Exhibit 10(s)
RESEARCH COLLABORATION AND LICENSE AGREEMENT
This Agreement, effective this 6th day of February ("Effective Date") by and
between The Washington University, 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, Xxxxx Xxxxx,
Xxxxxxxx 00000, through its School of Medicine, 000 X. Xxxxxx Xxxxxx, Xxxxx
Xxxxx, Xxxxxxxx 00000 ("WUSTL") and SIGA Pharmaceuticals, Inc., a corporation
duly organized and existing under the laws of the State of Delaware and having
its principal office at 000 Xxxxx Xxxxxx, 00xx Xxxxx, Xxx Xxxx, Xxx Xxxx 00000
("SIGA").
WHEREAS, WUSTL, through its research funded in part by WUSTL, and others, has
developed intellectual property comprising patent rights, copyrights, know-how
and technical data;
WHEREAS, WUSTL is the owner of such intellectual property rights which can be
applied to the Field of Use, defined below, and has the right to grant licenses
to such intellectual property rights;
WHEREAS, WUSTL desires to have such intellectual property rights commercialized
and used in the public interest so that the expected benefits of the resulting
products will be available to the public as soon as commercially reasonable;
WHEREAS, SIGA has represented to WUSTL that it has the necessary product
development capabilities and resources to reasonably attempt to introduce
commercial products based upon such intellectual property rights;
WHEREAS, based upon these representations by SIGA, WUSTL has decided that it
will grant a world-wide, exclusive, royalty-bearing license to SIGA to
commercialize the aforesaid intellectual property and SIGA agrees to license
this package of intellectual property and pay a sales royalty on the terms set
forth herein;
WHEREAS, the research program contemplated by this Agreement is of mutual
interest and benefit to WUSTL and SIGA, will further the instructional and
research objectives of WUSTL in a manner consistent with its non-profit,
tax-exempt status and academic missions, and may produce benefits for both WUSTL
and SIGA;
WHEREAS, this Agreement supersedes any Letter of Intent or proposals circulated
between SIGA and WUSTL;
NOW THEREFORE, the parties agree to the statements and representations made
above and to the following terms and conditions.
ARTICLE 1 - Definitions
For the purpose of this Agreement, the words and phrases set forth in this
Article will have the following meaning:
1.1 Agreement: This Research Collaboration and License Agreement.
1.2 Background Technology: The patents, patent applications, tangible materials
and proprietary compounds of WUSTL developed in the laboratory or under the
supervision of Xxxxx Xxxxxxxx, Ph.D. prior to the Effective Date of this
Agreement and listed in Appendix A.
1.3 Calendar Half: Each six (6) month period, or any portion thereof, beginning
on January 1 and July 1, after the Effective Date.
1.4 Combination Product: Any product that is comprised in part of a Licensed
Product and in part of one or more other biologically active diagnostic,
preventive or therapeutic agents which are not themselves Products (the "Other
Agents"). "Other Agents" excludes diluents and vehicles of Products.
1.5 Contract Year: The incremental period of time that this Agreement, or any
portion thereof, will be in force as measured from the first day of January
through the thirty-first day of December of the same calendar year, provided
that the first Contract Year will commence upon the Effective Date and conclude
December 31, 1998.
1.6 Field of Use: Anti-microbial compounds and compositions for all human and
veterinary diagnostic and therapeutic uses.
1.7 First Commercial Sale: The initial transfer of Licensed Products or
Combination Products for compensation by SIGA to an unrelated third party for
the purpose of commercial use and not for research, development or testing
purposes. Transfer of the Licensed Products for beta and field testing and
sampling will not constitute the First Commercial Sale. "First Commercial Sale"
does not include distribution of free promotional samples of any Licensed
Product or Combination Product by SIGA or any of its affiliates or sublicensees
in amounts determined to be commercially reasonable by SIGA in the exercise of
its reasonable discretion.
1.8 Inventions or Improvements: Any and all discoveries, methods, processes,
compositions of matter and uses, whether or not patentable, arising from
research activities supported by SIGA under this Agreement.
1.9 Licensed Products: Any composition of matter, product, article of
manufacture, apparatus, kit or component part thereof, or any similar item or
process, procedure or method that, when made, used or sold, would (i) be covered
by a pending claim contained in a patent application included in the Patent
Rights; (ii) infringe or contribute to the infringement of a valid
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and unexpired claim of a patent included in the Patent Rights; (iii) contain
Tangible Personal Property; and/or (iv) be covered by an unexpired claim of any
patent or patent application included in the Background Technology, or otherwise
incorporate, use or comprise Background Technology.
1.10 Net Sales:
(A) with respect to Licensed Products, the invoice price charged by SIGA to its
retail customers for the sale, lease or barter of Licensed Products, less:
(1) customary trade, quantity and cash discounts actually allowed and
taken; and,
(2) credits actually given for rejected or returned Licensed Products;
and
(3) freight and insurance costs, if separately itemized on the invoice
paid by the customer; and,
(4) value-added, sales, use or turnover taxes, excise taxes, tariffs
and customs duties included in the invoiced amount; and .
(B) with respect to Combination Products, the actual invoice price charged by
SIGA, less the deductions set forth in subsections (A)(1) - (4) above,
multiplied by a fraction having (i) a numerator of the gross sales price of the
Licensed Product(s) included in such Combination Product as if sold separately
or, if such sales price is not available, the fair market value of such Licensed
Product(s), and (ii) a denominator of the gross sales price of such Combination
Product, or if such sales price is not available, the sum of the fair market
values of the Other Agents and the Licensed Product(s) contained in such
Combination Product. The "fair market value" for any Licensed Product or Other
Agent shall be determined for a quantity comparable to that included in the
Combination Product and of substantially comparable class, purity and potency,
and shall be mutually agreed to by SIGA and WUSTL. When no fair market value is
available, the fraction set forth above shall be changed to a fraction having
(x) a numerator of the cost to SIGA or its affiliates or sublicensees of the
License Product(s) included in such Combination Product, and (y) a denominator
of the sum of such cost plus the cost to SIGA, or its affiliates or sublicensees
of the Other Agents contained in such Combination Product. "Cost" as used above
means the actual cost paid by SIGA and/or it affiliates or sublicensees in an
arm's length transaction, if purchased, or if not purchased but actually
manufactured by any such entity, the sum of the direct manufacturing cost as
determined by such entity's internal cost accounting system consistently
applied.
1.11 Patent Rights:
(A) the patents, patent applications and invention disclosures listed and more
fully described in Appendix B attached hereto and made a part hereof, and the
United States and foreign patents
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issuing from said pending patent applications and any continuations,
continuations-in-part, divisions, reexaminations, reissues, or extensions of any
of the foregoing; and
(B) any patents and/or patent applications covering any Invention or
Improvement, and the United States and foreign patents issuing from any such
patent applications and any continuations, continuations-in-part, divisions,
reexaminations, reissues, or extensions of any of the foregoing.
1.12 Project: Work funded by SIGA under annual research grants in accordance
with the research plan, for an initial term of three years, extendable as
provided below. Such work is further described in the attached Statement of Work
(Appendix C).
1.13 Project Participants: Xx. Xxxxx Xxxxxxxx, as Principal Investigator, and
any WUSTL employees and students working under his direction, and a Visiting
Scientist(s), working under the Principal Investigator's direction, in his
laboratory, on the Project, during the Term of this Agreement, with funding
provided by SIGA, as provided in this Agreement.
1.14 SIGA: SIGA Pharmaceuticals and its Subsidiaries.
1.15 Sublicensing Revenue: All gross revenues received by SIGA from sublicensees
for the manufacture, use or sale of Licensed Products anywhere in the world
during the Term of this Agreement, same to include by way of example and not
limitation: fees, licensing milestones, and cash equivalent value for
securities, equipment or other property received by SIGA as sublicensing
consideration from any sublicensee.
1.16 Subsidiaries: A corporation or other business entity controlled by SIGA.
For this purpose, control of a corporation or other business entity means direct
or indirect beneficial ownership of fifty-one percent (51%) or more of the
voting interest in, or a fifty-one percent (51%) or greater interest in the
equity of, such corporation or other business entity.
1.17 Tangible Personal Property: All physical embodiments of Patent Rights and
Technical Information, and all progeny and derivative works thereof.
1.18 Technical Information: All ideas, know-how, trade secrets, inventions,
discoveries, technical data, information, methods, materials, protocols,
formulations, arts, procedures or processes, whether or not patentable, owned by
or subject to the rights of WUSTL which are not in the public domain and which
are known by WUSTL and which WUSTL is free to disclose to SIGA, and which are
determined by SIGA to be useful in the practice of the Patent Rights.
1.19 Term: The Term of this Agreement will be from the Effective Date until the
expiration of the last of the patents included in the Patent Rights to expire,
unless terminated prior thereto by one of the parties in accordance with the
provisions of this Agreement.
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1.20 Visiting Scientist(s): The Visiting Scientist for the first full Contract
Half Year will be Xxx Xxxxx; the identity of the Visiting Scientist(s) for
Contract Years two and three (and any subsequent years) will be determined by
the mutual agreement of the parties. The Visiting Scientist shall not be deemed
an employee of WUSTL for purposes of this Agreement.
ARTICLE 2 - LICENSE GRANT
2.1 Grant of License. WUSTL hereby grants to SIGA a royalty-bearing, exclusive,
nontransferable license to make, have made, use, have used, sell, have sold,
distribute, import, export and lease License Products under Background
Technology, Patent Rights, Tangible Personal Property and Technical Information
in the Field of Use, throughout the world during the Term, unless sooner
terminated as hereinafter provided. SIGA will have the right to sublicense under
the license granted herein, subject to approval by WUSTL of the sublicensee, and
such approval will not be unreasonably withheld or delayed. No other license is
hereby granted or implied.
2.2 WUSTL agrees that any Invention(s) or Improvement(s) shall be disclosed
promptly to SIGA. Any such Invention(s) or Improvement(s) shall automatically be
added to SIGA's existing license grant under Section 2.1 hereof without the
payment of any additional consideration or any further action by either of the
parties hereto.
2.3 If SIGA (a) chooses by written notice not to practice any Patent Rights
licensed to it hereunder, or (b) notifies WUSTL in writing of its intent not to
add a particular new Invention or Improvement to the existing license, WUSTL
shall be free to license the same to a third party or parties of its choosing.
SIGA agrees to give WUSTL written notice of any decision (i) not to practice
Patent Rights as promptly as practicable or (ii) not to add a new Invention or
Improvement to the existing license within one hundred and fifty (150) days
after such Invention or Improvement is disclosed to SIGA .
2.4 WUSTL agrees to provide SIGA with Technical Information developed in the
Project from time to time during the term of this Agreement. SIGA shall be
entitled to use (and shall be entitled to allow its affiliates and sublicensees
to use) such Technical Information internally in support of development,
discovery, manufacturing and marketing efforts for sales of Licensed Products
and otherwise as contemplated by this Agreement. The provision of such Technical
Information by WUSTL to SIGA shall be subject to the confidentiality
requirements contained in Article 7.
2.5 Reservation of Rights by WUSTL. Notwithstanding WUSTL's grant of an
exclusive license pursuant to Section 2.1, WUSTL reserves the right to use the
Patent Rights, Technical Information, Background Technology and Tangible
Personal Property for internal, non-commercial research and educational purposes
only. All rights not specifically granted to SIGA pursuant to this Agreement
shall be retained by WUSTL.
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ARTICLE 3 - DILIGENCE
3.1 Reasonable Efforts. SIGA will use commercially reasonable efforts to
develop, promote demand for and sell Licensed Products. SIGA will, within one
hundred and twenty (120) days of the Effective Date, use reasonable efforts to
determine whether SIGA will fund a laboratory to provide chemical synthesis
capability to support the development of Licensed Products concurrently with its
research funding to WUSTL during the Project.
3.2 Product Development Plan. Within one hundred and twenty (120) days after
identification of a target molecule as a Licensed Product, SIGA will submit a
Product Development Plan ("Plan") to WUSTL for each such Licensed Product. The
Plan will set forth SIGA's good faith estimate of the primary tasks and schedule
for the development of specific Licensed Products by SIGA and the estimate of
production and sales of each Licensed Product for the next five (5) Contract
Years. The Plan and any updates thereto will contain the following minimum data:
(A) Definition/specification of each Licensed Product planned for development;
(B) Tasks to be performed by SIGA, its subcontractors, WUSTL and others to
develop each Licensed Product including estimated time schedules for prototype
development, subsystems development, beta testing, clinical trials, product
development, market testing, as relevant;
(C) Tasks to be performed to achieve regulatory approval or other certification
of each Licensed Product including estimated time schedule;
(D) Good faith estimate of First Commercial Sale of each Licensed Products by
country in North America, Europe, and Asia/Pacific Basin;
(F) Good faith estimate of sales and income by Calendar Half for the following
five (5) Contract Years.
3.3 Plan Updates. SIGA will update and report progress against the Plan in
writing to WUSTL thirty (30) days after the close of each Calendar Half to be
submitted concurrently with Calendar Half reports and Product Development Plan
updates. SIGA will notify WUSTL of any changes in the Plan within a reasonable
time period after the occurrence of or recognition of the need for such changes.
Upon request by WUSTL, SIGA will consult with WUSTL concerning tasks, schedules
and progress.
3.4 Diligence Prior to First Commercial Sale. Prior to the First Commercial Sale
of each Licensed Product, SIGA will be considered to be diligent with regard to
development of such Licensed Product so long as SIGA updates and reports
progress against the Plan and so long as SIGA:
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(A) Continues to provide the necessary financial and other resources which are
required to maintain progress in accomplishing the Plan, as it relates to each
Licensed Product, including paying required maintenance fees;
(B) Conducts and/or enables others to conduct the activities required to
maintain scheduled progress in accomplishing the Plan, as it relates to each
Licensed Product; and,
(C) Provides research funding to WUSTL during the first three Contract Years as
provided, inter alia, in Section 4.2, below.
3.5 Lack of Diligence. Should WUSTL reasonably determine in good faith that SIGA
is not diligent in development or sales of a Licensed Product based upon the
criteria set forth in Sections 3.1, 3.3, or 3.4 as applicable, for any reason
other than
(A) the withholding by a regulatory agency of marketing approval despite SIGA's
diligent effort to obtain such approval;
(B) unanticipated technical or scientific problems which have been previously
and promptly reported to WUSTL; or
(C) other causes beyond the reasonable control of SIGA which have been
previously and promptly reported to WUSTL, including without limitation the
failure of WUSTL to perform under the Plan; then
WUSTL may give notice to SIGA stating the basis for its conclusions and, upon
request of WUSTL, SIGA will show cause why the license granted for such Licensed
Product should not be terminated with respect to that Licensed Product. If
within ninety (90) days after SIGA's receipt of said notice, the parties have
not resolved the matter through good faith negotiations in a mutually acceptable
manner, the parties shall submit the matter to arbitration in accordance with
Article 12.
3.6 Grant of Option to Applications and Markets. WUSTL may present proposals to
SIGA for development of products for applications and/or markets that are not
being actively pursued by SIGA at the time of presentation. SIGA will have 90
days after submission of such a proposal to declare interest in writing in the
proposal and in developing a competitive plan to address the application and/or
market. SIGA will have an additional 120 days from the declaration of interest
to provide a competitive plan to WUSTL. If SIGA fails to declare interest, or
fails to provide a competitive plan after a declaration of interest, then in
either case this option will expire and WUSTL will have the right to license
others in that specific field of use.
ARTICLE 4 - PAYMENTS
4.1 License Issue Fee. Upon the Effective Date of this Agreement SIGA will pay
to WUSTL
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a non-refundable, noncreditable License Issue Fee of $ *.
4.2 Research Funding. Subject to Section 5.3, for the first two full Contract
Years that this Agreement is in effect, SIGA will provide annual research grants
in accordance with the attached Research Plan (Appendix D), incorporated by
reference herein, said funding to include the full salary and benefits for a
Visiting Scientist(s) to work in the laboratory of the Principal Investigator,
under his supervision, on the Project, in the Field of Use. No less than ninety
(90) days before the end of the second Contract Year both parties will evaluate
the scope of work for the third Contract Year and will negotiate a new research
budget for that year, said budget will not be less than $ *.
4.2.1 In addition to the funding that SIGA will provide in accordance with
Appendix D, SIGA will purchase up to $ * of laboratory equipment that will be
loaned to WUSTL for the duration of the research period. At the end of the
research period, or if the Agreement is terminated prior thereto, SIGA will give
the equipment to WUSTL, at no cost to WUSTL. The Principal Investigator will
identify equipment to be purchased and provided and SIGA will buy the equipment
in a timely manner and also deliver in a timely manner the equipment to WUSTL.
4.3 Annual License Maintenance Payments. SIGA will pay WUSTL $ * in Contract
Year Two, $ * in Contract Year Three and $ * per year each year of the Term
after research funding has terminated until the First Commercial Sale has taken
place, said payment due and payable by January 15 of each Contract Year to which
it applies. Such payment shall be pro rated for the year in which the First
Commercial Sale takes place and any balance due SIGA shall be applied Earned
Royalties (as defined below).
4.4.1 Performance Milestone Payments. Subject to Section 5.3, SIGA will pay the
following milestone payments with respect to the first discrete molecule which
is a Licensed Product under the terms of this Agreement according to the
following schedule:
(A) Commencement of a formal preclinical development program: $ *;
(B) Submission of first investigative new drug (IND) application to the
U.S. Food and Drug Administration (the "FDA"): $ *;
(C) Completion of first Phase I trials under the IND: $ *;
(D) Commencement of first Phase III trials under the IND: $ *; and
(E) Obtaining new drug approval (NDA) from the FDA: $ *.
For any additional discrete molecules which are Licensed Products under the
terms of this
* Confidential information is omitted and filed separately with the SEC.
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Agreement, SIGA will pay milestone payments according to the above schedule and
such milestone payments will be prorated (except for the NDA milestone payment)
thus: *% second, *% third, *% fourth, *% fifth, *% sixth, and *% for each
subsequent milestone payment. The NDA milestone is $ * for each occurrence with
no proration.
4.4.2 Diligence Milestone Payments. Subject to Section 5.3, and only in the
event that no milestone payment has been, or has been required to be, made by
SIGA pursuant to Section 4.4.1, SIGA will pay the following milestone payments,
according to the following schedule, to avoid termination of the agreement:
(A) Contract Year Four, or the first year following termination of
research funding: Milestone payment of $ *;
(B) Contract Year Five or the second year following termination of
research funding: Milestone payment of $ *;
(C) Contract Year Six or the third year following termination of research
funding: Milestone payment of $ *;
(D) Contract Year Seven or the fourth year following termination of
research funding: Milestone payment of $ *;
(E) Contract Year Nine or the sixth year following termination of research
funding: Milestone payment of $ *.
4.4.3 The milestone payments made by SIGA under Sections 4.4.1 or 4.4.2 are *%
cumulatively creditable against Earned Royalties (as defined below), with such
credit limited to *% of Earned Royalties for any given Contract Year, with
credits actually taken deducted from the accumulated balance of creditable
milestone payments.
4.5 Milestone payments will be due within thirty (30) calendar days following
the Calendar Half commencing immediately after occurrence of the milestone event
applicable to each.
4.6 Earned Royalties. In consideration for the license grants of Article 2, SIGA
will pay to WUSTL, an earned royalty ("Earned Royalty") of
* % of the Net Sales of each Licensed Product or Combination Product in each
country where the Licensed Product or Combination Product, when made, used, or
sold is covered by a patent or patent application in Background Technology or
Patent Rights. This provision expires on a country by country basis upon the
expiration of any such patents in that country; and
* Confidential information is omitted and filed separately with the SEC.
*% of the Sublicensing Revenue.
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For the purpose of this Agreement, the date of sale will be the date SIGA takes
revenue credit in its sales accounting records or upon actual receipt of the
proceeds of said sale, lease or barter, whichever is earlier.
4.6.1 In the event that SIGA enters into a license agreement with any third
party to avoid or settle a claim of infringement of any intellectual property
right made by such third party due to SIGA's use of Background Technology,
Patent Rights, Technical Information or Tangible Personal Property, SIGA may
offset *% of any royalty payment made in accordance with any such license
agreement against the Earned Royalties owed WUSTL under 4.6 of this Agreement,
provided, however, that in no event shall the Earned Royalties otherwise due to
WUSTL be reduced by more than *% of the Earned Royalties owed to WUSTL in any
given Calendar Half as a result of the application of this Section 4.6.1. If
SIGA settles any such claim of infringement by making a cash payment to a third
party, provided that SIGA receives the prior approval of WUSTL, which shall not
be unreasonably withheld or delayed, then SIGA may reduce Earned Royalties by *%
until all of such payment is recovered.
4.7 Minimum Annual Royalties. Minimum annual Earned Royalties ("Annual Minimum
Royalties") will be $ * per Contract Year commencing with the First Commercial
Sale. The non-refundable Annual Minimum Royalties payable to WUSTL by SIGA
hereunder are fully creditable against Earned Royalties. In the event that
Earned Royalties for any Contract Year are less than the Annual Minimum
Royalties specified herein, SIGA will pay the difference between the Annual
Minimum Royalties required and actual Earned Royalties with its final royalty
payment for the respective Contract Year. Annual Minimum Royalties are not
cumulative and any credit for Annual Minimum Royalties may not be carried
forward to future Contract Years.
4.8 Payment. Annual Minimum Royalties and Earned Royalties will be payable for
the full term of the license grant in United States Dollars by electronic
transfer to a bank account designated by WUSTL. The rate of exchange will be
that in effect at the Chase Manhattan Bank on the last business day of each
Calendar Half such payments are due.
4.9 Calendar Half Payments. Earned Royalties will be accumulated and reported on
a Calendar Half basis. Payment will be made thirty (30) days following the close
of such Calendar Half periods with Annual Minimum Royalties applied and paid
with the final Calendar Half Earned Royalty payment for that Contract Year.
Unless otherwise specified in this Agreement, SIGA's payment for any other
charges due WUSTL hereunder will be made within thirty (30) days following
SIGA's receipt of WUSTL's invoice for same.
4.10 Patent Expense. SIGA will reimburse up to $* of any as-yet unreimbursed
WUSTL Background Technology and Patent Rights patent application preparation and
prosecution expense and issue and maintenance fee costs incurred prior to the
date of this Agreement.
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4.11 Late Payments. Interest at prime (as published by Chase Bank) plus 2% will
accrue on the outstanding balance of any payment under this Article IV for the
period that payment is due until the time payment is actually received. Such
interest will be calculated by the actual number of days elapsed based on a 365
day year.
ARTICLE 5 - Research Work
5.1 The work to be performed by the Project Participants will be carried out in
accordance with the Statement of Work attached hereto. WUSTL and Project
Participants will use reasonable efforts to perform the Project work
substantially in accordance with the terms and conditions of this Agreement.
Anything in this Agreement to the contrary notwithstanding, WUSTL and SIGA may
at any time amend the Statement of Work by mutual written agreement.
5.2 To optimize the mutual benefit and collaboration intended by this Agreement,
the parties desire that there be mutually productive and continuing interchange
between the Project Participants and SIGA scientists. SIGA has named Xxxxxx X.
Xxxxx, Ph.D. as Research and Development Contact who will be responsible for the
conduct of SIGA research and development activities, coordination of reports and
information exchange and early identification of intellectual property of
commercial interest to SIGA.
5.3 During the term of the Project, Xx. Xxxxx Xxxxxxxx, the Principal
Investigator, will not collaborate with any other commercial entity in any area
related to the Background Technology, Patent Rights or work funded by SIGA. In
the event Xx. Xxxxxxxx is unavailable or unable to continue the Project at
WUSTL, for any reason, SIGA will have the option to terminate the Project. If
SIGA exercises its option to terminate the Project pursuant to this Section 5.3,
then SIGA shall only be obligated to make payments to WUSTL under Sections 4.3,
4.6 and Article 10 shall not be obligated to make any other payments to WUSTL
under this Agreement; provided, however, that if SIGA is developing a Licensed
Product, then SIGA shall be obligated to make payments to WUSTL under Section
4.4.1. Termination of the Project will not terminate this Agreement or any
rights granted hereunder to SIGA.
5.4 WUSTL and Project Participants will make reasonable efforts to perform the
Project, but make no assurances that the effort will be a complete success.
ARTICLE 6 - TECHNICAL REPORTS AND CONFERENCES
6.1 To keep SIGA informed of the progress of the Project, the Principal
Investigator agrees to make informal verbal reports once a month, provide
quarterly written reports to SIGA within fifteen (15) days of the end of each
quarter, detailed written reports annually, within thirty (30) days of the end
of each Contract Year, and a final written report within sixty (60) days of the
end of the Project. In addition, the Principal Investigator agrees to meet with
SIGA Research and Development Contact upon reasonable request at WUSTL's
facilities to discuss the progress of the Project work. SIGA will be responsible
for all expenses of SIGA personnel relating to these
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conferences. The Principal Investigator may travel to SIGA facilities or
facilities of a third party academic research lab retained and supported by SIGA
to provide chemical synthesis expertise, on timely and reasonable request of
SIGA, at SIGA's expense, in a manner not inconsistent with WU faculty policies
including those on tenure, academic freedom, responsibility, and consulting
privileges.
6.2 SIGA's Research and Development Contact will keep the Principal Investigator
informed of all collaborative activities conducted by SIGA in support of the
Project, in particular, SIGA's test results of all Tangible Personal Property
provided to SIGA by WUSTL, the Principal Investigator, or the other Project
Participants during quarterly research meetings and in writing following the end
of each Calendar Half.
ARTICLE 7 - CONFIDENTIALITY
7.1 General. All proprietary information owned by SIGA and provided to WUSTL,
and all proprietary information owned by WUSTL and provided to SIGA, under this
Agreement and marked "Confidential" will be deemed "Confidential Information".
Each party agrees to xxxx only such proprietary information as "Confidential"
which such party believes in good faith to be confidential.
(A) Both parties agree to protect and keep secret Confidential Information until
the termination of this Agreement or ten years from the Effective Date of this
Agreement, whichever is later. SIGA may disclose Confidential Information only
to third parties in confidence as necessary for making, having made, using,
having used, selling, having sold, distributing, importing, exporting and
leasing Licensed Products. Both parties agree not to use any Confidential
Information for any purpose other than for the purpose of this Agreement.
(B) WUSTL will instruct its faculty and each non-faculty status individual
engaged in performance under this Agreement that prior to receipt of any SIGA
Confidential Information they may be required to execute a personal
confidentiality agreement with SIGA, obligating such individual to maintain SIGA
Confidential Information in confidence and not use such SIGA Confidential
Information for any purpose other than in accordance with the terms and
conditions of this Agreement. WUSTL will not be party to any such
confidentiality agreement, nor will WUSTL have any obligation for the
enforcement of any such agreement on behalf of SIGA.
7.2.1 Exceptions. Notwithstanding the foregoing, the confidentiality obligations
herein will not apply to any Confidential Information which:
(A) Is or becomes generally available to the public through no fault of SIGA or
its employees or agents (including, but not limited to, publication in trade or
academic journals, or presentation at a trade or academic seminar, meeting, or
similar events open to the general academic or trade community);
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(B) Is published or disclosed by WUSTL, its faculty, employees, or agents to the
general public, in accordance with Article 14 if applicable (including, but not
limited to, publication in trade or academic journals, or presentation at a
trade or academic seminar, meeting, or similar events open to the general
academic or trade community);
(C) Is disclosed to SIGA by a third party having the lawful right to disclose
same, without obligation of confidentiality to WUSTL, or its consultants or
agents;
(D) Is disclosed by SIGA to a government agency to comply with statutory
requirements for market approval, clinical trials, certification, manufacture
and/or distribution of the Licensed Products, for which SIGA is unable to
lawfully secure confidentiality;
(E) Is approved for release by the party owning such Confidential Information,
and then only to the extent such written approval is granted by such party; or
(F) Is disclosed pursuant to an order of a court of competent jurisdiction.
7.2.2 Material Transfer Agreement. It will not be a breach of this Agreement for
either party to transfer any Confidential Information to a third party for such
third party's internal research use only pursuant to the terms of the jointly
approved material transfer agreement attached hereto as Appendix E. There will
be no deviation from the terms of this material transfer agreement without
written agreement by both parties in each instance in which a deviation is
sought. Each party will inform the other party of all material transfer
agreements it enters into with third parties by providing the other party of a
copy of the fully executed material transfer agreement within thirty (30) days
of final execution thereof.
7.3 Confidentiality of Agreement. Each party further agrees that the terms and
conditions of this Agreement will be treated as Confidential Information except
as required by or for applicable disclosure laws, financing sources, enforcement
of the Agreement, mergers and acquisitions, or as otherwise mutually agreed by
the parties, such agreement will not be unreasonably delayed or withheld.
ARTICLE 8 - Representations and Warranties
8.1 General. WUSTL warrants to its best knowledge and belief on the Effective
Date that:
(A) It is the owner of intellectual property licensed and the Tangible Personal
Property; and
(B) As of the Effective Date of this Agreement, the Background Technology and
the Patent Rights are free of any liens, encumbrances, restrictions and other
legal or equitable claims against WUSTL, except as noted in Section 8.3, below.
8.2 Authority. Each party represents and warrants that it has the right and
authority to enter
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into this Agreement.
8.3 Conflicts. Each party represents and warrants that the making of this
Agreement does not violate any separate agreement it has with any other person
or entity. The parties acknowledge that the U.S. Government may have rights to
inventions of Background Technology and Patent Rights by operation of law.
8.4 Exceptions. Notwithstanding any provisions of this Agreement, the Parties do
not:
(A) Warrant or represent that anything made, used, sold or otherwise disposed of
under any license granted in this Agreement is or will be free from infringement
of any patents or other proprietary rights of third parties, nor warrants the
validity of the scope of the patents included in the Patent Rights;
(B) Grant rights to WUSTL to use the name of SIGA or any of its employees or
subcontractors in advertising, publicity or otherwise without the prior written
approval of SIGA, which will not be unreasonably withheld; or
(C) Grant rights to SIGA to use the name of WUSTL or its employees in
advertising, publicity or otherwise without the prior written approval of WUSTL,
which will not be unreasonably withheld. It will not be unreasonable for WUSTL
to withhold such consent if, in WUSTL's opinion, such use can be construed as
any form of commercial endorsement.
8.5 Disclaimer. WUSTL 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 LICENSED PRODUCTS FOR A PARTICULAR PURPOSE.
8.6 No Recourse. Neither party will have any recourse against the other for any
loss, liability, damage, or costs which may be suffered or incurred by utilizing
any of the rights or licenses granted by this Agreement. Neither party will have
any liability or recourse against the other arising from any lawsuit brought
against one of the parties by reason of its exercise of rights under this
Agreement.
ARTICLE 9 - FINANCIAL RECORDS AND REPORTS
9.1 Records. SIGA will keep full, complete and accurate books of account
containing all particulars which may be reasonably necessary for determining the
royalties payable to WUSTL. Said books of account will be kept at SIGA's
principal place of business or the principal place of business of a division of
SIGA which is marketing Licensed Products.
9.2 Audit. Said books and particulars of Section 9.1 will be available during
normal business hours, upon reasonable notice, for two (2) years following the
end of the calendar year to which
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they pertain, for inspection by an independent certified public accountant
retained by WUSTL at WUSTL expense, for the purpose of verifying SIGA royalty
statements. SIGA will require its Subsidiaries to comply in like manner with the
requirements of Section 9.1. In the event that SIGA's royalties calculated for
any period are in error to the detriment of WUSTL by greater than five percent
(5%), the reasonable cost of the audit and review will be borne by SIGA.
9.3 Reports. Concurrently with the payments required by Section 4.6 and the
Product Development Plan Updates of Section 3.2, SIGA will deliver materially
true and accurate royalty and revenue reports to WUSTL within thirty (30) days
after the end of each Calendar Half, giving such particulars of the business
conducted by SIGA during the preceding quarter as are pertinent to a royalty
accounting under this Agreement.
(A) The quantity and types of Licensed Products made, used or sold, on a country
by country basis;
(B) Total Net Selling Price for Licensed Products sold and total fair market
value for Licensed Products bartered;
(C) Allowances and adjustments used to calculate Net Sales;
(D) Total royalties due for each Licensed Product;
(E) Name(s) and addresses of all Subsidiaries and Sublicensees.
9.4 Third Party Reports. SIGA will provide WUSTL one copy of all research,
marketing, product development, product tests, or other evaluations for use by
WUSTL in connection with the Project.
ARTICLE 10 - PATENT PROSECUTION AND ENFORCEMENT
10.1 Applications. WUSTL will select qualified independent patent counsel
reasonable satisfactory to SIGA to file, prosecute and maintain Background
Technology and Patent Rights patents and patent applications. SIGA will take all
actions necessary to cooperate with and assist WUSTL in the prosecution and
maintenance of Background Technology and Patent Rights patent applications and
patents. Prosecution and maintenance fees and expenses will be borne by SIGA.
WUSTL will keep SIGA informed as to the status of patents and patent
applications included in the Background Technology and Patent Rights by
providing SIGA with copies of all written communications with the patent offices
and associated outside counsel and consulting SIGA on responses to the patent
offices in advance of submission. Should WUSTL decide not to finance the
preparation, filing, prosecution, or maintenance of any patent application or
patent licensed hereunder, WUSTL will give notice to SIGA of such decision in
writing in adequate time to allow SIGA at its own cost, to effectuate such
preparation, filing, prosecution, or maintenance if it desires to do so. Nothing
herein is intended or shall be construed as obligating
15
SIGA to maintain its license with respect to any patent or application licensed
hereunder and to finance the preparation, filing, prosecution or maintenance of
any patent application in any country or jurisdiction in which it believes it is
not in the best business interest of SIGA to do so.
10.2 Enforcement. WUSTL and SIGA will each give immediate written notice to the
other of any suspected infringement of patents included in the Background
Technology or Patent Rights or unauthorized use of Background Technology or
Tangible Personal Property by third parties. SIGA, at SIGA expense, will attempt
to xxxxx infringement or unauthorized use by third parties, and SIGA has the
right to institute and conduct such legal action against third party infringers
of patents included in the Background Technology or Patent Rights and/or
unauthorized users of Background Technology and Tangible Personal Property, or
enter into such settlement agreements, as deemed appropriate by SIGA; provided,
however, that WUSTL will not be bound by any such settlement agreements without
its prior approval, which will not be unreasonably withheld or delayed.
ARTICLE 11 - INDEMNIFICATION AND INSURANCE
11.1 Indemnification. SIGA will indemnify, defend and hold harmless WUSTL, its
trustees, officers, faculty, staff and students, against any claims, liability,
damage, loss or expense incurred by or imposed upon WUSTL in connection with any
claims, suits, actions, demands or judgments arising out of (i) the design,
production, manufacture, sale, use in commerce, lease, barter, or promotion by
SIGA, its Sublicensees or agents of any Licensed Product, process or service
relating to or developed pursuant to this Agreement by SIGA; or (ii) any other
activities to be carried out pursuant to this Agreement by SIGA.
11.2 SIGA will at all times comply, through insurance or self-insurance, with
all statutory workers' compensation and employers' liability requirements
covering any and all employees with respect to activities performed under this
Agreement. This insurance requirement may be fully met by insurance or
self-insurance coverage provided to SIGA by a Sublicensee of SIGA.
11.3 SIGA shall, as commercially reasonable and at appropriate times, purchase
liability insurance, which is appropriate as determined by industry standards,
from a reputable insurance company in the following amounts with respect to the
following activities:
(A) Licensed Products relating to laboratory research products and
laboratory screening: $ * million per occurrence and $ * million in the
aggregate.
(B) Licensed Products relating to in vitro human diagnostic test
products and services and human clinical trials: $ * million per occurrence
and $ * million in the aggregate.
(C) Licensed Products relating to human therapeutic products and/or
human prophylactic products: $ * million per occurrence and $ * million in
the aggregate.
* Confidential information is omitted and filed separately with the SEC.
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As to insurance for Licensed Products relating to human therapeutic and/or
human prophylactic products, their manufacture, marketing, distribution, sale or
use, such insurance shall be carried by SIGA for a period of ten (10) years
after (i) the date of the last commercial sale of the Licensed Products (on a
Licensed Product-by-Licensed Product basis), or, (ii) the termination or
expiration of this Agreement, whichever occurs later.
11.4 SIGA will provide WUSTL with a certificate of such insurance on an annual
basis, and will provide a complete copy of such insurance policy to WUSTL as
soon as one becomes available. No policies of insurance may be canceled or
materially revised without thirty (30) days prior written to WUSTL. Each policy
will be endorsed to incorporate this requirement relating to notice.
11.5 Prior to First Commercial Sale of any Licensed Product, process, or service
relating to, or developed pursuant to this Agreement, SIGA will at its sole cost
and expense procure and maintain policies of comprehensive general liability
insurance in amounts not less that $* per incident and $* annual aggregate.
WUSTL will be named as co-insured on the face of the insurance policy. Such
comprehensive general liability insurance will provide broad form contractual
liability coverage for SIGA's indemnification under this Agreement. The minimum
amounts of insurance coverage required under this Article 11 will not be
construed to create a limit of SIGA's liability with respect to its
indemnification hereunder.
ARTICLE 12 - ARBITRATION
12.1 Arbitration. Any dispute or claim arising out of this Agreement, that
cannot be settled by and between the Parties to their mutual satisfaction within
a reasonable period of time, will be submitted to binding arbitration in St.
Louis, Missouri under the Commercial Arbitration Rules of the American
Arbitration Association by one arbitrator appointed in accordance with said
Rules. The arbitrator will apply Missouri law to the merits of any dispute or
claim, without reference to rules of conflicts of law. Such arbitrator shall be
an attorney who is admitted to the Missouri State Bar and is experienced in
commercial litigation. The arbitrator so selected shall schedule a hearing on
the disputed issues within forty-five (45) days after his/her appointment and
the arbitrator shall render a decision after the hearing, in writing, as
expeditiously as is possible, which shall be delivered to the parties. The
arbitrator shall render a decision based on written materials supplied by the
parties to the arbitration in support of their respective oral presentations at
the hearing. The parties shall supply a copy of any written materials to be
submitted to the arbitrator at least fifteen (15) days prior to the scheduled
hearing. A default judgment may be entered against a party who fails to appear
at the arbitration hearing. Such decision and determination shall be final and
unappealable and shall be filed as a judgment of record and be enforceable in
any jurisdiction designated by the successful party. The parties to this
Agreement agree that this Section has been included to rapidly and inexpensively
resolve any disputes between them with respect to the matters described above,
and that this Section shall be grounds for dismissal of any court action
commenced by any party with respect to a
* Confidential information is omitted and filed separately with the SEC.
17
dispute arising out of such matters.
ARTICLE 13 - Termination
13.1 Bankruptcy. In the event that SIGA is the subject of a voluntary or
involuntary petition for relief under the United States Bankruptcy Code, or if
the business of SIGA will be placed in the hands of a receiver, trustee or
assignee for the benefits of creditors, where by the voluntary act of SIGA or
otherwise and such proceeding, if involuntary, is not vacated or terminated
within sixty (60) days after its commencement, this Agreement and the licenses
and all other rights granted to SIGA herein immediately will be deemed
terminated.
13.2 Payment Default. Should SIGA default in its timely payment of royalties or
any other payments or charges, WUSTL will have the right to serve notice upon
SIGA of its intention to terminate this Agreement within ninety (90) days after
receipt of said notice of termination unless SIGA will cure such default within
the ninety (90) day period. If SIGA has not paid all such royalties or other
charges due and payable within said ninety (90) day period and or cured its
default, the rights, privileges licenses and options granted hereunder will
terminate immediately upon receipt of written notice thereof from WUSTL. If the
amount of royalties or other payments due to WUSTL is contested by SIGA, the
rights, privileges and license granted hereunder will terminate ninety (90) days
after the resolution of such dispute, upon written notice by WUSTL, if the
amount due remains unpaid at the end of such ninety (90) day period.
13.3 Material Breach. Upon any material breach by SIGA of any material provision
of this Agreement, except as contemplated by Sections 13.1 and 13.2, WUSTL will
have the right to terminate this Agreement and the rights, licenses and options
granted hereunder upon receipt of ninety (90) day's prior written notice of
termination to SIGA by WUSTL. Such termination will become effective at the end
of such ninety (90) day period unless SIGA has cured such breach prior to the
expiration of the ninety (90) day period, or, SIGA has diligently commenced
reasonable efforts to effect such cure prior to the expiration of the ninety
(90) day period and diligently continues such efforts thereafter.
13.4 Termination by SIGA. SIGA may terminate this Agreement upon ninety (90)
day's notice by certified mail to WUSTL. The rights, privileges licenses and
options granted hereunder will terminate upon expiration of the ninety (90) day
period.
13.5 Obligations on Termination. Upon termination of this Agreement for any
reason SIGA will cease using Background Technology, Patent Rights and Tangible
Personal Property, provided that SIGA may complete the manufacture of Licensed
Product then in process and sell its remaining inventory of Licensed Products,
subject to the payment of royalties as set forth in Article 4 and reporting
requirements as set forth in Articles 6 and 9. However, nothing herein will be
construed to release either party of any obligation which matured prior to the
effective date of such termination. If termination of the Agreement occurs for
any reason before research funding has been terminated, then SIGA is obligated
to reimburse WUSTL for any non-
18
cancellable expenses associated with the Project for the remainder of the
Contract Year in accordance with the research plan.
13.6 Return of Tangible Personal Property. Upon termination of this Agreement
SIGA will return to WUSTL all Tangible Personal Property.
13.7 Survival. Articles 7, 11 and 12 and Section 13.5 will survive any
termination or expiration of this Agreement.
ARTICLE 14 - PUBLICATION
14.1 SIGA recognizes that under WUSTL policy, the results of WUSTL research must
be publishable and agrees that the Principal Investigator and Project
Participants will be permitted to present at symposia, national, or regional
professional meetings and to publish in journals, theses or dissertations, or
otherwise of their own choosing, methods and results of the Project. WUSTL
research personnel will at all times have the first opportunity to publish the
research results of the Project.
14.2 SIGA will be furnished copies of any proposed publication or presentation
in advance of the submission of such proposed publication or presentation to a
journal, editor, or other third party. SIGA will have thirty (30) days after
receipt of said copies to review said publication for patentable subject matter
which needs protection and/or is Confidential information of SIGA which requires
removal or revision. The parties will have an additional thirty (30) days (a
total of 60 days) to agree upon revisions to the publication in order to protect
SIGA Confidential Information. Further, publication may be withheld for an
additional thirty (30) days (a total of 90 days) in order for SIGA to file
patent application(s) with the United States Patent and Trademark office
directed to patentable subject matter contained in the proposed publication or
presentation. Upon the filing of a patent application, the material will be
released for publication.
ARTICLE 15 - Miscellaneous Provisions
15.1 Government Rights. The Federal Government may have certain rights to
Background Technology patents and Patent Rights by operation of law.
15.2 Personal Agreement. The license grants herein have been granted contingent
upon the personal relationship between the parties. This Agreement is personal
to the parties and may not be assigned by either party without the prior written
consent of the other party, except as to an assignment by SIGA in connection
with a sale of all or substantially all of its assets related to Licensed
Products.
15.3 Neither party will be deemed to be an agent of the other party as a result
of any transaction under or related to this Agreement, and will not in any way
pledge the other party's
19
credit or incur any obligation on behalf of the other party.
15.4 Notice. Any notice or other communication pursuant to this Agreement will
be sufficiently made or given on the date of mailing if sent to such party by
certified First Class mail, postage prepaid, addressed to it at its address as
first set forth in this Agreement, or as it will designate by subsequent written
notice given to the other party. Notices will be sent to:
If to WUSTL: Center of Technology Management
Campus Box 8013
000 X. Xxxxxx Xxx.
Xx. Xxxxx, XX 00000
If to SIGA: 000 Xxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000
15.5 Publicity. SIGA will not use the name of WUSTL, nor any faculty member or
employee of WUSTL, in any form of publicity, advertising, or news release
without the prior written approval of WUSTL, which will not be unreasonably
withheld or delayed.
15.6 Governing Law. This Agreement will be construed, governed, interpreted and
applied in accordance with the laws of the State of Missouri, USA, except that
questions affecting the construction and effect of any patent will be determined
by the law of the country in which the patent was granted.
15.7 Severability. The provisions of the Agreement are severable, and in the
event that any provision of this Agreement is determined to be invalid or
unenforceable under any controlling body of law, such invalidity or
enforceability will not in any way affect the validity or enforceability of the
remaining provisions hereof.
15.8 Integration. The Parties acknowledge that this instrument sets forth the
entire agreement and understanding of the parties hereto as to the subject
matter hereof, and will not be subject to any change or modification except by
the execution of a written instrument subscribed to by the parties hereto.
15.9 Force Majeure. WUSTL and SIGA will not be liable for any failure to perform
as required by this Agreement, to the extent such failure to perform is caused
by any reason beyond the control of WUSTL or SIGA, or by reason of a force
majeure event.
15.10 Export. SIGA will be responsible for obtaining appropriate licenses from
the Federal Government prior to the export of Tangible Personal Property or any
Licensed Products.
15.11 Amendment. This Agreement will only be amended by consent of both parties
expressed
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in writing and signed by both parties.
15.12 Headings. The headings are included for reference only and are not
intended to be a part of or to affect the meaning or interpretation of this
Agreement.
15.13 Sublicense. The parties agree that in the event of the termination of this
Agreement any sublicense granted hereunder shall be continued as a license
between WUSTL and the sublicensee on the terms and conditions of such sublicense
in effect at the time of any such termination.
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IN WITNESS WHEREOF, the Parties have hereunder set their hands and seals and
duly executed this Agreement in duplicate by its duly authorized officers the
day and year first above written.
THE WASHINGTON UNIVERSITY SIGA PHARMACEUTICALS, INC.
By: /s/ Xxxxxxxx X. Xxxxxx By: /s/ Xxxxx xx Xxxxx
------------------------------ ------------------------------
Name: Xxxxxxxx X. Xxxxxx Name: Xxxxx xx Xxxxx
Title: Vice Chancellor Research Title: Chairman and CEO
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