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 respectivemeanings ascribed to
such terms in the Product Development Services Agreement, or as usedby 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 ascontemplated 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:




1.
            Payment
      of one third $376,471 is due with the execution of this Second Amendment
      by both parties;




2.
            Payment
      of one third $376,471 is due 90 days after execution of this Second
      Amendment;




3.
            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").




4.
            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 respectivestockholders,
      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.









Phase VI
payments shall be made as follows:




1.
            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.




2.
            Payment of one third [$87,446] is
      due when the premarketapproval (PMA) application is
      submitted to the U.S. Food and Drug Administration (FDA), as evidenced by
      confirmation ofdelivery by Federal Express or
      similar third-party courier.




3.
            Payment
      of one third [$87,446] is due when the PMA application is approved by the
      FDA.




(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:




Rod
Shipman


MedEnclosure,
LLC


Sarasota,
FL 34243


rshipman@insights.net




e) Clinical
trial insurance shall be paid for by MedEnclosure and shall name MedEnclosure
asthe 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 developmentplan, 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 thetotal
number of days accorded to such phase on Exhibit A)."




and
substituting:




"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 payment with respect to such
phase based on the number of days remaining in such phase (determined with reference tothetotal number of days
accorded to such phase on Exhibit A). If this Agreement is terminated
without cause by Sponsor during any phase of the Development Plan, in
addition to any other remedies available to Biomed hereunder, Sponsor shall be
obligated to pay out the balance of its obligations hereunder including payment
of all remaining installments associated with completion of the project as
defined in the Product Development Services Agreement, and as set forth at
Sections 2(b) and (a) of the Second Amendment.











This
Agreement may be terminated for cause by a party if the other party breaches any
material representation, warranty, or obligation provided hereunder. This
Agreement may be terminated for cause by Sponsor in the event that the FDA
terminates the associated investigational device exemption (IDE) or otherwise
does not permit the Study to proceed, or Sponsor terminates the Study in order
to achieve compliance with applicable FDA laws and/or regulatory
requirements."




4) In the
eventthat it becomes
necessary to revise, modify or change the investigational Plan, CL-7000, Rev. B,
i.e., requiring the need for a Rev. C, or the assumptions regarding Phases V and
VI change, the parties agree that such change will constitute the conditions
necessary to execute a Third Amendment to the Product Development Services
Agreement, which both parties shall negotiate in good faith.




IN
WITNESS WHEREOF, the parties hereto have executed this Second Amendment to the
Product Development Services Agreement by proper persons thereunto duly
authorized:






MedEnclosure,
      L.L.C
                
                By: Rod A.
      Shipman
                Rod
      A. Shipman, Managing Member,
                President
      and CEO
              Biomed
      Research, Inc.
                
                By: /s/ Michael
      Dayton
                Michael
      Dayton, PresidentDate:  June
      2, 2006
              Date:  6-02-06










Exhibit
A
 Second
Amendment - Product Development Services Agreement
 Phase V -
Human Clinical Trial / Phase VI- MarketingApproval
 Phase V – Human Clinical
Trials Research
 Assumptions
 Investigational
Plan CL-7000, Rev. B
 3
clinical sites
 385-400
subjects ("run-in" + randomized)
 15 Case
Report Forms
 30 day
subject follow-up
 2 month
set-up
 8 month
subject enrollment
 3 month
data retrieval and clean-up
 12 months
for clinical phase
  INCLUDED
TASKS
 
 Clinical
trial
management               
 TOTAL CLINICAL TRIAL MANAGEMENT $ 645,870.00
 design /
print CRF's x 15
 informed
consent x 3-6
 investigator
brochure
 provide
site CRF binders
 train
sitesCRF /
binders
 source
document worksheets
 identify/recruit
investigators
 negotiate
site reimbursements
 conduct
investigator meetings
 select /
obtain IRS approvals
 deliver
investigational device to sites
 manage
control of Investigational units
 train
Investigators MedClose
 train
scrub / circulating nurses Tisseel
 clinical
monitoring of sites / data
 resolve
CRF data queries
 monitors
attend project mtgs
 weekly
subject enrollment reports
 maintain
central study files
 recruit
/ manage MedicalMonitor
 recruit /manage Clinical Events
Committeemembers
 coordinate
mtgs of Medical Monitor / investigators
 coordinate
mtgs of Clinical Events Committee
 prepare /
submit required study reports to FDA
 monthly
status reports to MedEnclosure
 
 Clinical
data management TOTAL CLINICAL DATA MANAGEMENT $ 288,934.00
 design /
develop database/ entry screens
 program
allowable data rules / flagging
 test database /edit
check
 CRF
review/ query resolution
 CRF entry
validation
 QA data
audit / report
   
  EXHIBIT
A
 Second
Amendment - Product Development Services Agreement
 Phase V -
Human Clinical Trial / Phase VI - Marketing Approval
  INCLUDED
TASKS
 
 U.S.
Premarket Approval (PMA)
Application                   
TOTAL PMA APPLICATION $ 202,338.00
 PMA
summary:
 indications
for use.
 combination
product description; ingredients, components, modes of action.
 alternative
practices and procedures.
 marketing
history.
 summary
of non clinical laboratory studies.
 summary
of human clinical investigation.
 conclusions
drawn from studies.
 methods
and controls for manufacturing, par:treeing and storage.
 reference
to applicable performance standards; statement of conformance,
 detailed
analysis of non clinical studies; microbiological, toxicological,
biocompatibility, sterility, shelf life and animal studies w/statement
of compliance to GLP regulations.
 detailed
analysis of human clinical studies; protocol, investigators, subjects. AE's,
device failures, complaints, results of statistical analyses, contraindications,
precautions, etc.
 bibliography,
copies of pertinent published reports.
 proposed
packaging and labeling.
 environmental
assessment.
 anancial
disclosure and certification,
 reference
to applicable master files, i.a., Tisseel biologics application
(BLA).
 update of
pending application w/ new safety and effectiveness information, where
applicable,
 negotiate
final labeing; Instructions for use, patient information booklet, products
labels.
 prepare
summary of safety and effectiveness (SS&E) document for public release by
FDA. monthly status reports to MedEnclosure
  
 PMA
Application Amendments
 amendments to pending PMA
application w/revised and/or additional Information, where necessary,assumptions are
the same as those above, i.e.. human data derived from CL-7000, Rev. 13trial.
 
  TOTAL
PROJECT • PHASE VI  $262, 338.00
 Direct
pass through of actual expenses:
  1.
                        Any
      governmental fees, such as user fees, required for the submission of
      marketing approval applications, and any amendments or supplements
      thereto, shall be expenses passed through directly to
      MedEnclosure
 2.
                        Any
      changes to the assumptions or task list above will require a Change
      Order approved by both Biomed MedEnclosure subject to Section 4
      of the foregoing Second Amendment.
  Marketing
approval outside the United States:
 1.
                          Bycontracting the U.S. PMAapplication through Biomed, MedEnclosure is entitled to significant
      discounts for additional marketing approval applications in Canada and
      EuropeanUnion countries.
 2.
                          Marketing
      applications in Canada and EU countries shall be negotiated independent of
      this agreement.




EXHIBIT
A
  Second
Amendment - Product Development Services Agreement
  Phase V -
Human Clinical Trial / Phase VI - Marketing Approval
   Biostatistical     
TOTAL BIOSTATISTICAL MANAGEMENT     $214,809.00
 develop
randornization scheme
 implement
randomization
 create
statistical analysis table shells
 create statistical listingshells
 SASprogramming
 statistical
reports
 data
transfer
 statistics
QC review & OA report
 statistics teleconferences
/ consults
  
  TOTAL
PROJECT - PHASE V $1,129,493.00
  Direct
pass-through of actual expense:
  1.
                AR expenses incurred for travel
      and other expenses incurred in performance of services by
      Biomed, BioStat,
      Medical Monitor, and Clinical Events Cornrnittee, as approved by
      Biomed.
  2.
              Any
      expenses approved by Biomed incurred for copying, printing and delivery of
      project documents, i.e., case report
forms.
  3.
              Investigational
      site per patient fees, femoral ultrasound, ABA,
  etc
  4.
              Institutional
      Review Board (RIB) fees
  5.
                Honorarium
      and fees for services performed by Medical Monitor and Clinical Events
      Committee (CEO)
  6.
              Any
      governmental fees approved by Biomed associated with submission of
      human study applications shall be passed through directly to
      MedEnclosure
  7.
              Billing
      to MedEnclosure will occur monthly for pass through expenses pre-paid by
      Biomed, along with receipts of actual expenses.Payment will be
      made within 30 days of the receipt of the invoice in electronic form by
      MedEnclosure, or a finance charge will be issued for all outstanding
      balances (annualized rate of 12%).
  8.
              Any
      changes to the assumptions ortask list above
      will require a Change Order approved by both Biomed and MedEnclosure
      subject to Section 4 of the foregoing SecondAmendment.