Cardio Derma Clinical Partners Agreement
Cardio
Derma Clinical Partners Agreement
This
Agreement is made as of July 10, 2008 by and between CardioVascular
BioTherapeutics, Inc., a Delaware corporation (“CVBT”) and ▇▇▇▇ Living Trust and
any individual or entity existing or formed for this Agreement (“Sponsor”)
with reference to the following:
RECITALS
A. CVBT
is a biopharmaceutical company in the process of developing drugs utilizing
formulations of human FGF-1 for cardiovascular diseases characterized by
inadequate blood flow to a tissue or organ.
B. CVBT
has obtained or will soon obtain authorization from the U.S. Food and Drug
Administration (“FDA”) to commence a Phase Ib/II clinical trial for its wound
healing drug candidate CVBT-141B (the “Drug”).
C. Sponsor
wishes to form a limited partnership in order to fund the further research
required to bring the Drug through all or a portion of its Phase Ib/II clinical
trial. The R&D Partnership will be named Cardio
Derma Clinical Partners
(“CDCP”).
D. CVBT
is willing to enter into a contract with the CDCP to conduct and/or manage
the
further research required to bring the Drug through all or a portion of its
Phase Ib/II clinical trial.
AGREEMENT
THEREFORE,
in consideration of the promises and the mutual covenants contained herein
and
for valuable consideration the sufficiency of which is acknowledged, the
parties
agree as follows:
1. Formation
and Funding of the R&D Partnership.
Either directly or through an investment vehicle controlled by Sponsor, on
or
before July 10, 2008, Sponsor agrees to form and act as the general partner
of
CDCP. In that regard, Sponsor agrees to commit up to $1,000,000
USD
(One
Million US Dollars)
to the funding of CDCP and to raise on a best efforts basis up to an additional
$4,000,000 USD
(Four
Million US Dollars)
from sophisticated, accredited investors. Sponsor agrees that, unless the
funding requirement of section 2(a) below is extended by CVBT, all funding
will
be completed by August 15, 2008 with an interim closing on July 25, 2008.
CVBT
will have no responsibility for the formation, management, funding or operation
of CDCP. ▇▇▇▇ Living Trust shall be the main point of contact with whom CVBT
shall work when interacting with CDCP unless Sponsor designates in writing
a
party other than Sponsor.
2. Development
Contract
(a) Investment.
Sponsor agrees that it will cause CDCP to enter into development and licensing
agreements with CVBT, containing customary provisions, for the purpose of
conducting all or a portion of the further research necessary to develop
the
Drug into a marketable product. Sponsor will cause CDCP to commit a minimum
of
$1,000,000
USD
(One
Million US Dollars)
and up to $5,000,000
USD
(Five
Million US Dollars)
toward such research and development effort described in the development
agreement all of which shall be paid to CVBT on or before August 15, 2008
with
an interim closing on July 25, 2008, unless extended by CVBT.
(b) No
Liability If Not Successful.
If development of the Drug is not successful, CVBT will owe nothing to the
Sponsor or CDCP.
Page
1 of
3
(c) Economic
Benefit to the R&D Partnership.
CDCP will receive from CVBT the right to a royalty if revenues or other forms
of
economic benefit are derived from the Drug, and CDCP will receive the right
to
acquire warrants to purchase CVBT’s common stock.
(i)
Royalty.
CDCP shall have and is herby granted irrevocably a right to participate in
all
future revenues of the CVBT wound healing drug, whether from partnering,
licensing or from sales once the Drug is approved by the regulatory authorities.
CDCP shall receive 10% of all monies CVBT collects for the wound healing drug,
until the partnership has received a cumulative total of 10 times the original
contracted sum as defined in the development agreement. Royalty payments will
be
paid from CVBT to CDCP on a quarterly basis as provided for in the development
and/or licensing agreements.
(ii) Warrants.
The partnership CDCP shall also be granted and receive a 5 year warrant to
buy
500,000 shares of CVBT common stock for $1.00 per share for its original one
million dollar clinical contract. For any additional sums above the original
One
Million USD the partnership shall get an additional 5 year warrant for 50,000
common shares with an exercise price of $1.00 for each additional $100,000
USD
contracted for and paid to CVBT before August 15, 2008.
(d)
▇▇▇▇▇▇▇
Put.
Separate from CVBT and as an additional inducement to enter into the development
and licensing agreements, ▇▇. ▇▇▇▇▇▇▇ will provide to each and every partner
of
CDCP, a personal guarantee that ▇▇. ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ will from the
37th
month of their investment, until the 60th
month, if requested, purchase the partner’s investment in the CDCP for their
original capital contribution plus 100%; less any money already paid to the
partner. Once the CDCP pays out to its partners an amount equal to 200% of
the
amount of the development agreement funding, without regard to the source of
the
money, or, the payment by CVBT of 200% of the amount funded in the development
agreement is paid to CDCP, ▇▇. ▇▇▇▇▇▇▇’▇ “Put” automatically
terminates.
3. Ownership
of the Drug and Intellectual Property Rights.
At all times during the course of development pursuant to the development and
licensing agreements and this Agreement, the Drug and all intellectual property
rights related thereto shall be owned by CVBT unless provided otherwise by
the
provisions of the development and/or licensing agreements. Nothing in this
Agreement shall be construed to create any license or transfer any intellectual
property rights to any party.
4. Miscellaneous.
(a) Except
for the development and licensing agreements, the warrants (2(c)(ii)) and the
▇▇▇▇▇▇▇ Put (2(d)) referenced in Section 2 hereof, this Agreement constitutes
the entire agreement between the parties hereto with respect to the subject
matter hereof.
(b) This
Agreement shall be governed by the laws of the State of Nevada, without regard
to its conflicts of law rules with exclusive venue in the state and federal
courts within the District of Nevada.
(c) This
Agreement will terminate automatically and be of no further force or effect
if
(i) CDCP is not formed on or before July 9, 2008 and (ii) the development
agreement referenced in Section 2 hereof has not been entered into by CVBT
and
the Sponsor on behalf of CDCP on or before July 11, 2008.
(d) Sponsor
understands and acknowledges that CVBT is a publicly traded company, and as
such, CVBT will be required to report the terms of this Agreement, and the
development agreement, pursuant to its reporting obligations under the
Securities Exchange Act of 1934, as amended. Sponsor also acknowledges that
CVBT
plans to make a press release about this Agreement and the development
agreement. Copies of both will be provided to the Sponsor.
Page
2 of
3
(e) Time
is of the essence in this Agreement.
(f) This
Agreement may be executed in person or by PDF email file or facsimile and
in one
or more counterparts, all of which together shall constitute one original
document for all legal purposes.
(g) If
any provision of this Agreement is held by a court of competent jurisdiction
to
be unenforceable, then such provision shall be disregarded and the remaining
provisions of this Agreement shall remain in full force and effect.
IN
WITNESS WHEREOF, the parties hereto have executed this Agreement as of the
date
first above written.
| CARDIOVASCULAR BIOTHERAPEUTICS, INC. |
▇▇▇▇
LIVING TRUST
|
|||
|
By
|
/s/
▇▇▇▇▇▇▇ ▇. ▇▇▇▇
|
By
|
/s/
▇▇▇▇▇▇ ▇▇▇▇ ▇▇.
|
|
|
Name
|
▇▇▇▇▇▇▇
▇. ▇▇▇▇
|
Name
|
▇▇▇▇▇▇
▇▇▇▇ ▇▇.
|
||
|
Title
|
Chief Financial Officer |
Title
|
Trustee
|
||
|
(“CVBT”)
|
(“Sponsor”)
|
|
▇▇▇▇▇▇
▇. ▇▇▇▇▇▇▇ AS AN INDIVIDUAL
|
||
|
By
|
/s/
▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
|
|
|
In
his capacity as an individual and being bound hereby
only with respect to Sections 2(d) and 4
|
||
Page
3 of
3