1
Exhibit 10.9
REPROCESSING SERVICES AGREEMENT
This Agreement for Reprocessing Services ("Agreement") is made and entered into
this day of __________, 2001, by and between [Group or Hospital Name, a [State]
corporation, on behalf of its respective wholly owned subsidiary or affiliated
entities listed on Exhibit A (the "Medical Facility"), and Alliance Medical
Corporation ("Alliance").
RECITALS
WHEREAS, Alliance is in the business of providing the delivery of
disposable medical device reprocessing services, and
WHEREAS, Medical Facility agrees to compensate Alliance for services
rendered.
NOW, THEREFORE, in consideration of the foregoing premises and the
terms and conditions contained herein, the parties agree as follows:
ARTICLE I
RELATIONSHIP AND DUTIES OF PARTIES
----------------------------------
1.1. SERVICES
The Services provided under this Agreement include all disposable
medical device-reprocessing programs offered by Alliance to healthcare delivery
entities. The services shall include the cleaning, sharpening and/or functional
testing and reprocessing, sterile packaging and sterilization of Alliance
approved medical instruments as further defined in Exhibit B (the "Services")
which is made part of this Agreement. In consideration of the pricing offered,
Medical Facility agrees that Alliance shall be the exclusive provider of
Services to Medical Facility.
1.2. PRICING
Alliance agrees to provide Services to Medical Facility at the pricing
schedule agreed to and attached to this document as Exhibit C, (the "Pricing
Schedule") which is made part of this Agreement. Alliance will provide quarterly
usage and savings reports to Medical Facility for each of the facilities listed
in Exhibit A that utilize the Services offered under this Agreement.
1.3. WARRANTY
Under this Agreement, Alliance will perform Services in accordance with
the U.S. Food and Drug Administration's (FDA) Quality System Regulation (QSR)
and offer Medical Facility the standard Alliance Warranty for all devices
reprocessed by Alliance as stated in Exhibit D, (the "Alliance Warranty") which
is made part of this Agreement.
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1.4. RETURNS
Medical Facility will receive full credit on account for any item
returned and found not to be clean, sharp, functional, and/or sterile for
single-use, provided that such item has not been or will not be resold,
modified, altered or treated by Medical Facility or any other party.
1.5. PRODUCT LIABILITY INSURANCE
Alliance, at its sole cost and expense, shall procure and maintain
throughout the term of this Agreement, a policy or policies of liability
insurance covering Alliance's activities under this Agreement from an insurance
carrier licensed and authorized to sell or approved to place liability insurance
policies of this nature in the State of [State of Medical Facility] which is
rated by A.M. Best Company, or equivalent insurance rating agency, as "A-", or
better, financial class "VII", or better, and reasonably acceptable to Medical
Facility, and with combined limits not less than $25,000,000. Alliance will also
provide Medical Facility with a "Certificate of Insurance" which verifies the
limits of insurance provided to Medical Facility.
1.6. COMPLIANCE WITH LEGAL AND REGULATORY STANDARDS; CHANGES IN LAW
A. COMPLIANCE.
Alliance agrees to comply with all applicable local, state and
federal laws and regulations governing the Services provided under this
Agreement. This includes, but is not limited to, those outlined,
published, accepted or otherwise adopted by the U.S. Food and Drug
Administration (FDA), the Association for the Advancement of Medical
Instrumentation (AAMI) and the Occupational Health and Safety
Administration (OSHA). Medical Facility agrees to comply with all
applicable local, state and federal laws in connection with the
Services provided under this Agreement.
B. LEGAL EVENT; CONSEQUENCES.
Notwithstanding any other provision of this Agreement, if the
government agencies that administer the Medicare, Medicaid or other
Federal programs (or their representatives or agents) or any other
Federal, State or Local government or non-government agency or any
court or administrative tribunal passes, issues or promulgates any law,
rule, regulation, standard, interpretation, order, decision or
judgment, including but not limited to, those relating to any
regulations pursuant to State or Federal anti-kickback or self-referral
statutes (collectively or individually "Legal Event") which, in the
good faith judgment of one party (the "Noticing Party") materially and
adversely affects either party's licensure, accreditation,
certification or ability to refer, accept for referral, bill, claim,
present a bill or claim or to receive payment or reimbursement from any
Federal, State or Local government or non-government payor, or which
subjects the Noticing Party to a risk of prosecution or civil monetary
penalty or which, in the good faith judgment of the Noticing Party,
indicates a rule or regulation with which the Noticing Party desires
further compliance, then the Noticing Party may give the other party
notice of intent to amend or terminate the agreement in accordance with
the next subparagraph.
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1. NOTICE REQUIREMENTS.
The Noticing Party shall give notice to the other party
together with an Opinion of Counsel setting forth the following
information:
a. The Legal Event(s) giving rise to the notice;
b. The consequences of the Legal Event(s) as to the
Noticing Party;
c. The Noticing Party's intention to either:
(1) Terminate the Agreement due to unacceptable
risk of prosecution or civil monetary
penalty; or
(2) Amend the Agreement, together with a
statement that the purpose thereof is one or
more of the following:
(a) To further comply with any
anti-kickback or Stark II statutory
provisions or rules or regulations
created or affected by the Legal
Event(s); and/or
(b) To satisfy, any licensure,
accreditation or certification
requirements created or affected by
the Legal Event(s); and/or
(c) To eliminate or minimize the risk
of prosecution or civil monetary
penalty.
d. The Noticing Party's proposed amendment(s); and
e. The Noticing Party's request for commencement of the
Renegotiation Period (as defined below).
2. RENEGOTIATION PERIOD; TERMINATION.
In the event of notice under either subparagraph b(2)(a) or
b(2)(b) above, the parties shall have ten (10) days from the giving of
such notice ("Renegotiation Period") within which to attempt to amend
the Agreement in accordance with the Noticing Party's proposal (if any)
or otherwise as the parties may agree. If the Agreement is not so
amended within the Renegotiation Period, the Agreement shall terminate
as of midnight on the tenth (10th) day after said notice was given.
Except as otherwise required by applicable law, any amounts owing to
either party hereunder shall be paid, on a pro rata basis, up to the
date of such termination and any obligation hereunder that is to
continue beyond expiration or termination shall so continue pursuant to
its terms. All Opinions of Counsel presented by the Noticing Party
hereunder, and any corresponding Opinions given by the other party in
response, shall be deemed confidential and given solely for purposes of
renegotiation and settlement of a potential dispute and shall not be
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deemed disclosed so as to waive any privileges otherwise applicable to
said Opinions.
3. Additional Address for Notice.
For purposes of any notices required by this section 1.6, the
following address shall be added to the list of Notice requirements:
Name of Medical Facility
Street Address
City, ST xxxxx
Attn: Primary Contact Person's Name
1.7. CONFIDENTIALITY
A. MEDICAL FACILITY INFORMATION.
Alliance recognizes and acknowledges that, by virtue of
entering into the Agreement and providing Services to Medical Facility
hereunder, Alliance may have access to certain information of Medical
Facility that is confidential and constitutes valuable, special and
unique property of Medical Facility. Alliance agrees that Alliance
shall not, at any time either during or subsequent to the term of the
Agreement, disclose to others, use, copy or permit to be copied,
without Medical Facility's express prior written consent except
pursuant to Alliance's duties hereunder, any confidential or
proprietary information of Medical Facility, including but not limited
to, information which concerns Medical Facility's patients, costs or
treatment methods developed by Medical Facility and which is not
otherwise available to the public.
B. ALLIANCE INFORMATION.
Medical Facility recognizes and acknowledges that, by virtue
of entering into the Agreement and accepting Services from Alliance
hereunder, Medical Facility may have access to certain information of
Alliance that is confidential and constitutes valuable, special and
unique property of Alliance. Medical Facility agrees that Medical
Facility shall not, at any time either during or subsequent to the term
of the Agreement, disclose to others, use, copy or permit to be copied,
without Alliance's express prior written consent except pursuant to
Medical Facility's duties hereunder, any confidential or proprietary
information of Alliance, including but not limited to, information
which concerns Alliance's patents, processes, protocols or costs
developed by Alliance and which is not otherwise available to the
public.
C. NONDISCLOSURE.
Except for disclosure to Alliance's legal counsel, accountant
or financial advisors (none of whom shall be associated or affiliated
in any way with Medical Facility or any of its affiliates), Alliance
shall not disclose the terms of this Agreement to any person who is not
a party or signatory to this Agreement, unless disclosure thereof is
required by law or otherwise authorized by this Agreement or consented
to by Medical Facility.
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Except for the disclosure to Medical Facility's legal counsel,
accountant or financial advisors (none of whom shall be associated or
affiliated in any way with Alliance), Medical Facility shall not
disclose the financial terms of this Agreement to any person who is not
a party or signatory to this Agreement, unless disclosure thereof is
required by law or otherwise authorized by this Agreement or consented
to by Alliance. Unauthorized disclosure of the terms of the Agreement
shall be a material breach of the Agreement and shall provide Medical
Facility with the option of pursuing remedies for breach or immediate
termination of the Agreement.
D. PATIENT INFORMATION.
Alliance shall not disclose to any third party, except where
permitted or required by law or where such disclosure is expressly
approved by Medical Facility in writing (provided Medical Facility
obtains patient consent), any patient or medical record information
regarding Medical Facility patients, and Alliance shall comply with all
Federal and State laws and regulations and all bylaws, rules,
regulations and policies of Medical Facility and Medical Facility's
Medical Staff regarding the confidentiality of such information.
Alliance acknowledges that in receiving or otherwise dealing with any
records or information from Medical Facility about Medical Facility's
patients receiving treatment for alcohol or drug abuse, Alliance is
fully bound by the provisions of the Federal regulations governing
Confidentiality of Alcohol and Drug Abuse Patient Records (42 C.F.R.
Part 2, as amended from time to time).
1.8. COLLECTION AND SHIPPING
A. SHIPPING CHARGES.
Alliance will assume all charges for shipping any collected
product from Medical Facility facilities to Alliance. Return shipments
to Medical Facility facilities will include a flat $9.50 charge and
will be sent standard or "ground" delivery by common carrier. In the
event Medical Facility requires immediate or overnight shipping, any
charges in excess of the flat fee will be the responsibility of Medical
Facility. These additional charges will be added to the facilities
invoice for the order specified as "Rush."
B. COLLECTION.
Alliance agrees to provide Medical Facility with sufficient
packaging and shipping supplies. Medical Facility shall comply with the
shipping and collection protocols (the "Protocols") as provided to
Medical Facility by Alliance
C. ACKNOWLEDGMENT.
Medical Facility acknowledges that Alliance has provided and
Medical Facility has received the Protocols.
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1. Alliance Collection Box:
Services offered under this mechanism require some
level of decontaminated and sorting of collected
instruments. Products are sent directly to the
Alliance processing plant for Services.
2. ORDirect or `Mail-Away' Programs:
Services offered under this mechanism require no
decontamination on the part of Medical Facility.
Collected products are sent directly to one of
Alliance's licensed medical waste facilities operated
in partnership with Stericycle for the sorting and
decontamination of collected product before being
shipped to the Alliance's reprocessing plant in
Phoenix, Arizona.
D. TIME PROVISIONS.
Alliance agrees to provide the Services within six (6) weeks
of receipt of the products from Medical Facility, provided that
Alliance has received a standing/blanket purchase order from Medical
Facility.
1.9. WASTE DISPOSAL AND REMOVAL
All rights to and ownership of any waste that Alliance determines
cannot be reprocessed and returned to Medical Facility shall be transferred to
Alliance upon determination by Alliance that waste cannot be reprocessed. If
such waste needs to be sorted, decontaminated and destroyed, Alliance will
perform these services at no extra charge to Medical Facility. Alliance will
also ensure that waste is destroyed by a licensed medical waste facility and
will keep the required documentation on file to indicate that such waste was
destroyed as required by applicable Federal and State regulations.
1.10. OWNERSHIP OF MEDICAL DEVICES TO BE REPROCESSED
Medical Facility acknowledges that it retains the ownership of the
medical devices and that the Service provided by Alliance is not in violation of
contractual obligations Medical Facility has with the original equipment
manufacturer of the devices that would prohibit the devices' reprocessing.
ARTICLE II
REPRESENTATIONS
---------------
2.1. Alliance represents that it possesses the power and authority to enter into
this Agreement.
2.2. Alliance represents that by entering into this Agreement it will not
violate any of its existing agreements or any of its contractual duties.
2.3. Medical Facility represents that it possesses the power and authority to
enter into this Agreement.
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2.4. Medical Facility represents that by entering into this Agreement it will
not violate any of its existing agreements, contractual duties, or policies.
ARTICLE III
TERM OF AGREEMENT
-----------------
3.1. This Agreement shall remain in force for two (2) years from the date this
Agreement is executed by both parties. This Agreement will renew automatically
at the end of the term and each year thereafter, for an additional year, upon
the written agreement of both parties unless terminated by either party for the
following reason(s):
A. TERMINATION WITHOUT CAUSE.
At any given time, either party may, in its sole discretion,
terminate this Agreement without cause by giving the other party at
least sixty (60) days' prior written notice.
B. TERMINATION FOR BREACH.
Either party may terminate this Agreement upon breach by the
other party of any material provision of this Agreement, provided such
breach continues for fifteen (15) days after receipt by the breaching
party of written notice of such breach from the non-breaching party
(the "Breach Period"). The breaching party may cure such breach prior
to the Breach Period, thereby precluding termination under this
section.
C. EFFECT OF TERMINATION.
As of the effective date of termination of this Agreement,
neither party shall have any further rights or obligations hereunder
except: (1) as otherwise provided in Sections 1.5, 1.7 and 4.2; (2) for
rights and obligations accruing prior to such effective date of
termination including the full payment of invoices for services
rendered up to the time of the termination; or (3) arising as a result
of any breach of this Agreement.
ARTICLE IV
ARBITRATION AND INDEMNIFICATION
-------------------------------
4.1. ARBITRATION
Any controversy or claim arising out of or relating to this Agreement
shall be settled by binding arbitration in accordance with the applicable rules
of the [American Health Lawyers Association] Dispute Resolution Service (the
"DRS") (or, if not then in existence, the American Arbitration Association or a
successor organization of either), or such other rules as may be agreed upon by
the parties, and judgment upon the award rendered by the arbitrators may be
entered in any court having jurisdiction thereof, subject to the following
terms, conditions, and exceptions:
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A. NUMBER OF ARBITRATORS.
There shall be one arbitrator agreed to by the parties from the DRS or,
if the parties cannot agree on one arbitrator, there shall be three (3)
arbitrators whose selection shall be made in accordance with the procedures then
existing for the selection of such arbitrators by the DRS.
B. VENUE.
The venue of any arbitration shall be [County of Medical
Facility] County, [State of Medical Facility] and the arbitration shall
be conducted in accordance with the laws of the State of Arizona.
C. APPLICABLE RULES.
Notwithstanding any provision of Arizona law or the applicable
rules of the DRS to the contrary, each party shall have all of the
rights of discovery pertaining to civil litigation as provided in
Arizona law. Unless the parties otherwise agree in writing, any
arbitration hereunder shall be conducted in accordance with the rules
of evidence existing in the State of Arizona at the time of the
arbitration.
D. COSTS AND EXPENSES.
Each of the parties will share equally in the costs and
expenses of arbitration unless the arbitrators find that the position
of the non-prevailing party in such arbitration was without substantial
justification, in which event the arbitrators may assess all or an
unequal portion of such costs and expenses together with reasonable
attorneys' fees against the non-prevailing party, as the arbitrators
deem equitable.
4.2. INDEMNIFICATION
A. BY ALLIANCE.
Alliance hereby covenants and agrees to protect, defend,
indemnify and hold harmless Medical Facility, its legal
representatives, employees, agents, officers, affiliates and assigns,
and each of them, from and against any claim, loss, damage, cost,
expense or liability, including but not limited to reasonable
attorneys' fees, arising out of or related to the breach of this
Agreement for failure to perform Services and/or dispose of waste
pursuant to Section 1.9. Alliance shall only be liable to Medical
Facility for incidental or consequential damages arising out of or
related to any act or omission of Alliance and Alliance makes no
warranty, express or implied, other than such warranties as expressly
described in this Agreement. This indemnification shall survive
indefinitely.
B. BY MEDICAL FACILITY.
Medical Facility hereby covenants and agrees to protect,
defend, indemnify and hold harmless Alliance, its legal
representatives, employees, agents, officers, affiliates and assigns,
and each of them, from and against any claim, loss, damage, cost,
expense or liability, including but not limited to reasonable
attorneys' fees, arising out of or related
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to the performance or nonperformance by Medical Facility of any
obligations or services to be performed or provided by Medical Facility
under this Agreement. This indemnification shall survive indefinitely.
4.3. GOVERNING LAW.
This Agreement shall be construed in accordance with the laws of the
State of Arizona. The provisions of this paragraph shall survive expiration or
other termination of this Agreement regardless of the cause of such termination.
ARTICLE V
MISCELLANEOUS PROVISIONS
------------------------
5.1. ENTIRE AGREEMENT; MODIFICATION.
This Agreement contains the entire understanding of the parties with
respect to the subject matter hereof and supersedes all prior agreements, oral
or written, and all other communications between the parties relating to such
subject matter. This Agreement may not be amended or modified except by mutual
written agreement.
5.2. REFERRALS.
The parties acknowledge that none of the benefits granted Alliance
hereunder are conditioned on any requirement that Alliance make referrals to, be
in a position to make or influence referrals to or otherwise generate business
for Medical Facility. The parties further acknowledge that Alliance is not
restricted from establishing staff privileges at, referring any patient to, or
otherwise generating any business for any other facility of Alliance's choosing.
5.3. COUNTERPARTS.
This Agreement may be executed in one or more counterparts, all of
which together shall constitute only one Agreement.
5.4. WAIVER.
A waiver by either party of a breach or failure to perform hereunder
shall not constitute a waiver of any subsequent breach or failure.
5.5. SEVERABILITY.
If any provision of this Agreement, or its application to any person or
circumstances, is invalid or unenforceable, then the remainder of this Agreement
or the application of such provision to other persons or circumstances shall not
be affected thereby.
5.6. CAPTIONS.
The captions contained herein are used solely for convenience and shall
not be deemed to define or limit the provisions of this Agreement.
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5.7. ASSIGNMENT; BINDING EFFECT
Alliance shall not assign or transfer, in whole or in part, this
Agreement or any of Alliance's rights, duties or obligations under this
Agreement without the prior written consent of Medical Facility, and any
assignment or transfer by Alliance without such consent shall be void. Medical
Facility shall not assign or transfer, in whole or in part, this Agreement or
any of Medical Facility's rights, duties or obligations under this Agreement
without the prior written consent of Alliance, and any assignment or transfer by
Medical Facility without such consent shall be void. This Agreement shall inure
to the benefit of and be binding upon the parties hereto and their respective
heirs, representatives, successors and permitted assigns.
AGREED TO BY BOTH PARTIES THIS ____________ DAY OF ______________________ 2000.
[NAME OF GROUP/HOSPITAL] ALLIANCE MEDICAL CORPORATION
ON BEHALF OF THEIR SUBSIDIARY
AND AFFILIATED CORPORATIONS
SET FORTH ON EXHIBIT A
By: By:
_______________________________ ____________________________________
Name: Name: John Pirie
_____________________________ __________________________________
Its: Its: Vice President, Corporate Accounts
_____________________________ __________________________________
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Exhibit A
MEDICAL FACILITY FACILITIES & AFFILIATES
FACILITY NAME COUNTY OWNERSHIP NAME
(Corporation unless otherwise indicated)
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Exhibit B
Services
Reprocessing (Previously Used Devices)
CLINICAL AREA
(FDA CATEGORY) FDA PRE- SAMPLE MANUFACTURERS
DEVICE CLASS(es) MARKET NOTES (NOT A COMPLETE LISTING)
- -----------------------------------------------------------------------------------------------------------------------------------
CARDIOVASCULAR
- -----------------------------------------------------------------------------------------------------------------------------------
Aortic Punch I N/A DeKnatel, Medtronic, Portex, Weck
- -----------------------------------------------------------------------------------------------------------------------------------
Chest Retractor/Heart I N/A CTS (Midcab Retractor)
Stabilizer
- -----------------------------------------------------------------------------------------------------------------------------------
Compression Sleeves II 510(k) ALP, Aircast, Gaymar/Plexi-Pulse,
Huntleigh - Flowtron, Kendall,
Venodyne,
- -----------------------------------------------------------------------------------------------------------------------------------
Electrophysiology Catheters II 510(k) - Diagnostic, non-lumened, Cordis Webster, Daig, EP
III PMA non-coated catheters Technologies, Mansfield
only Webster, Medtronic
- -----------------------------------------------------------------------------------------------------------------------------------
SURGERY:
ENDOSCOPIC/LAPAROSCOPIC
- -----------------------------------------------------------------------------------------------------------------------------------
Babcocks II 510(k) - Lumened devices only Autosuture (US Surgical),
Ethicon
- -----------------------------------------------------------------------------------------------------------------------------------
Laparoscopic Clamps II 510(k) - Lumened devices only Ethicon, V. Mueller, Weck
- -----------------------------------------------------------------------------------------------------------------------------------
Laparoscopic Dissectors II 510(k) Autosuture (US Surgical),
Ethicon, Richards
- -----------------------------------------------------------------------------------------------------------------------------------
Laparoscopic Graspers/Forceps II 510(k) - Lumened devices only Aspen, Autosuture (US Surgical),
Corson, Ethicon, Everest Medical,
Marlow, Origin, Richard Allen,
Stryker, Storz, Weck
- -----------------------------------------------------------------------------------------------------------------------------------
Laparoscopic Scissors/Shears II 510(k) - Lumened devices only Aspen, Autosuture (US Surgical),
Corson, Ethicon, Everest Medical,
Marlow, Origin, Richard Allen,
Stryker, Storz, Weck
- -----------------------------------------------------------------------------------------------------------------------------------
Trocars II 510(k) - No devices with chambers Applemed, Autosuture (US Surgical
or valves will be Core, Ethicon, Innerdyne, Lite), Medical,
processed Origin, Richards, Weck
- Applemed products
without sheaths will
not be processed
- -----------------------------------------------------------------------------------------------------------------------------------
Cannula Sets I N/A - Complete sets only Acufex, Applemed, Dyonics,
Linvatec
- -----------------------------------------------------------------------------------------------------------------------------------
Electrodes II 510(k) - Teflon coated electrodes
will not be processed
- -----------------------------------------------------------------------------------------------------------------------------------
Endocautery II 510(k) - No cautery tips or
pencils will be
processed
- -----------------------------------------------------------------------------------------------------------------------------------
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CLINICAL AREA
(FDA CATEGORY) FDA PRE- SAMPLE MANUFACTURERS
DEVICE CLASS(es) MARKET NOTES (NOT A COMPLETE LISTING)
- -----------------------------------------------------------------------------------------------------------------------------------
SURGERY:
ENDOSCOPIC/LAP. (CON'T)
- -----------------------------------------------------------------------------------------------------------------------------------
Harmonic Scalpels II 510(k) - Lumened devices only; Ethicon, Ultracission (LCS)
must include handle and
blade
- -----------------------------------------------------------------------------------------------------------------------------------
Scissors Tips I 510(k) Aspen, Autosuture (US Surgical),
Corson, Ethicon, Everest Medical,
Marlow, Megadyne, Origin, Richard
Allen, Stryker, Storz, Weck
- -----------------------------------------------------------------------------------------------------------------------------------
SURGERY:
GENERAL OR
- -----------------------------------------------------------------------------------------------------------------------------------
Blades II 510(k)
(Cystotome)
- -----------------------------------------------------------------------------------------------------------------------------------
Carpal Tunnel Release I N/A 3M, Micro-Aire
System
- -----------------------------------------------------------------------------------------------------------------------------------
Curettes I N/A Richards, Sklar, Stryker, Zimmer
- -----------------------------------------------------------------------------------------------------------------------------------
Gouges I N/A Codman, Miltex, Richards, Sparta,
Zimmer
- -----------------------------------------------------------------------------------------------------------------------------------
Scissors I N/A Autosuture, Circon, Ethicon,
Everest Medical, Jarit, Pilling
Weck, Richards, Storz, Weck, Zimmer
- -----------------------------------------------------------------------------------------------------------------------------------
Tourniquet Cuffs II 510(k) DePuy, Smith & Nephew, Zimmer
- -----------------------------------------------------------------------------------------------------------------------------------
GASTROENTEROLOGY/UROLOGY
- -----------------------------------------------------------------------------------------------------------------------------------
Biopsy Forceps I N/A - Devices without a handle Americat, Ballard, Bard, Dyonics,
will not be processed Jarit, Medical Innovations,
II 510(k) Microvasive, Olympus, U.S.E.,
Wilson-Cook
- -----------------------------------------------------------------------------------------------------------------------------------
Biopsy Snares I N/A Amercat, Ballard, Bard, Dyonics,
Jarit, Medical Innovations,
II 510(k) Microvasive, Olympus, U.S.E.,
Wilson-Cook
- -----------------------------------------------------------------------------------------------------------------------------------
Cannulatomes/Sphinctertomes II 510(k) Amercat, Ballard, Bard, Dyonics,
Jarit, Medical Innovations,
Microvasive, Olympus, U.S.E.,
Wilson-Cook
- -----------------------------------------------------------------------------------------------------------------------------------
ERCP Cannulas II 510(k) Microvasive
- -----------------------------------------------------------------------------------------------------------------------------------
Electrohemostasis II 510(k) Microvasive
Catheters/Probes
- -----------------------------------------------------------------------------------------------------------------------------------
Guidewires II 510(k) Cook, Meditech, Microvasive
- -----------------------------------------------------------------------------------------------------------------------------------
Laser Fibers II 510(k) Laserscope, Lasersonics
- -----------------------------------------------------------------------------------------------------------------------------------
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CLINICAL AREA
(FDA CATEGORY) FDA PRE- SAMPLE MANUFACTURERS
DEVICE CLASS(ES) MARKET NOTES (NOT A COMPLETE LISTING)
- -----------------------------------------------------------------------------------------------------------------------------------
OPHTHALMOLOGY
- -----------------------------------------------------------------------------------------------------------------------------------
Bipolar Hemostatic Erasers II 510(k) Alcon, Kirwan, Mentor
- -----------------------------------------------------------------------------------------------------------------------------------
Phaco Tips II 510(k) Alcon, Allergan, Surgin
- -----------------------------------------------------------------------------------------------------------------------------------
ORTHOPEDIC/ARTHROSCOPIC
- -----------------------------------------------------------------------------------------------------------------------------------
Arthroscopic Shavers and II 510(k) - Will not process shavers Arthrotek, Baxter,
Burrs that cannot be Concept/Linvatec, Dyonics, Richard,
disassembled (curved) Stryker, Xomed
- -----------------------------------------------------------------------------------------------------------------------------------
Blades
(Cish Blades, Osteotome, Agae, Dyonics, Intek, Padget, 3M,
Tendon Graft Knife, II 510(k) Zimmer, Alcon, Mentor, Richards,
Fasciotomy w/ all pieces) Xomed
- -----------------------------------------------------------------------------------------------------------------------------------
Bovie Hooks (Meniscetomy/ II 510(k) Linvatec, Dyonics
Acromioplasty Electrodes)
- -----------------------------------------------------------------------------------------------------------------------------------
Aesculap, Arvee, Biomet, Codman,
DePuy, Hall, Jedmed, Komet,
Burrs I N/A Linvatec, MedNext, Micro-Aire,
Omega, Richards, Severance,
Stryker, Synthes, 3M, XOMED, Zimmer.
- -----------------------------------------------------------------------------------------------------------------------------------
Cartilage Knives I N/A - Complete sets only Dyonics
- -----------------------------------------------------------------------------------------------------------------------------------
Chisels I N/A Richards, Synthes
- -----------------------------------------------------------------------------------------------------------------------------------
Compression Sleeves II 510(k) See `Cardiovascular' Section Above
- -----------------------------------------------------------------------------------------------------------------------------------
Curettes I N/A Richards, Sklar, Stryker, Zimmer
- -----------------------------------------------------------------------------------------------------------------------------------
Acufex, Anspach, Arthrotek,
Drill Bits Arthrex, Biomet, EBI, Har, Hy,
(Cannulated, Standard, & I N/A Intermedix, IOI, Komet, Leibinger,
Quick-Disconnect) Micro-Aire, Mitek, Omega, Orweth,
Osteomed, Richards, Synthes,
Stryker, 3M, VIT, Zimmer
- -----------------------------------------------------------------------------------------------------------------------------------
External Fixation Devices II 510(k) EBI, Howmedica, Richards, Smith &
Nephew, Orthofix, Synthes, Zimmer
- -----------------------------------------------------------------------------------------------------------------------------------
Guide Pines I 510(k) - Will not process devices Aesculap, Arthrex, Concept,
without calibration Micro-Aire, Richard Allen,
marks Richards, Synthes, Zimmer
- -----------------------------------------------------------------------------------------------------------------------------------
Osteochondral Autograph
Transfer System II 510(k) - Complete sets only Arthex
(Donor/Recipient Devices)
- -----------------------------------------------------------------------------------------------------------------------------------
Rasps I N/A Micro-Aire, Omega, Stryker,
Synthes, 3M, Zimmer
- -----------------------------------------------------------------------------------------------------------------------------------
Reamers - Acetabullar/Patellar I N/A Acufex, Arthrex, Concept, DePuy,
& ACL Linvatec, Richards, Stryker,
Synthes, Zimmer
- -----------------------------------------------------------------------------------------------------------------------------------
Routers I N/A Concept, Synthes
- -----------------------------------------------------------------------------------------------------------------------------------
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CLINICAL AREA
(FDA CATEGORY) FDA PRE- SAMPLE MANUFACTURERS
DEVICE CLASS(ES) MARKET NOTES (NOT A COMPLETE LISTING)
- -----------------------------------------------------------------------------------------------------------------------------------
Orthopedic/Arthroscopic
(Con't.)
- -----------------------------------------------------------------------------------------------------------------------------------
Aesculap, Anspach, Arthrex, Biomet,
Black and Decker, Concept, Dyonics,
Hall, Howmedica, Intermedics, J & J,
Saw Blades I N/A Komet, Micro-Aire, Omega,
Richards, Somen-Geneva, Stryker,
Synovasive, Synthes, UAM, Zimmer
- -----------------------------------------------------------------------------------------------------------------------------------
Cannula Sets I N/A - Complete sets only Acufex, Dyonics
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Skill Pins II 510(k)
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Taps I N/A Micro-Aire, Omega, Richards,
Stryker, Synthes, Zimmer
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Trephine I N/A Anspach, Micro-Aire, Midas Rex,
Richards, Zimmer
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PLASTIC SURGERY
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Dermatome Blades I N/A
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NEUROLOGY
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Burrs II 510(k) See `Orthopedic/Arthroscopic'
Section Above
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Drill Bits II 510(k) See `Orthopedic/Arthroscopic'
Section Above
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Skull Pins II 510(k)
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GENERAL NOTES FOR ALL CATEGORIES
--------------------------------
- Devices without manufacturer's part number will not be processed
- Devices with batteries will not be processed
- Devices with pressure cartridges will not be processed
`FULL PROCESS' involves the cleaning, functional testing, packaging,
sterilization of a previously used device.
If you do not see a particular device you are interested in reprocessing, please
contact your Alliance sales professional. She/He will work with you and our
in-house engineers to evaluate the product.
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Resterilization/Repackaging (Unused Products)
ALLIANCE MEDICAL CORPORATION IS ABLE TO SERVICE MOST OPEN/UNUSED
DEVICES EXCEPT THE FOLLOWING:
Devices with batteries
Devices with pressure cartridges
Devices with filters
Devices requiring radiation sterilization
Coated devices, e.g., heparin, barium, collagen
Ballooned devices, e.g., Catheters
Devices with latex components
Drapes and Gowns
Fascial and Subcutaneous Staplers
Linear Cutters with Absorbable Staples
Absorbable Pins
Implants, e.g., stents, vascular grafts
Suture within 3 months of expiration date
Vicryl relay sutures not in foil packages
Kits and packs without list of contents
(medications, betadine, paint, any wooden components, hemostatic agents and
bone cement will be removed)
`OPEN/UNUSED' (Resterilization) refers to the repackaging and resterilization of
a device that has not been used on a patient.
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17
Exhibit C
Pricing Schedule
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Exhibit D
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ALLIANCE WARRANTY
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Under this Agreement, Alliance Medical Corporation (ALLIANCE) will reprocess
medical instruments, including cleaning, sharpening and sterilization, in
accordance with FDA Guidelines for Quality System Regulations.
ALLIANCE warrants the STERILITY of reprocessed medical instruments unless the
packaging of the medical instrument has been damaged or opened. ALLIANCE
warrants the FUNCTIONALITY of reprocessed medical instruments until such medical
instruments have been used in one medical procedure. ALLIANCE shall refund the
cost of reprocessing any medical instrument that does not meet the total
satisfaction of MEDICAL FACILITY.
MEDICAL FACILITY acknowledges that ALLIANCE performs a service, and that MEDICAL
FACILITY retains the title and ownership of all medical instruments under this
Agreement.
MEDICAL FACILITY represents that by providing the medical instruments to
ALLIANCE for cleaning and reprocessing, MEDICAL FACILITY is not breaching any
contractual obligations to the original manufacturer, which prohibits the
reprocessing of medical instruments.
ALLIANCE shall indemnify and hold harmless MEDICAL FACILITY against all claims,
demands and liability, all sums for which MEDICAL FACILITY shall become legally
obligated to pay as damages caused by bodily injury to patients as a result of
ALLIANCE's performance of services under this Agreement. This indemnity and hold
harmless obligation shall not apply to damages arising out of misuse of any
medical instruments which are the subject of this Agreement. ALLIANCE shall only
be liable to Medical Facility for incidental or consequential damages arising
out of or related to any act or omission of ALLIANCE and ALLIANCE makes no
warranty, express or implied, other than such warranties as expressly described
in this Agreement.
ALLIANCE does not warrant reprocessed or cleaned medical instruments which have
been or will be resold, modified, altered or treated by MEDICAL FACILITY or any
other party.
Terms and conditions of this Service Agreement also appear on the packaging for
each medical instrument reprocessed by ALLIANCE.
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