Collaborative Development Agreement - Mitsubishi-Tokyo Pharmaceuticals Inc. and IDEC Pharmaceuticals Corp.
This COLLABORATIVE DEVELOPMENT AGREEMENT ("CDA"), is made effective this
21st day of September, 2001 ("EFFECTIVE DATE"), between Mitsubishi-Tokyo
Pharmaceuticals, Inc., a company organized under Japanese law and having its
principal executive offices at 2-6, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo
103-8405, Japan ("MTP") and IDEC Pharmaceuticals Corporation, a corporation
organized under the laws of the State of Delaware and having its principal
executive offices at 3030 Callan Road, San Diego, California 92121, USA
("IDEC").
BACKGROUND
WHEREAS, IDEC is engaged in research and development and has accumulated
considerable knowledge relating to antibody-based products directed against the
B7 cell function, and the use of such products for the palliation, evaluation,
diagnosis, treatment and/or prophylaxis of human disease states which are caused
or exacerbated by cells expressing the B7 (CD80) antigen;
WHEREAS, MTP is interested in performing clinical development relating to
such antibody products;
WHEREAS, Mitsubishi Kasei Corporation (a predecessor in interest to MTP)
and IDEC are parties to that certain License Agreement of November 11, 1993
("LICENSE AGREEMENT"), under which the Parties have granted the licenses set
forth under Section 2.04 (i)-(iv) of the LICENSE AGREEMENT, as further specified
therein;
WHEREAS, Mitsubishi Kasei Corporation and IDEC where previously parties
to a certain Collaborative Development Agreement dated as of November 11, 1993
("CDA1"), as amended by that certain Memorandum of Understanding between the
parties dated December 11, 1996 ("MOU"), and that certain letter agreement of
December 13, 1996 ("LETTER AGREEMENT") (collectively "the ORIGINAL CDA
AGREEMENTS");
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WHEREAS, IDEC has developed an anti-CD80 antibody (IDEC-114) and has
completed a Phase I/II clinical trial and has an ongoing Phase II clinical
trial, each studying the use of IDEC-114 in the treatment of psoriasis;
WHEREAS, [CONFIDENTIAL TREATMENT REQUESTED]; and
WHEREAS, both MTP and IDEC desire to renew their collaboration in the
further development of IDEC-114 for the treatment of psoriasis.
NOW, THEREFORE, in consideration of the covenants and obligations
expressed herein, and intending to be legally bound, and otherwise to be bound
by proper and reasonable conduct, the PARTIES agree as follows:
ARTICLE I. DEFINITIONS
1.01 "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 lesser percentage which is the
maximum allowed to be owned by a foreign corporation in a particular
jurisdiction) having the power to vote on 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.
1.02 "BLA" shall mean a Biologics License Application as contemplated by Title
42 U.S.C.S. Section 262, et seq. of the Public Health Service Act (PHSA) as
amended from time to time, filed by IDEC directed to use of the PRODUCT in the
FIELD.
1.03 "BEST EFFORTS" shall mean the maximum effort consistent with the
reasonable and prudent exercise of business judgment for a commercial
enterprise.
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1.04 "IDEC CDA DEVELOPMENT" shall mean the clinical development program and
any non-clinical investigation (other than manufacturing studies) on a PRODUCT
within the FIELD conducted during the term of this CDA or any extensions thereof
under Section 6.01, with the intent and purpose of generating data for
submission to a regulatory authority in the IDEC TERRITORY in support of an
application for governmental approval required for commercializing PRODUCT
within the FIELD. Such development plan shall be carried out in accordance with
ARTICLE 3, APPENDIX A and any non-clinical investigation deemed necessary by
IDEC to support IDEC CLINICAL TRIALS.
1.05 "MTP CDA DEVELOPMENT" shall mean the clinical development program on a
PRODUCT conducted during the term of this CDA or any extensions thereof under
Section 6.01, with the intent and purpose of generating data for submission to a
regulatory authority in the MTP TERRITORY in support of an application for
governmental approval required for commercializing PRODUCT within the FIELD.
Such development plan shall be carried out in accordance with ARTICLE 3,
APPENDIX B and any non-clinical investigation deemed necessary by MTP to support
MTP CLINICAL TRIALS.
1.06 "CDA DEVELOPMENT" shall mean IDEC CDA DEVELOPMENT and MTP CDA
DEVELOPMENT.
1.07 "CDA INFORMATION" shall mean any and all proprietary or confidential
data, know-how and results obtained from CDA DEVELOPMENT as further described in
ARTICLE 3 of this CDA, but shall not include any vectors or expression cassettes
discovered or created by either PARTY during the term of this CDA or CDA1.
1.08 "CLINICAL TRIAL" shall mean any PHASE I, PHASE I/II, PHASE II or PHASE
III CLINICAL TRIAL, conducted by either PARTY [CONFIDENTIAL TREATMENT
REQUESTED].
1.09 "FDA" shall mean the United States Food and Drug Administration.
1.10 [CONFIDENTIAL TREATMENT REQUESTED].
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1.11 "FIELD" shall mean use of the PRODUCT for in vivo treatment of psoriasis
in humans and in vitro diagnosis and evaluation of human tissue or fluid
relating to psoriasis.
1.12 [CONFIDENTIAL TREATMENT REQUESTED].
1.13 "IDEC TERRITORY" shall mean the entire world except the MTP TERRITORY.
1.14 "MITSUBISHI TECHNOLOGY" shall mean all MTP technology, know-how and
PATENTs which relates to PRODUCT, that MTP or its AFFILIATES owns or controls
either directly or indirectly, and to which MTP has the right to grant licenses
or sublicenses and developed during the term of this CDA or known to MTP as of
the EFFECTIVE DATE of this CDA, including, but not limited to, its antibody
technology, mammalian host-vector systems for high level expression of proteins,
manufacturing systems for GMP production of clinical grade antibodies, the
appropriate research samples of anti-murine B7 antibody(ies), cell lines
producing such antibodies, and pharmacological technology providing the
scientific basis for the clinical development of the PRODUCT, but shall not
include any vectors or expression cassettes discovered or created by either
PARTY during the term of this CDA.
1.15 "MTP TERRITORY" shall mean Japan, People's Republic of China, Hong Kong,
Republic of Korea, Singapore, Republic of China (Taiwan), Thailand, Indonesia,
Philippines, Malaysia, and all territories and possessions of such countries.
1.16 "PARTY" shall mean IDEC or MTP, as the case may be; "PARTIES" shall mean
IDEC and MTP.
1.17 "PATENTS" shall have the definition set forth in the LICENSE AGREEMENT.
1.18 "PHASE I CLINICAL TRIAL" shall mean a human clinical trial that is
intended to initially evaluate the safety and/or pharmacological effect of
PRODUCT in the FIELD in
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subjects or that would otherwise satisfy requirements of 21 CFR 312.21(a), or
its foreign equivalent. [CONFIDENTIAL TREATMENT REQUESTED].
1.19 "PHASE I/II CLINICAL TRIAL" shall mean a human clinical trial that is
intended to evaluate the safety and effectiveness of PRODUCT in the FIELD in
subjects or that would otherwise satisfy requirements of 21 CFR 312.21(a/b), or
its foreign equivalent. [CONFIDENTIAL TREATMENT REQUESTED].
1.20 "PHASE II CLINICAL TRIAL" shall mean a human clinical trial that is
intended to initially evaluate the effectiveness of PRODUCT in the FIELD in
subjects or that would otherwise satisfy requirements of 21 CFR 312.21(b), or
its foreign equivalent [CONFIDENTIAL TREATMENT REQUESTED].
1.21 "PHASE III CLINICAL TRIAL" shall mean a pivotal human clinical trial, the
results of which could be used to establish safety and efficacy of PRODUCT in
the FIELD as a basis for a BLA or that would otherwise satisfy requirements of
21 CFR 312.21(c), or its foreign equivalent [CONFIDENTIAL TREATMENT REQUESTED].
1.22 "PRODUCT" shall mean that certain antibody developed and owned by IDEC
that binds the human B7 (CD80) and is denominated IDEC-114.
1.23 "REAGENTS" shall mean cell lines expressing PRODUCT, including, but not
limited to transfected CHO cell lines expressing PRODUCT, and other compositions
of matter, such as, but not limited to those necessary or useful to develop or
produce PRODUCT, but shall expressly not include primers, Ig libraries, phages,
phagemids, plasmids, expression vectors or expression cassettes.
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1.24 "THIRD PARTY(IES)" shall mean any party other than a PARTY to this CDA or
an AFFILIATE of MTP or IDEC.
ARTICLE II. CLINICAL DEVELOPMENT
2.01 Except as otherwise specifically provided herein, IDEC and MTP each shall
conduct any CDA DEVELOPMENT which such party undertakes in a scientific manner
in accordance with high scientific, medical and professional standards, and in
compliance in all material respects with all requirements of applicable laws,
rules and regulations and all applicable standard clinical practices to attempt
to achieve their objectives efficiently and expeditiously. The general terms
regarding the efforts to be undertaken in furtherance of CDA DEVELOPMENT,
including the objectives thereof, have been mutually agreed upon by the PARTIES,
and such agreement is incorporated upon the EFFECTIVE DATE within APPENDIX A of
this CDA and is a part thereof.
2.02 The principal scientists who will direct the respective responsibilities
of each PARTY are, for IDEC: [CONFIDENTIAL TREATMENT REQUESTED], and for MTP:
[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 CDA DEVELOPMENT,
shall be directed to said principal scientists.
2.03 [CONFIDENTIAL TREATMENT REQUESTED]
2.04 MTP and IDEC each certifies that it is regularly engaged in conducting
clinical trials in vivo in humans, and that all biological materials and/or
chemicals provided by one PARTY to the other under this CDA shall be used in
compliance with all applicable laws and regulations.
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2.05 MTP shall have full scientific and management authority and
responsibility for the CDA DEVELOPMENT of PRODUCT within the MTP TERRITORY
including attainment and maintenance of regulatory approvals and price
registrations and shall have the right, from time to time as it sees fit, to
amend the MTP CDA activities set forth in Appendix B. All such activity shall be
undertaken [CONFIDENTIAL TREATMENT REQUESTED]. IDEC shall have full scientific
and management authority and responsibility for any CDA DEVELOPMENT of PRODUCT
in the IDEC TERRITORY and shall have the right, from time to time as it sees
fit, to amend the IDEC CDA activities set forth in Appendix A, subject to MTP's
rights under Section 6.02.
2.06 Except as otherwise specifically provided herein, the foregoing does not
imply a duty on the part of IDEC or MTP to complete or commence any CLINICAL
TRIAL or conduct any CDA DEVELOPMENT activities.
ARTICLE III. FUNDING OF CLINICAL DEVELOPMENT
3.01 In partial consideration for data generated by IDEC and provided to MTP
relating to IDEC's PHASE I/II CLINICAL TRIAL, and for ongoing development of the
PRODUCT, MTP shall make [CONFIDENTIAL TREATMENT REQUESTED].
3.02 MTP shall share in the funding of CDA DEVELOPMENT conducted by IDEC,
including past, ongoing and future CLINICAL TRIALS conducted by or on behalf of
IDEC, by making [CONFIDENTIAL TREATMENT REQUESTED] payments to IDEC as set forth
below.
(a) [CONFIDENTIAL TREATMENT REQUESTED] after receipt of any invoice
requesting payment, MTP shall make payment to IDEC in the amount of
[CONFIDENTIAL TREATMENT REQUESTED].
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(b) Notwithstanding (a) above, [CONFIDENTIAL TREATMENT REQUESTED].
(c) Notwithstanding anything to the contrary herein, the obligation of MTP to
make [CONFIDENTIAL TREATMENT REQUESTED].
3.03 MTP shall make the following [CONFIDENTIAL TREATMENT REQUESTED] MILESTONE
PAYMENTS [CONFIDENTIAL TREATMENT REQUESTED] to IDEC [CONFIDENTIAL TREATMENT
REQUESTED] after written notice is given to MTP that such milestone has been
achieved:
[CONFIDENTIAL TREATMENT REQUESTED].
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[CONFIDENTIAL TREATMENT REQUESTED].
3.04 (a) (a) If applicable laws, rules or regulations require withholding of
income taxes or other taxes imposed upon INITIAL PAYMENTS and/or MILESTONE
PAYMENTS, the PARTIES [CONFIDENTIAL TREATMENT REQUESTED].
(b) [CONFIDENTIAL TREATMENT REQUESTED].
ARTICLE IV. EXCHANGE OF INFORMATION AND CONFIDENTIALITY
4.01 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. Accordingly, each PARTY shall regularly report
to the other on the status and progress of its CLINICAL TRIAL efforts and as
further set forth in Section 4.02. Each PARTY agrees to prepare and exchange all
written reports in the English language. The exchange of such reports
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may be reasonably supplemented, at the request of the PARTY receiving a report,
by correspondence and/or visits to the other PARTY's facility.
4.02 Subject to the terms and conditions of this CDA, information
and data shall further be shared among the PARTIES as described below.
IDEC hereby grants to MTP a non-exclusive license in MTP TERRITORY,
[CONFIDENTIAL TREATMENT REQUESTED], to use such information and data
received from IDEC to research, develop, make, have made, use, import,
export, promote, market, offer for sale, sell and have sold the PRODUCT.
(a) [CONFIDENTIAL TREATMENT REQUESTED]
(b) [CONFIDENTIAL TREATMENT REQUESTED]
(c) [CONFIDENTIAL TREATMENT REQUESTED]
(d) [CONFIDENTIAL TREATMENT REQUESTED]
(e) [CONFIDENTIAL TREATMENT REQUESTED]
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(f) [CONFIDENTIAL TREATMENT REQUESTED]
4.03 During the term of the CDA, if IDEC enters into an agreement with a
THIRD PARTY under which IDEC grants such THIRD PARTY a license to make, have
made, use or sell any PRODUCT in the FIELD in any country in the IDEC
TERRITORY, [CONFIDENTIAL TREATMENT REQUESTED].
4.04 Each PARTY shall promptly report to the other PARTY any confirmed
information of serious or unexpected reactions or side effects related to the
utilization or medical administration of PRODUCT. In this regard, each PARTY
agrees that, throughout the duration of this CDA and thereafter, it will notify
the other PARTY immediately of any information concerning any PRODUCT or package
complaint, or any serious human adverse event, injury, toxicity or sensitivity
reaction or any unexpected incidence or severity thereof associated with the
clinical uses, studies, investigations, tests and marketing of PRODUCT, whether
or not determined to be attributable to PRODUCT. "Serious" as used in this
Section refers to experience which results in death, permanent or substantial
disability, in-patient hospitalization, prolongation of existing in-patient
hospitalization; or is a congenital anomaly or life threatening. "Unexpected" as
used in this Section refers to: (i) conditions or developments encountered
during preclinical or clinical studies which could be material to the successful
continuance of development of PRODUCT; (ii) conditions or developments not
encountered during clinical studies of PRODUCT; and (iii)
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conditions or developments occurring with greater frequency, severity or
specificity than shown by information previously submitted to governmental
agencies or encountered during clinical studies of PRODUCT. Each PARTY shall
also notify the other PARTY in a timely manner of any other adverse experience
(i.e., any unfavorable and unintended change in the structure (signs), function
(symptoms) or chemistry (laboratory data)) of the body temporally associated
with the use of PRODUCT, whether or not considered related thereto. The PARTIES
further agree to negotiate pharmacovigilance reporting requirements.
4.05 Each PARTY shall throughout the duration of this CDA and thereafter
immediately notify the other PARTY of any information it receives regarding any
threatened or pending action by any regulatory agency in any country of the
world which may affect the safety or efficacy claims of PRODUCT or the continued
development or marketing of PRODUCT. Upon receipt of any such information, each
PARTY may consult with the other PARTY in an effort to arrive at a mutually
acceptable procedure for taking appropriate action; provided, however, that
nothing contained herein shall be construed as restricting either PARTY's
ability to make a timely report of such matter to any governmental agency or
take other action that it deems to be appropriate or required by applicable law
or regulation.
4.06 The PARTIES agree throughout the duration of this CDA and for the
duration of marketing, by either PARTY, of any PRODUCT in the FIELD to maintain
records and otherwise establish procedures to assure compliance with all
regulatory, professional or other legal requirements which apply to the
development, promotion and marketing of PRODUCT.
4.07 Neither PARTY shall disclose the existence of or any terms or conditions
of this CDA to any THIRD PARTY, either in a press release or in any other
manner, without the prior written consent of the other PARTY; provided, however,
that (subject to any applicable THIRD PARTY rights, obligations or restrictions)
a PARTY may disclose the terms or conditions of this CDA (a) on a need-to-know
and confidential basis to its professional legal and financial advisors to the
extent such disclosure is reasonably necessary, and (b) to a THIRD PARTY in
connection with (i) an equity investment in a PARTY to this CDA, (ii) a merger,
consolidation or similar transaction by a PARTY to this CDA, or (iii) the sale
of all or substantially all of the assets of a
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PARTY to this CDA, provided that all of the foregoing shall be subject to
confidentiality and non-use obligations imposed by this CDA and the LICENSE
AGREEMENT.
4.08 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 the PARTIES that must be disclosed to the public and the
PARTY's shareholders via a press release. Such a press release shall be prepared
by the other PARTY and reviewed in good faith and approved by the other PARTY
concurrently with the review and approval of this CDA or early termination
thereof.
4.09 Notwithstanding the foregoing, 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 to this CDA, except as may be legally required,
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.
4.10 Neither MTP nor IDEC shall submit for written publication any manuscript
abstract or the like, or make any oral presentation, which includes data or
other information generated or provided by the other PARTY in the course of, or
otherwise as a result of, CDA 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.
4.11 Neither MTP nor IDEC may, during the term of this CDA [CONFIDENTIAL
TREATMENT REQUESTED], disclose or reveal to THIRD PARTIES any CDA INFORMATION
received from the other PARTY or otherwise developed by either PARTY in the
performance of activities in furtherance of this
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CDA, except that such other PARTY may use or disclose such confidential
information (i) for the purposes of investigating, developing, manufacturing,
marketing or seeking partners for PRODUCT, provided that prior to any such
disclosure such potential partners are bound to at least as stringent
confidentiality obligations as set forth herein, (ii) for securing essential or
desirable authorizations, privileges or rights from governmental agencies, (iii)
if required to be disclosed to a governmental agency, or (iv) 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 or
the LICENSE AGREEMENT (unless otherwise disclosed confidentially at any time by
MTP to IDEC or IDEC to MTP), 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 CDA INFORMATION 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 CDA INFORMATION is granted.
4.12 Subject to the terms of the LICENSE AGREEMENT, 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 V. PRODUCT SUPPLY
5.01 IDEC shall use its BEST EFFORTS to manufacture and supply to MTP,
[CONFIDENTIAL TREATMENT REQUESTED], PRODUCT manufactured under Good
Manufacturing Practice guidelines solely for the purpose of conducting CLINICAL
TRIALS in the MTP TERRITORY, as follows: [CONFIDENTIAL TREATMENT REQUESTED].
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If MTP desires vialed PRODUCT for conducting PHASE II CLINICAL TRIALS, MTP must
provide a firm order [CONFIDENTIAL TREATMENT REQUESTED] prior to delivery of
such vialed PRODUCT by IDEC to MTP. In any event, the amount of product
requested by MTP must be reasonably related to requirements for conducting such
studies under the appropriate protocols. IDEC shall establish cell lines,
manufacture and set specifications in accordance with applicable FDA and KOROSHO
(the Japanese Ministry of Health, Labor and Welfare) guidelines; however, if
additional development expense is required to meet KOROSHO`s guidelines,
[CONFIDENTIAL TREATMENT REQUESTED]. The obligations of IDEC under this Section
shall be suspended upon provision by IDEC to MTP of notice to terminate under
Section 6.04. The details of PRODUCT supply defined above, including
formulations of the PRODUCT like formulated bulk form or vialed Product, shall
be determined in any SUPPLY AGREEMENT between the PARTIES separately.
5.02 [CONFIDENTIAL TREATMENT REQUESTED]
ARTICLE VI. TERM AND TERMINATION
6.01 This CDA shall come into effect on the EFFECTIVE DATE and, unless earlier
terminated hereunder, shall continue to be in effect [CONFIDENTIAL TREATMENT
REQUESTED]. If continued research or development is desirable, the collaboration
may be extended by mutual agreement between the PARTIES on reasonable terms and
conditions to be negotiated in good faith.
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6.02 MTP shall have the right to terminate this CDA [CONFIDENTIAL TREATMENT
REQUESTED].
6.03 IDEC shall have the right to terminate this CDA [CONFIDENTIAL TREATMENT
REQUESTED]. In such case, IDEC shall provide MTP with all data obtained by IDEC
prior to the termination and all reports written based on such data.
6.04 Either PARTY shall have the right to terminate this CDA if the other
PARTY materially fails or neglects to perform its obligation set forth in this
CDA and if such default is not cured [CONFIDENTIAL TREATMENT REQUESTED] after
receiving written request to cure such default from the other PARTY, such other
PARTY shall have the right to terminate this CDA by giving written notice to the
PARTY in default, provided the request to cure is given [CONFIDENTIAL TREATMENT
REQUESTED].
6.05 If not earlier terminated, this CDA shall automatically terminate upon
termination of the LICENSE AGREEMENT.
ARTICLE VII. RIGHTS AND DUTIES UPON TERMINATION
7.01 Upon expiration or termination of this CDA by either PARTY under any
section of ARTICLE 6 hereof, unless otherwise expressly provided herein,
(a) [CONFIDENTIAL TREATMENT REQUESTED]
(b) [CONFIDENTIAL TREATMENT REQUESTED]
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(c) [CONFIDENTIAL TREATMENT REQUESTED]
(d) all other obligations and provisions of this CDA shall terminate except
(i) the following which shall survive such termination: Sections 2.04,
4.04, 4.05, 4.06, 4.07, 4.08, 4.10, 4.11, 5.02 and Articles 7, 8,
10 through 16; and
(ii) in the case of expiration of this CDA, termination of this CDA
under Section 6.02 or 6.03 or termination of this CDA by MTP under
Section 6.04, the following which shall survive such expiration or
termination: the license grant only of Section 4.02, but NOT IDEC's
obligations to provide data or information which MTP does not have
the right to receive at the time of such expiration or termination
(e.g., BLA dossier).
7.02 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.
ARTICLE VIII. WARRANTIES, REPRESENTATIONS,
INSURANCE AND INDEMNIFICATIONS
8.01 NOTHING IN THIS CDA SHALL BE CONSTRUED AS A WARRANTY THAT PATENTS ARE
VALID OR ENFORCEABLE OR THAT THEIR EXERCISE DOES NOT INFRINGE ANY VALID PATENT
RIGHTS OF THIRD PARTIES. A holding of invalidity or unenforceability of any
PATENT, from which no further appeal is or can be taken, shall not affect any
obligation already accrued hereunder.
8.02 MTP shall defend, indemnify and hold harmless IDEC, its officers,
directors, shareholders, employees, successors and assigns from (i) any and all
losses, damages, liabilities and expenses, 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 death, brought by or on
behalf of an injured party, and (ii) 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 MTP (or any sublicensee of MTP), except to the
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extent such damages, claims, costs, losses, liabilities or expenses are caused
solely by IDEC's gross negligence or willful misconduct of any employee or agent
of IDEC and provided:
(a) MTP shall have no obligation under this Section, unless (i) IDEC gives
MTP prompt written notice of any claim or lawsuit or other action for
which it seeks to be indemnified under this CDA, and (ii) MTP is granted
full authority and control over the defense, including settlement,
against such claim or lawsuit or other action, provided, however, that
MTP may not enter into any settlement or other agreement that would
materially limit the scope of any claim of IDEC's PATENTS, as defined in
the LICENSE AGREEMENT without the prior written consent of IDEC, which
consent shall not be unreasonably withheld or delayed; and
(b) IDEC 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, except as
provided in subsection (a) above, that MTP shall have final authority 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.
8.03 IDEC shall defend, indemnify and hold harmless MTP, its officers,
directors, shareholders, employees, successors and assigns from (i) any and all
losses, damages, liabilities and expenses, 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 death, brought by or on
behalf of an injured party, and (ii) 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 IDEC (or any licensee of IDEC other than MTP), except to the extent such
damages, claims, costs, losses, liabilities or expenses are caused solely by
MTP's gross negligence or willful misconduct of any employee or agent of MTP and
provided:
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(a) IDEC shall have no obligation under this Section, unless (i) MTP gives
IDEC prompt written notice of any claim or lawsuit or other action for
which it seeks to be indemnified under this CDA, and (ii) IDEC is granted
full authority and control over the defense, including settlement,
against such claim or lawsuit or other action, provided, however, that
IDEC may not enter into any settlement or other agreement that would
materially limit the scope of any claim of MTP's PATENTS, as defined in
the LICENSE AGREEMENT without the prior written consent of MTP, which
consent shall not be unreasonably withheld or delayed; and
(b) MTP 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, except as
provided in subsection (a) above, that IDEC shall have final authority to
handle any such claim, complaint, suit, proceeding or cause of action,
including any settlement or other disposition thereof, for which MTP
seeks indemnification under this Section.
8.04 IDEC shall defend, indemnify and hold harmless MTP 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 activities under this CDA, including, but not limited to, IDEC's
activities related to CDA DEVELOPMENT, IDEC's transfer of CDA INFORMATION to
MTP, any breach of a representation or warranty made to MTP by IDEC under this
CDA, except such damages, claims, costs, losses, liabilities or expenses which
are directly and proximately caused by MTP's gross negligence, provided MTP
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, provided, however, that IDEC 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 MTP seeks indemnification under this Section.
8.05 MTP 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
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resulting from or in connection with MTP's activities under this CDA, including,
but not limited, to MTP's activities related to CDA DEVELOPMENT, or any breach
of a representation or warranty made to MTP by IDEC under this CDA, except such
damages, claims, costs, losses, liabilities or expenses which are directly and
proximately caused solely by IDEC's gross negligence, provided 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, provided, however, that MTP 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.
8.06 Except for a breach of Section 4.11 of this CDA, 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 IX. FORCE MAJEURE
9.01 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, 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.
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CONFIDENTIAL TREATMENT REQUESTED
ARTICLE X. GOVERNING LAW
10.01 This CDA shall be deemed to have been made in the State of California,
U.S.A. and its form, execution, validity, construction and effect shall be
determined in accordance with the laws of the State of California, U.S.A. as it
is applied to contracts entered into in the State of California between
California residents.
ARTICLE XI. ARBITRATION
11.01 Any dispute, controversy or claim (except as to any issue relating to
intellectual property owned in whole or in part by IDEC) arising out of or
relating to this CDA, or the breach, termination, or invalidity thereof, shall
be settled by arbitration in accordance with the Commercial Arbitration Rules of
the American Arbitration Association, except as modified by this Section 11.01.
The number of arbitrators shall be [CONFIDENTIAL TREATMENT REQUESTED]. 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, CA, unless the PARTIES agree in writing to
conduct the arbitration in another location.
11.02 Notwithstanding anything contained in Section 11.01 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 PARTIES rights hereunder through reformation of
contract, specific performance, injunction, or similar equitable relief.
ARTICLE XII. SEVARABILITY
12.01 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.
12.02 If any of the terms or provisions of this CDA are in conflict with any
applicable United States or California 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.
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CONFIDENTIAL TREATMENT
12.03 In the event that the terms and conditions of this CDA are materially
altered as a result of Sections 12.01 or 12.02, the PARTIES will renegotiate the
terms and conditions of this CDA to resolve any inequities.
ENTIRE AGREEMENT
12.04 This CDA, together with the LICENSE AGREEMENT, constitutes the entire
agreement between the PARTIES relating to the subject matter hereof, and
supersedes all previous writings and understandings in the ORIGINAL CDA
AGREEMENTS. 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 XIII. PRIMACY
13.01 To the extent that any provision of this CDA conflicts with any
provision of any other agreement between the parties, the terms of this CDA
shall control.
ARTICLE XIV. NOTICES
14.01 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
3030 Callan Road
San Diego, California 92121 U.S.A.
Attention: Corporate Secretary
Copy to: President
MITSUBISHI-TOKYO PHARMACEUTICALS, INC.
2-6, Nihonbashi-Honcho 2-chome
Chuo-ku, Tokyo 103-84050 Japan
Attention: General Manager, Licensing Department
Copy to: General Manager of Preclinical Development Department; and General
Manager of Intellectual Property Department
14.02 Any notice required or permitted to be given concerning this CDA shall
be effective upon receipt by the PARTY to whom it is addressed.
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CONFIDENTIAL TREATMENT
ARTICLE XV. ASSIGNMENT
15.01 This CDA and the licenses 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; provided, however, that IDEC 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 the consent of
the other PARTY.
ARTICLE XVI. RECORDATION
16.01 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.
EXECUTION IN COUNTERPARTS
16.02 This CDA may be executed in any number of counterparts, each of which
shall be deemed an original, but all of which together shall constitute one and
the same instrument.
(a) IN WITNESS WHEREOF, the PARTIES, through their authorized officers, have
executed this CDA.
MITSUBISHI-TOKYO PHARMACEUTICALS, INC.
By: /s/ Ryuichi Tomizawa
--------------------------
Name: Ryuichi Tomizawa
Title: President
Date:
------------------------
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CONFIDENTIAL TREATMENT
ATTESTED:
By: /s/ Akihiro Tobe
--------------------------
Name: Akihiro Tobe
Title: President of Research and Development Division
Date:
------------------------
IDEC PHARMACEUTICALS CORPORATION
By: /s/ William R. Rohn
--------------------------
William R. Rohn
Title: Chief Operating Officer
------------------------
Date:
------------------------
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CONFIDENTIAL TREATMENT REQUESTED
COLLABORATIVE DEVELOPMENT AGREEMENT
MITSUBISHI-TOKYO PHARMACEUTICALS, INC.-IDEC
PHARMACEUTICALS CORPORATION
APPENDIX A--CLINICAL PLAN FOR IDEC CDA DEVELOPMENT
[CONFIDENTIAL TREATMENT REQUESTED]
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CONFIDENTIAL TREATMENT REQUESTED
COLLABORATIVE DEVELOPMENT AGREEMENT
MITSUBISHI-TOKYO PHARMACEUTICALS, INC.-IDEC
PHARMACEUTICALS CORPORATION
APPENDIX B--CLINICAL PLAN FOR MTP CDA DEVELOPMENT
[CONFIDENTIAL TREATMENT REQUESTED]
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