Document:

Exhibit
10.32

 

Confidential
Materials omitted and filed separately with the 

Securities and Exchange Commission. 
Asterisks denote omissions.

 

COMMERCIAL
SUPPLY AND 

PROCESS VALIDATION AGREEMENT

 

THIS COMMERCIAL SUPPLY
AGREEMENT (the “Agreement”) is entered into as of this 6th day of December,
1999 by and between TRANSKARYOTIC THERAPIES, INC.,(“TKT”), a Delaware
corporation having an address at 195 Albany Street, Cambridge, MA 02139, and
CHESAPEAKE BIOLOGICAL LABORATORIES, INC., a Maryland corporation having an
address at 1111 South Paca Street, Baltimore, MD 21230 (“CBL”), with respect to
the following:

 

RECITALS

 

A.            TKT
is a development-stage biotechnology company active in the research and
development of drug products.

 

B.                                     CBL
is in the business of formulating, sterile filling, and packaging liquid
injectable drug products and medical devices.

 

C.                                     TKT
and CBL desire to enter into this Agreement in order to establish the terms and
conditions under which CBL will formulate, fill, and package Product for clinical
trial and consistency batches for FDA approval and, following FDA approval of
CBL as a formulation, fill-finish site for the Product, for commercial sale.

 

D.                                    Both
parties contemplate that additional TKT products may be included under this
Agreement, as amendments, by mutual written consent of the parties.

 

AGREEMENT

 

NOW THEREFORE, in
consideration of the premises and the mutual promises and covenants contained
in this Agreement, and for other good and valuable consideration, the receipt
and sufficiency of which is hereby acknowledged, the parties hereto agree as
follows:

 

ARTICLE
I

DEFINITIONS

 

All references to
particular Exhibits and Sections shall mean the Exhibits to, and Sections of,
this Agreement, unless otherwise specified. 
For the purposes of this Agreement and the Exhibits hereto, the
following words and phrases shall have the following meanings:

 

1

 

1.01        “Active Ingredient”
shall mean active pharmaceutical ingredient (API) of alpha-Galactosidase A as
described in Exhibit A.

 

1.02        “Affiliate” shall
mean any corporation, firm, partnership or other entity, whether de jure
or de facto, which directly or indirectly owns, is owned by or is under
common ownership with a party to this Agreement to the extent of at least fifty
percent (50%) of the equity having the power to vote on or direct the affairs
of the entity and any person, firm, partnership, corporation or other entity
actually controlled by, controlling or under common control of a party to this
Agreement.

 

1.03        “Agreement” shall
mean this Commercial Supply Agreement.

 

1.04        “Batch or Lot” shall
mean a single run of Product processed by a single execution of the
instructions specified in the Batch Production and Control Record within the
meaning of 21 CFR part 210.3(b)(2) and/or within the meaning of 21 CFR part
600.3(x), or its successor as in effect from time to time.

 

1.05        “Batch Production and Control Record” or
“Batch Record” shall mean the set of detailed
processing instructions which are to be followed by CBL to process one batch of
Product within the meaning of 21 CFR part 211.188, or its successor as in
effect from time to time.

 

1.06        “FDA” shall mean the
United States Food and Drug Administration.

 

1.07        “Formulated Bulk”
shall mean formulated Active Ingredient as described in Exhibit A.

 

1.08        “Good Manufacturing Practices”
or the letters “GMP” or “cGMP” shall mean the writings of the Code
of Federal Regulations, Part 21, Section 210 and Section 211, or other sections
so designated by the title “Good Manufacturing Practices” promulgated under the
Federal Food, Drug and Cosmetic Act, as in effect from time to time.

 

1.09        “Master Production and Control Record” or
“Master Batch Record” shall mean a written description
of the procedure to be followed for processing a batch of Product including but
not limited to a complete list of all active and inactive ingredients,
components, weights and measures, descriptions of drug product containers,
closures, packaging materials, and labeling and complete specifications for
each, within the meaning of 21 CFR part 211.186, or its successor as in effect
from time to time.

 

1.10        “Materials” shall
mean all inactive ingredients, vials, stoppers, seals, labels, inserts, folding
cartons and/or shipping cartons as are otherwise necessary to be utilized in
the Processing and to meet the Specifications, but excluding Active Ingredient.

 

1.11        “Processing” shall
mean processing Product in accordance with the Master Batch Record for the
Product.  “Processed” and “Process”
shall have comparable meanings.

 

1.12        “Product(s)” shall
mean the liquid product(s) covered by this Agreement and processed as
contemplated hereby.

 

2

 

1.13        “Project Summary”
shall mean those documents attached to this Agreement as Exhibit A, which
provide specific details about the Product to be processed for TKT by CBL.

 

1.14        “Specifications”
shall mean the acceptance criteria for the Product as set forth in the Master
Batch Record.

 

1.15        “USP” shall mean the
United States Pharmacopeia, Vol.  23, or
any subsequent addition thereof.

 

ARTICLE
II

SUPPLY
AND PROCESSING OF MATERIALS

 

2.01        Processing.  Subject to the terms and conditions of this
Agreement, CBL agrees that it shall formulate, fill, and package the Product at
its Camden parenteral filling facility in Baltimore, MD validated in accordance
with FDA regulations, and shall process the Product in accordance with cGMP’s,
including without limitation adherence to appropriate quality assurance and quality
control practices.  CBL will permit TKT
to review all written internal CBL quality assurance and quality control
practices.  If TKT requests a change in
CBL’s practices and the parties agree that such a change is appropriate to
comply with FDA regulations then CBL will act in good faith to implement the
requested change.  CBL further agrees
that it will use reasonable and customary efforts to comply with regulations of
foreign authorities applicable to the processing of Product by CBL.  The product cannot be processed at another
facility without the written authorization of TKT.

 

2.02        Master Production Record.  Subject to the terms and conditions of this
Agreement, CBL agrees to process the Product in accordance with a Master
Production and Control Record approved in writing by TKT.  CBL further agrees that any substantive
changes to the Master Production and Control Record and the process must
receive written approval of TKT prior to implementation, provided, however,
that any approvals to be delivered by TKT shall not be unreasonably withheld
and the parties shall cooperate and act reasonably and in good faith in
connection with their respective activities under this Section.  CBL will permit TKT to review all information
in Master Production Records pertaining to individual product lots as well as,
raw material test results and the results of environmental monitoring prior to
product release by CBL but after CBL’s completion of its internal review of the
batch record.  CBL will release the
batch record within [**] of receiving TKT’s comments and proposed changes.

 

2.03        TKT Supplied Materials.  TKT, at its expense, shall deliver
sufficient quantities of Active Ingredient, any Material, or production
equipment indicated on Exhibit A hereto as to be provided by TKT, to
CBL’s plant at Baltimore, Maryland prior to the scheduled date of Processing as
indicated in Exhibit A, unless otherwise agreed to by CBL.  All such items supplied by TKT for purposes
hereof shall meet the applicable specifications therefor as set forth on Exhibit
A and the Master Production Record. 
All items so delivered shall remain the property of TKT.

 

2.04        CBL Supplied Materials.  CBL will be responsible for supplying
sufficient quantities of any Materials indicated on Exhibit A hereto as
provided by CBL, insofar as required to permit CBL to complete the Processing
and delivery of Product in accordance with

 

3

 

the terms hereof.  All such
items purchased by CBL for purposes hereof shall meet the applicable
Specifications therefor as set forth on Exhibit A and the Master
Production and Control Record.

 

2.05        Labeling Specifications.  TKT shall be responsible for furnishing to
CBL appropriate specifications, reasonably acceptable to CBL, for the labeling
and packaging (including package inserts) to be used on or in connection with
the Processing of Product which is to bear TKT labels or other identification,
and any necessary artwork and engineering drawings related thereto.  Insofar as required of CBL pursuant to Exhibit
A hereto, CBL will label and package Product in accordance with such
specifications.  CBL shall not affix any
other labeling to the Product, except with the prior written approval of TKT.

 

2.06        Stability Testing.  TKT shall be responsible for all requisite
stability testing of the Product.

 

ARTICLE
III

PROCESS
VALIDATION

 

3.01        Process Validation.  An outline for validation of the
formulation, filling, and packaging of the Product at CBL’s facilities is
attached hereto as Exhibit B.  In
accepting its obligations under the terms of this Agreement, developing the
cost in Exhibit C, and the event and time schedule in Exhibit D,
CBL has relied upon the accuracy, completeness, and correctness of the data and
information provided by TKT and the understanding that the Product can be
processed in a stable form in accordance with typical and standard
pharmaceutical production practices. 
CBL will proceed with reasonable promptness to perform its obligations
hereunder, but the parties acknowledge that such process validation is a
demanding effort and unanticipated events beyond the control of the parties may
change the event and time schedule; and, thus, the completion date of CBL’s
performance hereunder cannot be predicted with any meaningful degree of
certainty.  CBL agrees to allow TKT to
approve product related validation protocols prior to execution by CBL.

 

3.02        CBL Responsibilities.  CBL shall provide reasonable assistance to
TKT in its efforts to obtain and maintain all necessary regulatory approvals
and permits relating to the production of Product at CBL facilities.  Accordingly, insofar as relating to Product
and CBL’s processing thereof, CBL shall permit TKT or its designees
typical and customary access to CBL’s facility, other than the filling, and
packaging areas, during the formulation and filling of Product and, upon
reasonable notice and during reasonable business hours and so long as TKT does
not interfere with CBL’s day to day operations (i) to inspect CBL’s processing
facilities, (ii) to review manufacturing and quality control records relative
to production by CBL of the Product, prior to the disposition of the Product
(iii) to audit CBL’s production efforts in respect of Product for compliance
with FDA requirements, (iv) to review CBL’s facility master file, any
correspondence, reports, or other documents from CBL to the FDA, or to any
applicable foreign regulatory authority, or from the FDA, or from any
applicable foreign regulatory authority, to CBL, related to the Product and/or
the facility as it effects the Product, (v) to approve all Product related
variances which occur during manufacture or storage of the Product, including
approval of label text after receipt of labels and prior to application, and
(vi) CBL will inform TKT as quickly as possible regarding facility related
variances and will permit TKT onsite access to all

 

4

 

facility related variances and information for review and those which
in CBL’s judgement may affect the Product will be reviewed with TKT prior to
implementation of corrective action.

 

3.03        TKT Responsibilities.  TKT will be responsible for obtaining all
Federal and International regulatory approvals or permits necessary for the
production, processing, distribution, use, and sale of the Product.  Additionally, TKT will be responsible for
all other regulatory requirements which are not specifically assigned to CBL in
the Project Summary, including the payment of any FDA user fees or other fees
associated with the review and approval to market the Product imposed by any
regulatory agency.  TKT agrees to supply
CBL with any documents, information, and/or data specified as TKT
responsibility in the Project Summary in a timely manner so as not to impede
CBL’s ability to comply with its obligations hereunder.

 

ARTICLE
IV

ORDERS,
PRICE, & TERMS OF PAYMENT

 

4.01        Purchase Orders.  Unless otherwise specified, TKT shall submit
a purchase order to CBL at least [**] prior to the requested delivery date for
the Product set forth in such purchase order. 
CBL shall accept such purchase orders from TKT and shall notify TKT of
the processing date.  CBL must receive
from TKT any Active Ingredient and Materials to be supplied by TKT for use in
Processing at least [**] prior to the processing date.

 

4.02        Forecast.  TKT shall provide CBL in writing with
rolling [**] non-binding, good faith forecasts of TKT’s annual requirements for
Product, in quarterly periods.  Such
forecasting shall be updated in writing quarterly.

 

4.03        Cancellation and Rescheduling.  TKT may cancel or postpone a purchase order
for Product in accordance with CBL’s Cancellation and Postponement Policy as
set forth in Exhibit E.

 

4.04        Price.  The price to be paid by TKT to CBL during
the term of this Agreement for any projects or validations, and each Batch of
Product, shall be as specified in Exhibit C.  All prices are FOB CBL’s facility in Baltimore, Maryland.  Payment of all FDA fees specific to the
Product will be the responsibility of TKT. 
CBL’s price does not include any other testing, studies, Product
specific validations not presently required, or other activities, which TKT may
deem necessary but which are not required of CBL by this Agreement.

 

4.05        Invoices.  The invoice for the total amount shall be
payable by TKT to CBL within [**] days of the date of invoice, date of shipment
or date of issuance of the Certificate of Conformance referred to in Section
5.03, whichever is latest; provided that if TKT requests or causes CBL to hold
a Batch of Product for more than [**] days, TKT will be invoiced and the [**]
day payment terms would commence on the invoice date.

 

ARTICLE
V

SHIPMENTS,
INSPECTION, & ACCEPTANCE

 

5.01        Shipments.  CBL shall ship or caused to be shipped at
TKT’s expense the Product to TKT to such destination(s) as designated by TKT
except that CBL shall not be required to

 

5

 

ship Product to any clinical trial site.  CBL’s delivery of Product to a common carrier or licensed trucker
approved by TKT shall constitute delivery to TKT, and TKT shall bear all risk
of loss, delay or damage in transit. 
CBL agrees to provide reasonable support to assist TKT to pursue any
claims it may have against carriers.

 

5.02        Inventory in Quarantine.  TKT may request in writing that CBL ship
Product from CBL’s inventory in quarantine, prior to the issuance by CBL’s
Quality Assurance Department of the appropriate release; however, TKT agrees
not to introduce any of the Product into interstate commerce until the receipt
of proper quality control release by CBL applicable to the Product.  Such a request will result in an invoice
being sent as of the shipping date and commencement upon invoice delivery of
the [**] day payment terms.  TKT shall
indemnify and hold CBL harmless from any and all losses, damages, claims, or
costs, including reasonable attorney’s fees, which CBL may suffer or incur as a
result of and arising out of the shipment or use of the Product prior to its
release by CBL’s Quality Assurance Department.

 

5.03        Certificate of Conformance.  Upon completion of filling, inspection,
packaging, and quality assurance review, CBL shall promptly provide TKT a
Certificate of Conformance for each Batch of Product shipped, certifying that
the Product has met all Specifications set forth in this Agreement.

 

5.04        Inspection.  TKT shall inspect all shipments of Product
received from CBL for proper labeling, packaging and count within [**]days of
actual receipt of shipment at its designated receiving facility.  However, any such inspection shall not
relieve CBL of its obligation and warranties under this Agreement.  If any portion of the Product received fails
to conform with any applicable Specification, TKT may, subject to the terms of
Section 5.05 hereof, reject the same within [**] days of the latter date of
actual receipt of (i) the Product; or (ii) a Certificate of Conformance.

 

5.05        Rejection.  In any case where TKT expects to reject or
otherwise make a claim against CBL with respect to damaged or otherwise
nonconforming Product, TKT shall notify CBL of such expected rejection and CBL
shall be offered a reasonable opportunity to offer proof or evidence as to why
such Product should not be rejected and to inspect and/or test such
Product.  In the event of any dispute as
to whether the Product may be rightfully rejected by TKT, such Product shall be
tested for conformance with the applicable Specifications by an independent
testing organization mutually acceptable to both parties which analysis shall
be binding on TKT and CBL solely for the purpose of determining whether such
Product may be rightfully rejected or not. 
TKT shall not under any circumstances dispose of any Product claimed by
TKT or determined by independent testing organization to be damaged or
nonconforming, without CBL’s prior written consent.  All or part of any shipment of Product determined to have been
rightfully rejected by TKT shall be held by TKT for disposition by CBL, at
CBL’s expense.

 

ARTICLE
VI

REPRESENTATIONS
& WARRANTIES

 

6.01        Warranties by CBL.  CBL warrants that all Product delivered to
TKT (or shipped to a third party at the direction of TKT) under this Agreement
shall at the time of

 

6

 

delivery, be free of defects in material and workmanship; meet the
Specifications (except in the case of Product delivered in quarantine pursuant
to Section 5.02, in which case upon release from quarantine); and have been
processed and maintained in conformance with cGMPs and other applicable FDA
regulations.

 

6.02        Warranties by TKT.  TKT warrants that its storage, labeling
(including, without limitation any labeling, packaging and insert
specifications supplied by TKT pursuant to or as contemplated by Section 2.05
hereof), distribution, use, and sale of Product complies and will comply with
all applicable Federal, state and local laws, rules and regulations and will be
undertaken in a safe and responsible manner. 
If the Product is intended for distribution, use, and/or sale outside of
the United States, TKT further warrants that all necessary US export licenses
are in place or will be in place at the time of export and that the export,
distribution and/or sale comply with all laws, rules and regulations of the
country where the Product will be used. 
TKT represents and warrants to CBL that TKT is not aware that Product,
or the processing or distribution thereof, will violate the intellectual
property rights of any third party, and that TKT is not engaged in the theft or
misuse of any third party’s trade secret information regarding the processing
or use or distribution of Product, nor does TKT have notice of any claim of a
third party regarding any such theft or misuse.

 

6.03        Limitation on Warranties.  The warranties set forth in this Article VI
are expressly stated and in lieu of and exclude, and the parties do expressly
disclaim, all other warranties expressed or implied, arising by operation of
law or otherwise, including, on the part of CBL, any implied warranties of
fitness for a particular purpose and any representation or warranty as to the
suitability or efficacy of Product.

 

ARTICLE
VII

INDEMNITY,
LIMITATION ON LIABILITY, & RECALLS

 

7.01        Indemnification by CBL.  CBL shall defend, indemnify, and hold TKT
harmless from and against any and all claims, liability, damage, loss, cost and
expenses (including reasonable attorney’s fees) arising from any third party
claims made or brought, or any proceedings of any sort initiated against TKT
which (i) arise out of CBL’s breach of any obligations or warranty, or negligence
by CBL under this Agreement, or arise out of or are based upon any claim of
violation by CBL of any patent, trade secret or other intellectual property
rights of any person or entity, subject, however, in each case to the
limitations set forth in Section 7.05 below.

 

7.02        Indemnification by TKT.  TKT will defend, indemnify, and hold CBL
harmless from and against any and all claims, liability, damage, loss, cost and
expenses (including reasonable attorney’s fees) resulting from any third party
claims made or brought against, or proceedings of any sort initiated against
CBL which (i) arise out of TKT’s breach of any obligation, warranty or
negligence by TKT under this Agreement, (ii) arise out of the promotion,
distribution, sale or use by TKT or any third party of Product, including
without limitation any product liability claim (except to the extent CBL is at
fault or has failed to deliver or supply Product in accordance with the
Specifications), or (iii) arise out of any or are based upon any claim of violation
by TKT of any, patent, trade secret or other intellectual property rights of
any person or entity, subject, however, in each case to the limitation set
forth in Section 7.05 below.

 

7

 

7.03        Conditions.  Each party’s indemnity obligations (the
“Indemnifying Party”) under Sections 7.01 and 7.02 are conditioned upon the
other party (the “Indemnified Party”) promptly notifying the Indemnifying Party
of any such claim or proceeding in writing, tendering to the Indemnifying Party
the opportunity to defend or settle such a claim or proceeding at its expense
and cooperating with the Indemnifying Party (at the expense of the Indemnifying
Party) in defending or settling any such claim or proceeding.  The indemnifying party should not enter into
any settlement which imposes liability on the indemnified party without the
indemnified party’s prior written consent not unreasonably withheld.

 

7.04        Recall.  Subject to the limitations set forth in
Section 7.05 below, CBL agrees to indemnify TKT against the reasonable and
necessary actual costs of managing and controlling any recall of Product,
provided that such recall is attributable to a breach by CBL of any of the
warranties provided herein, that CBL is given an adequate opportunity to
participate in any and all discussions with the FDA or otherwise concerning the
proposed recall and unless otherwise specified by the FDA, the manner and
method of a voluntary recall shall have been reasonably approved by CBL.  CBL shall not be obligated under this
Section 7.04 to indemnify TKT if the recall is due to misbranding of the
Product by TKT or is due to any other act or omission of TKT or any other third
party not controlled by CBL.

 

7.05        Limitation on Liability.  Anything herein to the contrary
notwithstanding:

 

(i)            Neither party hereto shall be liable
to the other, or the successors or permitted assigns of the other, or any other
person, for any loss of profits, loss of business or interruption of business,
or for any indirect, incidental, special or consequential damages, costs,
losses or expenses, suffered or incurred under this Agreement or otherwise,
even if advised of the possibility of such loss; and

 

(ii)           CBL’s liability for the replacement
or for the cost or value of any Active Ingredient, Materials, or production
equipment supplied to CBL hereunder by TKT, including but not limited to any
Active Ingredient, Materials, or production equipment lost or damaged or
incorporated into any single rejected or nonconforming Batch of Product, shall
be limited to the actual value thereof, up to the extent of CBL’s insurance
coverage for property of others which has a dollar value of $2.0 (two) million
dollars in the aggregate.  TKT will be
responsible to prove value of any claimed loss to CBL’s insurance carrier for
losses covered by CBL’s insurance policy. 
The parties hereto agree that the limitation on liability provided for
under the terms of this Section 7.05, excludes product liability claims and is
an integral part of the agreement of the parties as evidenced by this Agreement
and that the parties are entering into this Agreement in reliance upon the
terms and provisions of this Section 7.05, and that, but for such terms and
provisions, the parties would not be entering into this Agreement.

 

(iii)          Promptly, following the execution of
this Agreement, CBL shall furnish to TKT a certificate of insurance signed by
an authorized representative of CBL’s underwriter evidencing the insurance
coverage required by this Agreement and providing for at least [**] prior
written notice to TKT of any cancellation, termination, material change or
reduction of such insurance coverage.

 

8

 

ARTICLE
VIII

REGULATORY

 

8.01        TKT Responsibilities.  TKT will be responsible for obtaining and
maintaining all necessary regulatory approvals for the distribution and sale of
Product.  Additionally, TKT will be
responsible for all other regulatory requirements which are not specifically
assigned to CBL in this Agreement, including the payment of any FDA user fees
or other fees associated with the review and approval to market the Product
imposed by any regulatory agency.  TKT
will be responsible for maintaining claim files and for submitting appropriate
reports to the FDA and other similar foreign regulatory agencies.  TKT will be further responsible for promptly
notifying CBL of all communications from the FDA or other regulatory agencies,
which may impact or change the production and/or testing of the Product as
performed by CBL.  TKT will notify CBL
of any consumer complaints concerning Product, which might reasonably be
attributed to CBL’s obligations and warrants, within seven (7) days of receipt
by TKT of any such complaints.  All such
information disclosed to CBL shall be considered confidential information under
Section 9 below.

 

8.02        CBL Responsibility.  So long and insofar as necessary to permit
it to perform its obligation hereunder, CBL shall maintain its Annual
Registration of Drug Establishment (form FDA 2656e) and its Annual Registration
of Device Establishment (form FDA 2891a) granted by the FDA updated and in good
order and will make the license and copies of all related documents available
to TKT and its designees for inspection, upon reasonable request.  CBL shall file and maintain a facility Master
File as required by the FDA and maintain Product complaint files pursuant to
applicable federal regulations as covered by CBL’s Standard Operating Procedure
#3075.  CBL will be further responsible
for promptly notifying TKT of all communications from the FDA or other
regulatory agencies, which may impact or change the production and/or testing
of the Product as performed by CBL.

 

8.03        CBL Assistance with Filing.  CBL will provide to TKT, at no additional
cost, copies, electronic formatted disks, of all documents, in CBL’s standard
format, for the manufacturing and control of Product at CBL’s facility, in
support of TKT’s regulatory filings for approval to market Product.  Any additional support, beyond the documents
above, requested by TKT will be charged at CBL’s standard labor rates.

 

8.04        Master File.  CBL shall maintain one or more facility
master files at the FDA and agrees to provide TKT with any requisite letters
authorizing the FDA access to CBL’s facility master file in conjunction with
regulatory review of CBL’s production of Product as set forth in this
Agreement.

 

ARTICLE
IX

CONFIDENTIALITY

 

9.01        Confidentiality.  Each party shall forever maintain in
confidence all information and materials disclosed by the other party and
marked as confidential or which the other party knows or has reason to know are
or contain trade secrets or other proprietary information of the other,
including without limitation the Specifications, Master Batch and Control
Record, Batch Production and Control Record, and other information relating to
the Product (all such

 

9

 

information being “Confidential Information”), and shall not use such
trade secrets or proprietary information for any purpose except as permitted by
this Agreement or disclose them to anyone other than those of its employees,
consultants, agents or subcontractors as are necessary in connection with such
party’s activities as contemplated in this Agreement.  Each party shall be responsible for ensuring compliance with
these obligations by such party’s employees, consultants, agents and
subcontractors.  Each party shall take
precautions at least as strong as those which it takes to protect its own most
valuable trade secrets or proprietary information to ensure that its employees,
consultants, agents and subcontractors do not disclose or make any unauthorized
use of trade secrets or proprietary information of the other party.  Each party shall notify the other promptly
upon discovery of any unauthorized use or disclosure of the other’s trade
secrets or proprietary information.

 

9.02        Exceptions.  The foregoing restrictions on use and
disclosure shall not apply to any TKT Confidential Information or CBL
Confidential Information that:

 

(i)            was know to the receiving party
prior to its disclosure to the receiving party by the disclosing party as
evidenced by written documents predating the receiving party’s receipt of such
Information; or

 

(ii)           is public knowledge at the time of
its disclosure to the receiving party or became public knowledge after its
disclosure to the receiving party through no act or omission or on its behalf;
or

 

(iii)          is lawfully disclosed or made
available to the receiving party by a third party having no direct or indirect
obligation to the disclosing party to maintain the confidentiality of such
Information; or

 

(iv)          is independently developed by the
receiving party without the aid or benefit of Information disclosed to the
receiving party by the disclosing party.

 

Information may be disclosed by the receiving party
pursuant to a subpoena lawfully issued by a court or governmental agency
provided that the receiving party notifies the disclosing party immediately
upon receipt of any such subpoena.

 

ARTICLE
X

TERM AND
TERMINATION

 

10.01      Term.  Unless terminated in accordance with the
provisions of Section 10.02, the term of this Agreement shall commence on the
date hereof and shall continue until the second (2) yearly anniversary
of the date of FDA approval of CBL as a processor of the Product.  In the event TKT has not received FDA
approval for CBL to process the Product for commercial sale and distribution
prior to December 31, 2000 or has not placed binding purchase orders with CBL
pursuant to the terms hereof, within 180 days following such approval, this
Agreement shall be terminable by CBL upon delivery to TKT by CBL of written
notice of termination.  The term of this
Agreement may be extended by mutual written consent of both parties.

 

10.02      Termination.  This Agreement may be terminated by either
party, in the event that the other party (a) files or has filed against it a
petition under the Bankruptcy Act, makes an

 

10

 

assignment for the benefit of creditors, has a receiver appointed for
it or a substantial part of its assets, or otherwise takes advantage of any
statute or law designed for relief of debtors or (b) fails to perform or
otherwise breaches any of its obligations hereunder, if, following the giving
of notice by the terminating party of its intent to terminate and stating the
grounds therefor, the party receiving such notice shall not have cured the
failure or breach within thirty (30) days. 
In no event, however, shall such notice or intention to terminate be
deemed to waive any rights to damages or any other remedy which the party
giving notice of breach may have as a consequence of such failure or breach.

 

10.03      Obligations and Duties Upon Termination or
Expiration.  If
this Agreement expires or is terminated pursuant to Section 10.02, both parties
shall be released from all obligations and duties imposed or assumed hereunder
to the extent so terminated, except as expressly provided to the contrary in
this Agreement.  Upon termination, both parties
shall cease any further use of, and promptly return any, confidential
information disclosed to the receiving party by the other party.  Termination of this Agreement, for whatever
reason, shall not affect the obligation of either party to make any payments
for which it is liable prior to or upon such termination.  Upon termination of this Agreement, TKT
shall purchase from CBL, at CBL’s cost, any Materials purchased for the Product
which CBL has reasonably purchased or ordered (which order cannot be canceled)
based upon TKT’s forecast.  CBL shall
immediately ship such materials to TKT in accordance with TKT’s instructions,
provided that TKT has given reasonable assurance of payment for such items.

 

ARTICLE
XI

MISCELLANEOUS

 

11.01      Exclusive Rights.  TKT and its Affiliates will purchase [**]%
of their annual worldwide requirements for the Product exclusively from CBL
pursuant to the terms hereof each year and for so long as this Agreement
remains in effect.  TKT and its
Affiliates will be relieved of this obligation in any year, in the event that
failure to purchase [**]% of their annual worldwide requirements is due to
either CBL’s (i) failure to accept a valid purchase order, (ii) late delivery
of Product, or (iii) delivery of Product not meeting the Specifications.

 

11.02      Independent Contractor.  CBL shall at all times during the term of
this Agreement be an independent contractor, maintaining sole and exclusive
control over its personnel and operation. 
It is understood that all work performed by CBL shall meet
specifications set forth in this Agreement, and the detailed manner and method
of doing the same shall be under the control of CBL.  At no time will either CBL or TKT hold itself out to be the
agent, employee, lessee, sublessee, partner, or joint venturer of the other,
and it is further understood and agreed between the parties that the full and
exclusive relationship between them is that of an independent contractor.  Nothing in this Agreement shall be construed
to create any agency, employment, partnership, joint venture or similar
relationship between the parties other than that of an independent
contractor.  Neither party shall have
any right or authority whatsoever to incur any liability or obligation (express
or implied) or otherwise act in any manner in the name or on the behalf of the
other, or to make any promise, warranty or representation binding on the
other.  CBL and TKT agree not to use or
refer to the other without prior written permission, in any public statements,
whether oral or written, related to this Agreement.  Furthermore, CBL and TKT both agree not to employ or solicit for
employment or

 

11

 

as an independent contractor any employee of either party during the
term of this Agreement and for a period of two (2) years thereafter.

 

11.03      Insurance; Liability to Third Persons.  CBL and TKT, each at their own expense,
shall obtain and thereafter maintain workers’ compensation and comprehensive
general liability (bodily injury and property damage) insurance, with respect
to performance under this Agreement. 
Each party shall give the other or its representative immediately notice
of any suit or action filed, or prompt notice of any claim made, against them
arising out of the performance of this Agreement.

 

11.04      Product Liability.  TKT and CBL each agree at its own expense to
maintain Product Liability insurance coverage of at least $2.0 million.  TKT and CBL will provide a Certificate of
Insurance to the other upon request, and such coverage will remain in effect
indefinitely and so long as either party has product liability exposure for any
Product manufactured for TKT.  If such
Product Liability insurance is underwritten on a “claims made” basis, TKT and
CBL agree that any change in underwriters during the term of this Agreement
will require the purchase of “prior acts” coverage to ensure that coverage will
be continuous throughout the term of this Agreement.

 

11.05      Governing Law.  This Agreement shall be construed, and legal
relations between the parties hereto shall be determined, in accordance with
the laws of the State of Maryland applicable to contracts solely executed and
wholly to be performed within the State of Maryland without giving effect to
the principles of conflicts of laws.

 

11.06      Arbitration.  Any controversy or dispute by and between
the parties hereto or any of their Affiliates arising out of this Agreement
which is not resolved in good faith by the parties within sixty (60) days of
first becoming known to both parties, except with respect to resort to remedies
of injunction or other court order, shall be submitted to binding arbitration
in accordance with the Commercial Arbitration Rules then pertaining of the
American Arbitration Association, and judgment upon the award rendered thereby
may be entered in any court having jurisdiction thereof.  The place for arbitration shall be the city
of the company not bringing the request for arbitration.  The Parties to this contract shall select an
arbitrator based on mutual agreement. 
Nothing in this Agreement shall be construed or interpreted as granting
the arbitrators the power to award punitive damages as part of any award
rendered relating to this Agreement or the transactions contemplated
hereby.  The costs and expenses of such
arbitration shall be shared equally by the parties.

 

11.07      Notice.  All notices or communication required or
permitted to be given by either party hereunder shall be deemed sufficiently
given if mailed by registered mail or certified mail return receipt requested
or sent by overnight courier return receipt requested, such as Federal Express,
to the other party at its respective address set forth below or to such other
address as one party shall give notice of to the other from time to time
hereunder.  Mailed notices shall be
deemed to be received on the third business day following the date of
mailing.  Notices sent by overnight
courier shall be deemed received the following business day.

 

12

 

	
  If to TKT:

  	
  Transkaryotic Therapies, Inc.,

  195 Albany Street

  Cambridge, MA 02139

  Attn:  President and CEO

  Tel:  617-349-0200

  Fax:  617-491-7903

  
	
   

  	
   

  
	
  With a copy to:

  	
  Hale and Dorr, LLP

  60 State Street

  Boston, MA 02109

  Attn:  Steven D. Singer

  Tel:  617-526-6000

  Fax:  617-526-5000

  
	
   

  	
   

  
	
  If to CBL:

  	
  Chesapeake Biological Laboratories, Inc.

  1111 South Paca Street

  Baltimore, MD 21230-2591

  Attn:  President

  Tel:  410-843-5000

  Fax:  410-843-4414

  

 

11.08      Compliance with All Laws.  In all activities undertaken pursuant to
this Agreement, both CBL and TKT covenant and agree that each will in all
material respects comply with such Federal, state and local laws and statutes,
as may be in effect at the time of performance and all valid rules, regulations
and orders thereof regulating such activities.

 

11.09      Successors and Assigns.  CBL shall not assign this Agreement (or any
schedule hereto) without the prior written consent of TKT, except that CBL
shall be permitted to assign its rights and obligation hereunder with such
consent to (i) one or more of its Affiliates or (ii) the purchaser of all or
substantially all of its assets, through merger, consolidation or
otherwise.  TKT may assign this
Agreement upon (x) providing prior written notice to CBL; and (y) causing the
assignee to acknowledge, in writing, that it will be bound by the terms and
conditions of this Agreement.

 

11.10      No Waivers; Severability.  No waiver of any breach of this Agreement
shall constitute a waiver of any other breach of the same or other provision of
this Agreement, and no waiver shall be effective unless made in writing.  Any provision hereof prohibited by or
unenforceable under any applicable law of any jurisdiction shall as to such
jurisdiction be deemed ineffective and deleted herefrom without affecting any
other provision of this Agreement.  It
is the desire of the parties hereto that this Agreement be enforced to the
maximum extent permitted by law, and should any provision contained herein be
held by any governmental agency or court of competent jurisdiction to be void,
illegal and unenforceable, the parties shall negotiate in good faith for a
substitute term or provision which carries out the original intent of the
parties.  If the parties cannot reach
agreement upon such a substitute term or provision within sixty (60) days after
the original term or provision is held void, illegal or unenforceable, then the
matter shall be settled by binding arbitration in accordance with Section
11.06.

 

11.11      Entire Agreement; Amendment.  TKT and CBL acknowledge that they have read
this entire Agreement and that this Agreement, including the attached Exhibits
constitutes

 

13

 

the entire understanding and contract between the parties hereto and
supersedes any and all prior or contemporaneous oral or written communications
with respect to the subject matter hereof, all of which communications are
merged herein.  It is expressly
understood and agreed that this Agreement shall not be modified, amended or in
any way altered except by an instrument in writing signed by both of the
parties hereto.

 

11.12      Delays or Omissions.  Except as expressly provided herein, no
delay or omission to exercise any right, power or remedy accruing to any party
hereto, shall impair any such right, power or remedy to such party nor shall it
be construed to be a waiver of any such breach or default, or an acquiescence
therein, or in any similar breach or default be deemed a waiver of any other
breach or default theretofore or thereafter occurring.  Any waiver, permit, consent or approval of
any kind or character on the part of any party of any breach or default under
this Agreement, or any waiver on the part of any party of any provisions or
conditions of this Agreement, must be in writing and shall be effective only to
the extent specifically set forth in such writing.  All remedies either under this Agreement or by law or otherwise
afforded to any party, shall be cumulative and not alternative.

 

11.13      Force Majeure.  If either party fails to fulfill its obligations
hereunder (other than an obligation for the payment of money), when such
failure is due to an act of God, or other circumstances beyond its reasonable
control, including but not limited to fire, flood, civil commotion, riot, war
(declared and undeclared), revolution, action by government including delays in
obtaining governmental approvals or embargoes, then said failure shall be
excused for the duration of such event and for such a time thereafter as is
reasonable to enable the parties to resume performance under this Agreement.

 

11.14      Further Assurances.  Each party shall, at any time, and from to
time, prior to or after the effective date of this Agreement, at reasonable
request of the other party, execute and deliver to the other such instruments
and documents and shall take such actions as may be required to more
effectively carry out the terms of this Agreement.

 

11.15      Survival.  All representations, warranties, covenants
and agreements made herein and which by their express terms or by implication
are to be performed after the execution and/or termination hereof, or are
prospective in nature, shall survive such execution and/or termination, as the
case may be.  Specifically Sections
5.03, 5.05, 10.03, and Article IX shall survive such termination and Articles
VI, VII, and XI shall survive for so long as any Product produced by CBL for
TKT remains within its expiration dating.

 

11.16      No Third Party Beneficiaries.  Nothing in this Agreement shall be construed
as giving any person, firm, corporation or other entity, other than the parties
hereto and their successors and permitted assigns, any right, remedy or claim
under or in respect of this Agreement or any provision hereof.

 

11.17      Headings.  Section headings are for convenient
reference and not a part of this Agreement. 
All Exhibits are incorporated herein by this reference.

 

14

 

11.18      Counterparts.  This Agreement may be executed in
counterparts, each of which shall be deemed an original and all of which when
taken together shall be deemed but one instrument.

 

11.19      No Rights.  No rights or licenses with respect to the
Product or any of either party’s intellectual property rights and granted or
deemed granted hereunder or in connection herewith, other than those rights
expressly granted in this Agreement.

 

11.20      Disclosure.  Except as TKT may be required by law or
regulation, neither party shall disclose the name of the other party, the
identity of the Product or any information with respect thereto, the existence
of this Agreement or the terms and provisions of this Agreement without the
prior written approval to the other party. 
Neither party shall use the name of the other party in any publicity or
advertising without the other party’s prior written consent.  If CBL is required in accordance with SEC or
other relevant governmental regulations to disclose TKT’s name, the existence
of this Agreement or the terms and provisions of this Agreement, CBL shall (i) give
TKT prior written notice of such disclosure, and (ii) assist TKT in any efforts
to prevent or limit such disclosure including without limitation seeking
confidential treatment of such information.

 

IN WITNESS WHEREOF, this Agreement shall take effect
as of the date first written above when it has been executed below by the duly
authorized representatives of the parties.

 

 

	
  CHESAPEAKE BIOLOGIC LABORATORIES, INC.

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
          /s/ Thomas
  P. Rice

  	
   

  
	
   

  	
  Title: 
  Thomas P. Rice, President & CEO

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  TRANSKARYOTIC THERAPIES, INC.

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
          /s/ Richard
  F. Seldon

  	
   

  
	
   

  	
  Title: 
  Richard F. Selden, President & CEO

  	
   

  

 

Exhibits:

Exhibit A:  Project Summary.

Exhibit B: 
Validations/Qualifications.

Exhibit C:  Price.

 

15

 

EXHIBIT
A

 

PROJECT
SUMMARY

 

 

 

CONFIDENTIAL

 

 

1

 

TRANSKARYOTIC
THERAPIES, INC.

PROJECT
SUMMARY

 

Transkaryotic Therapies, Inc. (TKT) desires Chesapeake Biological
Laboratories, Inc. (CBL) to formulate and aseptically fill, package and label
for clinical and commercial use the product known as (gene activated)
GA-GAL.  The active ingredient is
α-Galactosidase A, an acid hydrolase which specifically cleaves terminal
α-linked galactose residues from glycosphingolipid ceramide trihexoside
(CTH).  A

 

The Project will consist of the following parts.

 

1.        Clinical
Manufacturing Phase

a.         Technology [**]

b.         Technology [**].

c.         Acquisition and testing of [**].

d.         Preparation of [**].

e.         Production of [**].

 

2.        Validation
Phase

a.         Execution of [**].

b.         Preparation of [**].

 

3.        Consistency
Lot Manufacturing

a.         Production of [**]Production of [**]

b.         Assist TKT in [**]

 

4.             Commercial
Manufacturing (requirements to be determined)

 

*Contact at TKT is Bill Fallon: 
Phone (617) 349-0203  Fax (617)
491-7903

Program Manager at TKT is Suzanne Bruhn:  Phone (617) 503-0394  Fax
(617) 491-7903

 

2

 

Overview of Formulation and Fill
Processes

 

Following is an outline of the formulation, filtration, aseptic
filling, QC testing, labeling, and packaging to be performed:

 

1.         TKT will supply the active pharmaceutical ingredient (API)
and text for the vial label, unit carton and package insert.

2.         CBL will supply all equipment, chemicals, and materials
required to produce and test the product.

3.         All receipt, in-process and certain release* testing will be
performed by CBL.

4.         API will be received as a frozen bulk in 2 L PETG bottles
filled to ~ 1 L.

5.         Samples of API will be tested per receipt testing
requirements.

6.         API will be thawed, formulated, filtered and aseptically
filled into 5 cc vials (3.5 cc label claim), stoppered and crimped.

7.         Drug product will be stored at 2 - 8°C.

8.         Vials containing drug product will be visually inspected, QC
tested, labeled and packaged appropriately.

 

A Certificate of Analysis and any other documentation required will be
supplied along with the API to CBL prior to the scheduled date of manufacture.

 

Each container of API will be sealed with tamper evident tape or device
and labeled with the gross and net weight and temperature storage
condition.  Each shipping container of
API should be labeled as “Store @-20°C. 
Upon arrival, CBL will inspect for tampering, weigh each container and
receive per CBL SOP’s.  The API will
then be stored until required for manufacture.

 

At the completion of all work for each lot, CBL will provide TKT with a
copy of the completed Batch Production record including a Certificate of
Analysis.

 

 

3

 

TESTING
REQUIREMENTS

 

CBL
Testing of API Upon Receipt

 

	
  Volume
  Required

  	
   

  	
  Delivered
  To

  	
   

  	
  Assay

  	
   

  	
  Specification

  	
   

  
	
  [**]

  	
   

  	
  CBL QC-Lab

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
  [**]

  	
   

  	
  CBL QC-Lab

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  

 

*may be performed
by TKT if technical transfers are not complete

 

In-Process
Testing of Formulated Bulk

 

	
  PRE-FILTRATION/POST-QS

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  #
  Samples/Vol

  	
   

  	
  Delivered
  To

  	
   

  	
  Assay

  	
   

  	
  Specification

  	
   

  
	
  [**]

  	
   

  	
  CBL-Micro

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
  [**]

  	
   

  	
  CBL QC-Lab

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
   

  	
   

  	
  CBL-Pharm Tech

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  

 

	
  POST-FILTRATION

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Volume
  Required

  	
   

  	
  Delivered
  To

  	
   

  	
  Assay

  	
   

  	
  Specification

  	
   

  
	
  [**]

  	
   

  	
  CBL-Micro

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
  [**]

  	
   

  	
  CBL-Pharm Tech

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  

 

Final
Drug Product Testing

 

	
  #
  Samples/Vol

  	
   

  	
  Delivered
  To

  	
   

  	
  Assay

  	
   

  	
  Specification

  	
   

  
	
  [**]

  	
   

  	
  CBL-Micro-Lab

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
  [**]

  	
   

  	
  CBL Micro-Lab

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
  [**]

  	
   

  	
  CBL QC-Lab

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
  [**]

  	
   

  	
  CBL QC-Lab

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  

 

 

4

 

DETAILED
DESCRIPTION OF FORMULATION, ASEPTIC FILLING, LABELING AND PACKAGING

 

Overview

 

Receipt of Bulk Drug Substance

 

Bulk material will be delivered to CBL at least [**] prior to
formulation.  Upon receipt, the bulk
will be stored at [**].  A sample sent
with the bulk will be tested as specified in testing requirements.  All batch record steps are performed in
accordance with Good Manufacturing Practices.

 

Preparation of Diluent

 

GA-GAL diluent is prepared within [**] of use by mixing appropriate
quantities of [**].  The composition of
GA-GAL diluent is listed in Table 4.4-1.

 

Table 4.4-1.  Composition of GA-GAL Diluent (per Liter)

 

	
  Component

  	
   

  	
  TKT Part Number

  	
   

  	
  Quantity

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  
	
  [**]

  	
   

  	
  [**]

  	
   

  	
  [**]

  	
   

  

 

The diluent is filtered [**] until required.  All filters are subjected to post-filtration
integrity testing.

 

Formulation of α-Galactosidase
A for Injection, by CBL

 

The formulation of the Product will be performed in
Class [**] conditions.

 

Only [**]% of the purified bulk will be initially used
to ensure that material is available for adjustment in the event that the
formulated bulk is too dilute.

 

Based on the volume and concentration of the bulk and
the desired concentration of GA-GAL in the final formulation, the volume of
GA-GAL diluent required for addition is determined.  An appropriate amount of diluent is added to [**]% of the target
final volume.  Then [**] is added, the
solution is pH adjusted and finally Q.C. tested for concentration and pH.

 

Sterile Filtration

 

The formulated bulk drug product is sterile filtered
through [**]  Filtration is conducted
[**] and then the filter(s) is subjected [**]. 
All filter integrity testing must be completed with acceptable results
before the material is released for further processing.  CBL maintains a stringent accountability
record on all steps of the filtration process.

 

5

 

Aseptic Filling and Sealing

 

Filling is conducted in a Class [**] room by trained
technicians using validated processes for low volume fills.  The filling process is performed using an
[**].  The weight of fill per vial is
set and checked at the beginning of the fill. 
Additional weight checks are usually conducted at an interval of [**]
and on the last vial filled.  Weight
check vials are identified, isolated as weight checks and noted in the
accountability records.

 

During the filling process each vial is purged
[**].  Each vial is then [**].  Upon completion of the fill, a complete
product accountability is performed for the filling process.  The filled units in labeled trays are
transferred to the appropriate storage conditions (2-8°C) awaiting further
processing.

 

Inspection

 

The batch record includes a Bill of Materials,
Signature Log, and Final Product Accountability.  A 100% visual inspection is conducted using a black and white
background.  Reject samples are
classified by CBL.  Other defects are
also isolated, for example, improper crimps, container flaws, and stopper
defects.  Approved inspected units are
then made available to the labeling group, who are responsible for label
accountability, proper labeling, and packaging.

 

Storage

 

Upon completion of inspection, all passed units are
quarantined and stored at 2-8°C, awaiting final release.

 

Unit Labeling

 

The drug product vials will be labeled as follows:

 

α-Galactosidase
A 1 mg/mL Sterile

3.5 mL Lot No.:  #####

Caution:  New
Drug - Limited by Federal Law to Investigational Use

Store at 2-8°C

Transkaryotic Therapies Inc.

195 Albany Street

Cambridge, MA 02139 USA

 

Any changes in labeling text as may occur from time to
time, must be sent to the attention of CBL a minimum of 6 weeks prior to the
anticipated date of manufacture.

 

Packaging

 

GA-GAL drug product is [**].  Vials are [**].

 

The α-Gaacosidase A drug product will be bulk
packaged and shipped to TKT in a temperature-controlled, monitored
container.  If more than one shipper
container is necessary,

 

6

 

each container will contain a temperature monitor.  The shipping containers will be labeled as
follows:

 

α
-Galactosidase A Sterile

Lot no. ####

Quantity enclosed: 
## vials

Caution:  New
Drug - Limited by Federal Law to Investigational Use

Single use vials

Refer to Clinical Protocol and Investigator’s Brochure
for administration directions

Store at 2-8°C

 

Transkaryotic Therapies Inc.

195 Albany Street

Cambridge, MA 02139 USA

 

Upon commercialization, the labeling and packaging
will be changed from bulk.  All
necessary text and specifications will be supplied by TKT prior to that time.

 

Retain
Samples

 

CBL holds retain samples for commercial products.  Retain samples will be invoiced as regular
product, but held at CBL under label storage conditions.  The number of retains will be determined by
the amount of finished product testing required.  Usual practice is to retain sufficient samples to perform all of
the testing two times.  The retained
samples will be held for one year past the expiration date of the lot and CBL
will properly dispose of such samples for TKT, or return to TKT upon request.

 

Stability
Samples

 

Stability in its entirety will be the responsibility
of TKT.  Any samples held by CBL for
stability will be subject to a separate agreement.

 

Shipping

 

Final Product to be shipped overnight to:

 

Transkaryotic Therapies, Inc.

195 Albany Street

Cambridge MA 02139

 

or another designated site as determined by TKT.

 

Manufacturing Batch Record Summary

 

All operations are governed by a CBL batch record
developed exclusively for TKT’s GA-GAL product.  The approved batch record is assigned a TKT project number and a
unique CBL lot number.  These documents
detail the preparation of materials (vials, stoppers, closures,

 

7

 

processing materials, and equipment) used in the manufacturing
process.  The batch record has been
approved by Quality Assurance and Manufacturing at TKT along with appropriate
approvals from CBL.  CBL staff has the
responsibility to perform the aseptic processing and related processing to the
instructions detailed in the approved Batch Records.  CBL has provided TKT the opportunity to review validation data
and reports that reflect the processing of components that have intimate
contact with the product.

 

Reference to the environmental monitoring and
personnel monitoring is noted along with the actual data.  Before proceeding with manufacturing
operations, the operation room conditions are verified for temperature and
pressure.  CBL performs a [**] prior to
filtration and [**] prior to filling.

 

The batch record is designed to include all quality
control testing performed at CBL.  The
batch record references an SOP to the central sample receiving, in-processing
testing (pre and post filtration) and final product testing.  The documentation references an SOP to a
detailed sampling plan for [**].  The
final product testing section relates to tests conducted at CBL and other
contracted testing facilities approved by TKT. 
Final [**] testing at CBL includes [**].  A final Certificate of Analysis is presented along with final
review and signature by CBL Quality Assurance.

 

Batch Record Availability

 

At the completion of all work for each lot, CBL will
provide Client with a copy of the completed Batch Production Record including a
Certificate of Analysis.  The “batch
record” is normally complete within [**] after a fill date unless otherwise
agreed upon previously.  CBL will work
in good faith to reduce the time needed for completion of the batch record.

 

Disposal or Disposition of Product

 

Remaining bulk product will be refrozen and all
inspection rejects will be stored refrigerated.  All will be returned to the client.

 

8

 

Transkaryotic
Therapies, Inc.

 

 

 

 

 

Chart

 

 

 

**Confidential
Materials omitted and filed separately with the

Securities and Exchange Commission.**

 

 

 

9

 

EXHIBIT
B

 

VALIDATION
PROCESSES

 

CONFIDENTIAL

 

10

 

VALIDATION
PROCESS

 

USP Testing of Raw Materials (Europe,
Japan and USP)

 

Chemicals purchased with the “USP” or “NF” grade are
suitable for use in Pharmaceutical products. 
Under cGMP they need to undergo only identity testing in addition to
establishing the reliability of the suppliers analyses at appropriate intervals
in order to be released for use in a regulated product.  It is sometimes misunderstood by clients
that other chemical grades, such as ACS or Aldrich gold, which are perceived as
superior products by the criteria of purity and strength, are not approved for
use as parenterals in humans.  For CBL
to use non USP/NF raw materials, it is necessary to perform full USP testing on
the chemical, thereby certifying that it meets the requirements of USP/NF.

 

For those chemicals that are not compendial (US
Pharmacopoeia), appropriate tests must be identified to assess identity;
purity, quality, and strength.  At an
appropriate time, that testing must be validated according to guidelines from
“Validation of Compendial Assays”  USP
XXIII <1225>.  For concentration
(strength) the assay validations are needed for CBL to guarantee formulation
results.  For other assays, the
validation can wait until phase III production, or until it is needed for a
guarantee of conformance to specifications.

 

Assay Tech Transfer
[Qualification/Validation]

 

Evaluation of any Compendial or client supplied assay
must be made prior to CBL accepting responsibility for its quantitative
use.  Compendial assays are assumed to
be fully validated and require only a demonstration of their applicability to
the analyte as formulated. 
Client-supplied assays, for which full validation exists, may also be
used upon demonstration of congruency, usually involving the comparison of data
on a single set of samples which have been assayed in both the client’s and
CBL’s laboratories.  Non-validated
assays for use in early stage (up to early Phase II) testing will also require
a transfer of technology with direct comparison of samples between
laboratories.  Technology transfers as
described above will require demonstration of accuracy, precision, ruggedness
and linearity.  Later stages of the drug
approval process require validated assays. 
If called upon to validate an assay, CBL will follow the guidelines of
USP XXIII <1225>.  Assays for use
in stability programs must be validated regardless of stage of drug development
and must be shown to be stability indicating.

 

Assay tech transfers will be required for [**]

 

Bacteriostasis / Fungistasis (for
Product)

 

B/F is required in order to establish the potential of
the formulation to interfere with sterility assays.  B/F testing can be performed on developmental batches as long as
they are prepared with GNP material which meets specifications for incoming raw
material and have the same formulation as will the GNP batches.

 

Enhancement / Inhibition (for
Product)

 

E/I evaluates the potential for interference by the
formulation with the assay used to measure endotoxin.  A preliminary E/I determination will be required to allow quantitation
of endotoxin in developmental batches. 
Full validation of E/I is required once preparation of GNP batches
begins.  Validation involves performing
E/I on three consecutive batches.

 

 

11

 

Filter Function/Compatibility Study

 

All materials have some affinity for filter
media.  In some instances, that affinity
is sufficient to cause concern about the ability to filter product and maintain
concentration through the process.  A
successful study is one in which no significant differences are observed when
comparing the drug product pre and post filtration.  These results help to assure the concentration of product after
filtration.  This is particularly a
problem with biological products and products with very low concentrations.

 

Cleaning Recovery Study

 

Contract manufacturers must be able to assure
themselves, their clients, and the FDA that no significant chance exists for
cross contamination to occur among products sharing equipment which may
conceivably contact product.  While the
interior of the lyophilizer (for example) is certainly not designed to be a
product contact surface, the possibility that product may reach the lyophilizes
shelves and be dried down on them does present a potential for contamination
from a dislodged fragment of some previous client’s product.  CBL requires demonstration that products are
easily removed from glass or stainless steel surfaces (as appropriate) by the
routine cleaning methods called for in CBL cleaning procedures.  The cleaning study involves spotting product
onto a stainless steel coupon or tray and simulating the method for cleaning
the inside of the lyophilizer.  Recovery
of the product from a stainless steel surface and evaluation of cleaning are
monitored by TOC (Total Organic Carbon) analysis which, while lacking the
specificity of methods such as BPLC, compensates by virtue of its
sensitivity.  The cleaning study is
expected to demonstrate removal of product from the steel surface.  While a negative result is not expected,
such a result would require additional evaluation of the data obtained and
close consultation with the Client regarding the ability of CBL to proceed.

 

Equipment Cleaning Validation

 

Three successive
successful demonstrations.

 

To validate the ability of CBL to prevent cross
contamination from Client product, three successive successful demonstrations
of effective cleaning of product contact equipment will be required.  Collection of each data set will occur after
an actual manufacturing event with GMP product.  Technicians will sample predetermined sites within the equipment
for TOC.  The most common equipment for
Cleaning Validation are tanks and Pump contact parts.  CBL attempts to use as much virgin equipment as possible in order
to reduce the need for rigorous and extensive cleaning validation.

 

Product Hold Time Studies:

 

The most efficient way to schedule formulation and
fill is to do the formulation on the day prior to the fill.  A holding study allows CBL to demonstrate
that the product will not be adversely affected by holding it for 12-48 hours
at cold room conditions with or without an initial filtration to lower
bioburden.  Bench scale batches will be
formulated, treated and stored according to a standard protocol.  Potency and other properties which might be,
affected by storage will then be analyzed.

 

 

12

 

Filling Machine Fill Volume
Qualification

 

CBL will perform a fill volume study with the actual
product (or placebo) to assure machine process capability.  This study will set the target volume for
the fill using volume specifications or label data for the product.  Typically, a minimum alert level is set at +3
sigma from the target weight for the fill volume.  The specification is then set slightly outside of those alert
levels.

 

Filter Extractables Study

 

This is an FDA requirement for phase III.  Product is filtered and the effluent is
assayed for known extractable substances. 
For a purely aqueous product, it is normally not of any consequence.  It is typically performed by the filter
manufacturer.

 

Microbial Retention Study

 

Subcontracted to Millipore.  Laboratory testing is conducted with specific pharmaceutical
biopharmaceutical product using a standard protocol using B. diminuta grown in
saline lactose broth.  These experiments
are run at room temperature for less than 24 hours on 47 mm disk membranes with
less than 20 liters of solution. 
Microbial Retention Validation is performed to validate microbial
retention of sterilizing-grade membrane filters with specific pharmaceutical
preparation.  Microbial retention
testing was recommended by the US Food and Drug Administration’s 1987
“Guideline on Sterile Drug Products Produced by Aseptic Processing” to validate
sterilizing-grade membrane filter performance. 
Under worst case process conditions, the testing determines the ability
of a sterilizing-grade filter using scaled-down processing conditions to retain
a minimum challenge of 10 cells of B. diminuta per cm2 of filter area.  A sample of one drug product lot is
evaluated using filters from three manufacturing lots.  Initial testing determines whether the
sample drug product inhibits the microbial challenge prior to conducting the
microbial retention studies.  This
initial testing will determine the mode of the final testing, ie., whether it
is performed in the presence or absence of the product.

 

Validation Package for BLA

 

In support of product approval applications, CBL
maintains Master Files at FDA for both its Seton and Camden facilities.  Clients may request letters authorizing FDA
to review CBL’s file in support of their regulatory application (e.g., NDA,
ANDA, BLA).

 

The file contains pertinent information on building
and facilities, overall manufacturing operation flow patterns, equipment
locations, component sterilization validations (e.g. oven and autoclave loads),
action concerning product when media fills fail, details of the environmental
monitoring program (viables and non-viables), initial vial and stopper washing
validations and utility system validations such as production of water for
injection and distribution, clean steam production and distribution, and HVAC
systems validations.

 

Aseptic processing validations are supplied as a
summary sheet outlining CBL media fill history.

 

 

13

 

Finally, the process validation package supplied for
the BLA will contain the prospective protocol and the results of the enhanced
testing program from the (recommended) three at scale conformance lots.  This enhanced testing will be used to
demonstrate control of critical manufacturing operations such as mixing
uniformity during formulation as well as conformance to production
specifications throughout the filling process.

 

14

 

EXHIBIT
C

 

PRICING
& PAYMENT

SCHEDULE

 

 

CONFIDENTIAL

 

 

15

 

PRICING
AND PAYMENT SCHEDULE

 

I                                            Validation Package

 

	
  Title

  	
   

  	
  Deliverable

  	
   

  	
  Price

  	
   

  
	
  [**]

  	
   

  	
  Testing Standards

  	
   

  	
  $[**] per new test

  	
   

  
	
  [**]

  	
   

  	
  Validation Report Report

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Report

  	
   

  	
  $[**]

  	
   

  
	
   

  	
   

  	
  Report

  	
   

  	
  $[**]

  	
   

  
	
  [**]

  	
   

  	
  Report

  	
   

  	
  $[**]

  	
   

  
	
  [**]

  	
   

  	
  Report

  	
   

  	
  $[**]

  	
   

  
	
  [**]

  	
   

  	
  Report

  	
   

  	
  $[**]

  	
   

  
	
  [**]

  	
   

  	
  Report

  	
   

  	
  $[**]

  	
   

  
	
  [**]

  	
   

  	
  Report

  	
   

  	
  $[**]

  	
   

  
	
  [**]

  	
   

  	
  External Report

  	
   

  	
  $[**]

  	
   

  
	
  [**]

  	
   

  	
  Report

  	
   

  	
  $[**]

  	
   

  
	
  [**]

  	
   

  	
  Reference Letter

  	
   

  	
  $[**]

  	
   

  
	
  [**]

  	
   

  	
  External Report

  	
   

  	
  $[**]

  	
   

  
	
  [**]

  	
   

  	
  Report

  	
   

  	
  $[**]

  	
   

  

 

(1) This charge will not apply if the filter function study is
performed in conjunction with the process validation, listed here as
“Validation Package for BLA”.

 

(2) CBL has bracketing media fills that cover the following
vial/stopper/crimp combination

 

[**].

 

If this or any combination is used for which CBL has
existing media fills and change parts, then no special media fills will be
performed and there will be no media fill charge.

 

(3) If CBL bracketing media fills are used to support a client’s
application then this charge will apply.

 

II                                        Lot Price / Unit Price* (Includes packaging, FOB CBL’s
dock)

 

For lot sizes less than [**] units                       $[**] per unit

For lot sizes of [**] units or more                     $[**] per unit [**]

 

*Price includes an allowance of $[**]/unit [**].  Costs in excess of the allowance will be
charged at [**] %.

 

III                                    Minimum
Purchase Orders

 

The minimum annual purchase order requirement is [**].

 

 

16

 

IV                                   Basis for Price Increase

 

Price per lot is comprised of [**].  Following FDA approval of CBL as the
manufacturer, and for the first year the prices will hold.  Thereafter the price may be increased annually
based on (i) actual increases in packaging component cost (syringes, stoppers,
crimps, labels inserts, cartons), (ii) non-component costs may be increased
based upon a weighted average factor using both the Bureau of Labor Statistics,
employment cost index series ID ECU 19002A, (ECU and the Consumer Price Index
(CPI).  [**]% of the non-component cost
of the price per lot will be subject to increases in the ECU.  The remaining [**]% of the non-component
cost price per lot will be subject to increase in the CPI adjusted annually.

 

 

17<PAGE>

                                                                   Exhibit 10.27

                           SECURITY AND LOAN AGREEMENT

         This Security and Loan Agreement is made on November 4, 2002 by and
between InforMedix Acquisition Corp., a Delaware Corporation ("IMAC"), its
wholly-owned subsidiary, InforMedix, Inc., a Delaware Corporation ("IMI"),
duly-authorized as a foreign corporation to transact business in the State of
Maryland and each having a business address in said State at 5880 Hubbard Drive,
Rockville, MD 20852 (IMAC and INI are collectively referred to herein as the
"Debtor") and Private Investors Equity, LLC ("Secured Party").

                                    RECITALS:

         Debtor and Warren & Lewis Investment Corporation, as correspondent on
behalf of Secured Party, entered into the Commitment Letter whereby Secured
Party was to fund unto Debtor the Loan. The Loan was funded by Secured Party and
is evidenced by the Convertible Promissory Note ("Note"), which instrument is
secured by this Security and Loan Agreement and public notice thereof is made by
the filing of one or more financing statements pursuant to the laws of the
Jurisdiction. In consideration of Ten Dollars ($10.00) in hand paid and in
consideration of the Loan, the parties have entered into this instrument.

                                   WITNESSETH:

         1. Grant of Security Interest. For value received and to secure payment
and performance of the Obligations of Debtor as Borrower to Secured Party as
Lender, however created and arising out, and, except with respect to the Senior
Lienors pursuant to the Senior Lien Instruments, grants and first and exclusive,
otherwise pursuant to or in connection with the Note, Debtor hereby grants to
Secured Party a continuing security interest in and lien upon the following
described property, whether now owned or hereafter acquired, and any additions,
replacements, accessions, or substitutions thereof and all cash and non-cash
proceeds and products thereof and called the "Collateral" and described on
Exhibit "A" appended hereto and made a part hereof.

         2. Debtor's Representations and Warranties - Covenants and Agreements.
If a representation and warranty, Debtor hereby represents, warrants and agrees
each of the following statements are true, valid, complete and correct, if an
affirmative covenant, Debtor represents, warrants and covenants to abide thereby
and if a negative covenant, Debtor represents, warrants and covenants not to
breach the same, to wit:

                  A. Ownership of the Collateral. Debtor owns the Collateral,
the Collateral is free and clear of all liens, security interests, and claims
except those previously reported in writing to or approved by Secured Party and
liens and security interests granted to Senior Lienors and Debtor will keep the
Collateral free and clear from all liens, security interests and claims, other
than those granted to or approved by Secured Party. All income, dividends,
earnings and profits with respect to the Collateral shall be reported for state
and federal income tax purposes as attributable to Debtor and not Secured Party.

                                       1
<PAGE>

                  B. Names and Offices; Jurisdiction of Organization; Alteration
of Articles of Incorporation and By-Laws - Reorganization - Spinoff; Shares of
Stock - Issued and Outstanding.

                  B. (i) The name and address of Debtor appearing at the
beginning of this Agreement is Debtor's exact legal name and the address of its
chief executive office. There has been no change in the name of Debtor, or the
name under which Debtor conducts business, within the five (5) years preceding
the date hereof except as previously reported in writing to Secured Party.
Debtor has not moved its chief executive office within the five years preceding
the date hereof except as previously reported in writing to Secured Party.
Debtor is organized under the laws of the State of Delaware and has not changed
the jurisdiction of its organization within the five (5) years preceding the
date hereof except as previously reported in writing to Secured Party. The
parties executing all Loan Documents are duly-authorized to do so and have been
specifically granted such authority under resolutions duly given and approved by
the Board of Directors of Debtor. So long as any of the Obligations remain
outstanding, Debtor shall not except as provided in subsection B. (ii) of this
Section 2, (x) amend its Articles of Incorporation, its By-Laws or any of its
agreements or documents regarding its corporate governance, or (y) "spin-off"
any of its assets to any subsidiary or affiliate or otherwise having a direct or
indirect affect as any reorganization, recapitalization, subdivision or
otherwise (the events described in (x) and (y) above are collectively referred
to herein as "Material Events"). There are, as of this date, shares of stock
authorized and outstanding, fully-paid and non-assessable of IMAC, as follows:
Common Shares, 100,000,000 shares authorized and _____________ shares
outstanding; there are, as of this date, shares of stock authorized and
outstanding, fully paid and nonassessable of IMI, as follows: Common Shares,
5,000,000 shares authorized and _______ shares outstanding.

                  B. (ii) Subject to the other terms hereof, Debtor shall have
the right, after securing Secured Party's prior written consent, to undertake
the actions provided in (x) and (y) of the preceding paragraph. Secured Party
agrees not to withhold its consent so long as such action, in Secured Party's
reasonable judgment, does not have any material adverse effect upon the
Collateral. Subject to the provisions of the conditions of this sentence and the
provisions of the conditions of the sentence immediately following this
sentence, Secured Party agrees to make its determination within ten (10)
business days after receiving Debtor's written request (the "Debtor Notice") and
such reasonable supporting documentation regarding the request as required by
Secured Party; the Debtor Notice shall be accompanied by any information,
documents and materials which support Debtor's contention that there is no
material adverse effect upon the Collateral ("Supporting Materials"). Should the
Supporting Materials be insufficient for Secured Party's review, Secured Party
agrees to notify Debtor (the "Secured Party Request") within three (3) business
days of receipt of the Debtor Notice and Debtor shall, thereupon, use its best
efforts to deliver all such supporting documents within three (3) days of
receipt of the Secured Party Request. As a precondition to issuing its consent
hereunder, Debtor shall pay the Secured Party's reasonable costs and fees to
review and underwrite Debtor's requests made relative thereto. Notwithstanding
any rule of law to the contrary but except for cases of bad faith on the party
of the Secured Party, in any action which seeks to adjudicate or arbitrate any
of Debtor's rights hereunder, Debtor's sole and absolute remedy shall be one
based in equity and no remedy in damages shall be assessed.

                                       2
<PAGE>

                  B. (iii) Notwithstanding anything herein to the contrary, in
the event that any Material Event would result in the Debtor raising sufficient
funds to repay the Obligations and the Obligations are repaid from the proceeds
from such Material Event, the Secured Party may not withhold its consent to such
Material Event provided that repayment of the Obligations are a condition to the
closing of the transactions contemplated by the Material Event.

                  C. Title and Taxes - Maintenance, Protection and Impairment of
the Collateral. Debtor has good and marketable title to Collateral and will
warrant, protect and defend same against all claims. Debtor will not transfer,
sell, or lease Collateral, except in the ordinary course of business. Debtor
agrees to pay promptly all taxes and assessments upon or for the use of
Collateral and on this Security Agreement. At its option, Secured Party may
discharge taxes, liens, security interests or other encumbrances at any time
levied or placed on Collateral. Debtor agrees to reimburse Secured Party, on
demand, for any such payment made by Secured Party. Any amounts so paid shall be
added to the Obligations. Debtor shall take all need actions necessary to insure
that the security for the Loan is not impaired. Should there result impairment
of the Collateral, Debtor shall promptly notify Secured Party and Debtor, at its
sole cost and expense, promptly restore the Collateral. Should Debtor elect to
sell or transfer any of the Collateral, no transfer or sale may be made unless
conducted in a commercially reasonable manner with a bona fide effort to obtain
a sale price of at least market value as determined by Secured Party.

                  D. Waivers. Debtor agrees not to assert against Secured Party
as a defense (legal or equitable), as a set-off, as a counterclaim, or
otherwise, any claims Debtor may have against Secured Party. Debtor waives all
exemptions and homestead rights with regard to the Collateral. Debtor waives any
and all rights to any bond or security which might be required by applicable law
prior to the exercise of any of Secured Party's remedies against any Collateral.
All rights of Secured Party and security interests hereunder, and all
obligations of Debtor hereunder, shall be absolute and unconditional, not
discharged or impaired irrespective of (and regardless of whether Debtor
receives any notice of) any lack of validity or enforceability of any of the
Loan Documents; any change in the time, manner or place of payment or
performance, or in any term, of all or any of the Obligations or the Loan
Documents or any other amendment or waiver of or any consent to any departure
from any of the Loan Documents; any exchange, release or non-perfection of any
collateral, or any release of or modifications of the obligations of any
guarantor or other obligor and any amendment or waiver of or consent to
departure from any Loan Document or other agreement. To the extent permitted by
law, Debtor hereby waives any rights under any valuation, stay, appraisement,
extension or redemption laws now existing or which may hereafter exist and
which, but for this provision, might be applicable to any sale or disposition of
the Collateral by Secured Party; and any other circumstance which might
otherwise constitute a defense available to, or a discharge of any party with
respect to the Obligations.

                  E. Change of Name and Place of Business. Debtor will notify
Secured Party in writing at least thirty (30) days prior to any change in:
Debtor's chief place of business; Debtor's name or identity; Debtor's
corporate/organizational structure or the jurisdiction in which Debtor is
organized. In addition, Debtor shall promptly notify Secured Party of any claims
or alleged claims of any other person or entity to the Collateral or the
institution of any litigation, arbitration, governmental investigation or
administrative proceedings against or affecting the Collateral. Debtor will
bear, on demand, the actual costs of preparing and filing any documents
necessary to protect Secured Party's liens, whether now or hereafter required by
Secured Party.

                                       3
<PAGE>

                  F. Financing Statements - Power of Attorney. Except for any of
the Senior Lienors' financing statements of record as of July 1, 2002, relating
to the Collateral, no financing statement (other than any filed or approved by
Secured Party in writing or filed or generated in connection with the Other
Obligations) covering any Collateral is on file in any public filing office. On
request of Secured Party, Debtor authorizes Secured Party to execute one or more
financing statements in form satisfactory to Secured Party and will pay all
reasonable costs and expenses of filing the same or of filing relative to this
Security Agreement in the appropriate public filing offices in the jurisdiction
of the Debtor's organization or elsewhere and with the United States Patent and
Trademark Office or any other office required by Secured Party and Secured Party
is authorized to file financing statements relating to Collateral without
Debtor's signature. In order to protect its rights under this Agreement, subject
to the Senior Lienors' rights in and to the Collateral and subject to the terms
of the escrow agreement of even date by and between Debtor, Secured Party and HD
National Title Group, LLC, Debtor hereby constitutes and appoints Secured Party
the true and lawful attorney of Debtor with full power of substitution to take
any and all appropriate action and to execute any and all documents or
instruments that may be necessary or desirable to accomplish the purpose and
carry out the terms of this Security Agreement, including, without limitation,
to complete, execute, and deliver any further or other documentation request by
Secured Party, Debtor and third party(ies) required in connection herewith (a
"Further Agreement"), instructions to third party(ies) regarding, among other
things, control and disposition of any Collateral, and endorsements desirable
for transfer or delivery of any Collateral, registration of any Collateral under
applicable laws, retitling any Collateral, receipt, endorsement and/or
collection of all checks and other orders for payment of money payable to Debtor
with respect to Collateral. The foregoing power of attorney is coupled with an
interest and shall be irrevocable until all of the Obligations have been paid in
full. Neither Secured Party nor anyone acting on its behalf shall be liable for
acts, omissions, errors in judgment, or mistakes in fact in such capacity as
attorney-in-fact except in the event of willful misconduct. Debtor ratifies all
acts of Secured Party consistent with this paragraph as attorney-in-fact. Debtor
agrees to take such other actions, at Debtor's sole and absolute expense, as
might be requested for the perfection, continuation and assignment, in whole or
in part, of the security interests granted herein and to assure Secured Party's
intended priority position subject to the rights of the Senior Lienors. Upon
Secured Party's request, Debtor will, at its own expense do all things
reasonably determined by Secured Party to be desirable to make the sale of the
Collateral in accordance with this Agreement valid, binding and in compliance
with applicable law.

                  G. Representations and Warranties Heretofore Given. All
representations and warranties heretofore given, including but not limited to
the description of the Collateral, whether oral or written and whether they
might be in the form of documents, instruments, materials, pro formas, business
plans, financial statements, income statements, contracts, cash flow forecasts,
materials and otherwise, upon which credit underwriting for the credit facility
are based are true, complete, valid and correct on the date made and on the date
hereof.

                  H. Business Purposes. The Loan evidenced by the Note and
otherwise with respect to the Loan Documents was transacted solely for the
purpose of carrying on or acquiring a business, mercantile purposes and for
engaging in a commercial enterprise and not for any personal or consumer needs.

                                       4
<PAGE>

                  I. Compliance with Laws. Debtor shall comply with all Federal,
State and local laws a breach of which would materially and adversely affect the
financial condition of Debtor, its ability to operate its business affairs and
own and use the Collateral, the value or status of the Collateral or the value
or status of Debtor's interest or ownership in the Collateral.

                  J. Transfer of Collateral. Except in the event of a Permitted
Reorganization, Debtor shall not permit the Collateral, or any part or portion
thereof of or any interest therein whether directly or indirectly or otherwise,
to be transferred (whether by voluntary or involuntary conveyance, merger,
operation of law, or otherwise) without the prior written consent of Secured
Party. Any transferee of the Collateral or any part or portion thereof or any
interest therein, by virtue of its acceptance of the transfer, shall (without in
any way affecting Debtor's liability under the Loan Documents) be conclusively
deemed to have agreed to assume primary personal liability for the performance
of Debtor's obligations under the Loan Documents.

                  K. Compliance with Agreements with Third Parties. Debtor shall
comply with all obligations it has with third parties, whether or not related to
the Collateral.

                  L. Maintenance of the Collateral - Inspection Rights. Debtor
shall keep and maintain the Collateral so as to insure that the security for the
Loan is not impaired, not commit or suffer any waste of the Collateral. Should
the Collateral be adversely affected or impaired by anyone, including Debtor,
Debtor shall promptly notify Secured Party. Debtor shall permit Secured Party or
its designee to inspect its documentation regarding the Collateral as provided
in this Agreement.

         3. INTENTIONALLY DELETED.

         4. Collateral Duties. Secured Party shall have no custodial or
ministerial duties to perform with respect to Collateral pledged except as set
forth herein; and by way of explanation and not by way of limitation, Secured
Party shall incur no liability for any of the following: the loss or
depreciation of Collateral (unless caused by its willful misconduct or gross
negligence); a failure to present any paper for payment or protest, to protest
or give notice of nonpayment, or any other notice with respect to any paper or
Collateral, a failure to ascertain, notify Debtor of, or take any action in
connection with any conversion, call, redemption, retirement or any other event
relating to any of the Collateral or the failure to notify any party hereto that
Collateral should be presented or surrendered for any such reason. Debtor
acknowledges that Secured Party is not an investment advisor or insurer with
respect to the Collateral; and Secured Party has no duty to advise Debtor of any
actual or anticipated changes in the value of the Collateral.

         5. Transfer of Collateral. Secured Party may assign its rights in
Collateral or any part thereof to any assignee who shall thereupon become vested
with all the powers and rights herein given to Secured Party with respect to the
property so transferred and delivered, and Secured Party shall thereafter be
forever relieved and fully discharged from any liability with respect to such
property so transferred, but with respect to any property not so transferred,
Secured Party shall retain all rights and powers hereby given.

                                       5
<PAGE>

         6. Inspection of Books and Records. Debtor will upon demand and, at its
sole cost and expense at all times keep accurate and complete records covering
each item of Collateral, including the proceeds therefrom. Secured Party, or any
of its agents, shall have the right, at intervals to be determined by Secured
Party and without hindrance or delay, at Debtor's sole costs and expense, to
inspect, audit, and examine the Collateral and to make copies of and extracts
from the books, records, journals, orders, receipts, correspondence and other
data relating to Collateral, Debtor's business or any other transaction between
the parties hereto. Debtor will at its expense furnish Secured Party copies
thereof upon request. Further, Debtor shall, without any advance request made by
Secured Party, and at all times promptly notify Secured Party of all changes in
the ownership of the stock of Debtor to the extent that any one individual,
entity or affiliated entities acquires more than five percent (5%) or more of
any of the stock of Debtor. At any time Secured Party may request, Debtor shall
furnish a complete statement, sworn to under penalty of perjury by an officer of
Debtor, setting forth all of the stockholders, officers, directors and Debtor
and the extent of their respective stock ownership or control. In the event
Debtor is aware of any other person having a beneficial interest in such stock,
the statement shall also set forth the name of such person and the extent of
their interest.

         7. Attorney's Fees and Costs of Collection. Debtor shall pay all of
Secured Party's actual Costs and Expenses relative to this Agreement, including
but not limited to all costs and expenses incurred in enforcing this Security
Agreement and in preserving and liquidating Collateral, any arbitration, the
costs of attorneys, paralegals, assistants, consultants and experts, whether
incurred with or without the commencement of a suit, trial, arbitration or
administrative proceeding, or in any appellate or bankruptcy proceeding.

         8. Default. Upon the occurrence of any of the following, a "Default"
shall occur under this Security Agreement shall exist:

         (a) a default under this Security Agreement or under any of the other
Loan Documents; any breach of any of the covenants, agreements, representations
or warranties under this Security Agreement or under any of the other Loan
Documents which shall continue for a period of thirty (30) days after notice
thereof has been sent by Secured Party to Debtor, or

         (b) any misrepresentation of any kind thereunder which shall continue
for a period of thirty (30) days after notice thereof has been sent by Secured
Party to Debtor,

         (c) any loss with respect to the Collateral or any devaluation thereof
which shall continue for a period of thirty (30) days after notice thereof has
been sent by Secured Party to Debtor,

         (d) any sale, lease or transfer or encumbrance of any Collateral not
specifically permitted herein without prior written consent of Secured Party
which shall continue for a period of thirty (30) days after notice thereof has
been sent by Secured Party to Debtor, or

         (e) the making of any levy, seizure, or attachment on or of Collateral
or any of the other properties of Debtor not set aside, discharged, or stayed
within thirty (30) days after the same was levied or within ten (10) days after
the expiration of any stay thereof which shall continue for a period of thirty
(30) days after notice thereof has been sent by Secured Party to Debtor, or

                                       6
<PAGE>

         (f) should Debtor consent in writing to, the appointment of a receiver,
trustee, or liquidator for it of Collateral or of all or substantially all of
its assets or files a voluntary petition in bankruptcy or makes an assignment
for the benefit of creditors, files a petition or an answer seeking a
reorganization, composition, adjustment, arrangement with creditors, or takes
advantage of any insolvency law, files an answer admitting the material
allegations of a petition filed against it in any, bankruptcy, reorganization,
composition, adjustment, arrangement, or insolvency proceeding, or is dissolved
as a result of an adversary suit or proceeding, which shall continue for a
period of thirty (30) days after notice thereof has been sent by Secured Party
to Debtor,

         (g) any execution or attachment levied against the assets of Debtor not
set aside, discharged, or stayed within thirty (30) days after the same was
levied or within ten (10) days after the expiration of any stay thereof, an
order, judgment, or decree is entered by any court of competent jurisdiction on
the application of a creditor, adjudicating Debtor a bankrupt or insolvent, or
appointing a receiver, trustee, or liquidator for Debtor, or of all or
substantially all of its assets, or an order of relief is entered against Debtor
pursuant to any bankruptcy statute or law and such order, judgment, or decree
continues unstayed and in effect for a period of thirty (30) days and is not
discharged within ten (10) days after the expiration of any stay thereof; any
attempt to terminate, revoke, rescind, modify, or violate the terms of this
Security Agreement or any of the other Loan Documents without the prior written
consent of Secured Party, or

         (h) any material adverse change in the finances of Debtor or a material
change in the management of Debtor which shall continue for a period of thirty
(30) days after notice thereof has been sent by Secured Party to Debtor, or

         (i) any breach under any of the terms, conditions or provisions of any
of the "Other Obligations," beyond any applicable notice, grace and cure period.

         9. Remedies Upon a Default. Upon any default hereunder, Liquidator
shall have the following rights and remedies:

         (a) Secured Party may accelerate the Note and exercise any of the
remedies it has under any of the Loan Documents;

         (b) Secured Party may instruct the Liquidator the take immediate
possession of the books and records regarding the Collateral and otherwise to
take such action as it determines under this Agreement, without notice or resort
to legal process, and for such purposes, Liquidator may enter upon any premises
on which such books and records regarding the Collateral or any part thereof may
be situated and remove the same therefrom, or, at option of the Liquidator,
render such Collateral unusable or dispose of said Collateral on Debtor's
premises with respect thereto;

         (c) Appointment to act hereunder by the Liquidator may be made without
notice having been given to the immediate appointment of a receiver for the
Collateral for which is entitled to act without regard to the value of the
Collateral or the solvency of any person liable for payment of the amounts due
under the Loan Documents;

         (d) Secured Party may require Debtor to assemble the books and records
regarding the Collateral and make them available to Liquidator, with respect to
such foregoing portions of the Collateral, at a place to be designated by
Liquidator and Secured Party;

                                       7
<PAGE>

         (e) INTENTIONALLY OMITTED.

         (f) Secured Party may require Debtor to deliver to Secured Party and
Liquidator lists or copies of the Patent and License related Accounts promptly
after they arise and will deliver to Secured Party, promptly upon receipt, all
Proceeds received by Debtor, including all Proceeds of the Accounts, in the
exact form in which they are received;

         (g) Secured Party or Liquidator may require Debtor to assign or endorse
all of the Collateral and related proceeds to Liquidator and Liquidator with
regard to such Collateral shall have full power to collect, compromise, endorse,
sell, or otherwise deal therewith as agent for Debtor;

         (h) Liquidator and Secured Party, in its discretion, may apply cash
proceeds to the payment of any Obligations secured hereby or may release such
cash proceeds to Debtor for use in the operation of Debtor's business;

         (i) Secured Party and Liquidator may, upon a default, notify the
Account debtors or other obligors with respect to the Collateral that it
controls that the Accounts have been assigned to such party and should be paid
to Secured Party;

         (j) Secured Party may notify any of the parties to whom Debtor is owed
money, accounts receivable, tangibles or intangibles, interests, whether
corporeal or incorporeal and take such action as is may lawfully take hereunder
and under applicable law;

         (k) Secured Party may require Debtor to notify all Account debtors and
indicate on all invoices to such Account debtors that the Accounts are payable
to Secured Party.

         (l) Secured Party shall be authorized to notify any third party vendor
or contracting party or any party under any agreement given as a part of the
Collateral and act consistent with its rights hereunder; transfer into Secured
Party's name or the name of its nominee, all or any part of the Collateral;

         (m) Secured Party may receive all interest, dividends, and other
proceeds of the Collateral;

         (n) Liquidator may notify any person obligated on any such Collateral
to which it may act of the security interest of Secured Party therein and
require such person to make payment directly to Secured Party or Liquidator on
demand and also demand, sue for, collect or receive any proceeds of the
collateral thereof, and/or make any settlement or compromise as Secured Party or
Liquidator deems desirable with respect to any such Collateral;

         (o) Otherwise, Secured Party and Liquidator may act with respect to the
power of attorney granted hereunder to protect its rights.

         (p) The proceeds of any Collateral obtained pursuant to the exercise of
any remedy set forth in this Security and Loan Agreement shall be applied
reasonably promptly by Secured Party and Liquidator:

                                       8
<PAGE>

                  First, to the payment of all costs and expenses, fees,
commissions and taxes of such sale, collection or other realization, including,
without limitation, compensation to the Liquidator and actual attorneys' fees of
Liquidator and Secured Party, together with interest on each such amount at the
highest rate then in effect under this Security and Loan Agreement;

                  Second, to the indefeasible payment in full in cash of the
Obligations, ratably according to the unpaid amounts thereof, without ;reference
or priority of any kind among amounts so due and payable; and

                  Third, to Debtor, or its successors or assigns, or to
whomsoever may be lawfully entitled to receive the same or as a court of
competent jurisdiction may direct, of any surplus then remaining from such
proceeds.

With regard to all of the rights, prerogatives, entitlements and remedies of
Secured Party for itself or Liquidator, as agent for Secured Party hereunder,
Debtor agrees that such parties may exercise all rights under this Security
Agreement without regard for the actual or potential tax consequences to Debtor
under federal or state law, without regard to any other limitations imposed or
proscribed and without regard to any instructions or directives given Secured
Party or Liquidator by Debtor.

         10. Due Authority - Resolutions - Approval. Debtor further represents
and warrants as follows:

         (a) Negotiation and Execution. Both the negotiation of the Commitment
Letter and all of the Loan Documents, as well as the execution thereof, has been
duly authorized by the Board of Directors of Debtor as evidenced by the
Certified Board Resolution attached hereto as Exhibit "B".

         (b) True, Complete and Accurate Copies of Exhibits. True, complete and
accurate copies of the following exhibits, documents, certificates, instruments
and lists are attached hereto, to wit:

                  o        Exhibit "A" - Description of Collateral
                  o        Exhibit "B" - Resolutions
                  o        Exhibit "C" - (Complete) Certified Copy of Articles
                           of Incorporation of Debtor from the Secretary of
                           State of the State of Delaware;
                  o        Exhibit "D" - Good Standing Certificate from the
                           Secretary of State of Delaware;
                  o        Exhibit "E" - Articles of Foreign Corporation from
                           the Maryland State Department of Assessments &
                           Taxation ("MD-SDAT");
                  o        Exhibit "F" - Certificate of Good Standing from
                           MD-SDAT;
                  o        Exhibit "G" - Debtor's By-Laws;
                  o        Exhibit "H" - Sample Stock Certificates and
                  o        Exhibit "I"- description of limitations and
                           prerogatives of all classes of stock;
                  o        Exhibit "J" - current financial statement and
                  o        Exhibit "K" - listing of all accounts payable and
                           debts, Payables, loans term, credit line and
                           otherwise
                  o        Exhibit "L" - listing of all "Other Obligations" of
                           Debtor.

                                       9
<PAGE>

                  o        Exhibit "M" - "Adverse Claims"

         11. Special Notices to be Given. Any notice of sale, disposition or
other action by Secured Party required by law and sent to Debtor at Debtor's
address shown below at least five (5) days prior to such action, shall
constitute reasonable notice to Debtor. Notice shall be deemed given or sent
when mailed postage prepaid to Debtor's address as provided herein and
irrespective of whether delivery is accepted by certified mail, postage prepaid
or by hand delivery or by any nationally-recognized next-day delivery service or
otherwise as permitted by applicable law. Collateral that is subject to rapid
declines in value and is customarily sold in recognized markets may be disposed
of by Secured Party in a recognized market for such collateral without providing
notice of sale. Debtor waives any and all requirements that the Secured Party
sell or dispose of all or any part of the Collateral at any particular time,
regardless of whether Debtor has requested such sale or disposition.

         12. Remedies Cumulative. No failure on the part of Secured Party to
exercise, and no delay in exercising, any right, power or remedy hereunder shall
operate as a waiver thereof, nor shall any single or partial exercise by Secured
Party or any right, power or remedy hereunder preclude any other or further
exercise thereof or the exercise of any right, power or remedy. The remedies
herein provided are cumulative and are not exclusive of any remedies provided by
law, in equity, or in other Loan Documents.

         13. Indemnification of Secured Party by Debtor. Debtor shall indemnify
and save harmless Secured Party and said party's agents, attorneys, officers,
equity holders and affiliates (including Warren & Lewis Investment Corporation
and its owners and affiliates and attorneys), singularly and jointly, from all
actual costs and expenses, including actual attorneys' fees, incurred by them or
any of them by reason of this Security Agreement, including any legal action to
which Secured Party shall or may become a party. Any money so paid or expended
by Secured Party shall be due and payable upon demand together with interest at
the Penalty Rate at the rate set forth in the Note from the date incurred and
shall be secured by this Security Agreement.

         14. Enforcement and Interpretation. At the option of Secured Party,
matters of enforcement and interpretation of this instrument or any of the Loan
Documents, whether by claim, counterclaim or otherwise, may be interpreted
solely by arbitration conducted within fifty (50) miles of the office of the
Secured Party under the general commercial arbitration rules then-applicable of
the American Arbitration Association. Arbitration shall be conducted by a panel
of three (3) arbitrators, one of whom shall be selected from among a panel
suggested by the AAA by each party and the third of whom shall be selected by
the two (2) designees so selected. Any party failing to designate his designee
within fifteen (15) days of the date requested by the AAA shall forfeit its
right to designate his designee and the designee timely designated shall appoint
the recalcitrant party's designee. No arbitrator shall serve unless said party
is an attorney currently practicing law in the State of Maryland and having
experience in matters relative to secured banking transactions in which
intellectual property is pledged as security over a period of not less than ten
(10) years. Enforcement shall be under the laws of the Jurisdiction or any other
venue which shall have subject matter jurisdiction over the matter.
Notwithstanding any rule of law to the contrary, before Debtor may institute any
counterclaim to any action against Secured Party or any third party claim
against any third party, it shall have posted a bond reasonably acceptable to
Secured Party with the AAA to bond off and otherwise to protect Secured Party
hereunder. All costs of the arbitration shall be borne by the party deemed to be
the "non-prevailing party" but the cost, expense and fees to litigate shall be
allocated as otherwise provided hereunder. The panel of arbitrators shall
schedule the trial within thirty (30) days of their appointment and they shall
render their decision within thirty (30) days of the last day of such trial,
provided that, in the event a party petitions for an Emergency Arbitration, the
above-proscribed time periods shall be reduced as provided for the Schedule of
Emergency Arbitration.

                                       10
<PAGE>

         15. Designation of Agent for Service of Process Purposes. Any matter
requiring service of process shall be served upon the Designated Agent; if said
Designated Agent shall refuse to accept service of process, the posting of the
service on the door of the Designated Agent's office shall be sufficient if
accompanied by an affidavit by the process server of compliance herewith.

             16. Definitions. The following shall have the following meanings:
(a) "Loan Documents" refers to all documents, including this Security Agreement,
whether now or hereafter existing, executed in connection with or related to the
Obligations, and may include, without limitation and whether executed by Debtor
or others, commitment letters that survive closing, loan agreements, convertible
notes, other security agreements, security instruments, financing statements,
chattel mortgage instruments and any renewals or modifications, whenever any of
the foregoing are executed. (b) "UCC" means the Uniform Commercial Code as
presently and hereafter enacted in the Jurisdiction. Any term used in this
Agreement and in any financing statement filed in connection herewith which is
defined in the UCC and not otherwise defined in this Agreement or any other Loan
Document has the meaning given to the term in the UCC. (c) "Loan" means the loan
to be advanced under the Commitment Letter which was advanced and closed by the
parties this date as evidenced by the Note and which was made pursuant to the
Loan Documents. (d) "Obligations" means all obligations, funds and impositions
due and owing under any of the Loan Documents, including, but not limited to
principal under the Note, interests, Costs and Expenses, impositions, fees,
advances made pursuant to any of the Loan Documents by Secured Party, resulting
from any remedy or right or prerogative or otherwise which arise under any of
the Loan Documents, any charges and impositions and otherwise due under any of
the foregoing. (e) "Note" means the Note defined on page one hereof and executed
of even date herewith. (f) "Jurisdiction" means the State of Maryland. (g)
"Designated Agent" means the party whose name and address appears on the
signature page hereof. (h) The term "Costs and Expenses" means all actual costs,
expenses, fees and actual impositions that a party may accrue or pay relative to
this Agreement and the enforcement of any term, condition or provision of this
instrument or any of the Loan Documents. (i) "Other Obligations" means any of
the obligations listed to any party designated on Exhibit "L". (j) "Adverse
Claims" means any claim, public or private, whether of public record or
otherwise, which has any adverse impact upon the underwriting and risk by
Security Party with respect to the Loan, the Obligations or otherwise with
respect to the transactions made between the parties or otherwise the risk of
any loss to Secured Party. (k) "Liquidator" means any party selected from among
the list attached hereto as Exhibit "N." In the absence of a party to agree at
such time to be the designated "Liquidator," then the parties shall agree upon
the designated Liquidator within fifteen (15) days upon demand by Secured Party
to do so, time being of the essence, neither party unreasonably withholding,
delaying or denying its consent and after lapse of such period, the matter shall
be submitted to arbitration hereunder using the Expedited Schedule of
Arbitration. (l) "Collateral" means the item of Collateral described on Exhibit
"A". (m) INTENTIONALLY OMITTED. (n) INTENTIONALLY OMITTED. (o) "Accounts" means
as such term is defined in the UCC with respect to any of the Collateral or
other secured given hereunder. (p) "Schedule of Emergency Arbitration" means
that all time periods otherwise scheduled for arbitration hereunder shall be
reduced as follows: (i) with regard to any matter to acted upon within fifteen
(15) days, the time period shall be reduced to three (3) days and (ii) with
respect to any matter to be acted upon within thirty (30) days, the time period
shall be reduced to five (5) days. (q) "Emergency Arbitration" shall mean any
matter relative to either (i) Liquidator's or Secured Party's rights hereunder
as a result of an actual default having been declared by Secured Party under
this Agreement or under any of the other Loan Documents or (ii) any other matter
to which a party has certified, supported by an opinion of its counsel, that the
time periods otherwise proscribed hereunder cannot wait for the periods
otherwise provided due to an emergency, provided however that with regard to any
matter petitioned under clause (ii) hereof. (r ) "Senior Lienors" means any
bank, savings and loan or similar lending institution, equipment lessor, or
accounts receivable-based lender, that has or may hereafter extend line of
credit or equipment financing or similar financing to Debtor, provided that, in
doing so, the value of the collateral is not impaired. (s) "Senior Lien
Instruments" means agreements entered into between the Debtor and the Senior
Lienors, and all collateral documentation of such transactions.

                                       11
<PAGE>

            17. Waiver of Trial By Jury. THE UNDERSIGNED PARTIES COVENANT AND
AGREE NOT TO ELECT A TRIAL BY JURY OF ANY ISSUE TRIABLE OF RIGHT BY A JURY WITH
RESPECT TO THIS DOCUMENT AND ALL OF THE OTHER LOAN DOCUMENTS, AND WAIVES ANY
RIGHT TO TRIAL BY JURY FULLY TO THE EXTENT THAT ANY SUCH RIGHT SHALL NOW OR
HEREAFTER EXIST. THIS WAIVER OF RIGHT TO TRIAL BY JURY IS SEPARATELY GIVEN,
KNOWINGLY AND VOLUNTARILY, BY EACH PARTY TO THIS INSTRUMENT, AND THIS WAIVER IS
INTENDED TO ENCOMPASS INDIVIDUALLY EACH INSTANCE AND EACH ISSUE AS TO WHICH THE
RIGHT TO A JURY TRIAL WOULD OTHERWISE ACCRUE. THE PARTY TO THIS INSTRUMENT IS
HEREBY AUTHORIZED AND REQUESTED TO SUBMIT THIS INSTRUMENT TO ANY COURT HAVING
JURISDICTION OVER THE SUBJECT MATTER AND THE PARTIES HERETO, SO AS TO SERVE AS
CONCLUSIVE EVIDENCE OF THE WAIVER OF THE RIGHT TO JURY TRIAL. FURTHER, EACH
PARTY TO THIS INSTRUMENT HEREBY CERTIFIES THAT NO REPRESENTATIVE OR AGENT OF THE
OTHER PARTY (INCLUDING ITS COUNSEL) HAS REPRESENTED, EXPRESSLY OR OTHERWISE,
THAT IT WILL NOT SEEK TO ENFORCE THIS WAIVER OF RIGHT TO JURY TRIAL PROVISION.

         18. Confession of Judgment Provisions. THE MAKER HEREBY IRREVOCABLY
CONSTITUTES AND APPOINTS (WHICH APPOINTMENT SHALL BE DEEMED TO BE COUPLED WITH
AN INTEREST) RANDY ALAN WEISS OR HIS DESIGNEE, AN ATTORNEY ADMITTED TO PRACTICE
BEFORE THE COURTS OF THE STATE OF MARYLAND, AS THE MAKER'S TRUE AND LAWFUL
ATTORNEY IN FACT, TO APPEAR FOR THE MAKER BEFORE THE CLERK OF THE CIRCUIT COURT
OF MONTGOMERY COUNTY, MARYLAND OR THE TRIAL OR SUPERIOR COURT OF ANY COUNTY IN
SAID STATE OF MARYLAND OR THE STATE OF DELAWARE OR ANY FEDERAL DISTRICT COURT
(EACH, THE "CONFESSION JURISDICTION") AND AFTER ONE OR MORE DECLARATIONS FILED,
CONFESS JUDGMENT AGAINST THE MAKER AS OF ANY TIME AFTER ANY SUM IS DUE HEREUNDER
(WHETHER BY DEMAND, STATED MATURITY, ACCELERATION OR OTHERWISE) FOR THE UNPAID
BALANCE OF THIS NOTE AND INTEREST, WITH COURT COSTS, EXPENSES DUE HEREON AND
FIFTEEN PERCENT (15%) ATTORNEY'S FEES FOR COLLECTION AND RELEASE ALL ERRORS,
WITHOUT STAY OF EXECUTION, AND INQUISITION AND EXTENSION UPON ANY LEVY ON REAL
ESTATE IS HEREBY WAIVED AND CONDEMNATION AGREED TO, AND THE EXEMPTION OF
PERSONAL PROPERTY FROM LEVY AND SALE IS ALSO HEREBY EXPRESSLY WAIVED AND NO
BENEFIT OF EXEMPTION SHALL BE CLAIMED UNDER ANY EXEMPTION LAW NOW IN FORCE OR
WHICH MAY BE HEREAFTER ADOPTED. MAKER CONSENTS TO VENUE IN THE CONFESSION
JURISDICTION WITH RESPECT TO THE INSTITUTION OF AN ACTION CONFESSING JUDGMENT
HEREON, REGARDLESS OF WHERE VENUE WOULD OTHERWISE BE PROPER. ANY JUDGMENT
ENTERED AGAINST MAKER, WHETHER BY CONFESSION OR OTHERWISE, SHALL BEAR INTEREST
AT A RATE WHICH IS THE HIGHEST RATE OF INTEREST BEING PAID BY MAKER ON THE DATE
OF JUDGMENT. THE AUTHORITY AND POWER TO APPEAR FOR AND ENTER JUDGMENT AGAINST
MAKER SHALL NOT BE EXHAUSTED BY ONE OR MORE EXERCISES THEREOF, OR BY ANY
IMPERFECT EXERCISE THEREOF, AND SHALL NOT BE EXTINGUISHED BY ANY JUDGMENT
ENTERED PURSUANT THERETO; SUCH AUTHORITY AND POWER MAY BE EXERCISED ON ONE OR
MORE OCCASIONS, FROM TIME TO TIME, IN THE SAME OR DIFFERENT JURISDICTIONS AS
OFTEN AS THE PAYEE OR ITS ASSIGNS SHALL DEEM NECESSARY OR ADVISABLE UNTIL ALL
SUMS DUE HEREUNDER HAVE BEEN PAID IN FULL.

                                       12
<PAGE>

         19. Miscellaneous Provisions. No waiver, amendment or modification of
any provision of this Security Agreement shall be valid unless in writing and
signed by Debtor and an officer of Secured Party. No waiver by Secured Party of
any Default shall operate as a waiver of any other Default or of the same
Default on a future occasion. All rights of Secured Party hereunder are freely
assignable, in whole or in part, and shall inure to the benefit of and be
enforceable by Secured Party, its successors, assigns and affiliates. Debtor may
not assign its obligations to any person, party or entity, whether affiliated or
otherwise with Debtor hereunder without the prior written consent of Secured
Party and any attempt by Debtor to assign without Secured Party's prior written
consent is null and void; provided, however, that Debtor may assign this
Security and Lien Agreement, and all of its rights and obligations hereunder,
without secured Party's written consent in connection with a Permitted
Reorganization. No assignment, other than in connection with a Permitted
Reorganization, shall release Debtor from its obligations hereunder. Time shall
be strictly of the essence with respect to each and every term, condition and
provision of all of the Loan Documents. Debtor consents to the laws of the
Jurisdiction or wherever it shall have assets or does business. Debtor agrees
that venue may lie in the United States Federal Court for either the State of
Maryland or the State of Delaware or any local court therein, the defense under
the doctrine of forum non-conveniens being waived. All rights, powers, and
remedies of Secured Party provided for in the Loan Documents are cumulative and
concurrent and shall be in addition to and not exclusive of any appropriate
legal or equitable remedy provided by Law or contract. Exercise of any right,
power, or remedy shall not preclude the simultaneous or subsequent exercise of
any other by the Secured Party. The terms, conditions and provisions of the
Commitment Letter shall survive the closing of the Loan and not be merged
therein. This Security Agreement shall be binding upon Debtor, and the heirs,
personal representatives, successors, and assigns of Debtor. This Security
Agreement shall be governed by and construed under the laws of the Jurisdiction
without regard to that Jurisdiction's conflict of laws principles, except to the
extent that the Uniform Commercial Code requires the application of the law of a
different jurisdiction. If any terms of this Security Agreement conflict with
the terms of any commitment letter or loan proposal, the terms of this Security
Agreement shall control. Debtor irrevocably agrees to non-exclusive personal
jurisdiction in the Jurisdiction. If any provision of this Security Agreement
shall be prohibited by or invalid under applicable law, such provision shall be
ineffective but only to the extent of such prohibition or invalidity, without
invalidating the remainder of such provision or the remaining provisions of this
Security Agreement. Any notices to Debtor shall be sufficiently given, if in
writing and mailed or delivered to the address of Debtor shown above or such
other address as provided hereunder and to Secured Party, if in writing and
mailed or delivered to Secured Party's office address shown below such party's
signature or such other address as Secured Party may specify in writing from
time to time. In the event that Debtor changes Debtor's mailing address at any
time prior to the date the Obligations are paid in full, Debtor agrees to
promptly give written notice of said change of address by registered or
certified mail, return receipt requested, all charges prepaid. The parties waive
the doctrine of contra proferentem for purposes of all of the Loan Documents.
This Agreement may be signed in counterpart, which, when fully assembled, shall
constitute one complete instrument. Notwithstanding any rule of law nor any
action or representation to the contrary, whenever the discretion or prerogative
of Secured Party shall be given or granted, the same shall be as Secured Party
shall determine in its sole and absolute discretion and not under any objective
standard. The captions contained herein are inserted for convenience only and
shall not affect the meaning or interpretation of this Security Agreement or any
provision hereof. The use of the plural shall also mean the singular, and vice
versa. Debtor, by execution and Secured Party by acceptance of this Security
Agreement, agrees it is bound by all terms and provisions of this Security
Agreement.

                                       13
<PAGE>

         In witness whereof, the undersigned have set their hand and seal
effective on the date first set forth above.

                                       14
<PAGE>

SECURED PARTY:                 Private Investors Equity, LLC

                               By: /s/
                                  ----------------------------------------------
                               Title:
                                     -------------------------------------------
                               Address for Notices:
                               c/o Private Consulting Group, Inc.
                               4650 SW Macadam Avenue, Suite #400
                               Portland, OR  97201  Attn: David Fitzpatrick, EVP

DEBTOR:                        InforMedix, Inc.

                               By:/s/
                                  ----------------------------------------------
                               Title:
                                     -------------------------------------------

                               Attest by:/s/
                                         ---------------------------------------
                                         Its Secretary                      SEAL
                               Address for Notices:
                               5880 Hubbard Drive, Rockville, MD 20852

                               Designated Party for InforMedix, Inc. Means:

                               -------------------------------------------------

                               whose address is at:
                                                    ----------------------------

                               -------------------------------------------------

                               InforMedix Acquisition Corp.

                               By:/s/
                                  ----------------------------------------------
                               Title:
                                     -------------------------------------------

                               Attest by:/s/
                                         ---------------------------------------
                                         Its Secretary                      SEAL
                               Address for Notices:
                               5880 Hubbard Drive, Rockville, MD 20852

                               Designated Party for InforMedix, Inc. Means:

                               -------------------------------------------------

                               whose address is
                                                 -------------------------------

                               -------------------------------------------------

                                       15
<PAGE>

                    Exhibit "A" - Description of Collateral,
          Including a copy of description of all intellectual property,
       The Patent & License Exchange dated January 16, 2002 and otherwise

     A.    All patents, patent applications and patentable inventions,
           including, without limitation, the Debtor's Pioneer Patent Portfolio,
           each such patent being identified in Schedule 1 to this Exhibit "A"
           attached hereto and made a part hereof and each patent application
           identified in such Schedule 1 including, without limitation, all
           inventions and improvements described and claimed therein and the
           right to make, use or sell the same, the right to sue or otherwise
           recover for any misappropriations thereof, all income, royalties,
           damages and other payments now and hereafter due and/or payable with
           respect thereto (including, without limitation, payments under all
           licenses entered into in connection therewith, and damages and
           payments for past and future infringements thereof), and all rights
           corresponding thereto throughout the world and all reissues,
           divisions, continuations, continuations-in-part, substitutes,
           renewals and extensions thereof, all improvements thereon and all
           other rights of any kind whatsoever of each Grantor accruing
           hereunder or pertaining thereto ("Patents").

           B. All license agreements (subject to the rights of the other parties
           thereto) with any other person in connection with any of the Patents,
           or such other person's patents, trade names, trademarks, service
           marks, copyrights or works of authorship, or other intellectual
           property, whether such grantor is a licensor or licensee under any
           such license agreement, including, without limitation, the license
           agreements listed on Schedule 2 attached hereto and made a part
           hereof, and any right to prepare for sale, sell and advertise for
           sale, all goods and/or services now or hereafter owned by the Debtor
           and now or hereafter covered by any such licenses ("Licenses");
           provided, however, that to the extent that the consent of any other
           party to any of the Licenses is required, under the terms thereof,
           for the collateral assignment thereof, the Security and Loan
           Agreement shall not effect any collateral assignment of (or otherwise
           be applied so as to cause a default under) such Licenses.

           C. All proceeds of the Accounts, Patents and Licenses, including,
           without limitation, all claims by Debtor against third parties for
           infringement of the Patents or Licenses ("Proceeds").

                                       16
<PAGE>

THIS NOTE AND THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER
THE SECURITIES ACT OF 1933, AS AMENDED, OR ANY APPLICABLE STATE SECURITIES LAW,
AND HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO, OR IN CONNECTION
WITH, THE SALE OR DISTRIBUTION THEREOF. NO SUCH SALE OR DISTRIBUTION MAY BE
EFFECTED WITHOUT AN EFFECTIVE REGISTRATION STATEMENT RELATED THERETO OR AN
OPINION OF COUNSEL IN A FORM SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION
IS NOT REQUIRED.

                       SECURED CONVERTIBLE PROMISSORY NOTE
                             WITH DETACHABLE WARRANT

$350,000.00                                                     November 4, 2002
                                                     Montgomery County, Maryland

For value received and pursuant to the terms of that certain "Security and Loan
Agreement" made this date, InforMedix Acquisition Corp., a Delaware Corporation
("IMAC") and its wholly-owned subsidiary, InforMedix, Inc., a Delaware
corporation ("IMI"), their assigns and successors in interest (collectively, the
"Company"), promises to pay Private Investors Equity, LLC, or order, and any
successors, transferees and assignees thereof (together, "Holder"), the
principal sum of three-hundred fifty thousand dollars ($350,000.00), plus
interest, Costs and Expenses, impositions, charges and fees or any other expense
accruing and entitled pursuant to the terms hereof. This Note evidences the loan
("Loan") made by the Holder this date unto the Company and is subject to the
following terms and conditions:

1.       Term. The term of this Note shall mature ("Maturity Date") on the
         earlier of (i) the date which is six (6) months from the date hereof,
         or (ii) or the date on which any Financing Event(s) is closed or (iii)
         any other date on which any principal amount of, or accrued unpaid
         interest on, this Note becomes, due and payable pursuant to its terms
         prior to its natural maturity. The term "Financing Event(s)" means any
         date(s) on which debt or equity financing or other funding is secured,
         cumulatively, commencing on the date hereof and subsequent to the date
         hereof, in the cumulative total of $1,000,000 or more (excluding all
         funds advanced under this Note).

                                        1
<PAGE>

2.       Conversion. (a) Investment by Holder. The entire principal amount and
         the accrued interest as well as any costs, fees and expenses having
         accrued and all Costs and Expenses relative to this Note or any of the
         Loan Documents, or any portion thereof, may be converted, if the Holder
         so elects in writing to the Company, at any time prior to receipt of
         full payment made, into shares of the Company's common stock ("Common
         Stock"). Holder may make the foregoing election to convert on one (1)
         occasion only. The number of shares of Common Stock to be issued to the
         Holder upon such conversion shall be equal to the number of shares
         derived by the quotient obtained by dividing the outstanding principal
         balance and accrued interest, together with any expenses, accruals,
         fees or impositions, Costs and Expenses and otherwise on this Note by
         one dollar ($1.00) ("Price Per Share"). The Price Per Share shall be
         adjusted upon the occurrence of the events described in and in the
         manner provided for adjustment to the warrant exercise price in Section
         2 of Exhibit A hereto. (b) Mechanics and Effect of Conversion. No
         fractional shares of the Company's capital stock will be issued upon
         conversion of this Note and the accrued interest balance. In lieu of
         any fractional share to which the Holder would otherwise be entitled,
         upon full conversion of this Note, the Company will pay to the Holder,
         in cash, the amount of the unconverted principal and accrued interest
         balance, together with any Costs and Expenses relative to this Note.
         The Holder shall surrender this Note, duly endorsed, at the principal
         offices of the Company or any transfer agent of the Company, and shall
         give written notice to the Company ("Exercise Notice") of the election
         to convert same or the portion to be converted and shall state therein
         the name or names in which the certificate or certificates for the
         securities acquired hereunder are to be issued. At its expense, the
         Company will, as soon as practicable thereafter but not later than five
         (5) days therefrom, issue and deliver to such Holder, at such principal
         office, a certificate or certificates for the number of shares to which
         such Holder is entitled upon such conversion, together with any other
         securities and property to which the Holder is entitled upon such
         conversion under the terms of this Note, including a check payable to
         the Holder for any cash amounts payable as described herein. Upon
         conversion of this Note, and accrued interest balance, the Company will
         be forever released from all of its obligations and liabilities under
         this Note with regard to that portion of the principal amount being
         converted included, without limitation, the obligation to pay future
         interest on such portion of the principal amount.

3.       Interest. Interest shall accrue from the effective date of this Note
         ("Note Date") until repayment of the Note on the unpaid principal
         amount computed on the basis of a 360-day year and the actual number of
         days elapsed. Interest shall be payable at a rate equal to twelve
         percent (12.0%) per annum until the Note is repaid in full.
         Notwithstanding anything to the contrary herein contained, repayment
         under the preceding sentence shall be paid in preference to repayment
         thereof and prior to the payment of any dividends or distributions on
         any equity security issued by the Company or any interest or principal
         on any other debt of the Company other pursuant to the Senior Lien
         Instruments.

4.       Security. To secure the full and complete performance of the
         obligations of the Company under this Note the Company hereby grants to
         the Holder, a perfected lien on all of its right, title and interest in
         and to, whether now owned or hereafter acquired (together
         "Collateral")": all of its property on Exhibit A to the Security and
         Loan Agreement. The Holder's interest in the Collateral shall be as a
         secured lender pursuant to the terms of the Security and Loan Agreement
         as publicized by one or more financing statement(s) dated of even date
         with subject only to Senior Lien Instruments as such term is defined in
         the Security and Loan Agreement of even date herewith.

                                       2
<PAGE>

5.       Payment. (a) All payments shall be made in lawful currency of the
         United States of America at such place as the Holder hereof may from
         time to time designate in writing to the Company, all payments shall be
         credited first to Costs and Expenses, fees, expenses and impositions,
         if any, then to accrued interest then due and payable and the remainder
         applied to principal, except that, after the occurrence and during the
         continuation of any default under this Note, all amounts received shall
         be applied in such order as the Holder, in its sole discretion, may
         elect. In order for a payment to be timely received as of the date
         sought to be made, it shall be received not later than 2:00pm Eastern
         Time on a Business Day and if not made by such time or on such business
         day, then it shall be deemed to be received on the next business day.
         The term "Business Day" shall mean any banking day that SunTrust Bank,
         NA is open for business and during which it may both accept and credit
         wire transfers. Prior to any payment, the Company shall provide the
         Holder at least ten (10) business days advance notice of its intention
         to make such payment. Except with respect to prepayment made at the
         Company's election in connection with a Permitted Reorganization (as
         defined in the Security and Loan Agreement), payment hereon may only be
         made in full on the Maturity Date.

6.       No Waiver. The acceptance by the Holder of any payment under this Note
         after the date that such payment is due shall not constitute a waiver
         of the right to require prompt payment when due of future or succeeding
         payments or to declare a default as herein provided for any failure to
         so pay. The acceptance by the Holder of a portion of any payment at any
         time that such payment is due and payable in its entirety shall neither
         cure nor excuse the default caused by the failure to pay the whole of
         such payment and shall not constitute a waiver of the Holder's right to
         require full payment when due of all future or succeeding payments

7.       Registration. If at any time the Company shall determine to register
         for its own account or the account of others under the Securities Act
         of 1933, as amended (including without limitation pursuant to the
         registration of any shareholder of the Company), any of its equity
         securities, other than on Form S-8 or Form S-4 or their then
         equivalents (a "Piggyback Registration"), it shall send the Holder
         written notice of such determination and, if within fifteen (15) days
         after receipt of such notice, Holder shall so request in writing, the
         Company shall use its diligent efforts to include in such registration
         statement all or any part of the shares of Common Stock or other
         securities issued or issuable upon conversion of this Note
         ("Registrable Shares") that Holder requests to be registered, except
         that if, in connection with any offering involving an underwriting of
         Common Stock to be issued by the Company the managing underwriter shall
         impose a limitation on the number of shares of Common Stock which may
         be included in the registration statement because, in its judgment,
         such limitations necessary to effect an orderly public distribution,
         then the Company shall be obligated to include in such registration
         statement only such limited portion (or none, if so required by the
         managing underwriter) of the Registrable Shares with respect to which
         such holder has requested inclusion hereunder. Except as specifically
         provided herein, all Registration Expenses incurred in connection with
         any registration under this Section shall be borne by the Company. All
         Selling Expenses incurred in connection with any registrations
         hereunder, shall be borne by the holders of the securities so
         registered pro rata on the basis of the number of shares so registered.
         For purposes of this Section, "Registration Expenses" means all
         expenses incurred by the Company in complying with this Section,
         including, without limitation, all registration and filing fees,
         printing expenses, fees and disbursements of counsel and independent
         public accountants for the company, fees and expenses of listing the
         securities with the securities exchange, fees and expenses (including
         counsel fees) incurred in connection with complying with state
         securities or "blue sky" laws, fees and expenses of one designated
         counsel for the Holder in connection with the registration of
         Registrable Shares, transfer taxes, fees of transfer agents and
         registrars, costs of any insurance which might be obtained, but
         excluding any Selling Expenses. For purposes of this Section, "Selling
         Expenses" means all underwriting discounts and selling commissions
         applicable to the sale of Registrable Shares and the fees and expenses
         of more than one counsel for the Holder in connection with the
         registration of Registrable Shares.

                                       3
<PAGE>

8.       Stock Purchase Warrants. (a) Contemporaneous with the making of this
         Note, IMAC has issued warrants ("Warrants") in connection herewith to
         purchase from IMAC , at any time on or before the fifth anniversary of
         the Note date, shares of IMAC's Common Stock at an exercise price of
         one dollar and fifty cents ($1.50) per share ("Warrant Exercise
         Price"). The Warrants may be exercised by the holder, in whole only,
         with the purchase form appended to the Warrant duly executed by the
         holder at the principal office of IMAC, or at such other office or
         agency as IMAC may designate, accompanied by payment in full of the
         purchase price as set forth herein. (b) A certificate representing the
         warrant fully executed by IMAC, shall be delivered to the holder upon
         the making of the Note.

9.       Transfer; Successors and Assigns. The terms and conditions of this Note
         shall inure to the benefit of and be binding upon the respective heirs,
         successors and assigns of the parties. Notwithstanding the foregoing,
         the Company may not assign, pledge or otherwise transfer this Note
         without the prior written consent of the Holder. Subject to the
         preceding sentence, this Note may be transferred by the Company only
         upon surrender of the original Note for registration of transfer, duly
         endorsed, or accompanied by a duly executed written instrument of
         transfer in terms satisfactory to the Holder. This Note may be
         transferred by the Holder only upon surrender of the original Note for
         registration of transfer, duly endorsed, or accompanied by a duly
         executed written instrument of transfer, a form of which has been given
         to the Holder. Thereupon, a new note for the same principal amount and
         interest will be issued to, and registered in the name of, the
         transferee. Interest and principal are payable only to the registered
         Holder of this Note.

10.      Attorneys' Fees and Costs and Expenses. In the event it becomes
         necessary for the Holder to utilize legal counsel for the enforcement
         of this Note or any of the other of the Loan Documents or any of said
         terms, and, irrespective of whether or not suit is filed or otherwise,
         the Company shall pay or reimburse as the case may be, on demand, the
         Holder immediately for all of the Holder's accrued attorney's fees and
         other Costs and Expenses; Company shall likewise pay Holder on demand
         for any of the foregoing incurred in connection with the representation
         of the Holder in any bankruptcy, insolvency, reorganization or other
         debtor-relief or similar proceeding of or relating to the Company.

                                       4
<PAGE>

11.      Waivers; Time. The maker of this Note hereby waives diligence, demand,
         presentment, notice of non-payment or dishonor, protest and notice of
         protest, and expressly agrees that the time for performance of any
         obligation under this Note may be extended from time to time, and
         consents to the release of any party liable hereon or herefor, consents
         to the acceptance of further security for this Note, including other
         types of security, all without in any way affecting liability, and
         waives the right to plead any and all statutes of limitations as a
         defense to any demand on this Note, or to any agreements to pay the
         same, to the fullest extent permissible by law. Time is strictly of the
         essence with respect to all terms, condition and provisions hereof.

12.      Governing Law. This Note and all acts and transactions pursuant hereto
         and the rights and obligations of the parties hereto shall be governed,
         construed and interpreted in accordance with the laws of the State of
         Maryland, without giving effect to principles of conflicts of law.

13.      Severability. Every provision hereof is intended to be severable. If
         any provision of this Note is determined by a court of competent
         jurisdiction to be illegal, invalid or unenforceable, such illegality,
         invalidity or unenforceability shall not affect the other provisions
         hereof, which shall remain binding and enforceable.

14.      Notices. Any notice required by this Note shall be in writing and shall
         be deemed sufficient when delivered personally or by a nationally
         recognized delivery service (such as Federal Express or UPS) or when
         delivery is attempted to be made and addressed to the party to be
         notified at such party's address as set forth below or as subsequently
         modified by written notice. No notice need be given if payment is due
         on the Maturity Date.

15.      Amendments and Waivers. Any term of this Note may be amended only with
         the mutual written consent of the Company and the Holder. Any amendment
         or waiver effected in accordance with this Section shall be binding
         upon the Company, the Holder and each transferee of the Note.

16.      Securities Act of 1933. Upon conversion of this Note, the persons
         entitled to receive the securities may be required to execute and
         deliver to the Company an instrument, in form satisfactory to the
         Company, representing that such person is an accredited investor as
         defined in Securities and Exchange Commission Rule 501(a) under the
         Securities Act of 1933, as amended (the "Act") and the securities are
         being acquired for investment, and not with a view to distribution,
         within the meaning of the Act.

17.      Shareholder Status. Nothing contained in this Note shall be construed
         as conferring upon the Holder the right to vote or to receive dividends
         or to consent, or any rights whatsoever as a shareholder of the Company
         prior to conversion hereof.

18.      Default - Penalty Rate - Acceleration. If Company fails to make any
         payment under this Note when due, or otherwise breaches (beyond any
         available notice and cure period) any obligation, term, conditions or
         provision hereunder or under any of the Loan Documents, then the entire
         principal sum, together with all accrued and unpaid interest and costs
         thereon, including any Costs and Expenses, shall at Holder's option be
         immediately due and payable. Further, upon the failure of the Company
         to comply with any of the requirements embraced herein or in any of the
         Loan Documents then, in such event and in addition to any other remedy
         the Lender may exercise, the interest rate accruing on the unpaid
         principal balance of this Note shall be increased by 500 basis points
         (5%) (said adjusted interest rate being the "Penalty Rate"), regardless
         of whether the Holder elects to accelerate the unpaid principal balance
         as a result of such default.

                                       5
<PAGE>

19.      Confession of Judgment Provisions. THE MAKER HEREBY IRREVOCABLY
         CONSTITUTES AND APPOINTS (WHICH APPOINTMENT SHALL BE DEEMED TO BE
         COUPLED WITH AN INTEREST) RANDY ALAN WEISS OR HIS DESIGNEE, AN ATTORNEY
         ADMITTED TO PRACTICE BEFORE THE COURTS OF THE STATE OF MARYLAND, AS THE
         MAKER'S TRUE AND LAWFUL ATTORNEY IN FACT, TO APPEAR FOR THE MAKER
         BEFORE THE CLERK OF THE CIRCUIT COURT OF MONTGOMERY COUNTY, MARYLAND OR
         THE TRIAL OR SUPERIOR COURT OF ANY COUNTY IN SAID STATE OF MARYLAND OR
         THE STATE OF DELAWARE OR ANY FEDERAL DISTRICT COURT (EACH, THE
         "CONFESSION JURISDICTION") AND AFTER ONE OR MORE DECLARATIONS FILED,
         CONFESS JUDGMENT AGAINST THE MAKER AS OF ANY TIME AFTER ANY SUM IS DUE
         HEREUNDER (WHETHER BY DEMAND, STATED MATURITY, ACCELERATION OR
         OTHERWISE) FOR THE UNPAID BALANCE OF THIS NOTE AND INTEREST, WITH COURT
         COSTS, EXPENSES DUE HEREON AND FIFTEEN PERCENT (15%) ATTORNEY'S FEES
         FOR COLLECTION AND RELEASE ALL ERRORS, WITHOUT STAY OF EXECUTION, AND
         INQUISITION AND EXTENSION UPON ANY LEVY ON REAL ESTATE IS HEREBY WAIVED
         AND CONDEMNATION AGREED TO, AND THE EXEMPTION OF PERSONAL PROPERTY FROM
         LEVY AND SALE IS ALSO HEREBY EXPRESSLY WAIVED AND NO BENEFIT OF
         EXEMPTION SHALL BE CLAIMED UNDER ANY EXEMPTION LAW NOW IN FORCE OR
         WHICH MAY BE HEREAFTER ADOPTED. MAKER CONSENTS TO VENUE IN THE
         CONFESSION JURISDICTION WITH RESPECT TO THE INSTITUTION OF AN ACTION
         CONFESSING JUDGMENT HEREON, REGARDLESS OF WHERE VENUE WOULD OTHERWISE
         BE PROPER. ANY JUDGMENT ENTERED AGAINST MAKER, WHETHER BY CONFESSION OR
         OTHERWISE, SHALL BEAR INTEREST AT A RATE WHICH IS THE HIGHEST RATE OF
         INTEREST BEING PAID BY MAKER ON THE DATE OF JUDGMENT. THE AUTHORITY AND
         POWER TO APPEAR FOR AND ENTER JUDGMENT AGAINST MAKER SHALL NOT BE
         EXHAUSTED BY ONE OR MORE EXERCISES THEREOF, OR BY ANY IMPERFECT
         EXERCISE THEREOF, AND SHALL NOT BE EXTINGUISHED BY ANY JUDGMENT ENTERED
         PURSUANT THERETO; SUCH AUTHORITY AND POWER MAY BE EXERCISED ON ONE OR
         MORE OCCASIONS, FROM TIME TO TIME, IN THE SAME OR DIFFERENT
         JURISDICTIONS AS OFTEN AS THE PAYEE OR ITS ASSIGNS SHALL DEEM NECESSARY
         OR ADVISABLE UNTIL ALL SUMS DUE HEREUNDER HAVE BEEN PAID IN FULL.

                                       6
<PAGE>

20.      Definitions - Construction - Enforcement - Miscellany. The term "Loan
         Documents" shall mean any instrument, agreement or writing relative to
         the credit extended as evidenced by this instrument, including but not
         limited to the following documents executed of even date herewith:
         Security and Loan Agreement, Financing Statement(s), Warrants and any
         other agreement in writing executed on or after the date hereof. Except
         as may be specifically provided for in the Loan Documents, no terms,
         condition or provision shall survive the closing of the Loan and the
         Loan Documents, all of the same being merged therein. Any other defined
         term herein shall be defined consistent with the terms of any of the
         other Loan Documents. The term "Costs and Expenses" shall mean all
         costs, expenses, fees and actual impositions that Holder may accrue or
         pay relative to the enforcement of any term, condition or provision of
         this Note or any of the Loan Documents. Construction and enforcement of
         this instrument or under any of the other of the Loan Documents shall
         be, at the option of the Holder, pursuant to this instrument or any of
         the other of the Loan Documents or relative to enforcement or
         litigation pursuant to or relative to arbitration or court action
         pursuant to the Loan Documents References to the singular, plural and
         gender shall be read as the context shall plainly require. Paragraphs
         and juxtaposition is purely for convenience sake and no particular
         meaning shall be ascribed thereto. The Company represents and warrants
         that the proceeds of the loan evidenced by this instrument are for
         business and mercantile purposes and not for personal or consumer
         purposes and thereby exempt from all usury limitations under applicable
         law. All terms, conditions and provisions of all of the other Loan
         Documents, including, but not limited to the Security and Loan
         Agreement, to the extent such provisions are not inconsistent herewith,
         are incorporated herein by this reference and any remedies or
         provisions of the Holder hereof are likewise incorporated herein such
         that the Holder may exercise such other remedies. This instrument may
         be signed in counterpart which, when fully assembled, shall constitute
         one instrument. The doctrine of contra proferentem shall not apply to
         this instrument or any of the other of the Loan Documents. This Note is
         made under seal.

         Made on November 4, 2002 under seal in Montgomery County, Maryland.

MAKER:

INFORMEDIX, INC.

By: /s/
   -----------------------------------------------------
Name:
        ------------------------------------------------
Title:
        ------------------------------------------------
Address for notices: 5880 Hubbard Drive, Rockville, MD 20852

Attest:  /s/
       -------------------------------------------------
         SECRETARY                                Seal

                                       7
<PAGE>

INFORMEDIX ACQUISITION CORP.

By: /s/
   -----------------------------------------------------
Name:
        ------------------------------------------------
Title:
        ------------------------------------------------
Address for notices: 5880 Hubbard Drive, Rockville, MD 20852

Attest:  /s/
       -------------------------------------------------
         SECRETARY                                Seal

                                       8
<PAGE>

HOLDER:

PRIVATE INVESTORS EQUITY, LLC

By: /s/
   --------------------------------------------------
Name:
     ------------------------------------------------
Title:
      -----------------------------------------------
Address for Notices:
c/o Private Consulting Group, Inc.
4650 SW Macadam Avenue, Suite #400, Portland, OR  97201
Attn:  David Fitzpatrick, EVP

                                       9
<PAGE>

THE SECURITIES REPRESENTED BY THIS WARRANT HAVE BEEN ACQUIRED FOR INVESTMENT AND
HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED ("1933
ACT") OR ANY STATE SECURITIES LAWS. SUCH SECURITIES MAY NOT BE SOLD OR
TRANSFERRED IN THE ABSENCE OF SUCH REGISTRATION OR AN EXEMPTION THEREFROM UNDER
THE 1933 ACT AND ANY APPLICABLE STATE SECURITIES LAWS.

                           WARRANT TO PURCHASE SHARES
                                 OF THE STOCK OF
                          informedix ACQUISITION CORP.
                  (Void after Expiration Date-November 4, 2007)

         This certifies that Private Investors Equity, LLC or its successors or
assigns ("Holder") in consideration of one cent in hand paid for each share of
the Common Stock exercised hereunder, shall be entitled to purchase from
InforMedix Acquisition Corp., a Delaware corporation ("Company"), having its
principal place of business at 5880 Hubbard Drive, Rockville, MD 20852, Seven
Hundred Thousand (700,000) shares of fully paid and nonassessable shares of the
Company's common stock ("Common Stock"), at an exercise price of one dollar and
fifty cents ($1.50) per share ("Exercise Price"). This Warrant shall be
exchangeable for shares at any time, or from time-to-time, up to and including
5:00 p.m. (local time) on the fifth anniversary from the date of this Warrant,
namely, November 4, 2007 ("Expiration Date"), upon the surrender to the Company
at its principal place of business (or at such other location as the Company may
advise the Holder in writing) of this Warrant properly endorsed with a form of
subscription in substantially the form attached hereto duly filled in and signed
and, if applicable, upon payment in cash or by check of the aggregate Exercise
Price for the number of shares for which this Warrant is being exercised
determined in accordance with the provisions hereof. The Exercise Price and the
number of shares of Common Stock purchasable hereunder are subject to adjustment
as provided in Section 2 of this Warrant.

1.  EXERCISE; ISSUANCE OF CERTIFICATES; PAYMENT FOR SHARES.

    1.1. General. This Warrant is exercisable in full on one (1) occasion only,
         at the option of the Holder of record at any time or from time, to
         time, up to the Expiration Date for all of the shares of Common Stock
         (but not for a fraction of a share) which may be purchased hereunder.
         The Company agrees that the shares of Common Stock purchased under this
         Warrant shall be and are deemed to be issued to the Holder hereof as
         the record owner of such shares as of the close of business on the date
         on which this Warrant shall have been surrendered, properly endorsed,
         the completed, executed Subscription Form (attached hereto as Exhibit
         A-1) delivered and payment made for such shares. Certificates for the
         shares of Common Stock so purchased, together with any other securities
         or property to which the Holder is entitled upon such exercise, shall
         be delivered to the Holder by the Company at the Company's expense
         within a reasonable time after the rights represented by this Warrant
         have been so exercised, and in any event, within fifteen (15) days of
         such exercise. Each Common Stock certificate so delivered shall be in
         such denominations of Common Stock as may be requested by the Holder
         hereof and shall be registered on the Company's books in the name
         designated by such Holder.

<PAGE>

    1.2. Net Issue Exercise. Notwithstanding any provisions herein to the
         contrary, if the fair market value of one share of the Company's Common
         Stock is greater than the Exercise Price (at the date of calculation as
         set forth below), in lieu of exercising this Warrant for cash, the
         Holder may elect to receive shares equal to the value (as determined
         below) of this Warrant (or the portion thereof being canceled) by
         surrender of this Warrant at the principal office of the Company
         together with the properly endorsed Form of Subscription and notice of
         such election in which event the Company shall issue to the Holder a
         number of shares of Common Stock computed using the following formula:

                                   X = Y (A-B)
                                       -------
                                          A

         Where X= the number of shares of Common Stock to be issued to the
         Holder

                  Y=       the number of shares of Common Stock purchasable
                           under the Warrant or, if only a portion of the
                           Warrant is being exercised, the portion of the
                           Warrant being canceled (at the date of such
                           calculation)

                  A=       the fair market value of one share of Common Stock
                           (at the date of such calculation)

                  B=       Exercise Price (as adjusted to the date of such
                           calculation).

         For purposes of the above calculation, the fair market value of one
         share of Common Stock shall be determined by the Company's Board of
         Directors in good faith; provided, however, that where there is a
         public market for the Common Stock, the fair market value per share
         shall be the average of the closing prices of the Common Stock quoted
         on the Bulletin Board, Nasdaq National Market (or similar system), or
         on any exchange on which the Common Stock is listed, whichever is
         applicable, over the five (5) day period ending one (1) day before the
         day the current fair market value is being determined.

    1.3. SHARES TO BE FULLY PAID; RESERVATION OF SHARES. The Company covenants
         and agrees that all shares of Common Stock which may be issued upon the
         exercise of the rights represented by this Warrant will, upon issuance,
         be duly authorized, validly issued, fully paid and nonassessable and
         free from all preemptive rights of any shareholder and free of all
         taxes, liens and charges with respect to the issue thereof. The Company
         further covenants and agrees that, during the period within which the
         rights represented by this Warrant may be exercised, the Company will
         at all times have authorized and reserved, for the purpose of issue or
         transfer upon exercise of the subscription rights evidenced by this
         Warrant, a sufficient number of shares of authorized but unissued
         Common Stock, when and as required to provide for the exercise of the
         rights represented by this Warrant. The Company will take all such
         action as may be necessary to assure that such shares of Common Stock
         may be issued as provided herein without violation of any applicable
         law or regulation, or of any requirements of any domestic securities
         exchange upon which the Common Stock or other securities may be listed;
         provided, however, that the Company shall not be required to effect a
         registration under federal or state securities laws with respect to
         such exercise. The Company will not take any action which would result
         in any adjustment of the Exercise Price (as set forth in Section 2
         hereof) if the total number of shares of Common Stock issuable after
         such action upon exercise of all outstanding warrants, together with
         all shares of Common Stock then outstanding and all shares of Common
         Stock then issuable upon exercise of all options and upon the
         conversion of all convertible securities then outstanding, would exceed
         the total number of shares of Common Stock or Equity Securities then
         authorized by the Company's Articles/Certificate of Incorporation
         ("Company Charter").

                                       2
<PAGE>

    2.   DETERMINATION OR ADJUSTMENT OF EXERCISE PRICE AND NUMBER OF SHARES. The
         Exercise Price and the number of shares purchasable upon the exercise
         of this Warrant shall be subject to adjustment from time to time upon
         the occurrence of certain events described in this Section 2. Upon each
         adjustment of the Exercise Price, the Holder of this Warrant shall
         thereafter be entitled to purchase, at the Exercise Price resulting
         from such adjustment, the number of shares obtained by multiplying the
         Exercise Price in effect immediately prior to such adjustment by the
         number of shares purchasable pursuant hereto immediately prior to such
         adjustment, and dividing the product thereof by the Exercise Price
         resulting from such adjustment. The initial number of shares
         purchasable upon the exercise of this Warrant is Seven Hundred Thousand
         (700,000) shares.

         2.1. Subdivision or Combination of Common Stock. In case the Company
         shall at any time subdivide its outstanding shares of Common Stock into
         a greater number of shares, the Exercise Price in effect immediately
         prior to such subdivision shall be proportionately reduced, and
         conversely, in case the outstanding shares of Common Stock of the
         Company shall be combined into a smaller number of shares, the Exercise
         Price in effect immediately prior to such combination shall be
         proportionately increased.

         2.2 Dividends in Common Stock, Other Stock, Property, Reclassification.
         If at any time or from time to time the holders of Common Stock (or any
         shares of stock or other securities at the time receivable upon the
         exercise of this Warrant or into which such securities are convertible)
         shall have received or become entitled to receive, without payment
         therefor,

         2.2.1.   Stock, Common Stock or any shares of stock or other securities
                  which are at any time directly or indirectly convertible into
                  or exchangeable for Common Stock, or any rights or options to
                  subscribe for, purchase or otherwise acquire any of the
                  foregoing by way of dividend or other distribution,

                                       3
<PAGE>

         2.2.2.   any cash paid or payable otherwise than as a cash dividend, or

         2.2.3.   Stock, Common Stock or additional stock or other securities or
                  property (including cash) by way of spinoff, split-up,
                  reclassification, combination of shares or similar corporate
                  rearrangement, (other than shares of Common Stock issued as a
                  stock split or adjustments in respect of which shall be
                  covered by the terms of Section 2.1 above), then and in each
                  such case, the Holder hereof shall, upon the exercise of this
                  Warrant, be entitled to receive, in addition to the number of
                  shares of Stock or Common Stock receivable thereupon, and
                  without payment of any additional consideration therefor, the
                  amount of stock and other securities and property (including
                  cash in the cases referred to in clause (2.2.2) above and this
                  clause (2.2.3)) which such Holder would hold on the date of
                  such exercise had he been the holder of record of such Common
                  Stock as of the date on which holders of Common Stock received
                  or became entitled to receive such shares or all other
                  additional stock and other securities and property.

    2.3. Reorganization, Reclassification, Consolidation, Merger or Sale. If any
         recapitalization, reclassification or reorganization of the capital
         stock of the Company, or any consolidation or merger of the Company
         with another corporation, or the sale of all or substantially all of
         its assets or other transaction shall be effected in such a way that
         holders of Common Stock shall be entitled to receive stock, securities,
         or other assets or property (an "Organic Change"), then, as a condition
         of such Organic Change, lawful and adequate provisions shall be made by
         the Company whereby the Holder hereof shall thereafter have the right,
         upon exercise of this warrant, to purchase and receive (in lieu of the
         shares of the Common Stock of the Company immediately theretofore
         purchasable and receivable upon the exercise of the rights represented
         by this Warrant) such shares of stock, securities or other assets or
         property as may be issued or payable with respect to or in exchange for
         a number of outstanding shares of such Common Stock equal to the number
         of shares of such stock immediately theretofore purchasable and
         receivable upon the exercise of the rights represented by this Warrant.
         In the event of any Organic Change, appropriate provision shall be made
         by the Company with respect to the rights and interests of the Holder
         of this Warrant to the end that the provisions hereof (including,
         without limitation, provisions for adjustments of the Exercise Price
         and of the number of shares purchasable and receivable upon the
         exercise of this Warrant) shall thereafter be applicable, in relation
         to any shares of stock, securities or assets thereafter deliverable
         upon the exercise hereof. The Company will not effect any such
         consolidation, merger or sale unless, prior to the consummation
         thereof, the successor corporation (if other than the Company)
         resulting from such consolidation or the corporation purchasing such
         assets shall assume by written instrument reasonably satisfactory in
         form and substance to the Holder executed and mailed or delivered to
         the registered Holder hereof at the last address of such Holder
         appearing on the books of the Company, the obligation to deliver to
         such Holder, upon Holder's exercise of this Warrant and payment of the
         purchase price in accordance with the terms hereof, such shares of
         stock, securities or assets as, in accordance with the foregoing
         provisions, such Holder may be entitled to purchase.

                                       4
<PAGE>

    2.4. Certain Events. If any change in the outstanding Common Stock of the
         Company or any other event occurs as to which the other provisions of
         this Section 2 are not strictly applicable or if strictly applicable
         would not fairly protect the purchase rights of the Holder of the
         Warrant in accordance with such provisions, then the Board of Directors
         of the Company shall make an adjustment in the number and class of
         shares available under the Warrant, the Exercise Price or the
         application of such provisions, so as to protect such purchase rights
         as aforesaid. The adjustment shall be such as will give the Holder of
         the Warrant upon exercise for the same aggregate Exercise Price the
         total number, class and kind of shares as he would have owned had the
         Warrant been exercised prior to the event and had he continued to hold
         such shares until after the event requiring adjustment.

    2.5. Notices of Change.

         2.5.1.   Upon any determination or adjustment in the number or class of
                  shares subject to this Warrant and of the Exercise Price, the
                  Company shall give written notice thereof to the Holder,
                  setting forth in reasonable detail and certifying the
                  calculation of such determination or adjustment.

         2.5.2.   The Company shall give written notice to the Holder at least
                  10 business days prior to the date on which the Company closes
                  its books or takes a record for determining rights to receive
                  any dividends or distributions.

         2.5.3.   The Company shall also give written notice to the Holder at
                  least 30 business days prior to the date on which an Organic
                  Change shall take place.

3.  ISSUE TAX. The issuance of certificates for shares of Common Stock upon the
    exercise of the Warrant shall be made without charge to the Holder of the
    Warrant for any issue tax (other than any applicable income taxes) in
    respect thereof; provided, however, that the Company shall not be required
    to pay any tax which may be payable in respect of any transfer involved in
    the issuance and delivery of any certificate in a name other than that of
    the then Holder of the Warrant being exercised.

4.  CLOSING OF BOOKS. The Company will at no time close its transfer books
    against the transfer of any warrant or of any shares of stock issued or
    issuable upon the exercise of any warrant in any manner which interferes
    with the timely exercise of this Warrant.

                                       5
<PAGE>

5.  NO VOTING OR DIVIDEND RIGHTS; LIMITATION OF LIABILITY. Nothing contained in
    this Warrant shall be construed as conferring upon the Holder hereof the
    right to vote as a shareholder of the Company. No dividends or interest
    shall be payable or accrued in respect of this Warrant, the interest
    represented hereby, or the shares purchasable hereunder until, and only to
    the extent that, this Warrant shall have been exercised. The Holder of this
    Warrant shall receive all notices as if a shareholder of the Company. No
    provisions hereof, in the absence of affirmative action by the Holder to
    purchase shares of Common Stock, and no mere enumeration herein of the
    rights or privileges of the Holder hereof, shall give rise to any liability
    of such Holder for the Exercise Price or as a shareholder of the Company,
    whether such liability is asserted by the Company or by its creditors.

6.  RIGHTS AND OBLIGATIONS SURVIVE EXERCISE OF WARRANT. The rights and
    obligations of the Company, of the Holder of this Warrant and of the holder
    of shares of Common Stock issued upon exercise of this Warrant, shall
    survive the exercise of this Warrant.

7.  FURTHER REPRESENTATIONS, WARRANTIES AND COVENANTS OF THE COMPANY.

    7.1  Articles and Bylaws. The Company has made available to Holder true,
         complete and correct copies of the Company Charter and Bylaws, as
         amended, through the date hereof.

    7.2  Due Authority. The execution and delivery by the Company of this
         Warrant and the performance of all obligations of the Company
         hereunder, including the issuance to Holder of the right to acquire the
         shares of Common Stock, have been duly authorized by all necessary
         corporate action on the part of the Company, and the Warrant is not
         inconsistent with the Company Charter or Bylaws and constitutes a
         legal, valid and binding agreement of the Company, enforceable in
         accordance with its terms.

    7.3. Consents and Approvals. No consent or approval of, giving of notice to,
         registration with, or taking of any other action in respect of any
         state, federal or other governmental authority or agency is required
         with respect to the execution, delivery and performance by the Company
         of its obligations under this Warrant, except for any filing required
         by applicable federal and state securities laws, which filing will be
         effective by the time required thereby.

    7.4. Issued Securities. All issued and outstanding shares of capital stock
         of the Company have been duly authorized and validly issued and are
         fully paid and nonassessable. All outstanding shares of capital stock
         were issued in full compliance with all federal and state securities
         laws.

                                       6
<PAGE>

    7.5. Exempt Transaction. Subject to the accuracy of the Holders
         representations in Section 8 hereof, the issuance of the Common Stock
         upon exercise of this Warrant will constitute a transaction exempt from
         (i) the registration requirements of Section 5 of the Securities Act of
         1933, as amended ("1933 Act"), in reliance upon Section 4(2) thereof,
         or upon the applicable exemption under Regulation D. and (ii) the
         qualification requirements of the applicable state securities laws.

    7.6. Compliance with Rule 144. At the written request of the Holder, who
         proposes to sell Common Stock issuable upon the exercise of the Warrant
         in compliance with Rule 144 promulgated by the Securities and Exchange
         Commission, the Company shall furnish to the Holder, within thirty (30)
         days after receipt of such request, a written statement confirming the
         Company's compliance with the filing requirements of the Securities and
         Exchange Commission as set forth in such Rule, as such Rule may be
         amended from time to time.

    7.7. Registration. If at any time the Company shall determine to register
         for its own account or the account of others under the Securities Act
         of 1933, as amended (including without limitation pursuant to the
         registration of any shareholder of the Company), any of its equity
         securities, other than on Form S-8 or Form S-4 or their then
         equivalents (a "Piggyback Registration"), it shall send the Holder
         written notice of such determination and, if within fifteen (15) days
         after receipt of such notice, Holder shall so request in writing, the
         Company shall use its diligent efforts to include in such registration
         statement all or any part of the shares of Common Stock or other
         securities issued or issuable upon conversion of this Note
         ("Registrable Shares") that Holder requests to be registered, except
         that if, in connection with any offering involving an underwriting of
         Common Stock to be issued by the Company the managing underwriter shall
         impose a limitation on the number of shares of Common Stock which may
         be included in the registration statement because, in its judgment,
         such limitations necessary to effect an orderly public distribution,
         then the Company shall be obligated to include in such registration
         statement only such limited portion (or none, if so required by the
         managing underwriter) of the Registrable Shares with respect to which
         such holder has requested inclusion hereunder. Except as specifically
         provided herein, all Registration Expenses incurred in connection with
         any registration under this Section shall be borne by the Company. All
         Selling Expenses incurred in connection with any registrations
         hereunder, shall be borne by the holders of the securities so
         registered pro rata on the basis of the number of shares so registered.
         For purposes of this Section, "Registration Expenses" means all
         expenses incurred by the Company in complying with this Section,
         including, without limitation, all registration and filing fees,
         printing expenses, fees and disbursements of counsel and independent
         public accountants for the company, fees and expenses of listing the
         securities with the securities exchange, fees and expenses (including
         counsel fees) incurred in connection with complying with state
         securities or "blue sky" laws, fees and expenses of one designated
         counsel for the Holder in connection with the registration of
         Registrable Shares, transfer taxes, fees of transfer agents and
         registrars, costs of any insurance which might be obtained, but
         excluding any Selling Expenses. For purposes of this Section, "Selling
         Expenses" means all underwriting discounts and selling commissions
         applicable to the sale of Registrable Shares and the fees and expenses
         of more than one counsel for the Holder in connection with the
         registration of Registrable Shares.

                                       7
<PAGE>

8.  REPRESENTATIONS AND COVENANTS OF THE HOLDER.

    8.1  This Warrant has been entered into by the Company in reliance upon the
         following representations and covenants of the Holder:

         8.1.1.   Investment Purpose. The Warrant or the Common Stock issuable
                  upon exercise of the Warrant will be acquired for investment
                  and not with a view to the sale or distribution of any part
                  thereof, and the Holder has no present intention of selling or
                  engaging in any public distribution of the same except
                  pursuant to a registration or exemption.

         8.1.2.   Private Issue. The Holder understands (i) that the Warrant and
                  the Common Stock issuable upon exercise of this Warrant are
                  not registered under the 1933 Act or qualified under
                  applicable state securities laws on the ground that the
                  issuance contemplated by this Warrant will be exempt from the
                  registration and qualifications requirements thereof, and (ii)
                  that the Company's reliance on such exemption is predicated on
                  the representations set forth in this Section 8.

         8.1.3.   Disposition of Holders Rights. In no event will the Holder
                  make a disposition of the Warrant or the Common Stock issuable
                  upon exercise of the Warrant unless and until (i) it shall
                  have notified the Company of the proposed disposition, and
                  (ii) if requested by the Company, it shall have furnished the
                  Company with an opinion of counsel (which counsel may either
                  be inside or outside counsel to the Holder) satisfactory to
                  the Company and its counsel to the effect that (A) appropriate
                  action necessary for compliance with the 1933 Act has been
                  taken, or (B) an exemption from the registration requirements
                  of the 1933 Act is available. Notwithstanding the foregoing,
                  the restrictions imposed upon the transferability of any of
                  its rights to acquire Common Stock issuable on the exercise of
                  such rights do not apply to transfers from the beneficial
                  owner of any of the aforementioned securities to its nominee
                  or from such nominee to its beneficial owner, and shall
                  terminate as to any particular share of stock when (1) such
                  security shall have been effectively registered under the 1933
                  Act and sold by the Holder thereof in accordance with such
                  registration or (2) such security shall have been sold without
                  registration in compliance with Rule 144 under the 1933 Act,
                  or (3) a letter shall have been issued to the Holder at its
                  request by the staff of the Securities and Exchange Commission
                  or a ruling shall have been issued to the Holder at its
                  request by such Commission stating that no action shall be
                  recommended by such staff or taken by such Commission, as the
                  case may be, if such security is transferred without
                  registration under the 1933 Act in accordance with the
                  conditions set forth in such letter or ruling and such letter
                  or ruling specifies that no subsequent restrictions on
                  transfer are required. Whenever the restrictions imposed
                  hereunder shall terminate, as hereinabove provided, the Holder
                  or holder of a share of stock then outstanding as to which
                  such restrictions have terminated shall be entitled to receive
                  from the Company, without expense to such Holder, one or more
                  new certificates for the Warrant or for such shares of stock
                  not bearing any restrictive legend.

                                       8
<PAGE>

         8.1.4.   Financial Risk. The Holder has such knowledge and experience
                  in financial and business matters as to be capable of
                  evaluating the merits and risks of its investment, and has the
                  ability to bear the economic risks of its investment.

         8.1.5.   Risk of No Registration. The Holder understands that if the
                  Company does not register with the Securities and Exchange
                  Commission pursuant to Section 12 of the 1933 Act, or file
                  reports pursuant to Section 15(d), of the Securities Exchange
                  Act of 1934 ("1934 Act"), or if a registration statement
                  covering the securities under the 1933 Act is not in effect
                  when it desires to sell (i) the Warrant, or (ii) the Common
                  Stock issuable upon exercise of the Warrant, it may be
                  required to hold such securities for an indefinite period. The
                  Holder also understands that any sale of the Warrant or the
                  Common Stock issuable upon exercise of the Warrant which might
                  be made by it in reliance upon Rule 144 under the 1933 Act may
                  be made only in accordance with the terms and conditions of
                  that Rule.

         8.1.6.   Accredited Investor. The Holder is an "accredited investor"
                  within the meaning of Regulation D promulgated under the 1933
                  Act.

9.  MODIFICATION AND WAIVER. This Warrant and any provision hereof may be
    changed, waived, discharged or terminated only by an instrument in writing
    signed by the party against which enforcement of the same is sought.

10. NOTICES. Any notice, request or other document required or permitted to be
    given or delivered to the Holder hereof or the Company shall be delivered or
    shall be sent by certified mail, postage prepaid, to each such Holder at its
    address as shown on the books of the Company or to the Company at the
    address indicated therefor in the first paragraph of this Warrant or such
    other address as either may from time to time provide to the other.

11. BINDING EFFECT ON SUCCESSORS. As provided in Section 2.3 above, this Warrant
    shall be binding upon any corporation succeeding the Company by merger,
    consolidation or acquisition of all or substantially all of the Company's
    assets. All of the obligations of the Company relating to the Common Stock
    issuable upon the exercise of this Warrant shall survive the exercise and
    termination of this Warrant. All of the covenants and agreements of the
    Company shall inure to the benefit of the successors and assigns of the
    Holder hereof.

                                       9
<PAGE>

12. DESCRIPTIVE HEADINGS AND GOVERNING LAW. The description headings of the
    several sections and paragraphs of this Warrant are inserted for convenience
    only and do not constitute a part of this Warrant. This Warrant shall be
    construed and enforced in accordance with, and the rights of the parties
    shall be governed by the laws of the State of Maryland.

13. LOST WARRANTS. The Company represents and warrants to the Holder hereof that
    upon receipt of evidence reasonably satisfactory to the Company of the loss,
    theft, destruction, or mutilation of this Warrant and, in the case of any
    such loss, theft or destruction, upon receipt of an indemnity reasonably
    satisfactory to the Company, or in the case of any such mutilation upon
    surrender and cancellation of such Warrant, the Company, at its expense,
    will make and deliver a new Warrant, of like tenor, in lieu of the lost,
    stolen, destroyed or mutilated Warrant.

14. FRACTIONAL SHARES. No fractional shares shall be issued upon exercise of
    this Warrant. The Company shall, in lieu of issuing any fractional share,
    pay the Holder entitled to such fraction a sum in cash equal to such
    fraction multiplied by the then effective Exercise Price.

IN WITNESS WHEREOF, the Company has caused this Warrant to be duly executed by
its officers, thereunto duly authorized this 4th day of November, 2002. .

                                   InforMedix Acquisition Corp.,
                                   a Delaware corporation

                                   By: /s/
                                       -----------------------------------------
                                   Name:
                                   Title:

ATTEST:

/s/
Secretary

                                       10
<PAGE>

                                   EXHIBIT A-1

                                SUBSCRIPTION FORM

Date:  _________________, _______

InforMedix Acquisition Corp. - Attn:  President

Ladies and Gentlemen:

         The undersigned hereby elects to exercise the warrant issued to it by
InforMedix Acquisition Corp. ("Company") and dated November 4, 2002, ("Warrant")
and to purchase thereunder __________________________________ shares of the
Common Stock of the Company ("Shares") at a purchase price of ________________
($______) per Share or an aggregate purchase price of __________________
________________ Dollars ($__________) ("Exercise Price").

         The undersigned hereby elects to convert _______________________
percent (____%) of the value of the Warrant pursuant to the provisions of
Section 1.2 of the Warrant.

         Pursuant to the terms of the Warrant, the undersigned has delivered the
Exercise Price herewith in full in cash or by certified check or wire transfer.

                                                  Very truly yours,

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00050-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00050-of-00352.parquet"}]]