[Confidential Treatment Requested. Confidential Portions of This Agreement have
been Redacted and have been separately filed with the Commission]
Exhibit 10.11
AMENDMENT NO. 2 TO LICENSE AND COLLABORATION AGREEMENT
THIS AMENDMENT NO. 2 TO LICENSE AND COLLABORATION AGREEMENT (this "Amendment"),
effective as of May 8, 2001 (the "Effective Date") is entered into by and
between THE IMMUNE RESPONSE CORPORATION, a Delaware corporation ("IRC"), and
TRINITY MEDICAL GROUP USA, INC., a Florida corporation ("Trinity"), with respect
to the following facts.
RECITALS
A. IRC and Trinity Medical Group, Co., Ltd., a Thai limited company
("Trinity Thailand"), entered into the License and Collaboration Agreement dated
as of September 15, 1995, which was amended on September 29, 2000, by the
Amendment No. 1 to License and Collaboration Agreement (the "Amendment No. 1")
(collectively the "Agreement").
B. Pursuant to the Assignment Agreement dated as of August 3, 0000,
xxxxxxx Xxxxxxx Xxxxxxxx and Trinity, Trinity Thailand assigned to Trinity and
Trinity assumed, all of Trinity Thailand's rights and obligations under the
Agreement.
C. The parties now desire to amend the Agreement on the terms and
conditions set forth below.
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual covenants set forth below, the parties amend the Agreement and otherwise
agree as follows:
ARTICLE 1
AMENDMENT
1.1 Section 1.8 of the Agreement shall be deleted in its entirety and
restated to read as follows:
"Manufacturing Cost" shall mean the fully-burdened
cost, expressed on a per unit manufacturing basis, of
manufacturing the Product, together with the packaging
thereof, including the cost of materials, direct labor and
benefits, overhead, all as determined in accordance with
generally accepted accounting principles ("GAAP"), and excess
capacity related cost, consistent with the manufacturer's
accounting practices for other products manufactured.
Materials, direct labor and benefits, overhead, and excess
capacity related cost shall be further defined as follows:
1.8.1 "Materials" shall include those items
which form an integral and direct part of the bulk
form of the Product and are necessary for its
production, as well as cartons, labels, package
inserts and shippers.
1.8.2 "Direct Labor and Benefits" shall
include that portion of basic wages, labor and
related payroll taxes and employee benefits spent in
actual production of the particular Product which can
be identified with or charged to the Product.
1.8.3 "Overhead" shall include without
limitation all operating expenses incurred by and in
support of the particular manufacturing cost centers,
purchasing department and quality assurance
operations, with respect to the Product, including
without limitation the following:
- Indirect labor, related payroll taxes and
employee benefits
- Depreciation
- Taxes
- Insurance
- Rent
- Repairs and maintenance
- Supplies
- Utilities
- Factory administrative expenses
1.8.4 "Excess Capacity Related Cost" shall
include any and all costs, as defined in Sections
1.8.1 - 1.8.3 above, that are associated with
underutilization of REMUNE(TM)plant capacity that may
otherwise be charged to expense in the period
incurred.
1.2 Section 1.18 shall be added to the Agreement as follows:
1.18 "Production" shall mean the actual production,
as determined at the end of each month, of IRC's current and
future manufacturing facility(s) which produces the Product.
1.3 Section 6.1.2 of the Agreement shall be deleted in its entirety and
restated to read as follows:
For Commercial Sale and Distribution. IRC shall
manufacture, sell and deliver to Trinity such amounts of the
Product, as Trinity reasonably requests pursuant to the
provisions of Section 6.4 below, equal to Trinity's
requirement of the Product for commercial sale and
distribution in the Territory for use in the Field, up to
twenty-five percent (25%) of IRC's Production for the Product.
In the event Trinity's requirement of the Product for
commercial sale and distribution in the Territory for use in
the Field exceeds twenty-five percent (25%) of IRC's
Production for the Product, Trinity may request such
additional amounts of the Product pursuant to the provisions
of Section 6.4 below, and IRC, in its sole discretion, may
decide to manufacture, sell and deliver to Trinity such
additional amounts of the Product.
1.4 Sections 6.3.1(a), (c) and (d) of the Agreement shall be deleted in
their entirety and restated to read as follows:
(a) With respect to clinical development supply under
Section 6.1.1 above, after receipt of approval from the
governing health authority of Thailand to conduct the
applicable human clinical trials in Thailand and approval from
the FDA to supply the Product for use therein, IRC shall
supply Trinity with such 100 microgram and DTH skin testing
doses of the Product and placebo (as set forth in mutually
acceptable protocols), for use in human clinical trials in
Thailand under the Development Program for a period not to
exceed three (3) years after the commencement of human
clinical trials in Thailand. IRC shall supply such doses of
Product and placebo for use in such human clinical trials in
Thailand for not more than 10,000 enrolled patients during
such period at no cost to Trinity. If additional Product and
placebo is required for use in human clinical trials in
Thailand prior to the First Commercial Sale, IRC shall supply
such additional Product and placebo as the parties mutually
agree in writing, at a purchase price equal to *** percent
(***%) of IRC's Manufacturing Cost for the Product and at such
purchase price as the parties mutually agree in writing for
placebo.
(c) With respect to commercial supply under Section
6.1.2 above, Trinity shall purchase Product from IRC at a
price equal to *** percent (***%) of IRC's Manufacturing Cost
for such Product.
(d) IRC shall calculate its Manufacturing Cost for
the Product in good faith in a manner which reasonably and
equitably allocates the cost of Materials, Direct Labor and
Benefits, Overhead, and Excess Capacity Related Cost (each as
defined in Section 1.8 above) to the Product.
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1.5 Article 7 of the Agreement shall be deleted in its entirety.
1.6 Article 8 of the Agreement shall be deleted in its entirety and
restated to read as follows:
ARTICLE 8
REPORTS AND ACCOUNTING
8.1 Reports, Exchange Rates. During the term of the
Agreement following the First Commercial Sale of the Product,
Trinity shall furnish to IRC a quarterly written report
showing in reasonably specific detail, on a country by country
basis, (a) the quantity of all Product sold or distributed by
Trinity, its Affiliates and its sublicensees in the Territory
during the reporting period; (b) the withholding taxes, if
any, required by law with respect to such sale or
distribution; and (c) the date of the First Commercial Sale of
the Product in each country in the Territory during the
reporting period. Reports shall be due on the thirtieth (30th)
day following the close of each quarter. Trinity shall keep
complete and accurate records in sufficient detail to properly
reflect all sales and distributions of the Product.
8.2 Audits for IRC
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8.2.1 Upon the written request of IRC and
not more than twice in each calendar year, Trinity
shall permit an independent certified public
accounting firm of internationally recognized
standing, selected by IRC and reasonably acceptable
to Trinity, at IRC's expense, to have access during
normal business hours to such records of Trinity as
may be reasonably necessary to verify the accuracy of
the reports hereunder for any year ending not more
than thirty-six (36) months prior to the date of such
request. The accounting firm shall disclose to IRC
only whether the records are correct or not and the
specific details concerning any discrepancies. No
other information shall be shared.
8.2.2 Trinity shall include in each
permitted sublicense granted by it pursuant to the
Agreement a provision requiring the sublicensee to
make reports to Trinity, to keep and maintain records
of sales and distributions made pursuant to such
sublicense and to grant access to such records by
IRC's independent accountant to the same extent
required of Trinity under the Agreement.
8.3 Audits for Trinity
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8.3.1 Upon the written request of Trinity
and not more than twice in each calendar year, IRC
shall permit an independent certified public
accounting firm of internationally recognized
standing, selected by Trinity and reasonably
acceptable to IRC, at Trinity's expense, to have
access during normal business hours to such records
of IRC as may be reasonably necessary to verify the
accuracy and the propriety of the amounts charged,
consistent with Manufacturing Cost, of any invoices
hereunder for any year ending not more than
thirty-six (36) months prior to the date of such
request. Trinity shall also have access to such
records of IRC, under the same terms and conditions
as provided for the audit of IRC's invoices to
Trinity, as may be reasonably necessary to verify
IRC's Production. The accounting firm shall disclose
to Trinity only whether the records are correct or
not and the specific details concerning any
discrepancies. No other information shall be shared.
8.4 Confidential Financial Information. Each party
shall treat all of the other party's financial information
subject to review under this Article 8 or under any sublicense
agreement as confidential, and shall cause its accounting firm
to retain all such financial information in confidence.
1.6 Sections 9.1, 9.3, and 9.5 shall be deleted in its entirety.
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1.7 Section 11.2 of the Agreement shall be deleted in its entirety and
restated to read as follows:
Termination by IRC. This Agreement shall terminate,
at the option of IRC effective upon written notice thereof to
Trinity, if Trinity has not received the required marketing
approval from the governing health authority of Thailand for
the Product on or before August 31, 2004.
ARTICLE 2
MISCELLANEOUS
2.1 Defined Terms. All terms used, but not defined, in this Amendment
shall have the respective meanings set forth in the Agreement.
2.2 Continuing Effect. This Amendment shall be effective for all
purposes as of the Effective Date. Except as otherwise expressly modified by
this Amendment, the Agreement shall remain in full force and effect in
accordance with its terms.
2.3 Governing Law. This Amendment shall be governed by and construed in
accordance with the laws of the State of California, without regard to the
conflicts of law, principles thereof, and shall not be governed by the United
Nations Convention on Contracts for the International Sale of Goods.
2.4 Counterparts. This Amendment may be executed in counterparts, each
of which shall be deemed to be an original and together shall be deemed to be
one and the same document.
IN WITNESS WHEREOF, the undersigned have duly executed and delivered
this Amendment effective as of the Effective Date.
THE IMMUNE RESPONSE CORPORATION
By /s/ Xxxxxx X. Xxxxx
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Xxxxxx X. Xxxxx, Ph. D.
President and Chief Executive Officer
TRINITY MEDICAL GROUP USA, INC.
By /s/ Xxxx Xxxxxxxxxxxxxx
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Title Chairman of the Board of Directors
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By /s/ Xxxx Xxxxxxxxxxxxxx
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Title President
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*** Confidential Material redacted and filed separately.
