EXHIBIT 10.1
MANUFACTURING AGREEMENT
BETWEEN
REAADS MEDICAL PRODUCTS INC.
AND
CHUGAI PHARMACEUTICAL CO. , LTD.
TABLE OF CONTENTS
Article 1. Definition...............................................1
1.1 "Product"...........................................1
1.2 "Developed Product".................................1
1.3 "Patent Rights".....................................2
1.4 "Know-How"..........................................2
1.5 "Affiliate".........................................2
1.6 "Effective Date"....................................2
1.7 "Launch Date".......................................2
1.8 "Net Sales".........................................2
Article 2. Development Fee..........................................3
Article 3. License to RMP...........................................3
Article 4. License to Chugai........................................4
Article 5. Bulk Material............................................4
Article 6. Purchase and Delivery ...................................4
6.1 Purchase Orders.....................................4
6.2 Supply Price........................................4
6.3 Compensation........................................5
6.4 Invoices............................................6
6.5 Delivery............................................6
6.6 Forecasts...........................................7
6.7 Rejection...........................................7
6.8 Quality Assurance...................................8
6.9 Labeling and Trademarks.............................8
6.10 Product Warranty....................................8
6.11 Compliance with Law.................................9
Article 7. Royalty Payments.........................................9
Article 8. Assignment..............................................10
Article 9. Confidentiality Requirement.............................10
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Article 10. Regulatory Matters......................................11
10.1 Export/Import Licenses.............................11
10.2 Regulatory Approvals...............................11
Article 11. Technical Support.......................................12
Article 12. Infringement............................................12
Article 13. Shelf Life; Cancellation and Reschedule Changes.........13
13.1 Shelf Life Warranty................................13
13.2 Notices............................................13
13.3 Third Party Claims.................................13
13.4 Cancellation and Reschedule Charges................14
Article 14. Term....................................................14
Article 15. Termination.............................................14
Article 16. Arbitration.............................................15
Article 17. General Provisions......................................15
17.1 Entire Agreement...................................15
17.2 Waiver, Etc........................................16
17.3 Notices............................................16
17.4 Governing Law......................................16
17.5 Relationship Created...............................16
17.6 Authority..........................................17
17.7 Force Majeure......................................17
17.8 Headings...........................................17
Signature..............................................................18
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MANUFACTURING AGREEMENT
This Agreement is entered into as of this First day of September, 1994, by and
between REAADS Medical Products, Inc. , a Delaware corporation having a
principal place of business at ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇ (hereinafter referred to as "RMP") and Chugai Pharmaceutical
Co. , Ltd. , a corporation organized and existing under the laws of Japan,
having a principal place of business at ▇-▇, ▇▇▇▇▇▇▇▇ ▇-▇▇▇▇▇, ▇▇▇▇-▇▇, ▇▇▇▇▇
▇▇▇, ▇▇▇▇▇ (hereinafter referred to as "Chugai").
WITNESSETH
WHEREAS, Chugai and RMP have entered the Development and Manufacturing
Memorandum on 27th September 1993 to confirm both parties' intention of
improving Chugai's diagnostic kit using RMP's technology and know-how;
WHEREAS, Chugai proposed the Hyaluronic Acid assay from its product line to RMP
as a candidate of such product to be improved, and RMFI conducted the
development of the assay under a collaboration with Chugai;
WHEREAS, Chugai is desirous of marketing such improved Hyaluronic Acid assay kit
worldwide, and RMP is desirous of manufacturing it for export to Japan under the
terms and conditions herein stipulated;
NOW, THEREFORE, in consideration of the mutual covenants and agreements
hereinafter contained, the parties hereto agree as follows:
Article 1. Definition
1.1 "Product" shall mean the Hyaluronic Acid assay developed by Chugai for
quantitation of hyaluronates in human sera, which is currently
manufactured and marketed in Japan by Chugai.
1.2 "Developed Product" shall mean the improved version of Product which was
developed by RMP using RMP's Know-How (defined below, under the
Development and Manufacturing Memorandum.
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1.3 "Patent Rights" shall mean any and all claims made by and all patent
applications and issued patents held by Chugai in the U.S.A. in
connection with the Product, including U.S. Patent No. 5,019,498 issued
on May, 28, 1991, and any and all divisions, continuations,
continuations-in-part, reissues or extensions thereof.
1.4 "Know-How" shall mean the accumulation of skills, processes and
experience, including formulas and specifications, heretofore developed
by RMP pertaining to the REAADS enzyme immunoassay technology,
including, but not limited to, any and all technical information, trade
secrets, test results, studies and analysis, approved vendor list for
any raw materials, preclinical and clinical data, manufacturing data,
formulation or production technology, engineering or assembly methods
and other information necessary or useful in the manufacture, sale and
use of the Developed Product.
1.5 "Affiliate" shall mean and include any individual, corporation,
partnership, limited liability company, joint venture business
association or entity that controls, is controlled by, or is under
common control with the specified party. For purposes of this
definition, "control" shall mean direct or indirect beneficial ownership
of more than fifty percent (50%) of the voting stock or other equity
ownership interest of, and fifty percent (50%) or more interest in the
income of, such entity.
1.6 "Effective Date" shall mean the date as set forth on the first page
hereof, upon which this Agreement shall become effective.
1.7 "Launch Date" shall mean the date upon which the Developed Product is
approved for commercial use in Japan by the Ministry of Health and
Welfare and is officially put into commercial distribution in Japan.
1.8 "Net Sales" shall mean the total invoice or contract price charged by
Chugai or its Affiliates to third parties for the sale of the
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Developed Product, less returns, freight charges, insurance premium and
customary trade discounts actually taken, consumption tax or other taxes
levied and customs duties.
Article 2. Development Fee
Chugai shall compensate RMP pursuant to Article 6.3 hereof in the amount of One
Hundred Fifty Thousand Dollars ($150,000) in full payment for the costs incurred
by RMP in the development of the Developed Product.
Article 3. License to RMP
Subject to the terms and conditions hereinafter set forth, Chugai hereby grants
to RMP a license under the Patent Rights to manufacture the Developed Product
solely for export to Chugai. Such license shall be an exclusive license for ,
period of three (3) years commencing on the Launch Date (the "Three-Year
Period") and shall automatically convert at the end of the Three-Year Period to
a non-exclusive license for the balance of the term of this Agreement; provided,
however, that Chugai may also convert the exclusive license to a non-exclusive
license at any time during the Three-Year Period upon written notice to RMP.
Upon conversion of the exclusive license granted to RMP into a nonexclusive
license, Chugai shall have the rights, pursuant to the license granted to it by
RMP under Article 4 hereof, to manufacture the Developed Product in its
facilities or to have the Developed Product manufactured by any other party.
Chugai shall pay a royalty to RMP in respect of such license equal to three
percent (3%) of its Net Sales of the Developed Product manufactured by a party
other than RMP during the term of this Agreement. In addition, if Chugai elects
to convert the license to a nonexclusive license prior to the end of the
Three-Year Period, Chugai shall pay to RMP, in addition to such three percent
(3%) royalty, a transfer
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fee equal to two percent (2%) of its Net Sales during the Three-Year Period of
the Developed Product manufactured by a party other than RMP, such transfer fee
being intended to compensate RMP for profits that RMP would have realized
through the manufacture of such Developed Product during the entire Three-Year
Period.
Article 4. License to Chugai
Subject to the terms and conditions set forth in Article 3 above, RMP hereby
grants to Chugai an exclusive, perpetual, transferable right and license under
the Know-How to make, use, sell and distribute the Developed Product worldwide
including the right to sublicense.
Article 5. Bulk Material
The bulk materials to be incorporated into the Developed Product may be provided
by Chugai, or be procured by RMP itself if both parties desire so.
Article 6. Purchase and Delivery
6.1 Purchase Orders
All purchase orders and amendments thereto shall be in writing and shall contain
(i) all technical information necessary for RMP to accurately supply the
Developed Product, (ii) quantity, (iii) date of requested delivery, and (iv)
preferred shipping instructions. All such purchase orders shall be deemed
accepted by RMP unless, within one (1) week following receipt of the purchase
order, RMP gives written notice to Chugai of non-acceptance thereof stating the
reasons therefor. Acceptance of purchase orders complying with the terms of this
Agreement may not be withheld by RMP.
6.2 Supply Price
The supply price per kit at which RMP shall sell the Developed Product to Chugai
hereunder ( "Supply Price") shall be negotiated in good faith
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between the parties in view of RMP's cost, Chugai's pricing at the retail level
in Japan and other market conditions. All purchase orders shall be fulfilled at
the Supply Price that is in effect on the date of receipt of the purchase order
by RMP.
The Supply Price shall initially be set by the parties prior to the Launch Date
and shall be adjusted as necessary before December 1 each year, beginning with
the first December 1 following the Launch Date. Such adjusted Supply Price shall
be applied effective January 1 throughout the next calendar year. No adjustment
to the Supply Price shall reflect an increase greater than the rate of increase
in the United States Consumer Price Index - All Urban Consumers, published by
the United States Department of Commerce since the date of the previous
adjustment. The Supply Price shall not exceed twenty-two percent (22%) of
Chugai's retail price in Japan for the Developed Product nor be less than RMP's
fully burdened manufacturing cost plus forty percent (40%).
Should the parties be unable to agree on adjustment of the Supply Price for any
calendar year by December 1 of the prior year, the Supply Price for such prior
year shall continue in effect for the first six (6) months of such following
calendar year. Should the parties remain unable to agree on adjustment of the
Supply Price by June 1, the Supply Price for the last six (6) months of such
year shall be determined by a mutually agreeable conciliator at a mutually
agreeable place.
6.3 Compensation
Notwithstanding the foregoing provisions of this Article 6, in order for RMP to
recover its costs associated with the development of the Developed Product in
accordance with Article 2 hereof, Chugai shall purchase the first ten thousand
(10,000) kits supplied by RMP hereunder at a price per kit equal to the Supply
Price then in effect, as determined pursuant to Article 6.2 hereof, plus Fifteen
Dollars ($15) per kit. If Chugai should elect to utilize a manufacturer for the
Developed Product other than RMP prior to purchasing ten thousand C10,000) kits
from RMP hereunder, Chugai shall satisfy its obligation to RMP in respect of
such development costs by making a lump-sum payment to RMP equal to One Hundred
Fifty Thousand
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Dollars ($150,000) less the aggregate number of kits purchased from RMP times
Fifteen Dollars ($15).
6.4 Invoices
RMP shall invoice Chugai at its address set forth in Article 17.3 below at the
time of each shipment of the Developed Product. Invoices shall not be issued
prior to shipment of all items covered by the invoice. Invoices shall contain
the purchase order number, description of items purchased, price, freight
charges and total. Payment shall be made by Chugai to RMP in US dollars.
6.5 Delivery
RMP shall deliver the Developed Product in accordance with Chugai's shipping
instructions within thirty (30) days following RMP's receipt of Chugai's
purchase order; provided that if the order exceeds by more than 10% the
corresponding six month forecast as provided in Article 6.6, RMP shall have
forty-five (45) days to deliver the requested Developed Product. All the
Developed Product shall be delivered to Chugai in finished and packaged form,
C&F Tokyo International Airport, to the address specified in the applicable
purchase order. RMP shall be responsible for boxing, crating, handling, storage
and all other packaging requirements prior to shipment. Risk of loss shall pass
when the Developed Product are delivered to the carrier in accord with the
Chugai's shipping instructions, and delivery to Chugai shall be considered to
occur at such time. All the Developed Product shall be packed, marked and
otherwise prepared for shipment in a manner which is in accordance with good
commercial practice and adequate to ensure the safe arrival of the Developed
Product.
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If RMP wants to change the scheduled delivery date or the quantity to deliver
which RMP accepted in accordance with the Article 6.1, RMP shall notify Chugai
of the change in writing at least seven (7) days prior to the delivery date
originally scheduled. If, for any reason, other than as expressly provided for
in this Agreement, RMP fails to despatch, without prior notice to Chugai as set
forth hereinabove, all quantities of the Developed Product which Chugai ordered
within five (5) business days after the delivery date originally scheduled, RMP
agrees to pay to Chugai ten percent (10%) of total invoice amount of the order
placed by Chugai.
6.6 Forecasts
Every six (6) months during the term of this Agreement, on or before May 31 and
November 30 of each year, Chugai shall submit to RMP a non-binding forecast of
its estimated requirements of the Developed Product for the corresponding six
(6) month period commencing on the following July 1 and January 1, respectively.
Chugai agrees that all such forecasts shall be prepared in good faith in order
to facilitate RMP's timely manufacture and shipment of the Developed Product in
accordance with the terms and conditions of this Agreement.
6.7 Rejection
All Developed Product shall be subject to inspection and acceptance by Chugai.
In the event that Chugai believes that any of the Developed Product shipped by
RMP to Chugai hereunder do not meet the quality standards and specifications to
be mutually agreed separately in advance of the Launch Date, Chugai shall have
the right to reject such shipment by giving RMP prompt notice thereof. Upon
receipt of any such notice, RMP may at its option obtain samples of the rejected
shipment from Chugai for analysis. At Chugai's option, Chugai may either request
RMP to promptly deliver a new shipment of the Developed Product to replace the
rejected shipment or return the rejected shipment to RMP so that RMP may cure
all defects and deficiencies and deliver the corrected shipment to Chugai within
thirty (30) days after RMP's receipt of such returned shipment. In either event,
RMP shall bear all freight costs in the delivery of the Developed Product
between Chugai and RMP.
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6.8 Quality Assurance
RMP shall strictly adhere to such quality control procedures as may be necessary
to ensure that the Developed Product will be manufactured and perform in
accordance with Chugai's specifications and as may be otherwise necessary to
meet all applicable governmental specifications and requirements for the
manufacture of the Developed Product. RMP shall certify to Chugai with respect
to each such shipment that all such procedures and specifications have been met
and complied with, and shall furnish Chugai with copies of the test results and
other definitive data supporting its certification if requested in writing.
6.9 Labeling and Trademarks
The Developed Product, including labels, packaging and product inserts, shall
bear such trade names, trademarks, designs and logos as may be designated and
supplied by Chugai, subject to the requirements of applicable law.
6.10 Product Warranty
All the Developed Products furnished by RMP to Chugai hereunder shall be
warranted (i) to be manufactured in accordance with applicable product
specifications; (ii) to be manufactured in accordance with good manufacturing
practices as defined by FDA regulations; (iii) to be free from defects in
formulation and manufacture under the normal use and service for which they were
designed; (iv) to be suitable for sale to the public in accordance with the
terms of the Developed Product's labels and inserts; and (v) as to RMP's good
title and conveyance of good title to Chugai; provided, that the foregoing
warranty of good title shall not extend to the defect derived from the Chugai
technology incorporated ir the Developed Product. Such warranties shall run to
Chugai, and its Affiliates, successors, assigns and users of the Developed
Product and shall expressly survive any inspection, delivery, acceptance,
payment, expiration or earlier termination of this Agreement. The warranties of
RMP set forth in this Article 6.10 are the sole and exclusive warranties
provided to Chugai, its successors, assigns and users of the Developed
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Product, and are in lieu of all other warranties, whether written or oral,
implied or statutory. RMP shall not be liable to Chugai for any loss of profits
or other special, indirect or consequential damages suffered by Chugai resulting
from the failure of or a defect in any Developed Product, provided, however,
that no such limitation shall apply with respect to any such damages suffered by
unaffiliated third parties. All the Developed Product labels and product inserts
shall appropriately reflect the product warranties, and limitations thereof,
provided by this Article 6.10. RMP shall not be responsible to Chugai or
Chugai's agents for any breach of warranty hereunder which results solely from
Chugai's willful misconduct or negligence in handling of the Developed Product,
to the extent RMP has theretofore fully disclosed to Chugai the appropriate way
of handling the Developed Product when particular cautions are required in
connection therewith.
6.11 Compliance with Law
RMP shall take all necessary action to comply with all applicable FDA
regulations and other U.S. legal requirements in connection with the manufacture
of the Developed Product. Such obligations shall include, without limitation,
complying with all applicable good manufacturing practices and good laboratory
practices as promulgated under applicable U.S. law, and all other applicable
U.S. federal, state or local low or regulations. Chugai shall have the right
upon reasonable notice to RMP to inspect RMP's manufacturing facilities and
operations and quality control records to review and inspect the manufacture of
the Developed Product, to audit and confirm compliance with the requirements of
this Article 6.11 and to trace production in connection with any recall, product
liability or other problems related to the manufacture. Any such inspection or
right to inspect by Chugai shall in no way relieve RMP of its obligation to
deliver the Developed Product conforming to the terms and specifications set
forth in this Agreement, or Chugai's right to inspect and reject the Developed
Product.
Article 7. Royalty Payments
If any royalty or transfer fee payments shall become payable from Chugai
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to RMP pursuant to Article 3 hereof , Chugai shall remit such payments to RMP,
within ninety (90) days after the close of the calendar quarter to which such
payments relate together with a report of the amount of the Net Sales of the
Developed Product sold by Chugai and its Affiliates, and the amount of royalty
and transfer fee payments due to RMP.
Chugai shall make all payments in the United States Dollars after deduction of
any applicable withholding tax. All amounts due on the Net Sales made in
Japanese Yen shall be converted to United States Dollars on the basis of the
T.T. Selling rate at the Sumitomo Bank in Tokyo on the last business day of the
period for which such payment relates.
Article 8. Assignment
Neither party shall assign this Agreement without the prior written consent of
the other party hereto, except to (i) an Affiliate of such party, (ii) a
transferee of substantially the entire business of such party to which this
Agreement pertains or (iii) a successor to such party by merger or
consolidation. Any assignee shall assume all obligations of its assignor under
this Agreement. No assignment shall relieve any party of responsibility for the
performance of any accrued obligation which such party then has hereunder. This
Agreement shall be binding on and inure to the benefit of the respective
successors and permitted assigns of the parties. Except as expressly provided
herein, no other person shall acquire or have any right under or by virtue of
this Agreement.
Article 9. Confidentiality Requirement
Each party acknowledges that during the course of this Agreement it will become
privy to confidential information of the other party including technology,
business strategy, and other technical, business and financial matters. Each
party further acknowledges that the disclosure of such information to a third
party, or the use of such information for purposes other than the purposes of
this Agreement, would cause irreparable injury to the other party, which injury
might not be compensated for adequately by money damages. Each party accordingly
agrees during the term of this agreement to hold all information provided
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by the other party in strictest confidence and not to disclose any such
information to a third party except as expressly permitted by the other party,
or use such information for any purpose other than the purposes hereof. This
Article shall survive any termination of this Agreement for a period of three
(3) years.
As used herein, the term "confidential information" shall not include
information that (i) is or becomes generally available to the public other than
as a result of disclosure by receiving party, (ii) was available to receiving
party on a nonconfidential basis prior to its disclosure by disclosing party or
(iii) becomes available to receiving party on a nonconfidential basis from a
source other than disclosing party that is not otherwise prohibited from
disclosing such information.
Article 10. Regulatory Matters
10.1 Export/Import Licenses
RMP shall be responsible for obtaining all export licenses or permits required
by the U.S. government for any of the Developed Product and will use its
reasonable business effort to obtain such licenses as expeditiously as possible,
as well as the cost of such licenses and permits. Chugai shall be responsible
for obtaining all licenses and permits required by any governmental authority in
order to import the Developed Product into Japan, as well as the cost of such
licenses and permits. Each party agrees to comply with all applicable laws,
regulations and orders governing the sale, disposition, shipment, import or
export of the Developed Product and maintain in effect all licenses, permits and
authorizations from all government agencies as may be necessary to perform its
obligations hereunder.
10.2 Regulatory Approvals
Chugai shall be responsible for, and shall bear the expense of, filing and
prosecuting any application to obtain the required governmental approvals or
consents necessary to manufacture, test and market the Developed Product in
Japan, RMP shall, however, provide Chugai, at no
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cost to Chugai, with all technical and regulatory documentation and information,
including, without limitation, all clinical data, in RMP's possession or under
its control, or obtainable without unreasonable burden to RMP.
Article 11. Technical Support
RMP shall provide training and technical assistance to Chugai's personnel
necessary for the marketing of the Developed Product. Such technical assistance
and training shall be provided at RMP's facility in Westminster, Colorado, or,
if agreed by the parties, at Chugai's premises. Such technical assistance and
training shall be provided by RMP at no charge to Chugai, except that if the
training is performed at Chugai's premises, Chugai shall reimburse RMP for the
reasonable expenses of RMP's personnel for travel, meals, and lodging upon
submission of documentary evidence thereof. If training is provided at RMP's
facility in Westminster, Colorado, Chugai shall bear all expenses of travel,
meals and lodging for its personnel. All technical assistance and training shall
be performed at times convenient to both parties.
Article 12. Infringement
In the event any claim is brought against RMP or Chugai by any third party
alleging infringement of the third party's patents or other property right for
manufacture, use, or sale of the Developed Product, (a) Chugai will cooperate
with RMP at RMP's cost as reasonably requested by RMP in defense of any such
claims brought against RMP, and (b) RMP will cooperate with Chugai at RMP's cost
in defense of any such claims brought against Chugai.
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Notwithstanding the foregoing, Chugai shall be solely liable for any claim of
infringement involving the Developed Product, which is based solely on Chugai
technology included in the Developed Product, and shall indemnify, defend and
hold harmless RMP from any liability resulting from such claim including
reasonable attorney's fees as incurred, and RMP shall be solely liable for any
claim of infringement involving the Developed Product, which is based solely on
RMP's Know-How, and shall indemnify, defend and hold harmless Chugai from any
liability resulting from such claim including reasonable attorney's fees as
incurred.
Article 13. Shelf Life; Cancellation and Reschedule Changes
13.1 Shelf Life Warranty
RMP warrants that the Developed Product shall have a shelf life, at the time of
receipt by Chugai, of at least eighty percent (80%) of the shelf life stated on
the label or product insert. RMP shall not be liable for any failure to satisfy
the shelf life requirement to the extent such variance is caused by conditions
or events occurring after shipment over which RMP has no control.
13.2 Notices
Should Chugai discover any Developed Product which fails to satisfy the shelf
life warranties contained in Article 13.1, Chugai shall notify RMP in writing
within fifteen (15) business days after such discovery. RMP shall, at Chugai's
election, either refund the portion of the purchase price to Chugai, allocable
to the Developed Product which gives rise to the claim, or correct such defect
by suitable replacement at its own expense. RMP's obligation under this section
shall be conclusively discharged, to the extent permitted under applicable laws,
if RMP does not receive written notification of any defect within fifteen (15)
business days after its discovery.
13.3 Third Party Claims
The provisions of these Articles 13.1 and 13.2 are not applicable to any
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third party claims.
13.4 Cancellation and Reschedule Charges
If, for any reason, other than as expressly provided for in this Agreement,
Chugai (i) cancels all or any part of any order, or (ii) fails to meet any
obligation hereunder, causing cancellation or rescheduling of any order or
portion thereof, or (iii) requests a rescheduling of scheduled shipments of the
Developed Product, and the request is accepted by RMP, Chugai agrees to pay to
RMP the following cancellation/reschedule charges:
CANCELLATION OR RESCHEDULE NOTICE CANCELLATION OR RESCHEDULE
RECEIVED CHARGE
Within 7 days after the date of 20% of invoice amount of the Developed
placing purchase order by Chugai Product not taken
Thereafter up to scheduled delivery 30% of invoice amount of the
Developed Product not taken
The aforementioned charges shall not apply in case that the events described in
the first paragraph of this Article 13.4 are due to events of force majeure as
defined in Article 17.7.
Article 14. Term
Unless earlier terminated by either party, this Agreement shall be effective for
seven (7) years from the Effective Date, and shall be automatically renewed
after the initial term for successive one (l)-year period each unless terminated
by either party as provided in Article 15 hereof.
Article 15. Termination
Either party will have the right to terminate this Agreement if the other
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party; (a) assigns this Agreement or any of these rights hereunder in violation
of the provisions of this Agreement; (b) becomes bankrupt or insolvent; (c)
makes an assignment for the benefit of creditors, or a receiver, trustee in
bankruptcy or similar officer is appointed to take charge of all or part of its
property; or (d) materially breaches its obligations under this Agreement, and
such breach has not been cured within thirty (30) days of written notice thereof
by the non-breaching party. In addition, each party will have the right to
terminate this Agreement at the end of the initial term and of each subsequent
term as provided for in Article 14 above upon six (6) months prior written
notice. The provisions of Articles 4, 6.10, 9, 12, 13.1 and 16 hereof, and the
obligations of the parties to make payments to each other pursuant to any other
provision of this Agreement in respect of transactions accruing prior to the
termination date, shall survive the termination of this Agreement.
Article 16. Arbitration
Any controversy or claim arising under or in relation to this Agreement, except
as otherwise expressly provided below, shall be settled exclusively by
arbitration in accordance with the Intentional Arbitration Rules of the
International Chamber of Commerce (ICC). Arbitration shall take place in Paris,
France. The arbitration shall be conducted in English. The cost incurred by the
arbitration shall be borne equally by the parties except for each attorneys'
fees which shall be borne by each party. The decision of the arbitrators shall
be final and binding on the parties, and judgment upon the award rendered by the
arbitrators may be entered by any court having jurisdiction thereof.
Article 17. General Provisions
17.1 Entire Agreement
This Agreement constitutes the entire agreement between the parties with respect
to the subject matter hereof, and may not be modified unless expressly provided
otherwise herein except by a written agreement or addendum hereto duly signed by
both parties. The terms and conditions of
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this Agreement shall prevail notwithstanding any other terms and conditions on
any order submitted by Chugai.
17.2 Waiver, Etc,
Except where specific time limits are herein provided, no delay on the part of
either party hereto in exercising any power or right hereunder shall operate as
a waiver thereof, nor shall any single or partial exercise of any power or right
hereunder preclude other or urt er exercise thereof or the exercise of any other
power or right. No waiver, modification or amendment of this Agreement or any
provision hereof shall be enforceable against any party hereto unless in
writing, signed by the party against whom such waiver, modification or amendment
is claimed, and with regard to any waiver, shall be limited solely to the one
event.
17.3 Notices
Any notices or report required or permitted under this Agreement must be in
writing and by mail, registered or certified, postage prepaid addressed to the
other party at address set forth hereinbelow, or to such other address as
designated by written notice given to the other party:
If to RMP: If to Chugai:
▇▇. ▇▇▇▇ ▇. ▇▇▇▇▇ General Manager
President Diagnostics Division
REAADS Medical Products, Inc. Chugai Pharmaceutical Co., Ltd.
▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇ 21-1, Nishi-Shinjuku I-Chome
▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Shinjuku-ku, Tokyo 160
U.S.A. Japan
17.4 Governing Law
The validity and interpretation of this Agreement shall be governed and
construed according to the laws of the State of Delaware, U.S.A.
17.5 Relationship Created
The parties intend that the relationship between them created by this
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Agreement be that of independent contractors, and nothing in this Agreement
shall be construed as establishing an agency relationship, a joint venture or a
partnership between the parties.
17.6 Authority
Each party hereby represents and warrants that it has full power and authority
to enter into and perform this Agreement, without any governmental approvals,
and that its entering into and performance of this Agreement will not conflict
with any other agreement to which it is party or by which it is bound.
17.7 Force Majeure
Each party shall be relieved of its obligations under this Agreement to the
extent, and only to the extent, that fulfillment of such obligations shall be
prevented by acts of war, labor difficulties, riots, fire, earthquake, flood,
hurricane, windstorm, acts or defaults of common carrier, governmental laws,
acts or regulations, shortages of materials or any other occurrences, whether or
not similar to the foregoing, beyond the reasonable control of the affected
party.
17.8 Headings
The headings of Articles and Sections herein are for convenience of reference
only and shall not affect the meaning or construction of the provisions of this
Agreement.
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IN CONSIDERATION OF the foregoing terms and conditions, Chugai and RMP have
executed this Agreement on the day and year first written above.
REAADS Medical Products, Inc. Chugai Pharmaceutical Co., Ltd.
By /s/ ▇▇▇▇ ▇. ▇▇▇▇▇ By /s/ ▇▇▇▇ ▇▇▇▇
------------------------------- ----------------------------------
▇▇▇▇ ▇. ▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇
President Director and General Manager
Diagnostic Division
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