THIS AGREEMENT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED ON PAGES 7, 9, 13 AND 14,
AND PORTIONS OF ATTACHMENTS 1 AND 5 AND HAS BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
LICENSE AGREEMENT
BETWEEN
APOLLON, INC.
AND
THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
1 DECEMBER 1994
TABLE OF CONTENTS
RECITALS................................................................... 1
ARTICLE 1 - DEFINITIONS.................................................... 2
ARTICLE 2 - LICENSE GRANT.................................................. 5
ARTICLE 3 - FEES AND ROYALTIES............................................. 6
ARTICLE 4 - CONFIDENTIALITY................................................ 11
ARTICLE 5 - TERM AND TERMINATION........................................... 12
ARTICLE 6 - PATENT MAINTENANCE AND REIMBURSEMENT........................... 13
ARTICLE 7 - INFRINGEMENT AND LITIGATION.................................... 14
ARTICLE 8 - DISCLAIMER OF WARRANTY; INDEMNIFICATION........................ 15
ARTICLE 9 - USE OF PENN'S NAME............................................. 17
ARTICLE 10 - ADDITIONAL PROVISIONS......................................... 18
Attachment 1
Attachment 2
Attachment 3
Attachment 4
Attachment 5
i
LICENSE AGREEMENT
This License Agreement ("AGREEMENT") is made by and between The Trustees
of the University of Pennsylvania, a Pennsylvania nonprofit corporation, with
offices located at 0000 Xxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxxxxxx, Xxxxxxxxxxxx
00000-0000 ("PENN") and Apollon, Inc., a corporation organized and existing
under the laws of Pennsylvania, having a place of business at Xxx Xxxxx Xxxxxx
Xxxxxxx, Xxxxxxx, Xxxxxxxxxxxx 00000-0000 ("APOLLON").
This AGREEMENT is effective as of 1 December 1994 ("EFFECTIVE DATE").
RECITALS
WHEREAS, PENN and The Wistar Institute of Anatomy and Biology ("WISTAR")
own and are proprietors of certain intellectual properties developed by Xx.
Xxxxxxx X. Xxxxxxxx of PENN's School of Medicine and/or by Xx. Xxxxx X. Xxxxxx
of PENN's School of Medicine and WISTAR (through 31 June 1993) and of PENN only
(as of 1 July 1993) and/or by other inventors with a duty to assign to PENN or
WISTAR relating to genetic vaccines, i.e., facilitated transfer and expression
of nucleic acids;
WHEREAS, PENN and WISTAR own applications for United States letters
patent listed in Attachment 1 attached hereto and foreign counterparts
relating to the foregoing intellectual property developed by Xx. Xxxxxxxx
and/or Xx. Xxxxxx et al.;
WHEREAS, the Institute of Biotechnology and Advanced Molecular Medicine,
Inc. ("IBAMM"), an industry-driven initiative of the Technology Council of
Greater Philadelphia, has funded certain research of Drs. Xxxxxxxx and Xxxxxx
pursuant to the terms of a sponsored research agreement effective as of 1 July
1992 ("IBAMM SPONSORED RESEARCH AGREEMENT"; Attachment 2);
WHEREAS, APOLLON has secured from IBAMM the exclusive right to negotiate
to acquire a license to use, develope, manufacture, market and exploit the
intellectual property developed by Xx. Xxxxxxxx and/or Xx. Xxxxxx et al. under
the IBAMM SPONSORED RESEARCH AGREEMENT and described in Attachment 1 hereto
pursuant to the terms of a license agreement effective as of 1 December 1994
("IBAMM/APOLLON AGREEMENT"; Attachment 3);
WHEREAS, APOLLON is funding further research at PENN by Xx. Xxxxxxxx and
Xx. Xxxxxx relating to certain nucleic acid constructs and their introduction
into mammalian cells pursuant to the terms of a sponsored research agreement
effective as of 1 July 1993 ("SPONSORED RESEARCH AGREEMENT"; Attachment 4);
1
License Agreement (I)--Apollon/Penn
2 December 1994 Version
WHEREAS, APOLLON desires to secure the exclusive right and license to use,
develop, manufacture, market and exploit the intellectual property developed by
Xx. Xxxxxxxx and/or Xx. Xxxxxx et al. under the IBAMM SPONSORED RESEARCH
AGREEMENT and the SPONSORED RESEARCH AGREEMENT and described in Attachment 1
hereto; and
WHEREAS, PENN has determined that the exploitation of the intellectual
property developed by Xx. Xxxxxxxx and/or Xx. Xxxxxx et al. is in the best
interest of PENN and is consistent with its educational and research missions
and goals.
NOW, THEREFORE, in consideration of the premises and of the promises and
covenants contained herein and intending to be legally bound hereby, the
parties agree as follows:
ARTICLE 1. DEFINITIONS
1.1 AFFILIATE means, when used with reference to APOLLON, any ENTITY
directly or indirectly controlling, controlled by or under common control with
APOLLON. For purposes of this AGREEMENT, "control" means the direct or indirect
ownership of at least fifty percent (50%) of the outstanding voting securities
of an ENTITY, or the right to receive at least fifty percent (50%) of the
profits or earnings of an ENTITY, or having at least fifty percent (50%)
control of the policy decisions of a ENTITY.
1.2 APOLLON shall include APOLLON and its AFFILIATES.
1.3 BANKRUPTCY EVENT means the ENTITY in question becomes insolvent, or
voluntary or involuntary proceedings by or against such ENTITY are instituted
in bankruptcy or under any insolvency law, or a receiver or custodian is
appointed for such ENTITY, or proceedings are instituted by or against such
ENTITY for corporate reorganization or the dissolution of such ENTITY, which
proceedings, if involuntary, shall not have been dismissed within sixty (60)
days after the date of filing, or such ENTITY makes an assignment for the
benefit of creditors, or substantially all of the assets of such ENTITY are
seized or attached and not released within sixty (60) days thereafter.
1.4 CALENDAR QUARTER means each three-month period, or any portion
thereof, beginning on January 1, April 1, July 1 and October 1 of each year.
1.5 CALENDAR YEAR means a period of twelve (12) months beginning on
January 1 and ending on December 31.
1.6 CLAIM means a claim of an issued, unexpired patent that shall be
presumed to be valid and enforceable unless and until it
2
License Agreement (I)--Apollon/Penn
2 December 1994 Version
has been held to be invalid and/or unenforceable by a final judgement of a
court of competent jurisdiction from which no appeal can be or is taken.
1.7 CONFIDENTIAL INFORMATION means and includes all technical
information, inventions, developments, discoveries, software, know-how,
methods, techniques, formulae, data, processes and other proprietary ideas,
whether or not patentable or copyrightable, that PENN identifies as
confidential or proprietary at the time it is delivered or communicated to
APOLLON.
1.8 DRUG means an article, intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or other animals; or an
article intended to affect the structure or any function of the body of man or
other animals that requires FDA approval as a drug.
1.9 ENTITY means a corporation, an association, a joint venture, a
partnership, a trust, a business, an individual, a government or political
subdivision thereof, including an agency, or any other organization that can
exercise independent legal standing.
1.10 FDA means the Food and Drug Administration of the United States.
1.11 FEDERAL GOVERNMENT INTEREST means the rights of the United States
Government under Public Laws 96-517, 97-256 and 98-620, codified at 35 U.S.C.
200-212, and any regulations issued thereunder, as statute or regulations may
be amended from time to time hereafter.
1.12 FAIR MARKET VALUE means the cash consideration which APOLLON or its
SUBLICENSEE would realize from an unaffiliated, unrelated buyer in an arm's
length sale of an identical item sold in the same quantity and at the same time
and place of the transaction.
1.13 IN REASONABLE COMPETITION WITH SUCH PENN LICENSED PRODUCT means that
it is demonstrated to PENN's reasonable satisfaction that: (a) a competitor's
product is sold in the same geographic and relevant product market as such PENN
LICENSED PRODUCT; and such competitor's product has a unit sales volume that
exceeds twenty-five percent (25%) of APOLLON's unit sales volume for such PENN
LICENSED PRODUCT in such geographic market; or (b) two or more competitors's
product(s) are sold in the same geographic and relevant product market as such
PENN LICENSED PRODUCT; and such competitors's product(s) together have a unit
sales volume that exceeds thirty-five percent (35%) of APOLLON's
3
License Agreement (I)--Apollon/Penn
2 December 1994 version
unit sales volume for such PENN LICENSED PRODUCT in such geographic market.
1.14 JOINT PATENT RIGHTS means those United States patent applications
and foreign counterparts including continuation, divisional and reissue
applications thereof and continuation-in-part applications thereof based upon
intellectual property discovered by PENN through Xx. Xxxxxxxx and/or Xx. Xxxxxx
and/or other inventors with a duty to assign to PENN with one or more inventors
of APOLLON, as a result of the SPONSORED RESEARCH AGREEMENTS between PENN and
APOLLON, together with any and all patents issuing thereupon and reissues,
re-examination and extensions thereof.
1.15 NET SALES means the cash consideration or, if not a cash
transaction, FAIR MARKET VALUE attributable to the SALE of any PENN LICENSED
PRODUCT(S), less qualifying costs directly attributable to such SALE and
actually identified on the invoice and borne by APOLLON or its SUBLICENSEE.
1.15.1 Such qualifying costs shall be limited to the following:
1.15.1.1 Discounts, in amounts customary in the trade, for
quantity purchases, prompt payments and for wholesalers and
distributors.
1.15.1.2 Credits or refunds, not exceeding the original invoice
amount, for claims or returns.
1.15.1.3 Prepaid transportation insurance premiums.
1.15.1.4 Prepaid outbound transportation expenses.
1.15.1.5 Sales and use taxes imposed by a governmental agency.
1.16 PENN LICENSED PRODUCT(S) means products which in the absence of this
AGREEMENT would infringe at least one CLAIM of PENN PATENT RIGHTS and/or JOINT
PATENT RIGHTS on a country-by-country basis, or products which are made using a
process or machine which in the absence of this AGREEMENT would infringe at
least one CLAIM of PENN PATENT RIGHTS and/or JOINT PATENT RIGHTS, or products
made, at least in part, using PENN TECHNICAL INFORMATION.
1.17 PENN PATENT RIGHTS means those United States patent applications
listed in Attachment 1 hereto, as may be amended from time to time in
accordance with the SPONSORED RESEARCH
4
License Agreement (I)--Apollon/Penn
2 December 1994 version
AGREEMENT, and foreign counterparts including continuation, divisional and
re-issue applications thereof and continuation-in-part applications thereof
based upon intellectual property discovered by PENN through Xx. Xxxxxxxx
and/or Xx. Xxxxxx and/or other inventors with a duty to assign to PENN as a
result of the SPONSORED RESEARCH AGREEMENT between PENN and APOLLON together
with any and all patents issuing thereupon.
1.18 PENN TECHNICAL INFORMATION means research and development
information, unpatented inventions, know-how, and technical data directly
related to PENN PATENT RIGHTS in the possession of PENN on the EFFECTIVE DATE
of this AGREEMENT or developed in the conduct of the SPONSORED RESEARCH
AGREEMENT which is needed to produce PENN LICENSED PRODUCTS.
1.19 SALE means any bona fide transaction for which consideration is
received or expected for the sale, use, lease, transfer or other disposition of
PENN LICENSED PRODUCT(S). A SALE of PENN LICENSED PRODUCT(S) shall be deemed
completed at the time APOLLON or its SUBLICENSEE invoices, ships, or receives
payment for such PENN LICENSED PRODUCT(S), whichever occurs first.
1.20 SUBLICENSEE shall mean any corporation, company, partnership, or
business entity which neither controls, nor is controlled by, nor is under
common control with APOLLON, to which APOLLON transfers by sublicense rights to
enable said party to make and sell PENN LICENSED PRODUCTS.
ARTICLE 2. LICENSE GRANT
2.1 PENN grants to APOLLON for the term of this AGREEMENT an exclusive,
world-wide right and license, with the right to grant sublicenses, to make,
have made, use, sell, and have sold including the right to sell for resale PENN
LICENSED PRODUCT(S); provided however, that the license to any PENN LICENSED
PRODUCT that incorporates, in whole or in part, the PENN PATENT RIGHTS owned
jointly with WISTAR shall be exclusive only to PENN's undivided interest in
them. No other rights or licenses are granted hereunder. Intellectual property
created or conceived during the performance of the SPONSORED RESEARCH AGREEMENT
shall be governed by the SPONSORED RESEARCH AGREEMENT.
2.2 Except as limited in Section 2.1, the license grant of this ARTICLE 2
is exclusive but for the reserved right of PENN to use and permit other
nonprofit organizations to use the PENN PATENT RIGHTS, the JOINT PATENT RIGHTS,
and the PENN TECHNICAL INFORMATION without cost for educational and research
purposes only.
5
License Agreement (I)--Apollon/Penn
2 December 1994 version
2.3 APOLLON acknowledges that in accordance with the FEDERAL GOVERNMENT
INTEREST, the United States government retains certain rights in intellectual
property funded in whole or part under any contract, grant or similar agreement
with a Federal agency. The license grant of this ARTICLE 2 is expressly subject
to all of such rights, if applicable. PENN agrees to follow the applicable
procedures to elect to retain title to intellectual property, subject to the
requirements of the laws and regulations referred to in Section 1.11.
2.4 The right to sublicense conferred upon APOLLON under this AGREEMENT
is subject to the following conditions:
2.4.1 In each such sublicense, the SUBLICENSEE shall be prohibited
from further sublicensing and shall be subject to the terms and conditions of
the license granted to APOLLON under this AGREEMENT.
2.4.2 APOLLON shall forward in confidence to PENN, within thirty
(30) days of execution, a complete and accurate copy written in the English
language of each sublicense granted hereunder. PENN's receipt of such
sublicense shall not constitute an approval of such sublicense or a waiver of
any of PENN's rights or APOLLON's obligations hereunder.
2.4.3 If APOLLON becomes subject to a BANKRUPTCY EVENT, all payments
then or thereafter due and owing to APOLLON from its SUBLICENSEES shall upon
notice from PENN to any such SUBLICENSEE become payable directly to PENN for
the account of APOLLON; provided, however, that PENN shall remit to APOLLON the
amount by which such payments exceed the amounts owed by APOLLON to PENN.
2.4.4 Notwithstanding any such sublicense, APOLLON shall remain
primarily liable to PENN for all of APOLLON'S duties and obligations contained
in this AGREEMENT, and any act or omission of a SUBLICENSEE which would be a
breach of this AGREEMENT if performed by APOLLON shall be deemed to be a breach
by APOLLON of this AGREEMENT, provided that APOLLON shall be given the
opportunity to cure such breach as permitted under Section 5.3.4 hereof.
2.4.5 In the event that during the term of this AGREEMENT, PENN
acquires title to any patent or patent application that PENN is advised may be
infringed by APOLLON's exercise of its license under this AGREEMENT, PENN
agrees to advise APOLLON and discuss APOLLON's exercise of its license
hereunder under such circumstances. Notwithstanding the foregoing, however,
this Section 2.4.5 shall not be construed to grant any rights or licenses to
APOLLON other than those granted under Section 2.1, and PENN makes no
representations regarding
6
License Agreement (I)--Apollon/Penn
2 December 1994 version
patents and patent applications to which third parties may acquire license or
option rights as a result of sponsored research or license agreements such
parties may enter into with PENN.
ARTICLE 3. FEES AND ROYALTIES
3.1 LICENSE INITIATION FEE AND ROYALTIES
3.1.1 In partial consideration of the exclusive license granted
herein, APOLLON shall pay to PENN on the EFFECTIVE DATE of this AGREEMENT, a
non-refundable license initiation fee of [
].
3.1.2 In further consideration of the exclusive license granted
herein, APOLLON shall pay to PENN a royalty on NET SALES of PENN LICENSED
PRODUCTS as follows:
3.1.2.1 [ ] in countries where the PENN
LICENSED PRODUCTS are covered by a CLAIM of an issued patent of PENN PATENT
RIGHTS or JOINT PATENT RIGHTS; or
3.1.2.2 [ ] in countries where the
PENN LICENSED PRODUCTS are not covered by a CLAIM of an issued patent of PENN
PATENT RIGHTS or JOINT PATENT RIGHTS.
3.1.3 The payment of royalties to PENN on any particular PENN
LICENSED PRODUCT shall terminate in each country on (a) the expiration date of
the last-to-expire issued patent from the PENN PATENT RIGHTS or JOINT PATENT
RIGHTS covering such product, or (b) with respect to a PENN LICENSED PRODUCT on
which there has not ever been any patents issued pertaining to PENN PATENT
RIGHTS or JOINT PATENT RIGHTS in such country, on the earlier to occur of the
following: (i) the date on which APOLLON demonstrates to PENN's reasonable
satisfaction that a third party is selling a product in the relevant country IN
REASONABLE COMPETITION WITH SUCH PENN LICENSED PRODUCT; or (ii) ten (10) years
from the first commercial sale in such country. In the event a patent covering
such product issues subsequent to termination of payment of royalties to PENN
pursuant to Section 3.1.3.(b), then payment of royalties to PENN shall resume
pursuant to Section 3.1.2.1 until terminated pursuant to Section 3.1.3.(a).
3.1.4 APOLLON shall promptly pay to PENN [ ]
of any sublicense initiation fee or other such consideration paid by each
SUBLICENSEE of this AGREEMENT. Any non-cash consideration, except consideration
directly related to development or marketing of PENN LICENSED PRODUCTS,
received by
7
License Agreement (I)--Apollon/Penn
2 December 1994 version
the APOLLON from such SUBLICENSEES shall be valued at its FAIR MARKET VALUE
as of the date of receipt.
3.1.5 NET SALES of any PENN LICENSED PRODUCT shall not be subject to
more than one assessment of the scheduled royalty; such assessment shall be the
highest applicable royalty.
3.1.6 In the event that a PENN LICENSED PRODUCT is sold in the form
of a combination product containing one or more DRUGS which are themselves not
PENN LICENSED PRODUCTS, the NET SALES shall be calculated by multiplying the
sales price of such combination product by the fraction A/(A+B) where A is the
invoice price or FAIR MARKET VALUE of the PENN LICENSED PRODUCT and B is the
total invoice price or FAIR MARKET VALUE of the other DRUGS. In the case of a
combination product which includes one or more PENN LICENSED PRODUCTS, the NET
SALES upon which the royalty due PENN is based shall not be less than the
normal aggregate NET SALES for such PENN LICENSED PRODUCTS.
3.1.7 No royalties shall be due on PENN LICENSED PRODUCTS used for
clinical trials or studies which are carried out in order to obtain
governmental marketing approvals or for marketing efforts including the
distribution of a reasonable number of samples for promotional purposes,
unless such clinical trials or studies are Phase III or Phase IV and the PENN
LICENSED PRODUCTS are sold at a profit.
3.1.8 In the event APOLLON is required to obtain a license under
patent rights of a third party in order to exercise its rights under this
AGREEMENT, APOLLON and PENN agree to meet and discuss the royalties due under
this ARTICLE 3 and, if appropriate, to negotiate in good faith.
3.1.9 In the event a PENN LICENSED PRODUCT is covered only by a
CLAIM of JOINT PATENT RIGHTS, PENN and APOLLON agree to meet to discuss the
royalties due under this ARTICLE 3 and if appropriate, to negotiate in good
faith taking into consideration the relative contributions of the parties.
3.2 MILESTONES AND MAINTENANCE FEES
3.2.1 APOLLON shall use its best efforts to develop for commercial
use and to market PENN LICENSED PRODUCTS as soon as practical, consistent with
sound and reasonable business practices. Attachment 3 lists mutually agreed
upon performance milestones and research and development milestones.
3.2.2 APOLLON shall provide PENN on each June 1 and December 1 with
written reports, setting forth in such detail as PENN may reasonably request,
the progress of the development, evaluation, testing and commercialization of
the PENN LICENSED
8
License Agreement (I)--Apollon/Penn
2 December 1994 version
PRODUCTS under development. APOLLON shall also notify PENN within thirty
(30) days of the first commercial sale of any PENN LICENSED PRODUCT.
3.2.3 APOLLON shall pay to PENN an annual license maintenance fee of
[ ] due and payable on the anniversary of the
EFFECTIVE DATE until minimum royalties are due; provided, however, that after
the date of first commercial sale of PENN LICENSED PRODUCT no further license
maintenance fee shall become due and payable.
3.3 MINIMUM ROYALTIES
3.3.1 APOLLON shall pay to PENN a non-refundable minimum royalty for
each PENN LICENSED PRODUCT sold for the following periods in the corresponding
amounts:
Period Due Date Minimum Royalty
[
]
3.3.2 A minimum royalty payment paid under Section 3.3.1 herein shall
serve as an advanced payment against royalties due under Section 3.1 herein
during the period for which such minimum royalty payment was paid.
3.4 REPORTS AND RECORDS
3.4.1 Upon first commercial sale of a PENN LICENSED PRODUCT, APOLLON
shall deliver to PENN one copy each within forty-five (45) days after the end
of each CALENDAR QUARTER a report, certified by the chief financial officer of
APOLLON setting forth in reasonable detail the calculation of the royalties due
to PENN for such CALENDAR QUARTER, including, without limitation:
9
License Agreement (I)--Apollon/Penn
2 December 1994 version
3.4.1.1 Number of PENN LICENSED PRODUCTS involved in SALES,
listed by country.
3.4.1.2 Gross consideration for SALES of PENN LICENSED
PRODUCTS, including all amounts invoiced, billed, or received.
3.4.1.3 Qualifying costs, as defined in Section 1.15, listed by
category of cost.
3.4.1.4 NET SALES of PENN LICENSED PRODUCTS listed by country.
3.4.1.5 Royalties owed to PENN, listed by category, including
without limitation earned, SUBLICENSEE-derived, and minimum
royalty categories.
3.4.1.6 Minimum royalty payments credited against earned
royalty payments.
3.4.2 Royalties payable under Sections 3.1 and 3.3 hereof shall be
paid within forty-five (45) days following the last day of the CALENDAR QUARTER
in which the royalties accrue and shall accompany the report of Section 3.4.1.
3.4.3 APOLLON will maintain and cause its SUBLICENSEES to maintain,
complete and accurate books and records which enable the royalties payable
hereunder to be verified. The records for each CALENDAR QUARTER shall be
maintained for three years after the submission of each report under ARTICLE 3
hereof. Upon reasonable prior notice to APOLLON and its SUBLICENSEES, APOLLON
agrees to permit such books and records to be examined by an independent
certified public accountant designated by PENN. The purpose of such audit shall
be solely for verifying the royalties due and payable per this AGREEMENT and
said accountant shall only disclose to PENN NET SALES and royalties due and
payable hereunder. Such access shall be available not more than once each
CALENDAR YEAR, during normal business hours, and for each of three years after
the expiration or termination of this AGREEMENT. If APOLLON has underpaid
royalties by 5% or more, APOLLON will pay the costs and expenses of said
accountants in connection with their review or audit.
3.5 CURRENCY, PLACE OF PAYMENT, INTEREST
3.5.1 All dollar amounts referred to in this AGREEMENT are expressed
in United States dollars. All payments to PENN under this AGREEMENT shall be
made in United States dollars by check payable to "The Trustees of the
University of Pennsylvania."
10
License Agreement (I)--Apollon/Penn
2 December 1994 version
3.5.2 If APOLLON receives revenues from SALES of PENN LICENSED
PRODUCTS in currency other than United States dollars, revenues shall be
converted into United States dollars at the conversion rate for the foreign
currency as published in the eastern edition of THE WALL STREET JOURNAL as of
the last business day of the applicable CALENDAR QUARTER.
3.5.3 Amounts that are not paid when due shall accrue
interest from the due date until paid, at a rate equal to one and one-half
percent (1.5%) per month (or the maximum allowed by law, if less).
ARTICLE 4. CONFIDENTIALITY
4.1 APOLLON agrees to maintain in confidence and not to disclose
to any third party any CONFIDENTIAL INFORMATION of PENN received pursuant to
this AGREEMENT. APOLLON agrees to ensure that its employees have access to
CONFIDENTIAL INFORMATION only on a need-to-know basis and are obligated in
writing to abide by APOLLON's obligations hereunder. The foregoing
obligation shall not apply to:
4.1.1 information that is known to APOLLON or independently
developed by APOLLON prior to the time of disclosure, in each case, to the
extent evidenced by written records promptly disclosed to PENN upon receipt
of the CONFIDENTIAL INFORMATION;
4.1.2 information disclosed to APOLLON by a third party that
has a right to make such disclosure;
4.1.3 information that becomes patented, published or
otherwise part of the public domain as a result of acts by PENN or a third
person obtaining such information through no fault of APOLLON; or
4.1.4 information that is required to be disclosed by order
of United States governmental authority or a court of competent jurisdiction;
provided that APOLLON shall use its reasonable best efforts to obtain
confidential treatment of such information by the agency or court.
4.2 PENN shall not be obligated to accept any confidential
information from APOLLON. PENN bears no institutional responsibility for
maintaining the confidentiality of any confidential information of APOLLON
except PENN's Center for Technology Transfer will maintain in confidence and
not disclose sublicense agreements, reports, and records but will distribute
royalties received according to PENN's patent policy.
11
License Agreement (I)--Apollon/Penn
2 December 1994 version
4.3 The placement of a copyright notice on any CONFIDENTIAL
INFORMATION shall not be construed to mean that such information has been
published and will not release APOLLON from its obligation of confidence
hereunder.
4.4 Nothing herein shall be construed to prevent the disclosure of
CONFIDENTIAL INFORMATION as necessary to practice commercially the rights
granted hereunder including without limitation, the disclosure of
CONFIDENTIAL INFORMATION to regulatory or other governmental agencies as
necessary to obtain marketing approval, or to obtain patent protection, or
the disclosure of CONFIDENTIAL INFORMATION under a confidentiality agreement
as appropriate to development of products hereunder.
ARTICLE 5. TERM AND TERMINATION
5.1 This AGREEMENT, unless sooner terminated as provided herein,
shall terminate upon the expiration of the last to expire or become abandoned
of the PENN PATENT RIGHTS or JOINT PATENT RIGHTS, at which time all rights
licensed hereunder shall convert into a fully paid license to APOLLON.
5.2 APOLLON may, at its option, terminate this AGREEMENT at any
time by doing all of the following:
5.2.1 By ceasing to make, have made, use and sell all PENN
LICENSED PRODUCTS; and
5.2.2 By terminating all sublicenses, and causing all
SUBLICENSEES to cease making, having made, using and selling all PENN
LICENSED PRODUCTS; and
5.2.3 By giving sixty (60) days notice to PENN of such
cessation and of APOLLON's intent to terminate; and
5.2.4 By tendering payment of all accrued royalties.
5.3 PENN may terminate this AGREEMENT immediately if any of the
following occur:
5.3.1 APOLLON becomes more than sixty (60) days in arrears in
payment of royalties or expenses due pursuant to this AGREEMENT and APOLLON
does not provide full payment immediately upon demand; or
5.3.2 APOLLON becomes subject to a BANKRUPTCY EVENT; or
5.3.3 APOLLON has not met milestones specified in Section
3.2; or
12
License Agreement (I)--Apollon/Penn
2 December 1994 version
5.3.4 APOLLON breaches this AGREEMENT and does not cure such
breach within sixty (60) days written notice thereof; and
5.3.5 PENN has given APOLLON sixty (60) days written notice
of intent to terminate.
5.4 If APOLLON becomes subject to a BANKRUPTCY EVENT, all duties
of PENN and all rights (but not duties) of APOLLON under this AGREEMENT shall
immediately terminate without the necessity of any action being taken either
by PENN or by APOLLON. To secure the complete and timely payment and
satisfaction of all APOLLON's royalty obligations under this AGREEMENT,
APOLLON hereby grants to PENN a security interest, effective immediately, in
APOLLON's entire right, title and interest in and to this AGREEMENT and to
all inventories of PENN LICENSED PRODUCTS now or hereafter owned by APOLLON.
In addition to any rights or remedies provided for under this AGREEMENT, PENN
shall have all of the rights and remedies of a secured party under the
Uniform Commercial Code. Upon the request and at the sole expense of PENN,
APOLLON shall execute any and all instruments or documents as shall be
reasonably necessary to evidence and perfect such security interest in any
jurisdiction.
5.5 Upon termination of this AGREEMENT, except pursuant to Section
5.1 hereof, APOLLON shall, at PENN's request, return to PENN all CONFIDENTIAL
INFORMATION fixed in any tangible medium of expression as well as any data
generated by APOLLON during the term of this AGREEMENT which will facilitate
the development of the technology directly related to PENN PATENT RIGHTS
licensed hereunder.
5.6 APOLLON's obligation to pay royalties accrued under ARTICLE 3
hereof shall survive termination of this AGREEMENT. In addition, the
provisions of ARTICLES 4, 5, 8, 9 and 10 shall survive such termination.
ARTICLE 6. PATENT MAINTENANCE AND REIMBURSEMENT
6.1 PENN shall control and diligently prosecute and maintain PENN
PATENT RIGHTS provided APOLLON shall promptly reimburse PENN for [ ]
documented attorneys' fees, expenses, official fees and other charges
incident to the preparation, prosecution and maintenance of PENN PATENT
RIGHTS. PENN shall provide APOLLON with itemized statements reflecting these
expenses and APOLLON shall reimburse PENN for such expenses within thirty
(30) days after receipt of such statement. [ ] such reimbursements will be
[ ] creditable against royalties due pursuant to ARTICLE 3 hereof on a
country by country basis; provided, however, that if APOLLON negotiates a
license with
13
License Agreement (I)--Apollon/Penn
2 December 1994 version
WISTAR, wherein [ ] of such fees, expenses, and charges are creditable
against royalties due WISTAR, such fees, expenses and charges will be [ ]
creditable against royalties due PENN; but in no event shall any royalty
payment to PENN at any time be reduced by more than [ ], on
an individual basis for each patent application and associated issued patent.
6.2 In the event that the parties elect to file one or more patent
applications comprising JOINT PATENT RIGHTS, the parties shall confer on how the
preparation and prosecution of such applications shall be accomplished. APOLLON
shall reimburse PENN for [ ] attorneys' fees, expenses, official fees and other
charges incident to the prosecution and maintenance of JOINT PATENT RIGHTS
incurred by PENN. [ ] such reimbursements shall be [ ] creditable against
royalties due pursuant to ARTICLE 3 hereof on a country by country basis.
6.3 APOLLON and its SUBLICENSEES shall comply with all United
States and foreign laws with respect to patent marking of PENN LICENSED
PRODUCTS.
6.4 All fees, costs, and expenses incurred with respect to a patent
convention or a regional authority, such as the Patent Cooperative Treaty or the
European Patent Convention, shall be apportioned on a pro rata basis to the
countries designated thereunder.
ARTICLE 7. INFRINGEMENT AND LITIGATION
7.1 PENN and APOLLON are responsible for notifying each other
promptly of any infringement of PENN PATENT RIGHTS or JOINT PATENT RIGHTS
which may come to their attention, including notice to the other of any
certification filed under the United States "Drug Price Competition and
Patent Term Restoration Act of 1984". PENN and APOLLON shall consult one
another in a timely manner concerning any appropriate response thereto.
7.2 APOLLON shall have the right, but not the obligation to
prosecute such infringement at its own expense. APOLLON shall not settle or
compromise any such suit in a manner that imposes any obligations or
restrictions on PENN or grants any rights to the PENN PATENT RIGHTS or the
PENN TECHNICAL INFORMATION, without PENN's written permission. Financial
recoveries from any such litigation will first be applied to reimburse
APOLLON for its litigation expenditures with additional recoveries being paid
to APOLLON, subject to a royalty due PENN based on the provisions of ARTICLE
3 hereof.
7.3 Such rights of Section 7.2 shall be subject to the continuing
right of PENN to intervene at PENN's own expense and
14
License Agreement (I)--Apollon/Penn
2 December 1994 version
to join APOLLON in any claim or suit for infringement of the PENN PATENT
RIGHTS and JOINT PATENT RIGHTS. Any consideration received by APOLLON in
settlement of any claim or suit shall be shared between PENN and APOLLON in
proportion with their share of the litigation expenses in such infringement
action. Financial recoveries from any such litigation will first be applied
to reimburse PENN and APOLLON for their litigation expenditures and the
portion of the additional recoveries being paid to APOLLON is subject to a
royalty due PENN based on the provisions of ARTICLE 3 hereof.
7.4 If APOLLON fails to prosecute such infringement, PENN shall
have the right, but not the obligation, to prosecute such infringement at its
own expense. In such event, financial recoveries will be retained entirely
by PENN
7.5 In any action to enforce any of the PENN PATENT RIGHTS or the
JOINT PATENT RIGHTS, either party, at the request and expense of the other
party shall cooperate to the fullest extent reasonably possible. This
provision shall not be construed to require a party to undertake any
activities, including legal discovery, at the request of any third party
except as may be required by lawful process of a court of competent
jurisdiction.
ARTICLE 8. DISCLAIMER OF WARRANTIES; INDEMNIFICATION
8.1 THE PENN PATENT RIGHTS, JOINT PATENT RIGHTS, PENN TECHNICAL
INFORMATION, PENN LICENSED PRODUCTS AND ALL OTHER TECHNOLOGY LICENSED UNDER THIS
AGREEMENT ARE PROVIDED ON AN "AS IS" BASIS AND PENN MAKE NO REPRESENTATIONS OR
WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT THERETO. BY WAY OF EXAMPLE BUT NOT
OF LIMITATION, PENN MAKES NO REPRESENTATIONS OR WARRANTIES (i) OF COMMERCIAL
UTILITY; (ii) OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE; OR (iii)
THAT THE USE OF THE PENN PATENT RIGHTS, JOINT PATENT RIGHTS, PENN TECHNICAL
INFORMATION, PENN LICENSED PRODUCTS AND ALL TECHNOLOGY LICENSED UNDER THIS
AGREEMENT WILL NOT INFRINGE ANY PATENT, COPYRIGHT OR TRADEMARK OR OTHER
PROPRIETARY OR PROPERTY RIGHTS OF OTHERS. PENN SHALL NOT BE LIABLE TO APOLLON,
APOLLON'S SUCCESSORS OR ASSIGNS OR ANY THIRD PARTY WITH RESPECT TO: ANY CLAIM
ARISING FROM THE USE OF THE PENN PATENT RIGHTS, JOINT PATENT RIGHTS, PENN
TECHNICAL INFORMATION, PENN LICENSED PRODUCTS AND ALL TECHNOLOGY LICENSED UNDER
THIS AGREEMENT OR FROM THE MANUFACTURE, USE OR SALE OF PENN LICENSED PRODUCTS;
OR ANY CLAIM FOR LOSS OF PROFITS, LOSS OR INTERRUPTION OF BUSINESS, OR FOR
INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES OF ANY KIND.
8.2 APOLLON will defend, indemnify and hold harmless PENN, its
trustees, officers, agents and employees (individually, an "INDEMNIFIED
PARTY", and collectively, the "INDEMNIFIED
15
License Agreement (I)--Apollon/Penn
2 December 1994 version
PARTIES"), from and against any and all liability, loss, damage, action,
claim or expense suffered or incurred by the INDEMNIFIED PARTIES (including
attorneys' fees) (individually, a "LIABILITY", and collectively, the
"LIABILITIES") that results from or arises out of: (a) the development, use,
manufacture, promotion, sale or other disposition, of any PENN PATENT RIGHTS,
JOINT PATENT RIGHTS, PENN TECHNICAL INFORMATION, PENN LICENSED PRODUCTS, or
any technology licensed under this AGREEMENT by APOLLON, its assignees,
SUBLICENSEES, vendors or other third parties; (b) breach by APOLLON of any
covenant or agreement contained in this AGREEMENT; and (c) the enforcement by
an INDEMNIFIED PARTY of its rights under this Section. Without limiting the
foregoing, APOLLON will defend, indemnify and hold harmless the INDEMNIFIED
PARTIES from and against any LIABILITIES resulting from:
8.2.1 any product liability or other claim of any kind
related to the use by a third party of a PENN LICENSED PRODUCT that was
manufactured, sold or otherwise disposed by APOLLON, its assignees,
SUBLICENSEES, vendors or other third parties;
8.2.2 a claim by a third party that the PENN PATENT RIGHTS,
JOINT PATENT RIGHTS or PENN TECHNICAL INFORMATION or the design, composition,
manufacture, use, sale or other disposition of any PENN LICENSED PRODUCT
infringes or violates any patent, copyright, trademark or other intellectual
property rights of such third party; and
8.2.3 clinical trials or studies conducted by or on behalf of
APOLLON relating to the PENN PATENT RIGHTS, JOINT PATENT RIGHTS, PENN
TECHNICAL INFORMATION or PENN LICENSED PRODUCTS, including, without
limitation, any claim by or on behalf of a human subject of any such clinical
trial or study, any claim arising from the procedures specified in any
protocol used in any such clinical trial or study, any claim of deviation,
authorized or unauthorized, from the protocols of any such clinical trial or
study, and any claim resulting from or arising out of the manufacture or
quality control by a third party of any substance administered in any
clinical trial or study;
8.2.4 provided, however, that APOLLON'S obligation to defend,
indemnify, and hold harmless hereunder shall not apply to any liability,
claim, damage, loss, cost or expense to the extent it is attributable to the
proven negligence, or proven reckless or intentional misconduct of any
INDEMNIFIED PARTY hereunder.
8.3 The INDEMNIFIED PARTY shall promptly notify APOLLON of any
claim or action giving rise to LIABILITIES subject to the provisions of the
foregoing Section. APOLLON shall have the right to defend any such claim or
action, at its cost and expense. APOLLON shall not settle or compromise any
such claim or action in a manner that imposes any restrictions or
16
License Agreement (I)--Apollon/Penn
2 December 1994 version
obligations on PENN or grants any rights to the PENN PATENT RIGHTS, PENN
TECHNICAL INFORMATION or PENN PATENTED PRODUCTS without PENN's prior written
consent. If APOLLON fails or declines to assume the defense of any such
claim or action within thirty (30) days after notice thereof, PENN may assume
the defense of such claim or action for the account and at the risk of
APOLLON, and any LIABILITIES related thereto shall be conclusively deemed a
liability of APOLLON. APOLLON shall pay promptly to the INDEMNIFIED PARTY
any LIABILITIES to which the foregoing indemnity relates, as incurred. The
indemnification rights of PENN or other INDEMNIFIED PARTY contained herein
are in addition to all other rights which such INDEMNIFIED PARTY may have at
law or in equity or otherwise.
8.4 INSURANCE
8.4.1 APOLLON shall procure and maintain a policy or policies
of comprehensive general liability insurance, including broad form and
contractual liability to be written on an occurrence or a claims made basis,
in a minimum amount of $1,000,000 combined single limit per occurrence and in
the aggregate as respects personal injury, bodily injury and property damage
arising out of APOLLON's performance of this AGREEMENT.
8.4.2 APOLLON shall, upon commencement of clinical trials
involving PENN LICENSED PRODUCTS, procure and maintain a policy or policies
of product liability insurance to be written on an occurrence or a claims
made basis in a minimum amount of $3,000,000 combined single limit per
occurrence and in the aggregate as respects bodily injury and property damage
arising out of APOLLON's performance of this AGREEMENT.
8.4.3 The policy or policies of insurance specified herein
shall be issued by an insurance carrier with a rating of "A-" or better by
A.M. Best and shall name PENN as an additional insured with respect to
APOLLON's performance of this AGREEMENT. APOLLON shall provide PENN with
certificates evidencing the insurance coverage required herein and all
subsequent renewals thereof. Such certificates shall provide that APOLLON's
insurance carrier(s) notify PENN in writing at least 30 days prior to
cancellation or material change in coverage.
8.4.4 PENN shall periodically review the adequacy of the
minimum limits of liability specified herein. Further, PENN reserves the
right to negotiate with APOLLON to adjust such coverage limits accordingly.
The specified minimum insurance amounts shall not constitute a limitation on
APOLLON's obligation to indemnify PENN under this AGREEMENT.
17
License Agreement (I)--Apollon/Penn
2 December 1994 version
ARTICLE 9. USE OF PENN'S NAME
9.1 APOLLON and its employees and agents shall not use and APOLLON
shall not permit its SUBLICENSEES to use PENN's name, any adaptation thereof,
any PENN logotype, trademark, service xxxx or slogan or the name xxxx or
logotype of any PENN representative or organization in any way without the
prior, written consent of PENN.
ARTICLE 10. ADDITIONAL PROVISIONS
10.1 APOLLON shall comply with all prevailing laws, rules and
regulations pertaining to the development, testing, manufacture, marketing,
sale, use, import or export of products. Without limiting the foregoing, it
is understood that this AGREEMENT may be subject to United States laws and
regulations controlling the export of technical data, computer software,
laboratory prototypes and other commodities, articles and information,
including the Arms Export Control Act as amended in the Export Administration
Act of 1979, and that the parties obligations hereunder are contingent upon
compliance with applicable United States export laws and regulations. The
transfer of certain technical data and commodities may require a license from
the cognizant agency of the United States Government and/or written
assurances by APOLLON that APOLLON shall not export data or commodities to
certain foreign countries without prior approval of such agency. PENN
neither represents that a license is not required nor that, if required, it
will issue.
10.2 This AGREEMENT and the rights and duties appertaining thereto
may not be assigned by APOLLON without first obtaining the express written
consent of PENN; provided, however, that such consent shall not be required
in the event of transfer by APOLLON of all or substantially all of the
business to which this AGREEMENT pertains. Any such purported assignment,
except as permitted herein without the written consent of PENN, shall be null
and of no effect.
10.3 Notices under this AGREEMENT shall be in writing and sent by
public courier and addressed as follows:
If to PENN:
University of Pennsylvania
Center for Technology Transfer
0000 Xxxxxx Xxxxxx, Xxxxx 000
Xxxxxxxxxxxx, XX 00000-0000
Attention: Managing Director
18
License Agreement (I)--Apollon/Penn
2 December 1994 version
with a copy to:
Office of the General Counsel
University of Pennsylvania
000 Xxxxxxx Xxxx
Xxxxxxxxxxxx, XX 00000-0000
Attention: General Counsel
If to APOLLON:
Xxxxxxx X. Xxxxxxx, Ph.D.
Vice President of Technical Development
Apollon, Inc.
Xxx Xxxxx Xxxxxx Xxxxxxx
Xxxxx 00
Xxxxxxx, XX 00000-0000
Either party may change its official address upon written notice to the other
party.
10.4 This AGREEMENT shall be construed and governed in accordance
with the laws of the Commonwealth of Pennsylvania, without giving effect to
conflict of law provisions.
10.5 This AGREEMENT and the SPONSORED RESEARCH AGREEMENT
(Attachment 4 hereto) each is related to the other in setting forth the
entire agreement of the parties. Any modification of this AGREEMENT shall be
in writing and signed by an authorized representative of both parties.
10.6 In the event that a party to this AGREEMENT perceives the
existence of a dispute with the other party concerning any right or duty
provided for herein, the parties shall, as soon as practicable, confer in an
attempt to resolve the dispute. If the parties are unable to resolve such
dispute amicably, then the parties hereby submit to the exclusive
jurisdiction of and venue in any state or federal courts located within the
Eastern District of Pennsylvania with respect to any and all disputes
concerning the subject of this AGREEMENT.
10.7 A waiver by a party of a breach or violation of any provision
of this AGREEMENT will not constitute or be construed as a waiver of any
subsequent breach or violation of that provision or as a waiver of any breach
or violation of any other provision of this AGREEMENT.
10.8 Any of the provisions of this AGREEMENT which are determined
to be invalid or unenforceable in any jurisdiction shall be ineffective to
the extent of such invalidity or unenforceability in such jurisdiction,
without rendering invalid or unenforceable the remaining provisions hereof or
affecting the
19
License Agreement (I)--Apollon/Penn
2 December 1994 version
validity or unenforceability of any of the terms of this AGREEMENT in any
other jurisdiction.
10.9 The headings and captions used in this AGREEMENT are for
convenience of reference only and shall not affect its construction or
interpretation.
10.10 Nothing herein shall be deemed to establish a relationship
of principal and agent between PENN and APOLLON nor any of their agents or
employees, nor shall this AGREEMENT be construed as creating any form of
legal association or arrangement which would impose liability upon one party
for the act or failure to act of the other party. Nothing in this AGREEMENT,
express or implied, is intended to confer on any person, other than the
parties hereto or their permitted assigns, any benefits, rights or remedies.
10.11 PENN and APOLLON shall not discriminate against any employee
or applicant for employment because of race, color, sex, sexual or
affectional preference, age, religion, national or ethnic origin, handicap or
because he or she is a disabled veteran or veteran of the Vietnam Era.
IN WITNESS WHEREOF the parties, intending to be legally bound, have caused this
AGREEMENT to be executed by their duly authorized representatives and to be
effective the first date written above.
THE TRUSTEES OF THE APOLLON, INC.
UNIVERSITY OF PENNSYLVANIA
By: /s/ Xxxxxxx Xxxxxxx By: /s/ Xxxxxxx X. Xxxxxxxx, Xx.
------------------------------- ------------------------------
Name: Xxxxxxx Xxxxxxx Name: Xxxxxxx X. Xxxxxxxx, Xx.
----------------------------- ----------------------------
Executive Director
Title: Sponsored Programs Title: President & CEO
---------------------------- ---------------------------
Date: December 2, 1994 Date: 5 Dec 94
----------------------------- ----------------------------
License Agreement (I)--Apollon/Penn
2 December 1994 version
Attachment 1
TECHNOLOGY LIST
[ ] "Genetic Immunization;" patent application 08/008,342 filed 26
January 1993; X. Xxxxxx, X. Xxxxxxxx, and X. Xxxx.
[ ] "Genetic Immunization;" patent application 08/029/336 filed 11
March 1993; X. Xxxxxx, X. Xxxxxxxx, and X. Xxxx.
[ ] "Genetic Immunization;" patent application 08/125,012 filed 21
September 1993;" X. Xxxxxx, X. Xxxxxxxx, X. Xxxx, and X. Xxxxx.
[ ] "Delivery of Genetic Material by Needleless Injection Devices;"
patent application 08/093,235 filed 15 July 1993; X. Xxxxxx.
[ ] "Non-Human Immunocompetent Animal Model;" patent application
08/124,962 filed 21 September 1993; X. Xxxxxx, X. Xxxxxxxx, and
X. Xxxxx.
[ ] "Compositions and Methods for Deliver of Genetic Material;"
patent application PCT/US94/00899 filed 26 January 1994; X.
Xxxxxx, X. Xxxxxxxx, X. Xxxx, X. Xxxxx, X. Xxxxx, and X.
Xxxxxxxx.
21
License Agreement (I)--Apollon/Penn
2 December 1994 version
Attachment 5.
MILESTONES
1. Performance Milestones:
1.1 Within [ ] of the EFFECTIVE DATE of the AGREEMENT, APOLLON
will have caused an Investigational New Drug (IND) application for a
PENN LICENSED PRODUCT to be submitted to the FDA.
2. Research and Development Milestones:
2.1 For the [ ] of this AGREEMENT, APOLLON will fund
sponsored research at PENN in the amount of [ ].
2.2 For the [ ] of this AGREEMENT, APOLLON will develop
internally the skills and resources necessary to develop and
commercialize PENN LICENSED PRODUCTS. Thereafter, APOLLON's internal
research, development, and commercialization efforts or the combined
efforts of APOLLON and any APOLLON affiliate, any APOLLON joint
venture, and any APOLLON development partnership formed to develop
and/or commercialize PENN LICENSED PRODUCTS, will be funded at a
minimum of [ ] for at least [ ].
License Agreement (I)--Apollon/Penn
2 December 1994 version
SCHEDULE TO LICENSE AGREEMENT BETWEEN
APOLLON, INC. AND THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
DATED DECEMBER 1, 1994
On December 1, 1994, the same date on which Apollon, Inc. (the
"Registrant") and the Trustees of the University of Pennsylvania ("Penn")
entered into the License Agreement to which this schedule is attached ("License
Agreement I"), the Registrant and Penn also entered into a License Agreement
relating to the HIV vpr gene, vpr protein and vpr receptor ("License Agreement
II"). License Agreement I and License Agreement II are identical except for the
following differences:
1. License Agreement I relates to nucleic acid constructs and License
Agreement II relates to the HIV vpr gene.
2. The patent applications associated with License Agreement I are owned
by Penn and The Wistar Institute of Anatomy and Biology related to work by Xx.
Xxxxxxx X. Xxxxxxxx and Xx. Xxxxx X. Xxxxxx and the patent applications
associated with License Agreement II are owned by Penn related to work by Xx.
Xxxxx X. Xxxxxx.
3. Certain fees and royalties have different dollar values in License
Agreement I as compared to License Agreement II. All fees and royalties are
confidential and subject to the confidential treatment request filed with the
Securities and Exchange Commission.
License Agreement II has not been filed as a separate exhibit to the
Registrant's Registration Statement in accordance with Instruction 2 to Item 601
of Regulation S-K.
