<PAGE>
                                                                   EXHIBIT 10.46


                             DISTRIBUTION AGREEMENT


      This Distribution Agreement ("Agreement") is dated as of September 25,
2001 (the "Effective Date"), by and between Qualigen, Inc., a Delaware
corporation having its principal place of business at 2042 Corte del Nogal,
Carlsbad, CA 92009 ("Qualigen"), and Endocare, Inc., a Delaware corporation
having its principle place of business at 7 Studebaker, Irvine, CA 92618
("Endocare").

                                   BACKGROUND

      WHEREAS, Qualigen develops, manufactures, markets and sells the
FastPack(R) System, an immunoassay testing system for physician office
laboratory use, consisting of the FastPack Analyzer and FastPack disposable test
packs for performing a menu of immunoassay tests including, or planned to
include but not limited to, Total PSA, Free PSA and Testosterone (said analyzer
and disposable test packs hereinafter jointly referred to as the "Products");
and

      WHEREAS, Endocare desires to market and sell the Products in the United
States of America; and

      WHEREAS, Qualigen desires to grant Endocare, and Endocare desires to
obtain from Qualigen, non-exclusive distribution rights to market and sell the
Products to urology practices (the "Authorized Customers") in the United States
(hereinafter the "Territory") upon the terms and conditions set forth in this
Agreement.

      NOW, THEREFORE, in consideration of the mutual promises, covenants and
agreements set forth in this Agreement, Qualigen and Endocare agree as follows:

      Section 1. Appointment.

      1.1 Appointment of Endocare. Qualigen hereby appoints Endocare as a
non-exclusive distributor of the Products to Authorized Customers in the
Territory. Endocare may sell the Products either as an integral part of its
Diagnostic Workstation covered under a prior agreement, or as a stand-alone
product covered by this Agreement only to Authorized Customers in the Territory
(hereafter the "Market"). Nothing in this Agreement shall be construed to grant
any rights to Endocare to market or distribute the Products outside the
Territory or to any customers in the Territory that is not an Authorized
Customer.

      1.2 Parties Not Authorized to Act on Behalf of Each Other. Each party will
act on its own behalf in the performance of this Agreement and not as the agent
or legal representative of the other. This Agreement shall not be construed to
allow either party to create or assume any obligation on behalf of the other for
any purpose whatsoever. Endocare shall be solely responsible for and shall
indemnify and hold Qualigen free and harmless from any and all claims, damages
or lawsuits (including Qualigen's reasonable attorneys' fee) arising out of the
acts of Endocare, its employees or its agents.

      1.3 Endocare Affiliates and Subsidiaries. Endocare may perform its
obligations and exercise its rights under this Agreement itself or through an
affiliate or subsidiary of Endocare. Endocare shall impose on any affiliate or
subsidiary that sells or distributes Products hereunder the duty to comply with
the terms of this Agreement. The failure of any such affiliate, subsidiary or
other party to perform any such obligations hereunder shall be deemed a default
by Endocare under this Agreement on the same basis as Endocare's failure to so
perform would be a default. Invoices shall be issued to and product shall be
shipped to the entity specified in the applicable purchase order.

<PAGE>

      Section 2. Product Orders.

      2.1 Prices. Qualigen will sell Products to Endocare at the prices shown in
Exhibit "A."

                                       ***
                                      ***. Prices of the Products may be
changed from time to time by Qualigen through consultation between Qualigen and
Endocare, taking into account prevailing market conditions. Qualigen will
provide Endocare with sixty (60) days advance written notice of any price
changes. Such price changes shall apply only to orders received after the
effective date of the change. Price increases shall not affect unfulfilled
purchase orders accepted by Qualigen prior to the effective date of the price
increase.

      2.2 Order and Acceptance. All purchases of Product initiated by Endocare
shall be submitted by written purchase orders sent to Qualigen by mail or
facsimile and requesting a delivery date during the term of this Agreement. No
order shall be binding upon Qualigen until accepted by Qualigen in writing, and
Qualigen shall not have liability to Endocare with respect to purchase orders
that are not accepted in writing. Qualigen shall use its reasonable best efforts
to notify Endocare of the acceptance or rejection of an order and the assigned
delivery date for accepted orders within three (3) business days of receipt of
the purchase order. No partial shipment of an order shall constitute the
acceptance of the entire order, absent the written acceptance of such entire
order. Qualigen shall use its reasonable best efforts to deliver Products at the
times specified in its written acceptance of Endocare's purchase orders.

      2.3 Terms of Purchase Orders. Endocare's purchase orders submitted to
Qualigen shall be governed by the terms of this Agreement and nothing contained
in any such purchase orders shall modify the terms of purchase set forth on this
Agreement or add any additional terms or conditions. All purchase orders shall
be submitted by fax and paid for in accordance with the payment terms specified
in Section 3.2.

      Section 3. Shipment, Risk of Loss, Payment.

      3.1 Shipment, Title, Risk of Loss. All Products purchased by Endocare
shall be delivered to Endocare or a party designated by Endocare *** Qualigen's
plant, Carlsbad, California. ***
                                      ***
                                      ***.

      3.2 Payment. Endocare will make payment by check or wire transfer within
thirty (30) days from date of each invoice. Interest will be payable on payments
not received within thirty (30) days from the date of each invoice, at the rate
of *** per month on the unpaid balance or the maximum allowed under law,
beginning thirty (30) days from the date of invoice.

      Section 4. Representations and Obligations of Qualigen.

      4.1 Contractual Authority. Qualigen represents that it has full right,
title and unencumbered proprietary interest in and to the Products and full
authority to consummate the transactions contemplated herein. The granting by
Qualigen to Endocare of the non-exclusive right to sell the Products does not
require the consent, waiver, approval, or authorization of any person or
authority and does not violate any other agreements, instruments, or rights of
any third party.


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      4.2 Promotional Materials. Qualigen shall provide, in reasonable
quantities, sales and promotional material for the Products at Endocare's
expense.

      4.3 Non-Discriminatory Pricing. Qualigen will extend to Endocare pricing
terms equal to the lowest prices being offered by Qualigen to other distributors
of the Products to Authorized Customers in the Territory.

      4.4 Technical Service and Support. Qualigen will provide efficient
technical service and customer support to all customers of Endocare both during
and following any applicable warranty period. In the event that Qualigen is
unable to provide technical or customer support to the customers following the
warranty period, Qualigen will provide Endocare with all training and other
information and resources necessary to provide efficient technical service and
customer support on the Products.

      Section 5. Representations and Obligations of Endocare.

      5.1 Product Promotion. Endocare represents that it has experience in
marketing and selling related products to Authorized Customers in the Territory,
it has the financial resources to market the Products and it shall use
reasonable efforts to actively promote, market and sell the Products to
Authorized Customers in the Territory and seek to achieve the maximum
utilization potential in the Territory.

      5.2 Sales Forecasts. Endocare shall provide Qualigen with annual forecasts
of projected purchases of Products broken out on a quarterly basis and shall
update such forecasts throughout the year as reasonably requested by Qualigen
and as anticipated variances exceed more than *** of quarterly forecasted
amounts. Such forecasts shall be for planning purposes only and shall not
constitute binding purchase commitments.

      5.3 Sales Reports.Endocare shall deliver reports of sales, pricing, and
other information reasonably requested by Qualigen pertaining to the
distribution and marketing of the Products in the Territory.

      5.4 Regulatory Compliance. Endocare will cooperate fully with Qualigen to
provide and implement Product tracing and incident notification procedures
necessary to comply with FDA medical device reporting requirements and other
applicable federal and state legal requirements.

      5.5 Limitations of Authority. Endocare shall not solicit or receive
purchase orders from customers who are not Authorized Customers located in the
Territory.

      5.6 Competing Products. Endocare shall not directly or indirectly sell,
lease or otherwise distribute any product that, in Qualigen's reasonable
judgment, competes with the Products, without Qualigen's prior written consent.

      5.7 General Conduct. Endocare shall conduct its business so as to reflect
favorably on Qualigen and the Products.


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      Section 6. Shared Obligations of Qualigen and Endocare.

      6.1 Compliance with Laws and Regulations. Endocare and Qualigen shall
comply with all applicable laws, statutes, and regulations relating to
production, marketing, sales, and distribution of the Products in the Territory.

      6.2 Customer Requirements. Endocare shall assist Qualigen in assessing
customer requirements for the Products, including modifications and improvements
thereto, in terms of quality, design, functional capability and other features.

      6.3 Expenses and Personnel. Endocare and Qualigen shall be solely
responsible for their respective expenses and those of their staff and agents.

      Section 7. Warranty to Endocare's Customers

      7.1 Standard Limited Warranty. Endocare shall pass on to its customers
Qualigen's standard limited warranty for the Products set forth in Exhibit "B"
hereto, including the limitations set forth therein. The length of the "Warranty
Period," as defined in the standard Product Warranty, shall be:

      Analyzer and
      Accessories  - One year on all components.

      Reagent Packs - The lesser of one year or the expiration date
                      set forth on the label. Expiry dated products shall
                      have a minimum shelf life of twelve (12) weeks prior
                      to expiry date from the date of shipment.

      On Products manufactured by third parties and distributed by Qualigen, the
manufacturers warranty will be passed on to Endocare's initial purchaser.

      7.2 Warranty Service. Endocare agrees to act as a liaison between Qualigen
and Endocare's customers regarding warranted Products and, where appropriate, to
perform initial inspection of such Products prior to returning them to Qualigen
for warranty service.

      Section 8. Property Rights and Confidentiality

      8.1 Property Rights. Endocare agrees that Qualigen owns all right, title
and interest in the Product lines that include the Products now or hereafter
subject to this Agreement and in all of Qualigen's patents, trademarks, trade
names, inventions, copyrights, know-how and trade secrets relating to the
design, manufacture, operations or service of the Products. The use by Endocare
of any of these property rights is authorized only for the purposes herein set
forth and, upon termination of this Agreement for any reason, such authorization
shall cease. The Products are offered for sale and are sold by Qualigen subject
in every case to the condition that such sale does not convey any license,
expressly or by implication, to manufacture, duplicate, re-label or otherwise
copy or reproduce any of the Products.

        8.2 Confidentiality. Endocare acknowledges that by reason of its
relationship to Qualigen hereunder it will have access to certain information
and materials concerning Qualigen's business plans, customers, technology and
Products that are confidential and of substantial value to Qualigen, which value
would be impaired if such information were disclosed to third parties. Endocare
agrees that it will not use in any way for its own account or the account of any
third party, nor disclose to any third party, any such confidential information
revealed to it by Qualigen. Endocare shall take every reasonable


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precaution to protect the confidentiality of such information. In the event of
termination of this Agreement, there shall be no use or disclosure by Endocare
of any confidential information of Qualigen, and Endocare shall not manufacture
or have manufactured any devices, components or assemblies utilizing any of
Qualigen's confidential information.

      Section 9. Trademarks and Trade Names.

      9.1 Use. During the term of this Agreement, Endocare shall have the right
to indicate to the public that it is an authorized distributor of Qualigen's
Products and to advertise (within the Territory) such Products under the
trademarks, marks and trade names that Qualigen may adopt from time to time
("Qualigen's Trademarks"). Endocare shall not alter or remove any Qualigen's
Trademark applied to the Products at the factory. At no time during or after the
term of this Agreement shall Endocare challenge or assist others to challenge
Qualigen's Trademarks or the registration thereof or attempt to register any
trademarks, marks or trade names confusingly similar to those of Qualigen.

      9.2 Approval of Representation. All representations of Qualigen's
Trademarks that Endocare intends to use shall first be submitted to Qualigen for
approval of design, color and other details or shall be exact copies of those
used by Qualigen. The use of any other mark on a Product in conjunction with the
Qualigen Trademarks also shall be submitted to Qualigen for approval under the
preceding sentence.

      Section 10. Patent, Copyright and Trademark Indemnity

      10.1 Indemnification. Qualigen shall, at its own expense, defend or settle
any claim, suit or proceeding brought against Endocare or its customer for
infringement of any United States or foreign patents or trademark by Products
sold hereunder, or the use thereof, subject to the limitations hereinafter set
forth. Qualigen shall have the sole control of any such action or settlement
negotiations and Qualigen agrees to pay, subject to the limitations hereinafter
set forth, any final judgment entered against Endocare or its customer on such
issue in any such suit or proceeding defended by Qualigen. Endocare agrees that
Qualigen shall be relieved of the foregoing obligations unless Endocare or its
customer notifies Qualigen promptly in writing of such claim, suit or proceeding
and gives Qualigen authority to proceed as contemplated herein.

      10.2 Limitation. Qualigen shall not be obligated to indemnify Endocare
under Section 10.1, above, if a claim for patent or trademark infringement is
the result of a modification of any Product which was not performed by Qualigen,
the use of a Product in combination with any other product or assembly not
supplied by Qualigen, or any markings or branding of a Product not applied by
Qualigen.

      10.3 Entire Liability. The foregoing provisions of this Section 10 state
the entire liability and obligations of Qualigen and the exclusive remedy of
Endocare and its customers with respect to any alleged patent or trademark
infringement by the Products or any part thereof.

      Section 11. Term and Termination.

      11.1 Term. The term of this Agreement shall commence on the date hereof
and continue for five (5) years. After the expiration of the initial five-year
term, this Agreement shall automatically renew for successive terms of one year
each until terminated by either party, with or without cause, on ninety (90)
days written notice.

      11.2 Termination for Cause. Either party may terminate this Agreement for
cause upon the breach by the other party of any material term or condition
hereof. Upon a material breach, the non-breaching party shall give the breaching


                                      -5-
<PAGE>

party thirty (30) days written notice of the breach. The breaching party shall
have thirty (30) days from the sending of the notice in which to cure its breach
and avoid termination.

      11.3 Termination Without Cause. Either party may termination this
Agreement without cause upon ninety (90) days' written notice to the other
party.

      11.4 Customer Supply Following Termination. In the event that Qualigen
elects to terminate this Agreement pursuant to Section 10.3 ("Termination
Without Cause"), hereof, Qualigen shall continue to sell FastPack test packs to
Endocare for a period of one (1) year thereafter in sufficient quantity to meet
the ongoing demands of customers to whom Endocare has sold FastPack Systems.
Following the end of such one-year period, Qualigen agrees to sell FastPack test
packs directly to such customers for as long as demand exists.

      Section 12. Indemnification, Disclaimer of Warranty, Limitation of
Liability.

      12.1 Endocare's Indemnification of Qualigen. Endocare shall, at Endocare's
sole cost and expense, indemnify, defend and hold Qualigen, its licensors and
service providers, and their respective officers, directors, employees, agents
and consultants harmless from and against any judgment or settlement and
associated litigation and/or settlement costs (including reasonable attorney's
fees and costs) that arise out of the negligent or intentionally tortious
conduct of Endocare's business, or Endocare's use or sale of Products delivered
to it by Qualigen. Qualigen shall provide Endocare with written notification of
any claim subject to indemnification pursuant to this Section 12 and of any
associated court filings promptly after Qualigen first learns of them. Qualigen
shall provide Endocare with such assistance and cooperation as Endocare may
reasonably request from time to time in connection with the defense thereof.
Qualigen will use reasonable efforts to mitigate all such claims, losses,
damages, expense or liability after receipt of notice thereof.

      12.2 Qualigen's Indemnification of Endocare. Qualigen shall, at Qualigen's
sole cost and expense, indemnify, defend and hold Endocare, its licensors and
service providers, and their respective officers, directors, employees, agents
and consultants harmless from and against any judgment or settlement and
associated litigation and/or settlement costs (including reasonable attorney's
fees and costs) that arise out the Products' failure to meet the applicable
Warranty and for any claims based on products liability theory against the
Products. Endocare shall provide Qualigen with written notification of any claim
subject to indemnification pursuant to this Section 12 and of any associated
court filings promptly after the Endocare first learns of them. Endocare shall
provide Qualigen with such assistance and cooperation as Qualigen may reasonably
request from time to time in connection with the defense thereof. Endocare will
use reasonable efforts to mitigate all such claims, losses, damages, expense or
liability after receipt of notice thereof.

      12.3 Cross Indemnification. Each party shall indemnify the other against
any and all loss, liability, cost or expense, including reasonable attorneys'
fees, in any way arising out of any breach of warranty or representation
hereunder, or any recklessness or willful misconduct in connection with the
implementation and carrying out of the terms of this Agreement.

      Section 13. Notices.

      13.1 Notices. Any notice, request, demand, or other communication required
or permitted hereunder shall be deemed to be properly given when received by fax
or received by mail, postage prepaid, addressed:

                                      -6-
<PAGE>


            To Endocare:

                    Endocare, Inc.
                    7 Studebaker
                    Irvine, CA  92618
                    U.S.A.
                    Attention:  ***

            To Qualigen:

                    Qualigen, Inc.
                    2042 Corte del Nogal
                    Carlsbad, CA  92009
                    Attention:  ***


      Section 14. General Provisions

      14.1 Governing Law. This Agreement will be interpreted and construed in
accordance with the laws of the State of California, excluding any choice of law
provisions, and without regard to which party drafted particular provisions of
the Agreement.

      14.2 Arbitration. Any claim, dispute or controversy under this Agreement,
including the interpretation of any of the provisions hereof, shall be settled
exclusively by arbitration in Los Angeles, California, and shall be conducted in
accordance with the then current Commercial Arbitration Rules of the American
Arbitration Association ("AAA"). The arbitrator shall be selected jointly by the
parties, but if the parties cannot agree upon an arbitrator within thirty (30)
days after a parties notifies the other party of its intention to arbitrate, the
arbitrator shall be appointed by the AAA. The arbitrator shall render a written
opinion stating the reasons for his decision within three (3) months after the
request for arbitration. The decision of the arbitrator shall be final and
binding upon the parties and shall not be subject to any rights of appeal.
Judgment upon an award may be entered in any competent court. Each party shall
be responsible for the fees and expenses of its legal counsel and the parties
shall share equally in the costs and charges of the AAA and of the arbitrator.

      14.3 Assignment. Neither Qualigen nor Endocare shall assign its rights or
obligations under this Agreement without the prior written consent of the other
party hereto; provided, however, that Qualigen may, without Endocare's consent,
assign this Agreement and its rights and obligations hereunder in connection
with the transfer or sale of all or substantially all of Qualigen's assets or
equity, or in the event of its merger or consolidation or change in control or
similar transaction.

      14.4. Entire Agreement. This Agreement sets forth the entire agreement and
understanding of the parties relating to the subject matter of this Agreement
and merges all prior discussions between them. No modification of or amendment
to this Agreement, or any waiver of any rights under this Agreement, shall be
effective unless in writing signed by the party to be charged.

      14.5. Headings. The descriptive headings of this Agreement have been
inserted for convenience and shall not be deemed to limit or otherwise affect
the construction of any provision hereof.

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<PAGE>

      14.6 Severability. If any provision of this Agreement is held to be
invalid by a court of competent jurisdiction, then the remaining provisions
shall nevertheless remain in full force and effect. The parties agree to
re-negotiate in good faith any term held invalid and to be bound by the mutually
agreed substitute provision.

      14.7 Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original and all of which
together shall constitute but one and the same instrument.

      IN WITNESS WHEREOF, the parties hereby execute this Agreement as of the
date set forth above.


ENDOCARE, INC.                          QUALIGEN, INC.
a Delaware Corporation                  a Delaware Corporation



By: /s/ Paul Mikus                      By: /s/ Michael S. Poirier
    -------------------------------         ---------------------------------
    Paul Mikus                              Michael S. Poirier
    Chairman & CEO                          Chairman & CEO

                                      -8-
<PAGE>

                                   EXHIBIT "A"

                                   PRICE LIST


<TABLE>
<CAPTION>
Part Number       Product Description                                     Endocare Price
-----------       -------------------                                     --------------
<S>               <C>                                                     <C>
                  SYSTEMS
20000001          FASTPACK(TM) SYSTEM                                            ***

                      Contents:  FastPack Analyzer
                                 FastPack Power/Air Supply
                                 FastPack Sample Dispenser
                                 Multilingual Procedure Manual
                                 FastPack Training Video
                                 Ink Cartridge Kit

                  FASTPACK CASSETTES

                        ***:

25000001          FastPack Total PSA Kit-50                                      ***

25000006          FastPack Free PSA Kit-50                                       ***

25000007          FastPack Testosterone Kit-50                                   ***

                        ***:

25000001          FastPack Total PSA Kit-50                                      ***

25000006          FastPack Free PSA Kit-50                                       ***

25000007          FastPack Testosterone Kit-50                                   ***

                  CALIBRATION PRODUCTS
25000002          FastPack Calibrator Kit                                        ***

250000003         FastPack Controls Kit                                          ***

                  OTHER PRODUCTS
20000009          FastPack Stacking Bracket                                      ***

20000010          Tricontinent(TM) Plastic Pipette                               ***

17000034          Eppendorf(TM) Pipette Tips Pack (qty: 96)                      ***

17000015          US Power Cord (already included in FastPack System)            ***
</TABLE>


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<TABLE>
<S>               <C>                                                            <C>
20000011          Ink Cartridge Kit                                              ***

65000001          Procedure Manual--Multilingual                                 ***

68000004          CLIA Compliance Manual                                         ***
</TABLE>


          (C) 2001 Qualigen, Inc. All rights reserved. Qualigen and FastPack are
trademarks or registered trademarks of Qualigen, Inc. All other trademarks are
the property of their respective owners.



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                                   EXHIBIT "B"

                   LIMITED WARRANTY TO DISTRIBUTOR'S CUSTOMERS


The "Warranty Period" for each Product is set forth in the Distribution
Agreement. Qualigen will provide the following limited warranty for the Products
to the initial purchaser ("Customer") from Distributor. Qualigen warrants that
throughout the applicable Warranty Period the Products will be free from defects
in materials and workmanship and will perform as set forth in Qualigen'
published product specification and operator manual in effect at the time of
delivery.

Qualigen's liability for all matters arising under this warranty shall be
limited solely to the repair or (in Qualigen's sole discretion) replacement of
the Product. If Qualigen reasonably determines that a repair or replacement is
covered by this warranty, Qualigen shall bear the cost of shipping the repaired
or replacement Product to the Customer. All other shipping costs shall be paid
by the Customer. Risk of loss or damage during shipments under this warranty
shall be the responsibility of the party shipping the Product. If Product
shipped to Qualigen under this warranty is not suitably packaged for shipment,
any physical damage present in the Product on receipt by Qualigen (and not
previously reported) shall be presumed to have occurred in transit and will be
the responsibility of the Customer.

Qualigen shall not be obligated under this warranty if the need for repairs or
replacements directly or indirectly results from Customer's: (i) failure to use
or store the Product as specified by Qualigen; (ii) failure to properly perform
the services or maintenance required in the Operator's Manual for a Product;
(iii) repairs to a Product by persons other than Qualigen service personnel;
(iv) replacement of parts with other than Qualigen genuine parts; (v) negligence
or negligent operation of any Product; or (vi) alterations or modifications of
any Product without authorization from Qualigen.

THIS WARRANTY, TOGETHER WITH ANY OTHER WRITTEN WARRANTY THAT MAY BE ISSUED BY
QUALIGEN, IS THE SOLE AND EXCLUSIVE WARRANTY AS TO QUALIGEN' PRODUCTS, EXTENDS
ONLY TO THE CUSTOMER AND IS EXPRESSLY IN LIEU OF ANY ORAL OR IMPLIED WARRANTIES
INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE OR WARRANTY AGAINST INFRINGEMENT.

                             LIMITATION OF LIABILITY

EXCEPT AS PROVIDED IN THE PRODUCT LIABILITY INDEMNIFICATION AGREEMENT OF THE
DISTRIBUTION AGREEMENT, IN NO EVENT SHALL QUALIGEN BE LIABLE TO DISTRIBUTOR OR
ITS CUSTOMERS OR ANY OTHER PERSON FOR INCIDENTAL, SPECIAL OR CONSEQUENTIAL
DAMAGES OR LOST PROFITS, EVEN IF QUALIGEN HAS BEEN ADVISED OF THE POSSIBILITY
THEREFOR, ARISING OUT OF OR IN CONNECTION WITH THE SALE, DELIVERY, INSTALLATION,
USE, LOSS OF USE, REPAIR OR PERFORMANCE OF THE PRODUCTS, INCLUDING ALL ADDITIONS
TO AND REPLACEMENTS OF THE PRODUCTS OR ANY FAILURE OR DELAY IN CONNECTION WITH
ANY OF THE FOREGOING.


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