DEVELOPMENT AGREEMENTResearch and Development Agreement |
|
|
|
You are currently viewing: This Research and Development Agreement involves
CardioVascular BioTherapeutics, Inc | ProDerm, LP | VD-1, LLC. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here. |
|
|
|
Search Research and Development Agreement by:
DEVELOPMENT
AGREEMENT
BETWEEN
CARDIOVASCULAR
BIOTHERAPEUTICS, INC.
AND
PRODERM,
LP
Dated
as of July 8, 2008
TABLE
OF CONTENTS
|
Page
|
|||
|
1.
|
Definitions
|
1
|
|
|
|
1.1
|
Definitions
|
1
|
|
1.2
|
Singular
and Plural
|
1
|
|
|
2.
|
Description
of Technology / Goal of Development
|
1
|
|
|
3.
|
Development
Services
|
2
|
|
|
3.1
|
License
|
2
|
|
|
3.2
|
Development
|
2
|
|
|
3.3
|
Disclaimer
of Warranties
|
3
|
|
|
3.4
|
Rights
to Property
|
3
|
|
|
3.5
|
Reports
and Records.
|
3
|
|
|
3.6
|
Other
Activities
|
4
|
|
|
4.
|
Development
Fee
|
4
|
|
|
5.
|
Revenue
Sharing from Product Sales
|
4
|
|
|
6.
|
Representations
and Warranties of CVBT
|
5
|
|
|
6.1
|
Organization
|
5
|
|
|
6.2
|
Authorization
|
5
|
|
|
6.3
|
Intellectual
Property Rights
|
5
|
|
|
7.
|
Representations,
Warranties and Covenants of PDLP
|
5
|
|
|
8.
|
Insurance
|
5
|
|
|
9.
|
Term
and Termination
|
5
|
|
|
9.1
|
Term
|
5
|
|
|
9.2
|
Events
of Termination.
|
6
|
|
|
9.3
|
Effect
of Termination
|
6
|
|
|
10.
|
Indemnification
|
6
|
|
|
10.1
|
Indemnification
by CVBT
|
6
|
|
|
10.2
|
Indemnification
by PDLP
|
6
|
|
|
10.3
|
Defense
of Claims
|
7
|
|
|
10.4
|
Consequential
Damages
|
7
|
|
|
11.
|
Miscellaneous
|
7
|
|
|
11.1
|
No
Implied Waivers; Rights Cumulative
|
7
|
|
|
11.2
|
Force
Majeure
|
7
|
|
|
11.3
|
Relationship
of the Parties
|
7
|
|
|
11.4
|
Notices
|
8
|
|
|
11.5
|
Successors
and Assigns
|
8
|
|
|
11.6
|
Amendments
|
9
|
|
|
11.7
|
Governing
Law
|
9
|
|
i
|
11.8
|
Taxes
|
9
|
|
|
11.9
|
Severability
|
9
|
|
|
11.10
|
Confidentiality
|
10
|
|
|
11.11
|
Trading
Limitations
|
10
|
|
|
11.12
|
Counterparts
|
10
|
|
|
11.13
|
Entire
Agreement
|
10
|
SCHEDULES
|
1.1
|
Definitions
|
|
|
2.1
|
Description
of Wound Healing IP
|
|
|
3.1
|
Technology
License Agreement
|
|
|
3.2.1
|
Work
Plan
|
|
|
4
|
Development
Fee
|
ii
DEVELOPMENT
AGREEMENT
This
Development Agreement (the “Agreement”) is made as
of July 8, 2008, by and between CardioVascular
BioTherapeutics, Inc., a Delaware corporation
(“CVBT”), and ProDerm, LP, a Nevada limited
partnership (“PDLP”).
RECITALS
A.
CVBT
has developed certain intellectual property regarding a
potential drug for wound healing (the “Wound Healing
IP”) and is willing to license to PDLP the Wound Healing
IP for the purpose of further developing the Wound Healing IP
and advancing a potential wound healing drug in the FDA
Process.
B.
CVBT
has experience in the development of pharmaceutical products
and has, or has access to, the facilities, equipment,
employees and other resources to accomplish development
activities, on behalf of PDLP, with respect to the Wound
Healing IP.
C.
PDLP
desires to engage CVBT to perform such services in connection
with the Development, and CVBT is willing to provide such
services.
NOW,
THEREFORE, in consideration of the mutual covenants set forth
herein and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, and
in order to induce CVBT to enter into the Agreements, CVBT and
PDLP hereby agree as follows:
1.
Definitions .
1.1
Definitions .
All capitalized terms used herein and not otherwise defined shall
have the respective meanings, to the extent such terms are used
herein, set forth in Schedule 1.1 attached hereto, which is
incorporated by this reference as though fully set forth
herein.
1.2
Singular and Plural .
Singular and plural forms, as the case may be, of terms defined
herein shall have correlative meanings.
2.
Description of Technology / Goal of Development
.
The Wound Healing IP is described in Schedule 2.1 attached hereto
and incorporated herein by this reference. The goal of the
Development is to advance the Wound Healing IP in the FDA Process.
The parties hereto understand and acknowledge that the goal of the
Development conducted under this Agreement is to result in a wound
healing drug that has been authorized for commercial exploitation
by the FDA and further, both parties understand and acknowledge
that there is no guarantee that the development conducted under
this Agreement will result in a wound healing drug authorized by
the FDA for commercial exploitation.
3.
Development Services .
3.1
License .
Pursuant to the Technology License Agreement of even date herewith,
a copy of which is attached hereto as Schedule 3.1, CVBT has
licensed to PDLP the Wound Healing IP on a nonexclusive basis for
the purpose of permitting PDLP to participate with CVBT in the
Development. PDLP acknowledges that CVBT has pledged its interest
in the Wound Healing IP as collateral for a prior loan financing
entered into on March 20, 2006 as further described on Form 8-K
filed on March 22, 2006 with a remaining balance due as of June 3,
2008 of $2,680,000 and that the rights of such lender are superior
to those of PDLP. PDLP further acknowledges and understands that
CVBT may enter into future research and development arrangements to
further the advancement of the Wound Healing IP and related
potential drug candidate, and that the rights of such research and
development partnerships will be pari passu with those of
PDLP. CVBT
agrees to not enter in research and development arrangements that
will result in aggregating more than 50% of revenue due to these
arrangements during the period of time that R&D LP is still due
any royalty under this Agreement.
3.2
Development .
PDLP hereby engages CVBT, and CVBT hereby accepts such engagement,
to use commercially reasonable efforts to undertake the
Development. Such services shall be provided as
follows:
3.2.1
Work Plan .
The proposed work plan is attached as Schedule 3.2.1 and
incorporated herein by this reference. The work plan may be revised
by CVBT upon written notice to PDLP.
3.2.2
Conduct of Development .
During the term of this Agreement, CVBT shall use commercially
reasonable efforts to (a) conduct the Development on behalf of PDLP
in a prudent and skillful manner in accordance, in all material
respects, with the work plan then in effect and applicable laws,
ordinances, rules, regulations, orders, licenses and other
requirements now or hereafter in effect and (b) diligently execute
such work plan and report to PDLP any significant deviations
therefrom in a timely manner. PDLP hereby appoints CVBT its
exclusive agent, for the term of this Agreement, with the sole
power and authority to file and prosecute all necessary regulatory
applications and permits in CVBT’s name required to obtain
FDA and other regulatory approvals for CVBT’s Development
efforts. Without limiting the generality of the foregoing sentence,
absent specific requirements of the FDA to the contrary, CVBT is
authorized by PDLP to conduct FDA trials in CVBT’s name.
Using the Available Funds provided by PDLP, CVBT shall furnish all
labor, supervision, services, supplies and materials necessary to
perform the Development in accordance with the work plan then in
effect. In addition, CVBT agrees to use commercially reasonable
efforts, on behalf of itself and PDLP, to attempt to obtain and to
sublicense any patent or technology license or sublicense from any
Person, including CVBT, that CVBT reasonably determines to be
necessary or useful to enable CVBT to conduct the Development under
this Agreement.
3.2.3
Subcontracts .
PDLP acknowledges that CVBT may elect to subcontract to third
parties a portion of the Development. PDLP acknowledges and agrees
that in performing the Development, CVBT may, and is hereby
authorized to, without the prior written consent of PDLP, engage or
agree or otherwise collaborate with other Persons, including,
without limitation, Affiliates of CVBT or entities performing other
development activities for CVBT, to provide assistance in carrying
out the Development.
2
3.3
Disclaimer of Warranties .
CVBT cannot and does not guarantee that the Development will be
successful in whole or in part or that any significant advancement
in the FDA Process will occur. To the extent that CVBT has complied
with Section 3.2.2 hereof, the failure of CVBT to further develop
successfully the Wound Healing IP will not in and of itself
constitute a breach by CVBT of any representation, warranty,
covenant or other obligation under the Agreements. In addition,
neither CVBT nor PDLP makes any representation or warranty or
guaranty that the development fee described in Section 4 will be
sufficient for the completion of the Development contemplated in
the work plan. Furthermore, nothing in this Agreement shall be
construed as a representation made or warranty given that any
patents or other registrable technology will issue from the
Development. PDLP understands that the Development shall involve
technologies that have not been approved by any regulatory
authority and that CVBT does not guaranty the safety,
effectiveness, performance or usefulness of any drug or technology
that results from the Development.
3.4
Rights to Property .
All right, title and interest to the data, know-how and
enhancements of the Wound Healing IP and any other intellectual
property resulting from the Development acquired or developed
pursuant to this Agreement (the “Program IP”) including
any submissions or applications to the FDA or any foreign
equivalent made by CVBT in its name on behalf of itself or PDLP
shall be the exclusive property of PDLP; provided, however, that
such right, title and interest shall be subject in all events to
that certain exclusive license agreement of even date herewith
attached hereto as Schedule 3.1 and incorporated herein by this
reference; and provided further, that PDLP shall have no right to
physical possession of the Program IP.
3.5
Reports and Records .
3.5.1
Progress Reports .
Within 30 days after the end of each calendar quarter during the
term of this Agreement, CVBT shall deliver to PDLP a report setting
forth in reasonable detail a summary of the work performed pursuant
to the work plan during the immediately preceding calendar
quarter.
3.5.2
Financial Reports .
Within five (5) business days after the filing of its Form 10-Q
with the SEC for the first three calendar quarters of each calendar
year during the term of this Agreement, CVBT shall provide to PDLP
(a) a reasonably detailed report setting forth in respect of such
quarter the revenues collected by CVBT based on the exploitation of
any wound healing drug developed as a partial result of the
Development, and (b) a check payable to PDLP in an amount equal to
the amount calculated pursuant to Section 5 hereof for that
quarterly period. Within five (5) business days after CVBT files
its Form 10-K with the SEC, it shall provide to PDLP an audited
report of the revenues collected by CVBT based on the exploitation
of any wound healing drug developed as a partial result of the
Development for the prior fiscal year of CVBT. Any adjustments to
the amounts paid or payable to PDLP shall be made as a result of
such audit at the time of delivery of such audit, and an
appropriate payment will be made to PDLP.
3
3.5.3
Final Report .
CVBT shall prepare a final report, within 90 days after the
expiration or termination of this Agreement, setting forth in
reasonable detail a summary of the work performed since the last
report provided to PDLP hereunder and the material developments
with respect thereto and containing a final statement of, and
payment based on, all applicable collected revenues upon which
payment to PDLP pursuant to Section 5 hereof are based and deliver
such report to PDLP.
3.5.4
Records/Review of Records .
CVBT shall keep and maintain proper and complete records and books
of account documenting all of its collected revenues based on the
exploitation of any wound healing drug developed as a partial
result of the Development. At PDLP’s request and expense,
CVBT shall permit a certified independent public accountant
selected by PDLP to have access, no more than once in each calendar
year during the term of this Agreement and each year for three
calendar years following the termination hereof, during regular
business hours and upon reasonable notice to CVBT, to such records
and books for the sole purpose of determining the accuracy of the
collected revenues reports. If such certified independent public
accountant reasonably determines that the collected revenues
reported have been, for any calendar year understated by CVBT by an
amount equal to or greater than five percent, CVBT shall promptly
forward any such underpayment to PDLP and pay all reasonable fees
and disbursements of such certified independent public accountant
incurred in the course of making such determination. If such
accountant reports an underpayment by CVBT of less than five
percent, CVBT shall forward such underpayment to PDLP and PDLP
shall pay all fees and expenses of such accountant. If such
accountant reports an overpayment by CVBT, PDLP will repay such
overpayment and bear all fees and expenses of such
accountant.
3.6
Other Activities .
During the term of this Agreement, CVBT shall devote such time and
effort to the performance of services pursuant to this Agreement as
may be necessary or appropriate to fulfill its duties under this
Agreement; provided, however, it is specifically understood and
agreed by PDLP that CVBT shall not be required to devote itself, on
a full-time basis, to the provision of such services and that CVBT
shall have the right to engage in its own development activities
for other drug candidates and in other business activities with
other Persons, and PDLP shall not, by virtue of this Agreement,
have any right, title or interest in or to such independent
activities or to the income or profits derived therefrom and,
without limiting CVBT’s obligation to use commercially
reasonable efforts to provide certain services hereunder, nothing
set forth in this Agreement shall limit or reduce the ability of
CVBT to carry on such other activities.
4.
Development Fee .
The nonrefundable fee for the Development contemplated herein is
set forth on Schedule 4 hereto which is incorporated herein by this
reference. PDLP hereby acknowledges that CVBT has in no way
guaranteed any particular results from the Development; that,
indeed, there may be no positive results from the Development; and
that, as a consequence, it may receive no return of, or on, the
Investment.
5.
Revenue Sharing from Product Sales .
If, as a result of the Development, as well as additional and
subsequent development of the Wound Healing IP, CVBT is able to
commercialize or in any other way exploit value from the Wound
Healing IP, PDLP will be entitled to ten percent (10%) of the gross
cash actually collected by CVBT based on CVBT’s exploitation
of the wound healing drug (the participation). Such exploitation
may include, without limitation, direct marketing by CVBT or its
Affiliates and/or marketing, licensing, and/or partnering
arrangements with other pharmaceutical companies. Payment of such
amounts shall be made contemporaneously with the quarterly and
annual revenue reports described in Section 3.5 hereof up to a
maximum amount of the total Investment multiplied by twenty
(20).
4
6.
Representations and Warranties of CVBT .
CVBT represents and warrants to PDLP as follows:
6.1
Organization .
CVBT is a corporation duly organized, validly existing and in good
standing under the laws of the State of Delaware with full
corporate power and authority adequate for executing, delivering
and performing its obligations under the Agreements.
6.2
Authorization .
The execution, delivery and performance of the Agreements have been
duly authorized by all necessary corporate action on the party of
CVBT and the Agreements shall constitute legal, valid and binding
obligations of CVBT, enforceable against CVBT in accordance with
its terms, subject to laws of general application related to
bankruptcy, insolvency and the relief of debtors.
6.3
Intellectual Property Rights .
To the best of its knowledge, CVBT believes it has sufficient legal
and/or beneficial title and ownership to the technology described
on Schedule 2.1 hereof to license to PDLP the Wound Healing IP as
contemplated by this Agreement in Section 3.1 and in the Technology
Agreement. CVBT is not aware of, and has not received any
communications alleging that, it has violated, or that PDLP, by
participating in the development of the Wound Healing IP as
contemplated in this Agreement, would violate, any intellectual
property rights of any third party. To the best of CVBT’s
knowledge, there is no material unauthorized use, infringement or
misappropriation of any of the technology described in Schedule 2.1
hereto. CVBT is not aware of, nor has it received any
communications challenging, the ownership, validity or
effectiveness of the technology in Schedule 2.1.
7.
Representations, Warranties and Covenants of PDLP
.
The representations, warranties and covenants of PDLP set forth in
Section 3.2 o






