SUBLICENSE AND SUPPLY AGREEMENT
THIS SUBLICENSE AND SUPPLY AGREEMENT is dated as of August 4, 2000 and is
entered into between
TRINITY MEDICAL GROUP USA, INC. ("TMGUSA"), a Florida Corporation, having a
place of business at 3753 Howard Hughes Parkway, Las Vegas, NV 89109, U.S.A; and
TRINITY ASSETS COMPANY LIMITED ("TAC"), a company incorporated in Thailand,
having a place of business at 425/129 Soi Sirijulsawek, Silom Road, Bangkok
10500, Thailand.
WITNESSETH:
WHEREAS, THE IMMUNE RESPONSE CORPORATION (" IRC") and TRINITY MEDICAL GROUP
COMPANY LIMITED ("TMG") entered into the License and Collaboration Agreement
dated as of 15 September 1995 (the "License Agreement").
WHEREAS, TMG assigned all of its rights and obligations under the License
Agreement to TMGUSA pursuant to the terms and conditions of the Assignment
Agreement dated as of 3 August 2000 (the "Assignment Agreement").
WHEREAS, TMGUSA, Dr. Vina Churdboonchart and TMG entered into the Collaboration
and Supply Agreement dated as of 1 December 1999 (the "Collaboration and Supply
Agreement").
WHEREAS, TMGUSA and TAC hereby enter into this Sublicense and Supply Agreement
dated as of 4 August 2000 (the "Distribution and Supply Agreement").
WHEREAS, TMGUSA intends to sublicense some of its rights and obligations
assigned to it pursuant to the Assignment Agreement and supply the Product
purchased from IRC to TAC in accordance with the terms and conditions of this
Agreement.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants herein contained, the Parties agree as follows:
ARTICLE 1. DEFINITION AND INTERPRETATION
Unless otherwise specified in this Agreement, terms used in this Agreement shall
have the same meanings as provided in the License Agreement between TMG and The
Immune Response Corporation dated September 15, 1995.
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ARTICLE 2. DEVELOPMENT PROGRAM
2.1 Subcontract of the Development Program
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2.1.1 TMGUSA agrees to subcontract the Development Program to be
performed by it in the normal course of its business to TAC
and TAC shall perform the Development Program in compliance
with the terms and conditions as specified in the License
Agreement and shall be in compliance in all material respects
with all requirements of laws and regulations of the United
States and the applicable countries of the Territory, together
with all good laboratory practices and good clinical practices
of the United States and the applicable countries of the
Territory.
2.1.2 The subcontracting of the Development Program shall not
involve the transfer of Product Know-How to Third Parties
without the prior express written consent of IRC.
2.1.3 TMGUSA shall supervise the subcontract work.
2.2 Expenses of the Development Program
-----------------------------------
2.2.1 In performing the subcontract work of the Development Program
as specified in Article 2.1, TAC shall invoice TMGUSA
appropriate expenses associated with clinical trials until
full regulatory approval of the Product ("Remune") in Thailand
is granted.
2.2.2 Acceptable direct expenses and pay rates include:
a) Principal Investigator Time at US $250 per hour.
b) All travel expenses including air fare at First Class
rates, lodging and meals, including incidentals.
c) All telephone, fax, and document delivery charges
between TAC and TMGUSA, IRC, Thai Governmental
officials, Mahidol University personnel, clinical
trial collaborators, patients, publications, and
conferences.
d) Associate Researcher labor for clinical trial data
statistical analysis at US $125 per hour.
e) CD4 and viral load laboratory assays at US $50 per
hour labour or per test result, whichever is greater.
f) All other actual laboratory fees and cost of
necessary laboratory equipment purchases as may be
required in order to carry out the study in
accordance with internationally accepted standards.
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g) Rental and maintenance costs of an appropriate study
coordinating center including office, furniture,
computers and other data processing equipment
necessary at the study center or at the study test
sites.
2.2.3 Publication Expense Reimbursement
---------------------------------
h) TAC is to receive reimbursement from TMGUSA for
activities and expenses as per section 2.2.2 related
to each instance of publication of scientific results
of the Product in peer reviewed scientific journals.
Such reimbursement is to be made for all publications
submitted prior to full regulatory approval of the
Product in Thailand. Example publications include but
are not limited to the Journal of AIDS, Journal of
Human Virology, and the New England Journals of
Medicine.
i) TAC is to receive reimbursement for direct expenses
from TMGUSA as per section 2.2.2 for each oral
presentation of Product study results in front of an
international scientific conference where such
conference has more than 50 attendees from different
organizations. Such award is to be made for all
presentations submitted prior to full regulatory
approval of the Product in Thailand. Evidence of
presentation is a copy of the program that included
the presentation's abstract.
j) TAC is to receive reimbursement for direct expenses
from TMGUSA as per section 2.2.2 for each poster
presentation of Product study results in an
AIDS-related international scientific conference.
Such award is to be made for all presentations
submitted prior to full regulatory approval of the
Product in Thailand.
ARTICLE 3. SUBLICENSES
3.1 Sublicense Rights
-----------------
TMGUSA hereby grants to TAC an exclusive sublicense in the Territory
for the marketing, promoting, selling and distributing the Product.
This sublicense shall be subject to the provisions of the License
Agreement.
3.2 Rights to Market and Sell the Product in other countries other than
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Thailand
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In the event that TAC, TMGUSA or any of its Affiliates secures the
required marketing approval for the Product in a country in the
Territory (other than Thailand), the profits from the sale of Product
in such country shall be divided equally between TMGUSA, TAC or the
relevant Affiliate.
3.3 Supports for the Manufacturing and other related Facilities for the
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Marketing, Promoting, Selling and Distribution of the Product in
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Thailand
--------
TMGUSA agrees to provide support to TAC (in the form and substance
satisfactory to
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both parties) for the warehousing, transportation, production of any
related capital assets, plant equipment, land purchases or leases which
are necessary for the marketing, promoting, selling and distribution of
the Product in Thailand.
ARTICLE 4. PRODUCT SUPPLY
4.1 Purchase and Sale of Products
-----------------------------
TMGUSA agrees to sell the Product to TAC at the price equal to the
minimum of US $75 above the TMGUSA's cost of the Product for each [100
micrograms dose] purchased.
4.2 Adjustment of the Purchase Price
--------------------------------
If the Product is commercially sold or distributed in the Territory in
other than 100 microgram doses, the parties shall negotiate in good
faith a mutually acceptable adjustment to the purchase price.
4.3 Payment Terms
-------------
TMGUSA shall extend credit to TAC for the Product orders that are
consigned to distributor(s), provided that TAC is able to provide
sufficient cash at the time of delivery to cover the cost of the
Product (including cost of goods from the manufacturer, shipping and
direct expenses).
TAC shall pay the remaining balance within 90 days after the shipment
of the Product.
ARTICLE 5. CONFIDENTIALITY
5.1 Nondisclosure Obligations
-------------------------
Except as otherwise provided in this Article 5, during the term of the
Agreement and for a period of five (5) years thereafter, TAC shall
maintain in confidence and use only for purposes of the Agreement all
information and data, of any type whatsoever, (a) disclosed by IRC
and/or TMGUSA and identified as, or acknowledged to be, confidential,
or (b) resulting from the Development Program or relating to the
Product (the "Confidential Information").
5.2 Permitted Disclosures
---------------------
To the extent it is reasonably necessary or appropriate to fulfill its
obligations under this Agreement, TAC may disclose (a) Confidential
Information it is otherwise obligated under this Article 5 not to
disclose to its employees, directors, officers or any other persons
related to the Development Program on a need-to-know basis on the
condition that such persons agree in writing, or are subject to a
written Institution policy, to keep the Confidential Information
confidential for the same time periods and to the same extent as TAC is
required to keep the Confidential Information confidential and (b)
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Confidential Information to governmental or other regulatory
authorities to the extent that such disclosure is required by
applicable law, regulation or court order, provided that TAC shall, to
the extent practicable, give advance written notice to TMGUSA thereof
and sufficient opportunity to object to such disclosure or to request
upon discover of any unauthorized use or disclosure of the Confidential
Information.
The obligation not to disclose or use Confidential Information shall
not apply to the extent that TAC can demonstrate that (i) the disclosed
information was public knowledge at the time of such disclosure by TAC,
or thereafter became public knowledge, other than as a result of
actions of TAC, its directors, officers, employees or any other persons
related to the Development Program, in violation hereof, (ii) the
disclosed information was rightfully known by TAC or its affiliates (as
shown by its written records) prior to the date of disclosure to TAC
hereunder; or (iii) the disclosed information was disclosed to TAC or
its affiliates on an unrestricted basis from a source unrelated to any
party to the Agreement and not under a duty of confidentiality to IRC
or TMGUSA.
5.3 Publication
------------
Subject to the provisions of Sections 5.1 and 5.2 above, TAC shall have
the right to publish the results of the Development Program; provided,
however, that TAC shall provide TMGUSA and IRC the opportunity to
review any proposed manuscripts or any other proposed disclosure
describing such results not less than sixty (60) days prior to their
proposed submission for publication or other proposed disclosure.
TMGUSA or IRC shall have the right to require the delay of any such
publication or disclosure for a period of up to ninety (90) days to
permit to prepare and file such patent applications as it believes are
necessary or desirable to protect any patentable subject matter to be
disclosed in such publication or other disclosure. TMGUSA or IRC shall
also have the right to require the delay of any such publication or
disclosure until such time as TMGUSA or IRC has filed such results with
the FDA.
5.4 Terms and Conditions of the Agreement
-------------------------------------
TAC and TMGUSA shall not disclose any terms or conditions of the
Agreement to any Third Party without the prior consent of the other
parry, except as required by applicable law or to Persons with whom TAC
or TMGUSA has entered into or proposes to enter into a business
relationship, provided that such Persons shall enter into the required
confidentiality agreement.
ARTICLE 6. MISCELLANEOUS
6.1 Notices
--------
Any consent, notice or report required or permitted to be given or made
under the Agreement by a party to the other shall be in writing,
delivered personally or by facsimile (and promptly confirmed by
personal delivery, air mail or internationally-recognized courier) air
mail or internationally-recognized courier, postage prepaid (where
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applicable), addressed to the other party at its address indicated
furnished in writing to the addressor and (except as otherwise provided
in the Agreement) shall be effective upon receipt by the addressee.
If to TMGUSA: Trinity Medical Group USA, Inc.
3753 Howard Hughes Parkway
Las Vegas, NV 89109
U. S. A.
Attention: Mr. James S. Namnarth, Ph.D.
Chief Operating Officer
If to TAC: Trinity Assets Company Limited
425/l29 Soi Sirijulsawek
Silom Road
Bangkok 10500, Thailand
Attention: Mr. Inthanom Churdboonchart
Director
6.2 Applicable Law
---------------
This Agreement shall be governed by and construed in accordance with
the laws of the United States and the State of Nevada.
6.3 Entire Agreement
-----------------
The Agreement between TMGUSA and TAC, together with their respective
exhibits, contain the entire understanding of the parties with respect
to the subject matter hereof. All express or implied agreements and
understandings, either oral or written, heretofore made are expressly
superseded by the Agreement. This Agreement may be amended, or any term
hereof modified, only by a written instrument duly executed by both
parties.
6.4 Headings
---------
The captions to the several Articles and Sections hereof are not a part
of the Agreement, but are merely guides or labels to assist in locating
and reading the several Articles and Sections of this Agreement.
6.5 Independent Contractors
-----------------------
It is expressly agreed that TMGUSA and TAC shall be independent
contractors and that the relationship between the two parties shall not
constitute a partnership, joint venture or agency. Neither TMGUSA nor
TAC shall have the authority to make any statements, representations or
commitments of any kind, or to take any action, which shall be binding
on the other, without the prior consent of the other party to do so.
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6.6 Waiver
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The waiver by either party of any right hereunder or the failure to
perform or of a breach by the other party shall not be deemed a waiver
of any other right hereunder or of any other breach or failure by said
other party whether of a similar nature or otherwise.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the date set
forth above.
For and on behalf of TRINITY MEDICAL GROUP USA, INC.
By:
/s/ Vina Churdboonchart /s/ James Namnath
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For and on behalf of
TRINITY ASSETS COMPANY LIMITED
By:
/s/ Inthanom Churdboonchart /s/ Orranart Churdboonchart
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