Exhibit 10.2.1
AMENDMENT AGREEMENT
between
XXXXX XXXX LABORATORIES (PTY) LIMITED
(Registration Number 92/04344/07)
of
00 Xxxx Xxxxxx, Xxxxxxxxx, XXXXXXXX, 0000
Republic of South Africa
(hereinafter referred to as "MZL")
and
IMX PHARMACEUTICALS, INC.
a corporation organized under the laws of
the State of Utah, United States of America,
and having its principal place of business at
0000 Xxxxxxxxx Xxxxxxxxx #000
Xxxx Xxxxx, Xxxxxxx 00000
Xxxxxx Xxxxxx of America
(hereinafter referred to as "IMX")
MATTERS RECORDED:
A. MZL is the exclusive licensee world-wide in respect of pharmaceutical
preparations developed by Xx. Xxxx Xxxxx and in respect of which
preparations Pitmy International NV hold certain patent rights and is the
proprietor of pending applications including U.S. Patent Application
08/318,626;
B. MZL has granted distribution rights for the USA and Israel and has options
on certain other countries in respect of some of the preparations which
are the subject of the aforementioned patent rights and patent
applications to Interderm Limited, a company organized under the laws of
Gibraltar, which company has in turn ceded such rights, with the consent
of MZL, to IMX;
C. MZL and Pitmy International NV are continuing to develop new preparations
falling within the scope of the aforementioned patents and patent
applications;
D. IMX was appointed as exclusive distributor for such new products as may in
future be developed by MZL and/or Pitmy International - under First
Renewal Agreement dated October 17, 1995, and amended August 7, 1996.
E. MZL wishes to announce its annual reviewed prices in terms of its current
international distribution contract.
F. Pursuant to a Recapitalization Agreement dated October 16, 1997, among
IMX, MZL and certain other shareholders of IMX, at the closing of the
transactions contemplated in the Recapitalization Agreement, MZL shall
shortly receive the sum of $50,000 for the transfer to IMX of 512,252
shares of IMX's common stock. In addition, IMX has agreed to include
400,000 shares of IMX's common stock owned by MZL in a Registration
Statement to enable the shares to be publicly sold by MZL in accordance
with the terms of the Recapitalization Agreement.
G. Pursuant to the terms of Paragraph F and with the view towards increased
market penetration as well as a lower price to the consumer, it has been
decided to implement a substantial price decrease.
H. MZL wishes to enhance the profitability of its distributors by increasing
product range without the cost of an up-front fee.
THEREFORE, the parties agree as follows:
DEFINITIONS:
a. The "Territory" is the USA, Israel and any other countries IMX acquires
distribution rights to pursuant to the Distributorship Agreement dated
June 23, 1995, as amended.
b. "New Products": Those products currently classified as "fast track topical
OTC products as defined in terms of the USA Code of Federal Regulations 21
as selected and developed by MZL" excluding products that MZL may develop
for outside parties that may fall in the above classification but not
competing with any products already licensed; and
c. "Current Products": Those products forming part of the distributorship
agreement dated June 23, 1995, as amended.
1. RIGHTS GRANTED
MZL hereby undertakes in favor of IMX that as long as IMX enjoys the
rights to distribute the products in terms of its current distribution
agreement the exclusive right to distribute new products will first be
offered to IMX allowing IMX a period of 60 days to accept such
distributorship as per procedure and terms contained in Paragraph 2.2.
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2. TERMS OF SALE TO DISTRIBUTOR
For the sake of clarity, terms of sale will be distinguished between
current products and new products.
2.1 CURRENT PRODUCTS
2.1.1 Effective January 1, 1998, MZL shall discount the prices on
current products sold to IMX pursuant to Exhibit A attached
hereto on all orders placed by IMX with MZL. In the event that
MZL has not received at least the sum of $2,000,000 in gross
proceeds from the sale of its shares pursuant to the
Registration Statement, MZL shall have the option to terminate
the discount on all orders placed subsequent to its
notification to IMX of the termination of the discount and
increase the prices by 20% of the prices as referred to in
Exhibit A. However, at such time as MZL receives at least
$2,000,000 in gross proceeds of its shares pursuant to the
Registration Statement, the Exhibit A discount shall be
reinstated. MZL agrees that it will provide the same reduction
to all of its existing licensees, upon the conditions set
forth in this Paragraph 2.1.1.
2.1.2 On or before the seventh day of the following month, IMX will
submit to MZL a monthly report, in the form attached hereto as
Exhibit "1", which will reflect sales made on MZL product
units for the previous month. The report shall constitute an
irrevocable purchase order for MZL to ship products to IMX for
the next month. IMX may increase the size of the order placed
in any month to satisfy its market requirements. In the event
that there are material adverse business conditions that
affect IMX's business, it shall have the right to decrease the
size of its orders. Material adverse conditions shall include,
but shall not be limited to, loss of a major customer(s),
material decrease in sales and force majeure.
2.1.3 Should no orders be received for three consecutive months,
then MZL will place the distributor on 30-day terms and MZL
will have the right to cancel the distributors agreement at
its election, should the distributor remain in breach.
2.1.4 In the event that IMX wishes to market a new product which
will not be manufactured by MZL as an FDA OTC product under
the Exorex name, it shall send to MZL a copy of the FDA
application for the new product. MZL shall have 14 days to
review the application. If MZL determines that marketing of
the new product under the Exorex name will be harmful to the
Exorex goodwill, it must advise IMX within 14 days of its
receipt of the FDA application of its determination. If it
does not so notify IMX, IMX shall be free to proceed with its
marketing of the new product under the Exorex name. If it does
notify IMX within this time
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period, then IMX shall have 14 subsequent days to respond to
MZL to persuade MZL to change its determination. If agreement
can not be reached within that period of time, the matter
shall be turned over to arbitration before a mutually
agreeable third party pharmaceutical company which will make a
determination that will be binding upon the parties as to
whether marketing of the new product under the Exorex name
will be harmful to the goodwill attached to the Exorex name.
IMX shall have the right at any point during this process to
elect not to market the product under the Exorex name and
proceed to market it under a different name.
2.2 NEW PRODUCTS
2.2.1 Effective as of January 1, 1998, MZL shall eliminate any
up-front charges in connection with new products to be
marketed by IMX. In the event, however, that MZL does not
receive at least $2,000,000 of gross proceeds from the sale of
shares under the Registration Statement by April 30, 1998, it
may, at its option, reinstitute an up-front charge policy for
new products and may keep it in effect until it does receive
$2,000,000 of gross proceeds.
The offer of distributorship contemplated in Paragraph 1 shall:
2.2.2 Be made in writing; however, upon receipt of the offer in
writing in the event that IMX is contemplating marketing a
similar product to be manufactured by others, it shall have
the right to advise MZL of this and may proceed with its
efforts to market its product without any claim of violation
of confidentiality obligations to MZL. If IMX desires to
proceed with discussions on marketing of the MZL new product,
then following steps shall be taken:
2.2.3 MZL shall supply a sample of the product offered for
distribution;
2.2.4 MZL shall set out the price at which the product is offered,
which price shall be applicable for a period of one year from
the date upon which IMX received regulatory approval or any
other approvals it needs in order to market the product in the
Territory;
2.2.5 MZL shall supply such product documentation as MZL at the time
has in its possession and which may serve to assist IMX in
procuring product registration and FDA or other approval for
the marketing of the product in the Territory;
2.2.6 MZL shall specify a time period within which FDA or other
regulatory approval shall be obtained as specified in the
paragraph below;
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2.2.7 All product registrations in Europe to be applied through
RX-Holdings Gibraltar who will then cede the license to the
relevant distributor for the term of the distribution
agreement;
2.2.8 RX-Holdings will be the standardizing and coordinating body
for all marketing activities in Europe.
2.3 Should IMX elect to be appointed distributor of the new product
offered to it, it shall:
2.3.1 notify MZL in writing within 60 days of it having received the
offer as contemplated above;
2.3.2 confirm that the period to obtain regulatory approval as
specified by MZL, which shall be at least 90 days, as provided
in Paragraph 2.2.6 above, in its opinion a reasonable period
for that purpose;
2.3.3 present MZL with minimum purchase quantities for the next five
years to be agreed upon by both parties;
2.3.4 If actual purchases by IMX are fifteen percent (15%) lower
than the agreed level during two consecutive years, MZL will
have the option of terminating IMX sales rights 60 days
following the end of the second of those years. In considering
the exercise of these rights, MZL agrees to take reasonable
extenuating circumstances into account. Furthermore, if IMX's
sales rights are terminated for any reason, IMX shall have the
right to sell off its inventory of the product in an orderly
manner, or alternatively, MZL can repurchase the product at
IMX's cost.
2.4 It is an explicit term of this Agreement despite anything to the
contrary herein contained, that should IMX not be able to procure
the requisite marketing approval for the product in the territory
within the term stipulated by MZL in terms of Paragraph 2.2.6 and
agreed to by IMX in terms of Paragraph 2.3.2, then in that event:
2.4.1 IMX shall notify MZL in writing of such inability;
2.4.2 IMX shall hand over, free of charge to MZL, all records in
connection with its attempts to procure marketing approval;
2.4.3 MZL shall thereafter be at liberty to market the new product
itself or appoint another distributor and shall be entitled to
utilize any part of the records acquired in terms of Paragraph
2.4.2.
2.5 In the event of IMX not accepting the distributorship offered to it:
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2.5.1 MZL shall be at liberty to offer such distributorship to any
party;
2.5.2 IMX shall return all samples and documentation handed to it in
respect of the new product and shall thereafter refrain from
utilizing such information in any manner whatsoever;
2.5.3 IMX shall maintain confidentiality with regard to all
confidential information in respect of the new product.
2.6 The rights granted to IMX are personal to IMX and shall not be
assigned to any other party without the prior written consent of
MZL, which consent shall not be unreasonably withheld. In this
regard, it shall be unreasonable for MZL to withhold consent if the
proposed assignee has a net worth at least three times as great as
the net worth of IMX, or the proposed sales of products through the
prospective assignee represents a significant increase in IMX's
business.
2.7 IMX binds itself to operate within the acts promulgated by the
relevant regulatory authorities be they domestic or international.
2.8 This Agreement will be governed by the laws of the Republic of South
Africa.
THUS DONE AND SIGNED at ____________________________________________ on
this _____ day of _______________, 1998.
Witnessed: XXXXX XXXX LABORATORIES (PTY)
LIMITED
_______________________________ By:________________________________________
___________________, its ______________,
he being duly authorized to do.
THUS DONE AND SIGNED at ____________________________________________ on
this _____ day of _______________, 1998.
Witnessed: IMX PHARMACEUTICALS, INC.
_______________________________ By:________________________________________
___________________, its ______________,
_______________________________ he being duly authorized to do.
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