EXHIBIT 10.33
DEPARTMENT OF VETERANS AFFAIRS
NATIONAL ACQUISITION CENTER
PO BOX 76, BLDG. 37, 90N-M3
HINES, IL 60141
March 8, 2002
Xxxx Medical Technologies, Inc.
DBA: Osbun Medical
Attn: Xxxxxx X. Xxxxxx
0000 Xxxx Xxxx Xxxxxxx
Xxxx Xxxxxxx, XX 00000
Dear Xx. Xxxxxx:
Enclosed is your copy of Blanket Purchase Agreement (BPA) VANAC-90NCPR-02-0001
for Vacuum Erection Devices. The BPA's effective dates are April 1, 2002 to
March 31, 2005.
We are pleased to hear that Xxxx will be sending a representative to our VISN
Prosthetic Representatives Meeting in Las Vegas. I will call Xxxxxxx Xxxxxxx as
soon as I receive the final times and dates of the meeting.
If you have any questions or concerns, please call me at (000) 000-0000 or
e-mail xxxxxxxx.xxxxxx@xxx.xx.xxx.
Sincerely,
/s/ XXXXXXXX XXXXXX
Xxxxxxxx Xxxxxx
Contracting Officer
National Contracts Service
DEPARTMENT OF VETERANS AFFAIRS
VACUUM ERECTION DEVICES
BLANKET PURCHASE AGREEMENT
REQUEST FOR QUOTATION
RFQ NO. NCPR000001 BPA NO. VANAC-90NCPR-02-001
CONTRACT NO. V797P-3456K DUE DATE: November 26, 2001
This is a request for a Blanket Purchase Agreement (BPA) quotation pursuant to
Clause I-FSS-646-A of your Federal Supply Schedule (FSS) contract. The
Department of Veterans Affairs (VA) Prosthetics and Sensory Aids Service (PSAS)
intends to establish a national mandatory source for Vacuum Erection Devices
(VED) for PSAS and to secure the lowest price possible for these products. PSAS
intends to standardize on VEDs that will be evaluated and determined to meet
PSAS's needs. Upon reaching mutual agreement on price and terms, this document
will be executed by both parties thereby making the BPA effective.
1. SCOPE
The following provides an overview of the terms and conditions of this BPA
request:
a) In exchange for becoming a mandatory source, VA requests additional
price considerations for VEDs.
b) All sales under this agreement will be attributable to the BPA
Contractor's current FSS contract and subject to the Industrial
Funding Fee (IFF).
c) A BPA will be established with the offeror whose quote offers the
best overall value to VA, considering product conformity to
specifications, availability of patient education and post treatment
follow up, price, and past performance.
d) This BPA, including product prices and other terms and conditions,
is public information and is releasable under the Freedom of
Information Act (FOIA). Procurement related information, including
negotiations, shall be treated as confidential and shall not be
disclosed except as required by applicable laws and regulations.
e) Specifications:
1. Single-handed operation
2. Manually controlled
3. Must have pressure release valve
4. Includes several sizes of bands
f) Evaluation Factors: See Attachment A
2. PERIOD OF AGREEMENT
This BPA is effective 45 days after (or earlier by mutual consent) the
date signed by the Government and expires two years thereafter or at the
end of the FSS contract period (including extensions, if any), whichever
is earlier. If a new FSS contract is awarded to Contractor before this BPA
expires, the parties by mutual agreement may establish a follow-on BPA
against the new FSS contract for the remaining term of this BPA. The
follow-on BPA shall cover the products covered by this BPA and shall
contain terms and conditions substantially the same as the terms and
conditions of this BPA. The maximum term of this BPA and follow-on BPA, if
any, shall be two years from the effective date of this BPA. A Government
review of the estimated purchases and the corresponding discounts for this
BPA will be performed annually. If a follow-on BPA is contemplated, a
review of the estimated purchases and the corresponding discounts will be
performed before the follow-on BPA is established and annually thereafter.
3. PRODUCT EVALUATION
PSAS and the National Acquisition Center will evaluate sample VEDs which
are offered in response to this offer. See Attachment A.
4. UNINTERRUPTED SOURCE OF SUPPLY
By signing this BPA, the offeror guarantees to provide an uninterrupted
source of supply of the originally awarded item(s) to satisfy PSAS's
requirement for the performance period of the awarded BPA. If, however,
the contractor determines to terminate production of the awarded item(s)
and contemplates replacement with alternative item(s), VA reserves the
right to evaluate the potential replacement item(s). There is no guarantee
that VA will evaluate any replacement item(s) favorably. If VA determines
the replacement item(s) is unacceptable, the individual item(s) or the
entire BPA may be cancelled.
5. ESTIMATED VOLUME
PSAS's Data Validation Group (DVG) indicates the estimated annual volume
of purchases is approximately 16,000 units.
6. AGGREGATE PURCHASES LESS THAN ESTIMATED VOLUME OF PURCHASES.
If the Government does not achieve the estimated volume of purchases, the
Contractor hereby waives any right to collect the difference in price
between the actual level achieved and the anticipated level.
7. AWARD ON INITIAL OFFERS
The Government intends to evaluate proposals and award a BPA without
discussions with offerors (except communications conducted for the purpose
of minor clarifications). Therefore, each initial offer should contain the
offeror's best price. However, the Government reserves the right to
conduct discussions at the contracting officer's discretion.
8. EXTENT OF OBLIGATION
The Government is obligated only to the extent of authorized purchases
made under this BPA. This BPA does not obligate any funds.
9. SALES REPORTS
The contractor's quarterly reports of sales will also include these
purchases and reflect the appropriate discount given.
10. NOTICE OF INDIVIDUALS AUTHORIZED TO PURCHASE UNDER THE BPA
Any individual who has authorized ordering/contracting authority, on
behalf of VA's PSAS to place delivery (purchase) orders may use this BPA.
11. ORDERING METHOD
Orders will be placed against this BPA via Electronic Data Interchange
(EDI), if the contractor has this capability; facsimile; in writing; or by
phone.
12. DELIVERY TICKETS
Unless otherwise agreed to, all deliveries under this BPA must be
accompanied by delivery tickets or sales slips that must contain the
following information as a minimum:
a) Name of contractor
b) Contract Number
c) BPA Number
d) Model Number or National Stock Number (NSN)
e) Purchase Order Number
f) Date of Purchase
g) Quantity, unit price, and extension of each item (unit prices
and extensions need not be shown when incompatible with the
use of automated systems, provided that the invoice is
itemized to show the information); and
h) Date of shipment
13. INVOICES
An itemized invoice shall be submitted to the VA billing address listed on
each deliver (purchase) order. The requirement of a proper invoice are as
specified in the FSS contract. The itemized invoice shall identify the
delivery ticket or packing list, ship-to-address of supplies, the BPA
number, and the delivery (purchase) order number assigned by the
individual facility at the time of ordering.
14. REPORTS
The contractor shall provide a quarterly report of sales broken out for
each medical center within 30 days after the close of each quarter's
business. Reports should reflect total sales by line item number for each
medical center. Reports shall be sent to the following address:
Department of Veterans Affairs
National Acquisition Center
National Contracts Division (90N-C-PR)
P.O. Box 76, Hines, IL 60141-0076
15. BPA MODIFICATIONS
This BPA may be modified by mutual agreement of the Government and
Contractor. Each such modification shall be in writing, issued by the VA
National Acquisition Center, and signed by the Government and the
Contractor. Modifications shall become effective on the date signed by the
Government.
16. CANCELLATION
Each party may terminate this agreement at any time by giving to the other
written notification of its intent to do so, not less than 30 days prior
to the effective date of the termination.
17. ORDER OF PRECEDENCE
All FSS contract terms and conditions apply to this BPA unless modified by
the BPA. The terms and conditions of this BPA apply to all purchases made
pursuant to it. In the event of an inconsistency between the provision of
this BPA and the Contractor's invoice, the provisions of this BPA will
take precedence.
18. DEADLINES FOR QUOTES
Contractor quotations are to be delivered no later than 4.00 p.m. (CST) on
November 26, 2001. Quotes submitted after this time will not be
considered. Quotes may be faxed or mailed to the address listed below. If
faxed, an original document with signatures must be submitted to the a
timely manner.
Xxxx Medical Technologies, Inc.
/s/ XXXXXX X. XXXXXX 21 Nov 01
----------------------------------------- ---------------------------------
Xxxxxx X. Xxxxxx Date Signed
Authorized Negotiator
/s/ (Illegible) 2/26/02
----------------------------------------- ---------------------------------
Government Contracting Officer Date Signed
VA National Acquisition Center
ATTN: Xxxxxxxx Xxxxxx
National Contracts Service
1st Avenue, One Block North of Xxxxxx
Building 00
Xxxxx, XX 00000
Telephone: (000) 000-0000
Fax: (000) 000-0000
ADDITIONAL INFORMATION REQUESTED
Company Name: Xxxx Medical Technologies, Inc.
DBA: Xxxxx Medical
0000 Xxxx Xxxx Xxxxxxx
Xxxx Xxxxxxx, XX 00000
Phone: (000) 000-0000, (000) 000-0000, (000) 000-0000
Facsimile: (000) 000-0000
Contractor Number: V797P-3456K
Expiration Date of FSS Contract: January 31, 2004
Business Size: Small (less than 100 employees)
Payment Terms: 2%-30 ARO [No Change from FSS]
Delivery: Within 30 days [No Change from FSS]
Emergency Delivery: Within 5 days ARO [No Change from FSS]
Minimum Order: $100 [No Change from FSS]
Are any of the items offered under this BPA foreign? NO
Does your company currently accept the Government Credit Card? YES
Is your company EDI capable? YES
ATTACHMENT A
(a) Vacuum Erection Device Quotation
Product: Xxxxx Erecaid(R)
Esteem(TM) Manual System
Model Number: 1130
Offered price: $79.95
Specifications:
Stated:
1. Single-handed operation
2. Manually controlled
3. Pressure release valve`
4. Four different sizes and tensions of bands
Additional Specifications:
1. Easy-action tension band (ring) loader
2. Tube of Xxxxx personal lubricant
3. Travel case
4. Patient instructional video and user guide
Additional Warranties:
l. During the term of this BPA, Xxxx Medical will maintain a medically certified
domestic field organization of no less than 30 certified Clinical Technicians,
to perform clinical applications/demonstrations to any and all VA patients
purchasing, or having already purchased, an Xxxxx XXX.
2. To ensure that product warranty obligations will be met for the life of any
Xxxxx XXX purchased by the VA, Xxxx Medical will maintain a working capital
level of no less than $2 million for the duration of this BPA.
3. During the term of this BPA, Xxxx Medical will maintain $5,000,000 of
comprehensive liability coverage on all VED products and related services.
(c) Patient Education and Post Treatment Follow-up
Included in the Offered Price are the following services:
1. PATIENT TRAINING
The American Urological Association recommends any men interested in
trying vacuum therapy to be given individual instruction in its use.
Patients who rely on the manufacturer's printed or videotaped
instructions are less likely to master the use of the vacuum device
than those given a demonstration by a physician or experienced
technician.
Erectile Dysfunction Guidelines Developed for Primary Care by the
Department of Veteran Affairs (May, 2000) states "The successful
utilization of a vacuum tumescence device depends on appropriate
patient education and counseling . . . Compliance and acceptance of
the therapy have been shown to be dependent on individualized
instruction . . . by a fully trained, qualified instructor . . .
Qualified instructors may include urologists, physician extenders,
nurse specialists, or certified manufacturer representatives."
Because the quality of the patient training is only as good as the quality of
the training of the individuals delivering that patient training, Xxxx Medical
has established a training standard that is second to none. The Xxxxx Vacuum
products are solicited and detailed by professionally trained Clinical
Technicians who complete a certification process accredited by the Certification
Board of Urologic Nurses and Associates. No other vacuum device company offers
this accreditation nor meets the requirements for accreditation. This
certification process includes annual product and medical-condition education.
Participants in the training are required to demonstrate their knowledge before
being permitted to participate in patient consultations. Copies of the stringent
qualifications for clinical certification and our current CBUNA certificate are
attached (Addendum A-l).
Xxxx'x unique training program ensures that VA patients will receive proper
instruction in the use and maintenance of their Xxxxx vacuum device, optimizing
patient satisfaction. Xxxx Medical will guarantee that a certified clinical
technician will be available to each VA patient prior to, and following, the
dispensing an Xxxxx ErecAid Esteem Manual System.
2. 24 HOUR PATIENT SUPPORT
Xxxx Medical provides toll-free, 24-hour, 7 day-a-week patient support services,
available to all registered Xxxxx ErecAid owners, staffed by Certified Xxxxx
Technical Advisors. These personnel are supervised by Board Certified Urologists
who are available to augment and lend expertise to any impotence training
provided by VA healthcare professionals.
3. PATIENT FOLLOW-UP
Xxxx Medical's certified Technical Advisor's conduct post-purchase customer
follow-up (via phone and mailer) to ensure that all patient questions and
concerns have been addressed. Any VA patient receiving an Xxxxx ErecAid System
may request additional product demonstrations, performed by their certified
Clinical Technician.
Through computer registration and voluntary responses to questionnaires, Xxxx
Medical has gathered the most comprehensive patient information database
available. This data was first published in medical literature in 1989. With
hundreds of thousands of ErecAid Systems prescribed, this database represents
the largest single source of significant medical information validating the use
of vacuum therapy in the medical management of erectile dysfunction. The Xxxxx
ErecAid System claims a substantial body of clinical studies from hospitals and
universities in many countries which support an effectiveness rating of over 90%
for erectile dysfunction of almost any etiology. THE XXXXX ERECAID SYSTEM IS THE
ONLY EXTERNAL VACUUM DEVICE TO HAVE OVER 20 PUBLISHED STUDIES DOCUMENTING
SAFETY, EFFECTIVENESS AND PATIENT ACCEPTANCE.
4. PROFESSIONAL EDUCATIONAL MATERIAL
Xxxx Medical provides, free-of-charge, comprehensive educational materials on
the causes and treatments of erectile dysfunction to VA healthcare
professionals. This information is available in both booklet and video form.
A sample of this information (i.e. the Couple's Guide for the treatment of
Erectile Dysfunction) is enclosed (Addendum A-4).
5. REGULATORY COMPLIANCE (MANUFACTURING STANDARDS)
Xxxx Medical's facilities are well equipped and registered to produce FDA Class
I, II and III medical devices, with full ISO 9001, EN 46001 and CE mark
certifications. Xxxx Medical is routinely inspected by the FDA, and has always
maintained a "good standing" rating.
6. 90 DAY REFUND POLICY
All Xxxxx vacuum devices carry an unmatched 90-day refund policy. The policy
provides for a 100% refund if the patient is not completely satisfied. In the
VA's case, Xxxx Medical will refund the VA by either replacing a returned system
with a new System or, at the discretion of the VA, by issuing a credit.
7. LIFETIME WARRANTY
Xxxx Medical provides a lifetime warranty on the major components of each Xxxxx
ErecAid System. All registered owners may return the components directly to Xxxx
Medical for free replacement.
8. LIABILITY INSURANCE
Xxxx Medical maintains $5,000,000 of comprehensive liability coverage on all
products and services. In addition to the stringent professional training,
product quality, and regulatory compliance specifications delineated above, Xxxx
Medical's Product and Professional Liability Underwriting Standards include the
following requirements:
A. Quality Control Standards
- regularly survey customers on product and service satisfaction
- monitor customer phone calls for quality of service
- proactively solicit customer registration and communication
- inspect all raw materials and components and institute quality testing as
dictated under Military Standard 105-E for components delivered by
suppliers
- inspect and investigate all returned product and components to allow for
continuous improvement
B. Product Safety
To date, no serious injury from the use of an Xxxxx ErecAid System has ever been
reported from over 450,000 owners. Product design also contributes to user
safety. The vacuum mechanism has a built-in limiter, a vacuum release valve, and
cylinder inserts for appropriate sizing and comfort. To enhance customer safety,
Xxxx Medical retains Board Certified Urologists who educate Xxxx employees,
physicians and the general public on the diagnosis, evaluation and treatment
options. Xxxx'x Medical Directors are also responsible for the administration of
the Certification Board for Urologic Nurses and Associates accredited
certification program. Xxxx Certified Clinical Technicians train and educate
patients on the proper use of the Xxxxx ErecAid System in a clinical setting.
CBUNA is the organization which accredits urology nurses and physician
assistants.
C. Loss Experience
There has never been a claim paid for an injury nor has a lawsuit ever gone to
trial.
D. Approval Listings
The required 510(k) documents were submitted to the U.S. Department of Health
and Human Services, which subsequently determined that all impotence management
products made by Xxxx could be advertised and sold in the marketplace. Marketing
permission is subject to the company's adherence to the general controls
provisions of the Federal Food, Drug and Cosmetic Act. Those provisions include
regulations regarding annual registration, listings of devices, good
manufacturing practices, and specific standards regarding labeling, misbranding,
and adulteration of devices. The Xxxxx ErecAid was the first external vacuum
device to receive marketing approval under federal guidelines.
E. Recall Procedures
The recall policy of Xxxx Medical is in full compliance with the FDA's Recall
Guidelines Section 7.40 of code of Federal Regulation. The company agrees that a
recall, a market withdrawal, or stock recovery is an effective
method of protecting the public health and well being from products deemed to
present a risk of injury, gross deception or other defect.
F. Medically Accredited Training Program and Full Time Medical Staff
Xxxx Medical retains Board Certified Urologists who oversee the accredited
certification program for clinical technicians and technical advisors. This
program is accredited by CBUNA testing body for the urologic health
professionals.
FILE COPY
DEPARTMENT OF VETERANS AFFAIRS
VACUUM ERECTION DEVICES
BLANKET PURCHASE AGREEMENT (BPA)
REQUEST FOR QUOTATION
RFQ NO. NCPR000001 BPA NO. VANAC-90NCPR-02-001
AMENDMENT 1
Several Veteran's Integrated Service Networks (VISN) have committed to purchase
VEDs through VISN level BPAs for a one year period that expires September 30,
2002. These VISNs will not begin to purchase under this BPA until October 1,
2002.
This exclusion could decrease the Government's estimate for the first year of
the BPA by approximately 4,000 units.
Also, this Amendment increases the term of the Blanket Purchase Agreement from
two years to three years.
Since this Amendment may affect prices offered, offerors may change their
offered prices by contacting the Contracting Officer in writing by December 13,
2001.
_____________ We are not changing our original offered price.
______x______ We are changing our original offered price to $89.95.
(Effective until 9/30/02. After September 30, price will
decrease to original proposed bid price of $79.95 for remainder
of 3 year term)
/s/ XXXXXXX X. XXXXXXX
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Signature
Xxxxxxx X. Xxxxxxx
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Name (Printed)
Xxxx Medical Technologies
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Company Name
12-12-01
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Date
