EXHIBIT 10.30
STANDARD TERMS AND CONTRACT FOR USE
OF LADARVISION-Registered Trademark- SYSTEM
THIS AGREEMENT IS PRESENTED IN "PLAIN ENGLISH" BY ATC IN AN EFFORT TO
SIMPLIFY THE AGREEMENT
PARTIES
-------
Autonomous Technologies Corporation ("ATC" or "Autonomous") located at 0000
Xxxxxxxxx Xxxxx, Xxxxxxx, XX 00000 and TRUEVISION INTERNATIONAL ("Account" or
"Customer") located at 0000 XXXXXXXXX XXXX., #000, XXXXXXXXXXX, XXX XXXXXX,
00000.
PRODUCT AND LOCATION
--------------------
The "System" is the LADARVision-Registered Trademark- Tracker-Guided Excimer
System as described in Exhibit A. The location of the System will be:
RAINBOW CORPORATE CENTER, 000 XXXXXXX XXXX, XXX XXXXX, XX 00000
(Address of Site)
SHIP DATE
---------
On or before: SEPTEMBER 30, 1999
ATC is responsible for all shipping costs including crating, transportation,
and insurance while machine is in transit. Costs beyond normal shipping
charges will be absorbed by Customer. Examples of additional possible costs
are as follows but not limited to: cranes or other special rental equipment
for installation; removal of walls, doors, or windows; accelerated delivery
at clients request (i.e., air shipments).
Upon signing of contract and prior to delivery of the LADARVision unit, our
insurance carrier requires that a certificate of insurance be provided to
Autonomous. This certificate should include the following 2 items: 1)
Commercial General Liability Insurance naming Autonomous as "Additional
Insured Lessor" and 2) Property Insurance naming Autonomous as "Additional
Loss Payee".
CONTRACT
--------
Autonomous agrees to supply Account with a System for use for a period of 36
months (the "Contract Period") subject to the terms of this Agreement.
PATENT LICENSE
--------------
Subject to ("Account" or "Customer") execution of an Autonomous Laser Patent
and Software License agreement (Exhibit B) in form acceptable to Autonomous,
the procedure fee for the use of the System provides licenses to all
applicable system software, Autonomous patents, Summit patents, and Visx
patents.
Page 1 of 6
SERVICES AND MAINTENANCE PROVIDED BY AUTONOMOUS
-----------------------------------------------
All service, parts, maintenance, gases, optics for contracted model.
On-site service response time within 48 hours.
UPGRADES PROVIDED
-----------------
Future software upgrades for the System, including hyperopia, if, as, and
when approved. (Does not include CustomComea-Registered Trademark-)
TRAINING
--------
Autonomous will provide one training session for up to 6 individuals to use
the System at the Account's site. Additional training sessions can be
requested by the Account at a per diem cost plus expenses.
CREDITS FOR RETREATMENTS/ENHANCEMENTS
-------------------------------------
All procedures, including retreatments, are prepaid by the Account at the
current contracted rate. Upon submission of the appropriate documentation,
(Exhibit C), credits will be issued as follows:
- Eyes previously treated with ATC system: full credit
- Eyex treated on another excimer system by ATC-qualified doctors at the
Site within 12 months of System installation will be issued a credit to
reduce the net cost of $300 per eye.
Retreatments cannot be counted towards the Minimum Quarterly Procedure Volume
(1/4 of the Annual Minimum Procedure Volume).
AFFILIATE FEE SCHEDULE
----------------------
Account commits to one of the following Pricing Classes:
SPECIAL AAO '98 INTRODUCTORY PRICING SCHEDULE
---------------------------------------------
PRICING CLASS ANNUAL MINIMUM/MAXIMUM PROCEDURE INITIAL PAYMENT:
MINIMUM VOLUME AND PER PROCEDURE FEE MONTHLY PREPAYMENT
CLASS I 600- 749/YR. @ $500 PER PROCEDURE $25,000
CLASS II 750- 999/YR. @ $475 PER PROCEDURE $29,688
CLASS III 1,000-1,149/YR. @ $400 PER PROCEDURE $33,333
CLASS IV 1,150-1,299/YR. @ $375 PER PROCEDURE $35,938
CLASS V 1,300-1,999/YR. @ $350 PER PROCEDURE $37,917
CLASS VI 2,000+/YR.@ $300 PER PROCEDURE $50,000
CLASS SELECTED
--------------
Account hereby elects the following Pricing Class: ________ (please initial)
Page 2 of 6
MINIMUM REQUIRED PAYMENTS
-------------------------
Account agrees to pay for 50 procedures per month for a minimum total of 600
procedures per year at the Minimum Monthly Prepayment of $25,000 (plus sales
tax if applicable) for Pricing Class I selected. Minimum Monthly Prepayments
are calculated by taking the minimum volume for the Pricing Class, multiplying
by the Per Procedure Fee and dividing by 12.
The Account may elect to move to a higher Pricing Class at the following
times:
- The beginning of each quarter for the first year only. For this year, the
Annual Minimum Procedure Volume will be the sum of the Minimum Quarterly
Procedure Volume for the four quarters.
- The first month for years two and three
Activating these options automatically raises the Minimum Monthly Prepayment
to the one listed for the Pricing Class chosen.
Notification of the selection of a higher Pricing Class must be received in
writing by ATC no later than 30 days prior to the periods designated for such
elective changes. See above.
In the event the system is not operable for longer than 5 working days,
minimums for that month will be prorated upon receipt of reasonable
documentation by ATC for missed surgeries that could not be rescheduled within
the quarter and subsequently lost to the market. Such credits will be noted
in the first month of the following quarter.
-----------------------------------------------------------------------------------
AFFILIATE PREPAYMENTS
-----------------------------------------------------------------------------------
-----------------------------------------------------------------------------------
- LAST MONTH'S MINIMUM MONTHLY PREPAYMENT $ 25,000.00
- APPLICABLE SALES/USE TAX (7.25%) $ 1,812.50
- LESS DEPOSIT WITH LETTER OF INTENT $ (10,000.00)
TOTAL DUE AT CONTRACT SIGNING (LAST MONTH OF CONTRACTED
MINIMUM MONTHLY PREPAYMENT LESS $10,000 INITIAL DEPOSIT, PLUS TAX) $ 16,812.50
-----------------------------------------------------------------------------------
-----------------------------------------------------------------------------------
- FIRST MONTH'S MINIMUM MONTHLY PREPAYMENT $ 25,000.00
- APPLICABLE SALES/USE TAX (7.25%) $ 1,812.50
TOTAL DUE 30 DAYS PRIOR TO SHIP DATE (FIRST
MONTH'S MINIMUM MONTHLY PREPAYMENT) $ 26,812.50
-----------------------------------------------------------------------------------
-----------------------------------------------------------------------------------
TOTAL DUE FOR FIRST AND LAST MINIMUM MONTHLY PREPAYMENTS $ 43,625.00
-----------------------------------------------------------------------------------
BILLING
-------
Billing period starts at the time of "Installation and Acceptance" of the
System (Exhibit D) by the Account.
Page 3 of 6
The Account agrees to pay the Minimum Monthly Prepayment for the Pricing
Class selected, which will remain fixed for the entire Contract Period unless
the Account elects a higher Pricing Class at the times specified in the
Minimum Required Payments section.
On the 10th of each month, the Account will receive an invoice for the
following month's Minimum Monthly Prepayment. Monies are due net 15 days
following receipt of invoice. Late payments will result in late fees of 1.5%
per month.
An invoice for the second month's Minimum Monthly Prepayment will be issued
at the time of "Installation and Acceptance" and be adjusted to reflect the
pro-rata credit due as a result of a difference in the date of System
"Acceptance" at the Site and the total number of days in the month of
installation.
Every three months, ATC will reconcile on a quarterly and year-to-date basis
the actual procedures performed against the Minimum Monthly Prepayments.
Procedures performed in excess of those covered by the total quarterly and
year-to-date Minimum Monthly Prepayments will be billed at the rate of the
Pricing Class selected and noted on a separate Quarterly Adjustment Xxxx,
payable net 15 days after receipt. Credits due the Account as a result of a
variance between total billed procedures, Minimum Monthly Prepayments and
actual year-to-date procedures performed will be issued on the next
Quarterly Adjustment Xxxx.
No credit will be issued if fewer procedures are performed than the number
paid for by the quarterly and year-to-date Minimum Monthly Prepayments. The
Account may not credit excess monthly or quarterly procedures against the
next month's billing to reduce the Minimum Monthly Prepayment.
Procedures completed over the Annual Maximum Procedure Volume for the Pricing
Class selected will be eligible for the reduced Per Procedure Fee of the next
Pricing Class. Any credits due as a result of these lower Per Procedure Fees
will be calculated and given at the end of the quarter in which they occurred.
At the end of the third and final year of the contract, any such credits will
be refunded to the Account.
Applicable local, state, personal property and sales/use taxes must be paid
by Account and will be added to the Minimum Monthly Prepayments and to the
Quarterly Adjustment Bills.
ATC shall have the right to deactivate or remove the System if Account is
late in paying two consecutive payments. In such event, Account will be
responsible for paying the Early Termination Fee (Exhibit E).
SITE REQUIREMENTS
-----------------
The Account shall prepare, maintain, and use the Site according to the
attached LADARVision-Registered Trademark- System Site Requirements
(Exhibit F).
Failure of the Site to meet the Site Requirements prior to Ship Date may
result in the Ship Date being postponed by ATC.
Page 4 of 6
If, after inspection of the Site by ATC, Account wishes the System to be
installed in a different location, either at the same Site or a different
Site altogether, Account must notify ATC of new location at least 90 days
prior to Ship Date. Failure to do so may result in a postponement of Ship
Date.
QUALIFIED USERS
---------------
Only persons trained and certified by ATC or by an ATC-designated trainer
shall be permitted to use the System; System must be used in accordance with
Operator's Manual.
WARRANTY
--------
Autonomous warrants that the System is free of defects in material and
workmanship and that the System will operate according to the Operator's
Manual. Warranty valid only if the System is operated in accordance with the
Operator's Manual. AUTONOMOUS MAKES NO WARRANTY OF MERCHANTABILITY OR ANY
OTHER WARRANTY, EXPRESSED OR IMPLIED.
SYSTEM DISCLOSURE
-----------------
The System may be new or refurbished, and may contain new or refurbished
parts.
LIMITATION OF LIABILITY
-----------------------
Autonomous shall not be liable for consequential or incidental damages caused
by either a defect in the System or an uncured breach of the Contract or
actual, consequential, or incidental damages resulting from a force majeur.
OWNERSHIP OF THE SYSTEM AND STUDY RESULTS
-----------------------------------------
Autonomous maintains title to and ownership of the System (hardware and
software) and any results of studies commissioned by ATC during and following
termination of this Contract. Account agrees to permit ATC personnel access
to the System at all times for the purpose of servicing and supporting the
System.
CONTRACT ASSIGNMENT
-------------------
The Account may not assign this Contract.
TERMINATION RIGHTS
------------------
The Account may not terminate this Contract unless ATC breaches this Contract
in some significant way and has had a reasonable opportunity to cure the
breach.
EARLY TERMINATION BY ATC: EARLY TERMINATION FEE
-----------------------------------------------
Autonomous may terminate this Contract or remove the System, or both, upon a
significant breach of any term by the Account. If the breach is capable of
being cured, Account shall be given a reasonable opportunity to cure the
breach. If Autonomous terminates this Contract due
Page 5 of 6
to a breach by the Account, the Account shall pay to Autonomous the early
Termination Fee set forth on Exhibit E.
CONTRACT CONFIDENTIALITY
------------------------
Both parties agree to maintain the confidentiality of the terms of this
Contract and Operator's Manual. If Account violates this Confidentiality
provision, ATC can terminate this Contract and Account will be responsible
for payment of the Early Termination Fee.
EFFECTIVE DATE
--------------
The above terms constitute an agreement between Autonomous Technologies
Corporation and TRUE VISION INTERNATIONAL ("Account" or "Customer"),
effective as of ___________________________.
AUTONOMOUS TECHNOLOGIES (ACCOUNT/CUSTOMER)
CORPORATION
By: By: [ILLEGIBLE]
----------------------------- -----------------------------
Title: Title: PRESIDENT
----------------------------- -----------------------------
Page 6 of 6
AUTONOMOUS
GET THE VISION
CONTRACT EXHIBITS PACKAGE
The following Exhibits are referenced in Contract
Exhibit A - LADARVision Specifications
Exhibit B - Autonomous Laser Patent and Software License
Exhibit C - Documentation Required to Issue Credit for Retreatments
Exhibit D - Installation and Acceptance Checklist
Exhibit E - Early Termination Fee
Exhibit F - LADARVision System Site Requirements
EXHIBIT A
SYSTEM SPECIFICATIONS
HARDWARE CHARACTERISTICS
Excimer (Corneal Scultping) Laser(1)
ATF EXCIMER LASER @ 193 NM
DUAL AXIS PRECISION SCANNER
SMALL BEAM (Less Than 1MM DIAMETER)
WITH SMOOTHING ALGORITHM
LADARVision-Registered Trademark- Eye Tracker(1)
SURGEON DETERMINED CENTRATION
SACCADE SENSITIVE TRACKING SYSTEM
UP TO 4000 SAMPLES/SECOND
Direct View Optics(1)
STEREO MICROSCOPE WITH ZOOM
PATIENT FIXATION TARGET
Operator's Computer Station
GRAPHICAL USER INTERFACE - ACCESSIBLE
- PATIENT DATABASE
- QUICK AUTOMATED CALIBRATION
- ALL SURGICAL PARAMETERS
Installation Parameters
STANDARD AC POWER
COMPACT FOOTPRINT
SOLID CONSTRUCTION
PHYSICIAN OFFICE COMPATIBLE
Patient Safety
EVEN IF -
- LOSS OF POWER
- SOFTWARE SHUTDOWN
- MOVING OBJECT INTO FIELD
- PATIENT MOVING OUT OF FIELD
- FOOT COMING OFF FOOT SWITCH
SURGERY CAN BE RESTARTED FROM
EXACT POINT OF INTERRUPTION
FUNCTIONAL CHARACTERISTICS
MYOPIA, ASTIGMATISM (HYPEROPIA, LASIX)(2)
AVERAGE FLUENCE 200 MJ/CM(2)
UP TO 10 MM SCANNED ALBATION ZONE
Less Than 10 SECONDS/DIAPTER FOR 6 MM ZONE OF MYOPIA
TRACKS SACCADIC EYE MOVEMENT
HIGH PRECISION @ 100 DEGREES/SECOND
TRACKER STABLIZIED COLOR VIDEO
EXIMER BEAM CAN BE ALIGNED EXACTLY TO ON-AXIS POSITION
DIRECT VIEW COLOR VIDEO
FINE ALIGNMENT FOR TRACKER ACQUISITION
EASY-TO-USE WINDOWS(2) ENVIRONMENT
PATIENT RECORD RETRIEVAL
ABLATION TEST PLATES
110 VOLTS AC: 60HZ OR 200-240 VAC, 50HZ
1.0M WIDE x 2.4M LONG x 1.5 HIGH
363KG
TRACKER ENSURES ACCURACY & PRECISION
------------------------------------------------------------------------------
------------------------------------------------------------------------------
(1) Patents Pending on LADARVision-Registered Trademark- Laser Scanner, Scan
Pattern, Fixation Target and Optics (2) CAUTION Investigational Device.
Limited by U.S. Federal Law to Investigatorial Use.
EXHIBIT B
---------
AUTONOMOUS LASER PATENT AND SOFTWARE LICENSE
--------------------------------------------
Authorized Licensee: ("Licensee") System Model: (The "System")
--------------------------------- ----------------------------
TRUE VISION INTERNATIONAL LADARVision-Registered Trademark-
0000 XXXXXXXXX XXXX XX, XXX 000
Xxxxxxxxxxx, XX 00000 Serial Number:
--------------------------------------
Initial Installation Site: ("Site") Authorized Users: ("Authorized Users")
----------------------------------- --------------------------------------
RAINBOW CORPORATE CENTER --------------------------------------
000 Xxxxxxx Xxxx
Xxx Xxxxx, XX 00000 --------------------------------------
--------------------------------------
License Fees: As set forth in standard Terms and Contract for the use of
Autonomous Technologies Corporation LADARVision System between Autonomous and
Licensee dated _________________ ("Use Agreement").
1. The System, certain related disposables and their use are covered by
several United States patents for which Autonomous has the authority to
provide this license. The patents cover methods and apparatus for
performing ophthalmic laser surgery. A list of these Patents is attached
as Schedule A ("Patents"). Use of the System to perform any procedure
covered by the Patents is prohibited unless such use is authorized by a
valid Autonomous Laser Patent License. The sale, lease or other placement
of the System by Autonomous does not in any way grant a license under any
Patent to use the System to perform any procedures. Such license may only
be granted by the execution and delivery by Autonomous of an Autonomous
Laser Patent License.
2. Subject to Licensee's compliance herewith, Autonomous hereby grants to
the Licensee the right under the Patents to permit the Authorized Users
to use the System and related disposables to perform at the site any
ultraviolet laser corneal surgery procedure that is covered by at least
one claim of a Patent ("Licensed Procedure"). In consideration of the
grant of the rights to use the Software and to perform Licensed
Procedures covered by the Patents, Licensee shall pay the License Fee set
forth above on the front page of this License each time the System is
used to perform a Licensed Procedure. Payment terms will be as set forth
in the Use Agreement. If Autonomous hereafter is granted or acquires any
additional patents covering apparatus or procedures for performing
ophthalmic procedures with the System or otherwise obtains the right to
provide licenses of any such patents, it shall make licenses thereof
available to Licensee on terms to be determined by Autonomous at that
time.
3. The following provisions apply to the software incorporated in the System
(including any upgrades, modifications or enhancements which may be
incorporated in the future):
(a) The System includes a copy of computer software and may be upgraded
to include additional software (the "Copy"). All such software (the
"Software") is protected under copyrights, trade secret rights and
other proprietary rights owned by or licensed to Autonomous
(collectively, the "Autonomous Rights").
(b) Autonomous licenses the Copy to Licensee and, to the extent that it
has the right and power to do so, grants Licensee the non-exclusive
right and license under the Autonomous Rights to use the Copy solely
(i) for the purpose of using the System to perform Licensed
Procedures, or (ii) in connection with the maintenance of the System
by Autonomous or by a third party expressly licensed by Autonomous
to use such Copy for maintenance. Notwithstanding any other
provision of this Agreement, as between Autonomous and Licensee,
Autonomous retains title to and ownership of the Copy and of all
Autonomous Rights.
(c) Except as expressly provided in Section 3(b), Autonomous does not
grant Licensee right to license under the Autonomous Rights,
including without limitation any right or license to copy, create
derivative works based on, distribute, or publicly display or
perform the Software or Copy, except that Autonomous grants Licensee
a non-exclusive license to create copies of the Software
1
(or parts thereof) in Random Access Memory to the extent that doing
so is a necessary step in using the Copy for the purposes authorized
under paragraph 3(b) (the "RAM Copy License"). The RAM Copy Licenses
may not be assigned, sublicensed or otherwise transferred without
Autonomous' prior written consent.
4. Licensee shall permit only ophthalmologists who are legally qualified,
properly licensed and fully trained to perform Licensed Procedures with
the System.
5. The Authorized Users are named above. Licensee may, by providing 10 days
prior written notice to Autonomous, add or delete practitioners from the
list of Authorized Users who are permitted to perform Licensed Procedures
with the System.
6. Licensee shall not move the System from the Site unless it provides at
least 30 days prior written notice of the new site to Autonomous and has
obtained the prior written consent of Autonomous to such move. In the
event the System is moved from the Site in violation of this provision,
then, in addition to all other rights and remedies at law and equity
which may be available to Autonomous, Autonomous shall have the right to
enter upon the premises where the System is located and seize the System
or disable the System from performing additional procedures.
7. Licensee may not sell or otherwise transfer the System unless the
proposed transferee has first entered into the then current form of
Autonomous Laser Patent License for the System. Licensee may not transfer
or sublicense any of its rights or obligations hereunder without
Autonomous' prior written consent, except as may be implicit in its
granting the Authorized Users the privilege to use the System pursuant
hereto. In the event the System is sold or transferred in violation of
this provision, then, in addition to all other rights and remedies at law
and equity which may be available to Autonomous, Autonomous shall have
the right to enter upon the premises where the System is located and
seize the System or disable the System from performing additional
procedures.
8. Licensee shall allow Autonomous, at Autonomous' sole expense, from time
to time to install or to attach to the System, and to modify, adjust and
read, a memory, recording or other device and/or software (including
telephone connections of the devices with Autonomous) which measures the
number and types of Licensed Procedures performed with the System.
Licensee shall not permit anyone other than an authorized Autonomous
representative to tamper with, alter or remove any such devices or
software. In the event Autonomous determines that any such devices or
software have been tampered with, altered or removed, or that such
tampering, alteration or removal has been attempted, then, in addition to
all other remedies at law and equity which may be available to
Autonomous, Autonomous shall have the right to enter upon the premises
where the System is located and seize the System or disable the System
from performing additional procedures. Further, such actual or attempted
alteration, removal or tampering shall constitute presumptive evidence of
Licensee's intentional infringement of the Patents.
9. Licensee shall comply with, and shall cause each Authorized User to
comply with, all applicable laws affecting the System, including, without
limitation, the Federal Food, Drug, and Cosmetic Act as well as all
applicable rules, regulations and any labeling promulgated thereunder.
Licensee shall not remove or tamper with any label affixed to the System.
Licensee and the Authorized Users shall use the System in accordance with
Autonomous' user's manual as same may from time to time be amended.
10. This License will continue until the expiration of the last of the
Patents and Licensee's obligation to pay Procedure Royalties shall
terminate for a given procedure on the expiration of the last of the
Patents containing one or more method claims which cover such procedure.
This License may be terminated at any time by Autonomous if (a) Licensee
fails to make any payment due hereunder within 30 days of the due date or
(b) Licensee fails to cure any other breach hereof within 30 days after
Autonomous provides written notice of such breach to Licensee. Upon any
early termination Licensee and all Authorized Users shall cease all use
of the System, and the provisions of this agreement shall survive.
11. Licensee shall allow Autonomous' duly identified representatives access
to the System at mutually convenient times during reasonable business
hours upon at least 24 hours notice to obtain monitored information and
to assess Licensee's compliance with this License. In the event
Autonomous is denied access to the System in violation of this provision,
then, in addition to all other rights and remedies at law and equity
which may be available to Autonomous, Autonomous shall have the right to
enter upon the
2
premises where the System is located and seize the System or disable the
System from performing additional procedures.
12. This agreement between Autonomous and Licensee is binding on their
respective successors and assigns and legal representatives. This License
is subject to and interpreted under the laws of the Commonwealth of
Massachusetts (without regard to principles of conflict of laws), cannot
be amended, nor can any term be waived, except in a writing signed by
both parties. No waiver or modification in any one instance shall be a
waiver or modification in any other. No third party rights will be
created by the execution or performance of this License. This License
contains the entire understanding between Autonomous and Licensee with
respect to its subject matter and supersedes all other agreements,
discussions, and understandings with respect to the subject matter.
Licensee acknowledges that Autonomous' legal remedies hereunder are
inadequate to protect Autonomous' interests in the event of any breach
hereunder by Licensee and that, in addition to any other remedies against
Licensee which may be available to Autonomous in such event, Autonomous
shall be entitled to equitable, including injunctive, relief. Notices
hereunder shall be sent by reputable overnight courier to the principal
offices of the subject party.
13. So long as the Licensee and its Authorized Users comply in full with this
License Agreement, the Licensee and the Authorized Users are hereby
granted immunity from any infringement or other legal action under the
Patents, although Autonomous makes no representation or warranty
regarding the scope or validity of any of the Patents or that the System
or its use is free of infringement of third party rights. No implied
licenses are created hereby.
Executed under seal.
AUTONOMOUS TECHNOLOGIES CORPORATION LICENSEE:
By: _____________________________
Title: __________________________
[Performance of all of the obligations of Leasing Party hereunder are
unconditionally guaranteed by
By: /s/ Xxxx [illegible]
______________________________
Name (Printed): Xxxx [illegible]
__________________
Title: President
__________________________
Date: 7/ /99 ]
__________________________
3
SCHEDULE A
----------
UNITED STATES PATENTS
PATENT NUMBERS
--------------
4,665,913 5,312,330
4,669,466 5,473,392
4,718,418 4,388,924
4,721,379 5,312,330
4,729,372 5,360,424
4,732,148 5,395,356
4,773,414 5,395,363
4,798,204 5,411,501
4,842,360 5,437,658
4,856,513 5,461,212
4,902,122 5,613,965
4,903,695 5,651,784
4,911,711 5,772,656
4,941,093 5,098,426
4,973,330 5,865,832
4,994,058
5,019,074
5,108,388
5,147,352
5,163,934
5,188,631
5,207,668
5,219,343
5,219,344
5,312,320
5,334,190
5,423,801
5,324,281
5,507,741
5,549,597
5,556,395
5,711,762
5,713,892
5,735,843
5,795,351
5,807,379
5,442,412
5,594,753
5,632,742
5,740,803
5,752,950
5,828,686
5,849,006
5,505,723
5,437,658
4
EXHIBIT C
---------
DOCUMENTATION REQUIRED TO ISSUE CREDIT FOR
RETREATMENTS
PATIENT NAME__________________________________________________________________
LASER USED____________________________________________________________________
LOCATION OF LASER_____________________________________________________________
SUREGON PERFORMING RETREATMENT PROCEDURES_____________________________________
DATE OF FIRST SURGERY_________________________________________________________
(Please attach surgery print-out copy)
- PRE-OP REFRACTION___________________________________________________________
- PRE-OP UCVA_________________________ PRE-OP BCVA____________________________
- TREATMENT CORRECTION________________________________________________________
i.e. does this differ from pre-op (monovision or nomogram adjustment)
DATE OF SECOND SURGERY________________________________________________________
(Please attach surgery print-out copy)
- POST-OP REFRACTION AT LAST VISIT PRIOR TO TREATMENT_________________________
- THIS VISIT: POST-OP UCVA____________ POST-OP BCVA___________________________
- RETREATMENT CORRECTION______________________________________________________
REASON FOR RETREATMENT; I.E. PATIENT PREFERENCE, UNDERCORRECTION, REGRESSION,
ETC.
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
EXHIBIT D
---------
AUTONOMOUS
GET THE VISION
CERTIFICATE OF INSTALLATION & ACCEPTANCE
This Certificate of Installation & Acceptance confirms that your LADARVision
System has been delivered and installed, you have completed In-service and
Clinical training, and the system is functioning according to Autonomous
Technology installation specifications.
Serial #: _____________________________ Date: _____________________________
City/Country: _________________________ Part Number: ______________________
Autonomous Technologies Representative:_______________________________________
Customer Representative: _____________________________________________________
Autonomous Customer Support
0000 Xxxxxxxxx Xxxxx
Xxxxxxx, Xxxxxxx 00000
Tel 877-LADARVision
Fax 000 000-0000
xxx.xxxxxxxxxx.xxx
EXHIBIT E
---------
EARLY TERMINATION FEE
In the event ATC terminates this Contract as a result of a breach by the
Account, the Account shall pay to ATC within ten days following such
termination an Early Termination Fee determined by the table below:
NOTIFICATION PERIOD* AMOUNT
------------------- ------
(1-3 months) $300,000
(4-6 months) $276,000
(7-9 months) $249,000
(10-12 months) $225,000
(13-15 months) $201,000
(16-18 months) $174,000
(19-21 months) $150,000
(22-24 months) $126,000
(25-27 months) $ 99,000
(28-30 months) $ 75,000
(31-33 months) $ 51,000
(34-36 months) $ 24,000
*The number of months in the Notification Period refers to the number of
months after commencement of the contract during which terminaiton occurs.
EXHIBIT F
---------
LADARVISION SYSTEM SITE REQUIREMENTS
The site requirements described below ensure that the LADARVision-Registered
Trademark- System will meet all performance and quality requirements at the
time of installation and provide the customer with the best possible
long-term reliability.
1. ROOM REQUIREMENTS
a) The required minimum floor area is 11 feet by 14 feet (3.3 meters by
4.3 meters). See attached floor plan (Figure 1) for door, electrical,
cabinet, and sink placement options, a plan view of the System and
the recommended layout and dimensions for the laser room.
b) The surface of the walls and ceiling should not produce dust from
wallpaper and other coverings.
c) Linoleum or tile should be used instead of carpet for flooring, then
sealed and waxed to reduce dust. The floor must be a solid foundation
capable of supporting the 800 pound (363 kilograms) System weight.
d) The door of the surgery room must be lockable with a rubber wiper on
the bottom to form a seal. A sink in the room is recommended, but not
required.
2. SAFETY
a) All local laser safety regulations and standards must be observed.
b) In case of a gas leak inside the laser enclosure, an internal
scrubber is provided. During gas bottle replacement, a leak is
possible. Ventilation to the exterior or a stand-alone air purifier
to change the air in the room must be supplied. When venting to the
exterior, make sure it is in compliance with local air quality
regulations. If an air purifier is used, an activation switch should
be mounted within easy access to the exit door.
c) A Halon or equivalent fire extinguisher that is appropriate for use
near electrical equipment needs to be present in the surgery room.
3. ENVIRONMENT
a) The air must be clean (free of dust, soot, and vapors from adhesives,
grease or volatile organic chemicals). An air filter that removes a
minimum of 30% of all particulate for each cycle of air is required.
b) The room must be climate controlled to provide an environment between
70 and 75 degrees Fahrenheit (21 to 24 degrees Celsius).
c) The humidity shall be controlled to greater than or equal to 40% and
less than or equal to 60%. In extremely dry climates, a humidifier
may be necessary.
d) The climate control system must be capable of handling a heat load of
1.5 kilowatts.
e) All returns to the central HVAC system must be capable of being
sealed by isolation dampers from other areas in case of a gas leak.
EXHIBIT F
---------
LADARVISION SYSTEM SITE REQUIREMENTS
4. ELECTRICAL
a) There must be a dedicated 120 VAC 20 Amp or 220 VAC 13 Amp, 50-60 Hz
electrical outlet accessible to the foot of the System. Two
additional outlets are required for the remote modem and printer.
b) Additional outlets may be required for air purifiers, microkeratomes,
humidifiers and other devices.
c) Ability to dim the lights is recommended.
5. CLEANING
a) The optical components of the System are very sensitive to airborne
chemicals that are produced by cleaning supplies. An unscented soap
solution must be used to clean the floor, walls, cabinets.
b) The room cannot be painted within 2 weeks of the planned installation.
6. COMMUNICATIONS
a) There must be a dedicated direct dial phone line (tone) for the
internal modem of the LADARVision-Registered Trademark- System.
b) The phone line cannot share access with another modem or fax machine.
There cannot be a connection to an internal network phone system,
multi-extension or business phone configuration.
c) A 1FB analog phone line should be installed close to the electrical
outlet.
7. ACCESS
a) Access for the LADARVision-Registered Trademark- System from the
delivery truck to the room must be reasonable with no tight turns or
obstructions.
b) The doors leading from the delivery truck to the room must be at
least 36 inches (91 centimeters) wide.
c) If an elevator must be used to reach the room, then it must be at
least 95 inches (241 centimeters) long and 36 inches (91 centimeters)
wide.
EXHIBIT F
---------
LADARVISION SYSTEM SITE REQUIREMENTS
[GRAPHIC]
Figure 1 - System Layout Floor Plan Recommendations
FDA APPROVES AUTONOMOUS TECHNOLOGIES' LADARVISION-Registered Trademark- SYSTEM;
COMPANY ANNOUNCES U.S. PRODUCT LAUNCH
ORLANDO, FLA. (NOVEMBER 3, 1998) - AUTONOMOUS TECHNOLOGIES CORPORATION
(NASDAQ NM: ATCI) today announced that the U.S. Food and Drug Administration
(FDA) has approved the Company's LADARVision-Registered Trademark- System,
for the correction of nearsightedness and astigmatism. The Company's
LADARVision System is the first and only U.S. approved system to incorporate
a small spot shaping and eye tracking system into a surgical system. The FDA
approved the LADARVision System for the treatment of mild to moderate
nearsightedness
(-1.00 to -10.00 diopters) with or without astigmatism (up to -4.00 diopters)
with photorefractive keratectomy (PRK).
Myopia, or nearsightedness, occurs when light rays are focused in front of
- instead of on - the retina, and the person cannot see distant objects
clearly. Astigmatism results in light rays being focused at different points
in front of the retina. In both cases, blurred vision results.
The Autonomous LADARVision System uses an ultraviolet excimer laser to
change the shape of the cornea which makes it possible for the eye to focus
properly. For example, in the treatment of myopia, the laser is used to
remove tissue from the cornea in order to flatten its shape. The correction
of astigmatism requires the laser to remove tissue in a more complex pattern.
Both procedures require precise shaping of the cornea which depends on
accurate placement of a laser beam. Without a system to track eye movement,
any eye movement can affect the placement of the laser beam. By tracking eye
movement, the LADARVision System maintains accurate placement of its laser
beam.
The LADARVision System uses a small diameter (LESS THAN 1 mm) excimer laser
beam that is delivered to the cornea in a calculated pattern of
non-sequential pulses. According to Xxxxxx Xxxxxx, M.D., Ph.D., Vice
President for Research at Autonomous, "The LADARVision System sculpts the
cornea by delivering hundreds to thousands of excimer laser pulses to the eye
in a complex pattern of spatially overlapping spots." Xx. Xxxxxx added, "The
accuracy of the small spot treatment is brought about by the unique
eye-tracking features of the LADARVision System. The tracker guided system
uses technology originally developed by Autonomous for the Strategic Defense
Initiative, or `Star Wars,' and is able to catch, track, and compensate for
rapid eye movements. Using proprietary laser radar, or LADAR technology, the
tracker repositions mirrors in the laser beam path and ensures precise
delivery of the treatment laser beam."
Previously approved laser systems require patients to minimize eye movement
during surgery by voluntarily fixating their eyes on a small light located
just above the patient. Xxxxxxxxxx XxXxxxxx, M.D., Medical Director and
consultant to Autonomous, explains, "When the average person fixates on
something, he or she has five saccadic eye movements per second. The
LADARVision System's ability to follow eye movements in real time greatly
reduces the dependency of stable fixation by the patient and allows for
precise corneal shaping."
Xxxxx Xxxx, Chairman and CEO of Autonomous, comments: "Physicians now have a
powerful and truly differentiated product alternative to further drive their
laser vision correction practice. Our FDA approval is for a broad indication
for use supported by excellent clinical results in the labeling. In addition,
the financial and business strength that the Summit merger brings to
Autonomous, along with the royalty free patent license and strong service
organization, allows Autonomous to set high goals in capturing procedure
market share. We are highly encouraged by our clinical trial progress in
LASIK, Hyperopia with Astigmatism and our R&D efforts in CustomCornea-TM-. I
believe physicians recognize that the LADARVision System is the technology
platform for the future of this industry. Furthermore, no other company
offers physicians a per-procedure business model with a stronger partnership
commitment to individual practice success. Finally, I would like to
congratulate and thank the Autonomous Team: our employees, consultants,
clinical investigators and vendors for their highly dedicated contributions
that made reaching this milestone possible."
Vision correction is among the largest medical markets, with approximately
136 million people in the U.S. using eyeglasses or contact lenses. Within
this group, approximately 60 million are myopic. Industry sources estimate
that Americans spend approximately $13 billion at retail on eyeglasses,
contact lenses and other vision correction products and services annually.
According to Xxxxxxx Xxxxxxx, an industry analyst with Xxxxxxxxx & Xxxxx, the
laser vision correction (LVC) market in the United States is growing rapidly.
So far this year, the industry is on a pace to achieve an estimated 375,000
procedures compared to about 200,000 in 1997 and 70,000 in 1996. Xx. Xxxxxxx
expects that annual U.S. procedures could reach 675,000 by the year 2000.
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Autonomous plans to offer its LADARVision System to physicians on a
per-procedure service fee basis. The fee will be based on the physician's
procedure volume and will not contain, or be subject to, any third party
patent royalties once the announced merger is completed. The Company's
pricing strategy significantly reduces the initial capital investment
required by the physician, and eliminates the highly variable operating and
upgrade costs experienced by many LVC practitioners. The new strategy also
allows Autonomous to partner with physicians and grow together as practice
volumes increase. Laser vision correction practices will also benefit from a
comprehensive, Company sponsored, Technology Enhanced Area Marketing program,
or "TEAM". This customized marketing program is designed to leverage the
unique technology and differentiate the Autonomous user from other
competitive sites. The TEAM goal is to use this differentiation to build
procedure volume.
Autonomous has completed staffing its sales and marketing team and plans to
begin an aggressive marketing campaign beginning at the American Academy of
Ophthalmology Annual Conference which begins next week in New Orleans.
Autonomous will be featured with its strategic partner, CIBA Vision during
the conference.
Autonomous announced on October 1, 1998 that it has agreed to be acquired by
Summit Technology subject to the approval of the shareholders of both
companies. Summit has agreed to acquire all of the outstanding shares of
Autonomous in exchange for 11.65 million shares of Summit common stock and an
equal value of cash, up to $50 million. The actual value of the transaction
will not be determinable until closing, which is currently expected to be
within the next three months.
Autonomous designs, develops and markets next generation excimer laser
instruments for laser vision correction. The company's LADARVision System
combines high-speed, laser radar eye tracking with precisely controlled small
beam shaping technology. For more information, contact Autonomous
Technologies at 0000 Xxxxxxxxx Xxxxx, Xxxxxxx, XX 00000 (407) 384-1600, or
visit us on the web at xxx.xxxxxxxxxx.xxx.
------------------
THIS PRESS RELEASE CONTAINS FORWARD-LOOKING STATEMENTS WITHIN THE MEANING OF
SECTION 27A OF THE SECURITIES ACT OF 1933 AND SECTION 21E OF THE SECURITIES
EXCHANGE ACT OF 1934. ACTUAL RESULTS COULD DIFFER MATERIALLY FROM THOSE
PROJECTED IN THE FORWARD-LOOKING STATEMENTS AS A RESULT OF A NUMBER OF
IMPORTANT FACTORS, INCLUDING: A DECLINE IN THE PRICE OF SUMMIT STOCK PRIOR TO
THE CLOSING; AND THAT THERE ARE NO ASSURANCES THE SHAREHOLDERS OF BOTH
COMPANIES WILL TAKE THE NECESSARY ACTIONS TO COMPLETE THE ACQUISITION; AND
THAT THE COMPANY MAY NOT RECEIVE THE REGULATORY APPROVAL NECESSARY TO
COMPLETE THE ACQUISITION; AND THAT THE COMPETITIVE RESPONSES MAY OCCUR
PREVENTING THE ACHIEVEMENT OF INCREASED MARKET SHARE. FOR A DISCUSSION OF THE
IMPORTANT FACTORS THAT COULD AFFECT THE COMPANY'S RESULTS, PLEASE REFER TO
THE OVERVIEW SECTION, THE MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS, AND THE RISK FACTORS SECTION IN THE
COMPANY'S ANNUAL REPORT ON FORM 10-K AS AMENDED.
***
COMPANY CONTACT: INVESTOR RELATIONS CO
Autonomous Technologies Corporation Xxxxxxx/Heilshorn & Asso
Xxxxx Xxxx B
Chairman & CEO Xxxxx@
xxxxxxxxx@xxxxxxxxxx.xxx ------
------------------------ (310)
Xxxxxxxx Xxxxxxx Xxxx M
Manager of Investor Relations Xxxx@
xxxxxxxx@xxxxxxxxxx.xxx -----
----------------------- (212)
(000) 000-0000
www
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