[REGIS TECHNOLOGIES, INC. LETTERHEAD]
February 28, 2003
Rostyk Mandzij
Immtech International, Inc.
150 Fairway Drive, Suite 150
Vernon Hills, IL 60061
Dear Rostyk:
Thank you for the opportunity to review your project, cGMP synthesis of DB289
using the new chemistry. Regis understands that Immtech is interested in
production of a batch of approximately 8 kg. Based on our recent R & D
activities on this chemistry, we offer the following proposal.
Price and Scope of Work
The price for cGMP production of approximately 8 kg DB289 is $198,500. We
understand that Regis will provide all raw materials. Activities will include:
1. Conducting scale-up experiments, as necessary;
2. Running a full-scale cGMP batch to produce approximately 8 kg of
product; and
3. Carrying out analytical testing on the final product, based on the
specifications previously established.
Documentation
Documentation for this batch will be carried out in a batch record. After
completion of the analytical testing on each intermediate and the final product,
a batch record package will be assembled, including the completed operating
procedure and all analytical data for raw materials and the product. A copy of
this package will be provided to Immtech and the original kept at Regis. In
addition, any related laboratory notebook pages can be provided upon request.
A Certificate of Analysis will accompany the product and include the results
from the assays established on July 31, 2000. Please advise if any changes have
been made since that date. Any other testing requirements or formal method
transfer may incur additional charges.
Regulatory
Regis operates in compliance with all applicable local, state and federal codes
and standards. The facility is considered to be a 90-day generator of hazardous
wastes. No waste treatment is performed on site: wastes are collected and
treated by a licensed waste disposal hauler. The primary disposition is fuel
reblending.
The FDA inspects Regis at least biennially. The most recent inspection took
place in October 2002. A copy of the FDA 483 and Regis' response is attached for
your review.
Communications
Your primary Regis contact for this work will be the author of this document,
Lori A. Hoffman. When work commences, weekly updates will be provided via phone,
fax, or e-mail, whichever the customer prefers. In addition, conference calls or
on-site meetings can be established to discuss progress and issues. Immtech
personnel are welcome on site at any time to observe the synthesis and audit the
facility.
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Qualifications
Until recently, Regis has primarily served as a source of preclinical and
clinical trial quantities of a wide range of bulk pharmaceutical intermediates
and ingredients. We are currently the commercial supplier of seven approved bulk
active pharmaceutical ingredients. Regis maintains an active contract with the
GMP Institute and GlobePharm providing ongoing cGMP training and internal
audits. Our facility and personnel are prepared for a preapproval inspection.
Please note that as contractor, Regis maintains the sole responsibility for
providing, approving and retaining key personnel for this project. Immtech will
be informed of any changes that may impact the project.
Technology Ownership and Documentation
Immtech will own all technology developed during the course of the work. Upon
completion of each chemical step, a batch record package will be assembled,
including the completed production log (either lab notebook pages or a batch
record) and all analytical data for raw materials and the product of that step.
A copy of this document will be provided to Immtech and the original kept at
Regis.
Delivery
Several raw materials have a 2-3 week lead time. The 4-bromobenzonitrile,
however, has a 6-7 week lead time. Another source can offer the material with a
4-6 week lead time, but the price for the project would increase to $212,400.
Please advise if this option is appealing. We will provide estimated timing upon
issuance of a purchase order and firmer scheduling as the materials arrive. Once
work commences, we anticipate production to require approximately 7-8 weeks to
complete. Weekly updates will keep Immtech up-to-date as to the progress of the
project.
Terms and Conditions
Regis will require a down payment of $40,000 to initiate work. The remainder,
$158,500, will invoice upon completion of the batch record package and/or
shipment of product. Prices are FOB Morton Grove, IL. Shipping charges are
prepaid and added to the invoice. Payment is due 30 days after receipt of
invoice. The customer's QA review of documentation should be completed within
that 30-day timeframe.
Please contact me if you have any questions or concerns about this proposal. To
indicate acceptance, please sign and date this letter and return a copy to me by
fax, along with any purchase order information. We look forward to working with
Immtech again on this project.
Best regards,
Lori A. Hoffman
Senior Project Manager
ACCEPTED BY:
/s/ T. Stephen Thompson President and CEO March 4, 2003
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Signature Title Date
_________________________
Purchase Order Number
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