SPONSORED RESEARCH AGREEMENT
This
SPONSORED RESEARCH AGREEMENT (“Agreement”), is entered into effective January
12, 2007, by and between ROSWELL
PARK CANCER INSTITUTE CORPORATION
(“Sponsor”), Xxx & Xxxxxxx Xxxxxxx, Xxxxxxx, XX 00000 and CLEVELAND
BIOLABS, INC. (“CBL”).
WHEREAS,
CBL
is a
biomedical research organization, engaged primarily in research and development
of compounds, drugs, vaccines and other health care preventive and therapeutic
materials relating to cancer and radiation biology; and
WHEREAS,
CBL
employs researchers with training and expertise in these areas for the purpose
of conducting research and studies in order to identify, discover and develop
technologies and inventions and to enter into relationships with academic
medical centers and cancer research facilities to conduct clinical research
studies; and
WHEREAS,
Sponsor
is a National Cancer Institute-designated Comprehensive Cancer Center, which
sponsors and conducts clinical trials of investigational drugs, devices and
processes relating to the treatment, diagnosis and prevention of cancer and
related conditions, which clinical trials are submitted for approval to
Sponsor’s Institutional Review Board (“IRB”) and are managed and administered by
its Office of Clinical Research Services (“OCRS”); and
WHEREAS,
Sponsor
is, and CBL is to be, located on the Buffalo Niagara Medical Campus, in Buffalo,
New York, which provides excellent proximity to facilitate collaborations in
each party’s principal areas of research; and
WHEREAS,
Xxxxxx
Xxxxxx, Ph.D., the Chairman of Sponsor’s Department of Cell Stress Biology and
Senior Vice President for Research Development, has played a primary role as
an
investigator on several of CBL’s most promising research projects in which
Sponsor has a research interest; and
WHEREAS,
Sponsor
and CBL anticipate entering into a separate agreement governing the licensing
of
certain technologies from Sponsor to CBL (the “License Agreement”); and
WHEREAS,
Sponsor
and CBL believe there to be a unique synergy in their respective capabilities
of
developing and providing treatment to cancer patients using innovative
biomedical approaches; and
WHEREAS,
Sponsor
and CBL desire to enter into this Agreement to provide the terms and conditions
upon which Sponsor will provide funding for CBL to conduct research studies
for
individual study projects of interest to Sponsor and to further collaborative
research and educational opportunities with Sponsor’s faculty and staff.
Now,
therefore, the parties agree as follows:
1. Grant
Funding.
Sponsor
shall provide a funding grant (the “Grant”) to CBL in the total amount of Three
Million Dollars ($3,000,000.00) to be used by CBL as outlined in this Agreement
and to support its overhead infrastructure relating to the activities outlined
in this Agreement. Such Grant funds shall be distributed in accordance with
the
schedule attached as Exhibit 1. The Grant fund installment to be released April
1, 2008 shall be released upon attainment of pre-agreed milestones showing
progression of research, provided, however, the parties may agree upon
alternative allocation of funds to other programs of CBL where research progress
is more likely. CBL shall use Grant funds to pay for direct and indirect costs
of the activities described below, including overhead necessary to support
such
activities and for general overhead of CBL meeting the requirement of
reasonableness and business necessity:
a.
to
continue CBL’s primary research programs in cancer treatment, radiation biology
and radiation injury protection, cancer prevention, development of treatment
modalities and compounds and innovative therapeutic approaches to supportive
care by tissue protective agents pioneered by CBL (“Research Activities”);
b.
to
collaborate with Sponsor on research studies, programs and initiatives of mutual
interest and to provide Sponsor with the right of first refusal to conduct
studies and trials emanating from CBL’s Research Activities at Sponsor’s
facility as the primary site, provided that Sponsor’s facilities are an
appropriate location for such activities (“Collaborative Activities”);
and
c.
to
provide training and educational opportunities for students of Sponsor’s
graduate education programs, as well as other science and translational research
trainees both at CBL’s facility and Sponsor’s campus and to provide consulting
services to Sponsor in connection with its small molecule drug screening,
without charge (other than out-of-pocket costs incurred by CBL), upon reasonable
request of Sponsor (“Educational and Consultative Services”).
While
the
purpose of this Agreement, and Sponsor’s funding of CBL’s programs, is to
encourage and to facilitate CBL’s Research Activities of interest to Sponsor, to
enhance Collaborative Activities, and to promote Educational and Consultative
Services for Sponsor’s faculty and staff members, the Parties acknowledge that,
by entering into this Agreement, Sponsor is under no obligation to propose
any
studies to CBL and CBL is under no obligation to accept any studies proposed
by
Sponsor.
2. Research
Activities.
CBL’s
basic research shall be conducted in accordance with CBL’s policies and rules
governing its research activities. Any studies or trials conducted by CBL with
Grant funding pursuant to this Agreement shall be referred to hereafter as
the
“Sponsored Studies”. CBL will disclose to Sponsor the specific details of each
proposed Sponsored Study at least sixty (60) days before such study will
commence. CBL shall review the details of the proposed study with Sponsor’s
senior scientific leadership to determine appropriateness for utilization of
Grant funding for such study, and shall notify CBL of any proposed modifications
within thirty (30) days following disclosure by CBL of the details relating
to
the proposed study. CBL shall provide written research result reports and status
updates to Sponsor on Research Activities funded by Grant funds under this
Agreement, not less often than annually and upon any substantial modifications
of any Sponsored Study, such reports to be subject to confidentiality
requirements binding Sponsor’s personnel.
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3. Collaborative
Activities.
CBL
agrees that, subject to Section 12, for Collaborative Activities related to
treatment of cancer patients, it will use commercially reasonable efforts to
facilitate establishment of collaborative relationships for such research with
Sponsor’s faculty, to the extent that such relationships are appropriate or
suitable for collaboration with Sponsor.
With
respect to any trials emanating from CBL’s Research Activities (regardless of
whether such trials are “Sponsored Studies”, as that term is defined above), CBL
shall provide Sponsor the right to be the primary site for such trial. CBL
shall
provide Sponsor with all requirements (including, without limitation, financial,
timing, facilities, and regulatory requirements) appropriate and feasible to
conduct such trial so that Sponsor can evaluate whether it will be appropriate
and feasible to conduct each such study at Sponsor’s facility utilizing
Sponsor’s faculty and clinical trial resources. Sponsor shall advise CBL within
thirty (30) days as to whether it desires to have the trial conducted at its
facility, and in those instances in which Sponsor so desires, it will identify
the principal investigator (“Investigator”) from Sponsor’s faculty; who will
confer with CBL to develop proposed trial objectives, activities, costs and
timelines. Studies
and trials conducted at Sponsor’s facilities shall be considered “Collaborative
Studies”. CBL
and
Sponsor shall jointly prepare budgets and protocols for Collaborative
Studies. CBL
shall
allocate funds (Grant funds in the case of Sponsored Studies) to cover the
parties’ expenses relating to Collaborative Studies in accordance with the
jointly prepared budgets. The parties agree to negotiate the terms of
Collaborative Studies in good faith and in accordance with the customs of the
industry. Such terms shall describe the scope of work, delineation of
responsibilities, funding, ownership of data, and rights relating to
publications and intellectual property. If Sponsor is unable or declines to
have
a trial conducted at its facility, CBL may enter into agreements with
third-parties to conduct the study on terms that are no more favorable to the
third party than those offered to Sponsor. In the event that CBL seeks to pursue
trials at several sites or locations, the foregoing shall not preclude CBL
from
contracting with other sites to conduct such trials. CBL’s obligation to offer
Sponsor the right to conduct studies shall not apply to any studies that were
initiated or developed by CBL prior to execution of this Agreement.
With
respect to any Collaborative Studies involving human or animal subjects, the
parties agree to conduct such studies in compliance with any and all applicable
federal, state, and local laws, regulations and guidelines, good clinical
practices, and specifically in accordance with the applicable Statement of
Investigator, U.S. Food and Drug Administration (FDA) Form 1572,
as
described in 21 C.F.R. 312.53, which Investigator will complete, sign, and
deliver to Sponsor prior to the commencement of a study at CBL (unless the
study
is a non-U.S. or device-related study in which a Form 1572 is not required).
A
copy of each signed Investigator’s statement and any protocol amendments will be
maintained in the files of each party. The scope and nature of any Collaborative
Studies to be performed in which human subjects are involved (or may be
involved), will be developed collaboratively by Sponsor and CBL. The protocol
will detail the clinical research activities and responsibilities to be
undertaken, pursued, and followed by CBL. The protocol will be considered final
after it is signed by Sponsor, CBL and the Investigator and approved by the
pertinent IRB and/or Ethics Committee (“EC”) (hereinafter, the “IRB/EC”).
Thereafter, the protocol may be amended only by prior written consent of Sponsor
and of CBL and subsequent approval by the pertinent IRB/EC or other governing
regulatory authorities.
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4. Educational
and Consultative Services.
CBL
will provide training and educational opportunities for students of Sponsor’s
graduate education programs, as well as other science and translational research
trainees both at CBL’s facility and Sponsor’s campus. CBL faculty will
participate in Sponsor’s symposia, educational programs, science advisory and
training committees, as reasonably requested and upon reasonable notice provided
by Sponsor, with due respect for existing commitments and obligations of CBL’s
personnel. CBL will also provide consulting service to Sponsor in connection
with its small molecule drug screening, without charge (other than out-of-pocket
expenses incurred by CBL), upon request of Sponsor.
5. Role
of Sponsor Personnel.
The
parties acknowledge that Xxxxxx Xxxxxx, Ph.D. is the Chairman of Sponsor’s
Department of Cell Stress Biology and Senior Vice President for Research
Development, and is also a consultant and equity owner of CBL. Xx. Xxxxxx shall
participate in research activities of CBL in his capacity as an officer and
employee of CBL on his personal time and not on his employment time with
Sponsor. Xx. Xxxxxx may participate in Collaborative Activities between Sponsor
and CBL, and shall do so exclusively in his capacity as an employee and faculty
member of Sponsor subject to the terms and conditions of the License Agreement
and Section 16.
6. Term.
This
Agreement shall be effective as of the date it is signed by both parties and
shall continue for an initial period of five (5) years unless terminated in
accordance with the provisions set forth in Paragraph 15 (Termination of
Agreement). Renewal and extension of this Agreement may occur at any time with
the written consent of both parties.
7. Confidential
Information.
Study
data, reports and/or information directly arising from the Research Activities
conducted by CBL, including any studies related thereto, will constitute
Confidential Information and will not be provided by CBL to any parties not
involved in the conduct of the study other than (a) Sponsor; (b) in confidence
to the IRB/EC and SRC (Scientific Review Committee); (c) as permitted by
Paragraph 8 (Publication) of this Agreement; (d) in the course of any study,
as
necessary, in Sponsor’s reasonable medical judgment for the care of any patient
participating in the study; (e) as is necessary or appropriate to satisfy CBL’s
reporting obligations pursuant to regulations promulgated by the Securities
and
Exchange Commission, any securities exchange or quotation service, or such
other
governmental or quasi-governmental authority to which CBL is subject; (f) as
required by law pursuant to a court order, subpoena or similar document
compelling disclosure or necessary for protection of the disclosing party’s
interests against lawsuits, allegations of scientific misconduct, conflict
of
interest actions, patent infringement and interference proceedings and similar
circumstances, provided prior notice of such compelled disclosure is given
to
the other party in sufficient time to permit such party to pursue a protective
order.
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Except
as
otherwise permitted under this Agreement, each party agrees to maintain in
confidence all of the Confidential Information and not disclose or disseminate
it to any third party or use it for any purpose other than the performance
of
research activities and in furtherance of the purposes of this Agreement. Except
as otherwise permitted under this Agreement, such Confidential Information
shall
be disclosed only on a need-to-know basis and only to a party’s employees and
agents, to other required group members (e.g., Clinical and Scientific Protocol
Review Committee, Data Safety Monitoring Boards, Legal Departments). The
foregoing obligation of nondisclosure shall survive termination or expiration
of
this Agreement for a period of five (5) years. Confidential Information does
not
include information that:
(a) is
or
becomes publicly available through no fault of the disclosing
party;
(b) is
known
to the disclosing party prior to disclosure hereunder, as shown by prior written
records;
(c) is
necessary to obtain IRB/EC approval of a study or that must be included in
any
patient’s written informed consent form.
(d) can
be
documented to have been independently developed by the disclosing party by
someone without access to Confidential Information and not involved in the
study
to which the Confidential Information relates and without use or reference
to
the Confidential Information;
(e) is
published by the disclosing party or its employees in accordance with
Paragraph 8 (Publication) herein; or
(f) is
required for purposes of securing patents or research grants, provided that
the
party seeking to secure a grant or patent provides the other party with thirty
(30) days advance notice prior to disclosing information to secure such grant
or
patent.
4
8 Publication.
CBL
will retain ownership of data generated by its Research Activities and shall
retain the right to determine whether to publish results of its Research
Activities. Notwithstanding the foregoing, the parties agree that results of
Sponsored Studies and Collaborative Studies are intended to be of publishable
quality and Investigators employed by Sponsor or by CBL are permitted to present
at symposia, national or regional professional meetings and to publish in
journals, theses or dissertations, the methods and results of the research
or
the study in a manner coordinated by and among the contributing Investigators.
CBL understands and agrees that participation in a study may involve a
commitment to publish the data from the study in a collaborative publication
with other Investigators prior to publication or public presentation of efficacy
and safety results. Before either party makes any publication or other public
disclosure of any technology or data developed in connection with the Sponsored
Studies or Collaborative Studies, the party proposing such disclosure will
send
the other party a copy of the information to be disclosed, and will allow the
other party sixty (60) days from receiving it to determine whether the
information to be disclosed contains subject matter for which patent protection
should be sought before disclosure, or otherwise contains Confidential
Information of the reviewing party. The party proposing disclosure will be
free
to proceed with the disclosure unless before the expiration of such sixty (60)
day period, the reviewing party notifies the party proposing disclosure that
the
disclosure contains (1) subject matter for which patent protection should be
sought and/or (2) Confidential Information of the reviewing party, and the
party
proposing publication will then delay public disclosure of the information
of an
additional period to be mutually agreed upon to permit the preparation and
filing of a patent application on the subject matter to be disclosed or for
the
parties to determine a mutually acceptable modification to the publication
to
protect adequately the Confidential Information of the reviewing party. The
party proposing disclosure will afterwards be free to publish or disclose the
information. The determination of authorship for any paper will be in accordance
with accepted scientific practice. At least one reprint of each published paper
should be submitted to the Sponsor.
CBL will
not enter into any arrangements with third-parties that permit the third party
to edit, modify, or delay any publication covered by this provision or restrict
the publication rights set forth in this Agreement without the prior written
consent of Sponsor.
CBL
shall
ensure that anyone listed on a research paper should accept full responsibility
for ensuring that he/she is familiar with the contents of the paper and can
identify his/her contribution to it. The contribution of formal collaborators
and all other others who directly assist or indirectly support the Research
should be properly acknowledged. Sponsor
should be notified in advance when study results might be published, publicized
or disseminated.
9. Location
of CBL Business. As
further consideration for the grant funding provided hereunder by Sponsor,
CBL
agrees that it will locate its headquarters and research facilities at the
Buffalo Niagara Medical Campus, specifically at 00 Xxxx Xxxxxx, Xxxxxxx, XX,
and
that it shall, during the term of this Agreement, maintain a majority of its
research and in-house commercial activities within the Western New York region.
Additionally, during the term of this Agreement, CBL will use commercially
reasonable efforts to maintain a majority of the commercial activity that it
contracts to third-parties within the Western New York region. The purpose
of
this representation is to maximize opportunities for collaborative research
and
discovery between Sponsor and CBL, and also to enhance job creation activities
in Western New York in recognition of the role played by the New York State
Government in facilitating this Agreement.
5
During
the period of time in which CBL’s activities are located at the Buffalo Niagara
Medical Campus CBL shall have access to Sponsor’s core laboratory resource
facilities at Sponsor’s standard fee schedule.
10. Independent
Contractors.
CBL
shall act as an independent contractor of Sponsor and shall not be construed
for
any purpose as the partner, agent, employee, servant, or representative of
Sponsor. Sponsor is not responsible for any employee benefits, pensions,
workers’ compensation, withholding, or employment related taxes as to CBL. CBL
shall not enter into any contract or agreement with a third party that purports
to obligate or bind Sponsor, and Sponsor shall not enter into any contract
or
agreement with a third party that purports to obligate or bind CBL.
11. Third
Party Beneficiaries.
No
party, other than Sponsor and CBL shall be entitled to any rights whatsoever
by
virtue of the relationships created by or arising under this Agreement,
including, without limitation, rights as a third party beneficiary.
12. Pre-Existing
Obligations.
Sponsor
acknowledges the existence of a license between CBL and the Cleveland Clinic
Foundation dated July 1, 2004, relating to technology developed by CBL (the
“CCF
License”). Sponsor acknowledges and agrees that the terms of this Agreement
shall not require CBL to take any action or to refrain from taking any action
that would constitute a breach of the CCF License. Sponsor further acknowledges
and agrees that Sponsor shall have no right or title to, or interest in, any
development or research that is directly subject to the CCF
License.
13. Debarred
Status.
CBL
certifies by signing this Agreement that neither it nor its principals is
presently barred, suspended, proposed for debarment, declared ineligible, or
voluntarily excluded from participation in this transaction by any Federal
department or agency. In the future, should CBL or any of its principals be
barred, suspended, proposed for debarment, declared ineligible, or voluntarily
excluded from participation, CBL will promptly notify Sponsor.
14. Accounting
for Utilization of Funding. CBL
agrees to record and document all expenditures made utilizing Grant funding
provided by Sponsor under this Agreement, in order to permit an accurate
accounting of such expenditures should an accounting be undertaken by Sponsor
as
provided below. Further, within sixty (60) days after the end of each of its
fiscal years during the term of this Agreement, CBL shall provide a written
accounting to Sponsor documenting each expenditure in excess of $10,000.00
of
Grant funds provided by Sponsor under this Agreement. Sponsor shall have the
right, exercisable not more often than twice each calendar year, to audit the
books and records of CBL and to specifically audit those records of CBL relating
to receipt and expenditure of funding provided under this Agreement. The purpose
of such audit is to verify that CBL has spent or otherwise applied such funding
in compliance with the terms of this Agreement. Such audit shall be at Sponsor’s
sole cost, and shall be undertaken upon reasonable prior written notice to
CBL
and in a manner so as to minimize disruption of CBL’s business activities. CBL
agrees to provide full cooperation to Sponsor’s auditors acting under this
Agreement. In the event such audit discloses a substantial failure on the part
of CBL to make expenditure of grant funds in compliance with this Agreement,
in
addition to remedies for breach of this Agreement provided under law and in
this
Agreement, Sponsor shall have the right to be reimbursed by CBL for the cost
of
the audit disclosing such failure. For purposes hereof, a substantial failure
shall mean a failure or series of related failures involving greater than ten
(10%) percent of the funds expended during the year being audited.
6
15 Termination
of Agreement.
This
Agreement is subject to termination prior to its expiration in the event any
of
the following occurs:
| (a) |
In
the event of a breach by a party of a material provision of this
Agreement, which breach is not corrected within twenty (20) days
of
written notice of such breach given by the non-breaching party, the
non-breaching party may then elect to terminate the
Agreement;
|
| (b) |
In
the event of the bankruptcy or declared insolvency of a party to
the
Agreement, the other party may declare the Agreement
terminated;
|
| (c) |
Automatically,
if a party becomes debarred by the United States Government from
participating in Federal granting programs;
or
|
| (d) |
Upon
mutual agreement of the parties to terminate the
Agreement.
|
In
the
event this Agreement due to a default by CBL in its material obligations or
in
the event CBL becomes debarred resulting in termination as in Section 15 (c),
CBL shall repay to Sponsor all of the Grant funds paid to CBL pursuant to this
Agreement, such repayment to be made in full within thirty (30) days of CBL’s
receipt of a written demand for repayment from Sponsor. In addition, Sponsor
shall retain any and all other rights and remedies it may have under law or
equity for damages or other recourse against CBL for breach of this
Agreement.
16 Patent
Rights and Inventions.
(a) It
is
recognized and understood that certain existing inventions and technologies
are
the separate property of Sponsor or CBL and are not affected by this Agreement,
and neither party shall have any claims to or rights in such separate inventions
and technologies including, without limitation, inventions and technologies
derived from the CCF License. Any new invention, development, or discovery
under
this Agreement (“Invention”) resulting from Collaborative Activities and
Educational and Consultative Services shall be promptly disclosed in writing
to
both CBL and Sponsor. Inventorship of any such Invention shall be determined
in
accordance with patent law, or by mutual agreement based upon the relative
contributions of the parties if the Invention is not patentable. Title to
Inventions shall reside with Sponsor if Sponsor personnel are the sole
inventors, with CBL if CBL personnel are the sole inventors (“Sponsor
Inventions”), and will be held jointly if both CBL and Sponsor personnel are
inventors (“Joint Inventions”). Protection of proprietary rights through patent
or other processes, and promotion of commercialization of jointly owned
discoveries and inventions shall be as mutually agreed by the parties.
7
(b) CBL
shall
have the option to license, on an exclusive basis, the right to develop for
commercial purposes any Sponsor Inventions and Sponsor’s interests in any Joint
Inventions by notifying Sponsor within sixty (60) days after receiving the
written disclosure of Invention set forth in Section 16(a). Such licenses will
be negotiated by the parties on commercially reasonable terms. Sponsor shall
retain the right to use the Sponsor Inventions and its interests in any Joint
Inventions for academic or research purposes only.
17 Indemnification.
The
parties agree as follows:
(a) Each
party shall indemnify, defend and hold harmless the other party, including
such
party’s directors, officers, medical and professional staff, employees (the
“Indemnitees”), against any liability, damage, loss or expense (including
reasonable attorney's fees and expenses of litigation) incurred by or imposed
upon the Indemnitees or any one of them in connection with any claims, suits,
actions, demands or judgments arising out of the negligent acts or misconduct
of
the party providing such indemnification.
(b) The
indemnification under (a) above shall not apply to any liability, damage, loss
or expense to the extent that it is directly attributable to the negligent
activities, reckless misconduct or intentional misconduct of the
Indemnitees.
(c) Indemnification
under this provision is limited to the extent permitted by law.
(d) A
party
seeking indemnification under this section shall, as a condition of receiving
such indemnity, promptly notify the party from whom indemnification is sought
as
to any such claim, suit or action and will cooperate in the defense of such
claim, suit or action.
(h) The
provisions regarding indemnification shall survive the termination of this
Agreement for a period of five (5) years.
18. Complete
Agreement, Amendment.
The
parties agree that this Agreement together with the License Agreement
constitutes the sole, full, and complete agreement by and between the parties
and supersedes all other written and oral agreements and representations between
the parties with respect to the subject matter hereof. No amendments, changes,
additions, deletions, or modifications to or of this Agreement or any research
project plan shall be valid unless reduced to writing and signed by the parties.
Any requests for changes or amendments or other notices or communications
concerning this Agreement should be in writing or shall be deemed to have been
given when mailed by U.S. Mail postage prepaid or bonded courier and forwarded
to the following:
8
|
To
CBL:
|
President
and Chief Executive Officer
|
|
Cleveland
BioLabs, Inc.
|
|
|
00000
Xxxxx Xxxxxx, Xxxxx 000
|
|
|
Xxxxxxxxx,
Xxxx 00000
|
|
|
To
Sponsor:
|
President
and Chief Executive Officer
|
|
Roswell
Park Cancer Institute
|
|
|
Xxx
& Xxxxxxx Xxxxxxx
|
|
|
Xxxxxxx,
Xxx Xxxx 00000
|
|
|
With
copy to:
|
|
|
General
Counsel
|
|
|
Roswell
Park Cancer Institute
|
|
|
Xxx
& Xxxxxxx Xxxxxxx
|
|
|
Xxxxxxx,
Xxx Xxxx 00000
|
19 Binding
Effect.
This
Agreement shall be binding upon the parties, their successors, and assigns.
20 Waiver
and Severability.
Failure
to insist upon compliance with any of the terms and conditions of this Agreement
shall not constitute a general waiver or relinquishment of any such terms or
conditions, and the same shall remain at all times in full force and effect.
If
any part of this Agreement is held unenforceable by a court of competent
jurisdiction, such unenforceable provision shall be reformed and enforced to
the
extent such court determines permissible, and the remaining portions of the
Agreement will nevertheless remain in full force and effect.
21. Assignment.
Neither
party shall assign or transfer any of its rights or obligations under this
Agreement hereto without the written consent of the other, which consent will
not unreasonably be withheld, except that either party may assign its rights
and
delegate its obligations to an entity that it controls, is controlled by, or
under common control with. For purposes of this Agreement, “control” shall mean
the power to control the management or policies of an entity whether by
ownership, contract or otherwise.
22 Miscellaneous
Terms.
CBL
hereby represents, warrants and agrees as follows:
(a) CBL
shall, at its sole cost and expense procure and maintain comprehensive general
liability insurance in amounts not less than one million dollars ($1,000,000)
per occurrence and one million dollars ($1,000,000) annual aggregate, and shall
provide Sponsor with written evidence of the insurance and a copy of the policy
upon request. CBL will give notice to Sponsor at least thirty (30) days prior
to
cancellation or non-renewal of the insurance.
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(b) CBL
will
comply with all material federal, state, local and foreign laws, ordinances,
rules and regulations applicable to the manufacture and production of drugs,
biologics and devices or shipments in interstate or foreign
commerce.
23.
Change
of Law.
Notwithstanding any other provision of this Agreement, if during the term hereof
any Change of Law (defined below) results in an Adverse Consequence (defined
below), the parties agree to negotiate in good faith to make reasonable
revisions to this Agreement in order to avoid such Adverse Consequence(s) while
seeking to maintain the parties as close as possible to their original positions
despite such revisions. Upon notice by one party to the other of such Change
of
Law, the parties agree that they shall attempt to resolve the matter within
thirty (30) days of such notice. If the parties cannot agree upon renegotiated
terms hereunder within thirty (30) days, then this Agreement will terminate
upon
thirty (30) days notice by one party to the other of an inability to agree.
(a) As
used
herein, “Change of Law” shall mean: (i) any new legislation enacted by the
federal or any state government; (ii) any new third party payor or governmental
agency law, rule, regulation, guideline or interpretation of a previously issued
law, rule, regulation or guideline, or (iii) any judicial or administrative,
order or decree.
(b) As
used
herein, “Adverse Consequence” shall mean a Change of Law that prohibits,
restricts, limits or otherwise affects either party's rights or obligations
hereunder in an adverse material manner.
24 Effective
Upon Execution. This
Agreement shall not be considered accepted, approved, or otherwise effective
until signed below by the appropriate parties. Each of the parties hereto
represents and warrants that the person signing below on such party’s behalf has
the authority to enter into this Agreement, and that this Agreement does not
violate any existing agreement or obligation of such party
25. Non-Discrimination. CBL
will
comply with Title VI of the Civil Rights Act of 1964 (P.L. 88-352) and Executive
Order 11246, Title IX of the Education Amendment of 1972 (P.L. 92-318, 20 USC
1681 et seq.), Section 504 of the Rehabilitation Act of 1973 (29 USC 794),
and
the Age Discrimination Act of 1975 (P.L. 4-135). CBL shall furnish Sponsor
with
copies of their assurance of compliance for the above upon request.
10
IN
WITNESS WHEREOF and
intending to be legally bound hereby, the parties have caused this Agreement
to
be executed the date and year above first mentioned.
For
Cleveland BioLabs, Inc.:
|
/s/
Xxxxxxx Xxxxxxxx
|
||||
|
(Signature) |
||||
| Name: |
Xxxxxxx
Xxxxxxxx
|
|||
| Title: |
Chief
Executive Officer
|
|||
| Date: |
January
11, 2007
|
For
Roswell Park Cancer Institute Corporation:
| /s/ Xxxxx X. Xxxx | ||||
|
(Signature) |
||||
| Name: | Xxxxx X. Xxxx, MD | |||
| Title: | President and Chief Executive Officer | |||
| Date: | January 11, 2007 |
11
Exhibit
1.
Schedule
of Payments
The
funding provided by Sponsor shall be provided to CBL in two (2) installments
with the first of such installments in the amount of two million dollars
($2,000,000) being made April 1, 2007, and the second and final installment
in
the amount of one million ($1,000,000) being made April 1, 2008.
12
