EXHIBIT 10.42
CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST
FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 OF THE
SECURITIES EXCHANGE ACT OF 1934 AND HAVE BEEN SEPARATELY FILED
WITH THE COMMISSION.
LICENSE AGREEMENT
This LICENSE AGREEMENT (hereinafter called this "License Agreement") made and
effective as of the 7th day of March, 2002 by and between:
Senju Pharmaceutical Co., Ltd., a legal entity duly organized and existing under
the laws of Japan, having its principal office of business at 5-8, Hiranomachi
2-chome, Chuo-ku, Osaka 541-0046, Japan (hereinafter called "SENJU") and;
AcSentient Inc., a legal entity duly organized and existing under the laws of
Delaware, having its principal office of business at 110 Doric Court,
Morrisville, North Carolina 27560, U.S.A. (hereinafter called "ACSENTIENT");
WITNESSETH THAT;
WHEREAS, American Home Products Corporation, state of New Jersey, the United
States of America (and/or its affiliates, including, but not limited to
Wyeth-Ayerst International, Inc., hereinafter collectively called "AHP") is the
owner of technical information and know-how with respect to the chemical
substance [ * ] [ * ], which is known as "bromfenac" (hereinafter called
"Compound");
WHEREAS, SENJU and AHP own jointly patent rights and technical information and
know-how regarding an ophthalmic preparation containing the Compound as an
active ingredient;
WHEREAS, SENJU is the sole exclusive licensee with the right to sub-license the
patent rights and technical information and know-how owned by AHP concerning
Compound for ophthalmologic use and Preparation;
WHEREAS, SENJU has provided ACSENTIENT with some technical information in its
possession pertaining to Preparation under Confidentiality Agreement concluded
between two Parties effective as of the 8th day of August, 2001 and Memorandum
of Understanding Concerning Bromfenac Ophthalmic Product and Timolol LA
Ophthalmic Product of 7th day of January 2002 (hereinafter called "Secrecy
Agreement and MOU" collectively) for ACSENTIENT's evaluation of the feasibility
to commercially develop the Preparation in the Territory (defined in Paragraph
1.02);
WHEREAS, ACSENTIENT is willing to pursue the development of the Preparation in
the Territory subject to the terms and conditions of this License Agreement.
NOW THEREFORE, in consideration of the foregoing, the mutual covenants contained
herein and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, SENJU and ACSENTIENT thereby agree
as follows:
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
(SENJU and ACSENTIENT collectively called "Parties" and/or individually called
"Party")
Article 1 - Definitions
The following terms used in this License Agreement shall have the meanings set
forth in this Article unless the context clearly requires otherwise, and the
singular shall include the plural and vice versa.
1.01 "Patent Rights" shall mean U.S. Patent No. 4,910,225, all divisions,
continuations, continuations-in-part as well as other patents including any
reissues, renewals, extensions or patents of addition thereto.
1.02 "Territory" shall mean United States of America as well as Puerto Rico,
Guam and the U.S. Virgin Islands.
1.03 "Preparation" shall mean any ophthalmic product containing the Compound
as an active ingredient.
1.04 "Technical Information & Know-How" shall mean technical information and
know-how which is available at the Effective Date or becomes available to Senju
during the term of this License Agreement relating to the Preparation, which is
necessary or useful for the practice of the Patent Rights, including without
limitation, the development of the Preparation, obtaining Government Approval
(hereinafter defined) and manufacture of the Preparation in the Territory in
possession of or under the control of Senju. Technical Information & Know-How
shall include any and all technical information and know-how disclosed by SENJU
to ACSENTIENT under Secrecy Agreement and MOU.
1.05 "Net Sales" shall mean the gross invoiced amount charged by ACSENTIENT
or ACSENTIENT Agent to sell the Preparation to Third Parties in the Territory
less (a) ordinary and reasonable trade discounts earned or granted for quantity
purchases, prompt payment discounts and reasonable cash discounts actually
allowed; (b) credits, and allowances actually granted on account of rejections,
returns, rejections, destructions or billing errors; (c) custom duties,
reasonable prepaid out bound transportation expenses and insurance, taxes and
other governmental charges actually paid. Provided, however, that such
reductions will be less than 10% of the gross invoiced price.
1.06 "First Commercialization" shall mean date of the first commercial sale
by ACSENTIENT or ACSENTIENT Agent of the Preparation in commercial quantities to
a Third Party under this License Agreement.
1.07 "Governmental Approval" shall mean any kind of approvals by USFDA (U.
S. Food and Drug Administration) or equivalent future governmental authority,
necessary to commercialize the Preparation in the Territory, including, without
limitation, any approvals necessary to conduct pre-clinical or clinical studies
on the Compound or the Preparation, or necessary for the manufacture,
distribution, and sale of the Preparation.
1.08 "ACSENTIENT Agent" shall mean any agent who sells, markets,
distributes, promotes and offers to sell the Preparation in the Territory on
behalf of ACSENTIENT.
1.09 "ACSENTIENT Manufacturers" shall mean a manufacturer who manufactures
the Preparation in the Territory on behalf of ACSENTIENT.
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
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1.10 "Effective Date" shall mean the date first above written on which this
License Agreement shall become effective.
1.11 "Third Parry" shall mean any party other than SENJU and ACSENTIENT and
ACSENTIENT Manufacturer and ACSENTIENT Agent.
1.12 "Development Activity" shall mean ACSENTIENT's activities to perform
all tests, studies, and other activities necessary to develop the Preparation
and obtain and maintain Government Approval of the Preparation in the Territory.
1.13 "Development Schedule" shall mean a mutually agreeable project
timetable between the Parties for ACSENTIENT's Development Activities, which is
attached hereto as Schedule 1.
1.14 "Trademark" shall mean any trademark, trade dress, brand mark, trade
name, brand name, logo or business symbol to be used in connection with the
marketing of the Preparation in the Territory.
Article 2 - Grant
2.01 SENJU hereby shall grant to ACSENTIENT and ACSENTIENT shall hereby
accept an exclusive, running royalty-bearing license under the Patent Right and
the Technical Information & Know-How to make, have made, import, offer to
provide and provide, develop, manufacture, use, market, sell and offer to sell
the Preparation in the Territory. License granted to ACSENTIENT herein shall not
include the right to grant sub-license in the Territory. SENJU hereby represents
that it has the full right and authority to enter into this License Agreement,
to grant licenses provided herein and to perform its obligations hereunder.
2.02 ACSENTIENT's license granted under this License Agreement shall include
the right to permit ACSENTIENT Manufacturers to practice or use the Patent
Rights and the Technical Information & Know-How to manufacture the Preparation
on behalf of ACSENTIENT and ACSENTIENT Agent to sell, market, distribute,
promote and offer to sell the Preparation on behalf of ACSENTIENT in the
Territory. Provided, however, that ACSENTIENT shall acknowledge and confirm that
by permitting ACSENTIENT Manufacturer and ACSENTIENT Agent to manufacture,
market, sell and offer to sell the Preparation hereunder it shall not be
released from any of its contractual obligations under this License Agreement
and that it shall remain fully responsible for the complete performance of such
obligations under this License Agreement.
2.03 SENJU agrees that during the term of this License Agreement, SENJU nor
its Subsidiaries shall not (a) market or otherwise sell or distribute the
Preparation in the Territory or (b) grant any license to the Patent Rights in
the Territory that would entitle any other party to market or otherwise sell or
distribute during the term of this License Agreement, any product utilizing the
Patent Rights for use in the Territory, except the case where ACSENTIENT's
exclusive right granted by SENJU hereunder reverts to the co-exclusive right
under paragraph 4.02. The term of Subsidiary provided in this paragraph 2.03
shall mean any legal entity fully or substantially fully owned or controlled by
SENJU.
2.04 Within thirty (30) days following the Effective Date and thereafter
during the term of this License Agreement, SENJU agrees to provide ACSENTIENT
with reasonable access to all Technical Information & Know-How, and with copies
of any and all patents and patent applications owned or
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controlled by SENJU covering the Patent Rights or Technical Information &
Know-How, including all patent office actions received and amendments filed, if
any, relative thereto.
Article 3 - Compensation
3.01 In consideration of SENJU's grant of the exclusive license in the
Territory in accordance with the Article 2 hereof, ACSENTIENT shall, during the
term of this License Agreement, pay SENJU the following milestone payments:
Milestone: Amount of Payment due:
(i) Within 60 days from the non refundable license fee of
Effective Date US$750,000.00-
(ii) [ * ] non refundable license fee of
[ * ] [ * ]-
3.02 In the event that ACSENTIENT fails to obtain Governmental Approval
within [ * ] following the scheduled date of such Governmental Approval set
forth in the Development Schedule and such failure is solely attributable to
ACSENTIENT's (including any successor to ACSENTIENT by merger, acquisition or
otherwise) failure to use diligent efforts, [ * ] [ * ] [ * ].
3.03 Unless otherwise provided herein, no payments to Senju under this
License Agreement shall be refundable in whole or in part.
Article 4 - Royalties
4.01 In consideration of the rights granted under this License Agreement,
ACSENTIENT shall pay SENJU as running royalties a sum corresponding to [ * ] of
the Net Sales of the Preparation in the Territory for [ * ] from the First
Commercialization. Thereafter, ACSENTIENT shall pay SENJU as running royalties a
sum corresponding to [ * ] of the Net Sales of the Preparation during the
remaining term of this License Agreement. Provided, however, that if the Net
Sales in any year decreases more than [ * ] compared to the preceding year due
to the commercialization of a generic product equivalent to the Preparation in
the Territory, the running royalty rate shall [ * ] and ACSENTIENT shall pay
SENJU as royalties a sum corresponding to [ * ] of the Net Sales of the
Preparation during the remaining term of this License Agreement.
4.02 Notwithstanding above paragraph 4.01, ACSENTIENT shall pay SENJU
minimum annual royalties of;
(i) US$2,947,425 for the third (3rd) year following the First
Commercialization;
(ii) US$3,264,750 for the fourth (4th) year following the First
Commercialization; and
(iii) US$3,600,600 for the fifth (5th) year following the First
Commercialization:
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
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provided, however, that above minimum annual royalties payment by
ACSENTIENT to SENJU shall be subject to the existence of following conditions
for the Preparation:
(a) The First Commercialization has occurred;
(b) The Preparation has obtained Governmental Approval
usable for [ * ] [ * ];
(c) The Preparation is not associated with [ * ]
(provided that both Parties confirm (to the extent practicable) and acknowledge
that the Preparation is administered pursuant to package insert to the
patient(s) who experience [ * ] and that [ * ] [ * ] and/or availability of
Preparation due [ * ]; and,
(d) The Preparation has not been found by [ * ] [ * ].
If these conditions are not met for the Preparation, SENJU and
ACSENTIENT shall conduct independent market research to determine product
potential and set minimum royalties based on [ * ] [ * ] of the [ ( ] or
ACSENTIENT shall have the option [ * ] [ * ]. In the event ACSENTIENT exercises
said option [ * ], ACSENTIENT's exclusive right granted by SENJU under this
License Agreement shall [ * ], and SENJU will have a right to [ * ] [ ].
In no event, will minimum annual royalties be imposed on ACSENTIENT for
the [ * ] year and [ * ] year following First Commercialization except for the
case of paragraph 4.03.
4.03 If ACSENTIENT is merged into or acquired by a third party during the
term of this License Agreement, the following minimum running royalties shall be
payable to SENJU;
(i) If ACSENTIENT is merged or acquired by Third Party on or prior
to the date of First Commercialization:
(a) For [ * ] of First Commercialization: [ * ]
(b) For [ * ] of First Commercialization: [ * ]
(c) For [ * ] of First Commercialization and subsequent
years to the termination of this License Agreement:[ * ]
(ii) If ACSENTIENT is merged or acquired by Third Party on or
during the [ * ] of First Commercialization:
(a) For [ * ] of First Commercialization: [ * ]
(b) For [ * ] of First Commercialization and subsequent
years to the termination of this License Agreement:[ * ]
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
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(iii) If ACSENTIENT is merged or acquired by Third Party on or after
the [ * ] of First Commercialization;
(a) [ * ]until termination of this License Agreement.
The minimum running royalty payments referred in this paragraph 4.03:
(i) shall be subject to the existence of the four (4) conditions for the
Preparation set forth in paragraph 4.02 above and (ii) are not cumulative. If
such condition does not exist, the amount of minimum running royalty shall be
adjusted in the manner referred in paragraph 4.02 above.
4.04 No multiple running royalty will be payable even if the Preparation,
its manufacture, use or sale, are or will be covered by more than one claim or
patent.
4.05 All of the running royalties including minimum royalties in paragraph
4.01 through 4.03 shall be paid within [ * ] following the end of ACSENTIENT's
fiscal year which commences following the First Commercialization. ACSENTIENT's
fiscal year commences January 1st of a year and ends December 31 in the same
year.
4.06 Unless otherwise expressly provided herein, no running royalty payment
to Senju under this License Agreement shall be refundable in whole or in part.
Article 5 - Payments and Records
5.01 Within [ * ] after the end of each fiscal year during the term of this
License Agreement, ACSENTIENT shall furnish SENJU with an accurate report
stating the total quantity of the Preparation in units sold by ACSENTIENT and
ACSENTIENT Agent during the preceding fiscal year, the grossed invoiced sales
price and the Net Sales thereof and amount of the royalties accrued, together
with written reports regarding marketing activities stipulated in paragraph 7.01
and 7.02 herein.
5.02 ACSENTIENT shall pay SENJU milestone payments under paragraph 3.01 and
royalties under 4.01, 4.02 and 4.03 pursuant to the applicable U.S. laws and to
the regulation of the Convention for Avoiding Double Taxation between Japan and
U.S.A. The official certificates issued by the U.S. taxation authority, which
shall be acceptable to Japanese Taxation Authority, shall evidence taxes paid in
U.S.A. SENJU shall be responsible for any withholding tax imposed on payments
made by ACSENTIENT to SENJU.
5.03 ACSENTIENT shall make and keep true and accurate records of the
production and sales of the Preparation by ACSENTIENT and ACSENTIENT Agent.
5.04 SENJU shall have the right to inspect, at its own expense, the records
prepared and kept in accordance with paragraph 5.03 above. This inspection shall
be carried out by a certified public accountant reasonably acceptable to
ACSENTIENT for the sole purpose of verifying the accuracy of ACSENTIENT running
royalty payments. This inspection shall be carried out during usual business
hours at ACSENTIENT's appropriate facility.
5.05 ACSENTIENT shall not have any obligation to keep the records kept
pursuant to paragraph 5.03 for more than [ * ] from the date of a given running
royalty payment.
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
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5.06 Any payment from ACSENTIENT to SENJU under this License Agreement shall
be remitted to the bank account designated by SENJU.
Article 6 - Development Activities and Marketing Activities
6.01 Immediately after the Effective Date and during the term of this
License Agreement, SENJU shall provide ACSENTIENT with any and all Technical
Information & Know-How in English writing in possession of or under the control
of Senju, which has not been provided to ACSENTIENT under the Secrecy Agreement
and MOU and which will become available to SENJU thereafter. Furthermore, SENJU
shall provide a listing of all documentation of Technical Information & Know-How
to be provided ACSENTIENT under this License Agreement and when specifically
requested by ACSENTIENT such documentation will be certified as being an
accurate translation of the original documentation.
6.02 ACSENTIENT shall have the right, to use any part of the Technical
information & Know-How provided by SENJU for the purpose of using the Patent
Rights, including without limitation, developing and manufacturing the
Preparation and obtaining the Governmental Approval in the Territory.
Furthermore, ACSENTIENT shall have the right to make reference to, but not to
receive a copy of the "Drug Master File" filed by SENJU or SENJU's appointed
Third Party and "New Drug Application File" filed with the USFDA by AHP to
obtain governmental approval for the manufacture and sale of the Compound and/or
for any drug containing the Compound for oral or parenteral administration, for
the purpose of obtaining the Governmental Approval in the Territory for the
Preparation.
6.03 SENJU shall supply ACSENTIENT, with necessary quantities of the
Compound for Development Activities in the Territory including pre-clinical and
clinical studies of the Preparation, [ * ]. The quantity of the Compound
supplied by SENJU to ACSENTIENT pursuant to this paragraph shall be determined
through the negotiation by both parties. Provided, however, that SENJU and
ACSENTIENT shall discuss and negotiate the conditions for supply of the Compound
including the price using for the validation of the Preparation by ACSENTIENT.
6.04 Upon the execution of this License Agreement, ACSENTIENT shall conduct,
at its own expenses and risks, the Development Activities to obtain Governmental
Approval in the Territory according to the Development Schedule. Both Parties
shall agree and acknowledge that Senju shall have no monetary obligation for
ACSENTIENT's Development Activities.
6.05 ACSENTIENT shall provide SENJU at least semi-annually with its written
report in English language concerning the status and progress of its Development
Activities in the Territory. Such written report shall include a summary of
pre-clinical and clinical data and results obtained by ACSENTIENT.
6.06 Upon obtaining of Governmental Approval, ACSENTIENT shall notify SENJU
of such effect together with a copy of a certificate of approval issued by USFDA
and use reasonable best efforts to commercialize the Preparation within [ * ]
after obtaining the Governmental Approval.
6.07 SENJU shall have a right, [ * ] to ACSENTIENT, to use or make Third
Parties outside the Territory, use, the report provided by ACSENTIENT under
paragraph 6.05 and a copy of certificate of Governmental Approval of the
Preparation to be provided by ACSENTIENT
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
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under paragraph 6.06, for the purpose of development, obtaining governmental
approval, manufacture and the commercialization of the Preparation solely
outside of the Territory. Provided, however, that if ACSENTIENT's exclusive
right granted by SENJU hereunder [ * ] [ * ] under paragraph 4.02, Senju may
[ * ] [ * ] to ACSENTIENT, the report provided by ACSENTIENT under paragraph
6.05 and a copy of certificate of Governmental Approval of the Preparation to be
provided by ACSENTIENT under paragraph 6.06 in the Territory.
Article 7 - Marketing Activities and Promotional Materials
7.01 ACSENTIENT shall and shall cause ACSENTIENT Agent to, use their
reasonable best efforts to make a minimum of [ * ] [ * ] during each of the
[ * ] following the First Commercialization.
7.02 ACSENTIENT shall spend a cumulative minimum of US$5,000,000.00 (in
addition to sales force costs) for marketing during the first three (3) years
following the First Commercialization.
7.03 ACSENTIENT shall conduct all sales, marketing and distribution of the
Preparation in the Territory. ACSENTIENT shall prepare, [ * ] appropriate
marketing, advertising and promotional material for the Preparation in the
Territory. ACSENTIENT shall furnish SENJU with those materials for SENJU's
review.
7.04 ACSENTIENT shall not, nor shall it permit ACSENTIENT Agent and
ACSENTIENT Manufacturers to submit for written or oral publication any
manuscript, abstract or the like which includes data or other information
relating to the Preparation, without first obtaining the prior written consent
of SENJU, which shall not be unreasonably withheld.
Article 8 - Exchange of Information/Reports
8.01 ACSENTIENT shall furnish SENJU with a copy of outer cartons and package
inserts of the Preparation prepared for the use in the Territory, and
thereafter, any revised version thereof together with their English translation
and explanatory notes for the revision.
8.02 From time to time during the term of this License Agreement, the
Parties shall exchange information concerning any new finding relevant to the
safety, efficacy, dosage formulation and new indications of the Preparation
(including any process improvements which related solely to the Preparation)
(hereinafter called "Improvements") when they become available to either Party.
8.03 SENJU may freely use or make any Third Party use, [ * ] Improvements
made by ACSENTIENT under paragraph 8.02 in any countries outside the Territory.
Provided, however, that if ACSENTIENT's exclusive right granted by SENJU
hereunder [ * ] [ * ] under paragraph 4.02, Senju may [ * ] [ * ] Improvements
made by ACSENTIENT. Further, SENJU may provide AHP with the Improvements
provided by ACSENTIENT under Paragraph 8.02 and AHP wishes to use such
Improvements for the purpose of obtaining the government approval and marketing
of any other preparation than ophthalmologic preparation in any country in the
world, SENJU and ACSENTIENT shall discuss the conditions, including financial
compensation for like deals, for AHP's use of the improvement.
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
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8.04 From time to time during the term of this License Agreement, Parties
shall exchange clinical and commercial information concerning the Preparation
which is deemed useful for the sale and marketing of the Preparation.
Furthermore, Party shall notify the other of any important regulatory advises or
instructions which come to either Party's attention during the term of this
License Agreement concerning quality, safety, efficacy of Compound and/or
Preparation.
Article 9 - Availability of the Compound
9.01 As soon as practicable after Effective Date, but not later than [ * ]
thereafter, SENJU shall enter into good faith negotiations with a Third Party,
which meets ACSENTIENT's approval, to conclude a supply agreement under which
said Third Party shall supply the Compound for commercial manufacture of the
Preparation in such quantities and price terms as reasonably required by
ACSENTIENT.
9.02 Within [ * ] following ACSENTIENT receipt of Governmental Approval,
SENJU shall transfer and assign the supply agreement of the Compound to
ACSENTIENT. Financial obligation under the supply agreement after the transfer
and assignment of the supply agreement from SENJU to ACSENTIENT shall be sole
responsibility of ACSENTIENT under terms of the supply agreement.
Article 10 - Adverse Event
10.01 As used in this Article the term of "Regulatory Information" shall mean
any information regarding threatened or pending action by any regulatory
authorities of the country where each party markets the Preparation, including,
but not limited to, cancellation of the approval or order to terminate sales of
its Preparation, to recall and destroy the Preparation on the market or to
revise the approved indication, dosage and administration or important caution
for use of the Preparation, or the government issue of Dear Doctor Letter
regarding the Preparation which may give serious impact to the sales of
Preparation. As used in this Article, the term of "Adverse Event" (as described
in the most current U. S. Code of Federal Regulations) shall mean any noxious,
pathological or unintended change in anatomical, physiological or metabolic
function as indicated by physical signs, symptoms occurring in clinical trials,
post-marketing surveillance, or clinical practice during the use of Preparation,
or published in the medical literature, whether or not considered casually
related to Preparation. This includes an exacerbation of a pre-existing
condition, inter-current illness, drug interaction, significant failure of
expected pharmacological or biological action. With respect to Adverse Event,
the following shall apply:
(a) As long as each Party maintains governmental approval
of the Preparation in any country of the world, ACSENTIENT and SENJU shall
report any Adverse Event known to it in respect of the Preparation or Compound
to the appropriate regulatory authorities in the countries in which it is
developing or commercializing the Preparation or Compound, in accordance with
the laws and regulations of the relevant countries and authorities, provided
that in the Territory, ACSENTIENT shall control all communications by the
Parties to the FDA, and any successor agency thereof;
(b) ACSENTIENT will submit safety data on the Preparation
in the Territory to FDA in accordance with the regulations of FDA;
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
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(c) Promptly after the Effective Date, each Party shall
appraise the other Party of the standard operating procedures for the
investigation and reporting of Adverse Event and Regulatory Information
regarding its products. The Parties shall then promptly develop and agree upon
procedures to exchange information concerning Adverse Event and Regulatory
Information of Preparation. The Parties shall immediately implement such agreed
procedures and shall provide each other on a regular basis with any appropriate
information which enables the other Party to meet its regulatory obligations
including but not limited to submission of periodic safety update report (PSUR)
in countries in which it is developing or commercializing and/or distributing
the Preparation or which is relevant to the safe use of the Preparation. The
agreed procedures will be reviewed jointly on a regular basis or when there is a
change in regulations governing Adverse Event and Regulatory Information
reporting;
(d) All Adverse Event reports and queries for SENJU
should be addressed to Director, Post Marketing Surveillance Department, SENJU
Pharmaceutical Co., Ltd., 4-9, Hiranomachi 2-chome, Chuo-ku, Osaka 541-0046,
Japan (facsimile number: 81-6-6229-3293, telephone number: 81-6-6201-9621) and
for ACSENTIENT should be addressed to Manager of Drug Safety, ACSENTIENT Inc.,
110 Doric Court, Morrisville, North Carolina 27560, U.S.A. (facsimile number:
919-460-8729, telephone number: 813-631-9551) or such other safety
representative as may be designated by SENJU for SENJU or by ACSENTIENT for
ACSENTIENT.
10.02 Each Party shall immediately notify the other of any information
received regarding any threatened or pending action by any regulatory authority,
which may affect the Compound or the Preparation or the continued manufacture,
marketing and/or distribution of the Preparation. Upon receipt of any such
information, the Parties shall consult in an effort to arrive at a mutually
acceptable procedure for taking appropriate action; provided, however, that
nothing set forth in this Paragraph 10.02 shall be construed as restricting the
right of either Party to make a timely report of such matter to any governmental
agency or take other action that it deems appropriate or required by applicable
law or regulation.
Article 11 - Confidentiality
11.01 Parties hereto undertake to keep confidential all of the information
and reports, materials, data and results of the investigation and so on
regarding the Compound and/or the Preparation which is/are received from or
provided by the other Party under this License Agreement and/or the Secrecy
Agreement and MOU, and is/are marked or otherwise indicated that the same is/are
confidential nature (hereinafter collectively called "Information" in this
Article 11), provided, however, that such Information as itemized below shall be
excluded from this confidentiality obligation;
(i) Information which was at the time of disclosure in the public
domain,
(ii) Information which after the time of disclosure became a part
of the public domain, through no fault or act of omission by the recipient
Party,
(iii) Information which was at the time of disclosure lawfully in
the recipient's possession on a non-disclosure basis,
(iv) Information received from any Third Party who has no
obligation to keep the Information confidential against any of Parties hereto,
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(v) Information which both Parties hereto agree in writing to
disclose to a Third Party or to make the same public, or
(vi) Information which is independently developed by recipient
Party without actual knowledge of the Information:
provided, further, that the recipient Party shall have competent proof
for proving the fact that the Information in question falls into the category of
either one of the items herein above.
11.02 Notwithstanding the provision of Paragraph 11.01, ACSENTIENT may
disclose the Information disclosed by SENJU to its officers, employees,
consultants or contract workers engaging in any activity for the
commercialization of the Preparation including clinical studies and other
activities for obtaining the Government Approval in the Territory, so far as the
disclosure is necessary for their performance of such activity, provided,
however, that ACSENTIENT shall take any adequate measure to cause them to keep
the information disclosed confidential under the same conditions provided in any
provision of this License Agreement.
11.03 Notwithstanding the provision of Paragraph 11.01, SENJU may, in
addition to the stipulations of paragraph 6.07 and paragraph 8.03, disclose the
Information disclosed by ACSENTIENT, to its licensees, officers, employees,
consultants or contract workers engaging in any activity for the
commercialization of the Preparation including clinical studies and other
activities for obtaining the governmental approval outside the Territory or for
obtaining patent right including any patent application and prosecution of the
patent application, so far as the disclosure is necessary for their performance
of such activity, provided, however, that SENJU shall take any adequate measure
to cause them to keep the Information disclosed confidential under the same
conditions provided in any provision of this License Agreement.
11.04 The stipulations in Article 11 will survive for [ * ] after expiration
or termination of this License Agreement.
11.05 With respect to this Article 11, other than paragraphs 11.01 and 11.03,
it is understood that AHP shall be included in the definition of SENJU in
SENJU's performing the obligations stipulated in this Article 11. SENJU
undertakes to cause AHP same confidentiality obligations as SENJU undertakes
under this License Agreement.
11.06 Notwithstanding the provision of Paragraph 11.01 and 1102, it is
understood that ACSENTIENT Manufacturer and ACSENTIENT Agent shall be included
in the definition of ACSENTIENT in ACSENTIENT's performing the obligations
stipulated in this Article 11. ACSENTIENT undertakes to cause ACSENTIENT
Manufacturer and ACSENTIENT Agent same confidentiality obligations as ACSENTIENT
undertakes under this License Agreement.
Article 12 - New Invention or Discovery
12.01 Notwithstanding the stipulation in paragraph 8.02 and 8.03 herein, in
the event that ACSENTIENT, ACSENTIENT Manufacturer, ACSENTIENT Agent, its
employees or consultant will make, conceive, reduce into practice or generate
any invention, discovery or know-how in the course or as a result of their
activities undertaken pursuant to this License Agreement, ACSENTIENT shall
notify SENJU of the invention, discovery or know-how immediately.
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
11
12.02 Upon being notified of the invention, discovery or know-how under
paragraph 12.01, SENJU shall initiate a negotiation with ACSENTIENT as to;
(i) whether or not the application for patent regarding the
invention, discovery or know-how shall be filed (if the Parties fail to agree,
ACSENTIENT shall have the right to file a patent application);
(ii) which party shall be responsible to prepare, file and
prosecute the patent application; and,
(iii) in which country such patent application shall be filed,
provided, however, that such patent application claiming the invention,
discovery or know-how recited in paragraph 12.01 shall be filed under the joint
names of SENJU and ACSENTIENT in any country or area in the world unless
otherwise agreed upon between the Parties;
12.03 Any external expense for the preparation, filing and prosecution of the
patent application to be filed under the joint names of the Parties under
paragraph 12.02 and for the maintenance of the patent rights incurred therefrom
shall equally be shared between the Parties unless otherwise agreed upon between
the Parties.
12.04 The ownership of such patent right covering the Invention, discovery or
know-how recited in paragraph 12.01 shall be equally shared between the Parties
and each Party shall have the right to use freely such invention, discovery or
know-how recited in paragraph 12.01 for any purpose. However, each Party shall
not transfer, assign, license, dispose or withdraw its share of the patent
application under paragraph 12.02 and 12.03 and the patent rights generated
therefrom without prior written consent of the other Party, and SENJU agrees not
to use such invention, discovery or know-how in the Territory. Provided,
however, that if ACSENTIENT's exclusive right granted by SENJU hereunder [ * ]
under paragraph 4.02, Senju [ * ] [ * ], such invention or discovery in the
Territory.
Article 13 - Representations and Warranties
13.01 SENJU represents and warrants the following with respect to the
Licensed Patent and Technical Information & Know-How;
(i) SENJU solely owns the entire right, title and interest or
right to license in and to the Licensed Patent and Technical Information &
Know-How;
(ii) SENJU has not granted any license or sublicense or entered
into any contract with any Third Party concerning the Licensed Patent and
Technical Information & Know-How within the Territory (except for the case where
ACSENTIENT's exclusive right granted by SENJU hereunder reverts to the
co-exclusive right under paragraph 4.02);
(iii) SENJU has not taken or failed to take any action that might
result in the invalidity or enforceability of the Licensed Patent against any
Third Party;
(iv) SENJU has no information, at the Effective Date that the
Licensed Patent and Technical Information & Know-How may be subject to challenge
or interference or be invalid or unenforceable; and
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
12
(v) SENJU has the full legal power, authority and right to enter
into this License Agreement and grant the exclusive license under the Patent
Rights and to perform its obligations under this License Agreement. Upon
execution and delivery by SENJU, this License Agreement will constitute a valid
and binding agreement of SENJU enforceable in accordance with its terms. The
execution, delivery and consummation of this License Agreement will not result
in the breach of or give rise to cause for termination of any agreement to which
SENJU may be a party which relates to the Patent Rights and Technical
Information & Know-How.
13.02 Nothing in this License Agreement or any license pursuant to it shall
be construed or implied as a representation or warranty by SENJU that the Patent
Right and Technical Information & Know-How are valid or that the
commercialization of the Preparation or any other activities of ACSENTIENT under
this License Agreement shall not be an infringement of the rights of Third Party
including, but not limited to, patent, know-how, trade-secret, trademark or
other intellectual property right of Third party.
13.03 In the event that SENJU or ACSENTIENT become aware of any actual or
threatened infringement by any Third Party upon SENJU proprietary right relating
to the Preparation, such party shall immediately notify the other Party in
writing. ACSENTIENT shall have the right to take whatever steps are necessary to
stop the infringement and recover the damages. Nothing herein obligates SENJU to
enter into litigation against such Third Party, provided in the event that
ACSENTIENT decides to enter into a litigation against such Third Party, SENJU
and ACSENTIENT shall collaborate and control over the conduct of any such action
including settlement thereof. SENJU and ACSENTIENT shall share equally the
litigation cost including the attorney's fee. However, SENJU's total liability
shall not exceed the milestone payments received from ACSENTIENT pursuant to
paragraph 3.01 herein. All proceeds resulting from the litigation pursuant to
this paragraph 13.03 shall be shared between SENJU and ACSENTIENT subject to the
Investment percentage for such litigation.
13.04 Notwithstanding paragraph 13.02, in the event of a claim or suit made
by Third Party against SENJU and/or ACSENTIENT for patent infringement involving
the manufacture, use, sale, importation, distribution or marketing of the
Preparation using the formulation including the future formulation which SENJU
uses in Japan, in the Territory, the Party sued shall promptly notify the other
Party in writing thereof.
In this case, following shall apply:
(i) ACSENTIENT shall have sole responsibility to defend such claim
or suit made by Third Party. SENJU may, at its option, to decide whether or not
SENJU is involved in the defense, provided, however, that regardless of whether
Senju decides to participate in the defense, it shall pay those litigation costs
specified in 13.04 (ii) below. SENJU shall cooperate in the defense to the
extent that SENJU shall provide any and all documents requested by ACSENTIENT to
substantiate the patent.
(ii) ACSENTIENT and Senju shall share equally the damages awarded
to, all litigation cost and attorney fees as a result of the suit or settlement
thereof. However, SENJU's total liability shall not exceed the milestone
payments received from ACSENTIENT pursuant to paragraph 3.01.
(iii) Notwithstanding paragraph 13.04 (ii), if ACSENTIENT is
obligated to pay a running royalty to the Third Party as a result of such claim
or suit made by said Third Party, SENJU and
13
ACSENTIENT shall equally share the burden of the running royalty. And the
percentage of running royalty paid by ACSENTIENT to SENJU under paragraph 4.01
herein shall be [ * ] [ * ] [ * ]. However, the running royalty to be paid from
ACSENTIENT to SENJU shall [ * ] of the Net Sales of the Preparation by
ACSENTIENT even if the running royalty to be paid from ACSENTIENT to SENJU
decreases due to the payment of running royalty to said Third Party. Upon the
termination or expiration of this License Agreement, SENJU shall be released
from any obligation to pay the running royalty to said Third Party even if
ACSENTIENT continues to commercialize the Preparation in the Territory.
13.05 In the event of a claim or suit made by Third Party against SENJU
and/or ACSENTIENT for patent infringement involving the manufacture, use, sale,
importation, distribution or marketing of the Preparation using the formulation
which ACSENTIENT develops by itself, the Party sued shall promptly notify the
other Party in writing thereof. In this case, ACSENTIENT shall settle or defend
the claim or suit under the sole responsibility of ACSENTIENT with its total
monetary obligation, and shall indemnify and hold harmless SENJU from said claim
or suit.
13.06 SENJU SHALL MAKE NO WARRANTIES WHATSOEVER, EXPRESS OR IMPLIED, WITH
RESPECT TO THE PREPARATION MANUFACTURED AND/OR SOLD HEREUNDER INCLUDING WITHOUT
LIMITATION ANY WARRANTY OF THE MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE
OF THE PREPARATION SOLD BY ACSENTIENT.
Article 14 - Indemnification
14.01 Except for SENJU's obligations to be imposed under Article 13 herein,
ACSENTIENT shall defend, indemnify and hold SENJU and AHP, their directors,
officers, shareholders, employees, consultants, contract workers and assigns
harmless from and against any lawsuit, claims, loss, damages or expenses
(including attorney's fees) arising from the Development Activities, the
manufacture, use or sale of the Preparation by ACSENTIENT, ACSENTIENT
Manufacturer or ACSENTIENT Agent.
14.02 Prior to the first administration of the Preparation manufactured by
ACSENTIENT to a human in accordance with this License Agreement, and for a
period of [ * ] after the expiration of this License Agreement or earlier
termination, ACSENTIENT shall obtain and/or maintain, at its sole cost and
expense, product liability insurance in an amount which is reasonable and
customary in the U.S. pharmaceutical industry for companies of comparable size.
Such product liability insurance shall insure against all liability, including
liability for personnel injury, physical injury and property damage.
Article 15 - Trademark
15.01 Trademark shall be selected and filed by ACSENTIENT in the name of
ACSENTIENT and at ACSENTIENT's expense, provided, however, that ACSENTIENT shall
not select and file "BRONUCK" as the Trademark for the Preparation. Upon the
registration of Trademark by USPTO (United States Patent and Trademark Office)
and at the request of SENJU, ACSENTIENT shall promptly assign ownership of the
Trademark to SENJU who will thereafter be obliged to maintain the Trademark
during the term of this License Agreement, provided that SENJU shall reimburse
to ACSENTIENT the external actual cost and fees incurred by ACSENTIENT.
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
14
15.02 If following the expiration or earlier termination of this License
Agreement, neither SENJU nor Third Party on behalf of SENJU desires to market,
sell and distribute the Preparation in the Territory, SENJU will, upon the
request of ACSENTIENT and in consideration of reimbursement to SENJU of all fees
and cost incurred by SENJU to obtain the right to the Trademark under paragraph
15.01 above, assign and transfer said Trademark to ACSENTIENT for use by
ACSENTIENT in marketing, selling and distributing of the Preparation in the
Territory.
Article 16 - Term and Termination
16.01 This License Agreement shall become effective as of the Effective Date
and shall be in full force and effect for ten (10) years after the First
Commercialization in the Territory.
16.02 Notwithstanding the stipulation of paragraph 16.01 above, either Party
may terminate this License Agreement at any time by giving notice to the other
party in the event;
(i) that either Party materially defaults or is in breach of the
performance of any material obligation imposed on it in this License Agreement
and such default is not remedied in all material aspects within [ * ] of receipt
of written demand from the notifying Party to cure the default,
(ii) that either Party assigns or makes any composition or
sequestration of its assets for the benefit of its creditors, or assigns its
rights hereunder partially or in their entirety to any Third Party without
express written consent of the other Party in breach of the stipulation in
Article 20 herein; and
(iii) that either Party becomes insolvent, goes into liquidation,
files a petition in bankruptcy, is adjudicated a bankrupt, is placed in judicial
receivership or provisional administration, or dissolves, or its financial
condition is such that it is unable to pay bills and obligations as and when due
and payable to its creditors.
16.03 If and when ACSENTIENT decides in its bona fide business judgment, to
give up its efforts to obtain Governmental Approval in the Territory and
notifies SENJU of such effect in writing, this License Agreement shall be
terminated upon receipt by SENJU of ACSENTIENT's notification thereof in
writing.
16.04 If this License Agreement is terminated by ACSENTIENT in accordance
with paragraph 16.03, ACSENTIENT shall promptly cease its Development Activity
and/or commercial activities, as the case may be, concerning the Preparation,
and, at its option, destroy the Preparation then stocked by ACSENTIENT including
the cost of the inventory, or sell the remaining inventory of the Preparation
and settle its obligation, if any, to pay any royalties or other payment due
under this License Agreement within [ * ] after the termination thereof. Upon
SENJU's request, ACSENTIENT shall return to SENJU all the Technical Information
& Know-How provided by SENJU under this License Agreement and shall assign to
SENJU, without any compensation all of the rights, titles and interests
pertaining to the Preparation including without limitation, all rights to
Government Approval in the Territory.
16.05 If this License Agreement is terminated by SENJU in accordance with
paragraph 16.02 (i), (ii) and/or (iii), ACSENTIENT shall promptly cease its
Development Activity and/or commercial activities of the Preparation, as the
case may be, and, if requested by SENJU, destroy the Preparation
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
15
then stocked by ACSENTIENT including the cost of the inventory, or, if requested
by SENJU sell the remaining inventory of the Preparation and settle its
obligation, if any, to pay any royalties or other payment due under this License
Agreement within [ * ] of ACSENTIENT's receipt of SENJU's notice of the
termination. Upon SENJU's request, ACSENTIENT shall return to SENJU all the
Technical Information & Know-How provided by SENJU under this License Agreement
and shall assign to SENJU, without any compensation all of the rights, titles
and interests pertaining to the Preparation including without limitation, all
rights to Government Approval in the Territory.
16.06 Notwithstanding anything to the contrary contained herein, in the event
of the execution by ACSENTIENT of any kind of agreement pursuant to which
ACSENTIENT would be controlled by, or be under common control with, or merge
into or consolidate with, any Third Party and ACSENTIENT loses controlling
interest in said Third Party (hereinafter called "Change of Control"), SENJU
shall have following options;
(i) to continue this License Agreement; or
(ii) to terminate this License Agreement at the end of the one (1)
year period following the Change of Control. In this case, all of the rights
granted by SENJU to ACSENTIENT under this License Agreement as well as
Governmental Approval, data and other information regarding the Preparation
provided by SENJU shall be returned to SENJU subject to SENJU's payment of the
fair and reasonable market value of such assets of the Preparation as negotiated
and agreed by the Parties. Upon such termination of this License Agreement,
ACSENTIENT will have no further obligation to make any running royalty payment
pursuant to this License Agreement.
Article 17 - Governing Laws and Arbitration
17.01 This License Agreement shall be governed by and interpreted in
accordance with the Laws of Japan.
17.02 All disputes, controversies or differences which may arise between the
Parties hereto or for the breach thereof shall be referred to and settled by
arbitration in accordance with the Arbitration Rules of the International
Chambers of Commerce as currently in force by one or more arbitrators appointed
under the Rules. Such arbitration hereunder shall be proceeded in English
language and shall be held in Japan. The determination of the arbitration shall
be final, binding and conclusive upon the Parties hereto.
Article 18 - Notice
Any notice to be given to a Party under or in connection with this License
Agreement shall be in writing and shall be (i) personally delivered, (ii)
delivered by a nationally recognized overnight courier or (iii) delivered by
certified mail, postage prepaid, return receipt requested to the Party at the
address set forth below for such Party:
* CONFIDENTIAL PORTIONS HAVE BEEN OMITTED BASED UPON A REQUEST FOR CONFIDENTIAL
TREATMENT PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934 AND
HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.
16
to SENJU: to ACSENTIENT;
Executive Vice President Chief Business Officer
SENJU Pharmaceutical Co., Ltd. AcSentient, Inc.
5-8, Hiranomachi 2-chome 110 Doric Court,
Chuo-ku, Osaka, 541-0046 Morrisville, NC 27560
Japan U.S.A.
or to such other address as to which the Party has given notice thereof.
Article 19 - Force Majeure
19.01 Neither Party hereto shall be liable for any failure to perform as
required through this License Agreement by reason of Force Majeure, to the
extent such failure to perform is due to circumstances reasonably beyond the
control of such Party, such as requisition or interference by any government,
state or local authorities, war, strikes, lockout or other labor disputes,
accidents, failure to secure required Government Approval, civil disorders or
commotions, act of aggression, acts of God, energy or other conservation
shortages, disease, or occurrences of a similar nature.
19.02 If and when any Party is hindered in its performance of its obligations
under this License Agreement by reason of Force Majeure, the performance of
those obligations shall be suspended for the duration of, but not longer than,
the continuance of such circumstances.
19.03 Either Party hereto whose performance of obligation has been hindered
by reason of Force Majeure shall inform the other Party immediately, and shall
use its reasonable best effort to overcome the effect of the Force Majeure.
Article 20 - Non-Assignability
This License Agreement is personal to the Parties hereto and shall not be
assignable to any Third Party by either Party without the prior express written
consent of the other Party, such consent not to be unreasonably withheld;
provided, however, subject to section 16.06, that no such approval shall be
required from SENJU if this License Agreement is assigned in connection with the
sale of all or substantially all of the assets or stock of ACSENTIENT, whether
by merger, acquisition or otherwise.
Article 21 - Authentic Text
This Text of this License Agreement in English language shall be the authentic
text, and any text in another language, even if such text is made by translation
of this Text of this License Agreement or prepared by any of the Parties hereto
for any purpose, shall have no meaning for any purpose between the Parties
hereto.
Article 22 - Entire Agreement
22.01 Secrecy Agreement and MOU shall be replaced by this License Agreement
as of the Effective Date so that Secrecy Agreement and MOU shall terminate
simultaneously. Notwithstanding the foregoing, the stipulations regarding
Timolol LA Ophthalmic Product in Article 10 through Article 18 in "Memorandum of
Understanding Concerning Bromfenac
17
Ophthalmic Product and Timolol LA Ophthalmic Product" dated 7th day of January
2002 between the Parties shall survive after the Effective Date of this License
Agreement.
22.02 This License Agreement shall constitute the entire agreement between
the Parties hereto concerning the subject matter hereof and shall supersede any
other agreements, whether oral or written, express or implied, and may not be
changed or modified or revised except as specifically agreed upon by the Parties
hereto in a written document bearing the respective signatures of the authorized
officers.
Article 23 - Separability
23.01 Even in the event that any portion of this License Agreement shall be
held illegal, void, ineffective or unenforceable, the remaining portion shall
remain in full force and effect.
23.02 If any of the terms or provisions of this License Agreement are in
conflict with any applicable statute or rule of law, such terms and provisions
shall be deemed inoperative to the extent that may conflict therewith and shall
be deemed to be modified to conform with such statute or rule of law.
23.03 In the event that the terms and conditions of this License Agreement
are materially altered as a result of the provision in paragraph 23.02, the
Parties will re-negotiate the terms and conditions of this License Agreement to
resolve any inequities.
IN WITNESS WHEREOF, SENJU and ACSENTIENT have caused this License Agreement to
be executed in duplicate counterparts by their duly authorized officers, each
fully executed copy hereof to be deemed as original, as of the date and year
first above written.
SENJU: ACSENTIENT:
Senju Pharmaceutical Co. Ltd. AcSentient, Inc.
signature: /s/ Shoji Yoshida signature: /s/ John T. Musante
---------------------------- ------------------------
name: Shoji Yoshida name: John T. Musante
title: President title: Chief Business Officer
18