EXHIBIT 10.26
Research Collaboration Agreement
This Research Collaboration
Agreement (the “Agreement”) is made effective as of the
last date of the signatures below written (the “Effective
Date”) between Cordis Corporation , a Florida
corporation, with an address at 7 Powderhorn Drive, Warren, NJ
07059 (“Cordis”) and GenVec Inc., a Delaware
corporation, with an address at 65 West Watkins Mill Road,
Gaithersburg, MD 20878 (“GenVec”). Cordis will supply
NOGA Guided Myostar catheters to GenVec. GenVec desires to use such
Device for research purposes as described in the attached draft
clinical protocol outline (Appendix A) or as otherwise
provided in this Agreement.
|
|
|
WHEREAS, Cordis
is a manufacturer of intravascular medical devices;
|
|
|
|
|
|
|
|
WHEREAS, GenVec
is a developer of gene-based medicines; and
|
|
|
|
|
|
|
|
WHEREAS, Cordis
wishes for GenVec to undertake certain research studies using
Cordis’ Device (as defined below) and GenVec wishes to
conduct such research studies.
|
|
|
|
|
|
|
|
NOW, THEREFORE,
in consideration of the mutual promises and undertakings, the
parties agree as follows:
|
Section 1.
Definitions
|
|
A.
|
|
“Compound” shall mean, BIOBYPASS
® (Ad GV VEGF121.10), which is an
adenovector based on human adenovirus serotype 5 in which the E1
region is deleted from Ad5 bp 356 — 3510 and the E3 region is
partially deleted (GV10) containing the recombinant DNA sequence
for vascular endothelial growth factor 121 (“VEGF121”)
under control of the human cytomegalovirus immediate early
promoter. The VEGF121 expression cassette is placed in the E1
region of the GV10 vector in a rightward to leftward direction as
it relates to the rest of the adenovirus genome.
|
|
|
|
|
|
|
|
B.
|
|
“Confidential Information” shall
have the meaning set forth in Section 5A of this
Agreement.
|
|
|
|
|
|
|
|
C.
|
|
“Conflicting Transaction” shall mean
any contractual relationship with any third party concerning the
sale, license, issuance, assignment or other transfer to the third
party of any exclusive rights to any patents, patent applications
or any other intellectual property rights with respect to the
Compound for use in treating chronic cardiac ischemia.
|
|
|
|
|
|
|
|
D.
|
|
“Co-Principal Investigators” will be
selected and mutually agreed between Cordis and GenVec.
|
|
|
|
|
|
|
|
E.
|
|
“Cordis
Inventions” shall mean all Inventions conceived, reduced to
practice or otherwise developed solely by one or more employees of
Cordis in connection with the performance of the
Project.
|
|
|
|
|
|
|
|
F.
|
|
“Device” shall consist of a set
including the following disposable components: one (1) NOGA
MyoStar Injection Catheter; one (1) Mapping Catheter and one
(1) Patch. Device shall be essentially the same as used in
previous Phase I feasibility trial.
|
[*]=CERTAIN INFORMATION IN THIS
EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE
OMITTED PORTIONS.
1
|
|
G.
|
|
“GenVec
Inventions” shall mean all Inventions conceived, reduced to
practice or otherwise developed solely by one or more employees of
GenVec in connection with the performance of the
Project.
|
|
|
|
|
|
|
|
H.
|
|
“Inventions” shall mean inventions,
developments, discoveries, software, know-how, methods and
techniques.
|
|
|
|
|
|
|
|
I.
|
|
“Joint
Inventions” shall mean all Inventions conceived, reduced to
practice or otherwise developed by one or more employees of Cordis
and one or more employees of GenVec in connection with the
performance of the Project.
|
|
|
|
|
|
|
|
J.
|
|
“Principal Investigator” shall mean
* or a successor agreed between Cordis and GenVec.
|
|
|
|
|
|
|
|
K.
|
|
“Product” shall mean a combination
product that incorporates the Compound and the Device.
|
|
|
|
|
|
|
|
L.
|
|
“Project” shall mean the Phase II
OUS clinical research project entitled “A Multicenter,
Randomized, Double-Blind, Placebo-Controlled Study Evaluating
Efficacy of NOGA-Guided/ Myostar Catheter Delivery of BIOBYPASS (Ad
GV VEGF121.10) In “No Option” Patients With
Class III-IV Stable Angina” outlined in Appendix A
attached hereto and incorporated herein (as such project may be
modified as provided in this Agreement), which shall be performed
under the direction of the Principal Investigator and Co-Principal
Investigators.
|
|
|
|
|
|
|
|
M.
|
|
“Term” shall have the meaning set
forth in Section 9A of this Agreement.
|
Section 2. Research
Work
|
|
A.
|
|
GenVec and
Cordis shall use reasonable efforts to perform their respective
obligations concerning the Project in a professional and
workmanlike manner and substantially in accordance with the terms
and conditions of this Agreement, including, without limitation,
the milestones described in Appendix B. Cordis and GenVec
shall, promptly after the execution of this Agreement, finalize the
clinical protocol for the Project to take into account any changes
to Appendix A required or suggested by regulatory authorities
or agreed upon by the parties, and may, at any time, amend such
protocol by mutual written agreement. Cordis shall not unreasonably
withhold or delay its agreement to any such changes proposed by
GenVec.
|
|
|
|
|
|
|
|
B.
|
|
The parties
shall select and agree upon the Co-Principal Investigators in time
to complete the first milestone provided in Appendix B at the
time set forth in Appendix B. Cordis shall not unreasonably
withhold or delay its agreement to any Co-Principal Investigator
proposed by GenVec.
|
Section 3. Reports and
Meetings
|
|
A.
|
|
An intermediate
report (the “Intermediate Report”) shall be submitted
by GenVec within one (1) month of completion of the interim
analysis of data, as described in Appendix B.
|
|
|
|
|
|
|
|
B.
|
|
A final report
shall be submitted by GenVec within one (1) month of completion of
the Project (the “Final Report”) that shall in
reasonable detail set forth GenVec’s findings and conclusions
about the Project, including, without limitation, the Product, and
be accompanied by all primary and secondary end point data
generated in the performance of the Project.
|
2
|
|
C.
|
|
During the
Term, neither party shall unreasonably refuse the other
party’s request to meet with representatives of the other
party at times and places mutually agreed upon to discuss the
Project.
|
3
Section 4. Cordis Payments
and Support.
|
|
A.
|
|
Cordis shall
provide Devices to support the Project *. Delivery of such Devices
shall be made by Cordis to GenVec, the Principal Investigator or
Co-Principal Investigators, as and when required for performance of
the Project, DDP (Incoterms 2000) the location where the Devices
are to be used. Cordis warrants that such Devices shall be free
from defects in materials and workmanship and conform to the
specifications therefor.
|
|
|
|
|
|
|
|
B.
|
|
*, Cordis shall
provide reasonable training and support in the use of the Devices
to the clinical sites for the Project, at such sites, as and when
required for performance of the Project.
|
|
|
|
|
|
|
|
C.
|
|
Cordis shall
provide reasonable clinical and regulatory expertise to support
GenVec in its interactions with the Principal Investigator and
Co-Principal Investigators and efforts to obtain regulatory
approvals within Europe and the U.S.
|
|
|
|
|
|
|
|
D.
|
|
Cordis shall
pay GenVec $* within 30 days of execution of this Agreement
for GenVec to perform the Project.
|
|
|
|
|
|
|
|
E.
|
|
To the extent
that GenVec’s costs of the Project exceed $*. GenVec shall
invoice Cordis for its share of such excess costs from time to
time, and Cordis shall pay the invoiced amounts within * days after
GenVec’s invoice. Prior to Cordis’ obligation to pay
any additional moneys, GenVec must provide Cordis written notice
that GenVec’s costs of the Project are to exceed $* and
provide Cordis with an accounts summary of how the original $* was
spent. If Cordis determines in reasonable good faith that the
original $* was not spent as mutually agreed to in the budget or in
a reasonable prudent manner, Cordis shall have the right to
terminate this Agreement by written notice to GenVec within
30 days after Cordis’ receipt of GenVec’s notice
and accounts summary.
|
|
|
|
|
|
|
|
F.
|
|
If Cordis fails
to make any payment when due, unless Cordis has a reasonable basis
to contest the payment and has notified GenVec thereof, GenVec may
accrue and charge interest on such late payments at the rate of 1%
per month from the date the payment was due until the date
paid.
|
|
|
|
|
|
|
|
G.
|
|
While it is
understood that Cordis is free to enter into other research
agreements with third parties that are otherwise similar to this
Agreement, Cordis agrees that during the Term of this Agreement it
shall not enter into any new collaborative agreement with a third
party in which the focus of the agreement is research concerning
*.
|
Section 5.
Confidentiality
|
|
A.
|
|
During the
Term, the parties may provide each other with confidential
information and materials including, but not limited to, data,
drawings, models, processes, trade secrets and devices
(“Confidential Information”). The parties confirm that
the reports and data provided under Section 3 are Confidential
Information of GenVec.
|
|
|
|
|
|
|
|
B.
|
|
A party
receiving Confidential Information from the other party shall not
disclose any Confidential Information of the other party to any
third party, nor use the same for its own benefit, nor permit its
use for the benefit of others without the prior written consent of
the disclosing party. Notwithstanding the foregoing, a party may
use Confidential Information of the other party for performance of
the Project and for other purposes relating to development of the
Product and disclose Confidential Information of the other party to
its employees and contractors who are involved in such activities
and who have undertaken, in writing, obligations of confidentiality
comparable in scope to those set forth in this
Agreement.
|
4
|
|
C.
|
|
The obligations
of confidentiality assumed by the parties hereunder shall not apply
to any information which:
|
|
|
|
|
|
|
|
i.
|
|
was known by
the receiving party before disclosure by the other party, as
evidenced by prior written records;
|
|
|
|
|
|
|
|
ii.
|
|
becomes
published or otherwise generally known to the public through no
fault of the receiving party;
|
|
|
|
|
|
|
|
iii.
|
|
was rightfully
obtained by the receiving party from a third party under no
obligation to the disclosing party not to disclose the
information;
|
|
|
|
|
|
|
|
iv.
|
|
is developed by
the receiving party independently of disclosures made under this
Agreement or other confidential disclosures by the disclosing
party; or
|
|
|
|
|
|
|
|
v.
|
|
is required by
law to be non-confidentially disclosed by the receiving party,
provided that the receiving party gives the disclosing party prior
written notice before its disclosure and cooperates with the
disclosing party in efforts to limit or minimize the effects of the
disclosure.
|
|
|
|
|
|
D.
|
|
The
parties’ obligations of confidentiality with respect to
Confidential Information shall continue for a period of three years
from the expiration or termination of this Agreement.
|
Section 6. Ownership and
Publication of Data
|
|
A.
|
|
Subject to the
provisions of Section 7, the data generated in the performance
of the Project shall be owned jointly by Cordis and GenVec. The
parties recognize that the results of the Project may be
publishable. Subject to the provisions of this Agreement, GenVec,
and with GenVec’s consent the Principal Investigator and
other investigators engaged in the Project, shall be permitted to
present at symposia and other professional meetings, and to publish
in journals, theses, dissertations or otherwise, the methods and
results of the Project, in the form of presentations, journal
articles, papers or otherwise.
|
|
|
|
|
|
|
|
B.
|
|
GenVec shall
furnish Cordis with two copies of any proposed publications or
presentations at least forty-five (45) days before their
submission for publication or presentation or as far in advance as
is reasonably possible. Cordis shall have forty-fine (45) days
after receipt of said copies to o
|
|