Exhibit 10.33
Product Development Services
Agreement - Second Amendment
This Second Amendment to that certain November
9, 2001 Product Development Services Agreement as amended August 4,
2003 ("Product Development Services Agreement''), is made as of
June 2, 2006 ("Second Amendment"), by and between Biomed Research,
Inc., a Florida corporation ("Biomed”), and MedEnclosure,
L.L.C., a Nevada limited liability company ("Sponsor"). All
capitalized terms used but not otherwise defined in this Second
Amendment shall have the respective meanings ascribed to such terms
in the Product Development Services Agreement, or as used by the
parties in their prior dealings.
Whereas the Product Development Services
Agreement, as amended, addresses development of the Product through
various phases, through and including Phase IV(b);
Whereas the parties desire and hereby mutually
agree to continue development of Phases V and VI on terms and
conditions as set forth herein below;
Whereas the parties have entered into a separate
hourly Services Agreement for services beyond the scope of the
Product Development Services Agreement, or as contemplated by this
"Second Amendment";
Now therefore,
the parties hereby agree as follows:
1) To the
following budget, deliverables and milestone payment schedule for
the further development of Phases V & VI the MedClose VCS
product:
(a) Services
provided beyond the scope of the Product Development Services
Agreement, as amended August 4, 2003, such as Phase IV revisions,
shall be invoiced to the Sponsor according to the Services
Agreement of April 17, 2006, by and between the parties.
(b) Budget
and deliverables for Phases V & VI as attached hereto as
Exhibit A.
(c)
Milestones / payment schedule;
i. Phase V
payments shall be made as follows:
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1.
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Payment of one
third $376,471 is due with the execution of this Second Amendment
by both parties;
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2.
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Payment of one
third $376,471 is due 90 days after execution of this Second
Amendment;
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3.
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Payment of one
third $376,471 is due 180 days after execution of this Second
Amendment. This payment shall be offset by prepayment in the amount
of $25,715.30 made by MedEnclosure to Biomed in connection with
Phase V and other services ("Prepayments").
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4.
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Effective
upon the later to occur of the date that this Amendment is executed
by both parties, and the receipt by MedEnclosure from Biomed of a
written schedule of invoices containing specific charges for the
Prepayments, MedEnclosure and Biomed, do hereby mutually release
each other and their respective stockholders, and representatives
from any known claims of any sort which either party now has or may
ever have against the other, arising prior to the date hereof out
of any matter, directly or indirectly related to (1) the Product
Development Services Agreement, as amended, and (ii) the Services
Agreement of April 17, 2006, among the parties.
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Phase VI
payments shall be made as follows:
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1.
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Payment of one
third [$87,446] is due upon receipt of a written notice from Biomed
that all subjects are enrolled into the MedClose clinical trial as
defined in CL-7000, Rev, B, which shall be incorporated as Exhibit
C to this Agreement when it is provided.
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2.
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Payment of one
third [$87,446] is due when the premarket approval (PMA)
application is submitted to the U.S. Food and Drug Administration
(FDA), as evidenced by confirmation of delivery by Federal Express
or similar third-party courier.
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3.
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Payment of one
third [$87,446] is due when the PMA application is approved by the
FDA.
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(d)
On a monthly basis, by the first of the month, Biomed shall
provide brief status reports concerning the completion of tasks
under Phases V and VI, as set forth in Exhibit A. The brief status
reports shall be provided in electronic form to:
e) Clinical
trial insurance shall be paid for by MedEnclosure and shall name
MedEnclosure as the insured party.
2) The
term "Development Plan" as defined by reference to Exhibit A of the
Product Development Services Plan in section 1.2 therein, is hereby
modified as necessary to comport with the scope of development
services contemplated under this Second Amendment.
3) Section
4.2 of the Product Development Service Agreement regarding
Termination is amended by deleting:
"If this Agreement is terminated by Sponsor
during any phase of the development plan, Biomed shall refund
to Sponsor within thirty (30) days of the effective date of such
termination, a pro-rata portion of the payment with respect to such
phase based on the number days remaining in such phase (determined
with reference to the total number of days accorded to such phase
on Exhibit A)."
"If this Agreement is terminated for cause by
Sponsor during any phase of the Development Plan, Biomed shall
refund to Sponsor within thirty (30) days of the effective date of
such termination, a pro-rata portion of the
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