EXHIBIT 10.5
CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTION.
AGREEMENT FOR
MANUFACTURING AND SUPPLY OF BNP7787
Made as of April 12, 2001 (the "Effective Date")
by and between
BIONUMERIK PHARMACEUTICALS, INC.,
(hereinafter referred to as "BioNumerik"),
a corporation duly organized and validly
existing under the laws of the State of
Texas with its principal offices at Suite
1250, 0000 Xxxxxxxxx Xxxxx,
XXX XXXXXXX, XX 00000, XXX
and
SUMIKA FINE CHEMICALS CO., LTD.
(hereinafter referred to as "Sumika"),
a corporation duly organized and validly existing under the laws of Japan,
with its principal offices at 1-21, Utajima 3-chome, Xxxxxxxxxxxxx-xx,
Xxxxx 000-0000, Xxxxx
1 DEFINITIONS
Unless otherwise expressly set forth herein, the following
terms shall have the meanings set forth below:
1.1 Calendar Quarter
Shall mean each three (3) month period ending on March 31,
June 30, September 30 or December 31.
1.2 Compound
Shall mean the compound 2,2'-Dithio-Bis-Ethane sulfonate,
disodium salt, also known as BNP7787.
1.3 Confidential Information
Shall mean all information, whether technical or
non-technical, trade secrets, discoveries, data, drawings,
techniques, documents, models, samples and know-how, whether
or not patented or patentable, owned or possessed by the
Parties on the date of this Agreement or later developed by
them.
1.4 Party
Shall mean BioNumerik or Sumika, and when used in the plural
form both BioNumerik and Sumika.
[**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTION.
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1.5 Product(s) or Finished Dosage Form
Shall mean any pharmaceutical composition containing the
Compound as the pharmacologically active ingredient.
1.6 Specifications
Shall mean the mutually agreed upon specifications for the
Compound attached on Annex 1 hereto.
2 MANUFACTURE AND SUPPLY OF COMPOUND
2.1 Subject to the provisions of this Agreement, BioNumerik shall
purchase from Sumika and Sumika shall supply, at the price set
forth in Annex 2 attached hereto, a minimum of [**] of
BioNumerik's annual actual requirements of the Compound until
the cumulative total amount of the Compound purchased by
BioNumerik from Sumika reaches [**]. BioNumerik may also
consider additional procurements of its Compound from other
manufacturers in accordance with Section 2.3.
2.2 The Compound shall be manufactured and delivered in accordance
with the Compound Specifications indicated in Annex 1, which
will be mutually updated from time to time by the Parties. In
addition, manufacturing of the Compound by Sumika will be
conducted in compliance with current U.S. FDA Good
Manufacturing Practices (cGMP), ISO9002 and International
Conference on Harmonization (ICH) regulations and guidelines.
BioNumerik shall not export the Compound sold by Sumika
hereunder or the Product(s) produced from such Compound to any
country or territory where such export would be in violation
of the patent laws of such territory. Prior to any export of
Compound(s) or Product(s), BioNumerik and Sumika shall, if
requested by either party, discuss in good faith the matter of
whether such export would violate the patent laws of the
intended country or territory of export. In addition to the
foregoing, BioNumerik shall have no obligation to purchase
from Sumika any percentage of its requirements of Compound
with respect to a territory to which it is unable to export
Compound as provided in the Section 2.2 or to which Sumika
does not agree to export Compound as provided in Section 2.9.
Sumika will not sell the Compound to any party other than
BioNumerik without BioNumerik's prior written consent.
Sumika shall be entitled to appoint any trading company it
deems appropriate to act as an intermediary between the
Parties for the purchase, sale and delivery of the Compound,
provided that the costs paid or payable by BioNumerik shall
not increase because of such appointment and such trading
company shall be reasonably acceptable to BioNumerik.
[**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
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2.3 In the event BioNumerik considers procurements of its Compound
in addition to the amount (a minimum of [**] of BioNumerik's
annual actual requirements of the Compound until the
cumulative total amount of the Compound purchased by
BioNumerik from Sumika reaches [**] to be purchased pursuant
to Section 2.1, BioNumerik may conduct such additional
procurements from other manufacturers, provided BioNumerik
shall give Sumika notice of such consideration prior to any
farther contracting with another supplier or suppliers for
such additional Compound amounts. In such circumstances,
Sumika may, a its option, provide BioNumerik with a bid
containing new price, delivery amount and other material terms
under which it would manufacture and transport Compound on a
non-exclusive basis to BioNumerik. It is the hope of the
Parties that Sumika will manufacture A significant and major
portion of the Compound to be supplied to BioNumerik, subject
to meeting the competitive requirements of price, quality,
supply, delivery and other material terms relative to other
potential or active manufacturers. If such bid from Sumika is
on substantially competitive terms with BioNumerik's other
alternatives for manufacturing Compound, then BioNumerik and
Sumika will negotiate in good faith to enter into an amendment
to this Agreement providing for the manufacture by Sumika of a
significant portion of the Compound amounts required by
BioNumerik, which portion will be determined by BioNumerik in
its discretion based on BioNumerik's evaluation of
considerations including the need to manage risk by having
more than one manufacturer of Compound. In the event of any
unsuccessful bid by Sumika, BioNumerik will describe to Sumika
the categories in which its bid was deemed not competitive. In
the absence of any bid from Sumika (within 60 days of receipt
of the notice from BioNumerik) to manufacture Compound on
substantially competitive terms to BioNumerik's other bid,
BioNumerik shall be free to utilize such other alternatives
for the manufacture of manufacturing alternatives Compound.
Until an amendment to this Agreement is entered into by the
Parties, Sumika's obligations shall continue to manufacture
and supply Compound as provided in this Agreement. The Parties
recognize that Sumika shall have reasonable opportunities to
be a significant manufacturer of Compound as provided above,
but that no assurance can be given that Sumika will be a sole
source for the Compound due to the expected volume of use,
taxation/importation costs that may be encountered in various
territories, and other considerations.
2.4 BioNumerik and Sumika will regularly communicate concerning
the purchase and sale of the Compound. BioNumerik shall
provide to Sumika, no later than the 15th day following the
end of each Calendar Quarter, a forecast of its estimated
purchase orders from Sumika for the 12 calendar months
following the month in which the forecast is transmitted.
BioNumerik may make more frequent forecasts as it may deem
necessary. Except as otherwise provided herein, the terms and
conditions of all sales of the Compound by Sumika to
BioNumerik shall be in accordance with an acknowledgement
("Acknowledgement") provided by Sumika to BioNumerik in
response to each purchase order placed by BioNumerik
hereunder. The quantity of each shipment of the Compound
specified in each Acknowledgement shall be definitive for all
purposes herein absent conclusive error. BioNumerik shall
provide Sumika with purchase order(s) for Compound at least
[**] prior to the time BioNumerik requires such Compound.
Each minimum purchase order amount of the Compound by
BioNumerik shall be [**]. During the term of this Agreement,
Sumika shall provide BioNumerik with such quantities of
Compound as may be requested by BioNumerik and accepted by
Sumika in accordance with the terms of this Agreement.
2.5 BioNumerik shall test and approve the quality of delivered
Compound within 21 days after receipt of the Compound. If
BioNumerik fails to so test or approve, BioNumerik shall be
deemed to have tested and approved the quality of such
Compound. If BioNumerik informs Sumika within the said 21
days' period that the delivered Compound does not meet the
Specifications, BioNumerik shall, within 10 days thereafter,
send back the non-conforming Compound, and disclose the test
results concerning such Compound, to Sumika. Then, the Parties
shall cooperate with each other in promptly examining such
test results and promptly comparing the non-conforming
Compound in question and the sample of the Compound retained
by Sumika. If the Compound proves to be non-conforming at the
time of delivery to BioNumerik, upon BioNumerik's written
request, Sumika will promptly send to BioNumerik without
additional charge replacement amounts of the ordered Compound
that were non-conforming, and provide BioNumerik with a credit
equal to the transportation costs of such non-conforming
Compound. Sumika's foregoing obligations shall be the sole
remedy to BioNumerik Sumika's total responsibility shall not
[**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTION.
exceed the value of the Compound in question plus related
shipping costs. Prior to approval of the Compound for
commercial sale, BioNumerik shall warehouse any back-up supply
of Compound purchased by BioNumerik from Sumika. If the
Parties discuss and agree that Sumika will hold such inventory
on behalf of BioNumerik, then Sumika shall send BioNumerik lot
sample(s) of the Compound and then BioNumerik shall test and
approve the quality of such sample(s) within 21 days of
receipt thereof and shall thereafter make the payment for such
Compound within 30 days; provided, however, that if the
quality of the Compound has been approved in advance by
BioNumerik, then BioNumerik shall make the payment within 30
days after BioNumerik's order therefor with Sumika. Such
Compound shall be subject to the product warranties set forth
in Article 4 of this Agreement.
2.6 The price of the Compound shall be on a [**] and in accordance
with Annex 2 attached hereto. In the event that BioNumerik
requests for the delivery of the Compound on other trade
terms, any increase of transportation and other costs incurred
by such request shall be borne by BioNumerik. Payment for all
Compound purchased from Sumika by BioNumerik in accordance
with this Agreement and approved by BioNumerik in accordance
with Section 2.5 shall be made in full within 30 days after
Compound satisfying the required Specifications are received.
BioNumerik shall make such payment without set-off,
counterclaim, or other such rights which BioNumerik may claim
against Sumika. Overdue payments shall accumulate interest
thereon at the rate of 14 percent per annum. Payment by
BioNumerik hereunder shall be made by wire transfer in
accordance with Annex 3.
2.7 As a part of this Agreement, Sumika shall maintain all of the
appropriate Specifications and standard operating procedures
related to the manufacturing of the Compound. These will be
treated as controlled documents and will be maintained
utilizing a suitable document control procedure to ensure
proper issuance and change, respectively. During the term of
this Agreement and for a period of at least two years
thereafter, Sumika shall maintain records of inspection and
testing, lab notebooks and procedures made in connection with
the manufacturing work conducted under this Agreement. In
addition, as a part of this Agreement Sumika shall prepare and
maintain an updated Drug Master FIle (DMF) for the Compound
for the United States, the European Union, and Japan and shall
answer any deficiency letter that the U.S. FDA and/or other
relevant regulatory health authority may issue to BioNumerik
regarding the manufacturing process for the Compound, provided
that the Parties shall discuss and agree in writing upon the
costs and expenses required for the preparation of such DMF.
The costs to prepare a DMF are estimated to consist of
approximately [**] for document compilation of analytical
matters; [**] for document compilation of CMC matters; and
[**] for finishing the DMF compilation and preparation; and in
any event the total DMF cost shall not exceed [**].
[**] Certain INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTION.
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2.8 Sumika shall keep BioNumerik regularly informed of the status
and progress of the manufacturing of Compound through regular
telephone or e-mail updates and through written summaries
provided to BioNumerik on a quarterly basis. Sumika recognizes
and agrees that any change in the process for preparation or
manufacture of the Compound (whether planned or unplanned)
must be approved in advance in writing by BioNumerik.
2.9 Subject to the limitations on exports contained in Section 2.2
hereof, Sumika shall be responsible for complying with all
transport regulations and export laws applicable under the
laws of Japan and any export territory agreed upon by the
Parties concerning the provision of the Compound to BioNumerik
in accordance with this Agreement. BioNumerik shall be
responsible for complying with all transport regulations and
export laws applicable under the federal, state and local laws
of the United States of America and other territories
designated by the Parties concerning the Compound. Sumika will
use reasonable best efforts to assure that the Compound will
be transported to BioNumerik in a reasonable and appropriate
manner, which will include reasonable consideration of
environmental conditions of the shipping, cGMP requirements,
and the procedures and precautions to be followed by the
shipper.
3 INSPECTIONS AND CONTROLS
3.1 Subject to confidentiality obligations contained in Section 7,
Sumika agrees to allow inspections of its manufacturing
facilities in which the Compound is being manufactured,
analyzed or tested, by representatives of BioNumerik or Grelan
Pharmaceutical Co., Ltd. ("Grelan"), as well as FDA and other
material regulatory authorities of the U.S. or other
governments, during normal working hours upon prior written
notice to Sumika. Sumika shall grant access to such premises
and to the documentation necessary for or appropriate to the
manufacturing and quality control of the Compound. BioNumerik
shall cause Grelan to comply with the Confidentiality
obligations set forth in this Agreement and shall be
responsible for any breach of such obligations by Grelan.
3.2 Sumika shall ensure all manufacturing, test and inspection
equipment is maintained under a documented calibration program
that is ISO9002 and ICH compliant. This includes providing
equipment calibration certifications as required.
3.3 Sumika will maintain environmental controls, including
particulate and bioburden monitoring, pest controls and
housekeeping procedures in accordance with FDA cGMP, ISO9002
and ICH regulations and guidelines. The use of supplies of
process water, air and particulate handling, etc., for cGMP
manufacture of the Compound, shall be consistent with FDA cGMP
specifications and ICH regulations and guidelines.
3.4 Sumika shall maintain a Quality Control department, which is a
distinct department separate from manufacturing. Sumika
Quality Control/Quality Assurance will perform incoming,
in-process and finished product inspections, review records,
perform line clearances, maintain batch history records,
provide batch history records for review and accuracy and
completeness and provide product release services in
accordance with cGMP and ICH regulations and guidelines.
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3.5 Sumika will promptly notify BioNumerik of any FDA or other
material regulatory inspection of Sumika related to the
Compound, and will promptly provide BioNumerik with a copy of
documentation and Sumika's correspondence and plans to address
any deficiencies relating to such inspection.
4 PRODUCT WARRANTIES
4.1 Sumika warrants and represents exclusively to BioNumerik that
the Compound manufactured by Sumika and delivered to
BioNumerik hereunder shall, at the time of shipment, conform
to the Specifications and be manufactured in accordance with
all applicable laws and regulations relating to the
manufacture of the Compound, including but not limited to,
applicable supranational, national and local laws in the
country when and where manufacture occurs, current U. S. FDA
Good Manufacturing Practices (cGMP), ISO9002 and ICH
regulations and guidelines. Sumika further represents that the
API is still in a development process and that the shelf life
stability of API will be determined based on additional
stability testing data that is obtained in the future. EXCEPT
AS EXPRESSLY SET FORTH IN THIS AGREEMENT, SUMIKA MAKES NO
REPRESENTATIONS OR WARRANTIES WHATSOEVER, EXPRESS OR IMPLIED,
INCLUDING BUT NOT LIMITED TO, ANY WARRANTY OF MERCHANTABILITY
OR FITNESS FOR ANY INTENDED USE OR PURPOSE. Notwithstanding
the foregoing, BioNumerik shall have no obligation to purchase
any Compound that does not meet the Specifications as provided
in Section 2.5 hereof.
5 DEBARMENT CERTIFICATION
5.1 Sumika warrants that it will not knowingly use in connection
with the services rendered under this Agreement in any
capacity the services of any person debarred under the U.S.
Food, Drug & Cosmetic Act or any other similar law or
regulation governing drug manufacturing.
6 INDEPENDENT CONTRACTOR STATUS
6.1 Each of the Parties in performing this Agreement shall be and
be deemed to be acting as an independent contractor and not as
the agent or employee of the other. Accordingly, BioNumerik
shall purchase the Compound from Sumika, which Sumika has
manufactured in accordance with the Specifications. BioNumerik
and/or its designated affiliates or agents shall then
manufacture the Finished Dosage Form in accordance with
BioNumerik's specification therefor. Neither Sumika nor
BioNumerik shall have any authority whatsoever to act as agent
or representative of the other Party nor any authority or
power to contract or create any obligation or liability on
behalf of the other Party or otherwise bind any other Party in
any way for any purpose.
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7 CONFIDENTIALITY
7.1 Each Party shall hold all Confidential Information received
from the other Party in strictest confidence and shall use the
same level of care to prevent any unauthorized use or
disclosure of such Confidential Information as it exercises in
protecting its own information of similar nature. The Parties
shall not disclose any Confidential Information received from
the other Party to any third party without the prior written
consent of the other Party.
7.2 The Confidential Information shall be supplied to the Parties
in written form and shall be identified as being confidential
and disclosed under the provisions of this Agreement. Any
information that is disclosed in oral form shall be confirmed
in writing within sixty (60) days after disclosure and be
deemed included as Confidential Information within the scope
of this Agreement.
7.3 Each Party shall have the right to disclose the Confidential
Information of the other Party to the minimum number of those
officers and employees who need to know it for the purposes of
this Agreement. Such disclosure is allowed only on condition
that the persons to whom the Confidential Information will be
disclosed shall be, by law, contract or other undertaking,
under confidentiality obligations corresponding to those set
out in this Agreement.
7.4 The disclosing Party retains all rights to its Confidential
Information.
7.5 The confidentiality obligations of this Agreement shall not
apply to:
a) Confidential Information which at the time of the
disclosure is in the public domain; or
b) Confidential Information which, after disclosure,
becomes part of the public domain otherwise than by
breach of this Agreement; or
c) Confidential Information which can be established by
reasonable and competent proof to have already been
in the receiving Party's possession prior to
disclosure and was not acquired, directly or
indirectly, from the disclosing Party; or
d) Confidential Information which a receiving Party
shall receive from a third party who has the legal
right to disclose it and who would by disclosure not
breach, directly or indirectly, any confidentiality
obligation to either Party; or
e) Confidential Information which is released for
disclosure by prior written consent of the disclosing
Party; or
f) Confidential Information which has been independently
developed by a Party hereto without the use or
benefit of Confidential Information received from the
other Party; or Confidential Information which is
required to be disclosed by law or by order of court
of competent jurisdiction, provided that due advance
notice is given to the other Party of such a
requirement and also such disclosure is then made
only to the minimum extent so required.
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7.6 The burden of proving that any of the above exceptions is
applicable to a Party to relieve it of its liability or
obligations hereunder shall be upon the Party claiming such
exception(s).
7.7 Grelan shall comply with the confidentiality obligations set
forth herein as if Grelan is a party to this Agreement.
8 INTELLECTUAL PROPERTY RIGHTS
8.1 a) As used herein "Intellectual Work Product" means all
inventions, modifications, discoveries, improvements,
processes, techniques, documentation, scientific and
technical data, drawings and other information other
than the Sumika Technology, that is generated as a
result of the manufacturing services performed for
BioNumerik by Sumika in accordance with this
Agreement. "Sumika Technology" means all present and
future documentation, scientific and technical data,
processes, test procedures, information, know-how,
techniques, technology, patents, patent rights,
copyrights, trade secret rights, inventions,
intellectual property rights, and other information
and techniques that are owned, developed or licensed
by Sumika (other than those developed hereunder or in
connection with the manufacturing or other projects
performed for BioNumerik by Sumika). BioNumerik shall
not own any of the Sumika Technology. However, Sumika
shall use the Sumika Technology, as far as it is
applicable, in order to efficiently carry out the
manufacture of the Compound.
b) The Parties hereto understand and agree that no
rights are being conveyed to Sumika (or any of their
affiliates) to use any BioNumerik Technology (as
hereafter defined) for any purpose other than the
sole purpose of preparing the Compound for the
benefit of BioNumerik in accordance with the terms of
this Agreement. As used herein, "BioNumerik
Technology" means all present and future
documentation, scientific and technical data,
processes, test procedures, information, know-how,
techniques, technology, patents, patent rights,
copyrights, trade secret rights, inventions,
intellectual property rights, and other information
and techniques that are owned, developed, or licensed
by BioNumerik. Prior to and during the course of
developing this Agreement, and in the future during
the course of this Agreement, BioNumerik has provided
and may provide Sumika with confidential and
proprietary enabling disclosures pertaining to the
composition, processes and conditions for
manufacturing, potential uses and other commercially
sensitive information relating to the Compound.
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8.2 a) Sumika acknowledges that BioNumerik is the sole and
exclusive owner of all Intellectual Work Product
(except the Sumika Technology, as described above in
8.1). In consideration of the covenants contained
herein, and for other good and valuable consideration
set forth herewith, Sumika hereby assigns and
transfers to BioNumerik and its successors and
assigns all right, title and interest that Sumika has
or may later acquire in and to the Intellectual Work
Product under copyright, patent, trade secret and
trademark law. Such assignment includes the
assignment of the entire right, title and interest in
and to all applications for letters patent and any
and all letters patent or patents in the United
States of America and all foreign countries which may
be granted on and in connection with the Intellectual
Work Product.
b) Sumika agrees to co-operate with BioNumerik so that
BioNumerik may enjoy to the fullest extent the entire
right, title and interest in and to the Intellectual
Work Product. In connection therewith, Sumika agrees
to execute, if necessary, additional papers and
documents and to take all actions requested by
BioNumerik in order to (a) further evidence ownership
of the Intellectual Work Product by BioNumerik and
its successors and assigns and (b) allow BioNumerik
to procure, maintain and enforce all letters patent
and intellectual property rights to the Intellectual
Work Product. BioNumerik agrees to reimburse Sumika
all reasonable costs in relation to the production of
additional papers and documents as well as all
actions requested by BioNumerik pursuant to this
Section 8.2(b).
c) In addition, in the event the manufacturing efforts
hereunder result in a synthesis or manufacturing
process for the Compound that incorporates Sumika
Technology, BioNumerik shall be granted, and is
hereby granted, a worldwide, personal, non-exclusive,
perpetual, royalty-free, non-sublicensable license to
practice said inventions and technology to the extent
they relate to such synthesis and manufacturing (so
long as such grant is not in violation of Sumika's
agreements with other parties existing as of the date
of this Agreement). BioNumerik will not transfer the
Sumika Technology to any third party without the
prior written agreement of Sumika, and no third party
may use the Sumika Technology without the prior
written agreement of Sumika.
d) [**].
8.3 Except for use for the purposes as defined in this Agreement,
no right, title, interest, or license in or to any trademark,
patent, copyright or service xxxx or symbol or any other
intellectual property right of a Party is granted to the other
Party under this Agreement.
9 INDEMNIFICATION PROVISIONS
[**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTION.
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a. Sumika shall not be responsible for any product
liability relating to or arising from any Compound
supplied by Sumika under this Agreement and the
Product(s) produced from such Compound so long as the
Compound and the production method of such Compound
have been approved by BioNumerik, unless such
approval is based on inappropriate data provided by
Sumika.
9.1 BioNumerik will indemnify and hold harmless Sumika, its
affiliates, any present or future parent or subsidiary of
them, and their respective officers, directors, employees,
counsel, agents and affiliates (the "Indemnified Sumika
Parties") against any and all losses, liabilities, damages,
costs and expenses including, but not limited to, reasonable
attorney fees and any and all reasonable expenses incurred in
defending against any litigation, commenced or threatened, or
any claim, and any and all amounts reasonably paid in
settlement of any claim or litigation commenced or threatened
("Losses"), arising out of (i) product liability, patent and
trademark infringement or other suits and claims relating to
rights under BioNumerik's control and regarding any active
pharmaceutical ingredient or raw materials, including but not
limited to, any bulk drug, or the Compound, Products or
Finished Dosage Form, including but not limited to the
sterilization, bottling or production processes thereof, (ii)
any failure by BioNumerik to comply with any applicable
governmental regulation (including, without limitation, any
applicable environmental laws), (iii) any breach of any
representation, warranty, covenant or agreement of BioNumerik
contained in this Agreement, (iv) the use by Sumika of any raw
or component material(s) supplied by BioNumerik to Sumika or
by a third party on BioNumerik's behalf, or (v) the promotion,
marketing, distribution and sale, whether directly or through
distributors, of the Compound; PROVIDED, HOWEVER, THAT
BIONUMERIK SHALL NOT INDEMNIFY OR HOLD HARMLESS ANY OF THE
INDEMNIFIED SUMIKA PARTIES TO THE EXTENT THAT SUMIKA OR ANY
INDEMNIFIED SUMIKA PARTIES ARE RESPONSBILE BY NEGLIGENCE OR
WILLFUL ACT FOR SUCH LOSSES, LIABILITIES, DAMAGES, COSTS AND
EXPENSES.
9.2 Sumika will indemnify and hold harmless BioNumerik, its
affiliates, any present or future parent or subsidiary of any
of them, and their respective officers, directors, employees,
counsel, agents and affiliates (the "Indemnified BioNumerik
Parties") against any and all Losses arising out of (i) any
breach of any representation, warranty, covenant or agreement
of Sumika contained in this Agreement, or (ii) any failure by
Sumika to comply with any applicable governmental regulation
(including, without limitation, any applicable environmental
laws), BUT ONLY TO THE EXTENT SUCH FAILURE REFERRED TO WITHIN
(ii) OF THIS PARAGRAPH IS ATTRIBUTABLE TO SUMIKA'S BREACH OF
THIS AGREEMENT, OR SUMIKA'S FAILURE TO MANUFACTURE ANY PRODUCT
IN CONFORMANCE WITH THE SPECIFICATIONS; provided further that
Sumika will not indemnify and hold harmless Indemnified
BioNumerik Parties for any losses arising out of BioNumerik's
negligence or willful act.
9.3 Conditions of Indemnification: With respect to any
indemnification obligations of either Party to the other Party
under this Agreement, the following conditions must be met for
such indemnification obligations to become applicable:
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a) The indemnified Party shall notify the indemnifying
Party promptly in writing of any claim which may give
rise to an obligation on the part of the indemnifying
Party hereunder;
b) The indemnifying Party shall be allowed to timely
undertake the sole control of the defense of any such
action and claim, including all negotiations for the
settlement, or compromise of such claim or action at
its sole expense;
c) The indemnified Party shall at its sole expense
render reasonable assistance, information,
co-operation and authority to permit the indemnifying
Party to defend such action.
9.5 BioNumerik shall notify Sumika in writing of any defect that
it learns of, which is likely to affect the manufacture of the
Compound as contemplated by this Agreement.
10 TERM AND TERMINATION
10.1 This Agreement shall enter into force as of the Effective Date
of the Agreement and unless earlier terminated, shall continue
in full force and effect until BioNumerik's fulfilling and
completing its obligations set forth in Section 2.1 unless
extended by agreement of the Parties. Sections 4, 7, 8, 9, 11,
16 and 17 shall survive any termination of this Agreement.
10.2 The Parties may terminate this Agreement upon mutual written
agreement at any time during the Term of this Agreement.
10.3 Either party may terminate this Agreement without penalty at
any time without payment of any compensation by giving six
months prior written notice of termination to the other party,
if either party believes that such termination is reasonably
justified, provided that, if requested by the non-terminating
party, the terminating party shall discuss such termination
with the other party for a period of up to 60 days in a good
faith and best effort to find a mutually agreeable solution
for avoiding such termination. If the circumstances require
more than 60 days to adequately discuss such matter, the 60
days discussion period set forth in the preceding sentence
will be extended to up to 180 days (inclusive of the 60 day
discussion period described above) at the request of either
party. In the event that both parties fail to find a mutually
agreeable solution for avoiding such termination in such a
period of 60 days or 180 days as stipulated above, this
Agreement shall be terminated, provided however that ,
notwithstanding the provisions of Section 10.1, (i) any rights
and obligations of each party under this Agreement except
those stipulated in clauses (ii) and (iii) of this sentence
set forth below shall lose effect on the date of such
termination, (ii) the Parties shall be responsible for
fulfilling and completing all orders for Compound made by
BioNumerik prior to the date of such termination, and (iii)
Sections 4, 7, 8, 9, 11, 16, and 17 shall survive any such
termination.
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Either Party shall have the right, without prejudice to any
other rights or remedies available to it, to terminate this
Agreement for cause with immediate effect by written notice to
the other Party in any of the following events:
a) The other Party defaults in the performance of any of
its obligations under this Agreement and such default
continues unremedied for thirty (30) days from notice
to the defaulting Party;
b) The other Party intentionally makes (or is discovered
to have intentionally made) any material false
representations or omissions, reports or claims in
connection with the business relationships of the
Parties;
c) Any of the representatives of the Parties engages in
(or is discovered to have engaged in) fraudulent,
criminal or negligent conduct in connection with the
business relationships of the Parties;
d) The other Party files a petition in bankruptcy, is
adjudicated bankrupt, files for reorganization, is
placed in liquidation, makes a general assignment for
the benefit of its creditors, becomes insolvent or is
otherwise unable to fulfill its business obligations;
e) Any change occurs with respect to the ownership of
the other Party by virtue of dissolution,
reorganization or transfer or sale of fifty percent
(50 %) or more of the outstanding stocks of the other
Party to a third party having activities within the
pharmaceutical field.
11 LIMITATION OF DAMAGES
11.1 In no event shall either Party be liable to the other Party or
third parties for any indirect, incidental or consequential
damages, such as e.g. lost profits in connection with its
performance under this Agreement or any breach thereof. The
restrictions of liability to compensate damages stipulated for
in this article shall not be applied to any breach of the
intellectual property rights of Sumika or BioNumerik or its
principals, including but not limited to rights of patent,
copyright and trademark or unauthorized disclosure of the
trade secrets or other confidential information of the same
provided to either of the Parties under this Agreement. The
compensation for damages for such breach shall include any
damages suffered by Sumika or BioNumerik, whether direct or
indirect, including but not limited to damages suffered due to
loss of profits, business or good-will, provided that the
amount of such compensation shall not exceed the value of the
Compound sold and purchased between the Parties under this
Agreement.
12 FORCE MAJEURE
12.1 Neither Party shall be liable for delays or failure of performance of any
obligation hereunder by reason of an Act of God, fire, flood, earthquake,
war, public disaster, strike or labor difference, governmental enactment,
rule or regulation, unforeseeable raw material shortages, transportation
interruption or any other cause beyond such Party's control, provided that
diligent continuing efforts are made to resume performance if such
resumption is a commercially reasonable option. Written notice must be
given to the other Party for any claim made under this clause.
13 PUBLICITY AND PUBLICATIONS
13.1 Except as provided by this Agreement or as required by law,
neither Party shall originate any publicity, news release or
other public announcement, written or oral, whether to the
public press, or otherwise, relating to this Agreement, any
amendment hereto or performance hereunder, or the existence of
any arrangement between the Parties without the prior written
approval of the other Party, which approval shall not be
unreasonably withheld.
14 AUTHORIZATION AND NOTICES
14.1 All notices referred to herein shall be sent by prepaid
registered mail or by telefax and shall be deemed delivered if
sent to the addresses of the respective Parties hereinbelow
indicated, or such other address as is furnished by such
notice to other Party.
Notices and payments to Sumika shall be made to:
SUMIKA FINE CHEMICALS CO., LTD.
1-21, Utajima 3-chome
Xxxxxxxxxxxxx-xx, Xxxxx 000-0000, Xxxxx
Attn: Mr. Katsuyki Imada, Assistant Manager,
International Business Division
Dr. Naruhito Masai, Director International Business
Division
Fax: x00-0-0000-0000
Phone: x00-0-0000-0000
e-mail : xxxxx@xxxxxx-xxxx-xxxx.xx.xx
xxxxx@xxxxxx-xxxx-xxxx.xx.xx
Notices and invoices to BioNumerik shall be made to:
BIONUMERIK PHARMACEUTICALS, INC.
Suite 1250,
0000 Xxxxxxxxx Xxxxx,
Xxx Xxxxxxx, Xx 00000, XXX
Attn: Xx. Xxxxx Xxxxxx, Project Manager
Fax: x0 000 000 0000
Phone: x0 000 000 0000
e-mail: xxxxx.xxxxxx@xxxx.xxx
12
with a copy to:
Xxxxxxxxx X. Xxxxxxxx, M.D.,
Chairman and CEO
BioNumerik Pharmaceuticals, Inc.,
Suite 1250,
0000 Xxxxxxxxx Xxxxx
Xxx Xxxxxxx, XX 00000, XXX
Fax: x0 000 000 0000
Phone: x0 000 000 0000
15 ASSIGNMENT
15.1 This Agreement is deemed personal to BioNumerik and Sumika.
Neither Party shall, without prior written consent of the
other Party, assign this Agreement or any of its rights nor
delegate any of its duties or obligations herein. Without
prejudice to clause 10.4 e), both Parties agree not to
unreasonably withhold consent if such an assignment is
contemplated in connection with the sale or merger by a Party
of all or substantially all of its assets to a third Party,
providing the non-assigning Party receives and accepts such
written assurances of continued performance and commitments
from the assignee under this Agreement as it may reasonably
require prior to such an assignment becoming effective. Any
assignment or delegation in derogation of this provision shall
be deemed null and void.
16 GOVERNING LAW AND DISPUTES
16.1 THIS AGREEMENT IS MADE UNDER AND SHALL BE CONSTRUED IN
ACCORDANCE WITH THE LAWS OF THE STATE OF TEXAS, WITHOUT REGARD
TO THE CONFLICTS OF LAW PRINCIPLES THEREOF. ALL TRADE TERMS
PROVIDED IN THIS AGREEMENT SHALL BE INTERPRETED IN ACCORDANCE
WITH THE 1990 EDITION OF INCOTERMS ISSUED BY THE INTERNATIONAL
CHAMBER OF COMMERCE.
Each party to this Agreement hereby irrevocably consents and
submits to the jurisdiction of the courts of the State of
Texas and of the United States of America for all purposes in
connection with any proceeding which arises out of or relates
to this Agreement.
16.2 Any controversy or claim arising out of or relating to this
Agreement, or the breach thereof, shall be settled by
arbitration in accordance with the commercial arbitration
rules of the International Chamber of Commerce. The place of
any arbitration shall be (I) San Antonio, Texas, U.S.A. if
such arbitration is instituted by Sumika and (ii) Osaka, Japan
if instituted by BioNumerik. Judgment upon award rendered by
the arbitrator(s) may be entered in any court of competent
jurisdiction in the United States or Japan .
17 MISCELLANEOUS
17.1 WAIVERS: Failure of either Party at any time to require
strict performance by the other Party of any of the provisions
of the Agreement shall in no way affect the right thereafter
to enforce the same, nor shall the waiver of any term,
provision, covenant or condition hereof be taken or held to be
a waiver of any
13
subsequent breach thereof or as nullifying the effectiveness
of such term, provision, covenant or condition.
17.2 COUNTERPARTS: This Agreement may be executed in two or more
counterparts, which all together shall constitute one
instrument.
17.3 ENTIRE AGREEMENT: This Agreement and its annexes, as well as
the Confidentiality Agreement and the Materials Transfer
Agreement dated March 13, 2000 by and between BioNumerik and
Sumika, embody the entire understanding of the Parties and
shall supersede all previous communications, representations,
or understandings, either oral or written, between the Parties
relating to the subject matter hereof.
17.4 AMENDMENTS: No amendments or modifications of this Agreement
will be deemed legally binding unless made in writing and
signed by both Parties hereto.
17.5 SEVERABILITY: In case one or more of the provisions contained
in this Agreement shall, for any reason, be held invalid,
illegal, or unenforceable in any respect, such invalidity,
illegality or unenforceability shall not affect any other
provision of this Agreement, but this Agreement shall be
construed by amending or limiting such invalid, illegal, or
unenforceable provision so as to conform as closely as
possible to the intent of the Parties or, if such is not
possible, by deleting such provision from this Agreement.
17.6 ANNEXES: The Annexes form an integral part of this Agreement.
Should any internal discrepancies or variances occur between
this Agreement and its Annexes, the Agreement shall take
precedence.
17.7 HEADINGS: The headings in this Agreement may not be used in
the interpretation of any provisions hereof.
17.8 USE OF NAMES: Except as expressly required pursuant to law,
neither Party will without prior written consent of the other:
(a) Use in advertising, publicity, promotional premiums
or otherwise, any trade name, trademark, trade
device, service xxxx, symbol, or any abbreviation,
contraction or simulation thereof owned by the other
Party, or
(b) Represent, either directly or indirectly, that any
product or service of one Party is a product or
service of the other.
17.9 LANGUAGE: The Parties have requested that this Agreement and
all related documents be in English.
17.10 COPIES: This Agreement is established in two (2) copies with
identical language: One copy for BioNumerik and one copy for
Sumika.
14
In Witness Hereof,
the Parties hereto through their authorized representatives have
executed this Agreement as of the date first written above.
SUMIKA FINE CHEMICALS CO., LTD.
By: \s\ Z. WAKAYASHI
----------------------------------------------
Title: Managing Director, Marketing & Sales
Date: 4/10/01
----------------------------------------------
BIONUMERIK PHARMACEUTICALS, INC.
By: \s\ XXXXXXXXX X. XXXXXXXX
----------------------------------------------
Title: Chairman and Chief Executive Officer
Date: 4/12/01
----------------------------------------------
AGREED TO SECTION 7 AND ATTESTED BY:
GRELAN PHARMACEUTICAL CO., LTD.
By: \s\ H. KANAZAWA
----------------------------------------------
Title: C.O.O. and Vice President -- Director
Date: 4/12/01
----------------------------------------------
15
ANNEX 1
QUALITY SPECIFICATIONS AND METHODS
[**]
[**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTION.
ANNEX 2 SUMIKA PRICE SCHEDULE
[**]
[**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTION.
ANNEX 3: SUMIKA WIRE TRANSFER INFORMATION
SUMITOMO MITSUI BANKING CORPORATION
OSAKA HEAD OFFICE
6-5 KITAHAMA, 4-CHOME, CHUO-KU,
OSAKA 541-0041
ACCOUNT NO. 0000000
ANNEX 4
(3 Pages)
LIST OF DMF REQUIREMENTS DATA FOR BNP7787 AND
RESPONSIBLE PARTY FOR DATA/INFORMATION ACQUISITION
[**]
[**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTION.
