EXHIBIT 10.3
AMENDMENT AGREEMENT
This AMENDMENT AGREEMENT is made as of the 17 day of November, 1997.
by and between
Chugai Diagnostics Science Co., Ltd., a Japanese corporation having its
principal office at 0 - 00 - 0 Xxxxxx, Xxxxxxx-xx, Xxxxx, Xxxxx (hereinafter
called "CDS")
and
Reaads Medical Products Inc., a Delaware corporation having its principal office
at 00000 Xxxxx Xxxxxx, Xxxxxxxxxxx, Xxxxxxxx 00000, XXX (hereinafter called
"RMP")
WHEREAS, Chugai Pharmaceutical Co. Ltd., which owns 100% share of CDS,
(hereinafter called the "CSK") and RMP have entered into a Manufacturing
Agreement dated as of September 1st, 1994, providing for manufacturing Developed
Products for export to Japan (hereinafter called the "Original Agreement');
WHEREAS, CSK assigned the Original Agreement to CDS as of the day of October 1,
1997; and
WHEREAS, CDS and RMP desire to amend the Original Agreement to provide that the
export of Products to the third party designated by CDS;
NOW THEREFORE, in consideration of the mutual covenants and promises contained
herein, the parties hereto hereby agree as follows:
1. Definitions
All terms used herein shall have the meanings set forth in the Original
Agreement except as otherwise defined herein.
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2. Amendment
(a) The first paragraph of Article 3 of the Original Agreement is hereby
deleted and a new first paragraph of Article 3 is hereby inserted in its
place to read in its entirety as follows:
Subject to the terms and conditions hereinafter set forth, Chugai hereby
grants to RMP a license under the Patent Right to manufacture the
Developed Product solely for export to Chugai or the third party
designated by Chugai. Such license shall be an exclusive licence for a
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 nonexclusive license at any time during the Three-Year
Period upon written notice to RMP.
(b) The first paragraph of Article 6.2 of the Original Agreement is hereby
deleted and a new first paragraph of Article 6.2 is hereby inserted in
its place to read in its entirety as follows:
The supply price per kit at which RMP shall sell the Developed Product
to Chugai or the third party designated by Chugai hereunder ("Supply
Price") shall be negotiated in good faith 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.
(c) The first paragraph of Article 6.5 of the Original Agreement is hereby
deleted and I new first paragraph of Article 6.5 is hereby inserted in
its place to read in its entirety as follows:
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 delivered to
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Chugai shall be delivered in finished and packaged form, C&F Tokyo
International Airport, to the address specified in the applicable
purchase order, and all the Developed Product delivered to the third
xxxxx designated by Chugai shall be delivered in finished and packaged
form, FCA at Denver, to the said third parties' 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.
(d) Article 6.7 of the Original Agreement is hereby deleted and a new
Article 6.7 is hereby inserted in its place to read in its entirety as
follows:
All Developed Product shall be subject to inspection and acceptance by
Chugai or the-third party designated by Chugai on behalf of Chugai. In
the event that Chugai believes that any of the Developed Product shipped
by RMP to Chugai or the third party designated by 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 or the third party designated by 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 among Chugai, the third party designated by Chugai,
and RMP.
(e) Article 6.10 of the Original Agreement is hereby deleted and a new
Article 6.10 is hereby inserted in its place to read in its entirety as
follows:
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All the Developed Products furnished by RMP to Chugai and the third
party designated by 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 and the third
party designated by Chugai; provided, that the foregoing warranty of
good title shall not extend to the defect derived from the Chugai
technology incorporated in 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, users
of the Developed Product, and the third party designated by Chugai, 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 form 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 Chiugai'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.
(f) Article 6.11 of the Original Agreement is hereby deleted and a new
Article 6.11 is hereby inserted in its place to read in its entirety as
follows:
RMP shall take all necessary action to comply with all applicable FDA
regulations, other U.S. legal requirements, and UK legal requirement in
connection with the manufacture of the Developed Product. Such
obligations shall include, without limitation, complying with all
applicable good manufacturing practices and good
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laboratory practices as promulgated under applicable U.S. law and UK
law, and all other applicable U.S. federal, state or local law or
regulations, or UK law 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.
(g) Article 13.1 of the Original Agreement is hereby deleted and a new
Article 13.1 is hereby inserted in its place to read in its entirety as
follows:
RMP warrants that the Developed Product shall have a shelf life., at the
time of receipt by Chugai or the third party designated 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.
(h) Article 13.3 of the Original Agreement is hereby deleted and a new
Article 13.3 is hereby inserted in its place to read in its entirety as
follows:
The provisions of these Articles 13.1 and 13.2 are not applicable to any
third party claims, except the third party designated by Chugai to
deliver Developed Product.
3. Effective Date
This Amendment Agreement shall become effective as of the day and year
first above written.
4. Original Agreement Remains in Full Force and Effect
Except as specifically amended hereby, all the terms and provisions of
the Original Agreement shall remain in full force and effect, and the
Original Agreement as amended by this Amendment Agreement shall, upon
becoming effective in
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accordance with Section 3 hereof, read as a single integrated document
incorporating the changes effected by this Amendment Agreement.
IN WITNESS WHEREOF, the parties hereto have caused this Amendment Agreement to
be executed by their respective duly authorized representatives as of the, day
and year first written above.
CHUGAI DIAGNOSTICS SCIENCE CO., LTD.
By: /s/ Xxxxxxxxx Xxxxx
-------------------------------------
Name: Xxxxxxxxx Xxxxx
Title: President and CEO
REAADS MEDICAL PRODUCTS INC.
By: /s/ Xxxx X. Xxxxx
-------------------------------------
Name: Xxxx X. Xxxxx
Title: President and CEO
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