License Agreement - Taisho Pharmaceutical Co. Ltd. and IDEC Pharmaceuticals Corp.
LICENSE AGREEMENT
TAISHO PHARMACEUTICAL CO., LTD. - IDEC PHARMACEUTICALS
CORPORATION
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CONFIDENTIAL TREATMENT
LICENSE AGREEMENT
TAISHO PHARMACEUTICAL CO., LTD. - IDEC PHARMACEUTICALS CORPORATION
TABLE OF CONTENTS
PAGE
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TABLE OF CONTENTS........................................................... i
ARTICLE 1 DEFINITIONS....................................................... 2
ARTICLE 2 GRANTS............................................................ 6
ARTICLE 3 PAYMENTS.......................................................... 8
ARTICLE 4 DEVELOPMENT AND COMMERCIALIZATION IN TAISHO TERRITORY............. 10
ARTICLE 5 TERM AND TERMINATION.............................................. 11
ARTICLE 6 RIGHTS AND DUTIES UPON TERMINATION................................ 13
ARTICLE 7 EXCHANGE OF INFORMATION AND CONFIDENTIALITY....................... 14
ARTICLE 8 INVENTIONS, PATENTS AND PATENT PROSECUTION........................ 17
ARTICLE 9 PATENT LITIGATION................................................. 20
ARTICLE 10 PRODUCT SUPPLY................................................... 22
ARTICLE 11 TRADEMARKS AND TRADENAMES........................................ 24
ARTICLE 12 STATEMENTS AND REMITTANCES....................................... 24
ARTICLE 13 WARRANTIES, REPRESENTATIONS, INSURANCE AND INDEMNIFICATIONS...... 26
ARTICLE 14 FORCE MAJEURE.................................................... 29
ARTICLE 15 GOVERNING LAW.................................................... 29
ARTICLE 16 DISPUTE RESOLUTION............................................... 29
ARTICLE 17 SEPARABILITY..................................................... 30
ARTICLE 18 ENTIRE AGREEMENT................................................. 31
ARTICLE 19 NOTICES.......................................................... 31
ARTICLE 20 ASSIGNMENT....................................................... 32
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CONFIDENTIAL TREATMENT
ARTICLE 21 RECORDATION...................................................... 32
ARTICLE 22 EXECUTION IN COUNTERPARTS........................................ 32
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APPENDIX TABLE
APPENDIX A: PATENTS AND PATENT APPLICATIONS................................ i
APPENDIX B: MANUFACTURING PROCESS.......................................... ii
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CONFIDENTIAL TREATMENT
LICENSE AGREEMENT
This LICENSE AGREEMENT, effective this 22nd day of December, l999
("EFFECTIVE DATE"), between Taisho Pharmaceutical Co., Ltd., a corporation
organized under Japanese law and having its principal executive offices at 24-1,
Takata 3-chome, Toshima-ku, Tokyo, 170-8633, Japan ("TAISHO") and IDEC
Pharmaceuticals Corporation, a company organized under the laws of the State of
Delaware and having its principal executive offices at 11011 Torreyana Road, San
Diego, California 92121, USA ("IDEC").
BACKGROUND
WHEREAS, IDEC is the owner of all right, title and interest in, or
otherwise has the right to grant certain licenses in, certain patents and patent
applications identified in APPENDIX A hereto, and know-how relating to products
directed against Macrophage Migration Inhibitory Factor ("MIF"), and the use of
such products for the potential palliation, evaluation, diagnosis and treatment
and/or prophylaxis of human disease states which are caused or exacerbated by
MIF;
WHEREAS, TAISHO desires to obtain certain licenses from IDEC under the
aforesaid patents, patent applications, and know-how to make and sell such
products, and IDEC is willing to grant to TAISHO such licenses;
WHEREAS, by a Collaborative Development Agreement ("CDA") entered into as
of even date, 1999 between TAISHO and IDEC, both TAISHO and IDEC have agreed to
collaborate in research of antibodies against MIF and development of PRODUCT
(hereinafter defined) in their respective territories; and
WHEREAS, it is the desire of IDEC and TAISHO that PRODUCT developed under
the collaboration and subject to the licenses hereunder be part of a funded and
coordinated development and commercialization plan.
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:
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CONFIDENTIAL TREATMENT REQUESTED
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 LICENSE AGREEMENT 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 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 LICENSE AGREEMENT.
"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 pharmaceutical 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 LICENSE AGREEMENT.
"CDA" shall mean the Collaborative Development Agreement between the
PARTIES of even date.
"CDA INFORMATION" shall mean any and all proprietary or confidential data,
information, know-how and results obtained from the research and development
under the CDA, [CONFIDENTIAL TREATMENT REQUESTED] with exception that TAISHO
obtains manufacturing rights of PRODUCT or FINISHED PRODUCT under Section 10.02.
"CO-PROMOTION" shall mean, for purposes of this LICENSE AGREEMENT, a way of
collaboration by the PARTIES under which TAISHO, its AFFILIATE or its
sublicensee as one PARTY and IDEC or its 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 its option under
Section 2.03 of this LICENSE AGREEMENT.
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"COMBINATION PRODUCT" shall mean a product which includes PRODUCT and
further comprises one or more other therapeutically or prophylactically active
compositions of matter.
"EMEA" shall mean the European Medicines Evaluation Agency.
"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].
"FINISHED PRODUCT" shall mean PRODUCT formulated in finished form for sale
or use.
"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 the CDA or known to IDEC as of the EFFECTIVE DATE of the CDA.
"IDEC TERRITORY" shall mean the entire world, except TAISHO TERRITORY.
"KNOW-HOW" shall mean all proprietary or confidential information, data and
know-how which relates to PRODUCT and FINISHED PRODUCT and shall include,
without limitation, all chemical, pharmacological, toxicological, clinical,
assay, quality control and manufacturing data (but shall not include
manufacturing know-how) and any other information and REAGENTS relating to
PRODUCT and FINISHED PRODUCT and commercialization of PRODUCT and FINISHED
PRODUCT for any indication within the FIELD, developed during the term of this
LICENSE AGREEMENT 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
LICENSE AGREEMENT. In addition, the term "KNOW-HOW" shall include CDA
INFORMATION.
"MAJOR EUROPEAN COUNTRY" shall mean any one of the following
countries:[CONFIDENTIAL TREATMENT REQUESTED].
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CONFIDENTIAL TREATMENT
"NET SALES" shall mean the gross receipts from sales of FINISHED PRODUCT in
the FIELD and TAISHO TERRITORY by TAISHO or its sublicensees to any unrelated
THIRD PARTY under this LICENSE AGREEMENT, less deductions for (i) transportation
charges, including insurance; (ii) sales, excise and consumption taxes paid or
allowed by TAISHO and any other governmental charges imposed upon the
production, importation, use or sale of such FINISHED PRODUCT; (iii) normal and
customary trade, quantity and cash discounts, rebates and chargebacks allowed
and actually taken; and (iv) allowances or credits to customers on account of
rejection or return of FINISHED PRODUCT subject to royalty under this LICENSE
AGREEMENT. Sales between or among TAISHO and its AFFILIATES shall be excluded
from the computation of NET SALES except where such AFFILIATES are end users,
but NET SALES shall include the subsequent final sales to THIRD PARTIES by such
AFFILIATES.
"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 have, now or in the future, the right to use, grant
licenses or sublicenses during the term of this LICENSE AGREEMENT, which
generically or specifically claim PRODUCT, FINISHED PRODUCT or REAGENT, a
process for manufacturing PRODUCT, FINISHED PRODUCT or REAGENT, an intermediate
used in such process, a method to formulate or deliver PRODUCT, FINISHED PRODUCT
or REAGENT or a use of PRODUCT, FINISHED 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, FINISHED PRODUCT
or REAGENT, including the use of PRODUCT or REAGENT, or intermediates or
manufacturing processes required or useful for production of PRODUCT, FINISHED
PRODUCT or REAGENT which are developed by a PARTY, or which such PARTY otherwise
has the right to use, grant licenses or sublicenses, now or in the future,
during the term of this LICENSE AGREEMENT. The current list of patent
applications and patents encompassed within IDEC's PATENTS is set forth
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CONFIDENTIAL TREATMENT
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 whose status 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 PARTY, and to which either
PARTY has the right to grant a license or sublicenses to the other PARTY in
accordance with ARTICLE 2 of this LICENSE AGREEMENT as of the EFFECTIVE DATE or
acquires such right during the term of this LICENSE AGREEMENT, which composition
of matter contains antibodies against MIF.
"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 the CDA or known to TAISHO as of the EFFECTIVE DATE
of the 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, Pakistan, Cambodia, Vietnam, 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 Section 4.01 or 5.05,
such country shall be eliminated from the TAISHO TERRITORY-A.
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"TAISHO TERRITORY-B" shall mean the United Kingdom, Germany, France, Spain,
Italy, Portugal, Switzerland, the Netherlands, Norway, Australia, New Zealand,
Yugoslavia, Romania, Russian Federation, Slovak Republic, Czech Republic,
Denmark, Hungary, Finland, Bulgaria, Belgium, 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,
Marshall Islands, Federated States of Micronesia, United Arab Emirates, Israel,
Iraq, Iran, Kuwait, Saudi Arabia, Turkey, Azerbaijan, Afganistan, Armenia,
Yemen, Uzbekistan, Oman, Kazakhstan, Qatar, Cyprus, Kyrgyzstan, Georgia, Syria,
Tajikistan, 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 Section 4.01 or 5.05, such country
shall be eliminated from the TAISHO TERRITORY--B.
"THIRD PARTY(IES)" shall mean any party other than a PARTY to this LICENSE
AGREEMENT or an AFFILIATE of TAISHO or IDEC.
ARTICLE 2
GRANTS
2.01 TAISHO License. IDEC hereby grants to TAISHO a perpetual, exclusive
license, with the right to grant sublicenses, under IDEC's PATENTS and KNOW-HOW
to make, have made, use, sell and have sold PRODUCT and FINISHED PRODUCT within
the FIELD and TAISHO TERRITORY.
2.02 IDEC License. TAISHO hereby grants to IDEC a perpetual, co-exclusive
(with TAISHO) license under TAISHO PATENTS and KNOW HOW to make, have made, use,
and sell PRODUCT and FINISHED PRODUCT within the FIELD and TAISHO TERRITORY in
the case and the country where IDEC selected the conversion to a perpetual
co-exclusive license in Section 2.03.
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CONFIDENTIAL TREATMENT REQUESTED
2.03 Option for Co-Exclusive by Territory. IDEC shall have the option to
convert at its discretion at any time before expiration of sixty (60) days from
completion of the [CONFIDENTIAL TREATMENT REQUESTED], the exclusive license
throughout the TAISHO TERRITORY-B granted under Section 2.01 (subject to the
limitations set forth in this Section 2.03), to a perpetual co-exclusive license
with the right to sublicense, on a country-by-country basis within TAISHO
TERRITORY-B (with only IDEC or IDEC's AFFILIATE) under IDEC's PATENTS and
KNOW-HOW to make, have made, use, sell and have sold PRODUCT and FINISHED
PRODUCT within the FIELD. Such co-exclusive license shall be implemented by
entering into an agreement for CO-PROMOTION, the non-financial terms and
conditions of which shall be finally negotiated before the initiation of
[CONFIDENTIAL TREATMENT REQUESTED]. In the event IDEC does not exercise such
option for a co-exclusive license before the end of the above sixty (60) days
period in TAISHO TERRITORY-B, TAISHO may seek a partner in TAISHO TERRITORY-B,
for developing or marketing of FINISHED PRODUCT including an arrangement for
co-promotion. However, if TAISHO has not secured a partner for marketing and
promotion of PRODUCT in TAISHO TERRITORY-B, (i.e. this means that no written
agreement between third party and TAISHO is executed ) by the latter of
completion of [CONFIDENTIAL TREATMENT REQUESTED], in which case, IDEC shall
notify in writing TAISHO of its intention to exercise such first negotiation
right. IDEC shall have the first right to negotiate a partnership agreement for
a period of [CONFIDENTIAL TREATMENT REQUESTED]. Thereafter, TAISHO may enter
into a partnership agreement, provided that the terms are not less favorable to
TAISHO than the terms last offered IDEC. In the event IDEC elects to CO-PROMOTE
in any country in TAISHO TERRITORY-B, any sublicensing in such country in TAISHO
TERRITORY-B shall be subject to IDEC's approval, which approval will not be
unreasonably withheld or delayed. On sixty (60) days written notice, IDEC having
exercised the co-exclusive option may renounce its rights to the co-exclusive
license in its entirety and vest exclusive license rights in TAISHO. Upon any
such renouncement of co-exclusive rights by IDEC, payments shall revert to the
exclusive payment schedule set forth in Section 3.02(a) hereof. However, TAISHO
shall not be required to make up the difference for any past milestone payments
under the co-exclusive license payment under Section 3.02(b) as compared with
milestone payments for exclusive license under Section 3.02(a). If IDEC
exercises its option under this Section 2.03 to convert to a co-exclusive
license
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CONFIDENTIAL TREATMENT REQUESTED
in TAISHO TERRITORY-B, but later chooses to opt out, no reimbursement of royalty
payments or fees shall be due TAISHO.
2.04 In case IDEC has exercised its option as provided under Section 2.03,
either PARTY may not grant licenses or sublicenses to its co-exclusive rights
under Section 2.03 to THIRD PARTIES for TAISHO TERRITORY-B, except for the
purpose of entering into collaborative development agreements between any such
THIRD PARTY and IDEC or TAISHO that provide the support, as is appropriate at
the time, for research, development and/or commercialization of PRODUCT, or as
otherwise agreed to by the PARTIES in writing.
2.05 This LICENSE AGREEMENT shall not be construed to grant any rights or
licenses other than those specifically and unambiguously granted hereunder.
Except as provided herein, this License Agreement shall not be construed to
grant manufacturing rights.
ARTICLE 3
PAYMENTS
3.01 As consideration for the license under IDEC's PATENTS and KNOW-HOW
granted to TAISHO under this LICENSE AGREEMENT, TAISHO shall pay to IDEC the
following payments described in Article 3.
3.02 (a) To IDEC--Under TAISHO TERRITORY-A AND TAISHO TERRITORY-B. If
TAISHO maintains its exclusive license in the TAISHO TERRITORY-A, and TAISHO
TERRITORY-B and IDEC elects not to exercise its option under Section 2.02
hereof, TAISHO shall pay IDEC a royalty of [CONFIDENTIAL TREATMENT REQUESTED] on
NET SALES of FINISHED PRODUCT for the [CONFIDENTIAL TREATMENT REQUESTED] of the
PRODUCT in each country and [CONFIDENTIAL TREATMENT REQUESTED]. TAISHO shall
further make payments to IDEC as follows:
<Milestone Payments for Exclusive License>
1. Within thirty (30) days of Initiation of Phase II [CONFIDENTIAL
testing of the first PRODUCT in the United States TREATMENT REQUESTED]
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CONFIDENTIAL TREATMENT REQUESTED
[CONFIDENTIAL
TREATMENT REQUESTED]
2. Within thirty (30) days of Initiation of the first
PIVOTAL TRIAL or Phase III testing of the first PRODUCT
3. Within thirty (30) days of BLA Filing of the first [CONFIDENTIAL
PRODUCT in U.S.A. TREATMENT REQUESTED]
(b) If IDEC, under TAISHO TERRITORY-B of co-exclusive license, elects
a co-exclusive license within TAISHO TERRITORY-B under Section 2.03 before
expiration of sixty (60) days from completion of the last patient of the first
multidose Phase I clinical testing, the PARTIES shall share [CONFIDENTIAL
TREATMENT REQUESTED] all of the FINISHED PRODUCT commercialization costs and
profits, on a country-by-country basis, in such countries in TAISHO TERRITORY-B
where IDEC (or an IDEC AFFILIATE) shall implement CO-PROMOTION with TAISHO (or a
TAISHO sublicensee) If IDEC exercises its option for a co-exclusive license
within the TAISHO TERRITORY-B under Section 2.03 before expiration of sixty
(60) days from completion of the [CONFIDENTIAL TREATMENT REQUESTED] hereof,
thereafter TAISHO shall make payments to IDEC according to the following
schedule instead of Section 3.02 (a):
<Milestone Payment for Co-Exclusive License>
1. Initiation of Phase II testing of the first PRODUCT [CONFIDENTIAL
in the United States TREATMENT REQUESTED]
2. Initiation of PIVOTAL TRIAL or Phase III testing of [CONFIDENTIAL
the first PRODUCT TREATMENT REQUESTED]
3. BLA Filing of the first PRODUCT in U.S.A. [CONFIDENTIAL
TREATMENT REQUESTED]
3.03 To Third Parties. In addition, TAISHO shall be responsible for all
royalty payments made to THIRD PARTIES (excluding royalties to Cytokine
Networks, Inc.), for licenses to certain enabling technologies in its exclusive
TAISHO TERRITORY, royalty in co-exclusive country in TAISHO TERRITORY-B shall be
[CONFIDENTIAL TREATMENT REQUESTED] between the PARTIES.
3.04 The provisions of Article 3 shall apply to only the first PRODUCT and
to the extent this LICENSE AGREEMENT is effective. TAISHO and IDEC shall
negotiate in good faith the terms for the collaboration of second generation
products which mean back-up anti-MIF antibodies other than those described in
APPENDIX B and APPENDIX C of the CDA [CONFIDENTIAL TREATMENT REQUESTED].
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3.05 Determination of royalties for NET SALES of any COMBINATION PRODUCT
shall be mutually agreed upon by the PARTIES.
3.06 IDEC shall provide TAISHO at the time of payment or upon request by
TAISHO with supporting documents of expenses incurred by IDEC under this Article
3.
ARTICLE 4
DEVELOPMENT AND COMMERCIALIZATION IN TAISHO TERRITORY
4.01 TAISHO will use BEST EFFORTS and diligence to develop and
commercialize the PRODUCT in each country of TAISHO TERRITORY in which
regulatory approval is granted, taking into account the scientific and
commercial potential for PRODUCT, including without limitation each of the
potential indications therefor. TAISHO agrees to provide promotional support, a
sales force, medical education, and at all times be prepared to outline in
detail its selling time, expenditures, promotional and direct mail efforts,
journal ads, and medical education efforts. If TAISHO elects to abandon,
discontinue, or forego development and/or commercialization of any PRODUCT for
all indications of such PRODUCT in any country in TAISHO TERRITORY-A or TAISHO
TERRITORY-B, or fails after a reasonable period of time to initiate such
development and commercialization, in such country TAISHO's licenses under
ARTICLE 2 to such PRODUCT, including without limitation, and COMBINATION PRODUCT
thereof, shall terminate and the rights 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 TAISHO TERRITORY-A or TAISHO
TERRITORY-B.
4.02 If TAISHO is not interested in developing or launching PRODUCT for a
particular indication in any country in the TAISHO TERRITORY-A or TAISHO
TERRITORY-B or fails after a reasonable period of time to initiate such
development in such country, and the PARTIES reasonably determine that the
commercialization of such indication will not adversely impact TAISHO's
commercialization activities under this LICENSE AGREEMENT, then TAISHO shall
promptly give IDEC its written consent to permit IDEC to develop and
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commercialize such indication in such terminated country alone or with any THIRD
PARTY, which consent shall not be unreasonably withheld or delayed.
4.03 TAISHO shall have no obligation for the PRODUCT or country where
TAISHO's rights terminated under Section 4.01 or 4.02.
ARTICLE 5
TERM AND TERMINATION
5.01 This LICENSE AGREEMENT shall come into force on EFFECTIVE DATE and
shall, unless the CDA is earlier terminated according to its provisions or this
LICENSE AGREEMENT is earlier terminated hereunder, continue to be in effect on a
country-by-country basis until [CONFIDENTIAL TREATMENT REQUESTED]. The terms of
this LICENSE AGREEMENT shall continue to be in effect after expiration of the
CDA.
5.02 TAISHO's royalty obligations for a particular FINISHED PRODUCT under
Section 3.01 in each country of the TAISHO TERRITORY shall expire on a
country-by-country basis upon [CONFIDENTIAL TREATMENT REQUESTED] in each such
country in the TAISHO TERRITORY in which a FINISHED PRODUCT is marketed by or
for TAISHO regardless of existing or non-existing of PATENTS or number of
PATENTS; [CONFIDENTIAL TREATMENT REQUESTED]. This LICENSE AGREEMENT shall
terminate country-by-country basis upon expiration of this royalty period
including EXTENSION PERIOD. Expiration of this royalty period in any country
under this provision shall not preclude TAISHO from continuing to market any
PRODUCT and FINISHED PRODUCT and to use KNOW-HOW in such country without further
royalty payments.
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5.03 If the CDA is earlier terminated due to reasons other than IDEC's
default or its insolvency, this LICENSE AGREEMENT shall be automatically
terminated.
5.04 If either PARTY materially fails or neglects to perform its
obligations, except a case beyond its control, set forth in this LICENSE
AGREEMENT 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 LICENSE
AGREEMENT by giving written notice to the PARTY in default provided the notice
of termination is given within [CONFIDENTIAL TREATMENT REQUESTED] of when the
default becomes known to such PARTY and prior to correction of the default, in
which case terminating PARTY shall have the rights to continue and to market any
PRODUCT and FINISHED PRODUCT without any further obligation to the other PARTY.
5.05 TAISHO may terminate this LICENSE AGREEMENT in its entirety or a
particular country by giving IDEC at least [CONFIDENTIAL TREATMENT REQUESTED]
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 LICENSE AGREEMENT with respect to
any country in the TAISHO TERRITORY under this provision shall terminate all
licenses vested to TAISHO in such country under ARTICLE 2 with full reversion to
IDEC of all IDEC's interest and rights in IDEC's PATENT and KNOW-HOW in such
country and TAISHO shall have no further obligation to IDEC for such terminated
country.
5.06 Either PARTY may terminate this LICENSE AGREEMENT 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 sixty (60) days
after the filing thereof, or if the other
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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.
5.07 Notwithstanding the bankruptcy of a PARTY, or the impairment of
performance by a PARTY of its obligations under this LICENSE AGREEMENT as a
result of bankruptcy or insolvency of such PARTY, the non-bankrupt PARTY shall
be entitled to retain the licenses vested herein, subject to bankrupt PARTY's
rights to terminate this LICENSE AGREEMENT for reasons other than bankruptcy or
insolvency as expressly provided in this LICENSE AGREEMENT, and subject to
performance by the non-bankrupt PARTY of its preexisting obligations under this
LICENSE AGREEMENT.
ARTICLE 6
RIGHTS AND DUTIES UPON TERMINATION
6.01 Upon termination of this LICENSE AGREEMENT, 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.
6.02 Termination of this LICENSE AGREEMENT shall terminate all rights and
further obligations between the PARTIES arising from this LICENSE AGREEMENT,
provided, however those described in Sections 7.01, 7.02, 7.04, 7.05, 7.06,
7.07, and 7.08 for data or other information generated or provided by either
PARTY during the term of the LICENSE AGREEMENT, Sections 5.02, 5.04, 5.05, 5.07,
6.01 through 6.04, 8.02 and ARTICLES 9, 10, 11, 12, 13, 15, 16, 19 and 20, and
existing rights against the other PARTY for a breach by that PARTY shall survive
any termination of this LICENSE AGREEMENT.
6.03 Termination of this LICENSE AGREEMENT under Section 5.04 for a default
by IDEC shall terminate TAISHO's obligation to make any remaining payments
required by this LICENSE AGREEMENT 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 LICENSE AGREEMENT with respect to
all countries of the TERRITORY under Section 5.05 shall
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terminate TAISHO's obligation to make any remaining payments required by this
LICENSE AGREEMENT including ARTICLE 3 for periods after the effective date of
termination.
6.04 All rights to terminate, and rights upon termination, provided for
either PARTY in this LICENSE AGREEMENT are in addition to other remedies in law
or equity which may be available to either PARTY.
ARTICLE 7
EXCHANGE OF INFORMATION AND CONFIDENTIALITY
7.01 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, prior to IND filing, establish a joint
written pharmacovigilence policy that complies with the International Committee
for Harmonization.
7.02 Each PARTY shall promptly inform the other PARTY of any information
that it obtains or develops in any country of the world regarding the safety of
PRODUCT or FINISHED PRODUCT and 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 or FINISHED PRODUCT. In
this regard, each PARTY agrees that, throughout the duration of this LICENSE
AGREEMENT and thereafter, it will notify the other PARTY immediately of any
information concerning any PRODUCT or FINISHED PRODUCT or package complaint, or
any serious or unexpected animal or human side effect, injury, toxicity or
sensitivity reaction or any unexpected incidence or severity thereof associated
with the preclinical studies as well as clinical uses, studies, investigations,
tests and marketing of PRODUCT or FINISHED PRODUCT, whether or not determined to
be attributable to PRODUCT or FINISHED PRODUCT. "Serious" as used in this
Section refers to experience
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which results in death, permanent or substantial disability, in-patient
hospitalization, prolongation of existing in-patient hospitalization; or is a
congenital anomaly, cancer, the result of an overdose 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 or FINISHED PRODUCT; (ii)
conditions or developments not encountered during clinical studies of PRODUCT or
FINISHED PRODUCT; and (iii) 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 or FINISHED PRODUCT, whether
or not considered related thereto.
7.03 Each PARTY shall 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 FINISHED PRODUCT or the continued development or marketing of PRODUCT
or FINISHED PRODUCT. Upon receipt of any such information, a 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.
7.04 The PARTIES agree throughout the duration of this LICENSE AGREEMENT to
maintain records and otherwise establish procedures to assure material
compliance with all regulatory, professional or other legal requirements that
apply to the development, promotion and marketing of PRODUCT or FINISHED
PRODUCT.
7.05 Neither TAISHO nor IDEC may, during the term of this LICENSE AGREEMENT
and for a period of [CONFIDENTIAL TREATMENT REQUESTED] after the later date of
expiration or termination of this LICENSE AGREEMENT, disclose or reveal to THIRD
PARTIES any KNOW-HOW
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CONFIDENTIAL TREATMENT
received from the other PARTY which relates substantially to a PRODUCT or
FINISHED PRODUCT, except that such other PARTY may use or disclose such KNOW-HOW
for the purposes of investigating, developing, manufacturing, marketing or
seeking partners for PRODUCT or FINISHED PRODUCT 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 FINISHED PRODUCT or to carry
out any litigation concerning PRODUCT or FINISHED 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 LICENSE AGREEMENT or the 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; any such
exception must be demonstrated by written proof. The PARTIES shall take
reasonable measures to ensure that no unauthorized use or disclosure is made by
others to whom access to such information is granted.
7.06 Nothing herein shall be construed as preventing either PARTY from
disclosing any information received from the other PARTY to a sublicensee of the
receiving PARTY, provided such sublicensee has undertaken a similar obligation
of confidentiality with respect to the KNOW-HOW.
7.07 The PARTIES agree that the formal initiation of this LICENSE AGREEMENT
will likely 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.
Such a press release shall be prepared by IDEC or TAISHO and reviewed in good
faith and approved by TAISHO or IDEC concurrently with the review and approval
of this LICENSE AGREEMENT.
Notwithstanding the foregoing, no public announcement or other disclosure
to THIRD PARTIES concerning the terms of this LICENSE AGREEMENT shall be made,
either directly or indirectly, by either PARTY to this LICENSE AGREEMENT, 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
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CONFIDENTIAL TREATMENT REQUESTED
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.
7.08 Nothing in this LICENSE AGREEMENT 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 or FINISHED PRODUCT in any manner it reasonably deems appropriate,
including, for example, by disclosing to regulatory authorities confidential or
other information received from each other PARTY or THIRD PARTIES.
ARTICLE 8
INVENTIONS, PATENTS AND PATENT PROSECUTION
8.01 IDEC shall disclose to TAISHO as KNOW-HOW the complete texts of all
PATENTS filed by IDEC prior to the EFFECTIVE DATE as well as all information
received concerning the institution or possible institution of any interference,
opposition, re-examination, reissue, revocation, nullification or any official
proceeding involving a PATENT anywhere in the TAISHO TERRITORY. TAISHO shall
have the right to review all such PATENTS and all proceedings related thereto
and make recommendations to IDEC concerning them and their conduct. IDEC agrees
to keep TAISHO fully informed of the course of patent prosecution or other
proceedings of such PATENTS including providing TAISHO with copies of
substantive communications, search reports and THIRD PARTY observations
submitted to or received from patent offices within the TAISHO TERRITORY. TAISHO
shall provide such patent consultation to IDEC related to such PATENTS at no
cost to IDEC. TAISHO shall reimburse IDEC for the reasonable out-of-pocket costs
IDEC has incurred or will incur in filing, prosecuting and maintaining such
PATENTS in the TAISHO TERRITORY, provided that, such reasonable out-of-pocket
costs for any country in TAISHO TERRITORY-B for which IDEC has determined to
implement CO-PROMOTION shall be shared [CONFIDENTIAL TREATMENT REQUESTED]
between IDEC and TAISHO. TAISHO shall hold all information disclosed to it under
this Section as confidential subject to the provisions of ARTICLE 7 of this
LICENSE AGREEMENT. IDEC shall diligently
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prosecute and maintain such PATENTS in the TAISHO TERRITORY. TAISHO shall at its
full discretion have the right to assume responsibility for any PATENT or any
part of any PATENT which IDEC intends to abandon or otherwise cause or allow to
be forfeited.
8.02 Each PARTY shall have and retain sole and exclusive title to all
inventions, discoveries and patentable CDA INFORMATION which are made,
conceived, reduced to practice and generated solely by its employees or agents
in the course of or as a result of the research and development under the CDA or
during the term of this LICENSE AGREEMENT. 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
research and development under the CDA or during the term of this LICENSE
AGREEMENT. Inventorship of inventions, discoveries and patentable CDA
INFORMATION shall be subject to and determined by the patent laws of the country
where the patent applications are filed.
8.03 (a) Upon the making, conceiving or reducing to practice of any
invention or discovery by a PARTY as referred to in Section 8.02, 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 by IDEC or jointly by TAISHO and IDEC in countries of IDEC's choice
throughout the world, with appropriate credit to TAISHO representatives,
including the naming of such representatives 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 reimburse IDEC for the reasonable out-of-pocket costs
IDEC incurs in filing, prosecuting and maintaining such PATENTS in the TAISHO
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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 7 of this
LICENSE AGREEMENT. TAISHO shall at its full discretion have the right to assume
responsibility for any such PATENT or any part of 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 TAISHO TERRITORY.
Notwithstanding foregoing any and all activities of filing, prosecuting and
maintaining a PATENT 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 throughout the world, 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 7 of this LICENSE AGREEMENT. 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
IDEC TERRITORY.
(b) If IDEC, prior or subsequent to filing certain PATENTS on
such inventions or discoveries which are owned in part by TAISHO, elects not to
file, 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,
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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 to file, 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.
(c) 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.
8.04 Notwithstanding the provisions of Section 8.03, 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 8.02 hereof and
shall execute all documents deemed necessary or desirable therefor.
ARTICLE 9
PATENT LITIGATION
9.01 In the event of the institution of any suit for patent infringement by
a THIRD PARTY against IDEC, TAISHO and/or its sublicensees involving the
manufacture, use, sale, distribution or marketing of PRODUCT or FINISHED
PRODUCT, the PARTY sued shall promptly notify the other PARTY in writing. Either
PARTY sued shall have the right but not the obligation to defend such suit at
its own expense. IDEC and TAISHO shall assist one another and cooperate in any
such litigation to a reasonable extent at the other's request without expense to
the requesting PARTY.
9.02 In the event that IDEC or TAISHO becomes aware of actual or threatened
infringement of a PATENT related to PRODUCT or FINISHED PRODUCT, that PARTY
shall
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CONFIDENTIAL TREATMENT
promptly notify the other PARTY in writing. IDEC shall undertake reasonable
evaluation of such infringing activity and have the first right but not the
obligation to bring, at its own expense, an infringement action or file any
other appropriate action or claim directly related to infringement of a PATENT
owned in whole or in part by IDEC, wherein such infringement relates to PRODUCT
or FINISHED PRODUCT, against any THIRD PARTY and as the case may be to use
TAISHO's name in connection therewith. If IDEC does not commence a particular
infringement action within one hundred and twenty (120) days after it received
such written notice, TAISHO, after notifying IDEC in writing, shall be entitled
but not the obligation to bring such infringement action or any other
appropriate action or claim at its own expense. TAISHO shall undertake
reasonable evaluation of such infringing activity and have the first right but
not the obligation to bring, at its own expense, an infringement action or file
any other appropriate action or claim directly related to infringement of a
PATENT owned in whole by TAISHO, wherein such infringement relates to PRODUCT or
FINISHED PRODUCT, against any THIRD PARTY and as the case may be to use IDEC's
name in connection therewith. If TAISHO does not commence a particular
infringement action within one hundred and twenty (120) days after it received
such written notice, IDEC, after notifying TAISHO in writing, shall be entitled
but not the obligation to bring such infringement action or any other
appropriate action or claim at its own expense. The PARTY conducting such action
shall have full control over its conduct. In any event, IDEC and TAISHO shall
assist one another and cooperate in any such litigation to a reasonable extent
at the other's request without expense to the requesting PARTY.
9.03 IDEC and TAISHO shall recover their respective actual out-of-pocket
expenses, or equitable proportions thereof, associated with any litigation or
settlement thereof from any recovery made by any PARTY. Any excess amount shall
be shared between TAISHO and IDEC, with each PARTY receiving an amount
proportional to the amount spent by such PARTY on such litigation or settlement
thereof relative to the total amount spent by both PARTIES on such litigation or
settlement thereof. Neither PARTY shall settle any dispute with any alleged
infringer without the prior written consent of the other PARTY, and such written
consent shall not be unreasonably withheld.
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9.04 The PARTIES shall keep one another informed of the status of and of
their respective activities regarding any litigation or settlement thereof
concerning PRODUCT or FINISHED PRODUCT.
ARTICLE 10
PRODUCT SUPPLY
10.01 During commercialization of the PRODUCT under the LICENSE AGREEMENT,
IDEC shall manufacture, at TAISHO's request and at [CONFIDENTIAL TREATMENT
REQUESTED], and supply TAISHO's clinical (excluding preclinical studies and
clinical trials described in Section 7.01 of the CDA) and commercial
requirements of PRODUCT manufactured under GMP guidelines.
10.02 TAISHO's Manufacturing Rights:
(a) TAISHO TERRITORY-A TAISHO shall have the right and option to elect
to manufacture by itself and/or have manufactured by its AFFILIATES PRODUCT or
FINISHED PRODUCT in TAISHO TERRITORY-A, provided that [CONFIDENTIAL TREATMENT
REQUESTED]. If TAISHO fulfills the above requirements and elects to manufacture,
IDEC shall only be obligated to [CONFIDENTIAL TREATMENT REQUESTED]. TAISHO
warrants that under these circumstances, it will negotiate for and secure all
licenses necessary to manufacture PRODUCT or FINISHED PRODUCT. IDEC shall
provide assistance that it feels is reasonably necessary for TAISHO to secure
all licenses necessary to manufacture PRODUCT or FINISHED PRODUCT.
[CONFIDENTIAL TREATMENT REQUESTED], TAISHO may then manufacture or
sublicense the right to manufacture bulk drug of the PRODUCT or FINISHED PRODUCT
to a THIRD PARTY for commercial purpose in
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CONFIDENTIAL TREATMENT REQUESTED
TAISHO TERRITORY-A. [CONFIDENTIAL TREATMENT REQUESTED]. TAISHO shall be
responsible for providing adequate facilities and trained personnel as well as
the procedures for establishment and compliance with Japanese or EMEA regulatory
requirements for such manufacturing and being granted license (if required) of
any process or facility. Such process transfer shall, for example, be achieved
by mail, facsimile, or at meetings in San Diego. [CONFIDENTIAL TREATMENT
REQUESTED].
(b) TAISHO TERRITORY-B If IDEC does not elect to CO-PROMOTE in TAISHO
TERRITORY-B, TAISHO shall have the same manufacturing rights and obligations in
TAISHO TERRITORY-B as it does in TAISHO TERRITORY-A. TAISHO warrants that under
the circumstances, it will negotiate for and secure all licenses necessary to
manufacture PRODUCT or FINISHED PRODUCT in TAISHO TERRITORY-B. However, if IDEC
elects to CO-PROMOTE in TAISHO TERRITORY-B, IDEC shall retain all rights to
manufacture PRODUCT and FINISHED PRODUCT.
[CONFIDENTIAL TREATMENT REQUESTED], TAISHO may then manufacture or
sublicense the right to a THIRD PARTY to manufacture bulk drug of PRODUCT or
FINISHED PRODUCT for commercial purpose in TAISHO TERRITORY-B.
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CONFIDENTIAL TREATMENT REQUESTED
[CONFIDENTIAL TREATMENT REQUESTED]. TAISHO shall be responsible for providing
adequate facilities and trained personnel as well as the procedures for
establishment and compliance with Japanese or EMEA regulatory requirements for
such manufacturing and being granted license (if required) of any process or
facility. Such process transfer shall, for example, be achieved by mail,
facsimile, or at meetings in San Diego. [CONFIDENTIAL TREATMENT REQUESTED].
ARTICLE 11
TRADEMARKS AND TRADENAMES
11.01 Nothing in this LICENSE AGREEMENT shall be construed as a grant of
rights, by license or otherwise, to a PARTY to use trademarks and tradenames
owned by the other PARTY for any purpose.
11.02. Nothing in this LICENSE AGREEMENT shall be construed as a grant of
rights, by license or otherwise, to either PARTY, to use the name of the other
PARTY or its AFFILIATES for any purpose whatsoever except as may otherwise be
expressly provided for in this LICENSE AGREEMENT.
ARTICLE 12
STATEMENTS AND REMITTANCES
12.01 TAISHO shall keep and require its AFFILIATES or sublicensees to keep
complete and accurate records of all sales of FINISHED PRODUCT under the
licenses granted herein. IDEC shall have the right, at IDEC's expense, through a
certified public accountant or
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CONFIDENTIAL TREATMENT
like person reasonably acceptable to TAISHO, to examine such records during
regular business hours during the life of this LICENSE AGREEMENT and for one (1)
year after the later of its termination or the last sale of FINISHED PRODUCT by
TAISHO subject to the royalty obligations outlined in Section 3.02; provided,
however, that such examination shall not take place more often than once a year
and shall not cover such records for more than the preceding two (2) years and
provided further that such accountant shall report to IDEC only as to the
accuracy and completeness of the royalty statements and payments.
12.02 Within sixty (60) days after the close of each calendar quarter,
TAISHO shall deliver to IDEC a true accounting of all FINISHED PRODUCT sold by
TAISHO and its AFFILIATES or sublicensees during such quarter and shall at the
same time pay all royalties due. Such accounting shall show sales on a
country-by-country and FINISHED PRODUCT-by-FINISHED PRODUCT basis.
12.03 Any tax paid or required to be withheld by TAISHO on any payment
payable to IDEC under this LICENSE AGREEMENT shall be deducted from the amount
of payments otherwise due. TAISHO shall secure and send to IDEC written proof of
any such taxes withheld and paid by TAISHO or its AFFILIATES for the benefit of
IDEC in a form sufficient to satisfy the United States Internal Revenue Service.
12.04 All royalties due under this LICENSE AGREEMENT shall be payable in
U.S. dollars. If governmental regulations prevent remittances from a country of
the TAISHO TERRITORY to any other country with respect to sales made in that
country, the obligation of TAISHO to pay royalties on sales in that country
shall be suspended until such remittances are possible, and once they are
possible, TAISHO shall pay IDEC any back royalties which may be owed.
Alternatively, IDEC shall have the right, upon giving written notice to TAISHO,
to receive payment in that country in local currency.
12.05 Monetary conversions from the currency of a foreign country, in
which FINISHED PRODUCT is sold, into United States currency shall be made at the
average of selling and buying official exchange rate as certified by Citibank,
N.A., New York, New York, U.S.A. for financial transactions in that country on
the last business day of the calendar quarter for which the royalties are being
paid.
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ARTICLE 13
WARRANTIES, REPRESENTATIONS, INSURANCE
AND INDEMNIFICATIONS
13.01 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 PATENTS and KNOW-HOW, or has the right to use, and grant
the license outlined in ARTICLE 2 with respect to PATENTS and KNOW-HOW, and has
the right to enter into this LICENSE AGREEMENT.
13.02 NOTHING IN THIS LICENSE AGREEMENT 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.
13.03 IDEC warrants and represents that it has no present knowledge of the
existence of any pre-clinical 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.
13.04 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 its AFFILIATES); 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:
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CONFIDENTIAL TREATMENT
(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;
(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 LICENSE AGREEMENT, (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.
13.05 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 LICENSE
AGREEMENT, including, but not limited to, IDEC's activities related to any
breach of a representation or warranty made to TAISHO by IDEC under this LICENSE
AGREEMENT. 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
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CONFIDENTIAL TREATMENT
of action referred to in this Section utilizing attorneys of its choice;
however, 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 TAISHO seeks indemnification under this
Section.
13.06 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 LICENSE
AGREEMENT, including, but not limited to, any breach of a representation or
warranty made to IDEC by TAISHO under this LICENSE AGREEMENT. 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.
13.07 Notwithstanding anything else in this LICENSE AGREEMENT, the CDA or
otherwise, neither PARTY will be liable with respect to any subject matter of
this LICENSE AGREEMENT 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 LICENSE AGREEMENT and the CDA, for any
incidental or consequential damages, or for cost of procurement of substitute
goods, technology, or services.
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ARTICLE 14
FORCE MAJEURE
14.01 If the performance of any part of this LICENSE AGREEMENT by either
PARTY, or of any obligation under this LICENSE AGREEMENT, 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 LICENSE AGREEMENT may be
required in order to arrive at an equitable solution.
ARTICLE 15
GOVERNING LAW
15.01 This LICENSE AGREEMENT shall be governed by the laws of the State of
California, U.S.A..
ARTICLE 16
DISPUTE RESOLUTION
16.01 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 LICENSE AGREEMENT, 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 face to face, good faith
negotiations in the U.S. among the PARTIES' respective Chief Executive Officers,
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
29
<PAGE> 34
CONFIDENTIAL TREATMENT
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 16.01. 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 mediation or 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.
16.02 Notwithstanding anything contained in Section 16.01 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.
ARTICLE 17
SEPARABILITY
17.01 In the event any portion of this LICENSE AGREEMENT shall be held
illegal, void or ineffective, the remaining portions hereof shall remain in full
force and effect.
17.02 If any of the terms or provisions of this LICENSE AGREEMENT 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.
17.03 In the event that the terms and conditions of this LICENSE AGREEMENT
are materially altered as a result of Sections 17.01 or 17.02, the PARTIES will
renegotiate the terms and conditions of this LICENSE AGREEMENT to resolve any
inequities.
30
<PAGE> 35
CONFIDENTIAL TREATMENT
ARTICLE 18
ENTIRE AGREEMENT
18.01 This LICENSE AGREEMENT together with the CDA, entered into as of the
EFFECTIVE DATE, constitute 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 LICENSE AGREEMENT 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 LICENSE AGREEMENT by written
instruments specifically referring to and executed in the same manner as this
LICENSE AGREEMENT.
ARTICLE 19
NOTICES
19.01 Any notice required or permitted under this LICENSE AGREEMENT shall
be sent by certified mail, facsimile, or overnight courier service, postage
pre-paid to the following addresses of the PARTIES:
IDEC PHARMACEUTICALS CORPORATION
11011 Torreyana Road
San Diego, California 92121 U.S.A.
Attention: Corporate Secretary
Copy to: President
TAISHO PHARMACEUTICAL CO., LTD.
24-1 Takata 3-chome, Toshima-ku
Tokyo 170-8633, Japan
Attention: Group Manager of Licensing Division
19.02 Any notice required or permitted to be given concerning this LICENSE
AGREEMENT shall be effective upon receipt by the PARTY to whom it is addressed.
31
<PAGE> 36
CONFIDENTIAL TREATMENT
ARTICLE 20
ASSIGNMENT
20.01 This LICENSE AGREEMENT 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 LICENSE AGREEMENT nor any interest hereunder
shall be assignable by either PARTY without the written consent of the other
provided, however, that either PARTY may assign this LICENSE AGREEMENT 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 LICENSE AGREEMENT relates, without obtaining consent
but giving notice to the other PARTY.
ARTICLE 21
RECORDATION
21.01 The PARTIES shall have the right, at any time during the term of
this LICENSE AGREEMENT, to record, register, or otherwise notify this LICENSE
AGREEMENT in any patent office or other appropriate facility anywhere in the
world, and the PARTIES shall provide reasonable assistance to each other in
effecting such recording.
ARTICLE 22
EXECUTION IN COUNTERPARTS
22.01 This LICENSE AGREEMENT 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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CONFIDENTIAL TREATMENT
IN WITNESS WHEREOF, the PARTIES, through their authorized officers, have
executed this LICENSE AGREEMENT.
TAISHO PHARMACEUTICAL CO., LTD.
By: /s/ Akira Uehara
-------------------------------
Title: President
-------------------------------
Date: December 9, 1999
-------------------------------
IDEC PHARMACEUTICALS CORPORATION
By: /s/ William H. Rastetter, Ph.D.
-------------------------------
Title: Chairman, President, and Chief Executive Officer
------------------------------------------------
Date: 12/22/99
-------------------------------
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CONFIDENTIAL TREATMENT REQUESTED
APPENDIX A
PATENT AND PATENT APPLICATIONS
-------------------------------------------------------------------------------------------------
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 TREATMENT
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] REQUESTED]
------------------------- ----------------------- ----------------------- -------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL TREATMENT
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] REQUESTED]
------------------------- ----------------------- ----------------------- -------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL TREATMENT
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] REQUESTED]
------------------------- ----------------------- ----------------------- -------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL TREATMENT
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] REQUESTED]
------------------------- ----------------------- ----------------------- -------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL TREATMENT
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] REQUESTED]
------------------------- ----------------------- ----------------------- -------------------------
[CONFIDENTIAL TREATMENT [CONFIDENTIAL [CONFIDENTIAL [CONFIDENTIAL TREATMENT
REQUESTED] TREATMENT REQUESTED] TREATMENT REQUESTED] REQUESTED]
------------------------- ----------------------- ----------------------- -------------------------
i
<PAGE> 39
CONFIDENTIAL TREATMENT REQUESTED
APPENDIX B
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 procedures for [CONFIDENTIAL TREATMENT REQUESTED].
o Media preparation 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].
2.0 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]
[CONFIDENTIAL TREATMENT REQUESTED] will be based on [CONFIDENTIAL
TREATMENT REQUESTED], and, if required, on [CONFIDENTIAL TREATMENT REQUESTED].
ii
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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].
iii