EXHIBIT 10.11
THIS ("Agreement" or "") dated as of April 1, 1998 (the "Effective Date") is entered into by
and between GENVEC, INC., a Delaware corporation ("Sponsor"), and CORNELL
UNIVERSITY, a not-for-profit educational institution having corporate powers
under the laws of the State of New York ("University"), for its Medical College
("Medical College").
WITNESSETH:
WHEREAS, the Sponsor and the University have previously entered into
that certain effective as of May 18, 1993 (the
"Prior "), pursuant to which Sponsor supported
preclinical research and clinical research at the Medical College in connection
with Gene Therapy (as defined in Appendix 1 hereto), which relationship the
parties wish to extend;
WHEREAS, the Gene Therapy research project that is to be conducted at
the Medical College with the support of the Sponsor is to be jointly supervised
by Xxxxxx X. Xxxxxxx, M.D. ("Dr. Crystal"), a Professor of Medicine at the
Medical College and a paid consultant and equity holder of the Sponsor and
Chairman of the Sponsor's Scientific Advisory Board, and by the Medical
College's Chairman of the Department of Medicine (currently Xxxxx X. Xxxxxxx,
M.D. ("Xx. Xxxxxxx")), all as permitted by and in accordance with applicable
Laws and University Policies (as defined in Appendix 1 hereto);
WHEREAS, the Sponsor has entered into an Amended and Restated
Exclusive License Agreement in the form attached as Exhibit A hereto ("License
Agreement") with the Cornell Research Foundation, Inc. ("Foundation"), a wholly
owned subsidiary of the University;
WHEREAS, the Gene Therapy discoveries and inventions made during the
course of the Sponsored Research (as defined in Appendix 1 hereto), as
contemplated by this Agreement, are of mutual interest and benefit to the
University and to the Sponsor, will further instructional and research
objectives of the University in a manner consistent with its status as a
not-for-profit tax-exempt educational institution, and may constitute benefits
for both the Sponsor and the University (including, without limitation, the
Medical College) through inventions, improvements, and discoveries;
NOW THEREFORE, in consideration of the premises and mutual covenants
herein contained, the parties hereto agree to the following:
1. DEFINITIONS
Capitalized terms used in this Agreement and set forth in Appendix 1 hereto
shall have the meanings set forth in such Appendix 1.
2. SCOPE AND PERFORMANCE OF WORK
[*]=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.
The University shall commence the performance of the Sponsored Research on
the Effective Date, and, concurrently with compliance by Sponsor with all terms
(including payment terms) of this Agreement, agrees to use reasonable efforts to
perform the Sponsored Research in accordance with the terms and conditions of
this Agreement.
3. PRINCIPAL INVESTIGATORS
3.1 SUPERVISION OF THE SPONSORED RESEARCH
As described in the Crystal Appointment Letter, Dr. Crystal and the
Chairman shall jointly supervise the Sponsored Research. Initial (including
"Phase I", and/or "Phase I/II", if approved by the Medical College) human
feasibility trials with respect to the Sponsored Research may take place at the
University (including the Medical College), at affiliated hospitals, clinics, or
other institutions affiliated with the Medical College, under the direction of
the Principal Investigators. Any Phase II and Phase III trials will take place
entirely under the supervision of independent investigators who are not and have
not been associated with the Sponsored Research. The parties hereto acknowledge
and agree that the Crystal Appointment Letter has been approved by the Medical
College, the University, The New York Hospital, and all applicable internal
review boards of such bodies, including, without limitation, those charged with
responsibility for administration of the University's conflict of interest
policies, as of the date of this Agreement, subject, however, to any changes in
such approvals and policies as the University or such other entities or boards
may determine to be necessary or advisable.
3.2 CHANGE IN PRINCIPAL INVESTIGATORS
In the event that Dr. Crystal dies, becomes disabled such that he
cannot continue his employment at the Medical College, terminates his employment
at the Medical College, or his employment at the Medical College is otherwise
terminated, either party to this Agreement shall have the option to terminate
this Agreement and the Sponsored Research in the manner provided in Section 8.
If Xx. Xxxxxxx dies, becomes disabled such that he cannot continue his
employment at the Medical College, terminates his employment at the Medical
College, or his employment at the Medical College is otherwise terminated, or
otherwise is unable or unwilling to continue to serve as co-Principal
Investigator with respect to the Sponsored Research, the successor to Xx.
Xxxxxxx as Chairman shall serve as co-Principal Investigator with Dr. Crystal,
unless the University shall have designated another member of its faculty
reasonably acceptable to Sponsor and to Dr. Crystal to serve as the co-Principal
Investigator with Dr. Crystal; provided, however, that if such Chairman or other
faculty member has any consulting or other commercial relationship with a
competitor of Sponsor in the gene therapy field, the University, upon notice of
objection from Sponsor, shall designate another member of its faculty,
reasonably acceptable to Sponsor and Dr. Crystal, without such relationship, to
serve as co-Principal Investigator.
4. PERIOD OF PERFORMANCE
The period of performance under this Agreement will terminate on April
1, 2002, unless earlier terminated pursuant to this Agreement or extended by
written agreement of the parties.
-2-
5. PAYMENTS
5.1 SPONSOR PAYMENTS
The Sponsor agrees to make payments to the University (on behalf of
the Medical College) for certain costs of the Sponsored Research in accordance
with the payment schedule attached as Exhibit B hereto ("Sponsor Payments"),
subject to and in accordance with the terms of this Agreement. Sponsor Payments
shall be used over the term of this Agreement for the rental of space for Dr.
Crystal's laboratory, the purchase or rental of the substantial portion of the
equipment in such laboratory, a portion of Dr. Crystal's salary from the
University, general research support for preclinical feasibility projects and
clinical evaluation of Gene Therapy technology (excluding Phase II and Phase III
studies), and related matters, including support of other members of Dr.
Crystal's laboratory (all of whom will be employees of the University). The
aggregate amount of the Sponsor Payments shall be Five Million Seven Hundred
Thousand Dollars ($5,700,000), unless the parties agree otherwise pursuant to
Section 5.2. All checks (or electronic funds transfers) shall be made payable to
Cornell University Medical College and sent to the address specified in Section
19.6. Within ninety (90) days after termination of this Agreement, the
University shall submit a final financial report setting forth costs incurred.
The report shall be accompanied by a check in the amount, if any, of the excess
of Sponsor Payments received by the University over costs actually incurred by
or on behalf of the University in connection with the Sponsored Research.
5.2 ADDITIONAL PAYMENTS
It is agreed to and understood by the parties that the aggregate
amount of the Sponsor Payments is an estimate of the cost of the Sponsored
Research, but that the Sponsor shall not be liable for any payments or costs in
excess of the Sponsor Payments unless the Sponsor shall have previously agreed
in writing to provide additional funds. Funding for work to be performed during
a period beyond that set forth in Section 4, or for work in addition to the
Sponsored Research, shall be agreed to by the Sponsor and the University in
writing prior to the initiation of any such work.
5.3 UNIVERSITY BOOKS AND RECORDS
The University shall maintain records and books of account relating to
this Agreement in accordance with its normal course of business, University
Policies, and prevailing University accounting practices, and shall make such
records and books available to Sponsor upon reasonable notice during normal
business hours, but not more frequently than once every four (4) months.
The University shall maintain scientific records that will properly
reflect all work done, and data and results achieved in the performance of the
Sponsored Research (including all data in the form required under any applicable
governmental regulations) in a manner sufficient to establish the dates of first
conception and reduction to practice of any inventions.
-3-
5.4 SPONSOR PAYMENTS
Any funds paid to the University pursuant to the Prior which were not expended as of the Effective Date hereof shall
be used to support the Sponsored Research subject to this Agreement. Such funds
shall be additional to the payments due pursuant to Section 5.1, but otherwise
shall be treated as Sponsor Payments for all purposes of this Agreement.
5.5 OTHER FUNDS
The University shall not use funds from any commercial third party to
support any aspect of the Sponsored Research without the prior written consent
of Sponsor.
6. INVENTIONS AND PATENTS
The Medical College shall disclose all Sponsored Research Intellectual
Property Rights to the Sponsor as promptly as practicable upon receipt of such
disclosure, but in no event later than * after the inventor discloses it in
writing to the Medical College personnel responsible for patent matters. The
Principal Investigators shall ensure that all such Sponsored Research
Intellectual Property Rights are promptly disclosed to the Medical College in
writing. The disclosure to the Sponsor shall be in the form of a written report
and shall identify the inventor(s) and this Agreement as being that under which
such invention was made. Such report shall be sufficiently complete in technical
detail to convey a clear understanding, to the extent known at the time of the
disclosure, of the nature, purpose, operation, and the physical, chemical,
biological, or electrical characteristic of the invention. To afford the parties
a reasonable opportunity to preserve their intellectual property rights, without
the parties' written consent neither the Medical College nor the Sponsor shall
disclose such Sponsored Research Intellectual Property Rights to third parties
for at least * days after the date of such disclosure to the Sponsor pursuant to
this Section 6; provided that during such * day period and thereafter the
Sponsor may disclose such Sponsored Research Intellectual Property Rights to a
corporate partner of Sponsor which is entitled to a sublicense of all or part of
the Sponsored Research Intellectual Property Rights, if such corporate partner
and Sponsor have a written agreement of confidentiality consistent with the
provisions hereof. Any disclosures made pursuant to this Section 6 shall also
comply with Section 10 hereof with respect to any proposed publication, sale, or
public use of the invention and shall disclose whether a manuscript describing
the invention has been prepared and is proposed to be submitted for publication
or presentation. Title to reported inventions will be held in accordance with
Section 16.1. Within * of receipt of the invention report, the Sponsor may
notify the University, in writing, that it elects to license such reported
invention to the extent permitted by, and in accordance with the terms of, the
License Agreement. Notwithstanding this Section 6 or any other provision of this
Agreement, however, except to the extent the same are included within Sponsored
Research Intellectual Property Rights, the parties agree that this Agreement
does not authorize or compel the disclosure to the Sponsor of information
regarding research designs, methods, proposals, findings, or similar information
or data of investigators (or other University employees) not employed in Dr.
Crystal's laboratory and under the joint supervision of Dr. Crystal and the
Chairman (even though the Sponsor's funds may have been used to provide
ancillary noninventive services or equipment to such inventor or other
employee).
-4-
7. PROPRIETARY INFORMATION
The Medical College's acceptance and use of any proprietary
information or proprietary biological materials that may be supplied by the
Sponsor in the course of this research project shall be subject to the
following:
(i) The Sponsor shall xxxx or designate in writing the information or
biological materials as being proprietary to the Sponsor or, where appropriate,
to a sublicensee of Sponsor.
(ii) The Medical College retains the right to refuse to accept any
such information or biological materials that it does not consider to be
essential to the completion of the Sponsored Research or that it believes to be
improperly designated, for any reason.
(iii) Where the Medical College does accept such information, it
agrees to use reasonable efforts not to publish or otherwise reveal the
information to others outside the Medical College without the permission of the
Sponsor, unless the information has already been published or disclosed, or the
information has already been independently developed, in each case by third
parties or is or are required to be disclosed or delivered by order of a court
of law or regulatory agency.
(iv) Where the Medical College does accept such biological materials,
their use shall be subject to the terms of the Material Transfer Agreement
entered by Sponsor and the Medical College effective December 19, 1996 (the
"Material Transfer Agreement"), a copy of which is attached hereto as Exhibit C.
8. TERMINATION
8.1 TERMINATION EVENTS
This Agreement may be terminated (prior to the expiration of its term
pursuant to Section 4) at any time by one party, upon written notice to the
other party, upon the occurrence of any of the following events:
(i) either party may terminate the Agreement if Dr. Crystal dies,
becomes disabled such that he cannot continue his employment at the Medical
College, terminates his employment at the Medical College, or his employment at
the Medical College is otherwise terminated;
(ii) either party may terminate the Agreement if, in the reasonable
judgment of the terminating party, termination is necessitated by reason of a
change in Laws; provided, however, that the Sponsor shall not use as a ground of
termination such a change which could be cured by a revision of Dr. Crystal's
relationship with the Sponsor;
(iii) a party may terminate the Agreement if it has a reasonable basis
to believe that the other party has engaged in unlawful, unethical, or seriously
inappropriate conduct such that continued performance of the Agreement would
affront legitimate interests of the terminating party; or
-5-
(iv) a party may terminate the Agreement if the other party has
committed a material breach of the terms of this Agreement or the License
Agreement and has failed to remedy such breach within ten (10) days in relation
to a payment-related breach, and thirty (30) days in relation to other breaches,
following written notice thereof. For purposes of this Section 8, a failure by
the Sponsor to make any payment required pursuant to Section 5 shall be deemed a
material breach.
(v) In the event that a party intends to terminate the Agreement under
Section 8.1(ii), (iii) or (iv), the party shall give written notice to that
effect to the other party, which notice shall effect forthwith suspension of
future performance of the Agreement. The party so notified may initiate
arbitration under Section 19.5, by filing a request for arbitration with the
American Arbitration Association, not later than ten (10) days thereafter, and
termination shall occur if (a) arbitration is not so initiated, or (b) the
arbitrator finds that termination was reasonable.
(vi) Sponsor may provide notice of termination any time for any reason
after October 1, 1999, and in any such case, such termination will be effective
twelve (12) months thereafter.
8.2 TERMINATION CONSEQUENCES
In the event of early termination of this Agreement by the Sponsor
pursuant to Section 8.1, or by the University pursuant to Section 8.1(ii),
(iii), or (iv), the Sponsor shall remit to the University funds in payment of
(a) all internal and external costs and non-cancelable obligations, including
future costs and obligations, incurred as of the date of termination by the
University incident to the Sponsored Research (including, without limitation,
rent, personnel costs, facilities costs, and other costs) until such time as the
University, exercising its best efforts, shall eliminate such costs (or utilize
such personnel and facilities in other endeavors), and (b) any other amounts
that have accrued under this Agreement as of the date of such termination. With
respect to all payments by the Sponsor required by this Section 8.2, in no event
shall the liability of the Sponsor for Sponsor Payments in connection with the
Sponsored Research exceed One Million Four Hundred Twenty-Five Thousand Dollars
($1,425,000) or such other amount as the parties hereto have agreed upon
pursuant to Section 5. Any and all Sponsored Research Intellectual Property
Rights conceived or reduced to practice or otherwise developed prior to the
effective date of such termination shall remain subject to the terms of the
License Agreement, which shall remain in effect until and unless terminated
under its terms.
9. PUBLICITY
The parties acknowledge their mutual intention to announce major
scientific discoveries to the public on a prompt and cooperative basis,
consistent with the terms of this Section 9 and other provisions of this
Agreement. The parties agree that neither the University nor any employee
thereof shall in any way promote, or participate or be used or referred to in
connection with the promotion of the Sponsor or any of Sponsor's products,
securities, or marketing efforts, and that neither party shall use the existence
or terms of this Agreement, any results of the Sponsored Research, or the name
of the other party (or any employee or affiliate thereof) in any public
disclosure, advertising, news release, or other statement that is or may become
public or available to a third party, in each case except as and to the extent
(i) required by Laws (including Securities Laws), (ii) permitted by Section 10,
(iii) permitted
-6-
by Section 6, or (iv) with the prior written consent of, and only to the extent
approved by, the other party (which consent shall, in the case of the
University, be signed by the Xxxx of the Medical College and by University
counsel). Notwithstanding the above, once a particular disclosure has been
approved, either party may make disclosures which do not differ materially
therefrom without any further consents of the other party; provided, however,
that the disclosing party shall give prior notice of subsequent disclosures
which, in addition to the information contained in the earlier disclosure,
contains information subject to this Agreement which has not been previously
disclosed; and provided, further, that after approval of a disclosure has been
given, the approving party may at any time with written notice to the other
party withdraw its approval of a particular disclosure prior to its release,
which withdrawal shall be effective immediately. With respect to the
requirements of Securities Laws, counsel to the underwriters or placement agents
of Sponsor's securities may advise Sponsor that Sponsor may be required to
disclose material terms of this Agreement and the License Agreement. In such
event, Sponsor shall so notify the University within a reasonable time prior to
such disclosure, and the University shall have the opportunity to dissuade such
counsel of the need for such disclosure. With respect to any such prospective
disclosure, Sponsor shall use its reasonable efforts, unless the University
otherwise consents, not to use the name of the University, and to seek
"Confidential Treatment" under applicable Securities and Exchange Commission
rules and procedures with respect to any terms of this Agreement and the License
Agreement for which the University wishes to obtain confidential treatment.
Laboratory personnel, including Dr. Crystal, will not engage in solicitation of
the sale of securities of Sponsor, but may, to the extent that doing so does
not, in the University's judgment, unreasonably interfere with their work,
participate in connection with the due diligence investigations of potential
investors and underwriters of securities of Sponsor in describing the Gene
Therapy research and may, to the same extent, respond to questions from such
persons.
10. PUBLICATIONS
10.1 RIGHT TO PUBLISH; PROCEDURES
The University shall have the right, subject to compliance with the
provisions of this Agreement, at its discretion to release information or to
publish any material resulting from the Sponsored Research, and the Sponsor
agrees that the Principal Investigators and other researchers engaged in the
Sponsored Research shall be permitted to present at national, regional and other
professional meetings and symposia, and to publish in journals, theses or
dissertations, or other materials of their own choosing, the progress and
results of the Sponsored Research. The University agrees to furnish the Sponsor
with a copy of any proposed written publication at least * in advance of the
submission of such proposed publication or other written description of research
results to a journal, editor or other third party, in order for the Sponsor to
have an opportunity to begin to seek appropriate legal protection for the
subject matter contained in the proposed publication or description. If due to a
valid business reason or a reasonable belief by the non-disclosing Party that a
disclosure relating to the Sponsored Research contains subject matter for which
a patent should be sought, then prior to the expiration of the * the non-
disclosing party shall so notify the disclosing party, who shall then delay
public disclosure of the information for an additional period of up to * to
permit the preparation of filing of a patent application on the subject matter
to be disclosed or other action to be taken. The Sponsor shall cooperate with
the University and the Foundation, at their request, in the patenting process.
-7-
10.2 ACKNOWLEDGMENT OF THE SPONSOR
The Sponsor will be given full credit and acknowledgment for the
support provided to the University in any publication resulting from the
Sponsored Research, to the extent Sponsor consents to such credit or
acknowledgment, or such publication requires the same, or the University desires
to list Sponsor in any reports of University's sponsored research projects.
11. REPORTS AND CONFERENCES
11.1 PROGRESS AND FINAL REPORTS TO THE SPONSOR
The University shall furnish the Sponsor letter reports during the
term of this Agreement summarizing the work conducted with respect to the
Sponsored Research, no more frequently than once every four (4) months. A final
written report setting forth and detailing the accomplishments and significant
findings shall be submitted by the University within * of the termination of
this Agreement.
11.2 MEETINGS BETWEEN THE UNIVERSITY AND THE SPONSOR
During the term of this Agreement, representatives of the University
will meet with representatives of the Sponsor at times and places mutually
agreed upon to discuss the progress and results, as well as ongoing plans, or
changes therein, of the Sponsored Research to be performed hereunder. The
Sponsor shall reimburse the University for all reasonable out-of-pocket expenses
incurred by the University and University employees in connection with any such
meetings that are held at locations other than the Medical College.
12. CHANGES
Anything in this Agreement to the contrary notwithstanding, Sponsor
and the Medical College may at any time amend or extend the Sponsored Research
by mutual written agreement (which, in the case of the Medical College, shall be
signed by the Xxxx of the Medical College), and incorporate such amendment as an
attachment and exhibit to this Agreement. Such changes may include, but are not
limited to, (i) revising (including, without limitation, additions to or
deletions from) the work included in the Sponsored Research, (ii) revising the
period or schedule of performance under Section 4 or as set forth in Exhibit B,
or (iii) increasing or decreasing the Sponsor Payments. Upon any such change,
the parties shall immediately use their best efforts to take all necessary steps
to comply therewith.
13. SPONSOR MATERIALS
Upon the request of the Medical College, the Sponsor agrees to accept
the return of unused portions of any drugs, chemicals, and other materials
supplied by the Sponsor in connection with the Sponsored Research or Biological
Materials provided pursuant to the Material Transfer Agreement ("Sponsor
Materials"), including the containers in which the Sponsor Materials are
shipped, provided that the Sponsor Materials and containers are properly
labeled. The Sponsor agrees to furnish the
-8-
Medical College with sufficient information regarding all such Sponsor Materials
to permit reasonable interpretation of the results obtained in the Sponsored
Research and to identify precautions needed to help protect the health and
safety of personnel using the Sponsor Materials. The Sponsor agrees to indemnify
and defend the University (including, without limitation, the Medical College),
affiliated hospitals, clinics, and other institutions affiliated with the
Medical College, and the officers, trustees, agents, and employees of each of
them, and hold them harmless from any and all injury, illness, death, property
damage, claim, lawsuit, judgment thereon, or cause of action that results either
in whole or in part from the use of the Sponsor Materials (each a "Claim"), not
arising from the indemnified party's gross negligence or willful misconduct, if
such use was pursuant to Sponsor's directions or was reasonable under the
circumstances. The University shall promptly notify Sponsor of any such Claim
for which the University intends to claim indemnification, and cooperate fully
with Sponsor and its attorneys in the investigation, conduct, defense and
settlement of any such Claim.
14. INDEMNIFICATION
The Sponsor agrees to indemnify and defend the University (including
the Medical College), and affiliated hospitals, clinics, or other institutions
affiliated with the Medical College, and the officers, trustees, agents, and
employees of each of them, and hold them harmless from any and all costs,
expenses, and damages, not arising from the indemnified party's gross negligence
or willful misconduct, arising out of any injury, illness, death, property
damage, claim, lawsuit, judgment thereon, or cause of action (each, a "Claim")
to the extent that these result either in whole or in part from action or
inaction on the part of, or on behalf of, the Sponsor in connection with the
conduct of the Sponsored Research. The University shall promptly notify Sponsor
of any such Claim for which the University intends to claim indemnification, and
cooperate fully with Sponsor and its attorneys in the investigation, conduct,
defense and settlement of any such Claim.
15. INSURANCE
Within thirty (30) days after the date of this Agreement, the Sponsor
shall provide to the University evidence that the Sponsor has liability
insurance of at least five million dollars ($5,000,000). Such evidence shall be
in the form of a certificate of insurance or, in the case of self-insurance, a
letter accompanying the Sponsor's audited financial statements in which an
authorized official of the Sponsor certifies that the Sponsor has sufficient
assets to cover potential costs and losses that might arise in connection with
the Sponsor's obligations hereunder.
16. TITLE TO EQUIPMENT, RESEARCH DATA AND INTELLECTUAL PROPERTY RIGHTS
16.1 PROPERTY OF THE UNIVERSITY
Title to all (a) equipment, laboratory animals, and other materials
or property purchased or manufactured in the performance of the Sponsored
Research (collectively, "Research Equipment") funded under this Agreement and
research data (including, without limitation, data contained in any publication
made pursuant to Section 10 hereof and resulting from the Sponsored Research)
shall vest
-9-
in the University and shall remain the property of the University in a manner
consistent with University Policies and customs with respect thereto, and (b)
any intellectual property first conceived or discovered in the performance of
the Sponsored Research shall vest in accordance with the then-prevailing United
States laws of inventorship. The Sponsor shall have the right to receive and
use, subject to the applicable terms of the License Agreement, breeding pairs of
animals and other biological materials developed in connection with the
Sponsored Research and copies of any research data relating to the Sponsored
Research on reasonable request and notice, and upon reimbursement by the Sponsor
of the University's reasonable costs incurred in connection with copying and
providing such research data, animals and other biological materials to the
Sponsor. Copyright to materials, including computer software, first created
during the performance of the Sponsored Research work funded under this
Agreement shall vest in accordance with the University's copyright policy, and
the Sponsor shall have no rights thereto, except to the extent provided in the
License Agreement.
16.2 GOVERNMENT RIGHTS
An agency of the U.S. Government may have certain rights in an
invention first conceived or discovered during the performance of the Sponsored
Research work funded under this Agreement. The University will use reasonable
efforts to perfect its ownership in any invention made with funds provided by
any government agency and to comply with applicable law in maintaining such
rights and to make available to the Sponsor any rights in such invention.
17. ACKNOWLEDGMENT AND UNDERTAKING RESPECTING DR. CRYSTAL
Sponsor hereby acknowledges that it has been informed of the terms
and conditions of the employment of Dr. Crystal at the Medical College, as set
forth in the Crystal Appointment Letter (including, without limitation,
paragraphs 1A-N and the other provisions of Appendix A thereto), and Sponsor
agrees that it will use reasonable care such that nothing requested by Sponsor
of Dr. Crystal will violate any of the duties or obligations of Dr. Crystal to
the University. Nothing in this Agreement or in the License Agreement, or in any
agreement, undertaking, or understanding to which the Sponsor is party, shall
impair the rights of the University or the Principal Investigators to determine
the nature of performance of Sponsored Research, or Dr. Crystal's other research
at the University, in a manner consistent with University Policies. The
University undertakes to notify Sponsor of any changes in the terms and
conditions of Dr. Crystal's employment material to Sponsor, in the University's
reasonable judgment.
18. ENFORCEMENT OF UNIVERSITY RULES AND THIS AGREEMENT
The University shall use its best efforts to enforce observance by
all University personnel engaged in the Sponsored Research with respect to
University Policies. The Sponsor shall cooperate with University in complying
with University Policies and applicable Laws. The University shall use
reasonable efforts to enforce observance, by all University personnel engaged in
the Sponsored Research, of this Agreement.
-10-
19. OTHER PROVISIONS
19.1 CONTINUED APPLICABILITY OF CRYSTAL APPOINTMENT LETTER
Nothing in this Agreement shall be deemed to modify or supersede the
Crystal Appointment Letter (including, without limitation, paragraphs 1A-N and
the other provisions of Appendix A thereto) all of which the parties
acknowledge.
19.2 NO CONFLICTS
The Sponsor represents and covenants that there are no obligations,
undertakings, representations, warranties, covenants, conditions, rights,
recitals or other statements by or applicable to the University, Dr. Crystal, or
the Sponsored Research (collectively, "Terms") contained in any of its
arrangements, understandings or agreements with Dr. Crystal (collectively, the
"Other Arrangements") that Conflict with any Terms of this Agreement. For
purposes of this Agreement, the word "Conflict" shall include, without
limitation, any case in which (1) performance of a Term in one agreement would
result in a breach or violation of any present or future agreement or
obligation, written or oral, in connection with a Term in another agreement, and
(2) a Term in one agreement could not be carried out as a legal and/or practical
matter consistently with a Term of another agreement absent an amendment to,
waiver of, or potential liability under, such other agreement. The Sponsor
covenants and agrees that it will not knowingly cause or permit any Conflict to
exist between a Term of this Agreement, on the one hand, and a Term of any Other
Agreement, on the other hand, and that, insofar as any Conflict exists at any
time, the Sponsor will seek to cause such Conflicting Term in the Other
Agreement to be waived, amended or rendered null and void, to the extent
necessary to remedy the Conflict.
19.3 NO AGENCY
Neither party is authorized or empowered to act as an agent for the
other for any purpose. Neither party shall, on behalf of the other, enter into
any contract, warranty, or representation as to any matter. Neither party shall
be bound by the acts or conduct of the other.
19.4 FORCE MAJEURE
Neither the University nor the Sponsor shall be liable for any
failure to perform as required by this Agreement, to the extent such failure to
perform is caused by any reason beyond the control of the University or the
Sponsor, as applicable, or by reason of any of the following occurrences, labor
disturbances or labor disputes of any kind, accidents, failure of any
governmental approval required for full performance, civil disorders or
commotions, acts of aggression, floods, earthquakes, acts of God, energy or
other conservation measures, explosion, failure of utilities, mechanical
breakdowns, material shortages, disease or other such occurrences (collectively,
"Force Majeure Conditions"); provided, however, that nothing in this Section
19.4 shall excuse any delay or failure on the part of the Sponsor to make the
Sponsor Payments on a timely basis pursuant to the terms of this Agreement. In
the event of any delayed or excused performance pursuant to this Section 19.4,
the party or parties whose performance was delayed or excused shall use
reasonable efforts to perform as promptly and fully as
-11-
practicable, and the parties shall take all other reasonable and cooperative
steps to effectuate the transactions contemplated by this Agreement. If one or
more Force Majeure Conditions cause the University to be unable to conduct
Sponsored Research for at least two consecutive weeks, the obligation of Sponsor
to make Sponsor Payments shall be diminished by * for each such week. In the
event that there are more than * weeks, either party may elect to terminate the
Agreement under the provisions of Section 8.1(iv), as if such circumstance were
a material breach thereunder and as if the University were the terminating party
thereunder.
19.5 ARBITRATION
Any dispute arising out of or relating to this Agreement or any
breach of this Agreement, including, without limitation, any disagreement by the
terminated party with respect to termination of this Agreement pursuant to
Sections 8.1(ii), (iii) or (iv) shall be submitted to and determined in binding
arbitration, which shall be conducted in accordance with the then-current rules
and procedures of the American Arbitration Association, subject to the
provisions of this Section 19.5. The arbitration shall be conducted before and
by a single neutral arbitrator with relevant expertise selected by the parties.
If the parties have not selected an arbitrator within * after delivery to the
other party of one party's written demand for arbitration, the arbitrator shall
be selected by the American Arbitration Association pursuant to then-current
rules of that Association. The arbitrator shall have authority to fashion such
just, equitable and legal relief as he, in his sole discretion, may determine,
including, without limitation, specific performance, injunctive or other
equitable relief. Each party shall bear all its own expenses of arbitration and
shall equally share the costs (i.e., arbitrators fees and administrative
charges) of conducting the arbitration. All arbitration proceedings shall be
conducted in New York, New York. The parties shall abide by the terms of any
arbitration award as final and binding under the prevailing rules of said
Association, and judgment upon the award may be had in any court having
jurisdiction. The duty to arbitrate shall survive the cancellation or
termination of this Agreement.
19.6 NOTICES
All notices, demands, requests or other communications which may be
or are required to be given, served, or sent by the University or the Sponsor
pursuant to this Agreement shall be in writing and shall be hand delivered
(including delivery by courier), sent by recognized overnight courier service,
mailed by first-class, registered or certified mail, return receipt requested,
postage prepaid, or transmitted by telegram, telex or facsimile transmission,
addressed as follows:
-12-
(i) If to the University:
Senior Associate Xxxx for Research
and Sponsored Programs
Cornell University Medical College
Room A131
0000 Xxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
With a copy (which shall not constitute notice) to:
Office of University Counsel
Cornell University Medical College
0000 Xxxx Xxxxxx
Xxx Xxxx, Xxx Xxxx 00000
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
(ii) If to the Sponsor:
President
GENVEC, INC.
00000 Xxxxxxxx Xxxxx
Xxxxxxxxx, XX 00000
With a copy to: Vice President, Corporate Development
Telephone: (000) 000-0000
Facsimile: (000) 000-0000
Notwithstanding the foregoing, each party may designate by notice in writing a
new address or facsimile number to which any notice, demand, request, or
communication may thereafter be so given, served, or sent. Each notice, demand,
request, or communication which shall be delivered, sent, mailed, or transmitted
in the manner described above, shall be deemed sufficiently given, served, sent,
or received for all purposes at such time as it is delivered to the addressee
(with an affidavit of personal delivery, the return receipt, the delivery
receipt, or (with respect to a telex or facsimile) the answer back being deemed
conclusive but not exclusive evidence of such delivery) or at such time as
delivery is refused by the addressee upon presentation.
-13-
19.7 SURVIVAL
It is the express intention and agreement of the parties that all
covenants, agreements, statements, representations, warranties and indemnities
made in this Agreement shall survive the execution and delivery of this
Agreement.
19.8 WAIVER
Neither the waiver by either party of a breach of or a default under
any of the provisions of this Agreement, nor the failure of a party, on one or
more occasions, to enforce any of the provisions of this Agreement or to
exercise any right, remedy, or privilege hereunder shall thereafter be construed
as a waiver of any subsequent breach or default of a similar nature, or as a
waiver of any such provisions, rights, remedies, or privileges hereunder.
19.9 EXERCISE OF RIGHTS
No failure or delay on the part of a party in exercising any right,
power, or privilege hereunder and no course of dealing between the parties shall
operate as a waiver thereof; nor shall any single or partial exercise of any
right, power, or privilege hereunder preclude any other or further exercise
thereof or the exercise of any other right, power, or privilege. The rights and
remedies herein expressly provided are cumulative and not exclusive of any other
rights or remedies which a party would otherwise have at law or in equity or
otherwise.
19.10 BINDING EFFECT
Subject to the provisions hereof restricting assignment, this
Agreement shall be binding upon and shall inure to the benefit of the parties
and their respective successors and permitted assigns.
19.11 ASSIGNMENT
This Agreement shall not be assigned by either party without the
prior written consent of the other party; provided, however, that the Sponsor
may assign this Agreement upon a merger or sale of all or substantially all of
the Sponsor's assets to the Sponsor's successor in business if such assignment
is approved by the University, such approval not to be unreasonably withheld.
Notwithstanding the foregoing, no assignment of this Agreement shall be valid
unless and until the Sponsor and the proposed assignee sign and deliver to the
University a written agreement, reasonably satisfactory to the University,
pursuant to which such assignee assumes and agrees to be fully responsible for
all obligations and liabilities of the Sponsor under this Agreement.
19.12 ENTIRE AGREEMENT
This Agreement and the License Agreement (including all exhibits and
appendices to each such agreement) and the Crystal Appointment Letter contain
the entire agreement between the parties with respect to the arrangements
contemplated hereby and thereby and supersede any and all prior
-14-
understandings or agreements between the parties with respect to such
arrangements; provided, the terms of the Material Transfer Agreement shall not
be amended or effected in any way by the execution of this Agreement or the
License Agreement. No amendments or changes to this Agreement shall be effective
unless made in writing and signed by the Xxxx of the Medical College and
authorized representatives of the Sponsor. All correspondence regarding terms of
this Agreement shall be sent as specified in Section 19.6.
19.13 PRONOUNS
All pronouns and any variations thereof shall be deemed to refer to
the masculine, feminine, neuter, singular, or plural, as the identity of the
person or entity may require.
19.14 HEADINGS
Article and Section headings contained in this Agreement are
inserted for convenience of reference only, shall not be deemed to be a part of
this Agreement for any purpose, and shall not in any way define or affect the
meaning, construction of scope of any of the provisions hereof.
19.15 GOVERNING LAW
This Agreement, the rights and obligations of the parties hereto,
and any claims or disputes relating thereto, shall be governed by and construed
in accordance with the laws of the State of New York (but not including the
choice of law rules thereof).
19.16 NONDISCRIMINATION
The University and the Sponsor shall not discriminate against any
employee or applicant for employment because of race, religion, national origin,
sex, age, or physical limitation.
19.17 EXECUTION IN COUNTERPARTS
This Agreement may be executed in as many fully executed
counterparts as may be convenient.
-15-
IN WITNESS WHEREOF, the parties and persons named below have executed
this Agreement, or caused this Agreement to be executed on their behalf, as of
the date first set forth above.
GENVEC, INC. CORNELL UNIVERSITY, FOR ITS MEDICAL
COLLEGE
-------------------------------- ------------------------------------
By: Xxxx Xxxxxxx, Ph.D. By:
President
Acknowledged and agreed as to roles as Principal INVESTIGATORS:
--------------------------------
Xxxxxx X. Crystal, M.D.
Chairman of the Department of Medicine of the Medical College
--------------------------------
By: Xxxxx X. Xxxxxxx, M.D.
-16-
APPENDIX 1: DEFINITIONS
As used in this Agreement, the capitalized terms set forth below shall have
forth below shall have the meanings set forth below:
TERM DEFINITION
---- ----------
Biological Research Material: Shall mean any protein, gene, gene
vector, plasmid or other construct,
cell line, hybridoma, antibody or
other similar biological materials or
derivatives or analogs thereof,
created by employees of Cornell
University and arising out of the
Sponsored Research (except to the
extent such biological material is
subject to the Material Transfer
Agreement).
Chairman: The Chairman or acting Chairman of
the Department of Medicine of the
Medical College of the University
(currently Xx. Xxxxxxx).
Xxxxxxx Appointment Letter: The letter agreement dated December
30, 1992 between the University and
Dr. Crystal relating to the
appointment of Dr. Crystal to the
Medical College faculty and certain
other matters (including Appendix A
to such letter, but not including the
Memorandum setting forth material
terms as mutually proposed between
the Sponsor and the University with
respect to the proposed and Exclusive
License Agreement).
Dr. Crystal: Xxxxxx X. Xxxxxxx, M.D., in his
capacity as a Professor of Medicine
at the Medical College, a paid
consultant and an equity holder of
the Sponsor and Chairman of the
Sponsor's Scientific Advisory Board.
For purposes of this Agreement, Dr.
Crystal shall be deemed to be an
employee of the University and shall
not be deemed to be an employee of
the Sponsor.
Xx. Xxxxxxx: Xxxxx X. Xxxxxxx, M.D., in his
current capacity as Chairman of the
Department of Medicine of the Medical
College.
Foundation: A wholly owned subsidiary of the
University, which (among other
things) holds ownership interests of
biological materials and patents
issued on inventions made by the
University's staff and administers
licenses in a manner consistent with
the University's Patent Policy.
Gene Therapy: The introduction of nucleic acid into
a person with the purpose of
modifying the functions or behaviors
of cells of the human body, either by
EX VIVO introduction of nucleic acid
into cells, which cells are later
introduced into such person's body,
or by IN VIVO introduction of nucleic
acid into the person's body, to be
incorporated into cells of such
person (nucleic acid being any
composition of matter that includes two
or more covalently joined nucleotides
and/or variants thereof, including,
without limitation, variants of the
phosphate, ribose sugar and/or
heterocyclic base portions thereof,
provided that such nucleotides and
variants comprise a substantial
component of such composition of
matter).
Laws: All applicable federal, state, local,
and foreign government laws, rules,
regulations, policies, and guidelines
(including, without limitation, those of
the U.S. Department of Health and Human
Services).
License Agreement: The certain Amended and Restated License
Agreement entered into as of March __,
1998 between the Foundation and the
Sponsor.
Material Transfer Agreement: The certain Material Transfer Agreement
entered into as of December 19, 1996
between the Medical Center and Sponsor.
Medical College: The Cornell University Medical
College.
Principal Investigators: Dr. Crystal and the Chairman,
jointly, in their capacity as joint
principal investigators with respect to
the Sponsored Research.
Securities Laws: Applicable federal and state
securities laws, rules, and
regulations.
Sponsor Materials: Any drugs, chemicals, and other
materials or compositions of matter
supplied by the Sponsor in
connection with the Sponsored
Research.
Sponsor: GenVec, Inc., and its successors and
permitted assigns pursuant to the
terms of this Agreement.
Sponsor Payments: The aggregate amount paid or to be paid
by the Sponsor in connection with the
Sponsored Research, in an amount not to
exceed Five Million Seven Hundred
Thousand dollars ($5,700,000.00)
(subject to adjustment as set forth in
the Agreement), payable over four years
from the date of this Agreement, as is
more fully set forth in EXHIBIT B
hereto.
Sponsored Research: The Gene Therapy research funded, in
whole or in part, by the Sponsor, or as
to which the parties hereafter may agree
in writing as being included in the
definition of "Sponsored Research"
hereunder, to be conducted by the
University under the joint supervision
of Dr. Crystal and the Chairman (or
other University designee) in accordance
with Section 3, and the other terms of
this Agreement and with University
Policies (it being understood that the
Sponsor shall be promptly notified of
any change in University policies that
will alter the Sponsored Research).
-2-
Sponsored Research Intellectual Individually and collectively, all
Property Rights: patent applications, patents, and
patentable discoveries and inventions
arising, in whole or in part, out of the
Sponsored Research that are first
conceived or discovered and/or reduced
to practice (i) by one or more employees
of the University, or (ii) jointly by
one or more employees of the University
and by one or more employees of the
Sponsor, or (iii) by one or more
inventors not employed in Dr. Crystal's
laboratory (if funds from Sponsor
Payments have been directly utilized to
make such invention), and all Biological
Research Materials and Technical
Information. The parties expect that due
to the level of Sponsor Payments
provided by the Sponsor all Gene Therapy
inventions first conceived or discovered
and/or reduced to practice in Dr.
Crystal's laboratory will fall within
the definition of "Sponsored Research
Intellectual Property Rights." Neither
this definition, nor any other provision
of this Agreement or the License
Agreement, shall give the Sponsor any
rights in any patent application,
patent, patentable discovery or
invention first conceived or discovered
and/or reduced to practice except as
described above, or directly or
indirectly related to or arising out of
Dr. Crystal's duties and
responsibilities for Medical College
programs outside Dr. Crystal's
laboratory including the CUMC gene
therapy core (provided no Sponsor
Payments are used in connection with
such activities); provided, however,
that the foregoing shall not affect the
Sponsor's right, pursuant to Article II
of the License Agreement, to have an
opportunity to negotiate with a
third-party joint inventor who is a
University employee without prior
Sponsor obligations.
Technical Information: Has the meaning given such term in
the License Agreement.
University: Cornell University, a not-for-profit
educational institution having corporate
powers under the laws of the State of
New York.
University Policies: University policies, as in effect and as
they may be modified from time to time,
including (without limitation) the
specific requirements and conditions
contained in the Crystal Appointment
Letter and Appendix A thereto,
appointment and promotion policies, the
Faculty Practice Plan Policies and
Administrative Procedures, and
University patent, conflict, consulting,
and other policies.
-3-
EXHIBIT B: PAYMENT SCHEDULE AND PRELIMINARY BUDGET
PAYMENT SCHEDULE
The Sponsor Payments to be made pursuant to Section 5 of the Prior and Section 5 of this shall be
payable as follows/1/:
PAYMENT AMOUNT DUE DATE
------------------ --------------
*
PRELIMINARY BUDGET
The parties currently expect that the University will use the Sponsor Payments
to support certain aspects of the Sponsored Research, as set forth below. The
parties acknowledge and agree, however, that the specified amounts and
categories are preliminary estimates only and that the timing and amounts of the
University's actual expenditures may differ from this preliminary budget.
Notwithstanding the foregoing, however, the Sponsor shall not be required to
make Sponsor Payments other than as set forth in Section 5 of the and this Exhibit B. The following amounts are in thousands:
5-YEAR
YEAR 1 YEAR 2 YEAR 3 YEAR 4 YEAR 5 TOTAL
-------- -------- -------- -------- -------- --------
Direct Costs/2/ * * * * * *
Equipment * * * * * *
Space Rental/3,3/ * * * * * *
Indirect Costs/4/ * * * * * *
Total/3/ * * * * * *
/1/ It is understood and agreed that all payments due Cornell under the
Prior prior to the Effective Date of this Agreement
(i.e., all payments due in the period June 1, 1993 - February 1, 1998) have been
paid in full prior to the Effective Date of this Agreement.
/2/ Includes reimbursement of a portion of the cost of *
/3/ Calculated on the basis of *
/4/ It is understood and agreed that all payments due to Cornell under
the Prior Sponsored Research Agreement prior to the Effective Date of this
Agreement (i.e., all payments due for years 1-5, which represent the period June
1, 1993 - February 1, 1998) have been paid in full prior to the Effective Date
of this Agreement. Any unexpended amounts of such funding shall be carried over
and used under this Agreement.
4-YEAR
EXTENSION
YEAR 6 YEAR 7 YEAR 8 YEAR 9 TOTAL
-------- -------- -------- -------- ---------
Direct Costs/
Equipment/5/ * * * * *
Space Rental/
Indirect Costs/4/ * * * * *
Total/3/ * * * * *
---------------------
/5/ Space Rental/Indirect Costs will not be adjusted, either upward or
downward, as a result of any change in anticipated mix of direct costs/equipment
expenditures.
-2-
EXHIBIT C: MATERIAL TRANSFER AGREEMENT
ID# 000007
MATERIAL TRANSFER AGREEMENT
This MATERIAL TRANSFER AGREEMENT (the "Agreement"), made effective as of
December 19, 1996 (the "Effective Date,"), is entered into by and between
GenVec. Inc., having a place of business at 00000 Xxxxxxxx Xxxxx, Xxxxxxxxx,
Xxxxxxxx 00000 ("GenVec") and the Cornell University Medical College, having, a
place of business at 0000 Xxxx Xxxxxx, Xxx Xxxx, Xxx Xxxx 00000 ("Recipient").
WHEREAS, GenVec and Cornell University have previously entered into that
certain Sponsored Research Agreement effective as of May 18, 1993 (the
"Sponsored Research Agreement"), in connection with Gene Therapy (as defined
therein), pursuant to which GenVec may supply proprietary biological materials
to Cornell University for use in such sponsored research; and
WHEREAS, Cornell University has requested that GenVec supply proprietary
biological materials, and GenVec is willing to provide Cornell University with
biological materials proprietary to GenVec in order to conduct research related
to Gene Therapy (the "Field'), subject to the terms and conditions set forth
below.
1. MATERIAL; RESEARCH. In consideration of the services provided by Recipient
and the rights obtained by GenVec under this Agreement, GenVec agrees to
provide Recipient with mutually agreed quantities of the biological
materials specified on Exhibit A and biological materials the properties
thereof as the parties agree to in the future or as have been previously
agreed to (the 'Material") as are reasonably available for the sole purpose
of allowing Recipient to undertake the Sponsored Research, as defined in
the Sponsored Research Agreement (the " Sponsored Research") in the
laboratories and under the supervision of Xx. Xxxxxx X. Xxxxxxx
("Scientist"), who is each employed by Recipient. The Materials shall not
be renamed (Materials which are distinct from the original, starting
material may be named with a name that contains the name of the starting
material).
2. TITLE TO MATERIALS. Company shall retain all title and interest in and to
the Materials. The Investigator shall not imply or represent to any person
that he/she is the owner of the Materials.
3. OTHER LIMITATIONS. Recipient and Scientist agree to: (i) use prudence and
reasonable care in the use, handling, storage, transportation, disposition,
and containment of Material, due to its experimental nature and unknown
characteristics; (ii) not administer or use Material in humans or in
contact with any cells or other material to be infused into humans under
any circumstance; (iii) refrain from using Material for any commercial
purpose outside of its relationship with GenVec, including, without
limitation. contract research, compound library screening, production of
manufacture of products for sale, or conduct research activities that may
result in the sale, lease. license, or transfer of Material to any entity
other than GenVec; and (iv) refrain from using Material in any research
other than the Sponsored Research without first obtaining GenVec's written
consent.
4. CONTROL OF MATERIAL. Recipient and Scientist agree to retain control over
Material and not to transfer Material to any third person or entity without
first obtaining GenVec's written consent. GenVec, reserves the right to
distribute Material to others and use Material without restriction for its
own purposes.
5. NO WARRANTY. Material is being made available in order to further research
and understanding with respect thereto. Accordingly, MATERIAL IS BEING
SUPPLIED "AS IS" WITH NO WARRANTIES EXPRESS OR IMPLIED, AND GENVEC
EXPRESSLY DISCLAIMS ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. Further, GenVec makes no representation that the use of
Material will not infringe the proprietary rights of any third party.
6. CONFIDENTIALITY. All oral or written Communications received by Recipient
and/or Scientist relating to Material are, and shall remain, proprietary
and confidential to GenVec, Provided that any oral disclosure is confirmed
by a written summary thereof sent to Recipient within fifteen (15) days of
such oral disclosure. Recipient and Scientist agree to hold all such
information in confidence and not to disclose such information to any third
party or use it for any purpose other thin to conduct the Sponsored
Research, except that Recipient and Scientist shall not be required to
maintain the confidentiality of information that (i) is already known to
Recipient or Scientist at the time of its disclosure by GenVec, as
evidenced by written records of Recipient or Scientist, (ii) has become
publicly known and generally available through no wrongful act of Recipient
or Scientist, or (iii) has been received by Recipient or Scientist from a
third party authorized to make such disclosure, as evidenced by written
records of Recipient or Scientist.
7. REPORTS. The Recipient agrees to provide periodic reports and meet with
GenVec representatives as specified in paragraphs 11.1 and 11.2 of the
Sponsored Research Agreement. The periodic and final reports, and the
underlying data, results, observations. and conclusions obtained or made as
a result of Recipients and scientists use of Material (individually or
collectively, the "Results"), shall be the property of GenVec, and each
report shall be sent to Dr. Xxxx Xxxxxxx, President and CEO of GenVec, or
in alternate GenVec designee. In addition, Recipient shall notify GenVec
promptly, but in no event take more than 30 days, of any invention.
discovery, idea or concept, patentable or otherwise, conceived, reduced to
practice, or otherwise developed, alone or jointly, during
-2-
the Sponsored Research and for a period of one (1) year thereafter that
incorporates or requires use of Material or that could not have been
conceived, reduced to practice, or otherwise developed without access to or
through the use or study of Material or conduct of the Sponsored Research
(each a "Development'). Notwithstanding the above, nothing in this section
shall be inconsistent with the Sponsored Research Agreement.
8. PUBLICATIONS. GenVec recognize that Recipient and Scientist may wish to
publish scientific articles, abstracts. or posters, or make oral
presentations relating to the Sponsored Research, and Recipient and
Scientist recognize that publication or other public disclosure of the
Results can jeopardize proprietary rights. including patent rights,
relating thereto. Therefore, Recipient agrees to provide GenVec with an
advance copy of any proposed publication, oral presentation, poster or
other disclosure intending to disseminate any or all of the Results at
least twenty (20) days prior to submission for publication, presentation,
or other disclosure. At GenVec's request, Recipient agrees to delete
confidential information of GenVec, and, if requested by GenVec within such
twenty (20) day period, to delay submission for publication, presentation,
or other disclosure for up to an additional ten days (10) to permit the
filing of one or more patent applications in respect of Developments. In
accordance with scientific custom, the contribution of GenVec will be
expressly noted in all written or oral public disclosures made by Recipient
or Scientist which relate to the Sponsored Research or Results, by
acknowledgment or co-authorship, as appropriate.
9. OWNERSHIP: PATENT PROSECUTION. Recipient and Scientist hereby grant GenVec
an exclusive, worldwide license, with the right to grant and authorize
sublicenses, under all Development and related intellectual property. No
additional compensation for such license shall be due Recipient other than
amounts, if any, that may be due under the Sponsored Research Agreement,
the Exclusive License Agreement between the Recipient and GenVec executed
May 18, 1993 and the Exclusive License Agreement between the Recipient and
GenVec executed July 10, 1995. Title to any intellectual property will be
as specified in Provision 16-1(b) of the Sponsored Research Agreement.
Patent counsel shall be acceptable to GenVec.
10. TERM: TERMINATION. The term of this Agreement shall be the same as the
Sponsored Research Agreement, unless modified by mutual written agreement,
except that either party can terminate this Agreement upon breach by the
other party. Within ten (10) days following completion of the Sponsored
Research or termination, all unused Materials shall, at GenVec's sole
option, be (i) returned to GenVec, or (ii) destroyed with written
certification of such destruction provided to GenVec. Any right or
obligation which accrues hereunder prior to the effective date of
expiration or termination shall survive such expiration or termination, as
will Sections 4-10, and 1 4.
-3-
11. NOTICE. Any notice to be given pursuant to this Agreement shall be made
and deemed effective as provided for in paragraph 19.6 of the Sponsored
Research Agreement. In addition. for notice to GenVec, Recipient agrees to
use the address first listed above in this Agreement, or such other address
as may be designated in writing by GenVec, and also provide a copy to Vice
President, Corporate Development.
12. RELATIONSHIP. The relationship created by this Agreement between GenVec
and Recipient shall be that of independent contractors without the
authority given to either party to bind of act as agent for the other or
its employees for any purpose.
13. PUBLICITY. Neither party shall use the name of the other in any public
announcement, publicity, or advertising with respect to the subject matter
of this Agreement, except as provided in Section 7. without the prior
written approval of the other party, unless reasonably necessary to comply
with applicable government law or regulation. Any publicity shall not be
inconsistent with Section 9 of the Sponsored Research Agreement.
14. WARRANTIES. GenVec and Recipient each warrant and represent that it has
the right to enter into this Agreement and that the terms of this Agreement
are not inconsistent with other contractual obligations, express or
implied, which it now has or will have during the term of this Agreement.
Recipient further warrants and represents that it and Scientist will comply
with all applicable government laws, regulations, and rules. including
guidelines for work with recombinant UNA. and that Material will be used
solely for in vitro research investigations or administration to laboratory
animals.
15. NO IMPLIED LICENSES. Except as expressly provided herein, GenVec does
not, by implication or otherwise, grant to Recipient any license or other
right with respect to Material, Developments, Results, or any intellectual
property relating to any of the foregoing.
16. ASSIGNMENT. Recipient may not assign its interest in this Agreement
without the prior written consent of GenVec. GenVec may assign its
interest in this Agreement and its rights hereunder.
17. GOVERNING LAW. This Agreement is to be governed by and interpreted in
accordance with the laws of the state of New York (but not including the
choice of law rules thereof).
18. UNDERSTANDING. This Agreement and Exhibits A set forth the entire
agreement between the parties with respect to the subject matter contained
herein and supersedes any previous understandings, commitments, or
agreements, whether oral or written, with respect to this subject matter.
The parties may, from time to time during the term of this Agreement,
modify of amend any of the provisions hereof only by an instrument duly
executed by both of the parties.
-4-
IN WITNESS WHEREOF, duly authorized representatives of GenVec and Recipient
have executed duplicate originals of this Agreement, and each original, alone or
in combination with the other, shall constitute one and the same instrument.
GENVEC, INC. Cornell University Medical College
By: By:
------------------------------ --------------------------------
Name (print): Name (print):
-------------------- ----------------------
Title: Title:
--------------------------- -----------------------------
Date: Date:
---------------------------- ------------------------------
Acknowledgment by Scientist:
-----------------------------------
By:
--------------------------------
Date:
------------------------------
-5-
EXHIBIT A
MATERIAL
For purposes of this Agreement, "Material' shall mean:
*
d. biological materials the parties agree to in the future;
e. any derivative, progeny, modification, or improvement of any of the
biological materials listed in parts (a) through (d) above conceived,
reduced to practice, or otherwise developed by or on behalf of
Recipient;
f. any mixture or combination of (a) through (e) above and other
substances.
g. any improvement of the biological materials listed in parts (a)
through (e) above conceived, reduced to practice, or otherwise
developed by or on behalf of Recipient which is not within the scope
of part (f) above; and
h. any other substance conceived, reduced to practice, or otherwise
developed by or on behalf of Recipient through use of any of the
foregoing.
-6-
PERSONAL & CONFIDENTIAL
-----------------------
December 30, 1992
Xxxxxx X. Xxxxxxx, M.D.
00000 Xxxx Xxxxx Xxxxx
Xxxxxxx, Xxxxxxxx 00000
Dear Xxx:
In accordance with our conversations, and upon your acceptance of the terms
and conditions contained herein, I am please to recommend to the Xxxx of Xxxxxxx
University Medical College ("CUMC") that you be appointed a full-time Professor
of Medicine with tenure and the Xxxxx Xxxxxxx Professor of Medicine at Cornell,
and I will recommend to the President of the New York Hospital that you be
appointed an Attending Physician there. I am also delighted to recommend that
you be appointed to the administrative position of Chief of the Division of
Pulmonary and Critical Care Medicine (the "Division") in the Department of
Medicine at The New York Hospital-Cornell Medical Center ("NYH-CMC").
Your base salary for the first academic year will be ________ and your
supplemental compensation will be _______ for a total compensation of
________. Your base salary will be paid by funds outside the Division;
however, it is expected that your supplemental compensation will be derived
from funds generated by the Division. Any grant funds generated for your
salary will be used to offset the departmental commitment for your base
salary.
Because you will provide clinical care services to patients, you are
required to participate in the CUMC Faculty Practice Plan. A copy of the Faculty
Practice Plan Policy and Administrative Procedures is available through the FPP
Office. I recommend that you read this document and have any questions answered.
Because you will have a guaranteed salary, Faculty Practice Plan policies have
been modified with respect to you so that clinical income generated as a result
of service provided by you will not be available to you should your employment
terminate.
You will be entitled to the fringe benefits generally applicable to the
faculty. Should you have specific questions regarding health or life insurance
coverage, pension plans, flexible benefits, or other benefits, the Benefits
Office at Cornell University can provide you with additional information.
The Department of Medicine (the "Department") will also provide an
additional compensation payment in an amount equal to the bonus you must return
to the Federal Government as a result of your departure. This amount will be
provided to you in the manner and time frame required by the Public Health
Service.
-7-
The Department will also provide a one-time payment of _______ for
expenses related to the creation of a household in New York.
Approximately 4000 square feet of research and office space initially will
be provided to you at MYH-CMC. This research suite will be renovated and
equipment will be supplied per your specifications, and it is expected that the
costs of these renovations and equipment will be funded, in part, by GenVec,
Inc. Within approximately two years of your employment at CUMC, an additional
2000 square feet of research space will be made available at MYH-CMC. Further,
approximately 4500 square feet will be provided for clinical administrative
activities. Additional research space and approximately six clinical beds may be
provided at Rockefeller, which would be arranged by Xx. Xxxxx Xxxxxx. Should
these beds and/or research space become unavailable at Rockefeller University, I
will attempt to replace them at Cornell. Space allocations may be reviewed in
the future, depending on available funding and your and CUMC's needs.
Financial support of up to $3,000,000 (in aggregate) will be provided to
the Division for a total of up to three years for the direct costs of junior
faculty, salaries, supplies, technical support, and the renovation and equipment
described in the previous paragraph. After that time, it is expected that the
Division will be self-supporting.
Compliance with the CUMC appointment and promotion policies, the Faculty
Practice Plan Policies and Administrative Procedures, and Cornell University
patent, conflict, consulting, and other policies (including, without limitation,
the specific requirements and conditions, attached hereto as Appendix A,
relating to your arrangements with GenVec, Inc. in the event that CUMC and
GenVec, Inc. have entered into a sponsored research agreement), as these
policies and procedures are in effect and as they may be modified from time to
time (collectively, "University Policies"), is a condition of employment.
Your major responsibilities will be those associated with the customary
functions and duties as Chief of the Division of Pulmonary and Critical Care
Medicine. As part of those responsibilities, you will undertake, to expand the
Division's clinical services, revitalize and develop the fellowship program,
provide significant involvement of the Division in medical student and residency
training, and develop the research capabilities of the Division.
Although it is anticipated that you may, from time to time, engage in
outside activities related to your research, you have acknowledged that (1) you
are a full-time employee of CUMC, and CUMC is your primary employer, and (2)
University, local, state and federal laws, rules, policies, guidelines, and
regulations which relate directly or indirectly to agreements of this type
supersede this arrangement. In making this offer, Cornell acknowledges that it
anticipates that you will be an equity holder, and a paid consultant (as
chairman of the Scientific Advisory Board) of GenVec, Inc., all subject to the
restrictions and conditions set forth in University Policies.
-8-
If you find this arrangement acceptable, please indicate your agreement
either by return letter or by signing the enclosed copy of this letter and
returning it to me. I will then begin the process of collecting and submitting
your appointment papers for University approval.
I look forward to having you join us at Cornell.
Sincerely,
Xxxxx X. Xxxxxxx, M.D.
(Appendix A attached)
Approved:
AGREED:
--------------------------------
Xxxxxx Xxxxxxx, M.D.
Xxxx, Xxxxxxx University Medical College ------------------------------
Xxxxxx X. Crystal, M.D.
Approved:
------------------------------
Date
--------------------------------
Xxxxx X. Xxxxxxx, M.D.
President, The New York Hospital
-9-
APPENDIX A TO DECEMBER 30, 1992 LETTER
FROM XX. XXXXX X. XXXXXXX TO XX. XXXXXX X. XXXXXXX
Set forth below are certain requirements and conditions with respect to the
proposed relationships among Cornell University for its Medical College
("CUMC"), and Xx. Xxxxxx X. Xxxxxxx ("Dr. Xxxxxxx"), and GenVec, Inc.
("GenVec"). As used herein, "GenVec" shall include GenVec and its affiliates,
successors, and assigns.
1. GENERAL
A. There shall be no financial payments, commitments, arrangements or
understandings between GenVec and Dr. Crystal or his family (including
his spouse, parents, siblings, children, and any other blood relative if
the latter resides in the same household with Dr. Crystal)
(collectively, his "Family", and neither Dr. Crystal nor his Family
shall have any debt or equity holdings in or with respect to GenVec
expect to the extent specifically permitted by this Appendix A.
B. An Oversight Committee shall be established by the Xxxx of CUMC, and
this Committee shall be empowered to undertake the responsibilities, and
shall have the full authority, described in Section II below.
C. By accepting employment with CUMC, Dr. Crystal acknowledges that he is a
full-time employee of CUMC, that CUMC is his primary employer, and that
his relationship with GenVec is superseded by the terms and conditions
of his offer of employment from CUMC and all CUMC appointment and
promotion policies, the Faculty Practice Plan policies and
administrative procedures, and Cornell University patent, conflict,
consulting, and other policies (including, without limitations, the
specific requirements and conditions set forth in this Appendix A), as
these policies and procedures are in effect and as they may be modified
from time to time (collectively, "University Policies").
D. By accepting employment with CUMC, Dr. Crystal represents that his
proposed arrangement with GenVec is consistent with the Department of
Health and Human Services and any other pertinent federal, state, and
local government (collectively herein "HHS"), laws, rules, regulations,
policies, and guidelines (collectively, "Laws"). Dr. Crystal (and, as it
deems appropriate, CUMC) will notify HHS of the full extent of the
arrangements, including any patent applications, and Dr. Crystal shall
advise CUMC of any HHS questions, concerns, or objections (collectively,
"Questions") to the arrangements as soon as Dr. Crystal learns of any
such Questions. CUMC may attempt to obtain from HHS acknowledgment that
the arrangements are acceptable and, if Questions are raised, CUMC may
amend the arrangements as they apply to Dr. Crystal and his
-10-
relationship with GenVec. By accepting employment with CUMC, Dr. Crystal
agrees that the terms and conditions set forth in this Appendix A may be
amended to the extent CUMC reasonably determines to be necessary or
appropriate to respond to HHS Questions or otherwise to comply with
applicable Laws.
E. Candidates for Ph.D. or Masters degrees shall not be assigned to GenVec-
sponsored research.
F. Dr. Crystal will promptly provide the Chairman of the Department of
Medicine and the Oversight Committee with full written disclosure
(including, without limitation, copies of any relevant agreements) of
each of his and his family's financial and other ties to and
arrangements with GenVec, whether direct or indirect (e.g., through
employment in companies that provide services to GenVec).
G. Dr. Crystal will abide by any changes in federal and state government
conflict of interest and other Laws. GenVec shall enter into an
agreement with CUMC reasonably satisfactory to CUMC to provide to
safeguards for CUMC (through "bailout" procedures) so that, if
applicable Laws, in the judgment of CUMC, warrant changes in the
arrangements with Dr. Crystal, CUMC will not be responsible for
administrative expenses and financial losses.
H. GenVec will be obligated under a sponsored research agreement reasonably
acceptable to CUMC to provide CUMC (for use with respect to Dr.
Crystal's research) with $9 million over five years. The agreement
between CUMC and GenVec will provide for a review by CUMC not later than
two years from the first date of Dr. Crystal's employment with CUMC
pursuant to which CUMC may determine, in its discretion, whether to
terminate the agreement before the end of the five-year term.
I. The nature of the arrangement between Dr. Crystal and GenVec will be
disclosed to all members of the CUMC Division of Pulmonary and Critical
Care Medicine (the "Division"), and all research in the Division will be
conducted in openness, subject to the review of the Oversight Committee.
J. Dr. Crystal's equity holdings shall be no greater than 5% of GenVec
equity (determined on a fully diluted basis). His consultant commitment
shall be no greater than the equivalent of one day per week and his
consultant remuneration shall be no greater than $100,000 per annum.
K. By accepting employment with CUMC, Dr. Crystal agrees that, if Laws or
University Policies change in such a way that, as determined by CUMC in
its
-11-
reasonable discretion, these arrangements are no longer permissible or
advisable (in whole or in part), Dr. Crystal shall modify his
arrangements, in a manner reasonably acceptable to CUMC, in order to be
in full compliance therewith.
L. Dr. Crystal's equity in GenVec (and any equity held by or for the
benefit of his Family) will be held in a trust outside of his control
(in form agreeable to CUMC), and the equity can be transferred
(including, without limitation, sold, given away, or pledged) only after
one of the following trigger events: at any time after final FDA
approval of the first product resulting from GenVec-sponsored research
at Cornell; withdrawal of any IND and cessation of clinical research;
upon the sale of GenVec in its entirety to an established
publicly-traded corporation; if required by any HHS or other Laws; or
one year after the termination of GenVec-sponsored research at Cornell.
M. Dr. Crystal will only be permitted to do initial clinical research
feasibility or Phase I studies relating to his GenVec-sponsored or
related research. Phase II and III clinical trials for FDA approval must
be done entirely by independent investigators.
N. Dr. Crystal's supervisor, the Chairman of the Department of Medicine,
shall be a co-principal investigator on all research proposals to
GenVec.
II. OVERSIGHT COMMITTEE. The recommendations made from time to time by an
Oversight Committee if and to the extent that such recommendations are
adopted by the Xxxx of CUMC shall be conditions of Dr. Crystal's employment
at CUMC.
A. The Oversight Committee shall consist of three or more members. All of
the initially appointed members shall have been appointed by the Xxxx of
CUMC (and shall have accepted such appointment) prior to final approval
by CUMC of the arrangements among CUMC, GenVec, and Dr. Crystal. A
senior faculty member from another Department at CUMC shall serve as
chair of the Oversight Committee. The remaining Oversight Committee
members shall include one internationally recognized senior scientist
from another institution and a second individual who is scientifically
expert in the subject of gene therapy.
B. The Chairman of the Department of Medicine will meet with the Oversight
Committee and report to it with respect to the operations of the
Division.
C. The Committee shall have full access to outside legal counsel to be used
as deemed necessary by the Committee. The existence and availability of
said outside counsel shall be made known, to all members of the
Division.
D. Members of the Oversight Committee shall serve in office for so long as
the Xxxx
-12-
of CUMC may from time to time determine.
E. The Oversight Committee shall meet at least three times a year to review
all activities in the Division. The minutes of each meeting shall be
submitted to the Xxxx of CUMC.
F. Dr. Crystal shall prepare annual research plans and budget
justifications for the GenVec-sponsored research. These proposals shall
be reviewed and approved by the Oversight Committee before CUMC may
release GenVec research funds to Dr. Crystal.
G. Dr. Crystal shall prepare progress reports not less frequently than
every six months on the GenVec-funded research. These progress reports
shall include complete and accurate descriptions of all such research
and all doctoral scientists working on the project. The progress reports
are to be reviewed by the Oversight Committee.
H. The Oversight Committee's functions will include:
1. Vigilance over the research operation covered by any research and
licensing agreements with GenVec including, but not limited to:
(a) Review of research proposals and grants;
(b) Review of conduct and performance of research in progress;
and
(c) Review of publication patterns.
2. Promoting and evaluating appropriate disclosure in all publications
and funding applications.
3. Evaluating periodic reports by the investigator.
4. Reviewing the need for continued involvement in the sponsored
research.
5. Maintaining distinction in the laboratory between GenVec-sponsored
and other research, and monitoring student and post-doctoral
associate assignments.
6. Monitoring compliance with CUMC academic freedom, publication, and
confidentiality policies with regard to information made available to
GenVec.
-13-
J. The Oversight Committee shall be responsible for making recommendations
to the Xxxx of CUMC to protect CUMC's interests in all dealings between
or among Dr. Crystal, GenVec, and any potentially relevant third
parties.
K. The Oversight Committee may make such other recommendations to the Xxxx
of CUMC with respect to matters related to its areas of involvement as
are in its discretion appropriate.
L. In the exercise of its functions and responsibilities, the Oversight
Committee will use reasonable efforts, based on information then
available to it. Dr. Crystal shall be primarily responsible (acting in
consultation with the Chairman of the Department of Medicine) for
supplying information necessary to enable the Oversight Committee to
fulfill its functions and responsibilities as described in this Appendix
A.
-14-
MEMORANDUM
----------
The purpose of this Memorandum is to set forth material terms as mutually
proposed between GenVec, Inc. (the "Sponsor") and Cornell Research Foundation,
Inc./Cornell University for its Medical College (the "University") with respect
to the proposed Sponsored Research Agreement and accompanying Exclusive License
Agreement respecting activities relating to Gene Therapy to be conducted in the
University laboratory of Xx. Xxxxxx X. Xxxxxxx ("Dr. Xxxxxxx").
A. SPONSORED RESEARCH AGREEMENT:
1. AMOUNT AND PAYMENT SCHEDULE - $9,000,000 payable as set forth in the
budget attached hereto as Schedule A.
2. SCOPE OF RESEARCH - Research in connection with gene therapy ("Gene
Therapy"), which is the transfer of nucleic acid to cells of the body, either IN
VIVO or EX VIVO, with the purpose of modifying the functions or behavior of
those cells. (Nuclear acid is any composition of matter that includes two or
more ribonuclectides and/or decxyribonucleotides.)
3. TERM - Five (5) years, unless earlier terminated in the event of the
death, disability or termination of the appointment of Dr. Crystal or
termination for cause as set forth in Section 15, below. In the event of any
termination hereunder, (i) the non-cancelable obligations of the University will
be honored by Sponsor; and (ii) Sponsor shall retain any property or
-15-
exclusive license rights with respect to inventions duly disclosed prior to
termination in accordance with University's prevailing policies, which include
timely submission of Record of Invention forms.
4. SCOPE OF RESEARCH SUPPORT - Sponsor's funds will be used over the life
of the Agreement for the rental of space for Dr. Crystal's lab, the bulk of the
equipment in Dr. Crystal's lab, a portion of Dr. Crystal's salary, and general
research support for pre-clinical feasibility projects and clinical evaluation
of Gene Therapy technology (excluding Phase II and Phase III studies), including
support of other members of Dr. Crystal's laboratory, all of whom will be
employees of the University.
5. PRINCIPAL INVESTIGATOR - The Principal Investigators ("PI") will be
Dr. Crystal and the chairman of the Department of Medicine, who will jointly
supervise the project. It is acknowledged that Dr. Crystal will be an equity
holder and paid consultant of Sponsor and Chairman of its Scientific Advisory
Board. Initial human feasibility trials will take place at the University, under
the direction of PI, but Phase II and Phase III trials are expected to take
place at independent sites under the supervision of independent investigators.
6. INVENTIONS AND PATENTS - Inventions and discoveries made during the
course of the Sponsored Research and within its scope will be owned by the
University, subject to an exclusive license to Sponsor, and Sponsor and the
University shall jointly be involved with prosecuting all
-16-
patents with respect to technology arising out of the Sponsored Research on a
basis which is mutually agreeable. Disclosure of inventions shall simultaneously
be made by the PI to the University and Sponsor.
7. PUBLICATIONS - PI and others involved in the Sponsored Research shall
be free to publish papers describing developments arising out of the Sponsored
Research. Sponsor shall have the ability to review any publications prior to
submission in order to begin the patenting process if Sponsor deems it
appropriate. Sponsor will participate in the patenting process in a timely
fashion so as not to delay the publication unreasonably.
8. PROPRIETARY DATA AND MATERIALS PROVIDED BY SPONSOR - The PI may accept
from time to time proprietary data or biological materials from Sponsor for use
in the Sponsored Research, subject to prevailing University policies and
practices. Such proprietary data will be marked or designated in writing as
confidential property of Sponsor and the University will use its best efforts to
hold such data confidential.
9. USE OF NAME - Neither party will use the other's name without written
consent, which will not unreasonably be withheld, except as required by law,
including securities laws, rules and regulations. With respect to the latter,
Sponsor may be required to disclose material terms of the Agreement, but will
use reasonable efforts, unless the University otherwise consents, not to use the
name of University.
-17-
10. NO SOLICITATION ACTIVITIES - Laboratory personnel, including Dr.
Crystal, will not engage in solicitation of the sale of securities of Sponsor,
but may participate in connection with the due diligence with potential
investors and underwriters in describing the Gene Therapy research and
responding to questions.
11. TITLE TO EQUIPMENT AND DATA - Title to Equipment and research data
shall belong to the University, in a manner consistent with University policies
and customs with respect thereto. Provided, however, that Sponsor shall have the
right to receive copies of any related research data on reasonable request.
12. USE OF DRUGS/CHEMICALS - Sponsor will accept back any unused portions
of drugs/chemicals supplied by Sponsor and Sponsor will indemnify the University
with respect to damage caused by xxx of such drugs/chemicals pursuant to
Sponsor's direction. In addition, on request of the PI, Sponsor shall furnish
sufficient information for each drug/chemical supplied by Sponsor, to the extent
known, to permit reasonable interpretation of the results obtained in the
Sponsored Research.
13. ACKNOWLEDGMENT AND UNDERTAKING BY SPONSOR RESPECTING DR. CRYSTAL -
Sponsor will acknowledge that it has been informed of the terms and conditions
of the employment of Dr. Crystal at the University and Sponsor agrees that it
will use reasonable care such that nothing requested by Sponsor of Dr. Crystal
will violate any of the duties or obligations of Dr. Crystal to the University.
Nothing in those Agreements will impair the rights of the University or the PI
to
-18-
determine the nature and scope of Sponsored Research, or Dr. Crystal's other
research at the University, in a manner consistent with University policy. The
University undertakes to notify Sponsor of any changes in the terms and
conditions of Dr. Crystal's employment material to Sponsor, in the University's
reasonable judgment.
14. ENFORCEMENT OF UNIVERSITY RULES - The University will agree to use its
best efforts to enforce observance by all University personnel engaged in the
Sponsored Research with respect to the University Patent Policy, and rules for
disclosure respecting ownership of biological materials obtained in connection
with the Sponsored Research from others, and all other pertinent University
rules and regulations impacting on the entitlements of Sponsor.
15. TERMINATION FOR CAUSE. Either party hereto shall have the right to
terminate the Agreement in the event that (i) in the reasonable judgment of the
terminating party termination is necessitated by reason of a change in
prevailing laws, regulation or government rules, guidelines or policies relating
thereto (provided that GenVec will not use as a ground of termination such a
change which could be cured by a revision of Dr. Crystal's relationship with
GenVec) or (ii) the terminating party has a reasonable basis to believe that the
other party has engaged in unlawful, unethical or seriously inappropriate
conduct such that continued performance of the Agreement would affront
significant legitimate interests of the terminating party. In the event of any
disagreement by the terminated party with respect to the reasonableness of the
alleged grounds for termination under this paragraph, the disagreement will be
resolved by a mutually agreeable third party arbitrator.
-19-
B. LICENSE AGREEMENT.
1. SCOPE OF EXCLUSIVE LICENSE - As stated above with respect to the
Sponsored Research, it is anticipated that funding provided by Sponsor will be
utilized to support, at least in part, all activities in Dr. Crystal's
laboratory, including but not limited to funding for personnel, space and
equipment. It is anticipated, therefore, that all Gene Therapy discoveries made
in that laboratory during the term of this Agreement will utilize such funding.
Accordingly, it is anticipated that Sponsor will obtain exclusive rights to all
such Gene Therapy technology (subject only to prevailing U.S. government rights
with respect to ownership of intellectual property derived in the course of
federally sponsored research) at a royalty rate of between * of net sales,
depending on the inherent value of the Technology and limited in the case of the
Cystic Fibrosis field by royalty burdens to other parties.
2. UNIVERSITY CONDUCT - The University agrees that it will not knowingly
take any actions inconsistent with the exclusive licensing arrangements outlined
above and the University will make reasonable efforts with respect to observance
of University rules by personnel engaged in the laboratory.
3. RIGHT TO SUBLICENSE. Sponsor shall have the right to sublicense to
third parties, with the written consent of the University. Sponsor shall make
all reasonable efforts to insure
-20-
that sublicensees perform the terms and conditions of the License Agreement
beneficial to the University.
4. MINIMUM ROYALTIES - Beginning with the filing of the first patent
application with respect to a Gene Therapy discovery licensed to Sponsor, it
will pay a minimum royalty of * per year thereafter for each such discovery up
to a maximum for all discoveries of * per annum and discussion will be held with
respect to credit being given for any uncredited portions of minimum royalties
for prior years.
5. LIMITED RENEGOTIATION RIGHTS FOR ROYALTY RATES IF REQUIRED UNDER TAX
REFORM ACT OF 186 ("TEFRA") - Sponsor and the University have determined that
the royalty range and criteria as set forth above are fair and competitive with
respect to the all reasonably conceivable discoveries to arise out of the
Sponsored Research. In the unanticipated event that inventions arise which are
not reasonably conceivable such that any renegotiation is required under TEFRA,
acceptable procedures have been worked out for such renegotiation process
consistent with provisions set forth in the University's draft License Agreement
submitted to Sponsor.
6. PATENT INFRINGEMENT ACTIONS - University shall determine initially
whether or not to prosecute patent infringement actions, subject to Sponsor's
right to join and participate in the litigation.
-21-
7. ARBITRATION OF DISPUTES - All disputes under the License Agreement
will be resolved through Arbitration, including any disagreement with respect to
specific royalty rate within the agreed upon range.
8. PATENT LICENSE PROVISIONS - The Agreement will include mutually
agreeable provisions respecting intellectual property protection, accounting for
royalty payments, exercise by Sponsor of efforts respecting commercialization of
licensed products and the like.
9. TERMINATION. The grounds for termination of the License Agreement and
the rights of the parties after termination, will be co-extensive with those
under the Sponsored Research Agreement.
C. EFFECT OF THIS MEMORANDUM
Execution of this Memorandum by the parties will not give rise to a binding
legal agreement but will form the basis for preparation of Agreements
incorporating the terms hereof together with representations, warranties,
conditions, indemnification rights and other provisions that the parties elect
to include.
CORNELL UNIVERSITY FOR ITS MEDICAL COLLEGE
By:
-----------------------------
-22-
CORNELL RESEARCH FOUNDATION, INC.
By:
-----------------------------
GENVEC, INC.
By:
-----------------------------
ACKNOWLEDGED:
------------------------------
Xx. Xxxxxx X. Xxxxxxx
------------------------------
Xx. Xxxxx X. Xxxxxxx
-23-
SCHEDULE A
PROPOSED GENVEC SPONSORED RESEARCH
Year 1 Year 2 Year 3 Year 4 Year 5 5 Year Total
1 Direct Costs 261 1,011 636 636 636 3,180
2 Equipment 2,000 500 500 500 500 4,000
3 Space rental (5,800 sq ft. x 840 sq. 152 152 152 152 152 760
ft)
4 Indirect cost (33 1/3%) 87 337 212 212 212 1,060
----- ----- ----- ----- ----- -----
Total 2,500 2,000 1,500 1,500 1,500 9,000
1 A very small portion of direct costs will go to support Xxx Crystal's
salary and related fringe benefit costs
2 Money will be shifted from direct costs if equipment and renovation
actual costs are higher than the above estimates
3 As charged by New York Hospital if in New York Hospital space or Cornell
costs is in Cornell space
4 Non facility component of federal indirect cost rate as negotiated
annually; applicable to direct cost (Line 1) only
-24-
