMENT.
"EMEA" shall mean the European Medicines Evaluation Agency.
"FDA" shall mean the United States Food and Drug Administration.
"FIELD" shall mean use of the PRODUCT(S) for in vivo therapy of human
disease and in vivo diagnosis and in vitro diagnosis and evaluation of
[CONFIDENTIAL TREATMENT REQUESTED].
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"IDEC TECHNOLOGY" shall mean all IDEC KNOW-HOW and PATENTS which relate to
PRODUCT or REAGENT, that IDEC owns, or controls, in whole or in part, and to
which IDEC has the right to use, grant licenses or sublicenses and developed
during the term of this CDA or known to IDEC as of the EFFECTIVE DATE of this
CDA.
"IDEC TERRITORY" shall mean the entire world, except TAISHO TERRITORY.
"IND" shall mean Investigational New Drug application filed with the
medical regulatory authority in any country within the TERRITORY.
"IND ALLOWANCE" shall mean the allowance by the medical regulatory
authority in any country within the TERRITORY to begin human clinical trials as
a result of the submission of an IND for PRODUCT.
"KNOW-HOW" shall mean all proprietary or confidential information, data and
know-how which relates to PRODUCT and shall include, without limitation, all
chemical, pharmacological, toxicological, clinical, assay, quality control and
manufacturing data and any other information and REAGENTS relating to PRODUCT
and useful or required for the ANTIBODY RESEARCH and PRODUCT DEVELOPMENT,
developed during the term of this CDA or known as of the EFFECTIVE DATE, to the
extent that a PARTY is free to disclose, use, license, or sublicense such as
provided by this CDA. In addition, the term "KNOW-HOW" shall include CDA
INFORMATION.
"LICENSE AGREEMENT" shall mean the License Agreement between the PARTIES of
even date.
"MAJOR EUROPEAN COUNTRY" shall mean any one of the following countries:
[CONFIDENTIAL TREATMENT REQUESTED].
"PARTY" shall mean IDEC or TAISHO, as the case may be; "PARTIES" shall mean
IDEC and TAISHO.
"PATENTS" shall mean all patents and patent applications which are or
become owned or controlled by a PARTY or PARTIES jointly, and which such PARTY
or PARTIES otherwise
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have, now or in the future, the right to use, grant licenses or sublicenses
during the term of this CDA, which generically or specifically claim PRODUCT or
REAGENT, a process for manufacturing PRODUCT or REAGENT, an intermediate used in
such process, a method to formulate or deliver PRODUCT or REAGENT or a use of
PRODUCT or REAGENT. Included within the definition of PATENTS are any
continuations, continuations-in-part, divisions, patents of addition, reissues,
renewals or extensions thereof. Also included within the definition of PATENTS
are any patents or patent applications which generically or specifically claim
any improvements on PRODUCT or REAGENT, including the use of PRODUCT or REAGENT,
or intermediates or manufacturing processes required or useful for production of
PRODUCT or REAGENT which are developed by a PARTY or PARTIES, or which such
PARTY or PARTIES otherwise has the right to use, grant licenses, now or in the
future, during the term of this CDA. The current list of patent applications and
patents encompassed within IDEC's PATENTS is set forth in APPENDIX A attached
hereto. APPENDIX A shall be updated by the PARTIES from time to time.
"PIVOTAL TRIAL" shall mean the Registration Trial as used in the United
States in regard to FDA procedure the status of which is equivalent to Phase III
clinical studies as required under the Pharmaceutical Affairs Law in Japan.
"PRODUCT" shall mean any composition of matter, the intellectual property
rights to which are owned in whole or in part by the PARTY, and to which either
PARTY has the right to grant a right to the other PARTY to perform the research
and development of the PRODUCT in accordance with ARTICLE 4 of this CDA as of
the EFFECTIVE DATE or acquires such right during the term of this CDA, which
composition of matter contains antibodies against MIF.
"PRODUCT DEVELOPMENT" shall mean the preclinical and clinical development
program on a PRODUCT within the FIELD conducted during the term of this CDA or
any extensions thereof under Section 9.01 primarily with the intent and purpose
of generating data for submission to a regulatory authority in the TAISHO
TERRITORY, in the case of TAISHO, and in the IDEC TERRITORY, in the case of
IDEC, in support of an application for governmental approval required for
commercializing PRODUCT for any indication. Such
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development program shall be as carried out in accordance with ARTICLE 2 and
APPENDIX C.
"REAGENT" shall mean the determinant of antibodies against MIF, cell lines
expressing such antibodies and other compositions of matter, such as, but not
limited to, the transfected cell lines expressing the PRODUCT, necessary or
useful to develop or produce PRODUCT ."TAISHO TECHNOLOGY" shall mean all TAISHO
KNOW-HOW and PATENTS which relate to PRODUCT or REAGENT, that TAISHO owns, or
controls, in whole or in part, and to which TAISHO has the right to use, grant
licenses or sublicenses and developed during the term of this CDA or known to
TAISHO as of the EFFECTIVE DATE of this CDA.
"TAISHO TERRITORY" shall mean both TAISHO TERRITORY-A and TAISHO
TERRITORY-B, collectively.
"TAISHO TERRITORY-A" shall mean Japan, People's Republic of China, Hong
Kong, Republic of Korea, Singapore, Republic of China (Taiwan), Thailand,
Indonesia, Philippines, Malaysia, India, Cambodia, Vietnam, Pakistan, Sri Lanka,
Democratic People's Republic of Korea, Nepal, Bangladesh, Bhutan, Brunei,
Myanmar, Macao, Maldives, Mongolia, Laos People's Democratic Republic and all
territories and possessions of such countries. If TAISHO's license is terminated
or reverted to IDEC in a particular country pursuant to LICENSE AGREEMENT
Sections 4.01 or 5.05, such country shall be eliminated from the XXXXXX
XXXXXXXXX-X.
"XXXXXX XXXXXXXXX-X" shall mean the United Kingdom, Germany, France, Spain,
Italy, Portugal, Sweden, Switzerland, the Netherlands, Norway, Belgium, Austria,
Denmark, Finland, Australia, New Zealand, Yugoslavia, Romania, Russia
Federation, Slovak Republic, Czech Republic, Hungary, Finland, Bulgaria, Poland,
Helenic Republic, Iceland, Ireland, Albania, Andora, Ukraine, Estonia, Croatia,
San Marino, Slovenia, Vatican, Belarus, Bosnia and Herzegovina, Macedonia,
Malta, Monaco, Moldova, Latvia, Lithuania, Liechtenstein, Luxembourg, Algeria,
Kiribati, Solomon Islands, Tuvalu, Tonga, Nauru, Samoa, Vanuatu, Papua New
Guinea, Palau, Fiji, Xxxxxxxx Islands, Federated States of Micronesia, United
Arab Emirates, Israel, Iraq, Iran, Kuwait, Saudi Arabia, Turkey, Azerbaijan,
Afghanistan, Armenia, Yemen, Uzbekistan, Oman, Kazakhstan, Qatar, Cyprus,
Kyrgyzstan, Georgia, Syria, Tajikistan,
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Turkmenistan, Bahrain, Jordan, Lebanon and all territories and possessions of
such countries. If TAISHO's license is terminated or reverted to IDEC in a
particular country pursuant to LICENSE AGREEMENT Sections 4.01 or 5.05, such
country shall be eliminated from the TAISHO TERRITORY-B."TERRITORY" shall mean
both IDEC TERRITORY and TAISHO TERRITORY, collectively.
"THIRD PARTY(IES)" shall mean any party other than a PARTY to this CDA or
an AFFILIATE of TAISHO or IDEC.
ARTICLE 2--RESEARCH AND DEVELOPMENT
2.01 The PARTIES shall collaborate in the research of antibodies against
MIF and development of a PRODUCT with the objective of (i) [CONFIDENTIAL
TREATMENT REQUESTED], and (ii) [CONFIDENTIAL TREATMENT REQUESTED]. Such research
and development shall consist of two (2) phases: ANTIBODY RESEARCH and PRODUCT
DEVELOPMENT.
(a) The ANTIBODY RESEARCH phase shall commence on the EFFECTIVE DATE
and expire on the occurrence of earlier event of (i) [CONFIDENTIAL TREATMENT
REQUESTED] or (ii) upon [CONFIDENTIAL TREATMENT REQUESTED]. PARTIES shall
through the unanimous vote of the Steering Committee (defined below) and within
[CONFIDENTIAL TREATMENT REQUESTED]. If PARTIES could confirm successful
development thereof, the PRODUCT DEVELOPMENT phase shall automatically commence,
and PARTIES shall confirm when to initiate PRODUCT DEVELOPMENT. In the event
that [CONFIDENTIAL TREATMENT REQUESTED], the PARTIES will discuss and determine
the future direction of this CDA or TAISHO may terminate this CDA with only
those rights and obligations of the Parties set forth in Article 10.
(b) PRODUCT DEVELOPMENT for purposes of this CDA shall be limited to
PRODUCT DEVELOPMENT and commercialization (under LICENSE AGREEMENT) of
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humanized antibodies against the MIF antigen. The PARTIES will collaborate
initially on the development of a first humanized antibody that shall be funded
by the payments made under Article 3 of this CDA. If such first humanized
antibody is later determined by the Steering Committee not to be clinically or
commercially feasible, and is abandoned, the PARTIES will collaborate on
development of a second humanized antibody, the properties of which will be
decided and approved by the Steering Committee, based in part on the experience
and information obtained from the development of the first humanized antibody.
IDEC will not receive additional funding for the development of the second
humanized antibody under this CDA. IDEC shall not be required to develop a third
humanized antibody, regardless of the feasibility of the second antibody. If the
PARTIES agree that development of a first or second humanized antibody requires
the licensing of new technology [CONFIDENTIAL TREATMENT REQUESTED], the PARTIES
shall share equally the license fees and any cash consideration necessary to
secure any such licenses or technology necessary to make a humanized antibody.
2.02 Except as expressly set forth in this CDA (including its Appendices)
and subject to the decision of the Steering Committee, IDEC shall have the
authority to direct and shall jointly carry out with TAISHO the ANTIBODY
RESEARCH and PRODUCT DEVELOPMENT. The general terms regarding the efforts to be
undertaken in furtherance of ANTIBODY RESEARCH and PRODUCT DEVELOPMENT,
including the objectives thereof, have been mutually agreed upon by the PARTIES,
and such agreement is incorporated upon the EFFECTIVE DATE within APPENDIX B and
APPENDIX C of this CDA and is a part thereof which may be amended from time to
time by a mutual agreement of the PARTIES. During the term of this CDA, TAISHO
may send one (1) researcher to IDEC. TAISHO shall be responsible for such
scientist's salary, benefits, living expenses, travel expenses, supply
allowance, etc.
2.03 The PARTIES acknowledge that the collaborative effort under this CDA
involves subjective business and scientific decisions regarding the progress and
direction of the ANTIBODY RESEARCH and PRODUCT DEVELOPMENT, which may require
amending APPENDIX B and APPENDIX C from time to time. To facilitate the ANTIBODY
RESEARCH and PRODUCT DEVELOPMENT, preceding the EFFECTIVE DATE, the PARTIES have
established a committee containing senior research and development members in
equal numbers from both PARTIES ("Steering Committee"), and such Steering
Committee shall,
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in good faith, manage the scientific objectives, and respective activities and
responsibilities of the PARTIES for such ANTIBODY RESEARCH and PRODUCT
DEVELOPMENT, including, but not limited to, the establishment of PRODUCT
profile, time lines, feasibility criteria, protocol design, PRODUCT supply
requirements for research, preclinical and Phase I clinical use, etc., as
outlined in APPENDIX B AND C. Such Steering Committee shall have the authority
to amend APPENDIX B and APPENDIX C from time to time as appropriate. Decisions
by such Steering Committee shall be by unanimous agreement, failing which the
decision shall be made by unanimous agreement of the PARTIES' respective Chief
Executive Officers; failing which the decision shall be mediated or arbitrated
as provided herein.
2.04 The PARTIES shall use BEST EFFORTS to carry out their respective
responsibilities in the ANTIBODY RESEARCH and PRODUCT DEVELOPMENT in their
respective TERRITORIES. TAISHO shall use BEST EFFORTS to initiate PRODUCT
DEVELOPMENT in TAISHO TERRITORY in accordance with its PRODUCT DEVELOPMENT PLAN
for TAISHO TERRITORY (APPENDIX E). Such APPENDIX shall be prepared by TAISHO and
approved by the Steering Committee within one year of the execution of this CDA.
Nevertheless, it is understood that the PARTIES require and shall have
reasonable flexibility in conducting the ANTIBODY RESEARCH and PRODUCT
DEVELOPMENT and in committing their respective resources thereto. If TAISHO
fails to initiate such development in a certain country, TAISHO's licenses under
Article 2 of the LICENSE AGREEMENT to such PRODUCT, including without
limitation, and COMBINATION PRODUCT thereof, shall terminate and the right to
make, have made, use, sell and have sold such PRODUCT or COMBINATION PRODUCT in
such particular country shall revert to IDEC without further obligation of IDEC
to TAISHO for such PRODUCT or COMBINATION PRODUCT in regard to such terminated
country of TAISHO TERRITORY-A or TAISHO TERRITORY-B. TAISHO shall conduct the
research work (under this CDA) by itself and shall not sublicense any rights as
permitted under Article 4 hereunder to any third party during the term of this
CDA, provided that TAISHO may use TAISHO THIRD PARTY defined in Section 2.08 as
a subcontractor for the research on development work under this CDA (i.e.,
research laboratory, etc.).
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2.05 The principal scientists who will direct the respective
responsibilities of each PARTY are, for IDEC: [CONFIDENTIAL TREATMENT REQUESTED]
or his designee, through preclinical development, and upon IND ALLOWANCE,
[CONFIDENTIAL TREATMENT REQUESTED] or his designee, and for TAISHO:
[CONFIDENTIAL TREATMENT REQUESTED] or such other principal scientist later
designated in writing by the relevant PARTY. All CDA INFORMATION disclosed
pursuant to this CDA, and all other communications concerning the ANTIBODY
RESEARCH and PRODUCT DEVELOPMENT, shall be directed to said principal
scientists.
2.06 During the term of this CDA and except as expressly provided for
otherwise herein, neither PARTY shall collaborate on research or development
related to PRODUCT or antibodies or recombinant derivatives of such antibodies
directed against MIF with any THIRD PARTY without the prior written consent of
the other PARTY.
2.07 The REAGENTS, biological materials and/or chemicals provided by one
PARTY to the other under this CDA shall be used in material compliance with all
applicable laws and regulations of the country where they are used. TAISHO and
IDEC each certifies: that it is regularly engaged in conducting tests in vitro
or in animals used only for laboratory research purposes; that all REAGENTS,
biological materials and/or chemicals which either PARTY receives from the other
under this CDA will actually be used for these purposes only; and that no animal
used for such tests will be used for any food purposes or kept as a domestic pet
or livestock.
2.08 Unless and until IDEC exercises its option to CO-PROMOTE in TAISHO
TERRITORY-B, TAISHO shall have full scientific and management authority and
responsibility for the PRODUCT DEVELOPMENT within the TAISHO TERRITORY including
attainment and maintenance of regulatory approvals and price registrations. IDEC
shall have full scientific and management authority and responsibility for the
PRODUCT DEVELOPMENT in the IDEC TERRITORY and if it exercises its option to
CO-PROMOTE in a particular country in TAISHO TERRITORY-B, in such country in
TAISHO TERRITORY-B. Each PARTY will exercise its BEST EFFORTS and diligence in
carrying out its responsibilities in PRODUCT DEVELOPMENT. All such PRODUCT
DEVELOPMENT activity shall be undertaken at TAISHO's expense in TAISHO
TERRITORY-A and TAISHO TERRITORY-B (excluding
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those expenses as shared by IDEC under CO-PROMOTION for any country in TAISHO
TERRITORY-B). Notwithstanding the foregoing, the PARTIES acknowledge the value
of a coordinated and uniformly applied worldwide clinical development plan,
especially as it relates to data reporting and reporting of adverse events. In
preparation for clinical studies, the PARTIES agree to meet and discuss in the
context of the Steering Committee, where appropriate, the design and
implementation of a worldwide clinical development plan.
In addition, PARTIES may discuss and agree upon a collaborative clinical
development agreement for Phase II and Phase III clinical studies relating to
the PRODUCT to be conducted after the expiration of this CDA. Each PARTY shall
report to the other on the status and progress of its efforts to develop PRODUCT
on at least a quarterly schedule, and such report may take the form of a
Steering Committee meeting. The Steering Committee shall meet as required but
not less than at least once every [CONFIDENTIAL TREATMENT REQUESTED] months;
such meetings can be by telephonic communication, written correspondence, or by
face-to-face dialogue as agreed to by the members of the Steering Committee and
the other representatives of both IDEC and TAISHO. In addition, each PARTY shall
report to the other a written summary of results of research and development
work it carries out, if any, [CONFIDENTIAL TREATMENT REQUESTED]. Each PARTY
agrees to prepare and exchange written reports in English language concerning
any results and data that must be used by either PARTY as supporting information
for regulatory filings (e.g., Pre-clinical and clinical study reports, safety
and efficacy data, an IND, and any other reports required to be filed with the
FDA or identified by the FDA as key regulatory documents). Translation from
English language to any other language is made by a PARTY who wishes to have
such translation at its costs. The exchange of such report may be reasonably
supplemented, at the request of the PARTY receiving a report, by correspondence
and/or visits to the other PARTY's facilities.
IDEC shall share with TAISHO and/or TAISHO THIRD PARTY (defined below) all
data generated or acquired related to PRODUCT DEVELOPMENT during the term of
this CDA, provided that TAISHO THIRD PARTY's right to use such data shall be
subject to the same exchange and confidential provision of such agreement.
During the term of this CDA, if IDEC enters into an agreement with a THIRD PARTY
under which IDEC grants such THIRD PARTY (IDEC THIRD PARTY) a license to make,
have made, use or sell any PRODUCT in any country
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in the IDEC TERRITORY, IDEC shall use its BESTS EFFORTS to include in such
agreement exchange of information and confidentiality provisions substantially
equivalent to those of Article 5 of this CDA requiring IDEC THIRD PARTY to share
with TAISHO and/or TAISHO THIRD PARTY free of charge all data IDEC THIRD PARTY
generates or acquires during the term of such agreement related to its
development of such PRODUCT, including, but not limited to, any documents
created for the purposes of regulatory submissions. IDEC THIRD PARTY's data
shall be construed as KNOW-HOW described in Section 4.01, in the light of
relationship between IDEC and TAISHO. On the other hand, TAISHO shall share with
IDEC and/or IDEC THIRD PARTY all data generated or acquired related to PRODUCT
DEVELOPMENT during the term of this CDA, provided that IDEC THIRD PARTY's right
to use such data shall be subject to the same exchange and confidentiality
provision of such agreement. During the term of this CDA, if TAISHO enters into
an agreement with a THIRD PARTY under which TAISHO permits such THIRD PARTY
(TAISHO THIRD PARTY) to use or have used any PRODUCT in any country in the
TAISHO TERRITORY, TAISHO shall use its BEST EFFORTS to include in such agreement
exchange of information and confidentiality provisions substantially equivalent
to those of Article 5 of this CDA requiring TAISHO THIRD PARTY to share with
IDEC and/or IDEC THIRD PARTY free of charge all data TAISHO THIRD PARTY
generates or acquires during the term of such agreement related to its
development of such PRODUCT, including, but not limited to, any documents
created for the purposes of regulatory submissions. TAISHO THIRD PARTY's data
shall be construed as KNOW-HOW described in Section 4.02, in the light of
relationship between IDEC and TASHO.
ARTICLE 3--OF RESEARCH AND DEVELOPMENT
3.01 Fixed Research Funding. TAISHO shall contribute to the funding of the
ANTIBODY RESEARCH costs and expenses incurred or to be incurred at IDEC by
making non-refundable, non-creditable payments to IDEC to reimburse a part of
costs and expenses thereof as follows:
1. Within thirty (30) days from the execution of this CDA [CONFIDENTIAL
TREATMENT
REQUESTED]
2. Within thirty (30) days from the date of first confirmation by the
Steering Committee of a high-affinity antibody that meets joint criteria as
[CONFIDENTIAL
TREATMENT
REQUESTED]
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[CONFIDENTIAL
TREATMENT
defined in APPENDIX C REQUESTED]
3. Within thirty (30) days from the date of first confirmation [CONFIDENTIAL
by the Steering Committee of a high-affinity antibody; TREATMENT
reimbursement of costs related to [CONFIDENTIAL TREATMENT REQUESTED]
REQUESTED] and [CONFIDENTIAL TREATMENT REQUESTED]
3.02 Development Funding. In addition to the payments under Section 3.01,
TAISHO shall fund and reimburse a part of the costs and expenses for the PRODUCT
DEVELOPMENT incurred by IDEC by making non-refundable, non-creditable payments
to IDEC as set forth below.
Flat Quarterly Funding: During the continuance of this CDA, TAISHO shall
make a flat quarterly funding of [CONFIDENTIAL TREATMENT REQUESTED] per quarter
for the first year totaling [CONFIDENTIAL TREATMENT REQUESTED] and [CONFIDENTIAL
TREATMENT REQUESTED] per quarter for the remaining three years totaling
[CONFIDENTIAL TREATMENT REQUESTED] to IDEC commencing within thirty (30) days of
the initiation of the first PRODUCT DEVELOPMENT phase and thereafter within
thirty (30) days of each succeeding calendar quarter as long as this CDA is in
effect, provided that, the aggregate amount of this flat quarterly funding shall
not exceed EIGHTEEN AND A HALF MILLION US dollars (US$ 18,500,000).
These payments shall compensate IDEC for development, preclinical and
clinical expenses related to the primary or back-up humanized anti-MIF antibody
incorporated in any PRODUCT as set forth in APPENDIX B and APPENDIX C. For
back-up anti-MIF antibodies other than those described in APPENDIX B and
APPENDIX C (such as [CONFIDENTIAL TREATMENT REQUESTED]), IDEC will prepare a
development plan with associated development costs and milestone payments, and
the PARTIES will discuss in good faith an amendment to this CDA to include such
costs and milestones. TAISHO may access and use data of the [CONFIDENTIAL
TREATMENT REQUESTED] of any patient who completes treatment by receiving the
last dose of PRODUCT pursuant to the study protocol during the term of this CDA,
without any additional charge. Such data will consist of data listing reports
furnished in hard copy by IDEC. [CONFIDENTIAL TREATMENT REQUESTED], but is not
completed, the PARTIES shall discuss in good faith sharing the costs for
completing such
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study and any and all data will be shared by both PARTIES. If an agreement
cannot be reached between the PARTIES regarding the sharing of costs, there will
be no sharing of data.
3.03 Regarding Sections 3.01 and 3.02 IDEC shall provide TAISHO at the time
of payment or upon request by TAISHO with supporting documents of expenses
incurred by IDEC.
3.04 Consideration. In consideration for rights granted hereunder, TAISHO
shall make the following milestone payments to IDEC as far as this CDA is in
effect at the time of occurrence of the following events:
(a) Within thirty (30) days of the Master Cell Bank Establishment for
the first PRODUCT :
[CONFIDENTIAL TREATMENT REQUESTED]
(b) Within thirty (30) days of IND ALLOWANCE for the first
PRODUCT in the United States:
[CONFIDENTIAL TREATMENT REQUESTED]
TAISHO may withhold any withholding taxes to be imposed on milestone
payments of this Section 3.04 if required by applicable law or regulation and
pay such taxes to an appropriate tax authorities on behalf of IDEC, provided
that TAISHO shall provide IDEC with certificates on the payment of such
withholding taxes.
3.05 Payments. All payments in this Article 3 shall be made in U.S.
dollars.
3.06 The provision of Sections 3.01, 3.02 and 3.04 shall apply to only the
first PRODUCT and to the extent this CDA is effective. in the event that the
first PRODUCT is replaced with new PRODUCT under Section 2.01 (b), payments
which have not been made under Sections 3.01, 3.02 and 3.04 as applicable shall
thereafter apply to such new PRODUCT.
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ARTICLE 4--RIGHTS
4.01 For the purpose of this CDA and subject to the terms hereof, TAISHO
has the royalty free right to use and have used IDEC TECHNOLOGY only to carry
out ANTIBODY RESEARCH and PRODUCT DEVELOPMENT. IDEC grants TAISHO no rights
under this CDA to make or sell PRODUCT; this CDA does not grant a license to
IDEC manufacturing technology; these rights are the subject of the LICENSE
AGREEMENT.
4.02 For the purpose of this CDA and subject to the terms hereof, IDEC has
the royalty free right to use and have used TAISHO TECHNOLOGY to only carry out
ANTIBODY RESEARCH and PRODUCT DEVELOPMENT. TAISHO grants IDEC no rights under
this CDA to make or sell PRODUCT; these rights are the subject of the LICENSE
AGREEMENT.
4.03 This CDA shall not be construed to grant any rights or licenses other
than those specifically and unambiguously permitted hereunder.
ARTICLE 5--EXCHANGE OF INFORMATION AND CONFIDENTIALITY
5.01 During the term of this CDA, each PARTY shall promptly disclose to
and/or supply the other PARTY with its KNOW-HOW to the extent reasonably
necessary to enable the other PARTY to carry out ANTIBODY RESEARCH and PRODUCT
DEVELOPMENT, where applicable. Under no circumstances, however, will IDEC be
obligated to transfer its manufacturing technology hereunder.
5.02 The PARTIES recognize that the holder of a drug approval application
may be required to submit information and file reports to various governmental
agencies on PRODUCT under clinical investigation, PRODUCT proposed for
marketing, or marketed PRODUCT. Information must be submitted at the time of
initial filing for investigational use in humans and at the time of a request
for market approval of a new drug. In addition, supplemental information must be
provided on PRODUCT at periodic intervals and adverse drug experiences must be
reported at more frequent intervals depending on the severity of the experience.
Consequently, each PARTY agrees to establish a joint written pharmacovigilence
policy that complies with the International Committee for Harmonization
guidelines.
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5.03 The PARTIES agree throughout the duration of this CDA to maintain
records and otherwise establish procedures to assure material compliance with
all regulatory, professional or other legal requirements which apply to the
development, promotion and marketing of PRODUCT.
5.04 Neither TAISHO nor IDEC may, during the term of this CDA and for a
period of [CONFIDENTIAL TREATMENT REQUESTED] after the later date of expiration
or termination of this CDA, disclose or reveal to THIRD PARTIES any KNOW-HOW
received from the other PARTY or otherwise developed by either PARTY in the
performance of activities in furtherance of this CDA, except that such other
PARTY may use or disclose such confidential information for the purposes of
investigating, developing, manufacturing, marketing or seeking partners for
PRODUCT in their respective TERRITORY or for securing essential or desirable
authorizations, privileges or rights from governmental agencies, or is required
to be disclosed to a governmental agency or is necessary to file or prosecute
patent applications concerning PRODUCT or to carry out any litigation concerning
PRODUCT. This confidentiality obligation shall not apply to such information
which is or becomes a matter of public knowledge, or came or comes into the
possession of the receiving PARTY independently of this CDA (unless otherwise
disclosed confidentially at any time by TAISHO to IDEC or IDEC to TAISHO), or is
disclosed to the receiving PARTY by a THIRD PARTY having the right to do so, or
is subsequently and independently developed by employees of the receiving PARTY
or AFFILIATES thereof who had no knowledge of the KNOW-HOW disclosed and can be
so demonstrated by competent proof. The PARTIES shall take reasonable measures
to ensure that no unauthorized use or disclosure is made by others to whom
access to KNOW-HOW is granted.
The PARTIES agree that the formal initiation or early termination of this
collaboration as evidenced by the terms of this CDA may constitute "material
information" for IDEC or TAISHO that must be disclosed to the public and IDEC's
or TAISHO's shareholders via a press release. A draft press release regarding
the initiation of the PRODUCT DEVELOPMENT phase shall be prepared by IDEC or
TAISHO and reviewed in good faith and approved by IDEC and TAISHO concurrently
with the review and approval of the Steering Committee of a high-affinity
antibody or anytime thereafter. No public announcement or other disclosure to
THIRD PARTIES concerning the terms of this CDA shall be made, either directly or
indirectly, by either PARTY
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to this CDA, except as may be legally required, or seeking partners for PRODUCT
in their respective TERRITORY as prescribed in Section 2.08 above, without first
obtaining the written approval of the other PARTY and agreement upon the nature
of such announcement or disclosure, provided that such approval shall not be
unreasonably withheld. The PARTY desiring to make any such public announcement
or other disclosure shall use BEST EFFORTS to inform the other PARTY of the
proposed announcement or disclosure in reasonably sufficient time prior to
public release, and shall use BEST EFFORTS to provide the other PARTY with a
written copy thereof, in order to allow such other PARTY to comment upon such
announcement or disclosure.
5.05 The PARTIES acknowledge the importance of written publications and
oral presentation of scientific and clinical findings emanating from ANTIBODY
RESEARCH and PRODUCT DEVELOPMENT, and the role they play in furthering the
objectives of the PARTIES; provided however, that such publications or
presentations are done in a manner reasonably consistent with the protection of
either PARTY's TECHNOLOGY. Accordingly, neither TAISHO nor IDEC shall submit for
written, electronic or oral publication any manuscript, abstract or the like,
which includes data or other information generated or provided by the other
PARTY in the course of, or otherwise as a result of, ANTIBODY RESEARCH or
PRODUCT DEVELOPMENT or otherwise related to PRODUCT, without first obtaining the
prior written consent of such other PARTY, which consent shall not be
unreasonably withheld. The contribution of each PARTY shall be noted in all
publications or presentations by acknowledgment or co-authorship, whichever is
appropriate.
5.06 Nothing in this CDA shall be construed as preventing or in any way
inhibiting either PARTY from complying with statutory and regulatory
requirements governing the manufacture, use and sale or other distribution of
PRODUCT in any manner it reasonably deems appropriate, including, for example,
by disclosing to regulatory authorities confidential or other information
received from each other or THIRD PARTIES.
ARTICLE 6--PATENTS AND PATENT PROSECUTION
6.01 Each PARTY shall have and retain sole and exclusive title to all
inventions, discoveries and patentable CDA INFORMATION which are made,
conceived, reduced to
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practice and generated solely by its employees or agents in the course of or as
a result of the ANTIBODY RESEARCH or PRODUCT DEVELOPMENT. IDEC and TAISHO shall
own a fifty percent (50%) undivided interest in all inventions, discoveries and
patentable CDA INFORMATION made, conceived, reduced to practice or generated
jointly by employees or agents of both PARTIES in the course of or as a result
of the ANTIBODY RESEARCH or PRODUCT DEVELOPMENT. Inventorship of invention,
discoveries and patentable CDA INFORMATION shall be subject to and determined by
the patent laws of the country where the patent applications are filed.
6.02 (a) Upon the making, conceiving or reducing to practice of any
invention or discovery by a PARTY as referred to in Section 6.01, within a
reasonable period of time to take appropriate protection measures for such
invention or discovery, such PARTY shall provide the other PARTY with a written
summary in the English language of such invention or discovery.
(i) IDEC shall have the first right, using in-house or outside
legal counsel selected at IDEC's sole discretion, to prepare, file, prosecute,
maintain and extend PATENTS concerning all such inventions and discoveries owned
in whole or in part by IDEC in countries of IDEC's choice throughout the world,
with appropriate credit to TAISHO representatives, including the naming of such
parties as inventors, where appropriate, for which IDEC shall bear the costs
relating to such activities which occur at IDEC's request or direction. IDEC
shall use BEST EFFORTS to solicit TAISHO's advice and review of the nature and
text of such patent applications and material prosecution matters related
thereto in reasonably sufficient time prior to filing thereof, and IDEC shall
take into account TAISHO's reasonable comments related thereto. Upon
presentation of an itemized invoice detailing IDEC's expenses, TAISHO shall
promptly reimburse IDEC for the reasonable out-of-pocket costs IDEC incurs in
filing, prosecuting and maintaining such PATENTS in the TAISHO TERRITORY-A and
in a country of TAISHO TERRITORY-B where IDEC does not elect a co-exclusive
license, and for one-half of the reasonable out-of-pocket costs IDEC incurs in
the country of TAISHO TERRITORY-B which IDEC elects a co-exclusive license.
TAISHO shall hold all information disclosed to it under this Section as
confidential subject to the provisions of ARTICLE 5 of this CDA. Unless IDEC
desires to maintain the subject matter of such PATENTS as a trade secret, TAISHO
shall at its full discretion have the right to assume responsibility for any
such PATENT or any part of
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any such PATENT which IDEC intends to abandon or otherwise cause or allow to be
forfeited. IDEC shall diligently prosecute and maintain such PATENTS in the
TERRITORY. Notwithstanding foregoing any and all activities of filing,
prosecuting and maintaining PATENTS jointly owned by the PARTIES shall be made
by an agreement of PARTIES.
(ii) TAISHO shall have the first right, using in-house or outside
legal counsel selected at TAISHO's sole discretion, to prepare, file, prosecute,
maintain and extend PATENTS concerning all such inventions and discoveries owned
in whole by TAISHO in countries of TAISHO's choice within the TERRITORY, for
which TAISHO shall bear the costs relating to such activities. TAISHO shall use
BEST EFFORTS to solicit IDEC's advice and review of the nature and text of such
PATENTS and material prosecution matters related thereto in reasonably
sufficient time prior to filing thereof, and TAISHO shall take into account
IDEC's reasonable comments related thereto. IDEC shall reimburse TAISHO for the
reasonable out-of-pocket costs TAISHO incurs in filing, prosecuting and
maintaining such PATENTS in the IDEC TERRITORY. IDEC shall hold all information
disclosed to it under this Section as confidential subject to the provisions of
ARTICLE 5 of this CDA. Unless TAISHO desires to maintain the subject matter of
such PATENTS as a trade secret, IDEC shall at its full discretion have the right
to assume responsibility for any such PATENT or any part of any such PATENT
which TAISHO intends to abandon or otherwise cause or allow to be forfeited.
TAISHO shall diligently prosecute and maintain such PATENTS in the TERRITORY.
(b) If IDEC, prior or subsequent to filing certain PATENTS on such
inventions or discoveries which are owned in whole by IDEC or in part by TAISHO,
elects not to maintain the subject matter of such PATENTS as a trade secret and
elects not to prosecute or maintain such PATENTS or certain claims encompassed
by such PATENTS, IDEC shall give TAISHO notice thereof within a reasonable
period prior to allowing such PATENTS or such certain claims encompassed by such
PATENTS to lapse or become abandoned or unenforceable, and TAISHO shall at its
full discretion thereafter have the right, at its sole expense, to prepare,
file, prosecute and maintain such PATENTS or divisional applications related to
such certain claims encompassed by such PATENTS concerning all such inventions
and discoveries in countries of its choice throughout the world. If TAISHO,
prior or subsequent to filing PATENTS on such inventions or discoveries which
are owned in whole by TAISHO, elects not
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to maintain the subject matter of such PATENTS as a trade secret and elects not
to prosecute or maintain such PATENTS or certain claims encompassed by such
PATENTS, TAISHO shall give IDEC notice thereof within a reasonable period prior
to allowing such PATENTS or such certain claims encompassed by such PATENTS to
lapse or become abandoned or unenforceable, and IDEC shall at its full
discretion thereafter have the right, at its sole expense, to prepare, file,
prosecute and maintain such PATENTS or divisional applications related to such
certain claims encompassed by such PATENTS concerning all such inventions and
discoveries in countries of its choice throughout the world
The PARTY filing PATENTS for jointly owned inventions and discoveries shall
do so in the name of and on behalf of both TAISHO and IDEC.
6.03 Notwithstanding the provisions of Section 6.02 of this CDA, each PARTY
shall, at its own expense, provide reasonable assistance to the other PARTY to
facilitate filing of all PATENTS covering inventions referred to in Section 6.01
of this CDA and shall execute all documents deemed necessary or desirable
therefor.
ARTICLE 7--PRODUCT SUPPLY
7.01 During the term of this CDA and that of LICENSE AGREEMENT, IDEC shall
manufacture, at TAISHO's request and [CONFIDENTIAL TREATMENT REQUESTED], and
supply to TAISHO its requirements of PRODUCT manufactured under GMP guidelines
for preclinical studies including safety studies, and clinical trials in the
TERRITORY. The amount of PRODUCT requested by TAISHO must be reasonably related
to requirements for conducting such studies under the appropriate protocols,
with an appropriate lead-time no less than [CONFIDENTIAL TREATMENT REQUESTED]
provided to IDEC and such requirements shall not exceed [CONFIDENTIAL TREATMENT
REQUESTED] on an assumption that such amount is enough to cover necessary
requirements for such studies. IDEC shall establish cell lines, manufacture and
set specifications in accordance with applicable FDA, KOSEISHO, and EMEA
guidelines; however, if additional development expense is required to meet
KOSEISHO's or EMEA's guidelines, TAISHO agrees to reimburse IDEC for such
additional expenses at reasonable price to be agreed upon between the PARTIES
taking IDEC's
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allocated cost into consideration. IDEC shall attempt to deliver such PRODUCT
within [CONFIDENTIAL TREATMENT REQUESTED] from TAISHO and using IDEC's BEST
EFFORTS.
ARTICLE 8--REVERSIONS TO IDEC
8.01 If TAISHO, in its sole discretion, elects to abandon, discontinue, or
forego development of any PRODUCT for all indications of such PRODUCT within the
TAISHO TERRITORY-A, or TAISHO TERRITORY-B, TAISHO shall give IDEC written notice
to that effect and TAISHO's right under ARTICLE 4 in regard to XXXXXX
XXXXXXXXX-X xxx/xx XXXXXX XXXXXXXXX-X shall terminate and the rights to develop
shall revert to IDEC, and IDEC shall have no further obligations to TAISHO for
such PRODUCT in regard to such terminated XXXXXX XXXXXXXXX-X xxx/xx XXXXXX
XXXXXXXXX-X.
ARTICLE 9--TERM AND TERMINATION
9.01 This CDA shall come into effect on the EFFECTIVE DATE and, unless
earlier terminated hereunder, shall continue to be in effect until the first to
occur of: (a) [CONFIDENTIAL TREATMENT REQUESTED]; or (b) [CONFIDENTIAL TREATMENT
REQUESTED]. If continued research or development is desirable, the collaboration
may be extended by a separate agreement between the PARTIES, on reasonable terms
and conditions to be negotiated in good faith.
9.02 Following the expiration of this CDA pursuant to Section 9.01 above,
each PARTY shall retain a perpetual and co-exclusive right to carry out research
and development of the PRODUCT to the extent such right is granted to each PARTY
pursuant to ARTICLE 4 hereof.
9.03 If either PARTY materially fails or neglects to perform its
obligations except a case beyond its control set forth in this CDA and if such
default is not corrected within [CONFIDENTIAL TREATMENT REQUESTED] days after
receiving written notice from the other PARTY with respect to such default, such
other PARTY shall have the right to terminate this CDA by giving written notice
to the PARTY in default provided the notice of termination is given within
[CONFIDENTIAL TREATMENT REQUESTED] months of the default and
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prior to correction of the default. In which case terminating PARTY shall have
the right described in Section 9.02 above.
9.04 TAISHO may terminate this CDA in its entirety or with respect to any
country in the TAISHO TERRITORY by giving IDEC at least [CONFIDENTIAL TREATMENT
REQUESTED] days written notice thereof based on a reasonable determination,
using the same standards TAISHO would use in assessing whether or not to
continue development of a product of its own making, that the patent,
medical/scientific, technical, regulatory or commercial profile of PRODUCT does
not justify continued development of PRODUCT. Termination of this CDA with
respect to any country in the TAISHO TERRITORY under this provision shall
terminate all rights and licenses granted to TAISHO in such country under
ARTICLE 4 with full reversion to IDEC of all IDEC's interest and rights in IDEC
TECHNOLOGY in such country and TAISHO shall have no further obligation to IDEC
for such terminated country.
9.05 If the LICENSE AGREEMENT is terminated due to TAISHO's default prior
to the expiration of the term of this CDA, this CDA shall be automatically
terminated and if the LICENSE AGREEMENT is terminated due to IDEC's default,
Section 9.02 hereof shall be applied thereto.
9.06 Either PARTY may terminate this CDA if, at any time, the other PARTY
shall file in any court or agency pursuant to any statute or regulation of any
state or country, a petition in bankruptcy or insolvency or for reorganization
or for an arrangement or for the appointment of a receiver or trustee of the
PARTY or of its assets, or if the other PARTY proposes a written agreement of
composition or extension of its debts, or if the other PARTY shall be served
with an involuntary petition against it, filed in any insolvency proceeding, and
such petition shall not be dismissed within [CONFIDENTIAL TREATMENT REQUESTED]
days after the filing thereof, or if the other PARTY shall propose or be a PARTY
to any dissolution or liquidation, or if the other PARTY shall make an
assignment for the benefit of creditors.
9.07 Notwithstanding the bankruptcy of a PARTY, or the impairment of
performance by a PARTY of its obligations under this CDA as a result of
bankruptcy or insolvency of such PARTY, the non-bankrupt PARTY shall be entitled
to retain the rights granted herein, subject to bankrupt PARTY's rights to
terminate this CDA for reasons other than bankruptcy or insolvency
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as expressly provided in this CDA, and subject to performance by the
non-bankrupt PARTY of its preexisting obligations under this CDA.
ARTICLE 10--RIGHTS AND DUTIES UPON TERMINATION
10.01 Upon termination of this CDA, IDEC shall have the right to retain any
sums already paid by TAISHO hereunder, and TAISHO shall pay all sums accrued
hereunder which are then due.
10.02 Termination of this CDA shall terminate all rights and further
obligations between the PARTIES arising from this CDA, including, but not
limited to, the payment obligations outlined in Sections 3.01, 3.02 and 3.04,
provided, however, those described in the second paragraph of Section 5.04 for
data or other information generated or provided by either PARTY during the term
of this CDA, the first paragraph of Section 5.04, Sections 2.07, 5.02, 5.03,
5.05, 5.06, 6.01, 9.02 through 9.07 (except 9.06), 10.01, 10.02, 10.03, 10.04
and ARTICLES 7, 11, 13 through 19, and existing rights against the other PARTY
for a breach by that PARTY shall survive any termination of this CDA.
10.03 Termination of this CDA under Section 9.03 for a default by IDEC
shall terminate TAISHO's obligation to make any remaining payments required by
this CDA including ARTICLE 3 for the period effective as of the date IDEC
received written notice from TAISHO with respect to such default if after the
elapse of sixty (60) days from receipt of such notice such default is not
corrected. Termination of this CDA with respect to all countries of the TAISHO
TERRITORY under Section 9.04 shall terminate TAISHO's obligation to make any
remaining payments required by this CDA including ARTICLE 3 for periods after
the effective date of termination.
10.04 All rights to terminate, and rights upon termination, provided for
either PARTY in this CDA are in addition to other remedies in law or equity
which may be available to either PARTY.
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ARTICLE 11--WARRANTIES, REPRESENTATIONS, INSURANCE AND INDEMNIFICATIONS
11.01 As of the EFFECTIVE DATE, IDEC warrants that, to the best of its
belief and knowledge, it owns the entire right and title to the extent of its
ownership interest in IDEC TECHNOLOGY, or has the right to use, and grant the
license outlined in ARTICLE 4 with respect to IDEC'S TECHNOLOGY, and has the
right to enter into this CDA.
11.02 NOTHING IN THIS CDA SHALL BE CONSTRUED AS A WARRANTY THAT PATENTS ARE
VALID OR ENFORCEABLE OR THAT THE EXERCISE OF SUCH DOES NOT INFRINGE ANY VALID
PATENT RIGHTS OF THIRD PARTIES.
11.03 IDEC warrants and represents that it has no present knowledge of the
existence of any preclinical or clinical data or information concerning the
PRODUCT which suggests that there may exist toxicity, safety and/or efficacy
concerns which may materially impair the utility and/or safety of the PRODUCT.
11.04 Either PARTY (INDEMNIFYING PARTY) shall indemnify and hold harmless
the other PARTY (INDEMNIFIED PARTY), its officers, directors, shareholders,
employees, successors and assigns from any loss, damage, or liability, including
reasonable attorneys' fees, resulting from any claim, complaint, suit,
proceeding or cause of action against any of them alleging physical or other
injury (including, (a) death, brought by or on behalf of an injured party, and
(b) loss of service or consortium or a similar such claim, complaint, suit,
proceeding or cause of action brought by a friend, spouse, relative or companion
of an injured party) due to such physical injury or death and arising out of the
administration, utilization and/or ingestion of PRODUCT used or otherwise
provided, directly or indirectly, to the injured party by INDEMNIFYING PARTY (or
any AFFILIATES or sublicensees); except to the extent such damages, claims,
costs, losses, liabilities or expenses are directly and proximately caused by
INDEMNIFIED PARTY's gross negligence, willful action or inaction and provided:
(a) INDEMNIFYING PARTY shall not be obligated under this Section, if
it is shown by evidence acceptable in a court of law having jurisdiction over
the subject matter and meeting the appropriate degree of proof for such action,
that the injury was the result of the gross negligence or willful misconduct of
any employee or agent of INDEMNIFIED PARTY;
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(b) INDEMNIFYING PARTY shall have no obligation under this Section,
unless:
(i) INDEMNIFIED PARTY gives INDEMNIFYING PARTY prompt written
notice of any claim or lawsuit or other action for which it seeks to be
indemnified under this CDA;
(ii) INDEMNIFYING PARTY is granted full authority and control
over the defense, including settlement, against such claim or lawsuit or other
action; and
(iii) INDEMNIFIED PARTY cooperates fully with INDEMNIFYING PARTY
and its agents in defense of the claims or lawsuit or other action; and
(c) INDEMNIFIED PARTY shall have the right to participate in the
defense of any such claim, complaint, suit, proceeding or cause of action
referred to in this Section utilizing attorneys of its choice, provided,
however, that INDEMNIFYING PARTY shall have full authority and control to handle
any such claim, complaint, suit, proceeding or cause of action, including any
settlement or other disposition thereof, for which INDEMNIFIED PARTY seeks
indemnification under this Section.
11.05 IDEC shall defend, indemnify and hold harmless TAISHO and its
officers, directors, shareholders, employees, successors and assigns from and
against any and all damages, claims, costs, losses, liabilities or expenses
(including reasonable attorneys' fees) arising out of, or resulting from or in
connection with IDEC's or its licensee's activities under this CDA, including,
but not limited to, IDEC's activities related to any breach of a representation
or warranty made to TAISHO by IDEC under this CDA. However, IDEC shall not
defend, indemnify and hold harmless TAISHO and its officers, directors,
shareholders, employees, successors and assigns from and against any and all
damages, claims, costs, losses, liabilities or expenses (including reasonable
attorneys' fees) which are directly and proximately caused by TAISHO's gross
negligence or willful action or inaction which is held in legal proceedings in a
court having jurisdiction. TAISHO shall have the right to participate (at its
own cost) in the defense of any such claim, complaint, suit, proceeding or cause
of action referred to in this Section utilizing attorneys of its choice;
however, IDEC shall have full authority and control to
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handle any such claim, complaint, suit, proceeding or cause of action, including
any settlement or other disposition thereof, for which TAISHO seeks
indemnification under this Section.
11.06 TAISHO shall defend, indemnify and hold harmless IDEC and its
officers, directors, shareholders, employees, successors and assigns from and
against any and all damages, claims, costs, losses liabilities or expenses
(including reasonable attorneys' fees) arising out of, or resulting from or in
connection with TAISHO's or its AFFILIATE's activities under this CDA,
including, but not limited, to any breach of a representation or warranty made
to IDEC by TAISHO under this CDA. However, TAISHO shall not defend, indemnify
and hold harmless IDEC and its officers, directors, shareholders, employees,
successors and assigns from and against any and all damages, claims, costs,
losses, liabilities or expenses (including reasonable attorneys' fees) which are
directly and proximately caused by IDEC's gross negligence or willful action or
inaction which is held in legal proceedings in a court having jurisdiction. IDEC
shall have the right to participate (at its own cost) in the defense of any such
claim, complaint, suit, proceeding or cause of action referred to in this
Section utilizing attorneys of its choice; however, TAISHO shall have full
authority and control to handle any such claim, complaint, suit, proceeding or
cause of action, including any settlement or other disposition thereof, for
which IDEC seeks indemnification under this Section.
11.07 Notwithstanding anything else in this CDA, the LICENSE AGREEMENT or
otherwise, neither PARTY will be liable with respect to any subject matter of
this CDA under any contract, negligence, strict liability or other legal or
equitable theory for any amounts in excess in the aggregate of the amounts
received by IDEC under this CDA and the LICENSE AGREEMENT, for any incidental or
consequential damages, or for cost of procurement of substitute goods,
technology, or services.
ARTICLE 12--FORCE MAJEURE
12.01 If the performance of any part of this CDA by either PARTY, or of any
obligation under this CDA, is prevented, restricted, interfered with or delayed
by reason of any cause beyond the reasonable control of the PARTY liable to
perform, unless conclusive evidence to the contrary is provided, the PARTY so
affected shall, upon giving written notice to the other PARTY, be excused from
such performance to the extent of such prevention, restriction,
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interference or delay, provided that the affected PARTY shall use its BEST
EFFORTS to avoid or remove such causes of non-performance and shall continue
performance with the utmost dispatch whenever such causes are removed. When such
circumstances arise, the PARTIES shall discuss what, if any, modification of the
terms of this CDA may be required in order to arrive at an equitable solution.
ARTICLE 13--GOVERNING LAW
13.01 This CDA shall be governed by the laws of the State of California,
U.S.A.
ARTICLE 14--DISPUTE RESOLUTION
14.01 The PARTIES agree that any legal dispute, controversy or claim
(except as to any issue relating to intellectual property in whole or in part by
IDEC) arising out of or relating to this CDA, or the breach, termination, or
invalidity thereof, shall be resolved through negotiation, mediation and/or
binding arbitration. If a legal dispute arises between the PARTIES, and if said
dispute cannot be resolved after a face-to-face, good faith negotiations in the
U.S the PARTIES agree to first try in good faith to resolve such dispute by
mediation administered by the American Arbitration Association in accordance
with its Commercial Mediation Rules . If efforts at mediation are unsuccessful,
any unresolved controversy or claim between the PARTIES shall be resolved by
binding arbitration in accordance with the Commercial Arbitration Rules of the
American Arbitration Association, except as modified by this Section 14.01. The
arbitration decision shall be binding and not be appealable to any court in any
jurisdiction. The prevailing PARTY may enter such decision in any court having
competent jurisdiction. The arbitration proceeding shall be conducted in the
English language in San Francisco, California. The PARTIES agree that they shall
share equally the cost of the mediation/arbitration filing and hearing fees, and
the cost of the mediator/arbitrator. Each PARTY must bear its own attorney's
fees and associated costs and expenses.
14.02 Notwithstanding anything contained in Section 14.01 to the contrary,
the PARTIES shall have the right to institute judicial proceedings against the
other PARTY or anyone acting through or under the control of the other PARTY in
order to enforce the instituting PARTY's rights hereunder through reformation of
contract, specific performance, injunction, or similar equitable relief.
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ARTICLE 15--SEPARABILITY
15.01 In the event any portion of this CDA shall be held illegal, void or
ineffective, the remaining portions hereof shall remain in full force and
effect.
15.02 If any of the terms or provisions of this CDA are in conflict with
any applicable statute or rule of law, then such terms or provisions shall be
deemed inoperative to the extent that they may conflict therewith and shall be
deemed to be modified to conform with such statute or rule of law.
15.03 In the event that the terms and conditions of this CDA are materially
altered as a result of Sections 15.01 or 15.02, the PARTIES will renegotiate the
terms and conditions of this CDA to resolve any inequities.
ARTICLE 16--ENTIRE AGREEMENT
16.01 This CDA, together with the LICENSE AGREEMENT entered into as of the
EFFECTIVE DATE, constitutes the entire agreement between the PARTIES relating to
the subject matter hereof and supersedes all previous writings and
understandings. No terms or provisions of this CDA shall be varied or modified
by any prior or subsequent statement, conduct or act of either of the PARTIES,
except that the PARTIES may amend this CDA by written instruments specifically
referring to and executed in the same manner as this CDA.
ARTICLE 17--NOTICES
17.01 Any notice required or permitted under this CDA shall be sent by
certified mail or overnight courier service, postage pre-paid to the following
addresses of the PARTIES:
IDEC PHARMACEUTICALS CORPORATION
00000 Xxxxxxxxx Xxxx
Xxx Xxxxx, Xxxxxxxxxx 00000 U.S.A.
Attention: Corporate Secretary
Copy to: President
TAISHO PHARMACEUTICAL CO., LTD.
00-0 Xxxxxx 0-xxxxx, Xxxxxxx-xx
Xxxxx 000-0000, Xxxxx
Attention: Group Manager of Licensing Division
27
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CONFIDENTIAL TREATMENT
ARTICLE 18--ASSIGNMENT
18.01 This CDA and the rights herein granted shall be binding upon and
inure to the benefit of the successors in interest of the respective PARTIES.
Neither this CDA nor any interest hereunder shall be assignable by either PARTY
without the written consent of the other PARTY, provided, however, that either
PARTY may assign this CDA or any PATENT owned by it to any AFFILIATE or to any
corporation with which it may merge or consolidate, or to which it may transfer
all or substantially all of its assets to which this CDA relates, without
obtaining consent but giving notice to the other PARTY.
ARTICLE 19--RECORDATION
19.01 The PARTIES shall have the right, at any time during the term of this
CDA, to record, register, or otherwise notify this CDA in any patent office or
other appropriate facility anywhere in the TERRITORY, and the PARTIES shall
provide reasonable assistance to each other in effecting such recording.
ARTICLE 20--IN COUNTERPARTS
20.01 This CDA may be executed in duplicate, each of which shall be deemed
an original, but all of which together shall constitute one and the same
instrument.
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32
CONFIDENTIAL TREATMENT
IN WITNESS WHEREOF, the PARTIES, through their authorized officers, have
executed this CDA.
TAISHO PHARMACEUTICAL CO., LTD.
By: /s/ Xxxxx Xxxxxx
-------------------------------
Title: President
----------------------------
Date: December 9, 1999
----------------------------
IDEC PHARMACEUTICALS CORPORATION
By: /s/ Xxxxxxx X. Xxxxxxxxx, Ph.D.
-------------------------------
Title: Chairman, President, and Chief Executive Officer
------------------------------------------------
Date: 12/22/99
------------------------------
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CONFIDENTIAL TREATMENT REQUESTED
COLLABORATIVE DEVELOPMENT AGREEMENT
APPENDIX A - PATENTS
-------------------------------------------------------------------------------------------------
U.S. PATENT APPLICATIONS
-------------------------------------------------------------------------------------------------
SERIAL NUMBER FILED CNI DOCKET STATUS
------------------------- ----------------------- ---------------------- ------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED]
------------------------- ----------------------- ---------------------- ------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED]
------------------------- ----------------------- ---------------------- ------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED]
------------------------- ----------------------- ---------------------- ------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED]
------------------------- ----------------------- ---------------------- ------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED]
------------------------- ----------------------- ---------------------- ------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED]
------------------------- ----------------------- ---------------------- ------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED]
------------------------- ----------------------- ---------------------- ------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED]
------------------------- ----------------------- ---------------------- ------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED]
------------------------- ----------------------- ---------------------- ------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED]
------------------------- ----------------------- ---------------------- ------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED]
------------------------- ----------------------- ---------------------- ------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED]
------------------------- ----------------------- ---------------------- ------------------------
-------------------------------------------------------------------------------------------------
FOREIGN PATENT APPLICATION
-------------------------------------------------------------------------------------------------
COUNTRY APPLICATION NO. CNI DOCKET STATUS
------------------------- ----------------------- ---------------------- ------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED]
------------------------- ----------------------- ---------------------- ------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED]
------------------------- ----------------------- ---------------------- ------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED]
------------------------- ----------------------- ---------------------- ------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED]
------------------------- ----------------------- ---------------------- ------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED]
------------------------- ----------------------- ---------------------- ------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED]
------------------------- ----------------------- ---------------------- ------------------------
i
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CONFIDENTIAL TREATMENT REQUESTED
COLLABORATIVE DEVELOPMENT AGREEMENT
APPENDIX B - ANTIBODY RESEARCH
A. GENERATION AND ISOLATION OF [CONFIDENTIAL TREATMENT REQUESTED]
1. Generation of humanized antibodies
The [CONFIDENTIAL TREATMENT REQUESTED] produced by the [CONFIDENTIAL
TREATMENT REQUESTED] were shown to have [CONFIDENTIAL TREATMENT REQUESTED],
although binding to [CONFIDENTIAL TREATMENT REQUESTED]. Antibodies with
[CONFIDENTIAL TREATMENT REQUESTED], however, are required for [CONFIDENTIAL
TREATMENT REQUESTED]. The [CONFIDENTIAL TREATMENT REQUESTED] humanized with an
affinity to [CONFIDENTIAL TREATMENT REQUESTED]. [CONFIDENTIAL TREATMENT
REQUESTED]. [CONFIDENTIAL TREATMENT REQUESTED] it has [CONFIDENTIAL TREATMENT
REQUESTED], after which [CONFIDENTIAL TREATMENT REQUESTED].
[CONFIDENTIAL TREATMENT REQUESTED]:
[CONFIDENTIAL TREATMENT REQUESTED]
[CONFIDENTIAL TREATMENT REQUESTED].
1.2 [CONFIDENTIAL TREATMENT REQUESTED]
[CONFIDENTIAL TREATMENT REQUESTED]. Antibodies with binding
[CONFIDENTIAL TREATMENT REQUESTED] will be selected as candidates for
[CONFIDENTIAL TREATMENT REQUESTED]. [CONFIDENTIAL TREATMENT REQUESTED].
1.3 Construction of humanized antibodies
[CONFIDENTIAL TREATMENT REQUESTED]. [CONFIDENTIAL TREATMENT REQUESTED]
humanized [CONFIDENTIAL TREATMENT REQUESTED] antibody will be modeled onto an
[CONFIDENTIAL TREATMENT REQUESTED]. [CONFIDENTIAL TREATMENT REQUESTED]. The
modeled humanized [CONFIDENTIAL TREATMENT REQUESTED] will then be [CONFIDENTIAL
TREATMENT REQUESTED]. The [CONFIDENTIAL TREATMENT REQUESTED]. The recombinant
humanized [CONFIDENTIAL TREATMENT REQUESTED] will be [CONFIDENTIAL TREATMENT
REQUESTED], [CONFIDENTIAL TREATMENT REQUESTED] and then [CONFIDENTIAL TREATMENT
REQUESTED].
ii
35
CONFIDENTIAL TREATMENT REQUESTED
2. Generation of [CONFIDENTIAL TREATMENT REQUESTED] antibodies
A backup strategy to the humanized [CONFIDENTIAL TREATMENT REQUESTED]
strategy will be to select [CONFIDENTIAL TREATMENT REQUESTED]. This, however,
falls outside the scope of this agreement and should be addressed separately at
the Steering Committee level .
iii
36
CONFIDENTIAL TREATMENT REQUESTED
COLLABORATIVE DEVELOPMENT AGREEMENT
APPENDIX C - PRODUCT DEVELOPMENT
1. Characterization of [CONFIDENTIAL TREATMENT REQUESTED] antibodies
The humanized antibodies described in Appendix B will be tested for
the following criteria in order to [CONFIDENTIAL TREATMENT REQUESTED]:
[CONFIDENTIAL TREATMENT REQUESTED].
If cross reactive with [CONFIDENTIAL TREATMENT REQUESTED] the
antibodies will be tested in [CONFIDENTIAL TREATMENT REQUESTED]
2. Preparation of [CONFIDENTIAL TREATMENT REQUESTED]
Prior to the preparation of the [CONFIDENTIAL TREATMENT REQUESTED],
[CONFIDENTIAL TREATMENT REQUESTED] will be [CONFIDENTIAL TREATMENT REQUESTED]
for [CONFIDENTIAL TREATMENT REQUESTED]. [CONFIDENTIAL TREATMENT REQUESTED] will
be determined. [CONFIDENTIAL TREATMENT REQUESTED] should [CONFIDENTIAL TREATMENT
REQUESTED] certain [CONFIDENTIAL TREATMENT REQUESTED]
2.1 [CONFIDENTIAL TREATMENT REQUESTED]
[CONFIDENTIAL TREATMENT REQUESTED] will be based on [CONFIDENTIAL
TREATMENT REQUESTED] and [CONFIDENTIAL TREATMENT REQUESTED]. All [CONFIDENTIAL
TREATMENT REQUESTED] have been [CONFIDENTIAL TREATMENT REQUESTED] and
[CONFIDENTIAL TREATMENT REQUESTED].
2.2 [CONFIDENTIAL TREATMENT REQUESTED] of [CONFIDENTIAL TREATMENT
REQUESTED]
[CONFIDENTIAL TREATMENT REQUESTED] will be based on [CONFIDENTIAL
TREATMENT REQUESTED] and [CONFIDENTIAL TREATMENT REQUESTED]. All [CONFIDENTIAL
TREATMENT REQUESTED] have been [CONFIDENTIAL TREATMENT REQUESTED] and
[CONFIDENTIAL TREATMENT REQUESTED].
2.3 Characterization of [CONFIDENTIAL TREATMENT REQUESTED] and
[CONFIDENTIAL TREATMENT REQUESTED]
[CONFIDENTIAL TREATMENT REQUESTED] will be conducted on [CONFIDENTIAL
TREATMENT REQUESTED] from [CONFIDENTIAL TREATMENT REQUESTED] to [CONFIDENTIAL
TREATMENT REQUESTED]. [CONFIDENTIAL TREATMENT REQUESTED] will be [CONFIDENTIAL
TREATMENT REQUESTED] for [CONFIDENTIAL TREATMENT REQUESTED] will be conducted to
ensure the [CONFIDENTIAL TREATMENT REQUESTED].
3. [CONFIDENTIAL TREATMENT REQUESTED] Studies
iv
37
CONFIDENTIAL TREATMENT REQUESTED
3.1 Effects of [CONFIDENTIAL TREATMENT REQUESTED] in a [CONFIDENTIAL
TREATMENT REQUESTED] model
We have evidence that [CONFIDENTIAL TREATMENT REQUESTED].
Potential lead [CONFIDENTIAL TREATMENT REQUESTED], therefore, will be
tested for the ability to [CONFIDENTIAL TREATMENT REQUESTED]. The antibodies
will also be tested for [CONFIDENTIAL TREATMENT REQUESTED] with [CONFIDENTIAL
TREATMENT REQUESTED].
If [CONFIDENTIAL TREATMENT REQUESTED] is observed, IDEC will
[CONFIDENTIAL TREATMENT REQUESTED] for their effect on [CONFIDENTIAL TREATMENT
REQUESTED] in the [CONFIDENTIAL TREATMENT REQUESTED] and also by using the
following [CONFIDENTIAL TREATMENT REQUESTED]:
3.2 [CONFIDENTIAL TREATMENT REQUESTED]
We found that [CONFIDENTIAL TREATMENT REQUESTED] can [CONFIDENTIAL
TREATMENT REQUESTED] in [CONFIDENTIAL TREATMENT REQUESTED] up until the
[CONFIDENTIAL TREATMENT REQUESTED] of [CONFIDENTIAL TREATMENT REQUESTED]. The
onset of [CONFIDENTIAL TREATMENT REQUESTED], as measured by [CONFIDENTIAL
TREATMENT REQUESTED] and other parameters, [CONFIDENTIAL TREATMENT REQUESTED].
[CONFIDENTIAL TREATMENT REQUESTED].
Potential [CONFIDENTIAL TREATMENT REQUESTED] will be [CONFIDENTIAL
TREATMENT REQUESTED] for the ability to [CONFIDENTIAL TREATMENT REQUESTED] with
or without [CONFIDENTIAL TREATMENT REQUESTED].
3.3 [CONFIDENTIAL TREATMENT REQUESTED]in susceptible [CONFIDENTIAL
TREATMENT REQUESTED]
[CONFIDENTIAL TREATMENT REQUESTED] has reported that [CONFIDENTIAL
TREATMENT REQUESTED] can [CONFIDENTIAL TREATMENT REQUESTED] of [CONFIDENTIAL
TREATMENT REQUESTED]. The [CONFIDENTIAL TREATMENT REQUESTED] should establish
[CONFIDENTIAL TREATMENT REQUESTED] with [CONFIDENTIAL TREATMENT REQUESTED] in
order to [CONFIDENTIAL TREATMENT REQUESTED] the [CONFIDENTIAL TREATMENT
REQUESTED] of our [CONFIDENTIAL TREATMENT REQUESTED].
4. [CONFIDENTIAL TREATMENT REQUESTED] studies [CONFIDENTIAL TREATMENT
REQUESTED] humanized [CONFIDENTIAL TREATMENT REQUESTED]
A [CONFIDENTIAL TREATMENT REQUESTED] will be conducted using a
[CONFIDENTIAL TREATMENT REQUESTED] that [CONFIDENTIAL TREATMENT REQUESTED]
similar to that observed in [CONFIDENTIAL TREATMENT REQUESTED].
Humanized [CONFIDENTIAL TREATMENT REQUESTED] will be [CONFIDENTIAL
TREATMENT REQUESTED] to be determined as acceptable from
v
38
CONFIDENTIAL TREATMENT REQUESTED
[CONFIDENTIAL TREATMENT REQUESTED] for [CONFIDENTIAL TREATMENT REQUESTED] of the
[CONFIDENTIAL TREATMENT REQUESTED].
5. [CONFIDENTIAL TREATMENT REQUESTED]
5.1 [CONFIDENTIAL TREATMENT REQUESTED] of a [CONFIDENTIAL TREATMENT
REQUESTED] and [CONFIDENTIAL TREATMENT REQUESTED] for transfer [CONFIDENTIAL
TREATMENT REQUESTED]
IDEC will [CONFIDENTIAL TREATMENT REQUESTED] using [CONFIDENTIAL
TREATMENT REQUESTED] and IDEC proprietary technology, in order to [CONFIDENTIAL
TREATMENT REQUESTED] and [CONFIDENTIAL TREATMENT REQUESTED].
6. [CONFIDENTIAL TREATMENT REQUESTED]
6.1 Preliminary [CONFIDENTIAL TREATMENT REQUESTED]
[CONFIDENTIAL TREATMENT REQUESTED] to [CONFIDENTIAL TREATMENT
REQUESTED] of the [CONFIDENTIAL TREATMENT REQUESTED] in various [CONFIDENTIAL
TREATMENT REQUESTED] will be [CONFIDENTIAL TREATMENT REQUESTED] at [CONFIDENTIAL
TREATMENT REQUESTED]. [CONFIDENTIAL TREATMENT REQUESTED] will be conducted
[CONFIDENTIAL TREATMENT REQUESTED] the [CONFIDENTIAL TREATMENT REQUESTED] of
[CONFIDENTIAL TREATMENT REQUESTED] to the [CONFIDENTIAL TREATMENT REQUESTED] of
the [CONFIDENTIAL TREATMENT REQUESTED] in [CONFIDENTIAL TREATMENT REQUESTED].
[CONFIDENTIAL TREATMENT REQUESTED] for the effect of these [CONFIDENTIAL
TREATMENT REQUESTED] on the [CONFIDENTIAL TREATMENT REQUESTED] of the
[CONFIDENTIAL TREATMENT REQUESTED]. [CONFIDENTIAL TREATMENT REQUESTED]
indicating [CONFIDENTIAL TREATMENT REQUESTED] will be [CONFIDENTIAL TREATMENT
REQUESTED] and the results [CONFIDENTIAL TREATMENT REQUESTED].
6.2 Determination of a [CONFIDENTIAL TREATMENT REQUESTED] for use in
[CONFIDENTIAL TREATMENT REQUESTED]
[CONFIDENTIAL TREATMENT REQUESTED] will be conducted to evaluate the
[CONFIDENTIAL TREATMENT REQUESTED] of the antibody. The [CONFIDENTIAL TREATMENT
REQUESTED] that will be evaluated include the [CONFIDENTIAL TREATMENT REQUESTED]
on the chemical and physical properties and [CONFIDENTIAL TREATMENT REQUESTED]
of the antibody. [CONFIDENTIAL TREATMENT REQUESTED] will be explored.
[CONFIDENTIAL TREATMENT REQUESTED] will be examined to [CONFIDENTIAL TREATMENT
REQUESTED] the antibody in [CONFIDENTIAL TREATMENT REQUESTED]. [CONFIDENTIAL
TREATMENT REQUESTED] will be based on [CONFIDENTIAL TREATMENT REQUESTED].
6.3 Standard [CONFIDENTIAL TREATMENT REQUESTED]
The [CONFIDENTIAL TREATMENT REQUESTED] will be [CONFIDENTIAL TREATMENT
REQUESTED] in [CONFIDENTIAL TREATMENT REQUESTED]. The standard [CONFIDENTIAL
TREATMENT REQUESTED] will be fully [CONFIDENTIAL TREATMENT REQUESTED] by the
following parameters:
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CONFIDENTIAL TREATMENT REQUESTED
[CONFIDENTIAL TREATMENT REQUESTED]
7. [CONFIDENTIAL TREATMENT REQUESTED]
Based on [CONFIDENTIAL TREATMENT REQUESTED] factors, several
[CONFIDENTIAL TREATMENT REQUESTED] are being considered. Some [CONFIDENTIAL
TREATMENT REQUESTED] may offer [CONFIDENTIAL TREATMENT REQUESTED] and require
[CONFIDENTIAL TREATMENT REQUESTED], but have [CONFIDENTIAL TREATMENT REQUESTED].
[CONFIDENTIAL TREATMENT REQUESTED] under consideration [CONFIDENTIAL TREATMENT
REQUESTED], but are not [CONFIDENTIAL TREATMENT REQUESTED] to:
[CONFIDENTIAL TREATMENT REQUESTED]
8. [CONFIDENTIAL TREATMENT REQUESTED] Allowance
To submit [CONFIDENTIAL TREATMENT REQUESTED] and initiate
[CONFIDENTIAL TREATMENT REQUESTED] after [CONFIDENTIAL TREATMENT REQUESTED]
allowance (a minimum of [CONFIDENTIAL TREATMENT REQUESTED].
9. Clinical Studies
Below are typical [CONFIDENTIAL TREATMENT REQUESTED] IDEC has
[CONFIDENTIAL TREATMENT REQUESTED] with [CONFIDENTIAL TREATMENT REQUESTED].
9.1 [CONFIDENTIAL TREATMENT REQUESTED]
a) To define a [CONFIDENTIAL TREATMENT REQUESTED] for [CONFIDENTIAL
TREATMENT REQUESTED] when given to patients
b) To characterize [CONFIDENTIAL TREATMENT REQUESTED]
c) To measure [CONFIDENTIAL TREATMENT REQUESTED]
9.2 [CONFIDENTIAL TREATMENT REQUESTED]
o [CONFIDENTIAL TREATMENT REQUESTED] levels will be examined
o [CONFIDENTIAL TREATMENT REQUESTED] to be determined
o [CONFIDENTIAL TREATMENT REQUESTED]
o [CONFIDENTIAL TREATMENT REQUESTED]
vii
40
CONFIDENTIAL TREATMENT REQUESTED
[CONFIDENTIAL TREATMENT REQUESTED] as appropriate
o [CONFIDENTIAL TREATMENT REQUESTED] allowance. Accession to be
completed within [CONFIDENTIAL TREATMENT REQUESTED]
9.3 [CONFIDENTIAL TREATMENT REQUESTED]
o [CONFIDENTIAL TREATMENT REQUESTED] levels will be examined
o [CONFIDENTIAL TREATMENT REQUESTED] - determined according to
[CONFIDENTIAL TREATMENT REQUESTED]
o [CONFIDENTIAL TREATMENT REQUESTED]
o [CONFIDENTIAL TREATMENT REQUESTED][CONFIDENTIAL TREATMENT REQUESTED]
will start as soon as [CONFIDENTIAL TREATMENT REQUESTED] have been
established in the [CONFIDENTIAL TREATMENT REQUESTED]. [CONFIDENTIAL
TREATMENT REQUESTED] to be completed within [CONFIDENTIAL TREATMENT
REQUESTED]. Total length of [CONFIDENTIAL TREATMENT REQUESTED] for
[CONFIDENTIAL TREATMENT REQUESTED] will probably be [CONFIDENTIAL
TREATMENT REQUESTED], depending on [CONFIDENTIAL TREATMENT REQUESTED]
time prior to [CONFIDENTIAL TREATMENT REQUESTED], etc.
10. [CONFIDENTIAL TREATMENT REQUESTED] Clinical Studies
o [CONFIDENTIAL TREATMENT REQUESTED] of finished product
o [CONFIDENTIAL TREATMENT REQUESTED] to be defined by the parties
viii
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CONFIDENTIAL TREATMENT REQUESTED
COLLABORATIVE DEVELOPMENT AGREEMENT
APPENDIX D - MANUFACTURING PROCESS
(a) APPENDIX D - MANUFACTURING PROCESS
1. Manufacturing
o A supply of vials from the [CONFIDENTIAL TREATMENT REQUESTED]
sufficient for ongoing manufacturing purposes
o Written descriptions for [CONFIDENTIAL TREATMENT REQUESTED].
o Written descriptions for [CONFIDENTIAL TREATMENT REQUESTED].
o Written descriptions for [CONFIDENTIAL TREATMENT REQUESTED].
o Written descriptions for [CONFIDENTIAL TREATMENT REQUESTED].
o Written descriptions for [CONFIDENTIAL TREATMENT REQUESTED].
o Media and buffer descriptions for [CONFIDENTIAL TREATMENT REQUESTED].
o Recommended manufacturers of [CONFIDENTIAL TREATMENT REQUESTED],
including [CONFIDENTIAL TREATMENT REQUESTED].
o Summary of historical performance for each step of the process,
including [CONFIDENTIAL TREATMENT REQUESTED].
The intent of the MANUFACTURING PROCESS is to [CONFIDENTIAL TREATMENT
REQUESTED] of the manufacturing process to [CONFIDENTIAL TREATMENT REQUESTED]
using [CONFIDENTIAL TREATMENT REQUESTED] and an [CONFIDENTIAL TREATMENT
REQUESTED] suitable for [CONFIDENTIAL TREATMENT REQUESTED].
2. Product Testing
[CONFIDENTIAL TREATMENT REQUESTED] will be tested for the
[CONFIDENTIAL TREATMENT REQUESTED]. [CONFIDENTIAL TREATMENT REQUESTED] will be
characterized [CONFIDENTIAL TREATMENT REQUESTED]. [CONFIDENTIAL TREATMENT
REQUESTED] will again be characterized [CONFIDENTIAL TREATMENT REQUESTED]. These
assays and procedure have already been established and validated at
[CONFIDENTIAL TREATMENT REQUESTED] in support of the development of several
other [CONFIDENTIAL TREATMENT REQUESTED].
2.1 [CONFIDENTIAL TREATMENT REQUESTED]
[CONFIDENTIAL TREATMENT REQUESTED] will be based on [CONFIDENTIAL
TREATMENT REQUESTED] and, if required, on [CONFIDENTIAL TREATMENT REQUESTED].
2.2 [CONFIDENTIAL TREATMENT REQUESTED]
ix
42
CONFIDENTIAL TREATMENT REQUESTED
[CONFIDENTIAL TREATMENT REQUESTED] will be based on [CONFIDENTIAL
TREATMENT REQUESTED], and, if required, on [CONFIDENTIAL TREATMENT REQUESTED].
2.3 [CONFIDENTIAL TREATMENT REQUESTED]
[CONFIDENTIAL TREATMENT REQUESTED] will be based on [CONFIDENTIAL
TREATMENT REQUESTED], and, if required, on [CONFIDENTIAL TREATMENT REQUESTED].
x
43
CONFIDENTIAL TREATMENT
COLLABORATIVE DEVELOPMENT AGREEMENT
APPENDIX E - PRODUCT DEVELOPMENT PLAN FOR TAISHO TERRITORY
xi
