EXHIBIT 10.43
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.
AGREEMENT
This AGREEMENT (hereinafter called this "Agreement") made and effective as of
the 17th day of April, 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, Xxxxxxxxxxx
0-xxxxx, Xxxx-xx, Xxxxx 000-0000, Xxxxx (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 000 Xxxxx Xxxxx,
Xxxxxxxxxxx, Xxxxx Xxxxxxxx 00000, X.X.X. (hereinafter called "ACSENTIENT");
WITNESSETH THAT;
WHEREAS, SENJU is developing in U.S.A. an ophthalmic product for the treatment
of glaucoma containing a chemical compound named "timolol" (hereinafter called
"Compound") as the active ingredient and is the owner of the patent covering the
technology to make a long active solution of timolol;
WHEREAS, SENJU has provided ACSENTIENT with some technical information in its
possession pertaining to Preparation under Secrecy Agreement concluded between
two Parties effective as of the 8th day of August, 2001 (hereinafter called
"Secrecy Agreement") and Memorandum of Understanding Concerning Bromfenac
Ophthalmic Product and Timolol LA Ophthalmic Product of 7th day of January, 2002
(hereinafter called "MOU") for ACSENTIENT's evaluation of the feasibility to
commercialize the Preparation in the Territory;
WHEREAS, ACSENTIENT is willing to commercialize the Preparation in the Territory
subject to the terms and conditions of this 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:
(SENJU and ACSENTIENT collectively called "Parties" and/or individually called
"Party")
Article 1 - Definitions
The following terms used in this 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. 6,335,335, 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, which is formulated and manufactured under the Patent
Rights.
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 Agreement relating to the Preparation, which is
necessary or useful for the practice of the Patent Rights, including without
limitation, 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 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 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 "Manufacturers" shall mean a manufacturer who manufactures the
Preparation on behalf of ACSENTIENT for commercialization of the Preparation in
the Territory.
1.10 "Effective Date" shall mean the date first above written on which this
Agreement shall become effective.
1.11 "Third Party" shall mean any party other than SENJU and ACSENTIENT and
Manufacturer and ACSENTIENT Agent.
1.12 "Development Activity" shall mean, SENJU's activities to perform all tests,
studies and other activities necessary to develop the Preparation and obtain
Governmental Approval of the Preparation in the Territory.
* 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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1.13 "Transfer" shall mean transfer or assignment from SENJU to ACSENTIENT
of all of the title and interest in Governmental Approval.
1.14 "Trademark" shall mean any trademark, trade dress, brand xxxx, trade
name, brand name, logo or business symbol to be used in connection with the
marketing of the Preparation in the Territory.
Article 2 - Undertaking and Scope of this Agreement
2.01 Subject to terms and conditions of this Agreement, SENJU shall, at its
own expense;
(i) conduct Development Activities;
(ii) obtain Governmental Approval and transfer or assign said
Governmental Approval to ACSENTIENT; and
(iii) execute manufacturing agreement of the commercial Preparation
with Manufacturer and transfer or assign any and all title and interest in said
manufacturing agreement to ACSENTIENT.
2.02 Subject to terms and conditions of this Agreement, ACSENTIENT shall, at
its own expense, commercialize the Preparation manufactured by Manufacturer in
the Territory after Transfer of the Governmental Approval and transfer and
assignment of all title and interest in manufacturing agreement of the
Preparation from SENJU;
Article 3 - Grant
3.01 Upon the obtaining of Governmental Approval, SENJU shall transfer and
assign any and all title and interest in the Governmental Approval to ACSENTIENT
and shall grant ACSENTIENT an exclusive license to manufacture, import, market,
promote, sell and distribute the Preparation under the Governmental Approval.
Such license shall include exclusive right to use the Patent Right and Technical
Information & Know-How to the extent that it is necessary for the sole purpose
of manufacturing, importing, marketing, promoting, selling and distributing the
ophthalmic product containing the Compound in the Territory. Provided, however,
that the license granted to ACSENTIENT by SENJU herein shall not include the
right to grant sub-license in the Territory. SENJU hereby represents that it has
full right and authority to enter into this Agreement, to grant rights provided
herein and to perform its obligations hereunder.
3.02 The license granted to ACSENTIENT by SENJU herein shall include the
right to permit Manufacturer to practice or use the Patent Right 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
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 Agreement and that it shall remain fully responsible for
the complete performance of such obligations under this Agreement.
3.03 SENJU agrees that during the term of this 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
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the Patent Rights in the Territory that would entitle any other party to market
or otherwise sell or distribute during the term of this Agreement, any product
containing the Compound for use in the Territory. The term of Subsidiary
provided in this paragraph 3.03 shall mean any legal entity fully or
substantially fully owned or controlled by SENJU.
3.04 After Transfer, 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 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 4 - Compensation
4.01 In consideration of SENJU's grant in accordance with the Article 3
hereof including Transfer of the Governmental Approval, ACSENTIENT shall, during
the term of this 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$500,000.00-
(ii) [ * ] non refundable license fee of
[ * ] [ * ]
[ * ]
(iii) [ * ] non refundable license fee of
[ * ] [ * ]
4.02 Unless otherwise provided herein, no payments to Senju under this
Agreement shall be refundable in whole or in part.
Article 5 - Royalties
5.01 In consideration of the rights granted under this Agreement, ACSENTIENT
shall pay SENJU as running royalties a sum corresponding to [ * ] of the Net
Sales of the Preparation sold in the Territory during the period following the
First Commercialization in the Territory until cumulative Net Sales reaches
[ * ] from the First Commercialization. Thereafter, ACSENTIENT shall pay SENJU
as running royalties a sum corresponding to [ * ] [ * ]of the Net Sales of the
Preparation until the expiration of the Patent Right.
5.02 Notwithstanding above paragraph 5.01, ACSENTIENT shall pay SENJU
minimum annual royalty during the [ * ] the First Commercialization. The amount
of minimum annual royalty [ * ] of the [ * ] [ * ], which is acceptable to both
Parties. Such [ * ] shall be conducted within [ * ] following the First
Commercialization.
5.03 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.
* 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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5.04 All of the running royalties including minimum royalties in paragraph
5.01 and 5.02 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.
5.05 Unless otherwise expressly provided herein, no running royalty payment
to Senju under this Agreement shall be refundable in whole or in part.
Article 6 - Payments and Records
6.01 Within [ * ] after the end of each fiscal year during the term of this
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 8.02 and 8.03
herein.
6.02 ACSENTIENT shall pay SENJU milestone payments under paragraph 4.01 and
royalties under 5.01 and 5.02 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.
6.03 ACSENTIENT shall make and keep true and accurate records of the
production and sales of the Preparation by ACSENTEINT and ACSENTIENT Agent.
6.04 SENJU shall have the right to inspect, at its own expense, the records
prepared and kept in accordance with paragraph 6.03 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.
6.05 ACSENTIENT shall not have any obligation to keep the records kept
pursuant to paragraph 6.03 for more than [ * ] from the date of a given running
royalty payment.
6.06 Any payment from ACSENTIENT to SENJU under this Agreement shall be
remitted to the bank account designated by SENJU.
Article 7 - Development Activities
7.01 SENJU shall continue to conduct its Development Activities currently on
going in the Territory and shall obtain Governmental Approval no later than
[ * ], at its own risks and expense.
7.02 SENJU shall provide ACSENTIENT at least semi-annually with its written
report in English language concerning the status and progress of its Development
Activities in the Territory.
* 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.
5
7.03 Upon the completion of its Development Activities and obtaining
Governmental Approval, SENJU shall immediately notify ACSENTIENT of such effect
and transfer any and all title and interest in Governmental Approval to
ACSENTIENT.
7.04 SENJU shall have a right, [ * ] to ACSENTIENT, to use or make Third
Parties outside the Territory use, the report generated from the Development
Activities conducted by SENJU and a copy of certificate of Governmental Approval
of the Preparation for the purpose of development, obtaining governmental
approval, manufacture and the commercialization of the Preparation solely
outside the Territory.
7.05 SENJU shall [ * ] [ * ] [ * ] in the event of the termination of this
Agreement due to the following events;
(i) SENJU decides, in its bona fide business judgement, to
discontinue Development Activities or to give up its efforts to obtain
Governmental Approval in the Territory due to the circumstance beyond the
SENJU's control and notify ACSENTIENT of such effect in writing, or
(ii) In spite of SENJU's diligence performance of Development
Activity, SENJU fails to obtain Governmental Approval until [ * ] and notifies
ACSENTIENT of such effect in writing.
Article 8 - Marketing Activities and Promotional Materials
8.01 After Transfer of the Governmental Approval from SENJU according to
paragraph 7.03, ACSENTIENT shall use reasonable effort to commercialize the
Preparation within [ * ] after Transfer. Provided, however that if ACSENTIENT
fails to commercialize said [ * ] period of term, this period of term shall be
extended for reasonable period of term through the negotiation of SENJU and
ACSENTIENT.
8.02 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.
8.03 ACSENTIENT shall spend a cumulative minimum of US$3,000,000.00 (in
addition to sales force costs) for marketing during the first three (3) years
following the First Commercialization.
8.04 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.
8.05 ACSENTIENT shall not, nor shall it permit ACSENTIENT Agent and
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.
* 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.
6
Article 9 - Exchange of Information/Reports
9.01 From time to time during the term of this Agreement, SENJU shall
provide ACSENTIENT with Technical Information & Know-How in English writing.
Such Technical Information & Know-How is in possession of or under the control
of Senju, has not been provided to ACSENTIENT under the Secrecy Agreement and
MOU, will become available to SENJU thereafter and is useful for planning a
marketing strategy of ACSENTIENT.
9.02 SENJU shall prepare level and package inserts of the Preparation taking
ACSENTIENT opinion into consideration.
9.03 From time to time during the term of this 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.
9.04 SENJU may freely use or make any Third Party use, [ * ] Improvements
made by ACSENTIENT under paragraph 9.03 in any countries outside the Territory.
ACSENTIENT may freely use, [ * ] all Improvements made or otherwise obtained by
SENJU under paragraph 9.03.
9.05 From time to time during the term of this 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 Agreement concerning
quality, safety, efficacy of Compound and/or Preparation.
Article 10 - Availability of the Preparation
10.01 Upon the execution of this Agreement, SENJU shall enter into a
negotiation with Third Party to conclude a manufacturing agreement for
commercial Preparation under which said Third Party manufactures and supplies
the Preparation to ACSENTIENT.
10.02 Upon obtaining of Governmental Approval, SENJU shall transfer and
assign any and all title and interest in the manufacturing agreement of the
Preparation to ACSENTIENT. Financial obligation under the manufacturing
agreement after the transfer and assignment of the manufacturing agreement from
SENJU to ACSENTIENT shall be sole responsibility of ACSENTIENT under terms of
the manufacturing agreement.
Article 11 - Adverse Event
11.01 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
* 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.
7
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
(including any its successor agency);
(b) ACSENTIENT will submit safety data on the Preparation in the
Territory to FDA in accordance with the regulations of FDA;
(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, Xxxxxxxxxxx 0-xxxxx, Xxxx-xx, Xxxxx 000-0000,
Xxxxx (facsimile number: 00-0-0000-0000, telephone number: 00-0-0000-0000) and
for ACSENTIENT should be addressed to Manager of Drug Safety, ACSENTIENT Inc.,
000 Xxxxx Xxxxx, Xxxxxxxxxxx, Xxxxx Xxxxxxxx 00000, X.X.X. (facsimile number:
000-000-0000, telephone number: 000-000-0000) or such other safety
representative as may be designated by SENJU for SENJU or by ACSENTIENT for
ACSENTIENT.
11.02 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 11.02 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.
8
Article 12 - Confidentiality
12.01 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 Agreement, Secrecy Agreement and/or MOU,
and is/are marked or otherwise indicated that the same is/are confidential
nature (hereinafter collectively called "Information" in this Article 12),
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,
(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.
12.02 Notwithstanding the provision of Paragraph 12.01, 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, 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
Agreement.
12.03 Notwithstanding the provision of Paragraph 12.01, SENJU may, in
addition to the stipulations of paragraph 7.04 and paragraph 9.04, 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 Agreement.
12.04 The stipulations in Article 12 will survive for [ * ] after expiration
or termination of this 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.
9
12.05 Notwithstanding the provision of Paragraph 12.01 and 12.02, it is
understood that Manufacturer and ACSENTIENT Agent shall be included in the
definition of ACSENTIENT in ACSENTIENT's performing the obligations stipulated
in this Article 12. ACSENTIENT undertakes to cause Manufacturer and ACSENTIENT
Agent same confidentiality obligations as ACSENTIENT undertakes under this
Agreement.
Article 13 - New Invention or Discovery
13.01 In the event that ACSENTIENT, Manufacturer, ACSENTIENT Agent, its
employees or consultant will solely 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 Agreement, ACSENTIENT shall notify
SENJU of the invention, discovery or know-how immediately. In the event that
SENJU including its employees, consultants or agents and ACSENTIENT,
Manufacturer, ACSENTIENT Agent including its employees or consultant will
jointly 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 Agreement, each Party shall notify the other Party
of the invention, discovery or know-how immediately.
13.02 Upon being notified of the invention, discovery or know-how under
paragraph 13.01, each Party shall initiate a negotiation with the other Party 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,
the Party who made, conceived, reduced into practice or generated any invention,
discovery or know-how 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 13.01 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;
13.03 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 13.02 (iii) and for the maintenance of the patent rights incurred
therefrom shall equally be shared between the Parties unless otherwise agreed
upon between the Parties.
13.04 The ownership of such patent right covering the invention, discovery or
know-how recited in paragraph 13.02 (iii) shall be equally shared between the
Parties and SENJU shall have the right to use or make Third Party use freely
such invention, discovery or know-how recited in paragraph 13.01 for any purpose
outside the Territory and ACSENTIENT shall have the right to use or make Third
Party use freely such invention, discovery or know-how recited in paragraph
13.01 for any purpose. However, each Party shall not transfer, assign, license,
dispose or withdraw its share of the patent application under paragraph 13.02
(iii) 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 during the term of this Agreement.
10
13.05 In the event that SENJU including its employees, consultants or agents
will make, conceive, reduce into practice or generate solely any invention,
discovery or know-how regarding the Compound, such invention, discovery or
know-how shall be sole property of SENJU. And, SENJU shall have a right to file
a patent application in relation to the invention, discovery or know-how
throughout the world under SENJU's sole name. The costs and expenses for the
preparation, filing, prosecution and maintenance of such patent application
(including the patent) shall be burdened by SENJU. Provided, however that
ACSENTIENT shall have the right to use, during the term of this Agreement, the
invention, discovery or know-how as long as ACSENTIENT manufactures and
commercializes the Preparation. SENJU shall be compensated for ACSENTIENT' use
of the invention, discovery or know-how under Article 4 and 5.
Article 14 - Representations and Warranties
14.01 SENJU represents and warrants the following with respect to the Patent
Right and Technical Information & Know-How;
(i) SENJU solely owns the entire right, title and interest or
right to license in and to the Patent Right and Technical Information &
Know-How;
(ii) SENJU has not granted, at the Effective Date, any license or
sublicense or entered into any contract with any Third Party concerning the
Patent Right and Technical Information & Know-How within the Territory;
(iii) SENJU has not taken or failed to take any action that might
result in the invalidity or enforceability of the Patent Right against any Third
Party;
(iv) SENJU has no information, at the Effective Date after its
investigation using reasonable due diligence that the Patent Right and Technical
Information & Know-How may be subject to challenge or interference or be invalid
or unenforceable; and
(v) SENJU has the full legal power, authority and right to enter
into this Agreement and grant the exclusive license under the Patent Right to
the extent that it is necessary for the sole purpose of manufacturing,
importing, marketing, promoting, selling and distributing the ophthalmic product
containing the Compound in the Territory and to perform its obligations under
this Agreement. Upon execution and delivery by SENJU, this Agreement will
constitute a valid and binding agreement of SENJU enforceable in accordance with
its terms. The execution, delivery and consummation of this 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.
14.02 Nothing in this 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 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.
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14.03 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 15 - Patent Litigation
15.01 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. SENJU 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.
15.02 Notwithstanding paragraph 14.02, 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 in the Territory using the formulation which SENJU develops under
its Development Activities and obtains Governmental Approval, the Party sued
shall promptly notify the other Party in writing thereof. In this case following
shall apply;
(i) SENJU and ACSENTIENT shall discuss how to cope with the
situation under mutual cooperation;
(ii) If either Party wishes to settle the claim or suit or to
negotiate for a patent license with Third Party, the other party may defend such
claim or suit under its sole legal responsibility including the awards and sole
responsibility of litigation cost including attorney fees. In this case, the
Party who wishes to settle the claim or suit or to negotiate for a patent
license with Third Party shall not be liable for legal responsibility including
the awards and for litigation cost and attorney fees;
(iii) Except for the litigation cost and attorney fees under
paragraph 15.02 (ii), SENJU and ACSENTIENT shall share equally the damages
awarded to, all litigation cost and attorney fees as result of the suit or
settlement. However, SENJU's total liability shall not exceed the milestone
payments received from ACSENTIENT pursuant to paragraph 4.01 until such claim or
suits made;
(iv) If Parties is obliged to pay the running royalty to the Third
Party as a result of such claim or suit made by said Third Party, SENJU and
ACSENTIENT shall equally burden such running royalty. However, the running
royalty to be paid by SENJU to said Third Party shall not [ * ] of the Net
Sales:
15.03 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.
* 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
Article 16 - Indemnification
16.01 Except for SENJU's obligations to be imposed under paragraph 15.02
herein, ACSENTIENT shall defend, indemnify and hold SENJU, its 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 the manufacture, use or sale of the
Preparation by ACSENTIENT, Manufacturer or ACSENTIENT Agent.
16.02 Prior to First Commercialization and for a period of [ * ] after the
expiration of this 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.
16.03 SENJU shall defend, indemnify and hold ACSENTIENT, its 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 Activity.
Article 17 - Trademark/Indication
17.01 Trademark shall be selected and filed by ACSENTIENT in the name of
ACSENTIENT and at ACSENTIENT's expense. 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
Agreement, provided that SENJU shall reimburse to ACSENTIENT the external actual
cost and fees incurred by ACSENTIENT.
17.02 If following the expiration or earlier termination of this 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 17.01
above, assign and transfer said Trademark to ACSENTIENT for use by ACSENTIENT in
marketing, selling and distributing of the Preparation in the Territory.
17.03 If SENJU wishes so, ACSENTIENT shall indicate "developed by SENJU
PHARMACEUTICAL CO., LTD., Japan" or its synonym on each package including eye
drop bottle, outer packages, brochure, insert leaflet, advertising and/or
promotion materials of the Preparation. Provided, however, that in the case
where the space on the surface of the eye drop bottle does not technically
permit such indication, this paragraph shall not be applicable so far as such
eye drop bottle is concerned.
Article 18 - Term and Termination
18.01 This Agreement shall become effective as of the Effective Date and
shall terminate upon the expiration of the Patent Right.
18.02 Notwithstanding the stipulation of paragraph 18.01 above, either Party
may terminate this Agreement at any time by giving notice to the other party in
the event;
* 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.
13
(i) that either Party materially defaults or is in breach of the
performance of any material obligation imposed on it in this 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
paragraph 22.01 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.
18.03 If and when SENJU notifies ACSENTIENT of discontinuance of the
Development Activities according to paragraph 7.05, this Agreement shall be
terminated upon receipt by ACSENTIENT of milestone payment returned from SENJU.
18.04 If and when ACSENTIENT decides in its bona fide business judgement, to
discontinue the commercialization of the Preparation in the Territory, this
Agreement shall be terminated, without any monetary obligations to either party,
upon receipt by SENJU of ACSENTIENT's notification thereof in writing.
18.05 If this Agreement is terminated by ACSENTIENT in accordance with
paragraph 18.04, ACSENTIENT shall promptly cease its 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 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 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 Governmental Approval in the Territory.
18.06 If this Agreement is terminated by SENJU in accordance with paragraph
18.02 (i), (ii) and/or (iii), ACSENTIENT shall promptly cease its commercial
activities of the Preparation, as the case may be, and, if requested by SENJU,
destroy the Preparation 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 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
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 Governmental Approval in the Territory.
18.07 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 after Transfer of Governmental
Approval, and ACSENTIENT loses controlling interest in said Third Party
(hereinafter called "Change of Control"), SENJU shall have following options;
* 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
(i) to continue this Agreement; or
(ii) to terminate this 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 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 Agreement, ACSENTIENT will have no further
obligation to make any running royalty payment pursuant to this Agreement.
Article 19 - Governing Laws and Arbitration
19.01 This Agreement shall be governed by and interpreted in accordance with
the Laws of Japan.
19.02 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
Xxxxxxxx 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 20 - Notice
Any notice to be given to a Party under or in connection with this 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:
to SENJU: to ACSENTIENT:
Executive Vice President Chief Business Officer
SENJU Pharmaceutical Co., Ltd. AcSentient, Inc.
5-8, Hiranomachi 2-chome 000 Xxxxx Xxxxx,
Xxxx-xx, Xxxxx, 000-0000 Xxxxxxxxxxx, XX 00000
Japan U.S.A.
or to such other address as to which the Party has given notice thereof.
Article 21 - Force Majeure
21.01 Neither Party hereto shall be liable for any failure to perform as
required through this 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 Governmental Approval, civil disorders or commotions, act of
aggression, acts of God, energy or other conservation shortages, disease, or
occurrences of a similar nature.
21.02 If and when any Party is hindered in its performance of its obligations
under this 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.
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21.03 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 22 - Non-Assignability
22.01 This 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 paragraph 18.07, that no such approval shall be
required from SENJU if this 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.
22.02 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 before Transfer of
Governmental Approval, ACSENTIENT shall immediately notice SENJU of such effect
together with intention whether or not ACSENTIENT (including continued company)
commercializes the Preparation. If ACSENTIENT (including continued company)
intents not to commercialize the Preparation, this Agreement shall terminate,
without any monetary obligation to either party, upon SENJU's receipt of such
ACSENTIENT's intention.
Article 23 - Authentic Text
This Text of this 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 Agreement or prepared by any of the Parties hereto for any purpose,
shall have no meaning for any purpose between the Parties hereto.
Article 24 - Entire Agreement
24.01 Secrecy Agreement and Article 10 through Article 18 of MOU shall be
replaced completely by this Agreement as of the Effective Date so that MOU shall
terminate simultaneously.
24.02 This 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 25 - Separability
25.01 Even in the event that any portion of this Agreement shall be held
illegal, void, ineffective or unenforceable, the remaining portion shall remain
in full force and effect.
25.02 If any of the terms or provisions of this 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.
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25.03 in the event that the terms and conditions of this Agreement are
materially altered as a result of the provision in paragraph 25.02, the Parties
will re-negotiate the terms and conditions of this Agreement to resolve any
inequities.
IN WITNESS WHEREOF, SENJU and ACSENTIENT have caused this 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/ Xxxxx Xxxxxxx signature: /s/ Xxxx X. Xxxxxxx
---------------------------- --------------------
name: Xxxxx Xxxxxxx name: Xxxx X. Xxxxxxx
title: President title: Chief Business Officer
17
