Exhibit 10(xx)
RESEARCH AND LICENSE AGREEMENT
This Research and License Agreement (this "Agreement"), made as of October
l, 2002 (the "Effective Date"), between SIGA Technologies Inc., a corporation
organized under the laws of Delaware and having a place of business at 0000 XX
Xxxxxxxx Xxx, Xxxxx 000, Xxxxxxxxx, Xxxxxx 00000 (herein referred to as "Siga")
and TransTech Pharma, Inc., a corporation organized under the laws of Delaware
and having a place of business at 0000 Xxxxxxxxxx Xxxx Xxxxxxx, Xxxxx 000, Xxxx
Xxxxx, Xxxxx Xxxxxxxx 00000 (herein referred to as "TransTech") (Siga and
TransTech are each a "Party" and, collectively, the "Parties").
Recitals:
TransTech has developed, owns or controls rights to certain drug discovery
technology and intellectual property relating to designing, synthesizing,
testing and optimizing clinical drug candidates and Compounds.
Siga has developed, owns or controls rights to certain drug discovery
technology and intellectual property relating to biological targets.
Siga and TransTech desire to collaborate on the discovery, identification,
optimization and development of Compounds for the treatment of human diseases.
NOW, THEREFORE, in consideration of the premises recited above and the
covenants and obligations set forth below, and intending to be legally bound,
the Parties agree as follows:
ARTICLE 1
DEFINITIONS
1.1 "Affiliate" means, with respect to any Party, any Person that
controls, is controlled by or is under common control with such Party. A Person
shall be regarded as in control of another entity if it owns or directly or
indirectly controls at least fifty (50%) of the voting stock or other ownership
interest of the other entity (or alternatively, with respect to foreign
entities, if it owns the maximum such ownership interest permitted by law), or
if it possesses, directly or indirectly, the power to direct or cause the
direction of the management and policies of the entity or the power to elect or
appoint at least fifty (50%) of the members of the governing body of the entity.
1.2 "Business Day" means any weekday that is not a federal holiday.
1.3 "Code" shall have the meaning set forth in Section 11.3.
1.4 "Compound" is to be understood in its broadest possible sense to
encompass all types of chemical, biological or biochemical structures and
substances composed of two or more elements. Merely to illustrate the breadth of
this definition and not by way of limitation, "Compound" includes each and every
type of structure or substance composed of two or more elements of biological or
pharmaceutical interest; small and large molecules, macromolecules
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and assemblies; saccharides, carbohydrates, lipids, peptides, polypeptides,
proteins, amino and nucleic acids, derivatives of any of the foregoing and
chemical and physical combinations thereof; cell compounds, products and by
products, including without limitation antibodies, hormones and enzymes; and
various other modulators of biological activity.
1.5 "Confidential Information" means all proprietary, non-public
information and materials disclosed by one Party to the other that have or could
have commercial value or other utility in a Party's business, the unauthorized
disclosure of which could be detrimental to the disclosing Party's interests,
and which a Party takes reasonable efforts to keep confidential, without
limitation, Inventions, trade secrets, Know-How, data and materials provided by
the Parties or otherwise developed under this Agreement, research, technical,
development, manufacturing, commercialization, financial, personnel and other
business information and plans, whether in oral, written, graphic or electronic
form.
1.6 "Confidentiality Exception" shall have the meaning set forth in
Section 8.1.
1.7 "Derived" means obtained, developed, created, synthesized, designed,
derived or resulting from, based upon or otherwise generated (whether directly
or indirectly, or in whole or in part).
1.8 "Disclosing Party" shall have the meaning set forth in Section 8.1.
1.9 "Effective Date" shall have the meaning set forth in the preamble.
1.10 "Intellectual Property" means all of the following or their legal
equivalent or counterpart in any jurisdiction throughout the world: (i)
Inventions, patents, patent applications, patent disclosures and Patent Rights;
(ii) trademarks, service marks, trade dress, trade names, corporate names, logos
and Internet domain names; (iii) copyrights and copyrightable works; (iv)
registrations and applications for registration for any of the foregoing; and
(v) trade secrets, Know-How and Confidential and proprietary Information.
1.11 "Invention" means any finding, discovery, development, addition,
improvement, modification, formulation or change, whether patentable or not,
that is conceived, reduced to practice, developed, made or controlled by either
Party or both Parties under this Agreement.
1.12 "Integrated Compound Libraries" means libraries of Compounds, but not
including TTProbes(TM), synthesized by TransTech in a lead identification
process using TransTech Technology.
1.13 "Know-How" means trade secrets, and other unpatented technical and/or
proprietary information, data, specifications, plans, drawings, designs,
blueprints, formulae, processes and other similar items and materials. For the
avoidance of doubt, Know-How does not include Patent Rights.
1.14 "Ownership Share" shall have the meaning set forth in Section 6.2.1.
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1.15 "Patent Rights" means the rights and interests in and to all issued
patents and pending patent applications in any country, including, without
limitation, all provisional applications, substitutions, continuations,
continuations-in-part, divisions, and renewals, all letters patent granted
thereon, and all patents-of-addition, reissues, reexaminations and extensions or
restorations by existing or future extension or restoration mechanisms.
1.16 "Person" means any individual, firm, corporation, partnership,
limited liability company, trust, unincorporated organization or other entity or
a government agency or political subdivision thereto, and shall include any
successor (by merger or otherwise) of such Person.
1.17 "Product" means a drug product having Regulatory Approval comprising
at least one Program Compound.
1.18 "Program" means the collaborative scientific activities undertaken by
the Parties during the Program Term.
1.19 "Program Compound" means any Compound developed during the Program
displaying (a) biological activity of lOOnM IC50 or greater at a Screening
Target and (b) significant in vivo efficacy in an appropriate disease model at
oral doses less than 10mg/kg; provided, however, that "Program Compounds" shall
not include any TTProbes(TM).
1.20 "Program Director" means a research executive appointed by each Party
to serve as such Party's principal coordinator and liaison for the
collaboration. The Program Director appointed by Siga is referred to as the
"Siga Program Director," and the Program Director appointed by TransTech is
referred to as the "TransTech Program Director."
1.21 "Program Intellectual Property" means all Intellectual Property
relating to Program Compounds. In no event, however, shall Program Intellectual
Property include either (a) TransTech Technology or (b) Siga Technology or (c)
TTProbes(TM) or (d) Compounds in Integrated Compound Libraries that are not
themselves Program Compounds.
1.22 "Program Term" means that period of the Program beginning upon the
date the first Statement of Work is executed by the Parties and expiring on the
termination of all Research Projects.
1.23 "Project Group" means a group (as further described in Section 2.3.2)
responsible for developing a particular Research Project plan, recommending
allocation of resources to the Steering Committee, developing timelines,
milestones and all day-to-day activities associated with the execution of such
Research Project plan.
1.24 "Publication" shall have the meaning set forth in Section 8.2.3.
1.25 "Receiving Party" shall have the meaning set forth in Section 8.1.
1.26 "Regulatory Approval" means the technical, medical and scientific
licenses, registrations, authorizations and approvals (including, without
limitation, approvals of Biologics License Applications, supplements and
amendments, pre- and post- approvals, pricing and third-
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party reimbursement approvals, and labeling approvals) of any national,
supra-national, regional, state or local regulatory agency, department, bureau,
commission, council or other governmental entity, necessary for the commercial
manufacture, distribution, marketing, promotion, offer for sale, use, import,
export and sale of any drug product with respect to any portion of the
Territory.
1.27 "Research Project" means all research activity related to a single
Screening Target, as detailed in an applicable Statement of Work.
1.28 "Screening Targets" means molecular targets selected for use by the
Parties in connection with Research Projects pursuant to Section 3.2.
1.29 "Siga Know-How" means, collectively, all Know-How (other than
TransTech Know-How) embodied in the Siga Technology.
1.30 "Siga Patent Rights" means, collectively, all Patent Rights (other
than TransTech Patent Rights) that embody, but only to the extent they embody,
Siga Technology.
1.31 "Siga Technology" means, collectively, (a) all Screening Targets
proprietary to Siga, including but not limited to the proprietary Screening
Targets set forth in Exhibit B, and all uses thereof; (b) all proprietary or
confidential materials and information of Siga that it delivers or discloses to
TransTech under the Program or in the course of a Research Project and all uses
thereof; (c) all uses of the Screening Targets that are Derived from the
activities under this Agreement; (d) all information and materials (other than
TransTech Technology) specifically regarding the foregoing (and all tangible and
intangible embodiments thereof) that is delivered or disclosed by Siga to
TransTech or is Derived from the activities under this Agreement and all uses
thereof; and (e) Inventions owned solely by Siga. All Siga Technology that does
not fall within the scope of a Confidentiality Exception shall be Confidential
Information of Siga.
1.32 "Statement of Work" means each statement in the form attached as
Exhibit A, and forming a part hereof, which shall be prepared and executed
jointly by the parties from time to time and each of which is specific to a
particular Research Project.
1.33 "Steering Committee" shall have the meaning set forth in Section
2.1.1.
1.34 "Territory" means worldwide.
1.35 "Third Party" means a Person other than Siga, TransTech and their
respective Affiliates.
1.36 "TransTech Know-How" means, collectively, all Know-How (other than
Siga Know-How and Program Intellectual Property) embodied in the TransTech
Technology.
1.37 "TransTech Patent Rights" means, collectively, all Patent Rights
(other than Siga Patent Rights and Program Intellectual Property) that embody,
and only to the extent they embody, the TransTech Technology.
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1.38 "TransTech Technology" means, collectively, (a) the TransTech
Technology Platform and all uses thereof, (b) TTPredict(TM) and all uses
thereof; (c) TTProbes(TM) and all uses thereof, (d) TTPScreen(TM) and all uses
thereof, (e) Inventions owned solely by TransTech; (f) all proprietary or
confidential materials and information of TransTech (other than materials or
information Derived under the Program or any Research Project) which are
required to be delivered or disclosed by TransTech to Siga under the Program or
any Research Project and all uses thereof, (g) all materials (other than the
Siga Technology and the Program Intellectual Property) Derived from any of the
foregoing and all uses thereof, and (h) all information (other than the Siga
Technology and the Program Intellectual Property) specifically regarding the
foregoing (and all tangible and intangible embodiments thereof) that is
disclosed by TransTech to Siga, or Derived from the activities under this
Agreement. All TransTech Technology that does not fall within the scope of a
Confidentiality Exception shall be Confidential Information of TransTech.
1.39 "TransTech Technology Platform" means TransTech's proprietary
information system consisting of advanced databases and search tools.
1.40 "TTPredict(TM)" means proprietary and customized tools for protein
structure determination, ligand binding site discovery, efficient in silico
screening, efficient compound ranking, scoring and enumeration of Compounds
against biological targets.
1.41 "TTProbes(TM)" means compound libraries consisting of Compounds
especially designed by TransTech for lead identification.
1.42 "TTPScreen(TM)" means proprietary and customized software and
hardware tools for the high throughput multi-well microplate pipetting,
screening, data capturing and analysis of Compounds against various biological
targets.
ARTICLE 2
MANAGEMENT OF RESEARCH PROJECTS AND THE PROGRAM
2.1 Steering Committee.
2.1.1 Composition. The Parties shall establish a joint management
committee (the "Steering Committee"), comprised of three (3) representatives of
Siga (including the Siga Program Director) and three (3) representatives of
TransTech (including the TransTech Program Director). Each Party shall make its
initial designation of its representatives as soon as practicable and may
replace its representatives at any time upon prior notice to the other Party.
Each Party shall use reasonable efforts to cause its representatives to attend
the meetings of the Steering Committee. If a representative of a Party is unable
to attend a meeting, such Party may designate an alternate to attend such
meeting in place of the absent representative. In addition, each Party may, at
its discretion, invite non-voting employees, and, with the consent of the other
Party, in its discretion, outside consultants or scientific advisors, to attend
the meetings of the Steering Committee in order to, among other things, review
and discuss the Program and the Research Projects.
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2.1.2 Responsibilities. The Steering Committee shall oversee and
supervise the overall performance of the Program and shall:
(a) review and approve the efforts of the Parties in the conduct of
the Program and the Research Projects;
(b) review and approve amendments to each Statement of Work;
(c) reallocate resources within a Research Project;
(d) establish the Project Groups for each Research Project;
(e) address such other matters as either Party may bring before the
Steering Committee;
(1) attempt to resolve any dispute relating to this Agreement that
may arise between the Parties; and
(g) oversee reasonable and customary efforts to conduct intellectual
property clearances required for the Program Compounds and evaluate the
proprietary or novel nature of any Program Compound.
2.1.3 Frequency of Meetings. The Steering Committee shall meet
within forty-five (45) days after the Effective Date and, thereafter, at least
semi-annually during the course of the Program Term. Either Party may convene a
special meeting of the Steering Committee on fifteen (15) days written notice to
the other Party, which notice may be waived by the other Party.
2.1.4 Place of Meetings and Agenda. The location of such meetings of
the Steering Committee shall alternate between Siga's principal place of
business and TransTech's principal place of business, or as otherwise agreed by
the Parties. Meetings may be held by telephonic, video or Internet conferencing,
so long as all participants can speak to, be heard by and hear all other
participants. In consultation with the other Party's Program Director, the host
of such meetings shall prepare an agenda and deliver the same to the other Party
no later than five (5) Business Days before each meeting of the Steering
Committee.
2.2 Decision Making. A meeting of the Steering Committee shall have
achieved a quorum only if two representatives of the Steering Committee from
each Party are present at such meeting. Any decision made by the Steering
Committee without a quorum shall be null and void, unless subsequently ratified
by a quorum of the Steering Committee. Each Party shall have one vote on the
Steering Committee. Both Parties must vote in the affirmative to allow the
Steering Committee to take any action that requires the vote of the Steering
Committee. If a Project Group is unable to reach unanimous agreement on any
matter, such matter shall be referred to the Steering Committee. If the Steering
Committee is unable to reach unanimous agreement, the disputed issue will be
referred to a senior management representative from each Party, who shall
promptly meet and endeavor in good faith to resolve such matter in a timely
manner and should these representatives not resolve said issue within seven (7)
Business Days of such referral, the issue will be decided by TransTech.
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2.3 Management of Collaboration.
2.3.1 Program Directors. Siga and TransTech shall each appoint a
Program Director prior to the Effective Date. During the Program Term, each
Party shall have the right, after consultation with the other Party, to
designate a different Program Director. The Program Directors shall jointly
oversee the conduct of the Program, shall report to the Steering Committee and
shall be responsible for recommending to the Steering Committee any change to
the Program or to any Research Project, after consultation with the appropriate
Project Group.
2.3.2 Project Groups. A separate Project Group shall be established
by the Steering Committee to administer under its direction each specific
Research Project. Each Project Group shall be comprised of representatives of
each Party. Each Project Group shall have one leader from each Party, who shall
be responsible for coordination with each other and with the Program Directors.
The members of each Project Group shall communicate on a regular basis and, at
least quarterly, shall meet to review the progress of the Research Project for
which such Project Group is responsible and to make appropriate recommendations
to the Steering Committee related to such Research Project. Each Project Group
will develop a communication plan, subject to review by and approval of the
Steering Committee, which shall outline a regular Project Group meeting
schedule, a timeline for distribution of minutes of Project Group meetings,
e-mail interactions, video conference schedules, frequency of reports, and a
distribution list.
2.3.3 Dispute Resolution of the Program Directors. The Program
Directors shall decide matters appropriate to the scope of their
responsibilities on a consensus basis. In the event that the Program Directors
are unable to reach agreement on any matter within fifteen (15) days after the
matter is first considered by them, either Program Director may refer the issue
to the Steering Committee for resolution in accordance with Section 2.2.
2.4 Minutes. The host of each meeting, either Steering Committee or
Project Group, shall prepare minutes of each such meeting, including attaching
copies of all data and reports presented at the meeting, and shall provide such
minutes to the other for approval within fifteen (15) Business Days after such
meeting or as soon thereafter as may be practicable. The other Party shall have
ten (10) Business Days from receipt of the draft minutes to either propose
revisions or provide a good faith estimate of the earliest practicable date when
any proposed revisions shall be available. If neither is received in ten (10)
Business Days, then the drafter may presume that the minutes are considered
final. The Program Directors shall sign all final minutes.
ARTICLE 3
SELECTION OF SCREENING TARGETS; STATEMENTS OF WORK
3.1 Collaboration. The purpose of this Agreement is for TransTech and Siga
to collaborate in performing at least one (1) Research Project in screening for
and discovering Program Compounds that modulate Screening Targets. Research
Projects shall be set forth in a Statement of Work, as outlined herein.
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3.2 Selection of Screening Targets. For each Research Project, the Parties
shall select a Screening Target from the targets described in Exhibit B.
3.3 Statements of Work. Before initiation of any work on a Research
Project, a Statement of Work will be jointly prepared and executed by the
Parties. Each Statement of Work will be governed by all of the provisions and
rights and obligations of each Party as set forth in this Agreement. Each
Statement of Work shall (a) identify the specifics of any Research Project, (b)
describe all major responsibilities and activities of each of the Parties and
the field of potential applications to be covered during the Research Project,
and (c) be more fully described in the form of Exhibit A. The Parties hereby
agree to implement the first Statement of Work within sixty (60) days after the
Effective Date. In the event of a conflict between the terms and conditions of
this Agreement and a Statement of Work, the terms and conditions of this
Agreement shall prevail.
3.4 Equipment, Facilities and Personnel. Each Party shall provide the
necessary personnel, facilities, equipment and supplies required to perform its
activities set forth in this Agreement and in each Statement of Work. Each Party
warrants and represents that it will exercise reasonable efforts to have the
facilities, professional, technical and clerical staff, experience and expertise
in sufficient quality and quantity to perform such Party's activities set forth
in this Agreement and in each Statement of Work in a timely and professional
manner.
3.5 Non-compete. It is understood and agreed that neither Party shall,
alone or in collaboration with a Third Party, pursue research programs during
the Program Term that would compete directly with the collaborative activities
set forth in this Agreement or in any Statement of Work.
ARTICLE 4
RESPONSIBILITIES
4.1 TransTech Responsibilities. TransTech will contribute services for
each Research Project in accordance with the specific tasks contained in the
applicable Statement of Work, including, but not limited to, the following:
4.1.1 Screen such of TransTech's existing Compound libraries
(including, where appropriate, TTProbes(TM) and Integrated Compound Libraries)
as may be available for lead Compounds, including through the use of high
throughput screening;
4.1.2 Design, synthesize and screen new Compound libraries,
including Integrated Compound Libraries directed towards Screening Targets,
based on Compounds and chemical scaffolds from TransTech, including through the
use of high throughput screening;
4.1.3 Optimize lead Compounds towards criteria for Program
Compounds; and
4.1.4 Identify organizations to contact with respect to the further
optimization of potential drug candidates, the conduct of pre-clinical and
clinical studies, the obtaining of Regulatory Approval and the manufacturing,
distribution and marketing of Products.
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4.2 Siga Responsibilities. Siga will contribute services for each Research
Project in accordance with the specific tasks contained in the applicable
Statement of Work, including, but not limited to, the following:
4.2.1 Take appropriate steps to insure the availability of selected
Screening Targets and related primary assays;
4.2.2 Conduct secondary bacterial inhibition screens; and
4.2.3 Provide appropriate in vitro or in vivo efficacy studies,
except to the extent such work may be outsourced as provided in Section 7.1.
4.3 Special Reports. Each Party shall promptly report to the other Party
any significant or material development, problem or issue as it arises.
4.4 High Standards; Compliance with Laws. Each Party will use
scientifically reasonable efforts to ensure that all information provided by one
Party to the other Party pursuant to this Agreement is accurate in accordance
with scientifically accepted standards. Each Party shall also comply with all
current governmental regulatory requirements as appropriate to the activities
set forth in this Agreement and in each applicable Statement of Work and all
other applicable national, federal, state and local laws and regulations.
4.5 Inspections. Upon not less than ten (10) Business Days prior written
notice, each Party shall have the right to have its Program Director and no more
than two other representatives inspect, at the investigating Parties sole
expense, no more than once per calendar year, the facilities and records
relating to any Research Project of the other Party and any Third Party
conducting any portion of the activities set forth in this Agreement or pursuant
to any Statement of Work on behalf of a Party, and to discuss the screening of
the Screening Targets and development of the Program Compounds with the
appropriate technical and business personnel and consultants of the other Party,
provided that such inspections shall be during normal business hours and shall
not unreasonably interrupt the operations of such Party or Third Party(ies)
acting on behalf of such Party.
ARTICLE 5
RECORD KEEPING
5.1 Laboratory Notebooks. All work conducted by or on behalf of either
Party in the course of performing the Program shall be completely and accurately
recorded, in sufficient detail and in good scientific manner, in laboratory
notebooks kept separately from the other research and development activities of
such Party or Third Party(ies) acting on behalf of such Party.
5.2 Policies for Maintaining Records; Assignments of Inventions. In order
to protect applicable Patent Rights in any invention conceived or reduced to
practice during or as a result of the Program and in the Program Intellectual
Property and the Program Compounds, the Parties shall require their employees or
Third Party(ies) acting on their behalves to record and maintain all data and
information developed for the Research Projects hereunder during the Program in
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such a manner as to enable the Party holding such Patent Rights to use such
records to establish the earliest date of invention and/or diligence to
reduction to practice. At a minimum, the policy shall require such individuals
to record all Inventions generated by them in standard laboratory notebooks,
which are dated and corroborated by non-inventors on a regular, contemporaneous
basis. The policy shall also require all employees or Third Party(ies) engaged
in the Program to assign all Intellectual Property conceived or reduced to
practice in connection therewith to the appropriate Party, and each Party shall
ensure that each such employee or Third Party(ies) acting on its behalf has
signed such an agreement before the applicable Statement of Work is begun.
ARTICLE 6
LICENSES AND INTELLECTUAL PROPERTY RIGHTS
6.1 License Grant by Siga. Subject to the terms and conditions of this
Agreement, during the Program Term, Siga hereby grants to TransTech (a) a
exclusive, fully-paid, nontransferable, nonsublicenseable, limited license to
use the Siga Patent Rights, Siga Know-How, and Siga Technology to perform the
obligations and responsibilities allocated to TransTech under the Research
Projects, (b) to the extent the Parties claim in any patent application directed
to the Program Compounds a genus that claims Compounds in addition to the
Program Compounds, an exclusive, fully-paid license to use such Compounds other
than Program Compounds for any purpose and (c) after the expiry of the Program
Term, if active development of a Program Compound has ceased, an exclusive,
fully-paid license to use such Program Compounds for any purpose. Except as
expressly provided above, TransTech shall not use the Siga Patent Rights, Siga
Know-How or Siga Technology for any other purpose and Siga reserves all rights
in the Siga Patent Rights, Siga Know-How and Siga Technology and no license is
granted to TransTech, expressly or by implication, to any other Siga
Intellectual Property by virtue of this Agreement.
6.2 Program Intellectual Property and Program Compounds.
6.2.1 Ownership. If a Program Compound relates to a Screening Target
that is Siga Technology, each Party shall have an undivided one-half (1/2)
interest in such Program Compound and all related Program Intellectual Property,
regardless of whether such is invented, discovered or developed by one or both
Parties. If a Program Compound does not so relate, then Siga shall have an
undivided 25% interest and TransTech shall have an undivided 75% interest. The
applicable ownership ratio shall be known in this Agreement as the "Ownership
Share". The Parties will execute all documents necessary to effectuate such
ownership.
6.2.2 Product Registrations. Except as provided in ARTICLE 7, the
Parties shall jointly obtain and maintain, and share according to the Ownership
Share in the cost and expense for, all permits, licenses, authorizations and
registrations for any country and for any local sovereignty, state, county,
parish, municipality, or other local governmental entity that are necessary for
the development, import, export, manufacture, distribution and/or sale of
Products.
6.3 Prosecution and Maintenance of Patent Rights.
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6.3.1 Management of Prosecution and Maintenance. Siga shall have an
outside law firm mutually acceptable to both Parties prepare, file, prosecute
and maintain Patent Rights claiming Inventions that are part of Program
Intellectual Property. The Steering Committee shall determine which
jurisdictions to file and maintain Patent Rights in. If Siga fails to have a
mutually acceptable outside law firm prepare, file, prosecute or maintain Patent
Rights covering any such Invention(s) after notice from TransTech with time to
cure, then TransTech shall have the right to assume responsibility for the
preparation, filing, prosecution, and maintenance of Patent Rights in any such
Invention(s). All costs incurred by the Parties in carrying out patent
preparation, filing, prosecution and maintenance of Patent Rights for such
Inventions shall be borne by the Parties according to the Ownership Share.
6.3.2 Cooperation. Each Party shall cooperate with the other with
respect to the preparation, filing, prosecution, maintenance and extension
recordation of Patent Rights pursuant to this Section 6.3, including, without
limitation, the execution of all such documents and instruments and the
performance of such acts as may be reasonably necessary in order to permit the
other Party to continue any preparation, filing, prosecution, maintenance or
extension recordation of Patent Rights that such Party has elected not to
pursue, as provided for in Section 6.4.
6.3.3 Siga Patent Rights. Siga shall be solely responsible for the
prosecution, maintenance and enforcement of Siga Patent Rights in all countries.
All costs associated with these activities shall be borne by Siga.
6.3.4 TransTech Patent Rights. TransTech shall be solely responsible
for the prosecution, maintenance and enforcement of TransTech Patent Rights in
all countries. All costs associated with these activities shall be borne by
TransTech.
6.4 Third-Party Infringement.
6.4.1 Reasonable Action. Except as provided in Section 6.4.2 with
respect to commencing infringement litigation, TransTech and Siga shall take
commercially reasonable actions to protect the Patent Rights relating to Program
Intellectual Property from infringement and to protect such Patent Rights from
unauthorized use, when, from its own knowledge or upon notice from the other
Party, the Party with knowledge or receiving notice becomes aware of the
reasonable probability that such infringement or unauthorized use exists. In
addition, each Party shall promptly apprise the other Party of any suspected or
actual infringement of any other proprietary right with respect to the Products
or Program Compounds, or any unfair or unlawful competitive practices being
practiced by a Third Party in connection with the Products or Program Compound
of which it becomes aware.
6.4.2 Infringement Actions. Each Party shall have the right (but not
the obligation) to petition the Steering Committee to authorize the Parties to
institute a suit or other appropriate action upon becoming aware of any
infringement of the Program Compounds or Program Intellectual Property.
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6.4.3 Costs. The Parties shall share according to the Ownership
Share in the payment of all out-of-pocket costs incurred in connection with any
action, litigation or proceeding described in this Section 6.4, including,
without limitation, the fees and expenses of counsel and experts. Each Party
shall bear its internal costs, regardless of the relative contributions of the
Parties.
6.4.4 Recoveries. Any recovery obtained by any Party as a result of
any proceeding described in this Section 6.4 shall be applied in the following
order of priority:
(a) first, to reimburse each Party for all litigation costs in
connection with such proceeding paid by that Party and not otherwise recovered
(on a pro rata basis based on each Party's respective litigation costs, to the
extent the recovery was less than all such litigation costs), including without
limitation documented internal costs; and
(b) second, the remainder of the recovery shall be shared
according to the Ownership Share.
6.4.5 Cooperation; Settlements. In the event that either Siga or
TransTech takes action pursuant to Section 6.4.2, the other Party shall
cooperate with the Party so acting to the extent reasonably possible, including
the joining of suit if desirable. Neither Party shall settle or compromise any
claim or proceeding relating to Patent Rights for Program Intellectual Property
without obtaining the prior written consent of the other Party, such consent not
to be unreasonably withheld or delayed.
6.5 Patent Term Extensions. The Parties shall cooperate, if necessary and
appropriate, in gaining patent term extensions wherever applicable to Patent
Rights covering Products. The Parties shall share equally in all costs connected
with all filings for such extensions.
6.6 No Additional Obligation. Nothing in this Agreement shall create any
obligation on the part of either Party to obtain Patent Rights, to enforce any
Intellectual Property against infringement by Third Parties or bear any expense
of the other Party with respect to Intellectual Property that is not Program
Intellectual Property.
ARTICLE 7
OUTSOURCING AND THIRD-PARTY LICENSING
7.1 Outsourcing. The Parties shall coordinate the procurement of
outsourced drug candidate optimization, pre-clinical and clinical testing,
regulatory approval, manufacturing, distribution and marketing services with
respect to Program Compounds and Products, working with the candidates
identified by TransTech pursuant to Section 4.1.4. Siga shall provide all data
and information necessary for a potential outsourcing provider to evaluate a
request to provide such services, and shall cooperate with any selected
provider. To the extent that any out-of-pocket payment shall be necessary to
obtain such outsourced services, the Parties shall bear such costs equally. Any
disagreement concerning the use of such outsourced services, or whether to
proceed with any such service, shall be resolved using the procedures set forth
in Section 2.2.
Page 12 of 23
7.2 Third-Party Licensing. The Parties may obtain any or all of the
outsourced services set forth in Section 7.1 through a license of Program
Intellectual Property to a Third Party. The Parties shall negotiate and execute
a license on behalf of the Parties with any appropriate Third Party ready,
willing and able to provide any such service. Any and all revenue derived from
any such license, including without limitation technology access fees, milestone
payments and royalties on sales, shall be shared by the Parties according to the
Ownership Share. Notwithstanding any other provision of this Agreement, the
Parties may share all or any portion of this Agreement with any licensee or
potential licensee that shall sign a confidentiality agreement in form and
substance reasonably acceptable to the other Party.
7.3 Option to Develop. In the event that either Siga or TransTech, but not
both, decide to continue development of Program Intellectual Property, any
Program Compound or any Product, and the result of invoking the procedures of
Section 2.2 is that such development need not continue, the parties will enter
into good-faith negotiations with respect to an agreement defining the terms and
conditions under which the continuing Party may pursue unilateral development,
taking into account the relative contributions of the parties through the date
of cessation of joint development and the costs likely to be incurred in future
development If the Parties are unable to reach agreement within sixty (60) days
of the commencement of such negotiations, then this Agreement will terminate
within the meaning of ARTICLE 11. After any such termination, and
notwithstanding any contrary provision of ARTICLE 11, Siga shall retain all
rights with respect to its proprietary biological targets, and TransTech shall
retain all rights with respect to any Program Compound or Product developed
during the term of this Agreement.
ARTICLE 8
CONFIDENTIAL INFORMATION
8.1 Confidentiality Obligations. Subject to Sections 8.3, 8.4 and 12.11,
for the term of this Agreement and for five (5) years thereafter, either Party
that receives Confidential Information (a "Receiving Party") from the other
Party (a "Disclosing Party") shall keep completely confidential and shall not
publish or otherwise disclose and shall not use for any purpose (except as
expressly permitted hereunder) any Confidential Information furnished to it by
the Disclosing Party pursuant to this Agreement, except to the extent that it
can be established by the Receiving Party that such Confidential Information:
(a) was already known to the Receiving Party, other than under an obligation of
confidentiality from the Disclosing Party; (b) was generally available to the
public or otherwise part of the public domain at the time of its disclosure to
the Receiving Party; (c) became generally available to the public or otherwise
part of the public domain after its disclosure and other than through any act or
omission of the Receiving Party in breach of this Agreement; (d) was
subsequently lawfully disclosed to the Receiving Party by a Third Party; (e) can
be shown by written records to have been independently developed by the
Receiving Party without reference to the Confidential Information received from
the Disclosing Party and without breach of any of the provisions of this
Agreement; or (f) is information that the Disclosing Party has specifically
agreed in writing that the Receiving Party may disclose (each of (a)-(f), a
"Confidentiality Exception"). The obligations of confidentiality and non-use set
forth in this Section 8.1 shall also apply to biological material, chemical
compounds and associated information thereto (including without
Page 13 of 23
limitation Know-How) disclosed by one Party to the other prior to or during the
term of this Agreement.
8.2 Further Obligations.
8.2.1 Each Party shall inform its employees and consultants who
receive Confidential Information of the other Party of the obligations of
confidentiality specified in Section 8.1 and all such Persons shall be bound by
the terms of confidentiality set forth therein.
8.2.2 The existence and the terms and conditions of this Agreement,
to the extent that the Parties have not specifically agreed to disclose them
pursuant to Section 8.3, shall be treated by each Party as Confidential
Information of the other Party.
8.2.3 Permitted Disclosures. The Receiving Party may disclose
Confidential Information in summary form to those directors, officers, managers,
agents, consultants and employees of the Receiving Party that have a
demonstrable need to know the Confidential Information for purposes of this
Agreement. Notwithstanding anything to the contrary herein, either Party may,
upon the advice of its counsel and without the prior consent of the other Party,
disclose or publish Confidential Information, the name or the trademarks of the
other Party or information concerning the Agreement as required by law,
governmental regulation, court order or alternative dispute resolution process;
provided, however, that in such case the Receiving Party shall as soon as
practicable give notice to the Disclosing Party so that the Disclosing Party may
seek a protective order or other remedy from an appropriate court or tribunal.
In any event, the Receiving Party shall disclose only that portion of the
Confidential Information that, in the opinion of its legal counsel, is legally
required to be disclosed and will exercise reasonable efforts to ensure that any
such information so disclosed will be accorded confidential treatment by said
court or tribunal.
8.3 Publication. In no event shall either Party publish any Confidential
Information of the other Party, except for publications and presentations (each,
a "Publication") for the advancement of science disseminated in accordance with
this Section 8.3. With respect to testing and screening activities conducted by
the Parties pursuant to this Agreement and any activities performed pursuant to
a Statement of Work, the Parties may publish or present their results and
activities for the advancement of science; provided, however, that prior to
making any Publication relating to the results of such activities, the
publishing Party shall provide to the other Party a copy of any proposed written
Publication or a detailed written description of any proposed oral Publication
at least sixty (60) days prior to submission or publication thereof. Neither
Party shall submit a Publication without the prior written consent of the other
Party, which consent shall not be unreasonably withheld or delayed. It is the
publishing Party's obligation to identify and remove, and the other Party's
right to identify and have removed, Confidential Information or other
information contained in a Publication prior to its submission to any outside
entity other than Confidential Information that is the subject of a published
Patent application. At least thirty (30) days prior to the publishing Party's
planned date to submit an article to any outside entity for review, the other
Party may identify any information in such Publication it considers as
Confidential Information. Such information shall be removed from the proposed
Publication prior to its submission to any such outside entity. The
non-publishing
Page 14 of 23
Party may, in its sole discretion, delay the disclosure of any Publication until
a Patent application, on any Invention disclosed in such Publication, is filed
and published. If the non-publishing Party fails to object to such Publication
within such thirty (30) day pre-submission time period, the non-publishing Party
shall be deemed to have consented to such Publication.
ARTICLE 9
REPRESENTATIONS, WARRANTIES AND COVENANTS
9.1 Authority. Each Party represents and warrants that as of the Effective
Date it has the full right, power and authority to enter into this Agreement and
grant the licenses hereunder, and that this Agreement has been duly executed by
such Party and constitutes a legal, valid and binding obligation of such Party,
enforceable in accordance with its terms.
9.2 No Conflicts. Each Party represents and warrants that the execution,
delivery and performance of this Agreement do not conflict with, or constitute a
breach or default under any of its charter or organizational documents, any law,
order, judgment or governmental rule or regulation applicable to it, or any
material agreement, contract, commitment or instrument to which it is a party.
9.3 Commercially Reasonable Efforts. Each Party represents and warrants
that it will use good faith, commercially reasonable and diligent efforts to
further, consistent with this Agreement and with sound business judgment, the
development of Products and to perform the activities for which it is
responsible under the Program.
9.4 Intellectual Property. Each Party represents and warrants to the other
that, as of the Effective Date:
9.4.1 It has no actual knowledge of any claim made against it
asserting the invalidity, misuse, non-registerability, non-enforceability or
non-infringement of any of its Intellectual Property that is a subject of this
Agreement or challenging its right to use or ownership of any of such
Intellectual Property or making any adverse claim of ownership thereof;
9.4.2 It has no actual knowledge of any pending or threatened claim
or litigation alleging that its activities to date relating to the Intellectual
Property that is the subject of this Agreement have violated, or by conducting
its business as currently proposed to be conducted hereunder would violate, the
Intellectual Property rights of any Third Party; and
9.4.3 Each of the Party's respective employees, agents, consultants,
Affiliates, subcontractors and sublicensees who are involved with the Program is
or will be subject to confidentiality obligations and has executed agreements or
will execute agreements assigning all inventions and developments related to any
of the foregoing to either Siga or TransTech.
9.4.4 Its work has not been part of a governmental funding
relationship that would result in any Intellectual Property right with respect
to any Program Compound or the Program Intellectual Property residing in the
National Institutes of Health or other agency or the U.S. or other governmental
authority, and that the licenses it grants under this Agreement are not
Page 15 of 23
subject to overriding obligations to the US. government as set forth in 35
U.S.C. ss. 200-212 of the United States Code, as amended, or any similar
obligation of any governmental authority or under the laws of any other country.
9.4.5 Except as otherwise provided herein, during the term of this
Agreement it will not grant rights to any Third Party with respect to the
research, development, use, manufacture, marketing, sale or distribution of
Program Compounds or Products in the Territory.
9.5 Disclaimer of Warranties. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH
HEREIN, THE PARTIES MAKE NO REPRESENTATION AND EXTEND NO WARRANTY OF ANY KIND,
EITHER EXPRESS OR IMPLIED, AND PARTICULARLY NO REPRESENTATION OR WARRANTY THAT
PRODUCTS WILL BE SUCCESSFULLY DEVELOPED HEREUNDER, AND IF DEVELOPED, WILL HAVE
COMMERCIAL UTILITY OR MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
ARTICLE 10
INDEMNIFICATION
10.1 Indemnification. Each Party shall indemnify, defend and hold harmless
the other Party, its Affiliates and their agents, employees, officers and
directors and successors and assignors from and against any and all liability,
damage, loss, cost or expense (including reasonable attorneys' fees) arising out
of any Third Party claim arising out of or related to a material breach by the
indemnifying party or any allegation that Siga Technology or TransTech
Technology infringes any Third Party intellectual property rights or negligence
or intentional misconduct of employees, contractors and consultants its
sublicensees or subcontractors of any of its covenants, representations or
warranties set forth in this Agreement or in any confidentiality agreement. The
recipient of any claim desiring to invoke this Section 10.1 shall promptly
notify its indemnitor of the existence and circumstances of any such claim,
shall cooperate in the defense of any such claim and shall not settle any such
claim without the consent of the indemnitor (such consent not to be unreasonably
withheld or delayed) without waiving its indemnity. The Steering Committee shall
be responsible for control of any defense action.
10.2 No Consequential Damages. NEITHER PARTY WILL BE LIABLE FOR SPECIAL,
INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT OR THE
EXERCISE OF ITS RIGHTS HEREUNDER, INCLUDING WITHOUT LIMITATION, LOST PROFITS
ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY
NOTICE OF SUCH DAMAGES; PROVIDED, HOWEVER, THAT NOTHING ACTUALLY PAID TO A THIRD
PARTY IN SETTLEMENT OR SATISFACTION OF ANY CLAIM SHALL BE DEEMED SUBJECT TO THIS
SECTION 10.2.
10.3 Insurance Proceeds. Any indemnification hereunder shall be made net
of any insurance proceeds recovered by the indemnified Party; provided, however,
that if, following the payment to the indemnified Party of any amount under this
ARTICLE 10, such indemnified Party recovers any insurance proceeds in respect of
the claim for which such indemnification payment was made, the indemnified Party
shall promptly pay an amount equal to the amount of
Page 16 of 23
such proceeds (but not exceeding the amount of such indemnification payment),
less the costs of collection, to the indemnifying Party.
ARTICLE 11
TERM AND TERMINATION
11.1 Term. This Agreement shall commence upon the Effective Date and,
unless extended by mutual written agreement of the Parties or terminated earlier
by such agreement or as provided hereunder, shall expire upon the agreed
cessation of development of all Program Compounds and the cessation of sales of
all Products.
11.2 Breach. The failure by either Party to comply with any of the
material obligations contained in this Agreement shall entitle the non-breaching
Party to give written notice to have the default cured. If such default is not
cured within sixty (60) days after the receipt of such written notice, or
diligent steps are not taken to cure if by its nature such default could not be
cured within sixty (60) days, the notifying Party shall be entitled, without
prejudice to any of its other rights conferred on it by this Agreement, and in
addition to any other remedy that may be available to it by law, pursuant to
this Agreement or otherwise, to terminate this Agreement; provided, however,
that in the case of a failure to pay any amount due hereunder, such breach may
be the basis of termination fourteen (14) Business Days following the date of
such notice, unless cured before the end of such notice period.
11.3 Insolvency or Bankruptcy. Either Party may, in addition to any other
remedy available by law or in equity, terminate this Agreement by written notice
to the other Party in the event such other Party shall have become insolvent or
bankrupt, or shall have an assignment for the benefit of its creditors, or there
shall have been appointed a trustee or receiver of such other Party or for all
or a substantial part of its property or any case or proceeding shall have been
commenced or other action taken by or against such other Party in bankruptcy or
seeking reorganization, liquidation, dissolution, winding-up, arrangement or
readjustment of its debts or any other relief under any bankruptcy, insolvency,
reorganization or other similar act or law of any jurisdiction now or hereafter
in effect, immediately, or there shall have been issued a warrant of attachment,
execution, restraint or similar process against any substantial part of the
property of such other Party, and any such event shall have continued for sixty
(60) days without either being dismissed, bonded or discharged. Both Party's
rights under this Agreement shall include, without limitation, those rights
afforded by 11 U.S.C. s.365(n) of the United States Bankruptcy Code (the
"Code") and any successor thereto, if applicable. If any bankruptcy trustee of
either Party, or such Party, as a debtor or debtor-in-possession, shall reject
this Agreement under 11 U.S.C. s.365(n) of the Code, the other Party may elect
to retain its rights licensed from such Party hereunder (and any other
supplementary agreement hereto) for the duration of this Agreement and avail
itself of all rights and remedies to the full extent contemplated by this
Agreement and 11 U.S.C. s.365(n) of the Code, and any other relevant law.
11.4 Termination for Severe Safety Reasons. Either Party shall have the
right to terminate this Agreement with respect to a particular Program Compound
or Product upon thirty (30) days written notice to the other Party if
non-clinical or clinical evidence about such Program Compound or Product
demonstrates a sufficiently serious adverse risk/benefit profile that further
Page 17 of 23
development or commercialization of such Program Compound or Products would be
permanently suspended by a regulatory authority or other authority of competent
jurisdiction.
11.5 No Diminution in Rights. The provisions under which this Agreement
may be terminated shall be in addition to any and all other legal or equitable
remedies that either Party may have for the enforcement of any and all terms
hereof, and do not in any way limit any other legal remedy such Party may have.
11.6 Effects of Termination.
11.6.1 Terminating Party's Rights. Upon termination of this
Agreement by either Party pursuant to Section 11.2 or 11.3, in addition to any
other right that the terminating Party may have at law or in equity:
(a) Any and all licenses granted to the terminating Party
under this Agreement shall remain in full force and effect as necessary to
enable the terminating Party to continue any Research Project initiated or
contemplated under this Agreement;
(b) The other Party shall be deemed to have assigned to the
terminating Party all rights the other Party has or may have to the Program
Compounds and Program Intellectual Property, including without limitation all
rights to develop, commercialize and obtain future, unaccrued payments with
respect to Program Compounds or Products;
(c) The other Party shall, at its sole expense, promptly make
available to the terminating Party copies of all data, reports, records and
materials, including, without limitation, all Program Compounds and Program
Intellectual Property, relating to the Program and return to the terminating
Party, or destroy at such Party's request, all relevant records and materials in
its possession or control containing Confidential Information of the terminating
Party; and
(d) The terminating Party may revoke any and all licenses
granted by it under this Agreement.
11.6.2 Accrued Obligations. Termination, relinquishment or
expiration of this Agreement for any reason shall be without prejudice to any
right that shall have accrued to the benefit of any Party prior to such
termination, relinquishment or expiration. Such termination, relinquishment or
expiration shall not relieve either Party from obligations that are expressly
indicated to survive termination or expiration of this Agreement. All
obligations not expressly indicated to survive termination or expiration of this
Agreement shall terminate upon the termination or expiration of this Agreement.
11.6.3 Survival. In addition to the provisions that survive by
implementation of this Section 11.6, all of the Parties' rights and obligations
under, and/or the provisions contained in, Sections 6.1 and 6.2 and Articles 8,
9, 10, 11 and 12 shall survive termination of this Agreement.
Page 18 of 23
ARTICLE 12
MISCELLANEOUS PROVISIONS
12.1 Entire Agreement; Amendment. This Agreement (including Exhibits A and
B) constitutes and contains the entire understanding and agreement of the
Parties respecting the subject matter of this Agreement and supersedes any and
all prior or contemporaneous negotiations, correspondence, understandings and
agreements between the Parties, whether oral or written, regarding such subject
matter. Any amendment or modification to this Agreement shall be made in writing
and signed by the Parties.
12.2 Further Actions. Each Party agrees to execute, acknowledge and
deliver such further instruments and to do all such other acts as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.
12.3 Binding Effect. This Agreement and the rights granted herein shall be
binding upon and shall inure to the benefit of Siga, TransTech and their
successors and permitted assigns.
12.4 Assignment. Neither Party may assign this Agreement without the prior
written consent of the other Party; provided, however, that either Party may
assign this Agreement without the prior written consent of the other Party in
connection with the sale or transfer of substantially all of its assets that
relate to this Agreement, or in the event of its merger or consolidation or
change of control or similar transaction, or to a wholly-owned Affiliate of such
Party, and as long as any permitted assignee shall assume all obligations of its
assignor under this Agreement. Any assignment in contravention of this Section
12.4 shall be void.
12.5 No Implied License. No right to any patent, know-how, technical
information or other Intellectual Property, other than as explicitly identified
herein, is granted or deemed granted by this Agreement.
12.6 Exports. The Parties acknowledge that the export of technical data,
materials or products is subject to the exporting Party receiving any necessary
export licenses and that the Parties cannot be responsible for any delay
attributable to export controls that is beyond the reasonable control of either
Party. Neither Party shall export or re-export, directly or indirectly, any
information, technical data, the direct product of such data, sample or
equipment received or generated under this Agreement in violation of any
governmental regulations that may be applicable. The Parties shall obtain
similar covenants from their Affiliates, sublicensees and contractors with
respect to the subject matter of this Section.
12.7 No Waiver. No waiver, modification or amendment of any provision of
this Agreement shall be valid or effective unless made in writing and signed by
a duly authorized officer of such Party. The failure of a Party to assert a
right hereunder or to insist upon compliance with any term or condition of this
Agreement shall not constitute a waiver of that right or excuse a similar
subsequent failure to perform any such term or condition.
12.8 Independent Contractors. The Parties are independent contractors
under this Agreement. Nothing contained in this Agreement is intended nor is to
be construed so as to
Page 19 of 23
constitute Siga or TransTech as mutual agents, partners or joint venturers with
respect to this Agreement or any transactions contemplated thereby. Except as
expressly provided in this Agreement, neither Party shall have any express or
implied right or authority to assume or create any obligation on behalf of or in
the name of the other Party or to bind the other Party to any other contract,
agreement or undertaking with any Third Party.
12.9 Force Majeure. Non-performance of either Party shall be excused to
the extent that performance is rendered impossible by strike, fire, flood,
governmental acts, acts of war or terrorism or any other similar reason where
failure to perform is beyond the reasonable control of and is not caused by the
negligence of the non-performing Party.
12.10 Notices and Deliveries. Any formal notice, request, delivery,
approval or consent required or permitted to be given under this Agreement shall
be in writing and shall be deemed to have been sufficiently given when it is
received, whether delivered in person, transmitted by facsimile with
contemporaneous confirmation, or delivery by registered letter (or its
equivalent) or delivery by certified overnight courier service, to the Party to
which it is directed at its address shown below or such other address as such
Party shall have last given by notice to the other Parties.
if to Siga, to:
Xxxxxx X. Xxxxx
Chief Scientific Officer
SIGA Technologies, Inc.
0000 XX Xxxxxxxx Xxx-- Xxxxx 000
Xxxxxxxxx, XX 00000
Fax: (000) 000-0000
with a copy to:
Xxxxxx X. Xxxxxxxxx, Esq.
Xxxxxx Xxxxx Xxxxxxxx & Xxxxxxx LLP
000 Xxxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Fax: (000) 000-0000
if to TransTech, to:
Adnan M.M. Mjalli, Ph.D.
President and CEO
TransTech Pharma, Inc.
0000 Xxxxxxxxxx Xxxx Xxxxxxx, Xxxxx 000
Xxxx Xxxxx, XX 00000
Fax: (000) 000-0000
Page 20 of 23
12.11 Public Announcements. The Parties will agree upon the timing and
content of any initial press release or other public communication relating to
this Agreement and the transactions contemplated herein.
12.12 Headings. The captions to the sections and articles in this
Agreement are not a part of this Agreement, and are included merely for
convenience of reference only and shall not affect its meaning or
interpretation.
12.13 Severability. If any provision of this Agreement becomes or is
declared by a court of competent jurisdiction to be illegal, unenforceable or
void, this Agreement shall continue in full force and effect without said
provision, so long as the Agreement, taking into account said voided
provision(s), continues to provide the Parties with the same practical economic
benefits as the Agreement containing said voided provision(s) did on the
Effective Date. If, after taking into account said voided provision(s), the
Parties are unable to realize the practical economic benefit contemplated on the
Effective Date, the Parties shall negotiate in good faith to amend this
Agreement to reestablish the practical economic benefit provided the Parties on
the Effective Date.
12.14 Applicable Law. This Agreement shall be governed by and interpreted
in accordance with the laws of the State of Delaware without reference to its
conflicts of laws provisions. The parties irrevocably consent to the
jurisdiction of the state and federal courts located in Delaware.
12.15 Counterparts. This Agreement may be executed in counterparts, or
facsimile versions, each of which shall be deemed to be an original, and both of
which together shall be deemed to be one and the same agreement.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed
by their respective duly authorized officers as of the Effective Date, each copy
of which shall for all purposes be deemed to be an original.
TRANSTECH PHARMA, INC.
By:/s/ Adnan M.M. Mjalli, Ph.D.
----------------------------------------
Name: Adnan M.M. Mjalli, Ph.D.
Title: President and Chief Executive Officer
SIGA TECHNOLOGIES, INC.
By:/s/ Xxx Xxxxxxxx
----------------------------------------
Name: Xxx Xxxxxxxx
Title: CFO/Acting CEO
Page 21 of 23
Exhibit A
Statement of Work
This Statement of Work is a part of the Research and License Agreement
between TransTech Pharma, Inc. ("TransTech") and SIGA Technologies, Inc.
("Siga") dated September , 2002 (the "Agreement"). All work to be performed
under this Statement of Work is subject to the terms and conditions of the
Agreement and no Statement of Work shall have full force and effect under the
Agreement unless all portions of such Statement of Work are completed and
executed in duplicate by both Parties.
1. Description of the Research Project, including the identity of the Screening
Target, criteria for display of biological activity against such Screening
Target, potential Program Compounds involved and the desired outcome:
2. The Research Project shall begin on .
3. Criteria for Program Compound:
4. The animal model(s) appropriate for the Research Project, including animal
efficacy model and identification of clinically viable route of administration:
5. Special responsibilities or activities of the Parties for this Program:
Dated this day of , 200 .
For Trans Tech Pharma, Inc. For SIGA Technologies, Inc.
By:________________________ By:___________________________
Title:_____________________ Title:________________________
Page 22 OF 23
Exhibit B
Proprietary Screening Targets of SIGA Technologies, Inc.
All biological agents covered by any of the following:
Pap D Compounds and Pharmaceutical Compounds for the Treatment or
Prophylaxis of Bacterial Infections, US Patent Application Serial No
08/640,877, US & PCT No. 6,420127
DegP Periplasmic Protease, A New Anti-infective Target and an
in-vitro Assay for DegP Protease Functions, US Patent Application
Serial No 60/140,990 XX & XXX Xx. 0,000000
X-Xxxxxx-xxxx Xxxxxxxxx Xxxxxxxxxx, XX Patent Application Serial No
60/075,264.
DegP Protease: Cleave Site Identification and Proteolysis of a
Natural Target in E. Coli, US Patent Application Serial No
60/330/855.
Screening Method for Orthopoxvirus Antiviral, US Patent Application
Serial No 60/345,646.
Page 23 of 23
