EXHIBIT 10(a)
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LICENSE AND RESEARCH SUPPORT AGREEMENT
BETWEEN THE COMPANY AND THE ROCKEFELLER UNIVERSITY
LICENSE AND RESEARCH SUPPORT AGREEMENT
AGREEMENT made as of the 31st day of January, 1996 by and between SIGA
PHARMACEUTICALS, INC. ("LICENSEE"), a corporation organized and existing under
the laws of the State of Delaware, having an office at 000 Xxxxx Xxxxxx, 00xx
Xxxxx, Xxx Xxxx, Xxx Xxxx, 00000 and THE ROCKEFELLER UNIVERSITY ("UNIVERSITY"),
a nonprofit education corporation organized and existing under the laws of the
State of New York, having an office at 0000 Xxxx Xxxxxx, Xxx Xxxx, Xxx Xxxx
00000.
W I T N E S E T H:
WHEREAS, XX. XXXXXXX X. XXXXXXXXX and his colleagues at the UNIVERSITY
together with colleagues at Emory University and Oregon State University, have
developed certain technology relating to vaccines and the development of
antibiotics, which technology is more fully described in the patents, and patent
applications listed in Exhibits "A-1" and "A-2" of this Agreement ("Core
Technology");
WHEREAS, LICENSEE wishes to obtain the exclusive license rights from the
UNIVERSITY to exploit the patents and patent applications covering the Core
Technology of which the UNIVERSITY is the sole owner (said patents and
applications being listed on Exhibit "A-1") and the exclusive grant from the
UNIVERSITY of its licensing rights to the patents and patent applications
covering the Core Technology of which the University is the co-owner (said co-
owned patents and applications being listed on Exhibit "A-2" attached);
WHEREAS, LICENSEE further wishes to sponsor continuing research by XX.
XXXXXXXXX and his colleagues at the UNIVERSITY in the area of the Core
Technology;
WHEREAS, the UNIVERSITY is willing to grant such license rights as provided
for herein in return for the research support, patent reimbursements and
LICENSEE'S other undertakings herein provided, all in the manner described
herein; and
WHEREAS, the research support herein described is of the essence of this
Agreement and any default in the prompt and full payment thereof in accordance
with the payment schedule herein provided shall be deemed a material breach of
this Agreement;
NOW, THEREFORE, in consideration of the mutual benefits to be derived
hereunder, the parties hereto agree as follows:
1. DEFINITIONS
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The following terms will have the meanings assigned to them below when
used in this Agreement:
1.1 "Affiliate" means, as to any person or entity, any other person or
entity which directly or indirectly controls, is controlled by, or is under
common control with such person or entity. For purposes of the preceding
definition, "control" means the right to control, or actual control of, the
management of such other entity, whether by ownership of voting securities, by
agreement, or otherwise.
1.2 "Combination Product" means any product that is comprised in part of a
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.
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1.3 "Commercial Sale" means any transfer to another person or entity
(including a distributor, wholesaler or sales agent), for value, after which
transfer the seller has no right, power or authority to determine the
transferee's resale price, if any. A transfer by LICENSEE to an Affiliate or
Sublicensee, or a transfer among or between Affiliates and/or Sublicensees,
shall not constitute a Commercial Sale. "Commercial Sale" does not include
distribution of free promotional samples of any Product or Combination Product
by LICENSEE or any of its Affiliates or Sublicensees in amounts determined to be
commercially reasonable by LICENSEE in the exercise of its reasonable
discretion.
1.4 "Party" shall mean either LICENSEE or UNIVERSITY and "Parties" shall
mean both LICENSEE and UNIVERSITY.
1.5 "Licensed Patent Rights" shall mean
(a) the patent(s), patent application(s) and invention disclosures set
forth in Exhibits "A-1" and "A-2" attached hereto and all patents which may
issue thereon, Exhibit "A-1" being those exclusively owned by the UNIVERSITY
and Exhibit "A-2" being those co-owned by the UNIVERSITY and Oregon State
University, in one instance, and by the UNIVERSITY and Emory University, in
another instance;
(b) any patent(s) and/or patent application(s) covering any Invention or
Improvement (as defined below) made in the course of research sponsored by
LICENSEE pursuant to Paragraph 5 hereof; and
(c) all patent applications and/or patents (including patents which may be
issued) which are divisionals, continuations, continuations-in-part, reissues,
renewals, reexaminations, substitutions, foreign counterparts, extensions or
additions of or to the patents and/or applications or are based upon the
invention disclosures described in (a) and (b) of this Paragraph 1.5.
1.6 "Core Technology" shall mean the technology described in the patents,
patent application(s) and invention disclosures set forth in Exhibits "A-1" and
"A-2", as the same may be expanded by Invention(s) or Improvement(s) added
thereto by operation of this Agreement.
1.7 "Invention(s)" or "Improvement(s)" shall mean any and all discoveries,
methods, processes, compositions of matter and uses, whether or not patentable,
made by XX. XXXXXXX XXXXXXXXX and/or his laboratory colleagues, conceived and
reduced to practice during the two-year term of research which is sponsored by
LICENSEE pursuant to the provisions of Paragraph 5 of this Agreement, or any
extension of such term of research sponsored by LICENSEE, which is agreed to by
the Parties.
1.8 "Technical Information" shall mean any and all technical data,
information, materials, trade secrets, methods, protocols, procedures,
formulations, arts and know-how, whether or not patentable, owned by or subject
to the rights of the University relating to the Core Technology during the term
of this Agreement which are determined by LICENSEE to be useful in the practice
of Licensed Patent Rights.
1.9 "Product(s)" means any product that is covered by a Valid Claim of the
Licensed Patent Rights. "Valid Claim", with respect to each country, means an
issued claim of any unexpired patent, or a claim of any pending patent
application that has not been held unenforceable, unpatentable or invalid by a
decision of a court or governmental body of competent jurisdiction, unappealable
or unappealed within the time allowed for appeal, which has not been rendered
unenforceable through disclaimer or otherwise, and which has not been lost
through an interference proceeding, in such country.
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1.10 "Net Sales" means:
(a) with respect to Products, the gross sales price actually charged by
LICENSEE or an Affiliate or Sublicensee in the Commercial Sale of such Licensed
Product, less:
(i) trade, prompt payment, quantity or cash discounts, rebates, and non-
affiliated brokers' or agents' commissions, each as actually and customarily
allowed and taken;
(ii) amounts actually repaid or credited to customers on account of
rejections or returns of specified products on which Royalties have been paid
hereunder or on account of retroactive price reductions affecting such products;
(iii) customary freight and other transportation costs, including
insurance charges, and duties, tariffs, sales, use and excise taxes and other
governmental charges based directly on sales, turnover or delivery of the
specified products and actually paid or allowed by LICENSEE, an Affiliate of
LICENSEE or a Sublicensee; and
(iv) commercially reasonable allowances for bad debts incurred with
respect to the Products during the first full year of Commercial Sales of any
such Product, provided that such bad debt reserve shall be deemed extinguished
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within 180 days of the end of such first full year, and any amount of such
reserve not actually debited in accordance with commercially reasonable
practices during that period shall be deemed to be receipts of Net Sales for all
purposes of this Agreement; and
(b) with respect to Combination Products, the gross sales price actually
charged by LICENSEE or an Affiliate or Sublicensee in the Commercial Sale of
such Combination Product, less the deductions set forth in subsections (a)(i) -
(iv) above, multiplied by a fraction having (i) a numerator of the gross sales
price of the 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 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 Product(s) contained in such
Combination Product. The "fair market value" for any 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 UNIVERSITY and LICENSEE. 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 LICENSEE, its Affiliates or Sublicensees,
of the Product(s) included in such Combination Product, and (y) a denominator of
the sum of such cost plus the cost to LICENSEE, its Affiliates or Sublicensees
of the Other Agents contained in such Combination Product, provided that in no
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event shall the fraction be less than (A) one-half (1/2), if only one Other
Agent is included with a Product(s) in such Combination Product, (B) one-third
(1/3), if two Other Agents are included with a Product(s) in such Combination
Product, and (C) one-quarter (1/4), if three or more Other Agents are included
with a Product(s) in such Combination Product. "Cost" as used above means the
actual cost paid by LICENSEE, 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 "Royalty" means for any given fiscal year of LICENSEE any sum payable
to the UNIVERSITY with respect to Net Sales in such fiscal year of Products or
Combination Products by LICENSEE, its Affiliates or Sublicensees, and shall
exclude without limitation any research or development support payments,
marketing or licensing fees received by LICENSEE or any Affiliate from any third
party, any equity investments received from any person or entity whatsoever, and
all other reimbursements, advances, prepayments or
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other payments received from third parties not specifically made with respect to
sales of Products or Combination Products.
1.12 "Sublicense" means any agreement pursuant to which LICENSEE or an
Affiliate of LICENSEE expressly grants to any third party the right to practise
the Inventions or Improvements included within the Licensed Patent Rights for
the purpose of manufacturing a Product which has not been produced by LICENSEE
or any of its Affiliates or provided to such third party by LICENSEE or any of
its Affiliates, and specifically excludes any marketing, sales, distribution or
similar arrangement with a third party; "SUBLICENSEE" means any person or entity
which is not an Affiliate of LICENSEE and to whom a Sublicense has been granted.
1.13 "Streptococcal A/Commensal Vaccine" means any product combining both
(a) the technology set forth in the UNIVERSITY'S patent application titled "THE
DELIVERY AND EXPRESSION OF A HYBRID SURFACE PROTEIN ON THE SURFACE OF GRAM
POSITIVE BACTERIA" and (b) the technology described in any one or more of the
following: (i) the UNIVERSITY'S patent titled "PRODUCTION OF STREPTOCOCCAL M
PROTEIN IMMUNOGENS"; (ii) the UNIVERSITY'S patent application titled
"RECOMBINANT POXVIRUS AND STREPTOCOCCAL M. PROTEIN VACCINE"; or (iii) the
UNIVERSITY'S patent application titled "SYNTHETIC PEPTIDES FROM STREPTOCOCCAL M
PROTEIN AND VACCINES PREPARED THEREFROM".
1.14 "Territory" shall mean the entire world.
2. LICENSED RIGHTS GRANTED
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2.1 The UNIVERSITY hereby grants to LICENSEE and its Affiliates a sole and
exclusive license, including the right to grant Royalty bearing Sublicenses
under terms consistent with this Agreement, subject only to the UNIVERSITY's
prior approval of Sublicensee selected by LICENSEE which approval shall not be
unreasonably withheld or delayed, under Licensed Patent Rights and Technical
Information, to make, have made, use, have used, sell, have sold and import
Products and Combination Products in the Territory, and to enter into marketing,
sales, distribution and similar agreements with third parties, except to the
extent that the UNIVERSITY'S right to do so may be limited
(a) under the provisions of 00 Xxxxxx Xxxxxx Code, Section 201,
et seq., and regulations and rules promulgated thereunder
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and implementing agreements thereof, or
(b) because the UNIVERSITY is only a co-owner of the the patents
and applications listed on Exhibit "A-2."
2.2 The UNIVERSITY agrees that any Invention(s) or Improvement(s)
made in the course of the research sponsored by LICENSEE, pursuant to Paragraph
5 hereof, shall be disclosed promptly to LICENSEE. The UNIVERSITY agrees that
Xx. Xxxxxxxxx shall provide LICENSEE with a quarterly research progress report
within thirty (30) days of the end of each calendar quarter after the date
hereof, which reports shall disclose any such Invention(s) or Improvement(s) to
LICENSEE, and a final research report containing customary detail and summaries
within sixty (60) days following the end of the research. Any such
Invention(s) or Improvement(s) shall automatically be added to LICENSEE'S
existing license grant under Section 2.1 hereof without the payment of any
additional consideration. The existing license shall automatically be expanded
to cover the new Invention(s) or Improvement(s) without any further action by
either of the Parties hereto, and said Invention(s) or Improvement(s) shall
thereupon be deemed an addition to the Core Technology under this Agreement.
2.3 If LICENSEE
(a) chooses not to practice any Licensed Patent Rights licensed
to it hereunder, or
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(b) notifies the UNIVERSITY of its intent not to add a particular new
Invention or Improvement to the existing license, the UNIVERSITY shall be free
to license the same to a third party or parties of its choosing.
LICENSEE agrees to give the UNIVERSITY prompt Notice of any decision
not to practice Licensed Patent Rights or not to add a new Invention or
Improvement to the existing license.
2.4 The UNIVERSITY agrees to provide LICENSEE with Technical
Information developed in XX. XXXXXXXXX'X laboratory at the UNIVERSITY from time
to time during the term of this Agreement. LICENSEE 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. The
UNIVERSITY further agrees to use its good faith efforts to cause Xx. Xxxxxxxxx
to promptly deliver clones or copies of the molecules, compounds, reagents or
other materials in his possession included in the Core Technology to LICENSEE
promptly from time to time upon LICENSEE'S request.
3. ROYALTIES AND OTHER LICENSE CONSIDERATION
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3.1 As further consideration for the license grant provided in
Paragraph 2.1, Licensee agrees to pay the UNIVERSITY the following amounts in
the nature of Royalties:
(a) Royalties on Net Sales of Products, as follows:
(I) For Products or Combination Products sold, leased or
otherwise disposed of by LICENSEE or any of its
Affiliates, Royalties equal to the following:
(A) For Streptococcal A/Commensal Vaccine:
(i) *****/1/ of Net Sales up to *****/1/;
(ii) *****/1/ of Net Sales above *****/1/ but
less than *****/1/; and
(iii) *****/1/ of Net Sales above *****/1/.
(B) For all other Products:
(i) *****/1/ of Net Sales up to *****/1/;
(ii) *****/1/ of Net Sales above *****/1/, but
less than *****/1/;
(iii) *****/1/ of Net Sales above *****/1/, but
less than *****/1/; and
(iv) *****/1/ of Net Sales above *****/1/.
(II) For Products or Combination Products sold, leased or
otherwise disposed of pursuant to a Sublicense by the
Sublicensee, the Royalty received by the UNIVERSITY
shall be equal to *****/1/ of the Royalty received by
LICENSEE from such Sublicensee, but in no event shall
the amount of such Royalty be greater than the amount
the UNIVERSITY would otherwise be entitled to receive
if such transaction were not a Sublicense, in which
case the University's
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1 Confidential information is omitted and identified by a * and filed
separately with the SEC pursuant to a request for Confidential Treatment.
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Royalty would be a calculated as a percentage of Net
Sales of the Sublicensee as determined in Section
3.1(a)(I) above. In addition, UNIVERSITY shall receive
*****/1/ of any non-royalty consideration received by
LICENSEE for sublicensing of technology licensed
hereunder.
The obligation to pay Royalties hereunder is imposed only once with
respect to the sale, lease or disposition of any Product or Combination Product
regardless of the number of Valid Claims which cover such Product or Combination
Product. Additionally, there shall be no obligation to pay Royalties on the
sale, lease or disposition of Products by LICENSEE or its Affiliates to any
Sublicensees for resale, but in such instances, the obligation to pay Royalties
shall arise upon the sale by any such Sublicensee to unrelated third parties.
(b) Milestone payments (which shall be paid only once per
Product) as follows:
(i) *****/1/ Dollars within sixty (60) days of the first
approved submission of an IND in any country of the
Territory on a Product,
(ii) *****/1/ Dollars within sixty (60) days of the start of
a Phase II clinical trial in any country of the
Territory,
(iii) *****/1/ within sixty (60) days of the first FDA
approval or its equivalent in any country of the
Territory on a Product.
3.2 Upon commencement of Net Sales of Products or Combination
Products which generate a Royalty to the UNIVERSITY pursuant to this Agreement,
LICENSEE shall, within sixty (60) days of the close of the calendar quarter in
which such Net Sales begin, make quarterly reports to the UNIVERSITY indicating
the total Net Sales of Products and Combination Products in the quarter and the
calculation of Royalties due thereon. Any Royalty then due and payable shall be
included with such report.
LICENSEE'S records shall be open to inspection by the UNIVERSITY or a
certified public accountant designated by the UNIVERSITY, at reasonable times,
and from time to time, for the sole purpose of verifying the accuracy of the
reports and the Royalty payments. The UNIVERSITY shall bear the reasonable
costs of such inspection unless the inspection establishes an error in the
UNIVERSITY'S favor of *****/1/ or more of the amount payable for the period of
inspection. The UNIVERSITY shall keep all reports, information, documents and
other materials received from LICENSEE under this Agreement, including the
reports made pursuant to the preceeding paragraph, confidential and the use of
such reports and information by the UNIVERSITY is strictly limited to the
enforcement of the UNIVERSITY'S rights under this Agreement.
4. PATENTS
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4.1 Prior Patent Expenses: Within five (5) business days following
the execution of this Agreement, LICENSEE shall reimburse the UNIVERSITY for all
unreimbursed out-of-pocket amounts expended by the UNIVERSITY, Emory University
and Oregon State University prior to the date hereof for the preparation,
filing, prosecution and maintenance of Licensed Patent Rights being licensed to
LICENSEE pursuant to Paragraph 2.1 of this
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1 Confidential information is omitted and identified by a * and filed
separately with the SEC pursuant to a request for Confidential Treatment.
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Agreement, said amount being $*****/1/. The UNIVERSITY will promptly reimburse
Emory University and Oregon State University for such amount that was expended
by Emory University and Oregon State University, and LICENSEE shall have no
responsibility for any amounts owed to such institutes for prior patent
expenses.
4.2 Future Patent Expenses: LICENSEE shall select qualified
independent patent counsel reasonably satisfactory to the UNIVERSITY to file,
prosecute and maintain all patent applications included in Licensed Patent
Rights, at the expense of LICENSEE, including divisionals, continuations,
continuations-in-part, reissues, renewals, foreign counterparts or extensions.
LICENSEE shall be entitled to determine the countries in which it wishes to
obtain and maintain patent protection under this Agreement and shall be free, at
any time and at its sole option and upon Notice to the UNIVERSITY, to abandon
patent prosecution or maintenance in any country of the Territory.
4.3 Should Licensee decide not to finance the preparation, filing,
prosecution, or maintenance of any patent application or patent licensed
hereunder, LICENSEE will give Notice to the UNIVERSITY of such decision in
writing in adequate time to allow the UNIVERSITY, 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 the
UNIVERSITY to file or maintain any U.S. or foreign patents at its own expense,
or to defend, enforce, or support any patent or patent applications which may be
included in Licensed Patents Rights to which it has granted license rights to
LICENSEE; provided, however, that the UNIVERSITY will cooperate with LICENSEE in
its activity in applying for U.S. or foreign patents or in the defense or
enforcement of Licensed Patent Rights.
Nothing herein is intended or shall be construed as obligating
LICENSEE 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 LICENSEE to do so.
4.4 LICENSEE, or any Affiliate or Sublicensee of LICENSEE, shall have
the right but not the obligation to institute patent infringement proceedings
against third parties based on any Licensed Patent Rights licensed hereunder.
The UNIVERSITY agrees to give Notice to LICENSEE promptly, in writing, of each
infringement of Licensed Patent Rights of which the UNIVERSITY is or becomes
aware during the term of this Agreement. If LICENSEE does not institute
infringement proceedings against such third parties, the UNIVERSITY shall have
the right, but not the obligation, to institute such proceedings within thirty
(30) days after Notice of its intention to commence such proceedings shall have
been given to LICENSEE, in writing, and provided that Licensee does not, within
such thirty (30) day period, institute its own proceedings. The expenses of
such proceedings, including lawyers' fees, shall be borne by the Party
instituting suit. The Party instituting suit shall have the right to select
counsel to conduct the suit. Each Party shall execute all necessary and proper
documents and take all other appropriate action, including but not limited to
being named as a participating party, to allow the other Party to institute and
prosecute such proceedings. Any award paid by third parties as a result of such
proceedings (whether by way of settlement or otherwise) shall first be applied
toward reimbursement for the legal fees and expenses incurred, and the excess,
if any, shall be shared on a pro rata basis based on the expenses incurred by
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each Party.
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1 Confidential information is omitted and identified by a * and filed
separately with the SEC pursuant to a request for Confidential Treatment.
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5. SPONSORED RESEARCH
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LICENSEE agrees to sponsor further research on the Core Technology by
XX. XXXXXXX X. XXXXXXXXX and his colleagues at the UNIVERSITY for a minimum
period of two (2) years at the budget level provided for in
Exhibit "B", attached hereto. Sponsorship at this level shall continue for a
third and subsequent years thereafter unless LICENSEE gives the University a
minimum of six (6) months' notice that it does not wish to fund research for
such third or subsequent years.
LICENSEE shall pay the budgeted amounts to the UNIVERSITY in advance
for a two (2) year period of guaranteed support, the total payment therefor, in
the amount of $*****/1/, being payable upon within five (5) business days
following the execution of this Agreement.
6. ACADEMIC FREEDOM
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The Parties recognize the traditional freedom of all scientists to
publish and present promptly the results of their research. The Parties also
recognize that patent rights can be jeopardized by public disclosure prior to
the filing of suitable patent applications. Therefore, the UNIVERSITY will
assure that each proposed publication concerning any technology described in
Licensed Patent Rights or Technical Information or which may constitute an
Invention or Improvement hereunder, before submission to a publisher, will be
submitted to LICENSEE for review in connection with preservation of patent
rights. LICENSEE shall have thirty (30) days in which to review the
publication, which may be extended for an additional thirty (30) days when
LICENSEE provides substantial and reasonable need for such extension. By mutual
agreement, this period may be further extended for not more than an additional
three (3) months. LICENSEE will allow for simultaneous submission of the
publication to the publisher and LICENSEE, where appropriate. Scientists acting
on behalf of both the UNIVERSITY and LICENSEE will be expected to treat matters
of authorship in a proper collaborative spirit, giving credit where it is due
and proceeding in a manner which fosters cooperation and communication.
7. Publicity
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LICENSEE will not use the UNIVERSITY'S name or the name of any member
of its faculty or its staff for any public, commercial or advertising purposes
without the prior written approval of the UNIVERSITY and faculty or staff
member involved; provided, however, that it is expressly agreed that LICENSEE
may reveal or identify the UNIVERSITY or any member of its faculty or staff as
the inventor, source or origin of any Core Technology, Technical Information or
any Product or Process for the purpose of soliciting third parties to invest or
enter into other commercial arrangements with LICENSEE, or to acquire a
Sublicense, assignment or other transfer of rights in such Core Technology from
LICENSEE and provided further that LICENSEE may use and disclose the
UNIVERSITY'S name and the name of any member of its faculty or its staff in its
internal communications or, upon prior disclosure and consultation with the
UNIVERSITY, in making any required governmental reports and filings.
It is recognized by the Parties that at some future date, a public
offering of securities may be contemplated by LICENSEE. The UNIVERSITY intends
to cooperate with LICENSEE in expeditiously reviewing any LICENSEE registration
statements and/or prospectuses, but wishes to reserve its rights with respect to
how its name will be used.
_____________
1 Confidential information is omitted and identified by a * and filed
separately with the SEC pursuant to a request for Confidential Treatment.
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8. PRODUCT LIABILITY
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LICENSEE agrees to indemnify and hold harmless the UNIVERSITY (and the
UNIVERSITY'S co-owners of the Licensed Patent Rights described on Exhibit "A-2"
if Licensee obtains license right from such co-owners) and its trustees,
officers, agents, faculty, employees, and students from any and all liability
arising from injury or damage to person or property resulting directly or
indirectly from LICENSEE'S use, manufacture, or sale of any product covered by
any Licensed Patent Rights or Technical Information. This obligation may be
delegated by the LICENSEE to assignees and/or Sublicensees of the LICENSEE'S
rights under this Agreement and may be satisfied by THE LICENSEE'S and/or its
Sublicensees or assignees obtaining and maintaining until the expiration of all
licenses granted hereunder, appropriate and available product liability
insurance for a conventional amount of coverage generally deemed appropriate in
the biotechnology or pharmaceutical industry, under which insurance the
UNIVERSITY is named as an additional insured.
The UNIVERSITY shall promptly give the LICENSEE Notice of any claim
asserted or threatened on the basis of which the Party giving such Notice
intends to seek indemnification from LICENSEE as herein provided.
9. TERMINATION
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9.1 The licenses herein granted shall continue for the full term of
any patents licensed hereunder as the same or the effectiveness thereof may be
extended by any governmental authority, rule or regulation applicable thereto;
it being understood, however, that the LICENSEE'S right to continue the practice
of then existing Technical Information shall continue as a fully paid, perpetual
license.
9.2 The LICENSEE shall have the right to terminate any license
granted herein at any time upon ninety (90) days' prior written notice to the
UNIVERSITY.
9.3 Either Party may terminate this Agreement in the event of a
material breach by the other Party, provided only that the breaching Party is
given Notice of the breach and a reasonable time, not to exceed thirty (30)
days, in which to cure such breach.
9.4 The UNIVERSITY agrees that in the event of the termination of
this Agreement and of any option and/or license granted hereunder it will
continue any applicable Sublicense on the terms and conditions of such
Sublicense in effect at the time of any such termination.
10. DISCLAIMER
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EXCEPT AS EXPRESSLY SET FORTH HEREIN AND WITH RESPECT TO THE OWNERSHIP
OF THE LICENSED PATENT RIGHTS, INVENTIONS, IMPROVEMENTS, AND TECHNICAL
INFORMATION, THE UNIVERSITY MAKES NO WARRANTIES, EXPRESS OR IMPLIED, IN RESPECT
OF THE CORE TECHNOLOGY, TECHNICAL INFORMATION, LICENSED PATENT RIGHT, PRODUCT OR
PROCESSES AND SPECIFICALLY DISCLAIMS ANY WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE.
11. NOTICES
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Any Notice required to be given pursuant to this Agreement shall be
made by personal delivery or, if by mail, then by registered or certified mail,
return receipt requested, with postage and fees prepaid, by one Party to the
other Party at the addresses noted below, or to such other address as such Party
may designate in writing from time to time to the other Party.
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In the case of the LICENSEE, Notice should be sent to:
SIGA Pharmaceuticals, Inc.
000 Xxxxx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000
In the case of THE ROCKEFELLER UNIVERSITY, Notice should be sent to:
The Rockefeller University
0000 Xxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Attention: Office of the General Counsel
12. REPRESENTATION AND WARRANTIES
-----------------------------
The UNIVERSITY hereby represents and warrants to the LICENSEE that
(i) the UNIVERSITY has the right to grant the license herein
provided under the terms and conditions set forth herein;
(ii) there are no encumbrances or restrictions not set forth
herein on its right to grant the licenses herein provided;
and
(iii) this Agreement does not conflict with or breach any other
agreement or understanding to which the UNIVERSITY is a
party.
LICENSEE hereby represents and warrants to the UNIVERSITY that
(i) LICENSEE is a corporation duly organized and validly
existing under the laws of the State of Delaware, and
(ii) LICENSEE will deliver to the UNIVERSITY, on an on-going
confidential basis, any reports or other materials provided
to its shareholders.
13. ASSIGNMENT
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No Party hereto may assign any of its rights or obligations under this
Agreement to any third party, without the express prior written consent of the
other Party to this Agreement, which consent will not be unreasonably withheld
or delayed; provided, however, that no consent shall be necessary in the event
of (i) the sale, merger, acquisition or other business combination, or sale of
substantially all the assets, of LICENSEE or (ii) the sale of all of LICENSEE'S
rights with respect to any Product line or lines.
14. GOVERNING LAW
-------------
This Agreement shall be governed by and construed in accordance
with the laws of the State of New York.
15. FURTHER ACTION
--------------
At any time and from time to time, each Party agrees, without further
consideration, to take such actions and to execute and deliver such documents as
may be reasonable necessary to effectuate the purposes of this Agreement.
16. WAIVER
------
Any Waiver by any Party of a breach of any provision of this Agreement
shall not operate as or be construed to be a waiver of any other
E-187
breach of this provision or of any breach of any other provision of this
Agreement. The failure of a Party to insist upon strict adherence to any term
of this Agreement on one or more occasions shall not be considered a waiver or
deprive that party of the right thereafter to insist upon strict adherence to
that term or any other term of this Agreement.
17. SEVERABILITY
------------
If any provision of this Agreement is invalid, illegal, or
unenforceable, the balance of this Agreement shall remain in effect, and if any
provision is inapplicable to any person or circumstance, it shall nevertheless
remain applicable to all other persons and circumstances.
18. COUNTERPARTS
------------
This Agreement may be executed in any number of counterparts, each of
which shall be deemed an original, but all of which together shall constitute
one and the same instrument.
19. FORCE MAJEURE
-------------
The Parties shall not be liable in any manner for failure or delay in
fulfillment of all or part of this Agreement, directly or indirectly caused by
acts of God, governmental order or restrictions, war, war-like condition,
revolution, riot, looting, strike, lockout, fire, flood or other similar or
dissimilar causes or circumstances beyond the non-performing Party's control.
The non-performing Party shall promptly notify the other Party of the cause or
circumstance and shall recommence its performance of its obligations as soon as
practicable after the cause or circumstance ceases.
20. ARBITRATION.
-----------
In the event of any dispute under this Agreement, such dispute shall
be submitted to arbitration in accordance with the terms of this Section. The
party who is alleging that a dispute exists shall send a notice of such dispute
to all other parties, which notice shall set forth in detail the dispute, the
parties involved and the position of such party with respect thereto. Within
ten (10) business days after the delivery of such a notice, counsel for the
parties shall mutually select as an arbitrator an attorney practicing in New
York, New York, who is experienced in commercial arbitration. If counsel for
the parties are unable to agree upon the selection of the arbitrator, an
arbitrator residing in or about New York, New York shall be selected by the New
York office of the American Arbitration Association. The arbitrator so selected
shall schedule a hearing in New York, New York 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, and no party shall be
entitled to discovery in such matter. 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 in any jurisdiction designated by the successful party. The parties
to this Agreement agree that this paragraph has been included to rapidly and
inexpensively resolve any disputes between them with respect to the matters
described above, and that this paragraph shall be grounds for dismissal of any
court action commenced by any party with respect to a dispute arising out of
such matters. For purposes of this Section, Licensors may participate in any
arbitration either jointly or severally, in their sole discretion.
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21. ENTIRE UNDERSTANDING
--------------------
This Agreement, together with the Exhibits hereto and the concurrently
executed Agreement constitute the entire agreement between the Parties with
respect to the subject matter hereof, supersedes all prior understanding and
agreement by the Parties with respect to the subject matter hereof and may be
modified only by written instrument duly executed by each Party.
22. HEADING
-------
The headings contained herein are for the purpose of convenience only
and are not intended to define or limit the contents of such sections.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be duly
executed as of the day and year first above written.
SIGA PHARMACEUTICALS, INC.
By: /s/ Xxxxxx Xxxxxx
-----------------
Its: President
THE ROCKEFELLER UNIVERSITY
By: /s/ Xxxxxxxxx X. Xxxx
-----------------------------
Its: Executive Vice President
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The undersigned, STATE OF OREGON, acting by and through the State Board of
Higher Education on behalf of OREGON STATE UNIVERSITY, to the extent that it may
have rights in Licensed Patent Rights as defined in the attached Agreement
between THE ROCKEFELLER UNIVERSITY and the LICENSEE therein named, hereby
consents and joins in the license grant to the LICENSEE and agrees to be bound
by the term of such license grant with respect to its interest in the Licensed
Patent Rights described in Exhibit "A-2" attached to said Agreement, subject
only to the agreement of THE ROCKEFELLER UNIVERSITY to pay to the undersigned
*****/1/ of the net monies received by THE ROCKEFELLER UNIVERSITY pursuant to
Paragraph 3 thereof.
January 8, 1996 /s/ Xxxxxx X. Xxxxxx
--------------- --------------------------
Date Vice Xxxxxxx for Research
& Int'l Programs
THE ROCKEFELLER UNIVERSITY will promptly reimburse OREGON STATE UNIVERSITY
its share of the patent expenses paid to THE ROCKEFELLER UNIVERSITY pursuant to
paragraph 4.1 hereof. Additionally, and in consideration of OREGON STATE
UNIVERSITY'S joining in the license grant as above provided, THE ROCKEFELLER
UNIVERSITY agrees to pay to OREGON STATE UNIVERSITY *****/1/ of the net monies
received by THE ROCKEFELLER UNIVERSITY pursuant to Paragraph 3 thereof.
THE ROCKEFELLER UNIVERSITY
By /s/ Xxxxxxxxx X. Xxxx
---------------------------
Executive Vice President
_____________
1 Confidential information is omitted and identified by a * and filed
separately with the SEC pursuant to a request for Confidential Treatment.
E-190
The undersigned, EMORY UNIVERSITY, to the extent that it may have rights in
the attached Agreement between THE ROCKEFELLER UNIVERSITY and the LICENSEE
therein named, hereby consents and joins in the license grant to the LICENSEE
and agrees to be bound by the terms of the license grant with respect to its
interest in the Licensed Patent Rights described in Exhibit "A-2" attached to
said Agreement subject only to the agreement of THE ROCKEFELLER UNIVERSITY to
pay to the undersigned *****/1/ of the net monies received by THE ROCKEFELLER
UNIVERSITY pursuant to Paragraph 3 thereof.
EMORY UNIVERSITY
By /s/ Xxxx X. Xxxxxx
------------------
January 31, 1996
----------------
Date
THE ROCKEFELLER UNIVERSITY will promptly reimburse EMORY UNIVERSITY its
share of the patent expenses paid to THE ROCKEFELLER UNIVERSITY pursuant to
Paragraph 4.1 hereof. Additionally, and in consideration of EMORY UNIVERSITY'S
joining in the license grant as above provided, THE ROCKEFELLER UNIVERSITY
agrees to pay to EMORY UNIVERSITY *****/1/ of the net monies received by THE
ROCKEFELLER UNIVERSITY pursuant to Paragraph 3 thereof.
THE ROCKEFELLER UNIVERSITY
By /s/ Xxxxxxxxx X. Xxxx
------------------------
Executive Vice President
_____________
1 Confidential information is omitted and identified by a * and filed
separately with the SEC pursuant to a request for Confidential Treatment.
E-191
EXHIBIT A-1
The Rockefeller University's Docket: 102
Title: "SYNTHETIC PEPTIDES FROM STREPTOCOCCAL M PROTEIN AND VACCINES PREPARED
------ ----------------------------------------------------------------------
THEREFROM"
----------
U.S. Patent No.:
Issue Date:
Serial No.: 08/369,295
Filing Date: January 6, 1995
Corresponding patent applications and patents in:
Australia
Canada
Japan
Europe: Austria
Belgium
Switzerland/Liechtenstein
Germany
France
Great Britain
Luxembourg
Netherlands
Sweden
E-192
The Rockefeller University's Docket: 129
Title: "RECOMBINANT POXVIRUS AND STREPTOCOCCAL M. PROTEIN VACCINE"
U.S. Patent No.:
Issue Date:
Serial No.: 08/205,348
Filing Date: March 3, 1994
Corresponding patent applications and patents in:
Australia
Canada
Japan
Europe: Austria
Belgium
Switzerland/Liechtenstein
Denmark
Germany
France
Great Britain
Italy
Luxembourg
Netherlands
Spain
Sweden
E-193
The Rockefeller University's Docket: 180 CIP
Title: "THE DELIVERY AND EXPRESSION OF A HYBRID SURFACE PROTEIN ON THE
SURFACE OF GRAM POSITIVE BACTERIA"
U.S. Patent No.:
Issue Date:
Serial No.: 08/302,756
Filing Date: Xxxxx 0, 0000
Xxxxxxx Filing: PCT Application No. PCT/US93/02355
The Rockefeller University's Docket: 180
U.S. Patent No.: "A POLYPEPTIDE OF A HYBRID SURFACE PROTEIN"
Issue Date:
Serial No.: 08/280,390
Filing Date: July 26, 1994
No Foreign Filing
E-194
The Rockefeller University's Docket: 234
Title: "MULTIFUNCTIONAL SURFACE PROTEIN OF STREPTOCOCCI
Serial No.: 08/217,008
Filing Date: Xxxxx 00, 0000
Xxxxxxx Filing: PCT Application No. PCT/US93/00082
The Rockefeller University's Docket: 266
Title: "SURFACE PROTEIN OF STAPHYLOCOCCUS AUREUS"
Serial No. 08/254,968
Filing Date: June 7, 1994
Foreign Filing: PCT Application No. PCT/US95/07100
The Rockefeller University's Docket: 267
Title: "REGULATION OF EXOPROTEIN IN STAPHYLOCOCCUS AUREUS"
Serial No.: 08/248,505
Filing Date: May 24, 1994
No Foreign Filing
The Rockefeller University's Docket: 299
Title: "ENZYME FOR CLEAVAGE OF THE ANCHOR REGION OF SURFACE
PROTEINS FROM THE SURFACE OF GRAM-POSITIVE BACTERIA"
Serial No.: 08/319,540
Filing Date: October 7, 1994
Foreign Filing: PCT Application pending
E-195
The Rockefeller University's Docket 264
Title: "GENE SERUM OPACITY FACTOR"
U.S. Patent No:
Serial No: 08/115,227
Filing Date: September 1, 1993
Foreign Filing: PCT/ US94/09926
The Rockefeller University's Docket: RU 326
Title: "A BACTERIAL PLASMIN BINDING PROTEIN AND METHODS OF USE THEREOF"
Serial Number: Not Assigned
Filing Date: September 17, 1996
E-196
EXHIBIT A-2
The Rockefeller University's Docket: 29
Title: "PRODUCTION OF STREPTOCOCCAL M PROTEIN IMMUNOGENS"
U.S. Patent No.: 4,784, 948
Issue Date: November 15, 1994
Serial No.: 821,716
Filing Date: June 18, 1984
Corresponding patent applications and patents in:
Australia
Canada
Japan
Europe: Austria
Belgium
Switzerland/Liechtenstein
Denmark
Germany
France
Great Britain
Luxembourg
Netherlands
Sweden
Divisional applications Nos. 08/200,914 filed February 22, 1994
E-197
EXHIBIT B
XXXXXXX X. XXXXXXXXX LABORATORY:
The following is a brief outline of some of the research that is in progress in
my lab and their future directions based on these outgoing studies.
CURRENT AND FUTURE PROJECTS:
1. STREPTOCOCCAL VACCINE: Having made a construction in which the
Streptococcus gordonii expresses the conserved region of the M protein on its
surface, we are performing safety studies to determine if cross-reactive
antibodies are generated to this region. So far we found that there are no
cross-reactive antibodies produced in serum and saliva of rabbits or mice
colonized with these recombinant organisms, while antigen-specific antibodies
are present in both compartments. We are now preparing purified protein of the
conserved region from our clone to immunize rabbits with adjuvant to determine
if cross-reactive antibodies are produced by this route.
FUTURE: Using our mouse challenge model, we will test our current construct for
protection against streptococcal colonization. In preliminary experiments with
a small number of animals we observed protection to the same levels as were seen
with the vaccinia virus vector system. We are planning similar experiments
using a larger number of animals.
2. COMMENSAL VECTOR: We are in the process of preparing a new construct for
the streptococcal vaccine (second generation). This construct consists of
multiple repeats of the C-repeat region to see if it increases immunogenicity.
We have completed part of the construct in collaboration with Xx. Xxxxx at OSU
and it will take a few more months to complete.
FUTURE: Once the construct is complete in Xx. Xxxxx'x laboratory, we will test
it in our lab using our streptococcal challenge assay in mice. We also plan to
prepare other constructs in S. Gordonii to validate our patent claims. These
will include enzymes as well as molecules that have had their anchors modified
for secretion. The former will be tested for enzyme activity and the later in
an animal model for tolerance. We have also (in collaboration with group in
France) created vectors for vaginal delivery of antigens. Lactobacillus and
lactococci have now been engineered to deliver foreign antigens to this site.
We will now expand this to develop the system for the delivery of vaginal-
specific antigens (GP120/160 and gonococcal antigens). In addition, we will
determine if more that one antigen may be delivered and expressed on the
gordonii surface. We will engineer regions on the chromosome of the gordonii to
express both the M protein and the SDH molecule.
3. STAPHYLOCOCCAL FIBRINOGEN BINDING PROTEIN: We are currently in the process
of purifying the fibrinogen binding protein from our E. coli clone.
FUTURE: Once purified and sufficient quantities have been obtained, we will
prepare monoclonal and polyclonal antibodies and perform blocking experiments
both in vitro and in vivo. Since this protein is important in staphylococcal
colonization of implanted medical devices and catheters, this information will
allow us to evaluate its potential as a staphylococcal vaccine.
4. NEW ANTIBIOTIC TARGET FOR GRAM-POSITIVE BACTERIA: Studies to find a new
antibiotic against a Gram-positive bacteria, based on our identification of a
new target, is poised and ready to begin. We have isolated the enzyme
responsible for this attachment and have developed a rapid assay to test for
inhibitors. The chance of success will depend on the number of compounds that
can be screened. Contractual arrangements will need to be made with
pharmaceutical or independent companies to supply the compounds to be screened.
E-198
FUTURE: We will purify the enzyme to determine its sequence in order to clone
its gene. This will enable us to perform computer docking experiments to
identify compounds by rational drug design. Our long-term goal is to further
identify the complete attachment mechanism for surface proteins in hopes to
uncover other targets.
5. SERUM OPACITY FACTOR: The serum opacity factor (SOF) is a group A
- - -
streptococcal protein that induces opacity of mammalian serum. Our studies have
shown that the molecule is a surface enzyme that has the specificity to cleave
apolipoprotein A1 (ApoA1) of HDL. We have cloned and sequenced the molecule and
have prepared ApoA1 knockout mice for our future studies.
FUTURE: Because SOF may be used as an diagnostic assay for HDL, studies to
localize its activity will help in the development of the assay. Purified SOF
will be used to cleave ApoA1 and the cleavage products examined by physical and
chemical techniques to determine the site of cleavage. We will try to establish
the biological importance of SOF in mice by injecting them with purified SOF and
examining its effects. Since serum from ApoA1 knockout mice does not become
opaque after treatment with SOF, these animals will serve as controls.
E-199
AMENDMENT
TO LICENSE AND RESEARCH SUPPORT AGREEMENT
BETWEEN THE COMPANY AND ROCKEFELLER UNIVERSITY
AMENDMENT
---------
THIS AMENDMENT is effective as of October 1, 1996 by and between SIGA
PHARMACEUTICALS, INC. ("SIGA") and THE ROCKEFELLER UNIVERSITY ("ROCKEFELLER").
WHEREAS, SIGA and ROCKEFELLER have entered into a License Agreement
(the "Agreement") dated February 1, 1996; and
WHEREAS, the Parties desire to further amend the Agreement to add a
technology relating to Bacterial Plasmin Binding Protein.
NOW THEREFORE, in consideration of the foregoing premises and other
good and valuable consideration, the Parties hereby agree as follows:
1. Exhibit A-1 to the Agreement shall be amended to add the
following patent application:
The Rockefeller University's Docket: RU-326
Title: "A Bacterial Plasmin Binding Protein and
Methods of Use Thereof"
Serial No.: Not Assigned
Filing Date: September 17, 1996
2. In all other aspects, the Agreement shall remain unchanged and in
full force and effect.
IN WITNESS WHEREOF, the Parties have executed this amendment to the
Agreement.
THE ROCKEFELLER UNIVERSITY SIGA PHARMACEUTICALS, INC.
By:/s/ Xxxxxxx X. Xxxxxxx By:/s/ Xxxxxx X. Xxxxxx
---------------------- --------------------
Name: Xxxxxxx X. Xxxxxxx, Name: Xxxxxx X. Xxxxxx,
Vice President & General Vice President & Chief
Counsel Financial Officer
Date: September 27, 1996 Date: October 15, 1996
E-200
