exv10w26



 


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® (AdGV 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.


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	 	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 (AdGVVEGF121.10) 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.



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	 	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.



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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.



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	 	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 object to such proposed
publication or presentation if such materials disclose patentable
subject matter owned by Cordis (including, without limitations,
owned jointly with GenVec) or Confidential Information of Cordis
protected from disclosure under Section 5. If Cordis makes no
objection within such time period, GenVec shall be free to proceed
with such publication or presentation. If Cordis objects, GenVec
shall (i) in the case of an objection regarding the disclosure of
patentable subject matter, refrain from making such publication or
presentation for a reasonable period of time, not to exceed sixty
(60) days, to enable a patent application to be prepared and filed,
or (ii) remove the objectionable material.
	 
	 	C.	 	Subject to Section 13E, Cordis shall not use the trade name
or trademarks of GenVec or the name of any member of the Project
staff in any publicity, advertising or news release without the
prior written approval of an authorized representative of GenVec,
and GenVec shall not use the trade name or trademarks of Cordis or
the name of any employee of Cordis in any publicity without the
prior written approval of Cordis.



Section 7. Ownership and Protection of Intellectual Property




	 	A.	 	GenVec acknowledges that Cordis has certain intellectual
property rights to its medical devices (“Cordis Technology”). As
between the parties, Cordis shall retain all



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	 	 	 	proprietary rights and interest in Cordis’ Technology. GenVec
shall have no rights or interest in Cordis’ Technology other than
the right to use Cordis’ Technology to perform the Project in
accordance with this Agreement.
	 
	 	B.	 	Cordis Acknowledges that GenVec has certain intellectual
property rights related to the Compound, its adenovector technology
and related development, construction, manufacturing, and quality
technologies and methods for using these technologies (“GenVec
Technology”). As between the parties, GenVec shall retain all
proprietary rights and interest in all GenVec Technology. Cordis
shall have no rights or interest in any GenVec Technology other than
the right to use GenVec Technology to perform the Project in
accordance with this Agreement.
	 
	 	C.	 	Inventions conceived, reduced to practice or otherwise
developed in connection with the performance of the Project related
solely to GenVec Technology shall be the property of GenVec.
	 
	 	D.	 	Inventions conceived, reduced to practice or otherwise
developed in connection with the performance of the Project related
solely to Cordis Technology shall be the property of Cordis.
	 
	 	E.	 	Joint Inventions from the Project that are not related solely
to Cordis Technology or GenVec Technology shall be jointly owned by
GenVec and Cordis and each shall have the right to practice, license
and otherwise exploit the same without the consent of or accounting
to the other party. If a party wishes to pursue applying for a
patent on, or similar governmental action to protect, a Joint
Invention, the parties shall seek to agree concerning a strategy for
the protection of the same in countries of interest to the parties.
With respect to any country, if the parties agree to share the
expenses, all costs of obtaining patent or other protection,
including reasonable attorneys fees, shall be shared equally between
the parties, and the parties shall consult and cooperate with
respect to all material actions. If one party does not wish to
pursue patent or other protection on a Joint Invention in any
particular country, it shall inform the other party in writing and
indicate that it does not wish to share in the expenses. Upon
receipt of such writing, the party then pursuing the patent or other
protection at its own expense shall own solely any patent,
registration or the like in that country that issues from that
application and other patents, registrations or the like claiming
priority thereto, including, without limitation, any continuations,
divisionals, or continuations in part. The party not sharing in the
expenses shall have a fully paid up, royalty free, nonexclusive
license in the relevant country to make, have made, use, import,
offer for sale, sell and otherwise practice the relevant Joint
Invention.
	 
	 	F.	 	GenVec Inventions that are not related solely to Cordis
Technology shall be owned by GenVec.
	 
	 	G.	 	Cordis Inventions that are not related solely to GenVec
Technology shall belong to Cordis.
	 
	 	H.	 	The owner of an Invention described in Section 7F or G hereby
grants the other party a fully paid up, royalty free, non-exclusive
license to make, have made, use, import, offer for sale, sell and
otherwise practice the relevant Invention.
	 
	 	I.	 	The licensee under a license granted in Section 7E or H may
grant or authorize sublicenses to its contractors and in connection
with products and services it provides and grants of licenses under
material intellectual property rights it owns, and the licensee may
assign such license in connection with the disposition or
restructuring of that portion of its business to which the license
relates.



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	Section 8.	 	Conflicting Transactions
	 
	 	A. *	 	 
	 
	Section 9.	 	Term and Termination
	 
	 	B.	 	The term of this agreement shall be 3 years beginning on the
Effective Date, or until three months after Final Report is received
by Cordis, whichever comes first. The parties may extend the term
of this Agreement by written agreement.
	 
	 	C.	 	If proper written approval from European governmental
authorities to conduct the Project is not obtained within ninety
days after the date for such approval set forth in Appendix B, and
an alternative strategy cannot mutually be agreed upon, either party
shall have the right to terminate this Agreement, and if it does so,
Cordis shall be entitled to a refund of any amounts already paid to
GenVec, less amounts already spent or committed to being spent on
the Project.
	 
	 	D.	 	If GenVec enters into a Conflicting Transaction, Cordis shall
have the right to terminate this Agreement, and if it does so,
Cordis shall be entitled to a refund of any amounts already paid to
GenVec, less amounts already spent or committed to being spent on
the Project.
	 
	 	E.	 	If proper written approval from U.S. governmental authorities
to conduct the Project is not obtained within ninety days after the
date for such approval set forth in Appendix B, or regulatory
authorities require that the Project be halted, or GenVec elects to
discontinue development of the Compound based on results of the
Project, and an alternative strategy cannot mutually be agreed upon,
GenVec shall have the right to terminate this Agreement, and if it
does so, Cordis shall be entitled to a refund of any amounts already
paid to GenVec, less amounts already spent or committed to being
spent on the Project.
	 
	 	F.	 	Either party may terminate this Agreement upon thirty (30)
days written notice if the Principal Investigator or Co-Principal
Investigators become unable or unwilling to continue performance of
the Project.
	 
	 	G.	 	This Agreement may be terminated, prior to the expiration of
its term, by either party by giving written notice of its intent to
terminate and stating the grounds therefore if the other party shall
materially breach or materially fail in the observance or
performance of any representation, warranty, guarantee, covenant or
obligation under this Agreement. The party receiving the notice
shall have 30 days from the date of receipt thereof to cure the
breach or failure. In the event such breach or failure is cured,
the notice shall be of no effect.
	 
	 	H.	 	This Agreement may be terminated, prior to the expiration of
its term, upon fifteen (15) days written notice by either party: (i)
in the event that the other party hereto shall (1) apply for or
consent to the appointment of, or the taking of possession by, a
receiver, custodian, trustee or liquidator of itself or of all or a
substantial part of its property, (2) make a general assignment for
the benefit of its creditors, (3) commence a voluntary case under
the United States Bankruptcy Code, as now or hereafter in effect
(the “Bankruptcy Code”), (4) file a petition seeking to take
advantage of any law (the “Bankruptcy Laws”) relating to bankruptcy,
insolvency, reorganization, winding-up, or composition or
readjustment of debts, (5) fail to controvert in a timely and
appropriate manner, or acquiesce in writing to, any petition filed
against it in any involuntary case under the Bankruptcy Code, or (6)
take any corporate action for the purpose of effecting any of the
foregoing; or (ii) if a proceeding or case shall be commenced
against the other party hereto in any court of competent
jurisdiction, seeking (1) its liquidation, reorganization,
dissolution or winding-up, or the composition or readjustment of its
debts, (2) the appointment of a trustee, receiver, custodian,
liquidator or the like of the party or of all or any substantial
part of its assets, or (3) similar relief under any Bankruptcy Laws,
or an



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	 	 	 	order, judgment or decree approving any of the foregoing shall be
entered and continue unstayed for a period of 60 days; or an order
for relief against the other party hereto shall be entered in an
involuntary case under the Bankruptcy Code.
	 
	 	I.	 	In the event of termination for whatever reason, the parties
agree to cooperate and take all reasonable steps necessary to
discontinue ongoing activities under this Agreement to protect the
safety and well-being of patients enrolled in ongoing clinical
studies.
	 
	Section 10.	 	Independent Contractor





	 	 	GenVec shall be an independent contractor. The manner in which the
Project is undertaken shall be at the sole control and discretion of
GenVec. Cordis shall not be responsible for the acts of GenVec or its
personnel while performing this Project. Neither GenVec nor Cordis shall
have or hold itself out as having the right or authority to assume or
accept any obligation or responsibility, whether express or implied, on
behalf of the other party.





	Section 11.	 	Insurance
	 
	 	A.	 	Each party warrants and represents that it has a commercially
reasonable level of liability insurance.




	Section 12.	 	Representations, Warranties; Indemnification and Limitation of
Liability.
	 
	 	A.	 	Cordis and GenVec each warrant to the other that:



	 
	 	i.	 	it has the power to execute, deliver and
perform the terms and conditions of this Agreement and has
taken all necessary actions to authorize the execution,
delivery and performance hereof;
	 
	 	ii.	 	the execution, delivery or performance of this
Agreement will not contravene any provision of any law,
statute, rule, regulation or policy, whether oral or written,
of any local, state or federal authority or of either party;
	 
	 	iii.	 	the execution, delivery or performance of this
Agreement will not constitute a violation of, be in conflict
with, or result in a breach of, any agreement or contract to
which it is a party;
	 
	 	iv.	 	it will adhere to all federal, state or local
requirements applicable to its performance hereunder; and
	 
	 	v.	 	it will use commercially reasonable efforts to
maintain an adequate supply of qualified personnel to ensure
the timely completion of its obligations hereunder.


	 
	 	B.	 	Cordis and GenVec agree to defend, indemnify and hold
harmless the other party from and against any and all third party
claims and demands, and resulting losses, liability, expenses, or
damages such other party may suffer, pay or incur as a result of the
indemnifying party’s breach of any of its warranties set forth in
this Agreement.
	 
	 	C.	 	IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY PUNITIVE,
EXEMPLARY, MULTIPLIED, INDIRECT, INCIDENTAL, SPECIAL OR
CONSEQUENTIAL DAMAGES, ATTORNEYS’ FEES OR COSTS, AND EACH PARTY
HEREBY IRREVOCABLY WAIVES ANY RIGHT TO SEEK THE FOREGOING.



Section 13. Miscellaneous



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	 	A.	 	Governing Law. This Agreement shall be governed and
construed in accordance with the laws of the State of New York.
	 
	 	B.	 	Assignment. This Agreement shall not be assigned by either
party without the prior written consent of the other party hereto,
which shall not be withheld or delayed unreasonably, except that
either party may assign this agreement to one of its affiliated
companies or to the purchaser of all or substantially all of its
assets relating to this Agreement or in connection with a merger,
disposition or other restructuring of its business relating to this
Agreement.
	 
	 	C.	 	Agreement Modification. Any change to this Agreement shall
be valid only if the change is made in writing and signed by
authorized representatives of the parties hereto.
	 
	 	D.	 	Dispute Resolution. Any controversy or claim arising out of
or relating to this Agreement or the validity, inducement, or breach
thereof, shall be settled by arbitration before a single arbitrator
in accordance with the Commercial Arbitration Rules of the American
Arbitration Association (“AAA”) then pertaining, except where those
rules conflict with this provision, in which case this provision
controls. The parties hereby consent to the jurisdiction of the
federal district court for the district in which the arbitration is
held for the enforcement of this provision and the entry of judgment
on any award rendered hereunder. Should such court for any reason
lack jurisdiction, any court with jurisdiction shall enforce this
clause and enter judgment on any award. The arbitration shall be
held in Washington, D.C., and in rendering the award the arbitrator
must apply the substantive law of New York (except where that law
conflicts with this clause), except that the interpretation and
enforcement of this arbitration provision shall be governed by the
Federal Arbitration Act. The arbitrator shall be neutral,
independent, disinterested, impartial and shall abide by The Code of
Ethics for Arbitrators in Commercial Disputes approved by the AAA.
Within 45 days of initiation of arbitration, the parties shall reach
agreement upon and thereafter follow procedures assuring that the
arbitration will be concluded and the award rendered within no more
than eight months from selection of the arbitrator. Failing such
agreement, the AAA will design and the parties will follow
procedures that meet such a time schedule. Each party has the right
before or, if the arbitrator cannot hear the matter within an
acceptable period, during the arbitration to seek and obtain from
the appropriate court provisional remedies such as attachment,
preliminary injunction, replevin, etc., to avoid irreparable harm,
maintain the status quo or preserve the subject matter of the
arbitration.
	 
	 	E.	 	Public Disclosure. Either party may issue a press release
disclosing the collaboration after written approval is obtained from
the other party, such approval not to be unreasonably withheld or
delayed. Each party has the right to preview all such planned press
releases. Neither party is obligated to agree to any specific
financial terms being disclosed.
	 
	 	F.	 	No waiver of any default in the performance of any of the
duties or obligations arising out of this Agreement shall be valid
unless in writing and signed by the waiving party.
	 
	 	G.	 	The provisions of Sections 5, 6, 7, 9, 12, 13A, 13D, 13F, 13G
and 13H shall survive expiration or termination of this Agreement.
	 
	 	H.	 	All communications hereunder shall be deemed made if given by
facsimile, by registered or certified mail, postage prepaid and
addressed to the party to receive such communication at the address
given below, or such other address as may hereafter be designated by
notice in writing:




	 	 	If to Cordis:       Cordis Corporation



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	14201 NW 60th Avenue
	Miami Lakes, FL 33014
	Attention: New Business Development



                          For Technical Communications:




	 	 	 
	*	 	
Telephone: *
	 	 	
Facsimile: *




	 	 	 
	If to GenVec:	 	
GenVec, Inc.
	 	 	
65 West Watkins Mill Road
	 	 	
Gaithersburg, MD 20878
	 	 	
Attention: Corporate Development



[End of Text; Signatures on Following Page]



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     IN WITNESS WHEREOF, the parties have caused this Agreement to be executed
in duplicate as of the day and year first above written.



	 	 	 	 	 
	 	 	Cordis Corporation
	 	 	 	 	 
	 	 	
By:	 	 
	 	 	 	 	

	 	 	 	 	 
	 	 	
Title:	 	 
	 	 	 	 	

	 	 	 	 	 
	 	 	GenVec, Inc.
	 	 	 	 	 
	 	 	By: E. Michael Egan
	 	 	 	 	 
	 	 	Title: Senior VP Commercial Development



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Appendix A



     Clinical Protocol Outline



	 	 	 
	Investigational

Drug:	 	
BIOBYPASS as previously defined in Section 1A as the Compound.
	 	 	 
	Device Name:	 	
Cordis-Webster NOGA/MYOSTARTM Transendocardial Injection
SystemTM as previously defined in Section 1F as the Device.
	 	 	 
	Title Of Study:	 	
A Multicenter, Randomized, Double-Blind, Placebo-Controlled
Study Evaluating Efficacy of NOGA-Guided/ Myostar Catheter
Delivery of BIOBYPASS (AdGVVEGF121.10) In “No Option”
Patients With Class III-IV Stable Angina
	 	 	 
	Trial Phase:	 	
Phase II
	 	 	 
	Enrollment:	 	
A total of 125 patients randomized to BIOBYPASS
(AdGVVEGF121.10) treatment (single dose) or placebo
treatment in a * randomization.
	 	 	 
	Clinical Site

Locations:	 	
Up to * Clinical Centers Located in Europe
	 	 	 
	Study Population:	 	
Inclusion criteria
	 	 	 
	 	 	
Subjects with documented coronary artery disease experiencing

chronic, refractory coronary ischemia with:
	 
	 	 	
   1.   *
	 	 	
   2.   *
	 	 	
   3.   *
	 	 	
   4.   *
	 	 	
   5.   *
	 	 	
   6.   *
	 	 	
   7.   *
	 	 	
   8.   *
	 	 	 
	 	 	
Exclusion criteria
	 	 	 
	 	 	
   1.   *
	 	 	
   2.   *
	 	 	
   3.   *
	 	 	
   4.   *
	 	 	
   5.   *
	 	 	
   6.   *
	 	 	
   7.   *
	Purpose:	 	
To * BIOBYPASS (AdGVVEGF121.10) delivered using Biosense
NOGA/MYOSTARTM transendocardial injection system on * in
patients with chronic refractory coronary ischemia.
	 	 	 
	Structure:	 	
Multi-center, randomized, prospective comparison of treatment
and placebo control group(s) with blinded patient and *
evaluation. *



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	Screening	 	
All patients shall receive oral and written information, and
sign a written informed consent.
	 	 	 
	 	 	
*
	 	 	 
	 	 	
   1.   *
	 	 	
   2.   *
	 	 	
   3.    *
	 	 	
   4.   *
	 	 	
   5.   *
	 	 	
   6.   *
	 	 	
   7.   *
	 	 	
   8.   *
	 	 	
   9.   *
	 
	 	 	
*
	 
	 	 	
   1.   *
	 	 	
   2.   *
	 	 	 
	Randomization	 	
The patient is *.

The patient is *.

The patient is *.

	 	 	 
	*	 	* 
	 	 	 
	Sponsor(S):	 	
GenVec, Inc.;
	 	 	 
	Principal	 	 
	Investigator:	 	
*
	 	 	 
	Steering

Committee:	 	
*
	 	 	 
	*	 	
*



13







 



Appendix B



Project Milestones

*






14