SETTLEMENT AGREEMENT
AND
MUTUAL GENERAL RELEASE
This Settlement Agreement and Mutual General Release (hereinafter
"Agreement") is entered into this 17th day of February, 2000 between Washington
University (hereinafter "WU"), having its principal office at Xxx Xxxxxxxxx
Xxxxx, Xxxxx Xxxxx, Xxxxxxxx 00000 and Xxxxx Xxxxxxxx, Ph.D., Professor of
Molecular Microbiology at WU, and SIGA Pharmaceuticals, Inc. (hereinafter
"SIGA"), a corporation duly organized and existing under the laws of the State
of Delaware and having its principal office at 000 Xxxxxxxxx Xxxxxx, Xxxxx 000,
Xxx Xxxx, Xxx Xxxx 00000.
Recitals
WHEREAS, WU through its research funded in part by WU, SIGA and others
have developed intellectual property comprising patent rights, copyrights,
know-how and technical data;
WHEREAS, SIGA is in the business of researching, developing, and
commercializing products based upon such intellectual property rights;
WHEREAS, on or about July 9, 1997 Xx. Xxxxxxxx and SIGA entered into a
personal consulting agreement (hereinafter "PCA") under which Xx. Xxxxxxxx
agreed to provide consulting services to SIGA regarding, among other things,
providing scientific scrutiny of programs funded by SIGA with respect to the
appropriateness of its research and development
programs and potential impact of alternative technologies, advising SIGA
concerning developments in research and the potential of such developments as a
basis for developing new products and recommending persons who might be
appropriate as consultants or scientific staff for SIGA;
WHEREAS, on or about February 6, 1998 WU and SIGA entered into a Research
Collaboration and Licensing Agreement which was amended by letter agreement on
October 21, 1998 (hereinafter "RCLA") regarding the intellectual property rights
associated and generated under a research collaboration between SIGA and WU with
Xx. Xxxxxxxx as the primary investigator under the agreement;
WHEREAS, on or about July 23, 1999, WU made a demand for arbitration
regarding disputes arising from the RCLA pursuant to the rules of the American
Arbitration Association as required under the RCLA, and on July 26, 1999, SIGA
made a counter-demand for arbitration;
WHEREAS, on or about July 28, 1999 SIGA brought suit against Xx. Xxxxxxxx
in the United States District Court for the Southern District of New York
alleging various causes of action relating to the subject matter of both the PCA
and the RCLA;
WHEREAS, the parties hereto wish to settle the disputes regarding the RCLA
and the PCA, and any other disputes which exist or may exist between them on the
terms stated herein;
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NOW, THEREFORE, in consideration of the mutual promises and covenants
contained in this Agreement, and for good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged by all the parties
hereto, the parties agree as follows:
Covenants and Conditions
1. Research Collaboration and Licensing Agreement. The Research
Collaboration and Licensing Agreement (hereinafter "RCLA") between WU and SIGA
and all rights granted therein (except as specifically noted below) are
terminated effective February 6, 1999. No obligations imposed on either party
under the RCLA, except for the maintenance of confidentiality regarding the
other party's confidential information under Article 7 of the RCLA, will survive
termination. Title to all equipment purchased under the RCLA and physically
maintained by WU hereby vests in WU.
2. Personal Consulting Agreements. All personal consulting agreements
between SIGA and any WU faculty members and/or employees, including the PCA
between SIGA and Xx. Xxxxxxxx, are hereby terminated. SIGA will neither propose
nor enter into any new consulting agreements with WU faculty members and/or
employees without first receiving WU's written consent.
3. Mutual Releases. Except with respect to the obligations created by or
arising out of this Agreement, SIGA for itself and on behalf of its parent,
subsidiary, and other affiliated corporations, divisions, directors, officers,
employees, agents, affiliates, representatives, and assigns who may claim
through it hereby release, acquit and forever discharge and covenant not to xxx
individually or collectively WU, Xx. Xxxxxxxx and/or their agents, employees,
insurers,
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directors, officers, successors and assigns for, of and from any and all claims,
demands, damages, debts, liabilities, accounts, reckonings, obligations, costs,
expenses, liens, actions and causes of action of every kind and nature
whatsoever, including right to contribution or indemnification, equitable or
declaratory relief, whether now known or unknown, suspected or unsuspected,
which SIGA or its related parties either now has, owns or holds or at any time
heretofore ever had, owned or held, or could, shall or may hereafter have, own
or hold, resulting or to result from occurrences that happened at any time up
until the signing of this agreement, including, but not limited to, those
relating to, based upon or arising out of the RCLA, the PCA, or any other
personal consulting agreement with WU faculty members and/or employees, or any
of the facts or transactions asserted in the aforesaid arbitration proceedings
and suit by any of the parties. (All of which released claims are hereinafter
referred to as "SIGA's Released Matters"), SIGA and Xx. Xxxxxxxx will promptly
file after the effective date of this Agreement a Stipulation of Discontinuance
with Prejudice of SIGA's action against Xx. Xxxxx Xxxxxxxx in Action no. 99 Civ,
6017 (DAB) pending in the United States District Court for the Southern District
of New York.
Except with respect to the obligations created by or arising out of this
Agreement, WU, Xx. Xxxxxxxx, for themselves and an behalf of their agents,
employees, insurers, directors, officers, successors, assigns and others who may
claim through them hereby release, discharge and covenant not to xxx
individually or collectively SIGA, its parent, subsidiary and other affiliated
corporations, divisions, directors, officers, employees, agents, insurers and
its successors and assigns for, of and from any and all claims, demands,
damages, debts, liabilities, accounts, reckonings, obligations, costs, expenses,
liens, actions and causes of action of every kind and nature whatsoever,
including right to contribution or indemnification, equitable or declaratory
relief, whether now known or unknown, suspected or unsuspected, which WU, Dr.
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Xxxxxxxx or their related parties either now has, owns or holds or at any time
heretofore ever had, owned or held, or could, shall or may hereafter have, or
own or hold, resulting or to result from occurrences that happened at any time
prior to the signing of this agreement, including, but not limited to, those
relating to, based upon or arising out of the RCLA, the PCA, or any other
personal consulting agreement with WU faculty members and/or employees, or any
of the facts or transactions which were or could have been asserted in the
aforesaid arbitration proceedings and suit by any of the parties. (All of which
released claims are hereinafter referred to as "WU's Released Matters").
The parties shall promptly file a mutual termination notice with the
American Arbitration Association concluding such proceedings in accordance with
this settlement.
It is the intention of the parties that this Agreement shall be effective
as a full and final accord and satisfaction and mutual release of and from all
of SIGA's Released Matters and WU's Released Matters.
4. Contract Construction. The parties hereby agree that this Agreement
shall be construed, interpreted, and applied in accordance with the following:
a. The invalidity or unenforceability of any provision hereof shall
in no way affect the validity or enforceability of any other provision of this
Agreement.
b. This Agreement contains the entire agreement among the parties
hereto and supersedes and cancels all previous agreements, negotiations,
commitments and writings with respect to the subject matter hereof, and may not
be released, discharged, abandoned, changed, or modified in any manner, orally
or in writing, except by an instrument in writing signed by a duly
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authorized officer of each of the parties hereto. Any attempt to modify this
Agreement orally or in writing not duly executed by all parties hereto shall be
void.
c. This Agreement shall be deemed executed and delivered within the
state of Missouri, and the rights and obligations of the parties hereunder shall
be construed and enforced in accordance with, and governed by, the laws of the
State of Missouri.
d. No waiver of any breach of any term or provision of this
Agreement shall be construed to be, nor shall be, a waiver of any other breach
of this Agreement.
5. Effective date. The effective date of this Agreement shall be the date
on which this Agreement is finally executed by all parties hereto.
6. Confidentiality of the Agreement. Each party agrees to keep secret and
confidential the terms of this agreement except as follows. WU and its related
parties may disclose this Agreement and its terms to the extent necessary to
negotiate rights in the technology and related intellectual property to
prospective or future existing licensees or other recipients of such rights, or
to the extent necessary for it to comply with requirements for financial grant
applications or other funding agreements related to the technology. SIGA may
disclose this Agreement and its terms to the extent necessary for it to comply
with its reporting obligations as a public company, to the extent necessary for
it to comply with requirements for financial grant applications or other funding
agreements related to the technology, to the extent necessary to make required
bona fide disclosures to prospective investors in SIGA and to the extent
necessary to negotiate rights in
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technology and related intellectual property to prospective clients regarding
pharmaceutical transactions when such disclosure should reasonably be made. All
parties may disclose portions of this Agreement as necessary for each party to
comply with a valid Court Order, federal and/or state agency or private action
subpoenas, provided reasonable notice is given to the other party of the Order
or subpoena prior to responding thereto.
7. Warranty of Persons executing this Agreement. Each person whose
signature appears below warrants and guarantees, on behalf of him or herself,
and on behalf of the party for whom he or she is executing this Agreement, that
such person had been duly authorized and has full authority to execute this
Agreement on behalf of the party for whom he or she is executing this Agreement.
8. Publicity. Notwithstanding any provisions of this Agreement:
a. Neither WU nor Xx. Xxxxxxxx may use the name or marks of SIGA or
of any of its employees or subcontractors in advertising, publicity or otherwise
without the prior written approval of SIGA; or
b. Neither SIGA nor any of its affiliates or employees may use the
name or marks of WU, nor the name of Xx. Xxxxxxxx, nor the names of other
investigators or employees of WU in advertising, publicity or otherwise without
the prior written approval of WU.
9. Patent Expenses. WU will reimburse SIGA the cost of patent expenses
arising from the RCLA in the amount of $37,037.04 within thirty (30) days of the
execution of this agreement.
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10. Patent Rights. SIGA disclaims any rights, title or interest in and
hereby expressly assigns any rights, title and interest it has or may claim to
have in any proprietary technology, patents, patent applications, inventions and
improvements related to the RCLA project as defined in sections 1.8, 1.11 (as
amended, 10/21/98), 1.12, 1.17, and 1.18 of the RCLA to WU, whether developed by
WU employees or contractors and/or by SIGA employees or contractors. This
agreement does not encompass certain rights, title or interest SIGA has or
claims in certain patents and/or patent applications not arising from the RCLA
and which are specifically set forth in Appendix A attached hereto. In
particular, as to the patent rights associated with U.S. patent application
serial no. 60/140,990 (DegP Periplasmic Protease), Washington University and
SIGA each claim rights in said application based on inventorship by their
respective employees or agents. As to the remaining patents and/or patent
applications set forth in Appendix A, Washington University and SIGA each claim
rights in said patents or applications, on Washington University's part, based
on inventorship by its employees or agents, and on SIGA's part, based on
inventorship by employees or agents of Symbicom (AB) and on a written assignment
of Symbicom's patent rights therein to SIGA. Unless otherwise indicated by
subsequent agreement, WU and SIGA will equally share responsibility for the
administration and the expenses for the prosecution of patent applications
and/or patents specifically set forth in Appendix A attached hereto.
WU and SIGA have entered into a licensing agreement regarding U.S. Patent
Number 5,834,591 entitled "Polypeptides and Antibodies Useful for the Diagnosis
and Treatment of Pathogenic Neisseria and Other Micro Organisms having Type IV
Pilin" which technology was incorporated into the RCLA by letter amendment dated
October 21, 1998. The licensing agreement is attached hereto as Appendix B and
is hereby incorporated into this agreement.
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11. Licensing Revenues. WU agrees to pay SIGA a licensing revenue of 20%
of the first $2,000,000.00 of net licensing revenues (that is, up to
$400,000.00) that derive from the commercialization of products covered by valid
claims under any patent rights of section 10 of this Agreement, and 10% of the
next $1,0O0,000.00 of the net licensing revenues (that is, up to an additional
$100,000.00) that derive from the commercialization of products covered by valid
claims under any patent rights of section 10 of this Agreement, with the total
payment of licensing revenues to SIGA not to exceed $500,000.00 under any
circumstances. WU and SIGA agree that "net licensing revenues" includes
licensing fees, license maintenance fees, milestone payments and royalties, but
that "net licensing revenues" expressly excludes any research support funds.
12. Government Rights. This Agreement is subject to any rights pursuant to
research funding from the Federal Government, if any, and will be modified as
necessary to conform to government regulations.
13. Admissions. Nothing in this Agreement or the settlement of this
dispute shall constitute or be construed as an admission with respect to the
merits of any claim or cause of action, or of any other matter of law or fact
heretofore asserted in any proceeding by any party hereto. The parties further
agree that no representation of fact or opinion has been made by one of them to
the other with respect to the extent or nature of the claims or damages in order
to induce this compromise.
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[SENNIGER, POWERS, XXXXXXX & XXXXXX LETTERHEAD]
February 18, 2000
Xxxxxxx X. Xxxxxxx-Xxxxx, Esq.
Xxxxxx, Xxxxxxxx & Xxxx, P.C.
000 Xxxxxxx Xxxxxx
Xxx Xxxx, XX 00000
Re: Washington University vs. SIGA Pharmaceuticals, Inc.
Our File XXXX 0000
Dear Xxxxxxx:
Enclosed please find fully executed originals of the Settlement Agreement
and Release and Nonexclusive License Agreement.
I will call you soon to discuss matters related to the pending patent
estate.
Yours truly,
/s/ G. Xxxxxx Xxxxxxx
G. Xxxxxx Xxxxxxx
GHB/bk
Enclosures
cc: Xxxxxx Neighbour (via fax)
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14. Agent. No party shall be deemed to be an agent of another party as a
result of any transaction under or related to this Agreement, and shall not in
any way pledge the other party's credit or incur any obligation on behalf of the
other party.
15. Advice of Counsel. Each party has had the advice of counsel of their
own choosing before executing this Agreement. Each party also acknowledges that
they have reviewed this Agreement prior to execution and the execution hereof is
their free act and deed.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
duly executed in their respective corporate names by their duly authorized
officers, or in their individual capacity, as of the dates indicated.
/s/ Xxxxx Xxxxxxxx
----------------------------------------
Xx. Xxxxx Xxxxxxxx
Date: 2/17/00
----------------------------------
SIGA Pharmaceuticals, Inc.
By: /s/ Xxxxxx X. Xxxxxx
------------------------------------
Name: Xxxxxx X. Xxxxxx
----------------------------------
Title: Chief Executive Officer
---------------------------------
Date: 2/14/00
----------------------------------
Washington University
By: /s/ Xxxxxxxx X. Xxxxxx
------------------------------------
Name: Xxxxxxxx X. Xxxxxx, Ph.D.
----------------------------------
Title: Vice Chancellor for Research
---------------------------------
Date: 2/17/00
----------------------------------
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APPENDIX A
Patent Rights
1. U.S. Serial Number 60/140,990
DegP Periplasmic Protease, a New Anti-Infective Target and an In Vivo
Assay for DegP Protease Function.
2. New Zealand Application 311902:
Treatment or Prophylaxis of Diseases Caused by Pilus-Forming Bacteria.
3. Japanese Application Number 514666
Treatment or Prophylaxis of Diseases Caused by Pilus-Forming bacteria
4. Australian Patent Number 704114
Compounds and Pharmaceutical Compositions for the Treatment and
Prophylaxis of Bacterial Infections.
5. Canadian Application Number 2176808
Compounds and Pharmaceutical Compositions for the Treatment and
Prophylaxis of Bacterial Infections.
6. European Patent Application Number 95902653
A New Method for the Treatment and Prophylaxis of Bacterial Infection.
7. U.S. Serial Number 08/154,035 - Abandoned
Treatment or Prophylaxis of Diseases Caused by Pilus-Forming Bacteria.
8. U.S. Serial Number O8/462,436
Method for Treatment and Prophylaxis of Bacterial Infections.
9. U.S. Serial Number 08/465,275
Treatment or Prophylaxis of Diseases Caused by Pilus-Forming Bacteria.
10. U.S. Serial Number 08/640,877
Compounds and Pharmaceutical Compositions for the Treatment and
Prophylaxis of Bacterial Infections.
11. PCT/US94/13455 - Abandoned
Treatment or Prophylaxis of Diseases Caused by Pilus-Forming Bacteria.
APPENDIX B
NONEXCLUSIVE LICENSE AGREEMENT
Between
Washington University in St. Louis
Licensor
And
SIGA Pharmaceuticals, Inc.
Licensee
Introduction: This Agreement is made and entered into this ___ day of February,
2000 by and between Washington University in St. Louis, a corporation
established by special act of the Missouri General Assembly approved February
22, 1853 and acts amendatory thereto, having its principal office at Xxx
Xxxxxxxxx Xxxxx, Xx. Xxxxx, Xxxxxxxx 00000 (hereinafter "WU") and SIGA
Pharmaceuticals, Inc., having its principal office at 000 Xxxxxxxxx Xxx, Xxxxx
000, Xxx Xxxx, XX 00000 (hereinafter "SIGA"). WU and SIGA may be referred to
individually as a "Party" or collectively as the "Parties".
1. Background. WU is the owner of certain Patent Rights, Tangible Research
Property and Technical Information (collectively, Intellectual Property,
all as hereinafter defined) relating to polypeptides and antibodies useful
for the diagnosis and treatment of pathogenic Neisseria and other
organisms having Type IV pilin, and WU has the right to grant licenses
thereto. WU wishes to allow the Intellectual Property to be used to
further scientific research and for new product development and other
applications in the public interest and is willing to grant a license for
such uses. SIGA represents to WU that it has the necessary product
development, manufacturing and marketing capabilities to commercialize
products based on such Intellectual Property. SIGA desires to obtain a
license to use these properties and information for its own commercial
research and development endeavors upon the terms and conditions set forth
in this Agreement. In consideration of these premises and the mutual
promises contained herein, the Parties further agree as follows.
2. Definitions. For the purposes of this Agreement, the following words and
phrases will have the meanings assigned to them below.
2.1 Agreement: This nonexclusive license agreement.
2.2 Calendar Half/Year: Each six months period or portion thereof beginning on
January 1 or July 1; or each twelve month period, or portion thereof,
beginning on January 1.
2.3 Combination Product: Any product that is comprised in part of a Licensed
Product and in part of one or more other components which are not
themselves Licensed Products (the "Other Components"). Other Components do
not include surfactants, diluents and carriers.
2.4 Effective Date: [The day, month and year written in the Introduction].
2.5 Field: Human and veterinary antimicrobial therapeutic and prophylactic
compounds and vaccines.
2.6 First Commercial Sale: The date of first transfer by SIGA or its
Sublicensees to an unrelated third party of a Licensed Product for
compensation (including equivalent cash value for trades or other non-cash
payments). The transfer of Licensed Products by SIGA and its Sublicensees
strictly for its own laboratory research and development purposes,
beta-testing and/or clinical testing does not constitute a First
Commercial Sale for the purposes of this Agreement, provided that SIGA
receives no payment for such Licensed Product in excess of the fully
burdened (i.e., direct and indirect) costs of producing and transporting
such materials.
2.7 Intellectual Property: Patent Rights patents and patent applications,
trademarks, service marks, copyrights, mask works, trade secrets, Tangible
Research Property and Technical Information.
2.8 Licensed Product: Any product or service which is made, made for, used,
sold or imported by SIGA and/or its Sublicensees which (a) in the absence
of this license Agreement would infringe at least one valid claim, (b)
uses, is used in, or is made using a process covered by a valid claim, or
(c) is made with or derived from a compound or composition covered by a
valid claim. Licensed Product includes any product made, and method or
process used, in whole or in part using Tangible Research Property or
Technical Information.
2.9 Net Sales: For purposes of computing royalties, gross amounts received by
SIGA or its Sublicensees for Sales of Licensed Products less qualifying
costs, taxes and discounts, as set forth below, which are
actually invoiced and borne by SIGA and its Sublicensees. Deductions for
calculating Net Sales are limited to the following:
2.9.1 Trade, quantity and cash discounts
2.9.2 Credits, allowances or refunds, not exceeding the original invoice
amount, for claims, damaged goods, rejections or returns.
2.9.3 Prepaid outbound transportation expenses and freight insurance premiums
2.9.4 Excise, sale, use, value added or other taxes levied by a governmental
agency, other than income taxes.
2.10 Patent Rights: US Patent No. 5,834,591 and all foreign counterparts,
continuations, continuations-in-part, divisions, extensions,
reexaminations and reissues thereof, which trace their earliest priority
filing date by unbroken lineage to this patent and its parent
applications.
2.11 Sale: Any transaction in which a Licensed Product is exchanged for value.
A Sale of a Licensed Product will be deemed to have been made at the time
SIGA or its Sublicensee invoices, ships, or receives value for, whichever
occurs first, a Licensed Product.
2.12 Sublicensee: A person or entity to which SIGA has granted a sublicense
under the license rights granted to SIGA in Article 3 of this Agreement.
2.13 Sublicensing Revenue: All fees and cash equivalent for securities,
equipment and other property received by SIGA from its Sublicensees for
the grant of any sublicense. Said Sublicensing Revenue will exclude any
research payments made to SIGA by any Sublicensee.
2.14 Tangible Research Property: The physical embodiments of Patent Rights and
Technical Information, including all progeny and derivatives thereof.
2.15 Technical Information: All ideas, data, know-how, trade secrets, research
information, methods, procedures or processes, biological or chemical
materials, owned by WU, resulting from research performed by or under the
direction of Xx. Xxxxxxx Xxxxxxx et al, which contribute to the practice
of the inventions in the Patent Rights and the commercialization of
Licensed Products.
2.16 Term: Commences on the Effective Date and continues until the expiration
of the last of the patents included in the Patent Rights to expire,
unless earlier terminated in accordance with this Agreement. A patent will
be understood to expire at midnight on the day of its expiration.
2.17 Territory: Anywhere in the world except for countries to which export of
technology or goods is prohibited by applicable U.S. export control laws
or regulations.
2.18 Valid Claim: A claim (a) of a pending Patent Rights patent application
which claim has not been pending for longer than seven years, or (b) of an
issued and unexpired Patent Rights patent which has not been held invalid
or unenforceable by a court or other governmental agency of competent
jurisdiction in a decision or order that is not subject to an appeal.
3. License Grant. Subject to the terms and conditions set forth in this
Agreement, WU hereby grants to SIGA and SIGA hereby accepts, the following
license during the Term in the Territory:
3.1 A nonexclusive, fee- and royalty-bearing license, including the right to
grant sublicenses, under the Intellectual Property, to make, have made,
sell, offer for sale, use, and import Licensed Products in the Field.
3.2 The right to grant sublicenses granted to SIGA under this Agreement is
subject to the following conditions:
3.2.1 In each sublicense, SIGA must prohibit the Sublicensee from further
sublicensing and require that the Sublicensee is subject to the terms
and conditions of the license granted to SIGA under this Agreement.
3.2.2 Within thirty days of the effective date of any sublicense, SIGA must
send to WU a complete copy of the sublicense. If the original sublicense
is written in a language other than English, then SIGA must also send to
WU within the allotted time a translation of the sublicense written in
English.
3.2.3 If SIGA enters bankruptcy or receivership, voluntarily or involuntarily,
Sublicensing Revenue then or thereafter due to SIGA will, upon notice
from WU to any Sublicensee, become owed directly to WU for the account
of SIGA. WU will remit to SIGA any amounts received that exceed the sum
actually owed by SIGA to WU.
3.2.4 Any sublicense granted by SIGA under this Agreement will remain in
effect in the event that this Agreement is terminated prior to
expiration. Any Sublicensee will automatically become a direct licensee
of WU under the rights originally sublicensed to it by SIGA provided the
Sublicensee did not cause the termination of this Agreement and the
Sublicensee agrees to comply with all the terms of this Agreement and to
fulfill all the responsibilities of SIGA hereunder.
3.2.5 SIGA will be primarily liable to WU for all of SIGA's obligations
contained in this Agreement. Any act or omission by a Sublicensee that
would be a breach of this Agreement if imputed to SIGA will be deemed to
be a breach by SIGA of this Agreement.
3.3 The license "to have made" granted in Section 3.1 means that SIGA or its
Sublicensee may contract with a third party or parties to manufacture
Licensed Products for SIGA or its Sublicensee. SIGA will require any
contractors to assume confidentiality obligations consonant with Article 6
of this Agreement.
3.4 SIGA and its Sublicensees have no ownership rights of any kind in the
Intellectual Property licensed under this Agreement. All ownership rights
remain the property of WU. WU will retain all original versions of
Tangible Research Property and Technical Information licensed and will
retain control over the same at all times. The delivery of Tangible
Research Property and Technical Information and grant of license rights
thereto under this Agreement do not constitute a sale of the same.
3.5 In accordance with Public Laws 96-517, 97-256 and 98-620, codified at 35
U.S.C. section section 200-212, the United States government retains
certain rights to inventions arising from federally supported research or
development. Under these laws and implementing regulations, the government
may impose requirements on such Inventions. Licensed Products embodying
inventions subject to these laws and regulations sold in the United States
must be substantially manufactured in the United States. The license
rights granted in this Agreement are expressly made subject to these laws
and regulations as they may be amended from time to time. SIGA agrees to
abide by these laws and regulations.
3.6 SIGA will ensure that where applicable "Patent Pending" or the Patent
Rights patent number or application serial number appears on all Licensed
Products or their labels.
4. Fees, Payments and Royalties.
4.1 License Maintenance Payments. SIGA must pay to WU non-refundable,
non-creditable license maintenance payments as follows:
4.1.1 Payment equal to $10,000 per each Calendar Year Beginning on January 1,
2001 and each year thereafter.
4.1.2 The payments required in Sections 4.1.1 must be made no later than January
31 of each respective Calendar Year. License maintenance payments cease
the Calendar Year following the Year in which the First Commercial Sale in
the U.S. of a Licensed Product occurs.
4.2 SIGA will pay WU ten percent (10%) of all Sublicensing Revenue received
from its Sublicensees within 30 days of receipt by SIGA.
4.3 Milestone Payments. SIGA will pay the following milestone payments for
each discrete molecule that is a Licensed Product under this Agreement as
follows:
i. Completion of Phase I IND clinical trials - $50,000;
ii. Completion of Phase II IND clinical trials - $50,000;
iii. Completion of Phase III IND clinical trials - $200,000; and
iv. Product approval (PLA) - $250,000
4.4 Minimum Royalty. SIGA must pay to WU a non-refundable minimum royalty of
$50,000 for each Licensed Product sold by SIGA and/or its Sublicensees.
The first calendar period for which the minimum royalty will be paid will
begin on the first day of the Calendar Half following the Calendar Half in
which the First Commercial Sale in the U.S. of that Licensed Product
occurs.
4.5 Earned Royalty. SIGA must pay to WU an earned royalty of one percent (1%)
of the Net Sales of Licensed Product(s) made, made for, used, imported or
sold by SIGA or its Sublicensees.
4.5.1 Earned royalties paid are fully creditable against minimum royalties
called for in Section 4.4 for the period in which the earned royalties
are accumulated and reported.
4.5.2 Earned royalties will be accumulated and reported each Calendar Half.
SIGA will pay to WU earned royalties accumulated during a Calendar Half
on the January 31 or July 31 immediately following the end of that
Calendar Half.
4.6 Licensed Products may be made, used, imported or sold in combination
with or as part of other products which are covered by a claim of a
third party's patent or by other intellectual property rights of a third
party, requiring a license to enable
SIGA to make, use, sell or offer for sale, or import Combination Products.
To calculate the value of Net Sales of Combination Products, the gross
sales of such Products will be multiplied by the fraction A/(A + B) where
A is the fair market value of the Licensed Product when sold separately,
and B is the fair market value of the Other Component when sold
separately. Allowed deductions may then be subtracted from the proportion
of gross sales attributable to the Licensed Product to compute Net Sales.
4.7 When a Licensed Product or its manufacture, use, sale or importation is
covered by more than one Valid Claim or patent or patent application
within the Patent Rights licensed hereunder, SIGA will only be obligated
to pay royalties and fees or make payments as if there were only one Valid
Claim.
4.8 Patent expenses will be borne equally by WU and SIGA. SIGA will reimburse
WU within thirty (30) days of receipt of invoices for one half of incurred
patent expenses. If WU grants additional nonexclusive licenses, then
future costs will be borne pro rata by WU, SIGA, and all such licensees.
5. Place and Method of Payment; Reports and Records; Audit; Interest.
5.1 All dollar ($) amounts referred to in this Agreement are expressed in
United States dollars. All payments to WU under this Agreement must be
made in United States dollars by check or electronic transfer payable to
"Washington University". Any Sales revenues for Licensed Products received
by SIGA in currency other than United States dollars will be converted to
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 in the United States of the applicable Calendar Half.
5.2 Checks will be dispatched to WU's correspondence address given in Article
14 below. Electronic transfers will be made to a bank account designated
by WU.
5.3 SIGA must deliver to WU within the time provided in Article 4 for making
the respective payment after the end of each Calendar Half in which earned
royalties are owed and payable, a written report setting forth the
calculation of the payments made to WU for that Calendar Half, including
at least the following:
5.3.1 The number of Licensed Products manufactured, sold, used or imported and
volume of Sales by country.
5.3.2 Gross receipts for Sales of Licensed Products including total amounts
invoiced, billed or received.
5.3.3 Allowed deductions as defined in Section 2.9, giving totals by each
type.
5.3.4 Net Sales of Licensed Products by country.
5.3.5 Royalties, fees and payments due to WU giving totals for each category.
5.3.6 Earned royalty amounts credited against minimum royalty payments or vice
versa.
5.4 SIGA must maintain, and require its Sublicensees to maintain, complete and
accurate books of account and records which would enable an independent
auditor to verify the amounts paid as royalties, fees and payments under
this Agreement. The books and records must be maintained for five years
following the Calendar Half after submission of the reports required by
this Article. Upon reasonable notice by WU, SIGA must give WU (or auditors
or inspectors appointed by and representing WU) access to all books and
records relating to Sales of Licensed Products by SIGA to conduct an audit
or review of those books and records. This access must be available at
least once during each Calendar Half, for a reasonable time, during
regular business hours, during the Term of the Agreement and for the five
calendar years following the year in which termination or expiration
occurs. If the independent auditor determines that amounts paid to WU as
royalties, fees and payments by SIGA differ by 5% or more from amounts
actually owed for any Calendar Half, then SIGA must pay WU the costs and
expenses of its accountants and auditors in connection with the review and
audit.
5.5 Any amounts that are not paid by SIGA to WU within thirty (30) days of the
due date will accrue interest from the due date until payment is made at
an annual rate equal to two percent above the prime rate published in the
Eastern edition of The Wall Street Journal during the period of arrearage
(or the maximum allowed by law, if less than prime.) This provision
applies to all payments that SIGA must make under this Agreement.
6. Confidentiality.
6.1 All Patent Rights patent applications, Tangible Research Property and
Technical Information designated by WU representatives as confidential at
the time of delivery to SIGA, or within a reasonable period after said
delivery, and all of Articles 4 and 5 of this Agreement, are Confidential
Information.
6.2 SIGA will maintain in secrecy and not disclose to any third party any of
WU's Confidential Information after it has been so designated. SIGA will
ensure that its employees have access to WU's Confidential Information
only on a need-to-know basis and are obligated by written agreement to
keep SIGA's confidentiality obligations under this Agreement.
6.3 The obligations of confidentiality specified in this Article will not
extend to Confidential Information which:
6.3.1 Becomes part of the public domain through no fault of SIGA.
6.3.2 Was known to SIGA before disclosure to SIGA by WU as established by
clear and convincing documentary evidence;
6.3.3 Comprises identical subject matter to that which had been originally and
independently developed by SIGA personnel without knowledge or use of
any WU Confidential Information; or
6.3.4 Was disclosed to SIGA by a third party, having a right to make the
disclosure.
6.4 Notwithstanding the other terms of this Article 6, SIGA may, to the extent
necessary, use Confidential Information to secure governmental approval to
clinically test or market a Licensed Product, to comply with a court order
or governmental rule or regulation, or to show to a potential contractor
subject to an appropriate confidentiality agreement. SIGA will, in any
such use, take all reasonably available steps to maintain confidentiality
of the disclosed information and to guard against any further disclosure.
7. Representations and Warranties.
7.1 WU represents and warrants that:
7.1.1 WU is a corporation organized, existing and in good standing under the
laws of Missouri.
7.1.2 It has the authority to enter into this Agreement and that the person
signing on its behalf has the authority to do so.
7.1.3 To the best of its knowledge, it is the owner (subject to any rights
retained by the U.S. government by operation of law of the Intellectual
Property licensed in this Agreement and that it has the authority to
grant the licenses set forth herein.
7.2 SIGA represents and warrants that:
7.2.1 It is a corporation duty organized, existing, and in good standing under
the laws of Delaware.
7.2.2 The execution, delivery and performance of this Agreement have been
authorized by all necessary corporate action on the part of SIGA and
that the person signing the Agreement on behalf of SIGA has the
authority to do so.
7.2.3 The making or performance of this Agreement would not violate any
separate agreement it has with any other person or entity.
7.2.4 It is not a party to any agreement or arrangement that would prevent it
from performing its duties and fulfilling its obligations to WU under
this Agreement.
7.2.5 Has the insurance coverage called for in Article 10.
7.2.6 Is unaware of any pending litigation or claims against SIGA that could
impair its ability or capacity to perform and fulfill its duties and
obligations under this Agreement.
7.3 Nothing in this Agreement is or will be construed as:
7.3.1 A warranty or representation by WU as to the validity or scope of its
Patent Rights, Tangible Research Property or Technical Information.
7.3.2 Granting by implication, estoppel or otherwise any licenses or rights
under patents or other intellectual property rights of WU or other
persons, other than the rights expressly granted above to Intellectual
Property identified on the attached Exhibits.
7.3.3 An obligation to furnish any technology or technological information
other than that identified in the attached Exhibits.
7.3.4 A grant of rights to either Party to use the name of the other in
advertising, publicity, or otherwise, except as expressly authorized
herein, without the permission of the other Party.
7.4 THE INTELLECTUAL PROPERTY IS PROVIDED "AS IS" AND WU MAKES NO
REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR
FITNESS OF ANY LICENSED PRODUCT FOR A PARTICULAR PURPOSE, OR THAT THE USE
OF ANY
LICENSED PRODUCT WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK OR
OTHER RIGHTS, OR ANY OTHER EXPRESS OR IMPLIED WARRANTIES. WU WILL NOT BE
LIABLE TO SIGA ITS SUCCESSORS, ASSIGNS, CONTRACTORS OR SUBLICENSEES OR ANY
THIRD PARTY REGARDING ANY CLAIM ARISING FROM SIGA's USE OF LICENSED
INTELLECTUAL PROPERTY OR ANY LICENSED PRODUCT OR FROM THE MANUFACTURE,
USE, IMPORTATION OR SALE OF 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. Infringement, Enforcement, and Defense.
8.1 This license includes the right, revocable by WU, to bring actions in WU's
name to enforce the Intellectual Property rights against third parties or
to defend the same in WU's name against claims by third parties, subject
to the terms and conditions set forth in this Agreement
8.2 WU and SIGA will immediately give to the other written notice of any known
or suspected infringement of the Patent Rights or unauthorized use of the
Tangible Research Property or Technical Information by third parties.
8.3 SIGA at its sole expense, if SIGA is the sole licensee (or prorated with
other licensees if any), will attempt to xxxxx any infringement of the
Patent Rights or unauthorized use of Tangible Research Property or
Technical Information by third parties. SIGA has the right to institute
and conduct actions against third parties for infringement and unfair
trade practices through outside counsel of its choice who are reasonably
acceptable to WU. SIGA will keep WU informed of all proceedings and
provide copies of all pleadings and other papers related to such actions.
WU will provide reasonable assistance to SIGA in prosecuting any such
actions.
8.4 SIGA at its sole expense will defend third party claims of patent or
intellectual property infringement and injury, death or product liability
brought against SIGA and/or WU. SIGA will have the right to conduct the
defense of such actions through outside counsel of its choice who are
reasonably acceptable to WU. WU will provide all reasonable assistance for
the defense of such claims and SIGA will keep WU informed of all
proceedings and provide copies of all pleadings and other papers related
to such actions.
8.5 If more than one nonexclusive licensee participates in bringing or
defending an action under this Article, then the costs and fees for such
action will be shared pro-rata among such licensees.
8.6 Notwithstanding anything stated herein to contrary, SIGA will not be
permitted to settle or compromise any claim or action in a manner that may
impose restrictions or obligations on WU or grant rights or concessions to
Intellectual Property or Licensed Products without WU's prior written
consent.
8.7 SIGA will be entitled to offset 50% of its attorney's fees and expenses
incurred in abating third party infringement or unfair trade practices or
bringing or defending any action against third parties under this Article,
against the royalties due under Sections 4.4 and 4.5.
9. Indemnification. SIGA and its Sublicensees will indemnify, defend and hold
harmless WU, its trustees, faculty, staff, students and agents from and
against any and all liability, loss, damage, action, claim or expense
(including attorney's fees and costs at trial and appellate levels) in
connection with any claim, suit, action, demand or judgment arising out of
(a) the use of any Intellectual Property in the design, development,
production, manufacture, sale or offer for sale, use, importation, lease,
marketing or promotion of any Licensed Product by SIGA or its
Sublicensees, contractors or agents or (b) injury or death to any person,
or damage to property caused or allegedly caused by or relating in any way
to any person's use of any Licensed Products, or (c) any third party claim
that any use or licensing of the Intellectual Property under this
Agreement violates or infringes that party's intellectual property rights.
In legal actions undertaken or defended by SIGA pursuant to this
indemnification provision, SIGA may select counsel of its own choice who
are reasonably acceptable to WU.
10. Insurance.
10.1 SIGA and its Sublicensees will at all times comply, through insurance or
self-insurance, with all statutory workers' compensation and employers'
liability requirements covering all employees with respect to activities
undertaken in performance of this Agreement. This requirement may be met
by insurance or self-insurance coverage provided to SIGA by a Sublicensee.
10.2 In addition to the foregoing, SIGA and any Sublicensees as appropriate,
will at appropriate times obtain and maintain occurrence-based Broad Form
Comprehensive General Liability (BFCGL) insurance with a reputable and
financially secure insurance carrier(s) having at least an "A" rating and
An A.M. Best Class Size of at least X. Deviations from the rating or class
size must be approved in advance by WU. The BFCGL insurance will include,
among all other coverages standing in
such BFCGL policies, coverage for product liability and contractual liability.
10.3 The insurance will provide to SIGA or each Sublicensee minimum annual
limits of $2 million in liability insurance for the WU Licensed Products,
and list WU as an additional insured.
10.4 All policies will be purchased and kept in force during the term of the
Agreement.
10.5 SIGA or any Sublicensee as appropriate, will provide WU with a certificate
of insurance and will provide a complete copy of the insurance policy to
WU as soon as one becomes available and notices or subsequent renewals.
The certificate must provide that SIGA's carrier will notify WU in writing
at least thirty days prior to cancellation or material change in coverage.
10.6 WU may periodically evaluate the adequacy of the minimum coverages of
insurance specified in this Article. WU reserves the right to require SIGA
to adjust the insurance coverages. The specified minimum coverages do not
constitute a limitation on SIGA's or its Sublicensees' obligation to
indemnify WU under this Agreement.
11. Termination.
11.1 SIGA may terminate this Agreement with or without cause on ninety days
written notice to WU. The license rights granted hereunder terminate at
the end of the ninety day period.
11.2 WU may terminate on thirty days written notice to SIGA upon breach by SIGA
of the Agreement. The termination becomes effective at the end of the
thirty day period unless SIGA has fully cured the breach within the thirty
days.
11.3 If SIGA enters bankruptcy or receivership, voluntarily or involuntarily,
all obligations of WU and all rights (but not obligations) of SIGA and
this Agreement terminate immediately without the need for either WU or
SIGA to take any action.
11.4 Upon termination of this Agreement for any reason, SIGA must return to WU
all Confidential Information (as defined in Article 6) received from WU
during the Term of this Agreement.
11.5 On termination by either Party for any reason, the license rights granted
to SIGA under Article 3 terminate when termination of the Agreement is
effective. SIGA's obligations to pay fees, royalties or other payments
accruing prior to termination survive termination.
12. Use of Names. Neither Party may use the name of the other for any
commercial, advertisement, or promotional purpose without the written
consent of the other.
13. Assignment or Pledge of Agreement. Neither this Agreement nor any portion
of it may be assigned by either Party to anyone else without the written
consent of the other Party, and such consent will not be unreasonably
withheld. Notwithstanding this, SIGA may assign the entire Agreement,
without WU's consent, to an entity that succeeds to substantially all of
its business or assets by way of merger, sale, acquisition or otherwise,
provided that the successor agrees in writing to assume all the
obligations and liabilities of SIGA to WU. The rights granted in this
Agreement may not be pledged in any way by SIGA or any Sublicensee to
secure any purchase, lease or loan.
14. Notice. Any required or permissive notice under this Agreement will be
sufficient if in writing and delivered personally, by recognized national
overnight courier, or by registered or certified mail, postage prepaid and
return receipt requested, to the address below and will be deemed to have
been given as of the date shown on the receipt if by certified or
registered mail, or the day following dispatch if by overnight courier.
If to WU:
Washington University
Center of Technology Management
Campus Box 8013
000 Xxxxx Xxxxxx Xxxxxx
Xx. Xxxxx XX 00000
If to SIGA:
Xxxxxx X. Xxxxxx
SIGA Pharmaceuticals, Inc.
000 Xxxxxxxxx Xxxxxx
Xxxxx 000
Xxx Xxxx, XX 00000
15. General Provisions.
15.1 This Agreement will be governed and interpreted according to the laws of
Missouri.
15.2 None of the terms or this Agreement can be waived except by mutual written
consent of the Parties.
15.3 This Instrument comprises the entire agreement and understanding of the
Parties relating to the subject matter of the Agreement.
15.4 This Agreement cannot be changed, modified or amended except by a written
instrument subscribed by authorized representatives of the respective
Parties.
15.5 Neither Party is an agent or contractor of the other as a result of any
transaction under or related to this Agreement. Neither Party may in any
way pledge the other party's credit or incur any obligation on behalf of
the other Party.
15.6 Each Party is liable to the other only for actual damages for breach of
this Agreement or any warranty contained herein, and not for any special,
consequential, incidental, or indirect damages arising out of this
Agreement, however caused, under any theory of liability.
15.7 The provisions of this Agreement are severable in that if any provision in
the Agreement is determined to be invalid or unenforceable under any
controlling body of law, that will not affect the validity or
enforceability of the remaining provisions of the Agreement.
15.8 If the performance of any obligation under this Agreement is prevented or
impaired by acts of war, riot, acts or defaults of common carriers, or
governmental laws or regulations, a Party will be excused from performance
so long as such cause continued to prevent or impair that Party's
performance. The Party claiming force majeure excuse must promptly notify
the other Party of the existence of the cause and must at all times use
diligent efforts to resume and complete performance. This Section 15.8
will not excuse SIGA's obligation to pay fees, payments and royalties
under Article 4 of the Agreement.
15.9 WU has no responsibility for product design and development, servicing,
distribution, or marketing, or any decisions made or strategies devised in
areas related to Licensed Products.
15.l0 Articles 4, 5, 6, 9, 10, and 12 above will survive expiration or
termination of this Agreement.
15.11 This Agreement will be executed in two original versions, one belonging to
each Party. The originals are valid counterparts of each other.
Witness: The parties have caused this Agreement to be executed in duplicate by
their duly qualified representatives.
For SIGA For WU:
----------------------------------- -----------------------------------
Signature Signature
Name Name
Title Title
------------ ------------
Date Date
NON EXCLUSIVE LICENSE AGREEMENT
Between
Washington University in St. Louis
Licensor
And
SIGA Pharmaceuticals, Inc.
Licensee
Introduction: This Agreement is made end entered into this 17th day of February,
2000 by and between Washington University in St. Louis, a corporation
established by special act of the Missouri General Assembly approved February
22, 1853 and acts amendatory thereto, having its principal office at Xxx
Xxxxxxxxx Xxxxx, Xx. Xxxxx, Xxxxxxxx 00000, (hereinafter "WU") and SIGA
Pharmaceuticals, Inc., having its principal office at 000 Xxxxxxxxx Xxx, Xxxxx
000, Xxx Xxxx, XX 00000 (hereinafter "SIGA"). WU and SIGA may be referred to
individually as a "Party" or collectively as the "Parties".
1. Background. WU is the owner of certain Patent Rights, Tangible Research
Property and Technical Information (collectively, Intellectual Property,
all as hereinafter defined) relating to polypeptides and antibodies useful
for the diagnosis and treatment of pathogenic Nelsseria and other
organisms having type IV pllln, and WU has the right to grant licenses
thereto. WU wishes to allow the Intellectual Property to be used to
further scientific research end for new product development and other
applications in the public interest and is willing to grant a license for
such uses. SIGA represents to WU that it has the necessary product
development, manufacturing and marketing capabilities to commercialize
products based on such Intellectual Property. SIGA desires to obtain a
license to use these properties and information for its own commercial
research and development endeavors upon the terms and conditions set forth
in this Agreement, In consideration of these premises and the mutual
promises contained herein, the Parties further agree as follows.
2. Definitions. For the purposes of this Agreement, the following words and
phrases will have the meanings assigned to them below.
2.1 Agreement: This nonexclusive license agreement.
2.2 Calendar Half/Year: Each six month period or portion thereof beginning on
January 1 or July 1; or each twelve month period, or portion thereof,
beginning on January 1.
2.3 Combination Product: Any product that is comprised in part of a Licensed
Product and in part of one or more other components which are not
themselves Licensed Products (the "Other Components"). Other Components do
not include surfactants, diluents and carriers.
2.4 Effective Date: [The day, month and year written in the Introduction].
2.5 Field: Human and veterinary antimicrobial therapeutic and prophylactic
compounds and vaccines.
2.6 First Commercial Sale: The date of first transfer by SIGA or its
Sublicensees to an unrelated third party of a Licensed Product for
compensation (including equivalent cash value for trades or other non-cash
payments). The transfer of Licensed Products by SIGA and its Sublicensees
strictly for its own laboratory research and development purposes,
beta-testing and/or clinical testing does not constitute a First
Commercial Sale for the purposes of this Agreement, provided that SIGA
receives no payment for such Licensed Product in excess of the fully
burdened (i.e., direct and indirect) costs of producing end transporting
such materials.
2.7 Intellectual Property: Patent Rights patents and patent applications,
trademarks, service marks, copyrights, mask works, trade secrets, Tangible
Research Property and Technical Information.
2.8 Licensed Product: Any product or service which is made, made for, used,
sold or imported by SIGA and/or its Sublicensees which (a) in the absence
of this license Agreement would infringe at least one valid claim, (b)
uses, is used in, or is made using a process covered by a valid claim, or
(c) is made with or derived from a compound or composition covered by a
valid claim. Licensed Product includes any product made, and method or
process used, in whole or in part using Tangible Research Property or
Technical Information.
2.9 Net Sales: For purposes of computing royalties, gross amounts received by
SIGA or its Sublicensees for Sales of Licensed Products less qualifying
costs, taxes and discounts, as set forth below, which are
actually invoiced and borne by SIGA and its Sublicensees. Deductions for
calculating Net Sales are limited to the following:
2.9.1 Trade, quantity and cash discounts
2.9.2 Credits, allowances or refunds, not exceeding the original invoice
amount, for claims, damaged goods, rejections or returns.
2.9.3 Prepaid outbound transportation expenses and freight insurance
premiums
2.9.4 Excise, sale, use, value added or other taxes levied by a
governmental agency, other than income taxes.
2.10 Patent Rights: US Patent No. 5,834,591 and all foreign counterparts,
continuations, continuations-in-part, divisions, extensions,
reexaminations and reissues thereof, which trace their earliest priority
filing date by unbroken lineage to this patent and its parent
applications.
2.11 Sale: Any transaction in which a Licensed Product is exchanged for value.
A Sale of a Licensed Product will be deemed to have been made at the time
SIGA or its Sublicensee Invoices, ships, or receives value for, whichever
occurs first, a Licensed Product.
2.12 Sublicensee: A person or entity to which SIGA has granted a sublicense
under the license rights granted to SIGA in Article 3 of this Agreement.
2.13 Sublicensing Revenue: All fees and cash equivalent for securities,
equipment and other property received by SIGA from its Sublicensees for
the grant of any sublicense. Said Sublicensing Revenue will exclude any
research payments made to SIGA by any Sublicensee.
2.14 Tangible Research Property: The physical embodiments of Patent Rights
Information, including all progeny and derivatives thereof.
2.15 Technical Information: All ideas, data, know-how, trade secrets, research
information, methods, procedures or processes, biological or chemical
materials, owned by WU, resulting from research performed by or under the
direction of Xx. Xxxxxxx Xxxxxxx et al, which contribute to the practice
of the inventions in the Patent Rights and the commercialization of
Licensed Products.
2.16 Term: Commences on the Effective Date and continues until the expiration
of the last of the patents included in the Patent Rights to expire, unless
earlier terminated in accordance with this Agreement. A patent will be
understood to expire at midnight on the day of its expiration.
2.17 Territory: Anywhere in the world except for countries to which export of
technology or goods is prohibited by applicable U.S. export control laws
or regulations.
2.18 Valid Claim: A claim (a) of a pending Patent Rights patent application
which claim has not been pending for longer than seven years, or (b) of an
issued and unexpired Patent Rights patent which has not been held Invalid
or unenforceable by a court or other governmental agency of competent
jurisdiction in a decision or order that is not subject to an appeal.
3. License Grant. Subject to the terms and conditions set forth in this
Agreement, WU hereby grants to SIGA and SIGA hereby accepts, the following
license during the Term in the Territory:
3.1 A nonexclusive, fee- and royalty-bearing license, including the right to
grant sublicenses, under the Intellectual Property, to make, have made,
sell, offer for sale, use, and import Licensed Products in the Field.
3.2 The right to grant sublicenses granted to SIGA under this Agreement is
subject to the following conditions:
3.2.1 In each sublicense, SIGA must prohibit the Sublicensee from further
sublicensing and require that the Sublicensee is subject to the terms and
conditions of the license granted to SIGA under this Agreement.
2.9.1 Trade, quantity and cash discounts
3.2.2 Within thirty days of the effective date of any sublicense, SIGA must
send to WU a complete copy of the sublicense. If the original
sublicense is written in a language other than English, then SIGA
must also send to WU within the allotted time a translation of the
sublicense written in English.
3.2.3 If SIGA enters bankruptcy or receivership, voluntarily or
involuntarily, Sublicensing Revenue then or thereafter due to SIGA
will, upon notice from WU to any Sublicensee, become owed directly to
WU for the account of SIGA. WU will remit to SIGA any amounts received
that exceed the sum actually owed by SIGA to WU.
3.2.4 Any sublicense granted by SIGA under this Agreement will remain in
effect in the event that this Agreement is terminated prior to
expiration. Any Sublicensee will automatically become a direct
licensee of WU under the rights originally sublicensed to it by SEGA
provided the
Sublicensee did not cause the termination of this Agreement and the
Sublicensee agrees to comply with all the terms of this Agreement and
to fulfill all the responsibilities of SIGA hereunder.
3.2.5 SIGA will be primarily liable to WU for all of SIGA's obligations
contained in this Agreement. Any act or omission by a Sublicensee that
would be a breach of this Agreement if imputed to SIGA will be deemed
to be a breach by SIGA of this Agreement.
3.3 The license "to have made" granted in Section 3.1 means that SIGA or its
Sublicensee may contract with a third party or parties to manufacture
Licensed Products for SIGA or its Sublicensee. SIGA will require any
contractors to assume confidentiality obligations consonant with Article 6
of this Agreement.
3.4 SIGA and its Sublicensees have no ownership rights of any kind in the
Intellectual Property licensed under this Agreement. All ownership rights
remain the property of WU. WU will retain all original versions of
Tangible Research Property and Technical Information licensed and will
remain control over the same at all times. The delivery of Tangible
Research Property and Technical Information and grant of license rights
thereto under this Agreement do not constitute a sale of the same.
3.5 In accordance with Public Laws 96-517, 97-256 and 98-620, codified at 35
U.S.C. xx.xx. 200-212, the United States government retains certain rights
to Inventions arising from federally supported research or development.
Under these laws and implementing regulations, the government may impose
requirements on such inventions. Licensed Products embodying inventions
subject to these laws and regulations sold in the United States must be
substantially manufactured in the United States. The license rights
granted in this Agreement are expressly made subject to these laws and
regulations as they may be amended from time to time. SIGA agrees to abide
by these laws and regulations.
3.6 SIGA will ensure that where applicable "Patent Pending" or the Patent
Rights patent number or application serial number appears on all Licensed
Products or their labels.
4. Fees, Payments and Royalties.
4.1 License Maintenance Payments. SIGA must pay to WU non-refundable,
non-creditable license maintenance payments as follows:
4.1.1 Payments equal to $10,000 per each Calendar Year beginning January 1,
2001 and each year thereafter.
4.1.2 The payments required in Sections 4.1.1 must be made no later than
January 31 of each respective Calendar Year. License maintenance
payments cease the Calendar Year following the Year in which the First
Commercial Sale in the U.S. of a Licensed Product occurs.
4.2 SIGA will pay WU ten percent (10%) of all Sublicensing Revenue received
from its Sublicensees within 30 days of receipt by SIGA.
4.2 Milestone Payments. SIGA will pay the following milestone payments for
each discrete molecule that is a Licensed Product under this Agreement as
follows:
i. Completion of Phase I IND clinical trials - $50,000;
ii. Completion of Phase II IND clinical trials - $50,000;
iii. Completion of Phase III IND clinical trials - $200,000; and
iv. Product approval (PLA) - $250,000
4.4 Minimum Royalty. SIGA must pay to WU a non-refundable minimum royalty of
$50,000 for each Licensed Product sold by SIGA and/or its Sublicensees.
The first calendar period for which the minimum royalty will be paid will
begin on the first day of the Calendar Half following the Calendar Half in
which the First Commercial Sale in the U.S. of that Licensed Product
occurs.
4.5 Earned Royalty. SIGA must pay to WU an earned royalty of one percent (1%)
of the Net Sales of Licensed Product(s) made, made for, used, imported or
sold by SIGA or its Sublicensees.
4.5.1 Earned royalties paid are fully creditable against minimum royalties
called for in Section 4.4 for the period in which the earned royalties
are accumulated and reported.
4.5.2 Earned royalties will be accumulated and reported each Calendar Half.
SIGA will pay to WU earned royalties accumulated during a Calendar
Half on the January 31 or July 31 immediately following the end of
that Calendar Half.
4.6 Licensed Products may be made, used, imported or sold in combination with
or as part of other products which are covered by a claim of a third
party's patent or by other intellectual property rights of a third party,
requiring a license to enable
SIGA to make, use, sell or offer for sale, or import Combination Products.
To calculate the Value of Net Sales of Combination Products, the gross
sales or such Products will be multiplied by the fraction A/(A + B) where
A is the fair market value of the Licensed Product when sold separately,
and B is the fair market value of the Other Component when sold
separately. Allowed deductions may then be subtracted from the proportion
of gross sales attributable to the Licensed Product to compute Net Sales.
4.7 When a Licensed Product or its manufacture, use, sale or importation is
covered by more than one Valid Claim or patent or patent application,
within the Patent Rights licensed hereunder, SIGA will only be obligated
to pay royalties and fees or make payments as if there were only one Valid
Claim.
4.8 Patent expenses will be borne equally by WU and SIGA. SIGA will reimburse
WU within thirty (30) days of receipt of invoices for one half of incurred
patent expenses. If WU grants additional non-exclusive licenses, then
future costs will be borne pro rata by WU, SIGA, and all such licensees.
5. Place and Method of Payment; Reports and Records; Audit; Interest.
5.1 All dollar ($) amounts referred to in this Agreement are expressed in
United States dollars. All payments to WU under this Agreement must be
made in United States dollars by check or electronic transfer payable to
"Washington University". Any Sales revenues for Licensed Products received
by SIGA in currency other than United States dollars will be converted to
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 in the United States of the applicable Calendar Half.
5.2 Checks will be dispatched to WU's correspondence address given in Article
14 below. Electronic transfers will be made to a bank account designated
by WU.
5.3 SIGA must deliver to WU within the time provided in Article 4 for making
the respective payment after the end of each Calendar Half in which earned
royalties are owed and payable, a written report setting forth the
calculation of the payments made to WU for that Calendar Half, including
at least the following:
5.3.1 The number of Licensed Products manufactured, sold, used or imported
and volume of Sales by country.
5.3.2 Gross receipts for Sales of Licensed Products including total amounts
invoiced, billed or received.
5.3.3 Allowed deductions as defined in Section 2.9, giving totals by each
type.
5.3.4 Net Sales of Licensed Products by country.
5.3.5 Royalties, fees and payments due to WU giving totals for each
category.
5.3.6 Earned royalty amounts credited minimum royalty payments or vice
versa.
5.4 SIGA must maintain, and require its Sublicensees to maintain, complete and
accurate books of account and records which would enable an independent
auditor to verify the amounts paid as royalties, fees and payments under
this Agreement. The books and records must be maintained for five years
following the Calendar Half after submission of the reports required by
this Article. Upon reasonable notice by WU, SIGA must give WU (or auditors
or inspectors appointed by and representing WU) access to all books end
records relating to Sales of Licensed Products by SIGA to conduct an audit
or review of those books and records. This access must be available at
least once during each Calendar Half, for a reasonable time, during
regular business hours, during the Term of the Agreement and for the five
calendar years following the year in which termination or expiration
occurs. If the independent auditor determines that amounts paid to WU as
royalties, fees and payments by SIGA differ by 5% or more from amounts
actually owed for any Calendar Half, then SIGA must pay WU the costs and
expenses of its accountants and auditors in connection with the review and
audit.
5.5 Any amounts that are not paid by SIGA to WU within thirty (30) days of the
due date will accrue interest from the due date until payment is made at
an annual rate equal to two percent above the prime rate published in the
Eastern edition of The Wall Street Journal during the period of arrearage
(or the maximum allowed by law, if less than prime.) This provision
applies to all payments that SIGA must make under this Agreement.
6. Confidentiality.
6.1 All Patent Rights patent applications, Tangible Research Property and
Technical Information designated by WU representatives as confidential at
the time of delivery to SIGA, or within a reasonable period after said
delivery, and all of Articles 4 and 5 of this Agreement, are Confidential
Information.
6.2 SIGA will maintain in secrecy and not disclose to any third party any of
WU's Confidential Information after it has been so designated. SIGA will
ensure that its employees have access to WU's Confidential Information
only on a need-to-know basis and are obligated by written agreement to
keep SIGA's confidentiality obligations under this Agreement.
6.3 The obligations of confidentiality specified in this Article will not
extend to Confidential Information which:
6.3.1 Becomes part of the public domain through no fault of SIGA.
6.3.2 Was known to SIGA before disclosure to SIGA by WU as established by
clear and convincing documentary evidence;
6.3.3 Comprises identical subject matter to that which had been originally
and independently developed by SIGA personnel without knowledge or use
of any WU Confidential Information; or
6.3.4 Was disclosed to SIGA by a third party having a right to make the
disclosure.
6.4 Notwithstanding the other terms of this Article 6, SIGA may, to the extent
necessary, use Confidential Information to secure governmental approval to
clinically test or market a Licensed Product, to comply with a court order
or governmental rule or regulation, or to show to a potential contractor
subject to an appropriate confidentiality agreement. SIGA will, in any
such use, take all reasonably available steps to maintain confidentiality
of the disclosed Information and to guard against any further disclosure.
7. Representations and Warranties.
7.1 WU represents and warrants that:
7.1.1 WU is a corporation organized, existing and in good standing under the
laws of Missouri.
7.1.2 It has the authority to enter into this Agreement and that the person
signing on its behalf has the authority to do so.
7.1.3 To the best of its knowledge, it is the owner (subject to any rights
retained by the U.S. government by operation of law) of the
Intellectual Property licensed in this Agreement and that it has the
authority to grant the licenses set forth herein.
7.2 SIGA represents and warrants that:
7.2.1 It is a corporation duly organized, existing, and in good standing
under the laws of Delaware.
7.2.2 The execution, delivery and performance of this Agreement have been
authorized by all necessary corporate action on the part of SIGA and
that the person signing the Agreement on behalf of SIGA has the
authority to do so.
7.2.3 The making or performance of this Agreement would not violate any
separate agreement it has with any other person or entity.
7.2.4 It is not a party to any agreement or arrangement that would prevent
it from performing its duties and fulfilling its obligations to WU
under this Agreement.
7.2.5 Has the insurance coverage called for in Article 10.
7.2.6 Is unaware of any pending litigation or claims against SIGA that could
impair its ability or capacity to perform and fulfill its duties and
obligations under this Agreement.
7.3 Nothing in this Agreement is or will be construed as:
7.3.1 A warranty or representation by WU as to the validity or scope of its
Patent Rights, Tangible Research Property or Technical Information.
7.3.2 Granting by implication, estoppel or otherwise any licenses or rights
under patents or other intellectual property rights of WU or other
persons, other than the rights expressly granted above to Intellectual
Property identified on the attached Exhibits.
7.3.3 An obligation to furnish any technology or technological information
other than that identified in the attached Exhibits.
7.3.4 A grant of rights to either Party to use the name of the other in
advertising, publicity, or otherwise, except as expressly authorized
herein, without the permission of the other Party.
7.4 THE INTELLECTUAL PROPERTY IS PROVIDED "AS IS" AND WU MAKES NO
REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR
FITNESS OF ANY LICENSED PRODUCT FOR A PARTICULAR PURPOSE, OR THAT THE USE
OF ANY
LICENSED PRODUCT WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK OR
OTHER RIGHTS, OR ANY OTHER EXPRESS OR IMPLIED WARRANTES. WU WILL NOT BE
LIABLE TO SIGA ITS SUCCESSORS, ASSIGNS, CONTRACTORS OR SUBLICENSEES OR ANY
THIRD PARTY REGARDING ANY CLAIM ARISING FROM SIGA's USE OF LICENSED
INTELLECTUAL PROPERTY OR ANY LICENSED PRODUCT OR FROM THE MANUFACTURE,
USE, IMPORTATION OR SALE OF LICENSED PRODUCTS, OR ANY CLAIM FOR LOSS OR
PROFITS, LOSS OR INTERRUPTION OF BUSINESS, OR FOR INDIRECT, SPECIAL OR
CONSEQUENTIAL DAMAGES OF ANY KIND.
8. Infringement, Enforcement, and Defense.
8.1 This license includes the right, revocable by WU, to bring actions in WU's
name to enforce the Intellectual Property rights against third parties or
to defend the same in WU's name against claims by third parties, subject
to the terms and conditions set forth in this Agreement.
8.2 WU and SIGA will immediately give to the other written notice of any known
or suspected infringement of the Patent Rights or unauthorized use of the
Tangible Research Property or Technical Information by third parties.
8.3 SIGA at its sole expense, if SIGA is the sole licensee (or prorated with
other licensees if any), will attempt to xxxxx any infringement of the
Patent Rights or unauthorized use of Tangible Research Property or
Technical Information by third parties. SIGA has the right to institute
and conduct actions against third parties for Infringement and unfair
trade practices through outside counsel of its choice who are reasonably
acceptable to WU. SIGA will keep WU informed of all proceedings and
provide copies of all pleadings and other papers related to such actions.
WU will provide reasonable assistance to SIGA in prosecuting any such
actions.
8.4 SIGA at its sole expense will defend third party claims of patent or
intellectual property infringement and injury, death or product liability
brought against SIGA and/or WU. SIGA will have the right to conduct the
defense of such actions through outside counsel of its choice who are
reasonably acceptable to WU. WU will provide all reasonable assistance for
the defense of such claims and SIGA will keep WU informed of all
proceedings and provide copies of all pleadings and other papers related
to such actions.
8.5 If more than one nonexclusive licensee participates in bringing or
defending an action under this Article, then the costs and fees for such
action will be shared pro-rata among such licensees.
8.6 Notwithstanding anything stated herein to contrary, SIGA will not be
permitted to settle or compromise any claim or action in a manner that may
impose restrictions or obligations on WU or grant rights or concessions to
Intellectual Property or Licensed Products without WU's prior written
consent.
8.7 SIGA will be entitled to offset 50% of its attorney's fees end expenses
incurred in abating third party infringement or unfair trade practices or
bringing or defending any action against third parties under this Article,
against the royalties due under Sections 4.4 and 4.5.
9. Indemnification. SIGA and its Sublicensees will indemnify, defend and hold
harmless WU, its trustees, faculty, staff, students and agents from and
against any and all liability, loss, damage, action, claim or expense
(including attorney's fees and costs at trial and appellate levels) in
connection with any claim, suit, action, demand or judgment arising out of
(a) the use of any Intellectual Property in the design, development,
production, manufacture, sale or offer for sale, use, importation, lease,
marketing or promotion of any Licensed Product by SIGA or its
Sublicensees, contractors or agents or (b) injury or death to any person,
or damage to property caused or allegedly caused by or relating in any way
to any person's use of any Licensed Products, or (c) any third party claim
that any use or licensing of the Intellectual Property under this
Agreement violates or infringes that party's intellectual property rights.
In legal actions undertaken or defended by SIGA pursuant to this
indemnification provision, SIGA may select counsel of its own choice who
are reasonably acceptable to WU.
10. Insurance.
10.1 SIGA and its Sublicensees will at all times comply, through insurance or
self-insurance, with all statutory workers' compensation and employers'
liability requirements covering all employees with respect to activities
undertaken in performance of this Agreement. This requirement may be met
by insurance or self-insurance coverage provided to SIGA by a Sublicensee.
10.2 In addition to the foregoing, SIGA and any Sublicensees as appropriate,
will at appropriate times obtain and maintain occurrence-based Broad Form
Comprehensive General Liability (BFCGL) insurance with a reputable and
financially secure insurance carrier(s) having at least an "A" rating and
an A.M. Best Class Size of at least X. Deviations from the rating or class
size must be approved in advance by WU. The BFCGL insurance will include,
among all other coverages standing in
such BFCGL policies, coverage for product liability and contractual
liability.
10.3 The Insurance will provide to SIGA or each Sublicensee minimum annual
limits of $2 million in liability insurance for the WU Licensed Products,
and list WU as an additional insured.
10.4 All policies will be purchased and kept in force during the term of the
Agreement.
10.5 SIGA or any Sublicensee as appropriate, will provide WU with a certificate
of insurance and will provide a complete copy of the insurance policy to
WU as soon as one becomes available and notices of subsequent renewals.
The certificates must provide that SIGA's carrier will notify WU in
writing at least thirty days prior to cancellation or material change in
coverage.
10.6 WU may periodically evaluate the adequacy of the minimum coverages of
insurance specified in this Article. WU reserves the right to require SIGA
to adjust the insurance coverages. The specified minimum coverages do not
constitute a limitation on SIGA's or its Sublicensees' obligation to
indemnify WU under this Agreement.
11. Termination.
11.1 SIGA may terminate this Agreement with or without cause on ninety days
written notice to WU. The license rights granted hereunder terminate at
the end of the ninety day period.
11.2 WU may terminate on thirty days written notice to SIGA upon breach by SIGA
of the Agreement. The termination becomes effective at the end of the
thirty day period unless SIGA has fully cured the breach within the thirty
days.
11.3 If SIGA enters bankruptcy or receivership, voluntarily or involuntarily,
all obligations of WU and all rights (but not obligations) of SIGA and
this Agreement terminate immediately without the need for either WU or
SIGA to take any action.
11.4 Upon termination of this Agreement for any reason, SIGA must return to WU
all Confidential Information (as defined in Article 6) received from WU
during the Term of this Agreement.
11.5 On termination by either Party for any reason, the license rights granted
to SIGA under Article 3 terminate when termination of the Agreement is
effective. SIGA's obligations to pay fees, royalties or other payments
accruing prior to termination survive termination.
12. Use of Names. Neither Party may use the name of the other for any
commercial, advertisement, or promotional purpose without the written
consent of the other.
13. Assignment or Pledge of Agreement. Neither this Agreement nor any portion
of it may be assigned by either Party to anyone else without the written
consent of the other Party, and such consent will not be unreasonably
withheld. Notwithstanding this, SIGA may assign the entire Agreement,
without WU's consent, to an entity that succeeds to substantially all of
its business or assets by way of merger, sale, acquisition or otherwise,
provided that the successor agrees in writing to assume all the
obligations and liabilities of SIGA to WU. The rights granted in this
Agreement may not be pledged in any way by SIGA or any Sublicensee to
secure any purchase, lease or loan.
14. Notice. Any required or permissive notice under this Agreement will be
sufficient if in writing and delivered personally, by recognized national
overnight courier, or by registered or certified mail, postage prepaid and
return receipt requested, to the address below and will be deemed to have
been given as of the date shown on the receipt if by certified or
registered mail, or the day following dispatch if by overnight courier.
If to WU:
Washington University
Center of Technology Management
Campus Box 8013
000 Xxxxx Xxxxxx Xxxxxx
Xx. Xxxxx XX 00000
If to SIGA:
Xxxxxx X. Xxxxxx
SIGA Pharmaceuticals, Inc.
000 Xxxxxxxxx Xxxxxx
Xxxxx 000
Xxx Xxxx, XX 00000
15. General Provisions.
15.1 This Agreement will be governed and interpreted according to the laws of
Missouri.
15.2 None of the terms of this Agreement can be waived except by mutual written
consent of the Parties.
15.3 This instrument comprises the entire agreement and understanding of the
Parties relating to the subject matter of the Agreement.
15.4 This Agreement cannot be changed, modified or amended except by a written
instrument subscribed by authorized representatives of the respective
Parties.
15.5 Neither Party is an agent or contractor of the other as a result of any
transaction under or related to this Agreement. Neither Party may in any
way pledge the other Party's credit or incur any obligation on behalf of
the other Party.
15.6 Each Party is liable to the other only for actual damages for breach of
this Agreement or any warranty contained herein, and not for any special,
consequential, incidental, or indirect damages arising out of this
Agreement, however caused, under any theory of liability.
15.7 The provisions of this Agreement are severable in that if any provision in
the Agreement is determined to be invalid or unenforceable under any
controlling body of law, that will not affect the validity or
enforceability of the remaining provisions of the Agreement.
15.8 If the performance of any obligation under this Agreement is prevented or
impaired by acts of war, riot, acts or defaults of common carriers, or
governmental laws or regulations, a Party will be excused from performance
so long as such cause continues to prevent or impair that Party's
performance. The Party claiming force majeure excuse must promptly notify
the other Party of the existence of the cause and must all times use
diligent efforts to resume and complete performance. This Section 15.8
will not excuse SIGA's obligation to pay fees, payments and royalties
under Article 4 of the Agreement
15.9 WU has no responsibility for product design and development, servicing,
distribution, or marketing, or any decisions made or strategies devised in
areas related to Licensed Products.
15.l0 Articles 4, 5, 6, 9, 10, and 12 above will survive expiration or
termination of this Agreement.
15.11 This Agreement will be executed in two original versions, one belonging to
each Party. The originals are valid counterparts of each other.
Witness: The parties have caused this Agreement to be executed in duplicate by
their duly qualified representatives.
For SIGA For WU:
/s/ Xxxxxx X. Xxxxxx /s/ Xxxxxx Neighbour
----------------------------------- -----------------------------------
Signature Signature
Name Xxxxxx X. Xxxxxx Name Xxxxxx Neighbour, Ph.D.
Title Chief Executive Officer Title Associate Vice Chancellor
For Technology Management
2/14/00 2/17/00
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Date Date
